,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois 0,32343462,Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial.,"BACKGROUND AND PURPOSE Hereditary transthyretin (hATTR) amyloidosis causes progressive polyneuropathy resulting from transthyretin (TTR) amyloid deposition throughout the body, including the peripheral nerves. The efficacy and safety of inotersen, an antisense oligonucleotide inhibitor of TTR protein production, were demonstrated in the pivotal NEURO-TTR study in patients with hATTR polyneuropathy. Here, the long-term efficacy and safety of inotersen are assessed in an ongoing open-label extension (OLE) study. METHODS Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004). Efficacy assessments included the modified Neuropathy Impairment Score plus seven neurophysiological tests composite score (mNIS + 7), the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN) questionnaire total score and the Short-Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score. Safety and tolerability were also assessed. RESULTS Overall, 97% (135/139) of patients who completed NEURO-TTR enrolled in the OLE. Patients who received inotersen for 39 cumulative months in NEURO-TTR and the OLE continued to show benefit; patients who switched from placebo to inotersen in the OLE demonstrated improvement or stabilization of neurological disease progression by mNIS + 7, Norfolk QOL-DN and SF-36 PCS. No new safety concerns were identified. There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. CONCLUSION Inotersen slowed disease progression and reduced deterioration of quality of life in patients with hATTR polyneuropathy. Early treatment with inotersen resulted in greater long-term disease stabilization than delayed initiation. Routine platelet and renal safety monitoring were effective; no new safety signals were observed.",2020,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. ","['Patients With Hereditary Transthyretin Amyloidosis', 'Patients who completed NEURO-TTR were eligible to enroll in the OLE (NCT02175004', 'patients with hATTR polyneuropathy']","['OLE', 'placebo']","['Safety and tolerability', 'risk for grade 4 thrombocytopenia or severe renal events', 'stabilization of neurologic disease progression by mNIS+7, Norfolk QOL-DN, and SF-36 PCS', 'disease progression and reduced deterioration of quality of life', 'greater long-term disease stabilization', 'modified Neuropathy Impairment Score +7 neurophysiologic tests composite score (mNIS+7), Norfolk Quality of Life-Diabetic Neuropathy questionnaire total score (Norfolk QOL-DN), and the Short Form 36 Health Survey (SF-36) Physical Component Summary score (PCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0454866', 'cui_str': 'Norfolk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0250599,"There was no evidence of increased risk for grade 4 thrombocytopenia or severe renal events with increased duration of inotersen exposure. ","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Wang', 'Affiliation': 'University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'CEPARM, Amyloidosis Referral Center, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Plante-Bordeneuve', 'Affiliation': 'CHU Henri Mondor, Creteil, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barroso', 'Affiliation': 'FLENI, Buenos Aires, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Merlini', 'Affiliation': 'Amyloidosis Center, IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'CHULN, Hospital Santa Maria and Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwoh', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, MA, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Benson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gertz', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.14285'] 1,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background: DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D). Research Design and Methods: We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications. Results: There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004. Conclusion: Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ': DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481'] 2,32339320,Evaluation of clinical effects of microsurgical subinguinal varicocelectomy with and without testicular delivery.,"The aim of this study was to access whether microsurgical subinguinal varicocelectomy (MSV) with testicular delivery has a better therapeutic effect than MSV without testicular delivery, including semen quality, serum testosterone (T) level and International Index of Erectile Function (IIEF)-5 score in infertility male patients with varicocele. In this prospective study, 181 patients were included and they chose the treatment by themselves. A total of 114 patients who received MSV without testicular delivery (TD) and 67 patients who received MSV with TD were followed-up 6 months after the operation. Semen parameters, serum T level and IIEF-5 scores were recorded before and 6 months after the operation. Results showed that MSV with or without TD could improve semen quality, serum T level and IIEF-5 score. For semen quality 6 months after the operation, there was no significant difference between patients received MSV with or without TD. But in patients with varicocele of grade III, MSV without testicular delivery improved the sperm concentration and motility more. And patients received MSV without TD have a higher T level 6 months after the operation, especially in patients ≤27 years. MSV with TD is not superior to that without, but this should be verified in more samples and a better designed randomised controlled study in the future.",2020,"Results showed that MSV with or without TD could improve semen quality, serum T level and IIEF-5 score.","['infertility male patients with varicocele', '114 patients who received MSV without testicular delivery (TD) and 67 patients who received', '181 patients were included and they chose the treatment by themselves']","['MSV without TD', 'MSV with TD', 'microsurgical subinguinal varicocelectomy with and without testicular delivery', 'microsurgical subinguinal varicocelectomy (MSV) with testicular delivery']","['semen quality, serum testosterone (T) level and International Index of Erectile Function (IIEF)-5 score', 'Semen parameters, serum T level and IIEF-5 scores', 'semen quality, serum T level and IIEF-5 score']","[{'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0194985', 'cui_str': 'Excision of varicocele'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",181.0,0.0329089,"Results showed that MSV with or without TD could improve semen quality, serum T level and IIEF-5 score.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Operating Room, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Guangcheng', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xiang', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}, {'ForeName': 'Boxin', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'Department of Urology, Second Affiliated Hospital of Soochow University, Jiangsu, China.'}]",Andrologia,['10.1111/and.13605'] 3,32276071,Acute alcohol intoxication and expectations reshape the spatiotemporal functional architecture of executive control.,"While the deleterious effects of acute ethyl alcohol intoxication on executive control are well-established, the underlying spatiotemporal brain mechanisms remain largely unresolved. In addition, since the effects of alcohol are noticeable to participants, isolating the effects of the substance from those related to expectations represents a major challenge. We addressed these issues using a double-blind, randomized, parallel, placebo-controlled experimental design comparing the behavioral and electrical neuroimaging acute effects of 0.6 vs 0.02 ​g/kg alcohol intake recorded in 65 healthy adults during an inhibitory control Go/NoGo task. Topographic ERP analyses of covariance with self-reported dose expectations allowed to dissociate their neurophysiological effects from those of the substance. While alcohol intoxication increased response time variability and post-error slowing, bayesian analyses indicated that it did not modify commission error rates. Functionally, alcohol induced topographic ERP modulations over the periods of the stimulus-locked N2 and P3 components, arising from pre-supplementary motor and anterior cingulate areas. In contrast, alcohol decreased the strength of the response-locked anterior cingulate error-related component but not its topography. This pattern indicates that alcohol had a locally specific influence within the executive control network, but disrupted performance monitoring processes via global strength-based mechanisms. We further revealed that alcohol-related expectations induced temporally specific functional modulations of the early N2 stimulus-locked medio-lateral prefrontal activity, a processing phase preceding those influenced by the actual alcohol intake. Our collective findings thus not only reveal the mechanisms underlying alcohol-induced impairments in impulse control and error processing, but also dissociate substance- from expectations- related functional effects.",2020,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.",['65 healthy adults during an inhibitory control Go/NoGo task'],['placebo'],['strength of the response-locked anterior cingulate error'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",65.0,0.0365488,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.","[{'ForeName': 'Farfalla', 'Initials': 'F', 'LastName': 'Ribordy Lambert', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Corentin A', 'Initials': 'CA', 'LastName': 'Wicht', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Spierer', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland. Electronic address: lucas.spierer@unifr.ch.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116811'] 4,32339664,"Effect of prefrontal tDCS on resting brain fMRI graph measures in Alcohol Use Disorders: A randomized, double-blind, sham-controlled study.","OBJECTIVES Transcranial Direct Current Stimulation (tDCS) is a promising new adjuvant approach in the treatment of Alcohol Use Disorders (AUDs) that has the potential to ameliorate the aberrations secondary to chronic alcohol use. In this study, using a randomized, double-blind, sham-controlled, parallel-arm design, we examined the effects of prefrontal tDCS on resting-state functional magnetic resonance imaging (rsfMRI) and its correlates with impulsivity and time to first lapse in subjects with AUDs. METHODS Patients with AUD as per DSM-5 criteria were randomly allocated to receive a five-day course of either verum-tDCS (n = 12) or sham-tDCS (n = 12). Of them, 21 patients (verum/sham = 11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions. Outside the scanner, subjects also performed the Stop-Signal Task at two time-points (baseline and post-intervention), which provided a measure of changes in impulsivity following tDCS. After completion of the post-intervention scan, all subjects were discharged and were followed-up for 90 days post-discharge or until lapse to first alcohol use. RESULTS Graph theoretical analysis of rsfMRI data revealed that verum-tDCS (but not sham) resulted in a significant increase in the global efficiency of brain networks with a concurrent significant reduction in global clustering; network-based statistical analysis identified a significant increase in the functional connectivity of a specific sub-network involving prefrontal regions. Furthermore, increased global efficiency of brain networks following verum tDCS predicted a significantly reduced likelihood of relapse. In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity. CONCLUSIONS The present study adds further support to the increasing evidence base for the clinical utility of tDCS in AUDs. Importantly, we observed improvement in both whole-brain network efficiency as well as inter-regional connectivity within a specific local prefrontal sub-network that is relevant to the neurobiology of AUDs. Replication and extension of these promising leads from the present study can facilitate clinical translation of tDCS, given its advantages (i.e. safety, cost-effectiveness, administration ease with potential for remotely-supervised / home-based application) for treating patients with AUDs.",2020,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity. ","['subjects with AUDs', 'Patients with AUD as per DSM-5 criteria', 'Alcohol Use Disorders', '21 patients (verum/sham\u202f=\u202f11/10) participated in both baseline and post-intervention 10-min rsfMRI sessions']","['prefrontal tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'verum-tDCS (n\u202f=\u202f12) or sham-tDCS']","['resting brain fMRI graph measures', 'likelihood of relapse', 'global efficiency of brain networks', 'functional connectivity of a specific sub-network involving prefrontal regions']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.15234,"In addition, a reduction in the global clustering had a significant positive correlation with a reduction in the measure of impulsivity. ","[{'ForeName': 'Bharath', 'Initials': 'B', 'LastName': 'Holla', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Jitendriya', 'Initials': 'J', 'LastName': 'Biswal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Neuroimaging and Interventional Radiology, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Benegal', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India. Electronic address: gvs@nimhans.ac.in.'}, {'ForeName': 'Prabhat Kumar', 'Initials': 'PK', 'LastName': 'Chand', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Departments of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.109950'] 5,32339910,Supporting patients and carers affected by pancreatic cancer: A feasibility study of a counselling intervention.,"PURPOSE Patients with pancreatic cancer have extremely high unmet psychological and physical needs. Family carers of these patients have even higher levels of distress than patients. Our purpose was to assess the feasibility and acceptability of a counselling intervention in patients diagnosed with pancreatic cancer and their carers. METHODS We conducted a single-arm feasibility study of the PREPARES (Patients and RElatives affected by PAncreatic cancer: Referral, Education and Support) pilot intervention. Patient and carer participants received up to nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology. The intervention, informed by self-efficacy theory, involved components to assess and address care needs, and provide feedback to clinicians. Feasibility was measured using participation and retention rates. Participants completed semi-structured interviews at the end of the intervention about acceptability. These were analysed using thematic analysis. RESULTS Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively). Most participants (eight) completed all nine counselling sessions; two chose to receive fewer sessions and two were discontinued requiring more intensive psychiatric support. The intervention was highly acceptable. Participants unanimously preferred the telephone over video-conferencing and to receive counselling separately from their carer/patient. The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care. Suggested improvements included a welcome pack about their nurse-counsellor and that sessions should continue beyond nine sessions if required. CONCLUSIONS The PREPARES intervention was feasible and highly acceptable. This low-cost intervention provided much-needed support to people affected by this devastating disease.",2020,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","['patients and carers affected by pancreatic cancer', 'Patients with pancreatic cancer', 'Twelve people participated: five patients and seven carers (38% and 50% participation rates respectively', 'patients diagnosed with pancreatic cancer and their carers', 'Patients and RElatives affected by PAncreatic cancer']","['nine counselling sessions delivered by a trained nurse via telephone and/or telehealth technology', 'counselling intervention', 'telephone over video-conferencing and to receive counselling separately from their carer/patient', 'PREPARES']","['feasibility and acceptability', ""nurse-counsellors' knowledge, care coordination and personalised care""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",12.0,0.0615602,"The main perceived benefits were emotional support, the nurse-counsellors' knowledge, care coordination and personalised care.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Chan', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Division of Cancer Services, Princess Alexandra Hospital, Metro South Hospital and Health Services, Brisbane, Australia.'}, {'ForeName': 'Patsy', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Gordon', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Eastgate', 'Affiliation': ""Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Aleksandra A', 'Initials': 'AA', 'LastName': 'Staneva', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Northfield', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Beebe', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wyld', 'Affiliation': ""School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Metro North Hospital and Health Services, Brisbane, Australia.""}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia; Faculty of Medicine, University of Queensland, Brisbane, Australia.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101729'] 6,32340121,Acute Caffeine Supplementation Does Not Improve Performance in Trained CrossFit ® Athletes.,"Caffeine's ergogenic effects persist during various exercise modalities; however, information establishing its efficacy during CrossFit ® protocols is limited. This study aimed to determine the effects of caffeine supplementation on CrossFit ® performance. Twenty CrossFit ® -trained men (age = 26.7 ± 6.2 years, experience = 3.7 ± 2.9 years) were randomized in a double-blind, crossover design. Participants completed two sessions separated by a seven-day washout period, 60 min after consuming 5 mg/kg body mass of caffeine or a placebo. In each session, participants completed as many rounds as possible in 20 min of five pull-ups, 10 push-ups, and 15 air squats. CrossFit ® performance was the total number of repetitions completed in 20 min. Paired-samples t-tests were used to compare CrossFit ® performance between caffeine and placebo conditions and to test for a potential learning effect between the first and second sessions. CrossFit ® performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions, p = 0.861). A significant learning effect was identified between the first and second sessions (452.4 ± 101 vs. 483.8 ± 106.5 repetitions, p = 0.001), with no significant effect of treatment order ( p = 0.438). Caffeine's ergogenic effect were not present during the CrossFit ® workout ""Cindy""; however, future research should include familiarization sessions and examine other CrossFit ® workouts in novice and women participants.",2020,"CrossFit ® performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions, ","['Trained CrossFit ® Athletes', 'Twenty CrossFit ® -trained men (age = 26.7 ± 6.2 years, experience = 3.7 ± 2.9 years']","['caffeine or a placebo', 'caffeine supplementation', 'Caffeine', 'Acute Caffeine Supplementation', 'placebo']","['CrossFit ® performance', 'learning effect']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.135352,"CrossFit ® performance was not significantly different during the caffeine condition compared to the placebo (468.6 ± 114.7 vs. 466.7 ± 94.3 repetitions, ","[{'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Stein', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Melitza', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Heinrich', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, Kansas State University, Manhattan, KS 66506, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040054'] 7,32340906,Assessment of conduction anesthesia effectiveness using the angulated needle approach for the inferior alveolar nerve block.,"BACKGROUND Ambulatory painless surgery is dependent on local anesthesia effectiveness. AIM Evaluating the anesthetic efficacy of the angulated needle approach (ANA) for the inferior alveolar nerve block (IANB). MATERIAL AND METHOD Group I received direct IANB; group II received indirect IANB; group III received the IANB with ANA. The quality of anesthesia score (QAS), numerical pain intensity score (NRS), onset time of full anesthesia (OT), and perianesthetic complications were measured. RESULTS Ninety patients (mean age: 37.47 ± 18.90, p = 0.027) of both sexes were split into three equal groups. Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016). Group II had the statistically significant highest NRS values relative to group I (p = 0.002) and group III (p = 0.000001). The shortest OT occurred in group I, when compared to group II (p = 0.000484) and group III (p = 0.000498). The transient syncope and positive aspiration occurred in single cases. CONCLUSION The ANA for the IANB could successfully serve as a ""first choice"", or as an ""addendum technique"" in the cases of multiple failed attempts for direct and indirect IANB techniques.",2020,"Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016).","['Ninety patients (mean age: 37.47\xa0±\xa018.90, p\xa0=\xa00.027) of both sexes']","['IANB with ANA', 'angulated needle approach (ANA', 'indirect IANB', 'direct IANB']","['conduction anesthesia effectiveness', 'anesthetic efficacy', 'quality of anesthesia score (QAS), numerical pain intensity score (NRS), onset time of full anesthesia (OT), and perianesthetic complications', 'QAS values', 'transient syncope and positive aspiration', 'NRS values', 'shortest OT', 'success rate']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",90.0,0.0221863,"Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016).","[{'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Tijanić', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burić', 'Affiliation': 'Intern, Clinic of Stomatology, Niš, Serbia.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Stojanović', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Burić', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia. Electronic address: nburic@yahoo.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.03.010'] 8,32340871,Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study.,"BACKGROUND Aspirin (ASA) anti-platelet therapy is mandated with left ventricular assist devices (LVADs) to prevent hemocompatibility-related adverse events (HRAEs). However, the optimal dose of ASA with HeartMate 3 (HM3) LVAD is unknown. METHODS In an exploratory analysis of HM3-supported patients in the MOMENTUM 3 study (NCT02224755), 2 groups were analyzed: usual-dose (325 mg) and low-dose (81 mg) ASA with anti-coagulation targeted to an international normalized ratio of 2.0 to 3.0. Exclusion criteria included patients not receiving either ASA 81 mg or 325 mg, those with HRAEs ≤7 days after device implantation, and those receiving >1 anti-platelet agent. The primary end-point was survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events) at 2 years. RESULTS Overall, 321 HM3 patients (usual-dose: n = 141, low-dose: n = 180) were included in this analysis. Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA. At 2 years, a similar proportion of patients in the usual- and low-dose groups (43.4% vs 45.3%, p = 0.94) met the primary end-point. There were no differences in survival free from hemorrhagic (usual-dose: 54.4% vs low-dose: 51.7%, p = 0.42) or thrombotic (usual-dose: 76.8% vs low-dose: 75.7%, p = 0.92) events. CONCLUSIONS Usual- and low-dose ASA revealed similar rates of bleeding and thrombotic events in HM3 LVAD-supported patients within the MOMENTUM 3 trial. Whether ASA therapy provides any meaningful therapeutic effect in patients treated by the HM3 LVAD remains to be determined.",2020,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","['321 HM3 patients (usual-dose: n\u202f=\u202f141, low-dose: n\u202f=\u202f180']","['Aspirin (ASA) anti-platelet therapy', 'ASA', 'aspirin']","['thrombotic', 'survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events', 'rates of bleeding and thrombotic events', 'survival free from hemorrhagic']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}]",180.0,0.064419,"Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA.","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Paolo C', 'Initials': 'PC', 'LastName': 'Colombo', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cleveland', 'Affiliation': 'Department of Surgery, University of Colorado Hospital, Aurora, Colorado.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Samer S', 'Initials': 'SS', 'LastName': 'Najjar', 'Affiliation': 'Department of Medicine, Medstar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Nahush A', 'Initials': 'NA', 'LastName': 'Mokadam', 'Affiliation': 'Department of Surgery, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Surgery, Ochsner Medical Center, New Orleans, Louisiana.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Crandall', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Division of Cardiology Department of Medicine, Abbott, Chicago, Illinois.'}, {'ForeName': 'Ulrich P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York. Electronic address: ujorde@montefiore.org.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.001'] 9,32341121,Dopamine and Risky Decision-Making in Gambling Disorder.,"Gambling disorder is a behavioral addiction associated with impairments in value-based decision-making and cognitive control. These functions are thought to be regulated by dopamine within fronto-striatal circuits, but the role of altered dopamine neurotransmission in the etiology of gambling disorder remains controversial. Preliminary evidence suggests that increasing frontal dopamine tone might improve cognitive functioning in gambling disorder. We therefore examined whether increasing frontal dopamine tone via a single dose of the catechol- O -methyltransferase (COMT) inhibitor tolcapone would reduce risky choice in human gamblers ( n  = 14) in a randomized double-blind placebo-controlled crossover study. Data were analyzed using hierarchical Bayesian parameter estimation and a combined risky choice drift diffusion model (DDM). Model comparison revealed a nonlinear mapping from value differences to trial-wise drift rates, confirming recent findings. An increase in risk-taking under tolcapone versus placebo was about five times more likely, given the data, than a decrease [Bayes factor (BF) = 0.2]. Examination of drug effects on diffusion model parameters revealed that an increase in the value dependency of the drift rate under tolcapone was about thirteen times more likely than a decrease (BF = 0.073). In contrast, a reduction in the maximum drift rate under tolcapone was about seven times more likely than an increase (BF = 7.51). Results add to previous work on COMT inhibitors in behavioral addictions and to mounting evidence for the applicability of diffusion models in value-based decision-making. Future work should focus on individual genetic, clinical and cognitive factors that might account for heterogeneity in the effects of COMT inhibition.",2020,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","['gambling disorder', 'human gamblers (n=14']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'Dopamine', 'frontal dopamine tone via the catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone vs. placebo', 'tolcapone', 'placebo']","['maximum drift rate under tolcapone', 'risky choice', 'value-dependency of the drift rate under tolcapone', 'cognitive functioning']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0953733,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Biological Psychology, University of Cologne, Cologne 50923, Germany jan.peters@uni-koeln.de.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}]",eNeuro,['10.1523/ENEURO.0461-19.2020'] 10,32342562,Randomized Clinical Trial of First-Line Genome Sequencing in Pediatric White Matter Disorders.,"OBJECTIVE Genome sequencing (GS) is promising for unsolved leukodystrophies, but its efficacy has not been prospectively studied. METHODS A prospective time-delayed crossover design trial of GS to assess the efficacy of GS as a first-line diagnostic tool for genetic white matter disorders took place between December 1, 2015 and September 27, 2017. Patients were randomized to receive GS immediately with concurrent standard of care (SoC) testing, or to receive SoC testing for 4 months followed by GS. RESULTS Thirty-four individuals were assessed at interim review. The genetic origin of 2 patient's leukoencephalopathy was resolved before randomization. Nine patients were stratified to the immediate intervention group and 23 patients to the delayed-GS arm. The efficacy of GS was significant relative to SoC in the immediate (5/9 [56%] vs 0/9 [0%]; Wild-Seber, p < 0.005) and delayed (control) arms (14/23 [61%] vs 5/23 [22%]; Wild-Seber, p < 0.005). The time to diagnosis was significantly shorter in the immediate-GS group (log-rank test, p = 0.04). The overall diagnostic efficacy of combined GS and SoC approaches was 26 of 34 (76.5%, 95% confidence interval = 58.8-89.3%) in <4 months, greater than historical norms of <50% over 5 years. Owing to loss of clinical equipoise, the trial design was altered to a single-arm observational study. INTERPRETATION In this study, first-line GS provided earlier and greater diagnostic efficacy in white matter disorders. We provide an evidence-based diagnostic testing algorithm to enable appropriate clinical GS utilization in this population. ANN NEUROL 2020.",2020,"The time to diagnosis was significantly shorter in the immediate-GS group (log rank test, p=0.04).","['genetic white matter disorders took place between 12/01/2015 - 09/27/2017', 'Pediatric White Matter Disorders', 'Nine patients stratified to the immediate intervention group and 23 patients to the delayed-GS arm']","['GS immediately with concurrent standard of care (SoC) testing, or to receive SoC testing for four months followed by GS']","['time to diagnosis', 'diagnostic efficacy', 'overall diagnostic efficacy']","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",34.0,0.0792432,"The time to diagnosis was significantly shorter in the immediate-GS group (log rank test, p=0.04).","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Vanderver', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Departments of Neurology and Neurosurgery, Pediatrics, and Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Helman', 'Affiliation': 'Institute for Molecular Bioscience, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sherbini', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Boeck', 'Affiliation': 'Child Neurology Consultants of Austin, Austin, Texas, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'Family Medicine, Broadlands Family Practice at Ashburn, Ashburn, Virginia, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Demarest', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Dobbins', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Emrick', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Fraser', 'Affiliation': ""Division of Genetics and Metabolism, Rare Disease Institute, Children's National Health System, Washington, District of Columbia, USA.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Masser-Frye', 'Affiliation': ""Rady Children's Hospital, San Diego, California, USA.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hayward', 'Affiliation': 'Department of Pediatrics, Kaiser Oakland, Oakland, California, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Karmarkar', 'Affiliation': ""Department of Neurology, Le Bonheur Children's Hospital, Memphis, Tennessee, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Division of Neurology, Department of Pediatrics, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Mirrop', 'Affiliation': ""Division of Neurology, Children's Hospital of Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mitchell', 'Affiliation': 'Pediatric Associates of Austin, Austin, Texas, USA.'}, {'ForeName': 'Sheel', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Clinical Neurology, Washington University Clinical Associates,, St Louis, Missouri, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Sherr', 'Affiliation': 'Department of Neurology, University of California, San Francisco School of Medicine, San Francisco, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'van Haren', 'Affiliation': 'Department of Neurology, Stanford University Medical Center, Stanford, California, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Waters', 'Affiliation': 'Pediatric Associates of Stockton, Stockton, California, USA.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Wilson', 'Affiliation': 'Division of Pediatric Neurology, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Zhorne', 'Affiliation': 'Stead Family Department of Pediatrics, Carver College of Medicine, University of Iowa Health Care, Iowa City, Iowa, USA.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Schiffmann', 'Affiliation': 'Institute of Metabolic Disease, Baylor Scott & White Research Institute, Dallas, Texas, USA.'}, {'ForeName': 'Marjo S', 'Initials': 'MS', 'LastName': 'van der Knaap', 'Affiliation': 'Department of Child Neurology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pizzino', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Dubbs', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Cas', 'Initials': 'C', 'LastName': 'Simons', 'Affiliation': 'Institute for Molecular Bioscience, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Taft', 'Affiliation': 'Illumina, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25757'] 11,32280342,Using Media to Promote Public Awareness of Early Detection of Kaposi's Sarcoma in Africa.,"Background Despite its hallmark cutaneous presentation, most Kaposi's sarcoma (KS) in Africa is diagnosed too late for effective treatment. Early diagnosis will only be achievable if patients with KS present earlier for care. We hypothesized that public awareness about KS can be enhanced through exposure to common media. Methods We developed educational messages regarding early detection of KS for the general African public portraying a three-part theme: ""Look"" (regularly examine one's skin/mouth), ""Show"" (bring to the attention of a healthcare provider any skin/mouth changes), and ""Test"" (ask for a biopsy for definitive diagnosis). We packaged the messages in three common media forms (comic strips, radio, and video) and tested their effect on increasing KS awareness among adults attending markets in Uganda. Participants were randomized to a single exposure to one of the media and evaluated for change in KS-related knowledge and attitudes. Results Among 420 participants, media exposure resulted in increased ability to identify KS (from 0.95% pretest to 46% posttest); awareness that anyone is at risk for KS (29% to 50%); belief that they may be at risk (63% to 76%); and knowledge that definitive diagnosis requires biopsy (23% to 51%) (all p < 0.001). Most participants (96%) found the media culturally appropriate. Conclusion Exposure to media featuring a theme of ""Look,"" ""Show,"" and ""Test"" resulted in changes in knowledge and attitudes concerning KS among the general public in Uganda. High incidence and poor survival of KS in Africa are an impetus to further evaluate these media, which are freely available online.",2020,"Results Among 420 participants, media exposure resulted in increased ability to identify KS (from 0.95% pretest to 46% posttest); awareness that anyone is at risk for KS (29% to 50%)","[""Kaposi's Sarcoma in Africa"", 'adults attending markets in Uganda', '420 participants']",[],"['KS awareness', 'ability to identify KS']","[{'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C4517774', 'cui_str': '420'}]",[],"[{'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",420.0,0.0543143,"Results Among 420 participants, media exposure resulted in increased ability to identify KS (from 0.95% pretest to 46% posttest); awareness that anyone is at risk for KS (29% to 50%)","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Laker-Oketta', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Butler', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Kadama-Makanga', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Inglis', 'Affiliation': 'Jive Media Africa, Pietermaritzburg, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wenger', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Katongole-Mbidde', 'Affiliation': 'Uganda Virus Research Institute, Entebbe, Uganda.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Maurer', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}]",Journal of oncology,['10.1155/2020/3254820'] 12,32346896,Effects of virtual reality on moods in community older adults. A multicenter randomized controlled trial.,"INTRODUCTION Virtual reality (VR) technology is a potential method to use in cognitive intervention, but the use of VR in cognitive stimulation intervention for older adults has not been investigated. Therefore, the aim of this study was to investigate the mood change of older adults after participating in the VR cognitive stimulation activity. METHODS This is a multicenter randomized controlled, cross-over trial. The intervention was a VR cognitive stimulation activity, and the control was a paper-and-pencil activity. The participants were older adults with age over 60 and recruited in the elderly community centers. The Positive and Negative Affect Score (PANAS) was used to measure mood change. Mean difference (MD) with 95% confidence interval (95% CI) was calculated. The Simulator sickness questionnaire was used to measure adverse events. RESULTS A total of 236 participants from 19 community centers were recruited. After the VR activity, the participants had a significant increase in total PANAS positive affect score (MD = 2.09, 95% CI = 0.69 to 3.49), and a significant reduction in total negative affect score (MD = -1.99, 95% CI = -2.55 to -1.43). The reduction in negative affect score was significantly larger in VR activity than paper-and-pencil activity (MD = -0.48, 95% CI = -0.98 to 0.00). Besides, only three participants reported severe advance events after VR activity. CONCLUSIONS The use of VR technology is well accepted by older adults. Therefore, the use of VR technology through smartphone and a mobile app can be a potential method for future cognitive training interventions.",2020,"The reduction in negative affect score was significantly larger in VR activity than paper-and-pencil activity (MD = -0.48, 95% CI = -0.98 to 0.00).","['older adults', 'participants were older adults with age over 60 and recruited in the elderly community centres', 'Community Older Adults', 'older adults after participating in the VR cognitive stimulation activity', '236 participants from 19 community centres were recruited']","['Virtual-reality (VR) technology', 'Virtual Reality', 'VR technology']","['total PANAS positive affect score', 'Mean difference (MD', 'severe advance events', 'total negative affect score', 'VR activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",236.0,0.0575634,"The reduction in negative affect score was significantly larger in VR activity than paper-and-pencil activity (MD = -0.48, 95% CI = -0.98 to 0.00).","[{'ForeName': 'Joyce Y C', 'Initials': 'JYC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tak Kit', 'Initials': 'TK', 'LastName': 'Chan', 'Affiliation': 'Stanley Ho Big Data Decision Analytics Research Centre, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Michael P F', 'Initials': 'MPF', 'LastName': 'Wong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Ruby S M', 'Initials': 'RSM', 'LastName': 'Cheung', 'Affiliation': 'Stanley Ho Big Data Decision Analytics Research Centre, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Karen K L', 'Initials': 'KKL', 'LastName': 'Yiu', 'Affiliation': 'Stanley Ho Big Data Decision Analytics Research Centre, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Kelvin K F', 'Initials': 'KKF', 'LastName': 'Tsoi', 'Affiliation': 'Stanley Ho Big Data Decision Analytics Research Centre, The Chinese University of Hong Kong, Shatin, Hong Kong.'}]",International journal of geriatric psychiatry,['10.1002/gps.5314'] 13,32347143,"HIV Self-Testing Can Be Liberating to HIV-Positive Women and Their Sexual Partners: A Qualitative Study in Kisumu, Western Kenya.","BACKGROUND Nearly half of Kenyan men with HIV-positive partners do not know their partner's status. We carried out a qualitative substudy to explore the experiences of a sample of HIV-positive women when distributing HIV self-tests (HIVST) to their sexual partners. METHODS HIV-positive women were invited for in-depth interviews to share their experiences in offering HIVST to their partners and how self-testing impacted their relationships. RESULTS Two hundred ninety-seven women were randomized to HIVST, 12 of whom self-reported being HIV positive and 11 participated in the interview. Self-testing procedures and interpretation of results were well understood. Participants were strategic in approaching their partners, thus avoided partner violence. Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. CONCLUSIONS Giving HIV-positive women HIVST kits to distribute to their male partners is feasible and safe. Providers who have challenges reaching male partners with testing should consider HIVST.",2020,"Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. ","['Kisumu, Western Kenya', 'Kenyan men with HIV-positive partners', 'HIV-Positive Women and Their Sexual Partners', 'HIV-positive women when distributing HIV self-tests (HIVST) to their sexual partners', 'HIV-positive women were invited for in-depth interviews to share their experiences in offering HIVST to their partners and how self-testing impacted their relationships', 'Two hundred ninety-seven women were randomized to HIVST, 12 of whom self-reported being HIV positive and 11 participated in the interview']",[],[],"[{'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",[],[],297.0,0.0372823,"Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. ","[{'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Gift-Noelle', 'Initials': 'GN', 'LastName': 'Wango', 'Affiliation': 'Nyanza Initiative for Girls Education and Empowerment, Kisumu, Kenya.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Obonyo', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of the International Association of Providers of AIDS Care,['10.1177/2325958220919230'] 14,32340927,Memantine Effects on Electroencephalographic Measures of Putative Excitatory/Inhibitory Balance in Schizophrenia.,"BACKGROUND Abnormalities in cortical excitation and inhibition (E/I) balance are thought to underlie sensory and information processing deficits in schizophrenia. Deficits in early auditory information processing mediate both neurocognitive and functional impairment and appear to be normalized by acute pharmacologic challenge with the NMDA antagonist memantine (MEM). METHODS Thirty-six subjects with a diagnosis of schizophrenia and 31 healthy control subjects underwent electroencephalographic recordings. Subjects ingested either placebo or MEM (10 or 20 mg) in a double-blind, within-subject, crossover, randomized design. The aperiodic, 1/f-like scaling property of the neural power spectra, which is thought to index relative E/I balance, was estimated using a robust linear regression algorithm. RESULTS Patients with schizophrenia had greater aperiodic components compared with healthy control subjects (p < .01, d = 0.64), which was normalized after 20 mg MEM. Analysis revealed a significant dose × diagnosis interaction (p < .0001, d = 0.82). Furthermore, the MEM effect (change in aperiodic component in MEM vs. placebo conditions) was associated with baseline attention and vigilance (r = .54, p < .05) and MEM-induced enhancements in gamma power (r = -.60, p < .01). CONCLUSIONS Findings confirmed E/I balance abnormalities in schizophrenia that were normalized with acute MEM administration and suggest that neurocognitive profiles may predict treatment response based on E/I sensitivity. These data provide proof-of-concept evidence for the utility of E/I balance indices as metrics of acute pharmacologic sensitivity for central nervous system therapeutics.",2020,"RESULTS Patients with schizophrenia had greater aperiodic components compared with healthy control subjects (p < .01, d = 0.64), which was normalized after 20 mg MEM.","['Thirty-six subjects with a diagnosis of schizophrenia and 31 healthy control subjects underwent', 'Schizophrenia']","['placebo or MEM', 'NMDA antagonist memantine (MEM', 'electroencephalographic recordings', 'Memantine']",['aperiodic components'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}]",36.0,0.172244,"RESULTS Patients with schizophrenia had greater aperiodic components compared with healthy control subjects (p < .01, d = 0.64), which was normalized after 20 mg MEM.","[{'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Voytek', 'Affiliation': 'Department of Cognitive Sciences, Halicioğlu Data Science Institute, and Neurosciences Graduate Program, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California; Department of Psychology, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California; VA Desert Pacific Mental Illness Research, Education and Clinical Center, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Savita G', 'Initials': 'SG', 'LastName': 'Bhakta', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Jo A', 'Initials': 'JA', 'LastName': 'Talledo', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California. Electronic address: nswerdlow@ucsd.edu.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, California; VA Desert Pacific Mental Illness Research, Education and Clinical Center, VA San Diego Healthcare System, San Diego, California.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.02.004'] 15,32347763,Dupilumab provides rapid and sustained improvement in SCORAD outcomes in adults with moderate-to-severe atopic dermatitis: combined results of four randomized phase 3 trials.,"Background: Dupilumab, a first-in-class therapy targeting the two key cytokines involved in the persistent underlying inflammatory pathway in atopic dermatitis (AD), is approved for treatment of moderate-to-severe AD in Europe, USA, Japan and several other countries. Objective: To assess dupilumab effects on SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD) over time in adults with moderate-to-severe AD. Methods: This post hoc analysis included 2,444 patients in four placebo-controlled, double-blind, randomized, phase 3 trials. SOLO 1 and 2 (NCT02277743; NCT02277769) evaluated 16 weeks of dupilumab monotherapy against placebo. CAFÉ (NCT02755649) and CHRONOS (NCT02260986) evaluated dupilumab with concomitant topical corticosteroids (TCS) against TCS alone for 16 and 52 weeks, respectively. Results: 2,444 patients randomized to treatment in SOLO 1 and 2 ( N  = 1,379), CAFÉ ( N  = 325) and CHRONOS ( N  = 740) were analyzed. Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < .0001). These results occurred irrespective of dupilumab regimen, 300 mg subcutaneously weekly or every 2 weeks. Conclusions: In four large phase 3 trials in adults with moderate-to-severe AD, dupilumab treatment with or without concomitant TCS resulted in rapid and sustained improvements in all SCORAD outcomes vs. placebo or TCS alone.",2020,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","['2,444 patients randomized to treatment in SOLO 1&2', '2,444 patients in four', 'atopic dermatitis (AD', 'adults with moderate-to-severe atopic dermatitis', 'adults with moderate-to-severe AD']","['dupilumab monotherapy against placebo', 'TCS', 'dupilumab with concomitant topical corticosteroids (TCS) against TCS', 'placebo']","['SCORAD outcomes', 'SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD', 'overall SCORAD and individual components']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",2444.0,0.352091,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Service de Dermatologie, Centre Hospitalier Universitaire de Nantes , Nantes , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University , Munich , Germany.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences , Washington , DC , USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deleuran', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pellacani', 'Affiliation': 'Department of Dermatology, University of Modena and Reggio Emilia , Modena , Italy.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Armario-Hita', 'Affiliation': 'Service of Dermatology, University Hospital of Puerto Real, University of Cádiz , Cádiz , Spain.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi , Chilly-Mazarin , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme , Cambridge , MA , USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1750550'] 16,32348281,A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial.,"BACKGROUND Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. TRIAL REGISTRATION ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.",2020,"Within each program, we observed improvement on the 6-minute walk test (+41 meters, P<.001, ES=.99 for GetActive; +50 meters, P<.001, ES=.85 for GetActive-Fitbit) and self-reported physical function (P=.001, ES=.62 for GetActive; P=.024, ES=.38 for GetActive-Fitbit).",['Patients with chronic pain were randomized to GetActive (N=41) or'],"['mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit', 'Mind-body physical activity program']","['6-minute walk test and step-count', 'physical function', '6-minute walk test', 'Emotional function, pain intensity, pain coping and mindfulness', 'physical (self-report, performance based and objective) and emotional function, pain outcomes and coping', 'Mean step count', 'acceptability, credibility, therapist adherence, adherence to home-practice, ActiGraph wear, and client satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.059947,"Within each program, we observed improvement on the 6-minute walk test (+41 meters, P<.001, ES=.99 for GetActive; +50 meters, P<.001, ES=.85 for GetActive-Fitbit) and self-reported physical function (P=.001, ES=.62 for GetActive; P=.024, ES=.38 for GetActive-Fitbit).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Kulich', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'James', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}]",JMIR formative research,['10.2196/18703'] 17,32348007,"A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment.","OBJECTIVE Helicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication. METHODS We conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). RESULTS Altogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established margin of noninferiority, at -10% (the lower bounds of the 95% CI were -7.66% and -9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies. CONCLUSION The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.",2020,"The rate of adverse events was lower for BA than TF therapy (18.5% vs 26.1%, P = 0.024).","['Subjects with previous treatment failures recruited from 5 centers', 'gastric ulcers and gastric adenocarcinoma', '658 subjects were consecutively enrolled in total']","['esomeprazole and bismuth plus either berberine and amoxicillin (BA group) or tetracycline and furazolidone (TF group', 'amoxicillin plus berberine vs tetracycline plus furazolidone', 'Amoxicillin plus Berberine vs Tetracycline plus Furazolidone']","['rate of adverse events', 'rates of symptom improvement, compliance and adverse events', 'rates of compliance and symptom improvement', 'H. pylori infection status', 'eradication rate', 'efficacy and safety']","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",658.0,0.115176,"The rate of adverse events was lower for BA than TF therapy (18.5% vs 26.1%, P = 0.024).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Wen Quan', 'Initials': 'WQ', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Si Ran', 'Initials': 'SR', 'LastName': 'Wu', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yong Xi', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Jin Ping', 'Initials': 'JP', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Jie Hong', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Dong Hong', 'Initials': 'DH', 'LastName': 'Yuan', 'Affiliation': ""Department of Gastroenterology, Yan'an University Affiliated Hospital, Yan'an, Shaanxi Province, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yong Quan', 'Initials': 'YQ', 'LastName': 'Shi', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}]",Journal of digestive diseases,['10.1111/1751-2980.12870'] 18,32278029,"Addition of Chinese herbal remedy, Tongguan Capsules, to the standard treatment in patients with myocardial infarction improve the ventricular reperfusion and remodeling: Proteomic analysis of possible signaling pathways.","ETHNOPHARMACOLOGICAL RELEVANCE Tongguan Capsules (TGC), a patented Chinese herbal remedy containing Salvia miltiorrhiza, Astragalus membranaceus, Borneolum syntheticum and Grasshopper, has been previously tested in the experimental model of animal hearts subjected to ischemia/reperfusion injury and its cardioprotective effect has been described. AIM OF THE STUDY This clinical trial was aimed at investigation whether the administration of TGC to patients suffered myocardial infarction (MI), would diminish dilation of the left ventricular (LV) and reduce development of the adverse clinical consequences. METHODS Eligible patients were enrolled and randomized 1:1 to TGC (4.5 g/d for 6 months) superimposed on standard treatment for MI, or the control group receiving the standard protocol alone. The outcomes of this trial were valued after 6 months and reported as a mean change from the baseline in LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia that required the additional therapy within 6 months. In addition, arrays with a panel of specific antibodies were used to assess levels of major cytokines and other pathophysiologic markers, that prompted conclusions about the mechanisms of the ultimate clinical outcomes in both patient's subgroups. RESULTS Meaningfully, obtained results indicated that MI patients randomly assigned to the TGC treatment, demonstrated a significant reduction of LVESVI (-4.03 ± 0.73 vs. 1.59 ± 0.43 mL/m 2 , P < 0.001) and a lower incidence of the major adverse cardiovascular events (5.45% vs. 11.44%, P = 0.033). Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis. CONCLUSION Addition of TGC to the current conventional treatment of MI patients, significantly reduced their adverse LV remodeling and contributed to the more positive clinical outcome. TRIAL REGISTRATION ChiCTR-IPR-17011618.",2020,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","['Eligible patients', 'patients with myocardial infarction', 'patients suffered myocardial infarction (MI']","['TGC', 'Chinese herbal remedy, Tongguan Capsules', 'standard treatment for MI, or the control group receiving the standard protocol alone']","['levels of markers of myocardial apoptosis and fibrosis', 'LVESVI', 'major adverse cardiovascular events', 'LV end-systolic volume index (LVESVI) and as a frequency of MI recurrence, target-vessel revascularization, severity of heart failure or significant arrhythmia', 'adverse LV remodeling', 'serum levels of major inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C2605709', 'cui_str': 'tongguan'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.109447,"Meaningfully, those patients consistently demonstrated lower serum levels of major inflammatory cytokines, as well as reduced levels of markers of myocardial apoptosis and fibrosis (adjusted ??","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.'}, {'ForeName': 'Yuanshen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Ruixiang', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Qubo', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Biological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Discipline of Integrated Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. Electronic address: minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, Toronto, M5G 0A4, Canada.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112794'] 19,32348286,A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.,"BACKGROUND Heavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested. OBJECTIVE This pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component. METHODS Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months. RESULTS Participants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ 2 1 =6.2; P=.01). CONCLUSIONS This is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work. TRIAL REGISTRATION ClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.",2020,"Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed.","['Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day', 'Heavy Drinkers', 'HD smokers']","['EX-S and EX-HD', 'Alcohol-focused smoking cessation interventions', 'automated digital smoking cessation program', 'Digital Smoking Cessation', 'EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",[],,0.0498056,"Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed.","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Costantino', 'Affiliation': 'Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Toll', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nichea S', 'Initials': 'NS', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, South Kingston, RI, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}]",JMIR formative research,['10.2196/formative.7570'] 20,32348291,A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study.,"BACKGROUND Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment. OBJECTIVE This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program. METHODS Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points. RESULTS This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021. CONCLUSIONS The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/18098.",2020,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","['July 2019, funded in August 2019, and will commence enrollment in April 2020', 'Severe obesity among the youth (BMI for age ≥120th percentile', '80 youths with obesity (aged 13-18 years) and caregiver dyads']","['established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT', 'animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based-upon a Web-based dashboard', 'Brenner FIT or Brenner mFIT']",['Physical Activity and Eating Behaviors'],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",80.0,0.0505492,"The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight-loss interventions, which highlights that a family-based treatment approach is warranted.","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Dilley', 'Affiliation': 'Department of Plastic Surgery, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Camelia R', 'Initials': 'CR', 'LastName': 'Singletary', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Vahé', 'Initials': 'V', 'LastName': 'Heboyan', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'De Leo', 'Affiliation': 'Department of Interdisciplinary Health Sciences, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education & Behavior, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McGrievy', 'Affiliation': 'Office of Operations and Accreditation, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics & Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}]",JMIR research protocols,['10.2196/18098'] 21,32352828,Beyond language: Impacts of shared reading on parenting stress and early parent-child relational health.,"This study examined the interrelated and longitudinal impacts of parent-child shared book reading, parenting stress, and early relational health, as measured by both parental warmth and parent sensitivity, from infancy to toddlerhood. To extend findings from previous studies of collateral effects that have been conducted in parenting interventions, we examined parenting behaviors in a broader context to determine whether shared book reading would confer collateral benefits to the parent and parent-child relationship beyond those expected (i.e., language and literacy). It was hypothesized that positive parent-child interactions, such as shared reading, would have positive impacts on parent outcomes such as parenting stress, parental warmth, and sensitivity. The sample consisted of 293 low-income mothers and their children who participated in a randomized controlled trial. Shared book reading, parenting stress, and parental warmth were assessed when children were 6 and 18 months old. We computed a series of cross-lagged structural equation models to examine longitudinal interrelations among these three factors. Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status. These findings suggest that early parent-child book reading can have positive collateral impacts on parents' stress and the parent-child relationship over time. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.",['293 low-income mothers and their children who participated in a randomized controlled trial'],[],"['Shared book reading, parenting stress, and parental warmth', 'parental warmth and observed sensitivity', 'parenting stress', 'parenting stress and early parent-child relational health']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0423104,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.","[{'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Canfield', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Miller', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics.'}]",Developmental psychology,['10.1037/dev0000940'] 22,32353816,Effects of a Mindfulness-based Intervention on diurnal cortisol pattern in disadvantaged families: A randomized controlled trial.,"OBJECTIVE The present study examined the psychophysiological effects of Family-based Mindfulness Intervention (FBMI) on children and parents from disadvantaged families. METHODS This randomized controlled trial recruited parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n = 26) and waitlist control (n = 25) groups. The parent intervention included 6 sessions and the child intervention included 8 sessions with 2 half-hour joint programs. Both interventions lasted 9 hours in total each. All participants completed four salivary cortisol measures after wakeup, before lunchtime, late-afternoon, and before sleep at baseline and end of the intervention. The diurnal cortisol pattern was summarized by the morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope. RESULTS Compared to the control group, children in the FBMI group showed significant increases in morning cortisol (d = 0.50, p =  0.03) and significant decreases in diurnal cortisol slopes (d = 0.50, p =  0.04) at the end of intervention. Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention. No significant treatment effects were found on the mean cortisol. DISCUSSION The present findings suggest that FBMI could improve the diurnal cortisol slope and cortisol levels of the children and parents from disadvantaged families, respectively. Future studies should elucidate its potential benefits on neuroendocrine functioning.",2020,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","['children and parents from disadvantaged families', 'parents and their children from 51 disadvantaged families in Hong Kong and randomized them into FBMI (n\u202f=\u202f26) and waitlist control (n\u202f=\u202f25) groups', 'disadvantaged families']","['Mindfulness-based Intervention', 'FBMI', 'Family-based Mindfulness Intervention (FBMI', 'child intervention included 8 sessions with 2 half-hour joint programs']","['morning cortisol, evening cortisol, mean cortisol, and diurnal cortisol slope', 'diurnal cortisol slopes', 'morning cortisol', 'evening cortisol', 'diurnal cortisol slope and cortisol levels', 'salivary cortisol measures', 'mean cortisol', 'diurnal cortisol pattern']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",51.0,0.0257721,"Parents in the FBMI group displayed significant decreases in evening cortisol (d = 0.50, p =  0.04) compared to the control group at the end of intervention.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herman H M', 'Initials': 'HHM', 'LastName': 'Lo', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: herman.lo@polyu.edu.hk.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Hong Kong; Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104696'] 23,32348797,"Anticipation of 24 h severe energy restriction increases energy intake and reduces physical activity energy expenditure in the prior 24 h, in healthy males.","Intermittent fasting involves alternating between severely restricted and unrestricted energy intake. Physical activity energy expenditure (PAEE) is reduced during, and energy intake is elevated after, a period of energy restriction, but whether these are altered in anticipation of energy restriction is unknown. The aim of this study was to assess energy intake and PAEE in the 24 h before severe energy restriction. In randomised, counterbalanced order, 14 healthy males completed two 48 h trials over 3 days. On day 1, participants were informed which diet they would receive on day 2; either an energy balanced diet providing 100% (2755 (159) kcal; EB) or an energy restricted diet providing 25% (691 (42) kcal; ER), of their estimated energy requirements. Throughout day 1, ad-libitum energy intake was then determined from researcher-provided breakfast (08:30-09:00), lunch (12:30-13:00), afternoon snacks (14:00-18:00) and dinner (19:30-20:00). On day 2, participants consumed their allocated diet as instructed. On day 3, ad-libitum energy intake was assessed at breakfast (08:30-09:00). PAEE was measured throughout via integrated heart-rate and accelerometry monitors. Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB. PAEE was 156 (252) kcal lower on day 1 (P < 0.05) and 239 (391) lower on day 2 (P < 0.05) during ER compared to EB. These behavioural compensations meant that the energy deficit produced by 24 h severe energy restriction was attenuated by 1108 (415) kcal (46%) over the study period (P < 0.0001). These results suggest that compensatory changes in energy intake and PAEE occur before, during and after an acute 24 h period of severe energy restriction, likely lessening the energy deficit created.",2020,Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB.,"['14 healthy males completed two 48\u202fh trials over 3 days', 'healthy males', '24\u202fh before severe energy restriction']",['Physical activity energy expenditure (PAEE'],"['physical activity energy expenditure', 'Energy intake', 'severe energy restriction', 'PAEE', 'energy intake and PAEE']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",14.0,0.0312231,Energy intake was 6% greater on day 1 (260 (344) kcal; P < 0.05) and 14% greater at breakfast on day 3 (223 (59) kcal; P < 0.05) during ER compared to EB.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'James', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK. Electronic address: David.Clayton@ntu.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104719'] 24,32344176,Imagining a positive future reduces cortisol response to awakening and reactivity to acute stress.,"The positive influence of optimism on health is thought to be due in part to a reduced physiological response to stress, as manifested for instance in activity of hypothalamic-pituitary-adrenal (HPA) systems. Results of previous studies support the notion that dispositional optimism can influence diurnal cortisol secretion as well as cortisol reactivity. The aim of the present study was to examine whether induced optimism can similarly affect HPA activity and thereby potentially have beneficial health effects. We assigned 66 university students to either the Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises. Before and after the intervention, we assessed diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal. Effects of the BPS intervention were tested with repeated measures ANOVA (psychological outcomes) and multilevel regression (cortisol outcomes). The BPS intervention was associated with decreases in both the CAR and cortisol responses to acute stress. Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism. Within-person decreases in worrying were associated with decreased CARs, whereas both decreased worrying and increased PA were linked to attenuated stress reactivity. Results suggest that the BPS intervention can influence HPA axis reactivity, with effects on well-being variables likely mediating the process. More research is needed to determine longer-term neuroendocrine and health effects of such interventions in at-risk as well as healthy populations.",2020,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.",['66 university students to either the'],"['BPS intervention', 'Best Possible Self (BPS) or an active control condition, respectively entailing two weeks of daily visualization of a positive future or time management exercises']","['optimism', 'CAR and cortisol responses', 'cortisol response', 'diurnal cortisol levels, response to awakening (CAR), and reactivity to the Trier Social Stress Task (TSST), as well as optimism, affect, negative cognitions, perceived stress, and threat appraisal', 'HPA axis reactivity', 'HPA activity', 'diurnal cortisol secretion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",66.0,0.0181314,"Compared to controls, BPS participants showed decreased worrying and increased positive affect post-intervention; however, they did not show the expected greater increase in optimism.","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Nicolson', 'Affiliation': 'Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: n.nicolson@maastrichtuniversity.nl.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands. Electronic address: madelon.peters@maastrichtuniversity.nl.'}, {'ForeName': 'Yvo M C', 'Initials': 'YMC', 'LastName': 'In den Bosch-Meevissen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, 6229ER Maastricht, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104677'] 25,32353162,"Safety and pharmacokinetic profiles of MGS0274 besylate (TS-134), a novel metabotropic glutamate 2/3 receptor agonist prodrug, in healthy subjects.","AIMS The safety and pharmacokinetics of single and multiple doses of a novel mGlu 2/3 receptor agonist prodrug, MGS0274 besylate (TS-134), were investigated in healthy subjects. METHODS Phase 1 single-ascending dose (5-20 mg) and multiple-ascending dose titration (5-80 mg) studies were conducted in healthy male and female subjects. Both studies were randomized, double-blinded and placebo-controlled. In one cohort of single-ascending dose study (10 mg), concentrations of MGS0008, the active compound, in the cerebrospinal fluid (CSF) were measured for up to 24 hours postdose. RESULTS Following single and multiple oral administrations, MGS0274 was rapidly absorbed and extensively converted into MGS0008, which reached a maximum concentration (C max ) in plasma within 4 hours postdose and declined with a terminal half-life (t 1/2 ) of around 10 hours. Plasma exposure to MGS0274 was minimal, accounting for approximately 3% of the area under the concentration-time curve (AUC) of MGS0008. Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg). MGS0008 penetrated into CSF, with a CSF-to-plasma C max ratio of 3.66%, and was eliminated with a t 1/2 of approximately 16 hours. The most frequent treatment-emergent adverse events observed following single and multiple oral administration included headache, nausea, somnolence, dizziness and vomiting. CONCLUSION TS-134 is orally bioavailable in humans and converts rapidly and extensively to MGS0008, which exhibits good CSF penetration. Orally administered TS-134 was safe and generally well-tolerated; hence, TS-134 is a promising candidate for further clinical development for the treatment of disorders in which glutamatergic abnormalities are involved, such as schizophrenia.",2020,Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"['healthy male and female subjects', 'healthy subjects', 'Healthy Subjects']","['TS-134', 'novel mGlu 2/3 receptor agonist prodrug, MGS0274 besylate (TS-134', 'MGS0274 Besylate (TS-134', 'single-ascending dose (SAD; 5-20 mg) and multiple-ascending dose titration (MAD', 'placebo']","['Plasma C max and AUC of MGS0008', 'maximum concentration (C max ) in plasma', 'headache, nausea, somnolence, dizziness and vomiting']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0963196', 'cui_str': 'MGS 0008'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0852044,Plasma C max and AUC of MGS0008 at steady state increased dose proportionally (5-80 mg).,"[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marcy', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., NJ, USA.'}, {'ForeName': 'Kohnosuke', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hikichi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Okuyama', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hakop', 'Initials': 'H', 'LastName': 'Gevorkyan', 'Affiliation': 'California Clinical Trials Medical Group, CA, USA.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",British journal of clinical pharmacology,['10.1111/bcp.14331'] 26,32356115,Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis.,"In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA.",2020,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","['424 patients', 'psoriatic arthritis', 'patients with psoriatic arthritis (PsA']","['subcutaneous abatacept 125\xa0mg weekly or placebo', 'placebo']","['ACR20 response', 'elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and\u2009≥\u20093 joint erosions', 'Odds ratios (ORs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",424.0,0.122464,"In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA. pmease@philipmease.com.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'FitzGerald', 'Affiliation': ""St. Vincent's University Hospital, The Conway Institute for Biomolecular Research, and University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Yedid', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Excelya, Boulogne-Billancourt, France.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}]",Rheumatology international,['10.1007/s00296-020-04564-x'] 27,32350413,Scheduling nab-paclitaxel combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma.,"BACKGROUND Nab-paclitaxel plus gemcitabine (nabP+gemcitabine) offers modest survival gains for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Sequential scheduling of nabP+gemcitabine in a PDAC mouse model improved efficacy; this hypothesis was tested in a clinical trial. METHODS Patients with previously untreated metastatic PDAC were randomised to receive nabP+gemcitabine administered either concomitantly on the same day, or sequentially, with gemcitabine administered 24 h after nabP. The primary outcome measure was progression-free survival (PFS). Secondary outcome measures were objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers. RESULTS In total, 71 patients received sequential (SEQ) and 75 concomitant (CON) treatment. Six-month PFS was 46% with SEQ and 32% with CON scheduling. Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33, p = 0.70). CTCAE Grade ≥3 neutropaenia incidence doubled with SEQ therapy but was not detrimental to QoL. Strongly positive tumour epithelial cytidine deaminase (CDA) expression favoured benefit from SEQ therapy (PFS HR 0.31, 95% CI 0.13-0.70). CONCLUSIONS SEQ delivery of nabP+gemcitabine improved PFS and ORR, with manageable toxicity, but did not significantly improve OS. CLINICAL TRIAL REGISTRATION ISRCTN71070888; ClinialTrials.gov (NCT03529175).",2020,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","['Patients with previously untreated metastatic PDAC', 'metastatic pancreatic adenocarcinoma', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC']","['nabP+gemcitabine', 'sequential (SEQ) and 75 concomitant (CON) treatment', 'Scheduling nab-paclitaxel combined with gemcitabine', 'paclitaxel plus gemcitabine (nabP+gemcitabine', 'gemcitabine']","['Median PFS', 'OS', 'CTCAE Grade ≥3 neutropaenia incidence', 'objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers', 'survival gains', 'ORR', 'SEQ arm; median OS', 'efficacy', 'PFS and ORR, with manageable toxicity', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.254728,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK. pippa.corrie@addenbrookes.nhs.uk.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lwuji', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scott-Brown', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'The Royal Free Hospital, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gopinathan', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Skells', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bundi', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brais', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dalchau', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bax', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Machin', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dayim', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals, Truro, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospitals, Leeds, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Isherwood', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neesse', 'Affiliation': 'Gastroenterology and Gastrointestinal Cancer Clinic, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tuveson', 'Affiliation': 'Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Jodrell', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}]",British journal of cancer,['10.1038/s41416-020-0846-2'] 28,32349513,"Immediate Effects of Self-Thai Foot Massage on Skin Blood Flow, Skin Temperature, and Range of Motion of the Foot and Ankle in Type 2 Diabetic Patients.","Objectives: The purpose of this study was to investigate the immediate effects of self-Thai foot massages (STFMs) on the foot skin blood flow, the foot skin temperature, and range of motion (ROM) of the foot and ankle in type 2 diabetic patients with peripheral neuropathy. Design: A randomized crossover study. Subjects: Twenty five diabetic patients with peripheral neuropathy were recruited. Interventions: Participants were randomly assigned to either STFM or Thai foot massage (TFM) performed by a massage therapist; then, they were switched to the other group after a 1-week washout period. In both groups, the foot massage was performed in a seated position on the dominant lower leg and foot for 25 min. Outcome measures: Before and immediately after treatment, foot skin blood flow, foot skin temperature, and ROM of the foot and ankle were evaluated. Heart rate was measured throughout the treatment. Results: After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05). Foot skin temperature did not change in STFM, whereas it significantly increased in TFM. Heart rate significantly increased in STFM, whereas it tended to decrease in TFM. Conclusions: Both STFM and TFM by a massage therapist could improve foot skin blood flow and ROM of the foot and ankle in diabetic patients with peripheral neuropathy. An STFM could be a promising alternative treatment that patients can perform at home.",2020,"After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05).","['Subjects: Twenty five diabetic patients with peripheral neuropathy were recruited', 'Type 2 Diabetic Patients', 'type 2 diabetic patients with peripheral neuropathy', 'diabetic patients with peripheral neuropathy']","['self-Thai foot massages (STFMs', 'STFM', 'STFM or Thai foot massage (TFM) performed by a massage therapist', 'Self-Thai Foot Massage', 'STFM and TFM']","['Skin Blood Flow, Skin Temperature, and Range of Motion of the Foot and Ankle', 'TFM', 'Heart rate', 'Outcome measures: Before and immediately after treatment, foot skin blood flow, foot skin temperature, and ROM of the foot and ankle', 'foot skin blood flow, the foot skin temperature, and range of motion (ROM', 'foot skin blood flow and ROM', 'Foot skin temperature', 'foot skin blood flow and ROM of the foot and ankle']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}]",25.0,0.0167828,"After a single treatment of the massage, foot skin blood flow and ROM of the foot and ankle significantly improved in both groups ( p  < 0.05).","[{'ForeName': 'Uraiwan', 'Initials': 'U', 'LastName': 'Chatchawan', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kawita', 'Initials': 'K', 'LastName': 'Jarasrungsichol', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Yamauchi', 'Affiliation': 'Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University, Khon Kaen, Thailand.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0328'] 29,32353218,"Effect of a combined exercise program on physical fitness, lung function, and quality of life in patients with controlled asthma and exercise symptoms: A randomized controlled trial.","BACKGROUND Asthmatic patients may benefit from exercise training, although the effects of a combined aerobic and resistance training program are still poorly investigated in children and adolescents. OBJECTIVE To analyze the effects of a combined exercise training (resistance and aerobic) program on aerobic fitness, lung function, asthma control and quality of life in a group of mild-moderate asthmatic children with exercise symptoms. METHODS This was a 12-week randomized controlled trial including children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms. The intervention group (IG) performed the exercise training (resistance and aerobic) 3 days/week, for 60 minutes. The control group (CG) followed routine clinical orientations. The main outcomes were cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests after 3 months of the intervention. RESULTS Fifty-three patients (IG = 25 and CG = 28) with a mean age of 11.5 ± 2.6 years were included. No significant differences were found between groups regarding lung function, asthma control, quality of life, and functional tests. Ventilatory equivalent for oxygen consumption at ventilatory threshold (P = .025; η p 2  = 0.083), peak oxygen consumption (P = .008; η p 2  = 0.116) and test duration (P = .014; η p 2  = 0.1) presented greater improvements in the IG. In addition, improvements were observed in leg press (P < .001; η p 2  = 0.36), hamstring curl (P = .001; η p 2  = 0.217), high row (P = .003; η p 2  = .167), low row (P = .009; η p 2  = 0.128) and quadriceps leg extension (P = .015; η p 2  = 0.108) in the IG. CONCLUSION Combined exercise training (resistance and aerobic) improved cardiorespiratory fitness and muscle strength in children and adolescents with controlled asthma and exercise symptoms.",2020,"In addition, improvements were observed in leg press (P < .001; η p 2  = 0.36), hamstring curl (P = .001; η p 2  = 0.217), high row (P = .003; η p 2  = .167), low row (P = .009; ","['children and adolescents diagnosed with mild-moderate asthma and presenting exercise-induced symptoms', 'Fifty-three patients (IG\u2009=\u200925 and CG\u2009=\u200928) with a mean age of 11.5\u2009±\u20092.6 years were included', 'patients with controlled asthma and exercise symptoms', 'mild-moderate asthmatic children with exercise symptoms', 'Asthmatic patients', 'children and adolescents with controlled asthma and exercise symptoms', 'children and adolescents']","['exercise training', 'combined aerobic and resistance training program', 'exercise training (resistance and aerobic', 'combined exercise training (resistance and aerobic) program', 'Combined exercise training (resistance and aerobic', 'combined exercise program']","['leg press', 'quadriceps leg extension', 'cardiorespiratory fitness, muscle strength, lung function, quality of life, asthma control, and functional tests', 'hamstring curl', 'lung function, asthma control, quality of life, and functional tests', 'peak oxygen consumption', 'physical fitness, lung function, and quality of life', 'aerobic fitness, lung function, asthma control and quality of life', 'cardiorespiratory fitness and muscle strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0378759,"In addition, improvements were observed in leg press (P < .001; η p 2  = 0.36), hamstring curl (P = .001; η p 2  = 0.217), high row (P = .003; η p 2  = .167), low row (P = .009; ","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Sanz-Santiago', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Diez-Vega', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santana-Sosa', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lopez Nuevo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Iturriaga Ramirez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Vendrusculo', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Márcio Vinícius Fagundes', 'Initials': 'MVF', 'LastName': 'Donadio', 'Affiliation': 'Laboratory of Pediatric Physical Activity, Infant Center, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Villa Asensi', 'Affiliation': 'Pulmonology Unit, Hospital Universitario Infantil Niño Jesús de Madrid, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Pérez-Ruiz', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.'}]",Pediatric pulmonology,['10.1002/ppul.24798'] 30,32353635,Feasibility of decision rule-based treatment of comorbid youth: A pilot randomized control trial.,"This study examined the feasibility, acceptability, and preliminary efficacy of a decision rule driven treatment for youth with comorbid conduct problems and depression. A randomized, controlled, repeated measures design was used to compare two treatment approaches: Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ). Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder). Assessments were conducted at baseline, post-treatment, and six-month follow-up. Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions. Both treatments showed similar remission of internalizing and externalizing diagnoses. Participants in DR showed significantly greater improvements at six-month follow-up in child-reported depressive symptom severity compared to SEQ. Both DR and SEQ conditions showed significantly lower behavior problems at end of treatment and six-month follow-up. DR showed significant reductions in emotion dysregulation at 6-month follow-up, while SEQ did not. Findings suggest that a decision rule based intervention holds promise as a feasible and acceptable treatment with high rates of remittance.",2020,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","['Participants included 30 children (ages 8-14; 66% female; 80% Caucasian) who met criteria for a depressive disorder (major depressive disorder and/or dysthymia) and a conduct problem disorder (oppositional defiant disorder and/or conduct disorder', 'youth with comorbid conduct problems and depression', 'comorbid youth']",['Decision-Rule Based Treatment (DR) and Sequential Treatment (SEQ'],"['remission of internalizing and externalizing diagnoses', 'behavior problems', 'depressive symptom severity', 'emotion dysregulation']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0149654', 'cui_str': 'Conduct disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0310239,"Treatment adherence, attendance, and session evaluations ratings indicate that the treatments were feasible to implement and acceptable to parents and youth in both conditions.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Wolff', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA. Electronic address: jennifer_wolff@brown.edu.'}, {'ForeName': 'Abbe', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA; Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Lourah M', 'Initials': 'LM', 'LastName': 'Kelly', 'Affiliation': 'Rhode Island Hospital, Providence, RI, USA; University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Frazier', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103625'] 31,32289380,Clinical outcomes in men of diverse ethnic backgrounds with metastatic castration-resistant prostate cancer.,"BACKGROUND We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration-resistant prostate cancer (mCRPC) treated with a docetaxel and prednisone (DP)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in prostate-specific antigen (PSA) from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen. PATIENTS AND METHODS Individual patient data from 8820 mCRPC men randomized on nine phase III trials to a DP-containing regimen were combined. Race used in the analysis was based on self-report. End points were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors. RESULTS Of 8820 patients, 7528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were 8.3 [95% confidence interval (CI) 8.2-8.5], 8.2 (95% CI 7.4-8.8) and 8.3 (95% CI 7.6-8.8) months in white, black and Asian men, respectively. Median PSA PFS were 9.9 (95% CI 9.7-10.4), 8.5 (95% CI 8.0-10.3) and 11.1 (95% CI 9.9-12.5) months in white, black and Asian men, respectively. CONCLUSIONS We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.",2020,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively. ","['white, black and Asian men with mCRPC treated with a DP-based regimen', 'men with mCRPC enrolled on these phase III clinical trials with DP', 'black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a', 'Men of Diverse Ethnic s with Metastatic Castration Resistant Prostate Cancer', 'Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified', 'Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined']",['docetaxel (D) and prednisone (P)-based regimen'],"['Median PSA PFS', 'Median PFS', 'progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",8820.0,0.269513,"Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively. ","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Duke University Medical Center and Duke University, Durham, USA. Electronic address: susan.halabi@duke.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Old Dominion University, Norfolk, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': 'The Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, New Haven, USA.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus San Rosa Hospital Medical Center, San Antonio, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency - Vancouver Centre, Vancouver, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'University of Washington and Fred Hutchinson Cancer Research Center, Seattle, USA.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.309'] 32,32356244,Ranibizumab Pretreatment in Vitrectomy with Internal Limiting Membrane Peeling on Diabetic Macular Edema in Severe Proliferative Diabetic Retinopathy.,"AIM To evaluate the efficacy of intravitreal ranibizumab (IVR) pretreatment for pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling in severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME). METHODS Sixty-three patients with ME and PDR were divided into IVR and control groups. Three days before PPV stripping, ranibizumab was injected into the patients in the IVR group. The patients were followed for 6 months. The best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications were compared between the two groups. RESULTS The BCVA of the IVR group was significantly improved at 1, 3 and 6 months compared with the preoperative BCVA (P < 0.01). The BCVA of the control group was significantly improved at 3 and 6 months compared with the preoperative BCVA (P < 0.01), but was not significantly improved at 1 month. At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months. The CMT of the IVR group was thinner than that of the control group at 1 and 3 months (P < 0.01), with no significant difference at 6 months after surgery. The surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade were significantly different between the two groups (all P < 0.05). There was no significant difference between the two groups in terms of postoperative complications. CONCLUSIONS Ranibizumab pretreatment may improve the outcome of PPV with ILM peeling for severe PDR with ME by decreasing ME and intraoperative complications.",2020,"At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months.","['severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME', 'Sixty-three patients with ME and PDR', 'Severe Proliferative Diabetic Retinopathy']","['Vitrectomy with Internal Limiting Membrane Peeling', 'pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling', 'Ranibizumab', 'intravitreal ranibizumab (IVR', 'PPV stripping, ranibizumab']","['Diabetic Macular Edema', 'best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications', 'surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade', 'postoperative complications', 'BCVA']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035321', 'cui_str': 'Retinal tear'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",63.0,0.0259205,"At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Cai', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Liu', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Ning-Ning', 'Initials': 'NN', 'LastName': 'Liu', 'Affiliation': 'The Department of Ophthalmology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China. ningning1688@126.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00822-0'] 33,32356365,Super high-flux hemodialysis provides comparable effectiveness with high-volume postdilution online hemodiafiltration in removing protein-bound and middle-molecule uremic toxins: A prospective cross-over randomized controlled trial.,"Although high-volume postdilution online hemodiafiltration (ol-HDF) is superior to high-flux HD in removing all kinds of uremic toxins and improving survival, this treatment is not available in most HD centers. The present study was conducted to compare the effectiveness in removals of protein-bound (indoxyl sulfate [IS]), middle-molecule [beta-2 microglobulin (B2M) and alpha-1 microglobulin (A1MG)], and small-molecule uremic toxins between super high-flux HD (SHF-HD), HD with a novel SHF dialyzer and high-volume postdilution ol-HDF in a noninferiority fashion. Fifteen prevalent HD patients were randomly allocated into two sequences of 12-week treatment periods of SHF-HD treatment and later high-volume postdilution ol-HDF period or vice versa. Each treatment period was divided by a wash-out phase of 4-week high-flux HD. Twelve of 15 patients could complete the study. When compared with high-volume postdilution ol-HDF (convective volume of 24.4 ± 3.52 L), SHF-HD provided comparable reduction ratio values of IS, B2M, and A1MG with mean difference of 5.87 (95% confidence interval [CI] -1.63, 13.37), 1.98 (95% CI,-0.21, 4.18), and 22.96 (95% CI, -1.91, 47.83), respectively. The spKt/Vurea was not different. The predialysis levels of all uremic toxins at baseline and after 12-week treatment did not differ between both groups. Although albumin loss in dialysate in SHF-HD was greater than high-volume postdilution ol-HDF, the serum albumin levels after 12-week SHF-HD treatment were significantly higher than baseline. In conclusion, SHF-HD provides noninferior effectiveness to high-volume postdilution ol-HDF in removing various uremic toxins with significantly increased serum albumin levels despite higher albumin loss. SHF-HD might be an effectively alternative treatment when high-volume postdilution ol-HDF is not available.",2020,The pre-dialysis levels of all uremic toxins at baseline and after 12-week treatment did not differ between both groups.,"['Fifteen prevalent HD patients', 'Middle-molecule Uremic Toxins']","['protein-bound (indoxyl sulfate, IS), middle-molecule [beta-2 microglobulin (B2M) and alpha-1 microglobulin (A1MG', 'SHF-HD treatment and later high-volume post-dilution ol-HDF period or vice versa', 'High-Volume Post-dilution Online Hemodiafiltration']","['pre-dialysis levels of all uremic toxins', 'serum albumin levels']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}]","[{'cui': 'C0033618', 'cui_str': 'Protein binding'}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0051266', 'cui_str': 'Alpha 1 microglobulin'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445431', 'cui_str': 'After the filter'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",15.0,0.0143314,The pre-dialysis levels of all uremic toxins at baseline and after 12-week treatment did not differ between both groups.,"[{'ForeName': 'Theerachai', 'Initials': 'T', 'LastName': 'Thammathiwat', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Khajohn', 'Initials': 'K', 'LastName': 'Tiranathanagul', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Maneerut', 'Initials': 'M', 'LastName': 'Limjariyakul', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Chariyavilaskul', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kullaya', 'Initials': 'K', 'LastName': 'Takkavatakarn', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Paweena', 'Initials': 'P', 'LastName': 'Susantitaphong', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Srichan', 'Initials': 'S', 'LastName': 'Meesangnin', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supeecha', 'Initials': 'S', 'LastName': 'Wittayalertpanya', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kearkiat', 'Initials': 'K', 'LastName': 'Praditpornsilpa', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Eiam-Ong', 'Affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13508'] 34,32297590,Rigorous Randomized Controlled Trial Implementation in the Era of COVID-19.,,2020,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,[],[],[],[],[],[],,0.195176,Rigorous Randomized Controlled Trial Implementation in the Era of Novel Coronavirus Disease (COVID-19).,"[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0262'] 35,32293959,Re: Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-Up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,,2020,,['Clinically Localized Prostate Cancer'],['Re: Radical Prostatectomy or Observation'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.0173406,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056.01'] 36,32293960,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056'] 37,32378654,A Comparison of the Weight Loss Effect between a Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy.,"Objective Intragastric balloon (IGB) therapy is a low-invasion treatment for obesity. Recently, a low-carbohydrate diet has shown effectiveness for encouraging weight loss, but whether or not a low-carbohydrate diet improves the efficacy of IGB therapy remains unclear. Therefore, we examined the effectiveness of a low-carbohydrate diet compared with a calorie-restricted diet in combination with IGB therapy. Methods A prospective study was conducted on 51 patients who had undergone IGB therapy from October 2012 to December 2017. Overall, 31 of the 51 patients were included in this study (12-month assessment after IGB placement). These 31 cases consisted of 18 IGB plus low-carbohydrate diet and 13 IGB plus calorie-restricted diet. We compared the two groups with respect to body weight loss as outcomes. Results At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005). The percentage of excess weight loss in the IGB plus low-carbohydrate diet group was slightly higher than that in the IGB plus calorie-restricted diet group, but there was no significant difference between the 2 groups at 12 months after IGB placement (IGB plus low-carbohydrate 49.9±60.0%, IGB plus calorie-restricted diet 33.1±27.0%). Conclusion Our study demonstrated that both a low-carbohydrate diet and a calorie-restricted diet were effective interventions for weight reduction in combination with IGB therapy.",2020,"At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005).",['51 patients who had undergone IGB therapy from October 2012 to December 2017'],"['Objective Intragastric balloon (IGB) therapy', 'low-carbohydrate diet', 'IGB plus low-carbohydrate diet and 13 IGB plus calorie-restricted diet', 'Low-carbohydrate Diet and a Calorie-restricted Diet in Combination with Intragastric Balloon Therapy', 'calorie-restricted diet in combination with IGB therapy']","['body weight', 'percentage of excess weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",51.0,0.0136192,"At 12 months after IGB placement, the body weight was significantly lower than that observed at baseline in both the IGB plus low-carbohydrate diet group (baseline 101.9±25.8 kg, 12 months 88.2±21.9 kg) (p<0.0001) and the IGB plus calorie-restricted diet group (baseline 103.5±17.0 kg, 12 months 89.1±6.2 kg) (p<0.005).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Maekawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Niizawa', 'Affiliation': 'Nagano Matsushiro General Hospital, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.4153-19'] 38,32368935,A Randomized Controlled Trial of Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis: 19-Year Clinical and Radiological Follow-up.,"BACKGROUND Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB) is a reliable surgical option for the control of anterior knee laxity after ACL injury. The addition of a lateral extra-articular tenodesis (LET) may improve control of rotation knee laxity and improve short-term graft survival in high-risk patients. PURPOSE The aims of this study were to compare long-term patient-reported outcomes, graft survival, and risk of osteoarthritis between ACLR with and without LET. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS This study included 121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999. In total, 61 knees were randomized to an isolated BTB ACLR, and 60 knees were randomized to a BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire). RESULTS Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2). Of those patients, 43 had a clinical examination and completed patient-reported outcome questionnaires, and the other 37 patients were evaluated through the questionnaires alone. Standard radiographs were available for 45 patients and laximetry (TELOS) for 42 patients. Mean subjective International Knee Documentation Committee score at last follow-up was 81.8, and no differences were noted between the BTB and BTB-LET groups ( P = .7). Two-thirds of patients were still participating in pivoting sports. A total of 17 knees (21%) experienced a graft failure, 5 of which (6%) underwent revision ACLR. There was no significant difference in graft failure risk between the BTB group (29%) and the BTB-LET group (13%; P = .1). Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02). Lateral compartment osteoarthritis was correlated with partial lateral meniscectomy. CONCLUSION There were no significant differences in long-term patient-reported outcomes after ACLR with or without an LET. LET may increase the risk of lateral compartment osteoarthritis at long-term follow-up. There was a trend toward decreased graft failure risk with the addition of LET but this study was underpowered to assess this outcome.",2020,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02).,"['61 knees were randomized to an isolated BTB ACLR, and 60 knees', 'high-risk patients', '45 patients and laximetry (TELOS) for 42 patients', '121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999', 'Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2']","['Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis', 'LET', 'BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire', 'Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB', 'lateral extra-articular tenodesis (LET']","['graft failure risk', 'Mean subjective International Knee Documentation Committee score', 'Lateral compartment osteoarthritis', 'graft survival, and risk of osteoarthritis', 'risk of lateral compartment osteoarthritis', 'Lateral tibiofemoral osteoarthritis', 'rotation knee laxity and improve short-term graft survival', 'graft failure']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517642', 'cui_str': '20.2'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0185441', 'cui_str': 'Fixation of tendon'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0448621', 'cui_str': 'Tendon of gracilis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",61.0,0.143888,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%; P = .02).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Castoldi', 'Affiliation': 'Institut Universitaire Locomoteur et du Sport, Department of Orthopaedic Surgery, Centre Hospitalo-Universitaire de Nice, Nice, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Magnussen', 'Affiliation': 'Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Gunst', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Batailler', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Neyret', 'Affiliation': 'Infirmerie Protestante, Caluire, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Lustig', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Servien', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}]",The American journal of sports medicine,['10.1177/0363546520914936'] 39,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users. METHODS ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms. RESULTS We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups. CONCLUSIONS A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434'] 40,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268'] 41,32365251,Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY).,"BACKGROUND Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study. OBJECTIVE To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY. METHODS Analysis of 52-week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label. RESULTS At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < 0.0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms. CONCLUSIONS This second head-to-head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials. Clinicaltrials.gov identifier: NCT02826603.",2020,"At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥90% improvement in Psoriasis Area and Severity Index (73.2% vs 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < .0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < .0001), and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs 61.2%; P = .0028).",['patients with moderate to severe plaque psoriasis'],"['Secukinumab', 'secukinumab', 'secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label', 'secukinumab vs ustekinumab']","['quality of life', 'skin clearance and quality of life', 'Psoriasis Area and Severity Index', 'Dermatology Life Quality Index response', 'efficacy and safety', ""Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]",,0.300332,"At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved ≥90% improvement in Psoriasis Area and Severity Index (73.2% vs 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < .0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < .0001), and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs 61.2%; P = .0028).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nia', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hashim', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Vera', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': 'Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Paguet', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Beijing Novartis Pharma Co, Ltd, Shanghai, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16558'] 42,32366163,Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial.,"Background Trimethylamine N-oxide (TMAO) may have prothrombotic properties. We examined the association of TMAO quartiles with major adverse cardiovascular events (MACE) and the effect of TMAO on the efficacy of ticagrelor. Methods and Results PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin - Thrombolysis in Myocardial Infarction 54) randomized patients with prior myocardial infarction to ticagrelor or placebo (median follow-up 33 months). Baseline plasma concentrations of TMAO were measured in a nested case-control study of 597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR]. Odds ratios (OR) were used for the association between TMAO quartiles and MACE, adjusting for baseline clinical characteristics (age, sex, eGFR, region, body mass index, hypertension, hypercholesterolemia, diabetes mellitus, smoking, peripheral artery disease, index event, aspirin dosage and treatment arm), and cardiovascular biomarkers (hs-TnT [high-sensitivity troponin T], hs-CRP [high-sensitivity C-reactive protein], NT-proBNP [N-terminal-pro-B-type natriuretic peptide]). Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93, P trend=0.015). The association was driven by cardiovascular death (OR 2.25, 95% CI, 1.28-3.96, P trend=0.003) and stroke (OR 2.68, 95% CI, 1.39-5.17, P trend<0.001). After adjustment for clinical factors, the association persisted for cardiovascular death (OR adj 1.89, 95% CI, 1.03-3.45, P trend=0.027) and stroke (OR adj 2.01, 95% CI, 1.01-4.01, P trend=0.022), but was slightly attenuated after adjustment for cardiovascular biomarkers (cardiovascular death: OR adj 1.74, 95% CI, 0.88-3.45, P trend=0.079; and stroke: OR adj 1.82, 95% CI, 0.88-3.78, P trend=0.056). The reduction in MACE with ticagrelor was consistent across TMAO quartiles ( P interaction=0.92). Conclusions Among patients with prior myocardial infarction, higher TMAO levels were associated with cardiovascular death and stroke but not with recurrent myocardial infarction. The efficacy of ticagrelor was consistent regardless of TMAO levels. Registration URL: https://www.clini​caltr​ials.gov; Unique identifiers: PEGASUS-TIMI 54, NCT01225562.",2020,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93, P trend=0.015).","['Myocardial Infarction 54) randomized patients with prior myocardial infarction to', 'Patients With Prior Heart Attack Using', 'Patients', 'patients with prior myocardial infarction', 'With Prior Myocardial Infarction', '597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR']","['Ticagrelor', 'Placebo', ' Trimethylamine N-oxide (TMAO', 'ticagrelor or placebo', 'TMAO', 'Aspirin - Thrombolysis', 'ticagrelor']","['Baseline plasma concentrations of TMAO', 'cardiovascular death and stroke', 'Odds ratios (OR', 'cardiovascular death', 'Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes', 'stroke', 'TMAO levels', 'Higher TMAO quartiles', 'TMAO quartiles with major adverse cardiovascular events (MACE']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",597.0,0.189664,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93, P trend=0.015).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Xinmin S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research Division of Cardiovascular Medicine University of Colorado Denver CO.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center Rutgers-New Jersey Medical School Newark NJ.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat Paris France.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Cardiovascular Research Unit Department of Infection, Immunity and Cardiovascular Disease University of Sheffield United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Göteborg Sweden.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015331'] 43,32362436,Effects of incentives on viral suppression in people living with HIV who use cocaine or opiates.,"BACKGROUND Antiretroviral therapy (ART) adherence is essential to maintenance of undetectable viral loads among people living with HIV, which improves health and reduces HIV transmission. Despite these benefits, some people living with HIV do not maintain the level of adherence required to sustain an undetectable viral load. This problem is particularly common among people who use drugs. OBJECTIVE To determine effects of incentivizing viral suppression in people living with HIV who used cocaine or opiates. METHODS In this secondary analysis of data collected during a randomized controlled trial, participants (N=102) with detectable HIV viral loads (>200 copies/mL) were randomly assigned to a Usual Care or Incentive group. Usual Care participants did not earn incentives for viral suppression. Incentive participants earned incentives ($10/day maximum) for providing blood samples with reduced or undetectable (<200 copies/mL) viral loads. All participants completed assessments every three months. Results collected during the first year were compared based on group assignment and drug use. RESULTS Among participants who used cocaine or opiates, Incentive participants (n = 27) provided more (OR:4.0, CI:1.6-10.3, p = .004) blood samples with an undetectable viral load (69 %) than Usual Care participants (n = 25; 41 %). Among participants who did not use cocaine or opiates, Incentive participants (n = 25) provided more (OR:4.1, CI:1.5-10.7, p = .005) blood samples with an undetectable viral load (78 %) than Usual Care participants (n = 25; 36 %). Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992). CONCLUSIONS Incentivizing viral suppression can promote undetectable viral loads in people living with HIV who use cocaine or opiates.",2020,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992). ","['participants who did not use cocaine or opiates, Incentive participants (n = 25', 'people living with HIV who used cocaine or opiates', 'people who use drugs', 'people living with HIV who use cocaine or opiates', 'participants (N=102) with detectable HIV viral loads (>200 copies/mL', 'people living with HIV', 'participants who used cocaine or opiates, Incentive participants (n = 27']",['Usual Care or Incentive group'],['viral suppression'],"[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.168094,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992). ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pollock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: spolloc6@jhu.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ftoegel1@jhmi.edu.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rodewald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: arodewa1@jhmi.edu.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: jeannie-marie@jhu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Medicine, Comprehensive Care Practice, Johns Hopkins Bayview Medical Center, 5200 Eastern Ave # W2, Baltimore, MD 21224, USA. Electronic address: mifinger@jhmi.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ksilverm@jhmi.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108000'] 44,32360827,Axillary vein puncture guided by ultrasound vs cephalic vein dissection in pacemaker and defibrillator implant: A multicenter randomized clinical trial.,"BACKGROUND Axillary vein puncture guided by ultrasound (US-Ax) has emerged as a valid alternative access route to pacemaker and defibrillator lead insertion. OBJECTIVE The purpose of this study was to evaluate whether US-Ax compared to cephalic vein dissection (CV) improves success and early complications in pacemaker or defibrillator implant. METHODS This prospective, multicenter clinical trial included 88 adult patients randomized 1:1 to US-Ax (n = 44) or CV (n = 44). All procedures were performed by operators with no previous experience in axillary approach. Primary endpoint was defined as success rate. Secondary endpoints were venous access site change, time to obtain venous access, total procedural time, and early complication rate. Analyses were performed using the intention-to-treat principle. RESULTS Median age was 70.5 years (58.2-79.7), and 60.2% were male. For the primary outcome, a higher success rate was observed in the axillary group (97.7% vs 54.5%; P <.001), as well as a lower rate of venous access site change (2.3% vs 40.9%; P <.001) and shorter time to obtain venous access (5 vs 15 minutes; P <.001) and procedural time (40 vs 51 minutes; P = .010), with no difference in complication rate (2.3% vs 11.4%; P =.20). In multivariate analysis, US-Ax (P <.001), single-chamber device (P = .015), and body mass index (P = .015) were independent predictors of overall success. CONCLUSION This is the first randomized trial comparing self-learned US-Ax to CV in cardiac lead implantation. Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.",2020,"Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.","['Median age was 70.5 years (58.2-79.7), and 60.2% were males', '88 adult patients randomized 1:1 to US-Ax (n=44) or CV (n=44']","['Axillary vein puncture guided by ultrasound versus cephalic vein dissection', 'axillary vein puncture guided by ultrasound (US-Ax', 'cephalic vein dissection (CV']","['rate of venous access site change', 'success rate, time to obtain venous access and procedural time, with similar complication rate', 'body mass index', 'procedural time', 'venous access site change, time to obtain venous access, total procedural time, and early complication rate', 'higher success rate', 'complication rate', 'success rate', 'shorter time to obtain venous access']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",88.0,0.216018,"Our results indicate that the axillary approach was superior in terms of success rate, time to obtain venous access and procedural time, with similar complication rate.","[{'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Tagliari', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil. Electronic address: anapaulatagliari@yahoo.com.br.'}, {'ForeName': 'Adriano Nunes', 'Initials': 'AN', 'LastName': 'Kochi', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Mastella', 'Affiliation': 'Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Rodrigo Petersen', 'Initials': 'RP', 'LastName': 'Saadi', 'Affiliation': 'Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'di Leoni Ferrari', 'Affiliation': 'Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Keller', 'Initials': 'EK', 'LastName': 'Saadi', 'Affiliation': 'Cardiovascular Surgery Department, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil; Cardiovascular Surgery Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Carisi Anne', 'Initials': 'CA', 'LastName': 'Polanczyk', 'Affiliation': 'Postgraduate Program in Cardiology and Cardiovascular Sciences-School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Cardiology Department, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}]",Heart rhythm,['10.1016/j.hrthm.2020.04.030'] 45,30232416,Ghrelin is impacted by the endogenous circadian system and by circadian misalignment in humans.,"The human circadian system regulates hunger independently of behavioral factors, resulting in a trough in the biological morning and a peak in the biological evening. However, the role of the only known orexigenic hormone, ghrelin, in this circadian rhythm is unknown. Furthermore, although shift work is an obesity risk factor, the separate effects of the endogenous circadian system, the behavioral cycle, and circadian misalignment on ghrelin has not been systematically studied. Here we show-by using two 8-day laboratory protocols-that circulating active (acylated) ghrelin levels are significantly impacted by endogenous circadian phase in healthy adults. Active ghrelin levels were higher in the biological evening than the biological morning (fasting +15.1%, P = 0.0001; postprandial +10.4%, P = 0.0002), consistent with the circadian variation in hunger (P = 0.028). Moreover, circadian misalignment itself (12-h behavioral cycle inversion) increased postprandial active ghrelin levels (+5.4%; P = 0.04). While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05). Our results provide possible mechanisms for the endogenous circadian rhythm in hunger, as well as for the increased risk of obesity among shift workers.",2019,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).",['healthy adults'],[],"['Active ghrelin levels', 'postprandial active ghrelin levels', 'circadian variation in hunger', 'hunger']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]",,0.0482443,"While not significantly influencing hunger (P > 0.08), circadian misalignment increased appetite for energy-dense foods (all P < 0.05).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. jqian@bwh.harvard.edu.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Morris', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Garaulet', 'Affiliation': 'Department of Physiology, Chronobiology Laboratory, University of Murcia and Research Biomedical Institute of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank A J L', 'Initials': 'FAJL', 'LastName': 'Scheer', 'Affiliation': ""Medical Chronobiology Program, Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA. fscheer@bwh.harvard.edu.""}]",International journal of obesity (2005),['10.1038/s41366-018-0208-9'] 46,32348960,Sacubitril/valsartan increases postprandial gastrin and cholecystokinin in plasma.,"Aims Neprilysin degrades natriuretic peptides in circulation and is also suggested to degrade the gut hormones gastrin and cholecystokinin. Neprilysin inhibition has become a therapeutic strategy and thus a regimen in need of further testing in terms of other hormonal axes besides natriuretic peptides. The aim of this study was to examine whether acute inhibition of neprilysin affects meal-induced responses in gastrin and cholecystokinin concentrations in healthy individuals. Methods and results Nine healthy young men were included in an open-labelled, randomized cross-over clinical trial. The participants received a standardized meal (25 g fat, 26 g protein, 42 g carbohydrate) on two separate days with or without a one-time dosage of sacubitril ((194 mg)/valsartan (206 mg)). Blood pressure, heart rate and blood samples were measured and collected during the experiment. Statistical differences between groups were assessed using area under the curve together with an ANOVA with a Bonferroni post hoc test. Sacubitril/valsartan increased the postprandial plasma concentrations of both gastrin and cholecystokinin (80% (AUC0-270 min, P = 0.004) and 60% (AUC0-270 min, P = 0.003), respectively) compared with the control meal. No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96). Conclusion Our study demonstrates that sacubitril/valsartan increases the postprandial plasma concentrations of gastrin and cholecystokinin in healthy individuals. The results thus suggest that neprilysin-mediated degradation of gastrin and cholecystokinin is physiologically relevant and may have a role in heart failure patients treated with sacubitril/valsartan.",2020,"No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96). ","['Nine healthy young men', 'heart failure patients treated with', 'healthy individuals']","['standardized meal', 'Sacubitril/valsartan', 'sacubitril/valsartan']","['Blood pressure, heart rate and blood samples', 'postprandial plasma concentrations of both gastrin and cholecystokinin', 'gastrin and cholecystokinin concentrations', 'postprandial plasma concentrations of gastrin and cholecystokinin', 'postprandial gastrin and cholecystokinin in plasma', 'hemodynamic effects']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017151', 'cui_str': 'Gastrins'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",9.0,0.0323268,"No significant hemodynamic effects were noted (blood pressure, AUC0-270 min, P = 0.86, heart rate, AUC0-270 min, P = 0.96). ","[{'ForeName': 'Ulrik Ø', 'Initials': 'UØ', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dijana', 'Initials': 'D', 'LastName': 'Terzic', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai Jacob', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dall Mark', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Plomgaard', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}]",Endocrine connections,['10.1530/EC-19-0563'] 47,32353739,Real time SVD-based clutter filtering using randomized singular value decomposition and spatial downsampling for micro-vessel imaging on a Verasonics ultrasound system.,"Singular value decomposition (SVD)-based clutter filters can robustly reject the tissue clutter as compared with the conventional high pass filter-based clutter filters. However, the computational burden of SVD makes real time SVD-based clutter filtering challenging (e.g. frame rate at least 10-15 Hz with region of interest of about 4 × 4 cm 2 ). Recently, we proposed an acceleration method based on randomized SVD (rSVD) clutter filtering and randomized spatial downsampling, which can significantly reduce the computational complexity without compromising the clutter rejection capability. However, this method has not been implemented on an ultrasound scanner and tested for its performance. In this study, we implement this acceleration method on a Verasonics scanner using a multi-core CPU architecture, and evaluate the selections of the imaging and processing parameters to enable real time micro-vessel imaging. The Blood-to-Clutter Ratio (BCR) performance was evaluated on a Verasonics machine with different settings of parameters such as block size and ensemble size. The demonstration of real time process was implemented on a 12-core CPU (downsampling factor of 12, 12-threads in this study) host computer. The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively. We also demonstrate that the micro-vessel imaging frame rate of the proposed architecture can reach approximately 22 Hz when the block size, ensemble size and the rank of tissue clutter subspace were set as 20 × 20 pixels, 45 and 26 respectively (using both images and supplementary videos). The proposed method may be important for real time 2D scanning of tumor microvessels in 3D to select and store the most representative 2D view with most abnormal micro-vessels for better diagnosis.",2020,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.",[],[],"['Blood-to-Clutter Ratio (BCR) performance', 'processing time of the rSVD-based clutter filter']",[],[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039010', 'cui_str': 'Swine Vesicular Disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0180860', 'cui_str': 'Filter'}]",,0.0321407,"The processing time of the rSVD-based clutter filter was less than 30 ms and BCRs were higher than 20 dB as the block size, ensemble size and the rank of tissue clutter subspace were set as 30 × 30, 45 and 26 respectively.","[{'ForeName': 'U-Wai', 'Initials': 'UW', 'LastName': 'Lok', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Trzasko', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Daigle', 'Affiliation': 'Verasonics Inc., Kirkland, WA, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Borisch', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Chengwu', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Ultrasound, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Shigao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA. Electronic address: Chen.Shigao@mayo.edu.'}]",Ultrasonics,['10.1016/j.ultras.2020.106163'] 48,32357445,Dietary Intervention through Flipped Learning as a Techno Pedagogy for the Promotion of Healthy Eating in Secondary Education.,"Technological progress in the educational field has led to the application of active and innovative teaching methods, such as flipped learning, including in the field of dietary education. This is considered a mixed formative approach that combines face-to-face and outside the classroom education. The objective of this research was to analyze the effectiveness of flipped learning methodology on a traditional training practice in dietary training, both in the sixth grade of primary education and in the fourth level of secondary education. A quasi-experimental design was adopted with two experimental groups, two control groups and only posttest. The final sample was composed of 115 students divided into four groups, two of each educational stage mentioned. A didactic unit consisting of six sessions in all groups was applied. Two different training methodologies were followed according to the nature of the group (control-traditional; experimental-flipped learning). The results reveal that flipped learning is effective both in primary education and in secondary education, being more influential in student development in this last stage. It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.",2020,It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.,"['115 students divided into four groups, two of each educational stage mentioned', 'Healthy Eating in Secondary Education']",['Dietary Intervention through Flipped Learning'],[],"[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],115.0,0.0136494,It is concluded that the flipped learning approach has meant an improvement of the academic indicators evaluated after a diet education program.,"[{'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López Núñez', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Belmonte', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Antonio-José', 'Initials': 'AJ', 'LastName': 'Moreno-Guerrero', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Marín-Marín', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17093007'] 49,32361279,Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.,"BACKGROUND Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications. RESULTS A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm. CONCLUSIONS In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.",2020,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","['A total of 17 studies with 11,992 patients were included in the current TSA', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction']","['TRA', 'transradial access (TRA) versus transfemoral access (TFA', 'percutaneous coronary intervention', 'Radial versus femoral access']","['MI and stroke', '30-day mortality, major bleeding, MACE and access site complication rates', '30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications', 'major bleeding', '30-day mortality', 'access site complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",11992.0,0.316525,"The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA. Electronic address: Mohammed.Osman@hsc.wvu.edu.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Khansa', 'Initials': 'K', 'LastName': 'Osman', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Babikir', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Regner', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Qais', 'Initials': 'Q', 'LastName': 'Radaideh', 'Affiliation': 'Division of Internal Medicine, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Moreland', 'Affiliation': 'Division of Cardiology, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Department of Cardiovascular Medicine, Cleveland Clinic, OH, USA.'}]",American heart journal,['10.1016/j.ahj.2020.03.014'] 50,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION The best treatment strategy for mild ulnar neuropathy at the elbow (UNE) is not known, due to lack of trials comparing surgery vs conservative treatment. METHODS We recruited patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis. Patients were randomly allocated to either in situ decompression or conservative treatment. The primary outcome was the proportion of patients with subjective symptom improvement at short-term (3 months) and long-term (6-12 months) follow-up. RESULTS One hundred seventeen patients were included: 56 and 61 patients were allocated to surgery and conservative treatment, respectively. A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% vs 50%; odds ratio, 5.6; P < .001), but no differences were observed at long-term follow-up. DISCUSSION In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up. ","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up. ","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912'] 51,32343994,Effects of electronic cigarette on platelet and vascular function after four months of use.,"We examined the effects of electronic cigarette on platelet and vascular function after 4 months of use compared to tobacco smoking. Forty smokers without cardiovascular disease were randomized to smoke either conventional cigarettes or an electronic cigarette (nicotine concentration of 12 mg/ml). At baseline and after four months, we measured a) platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level. After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045). Conversely, compared to smoking, vaping resulted in greater reduction of exhaled CO (6.9 ppm vs 2.6, p for interaction < 0.001), improvement of PWV (decrease of 0.8 m/s vs increase of 0.8 m/s, p for interaction = 0.020) and reduction of MDA (reduction 0.13 vs increase 0.19 nmol/L, p for interaction = 0.035). Switching to electronic cigarette for 4 months has a neutral effect on platelet function while it reduces arterial stiffness and oxidative stress compared to tobacco smoking.",2020,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).",['Forty smokers without cardiovascular disease'],"['electronic cigarette', 'conventional cigarettes or an electronic cigarette (nicotine concentration of 12\u202fmg/ml']","['exhaled CO', 'platelet function', 'platelet and vascular function', 'improvement of PWV', 'arterial stiffness and oxidative stress', 'reduction of MDA', 'platelet function by Platelet Function Analyzer PFA-100 and Light Transmission Aggregometry, b) pulse wave velocity, c) plasma malondialdehyde levels as oxidative stress index and d) the exhaled CO level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",40.0,0.0199673,"After 4 months, continuation of conventional cigarette smoking further impaired platelet function compared to vaping as assessed by PFA (mean increase 27.1 vs 11.6 s, p for interaction = 0.048) and by LTA (decline 24.1 vs 9.4%, p for interaction = 0.045).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ignoik@gmail.com.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Gavriella', 'Initials': 'G', 'LastName': 'Kostelli', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Kallirhoe', 'Initials': 'K', 'LastName': 'Kourea', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kyriakou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Kypraiou', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Department of Pharmaceutical Chemistry, National and Kapodistrian University of Athens, School of Pharmacy, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Thymis', 'Affiliation': ""Laboratory of Preventive Cardiology and Smoking Cessation Clinic, Second Cardiology Department, 'Attikon University Hospital', Medical School, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Argirios E', 'Initials': 'AE', 'LastName': 'Tsantes', 'Affiliation': 'Laboratory of Haematology & Blood Bank Unit, ""Attikon"" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111389'] 52,32344133,Unilateral or Bilateral Percutaneous Endoscopic Debridement and Lavage Treatment for Lumbar Spinal Tuberculosis.,"OBJECTIVE To compare the clinical outcome between bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment for lumbar spine tuberculosis (LST). METHODS A total of 40 patients with LST who underwent either bilateral PEDL (group A) or unilateral PEDL (group B) were reviewed. Perioperative parameters were assessed by operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage. Clinical outcomes were evaluated in the Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). All patients were followed-up for at least 18 months after treatment. RESULTS The average operative time and intraoperative fluoroscopy time were increased in group A compared with those in group B. There was no statistical significance between the 2 groups in postoperative continuous irrigation and vacuum drainage days. The ESR and CRP curves in the 2 groups showed a similar trend during 18-month follow-up. The VAS and ODI in the 2 groups significantly decreased 6 and 18 months postsurgery. There was no significant difference in the incidence of complication between the 2 groups. CONCLUSIONS Two procedures yielded comparable and satisfactory results. Unilateral PEDL showed shorter operative time and decreased intraoperative fluoroscopy times compared with bilateral PEDL. We suggest the use of unilateral PEDL rather than bilateral PEDL in the treatment of LST.",2020,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"['lumbar spinal tuberculosis', 'A total of 40 patients with LST who underwent either', 'lumbar spine tuberculosis (LST']","['unilateral PEDL', 'bilateral PEDL', 'bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment', 'Unilateral or bilateral percutaneous endoscopic debridement and lavage treatment']","['intraoperative fluoroscopy times', 'ESR and CRP curves', 'Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR) and C-reactive protein(CRP', 'VAS and ODI', 'average operative time and the intraoperative fluoroscopy times', 'incidence of complication', 'operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage', 'shorter operative time']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0041330', 'cui_str': 'Tuberculosis of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",40.0,0.0250191,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"[{'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China; Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: docweiminfan@126.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.132'] 53,32348539,Impact of Systemic Dipeptidyl Peptidase-4 Inhibitor Use in Diabetic Macular Edema.,"BACKGROUND AND OBJECTIVE To evaluate impact of baseline systemic dipeptidyl peptidase-4 (DPP-4) inhibitor use in diabetic macular edema (DME). PATIENTS AND METHODS This was a post hoc exploratory analysis of previously completed randomized, controlled clinical trials (VISTA and VIVID) in patients with DME evaluating intravitreal aflibercept injection (IAI) every 4 weeks (2q4) or every 8 weeks (2q8) or macular laser photocoagulation. RESULTS Overall, a small number of patients (12.2% [n = 35], 9.7% [n = 28], and 15.4% [n = 44]) in the laser control, 2q4, and 2q8 groups reported baseline DPP-4 inhibitor use. There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. CONCLUSION DPP-4 inhibitor use at baseline did not influence the magnitude of visual and anatomic benefit in patients with DME being treated with IAI or laser. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:226-234.].",2020,"There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. ","['Diabetic Macular Edema', 'patients with DME evaluating intravitreal aflibercept injection (IAI) every 4 weeks (2q4) or every 8 weeks (2q8) or', 'diabetic macular edema (DME', 'patients with DME being treated with IAI or laser']","['Systemic Dipeptidyl Peptidase-4 Inhibitor Use', 'macular laser photocoagulation', 'baseline systemic dipeptidyl peptidase-4 (DPP-4) inhibitor']","['magnitude of visual and anatomic benefit', 'best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.233762,"There were no differences in changes from baseline in best-corrected visual acuity, central subfield thickness, or rates of 2-or-greater-step improvement in Diabetic Retinopathy Severity Scale score based on DPP-4 inhibitor use within each treatment group. ","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Rahimy', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200326-04'] 54,32349223,Effects of Small-Sided Recreational Volleyball on Health Markers and Physical Fitness in Middle-Aged Men.,"The present study aimed to investigate whether recreational volleyball organized as small-sided games could improve fitness and health profiles of middle-aged men after 10 weeks of training. Twenty-four healthy men aged 35-55 were randomized in a small-sided recreational volleyball group (RV = 12; age: 44.7 ± 6.34 years; body mass index: 25.85 ± 1.74) and control group (CON = 12; age: 42.9 ± 8.72 years; body mass index: 25.62 ± 1.48). The RV group carried out a volleyball training program, whereas the CON group continued their daily life activities during this period. The participants in the RV group performed 2/3 training sessions of 90 min per week. Results from a repeated measure ANOVA indicated a significant group × time interaction for low-density lipoprotein (LDL) cholesterol (F = 6.776, p = 0.016, partial ƞ 2 = 0.235) and for resting heart rate (F = 11.647, p = 0.002, partial ƞ 2 = 0.346) in favor of the RV group. No significant changes were observed for body weight, body mass index, and diastolic blood pressure. Results for physical fitness indicated a significant interaction for Yo-Yo intermittent recovery test-level 2 (F = 11.648, p = 0.003, partial ƞ 2 = 0.380), with no significant changes in both groups for handgrip strength. Recreational small-sided volleyball can be an effective training modality to stimulate a decrease in LDL cholesterol and resting HR with small improvements in cardiovascular fitness. Recreational volleyball played only two times per week shows positive cardiovascular fitness and health-related adaptations, which may contribute to the reduction of the risk of developing lifestyle diseases.",2020,"Results for physical fitness indicated a significant interaction for Yo-Yo intermittent recovery test-level 2 (F = 11.648, p = 0.003, partial ƞ 2 = 0.380), with no significant changes in both groups for handgrip strength.","['middle-aged men after 10 weeks of training', 'Twenty-four healthy men aged 35-55 were randomized in a small-sided recreational volleyball group (RV = 12; age: 44.7 ± 6.34 years; body mass index: 25.85 ± 1.74) and control group (CON = 12; age: 42.9 ± 8.72 years; body mass index: 25.62 ± 1.48', 'Middle-Aged Men']","['volleyball training program', 'CON', 'recreational volleyball organized as small-sided games', 'Small-Sided Recreational Volleyball']","['Health Markers and Physical Fitness', 'LDL cholesterol and resting HR', 'resting heart rate', 'time interaction for low-density lipoprotein (LDL) cholesterol ', 'handgrip strength', 'body weight, body mass index, and diastolic blood pressure', 'fitness and health profiles']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517773', 'cui_str': '42.9'}]","[{'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",24.0,0.0215048,"Results for physical fitness indicated a significant interaction for Yo-Yo intermittent recovery test-level 2 (F = 11.648, p = 0.003, partial ƞ 2 = 0.380), with no significant changes in both groups for handgrip strength.","[{'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21101 Novi Sad, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Sporiš', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10110 Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Krističević', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10110 Zagreb, Croatia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17093021'] 55,32350749,A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.,"BACKGROUND In recent randomized, placebo-controlled, phase III trials, highly purified cannabidiol demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome. It is anticipated that antiepileptic drugs such as stiripentol and valproate will be administered concomitantly with cannabidiol. OBJECTIVES This trial evaluated the effect of cannabidiol on steady-state pharmacokinetics of stiripentol or valproate in patients with epilepsy, and the safety and tolerability of cannabidiol. METHODS This phase II, two-arm, parallel-group, double-blind, randomized, placebo-controlled trial recruited male and female patients with epilepsy aged 16-55 years. Patients receiving a stable dose of stiripentol or valproate were randomized 4:1 to receive concomitant double-blind cannabidiol or placebo. Patients received plant-derived, highly purified cannabidiol medicine (Epidiolex ® in the USA; Epidyolex ® in the EU; 100 mg/mL oral solution) at a dose of 20 mg/kg/day from day 12 to 26, following a 10-day dose-escalation period. Blood samples for pharmacokinetic evaluations were collected on days 1 and 26 before stiripentol/valproate dosing and up to 12 h postdose. Treatment-emergent adverse events (AEs) were recorded. RESULTS In total, 35 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21). Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol). The safety population of the valproate arm comprised 20 patients (4 placebo; 16 cannabidiol; one withdrew before receiving treatment); the pharmacokinetic population comprised 15 patients (3 placebo; 12 cannabidiol). Concomitant cannabidiol led to a small increase in stiripentol exposure (17% increase in maximum observed plasma concentration [C max ]; 30% increase in area under the concentration-time curve over the dosing interval [AUC tau ]). Concomitant cannabidiol also had little effect on valproate exposure (13% decrease in C max ; 17% decrease in AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA) (23% decrease in C max ; 30% decrease in AUC tau ). All changes in exposure are expressed as the dose-normalized geometric mean (CV%) day 26 to day 1 ratio. The most common AE was diarrhea; most AEs were mild. Two patients discontinued cannabidiol because of serious AEs (rash [n = 1] in the stiripentol arm; hypertransaminasemia [n = 1] in the valproate arm). A separate in vitro study investigated the bidirectional effect of cannabidiol, or its metabolite 7-carboxy-cannabidiol, on valproate plasma protein binding; no change in plasma protein binding was observed for either compound. CONCLUSIONS The clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.",2020,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","['Patients receiving a stable dose of', 'controlled trial recruited male and female patients with epilepsy aged 16-55 years', '20 patients (4', 'patients with epilepsy', 'adult patients with epilepsy', 'In total,\xa035 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21', 'Patients with Epilepsy', 'patients with Lennox-Gastaut syndrome or Dravet syndrome']","['concomitant double-blind cannabidiol or placebo', 'placebo', 'valproate', 'Stiripentol or Valproate', 'plant-derived, highly purified cannabidiol medicine (Epidiolex ® in the USA; Epidyolex ® in the EU; 100 mg/mL oral solution', 'stiripentol or valproate']","['stiripentol exposure', 'valproate exposure', 'AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA', 'plasma protein binding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0046536', 'cui_str': '2-propyl-4-pentenoic acid'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",35.0,0.419758,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Clinical Neuroscience at Institute of Neuroscience and Physiology, Neurologen, University of Gothenburg, Blå Stråket 7, Plan 0, 41345, Gothenburg, Sweden. elinor.ben-menachem@neuro.gu.se.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Carmen María', 'Initials': 'CM', 'LastName': 'Arenas Cabrera', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Kevan', 'Initials': 'K', 'LastName': 'VanLandingham', 'Affiliation': 'Greenwich Biosciences, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wray', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Toledo', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",CNS drugs,['10.1007/s40263-020-00726-4'] 56,32349413,Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study.,"The present study examined whether a culture-based virtual reality (VR) training program is feasible and tolerable for patients with amnestic mild cognitive impairment (aMCI), and whether it could improve cognitive function in these patients. Twenty-one outpatients with aMCI were randomized to either the VR-based training group or the control group in a 1∶1 ratio. The VR-based training group participated in training for 30 min/day, two days/week, for three months (24 times). The VR-based program was designed based on Korean traditional culture and used attention, processing speed, executive function and memory conditions to stimulate cognitive function. The adherence to the culture-based VR training program was 91.55% ± 6.41% in the VR group. The only adverse events observed in the VR group were dizziness (4.2%) and fatigue (8.3%). Analysis revealed that the VR-based training group exhibited no significant differences following the three-month VR program in Korean Mini-Mental State Examination (K-MMSE) scores, working memory functions such as performance on the digit span test, or in Stroop test performance and word fluency. We conclude that although the 12-week culture-based VR training program did not improve cognitive function, our findings revealed that the culture-based VR training program was feasible and tolerable for participants with aMCI.",2020,The adherence to the culture-based VR training program was 91.55% ± 6.41% in the VR group.,"['patients with amnestic mild cognitive impairment (aMCI', 'Twenty-one outpatients with aMCI', 'participants with aMCI', 'Patients with Mild Cognitive Impairment']","['VR-based training group or the control', 'culture-based virtual reality (VR) training program', 'Culture-Based Virtual Reality (VR) Training Program']","['dizziness', 'fatigue', 'Feasibility and Tolerability', 'cognitive function', 'Korean Mini-Mental State Examination (K-MMSE) scores, working memory functions such as performance on the digit span test, or in Stroop test performance and word fluency', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",21.0,0.0105873,The adherence to the culture-based VR training program was 91.55% ± 6.41% in the VR group.,"[{'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Health Convergence Medicine Laboratory, Biomedical Research Institute, Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Yung', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Health Promotion and Health Education, National Taiwan Normal University, Taipei 10610, Taiwan.'}, {'ForeName': 'Du-Ri', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'Health Convergence Medicine Laboratory, Biomedical Research Institute, Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Seunghwan', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Pusan National University School of Medicine, Biomedical Research Institute, Pusan National University Hospital, Busan 49241, Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Neurology, College of Medicine, Dong-A University, Busan 49201, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Yeanhwa', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'SY Inotech, Busan 48520, Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, College of Medicine, Dong-A University, Busan 49201, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093030'] 57,32353342,"Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial.","BACKGROUND Patients with HER2-positive breast cancer who have received two or more previous therapies for advanced disease have few effective treatment options. The monarcHER trial aimed to compare the efficacy of abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab in women with advanced breast cancer. METHODS This phase 2, three-group, open-label trial was done across 75 hospitals, clinics, and medical centres in 14 countries. Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease. Patients were randomly assigned 1:1:1 to the abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab (group C). Oral abemaciclib 150 mg 12 hourly was administered on days 1-21 of a 21-day cycle, intravenous trastuzumab 8 mg/kg on cycle 1 day 1, followed by 6 mg/kg on day 1 of each subsequent 21-day cycle, and intramuscular fulvestrant 500 mg on days 1, 15, and 29 and once every 4 weeks thereafter. Standard-of-care chemotherapy was administered as specified by the product label. Randomisation was by a computer-generated random sequence by means of an interactive web-response system and stratified by number of previous systemic therapies for advanced breast cancer and measurable versus non-measurable disease. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, first testing group A versus group C and, if this result was significant, then group B versus group C. Safety was assessed in all patients who had received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov (NCT02675231) and is ongoing for long-term survival follow-up. FINDINGS Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients were enrolled and randomly assigned to groups A (n=79), B (n=79), and C (n=79). Median follow-up was 19·0 months (IQR 14·7-25·1). The study met its primary endpoint, showing a significant difference at the prespecified two-sided α of 0·2 in median progression-free survival between group A (8·3 months, 95% CI 5·9-12·6) and group C (5·7 months, 5·4-7·0; HR 0·67 [95% CI 0·45-1·00]; p=0·051). No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77). The most common grade 3-4 treatment-emergent adverse event in groups A, B, and C was neutropenia (21 [27%] of 78 patients, 17 [22%] of 77, and 19 [26%] of 72). The most common serious adverse events were: in group A, pyrexia (three [4%]), diarrhoea (two [3%]), urinary tract infection (two [3%]), and acute kidney injury (two [3%]); in group B, diarrhoea (two [3%]) and pneumonitis (two [3%]); and in group C, neutropenia (four [6%]) and pleural effusion (two [3%]). Two deaths were attributed to treatment: one due to pulmonary fibrosis in group B and one due to febrile neutropenia in group C. INTERPRETATION The combination of abemaciclib, fulvestrant, and trastuzumab significantly improved progression-free survival versus standard-of-care chemotherapy plus trastuzumab while showing a tolerable safety profile. Our results suggest that a chemotherapy-free regimen might potentially be an alternative treatment option for patients with hormone receptor-positive, HER2-positive advanced breast cancer. FUNDING Eli Lilly and Company.",2020,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","['women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER', '75 hospitals, clinics, and medical centres in 14 countries', 'patients with hormone receptor-positive, HER2-positive advanced breast cancer', 'Patients with HER2-positive breast cancer', 'Between May 31, 2016, and Feb 28, 2018, 325 patients were screened, of whom 237 eligible patients', 'women with advanced breast cancer', 'Eligible patients were women aged 18 years or older, who had hormone receptor-positive, HER2-positive advanced breast cancer with unresectable, locally advanced, recurrent or metastatic disease, Eastern Cooperative Oncology Group performance status of 0 or 1, and who had previously received at least two HER2-targeted therapies for advanced disease']","['Standard-of-care chemotherapy', ""abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab"", 'Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy', 'Oral abemaciclib', 'abemaciclib, trastuzumab, and fulvestrant (group A), abemaciclib and trastuzumab (group B), or standard-of-care chemotherapy and trastuzumab']","['pneumonitis', 'febrile neutropenia', 'neutropenia', 'median progression-free survival', 'progression-free survival', 'acute kidney injury', 'diarrhoea', 'pyrexia', 'urinary tract infection', 'pleural effusion', 'investigator-assessed progression-free survival']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",325.0,0.211064,"No difference was observed between median progression-free survival in group B (5·7 months, 95% CI 4·2-7·2) and group C (HR 0·94 [0·64-1·38]; p=0·77).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: sara_tolaney@dfci.harvard.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wardley', 'Affiliation': 'The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zambelli', 'Affiliation': 'Istituto Di Ricovero e Cura a Carattere Scientifico, Ospedale San Raffaele, IRCCS, Milano, Italy.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Troso-Sandoval', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, PSL Research University, Department of Medical Oncology, Paris, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Stephen Rd', 'Initials': 'SR', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-WA, Nedlands, WA, Australia; Curtin University, Nedlands, WA, Australia.'}, {'ForeName': 'Shom', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Catron', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Sonya C', 'Initials': 'SC', 'LastName': 'Chapman', 'Affiliation': 'Eli Lilly, Windlesham, UK.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'M Corona', 'Initials': 'MC', 'LastName': 'Gainford', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Gustave Roussy, Université Paris Saclay, INSERM, Villejuif, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30112-1'] 58,32356185,High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience.,"The aim of this work was assessment of the efficacy and tolerability of two different regimens for retreatment of hepatitis C virus (HCV) patients who failed to respond to SOF/DCV-based therapy. This prospective study included 104 HCV patients who failed to respond to SOF/DCV-based therapy. Patients were randomly allocated to two groups. Efficacy and tolerability were assessed. The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000). Most adverse events reported were mild to moderate, with no deaths during the study. Multi-target direct-acting antiviral (DAA) combinations are efficient for retreatment of HCV patients after failure of SOF/DCV-based therapy in real-world management.ClinicalTrials.gov identifier: NCT02992457.",2020,"The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000).","['104 HCV patients who failed to respond to SOF/DCV-based therapy', 'hepatitis C virus (HCV) patients who failed to respond to SOF/DCV-based therapy', 'HCV patients after failure of SOF/DCV-based therapy in real-world management']","['Multi-target direct-acting antiviral (DAA) combinations', 'sofosbuvir/ombitasvir/paritaprevir/ritonavir\u2009+\u2009ribavirin and sofosbuvir/simeprevir/daclatasvir\u2009+\u2009ribavirin']","['virological response (SVR12) rates', 'Efficacy and tolerability', 'efficacy and tolerability']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3864967', 'cui_str': 'ombitasvir, paritaprevir and ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C2605855', 'cui_str': 'simeprevir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",104.0,0.0180318,"The 12-week sustained virological response (SVR12) rates were 96% and 94.4% in groups B and A, respectively, with no significant difference (p = 1.000).","[{'ForeName': 'Ebada Mohamed', 'Initials': 'EM', 'LastName': 'Said', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Badawy A', 'Initials': 'BA', 'LastName': 'Abdulaziz', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Kassas', 'Affiliation': 'Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim Hussein', 'Initials': 'IH', 'LastName': 'El Attar', 'Affiliation': 'Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Emadeldeen', 'Affiliation': 'National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.'}, {'ForeName': 'Sherief M', 'Initials': 'SM', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine Department, Tanta University, Tanta, Egypt. sherif.abdelbaky@med.tanta.edu.eg.'}]",Archives of virology,['10.1007/s00705-020-04639-x'] 59,32363771,Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity.,"AIMS Adalimumab-adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab-adbm and Humira in patients with active rheumatoid arthritis (RA), to quantify the effects of potential covariates on adalimumab PK and to assess the impact of switching treatment from Humira to adalimumab-adbm on PK. METHODS A PPK model was firstly developed using intensive PK data from the phase-1 study in healthy subjects (NCT02045979). PPK models were developed separately for phase-3 base study (NCT02137226) and its extension study (NCT02640612) in patients with active RA. RESULTS PPK models were developed for adalimumab from adalimumab-adbm and Humira treatment in healthy subjects and RA patients. Weight and anti-drug antibodies were found to be important predictors of adalimumab clearance. Adalimumab PK was similar between adalimumab-adbm and Humira. The estimated effect of Humira on clearance, relative to the adalimumab-adbm, was 1.02 (i.e., Humira has 0.02 greater clearance). Similarly, the effect of treatment arms (switching) on clearance was estimated to be 1.00 and 0.997 for Humira:Humira:BI and Humira:BI:BI arms, respectively, relative to the BI:BI:BI arm (BI refers to adalimumab-adbm) in the phase-3 extension study. CONCLUSION PK similarity between adalimumab-adbm and Humira in patients with active RA was demonstrated using PPK approach. Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.",2020,Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.,"['healthy subjects and patients with rheumatoid arthritis', 'patients with active rheumatoid arthritis (RA', 'patients with active RA', 'healthy subjects and RA patients', 'healthy subjects (NCT02045979']","['Adalimumab PK', 'adalimumab biosimilar adalimumab-adbm', 'adalimumab-adbm and Humira']","['pharmacokinetic (PK) similarity', 'Weight and anti-drug antibodies (ADA', 'clearance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4530556', 'cui_str': 'Adalimumab-adbm'}, {'cui': 'C1171255', 'cui_str': 'Humira'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0232379,Adalimumab PK was also similar when switching treatment from Humira to adalimumab-adbm at either week 24 or 48.,"[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'Rena J', 'Initials': 'RJ', 'LastName': 'Eudy-Byrne', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mondick', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Knebel', 'Affiliation': 'Metrum Research Group, Tariffville, Connecticut, USA.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Jayadeva', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Liesenfeld', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, an der Riss, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14330'] 60,32366577,The Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering on Cardiovascular Outcomes and All-Cause Mortality in Type 2 Diabetes.,"OBJECTIVE To examine whether low baseline diastolic blood pressure (DBP) modifies the effects of intensive systolic blood pressure (SBP) lowering on cardiovascular outcomes in type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS The Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial (ACCORD BP), a two-by-two factorial randomized controlled trial, examined effects of SBP (<120 vs. <140 mmHg) and glycemic (HbA 1c <6% vs. 7.0-7.9% [<42 vs. 53-63 mmol/mol]) control on cardiovascular events in T2DM ( N = 4,731). We examined whether effects of SBP control on cardiovascular composite were modified by baseline DBP and glycemic control. RESULTS Intensive SBP lowering decreased the risk of the cardiovascular composite (hazard ratio [HR] 0.76 [95% CI 0.59-0.98]) in the standard glycemic arm but not in the intensive glycemic arm (HR 1.06 [95% CI 0.81-1.40]). Spline regression models relating the effects of the intervention on the cardiovascular composite across the range of baseline DBP did not show evidence of effect modification by low baseline DBP for the cardiovascular composite in the standard or intensive glycemic arms. The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P = 0.83). CONCLUSIONS In persons with T2DM, intensive SBP lowering decreased the risk of cardiovascular composite end point irrespective of baseline DBP in the setting of standard glycemic control. Hence, low baseline DBP should not be an impediment to intensive SBP lowering in patients with T2DM treated with guidelines recommending standard glycemic control.",2020,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P = 0.83). ","['Type 2 Diabetes', 'type 2 diabetes mellitus (T2DM']","['low baseline diastolic blood pressure (DBP', 'Intensive Blood Pressure Lowering', 'intensive SBP intervention', 'intensive systolic blood pressure (SBP) lowering', 'SBP control', 'SBP']","['cardiovascular events', 'risk of the cardiovascular composite (hazard ratio [HR', 'risk of cardiovascular composite', 'cardiovascular outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4274392', 'cui_str': 'Baseline diastolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0567952,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P = 0.83). ","[{'ForeName': 'Olesya L', 'Initials': 'OL', 'LastName': 'Ilkun', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT srinivasan.beddhu@hsc.utah.edu.'}]",Diabetes care,['10.2337/dc19-2047'] 61,32363608,Development and preliminary validation of the Meaningful and Enjoyable Activities Scale (MEAS) in mild dementia.,"BACKGROUND Engaging in meaningful activity is an important contributor to well-being in late life. This study aimed to develop a new measure of meaningful and enjoyable activities in people living with mild dementia. METHODS The study consisted of four phases: (a) a review of measures of meaningful activity in older people; (b) interviews with people with dementia and their carers (n = 32), (c) expert opinion; and (d) feasibility testing in a pilot randomised controlled trial (n = 63). RESULTS The development process resulted in a 20-item questionnaire. The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = .79). Higher scores correlated with higher functional independence (r = -.605, P < .001), patient (r = .330, P = .010) and carer-rated patient quality of life (r = .505, P < .001). Multiple regression analyses showed that functional independence made a significant independent contribution in predicting higher levels of meaningful activity (F[7,45] = 6.75, P < .001, R 2 = .512; β = -.444, P = .001). Confirmatory factor analysis indicated that a revised three-factor 9-item model provided good fit for the data (X 2 = 22.74, P = .54, GFI = 0.93, RMSE = 0.00), with leisure-time physical activity, social engagement and mentally stimulating activities as the key dimensions. CONCLUSION Our study provides support for the construct of meaningful activity in people with mild dementia. Although we find preliminary evidence that the MEAS has adequate psychometric properties, future large scale studies are required to test its validity further and responsiveness to change.",2020,The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = 0.79).,"['people with mild dementia', 'mild dementia', 'older people; 2) interviews with people with dementia and their carers (n\xa0=\xa032', 'people living with mild dementia']",['MEAS'],"['carer-rated patient quality of life', 'functional independence', 'Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency', 'Meaningful and Enjoyable Activities Scale (MEAS', 'meaningful activity', 'leisure-time physical activity, social engagement and mentally stimulating activities']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0439073,The Meaningful and Enjoyable Activities Scale (MEAS) evidenced appropriate levels of internal consistency (α = 0.79).,"[{'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Tuijt', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Profyri', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Orgeta', 'Affiliation': 'Faculty of Brain Sciences, Division of Psychiatry, University College London, London, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5316'] 62,32305926,Alpha Frequency Intervention by Electrical Stimulation to Improve Performance in Mu-Based BCI.,"The accuracy of brain-computer interfaces (BCIs) is important for effective communication and control. The mu-based BCI is one of the most widely used systems, of which the related methods to improve users' accuracy are still poorly studied, especially for the BCI illiteracy. Here, we examined a way to enhance mu-based BCI performance by electrically stimulating the ulnar nerve of the contralateral wrist at the alpha frequency (10 Hz) during left- and right-hand motor imagination in two BCI groups (literate and illiterate). We demonstrate that this alpha frequency intervention enhances the classification accuracy between left- and right-hand motor imagery from 66.41% to 81.57% immediately after intervention and to 75.28% two days after intervention in the BCI illiteracy group, while classification accuracy improves from 82.12% to 91.84% immediately after intervention and to 89.03% two days after intervention in the BCI literacy group. However, the classification accuracy did not change before and after the sham intervention (no electrical stimulation). Furthermore, the ERD on the primary sensorimotor cortex during left- or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention. Alpha frequency intervention increases the mu-rhythm power difference between left- and right-hand motor imagery tasks. These results provide evidence that alpha frequency intervention is an effective way to improve BCI performance by regulating the mu-rhythm which might provide a way to reduce BCI illiteracy.",2020,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.",[],['Alpha Frequency Intervention by Electrical Stimulation'],"['enhance mu-based BCI performance', 'BCI performance']",[],"[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}]",,0.0148878,"Furthermore, the ERD on the primary sensorimotor cortex during left-or right-hand motor imagery tasks was more visible at the mu-rhythm (8-13 Hz) after alpha frequency intervention.","[{'ForeName': 'Xiangzi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yaqiu', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Boyu', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2987529'] 63,32370635,Gratitude as a Mediator of the Effects of Savoring on Positive Adjustment to Aging.,"We extended the previous experimental work with older adults by testing mediating variables through which savoring valuable ""life lessons"" improves attitudes toward aging and boosts well-being. A sample of 202 adults aged 65 or older were randomly assigned to either an experimental condition (in which they reflected on important lessons life had taught them) or a control condition (in which they reflected on their typical morning routine). Contemplating life lessons increased feelings of gratitude, which in turn boosted positive attitudes toward aging, life satisfaction, state hope, and state self-esteem. Additional analyses supported a three-path mediational model, in which reflecting on life lessons increased levels of savoring, which led to greater gratitude, which in turn predicted stronger positive attitudes toward aging, life satisfaction, and hope. We discuss implications of these findings for future research on savoring interventions for older adults and suggest future directions designed to advance understanding of these experimental effects.",2020,"Contemplating life lessons increased feelings of gratitude, which in turn boosted positive attitudes toward aging, life satisfaction, state hope, and state self-esteem.","['older adults', '202 adults aged 65 or older']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],202.0,0.0286305,"Contemplating life lessons increased feelings of gratitude, which in turn boosted positive attitudes toward aging, life satisfaction, state hope, and state self-esteem.","[{'ForeName': 'Fred B', 'Initials': 'FB', 'LastName': 'Bryant', 'Affiliation': '2456 Department of Psychology, Loyola University Chicago, IL, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Osowski', 'Affiliation': '2456 Department of Psychology, Loyola University Chicago, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Smith', 'Affiliation': 'Mather Institute, Evanston, IL, USA.'}]",International journal of aging & human development,['10.1177/0091415020919999'] 64,32372382,Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials.,"INTRODUCTION The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved for the treatment of adults with type 2 diabetes mellitus (T2DM). This analysis was conducted on safety data pooled from phase 3 studies using ertugliflozin 5 mg or 15 mg versus placebo or an active comparator. METHODS The placebo pool (n = 1544) comprised data from three similarly designed 26-week placebo-controlled studies. The broad pool (n = 4849) comprised these three placebo-controlled studies plus four placebo- or active-controlled studies with treatment durations of up to 104 weeks. RESULTS In the placebo pool, there were no notable differences across groups in the incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication, while associations were observed with genital mycotic infection in both females (3.0%, 9.1%, and 12.2% in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively) and males (0.4%, 3.7%, 4.2%), thirst (0.2%, 1.3%, 1.0%), and increased urination (1.0%, 2.7%, 2.4%). In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥ 65 years, or who were taking diuretics. Ertugliflozin was not associated with increased urinary tract infection, fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, malignancy, or venous thromboembolism. Small numbers of patients were reported with lower limb amputation [0.1% (non-ertugliflozin group), 0.2% (ertugliflozin 5 mg), 0.5% (ertugliflozin 15 mg)]. There were three cases of ketoacidosis (all ertugliflozin 15 mg) and no cases of Fournier's gangrene. CONCLUSION This pooled analysis showed that ertugliflozin was generally well tolerated in a large population of patients with T2DM with and without moderate renal impairment who were taking a range of background diabetes medications including insulin and insulin secretagogs, with results that are generally consistent with those for other SGLT2 inhibitors. TRIAL REGISTRATION Clinicaltrials.gov indentifier, NCT02033889, NCT01958671, NCT02036515, NCT01986855, NCT02099110, NCT02226003, NCT01999218.",2020,"In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥","['65\xa0years, or who were taking diuretics', 'pool (n\u2009=\u20091544', 'patients with T2DM with and without moderate renal impairment', 'adults with type 2 diabetes mellitus (T2DM', 'patients with estimated glomerular filtration rate\u2009<\u200960\xa0ml/min/1.73\xa0m 2 , aged ≥', 'Patients with Type 2 Diabetes Mellitus']","['Ertugliflozin', 'ertugliflozin', 'placebo, ertugliflozin', 'ertugliflozin 5\xa0mg or 15\xa0mg versus placebo', 'placebo-controlled studies plus four placebo', 'sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin', 'placebo']","['incidence of adverse events (AEs), serious AEs, or AEs resulting in discontinuation from study medication', 'urination', 'urinary tract infection, fracture, hypoglycemia, pancreatitis, renal or hepatic injury, hypersensitivity, malignancy, or venous thromboembolism', 'ketoacidosis', 'genital mycotic infection', 'limb amputation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}]",4849.0,0.435138,"In the broad pool, volume depletion was increased with ertugliflozin in patients with estimated glomerular filtration rate < 60 ml/min/1.73 m 2 , aged ≥","[{'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. shrita.patel@merck.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00803-3'] 65,32382745,A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.,"CONTEXT A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial. OBJECTIVE Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy. DESIGN Randomized, active-controlled, open-label study. SETTING AND PATIENTS Academic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old. METHODS Patients were randomized 3:1 to oral TU, as prescribed (JATENZO®; n = 166) or a topical T product once daily (Axiron®; n = 56) for 3 to 4 months. Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by liquid chromatography-mass spectrometry/mass spectrometry. Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP). RESULTS 87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean ± standard deviation) for the oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L); serum T equivalent, ~489 ± 155 ng/dL (17 ± 5 nmol/L); and topical T, 391 ± 140 ng/dL (~14 ± 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg. CONCLUSION A new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.",2020,"Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3-5 mm Hg. CONCLUSION ","[' enrolled patients were clinically hypogonadal men 18-65 years old', 'Hypogonadal Men', 'Patients', 'hypogonadal patients', 'Academic and private clinical practice sites']","['Testosterone Undecanoate Formulation Restores Testosterone', 'oral testosterone (T) undecanoate (TU', 'topical T product QD (Axiron®']","['average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples', 'Safety', 'ambulatory BP', 'Safety profiles', 'systolic BP', 'mean T Cavg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0359087', 'cui_str': 'Testosterone-containing product in oral dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C2961759', 'cui_str': 'Axiron'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.046234,"Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3-5 mm Hg. CONCLUSION ","[{'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, US.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, US.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, US.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Kaminetsky', 'Affiliation': 'Manhattan Medical Research, New York, NY, US.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Gittelman', 'Affiliation': 'UroMedix and South Florida Medical Research, Aventura, FL, US.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth and Associates, Mundelein, IL, US.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Dudley', 'Affiliation': 'Clarus Therapeutics Inc., Northbrook, IL, US.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Danoff', 'Affiliation': 'Clarus Therapeutics Inc., Northbrook, IL, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa238'] 66,32367437,Genetic analysis in patients with newly diagnosed glioblastomas treated with interferon-beta plus temozolomide in comparison with temozolomide alone.,"PURPOSE This study aimed to explore the genetic alterations and to identify good responders in the experimental arm in the tumor samples from newly diagnosed glioblastoma (GBM) patients enrolled in JCOG0911; a randomized phase II trial was conducted to compare the efficacy of interferonβ (IFNβ) plus temozolomide (TMZ) with that of TMZ alone. EXPERIMENTAL DESIGN: Of 122 tumors, we performed deep targeted sequencing to determine the somatic mutations, copy number variations, and tumor mutation burden; pyrosequencing for O 6 -methylguanine-DNA methyltransferase (MGMT) promoter methylation; Sanger sequencing for the telomerase reverse transcriptase (TERT) promoter; and microsatellite instability (MSI) testing in 95, 91, 91 and 72 tumors, respectively. We performed a multivariable Cox regression analysis using backward stepwise selection of variables including clinical factors (sex, age, performance status, residual tumor after resection, tumor location) and genetic alterations. RESULTS Deep sequencing detected an IDH1 mutation in 13 tumors (14%). The MGMT promoter methylation by quantitative pyrosequencing was observed in 41% of the tumors. A mutation in the TERT promoter was observed in 69% of the tumors. While high tumor mutation burden (> 10 mutations per megabase) was seen in four tumors, none of the tumors displayed MSI-high. The clinical and genetic factors considered as independent favorable prognostic factors were gross total resection (hazard ratio [HR]: 0.49, 95% confidence interval, 0.30-0.81, P = 0.0049) and MGMT promoter methylation (HR: 0.43, 0.21-0.88, P = 0.023). However, tumor location at the temporal lobe (HR: 1.90, 1.22-2.95, P = 0.0046) was an independent unfavorable prognostic factor. No predictive factors specific to the TMZ + IFNβ + Radiotherapy (RT) group were found. CONCLUSION This additional sub-analytical study of JCOG0911 among patients with newly diagnosed GBM showed that tumor location at the temporal lobe, gross total resection, and MGMT promoter methylation were significant prognostic factors, although no factors specific to IFNβ addition were identified.",2020,"However, tumor location at the temporal lobe (HR: 1.90, 1.22-2.95, P = 0.0046) was an independent unfavorable prognostic factor.","['patients with newly diagnosed GBM', 'Of 122 tumors', 'patients with newly diagnosed glioblastomas treated with', 'tumor samples from newly diagnosed glioblastoma (GBM) patients enrolled in']","['JCOG0911', 'temozolomide alone', 'TMZ alone', 'TMZ\u2009+\u2009IFNβ\u2009+\u2009Radiotherapy (RT', 'interferon-beta plus temozolomide', 'interferonβ (IFNβ) plus temozolomide (TMZ']",['IDH1 mutation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0364867,"However, tumor location at the temporal lobe (HR: 1.90, 1.22-2.95, P = 0.0046) was an independent unfavorable prognostic factor.","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Natsume', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. anatsume@med.nagoya-u.ac.jp.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Fumiharu', 'Initials': 'F', 'LastName': 'Ohka', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Sachi', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Hirano', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Alimu', 'Initials': 'A', 'LastName': 'Adilijiang', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Sumi', 'Affiliation': 'Radiation Oncology Department, Cancer Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Narita', 'Affiliation': 'Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Muragaki', 'Affiliation': ""Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': ""Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Beppu', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Neurosurgery, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Kayama', 'Affiliation': 'Department of Neurosurgery, Yamagata University Graduate School of Medicine, Yamagata, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Neurosurgery, Yamagata University Graduate School of Medicine, Yamagata, Japan.'}, {'ForeName': 'Motoo', 'Initials': 'M', 'LastName': 'Nagane', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Mishima', 'Affiliation': 'Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nakasu', 'Affiliation': 'Department of Neurosurgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kurisu', 'Affiliation': 'Department of Neurosurgery, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Fumiyuki', 'Initials': 'F', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Neurosurgery, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Clinical Oncology & Neuro-Oncology Program, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Onishi', 'Affiliation': 'Department of Neurosurgery, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iwadate', 'Affiliation': 'Department of Neurological Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Mizuhiko', 'Initials': 'M', 'LastName': 'Terasaki', 'Affiliation': 'Department of Neurosurgery, Kurume University Graduate School of Medicine, Kurume, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Matsumura', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Department of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Akitake', 'Initials': 'A', 'LastName': 'Mukasa', 'Affiliation': 'Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'Department of Neurosurgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Department of Neurosurgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Kumabe', 'Affiliation': 'Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Nobusada', 'Initials': 'N', 'LastName': 'Shinoura', 'Affiliation': 'Department of Neurosurgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Neurosurgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurosurgery, Kitano Hospital, Osaka, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Asai', 'Affiliation': 'Department of Neurosurgery, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Department of Neurological Surgery, Nihon University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Arakawa', 'Affiliation': 'Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Asano', 'Affiliation': 'Department of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Neurosurgery, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Shibui', 'Affiliation': 'Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuno', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neuro-oncology,['10.1007/s11060-020-03505-9'] 67,32359506,"Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation. METHODS In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m 2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m 2 administered orally on days 1-4) and prednisone (60 mg/m 2 administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m 2 ), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m 2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment. FINDINGS Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]). INTERPRETATION This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. FUNDING Janssen and Celgene.",2020,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"['untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network', 'Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein', 'patients with newly diagnosed multiple myeloma', '1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428', '1503 patients were enrolled', 'patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus', 'All patients who received at least one dose of study drugs were included in the safety analyses', 'Between Feb 25, 2011, and April 3, 2014', 'newly diagnosed multiple myeloma (EMN02/HO95']","['VMP or single or double HSCT', 'prednisone', 'autologous HSCT after high-dose melphalan', 'lenalidomide', 'dexamethasone', 'bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy', 'melphalan', 'consolidation therapy with bortezomib', 'lenalidomide maintenance therapy', 'autologous HSCT', 'VMP', 'bortezomib', 'L or urine M protein', 'Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy', 'autologous haematopoietic stem-cell transplantation (HSCT', 'autologous HSCT with bortezomib-melphalan-prednisone (VMP']","['median progression-free survival', 'neutropenia', 'progression-free survival', 'number of events of progression or death at data cutoff', 'gastrointestinal disorders', 'cardiac events', 'serious adverse event', 'thrombocytopenia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",1503.0,0.203417,Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gay', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Oliva', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Vincent H J', 'Initials': 'VHJ', 'LastName': 'van der Velden', 'Affiliation': 'Department of Immunology, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giuseppe A', 'Initials': 'GA', 'LastName': 'Palumbo', 'Affiliation': 'Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate ""GF Ingrassia"", Università degli Studi di Catania, Catania, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Hematology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maisnar', 'Affiliation': '4th Department of Internal Medicine-Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamberi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Belotti', 'Affiliation': 'SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ypma', 'Affiliation': 'Department of Hematology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Alexsandra', 'Initials': 'A', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': 'Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Offidani', 'Affiliation': 'Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.'}, {'ForeName': 'Iolanda D', 'Initials': 'ID', 'LastName': 'Vincelli', 'Affiliation': 'Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Zambello', 'Affiliation': 'Hematology, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.'}, {'ForeName': 'Niels Frost', 'Initials': 'NF', 'LastName': 'Andersen', 'Affiliation': 'Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Troia', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pascarella', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Benevolo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': 'Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Morelli', 'Affiliation': 'Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, ""Spirito Santo"" Civic Hospital, Pescara, Italy.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'von dem Borne', 'Affiliation': 'Department of Hematology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Caravita di Toritto', 'Affiliation': 'UOSD Ematologia ASL Roma 1, Rome, Italy.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Zander', 'Affiliation': 'Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Hematology, University Aldo Moro, Bari, Italy.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Kliniek, Zwolle, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mandigers', 'Affiliation': 'Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cafro', 'Affiliation': 'Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Palmas', 'Affiliation': 'Haematology, Ospedale San Francesco, Nuoro, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Haematology, Alfred Hospital-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30099-5'] 68,32365607,Effectiveness of a Teacher Training Program for Students with Symptoms of Developmental Disorders: Data from a Correspondence High School in Japan.,"In the present study, a teacher training program based on behavioral therapy was conducted for high school correspondence course teachers of adolescents aged between 15 and 18 years who showed developmental difficulties. Participating teachers were assigned to either an immediate treatment (IT; n = 13) or delayed treatment control (DTC; n = 17) group to evaluate the effectiveness of the program, which comprised five 90-min sessions with small groups of three to six participants and was conducted over three months. The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement. We discuss the program's feasibility in terms of developing support resources for teachers in Japanese high schools.",2020,"The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement.","['Students with Symptoms of Developmental Disorders', 'teachers in Japanese high schools', 'high school correspondence course teachers of adolescents aged between 15 and 18 years who showed developmental difficulties']","['teacher training program based on behavioral therapy', 'Teacher Training Program', 'immediate treatment (IT; n = 13) or delayed treatment control (DTC']","[""students' behaviors and social responsiveness and in teachers' confidence""]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010104', 'cui_str': 'Correspondence Courses'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3693346', 'cui_str': 'Treatment Delay'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012194', 'cui_str': 'Dithiocarb'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0115432,"The results showed significant improvement in students' behaviors and social responsiveness and in teachers' confidence among those in the IT group; however, those in the DTC group did not show any such improvement.","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okuno', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Nakaoka', 'Affiliation': 'Clark Memorial International High School, Hyogo 669-1512, Japan.'}, {'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Iwasaka', 'Affiliation': 'Developmental Center for Child and Adult, Shigisan Hospital, Nara 636-0815, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'United Graduate School of Child Development, Osaka University, Osaka 565-0871, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17093100'] 69,32365613,Multi-System Physical Exercise Intervention for Fall Prevention and Quality of Life in Pre-Frail Older Adults: A Randomized Controlled Trial.,"Effective interventions for indicated fall prevention are necessary for older adults with frailty. We aimed to determine the effectiveness of a Multi-system Physical Exercise (MPE) for fall prevention and Health-Related Quality of Life (HRQOL) in pre-frail older adults. This randomized control trial with allocation concealment included 72 adults aged 65 and above, identified as pre-frailty and with mild and moderate fall risk scores measured by the Physiological Profile Assessment (PPA). Randomly, using block randomization, participants were divided into two groups: an MPE group (n = 36) and a control group (n = 36). The intervention consisted mainly of proprioception, muscle strengthening, reaction time, and balance training and was carried out three days per week for 12 weeks. The primary outcome was fall risk assessed using PPA at 12 weeks post-baseline and at a 24 week follow-up. Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24. In addition, HRQOL had increased significantly in the MPE group in comparison to controls. The MPE program significantly increased muscle strength and improved proprioception, reaction time, and postural sway leading to fall risk reduction in older adults with pre-frailty. Therefore, the MPE program is recommended for used in day-to-day primary care practice in the pre-frail population.",2020,"Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24.","['older adults with frailty', 'older adults with pre-frailty', '72 adults aged 65 and above, identified as pre-frailty and with mild and moderate fall risk scores measured by the Physiological Profile Assessment (PPA', 'Pre-Frail Older Adults', 'pre-frail older adults']","['MPE', 'Multi-system Physical Exercise (MPE', 'intervention consisted mainly of proprioception, muscle strengthening, reaction time, and balance training', 'Multi-System Physical Exercise Intervention']","['fall prevention and Health-Related Quality of Life (HRQOL', 'HRQOL', 'fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores', 'muscle strength and improved proprioception, reaction time, and postural sway leading to fall risk reduction', 'fall risk assessed using PPA', 'Fall Prevention and Quality of Life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",72.0,0.0349773,"Significant differences were found in the improvement in fall risk, proprioception, muscle strength, reaction time and postural sway, and fear of fall scores in the MPE group compared with controls at week 12 and 24.","[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Chittrakul', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Sapbamrer', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17093102'] 70,32360399,Effect of different exercise training intensities on musculoskeletal and neuropathic pain in inactive individuals with type 2 diabetes - Preliminary randomised controlled trial.,"AIMS People with type 2 diabetes (T2D) have a greater prevalence of musculoskeletal and neuropathic pain. This exploratory analysis investigated whether exercise of different intensities leads to changes in self-reported musculoskeletal pain or symptoms of diabetic neuropathy in inactive individuals with type 2 diabetes. METHODS Thirty-two inactive adults with T2D (59% male, mean age 58.7 ± 9.1yrs, median HbA 1c 7.8%) were randomised to usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT). At baseline and 8-weeks, musculoskeletal and neuropathic pain were evaluated using a modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively. Quantitative sensory testing was used to determine thermal, mechanical and vibration detection thresholds, as well as pain pressure thresholds. Adverse events were recorded throughout the intervention. RESULTS Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [-10.6 to -0.2], p = 0.04) and non-significantly greater for C-MICT (MD -5.9 [-12.4 to 0.7], p = 0.08). Changes in neuropathy symptoms were not different between C-HIIT and CON (MD 1.0 [-0.9 to 2.8], p = 0.31), or C-MICT and CON (MD 0.2 [-3.1 to 3.6], p = 0.89). No differences in sensory function were observed between groups. Similar rates of adverse events were seen in both exercise interventions (19 C-HIIT; 17 C-MICT), all but one of which were mild. CONCLUSIONS Preliminary data suggests 8-weeks of high-intensity combined aerobic and resistance exercise may be safely prescribed for inactive individuals with T2D and may reduce musculoskeletal pain but not neuropathic symptoms. TRIAL REGISTRATION ACTRN12615000475549.",2020,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","['inactive individuals with type 2 diabetes', 'Thirty-two inactive adults with T2D (59% male, mean age 58.7±9.1yrs, median HbA 1c 7.8', 'People with type 2 diabetes (T2D', 'Inactive Individuals with Type 2 Diabetes']","['usual care (CON), supervised combined aerobic and resistance moderate-intensity continuous training (C-MICT), or supervised combined high-intensity interval training (C-HIIT', 'CON', 'Different Exercise Training Intensities']","['modified Nordic Musculoskeletal Questionnaire and the Neuropathy Total Symptom Score-6 respectively', 'sensory function', 'Adverse events', 'Musculoskeletal and Neuropathic Pain', 'musculoskeletal pain intensity', 'neuropathy symptoms', 'adverse events', 'pain pressure thresholds', 'musculoskeletal and neuropathic pain', 'musculoskeletal pain']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",32.0,0.143575,"Compared to CON, reduction in musculoskeletal pain intensity was significantly greater for C-HIIT (MD -5.4, 95% CI [","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Cox', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trishan', 'Initials': 'T', 'LastName': 'Gajanand', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Nicola W', 'Initials': 'NW', 'LastName': 'Burton', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Brooke K', 'Initials': 'BK', 'LastName': 'Coombes', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Nathan, Queensland, Australia. Electronic address: b.coombes@griffith.edu.au.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108168'] 71,32360596,What factors modify the effect of monthly bolus dose vitamin D supplementation on 25-hydroxyvitamin D concentrations?,"The increasing use of vitamin D supplements has stimulated interest in identifying factors that may modify the effect of supplementation on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. Such information is of potential interest to researchers, clinicians and patients when deciding on bolus dose of vitamin D supplementation. We carried out a large randomized controlled trial of 5110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity, to whom we gave a standard dose of vitamin D 3 supplements (200,000 IU initially, then 100,000 IU monthly) which was taken with high adherence. All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study. Serum 25(OH)D was measured by LC/MSMS. Mixed model analyses were carried out on all 854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal.D.Forte tablets), asthma/COPD and the study treatment (vitamin D or placebo). The adjusted mean difference in 25(OH)D in the follow-up points between vitamin D supplementation and placebo groups was inversely related (all p for interaction <0.05) to baseline 25(OH)D, BMI, and hours of sun exposure, and higher in females, elders, and those with high frequency of alcohol, medical prescription of vitamin D, and asthma/COPD. The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33). In summary, these data show that vitamin D status, BMI, sun exposure hours, sex and asthma/COPD modify the 25(OH)D response to vitamin D supplementation. By contrast, ethnicity, tobacco smoking, and vigorous activity do not.",2020,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","['5,110 adults aged 50-84 years, of European/Other (84%), Polynesian (11%) and Asian (5%) ethnicity', 'All participants provided a baseline blood sample, and follow-up blood samples were collected at 6 months and annually for 3 years in a random sample of 441 participants, and also at 2 years in 413 participants enrolled in a bone density sub-study', '854 participants providing follow-up blood samples in multivariable models that included age, sex, ethnicity, body mass index (kg/m 2 ), tobacco smoking, alcohol intake, physical activity, sun exposure, season, medical prescription of high-dose vitamin D 3 (Cal']","['vitamin D supplements', 'vitamin D 3 supplements', 'vitamin D or placebo', 'vitamin D supplementation', 'placebo']","['vigorous activity', 'circulating 25-hydroxyvitamin D (25(OH)D) concentrations', 'baseline 25(OH)D, BMI, and hours of sun exposure', 'Serum 25(OH)D', '25-hydroxyvitamin D concentrations', 'vitamin D status, BMI, sun exposure hours, sex and asthma/COPD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0240790', 'cui_str': 'Polynesians'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",5110.0,0.281124,"The mean difference was not significantly related to ethnicity (p = 0.12), tobacco (p = 0.34), and vigorous activity (p = 0.33).","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Beros', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlene M M', 'Initials': 'CMM', 'LastName': 'Lawes', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Toop', 'Affiliation': 'Department of Public Health & General Practice, The University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Department of Public Health, University of Cambridge, Cambridge, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105687'] 72,32370202,Outcome Expectations for Exercise and Decisional Balance Questionnaires Predict Adherence and Efficacy of Exercise Programs in Dialysis Patients.,"The purpose of this study was to define if Outcomes Expectations for Exercise (OEE) and Decisional Balance (DB) scales predict adherence to guided exercise programs and associate with the improvement in physical performance in the dialysis population. Participants ( n = 40; age 63.6 ± 12.5 years) completed OEE and DB questionnaires before randomization to the experimental group ( n = 20) and control group ( n = 20) of a two-phased exercise program-the experimental group received eight weeks of supervised functional exercise and exercise counseling (1st phase) before commencing eight weeks of home-based exercise on non-dialysis days (2nd phase). Both groups performed intradialytic cycling on dialysis days during both study phases. Patients with above-median OEE and DB scores (>3.15 and >1.3, respectively) expressed significantly better adherence to intradialytic cycling (89% vs. 76%, 89% vs. 77%, respectively, p < 0.05). Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05). Baseline DB score predicted the final result in the hand-grip test and 6-min walk test. Low OEE and, to a lesser degree, low DB questionnaire scores associate with inferior adherence to dialysis bundled and home-based exercise programs and may help define patient subsets in need of intensified motivational input by exercise caregivers.",2020,"Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05).","['Participants ( n = 40; age 63.6 ± 12.5 years) completed OEE and DB questionnaires before randomization to the experimental group ( n = 20) and control group ( n = 20) of a', 'dialysis population', 'Dialysis Patients']",['two-phased exercise program-the experimental group received eight weeks of supervised functional exercise and exercise counseling (1st phase) before commencing eight weeks of home-based exercise'],"['Baseline DB score', 'DB scores', 'adherence to supervised and home-based functional exercise', 'low DB questionnaire scores', 'physical performance', 'adherence to intradialytic cycling']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0311714,"Experimental group patients with an above-median OEE (but not DB) score had significantly better adherence to supervised and home-based functional exercise (93% vs. 81% and 85% vs. 60%, respectively, p < 0.05).","[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Buturović Ponikvar', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17093175'] 73,32370544,A randomized controlled trial of high-intensity interval training and inspiratory muscle training for chronic heart failure patients with inspiratory muscle weakness.,"OBJECTIVES Chronic heart failure is a major public health problem in which supervised exercise programs are recommended as part of non-pharmacological management. There are various reports of the success of high-intensity aerobic interval training (HI-AIT) and inspiratory muscle training (IMT) in the management of chronic heart failure patients. This study tested the hypothesis that the combination of HI-AIT and IMT could result in additional benefits over the IMT and the HI-AIT alone in terms of inspiratory muscle function, exercise capacity, and quality of life in patients with chronic heart failure and inspiratory muscle weakness. METHODS Forty patients with ejection fraction ≤45% and inspiratory muscle weakness described by maximal inspiratory pressure <70% predicted, underwent three exercise training sessions per week for 12 weeks. Patients were randomly allocated to one of four groups: the HI-AIT group, the IMT group, the combined (HI-AIT & IMT) group, and the control group. Before and after completing their training period, all patients underwent different tests that are mentioned above. RESULTS No changes were detected in the control group. However, the combined group, when compared to HI-AIT and IMT groups, respectively, resulted in additional significant improvement in maximal inspiratory training (62%, 24%, 25%), exercise time (62%, 29%, 12%), the 6-minute walk test (23%, 15%, 18%), and the Minnesota Living with Heart Failure Questionnaire (56%, 47%, 36%). CONCLUSION In patients with chronic heart failure and inspiratory muscle weakness, the combination of the HI-AIT and the IMT resulted in additional benefits in respiratory muscle function, exercise performance, and quality of life compared to that of HI-AIT or IMT alone. Trial Registration number : NCT03538249.",2020,No changes were detected in the control group.,"['chronic heart failure patients', 'patients with chronic heart failure and inspiratory muscle weakness', 'Forty patients with ejection fraction ≤45% and inspiratory muscle weakness described by maximal inspiratory pressure <70% predicted, underwent three', 'chronic heart failure patients with inspiratory muscle weakness']","['IMT group, the combined (HI-AIT & IMT', 'exercise training sessions', 'high-intensity interval training and inspiratory muscle training', 'HI-AIT and IMT', 'intensity aerobic interval training (HI-AIT) and inspiratory muscle training (IMT', 'IMT']","['maximal inspiratory training', 'exercise time', '6-minute walk test', 'Minnesota Living with Heart Failure Questionnaire', 'inspiratory muscle function, exercise capacity, and quality of life', 'respiratory muscle function, exercise performance, and quality of life']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",40.0,0.0312952,No changes were detected in the control group.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sadek', 'Affiliation': ""Laboratory EA-3300 (APERE) « Adaptations Physiologiques à l'Exercice et Réadaptation à l'Effort », Picardie Jules Verne University, Amiens, France.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salami', 'Affiliation': 'Rammal Hassan Rammal Research Laboratory, Physio-toxicity (PhyTox) Research Group, Faculty of Sciences (V), Lebanese University, Nabatieh, Lebanon.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Youness', 'Affiliation': 'Medical Research Center of Beirut Cardiac Institute, Beirut, Lebanon.'}, {'ForeName': 'Charifa', 'Initials': 'C', 'LastName': 'Awada', 'Affiliation': 'Rammal Hassan Rammal Research Laboratory, Physio-toxicity (PhyTox) Research Group, Faculty of Sciences (V), Lebanese University, Nabatieh, Lebanon.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Hamade', 'Affiliation': 'Medical Research Center of Beirut Cardiac Institute, Beirut, Lebanon.'}, {'ForeName': 'Wissam H', 'Initials': 'WH', 'LastName': 'Joumaa', 'Affiliation': 'Rammal Hassan Rammal Research Laboratory, Physio-toxicity (PhyTox) Research Group, Faculty of Sciences (V), Lebanese University, Nabatieh, Lebanon.'}, {'ForeName': 'Wiam', 'Initials': 'W', 'LastName': 'Ramadan', 'Affiliation': 'Rammal Hassan Rammal Research Laboratory, Physio-toxicity (PhyTox) Research Group, Faculty of Sciences (V), Lebanese University, Nabatieh, Lebanon.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Ahmaidi', 'Affiliation': ""Laboratory EA-3300 (APERE) « Adaptations Physiologiques à l'Exercice et Réadaptation à l'Effort », Picardie Jules Verne University, Amiens, France.""}]",Chronic illness,['10.1177/1742395320920700'] 74,32372433,"Re: Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial.",,2020,,['early-onset pre-eclampsia'],"['Re: Pravastatin', 'placebo']",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.772416,,"[{'ForeName': 'Liliana S', 'Initials': 'LS', 'LastName': 'Voto', 'Affiliation': 'Departamento Materno infantil, Hospital General de Agudos Dr. Juan A. Fernández, Ciudad de Buenos Aires, Argentina.'}, {'ForeName': 'Moises G', 'Initials': 'MG', 'LastName': 'Zeitune', 'Affiliation': 'Departamento Materno infantil, Hospital General de Agudos Dr. Juan A. Fernández, Ciudad de Buenos Aires, Argentina.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16240'] 75,32371123,Health-related quality of life after chemotherapy with or without rituximab in primary central nervous system lymphoma patients: results from a randomised phase III study.,"BACKGROUND The impact of rituximab on health-related quality of life (HRQoL) in primary central nervous system lymphoma patients is not well known. We determined the impact of rituximab added to standard high-dose methotrexate-based treatment on HRQoL in patients in a large randomised trial. PATIENTS AND METHODS Patients from a large phase III trial (HOVON 105/ALLG NHL 24), randomly assigned to receive standard chemotherapy with or without rituximab and followed by 30 Gy whole brain radiotherapy (WBRT) in patients ≤60 years, completed the EORTC QLQ-C30 and QLQ-BN20 questionnaires before and during treatment, and up to 24 months of follow-up or progression. Differences between treatment arms over time in global health status, role functioning, social functioning, fatigue, and motor dysfunction were assessed. Differences ≥10 points were deemed clinically relevant. The effect of WBRT on HRQoL was analysed in irradiated patients. RESULTS A total of 160/175 patients eligible for the HRQoL study completed at least one questionnaire and were included. Over time, scores improved statistically significantly and were clinically relevant in both arms. Between arms, there were no differences on any scale (range: -3.8 to +4.0). Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared with baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively). In irradiated patients (n = 59), scores in all preselected scales, except motor dysfunction, remained stable up to 24 months compared with shortly after WBRT, overall mean difference ranging between 0.02 and 4.570. CONCLUSION Compared with baseline, treatment resulted in improved HRQoL scores. The addition of rituximab to standard chemotherapy did not impact HRQoL over time. WBRT did not result in deterioration of HRQoL in the first 2 years.",2020,"Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared to baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively).","['160/175 patients eligible for the HRQoL study completed at least one questionnaire and were included', 'Patients from a large phase III trial (HOVON 105/ALLG NHL 24', 'irradiated patients', 'primary central nervous system lymphoma patients']","['standard chemotherapy with or without rituximab and followed by 30Gy whole brain radiotherapy (WBRT', 'chemotherapy with or without rituximab', 'rituximab to standard chemotherapy', 'rituximab', 'WBRT', 'rituximab added to standard high-dose methotrexate-based treatment']","['health-related quality of life (HRQoL', 'fatigue and motor dysfunction', 'HRQoL', 'global health status, role functioning, social functioning, fatigue, and motor dysfunction', 'HRQoL scores', 'deterioration of HRQoL', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.17791,"Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared to baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Meulen', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands. Electronic address: m.vandermeulen.2@erasmusmc.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, Australia; University of Western Australia, Crawley, Australia.'}, {'ForeName': 'W B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Baars', 'Affiliation': 'Department of Hemato-Oncology, Antoni van Leeuwenhoek Hospital/Dutch Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Mason', 'Affiliation': 'Department of Hematology, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beijert', 'Affiliation': 'Department of Radiotherapy, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M J B', 'Initials': 'MJB', 'LastName': 'Taphoorn', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'J E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirven', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.014'] 76,32378975,Effect of neuromuscular electrical stimulation on skeletal muscle size and function in patients with breast cancer receiving chemotherapy.,"Exercise has numerous benefits for patients with cancer, but implementation is challenging because of practical and logistical hurdles. This study examined whether neuromuscular electrical stimulation (NMES) can serve as a surrogate for classic exercise by eliciting an exercise training response in skeletal muscle of women diagnosed with breast cancer undergoing chemotherapy. Patients ( n = 22) with histologically confirmed stage I, II, or III breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy were randomized to 8 wk of bilateral neuromuscular electrical stimulation (NMES; 5 days/wk) to their quadriceps muscles or control. Biopsy of the vastus lateralis was performed at baseline and after 8 wk of intervention to assess muscle fiber size, contractility, and mitochondrial content. Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses. NMES promoted muscle fiber hypertrophy ( P < 0.001), particularly in fast-twitch, myosin heavy chain (MHC) IIA fibers ( P < 0.05) and tended to induce fiber type shifts in MHC II fibers. The effects of NMES on single-muscle fiber contractility were modest, and it was unable to prevent declines in the function in MHC IIA fibers. NMES did not alter intermyofibrillar mitochondrial content/structure but was associated with reductions in subsarcolemmal mitochondria. Our results demonstrate that NMES induces muscle fiber hypertrophy and fiber type shifts in MHC II fibers but had minimal effects on fiber contractility and promoted reductions in subsarcolemmal mitochondria. Further studies are warranted to evaluate the utility of NMES as an exercise surrogate in cancer patients and other conditions. NEW & NOTEWORTHY This is the first study to evaluate whether neuromuscular electrical stimulation (NMES) can be used as an exercise surrogate to improve skeletal muscle fiber size or function in cancer patients receiving treatment. We show that NMES promoted muscle fiber hypertrophy and fiber type shifts but had minimal effects on single-fiber contractility and reduced subsarcolemmal mitochondria.",2020,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","['patients with cancer', 'Seventeen patients (8 control/9 NMES) completed the trial and were included in analyses', 'Patients (n=22) with histologically-confirmed, stage I, II or III breast cancer scheduled to receive', 'women diagnosed with breast cancer undergoing chemotherapy', 'patients with breast cancer receiving chemotherapy']","['neuromuscular electrical stimulation', 'NMES', 'neuromuscular electrical stimulation (NMES', 'neoadjuvant or adjuvant chemotherapy', 'bilateral neuromuscular electrical stimulation (NMES; 5 days/week) to their quadriceps muscles or control', 'Exercise']","['fast-twitch, myosin heavy chain (MHC', 'skeletal muscle size and function', 'muscle fiber hypertrophy', 'subsarcolemmal mitochondria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0333759', 'cui_str': 'Muscle fiber hypertrophy'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}]",22.0,0.0485888,"NMES promoted muscle fiber hypertrophy (P<0.001), particularly in fast-twitch, myosin heavy chain (MHC)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopedics and Rehabilitation, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Prior', 'Affiliation': 'Vermont Cancer Center, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Blas A', 'Initials': 'BA', 'LastName': 'Guigni', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Axel V', 'Initials': 'AV', 'LastName': 'Schlosberg', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Isaac B', 'Initials': 'IB', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Taylor J', 'Initials': 'TJ', 'LastName': 'Forest', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Wood', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Hibba', 'Initials': 'H', 'LastName': 'Rehman', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00203.2020'] 77,32379976,The Benefits of T'ai Chi for Older Adults with Chronic Back Pain: A Qualitative Study.,"Objective: To determine the perceived benefits of t'ai chi in older adults with chronic low-back pain (cLBP). Design: A qualitative analysis from a randomized controlled feasibility trial. Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity. Intervention: A 36-week intervention beginning with twice weekly classes for 12 weeks, weekly classes for 6 weeks, biweekly classes for 6 weeks, and monthly classes for 12 weeks. Participants were asked to practice at home on nonclass days and videos were provided to assist in that process. Outcome Measures: Participants in the focus groups were asked to provide feedback on their experiences with the study as well as the benefits of their t'ai chi practice. We used demographic and class attendance data to describe the sample. Results: Regarding the benefits of t'ai chi practice, five major themes were identified: functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi , and the integration of t'ai chi into daily activities. The most common functional benefits were improvements in balance, flexibility, leg strength, and posture. Some reported pain reduction or pain relief, but others did not. Increased relaxation, mindfulness, and a sense of connectedness were subthemes that emerged from psychospiritual benefits. Social support benefits included motivation to attend class and group support while learning a new skill. Finally, improved body awareness allowed participants to integrate t'ai chi skills into their daily activities. Conclusions: This qualitative analysis demonstrates the multifaceted benefits of t'ai chi for older adults living with cLBP.",2020,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","['Subjects: Eighteen participants (65+ years old) with cLBP of at least moderate intensity', 'older adults living with cLBP', 'older adults with chronic low-back pain (cLBP', 'Older Adults with Chronic Back Pain']","[""T'ai Chi"", ""t'ai chi practice""]","['pain reduction or pain relief', ""functional benefits, pain reduction/pain relief, psychospiritual benefits, the importance of social support in learning t'ai chi , and the integration of t'ai chi into daily activities"", 'balance, flexibility, leg strength, and posture']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",,0.0522767,"The most common functional benefits were improvements in balance, flexibility, leg strength, and posture.","[{'ForeName': 'Tamsin L', 'Initials': 'TL', 'LastName': 'Lee', 'Affiliation': 'Department of Child, Family and Population Health Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'Hawkes', 'Affiliation': 'Kaiser Permanente WA Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Phelan', 'Affiliation': 'Department of Medicine and Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0455'] 78,32386922,Stability of acute responses to drugs in humans across repeated testing: Findings with alcohol and amphetamine.,"BACKGROUND Controlled drug challenge studies provide valuable information about the acute behavioral effects of drugs, including individual differences that may affect risk for abuse. One question that arises in such studies is whether a single administration of a drug (and placebo) provides an accurate measure of response to the drug. METHODS Here, we examined data from two studies, one with alcohol and one with amphetamine, in which participants received two administrations of the drug and placebo. In this analysis we assess the stability of acute subjective and cardiovascular responses to the drugs across the two administrations. We examine i) systematic increases or decreases to the drugs from the first to the second administration, ii) test-retest reliability within individuals and iii) the accuracy of the acute drug responses to predict drug choice in a later session. RESULTS Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies. Test-retest reliability within individuals was high. Responses during the first drug administration were as accurate in predicting drug choice as responses during both administrations combined. CONCLUSIONS Our findings indicate that a single administration of drug (and placebo) provides a good index of an individual's responses to alcohol or amphetamine, when participants are tested under controlled experimental conditions.",2020,"RESULTS Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.",[],"['drug (and placebo', 'amphetamine', 'placebo']",['stability of acute subjective and cardiovascular responses'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0465427,"RESULTS Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA. Electronic address: hdew@uchicago.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107989'] 79,32388198,Cost-Effectiveness Analysis of Xpert MTB/RIF for Multi-Outcomes of Patients With Presumptive Pulmonary Tuberculosis in Thailand.,"OBJECTIVES The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs). METHODS A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing. RESULTS The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant. CONCLUSIONS These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis.",2020,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"['Presumptive Pulmonary Tuberculosis Patients in Thailand', 'adult patients for pulmonary tuberculosis']","['Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear', 'Xpert MTB/RIF']","['total cost', 'correct diagnosis', 'quality of life (EQ-5D-5L', 'cost-effectiveness', 'correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs']","[{'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1318720', 'cui_str': 'Acid fast stain'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0222549,The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear.,"[{'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Khumsri', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Department of Preventive and Social Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Hanvoravongchai', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand; Thailand Research Center for Health Services System, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Hiransuthikul', 'Affiliation': 'Department of Medical Services, Nopparat Rajathanee Hospital, Ministry of Public Health, Bangkok, Thailand. Electronic address: nhiransu@yahoo.com.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Chuchottaworn', 'Affiliation': 'Department of Medical Services, Central Chest Institute of Thailand, Ministry of Public Health, Nonthaburi, Thailand.'}]",Value in health regional issues,['10.1016/j.vhri.2019.09.010'] 80,32356586,Efficacy of oral methotrexate (MTX) monotherapy vs oral MTX plus narrowband ultraviolet light B phototherapy in palmoplantar psoriasis.,"Palmoplantar psoriasis (PPP) is a chronic, inflammatory dermatosis of the palms and/or soles with significant morbidity. It is notoriously difficult to treat and unresponsive to traditional topical agents. We aim to compare the effect of oral methotrexate (MTX) monotherapy vs MTX plus narrowband ultraviolet light B (NB-UVB) in the treatment of recalcitrant PPP. This was a comparative clinical trial involving 90 patients of PPP. Eligible patients were randomly assigned to one of the two treatment groups. We aim patients in group A received 10 mg oral MTX weekly, and patients in group B received oral MTX 10 mg weekly and NB-UVB sessions twice weekly for 12 weeks. There was a statistically significant difference in reduction of modified PPP Area Severity Index (m-PPPASI) of patients in MTX plus NB-UVB at week 12. The mean m-PPPASI at week 12 was 3.66 ± 2.11 in MTX plus NB-UVB group and 6.51 ± 2.04 in MTX only group (P < .001). Marked improvement (m-PPPASI 75) was achieved in 20 (44.44%) patients in MTX plus NB-UVB group compared with 6 (13.3%) in MTX monotherapy group (P < .001). Combination of MTX and NB-UVB phototherapy helps to attain a better clinical response (reduction in m-PPPASI score) than MTX monotherapy in the treatment of recalcitrant PPP.",2020,There was a statistically significant difference in reduction of m-PPPASI of patients in MTX plus NB-UVB at weeks 12.,"['90 patients of PPP', 'Eligible patients', 'palmo plantar psoriasis']","['oral Methotrexate (MTX) monotherapy vs Methotrexate plus Narrowband UVB (NB-UVB', 'oral methotrexate monotherapy vs oral methotrexate plus narrow band UV-B phototherapy', 'MTX and NB-UVB phototherapy', 'MTX', '10\xa0mg oral MTX', 'MTX monotherapy', 'oral MTX 10\xa0mg weekly and NB-UVB sessions']","['Palmoplantar psoriasis (PPP', 'mean m-PPPASI', 'reduction of m-PPPASI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C3472306', 'cui_str': 'Narrowband ultraviolet B phototherapy'}, {'cui': 'C1127564', 'cui_str': 'Methotrexate 10 MG'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0031106', 'cui_str': 'Aggressive periodontitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",90.0,0.0720912,There was a statistically significant difference in reduction of m-PPPASI of patients in MTX plus NB-UVB at weeks 12.,"[{'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Ara', 'Affiliation': 'Department of Dermatology and Venereology, Chittagong International Medical College, Chittagong, Bangladesh.'}, {'ForeName': 'Mohammad Rafiqul', 'Initials': 'MR', 'LastName': 'Mowla', 'Affiliation': 'Department of Dermatology and Venereology, Chittagong Medical College, Chittagong, Bangladesh.'}, {'ForeName': 'Mansurul', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': ""Department of Dermatology and Venereology, Cox's Bazar Medical College, Cox's Bazar, Bangladesh.""}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Department of Pharmacology, Chittagong Medical University, Chittagong, Bangladesh.'}]",Dermatologic therapy,['10.1111/dth.13486'] 81,32358259,Evaluation of total corneal power measurements with a new optical biometer.,"PURPOSE To evaluate the repeatability and validity of total corneal power measurements (total keratometry [TK]) obtained with a recently introduced optical biometer (IOLMaster 700, Carl Zeiss Meditec AG) to a Scheimpflug device (Pentacam, Oculus). SETTING Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany. DESIGN Prospective randomized controlled trial. METHODS The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes. All eyes were measured 3 times using the optical biometer and the Scheimpflug device. The results were statistically compared using Bland-Altman, within-subject SD, and astigmatism vector analysis. RESULTS Ninety-three eyes of 93 subjects were included. Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case. A difference of >0.50 diopters between astigmatism measurements between TK and TCRP was found in 10 cases compared with standard K and TNP with 0 and 2 cases. CONCLUSIONS Repeatability of both devices was high, although measurements of meridian showed a great variability, suggesting that numerous measurements are needed to enhance accuracy. TCRP measurements between recently introduced TK and TCRP cannot be used interchangeably. Future studies are necessary to evaluate which measurement will result in a better outcome when respective measurements are used for toric intraocular lens calculations.",2020,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","['Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany', 'The inclusion criteria were a corneal astigmatism of 3.00 diopters (D) or less, no previous ocular surgery, no known corneal irregularities, and no known dry eyes', 'Ninety-three eyes of 93 subjects were included']",['total corneal power measurements (total keratometry [TK'],"['total corneal refractive power (TCRP', 'TCRP measurements']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0024081', 'cui_str': ""Ludwig's angina""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429520', 'cui_str': 'Refractive power'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",93.0,0.0716156,"Overall, the repeatability of all eyes measured was 0.42 for standard K, 0.40 for TK, 0.45 for total corneal refractive power (TCRP), 0.43 for true net power (TNP), and 0.39 for simulated K. Bland-Altman analysis showed no significant difference between the optical biometer's TK compared with standard K and the Scheimpflug device's simulated K, TNP, and TCRP, the P value exceeding .05 in each case.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Shajari', 'Affiliation': 'From the Department of Ophthalmology, Ludwig-Maximilians University (Shajari, Sonntag, Ramsauer, Kreutzer, Vounotrypidis, Priglinger, Mayer), Munich, Department of Ophthalmology (Shajari, Kohnen), Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Ruven', 'Initials': 'R', 'LastName': 'Sonntag', 'Affiliation': ''}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Ramsauer', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kreutzer', 'Affiliation': ''}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Vounotrypidis', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohnen', 'Affiliation': ''}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Priglinger', 'Affiliation': ''}, {'ForeName': 'Wolfgang J', 'Initials': 'WJ', 'LastName': 'Mayer', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000136'] 82,32370148,When a Combination of Nudges Decreases Sustainable Food Choices Out-Of-Home-The Example of Food Decoys and Descriptive Name Labels.,"This paper reports results from three consecutive studies focusing on the comparison of the effectiveness of different nudges and their combinations to increase sustainable food choices out of the home. The nudges compared are the use of descriptive name labels (DNLs) for the most sustainable dish of a choice set (menu) and the decoy effect (DE), created by adding a less attractive decoy dish to a more attractive target dish with the goal of increasing the choice frequency of the target dish. In the literature, both nudges have been found to influence consumers' choices. In the first study, six category names of sustainability indicators were deduced from a focus group. These were tested with 100 students to identify the most attractive DNLs. Study II, a randomized choice study ( n = 420), tested the DE, the DNLs and a combination of the DNLs and the DE used on four different dishes in a university canteen. In study III, 820 guests of a business canteen voted during four weeks for the special meals of the following week (identical to the four choice sets displayed in study II). Results indicate that the combination of DNLs and the DE is not recommended for fostering sustainable food choices. Pure DNLs were more efficient in increasing the choice frequency of the more sustainable meal, whereas the decoy effect resulted in decreased choice frequencies. Regional and sustainable DNLs were favoured by consumers.",2020,"Pure DNLs were more efficient in increasing the choice frequency of the more sustainable meal, whereas the decoy effect resulted in decreased choice frequencies.",['100 students to identify the most attractive DNLs'],[],['Sustainable Food Choices'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0240182,"Pure DNLs were more efficient in increasing the choice frequency of the more sustainable meal, whereas the decoy effect resulted in decreased choice frequencies.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Ohlhausen', 'Affiliation': 'Institute of Vocational Education and Work Studies, Department Education for Sustainable Nutrition and Food Science, Technische Universität Berlin, 10587 Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Langen', 'Affiliation': 'Institute of Vocational Education and Work Studies, Department Education for Sustainable Nutrition and Food Science, Technische Universität Berlin, 10587 Berlin, Germany.'}]","Foods (Basel, Switzerland)",['10.3390/foods9050557'] 83,32380679,"Effect of Dynamic Balance Exercises Based on Visual Feedback on Physical Function, Balance Ability, and Depression in Women after Bilateral Total Knee Arthroplasty: A Randomized Controlled Trial.","The aim of this study was to compare the effects of dynamic balance exercises with and without visual feedback on recovery from total knee arthroplasty. The participants were 30 women who underwent total knee arthroplasty more than one week before the study, and were randomly allocated into two groups. The average ages of the experimental and control groups were 70.13 and 69.00 years, respectively. The dynamic balance exercise with visual feedback (VF) group practiced dynamic balance exercises using a laser pointer for five 30-min sessions over a 4-week period. The dynamic balance exercise without visual feedback (control) group practiced dynamic balance exercises for five 30 min sessions over a 4 week period. The following clinical measures were used for assessing physical function, balance ability, and depression. Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p < 0.05). Furthermore, the VF group showed significant improvements in all post-surgery outcome measures compared with the pre-surgery values ( p < 0.05). The above results indicated that the dynamic balance exercises based on visual feedback improved physical function and balance ability in patients following total knee arthroplasty, suggesting the need for effective rehabilitation programs for patients with total knee arthroplasty.",2020,"Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p < 0.05).","['Women after Bilateral Total Knee Arthroplasty', 'total knee arthroplasty', 'participants were 30 women who underwent total knee arthroplasty more than one week before the study', 'patients with total knee arthroplasty']","['Dynamic Balance Exercises', 'dynamic balance exercise without visual feedback (control) group practiced dynamic balance exercises', 'dynamic balance exercises with and without visual feedback', 'dynamic balance exercises', 'dynamic balance exercise with visual feedback (VF) group practiced dynamic balance exercises']","['visual feedback improved physical function and balance ability', 'Physical Function, Balance Ability, and Depression', 'physical function, balance ability, and depression', 'physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",30.0,0.0218742,"Compared with the control group, the VF group showed significant improvements in the physical performance test, Western Ontario and McMaster Universities Arthritis Index (WOMAC), confidence ellipse area (CEA), path length (PL), average velocity (AV), and Timed Up and Go test (TUG test) ( p < 0.05).","[{'ForeName': 'Ju-Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Andong Science College, Andong 36616, Korea.'}, {'ForeName': 'Byoung-Hee', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul 01795, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093203'] 84,32385158,Common and dissociable effects of oxytocin and lorazepam on the neurocircuitry of fear.,"Benzodiazepines (BZDs) represent the gold standard of anxiolytic pharmacotherapy; however, their clinical benefit is limited by side effects and addictive potential. Consequently, there is an urgent need to develop novel and safe anxiolytics. The peptide hormone oxytocin (OXT) exhibits anxiolytic-like properties in animals and humans, but whether OXT and BZDs share similar effects on the neural circuitry of fear is unclear. Therefore, the rationale of this ultra-high-field functional MRI (fMRI) study was to test OXT against the clinical comparator lorazepam (LZP) with regard to their neuromodulatory effects on local and network responses to fear-related stimuli. One hundred twenty-eight healthy male participants volunteered in this randomized double-blind, placebo-controlled, between-group study. Before scanning using an emotional face-matching paradigm, participants were randomly administered a single dose of OXT (24 IU), LZP (1 mg), or placebo. On the behavioral level, LZP, but not OXT, caused mild sedation, as evidenced by a 19% increase in reaction times. On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA). In contrast, they had different effects on intra-amygdalar connectivity; OXT strengthened the coupling between the cmA and basolateral amygdala, whereas LZP increased the interplay between the cmA and superficial amygdala. Furthermore, OXT, but not LZP, enhanced the coupling between the cmA and the precuneus and dorsomedial prefrontal cortex. These data implicate inhibition of the cmA as a common denominator of anxiolytic action, with only OXT inducing large-scale connectivity changes of potential therapeutic relevance.",2020,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).",['One hundred twenty-eight healthy male participants volunteered'],"['Benzodiazepines (BZDs', 'oxytocin and lorazepam', 'OXT', 'LZP', 'peptide hormone oxytocin (OXT', 'lorazepam (LZP', 'placebo']","['neurocircuitry of fear', 'reaction times']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",128.0,0.100533,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, 35390 Giessen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, 26129 Oldenburg, Germany.'}, {'ForeName': 'Torge', 'Initials': 'T', 'LastName': 'Dellert', 'Affiliation': 'Institute of Medical Psychology and Systems Neuroscience, University of Muenster, 48149 Muenster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Babasiz', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Herscheid', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Remmersmann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Stirnberg', 'Affiliation': 'Division of MR Physics, German Center for Neurodegenerative Diseases, 53175 Bonn, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stöcker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany; renehurlemann@icloud.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920147117'] 85,32386308,Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias.,"PURPOSE Urethral fistula and dehiscence are common after hypospadias surgery. Preoperative androgens have been considered to reduce these complications although this consideration is not evidence-based. Dermatologists have reported the benefits of topical estrogens on skin healing. We investigated whether the preoperative use of topical promestriene could reduce healing complications in hypospadias surgery. Our primary objective was to demonstrate a reduction of healing complications with promestriene vs placebo. Impact on reoperations and other complications, clinical tolerance, bone growth, and biological systemic effects of the treatment were also considered. METHODS We conducted a prospective, randomized, placebo-controlled, double-blind, parallel group trial between 2011 and 2015 in 4 French centers. One-stage transverse preputial island flap urethroplasty (onlay urethroplasty) was selected for severe hypospadias. Promestriene or placebo was applied on the penis for 2 months prior to surgery. The primary outcome was the presence of postoperative urethral fistula or dehiscence in the first year postsurgery. For safety reasons, hormonal and anatomical screenings were performed. RESULTS Out of 241 patients who received surgery, 122 patients were randomized to receive placebo, and 119 patients received promestriene. The primary outcome was unavailable for 11 patients. Healing complications were assessed at 16.4% (19/116) in the placebo vs 14.9% (17/114) in the promestriene arm, and the odds ratio adjusted on center was 0.93 (95% confidence interval 0.45-1.94), P = 0.86. CONCLUSIONS AND RELEVANCE Although we observed an overall lower risk of complications compared to previous publications, postsurgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of promestriene.",2020,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","['hypospadias surgery', '241 patients who received surgery', '2011 and 2015, in 4 French centers', '122 patients', '244 children with midshaft and posterior hypospadias']","['topical Estrogens', 'topical Promestriene', 'Promestriene or placebo', 'placebo']","['healing complications', 'reoperations and other complications, clinical tolerance, bone growth and biological systemic effects', 'presence of postoperative urethral fistula or dehiscence in the first year post-surgery', 'skin healing', 'Healing complications']","[{'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0041970', 'cui_str': 'Urethral fistula'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",241.0,0.658829,"Although we observed an overall lower risk of complications compared to previous publications, post-surgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of Promestriene.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Gorduza', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Plotton', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Remontet', 'Affiliation': 'Université de Lyon, Lyon, France.'}, {'ForeName': 'Claire-Lise', 'Initials': 'CL', 'LastName': 'Gay', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'El Jani', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Cheikhelard', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blanc', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, APHP, Hôpital Necker, Paris, France; Université Sorbonne Paris cité, Paris, France.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'El Ghoneimi', 'Affiliation': 'Service de chirurgie viscérale et urologie pédiatrique, Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Hôpital Robert Debré, APHP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Marc-David', 'Initials': 'MD', 'LastName': 'Leclair', 'Affiliation': 'Service de chirurgie pédiatrique, CHU de Nantes, Nantes, Loire Atlantique, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Roy', 'Affiliation': 'Université de Lyon, Lyon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Pirot', 'Affiliation': 'Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, Lyon Cedex, France.'}, {'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Mimouni', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Segolene', 'Initials': 'S', 'LastName': 'Gaillard', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chatelain', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Morel', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Kassai', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mouriquand', 'Affiliation': ""Centre de Référence Maladies Rares Développement Génital: du Fœtus à l'Adulte, Hospices Civils de Lyon, Bron, France.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa231'] 86,32391584,Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study.,"AIM To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks' twice-daily use. MATERIALS AND METHODS In this randomized, examiner-blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n = 62) and Negative control (n = 62). Test and Positive control (n = 61) comparisons were exploratory objectives. RESULTS All groups significantly improved from baseline on both dentine hypersensitivity measures (p < .0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated. CONCLUSION While twice-daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. STUDY REGISTRATION Clinicaltrials.gov; NCT03310268.",2020,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. ",[],"['anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control', 'anhydrous stannous fluoride toothpaste']","['dentine hypersensitivity', 'tolerated', 'mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe', 'dentine hypersensitivity relief', 'dentine hypersensitivity measures', 'Schiff sensitivity scores']",[],"[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C1247980', 'cui_str': 'Sodium Fluoride Toothpaste'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1253019', 'cui_str': 'Stannous Fluoride Toothpaste'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0429399', 'cui_str': 'Tactile threshold'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.132493,"Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. ","[{'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Tao', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Ling', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}, {'ForeName': 'Xi-Ping', 'Initials': 'XP', 'LastName': 'Feng', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallob', 'Affiliation': 'Consumer Research Consulting, LLC, Las Vegas, NV, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Souverain', 'Affiliation': 'GSK Consumer Healthcare, Nyon, Switzerland.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Anousheh', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, UK.'}]",Journal of clinical periodontology,['10.1111/jcpe.13305'] 87,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial.","AIMS & OBJECTIVES The hand-sewn method of bowel anastomosis is the most common because of its affordability, familiarity and easy availability of materials. It can be done in single or double layers, with different surgeons preferring one technique over the other. Double layer intestinal anastomosis (DLIA) is time-consuming, challenging to perform, and carries possibly a higher risk of devascularisation, infection, and necrosis. Studies conducted so far do not show a significant difference between the two, but have concluded that more studies are required to determine this definitively. This study attempted to see whether the single layer intestinal anastomosis (SLIA) is non-inferior to DLIA in terms of incidence of anastomotic leak. It also compared mortality, morbidity, and length of hospitalization (LOH) between the two groups. MATERIALS AND METHODS This was a parallel arm, open labelled, non-inferiority randomized controlled trial conducted in the department of surgery in a tertiary care centre between October 2016 and March 2018. Patients who fulfilled the inclusion criteria were randomly allotted to two groups: Patients undergoing SLIA and patients undergoing DLIA. After the procedure, all patients were assessed for anastomotic leak, morbidity, mortality and LOH in the postoperative period. A 3-month follow-up period was observed for complications. RESULTS A total of 106 patients were randomised, 52 in SLIA and 54 in DLIA. Baseline demographic and clinicopathological characteristics between the two groups were comparable. The most common indication for intestinal anastomosis was ostomy closure in both groups. There was no significant difference between the two groups in terms of anastomotic leak, other complications, mortality and LOH. CONCLUSION SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066'] 88,32326727,"Effect of Yoga Therapy on Disease Activity, Inflammatory Markers, and Heart Rate Variability in Patients with Rheumatoid Arthritis.","Background: Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease. Antirheumatoid treatment reduces disease activity and inflammation, but not all patients respond to treatment. Autonomic dysfunction is common in RA leading to frequent cardiovascular complications. Yoga therapy may be useful in these patients, but there are little data on the effect of yoga on disease activity, inflammatory markers, and heart rate variability (HRV). Objectives: This study assessed the effect of 12-week yoga therapy on disease activity, inflammatory markers, and HRV in patients with RA. Materials and Methods: This randomized control trial was conducted on newly diagnosed RA patients attending outpatient services at the Department of Clinical Immunology, JIPMER. One hundred and sixty-six participants were randomized into two groups: the control group (CG) ( n  = 83) and yoga group (YG) ( n  = 83). Yoga therapy was administered to participants in the YG for 12 weeks, along with standard medical treatment. The CG received only standard medical treatment. Primary outcomes were disease activity score 28, interleukin-1α (IL-1α), IL-6, tumor necrosis factor-α (TNF-α), cortisol, and HRV parameters. All parameters were measured at baseline and after 12 weeks. Results: Disease activity significantly decreased in both groups after 12 weeks, but it was reduced more in YG, which was statistically significant ( p  < 0.05). In both YG and CG, IL-1α, IL-6, TNF-α, and cortisol decreased after 12 weeks, but IL-1α and cortisol decreased more significantly in YG than in CG. Low-frequency component expressed as normalized unit (LFnu) and the low-frequency/high-frequency (LF-HF) ratio decreased significantly, and total power and HF component expressed as normalized unit (HFnu) increased significantly in the YG compared with CG. Conclusion: Twelve-week yoga therapy, if given along with standard medical treatment, significantly reduces disease activity and improves sympathovagal balance in RA patients.",2020,"In both YG and CG, IL-1α, IL-6, TNF-α, and cortisol decreased after 12 weeks, but IL-1α and cortisol decreased more significantly in YG than in CG.","['newly diagnosed RA patients attending outpatient services at the Department of Clinical Immunology, JIPMER', 'patients with RA', 'One hundred and sixty-six participants', 'Patients with Rheumatoid Arthritis', 'RA patients']","['Yoga Therapy', 'control group (CG) ( n \u2009=\u200983) and yoga group (YG', 'yoga therapy', 'Yoga therapy']","['total power and HF component expressed as normalized unit (HFnu', 'IL-1α and cortisol', 'Disease Activity, Inflammatory Markers, and Heart Rate Variability', 'disease activity, inflammatory markers, and heart rate variability (HRV', 'Low-frequency component expressed as normalized unit (LFnu) and the low-frequency/high-frequency (LF-HF) ratio', 'disease activity and improves sympathovagal balance', 'disease activity, inflammatory markers, and HRV', 'disease activity score 28, interleukin-1α', 'disease activity and inflammation', 'Disease activity', 'CG, IL-1α, IL-6, TNF-α, and cortisol', 'IL-1α), IL-6, tumor necrosis factor-α (TNF-α), cortisol, and HRV parameters']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C1319413', 'cui_str': 'Clinical immunology'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",166.0,0.0498552,"In both YG and CG, IL-1α, IL-6, TNF-α, and cortisol decreased after 12 weeks, but IL-1α and cortisol decreased more significantly in YG than in CG.","[{'ForeName': 'Selvakumar', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Department of Physiology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Girwar Singh', 'Initials': 'GS', 'LastName': 'Gaur', 'Affiliation': 'Department of Physiology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Vir Singh', 'Initials': 'VS', 'LastName': 'Negi', 'Affiliation': 'Department of Clinical Immunology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}, {'ForeName': 'Vivek Kumar', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Department of Physiology, Government Institute of Medical Sciences, Greater Noida, India.'}, {'ForeName': 'Gopal Krushna', 'Initials': 'GK', 'LastName': 'Pal', 'Affiliation': 'Department of Physiology, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0228'] 89,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125'] 90,32395842,Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).,"AIM To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact ® ) against a silver dressing (Aquacel ® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing. DESIGN Open randomized controlled trial, with blinded endpoint. METHODS Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. DISCUSSION Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. IMPACT Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.",2020,"Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. ","['Primary Health Care and nursing homes', 'chronic venous leg ulcers', 'Patients with chronic venous leg ulcers with signs of critical colonization', '204 subjects recruited in Primary Health Care and nursing homes', ""microorganisms' colonization of vascular ulcers""]","['hydrophobic dressing', 'hydrophobic dressing (Cutimed Sorbact ® ) against a silver dressing (Aquacel ® Ag Extra', 'Hydrophobic dressings']","['sociodemographic variables, wound-related variables (area, exudate, time to healing), level of pain, adverse effects and health-related quality of life', 'health-related quality of life, level of pain and time to complete healing']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1319597', 'cui_str': 'Silver dressing'}, {'cui': 'C0967370', 'cui_str': 'Aquacel'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",204.0,0.0905079,"Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. ","[{'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Morilla-Herrera', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Morales-Asencio', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Gómez-González', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Díez-De Los Ríos', 'Affiliation': 'Distrito Sanitario Málaga - Valle del Guadalhorce, Malaga, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Lupiáñez-Pérez', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Andrade', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Aranda-Gallardo', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Moya-Suárez', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'Shakira', 'Initials': 'S', 'LastName': 'Kaknani-Uttumchandani', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'García-Mayor', 'Affiliation': 'Department of Nursing, University of Málaga, Faculty of Health Sciences, Malaga, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14412'] 91,32406265,Peer Relations and Delinquency Among Girls in Foster Care Following a Skill-Building Preventive Intervention.,"There is evidence that risk for delinquency is elevated among girls with foster care histories, and one correlate of delinquency is affiliating with peers who engage in delinquent behavior. Although intervention studies have shown positive effects of interventions that target delinquent peer affiliation on reductions in delinquency among adolescents with juvenile justice histories, the success of such interventions for younger girls in foster care, without prior involvement with juvenile justice, is unknown. We analyzed data from a randomized clinical trial of the middle school version of the Keep Safe intervention in a sample of girls in foster care ( n = 100). The intervention was delivered to girls and foster parents during the transition to middle school. Path analysis suggested a significant intervention effect on reduction in affiliation with delinquent peers at 12 months ( B = -.21). No significant mediation effects were identified. The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior. Implications for researchers and professionals who tailor and deliver evidence-based programs for girls in foster care are discussed.",2020,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","['adolescents with juvenile justice histories', 'Girls in Foster Care', 'girls with foster care histories', 'sample of girls in foster care ( n = 100']",['middle school version of the Keep Safe intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0599066,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Schweer-Collins', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Leslie D', 'Initials': 'LD', 'LastName': 'Leve', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}]",Child maltreatment,['10.1177/1077559520923033'] 92,32365601,Preschoolers Build Fundamental Motor Skills Critical to an Active Lifestyle: The All 4 Kids © Intervention Study.,"This pragmatic, real world study examined the effects of the All 4 Kids © intervention on preschoolers' mastery of movement skills and determined whether the instruction had greater impact than natural development. Methods included a quasi-experimental intervention-comparison subsample of 379 children (COMPARISON) and a pretest-posttest design with convenience scale-up sampling of 2817 preschoolers (SCALE-UP). Children receiving education and dance instruction 3 times/week for 8 weeks were assessed using the Preschool Movement Assessment to evaluate skills pre and post intervention. Using repeated measures ANOVA, McNemar and Wilcoxon signed ranks tests, preschooler's participation in the intervention resulted in greater improvement in 12 movement skills ( F = 83.451, df = 1, p < 0.001, η p 2 = 0.555), balance ( p = 0.028), hopping ( t = -3.545, df = 112, p = 0.001) and crossing the midline ( p < 0.001) than natural development (COMPARISON). In the SCALE-UP study, children significantly improved in all measures based on post-intervention scores. Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention. Therefore, implementation of interventions focused on fundamental movement skill development have the potential to remediate secular motor skill decline in young children.",2020,"Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention.","['Preschoolers Build Fundamental Motor Skills Critical to an Active Lifestyle', 'young children', '379 children (COMPARISON) and a pretest-posttest design with convenience scale-up sampling of 2817 preschoolers (SCALE-UP']",[],['12 movement skills'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]",[],"[{'cui': 'C0026649', 'cui_str': 'Movement'}]",379.0,0.0172845,"Significant differences were observed between Hispanic and non-Hispanic children for the 12-skills ( b = -0.758, se = 0.161, p < 0.001) using hierarchical linear models; boys' and girls' scores were not differentially impacted by the intervention.","[{'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Lindsay', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Starrett', 'Affiliation': 'Department of Educational Studies, College of Education, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Brian', 'Affiliation': 'Department of Physical Education, College of Education, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Byington', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Sigman-Grant', 'Affiliation': 'Extension, College of Agriculture, Biotechnology & Natural Resources (CABNR), University of Nevada, Reno, NV 89123, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17093098'] 93,32360887,Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study.,"BACKGROUND Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. METHODS We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping. RESULTS A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%). DISCUSSION This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.",2020,"BACKGROUND Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","['patients with chronic obstructive pulmonary disease', 'patients with COPD that incorporates peer and health care professional support', 'patients with COPD', 'enrolled patients receiving treatment at inpatient and outpatient settings', 'patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter', '292 patients and into this study as well as 50 family-caregivers were enrolled']","['Self-management support (SMS', 'health care professional and peer-support program']","['COPD-related and all-cause hospitalizations and ED visits', 'health-related quality of life (HRQOL', 'preparedness for caregiving, caregiver stress, and coping', 'change in HRQOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",292.0,0.0760412,"BACKGROUND Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Aboumatar', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21218, USA; Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA. Electronic address: habouma1@jhmi.edu.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naqibuddin', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neiman', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Department of Internal Medicine, Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601, USA.'}, {'ForeName': 'Jamia', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Chaudhry', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Garcia-Morales', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA; Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'McBurney', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Jager', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.'}, {'ForeName': 'Tokunbo', 'Initials': 'T', 'LastName': 'Ajayi', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bone', 'Affiliation': 'Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 601 North Caroline Street, Suite 2080, Baltimore, MD 21205, USA.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, 2024 East Monument Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Farrell', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Joo Jin', 'Affiliation': 'Department of Psychiatry, Johns Hopkins School of Medicine, 600 North Wolfe Street, Baltimore, MD 21287, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Linnell', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Pirfo', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Riley', 'Affiliation': 'BREATHE2 Study, 750 East Pratt Street, 15th floor, Baltimore, MD 21202, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salvaterra', 'Affiliation': 'Pulmonary Disease & Critical Care Medicine, Johns Hopkins Community Physicians, 11085 Little Patuxent Parkway, Columbia, MD 21044, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shea', 'Affiliation': 'Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224, USA.'}, {'ForeName': 'Jorawar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Howard County General Hospital, 5755 Cedar Lane, Columbia, MD 21044, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Pulmonary and Critical Care Medicine, The Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106023'] 94,32361032,Ethnicity moderates outcome in family focused treatment for pediatric obsessive compulsive disorder.,"OBJECTIVE This study examined predictors and moderators of treatment outcome in a randomized controlled trial (RCT) comparing two active interventions for pediatric obsessive compulsive disorder that differed with respect to the focus and format of family intervention. We had a particular interest in the role of race/ethnicity in shaping outcomes given our relatively diverse sample composition and the limited prior work in this area. METHOD A total of 62 youths (Mean age = 12.71 years; 57 % male; 34 % non-white) were assigned to either a standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET). Treatment in both arms involved 12 sessions of exposure therapy; the family interventions differed. Predictor and moderator variables were chosen based on the extant literature. RESULTS Minority status did not predict outcome, suggesting that overall, white and non-white youth had comparable treatment response. Race/ethnicity did, however, moderate response with non-white youth faring better in the ET arm of the study. In particular, minority youth in ET had, on average, post-treatment CYBOCS scores consistent with clinical remission whereas their ST counterparts were left with symptoms considered moderately severe. There were no predictors of treatment outcome. CONCLUSIONS Minority status predicts poorer response to standard CBT across disorders, suggesting the need for possible treatment adaptations. The present findings highlight one avenue for matching patients to treatments that might optimize outcomes and underscore the value of family involvement in OCD treatment.",2020,"There were no predictors of treatment outcome. ","['pediatric obsessive compulsive disorder', '62 youths (Mean age\u2009=\u200912.71 years; 57 % male; 34 % non-white']",['standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]",[],62.0,0.0176714,"There were no predictors of treatment outcome. ","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, United States.'}, {'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Pennsylvania State University, United States.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'University of Arizona, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102229'] 95,32361196,Progressive Muscle Relaxation and guided imagery as techniques to enhance the way of coping of parents of children with malignancies: Findings from a randomized controlled trial.,"PURPOSE The aim of this study was to test the effectiveness of relaxation techniques in altering the coping strategies that were employed by the parents of children with malignancy on active treatment. METHODS It was a randomized non-blinded controlled trial, including pre - and post assessments, comparing a 3-week relaxation intervention with the standard psychological care. Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece. Fifty four parents of children hospitalized with a malignancy, were randomly assigned either to the intervention group (n = 29), receiving the Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n = 25) receiving only the Standard Psychological Care by nurses and psychologists. Data were collected with the Questionnaire of 'Ways of Coping Checklist' (WofCC). RESULTS The results showed that the intervention did not have an impact on the coping strategies that parents employed as these are reflected on the WofCC' factors. The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. CONCLUSIONS The findings did not support the utilization of PMR and GI as coping strategies altering interventions in this clinical context. However, these findings should be interpreted in light of the short duration of the intervention that under these specific circumstances might have required a more lengthy approach for coping strategies to be altered. Furthermore, the stress relieving properties of these interventions could fortify (although not altering) existing coping strategies.",2020,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. ","['parents of children with malignancies', 'parents of children with malignancy on active treatment', 'Fifty four parents of children hospitalized with a malignancy', 'Participants were recruited consecutively from two Public Pediatric Oncology - Hematology Departments in Cyprus and Greece']","['Progressive Muscle Relaxation (PMR) and Guided Imagery (GI) Relaxation Techniques or to the control group (n\xa0=\xa025) receiving only the Standard Psychological Care by nurses and psychologists', 'Progressive Muscle Relaxation and guided imagery', 'relaxation intervention with the standard psychological care']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0587491', 'cui_str': 'Hematology department'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0307766,"The results showed that parents in both intervention and control group prefer using positive ways of coping in stressful situations: positive approach, positive re-evaluation and prayer/daydreaming. ","[{'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: theologia.tsitsi@cut.ac.cy.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Raftopoulos', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Mediterranean Research Centre for Public Health and Quality of Care, Limassol, Cyprus. Electronic address: vraftop1@gmail.com.'}, {'ForeName': 'Evridiki', 'Initials': 'E', 'LastName': 'Papastavrou', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Limassol, Cyprus. Electronic address: e.papastavrou@cut.ac.cy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Nursing Department, Research Centre for Oncology and Palliative Care, Limassol, Cyprus. Electronic address: andreas.charalambous@cut.ac.cy.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101718'] 96,32379201,Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials.,"This analysis includes pooled data from 2 placebo-controlled maternal influenza immunization trials, with a separate analysis on a meningococcal conjugate vaccine-controlled maternal influenza immunization trial. Maternal influenza immunization was not associated with infant or maternal all-cause mortality in placebo-controlled trials. In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine. ClinicalTrials.gov identifiers: NCT01430689, NCT01034254 and NCT02465190.",2020,"In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine.",['Women and Infants'],"['Influenza or Meningococcal Immunization', 'meningococcal conjugate vaccine']",['Maternal influenza immunization'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C3888669', 'cui_str': 'Meningococcal immunisation'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]",,0.546968,"In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine.","[{'ForeName': 'Dayna R', 'Initials': 'DR', 'LastName': 'Clark', 'Affiliation': 'From the Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale Institute for Global Health.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, Columbia.'}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002629'] 97,32380460,Pilot Randomized Trial of a Transdisciplinary Geriatric and Palliative Care Intervention for Older Adults With Cancer.,"BACKGROUND Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer. METHODS Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients' palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients' quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen's d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. RESULTS From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38). CONCLUSIONS In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients' unique care needs showed encouraging ES estimates for enhancing patients' QoL, symptom burden, and communication confidence.",2020,"Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38). ","['Older Adults With Cancer', '62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung', 'Patients aged ≥65 years with incurable gastrointestinal or lung cancer', 'eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys', 'older adults with cancer', 'From February 2017 through June 2018', 'older adults with advanced cancer']","['Transdisciplinary Geriatric and Palliative Care Intervention', 'transdisciplinary intervention', 'transdisciplinary intervention or usual care']","['QoL decrement', 'reduced number of moderate/severe symptoms', ""patients' quality of life (QoL), symptoms, and communication confidence"", 'communication confidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",62.0,0.108189,"Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38). ","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Temel', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Charn-Xin', 'Initials': 'CX', 'LastName': 'Fuh', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kay', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Landay', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lage', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Franco-Garcia', 'Affiliation': 'Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Scott', 'Affiliation': 'Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Stevens', 'Affiliation': 'Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': 'Department of Supportive Care Medicine, City of Hope National Medical Center, Duarte, California; and.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Jackson', 'Affiliation': 'Department of Medicine, Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7386'] 98,32383801,Effectiveness of a multicomponent pharmacist intervention at hospital discharge for drug-related problems: A cluster randomised cross-over trial.,"AIMS The aim of this study was to assess whether a pharmacist intervention associating medication reconciliation at discharge with a link to the community pharmacist reduces drug-related problems (DRP) in adult patients during the 7 days after hospital discharge in 22 university or general hospitals in France. METHODS We conducted a cluster randomised cross-over superiority trial with hospital units as the cluster unit. The primary outcome was a composite of any kind of DRP (prescription/dispensation, patient error or gap due to no medication available) during the 7 days after discharge, assessed by phone with the patient and community pharmacist. Among secondary outcomes, we studied self-reported unplanned hospitalisations at day 35 after discharge and severe iatrogenic problems. RESULTS A total of 1092 patients were enrolled in 48 units (538 in the experimental periods and 554 in the control periods). Three patients refused to have their data analysed and were excluded from the analyses. As compared with usual care, the pharmacist intervention led to a lower proportion of patients with at least one DRP (44.0% vs 50.6%; odds ratio [OR] 0.77, 95% confidence interval [CI] 0.61-0.98) and severe iatrogenic problems (5.2% vs 8.7%; OR 0.57, 95% CI 0.35-0.93) but no significant difference in unplanned hospitalisations at day 35 (5.8% vs 4.5%; OR 1.46, 95% CI 0.91-2.35). CONCLUSION Medication reconciliation associated with communication between the hospital and community pharmacist may decrease patient exposure to DRP and severe iatrogenic problems but not unplanned hospitalisation. However, this intervention could be recommended in health policies to improve drug management.",2020,"As compared with usual care, the pharmacist intervention led to a lower proportion of patients with at least one DRP (44.0% vs 50.6%; odds ratio [OR] 0.77, 95% confidence interval [CI] 0.61 to 0.98) and severe iatrogenic problems (5.2% vs 8.7%; OR 0.57, 95% CI 0.35 to 0.93) but no significant difference in unplanned hospitalisations at day 35 (5.8% vs 4.5%; OR 1.46, 95% CI 0.91 to 2.35). ","['1,092 patients were enrolled in 48 units (538 in the experimental periods and 554 in the control periods', 'drug-related problems', 'adult patients during the 7 days after hospital discharge in 22 university or general hospitals in France']","['pharmacist intervention', 'multicomponent pharmacist intervention']","['unplanned hospitalisations', 'severe iatrogenic problems', 'studied self-reported unplanned hospitalisations at day 35 after discharge and severe iatrogenic problems', 'composite of any kind of DRP (prescription/dispensation, patient error or gap due to no medication available']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",1092.0,0.275978,"As compared with usual care, the pharmacist intervention led to a lower proportion of patients with at least one DRP (44.0% vs 50.6%; odds ratio [OR] 0.77, 95% confidence interval [CI] 0.61 to 0.98) and severe iatrogenic problems (5.2% vs 8.7%; OR 0.57, 95% CI 0.35 to 0.93) but no significant difference in unplanned hospitalisations at day 35 (5.8% vs 4.5%; OR 1.46, 95% CI 0.91 to 2.35). ","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pourrat', 'Affiliation': 'Pharmacy Department, CHRU de Tours, Tours, France.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Leyrat', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Allenet', 'Affiliation': 'Pharmacy Department, CHU de Grenoble, Grenoble, France; ThEMAS TIMC-IMAG (UMR CNRS 5525), J Fourier University, Grenoble, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bouzige', 'Affiliation': 'Pharmacy Bouzige, 32 rue du pont, Les Salles du Gardon, 30110, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Develay', 'Affiliation': 'Pharmacy Department, CHU de Nîmes, Nîmes, France.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Fraysse', 'Affiliation': 'Pharmacy Fraysse, 52 Rue du Commandant Jean Duhail, Fontenay-sous-Bois, 94120, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Garnier', 'Affiliation': 'Pharmacie Garnier, 1 Chemin des Prés, Meynes, 30840, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Halimi', 'Affiliation': 'Nephrology Department, CHRU de Tours, Tours, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Roux-Marson', 'Affiliation': 'Pharmacy Department, CHU de Nîmes, Nîmes, France, Laboratory of Biostatistics, Epidemiology, Clinical Research and Health Economics, EA 2415, University Institute of Clinical Research, Montpellier University, Montpellier, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'INSERM CIC1415, CHRU de Tours, Tours, France; Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.'}]",British journal of clinical pharmacology,['10.1111/bcp.14349'] 99,32390559,Analysis of internal spermatic vein embolization through catheter versus laparoscopic high ligation in treatment of left varicocele.,"OBJECTIVE Varicocele is a common disease in young and middle-aged men. This study aims to compare the efficacy of internal spermatic vein embolization of left varicocele versus laparoscopic high ligation. METHODS From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option. Among these, 26 patients were treated with sclerosing agent injection, while 43 patients underwent laparoscopic surgery. They were followed up for 12 months after surgery, and the technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time with regard to these two methods were analyzed. RESULTS All patients completed the medical procedures. There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%. Furthermore, the operative time, hospitalization time, and cost of treatment were 31.1 ± 11.1 min, 1.2 ± 0.49 days, and 9613.11 ± 895.97 Yuan, respectively. In the laparoscopic group, 9 patients underwent laparoscopic bilateral high ligation, while 34 patients received treatment on the left side alone. The recurrence rate of left varicocele was 4.7% and the complication rate was 44.2%. Furthermore, the operative time, hospitalization time, and treatment cost were 50.4 ± 14.48 min, 4.0 ± 2.02 days, and 10,948.29 ± 2547.00 Yuan, respectively. Moreover, there were statistically significant differences ( P  <   0.05) in operative time, hospitalization time, and treatment cost. Patients in the sclerotherapy group had an advantage with respect to the overall complication rate when compared with patients from the laparoscopic group ( X 2  = 4.448, P  <   0.05), and there was a statistically significant difference in hydrocele ( X 2  = 4.555, P  <   0.05). However, there was no significant difference in the recurrence rate between these two groups ( X 2  = 1.245, P  >   0.05). CONCLUSION Patients who underwent sclerotherapy showed a higher technical success rate, a lower recurrence rate, fewer complications, and shorter hospitalization time compared to those treated with laparoscopic ligation. Transcatheter sclerosing agent injection may be a preferable treatment option for patients with unilateral varicocele.",2020,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","['patients with unilateral varicocele', 'young and middle-aged men', 'left varicocele', '26 patients were treated with sclerosing agent injection, while 43 patients underwent', 'From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option']","['Transcatheter sclerosing agent injection', 'laparoscopic bilateral high ligation', 'internal spermatic vein embolization through catheter versus laparoscopic high ligation', 'internal spermatic vein embolization of left varicocele versus laparoscopic high ligation', 'sclerotherapy', 'laparoscopic surgery']","['recurrence rate, fewer complications, and shorter hospitalization time', 'operative time, hospitalization time, and cost of treatment', 'recurrence rate of left varicocele', 'overall complication rate', 'technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time', 'technical success rate', 'complication rate', 'recurrence rate', 'operative time, hospitalization time, and treatment cost', 'hydrocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226718', 'cui_str': 'Structure of testicular vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1720771', 'cui_str': 'Hydrocele'}]",69.0,0.0594976,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","[{'ForeName': 'Ye-Xiang', 'Initials': 'YX', 'LastName': 'Jing', 'Affiliation': 'Department of Graduate School, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Zhao-Xuan', 'Initials': 'ZX', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Qing-Yi', 'Initials': 'QY', 'LastName': 'Meng', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}]",Vascular,['10.1177/1708538120923548'] 100,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB. OBJECTIVE To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician. METHODS AND RESULTS We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs. CONCLUSION We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001'] 101,32387209,"Invited commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"".",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0620143,,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Critical Care Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, 201700, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Wuhan Hospital of Traditional Chinese Medicine, Hubei, 430014, China. Electronic address: dhp19651226@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.073'] 102,32388622,"The effect of oxytocin, gender, and ovarian hormones on stress reactivity in individuals with cocaine use disorder.","RATIONALE Cocaine use disorder (CUD) is associated with dysregulation of the hypothalamic-pituitary-adrenal axis, which plays a critical role in the human stress response. Men and women with CUD differ in reactivity to social stressors. The hypothalamic neuropeptide oxytocin is involved in anxiolytic and natural reward processes, and has shown therapeutic potential for addictive disorders and stress reduction. OBJECTIVES To examine the impact of oxytocin (oxytocin (OXY) vs. placebo (PBO)) and gender (female (F) vs. male (M)) on response to a social stress task in individuals with CUD. To explore whether ovarian hormones moderate this stress response. METHODS One hundred twelve adults with CUD were randomized to receive 40 IU intranasal oxytocin (n = 56) or matching placebo (n = 56). Forty minutes after drug administration, participants were exposed to a social stressor. Generalized linear mixed models were used to examine neuroendocrine (cortisol) and subjective (craving, stress) response at pre-stressor, stressor + 0, + 10, + 30, + 60 min. RESULTS Gender moderated the effect of oxytocin on neuroendocrine response (p = 0.048); women receiving oxytocin (F + OXY) showed blunted cortisol response compared to the other three groups (F + PBO; M + OXY; M + PBO). There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016). Oxytocin had no significant effect on craving or stress, and gender did not moderate the effect of oxytocin on either measure. Higher endogenous progesterone was associated with lower craving response in women (p = 0.033). CONCLUSIONS Oxytocin may have differential effects in men and women with CUD. Women may be at greater risk for relapse in response to social stressors, but ovarian hormones may attenuate this effect.",2020,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"['individuals with cocaine use disorder', 'Men and women with CUD differ in reactivity to social stressors', 'One hundred twelve adults with CUD', 'individuals with CUD', 'men and women with CUD', 'gender (female (F) vs. male (M']","['oxytocin', 'oxytocin (oxytocin (OXY) vs. placebo (PBO', 'Oxytocin', '40 IU intranasal oxytocin (n\u2009=\u200956) or matching placebo']","['subjective stress response', 'blunted cortisol response', 'craving or stress', 'neuroendocrine response', 'craving response', 'neuroendocrine (cortisol) and subjective (craving, stress) response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",112.0,0.0816261,There was a main effect of gender on subjective stress response; women reported greater stress following the stressor compared to men (p = 0.016).,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Sherman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA. shermanb@musc.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nunn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC, 29425, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05516-w'] 103,32394228,"The GLP-1 receptor agonist lixisenatide reduces postprandial glucose in patients with diabetes secondary to total pancreatectomy: a randomised, placebo-controlled, double-blinded crossover trial.","AIMS/HYPOTHESIS Treatment of diabetes secondary to total pancreatectomy remains a challenge and insulin constitutes the only glucose-lowering treatment for these patients. We hypothesised that the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide would improve postprandial glucose tolerance in totally pancreatectomised patients. METHODS In a double-blinded, randomised, crossover study, 12 totally pancreatectomised individuals (age: 65.0 ± 9.5 mean±SD years; BMI: 22.9 ± 3.9 kg/m 2 ) and 12 healthy control individuals (age 66.1 ± 7.6 years; BMI: 24.0 ± 2.9 kg/m 2 ) underwent two 3 h liquid mixed-meal tests (with paracetamol for assessment of gastric emptying) after single-dose injection of 20 μg of lixisenatide or placebo. Basal insulin was given the night before each experimental day; no insulin was given during study days. RESULTS Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001). In the pancreatectomy group a mean peak glucose concentration of 23.3 ± 1.0 mmol/l was reached at time point 134 ± 11 min with placebo, compared with a mean peak glucose concentration of 18 ± 1.4 mmol/l (p = 0.008) at time point 148 ± 13 min (p = 0.375) with lixisenatide. In the control group a mean peak concentration of 8.2 ± 0.4 mmol/l was reached at time point 70 ± 13 min with placebo, compared with a mean peak concentration of 5.5 ± 0.1 mmol/l (p < 0.001) at time point 8 ± 25 min (p = 0.054) with lixisenatide. Lixisenatide also reduced gastric emptying and postprandial glucagon responses in the pancreatectomy group (66 ± 84 vs 1190 ± 311 pmol/l × min, p = 0.008) and in the control group (141 ± 100 vs 190 ± 100 pmol/l × min, p = 0.034). In the pancreatectomy group, C-peptide was undetectable in plasma. In the control group, postprandial plasma C-peptide responses were reduced with lixisenatide (18 ± 17 vs 189 ± 31 nmol/l × min, p < 0.001). CONCLUSIONS/INTERPRETATION The GLP-1 receptor agonist lixisenatide reduces postprandial plasma glucose excursions in totally pancreatectomised patients. The mode of action seems to involve deceleration of gastric emptying and reduced postprandial responses of gut-derived glucagon. TRIAL REGISTRATION ClinicalTrials.gov NCT02640118. FUNDING This study was funded by an unrestricted investigator-initiated study grant from Sanofi. Support was also received from from the Novo Nordisk Foundation Center for Basic Metabolic Research, the A.P. Møller Foundation for the Advancement of Medical Science and the Faculty of Health and Medical Sciences, University of Copenhagen.",2020,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","['patients with diabetes secondary to total pancreatectomy', 'totally pancreatectomised patients', '12 totally pancreatectomised individuals (age: 65.0\u2009±\u20099.5 mean±SD years; BMI: 22.9\u2009±\u20093.9\xa0kg/m 2 ) and 12 healthy control individuals (age 66.1\u2009±\u20097.6\xa0years; BMI: 24.0\u2009±\u20092.9\xa0kg/m 2 ) underwent']","['placebo, lixisenatide', 'glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide', 'lixisenatide or placebo', 'GLP-1 receptor agonist lixisenatide', 'two 3\xa0h liquid mixed-meal tests (with paracetamol', 'placebo']","['mean peak glucose concentration', 'postprandial plasma C-peptide responses', 'postprandial glucose tolerance', 'mean peak concentration', 'gastric emptying and postprandial glucagon responses', 'postprandial plasma glucose excursions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",12.0,0.174112,"Compared with placebo, lixisenatide reduced postprandial plasma glucose excursions in the pancreatectomy group (baseline-subtracted AUC [bsAUC] [mean±SEM]: 548 ± 125 vs 1447 ± 95 mmol/l × min, p < 0.001) and in the control group (-126 ± 12 vs 222 ± 51 mmol/l × min, p < 0.001).","[{'ForeName': 'Caroline T B', 'Initials': 'CTB', 'LastName': 'Juel', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Andersen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Carsten P', 'Initials': 'CP', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Storkholm', 'Affiliation': 'Department of Surgery and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 7, 3rd floor, DK-2900, Hellerup, Denmark. filip.krag.knop.01@regionh.dk.'}]",Diabetologia,['10.1007/s00125-020-05158-9'] 104,32396095,Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games for Children With Hemiplegia: Development and Proof-of-Concept.,"We describe the development and three case reports of a home-based intervention for children with hand hemiplegia that integrates custom video games with contralaterally controlled functional electrical stimulation (CCFES). With CCFES, stimulated opening of the more-affected hand is modulated by volitional opening of the less-affected hand. Video games that solicit goal-oriented, skill-requiring movement have shown promise for treating hemiplegia, but they have not previously been combined with electrical stimulation in children. Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia were assigned six weeks of therapy in lab and at home. The goal was to determine if children could tolerate 9 lab treatment sessions and administer up to 7.5 hrs/wk of CCFES video game therapy at home. The feasibility of this intervention for home use was assessed by device logs, end-of-treatment interviews, and motor function/impairment assessments. With caregiver help, the children were all able to attend 9 lab sessions and built up to 7.5 hrs/wk of therapy by week 3. They averaged 5-7 hrs/wk of home intervention overall. Motor outcomes improved for all three participants at treatment end, but mostly regressed at 4-weeks follow-up. Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2. We found preliminary indications that CCFES-integrated video game therapy can provide a high dose of hand motor control therapy at home and in the lab. Improvements in motor outcomes were also observed, but more development and study is needed.",2020,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","['Children with Hemiplegia', 'Three children ages 8, 9, and 11 with moderate-to-severe hand hemiplegia', 'children with hand hemiplegia that integrates']","['custom video games with contralaterally controlled functional electrical stimulation (CCFES', 'CCFES-integrated video game therapy', 'home-based intervention', 'CCFES video game therapy', 'Home-Based Functional Electrical Stimulation-Assisted Hand Therapy Video Games']",['Motor outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.063265,"Individual improvements at treatment end exceeded minimum detectable or clinically important thresholds for Assisting Hands Assessment, Fugl-Meyer Assessment, and Melbourne Motor Assessment 2.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Curby', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Suder', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Katholi', 'Affiliation': ''}, {'ForeName': 'Jayme S', 'Initials': 'JS', 'LastName': 'Knutson', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.2992036'] 105,32396972,Effect of Sodium Bicarbonate Mouth Wash on Salivary pH and Interleukin-1β Levels among Smokers.,"OBJECTIVE Smoking induces changes in salivary pH and inflammatory biomarker levels associated with oral diseases. This study examined the effect of alkaline oral rinse to modify this effect of smoking on salivary study parameters. MATERIALS AND METHODS A double-blind randomized controlled trial (RCT) on systemically healthy smokers was conducted. A total of 78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria. An alkaline mouthwash was provided to the intervention group and a placebo to control group. Salivary pH and inflammatory biomarker interleukin (IL)-1β levels were evaluated at baseline and at follow-up (14 ± 2 days). STATISTICAL ANALYSIS Chi-squared test, independaent t -test, and paired t -test were used to observe the changes in parameters among and between groups before and after intervention using SPSS v16 with a significance level of p ≤0.050. RESULTS Sixty eight salivary samples were analyzed. All study parameters of the study sample were statistically insignificant between both intervention and control groups at baseline. pH level was 6.56 ± 0.53 at baseline and 6.62 ± 0.45 at follow-up in the intervention group; respective values for control group were 6.70 ± 0.36 and 6.83 ± 0.44 and the changes were not significant ( p ≥0.071). IL-1β level was 9.39 ± 10.23 pg/µL at baseline and 5.40 ± 6.62 pg/µL at a follow-up in the intervention group and the change was significant ( p = 0.001); respective values for the control group were 10.63 ± 11.50, and 9.33 ± 11.73 and the difference was nonsignificant ( p = 0.076). CONCLUSION This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.",2020,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"['78 smokers, aged 18 to 40 years, were enrolled as per exclusion/inclusion criteria', 'systemically healthy smokers', 'Smokers']","['alkaline oral rinse', 'Sodium Bicarbonate Mouth Wash', 'sodium bicarbonate mouth rinse', 'placebo']","['IL)-1β levels', 'Salivary pH and inflammatory biomarker interleukin', 'IL-1β levels', 'IL-1β level', 'Salivary pH and Interleukin-1β Levels', 'pH level']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1304686', 'cui_str': 'pH - finding'}]",78.0,0.107795,This randomized trial indicated that sodium bicarbonate mouth rinse is effective in decreasing IL-1β levels and increasing salivary pH favorable for prevention of oral diseases.,"[{'ForeName': 'Syed Ameer', 'Initials': 'SA', 'LastName': 'Hamza', 'Affiliation': 'Department of Oral Medicine, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Arsalan', 'Initials': 'A', 'LastName': 'Wahid', 'Affiliation': 'Department of Pathology, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Afzal', 'Affiliation': 'Department of Immunology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Asif', 'Affiliation': 'Department of Periodontology, University Sains Malaysia, Kelantan, Malaysia.'}, {'ForeName': 'Mian Farrukh', 'Initials': 'MF', 'LastName': 'Imran', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, The University of Faisalabad, Faisalabad, Pakistan.'}, {'ForeName': 'Zohaib', 'Initials': 'Z', 'LastName': 'Khurshid', 'Affiliation': 'Department of Prosthodontics and Dental Implantology, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}, {'ForeName': 'Syed Akhtar Hussain', 'Initials': 'SAH', 'LastName': 'Bokhari', 'Affiliation': 'Department of Preventive Dental Sciences, College of Dentistry, King Faisal University, Al-Ahsa, Kingdom of Saudi Arabia.'}]",European journal of dentistry,['10.1055/s-0040-1709896'] 106,32334845,"Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial.","PURPOSE The purpose of this study was to compare the efficacy and safety of a proposed bevacizumab biosimilar to those of the reference product in patients with metastatic colorectal cancer (mCRC). METHODS This Phase III, multicenter, randomized, double-blind (patient- and assessor-blind), active-controlled, 2-armed, parallel-group, noninferiority trial was conducted in patients with histologically verified colorectal cancer with evidence of at least 1 metastasis. Patients with mCRC were randomized 2:1 to receive 5 mg/kg IV of either study drug plus FOLFIRI-3 (with repeated irinotecan 100 mg/m 2 60-min infusion on day 3) or the reference drug plus FOLFIRI-3 every 2 weeks for 1 year. Progression-free survival (PFS) was the primary end point, and overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity were secondary end points. The population assessable for PFS was per protocol, and the intention-to-treat population was used for sensitivity analysis. Safety was assessed based on reports of adverse events, laboratory test results, and vital sign measurements. FINDINGS A total of 126 patients were enrolled; PFS values in the biosimilar and reference arms were 232 days (7.7 months) and 210 days (7 months), respectively (P = 0.47). The hazard ratio of the biosimilar arm versus the reference arm was 0.79 in the per-protocol population (90% CI, 0.46-1.35; P = 0.47). The upper limit for the 2-sided 90% CI was lower than the margin of 1.44, indicating that the biosimilar drug was noninferior to the reference drug. The hazard ratio for overall survival in the intent-to-treat population was 0.99 (95% CI, 0.55-1.80; P = 0.99). The difference between other efficacy end points among the groups was not statistically significant. No significant difference was observed in the comparison of the two arms for safety. The antidrug antibody was positive in 1 patient in each arm. IMPLICATIONS The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs. ClinicalTrials.gov identifier: NCT03288987.",2020,"The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs.","['126 patients were enrolled', 'Patients with mCRC', 'patients with metastatic colorectal cancer', 'patients with histologically verified colorectal cancer with evidence of at least 1 metastasis', 'patients with metastatic colorectal cancer (mCRC']","['bevacizumab biosimilar BE1040V', 'bevacizumab biosimilar']","['hazard ratio\xa0for overall survival', 'Progression-free survival (PFS', 'hazard ratio', 'efficacy and safety', 'adverse events, laboratory test results, and vital sign measurements', 'overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity', 'PFS values', 'Efficacy and safety']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",126.0,0.53901,"The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammadreza', 'Initials': 'SM', 'LastName': 'Mortazavizadeh', 'Affiliation': 'Department of Internal, Faculty of Medicine, Islamic Azad University, Yazd, Iran.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Division of Hematology and Medical Oncology, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirabbas', 'Initials': 'A', 'LastName': 'Nekuee', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Safa Najjar', 'Initials': 'SN', 'LastName': 'Najafi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vahidfar', 'Affiliation': 'Yazd University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Ghadyani', 'Affiliation': 'Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siroos', 'Initials': 'S', 'LastName': 'Qarib', 'Affiliation': 'Razi Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Esfandbod', 'Affiliation': 'Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rajaeinejad', 'Affiliation': 'AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rezvani', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hajiqolami', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Payandeh', 'Affiliation': 'Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shazad', 'Affiliation': 'Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anjidani', 'Affiliation': 'Head of Medical Department, OrchidPharmed Company, Tehran, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Meskinimood', 'Affiliation': 'Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Alikhasi', 'Affiliation': 'Department of Radiology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Karbalaeian', 'Affiliation': 'Division of General Medicine of Medical School of Shaheed Sadoughi Medical School of Yazd University, Yazd, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Salari', 'Affiliation': 'Department of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: s.salari@sbmu.ac.ir.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.009'] 107,32336050,Three-Dimensional Flexible Endoscopy Can Facilitate Efficient and Reliable Endoscopic Hand Suturing: An ex-vivo Study.,"BACKGROUND/AIMS Three-dimensional (3D) flexible endoscopy, a new imaging modality that provides a stereoscopic view, can facilitate endoscopic hand suturing (EHS), a novel intraluminal suturing technique. This ex-vivo pilot study evaluated the usefulness of 3D endoscopy in EHS. METHODS Four endoscopists (two certified, two non-certified) performed EHS in six sessions on a soft resin pad. Each session involved five stitches, under alternating 3D and two-dimensional (2D) conditions. Suturing time (sec/session), changes in suturing time, and accuracy of suturing were compared between 2D and 3D conditions. RESULTS The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists. The suturing speed increased as the 3D sessions progressed. Error rates (failure to grasp the needle, failure to thread the needle, and puncture retrial) in the 3D condition were lower than those in the 2D condition, whereas there was no apparent difference in deviation distance. CONCLUSION 3D endoscopy may contribute to increasing the speed and accuracy of EHS in a short time period. Stereoscopic viewing during 3D endoscopy may help in efficient skill acquisition for EHS, particularly among novice endoscopists.",2020,"The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists.",[],"['Dimensional Flexible Endoscopy', 'Endoscopic Hand Suturing']","['speed and accuracy of EHS', 'Error rates (failure to grasp the needle, failure to thread the needle, and puncture retrial', 'deviation distance', 'Suturing time (sec/session), changes in suturing time, and accuracy of suturing', 'mean suturing time', 'suturing speed']",[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0176266,"The mean suturing time was shorter in 3D than in 2D (9.8±3.4 min/session vs. 11.2±5.1 min/session) conditions and EHS was completed faster in 3D conditions, particularly by non-certified endoscopists.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Omori', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Umeda', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Akimoto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Kirita', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Noda', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Akimoto', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Kaise', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.'}]",Clinical endoscopy,['10.5946/ce.2019.207'] 108,32272256,"No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.","The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.",2020,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","['200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration', 'patients undergoing first isolated']","['saphenous vein grafts', 'coronary computed tomography angiography', 'nonemergent coronary artery bypass grafting (CABG', 'saphenous vein grafts (SVGs) harvested with the ""no-touch"" technique', 'no-touch or conventional open skeletonized vein harvesting technique', 'coronary artery surgery (SWEDEGRAFT']","['patency of coronary artery bypass grafts', 'wound healing in the vein graft sites and the composite outcome of major adverse cardiac events', 'proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0398206', 'cui_str': 'Harvesting of vein'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]",200.0,0.0320323,"The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.","[{'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Ragnarsson', 'Affiliation': 'Skane University Hospital and Lund University, Lund, Sweden. Electronic address: sigurdur.ragnarsson@med.lu.se.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Janiec', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Dreifaldt', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ericsson', 'Affiliation': 'Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'University Hospital of Umea, Umea, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hultkvist', 'Affiliation': 'Linkoping University Hospital, Linkoping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Sartipy', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ternström', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Per Vikholm', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Domingos', 'Initials': 'D', 'LastName': 'de Souza', 'Affiliation': 'Orebro University Hospital, Orebro, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thelin', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.03.009'] 109,32272356,"Changes in alcohol use, PTSD hyperarousal symptoms, and intervention dropout following veterans' use of VetChange.","OBJECTIVE Veterans of Iraq and Afghanistan conflicts report high rates of drinking, PTSD, and low rates of treatment engagement. Web interventions may help address unmet treatment need; unfortunately, little is known regarding outcomes or adherence to these interventions. In this study, we examined VetChange treatment outcomes and downstream effects of alcohol reduction on PTSD symptoms and intervention dropout rates over six months. METHOD Participants included 222 veterans (77.5% men, 78.3% White) between 22 and 57 (mean age = 36.02, SD = 7.19). All VetChange users completed a brief alcohol assessment and received personal feedback, then received full access to intervention content including psychoeducation; motivational and cognitive-behavioral modules for relapse prevention, goal-setting, social support, stress, anger, and sleep management; and mood and drink tracking. Veterans completed self-report measures of alcohol use and PTSD symptoms at baseline, one, three, and six months. RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month. Greater alcohol reduction in the first month predicted higher subsequent PTSD hyperarousal severity. Over half (52.3%) dropped out by month one, followed by 12.2% and 37.6% by months three and six. Hyperarousal symptoms, hypervigilance specifically, but not alcohol use predicted subsequent intervention dropout. CONCLUSION These results highlight the importance of attending to the association between alcohol use and PTSD symptom change in web-based interventions for veterans. The fact that hyperarousal symptoms were associated with elevated risk for intervention dropout signifies the need for online intervention refinement aimed at tailoring content to time-varying symptom presentations.",2020,"RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month.","['Participants included 222 veterans (77.5% men, 78.3% White) between 22 and 57 (mean age\u202f=\u202f36.02, SD\u202f=\u202f7.19']","['brief alcohol assessment and received personal feedback, then received full access to intervention content including psychoeducation; motivational and cognitive-behavioral modules for relapse prevention, goal-setting, social support, stress, anger, and sleep management; and mood and drink tracking', 'alcohol reduction']","['PTSD symptoms and intervention dropout rates', 'Hyperarousal symptoms, hypervigilance', 'subsequent PTSD hyperarousal severity', 'Greater alcohol reduction']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C1273382', 'cui_str': 'Sleep management'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.00943362,"RESULTS Alcohol use dropped by 43% over six months, p < .001, with the largest decrease occurring within the first month.","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Livingston', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA. Electronic address: nicholas.livingston@va.gov.'}, {'ForeName': 'Colin T', 'Initials': 'CT', 'LastName': 'Mahoney', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ameral', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Brief', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rubin', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Enggasser', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Litwack', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmuth', 'Affiliation': 'Education Development Center, Waltham, MA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Solhan', 'Affiliation': 'Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenbloom', 'Affiliation': 'Boston University, School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Keane', 'Affiliation': 'National Center for PTSD, Behavioral Science Division, Boston, MA, USA; Department of Psychiatry, Boston University, School of Medicine, USA; U.S. Department of Veteran Affairs, VA Boston Healthcare System, Boston, MA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106401'] 110,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128'] 111,32179428,The effects of repeated transcranial direct current stimulation on sleep quality and depression symptoms in patients with major depression and insomnia.,"IMPORTANCE Although several strategies using transcranial direct current stimulation (tDCS) have been investigated to treat major depressive disorder (MDD), the efficacy of this treatment for patients with MDD who also have insomnia is unclear. OBJECTIVE To observe the effects of tDCS on sleep quality and depressive symptoms in patients with MDD who have insomnia. METHODS We conducted a randomized, double-blinded study involving adults with major depression and insomnia. We randomly assigned patients to either add tDCS or to sham tDCS to their regular treatment. After randomization, we treated a total of 90 patients at the Kangning Hospital, Ningbo, China. We allocated 47 patients to the tDCS group and 43 to the sham tDCS group. The tDCS treatment procedure included 20 sessions of 2-mA stimulation of the dorsolateral prefrontal cortex (DLPFC) for 30 min, which was followed by four weekly treatments. The anode and cathode electrodes were placed on the left and right DLPFC, respectively. We recorded the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG) at Day 1 and Day 28. RESULTS Compared with the sham tDCS group, the active tDCS group showed improved total scores of SAS and SDS. PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment. We also observed that tDCS affected sleep architecture, by increasing total sleep time and improving sleep efficiency through PSG. CONCLUSIONS Our study demonstrated the effect of tDCS on sleep quality and depressive symptoms in patients with MDD and insomnia. These results suggested that tDCS stimulation not only improved symptoms of depression and anxiety but also had a positive effect on sleep quality in patients with MDD. For patients with depression and insomnia, tDCS stimulation could be a good supplement to drugs.",2020,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","['90 patients at the Kangning Hospital, Ningbo, China', 'patients with MDD', 'patients with MDD and insomnia', 'patients with major depression and insomnia', '47 patients to the tDCS group and 43 to the sham tDCS group', 'patients with MDD who have insomnia', 'adults with major depression and insomnia']","['tDCS', 'transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'tDCS or to sham tDCS']","['total scores of SAS and SDS', 'sleep quality and depression symptoms', 'PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency', 'sleep quality', 'Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), Pittsburgh Sleep Quality Inventory (PSQI), and Polysomnography (PSG', 'symptoms of depression and anxiety', 'total sleep time', 'sleep quality and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",90.0,0.0527442,"PSQI total score and all PSQI sub-divisions, except for ""sleep duration and sleep efficiency,"" significantly improved after treatment.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Haihang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhiwang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Ningbo Kangning Hospital, Ningbo, Zhejiang, China. Electronic address: wyzhouds@sina.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.003'] 112,32220760,Performance of PI-RADS v2 assessment categories assigned prior to MR-US fusion biopsy in a new fusion biopsy program.,"OBJECTIVE To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program. MATERIAL AND METHODS Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test. RESULTS Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%. CONCLUSION PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.",2020,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","['Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified', '83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7']",['MR-US fusion biopsy'],"['csPCa rates', 'Diagnostic performance of PI-RADS', 'Rate of csPca detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]",83.0,0.0252138,"csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p < 0.0001).","[{'ForeName': 'Graham P', 'Initials': 'GP', 'LastName': 'Trent', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Graham.Trent@somalumni.umaryland.edu.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': 'University of Maryland School of Medicine, 655 W Baltimore Street, Baltimore, MD 21201, United States of America. Electronic address: Nancy.y.ye@kp.org.'}, {'ForeName': 'Jasleen', 'Initials': 'J', 'LastName': 'Chopra', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 100 North Greene Street, Suite 411, Baltimore, MD 21201, United States of America. Electronic address: rchen@umm.edu.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Wong-You-Cheong', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: jwong@umm.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naslund', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: mnaslund@som.umaryland.edu.'}, {'ForeName': 'Mohummad M', 'Initials': 'MM', 'LastName': 'Siddiqui', 'Affiliation': 'University of Maryland School of Medicine, Department of Urology, 419 W. Redwood Street, Suite 320, Baltimore, MD 21201, United States of America. Electronic address: msiddiqui@som.umaryland.edu.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Wnorowski', 'Affiliation': 'University of Maryland School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, 22 South Greene Street, Baltimore, MD 21201, United States of America. Electronic address: AmeliaWnorowski@umm.edu.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.004'] 113,32370930,Long-term changes in delay discounting following a smoking cessation treatment for patients with depression.,"BACKGROUND Delay discounting (DD) has been identified as a trans-disorder process underlying addictive behaviors, including smoking. Previous studies have evaluated how different treatments for drug dependence have affected DD, showing mixed results. Furthermore, no study has examined the effects of changes in depression on DD rates. The aim of this study was to evaluate the impact of treatment type: cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM), and changes in smoking status and depression on DD rates in long-term follow-up among a sample of treatment-seeking smokers with depression. METHODS Participants were 180 treatment-seeking smokers with depression who were randomly assigned to one of the following treatment conditions: CBT (n = 60), CBT + BA (n = 60), and CBT + BA + CM (n = 60). Depressive symptomatology and major depression diagnosis were evaluated through the BDI-II and the SCID-I of the DSM-IV-TR. DD rates were assessed using the DD task with hypothetical monetary rewards. Smoking status, DD, and depressive symptomatology were collected at baseline, at end-of-treatment and at one-, two-, three-, and six-month follow-ups. RESULTS CM for smoking cessation reduces DD rates (p = .0094). Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up. CONCLUSIONS CM interventions for smoking cessation, smoking abstinence, and the improvement of depression contribute to reductions in DD over time.",2020,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up. ","['patients with depression', 'Participants were 180 treatment-seeking smokers with depression']","['CBT', 'CBT + BA + CM', 'cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM', 'CBT + BA']","['Depressive symptomatology and major depression diagnosis', 'Smoking status, DD, and depressive symptomatology', 'Smoking abstinence', 'smoking status and depression on DD rates', 'DD rates', 'delay discounting', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",180.0,0.0288067,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up. ","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain. Electronic address: garciaperangel@uniovi.es.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Vallejo-Seco', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108007'] 114,32370931,Financial incentives promote engagement in employment services for unemployed adults in treatment for opioid use disorder.,"BACKGROUND Promoting employment among unemployed adults with substance use disorder is a difficult challenge for which existing interventions have had limited effects. This study examined whether financial incentives could increase engagement in employment services for unemployed adults in treatment for opioid use disorder. METHODS The study was conducted from 2014 to 2019 in Baltimore, MD. After a 3-month abstinence initiation and training period, participants (N = 91) were randomly assigned to a Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months. Participants assigned to the Control group (n = 47) did not receive incentives for working with the employment specialist. Participants assigned to the Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay. RESULTS Incentive participants attended the employment services and worked with the employment specialist on significantly more days than Control participants (41.8 % versus 1.1 % of days; OR = 40.42, 95 % CI = 32.46-48.38, p < .001), and for significantly more hours than Control participants (3.58 versus 1.25 h, on average; OR=2.34, 95 % CI=1.83-2.85, p < .001). Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001). CONCLUSIONS Financial incentives were effective in promoting engagement in employment services for individuals who often do not utilize employment services.",2020,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001). ","['2014 to 2019 in Baltimore, MD', 'unemployed adults with substance use disorder', 'unemployed adults', 'unemployed adults in treatment for opioid use disorder', 'individuals who often do not utilize employment services']","['Control group (n = 47) did not receive incentives for working with the employment specialist', 'Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months', 'Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay']",['employment services and worked with the employment specialist'],"[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",91.0,0.153669,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001). ","[{'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Johns Hopkins University School of Medicine, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Shrinidhi', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Arellano', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107982'] 115,32375104,Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial.,"BACKGROUND Adverse cardiac remodeling is a major risk factor for the development of post myocardial infarction (MI) heart failure (HF). This study investigates the effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute ST-segment-elevation myocardial infarction (STEMI). METHODS In this double-blind, randomized, placebo-controlled trial patients with first STEMI were eligible. To preferentially enrich patients at high risk of adverse remodeling, main inclusion criteria were a left-ventricular ejection fraction (LVEF) ≤45% and an infarct size >10% on day 5 to 9 post MI as measured by cardiac MRI. Patients were then randomized to 6 months treatment with either 25 mg fulacimstat (n = 54) or placebo (n = 53) twice daily on top of standard of care starting day 6 to 12 post MI. The changes in LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI) from baseline to 6 months were analyzed by a central blinded cardiac MRI core laboratory. RESULTS Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity. Comparable changes in LVEF (fulacimstat: 3.5% ± 5.4%, placebo: 4.0% ± 5.0%, P = .69), LVEDVI (fulacimstat: 7.3 ± 13.3 mL/m 2 , placebo: 5.1 ± 18.9 mL/m 2 , P = .54), and LVESVI (fulacimstat: 2.3 ± 11.2 mL/m 2 , placebo: 0.6 ± 14.8 mL/m 2 , P = .56) were observed in both treatment arms. CONCLUSION Fulacimstat was safe and well tolerated in patients with left-ventricular dysfunction (LVD) after first STEMI but had no effect on cardiac remodeling.",2020,"RESULTS Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.",['controlled trial patients with first STEMI were eligible'],"['chymase inhibitor fulacimstat', '25 mg fulacimstat (n\u202f=\u202f54) or placebo', 'placebo']","['safe and well tolerated and achieved mean total trough concentrations', 'safe and well tolerated', 'cardiac remodeling', 'adverse cardiac remodeling', 'LVEF, LV end-diastolic volume index (LVEDVI), and LV end-systolic volume index (LVESVI']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.55485,"RESULTS Fulacimstat was safe and well tolerated and achieved mean total trough concentrations that were approximately tenfold higher than those predicted to be required for minimal therapeutic activity.","[{'ForeName': 'Hans-Dirk', 'Initials': 'HD', 'LastName': 'Duengen', 'Affiliation': 'Department of Internal Medicine, Cardiology, Charité-Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center, Durham, United States.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Rabin Medical Center - Beilinson Campus, Cardiology Division, Petah Tikva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Admon', 'Affiliation': 'Hadassah Hebrew University Hospital Ein Kerem, Heart Institute, Jerusalem, Israel.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Kettner', 'Affiliation': 'Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Shimony', 'Affiliation': 'Department of Cardiology, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Otto', 'Affiliation': 'Experimental Medicine Cardiovascular, Bayer AG, Wuppertal, Germany. Electronic address: christiane.otto@bayer.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Becka', 'Affiliation': 'Research and Clinical Sciences Statistics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Kanefendt', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Andres Iniguez', 'Initials': 'AI', 'LastName': 'Romo', 'Affiliation': 'Hospital Alvaro Cunqueiro, Servicio de la Cardiologia, Vigo, Spain.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Hasin', 'Affiliation': 'Shaare Zedek Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Ostadal', 'Affiliation': 'Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'Gonzalo Calvo', 'Initials': 'GC', 'LastName': 'Rojas', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Division of Cardiology, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.01.012'] 116,32376313,A prospective randomized controlled trial comparing two different treatments of intrauterine adhesions.,"RESEARCH QUESTION Intrauterine adhesions (IUA) are primarily caused by trauma to the endometrium, and hysteroscopy is presently the main treatment for IUA. However, high rates of post-operative adhesion re-formation remain a problem. In this study, the combination of an intrauterine device (IUD) with a Foley catheter and the balloon uterine stent were investigated to evaluate their efficacy in preventing adhesion re-formation and the subsequent reproductive outcomes in patients with moderate to severe adhesions. DESIGN A prospective randomized controlled study was conducted in a university-affiliated hospital. A total of 171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017 and were randomized to undergo either balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter after hysteroscopic adhesiolysis. Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes were analysed. RESULTS A total of 118 participants were eligible for analysis. The American Fertility Society (AFS) scores were not significantly different between groups before hysteroscopic adhesiolysis. At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively). There were no statistically significant differences in pregnancy and live birth rates between the two groups. CONCLUSIONS The combination of an IUD and a Foley balloon catheter had better efficacy in preventing adhesion re-formation than the balloon uterine stent alone; however, it did not produce better reproductive outcomes.",2020,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[""171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017"", 'patients with moderate to severe adhesions', 'university-affiliated hospital', '118 participants were eligible for analysis']","['balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter', 'Foley balloon catheter', 'intrauterine device (IUD) with a Foley catheter and the balloon uterine stent']","['AFS scores and adhesion recurrence rates', 'American Fertility Society (AFS) scores', 'pregnancy and live birth rates', 'Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156372', 'cui_str': 'Asherman syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",171.0,0.291661,"At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively).","[{'ForeName': 'Xiao-Wan', 'Initials': 'XW', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Meng-Meng', 'Initials': 'MM', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Hong-Qin', 'Initials': 'HQ', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Nottingham University Affiliated Hospital, Nottingham Treatment Centre, Nottingham NG7 2FT, UK.'}, {'ForeName': 'Yuan-Qiu', 'Initials': 'YQ', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Ru-Ru', 'Initials': 'RR', 'LastName': 'Zheng', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China.'}, {'ForeName': 'Laura Burney', 'Initials': 'LB', 'LastName': 'Ellis', 'Affiliation': 'Lister Hospital, Stevenage, Chelsea Bridge Road, London SW1W8RH, UK.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Xia', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: 891225063@qq.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325000, PR China. Electronic address: lin801026@163.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.02.013'] 117,32376347,A pragmatic randomized trial of cardiopulmonary resuscitation training for families of cardiac patients before hospital discharge using a mobile application.,"AIM OF THE STUDY Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking. METHODS We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI. RESULTS From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was -2.3 CPM (95% CI -9.4, 4.8, p = 0.25, non-inferiority) and CC depth was -3.2 mm (95% CI -5.9, 0.1, p = 0.056). CONCLUSION In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention. CLINICAL TRIAL REGISTRATION URL: ClinicalTrials.gov, Identifier: NCT02548793.",2020,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","['1,325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white', 'family members of cardiac patients', 'family members of high-risk cardiac patients', 'families of cardiac patients before hospital discharge using a mobile application']","['CPR training', 'cardiopulmonary resuscitation (CPR) training', 'cardiopulmonary resuscitation training', 'mobile application-based (mApp) CPR training']","['CPR skills', 'CC rate', 'Mean rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1325.0,0.173811,"In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality.","[{'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Blewer', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA. Electronic address: Audrey.blewer@duke.edu.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Putt', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'McGovern', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Viera', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, USA.'}, {'ForeName': 'Raina M', 'Initials': 'RM', 'LastName': 'Merchant', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care; University of Pennsylvania, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'Department of Biostatistics, Epidemiology, & Informatics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2020.04.026'] 118,32383100,Télépied Study: A Single-Centre Trial in Diabetic Subjects Comparing Total Duration of Hospitalization Over a 1-Year Period Required for Complete Healing of a Foot Ulcer Using Telemedicine Management and a Referral Nurse Versus the Standard Care Pathway.,"PURPOSE The aim of this study is to demonstrate that the total number of days in hospital required for healing of a de novo diabetes-related foot ulcer (DFU) is lower in patients followed up using a telemedicine platform (Télépied Follow-Up group [Group 2]) than in patients followed up using standard care (Standard Follow-Up control group [Group 1]). Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week. Patients included in Group 1 are to be followed at spaced intervals during day hospital visits by the investigator assisted by a specialized referral nurse as part of the regular follow-up procedure (dressing changes + ulcer monitoring). Between visits, an independent nurse (IN) provides local care on a daily basis. Patients included in Group 2 have their DFU treated by a referral nurse trained at the diabetic foot unit of the investigating centre, and they are also followed up by an IN under the supervision of a referral nurse. In Group 2, monitoring of lesions is performed weekly by the referral nurse using photos of the DFU with planimetry taken by the IN and sent to the referral nurse via telemedicine software. The referral nurse can, in turn, provide guidance to the IN on the care to be provided and/or decide that a further hospital visit is needed. Both treatment groups are to be followed for 12 months or until complete healing of the ulcer. RESULTS Recruitment for the study began in March 2017 and ended in May 2019, with the final study visit scheduled for May 2020. CONCLUSION The aim of the Télépied study is to assess the impact of ambulatory foot ulcer management in diabetics over a 1-year period by a non-specialized IN working under the supervision of a referral nurse via telemedicine follow-up versus standard follow-up by an IN alone. The primary endpoint is the total duration of hospitalization required until full healing of the ulcer.",2020,Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week.,"['diabetics over a 1-year period by a non-specialized IN working under the supervision of a referral nurse via', 'Patients included in Group 2 have their DFU treated by a referral nurse trained at the diabetic foot unit of the investigating centre, and they are also followed up by an IN under the supervision of a referral nurse', 'Diabetic Subjects']","['telemedicine follow-up versus standard follow-up by an IN alone', 'investigator assisted by a specialized referral nurse as part of the regular follow-up procedure (dressing changes\u2009+\u2009ulcer monitoring']","['Complete Healing of a Foot Ulcer', 'total duration of hospitalization required until full healing of the ulcer']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",,0.0168346,Patients are assigned to either Group 1 or Group 2 depending on whether their first inclusion visit is during an even or odd week.,"[{'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France. dured.dardari@gmail.com.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Bobony', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Demangeon', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bouly', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Ilham', 'Initials': 'I', 'LastName': 'Xhaard', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alhajj', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Kadijatou Ly', 'Initials': 'KL', 'LastName': 'Sall', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Randazzo', 'Affiliation': 'Centre for Studies and Research for Intensification of Diabetes Therapy (CERITD), Bioparc Génopôle Evry-Corbeil, Campus 3, Bâtiment 5, 1 rue Pierre Fontaine, 91058, Evry-Cedex, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Diabetology Department, Centre Hospitalier Sud Francilien, 40 Avenue Serge Dassault, 91106, Corbeil-Essonnes, France.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00821-1'] 119,32381018,"Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).","BACKGROUND Trastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast cancer (HER2 + mBC) but has some safety issues due to taxane-induced toxicities. This has led to ongoing efforts to seek less toxic alternatives to taxanes that are equally effective when used in combination with Tmab plus Pmab. This study aims to show the non-inferiority of eribulin, a non-taxane microtubule inhibitor, against taxane, as a partner for dual HER2 blockade. METHODS/DESIGN This multicenter, randomized, open-label, parallel-group, phase III study will involve a total of 480 Japanese women with HER2 + mBC who meet the following requirements: (1) age 20-70 years; (2) no prior cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥ 6 months after prior neoadjuvant or adjuvant cytotoxic chemotherapy; (4) presence of any radiologically evaluable lesion; (5) left ventricular ejection fraction ≥ 50%; (6) Eastern Cooperative Oncology Group performance status score of 0 or 1; (7) adequate organ function; and (8) life expectancy of at least 6 months. They will be randomized 1:1 to receive eribulin (1.4 mg/m 2 on days 1 and 8) or taxane (docetaxel 75 mg/m 2 on day 1 or paclitaxel 80 mg/m 2 on days 1, 8, and 15) in combination with Tmab (8 mg/kg then 6 mg/kg) plus Pmab (840 mg then 420 mg) on day 1 of each 21-day cycle. The treatment will be continued until disease progression or unmanageable toxicity. The primary endpoint is progression-free survival as per investigator according to RECIST v1.1 criteria. Key secondary endpoints include objective response rate, overall survival, quality of life and safety. Non-inferiority will be tested with two margins of 1.33 and 1.25 in a stepwise manner. If non-inferiority is shown with a margin of 1.25, superiority will then be tested. DISCUSSION If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 + mBC in Japan. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03264547. Registered on 28 June 2017.",2020,"If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 + mBC in Japan. ","['HER2-positive, locally advanced or metastatic breast cancer', '480 Japanese women with HER2 + mBC who meet the following requirements: (1) age 20-70\u2009years; (2) no prior']","['cytotoxic chemotherapy (excluding trastuzumab-emtansine) for mBC; (3) ≥', 'taxane (docetaxel 75 mg/m 2 on day 1 or paclitaxel 80 mg', 'Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane', 'Trastuzumab (Tmab), pertuzumab (Pmab), and taxane', 'plus Pmab', 'taxane microtubule inhibitor, against taxane', 'adjuvant cytotoxic chemotherapy']","['progression-free survival', 'objective response rate, overall survival, quality of life and safety']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1563757', 'cui_str': 'Microtubule inhibitor-containing product'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",480.0,0.102615,"If this study shows the non-inferiority, or even superiority, of Tmab, Pmab, and eribulin against the existing taxane-containing regimen, this new regimen may become a standard first- or second-line treatment option for HER2 + mBC in Japan. ","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. tyamashita@kcch.jp.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Department of Medical Oncology, Fukushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma, 373-8550, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon Minato-ku, Tokyo, 105-8470, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Breast Surgery, NHO Hokkaido Cancer Center, 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Department of Medical Oncology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Breast Surgery, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Breast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Breast and Endocrine Surgical Oncology, Tohoku University Hospital, 1-1 Seiryocho Aoba-ku Sendai-shi, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Iwasa', 'Affiliation': 'Oncology Internal Medicine, Kindai University Hospital, 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kadoya', 'Affiliation': 'Breast Surgery, Hiroshima University Hospital, 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Tsuguo', 'Initials': 'T', 'LastName': 'Iwatani', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Eisai Co., Ltd., 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}]",Trials,['10.1186/s13063-020-04341-y'] 120,32383985,"Correction: A comparative, single-blind, randomized study on quetiapine and aripiperazole augmentation in treatment of selective serotonin reuptake inhibitor refractory obsessive-compulsive disorder.",,2020,,[],['quetiapine and aripiperazole augmentation'],[],[],"[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.0158538,,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farhad Farid', 'Initials': 'FF', 'LastName': 'Hosseini', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghili', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Asadpour', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neema John', 'Initials': 'NJ', 'LastName': 'Mehramiz', 'Affiliation': 'The University of Arizona, College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Forouzanfar', 'Affiliation': 'Neuroscience Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Canadian journal of physiology and pharmacology,['10.1139/cjpp-2020-0207'] 121,32384205,The efficacy and safety of a 577-nm high-power optically pumped semiconductor laser in the treatment of postacne erythema.,"BACKGROUND Postacne erythema (PAE) is a common sequela of inflammatory acne vulgaris, treatment of which has been challenging due to limited options available and the variability of results for each modality. Recently, a 577-nm high-power optically pumped semiconductor laser (HOPSL) initially developed for vascular lesions has shown promising results for the treatment of PAE. AIMS To evaluate the efficacy and safety of 577-nm HOPSL in the treatment of postacne erythema. METHODS This was a split-face, randomized controlled trial pilot study. Twenty-one patients with PAE on both sides of their face were enrolled. Each subject's face sides were randomly assigned to either receive 577-nm HOPSL treatment (QuadroStar PRO™, Asclepion Laser Technologies) using the scanner handpiece, 1mm spot size, 80% coverage, 12-15 J/cm 2 , 30 ms, 2 passes for 3 sessions at 1-month intervals, or no treatment at all. Outcome measures such as overall improvement, the Erythema Index (EI), and Melanin Index (MI) from 3 different areas on both treatment and control sides were assessed at baseline, and 1-month follow-up after each treatment session. Side effects including pain, erythema, swelling, and crusting were also recorded. RESULTS Upon completion of the treatment period, the mean EI was significantly decreased in both treated and nontreated sides of the face (P < .001 and P = .001, respectively). The laser-treated sides already demonstrated significant reduction in the mean EI compared with nontreated sides at 1 month after the 2nd treatment (P = .007). The mean MI of both sides, however, did not show any statistically significant differences from baseline, and likewise when comparing between sides. Patients reported more improvement on laser-treated sides compared with nontreated sides. Reported side effects were limited to mild discomfort during treatment and transient facial erythema lasting approximately 30 minutes. CONCLUSION Patients who received treatment with the 577-nm HOPSL had better outcomes with minimal side effects at 1 month after 2 treatments as compared to those who did not receive any treatment. Therefore, the 577-nm HOPSL may be considered as an effective adjuvant treatment for PAE and early erythematous atrophic scars.",2020,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"['Twenty-one patients with PAE on both sides of their face were enrolled', 'postacne erythema']","['577-nm high-power optically pumped semiconductor laser (HOPSL', '577-nm HOPSL', '577-nm HOPSL treatment (QuadroStar PRO TM , Asclepion Laser Technologies, Jena, Germany) using the scanner handpiece', '577-nm high-power optically pumped semiconductor laser']","['minimal side effects', 'overall improvement, the Erythema Index (EI) and Melanin Index (MI', 'mean MI of both sides', 'efficacy and safety', 'pain, erythema, swelling, and crusting', 'mean EI']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0181115', 'cui_str': 'Handpiece'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205204', 'cui_str': 'Crust'}]",21.0,0.0328977,The laser-treated sides already demonstrated significant reduction in the mean EI compared to non-treated sides at 1 month after the 2nd treatment (p=0.007).,"[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kathryn Anne G', 'Initials': 'KAG', 'LastName': 'Cembrano', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Waritch', 'Initials': 'W', 'LastName': 'Kobwanthanakun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Weeranut', 'Initials': 'W', 'LastName': 'Phothong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fritz', 'Affiliation': 'Dermatology and Laser Center, Landau, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Salavastru', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13474'] 122,32386720,"Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.","BACKGROUND Although antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy. METHODS An open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV were assigned to antiretroviral regimens containing either raltegravir (400 mg twice daily) or efavirenz (600 mg each night) plus lamivudine 150 mg and zidovudine 300 mg twice daily (or approved alternative backbone regimen), using a web-based, permuted-block randomisation stratified by gestational age and backbone regimen. The primary efficacy outcome was plasma HIV viral load below 200 copies per mL at (or near) delivery. The primary efficacy analysis included all women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria. The primary safety analyses included all women who received study drug, and their infants. This trial is registered with Clinicaltrials.gov, number NCT01618305. FINDINGS From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome (absolute difference 10%, 95% CI 3-18; p=0·0015); the difference primarily occurred among women enrolling later in pregnancy (interaction p=0·040). Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. INTERPRETATION Our findings support major guidelines. The integrase inhibitor dolutegravir is currently a preferred regimen for the prevention of perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.",2020,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. ","['non-pregnant adults', 'women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria', '19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA', 'Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV', 'antiretroviral-naive pregnant women living with HIV (NICHD P1081', 'From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz', 'pregnant women living with HIV', '144']","['lamivudine 150 mg and zidovudine', 'raltegravir', 'raltegravir or efavirenz', 'efavirenz', 'Raltegravir versus efavirenz']","['Frequencies of severe or life-threatening adverse events', 'safety and efficacy', 'plasma HIV viral load below 200 copies per mL at (or near) delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0987069', 'cui_str': 'Lamivudine 150 MG'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",408.0,0.357245,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. ","[{'ForeName': 'Esaú C', 'Initials': 'EC', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Electronic address: esaujoao@gmail.com.'}, {'ForeName': 'R Leavitt', 'Initials': 'RL', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Maria Isabel S', 'Initials': 'MIS', 'LastName': 'Gouvèa', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Lourdes B Teixeira', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Trevon L', 'Initials': 'TL', 'LastName': 'Fuller', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Boniface N', 'Initials': 'BN', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mathiba', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Zaakirah', 'Initials': 'Z', 'LastName': 'Essack', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Jose Henrique S', 'Initials': 'JHS', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Moreira', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rolon', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University and Chiangrai Prachanukroh Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Peerawong', 'Initials': 'P', 'LastName': 'Werarak', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Laimon', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Hennessy', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""University of Washington and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Anthony', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'US Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30038-2'] 123,32393099,Budesonide vs Saline Nasal Irrigation in Allergic Rhinitis: A Randomized Placebo-Controlled Trial.,"OBJECTIVES Budesonide nasal irrigation is currently widely used in the treatment of chronic sinusitis typically following endoscopic sinus surgery to improve inflammatory control. Its application in treatment of allergic rhinitis has not been previously studied. This study assesses the subjective and clinical response to budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation in patients with allergic rhinitis. STUDY DESIGN This is a prospective, single-center, double-blind, randomized placebo-controlled trial. SETTING Tertiary care hospital. SUBJECTS AND METHODS Fifty-two patients diagnosed with allergic rhinitis were randomized into 2 groups to receive either buffered hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule. Patients were assessed at baseline and 4 weeks subjectively using the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS). Clinical assessment was done using the modified Lund-Kennedy score. RESULTS The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001). The budesonide irrigation group was found to have significantly better improvement than the saline nasal irrigation group with the SNOT-22 scores ( P = .012) and VAS scores ( P = .007). However, the difference in the clinical response between the 2 groups was not significant ( P = .268). CONCLUSION This study adds evidence to the use of saline nasal irrigation in allergic rhinitis but also demonstrates efficacy of the addition of budesonide to irrigations. Budesonide nasal irrigation thus appears to be a viable treatment option for allergic rhinitis.",2020,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001).","['Allergic Rhinitis', 'Fifty-two patients diagnosed with allergic rhinitis', 'Tertiary care hospital', 'patients with allergic rhinitis']","['Placebo', 'budesonide irrigation', 'budesonide buffered hypertonic saline nasal irrigation and hypertonic saline nasal irrigation', 'hypertonic saline nasal irrigation with a placebo respule or buffered hypertonic saline nasal irrigation with a budesonide respule', 'Budesonide', 'Saline Nasal Irrigation', 'saline nasal irrigation', 'Budesonide nasal irrigation', 'placebo']","['Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire and visual analog scale (VAS', 'clinical response', 'average SNOT-22, VAS, and modified Lund-Kennedy scores', 'SNOT-22 scores', 'VAS scores']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",52.0,0.0682754,"The average SNOT-22, VAS, and modified Lund-Kennedy scores improved in both groups ( P < .001).","[{'ForeName': 'Nikitha', 'Initials': 'N', 'LastName': 'Periasamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Kailesh', 'Initials': 'K', 'LastName': 'Pujary', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ajay M', 'Initials': 'AM', 'LastName': 'Bhandarkar', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Naveen D', 'Initials': 'ND', 'LastName': 'Bhandarkar', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, University of California, Irvine, California, USA.'}, {'ForeName': 'Balakrishnan', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Otorhinolaryngology-Head and Neck Surgery, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820919363'] 124,30858609,Relationship between vitamin D status and the vaginal microbiome during pregnancy.,"OBJECTIVE Evidence supports an inverse association between vitamin D and bacterial vaginosis (BV) during pregnancy. Furthermore, both the vaginal microbiome and vitamin D status correlate with pregnancy outcome. Women of African ancestry are more likely to experience BV, to be vitamin D deficient, and to have certain pregnancy complications. We investigated the association between vitamin D status and the vaginal microbiome. STUDY DESIGN Subjects were assigned to a treatment (4400 IU) or a control group (400 IU vitamin D daily), sampled three times during pregnancy, and vaginal 16S rRNA gene taxonomic profiles and plasma 25-hydroxyvitamin D [25(OH)D] concentrations were examined. RESULT Gestational age and ethnicity were significantly associated with the microbiome. Megasphaera correlated negatively (p = 0.0187) with 25(OH)D among women of African ancestry. Among controls, women of European ancestry exhibited a positive correlation between plasma 25(OH)D and L. crispatus abundance. CONCLUSION Certain vaginal bacteria are associated with plasma 25(OH)D concentration.",2019,Megasphaera correlated negatively (p = 0.0187) with 25(OH)D among women of African ancestry.,['Subjects'],[],"['plasma 25-hydroxyvitamin D [25(OH)D] concentrations', 'Megasphaera', 'Gestational age and ethnicity', 'plasma 25(OH)D and L. crispatus abundance']",[],[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0317723', 'cui_str': 'Megasphaera'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]",,0.0727955,Megasphaera correlated negatively (p = 0.0187) with 25(OH)D among women of African ancestry.,"[{'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Jefferson', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Hardik I', 'Initials': 'HI', 'LastName': 'Parikh', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Garcia', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Center for the Study of Biological Complexity, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Myrna G', 'Initials': 'MG', 'LastName': 'Serrano', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hewison', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina Children's Hospital, Charleston, SC, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Powell', 'Affiliation': 'Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina Children's Hospital, Charleston, SC, USA.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Fettweis', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Jerome F', 'Initials': 'JF', 'LastName': 'Strauss Iii', 'Affiliation': 'Center for the Study of Biological Complexity, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Buck', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA. gregory.buck@vcuhealth.org.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': ""Division of Neonatology, Shawn Jenkins Children's Hospital, Medical University of South Carolina Children's Hospital, Charleston, SC, USA. wagnercl@musc.edu.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0343-8'] 125,32392560,"The Results Given in the Paper by Bruyère et al. ""Multicenter, Randomized, Placebo-Controlled Study [of] the Efficacy of a Combination of Propolis and Cranberry… (DUAB®) in Preventing Low Urinary Tract Infection Recurrence in Women… [with] Recurrent Cystitis"" Should Be Used with Great Caution.",,2020,,['Women'],"['Placebo', 'Combination of Propolis and Cranberry… (DUAB®']",['… [with] Recurrent Cystitis'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}]","[{'cui': 'C0581366', 'cui_str': 'Recurrent cystitis'}]",,0.0523368,,"[{'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Botto', 'Affiliation': 'Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Dreyfus', 'Affiliation': 'DReyfusConsultancyInternational, Methodology & Statistics, Bouère, France, jf@jfdreyfus.org.'}]",Urologia internationalis,['10.1159/000506020'] 126,32334332,The effects of consecutive sessions of anodal transcranial direct current stimulation over the primary motor cortex on hand function in healthy older adults.,"BACKGROUND With advancing age, changes in the central nervous system may lead to motor functional deficits. Non-invasive brain stimulation techniques are suggested to help modifying brain function. OBJECTIVES The aim of the current study was to investigate the effect of using multi session anodal transcranial Direct Current Stimulation (a-tDCS) over the primary motor cortex (M1) on the hand function in healthy older adults. METHOD In this randomized, double-blinded, sham-controlled study 32 participants received active or sham a-tDCS (1 mA, 20 min, for five consecutive days) and performed the Purdue Pegboard Test (PPT) on the first day before tDCS application, immediately (T1), 30 min (T2), and one week after the last session (5th day) (T3) of the stimulation. RESULTS There was a significant improvement for PPT (p < 0.05) in a-tDCS group at all post-test values except for PPT for left hand (PPTL) at T1. Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group. CONCLUSION The current findings suggest a-tDCS can be considered as a promising stand-alone technique in the intervention of the age-related decline of manual dexterity for improving hand function.",2020,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group. ","['32 participants received', 'healthy older adults']","['multi session anodal transcranial Direct Current Stimulation (a-tDCS', 'active or sham a-tDCS', 'anodal transcranial direct current stimulation']","['PPT', 'PPT subtests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}]",32.0,0.0611213,"Compared to the sham group, the results indicated significant improvement in all PPT subtests (P < 0.05), except for PPTL at T1, PPT for both hands at T2 and PPT assembly at T3 in a-tDCS group. ","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Speech Therapy Department, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center on Aging, Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104063'] 127,32370906,"Editorial Commentary: Spinning ""Spin"" in Randomized Trials in Orthopaedic Surgery.","Reporting the results of a randomized trial can be complex. In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful. ""Spinning"" the results of a study to show them to be more favorable than they are in reality is a form of reporting bias. The best way around potential reporting bias is for readers to read the methods section first to evaluate exactly what was done, followed by the results section to interpret the outcomes and analysis. Then, and only then, can readers decide whether the findings are relevant to them and their patients.",2020,"In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful.",[],[],[],[],[],[],,0.0566112,"In some cases, the primary outcome may not achieve statistical significance (usually defined as P ≤ .05) but the information may be clinically meaningful.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Marx', 'Affiliation': 'New York, New York.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.041'] 128,31813273,Primary Care Practitioner Training in Child and Adolescent Psychiatry (PTCAP): A Cluster-Randomized Trial.,"OBJECTIVES Rural primary care practitioners (PCPs) have a pivotal role to play in frontline pediatric mental health care, given limited options for referral and consultation. Yet they report a lack of adequate training and confidence to provide this care. The aim of this study was to test the effectiveness of the Practitioner Training in Child and Adolescent Psychiatry (PTCAP) program, which was designed to enhance PCPs' pediatric mental health care confidence. The program includes brief therapeutic skills and practice guidelines PCPs can use to address both subthreshold concerns and diagnosable conditions, themselves. METHODS The study design was a pilot, cluster-randomized, multicenter trial. Practices were randomly assigned to intervention ( n practices = 7; n PCPs = 42) or to wait-list control ( n practices = 6; n PCPs = 34). The intervention involved 8 hr of training in practice guidelines and brief therapeutic skills for depression, anxiety, attention deficit hyperactivity disorder, and behavioral disorders with case discussion and video examples, while the control practiced as usual. A linear random-effects model controlling for clustering and baseline was carried out on the individual-level data to examine between-group differences in the primary (i.e., confidence) and secondary (i.e., attitude and knowledge) outcomes at 1-week follow-up. RESULTS Findings were a statistically significant difference in the primary outcomes. Compared to the control group, the intervention group indicated significantly greater confidence in managing diagnosable conditions ( d = 1.81) and general concerns ( d = 1.73), as well as in making necessary referrals ( d = 1.27) and obtaining consults ( d = 0.74). While the intervention did not significantly impact secondary outcomes (attitudes and knowledge), regression analysis indicated that the intervention may have increased confidence, in part, by ameliorating the adverse impact of negative mental health care attitudes. CONCLUSION PTCAP enhances PCPs' child/youth mental health care confidence in managing both general and diagnosable concerns. However, an 8-hr session focused on applying brief therapeutic skills was insufficient to significantly change attitudes and knowledge. Formal testing of PTCAP may be warranted, perhaps using more intensive training and including outcome assessments capable of determining whether increased PCP confidence translates to more effective management and better patient outcomes.",2020,"Compared to the control group, the intervention group indicated significantly greater confidence in managing diagnosable conditions ( d = 1.81) and general concerns ( d = 1.73), as well as in making necessary referrals ( d = 1.27) and obtaining consults ( d = 0.74).","['in Child and Adolescent Psychiatry (PTCAP', 'Rural primary care practitioners (PCPs', 'Child and Adolescent Psychiatry (PTCAP) program']","['Practitioner Training', 'intervention ( n practices = 7; n PCPs = 42) or to wait-list control', 'PTCAP', 'Primary Care Practitioner Training']","['adverse impact of negative mental health care attitudes', 'greater confidence in managing diagnosable conditions']","[{'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274032', 'cui_str': 'Child and adolescent psychiatry'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0709654,"Compared to the control group, the intervention group indicated significantly greater confidence in managing diagnosable conditions ( d = 1.81) and general concerns ( d = 1.73), as well as in making necessary referrals ( d = 1.27) and obtaining consults ( d = 0.74).","[{'ForeName': 'Stacey D', 'Initials': 'SD', 'LastName': 'Espinet', 'Affiliation': 'Department of Psychiatry, Schulich School of Medicine & Dentistry, Centre for Education Research and Innovation, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gotovac', 'Affiliation': 'Division of Child and Adolescent Psychiatry, London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Sommer', 'Initials': 'S', 'LastName': 'Knight', 'Affiliation': 'Department of Psychiatry, Schulich School of Medicine & Dentistry, Centre for Education Research and Innovation, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Wissow', 'Affiliation': 'School of Medicine, University of Washington, DC, USA.'}, {'ForeName': 'Merrick', 'Initials': 'M', 'LastName': 'Zwarenstein', 'Affiliation': 'Department of Family Medicine, Centre for Studies in Family Medicine, The University of Western Ontario, Ontario, Canada.'}, {'ForeName': 'Lorelei', 'Initials': 'L', 'LastName': 'Lingard', 'Affiliation': 'Centre for Education Research and Innovation, Health Sciences Addition, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': ""Discipline of Psychiatry, Faculty of Medicine, Memorial University of Newfoundland, Saint John's, Newfoundland, Canada.""}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719890161'] 129,32320845,Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment.,"The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. The methodology also allows us to explore the implementation and sustainability of a technology-enhanced intervention in more than two dozen community practice settings. This paper includes a description and justification for sample selection and recruitment procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context. Challenges related to the implementation of a technology-enhanced intervention in existing mental health clinics are discussed, as well as implications for future research and practice.",2020,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,['child mental health treatment'],['tablet-based application'],"['provider fidelity and child engagement', 'quality of care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",,0.040181,Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context.,"[{'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Anton', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America. Electronic address: antonm@musc.edu.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Ridings', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Hanson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Davidson', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'Department of Psychological Science, University of Vermont, John Dewey Hall, Rm 248, 2 Colchester Ave., Burlington, VM 05405, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Kmett Danielson', 'Affiliation': 'National Crime Victims Center, Department of Psychiatric and Behavioral Services, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chu', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers University, 152 Frelinghuysen Rd., Piscataway, NJ 08854, United States of America.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke', 'Affiliation': 'Health Economics Resource Center (HERC), VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA 94025, United States of America.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, School of Medicine, Indiana University, 410 West 10th Street, Indianapolis, IN 46202, United States of America.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ruggiero', 'Affiliation': 'Technology Applications Center for Healthful Lifestyles, College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St., MSC 160, Charleston, SC 29425, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106010'] 130,32389808,Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.,"INTRODUCTION Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice. MATERIAL AND METHODS Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet. PRIMARY OUTCOMES Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism. SECONDARY OUTCOMES Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation. DISCUSSION This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy. CLINICAL TRIAL REGISTRATION NCT03146156.",2020,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy. ","['pregnancy (LIPP', 'Overweight/class 1 obese women after a previous pregnancy, ~12', 'women planning for pregnancy']","['LIPP', 'lifestyle intervention']","['umbilical cord blood insulin resistance, lipid profile and inflammation', 'maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life', 'utero metabolic milieu', 'neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",1.0,0.119724,"Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy. ","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gordesky', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': 'Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Tierney-Ginn"", 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Catalano', 'Affiliation': 'Department of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106024'] 131,32392833,"Effects of Augmented-Reality-Based Exercise on Muscle Parameters, Physical Performance, and Exercise Self-Efficacy for Older Adults.","This study was intended to determine the applicability of an augmented-reality-based muscle reduction prevention exercise program for elderly Korean women by observing changes in exercise self-efficacy and verifying the effectiveness of the program in the elderly after the application of the program. A total of 27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study. They were divided into an experimental group (13 people) and a control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program was applied. This was a 30-min program, which included regular, aerobic, and flexibility exercises, and it was applied 5 times a week for 12 weeks. As a result of observing changes, it was found that the appendicular skeletal muscle mass (ASM) (F = 11.222, p < 0.002) and the skeletal muscle index (SMI) (kg/m 2 ) (F = 10.874, p < 0.003) muscle parameters increased more in the experimental group compared to the control group, and there was a significant increase in gait speed (m/s) (F = 7.221, p < 0.005). For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110, p < 0.033), 2-min step test (2MST) (F = 6.621, p < 0.020), and the timed up-and-go test (TUG) (F = 5.110, p < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464, p < 0.001). Finally, the augmented-reality-based exercise program in this study was found to be effective in inducing physical activity in the elderly. Therefore, the augmented-reality-based muscle reduction prevention exercise program is considered to be effective in increasing the sustainability of exercise, thus preventing muscle reduction in the elderly.",2020,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110, p < 0.033), 2-min step test (2MST) (F = 6.621, p < 0.020), and the timed up-and-go test (TUG) (F = 5.110, p < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464, p < 0.001).","['elderly Korean women', '27 participants, who were elderly women aged 65+ and had not participated in any exercise programs until this study, were recruited for this study', 'Older Adults']","['Augmented-Reality-Based Exercise', 'augmented-reality-based muscle reduction prevention exercise program', 'control group (14 people), and then the augmented-reality-based muscle reduction prevention exercise program']","['exercise self-efficacy', 'appendicular skeletal muscle mass (ASM', 'physical activity', 'gait speed (m/s', 'skeletal muscle index (SMI', 'Muscle Parameters, Physical Performance, and Exercise Self-Efficacy', 'chair stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",27.0,0.0120384,"For physical performance, as a result of conducting the Senior Fitness Test (SFT), a significant change was observed in the chair stand test (F = 5.110, p < 0.033), 2-min step test (2MST) (F = 6.621, p < 0.020), and the timed up-and-go test (TUG) (F = 5.110, p < 0.032) and a significant increase was also observed for exercise self-efficacy (F = 20.464, p < 0.001).","[{'ForeName': 'Sangwan', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Exercise Rehabilitation Convergence Institute, Gachon University191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'Jiyoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation & Welfare, Gachon University 191 Hombakmoero, Yeonsu-gu, Incheon 406799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17093260'] 132,32394350,Carboplatin plus taxanes are non-inferior to epirubicin plus cyclophosphamide followed by taxanes as adjuvant chemotherapy for early triple-negative breast cancer.,"PURPOSE Platinum plays an important role in the treatment of triple-negative breast cancer (TNBC) in neoadjuvant and metastatic settings. However, its role in an adjuvant setting remains unclear. METHODS In this non-inferior randomized phase 2 trial, we randomly assigned 308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery to receive either six cycles of TP (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m 2 ; cyclophosphamide: 600 mg/m 2 , day 1) followed by four cycles of T (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 , day 1). The primary end point was the disease-free survival (DFS) rate at 5 years. Both regimens were repeated every 3 weeks. The prognostic and predictive value of germline breast cancer gene mutations and programmed death ligand-1 (PD-L1) expression was evaluated. RESULTS At a median follow-up of 66.9 months, the 5-year DFS rate was 85.8% in the EC-T arm, and 84.4% in the TP arm (p non-inferiority = 0.034, p log-rank = 0.712). The 5-year overall survival (OS) rate was 94.4% in the EC-T arm and 93.5% in the TP arm (p = 0.770). Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm. Patients with PD-L1 expressing tumors showed significantly improved DFS and OS. CONCLUSIONS This study indicates that carboplatin plus taxanes could be a feasible adjuvant chemotherapy for patients with early TNBC who are cannot tolerate intensive chemotherapy with anthracycline.",2020,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","['patients with early TNBC who are cannot tolerate intensive chemotherapy with', 'early triple-negative breast cancer', '308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery']","['carboplatin plus taxanes', 'cyclophosphamide', 'TP (docetaxel: 75\xa0mg/m 2 or paclitaxel 175\xa0mg/m 2 d1; carboplatin AUC', 'T (docetaxel: 75\xa0mg/m 2 or paclitaxel', 'epirubicin plus cyclophosphamide', 'Carboplatin plus taxanes', 'EC (epirubicin', 'anthracycline']","['5-year DFS rate', '5-year overall survival (OS) rate', 'frequencies of G3/4 neutrocytopenia and G3/4 alopecia', 'rates of G1-4 thrombocytopenia', 'DFS and OS', 'disease-free survival (DFS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",308.0,0.0638024,"Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1-4 thrombocytopenia than those in the EC-T arm.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wenmiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shandong Cancer Hospital/Institute, Jinan, 250117, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Zhu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Todorovic', 'Affiliation': 'Clinical Centre of MontenegroClinic for Oncology and Radiotherapy, Podgorica, Montenegro.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yuanpeng01@hotmail.com.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xubingheBM@163.com.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05648-9'] 133,32397597,"A 4 Year Human, Randomized, Radiographic Study of Scalloped versus Non-Scalloped Cemented Implants.","Marginal bone loss (MBL) is a key factor in long-term implant success rate. Among the different factors that influence MBL, it is the different implant shoulder designs, such as scalloped or non-scalloped, which have been widely studied on screw retained but not on cemented retained implants. Thus, the aim of the present study was to evaluate the MBL around scalloped and non-scalloped cemented retained dental implants after 4 years of loading, in humans. A total of 15 patients were enrolled in the present study. A radiographic and clinical examination was performed after implant placement (T0) and after 4 years from it (T1). The results demonstrated a differential MBL (T1-T0) of 2.436 ± 1.103 mm and 1.923 ± 1.021 mm, respectively for test (scalloped) and control (non-scalloped) groups with a statistically significant difference between them. On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups. In conclusion, the use of a scalloped platform did not provide better results on the maintenance of MBL after 4 years follow-up. In this study, this probably was determined by multiple factors, among which was the subcrestal insertion of scalloped implants.",2020,"On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups.","['after 4 years of loading, in humans', 'A total of 15 patients were enrolled in the present study']","['MBL around scalloped and non-scalloped cemented retained dental implants', 'Scalloped versus Non-Scalloped Cemented Implants']","['Marginal bone loss (MBL', 'prosthetic complication and abutment decementation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0324026', 'cui_str': 'Scallop'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",15.0,0.0479813,"On the other hand, no statistically significant differences were found between the groups in terms of prosthetic complication and abutment decementation, whilst ceramic crowns chipping was shown in both groups.","[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sinjari', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': ""D'Addazio"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Manlio', 'Initials': 'M', 'LastName': 'Santilli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': ""D'Avanzo"", 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Imena', 'Initials': 'I', 'LastName': 'Rexhepi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Scarano', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Tonino', 'Initials': 'T', 'LastName': 'Traini', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Piattelli', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Caputi', 'Affiliation': 'Department of Medical, Oral and Biotechnological Sciences, University ""G. d\'Annunzio"" of Chieti-Pescara, 66100 Chieti, Italy.'}]","Materials (Basel, Switzerland)",['10.3390/ma13092190'] 134,32334033,Acute Toxicity and Quality of Life of Hypofractionated Radiation Therapy for Breast Cancer.,"PURPOSE To assess the acute toxicity and quality of life (QOL) of hypofractionation compared with conventional fractionation for whole breast irradiation (WBI) after breast-conserving surgery. METHODS AND MATERIALS Women with node-negative breast cancer who had undergone breast-conserving surgery with clear margins were randomly assigned to conventional WBI of 5000 cGy in 25 fractions over 35 days or hypofractionated WBI of 4256 cGy in 16 fractions over 22 days. Acute skin toxicity and QOL were assessed at baseline and 2, 4, 6, and 8 weeks from the start of treatment for a subgroup of patients. QOL was assessed at baseline and 4 weeks posttreatment for all patients. In the acute toxicity substudy, repeated measures modeling was used to investigate treatment by time interactions over the 8-week period for acute toxicity and QOL mean change score. QOL mean change score from baseline to 4 weeks posttreatment was compared for all patients. RESULTS In the acute toxicity substudy, 161 patients participated. In the main trial, 1152 patients participated. Acute skin toxicity was initially similar between groups but was less with hypofractionation compared with conventional fractionation toward the end of the 8-week period (P < .001). QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness, and convenience domains (all P < .05). In the main trial, hypofractionation resulted in improved overall QOL and QOL attributed to skin side effects, breast side effects, and attractiveness (all P < .01). CONCLUSIONS Hypofractionated WBI compared with conventional WBI resulted in less acute toxicity and improved QOL. This further supports the benefits of hypofractionation.",2020,"QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness and convenience domains (all p < 0.05).","['1152 patients participated', 'Breast Cancer', 'Women with node negative breast cancer who had undergone BCS with clear margins']","['Hypofractionated Radiotherapy', 'conventional WBI', 'conventional fractionation for whole breast irradiation (WBI) following breast conserving surgery (BCS', 'conventional WBI of 5000 cGy in 25 fractions over 35 days or hypofractionated WBI']","['skin side effects, breast side effects, fatigue, attractiveness and convenience domains', 'acute toxicity and improved QOL', 'acute toxicity and QOL mean change score', 'QOL mean change score', 'Acute skin toxicity', 'QOL attributed to skin side effects, breast side effects, and attractiveness', 'QOL', 'Acute Toxicity and Quality of Life', 'Acute skin toxicity and QOL', 'overall QOL', 'acute toxicity and quality of life (QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C1709157', 'cui_str': 'Tumor-Free Margins'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1152.0,0.104901,"QOL at 6 weeks from the start of treatment was improved with hypofractionation for the skin side effects, breast side effects, fatigue, attractiveness and convenience domains (all p < 0.05).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Arsenault', 'Affiliation': 'Department of Radiation Oncology, Dr. Léon Richard Oncology Centre, Moncton, New Brunswick, Canada.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Parpia', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Goldberg', 'Affiliation': 'Division of Radiation Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Rakovitch', 'Affiliation': 'Department of Radiation Oncology, University of Toronto and Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Reiter', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Department of Radiation Oncology, University of Toronto and Odette Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Himu', 'Initials': 'H', 'LastName': 'Lukka', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sussman', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada. Electronic address: twhelan@hhsc.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.049'] 135,32335133,Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial.,"BACKGROUND & AIMS Telemedicine can be used to monitor determinants and outcomes of patients with chronic diseases, possibly increasing the quality and value of care. Telemedicine was found to reduce outpatient visits and hospital admissions for patients with inflammatory bowel diseases (IBD). We performed a full economic evaluation of telemedicine interventions in patients with IBD, comparing the cost-utility of telemedicine vs standard care. METHODS We performed a randomized trial of 909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands. Patients were randomly assigned to groups that received telemedicine (myIBDcoach; n=465) or standard outpatient care (n=444) and followed for 12 months. Costs were measured from a societal perspective. Direct healthcare costs were based on actual resource use. Indirect costs comprised self-reported hours sick leave from work, intervention costs (annual license fee of €40 per patient [$45]), and utility costs (assessed using EQ5D). Cost-utility and uncertainty were estimated using the non-parametric bootstrapping method. RESULTS Telemedicine resulted in lower mean annual costs of €547/patient [$612] (95% CI, €1029-2143 [$1150-2393]; mean costs of €9481 [$10,587] for standard care and €8924 [$9965] for telemedicine) without changing quality adjusted life years. At the Dutch threshold of €80,000 [$89,335] per quality adjusted life year, the intervention had increased incremental cost-effectiveness over standard care in 83% of replications and an incremental net monetary benefit of €707/patient [$790] (95% CI, €1241-2544 [$1386-2841]). CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD. This self-management tool enables continuous registration of quality indicators and (patient-reported) outcomes and might help reorganize IBD care toward value-based healthcare. ClinicalTrials.gov no: NCT02173002.",2020,"CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD.","['patients with IBD', 'patients with chronic diseases', 'patients with inflammatory bowel diseases (IBD', '909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands', 'Patients']","['Telemedicine-directed Specialized vs Standard Care', 'Telemedicine', 'telemedicine (myIBDcoach; n=465) or standard outpatient care', 'telemedicine interventions', 'telemedicine', 'telemedicine vs standard care']","['utility costs', 'mean annual costs', 'incremental cost-effectiveness', 'Cost-utility and uncertainty', 'outpatient visits and hospital admissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",909.0,0.11441,"CONCLUSIONS Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD.","[{'ForeName': 'Marin J', 'Initials': 'MJ', 'LastName': 'de Jong', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Rheumatology, Maastricht; Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'van der Meulen-de Jong', 'Affiliation': 'Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden.'}, {'ForeName': 'Mariëlle J', 'Initials': 'MJ', 'LastName': 'Romberg-Camps', 'Affiliation': 'Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Ad A', 'Initials': 'AA', 'LastName': 'van Bodegraven', 'Affiliation': 'Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Nofel', 'Initials': 'N', 'LastName': 'Mahmmod', 'Affiliation': 'St Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Markus', 'Affiliation': ""Dutch Crohn's and Colitis Organisation, CCUVN, Woerden.""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Dijkstra', 'Affiliation': 'University Medical Centre Groningen, Department of Gastroenterology and Hepatology, Groningen.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht; Maastricht University, Department of Methodology and Statistics, Maastricht, Netherlands.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Tubergen', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Rheumatology, Maastricht; Maastricht University Medical Centre+, CAPHRI - Care and Public Health Research Institute, Maastricht.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Masclee', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Zuyderland Medical Centre, Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Sittard-Geleen.'}, {'ForeName': 'Daisy M', 'Initials': 'DM', 'LastName': 'Jonkers', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Pierik', 'Affiliation': 'Maastricht University Medical Centre+, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht; Maastricht University Medical Centre+, NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht. Electronic address: m.pierik@mumc.nl.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.038'] 136,32289741,Dulaglutide reduces binge episodes in type 2 diabetic patients with binge eating disorder: A pilot study.,"AIMS Binge eating disorder (BED) is the most common eating disorder in the United States and Europe and is associated with obesity and type 2 diabetes (T2D). Presence and severity of BED have been associated with worse metabolic control and greater BMI in T2D patients. Glucagon Like Peptide-1 (GLP1) receptors are present in central nervous system areas involved in appetite regulation and treatment with GLP-1 receptor agonists modulates appetite and reward-related brain areas in humans. We evaluated the effects of treatment with dulaglutide on eating behavior in T2D outpatients with BED. METHODS This was a pilot open label, prospective controlled study. Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED. Patients were randomly assigned to receive either Dulaglutide 1,5 mg/sett or Gliclazide 60 mg for 12 weeks. We evaluated baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes after treatment. A multivariate linear regression model was used to verify the association between Δ BES from baseline with Δ Hba1c and variation of anthropometric parameters after treatment. RESULTS After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide. Reduction in BES was associated with reduction in body weight (p < 0.0001) and HbA1c (p = 0.033). CONCLUSION Dulaglutide treatment reduces binge eating behaviour in T2D patients with BED.",2020,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","['T2D patients', 'type 2 diabetic patients with binge eating disorder', 'T2D outpatients with BED', 'Inclusion criteria were: Age ≤65, HbA1c between 7.5 and 9% on metformin therapy alone, normal renal function and diagnosis of BED', 'T2D patients with BED']","['Dulaglutide 1,5 mg/sett or Gliclazide', 'Dulaglutide treatment', 'dulaglutide', 'Dulaglutide', 'gliclazide']","['BMI', 'percentage fat mass', 'binge eating behaviour', 'binge episodes', 'baseline binge eating scale score (BES), weight, BMI, percentage fat mass, HbA1c and their changes', 'Reduction in BES', 'eating behavior', 'body weight']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451027', 'cui_str': 'Binge eating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]",,0.0375975,"After 12 weeks patients treated with dulaglutide had grater reduction of binge eating behaviour (p < 0.0001), body weight (p < 0,0001), BMI (p < 0.0001), percentage fat mass (p < 0.0001) and HbA1c (p = 0.009) than patients treated with gliclazide.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Da Porto', 'Affiliation': 'Internal Medicine, University of Udine, Italy. Electronic address: daporto.andrea@gmail.com.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Casarsa', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Catena', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Cavarape', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Sechi', 'Affiliation': 'Internal Medicine, University of Udine, Italy.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.03.009'] 137,32305825,Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery.,"OBJECTIVES Pregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS). PATIENTS AND METHODS 30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery. RESULTS In the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group. CONCLUSION Pregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.",2020,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","['patients with relapsing remitting multiple sclerosis (RRMS', '30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017', 'women with multiple sclerosis (MS']",['pregnancy and exclusive breastfeeding'],"['total number of relapses', 'Expanded Disability Status Scale (EDSS', 'relapse rate and disability', 'mean EDSS', 'multiple sclerosis relapse rate and degree of disability', 'rate of relapse and degree of disability', 'mean number of relapses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",30.0,0.0139494,"At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Mohaddeseh', 'Initials': 'M', 'LastName': 'Nouri', 'Affiliation': 'Hamedan University of Medical Sciences, Hamedan, Iran.'}, {'ForeName': 'Abdorreza Naser', 'Initials': 'AN', 'LastName': 'Moghadasi', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.ghaffari@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105829'] 138,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074'] 139,32200304,Effects of sleep restriction on subjective and physiological variables in middle-aged Korean adults: an intervention study.,"BACKGROUND Adequate sleep is crucial for normal functioning. However, most people, including middle-aged adults of reproductive age, show a marked reduction in their sleep duration. Thus, sleep is a major issue that should be addressed in health management. We investigated the effects of short-term sleep restriction on subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP]) in middle-aged adults, the recovery of these parameters after rest, and the associations between parameters. METHODS A total of 118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled. Participants underwent a 4-h sleep restriction per day for 3 day at a hospital, and then returned to their daily lives to take four days of rest. A questionnaire and blood test were administered before and after sleep restriction, and after the recovery period, to assess subjective and physiological parameters. RESULTS After sleep restriction, sleepiness, fatigue, and stress significantly increased compared to baseline. Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline. After the recovery phase, all parameters were restored to levels similar to baseline levels. Changes in each parameter were mutually associated; fatigue and sleepiness had the strongest association. CONCLUSION Our results suggest that even a short period of sleep restriction can have an adverse impact on psychological and physiological stress parameters in middle-aged adults, and that adequate rest and sleep are needed to restore them to normal levels.",2020,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","['118 healthy adults (59 men, 59 women), aged 35-44 years, and without sleep problems, were enrolled', 'middle-aged Korean adults', 'middle-aged adults']","['sleep restriction', 'short-term sleep restriction']","['sleepiness, fatigue, and stress', 'Cortisol and TSH', 'subjective parameters (sleepiness, stress, fatigue) and physiological parameters (cortisol, thyrotropin [TSH], thyroxine [T4], triiodothyronine [T3], C-reactive protein [CRP', 'subjective and physiological variables', 'fatigue and sleepiness']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",118.0,0.0305566,"Cortisol and TSH were elevated after sleep restriction, while T4, T3, and CRP were reduced compared to baseline.","[{'ForeName': 'Younghwa', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Kyungsik', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Siwoo', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea. Electronic address: ifree72@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.006'] 140,32201234,ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer.,"BACKGROUND Many patients with metastatic non-small-cell lung cancer (mNSCLC) experience disease progression after first- and second-line treatment; more treatment options are required for these patients. ARCTIC, a phase III, randomized, open-label study, assessed durvalumab ± tremelimumab versus standard of care (SoC) as ≥ third-line treatment of mNSCLC. PATIENTS AND METHODS ARCTIC comprised two independent sub-studies. Study A: 126 patients with ≥25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1) were randomized (1 : 1) to durvalumab [up to 12 months 10 mg/kg every 2 weeks (q2w)] or SoC. Study B: 469 patients with PD-L1 TC <25% were randomized (3 : 2 : 2 : 1) to durvalumab + tremelimumab (12 weeks durvalumab 20 mg/kg + tremelimumab 1 mg/kg q4w then 34 weeks durvalumab 10 mg/kg q2w), SoC, durvalumab (up to 12 months 10 mg/kg q2w), or tremelimumab (24 weeks 10 mg/kg q4w then 24 weeks q12w). Primary end points: overall survival (OS) and progression-free survival (PFS) for durvalumab versus SoC (study A; descriptive only) and durvalumab + tremelimumab versus SoC (study B). RESULTS Study A: median OS 11.7 (durvalumab) versus 6.8 (SoC) months {hazard ratio (HR) 0.63 [95% confidence interval (CI), 0.42-0.93]}; median PFS 3.8 (durvalumab) versus 2.2 (SoC) months [HR 0.71 (95% CI, 0.49-1.04)]. Study B: median OS 11.5 (durvalumab + tremelimumab) versus 8.7 (SoC) months [HR 0.80 (95% CI, 0.61-1.05); P = 0.109]. Median PFS of 3.5 months for both groups [HR 0.77 (95% CI, 0.59-1.01); P = 0.056]. Treatment-related grade 3/4 adverse events: 9.7% (durvalumab) and 44.4% (SoC; study A) and 22.0% (durvalumab + tremelimumab) and 36.4% (SoC; study B). CONCLUSIONS In heavily pretreated patients with mNSCLC, durvalumab demonstrated clinically meaningful improvements in OS and PFS versus SoC (patients with PD-L1 TC ≥25%); numerical improvements in OS and PFS for durvalumab + tremelimumab versus SoC were observed (patients with PD-L1 TC <25%). Safety profiles were consistent with previous studies. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT02352948.",2020,"Median PFS of 3.5 months for both groups [HR 0.77 (95% CI, 0.59-1.01); P = 0.056].","['126 patients with ≥25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1', '469 patients with PD-L1 TC <25', 'metastatic non-small-cell lung cancer', 'ARCTIC comprised two independent sub-studies', 'patients with metastatic non-small-cell lung cancer (mNSCLC']","['durvalumab 10 mg/kg q2w), SoC, durvalumab', 'durvalumab ± tremelimumab versus standard of care (SoC', 'durvalumab', 'durvalumab\xa0+ tremelimumab (12 weeks durvalumab 20 mg/kg\xa0+ tremelimumab 1 mg/kg', 'tremelimumab']","['Median PFS', 'OS and PFS', 'overall survival (OS) and progression-free survival (PFS) for durvalumab versus SoC (study A; descriptive only) and durvalumab\xa0+ tremelimumab versus SoC (study B']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}]",469.0,0.142441,"Median PFS of 3.5 months for both groups [HR 0.77 (95% CI, 0.59-1.01); P = 0.056].","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France. Electronic address: David.PLANCHARD@gustaveroussy.fr.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Orlov', 'Affiliation': 'Pavlov State Medical University, St Petersburg, Russia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Fischer', 'Affiliation': 'Lungenklinik Loewenstein, Löwenstein, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mandziuk', 'Affiliation': 'Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marquez-Medina', 'Affiliation': 'Arnau de Vilanova University Hospital, Lleida, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi, Orbassano, Italy.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Takeda', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Soo', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Florida Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'May', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Scheuring', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.02.006'] 141,32380132,Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on patient perception and denture quality.,"OBJECTIVES To evaluate the effectiveness of CCDs produced by two impression procedures for the mandibular ridge, in patients with severe mandibular atrophy. METHODS Fifty-two completely edentulous patients with severely resorbed mandibles were randomly allocated into two groups according to the impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether). Assessments of oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction were performed by using validated questionnaires. Denture quality was evaluated by means of functional tests. RESULTS Regardless of the technique, participants reported better OHRQoL (P < 0.001) in both follow-up periods (3 and 6 months after denture delivery), and groups resulted in similar OHIP-EDENT scores in its different domains (P > 0.05). Between-group differences were insignificant for general satisfaction (3 months, P = 0.699, 6 months, P = 0.392), as well as for aspects such as esthetics, comfort, mastication, speech, and prosthesis retention (P > 0.05). Overall clinical quality of the CCDs (P = 0.383) was similar between-group, as well as in specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures (P > 0.05). CONCLUSIONS Mandibular CCDs based on a single impression technique showed quality levels comparable to those generated by a two-step impression, both from the patient and clinician perspective. CLINICAL SIGNIFICANCE A simplified impression technique which eliminates the secondary impression can provide CCDs of good clinical quality, which influences the OHRQoL, and satisfaction in the same extent they would by a two-step procedure, even for patients with severely reabsorbed mandibular ridges. (ClinicalTrials.gov: NCT02339194).",2020,"Regardless of the technique, participants reported better OHRQoL","['patients with severely reabsorbed mandibular ridges', 'patients with severe mandibular atrophy.\nMETHODS\n\n\nFifty-two completely edentulous patients with severely resorbed mandibles']","['impression procedure of the mandibular ridge: SI - single impression (stock tray and irreversible hydrocolloid); TI - two-step impression (custom tray, border molding with compound, and polyether', 'CCDs']","['patient perception and denture quality', 'oral health related quality of life (OHRQoL, primary outcome) and denture satisfaction', 'specific aspects - interocclusal distance, occlusion, articulation, retention of the maxillary denture, and stability of both maxillary and mandibular dentures', 'Overall clinical quality of the CCDs', 'quality levels', 'Denture quality', 'general satisfaction', 'OHRQoL', 'similar OHIP-EDENT scores', 'esthetics, comfort, mastication, speech, and prosthesis retention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C0205198', 'cui_str': 'Compound'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C3178965', 'cui_str': 'Prosthesis Retention'}]",52.0,0.0541727,"Regardless of the technique, participants reported better OHRQoL","[{'ForeName': 'Ivo S', 'Initials': 'IS', 'LastName': 'Albuquerque', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Rômulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil. Electronic address: romuloregis@hotmail.com.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, 2001 McGill College Ave, Suite 500, Montreal, Quebec. Canada.'}, {'ForeName': 'Kelvin F', 'Initials': 'KF', 'LastName': 'Gurgel', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Paulo Gb', 'Initials': 'PG', 'LastName': 'Silva', 'Affiliation': 'Department of Dental Clinic, Division of Oral Pathology, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará (FFOE-UFC), Fortaleza, Brazil.'}, {'ForeName': 'Livia M S', 'Initials': 'LMS', 'LastName': 'Pinto-Fiamengui', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Alexandre Baraúna St. 949, Rodolfo Teófilo, Fortaleza, Ceará, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103356'] 142,32380135,Measurement of eroded dentine tubule patency and roughness following novel dab-on or brushing abrasion.,"OBJECTIVES To investigate the effect of dab-on or brushing of stannous-fluoride SnF2 or sodium-fluoride NaF dentifrice on eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP). METHODS 75-polished human dentine samples were prepared and eroded in agitated 6% citric acid to expose patent tubules and 'initiate' DH. Samples were randomly allocated into 5 intervention groups; artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5). Samples underwent three cycles of intervention followed by further acid challenge. Patent tubules, likely to cause DH clinically, were measured using validated biocomputational methods with CLSM images of dentine surfaces taken baseline and post-intervention. Randomised samples (n = 15, 20 %) were investigated using AFM, EDX and SEM to study surface and sub-surface tubular occlusion. Dentine surface and inter-tubular roughness were measured using CP and AFM respectively. RESULTS At baseline, mean tubule patency in all samples was 216 (SD 58) with no significant inter-group differences. Post-intervention, the mean patency was 220 (40) and 208 (35) in groups 1 and 2 respectively (p ≥ 0.06), but decreased to 62 (41), 62 (21) and 63 (19) in groups 3, 4 and 5 respectively (p < 0.0001). Patency was confirmed using AFM, SEM and EDX. SnF2 interventions created greater sub-surface occlusion (p < 0.01), and increased CP surface roughness (p = 0.015). Significant negative correlation (-0.6) existed between CP surface roughness and tubule patency (p = 0.009). CONCLUSIONS Dab-on with NaF and SnF2 or brushing with SnF2 reduces DH in eroded dentine with ongoing acid challenges. Contacting surface roughness measures indicate risk of DH. CLINICAL SIGNIFICANCE Dab-on is a convenient supplementary method of dentifrice application to reduce DH; it beneficially avoids brushing post-erosion or overzealous brushing, enables re-establishment of an appropriate brushing regime post-DH and supports oral health. Significant modes of action of SnF2 in reducing DH are revealed. Finally, CP roughness measures provide indication of dentine lesions that may cause DH clinically.",2020,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).",['75-polished human dentine samples were prepared and eroded in agitated 6'],"[""citric acid to expose patent tubules and 'initiate' DH"", 'NaF dentifrice', 'stannous-fluoride SnF2 or sodium-fluoride', 'artificial saliva control (1); electric tooth-brushing with NaF (2) or SnF2 (3), and dab-on application of NaF (4) or SnF2 (5']","['CP surface roughness and tubule patency', 'mean patency', 'eroded dentine tubule patency, surface and inter-tubular dentine roughness, using Confocal-Laser-Scanning-Microscopy (CLSM), Atomic-Force-Microscopy (AFM), Energy-Dispersive-X-ray-Spectroscopy (EDX), Scanning-Electron-Microscopy (SEM) and Contact-Profilometry (CP', 'sub-surface occlusion', 'mean tubule patency', 'CP surface roughness', 'Dentine surface and inter-tubular roughness']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}]","[{'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0012411', 'cui_str': '4-dimethylaminoazobenzene'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C2699997', 'cui_str': 'Energy Dispersive X-Ray Fluorescence Spectroscopy'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",,0.0311758,"SnF2 interventions created greater sub-surface occlusion (p < 0.01), and CP surface roughness (p = 0.015).","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Olley', 'Affiliation': 'Cardiff University, School of Dentistry, University Hospital Wales, Heath Park, Cardiff CF14 4XY, UK; Faculty of Dentistry, Oral and Craniofacial Sciences, Kings College London, London, UK. Electronic address: olleyr1@cardiff.ac.uk.'}, {'ForeName': 'Basim M', 'Initials': 'BM', 'LastName': 'Mohsen', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: bmmohsen1@sheffield.ac.uk.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Alhaij', 'Affiliation': 'Dental School, University of Dundee, Dundee, UK. Electronic address: s.alhaij@dundee.ac.uk.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Appleton', 'Affiliation': 'School of Life Sciences, University of Dundee, Dundee, UK. Electronic address: P.L.Appleton@dundee.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103358'] 143,32384727,Benefits of a Three-Day Bamboo Forest Therapy Session on the Physiological Responses of University Students.,"Studies have indicated that natural environments have the potential to improve the relationship between a stressful life and psychological well-being and physical health. Forest therapy has recently received widespread attention as a novel solution for stress recovery and health promotion. Bamboo is an important forest type in many countries, especially in East and Southeast Asia and in African countries. Bamboo is widespread throughout southwestern China. Empirical field research on the physiological effects of bamboo forest therapy is currently lacking. To explore the benefits of bamboo forest therapy on the physiological responses of university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each). Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS). During the testing period, all participants were asked to view the landscape for 15 min in the morning and then walk in the testing area for 15 min in the afternoon. Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2) were measured as the physiological indexes, and the semantic differential method (SDM) questionnaire was completed for the environmental satisfaction evaluation. The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites. The three-day bamboo forest therapy session improved the physiological well-being of university students. First, the blood pressure and heart rate of the university students decreased, and the SpO2 increased, after the three-day viewing and walking activities of the three-day bamboo forest therapy session. The viewing activities had a more pronounced effect on decreased heart rate in university students. Additionally, three-day bamboo forest therapy had a positive impact on decreased systolic blood pressure and heart rate in the university students, and it was significantly decreased in females, while peripheral oxygen saturation (SpO2) remained relatively low. Finally, compared with the urban site (CS), the bamboo forest sites effectively improved the university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators. These findings provide scientific evidence that a three-day bamboo forest therapy session can increase positive physiological responses. The potential for a longer-term effect on human physiological health requires further investigation.",2020,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","['university students, 120 university volunteers between the ages of 19 and 24 participated in this study (60 males and 60 females) and were randomly divided into four groups of equal size (15 males and 15 females in each', 'Four sites were selected for the experiment, including two natural bamboo forests (YA and YB), a bamboo forest park (DJY), and an urban environment (CS', 'University Students', 'university students']",['bamboo forest therapy'],"['Blood pressure (BP), heart rate (HR), and peripheral oxygen saturation (SpO2', ""university students' physiological state of health, decreased their physical pressure, and stabilized their physiological indicators"", 'semantic differential method (SDM) questionnaire', 'heart rate', 'blood pressure and heart rate of the university students', 'peripheral oxygen saturation (SpO2', 'systolic blood pressure and heart rate', 'positive physiological responses']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",120.0,0.0259646,"The SDM for the subjective environmental evaluation differed significantly among the university students; they obtained a better environmental experience, in terms of sensory perception, atmosphere, climate, place, and space, in the bamboo forest sites.","[{'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bingyang', 'Initials': 'B', 'LastName': 'Lyu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Songyuan', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu 611130, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17093238'] 144,32386077,The effect of tailored consumer medicine information on patients with type 2 diabetes mellitus: A randomised controlled interventional study.,"INTRODUCTION In patients with diabetes, better health communication is associated with better health outcomes including medication adherence and glycaemic control. The conventional patient information leaflet does not consider the cultural and behavioral perspectives of diverse patient populations. Consumer medicine information (CMI) is a written information about the prescription drugs developed by organisations or individuals other than a drug manufacturer that is intended for distribution to consumers at the time of medication dispensing. OBJECTIVE This study aimed to evaluate the impact of CMI on medication adherence and glycaemic control among patients with type 2 diabetes in Qatar. METHODS We developed and customised CMI for all the anti-diabetic medications used in Qatar. A randomised controlled trial in which the intervention group patients (n = 66) received the customised CMI with usual care, while the control group patients (n = 74) received usual care only, was conducted. Self-reported medication adherence and haemoglobin A 1c (HbA 1c ) were the primary outcome measures. Glycaemic control and medication adherence parameters were measured at baseline, 3 months, and 6 months in both groups. Medication adherence was measured using the 8-item Morisky Medication Adherence Scale (MMAS-8). RESULTS Although the addition of CMI resulted in better glycaemic control, this did not reach statistical significance, possibly because of the short-term follow-up. The median MMAS-8 score improved from baseline (6.6 [IQR = 1.5]) to 6-month follow-up (7.0 [IQR = 1.00]) in the intervention group. In addition, there was a statistically significant difference between the intervention and the control groups in terms of MMAS-8 score at the third visit (7.0 [IQR = 1.0]) vs 6.5 (IQR = 1.25; P-value = .010). CONCLUSION CMI for anti-diabetic medications when added to usual care has the potential to improve medication adherence and glycaemic control among patients with type 2 diabetes. Therefore, providing better health communication and CMI to patients with diabetes is recommended.",2020,"In addition, there was a statistically significant difference between the intervention and control groups in terms of MMAS-8 score at the third visit [7.0 (IQR=1.0) vs. 6.5 (IQR=1.25; p-value= 0.010). ","['patients with T2DM', 'patients with diabetes in Qatar', 'Patients with Type 2 Diabetes Mellitus', 'group patients (n=66) received the']","['customized CMI with usual care, while the control group patients (n=74) received usual care', 'Consumer Medicine Information', 'CMI', 'intervention', 'Consumer medicine information (CMI']","['Medication adherence', '8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence and glycemic control', 'Glycemic control and medication adherence parameters', 'median MMAS-8 score', 'Self-reported medication adherence and hemoglobin', 'MMAS-8 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0511414,"In addition, there was a statistically significant difference between the intervention and control groups in terms of MMAS-8 score at the third visit [7.0 (IQR=1.0) vs. 6.5 (IQR=1.25; p-value= 0.010). ","[{'ForeName': 'Emad E', 'Initials': 'EE', 'LastName': 'Munsour', 'Affiliation': 'Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awaisu', 'Affiliation': 'Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Mohamed Azmi A', 'Initials': 'MAA', 'LastName': 'Hassali', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Abdoun', 'Affiliation': 'Pharmacy Department, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dabbous', 'Affiliation': 'Diabetes/Endocrinology, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noran', 'Initials': 'N', 'LastName': 'Zahran', 'Affiliation': 'Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar.'}, {'ForeName': 'Hamda', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Diabetes/Endocrinology, National Diabetes Center, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.'}]",International journal of clinical practice,['10.1111/ijcp.13527'] 145,32391524,Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS).,"Background Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change. Methods COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders' fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. Discussion COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors. Trial registration This study was registered in ClinicalTrials.gov (NCT03799432) on January 10, 2019 (last updated August 5, 2019).",2020,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"['community mental health organizations', 'January 10, 2019 (last updated August 5, 2019']",[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]",[],[],,0.0998777,The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment.,"[{'ForeName': 'Byron J', 'Initials': 'BJ', 'LastName': 'Powell', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Haley', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sheila V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Amaya-Jackson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Glienke', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Mellicent', 'Initials': 'M', 'LastName': 'Blythe', 'Affiliation': 'North Carolina Child Treatment Program, Center for Child and Family Health, Durham, NC, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lengnick-Hall', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'McCrary', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Lewis', 'Affiliation': 'MacColl Center for Health Care Innovation, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Aarons', 'Affiliation': 'Department of Psychiatry, Child and Adolescent Services Research Center, University of California San Diego School of Medicine, San Diego, CA, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Wells', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, Eugene, OR, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McKay', 'Affiliation': 'Brown School, Washington University in St. Louis, One Brookings Drive, Campus Box 1196, St. Louis, MO 63130, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Implementation science communications,['10.1186/s43058-020-00009-5'] 146,32387531,The effect of presenting relative calorie information on calories ordered.,"In this research, we tested the effect of a novel method of presenting calorie information-highlighting relative differences in calories among ingredients. We conducted an online hypothetical food choice experiment where 633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables. Each participant was randomly assigned to one of four calorie information conditions: 1) a condition in which no information about calories was provided, 2) a condition in which calorie information was provided for each ingredient, 3) a condition in which calorie information was presented relative to the highest calorie item, and 4) a condition in which calorie information was presented relative to the lowest calorie item. Participants in the high- and low-calorie reference conditions ordered between 32 and 36 fewer calories per sandwich than participants in the no-calorie information control condition (p ≤ 0.04). Calories ordered by participants in the per-item calorie condition were not significantly different than the control. Presenting relative calorie or other nutritional information to make health-related trade-offs more salient may guide consumers to make healthier choices.",2020,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"['633 participants selected the ingredients for a sandwich from five categories: meat/protein, cheese, spread/dressing, bread, and vegetables']","['condition in which no information about calories was provided, 2) a condition in which calorie information']",[],"[{'cui': 'C4543503', 'cui_str': 'Sandwich'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",[],633.0,0.0417974,Calories ordered by participants in the per-item calorie condition were not significantly different than the control.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, University of Nebraska-Lincoln, 314A Filley Hall, Lincoln, NE, 68583, USA. Electronic address: cgustafson6@unl.edu.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Zeballos', 'Affiliation': 'USDA Economic Research Service, Food Economic Division, Washington, D.C, USA. Electronic address: eliana.zeballos@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104727'] 147,32389574,"Pharmacokinetics and pharmacodynamics of JR-051, a biosimilar of agalsidase beta, in healthy adults and patients with Fabry disease: Phase I and II/III clinical studies.","Fabry disease is a rare X-linked lysosomal disease, in which mutations in the gene encoding α-galactosidase A result in progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs including the skin, kidney, and heart, often leading to life-threatening conditions. Enzyme replacement therapy is currently the standard therapy for the disease, to which two α-galactosidase A formulations have been approved: agalsidase α (Replagal®, Shire) and agalsidase β (Fabrazyme®, Sanofi). We have recently developed a biosimilar of agalsidase β, JR-051, and investigated its pharmacokinetics and pharmacodynamics to assess its bioequivalence to agalsidase β. In a randomized phase I study, healthy adult male volunteers were treated with JR-051 or agalsidase β and the pharmacokinetics of the drugs were compared. The ratio of geometric means (90% confidence interval [CI]) of the AUC 0 - 24 and C max for JR-051 over agalsidase β were 0.91 (0.8294, 1.0082) and 0.90 (0.7992, 1.0125), respectively. In a 52-week, single-arm, phase II/III study, patients with Fabry disease switched therapy from agalsidase β to JR-051 to evaluate its pharmacodynamics. The mean (95% CI) plasma GL-3 concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.03 (0.91, 1.15) and 0.96 (0.86, 1.06), respectively, which were within the pre-determined bioequivalence acceptance range (0.70, 1.43). The mean (95% CI) plasma globotriaosylsphingosine (lyso-GL-3) concentrations at weeks 26 and 52 relative to pre-JR-051 administration were 1.07 (0.92, 1.23) and 1.13 (1.03, 1.22), respectively. Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified. In conclusion, these studies demonstrated bioequivalence of JR-051 to agalsidase β in terms of its pharmacokinetics and pharmacodynamics. JR-051 offers a potential new treatment option for patients with Fabry disease.",2020,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","['patients with Fabry disease', 'healthy adult male volunteers', 'healthy adults and patients with Fabry disease']","['JR-051', 'Enzyme replacement therapy', 'JR-051 or agalsidase β']","['ratio of geometric means', 'plasma globotriaosylsphingosine (lyso-GL-3) concentrations', 'Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators', 'plasma GL-3 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002986', 'cui_str': ""Fabry's disease""}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0082711', 'cui_str': 'globotriaosyl lysosphingolipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0337138,"Estimated glomerular filtration rate and left ventricular mass index, as renal and cardiac function indicators, showed no notable changes from baseline throughout the study period, and no new safety concerns were identified.","[{'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Faculty of Life Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan. Electronic address: nakamura@kumamoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kawashima', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Tozawa', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Yamaoka', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Tatsuyoshi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Development Division, JCR Pharmaceuticals, 2-4 Kasuga-cho, Ashiya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Research Division, JCR Pharmaceuticals, 2-2-9 Murotani, Nishi-ku, Kobe, Japan.'}, {'ForeName': 'Torayuki', 'Initials': 'T', 'LastName': 'Okuyama', 'Affiliation': 'National Centre for Child Health and Development, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Eto', 'Affiliation': 'Advanced Clinical Research Centre & Asian Lysosome Storage Disorder Centre, Institute of Neurological Disorders, Japan.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.04.003'] 148,32397235,Effects of a Motion Seat System on Driver's Passive Task-Related Fatigue: An On-Road Driving Study.,"Passive task-related (TR) fatigue caused by monotonous driving can negatively affect driving safety by impairing driver alertness and performance. This study aims to evaluate the effectiveness of a motion seat system on the driver's passive TR fatigue in terms of driving performance, physiological response, and subjective fatigue by using automotive and physiological sensors those applicable to on-road driving environment. Twenty drivers (5 females and 15 males; age = 38.5 ± 12.2) with more than two years of driving experience participated in an on-road experiment with two driving conditions: driving in the static seat condition during the first half of the driving session and then in the static (static-static, SS) or motion seat (static-motion, SM) condition during the second half. The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals. The drivers rated significantly lower subjective state changes of overall fatigue, mental fatigue, passive TR fatigue, drowsiness, and decreased concentration in the SM condition than those in the SS condition. The findings of the study support the use of a motion seat system can be an effective countermeasure to reduce passive TR fatigue.",2020,"The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals.","['Twenty drivers (5 females and 15 males; age = 38.5 ± 12.2) with more than two years of driving experience participated in an on-road experiment with two driving conditions: driving in the static seat condition during the first half of the driving session and then in the static (static-static, SS) or motion seat (static-motion, SM) condition during the second half', ""Driver's Passive Task-Related Fatigue""]","['motion seat system', 'Motion Seat System']","['Passive task-related (TR) fatigue', 'subjective state changes of overall fatigue, mental fatigue, passive TR fatigue, drowsiness, and decreased concentration in the SM condition', 'passive TR fatigue']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C1444752', 'cui_str': 'Status during'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443172', 'cui_str': 'Changed status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0139913,"The SM condition showed significantly lower passive TR fatigue by 4.4~56.5% compared to the SS condition in terms of the standard deviation of velocity, percentage of eyelid closure rate (PERCLOS), and the ratio of low- to high-frequency power (LF/HF) of electrocardiography signals.","[{'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Minjae', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Hayoung', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}, {'ForeName': 'Sunwoo', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Body Test Team 3, Hyundai Motor Company, Hwaseong 18280, Korea.'}, {'ForeName': 'Heecheon', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Industrial and Management Engineering, Pohang University of Science and Technology, Pohang 37673, Korea.'}]","Sensors (Basel, Switzerland)",['10.3390/s20092688'] 149,32335287,Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial.,"Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving-a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.",2020,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","['human participants', 'Adult smokers', 'smoking cessation']","['isradipine', 'Isradipine', 'isradipine or placebo']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.135599,"In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Cara C', 'Initials': 'CC', 'LastName': 'Young', 'Affiliation': 'School of Nursing, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Gebhardt', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perrone', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Morikawa', 'Affiliation': 'Department of Neuroscience, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Austin, TX, United States.; Institute for Mental Health Research, The University of Texas at Austin, Austin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106013'] 150,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777'] 151,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086'] 152,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI). DESIGN Controlled laboratory study. PARTICIPANTS Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm. MAIN OUTCOME MEASURES DFROM was assessed in a straight and bent-leg position. RESULTS No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. CONCLUSIONS Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. ","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2. ","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001'] 153,32388274,Effects of seafood consumption on mercury exposure in Norwegian pregnant women: A randomized controlled trial.,"BACKGROUND Seafood provides nutrients that are important for optimal development of the unborn child. However, seafood is also a source of contaminants including mercury (Hg) and methylmercury (MeHg) that may have adverse effects on neurodevelopment of the fetus. Humans are predominantly exposed to MeHg through seafood consumption, however, levels of MeHg vary considerably between species. OBJECTIVES Investigate, in a randomized controlled trial (RCT) during pregnancy, if an increased intake of Atlantic cod (Gadus morhua), a fish species with relatively low levels of MeHg contamination, influences total hair Hg (THHg) concentrations in humans. METHODS Pregnant women (n = 137) were enrolled in the RCT ""Mommy's Food"" (2016-2017), which was designed to increase iodine status. Participants were randomly assigned to intervention (400 g of cod fillets per week) or control (continued habitual diet) groups for 16 weeks (gestational week 20-36). THHg concentrations were measured at baseline and post-intervention using thermal decomposition, amalgamation, and atomic absorption spectrophotometry (US EPA method 7473). The trial is registered in ClinicalTrials.gov, NCT02610959. RESULTS Post-intervention, the intervention group had median (inter-quartile range) THHg concentrations of 554 (392-805) µg/kg, and the control group 485 (341-740) µg/kg (p = 0.186). When adjusting for baseline THHg concentrations, there was a significant difference between the groups in those participants with baseline THHg concentrations below 534 µg/kg. Post-intervention, 8% of the study population exceeded the US EPA reference dose in hair (1,000 µg/kg) (intervention group: n = 6, control group: n = 4). CONCLUSION THHg concentrations were generally low in both study groups of pregnant women, despite the relatively high seafood intake. While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.",2020,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","['Pregnant women (n\u202f=\u202f137', 'Norwegian pregnant women', 'humans']","['RCT', 'seafood consumption', 'intervention (400\xa0g of cod fillets per week) or control (continued habitual diet']","['total hair Hg (THHg) concentrations', 'iodine status', 'THHg concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",7473.0,0.204374,"While the intervention with 400 g of cod per week slightly increased THHg concentrations, it did not lead to an increase in number of subjects exceeding the US EPA reference dose; a dose level at which no adverse effects are expected to occur over a period of lifetime exposure.","[{'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway. Electronic address: synnoeve.naess@hi.no.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Bank', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway; University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Josef D', 'Initials': 'JD', 'LastName': 'Rasinger', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}, {'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research (IMR), 5817 Bergen, Norway.'}]",Environment international,['10.1016/j.envint.2020.105759'] 154,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND Fatigue is one of the most common symptoms in patients with multiple sclerosis (MS). Currently, there is no approved medication for MS-related fatigue. OBJECTIVE In this study, we aim to evaluate the safety and efficacy of memantine for improving fatigue in patients with MS. METHODS This was a pilot randomized, double-blind, placebo-controlled clinical trial. Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria were randomized to receive either memantine (20 mg/day) or placebo and were assessed at baseline and three months after treatment. The change in the severity of fatigue was determined by the Modified Fatigue Impact Scale (MFIS). RESULTS Sixty-four patients were randomly allocated to the memantine (n = 32) and placebo (n = 32) groups. Sixteen patients in the memantine group and 24 patients in the placebo group completed the study. The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702). No serious adverse events were reported, except for dizziness and sedation in four patients in the experimental arm, which resulted in discontinuation. CONCLUSION This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844'] 155,32272255,COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.,"BACKGROUND Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y 12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown. HYPOTHESIS The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose. STUDY DESIGN COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours. CONCLUSIONS The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.",2020,Evidence suggests that administration of crushed tablets of the P2Y 12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"['patients with ST elevation myocardial infarction (STEMI', 'patients with STEMI undergoing primary percutaneous coronary interventions', 'approximately 674 patients presenting with STEMI planned for primary PCI', 'patients presenting with STEMI planned for primary PCI', 'STEMI patients undergoing primary percutaneous coronary intervention (PCI']","['Prasugrel tablets', 'prasugrel crushed tablets']","['death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year', 'bleeding events', 'percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C2710119', 'cui_str': 'prasugrel Oral Tablet'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]",674.0,0.146697,Evidence suggests that administration of crushed tablets of the P2Y 12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI).,"[{'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Maasstad Hospital, Rotterdam; University Medical Center Utrecht, Netherlands. Electronic address: g.vlachojannis@umcutrecht.nl.'}, {'ForeName': 'Rosanne F', 'Initials': 'RF', 'LastName': 'Vogel', 'Affiliation': 'University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Wilschut', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Miguel E', 'Initials': 'ME', 'LastName': 'Lemmert', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Academic Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'van Vliet', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'van der Waarden', 'Affiliation': 'Ambulance Zorg Rotterdam-Rijnmond, Rotterdam, Netherlands.'}, {'ForeName': 'Rutger-Jan', 'Initials': 'RJ', 'LastName': 'Nuis', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paradies', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Group, Groupe Hospitalier Pitie-Salpetriere Hospital (AP-HP), Paris, France.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Mitchell W', 'Initials': 'MW', 'LastName': 'Krucoff', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Maasstad Hospital, Rotterdam.'}]",American heart journal,['10.1016/j.ahj.2020.03.005'] 156,32305650,"The impact of an educational video about radiotherapy and its toxicities in head and neck cancer patients. Evaluation of patients' understanding, anxiety, depression, and quality of life.","OBJECTIVES Head and neck radiotherapy can cause several toxicities, and its management has important treatment implications. Proper information about treatment is crucial to assist patients by preparing them and enhancing their ability to manage their illness. Thus, this study aimed to verify the impact of an educational video on the improvement of the patient's understanding, satisfaction, quality of life, and influence on their emotional state in different moments of treatment. METHODS A 10 min video about head and neck radiotherapy and its toxicities was produced. A prospective randomized clinical trial was performed in two groups: a control group (n = 65), which received standard verbal and written information, and an experimental group (n = 65), which received standard information and the video. Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU) were applied in four different moments in order to evaluate patients' understanding, anxiety, depression, and quality of life. RESULTS The video improved the understanding of treatment and its side effects. Also, the video group reported better awareness about oral health care during the treatment. Osteoradionecrosis and radiation-related caries were the most unknown side effects. On the other hand, the educational video did not modify the patients' anxiety, depression, and quality of life. All patients reported high satisfaction with the video. CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers. In addition, information about osteoradionecrosis and radiation-related caries must be reinforced to patients.",2020,"CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.",['head and neck cancer patients'],"['standard verbal and written information, and an experimental group (n\xa0=\xa065), which received standard information and the video', 'educational video about radiotherapy', 'educational video']","['anxiety, depression, and quality of life', 'Appropriated questionnaires (HADS, UW-QOLv4, IRTU, and Post-RTU', 'awareness about oral health care', ""patients' anxiety, depression, and quality of life""]","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0257791,"CONCLUSIONS Audiovisual tools may improve patients' understanding of radiotherapy and were shown to be a useful tool when used in association with verbal and written information in cancer centers.","[{'ForeName': 'Diego Tetzner', 'Initials': 'DT', 'LastName': 'Fernandes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Prado-Ribeiro', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Renata Lucena', 'Initials': 'RL', 'LastName': 'Markman', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Morais', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil; Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Moutinho', 'Affiliation': 'Department of Radiology and Oncology, Faculdade de Medicina, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Juliana Ono', 'Initials': 'JO', 'LastName': 'Tonaki', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Thaís Bianca', 'Initials': 'TB', 'LastName': 'Brandão', 'Affiliation': 'Dental Oncology Service, Instituto do Câncer do Estado de São Paulo, ICESP-FMUSP, São Paulo, Brazil.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Oral Pathology and Medicine Research Group, Department of Basic Biomedical Sciences, Faculty of Health Sciences, Universidad de Talca, Chile.'}, {'ForeName': 'Alan Roger', 'Initials': 'AR', 'LastName': 'Santos-Silva', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Márcio Ajudarte', 'Initials': 'MA', 'LastName': 'Lopes', 'Affiliation': 'Oral Diagnosis Department, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, São Paulo, Brazil. Electronic address: malopes@fop.unicamp.br.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104712'] 157,32205017,Antitumor activity of ipatasertib combined with chemotherapy: results from a phase Ib study in solid tumors.,"BACKGROUND This phase Ib study evaluated the safety, tolerability, pharmacokinetics, and preliminary efficacy of the oral AKT inhibitor ipatasertib and chemotherapy or hormonal therapy in patients with advanced or metastatic solid tumors to determine combined dose-limiting toxicities (DLTs), maximum tolerated dose, and recommended phase II doses and schedules. PATIENTS AND METHODS The clinical study comprised four combination treatment arms: arm A (with docetaxel), arm B [with mFOLFOX6 (modified leucovorin, 5-fluorouracil, and oxaliplatin)], arm C (with paclitaxel), and arm D (with enzalutamide). Primary endpoints were safety and tolerability; secondary endpoints were pharmacokinetics, clinical activity per Response Evaluation Criteria in Solid Tumors v1.1, and prostate-specific antigen levels. RESULTS In total, 122 patients were enrolled. Common adverse events were diarrhea, nausea, vomiting, decreased appetite, and fatigue. The safety profiles of the combination regimens were consistent with those of the background regimens, except for diarrhea, hyperglycemia, and rash, which were previously observed with ipatasertib treatment. The only combination DLT across all treatment arms was one event of grade 3 dehydration (ipatasertib 600 mg and paclitaxel). Recommended phase II doses for ipatasertib were 600 mg (and mFOLFOX6) and 400 mg (and paclitaxel), respectively. The maximum assessed dose of ipatasertib 600 mg combined with docetaxel or enzalutamide was well tolerated. Coadministration with enzalutamide (a cytochrome P450 3A inducer) resulted in approximately 50% lower ipatasertib exposure. CONCLUSIONS Ipatasertib in combination with chemotherapy or hormonal therapy was well tolerated with a safety profile consistent with that of ATP-competitive AKT inhibitors. CLINICAL TRIAL NUMBER NCT01362374.",2020,"Coadministration with enzalutamide (a cytochrome P450 3A inducer) resulted in approximately 50% lower ipatasertib exposure. ","['122 patients were enrolled', 'patients with advanced or metastatic solid tumors']","['oral AKT inhibitor ipatasertib and chemotherapy or hormonal therapy', 'enzalutamide', 'ipatasertib combined with chemotherapy', 'docetaxel), arm B [with mFOLFOX6 (modified leucovorin, 5-fluorouracil, and oxaliplatin)], arm C (with paclitaxel), and arm D (with enzalutamide', 'ipatasertib 600 mg combined with docetaxel or enzalutamide']","['safety, tolerability, pharmacokinetics', 'tolerated', 'diarrhea, hyperglycemia, and rash', 'diarrhea, nausea, vomiting, decreased appetite, and fatigue', 'Antitumor activity', 'safety and tolerability; secondary endpoints were pharmacokinetics, clinical activity per Response Evaluation Criteria in Solid Tumors v1.1, and prostate-specific antigen levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",122.0,0.0722243,"Coadministration with enzalutamide (a cytochrome P450 3A inducer) resulted in approximately 50% lower ipatasertib exposure. ","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital, Boston, USA. Electronic address: sisakoff@partners.org.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Molife', 'Affiliation': 'Drug Development Unit, The Royal Marsden and Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Soria', 'Affiliation': 'Department of Cancer Medicine, Institut Gustave Roussy, Université Paris-Saclay, Villejuif, and Université Paris-Sud, Orsay, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'CIBERONC, Department of Medical Oncology, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Division of Hematology/Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Sarasota, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Department of Medicine, California Pacific Medical Center, San Francisco, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Conkling', 'Affiliation': 'Virginia Oncology Associates, US Oncology Research, Norfolk, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sampath', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maslyar', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gendreau', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Musib', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Drug Development Program, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.02.007'] 158,32247220,Surgical resection of macrocystic lymphatic malformations of the head and neck: Short and long-term outcomes.,"BACKGROUND Controversy exists on management of lymphatic malformations, with schools of thought advocating for observation, surgery or sclerotherapy. This study sought to examine outcomes after surgical resection of pediatric cervicofacial macrocystic lymphatic malformations (MLM). METHODS Case series with planned data collection on pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016. For consistency in patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded. The main outcome was complete response rate (CR) and long-term recurrence-free survival (RFS). RESULTS Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian. The majority had de Serres stage I-III (96.8%) affecting the neck (71.4%). Patients were discharged the same day (28.6%), or had a 1 day median length-of-stay (interquartile range (IQR) = 2). Surgical complications included seroma/hematoma (9.5%), transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection (1.6%). On long-term follow-up (median: 12 months, IQR 1-43 months), a single surgery achieved CR in 90.5% of patients. RFS was achieved in 86% of patients in our observation period of up to 15 years. Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively). CONCLUSIONS Surgery is safe and effective as first line treatment for selected MLM. For stage I-III MLM CR and long-term RFS can be achieved with a single surgery. A direct and randomized comparison of treatment modalities is needed.",2020,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively). ","['pediatric patients with cervicofacial MLM who underwent surgical resection at a tertiary referral center for vascular anomalies from January 1995 to June 2016', 'Surgical resection of macrocystic lymphatic malformations of the head and neck', 'patient population analysis, patients who had pre-surgical sclerotherapy or had mixed or microcystic disease were excluded', 'Sixty-three patients who underwent excision of MLM were included, 52.4% were female, 77.8% Caucasian']",[],"['transient nerve weakness (facial nerve, sympathetic chain, or phrenic nerve, 6.3%), and infection', 'seroma/hematoma', 'bilaterality, advanced staging, and partial response', 'complete response rate (CR) and long-term recurrence-free survival (RFS', 'RFS']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2314896', 'cui_str': 'FAMMM'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0158570', 'cui_str': 'Vascular malformation'}, {'cui': 'C0398368', 'cui_str': 'Lymphatic malformation'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0228972', 'cui_str': 'Sympathetic trunk structure'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",63.0,0.129015,"Most patients requiring a second intervention failed within 6-months of initial procedure (4/5 patients, 90%); associated factors included bilaterality, advanced staging, and partial response at first-follow-up (p = 0.0051, 0.0051, and <0.0001, respectively). ","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bonilla-Velez', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA. Electronic address: juliana.bonilla-velez@seattlechildrens.org.""}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Moore', 'Affiliation': 'College of Medicine, University of Arkansas for Medical Sciences, 4301 W Markham St #550, Little Rock, AR, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': 'Department of Pediatrics and Biostatistics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckmiller', 'Affiliation': ""Baylor College of Medicine. 1 Baylor Plaza, Houston, TX, USA; Children's Hospital of San Antonio, 333 N Santa Rosa St, San Antonio, TX, USA.""}, {'ForeName': 'Gresham T', 'Initials': 'GT', 'LastName': 'Richter', 'Affiliation': ""Division of Pediatric Otolaryngology and Center for the Investigation of Congenital Aberrancies of Vascular Development, Arkansas Children's Hospital, 1 Children's Way, Little Rock, AR, USA; Department of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W Markham St #543, Little Rock, AR, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110013'] 159,32335402,Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.,"BACKGROUND Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest. OBJECTIVES Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up. METHODS In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL [""low T""] vs. ≥300 ng/dL [""normal T""]) on rates of pre-specified CV outcomes, using Cox proportional hazards models. RESULTS Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. CONCLUSIONS In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke. CONDENSED ABSTRACT In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The ""low T"" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.",2020,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. ","['2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline', '2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean', 'androgen-deficient men with atherosclerotic cardiovascular disease', 'male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to']",['niacin or placebo plus simvastatin'],"['low baseline testosterone concentrations and increased risk of subsequent CV events', 'CHD death, MI, and stroke composite endpoint', 'Testosterone concentrations and risk of cardiovascular events', 'coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization', 'secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke', 'low baseline testosterone (T) concentrations and subsequent CV outcomes', 'rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007794', 'cui_str': 'Cerebral revascularisation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",2118.0,0.309705,"Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. ","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA. Electronic address: william.boden@va.gov.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Miller', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McBride', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'AbbVie, Chicago, IL.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'McGovern', 'Affiliation': 'VA Boston Healthcare System, Boston University School of Medicine, Boston, MA.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Axio Research, LLC, Seattle, WA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta.'}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Kashyap', 'Affiliation': 'Long Beach VA Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle, WA.'}]",American heart journal,['10.1016/j.ahj.2020.03.016'] 160,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study. OBJECTIVE To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial. METHODS We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale. RESULTS We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39. CONCLUSIONS The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39. ","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39. ","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833'] 161,32302788,Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): A cluster randomized trial of a computerized clinical decision support tool.,"BACKGROUND Clinical decision support (CDS) tools designed to digest, filter, organize, and present health data are becoming essential in providing clinical and cost-effective care. Many are not rigorously evaluated for benefit before implementation. We assessed whether computerized CDS for primary care providers would improve atrial fibrillation (AF) management and outcomes as compared to usual care. METHODS Overall, 203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n = 99) or CDS (n = 104). Providers recruited 1,145 adult patients with AF to participate. The intervention was access to an evidenced-based, point-of-care computerized CDS designed to support guideline-based AF management. The primary efficacy outcome was a composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year. Patients were the units of intention-to-treat analysis. RESULTS No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months. CONCLUSIONS IMPACT-AF rigorously assessed a CDS tool in a highly representative sample of primary care providers and their patients; however, no impact on outcomes was observed. Considering the proliferating use of CDS applications, this study highlights the need for efficacy assessments prior to adoption and clinical implementation.",2020,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months. ","['1,145 adult patients with AF to participate', 'Atrial Fibrillation (IMPACT-AF', '203 primary care providers were recruited, randomized, and then cluster stratified by location (urban, rural) to usual care (n\u202f=\u202f99) or CDS (n\u202f=\u202f104']",['computerized CDS'],"['atrial fibrillation (AF) management and outcomes', 'composite of unplanned cardiovascular hospitalizations and AF-related emergency department visits; the primary safety outcome was major bleeding, both over 1 year', 'primary efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042765', 'cui_str': 'Decision Support, Clinical'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1145.0,0.0610574,"No significant effects on the primary efficacy (130 control, 118 CDS, hazard ratio: 0.98 [95% CI 0.71-1.37], P = .926) or safety (n = 7 usual care, n = 8 CDS, 1.3% total, P = .939) outcomes were observed at 12-months. ","[{'ForeName': 'Jafna L', 'Initials': 'JL', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada; Heart and Stroke Foundation of Nova Scotia Endowed Chair in Cardiovascular Outcomes Research, Halifax, Nova Scotia, Canada. Electronic address: jafna.cox@dal.ca.'}, {'ForeName': 'Ratika', 'Initials': 'R', 'LastName': 'Parkash', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Foster', 'Affiliation': ""Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'MacKillop', 'Affiliation': 'Sydney Primary Care Medical Clinic, Sydney, Nova Scotia, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciaccia', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Shurjeel H', 'Initials': 'SH', 'LastName': 'Choudhri', 'Affiliation': 'Bayer Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hamilton', 'Affiliation': 'QEII Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Nemis-White', 'Affiliation': 'Strive Health Management Consulting Ltd, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Departments of Anesthesia/Pediatrics, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, Centre for Evaluation of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute (PHRI), Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.019'] 162,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440'] 163,32178964,Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer.,"BACKGROUND Metastatic triple-negative breast cancer (mTNBC) is incurable. A key treatment goal is providing palliation while maintaining patients' health-related quality of life (HRQoL). IMpassion130 demonstrated progression-free survival benefit with atezolizumab + nab-paclitaxel (A + nP) versus placebo + nab-paclitaxel (Pl + nP) in first-line treatment of mTNBC patients with programmed death-ligand 1 positive (PD-L1+) tumors. We report data on patient-reported outcomes (PROs), which capture patient perspectives of treatment. PATIENTS AND METHODS Patients with untreated advanced or mTNBC received atezolizumab (840 mg) or placebo every 2 weeks in combination with nab-paclitaxel (100 mg/m 2 ) on days 1, 8, and 15 of each 28-day cycle until progression or intolerance. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and its Breast Cancer Module (QLQ-BR23) on day 1 of each cycle, at end of treatment, and every 4 weeks during 1 year of follow-up. Time-to-deterioration (TTD) in HRQoL (first ≥10-point decrease from baseline lasting two cycles) was a secondary end point. Exploratory end points included TTD in functioning and mean and mean change from baseline scores in HRQoL, functioning, and disease- and treatment-related symptoms. RESULTS Baseline completion of PROs was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained >80% through cycle 20 in intent-to-treat (ITT) and PD-L1+ patients. No differences between arms in median TTD in PD-L1+ patients were observed for HRQoL {hazard ratio (HR) 0.94 [95% confidence interval (CI) 0.69-1.28]} or physical [HR 1.02 (95% CI 0.76-1.37)] or role [HR 0.77 (95% CI 0.57-1.04)] functioning. Mean baseline scores for A + nP versus Pl + nP for HRQoL (67.5 versus 65.0) and physical (82.8 versus 79.4) and role (73.7 versus 71.7) functioning were comparable between arms and throughout the course of treatment, with no clinically meaningful (≥10 point) changes from baseline until patients discontinued treatment. No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, or nausea/vomiting) were observed between arms. Results in ITT patients were similar. CONCLUSIONS A + nP as first-line treatment for mTNBC delayed progression without compromising patients' day-to-day functioning or HRQoL or worsening treatment symptoms. CLINICALTRIAL. GOV IDENTIFIER NCT02425891.",2020,"No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, or nausea/vomiting) were observed between arms.","['metastatic triple-negative breast cancer', 'Patients with untreated advanced or mTNBC received']","['placebo every 2\xa0weeks in combination with nab-paclitaxel', 'atezolizumab plus nab-paclitaxel', 'atezolizumab\xa0+ nab-paclitaxel (A\xa0+ nP) versus placebo\xa0+ nab-paclitaxel (Pl\xa0+ nP', 'atezolizumab']","['treatment symptoms (fatigue, diarrhea, or nausea/vomiting', 'progression-free survival benefit', 'Cancer Quality of Life Questionnaire (QLQ-C30) and its Breast Cancer Module (QLQ-BR23', 'HRQoL {hazard ratio (HR) 0.94', 'Mean baseline scores', 'Time-to-deterioration (TTD) in HRQoL', 'median TTD', 'TTD in functioning and mean and mean change from baseline scores in HRQoL, functioning, and disease- and treatment-related symptoms']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517487', 'cui_str': '0.94 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.365313,"No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, or nausea/vomiting) were observed between arms.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Department of Medicine, Perlmutter Breast Cancer Center, New York University Langone Medical Center, New York, USA. Electronic address: Sylvia.Adams@nyulangone.org.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris and Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Department of Oncology, Centro de Pesquisa Clinica HSL, PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ""Division of Women's Cancers, Dana-Farber Cancer Institute, Boston, USA.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Division of Gynecologic Oncology, University Hospital and German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Henschel', 'Affiliation': 'F. Hoffmann-La Roche, Ltd, Basel, Switzerland.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine (Hematology/Oncology), University of California San Francisco Comprehensive Cancer Center, San Francisco, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Emens', 'Affiliation': 'Division of Hematology/Oncology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Department of Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.02.003'] 164,32179149,Greater optimisation of pharmacokinetic/pharmacodynamic parameters through a loading dose of intravenous colistin in paediatric patients.,"Use of colistin in children is rising in line with the increase of multidrug-resistant Gram-negative bacteria (MDR-GNB). In adults, a colistin loading dose is recommended to achieve therapeutic concentrations within 12-24 h. Here we aimed to describe the pharmacokinetic (PK) parameters of a loading dose versus a recommended initial dose of intravenous colistimethate sodium (CMS) in paediatric patients. A prospective, open-label, PK study was conducted in paediatric patients (age 2-18 years) with normal renal function. Patients (n = 20) were randomly assigned to receive either a CMS loading dose (LD group) of 4 mg of colistin base activity (CBA)/kg/dose or a standard initial dose (NLD group) of 2.5 mg (12-h interval) or 1.7 mg (8-h interval) of CBA/kg/dose. Serial blood samples were collected. Plasma concentrations of formed colistin were measured by LC-MS/MS. PK parameters were reported. Acute kidney injury (AKI) was monitored by serum creatinine and urine NGAL. The median (interquartile range) age and body weight were 8.5 (3.5-11.3) years and 21.5 (13.5-20.0) kg. The mean (standard deviation) of first-dose PK parameters of the LD group versus the NLD group were: C max , 6.1 (2.4) vs. 4.1 (1.3) mg/L; AUC 0- t , 26.5 (12.5) vs. 13.5 (3.6) mg/L·h; V d , 0.7 (0.4) vs. 0.6 (0.3) L/kg; and t 1/2 , 2.9 (0.6) vs. 2.6 (0.4) h. No patient developed AKI by serum creatinine criteria. A CMS loading dose is beneficial for improvement of colistin exposure without increased AKI. A higher daily dose of CMS should be considered, especially for MDR-GNB treatment.",2020,"The mean (standard deviation) of first-dose PK parameters of the LD group vs the NLD group were C max 6.1 (2.4) vs 4.1 (1.3) mg/L, AUC 0-t 26.5 (12.5) vs 13.5 (3.6) mg/L*h, Vd 0.7 (0.4) vs 0.6 (0.3) L/kg, and t 1/2 2.9 (0.6) vs 2.6 (0.4) h.","['Pediatric Patients', 'pediatric patients aged 2 - 18 years with normal renal function', 'Twenty children were enrolled', 'pediatric patients']","['open-label', 'CMS', 'CMS loading dose (LD group) of 4 mg of colistin base activity (CBA)/kg/dose or standard initial dose (NLD', 'intravenous colistimethate sodium (CMS']","['Acute kidney injury (AKI', 'Plasma concentration of formed colistin', 'median (interquartile range) age and body weight']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0110462', 'cui_str': 'Colistimethate sodium'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",20.0,0.0285904,"The mean (standard deviation) of first-dose PK parameters of the LD group vs the NLD group were C max 6.1 (2.4) vs 4.1 (1.3) mg/L, AUC 0-t 26.5 (12.5) vs 13.5 (3.6) mg/L*h, Vd 0.7 (0.4) vs 0.6 (0.3) L/kg, and t 1/2 2.9 (0.6) vs 2.6 (0.4) h.","[{'ForeName': 'Noppadol', 'Initials': 'N', 'LastName': 'Wacharachaisurapol', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Noppadol.W@chula.ac.th.'}, {'ForeName': 'Chayapa', 'Initials': 'C', 'LastName': 'Phasomsap', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Warumphon', 'Initials': 'W', 'LastName': 'Sukkummee', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Weeraya', 'Initials': 'W', 'LastName': 'Phaisal', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ankanee', 'Initials': 'A', 'LastName': 'Chanakul', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Supeecha', 'Initials': 'S', 'LastName': 'Wittayalertpanya', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Chariyavilaskul', 'Affiliation': 'Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.105940'] 165,30702365,Peer Navigator Intervention for Latinos on Hemodialysis: A Single-Arm Clinical Trial.,"Background: Latinos with end-stage renal disease (ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients. Latino ESRD patients uniquely report that social factors (e.g., lack of care coordination, food insecurity, and low health literacy) and mental health influence their HRQOL. We developed a culturally tailored peer navigator (PN) intervention to improve the HRQOL of Latinos on hemodialysis. Objective: To determine the feasibility of the PN intervention. Design: Single-arm prospective study. The PN provided individualized support with advance care planning, care coordination, and counseling about the importance of diet and mental health. Setting and Participants: Latino with ESRD receiving scheduled outpatient thrice-weekly hemodialysis or reliant on emergency-only hemodialysis in Denver. Main measures: Recruitment, retention rates, data completeness, intervention dose, patient- and staff-reported satisfaction with the intervention. Results: Of 49 eligible patients, 40 (82%) agreed to participate. The majority of participants received scheduled outpatient hemodialysis (75%), 20 were women (50%), with a mean (standard deviation [SD]) age of 56 (13) years. No participants withdrew from the intervention. One participant died. The mean (SD) number of PN visits per participant was 7 (2) and the mean (SD) length of the visits was 97 minutes (49). The majority of visits took place at the hemodialysis facility (59%) and home (27%). The vast majority of participants reported that the PN improved their quality of life as a patient on hemodialysis (95%). Conclusions: The PN intervention achieved feasibility goals and was well received by participants.",2019,(ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients.,"['Latino with ESRD receiving scheduled outpatient thrice-weekly hemodialysis or reliant on emergency-only hemodialysis in Denver', 'Latinos on Hemodialysis', 'Latino ESRD patients', 'participants received scheduled outpatient hemodialysis (75%), 20 were women (50%), with a mean (standard deviation [SD]) age of 56 (13) years', ': Latinos with end-stage renal disease', '49 eligible patients, 40 (82%) agreed to participate']","['culturally tailored peer navigator (PN) intervention', 'Peer Navigator Intervention']","['Main measures: Recruitment, retention rates, data completeness, intervention dose, patient- and staff-reported satisfaction with the intervention', 'feasibility goals', 'quality of life', 'mean (SD) number of PN visits', 'mental and kidney composite health-related quality of life (HRQOL) scores']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0380135,(ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients.,"[{'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Cervantes', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': '2 Department of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Romana', 'Initials': 'R', 'LastName': 'Hasnain-Wynia', 'Affiliation': '3 Office of Research, Denver Health, Denver, Colorado.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Steiner', 'Affiliation': '4 Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Havranek', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Madelyne', 'Initials': 'M', 'LastName': 'Hull', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': '5 Colorado School of Public Health, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': '2 Department of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Xochilt', 'Initials': 'X', 'LastName': 'Alamillo', 'Affiliation': '6 Aurora Mental Health Center, Aurora, Colorado.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Camacho', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': '7 Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}]",Journal of palliative medicine,['10.1089/jpm.2018.0439'] 166,32179059,Oxytocin increases the social salience of the outgroup in potential threat contexts.,"A growing body of literature suggests that OT administration may affect not only prosocial outcomes, but also regulate adversarial responses in the context of intergroup relations. However, recent reports have challenged the view of a fixed role of OT in enhancing ingroup favoritism and outgroup derogation. Studying the potential effects of OT in modulating threat perception in a context characterized by racial miscegenation (Brazil) may thus afford additional clarification on the matter. In a double-blind, placebo-controlled study, White Brazilian participants completed a first-person shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members. OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets). In summary, our results indicate that a single dose of OT may promote accurate behavioral responses to potential threat from members of a racial outgroup, thus offering support to the social salience hypothesis.",2020,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).",['White Brazilian participants completed a firstperson shooter task to assess their responses towards potential threat from racial ingroup (White) or outgroup (Black) members'],"['OT', 'Oxytocin', 'placebo']",['social salience'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3875150', 'cui_str': 'Towards'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.040038,"OT administration enhanced the social salience of the outgroup, by both increasing the rate at which participants refrained from shooting unarmed Black targets to levels similar to White targets, and by further increasing the rate of correct decisions to shoot armed Black targets (versus White armed targets).","[{'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Egito', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nevat', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Simone G', 'Initials': 'SG', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'The Integrated Brain and Behavior Research Center (IBBR) and Department of Psychology, University of Haifa, Haifa, 3498838, Israel.'}, {'ForeName': 'Ana Alexandra C', 'Initials': 'AAC', 'LastName': 'Osório', 'Affiliation': 'Social and Cognitive Neuroscience Laboratory and Developmental Disorders Graduate Program, Center for Biological and Health Sciences, Mackenzie Presbyterian University, São Paulo, Brazil. Electronic address: ana.osorio@mackenzie.br.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104733'] 167,32244170,Endogenous in-session cortisol during exposure therapy predicts symptom improvement: Preliminary results from a scopolamine-augmentation trial.,"The purpose of this study was to explore whether individual differences in glucocorticoid concentrations were associated with symptom improvement following exposure therapy for patients with social anxiety disorder. To do this, 60 participants with social anxiety disorder completed a randomized-controlled trial of exposure therapy, where participants were randomized to receive scopolamine-augmentation or placebo during their 7 exposure sessions. Scopolamine is an antimuscarinic which blocks the effects of acetylcholine and reduces autonomic arousal. During sessions 1, 4, 7, and during the post-treatment extinction assessment, participants provided up to 16 saliva samples (4 in each session). Pre-treatment, post-treatment, and at 1-month follow-up, participants completed the Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms. Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up. The association between elevated endogenous in-session cortisol and attenuated symptom change was not moderated by scopolamine treatment condition. Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy. This is the first study, to our knowledge, to examine whether endogenous in-session cortisol concentrations predict symptom changes following exposure therapy for the treatment of social anxiety disorder. More investigation of non-invasive and reliable biological markers that explain variability in responses to effective treatments are needed.",2020,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"['patients with social anxiety disorder', 'social anxiety disorder', '60 participants with social anxiety disorder', 'Individuals with social anxiety disorder who have elevated neuroendocrine signaling may under-benefit from exposure therapy']","['acetylcholine', 'Scopolamine', 'scopolamine', 'scopolamine-augmentation or placebo', 'exposure therapy']","['Liebowitz Social Anxiety Scale to monitor change in fear and avoidance symptoms', 'symptom improvement', 'autonomic arousal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",60.0,0.01704,Elevated endogenous in-session cortisol during exposure sessions was associated with less symptom improvement from pre- to post-treatment and at 1-month follow-up.,"[{'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Kuhlman', 'Affiliation': 'Department of Psychological Science, University of California Irvine, Irvine, CA, 92697, United States; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Institute for Interdisciplinary Salivary Bioscience, University of California Irvine, Irvine, CA, 92697, United States. Electronic address: krkuhl@uci.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Imbriano', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, 90095, United States; Department of Psychology, University of California Los Angeles, Los Angeles, CA, 90095, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104657'] 168,32247219,Choosing endotracheal tube size in children: Which formula is best?,"OBJECTIVES Various formulae have been suggested to calculate the appropriate sized endotracheal tube in children. The current study prospectively compares three commonly used formulae for selection of cuffed endotracheal tubes in children. METHODS Patients were randomized to one of three formulae (Duracher, Cole, or Khine) to determine the size of the cuffed endotracheal tube for endotracheal intubation. The fit of the tube was noted and intracuff pressure was measured using a manometer. The postoperative incidence of stridor, throat pain/soreness, and hoarseness was noted in the post-anesthesia care unit at 2, 4 and 24 h after the procedure. RESULTS The study cohort included 135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender. There was no difference in the intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure was greater than or equal to 20 or 30 cm H 2 O among the three groups. Six tube changes were required in the Cole group while no tube changes were required in the Duracher group (p < 0.05). The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group. CONCLUSION When using an endotracheal tube with a polyurethane cuff, the Duracher formula provided the best estimate for choosing the correct size.",2020,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group. ","['Patients', 'children', '135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender']","['cuffed endotracheal tubes', 'cuffed endotracheal tube for endotracheal intubation', 'three formulae (Duracher, Cole, or Khine']","['postoperative incidence of stridor, throat pain/soreness, and hoarseness', 'intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure', 'intracuff pressure', 'postoperative incidence of adverse events (throat pain, hoarseness, and stridor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3809781', 'cui_str': 'Cole disease'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",135.0,0.0226457,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group. ","[{'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Manimalethu', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Krishna', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: shabana.shafy@nationwidechildrens.org.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA; Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110016'] 169,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans. METHODS This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9 viral particles, the intermediate-dose group received 2·5 × 10 10 viral particles, and the high-dose group received 5 × 10 10 viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578. FINDINGS Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10 viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. INTERPRETATION ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials. FUNDING UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9 viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10 viral particles, and the high-dose group received 5\u2008×\u200810 10 viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshal', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2'] 170,31912800,"Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE).","BACKGROUND Preclinical data suggest that dual blockade of the insulin-like growth factor-1 receptor (IGF-1R) and HER3 pathways has superior activity to IGF-1R blockade alone in pancreatic ductal adenocarcinoma (PDAC). We tested whether istiratumab, an IGF-1R- and ErbB3-bispecific antibody, can enhance the efficacy of standard of care (SOC) chemotherapy in patients with metastatic PDAC selected for high IGF-1 serum levels. PATIENTS AND METHODS CARRIE was an international, randomized, double-blind, placebo-controlled phase II study for patients with previously untreated metastatic PDAC. In part 1, 10 patients were evaluated for pharmacokinetics and safety. In part 2, patients with high free serum IGF-1 levels were randomized 1 : 1 to receive either istiratumab [2.8 g intravenously (i.v.) every 2 weeks] or placebo combined with gemcitabine/nab-paclitaxel at approved dose schedule. The co-primary endpoints were progression-free survival (PFS) in patients with high IGF-1 levels and PFS in patients with both high serum IGF-1 levels and heregulin (HRG)+ tumors. Key secondary endpoints were overall survival (OS), objective response rate (ORR) by RECIST v.1.1, and adverse events (AEs) rate. RESULTS A total of 317 patients were screened, with 88 patients randomized in part 2 (experimental arm n = 43; control n = 45). In the high IGF-1 cohort, median PFS was 3.6 and 7.3 months in the experimental versus control arms, respectively [hazard ratio (HR) = 1.88, P = 0.027]. In the high IGF-1/HRG+ subgroup (n = 44), median PFS was 4.1 and 7.3 months, respectively (HR = 1.39, P = 0.42). Median OS and ORR for the overall population were similar between two arms. No significant difference in serious or grade ≥3 AEs was observed, although low-grade AEs leading to early discontinuation were higher in the experimental (39.5%) versus control arm (24.4%). CONCLUSIONS Istiratumab failed to improve the efficacy of SOC chemotherapy in this patient setting. High serum IGF-1 levels did not appear to be an adverse prognostic factor when compared with non-biomarker-selected historic controls. CLINICAL TRIAL REGISTRATION NUMBERS ClinicalTrials.gov: NCT02399137; EUDRA CT: 2014-004572-34.",2020,"High serum IGF-1 levels did not appear to be an adverse prognostic factor when compared with non-biomarker-selected historic controls. ","['patients with previously untreated metastatic PDAC', 'pancreatic ductal adenocarcinoma (PDAC', '317 patients were screened, with 88 patients randomized in part 2 (experimental arm n\xa0= 43; control n\xa0= 45', 'patients with metastatic PDAC selected for high IGF-1 serum levels', 'patients with high free serum IGF-1 levels', 'front-line metastatic pancreatic cancer (CARRIE']","['istiratumab [2.8\xa0g intravenously (i.v', 'placebo combined with gemcitabine/nab-paclitaxel', 'placebo', 'SOC chemotherapy', 'standard of care (SOC) chemotherapy', 'istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine']","['overall survival (OS), objective response rate (ORR) by RECIST v.1.1, and adverse events (AEs) rate', 'serious or grade ≥3 AEs', 'High serum IGF-1 levels', 'progression-free survival (PFS', 'low-grade AEs leading to early discontinuation', 'median PFS', 'pharmacokinetics and safety', 'Median OS and ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3641662', 'cui_str': 'MM-141'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",317.0,0.515614,"High serum IGF-1 levels did not appear to be an adverse prognostic factor when compared with non-biomarker-selected historic controls. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundranda', 'Affiliation': 'Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Gracian', 'Affiliation': 'Medical Oncology, Centro Integral Oncologico Clara Campal, Madrid, Spain; Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, Madrid, Spain.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Zafar', 'Affiliation': 'Hematology and Oncology, Florida Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meiri', 'Affiliation': 'Medical Oncology, Comprehensive Care and Research Center, Atlanta, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'TUM School of Medicine, Klinikum rechts der Isar, Medizinische Klinik II, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Ahn', 'Affiliation': 'Medical Oncology, Cancer Treatment Centers of America Chicago, Zion, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Charu', 'Affiliation': 'Hematology/Oncology, Pacific Cancer Medical Center, Anaheim, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zalutskaya', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kuesters', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Pipas', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santillana', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Askoxylakis', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Hematology/Oncology, University of California San Francisco Cancer Center, San Francisco, USA. Electronic address: andrew.ko@ucsf.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.09.004'] 171,31377868,"The effects of Tiszasüly and Kolop mud pack therapy on knee osteoarthritis: a double-blind, randomised, non-inferiority controlled study.","The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly and Kolop mud pack therapy on pain, function and quality of life in patients with knee osteoarthritis. In this double-blind, randomised, follow-up study, 60 patients with knee osteoarthritis were treated with either Tiszasüly hot mud pack (group 1) or with Kolop hot mud pack (group 2) on 10 occasions for 2 weeks (10 working days). One hundred millimetre visual analogue scale (VAS) for knee pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Lequesne Index for physical function and EuroQoL-5D for quality-of-life measurements were recorded at baseline, at the end of treatment (week 2) and 3 months later (week 12). In both groups, all measured parameters improved significantly from the baseline until the end of treatment and during the follow-up period (p < 0.05). There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits. Knee pain improved in both groups at week 2 and week 12; the only significant difference visible between the groups was at the end of the treatment in favour of the Tiszasüly mud pack group (p = 0.009). Tiszasüly and Kolop mud packs both have a favourable effect on knee pain, physical function and quality of life in patients with knee osteoarthritis. Our results proved non-inferiority of Tiszasüly mud pack.",2020,"There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits.","['patients with knee osteoarthritis', '60 patients with knee osteoarthritis', 'knee osteoarthritis']","['Tiszasüly and Kolop mud pack therapy', 'Tiszasüly hot mud pack (group 1) or with Kolop hot mud pack']","['WOMAC, KOOS, EQ-5D and Lequesne Index', 'pain, function and quality of life', 'millimetre visual analogue scale (VAS) for knee pain, the Western Ontario and McMaster Universities Arthritis Index', 'knee pain, physical function and quality of life', 'Lequesne Index for physical function and EuroQoL-5D for quality-of-life measurements', 'Knee pain', 'WOMAC), the Knee injury and Osteoarthritis Outcome Score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0949364', 'cui_str': 'Mud Packs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0480853,"There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits.","[{'ForeName': 'Márta', 'Initials': 'M', 'LastName': 'Király', 'Affiliation': 'Petz Aladár County Teaching Hospital, Híd u.2., Győr, H-9025, Hungary.'}, {'ForeName': 'Eszter', 'Initials': 'E', 'LastName': 'Kővári', 'Affiliation': 'School of PhD Studies, Semmelweis University, Üllői út 26., Budapest, H-1085, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Hodosi', 'Affiliation': 'Medical and Health Science Center, University of Debrecen, Nagyerdei körút 98., Debrecen, H-4012, Hungary.'}, {'ForeName': 'Péter V', 'Initials': 'PV', 'LastName': 'Bálint', 'Affiliation': '3rd Rheumatology Department, National Institute of Rheumatology and Physiotherapy, Frankel L. u. 25-29., Budapest, H-1023, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Bender', 'Affiliation': 'Polyclinic of Hospitaller Brothers of St. John of God, Árpád fejedelem útja 7., Budapest, H-1023, Hungary. bender.tamas@irgalmas.hu.'}]",International journal of biometeorology,['10.1007/s00484-019-01764-4'] 172,32084530,Effects of antiemetic doses of dexamethasone on plasma mediators of inflammation resolution and pain after surgery in women.,"BACKGROUND Dexamethasone is commonly given as an antiemetic during surgical procedures. It has immunosuppressive effects and can affect key enzymes involved in the synthesis of specialised lipid mediators of inflammation resolution (SPM) that direct inflammation resolution and have anti-nociceptive actions. This study examined the effect of dexamethasone on plasma SPM, and the relationship between SPM and perceived pain in women undergoing surgery. METHODS Plasma SPM were measured in samples obtained from two double-blind controlled interventions. The first, included 51 women mean age 53 ± 1.5 years, undergoing breast surgery allocated to either intravenous saline, or dexamethasone (4 mg or 8 mg) after induction of anaesthesia. The second study included 31 women of mean age 44 ± 0.5 years undergoing laparoscopic gynecological surgery that were allocated to either saline, or dexamethasone (4 mg). SPM (18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2) were measured in plasma collected prior to induction of anaesthesia and at 24 h, and 6 weeks post-surgery. Pain was assessed using a verbal analogue scale at discharge from the post-anaesthesia recovery unit. The data from each study was combined to examine the effect of dexamethasone on plasma SPM. The relationship between pain score and SPM was examined using ordinal logistic regression. RESULTS The SPM 18-HEPE, 17-HDHA, RvE2, RvD1 17R-RvD1 and RvD2 were detectable in all plasma samples. There was no significant difference in any SPM due to dexamethasone over the duration of the study. There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2. Pain score was negatively related to levels of RvE2 measured prior to induction of anaesthesia (rho = -0.2991, P = 0.006) and positively related to BMI (rho = 0.279, P = 0.011). In ordinal logistic regression the odds ratio for RvE2 was 0.931 (CI 0.880, 0.986; P = 0.014); after adjusting for the effect of BMI indicating that an increase in RvE2 of 1 pg/ml would result in a 6.9 % fall in pain score. Allocation to a dexamethasone group did not influence the pain score or the relationship between RvE2 and pain score. CONCLUSION Dexamethasone administered as an anti-emetic does not affect plasma SPM levels. An elevated RvE2 level prior to surgery is predictive of a lower perceived pain score post-anaesthesia.",2020,"There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2.","['31 women of mean age 44 ± 0.5 years undergoing laparoscopic gynecological surgery', '51 women mean age 53 ± 1.5 years, undergoing breast surgery allocated to either', 'women undergoing surgery', 'after surgery in women']","['Dexamethasone', 'saline, or dexamethasone', 'intravenous saline, or dexamethasone', 'SPM ', 'dexamethasone']","['levels of RvE2 measured prior to induction of anaesthesia', 'Pain score', 'RvE2', '18-HEPE, 17-HDHA', 'SPM', 'plasma mediators of inflammation resolution and pain', 'pain score', 'downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2', 'plasma SPM levels', 'fall in 17-HDHA', 'Pain', 'elevated RvE2 level', 'pain score and SPM', 'RvE2 and pain score', 'plasma SPM', 'RvD1 17R-RvD1 and RvD2', 'RvE2, RvD1 17R-RvD1 and RvD2']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C4310301', 'cui_str': '17(S)-HDHA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0243042', 'cui_str': 'Inflammation Mediators'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",51.0,0.225454,"There was a fall in 17-HDHA between baseline and 24 h in both the dexamethasone and saline groups (P = 0.003) but no change in the downstream SPM (RvD1, 17R-RvD1 and RvD2) or 18-HEPE and RvE2.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Barden', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia. Electronic address: anne.barden@uwa.edu.au.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Harry Perkins Institute for Medical Research, University of Western Australia, Australia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Mas', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Hill', 'Affiliation': 'Department of Anaesthesia, St John of God Midland and Mount Lawley Hospitals, Perth, Western Australia, Western Australia, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Mowat', 'Affiliation': 'Department of Anaesthesia, Royal Bournemouth & Christchurch Hospitals NHS Foundation Trusts, United Kingdom.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Loh', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Corcoran', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia; Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Mori', 'Affiliation': 'Medical School, Royal Perth Hospital Unit, University of Western Australia, Australia.'}]",Prostaglandins & other lipid mediators,['10.1016/j.prostaglandins.2020.106427'] 173,31959339,"Cisplatin and 5-fluorouracil with or without epidermal growth factor receptor inhibition panitumumab for patients with non-resectable, advanced or metastatic oesophageal squamous cell cancer: a prospective, open-label, randomised phase III AIO/EORTC trial (POWER).","BACKGROUND Palliative chemotherapy of advanced oesophageal squamous cell cancer (ESCC) consists of cisplatin/5-fluorouracil (CF) to target epidermal growth factor receptor (EGFR) with panitumumab (P); chemotherapy enhanced overall survival (OS) in advanced colorectal or squamous cell head and neck cancers. With prospective serum and tumour biomarkers, we tested if P added to CF (CFP) improved OS in advanced ESCC. PATIENTS AND METHODS Eligible patients with confirmed ESCC that was not curatively resectable or did not qualify for definitive radiochemotherapy, were randomised 1 : 1 to receive CF [cisplatin (C) 100 mg/m 2 i.v., day 1; 5-fluorouracil (F) 1000 mg/m 2 i.v., days 1-4] or CF plus P (9 mg/kg, i.v., day 1, each q3-week cycle) until progressive disease or unacceptable toxicity. Safety was reviewed by the Data Safety Monitoring Board after 40, 70 and 100 patients who completed at least one cycle. After 53 enrolled patients, cisplatin was reduced from 100 mg/m 2 to 80 mg/m 2 . RESULTS The trial was stopped early based on interim efficacy results triggered by the third safety analysis: median OS (mOS) favoured CF over CFP, regardless of cisplatin dose [hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.06-2.98; P = 0.028]. In the final analysis, mOS was 10.2 versus 9.4 months for CF versus CFP, respectively (HR 1.17, 95% CI 0.79-1.75; P = 0.43). One hundred (70.4%) of 142 patients in the safety population died, 51 (51.0%) with CFP. Most deaths were related to disease progression [44/49 (90%) deaths in CF versus 34/51 (67%) deaths in CFP]; objective responses [27/73 (37.0%)] were identical. The most common serious adverse events were kidney injury [3 (4.3%) versus 7 (9.7%)], general health deterioration [5 (7.1%) versus 5 (6.9%)] and dysphagia [4 (5.7%) versus 4 (5.6%)] in CF versus CFP, respectively. There were three (4.3%) and 17 (23.6%) common terminology criteria for adverse events (CTCAE) grade 5 events in CF versus CFP, respectively. Low soluble (s)EGFR levels were associated with better progression-free survival; sEGFR was induced under CFP. CONCLUSION EGFR inhibition added to CF did not improve survival in unselected advanced ESCC patients. The results support further liquid biopsy studies. TRIAL REGISTRATION ClinicalTrials.gov (NCT01627379) and EudraCT (2010-020606-15).",2020,"Low soluble (s)EGFR levels were associated with better progression-free survival; sEGFR was induced under CFP. ","['patients with non-resectable, advanced or metastatic oesophageal squamous cell cancer', 'Eligible patients with confirmed ESCC that was not curatively resectable or did not qualify for definitive radiochemotherapy', 'advanced colorectal or squamous cell head and neck cancers', 'advanced oesophageal squamous cell cancer (ESCC', 'unselected advanced ESCC patients']","['Cisplatin and 5-fluorouracil with or without epidermal growth factor receptor inhibition panitumumab', 'CF [cisplatin (C) 100 mg/m 2 i.v', 'panitumumab (P); chemotherapy', 'P added to CF (CFP', 'cisplatin/5-fluorouracil (CF', '5-fluorouracil', 'cisplatin', 'EudraCT']","['disease progression', 'general health deterioration', 'survival', 'progression-free survival; sEGFR', 'Low soluble (s)EGFR levels', 'overall survival (OS', 'dysphagia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0563273', 'cui_str': 'General health deterioration (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",53.0,0.320511,"Low soluble (s)EGFR levels were associated with better progression-free survival; sEGFR was induced under CFP. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany. Electronic address: markus.moehler@unimedizin-mainz.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maderer', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Thuss-Patience', 'Affiliation': 'Medical Department, Division of Hematology, Oncology and Tumor Immunology, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': 'Institute of Oncology, Davidoff Center, Rabin Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meiler', 'Affiliation': 'Department of Internal Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Department of Internal Medicine I, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'R-D', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Medical Department III, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research, Hospital North-West, Frankfurt, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mueller', 'Affiliation': 'Oncology Leer-Emden-Papenburg, Leer, Germany.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Lutz', 'Affiliation': 'Gastroenterology, Caritas Hospital, Saarbrücken, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': '1st Medical Department and University Cancer Center Leipzig, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alsina', 'Affiliation': ""Department of Medical Oncology, Hospital Universitari Vall d'Hebron and Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Borchert', 'Affiliation': 'Medical Department III, University Hospital Rostock, Rostock, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': '3rd Medical Department, Cancer Research Institute, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Eisterer', 'Affiliation': 'Department of Internal Medicine V, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schad', 'Affiliation': 'Institute of Pathology, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slotta-Huspenina', 'Affiliation': 'Institute of Pathology, School of Medicine, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Medical Department III, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.018'] 174,32333590,The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial.,"BACKGROUND Amnestic mild cognitive impairment (aMCI) is often the prodromal stage of Alzheimer's disease (AD). Although previous studies have suggested that computerized cognitive training is an effective non-pharmacological intervention for aMCI, large-sample, randomized controlled studies are warranted to provide a high level of evidence. OBJECTIVE To identify the efficacy of computerized cognitive training for aMCI. METHODS This study will include 260 patients diagnosed with aMCI from 8 centers in China. A computerized multi-domain adaptive training program will be used in this study, and the targeted cognitive domains include memory, attention, language, and executive function. The patients will be randomized into either a cognitive-training group or an active-control group. The intervention is a 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week. Neuropsychological assessments and structural and functional MRI will be obtained at baseline, at the end of the intervention, and 6 months after randomization. The primary outcome will be the global cognitive function score assessed by Montreal Cognitive Assessment. The secondary outcomes include changes in other neuropsychological assessments and neuroplasticity changes measured by structural and functional MRI. RESULTS The trial is currently ongoing, and it is anticipated that recruitment will be completed in December 2020. CONCLUSION This multi-center, large-sample, randomized controlled trial will investigate the short and long-term effects of computerized cognitive training in patients with aMCI. Furthermore, the combination of functional and structural MRI results will also reveal the underlying mechanisms of the effect of intervention.",2020,"The intervention is a 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week.","['260 patients diagnosed with aMCI from 8 centers in China', 'Amnestic mild cognitive impairment (aMCI', 'patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT', 'patients with aMCI']","['computerized cognitive training', 'cognitive-training group or an active-control group', 'COGnitive tRaining']","['changes in other neuropsychological assessments and neuroplasticity changes measured by structural and functional MRI', 'global cognitive function score assessed by Montreal Cognitive Assessment', 'Neuropsychological assessments and structural and functional MRI']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034760', 'cui_str': 'Reagents'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",260.0,0.147281,"The intervention is a 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Zude', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Collaborative Innovation Center for Language Ability, Jiangsu Normal University, Xuzhou, China.'}, {'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Junjian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Zhongnan Hospital, Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiumin', 'Initials': 'Q', 'LastName': 'Qu', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology and Neuroscience Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Beijing Friendship Hospital, Beijing, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Brainnetome Center, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yueyi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Beijia', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191314'] 175,32331393,Effects of One Versus Two Doses of a Multi-Ingredient Pre-Workout Supplement on Metabolic Factors and Perceived Exertion during Moderate-Intensity Running in Females.,"The primary purpose of this study was to examine the acute effects of one versus two doses of a multi-ingredient pre-workout supplement on energy expenditure during moderate-intensity treadmill running. In addition, our second aim was to investigate the responses of associated metabolic factors (i.e., substrate utilization, measures of gas exchange), perceived exertion, and resting cardiovascular variables with one and two doses of the pre-workout supplement. Twelve females (mean ± SD: age = 25.3 ± 9.4 years; body mass = 61.2 ± 6.8 kg) completed three bouts of 30 min of treadmill running at 90% of their ventilatory threshold on separate days after consuming one dose of the pre-workout supplement (1-dose), two doses (2-dose), and a placebo. There were no differences among conditions for energy expenditure, fat or carbohydrate oxidation, respiratory exchange ratio, oxygen consumption, or heart rate across exercise time. The two-dose group, however, had lower ( p = 0.036) ratings of perceived exertion (11.8 ± 1.7) than the one-dose (12.6 ± 1.7) and the placebo (12.3 ± 1.2) at the 20-min time point of exercise as well as greater resting systolic blood pressure (110 ± 10 mmHg) compared to the one-dose (106 ± 10 mmHg) and the placebo (104 ± 10 mmHg) conditions. Both the one-dose and two-dose conditions had greater increases in diastolic blood pressure compared to the placebo. Thus, our findings indicated that the present pre-workout supplement had no performance-enhancing benefits related to energy metabolism but did attenuate feelings of exertion.",2020,"The two-dose group, however, had lower ( p = 0.036) ratings of perceived exertion (11.8 ± 1.7) than the one-dose (12.6 ± 1.7) and the placebo (12.3 ± 1.2) at the 20-min time point of exercise as well as greater resting systolic blood pressure (110 ± 10 mmHg) compared to the one-dose (106 ± 10 mmHg) and the placebo (104 ± 10 mmHg) conditions.","['Twelve females (mean ± SD: age = 25.3 ± 9.4 years; body mass ', 'Females']","['Multi-Ingredient Pre-Workout Supplement', 'placebo', 'multi-ingredient pre-workout supplement']","['Metabolic Factors and Perceived Exertion', 'energy expenditure', 'resting systolic blood pressure', 'energy expenditure, fat or carbohydrate oxidation, respiratory exchange ratio, oxygen consumption, or heart rate across exercise time', 'diastolic blood pressure']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.187885,"The two-dose group, however, had lower ( p = 0.036) ratings of perceived exertion (11.8 ± 1.7) than the one-dose (12.6 ± 1.7) and the placebo (12.3 ± 1.2) at the 20-min time point of exercise as well as greater resting systolic blood pressure (110 ± 10 mmHg) compared to the one-dose (106 ± 10 mmHg) and the placebo (104 ± 10 mmHg) conditions.","[{'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Erickson', 'Affiliation': 'Exercise and Sport Science, University of Wisconsin-La Crosse, La Crosse, WI 54601, USA.'}, {'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Camic', 'Affiliation': 'Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sports Medicine, Mayo Clinic Health System, Onalaska, WI 54650, USA.'}, {'ForeName': 'Paige M', 'Initials': 'PM', 'LastName': 'Pellersels', 'Affiliation': 'Physical Therapy, Nova Southeastern University, Fort Lauderdale, FL 33328, USA.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Wright', 'Affiliation': 'Exercise and Sport Science, University of Wisconsin-La Crosse, La Crosse, WI 54601, USA.'}, {'ForeName': 'Shaine E', 'Initials': 'SE', 'LastName': 'Henert', 'Affiliation': 'Kinesiology and Physical Education, Northern Illinois University, DeKalb, IL 60115, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Foster', 'Affiliation': 'Exercise and Sport Science, University of Wisconsin-La Crosse, La Crosse, WI 54601, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040052'] 176,31959342,A randomised phase II trial of three dosing regimens of radium-223 in patients with bone metastatic castration-resistant prostate cancer.,"BACKGROUND Radium-223 prolongs overall survival and delays symptomatic skeletal events (SSEs) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. The approved radium-223 regimen is 55 kBq/kg every 4 weeks (q4w) for six cycles (standard dose). We investigated different radium-223 regimens in patients with mCRPC. PATIENTS AND METHODS Patients were randomised 1 : 1 : 1 to radium-223 standard-dose, high-dose (88 kBq/kg q4w for six cycles) or extended-schedule arms (55 kBq/kg q4w for 12 cycles). The primary end point, SSE-free survival (SSE-FS), was compared in patients treated with a high- versus standard-dose regimen, or with a standard dose in an extended (>6 to 12 cycles) versus standard schedule (six cycles). RESULTS A total of 391 patients were randomised; baseline characteristics were balanced between arms. On-treatment SSEs developed in 37/130 (28%), 42/130 (32%) and 48/131 (37%) patients in the standard-dose, high-dose and extended-schedule arms, respectively. There was no statistically significant difference in SSE-FS in the high- versus standard-dose arms [median 12.9 months versus 12.3 months; hazard ratio (HR) 1.06, 80% confidence interval (CI) 0.88-1.27, P = 0.70], and in the extended- versus standard-schedule arms (median 10.8 months versus 13.2 months; HR 1.26, 80% CI 0.94-1.69, P = 0.31). Overall survival in the three treatment arms was similar. As many as 370 (95%) patients received treatment (median of six cycles) in each arm. Grade ≥3 treatment-emergent adverse events (TEAEs) affected 34% of patients in the standard-dose, 48% in the high-dose and 53% in the extended-schedule arm, causing permanent discontinuation in 9%, 16% and 17% of patients, respectively. CONCLUSION Radium-223 high-dose or extended-schedule regimens resulted in no change in SSE-FS or other efficacy end points and were associated with more grade ≥3 TEAEs. The extended-schedule regimen (beyond six doses) could not be implemented in a large proportion of patients due to disease progression. Therefore, the standard-dose schedule remains one of the standard therapies for patients with symptomatic mCRPC. TRIAL REGISTRATION ClinicalTrials.govNCT02023697.",2020,"CONCLUSION Radium-223 high-dose or extended-schedule regimens resulted in no change in SSE-FS or other efficacy end points and were associated with more grade ≥3 TEAEs.","['Patients were randomised 1 : 1 : 1 to', 'patients with bone metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases', 'A total of 391 patients', 'patients with mCRPC', 'patients with symptomatic mCRPC']","['radium-223 standard-dose, high-dose (88 kBq/kg q4w for six cycles) or extended-schedule arms', 'radium-223']","['SSE-free survival (SSE-FS', 'Grade ≥3 treatment-emergent adverse events (TEAEs', 'permanent discontinuation', 'SSE-FS', 'Overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0560040', 'cui_str': 'kBq'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",391.0,0.268008,"CONCLUSION Radium-223 high-dose or extended-schedule regimens resulted in no change in SSE-FS or other efficacy end points and were associated with more grade ≥3 TEAEs.","[{'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medical Center, New York, USA. Electronic address: cns9006@med.cornell.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Montreal Cancer Institute, Montreal University Hospital Center (CHUM), Montreal, QC, Canada.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Graff', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University and VA Portland Health Care System, Portland, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Department of Oncology, Rambam Health Care Center, Haifa, Israel.'}, {'ForeName': 'U N', 'Initials': 'UN', 'LastName': 'Vaishampayan', 'Affiliation': 'Department of Oncology, Wayne State University/Karmanos Cancer Institute, Detroit, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Leung', 'Affiliation': 'Division of Nuclear Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Institute of Oncology, Rabin Medical Center-Davidoff Cancer Center, Petah Tikva, Israel.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Epstein', 'Affiliation': ""Department of Medical Oncology, The Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Australia; Eastern Health, Melbourne, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Clinical Statistics Oncology, Bayer HealthCare Pharmaceutical Inc, Whippany, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trandafir', 'Affiliation': 'Global Clinical Development, Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Wagner', 'Affiliation': 'Global Clinical Development, Bayer Consumer Care AG, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Hematology/Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.025'] 177,32330315,Photobiomodulation Therapy is Able to Modulate PGE 2 Levels in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial.,"BACKGROUND AND OBJECTIVES Non-specific low back pain (LBP) is responsible for triggering increased biomarkers levels. In this way, photobiomodulation therapy (PBMT) may be an interesting alternative to treat these patients. One of the possible biological mechanisms of PBMT involved to decrease pain intensity in patients with musculoskeletal disorders is modulation of the inflammatory mediators' levels. The aim of this study was to evaluate the effects of PBMT compared with placebo on inflammatory mediators' levels and pain intensity in patients with chronic non-specific LBP. STUDY DESIGN/MATERIALS AND METHODS A prospectively registered, randomized triple-blinded (volunteers, therapists, and assessors), placebo-controlled trial was performed. Eighteen patients with chronic non-specific LBP were recruited and treated with a single session of active PBMT or placebo PBMT. The primary outcome of the study was serum prostaglandin E 2 levels and the secondary outcomes were tumor necrosis factor-α, interleukin-6 levels, and pain intensity. All outcomes were measured before and after 15 minutes of treatment session. RESULTS PBMT was able to decrease prostaglandin E 2 levels at post-treatment compared with placebo, with a mean difference of -1470 pg/ml, 95% confidence interval -2906 to -33.67 in patients with LBP. There was no difference between groups in the other measured outcomes. Patients did not report any adverse events. CONCLUSION Our results suggest that PBMT was able to modulate prostaglandin E 2 levels, indicating that this may be one of the mechanisms involved in the analgesic effects of PBMT in patients with LBP. Trial registration number (ClinicalTrials.gov): NCT03859505. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.",2020,"RESULTS PBMT was able to decrease prostaglandin E 2 levels at post-treatment compared with placebo, with a mean difference of -1470 pg/ml, 95% confidence interval -2906 to -33.67 in patients with LBP.","['patients with musculoskeletal disorders', '2020', 'patients with chronic non-specific LBP', 'Patients With Chronic Non-Specific Low Back Pain', 'patients with LBP', 'Eighteen patients with chronic non-specific LBP']","['active PBMT or placebo PBMT', 'photobiomodulation therapy (PBMT', 'Placebo', 'PBMT', 'placebo']","['pain intensity', ""inflammatory mediators' levels and pain intensity"", 'serum prostaglandin E 2 levels and the secondary outcomes were tumor necrosis factor-α, interleukin-6 levels, and pain intensity', 'prostaglandin E 2 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",18.0,0.600828,"RESULTS PBMT was able to decrease prostaglandin E 2 levels at post-treatment compared with placebo, with a mean difference of -1470 pg/ml, 95% confidence interval -2906 to -33.67 in patients with LBP.","[{'ForeName': 'Shaiane S', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Cesário Galeno, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Leonardo O P', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Cesário Galeno, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Joensen', 'Affiliation': 'Department of Global Public Health and Primary Care, Physiotherapy Research Group, Kalfarveien, Bergen, 5018, Norway.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Stausholm', 'Affiliation': 'Department of Global Public Health and Primary Care, Physiotherapy Research Group, Kalfarveien, Bergen, 5018, Norway.'}, {'ForeName': 'Ingvill F', 'Initials': 'IF', 'LastName': 'Naterstad', 'Affiliation': 'Department of Global Public Health and Primary Care, Physiotherapy Research Group, Kalfarveien, Bergen, 5018, Norway.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': 'Department of Dental Medicine, Karolinska Institutet and Scandinavian Center of Orofacial Neurosciences (SCON), SE 14104, Huddinge, Sweden.'}, {'ForeName': 'Ernesto Cesar P', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': 'Department of Global Public Health and Primary Care, Physiotherapy Research Group, Kalfarveien, Bergen, 5018, Norway.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': 'Department of Global Public Health and Primary Care, Physiotherapy Research Group, Kalfarveien, Bergen, 5018, Norway.'}]",Lasers in surgery and medicine,['10.1002/lsm.23255'] 178,31809359,Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me).,"BACKGROUND HIV testing is critical to HIV prevention and care. Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen. Novel interventions to increase HIV testing rates among young Black men who have sex with men and transwomen are needed. METHODS A randomized controlled trial among 236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach. Participants completed a computerized baseline assessment and were randomized to electronically receive either a personalized recommendation or standard HIV testing information. Follow-up surveys were conducted online at 3 and 6 months. RESULTS Retention was 92% and 93% at 3-month and 6-month follow-up, respectively. At baseline, 41% of participants reported that they tested for HIV in the past 3 months and another 25% between 4 and 6 months ago. Intent-to-treat analyses found that participants randomized to the experimental arm (personalized recommendation) were not significantly more likely to test for HIV compared with participants in the standard HIV testing information control arm at 3 months (76% vs. 71%; P = 0.40) and 6 months (73% vs. 72%; P = 0.81), respectively. CONCLUSIONS This study evaluated an innovative intervention to increase HIV testing by matching individuals to optimal HIV testing approaches. Participants in both arms increased past 3-month HIV testing, suggesting that providing information on options and/or raising risk awareness is sufficient to significantly increase HIV testing. TRIAL REGISTRATION ClinicalTrial.gov NCT02834572 https://clinicaltrials.gov/ct2/show/NCT02834572.",2020,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"['young Black men who have sex with men and transwomen', 'Young Black Men and Transwomen', 'young Black men who have sex with men and transwomen are needed', '236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach', 'Who Have Sex With Men or Transwomen to HIV Testing Options in New York City ']","['personalized recommendation or standard HIV testing information', 'Novel interventions']",['HIV testing rates'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",236.0,0.115138,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Frye', 'Affiliation': 'Department of Community Health and Social Medicine,Department of Community Health and Social Medicine, Sophie Davis Biomedical Education Program, City University of New York School of Medicine, City University of New York, New York, NY.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Nandi', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Chiasson', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Wilton', 'Affiliation': 'Department of Human Development, Binghamton University, Binghamton, NY.'}, {'ForeName': 'DaShawn', 'Initials': 'D', 'LastName': 'Usher', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Biostatistics and Institute for Health, Health Care Policy and Aging Research, Rutgers, The State University of New Jersey, Piscataway, NJ.'}, {'ForeName': 'Beryl A', 'Initials': 'BA', 'LastName': 'Koblin', 'Affiliation': 'Independent Consultant, Metuchen, NJ.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002223'] 179,32229520,Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs.,"INTRODUCTION Although shortcomings in clinician-family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution. METHODS AND ANALYSIS This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4-6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians' workflow. The primary outcome is surrogates' ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants. ETHICS AND DISSEMINATION We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT02445937.",2020,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","['Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians', '690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania']",[],"[""surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation"", ""surrogates' ratings of the quality of communication during the ICU stay""]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0222045'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.0661771,"Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.","[{'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Lincoln', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Shields', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Praewpannarai', 'Initials': 'P', 'LastName': 'Buddadhumaruk', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Chung-Chou H', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Pike', 'Affiliation': 'Department of Neuroscience, Ely Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Hsiangyu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Kozar', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pidro', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Kahn', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Darby', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Donald Wolff Center for Quality Improvement and Innovation, UPMC Health System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Department of General Internal Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, The CRISMA Center, Program on Ethics and Decision Making, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA douglas.white@pitt.edu.'}]",BMJ open,['10.1136/bmjopen-2019-033521'] 180,30420725,Reduction of personal PM 2.5 exposure via indoor air filtration systems in Detroit: an intervention study.,"The adverse health effects of fine particulate matter (PM < 2.5 μm in diameter [PM 2.5 ]) air pollution are well-documented. There is a growing body of evidence that high-efficiency particulate arrestance (HEPA) filtration can reduce indoor PM 2.5 concentrations and deliver some health benefits via the reduction of exposure to PM. However, few studies have tested the ability of portable air filtration systems to lower overall personal-level PM 2.5 exposures. The Reducing Air Pollution in Detroit Intervention Study (RAPIDS) was designed to evaluate cardiovascular health benefits and personal PM 2.5 exposure reductions via indoor portable air filtration systems among senior citizens in Detroit, Michigan. We evaluated the utility of two commercially available high-efficiency (HE: true-HEPA) and low-efficiency (LE: HEPA-type) indoor air filtration to reduce indoor PM 2.5 concentrations and personal PM 2.5 exposures for 40 participants in a double-blinded randomized crossover intervention. Each participant was subjected to three intervention scenarios: HE, LE, or no filter (control) of three consecutive days each, during which personal, indoor, and outdoor PM 2.5 concentrations were measured daily. For mean indoor PM 2.5 concentrations, we observed 60 and 52% reductions using HE and LE filters, respectively, relative to no filtration. Personal PM 2.5 exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario. To our knowledge, this is the first indoor air filtration intervention study to examine the effectiveness of both HE and LE filters in reducing personal PM 2.5 exposures.",2019,"Personal PM 2.5 exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario.","['40 participants', 'Detroit']",['personal PM 2.5 exposure via indoor air filtration systems'],[],[],"[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0312513,"Personal PM 2.5 exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Maestas', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rosemary A', 'Initials': 'RA', 'LastName': 'Ziemba', 'Affiliation': 'Community Health Nursing, Ann Arbor, MI, USA.'}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Crane', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Klaver', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Spino', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sara D', 'Initials': 'SD', 'LastName': 'Adar', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA. tomoko@msu.edu.'}]",Journal of exposure science & environmental epidemiology,['10.1038/s41370-018-0085-2'] 181,32304734,Cetirizine inhibits gender-specific blood cell dynamics upon allergen contact in allergic rhinitis.,"IgE-mediated inflammatory responses upon allergen contact in allergic rhinitis (AR) are associated with rapid alterations of circulating blood cell numbers detectable in a complete blood count (CBC). Aim of this study was to evaluate whether intake of antihistamines may modulate allergen-induced CBC dynamics in male and female patients. A total of N = 112 specific allergen challenges were performed in otherwise healthy AR subjects. Seventy-two (n = 72) subjects received placebo and forty (n = 40) received cetirizine (H1-receptor antagonist) per os prior to allergen exposure in a randomized, double-blind trial at the Vienna Challenge Chamber (VCC); a subgroup of twenty-five (n = 25) subjects received cetirizine and placebo on different study days (parallel group). Blood samples and symptom scores were taken at baseline and immediately after 6 h of airway challenge simulating ambient allergen contact. Female sex was associated with a pronounced circulating monocyte increase (p < .01) and male sex with an eosinophil decrease (p < .05) in the placebo group, but not in cetirizine treated subjects. The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes. A more prominent thrombocyte increase in female subjects (p < .05) was noted upon allergen exposure, regardless of prior cetirizine intake. Cetirizine inhibited the mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers, but did not affect thrombocyte increase upon allergen challenge. It further diminished gender-specific blood cell dynamics. Overall, as reflected in a simple CBC, cetirizine critically diminished immediate and late innate immune responses subsequent to allergen exposure.",2020,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"['allergic rhinitis', 'Seventy-two (n\u202f=\u202f72) subjects received', 'allergic rhinitis (AR', 'male and female patients', 'otherwise healthy AR subjects']","['cetirizine (H1-receptor antagonist) per os prior to allergen exposure', 'cetirizine and placebo', 'Cetirizine', 'antihistamines', 'placebo', 'cetirizine']","['circulating erythrocytes', 'segmented neutrophils', 'Blood samples and symptom scores', 'mobilization of neutrophils, lymphocytes and decline in erythrocyte numbers', 'circulating monocyte increase']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0034814', 'cui_str': 'Histamine H1 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0229640', 'cui_str': 'Segmented neutrophil'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0553698', 'cui_str': 'Monocyte count increased'}]",72.0,0.125116,The significant increase in segmented neutrophils (p < .001) and decrease in circulating erythrocytes (p < .01) upon allergen challenge was less prominent after cetirizine intake in both sexes.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria. Electronic address: galateja.jordakieva@meduniwien.ac.at.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Department of Environmental Health, Medical University of Vienna, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Dept. Vienna Challenge Chamber (VCC), Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jensen-Jarolim', 'Affiliation': 'Institute of Pathophysiology and Allergy Research, Center of Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria; The Interuniversity Messerli Research Institute, Medical University Vienna, University of Veterinary Medicine Vienna, University of Vienna, Austria.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2020.108422'] 182,31042696,Effects of MDMA on attention to positive social cues and pleasantness of affective touch.,"The psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA) reportedly produces distinctive feelings of empathy and closeness with others. MDMA increases social behavior in animal models and has shown promise in psychiatric disorders, such as autism spectrum disorder (ASD) and post-traumatic stress disorder (PTSD). How it produces these prosocial effects is not known. This behavioral and psychophysiological study examined the effects of MDMA, compared with the prototypical stimulant methamphetamine (MA), on two measures of social behavior in healthy young adults: (i) responses to socially relevant, ""affective"" touch, and (ii) visual attention to emotional faces. Men and women (N = 36) attended four sessions in which they received MDMA (0.75 or 1.5 mg/kg), MA (20 mg), or a placebo in randomized order under double-blind conditions. Responses to experienced and observed affective touch (i.e., being touched or watching others being touched) were assessed using facial electromyography (EMG), a proxy of affective state. Responses to emotional faces were assessed using electrooculography (EOG) in a measure of attentional bias. Subjective ratings were also included. We hypothesized that MDMA, but not MA, would enhance the ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions. Consistent with this, we found that MDMA, but not MA, selectively enhanced ratings of pleasantness of experienced affective touch. Neither drug altered the ratings of pleasantness of observed touch. On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces. These results provide new evidence that MDMA can enhance the experience of positive social interactions; in this case, pleasantness of physical touch and attentional bias toward positive facial expressions. The findings are consistent with evidence that the prosocial effects are unique to MDMA relative to another stimulant. Understanding the behavioral and neurobiological processes underlying the distinctive social effects of MDMA is a key step to developing the drug for psychiatric disorders.",2019,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","['Men and women (N\u2009=\u200936) attended four sessions in which they received', 'healthy young adults']","['placebo', 'psychostimulant drug ±3,4-methylenedioxymethamphetamine (MDMA', 'MDMA', 'electrooculography (EOG', 'MA', 'prototypical stimulant methamphetamine (MA']","['ratings of pleasantness and psychophysiological responses to affective touch and increase attentional bias toward positive facial expressions', 'positive social cues and pleasantness of affective touch', 'Subjective ratings', 'ratings of pleasantness of observed touch', 'attention toward happy faces']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0013854', 'cui_str': 'EOG'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0389876,"On the EOG measure of attentional bias, MDMA, but not MA, increased attention toward happy faces.","[{'ForeName': 'Anya K', 'Initials': 'AK', 'LastName': 'Bershad', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mayo', 'Affiliation': 'Center for Social and Affective Neuroscience, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kathryne', 'Initials': 'K', 'LastName': 'Van Hedger', 'Affiliation': 'Department of Clinical Neurological Sciences, University of Western Ontario, London, ON, UK.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'McGlone', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. hdew@uchicago.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0402-z'] 183,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I. RESULTS Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. CONCLUSIONS The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. ","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. ","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0'] 184,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. METHODS We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. RESULTS A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. CONCLUSIONS In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282'] 185,32193052,Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial.,"OBJECTIVE Obstructive sleep apnea (OSA) is a high prevalent disorder with severe consequences including sleepiness, metabolic, and cardiovascular disorders. The aim of this study was to assess the effect of an individualized exercise-training (IET) program with educational sessions vs educational sessions alone on severity markers of OSA over an eight-week duration. METHODS This was a randomised, controlled, parallel-design study. In sum, 64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40 kg/m 2 were included in intervention group (IG) or control group (CG), and 54 patients finished the study. All underwent polysomnography (PSG), multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice. The primary endpoint was the change in apnea-hypopnea (AHI) at eight weeks from baseline. Main secondary endpoints were daytime sleepiness assessed by questionnaire and objective tests. RESULTS No significant between-group differences were found for changes in AHI. A reduction in AHI was found in IG only (p = 0.005). Compared to CG, exercise training leads to a greater decrease in AHI during REM sleep (p = 0.0004), with a significant increase in mean daytime sleep latency (p = 0.02). Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms. CONCLUSIONS In adult patients with moderate-to-severe OSA, IET did not decrease AHI compared to the control group but improved markers of severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness. Adding personalized exercise training to the management of patients with OSA should be considered. CLINICALTRIALS. GOV IDENTIFIER NCT01256307.",2020,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms. ","['64 patients with moderate-to-severe OSA (apnea-hypopnea index AHI 15-45/hour), low physical activity level (Voorrips<9), body-mass index (BMI) <40\xa0kg/m 2 were included in intervention group (IG) or control group (CG), and 54 patients finished the study', 'obstructive sleep apnea syndrome', 'patients with OSA', 'Obstructive sleep apnea (OSA']","['individualized exercise-training (IET) program with educational sessions vs educational sessions alone', 'individualized exercise training program', 'personalized exercise training']","['severity markers of OSA', 'AHI', 'weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms', 'AHI during REM sleep', 'multiple sleep latency test (MSLT), constant workload exercise test, blood samples and fulfilled questionnaires twice', 'mean daytime sleep latency', 'change in apnea-hypopnea (AHI', 'daytime sleepiness assessed by questionnaire and objective tests', 'severity of OSA, in particular AHI in rapid eye movement (REM) sleep and objective daytime sleepiness', 'changes in AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1521798', 'cui_str': 'With trend (attribute)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0519186', 'cui_str': 'Multiple sleep latency test (procedure)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4075948', 'cui_str': 'Sleeps during day (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",64.0,0.01711,"Between-group differences were significant for weight reduction, severity of fatigue, insomnia and depressive symptoms with trend for sleepiness symptoms. ","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bughin', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Desplan', 'Affiliation': 'Specialized Medical Center Medimarien, Marcel Marien Street 21, 1030, Brussels, Belgium; LaboCenter for the Study of Sleep Disorders, Neuroscience Pole, DELTA Hospital, CHIREC, Boulevard of the Triumph 201, 1160, Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mestejanot', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Clinical Research and Epidemiology Unit, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jaffuel', 'Affiliation': 'Department of Pneumology, Arnaud de Villeneuve, Regional University Hospital of Montpellier, 371 Avenue du Doyen Giraud, 34295, Montpellier Cedex 5, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'PhyMedExp INSERM U1046 / CNRS UMR9214, Montpellier University, Montpellier, University Hospital, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jaussent', 'Affiliation': 'INSERM, U1061, Neuropsychiatry, Montpellier, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Unité du Sommeil, Centre National de Référence pour la Narcolepsie, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Montpellier, France; INSERM, U1061, Neuropsychiatry, Montpellier, France; University Montpellier, Montpellier, France. Electronic address: ydauvilliers@yahoo.fr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.008'] 186,31178433,Effects of Treatment of Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes With Metformin Alone or in Combination With Insulin Glargine on β-Cell Function: Comparison of Responses In Youth And Adults.,"β-Cell dysfunction is central to the pathogenesis of impaired glucose tolerance (IGT) and type 2 diabetes. Compared with adults, youth have hyperresponsive β-cells and their decline in β-cell function appears to be more rapid. However, there are no direct comparisons of β-cell responses to pharmacological intervention between the two age-groups. The Restoring Insulin Secretion (RISE) Adult Medication Study and the RISE Pediatric Medication Study compared interventions to improve or preserve β-cell function. Obese youth ( n = 91) and adults ( n = 132) with IGT or recently diagnosed type 2 diabetes were randomized to 3 months of insulin glargine followed by 9 months of metformin, or 12 months of metformin. Hyperglycemic clamps conducted at baseline, after 12 months of medication, and 3 months after medication withdrawal assessed β-cell function as steady-state and maximal C-peptide responses adjusted for insulin sensitivity. Temporal changes in β-cell function were distinctly different. In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups. In adults, β-cell function improved during treatment, but this was not sustained after treatment withdrawal. The difference in β-cell function outcomes in response to medications in youth versus adults supports a more adverse trajectory of β-cell deterioration in youth.",2019,"In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups.","['Obese youth ( n = 91) and adults ( n = 132) with IGT or recently diagnosed type 2 diabetes', 'Youth And Adults']","['insulin glargine', 'metformin, or 12 months of metformin', 'Metformin Alone or in Combination With Insulin Glargine']","['β-cell function', 'Restoring Insulin Secretion (RISE', 'β-cell function as steady-state and maximal C-peptide responses adjusted for insulin sensitivity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",132.0,0.028769,"In youth, β-cell function deteriorated during treatment and after treatment withdrawal, with no differences between treatment groups.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0299'] 187,32289634,Effect of genetic factors on the response to vitamin D 3 supplementation in the VIDARIS randomized controlled trial.,"OBJECTIVES Supplementation provides the best means of improving vitamin D status; however, individual responses vary partly owing to genetics. The aim of this study was to determine whether 28 single nucleotide polymorphisms (SNPs) in six key vitamin D pathway genes (GC, DHCR7, CYP2 R1, CYP24 A1, CYP27 B1, VDR) were associated with differences in response to supplementation. METHODS Participants (N = 313; n = 160 vitamin D, n = 153 placebo) were part of VIDARIS (Vitamin D and Acute Respiratory Infections Study), a double-blind, randomized controlled trial involving oral monthly supplementation of either vitamin D 3 (200 000 IU each for the first 2 mo, thereafter 100 000 IU monthly) or placebo for 18 mo. Circulating 25-hydroxyvitamin D (25[OH]D) concentrations at baseline and 2, 6, 12, and 18 mo, and vitamin D binding protein (Gc-globulin) and calculated free 25(OH)D concentrations at baseline and 2 mo were obtained. Multiple regression was used to model associations between genetic variants and 25(OH)D, Gc-globulin, and free 25(OH)D concentrations. RESULTS SNPs within GC, CYP2 R1, and CYP27 B1 were associated with 25(OH)D concentrations following supplementation. However, only two GC gene SNPs (rs2282679, rs1155563) were significant after adjustment for multiple testing. This effect disappeared after more than 2 mo of supplementation. None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7 (rs12785878), which was associated with reduced free 25(OH)D concentrations in the supplemented arm. CONCLUSION Only variants of GC were associated with 25(OH)D concentrations after supplementation. This effect was modest and disappeared after >2 mo of supplementation, suggesting it may be time/dose-dependent and saturable.",2020,"None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7","['Participants (N\xa0=\xa0313; n\xa0=\xa0160', '28 single nucleotide polymorphisms (SNPs']","['DHCR7', 'vitamin D 3', 'placebo', 'vitamin D, n\xa0=\xa0153 placebo', 'vitamin D 3 supplementation']","['Circulating 25-hydroxyvitamin D (25[OH]D) concentrations', '25(OH)D concentrations', 'free 25(OH)D concentrations', 'vitamin D binding protein (Gc-globulin) and calculated free 25(OH)D concentrations']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042872', 'cui_str': 'GC globulin'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.374094,"None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Slow', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: sandy.slow@otago.ac.nz.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pearson', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Florkowski', 'Affiliation': 'Clinical Biochemistry Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Elder', 'Affiliation': 'Steroid Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lewis', 'Affiliation': 'Steroid Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Murdoch', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110761'] 188,31096264,Influence of Δ9-tetrahydrocannabinol on long-term neural correlates of threat extinction memory retention in humans.,"The neural mechanisms and durability of Δ9-tetrahydrocannabinol (THC) impact on threat processing in humans are not fully understood. Herein, we used functional MRI and psychophysiological tools to examine the influence of THC on the mechanisms of conditioned threat extinction learning, and the effects of THC on extinction memory retention when assessed 1 day and 1 week from learning. Healthy participants underwent threat conditioning on day 1. On day 2, participants were randomized to take one pill of THC or placebo (PBO) 2-h before threat extinction learning. Extinction memory retention was assessed 1 day and 1 week after extinction learning. We found that THC administration increased amygdala and ventromedial prefrontal cortex (vmPFC) activation during early extinction learning with no significant impact on skin conductance responses (SCR). When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network. When extinction memory retention was tested 1 week after learning, the THC group exhibited significantly decreased responses to the extinguished cues within the vmPFC and amygdala, but significantly increased functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex during this extinction retention test. Our results are the first to report a long-term impact of one dose of THC on the functional activation of the threat extinction network and unveil a significant change in functional connectivity emerging after a week from engagement. We highlight the need for further investigating the long-term impact of THC on threat and anxiety circuitry.",2019,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","['humans', 'Healthy participants underwent threat conditioning on day 1']","['Δ9-tetrahydrocannabinol (THC', 'THC', 'Δ9-tetrahydrocannabinol', 'THC or placebo (PBO) 2-h before threat extinction learning']","['extinction memory retention', 'amygdala and ventromedial prefrontal cortex (vmPFC) activation', 'Extinction memory retention', 'functional coupling between the vmPFC, hippocampus, and dorsal anterior cingulate cortex', 'skin conductance responses (SCR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]",,0.0325937,"When extinction memory retention was tested 24 h after learning, the THC group exhibited lower SCRs to the extinguished cue with no significant extinction-induced activations within the extinction network.","[{'ForeName': 'Mira Z', 'Initials': 'MZ', 'LastName': 'Hammoud', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA. mhammoud@uic.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Joshua R B', 'Initials': 'JRB', 'LastName': 'Hatfield', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Rabinak', 'Affiliation': 'Department of Pharmacy Practice and Department of Psychiatry & Behavioral Neuroscience, Wayne State University, Detroit, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0416-6'] 189,32324477,Whey protein supplementation with vibration exercise ameliorates lumbar paraspinal muscle atrophy in prolonged bed rest.,"Optimizing countermeasures for musculoskeletal deterioration during spaceflight is a priority for space agencies. We examined the impact of adding whey protein supplementation to resistive vibration exercise (RVE) on lumbar deconditioning during prolonged bed rest. Participants ( n = 12) were enrolled in a crossover design study of 21 days of bed rest with RVE (2 days/wk, 2-4 min/session time under tension), whey protein supplementation plus RVE (NeX), and no-intervention control (CNT). After bed rest, NeX [-2.2 (7.0)%, P = 0.370], but not RVE [-5.6 (6.4)%, P = 0.0027], reduced paraspinal muscle atrophy compared with CNT [-6.1 (5.5)%, P = 0.00035]. After 3 days of bed rest, whole intervertebral disk (IVD) T2 increased in all groups [CNT: +5.3 (2.5)%, P < 0.0001; NeX: +6.3 (1.8)%, P < 0.0001; RVE: +6.3 (1.9)%, P < 0.0001] and remained at this level on day 21 of bed rest [CNT: 5.5 (2.6)%, P < 0.0001; NeX: 6.0 (1.8)%, P < 0.0001; RVE: 6.2 (2.8)%, P < 0.0001]. Increases in IVD T2 were greatest in the nucleus [10.9 (1.1)%, P < 0.0001], with reductions of T2 observed in the anterior annulus [-4.4 (1.0) %, P = 0.00001] and increases in the posterior annulus [2.1 (0.8)%, P = 0.011]. At 6 and 28 days post-bed rest, IVD T2 was similar compared with baseline for all groups. A similar pattern was seen for IVD height, although a -3.8 (4.6)% ( P = 0.0052) reduction of IVD height was seen 28 days after bed rest in the CNT group. The countermeasures did not impact on the presence or intensity of back pain during or after bed rest. Participants reporting back pain on day 3 of bed rest had greater ( P = 0.013) increases in intervertebral disk volume than participants who did not. Although neither countermeasure impacted IVD changes or back pain in prolonged bed rest, NeX, but not RVE alone, ameliorated paraspinal muscle atrophy. NEW & NOTEWORTHY We examined the impact of adding protein supplementation to exercise (resistive vibration exercise) as a countermeasure against changes in the spine during spaceflight simulation. We found that adding the protein supplementation reduced spine muscle atrophy more than exercise alone. Neither countermeasure approach prevented changes in the disks in the spine or impacted back pain reports.",2020,"Following bed-rest, NeX (‑2.2[7.0]%, P=0.370), but not RVE (‑5.6[6.4]%, P=0.0027), reduced paraspinal muscle atrophy compared to CNT (-6.1[5.5]%, P=0.00035).","['lumbar deconditioning during prolonged bed-rest', 'Participants (n=12) were enrolled in a cross-over design 21d bed-rest with RVE (2d/wk, 2-4min/session time-under-tension']","['whey protein supplementation to resistive vibration exercise (RVE', 'whey protein supplementation plus RVE (NeX) and no-intervention control (CNT', 'vibration exercise']","['IVD T2', 'reduced paraspinal muscle atrophy', 'presence or intensity of back pain', 'intervertebral disc (IVD) T2', 'IVD changes or back pain', 'intervertebral disc volume', 'IVD height']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",12.0,0.0560852,"Following bed-rest, NeX (‑2.2[7.0]%, P=0.370), but not RVE (‑5.6[6.4]%, P=0.0027), reduced paraspinal muscle atrophy compared to CNT (-6.1[5.5]%, P=0.00035).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Owen', 'Affiliation': 'Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Geelong, Victoria, Australia.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Armbrecht', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bansmann', 'Affiliation': 'Krankenhaus Porz am Rhein, Institute for Diagnostic and Interventional Radiology, Krankenhaus Porz am Rhein, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Zange', 'Affiliation': 'German Aerospace Centre, DLR e.V., Linder Höhe, Cologne, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Pohle-Fröhlich', 'Affiliation': 'Hochschule Niederrhein, Graphische Datenverarbeitung und Bildverarbeitung, Krefeld, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Belavý', 'Affiliation': 'Deakin University, Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Geelong, Victoria, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00125.2020'] 190,30858518,Lithium continuation therapy following ketamine in patients with treatment resistant unipolar depression: a randomized controlled trial.,"The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t 32  = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.",2019,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"['Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5\u2009mg/kg', 'subjects with TRD', 'patients with treatment resistant unipolar depression (TRD', 'patients with treatment resistant unipolar depression', 'Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization']","['ketamine', 'matching placebo', 'ketamine and lithium', 'placebo', 'lithium or placebo', 'daily oral lithium', 'N-methyl-D-aspartate (NMDA) receptor antagonist ketamine', 'Lithium continuation therapy', 'lithium and placebo', 'lithium or matching placebo']","['depression severity', 'depression severity as measured by the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521484', 'cui_str': 'N-methyl-D-aspartate receptor antagonist (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",34.0,0.668127,There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Costi', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Laili', 'Initials': 'L', 'LastName': 'Soleimani', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glasgow', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'Brallier', 'Affiliation': 'Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Spivack', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Levitch', 'Affiliation': 'Department of Psychology, Fordham University, Bronx, NY, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hoch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wade', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Welch', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Feder', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Charney', 'Affiliation': 'Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Depression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA. james.murrough@mssm.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0365-0'] 191,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease. METHODS We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. RESULTS At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03). CONCLUSIONS Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03). ","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03). ","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925'] 192,31723064,"Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.","BACKGROUNDIL-33, found in high levels in participants with allergic disorders, is thought to mediate allergic reactions. Etokimab, an anti-IL-33 biologic, has previously demonstrated a good safety profile and favorable pharmacodynamic properties in many clinical studies.METHODSIn this 6-week placebo-controlled phase 2a study, we evaluated the safety and the ability of a single dose of etokimab to desensitize peanut-allergic adults. Participants received either etokimab (n = 15) or blinded placebo (n = 5). Clinical tests included oral food challenges and skin prick tests at days 15 and 45. Blood samples were collected for IgE levels and measurement of ex vivo peanut-stimulated T cell cytokine production.RESULTSEfficacy measurements for active vs. placebo participants at the day 15 and 45 food challenge (tolerating a cumulative 275 mg of peanut protein, which was the food challenge outcome defined in this paper) demonstrated, respectively, 73% vs. 0% (P = 0.008) to 57% vs. 0% (ns). The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.TRIAL REGISTRATIONClinicalTrials.gov NCT02920021.FUNDINGThis work was supported by NIH grant R01AI140134, AnaptysBio, the Hartman Vaccine Fund, and the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.",2019,"The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.","['participants with allergic disorders', 'peanut allergy', 'allergic adults']","['etokimab to desensitize peanut', 'etokimab', 'anti-IL-33', 'placebo', 'blinded placebo']","['adverse events', 'IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells', 'oral food challenges and skin prick tests', 'T cell activation', 'safe and well tolerated']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C3540587', 'cui_str': 'IL33'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0085424', 'cui_str': 'Interleukin-9'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}]",,0.429833,"The etokimab group had fewer adverse events compared with placebo. IL-4, IL-5, IL-9, IL-13, and ST2 levels in CD4+ T cells were reduced in the active vs. placebo arm upon peanut-induced T cell activation (P = 0.036 for IL-13 and IL-9 at day 15), and peanut-specific IgE was reduced in active vs. placebo (P = 0.014 at day 15).CONCLUSIONThe phase 2a results suggest etokimab is safe and well tolerated and that a single dose of etokimab could have the potential to desensitize peanut-allergic participants and possibly reduce atopy-related adverse events.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Lyu', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Long', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Vanitha', 'Initials': 'V', 'LastName': 'Sampath', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petroni', 'Affiliation': 'ASTHMA Inc., Clinical Research Center, Northwest Asthma and Allergy Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Londei', 'Affiliation': 'AnaptysBio Inc., San Diego, California, USA.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research at Stanford University.'}]",JCI insight,['10.1172/jci.insight.131347'] 193,31430023,Widespread higher fractional anisotropy associates to better cognitive functions in individuals at ultra-high risk for psychosis.,"In schizophrenia patients, cognitive functions appear linked to widespread alterations in cerebral white matter microstructure. Here we examine patterns of associations between regional white matter and cognitive functions in individuals at ultra-high risk for psychosis. One hundred and sixteen individuals at ultra-high risk for psychosis and 49 matched healthy controls underwent 3 T magnetic resonance diffusion-weighted imaging and cognitive assessments. Group differences on fractional anisotropy were tested using tract-based spatial statistics. Group differences in cognitive functions, voxel-wise as well as regional fractional anisotropy were tested using univariate general linear modeling. Multivariate partial least squares correlation analyses tested for associations between patterns of regional fractional anisotropy and cognitive functions. Univariate analyses revealed significant impairments on cognitive functions and lower fractional anisotropy in superior longitudinal fasciculus and cingulate gyrus in individuals at ultra-high risk for psychosis. Partial least squares correlation analysis revealed different associations between patterns of regional fractional anisotropy and cognitive functions in individuals at ultra-high risk for psychosis compared to healthy controls. Widespread higher fractional anisotropy was associated with better cognitive functioning for individuals at ultra-high risk for psychosis, but not for the healthy controls. Furthermore, patterns of cognitive functions were associated with an interaction-effect on regional fractional anisotropy in fornix, medial lemniscus, uncinate fasciculus, and superior cerebellar peduncle. Aberrant associations between patterns of cognitive functions to white matter may be explained by dysmyelination.",2019,Univariate analyses revealed significant impairments on cognitive functions and lower fractional anisotropy in superior longitudinal fasciculus and cingulate gyrus in individuals at ultra-high risk for psychosis.,"['One hundred and sixteen individuals at ultra-high risk for psychosis and 49 matched healthy controls underwent 3', 'individuals at ultra-high risk for psychosis']",['T magnetic resonance diffusion-weighted imaging and cognitive assessments'],"['cognitive functions, voxel-wise as well as regional fractional anisotropy', 'cognitive functioning', 'cognitive functions', 'regional fractional anisotropy in fornix, medial lemniscus, uncinate fasciculus, and superior cerebellar peduncle', 'fractional anisotropy']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0228420', 'cui_str': 'Medial lemniscus structure'}, {'cui': 'C0228271', 'cui_str': 'Structure of uncinate fasciculus'}, {'cui': 'C0152391', 'cui_str': 'Structure of superior cerebellar peduncle'}]",116.0,0.0278556,Univariate analyses revealed significant impairments on cognitive functions and lower fractional anisotropy in superior longitudinal fasciculus and cingulate gyrus in individuals at ultra-high risk for psychosis.,"[{'ForeName': 'Tina D', 'Initials': 'TD', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen Research Center for Mental Health, CORE, Mental Health Centre Copenhagen, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'René C W', 'Initials': 'RCW', 'LastName': 'Mandl', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jayachandra M', 'Initials': 'JM', 'LastName': 'Raghava', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Jessen', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jens Richardt M', 'Initials': 'JRM', 'LastName': 'Jepsen', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Fagerlund', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Louise B', 'Initials': 'LB', 'LastName': 'Glenthøj', 'Affiliation': 'Copenhagen Research Center for Mental Health, CORE, Mental Health Centre Copenhagen, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wenneberg', 'Affiliation': 'Copenhagen Research Center for Mental Health, CORE, Mental Health Centre Copenhagen, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Krakauer', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Pantelis', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Copenhagen Research Center for Mental Health, CORE, Mental Health Centre Copenhagen, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Birte Y', 'Initials': 'BY', 'LastName': 'Glenthøj', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Bjørn H', 'Initials': 'BH', 'LastName': 'Ebdrup', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, CINS, and Center for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}]",Human brain mapping,['10.1002/hbm.24765'] 194,32328953,Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c ≤ 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials.,"INTRODUCTION Clinical guidelines suggest a glycated hemoglobin A1c (HbA1c) target of ≤ 6.5% for type 2 diabetes patients with short duration of disease, few comorbidities and/or long life expectancy-provided this goal can be achieved safely. We explored whether initial combination treatment with the dipeptidyl peptidase-4 inhibitor linagliptin and metformin could provide better glycemic control (HbA1c ≤ 6.5%) than metformin alone without increasing hypoglycemia. METHODS We pooled and analyzed individual patient data from two randomized clinical trials of early combination therapy with linagliptin and metformin versus metformin monotherapy. The primary outcome in both trials was the change in HbA1c from baseline to week 24. We evaluated the percentage of patients who achieved HbA1c ≤ 6.5% at week 24 and the incidence of adverse events. RESULTS Most (> 70%) of the 1160 patients analyzed were treatment naive, and more than half had had diabetes for ≤ 1 year; mean baseline HbA1c was approximately 8.7%. Combination therapy with linagliptin and metformin resulted in more patients achieving HbA1c ≤ 6.5% than metformin alone, both for a metformin dose of 500 mg (40.1 vs. 22.9%, respectively, odds ratio [OR] 2.84, 95% confidence interval [CI] 1.87-4.32) and 1000 mg (49.5 vs. 35.4%, respectively, OR 2.28, 95% CI 1.54-3.40). Hypoglycemia occurred in < 3% of patients, with a comparable incidence between treatment groups. Other adverse events were also balanced between groups. CONCLUSION Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events. TRIAL REGISTRATION ClinicalTrials.gov, NCT00798161 and NCT01708902.",2020,"Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events. ",['People with Type 2 Diabetes Improves Glycemic Control to HbA1c\u2009≤\u20096.5% without Increasing Hypoglycemia'],"['linagliptin and metformin', 'dipeptidyl peptidase-4 inhibitor linagliptin and metformin', 'linagliptin and metformin versus metformin monotherapy', 'Linagliptin and Metformin', 'metformin']","['Hypoglycemia', 'incidence of adverse events', 'chances of achieving tight glycemic control']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.174094,"Early combination treatment with linagliptin and metformin can improve the chances of achieving tight glycemic control (HbA1c ≤ 6.5%) without increasing the risk of hypoglycemia or other adverse events. ","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Lilly (Shanghai) Management Co. Ltd, Shanghai, China.'}, {'ForeName': 'Binqi', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Schepers', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Plat', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China. young.stone@163.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00819-9'] 195,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND Some weight loss medications, including liraglutide 3.0 mg, are thought to facilitate weight loss by improving appetite control. However, no studies have evaluated their long-term appetitive effects. SUBJECTS/METHODS This study examined changes in appetite in a subsample of 113 adults with obesity (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) who participated in a 52-week trial. Participants were randomized to intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0 mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). Participants rated their hunger, fullness after meals, liking of meals, and food preoccupation (all as experienced over the past week) using visual analogue scales (0-100 mm). Ratings were completed at baseline and eight subsequent visits over the year. RESULTS At week 52, participants treated by IBT-alone lost 6.2 ± 1.6% of baseline weight, compared with 11.8 ± 1.6% and 12.1 ± 1.5% in the IBT-liraglutide and Multi-component groups, respectively. Compared to IBT-alone, IBT-liraglutide participants reported larger reductions at week 6 in hunger (-0.3 ± 4.2 vs -16.8 ± 4.0 mm, p = .005) and food preoccupation (+0.2 ± 3.7 vs -16.3 ± 3.6 mm, p = .002) and larger increases in fullness (-5.1 ± 3.2 vs +9.8 ± 3.0 mm, p = .001). These significant differences persisted at all assessments through week 24. There were no differences between IBT-alone and IBT-liraglutide in meal liking. IBT-alone and Multi-component participants differed in hunger at week 6, and in food preoccupation at all assessments through week 24. Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively. There were no other differences among any groups at week 52. CONCLUSIONS Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6'] 196,31971139,Treatment of Sick Children Seeking Care in the Private Health Sector in Uganda: A Cluster Randomized Trial.,"The main objective of this study was to assess whether training of private health providers and community sensitization on the importance of effective prompt care seeking and the need for referral could improve treatment of sick children in the private health sector in Uganda. Private providers were trained to diagnose and treat sick children according to the integrated community case management (iCCM) guidelines. In the control arm, routine services were offered. The outcomes were seeking care within 24 hours of onset of symptoms and appropriate case management for malaria, pneumonia, and diarrhea among children aged < 5 years. A total of 10,809 sick children (5,955 in the intervention arm and 4,854 in the control arm) presented for diagnosis and treatment. The percentage seeking care within 24 hours of onset of symptoms was 45.4% (95% CI 36.0-48.8) in the intervention arm versus 43.9% (95% CI 38.1-49.8) in the control arm ( P = 0.04). Adherence to malaria rapid diagnostic test (mRDT) results was high, with 1,459 (94.3%) in the intervention arm versus 1,402 (83.0%) in the control arm ( P = 0.04). Appropriate treatment of mRDT-positive children with artemisinin-based combination therapy was seen in 93.1% (95% CI 88.5-97.7) in the intervention arm versus 85.1% (95% CI 78.6-91.7) in the control arm ( P = 0.03). Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc ( P = 0.01). Of the children with a respiratory rate > 40 breaths/minute, 1,596 (85.1%) in the intervention arm versus 104 (54.5%) in the control arm were given amoxicillin ( P = 0.01). In conclusion, the intervention improved treatment of malaria, pneumonia, and diarrhea because of provider adherence to treatment guidelines. The policy implications of these findings are to initiate a dialogue at district and national levels on how to scale up the intervention in the private sector. NCT02450630 registered with ClinicalTrials.gov: May 9, 2015.",2020,Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc (,"['10,809 sick children (5,955 in the intervention arm and 4,854 in the control arm) presented for diagnosis and treatment', 'sick children in the private health sector in Uganda', 'Sick Children Seeking Care in the Private Health Sector in Uganda', 'children aged < 5 years']","['oral rehydration salts and zinc ', 'amoxicillin ']","['diarrhea', 'percentage seeking care', 'malaria, pneumonia, and diarrhea', 'malaria, pneumonia, and diarrhea because of provider adherence']","[{'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086904', 'cui_str': 'Oral Rehydration'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",10809.0,0.0716126,Adherence to iCCM guidelines was very high: 89.1% of children with diarrhea in the intervention arm and 80.4% in the control arm were given oral rehydration salts and zinc (,"[{'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Mbonye', 'Affiliation': 'School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Buregyeya', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Elizeus', 'Initials': 'E', 'LastName': 'Rutebemberwa', 'Affiliation': 'Department of Health Policy, Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sham', 'Initials': 'S', 'LastName': 'Lal', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Siân E', 'Initials': 'SE', 'LastName': 'Clarke', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kristian S', 'Initials': 'KS', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health and Centre for Health Economics and Policy, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Magnussen', 'Affiliation': 'Institute for Immunology and Microbiology, Centre for Medical Parasitology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'LaRussa', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0367'] 197,30940887,The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.,"PURPOSE In this study we compared the anatomic and functional outcomes of two steroid treatments on rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD), namely treatment with oral prednisolone (1 mg/kg daily) for 3-7 days before vitrectomy or a single periocular injection of methylprednisolone (40 mg) 1-3 days before vitrectomy. We also analyzed the outcomes of the eyes with subsided CD and the eyes with persistent CD that underwent drainage of suprachoroidal fluids during the vitrectomy. METHODS This was a prospective randomized study. Seventy five eyes with RRD combined with CD were divided into 2 groups based on the two different treatment regimens as above. The eyes in each group were further divided into 2 subgroups (A: CD subsided eyes; B: CD persistent eyes) according to the response of CD to the treatment of steroids. Retinal reattachment rates were measured at 6 months after the removal of silicone oil. RESULTS At 6 months after silicone oil removal, the retinal reattachment rate was similar (p = 0.666) in the oral prednisolone group (91.7%, 33/36) and the periocular injection group (94.9%, 37/39). Similar retinal reattachment rates (p = 0.364) were also found in the CD subsided eyes (97.1%, 34/35) and the CD persistent eyes (90.0%, 36/40). The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25). CONCLUSIONS For RRD combined with CD, eyes treated with a single periocular injection of methylprednisolone (40 mg, 1-3 days before pars plana vitrectomy) combined with the drainage of suprachoroidal fluids during the surgery had similar anatomic and functional outcomes compared to the eyes treated with oral prednisolone for 3-7 days before vitrectomy.",2019,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25). ","['rhegmatogenous retinal detachment combined with choroidal detachment', 'Seventy five eyes with RRD combined with CD']","['methylprednisolone and drainage of suprachoroidal fluid', 'oral prednisolone', 'methylprednisolone', 'rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD', 'steroid treatments', 'silicone oil', 'prednisolone']","['retinal reattachment rate', 'Retinal reattachment rates', 'Similar retinal reattachment rates']","[{'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0395611', 'cui_str': 'Drainage of suprachoroidal fluid (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0162279', 'cui_str': 'Choroidal detachment (disorder)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}]","[{'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0185042', 'cui_str': 'Refixation (procedure)'}]",75.0,0.0482548,"The retinal reattachment rate was comparable among the subgroups (p = 0.395; oral prednisolone A group: 95.2%, 20/21; oral prednisolone B group: 86.7%, 13/15; periocular injection A group: 100%, 14/14; periocular injection B group: 92.0%, 23/25). ","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China. weiyongdoctor@163.com.'}, {'ForeName': 'RongLe', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ""Shaanxi Ophthalmic Medical Center, Xi'an No.4 Hospital, Affiliated Guangren Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an, 710004, China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Xiuju', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Xiamen Eye Center Affiliated to Xiamen University, Xiamen, 361000, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325027, China.'}]","Eye (London, England)",['10.1038/s41433-019-0420-4'] 198,32326201,Fear of the Relapse: Effect of Composite Type on Adhesion Efficacy of Upper and Lower Orthodontic Fixed Retainers: In Vitro Investigation and Randomized Clinical Trial.,"The aim of this laboratory and clinical study is to determine the reliability of the flowable nanocomposite Filtek Supreme XTE (FL) for the adhesion of orthodontic retainers, compared to highly filled orthodontic resin Transbond XT (XT). Portions of a round section multistranded wire (Ortosmail Krugg) were bonded to 40 bovine incisors with Scotchbond Universal in total-etch modality. For group one (XT, 20 samples), the orthodontic resin was used, whereas in group two (FL, 20 samples), the flowable one. Specimens were placed into a universal testing machine which applied a shear force on retainers with a crosshead speed of one/minute. Shear bond strength (SBS) and adhesive remnant index (ARI) scores were calculated. In the clinical trial, 100 patients requiring a canine-to-canine palatal and lingual retainer were randomly divided into two groups, according to the resin used for bonding procedure: the orthodontic in group one (XT, 50 participants) and the flowable in group two (FL, 50 participants). Monthly visits were carried out over a 24-month follow up to assess any detachment occurring on teeth of both arches. All data were submitted to statistical analysis. In vitro, FL reported a significant lower mean SBS, whereas no significant differences in ARI were reported between the two groups which both showed a major frequency of scores ""1"" and ""2"". At the end of the 24-month follow up, FL reported significantly higher failure rates in both arches besides a significantly lower survival rate starting from the sixth month after retainers bonding. According to the results assessed in vitro and clinically, XT would be preferable to FL when performing retainers bonding procedure.",2020,"At the end of the 24-month follow up, FL reported significantly higher failure rates in both arches besides a significantly lower survival rate starting from the sixth month after retainers bonding.","['100 patients requiring a canine-to-canine palatal and lingual retainer', 'Upper and Lower Orthodontic Fixed Retainers']","['Composite Type', 'flowable nanocomposite Filtek Supreme XTE (FL', 'round section multistranded wire (Ortosmail Krugg']","['failure rates', 'ARI', 'Shear bond strength (SBS) and adhesive remnant index (ARI) scores', 'survival rate', 'mean SBS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1721059', 'cui_str': 'Nanocomposites'}, {'cui': 'C1258329', 'cui_str': 'Filtek Supreme'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",100.0,0.0237049,"At the end of the 24-month follow up, FL reported significantly higher failure rates in both arches besides a significantly lower survival rate starting from the sixth month after retainers bonding.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scribante', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Turcato', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Trovati', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gandini', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Sfondrini', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, 27100 Pavia, Italy.'}]",Polymers,['10.3390/polym12040963'] 199,32279030,Effects of using high-intensity interval training and calorie restriction in different orders on metabolic syndrome: A randomized controlled trial.,"OBJECTIVE Studies of the effectiveness of high-intensity interval training (HIIT) combined with calorie restriction (CR) are very limited, and the most effective order of intervention is unclear. Therefore, we investigated the impact of time-efficient HIIT with CR intervention on metabolic syndrome (MetS) and the impact of the intervention order on changes in MetS risk factors. METHODS Thirty-two participants with MetS underwent an 11-wk intervention program comprising 8 wk of HIIT and 3 wk of CR. Participants were randomly assigned to either the HIIT-then-CR or CR-then-HIIT groups. Thereafter, the CR-then-HIIT group performed a further 8 wk of training once per week after the initial intervention period. Risk factors for MetS and peak oxygen uptake (VO 2peak ) were assessed during the entire study period. RESULTS During the 11-wk intervention period, body composition, MetS risk factors, and VO2 peak significantly improved in both groups. No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group. During the postintervention period (8 wk), a single weekly HIIT session prevented VO 2peak reduction in the CR-then-HIIT group (-2.0 ± 7.2%; P = 0.31). CONCLUSIONS The time-efficient intervention program with HIIT and CR had a beneficial effect on MetS; however, the intervention order had no influence on the changes in risk factors.",2020,"No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group.","['Thirty-two participants with MetS underwent an 11-wk intervention program comprising 8 wk of HIIT and 3 wk of CR', 'metabolic syndrome']","['high-intensity interval training (HIIT) combined with calorie restriction (CR', 'high-intensity interval training and calorie restriction', 'CR intervention']","['body composition, MetS risk factors, and VO2 peak', 'Risk factors for MetS and peak oxygen uptake (VO 2peak ', 'metabolic syndrome (MetS']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",32.0,0.0341696,"No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group.","[{'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Occupational Epidemiology Research Group, National Institute of Occupational Safety and Health, Japan. Kwasaki, Japan; Research Center for Overwork-Related Disorders, National Institute of Occupational Safety and Health, Japan. Kawasaki, Japan. Electronic address: sorina@crf-res.net.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'Occupational Epidemiology Research Group, National Institute of Occupational Safety and Health, Japan. Kwasaki, Japan; Research Center for Overwork-Related Disorders, National Institute of Occupational Safety and Health, Japan. Kawasaki, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110666'] 200,32279360,Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study.,"AIMS AND OBJECTIVES To measure the effect of chair resistance training (RT) on the quality of life (QoL) of older long-term care residents with sarcopenic obesity (SO). BACKGROUND Sarcopenia combined with obesity, commonly called SO, is considered to be related to health-related QoL. Despite concerns regarding SO-related long-term healthcare issues, intervention studies on SO residents in nursing homes are scant in Taiwan. DESIGN This research was a quasi-experiment conducted according to the TREND Checklist. A total of 123 older persons were enrolled from six nursing facilities. The RT was implemented between October 2015-March 2016. METHOD The intervention group received progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care. QoL was the major outcome variable. Data were analysed using chi-square test, Student's t test and generalised estimating equation (GEE). RESULTS The various definition criteria for SO can influence the results of QoL in the older persons. From the body composition perspective, in the GEE analysis, the SO cut-off points for neither skeletal muscle mass percentage (SMMp) nor appendicular skeletal muscle mass index demonstrated significant between-group differences in the QoL variable after the 3-month RT intervention. Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value < .05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity). RT was one of the protective factors. CONCLUSION In the SO group, the effect of muscle strength on QoL is greater than the effect of changes in body composition after RT. RELEVANCE TO CLINICAL PRACTICE This study analysed the influence of RT on QoL in subjects with different categories of SO. RT is one of the ways to promote QoL among the SO population. ClinicalTrials.gov Identifier: NCT02912338.",2020,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","['123 older persons were enrolled from six nursing facilities', 'older people with sarcopenic obesity living in long-term care institutions', 'subjects with different categories of SO', 'elderly long-term care residents with sarcopenic obesity (SO', 'older persons']","['progressive RT with sandbags/dumbbells twice a week for 3 months, whereas the comparison group received the usual care', 'resistance training', 'chair resistance training (RT']","['quality of life (QoL', 'time on anxiety/depression', 'quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179847', 'cui_str': 'Chair'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",123.0,0.0452616,"Between-group analysis revealed a significant effect of time on anxiety/depression [Exp(B): 0.41, 95% confidence interval: 0.18-0.93, p-value <0.05] in participants who met all three criteria of the definition of SO (low SMMp, low handgrip strength, and obesity).","[{'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, ROC.'}, {'ForeName': 'Shu-Ching', 'Initials': 'SC', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing & Health Sciences, Taipei, Taiwan, ROC.'}]",Journal of clinical nursing,['10.1111/jocn.15277'] 201,32311627,Women's experience of induction of labor using PGE2 as an inpatient versus balloon catheter as an outpatient.,"OBJECTIVE Induction of labor (IOL) typically involves cervical priming in an inpatient setting. Outpatient cervical priming may be a safe and cost-effective alternative. However, little is known about women's preference and the impact of outpatient cervical priming on their healthcare experience. The objective was to compare women's healthcare experiences following IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient. STUDY DESIGN A randomized controlled trial was undertaken across eight Australian maternity hospitals. Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies were randomized. Of these, 215 and 233 women in the balloon-outpatient and PG-inpatient groups, respectively, received the allocated intervention. The PG group received Dinoprostone gel or controlled-release tape. The balloon group had a double-balloon catheter inserted and went home. Experiential and quality-of-life outcomes were measured via written questionnaire after birth. The primary outcome was a composite neonatal measure. Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores are reported here. RESULTS Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation. More women in the balloon-outpatient group reported they would choose IOL next pregnancy (49.2 % vs 38.4 %; p = 0.037) and desire the same method (72.4 % vs 61.1 %; p = 0.022). The balloon-outpatient group experienced higher pain scores at the start of IOL (median (IQR) 3(2-5) vs 2(1-4); p = 0.002) but lower scores at time of rupture of membranes (3(1-5) vs 4(2-6); p = 0.007). The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899). CONCLUSIONS Women report similar healthcare experiences following balloon-outpatient compared to PG-impatient IOL, but are more likely to desire the same method next pregnancy if IOL is required. If both options are available, then differences in experience should be shared with women, alongside differences in clinical outcomes as part of their decision-making process.",2020,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899). ","['215 and 233 women in the balloon-outpatient and PG-inpatient groups', 'Questionnaire data were available for 366 (81.7 %) women enrolled who received their treatment allocation', 'Between September 2015 and October 2018, 695 women with uncomplicated term singleton pregnancies', 'eight Australian maternity hospitals']","['double-balloon catheter inserted and went home', 'IOL using a balloon catheter and going home, versus prostaglandin (PG) and remaining an inpatient', 'Dinoprostone gel or controlled-release tape']","['EQ-5D-3 L health-utility index', 'IOL next pregnancy', ""Women's healthcare experience, health-state (EQ-5D-3 L) and pain scores"", 'Experiential and quality-of-life outcomes', 'composite neonatal measure', 'pain scores']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",695.0,0.164063,"The EQ-5D-3 L health-utility index did not differ significantly between the groups (0.77 vs 0.78; p = 0.899). ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Mater Health, Queensland, Australia; University of Queensland, School of Medicine, Queensland, Australia; Mater Research, The University of Queensland, Queensland, Australia. Electronic address: Michael.Beckmann@mater.org.au.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Acreman', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Mater Health, Queensland, Australia.'}, {'ForeName': 'Katharina M D', 'Initials': 'KMD', 'LastName': 'Merollini', 'Affiliation': 'University of the Sunshine Coast, School of Health and Sport Sciences, Queensland, Australia.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Miller', 'Affiliation': 'Queensland University of Technology, Queensland, Australia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.03.031'] 202,31311668,A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env.,"PURPOSE Temelimab/GNbAC1 is a humanized immunoglobulin G4 monoclonal antibody antagonist of the human endogenous retrovirus W envelope protein, which is associated with multiple sclerosis (MS) pathophysiology and possibly with other autoimmune disorders. Human endogenous retrovirus W envelope protein is expressed in the central nervous system of patients with MS, and sufficient amount of temelimab must reach the target. The safety of very high dosages of temelimab should be tested to support further clinical trials in MS. METHODS This randomized, placebo-controlled, dose-escalation study evaluated the safety and pharmacokinetic profile of temelimab in 24 healthy volunteers after a single intravenous infusion at doses of 36, 60, 85, and 110 mg/kg administered sequentially. FINDINGS Temelimab was well tolerated, with no particular adverse drug reactions at any dose. The maximal dose of 110 mg/kg could be administered, and no antidrug antibodies were induced. After administration of 36-110 mg/kg, mean temelimab C max increased from 859 to 2450 μg/mL, and AUC values increased from 319,900 to 1,030,000 μg·h/mL. There was an approximate dose-proportional increase in exposure, similar to observations at lower doses. IMPLICATIONS The favorable data in terms of safety and pharmacokinetic variables support temelimab use at high doses in future MS trials to optimally neutralize the temelimab target in the central nervous system. ClinicalTrials.gov identifier: NCT03574428.",2019,"After administration of 36-110 mg/kg, mean temelimab C max increased from 859 to 2450 μg/mL, and AUC values increased from 319,900 to 1,030,000 μg·h/mL. There was an approximate dose-proportional increase in exposure, similar to observations at lower doses. ","['24 healthy volunteers after a single intravenous infusion at doses of 36, 60, 85, and 110\xa0mg/kg administered sequentially']","['41:XXX-XXX', 'placebo']","['mean temelimab C max', 'AUC values']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",24.0,0.0593703,"After administration of 36-110 mg/kg, mean temelimab C max increased from 859 to 2450 μg/mL, and AUC values increased from 319,900 to 1,030,000 μg·h/mL. There was an approximate dose-proportional increase in exposure, similar to observations at lower doses. ","[{'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Porchet', 'Affiliation': 'GeNeuro SA, Chemin Pré-Fleuri, Plan-les-Ouates, Geneva, Switzerland; Department of Pharmacology, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Vidal', 'Affiliation': 'GeNeuro SA, Chemin Pré-Fleuri, Plan-les-Ouates, Geneva, Switzerland.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Kornmann', 'Affiliation': 'GeNeuro SA, Chemin Pré-Fleuri, Plan-les-Ouates, Geneva, Switzerland.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Malpass', 'Affiliation': 'Southern Star Research Pty Ltd, Gordon, New South Wales, Australia.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Curtin', 'Affiliation': 'GeNeuro SA, Chemin Pré-Fleuri, Plan-les-Ouates, Geneva, Switzerland; Division of Clinical Pharmacology and Toxicology, University of Geneva, Geneva, Switzerland. Electronic address: fc@geneuro.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.05.020'] 203,31971158,Does a Free-Trial Approach Increase Purchase and Use of a Household Water Treatment and Safe Storage Product in Rural Haiti?,"A cluster, randomized control trial was conducted to assess the effects of social marketing approach on purchase rates and water treatment behavior of Klorfasil, a chlorine-based household water treatment product among seven villages in Thomassique, Haiti, from May to December 2016. Villages were randomized to the free-trial (257 households) or cost-sharing (240 households) group. Households in the free-trial group were allowed 30 days of free Klorfasil use before purchase decision. Households who purchased Klorfasil were then followed up for 30, 60, and 180 days. At the last follow-up, respondents were asked if they would like to repurchase Klorfasil. Questionnaire survey and water quality assessment by residual-free chlorine were conducted in each survey. Chi-square test, t -test, and logistic regression were applied. The first purchase rate of the cost-sharing group was significantly higher than that of the free-trial group (79.2% versus 67.3%). By contrast, the repurchase rate of the free-trial group was higher (82.9% versus 66.3%). However, the overall repurchase rate was 71.6% and the proportion of long-term users was significantly higher in the cost-sharing group (56% versus 47%). Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32). Households with high and medium economic status both had significantly higher purchase rates than low economic status households (OR = 4.40, OR = 1.94). Households with higher educated respondents had significantly better water treatment practices (OR = 2.15). The free-trial approach did not increase the first purchase rate but increased the repurchase rate later. The cost-sharing approach significantly encouraged long-term usage.",2020,"Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32).","['seven villages in Thomassique, Haiti, from May to December 2016']",['social marketing approach'],"['overall repurchase rate', 'repurchase rate', 'Questionnaire survey and water quality assessment', 'purchase rates']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",257.0,0.0300443,"Water treatment rates in the cost-sharing group were significantly higher than those in the free-trial group in the first and final surveys (odds ratio [OR] = 0.15, OR = 0.32).","[{'ForeName': 'Feng-Jen', 'Initials': 'FJ', 'LastName': 'Tsai', 'Affiliation': 'Master Program in Global Health and Development, College of Public Health, Taipei Medical University, Taipei City, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Chia-Ping', 'Initials': 'CP', 'LastName': 'Lin', 'Affiliation': 'Master Program in Global Health and Development, College of Public Health, Taipei Medical University, Taipei City, Taiwan.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0606'] 204,31826336,"Early High-Dose Vitamin D 3 for Critically Ill, Vitamin D-Deficient Patients.","BACKGROUND Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. METHODS We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D 3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D 3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality. RESULTS A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality. CONCLUSIONS Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients. (Funded by the National Heart, Lung, and Blood Institute; VIOLET ClinicalTrials.gov number, NCT03096314.).",2019,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","['critically ill, vitamin D-deficient patients who were at high risk for death', 'Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population', '1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization', 'critically ill, vitamin D-deficient patients', 'Critically Ill, Vitamin D-Deficient Patients', 'critically ill patients']","['single enteral dose of 540,000 IU of vitamin D 3 or matched placebo', 'vitamin D supplementation', 'placebo', 'early vitamin D 3 supplementation', 'vitamin D']","['90-day mortality', '90-day mortality or other, nonfatal outcomes', '90-day all-cause, all-location mortality', 'mean day 3 level of 25-hydroxyvitamin D', 'severity of vitamin D deficiency']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]",1360.0,0.763031,"Early administration of high-dose enteral vitamin D 3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D-deficient patients.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Caterino', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Lani', 'Initials': 'L', 'LastName': 'Finck', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Hyzy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Levitt', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ringwood', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'Rivers', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Talmor', 'Affiliation': 'The affiliations of the members of the writing committee are as follows: the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G., L.F.); the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B.); the Department of Emergency Medicine, Ohio State University, Columbus (J.M.C.); the Departments of Anesthesia, Critical Care, and Pain Medicine (V.M.B.-G., D.T.) and Emergency Medicine (N.I.S.), Beth Israel Deaconess Medical Center, and the Biostatistics Center (D.H.) and the Department of Medicine (N.R., B.T.T.), Massachusetts General Hospital - all in Boston; the Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City (C.K.G.); the Department of Medicine, University of Washington, Seattle (C.L.H.); the Departments of Medicine (R.C.H.) and Surgery (P.K.P.), University of Michigan, Ann Arbor; the Department of Emergency Medicine and Surgery, Henry Ford Hospital, Detroit (E.P.R.); the Department of Medicine, Oregon Health and Science University, Portland (A.K.); the Department of Medicine, Stanford University, Palo Alto, CA (J.E.L.); the Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville (W.H.S.); and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911124'] 205,31264451,An online randomised controlled trial of mental contrasting with implementation intentions as a smoking behaviour change intervention.,"Objective: We assessed the effectiveness of mental contrasting with implementation intentions (MCII), an established self-regulatory strategy, as a brief online smoking behaviour change intervention. We expected that MCII would enhance smoking reduction among the highly cigarette dependent because MCII is most effective for challenging pursuits. Design: Participants interested in reducing or quitting smoking were recruited online via Amazon Mechanical Turk. At Time 1, we assessed cigarette dependence using the Cigarette Dependence Scale (CDS-5), then administered one of two brief self-help interventions: MCII ( n  = 172) or a government-promoted control strategy ( n  = 174). Participants were invited to complete an online follow-up survey 4 weeks later (Time 2). Main Outcome Measure: At Time 1 and Time 2, we measured recent cigarette smoking with a retrospective, self-report questionnaire. We used these reports to compute smoking reduction scores, with an intent-to-treat approach. Results: MCII increased smoking reduction compared to the control strategy at high, but not low, levels of cigarette dependence. Conclusion: We found preliminary evidence consistent with MCII, delivered as a brief online intervention, as an effective smoking reduction strategy for highly dependent cigarette smokers. Further research is needed on MCII as a smoking behaviour change intervention.",2020,"We found preliminary evidence consistent with MCII, delivered as a brief online intervention, as an effective smoking reduction strategy for highly dependent cigarette smokers.",[],"['MCII', 'brief self-help interventions: MCII ( n \u2009=\u2009172) or a government-promoted control strategy', 'mental contrasting with implementation intentions (MCII']","['cigarette dependence using the Cigarette Dependence Scale (CDS-5', 'reducing or quitting smoking', 'MCII increased smoking reduction']",[],"[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0187298,"We found preliminary evidence consistent with MCII, delivered as a brief online intervention, as an effective smoking reduction strategy for highly dependent cigarette smokers.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Mutter', 'Affiliation': 'Department of Psychology, New York University, New York, USA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Oettingen', 'Affiliation': 'Department of Psychology, New York University, New York, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Psychology, New York University, New York, USA.'}]",Psychology & health,['10.1080/08870446.2019.1634200'] 206,31264565,A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.,"Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wedge cluster-randomized trial (SW-CRT) design involving four clusters (villages). Selection criteria included village size, proximity to a river, and lack of existing or planned community-level safe water sources. All adults and children were eligible for enrollment. All villages started in the control condition and were sequentially randomized to receive the intervention at 3-month intervals. Our primary outcome was 7-day-period prevalence of self- or caregiver-reported diarrhea, measured at 3-month intervals (five time points). Analysis was by intention to treat. Because blinding was not possible, we incorporated questions about symptoms unrelated to water consumption to check response validity (negative control symptoms). We measured outcomes in 2,222 households (9,836 participants). We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue. Our study highlights both the difficulties in evaluating the impact of real-world interventions and the potential for an optimized SW-CRT design to address budgetary, funding, and logistical constraints inherent in such evaluations.",2020,"We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue.","['rural Indian villages', 'Health in Rural India', '2,222 households (9,836 participants', 'All adults and children were eligible for enrollment']","['Riverbank Filtration Intervention', 'unfiltered river water (improved access alone and control condition', 'riverbank filtration-treated water to newly installed water storage tanks']","['diarrhea post-intervention', '7-day-period prevalence of self- or caregiver-reported diarrhea']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C1720497', 'cui_str': 'River water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0337123', 'cui_str': 'Storage tank, device (physical object)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",9836.0,0.195914,"We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue.","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGuinness', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Boving', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Fraddry', 'Initials': 'F', 'LastName': ""D'Souza"", 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Chetan A', 'Initials': 'CA', 'LastName': 'Gaonkar', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Giriyan', 'Affiliation': 'The Energy and Resources Institute (TERI), Goa, India.'}, {'ForeName': 'S Fiona', 'Initials': 'SF', 'LastName': 'Barker', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sinclair', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leder', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0260'] 207,31933461,Barriers and Enablers to Intervention Uptake and Health Reporting in a Water Intervention Trial in Rural India: A Qualitative Explanatory Study.,"Consumption of unsafe drinking water contributes to the global disease burden, necessitating identification and implementation of effective, acceptable, and sustainable water interventions in resource-limited settings. In a quantitative stepped-wedge cluster randomized trial of a community-based water intervention in rural India, we identified low rates of intervention uptake and reported diarrhea. To better understand and explain these findings, we performed a qualitative study examining barriers and enablers to intervention uptake and health reporting using the COM-B model, where capabilities, opportunities, and motivators interact to generate behavior. We conducted 20 focus groups and one semi-structured interview with participants and four focus groups with data collectors. Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change. Enablers included knowledge of water-related health risks, proximity to tanks, and social opportunity. Barriers to health reporting included variability in interpretation of illness, suspicion regarding the consequences of reporting disease, weariness with repeated questions, and perceived inaction on health data already provided; low survey implementation fidelity was also important. Enablers included surveyor initiatives to encourage reporting and a sense of social responsibility. This qualitative explanatory study allowed better understanding of our quantitative results. It also identified obstacles and facilitators to implementing and evaluating community water interventions, providing insight on how to achieve better intervention uptake and health reporting in future studies.",2020,"Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change.",['Rural India'],['community-based water intervention'],"['knowledge of water-related health risks, proximity to tanks, and social opportunity']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}]",,0.0316373,"Multifactorial barriers to intervention uptake included distorted perceptions of water-related health effects, implementation issues that reduced treated water availability; convenience of, and preference for, alternative drinking water sources; delivery of water to plastic storage tanks (perceived as affecting water quality and taste); and resistance to change.","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGuinness', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Darshini', 'Initials': 'D', 'LastName': 'Ayton', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Giriyan', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Chetan A', 'Initials': 'CA', 'LastName': 'Gaonkar', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Ramkrishna', 'Initials': 'R', 'LastName': 'Vhaval', 'Affiliation': 'The Energy and Resources Institute (TERI), Panaji, India.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leder', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0486'] 208,30996338,"Visual Function Questionnaire as an outcome measure for homonymous hemianopia: subscales and supplementary questions, analysis from the VISION trial.","BACKGROUND We conduct supplementary analyses of the NEI VFQ-25 data to evaluate where changes occurred within subscales of the NEI VFQ-25 leading to change in the composite scores between the three treatment arms, and evaluate the NEI VFQ-25 with and without the Neuro 10 supplement. METHODS A prospective, multicentre, parallel, single-blind, three-arm RCT of fourteen UK acute stroke units was conducted. Stroke survivors with homonymous hemianopia were recruited. Interventions included: Fresnel prisms for minimum 2 h, 5 days/week over 6-weeks (Arm a), Visual search training for minimum 30 min, 5 days/week over 6-weeks (Arm b) and standard care-information only (Arm c). Primary and secondary outcomes (including NEI VFQ-25 data) were measured at baseline, 6, 12 and 26 weeks after randomisation. RESULTS Eighty seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years). At 26 weeks, outcomes for 24, 24 and 22 patients, respectively, were compared to baseline. NEI VFQ-25 (with and without Neuro 10) responses improved from baseline to 26 weeks with visual search training compared to Fresnel prisms and standard care. In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'. CONCLUSIONS Composite scores differed systematically for the NEI VFQ-25 (Neuro 10) versus NEI VFQ-25 at all time points. For subscale scores, descriptive statistics suggest clinically relevant improvement in distance activities and vision-specific dependency subscales for NEI VFQ-25 scores in the visual search treatment arm. TRIAL REGISTRATION Current Controlled Trials ISRCTN05956042.",2019,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'. ","['Stroke survivors with homonymous hemianopia', 'fourteen UK acute stroke units', 'seven patients were recruited (69% male; mean age (SD) equal to 69 (12) years', 'Eighty']","['visual search training', 'Visual search training', 'NEI VFQ-25']","[""colour vision' and 'ocular pain"", 'Visual Function Questionnaire', 'distance activities and vision-specific dependency subscales for NEI VFQ-25 scores', 'NEI VFQ-25 data']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0271202', 'cui_str': 'Hemianopsia, Homonymous'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}]","[{'cui': 'C0086032', 'cui_str': 'Daylight Vision'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",87.0,0.249442,"In subscale analysis, the most impacted across all treatment arms was 'driving' whilst the least impacted were 'colour vision' and 'ocular pain'. ","[{'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Rowe', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK. rowef@liverpool.ac.uk.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Hepworth', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Naomi E A', 'Initials': 'NEA', 'LastName': 'Rainford', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bedson', 'Affiliation': 'Clinical Trials Research Unit, University of Liverpool, Liverpool, L69 3GL, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': 'Department of Orthoptics, Salford Royal NHS Foundation Trust, Manchester, M6 8HD, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollock', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, G4 0BA, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Shipman', 'Affiliation': 'Department of Orthoptics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dodridge', 'Affiliation': 'Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Stevie', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Eye Clinic Support Service, Royal National Institute of Blind People, Birmingham, B29 6NA, UK.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Noonan', 'Affiliation': 'Department of Ophthalmology, Aintree University Hospital NHS Foundation Trust, Liverpool, L9 7AL, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': ""Division of Health and Social Care, King's College, London, WC2B 5RL, UK.""}]","Eye (London, England)",['10.1038/s41433-019-0441-z'] 209,31303281,"Effects of Food and Calcium Carbonate on the Pharmacokinetics of Lusutrombopag, a Novel Thrombopoietin Receptor Agonist.","PURPOSE Lusutrombopag is a novel, orally active thrombopoietin receptor agonist. This report describes 3 studies aimed at assessing the effects of food and calcium carbonate on the pharmacokinetic parameters of lusutrombopag in healthy subjects. METHODS Three single-dose, open-label crossover studies were conducted. In study 1, eighteen healthy subjects were administered a single 2-mg dose of lusutrombopag as a single tablet in the fasted or fed state or as a 2-mg solution in the fasted state. In study 2, fifteen healthy subjects were administered a single 0.75-mg dose of lusutrombopag as three 0.25-mg tablets in the fasted or fed state, or in the fasted state with coadministration of 4000-mg calcium carbonate. In study 3, fifteen healthy subjects were administered 4-mg lusutrombopag as a single tablet in the fasted or fed state. Pharmacokinetic parameters were estimated from plasma lusutrombopag concentrations. FINDINGS Mean fed versus fasted state ratios (90% CIs) of C max and AUC 0-∞ , respectively, were: 0.904 (0.864-0.945) and 0.920 (0.886-0.956) (study 1); 0.972 (0.864-1.09) and 1.02 (0.945-1.11) (study 2); and 0.917 (0.842-0.999) and 0.908 (0.855-0.964) (study 3). The respective ratios for calcium carbonate versus no calcium carbonate (fasted state) were 1.08 (0.959-1.21) and 0.989 (0.913-1.07) (study 2). Lusutrombopag exposure remained unaffected, except for a slight decrease in exposure with food. Lusutrombopag exposure did not change with the coadministration of calcium carbonate. These findings suggest that there was no clinically significant effect of food or calcium carbonate on the bioavailability of lusutrombopag. Each treatment regimen was well tolerated. IMPLICATIONS According to the present findings, no specific restrictions are required for lusutrombopag administration with regard to meals (including those with dairy products), mineral supplements, or coadministration of antacids. CLINICAL TRIAL REGISTRATION JapicCTI-No.: JapicCTI-194690, JapicCTI-194689. ClinicalTrials.gov identifier: NCT03897413.",2019,Lusutrombopag exposure did not change with the coadministration of calcium carbonate.,"['fifteen healthy subjects', 'healthy subjects', 'eighteen healthy subjects']","['4000-mg calcium carbonate', 'calcium carbonate versus no calcium carbonate', '41:XXX-XXX', 'calcium carbonate', 'food and calcium carbonate']","['tolerated', 'bioavailability of lusutrombopag']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}]",18.0,0.0292092,Lusutrombopag exposure did not change with the coadministration of calcium carbonate.,"[{'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Katsube', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co, Ltd, Osaka, Japan. Electronic address: takayuki.katsube@shionogi.co.jp.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Wajima', 'Affiliation': 'Clinical Pharmacology & Pharmacokinetics, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Clinical Research Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.06.004'] 210,31403339,Using mental contrasting with implementation intentions to reduce bedtime procrastination: two randomised trials.,"Objective : The importance of getting a good night sleep is critical, yet for many this remains elusive. Bedtime procrastination-the notion that people delay going to bed for no legitimate reason-is one area that has received little attention, despite its associations with worse sleep outcomes. In the present research, we investigated how to effectively self-regulate bedtime procrastination. Design : In two studies (N1 = 383, N2 = 221), undergraduate students participated either in an online self-regulation exercise called mental contrasting with implementation intentions (MCII) or a motivationally-relevant control exercise (Study 1) or a sleep hygiene control group (Study 2). We then assessed outcomes three weeks (Study 1) or one week (Study 2) later. Main Outcome Measures : We assessed commitment to reduce bedtime procrastination and self-reported bedtime procrastination using two different measures. Results : We found that MCII (compared to control) increased commitment to reduce bedtime procrastination. In both studies this corresponded to a reduction in the average minutes of bedtime procrastination per night. Conclusion : MCII is a simple and cost-effective self-regulation tool for reducing bedtime procrastination. Future research should seek to reveal the mechanisms that undergird bedtime procrastination, as well as understand the present findings in other populations and contexts.",2020,We found that MCII (compared to control) increased commitment to reduce bedtime procrastination.,"['two studies (N1\u2009=\u2009383, N2\u2009=\u2009221), undergraduate students participated either in an']","['MCII', 'online self-regulation exercise called mental contrasting with implementation intentions (MCII) or a motivationally-relevant control exercise (Study 1) or a sleep hygiene control']",['bedtime procrastination and self-reported bedtime procrastination using two different measures'],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0506332,We found that MCII (compared to control) increased commitment to reduce bedtime procrastination.,"[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Valshtein', 'Affiliation': 'Department of Psychology, New York University, New York, NY, USA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Oettingen', 'Affiliation': 'Department of Psychology, New York University, New York, NY, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Psychology, New York University, New York, NY, USA.'}]",Psychology & health,['10.1080/08870446.2019.1652753'] 211,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND Postnatal growth restriction (PNGR) in premature infants increases risk of pulmonary hypertension (PH). In a rodent model, PNGR causes PH, while combining PNGR and hyperoxia increases PH severity. We hypothesized that PNGR causes intestinal dysbiosis and that treatment with a probiotic attenuates PNGR-associated PH. METHOD Pups were randomized at birth to room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR (17 pups/dam), and to probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline. After 14 days, PH was assessed by echocardiography and right ventricular hypertrophy (RVH) was assessed by Fulton's index (right ventricular weight/left ventricle + septal weight). The small bowel and cecum were analyzed by high-throughput 16S ribosomal RNA gene sequencing. RESULTS PNGR with or without hyperoxia (but not hyperoxia alone) altered the microbiota of the distal small bowel and cecum. Treatment with DSM 17938 attenuated PH and RVH in pups with PNGR, but not hyperoxia alone. DSM 17938 treatment decreased α-diversity. The intestinal microbiota differed based on oxygen exposure, litter size, and probiotic treatment. CONCLUSION PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2'] 212,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life. METHODS This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2 per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min. RESULTS Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation. CONCLUSIONS Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2 and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x'] 213,31680625,Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial.,"BACKGROUND The ""Promoting Resilience in Stress Management"" intervention is a skills-based, early palliative care intervention with demonstrated efficacy in adolescents and young adults with cancer. AIM Utilizing data from a randomized clinical trial of Promoting Resilience in Stress Management versus Usual Care, we examined whether response to Promoting Resilience in Stress Management differed across key sociodemographic characteristics. DESIGN Adolescents and young adults with cancer completed patient-reported outcome measures of resilience, hope, benefit-finding, quality of life, and distress at enrollment and 6 months. Participants were stratified by sex, age, race, and neighborhood socioeconomic disadvantage based on home address (Area Deprivation Index scores with 8-10 = most disadvantaged). Differences in the magnitude of effect sizes between stratification subgroups were noted using a conservative cutoff of d  > 0.5. SETTING/PARTICIPANTS Participants were 12 to 25 years old, English-speaking, and receiving cancer care at Seattle Children's Hospital. RESULTS In total, 92 adolescents and young adults (48 Promoting Resilience in Stress Management, 44 Usual Care) completed baseline measures. They were 43% female, 73% 12 to 17 years old, 64% White, and 24% most disadvantaged. Effect sizes stratified by sex, age, and race were in an expected positive direction and of similar magnitude for the majority of outcomes with some exceptions in magnitude of treatment effect. Those who lived in less disadvantaged neighborhoods benefited more from Promoting Resilience in Stress Management, and those living in most disadvantaged neighborhoods benefited less. CONCLUSION The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race. It may not be as helpful for adolescents and young adults living in disadvantaged neighborhoods. Future studies must confirm its generalizability and integrate opportunities for improvement by targeting individual needs.",2020,"The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race.","['They were 43% female, 73% 12 to 17\u2009years old, 64% White, and 24% most disadvantaged', 'Participants were stratified by sex, age, race, and neighborhood socioeconomic disadvantage based on home address (Area Deprivation Index scores with 8-10\u2009=\u2009most disadvantaged', '92 adolescents and young adults (48 Promoting Resilience in Stress Management, 44 Usual Care) completed baseline measures', ""Participants were 12 to 25\u2009years old, English-speaking, and receiving cancer care at Seattle Children's Hospital"", 'adolescents and young adults with cancer', 'Adolescents and young adults with cancer completed patient', 'adolescents and young adults living in disadvantaged neighborhoods']",[],"['resilience, hope, benefit-finding, quality of life, and distress']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205393', 'cui_str': 'Most (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",92.0,0.144515,"The ""Promoting Resilience in Stress Management"" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race.","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Bona', 'Affiliation': 'Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': 'Division of Child Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Center for Clinical and Translational Research, Palliative Care and Resilience Research Center, Seattle Children's Research Institute, Seattle, WA, USA.""}]",Palliative medicine,['10.1177/0269216319886215'] 214,31345559,"Efficacy and Tolerability of Sufentanil, Dexmedetomidine, or Ketamine Added to Propofol-based Sedation for Gastrointestinal Endoscopy in Elderly Patients: A Prospective, Randomized, Controlled Trial.","PURPOSE To investigate the optimal agent combined with propofol for sedation in elderly patients undergoing gastrointestinal endoscopy. METHODS A total of 120 elderly patients scheduled for gastrointestinal endoscopy under propofol-based sedation were randomly allocated to receive propofol + saline (control group), propofol + sufentanil 0.1 μg/kg, propofol + dexmedetomidine 0.4 μg/kg, or propofol + ketamine 0.4 mg/kg. Mean arterial pressure, heart rate, pulse oximetry, pressure of end-tidal carbon dioxide, respiratory rate, and Ramsay sedation scale score were recorded. Induction time, procedure time, recovery time, propofol dose, and adverse events were also recorded. FINDINGS During the sedation procedure, the AUC of HR was lowest in the propofol + dexmedetomidine group (all, P < 0.05), and the AUC of pulse oximetry was significantly higher in the propofol + dexmedetomidine and propofol + ketamine groups compared to the other 2 groups (both, P < 0.05). The propofol + dexmedetomidine group had the highest prevalences of hypotension and bradycardia, and the control group experienced the largest number of hypoxia episodes (all, P < 0.05). The control group consumed the highest dose of propofol, while the propofol + ketamine group needed the lowest dose (all, P < 0.05). IMPLICATIONS The combination of propofol + ketamine 0.4 mg/kg maintained hemodynamic and respiratory stability, as evidenced by less hypotension, bradycardia, and hypoxia events, in elderly patients undergoing gastrointestinal endoscopy. China clinical trial registration (chictr.org.cn) ID: ChiCTR-INR-17013710.",2019,"The combination of propofol + ketamine 0.4 mg/kg maintained hemodynamic and respiratory stability, as evidenced by less hypotension, bradycardia, and hypoxia events, in elderly patients undergoing gastrointestinal endoscopy.","['120 elderly patients scheduled for gastrointestinal endoscopy under propofol-based sedation', 'elderly patients undergoing gastrointestinal endoscopy', 'Elderly Patients']","['propofol\xa0+ ketamine', 'Propofol-Based Sedation', 'propofol\xa0+\xa0ketamine', 'propofol', 'propofol\xa0+\xa0saline (control group), propofol\xa0+\xa0sufentanil 0.1\xa0μg/kg, propofol\xa0+\xa0dexmedetomidine 0.4\xa0μg/kg, or propofol\xa0+\xa0ketamine 0.4\xa0mg/kg', 'Sufentanil, Dexmedetomidine, or Ketamine', 'dexmedetomidine', 'propofol\xa0+\xa0dexmedetomidine']","['hypotension and bradycardia', 'AUC of pulse oximetry', 'hypoxia episodes', 'hypotension, bradycardia, and hypoxia events', 'AUC\xa0of HR', 'Efficacy and Tolerability', 'Induction time, procedure time, recovery time, propofol dose, and adverse events', 'Mean arterial pressure, heart rate, pulse oximetry, pressure of end-tidal carbon dioxide, respiratory rate, and Ramsay sedation scale score']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0079278', 'cui_str': 'Endoscopy, Gastrointestinal'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.0287033,"The combination of propofol + ketamine 0.4 mg/kg maintained hemodynamic and respiratory stability, as evidenced by less hypotension, bradycardia, and hypoxia events, in elderly patients undergoing gastrointestinal endoscopy.","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Junpeng', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sha', 'Affiliation': 'Department of Anesthesiology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Zhicong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Shenzhen Second People's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Chaoyang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Shenzhen Sixth People's Hospital (Nanshan Hospital), Huazhong University of Science and Technology Union Shenzhen Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': 'Youtan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China. Electronic address: youtanliuhao@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.06.011'] 215,31447131,Serious Adverse Effects of Extended-release Niacin/Laropiprant: Results From the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) Trial.,"PURPOSE The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial of patients at high risk of vascular disease found that adding extended-release niacin-laropiprant to intensive statin-based LDL-lowering therapy had no benefit on cardiovascular outcomes. However, the trial also identified previously unrecognized serious adverse effects (including new-onset diabetes, bleeding, and infection). Our objective was to explore the safety profile of niacin-laropiprant and examine whether any patients were at lower (or higher) risk of its adverse effects. METHODS HPS2-THRIVE was a randomized, double-blind trial of niacin-laropiprant (2000/40 mg/d) versus placebo among 25,673 patients at high risk of vascular disease. Information on all serious adverse events was collected during a median of 3.9 years of study treatment. Effects of niacin-laropiprant on new-onset diabetes, disturbances of diabetes control, bleeding, infection, and gastrointestinal upset were estimated by (1) time after randomization, (2) severity, (3) baseline characteristics, (4) baseline risk of the adverse event of interest, and (5) risk of major vascular event. FINDINGS The hazard ratio (HR) for new-onset diabetes with niacin/laropiprant was 1.32 (95% CI, 1.16-1.51; P < .001), which corresponded to an absolute excess of 4 people (95% CI, 2-6) developing diabetes per 1000 person-years in the study population as a whole. Among the 8299 participants with diabetes at baseline, the HR for serious disturbances in diabetes control was 1.56 (95% CI, 1.35-1.80), corresponding to an absolute excess of 12 (95% CI, 8-16) per 1000 person-years. The HR was 1.38 (95% CI, 1.17-1.63; P < .001) for serious bleeding, corresponding to an absolute excess of 2 (95% CI, 1-3) per 1000 person-years and 1.22 (95% CI, 1.11-1.34; P < .001) for serious infection, corresponding to an absolute excess of 4 (95% CI, 2-6) per 1000 person-years. The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased. The absolute excesses of each of these adverse effects were similar regardless of the baseline risk of the outcome. IMPLICATIONS Practitioners or patients considering the use of niacin (in addition to, or instead of, a statin) despite the lack of evidence of cardiovascular benefits (at least when added to effective statin therapy) should take account of the significant risks of these serious adverse effects when making such decisions. ClinicalTrials.gov identifier: NCT00461630.",2019,"The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased.","['8299 participants with diabetes', '25,673 patients at high risk of vascular disease', 'patients at high risk of vascular disease found that adding extended-release niacin-laropiprant to intensive statin-based LDL-lowering therapy had no benefit on cardiovascular outcomes']","['niacin', 'placebo', 'Extended-Release Niacin/Laropiprant', 'niacin-laropiprant']","['serious adverse events', 'risks of nonfatal and fatal events', 'serious bleeding', 'hazard ratio (HR', 'new-onset diabetes, disturbances of diabetes control, bleeding, infection, and gastrointestinal upset were estimated by (1) time after randomization, (2) severity, (3) baseline characteristics, (4) baseline risk of the adverse event of interest, and (5) risk of major vascular event']","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1956497'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1956497'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.379437,"The excess risks of these serious adverse events were larger in the first year after starting niacin-laropiprant therapy than in later years (except for the excess of infection, which did not appear to attenuate with time), and the risks of nonfatal and fatal events were similarly increased.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom. Electronic address: richard.haynes@ndph.ox.ac.uk.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Valdes-Marquez', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jemma C', 'Initials': 'JC', 'LastName': 'Hopewell', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Centre for Cardiovascular Disease, Beijing, China.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2019.06.012'] 216,31378318,"Effect of Cefiderocol, a Siderophore Cephalosporin, on QT/QTc Interval in Healthy Adult Subjects.","PURPOSE Cefiderocol is a novel siderophore cephalosporin with potent activity against gram-negative bacteria, including multidrug-resistant strains. This Phase I study was conducted to assess the tolerability of single-ascending doses of cefiderocol (part 1) and the effect of cefiderocol on cardiac repolarization, assessed using the electrocardiographic corrected QT interval (QTcF) and other ECG parameters (part 2), in healthy adult subjects. METHODS Part 1 was a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy adult male and female subjects. Part 2 was a 4-period crossover study in which subjects received a single 2-g dose of cefiderocol (therapeutic dose), a single 4-g dose of cefiderocol (supratherapeutic dose), or saline (placebo), each infused over 3 hours, and a single oral 400-mg dose of moxifloxacin. In each treatment period, continuous cardiac monitoring was used to assess the effects of cefiderocol on ECG parameters. The QT interval corrected using the Fridericia formula (QTcF) was the primary ECG parameter; the time-matched placebo- and baseline-adjusted (dd)-QTcF interval was the primary end point. The plasma pharmacokinetic properties of cefiderocol were calculated on the basis of concentration-time profiles in all evaluable subjects. FINDINGS All point estimates for the ddQTcF interval were <5 ms and the upper bound of the 90% CIs were <10 ms at each timepoint after the initiation of the cefiderocol 3-hour infusion. Concentration-effect modeling showed a slightly negative slope and predicted modestly negative values of the ddQTcF interval at the C max of cefiderocol. Both doses of cefiderocol were well tolerated. All adverse events were mild in severity, with no deaths or serious adverse events reported. IMPLICATIONS Overall, therapeutic and supratherapeutic doses of cefiderocol had no apparent clinically significant effect on the QTcF.",2019,"Overall, therapeutic and supratherapeutic doses of cefiderocol had no apparent clinically significant effect on the QTcF.","['healthy adult subjects', 'healthy adult male and female subjects', 'Healthy Adult Subjects']","['placebo', 'cefiderocol', 'cefiderocol (therapeutic dose), a single 4-g dose of cefiderocol (supratherapeutic dose), or saline (placebo', 'moxifloxacin', 'Cefiderocol, a Siderophore Cephalosporin']","['tolerability', 'ddQTcF interval', 'electrocardiographic corrected QT interval (QTcF', 'QTcF', 'tolerated', 'QT interval', 'plasma pharmacokinetic properties of cefiderocol']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4548369', 'cui_str': 'cefiderocol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0142281', 'cui_str': 'Siderochromes'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C4548369', 'cui_str': 'cefiderocol'}]",,0.171238,"Overall, therapeutic and supratherapeutic doses of cefiderocol had no apparent clinically significant effect on the QTcF.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanabria', 'Affiliation': 'Spaulding Clinical Research, LLC, West Bend, WI, USA. Electronic address: carlos.sanabria@spauldingclinical.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Migoya', 'Affiliation': 'Shionogi Inc, Florham Park, NJ, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Mason', 'Affiliation': 'Mason Cardiac Safety Consulting, Reno, NV, USA.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Stanworth', 'Affiliation': 'Spaulding Clinical Research, LLC, West Bend, WI, USA.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Katsube', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Machida', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Yukitoshi', 'Initials': 'Y', 'LastName': 'Narukawa', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Tsutae', 'Initials': 'T', 'LastName': 'Den Nagata', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.006'] 217,32348282,Correction: A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/14914.].,2020,[This corrects the article DOI: 10.2196/14914.].,['Patients With Type 2 Diabetes in Asia'],['Smartphone App'],['Medication Adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0584139,[This corrects the article DOI: 10.2196/14914.].,"[{'ForeName': 'Zhilian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Eberta', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sloot', 'Affiliation': 'Complexity Institute, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Bernhard Otto', 'Initials': 'BO', 'LastName': 'Boehm', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/18411'] 218,30932719,"Assessment of potentially abuse-related events in two phase 3 studies of NKTR-181, a novel opioid analgesic, using the MADDERS® system (Misuse, Abuse, and Diversion Drug Event Reporting System).","Objective: To prospectively evaluate the abuse potential of NKTR-181, a novel opioid analgesic, in two phase 3 clinical trials using a newly developed reporting system: the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®). Methods: SUMMIT-07 was an enriched enrollment randomized withdrawal study that examined the safety and efficacy of NKTR-181 across 12 weeks in opioid-naïve subjects with chronic low back pain. SUMMIT-LTS was a 52 week open-label study in opioid-naïve and experienced subjects with chronic low back pain or noncancer pain rolled over from SUMMIT-07 or enrolled de novo . System evaluations were triggered by adverse events of interest and drug accountability discrepancies signaling potentially abuse-related events. Each event was assigned a primary classification and supplementary classification(s) by investigators and by a blinded, independent committee of substance abuse experts (adjudicators). At the final study visit, investigators administered a survey to subjects to identify overlooked events of interest. Results: Seventy-nine (6.6%) of 1189 subjects were associated with 86 events in SUMMIT-07 and 51 (8.0%) of 638 subjects were associated with 59 events in SUMMIT-LTS. Most events were attributed to ""Withdrawal"" and, primarily in SUMMIT-07, ""Therapeutic Error"" (unintentional overuse) or ""Misuse"" (intentional overuse for a therapeutic purpose) of study medication. Adjudicators identified five possible ""Abuse"" events (three NKTR-181, two placebo) in SUMMIT-07 and four possible ""Abuse"" events (all NKTR-181) in SUMMIT-LTS. Conclusions: The MADDERS® system discerns potentially abuse-related events and identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in phase 3 trials.",2019,"The MADDERS® system discerns potentially abuse-related events and identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in phase 3 trials.","['naïve subjects with chronic low back pain', 'subjects with chronic low back pain or noncancer pain rolled over from SUMMIT-07 or enrolled de novo']","['opioid', 'NKTR-181']","['safety and efficacy', 'Abuse"" events']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543436', 'cui_str': 'Does roll over (finding)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C4547855', 'cui_str': 'NKTR-181'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1189.0,0.0159291,"The MADDERS® system discerns potentially abuse-related events and identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in phase 3 trials.","[{'ForeName': 'Ryan K', 'Initials': 'RK', 'LastName': 'Lanier', 'Affiliation': 'Analgesic Solutions, Wayland, MA, USA.'}, {'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': 'Pain Management Center, Englewood Hospital and Medical Center, Englewood, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Elder', 'Affiliation': 'Analgesic Solutions, Wayland, MA, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Erpelding', 'Affiliation': 'Analgesic Solutions, Wayland, MA, USA.'}, {'ForeName': 'Roi', 'Initials': 'R', 'LastName': 'Treister', 'Affiliation': 'Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, AZ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Doberstein', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Carlo J', 'Initials': 'CJ', 'LastName': 'Di Fonzo', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': 'Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Nathaniel P', 'Initials': 'NP', 'LastName': 'Katz', 'Affiliation': 'Analgesic Solutions, Wayland, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1594744'] 219,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy. METHODS Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed. RESULTS From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]). CONCLUSIONS Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively. ","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively. ","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083'] 220,32318777,Cyclosporine A prevents cardiac arrest-induced acute respiratory failure: a post-hoc analysis of the CYRUS trial.,,2020,,[],['Cyclosporine'],['cardiac arrest-induced acute respiratory failure'],[],"[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]",,0.195655,,"[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Kreitmann', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': 'Faculté de médecine Lyon Est, Université de Lyon, Université Claude Bernard Lyon 1, 69373, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Cour', 'Affiliation': ""Service de Médecine Intensive - Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, 5, place d'Arsonval, 69437, Lyon Cedex 03, France. martin.cour@chu-lyon.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06043-0'] 221,31943506,"Predictive Impact of Mucinous Tumors on the Clinical Outcome in Patients with Poorly Differentiated, Stage II Colon Cancer: A TOSCA Subgroup Analysis.","BACKGROUND Although American Society of Clinical Oncology and European Society for Medical Oncology guidelines have identified the negative prognostic factors that clinicians have to consider when treating their patients with stage II colon cancer (CC), the role of histological subtype is controversial. SUBJECTS, MATERIALS, AND METHODS The randomized, multicenter, phase III TOSCA trial compared 3 versus 6 months of fluoropyrimidine-oxaliplatin adjuvant chemotherapy in 3,759 patients with high-risk stage II or stage III CC. The objective of this substudy was to evaluate the influence of histological subtypes on the impact of the treatment duration of adjuvant chemotherapy in terms of relapse-free survival (RFS) and overall survival (OS) in 85 mucinous adenocarcinoma (MUC) and 389 nonmucinous adenocarcinoma (NMUC) patients with high-risk stage II, grade 3 CC. RESULTS A significant interaction between treatment duration and histology was observed in both RFS (p = .027) and OS (p = .017). In the subgroup of patients with MUC, worse RFS (adjusted hazard ratio [HR], 3.95; 95% confidence interval [CI], 1.03-15.17; p = .045) and OS (HR, 9.56; 95% CI, 1.14-79.98; p = .037) were detected for patients treated in the 3-month arm. No statistically significant differences were found in the subgroup of patients with NMUC. CONCLUSION Patients with MUC, grade 3, stage II CC require special attention and may need 6 months of oxaliplatin-based chemotherapy. Larger studies are required to assess the combined use of histology and other prognostic/predictive factors to define the administration of chemotherapy in patients with stage II CC and to improve their prognosis. IMPLICATIONS FOR PRACTICE Although ASCO and ESMO guidelines define the prognostic factors for patients with stage II colon cancer to establish the use of adjuvant chemotherapy, the influence of histological subtypes is controversial in this population. This study underscores that patients with grade 3 mucinous adenocarcinomas may need adjuvant chemotherapy with oxaliplatin and fluoropyrimidines for a duration of 6 months rather than 3 months.",2020,A significant interaction between treatment duration and histology was observed in both RFS (p = .027) and OS (p = .017).,"['85 mucinous adenocarcinoma (MUC) and 389 nonmucinous adenocarcinoma (NMUC) patients with high-risk stage II, grade 3 CC', '3,759 patients with high-risk stage II or stage III CC', 'patients with stage II CC', 'patients with stage II colon cancer', 'patients with stage II colon cancer (CC', 'Patients with Poorly Differentiated, Stage II Colon Cancer', 'patients with grade 3 mucinous adenocarcinomas']","['oxaliplatin-based chemotherapy', 'fluoropyrimidine-oxaliplatin adjuvant chemotherapy', 'oxaliplatin and fluoropyrimidines', 'adjuvant chemotherapy']","['RFS', 'relapse-free survival (RFS) and overall survival (OS']","[{'cui': 'C0007130', 'cui_str': 'Carcinoma, Mucinous'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated (qualifier value)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",3759.0,0.141833,A significant interaction between treatment duration and histology was observed in both RFS (p = .027) and OS (p = .017).,"[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'U.O. Oncologia Medica, Ospedale S. Carlo, Potenza, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Methodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'U.O. Oncologia Medica, Azienda USL 1 di Massa e Carrara, Carrara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'U.O. Oncologia Medica 1, IRCCS Istituto Oncologico Veneto, Padova, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'U.O. Oncologia Medica, Azienda USL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Maria Giulia', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Gastrointestinal Medical Oncology Unit and Neuroendocrine Tumors, IRCCS Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Mattioli', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliera Marche Nord, Pesaro/Fano, Italy.'}, {'ForeName': 'Giovanni Gerardo', 'Initials': 'GG', 'LastName': 'Cardellino', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliera Universitaria S. Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'U.O. Oncologia Medica, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'U.O. Oncologia Medica, Fondazione IRCCS INT, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamberi', 'Affiliation': 'U.O. Oncologia Medica, Ospedale degli Infermi, Faenza, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""U.O. Oncologia Medica, Ospedale Sant'Andrea, Università Sapienza, Roma e IRCCS Istituto Dermopatico dell'Immacolata, Rome, Italy.""}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corsi', 'Affiliation': 'U.O. Oncologia Medica, Ospedale S. Giovanni Calibita Fatebenefratelli, Rome, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Bochicchio', 'Affiliation': 'U.O. Oncologia Medica, Ospedale Oncologico Regionale CROB, Rionero in Vulture, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Artioli', 'Affiliation': 'U.O. Oncologia Medica, Ospedale B. Ramazzini, Carpi, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Methodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Methodology for Clinical Research Laboratory, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Bilancia', 'Affiliation': 'U.O. Oncologia Medica, Ospedale S. Carlo, Potenza, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Bregni', 'Affiliation': 'U.O. Oncologia Medica, IRCCS San Martino-IST, Genova, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0736'] 222,32320639,Prevalence of Pre-Existing Hearing Loss Among Patients With Drug-Resistant Tuberculosis in South Africa.,"Purpose Hearing loss, resulting from aminoglycoside ototoxicity, is common among patients with drug-resistant tuberculosis (DR-TB). Those with pre-existing hearing loss are at particular risk of clinically important hearing loss with aminoglycoside-containing treatment than those with normal hearing at baseline. This study aimed to identify factors associated with pre-existing hearing loss among patients being treated for DR-TB in South Africa. Method Cross-sectional analysis nested within a cluster-randomized trial data across 10 South African TB hospitals. Patients ≥ 13 years old received clinical and audiological evaluations before DR-TB treatment initiation. Results Of 936 patients, average age was 35 years. One hundred forty-two (15%) reported pre-existing auditory symptoms. Of 482 patients tested by audiometry, 290 (60%) had pre-existing hearing loss. The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]). Having HIV with cluster of differentiation 4 cell count < 200 cells/mm 3 and malnutrition were risk factors but did not reach statistical significance in adjusted analyses. Conclusion Pre-existing hearing loss is common among patients presenting for DR-TB treatment in South Africa, and those older than the age of 50 years or who had prior second-line TB treatment history were at highest risk.",2020,"The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]).","['patients presenting for DR-TB treatment in South Africa, and those older than the age of 50 years or who had prior second-line TB treatment history were at highest risk', 'Patients With Drug-Resistant Tuberculosis in South Africa', '482 patients tested by audiometry, 290 (60%) had pre-existing hearing loss', 'Patients ≥ 13 years old received clinical and audiological evaluations before DR-TB treatment initiation', 'patients being treated for DR-TB in South Africa', '936 patients', '10 South African TB hospitals', 'patients with drug-resistant tuberculosis (DR-TB']",['Pre-Existing Hearing Loss'],"['prevalence of pre-existing hearing loss', 'audiometric hearing loss', 'pre-existing auditory symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206525', 'cui_str': 'Drug resistant tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004286', 'cui_str': 'Audiometric test'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0200297', 'cui_str': 'Audiological evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",936.0,0.114216,"The prevalence of pre-existing hearing loss was highest among patients ≥ 50 years (adjusted prevalence ratio [aPrR] for symptoms 5.53, 95% confidence interval (CI) [3.63, 8.42]; aPrR for audiometric hearing loss 1.63, 95% CI [1.31, 2.03] compared to age 13-18 years) and among those with a prior history of second-line TB treatment (aPrR for symptoms 1.73, 95% CI [1.66, 1.80]; PrR for audiometric hearing loss 1.33, 95% CI [1.03, 1.73]).","[{'ForeName': 'Hyejeong', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Divisions of Clinical Pharmacology and Infectious Disease, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Francis', 'Affiliation': 'Division of Head and Neck Surgery and Communication Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Chakra', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'Hae-Ra', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Farley', 'Affiliation': 'The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}]",American journal of audiology,['10.1044/2020_AJA-19-00103'] 223,32319392,[Clinical Efficacy of Low-Dose Bortezomib-Based Triple Combination Therapy in the Treatment of Elderly Multiple Myeloma].,"OBJECTIVE To investigate the clinical efficacy and safety of low-dose bortezomib-based triple combination therapy in the treatment of elderly multiple myeloma(MM). METHODS Fifty-eight patients with elderly multiple myeloma were selected. And according to the drug rigimen the patients were randomly divided into three groups. Group A: patients received low-dose bortezomib(0.7mg/m 2 ) on day 1, 4, 8 and 11; cyclophosphamide (0.5 g/m 2 ) d 1, d 8; dexamethasone d 1-2,d 4-5, d 8-11, d 11-12. Group B: patients received bortezomib (1.3 mg/m 2 ) on day 1, 4, 8 and 11; cyclophosphamide (0.5 g/m 2 ) d 1, d 8; dexamethasone d 1-2, d 4-5, d 8-11, d 11-12. Group C: patients received bortezomib(0.7 mg/m 2 ) on day 1, 4, 8 and 11; dexamethasone d 1-2, d 4-5, d 8-11, d 11-12. All patients in three groups were treated for 4 circles. The efficacy and response of the three groups were compared. RESULTS The complete remission (CR) rate in the three groups was 31.58%, 38.09% and 27.78%. And the overall response (ORR) rate of the three groups was 68.42%, 66.67% and 55.56%, there was no statistical difference among the three groups (P＞0.05). The Hb level in MM patients with anemia after treatment was higher than the basic value. There were no statistical differences in percapita red blood cell transfusion, the incidence of bone marrow suppression and infection during 4 courses treatment among 3 groups, but the incidence of peripheral neuropathy, gastrointestinal reaction and herper zoster in group A was significantly lower than that in group B and C, moreover there was statistical difference. After the follow-up for 1 year, there was no significant difference in the survival rate among 3 groups. CONCLUSION The efficacy of low dose bortezomib-based triple combination therapy for the patients with elderly multiple mycloma is same efficacy as of standard dose bortezomib-based triple combination therapy, but the incidence of perpheral neuropathy, gastrointestinal reaction and herper zoster is lower, the patients have better torelonce to low dose bortezomib-based triple combination therapy regimen, suggesting that this therapy possesses the efficacy of less adverse reactions and more high safety in treatment of patients with elderly muitipe myelome.",2020,"There were no statistical differences in percapita red blood cell transfusion, the incidence of bone marrow suppression and infection during 4 courses treatment among 3 groups, but the incidence of peripheral neuropathy, gastrointestinal reaction and herper zoster in group A was significantly lower than that in group B and C, moreover there was statistical difference.","['elderly multiple myeloma(MM', 'patients with elderly multiple mycloma', 'Elderly Multiple Myeloma', 'Fifty-eight patients with elderly multiple myeloma were selected', 'patients with elderly muitipe myelome']","['bortezomib(0.7', 'low-dose bortezomib-based\xa0triple combination therapy', 'dexamethasone', 'bortezomib-based triple combination therapy', 'cyclophosphamide', 'Low-Dose Bortezomib-Based\xa0Triple Combination Therapy', 'bortezomib']","['overall response (ORR) rate', 'complete remission (CR) rate', 'survival rate', 'percapita red blood cell transfusion, the incidence of bone marrow suppression and infection', 'peripheral neuropathy, gastrointestinal reaction and herper zoster']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",58.0,0.0117878,"There were no statistical differences in percapita red blood cell transfusion, the incidence of bone marrow suppression and infection during 4 courses treatment among 3 groups, but the incidence of peripheral neuropathy, gastrointestinal reaction and herper zoster in group A was significantly lower than that in group B and C, moreover there was statistical difference.","[{'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Ying-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China,E-mail: yinghuali71@163.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China.'}, {'ForeName': 'Su-Qing', 'Initials': 'SQ', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, Harrison International Peace Hospital, Hengshui 053000, Hebei Province, China,E-mail: yuanyuan0229@163.com.'}]",Zhongguo shi yan xue ye xue za zhi,['10.19746/j.cnki.issn.1009-2137.2020.02.030'] 224,31538372,Differential Posttreatment Outcomes of Methylphenidate for Smoking Cessation for Individuals With ADHD.,"BACKGROUND AND OBJECTIVES In a multisite, randomized study (CTN-0029), a 3-month course of Osmotic-Release Oral System Methylphenidate (OROS-MPH) improved smoking cessation in a group of patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD). This treatment, however, worsened smoking cessation outcome in the group with lower baseline ADHD severity. We want to examine whether this differential treatment effect persisted after OROS-MPH was discontinued. METHODS We conducted a secondary analysis of the 1-month follow-up data from CTN-0029 after the discontinuation of OROS-MPH (N = 134). Nicotine patch was tapered during this month. We tested whether OROS-MPH had an effect on self-reported 7-day abstinence by week, as well as possible treatment by baseline ADHD severity interactions. RESULTS Abstinence diminished overall in time after the end of the treatment. In the high baseline severity group, patients who received OROS-MPH had an advantage in 7-day abstinence at week 15 (40% for OROS-MPH vs 20% for placebo, odds ratio = 2.63, P = .028). In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups. There was also a significant treatment by baseline ADHD severity interaction (P = .03). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE OROS-MPH promotes abstinence beyond the course of treatment for patients with more severe ADHD, while the paradoxical effects in the lower baseline severity group is not persistent after medication discontinuation. Targeting ADHD in smoking cessation as a comorbidity therefore can have broader impact with more precise patient selection. (Am J Addict).",2019,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","['patients with more severe ADHD', 'patients with higher baseline severity in Attention-Deficit/Hyperactivity Disorder (ADHD', 'Individuals With ADHD']","['OROS-MPH', 'Osmotic-Release Oral System Methylphenidate (OROS-MPH', 'Nicotine patch', 'Methylphenidate']","['7-day abstinence', 'baseline ADHD severity interaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.240385,"In the lower severity group (n = 121), no difference was detected (29% for OROS-MPH vs 32% for placebo, P = 1.00) between the two treatment groups.","[{'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Lirio S', 'Initials': 'LS', 'LastName': 'Covey', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Winhusen', 'Affiliation': 'Division of Addiction Sciences, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry, Division on Substance Use Disorders, Columbia University, New York, New York.'}]",The American journal on addictions,['10.1111/ajad.12961'] 225,32291222,"Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel syndrome: a multicentre randomised trial.","QUESTION In people with carpal tunnel syndrome who are waitlisted for surgical consultation, does a therapist-led care pathway involving education, splinting and exercises reduce the need for surgery and improve patient outcomes? DESIGN A multicentre, randomised controlled trial with concealed allocation, blinded assessment and intention-to-treat analysis. PARTICIPANTS One hundred and five people with electrodiagnostically confirmed carpal tunnel syndrome on a waitlist for surgical consultation and recruited from four public hospitals in Australia. INTERVENTIONS The experimental group (n = 52) received a one-off group session of education, splinting, and nerve and tendon gliding exercises. The control group (n = 53) continued on the waitlist without additional care. OUTCOME MEASURES The primary outcome measures were conversion to surgery by 24 weeks, the global rating of change (GROC) scale and patient satisfaction. Secondary outcomes included symptom severity and functional limitation. RESULTS At 24 weeks, conversion to surgery was 59% in the experimental group and 80% in the control group (risk difference -0.21, 95% CI -0.38 to -0.03). More participants in the experimental group identified as improved at 6 weeks (20% vs 4%; risk difference 0.15, 95% CI 0.03 to 0.28) but not at 24 weeks (24% vs 10%; risk difference 0.14, 95% CI -0.01 to 0.29). The intervention was also estimated to be beneficial on some measures of satisfaction, symptom severity and functional limitation. The study's estimates of the benefits came with some uncertainty, which makes it unclear whether the wider population of people awaiting carpal tunnel surgery would consider that the benefits make the intervention worthwhile. No serious adverse effects were reported. CONCLUSIONS A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation. REGISTRATION ACTRN12613001095752.",2020,"A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation. ","['people with carpal tunnel syndrome who are waitlisted for surgical consultation', 'One hundred and five people with electrodiagnostically confirmed carpal tunnel syndrome on a waitlist for surgical consultation and recruited from four public hospitals in Australia']","['one-off group session of education, splinting, and nerve and tendon gliding exercises', 'night splinting and home exercises reduce conversion to surgery', 'waitlist without additional care']","['symptom severity and functional limitation', 'satisfaction, symptom severity and functional limitation', 'conversion to surgery by 24 weeks, the global rating of change (GROC) scale and patient satisfaction', 'serious adverse effects', 'conversion to surgery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556894', 'cui_str': 'Night splinting'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",105.0,0.157446,"A therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement and satisfaction in people who were already on a waitlist for surgical consultation. ","[{'ForeName': 'Karina J', 'Initials': 'KJ', 'LastName': 'Lewis', 'Affiliation': 'Occupational Therapy Department, Gold Coast University Hospital, Gold Coast, Australia; School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Coppieters', 'Affiliation': 'The Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Brisbane and Gold Coast, Australia; Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Allied Health Department, Queen Elizabeth II Jubilee Hospital, Brisbane, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hughes', 'Affiliation': 'Gold Coast University Hospital, Southport, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia.'}, {'ForeName': 'Annina B', 'Initials': 'AB', 'LastName': 'Schmid', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom. Electronic address: annina.schmid@neuro-research.ch.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.03.007'] 226,32026412,Dehydroepiandrosterone Supplementation May Benefit Women with Asthma Who Have Low Androgen Levels: A Pilot Study.,"INTRODUCTION Among individuals with severe asthma, FEV 1 is low in individuals with low dehydroepiandrosterone (DHEA) sulfate (DHEAS) levels. In the Severe Asthma Research Program (SARP), no women with DHEAS > 200 μg/dL had an FEV 1  < 60% predicted. DHEA has benefited patients with COPD and pulmonary hypertension in small trials. Therefore, we hypothesized that DHEA supplementation may improve FEV 1 in asthmatic women with low DHEAS. METHODS Premenopausal, nonsmoking, otherwise healthy women, 18-50 years old, with mild or moderate asthma and baseline FEV 1  > 60% predicted received 100 mg DHEA orally every 12 h for 2 weeks. Spirometry and DHEAS were measured at the initial visit and 2 weeks later, after completion of DHEA treatment. Based on our previous work, the primary outcome variable for this pilot study was post-albuterol spirometry in the low-DHEAS group. Subjects also continued their other routine asthma management. RESULTS Serum DHEAS increased with DHEA treatment in women with starting DHEAS < 200 µg/dL: this increase was from 71 ± 23 to 725 ± 295 µg/dL (n = 10; p = 0.0001). The increase in the high-DHEAS group was smaller. Post-albuterol FEV 1 increased by 51 mL, from 3.026 ± 0.5 to 3.077 ± 0.49 L (n = 10; p = 0.034 by paired t test, significant after Bonferroni), in women with low DHEAS. In the high-DHEAS group (baseline DHEAS ≥ 200 µg/dl), post-albuterol FEV 1 did not change significantly (n = 3, p = NS). Three subjects were excluded: one had comorbid COPD, one could not perform spirometry, and one did not take the DHEA. There were no adverse effects of DHEA treatment in this trial. CONCLUSIONS Endocrine treatments (corticosteroids) are a mainstay of anti-inflammatory management for moderate and severe asthma. Their use has improved asthma outcomes. Androgens also reduce airway inflammation and promote airway smooth muscle relaxation, but are rarely used clinically for asthma treatment. Our results suggest that the over-the-counter steroid DHEA may improve lung function in asthma outcomes among women with DHEAS < 200 ug/dL.",2019,"FEV 1 increased by 51 mL, from 3.026 ± 0.5 to 3.077 ± 0.49 L (n = 10; p = 0.034 by paired t test, significant after Bonferroni), in women with low DHEAS.","['individuals with severe asthma, FEV 1 is low in individuals with low dehydroepiandrosterone (DHEA) sulfate (DHEAS) levels', 'asthmatic women with low DHEAS', 'Three subjects were excluded: one had comorbid COPD, one could not perform spirometry, and one did not take the DHEA', 'women with DHEAS\u2009', 'Women with Asthma', 'Premenopausal, nonsmoking, otherwise healthy women, 18-50 years old, with mild or moderate asthma and baseline FEV', '200\xa0μg', 'patients with COPD and pulmonary hypertension in small trials', 'women with DHEAS\u2009<\u2009200 ug/dL', 'Who Have Low Androgen Levels']","['Dehydroepiandrosterone Supplementation', 'Endocrine treatments (corticosteroids', 'DHEA', 'DHEA supplementation', 'Post-albuterol']","['FEV 1', 'lung function', 'Spirometry and DHEAS']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0201983', 'cui_str': 'Dehydroepiandrosterone sulfate level'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0445106', 'cui_str': 'Not performed (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439271', 'cui_str': 'ug/dL'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}]",3.0,0.233517,"FEV 1 increased by 51 mL, from 3.026 ± 0.5 to 3.077 ± 0.49 L (n = 10; p = 0.034 by paired t test, significant after Bonferroni), in women with low DHEAS.","[{'ForeName': 'Nadzeya', 'Initials': 'N', 'LastName': 'Marozkina', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Zein', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Logan', 'Affiliation': ""Rainbow Babies and Children's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Veri', 'Affiliation': ""Rainbow Babies and Children's Hospital, Cleveland, OH, USA.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gaston', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA. begaston@iu.edu.'}]",Pulmonary therapy,['10.1007/s41030-019-00101-9'] 227,32203675,Comparison of Tendon Lengthening With Traditional Versus Accelerated Rehabilitation After Achilles Tendon Repair: A Prospective Randomized Controlled Trial.,"BACKGROUND Early weightbearing protocols after Achilles tendon repair promote mobilization, yet little is known about their effect on tendon lengthening. PURPOSE To evaluate tendon lengthening after Achilles tendon repair with accelerated rehabilitation. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon. Patients were randomized into either a traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group. The primary outcome of the study was postoperative tendon elongation as measured by radiostereometric beads. Secondary outcomes included Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score. RESULTS All 18 patients included in the final analysis were found to have significant tendon lengthening after surgery, with a mean lengthening of 15.9 mm. No significant differences were found in overall lengthening between the traditional and accelerated rehabilitation groups (15.3 ± 4.5 vs 16.4 ± 4.7 mm, respectively; P = .33) at final follow-up. The repair site in each group was found to lengthen more than the intratendinous site (traditional group, 13.2 vs 2.1 mm; accelerated group, 16.8 vs -0.4 mm); however, no difference in lengthening was seen between groups ( P = .82 and P = .31, respectively). The greatest amount of lengthening occurred between 2 and 6 weeks, and the least amount of lengthening occurred between 6 and 12 weeks, with no difference between the traditional and accelerated groups at these time points ( P = .84 and P = .38, respectively). No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54). CONCLUSION This study's findings demonstrate that all patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery. No difference was found in tendon lengthening (repair site or intratendinous) at any time point between patients undergoing traditional versus accelerated rehabilitation postoperatively. The greatest amount of lengthening was found to occur between 2 and 6 weeks postoperatively, and tendon lengthening decreased significantly after 6 weeks. REGISTRATION NCT04050748 (ClinicalTrials.gov identifier).",2020,"No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54). ","['Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon', 'patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery', 'After Achilles Tendon Repair']","['Lengthening With Traditional Versus Accelerated Rehabilitation', 'traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group', 'tendon lengthening after Achilles tendon repair with accelerated rehabilitation', 'Tendon']","['ankle range of motion (dorsiflexion', 'tendon lengthening (repair site or intratendinous', 'greatest amount of lengthening', 'least amount of lengthening', 'Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score', 'overall lengthening', 'postoperative tendon elongation', 'tendon lengthening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}]","[{'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1318107', 'cui_str': 'Loadbearing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}]","[{'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0441593', 'cui_str': 'Tendon Lengthening'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}]",18.0,0.140827,"No differences were noted in ankle range of motion (dorsiflexion, P = .16; plantarflexion, P = .08) or outcome scores (ATRS, P = .56; PROMIS PI-SF, P = .54). ","[{'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Okoroha', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Ussef', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Toufic R', 'Initials': 'TR', 'LastName': 'Jildeh', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Lafi S', 'Initials': 'LS', 'LastName': 'Khalil', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Hasan', 'Affiliation': 'Tulane University Medical School, New Orleans, Louisiana, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bench', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Ferras', 'Initials': 'F', 'LastName': 'Zeni', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Eller', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Moutzouros', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520909389'] 228,31567357,Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial.,"OBJECTIVES A randomized controlled trial was conducted to test the hypothesis that povidone-iodine (PVI) irrigation versus no irrigation (NI) reduces postoperative intra-abdominal abscess (IAA) in children with perforated appendicitis. METHODS A 100 patient pilot randomized controlled trial was conducted. Consecutive patients with acute perforated appendicitis were randomized (1:1) to PVI or NI from April 2016 to March 2017 and followed for 1 year. Patients and postoperative providers were blinded to allocation. The primary endpoint was 30-day image-confirmed IAA. Secondary outcomes included initial and total 30-day length of stay (LOS), emergency department (ED) visits, and readmissions. Intention-to-treat analyses were performed to estimate the probability of clinical benefit using Bayesian regression models (an optimistic prior for the primary outcome and neutral priors for secondary outcomes). Frequentist statistics were also used. RESULTS Baseline characteristics were similar between treatment arms. The PVI arm had 12% postoperative IAA versus 16% in the NI arm (relative risk 0.72, 95% credible interval 0.38-1.23). Bayesian analysis estimates 89% probability that PVI reduces IAA. High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS. The probability of benefit in reduction of total 30-day LOS in PVI patients was 96% and was significant (P = 0.05) on frequentist analysis. CONCLUSIONS PVI irrigation for perforated appendicitis in children demonstrated a strong probability of reduction in postoperative IAA with a high probability of decreased LOS. With the favorable probability of benefit in all outcomes, this pilot study serves as evidence to continue a definitive trial.",2020,"High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS.","['children with perforated appendicitis', 'Consecutive patients with acute perforated appendicitis', 'Pediatric Perforated Appendicitis']","['povidone-iodine (PVI) irrigation versus no irrigation (NI', 'PVI irrigation', 'Povidone-iodine Irrigation']","['30-day image-confirmed IAA', 'ED visits and readmissions, and shorter initial and total 30-day LOS', 'total 30-day LOS', 'postoperative IAA', 'initial and total 30-day length of stay (LOS), emergency department (ED) visits, and readmissions', 'postoperative intra-abdominal abscess (IAA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0854119', 'cui_str': 'Perforated Appendicitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0274404', 'cui_str': 'Postoperative intra-abdominal abscess (disorder)'}]",,0.324713,"High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS.","[{'ForeName': 'Kathryn Tinsley', 'Initials': 'KT', 'LastName': 'Anderson', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Luke Randall', 'Initials': 'LR', 'LastName': 'Putnam', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Marisa Angeline', 'Initials': 'MA', 'LastName': 'Bartz-Kurycki', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Emma Catherine', 'Initials': 'EC', 'LastName': 'Hamilton', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yafi', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Mary Thomas', 'Initials': 'MT', 'LastName': 'Austin', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Akemi Lorraine', 'Initials': 'AL', 'LastName': 'Kawaguchi', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Lillian Shiow-Yu', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'Kevin Patrick', 'Initials': 'KP', 'LastName': 'Lally', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}, {'ForeName': 'KuoJen', 'Initials': 'K', 'LastName': 'Tsao', 'Affiliation': 'McGovern Medical School, University of Texas Health Sciences Center at Houston, Department of Pediatric Surgery, Houston, TX.'}]",Annals of surgery,['10.1097/SLA.0000000000003398'] 229,31889508,Impact of Daily Preventive Zinc or Therapeutic Zinc Supplementation for Diarrhea on Plasma Biomarkers of Environmental Enteric Dysfunction among Rural Laotian Children: A Randomized Controlled Trial.,"Environmental enteric dysfunction (EED) may be ameliorated by zinc supplementation. The objective of this study was to investigate the impact of different forms of zinc supplementation on biomarkers of EED (i.e., plasma citrulline, kynurenine, and tryptophan concentrations and the kynurenine:tryptophan [KT] ratio) among young Laotian children. In a double-blind randomized controlled trial, 3,407 children aged 6-23 months were randomized into one of four groups: daily preventive zinc dispersible tablets (PZ; 7 mg zinc), daily multiple micronutrient powders (MNP; 10 mg zinc, 6 mg iron, and 13 other micronutrients), therapeutic zinc supplements for diarrhea treatment (TZ; 20 mg/day for 10 days), or daily placebo powder, and followed up for ∼36 weeks. Plasma samples at baseline and endline for 359 children were analyzed for citrulline, kynurenine, and tryptophan concentrations. At baseline, the prevalence of stunting and zinc deficiency was 37% and 76.5%, respectively. The mean plasma citrulline, kynurenine, and tryptophan concentrations were 24.6 ± 5.4 µmol/L, 3.27 ± 0.83 µmol/L, and 72.3 ± 12.9 µmol/L, respectively; the mean KT ratio (×1,000) was 45.9 ± 12.0. At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P > 0.05). In this population, PZ, MNP, and TZ had no overall effect on plasma concentrations of citrulline, kynurenine, and tryptophan, or the KT ratio. The need remains to better understand the etiology of EED, and the development of biomarkers to diagnose EED and evaluate the impact of interventions.",2020,"At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P > 0.05).","['3,407 children aged 6-23 months', '359 children', 'young Laotian children', 'Rural Laotian Children']","['Daily Preventive Zinc and Therapeutic Zinc Supplementation', 'zinc supplementation', 'daily preventive zinc dispersible tablets (PZ; 7 mg zinc), daily multiple micronutrient powders (MNPs; 10 mg zinc, 6 mg iron, and 13 other micronutrients), therapeutic zinc supplements for diarrhea treatment (TZ; 20 mg/day for 10 days), or daily placebo powder']","['prevalence of stunting and zinc deficiency', 'biomarkers of EED (i.e., plasma citrulline, kynurenine, and tryptophan concentrations and the kynurenine:tryptophan [KT] ratio', 'plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio', 'plasma concentrations of citrulline, kynurenine, and tryptophan, or the KT ratio', 'mean plasma citrulline, kynurenine, and tryptophan concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0022818', 'cui_str': 'Benzenebutanoic acid, alpha,2-diamino-gamma-oxo-'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",359.0,0.334817,"At endline, neither plasma citrulline, kynurenine, or tryptophan concentrations, nor the KT ratio differed among intervention groups ( P > 0.05).","[{'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Chidchamai', 'Initials': 'C', 'LastName': 'Kewcharoenwong', 'Affiliation': 'Faculty of Associated Medical Sciences, The Centre for Research and Development of Medical Diagnostic Laboratories, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Ganjana', 'Initials': 'G', 'LastName': 'Lertmemongkolchai', 'Affiliation': 'Faculty of Associated Medical Sciences, The Centre for Research and Development of Medical Diagnostic Laboratories, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Gertrud U', 'Initials': 'GU', 'LastName': 'Schuster', 'Affiliation': 'Agricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis, California.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'Agricultural Research Service, Western Human Nutrition Research Center, US Department of Agriculture, Davis, California.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0584'] 230,31985125,A Randomized Trial of Real-Time Geriatric Assessment Reporting in Nonelectively Hospitalized Older Adults with Cancer.,"BACKGROUND Hospitalized older adults have significant geriatric deficits that may lead to poor outcomes. We conducted a randomized trial to investigate the effectiveness of providing clinicians with a real-time geriatric assessment (GA) report in nonelectively hospitalized older patients with cancer. SUBJECTS, MATERIALS, AND METHODS We developed a web-based software platform for administering a modified GA (Cancer 2005;104:1998-2005) to older (>70 years) nonelectively hospitalized patients with pathologically confirmed malignancy. Patients were randomized to have their GA report provided to their treating clinicians (Intervention arm) or not provided (Control arm). RESULTS Our study included 135 patients, median age 76 years, 52% female, 75% white, 21% black, 79% greater than high school education, 59% married, and 17% living alone. All patients had at least one GA-identified deficit, including physical function deficits (90%), cognitive impairment (22%), >5 comorbidities (28%), polypharmacy (>9 medications; 38%), weight loss ≥10% in the past 6 months (40%), anxiety (32%), or depression (30%). There was no difference between the Intervention (6%) and Control arms (9%) in the proportion of patients who were referred by their clinical team for an intervention to address a deficit (p = .53). CONCLUSION Many older nonelectively hospitalized patients with cancer have geriatric deficits that are amenable to evidence-based interventions. Real-time GA reports provided to the care team prior to discharge did not influence provider referral for such interventions. There is a need for systems-level interventions to address deficits in this vulnerable patient population. IMPLICATIONS FOR PRACTICE Geriatric deficits are common in hospitalized older adults with cancer and lead to poor outcomes. Addressing modifiable deficits represents an appealing way to improve outcomes. Widespread geriatrician consultation is impractical owing to resource and personnel constraints. This work tested whether prompt delivery of a mostly self-administered, web-based geriatric assessment report to clinicians improved referral rates for evidence-informed interventions. It confirmed frequent geriatric deficits and high readmission rates in this population but found that real-time geriatric assessment reporting did not influence provider referral for evidence-informed interventions on geriatric assessment identified deficits. These findings highlight the need for systems-level intervention to improve outcomes in this vulnerable patient population.",2020,"There was no difference between the Intervention (6%) and Control arms (9%) in the proportion of patients who were referred by their clinical team for an intervention to address a deficit (p = .53). ","['135 patients, median age 76 years, 52% female, 75% white, 21% black, 79% greater than high school education, 59% married, and 17% living alone', 'older nonelectively hospitalized patients with cancer', 'Nonelectively Hospitalized Older Adults with Cancer', 'hospitalized older adults with cancer', 'older (>70\u2009years) nonelectively hospitalized patients with pathologically confirmed malignancy', 'nonelectively hospitalized older patients with cancer', 'Hospitalized older adults']","['GA report provided to their treating clinicians (Intervention arm) or not provided (Control arm', 'clinicians with a real-time geriatric assessment (GA']","['cognitive impairment', 'weight loss', 'referral rates', 'anxiety', 'physical function deficits']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1634625', 'cui_str': 'Percent live'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3661900', 'cui_str': 'Not provided (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",135.0,0.0208177,"There was no difference between the Intervention (6%) and Control arms (9%) in the proportion of patients who were referred by their clinical team for an intervention to address a deficit (p = .53). ","[{'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Jolly', 'Affiliation': 'Division of Hematology and Oncology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mariano', 'Affiliation': 'Royal Columbian Hospital Medical Oncology, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Markowski', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sharanda', 'Initials': 'S', 'LastName': 'Kirk', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Perlmutt', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Jones', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Suel Ki', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kirsten A', 'Initials': 'KA', 'LastName': 'Nyrop', 'Affiliation': 'Division of Hematology and Oncology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busby-Whitehead', 'Affiliation': 'Center for Aging and Health/Division\u2009of Geriatric Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Muss', 'Affiliation': 'Division of Hematology and Oncology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0581'] 231,32250836,"Effect of a brief progressive resistance training program in hospital porters on pain, work ability, and physical function.","BACKGROUND Hospital porters are possibly exposed to the greatest mechanical loads within the hospital environment. However, the evidence about preventive strategies in this population is scarce. OBJECTIVE To investigate the effect of a workplace-based progressive resistance-training program on musculoskeletal pain among hospital porters. METHOD A total of 37 hospital porters (27 women, 10 men) participated. Participants allocated to the intervention group performed five brief resistance training sessions/week, for 9 weeks during working hours at the hospital. Intensity was progressively increased. Participants allocated to the control group maintained their usual physical activity. The primary outcome was pain assessed with the patient global impression of pain change scale. Secondary outcome measures were average pain intensity, work ability, use of analgesics, and physical function. Additionally, perceived general changes were evaluated at follow-up: wellness, satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues. RESULTS For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group. Significant between-group interactions were found for work impairment due to diseases (d = -1.2), hips/thighs pain (d = 0.7), ankles/feet pain (d = 0.4), the Biering-Sorensen test (d = -0.6) and the push-ups test (d = -2.3) favoring the intervention group. All between-group differences were clinically important. CONCLUSION A progressive resistance training program performed at the workplace is feasible and effective in reducing musculoskeletal pain and improving work ability and physical function among hospital porters.",2020,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","['musculoskeletal pain among hospital porters', 'A total of 37 hospital porters (27 women, 10 men) participated']","['workplace-based progressive resistance-training program', 'progressive resistance training program', 'brief resistance training sessions', 'control group maintained their usual physical activity']","['work satisfaction', 'pain assessed with the patient global impression of pain change scale', 'musculoskeletal pain and improving work ability and physical function', 'satisfaction at work, desire to exercise, motivation to eat healthy, energy to be with family and friends, and socialization with colleagues', 'desire for practicing exercise', 'greater wellbeing', 'average pain intensity, work ability, use of analgesics, and physical function', 'ankles/feet pain', 'hips/thighs pain', 'Intensity', 'pain, work ability, and physical function', 'lower general pain']","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0402674', 'cui_str': 'Hospital porter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",37.0,0.0521316,"For the primary outcome, the intervention group showed lower general pain (p < 0.0001) and greater wellbeing (p < 0.0001), work satisfaction (p = 0.0048), desire for practicing exercise (p = 0.0007), and energy (p = 0.0474) compared with the control group.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Escriche-Escuder', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; Department of Physiotherapy, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain; National Research Centre for the Working Environment, Copenhagen, Denmark. Electronic address: joaquin.calatayud@uv.es.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark; Sport Sciences, Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Aiguadé', 'Affiliation': 'Department of Nursing and Physiotherapy, University of Lleida, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102162'] 232,32320061,Effects of acupuncture versus cognitive behavioral therapy on cognitive function in cancer survivors with insomnia: A secondary analysis of a randomized clinical trial.,"BACKGROUND Cancer-related cognitive impairment is a prevalent, disruptive condition potentially exacerbated by sleep disturbances. The current study was performed to evaluate the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on objective and subjective cognitive function in cancer survivors with insomnia. METHODS Using data from a randomized clinical trial (160 survivors) that compared acupuncture versus CBT-I for insomnia occurring in cancer survivors, the authors analyzed cognitive outcomes and their relationship to insomnia symptoms. Analysis was limited to 99 patients who reported baseline cognitive difficulties. Interventions were delivered over 8 weeks. Objective attention, learning, and memory were evaluated using the Buschke Selective Reminding Test. Subjective cognitive function was assessed using the Brown Attention-Deficit Disorder Scales. Insomnia symptoms were assessed using the Insomnia Severity Index. All outcomes were collected at baseline, week 8, and week 20. RESULTS From baseline to week 8, acupuncture produced statistically significant within-group improvements in objective attention (Cohen D, 0.29), learning (Cohen D, 0.31), and memory (Cohen D, 0.33) that persisted to week 20 (all P < .05), whereas CBT-I produced a statistically significant within-group improvement in objective attention from baseline to week 20 (Cohen D, 0.50; P < .05); between-group differences were not statistically significant. Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant. In the acupuncture group, patients with clinically meaningful responses with regard to insomnia symptoms demonstrated a significantly greater improvement in subjective cognitive function compared with those without clinically meaningful insomnia responses (P = .006). CONCLUSIONS Among cancer survivors with insomnia, both acupuncture and CBT-I produced significant improvements in objective and subjective cognitive function. However, the effect sizes varied and only survivors in the acupuncture group demonstrated a significant relationship between cognitive and sleep outcomes. These preliminary findings warrant further investigation to guide the personalized management of patients with cancer-related cognitive impairment.",2020,Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant.,"['patients with cancer-related cognitive impairment', '99 patients who reported baseline cognitive difficulties', 'cancer survivors with insomnia']","['acupuncture', 'cognitive behavioral therapy', 'acupuncture versus cognitive behavioral therapy']","['subjective cognitive function', 'Brown Attention-Deficit Disorder Scales', 'objective attention', 'cognitive and sleep outcomes', 'Insomnia symptoms', 'objective and subjective cognitive function', 'Subjective cognitive function', 'Objective attention, learning, and memory', 'Insomnia Severity Index', 'cognitive function', 'meaningful insomnia responses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",160.0,0.120503,Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant.,"[{'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'Liou', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Department of Psychology, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Q Susan', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.32847'] 233,32315508,Insulin glargine 300 U/mL and insulin degludec: A review of the current evidence comparing these two second-generation basal insulin analogues.,"For most people with type 2 diabetes (T2D), treatment intensification with the addition of basal insulin therapy is required to maintain glycaemic control. However, this often does not happen in real-life practice promoting the development of long-term diabetes-related complications. The second-generation basal insulin analogues glargine 300 U/mL (Gla-300) and degludec (IDeg) provide pharmacokinetic and pharmacodynamic improvements that may allow them to be more effective in appropriately managing diabetes compared with first-generation basal insulin analogues. Both Gla-300 and IDeg have been extensively studied vs the first-generation basal insulin glargine 100 U/mL, demonstrating comparable efficacy in terms of glycaemic control, and a lower risk of hypoglycaemia. The BRIGHT randomized controlled trial is the first direct comparison of the efficacy and safety profiles of Gla-300 and IDeg in patients with T2D. Moreover, real-world data have been used to assess the effectiveness of these basal insulins during routine clinical practice. Further research is required to determine if the properties of Gla-300 and IDeg may lead to improvements in healthcare-related costs and the quality of life of patients, which are important factors for informing clinical decisions.",2020,The BRIGHT randomised controlled trial is the first direct comparison of the efficacy and safety profiles of Gla-300 and IDeg in patients with T2D.,"['people with type 2 diabetes (T2D', 'patients with T2D']",['Insulin glargine 300 U/mL and insulin degludec'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]",[],,0.0457032,The BRIGHT randomised controlled trial is the first direct comparison of the efficacy and safety profiles of Gla-300 and IDeg in patients with T2D.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'Division of Endocrinology and Metabolism, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Escondido, California, USA.'}, {'ForeName': 'Didac', 'Initials': 'D', 'LastName': 'Mauricio', 'Affiliation': 'Department of Endocrinology & Nutrition, CIBER of Diabetes and Associated Metabolic Diseases, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Diabetology Endocrinology Nutrition, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, Paris, France.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3329'] 234,29541464,Comparison of surgical outcomes and complications between the Harmonic FOCUS and conventional surgery for open thyroidectomy.,"The aim of the present study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in thyroid surgery. Patients with resectable thyroid cancer and Basedow's disease were assigned to ultrasonic scalpel or conventional technique (knot-tying and electrocoagulation). The present study used the Harmonic FOCUS ® (HF) as an ultrasonic scalpel. Between February 2013 and May 2016, 45 patients were enrolled into the study. Duration of the surgery was significantly decreased in the HF group compared with the conventional surgery (CS) group (median 142 vs. 151 min; P=0.0406). Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490). Duration of drain placement and length of hospitalization stay were similar in the two groups. Furthermore, the overall incidence of postoperative complications did not differ between the two groups. Overall, the present study suggests that open thyroidectomy using the HF is safe and effective and not associated with any increase in complications.",2018,"Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490).","['Between February 2013 and May 2016, 45 patients were enrolled into the study', ""Patients with resectable thyroid cancer and Basedow's disease""]","['Harmonic FOCUS ® (HF', 'ultrasonic scalpel or conventional technique (knot-tying and electrocoagulation', 'ultrasonic scalpel', 'conventional surgery (CS', 'Harmonic FOCUS and conventional surgery', 'conventional technique']","['overall incidence of postoperative complications', 'Intraoperative blood loss and total volume of drainage fluid', 'Duration of the surgery', 'complications', 'Duration of drain placement and length of hospitalization stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C0018213', 'cui_str': 'Graves Disease'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",45.0,0.0362551,"Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490).","[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Hokkaido 060-8543, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Kutomi', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Hokkaido 060-8543, Japan.'}, {'ForeName': 'Fukino', 'Initials': 'F', 'LastName': 'Satomi', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Hokkaido 060-8543, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shima', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Hokkaido 060-8543, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Public Health, Sapporo Medical University, Sapporo, Hokkaido 060-8556, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Takemasa', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Hokkaido 060-8543, Japan.'}]",Molecular and clinical oncology,['10.3892/mco.2018.1569'] 235,30950656,Relationship of obesity to adverse events in myocardial infarction patients without primary percutaneous coronary intervention: results from the Occluded Artery Trial (OAT).,"Objective: Our goal was to investigate the ""obesity paradox"" in myocardial infarction populations without primary percutaneous coronary intervention (PPCI). Methods: The Occluded Artery Trial (OAT, Clinicaltrials.gov: NCT00004562) is a randomized, multicenter study to investigate the influence of routine percutaneous coronary intervention (PCI) on the clinical outcomes of myocardial infarction patients without PPCI. We stratified these patients into three groups according to body mass index (BMI): normal, 18.5 kg/m 2  ≤ BMI < 25 kg/m 2 ; overweight, 25 kg/m 2  ≤ BMI < 30 kg/m 2 ; obese, BMI ≥ 30 kg/m 2 . The purpose of our study was to investigate the effects of BMI on the primary endpoint (all-cause mortality) and the secondary endpoint (cardiac death, non-cardiac death or New York Heart Association [NYHA] class IV heart failure) in the population enrolled in the OAT. Results: A total of 2153 patients (99.4%) constituted the final study population. We found that obese patients were younger and were more likely to have cardiovascular risk factors compared with other BMI groups. A U-shaped relationship was observed between BMI and all-cause mortality. The adjusted hazard ratios (HRs) were 0.892 (95% CI: 0.658-1.210, p  = .460) for normal weight patients and 0.671 (95% CI: 0.508-0.888, p  = .013) for overweight patients compared with obese patients. The same pattern was also observed for non-cardiac death. The adjusted HRs were 0.919 (95% CI: 0.601-1.40, p  = .663) for normal weight patients and 0.524 (95% CI: 0.346-0.792, p  = .004) for overweight patients compared with obese patients. We did not find any statistical differences among BMI categories in terms of cardiac death or NYHA class IV heart failure. Conclusions: A U-shaped relationship was observed between BMI and all-cause mortality or non-cardiac death. Overweight patients have the lowest risk of all-cause mortality, which may be attributed to their having the lowest risk of non-cardiac death of the groups studied.",2019,"The adjusted HRs were 0.919 (95% CI: 0.601-1.40, p = .663) for normal weight patients and 0.524","['myocardial infarction patients without primary percutaneous coronary intervention', '2153 patients (99.4%) constituted the final study population', 'Overweight patients', 'patients into three groups according to body mass index (BMI): normal, 18.5\u2009kg/m 2 \u2009≤\u2009BMI\u2009<\u200925\u2009kg/m 2 ; overweight, 25\u2009kg/m 2 \u2009≤\u2009BMI\u2009<\u200930\u2009kg/m 2 ; obese, BMI\u2009≥\u200930\u2009kg/m 2 ', 'myocardial infarction populations without primary percutaneous coronary intervention (PPCI', 'myocardial infarction patients without PPCI', 'obese patients', 'population enrolled in the OAT']",['routine percutaneous coronary intervention (PCI'],"['adjusted hazard ratios (HRs', 'cardiac death or NYHA class IV heart failure', 'cardiovascular risk factors', 'secondary endpoint (cardiac death, non-cardiac death or New York Heart Association [NYHA] class IV heart failure']","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0441888', 'cui_str': 'Class 4 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",2153.0,0.074295,"The adjusted HRs were 0.919 (95% CI: 0.601-1.40, p = .663) for normal weight patients and 0.524","[{'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xing', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Junyu', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jiabing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xinqun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Geriatrics, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Current medical research and opinion,['10.1080/03007995.2019.1603993'] 236,30974973,"Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes.","Objective: Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patient-reported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch 1 versus insulin glargine U100 (glargine U100) with SoloStar 2 pen injector. Methods: In this randomized, multicenter (USA), open-label, crossover, treat-to-target study (NCT01570751), patients with T2D using high-dose insulin (≥81 U/day from vials) were randomized ( n  = 145) 1:1 to 16 weeks of degludec U200 (3 mL FlexTouch) followed by 16 weeks of glargine U100 (3 mL SoloStar) or vice versa. PRO questionnaires assessed treatment impact and patient preference of pen injectors. Results: Significantly more patients ( p  < .01) considered FlexTouch ""extremely easy"" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were ""very"" or ""extremely confident"" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar. Significantly more were ""not at all bothered"" by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch. Significantly more patients preferred degludec treatment with FlexTouch (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch compared with SoloStar with glargine U100. Conclusions: In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch versus SoloStar pen injectors.",2019,"Significantly more patients (p < .01) considered FlexTouch ""extremely easy"" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were ""very"" or ""extremely confident"" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar.","['patients with T2D using high-dose insulin (≥81\u2009U/day from vials', 'patients with type 2 diabetes']","['pen injector with insulin degludec versus a pen injector with insulin glargine U100', 'FlexTouch 1 versus insulin glargine U100 (glargine U100) with SoloStar 2 pen injector', 'FlexTouch', 'glargine U100 (3\u2009mL SoloStar) or vice versa']","['PRO questionnaires assessed treatment impact and patient preference of pen injectors', 'device size', 'complexity, adherence, efficacy of treatment and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456683', 'cui_str': 'unit/day'}, {'cui': 'C1706398', 'cui_str': 'Vil'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.14689,"Significantly more patients (p < .01) considered FlexTouch ""extremely easy"" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were ""very"" or ""extremely confident"" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar.","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East, Greenville, NC, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'Brod', 'Affiliation': 'The Brod Group, Mill Valley, CA, USA.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Håkan-Bloch', 'Affiliation': 'Global Market Access, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sparre', 'Affiliation': 'Medical & Science Devices & Titration, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Louis B', 'Initials': 'LB', 'LastName': 'Chaykin', 'Affiliation': 'Meridien Research, Bradenton, FL, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1605769'] 237,32179132,Outcomes for Hyperthermia Combined with Concurrent Radiochemotherapy for Patients with Cervical Cancer.,"PURPOSE To evaluate the effect of hyperthermia combined with concurrent radiochemotherapy (RCT) and treatment-related toxicity in patients with cervical cancer (CC) stage IB-IV. METHODS AND MATERIALS This study was conducted between 2009 and 2013 in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV CC. The patients were randomly assigned into 2 treatment groups: RCT and RCT plus hyperthermia (RCHT). Five-year survival, treatment-related toxicity, and other prognostic factors were evaluated. RESULTS Three hundred seventy-three patients completed treatment and were analyzed by per-protocol (PP) analysis. The 5-year overall survival (OS) in the RCHT group (81.9%) was better than that in RCT group (72.3%), and the log-rank test showed a statistically significant difference between the 2 groups (P = .040). Univariate and multivariate Cox regression analysis for 5-year OS showed a statistically significant difference (P = .043, P = .045, respectively). The 5-year local relapse-free survival in RCHT (86.8%) was also better than that in RCT (82.7%), but the difference was not significant. Acute or late toxicity was not significantly different between the 2 groups. Advanced clinical stage (FIGO) and larger tumor size showed higher risk of death and a relatively poor prognosis in univariate and multivariate analysis. CONCLUSIONS The study confirmed that hyperthermia combined with RCT yielded a better 5-year OS in CC. Acute and late toxicity was similar between the RCT and RCHT groups. Clinical stage (FIGO) and tumor size were independent prognostic factors in CC.",2020,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"['373 patients completed treatment and were analyzed by per protocol (PP) analysis', '2009 and 2013 in CC patients with the International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV', 'patients with cervical cancer (CC) stage IB-IV', 'patients with cervical cancer']","['RCT', 'RCT and RCT plus hyperthermia (RCHT', 'hyperthermia combined with concurrent radiochemotherapy', 'HT combined to RCT', 'hyperthermia (HT) combined with concurrent radiochemotherapy (RCT']","['5-year survival', '5-year OS', '5-year overall survival (OS', 'Acute or late toxicity', 'Clinical stage (FIGO) and tumor size', '5-year local relapse-free survival (LRFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.250432,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Che', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yingbing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Meng', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jiquan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Beina', 'Initials': 'B', 'LastName': 'Hui', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: chenhwdr@hotmail.com.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.006'] 238,31542942,Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial.,"BACKGROUND Once-weekly exenatide (EQW) had a neutral effect on hospitalization for heart failure (HHF) in the EXSCEL study (Exenatide Study of Cardiovascular Event Lowering), with no differential treatment effect on major adverse cardiac events by baseline heart failure (HF) status. EQW's effects on secondary end points based on HHF status have not been reported. The objective was to explore the effects of EQW on secondary end points in patients with and without baseline HF and test the effects of EQW on recurrent HHF events. METHODS The prespecified analysis of the randomized controlled EXSCEL trial, which enrolled patients with type 2 diabetes mellitus with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each major adverse cardiac event component, first HHF, and repeat HHF, by baseline HF status (regardless of ejection fraction). A subgroup analysis of the population stratified by preserved or reduced baseline ejection fraction was performed. RESULTS Of 14 752 EXSCEL participants, 2389 (16.2%) had HF at baseline. Compared with those without HF at baseline, patients with preexisting HF were older, and more likely to be male and white, with a higher burden of other cardiovascular diseases. Overall, those assigned to EQW had a lower incidence of all-cause death (hazard ratio [HR], 0.86 [95% CI, 0.77-0.97]) and the composite outcome of all-cause death or HHF (HR, 0.89 [95% CI, 0.80-0.99]). When stratified by presence or absence of baseline HF, there was no observed reduction in all-cause death with EQW with baseline HF (HR, 1.05 [95% CI, 0.85-1.29]), while the risk of mortality was reduced with EQW in the no-HF group (HR, 0.79 [95% CI, 0.68-0.92]) with an interaction P value of 0.031. The reduction in all-cause death or HHF seen with EQW in patients without baseline HF (HR, 0.81 [95% CI, 0.71-0.93]) was not seen in patients with baseline HF (HR, 1.07 [95% CI, 0.89-1.29]; interaction P =0.015). First, plus recurrent, HHF was reduced in the exenatide group versus placebo (HR, 0.82 [95% CI, 0.68-0.99]; P =0.038). CONCLUSIONS In EXSCEL, the use of EQW in patients with or without HF was well tolerated, but benefits of EQW on reduction in all-cause death and first hospitalization for HF were attenuated in patients with baseline HF. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov. Unique identifier: NCT01144338.",2019,"Overall, those assigned to EQW had a lower incidence of all-cause death (HR 0.86, 95%CI 0.77-0.97) and the composite outcome of all-cause death or hHF (HR 0.89, 95%CI 0.80-0.99).","['enrolled patients with type 2 diabetes with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each MACE component, first hHF and repeat hHF by baseline HF status (regardless of ejection fraction', 'patients with and without baseline HF', 'Patients With Type 2 Diabetes With and Without Heart Failure and Heart Failure-Related Outcomes']","['placebo', 'EQW', 'Once-Weekly Exenatide', 'exenatide (EQW']","['risk of mortality', 'recurrent hHF', 'major adverse cardiac events (MACE) by baseline heart failure (HF) status', 'incidence of all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.396181,"Overall, those assigned to EQW had a lower incidence of all-cause death (HR 0.86, 95%CI 0.77-0.97) and the composite outcome of all-cause death or hHF (HR 0.89, 95%CI 0.80-0.99).","[{'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Diabetes Unit, The E. Wolfson Medical Center, Sackler Tel-Aviv University, Israel (J.W.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Murin', 'Affiliation': 'University Hospital, Bratislava, Slovakia (J.M.).'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Öhman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Reicher', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, United Kingdom (R.R.H.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041659'] 239,31802732,Clinical Outcome of Febrile Tanzanian Children with Severe Malnutrition Using Anthropometry in Comparison to Clinical Signs.,"Children with malnutrition compared with those without are at higher risk of infection, with more severe outcomes. How clinicians assess nutritional risk factors in febrile children in primary care varies. We conducted a post hoc subgroup analysis of febrile children with severe malnutrition enrolled in a randomized, controlled trial in primary care centers in Tanzania. The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting. Those identified as having severe malnutrition by the algorithms in each arm were prescribed antibiotics and referred to the hospital. From December 2014 to February 2016, 106 febrile children were enrolled and randomized in the parent study, and met the criteria to be included in the present analysis. ePOCT identified 56/57 children with severe malnutrition using anthropometric measures, whereas ALMANACH identified 2/49 children with severe malnutrition using clinical signs. The proportion of clinical failure, defined as the development of severe symptoms by day 7 or persisting symptoms at day 7 (per-protocol), was 1.8% (1/56) in the ePOCT arm versus 16.7% (8/48) in the Algorithm for the MANagement of Childhood illnesses arm (risk difference -14.9%, 95% CI -26.0%, -3.8%; risk ratio 0.11, 95% CI 0.01, 0.83). Using anthropometric measures to identify and manage febrile children with severe malnutrition may have resulted in better clinical outcomes than by using clinical signs alone.",2020,"The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting.","['From December 2014 to February 2016, 106 febrile children', 'Children with malnutrition', 'febrile children with severe malnutrition', 'children with severe malnutrition', 'febrile children with severe malnutrition enrolled in a randomized, controlled trial in primary care centers in Tanzania', 'febrile children in primary care varies', 'Febrile Tanzanian Children with Severe Malnutrition Using Anthropometry in Comparison to Clinical Signs', '56/57 children with severe malnutrition using anthropometric measures, whereas ALMANACH identified 2/49 children with severe malnutrition using clinical signs']",[],['proportion of clinical failure'],"[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",106.0,0.10664,"The clinical outcome of children with severe malnutrition defined by anthropometric measures and clinical signs was compared between two electronic clinical diagnostic algorithms: ePOCT, which uses weight-for-age and mid-upper arm circumference to identify and manage severe malnutrition, and ALMANACH, which uses the clinical signs of edema of both feet and visible severe wasting.","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': 'Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kagoro', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': 'Levine', 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Masimba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Samaka', 'Affiliation': 'Amana Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Sangu', 'Affiliation': 'Dar es Salaam City Council, Dar es Salaam, Tanzania.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Genton', 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': ""D'Acremont"", 'Affiliation': 'Swiss Tropical and Public Health Institute (SwissTPH), University of Basel, Switzerland.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Keitel', 'Affiliation': 'Department of Pediatric Emergency Medicine, University Hospital Bern, Bern, Switzerland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0553'] 240,31832778,Cerebrospinal fluid lipidomics: effects of an intravenous triglyceride infusion and apoE status.,"INTRODUCTION High-fat diets increase risk for Alzheimer's disease, but individuals with the risk gene APOE ε4 (E4) paradoxically have improved memory soon after high fat feeding. Little is known about how dietary lipids affect CNS lipids, especially in older adults. OBJECTIVES We analyzed the lipidomic signature of cerebrospinal fluid (CSF) in older adults who underwent both a saline and TG infusion. We further analyzed these data by E4 carrier status. METHODS Older adults (n = 21, age 67.7 ± 8.6) underwent a 5-h TG and saline infusion on different days in random crossover design; lumbar CSF was collected at the end of the infusion. Lipids were extracted using dichloromethane/methanol and 13 classes of lipids analyzed using the Lipidyzer platform consisting of an AB Sciex 5500 MS/MS QTraps system equipped with a SelexION for differential mobility spectrometry (DMS). Multiple reaction monitoring was used to target and quantify 1070 lipids in positive and negative ionization modes with and without DMS. RESULTS The TG infusion increased total lipids in the CSF, including the appearance of more lipids at the detection limit in the TG samples compared to saline (Chi square p < 0.0001). The infusion increased the total level of diacylglycerols and lysophosphatidylcholines and reduced dihydroceramides. Of the possible 1070 lipids detectable, we found 348 after saline and 365 after TG infusion. Analysis using MetaboAnalyst revealed 11 specific lipids that changed; five of these lipids decreased after TG infusion, and four of them differed by E4 status, but none differed by cognitive diagnosis or sex. CONCLUSION These results in older adults show that blood lipids affect lipid profiles in CSF and such profiles are modified by APOE status. This suggests that how the CNS handles lipids may be important in the AD phenotype.",2019,The infusion increased the total level of diacylglycerols and lysophosphatidylcholines and reduced dihydroceramides.,"['older adults who underwent both a', 'Older adults (n\u2009=\u200921, age 67.7\u2009±\u20098.6) underwent a', 'older adults']","['5-h TG and saline infusion', 'intravenous triglyceride infusion and apoE status', 'saline and TG infusion']","['total level of diacylglycerols and lysophosphatidylcholines and reduced dihydroceramides', 'total lipids']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012262', 'cui_str': 'Diacylglycerols'}, {'cui': 'C0024360', 'cui_str': 'Lysolecithins'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0668446', 'cui_str': 'N-acetylsphinganine'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",1070.0,0.0331142,The infusion increased the total level of diacylglycerols and lysophosphatidylcholines and reduced dihydroceramides.,"[{'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Hanson', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, Department of Medicine, University of Washington, Seattle, WA, USA. hansonaj@uw.edu.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Banks', 'Affiliation': 'Division of Gerontology and Geriatric Medicine, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Northwest Metabolomics Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pepin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Northwest Metabolomics Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Northwest Metabolomics Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, NC, USA.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-019-1627-x'] 241,31086274,The effect of paired corticospinal-motoneuronal stimulation on maximal voluntary elbow flexion in cervical spinal cord injury: an experimental study.,"STUDY DESIGN Randomised, controlled, crossover study. OBJECTIVES Paired corticospinal-motoneuronal stimulation (PCMS) involves repeatedly pairing stimuli to corticospinal neurones and motoneurones to induce changes in corticospinal transmission. Here, we examined whether PCMS could enhance maximal voluntary elbow flexion in people with cervical spinal cord injury. SETTING Neuroscience Research Australia, Sydney, Australia. METHODS PCMS comprised 100 pairs of transcranial magnetic and electrical peripheral nerve stimulation (0.1 Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5 ms before antidromic motoneuronal potentials. On two separate days, sets of five maximal elbow flexions were performed by 11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after PCMS or control (100 peripheral nerve stimuli) conditioning. During contractions, supramaximal biceps brachii stimulation elicited superimposed twitches, which were expressed as a proportion of resting twitches to give maximal voluntary activation. Maximal torque and electromyographic activity were also assessed. RESULTS Baseline median (range) maximal torque was 11 Nm (6-41 Nm) and voluntary activation was 92% (62-99%). Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). CONCLUSIONS Possible explanations for the lack of effect include a potential ceiling effect for voluntary activation, or that PCMS may be less effective for elbow flexors than distal muscles. Despite results, previous studies suggest that PCMS is worthy of further investigation.",2019,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). ","['cervical spinal cord injury', 'Neuroscience Research Australia, Sydney, Australia', '11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after', 'people with cervical spinal cord injury', 'PCMS comprised 100 pairs of']","['PCMS or control (100 peripheral nerve stimuli) conditioning', 'Paired corticospinal-motoneuronal stimulation (PCMS', 'PCMS', 'transcranial magnetic and electrical peripheral nerve stimulation (0.1\u2009Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5\u2009ms before antidromic motoneuronal potentials', 'paired corticospinal-motoneuronal stimulation']","['maximal voluntary elbow flexion', 'voluntary activation', 'Maximal torque and electromyographic activity', 'Baseline median (range) maximal torque']","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0035168'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0436544', 'cui_str': 'Electrical peripheral nerve stimulation (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039062', 'cui_str': 'Synapses'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0859074,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). ","[{'ForeName': 'Siobhan C', 'Initials': 'SC', 'LastName': 'Dongés', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia. janet.taylor@ecu.edu.au.'}]",Spinal cord,['10.1038/s41393-019-0291-3'] 242,31802733,Comparison of School-Based and Community-Wide Mass Drug Administration for Schistosomiasis Control in an Area of Western Kenya with High Initial Schistosoma mansoni Infection Prevalence: A Cluster Randomized Trial.,"We conducted a cluster randomized trial comparing the target population and timing of mass drug administration (MDA) with praziquantel for control of schistosomiasis in villages in western Kenya with high initial prevalence (> 25%) according to a harmonized protocol developed by the Schistosomiasis Consortium for Operational Research and Evaluation. A total of 150 villages were randomized into six treatment arms (25 villages per arm), were assessed at baseline, and received two or four rounds of MDA using community-wide (CWT) or school-based (SBT) treatment over 4 years. In the fifth year, a final evaluation was conducted. The primary outcomes were prevalence and intensity of Schistosoma mansoni infections in children aged 9-12 years, each year their village received MDA. Baseline and year 5 assessments of first-year students and adults were also performed. Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms. Combined arms of villages that received four rounds of treatment had greater reduction than villages in arms that only received two rounds of treatment. Surprisingly, we also found benefits of SBT for first-year primary students and adults, who never received treatment in those arms. Our data support the use of annual SBT for control programs when coupled with attention to infections in younger children and occasional treatment of adults.",2020,"Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms.","['children aged 9-12 years', 'control of schistosomiasis in villages in western Kenya with high initial prevalence (> 25%) according to a harmonized protocol developed by the Schistosomiasis Consortium for Operational Research and Evaluation', 'Schistosomiasis Control in an Area of Western Kenya with High Initial Schistosoma mansoni', 'A total of 150 villages', 'younger children and occasional treatment of adults']","['CWT and SBT MDA', 'mass drug administration (MDA) with praziquantel', 'SBT', 'MDA using community-wide (CWT) or school-based (SBT) treatment', 'School-Based and Community-Wide Mass Drug Administration']","['Infection Prevalence', 'prevalence and intensity of Schistosoma mansoni infections', 'prevalence of infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C4505223', 'cui_str': 'Mass Drug Administration'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036330', 'cui_str': 'Schistosoma mansoni Infection'}]",,0.0890586,"Using Poisson and negative binomial regression with generalized estimating equations, we found similar effects of CWT and SBT MDA treatment strategies in children aged 9-12 years: significant reductions of prevalence of infection in all arms and of heavy-intensity (≥ 400 eggs/gram) infections in most arms but no significant differences between arms.","[{'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Montgomery', 'Affiliation': 'Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Diana M S', 'Initials': 'DMS', 'LastName': 'Karanja', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Maurice R', 'Initials': 'MR', 'LastName': 'Odiere', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0626'] 243,32310680,"The Effects of a Standardized Extract of Centella asiatica on Postlaser Resurfacing Wound Healing on the Face: A Split-Face, Double-Blind, Randomized, Placebo-Controlled Trial.","Background: Centella asiatica , a medicinal plant, has been used traditionally to promote wound healing. Its efficacy on promoting postlaser resurfacing wound healing is lacking. Methods: Thirty individuals with facial acne scars underwent a treatment with 2940 nm Er:YAG laser. Half side of the face was randomized to receive 0.05% w/w ECa 233 gel, a standardized extract of C. asiatica , and the other half a placebo gel. The gels were applied four times daily for 7 days then twice daily for 3 months. Erythema, melanin, and texture index (TI) from Antera3D, ® and skin biophysics were obtained at baseline, days 2, 4, and 7, then every 2 weeks for the first month, and every month for 3 months. Three blinded dermatologists assessed the photographs and provided a grading scale of wound appearances. Results: The ECa 233 treated side exhibited significantly less erythema index over total follow-up by 0.03 U (coefficient = -0.03 [95% CI -0.06 to -0.0006]; p  = 0.046). In keeping with the physicians' assessment that showed significantly higher improvements in skin erythema at days 2, 4, and 7 ( p  = 0.009, 0.0061, 0.012), crusting at days 2 ( p  = 0.02), and general wound appearance at days 2, 4, and 7 ( p  = 0.008, 0.001, 0.044), TI showed a trend toward better outcome in the ECa 233 group. Skin biophysics did not differ between the two groups. Conclusion: ECa 233 might be an option for postlaser treatment to improve wound appearance.",2020,The ECa 233 treated side exhibited significantly less erythema index over total follow-up by 0.03 U (coefficient = -0.03,"['Thirty individuals with facial acne scars', 'Postlaser Resurfacing Wound Healing on the Face']","['ECa', 'Standardized Extract of Centella asiatica', 'Placebo', 'placebo gel']","['Skin biophysics', 'skin erythema', 'general wound appearance', 'Erythema, melanin, and texture index (TI) from Antera3D, ® and skin biophysics', 'wound appearance', 'crusting', 'erythema index']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0772382', 'cui_str': 'Gotu kola'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205204', 'cui_str': 'Crust'}]",,0.177677,The ECa 233 treated side exhibited significantly less erythema index over total follow-up by 0.03 U (coefficient = -0.03,"[{'ForeName': 'Wilawan', 'Initials': 'W', 'LastName': 'Damkerngsuntorn', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pawinee', 'Initials': 'P', 'LastName': 'Rerknimitr', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ratchathorn', 'Initials': 'R', 'LastName': 'Panchaprateep', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Natsinee', 'Initials': 'N', 'LastName': 'Tangkijngamvong', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chanat', 'Initials': 'C', 'LastName': 'Kumtornrut', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kerr', 'Affiliation': 'Center for Excellence in Biostatistics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Mayuree H', 'Initials': 'MH', 'LastName': 'Tantisira', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Burapha University, Chonburi, Thailand.'}, {'ForeName': 'Phisit', 'Initials': 'P', 'LastName': 'Khemawoot', 'Affiliation': 'Preclinical Pharmacokinetics and Interspecies Scaling for Drug Development Research Unit, Chulalongkorn University, Bangkok, Thailand.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0325'] 244,32310691,Efficacy of Momiai in Tibia Fracture Repair: A Randomized Double-Blinded Placebo-Controlled Clinical Trial.,"Objectives: Momiai ( shilajit, mummy, mumie, or mineral pitch) has been used traditionally in different medical systems for the treatment of a variety of ailments since hundreds of years ago. It is a natural substance found in different rocky parts of the world, formed by plants, mineral, and animal remains gradually. There is also worthwhile evidence supporting its oral use for bone repair in Persian medicine. The aim of this study was to evaluate the efficacy and safety of momiai in tibia fracture healing. Design: This study is a randomized double-blinded controlled trial. Settings/Location: Three different hospitals in Tehran, Iran. Subjects: Patients with age range of 18-60 years admitted due to new tibia fracture were enrolled after meeting the inclusion criteria. Interventions: The patients were divided into two groups randomly and received two 500 mg capsules of momiai or placebo for 28 days. Outcome measures: The process of bone healing was assessed by frequent X-ray radiographies and adverse effects were recorded. Results: Totally, 160 patients participated in the study either in two equal intervention or placebo groups. There was no significant difference between groups in terms of demographic and descriptive data. At the end of the study, the mean time of tibial bone union was 129 days in the experimental group, while it was 153 days in the placebo group ( p  < 0.049). There was no significant difference in the reported adverse effects between the two groups ( p  = 0.839). Conclusions: The current study showed that oral consumption of momiai after tibial shaft fracture surgery could be a promising option to reduce the healing time.",2020,There was no significant difference in the reported adverse effects between the two groups ( p  = 0.839). ,"['Three different hospitals in Tehran, Iran', '160 patients participated in the study either in two equal intervention or placebo groups', 'Subjects: Patients with age range of 18-60 years admitted due to new tibia fracture were enrolled after meeting the inclusion criteria', 'Tibia Fracture Repair']","['Momiai ( shilajit, mummy, mumie, or mineral pitch', 'two 500\u2009mg capsules of momiai or placebo', 'Placebo', 'placebo']","['adverse effects', 'healing time', 'process of bone healing was assessed by frequent X-ray radiographies and adverse effects', 'efficacy and safety', 'mean time of tibial bone union']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0066936', 'cui_str': 'mumie'}, {'cui': 'C0026779', 'cui_str': 'Mummies'}, {'cui': 'C0052558', 'cui_str': 'Asphalt'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",160.0,0.416423,There was no significant difference in the reported adverse effects between the two groups ( p  = 0.839). ,"[{'ForeName': 'Seyed Mohammad Hasan', 'Initials': 'SMH', 'LastName': 'Sadeghi', 'Affiliation': 'Traditional Medicine and Materia Medica Research Center, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mehdi', 'Initials': 'SM', 'LastName': 'Hosseini Khameneh', 'Affiliation': 'Department of Orthopedic Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Khodadoost', 'Affiliation': 'Traditional Medicine and Materia Medica Research Center, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Hosseini Kasnavieh', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Gachkar', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rampp', 'Affiliation': 'Clinic of Integrative Medicine, Kliniken Essen Mitte, Medical Faculty University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Pasalar', 'Affiliation': 'Faculty of Medicine, Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0453'] 245,32108022,Medication Adherence During Adjunct Therapy With Statins and ACE Inhibitors in Adolescents With Type 1 Diabetes.,"OBJECTIVE Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count. RESULTS Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count ( r = 0.82, P < 0.001). Factors associated with adherence were age, glycemic control, and country. CONCLUSIONS We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out.",2020,"RESULTS Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","['Adolescents With Type 1 Diabetes', 'adolescents with type 1 diabetes', '443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs']","['placebo', 'Statins and ACE Inhibitors']","['Adherence based on MEMS and pill count', 'Adherence', 'adherence based on MEMS and pill count', 'Median adherence', 'Medication Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",443.0,0.0573073,"RESULTS Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","[{'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Niechciał', 'Affiliation': ''}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': ''}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': ''}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': ''}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': ''}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': ''}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0884'] 246,32311398,"TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial.","TRIAL DESIGN We report results from a phase IIa study of efficacy and safety of PF-06700841, an oral TYK2/Jak1 inhibitor, in patients with moderate-to-severe plaque psoriasis (NCT02969018). METHODS Patients were randomized to PF-06700841 30 mg once daily (QD), 60 mg QD, or placebo (4-week induction), followed by 10 mg QD, 30 mg QD, 100 mg once weekly, or placebo (8-week maintenance). The primary endpoint was week 12 change from baseline in PASI score. Secondary endpoints were the proportion of patients achieving 75% and 90% reduction from baseline PASI at week 12. RESULTS In total, 212 patients in 35 sites were treated; mean (SD) baseline PASI score was 20.8 (7.68). Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups. The greatest change from baseline (least squares mean change -17.3 [95% confidence interval, -20.0 to -14.6]) was observed in the 30-mg QD continuous treatment group. Overall, 136 patients experienced treatment-emergent adverse events, including six serious adverse events in five patients and 13 discontinuations in treatment groups because of adverse events. No herpes zoster cases or major adverse cardiac events including thromboembolic events occurred. CONCLUSIONS PF-06700841 was generally effective and well tolerated in patients with moderate-to-severe plaque psoriasis.",2020,Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups.,"['Patients with Plaque Psoriasis', 'Patients', 'patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis (NCT02969018', '212 patients in 35 sites were treated; mean (SD) baseline PASI score 20.8 (7.68']","['PF-06700841 30 mg once daily (QD), 60 mg QD, or placebo', 'TYK2/JAK1 Inhibitor PF-06700841', 'placebo', 'Placebo']","['effective and well tolerated', 'proportion of patients achieving 75% and 90% reduction from baseline PASI', 'thromboembolic events', 'PASI', '12 change from baseline (CFB) in Psoriasis Area and Severity Index (PASI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C5139802', 'cui_str': 'PF-06700841'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",212.0,0.151263,Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups.,"[{'ForeName': 'Seth B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, Florida, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, Québec, Canada; Laval University, Québec City, Québec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Gilbert', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Kieras', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ruolun', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Dahong', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Papacharalambous', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tehlirian', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts, USA. Electronic address: elena.peeva@pfizer.com.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.03.962'] 247,32311455,"Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal.","OBJECTIVES To quantify the presence of two model highly permeable drugs, paracetamol and danazol, in the upper gastrointestinal lumen under conditions simulating the situation after disintegration of immediate release dosage forms administered in bioavailability/bioequivalence studies in the fed state. To understand the drug transfer process from the antral contents through the upper small intestine based on luminal drug data. METHODS 8 healthy male adult volunteers participated in a randomized, single dose, two-phase, crossover study. After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube. The drugs were administered in solution form (Phase I) and in suspension form (Phase II) with a glass of tap water to the antrum of the stomach, 30 min after the initiation of meal administration. Samples were aspirated from the antrum and the upper small intestine up to 4 hours post drug administration. RESULTS Apparent concentrations in the aqueous contents of the antrum were higher than apparent concentrations in the micellar contents of the upper small intestine for paracetamol; the opposite was observed for danazol. Based on total drug amount per volume data in contents of the upper gastrointestinal lumen, the transfer of paracetamol (aqueous solution or suspension) and danazol (aqueous suspension) through the upper small intestine could be described as an apparent first-order process. Transfer of a long-chain triglyceride solution of danazol was highly variable. CONCLUSIONS Concentrations in the aqueous/micellar phase of luminal contents and values of parameters controlling the transfer from bulk gastric contents through the upper small intestine after a high-calorie, high-fat meal, were reported for the first time for highly permeable drugs. Data are expected to enhance the development of biorelevant in vitro and physiologically based biopharmaceutics modelling methodologies.",2020,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.",['8 healthy male adult volunteers'],"['paracetamol and danazol', 'danazol', 'paracetamol (aqueous solution or suspension) and danazol (aqueous suspension']",[],"[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]",[],8.0,0.0387024,"After evaluating the impact of homogenization on meal's viscosity and particle size, the meal, containing phenol red as non-absorbable marker, was administered to the antrum via the gastric lumen of a naso-gastro-intestinal tube.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105351'] 248,31271885,Effect of Sirolimus on Immune Reconstitution Following Myeloablative Allogeneic Stem Cell Transplantation: An Ancillary Analysis of a Randomized Controlled Trial Comparing Tacrolimus/Sirolimus and Tacrolimus/Methotrexate (Blood and Marrow Transplant Clinical Trials Network/BMT CTN 0402).,"Although allogeneic hematopoietic cell transplantation (HCT) is a potentially curative therapy for hematologic neoplasms, one of its limiting toxicities continues to be graft-versus-host disease, both acute (aGVHD) and chronic (cGVHD). Sirolimus is a mammalian target of rapamycin inhibitor that has proven effective in GVHD prophylaxis in combination with a calcineurin inhibitor, such as tacrolimus. The impact of sirolimus on immune reconstitution has not been comprehensively investigated in vivo thus far, however. Here we present an ancillary analysis of the randomized study BMT-CTN 0402 that examined the effect of sirolimus on immune subsets post-transplantation. We further examine the association between different lymphocyte subsets and outcomes post-transplantation in each arm. BMT-CTN 0402 was a randomized trial (n = 304) comparing 2 GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) and tacrolimus/methotrexate (Tac/MTX), in patients with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome undergoing myeloablative HLA-matched HCT. There were no differences in 114-day GVHD-free survival (primary endpoint), aGVHD, cGVHD, relapse, or overall survival (OS) between the 2 arms. Of the 304 patients, 264 had available samples for the current immune reconstitution analysis. Blood samples were collected at 1, 3, 6, 12, and 24 months post-HCT. Multiparameter flow cytometry was performed at the project laboratory (Esoterix Clinical Trials Services) in a blinded fashion, and results for the 2 arms were compared. Multivariable Cox regression models, treating each phenotypic parameter as a time-dependent variable, were constructed to study the impact of reconstitution on clinical outcomes. There were no significant differences in patient and transplantation characteristics between the Tac/Sir and Tac/MTX arms in this analysis. Absolute lymphocyte count and CD3 + cell, CD4 + cell, and conventional T cell (Tcon) counts were significantly decreased in the Tac/Sir arm for up to 3 months post-HCT, whereas CD8 + cells recovered even more slowly (up to 6 months) in this arm. Interestingly, there was no clear difference in the absolute number of regulatory T cells (Tregs, defined as CD4 + CD25 + cells) between the 2 arms at any point post-HCT; however, the Treg:Tcon ratio was significantly greater in the Tac/Sir arm in the first 3 months after HCT. B lymphocyte recovery was significantly compromised in the Tac/Sir arm from 1 month to 6 months after HCT, whereas natural killer cell reconstitution was not affected in the Tac/Sir arm. In the outcomes analysis, higher numbers of CD3 + cells, CD4 + cells, CD8 + cells, and Tregs were associated with better OS. Neither Treg numbers nor the Treg:Tcon ratio was correlated with GVHD. Our findings indicate that Tac/Sir has a more profound T cell suppressive effect than the combination of Tac/MTX in the early post-transplantation period, and particularly compromises the recovery of CD8 + T cells, which have been implicated in aGVHD. Sirolimus used in vivo with tacrolimus does not appear to result in increased absolute numbers of Tregs, but might have a beneficial effect on the Treg:Tcon balance in the first 3 months after transplantation. Nonetheless, no differences in aGVHD or cGVHD between the 2 arms were observed in the parent randomized trial. Calcineurin-inhibitor free, sirolimus-containing GVHD prophylaxis strategies, incorporating other novel agents, should be investigated further to maximize the potential favorable effect of sirolimus on Treg:Tcon balance in the post-transplantation immune repertoire. Sirolimus significantly compromises B cell recovery in the first 6 months post-HCT, with potential complex effects on cGVHD that merit further study.",2019,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","['myeloablative allogeneic stem-cell transplantation', '264/304 patients had available samples for the current immune reconstitution analysis']","['sirolimus', 'Sirolimus', 'tacrolimus', 'calcineurin inhibitors like tacrolimus', 'rapamycin (mTOR) inhibitor', 'myeloablative HLA-matched transplantation', 'GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) versus tacrolimus/methotrexate (Tac/MTX', 'Tacrolimus/Sirolimus with Tacrolimus/Methotrexate', 'Tac/MTX', 'allogeneic hematopoietic cell transplantation (HCT']","['NK cells reconstitution', 'absolute number of regulatory T-cells', '114-day GVHD free survival', 'Blood samples', 'immune reconstitution', 'compromises B-cell recovery', 'patient and transplant characteristics', 'Absolute lymphocyte count (ALC), CD3+, CD4+ and conventional T cell counts', 'higher numbers of CD3+, CD4', 'aGVHD or cGVHD', 'B-lymphocyte recovery', 'overall survival', 'acute or chronic GVHD, relapse or overall survival']","[{'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0394254,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","[{'ForeName': 'Mahasweta', 'Initials': 'M', 'LastName': 'Gooptu', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mahasweta_gooptu@dfci.harvard.edu.'}, {'ForeName': 'Haesook T', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.06.029'] 249,32311751,Influence of Antagonist Material on Fatigue and Fracture Resistance of Zirconia Crowns.,"OBJECTIVE This study investigates the influence of the most commonly used indenter materials on fatigue survival and fracture resistance of zirconia crowns. MATERIALS AND METHODS A total of 40 zirconia crowns were prepared using computer-aided design (CAD)/computer-aided manufacturing (CAM) technology: 30 crowns were divided into three experimental groups of 10 specimens and the last 10 specimens acted as the control group. The experimental groups were subjected to chewing simulation with simultaneous thermocycling. Three indenter materials (steatite ceramic, stainless steel, and tungsten carbide) with identical diameter were used to load the specimens. All crowns were then subjected to single load to fracture test in universal testing machine. Load was applied vertically with a crosshead speed of 1 mm/min until failure, and fracture load was recorded. STATISTICAL ANALYSIS Normal distribution of data was confirmed using the Shapiro-Wilk test. Descriptive statistics including means and standard deviations were determined for all groups. Differences between groups were tested using Dunnett's test and paired sample t -test. RESULTS Chewing simulation for 1.2 million cycles resulted in 100% survival. The highest mean fracture load was recorded for the control group and the lowest one was for the group fatigued with stainless steel indenter. Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter. However, the mean fracture load for the crowns fatigued with tungsten carbide was not significantly different from that of the control group. CONCLUSION Steatite ceramic and stainless steel indenters produced close results and significantly reduced fracture load of zirconia crowns. However, tungsten carbide indenter caused nonsignificant reduction in the fracture load of zirconia crowns.",2020,Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter.,"['30 crowns', '40 zirconia crowns', 'Zirconia Crowns']","['Antagonist Material', 'computer-aided design (CAD)/computer-aided manufacturing (CAM) technology']","['Fatigue and Fracture Resistance', 'fatigue survival and fracture resistance', 'survival', 'fracture load of zirconia crowns', 'highest mean fracture load', 'mean fracture load']","[{'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}]","[{'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0162516', 'cui_str': 'Computer-Assisted Manufacturing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",30.0,0.0230117,Chewing simulation statistically significantly ( p < 0.05) reduced the mean fracture load of the crowns fatigued with stainless steel and steatite ceramic indenter.,"[{'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Nawafleh', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Abdel Raheem', 'Initials': 'AR', 'LastName': 'Bibars', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Al Twal', 'Affiliation': 'Department of Applied Dental Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Öchsner', 'Affiliation': 'Faculty of Mechanical Engineering, Esslingen University of Applied Sciences, Esslingen, Germany.'}]",European journal of dentistry,['10.1055/s-0040-1708228'] 250,32311845,Changes in respiratory mechanics at birth in preterm infants: A pilot study.,"OBJECTIVE We aimed to measure lung mechanics at birth by the forced oscillation technique (FOT) for assessment of the initial degree of lung aeration and the short-term aeration changes after applying different respiratory support strategies. METHODS Eighteen preterm infants (gestational age = 29-36 week) were randomized to receive either continuous positive airway pressure (CPAP) at 5 cmH 2 O only or combined with a sustained inflation (SI; 15 seconds at 25 cmH 2 O after 5 seconds of CPAP) at birth. We assessed the respiratory system reactance at 5 Hz (X 5; increases with lung volume recruitment at a given distending pressure) at 2, 40, and 150 seconds after initiation of CPAP. k-Means clustering of the initial X 5 value (X 5,i ) stratified newborn into either infants with lower (lowerX 5,i ; X 5  < -280 cmH 2 O*s/L) and higher (higherX 5,i ; X 5  > -240 cmH 2 O*s/L) initial degree of lung volume recruitment. RESULTS Initial values were highly heterogeneous. In the LowerX 5,i group, X 5 increased with time, with SI-patients showing significantly higher values at 150 seconds than the non-SI group (X 5  = -89 ± 27 cmH 2 O vs -274 ± 58 cmH 2 O). In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment. Moreover, 75% of infants receiving SI in the higherX 5,i group experienced a transient loss of aeration after the maneuver. CONCLUSIONS Preterm newborns present initially with highly heterogeneous lung aeration at birth that significantly impacts the effectiveness of the subsequent lung volume recruitment strategy. FOT may represent a valuable tool for individualizing a respiratory resuscitation at birth as it is noninvasive and may be applied simultaneously to respiratory support.",2020,"In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","['Eighteen preterm infants (gestational age\u2009=\u200929-36 week', 'preterm infants']","['continuous positive airway pressure (CPAP) at 5\u2009cmH 2 O only or combined with a sustained inflation (SI; 15\u2009seconds at 25\u2009cmH 2 O after 5\u2009seconds of CPAP', 'FOT', 'forced oscillation technique (FOT']","['respiratory system reactance', 'transient loss of aeration']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",18.0,0.0588961,"In the higherX 5,i group, X 5 did not improve with time, regardless of the respiratory strategy, suggesting a lack of lung recruitment.","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Veneroni', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Mercadante', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lavizzari', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Mariarosa', 'Initials': 'M', 'LastName': 'Colnaghi', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit (NICU), Fondazione IRCCS Ca'Granda Foundation, Ospedale Maggiore Policlinico Hospital-Università degli Studi di Milano, Milan, Italy.""}, {'ForeName': 'Raffaele L', 'Initials': 'RL', 'LastName': 'Dellacà', 'Affiliation': 'TechRes lab, Department of Electronics, Information and bioengineering, Politecnico di Milano University, Milano, Italy.'}]",Pediatric pulmonology,['10.1002/ppul.24772'] 251,31801567,"Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial.","BACKGROUND Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock. METHODS AND DESIGN The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a multicenter, double-blind, adaptive sample size, randomized, placebo-controlled trial designed to test the efficacy of combination therapy with vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) given every 6 h for up to 16 doses in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. The primary outcome is ventilator- and vasopressor-free days with mortality as the key secondary outcome. Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000. The Data and Safety Monitoring Board reviewed interim results at N = 200, 300, 400 and 500, and has recommended continuing recruitment. The next interim analysis will occur when N = 1000. This update presents the statistical analysis plan. Specifically, we provide definitions for key treatment and outcome variables, and for intent-to-treat, per-protocol, and safety analysis datasets. We describe the planned descriptive analyses, the main analysis of the primary end point, our approach to secondary and exploratory analyses, and handling of missing data. Our goal is to provide enough detail that our approach could be replicated by an independent study group, thereby enhancing the transparency of the study. TRIAL REGISTRATION ClinicalTrials.gov, NCT03509350. Registered on 26 April 2018.",2019,"Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000.","['patients with septic shock', 'patients with respiratory or circulatory dysfunction (or both) resulting from sepsis', '501 participants have been enrolled to date, with a planned maximum sample size of 2000']","['vitamin C', 'thiamine', 'placebo', 'Vitamin C, thiamine and hydrocortisone', 'hydrocortisone', 'Vitamin C, Thiamine and Steroids']",['ventilator- and vasopressor-free days with mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",501.0,0.706881,"Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA. chris.lindsell@vumc.org.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nwosu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Pulmonary & Critical Care, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Division of Pulmonary & Critical Care, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'Division of Pulmonary & Critical Care, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alpha A', 'Initials': 'AA', 'LastName': 'Fowler', 'Affiliation': 'Division of Pulmonary Disease & Critical Care Medicine, Department of Internal Medicine, The VCU Johnson Center for Critical Care and Pulmonary Research, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Gaieski', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jeremiah S', 'Initials': 'JS', 'LastName': 'Hinson', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Hooper', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, Department of Medicine, Eastern Virginia Medical School and Sentara Healthcare, Norfolk, VA, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Jackson', 'Affiliation': 'Division of Pulmonary & Critical Care, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Gabor D', 'Initials': 'GD', 'LastName': 'Kelen', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Molecular & Clinical Nutrition Section, Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 10 Center Drive, Bethesda, MD, USA.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Grady Memorial Hospital, Atlanta, GA, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Sevransky', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, Department of Medicine, Emory University, Emory Critical Care Center, Atlanta, GA, USA.'}, {'ForeName': 'Kert', 'Initials': 'K', 'LastName': 'Viele', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Department of Emergency Medicine, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Hager', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, Department of Medicine, Johns Hopkins University, 1800 Orleans Street, Suite 9121, Baltimore, MD, 21287, USA.'}]",Trials,['10.1186/s13063-019-3775-8'] 252,30899994,Abaloparatide effect on forearm bone mineral density and wrist fracture risk in postmenopausal women with osteoporosis.,"PURPOSE Wrist fractures are common, contribute significantly to morbidity in women with postmenopausal osteoporosis, and occur predominantly at the ultradistal radius, a site rich in trabecular bone. This exploratory analysis of the phase 3 ACTIVE study evaluated effects of abaloparatide versus placebo and teriparatide on forearm bone mineral density (BMD) and risk of wrist fracture. METHODS Forearm BMD was measured by dual energy X-ray absorptiometry in a subset of 982 women from ACTIVE, evenly distributed across the three treatment groups. Wrist fractures were ascertained in the total cohort (N = 2463). RESULTS After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001). At 18 months, 1/3 radius BMD losses (versus baseline) were similar for abaloparatide compared with placebo (-0.42; 95% CI -1.03, 0.20; p = 0.19) but losses with teriparatide exceeded those of placebo (-1.66%; 95% CI -2.27, -1.06; p < 0.001). The decline with abaloparatide was less than that seen with teriparatide (group difference 1.22%; 95% CI 0.57, 1.87; p < 0.001). The radius BMD findings, at both ultradistal and 1/3 sites, are consistent with the numerically lower incidence of wrist fractures observed in women treated with abaloparatide compared with teriparatide (HR = 0.43; 95% CI 0.18, 1.03; p = 0.052) and placebo (HR = 0.49, 95% CI 0.20, 1.19, p = 0.11). CONCLUSIONS Compared with teriparatide, abaloparatide increased BMD at the ultradistal radius (primarily trabecular bone) and decreased BMD to a lesser extent at the 1/3 radius (primarily cortical bone), likely contributing to the numerically lower wrist fracture incidence observed with abaloparatide.",2019,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","['982 women from ACTIVE, evenly distributed across the three treatment groups', 'postmenopausal women with osteoporosis', 'women with postmenopausal osteoporosis']","['abaloparatide versus placebo and teriparatide', 'placebo', 'teriparatide']","['Wrist fractures', 'BMD', 'forearm bone mineral density (BMD) and risk of wrist fracture', 'wrist fractures', 'radius BMD losses', 'ultradistal radius BMD changes', 'forearm bone mineral density and wrist fracture risk', 'decline with abaloparatide', 'radius BMD findings']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}]","[{'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna (disorder)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",,0.361972,"After 18 months, ultradistal radius BMD changes from baseline were 2.25 percentage points greater for abaloparatide compared with placebo (95% confidence interval (CI) 1.38, 3.12, p < 0.001) and 1.54 percentage points greater for abaloparatide compared with teriparatide (95% CI 0.64, 2.45, p < 0.001).","[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA. nelson.watts@hotmail.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Lakewood, CO, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04890-2'] 253,31927219,Influencing college students' normative perceptions of protective behavioral strategies: A pilot randomized trial.,"INTRODUCTION Personalized feedback interventions (PFIs) are associated with small but reliable decreases in alcohol consumption among college students. While they often include information regarding protective behavioral strategies (PBS), PFIs do not typically include feedback aimed to modify normative perceptions of PBS. This study aimed to enhance the efficacy of existing PFIs among college students by incorporating normative feedback on participants' use of PBS. METHODS Students enrolled in undergraduate courses (N = 268) completed baseline and 1-month follow-up assessments of past-month use of PBS, normative perceptions of PBS use, alcohol consumption, and alcohol-related consequences. Participants were randomized to one of three conditions: typical feedback on PBS (typical strategies PFI), descriptive normative feedback on PBS (strategy norms PFI), or assessment-only control (AOC). Participants in the typical strategies PFI and strategy norms PFI conditions received web-based personalized feedback profiles. RESULTS Compared to AOC, both the strategy norms PFI and typical strategies PFI were effective in correcting participants' perceptions of other students' engagement in PBS (p = .01) but did not differ significantly from one another. No statistically significant differences were observed between conditions in terms of actual PBS use, alcohol consumption, or alcohol-related consequences at 1-month follow-up (p > .05). DISCUSSION The strategy norms and typical strategies PFIs were both successful in increasing normative perceptions of PBS use, indicating that general (rather than normative) feedback regarding PBS use may be sufficient for changing perceptions of PBS use.",2020,"No statistically significant differences were observed between conditions in terms of actual PBS use, alcohol consumption, or alcohol-related consequences at 1-month follow-up (p > .05). ","['college students', 'Students enrolled in undergraduate courses (N\xa0=\xa0268']","['Personalized feedback interventions (PFIs', 'typical feedback on PBS (typical strategies PFI), descriptive normative feedback on PBS (strategy norms PFI), or assessment-only control (AOC']","['actual PBS use, alcohol consumption, or alcohol-related consequences']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",,0.0309089,"No statistically significant differences were observed between conditions in terms of actual PBS use, alcohol consumption, or alcohol-related consequences at 1-month follow-up (p > .05). ","[{'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, United States.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, United States.'}, {'ForeName': 'Emma I', 'Initials': 'EI', 'LastName': 'Brett', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baraldi', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, United States.'}, {'ForeName': 'Thad R', 'Initials': 'TR', 'LastName': 'Leffingwell', 'Affiliation': 'Department of Psychology, Oklahoma State University, Stillwater, OK, United States. Electronic address: leavens@okstate.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106256'] 254,31769402,Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years.,"The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, redeveloped as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera-induced diarrhea in adult volunteer challenge trials but has not been studied in children in developed countries. We performed a phase 4, placebo-controlled, double-blind, multicenter study to assess the safety, immunogenicity, and tolerability of a single, oral dose of PXVX0200 in children and adolescents aged 6-17 years in the United States and bridged immunogenicity to adults aged 18-45 years from a separate lot consistency study. Volunteers were randomized to receive a single dose of 1 × 10 9 colony forming units (CFU) of PXVX0200 or placebo. Immunogenicity endpoints included SVA levels on days 1, 11, and 29 in volunteers aged 6-17 years and also on days 91 and 181 in volunteers aged 12-17 years. Safety was assessed by comparing solicited signs and symptoms on days 1-8, unsolicited adverse events (AEs) through day 29, and serious AEs through day 181. A total of 374 participants were enrolled, comprising 321 vaccine and 53 placebo recipients. The SVA seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine and placebo recipients, respectively, and the vaccine seroconversion rate was non-inferior to the 93.5% rate seen in adults aged 18-45 years. Most reactogenicity was mild to moderate, and there were no vaccine-related serious AEs. The complete dose was consumed in 95.3% and 98.1% of vaccine and placebo recipients, respectively. PXVX0200 appears safe, immunogenic, and well tolerated in children and adolescents aged 6-17 years.",2020,"The SVA seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine and placebo recipients, respectively, and the vaccine seroconversion rate was non-inferior to the 93.5% rate seen in adults aged 18-45 years.","['children and adolescents aged 6-17 years in the United States and bridged immunogenicity to adults aged 18-45 years from a separate lot consistency study', 'Children and Adolescents', 'Aged 6-17 Years', 'volunteers aged 6-17 years and also on days 91 and 181 in volunteers aged 12-17 years', '374 participants were enrolled, comprising 321 vaccine and 53 placebo recipients', 'children and adolescents aged 6-17 years']","['placebo', 'PXVX0200', 'Live Oral Cholera Vaccine CVD 103-HgR', 'PXVX0200 or placebo']","['vaccine seroconversion rate', 'Safety', 'Safety and Immunogenicity', 'safety, immunogenicity, and tolerability', 'SVA seroconversion rates', 'SVA levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0961644', 'cui_str': 'cholera vaccine CVD 103-HgR'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",374.0,0.6955,"The SVA seroconversion rates 10 days after immunization were 98.6% and 2.1% in vaccine and placebo recipients, respectively, and the vaccine seroconversion rate was non-inferior to the 93.5% rate seen in adults aged 18-45 years.","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McCarty', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Gierman', 'Affiliation': 'PaxVax, Inc., Redwood City, California.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bedell', 'Affiliation': 'PaxVax, Inc., Redwood City, California.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lock', 'Affiliation': 'PaxVax, Inc., Redwood City, California.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Bennett', 'Affiliation': 'PaxVax, Inc., Redwood City, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0241'] 255,32171768,Frequency of Mass Azithromycin Distribution for Ocular Chlamydia in a Trachoma Endemic Region of Ethiopia: A Cluster Randomized Trial.,"PURPOSE Annual mass azithromycin distribution significantly reduces the prevalence of ocular Chlamydia trachomatis, the causative organism of trachoma. However, in some areas a decade or more of treatment has not controlled infection. Here, we compared multiple treatment arms from a community-randomized trial to evaluate whether increasing frequency of azithromycin distribution decreases prevalence in the short term. METHODS Seventy-two communities in Goncha Siso Enesie woreda in the Amhara region of Northern Ethiopia were randomized to 1 of 6 azithromycin distribution strategies: (1) delayed, (2) annual, (3) biannual, (4) quarterly to children only, (5) biennial, or (6) biennial plus latrine promotion. We analyzed data from the 60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit. Communities in the annual and biennial distribution arm were combined, as they each had a single distribution before any 12-month retreatment. We assessed the effect of increased frequency of azithromycin distribution on ocular chlamydia prevalence. RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P < .0001) and adults (P < .0001), with lower prevalence associated with higher frequency. Among children, quarterly azithromycin distribution led to a significantly greater reduction in ocular chlamydia prevalence than the World Health Organization-recommended annual treatment prevalence (mean difference -11.4%, 95% confidence interval -19.5 to -3.3%, P = .007). CONCLUSIONS Increased frequency of azithromycin distribution leads to decreased ocular chlamydia prevalence over a short-term period. In some regions with high levels of ocular chlamydia prevalence, additional azithromycin distributions may help achieve local elimination of infection.",2020,"RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","['Seventy-two communities in Goncha Seso Enesie Woreda in the Amhara Region of Northern Ethiopia', '60 communities in the delayed, annual, biannual, quarterly, and biennial distribution arms at the 12-month study visit', 'ocular chlamydia in a trachoma endemic region of Ethiopia']","['azithromycin', 'azithromycin distribution strategies: 1) delayed, 2) annual, 3) biannual, 4) quarterly to children only, 5) biennial, or 6) biennial plus latrine promotion', 'azithromycin distribution']","['ocular chlamydia prevalence', 'Ocular chlamydia prevalence']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C0243130', 'cui_str': 'endemics'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0495108,"RESULTS Ocular chlamydia prevalence was significantly different across azithromycin distribution frequency in children (P<0.0001) and adults (P<0.0001), with lower prevalence associated with higher frequency.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA. Electronic address: tom.lietman@ucsf.edu.'}, {'ForeName': 'Berhan', 'Initials': 'B', 'LastName': 'Ayele', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Teshome', 'Initials': 'T', 'LastName': 'Gebre', 'Affiliation': 'International Trachoma Initiative, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mulat', 'Initials': 'M', 'LastName': 'Zerihun', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Emerson', 'Affiliation': 'International Trachoma Initiative, Atlanta, Georgia, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Nash', 'Affiliation': 'The Carter Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California, San Francisco, San Francisco, California, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.019'] 256,30977273,"Can acetylcysteine ameliorate cisplatin-induced toxicities and oxidative stress without decreasing antitumor efficacy? A randomized, double-blind, placebo-controlled trial involving patients with head and neck cancer.","The protective antioxidant activity of acetylcysteine (NAC) against toxicity due to cisplatin has been reported in experimental models; however, its efficacy in patients has not been elucidated. The aim of this study was to investigate the possible protective effect of NAC on cisplatin-induced toxicity and the effect of NAC on clinical response and oxidative stress in patients treated for head and neck cancer. This was a randomized, double-blind, placebo-controlled trial conducted in patients receiving high-dose cisplatin chemotherapy concomitant to radiotherapy. Patients were randomly assigned to groups and received: (a) 600 mg NAC syrup, orally once daily at night for 7 consecutive days or (b) placebo, administered similarly to NAC. Nephro-, oto-, hepato-, myelo-, and gastrointestinal toxicities, clinical responses, and plasma and cellular markers of oxidative stress were evaluated. Fifty-seven patients were included (n = 28, NAC arm; and n = 29, placebo arm). A high prevalence of most types of toxicities was observed after cisplatin chemotherapy; however, the parameters were similar between the two groups. There was a predominance of partial response to treatment. In the cellular and plasmatic oxidative stress analyses, minor differences were observed. Overall, there was no statistically significant difference between the groups for all outcomes. These findings show that low-dose oral NAC does not protect patients with head and neck cancer from cisplatin-induced toxicities and oxidative stress. The antitumor efficacy of cisplatin was apparently not impaired by NAC.",2019,"A high prevalence of most types of toxicities was observed after cisplatin chemotherapy; however, the parameters were similar between the two groups.","['patients receiving high-dose cisplatin chemotherapy concomitant to radiotherapy', 'patients with head and neck cancer from', 'Fifty-seven patients were included (n\xa0=\xa028, NAC arm; and n\xa0=\xa029, placebo arm', 'patients treated for head and neck cancer', 'patients with head and neck cancer']","['NAC', 'acetylcysteine (NAC', 'placebo', 'cisplatin']","['clinical response and oxidative stress', 'antitumor efficacy', 'Nephro-, oto-, hepato-, myelo-, and gastrointestinal toxicities, clinical responses, and plasma and cellular markers of oxidative stress', 'toxicities and oxidative stress', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",57.0,0.379367,"A high prevalence of most types of toxicities was observed after cisplatin chemotherapy; however, the parameters were similar between the two groups.","[{'ForeName': 'Marília B', 'Initials': 'MB', 'LastName': 'Visacri', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Júlia C F', 'Initials': 'JCF', 'LastName': 'Quintanilha', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'de Sousa', 'Affiliation': 'Faculty of Pharmaceutical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Laís S', 'Initials': 'LS', 'LastName': 'Amaral', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Rosiane', 'Initials': 'R', 'LastName': 'de F L Ambrósio', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Luciane', 'Initials': 'L', 'LastName': 'Calonga', 'Affiliation': 'Clinical Hospital, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Silvia F B B', 'Initials': 'SFBB', 'LastName': 'Curi', 'Affiliation': 'Clinical Hospital, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mayra F', 'Initials': 'MF', 'LastName': 'de T Leme', 'Affiliation': 'Clinical Hospital, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Carlos T', 'Initials': 'CT', 'LastName': 'Chone', 'Affiliation': 'Clinical Hospital, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'João M C', 'Initials': 'JMC', 'LastName': 'Altemani', 'Affiliation': 'Clinical Hospital, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Priscila G', 'Initials': 'PG', 'LastName': 'Mazzola', 'Affiliation': 'Faculty of Pharmaceutical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Malaguti', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Aníbal E', 'Initials': 'AE', 'LastName': 'Vercesi', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Carmen S P', 'Initials': 'CSP', 'LastName': 'Lima', 'Affiliation': 'School of Medical Sciences, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Moriel', 'Affiliation': 'Faculty of Pharmaceutical Sciences, University of Campinas, Campinas, Brazil.'}]",Cancer medicine,['10.1002/cam4.2072'] 257,30911782,Use of antiosteoporotic medication in the Danish ROSE population-based screening study.,"Use of antiosteoporotic medication in the population-based, risk-stratified osteoporosis strategy evaluation (ROSE) screening study, comparing the use of FRAX followed by DXA with usual care, was examined. Screening increased the overall use of medication. Being recommended treatment by the hospital and higher age increased the likelihood of starting medication, but, nevertheless, a large percentage opted not to start treatment. INTRODUCTION The aim of the study was to examine the impact on medication prescription, adherence, and persistence of osteoporotic medicine in the randomized population-based ROSE screening study for osteoporosis. METHODS The Danish ROSE study included a population-based random sample of women aged 65-81 years randomized to either a two-step screening program consisting of FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care). This sub-study on the intention-to-treat population examined the impact of the screening program on antiosteoporotic medication redemption rates, adherence, and persistence using Danish registers. RESULTS A total of 30,719 of 34,229 women were treatment-naïve. Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found. Higher age was associated with a higher likelihood of starting medication. A low Charlson comorbidity score (= 1) was associated with higher treatment initiation but lower adherence and persistence of antiosteoporotic treatment. A total of 31.7% of participants advised to initiate treatment did not follow the advice. CONCLUSIONS Screening for osteoporosis using FRAX followed by DXA increased the overall use of antiosteoporotic medication in the screening group without differences in adherence and persistence rates. A large percentage of participants advised to initiate treatment did nevertheless fail to do so.",2019,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","['Danish ROSE study included a population-based random sample of women aged 65-81\xa0years', 'A total of 30,719 of 34,229 women were treatment-naïve']","['antiosteoporotic medication', 'FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care', 'FRAX']","['antiosteoporotic medication', 'adherence and persistence rates', 'overall use of medication']","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0422389', 'cui_str': 'Opportunistic screening (procedure)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",34229.0,0.0382527,"Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Høiberg', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark. mikkelhoiberg@gmail.com.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Rubin', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Holmberg', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rothmann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN - Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gram', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bech', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brixen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Hermann', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-04934-7'] 258,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS. METHODS Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors. RESULTS Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039). CONCLUSIONS Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3'] 259,31159584,Facilitators and barriers affecting PrEP adherence among Thai men who have sex with men (MSM) in the HPTN 067/ADAPT Study.,"The HPTN 067/ADAPT Study evaluated the feasibility, acceptability, patterns of adherence and coverage for three randomly assigned oral FTC/TDF pre-exposure prophylaxis (PrEP) dosing regimens to prevent HIV infection. Using qualitative methods, we explored facilitators and barriers among a subset of men who have sex with men (MSM) participants in Bangkok, Thailand. Between August 2013 and March 2014, 32 HPTN 067/ADAPT participants joined in 6 focus group discussions, and 6 attended key informant interviews. Facilitators of PrEP adherence included use of strategies to have PrEP available when needed, simplicity in regimen requirements with recognition that more complex regimens may take some time to master, ability to plan for sex, receipt of social and technology support, ability to use a PrEP regimen that best matches to one's own patterns of sex, and experiences with PrEP as a part of health and well-being. Challenges to PrEP adherence included perceptions of no or low HIV risk, difficulties following regimens when intoxicated, concerns about side effects, experience of HIV stigma, and affordability of PrEP outside of study context influencing uptake and use in the community. Preferences for regimens varied, suggesting that multiple PrEP effective regimen options should be available to fit those with different needs.",2020,"adherence included perceptions of no or low HIV risk, difficulties following regimens when intoxicated, concerns about side effects, experience of HIV stigma, and affordability of PrEP outside of study context influencing uptake and use in the community.","['Between August 2013 and March 2014, 32 HPTN 067/ADAPT', 'Thai men who have sex with men (MSM) in the HPTN 067/ADAPT', 'men who have sex with men (MSM) participants in Bangkok, Thailand']","['PrEP', 'FTC/TDF pre-exposure prophylaxis (PrEP', 'HPTN 067/ADAPT']","['side effects, experience of HIV stigma, and affordability of PrEP outside of study context influencing uptake and use in the community', 'feasibility, acceptability, patterns of adherence and coverage']","[{'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0814630', 'cui_str': 'Affordabilities'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",3.0,0.0434697,"adherence included perceptions of no or low HIV risk, difficulties following regimens when intoxicated, concerns about side effects, experience of HIV stigma, and affordability of PrEP outside of study context influencing uptake and use in the community.","[{'ForeName': 'Tareerat', 'Initials': 'T', 'LastName': 'Chemnasiri', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Anchalee', 'Initials': 'A', 'LastName': 'Varangrat', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Chitwarakorn', 'Affiliation': 'Silom Community Clinic @TropMed, Bangkok, Thailand.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Dye', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'Gladstone Institutes, University of California, San\xa0Francisco, CA, USA.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Holtz', 'Affiliation': 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS care,['10.1080/09540121.2019.1623374'] 260,30968588,"Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies.","AIM To assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles. METHODS Two randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated. RESULTS In Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P < 0.05), no emesis (all P < 0.05), and NSN (delayed phase P < 0.05 cycles 1, 2, and 4) reported across 4 cycles. In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients. CONCLUSION Oral NEPA was highly effective in preventing both acute and delayed CINV over multiple chemotherapy cycles of HEC, AC, and MEC regimens. CLINICAL TRIAL REGISTRATION NUMBERS Study 1, NCT01339260; Study 2, NCT01376297.",2019,"In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients. ","['chemotherapy-naive patients receiving', 'patients receiving multiple cycles of chemotherapy', '1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles']","['anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy', 'oral NEPA (netupitant-palonosetron', 'oral palonosetron 0.50\xa0mg (Study 1) or oral aprepitant 125', 'Oral dexamethasone', 'Oral NEPA', 'oral NEPA']","['nausea and vomiting', 'no emesis', 'nausea and vomiting (CINV', 'CR and NSN rates', 'Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates', 'NSN']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.0782679,"In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients. ","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Memphis, Tennessee.'}, {'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Karthaus', 'Affiliation': 'Staedt. Klinikum Neuperlach and Harlaching, Munich, Germany.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Borroni', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California San Francisco Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': 'Department of Medicine V, Hematology, Oncology and Rheumatology, University of Heidelberg, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Hansen', 'Affiliation': 'Northern Utah Associates, Ogden, Utah.'}]",Cancer medicine,['10.1002/cam4.2091'] 261,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma. METHODS It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months. RESULTS In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months. CONCLUSION The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001'] 262,30565338,"Attribute level overlap (and color coding) can reduce task complexity, improve choice consistency, and decrease the dropout rate in discrete choice experiments.","A randomized controlled discrete choice experiment (DCE) with 3,320 participating respondents was used to investigate the individual and combined impact of level overlap and color coding on task complexity, choice consistency, survey satisfaction scores, and dropout rates. The systematic differences between the study arms allowed for a direct comparison of dropout rates and cognitive debriefing scores and accommodated the quantitative comparison of respondents' choice consistency using a heteroskedastic mixed logit model. Our results indicate that the introduction of level overlap made it significantly easier for respondents to identify the differences and choose between the choice options. As a stand-alone design strategy, attribute level overlap reduced the dropout rate by 30%, increased the level of choice consistency by 30%, and avoided learning effects in the initial choice tasks of the DCE. The combination of level overlap and color coding was even more effective: It reduced the dropout rate by 40% to 50% and increased the level of choice consistency by more than 60%. Hence, we can recommend attribute level overlap, with color coding to amplify its impact, as a standard design strategy in DCEs.",2019,The combination of level overlap and color coding was even more effective: It reduced the dropout rate by 40% to 50% and increased the level of choice consistency by more than 60%.,"['3,320 participating respondents']",[],"['dropout rate', 'level of choice consistency']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",,0.0254765,The combination of level overlap and color coding was even more effective: It reduced the dropout rate by 40% to 50% and increased the level of choice consistency by more than 60%.,"[{'ForeName': 'Marcel F', 'Initials': 'MF', 'LastName': 'Jonker', 'Affiliation': 'Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Donkers', 'Affiliation': 'Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'de Bekker-Grob', 'Affiliation': 'Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Elly A', 'Initials': 'EA', 'LastName': 'Stolk', 'Affiliation': 'Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, The Netherlands.'}]",Health economics,['10.1002/hec.3846'] 263,31231780,Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women.,"A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9-14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9-17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9-14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.",2020,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"['Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses', 'girls receiving 3 or 2 doses was noninferior compared with that in young adult women', 'girls vs. 3 doses in young women', 'Girls aged 9-14 years', 'December 2015 in China', 'adult women']","['Escherichia coli-produced HPV bivalent vaccine', 'HPV vaccine']","['IgG geometric mean concentration (GMC) ratio', 'GMC ratio of IgG', 'neutralizing antibodies']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",,0.320641,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"[{'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Wen-Gang', 'Initials': 'WG', 'LastName': 'He', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Jian-Xiang', 'Initials': 'JX', 'LastName': 'Gu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'BiZhen', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Xing-Mei', 'Initials': 'XM', 'LastName': 'Yao', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ya-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'FeiXue', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. zhangj@xmu.edu.cn.'}, {'ForeName': 'Ning-Shao', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. nsxia@xmu.edu.cn.'}]",Science China. Life sciences,['10.1007/s11427-019-9547-7'] 264,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer. METHODS This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression. RESULTS Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. CONCLUSIONS Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8'] 265,32310298,The clinical impact of a multiplex real-time PCR system for microbiological diagnosis of sepsis: a mortality study.,"To evaluate the impact of the use of a multiplex-real time PCR-based assay (SeptiFast M-Grade®) on in-hospital mortality in ICU sepsis patients. Demographic, clinical and microbiological data from ICU patients with suspected sepsis and available SeptiFast (SF) test results were gathered. The intervention group comprised patients in which SF indicated a clinical intervention; the non-intervention group included patients in whom SF result did not lead to any clinical intervention. The study looked at expected and observed in-hospital mortality rates in both intervention and non-intervention groups. Two-hundred and fifty-five patients (121 patients in the intervention group and 134 patients in the non-intervention group) were included in the study. When comparing both groups, we found no significant differences in severity scores, either in estimated or observed mortalities. Older age, high APACHE II scores, and infections caused by Gram-negative pathogens and carbapenem-resistant enterobacteria were all associated with a higher risk of death in both groups. Overall, blood cultures and SF agreed in 75.3% of cases. Positivity rates were 22.0% for blood culture, 29.4% for SF, and 38.0% combined. Though we did not find a correlation between SeptiFast-based intervention and changes in in-hospital mortality, SeptiFast improved positivity rates. The above improvement in microbiological diagnosis might be associated with fewer complications, lower hospitalization costs and presumably better long-term survival rates in sepsis patients.",2020,"Positivity rates were 22.0% for blood culture, 29.4% for SF, and 38.0% combined.","['Two-hundred and fifty-five patients (121 patients in the intervention group and 134 patients in the non-intervention group) were included in the study', 'ICU sepsis patients', 'microbiological diagnosis of sepsis', 'ICU patients with suspected sepsis and available SeptiFast (SF) test results were gathered']","['clinical intervention; the non-intervention group included patients in whom SF result did not lead to any clinical intervention', 'multiplex-real time PCR-based assay (SeptiFast MGrade ®', 'multiplex real-time PCR system']","['hospital mortality rates', 'severity scores', 'Overall, blood cultures and SF', 'inhospital mortality, SeptiFast improved positivity rates', 'hospitalization costs', 'Positivity rates']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",255.0,0.0430301,"Positivity rates were 22.0% for blood culture, 29.4% for SF, and 38.0% combined.","[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Grijalva', 'Affiliation': 'Departamento de Ciencias de la Vida, Universidad de las Fuerzas Armadas ESPE, Sangolquí, Ecuador.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'De La Torre', 'Affiliation': 'Departamento de Laboratorio Clínico, Colegio de Ciencias Médicas, Universidad Estatal del Sur de Manabí, Jipijapa, Ecuador.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Sánchez', 'Affiliation': 'Unidad de Laboratorio Clínico, Hospital de Especialidades Eugenio Espejo, Quito, Ecuador.'}]",The new microbiologica,[] 266,31930781,Interventions to slow progression of myopia in children.,"BACKGROUND Nearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents. OBJECTIVES To assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children. SEARCH METHODS We searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019. SELECTION CRITERIA We included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than -0.25 diopters (D) spherical equivalent myopia. DATA COLLECTION AND ANALYSIS We followed standard Cochrane methods. MAIN RESULTS We included 41 studies (6772 participants). Twenty-one studies contributed data to at least one meta-analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias. Spectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average -0.15 D (95% confidence interval [CI] -0.29 to 0.00; n = 142; low-certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI -0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low-certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate-certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (-0.06 mm, 95% CI -0.09 to -0.04; n = 896; moderate-certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low-certainty evidence). Contact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI -0.06 to 0.47; n = 300; low-certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD -0.11 mm, 95% CI -0.14 to -0.08; n = 300; low-certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI -0.05 to 0.10; n = 415; very low-certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low-certainty evidence). Pharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate-certainty evidence). Axial elongation was less for children treated with atropine (MD -0.35 mm, 95% CI -0.38 to -0.31; n = 502) and pirenzepine (MD -0.13 mm, 95% CI -0.14 to -0.12; n = 326) than for those treated with placebo (moderate-certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low-certainty evidence) but did not report axial length. Systemic 7-methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI -0.09 to 0.24) nor on axial elongation (MD -0.03 mm, 95% CI -0.10 to 0.03) compared with placebo in one study (n = 77; moderate-certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD -0.05 D, 95% CI -0.21 to 0.11; n = 95; low-certainty evidence). Combinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate-certainty evidence). One study reported -0.37 mm (95% CI -0.47 to -0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate-certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate-certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate-certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results. No serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate-certainty evidence). AUTHORS' CONCLUSIONS Antimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low-certainty evidence to support RGPCLs and sperical aberration SCLs.",2020,"Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence).","['children 18 years or younger', 'children', 'Spectacle lenses', 'myopia in children', 'participants had less than -0.25 diopters (D) spherical equivalent myopia', 'participants were older than 18 years at baseline', '41 studies (6772 participants']","['SVLs plus timolol', 'Orthokeratology contact lenses', 'placebo: MD', 'interventions', 'timolol', 'rigid gas permeable contact lenses (RGPCLs', 'placebo', 'placebo plus SVLs', 'atropine', 'cyclopentolate plus SVLs', 'pirenzepine gel', 'tropicamide', 'cyclopentolate eye drops']","['refractive error and axial length outcomes', 'slowing axial elongation', 'serious adverse events', 'Axial elongation', 'slowed myopia progression', 'experience accommodation difficulties', 'myopia progression nor in axial length', 'myopia progression', 'myopic progression', 'axial length', 'spectacles, contact lenses, pharmaceutical agents, and combination treatments', 'axial elongation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0444946', 'cui_str': 'Gas permeable (qualifier value)'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0031978', 'cui_str': 'Pirenzepine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}]","[{'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0152198', 'cui_str': 'Disorder of accommodation (disorder)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.514633,"Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence).","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University, College of Optometry, 338 West Tenth Avenue, Columbus, Ohio, USA, 43210-1240.'}, {'ForeName': 'Kristina B', 'Initials': 'KB', 'LastName': 'Lindsley', 'Affiliation': 'IBM Watson Health, Life Sciences, Oncology, & Genomics, Baltimore, Maryland, USA.'}, {'ForeName': 'S Swaroop', 'Initials': 'SS', 'LastName': 'Vedula', 'Affiliation': 'Johns Hopkins University, 3400 N. Charles Street, Baltimore, Maryland, USA, 21218.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry, 2575 Yorba Linda Boulevard, Fullerton, California, USA, 92831.'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Mutti', 'Affiliation': 'The Ohio State University, College of Optometry, 338 West Tenth Avenue, Columbus, Ohio, USA, 43210-1240.'}, {'ForeName': 'Sueko M', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, 615 N. Wolfe Street, W5010, c/o Cochrane Eyes and Vision Group, Baltimore, Maryland, USA, 21205.'}, {'ForeName': 'J Daniel', 'Initials': 'JD', 'LastName': 'Twelker', 'Affiliation': 'University of Arizona, Department of Ophthalmology, 655 North Alvernon Way Suite 108, Tucson, Arizona, USA, 85711.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004916.pub4'] 267,32067096,"Ultra-high-fidelity virtual reality mastoidectomy simulation training: a randomized, controlled trial.","PURPOSE Ultra-high-fidelity (UHF) graphics in virtual reality (VR) simulation might improve surgical skill acquisition in temporal bone training. This study aims to compare UHF VR simulation training with conventional, screen-based VR simulation training (cVR) with respect to performance and cognitive load (CL). METHODS In a randomized trial with a cross-over design, 24 students completed a total of four mastoidectomies in a VR temporal bone surgical simulator: two performances under UHF conditions using a digital microscope and two performances under conventional conditions using screen-based VR simulation. Performances were assessed by two blinded raters using an established assessment tool. In addition, CL was estimated as the relative change in secondary-task reaction time during simulation when compared with individual baseline measurements. Data were analyzed using linear mixed model analysis for repeated measurements. RESULTS The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR simulation [mean difference 1.0 points out of 17 points, 95% CI (0.2-1.7), p = 0.02]. The most important factor for performance during UHF simulation was the ability to achieve stereovision (mean difference = 3.4 points, p < 0.001). Under the UHF VR condition, CL was significantly higher than during cVR (28% vs. 18%, respectively, p < 0.001). CONCLUSION UHF graphics in VR simulation training reduced performance and induced a higher CL in novices than conventional, screen-based VR simulation training. Consequently, UHF VR simulation training should be preceded by cVR training and might be better suited for the training of intermediates or experienced surgeons.",2020,The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR ,['24 students completed a total of four mastoidectomies\xa0in a VR temporal bone surgical simulator: two performances under UHF conditions using a'],"['UHF VR simulation training with conventional, screen-based VR simulation training (cVR', 'digital microscope and two performances under conventional conditions using screen-based VR simulation', 'UHF graphics', 'cVR', 'Ultra-high-fidelity (UHF) graphics in virtual reality (VR) simulation', 'UHF VR simulation training', 'Ultra-high-fidelity virtual reality mastoidectomy simulation training']",['mean final-product performance score'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}, {'cui': 'C0039484', 'cui_str': 'Temporal Bone'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0181839', 'cui_str': 'Microscope, device (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0683758,The mean final-product performance score was significantly lower in UHF VR simulation compared to cVR ,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Frithioff', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark. Andreasfrit@hotmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frendø', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Peter Trier', 'Initials': 'PT', 'LastName': 'Mikkelsen', 'Affiliation': 'The Alexandra Institute, Aarhus, Denmark.'}, {'ForeName': 'Mads Sølvsten', 'Initials': 'MS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Steven Arild Wuyts', 'Initials': 'SAW', 'LastName': 'Andersen', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Rigshospitalet, HovedOrtoCentret, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05858-3'] 268,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y'] 269,31834117,Sleep-Wake States and Feeding Progression in Preterm Infants.,"BACKGROUND Previous studies demonstrated a short-term relationship between infant sleep-wake states and oral feeding performance, with state being an indication of infants' neurobehavioral readiness for feeding. However, the relationship between sleep-wake states and feeding skills has not been evaluated longitudinally during hospitalization. OBJECTIVES The purpose of this study was to examine preterm infants' sleep-wake state developmental trajectories and their associations with feeding progression during hospitalization. METHODS This descriptive and exploratory study was a secondary analysis using data from a longitudinal two-group, randomized controlled trial evaluating the effects of early and late cycled light on health and developmental outcomes among extremely preterm infants who were born ≤28 weeks of gestational age. Sleep-wake states were assessed for two 2-hour interfeeding periods per day (day and night hours), 30 weeks postmenstrual age, and every 3 weeks until discharge. Occurrences of active sleep, quiet sleep, and waking were recorded every 10 seconds. Feeding progression was assessed based on an infant's postmenstrual age at five milestones: first enteral feeding, full enteral feeding, first oral feeding, half oral feeding, and full oral feeding. Trajectory analyses were used to describe developmental changes in sleep-wake states, feeding progression patterns, and associations between feeding progression and sleep-wake trajectories. RESULTS Active sleep decreased while waking, and quiet sleep increased during hospitalization. Two distinct feeding groups were identified: typical and delayed feeding progression. In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression. We also found that infants with delayed feeding progression were more likely to be awake more often during the night compared to infants with typical feeding progression. DISCUSSIONS Findings suggest that delays in sleep-wake state development may be associated with delays in feeding progression during hospitalization. Infants with delayed feeding skill development may require more environmental protection to further support their sleep development.",2020,"In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression.","['extremely preterm infants who were born ≤28 weeks of gestational age', 'Preterm Infants', 'preterm infants']",['early and late cycled light'],"['health and developmental outcomes', 'Sleep-wake states', 'Feeding progression', 'Active sleep decreased while waking, and quiet sleep', 'sleep-wake state developmental trajectories', 'Occurrences of active sleep, quiet sleep, and waking', 'sleep-wake states, feeding progression patterns, and associations between feeding progression and sleep-wake trajectories', 'Sleep-Wake States and Feeding Progression', 'rates of active and quiet sleep development']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",,0.0231115,"In infants with delayed feeding progression, rates of active and quiet sleep development during the day were delayed compared to those with typical feeding progression.","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Jinhee Park, PhD, RN, is Assistant Professor, School of Nursing, Boston College, Chestnut Hill, Massachusetts. Susan G. Silva, PhD, is Associate Professor, School of Nursing, Duke University, Durham, North Carolina. Suzanne M. Thoyre, PhD, RN, FANN, is Professor, School of Nursing, University of North Carolina at Chapel Hill. Debra H. Brandon, PhD, RN, CNS, FAAN, is Associate Professor, School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Thoyre', 'Affiliation': ''}, {'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Brandon', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000395'] 270,29292264,[Protective effect of dexmedetomidine against perioperative inflammation and on pulmonary function in patients undergoing radical resection of lung cancer].,"OBJECTIVE To study the protective effect of dexmedetomidine against perioperative inflammation and on pulmonary function in patients undergoing radical resection of lung cancer. METHODS From May, 2014 to May, 2016, 124 patients with lung cancer receiving radical surgeries were randomized into experimental group (n=62) and control group (n=62). The patients in the control group received a single anesthetic agent for anesthesia, and additional dexmedetomidine was given in the experimental group. The levels of serum interleukin-1β (IL-1β), IL-10, and tumor necrosis factor-alpha (TNF-α) were measured before the operation (T 0 ), at 30 min (T 1 ) and 60 min (T 2 ) during one lung ventilation (OLV) and at the end of operation (T 3 ). Enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of malondialdehyde (MDA), myeloperoxidase (MPO) and xanthine oxidase (XOD), and the arterial oxygen partial pressure (PaO 2 ), oxygenation index (OI), airway plateau pressure (APP) and airway resistance (AR) were also recorded. RESULTS At the time points of T 1 and T 2 , IL-1β, IL-10, MDA, MPO, TNF-α, and XOD levels were significantly increased in both of the groups, but the levels of IL-1, IL-10, TNF-α and MDA were significantly lower and MPO and XOD levels significantly higher in the experimental group than in the control group (P<0.05). In both groups, PaO 2 and OI decreased and APP and AR increased significantly at T 1 and T 2 , but APP and AR were significantly lower and PaO 2 and OI significantly higher in the experimental group than in the control group (P<0.05). CONCLUSION Anesthesia with dexmedetomidine in lung cancer patients undergoing radical surgery can effectively reduce the inflammatory response of the lungs and protect the lung function of the patients.",2017,Anesthesia with dexmedetomidine in lung cancer patients undergoing radical surgery can effectively reduce the inflammatory response of the lungs and protect the lung function of the patients.,"['patients undergoing radical resection of lung cancer', 'lung cancer patients undergoing', '124 patients with lung cancer receiving radical surgeries']","['radical surgery', 'dexmedetomidine', 'Enzyme-linked immunosorbent assay (ELISA', 'single anesthetic agent for anesthesia, and additional dexmedetomidine']","['pulmonary function', 'MPO and XOD levels', 'PaO 2 and OI decreased and APP and AR', 'levels of serum interleukin-1β (IL-1β), IL-10, and tumor necrosis factor-alpha (TNF-α', 'levels of IL-1, IL-10, TNF-α and MDA', 'levels of malondialdehyde (MDA), myeloperoxidase (MPO) and xanthine oxidase (XOD), and the arterial oxygen partial pressure (PaO 2 ), oxygenation index (OI), airway plateau pressure (APP) and airway resistance (AR', 'APP and AR', 'IL-1β, IL-10, MDA, MPO, TNF-α, and XOD levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0912079', 'cui_str': 'myelopoietin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0043317', 'cui_str': 'Hypoxanthine Dehydrogenase'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index'}, {'cui': 'C3697386', 'cui_str': 'Airway plateau pressure (observable entity)'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}]",124.0,0.0212891,Anesthesia with dexmedetomidine in lung cancer patients undergoing radical surgery can effectively reduce the inflammatory response of the lungs and protect the lung function of the patients.,"[{'ForeName': 'Yuan-Bo', 'Initials': 'YB', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Guangdong General Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China. E-mail: fengly_1314@sina.com.'}, {'ForeName': 'Jin-Dong', 'Initials': 'JD', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xue-Xia', 'Initials': 'XX', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Jian-Xing', 'Initials': 'JX', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jie-Xian', 'Initials': 'JX', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Zhou', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 271,32305492,Probiotics and fructo-oligosaccharide intervention modulate the microbiota-gut brain axis to improve autism spectrum reducing also the hyper-serotonergic state and the dopamine metabolism disorder.,"The prevalence of autism spectrum disorders (ASD) is increasing, but its etiology remains elusive and hence an effective treatment is not available. Previous research conducted on animal models suggests that microbiota-gut-brain axis may contribute to ASD pathology and more human research is needed. This study was divided into two stages,.At the discovery stage, we compared the differences in gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters (using UHPLC-MS/MS) of 26 children with ASD and 24 normal children. All 26 children with ASD participated in the intervention stage, and we measured the gut microbiota profiles, SCFAs and neurotransmitters before and after probiotics + FOS (n = 16) or placebo supplementation (n = 10). We found that gut microbiota was in a state of dysbiosis and significantly lower levels of Bifidobacteriales and Bifidobacterium longum were observed at the discovery stage in children with ASD. An increase in beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium) emerged after probiotics + FOS intervention, with significant reduction in the severity of autism and gastrointestinal symptoms. Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD. Interestingly, the above SCFAs in children with autism significantly elevated after probiotics + FOS intervention and approached those in the control group. In addition, our data demonstrated that decreased serotonin and increased homovanillic acid emerged after probiotics + FOS intervention. However, the above-mentioned changes did not appear in the placebo group for ASD children. Probiotics + FOS intervention can modulate gut microbiota, SCFAs and serotonin in association with improved ASD symptoms, including a hyper-serotonergic state and dopamine metabolism disorder.",2020,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","['26 children with ASD', '26 children with ASD and 24 normal children', 'autism', 'autism spectrum disorders (ASD', 'children with ASD']","['Probiotics and fructo-oligosaccharide intervention', 'placebo supplementation', 'Probiotics\u2009+\u2009FOS intervention', 'placebo']","['gut microbiota profiles (using 16S rRNA sequencing), fecal SCFAs (using GC-MS) and plasma neurotransmitters', 'hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid', 'severity of autism and gastrointestinal symptoms', 'acetic acid, propionic acid and butyric acid', 'homovanillic acid', 'beneficial bacteria (Bifidobacteriales and B. longum) and suppression of suspected pathogenic bacteria (Clostridium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0087140', 'cui_str': 'v-fos Oncogenes'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0024868', 'cui_str': 'Chromatography, Gas-Mass Spectrometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019903', 'cui_str': 'Homovanillic acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1037103', 'cui_str': 'Bifidobacteriales'}, {'cui': 'C1564227', 'cui_str': 'Longum'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",26.0,0.0229384,"Compared to children in the control group, significantly lower levels of acetic acid, propionic acid and butyric acid were found, and a hyperserotonergic state (increased serotonin) and dopamine metabolism disorder (decreased homovanillic acid) were observed in children with ASD.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China; State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: wangyingying67@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 754520623@qq.com.""}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'College of Life Science, Qilu Normal University, Jinan, Shandong, China. Electronic address: microbiota@foxmail.com.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Zhao', 'Affiliation': ""Institute of Child Health Care, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: jnzhaodongmei@163.com.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China. Electronic address: binchen23@163.com.""}, {'ForeName': 'Guo-Qing', 'Initials': 'GQ', 'LastName': 'Zhang', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: gqzhang@picb.ac.cn.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China; CAS Key Laboratory of Quantitative Engineering Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, Guangdong, China. Electronic address: shuo.chen1@siat.ac.cn.'}, {'ForeName': 'Rui-Fang', 'Initials': 'RF', 'LastName': 'Cao', 'Affiliation': 'Bio-Med Big Data Center, CAS Key Laboratory of Computational Biology, CAS-MPG Partner Institute for Computational Biology, Shanghai Institute of Nutrition and Health, Shanghai, China. Electronic address: caoruifang@picb.ac.cn.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: yuhan_1991@163.com.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1163310981@qq.com.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1295163749@qq.com.""}, {'ForeName': 'Yong-Sheng', 'Initials': 'YS', 'LastName': 'Ge', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: 1305358934@qq.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: liuyi-ly@126.com.""}, {'ForeName': 'Le-Hai', 'Initials': 'LH', 'LastName': 'Zhang', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: zlh6813@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Microbial Technology, Shandong University, Qingdao, Shandong, China. Electronic address: hw_1@sdu.edu.cn.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine and Engineering, Beihang University, Key Laboratory of Big Data-Based Precision Medicine (Beihang University), the Ministry of Industry and Information Technology of the People's Republic of China, Beijing, China; Microbiome Research Center, Shandong Institutes for Food and Drug Control, Shandong Institute of Industrial Technology for Health Sciences and Precision Medicine, Jinan, Shandong, China. Electronic address: microbiome@foxmail.com.""}, {'ForeName': 'Zhong-Tao', 'Initials': 'ZT', 'LastName': 'Gai', 'Affiliation': ""Shandong Children's Microbiome Center, Research Institute of Pediatrics, Qilu Children's Hospital of Shandong University, Jinan, Shandong, China. Electronic address: gzt@etyy.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.104784'] 272,31204129,Single-dose cardioplegia protects myocardium as well as traditional repetitive dosing: A noninferiority randomized study.,"OBJECTIVE The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.",2020,"There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23).","['110 patients', 'From October 2012 to May 2014']","['preoperative electrocardiogram and determination of creatine kinase-MB, troponin', 'Custodiol histidine-tryptophan-ketoglutarate', 'single-dose Custodiol histidine-tryptophan-ketoglutarate', 'repetitive cold-blood cardioplegia', 'Custodiol histidine-tryptophan-ketoglutarate cardioplegia']","['safety and efficacy', 'cardiac biomarkers release', 'cardiopulmonary bypass time (102\xa0±', 'death or myocardial infarction', 'intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels', 'Left ventricular function', 'aortic crossclamp time', 'Postoperative cardiac biomarkers']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0005768'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",110.0,0.115447,"There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vivacqua', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich. Electronic address: Alessandro.Vivacqua@beaumont.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Mich.'}, {'ForeName': 'Amr E', 'Initials': 'AE', 'LastName': 'Abbas', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Altshuler', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Francis L', 'Initials': 'FL', 'LastName': 'Shannon', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Podolsky', 'Affiliation': 'Beaumont Research Institute, Royal Oak, Mich.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Sakwa', 'Affiliation': 'Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.03.125'] 273,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8'] 274,32247073,Sitagliptin attenuates the progression of coronary atherosclerosis in patients with coronary disease and type 2 diabetes.,"BACKGROUND AND AIMS Type 2 diabetes mellitus (T2DM) is a well-recognized independent risk factor for ASCVD, the aim of this study was to investigate the effects of a dipeptidyl peptidase-4 inhibitor, sitagliptin, on prevention of progression of coronary atherosclerosis assessed by three-dimensional quantitative coronary angiography (3D-QCA) in T2DM patients with coronary artery disease (CAD). METHODS This was a prospective, randomized, double-center, open-label, blinded end point, controlled 18-month study in patients with CAD and T2DM. A total of 149 patients, who had at least 1 atherosclerotic plaque with 20%-80% luminal narrowing in a coronary artery, and had not undergone intervention during a clinically indicated coronary angiography or percutaneous coronary intervention, were randomized to sitagliptin group (n = 74) or control group (n = 75). Atherosclerosis progression was measured by repeat 3D-QCA examination in 88 patients at study completion. The primary outcome was changes in percent atheroma volume (PAV) from baseline to study completion measured by 3D-QCA. Secondary outcomes included change in 3D-QCA-derived total atheroma volume (TAV) and late lumen loss (LLL). RESULTS The primary outcome of PAV increased of 1.69% (95%CL, -0.8%-4.2%) with sitagliptin and 5.12% (95%CL, 3.49%-6.74%) with the conventional treatment (p = 0.023). The secondary outcome of change in TAV in patients treated with sitagliptin increased of 6.45 mm 3 (95%CL,-2.46 to 6.36 mm 3 ) and 9.45 mm 3 (95%CL,-4.52 to 10.14 mm 3 ) with conventional treatment (p = 0.023), however, no significant difference between groups was observed (p = 0.175). Patients treated with sitagliptin had similar LLL as compared with conventional antidiabetics (-0.06, 95%CL, -0.22 to 0.03 vs. -0.08, -0.23 to -0.03 mm, p = 0.689). CONCLUSIONS In patients with type 2 diabetes and coronary artery disease, treatment with sitagliptin resulted in a significantly lower rate of progression of coronary atherosclerosis compared with conventional treatment.",2020,"Patients treated with sitagliptin had similar LLL as compared with conventional antidiabetics (-0.06, 95%CL, -0.22 to 0.03 vs. -0.08, -0.23 to -0.03 mm, p = 0.689). ","['149 patients, who had at least 1 atherosclerotic plaque with 20%-80% luminal narrowing in a coronary artery, and had not undergone intervention during a clinically indicated coronary angiography or percutaneous coronary intervention', '88 patients at study completion', 'patients with type 2 diabetes and coronary artery disease', 'T2DM patients with coronary artery disease (CAD', 'patients with coronary disease and type 2 diabetes', 'patients with CAD and T2DM']","['sitagliptin', 'Sitagliptin']","['Atherosclerosis progression', 'change in TAV', 'sitagliptin', 'change in 3D-QCA-derived total atheroma volume (TAV) and late lumen loss (LLL', 'PAV', 'percent atheroma volume (PAV', 'rate of progression of coronary atherosclerosis', 'progression of coronary atherosclerosis']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C4705836', 'cui_str': '7-((2,5-dioxopyrrolidin-1-yl)methyl)-4-(2-fluoro-4-(11C)methoxyphenyl) quinoline-2-carboxamide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0264956', 'cui_str': 'Atheroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1261077', 'cui_str': 'Structure of lower lobe of left lung'}, {'cui': 'C0058890', 'cui_str': 'EAP protocol'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",149.0,0.104108,"Patients treated with sitagliptin had similar LLL as compared with conventional antidiabetics (-0.06, 95%CL, -0.22 to 0.03 vs. -0.08, -0.23 to -0.03 mm, p = 0.689). ","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Chinese Hainan Hospital of PLA General Hospital, Sanya, Hainan Province, China.'}, {'ForeName': 'Yan-Rong', 'Initials': 'YR', 'LastName': 'Luo', 'Affiliation': 'Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yun-Dai', 'Initials': 'YD', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China. Electronic address: cyundai@vip.163.com.'}, {'ForeName': 'Jin-Wen', 'Initials': 'JW', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, Chinese Hainan Hospital of PLA General Hospital, Sanya, Hainan Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Ying-Qian', 'Initials': 'YQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Fukang Hospital of T.C.M, Fukang, Xinjiang Province, China.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.03.015'] 275,32095843,Effect of prilocaine and its combination with tramadol on anxiety and pain during nasal packing removal.,"PURPOSE To investigate the effect of local usage of prilocaine and ıts combination with tramadol on the pain and anxiety levels of patients during nasal packing removal. METHODS A total of 117 patients who were treated with the Merocel nasal packing after septoplasty were included in the study. Patients whose Merocel nasal packings infiltrated with prilocaine (P group), prilocaine combined with tramadol 1 mg/kg (P + T1 group), prilocaine combined with tramadol 2 mg/kg (P + T2 group), or normal saline solution (Control group) before nasal packing removal were compared for their pain, sedation, and anxiety related to this removal procedure. The visual analog scale (VAS), Ramsay sedation scale (RSS), and State-Trait Anxiety Inventory (STAI) scale were assessed to evaluate the pain, sedation, and anxiety levels of the patients. RESULTS Groups were found similar according to sex, age, and preoperative STAI scores. The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively). However, state anxiety inventory (STAI-S) and RSS were found significantly improved only in P + T1 and P + T2 (STAI-S: p = 0.032, RSS: p = 0.002, STAI-S: p = 0.000, RSS: p < 0.001, respectively). In the comparison of P + T1 and P + T2, no significant difference was found in VAS, RSS, and STAI-S (p = 0.604, p = 0.154, and p = 0.264, respectively). CONCLUSION The combined infiltration of prilocaine and tramadol 1 mg/kg into the nasal packing is effective in reducing the pain and anxiety of patients during nasal packing removal.",2020,"The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively).","['patients during nasal packing removal', '117 patients who were treated with the Merocel nasal packing after septoplasty were included in the study']","['prilocaine combined with tramadol 2\xa0mg/kg (P\u2009+\u2009T2 group), or normal saline solution (Control group) before nasal packing removal', 'prilocaine combined with tramadol', 'prilocaine', 'prilocaine and tramadol', 'tramadol']","['VAS score', 'pain and anxiety levels', 'state anxiety inventory (STAI-S) and RSS', 'pain, sedation, and anxiety levels of the patients', 'anxiety and pain', 'visual analog scale (VAS), Ramsay sedation scale (RSS), and State-Trait Anxiety Inventory (STAI) scale', 'VAS, RSS, and STAI-S ', 'pain and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0222045'}]",117.0,0.0296082,"The VAS score was significantly lower in P, P + T1, and P + T2 than control group during nasal packing removal (p < 0.001, p < 0.001, and p < 0.001, respectively).","[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey. ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey.'}, {'ForeName': 'Rıza Gokcer', 'Initials': 'RG', 'LastName': 'Tulaci', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Departments of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balıkesir University Health Practice and Research Hospital, Cagis, 10440, Balikesir, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05863-6'] 276,31411082,Effect of Blood Pressure Control on Long-Term Risk of End-Stage Renal Disease and Death Among Subgroups of Patients With Chronic Kidney Disease.,"Background Our objective was to explore the effect of intensive blood pressure (BP) control on kidney and death outcomes among subgroups of patients with chronic kidney disease divided by baseline proteinuria, glomerular filtration rate, age, and body mass index. Methods and Results We included 840 MDRD (Modification of Diet in Renal Disease) trial and 1067 AASK (African American Study of Kidney Disease and Hypertension) participants. We used Cox models to examine whether the association between intensive BP control and risk of end-stage renal disease (ESRD) or death is modified by baseline proteinuria (≥0.44 versus <0.44 g/g), glomerular filtration rate (≥30 versus <30 mL/min per 1.73 m 2 ), age (≥40 versus <40 years), or body mass index (≥30 versus <30 kg/m 2 ). The median follow-up was 14.9 years. Strict (versus usual) BP control was protective against ESRD (hazard ratio [HR] ESRD , 0.77; 95% CI, 0.64-0.92) among those with proteinuria ≥0.44 g/g but not proteinuria <0.44 g/g. Strict (versus usual) BP control was protective against death (HR death , 0.73; 95% CI, 0.59-0.92) among those with glomerular filtration rate <30 mL/min per 1.73 m 2 but not glomerular filtration rate ≥30 mL/min per 1.73 m 2 (HR death , 0.98; 95% CI, 0.84-1.15). Strict (versus usual) BP control was protective against ESRD among those ≥40 years (HR ESRD , 0.82; 95% CI, 0.71-0.94) but not <40 years. Strict (versus usual) BP control was also protective against ESRD among those with body mass index ≥30 kg/m 2 (HR ESRD , 0.75; 95% CI, 0.61-0.92) but not body mass index <30 kg/m 2 . Conclusions The ESRD and all-cause mortality benefits of intensive BP lowering may not be uniform across all subgroups of patients with chronic kidney disease. But intensive BP lowering was not associated with increased risk of ESRD or death among any subgroups that we examined.",2019,"BP control was protective against death (HR death , 0.73","['840 MDRD (Modification of Diet in Renal Disease) trial and 1067 AASK (African American Study of Kidney Disease and Hypertension) participants', 'Subgroups of Patients With Chronic\xa0Kidney Disease', 'patients with chronic kidney disease', 'subgroups of patients with chronic kidney disease divided by baseline proteinuria, glomerular filtration rate, age, and body mass index']","['intensive blood pressure (BP) control', 'Blood Pressure Control']","['protective against ESRD (hazard ratio [HR', 'protective against death (HR death', 'glomerular filtration rate', 'glomerular filtration rate ≥30', 'intensive BP control and risk of end-stage renal disease (ESRD) or death', 'Long-Term Risk of End-Stage Renal Disease and Death', 'risk of ESRD or death']","[{'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C3839656', 'cui_str': 'Modification of diet in renal disease formula'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",840.0,0.143448,"BP control was protective against death (HR death , 0.73","[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ku', 'Affiliation': 'Division of Nephrology Department of Medicine University of California San Francisco San Francisco, CA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology Department of Medicine Tufts University Boston Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics University of California, San Francisco San Francisco CA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics University of California, San Francisco San Francisco CA.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Smogorzewski', 'Affiliation': 'Division of Nephrology and Hypertension Department of Medicine University of Southern California Los Angeles CA.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology Department of Medicine University of California San Francisco San Francisco, CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012749'] 277,31705526,"Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS).","BACKGROUND Guselkumab, a fully human interleukin-23 antibody, is approved for systemic treatment of patients with moderate-to-severe plaque psoriasis. OBJECTIVES To compare the efficacy and safety of guselkumab with those of fumaric acid esters (FAE) in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment. METHODS Eligible patients were randomized to this multicentre, randomized, open-label, assessor-blinded, active-comparator-controlled phase IIIb study to receive guselkumab 100 mg by subcutaneous injection or oral FAE according to local label guidelines. RESULTS Through week 24, 56 of 60 patients completed guselkumab treatment and 36 of 59 completed FAE treatment. The primary endpoint (proportion of patients with ≥ 90% improvement from their baseline Psoriasis Area and Severity Index; PASI 90 response) was achieved by significantly more patients receiving guselkumab than FAE at week 24 (82% vs. 14%, P < 0·001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0·001) and Dermatology Life Quality Index score of 0 or 1 (no effect at all on the patient's quality of life; 62% vs. 17%, P < 0·001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0·001). The incidence of adverse events was lower with guselkumab than with FAE (73% vs. 98%). Overall, 28% of patients on FAE discontinued due to an adverse event, compared with none receiving guselkumab. No new safety findings were observed for guselkumab. CONCLUSIONS Guselkumab demonstrated superiority over FAE in systemic-treatment-naive patients with moderate-to-severe plaque psoriasis through 24 weeks.",2019,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","['Eligible patients', 'patients with moderate-to-severe plaque psoriasis', 'systemic treatment-naïve patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis who are naïve to systemic treatment']","['FAE treatment', 'fumaric acid esters', 'Guselkumab', 'oral FAE', 'guselkumab with fumaric acid esters (FAE', 'guselkumab treatment', 'FAE']","['completely clear skin (PASI 100 response', 'PASI 75 response', 'incidence of adverse events (AE', 'baseline Psoriasis Area and Severity Index; PASI\xa090 response', 'Dermatology Life Quality Index (DLQI) response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",,0.088747,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Centre for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Hospital of Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Dermatological Practice Dr. med. Michael Sebastian, Mahlow, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Termeer', 'Affiliation': 'Dermatological Practice Prof. Dr. med. Christian Termeer, Stuttgart, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, University Hospital of Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, Venerology and Allergology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wegner', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krampe', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bartz', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rausch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mensch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eyerich', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18696'] 278,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study. METHODS Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10 CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal. RESULTS Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. CONCLUSION Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. ","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. ","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2'] 279,32307251,"Pasireotide administration after pancreaticoduodenectomy may decrease clinically relevant postoperative pancreatic fistula in high-risk patients with small pancreatic ducts, soft pancreatic parenchyma and cystic or neuroendocrine neoplasia.","OBJECTIVES Post-operative pancreatic fistula (POPF) is a feared complication after a pancreaticoduodenectomy. Previously in a randomized trial found fewer clinically relevant fistulas (CR-POPF) accompanying administration of perioperative pasireotide. Our hospital previously found that the risk for CR-POPF reached 7% in pancreaticoduodenectomy patients. Here, we aimed to determine the CR-POPF rate accompanying prophylactic pasireotide in patients with a normal pancreas at resection level. METHODS In this clinical study, perioperative pasireotide was administered to pancreaticoduodenectomy patients treated between 1 July 2014 and 30 April 2016. High-risk individuals were defined preoperatively by the surgeon based on the following: no dilatation of the pancreatic duct, suspected soft pancreas and a cystic or neuroendocrine tumor at the head of the pancreas. If the pancreas was considered hard at surgery, thereby carrying a lower risk for fistula, pasireotide was discontinued following one preoperative 900-μg dose. Among high-risk patients, pasireotide was continued for one week or until discharge from the hospital. RESULTS During the study period, 153/215 pancreatic operations were pancreaticoduodenectomies, 58 (38%) of which were considered high risk for developing clinically significant pancreatic fistula. Among these, 4 (2.6%) developed a grade B or C fistula: 2 in the pasireotide group [3.5%, 95% confidence interval (CI) 0.4-11.9%], 1 in the low-risk group (1.2%, 95% CI 0.0-6.4%; difference: 2.3%, 95% CI -6.4-17.3%) and 1 in the discontinued group (10%). CONCLUSION We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.",2020,We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.,"['high-risk patients', 'patients treated between 1 July 2014 and 30 April 2016', 'high-risk patients with small pancreatic ducts, soft pancreatic parenchyma and cystic or neuroendocrine neoplasia', 'patients with a normal pancreas at resection level']","['pancreaticoduodenectomy', 'Pasireotide administration after pancreaticoduodenectomy']","['rates of CR-POPF', 'grade B or C fistula', 'CR-POPF rate accompanying prophylactic pasireotide', 'CR-POPF']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]",,0.105048,We found similar rates of CR-POPF among high- and low-risk patients undergoing pancreaticoduodenectomy when using prophylactic perioperative pasireotide in high-risk patients.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vuorela', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: tiina.a.vuorela@hus.fi.'}, {'ForeName': 'Mustonen', 'Initials': 'M', 'LastName': 'Harri', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kokkola', 'Initials': 'K', 'LastName': 'Arto', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Haglund', 'Initials': 'H', 'LastName': 'Caj', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Seppänen', 'Initials': 'S', 'LastName': 'Hanna', 'Affiliation': 'Department of Surgery, Translational Cancer Medicine Research Program, Faculty of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.03.010'] 280,32307307,Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan.,"BACKGROUND Globally, the use of single DTaP-IPV/Hib vaccines that combine DTaP-IPV and Hib is widespread, but in Japan vaccination is usually concomitant at separate sites. The immunogenicity and safety of a primary vaccination series and booster of a combined pentavalent DTaP-IPV/Hib vaccine were evaluated and compared to separate administration of DTaP-IPV and Hib in Japanese infants. METHODS Healthy Japanese infants were administered DTaP-IPV/Hib (Group A: N = 207) or DTaP-IPV + Hib (Group B: N = 207) by the subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route (Group C: N = 10). All subjects received a 3-dose primary vaccination series and a booster. Non-inferiority (Group A versus Group B) was tested post-primary series and subsequent post hoc analyses were performed for anti-Hib. Safety was assessed by parental reports. RESULTS Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 μg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 μg/mL, and for pre-booster antibody persistence and the booster response using 0.15 μg/mL and 1.0 μg/mL. The immune response was similar for each antigen following SC or IM administration. There were no safety concerns in any group, and a lower incidence of injection sites for the IM route was observed as expected. CONCLUSIONS These data show the good immunogenicity and safety profile of the DTaP-IPV/Hib vaccine as a 3-dose infant primary series followed by a booster in the second year of life in Japan.",2020,"RESULTS Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 μg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 μg/mL, and for pre-booster antibody persistence and the booster response using 0.15 μg/","['healthy infants and toddlers in Japan', 'Japanese infants', 'Healthy Japanese infants were administered']","['DTaP-IPV\xa0+\xa0Hib', 'DTaP-IPV/Hib pentavalent vaccine', 'combined pentavalent DTaP-IPV/Hib vaccine', 'subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route', 'DTaP-IPV/Hib (Group A']","['immune response', 'Immunogenicity and safety', 'antibody responses', 'immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0018482', 'cui_str': 'Haemophilus infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0062086', 'cui_str': 'Haemophilus influenzae Type b vaccine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1556154', 'cui_str': 'Intramuscular route'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",207.0,0.0313691,"RESULTS Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 μg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 μg/mL, and for pre-booster antibody persistence and the booster response using 0.15 μg/","[{'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Kitasato Institute for Life Sciences, Tokyo, Japan.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vidor', 'Affiliation': 'Sanofi Pasteur, Lyon, France.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Tsuzuki', 'Affiliation': 'Sanofi, Tokyo, Japan. Electronic address: Daisuke.Tsuzuki@sanofi.com.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nishina', 'Affiliation': 'Sanofi, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Sanofi, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Sanofi, Tokyo, Japan.'}, {'ForeName': 'Hideya', 'Initials': 'H', 'LastName': 'Mizukami', 'Affiliation': 'Sanofi, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuge', 'Affiliation': 'Daiichi Sankyo, Tokyo, Japan.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2019.11.012'] 281,30956109,A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men.,"BACKGROUND Hypersexual disorder (HD) is defined as a condition in which the individual loses control over engagement in sexual behaviors, leading to distress and negative effects on key life areas. Cognitive behavioral therapy (CBT) has been proven to reduce symptoms of hypersexual behavior; however, no randomized controlled study of CBT interventions for HD has been reported previously. AIM To investigate the efficacy of group-administered CBT for HD. METHODS Male participants (n = 137) diagnosed with HD, were randomized between 7 weeks of group-administered CBT (n = 70) and a waitlist control receiving the intervention after 8 weeks (n = 67). Measurements were administered at pre-, mid-, and posttreatment, with follow-up after 3 and 6 months. OUTCOMES The primary outcome was the Hypersexual Disorder: Current Assessment Scale (HD:CAS), and secondary outcomes were the Sexual Compulsivity Scale (SCS) and measures of depression (Montgomery-Åsberg Depression Rating Scale (MADRS-S), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), and treatment satisfaction (CSQ-8). RESULTS A significantly greater decrease in HD symptoms and sexual compulsivity, as well as significantly greater improvements in psychiatric well-being, were found for the treatment condition compared with the waitlist. These effects remained stable at 3 and 6 months after treatment. CLINICAL IMPLICATIONS CBT can ameliorate HD symptoms and psychiatric distress, suggesting that the CBT program may serve as a first-line treatment in clinical settings. STRENGTHS & LIMITATIONS This is the first randomized controlled study evaluating the efficacy of a CBT program in a rather large sample of HD-specific diagnosed men. The long-term treatment effects are vague due to the low response rate on follow-up measurements, and the efficacy of this program for hypersexual women remains unknown. CONCLUSION This study supports the efficacy of a group-administered CBT program as a treatment option for HD; however, future studies should include women, comprise dismantling analysis of the constituting interventions, and evaluate other treatment formats, for example, administration via the Internet. Hallberg J, Kaldo V, Arver S, et al. A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men. J Sex Med 2019;16:733-745.",2019,"A significantly greater decrease in HD symptoms and sexual compulsivity, as well as significantly greater improvements in psychiatric well-being, were found for the treatment condition compared with the waitlist.","['Male participants (n\xa0= 137) diagnosed with HD', 'HD-specific diagnosed men', 'Hypersexual Disorder in Men']","['waitlist control receiving the intervention', 'Group-Administered Cognitive Behavioral Therapy', 'CBT', 'CBT program', 'CBT for HD', 'Cognitive behavioral therapy (CBT']","['Current Assessment Scale (HD:CAS', 'Hypersexual Disorder', 'Sexual Compulsivity Scale (SCS) and measures of depression (Montgomery-Åsberg Depression Rating Scale (MADRS-S), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), and treatment satisfaction (CSQ-8', 'HD symptoms and sexual compulsivity', 'Hallberg J, Kaldo V, Arver S, et']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0502483,"A significantly greater decrease in HD symptoms and sexual compulsivity, as well as significantly greater improvements in psychiatric well-being, were found for the treatment condition compared with the waitlist.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hallberg', 'Affiliation': 'Department of Medicine, Karolinska Institute, Stockholm, Sweden; ANOVA, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute and Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Psychology, Faculty of Health and Life Sciences, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine, Karolinska Institute, Stockholm, Sweden; ANOVA, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Department of Medicine, Karolinska Institute, Stockholm, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute and Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute and Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Katarina Görts', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Department of Medicine, Karolinska Institute, Stockholm, Sweden; ANOVA, Karolinska University Hospital, Stockholm, Sweden. Electronic address: katarina.gorts-oberg@sll.se.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.03.005'] 282,31055726,End-expiratory lung volume decreases during REM sleep despite continuous positive airway pressure.,"PURPOSE Patients with obstructive sleep apnea (OSA) may experience apneas and hypopneas primarily during stage R (REM) sleep when end-expiratory lung volume (EELV) reaches its nadir. The purpose of this study was to determine if REM-related reductions in EELV persist in the presence of continuous positive airway pressure (CPAP) prescribed during non-stage REM (NREM) sleep. METHODS We prospectively recruited 17 subjects referred to the sleep laboratory for CPAP titration. CPAP was titrated per AASM protocol to control respiratory events. The change in EELV was measured using magnetometry. RESULTS Of the 17 subjects, 12 (71%) had moderate to severe OSA. Despite the application of CPAP, there was a significant reduction in EELV between NREM and REM sleep (- 105.9 ± 92.2 to - 325.0 ± 113.1 mL, respectively, p < 0.01). The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01). CONCLUSION REM-related reductions in EELV are associated with worsening sleep disordered breathing and occur despite the presence of CPAP.",2020,"The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01). ","['17 subjects referred to the sleep laboratory for CPAP titration', 'Patients with obstructive sleep apnea (OSA']",['CPAP'],"['EELV between NREM and REM sleep', 'prescribed level of CPAP', 'change in EELV', 'moderate to severe OSA', 'overall apnea-hypopnea index (AHI', 'number of respiratory arousals']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}]",17.0,0.0298988,"The change in EELV between non-stage R (NREM) and REM significantly correlated with overall apnea-hypopnea index (AHI) (r = 0.5, p = 0.04), the number of respiratory arousals during REM (r = 0.5, p = 0.04), and prescribed level of CPAP (r = 0.7, p < 0.01). ","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Koo', 'Affiliation': 'Baroness Erlanger Hospital, Respiratory, Critical Care, and Sleep Medicine, University of Tennessee College of Medicine Chattanooga, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA. drpkoo@gmail.com.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Gartman', 'Affiliation': 'Providence VA Medical Center, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jigme M', 'Initials': 'JM', 'LastName': 'Sethi', 'Affiliation': 'Baroness Erlanger Hospital, Respiratory, Critical Care, and Sleep Medicine, University of Tennessee College of Medicine Chattanooga, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA.'}, {'ForeName': 'F Dennis', 'Initials': 'FD', 'LastName': 'McCool', 'Affiliation': 'Rhode Island Hospital, Alpert Medical School of Brown University, Providence, RI, USA.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01857-9'] 283,32147873,Application of inter-professional care model in patients with aneurysmal subarachnoid haemorrhage.,"OBJECTIVE To explore the feasibility and effect of the inter-professional care model in patients with aneurysmal subarachnoid haemorrhage. METHODS A convenient sampling method was used to recruit inpatients of a hospital as subjects from July 2016 to July 2018. According to the even/odd attribute of admission number, subjects were divided into a control group and an observation group. The number of recruited subjects was 311: the control group comprised 135 participants and the observation group 176. The average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing were compared between the two groups. SPIRIT checklist was completed (see File S1). RESULTS After intervention, patients in the observation group had shorter average hospital stay (15.98 ± 2.7), lower hospital fees (81,018 ± 1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living, and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < .05). CONCLUSION The application of inter-professional care model in single disease patients with aneurysmal subarachnoid haemorrhage can shorten the average hospital stay, reduce hospital fees, improve the quality of life of patients, and increase patients' satisfaction with the quality of nursing, which is worthy of clinical promotion and application. IMPLICATIONS FOR NURSING MANAGEMENT SECTION Nursing managers can use this model to improve the ability to ensure coordination between medical professionals and integrate the ability of nursing problems, the ability to make rational distribution of nursing human resources, and the ability of critical thinking. It can be used as reference to improve the nursing management of all kinds of single diseases.",2020,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05). ","['patients with aneurysmal subarachnoid hemorrhage', 'single disease patients with aneurysmal subarachnoid hemorrhage', 'recruit inpatients of a hospital as subjects from July 2016 to July 2018', '176']",['observation group'],"['incidence of complications', 'lower hospital fees', 'ability to perform activities of daily living , and lower rate of disease outcome and re-admission', 'average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing', 'shorter average hospital stay', 'higher satisfaction with the quality of nursing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0158111,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05). ","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Graduate School of Shanxi, University of Traditional Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}]",Journal of nursing management,['10.1111/jonm.12993'] 284,31356274,Simple Versus Complex Preoperative Carbohydrate Drink to Preserve Perioperative Insulin Sensitivity in Laparoscopic Colectomy: A Randomized Controlled Trial.,,2020,"Postoperative insulin sensitivity was maintained, with no differences in hepatic insulin resistance (HOMA2-IR) or fasting blood glucose on POD 1 to 3.","['30 nondiabetic adult patients undergoing', 'Laparoscopic Colectomy']","['simple CHO drink (400\u200amL containing 50 gr of fructose) or a complex CHO drink (400\u200amL containing 40 gr of maltodextrin and 10 gr of fructose', 'preoperative simple CHO drink', 'laparoscopic colon resection', 'Simple Versus Complex Preoperative Carbohydrate Drink', 'preoperative containing complex carbohydrate (CHO']","['postoperative hepatic insulin resistance assessed by Homeostatic model assessment (HOMA2-IR), fasting blood glucose (FBG), and C-reactive protein (CRP) at baseline and postoperative day (POD 1-3), 30-day complications, and hospital length of stay (LOS', 'perioperative insulin sensitivity', 'complications or LOS', 'complex CHO drink [mean (SD', 'hepatic insulin resistance (HOMA2-IR) or fasting blood glucose', 'Intraoperative insulin sensitivity', 'Postoperative insulin sensitivity', 'intraoperative insulin sensitivity assessed by peripheral glucose uptake (M value']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate (substance)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.133548,"Postoperative insulin sensitivity was maintained, with no differences in hepatic insulin resistance (HOMA2-IR) or fasting blood glucose on POD 1 to 3.","[{'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Karimian', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Pepa', 'Initials': 'P', 'LastName': 'Kaneva', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Donatelli', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Liane S', 'Initials': 'LS', 'LastName': 'Feldman', 'Affiliation': 'Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada.'}]",Annals of surgery,['10.1097/SLA.0000000000003488'] 285,32205206,Soft tissue augmentation around dental implants with connective tissue graft (CTG) and xenogenic collagen matrix (XCM). 1-year randomized control trail.,"BACKGROUND The anatomy of soft tissues around dental implants is extremely important to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Various methods and materials for increasing the physiological thickness of tissues have been described including connective tissue graft (CTG) and xenogenic collagen matrix (XCM). While assessing various materials it is necessary to establish objective measurement method to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant. The aim of the study was to determine the effect of soft tissues in the implant area on the marginal bone level in the implant area and to define of the critical gingival thickness to minimize marginal bone level (MBL) loss. METHODS 75 bone level implants (Conelog® Camlog, Switzerland) were inserted in the aesthetic area. Thickening of soft tissues was performed using CTG and XCM. 12 months after the loading with final restoration, the thickness of soft tissues in the implant area was examined with ultrasound USG device (Pirop®, Echoson, Poland), and each implant was subjected to RVG examination, where MBL loss was determined. RESULTS A tendency to occur less MBL loss was found when thicker gingiva was present. The higher soft tissue thickness was, the lower MBL loss has occurred. A critical value for tissue thickness was determined as TKT ≤ 2.88. CONCLUSIONS In case of thin biotype soft tissue augmentation is required when value of tissue thickness in ultrasound measure is less than 2.88 mm.",2020,A tendency to occur less MBL loss was found when thicker gingiva was present.,"['75 bone level implants (Conelog® Camlog, Switzerland) were inserted in the aesthetic area']",['connective tissue graft (CTG) and xenogenic collagen matrix (XCM'],"['MBL loss', 'Thickening of soft tissues', 'higher soft tissue thickness', 'thickness of soft tissues', 'tissue thickness']","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",75.0,0.0300898,A tendency to occur less MBL loss was found when thicker gingiva was present.,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Puzio', 'Affiliation': 'Dental Surgery Department, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, ul. Krakowska 26, 50-425 Wroclaw, 50413 Wroclaw, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Hadzik', 'Affiliation': 'Dental Surgery Department, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, ul. Krakowska 26, 50-425 Wroclaw, 50413 Wroclaw, Poland. Electronic address: jakub.hadzik@umed.wroc.pl.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Błaszczyszyn', 'Affiliation': 'Dental Surgery Department, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, ul. Krakowska 26, 50-425 Wroclaw, 50413 Wroclaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Gedrange', 'Affiliation': 'Dental Surgery Department, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, ul. Krakowska 26, 50-425 Wroclaw, 50413 Wroclaw, Poland.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Dominiak', 'Affiliation': 'Dental Surgery Department, Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu, ul. Krakowska 26, 50-425 Wroclaw, 50413 Wroclaw, Poland.'}]",Annals of anatomy = Anatomischer Anzeiger : official organ of the Anatomische Gesellschaft,['10.1016/j.aanat.2020.151484'] 286,31034856,A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma: The COMPARE Study.,"PURPOSE To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN Prospective, multicenter, randomized clinical trial. PARTICIPANTS One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded. INTERVENTION Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events. RESULTS Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines. CONCLUSION Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.",2020,"At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004).","['Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded', 'open-angle glaucoma (OAG', 'One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications', 'Open-Angle Glaucoma']","['standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA', 'microinvasive glaucoma surgery (MIGS) devices', 'Hydrus and iStent Microinvasive Glaucoma Surgery Implants']","['IOP and medications', 'complete surgical success', 'rate of complete surgical success', 'BCVA loss of ≥2 lines', 'frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events', 'surgical success rate', 'intraocular pressure (IOP) and medications']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0149893', 'cui_str': 'Secondary glaucoma (disorder)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1706188', 'cui_str': 'Glaucoma surgery specialty'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0857353', 'cui_str': 'Hypotensive'}]","[{'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor (qualifier value)'}, {'cui': 'C1706188', 'cui_str': 'Glaucoma surgery specialty'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",152.0,0.212078,"At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004).","[{'ForeName': 'Iqbal Ike K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fea', 'Affiliation': ""Dipartimento di Scienze Chirurgiche, Universita' di Torino, Torino, Italy.""}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Au', 'Affiliation': 'Manchester Royal Eye Hospital, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Ang', 'Affiliation': 'Asian Eye Institute, Makati City, Philippines.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harasymowycz', 'Affiliation': 'University of Montreal, Bellevue Ophthalmology Clinic, Montreal, Canada.'}, {'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Jampel', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Samuelson', 'Affiliation': 'Minnesota Eye Consultants, Minneapolis, Minnesota.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Chang', 'Affiliation': 'Altos Eye Physicians, Los Altos, California.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rhee', 'Affiliation': 'University Hospitals, Case Western Reserve University, Cleveland, Ohio. Electronic address: dougrhee@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.04.034'] 287,2572699,Use of auditory evoked responses as a measure of recovery from benzodiazepine sedation.,The amplitude of the P300 component of auditory evoked responses was found to be depressed by benzodiazepine sedation and was subsequently used to monitor the recovery of volunteers sedated with midazolam. The amplitude of the evoked responses was found to be highly correlated with blood midazolam levels but to be no more sensitive than standard psychomotor testing in assessing recovery from sedation.,1989,The amplitude of the P300 component of auditory evoked responses was found to be depressed by benzodiazepine sedation and was subsequently used to monitor the recovery of volunteers sedated with midazolam.,[],"['midazolam', 'benzodiazepine sedation']",[],[],"[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",[],,0.0156287,The amplitude of the P300 component of auditory evoked responses was found to be depressed by benzodiazepine sedation and was subsequently used to monitor the recovery of volunteers sedated with midazolam.,"[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Milligan', 'Affiliation': ""Department of Anaesthetics, Queen's University, Belfast.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lumsden', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Howe', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Dundee', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 288,31895273,Randomized Crossover Trial Evaluating the Impact of Senofilcon A Photochromic Lens on Driving Performance.,"SIGNIFICANCE The first contact lens to incorporate a photochromic additive was cleared by the U.S. Food and Drug Administration last year. Because any ophthalmic lens that absorbs visible wavelengths will reduce retinal illuminance, it is important to understand the impact of this new photochromic contact lens on vision and both daytime and nighttime driving performance. PURPOSE The purpose of this study was to evaluate the effect of senofilcon A photochromic contact lens wear on vision and driving performance under real-world conditions by comparison with a nonphotochromic contact lens and plano photochromic spectacles. METHODS In this randomized four-visit bilateral crossover study, 24 licensed regular drivers and established wearers of soft contact lenses were enrolled. Subjects wore in random order each of three study lens types: the investigational photochromic soft contact lens (test), a nonphotochromic soft contact lens (control 1), and plano photochromic spectacle lenses (control 2). Driver performance was assessed on a closed-circuit driving track under challenging controlled conditions. The primary endpoint was overall driving performance score calculated as a composite Z score of six objective metrics. RESULTS All 24 subjects (mean age, 29.8 years) completed the study. For nighttime driving, the adjusted mean differences in Z score (95% confidence interval) between test and control 1 and between test and control 2 were 0.069 (-0.045 to +0.183) and 0.117 (0.003 to 0.231), respectively. For daytime driving, mean differences were 0.101 (-0.013 to +0.216) between test and control 1 and 0.044 (-0.070 to +0.158) between test and control 2. Results demonstrated noninferiority of the test lens relative to controls for nighttime and daytime driving performance using a noninferiority margin of -0.25 Z score. Noninferiority was also demonstrated on all logMAR and contrast threshold testing. No adverse events were reported during the study. CONCLUSIONS Study results revealed no evidence of concerns with either driving performance or vision while wearing photochromic contact lenses.",2020,Results demonstrated noninferiority of the test lens relative to controls for nighttime and daytime driving performance using a noninferiority margin of -0.25 Z score.,"['24 licensed regular drivers and established wearers of soft contact lenses were enrolled', 'All 24 subjects (mean age, 29.8 years) completed the study']","['senofilcon A photochromic contact lens', 'investigational photochromic soft contact lens (test), a nonphotochromic soft contact lens (control 1), and plano photochromic spectacle lenses (control 2', 'Senofilcon A Photochromic Lens']","['Driver performance', 'overall driving performance score', 'Z score', 'Driving Performance', 'adverse events', 'nighttime and daytime driving performance']","[{'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}]",24.0,0.0354802,Results demonstrated noninferiority of the test lens relative to controls for nighttime and daytime driving performance using a noninferiority margin of -0.25 Z score.,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Buch', 'Affiliation': ''}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Toubouti', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., Jacksonville, Florida.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cannon', 'Affiliation': 'Johnson & Johnson Vision Care, Inc., Jacksonville, Florida.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001466'] 289,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND We evaluated the association between etiology of maternal anemia and iron status throughout infancy. METHODS Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated. RESULTS Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status. CONCLUSIONS Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5'] 290,31795820,Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial.,"Introduction. Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy. We tested the effect of presentation format on comprehension of colorectal cancer (CRC) screening probabilities to identify optimal risk communication strategies. Methods. Participants from a community foodbank and a cancer prevention center were randomized to 1 of 3 CRC screening risk presentations. The presentations used identical content but varied in format: 1) video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs. Participants completed pre- and postpresentation surveys. The primary outcome was knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores. Results. In total, 187 participants completed the study and were included in this analysis. Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46%). Approximately one-quarter had inadequate health literacy (Short Test of Functional Health Literacy in Adults marginal/inadequate: 28%; Brief Health Literacy Screener low: 18%), and about half had low numeracy (Subjective Numeracy Scale low: 54%; Graphical Literacy Measure low: 50%). We found no significant differences in total, verbatim, or gist knowledge across presentation formats (all P > 0.05). Discussion. Use of an animated pictograph to communicate risk does not appear to augment or impede knowledge of risk information. Regardless of health literacy level, difficulty understanding pictographs presenting numerical information persists. There may be a benefit to teaching or priming individuals on how to interpret numerical information presented in pictographs before communicating risk using visual methods. Trial Registry: NCT02151032.",2020,"Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy.","['187 participants completed the study and were included in this analysis', 'Patients with Low Health Literacy', 'Median age was 58 years (interquartile range [IQR]: 14 years), most participants were women (63%), and almost half had a high school education or less (46', 'Adults', 'Participants from a community foodbank and a cancer prevention center']","['video with animated pictographs, 2) video with static pictographs, and 3) audiobooklet with static pictographs']","['inadequate health literacy', 'total, verbatim, or gist knowledge across presentation formats', 'knowledge of probability/risk information regarding CRC screening, calculated as total, verbatim, and gist scores']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",187.0,0.0891652,"Enhanced visual effects, like animation, have the potential to improve comprehension of probabilistic risk information, particularly for those with lower health literacy.","[{'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Housten', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Geetanjali R', 'Initials': 'GR', 'LastName': 'Kamath', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Cantor', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nickell', 'Initials': 'N', 'LastName': 'Dixon', 'Affiliation': 'Michigan Department of Health, Southern New Hampshire University, Lansing, MI, USA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Hite', 'Affiliation': 'Department of Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kallen', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Viola B', 'Initials': 'VB', 'LastName': 'Leal', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19890296'] 291,32304829,Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial).,"PURPOSE This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations). BACKGROUND With 10 million admissions per year and short stays (often days), U.S. jails touch many individuals at risk for suicide, providing an important opportunity for suicide prevention that is currently being missed. This study (N = 800) is the first randomized evaluation of an intervention to reduce suicide risk in the vulnerable year after jail release. Given that roughly 10% of all suicides in the U.S. with known circumstances occur in the context of a criminal legal stressor, reducing suicide risk in the year after arrest and jail detention could have a noticeable impact on national suicide rates. DESIGN Pretrial jail detainees at risk for suicide were randomized to SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care. Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness. Methods accommodate short jail stays and maximize trial safety and follow-up in a large sample with severe suicide risk, access to lethal means including substances and firearms, high rates of psychiatric illness, and unstable circumstances. CONCLUSION Adequate funding was important to create the infrastructure needed to run this large trial cleanly. We encourage funders to provide adequate resources to ensure clean, well-run trials.",2020,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","['Pretrial jail detainees at risk for suicide', 'With 10 million admissions per year and short stays (often days']","[""Stanley and Brown's Safety Planning Intervention (SPI"", 'SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care']","['suicide risk', 'suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211819,"Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48503, United States of America. Electronic address: JJohns@msu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Richard_Jones@brown.edu.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, 11720 Beltsville Drive, Suite 909, Calverton, MD 20705, United States of America. Electronic address: Miller@pire.org.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': 'Brown University Warren Alpert Medical School, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Ivan_Miller_iii@brown.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Columbia University, 1051 Riverside Drive, Unit 42, New York, NY 10032, United States of America. Electronic address: Bhs2@columbia.edu.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 3535 Market Street, Room 2032, Philadelphia, PA 19104, United States of America. Electronic address: gregbrow@mail.med.upenn.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Arias', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Cerbo', 'Affiliation': 'Rhode Island Department of Corrections, 1375 Pontiac Avenue, Cranston, RI 029020, United States of America. Electronic address: Louis.Cerbo@bhddh.ri.gov.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rexroth', 'Affiliation': 'Genesee County Jail and Corizon Health, 1002 South Saginaw Street, Flint, MI 48502, United States of America. Electronic address: Julie.Rexroth@corizonhealth.com.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fitting', 'Affiliation': 'The Providence Center, 528 N. Main Street, Providence, RI, 02904, United States of America. Electronic address: hfitting@provctr.org.'}, {'ForeName': 'Danis', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Genesee Health System, 420 West 5(th) Avenue, Flint, MI 48503, United States of America. Electronic address: drussell@ghs.org.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Kubiak', 'Affiliation': 'Wayne State University School of Social Work, 5447 Woodward Avenue, Detroit, MI 48202, United States of America. Electronic address: spk@wayne.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Boston University, 715 Albany Street, Talbot Building T2W, Boston, MA 02118, United States of America. Electronic address: mdstein@bu.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Matkovic', 'Affiliation': 'Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, United States of America. Electronic address: Christopher_Matkovic@brown.edu.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Shirley_Yen_PhD@brown.edu.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Gaudiano', 'Affiliation': 'Brown University Warren Alpert Medical School and Butler Hospital, 345 Blackstone Blvd, Providence, RI 02906, United States of America. Electronic address: Brandon_Gaudiano@brown.edu.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Weinstock', 'Affiliation': 'Brown University Warren Alpert Medical School, 700 Butler Drive, Providence, RI 02906, United States of America. Electronic address: Lauren_Weinstock@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106003'] 292,31115739,The effects of threshold inspiratory muscle training in patients with obstructive sleep apnea: a randomized experimental study.,"OBJECTIVES Patients with obstructive sleep apnea (OSA) (an obstructed airway and intermittent hypoxia) negatively affect their respiratory muscles. We evaluated the effects of a 12-week threshold inspiratory muscle training (TIMT) program on OSA severity, daytime sleepiness, and pulmonary function in newly diagnosed OSA. METHODS Sixteen patients with moderate-to-severe OSA were randomly assigned to a TIMT group and 6 to a control group. The home-based TIMT program was 30-45 min/day, 5 days/week, for 12 weeks using a TIMT training device. Their apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), and forced vital capacity (FVC) scores were evaluated pre- and post-treatment. Polysomnographic (PSG) analysis showed that 9 TIMT-group patients had positively responded (TIMT-responder group: post-treatment AHI < pre-treatment) and that 7 had not (TIMT non-responder group: post-treatment AHI > pre-treatment). RESULTS Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively. A baseline AHI ≤ 29.0/h predicted TIMT-responder group patients (sensitivity 77.8%; specificity 85.7%). FVC was also significantly (P < 0.05) higher 7.2%. Baseline AHI and FEV 6.0 were significant predictors of successful TIMT-responder group intervention. OSA severity and daytime sleepiness were also significantly attenuated. CONCLUSIONS Home-based TIMT training is simple, efficacious, and cost-effective.",2020,"RESULTS Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively.","['Sixteen patients with moderate-to-severe OSA', 'patients with obstructive sleep apnea', 'Patients with obstructive sleep apnea (OSA']","['TIMT training', 'TIMT training device', 'threshold inspiratory muscle training (TIMT) program', 'TIMT', 'threshold inspiratory muscle training']","['apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), and forced vital capacity (FVC) scores', 'OSA severity and daytime sleepiness', 'FVC', 'Polysomnographic (PSG) analysis', 'ESS scores', 'OSA severity, daytime sleepiness, and pulmonary function']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",16.0,0.0105972,"RESULTS Post-treatment AHI and ESS scores were significantly (both P < 0.05) lower 6% and 20.2%, respectively.","[{'ForeName': 'Huei-Chen', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Chiang', 'Affiliation': 'School of Respiratory Therapy, Taipei Medical University, No. 250 Wuxing St., Taipei, 11031, Taiwan.'}, {'ForeName': 'Jun-Hui', 'Initials': 'JH', 'LastName': 'Ong', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Kun-Ling', 'Initials': 'KL', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Ching-Hsia', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, No.1, Daxue Rd., East Dist., Tainan City, 70101, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No.138, Shengli Rd., North Dist., Tainan City, 70403, Taiwan. yu621109@ms48.hinet.net.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01862-y'] 293,31568683,Episodic memory improvements due to noninvasive stimulation targeting the cortical-hippocampal network: A replication and extension experiment.,"INTRODUCTION The distributed cortical network of the human hippocampus is important for episodic memory. In a previous experiment, noninvasive stimulation of the hippocampal-cortical network applied for five consecutive days improved paired-associate learning measured after the stimulation regimen via cued recall (Wang et al., Science, 2014, 345, 1054). This finding has not yet been directly replicated. Furthermore, evidence for long-lasting effects of stimulation on paired-associate learning was obtained by analyzing relatively small subsamples (Wang & Voss, Hippocampus, 2015, 25, 877) and requires further evaluation. METHODS Sixteen healthy young adults participated in this replication study using the same experimental design as the original study. Participants received 1 week of active stimulation and 1 week of sham stimulation, with memory assessments occurring at the beginning (pre) and end (post) of each week. Assessments included the paired-associate task used in the original study, as well as a long-term episodic memory retention task in order to test the hypothesis that increased paired-associate learning could come at the cost of accelerated long-term forgetting. Change in memory scores was evaluated within (pre vs. post) and across (active vs. sham) weeks. RESULTS Similar to Wang et al., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation. We found no evidence that stimulation increased long-term forgetting for either week. CONCLUSION These findings confirm the beneficial effects of stimulation on episodic memory that were reported previously and indicate that stimulation-related gains in new learning ability do not come at the price of accelerated long-term forgetting.",2019,"., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation.",['Sixteen healthy young adults participated in this replication study using the same experimental design as the original study'],[],"['paired-associate learning', 'Change in memory scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]",[],"[{'cui': 'C0030210', 'cui_str': 'Paired-Associate Learning'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.0827917,"., paired-associate learning was significantly improved after 1 week of active stimulation but not after 1 week of sham stimulation.","[{'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Hermiller', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Karp', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aneesha S', 'Initials': 'AS', 'LastName': 'Nilakantan', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Voss', 'Affiliation': 'Interdepartmental Neuroscience Program, Department of Medical Social Sciences, Ken and Ruth Davee Department of Neurology, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Brain and behavior,['10.1002/brb3.1393'] 294,32301113,Randomized controlled trial of labor outcomes with action line placement at 2 hours versus 4 hours on the partograph.,"OBJECTIVE To evaluate whether treatment of slow labor progress among term nulliparous women using a 2-hour partograph action line reduces the incidence of prolonged labor versus a 4-hour action line. METHODS Randomized controlled trial of nulliparous women with a term singleton, non-macrosomic, cephalic fetus in labor attending a university hospital in Nigeria (2008-2015). For labor supervision, women were randomly assigned to the 2-hour (n=320) or 4-hour (n=320) partograph action line group. slow labor progress was treated with oxytocin augmentation The primary outcome was incidence of prolonged labor (>12 hours). Delivery mode, neonatal outcomes, and maternal satisfaction with treatment were secondary outcomes. RESULTS Prolonged labor rate did not significantly differ between the 2-hour (7/320, 2.2%) and 4-hour (8/320, 2.5%) action line groups. Secondary outcomes did not differ significantly. Oxytocin augmentation to treat slow labor progress was needed for 87 (27.2%) and 61 (19.1%) women in the respective 2- and 4-hour groups (P=0.025). Mean duration of first and second labor stages differed significantly between the groups (P<0.05). CONCLUSION The 2-hour partograph action line did not reduce incidence of prolonged labor relative to the 4-hour action line. Partograph with a 4-hour action line is recommended for labor supervision in all facilities. CLINICAL TRIAL REGISTRATION Registered at ClinicalTrials.gov as (https://clinicaltrialsgov/show/NCT02911272).",2020,The 2-hour partograph action line did not reduce incidence of prolonged labor relative to the 4-hour action line.,"['nulliparous women with a term singleton, non-macrosomic, cephalic fetus in labor attending a university hospital in Nigeria (2008-2015', 'term nulliparous women']","['partograph action line group', 'oxytocin augmentation', 'Oxytocin', 'action line placement', '2-hour partograph action line']","['Mean duration of first and second labor stages', 'slow labor progress', 'incidence of prolonged labor', 'Prolonged labor rate', 'Delivery mode, neonatal outcomes, and maternal satisfaction']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.132131,The 2-hour partograph action line did not reduce incidence of prolonged labor relative to the 4-hour action line.,"[{'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Orhue', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Benin Teaching Hospital, Benin City, Nigeria.'}, {'ForeName': 'Ignis Iribhogbe', 'Initials': 'II', 'LastName': 'Oseihie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Benin Teaching Hospital, Benin City, Nigeria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aziken', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Benin Teaching Hospital, Benin City, Nigeria.'}, {'ForeName': 'Babatunde', 'Initials': 'B', 'LastName': 'Ande', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Benin Teaching Hospital, Benin City, Nigeria.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13144'] 295,32298717,Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype.,"OBJECTIVE To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days. STUDY DESIGN After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception. RESULTS Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal. CONCLUSION Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability. IMPLICATIONS Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.",2020,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"['hormonal male contraceptive prototype', '57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen', 'Participants were counseled that they could not rely on the drug for contraception', 'Fifty-seven participants']","['oral dimethandrolone undecanoate', 'DMAU capsules daily versus placebo', 'placebo', 'oral DMAU', 'dimethandrolone undecanoate (DMAU) versus placebo', 'DMAU and placebo']",['satisfaction with active DMAU'],"[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009881', 'cui_str': 'Contraceptives, Male'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2974168', 'cui_str': 'dimethandrolone-undecanoate'}]",57.0,0.422798,More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p=0.05).,"[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. Electronic address: nguyenbt@usc.edu.'}, {'ForeName': 'Maritza T', 'Initials': 'MT', 'LastName': 'Farrant', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Yuen', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Arthi', 'Initials': 'A', 'LastName': 'Thirumalai', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.'}]",Contraception,['10.1016/j.contraception.2020.04.006'] 296,32298853,Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity.,"BACKGROUND Greater severity in childhood asthma negatively impacts functioning and quality of life. Omalizumab is effective in children aged 6 years or older with moderate to severe persistent asthma, but predicting responsiveness in severe disease requires further study. OBJECTIVE To assess response to omalizumab treatment among children using indicators of asthma severity. METHODS Post hoc analyses of randomized placebo-controlled studies of omalizumab (Inner-City Anti-IgE Therapy for Asthma [ICATA], IA05, and Preventative Omalizumab or Step-up Therapy for Fall Exacerbations [PROSE]) stratified by body mass index, eosinophil count, fractional exhaled nitric oxide levels, and baseline severity indicators (baseline percent predicted FEV 1 , previous hospitalizations, asthma exacerbations). Poisson regression analysis examined exacerbation rate reductions for body mass index, biomarkers, and severity indicators. RESULTS Children aged 6 to 11 years in IA05 (N = 576; 56% white, 17% black, 26% other/missing), ICATA (N = 237; 55% black, 43% Hispanic), and PROSE (N = 342; 59% black, 35% Hispanic) were included. Trends indicative of greater exacerbation rate change ([omalizumab - placebo]/placebo) were observed for low baseline lung function (IA05 percent predicted FEV 1 : <90%, 36% reduction, 95% CI, -53.3 to -13.5; ≥90%, 22% reduction, 95% CI, -52.1 to 27.5), previous hospitalizations (ICATA: 46% reduction with, 95% CI, -69.7 to -3.9; 24% reduction without, 95% CI, -48.1 to 10.3), frequent baseline exacerbations (IA05: ≥3, 42% reduction, 95% CI, -60.4 to -14.1; <3, 20% reduction, 95% CI, -45.2 to -15.9), and high baseline eosinophil count (IA05: ≥300 cells/μL, 39% reduction, 95% CI, -56.4 to -14.7; <300 cells/μL, 5% reduction, 95% CI, -40.6 to 52.1). CONCLUSIONS Omalizumab reduces exacerbations in children with moderate to severe persistent allergic asthma, and may provide greater benefit in children with more severe asthma subtypes.",2020,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","['Children aged 6-11 years in IA05 (N=576', 'IA05: ≥300 cells/μL, 39% reduction, 95%CI: -56.4, -14.7; <300 cells/μL, 5% reduction, 95%CI: -40.6, 52.1', 'children using indicators of asthma severity', 'children with moderate-to-severe persistent allergic asthma', ' 56% White, 17% Black, 26% Other/Missing), ICATA (N=237; 55% Black, 43% Hispanic), and PROSE (N=342; 59% Black, 35% Hispanic', 'children aged ≥6 years with moderate-to-severe persistent asthma']","['Omalizumab', 'placebo', 'omalizumab']","['forced expiratory volume in 1 second [ppFEV 1 ], prior hospitalizations, asthma exacerbations', 'high baseline eosinophil count', 'body mass index (BMI), eosinophil count, fractional exhaled nitric oxide (FeNO) levels, and baseline severity indicators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.524462,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc, Los Altos, Calif.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.033'] 297,32302791,"A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.","This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.",2020,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","['chronic pain', '300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study']","['Structural equation modeling (SEM', 'telehealth group sessions of CT, MM, or AS', 'chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS', 'cognitive, behavioral and mindfulness-based psychosocial treatments']","['Pain Interference scale', 'cognitive content, cognitive process, and/or activity level', 'PROMIS 5-item']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",300.0,0.103487,"We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mendoza', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Battalio', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Borckardt', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'The University of Queensland, 330 McElwain Building, Brisbane 4072, Queensland, Australia.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106000'] 298,32303377,"Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial.","BACKGROUND Current treatment of postdural puncture headache includes epidural blood patch (EBP), which is invasive and may result in rare but severe complications. Sphenopalatine ganglion block is suggested as a simple, minimally invasive treatment for postdural puncture headache. We aimed to investigate the analgesic effect of a transnasal sphenopalatine ganglion block with local anaesthetic vs saline. METHODS We conducted a blinded, randomised clinical trial including adults fulfilling the criteria for EBP. Participants received a sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline). Primary outcome was pain in upright position 30 min post-block, measured on a 0-100 mm VAS. RESULTS We randomised 40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively. At 30 min after sphenopalatine ganglion block, the median pain intensity in upright position was 26 mm in the local anaesthetic group vs 37 mm in the placebo group (estimated median difference: 5 mm; 95% confidence interval: -14 to 21; P=0.53). In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). CONCLUSIONS Administration of a sphenopalatine ganglion block with local anaesthetic had no statistically significant effect on pain intensity after 30 min compared with placebo. However, pain was reduced and EBP was avoided in half the patients of both groups, which suggests a major effect not necessarily attributable to local anaesthetics. CLINICAL TRIAL REGISTRATION NCT03652714.",2020,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). ","['adults fulfilling the criteria for EBP', '40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively', 'postdural puncture headache']","['Sphenopalatine ganglion block', 'placebo', 'transnasal sphenopalatine ganglion block with local anaesthetic vs saline', 'epidural blood patch (EBP', 'sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline']","['pain in upright position 30 min post-block, measured on a 0-100 mm VAS', 'median pain intensity in upright position', 'pain', 'EBP', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}]","[{'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}]",40.0,0.790752,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76). ","[{'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Jespersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark. Electronic address: mads.seit.jespersen@regionh.dk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Ægidius', 'Affiliation': 'Department of Neurology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Fabritius', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duch', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rye', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.025'] 299,31240541,APAP therapy does not improve impaired sleep quality and sympatho-vagal balance: a randomized trial in patients with obstructive sleep apnea and systolic heart failure.,"PURPOSE In heart failure with reduced ejection fraction (HFrEF), the effects of automatic positive airway pressure therapy (APAP) for obstructive sleep apnea (OSA) on sleep quality and sympatho-vagal balance (SVB) are unknown. METHODS In this randomized controlled trial (6 months of APAP vs. nasal strips as control), sleep quality and SVB in patients with HFrEF and OSA were monitored. The distinction was made between different breathing conditions (5-min segments of OSA or normal breathing [NB] during stable N2 sleep) at baseline (T0), APAP initiation (T1), and 6 months of successful APAP treatment (T2). RESULTS Of 75 patients enrolled, 61 were men with average age of 65 ± 12 years and LVEF of 31 ± 9%; 37 patients were randomized into the APAP and 38 into the control (nasal strips only) group. At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing. Respiratory indices and oxygen saturation all significantly improved at both T1 and T2, but at 6 months, APAP had no clinically relevant effect on objective sleep quality versus control. In fact, in patients with HFrEF (n = 23 with data suitable for HRV analysis), there was even a trend (p = 0.097) towards an additional 17% increase in LF/HF at T2 in the therapy group, suggesting (undesired) increased SVB in the APAP group. CONCLUSION Treatment of OSA in patients with systolic HF improves respiratory indices but does not have a favorable effect on sleep quality. While OSA per se was associated with an increase in sympathetic drive, APAP treatment was not associated with a reduction in sympathetic drive. After 6 months of treatment, there was even a trend towards additional increases in sympathetic drive in the APAP group.",2020,"At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing.","['patients with obstructive sleep apnea and systolic heart failure', 'obstructive sleep apnea (OSA', 'patients with HFrEF and OSA', '75 patients enrolled, 61 were men with average age of 65\u2009±\u200912\xa0years and LVEF of 31\u2009±\u20099%; 37 patients']","['APAP', 'APAP therapy', 'APAP vs. nasal strips', 'OSA', 'automatic positive airway pressure therapy (APAP']","['sleep quality and SVB', 'sleep quality and sympatho-vagal balance', 'sympathetic drive', 'SVB', 'objective sleep quality', 'sleep quality', 'sleep quality and sympatho-vagal balance (SVB', 'LF/HF', 'Respiratory indices and oxygen saturation', 'sympathetic drive (SVB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index (assessment scale)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",75.0,0.0360663,"At T0, OSA was associated with a 17% increase in the low-frequency/high-frequency component ratio of heart rate variability (LF/HF) versus baseline, suggesting an increase in sympathetic drive (SVB) with OSA compared with normal breathing.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Spiesshoefer', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aries', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giannoni', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Respiratory Physiology Laboratory, Department of Neurology with Institute for Translational Neurology, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bitter', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany. akleemeyer@hdz-nrw.de.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01868-6'] 300,32301388,Comparison of the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm among patients awakening from general anaesthesia: A prospective randomised clinical trial.,"BACKGROUND Coughing and laryngospasm are undesirable consequences occurring when patients awaken from general anaesthesia. The objective of the study aimed to compare the effects of intravenous propofol and propofol with low-dose ketamine on preventing postextubation cough and laryngospasm. METHODS In all, 120 patients scheduled surgery under general anaesthesia were randomly assigned into three groups. Patients in the control group (C-group) obtained intravenous 0.9% NaCl, while patients in the propofol group (P-group) obtained intravenous 0.25mg/kg propofol and patients in the propofol combined with ketamine group (PK-group) obtained intravenous 0.25mg/kg of propofol plus 0.15mg/kg of ketamine. Drugs were administered before extubation. Incidence and severity of coughing and laryngospasm were recorded by a blinded anaesthesiologist. RESULTS Subjects of the PK-group (25%) experienced significantly reduced incidence of postoperative cough than that in the P-group (55%) and C-group (72.5%) (all P < 0.05). The severity of cough in the PK-group was significantly less than that in the P-group and C-group (P = 0.039 and P < 0.001, respectively). No significant difference was found in the incidence and severity of laryngospasm between comparison groups. CONCLUSION Intravenous combination of propofol and low-dose ketamine significantly reduced the incidence and severity among patients awakening from general anaesthesia.",2020,,['patients awakening from general anaesthesia'],['propofol and propofol with low-dose ketamine'],['postextubation cough and laryngospasm'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0023066', 'cui_str': 'Laryngeal spasm'}]",,0.0201312,,"[{'ForeName': 'Yanipan', 'Initials': 'Y', 'LastName': 'Chungsamarnyart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Jiranun', 'Initials': 'J', 'LastName': 'Pairart', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Sithapan', 'Initials': 'S', 'LastName': 'Munjupong', 'Affiliation': 'Department of Anesthesiology, Phramongkutklao Hospital and Phramongkutklao Collage of Medicine, Bangkok, Thailand.'}]",Journal of perioperative practice,['10.1177/1750458920912636'] 301,32301407,"Effect of daily consumption of cranberry beverage on insulin sensitivity and modification of cardiovascular risk factors in adults with obesity: a pilot, randomised, placebo-controlled study.","Cranberries are high in polyphenols, and epidemiological studies have shown that a high-polyphenol diet may reduce risk factors for diabetes and CVD. The present study aimed to determine if short-term cranberry beverage consumption would improve insulin sensitivity and other cardiovascular risk factors. Thirty-five individuals with obesity and with elevated fasting glucose or impaired glucose tolerance participated in a randomised, double-blind, placebo-controlled, parallel-designed pilot trial. Participants consumed 450 ml of low-energy cranberry beverage or placebo daily for 8 weeks. Changes in insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, RMR, glucose tolerance, lipid profiles and oxidative stress biomarkers were evaluated. Change in insulin sensitivity via hyperinsulinaemic-euglycaemic clamp was not different between the two groups. Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2·18 v. +20·81 pg/ml; P = 0·02). When stratified by baseline C-reactive protein (CRP) levels, participants with high CRP levels (>4 mg/l) benefited more from cranberry consumption. In this group, significant differences in the mean change from baseline between the cranberry (n 10) and the placebo groups (n 7) in levels of TAG (-13·75 v. +10·32 %; P = 0·04), nitrate (+3·26 v. -6·28 µmol/l; P = 0·02) and 8-isoprostane (+0·32 v. +30·8 pg/ml; P = 0·05) were observed. These findings indicate that 8 weeks of daily cranberry beverage consumption may not impact insulin sensitivity but may be helpful in lowering TAG and changing certain oxidative stress biomarkers in individuals with obesity and a proinflammatory state.",2020,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","['Thirty-five obese individuals with elevated fasting glucose or impaired glucose tolerance participated', 'Obese Adults', 'obese individuals with a proinflammatory state']","['low-calorie cranberry beverage or placebo', 'polyphenol diet', 'placebo', 'Daily Consumption of Cranberry Beverage', 'Placebo']","['Insulin Sensitivity and Modification of Cardiovascular Risk Factors', 'Levels of 8-isoprostane (biomarker of lipid peroxidation', 'insulin sensitivity via hyperinsulinemic euglycemic clamp', 'insulin sensitivity and cardiovascular risk factors including vascular reactivity, blood pressure, resting metabolic rate, glucose tolerance, lipid profiles, and oxidative stress biomarkers', 'insulin sensitivity and other cardiovascular risk factors', 'levels of triglyceride']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.644559,"Levels of 8-isoprostane (biomarker of lipid peroxidation) decreased in the cranberry group but increased in the placebo group (-2.18 pg/mL vs +20.81 pg/mL, p=0.02).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Zhang', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}, {'ForeName': 'Robbie S', 'Initials': 'RS', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA70808, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA02349, USA.'}]",The British journal of nutrition,['10.1017/S0007114520001336'] 302,32299792,Teaching the National Institutes of Health Stroke Scale to Paramedics (E-Learning vs Video): Randomized Controlled Trial.,"BACKGROUND Prompt and accurate identification of stroke victims is essential to reduce time from symptom onset to adequate treatment and to improve neurological outcomes. Most neurologists evaluate the extent of neurological deficit according to the National Institutes of Health Stroke Scale (NIHSS), but the use of this scale by paramedics, the first healthcare providers to usually take care of stroke victims, has proven unreliable. This might be, at least in part, due to the teaching method. The video used to teach NIHSS lacks interactivity, while more engaging electronic learning (e-learning) methods might improve knowledge acquisition. OBJECTIVE This study was designed to evaluate whether a highly interactive e-learning module could enhance NIHSS knowledge acquisition in paramedics. METHODS A randomized controlled trial comparing a specially designed e-learning module with the original NIHSS video was performed with paramedics working in Geneva, Switzerland. A registration number was not required as our study does not come into the scope of the Swiss federal law on human research. The protocol was nevertheless submitted to the local ethics committee (Project ID 2017-00847), which issued a ""Declaration of no objection."" Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward. The primary outcome was overall performance in the study quiz, which contained 50 questions. Secondary outcomes were performance by NIHSS item, time to course and quiz completion, user satisfaction regarding the learning method, user perception of the course duration, and probability the user would recommend the course to a colleague. RESULTS The study was completed by 39 paramedics. There was a better overall median score (36/50 vs 33/50, P=.04) and a higher degree of satisfaction regarding the learning method in the e-learning group (90% vs 37%, P=.002). Users who had followed the e-learning module were more likely to recommend the course to a colleague (95% vs 63%, P=.02). Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01). Time to quiz completion was similar between groups (25 vs 38 minutes, P=.12). CONCLUSIONS Use of an e-learning module shows promising results in teaching the NIHSS to paramedics.",2020,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","['paramedics', 'Paramedics were excluded if they had prior knowledge of or previous training in the NIHSS, or if they had worked in a neurology or neurosurgery ward', 'paramedics working in Geneva, Switzerland']",['highly interactive e-learning module'],"['overall median score', 'overall performance', 'Time to quiz completion', ""performance by NIHSS item, time to course and to quiz completion, user satisfaction regarding the learning method, user's perception of the course duration, and probability the user would recommend the course to a colleague""]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0832196,"Paramedics in the e-learning group took more time to complete the course (93 vs 59 minutes, P<.001), but considered the duration to be more adequate (75% vs 32%, P=.01).","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Koka', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottet', 'Affiliation': 'Division of Emergency Medicine, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Carrera', 'Affiliation': 'Stroke Center, Department of Neurology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anaesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/18358'] 303,31197639,Effect of mean apnea-hypopnea duration in patients with obstructive sleep apnea on clinical and polysomnography parameter.,"OBJECTIVE Apnea-hypopnea index is the number of apnea-hypopnea events observed during polysomnography within an hour. Mean apnea-hypopnea duration is the mean duration of all apneas and hypopneas. In this study, we aimed to investigate the association of mean apnea-hypopnea duration in patients with obstructive sleep apnea with clinical and polysomnographic parameters. METHODS In our hospital, a total of 764 patients were diagnosed with OSA by polysomnography in 2017. Age, body mass index, and the current diseases were recorded. Sleep structures obtained from polysomnography readings, blood oxygen levels, apnea-hypopnea index, and mean average duration were recorded. Patients with mean average duration of 20 s or more were assigned to the long average duration group and those with less than 20 s were assigned to the short average duration group. Groups were compared in terms of clinical and polysomnographic parameters. RESULTS Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group. There was statistically significantly more male patients and higher neck circumference in the MAD group. Total wake duration, percentage of sleep, stage 3, stage 1, and mean oxygen saturation percentage of the long average duration group were significantly reduced. CONCLUSION In present study, the patients with obstructive sleep apnea with long average duration were found to have more negative effects of sleep apnea than the patients with short average duration. We think that the use of mean apnea-hypopnea duration as an indicator with apnea-hypopnea index will be beneficial for the follow-up and treatment of the disease.",2020,"RESULTS Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group.","['764 patients were diagnosed with OSA by polysomnography in 2017', 'patients with obstructive sleep apnea with clinical and polysomnographic parameters', 'patients with obstructive sleep apnea on clinical and polysomnography parameter', 'Patients with mean average duration of 20\xa0s or more were assigned to the long average duration group and those with less than 20\xa0s were assigned to the short average duration group', 'patients with obstructive sleep apnea with long average duration']",[],"['Snoring, witnessed apnea, morning tiredness, and hypertension', 'Total wake duration, percentage of sleep, stage 3, stage 1, and mean oxygen saturation percentage', 'Mean apnea-hypopnea duration', 'neck circumference', 'Sleep structures obtained from polysomnography readings, blood oxygen levels, apnea-hypopnea index, and mean average duration', 'sleep apnea', 'mean apnea-hypopnea duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",[],"[{'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}]",764.0,0.0140234,"RESULTS Snoring, witnessed apnea, morning tiredness, and hypertension were significantly higher in the long average duration group.","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Saraç', 'Affiliation': 'Department of Pulmonary Medicine, Sureyyapasa Teaching and Research Hospital, University of Medical Sciences Istanbul, Istanbul, Turkey. semasarac16@hotmail.com.'}, {'ForeName': 'Gulgun Cetintaş', 'Initials': 'GC', 'LastName': 'Afsar', 'Affiliation': 'Department of Pulmonary Medicine, Sureyyapasa Teaching and Research Hospital, University of Medical Sciences Istanbul, Istanbul, Turkey.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01870-y'] 304,32299733,Prospective randomized multicentre comparison on sibling oocytes comparing G-Series media system with antioxidants versus standard G-Series media system.,"RESEARCH QUESTION Does the inclusion of three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA) improve human embryo development and pregnancy potential? DESIGN Prospective randomized multicentre comparison of sibling oocytes. A total of 1563 metaphase II oocytes from 133 patients in two IVF centres. Day 3 embryo and day 5/6 blastocyst quality were assessed. Good embryo quality on day 3 was defined as 8 to 10 cells with even cells and low fragmentation; good quality blastocysts as 3BB or greater. Clinical outcome was assessed on transfers of fresh or vitrified-warmed blastocyst on day 5. RESULTS Of the two-pronuclei, 40.7% (G-Series) and 50.2% (G-Series with A3 group) resulted in good quality embryos on day 3 (P < 0.05). The implantation rate by fetal sac was 39.2% and 50.6%, and by fetal heartbeat was 37.8% and 47.1% for the G-Series and G-Series with A3 group, respectively. When stratified by female patient age, patients 35-40 years had an implantation rate by fetal sac and heart of 23.5% in the G-Series compared with 57.5% (P < 0.05) and 50.0% (P < 0.05) in the A3 group. The ongoing pregnancies in patients 35-40 years were significantly higher in the A3 group (50%) compared with the control (25.8%) (P < 0.05). CONCLUSIONS The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate. Supplementation of antioxidants to IVF and culture media may therefore improve the viability of human embryos in assisted reproductive technologies, plausibly through the reduction of oxidative stress.",2020,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,['A total of 1563 metaphase II oocytes from 133 patients in two IVF centres'],"['three antioxidants (A3), acetyl-l-carnitine (ALC), N-acetyl-l-cysteine (NAC) and alpha-lipoic acid (ALA', 'G-Series media system with antioxidants versus standard G-Series media system']","['Good embryo quality', 'implantation rate by fetal sac and heart', 'transfers of fresh or vitrified-warmed blastocyst on day 5', 'implantation and pregnancy rate', 'fetal heartbeat', 'implantation rate by fetal sac', 'good quality embryos']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}]",,0.091776,The presence of antioxidants during IVF and embryo culture for patients 35-40 years resulted in a significant increase in implantation and pregnancy rate.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gardner', 'Affiliation': 'School of BioSciences, University of Melbourne, Parkville, Australia; Melbourne IVF, East Melbourne, Australia. Electronic address: david.gardner@unimelb.edu.au.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kuramoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigetoshi', 'Initials': 'S', 'LastName': 'Mitzumoto', 'Affiliation': ""Kuramoto Women's Clinic, Reproductive Medicine, Fukuoka, Japan.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Montag', 'Affiliation': 'ilabcomm GmbH, Eisenachstrasse 34, Sankt Augustin, Germany.'}, {'ForeName': 'Atsumi', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Kiba Park Clinic, Reproductive Medicine, Tokyo, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.026'] 305,32299734,A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval.,"RESEARCH QUESTION Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation? DESIGN A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set. RESULTS Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups. CONCLUSION The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.",2020,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"['pain relief during oocyte retrieval', '170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre']","['pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine', 'fentanyl and 5 mg midazolam', 'pethidine', 'pethidine and diazepam', 'midazolam', 'diazepam', 'fentanyl and midazolam']","['postoperative side-effects', 'clinical pregnancy and ongoing pregnancy rates', 'pain levels', 'Vaginal and abdominal pain levels', 'vaginal and abdominal pain levels', 'vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates', 'abdominal pain', 'abdominal pain level during retrieval assessed by linear visual analogue scale', 'sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",170.0,0.597173,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"[{'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong. Electronic address: lsf087@ha.org.hk.'}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Nga', 'Affiliation': 'Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.021'] 306,31461577,Neuromuscular electrical stimulation is feasible in patients with acute heart failure.,"AIMS In acute heart failure (AHF), immobilization is caused because of unstable haemodynamics and dyspnoea, leading to protein wasting. Neuromuscular electrical stimulation (NMES) has been reported to preserve muscle mass and improve functional outcomes in chronic disease. NMES may be effective against protein wasting frequently manifested in patients with AHF; however, whether NMES can be implemented safely without any adverse effect on haemodynamics has remained unknown. This study aimed to examine the feasibility of NMES in patients with AHF. METHODS AND RESULTS Patients with AHF were randomly assigned to the NMES or control group. The intensity of the NMES group was set at 10-20% maximal voluntary contraction level, whereas the control group was limited at a visible or palpable level of muscle contraction. The sessions were performed 5 days per week since the day after admission. Before the study implementation, we set the feasibility criteria with following items: (i) change in systolic blood pressure (BP) > ±20 mmHg during the first session; (ii) increase in heart rate (HR) > +20 b.p.m. during the first session; (iii) development of sustained ventricular arrhythmia, atrial fibrillation (AF), and paroxysmal supraventricular tachycardia during all sessions; (iv) incidence of new-onset AF during the hospitalization period < 40%; and (v) completion of the planned sessions by >70% of patients. The criteria of feasibility were set as follows; the percentage to fill one of (i)-(iii) was <20% of the total subjects, and both (iv) and (v) were satisfied. A total of 73 patients (median age 72 years, 51 men) who completed the first session were analysed (NMES group, n = 34; control group, n = 39). Systolic BP and HR variations were not significantly different between two groups (systolic BP, P = 0.958; HR, P = 0.665). Changes in BP > ±20 mmHg or HR > +20 b.p.m. were observed in three cases in the NMES group (8.8%) and five in the control group (12.8%). New-onset arrhythmia was not observed during all sessions in both groups. During hospitalization, one patient newly developed AF in the NMES group (2.9%), and one developed AF (2.6%) and two lethal ventricular arrhythmia in the control group. Thirty-one patients in the NMES group (91%) and 33 patients in the control group (84%) completed the planned sessions during hospitalization. This study fulfilled the preset feasibility criteria. CONCLUSIONS NMES is feasible in patients with AHF from immediately after admission.",2019,"Systolic BP and HR variations were not significantly different between two groups (systolic BP, P = 0.958; HR, P = 0.665).","['patients with AHF', 'patients with acute heart failure', 'Patients with AHF', 'patients with AHF from immediately after admission', '73 patients (median age 72 years, 51 men) who completed the first session were analysed (NMES group, n = 34; control group, n = 39']","['Neuromuscular electrical stimulation (NMES', 'Neuromuscular electrical stimulation', 'NMES']","['systolic blood pressure (BP) > ±20 mmHg during the first session; (ii) increase in heart rate (HR', 'Systolic BP and HR variations', 'New-onset arrhythmia', 'lethal ventricular arrhythmia', 'sustained ventricular arrhythmia, atrial fibrillation (AF), and paroxysmal supraventricular tachycardia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030590', 'cui_str': 'Paroxysmal supraventricular tachycardia (disorder)'}]",51.0,0.0241022,"Systolic BP and HR variations were not significantly different between two groups (systolic BP, P = 0.958; HR, P = 0.665).","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Health Sciences, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Tanimura', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kazama', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Shimojo', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Etsuo', 'Initials': 'E', 'LastName': 'Iwata', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Sayano', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hiraiwa', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sano', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Awaji', 'Affiliation': 'Department of Cardiology, Nagoya Ekisaikai Hospital, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Okumura', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",ESC heart failure,['10.1002/ehf2.12504'] 307,31981567,Effect of Olfactory Stimulation by L-Menthol on Laboratory-Induced Dyspnea in COPD.,"BACKGROUND Inhalation of L-menthol as a transient receptor potential melastatin 8 agonist induces a cooling sensation in the airway. This cooling sensation induced through olfactory stimulation by L-menthol (OSM) alleviates dyspnea in healthy humans. Therefore, we investigated effects of OSM on the neural respiratory drive (NRD) and multidimensional aspects of dyspnea induced by inspiratory resistive loaded breathing in COPD. METHODS In total, 28 patients with COPD and 14 control participants were included in this randomized, single-blinded, placebo-controlled, crossover study. OSM was administered using an L-menthol-scented patch, whereas placebo was administered using olfactory stimulation by strawberry-scented patch: placebo (OSP). Sham condition was measured by breathing through a face mask without a OSP. Dyspnea was evoked by breathing through the inspiratory resistance of 20 or 30 cm H 2 O/L/s and measured using the Multidimensional Dyspnea Profile. NRD was estimated using the electromyogram activities of the parasternal intercostal muscles. RESULTS Compared with sham and OSP, OSM did not alter the breathing pattern/timing and NRD during inspiratory resistive loading; however, it significantly alleviated the physical and mental breathing effort, air hunger, breathing discomfort, anxiety, and fear during inspiratory resistive loaded breathing in patients with COPD. However, although OSM reduced the air hunger, mental breathing effort, and unpleasantness, no significant improvement on affective dimension of dyspnea by OSM was observed in control participants. CONCLUSIONS Our findings suggest that OSM activated the sense of inspiratory flow that achieved dyspnea relief in patients with COPD. TRIAL REGISTRY UMIN Clinical Trials Registry (UMIN-CTR); No.: UMIN000033822; URL: https://www.umin.ac.jp/ctr/index.htm.",2020,"Compared with sham and OSP, OSM did not alter the breathing pattern/timing and NRD during inspiratory resistive loading; however, it significantly alleviated the physical and mental breathing effort, air hunger, breathing discomfort, anxiety, and fear during inspiratory resistive loaded breathing in patients with COPD.","['chronic obstructive pulmonary disease (COPD', 'patients with COPD', '28 patients with COPD and 14 participants in control', 'healthy humans', 'Chronic Obstructive Pulmonary Disease']","['L-menthol (OSM', 'placebo (OSP', 'placebo', 'Olfactory Stimulation by L-menthol', 'OSM', 'inspiratory resistive loaded breathing']","['Multidimensional Dyspnea Profile (MDP', 'affective dimension of dyspnea by OSM', 'Dyspnea', 'breathing pattern/timing and NRD', 'dyspnea relief', 'OSM reduced the air hunger, mental breathing effort, and unpleasantness', 'NRD', 'physical and mental breathing effort, air hunger, breathing discomfort, anxiety, and fear during inspiratory resistive loaded breathing']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0052834', 'cui_str': 'B30-MDP'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0231848', 'cui_str': 'Air hunger (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]",28.0,0.0925659,"Compared with sham and OSP, OSM did not alter the breathing pattern/timing and NRD during inspiratory resistive loading; however, it significantly alleviated the physical and mental breathing effort, air hunger, breathing discomfort, anxiety, and fear during inspiratory resistive loaded breathing in patients with COPD.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kanezaki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Care Sciences, Himeji Dokkyo University, Himeji, Hyogo, Japan. Electronic address: kmasashi@gm.himeji-du.ac.jp.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Terada', 'Affiliation': 'Terada Clinic, Respiratory Medicine and General Practice, Himeji, Hyogo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Ebihara', 'Affiliation': 'Department of Rehabilitation Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.'}]",Chest,['10.1016/j.chest.2019.12.028'] 308,31109915,Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial.,"BACKGROUND We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder. METHODS In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123. FINDINGS Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache). INTERPRETATION ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care. FUNDING US National Institute on Alcohol Abuse and Alcoholism.",2019,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","['patients living with HIV and alcohol use disorder', 'Between Jan 28, 2013, and July 14, 2017', 'Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study', 'Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black', '57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3', 'patients with HIV and alcohol use disorder', 'five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment', '128 of 351 patients assessed for eligibility were eligible', 'Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence']","['integrated stepped alcohol treatment (ISAT', 'ISAT', 'addiction physician management plus motivational enhancement therapy', 'Integrated stepped alcohol treatment']","['number of drinks', 'number of drinks per week over the past 30 days', 'alcohol consumption', 'Adverse events', 'alcohol use and HIV outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",128.0,0.136665,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'Washington DC Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'Veterans Affairs NY Harbor Healthcare System and New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30076-1'] 309,32298407,Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals.,"BACKGROUND Little is known about the effect of health professionals' advice on promoting healthy lifestyle behaviors (diet and exercise) among breast cancer patients. PURPOSE To identify predictors of receiving lifestyle advice from health professionals and its impact on healthy lifestyle behaviors. METHODS We used data from a randomized controlled trial of an interactive, cancer-communication video program using African American breast cancer survivor stories for newly diagnosed African American breast cancer patients (Stages 0-III). Participants completed five interviews over 2 years. This intervention did not significantly affect changes in quality-of-life outcomes. In secondary analysis, we examined differences in baseline variables between women with and without diabetes. Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. RESULTS Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes. At 2 year follow-up, a greater proportion of women with (vs. without) diabetes reported receiving advice by a doctor/health professional to improve their diet (73% vs. 57%, p = .04,). Predictors of receiving dietary advice were obesity, diabetes, and breast-conserving surgery (each p < .05). Women receiving dietary advice were 2.75 times more likely to report improving their diet (95% confidence interval: 1.17, 6.46) at follow-up, but receiving physical activity advice was not significantly associated with patients reporting an increase in exercise. CONCLUSIONS Although receiving dietary advice predicted dietary improvements, receiving exercise advice did not lead to an increase in physical activity. CLINICAL TRIAL REGISTRATION Trial Number NCT00929084.",2020,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. ","['Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes', 'newly diagnosed African American breast cancer patients (Stages 0-III', 'African American Women', 'women with and without diabetes', 'breast cancer patients']","['interactive, cancer-communication video program', 'African American breast cancer survivor stories']","['physical activity', 'quality-of-life outcomes', 'obesity, diabetes, and breast-conserving surgery', 'physical activity advice', 'Lifestyle Behaviors', 'exercise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",228.0,0.0709718,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up. ","[{'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Jarvandi', 'Affiliation': 'Department of Family and Consumer Sciences, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pérez', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Margenthaler', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa020'] 310,32304710,Presoaking of Semitendinosus Graft With Vancomycin Does Not Alter Its Biomechanical Properties: A Biomechanical In Vitro-Controlled Study Using Graft From Living Donors.,"PURPOSE To compare the biomechanical properties of human semitendinosus graft presoaked with or without vancomycin under a load to failure tensile test. METHODS Thirty semitendinosus grafts harvested during anterior cruciate ligament reconstruction were included. These were dissected equally into 2 halves and subsequently randomly allocated to a vancomycin group and to a control group. A digital caliper was used to precisely measure each samples thickness, length, and width. For the vancomycin group, samples were presoaked in a solution of 5 mg/mL vancomycin for a duration of 10 minutes and the control group samples were presoaked in a physiological serum equally for 10 minutes. Mechanical testing was performed on a universal testing machine (Instron 5566-A) after a preconditioning of 10 cycles of 1 mm extension and a progression of 10 mm/min to failure for each sample. The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the ultimate tensile stress, the ultimate tensile elongation (UTE) before failure and the elasticity limit. RESULTS For the control group, the average Young's modulus value was 4.8 ± 0.8, the average UTS was 25.2 ± 5.2 MPa, the average percentage of UTE was 78 ± 17%, and the average elasticity limit value was 17.3 ± 5.3 MPa. For the vancomycin group, the average Young's modulus value was 4.7 ± 0.9, the average ultimate tensile stress was 24.1 ± 6.1 MPa, the average percentage of UTE was 82 ± 14%, and the average elasticity limit value was 18.5 ± 5.9 MPa. No significant difference was observed between the 2 groups for all investigated parameters. CONCLUSIONS Presoaking of human semitendinosus graft with vancomycin does not alter its biomechanical properties. CLINICAL RELEVANCE This study demonstrates that vancomycin presoaking used to prevent post-anterior cruciate ligament reconstruction septic arthritis does not affect immediate biomechanical properties of semitendinosus tendons.",2020,"The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit. ","['graft from living donors', 'Thirty semitendinosus grafts harvested during ACL reconstruction were included']","['vancomycin', 'human semitendinosus graft pre-soaked with or without vancomycin']","['stress-strain curve', 'Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit']","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0204774', 'cui_str': 'Soak'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.0163028,"The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit. ","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Jacquet', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Jaubert', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pioger', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Abderahmane', 'Initials': 'A', 'LastName': 'Sbihi', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Pithioux', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Le Baron', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France; Institut de Chirurgie Orthopédique et Sportive, Marseille, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Ollivier', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France. Electronic address: matthieu.ollivier@ap-hm.fr.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.03.037'] 311,32304731,Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity.,"Food insecurity, the inability to acquire adequate food due to insufficient resources for food, is associated with an increased risk for obesity and associated health problems. This study assessed the feasibility and initial efficacy of a prefilled online grocery shopping cart (i.e., default option) in promoting healthier grocery purchases in individuals with food insecurity. Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits. Compared to nutrition education, the default shopping cart resulted in the purchase of significantly more ounces of whole grains (Mean Difference [M diff ] = -4.05; 95% Confidence Interval [CI] = -6.14, -1.96; p < .001), cups of fruits (M diff  = -1.51; 95% CI = -2.51, -0.59; p = .002) and vegetables (M diff  = -2.21; 95% CI = -4.01, -0.41; p = .02), foods higher in fiber (mg; M diff  = -15.65; 95% CI = -27.43, -3.87; p = .01), and lower in sodium (mg; M diff  = 1642.66; 95% CI = 660.85, 2624.48; p = .002), cholesterol (mg; M diff  = 463.86; 95% CI = 198.76, 728.96; p = .001), and grams of fat (M diff  = 75.42; 95% CI = 42.81, 108.03; p < .001) and saturated fat (M diff  = 26.20; 95% CI = 14.07, 38.34; p < .001). The use of a default online shopping cart appears to improve nutritional quality of food purchases in individuals facing financial constraints.",2020,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","['individuals with food insecurity', 'Fifty participants recruited from food pantries in New York in 2018 were randomized to', 'individuals facing financial constraints']","['review nutrition information before purchasing groceries online (n\u202f=\u202f23) or modify a prefilled, nutritionally balanced online shopping cart (n\u202f=\u202f27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits', 'prefilled online grocery shopping cart (i.e., default option']","['grams of fat (M diff', 'nutritional quality of food purchases', 'saturated fat', 'feasibility and initial efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441061', 'cui_str': 'Shopping cart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.161297,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","[{'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Coffino', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA. Electronic address: jcoffino@albany.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, University at Albany, State University of New York, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA.'}]",Appetite,['10.1016/j.appet.2020.104714'] 312,32303784,Comparison of types 2 and 3 quadratus lumborum muscle blocks : Open inguinal hernia surgery in patients with spinal anesthesia.,"OBJECTIVE The efficacy of quadratus lumborum muscle block (QLB) in abdominal surgery is known; however, the efficacy of different QLB types is unclear. The objective of this study was to investigate the effects of ultrasound-guided QLB type 2 and type 3 on postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery. MATERIAL AND METHODS In this study 60 patients undergoing open inguinal hernia surgery were randomly assigned to 3 groups. Group QLB2 received ultrasound-guided QLB type 2 and group QLB3 received ultrasound-guided QLB type 3 with 0.25% 20 mL bupivacaine. In the control group (group C) no intervention was performed. Postoperative analgesia was performed intravenously with 1000 mg paracetamol every 6 h and patient-controlled analgesia with fentanyl. Postoperative visual analog scale scores (VAS), opioid consumption, and first analgesic requirement time were evaluated. RESULTS Fentanyl consumption was significantly higher in group C compared to the other groups at all time intervals (p < 0.05). Fentanyl consumption was significantly higher in group QLB2 compared to QLB3 at the 4-8 h, 8-24 h, and total 24 h. Passive VAS 4h and 8 h, active VAS 4h, 8h, and 12 h were significantly lower in group QLB3 compared to QLB2 (p < 0.05). The first analgesic time was significantly later in group QLB2 compared to group C (280.52 ± 89.20 min and 183.75 ± 42.79 min, respectively) and even later in group QLB3 compared to the other two groups (463.42 ± 142.43 min, p < 0.05). CONCLUSION The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery. Furthermore, QLB3 provided more effective and longer lasting postoperative analgesia and lower opioid consumption compared to QLB2.",2020,The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery.,"['patients undergoing inguinal hernia surgery', 'patients with spinal anesthesia', '60 patients undergoing open inguinal hernia surgery']","['QLB2 and QLB3', 'types 2 and 3 quadratus lumborum muscle blocks : Open inguinal hernia surgery', 'quadratus lumborum muscle block (QLB', 'bupivacaine', 'ultrasound-guided QLB type 2 and type 3', 'paracetamol every 6\u202fh and patient-controlled analgesia with fentanyl', 'QLB3', 'ultrasound-guided QLB type 2 and group']","['analgesic time', 'effective and longer lasting postoperative analgesia and lower opioid consumption', 'Postoperative visual analog scale scores (VAS), opioid consumption, and first analgesic requirement time', 'postoperative opioid consumption and pain scores', 'Fentanyl consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",60.0,0.0368686,The use of QLB2 and QLB3 decreased postoperative opioid consumption and pain scores in patients undergoing inguinal hernia surgery.,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bagbanci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kursad', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey. m_yayik@hotmail.com.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karadeniz', 'Affiliation': 'Department of General Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00766-x'] 313,31641325,Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans.,"Background African Americans have disproportionately high rates of cardiovascular disease (CVD). Left ventricular hypertrophy (LVH) is an independent risk factor for CVD and may contribute to this disparity. Psychological stress contributes to LVH in African Americans and other populations. Objective This study evaluated the effects of stress reduction with the Transcendental Meditation (TM) technique on preventing LVH in African American adults with hypertension. Setting Martin Luther King Hospital - Charles R. Drew University of Medicine and Science, Los Angeles, CA. Method In this trial, 85 African American adults (average 52.8 years) were randomly assigned to either TM program or health education (HE) control group and completed posttesting. Participants were tested at baseline and after six months for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, psychosocial stress and behavioral factors. Change in outcomes was analyzed between groups by ANCOVA and within groups by paired t-test. Results The TM group had significantly lower LVMI compared with the HE group (-7.55gm/m 2 , 95% CI -14.78 to -.34 gm/m 2 , P=.040). Both interventions showed significant within group reductions in BP, (SBP/DBP changes for TM: -5/ -3 mm Hg, and for HE: -7/-6 mm Hg, P=.028 to <.001) although between group changes were not significant. In addition, both groups showed significant reductions in anger (P=.002 to .001). There were no other changes in lifestyle factors. Conclusions These findings indicate that stress reduction with TM was effective in preventing LVMI progression and thus may prevent LVH and associated CVD in high-risk African American patients.",2019,"The TM group had significantly lower LVMI compared with the HE group (-7.55gm/m 2 , 95% CI -14.78 to -.34 gm/m 2 , P=.040).","['\n\n\nAfrican Americans', 'African American adults with hypertension', 'Hypertensive African Americans', 'Left Ventricular Hypertrophy', 'high-risk African American patients', '85 African American adults (average 52.8 years', 'African Americans and other populations']","['Transcendental Meditation and Health Education', 'Transcendental Meditation (TM) technique', 'TM program or health education (HE) control group and completed posttesting']","['lifestyle factors', 'anger', 'BP, (SBP/DBP changes', 'LVMI', 'LVMI progression']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0150814', 'cui_str': 'Transcendental Meditation'}, {'cui': 'C0018701'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",85.0,0.0349591,"The TM group had significantly lower LVMI compared with the HE group (-7.55gm/m 2 , 95% CI -14.78 to -.34 gm/m 2 , P=.040).","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schneider', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Hector F', 'Initials': 'HF', 'LastName': 'Myers', 'Affiliation': 'Vanderbilt University, Vanderbilt Place, Nashville, Tennessee, USA.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Marwaha', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Rainforth', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Salerno', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Sanford I', 'Initials': 'SI', 'LastName': 'Nidich', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gaylord-King', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Charles N', 'Initials': 'CN', 'LastName': 'Alexander', 'Affiliation': 'Institute for Natural Medicine and Prevention, Maharishi University of Management, Fairfield, IA, USA.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Norris', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Ethnicity & disease,['10.18865/ed.29.4.577'] 314,32006590,Effects of the Combination of Atomoxetine and Oxybutynin on OSA Endotypic Traits.,"BACKGROUND We recently showed that administration of the combination of the noradrenergic drug atomoxetine plus the antimuscarinic oxybutynin (ato-oxy) prior to sleep greatly reduced OSA severity, likely by increasing upper airway dilator muscle activity during sleep. In patients with OSA who performed the ato-oxy trial with an esophageal pressure catheter to estimate ventilatory drive, the effect of the drug combination (n = 17) and of the single drugs (n = 6) was measured on the endotypic traits over a 1-night administration and compared vs placebo. This study also tested if specific traits were predictors of complete response to treatment (reduction in apnea-hypopnea index [AHI] > 50% and < 10 events/h). METHODS The study was a double-blind, randomized, placebo-controlled trial. The arousal threshold, collapsibility (ventilation at eupneic drive [Vpassive]), ventilation at arousal threshold, and loop gain (stability of ventilatory control, LG1), were calculated during spontaneous breathing during sleep. Muscle compensation (upper airway response) was calculated as a function of ventilation at arousal threshold adjusted for Vpassive. Ventilation was expressed as a percentage of the eupneic level of ventilation (% eupnea ). Data are presented as mean [95% CI]. RESULTS Compared with placebo, ato-oxy increased Vpassive by 73 [54 to 91]% eupnea (P < .001) and muscle compensation by 29 [8 to 51]% eupnea (P = .012), reduced the arousal threshold by -9 [-14 to -3]% (P = .022) and LG1 by -11 [-22 to 2]% (P = .022). Atomoxetine alone significantly reduced arousal threshold and LG1. Both agents alone improved collapsibility (Vpassive) but not muscle compensation. Patients with lower AHI, higher Vpassive, and higher fraction of hypopneas over total events had a complete response with ato-oxy. FINDINGS Ato-oxy markedly improved the measures of upper airway collapsibility, increased breathing stability, and slightly reduced the arousal threshold. Patients with relatively lower AHI and less severe upper airway collapsibility had the best chance for OSA resolution with ato-oxy.",2020,"Compared to placebo, ato-oxy increased Vpassive by 73[54 to 91]%eupnoea (p<0.001) and muscle compensation by 29[8 to 51]%eupnoea (p=0.012), reduced the arousal threshold by -9[-14 to -3]% (p=0.022) and LG1 by -11[-22 to 2]% (p=0.022).",['patients with OSA'],"['esophageal pressure catheter', 'atomoxetine', 'placebo', 'Atomoxetine and Oxybutynin', 'Atomoxetine']","['Muscle compensation (upper airway response', 'arousal threshold', 'breathing stability', 'collapsibility (Vpassive', 'Obstructive Sleep Apnea Endotypic Traits', 'arousal threshold and LG1', 'OSA resolution', 'muscle compensation', 'obstructive sleep apnea (OSA) severity', 'arousal threshold, collapsibility (ventilation at eupnoeic drive, Vpassive), ventilation at arousal threshold (Vactive) and loop gain (LG1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0232531', 'cui_str': 'Esophageal pressure (observable entity)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0069805', 'cui_str': 'oxybutynin'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]",,0.15495,"Compared to placebo, ato-oxy increased Vpassive by 73[54 to 91]%eupnoea (p<0.001) and muscle compensation by 29[8 to 51]%eupnoea (p=0.012), reduced the arousal threshold by -9[-14 to -3]% (p=0.022) and LG1 by -11[-22 to 2]% (p=0.022).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Taranto-Montemurro', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA. Electronic address: ltarantomontemurro@bwh.harvard.edu.""}, {'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Messineo', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA; Respiratory Medicine and Sleep Laboratory, Department of Internal Medicine, Spedali Civili di Brescia, University of Brescia, Brescia, Italy; Adelaide Institute for Sleep Health, Flinders University, Adelaide, SA, Australia.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azarbarzin', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Hess', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Calianese', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'White', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital & Harvard Medical School, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.01.012'] 315,30570787,"Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2-year double-blind, placebo-controlled, randomized trial plus 1-year open-label extension.","BACKGROUND Previous clinical trials with birch pollen subcutaneous immunotherapy have been conducted over a 1- to 2-year treatment period and involved mostly a single geographic location. OBJECTIVE This study (EudraCT-Number: 2005-000025-35) intended to evaluate the effect of subcutaneous immunotherapy with high-dose hypoallergenic birch pollen allergoid in patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3-year course in 19 European centres. METHODS Adults with confirmed birch pollen allergy (n = 253) were randomized to preseasonal placebo (n = 129) or active treatment (n = 124). Primary endpoint was change in Symptom Medication Score after 2 years treatment (2007). RESULTS The change in Symptom Medication Score of active- vs placebo-treated patients for the Full Analysis Set (n = 227, 15.2% reduction, P = 0.0710) and Per-Protocol Set (n = 216, 16.7% reduction, P = 0.0523) showed a positive trend, although significance was not achieved. The primary endpoint, assessed in 2007, coincided with the lowest pollination during the study period. In a subgroup analysis of patients in the north-eastern region (n = 102), where birch is the major tree and consequently patients' exposure is higher, changes in Symptom Medication Score (32.7% reduction, P = 0.0034) and median number of well days (P = 0.0232) were highly significant in favour of the active group. During the open-label third year of treatment, the mean Symptom Medication Score of active-treated patients was further reduced despite an increased pollen count. Subcutaneous immunotherapy was well tolerated and consistent with the known safety profile. CONCLUSIONS AND CLINICAL RELEVANCE Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north-eastern region of Europe, where birch is the predominant tree species. Proving efficacy of birch allergen subcutaneous immunotherapy is challenging due to the numerous factors influencing birch pollen allergen exposure in field studies.",2019,"Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north-eastern region of Europe, where birch is the predominant tree species.","['n\xa0', 'Adults with confirmed birch pollen allergy (n\xa0=\xa0253', 'patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3-year course in 19 European centres']","['placebo', 'preseasonal placebo', 'birch pollen allergoid subcutaneous immunotherapy', 'Subcutaneous immunotherapy', 'subcutaneous immunotherapy with high-dose hypoallergenic birch pollen allergoid']","['mean Symptom Medication Score', 'Symptom Medication Score of active', 'Efficacy and safety', 'Symptom Medication Score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1739388', 'cui_str': 'Birch pollen allergy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4047367', 'cui_str': 'Birch pollen'}, {'cui': 'C0051199', 'cui_str': 'Allergoid'}, {'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy (procedure)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",253.0,0.460236,"Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north-eastern region of Europe, where birch is the predominant tree species.","[{'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Rak', 'Affiliation': 'Asthma and Allergy Research Group, Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Boleslaw', 'Initials': 'B', 'LastName': 'Samoliński', 'Affiliation': 'Department of the Prevention of Environmental Hazards and Allergology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Antila', 'Affiliation': 'Ear, Nose and Throat Clinic, Terveystalo Hospital, Turku, Finland.'}, {'ForeName': 'Ann-Sofi', 'Initials': 'AS', 'LastName': 'Höiby', 'Affiliation': 'Asthma and Allergy Research Group, Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Kruse', 'Affiliation': 'Allergopharma GmbH & Co. KG, Reinbek, Germany.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Lipiec', 'Affiliation': 'Department of the Prevention of Environmental Hazards and Allergology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rudert', 'Affiliation': 'Allergopharma GmbH & Co. KG, Reinbek, Germany.'}, {'ForeName': 'Erkka', 'Initials': 'E', 'LastName': 'Valovirta', 'Affiliation': 'Department of Lung Diseases and Clinical Allergology, University of Turku, Turku, Finland.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13331'] 316,32243029,Effects of Health Belief Model based nursing interventions offered at home visits on lymphedema prevention in women with breast cancer: A randomised controlled trial.,"BACKGROUND Lymphedema is an important morbidity due to its physical and psychological restrictions and financial burden in women having breast cancer surgery. The study was performed to examine effects of Health Belief Model (HBM) based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery. DESIGN The study had an experimental design. METHODS The study included 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The sample was based on Consolidated Standard of Reporting Trials (CONSORT). Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at 3-month intervals. RESULTS HBM based nursing interventions regularly offered at home visits were found to create positive changes in behaviour of lymphedema prevention and improve upper extremity functions, reduce side-effects, relieve arm and breast symptoms, enhance the quality of life, increase self-efficacy and lower the frequency of lymphedema and costs. CONCLUSION The HBM based nursing interventions regularly offered at home visits can create positive changes in behaviour of lymphedema prevention and prevent lymphedema in women receiving radiotherapy after breast surgery. Considering costs of treatment for lymphedema, these interventions can be considered as cost-effective. RELEVANCE TO CLINICAL PRACTICE Nursing interventions directed towards behaviour of preventing lymphedema and follow-ups in the long-term should be supported by home visits and reminders through phone calls. Nurses should perform HBM based interventions regularly at home visits to prevent lymphedema. These interventions were found to reduce financial burden and were cost-effective.",2020,"RESULTS HBM based nursing interventions regularly offered at home visits were found to create positive changes in behaviour of lymphedema prevention and improve upper extremity functions, reduce side-effects, relieve arm and breast symptoms, enhance the quality of life, increase self-efficacy and lower the frequency of lymphedema and costs. ","['women with breast cancer', 'women having breast cancer surgery', 'women receiving radiotherapy after breast surgery', '72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group', 'women having breast surgery']","['Health Belief Model (HBM) based nursing interventions', 'Health Belief Model based nursing interventions']","['personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23', 'financial burden and cost-effective', 'frequency of lymphedema and costs', 'behaviour of lymphedema prevention and improve upper extremity functions, reduce side-effects, relieve arm and breast symptoms, enhance the quality of life, increase self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",72.0,0.0471121,"RESULTS HBM based nursing interventions regularly offered at home visits were found to create positive changes in behaviour of lymphedema prevention and improve upper extremity functions, reduce side-effects, relieve arm and breast symptoms, enhance the quality of life, increase self-efficacy and lower the frequency of lymphedema and costs. ","[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Cal', 'Affiliation': 'Department of Nursing, Ankara Medipol University School of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Zuhal', 'Initials': 'Z', 'LastName': 'Bahar', 'Affiliation': 'Department of Public Health Nursing, Okan University Faculty of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Gorken', 'Affiliation': 'Department of Radiation Oncology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.15271'] 317,31705728,"Tasuki for neck pain: An individually-randomized, open-label, waiting-list-controlled trial.","OBJECTIVES Neck pain ranks 4th highest in terms of disability as measured by years lived with disabilities. This study was conducted to determine whether Tasuki-style posture supporter improves neck pain compared to waiting-list. METHODS This trial was an individually-randomized, open-label, waiting-list-controlled study. Adults (20 years or older) with non-specific chronic neck pain who reported 10 points or more on modified Neck Disability Index (mNDI: range, 0-50; higher points indicate worse condition) were enrolled. Participants were randomly assigned 1:1 to the intervention group or waiting-list. Prespecified primary outcome was the change in mNDI at 1 week. The principle of intention-to-treat analyses (as randomized) was applied. This trial was prospectively registered with UMIN (UMIN000034825). RESULTS In total, 50 participants (mean age, 40.9 [standard deviation (SD) = 9.6]; 32 participants [64%] were female, mean mNDI, 14.3 [SD = 2.9]) were enrolled. Of these participants, 26 (52%) were randomly assigned to the intervention group and 24 (48%) to the waiting-list. Attrition rate was low in both groups (1/50). The mean mNDI change score at 1 week was more favorable for Tasuki than waiting-list (between-group difference, -3.5 points (95% confidence interval (CI), -5.3 to -1.8); P = .0002). More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)). CONCLUSION This trial suggests that wearing Tasuki might moderately improve neck pain. With its low-cost, low-risk, and easy-to-use nature, Tasuki could be an option for those who suffer from neck pain.",2020,"More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)). ","['Adults (20\xa0years or older) with non-specific chronic neck pain who reported 10 points or more on modified Neck Disability Index (mNDI: range', '50 participants (mean age, 40.9 [standard deviation (SD)\xa0=\xa09.6]; 32 participants [64%] were female, mean mNDI, 14.3 [SD\xa0=\xa02.9]) were enrolled', 'Tasuki for neck pain', 'years lived with disabilities']","['Tasuki-style posture supporter', 'intervention group or waiting-list']","['change in mNDI', 'moderate benefit', 'Attrition rate', 'neck pain', 'mean mNDI change score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.253504,"More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)). ","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Minami Seikyo Hospital, Nagoya, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12097'] 318,32198079,Improved monitoring of adherence with patching treatment using a microsensor and Eye Patch Assistant.,"BACKGROUND Use of a microsensor has been suggested to monitor patching adherence. Application has been limited because the microsensor's small size makes it easy to lose and a swallowing risk. We designed the Eye Patch Assistant (EPA) to hold the small microsensor in place and reduce the risk of loss or swallowing. This study reports the accuracy, precision, ease of use, and comfort for patching with EPA (patch+EPA) to monitor adherence. METHODS Adults (N = 13) wore an adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA and completed the questionnaire. Sensor sampling interval was every 5 minutes or every 1 minute. Sensor accuracy and precision were evaluated by Bland-Altman analysis and 95% limits of agreement, and questionnaire scores compared by Wilcoxon tests. RESULTS With 5-minute sampling, we found excellent accuracy for adults (mean actual vs recorded time difference, 1.4 minutes) and children (mean difference, -0.9 min). We found high precision for both adults and children (95% limits of agreement half widths of 6.4 minutes and 1.9 minutes, respectively). In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01). For children, scores did not differ significantly. The patch+EPA functioned well between 45° and 82°F. CONCLUSIONS The patch+EPA was well accepted and monitored adherence accurately and precisely.",2020,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).",['Adults (N = 13) wore an'],"['Eye Patch Assistant (EPA', 'adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA']","['comfort score', 'risk of loss or swallowing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]",,0.0380849,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).","[{'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Salus University Pennsylvania College of Optometry, Elkins Park, Pennsylvania. Electronic address: jingyun.wang@gmail.com.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Panorama Windows Ltd. New York, New York.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'De La Cruz', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Morale', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leske', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.01.006'] 319,31638334,Human urinary kallidinogenase or edaravone combined with butylphthalide in the treatment of acute ischemic stroke.,"AIM The effectiveness of neuroprotective agents is still unclear. Here we analyzed the clinical outcomes of acute ischemic stroke (AIS) patients treated with human urinary kallidinogenase (HUK) or edaravone (Eda) combined with butylphthalide (NBP). METHODS From January 2016 to December 2017, a total of 165 AIS patients were enrolled in this open-label, randomized controlled clinical study. Patients were randomly allocated into HUK group and Eda group in a ratio of 2:1. All the patients received basic treatments and NBP (200 mg p.o. qid) while HUK group received 0.15 PNA unit of HUK injection (ivgtt. qd) and Eda group received 30 mg Eda (ivgtt. bid) for 14 consecutive days. Independency rate [12-month modified Rankin Scale (mRS) score ≤ 1] and related factors were compared between the two groups. RESULTS Twelve-month mRS score of the HUK group (1, IQR 0~1) was significantly lower compared with Eda group (2, IQR 1~3, p < .0001). The HUK treatment achieved an independency rate of 79.1% while the Eda treatment only had 45.3% (p < .0001). Further binary logistic regression showed that recurrent stroke (RR: 0.1, 95% CI: 0.0~0.1, p = .038) and HUK treatment (RR: 4.2, 95% CI: 1.1~16.5, p = .041) could significantly affect patients' 12-month outcomes. CONCLUSION Human urinary kallidinogenase combined with NBP can enhance AIS patients' long-term independency rate, and the effectiveness of HUK combined therapy is better than Eda.",2019,"RESULTS Twelve-month mRS score of the HUK group (1, IQR 0~1) was significantly lower compared with Eda group (2, IQR 1~3, p < .0001).","['acute ischemic stroke', 'From January 2016 to December 2017, a total of 165 AIS patients']","['human urinary kallidinogenase (HUK) or edaravone (Eda) combined with butylphthalide (NBP', 'NBP', 'edaravone combined with butylphthalide', 'HUK', 'Eda group received 30\xa0mg Eda']","['recurrent stroke', 'independency rate', 'Independency rate [12-month modified Rankin Scale (mRS) score\xa0≤\xa01] and related factors']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0022478', 'cui_str': 'kallidinogenase'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.050183,"RESULTS Twelve-month mRS score of the HUK group (1, IQR 0~1) was significantly lower compared with Eda group (2, IQR 1~3, p < .0001).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': 'Department of Anesthesiology, Minhang Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minhai', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Nie', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}]",Brain and behavior,['10.1002/brb3.1438'] 320,31794968,"Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial.","BACKGROUND The innovative treatment model Improving Access to Psychological Therapies (IAPT) and its Norwegian adaptation, Prompt Mental Health Care (PMHC), have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. OBJECTIVE To investigate the effectiveness of the PMHC treatment compared to treatment as usual (TAU) at 6-month follow-up. METHODS A randomized controlled trial with parallel assignment was performed in two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalized Anxiety Disorder scale [GAD-7] scores above cutoff). These were randomly assigned (70:30 ratio; n = 463 to PMHC, n = 218 to TAU) with simple randomization within each site with no further constraints. The main outcomes were recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7) between baseline and follow-up. Primary outcome data were available for 73/67% in PMHC/TAU. Sensitivity analyses based on observed patterns of missingness were also conducted. Secondary outcomes were work participation, functional status, health-related quality of life, and mental well-being. RESULTS A reliable recovery rate of 58.5% was observed in the PMHC group and of 31.9% in the TAU group, equaling a between-group effect size of 0.61 (95% CI 0.37 to 0.85, p < 0.001). The differences in degree of improvement between PMHC and TAU yielded an effect size of -0.88 (95% CI -1.23 to -0.43, p < 0.001) for PHQ-9 and -0.60 (95% CI -0.90 to -0.30, p < 0.001) for GAD-7 in favor of PMHC. All sensitivity analyses pointed in the same direction, with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69). CONCLUSIONS The PMHC treatment was substantially more effective than TAU in alleviating the burden of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access to effective treatment for adults who suffer from anxiety and mild to moderate depression. A potential effect on work participation needs further examination.",2020,"PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69). ","['two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017', 'adults who suffer from anxiety and mild to moderate depression', 'Participants were 681 adults (aged ≥18 years']","['PMHC', 'TAU', 'Prompt Mental Health Care', 'IAPT']","['burden of anxiety and depression', 'recovery rate', 'recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7', 'work participation, functional status, health-related quality of life, and mental well-being', 'admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalized Anxiety Disorder scale [GAD-7] scores above cutoff']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",681.0,0.121467,"PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69). ","[{'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Knapstad', 'Affiliation': 'Faculty of Psychology, Department of Clinical Psychology, University of Bergen, Bergen, Norway, marit.knapstad@uib.no.'}, {'ForeName': 'Linn Vathne', 'Initials': 'LV', 'LastName': 'Lervik', 'Affiliation': 'Division of Mental and Physical Health, Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway.'}, {'ForeName': 'Solbjørg Makalani Myrtveit', 'Initials': 'SMM', 'LastName': 'Sæther', 'Affiliation': 'Division of Mental and Physical Health, Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway.'}, {'ForeName': 'Leif Edvard', 'Initials': 'LE', 'LastName': 'Aarø', 'Affiliation': 'Division of Mental and Physical Health, Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway.'}, {'ForeName': 'Otto Robert F', 'Initials': 'ORF', 'LastName': 'Smith', 'Affiliation': 'Division of Mental and Physical Health, Department of Health Promotion, Norwegian Institute of Public Health, Bergen, Norway.'}]",Psychotherapy and psychosomatics,['10.1159/000504453'] 321,31849170,The effects of walking intervention on preventing neck pain in office workers: A randomized controlled trial.,"OBJECTIVE This study aimed to evaluate the efficacy of increased daily walking steps on the 6-month incidence of neck pain among office workers. METHODS Healthy office workers with high risk of neck pain were recruited into a 6-month prospective cluster-randomized controlled trial. Participants were randomly assigned at the cluster level, into either intervention (n = 50) or control (n = 41) groups. Participants in the intervention group were instructed to increase their daily walking steps to a designated level for a duration of 6 months. Participants in the control group received no intervention. The outcome measures included the 6-month incidence of neck pain as well as its pain intensity and disability level. Analyses were performed using multivariable logistic regression model. RESULTS Of the participants in the intervention and control groups, 22% and 34% reported a 6-month incidence of neck pain, respectively. After adjusting for confounders, a significant preventive effect of walking intervention was found (adjusted odd ratio 0.22, 95% confidence interval 0.06-0.75). No significant difference in pain intensity and disability level was found between those in the intervention and control groups. CONCLUSION An intervention to increase daily walking steps reduced onset neck pain in high-risk office workers. However, the walking interventions did not decrease pain intensity and disability in those increasing the number of daily walking steps compared to the control group.",2020,"No significant difference in pain intensity and disability level was found between those in the intervention and control groups. ","['high-risk office workers', 'office workers', 'Healthy office workers with high risk of neck pain', 'neck pain among office workers']","['walking intervention', 'daily walking steps']","['neck pain', '6-month incidence of neck pain as well as its pain intensity and disability level', '6-month incidence of neck pain', 'pain intensity and disability', 'number of daily walking steps', 'pain intensity and disability level']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.0663582,"No significant difference in pain intensity and disability level was found between those in the intervention and control groups. ","[{'ForeName': 'Ekalak', 'Initials': 'E', 'LastName': 'Sitthipornvorakul', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Rattaporn', 'Initials': 'R', 'LastName': 'Sihawong', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pooriput', 'Initials': 'P', 'LastName': 'Waongenngarm', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Prawit', 'Initials': 'P', 'LastName': 'Janwantanakul', 'Affiliation': 'Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of occupational health,['10.1002/1348-9585.12106'] 322,31852704,"IMPACT study on intervening with a manualised package to achieve treatment adherence in people with tuberculosis: protocol paper for a mixed-methods study, including a pilot randomised controlled trial.","INTRODUCTION Compared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease. METHODS AND ANALYSIS This study uses a mixed-methods approach, with six study components. These are (1) scoping reviews of the literature; (2) qualitative research with patients, carers and healthcare professionals; (3) development of the intervention; (4) a pilot randomised controlled trial of the manualised intervention; (5) a process evaluation to examine clinical utility; and (6) a cost analysis. ETHICS AND DISSEMINATION This study received ethics approval on 24 December 2018 from Camberwell St. Giles Ethics Committee, UK (REC reference 18/LO/1818). Findings will be published and disseminated through peer-reviewed publications and conference presentations, published in an end of study report to our funder (the National Institute for Health Research, UK) and presented to key stakeholders. TRIAL REGISTRATION NUMBER ISRCTN95243114 SECONDARY IDENTIFYING NUMBERS: University College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK 16/88/06.",2019,"INTRODUCTION Compared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB).","['people with tuberculosis', 'University College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK']",['manualised package'],[],"[{'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0035168'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}]",[],,0.167373,"INTRODUCTION Compared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB).","[{'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Stagg', 'Affiliation': 'Centre for Global Health, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abubakar', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Colin Nj', 'Initials': 'CN', 'LastName': 'Campbell', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Centre for Pragmatic Global Health Trials, Institute of Global Health, University College London, London, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Darvell', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'UCL School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Kielmann', 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Heinke', 'Initials': 'H', 'LastName': 'Kunst', 'Affiliation': 'Department of Respiratory Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Mandelbaum', 'Affiliation': 'TB Alert, Brighton, UK.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Pickett', 'Affiliation': 'Department of Respiratory Medicine, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Story', 'Affiliation': 'Find&Treat, University College Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Vidal', 'Affiliation': 'Institute for Global Health and Development, Queen Margaret University Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Fatima B', 'Initials': 'FB', 'LastName': 'Wurie', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lipman', 'Affiliation': 'UCL Respiratory, University College London, London, UK marclipman@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-032760'] 323,32240909,Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial.,"BACKGROUND Preoperative chemoradiotherapy (CRT) followed by total mesorectal excision is widely accepted as the standard of care for high-risk rectal cancer. Adjuvant chemotherapy is advised in several international guidelines, although the survival benefit remains unclear and compliance is poor. The current multidisciplinary approach has led to major improvements in local control, yet the occurrence of distant metastases has not decreased accordingly. The combination of short-course radiotherapy (SCRT) and chemotherapy in the waiting period before surgery might have several benefits, including higher compliance, downstaging and better effect of systemic therapy. METHODS This is an investigator-initiated, international multicentre randomized phase III trial. High-risk rectal cancer patients were randomized to SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy (25-28 × 2-1.8 Gy) with concomitant capecitabine followed by surgery and optional postoperative chemotherapy (8 cycles CAPOX or 12 cycles FOLFOX4) according to local institutions' policy. The primary endpoint is time to disease-related treatment failure. Here, we report the compliance, toxicity and postoperative complications in both study groups. FINDINGS Between June 2011 and June 2016, 920 patients were enrolled. Of these, 901 were evaluable (460 in the experimental arm and 441 in the standard arm). All patients in the experimental arm received 5 × 5 Gy radiotherapy, and 84% of all patients received at least 75% of the prescribed chemotherapy. In the standard arm, the compliance for CRT was 94% and 57% for postoperative chemotherapy. Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy. No statistically significant differences in surgical procedures or postoperative complications were observed. INTERPRETATION High compliance (84%) of preoperative systemic treatment could be achieved with the experimental approach. Although considerable toxicity was observed during preoperative therapy, this did not lead to differences in surgical procedures or postoperative complications. Longer follow-up time is needed to assess the primary endpoint and related outcomes.",2020,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","['High-risk rectal cancer patients', 'high-risk rectal cancer ', 'Between June 2011 and June 2016, 920 patients were enrolled', '901 were evaluable (460 in the experimental arm and 441 in the standard arm']","['short-course radiotherapy', '5\xa0×\xa05 Gy radiotherapy', 'preoperative chemotherapy and surgery', 'short-course radiotherapy (SCRT) and chemotherapy', 'Adjuvant chemotherapy', 'Preoperative chemoradiotherapy (CRT', 'SCRT followed by chemotherapy (6 cycles CAPOX or alternatively 9 cycles FOLFOX4) and subsequent surgery, or long-course radiotherapy', 'concomitant capecitabine followed by surgery and optional postoperative chemotherapy']","['Toxicity ≥grade 3', 'time to disease-related treatment failure', 'Compliance and tolerability', 'compliance, toxicity and postoperative complications', 'toxicity', 'surgical procedures or postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",920.0,0.114836,"Toxicity ≥grade 3 occurred in 48% of patients in the experimental arm, compared to 25% of patients in the standard arm during preoperative treatment and 35% of patients during postoperative chemotherapy.","[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Center, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Elma Meershoek-Klein', 'Initials': 'EM', 'LastName': 'Kranenbarg', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO). Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Center Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.03.011'] 324,32297383,Simplified method for the measurement of plasma alkylresorcinols: Biomarkers of whole-grain intake.,"RATIONALE Consumption of whole grains is negatively associated with cardiovascular disease (CVD) risk but quantification of whole-grain intake is challenging. Alkylresorcinols (ARs) are biomarkers of whole-grain intake. Current methods for AR quantification involve a time-consuming multi-step separation process that hampers applicability in large-scale studies. METHODS We developed a streamlined method to quantify ARs in human plasma based on protein precipitation and direct injection into an ultra-high-performance liquid chromatograph coupled to a quadrupole time-of-flight mass spectrometer operating in atmospheric pressure chemical ionization negative ion mode. RESULTS Separation of five major ARs was achieved, with linearity in the 5 to 550 nmol/L range and a lower limit of detection (LOD) of 0.5 nmol/L and quantification (LOQ) of 5 nmol/L. The within-run and between-run precision and accuracy were below 15%, and recoveries above 90%. Once validated, the method was applied to measure concentrations of plasma ARs in subjects who participated in a randomized, crossover trial evaluating the effect of carbohydrate type on CVD risk factors. The unrefined carbohydrate diet with the highest fiber content resulted in the highest plasma AR concentration (93 ± 78 nmol/L), and was significantly different (p <0.01) from lower fiber diets (18 ± 26 nmol/L and 19 ± 26 nmol/L, simple and unrefined carbohydrate, respectively). CONCLUSIONS This method offers a simplified approach to measure concentrations of plasma ARs as an objective biomarker of whole-grain intake that can be applied to large-scale cohort studies.",2020,"The unrefined-carbohydrate diet with the highest fiber content resulted in the highest plasma AR concentration (93±78 nmol/L), and was significantly different (p<0.01) from lower fiber diets (18±26 nmol/L and 19±26 nmol/L, simple and unrefined-carbohydrate, respectively). ",[],[],"['limit of detection of 0.5 nmol/L (LOD) and quantification (LOQ', 'Plasma Alkylresorcinols', 'highest plasma AR concentration']",[],[],"[{'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0175411,"The unrefined-carbohydrate diet with the highest fiber content resulted in the highest plasma AR concentration (93±78 nmol/L), and was significantly different (p<0.01) from lower fiber diets (18±26 nmol/L and 19±26 nmol/L, simple and unrefined-carbohydrate, respectively). ","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodríguez-Morató', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jayawardene', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Huang', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Dolnikowski', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Galluccio', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington Street, Boston, MA, 02111, USA.'}]",Rapid communications in mass spectrometry : RCM,['10.1002/rcm.8805'] 325,32221989,The project REBOOT protocol: Evaluating a personalized inhibitory control training as an adjunct to cognitive behavioral therapy for bulimia nervosa and binge-eating disorder.,"Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal. One potential explanation is that CBT fails to adequately target inhibitory control (i.e., the ability to withhold an automatic response), which is a key maintenance factor for binge eating. Computerized inhibitory control training (ICT) is a promising method for improving inhibitory control but is relatively untested in BN/BED. The present study will evaluate a computer-based ICT as an adjunct to CBT for BN/BED. Participants with BN (n = 30) or BED (n = 30) will be randomized to 12 weeks of either CBT + ICT or CBT + a sham training. Trainings will be completed daily for 4 weeks and weekly for 8 weeks. Primary aims include the following: (a) confirm target engagement (evaluate whether ICT improves inhibitory control), (b) test target validation (evaluate whether improvements in inhibitory control are associated with improvements in binge eating), and (c) evaluate the incremental efficacy of ICT on binge eating. Secondary aims include the following: (a) evaluate ICT feasibility and acceptability and (b) assess the moderating effects of approach tendencies on highly palatable food, dietary restraint, and diagnosis. Data will be used to shape a fully powered clinical trial designed to assess efficacy and dose-response effects of ICT for BN/BED.",2020,Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal.,"['Participants with BN (n = 30) or BED (n = 30', 'bulimia nervosa and binge-eating disorder', 'bulimia nervosa (BN) and binge-eating disorder (BED']","['personalized inhibitory control training', 'cognitive behavioral therapy (CBT', 'Computerized inhibitory control training (ICT', 'cognitive behavioral therapy', 'CBT\u2009+\u2009ICT or CBT\u2009+\u2009a sham training']","['binge eating), and (c) evaluate the incremental efficacy of ICT on binge eating', 'ICT feasibility and acceptability and (b) assess the moderating effects of approach tendencies on highly palatable food, dietary restraint, and diagnosis']","[{'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",30.0,0.043429,Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal.,"[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Lampe', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Gillikin', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Payne-Reichert', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}]",The International journal of eating disorders,['10.1002/eat.23225'] 326,32202830,The impact of primary care behavioral health services on patient behaviors: A randomized controlled trial.,"INTRODUCTION Greater understanding of the impact of low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP) may promote better depression care. METHOD In a randomized controlled trial, 153 participants identified as depressed by their primary care provider (PCP) were assigned to ICP or usual care (UC, management by PCP, including specialty referral). In the ICP condition, BHCs worked collaboratively with PCPs and liaison psychiatrists. RESULTS ICP participants with lower and higher severity symptoms reported significantly greater use of coping strategies than UC participants at the 1-month follow up (lower: p = .002; higher: p = .016). ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups. ICP participants were more likely to be following relapse preventions plans at the 4-month follow up (lower: 89.5% vs. 50%, p = .0.000; higher 74.1% vs. 33%, p = .0001). ICP participants also reported use of antidepressant medications on more days than UC participants at the 4-month follow up (lower: 21.27 vs. 14.49 days, p = .049; higher: 24.61 vs. 17.08 days, p = .035). Patient retention in the ICP was high, and ICP participants were significantly more satisfied with depression care than UC participants at follow-up assessments. DISCUSSION Delivery of low intensity psychosocial interventions by BHCs was associated with improvements to behavior charge targets. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups.","['patient behaviors', '153 participants identified as depressed by their primary care provider (PCP']","['ICP or usual care (UC, management by PCP, including specialty referral', 'ICP', 'low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP', 'primary care behavioral health services']","['coping strategies', 'relapse preventions plans']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]","[{'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]",153.0,0.0617056,"ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Robinson', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Von Korff', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Bush', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Elizabeth H B', 'Initials': 'EHB', 'LastName': 'Lin', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}, {'ForeName': 'Evette J', 'Initials': 'EJ', 'LastName': 'Ludman', 'Affiliation': 'Group Health Cooperative Center for Health Studies.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000474'] 327,32165270,Portion size selection in children: Effect of sensory imagery for snacks varying in energy density.,"Food sensory imagery - creating a vivid mental image of the sensory experience of eating - can lead to the selection of smaller portions because it serves as a reminder that eating enjoyment does not necessarily increase with portion size. The evidence is mostly limited to adults and to energy-dense foods for which it is particularly difficult to predict the satiating effects of consumption quantity. The objective was to study how food sensory imagery influences portion size selection of foods varying in energy density (brownie and applesauce) by 7- to 11-year-old children. During after-school time, 171 children were randomized into two conditions. Children in the food sensory imagery condition were asked to imagine the taste, smell, and texture of eating palatable foods, i.e., chocolate cereal, chocolate waffle, and chocolate candies. Children in the control condition performed a similar sensory imagery task for non-food-related activities. Children were then asked to choose between the recommended serving size, a 50% larger portion, and a 125% larger portion of either brownie or applesauce. One week later, they were placed in the same condition for the other food. Compared to the control condition, food sensory imagery led children to choose 7.1% less brownie but had no effect on applesauce portion selection. Exploratory findings showed that the food sensory imagery intervention was especially effective at reducing brownie portion size selection among children who were moderately hungry, who usually eat fast, and whose parents pressure them to eat. In conclusion, food sensory imagery may be a useful intervention to nudge children towards healthier portion size choices because it reduces the selected portion size of an energy-dense snack without reducing the selected portion size of a healthier snack.",2020,"Compared to the control condition, food sensory imagery led children to choose 7.1% less brownie but had no effect on applesauce portion selection.","['171 children', 'foods varying in energy density (brownie and applesauce) by 7- to 11-year-old children', 'children']",['food sensory imagery intervention'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1720240', 'cui_str': 'Applesauce'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}]",[],171.0,0.0383796,"Compared to the control condition, food sensory imagery led children to choose 7.1% less brownie but had no effect on applesauce portion selection.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lange', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: christine.lange@inrae.fr.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Hachefa', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France; INSEAD, F-77300, Fontainebleau, France.""}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Cornil', 'Affiliation': 'UBC Sauder, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chandon', 'Affiliation': 'INSEAD, F-77300, Fontainebleau, France.'}]",Appetite,['10.1016/j.appet.2020.104656'] 328,31135552,Small Social Incentives Did Not Improve the Survey Response Rate of Patients Who Underwent Orthopaedic Surgery: A Randomized Trial.,"BACKGROUND The generalizability of data derived from patient-reported outcome measures (PROMs) depends largely on the proportion of the relevant population that completes PROM surveys. However, PROM survey responses remain low, despite efforts to increase participation. Social incentives, such as the offer to make a charitable donation on behalf of the survey respondent, have generally not been effective where online surveys are concerned, but this has not been extensively tested in medicine. QUESTIONS/PURPOSES (1) Do personalized social incentives increase response rates or response completeness for postoperative PROM surveys in an orthopaedic population? (2) Are there demographic factors associated with response and nonresponse to postoperative PROM surveys? (3) Are some demographic factors associated with increased response to social incentive offers? METHODS Participants were selected from an institutional orthopaedics database. Patients were older than 18 years, had an email address on file, and had undergone one of the following procedures 1 to 2 years ago: Achilles tendon repair, ACL reconstruction, meniscectomy, hip arthroscopy, TKA, or THA. Of 4685 eligible patients, 3000 (64%) were randomly selected for inclusion in the study. Participants were randomized to one of four groups: (1) control: no incentive (n = 750); (2) patient donation: offer of a USD 5 donation to provide medical supplies to a pediatric orthopaedic patient (n = 751); (3) research donation: offer of a USD 5 donation to a procedure-specific research program (n = 749); or (4) explanation: explanation that response supports quality improvement (n = 750). The four groups did not differ regarding patient age, gender, race, procedure type, or time since procedure. All patients were sent an email invitation with the same PROM survey link. The proportion of patients who responded (defined here as the response rate) was measured at 4 weeks and compared between intervention groups. We used a logistic regression analysis to identify demographic factors associated with response while controlling for confounding variables and performed subgroup analyses to determine any demographic factors associated with increased response to social incentives. RESULTS There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups. Women (odds ratio [OR], 1.175; p = 0.042), older patients (< 58 years: OR, 1.016 per 1-year increase; p = 0.001; 58-64 years: OR, 1.023 per 1-year increase; p < 0.001; > 64 years: OR, 1.021 per 1-year increase; p < 0.001), and white patients (OR 2.034 compared with black patients, p < 0.001) were slightly more likely to respond, after controlling for potential confounding variables such as gender, age, race, and procedure type. In subgroup analyses, men (research donation: 49% [155 of 316], patient donation: 45% [146 of 328], control: 40% [130 of 325], explanation: 39% [127 of 325]; p = 0.041) and patients younger than 58 years (research donation: 40% [140 of 351], control: 35% [130 of 371], patient donation: 32% [113 of 357], explanation: 27% [93 of 340]; p = 0.004) were slightly more likely to respond to the research donation than those with other interventions were. CONCLUSIONS Despite small effects in specific subgroups, personalized social incentives did not increase the overall response to postoperative orthopaedic surveys. Novel and targeted strategies will be necessary to reach response thresholds that enable healthcare stakeholders to use PROMs effectively. LEVEL OF EVIDENCE Level I, therapeutic study.",2019,"There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups.","['4685 eligible patients, 3000 (64%) were randomly selected for inclusion in the study', 'Participants were selected from an institutional orthopaedics database', 'patients younger than 58 years (research donation: 40% [140 of 351], control: 35% [130 of 371], patient donation: 32% [113 of 357], explanation: 27% [93 of 340]; p = 0.004) were slightly more likely to respond to the research donation than those with other interventions were', 'All patients were sent an email invitation with the same PROM survey link', 'Patients were older than 18 years, had an email address on file, and had undergone one of the following procedures 1 to 2 years ago']","['Orthopaedic Surgery', 'USD 5 donation to a procedure-specific research program (n = 749); or (4) explanation: explanation that response supports quality improvement', 'control: no incentive (n = 750); (2) patient donation: offer of a USD 5 donation to provide medical supplies to a pediatric orthopaedic patient (n = 751); (3) research donation']","['Achilles tendon repair, ACL reconstruction, meniscectomy, hip arthroscopy, TKA, or THA', 'overall response rate', 'response rate', 'Survey Response Rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",4685.0,0.063268,"There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups.","[{'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Warwick', 'Affiliation': 'H. Warwick, C. Hutyra, C. Politzer, A. Francis, T. Risoli, Jr, C. Green, R. C. Mather III, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA N. Verma, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA S. Huettel, Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hutyra', 'Affiliation': ''}, {'ForeName': 'Cary', 'Initials': 'C', 'LastName': 'Politzer', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Risoli', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Huettel', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000732'] 329,32289541,Online Education Is Non-Inferior to Group Education for Irritable Bowel Syndrome: A Randomized Trial and Patient Preference Trial.,"BACKGROUND & AIMS Structured education can reduce symptoms in patients with irritable bowel syndrome (IBS), but the availability of such interventions is limited and online formats could facilitate their dissemination. We compared the effectiveness of Internet-delivered vs face-to-face education in patients with IBS, hypothesizing that the online format would not be inferior. METHODS We conducted 2 trials of Internet-delivered vs face-to-face group education (3 weeks) at a gastroenterology outpatient clinic in Sweden. In the first trial, 141 patients with IBS were assigned randomly (1:1) to either Internet-delivered or face-to-face education, from August 2016 through June 2017. In the second trial, 155 patients with IBS were allowed to choose whether to receive education via the Internet or face to face, from August 2017 through September 2018. Patients completed questionnaires before, during, and after education. The primary outcome measure was the irritable bowel severity scoring system, which measures IBS severity on a scale from 0 to 500, based on abdominal pain, bloating, dissatisfaction with bowel habits, and interference with life. The primary test of noninferiority adhered to the intent-to-treat principle and concerned the difference in change up to 6 months after education, tested using the 1-sided CI for the time by group interaction in a linear mixed model fitted on data from the randomized controlled trial. A secondary per-protocol analysis used data from all treatment completers in both trials. The noninferiority margin was 40 points on the irritable bowel severity scoring system. RESULTS In the primary analysis, patients who received face-to-face education had an average reduction in irritable bowel severity score that was 12.2 points more than that of patients who received Internet education (1-sided 95% CI upper bound, 38.4). In the per-protocol analysis, patients who received face-to-face education reduced their average irritable bowel severity score by 14.7 points more than patients who received Internet education (95% CI upper bound, 35.5). Face-to-face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred Internet-delivered education. Between-group effects on secondary symptoms were small. CONCLUSIONS Based on the comparison of Internet-delivered vs face-to-face education for IBS, the upper bound of the CI for the difference in change up to 6 months after education was within the noninferiority margin of 40 points. We therefore conclude that Internet-delivered education is noninferior to face-to-face education. Future research should focus on increasing within-group effects. ClinicalTrials.gov no: NCT03466281.",2020,"Face to face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred internet-delivered education.","['patients with irritable bowel syndrome (IBS', '155 patients with IBS', '3 weeks) at a gastroenterology outpatient clinic in Sweden', '141 patients with IBS', 'Irritable Bowel Syndrome', 'patients with IBS']","['internet-delivered vs face to face group education', 'internet-delivered or face to face education', 'internet-delivered vs face to face education']","['irritable bowel severity score', 'irritable bowel severity scoring system, which measures IBS severity on a scale from 0 to 500, based on abdominal pain, bloating, dissatisfaction with bowel habits, and interference with life', 'self-rated knowledge', 'average irritable bowel severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",141.0,0.112174,"Face to face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred internet-delivered education.","[{'ForeName': 'Perjohan', 'Initials': 'P', 'LastName': 'Lindfors', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Sollentuna Specialistklinik, Stockholm, Sweden. Electronic address: perjohan.lindfors@ki.se.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Engstrand', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Störsrud', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Jerlstad', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Törnblom', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Functional Gastrointestinal and Motility Disorders, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Ringström', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.005'] 330,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance. SUBJECTS/METHODS Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months. RESULTS At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant. CONCLUSIONS Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant. ","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant. ","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x'] 331,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores. SUBJECTS/METHODS In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants. RESULTS Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months. CONCLUSIONS Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4'] 332,31362541,Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome.,"BACKGROUND The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. METHODS In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). RESULTS Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years' follow-up (median [interquartile range], 744 [570-853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. CONCLUSIONS More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.",2019,"Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. ","['non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals', '17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group', 'patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes', 'Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29', 'Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome', 'Medically stabilized patients', 'non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts']","['percutaneous coronary intervention', 'routine invasive management', 'invasive management (invasive group) or noninvasive management (medical group', 'Invasive Versus Medical Management', 'invasive versus noninvasive management']","['composite safety outcome', 'composite outcome for efficacy', 'serious adverse event', 'efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function', 'Health status (EuroQol 5 Dimensions) and angina class', 'efficacy or safety outcome']","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",217.0,0.0626605,"Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. ","[{'ForeName': 'Matthew M Y', 'Initials': 'MMY', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Corcoran', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Ammani', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., A.B., M.B.M., A.S., A.P.R., C.B.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Cialdella', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Novalia P', 'Initials': 'NP', 'LastName': 'Sidik', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Margaret B', 'Initials': 'MB', 'LastName': 'McEntegart', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Rae', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Stuart H M', 'Initials': 'SHM', 'LastName': 'Hood', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Peat', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Iain N', 'Initials': 'IN', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Cormack', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Nikolay B', 'Initials': 'NB', 'LastName': 'Bukov', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, United Kingdom (N.B.B., K.P.B.).'}, {'ForeName': 'Kanarath P', 'Initials': 'KP', 'LastName': 'Balachandran', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, United Kingdom (N.B.B., K.P.B.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics (I.F., A.M.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': 'Health Economics and Health Technology Assessment (O.W.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics (I.F., A.M.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Sarah J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, University of Strathclyde, United Kingdom (S.J.E.B.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.007830'] 333,32279919,Impact of left ventricular assist device implantation on mitral regurgitation: An analysis from the MOMENTUM 3 trial.,"BACKGROUND Mitral regurgitation (MR) determines pathophysiology and outcome in advanced heart failure. The impact of left ventricular assist device (LVAD) placement on clinically significant MR and its contribution to long-term outcomes has been sparsely evaluated. METHODS We evaluated the effect of clinically significant MR on patients implanted in the MOMENTUM 3 trial with either the HeartMate II (HMII) or the HeartMate 3 (HM3) at 2 years. Clinical significance was defined as moderate or severe grade MR determined by site-based echocardiograms. RESULTS Of 927 patients with LVAD implants without a prior or concomitant mitral valve procedure, 403 (43.5%) had clinically significant MR at baseline. At 1-month of support, residual MR was present in 6.2% of patients with HM3 and 14.3% of patients with HMII (relative risk = 0.43; 95% CI, 0.22-0.84; p = 0.01) with a low rate of worsening at 2 years. Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD. The presence or absence of baseline MR did not influence mortality (HM3 HR, 0.86; 95% CI, 0.56-1.33; p = 0.50; HMII HR, 0.81; 95% CI, 0.54-1.22; p = 0.32), major adverse events or functional capacity. In multivariate analysis, severe baseline MR (p = 0.001), larger left ventricular dimension (p = 0.002), and implantation with the HMII instead of the HM3 LVAD (p = 0.05) were independently associated with an increased likelihood of persistent MR post-implant. CONCLUSIONS Hemodynamic unloading after LVAD implantation improves clinically significant MR early, sustainably, and to a greater extent with the HM3 LVAD. Neither baseline nor residual MR influence outcomes after LVAD implantation.",2020,"Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD.","['advanced heart failure', '927 patients with LVAD implants', 'mitral regurgitation']","['left ventricular assist device implantation', 'LVAD implantation', 'left ventricular assist device (LVAD) placement']","['larger left ventricular dimension', 'severe baseline MR', 'residual MR', 'major adverse events or functional capacity', 'Residual MR', 'moderate or severe grade MR']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",927.0,0.19855,"Residual MR at 1-month post-implant did not impact 2-year mortality for either the HM3 (hazard ratio [HR],1.41; 95% CI, 0.52-3.89; p = 0.50) or HMII (HR, 0.91; 95% CI, 0.37-2.26; p = 0.84) LVAD.","[{'ForeName': 'Manreet K', 'Initials': 'MK', 'LastName': 'Kanwar', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Keshava', 'Initials': 'K', 'LastName': 'Rajagopal', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, Texas.""}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Silvestry', 'Affiliation': 'AdventHealth Transplant Institute, Orlando, Florida.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Salerno', 'Affiliation': 'St Vincent Heart Center, Indianapolis, Indiana.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Horstmanshof', 'Affiliation': 'INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Montefiore Einstein Center for Heart and Vascular Care, New York, New York.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Gregoric', 'Affiliation': ""The University of Texas Health Science Center at Houston and Memorial Hermann Hospital's Heart & Vascular Institute, Houston, Texas.""}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Chuang', 'Affiliation': 'Abbott, Abbott Park, Illinois.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott, Abbott Park, Illinois.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: mmehra@bwh.harvard.edu.""}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.03.003'] 334,32282934,"Intervention study to evaluate the importance of information given to patients with contact allergy: a randomized, investigator-blinded clinical trial.","BACKGROUND In contact dermatitis, it is crucial to understand and remember the outcome of patch testing. Unfortunately, many patients do not remember the results of their patch tests. OBJECTIVES Our aim was to evaluate the effects of an intervention programme in which extensive information on specific contact allergy was provided, in individuals with positive patch test reactions. METHODS The study was designed as a randomized, investigator-blinded clinical trial. Participants with positive test reactions were randomized into two groups that received either standard information according to clinical routine or standard information and a reminder letter. Knowledge of contact allergies was evaluated using questionnaires 12 months after inclusion. RESULTS There were 184 adults included in the trial and the response rate at 1-year follow-up was 78% (143 of 184). Sixty-five per cent (45 of 69) in the intervention group and 54% (40 of 74) in the control group reported the correct name of the allergen (P = 0·23). Participants with several - as opposed to few - positive patch test reactions had difficulty in remembering the correct names of the allergens (P = 0·001). Moreover, the type of allergy had an influence on their ability to remember the name of the allergen correctly and their ability to make changes in lifestyle. CONCLUSIONS The intervention performed did not significantly affect the participants' ability to remember their contact allergy. To achieve better knowledge and changes in lifestyle, efforts to inform should concentrate on individuals with several positive patch test reactions, those with particular allergens, individuals over 60 years of age, and - concerning changes in lifestyle - males. What is already known about this topic? Patch testing is crucial for patients with contact dermatitis. The ability to remember and understand the outcome of the patch testing is fundamental. Unfortunately, many patients do not remember or have misunderstood the results of their patch tests. Patients who require more information should be identified. What does this study add? This study suggests that participants' ability to remember and understand their patch test results, and also to make changes in lifestyle, are dependent on factors such as the number of contact allergies, which allergy they have, age and sex. The results highlight the importance of making further efforts to gain higher efficacy in the information and education given. It is therefore valuable to take special care with these patients and to cautiously educate and inform them about the results of patch tests.",2020,The performed intervention did not significantly affect the participants' ability to remember their contact allergy.,"['One hundred and eighty-four adults were included in the trial and the response rate at one-year follow-up was 78% (143/184', 'Patients with Contact Allergy', 'individuals with positive patch test reactions', 'Participants with positive test reactions']","['standard information according to clinical routine or standard information and a reminder letter', 'intervention programme']","[""participants' ability to remember their contact allergy""]","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162820', 'cui_str': 'Allergic contact dermatitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030646', 'cui_str': 'Patch test'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C0162820', 'cui_str': 'Allergic contact dermatitis'}]",184.0,0.0913612,The performed intervention did not significantly affect the participants' ability to remember their contact allergy.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dizdarevic', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Troensegaard', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Uldahl', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bergendorff', 'Affiliation': 'Department of Occupational and Environmental Dermatology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Siemund', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Å', 'Initials': 'Å', 'LastName': 'Svensson', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sonesson', 'Affiliation': 'Department of Dermatology and Venereology, Skåne University Hospital, Malmö, Sweden.'}]",The British journal of dermatology,['10.1111/bjd.19119'] 335,29866011,Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; Α Randomised Clinical Trial.,"BACKGROUND Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) and ischaemic stroke but with less bleeding events. OBJECTIVE We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a cyclooxygenase-1 (COX-1) inhibitor. METHODS Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin 100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints were the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria. RESULTS At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to 3.5) and lied within the a-priori defined equivalence interval (p<0.001). Regarding the primary safety endpoints, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2). CONCLUSION The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin when administered for 12 months. Importantly, triflusal significantly reduced the incidence of ΜΙ and showed a better safety profile compared with aspirin. (ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS trial; Clinical Trials.gov Identifier: NCT02616497).",2019,"Regarding the primary safety end points, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2). ","['Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke', 'patients eligible to receive a', 'patients with acute myocardial infarction (ΜΙ) and ischaemic stroke']","['triflusal versus aspirin', 'cyclooxygenase-1', 'aspirin', 'ASpirin versus Triflusal for Event Reduction', 'Aspirin', 'triflusal 300 mg twice or 600 mg once daily or aspirin']","['rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria', 'efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference', 'composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period', 'develop bleeding events', 'Atherothrombotic Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0077126', 'cui_str': 'triflusal'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0389003', 'cui_str': 'Cyclo-Oxygenase I'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0035168'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.265222,"Regarding the primary safety end points, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2). ","[{'ForeName': 'Kallirroi I', 'Initials': 'KI', 'LastName': 'Kalantzi', 'Affiliation': 'Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Ioannis V', 'Initials': 'IV', 'LastName': 'Ntalas', 'Affiliation': 'Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Vasileios G', 'Initials': 'VG', 'LastName': 'Chantzichristos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Tsoumani', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Adamopoulos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Asimakopoulos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Adamantios', 'Initials': 'A', 'LastName': 'Bourdakis', 'Affiliation': 'Internal Medicine, Diabetes and Metabolism Unit, Trikala General Hospital, Trikala, Greece.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Darmanis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dimitriadou', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Gkiokas', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Ipeirotis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Kitikidou', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Klonaris', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Aglaia', 'Initials': 'A', 'LastName': 'Kostaki', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Logothetis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Mainas', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Mais', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maragiannis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Martiadou', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Mavronasos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Michelongonas', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Mitropoulos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Papadimitriou', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Achilleas', 'Initials': 'A', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Miltiadis', 'Initials': 'M', 'LastName': 'Papaioakeim', 'Affiliation': 'Department of Internal Medicine, General Hospital of Komotini, Komotini, Greece.'}, {'ForeName': 'Kosmas', 'Initials': 'K', 'LastName': 'Sofillas', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Stabola', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stefanakis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stergiou', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Thoma', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Zenetos', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Zisekas', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Goudevenos', 'Affiliation': 'Department of Cardiology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Demosthenes B', 'Initials': 'DB', 'LastName': 'Panagiotakos', 'Affiliation': 'School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Alexandros D', 'Initials': 'AD', 'LastName': 'Tselepis', 'Affiliation': 'Department of Chemistry, Atherothrombosis Research Centre, University of Ioannina, Ioannina, Greece.'}]",Current vascular pharmacology,['10.2174/1570161116666180605090520'] 336,31968400,Comparison of Allen Carr's Easyway programme with a specialist behavioural and pharmacological smoking cessation support service: a randomized controlled trial.,"BACKGROUND AND AIMS A combination of behavioural and pharmacological support is judged to be the optimal approach for assisting smoking cessation. Allen Carr's Easyway (ACE) is a single-session pharmacotherapy-free programme that has been in operation internationally for 38 years. We compared the effectiveness of ACE with specialist behavioural and pharmacological support delivered to the national standard in England. DESIGN A two-arm, parallel-group, single-blind, randomized controlled trial. SETTING London, UK, between February 2017 and May 2018. PARTICIPANTS A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition) were included in the analysis. Adult (≥ 18 years) smokers wanting to quit were randomized in a 1 : 1 ratio. Mean age for the total sample was 40.8 years, with 53.4% being male. Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence) were evenly balanced between treatment groups. INTERVENTION AND COMPARATOR The intervention was the ACE method of stopping smoking. This centres on a 4.5-6-hour session of group-based support, alongside subsequent text messages and top-up sessions if needed. It aims to make it easy to stop smoking by convincing smokers that smoking provides no benefits for them. The comparator was a specialist stop smoking service (SSS) providing behavioural and pharmacological support in accordance with national standards. MEASUREMENTS The primary outcome was self-reported continuous abstinence for 26 weeks from the quit/quit re-set date verified by exhaled breath carbon monoxide measurement < 10 parts per million (p.p.m.). Primary analysis was by intention to treat. Secondary outcomes were: use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12 weeks. FINDINGS A total of 468 participants attended treatment (255 ACE versus 213 SSS, P < 0.05). Of those who did attend treatment, 100 completed 6-month measures (23.7% ACE versus 20.7% SSS). Continuous abstinence to 26 weeks was 19.4% (60 of 310) in the ACE intervention and 14.8% (46 of 310) in the SSS intervention [risk difference for ACE versus SSS 4.5% (95% confidence interval (CI) = -1.4 to 10.4%, odds ratio (OR) = 1.38)]. The Bayes factor for superiority of the ACE condition was 1.24. CONCLUSION There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.",2020,There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.,"['Mean age for the total sample was 40.8\xa0years, with 53.4% being male', '468 participants attended treatment (255 ACE versus 213 SSS, P\xa0<\xa00.05', 'A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition', 'London, UK, between February 2017 and May 2018', 'Adult (≥ 18\xa0years) smokers wanting to quit']","['ACE', 'specialist behavioural and pharmacological smoking cessation support service']","['Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence', 'use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12\xa0weeks', 'self-reported continuous abstinence for 26\xa0weeks from the quit/quit re-set date verified by exhaled breath carbon monoxide measurement']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0201932', 'cui_str': 'Carboxyhemoglobin measurement (procedure)'}]",468.0,0.167735,There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Frings', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Albery', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Antony C', 'Initials': 'AC', 'LastName': 'Moss', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brunger', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Meda', 'Initials': 'M', 'LastName': 'Burghelea', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Kerry V', 'Initials': 'KV', 'LastName': 'Wood', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14897'] 337,31710994,Individual differences in human opioid abuse potential as observed in a human laboratory study.,"BACKGROUND Opioids have high abuse potential and pose a major public health concern. Yet, a large percentage of individuals exposed to opioids do not develop problematic use. Individual differences in opioid abuse potential are not well understood. METHODS This within-subject (N = 16), double-blind, double-dummy, human laboratory study evaluated individual differences in response to dose (placebo, low, medium, high) following administration of heroin and hydromorphone through intravenous and subcutaneous routes, in opioid-experienced but non physically-dependent participants. Outcomes were self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire. The degree to which results were consistent across measures within an individual was assessed using a mixed-effects model from which an intraclass correlation coefficient measure of between and within-subject variance was derived. RESULTS The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent. Visual inspection reveals a myriad response pattern across participants, with some demonstrating classic dose-effect responses and others not differentiating any active doses from placebo. CONCLUSIONS Data suggest the abuse potential of opioids is significantly different between individuals but that the experience within an individual is highly consistent. Research to prospectively characterize and evaluate mechanisms underlying these differences is warranted and may provide a foundation to help identify persons at heightened risk of transitioning from opioid exposure to misuse and/or opioid use disorder.",2019,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.",[],['heroin and hydromorphone'],"['self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire']",[],"[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.212725,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dunn', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States. Electronic address: kdunn9@jhmi.edu.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': 'Health Canada, Canada; Centre for Addiction and Mental Health, Canada; University of Toronto, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, Canada.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107688'] 338,29978597,Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition.,"BACKGROUND The catheter lock solutions 2% taurolidine and 0.9% saline are both used to prevent catheter-related bloodstream infections (CRBSIs) in home parenteral nutrition patients. AIMS To compare the effectiveness and safety of taurolidine and saline. METHODS This multicentre double-blinded trial randomly assigned home parenteral nutrition patients to use either 2% taurolidine or 0.9% saline for 1 year. Patients were stratified in a new catheter group and a pre-existing catheter group. Primary outcome was the rate of CRBSIs/1000 catheter days in the new catheter group and pre-existing catheter group, separately. RESULTS We randomised 105 patients, of which 102 were analysed as modified intention-to-treat population. In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009). In the pre-existing catheter group, rates of CRBSIs/1000 catheter days were 0.39 and 1.32 in the taurolidine and saline arm respectively (relative risk, 0.30; 95% CI, 0.03-1.82; P = 0.25). Excluding one outlier patient in the taurolidine arm, mean costs per patient were $1865 for taurolidine and $4454 for saline (P = 0.03). Drug-related adverse events were rare and generally mild. CONCLUSIONS In the new catheter group, taurolidine showed a clear decrease in CRBSI rate. In the pre-existing catheter group, no superiority of taurolidine could be demonstrated, most likely due to underpowering. Overall, taurolidine reduced the risk for CRBSIs by more than four times. Given its favourable safety and cost profile, taurolidine locking should be considered as an additional strategy to prevent CRBSIs. TRIAL REGISTRATION Clinicaltrials.gov, identifier: NCT01826526.",2018,"In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009).","['105 patients, of which 102 were analysed as modified intention-to-treat population', 'home parenteral nutrition patients', 'patients on home parenteral nutrition']","['saline locking', 'parenteral nutrition patients to use either 2% taurolidine or 0.9% saline', 'taurolidine and saline', 'taurolidine', 'taurolidine locking']","['mean costs per patient', 'rates of CRBSIs/1000 catheter days', 'CRBSI rate', 'effectiveness and safety', 'rate of CRBSIs/1000 catheter days', 'risk for CRBSIs']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0079543', 'cui_str': 'Parenteral Nutrition, Home'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0144567', 'cui_str': 'taurolidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.390806,"In the new catheter group, rates of CRBSIs/1000 catheter days were 0.29 and 1.49 in the taurolidine and saline arm respectively (relative risk, 0.20; 95% CI, 0.04-0.71; P = 0.009).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wouters', 'Affiliation': 'Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The\xa0Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Theilla', 'Affiliation': 'General Intensive Care Department, Rabin Medical Centre, Beilinson Hospital and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'General Intensive Care Department, Rabin Medical Centre, Beilinson Hospital and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tribler', 'Affiliation': 'Department of Medical Gastroenterology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pironi', 'Affiliation': 'Centre for Chronic Intestinal Failure, Department of Medical and Surgical Science, University of Bologna, Bologna, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vinter-Jensen', 'Affiliation': 'Department of Gastroenterology, Centre for Nutrition and Bowel Disease, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Gastroenterology, Centre for Nutrition and Bowel Disease, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rahman', 'Affiliation': 'Department of Gastroenterology, University College London Hospital, London, UK.'}, {'ForeName': 'G J A', 'Initials': 'GJA', 'LastName': 'Wanten', 'Affiliation': 'Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The\xa0Netherlands.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.14904'] 339,32097932,The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study.,"BACKGROUND The NORSTENT trial randomized 9,013 patients to percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS) with 5-year follow-up. No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularizations, which were reduced by DES. We report the occurrence of target lesion revascularization (TLR) in time and across demographic and clinical subgroups in patients with lesions in native coronary arteries (n = 8,782). RESULTS Clinically driven TLR was performed on 488 (5.6%) of the 8,782 patients during 5 years of follow-up. Male gender, older age, visible thrombus in the lesion, and larger stent diameter were associated with less TLR; multivessel disease and longer stents were associated with a higher risk of TLR. There was a substantial and highly significant reduction of the risk of any TLR after 5 years in the DES group (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.36-0.52], p < 0.001). The effect of DES on TLR was limited in time to the first 2 years in the study with no evidence of a later rebound effect. The reduction in TLR after DES insertion was consistent across subgroups defined by gender, age, diabetes status, renal function, and lesion and stent characteristics. The number needed to treat with DES (vs. BMS) to prevent 1 TLR ranged from 4 to 110 across clinically relevant subgroups. CONCLUSION DES have a time-limited effect on the rate of TLR, but with a substantial and highly significant reduction in the first 2 years after the procedure. This effect was found to be consistent across all important clinical subgroups.",2020,No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up.,"['patients with lesions in native coronary arteries (n = 8,782', '9,013 patients to', 'Native Coronary Arteries']","['DES', 'percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) or bare-metal stent (BMS', 'Drug-Eluting Stents', 'target lesion revascularization (TLR']","['risk of any TLR', 'death from any cause and nonfatal spontaneous myocardial infarction', 'rate of TLR', 'reduction in TLR', 'repeat revascularizations, which were reduced by DES']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",9013.0,0.208977,No difference was found in the composite primary outcome of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up.,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Mølstad', 'Affiliation': 'Department of Cardiology, LHL Clinics Gardermoen, Jessheim, Norway, PerMorten.Molstad@lhl.no.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Nordrehaug', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Steigen', 'Affiliation': 'University Hospital of North Norway and UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Lasse Melvaer', 'Initials': 'LM', 'LastName': 'Giil', 'Affiliation': 'Department of Internal Medicine, Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': ""Clinic of Cardiology, St. Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Kaare H', 'Initials': 'KH', 'LastName': 'Bønaa', 'Affiliation': ""Clinic of Cardiology, St. Olav's University Hospital, Trondheim, Norway.""}]",Cardiology,['10.1159/000506042'] 340,31027889,The effect of dry-weight reduction guided by lung ultrasound on ambulatory blood pressure in hemodialysis patients: a randomized controlled trial.,"Approximately 85% of hemodialysis patients are hypertensive, but less than 30% achieve adequate blood pressure (BP) control. Reduction of volume overload is fundamental for BP control, but clinical criteria to estimate dry-weight are inaccurate. In the present study we examined the effect of dry-weight reduction with a lung-ultrasound-guided strategy on ambulatory BP in 71 clinically euvolemic hemodialysis patients with hypertension. Patients were equally randomized into an active group, following a strategy for dry-weight reduction guided by pre-hemodialysis lung ultrasound, and a control group with standard-of-care treatment. All patients underwent 48-hour ambulatory BP monitoring (ABPM) at baseline and after eight weeks. Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively. The ultrasonographic-B line change during follow-up was significantly different (-5.3±12.5 in active versus +2.2±7.6 in control group), which corresponded to significant differences in dry weight changes between the groups. The magnitude of reductions in 48-hour systolic BP (-6.61±9.57 vs. -0.67±13.07) and diastolic BP (-3.85±6.34 vs. -0.55±8.28) was significantly greater in the active group. Similarly, intradialytic BP, 44-hour BP, and daytime or night-time systolic/diastolic BP during both days of the interdialytic interval were significantly reduced in the active group but remained unchanged in the control group. The percentage of patients experiencing one or more intradialytic hypotensive episodes was marginally lower in the active group (34.3% vs. 55.6%). Thus, a lung-ultrasound-guided strategy for dry-weight reduction can effectively and safely reduce ambulatory BP levels in hemodialysis patients. Clinical implementation of this simple technique can help increase BP control in this population.",2019,"Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively.","['71 clinically euvolemic hemodialysis patients with hypertension', 'hemodialysis patients']","['dry-weight reduction guided by lung ultrasound', 'dry-weight reduction with a lung-ultrasound-guided strategy', '48-hour ambulatory BP monitoring (ABPM', 'strategy for dry-weight reduction guided by pre-hemodialysis lung ultrasound, and a control group with standard-of-care treatment']","['ambulatory BP levels', 'dry weight changes', 'ambulatory blood pressure', 'adequate blood pressure (BP) control', 'percentage of patients experiencing one or more intradialytic hypotensive episodes', 'diastolic BP', 'intradialytic BP, 44-hour BP, and daytime or night-time systolic/diastolic BP during both days of the interdialytic interval', '48-hour systolic BP', 'ultrasonographic-B line change', 'BP control', 'dry weight reduction']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode (disorder)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0170317,"Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively.","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Pantelis A', 'Initials': 'PA', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece. Electronic address: psarafidis11@yahoo.gr.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'Department of Nephrology, University Clinical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Papadopoulos', 'Affiliation': '3rd Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Sachpekidis', 'Affiliation': 'Department of Cardiology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Maria Eleni', 'Initials': 'ME', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Efstratiadis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'London', 'Affiliation': 'Hospital and FCRIN INI-CRCTC, Manhes, France.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}]",Kidney international,['10.1016/j.kint.2019.02.018'] 341,32170964,Minocycline reduces experimental muscle hyperalgesia induced by repeated nerve growth factor injections in humans: A placebo-controlled double-blind drug-crossover study.,"BACKGROUND Hyperalgesia is a heightened pain response to a noxious stimulus and is a hallmark of many common neuropathic and chronic pain conditions. In a double-blind placebo-controlled drug-crossover trial, the effects of concomitant and delayed minocycline treatment on the initiation and resolution of muscle hyperalgesia were tested. METHODS An initial cohort (n = 10) received repeated injections (5 µg: days 0, 2 and 4) of nerve growth factor (NGF) in the flexor carpi ulnaris muscle of the forearm and pressure pain thresholds were collected at day 0 (control), day 7 (peak) and day 14 (recovery). A second cohort (n = 18) underwent an identical procedure, however, half received a placebo between days 0 and 7 before switching to minocycline from days 7 to 14 (P1/M2), while the remaining subjects received minocycline (day 0: 200mg then 100mg b.i.d. for 7 days) before switching to placebo (M1/P2). RESULTS The initial cohort exhibited a diffuse muscular pain hypersensitivity with a decrease in pressure pain thresholds at day 7 before a partial return to normalcy at day 14. The P1/M2 treatment group exhibited an identical peak in hypersensitivity at day 7, however, after switching to minocycline in week 2 showed a significant reduction in muscle hyperalgesia compared with the initial cohort at day 14. The M1/P2 treatment group had significantly less (~43%) hyperalgesia at day 7 compared with the other groups. CONCLUSIONS The study indicates that the administration of minocycline can reduce experimentally induced muscle pain regardless of the time of administration. SIGNIFICANCE In a double-blind placebo-controlled drug-crossover study, the common antibiotic minocycline was found to reduce the muscle hyperalgesia induced by intramuscular injection of nerve growth factor. The results of the study showed that both concomitant (pre-emptive) and delayed administration of minocycline can ameliorate the onset and facilitate the resolution of experimentally induced muscle hyperalgesia.",2020,"The M1/P2 treatment group had significantly less (~50%) hyperalgesia at day 7 compared to the other groups. ","['An initial cohort (n=10) received', 'humans']","['concomitant and delayed minocycline', 'minocycline', 'repeated injections (5 µg: days 0, 2 and 4) of nerve growth factor (NGF', 'placebo (M1/P2', 'placebo', 'placebo between days 0-7 before switching to minocycline', 'Minocycline']","['hyperalgesia', 'hypersensitivity', 'muscle hyperalgesia', 'initiation and resolution of muscle hyperalgesia', 'pressure pain thresholds']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",,0.276906,"The M1/P2 treatment group had significantly less (~50%) hyperalgesia at day 7 compared to the other groups. ","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Dunn', 'Affiliation': 'School of Medicine, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Saad S', 'Initials': 'SS', 'LastName': 'Nagi', 'Affiliation': 'School of Medicine, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mahns', 'Affiliation': 'School of Medicine, Western Sydney University, Penrith, NSW, Australia.'}]","European journal of pain (London, England)",['10.1002/ejp.1558'] 342,30817465,Neurohumoral and ambulatory haemodynamic adaptations following isometric exercise training in unmedicated hypertensive patients.,"OBJECTIVE Hypertension remains the leading modifiable risk factor for cardiovascular disease. Isometric exercise training (IET) has been shown to be a useful nonpharmacological intervention for reducing resting blood pressure (BP). This study aimed to measure alterations in office BP, ambulatory BP, cardiac autonomic modulation and inflammatory and vascular biomarkers following a programme of IET in unmedicated hypertensive patients. METHODS Twenty-four unmedicated stage 1 hypertensive patients (age 43.8 ± 7.3 years; height, 178.1 ± 7 cm; weight 89.7 ± 12.8 kg) were randomly assigned in a cross-over study design, to 4-weeks of home-based IET and control period, separated by a 3-week washout period. Office and ambulatory BP, cardiac autonomic modulation, and inflammatory and vascular biomarkers were recorded pre and post-IET and control periods. RESULTS Clinic and 24-h ambulatory BP significantly reduced following IET by 12.4/6.2 and 11.8/5.6 mmHg in SBP/DBP, respectively (P < 0.001 for both), compared with the control. The BP adaptations were associated with a significant (P = 0.018) reduction in the average real variability of 24-h ambulatory BP following IET, compared with control. Cardiac autonomic modulation improved by 11% (P < 0.001), baroreceptor reflex sensitivity improved by 47% (P < 0.001), and IL-6 and asymmetric dimethylarginine reduced by 10% (P = 0.022) and 19% (P = 0.023), respectively, which differed significantly to the control period. CONCLUSION This is the first evidence of durable BP reduction and wider cardiovascular disease risk benefits of IET in a relevant patient population. Our findings support the role of IET as a safe and viable therapeutic and preventive intervention in the treatment of hypertension.",2019,"Cardiac autonomic modulation improved by 11% (P < 0.001), baroreceptor reflex sensitivity improved by 47% (P < 0.001), and IL-6 and asymmetric dimethylarginine reduced by 10% (P = 0.022) and 19% (P = 0.023), respectively, which differed significantly to the control period. ","['unmedicated hypertensive patients', 'Twenty-four unmedicated stage 1 hypertensive patients (age 43.8\u200a±\u200a7.3 years; height, 178.1\u200a±\u200a7\u200acm; weight 89.7\u200a±\u200a12.8\u200akg']","['Isometric exercise training (IET', 'isometric exercise training', 'IET']","['average real variability of 24-h ambulatory BP', 'office BP, ambulatory BP, cardiac autonomic modulation and inflammatory and vascular biomarkers', 'Cardiac autonomic modulation', 'Clinic and 24-h ambulatory BP', 'IL-6 and asymmetric dimethylarginine', 'Office and ambulatory BP, cardiac autonomic modulation, and inflammatory and vascular biomarkers', 'BP adaptations', 'baroreceptor reflex sensitivity', 'resting blood pressure (BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517547', 'cui_str': '12.8'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.035637,"Cardiac autonomic modulation improved by 11% (P < 0.001), baroreceptor reflex sensitivity improved by 47% (P < 0.001), and IL-6 and asymmetric dimethylarginine reduced by 10% (P = 0.022) and 19% (P = 0.023), respectively, which differed significantly to the control period. ","[{'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Taylor', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Wiles', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent.'}, {'ForeName': 'Damian A', 'Initials': 'DA', 'LastName': 'Coleman', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leeson', 'Affiliation': 'Department of Cardiovascular Medicine, Oxford Clinical Cardiovascular Research Facility, University of Oxford, Oxford.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': ""Department of Cardiology, St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': ""O'Driscoll"", 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent.'}]",Journal of hypertension,['10.1097/HJH.0000000000001922'] 343,30817467,Serum uric acid and resistance to antihypertensive treatment: data from the European Lacidipine Study on Atherosclerosis.,"AIM Whether increased serum uric acid (SUA) favours resistance to antihypertensive drugs is not clear. METHODS The European Lacidipine Study on Atherosclerosis (ELSA) was a randomized, double-blind, multicenter trial comparing the effects of a 4-year treatment with either lacidipine or atenolol on progression of carotid atherosclerosis in patients with moderate hypertension. SUA was assessed at randomization and at the study end, office blood pressure (BP) was measured at each titration visit and every 6 months thereafter, ambulatory BP was measured at randomization and every year thereafter. RESULTS No difference was found in office and ambulatory BP reduction achieved after 1 and 4 years of treatment in baseline SUA tertiles. This was the case for both treatments. The percentage of patients with controlled office BP (<140/90 mmHg) after 1 year (36.5, 34.2 and 33.8%, P = 0.56) and 4 years (39.9, 39.4 and 38%, P = 0.82) was not different in SUA tertiles. Similar results were obtained basing the analysis on the control of ambulatory BP (<130/80 mmHg) or when data were analyzed taking into account SUA extreme values (≥7 and <3.5 mg/dl). The average and percentage changes of SUA (baseline-study end) were not different between patients who achieved or did not achieve office BP control (5.31 ± 1.26 vs. 5.4 ± 1.29 mg/dl, P = 0.22 e 0.13 ± 0.33 vs. 0.13 ± 0.68, P = 0.87, respectively). This was the case also for control of ambulatory BP. CONCLUSION In the ELSA study, SUA levels do not affect the responsiveness to antihypertensive treatment.",2019,No difference was found in office and ambulatory BP reduction achieved after 1 and 4 years of treatment in baseline SUA tertiles.,['patients with moderate hypertension'],['lacidipine or atenolol'],"['office and ambulatory BP reduction', 'control of ambulatory BP', 'office blood pressure (BP', 'SUA', 'ambulatory BP', 'progression of carotid atherosclerosis', 'Serum uric acid and resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0064568', 'cui_str': 'lacidipine'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0577631', 'cui_str': 'Carotid Atherosclerosis'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}]",,0.13195,No difference was found in office and ambulatory BP reduction achieved after 1 and 4 years of treatment in baseline SUA tertiles.,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bombelli', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Macchiarulo', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Facchetti', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Maggiolini', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Cuspidi', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Department of Medicine and Surgery.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine and Surgery.'}]",Journal of hypertension,['10.1097/HJH.0000000000001951'] 344,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3 antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2'] 345,32145372,Go/no-go for food: Attention bias and intention to eat unhealthy food.,"OBJECTIVE The current research evaluated whether Go/No-go training for highly palatable (HP) food affected attention bias for HP food (an automatic/implicit outcome) and intention to eat unhealthy food (a controlled/explicit outcome). METHOD A sample of Australian adults representative for age, gender and Body Mass Index (BMI) (N = 561, M age  = 46.31 years, SD = 16.75, 52.3% women, M BMI  = 27.11, SD = 6.34) completed self-report measures of dietary psychological constructs and food image modified Stroop tasks as measures of pre- and post-test attention bias for HP food. After random assignment of participants to two conditions, a Go/No-go intervention was used to train HP food targeted inhibitory control in the experimental group, or general inhibitory control in the control group. All research tasks were delivered online. RESULTS The experimental, HP food inhibitory control training group reported intention to eat less unhealthy food than the control group, F (1, 637) = 4.81, R 2  = 0.09, p = .029. Counter to expectations, the experimental group exhibited a heightened attention bias to HP food images after the training, F (1, 637) = 9.48, R 2  = 0.39, p = .002. CONCLUSION Go/No-go training for food may improve both top-down and bottom-up inhibitory control, using both automatic and controlled processes. Further, it may not be effective in lowering attention bias for HP food, but may be effective in lowering unhealthy food intake despite raising attention bias for HP food. Further research that tests these effects using varied reaction time tasks is needed to confirm these results and to explore possible alternative explanations.",2020,"The experimental, HP food inhibitory control training group reported intention to eat less unhealthy food than the control group, F (1, 637) = 4.81, R 2  = 0.09, p = .029.","['A sample of Australian adults representative for age, gender and Body Mass Index (BMI', 'N\u202f=\u202f561, M age \u202f=\u202f46.31 years, SD\u202f=\u202f16.75, 52.3% women, M BMI']",[],"['intention to eat less unhealthy food', 'self-report measures of dietary psychological constructs and food image']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.0482887,"The experimental, HP food inhibitory control training group reported intention to eat less unhealthy food than the control group, F (1, 637) = 4.81, R 2  = 0.09, p = .029.","[{'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Love', 'Affiliation': 'University of New England, Australia.'}, {'ForeName': 'Navjot', 'Initials': 'N', 'LastName': 'Bhullar', 'Affiliation': 'University of New England, Australia. Electronic address: navjot.bhullar@une.edu.au.'}, {'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Schutte', 'Affiliation': 'University of New England, Australia.'}]",Appetite,['10.1016/j.appet.2020.104646'] 346,31691413,High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial.,"AIMS To test the efficacy of a therapist-guided high-intensity internet intervention compared with an unguided low-intensity internet intervention among individuals with alcohol use disorder. DESIGN A three-group randomized controlled trial with follow-up assessments post-treatment (12 weeks) and 6 months post-randomization (primary end-point). SETTINGS General population sample in Sweden. PARTICIPANTS A total of 166 on-line self-referred adults (49% males) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview. INTERVENTIONS AND COMPARATORS Both the high- (n = 72) and low-intensity internet interventions (n = 71) consisted of modules based on relapse prevention. Controls were on a waiting-list (n = 23), and were only followed until the post-treatment follow-up. Participants were randomized at a 7 : 7 : 2 ratio. MEASUREMENTS Primary outcome was self-reported alcohol consumption in the preceding week measured as (1) number of standard drinks and (2) number of heavy drinking days at the 6-month follow-up. FINDINGS Alcohol use disorders were largely in the severe category (74.7%), with the majority of participants having had alcohol problems for more than 5 years. Attrition was 13 and 22% at the post-treatment and 6-month follow-up, respectively. At the 6-month follow-up, an intent-to-treat analysis showed no significant differences in alcohol consumption between the high- and low-intensity interventions [standard drinks d = -0.17, 95% confidence interval (CI) = -0.50 to 0.16; heavy drinking days: d = -0.07, 95% CI = -0.40 to 0.26]. Prevalence of negative effects was somewhat low (8-14%) in both intervention groups, as was deterioration (3-5%). CONCLUSIONS At 6-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.",2020,"At six-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.","['individuals with an alcohol use disorder', 'alcohol use disorders', 'individuals with alcohol use disorder', '166 online self-referred adults (51% females) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview', 'General population sample in Sweden']","['therapist-guided high-intensity internet intervention', 'unguided low-intensity internet intervention', 'High- versus low-intensity internet interventions', 'high-intensity internet intervention', 'low-intensity internet intervention']","['alcohol problems', 'alcohol consumption', 'self-reported alcohol consumption in the preceding week measured as 1) number of standard drinks and 2) number of heavy drinking days', 'Prevalence of negative effects']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",166.0,0.0614733,"At six-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Eék', 'Affiliation': 'Department of Psychology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kraepelien', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fahlke', 'Affiliation': 'Department of Psychology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Jakobson', 'Affiliation': 'Stockholm County Council, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beckman', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14871'] 347,31296043,Michigan Stroke Transitions Trial.,"BACKGROUND To test whether access to home-based social worker-led case management (SWCM) program or SWCM program combined with a website providing stroke-related information improves patient-reported outcomes in patients with stroke, relative to usual care. METHODS AND RESULTS The MISTT (Michigan Stroke Transitions Trial), an open (unblinded) 3-group parallel-design clinical trial, randomized 265 acute patients with stroke to 3 treatment groups: Usual Care (group-1), SWCM (group-2), and SWCM+MISTT website (group-3). Patients were discharged directly home or returned home within 4 weeks of discharge to a rehabilitation facility. The SWCM program provided in-home and phone-based case management services. The website provided patient-orientated information covering stroke education, prevention, recovery, and community resources. Both interventions were provided for up to 90 days. Outcomes data were collected by telephone at 7 and 90 days. Primary patient-reported outcomes included Patient-Reported Outcomes Measurement Information System Global-10 Quality-of-Life (Physical and Mental Health subscales) and the Patient Activation Measure. Treatment efficacy was determined by comparing the change in mean response (90 days minus 7 days) between the 3 treatment groups using a group-by-time interaction. Subjects were aged 66 years on average, 49% were female, 21% nonwhite, and 86% had ischemic stroke. There were statistically significant changes in Patient-Reported Outcomes Measurement Information System Physical Health ( P=0.003) and Patient Activation Measure ( P=0.042), but not Patient-Reported Outcomes Measurement Information System Mental Health ( P=0.56). The mean change in Patient-Reported Outcomes Measurement Information System Physical Health scores for group-3 (SWCM+MISTT Website) was significantly higher than both group-2 (SWCM; difference, +2.4; 95% CI, 0.46-4.34; P=0.02) and group-1 (usual care; difference, +3.4; 95% CI, 1.41-5.33; P<0.001). The mean change in Patient Activation Measure scores for group-3 was significantly higher than group-2 (+6.7; 95% CI, 1.26-12.08; P=0.02) and marginally higher than group-1 (+5.0; 95% CI, -0.47 to 10.52; P=0.07). CONCLUSIONS An intervention that combined SWCM with access to online stroke-related information produced greater gains in patient-reported physical health and activation compared with usual care or case management alone. There was no intervention effect on mental health. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT02653170.",2019,"There were statistically significant changes in Patient-Reported Outcomes Measurement Information System Physical Health ( P=0.003) and Patient Activation Measure ( P=0.042), but not Patient-Reported Outcomes Measurement Information System Mental Health ( P=0.56).","['265 acute patients with stroke to 3 treatment groups', 'Patients were discharged directly home or returned home within 4 weeks of discharge to a rehabilitation facility', 'Subjects were aged 66 years on average, 49% were female, 21% nonwhite, and 86% had ischemic stroke', 'patients with stroke, relative to usual care']","['Usual Care (group-1), SWCM (group-2), and SWCM+MISTT website (group-3']","['Treatment efficacy', 'mental health', 'mean response', 'Patient-Reported Outcomes Measurement Information System Physical Health', 'Patient-Reported Outcomes Measurement Information System Global-10 Quality-of-Life (Physical and Mental Health subscales) and the Patient Activation Measure', 'Patient Activation Measure', 'mean change in Patient Activation Measure scores', 'Outcomes Measurement Information System Physical Health scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0579192', 'cui_str': 'Returned home, life event (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C4075707', 'cui_str': 'PAM - Patient Activation Measure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4075848', 'cui_str': 'Patient Activation Measure score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",265.0,0.102514,"There were statistically significant changes in Patient-Reported Outcomes Measurement Information System Physical Health ( P=0.003) and Patient Activation Measure ( P=0.042), but not Patient-Reported Outcomes Measurement Information System Mental Health ( P=0.56).","[{'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Reeves', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine (M.J.R., M.C.F., M.N.), Michigan State University, East Lansing.'}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Fritz', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine (M.J.R., M.C.F., M.N.), Michigan State University, East Lansing.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Woodward', 'Affiliation': 'School of Social Work, College of Social Science (A.T.W., A.K.H., P.P.F.), Michigan State University, East Lansing.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Hughes', 'Affiliation': 'School of Social Work, College of Social Science (A.T.W., A.K.H., P.P.F.), Michigan State University, East Lansing.'}, {'ForeName': 'Constantinos K', 'Initials': 'CK', 'LastName': 'Coursaris', 'Affiliation': 'Department of Information Technologies, HEC, Montréal, Canada (C.K.C.).'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Swierenga', 'Affiliation': 'Usability/Accessibility Research and Consulting, University Outreach and Engagement (S.J.S.), Michigan State University, East Lansing.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine (M.J.R., M.C.F., M.N.), Michigan State University, East Lansing.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Freddolino', 'Affiliation': 'School of Social Work, College of Social Science (A.T.W., A.K.H., P.P.F.), Michigan State University, East Lansing.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005493'] 348,32291223,"Adding mobilisation with movement to exercise and advice hastens the improvement in range, pain and function after non-operative cast immobilisation for distal radius fracture: a multicentre, randomised trial.","QUESTION Does adding mobilisation with movement (MWM) to usual care (ie, exercises plus advice) improve outcomes after immobilisation for a distal radius fracture? DESIGN A prospective, multicentre, randomised, clinical trial with concealed allocation, blinding and intention-to-treat analysis. PARTICIPANTS Sixty-seven adults (76% female, mean age 60 years) treated with casting after distal radius fracture. INTERVENTION The control group received exercises and advice. The experimental group received the same exercises and advice, plus supination and wrist extension MWM. OUTCOME MEASURES The primary outcome was forearm supination at 4 weeks (immediately post-intervention). Secondary outcomes included wrist extension, flexion, pronation, grip strength, QuickDASH (Disabilities of Arm, Shoulder and Hand), Patient-Rated Wrist Evaluation (PRWE) and global rating of change. Follow-up time points were 4 and 12 weeks, with patient-rated measures at 26 and 52 weeks. RESULTS Compared with the control group, supination was greater in the experimental group by 12 deg (95% CI 5 to 20) at 4 weeks and 8 deg (95% CI 1 to 15) at 12 weeks. Various secondary outcomes were better in the experimental group at 4 weeks: extension (14 deg, 95% CI 7 to 20), flexion (9 deg, 95% CI 4 to 15), QuickDASH (-11, 95% CI -18 to -3) and PRWE (-13, 95% CI -23 to -4). Benefits were still evident at 12 weeks for supination, extension, flexion and QuickDASH. The experimental group were more likely to rate their global change as 'improved' (risk difference 22%, 95% CI 5 to 39). There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects. CONCLUSION Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture. REGISTRATION ACTRN12615001330538.",2020,"There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects. CONCLUSION Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture. ","['Sixty-seven adults (76% female, mean age 60 years) treated with casting after distal radius fracture', 'distal radius fracture']","['exercises and advice', 'same exercises and advice, plus supination and wrist extension MWM', 'mobilisation with movement (MWM) to usual care (ie, exercises plus advice']","[""rate their global change as 'improved"", 'flexion', 'motion impairments', 'forearm supination', 'wrist extension, flexion, pronation, grip strength, QuickDASH (Disabilities of Arm, Shoulder and Hand), Patient-Rated Wrist Evaluation (PRWE) and global rating of change', 'QuickDASH', 'range, pain and function']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",67.0,0.284206,"There were no clear benefits in any of the participant-rated measures at 26 and 52 weeks, and no adverse effects. CONCLUSION Adding MWM to exercise and advice gives a faster and greater improvement in motion impairments for non-operative management of distal radius fracture. ","[{'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Reid', 'Affiliation': 'School of Allied Health, Australian Catholic University, Sydney, Australia. Electronic address: Sue.Reid@acu.edu.au.'}, {'ForeName': 'Josef M', 'Initials': 'JM', 'LastName': 'Andersen', 'Affiliation': 'MULLIGAN DK, Hørsholm, Denmark.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.03.010'] 349,32184121,Cetuximab and Radiation Therapy Versus Cisplatin and Radiation Therapy for Locally Advanced Head and Neck Cancer: Long-Term Survival and Toxicity Outcomes of a Randomized Phase 2 Trial.,"PURPOSE This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN). METHODS AND MATERIALS Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m 2 ) or CTX (250 mg/m 2 plus a loading dose of 400 mg/m 2 ). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed. RESULTS No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm. CONCLUSIONS Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.",2020,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","['ADVANCED HEAD AND NECK CANCER', 'Between January 2011 and August 2014, 70 patients', 'locally advanced head and neck cancer (LASCCHN']","['RT + CTX', 'radiotherapy (RT) plus cisplatin (CDDP) or cetuximab (CTX', 'CTX', 'RT plus weekly CDDP']","['5-year LC rates', 'late effects (xerostomia, fibrosis, mucosal atrophy, weight loss', '5-year CSS rates', 'HPV- OPC', '5-years OS rates', 'local control (LC), overall survival (OS), cancer-specific survival (CSS) and metastasis free survival (MFS', '5-year MFS rates', 'late toxicities', 'MFS rates', 'HPV+ oropharyngeal carcinoma (OPC) better survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2242595', 'cui_str': 'Mucosal atrophy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",70.0,0.184636,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maddalo', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Borghetti', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tomasini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy. Electronic address: tomad88@libero.it.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Corvò', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bonomo', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Petrucci', 'Affiliation': 'Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Paiar', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Lastrucci', 'Affiliation': 'S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo, Italy.'}, {'ForeName': 'Marco Lorenzo', 'Initials': 'ML', 'LastName': 'Bonù', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Greco', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Pegurri', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Triggiani', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Belgioia', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Isacco', 'Initials': 'I', 'LastName': 'Desideri', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grisanti', 'Affiliation': 'Medical Oncology ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Buglione', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Stefano Maria', 'Initials': 'SM', 'LastName': 'Magrini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.02.637'] 350,31656057,Diffusion of effects of the ASSIST school-based smoking prevention intervention to non-participating family members: a secondary analysis of a randomized controlled trial.,"AIMS To investigate whether effects of the ASSIST (A Stop Smoking In Schools Trial) school-based smoking prevention intervention diffused from students to the people they lived with. DESIGN Secondary analysis of a cluster-randomized control trial (cRCT). SETTING England and Wales. PARTICIPANTS A total of 10 730 students aged 12-13 years in 59 schools assigned using stratified block randomization to the control (29 schools, 5372 students) or intervention (30 schools, 5358 students) condition. INTERVENTION AND COMPARATOR The ASSIST intervention involves 2 days of off-site training of influential students to encourage their peers not to smoke during a 10-week period. The control group continued with their usual education. MEASUREMENTS The outcomes were the proportion of students who self-reported living with a smoker and the smoking status of each resident family member/caregiver. Follow-up assessments were immediately after the intervention and at 1 and 2 years post-intervention. FINDINGS The odds ratio (OR) for living with a smoker in the intervention compared with the control groups was 0.86 [95% confidence interval (CI) = 0.72, 1.03] immediately after the intervention, OR = 0.84 (95% CI = 0.72, 0.97) at a 1-year follow-up and OR = 0.86 (95% CI = 0.75, 0.99) at 2-year follow-up. In a three-tier multi-level model with data from all three follow-ups, student-reported smoking by fathers (OR = 0.90, 95% CI = 0.80, 1.00), brothers (OR = 0.78, 95% CI = 0.67, 0.92) and sisters (OR = 0.80, 95% CI = 0.69, 0.92) was lower in the intervention compared with control group. Subgroup analyses by baseline smoking status suggested that these effects were more consistent with prevention of uptake than prompting cessation. CONCLUSIONS A Stop Smoking In Schools Trial (ASSIST) school-based smoking prevention intervention may have reduced the prevalence of smoking in people who lived with ASSIST-trained students. This indirect transmission is consistent with the predictions of diffusion of innovations theory which underpins the design of ASSIST.",2020,"The odds ratio for living with a smoker in the intervention compared with control group was 0.86 (95% confidence interval 0.72, 1.03) immediately after the intervention, 0.84 (0.72, 0.97) at a 1-year follow-up, and 0.86 (0.75, 0.99) at a 2-year follow-up.","['people who lived with ASSIST-trained students', '10,730 students aged 12-13 years in 59 schools assigned using stratified block randomisation to the control (29 schools, 5,372 students) or intervention (30 schools, 5,358 students) condition', 'non-participating family members', 'England and Wales', 'students to the people they lived with']","['ASSIST (A Stop Smoking', 'school-based smoking prevention intervention', 'ASSIST school-based smoking prevention intervention']","['odds ratio for living with a smoker', 'proportion of students who self-reported living with a smoker and the smoking status of each resident family member/caregiver']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1519385', 'cui_str': 'Smoking Prevention'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.0670404,"The odds ratio for living with a smoker in the intervention compared with control group was 0.86 (95% confidence interval 0.72, 1.03) immediately after the intervention, 0.84 (0.72, 0.97) at a 1-year follow-up, and 0.86 (0.75, 0.99) at a 2-year follow-up.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Holliday', 'Affiliation': 'Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Daniel', 'Affiliation': 'School of Medicine, Cardiff University, Neuadd Meirionnydd, Cardiff, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14862'] 351,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z'] 352,32284277,Virtual reality simulator improves the acquisition of basic arthroscopy skills in first-year orthopedic surgery residents.,"INTRODUCTION Arthroscopy training using a virtual reality (VR) simulator is said to improve the training of orthopedic surgery residents, although it has never been evaluated in a large representative population of first-year residents. HYPOTHESIS We hypothesized that first-year residents who train on a VR simulator would improve their basic arthroscopy skills more than residents who use other training methods. The primary aim was to compare various arthroscopy-learning techniques after 6 months of training. POPULATION AND METHODS The study population consisted of 107 first-year residents who were tested twice on a VR arthroscopy simulator (December 2017 and June 2018). The residents were divided into three groups: no specific arthroscopy training (A), non-specific and one-off arthroscopy training (B), 6 months of VR arthroscopy simulator training (C). During the testing, they had to perform the Periscoping exercise (orientation of angled scope) and the Catch the Stars Glenohumeral exercise (extraction of loose bodies). The parameters analyzed were time (s), camera alignment relative to horizontal (%), camera path length (cm) and grasper path length (cm). RESULTS After 6 months, there was a significant difference between groups during the Periscoping exercise in the time (A: 137.8 s; B: 126.7 s; C: 92.2 s) (p<0.0001), camera alignment (A: 93%; B: 98%; C: 97%) (p=0.0028), camera path length (A: 116.9cm; B: 112.5cm; C: 67.3cm) (p<0.0001) and during the Catch the Stars Glenohumeral exercise in the time (A: 112.2 s; B: 103 s; C: 61.4 s) (p<0.0001), camera path length (A: 46.3cm; B: 40.9cm; C: 32.9cm) (p<0.0153) and grasper path length (A: 146.4cm; B: 142.2cm; C: 95.8cm) (p<0.0001). DISCUSSION The residents who participated in the VR arthroscopy simulator training program for 6 months had better results when performing practical exercises and standard arthroscopy tasks than those who did not receive any training or only received only one-off training. Their final performance indicated technical mastery that the other residents had not achieved. LEVEL OF EVIDENCE II, Prospective, comparative, non-randomized study.",2020,The residents who participated in the VR arthroscopy simulator training program for 6 months had better results when performing practical exercises and standard arthroscopy tasks than those who did not receive any training or only received only one-off training.,"['first-year orthopedic surgery residents', '107 first-year residents who were tested twice on a VR arthroscopy simulator (December 2017 and June 2018']","['VR arthroscopy simulator training program', 'Arthroscopy training using a virtual reality (VR) simulator', 'VR simulator', 'practical exercises and standard arthroscopy tasks than those who did not receive any training or only received only one-off training', 'no specific arthroscopy training (A), non-specific and one-off arthroscopy training (B), 6 months of VR arthroscopy simulator training (C', 'Virtual reality simulator']","['technical mastery', 'acquisition of basic arthroscopy skills', 'grasper path length ', 'basic arthroscopy skills', 'camera path length', 'time (s), camera alignment relative to horizontal (%), camera path length (cm) and grasper path length (cm']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",,0.0243218,The residents who participated in the VR arthroscopy simulator training program for 6 months had better results when performing practical exercises and standard arthroscopy tasks than those who did not receive any training or only received only one-off training.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Walbron', 'Affiliation': ""Service d'orthopédie, centre chirurgical Emile-Gallé, CHRU de Nancy, 49, rue Hermite, 54000 Nancy, France. Electronic address: paul.walbron@orange.frw.""}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Common', 'Affiliation': ""Service d'orthopédie, CHRU de Rennes, 35000 Rennes, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Thomazeau', 'Affiliation': ""Service d'orthopédie, CHRU de Rennes, 35000 Rennes, France.""}, {'ForeName': 'Kossar', 'Initials': 'K', 'LastName': 'Hosseini', 'Affiliation': ""Plateforme d'aide à la recherche clinique, CHRU de Nancy, 54511 Vandœuvre-lès-Nancy, France.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Peduzzi', 'Affiliation': ""Service d'orthopédie, centre chirurgical Emile-Gallé, CHRU de Nancy, 49, rue Hermite, 54000 Nancy, France.""}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Bulaid', 'Affiliation': ""Service d'orthopédie, CHRU d'Amiens, 80000 Amiens, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Sirveaux', 'Affiliation': ""Service d'orthopédie, centre chirurgical Emile-Gallé, CHRU de Nancy, 49, rue Hermite, 54000 Nancy, France.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.03.009'] 353,31295174,Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.,"BACKGROUND In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine. METHODS We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. RESULTS Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors. CONCLUSIONS ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.",2019,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"['3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD']","['tenofovir/emtricitabine', 'zidovudine/lamivudine']","['adverse pregnancy outcomes', 'stillbirth and early loss/spontaneous abortion', 'severe outcomes of very LBW']","[{'cui': 'C4708907', 'cui_str': '3333 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3333.0,0.195455,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Sebikari', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qin', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal and Paediatric Infectious Diseases Branch, Bethesda, MD.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of North Carolina (UNC) Project Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Neetal', 'Initials': 'N', 'LastName': 'Nevrekar', 'Affiliation': 'Clinical Research Department, Byramiee Jeeieebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Tsungai', 'Initials': 'T', 'LastName': 'Chipato', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Clinical Medicine, Centre for AIDS Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002072'] 354,30814669,Influence of training protocols on text input speed on a computer in individuals with cervical spinal cord injury: a randomised controlled trial.,"STUDY DESIGN Randomised controlled trial. OBJECTIVES To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective. SETTING Rehabilitation department, Garches, France. METHODS Participants with neurological levels between C6 and C8 were allocated to one of three different groups. The REHAB group underwent training with an occupational therapist. The SELF group carried out a standardised home self-training with a written training guide. The CONTROL group had no training. Participants were assessed at day 15 (D15) and day 30 (D30). The primary outcome was a copying task with and without WPS (WITH and WITHOUT). RESULTS Forty-two participants (mean age ± SD of 39.8 ± 12) were included and 38 completed the study. At D30, the mean (95% confidence interval) difference in TIS between the CONTROL and SELF groups was 3.8 [-1.7 to 9.4] characters per minute (cpm) (p = 0.23), between the REHAB and SELF groups was 12.9 [7.4 to 18.4] cpm (p < 0.001), and between the REHAB and CONTROL groups was 9.1 [3.5 to 14.6] cpm (p < 0.001). CONCLUSIONS The results of this study showed that occupational therapist-supervised training improved TIS but word prediction software did not increase TIS. These results suggest that supervised training should be provided to all individuals who are prescribed with devices and systems to facilitate computer access in order to increase their TIS.",2019,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective. ","['Participants with neurological levels between C6 and C8', 'individuals with cervical spinal cord injury', 'people with tetraplegia', 'Forty-two participants (mean age\u2009±\u2009SD of 39.8\u2009±\u200912) were included and 38 completed the study', 'Rehabilitation department, Garches, France']","['training protocols', 'word prediction software (WPS) training protocols', 'standardised home self-training with a written training guide', 'training with an occupational therapist']","['TIS', 'text input speed (TIS', 'copying task with and without WPS (WITH and WITHOUT']","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}]",,0.0702357,"To evaluate the impact of two different word prediction software (WPS) training protocols on text input speed (TIS) in people with tetraplegia and to determine which was the most effective. ","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France. samuel.pouplin@aphp.fr.'}, {'ForeName': 'Djamel', 'Initials': 'D', 'LastName': 'Bensmail', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vaugier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Axelle', 'Initials': 'A', 'LastName': 'Gelineau', 'Affiliation': 'New Technologies Plate-Form, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pottier', 'Affiliation': 'Clinical Innovations Centre 1429, AP-HP, Raymond Poincaré Teaching Hospital, Garches, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular Diseases, University of Versailles, St-Quentin-en-Yvelines, France.'}]",Spinal cord,['10.1038/s41393-019-0265-5'] 355,32293965,Re: Pelvic Floor Muscle Training in Radical Prostatectomy: A Randomized Controlled Trial of the Impacts on Pelvic Floor Muscle Function and Urinary Incontinence.,,2020,,['Radical Prostatectomy'],['Re: Pelvic Floor Muscle Training'],['Pelvic Floor Muscle Function and Urinary Incontinence'],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]",,0.0315816,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001059.03'] 356,32289804,A Single Motivational Lecture Can Promote Modest Weight Loss: A Randomized Controlled Trial.,"BACKGROUND Obesity is a public health problem worldwide. To widely disseminate weight-loss interventions across the target population, a cost-effective approach is needed. OBJECTIVE We aimed to test whether a single motivational lecture could promote weight loss. METHODS Our study was a 3-month randomized controlled trial, and we recruited participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan, and randomly assigned them to a control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h. No other lectures or textbooks were provided. The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome. The primary outcome was body weight change at 3 months. RESULTS We enrolled 145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2. The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively. The between-group difference was 1.83 kg (95% CI 1.15-2.51). CONCLUSIONS The significant difference suggested that a single motivational lecture is an effective option to promote modest weight loss in the short term.",2020,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","['participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan', '145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2', 'The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome']","['Motivational Lecture', 'control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h', 'single motivational lecture']","['body weight change at 3 months', 'Modest Weight Loss', 'weight loss', '3-month body weight change']","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",145.0,0.202298,"The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively.","[{'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan, nakata.yoshio.gn@u.tsukuba.ac.jp.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Faculty of Human Sciences, Shimane University, Matsue, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}]",Obesity facts,['10.1159/000506813'] 357,32291291,Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services.,"OBJECTIVES Common mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms. METHODS Randomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee's manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health. RESULTS A statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. CONCLUSION PSI was effective in reducing sickness absence which was the primary outcome in this study.",2020,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. ","['100 employees with stress symptoms or CMDs', 'Randomisation was conducted at the OHS consultant level and each consultant was allocated into either', 'employees with common mental disorders or stress-related symptoms at work', 'employees with CMDs or stress-related symptoms', 'Common mental disorders (CMDs']","['CAU', 'giving a brief problem-solving intervention (PSI) or care as usual (CAU']","['earlier partial RTW and the mental health', 'sickness absence', 'self-registered sickness absence, return to work (RTW) and mental health', 'registered sickness absence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",100.0,0.155075,"Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences. ","[{'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Keus van de Poll', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden marijke.keus.van.de.poll@ki.se.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Nybergh', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lornudd', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics (LIME), Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bodin', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Lohela-Karlsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Torgén', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Intervention and Implementation Research in Worker Health, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106353'] 358,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5'] 359,31386610,Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905).,"PURPOSE Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor inhibitor, demonstrated therapeutic potential in a prior phase I trial. We evaluated a phase II trial for efficacy. PATIENTS AND METHODS SWOG S0905 (ClinicalTrials.gov identifier: NCT01064648) randomly assigned cediranib or placebo with platinum-pemetrexed for six cycles followed by maintenance cediranib or placebo in unresectable chemotherapy-naïve patients with MPM of any histologic subtype. Primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS). Secondary end points included overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity. The trial was designed to detect a difference in RECIST v1.1 PFS at the one-sided 0.1 level using a stratified log-rank test. RESULTS Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid). The cediranib arm had more grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss. Cediranib improved PFS by RECIST v1.1 (hazard ratio, 0.71; 80% CI, 0.54 to 0.95; P = .062; 7.2 months v 5.6 months) and increased modified RECIST v1.1 response (50% v 20%; P = .006). By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months). No significant difference in overall survival was observed. CONCLUSION The addition of cediranib to platinum-pemetrexed improved PFS by RECIST v1.1 and response rate by modified RECIST in patients with unresectable MPM. Whereas adding antiangiogenics to chemotherapy has been a successful strategy for some patients, the cediranib toxicity profile and small incremental survival benefit precludes additional development in MPM.",2019,"By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months).","['Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid', 'patients with unresectable MPM', 'unresectable chemotherapy-naïve patients with MPM of any histologic subtype', 'unresectable malignant pleural mesothelioma (MPM', 'Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905']","['cediranib or placebo', 'Cediranib', 'cediranib or placebo with platinum-pemetrexed', 'Cisplatin and Pemetrexed', 'chemotherapy', 'Cediranib (AstraZeneca, Cheshire, United Kingdom']","['grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss', 'modified RECIST v1.1 response', 'PFS', 'overall survival', 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS', 'overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}]","[{'cui': 'C1698364', 'cui_str': '4-((4-Fluoro-2-methyl-1H-indol-5-yl)oxy)-6-methoxy-7-(3-(pyrrolidin-1-yl)propoxy)quinazoline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0454844', 'cui_str': 'Cheshire (geographic location)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",92.0,0.171406,"By modified RECIST v1.1, cediranib numerically increased PFS (hazard ratio, 0.77; 80% CI, 0.59 to 1.02; P = .12; median, 6.9 months v 5.6 months).","[{'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'Ignacio I', 'Initials': 'II', 'LastName': 'Wistuba', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology Comprehensive Cancer Centers of Nevada, Las Vegas, NV.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'Fossella', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Velasco', 'Affiliation': 'Cancer Care Specialists of Illinois, Decatur, IL.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Box-Noriega', 'Affiliation': 'Kaiser Permanente, Fresno, CA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hueftle', 'Affiliation': 'Montana Cancer Consortium, Billings, MT.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistical Center, Seattle, WA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00269'] 360,32286686,A randomized clinical trial of sildenafil plus clomiphene citrate to improve the success rate of ovulation induction in patients with unexplained infertility.,"OBJECTIVES To investigate the role of sildenafil citrate in improving ovulation induction success rate in women with unexplained infertility. METHODS A randomized clinical trial from January to December 2018 of 80 women with unexplained infertility randomized into two groups. Both groups received 100 mg clomiphene citrate once daily from days 3-7 of the menstrual cycle. The study group also received 25 mg oral sildenafil citrate twice daily from days 8-12 of the same cycle. Transvaginal ultrasound assessed ovulation, endometrial thickness, and number of follicles. Pregnancy was assessed 2 weeks after ovulation. Primary outcome measures were endometrial thickness, number of mature follicles, and pregnancy rates. RESULTS Pregnancy rates (26 (65%) and 16 (40%), P=0.043) and endometrial thickness (10.4 ± 1.4 and 9.2 ± 1.9, P=0.007) were significantly higher in the study group. More women in the study group reported adverse effects compared with the control group (17 [42.5%] vs 9 [22.5%]; P=0.034), with headache the most common adverse effect in the study group, reported by 8 (20.0%) patients. CONCLUSION Adding sildenafil citrate improved ovulation success rate and increased pregnancy rate. PAN AFRICAN CLINICAL TRIAL REGISTRY PACTR201907658492123.",2020,"RESULTS Pregnancy rates (26 (65%) and 16 (40%), P=0.043) and endometrial thickness (10.4±1.4 and 9.2±1.9, P=0.007) were significantly higher in the study group.","['women with unexplained infertility', 'January to December 2018 of 80 women with unexplained infertility randomized into two groups', 'patients with unexplained infertility']","['clomiphene citrate', 'sildenafil citrate', 'sildenafil plus clomiphene citrate', '25\xa0mg oral sildenafil citrate']","['success rate of ovulation induction', 'adverse effects', 'ovulation success rate and increased pregnancy rate', 'Transvaginal ultrasound assessed ovulation, endometrial thickness, and number of follicles', 'endometrial thickness, number of mature follicles, and pregnancy rates', 'endometrial thickness', 'Pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0600225', 'cui_str': 'Vesicular ovarian follicle structure'}]",80.0,0.478847,"RESULTS Pregnancy rates (26 (65%) and 16 (40%), P=0.043) and endometrial thickness (10.4±1.4 and 9.2±1.9, P=0.007) were significantly higher in the study group.","[{'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Aboelroose', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Zakia M', 'Initials': 'ZM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Elham H', 'Initials': 'EH', 'LastName': 'Madny', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elmazzahy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Omima T', 'Initials': 'OT', 'LastName': 'Taha', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13159'] 361,32286687,Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer.,"BACKGROUND The phase 3 KATHERINE trial demonstrated significantly improved invasive disease-free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy. METHODS Patients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30 days after study drug completion, and at 6- and 12-month follow-up visits. RESULTS Of patients who were randomly assigned to T-DM1 (n = 743) and trastuzumab (n = 743), 612 (82%) and 640 (86%), respectively, had valid baseline and ≥1 postbaseline assessments. No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%). CONCLUSION These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment.",2020,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"['Patients who received', 'patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer', 'patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy', 'with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery']","['adjuvant trastuzumab emtansine versus trastuzumab', 'adjuvant T-DM1', 'adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab', 'taxane- and trastuzumab-containing neoadjuvant therapy', 'trastuzumab']","['meaningful deterioration', 'appetite loss', 'mean QLQ-C30 and QLQ-BR23 scores', 'invasive disease-free survival', 'systemic therapy side effects', 'Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23', 'fatigue', 'constipation', 'quality of life', 'nausea/vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",743.0,0.0808795,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"[{'ForeName': 'PierFranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'DiSCOG, University of Padova and Division of Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation and Orlando Health University of Florida Health Cancer Center, Orlando, Florida.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Mano', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'AGO-B and HELIOS Klinikum Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stamatovic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': 'Institut Bergonié Unicancer and Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Castro-Salguero', 'Affiliation': 'Grupo Medico Angeles, Guatemala City, Guatemala.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Fischer', 'Affiliation': 'GBG and Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wahl', 'Affiliation': 'Swedish Cancer Institute, Issaquah, Washington.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulet', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation and Houston Methodist Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32873'] 362,31772157,Ketamine can reduce harmful drinking by pharmacologically rewriting drinking memories.,"Maladaptive reward memories (MRMs) are involved in the development and maintenance of acquired overconsumption disorders, such as harmful alcohol and drug use. The process of memory reconsolidation - where stored memories become briefly labile upon retrieval - may offer a means to disrupt MRMs and prevent relapse. However, reliable means for pharmacologically weakening MRMs in humans remain elusive. Here we demonstrate that the N-methyl D-aspartate (NMDA) antagonist ketamine is able to disrupt MRMs in hazardous drinkers when administered immediately after their retrieval. MRM retrieval + ketamine (RET + KET) effectively reduced the reinforcing effects of alcohol and long-term drinking levels, compared to ketamine or retrieval alone. Blood concentrations of ketamine and its metabolites during the critical 'reconsolidation window' predicted beneficial changes only following MRM reactivation. Pharmacological reconsolidation interference may provide a means to rapidly rewrite maladaptive memory and should be further pursued in alcohol and drug use disorders.",2019,"MRM retrieval + ketamine (RET + KET) effectively reduced the reinforcing effects of alcohol and long-term drinking levels, compared to ketamine or retrieval alone.",[],"['ketamine', 'N-methyl D-aspartate (NMDA) antagonist ketamine', 'Ketamine', 'MRM retrieval\u2009+\u2009ketamine (RET\u2009+\u2009KET']","['Blood concentrations', 'Maladaptive reward memories (MRMs']",[],"[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0145038,"MRM retrieval + ketamine (RET + KET) effectively reduced the reinforcing effects of alcohol and long-term drinking levels, compared to ketamine or retrieval alone.","[{'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK. ravi.das@ucl.ac.uk.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Gale', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Hennessy', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Iskandar', 'Affiliation': 'University College Hospital and University College Hospital at Westmoreland Street, London, UK.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Mordecai', 'Affiliation': 'Pain Management Centre, University College Hospital, London, UK.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Brandner', 'Affiliation': 'Pain Management Centre, University College Hospital, London, UK.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Experimental Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Sunjeev K', 'Initials': 'SK', 'LastName': 'Kamboj', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}]",Nature communications,['10.1038/s41467-019-13162-w'] 363,31908066,"Clinical effects beyond cocaine use of sustained-release dexamphetamine for the treatment of cocaine dependent patients with comorbid opioid dependence: secondary analysis of a double-blind, placebo-controlled randomized trial.","BACKGROUND AND AIMS Sustained-release (SR) formulations of dexamphetamine and mixed amphetamine salts have shown positive effects in the treatment of patients with a cocaine use disorder. We previously demonstrated the efficacy of SR-dexamphetamine for patients with cocaine dependence in terms of cocaine use reductions. In this secondary analysis, we assessed whether SR-dexamphetamine treatment also improves the health status of these patients. DESIGN Multi-centre randomized, double-blind placebo-controlled trial. SETTING Four supervised heroin-assisted treatment (HAT) out-patient clinics in the Netherlands. In HAT, methadone treatment-refractory opioid-dependent patients can self-administer individually titrated doses of pharmaceutical grade diacetylmorphine, coprescribed with oral methadone. PARTICIPANTS Seventy-three cocaine-dependent patients (90% males; average age = 48.7 years), participating in HAT for their treatment-refractory comorbid opioid dependence. INTERVENTIONS Twelve weeks pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine (2 × 30 mg/day) or two identical placebo tablets. MEASUREMENTS Assessment every 4 weeks: cocaine use (time-line follow-back), physical health (Maudsley Addiction Profile-Health Symptoms Scale), mental health (Brief Symptom Inventory) and illegal activities (Addiction Severity Index). Primary outcome was 'overall health', a dichotomous, multi-domain response index based on physical health, mental health and social functioning. FINDINGS Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment. While the number of cocaine abstinent days was not associated with overall health in the total study sample, it was positively associated with overall health among patients in poor overall health at the start of SR-dexamphetamine treatment (n = 50), i.e. patients with the potential to improve on this multi-domain response index (odds ratio = 1.076; 95% confidence interval = 1.025-1.130). CONCLUSIONS SR-dexamphetamine reduces cocaine use and may improve clinically relevant health-related outcomes in patients with cocaine dependence who are participating in heroin-assisted treatment for their comorbid heroin dependence.",2020,"Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment.","['Four supervised heroin-assisted treatment (HAT) out-patient clinics in the Netherlands', 'Seventy-three cocaine-dependent patients (90% males; average age\xa0=\xa048.7\xa0years), participating in HAT for their treatment-refractory comorbid opioid dependence', 'cocaine dependent patients with comorbid opioid dependence', 'patients with cocaine dependence who are participating in heroin-assisted treatment for their comorbid heroin dependence', 'patients with cocaine dependence in terms of cocaine use reductions', 'patients with a cocaine use disorder']","['placebo, SR-dexamphetamine', 'dexamphetamine and mixed amphetamine salts', 'pharmacotherapy with once-daily, supervised intake of two tablets of SR-dexamphetamine', 'cocaine', 'SR-dexamphetamine', 'placebo']","['cocaine use (time-line follow-back), physical health (Maudsley Addiction Profile-Health Symptoms Scale), mental health (Brief Symptom Inventory) and illegal activities (Addiction Severity Index', 'multi-domain response index', 'health status', 'overall health', ""overall health', a dichotomous, multi-domain response index based on physical health, mental health and social functioning"", 'proportion of overall health treatment responders', 'number of cocaine abstinent days']","[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444765', 'cui_str': 'Hat (physical object)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0524662', 'cui_str': 'Opiate Dependence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0019337', 'cui_str': 'Heroin Addiction'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0451543', 'cui_str': 'Time line follow back (assessment scale)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0585663', 'cui_str': 'Maudsley addiction profile (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.395234,"Compared with placebo, SR-dexamphetamine resulted in larger increases in the number of cocaine abstinent days (P = 0.004) and the proportion of overall health treatment responders (P = 0.045) from the 4 weeks preceding baseline to the final 4 weeks of treatment.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Blanken', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Nuijten', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van den Brink', 'Affiliation': 'Department of Psychiatry, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Vincent M', 'Initials': 'VM', 'LastName': 'Hendriks', 'Affiliation': 'Parnassia Addiction Research Centre (PARC), Brijder Verslavingszorg, The Hague, the Netherlands.'}]","Addiction (Abingdon, England)",['10.1111/add.14874'] 364,32275852,Storytelling Through Music: A Multidimensional Expressive Arts Intervention to Improve Emotional Well-Being of Oncology Nurses.,"PURPOSE Rates of burnout among health care professionals are rising. Oncology nurses are at the forefront of cancer care, and maintenance of their well-being is crucial to delivering high-quality care to people with cancer. The purpose of this pilot study was to implement a novel intervention, Storytelling Through Music, and examine the effects on depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction in oncology nurses. METHODS This two-group (intervention and control), quasi-experimental study of a 6-week intervention combined storytelling, reflective writing, songwriting, and stress management skills. RESULTS Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years. Both groups improved significantly over time on all measures. Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46; P < .001) and insomnia ( F [3, 120] = 5.77; P < .001) and greater self-compassion ( F [3, 105] = 2.88; P < .05) and self-awareness ( F [3, 120] = 2.42; P < .10). CONCLUSION There are few opportunities for health care professionals to reflect on the impact of caregiving. The Storytelling Through Music intervention provided a structured space for reflection by participants, individually and among their peers, which decreased loneliness and increased self-compassion. Both factors relate to the burnout that affects the oncology health care workforce.",2020,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46; P < .001) and insomnia ( F [3, 120] = 5.77; P < .001) and greater self-compassion ( F [3, 105] = 2.88; P < .05) and self-awareness ( F [3, 120] = 2.42; P < .10). ","['Participants (N = 43) were predominately white (98%), with 27% reporting Hispanic ethnicity, and female (95%); their average oncology experience was 8.5 years']","['intervention combined storytelling, reflective writing, songwriting, and stress management skills', 'Storytelling Through Music', 'Multidimensional Expressive Arts Intervention']","['insomnia', 'loneliness', 'self-awareness', 'depression, insomnia, loneliness, self-awareness, self-compassion, burnout, secondary traumatic stress, and compassion satisfaction', 'greater self-compassion']","[{'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",43.0,0.0259643,"Compared with the control group, participants in the intervention group also had significantly less loneliness ( F [3, 98] = 7.46; P < .001) and insomnia ( F [3, 120] = 5.77; P < .001) and greater self-compassion ( F [3, 105] = 2.88; P < .05) and self-awareness ( F [3, 120] = 2.42; P < .10). ","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Phillips', 'Affiliation': 'The Phyllis F. Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Volker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Davidson', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'School of Law, The University of Texas at Austin, Austin, TX.'}]",JCO oncology practice,['10.1200/JOP.19.00748'] 365,32169380,Nasal allergen challenge and environmental exposure chamber challenge: A randomized trial comparing clinical and biological responses to cat allergen.,"BACKGROUND The direct-instillation nasal allergen challenge (NAC) and the environmental exposure chamber (EEC) are 2 methods of conducting controlled allergen provocations. The clinical and biological comparability of these methods has not been thoroughly investigated. OBJECTIVE We sought to compare clinical and immunologic responses to cat allergen in NAC versus EEC. METHODS Twenty-four participants were randomized to receive either NAC followed by a 2-day challenge in an EEC or a 2-day challenge in an EEC followed by NAC. Challenges were separated by 28-day washout periods. We measured total nasal symptom scores, peak nasal inspiratory flow, nasal (0-8 hours) and serum cytokines, serum antibodies, peripheral blood antigen-specific T lymphocytes, and gene expression in nasal scrapings. The primary outcome was the total nasal symptom score area under the curve for the first 3 hours after allergen exposure in NAC or after initiation of exposure in EEC. RESULTS Both challenges increased IL-5 and IL-13 in nasal fluids and serum and resulted in altered nasal cell expression of gene modules related to mucosal biology and transcriptional regulation. Changes in gene modules, more so than cytokine measurements, showed significant associations with total nasal symptom score and peak nasal inspiratory flow. Overall, EEC exposure generated larger responses and more early terminations compared with NAC. Although the 2 challenges did not correlate in symptom magnitude or temporality, striking correlations were observed in cytokine levels. CONCLUSIONS Although clinical outcomes of NAC and EEC were temporally different and nonequivalent in magnitude, immunologic responses were similar. Selection of a particular allergen challenge method should depend on considerations of study objectives and cost.",2020,Both challenges increased IL-5 and IL-13 in nasal fluids and serum and resulted in altered nasal cell expression of gene modules related to mucosal biology and transcriptional regulation.,['Twenty-four participants'],"['NAC', 'environmental exposure chamber (EEC', 'Nasal Allergen Challenge and Environmental Exposure Chamber Challenge', 'EEC or a two-day challenge in EEC followed by NAC']","['TNSS area under the curve for the first 3 hours after allergen exposure in NAC', 'IL-5 and IL-13', 'total nasal symptom scores (TNSS), peak nasal inspiratory flow (PNIF), nasal (0-8hours) and serum cytokines, serum antibodies, peripheral blood antigen-specific T-lymphocytes, and gene expression in nasal scrapings']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0444082', 'cui_str': 'Scrapings (specimen)'}]",24.0,0.0301403,Both challenges increased IL-5 and IL-13 in nasal fluids and serum and resulted in altered nasal cell expression of gene modules related to mucosal biology and transcriptional regulation.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Larson', 'Affiliation': 'The Immune Tolerance Network, Bethesda, Md. Electronic address: dlarson@immunetolerance.org.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Inflamax Research Limited, DBA Cliantha Research, Mississauga, Canada.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Salapatek', 'Affiliation': 'Inflamax Research Limited, DBA Cliantha Research, Mississauga, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Couroux', 'Affiliation': 'Inflamax Research Limited, DBA Cliantha Research, Mississauga, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Whitehouse', 'Affiliation': 'Immune Tolerance Network, San Francisco, Calif.'}, {'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Pina', 'Affiliation': 'Rho Federal Systems Division, Durham, NC.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Rho Federal Systems Division, Durham, NC.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Sever', 'Affiliation': 'Rho Federal Systems Division, Durham, NC.'}, {'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Sanda', 'Affiliation': 'Immune Tolerance Network, San Francisco, Calif.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Poyser', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Allio', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Guy W', 'Initials': 'GW', 'LastName': 'Scadding', 'Affiliation': 'MRC and Asthma UK, Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Tielin', 'Initials': 'T', 'LastName': 'Qin', 'Affiliation': 'The Immune Tolerance Network, Bethesda, Md.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'MRC and Asthma UK, Centre in Allergic Mechanisms of Asthma, London, United Kingdom; Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation Repair and Development, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Kwok', 'Affiliation': 'Benaroya Research Institute, Department of Translational Research, Seattle, Wash.'}, {'ForeName': 'Eddie A', 'Initials': 'EA', 'LastName': 'James', 'Affiliation': 'Benaroya Research Institute, Department of Translational Research, Seattle, Wash.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'French', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Lelic', 'Affiliation': 'Human Immunology Testing Suite, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Larché', 'Affiliation': ""McMaster University, Hamilton, Ontario, Canada; Divisions of Clinical Immunology & Allergy and Respirology, Department of Medicine, Firestone Institute of Respiratory Health, The Research Institute, St Joe's Hamilton, Hamilton, Canada.""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Altman', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Wash; Benaroya Research Institute, Systems Immunology Division, Seattle, Wash.'}, {'ForeName': 'Alkis', 'Initials': 'A', 'LastName': 'Togias', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'MRC and Asthma UK, Centre in Allergic Mechanisms of Asthma, London, United Kingdom; Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation Repair and Development, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.02.024'] 366,32182353,Which Components of a Smartphone Walking App Help Users to Reach Personalized Step Goals? Results From an Optimization Trial.,"BACKGROUND The Assistant to Lift your Level of activitY (Ally) app is a smartphone application that combines financial incentives with chatbot-guided interventions to encourage users to reach personalized daily step goals. PURPOSE To evaluate the effects of incentives, weekly planning, and daily self-monitoring prompts that were used as intervention components as part of the Ally app. METHODS We conducted an 8 week optimization trial with n = 274 insurees of a health insurance company in Switzerland. At baseline, participants were randomized to different incentive conditions (cash incentives vs. charity incentives vs. no incentives). Over the course of the study, participants were randomized weekly to different planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt. Primary outcome was the achievement of personalized daily step goals. RESULTS Study participants were more active and healthier than the general Swiss population. Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4]. Charity incentives, self-monitoring prompts, and coping planning did not affect physical activity. Engagement with planning interventions and self-monitoring prompts was low and 30% of participants stopped using the app over the course of the study. CONCLUSIONS Daily cash incentives increased physical activity in the short term. Planning interventions and self-monitoring prompts require revision before they can be included in future versions of the app. Selection effects and engagement can be important challenges for physical-activity apps. CLINICAL TRIAL INFORMATION This study was registered on ClinicalTrials.gov, NCT03384550.",2020,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].",['n = 274 insurees of a health insurance company in Switzerland'],"['planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt', 'incentive conditions (cash incentives vs. charity incentives vs. no incentives']","['physical activity', 'step-goal achievement', 'achievement of personalized daily step goals']","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0007962', 'cui_str': 'Charities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0829464,"Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4].","[{'ForeName': 'Jan-Niklas', 'Initials': 'JN', 'LastName': 'Kramer', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Künzler', 'Affiliation': 'Department of Management, Technology and Economics, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Mishra', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kotz', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Urte', 'Initials': 'U', 'LastName': 'Scholz', 'Affiliation': 'Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elgar', 'Initials': 'E', 'LastName': 'Fleisch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kowatsch', 'Affiliation': 'Institute of Technology Management (ITEM), University of St. Gallen, St. Gallen, Switzerland.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa002'] 367,31492113,TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial.,"BACKGROUND Mild cognitive impairment and mild dementia progressively compromise the ability of people to live independently and can have a negative impact on their quality of life. Within the current European Active and Assisted Living programme (AAL), project TV-AssistDem has been developed to deliver a TV-based platform service to support patients with mild cognitive impairment or mild dementia and provide relief to their caregivers. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The aim of this study is to evaluate the effectiveness of TV-AssistDem to improve quality of life in people with mild cognitive impairment or mild dementia. METHODS This is a 12-month European multicentre randomized controlled trial which will be performed in two countries: Spain and Romania. Two hundred and forty older adults will be recruited using identical inclusion/exclusion criteria. The primary outcome will be the change from baseline of TV-AssistDem on patient quality of life at 12 months. The secondary outcomes will be the changes from baseline of: 1) informal caregiver quality of life, 2) informal caregiver burden, 3) patient treatment adherence, 4) patient treatment compliance, 5) patient functional status, and 6) healthcare cost-effectiveness at 12 months. Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television. The core services of the platform are: 1) Calendar and reminders, 2) Health monitoring and data transmission to a health server and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation; 5) Reminiscences; and 6) Patient and caregiver healthcare education. The analysis will be made following an intention-to-treat procedure. Linear and Generalized Mixed Model analysis will be performed. DISCUSSION We hypothesize that the regular use of TV-AssistDem will result in an improvement in patient quality of life. The uniqueness of this home TV-based intervention lies on its widespread accessibility and its integrative approach to quality of life in people with mild cognitive impairment or mild dementia and their informal caregivers. However, several anticipated challenges will need to be faced: poor engagement and connectivity problems. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03653234 , Date of registration: 31 August 2018.",2019,Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television.,"['two countries: Spain and Romania', 'people with mild cognitive impairment or mild dementia', 'European adults living with mild dementia or mild cognitive impairment (TV-AssistDem', 'people with mild cognitive impairment or mild dementia and their informal caregivers', 'Two hundred and forty older adults will be recruited using identical inclusion/exclusion criteria']","['TV-AssistDem', 'TV-based assistive integrated service']","['changes from baseline of: 1) informal caregiver quality of life, 2) informal caregiver burden, 3) patient treatment adherence, 4) patient treatment compliance, 5) patient functional status, and 6) healthcare cost-effectiveness', 'change from baseline of TV-AssistDem on patient quality of life', 'patient quality of life', 'quality of life']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0034380'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",240.0,0.237904,Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television.,"[{'ForeName': 'Jessica Marian', 'Initials': 'JM', 'LastName': 'Goodman-Casanova', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain. jessica.goodman@ibima.eu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzmán-Parra', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Guerrero', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Vera', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Barnestein-Fonseca', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Cortellessa', 'Affiliation': 'CNR-Italian National Research Council, ISTC, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fracasso', 'Affiliation': 'CNR-Italian National Research Council, ISTC, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Umbrico', 'Affiliation': 'CNR-Italian National Research Council, ISTC, Rome, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Cesta', 'Affiliation': 'CNR-Italian National Research Council, ISTC, Rome, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Toma', 'Affiliation': 'S.C. INGRIJIRI LA DOMICILIU S.R.L., Brasov, Romania.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Boghiu', 'Affiliation': 'S.C. INGRIJIRI LA DOMICILIU S.R.L., Brasov, Romania.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Dewarrat', 'Affiliation': 'Institut multidisciplinaire de science de donnees (IMSD), Les Reussilles, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Triantafyllidou', 'Affiliation': 'Institut multidisciplinaire de science de donnees (IMSD), Les Reussilles, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'MEDEA, Massa, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Dionisio', 'Affiliation': 'MEDEA, Massa, Italy.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Mayoral', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga - Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS), Málaga, Spain.'}]",BMC geriatrics,['10.1186/s12877-019-1267-z'] 368,31500590,Time to move? Factors associated with burden of care among informal caregivers of cognitively impaired older people facing housing decisions: secondary analysis of a cluster randomized trial.,"BACKGROUND Making health-related decisions about loved ones with cognitive impairment may contribute to caregiver burden of care. We sought to explore factors associated with burden of care among informal caregivers who had made housing decisions on behalf of a cognitively impaired older person. METHODS We conducted a secondary analysis within a cluster randomized trial (cRT) conducted in 16 publicly-funded home care service points across the Province of Quebec. The cRT assessed the impact of training home care teams in interprofessional shared decision making (IP-SDM). We assessed burden of care with the Zarit Burden Interview (ZBI) scale. We adapted Pallett's framework to inform our data analysis. This framework posits that factors influencing burden of care among caregivers fall within four domains: (a) characteristics of the caregiver, (b) characteristics of the cognitively impaired older person, (c) characteristics of the relationship between the caregiver and the cognitively impaired older person, and (d) the caregiver's perception of their social support resources. We computed the ZBI score and performed multilevel linear regression modelling. RESULTS Among 296 caregivers included in the dataset, the mean ZBI score was 29.8 (SD = 17.5) out of 88. The typical participant was 62.6 years old (SD = 11.7), female (74.7%), and caring for a mother or father (61.2%). Using multivariate analysis, factors significantly associated with caregiver burden mapped onto: caregiver characteristics (caregivers with higher burden were female, experienced higher decision regret and decisional conflict, preferred that their loved one move into the caregiver's home, into a private nursing home or a mixed private-public nursing home, and had made the decision more recently); relationship characteristics (spouses and children experienced higher burden); and caregiver's perception of social support resources (caregivers who perceived that a joint decision making process had occurred had higher burden). CONCLUSION In line with the proposed framework used, we found that caregiver characteristics, relationship characteristics and caregiver's perception of social support resources were associated with burden of care. Our results will help design interventions to prevent and/or reduce caregivers' burden of care. TRIAL REGISTRATION NCT02244359 . Date of registration: September 18, 2014.",2019,The cRT assessed the impact of training home care teams in interprofessional shared decision making (IP-SDM).,"['informal caregivers of cognitively impaired older people facing housing decisions', 'informal caregivers who had made housing decisions on behalf of a cognitively impaired older person', '296 caregivers included in the dataset, the', '16 publicly-funded home care service points across the Province of Quebec', 'The typical participant was 62.6\u2009years old ']",[],"['burden of care with the Zarit Burden Interview (ZBI) scale', 'mean ZBI score']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0019855', 'cui_str': 'Domiciliary Care'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",296.0,0.356213,The cRT assessed the impact of training home care teams in interprofessional shared decision making (IP-SDM).,"[{'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Boucher', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Haesebaert', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Freitas', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'Marjolaine', 'Initials': 'M', 'LastName': 'Landry', 'Affiliation': 'Department of Nursing of Université du Québec à Trois-Rivières, Quebec, Canada.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Bourassa', 'Affiliation': 'Caregiver Partner, Quebec, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Jordie', 'Initials': 'J', 'LastName': 'Croteau', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'Painchaud-Guérard', 'Initials': 'PG', 'LastName': 'Geneviève', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, and Population Health and Practice-Changing Research Group, Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec, Canada. France.Legare@mfa.ulaval.ca.'}]",BMC geriatrics,['10.1186/s12877-019-1249-1'] 369,31765640,Impact of treatment for fecal incontinence on constipation symptoms.,"OBJECTIVE Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment. STUDY DESIGN This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks. RESULTS At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4). CONCLUSION Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.",2020,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"['Women with at least monthly FI and normal stool consistency', 'Fecal Incontinence on Constipation Symptoms', 'women with fecal incontinence (FI', 'women undergoing treatment for FI with education only', 'women with normal consistency stool']","['placebo', 'placebo plus biofeedback', 'loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback', 'combination loperamide plus biofeedback therapy', 'oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback']","['PAC-SYM scores', 'PAC-SYM global scores', 'constipation symptoms', 'loperamide plus biofeedback', 'FI symptoms', 'loperamide plus education', 'Constipation Symptoms (PAC-SYM) questionnaire', 'global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps', ""St. Mark's (Vaizey) scale"", 'Defecatory symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332530', 'cui_str': 'Normal consistency (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3652856', 'cui_str': 'loperamide, combinations'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0426739', 'cui_str': 'Stool size'}, {'cui': 'C0558921', 'cui_str': 'Rectal symptoms (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0222045'}]",,0.676002,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas at Austin. Austin, TX; University of New Mexico Health Sciences Center, Albuquerque, NM.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1256'] 370,31606589,Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal.,"BACKGROUND Lofexidine is a non-opioid treatment for opioid withdrawal syndrome. Its sympatholytic actions counteract the nor-adrenergic hyperactivity that occurs during abrupt opioid withdrawal. METHODS The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186). ECGs were time-matched to blood sampling for lofexidine concentration and were collected at prespecified timepoints over a 7-day inpatient period. Analyses included mean change-from-baseline QTcF and exposure-response modeling to predict QTcF at relevant lofexidine concentrations. RESULTS A total of 681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis. Most subjects were withdrawing from heroin. During the first 24 h (Days 1-2) post-baseline, small increases in QTcF were observed in all groups: 4.7 ms for lofexidine 2.16 mg, 7.4 ms for lofexidine 2.88 mg and 1.4 ms for placebo. These increases were transient; by Day 4, when lofexidine levels had reached steady-state, QTcF increases were not present. By Day 7, QTcF was decreased from baseline in all groups. Exposure-response modeling predicted <10 ms increases in QTcF at lofexidine concentrations 3 times those obtained at maximal recommended dose. CONCLUSIONS Lofexidine was associated with small, transient QTcF increases. Decreases in QTcF that occurred with higher lofexidine concentrations argue for an indirect QTcF effect, potentially from changes in autonomic tone. Both opioid withdrawal and lofexidine's sympatholytic actions would be expected to alter sympathetic outflow over the 7-day withdrawal.",2019,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).",['681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis'],"['Lofexidine', 'placebo', ""lofexidine's sympatholytic actions"", 'lofexidine']","['cardiac repolarization', 'autonomic tone', 'QTcF', 'QTcF (QT interval, heart-rate corrected, Fridericia formula', 'sympathetic outflow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039051', 'cui_str': 'Sympatholytic Agents'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",681.0,0.161758,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).","[{'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Darpö', 'Affiliation': ""Department of Clinical Sciences, Karolinska Institute, Danderyd's Hospital, 182 88 Stockholm, Sweden. Electronic address: borje.darpo@telia.com.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pirner', 'Affiliation': 'Department of Clinical Research and Medical Affairs, US WorldMeds, LLC, 4441 Springdale Rd, Louisville, KY 40241, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth and Associates, Inc., 450 N Lakeshore Dr, Mundelein, IL 60060, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ferber', 'Affiliation': 'Statistik Georg Ferber GmbH, Cagliostrostrasse 14, 4125 Riehen, Switzerland.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107596'] 371,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961'] 372,31726963,Efficacy of Clopidogrel-Aspirin Therapy for Stroke Does Not Exist in C YP2C19 Loss-of-Function Allele Noncarriers With Overweight/Obesity.,"Background and Purpose- The role of dual-antiplatelet therapy with clopidogrel plus aspirin has been demonstrated to substantially decrease the risk of recurrent stroke among patients with minor stroke and transient ischemic attack. We aimed to determine whether the efficacy of clopidogrel-aspirin therapy among patients with minor stroke / transient ischemic attack was influenced by the stratification of CYP2C19 genotype and body mass index (BMI). Methods- CYP2C19 loss-of-function allele (LoFA) carriers were defined as patients with either LoFA of *2 or *3. Low/normal weight and overweight/obesity was defined as BMI <25 and ≥25 kg/m 2 , respectively. Primary outcome was defined as stroke recurrence at 3 months. Results- In a total of 2933 patients, there were 1726 (58.8%) LoFA carriers and 1275 (43.5%) patients with overweight/obesity (BMI ≥25 kg/m 2 ). Stratified analyses by LoFA carrying status and BMI, hazard ratios (hazard ratios 95% CIs) of the clopidogrel-aspirin therapy for stroke recurrence were 0.90 (0.60-1.36), 0.87 (0.56-1.35), 0.65 (0.39-1.09), and 0.40 (0.22-0.71) among subgroups of LoFA carriers with overweight/obesity, LoFA carriers with low/normal weight, LoFA noncarriers with overweight/obesity, and LoFA noncarriers with low/normal weight, respectively, with P =0.049 for interaction. Conclusions- Efficacy of clopidogrel-aspirin therapy in reducing the risk of stroke recurrence is not present in CYP2C19 LoFA noncarriers with overweight/obesity. Our study suggests that BMI significantly influences the correlation between CYP2C19 genotype and efficacy of clopidogrel-aspirin therapy. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00979589.",2020,Conclusions- Efficacy of clopidogrel-aspirin therapy in reducing the risk of stroke recurrence is not present in CYP2C19 ,"['patients with minor stroke and transient ischemic attack', '2933 patients, there were 1726 (58.8', 'patients with minor stroke / transient ischemic attack', 'LoFA noncarriers with overweight/obesity', 'LoFA carriers and 1275 (43.5%) patients with overweight/obesity (BMI ≥25 kg/m 2 ']","['Methods', 'clopidogrel-aspirin therapy', ' and Purpose', 'clopidogrel plus aspirin', 'Clopidogrel-Aspirin Therapy']","['risk of stroke recurrence', 'Low/normal weight and overweight/obesity', 'stroke recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",2933.0,0.0737186,Conclusions- Efficacy of clopidogrel-aspirin therapy in reducing the risk of stroke recurrence is not present in CYP2C19 ,"[{'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Zimo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Aichun', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (J.M., Z.C., J.X., A.W., L.D., A.C., X.M., H.L., Y.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.026845'] 373,31157583,Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study.,"PURPOSE The KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2-positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE. METHODS Patients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery). RESULTS Of patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8% v 67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5% v 9.9%) and AEs leading to treatment discontinuation (18.4% v 3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment. CONCLUSION Compared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.",2019,"T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs).","['Patients', 'Of patients', 'Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer']","['TCH+P, T-DM1+P', 'TCH+P received adjuvant trastuzumab plus pertuzumab', 'Neoadjuvant Trastuzumab Emtansine and Pertuzumab', 'neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P', 'neoadjuvant T-DM1+P or TCH+P']","['reduced risk of an IDFS event', 'locoregional progression events', 'Overall, grade 3 or greater AEs', 'grade 3 or greater AEs', 'pathologic complete response rate', 'Pathologic complete response', 'event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",444.0,0.300328,"T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs).","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Universidad Complutense, CUBERONC, GEICAM, Madrid, Spain.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Republic of China.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'University of Munich, Munich, Germany.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital 62, Moscow, Russia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Centre René Gauducheau, Saint-Herblain, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'McGill University, Jewish General Hospital Segal Cancer Centre, Montréal, Québec, Canada.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Afenjar', 'Affiliation': 'Translational Research in Oncology, Paris, France.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Spera', 'Affiliation': 'Translational Research in Oncology, Montevideo, Uruguay.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Lopez-Valverde', 'Affiliation': 'PAREXEL International GmbH, Berlin, Germany.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulet', 'Affiliation': 'PAREXEL International GmbH, Berlin, Germany.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Thompson', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Slamon', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00882'] 374,32285047,"Correction: Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose-response trial.","Correction for 'Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose-response trial' by Song Lin et al., Food Funct., 2020, 11, 370-377.",2020,"Correction for 'Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose-response trial' by Song Lin et al., Food Funct.",['adult patients'],['proprietary Lactobacillus casei'],['gastrointestinal adverse reactions'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",,0.0253578,"Correction for 'Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose-response trial' by Song Lin et al., Food Funct.","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn and Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Nobels Väg 12A, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Shanliang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Linyi People's Hospital East Branch, 27 Jiefang East Road, Lanshan District of Linyi, 276000, Shandong province, China.""}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'The Qingdao Central Hospital, 127 Siliu South Road, Qingdao 266000, Shandong province, China.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Hao', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}, {'ForeName': 'Aiguo', 'Initials': 'A', 'LastName': 'Ma', 'Affiliation': 'The College of Public Health, Qingdao University, 38 Dengzhou Road, Qingdao, 266021, Shandong province, China. magfood@qdu.edu.cn.'}]",Food & function,['10.1039/d0fo90017f'] 375,31525083,Long-Term Effect of Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents in Patients With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the BIOSCIENCE Randomized Trial.,"BACKGROUND Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease. METHODS In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years. RESULTS Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94-1.58; P =0.13). Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis at 5 years were similar in patients treated with ultrathin-strut BP-SES and thin-strut DP-EES. After adjustment for potential confounders, there was no significant interaction between vessel size and treatment effect of BP-SES versus DP-EES. CONCLUSIONS We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.",2019,"We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES. ","['Patients', 'With Small Vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention', 'patients undergoing percutaneous coronary revascularization for small vessel disease', 'patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with', '2109 patients, 1234 (59%) were treated for small vessel disease']","['ultrathin-strut versus thin-strut drug-eluting stent', 'Ultrathin-Strut Versus Thin-Strut Drug-Eluting Stents', 'ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES', 'Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES', 'BP-SES or DP-EES', 'durable polymer everolimus-eluting stents (DP-EES']","['target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years', 'Cumulative incidences of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization and definite stent thrombosis', 'target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",2109.0,0.140645,"We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES. ","[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': 'Division of Cardiology, Geneva University Hospitals, Switzerland (J.F.I., M.R., S.N.).'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Switzerland (D.H.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Roffi', 'Affiliation': 'Division of Cardiology, Geneva University Hospitals, Switzerland (J.F.I., M.R., S.N.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tüller', 'Affiliation': 'Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Division of Cardiology, Geneva University Hospitals, Switzerland (J.F.I., M.R., S.N.).'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Muller', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Switzerland (O.M.).'}, {'ForeName': 'Igal', 'Initials': 'I', 'LastName': 'Moarof', 'Affiliation': 'Department of Cardiology, Kantonsspital Aarau, Switzerland (I.M.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital Fribourg, Switzerland (S.C.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Department of Cardiology, Kantonsspital St Gallen, Switzerland (D.W.).'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, Basel University Hospital, Switzerland (C.K.).'}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Department of Cardiology, Kantonsspital Luzern, Switzerland (F.C.).'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Häner', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern University Hospital, Switzerland (J.H., S.W., T.P.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Canada (P.J.).""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern University Hospital, Switzerland (J.H., S.W., T.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern University Hospital, Switzerland (J.H., S.W., T.P.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008024'] 376,32281816,Effects of a family diabetes self-management education intervention on the patients' supporters.,"INTRODUCTION Diabetes self-management education (DSME) programs that engage the families of patients with diabetes have shown to be effective in improving diabetes-related outcomes of the patients. The health effects of these ""family models"" of DSME on participating family members are rarely studied. Opportunity exists for the participating family members to benefit from the healthy lifestyle recommendations offered through such programs. METHOD Using data from a randomized controlled trial to assess the effect of family DSME compared to standard DSME among Marshallese adults with Type 2 diabetes, this study examined baseline to 12-month changes in A1c, body mass index (BMI), food consumption, and physical activity among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions. RESULTS Overall, family member attendance was low. There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups. After controlling for attendance and sociodemographic measures, lowering of BMI was the only significant predictor of not having an A1c level indicative of diabetes at 12 months. DISCUSSION Future research on family DSME should consider ways to improve family member attendance; have them set their own health improvement goals; and integrate healthy lifestyle education, such as healthy eating and being physically active, along with the DSME core content to create an added benefit of diabetes prevention for participating family members. The limitations of this study and recommendations for future research are provided. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[""patients' supporters"", 'Marshallese adults with Type 2 diabetes', 'among participating family members, comparing outcomes of family members based on attended at least 1 (n = 98) versus attended no (n = 44) DSME sessions']","['standard DSME', 'family diabetes self-management education intervention', 'family DSME']","['A1c, BMI, food consumption, and physical activity', 'A1c, body mass index (BMI), food consumption, and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0574386', 'cui_str': 'Marshallese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0207488,"There were no differences in the level of change from baseline to 12 months for A1c, BMI, food consumption, and physical activity between groups.","[{'ForeName': 'Holly C', 'Initials': 'HC', 'LastName': 'Felix', 'Affiliation': 'Fay W. Boozman College of Public Health.'}, {'ForeName': 'M Rachelle', 'Initials': 'MR', 'LastName': 'Narcisse', 'Affiliation': 'Office of Community Health and Research.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Long', 'Affiliation': 'College of Medicine.'}, {'ForeName': 'Pearl A', 'Initials': 'PA', 'LastName': 'McElfish', 'Affiliation': 'College of Medicine.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000470'] 377,32111373,"Impact of intraoperative noise measurement on the surgeon stress and patient outcomes. A prospective, controlled, single-center clinical trial with 664 patients.","BACKGROUND The impact of sound-activated noise meters to decrease the noise level in the operating room is not clear. The aim of this study was to determine whether a sound-activated, visual noise meter would decrease noise levels, decrease postoperative morbidity, and improve surgeons' feelings of well-being. METHODS This prospective, single-center study proceeded in 2 phases. First, sound levels were compared during a 6-month period with noise measurement only and without a visual feedback function. Second, we conducted a subsequent 6-month phase with noise meters providing direct feedback. Surgeon disturbance during the operation was assessed by a questionnaire after each procedure. RESULTS Of the 664 procedures included in this analysis, 447 (67.3%) were in phase 1 and 217 (32.7%) in phase 2. The noise levels in the operating room were decreased by 3.8 dB(A) from 54.6 ± 4.5 dB(A) in phase 1 to 50.8 ± 2.8 dB(A) in phase 2 after intervention with the feedback device (P < .001). During the procedures, there was an increase of 0.7 dB(A) (P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end. There was a correlation between the disturbance of the surgeon and the noise level (P < .001). CONCLUSION The application of a visual noise warning device in an operating room decreased both the noise levels and surgeon stress and may offer sustained decreases in ambient and peak sound levels, potentially leading to improved quality outcomes in visceral surgery.",2020,"(P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end.",['664 patients'],"['sound-activated, visual noise meter', 'intraoperative noise measurement', 'noise meters providing direct feedback', 'visual noise warning device']","['0.7 dB(A', ""postoperative morbidity, and improve surgeons' feelings of well-being"", 'Surgeon disturbance', 'noise levels', 'disturbance of the surgeon and the noise level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0203565,"(P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end.","[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Ukegjini', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland. Electronic address: kristjan.ukegjini@kssg.ch.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kastiunig', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Widmann', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland; Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Warschkow', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steffen', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}]",Surgery,['10.1016/j.surg.2019.12.010'] 378,31470806,"A randomized, crossover study of the acute effects of acarbose and gastric distension, alone and combined, on postprandial blood pressure in healthy older adults.","BACKGROUND Postprandial hypotension (PPH) occurs frequently in the elderly and patients with type 2 diabetes, and lacks a satisfactory treatment. Gastric distension and the α-glucosidase inhibitor, acarbose, may attenuate the postprandial fall in blood pressure (BP) by complementary mechanisms. We aimed to determine whether gastric distension and acarbose have additive effects to attenuate the fall in BP induced by oral sucrose. METHODS Ten healthy older adults (74.0 ± 1.4 yr) had measurements of BP and superior mesenteric artery (SMA) blood flow for 120 min after receiving either (i) the 'study drink' of 100 g sucrose in 300 mL of water (control treatment), (ii) a 300 mL water 'preload' 15 min before the 'study drink' (distension treatment), (iii) 100 mg acarbose dissolved in the 'study drink' (acarbose treatment) or (iv) a 300 ml water 'preload' 15 min before 100 mg acarbose dissolved in the 'study drink' (acarbose and distension treatment). RESULTS The area under the curve (AUC) 0-120min for mean arterial pressure (MAP) was greater (P = 0.005) and the maximum fall in MAP was less (P = 0.006) during treatments with acarbose. Gastric distension did not affect the MAP-AUC 0-120min response to acarbose (P = 0.44) and there was no effect of gastric distension alone (P = 0.68). Both acarbose treatments attenuated the rise in SMA blood flow (P = 0.003), whereas gastric distension had no effect. CONCLUSIONS In healthy older adults, acarbose (100 mg), but not gastric distension, attenuates the fall in BP and rise in SMA blood flow after oral sucrose. The observations support the use of acarbose, but not gastric distension, to attenuate a postprandial fall in BP. TRIAL REGISTRATION The study was retrospectively registered at ( ACTRN12618000152224 ) on February 02nd 2018.",2019,"Gastric distension and the α-glucosidase inhibitor, acarbose, may attenuate the postprandial fall in blood pressure (BP) by complementary mechanisms.","['healthy older adults', 'elderly and patients with type 2 diabetes', ""Ten healthy older adults (74.0\u2009±\u20091.4\u2009yr) had measurements of BP and superior mesenteric artery (SMA) blood flow for 120\u2009min after receiving either (i) the 'study drink' of 100""]","[""acarbose dissolved in the 'study drink' (acarbose and distension treatment"", 'α-glucosidase inhibitor, acarbose', 'acarbose', 'acarbose and gastric distension, alone and combined']","['area under the curve (AUC) 0-120min for mean arterial pressure (MAP', 'SMA blood flow', 'Gastric distension', 'gastric distension', 'fall in BP and rise in SMA blood flow', 'blood pressure (BP', 'postprandial blood pressure']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0162861', 'cui_str': 'Mesenteric Artery, Superior'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C4521688', 'cui_str': 'Dissolve (transformation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017764', 'cui_str': 'Glucosidase (substance)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",10.0,0.0357792,"Gastric distension and the α-glucosidase inhibitor, acarbose, may attenuate the postprandial fall in blood pressure (BP) by complementary mechanisms.","[{'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Trahair', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Phillips', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rayner', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'NHMRC Centre of Research Excellence in Translating Nutritional Science to Good Health, Adelaide Medical School, The University of Adelaide, Level 5 Adelaide Health and Medical Sciences Building, Cnr North Tce and George St, Adelaide, SA, 5005, Australia. karen.jones@adelaide.edu.au.'}]",BMC geriatrics,['10.1186/s12877-019-1251-7'] 379,31470815,"An augmented prescribed exercise program (APEP) to improve mobility of older acute medical patients - a randomized, controlled pilot and feasibility trial.","BACKGROUND There is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study. METHODS We conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions. Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20-30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay. RESULTS Thirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions. There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%. CONCLUSIONS This small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study. TRIAL REGISTRATION German Clinical Trials Register ( DRKS00011262 ). Registered 27 October 2016.",2019,There were no statistically significant differences in mean change scores in any outcome measure.,"['Thirty-five participants were recruited (recruitment rate 20.3', '124 participants would be required to detect a difference of 4 DEMMI points (ES\u2009=\u20090.45) with a power of 80', 'older acute medical patients and (2', 'Intervention group participants (n\u2009', 'older acute medical patients', 'older acute medical patients ', 'older hospital patients', 'Participants were recruited from acute geriatric wards of a general hospital']","['additional exercise sessions', 'usual care, including physiotherapy', 'APEP', 'exercise program (APEP', 'APEP intervention', 'augmented prescribed exercise program (APEP']","['severe adverse events', 'adherence, compliance and safety', 'mobility capacity (de Morton Mobility Index; DEMMI', 'mean change scores', 'walking ability, physical endurance, fear of falling, frailty and length of stay']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0031808', 'cui_str': 'Physical Stamina'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",35.0,0.155072,There were no statistically significant differences in mean change scores in any outcome measure.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany. to.braun@posteo.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grüneberg', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Süßmilch', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Wiessmeier', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Schwenk', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Eggert', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Machleit-Ebner', 'Affiliation': 'Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbH, Clinical Trials Center, Wiescherstraße 24, 44623, Herne, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Harras', 'Affiliation': 'Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbH, Therapeutic management, Wiescherstraße 24, 44623, Herne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiel', 'Affiliation': 'Department of Applied Health Sciences, Division of Physiotherapy, Hochschule für Gesundheit (University of Applied Sciences), Gesundheitscampus 6-8, 44801, Bochum, Germany.'}]",BMC geriatrics,['10.1186/s12877-019-1246-4'] 380,31958446,Aprepitant for Cough Suppression in Advanced Lung Cancer: A Randomized Trial.,"BACKGROUND Although cough is a common and distressing symptom in patients with lung cancer, there is almost no evidence to guide treatment. Aprepitant, a centrally acting neurokinin-1 inhibitor, significantly decreased cough frequency in a pilot study. METHODS Patients with advanced lung cancer and cough lasting over 2 weeks despite a cough suppressant were randomized 1:1 to aprepitant 125 mg orally on day 1 and then 80 mg orally on days 2 to 7 with physician's choice of antitussive; or to physician's choice of antitussive alone. Evaluation was at baseline and on days 3, 7, 9, and 12. The primary end point was subjective cough improvement on day 9, measured by the Visual Analog Scale and Manchester Cough in Lung Cancer Scale. Secondary end points included quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire and the EORTC Lung Cancer-Specific Quality of Life Questionnaire and toxicity. RESULTS Between 2017 and 2018, 128 patients were randomized. Median baseline cough duration was 90 days. Mean Visual Analog Scale scores (in mm) at baseline and day 9 were 68 and 39 in the aprepitant arm and 62 and 49 in the control arm, respectively (P < .001); mean Manchester Cough in Lung Cancer Scale scores at baseline and day 9 were 33 and 23 in the aprepitant arm and 30 and 25 in the control arm, respectively (P < .001). Overall QoL was not significantly different between the two arms; however, aprepitant led to a significant improvement in the cough-specific QoL domain (P = .017). Aprepitant did not increase severe adverse events. CONCLUSIONS Aprepitant led to a significant improvement in cough in advanced lung cancer, without increasing severe side effects. TRIAL REGISTRY Clinical Trials Registry-India; No.: CTRI/2017/05/008691; URL: http://ctri.nic.in.",2020,"Overall QoL was not significantly different between the two arms, however aprepitant led to a significant improvement in the cough-specific QoL domain, P=0.017.","['Patients with advanced lung cancer and cough lasting over two weeks despite a cough suppressant', 'Advanced Lung Cancer', 'lung cancer patients', 'Between 2017 and 2018, 128 patients were randomized']","[""aprepitant 125 mg orally on day one then 80 mg orally on days two to seven with physician's choice of antitussive; or to physician's choice of antitussive alone""]","['cough frequency', 'Mean VAS scores', 'quality of life (QoL) as measured by the EORTC QLQ-C30 and QLQ-LC13 and toxicity', 'Median baseline cough duration', 'cough in advanced lung cancer', 'Overall QoL', 'cough-specific QoL domain', 'subjective cough improvement on day nine, measured by the Visual Analog Scale (VAS) and Manchester Cough in Lung Cancer Scale (MCLCS', 'severe adverse events', 'Mean MCLCS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0003449', 'cui_str': 'Antitussives'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C1331019', 'cui_str': 'aprepitant 125 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0003449', 'cui_str': 'Antitussives'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0222045'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",128.0,0.130671,"Overall QoL was not significantly different between the two arms, however aprepitant led to a significant improvement in the cough-specific QoL domain, P=0.017.","[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Biostatistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute, Navi Mumbai, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Srushti', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Biostatistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute, Navi Mumbai, India.'}, {'ForeName': 'Sadaf A', 'Initials': 'SA', 'LastName': 'Mukadam', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kamesh', 'Initials': 'K', 'LastName': 'Maske', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Ishi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India. Electronic address: kumarprabhashtmh@gmail.com.'}]",Chest,['10.1016/j.chest.2019.11.048'] 381,32273276,Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.,"PURPOSE Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes -expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B). EXPERIMENTAL DESIGN Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates. RESULTS Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7-8.6] and 6.1 (95% CI, 3.5-7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55-1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. CONCLUSIONS Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.",2020,"Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. ","['previously-treated metastatic pancreatic cancer', 'Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease', 'Patients with Pancreatic Cancer']","['Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207', 'GVAX pancreas vaccine (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207']","['adverse event rate', 'CD8 + T cells', 'progression-free survival, safety, tumor responses, CA19-9 responses and immunologic correlates', 'overall survival (OS', 'Objective responses', 'CD68 + myeloid cells', 'median OS']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023859', 'cui_str': 'Listeria'}, {'cui': 'C0380162', 'cui_str': 'mesothelin'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.0916246,"Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. ","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsujikawa', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Nauroth', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Vonderheide', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Fisher', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Considine', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Danilova', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech Inc., Berkeley, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3978'] 382,31984443,"Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.","AIMS/HYPOTHESIS A head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin. METHODS This randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA 1c ≤80 mmol/mol (9.5%) and BMI ≤45 kg/m 2 . Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0-5.0 mmol/l. Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [<3.1 mmol/l] with symptoms); (2) nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms, between 00:01 and 05:59 h); and (3) severe hypoglycaemia. The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period. RESULTS Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300. CONCLUSIONS/INTERPRETATION There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300. TRIAL REGISTRATION ClinicalTrials.gov NCT03078478 FUNDING: This trial was funded by Novo Nordisk (Bagsvaerd, Denmark).",2020,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"['individuals with type 2 diabetes treated with basal insulin', 'excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk', 'insulin-treated patients with type 2 diabetes', 'individuals with type 2 diabetes, aged ≥18\xa0years with HbA 1c ≤80\xa0mmol/mol (9.5%) and BMI ≤45\xa0kg/m 2 ', 'Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the']","['basal insulin with or without oral glucose-lowering drugs', 'insulin degludec versus insulin glargine U300', 'glargine', 'insulin degludec 200\xa0U/ml (degludec U200) and insulin glargine 300\xa0U/ml (glargine U300']","['nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms', 'number of overall symptomatic hypoglycaemic events', 'fasting blood glucose', 'severe hypoglycaemia', 'hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose', 'hypoglycaemia safety', 'Risk of hypoglycaemia', 'rates of nocturnal symptomatic and severe hypoglycaemia', 'rate of overall symptomatic hypoglycaemia', 'rate of nocturnal symptomatic hypoglycaemia', 'number of nocturnal symptomatic events and number of severe hypoglycaemic events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4704833', 'cui_str': 'Secretagogues'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1609.0,0.398525,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, 10140 Campus Point Drive, Suite 200, San Diego, CA, 92121, USA. Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, ON, Canada.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, Division of Endocrinology & Metabolism, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lone N', 'Initials': 'LN', 'LastName': 'Troelsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Ladelund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-019-05080-9'] 383,32278781,"Effect of Venlafaxine on Apnea-Hypopnea Index in Patients With Sleep Apnea: A Randomized, Double-Blind Crossover Study.","BACKGROUND One of the key mechanisms underlying OSA is reduced pharyngeal muscle tone during sleep. Data suggest that pharmacologic augmentation of central serotonergic/adrenergic tone increases pharyngeal muscle tone. RESEARCH QUESTION We hypothesized that venlafaxine, a serotonin-norepinephrine reuptake inhibitor, would improve OSA severity. STUDY DESIGN AND METHODS In this mechanistic, randomized, double-blind, placebo-controlled crossover trial, 20 patients with OSA underwent two overnight polysomnograms ≥ 4 days apart, receiving either 50 mg of immediate-release venlafaxine or placebo before bedtime. Primary outcomes were the apnea-hypopnea index (AHI) and peripheral oxygen saturation (Spo 2 ) nadir, and secondary outcomes included sleep parameters and pathophysiologic traits; with a view toward understanding the impact of venlafaxine on mechanisms underlying OSA. RESULTS Overall, there was no significant difference between venlafaxine and placebo regarding AHI (mean reduction, -5.6 events/h [95% CI, -12.0 to 0.9]; P = .09) or Spo 2 nadir (median increase, +1.0% [-0.5 to 5]; P = .11). Venlafaxine reduced total sleep time, sleep efficiency, and rapid eye movement (REM) sleep, while increasing non-REM stage 1 sleep (P all  < .05). On the basis of exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%; P = .049) and lowered (""worsened"") the predicted arousal threshold (-13%; [P = .02]; ie, more arousable), with no effects on other pathophysiologic traits (P all  ≥ .3). Post hoc analyses further suggested effect modification by arousal threshold (P = .002): AHI improved by 19% in patients with a high arousal threshold (-10.9 events/h [-3.9 to -17.9]) but tended to increase in patients with a low arousal threshold (+7 events/h [-2.0 to 16]). Other predictors of response were elevated AHI and less collapsible upper airway anatomy at baseline (|r| > 0.5, P ≤ .02). INTERPRETATION In unselected patients, venlafaxine simultaneously worsened and improved various pathophysiologic traits, resulting in a zero net effect. Careful patient selection based on pathophysiologic traits, or combination therapy with drugs countering its alerting effects, may produce a more robust response. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT02714400; URL: www.clinicaltrials.gov.",2020,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","['and Methods', 'obstructive sleep apnea (OSA', 'Patients with Sleep Apnea ', '20 OSA patients underwent two', 'patients with a high arousal threshold (-10.9/h']","['venlafaxine', 'Venlafaxine', 'overnight polysomnograms >4days apart receiving either 50mg immediate-release venlafaxine or placebo', 'placebo']","['Apnea Hypopnea Index', 'ventilatory response to arousal', 'total sleep time, sleep efficiency and rapid eye movement (REM) sleep', 'pathophysiological traits', 'apnea hypopnea index (AHI) and SpO 2 nadir; secondary outcomes included sleep parameters and pathophysiological traits with a view towards understanding its impact on mechanisms underlying OSA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",20.0,0.290939,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA; Department of Otorhinolaryngology Head and Neck Surgery, Sleep Medicine Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: liyanruru@aliyun.com.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jen', 'Affiliation': 'Division of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, VIC, Australia; Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}]",Chest,['10.1016/j.chest.2020.02.074'] 384,32277519,Improving emotion recognition in anorexia nervosa: An experimental proof-of-concept study.,"OBJECTIVE Previous research has found increasing evidence for difficulties in emotion recognition ability (ERA) and social cognition in anorexia nervosa (AN), and recent models consider these factors to contribute to the development and maintenance of the disorder. However, there is a lack of experimental studies testing this hypothesis. Therefore, the present proof-of-concept study examined whether ERA can be improved by a single session of a computerized training in AN, and whether this has short-term effects on eating disorder symptoms. METHOD Forty inpatients (22.20 ± 7.15 years) with AN were randomly assigned to receive a single session of computerized training of ERA (TERA) or a sham training (training the recognition of different types of clouds). ERA, self-reported eating disorder symptoms, and body mass index (BMI) were assessed within 3 days before and after training. RESULTS After training, both groups showed improved ERA, reduced self-reported eating disorder symptoms, and an increased BMI. As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms. DISCUSSION ERA can be effectively trained in patients with AN. Moreover, short-term improvements in self-reported eating disorder symptoms provide tentative support for the hypothesis that difficulties in ERA contribute to the maintenance of AN, and that specific trainings of ERA hold promise as an additional component in AN treatment. Future studies are needed to replicate these findings in larger samples, and to investigate long-term effects and transfer into real-world settings.",2020,"As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms. ","['Forty inpatients (22.20\u2009±\u20097.15\u2009years) with AN', 'anorexia nervosa', 'patients with AN']","['computerized training of ERA (TERA) or a sham training (training the recognition of different types of clouds', 'TERA']","['BMI', 'ERA, self-reported eating disorder symptoms, and body mass index (BMI', 'ERA and self-reported eating disorder symptoms', 'improved ERA, reduced self-reported eating disorder symptoms', 'emotion recognition']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}]",40.0,0.0161913,"As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms. ","[{'ForeName': 'Mira A', 'Initials': 'MA', 'LastName': 'Preis', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schlegel', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stoll', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Wally', 'Initials': 'W', 'LastName': 'Wünsch-Leiteritz', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Leiteritz', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brockmeyer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23276'] 385,32277531,Five-year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non-small-cell lung cancer.,"Combination antiprogrammed death 1/programmed death-ligand 1 Ab and platinum-based chemotherapy is standard first-line treatment for advanced non-small-cell lung cancer without targetable oncogene alterations. We describe the long-term safety and efficacy data from a previously reported phase Ib study of nivolumab and chemotherapy. Japanese patients with non-small-cell lung cancer were assigned to a treatment arm based on histology and treatment history. Nivolumab (10 mg/kg, i.v.) and chemotherapy (4 arms) were given every 3 weeks: arm A, 4 cycles of cisplatin and gemcitabine (first-line); arm B, 4 cycles of cisplatin and pemetrexed followed by pemetrexed maintenance therapy (first-line); arm C, 4-6 cycles of carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); and arm D, docetaxel (second- or third-line). Study treatments were continued every 3 weeks as maintenance therapy until disease progression. Minimum follow-up period was 57.9 months. Median progression-free survival (median [range, plus sign indicates censored data]) was 6.3 (0.7+-47.8), 11.8 (1.4-65.1+), 40.7 (5.3-60.8+), and 3.2 (1.9-10.9) months, and 5-year progression-free survival was observed in 0/6, 1/6, 1/6, and 0/6 patients in arms A, B, C, and D, respectively. Median overall survival was 13.2 (11.0-55.4), 28.5 (14.6-66.2+), not reached (24.2-67.4+), and 12.5 (9.8-16.9) months; the number of patients surviving 5 years were 0/6, 1/6, 4/6, and 0/6 in arms A, B, C, and D, respectively. No unexpected severe adverse events or treatment-related deaths occurred. Nivolumab and platinum-based chemotherapy combinations showed long-term tolerability. A moderate proportion of patients in arm C showed 5-year progression-free and overall survival.",2020,No unexpected severe adverse events or treatment-related deaths occurred.,"['advanced non-small-cell lung cancer', 'Japanese patients with non-small-cell lung cancer']","['Nivolumab', 'Combination anti-programmed death 1/programmed death-ligand 1 antibody and platinum-based chemotherapy', 'nivolumab and chemotherapy', 'cisplatin and pemetrexed followed by pemetrexed maintenance therapy', 'chemotherapy', 'carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first-line); arm D, docetaxel (second- or third-line', 'Nivolumab and platinum-based chemotherapy combinations', 'cisplatin and gemcitabine']","['5-year progression-free and overall survival', 'severe adverse events', 'Median overall survival', '5-year progression-free survival', 'long-term tolerability', 'Median progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.065678,No unexpected severe adverse events or treatment-related deaths occurred.,"[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Oncology Clinical Development Planning 1, Ono Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'Tomohide', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ""Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.""}]",Cancer science,['10.1111/cas.14410'] 386,31929405,Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial.,"BACKGROUND In the Promoting Maternal and Infant Survival Everywhere (PROMISE) trial, tenofovir disoproxil fumarate (TDF) use was associated with moderate or severe adverse pregnancy/neonatal outcomes. This study characterized tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations in dried blood spots (DBS) and assessed association between severe adverse pregnancy/neonatal outcomes and TFV-DP concentration. METHODS Retrospective case-control study of PROMISE trial arm-C women randomized to receive TDF, FTC, and ritonavir-boosted lopinavir (LPV/r), who took at least 1 dose of TDF + FTC and had week-4 postrandomization DBS drawn before delivery. Cases, defined as severe adverse pregnancy/neonatal outcomes (very preterm delivery before 34 weeks of gestation, stillbirth ≥20 weeks of gestation, or infant death before 14 days-of-age), were matched to controls (1:2 ratio) by site and gestational age at entry. Week 4 and week 8 DBS samples were assayed for TFV-DP and FTC-TP by liquid chromatography and tandem mass spectrometry. Associations were tested using Wilcoxon rank test and conditional logistic regression. RESULTS Of 447 PROMISE arm-C women, 33 met case definitions, and overall, 22 cases and 44 controls were analyzed. Median (interquartile range) concentrations of TFV-DP at weeks 4 and 8 were 706 (375-1023) fmol/punch and 806 (414-1265) fmol/punch, respectively. Odds ratio (95% confidence interval) for severe adverse pregnancy/neonatal outcome with natural log of TFV-DP concentrations as the predictor were 1.27 (0.74 to 2.18) and 1.74 (0.66 to 4.60) at weeks 4 and 8, respectively. Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. CONCLUSIONS TFV-DP concentrations in DBS appeared not to be associated with severe adverse pregnancy/neonatal outcomes, although sample size was limited.",2020,"Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. ",['and Severe Adverse Pregnancy Outcomes'],"['tenofovir disoproxil fumarate (TDF', 'TDF, FTC, and ritonavir-boosted lopinavir (LPV/r), who took at least 1 dose of TDF + FTC', 'Tenofovir Diphosphate and Emtricitabine Triphosphate', 'tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP', 'Tenofovir Diphosphate']","['Median (interquartile range) concentrations of FTC-TP', 'severe adverse pregnancy/neonatal outcomes (very preterm delivery before 34 weeks of gestation, stillbirth ≥20 weeks of gestation, or infant death', 'Odds ratio', 'severe adverse pregnancy/neonatal outcome with natural log of TFV-DP concentrations', 'Median (interquartile range) concentrations of TFV-DP']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0146894', 'cui_str': 'triphosphate'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0549159', 'cui_str': 'Infant Death'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]",447.0,0.220524,"Median (interquartile range) concentrations of FTC-TP at weeks 4 and 8 were 0.27 (0.05-0.36) pmol/punch and 0.29 (0.05-0.40) pmol/punch, respectively. ","[{'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Aizire', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Brooks', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Division of Neonatology, School of Medicine, Boston University, Boston, MA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Flynn', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kiser', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Division of Prevention, Care & Treatment, Office of HIV/AIDS, United States Agency for International Development (USAID), Arlington, VA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Mae', 'Initials': 'M', 'LastName': 'Cababasay', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002247'] 387,32271718,Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis.,"BACKGROUNDNovel therapeutic approaches are critically needed for Staphylococcus aureus bloodstream infections (BSIs), particularly for methicillin-resistant S. aureus (MRSA). Exebacase, a first-in-class antistaphylococcal lysin, is a direct lytic agent that is rapidly bacteriolytic, eradicates biofilms, and synergizes with antibiotics.METHODSIn this superiority-design study, we randomly assigned 121 patients with S. aureus BSI/endocarditis to receive a single dose of exebacase or placebo. All patients received standard-of-care antibiotics. The primary efficacy endpoint was clinical outcome (responder rate) on day 14.RESULTSClinical responder rates on day 14 were 70.4% and 60.0% in the exebacase + antibiotics and antibiotics-alone groups, respectively (difference = 10.4, 90% CI [-6.3, 27.2], P = 0.31), and were 42.8 percentage points higher in the prespecified exploratory MRSA subgroup (74.1% vs. 31.3%, difference = 42.8, 90% CI [14.3, 71.4], ad hoc P = 0.01). Rates of adverse events (AEs) were similar in both groups. No AEs of hypersensitivity to exebacase were reported. Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics-alone groups, respectively, with a notable difference in MRSA patients (3.7% vs. 25.0%, difference = -21.3, 90% CI [-45.1, 2.5], ad hoc P = 0.06). Among MRSA patients in the United States, median length of stay was 4 days shorter and 30-day hospital readmission rates were 48% lower in the exebacase-treated group compared with antibiotics alone.CONCLUSIONSThis study establishes proof of concept for exebacase and direct lytic agents as potential therapeutics and supports conduct of a confirmatory study focused on exebacase to treat MRSA BSIs.TRIAL REGISTRATIONClinicaltrials.gov NCT03163446.FUNDINGContraFect Corporation.",2020,"Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics alone groups, respectively, with a notable difference in MRSA (3.7% vs. 25.0%, difference= -21.3, 90% CI [-45.1, 2.5], ad hoc p-value=0.06).",['121 patients with S. aureus BSI/endocarditis to receive a single dose of'],"['MRSA', 'standard-of-care antibiotics', 'exebacase or placebo']","['30-day hospital readmission rates', 'Rates of adverse events (AEs', 'median length-of-stay', 'MRSA', 'mortality rates', 'clinical outcome (responder rate) at Day 14.RESULTSClinical responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",121.0,0.153962,"Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics alone groups, respectively, with a notable difference in MRSA (3.7% vs. 25.0%, difference= -21.3, 90% CI [-45.1, 2.5], ad hoc p-value=0.06).","[{'ForeName': 'Vance G', 'Initials': 'VG', 'LastName': 'Fowler', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stat Consulting, Guerneville, California, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Lipka-Diamond', 'Affiliation': 'Lipka Consulting, Mullica Hill, New Jersey, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Schuch', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Pomerantz', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jáuregui-Peredo', 'Affiliation': 'Mercy Health-St. Vincent Medical Center, Toledo, Ohio, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bressler', 'Affiliation': 'Infectious Disease Specialists of Atlanta, Georgia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, California, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Rupp', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Zervos', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Cassino', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}]",The Journal of clinical investigation,['10.1172/JCI136577'] 388,31858186,"An exploratory, randomised, placebo-controlled, 14 day trial of the soluble guanylate cyclase stimulator praliciguat in participants with type 2 diabetes and hypertension.","AIMS/HYPOTHESIS Praliciguat (IW-1973), a soluble guanylate cyclase stimulator, amplifies nitric oxide signalling. This exploratory trial investigated the safety, tolerability, pharmacokinetic profile and pharmacodynamic effects of praliciguat in individuals with type 2 diabetes and hypertension. METHODS This Phase IIA, double-blind, placebo-controlled trial investigated praliciguat in 26 participants with type 2 diabetes and hypertension on stable glucose- and BP-lowering therapies. Participants were randomly allocated in a 3:5:5 ratio to three groups: placebo (n = 6), praliciguat 40 mg once daily for days 1-14 (n = 10), or praliciguat 20 mg twice daily for days 1-7 then 40 mg once daily for days 8-14 (n = 10). Assessments were made in clinic and included treatment-emergent adverse events, pharmacokinetics, metabolic variables, 24 h BP and heart rate, platelet function, reactive hyperaemia index (RHI) and plasma biomarkers. Participants, the sponsor, the investigator and clinic study staff (except designated pharmacy personnel) were blinded to group assignment. RESULTS Participants treated for 14 days with praliciguat had least-square mean change-from-baseline differences vs placebo (95% CI) of -0.7 (-1.8, 0.4) mmol/l for fasting plasma glucose, -0.7 (-1.1, -0.2) mmol/l for total cholesterol, -0.5 (-1.0, -0.1) mmol/l for LDL-cholesterol, -23 (-56, 9) for HOMA-IR in those not being treated with insulin, and -5 (-10, 1) mmHg and 3 (-1, 6) beats/min for average 24 h mean arterial pressure and heart rate, respectively. Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated. Praliciguat did not affect platelet function or RHI. Among exploratory biomarkers, plasma levels of asymmetric dimethylarginine decreased in praliciguat vs placebo recipients. CONCLUSIONS/INTERPRETATION In participants with type 2 diabetes and hypertension on standard therapies, over 14 days praliciguat was well tolerated, except for a single SAE, and showed positive trends in metabolic and BP variables. These results support further clinical investigation of praliciguat. TRIAL REGISTRATION ClinicalTrials.gov NCT03091920. FUNDING This trial was funded by Cyclerion Therapeutics.",2020,"Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated.","['participants with type 2 diabetes and hypertension', 'individuals with type 2 diabetes and hypertension', 'Participants, the sponsor, the investigator and clinic study staff (except designated pharmacy personnel', '26 participants with type 2 diabetes and hypertension on stable glucose- and BP-lowering therapies']","['placebo', 'soluble guanylate cyclase stimulator praliciguat']","['fasting plasma glucose', 'plasma levels of asymmetric dimethylarginine', 'safety, tolerability, pharmacokinetic profile and pharmacodynamic effects', 'platelet function or RHI', 'adverse events, pharmacokinetics, metabolic variables, 24\xa0h BP and heart rate, platelet function, reactive hyperaemia index (RHI) and plasma biomarkers', 'mean arterial pressure and heart rate', 'HOMA-IR', 'tolerated']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",26.0,0.58247,"Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hanrahan', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA. JHanrahan@Cyclerion.com.'}, {'ForeName': 'Jelena P', 'Initials': 'JP', 'LastName': 'Seferovic', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Wakefield', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Phebe J', 'Initials': 'PJ', 'LastName': 'Wilson', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chickering', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Carlson', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Zimmer', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Frelinger', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA, USA.""}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Ironwood Pharmaceuticals, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Currie', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'G Todd', 'Initials': 'GT', 'LastName': 'Milne', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}]",Diabetologia,['10.1007/s00125-019-05062-x'] 389,32035124,Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.,"People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.",2020,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"['people living with HIV', 'People living with HIV (PWH']","['ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation', 'ABCS']",['change in ASCVD risk'],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0702008,People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts.,"[{'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'Clinical Directors Network (CDN), Community-Engaged Research, The Rockefeller University Center for Clinical and Translational Science, New York, NY.'}, {'ForeName': 'Amneris Esther', 'Initials': 'AE', 'LastName': 'Luque', 'Affiliation': 'Infectious Diseases and Geographic Medicine, HIV Program at Parkland Health and Hospital System, Community Prevention and Intervention Unit, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mechelle', 'Initials': 'M', 'LastName': 'Sanders', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Carroll', 'Affiliation': 'Department of Family Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cassells', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Tameir', 'Initials': 'T', 'LastName': 'Holder', 'Affiliation': 'Clinical Directors Network, Inc. (CDN), New York, NY.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fiscella', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, NY. Electronic address: Kevin_fiscella@urmc.rochester.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.003'] 390,31464588,Effectiveness of a group-based psychosocial program to prevent depression and anxiety in older people attending primary health care centres: a randomised controlled trial.,"BACKGROUND Evidence about the effectiveness of psychosocial interventions to reduce the incidence of depression and anxiety and promote subjective well-being in older people is limited, particularly in Latin-American countries. This study thus aims to assess a program specifically designed to address this issue in persons aged 65 to 80 and attending primary health care centres. METHOD Older people who use primary care centres are to be randomly assigned to the program or to a control group. Only independent users will be included; those having had a major depressive disorder or an anxiety disorder in the last 6 months will be excluded. The program is group based; it includes cognitive stimulation, expansion of social support networks and cognitive behaviour strategies. Depressive and anxiety symptoms and disorders, as well as psychological well-being, will be assessed using standardised instruments, once before implementing the program and later, after 18 and 36 weeks. DISCUSSION Primary care is a setting where interventions to improve mental health can be beneficial. Providing evidence-based programs that work with older people is a priority for public mental health. TRIAL REGISTRATION A protocol for this study has been registered prospectively at ISRCTN registry on 25 July 2018. Identifier: ISRCTN32235611 .",2019,"Depressive and anxiety symptoms and disorders, as well as psychological well-being, will be assessed using standardised instruments, once before implementing the program and later, after 18 and 36 weeks. ","['Older people who use primary care centres', 'persons aged 65 to 80 and attending primary health care centres', 'older people attending primary health care centres', 'registry on 25 July 2018']","['group-based psychosocial program', 'psychosocial interventions']","['Depressive and anxiety symptoms and disorders', 'depression and anxiety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0933794,"Depressive and anxiety symptoms and disorders, as well as psychological well-being, will be assessed using standardised instruments, once before implementing the program and later, after 18 and 36 weeks. ","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saldivia', 'Affiliation': 'Dpto. de Psiquiatria y Salud Mental Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Inostroza', 'Affiliation': 'Dpto. de Psiquiatria y Salud Mental Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bustos', 'Affiliation': 'Dpto. de Psiquiatria y Salud Mental Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Rincón', 'Affiliation': 'Dpto. de Psicologia Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Aslan', 'Affiliation': 'Dpto. de Psicologia Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Vasily', 'Initials': 'V', 'LastName': 'Bühring', 'Affiliation': 'Dpto. de Psicologia Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farhang', 'Affiliation': 'Dpto. de Psicologia Universidad de Concepcion, Concepcion, Chile.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College of London, London, England.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Cova', 'Affiliation': 'Dpto. de Psicologia Universidad de Concepcion, Concepcion, Chile. fecova@udec.cl.'}]",BMC geriatrics,['10.1186/s12877-019-1255-3'] 391,32271671,Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx.,"PURPOSE Cancer-related cognitive impairment (CRCI) is common during adjuvant chemotherapy and may persist. TAILORx provided a novel opportunity to prospectively assess patient-reported cognitive impairment among women with early breast cancer who were randomly assigned to chemoendocrine therapy (CT+E) versus endocrine therapy alone (E), allowing us to quantify the unique contribution of chemotherapy to CRCI. METHODS Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX were randomly assigned to CT+E or E. Cognitive impairment was assessed among a subgroup of 552 evaluable women using the 37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire, administered at baseline, 3, 6, 12, 24, and 36 months. The FACT-Cog included the 20-item Perceived Cognitive Impairment (PCI) scale, our primary end point. Clinically meaningful changes were defined a priori and linear regression was used to model PCI scores on baseline PCI, treatment, and other factors. RESULTS FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups. The magnitude of PCI change scores was greater for CT+E than E at 3 months, the prespecified primary trial end point, and at 6 months, but not at 12, 24, and 36 months. Tests of an interaction between menopausal status and treatment were nonsignificant. CONCLUSION Adjuvant CT+E is associated with significantly greater CRCI compared with E at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to E, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.",2020,"RESULTS FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","['Women', '552 evaluable women using the', 'women with early breast cancer', 'Women with a 21-gene recurrence score of 11 to 25 enrolled in TAILORX']","['37-item Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire', 'chemoendocrine therapy (CT+E) versus endocrine therapy alone (E', 'Endocrine Therapy', 'Chemoendocrine Therapy', 'Adjuvant CT+E', 'CT+E', 'TAILORx']","['FACT-Cog PCI scores', '20-item Perceived Cognitive Impairment (PCI) scale', 'Cognitive Impairment', 'PCI change scores', 'CRCI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",552.0,0.0961332,"RESULTS FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months compared with baseline for both groups.","[{'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'McMaster University, Canadian Cancer Trials Group, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin Madison, Carbone Cancer Center, Madison, WI.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'The University of Michigan Rogel Cancer Center, Ann Arbor, MI.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Virginia Commonwealth University Massey Cancer Center Minority/Underserved National Cancer Institute Community Oncology Research Program, Richmond, VA.'}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Worta J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University, Stanford, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01866'] 392,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography. Objective To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts. Design, Setting, and Participants Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019. Exposures All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias. Main Outcomes and Measures The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity. Results Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15). Conclusions and Relevance Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome. Trial Registration ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572'] 393,31950229,How conclusive is the CONCLUDE trial?,"The development of basal insulin analogues has reduced the risk of hypoglycaemia in insulin-treated individuals with type 2 diabetes. Insulin degludec and insulin glargine 300 U/ml (glargine U300) represent an evolution of basal insulin analogues, both of them reducing the risk of hypoglycaemia as compared with that associated with glargine U100. However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained. In the CONCLUDE trial, 1609 individuals with type 2 diabetes were randomised to either degludec 200 U/ml (degludec U200) or glargine U300. In this issue of Diabetologia (https://doi.org/10.1007/s00125-019-05080-9) the investigators report that during the maintenance period, HbA 1c improved to a similar extent in the two groups with no significant difference in the rate of overall hypoglycaemia (the primary endpoint of the study), while rates of nocturnal symptomatic and severe hypoglycaemia (secondary endpoints) were lower with degludec U200 than with glargine U300. These results, although of great interest to the clinician, need to be carefully interpreted as they cannot be considered as conclusive. First, the primary endpoint was not met and, therefore, analyses of secondary endpoints remain exploratory. Even assuming that degludec is superior to glargine in reducing the risk of hypoglycaemia, the mechanism(s) accounting for such an advantage remain elusive and potential differences in pharmacokinetics and pharmacodynamics difficult to appreciate because of methodological issues. The study design had to be amended because of lack of reliability of the glucometers initially used in the trial, particularly in the low blood glucose ranges, so the potential implications of these changes in the subsequent conduct of the trial cannot be excluded. Finally, comparison with the BRIGHT trial, the only other available head-to-head study, is complicated by differences between the two studies in the primary endpoint (HbA 1c reduction vs reduction of the risk of hypoglycaemia), study population (insulin-experienced vs insulin-naive) and concomitant glucose-lowering medications. In spite of all this, CONCLUDE teaches us an important lesson regarding the need, particularly in the clinical setting, to monitor the reliability of the glucometers the diabetic individual uses to adjust his/her insulin dose. Insufficient precision or inappropriate use of the glucometer can easily offset any minute advantage a new insulin can offer with respect to glycaemic control and risk of hypoglycaemia.",2020,"However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained.",['1609 individuals with type 2 diabetes'],"['glargine', 'Insulin degludec and insulin glargine 300', 'glargine U300']","['risk of hypoglycaemia), study population (insulin-experienced vs insulin-naive) and concomitant glucose-lowering medications', 'risk of hypoglycaemia', 'rates of nocturnal symptomatic and severe hypoglycaemia', 'rate of overall hypoglycaemia']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1609.0,0.0453593,"However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical & Experimental Medicine, Section of Diabetes, University of Pisa, Nuovo Ospedale Santa Chiara, Via Paradisa, 2, 56124, Pisa, Italy. stefano.delprato@med.unipi.it.'}]",Diabetologia,['10.1007/s00125-020-05086-8'] 394,31960071,"Vascular improvements in individuals with type 2 diabetes following a 1 year randomised controlled exercise intervention, irrespective of changes in cardiorespiratory fitness.","AIMS/HYPOTHESIS Vascular changes in individuals with type 2 diabetes mellitus majorly contribute to the development of cardiovascular disease. Increased cardiorespiratory fitness (CRF) has been associated with improvements in vascular health. Although CRF tends to improve with exercise training, there remains a portion of participants with little or no improvement. Given the importance of vascular function in individuals with type 2 diabetes, we assessed whether individuals who failed to improve CRF following a 1 year exercise intervention also failed to improve arterial stiffness and structural indices. METHODS Individuals with type 2 diabetes with no major micro- and macrovascular complications and aged between 30 and 75 years old (n = 63) participated in a three-arm, 1 year, randomised controlled exercise intervention in Lisbon, Portugal. The study involved a non-exercise control group, a moderate continuous training combined with resistance training (RT) group and a high-intensity interval training with RT group. Allocation of participants into the intervention and control groups was done using a computer-generated list of random numbers. An improvement in CRF was defined as a change in [Formula: see text] ≥5%. Vascular stiffness and structural indices were measured using ultrasound imaging and applanation tonometry. Generalised estimating equations were used to compare changes in vascular measures across individuals in the control group (n = 22) and those in the exercise groups who either had improved CRF (CRF responders; n = 14) or whose CRF did not improve (CRF non-responders; n = 27) following 1 year of exercise training. RESULTS Compared with the control group, exercisers, with and without improvements in CRF, had decreased carotid intima-media thickness (IMT) (CRF responders: β = -2.84 [95% CI -5.63, -0.04]; CRF non-responders: β = -5.89 [95% CI -9.38, -2.40]) and lower-limb pulse wave velocity (PWV) (CRF responders: β = -0.14 [95% CI -0.25, -0.03]; CRF non-responders: β = -0.14 [95% CI -0.25, -0.03]), the latter being an indicator of peripheral arterial stiffness. Only CRF responders had decreased PWV of the upper limb compared with control participants (β = -0.12 [95% CI -0.23, -0.01]). As for central stiffness, CRF non-responders had increased aortic PWV compared with CRF responders (β = 0.19 [95% CI 0.07, 0.31]), whereas only the CRF non-responders had altered carotid distensibility coefficient compared with the control group (β = 0.00 [95% CI 3.01 × 10 -5 , 0.00]). No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05). CONCLUSIONS/INTERPRETATION Regardless of improvements in CRF, individuals with type 2 diabetes had significant improvements in carotid IMT and lower-limb arterial stiffness following a 1 year exercise intervention. Thus, a lack of improvement in CRF following exercise in people with type 2 diabetes does not necessarily entail a lack of improvement in vascular health. TRIAL REGISTRATION ClinicalTrials.gov NCT03144505 FUNDING: This work was supported by fellowships from the Portuguese Foundation for Science and Technology. This work is also financed by a national grant through the Fundação para a Ciência e Tecnologia (FCT), within the unit I&D 472.",2020,"No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05). ","['individuals with type 2 diabetes following a 1\xa0year randomised', 'people with type 2 diabetes', 'CRF non-responders', 'individuals with type 2 diabetes mellitus', 'Individuals with type 2 diabetes with no major micro- and macrovascular complications and aged between 30 and 75\xa0years old (n\u2009=\u200963) participated in a three-arm, 1\xa0year, randomised', 'individuals with type 2 diabetes']","['moderate continuous training combined with resistance training (RT) group and a high-intensity interval training with RT group', 'controlled exercise intervention', 'controlled exercise intervention in Lisbon, Portugal']","['carotid intima-media thickness (IMT', 'carotid IMT and lower-limb arterial stiffness', 'PWV of the upper limb', 'lower-limb pulse wave velocity (PWV) (CRF responders', 'carotid distensibility coefficient', 'Increased cardiorespiratory fitness (CRF', 'arterial stiffness and structural indices', 'aortic PWV', 'CRF', 'Vascular stiffness and structural indices', 'Vascular improvements']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}]","[{'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0867885,"No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05). ","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hetherington-Rauth', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Magalhães', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Pedro B', 'Initials': 'PB', 'LastName': 'Júdice', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Melo', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal. lsardinha@fmh.ulisboa.pt.'}]",Diabetologia,['10.1007/s00125-020-05089-5'] 395,30585373,Acute tryptophan loading decreases functional connectivity between the default mode network and emotion-related brain regions.,"It has been shown that the functional architecture of the default mode network (DMN) can be affected by serotonergic challenges and these effects may provide insights on the neurobiological bases of depressive symptomatology. To deepen our understanding of this possible interplay, we used a double-blind, randomized, cross-over design, with a control condition and two interventions to decrease (tryptophan depletion) and increase (tryptophan loading) brain serotonin synthesis. Resting-state fMRI from 85 healthy subjects was acquired for all conditions 3 hr after the ingestion of an amino acid mixture containing different amounts of tryptophan, the dietary precursor of serotonin. The DMN was derived for each participant and session. Permutation testing was performed to detect connectivity changes within the DMN as well as between the DMN and other brain regions elicited by the interventions. We found that tryptophan loading increased tryptophan plasma levels and decreased DMN connectivity with visual cortices and several brain regions involved in emotion and affect regulation (i.e., putamen, subcallosal cortex, thalamus, and frontal cortex). Tryptophan depletion significantly reduced tryptophan levels but did not affect brain connectivity. Subjective ratings of mood, anxiety, sleepiness, and impulsive choice were not strongly affected by any intervention. Our data indicate that connectivity between the DMN and emotion-related brain regions might be modulated by changes in the serotonergic system. These results suggest that functional changes in the brain associated with different brain serotonin levels may be relevant to understand the neural bases of depressive symptoms.",2019,"We found that tryptophan loading increased tryptophan plasma levels and decreased DMN connectivity with visual cortices and several brain regions involved in emotion and affect regulation (i.e., putamen, subcallosal cortex, thalamus, and frontal cortex).",['85 healthy subjects'],['tryptophan'],"['tryptophan plasma levels', 'tryptophan levels', 'Subjective ratings of mood, anxiety, sleepiness, and impulsive choice', 'DMN connectivity with visual cortices and several brain regions involved in emotion and affect regulation (i.e., putamen, subcallosal cortex, thalamus, and frontal cortex']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0041249', 'cui_str': 'L-tryptophan'}]","[{'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0016733', 'cui_str': 'Frontal Cortex'}]",85.0,0.0434879,"We found that tryptophan loading increased tryptophan plasma levels and decreased DMN connectivity with visual cortices and several brain regions involved in emotion and affect regulation (i.e., putamen, subcallosal cortex, thalamus, and frontal cortex).","[{'ForeName': 'Yacila I', 'Initials': 'YI', 'LastName': 'Deza-Araujo', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Philipp T', 'Initials': 'PT', 'LastName': 'Neukam', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marxen', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dirk K', 'Initials': 'DK', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Henle', 'Affiliation': 'Institute of Food Chemistry, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Smolka', 'Affiliation': 'Department of Psychiatry and Neuroimaging Center, Technische Universität Dresden, Dresden, Germany.'}]",Human brain mapping,['10.1002/hbm.24494'] 396,32276980,A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects.,"The human oral cavity is a complex ecosystem, and the alterations in salivary microbial communities are associated with both oral and nonoral diseases. The Mediterranean diet (MD) is a healthy dietary pattern useful for both prevention and treatment of several diseases. To further explore the effects of the MD on human health, in this study, we investigated the changes in the salivary microbial communities in overweight/obese subjects after an individually tailored MD-based nutritional intervention. Healthy overweight and obese subjects were randomized between two intervention groups. The MD group (Med-D group) increased their MD adherence during 8 weeks of intervention while the control diet (control-D) group did not change their dietary habits. The salivary microbiota was assessed at baseline and after 4 and 8 weeks of intervention. Despite no observed changes in the overall salivary microbiota composition, we found a significant decrease in the relative abundances of species-level operational taxonomic units annotated as Porphyromonas gingivalis , Prevotella intermedia , and Treponema denticola in the Med-D group compared to that in the control-D group after 8 weeks of intervention, which are known to be associated with periodontal disease. Such variations were significantly linked to dietary variables such as MD adherence rates and intakes of animal versus vegetable proteins. In addition, increased levels of Streptococcus cristatus were observed in the Med-D group, which has been reported as an antagonistic taxon inhibiting P. gingivalis gene expression. Our findings suggest that an MD-based nutritional intervention may be implicated in reducing periodontal bacteria, and an MD may be a dietary strategy supportive of oral homeostasis. IMPORTANCE Changes in dietary behavior with increased adherence to a Mediterranean diet can determine a reduction of periodontopathogenic bacterial abundances in the saliva of overweight subjects with cardiometabolic risk due to an unhealthy lifestyle, without any change in individual energy intake, nutrient intake, and physical activity.",2020,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"['overweight and obese subjects', 'Healthy overweight and obese subjects', 'overweight/obese subjects after an individually tailored MD-based nutritional intervention']","['Mediterranean diet intervention', 'Mediterranean diet (MD', 'MD']","['salivary microbiota', 'overall salivary microbiota composition', 'salivary periodontopathogenic bacteria', 'levels of Streptococcus cristatus', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318141', 'cui_str': 'Streptococcus cristatus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0139182,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"[{'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it.'}]",Applied and environmental microbiology,['10.1128/AEM.00777-20'] 397,32272458,Refinement of a protocol to induce reliable muscle cramps in the abductor hallucis.,"OBJECTIVE To test the reliability of immediate replication of muscle cramp characteristics induced with different electrical stimulation protocols. APPROACH Five (age 33.8 ± 5.7 y, 60% male) and ten (age 47.4 ± 11.7 y, 60% male) participants completed independent discovery and validation cohorts, respectively. This was to identify a protocol that resulted in consistent muscle cramp characteristics (discovery), and to examine the test-retest reliability of the identified protocol (validation). Electrical stimulation (150 burst) at abductor hallucis motor-point was used to induce muscle cramps with 4 Hz increments in stimulation frequency (8-32 Hz) or until muscle cramp was first evident, followed by refinement (2 and 1 Hz) until at least two muscle cramps occurred. This defined the cramp threshold frequency, and concurrent electromyogram activity and duration of the cramp were quantified. The discovery cohort involved three separate randomised sessions where intervals between stimulation was 60, 90, and 120 s respectively. In each session, four randomised electrical stimulation protocols were completed. Stimulation current was fixed at 10, 20, and 30% higher than m-wave stimulation current (protocols 1-3 respectively), or randomised within 4 Hz steps (protocol 4) to minimise any order effect. MAIN RESULTS We were able to immediately replicate tolerable muscle cramp at least twice. Discovery cohort demonstrated (i) incremental changes in stimulation frequency (protocols 1-3 vs. protocol 4, i.e. order effect), and (ii) changes in stimulation current with differing protocols did not significantly alter the prevailing muscle cramp characteristics, and (iii) defining the muscle cramp characteristics elicits good-to-excellent inter-observer reliability. The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. SIGNIFICANCE This study provides evidence for a reliable method for inducing repeatable muscle cramps in abductor hallucis.",2020,"The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. ","['abductor hallucis', 'APPROACH\n\n\nFive (age 33.8 ± 5.7 y, 60% male) and ten (age 47.4 ± 11.7 y, 60% male']",['Electrical stimulation'],['muscle cramps'],"[{'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517535', 'cui_str': '11.7'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0026821', 'cui_str': 'Cramp'}]",,0.0496055,"The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. ","[{'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Akerman', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine, University of Otago, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'John B W', 'Initials': 'JBW', 'LastName': 'Schollum', 'Affiliation': ''}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Putt', 'Affiliation': ''}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': ''}]",Physiological measurement,['10.1088/1361-6579/ab8855'] 398,31942669,A randomised controlled study of high intensity exercise as a dishabituating stimulus to improve hypoglycaemia awareness in people with type 1 diabetes: a proof-of-concept study.,"AIMS/HYPOTHESIS Approximately 25% of people with type 1 diabetes have suppressed counterregulatory hormonal and symptomatic responses to insulin-induced hypoglycaemia, which renders them at increased risk of severe, disabling hypoglycaemia. This is called impaired awareness of hypoglycaemia (IAH), the cause of which is unknown. We recently proposed that IAH develops through habituation, a form of adaptive memory to preceding hypoglycaemia. Consistent with this hypothesis, we demonstrated restoration of defective counterregulatory hormonal responses to hypoglycaemia (referred to as dishabituation) in a rodent model of IAH following introduction of a novel stress stimulus (high intensity training [HIT]). In this proof-of-concept study we sought to further test this hypothesis by examining whether a single episode of HIT would amplify counterregulatory responses to subsequent hypoglycaemia in people with type 1 diabetes who had IAH (assessed by Gold score ≥4, modified Clarke score ≥4 or Dose Adjustment For Normal Eating (DAFNE) hypoglycaemia awareness rating 2 or 3). The primary outcome was the difference in adrenaline response to hypoglycaemia following both a single episode of HIT and rest. METHODS In this randomised, crossover study 12 participants aged between 18 and 55 years with type 1 diabetes for ≥5 years and an HbA 1c  <75 mmol/mol (9%) were recruited. Individuals were randomised using computer generated block randomisation to start with one episode of HIT (4 × 30 s cycle sprints [2 min recovery] at 150% of maximum wattage achieved during [Formula: see text] assessment) or rest (control). The following day they underwent a 90 min hyperinsulinaemic-hypoglycaemic clamp study at 2.5 mmol/l with measurement of hormonal counterregulatory response, symptom scores and cognitive testing (four-choice reaction time and digit symbol substitution test). Each intervention and subsequent clamp study was separated by at least 2 weeks. The participants and investigators were not blinded to the intervention or measurements during the study. The investigators were blinded to the primary outcome and blood analysis results. RESULTS All participants (six male and six female, age 19-54 years, median [IQR] duration of type 1 diabetes 24.5 [17.3-29.0] years, mean [SEM] HbA 1c 56 [3.67] mmol/mol; 7.3% [0.34%]) completed the study (both interventions and two clamps). In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day. CONCLUSIONS/INTERPRETATION These findings are consistent with the hypothesis that IAH develops in people with type 1 diabetes as a habituated response and that introduction of a novel stressor can restore, at least partially, the adapted counterregulatory hormonal, symptomatic and cognitive responses to hypoglycaemia. TRIAL REGISTRATION ISRCTN15236211.",2020,"In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day. ","['30', 'Approximately 25% of people with type', 'people with type', '12 participants aged between 18 and 55\xa0years with type 1 diabetes for ≥5\xa0years and an HbA 1c \xa0<75\xa0mmol/mol (9%) were recruited', 'people with type 1 diabetes who had IAH', 'All participants (six male and six female, age 19-54\xa0years, median [IQR] duration of type 1 diabetes 24.5 [17.3-29.0] years, mean [SEM] HbA 1c 56 [3.67] mmol/mol; 7.3% [0.34%]) completed the study (both interventions and two clamps']",['high intensity exercise'],"['prolongation of four-choice reaction time', 'total symptom scores (Edinburgh Hypoglycaemia Symptom Scale', 'hypoglycaemia awareness', 'Gold score\u2009≥4, modified Clarke score\u2009≥4 or Dose Adjustment For Normal Eating (DAFNE) hypoglycaemia awareness rating 2 or 3', 'cycle sprints [2\xa0min recovery', 'adrenaline response to hypoglycaemia', 'adrenaline (epinephrine) response']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0222045'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",12.0,0.183153,"In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day. ","[{'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'Farrell', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'McNeilly', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fournier', 'Affiliation': 'Faculty of Science, School of Human Science, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Medical Sciences, Paediatrics, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Simona M', 'Initials': 'SM', 'LastName': 'Hapca', 'Affiliation': 'Computing Science and Mathematics, Faculty of Natural Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'West', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Science, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK. r.mccrimmon@dundee.ac.uk.'}]",Diabetologia,['10.1007/s00125-019-05076-5'] 399,32274541,[Treatment concepts for primary oligometastatic prostate cancer].,"BACKGROUND About 5% of prostate cancer patients have distant metastases at diagnosis. In these metastatic hormone-sensitive prostate cancers (mHSPC), systemic therapy is recommended, according to the guidelines. Moreover, metastasis-directed therapy (MDT) is discussed to prolong survival. OBJECTIVES The contemporary literature concerning local therapy and MDT in patients with mHSPC is summarized. METHODS Selective literature search. RESULTS In 2018, randomized controlled data on local therapy in mHSPC patients were published by the authors of the STAMPEDE study. Here, patients were randomized between standard of care (SOC) ± radiotherapy to the prostate (RT). Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed. Within a prespecified subgroup of patients with low metastatic burden. Similar results were observed in numerous retrospective studies analyzing radical prostatectomy; prospective randomized studies are pending. For MDT, there are no sufficient data in mHSPC patients yet. CONCLUSIONS In the current guidelines, systematic therapy is standard of care in mHSPC patients. In patients with low metastatic burden, a survival benefit was observed when adding percutaneous RT to the prostate. Retrospective studies also suggest a benefit when adding RP. However, whether MDT prolongs survival is still unknown.",2020,"Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed.","['patients with low metastatic burden', 'primary oligometastatic prostate cancer', 'patients with mHSPC', 'mHSPC patients']","['MDT', 'standard of care (SOC)\u202f±\u2009radiotherapy to the prostate (RT']","['survival benefit', '3‑year overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.121008,"Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Knipper', 'Affiliation': 'Martini-Klinik Prostatakarzinomzentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland. a.knipper@uke.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Graefen', 'Affiliation': 'Martini-Klinik Prostatakarzinomzentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hadaschik', 'Affiliation': 'Klinik und Poliklinik für Urologie, Kinderurologie und Uroonkologie, Universitätsklinikum Essen, Essen, Deutschland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wiegel', 'Affiliation': 'Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Ulm, Ulm, Deutschland.'}]",Der Urologe. Ausg. A,['10.1007/s00120-020-01186-w'] 400,32268328,Effect of Lifestyle Interventions in Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children.,"INTRODUCTION Maternal obesity and excessive gestational weight gain are related to adverse outcomes in women and children. Lifestyle interventions during pregnancy showed positive effects on decreasing weight gain during pregnancy, but effects on offspring's health and wellbeing are unclear. We aimed to assess the effect of lifestyle intervention programmes on offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures. METHODS Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who were randomly assigned to 3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group) and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2) were used as an additional control group in this analysis. When the children were between 3 and 7 years old, anthropometric and cardiovascular measurements were conducted and various questionnaires about offspring mental health, temperament and eating habits were filled out. RESULTS Children of mothers who received a brochure-based lifestyle intervention programme showed significantly less surgency/extraversion compared to children of mothers who received routine antenatal care (contrast estimate = -0.36, SE = 0.15, p = 0.02, 95% CI [-6.66, -0.06]) and prenatal lifestyle intervention sessions (contrast estimate = -0.46, SE = 0.14, p < 0.01, 95% CI [-0.74, -0.18]) after adjusting for child's age, sex, offspring birth weight and mother's educational level. The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics. Children of mothers with a normal BMI showed less emotional problems (F(1, 156) = 5.42, p = 0.02) and internalizing (F(1, 156) = 3.04, p = 0.08) and externalizing problems (F(1, 156) = 6.10, p = 0.02) when compared to children of mothers in the obese group. DISCUSSION/CONCLUSION The results suggest that a brochure-based lifestyle intervention programme can affect the offspring temperament. Future follow-up studies need to investigate how these temperament-related effects may influence obesity development later in life.",2020,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","['and 77 offspring of pregnant women with a normal BMI (between 18.5 and 24.9 kg/m2', 'Ninety-six offspring of pregnant women with a body mass index (BMI) ≥29 kg/m2 who', 'Children of mothers with a normal BMI', 'Obese Pregnant Women on the Neurocognitive Development and Anthropometrics of Preschool Children', 'women and children']","['Lifestyle Interventions', 'brochure-based lifestyle intervention programme', 'lifestyle intervention programmes', '3 intervention groups during pregnancy (routine antenatal care, a brochure group or a prenatal session group']","['prenatal lifestyle intervention sessions', 'offspring mental health, eating habits and anthropometric and cardiovascular characteristics', 'offspring mental health, temperament, eating habits and anthropometric and cardiovascular measures', 'surgency/extraversion', 'externalizing problems', 'emotional problems', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.064488,"The lifestyle intervention could not be associated with any significant differences in offspring mental health, eating habits and anthropometric and cardiovascular characteristics.","[{'ForeName': 'Marijke Anne Katrien Alberta', 'Initials': 'MAKA', 'LastName': 'Braeken', 'Affiliation': 'Research Unit Resilient People, Faculty of Health and Social Work, University Colleges Leuven-Limburg, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium, annick.bogaerts@kuleuven.be.'}]",Obesity facts,['10.1159/000506690'] 401,26142345,"Genetic variation (CHRNA5), medication (combination nicotine replacement therapy vs. varenicline), and smoking cessation.","OBJECTIVE Recent evidence suggests that the efficacy of smoking cessation pharmacotherapy can vary across patients based on their genotypes. This study tests whether the coding variant rs16969968 in the CHRNA5 nicotinic receptor gene predicts the effects of combination nicotine replacement therapy (cNRT) and varenicline on treatment outcomes. METHOD In two randomized smoking cessation trials comparing cNRT vs. placebo, and varenicline vs. placebo, we used logistic regression to model associations between CHRNA5 rs16969968 and abstinence at end of treatment. RESULTS For abstinence at end of treatment, there was an interaction between cNRT and rs16969968 (X(2)=8.15, df=2, omnibus-p=0.017 for the interaction); individuals with the high-risk AA genotype were more likely to benefit from cNRT. In contrast, varenicline increased abstinence, but its effect did not vary with CHRNA5. However, the genetic effects differed between the placebo control groups across two trials (wald=3.94, df=1, p=0.047), this non-replication can alter the interpretation of pharmacogenetic findings. CONCLUSIONS Results from two complementary smoking cessation trials demonstrate inconsistent genetic results in the placebo arms. This evidence highlights the need to compare the most effective pharmacotherapies with the same placebo control to establish pharmacogenetic evidence to aid decisions on medication choice for patients trying to quit smoking.",2015,"However, the genetic effects differed between the placebo control groups across two trials (wald=3.94, df=1, p=0.047), this non-replication can alter the interpretation of pharmacogenetic findings. ",[],"['Genetic variation (CHRNA5), medication (combination nicotine replacement therapy vs. varenicline', 'nicotine replacement therapy (cNRT) and varenicline', 'varenicline', 'cNRT vs. placebo, and varenicline vs. placebo']",['genetic effects'],[],"[{'cui': 'C0042333', 'cui_str': 'Genetic Diversity'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",2.0,0.296887,"However, the genetic effects differed between the placebo control groups across two trials (wald=3.94, df=1, p=0.047), this non-replication can alter the interpretation of pharmacogenetic findings. ","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, 63110, United States; The Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, 63110, United States. Electronic address: chenli@psychiatry.wustl.edu.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin, School of Medicine and Public Health, Madison, WI, 53711, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jorenby', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin, School of Medicine and Public Health, Madison, WI, 53711, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin, School of Medicine and Public Health, Madison, WI, 53711, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO, 63110, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'Division of Health, Social and Economic Research, Research Triangle Institute International, Research Triangle Park, NC, 27709, United States.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Breslau', 'Affiliation': 'Department of Epidemiology, Michigan State University, East Lansing, MI, 48824, United States.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, 55455, United States.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, 63110, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, 63110, United States; The Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, 63110, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2015.06.022'] 402,31515154,"Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial.","BACKGROUND Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostate cancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel would improve the outcomes of men with metastatic castration-resistant prostate cancer. METHODS We did a phase 1-2, open label, randomised study at two centres in men with progressive metastatic castration-resistant prostate cancer. In phase 1, patients received intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin area under the curve (AUC) 3-4 mg/mL per min every 21 days. The maximum tolerated dose was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity. In phase 2, patients were randomly assigned (1:1) centrally by a computerised algorithm to intravenous cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min. All patients received growth factor support and oral prednisone 10 mg daily. The primary endpoints were the maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival in phase 2. This trial is registered at ClinicalTrials.gov, number NCT01505868. FINDINGS Between Aug 17, 2012, and May 11, 2015, nine patients completed phase 1 as planned, and 160 were randomly assigned to cabazitaxel (n=79) or cabazitaxel plus carboplatin (n=81) in phase 2. During phase I, grade 3 adverse events were anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events occurred. No dose-limiting toxicities were observed, therefore, a maximum tolerated dose of cabazitaxel of 25 mg/m 2 and carboplatin of AUC 4 mg/mL per min was selected for phase 2. At a median follow-up of 31·0 months (IQR 20·5-37·1), the combination improved the median progression-free survival from 4·5 months (95% CI 3·5-5·7) to 7·3 months (95% CI 5·5-8·2; hazard ratio 0·69, 95% CI 0·50-0·95, p=0·018). In the phase 2 study, the most common grade 3-5 adverse events were fatigue (7 [9%] of 79 in the cabazitaxel group vs 16 [20%] of 81 in the combination group), anaemia (3 [4%] vs 19 [23%]), neutropenia (3 [4%] vs 13 [16%]), and thrombocytopenia (1 [1%] vs 11 [14%]). There were no treatment-related deaths. INTERPRETATION Carboplatin added to cabazitaxel showed improved clinical efficacy compared with cabazitaxel alone for men with metastatic castration-resistant prostate cancer. Although adverse events were more common with the combination, the treatment was safe and generally well tolerated. Our data suggest that taxane-platinum combinations have a clinically beneficial role in advanced prostate cancer and a randomised phase 3 study is planned. FUNDING Sanofi Genzyme, University of Texas MD Anderson Cancer Center Prostate Cancer Moon Shot Program, and Solon Scott III Prostate Cancer Research Fund.",2019,"There were no treatment-related deaths. ","['men with metastatic castration-resistant prostate cancer', 'Between Aug 17, 2012, and May 11, 2015', 'men with progressive metastatic castration-resistant prostate cancer', 'men with metastatic castration-resistant prostate cancers']","['Taxane-platinum combinations', 'Carboplatin', 'Cabazitaxel plus carboplatin', 'cabazitaxel', 'cabazitaxel plus carboplatin', 'taxane-platinum combinations', 'intravenous cabazitaxel 20-25 mg/m 2 and intravenous carboplatin', 'carboplatin to cabazitaxel', 'cabazitaxel alone', 'cabazitaxel 25 mg/m 2 with or without intravenous carboplatin AUC 4 mg/mL per min', 'growth factor support and oral prednisone']","['clinical efficacy', 'safe and generally well tolerated', 'thrombocytopenia', 'anaemia', 'anaemia (n=2), fatigue (n=1), thrombocytopenia (n=1), hypomagnesaemia (n=1), diarrhoea (n=1), hypokalaemia (n=1), anorexia (n=1), and dehydration (n=1), and no grade 4 adverse events', 'neutropenia', 'median progression-free survival', 'maximum tolerated dose of the combination in phase 1 and investigator-assessed progression-free survival', 'maximum tolerated dose']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",,0.212863,"There were no treatment-related deaths. ","[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elisabeth I', 'Initials': 'EI', 'LastName': 'Heath', 'Affiliation': 'Department of Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Amado', 'Initials': 'A', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Ramesh', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Sei', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Li-Ning-Tapia', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shi-Ming', 'Initials': 'SM', 'LastName': 'Tu', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sumit K', 'Initials': 'SK', 'LastName': 'Subudhi', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Thompson', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Troncoso', 'Affiliation': 'Department of Anatomical Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Navin', 'Affiliation': 'Department of Genetics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Aparicio', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: aaparicio@mdanderson.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30408-5'] 403,32008809,"Feasibility and acceptability of active for life with COPD, an intervention to increase light physical activity in people with COPD.","BACKGROUND People with chronic obstructive pulmonary disease (COPD) are very sedentary; increasing light physical activity (LPA) may help to promote long-term maintenance of physical activity. OBJECTIVES We evaluated feasibility and acceptability of Active for Life with COPD, a self-efficacy-enhancing intervention designed to increase LPA. METHODS The 10-week intervention included walking, functional circuit training, and behavioral and educational strategies. Measures included attrition, adherence, objectively measured physical activity, and qualitative interviews. RESULTS Thirty-six subjects enrolled in the study; 26 completed the intervention and 19 completed the two-month follow-up. Subjects reported the intervention was enjoyable and beneficial, but disliked the activity log and buddy system. Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 h (P > 0.05); they retained a gain of 21 (SD = 88) min/24 h at the two-month follow-up (P > 0.05). CONCLUSIONS The Active for Life with COPD intervention is feasible, acceptable, and may support long term maintenance of physical activity.",2020,Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 ,"['Thirty-six subjects enrolled in the study; 26 completed the intervention and 19 completed the two-month follow-up', '88) min/24', 'People with chronic obstructive pulmonary disease (COPD', 'people with COPD']","['walking, functional circuit training, and behavioral and educational strategies', 'COPD intervention']","['light physical activity', 'attrition, adherence, objectively measured physical activity, and qualitative interviews', 'mean time spent standing/stepping']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",36.0,0.0437589,Subjects increased mean time spent standing/stepping by 36 (SD = 82) min/24 ,"[{'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Larson', 'Affiliation': 'University of Michigan School of Nursing, 400 North Ingalls Building, Ann Arbor, MI 48109-5482, United States. Electronic address: janetlar@umich.edu.'}, {'ForeName': 'Katelyn E', 'Initials': 'KE', 'LastName': 'Webster', 'Affiliation': 'University of Michigan School of Nursing, 400 North Ingalls Building, Ann Arbor, MI 48109-5482, United States.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.01.002'] 404,31665476,High water vs. ad libitum water intake for autosomal dominant polycystic kidney disease: a randomized controlled feasibility trial.,"BACKGROUND Vasopressin stimulates cyst growth in autosomal dominant polycystic kidney disease (ADPKD) and is a key therapeutic target. Evaluation of high water intake as an alternative to pharmacological vasopressin blockade is supported by patients. However feasibility, safety and adherence-promoting strategies required to deliver this remain unknown. AIMS Assess the feasibility of a definitive randomized high water intake trial in ADPKD. METHODS In this prospective open-label randomized trial, adult ADPKD patients with eGFR ≥ 20 ml/min/1.73 m2 were randomized to prescribed high water (HW) intake targeting urine osmolality (UOsm) ≤270 mOsm/kg, or ad libitum (AW) intake (UOsm >300 mOsm/kg). Self-management strategies including home-monitoring of urine-specific gravity (USG) were employed to promote adherence. RESULTS We enrolled 42 participants, baseline median eGFR (HW 68.4 [interquartile range (IQR) 35.9-107.2] vs. AW 75.8 [IQR 59.0-111.0 ml/min/1.73 m2, P = 0.22) and UOsm (HW 353 [IQR 190-438] vs. AW 350 [IQR 240-452] mOsm/kg, P = 0.71) were similar between groups. After 8 weeks, 67% in the HW vs. 24% in AW group achieved UOsm ≤270 mOsm/kg, P = 0.001. HW group achieved lower UOsm (194 [IQR 190-438] vs. 379 [IQR 235-503] mOsm/kg, P = 0.01) and higher urine volumes (3155 [IQR 2270-4295] vs. 1920 [IQR 1670-2960] ml/day, P = 0.02). Two cases of hyponatraemia occurred in HW group. No acute GFR effects were detected. In total 79% (519/672) of USG were submitted and 90% (468/519) were within target. Overall, 17% withdrew during the study. CONCLUSION DRINK demonstrated successful recruitment and adherence leading to separation between treatment arms in primary outcomes. These findings suggest a definitive trial assessing the impact of high water on kidney disease progression in ADPKD is feasible.",2020,"HW group achieved lower UOsm (194 [IQR 190-438] v 379 [IQR 235-503] mOsm/kg, p = 0.01) and higher urine volumes (3155 [IQR2270-4295] vs 1920 [IQR1670-2960] mls/day, p = 0.02).","['adult ADPKD patients with eGFR≥20ml/min/1.73m2', 'home-monitoring of urine specific gravity (USG', 'Autosomal Dominant Polycystic Kidney Disease (ADPKD', 'Autosomal Dominant Polycystic Kidney Disease']","['high water intake (HW) targeting urine osmolality (UOsm) ≤270mOsm/kg, or ad libitum (AW) intake', 'Vasopressin', 'High Water versus Ad libitum Water Intake']","['higher urine volumes', 'acute GFR effects', 'baseline median eGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine (procedure)'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",42.0,0.1896,"HW group achieved lower UOsm (194 [IQR 190-438] v 379 [IQR 235-503] mOsm/kg, p = 0.01) and higher urine volumes (3155 [IQR2270-4295] vs 1920 [IQR1670-2960] mls/day, p = 0.02).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'El-Damanawi', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'PKD Charity, 91 Royal College, London.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Cowley', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pavey', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Sandford', 'Affiliation': 'Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Karet Frankl', 'Affiliation': 'Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Hiemstra', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}]",QJM : monthly journal of the Association of Physicians,['10.1093/qjmed/hcz278'] 405,32267727,The Effect of Physical Activity on Human Milk Macronutrient Content and Its Volume.,"Objective: There are multiple health benefits associated with both breastfeeding and practicing physical activity (PA). Therefore, it is likely that many women might want to engage in both. We designed the current randomized clinical trial to examine the effect of moderate- to high-intensity PA on human milk (HM) volume and macronutrient contents. Methods and Study Design: In this prospective, randomized, crossover clinical trial, we recruited 31 healthy mothers who had been exclusively breastfeeding their infants. Mothers expressed HM twice each day on 2 consecutive days-a day with PA (1-hour before and 1-hour after PA) and a control day without PA (at the exact same hours of the day). The order of days (with/without PA) was determined randomly. Macronutrients and energy contents of HM were analyzed using the Human Milk Analyzer (Miris AB, Uppsala, Sweden). PA was graded according to the Borg Rating of Perceived Exertion scale (RPE scale). Results: A total 124 HM samples from 31 mothers were analyzed. Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content. Milk volume remained unaffected by PA as well. Conclusions: Maternal PA does not affect HM volume or its macronutrient contents. Lactating mothers can be reassured regarding their breast milk volume and composition while practicing PA of moderate to high intensity.",2020,"Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content.","['A total 124 HM samples from 31 mothers were analyzed', 'Lactating mothers', '31 healthy mothers who had been exclusively breastfeeding their infants']","['moderate- to high-intensity PA', 'Physical Activity']","['Milk volume', 'human milk (HM) volume and macronutrient contents', 'Borg Rating of Perceived Exertion scale (RPE scale', 'Human Milk Macronutrient Content and Its Volume']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0026140', 'cui_str': 'Breast milk'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",31.0,0.0249137,"Moderate- to high-intensity PA affected neither macronutrients (fat, carbohydrates, protein) nor energy content.","[{'ForeName': 'Moria', 'Initials': 'M', 'LastName': ""Be'er"", 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Mandel', 'Affiliation': ""Department of Neonatology, Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Yelak', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Dana Lihi', 'Initials': 'DL', 'LastName': 'Gal', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': ""Department of Neonatology, Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Lubetzky', 'Affiliation': ""Department of Pediatrics and Dana Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0292'] 406,30565779,Changing predictors of statin initiation in US women over two decades.,"PURPOSE To describe changing roles of predictors of statin initiation before and after incident coronary heart disease, and before and after publication of National Cholesterol Education Program Adult Treatment Panel-III (ATP-III) guidelines in a cohort of US women. METHODS We identified 34 382 women enrolled into the Women's Health Study from 1993 to 1995 and followed up until 2012. Proportions of previous nonusers initiating statins were described over time. We used multivariable linear regression models to estimate adjusted initiation proportion differences (IPDs) for initiation overall, separately before and after incident coronary heart disease, and separately for ATP-II and ATP-III time periods. RESULTS Key predictors of initiation overall were self-reported total cholesterol, and previous incident coronary heart disease, cerebrovascular disease, and diabetes. Adjusted IPDs (percentage) for total cholesterol > 240 vs <200 mg/dL were 7.5 (95% confidence interval [CI], 7.0-8.0) and 9.3 (95% CI, 8.7-9.9) during ATP-II and ATP-III time periods, respectively. Adjusted IPDs in women with diabetes were 7.0 (95% CI, 6.3-7.8) and 11.9 (95% CI, 6.7-17.0) for primary and secondary prevention, respectively, and 3.1 (95% CI, 2.1-4.0) and 9.2 (95% CI 8.2-10.2) for before and after ATP-III, respectively. CONCLUSIONS Secular trends reflected evolution toward risk factor-based treatment indications for statin initiation with increased initiation among diabetics and women with normal and borderline cholesterol. The role of serum cholesterol changed over time, though the character was scale (multiplicative vs additive) dependent. In pharmacoepidemiologic studies of statins, strength of confounding by important variables sometimes unmeasured in claims data, such as cholesterol level, may be calendar time dependent.",2019,"Adjusted IPDs in women with diabetes were 7.0 (95% CI, 6.3-7.8) and 11.9 (95% CI, 6.7-17.0) for primary and secondary prevention, respectively, and 3.1 (95% CI, 2.1-4.0) and 9.2 (95% CI 8.2-10.2) for before and after ATP-III, respectively. ","['diabetics and women with normal and borderline cholesterol', ""34\xa0382 women enrolled into the Women's Health Study from 1993 to 1995 and followed up until 2012""]",[],"['Adjusted IPDs (percentage) for total cholesterol', 'serum cholesterol', 'Adjusted IPDs', 'total cholesterol, and previous incident coronary heart disease, cerebrovascular disease, and diabetes']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",34382.0,0.0581044,"Adjusted IPDs in women with diabetes were 7.0 (95% CI, 6.3-7.8) and 11.9 (95% CI, 6.7-17.0) for primary and secondary prevention, respectively, and 3.1 (95% CI, 2.1-4.0) and 9.2 (95% CI 8.2-10.2) for before and after ATP-III, respectively. ","[{'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Kinsey', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Stürmer', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Rothman', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4704'] 407,31838046,Dual transcriptomic and epigenomic study of reaction severity in peanut-allergic children.,"BACKGROUND Unexpected allergic reactions to peanut are the most common cause of fatal food-related anaphylaxis. Mechanisms underlying the variable severity of peanut-allergic reactions remain unclear. OBJECTIVES We sought to expand mechanistic understanding of reaction severity in peanut allergy. METHODS We performed an integrated transcriptomic and epigenomic study of peanut-allergic children as they reacted in vivo during double-blind, placebo-controlled peanut challenges. We integrated whole-blood transcriptome and CD4 + T-cell epigenome profiles to identify molecular signatures of reaction severity (ie, how severely a peanut-allergic child reacts when exposed to peanut). A threshold-weighted reaction severity score was calculated for each subject based on symptoms experienced during peanut challenge and the eliciting dose. Through linear mixed effects modeling, network construction, and causal mediation analysis, we identified genes, CpGs, and their interactions that mediate reaction severity. Findings were replicated in an independent cohort. RESULTS We identified 318 genes with changes in expression during the course of reaction associated with reaction severity, and 203 CpG sites with differential DNA methylation associated with reaction severity. After replicating these findings in an independent cohort, we constructed interaction networks with the identified peanut severity genes and CpGs. These analyses and leukocyte deconvolution highlighted neutrophil-mediated immunity. We identified NFKBIA and ARG1 as hubs in the networks and 3 groups of interacting key node CpGs and peanut severity genes encompassing immune response, chemotaxis, and regulation of macroautophagy. In addition, we found that gene expression of PHACTR1 and ZNF121 causally mediates the association between methylation at corresponding CpGs and reaction severity, suggesting that methylation may serve as an anchor upon which gene expression modulates reaction severity. CONCLUSIONS Our findings enhance current mechanistic understanding of the genetic and epigenetic architecture of reaction severity in peanut allergy.",2020,"We identified NFKBIA and ARG1 as hubs in the networks and three groups of interacting key node CpGs and peanut severity genes encompassing immune response, chemotaxis, and regulation of macroautophagy.",['peanut allergic children'],['placebo-controlled peanut challenges'],[],"[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}]",[],,0.0792526,"We identified NFKBIA and ARG1 as hubs in the networks and three groups of interacting key node CpGs and peanut severity genes encompassing immune response, chemotaxis, and regulation of macroautophagy.","[{'ForeName': 'Anh N', 'Initials': 'AN', 'LastName': 'Do', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Corey T', 'Initials': 'CT', 'LastName': 'Watson', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Biochemistry and Molecular Genetics, University of Louisville School of Medicine, Louisville, Ky.'}, {'ForeName': 'Ariella T', 'Initials': 'AT', 'LastName': 'Cohain', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Griffin', 'Affiliation': 'Department of Anesthesia, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Grishin', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wesley Burks', 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scurlock', 'Affiliation': ""Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Donald Y M', 'Initials': 'DYM', 'LastName': 'Leung', 'Affiliation': 'Department of Pediatrics, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sharp', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Schadt', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Supinda', 'Initials': 'S', 'LastName': 'Bunyavanich', 'Affiliation': 'Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY; Division of Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: supinda@post.harvard.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.040'] 408,31081899,Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.,"BACKGROUND Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to manage insomnia, the comparative effectiveness between acupuncture and Cognitive Behavioral Therapy for Insomnia (CBT-I) for this disorder is unknown. METHODS This randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific points on the body with needles. CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education. We measured insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment (8 weeks) with follow-up until 20 weeks. We used linear mixed-effects models for analyses. All statistical tests were two-sided. RESULTS The mean age was 61.5 years and 56.9% were women. CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks. Acupuncture was more effective for pain at the end of treatment; both groups had similar improvements in fatigue, mood, and quality of life and reduced prescription hypnotic medication use. CBT-I was more effective for those who were male (P < .001), white (P = .003), highly educated (P < .001), and had no pain at baseline (P < .001). CONCLUSIONS Although both treatments produced meaningful and durable improvements, CBT-I was more effective and should be the first line of therapy. The relative differences in the comparative effectiveness between the two interventions for specific groups should be confirmed in future adequately powered trials to guide more tailored interventions for insomnia.",2019,"CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks.","['The mean age was 61.5\u2009years and 56.9% were women', 'Cancer Survivors']","['Acupuncture', 'Acupuncture Versus Cognitive Behavioral Therapy', 'acupuncture', 'acupuncture and Cognitive Behavioral Therapy']","['no pain', 'insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment', 'CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education', 'insomnia severity', 'fatigue, mood, and quality of life and reduced prescription hypnotic medication use']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871436', 'cui_str': 'Stimulus control'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring (regime/therapy)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.134623,"CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks.","[{'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ''}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'DuHamel', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Frances K', 'Initials': 'FK', 'LastName': 'Barg', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gehrman', 'Affiliation': ''}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djz050'] 409,30760125,Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin.,"Objective: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. Methods: In this double-blind, multicenter, randomized, phase III study (VERTIS SU; NCT01999218), adults with T2DM and glycated hemoglobin (HbA1c) 7.0-9.0% on metformin ≥1500 mg/day received ertugliflozin 5 mg or 15 mg, or glimepiride. The primary efficacy time point was Week 52; double-blinded treatment continued until Week 104. Results: Baseline characteristics of randomized, treated patients ( n  = 1315) were similar across groups (mean age 58.2 years, HbA1c 7.8%); 76.4% completed the study; 61.6% completed on study medication. Mean glimepiride dose at 104 weeks was 3.5 mg/day. At Week 104, least squares mean change from baseline in HbA1c (95% confidence intervals) were -0.3% (-0.4, -0.2), -0.4% (-0.5, -0.3) and -0.4% (-0.5, -0.3) for ertugliflozin 5 mg, 15 mg, and glimepiride, respectively. Ertugliflozin provided sustained reductions in body weight and systolic blood pressure (SBP) over 104 weeks. The incidence of adverse events (AEs) and serious AEs was similar across groups. The incidence of symptomatic hypoglycemia was 3.8%, 6.4% and 22.1% in the ertugliflozin 5 mg, 15 mg, and glimepiride groups, respectively. Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively. The incidence of urinary tract infection and hypovolemia AEs was similar across groups. Conclusions: Ertugliflozin was well tolerated and provided clinically meaningful glycemic control and durable reductions in body weight and SBP over 104 weeks.",2019,"Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively.","['patients with type 2 diabetes mellitus inadequately controlled on', 'treated patients ( n \u2009=\u20091315) were similar across groups (mean age 58.2 years, HbA1c 7.8%); 76.4% completed the study; 61.6% completed on study medication', 'adults with T2DM and glycated hemoglobin', 'patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin']","['Ertugliflozin', 'metformin', 'glimepiride', 'ertugliflozin 5\u2009mg or 15\u2009mg, or glimepiride', 'Mean glimepiride', 'metformin ≥1500', 'ertugliflozin']","['urinary tract infection and hypovolemia AEs', 'safety and efficacy', 'body weight and SBP', 'HbA1c', 'body weight and systolic blood pressure (SBP', 'incidence of symptomatic hypoglycemia', 'Genital mycotic infections', 'incidence of adverse events (AEs) and serious AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1315.0,0.0755749,"Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively.","[{'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Hollander', 'Affiliation': 'a Baylor Endocrine Center , Dallas , TX , USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Wei Jiang', 'Affiliation': 'c MSD R&D (China) Co. Ltd , Beijing , China.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Golm', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'd Pfizer Inc. , Andover , MA , USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'e Pfizer Inc. , Groton , CT , USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Lauring', 'Affiliation': 'f formerly of Merck & Co. Inc. , Kenilworth , NJ , USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'b Merck & Co. Inc. , Kenilworth , NJ , USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1583450'] 410,31189985,"Theta band high definition transcranial alternating current stimulation, but not transcranial direct current stimulation, improves associative memory performance.","Associative memory (AM) deficits are common in neurodegenerative disease and novel therapies aimed at improving these faculties are needed. Theta band oscillations within AM networks have been shown to be important for successful memory encoding and modulating these rhythms represents a promising strategy for cognitive enhancement. Transcranial alternating current stimulation (TACS) has been hypothesized to entrain and increase power of endogenous brain rhythms. For this reason, we hypothesized that focal delivery of theta band electrical current, using high-definition TACS, would result in improved AM performance compared to sham stimulation or transcranial direct current stimulation (TDCS). In this pilot study, 60 healthy subjects were randomized to receive high definition TACS, high definition TDCS, or sham stimulation delivered to the right fusiform cortex during encoding of visual associations. Consistent with our hypothesis, improved AM performance was observed in the TACS group, while TDCS had no effect. However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes. Overall, this work informs strategies for improving associative memory and suggests alternating current is more effective than direct current stimulation in some contexts.",2019,"However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes.",['60 healthy subjects'],"['TDCS', 'transcranial direct current stimulation (TDCS', 'high definition TACS, high definition TDCS, or sham stimulation', 'Transcranial alternating current stimulation (TACS', 'TACS']","['associative memory performance', 'correct rejection', 'AM performance', 'Associative memory (AM) deficits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}]",60.0,0.164414,"However, TACS also resulted in improved correct rejection of never seen items, reduced false memory, and reduced forgetting, suggesting the effect may not be specific for AM processes.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Liu Shi', 'Initials': 'LS', 'LastName': 'Gan', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Tazrina', 'Initials': 'T', 'LastName': 'Alrazi', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Oury', 'Initials': 'O', 'LastName': 'Monchi', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada. oury.monchi@ucalgary.ca.'}]",Scientific reports,['10.1038/s41598-019-44680-8'] 411,31189978,"Randomized Evaluation of Anagliptin vs Sitagliptin On low-density lipoproteiN cholesterol in diabetes (REASON) Trial: A 52-week, open-label, randomized clinical trial.","Additional reductions in low-density lipoprotein-cholesterol (LDL-C) via antidiabetic therapies should be considered in statin-using patients with sub-optimal LDL-C levels. We compared the efficacy of anagliptin and sitagliptin, two antidiabetic therapies, in reducing LDL-C in type 2 diabetic patients. A randomized, open-label, parallel-group trial was conducted at 17 centres in Japan between April 2015 and January 2018. Adults (age ≥20 years) with type 2 diabetes, any atherosclerotic vascular lesions, and statin prescriptions were included. Anagliptin or sitagliptin were administered for 52 weeks. Primary and secondary endpoints were changes in LDL-C and haemoglobin A1C (HbA1c) levels, respectively. We assessed the superiority (primary endpoint) and non-inferiority (secondary endpoint) of anagliptin over sitagliptin. This study was registered at Clinicaltrials.gov (NCT02330406). Of 380 participants, 353 were eligible and randomized. Mean participant age was 68 years, and 61% were males. Baseline median LDL-C and HbA1c were 108 mg/dL and 6.9%, respectively. Changes in LDL-C were -3.7 mg/dL with anagliptin and +2.1 mg/dL with sitagliptin at 52 weeks, and the estimated treatment difference was a significant -4.5 mg/dL (P = 0.01 for superiority). Changes in HbA1c were +0.02% with anagliptin and +0.12% with sitagliptin (P < 0.0001 for non-inferiority). Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.",2019,"Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.","['17 centres in Japan between April 2015 and January 2018', 'type 2 diabetic patients', 'low-density lipoproteiN cholesterol in diabetes (REASON', 'Adults (age ≥20 years) with type 2 diabetes, any atherosclerotic vascular lesions, and statin prescriptions were included', 'Mean participant age was 68 years, and 61% were males', '380 participants, 353 were eligible and randomized']","['Anagliptin vs Sitagliptin', 'Anagliptin or sitagliptin', 'anagliptin and sitagliptin, two antidiabetic therapies']","['low-density lipoprotein-cholesterol (LDL-C', 'changes in LDL-C and haemoglobin A1C (HbA1c) levels', 'Baseline median LDL-C and HbA1c', 'LDL-C', 'Changes in HbA1c']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}]","[{'cui': 'C3272640', 'cui_str': 'Pyrazolo(1,5-a)pyrimidine-6-carboxamide, N-(2-((2-((2S)-2-cyano-1-pyrrolidinyl)-2-oxoethyl)amino)-2-methylpropyl)-2-methyl-'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",,0.230143,"Overall, anagliptin was superior to sitagliptin in lowering LDL-C without deteriorating HbA1c.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan. t-morimoto@umin.net.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic N-27, E-8, 1-15, Higashi, Sapporo, Hokkaido, 065-0027, Japan.'}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sakuma', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tokushige', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Natsuaki', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Asahi', 'Affiliation': 'Department of Cardiology, Naha City Hospital, 2-31-1 Furujima, Naha, Okinawa, 902-8511, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology and Metabolism, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, Fukuoka University, 7-45-1 Nanakuma, Jyonan, Fukuoka, 814-0180, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Arasaki', 'Affiliation': 'Department of Cardiology, Tomishiro Central Hospital, 25 Ueda, Tomigusuku, Okinawa, 901-0243, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, 849-8501, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of the Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan.'}]",Scientific reports,['10.1038/s41598-019-44885-x'] 412,32270208,Invited Response on: Mastopexy with Autologous Augmentation in Women After Massive Weight Loss-A Randomized Clinical Trial.,,2020,,['Women'],['Mastopexy with Autologous Augmentation'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0191918', 'cui_str': 'Fixation of pendulous breast'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.0942726,,"[{'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Ikander', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark. peder.ikander@gmail.com.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Sørensen', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørn B', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01697-z'] 413,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA. METHODS The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score). RESULTS 56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously. CONCLUSION XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2019,"CONCLUSION XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017'] 414,32267588,Impact of health warning labels communicating the risk of cancer on alcohol selection: an online experimental study.,"AIMS Evidence from tobacco research suggests that health warning labels (HWLs) depicting the adverse consequences of consumption change smoking behaviours, with image-and-text (also known as 'pictorial' or 'graphic') HWLs most effective. There is an absence of evidence concerning the potential impact of HWLs placed on alcohol products on selection of those products. This study aimed to obtain a preliminary assessment of the possible impact of (i) image-and-text, (ii) text-only, and (iii) image-only HWLs on selection of alcoholic versus non-alcoholic drinks. DESIGN A between-subjects randomised experiment with a 2 (image: present versus absent) × 2 (text: present versus absent) factorial design. SETTING The study was conducted on the online survey platform Qualtrics. PARTICIPANTS Participants (n = 6024) were adults over the age of 18 who consumed beer or wine regularly (i.e. at least once a week), recruited through a market research agency. INTERVENTIONS Participants were randomised to one of four groups varying in the HWL displayed on the packaging of alcoholic drinks: (i) image-and-text HWL; (ii) text-only HWL; (iii) image-only HWL; and (iv) no HWL. HWLs depicted bowel cancer, breast cancer and liver cancer, which were each displayed twice across six alcoholic drinks. Each group viewed six alcoholic and six non-alcoholic drinks and selected one drink that they would like to consume. MEASUREMENTS The primary outcome was the proportion of participants selecting an alcoholic versus a non-alcoholic drink. FINDINGS Alcoholic drink selection was lower for all HWL types compared with no HWL (image-and-text: 56%; image-only: 49%; text-only: 61%; no HWL: 77%), with selection lowest for HWLs that included an image. Image-and-text HWLs reduced the odds of selecting an alcoholic drink compared with text-only HWLs (OR = 0.80, 95% CI = 0.69, 0.92), but increased the odds of selecting an alcoholic drink compared with image-only HWLs (OR = 1.34, 95% CI = 1.16, 1.55). CONCLUSIONS Health warning labels communicating the increased risk of cancers associated with alcohol consumption reduced selection of alcoholic versus non-alcoholic drinks in a hypothetical choice task in an online setting; labels displaying images had the largest effect. Their impact in laboratory and real-world field settings using physical products awaits investigation.",2020,"Image-and-text HWLs reduced the odds of selecting an alcoholic drink compared with text-only HWLs (OR = 0.80, 95% CI = 0.69, 0.92), but increased the odds of selecting an alcoholic drink compared with image-only HWLs (OR = 1.34, 95% CI = 1.16, 1.55). ","['A between-subjects randomised experiment with a 2 (image: present vs absent', 'Participants (n=6024) were adults over the age of 18 who consumed beer or wine regularly (i.e., at least once a week), recruited through a market research agency', 'cancer on alcohol selection']","['image-only HWL', 'image-and-text (b) text-only and (c) image-only HWLs', 'six alcoholic and six non-alcoholic drinks and selected one drink that they would like to consume']","['bowel cancer, breast cancer and liver cancer', 'odds of selecting an alcoholic drink', 'proportion of participants selecting an alcoholic versus a non-alcoholic drink']","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0024825', 'cui_str': 'Market Research'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]",6024.0,0.163057,"Image-and-text HWLs reduced the odds of selecting an alcoholic drink compared with text-only HWLs (OR = 0.80, 95% CI = 0.69, 0.92), but increased the odds of selecting an alcoholic drink compared with image-only HWLs (OR = 1.34, 95% CI = 1.16, 1.55). ","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15072'] 415,31593271,Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.,"Importance Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective To evaluate whether a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers can improve outcomes. Design, Setting, and Participants Single-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions The intervention (n = 120) involved a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by nurses with special training on supporting patients with COPD using standardized tools. Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 62.3 (18.8) in the intervention group and 63.6 (17.4) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.45-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11). During the study period, there were 15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137). Conclusions and Relevance In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly greater COPD-related hospitalizations and emergency department visits, without improvement in quality of life. Further research is needed to determine reasons for this unanticipated finding. Trial Registration ClinicalTrials.gov Identifier: NCT02036294.",2019,"The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11).","['Participants\n\n\nSingle-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants', 'Participants were patients hospitalized due to COPD', 'Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations', '15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137', 'Hospitalized With Chronic Obstructive Pulmonary Disease', '240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study', 'patients hospitalized due to COPD', 'patients hospitalized due to COPD and their family caregivers']","['comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD', 'hospital-initiated program that combined transition and long-term self-management support', 'Usual care (n\u2009=\u2009120) included transition support', 'Hospital-Initiated Program']","['number of COPD-related acute care events (hospitalizations and emergency department visits', 'mean number of COPD-related acute care events', 'quality of life', 'SGRQ total score', ""participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ"", 'mean (SD) baseline SGRQ score']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",240.0,0.147679,"The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11).","[{'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Aboumatar', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Naqibuddin', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Suna', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Chaudhry', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jamia', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bone', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Ayse P', 'Initials': 'AP', 'LastName': 'Gurses', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Knowlton', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pronovost', 'Affiliation': 'Armstrong Institute for Patient Safety and Quality, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Putcha', 'Affiliation': 'Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rand', 'Affiliation': 'Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Roter', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Sylvester', 'Affiliation': 'Johns Hopkins Bayview Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Johns Hopkins Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hibbard', 'Affiliation': 'Health Policy Research Group, University of Oregon, Eugene.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.11982'] 416,32265255,"Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study.","OBJECTIVE To compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin used in pregnant women with diabetes. RESEARCH DESIGN AND METHODS A randomized study was conducted in diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes). All patients were randomly divided into two groups: IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR-IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR-NPH plan). Patients were enrolled during 12-28 gestation weeks and followed up until delivery. RESULTS Basal characteristics, such as age, enrollment gestational weeks, average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT) were similar between two groups. After 1 week of treatment, the FPG of IDet group were significantly lower than NPH group (p<0.05) and the time required to reach the targeted blood glucose level was significantly shorter (p<0.001). After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level. Maternal and neonatal outcomes were comparable between the two therapeutic approaches; however, the incidence of hypoglycemia in IDet group was remarkably lower than that of NPH group (p<0.05). The adverse drug reactions were rare and similar between the two groups. CONCLUSIONS For the treatment of gestational diabetes, both RRR-IDet plan and RRR-NPH plan were reported to control blood glucose effectively. Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes. Therefore, for pregnant women with gestational diabetes, who require insulin therapy, IDet would be an ideal basal insulin being worthy of promotion in clinical settings.",2020,"After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level.","['diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes', 'pregnant women with diabetes', 'pregnant women', 'diabetes during pregnancy', 'pregnant women with gestational diabetes']","['NPH', 'insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin', 'insulin detemir versus neutral protamine hagedorn insulin', 'IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR-IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR-NPH plan']","['adverse drug reactions', 'HbA1c level', 'number of insulin injections and the incidence of hypoglycemia', 'time required to reach the targeted blood glucose level', 'average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT', 'incidence of hypoglycemia', 'control blood glucose', 'Maternal and neonatal outcomes']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0537270', 'cui_str': 'insulin detemir'}, {'cui': 'C0021658', 'cui_str': 'insulin, isophane'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0307073', 'cui_str': 'Novolin R'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0281521,"After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Zhangya', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynecology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.""}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhengfeei', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': ""Department of Health and Environmental Sciences, Xi'an Jiaotong-Liverpool University, Suzhou, China.""}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China luoxiaoqin2012@mail.xjtu.edu.cn hanzhen@xjtufh.edu.cn.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ""Department of Obstetrics and Gynecology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China luoxiaoqin2012@mail.xjtu.edu.cn hanzhen@xjtufh.edu.cn.""}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001155'] 417,22648373,Interplay of genetic risk factors (CHRNA5-CHRNA3-CHRNB4) and cessation treatments in smoking cessation success.,"OBJECTIVE Smoking is highly intractable, and the genetic influences on cessation are unclear. Identifying the genetic factors affecting smoking cessation could elucidate the nature of tobacco dependence, enhance risk assessment, and support development of treatment algorithms. This study tested whether variants in the nicotinic receptor gene cluster CHRNA5-CHRNA3-CHRNB4 predict age at smoking cessation and relapse after an attempt to quit smoking. METHOD In a community-based, crosssectional study (N=5,216) and a randomized comparative effectiveness smoking cessation trial (N=1,073), the authors used Cox proportional hazard models and logistic regression to model the relationships of smoking cessation (self-reported quit age in the community study and point-prevalence abstinence at the end of treatment in the clinical trial) to three common haplotypes in the CHRNA5-CHRNA3-CHRNB4 region defined by rs16969968 and rs680244. RESULTS The genetic variants in the CHRNA5-CHRNA3-CHRNB4 region that predict nicotine dependence also predicted a later age at smoking cessation in the community sample. In the smoking cessation trial, haplotype predicted abstinence at end of treatment in individuals receiving placebo but not among individuals receiving active medication. Haplotype interacted with treatment in affecting cessation success. CONCLUSIONS Smokers with the high-risk haplotype were three times as likely to respond to pharmacologic cessation treatments as were smokers with the low-risk haplotype. The high-risk haplotype increased the risk of cessation failure, and this increased risk was ameliorated by cessation pharmacotherapy. By identifying a high-risk genetic group with heightened response to smoking cessation pharmacotherapy, this work may support the development of personalized cessation treatments.",2012,"The high-risk haplotype increased the risk of cessation failure, and this increased risk was ameliorated by cessation pharmacotherapy.",['Smokers with the high-risk haplotype'],['placebo'],['risk of cessation failure'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",5216.0,0.0249253,"The high-risk haplotype increased the risk of cessation failure, and this increased risk was ameliorated by cessation pharmacotherapy.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry and the Department of Genetics, Washington University School of Medicine, St. Louis, MO, USA. chenli@psychiatry.wustl.edu'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': ''}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Breslau', 'Affiliation': ''}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'Kimberly F', 'Initials': 'KF', 'LastName': 'Doheny', 'Affiliation': ''}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gogarten', 'Affiliation': ''}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': ''}, {'ForeName': 'Jen C', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Goate', 'Affiliation': ''}, {'ForeName': 'Laura Jean', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': ''}]",The American journal of psychiatry,['10.1176/appi.ajp.2012.11101545'] 418,32265143,"Optical enhancement imaging versus acetic acid for detecting gastric intestinal metaplasia: A randomized, comparative trial.","BACKGROUND AND AIMS The diagnosis of gastric intestinal metaplasia (GIM) is still challenging. Optical Enhancement technology (OE) may improve the detection of GIM. We compared detection of GIM with OE, acetic acid and the Sydney biopsy protocol in a surveillance population. METHODS Consecutive patients with atrophic gastritis or known GIM were prospectively included. The stomach was examined with high definition whitelight endoscopy, followed by OE or acetic acid with targeted biopsies (1:1 randomisation). Subsequently, five random biopsies were taken according to the updated Sydney system. RESULTS A total of 154 patients were randomized. Higher proportions of patients with GIM were detected by OE and acetic acid versus random biopsy (60.5% vs 35.5%, 67.1% vs 31.5%, respectively; P < 0.0001 for both comparisons). The combined use of targeted biopsies and random biopsies provides high diagnostic yields for GIM (78.9% in OE group and 83.6% in acetic acid group). In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively). CONCLUSIONS OE and acetic acid showed comparable results diagnosing GIM in the study. Targeted biopsies plus random biopsies should be used complementary in high risk populations.",2020,"In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively). ","['Consecutive patients with atrophic gastritis or known GIM were prospectively included', '154 patients were randomized', 'gastric intestinal metaplasia']","['OE and acetic acid', 'Optical enhancement imaging versus acetic acid', 'GIM with OE, acetic acid and the Sydney biopsy protocol', 'Optical Enhancement technology (OE']",['proportion of extensive GIM'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0267187', 'cui_str': 'Intestinal metaplasia of gastric mucosa'}]","[{'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0969683', 'cui_str': 'Enhancement Technologies'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}]",154.0,0.122132,"In addition, the proportion of extensive GIM was significantly increased when image enhanced endoscopy was used instead of white light endoscopy (P = 0.029, P = 0.048, respectively). ","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ji', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Ming-Ming', 'Initials': 'MM', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Yue-Yue', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Qilu Hospital, Shandong University, Jinan, China.'}, {'ForeName': 'Yan-Qing', 'Initials': 'YQ', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, China. Electronic address: liyanqing@sdu.edu.cn.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.02.010'] 419,30549127,Effects of antiepileptic drugs on cortical excitability in humans: A TMS-EMG and TMS-EEG study.,"Brain responses to transcranial magnetic stimulation (TMS) recorded by electroencephalography (EEG) are emergent noninvasive markers of neuronal excitability and effective connectivity in humans. However, the underlying physiology of these TMS-evoked EEG potentials (TEPs) is still heavily underexplored, impeding a broad application of TEPs to study pathology in neuropsychiatric disorders. Here we tested the effects of a single oral dose of three antiepileptic drugs with specific modes of action (carbamazepine, a voltage-gated sodium channel (VGSC) blocker; brivaracetam, a ligand to the presynaptic vesicle protein VSA2; tiagabine, a gamma-aminobutyric acid (GABA) reuptake inhibitor) on TEP amplitudes in 15 healthy adults in a double-blinded randomized placebo-controlled crossover design. We found that carbamazepine decreased the P25 and P180 TEP components, and brivaracetam the N100 amplitude in the nonstimulated hemisphere, while tiagabine had no effect. Findings corroborate the view that the P25 represents axonal excitability of the corticospinal system, the N100 in the nonstimulated hemisphere propagated activity suppressed by inhibition of presynaptic neurotransmitter release, and the P180 late activity particularly sensitive to VGSC blockade. Pharmaco-physiological characterization of TEPs will facilitate utilization of TMS-EEG in neuropsychiatric disorders with altered excitability and/or network connectivity.",2019,"Findings corroborate the view that the P25 represents axonal excitability of the corticospinal system, the N100 in the nonstimulated hemisphere propagated activity suppressed by inhibition of presynaptic neurotransmitter release, and the P180 late activity particularly sensitive to VGSC blockade.","['humans', '15 healthy adults']","['antiepileptic drugs', 'placebo', 'action (carbamazepine, a voltage-gated sodium channel (VGSC) blocker; brivaracetam', 'gamma-aminobutyric acid (GABA) reuptake inhibitor', 'transcranial magnetic stimulation (TMS) recorded by electroencephalography (EEG', 'carbamazepine']",['cortical excitability'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C3494198', 'cui_str': 'Voltage-Gated Sodium Channel Inhibitors'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",15.0,0.0844827,"Findings corroborate the view that the P25 represents axonal excitability of the corticospinal system, the N100 in the nonstimulated hemisphere propagated activity suppressed by inhibition of presynaptic neurotransmitter release, and the P180 late activity particularly sensitive to VGSC blockade.","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Darmani', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Til O', 'Initials': 'TO', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Zipser', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Müller-Dahlhaus', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.'}]",Human brain mapping,['10.1002/hbm.24448'] 420,24033696,Pharmacotherapy effects on smoking cessation vary with nicotine metabolism gene (CYP2A6).,"BACKGROUND AND AIMS Evidence suggests that both the nicotinic receptor α5 subunit (CHRNA5) and Cytochrome P450 2A6 (CYP2A6) genotypes influence smoking cessation success and response to pharmacotherapy. We examine the effect of CYP2A6 genotype on smoking cessation success and response to cessation pharmacotherapy, and combine these effects with those of CHRNA5 genotypes. DESIGN Placebo-controlled randomized smoking cessation trial. SETTING Ambulatory care facility in Wisconsin, USA. PARTICIPANTS Smokers (n = 709) of European ancestry were randomized to placebo, bupropion, nicotine replacement therapy or combined bupropion and nicotine replacement therapy. MEASUREMENTS Survival analysis was used to model time to relapse using nicotine metabolism derived from CYP2A6 genotype-based estimates. Slow metabolism is defined as the lowest quartile of estimated metabolic function. FINDINGS CYP2A6-defined nicotine metabolic function moderated the effect of smoking cessation pharmacotherapy on smoking relapse over 90 days [hazard ratio (HR) = 2.81, 95% confidence interval (CI) = 1.32-5.99, P = 0.0075], with pharmacotherapy significantly slowing relapse in fast (HR = 0.39, 95% CI = 0.28-0.55, P = 1.97 × 10(-8)), but not slow metabolizers (HR = 1.09, 95% CI = 0.55-2.17, P = 0.80). Further, only the effect of nicotine replacement, and not bupropion, varies with CYP2A6-defined metabolic function. The effect of nicotine replacement on continuous abstinence is moderated by the combined genetic risks from CYP2A6 and CHRNA5 (Wald = 7.44, d.f. = 1, P = 0.0064). CONCLUSIONS Nicotine replacement therapy is effective among individuals with fast, but not slow, CYP2A6-defined nicotine metabolism. The effect of bupropion on relapse likelihood is unlikely to be affected by nicotine metabolism as estimated from CYP2A6 genotype. The variation in treatment responses among smokers with genes may guide future personalized smoking cessation interventions.",2014,The effect of bupropion on relapse likelihood is unlikely to be affected by nicotine metabolism as estimated from CYP2A6 genotype.,"['Smokers (n\u2009=\u2009709) of European ancestry', 'Ambulatory care facility in Wisconsin, USA']","['bupropion', 'nicotine replacement', 'placebo, bupropion, nicotine replacement therapy or combined bupropion and nicotine replacement therapy', 'Placebo', 'CYP2A6 genotype', 'Nicotine replacement therapy']","['slowing relapse', 'smoking relapse']","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1828472', 'cui_str': 'Cytochrome P-450 CYP-2A3'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",,0.117613,The effect of bupropion on relapse likelihood is unlikely to be affected by nicotine metabolism as estimated from CYP2A6 genotype.,"[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'A Joseph', 'Initials': 'AJ', 'LastName': 'Bloom', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI53711.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI53711.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI53711.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN 55455.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goate', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110.'}]","Addiction (Abingdon, England)",['10.1111/add.12353'] 421,25072098,Beyond cigarettes per day. A genome-wide association study of the biomarker carbon monoxide.,"RATIONALE The CHRNA5-CHRNA3-CHRNB4 locus is associated with self-reported smoking behavior and also harbors the strongest genetic associations with chronic obstructive pulmonary disease (COPD) and lung cancer. Because the associations with lung disease remain after adjustment for self-reported smoking behaviors, it has been asserted that CHRNA5-CHRNA3-CHRNB4 variants increase COPD and lung cancer susceptibility independently of their effects on smoking. OBJECTIVES To compare the genetic associations of exhaled carbon monoxide (CO), a biomarker of current cigarette exposure, with self-reported smoking behaviors. METHODS A total of 1,521 European American and 247 African American current smokers recruited into smoking cessation studies were assessed for CO at intake before smoking cessation. DNA samples were genotyped using the Illumina Omni2.5 microarray. Genetic associations with CO and smoking behaviors (cigarettes smoked per day, Fagerstrom test for nicotine dependence) were studied. MEASUREMENTS AND MAIN RESULTS Variants in the CHRNA5-CHRNA3-CHRNB4 locus, including rs16969968, a nonsynonymous variant in CHRNA5, are genomewide association study-significantly associated with CO (β = 2.66; 95% confidence interval [CI], 1.74-3.58; P = 1.65 × 10(-8)), and this association remains strong after adjusting for smoking behavior (β = 2.18; 95% CI, 1.32-3.04; P = 7.47 × 10(-7)). The correlation between CO and cigarettes per day is statistically significantly lower (z = 3.43; P = 6.07 × 10(-4)) in African Americans (r = 0.14; 95% CI, 0.02-0.26; P = 0.003) than in European-Americans (r = 0.36; 95% CI, 0.31-0.40; P = 0.0001). CONCLUSIONS Exhaled CO, a biomarker that is simple to measure, captures aspects of cigarette smoke exposure in current smokers beyond the number of cigarettes smoked per day. Behavioral measures of smoking are therefore insufficient indices of cigarette smoke exposure, suggesting that genetic associations with COPD or lung cancer that persist after adjusting for self-reported smoking behavior may still reflect genetic effects on smoking exposure.",2014,"The correlation between CO and cigarettes per day is statistically significantly lower (z = 3.43; P = 6.07 × 10(-4)) in African Americans (r = 0.14; 95% CI, 0.02-0.26; P = 0.003) than in European-Americans (r = 0.36; 95% CI, 0.31-0.40; P = 0.0001). ","['1,521 European American and 247 African American current smokers recruited into smoking cessation studies']",['exhaled carbon monoxide (CO'],[],"[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3241966'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",[],1521.0,0.0209155,"The correlation between CO and cigarettes per day is statistically significantly lower (z = 3.43; P = 6.07 × 10(-4)) in African Americans (r = 0.14; 95% CI, 0.02-0.26; P = 0.003) than in European-Americans (r = 0.36; 95% CI, 0.31-0.40; P = 0.0001). ","[{'ForeName': 'A Joseph', 'Initials': 'AJ', 'LastName': 'Bloom', 'Affiliation': '1 Department of Psychiatry, and.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Hartz', 'Affiliation': ''}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': ''}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': ''}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Laurie', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goate', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201401-010OC'] 422,25073833,Interplay of genetic risk (CHRNA5) and environmental risk (partner smoking) on cigarette smoking reduction.,"BACKGROUND This study tests whether the genetic predictor (CHRNA5 nicotine receptor gene variants) and an environmental risk factor (partner smoking) interact in the prediction of smoking reduction. METHODS Subjects were from a community-based, longitudinal study of women (n=1856) who smoked before pregnancy, and a randomized comparative effectiveness smoking cessation trial (n=1065). Smoking reduction was defined as the trajectory of self-reported smoking quantities over time in the observational study, and as the trajectory of alveolar CO levels in the cessation trial. RESULTS In the pregnancy study, rs16969968 genotype and partner smoking status interacted such that the smoking reduction was lowest for expectant mothers with high genetic risk and partner smoking, and highest for those with high genetic risk but not partner smoking (interaction of genotype×partner smoking on smoking quantity trajectory slope β=0.071, 95%CI=0.013, 0.13, p=0.017). In the clinical trial, a similar interaction was found (interaction β=0.20, 95%CI=0.049, 0.36, p=0.010). Furthermore, these associations were moderated by pharmacotherapy such that the interactive relation of genetic and environmental factors occurred in the placebo group, but not in the active pharmacotherapy group (interaction of genotype×partner smoking×pharmacotherapy on CO trajectory slope β=-0.25, 95%CI=-0.42, -0.091, p=0.0023). CONCLUSIONS The CHRNA5 genetic risk synergized the effect of partner smoking, producing an especially low likelihood of successful smoking reduction in two complementary studies. This suggests that the genetic vulnerability may be mitigated by altering environmental factors. In addition, cessation pharmacotherapy neutralizes the increase in cessation failure associated with combined genetic and environmental risks, which has possible relevance to treatment algorithms.",2014,"In the clinical trial, a similar interaction was found (interaction β=0.20, 95%CI=0.049, 0.36, p=0.010).","['Subjects were from a community-based, longitudinal study of women (n=1856) who smoked before pregnancy, and a randomized comparative effectiveness smoking cessation trial (n=1065']",['placebo'],"['alveolar CO levels', 'interactive relation of genetic and environmental factors', 'Smoking reduction']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0154373,"In the clinical trial, a similar interaction was found (interaction β=0.20, 95%CI=0.049, 0.36, p=0.010).","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, United States. Electronic address: chenli@psychiatry.wustl.edu.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI 53711, United States.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI 53711, United States.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Tobacco Research and Intervention, University of Wisconsin, School of Medicine, Madison, WI 53711, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110, United States.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Grucza', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, United States.'}, {'ForeName': 'George Davey', 'Initials': 'GD', 'LastName': 'Smith', 'Affiliation': 'Avon Longitudinal Study of Parents and Children (ALSPAC), School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom; MRC Integrative Epidemiology Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Munafo', 'Affiliation': 'MRC Integrative Epidemiology Unit, University of Bristol, Bristol, United Kingdom; UK Centre for Tobacco and Alcohol Studies, School of Experimental Psychology, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2014.06.027'] 423,30816331,"Treatment of higher risk acute lymphoblastic leukemia in young people (CCG-1961), long-term follow-up: a report from the Children's Oncology Group.","Children's Cancer Group CCG-1882 improved outcome for 1-21-year old with high risk acute lymphoblastic leukemia and Induction Day 8 marrow blasts ≥25% (slow early responders, SER) with longer and stronger post induction intensification (PII). This CCG-1961 explored alternative PII strategies. We report 10-year follow-up for patients with rapid early response (RER) and for the first time details our experience for SER patients. A total of 2057 patients were enrolled, and 1299 RER patients were randomized to 1 of 4 PII regimens: standard vs. augmented intensity and standard vs. increased length. At the end of interim maintenance, 447 SER patients were randomized to idarubicin/cyclophosphamide or weekly doxorubicin in the delayed intensification phases. The 10-year EFS for RER were 79.4 ± 2.4% and 70.9 ± 2.6% (hazard ratio = 0.65, 95% CI 0.52-0.82, p < 0.001) for augmented and standard strength PII; the 10-year OS rates were 87.2 ± 2.0% and 81.0 ± 2.2% (hazard ratio = 0.64, 95% CI 0.48-0.86, p = 0.003). Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin. The EFS and OS advantage of augmented PII is sustained at 10 years for RER patients. Longer PII for RER patients and sequential idarubicin/cyclophosphamide for SER patients offered no advantage. CCG-1961 is the platform for subsequent COG studies.",2019,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","['patients with rapid early response (RER) and for the first time\xa0details our experience for SER patients', '447 SER patients', '2057 patients were enrolled, and 1299 RER patients']","['idarubicin/cyclophosphamide and weekly doxorubicin', 'idarubicin/cyclophosphamide or weekly doxorubicin', 'idarubicin/cyclophosphamide', 'CCG-1961']","['10-year OS rates', '10-year EFS for RER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2057.0,0.0559644,"Outcomes remain similar for standard and longer PII, and for SER patients assigned to idarubicin/cyclophosphamide and weekly doxorubicin.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. steinhep@mskcc.org.'}, {'ForeName': 'Nita L', 'Initials': 'NL', 'LastName': 'Seibel', 'Affiliation': ""Children's National Health System, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Los Angeles, CA, USA.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}]",Leukemia,['10.1038/s41375-019-0422-z'] 424,30968123,"Percent Fat Mass Increases with Recovery, But Does Not Vary According to Dietary Therapy in Young Malian Children Treated for Moderate Acute Malnutrition.","BACKGROUND Moderate acute malnutrition (MAM) affects 34.1 million children globally. Treatment effectiveness is generally determined by the amount and rate of weight gain. Body composition (BC) assessment provides more detailed information on nutritional stores and the type of tissue accrual than traditional weight measurements alone. OBJECTIVE The aim of this study was to compare the change in percentage fat mass (%FM) and other BC parameters among young Malian children with MAM according to receipt of 1 of 4 dietary supplements, and recovery status at the end of the 12-wk intervention period. METHODS BC was assessed using the deuterium oxide dilution method in a subgroup of 286 children aged 6-35 mo who participated in a 12-wk community-based, cluster-randomized effectiveness trial of 4 dietary supplements for the treatment of MAM: 1) lipid-based, ready-to-use supplementary food (RUSF); 2) special corn-soy blend ""plus plus"" (CSB++); 3) locally processed, fortified flour (MI); or 4) locally milled flours plus oil, sugar, and micronutrient powder (LMF). Multivariate linear regression modeling was used to evaluate change in BC parameters by treatment group and recovery status. RESULTS Mean ± SD %FM at baseline was 28.6% ± 5.32%. Change in %FM did not vary between groups. Children who received RUSF vs. MI gained more (mean; 95% CI) weight (1.43; 1.13, 1.74 kg compared with 0.84; 0.66, 1.03 kg; P = 0.02), FM (0.70; 0.45, 0.96 kg compared with 0.20; 0.05, 0.36 kg; P = 0.01), and weight-for-length z score (1.23; 0.79, 1.54 compared with 0.49; 0.34, 0.71; P = 0.03). Children who recovered from MAM exhibited greater increases in all BC parameters, including %FM, than children who did not recover. CONCLUSIONS In this study population, children had higher than expected %FM at baseline. There were no differences in %FM change between groups. International BC reference data are needed to assess the utility of BC assessment in community-based management of acute malnutrition programs. This trial was registered at clinicaltrials.gov as NCT01015950.",2019,"Children who recovered from MAM exhibited greater increases in all BC parameters, including %FM, than children who did not recover. ","['286 children aged 6-35 mo who participated in a 12-wk community-based, cluster-randomized effectiveness trial of 4', 'Young Malian Children Treated for Moderate Acute Malnutrition', 'young Malian children with MAM according to receipt of 1 of 4 dietary supplements, and recovery status at the end of the 12-wk intervention period']","['dietary supplements', 'Dietary Therapy', 'MAM: 1) lipid-based, ready-to-use supplementary food (RUSF); 2) special corn-soy blend ""plus plus"" (CSB++); 3) locally processed, fortified flour (MI); or 4) locally milled flours plus oil, sugar, and micronutrient powder (LMF', 'deuterium oxide dilution method', 'RUSF vs. MI']","['rate of weight gain', 'FM change', 'BC parameters', 'Mean\xa0±\xa0SD %FM', 'weight-for-length z score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0079240', 'cui_str': 'Dilution Technics'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",286.0,0.327721,"Children who recovered from MAM exhibited greater increases in all BC parameters, including %FM, than children who did not recover. ","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ackatia-Armah', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA.'}, {'ForeName': 'Seydou', 'Initials': 'S', 'LastName': 'Doumbia', 'Affiliation': 'Department of Public Health, Faculty of Medicine, University of Bamako, Bamako, Mali.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Kupka', 'Affiliation': 'Nutrition Section, UNICEF, New York, NY.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA.'}]",The Journal of nutrition,['10.1093/jn/nxz037'] 425,32265061,"A Phase I Study on the Pharmacokinetics and Pharmacodynamics of DJT1116PG, a Novel Selective Inhibitor of Sodium-glucose Cotransporter Type 2, in Healthy Individuals at Steady State.","PURPOSE DJT1116PG, which selectively inhibits renal glucose reabsorption by inhibiting sodium-glucose cotransporter type 2, was developed as an insulin-independent treatment for type 2 diabetes mellitus. This Phase I trial evaluated the pharmacokinetic and pharmacodynamic properties of DJT1116PG at steady state in healthy Chinese individuals. METHODS This was a multiple ascending dose study of DJT1116PG (20, 50, and 100 mg once daily for 7 days) that included 36 healthy individuals. FINDINGS There were no serious adverse events or deaths in these studies, and no adverse event led to study discontinuation. Oral DJT1116PG was rapidly absorbed with a T max of 0.75-1.5 h and a t ½ of 12-16.2 h. Systemic exposure (C max and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner. Urinary glucose excretion (UGE) plateaued at 50 mg of DJT1116PG in a previous single ascending dose study and on day 1 of this study. UGE plateaued at 20 mg of DJT1116PG on day 7 of this study. Serum glucose parameters were similar in individuals who received DJT1116PG or placebo. IMPLICATIONS DJT1116PG was well tolerated in healthy Chinese individuals. At steady state, UGE plateaued at 20 mg of DJT1116PG in these individuals. These findings will inform the selection of doses for further early-stage clinical trials of DJT1116PG. Chinese Drug Trial Identifier: CTR20160986.",2020,"Oral DJT1116PG was rapidly absorbed with a T max of 0.75-1.5 h and a t ½ of 12-16.2 h. Systemic exposure (C max and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner.","['Healthy Individuals at Steady State', 'type 2 diabetes mellitus', 'healthy Chinese individuals', '36 healthy individuals']","['Oral DJT1116PG', 'DJT1116PG or placebo', 'DJT1116PG']","['Urinary glucose excretion (UGE', 'Serum glucose parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",36.0,0.0531884,"Oral DJT1116PG was rapidly absorbed with a T max of 0.75-1.5 h and a t ½ of 12-16.2 h. Systemic exposure (C max and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: wumin1987mary@126.com.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: yanhuad2019@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.007'] 426,32267058,"Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.","Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are recommended for glycaemic management in patients with type 2 diabetes (T2D). Oral semaglutide, the first oral GLP-1RA, has recently been approved for clinical use, based on the results of the randomized, Phase 3a Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) clinical trials. The PIONEER programme tested oral semaglutide in patients with T2D of duration ranging from 3.5 to 15 years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients. Outcomes (glycated haemoglobin [HbA1c] and body weight reduction, plus other relevant efficacy and safety endpoints) were tested against both placebo and active standard-of-care medications. A separate trial evaluated the cardiovascular safety of oral semaglutide in patients with T2D at high cardiovascular risk. Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose. Oral semaglutide provided significantly better efficacy than placebo and commonly used glucose-lowering medications from the dipeptidyl peptidase-4 inhibitor (sitagliptin) and sodium-glucose co-transporter-2 inhibitor (empagliflozin) classes, as well as the subcutaneous GLP-1RAs liraglutide and dulaglutide. Oral semaglutide was well tolerated in line with the known safety profile of GLP-1RAs, with transient gastrointestinal events being the most common side effects reported. Cardiovascular safety was demonstrated for oral semaglutide in patients with cardiovascular disease or high cardiovascular risk. The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D. The availability of oral semaglutide may help to broaden treatment choice and facilitate adoption of earlier GLP-1RA treatment in the paradigm of T2D management.",2020,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","['patients with type 2 diabetes (T2D', 'patients with type 2 diabetes', 'patients with cardiovascular disease or high cardiovascular risk', 'patients with T2D at high cardiovascular risk', 'patients with T2D of duration ranging from 3.5 to 15\u2009years, from monotherapy through to insulin add-on, in global populations and two trials dedicated to Japanese patients']","['Glucagon-like peptide-1 receptor agonists (GLP-1RAs', 'once-daily oral semaglutide', 'placebo', 'oral semaglutide']","['Efficacy, safety and cardiovascular outcomes', 'Outcomes (glycated haemoglobin', 'Cardiovascular safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}]",,0.0294568,"Over periods of treatment up to 78 weeks, oral semaglutide 7 and 14 mg once daily reduced HbA 1c and body weight across the spectrum of T2D, and improved other diabetes-related endpoints, such as fasting plasma glucose.","[{'ForeName': 'Tina K', 'Initials': 'TK', 'LastName': 'Thethi', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Centre Bochum-Hattingen, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14054'] 427,30854728,Transcranial direct current stimulation over the sensory-motor regions inhibits gamma synchrony.,"Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique able to induce plasticity phenomena. Although tDCS application has been spreading over a variety of neuroscience domains, the mechanisms by which the stimulation acts are largely unknown. We investigated tDCS effects on cortical gamma synchrony, which is a crucial player in cortical function. We performed a randomized, sham-controlled, double-blind study on healthy subjects, combining tDCS and magnetoencephalography. By driving brain activity via 40 Hz auditory stimulation during magnetoencephalography, we experimentally tuned cortical gamma synchrony and measured it before and after bilateral tDCS of the primary sensory-motor hand regions (anode left, cathode right). We demonstrated that the stimulation induces a remarkable decrease of gamma synchrony (13 out of 15 subjects), as measured by gamma phase at 40 Hz. tDCS has strong remote effects, as the cortical region mostly affected was located far away from the stimulation site and covered a large area of the right centro-temporal cortex. No significant differences between stimulations were found for baseline gamma synchrony, as well as early transient auditory responses. This suggests a specific tDCS effect on externally driven gamma synchronization. This study sheds new light on the effect of tDCS on cortical function showing that the net effect of the stimulation on cortical gamma synchronization is an inhibition.",2019,"No significant differences between stimulations were found for baseline gamma synchrony, as well as early transient auditory responses.","['healthy subjects, combining tDCS and magnetoencephalography']","['Transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['gamma synchrony', 'baseline gamma synchrony, as well as early transient auditory responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",15.0,0.100568,"No significant differences between stimulations were found for baseline gamma synchrony, as well as early transient auditory responses.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pellegrino', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Arcara', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Pino', 'Affiliation': 'Department of Neurology, NeXT: Neurophysiology and Neuroengineering of Human-Technology Interaction Research Unit, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Turco', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Maran', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Weis', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piccione', 'Affiliation': 'Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}]",Human brain mapping,['10.1002/hbm.24556'] 428,30859709,Resting-state fMRI detects the effects of learning in short term: A visual search training study.,"Can resting-state functional connectivity (rs-FC) detect the impact of learning on the brain in the short term? To test this possibility, we have combined task-FC and rs-FC tested before and after a 30-min visual search training. Forty-two healthy adults (20 men) divided into no-contact control and trained groups completed the study. We studied the connectivity between four different regions of the brain involved in visual search: the primary visual area, the right posterior parietal cortex (rPPC), the right dorsolateral prefrontal cortex (rDLPFC), and the dorsal anterior cingulate cortex (dACC). Task-FC showed increased connectivity between the rPPC and rDLPFC and between the dACC and rDLPFC from pretraining to posttraining for both the control group and the trained group, suggesting that connectivity between these areas increased with task repetition. In rs-FC, we found enhanced connectivity between these regions in the trained group after training, especially in those with better learning. Whole brain independent component analyses did not reveal any change in main networks after training. These results imply that rs-FC may not only predict individual differences in task performance, but rs-FC might also serve to monitor the impact of learning on the brain after short periods of cognitive training, localizing them in brain areas specifically involved in training.",2019,"Task-FC showed increased connectivity between the rPPC and rDLPFC and between the dACC and rDLPFC from pretraining to posttraining for both the control group and the trained group, suggesting that connectivity between these areas increased with task repetition.","['short term', 'Forty-two healthy adults (20 men) divided into no-contact control and trained groups completed the study']",[],"['right posterior parietal cortex (rPPC), the right dorsolateral prefrontal cortex (rDLPFC), and the dorsal anterior cingulate cortex (dACC', 'task repetition']","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0456855', 'cui_str': 'Right posterior (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}]",42.0,0.0134955,"Task-FC showed increased connectivity between the rPPC and rDLPFC and between the dACC and rDLPFC from pretraining to posttraining for both the control group and the trained group, suggesting that connectivity between these areas increased with task repetition.","[{'ForeName': 'Elisenda', 'Initials': 'E', 'LastName': 'Bueichekú', 'Affiliation': 'Neuropsychology and Functional Neuroimaging Group, Department of Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miró-Padilla', 'Affiliation': 'Neuropsychology and Functional Neuroimaging Group, Department of Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Ávila', 'Affiliation': 'Neuropsychology and Functional Neuroimaging Group, Department of Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain.'}]",Human brain mapping,['10.1002/hbm.24560'] 429,30911113,"Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia.","Telomere length in chronic lymphocytic leukemia (CLL) has been shown to be of prognostic importance, but the analyses have largely been executed on heterogeneous patient cohorts outside of clinical trials. In the present study, we performed a comprehensive analysis of telomere length associations in the well characterized CLL8 trial (n = 620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n = 293). Absolute telomere length was analyzed using quantitative-PCR. Apart from identifying associations of short telomere length with adverse prognostic factors and survival, the study identified cases with 17p- and 11q- associated with TP53 and ATM loss, respectively, to have the shortest telomeres, even when these aberrations were present in small subclones. Thus, telomere shortening may precede acquisition of the high-risk aberrations, contributing to disease evolution. In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.",2019,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","['well characterized CLL8 trial (n\u2009=\u2009620) of the German CLL study group, with validation in a representative cohort of the CLL4 trial (n\u2009=\u2009293', 'chronic lymphocytic leukemia (CLL', 'chronic lymphocytic leukemia']",[],"['TP53 and ATM loss', 'Absolute telomere length', 'genomic complexity']","[{'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0678214', 'cui_str': 'atmosphere (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",,0.0234911,"In line with this, telomere shortening was associated with an increase in genomic complexity as well as clonal evolution, highlighting its importance as a biomarker especially in monitoring disease progression in non-high-risk CLL.","[{'ForeName': 'Billy Michael Chelliah', 'Initials': 'BMC', 'LastName': 'Jebaraj', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Dan A', 'Initials': 'DA', 'LastName': 'Landau', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Amaro N', 'Initials': 'AN', 'LastName': 'Taylor-Weiner', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bloehdorn', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Scheffold', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mertens', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Department II of Internal Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jäger', 'Affiliation': 'Department of Medicine I, Division of Hematology and Hemostaeology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Zenz', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Wenger', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wendtner', 'Affiliation': 'Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Broad Institute, Cambridge, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I for Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, Ulm University, Ulm, Germany. stephan.stilgenbauer@uniklinik-ulm.de.'}]",Leukemia,['10.1038/s41375-019-0446-4'] 430,32252983,Telemedicine to follow patients in a general surgery department. A randomized controlled trial.,"BACKGROUND Telemedicine is becoming more popular in many medical specialties but few studies have been conducted in General Surgery. This study aims to evaluate the feasibility of its introduction in this specialty. METHODS A prospective randomized clinical trial (RCT) was conducted in 200 patients to compare conventional vs telemedicine follow-up in the outpatient clinics. The primary outcome was the feasibility of telemedicine follow-up and the secondary outcomes were its clinical impact and patient satisfaction. RESULTS Patients were enrolled between March 2017 and April 2018 and there were no statistically significant differences between the groups' characteristics. The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003). No differences were found in clinical outcomes (P = 0.832) or patient satisfaction (P = 0.099). CONCLUSION Telemedicine is a good complementary service to facilitate follow-up management in selected patients from a General Surgery department.",2020,The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003).,"['selected patients from a General Surgery department', '200 patients to compare conventional vs telemedicine follow-up in the outpatient clinics']","['telemedicine', 'Telemedicine']","['patient satisfaction', 'clinical outcomes', 'clinical impact and patient satisfaction', 'feasibility of telemedicine follow-up and the secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.181944,The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003).,"[{'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Cremades', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain. Electronic address: cirurgiageneral.germanstrias@gencat.cat.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Ferret', 'Affiliation': 'General Surgery, Hospital Universitari Doctor Josep Trueta, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parés', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navinés', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Franc', 'Initials': 'F', 'LastName': 'Espin', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pardo', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Caballero', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Viciano', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Joan Francesc', 'Initials': 'JF', 'LastName': 'Julian', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.03.023'] 431,32162808,"Prognostic and Predictive Value of Microsatellite Instability, Inflammatory Reaction and PD-L1 in Gastric Cancer Patients Treated with Either Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel: A Translational Analysis from the ITACA-S Trial.","BACKGROUND Patients with high microsatellite instability (MSI) gastric cancer (GC) show improved survival and no benefit or harm from adjuvant and/or perioperative chemotherapy. The role of immune microenvironment in GC is largely unknown. MATERIALS AND METHODS In the present study, 256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S, a randomized adjuvant trial of 5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel. MSI status was assessed by multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry. RESULTS Overall, 9% patients had MSI-high tumors, 23% had high inflammatory reaction, 11% had tumor PD-L1 ≥ 1%, and 11% had stromal PD-L1 ≥ 1%. A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1. At multivariable analysis, only MSI showed an independent association with both DFS (p = .02) and OS (p = .01), whereas inflammatory reaction showed an independent association only with OS (p = .04). Patients with tumor PD-L1 ≥ 1% had a significantly longer DFS in sequential chemotherapy than in than 5-FU/LV arm (interaction p = .04) and a trend for OS (interaction p = .12). CONCLUSION Our data suggest that MSI status could be a useful prognostic biomarker in patients with radically resected stage II-III GC and should be used as stratification factor in future trials. Tumor PD-L1 ≥ 1% should be further investigated as a potential predictor of benefit from intensive chemotherapy. IMPLICATIONS FOR PRACTICE In this post hoc analysis of patients with radically resected gastric cancer randomized to an intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy as adjuvant treatment in the ITACA-S trial, MSI-high status was independently associated with better disease-free survival and overall survival (OS) and inflammatory reaction was independently associated with better OS. Moreover, tumor PD-L1 expression ≥1% was associated with greater benefit from intensive sequential chemotherapy compared with 5-fluorouracil plus leucovorin (5-FU/LV), whereas PD-L1 expression <1% was not, conditioning a statistically significant interaction between such biomarker and treatment arms. The meta-analysis of individual patients' data from available studies could yield data on the role of MSI status that could inform clinical decisions.",2020,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1.","['256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S', 'patients with radically resected gastric cancer', 'Gastric Cancer Patients Treated with Either', 'Patients with high microsatellite instability (MSI) gastric cancer (GC']","['5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel', 'intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy', '5-FU/LV', '5-fluorouracil plus leucovorin (5-FU/LV', 'Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel']","['multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry', 'DFS', 'disease-free survival (DFS) and overall survival (OS', 'high inflammatory reaction', 'MSI status', 'PD-L1 expression', 'inflammatory reaction', 'disease-free survival and overall survival (OS) and inflammatory reaction']","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0920269', 'cui_str': 'Microsatellite Instability'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C3179032', 'cui_str': 'Multiplex PCR'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.129712,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Antista', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Niger', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pellegrinelli', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Randon', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0471'] 432,32162813,Phase IIIb Safety and Efficacy of Intravenous NEPA for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients with Breast Cancer Receiving Initial and Repeat Cycles of Anthracycline and Cyclophosphamide (AC) Chemotherapy.,"BACKGROUND NEPA, a combination antiemetic of a neurokinin-1 (NK 1 ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3 RA, palonosetron] offers 5-day CINV prevention with a single dose. Fosnetupitant solution contains no allergenic excipients, surfactant, emulsifier, or solubility enhancer. A phase III study of patients receiving cisplatin found no infusion-site or anaphylactic reactions related to IV NEPA. However, hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1 RAs, particularly fosaprepitant in patients receiving anthracycline-cyclophosphamide (AC)-based chemotherapy. This study evaluated the safety and efficacy of IV NEPA in the AC setting. MATERIALS AND METHODS This phase IIIb, multinational, randomized, double-blind study enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy. Patients were randomized to receive a single 30-minute infusion of IV NEPA or single oral NEPA capsule on day 1 prior to AC, in repeated (up to 4) cycles. Oral dexamethasone was given to all patients on day 1 only. RESULTS A total of 402 patients were included. The adverse event (AE) profiles were similar for IV and oral NEPA and consistent with those expected. Most AEs were mild or moderate with a similarly low incidence of treatment-related AEs in both groups. There were no treatment-related injection-site AEs and no reports of hypersensitivity or anaphylaxis. The efficacy of IV and oral NEPA were similar, with high complete response (no emesis/no rescue) rates observed in cycle 1 (overall [0-120 hours] 73.0% IV NEPA, 77.3% oral NEPA) and maintained over subsequent cycles. CONCLUSION IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC. IMPLICATIONS FOR PRACTICE As a combination of a neurokinin-1 (NK 1 ) receptor antagonist (RA) and 5-HT 3 RA, NEPA offers 5-day chemotherapy-induced nausea and vomiting prevention with a single dose and an opportunity to improve adherence to antiemetic guidelines. In this randomized multinational phase IIIb study, intravenous (IV) NEPA (fosnetupitant/palonosetron) was safe and highly effective in patients receiving multiple cycles of anthracycline-cyclophosphamide (AC)-based chemotherapy. Unlike other IV NK 1 RAs, the IV NEPA combination solution does not require any surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. Hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1 RAs, most commonly with fosaprepitant in the AC setting. Importantly, there were no injection-site or hypersensitivity reactions associated with IV NEPA.",2020,"CONCLUSION IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC. ","['patients receiving AC', 'patients receiving multiple cycles of', 'enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy', 'Patients with Breast Cancer', 'A total of 402 patients were included']","['Oral dexamethasone', 'IV and oral NEPA', 'neurokinin-1 (NK 1 ) receptor antagonist (RA) and 5-HT 3 RA, NEPA', 'neurokinin-1 (NK 1 ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3 RA, palonosetron', 'Anthracycline and Cyclophosphamide', 'IV NEPA', 'intravenous (IV) NEPA (fosnetupitant/palonosetron', 'Intravenous NEPA', 'cisplatin', 'IV NEPA or single oral NEPA capsule', 'anthracycline-cyclophosphamide (AC)-based chemotherapy']","['adverse event (AE) profiles', 'hypersensitivity and injection-site reactions', 'injection-site or hypersensitivity reactions', 'Nausea and Vomiting (CINV', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4691680', 'cui_str': 'fosnetupitant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",402.0,0.0576046,"CONCLUSION IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC. ","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'Hematology & Oncology, West Cancer Center, Germantown, Tennessee, USA.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Navari', 'Affiliation': 'Department of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Clark-Snow', 'Affiliation': 'Overland Park, Kansas, USA.'}, {'ForeName': 'Ekaterine', 'Initials': 'E', 'LastName': 'Arkania', 'Affiliation': 'The Institute of Clinical Oncology, Tbilisi, Georgia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Radyukova', 'Affiliation': 'Department of Chemotherapy, Clinical Oncology Center, Omsk, Russia.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'CARTI Cancer Center, Little Rock, Arkansas, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wickham', 'Affiliation': 'Rapid River, Michigan, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Department of Medical Oncology, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': 'Cancer Centre, Clinique de Genolier, Genolier, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roeland', 'Affiliation': 'Oncology & Palliative Care, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0527'] 433,32162816,Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial.,"BACKGROUND Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer. MATERIALS AND METHODS Eligible adult patients (≥18 years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score ≥17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and ≥4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress. RESULTS Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31-59) for olanzapine and 57% (95% CI, 43-71) for haloperidol (Δ DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2-1.4; p = .23). Mean TTR was 4.5 days (95% CI, 3.2-5.9 days) for olanzapine and 2.8 days (95% CI, 1.9-3.7 days; p = .18) for haloperidol. Grade ≥3 treatment-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility. CONCLUSION Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol. Clinical trial identification number. NCT01539733. Dutch Trial Register. NTR2559. IMPLICATIONS FOR PRACTICE Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.",2020,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","['Eligible adult patients (≥18\u2009years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98', 'Patients with Advanced Cancer', 'hospitalized patients with advanced cancer', 'patients with advanced cancer', 'patients with cancer', 'Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis', 'adults with cancer']","['haloperidol', 'Olanzapine', 'haloperidol or olanzapine', 'Olanzapine Versus Haloperidol', 'olanzapine with haloperidol', 'olanzapine']","['efficacy and tolerability', 'Mean TTR', 'overall better safety profile', 'efficacy and safety', 'time to response (TTR), tolerability, and delirium-related distress', 'DRR or TTR', 'Distress rates', 'delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score', 'Grade ≥3 treatment-related adverse events', 'DRR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0222045'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",98.0,0.161751,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","[{'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth C W', 'Initials': 'ECW', 'LastName': 'Neefjes', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Manon S A', 'Initials': 'MSA', 'LastName': 'Boddaert', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Bea A T T', 'Initials': 'BATT', 'LastName': 'Verdegaal', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Saskia C C', 'Initials': 'SCC', 'LastName': 'Teunissen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke A', 'Initials': 'JA', 'LastName': 'Wilschut', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter W A', 'Initials': 'WWA', 'LastName': 'Zuurmond', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0470'] 434,32162821,Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.,"LESSONS LEARNED It is possible to plan and treat some patients with stereotactic body radiotherapy (SBRT) in a timely fashion in an acute setting. Advanced and, in some indications, already implemented technologies such as SBRT are difficult to test in a randomized trial. BACKGROUND Stereotactic body radiotherapy (SBRT) in metastatic spinal cord compression (MSCC) could be an alternative to decompressive surgery followed by fractionated radiotherapy. METHODS In a randomized, single-institution, noninferiority trial, patients with MSCC were assigned to stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy of 30 Gy in 10 fractions. Primary endpoint was ability to walk by EQ5D-5L questionnaire. Based on power calculations, 130 patients had to be included to be 89% sure that a 15% difference between the treatment arm and the experimental arm could be detected. RESULTS Ten patients were accrued in 23 months, with six patients allocated to surgery and four patients to stereotactic body radiotherapy. The trial was closed prematurely because of poor accrual. One patient undergoing surgery and one patient undergoing stereotactic body radiotherapy were unable to walk at 6 weeks. Two patients were not evaluable at 6 weeks. CONCLUSION A randomized, phase II, clinical trial comparing surgery followed by fractionated radiotherapy or image-guided SBRT of MSCC was initiated. SBRT was shown to be feasible, with three out of four patients retaining walking function. The trial was determined futile as a result of low accrual.",2020,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","['Metastatic Spinal Cord Compression', 'patients with MSCC', 'metastatic spinal cord compression (MSCC']","['stereotactic body radiotherapy', 'Stereotactic body radiotherapy (SBRT', 'SBRT', 'stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy', 'Image-Guided Stereotactic Body Radiotherapy', 'stereotactic body radiotherapy (SBRT', 'fractionated radiotherapy']",['ability to walk by EQ5D-5L questionnaire'],"[{'cui': 'C4076184', 'cui_str': 'Spinal cord compression due to metastasis to spine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",2.0,0.139858,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","[{'ForeName': 'Morten Hiul', 'Initials': 'MH', 'LastName': 'Suppli', 'Affiliation': 'Department of Oncology, Section of Radiotherapy, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Munck Af Rosenschold', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Dahl', 'Affiliation': 'Spine Unit, Department of Orthopaedic Surgery, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kiil', 'Initials': 'AK', 'LastName': 'Berthelsen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Svend Aage', 'Initials': 'SA', 'LastName': 'Engelholm', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}]",The oncologist,['10.1634/theoncologist.2019-0672'] 435,30860570,"BEECH: a dose-finding run-in followed by a randomised phase II study assessing the efficacy of AKT inhibitor capivasertib (AZD5363) combined with paclitaxel in patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population.","BACKGROUND BEECH investigated the efficacy of capivasertib (AZD5363), an oral inhibitor of AKT isoforms 1-3, in combination with the first-line weekly paclitaxel for advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and in a phosphoinositide 3-kinase, catalytic, alpha polypeptide mutation sub-population (PIK3CA+). PATIENTS AND METHODS BEECH consisted of an open-label, phase Ib safety run-in (part A) in 38 patients with advanced breast cancer, and a randomised, placebo-controlled, double-blind, phase II expansion (part B) in 110 women with ER+/HER2- metastatic breast cancer. In part A, patients received paclitaxel 90 mg/m2 (days 1, 8 and 15 of a 28-day cycle) with capivasertib taken twice daily (b.i.d.) at two intermittent ascending dosing schedules. In part B, patients were randomly assigned, stratified by PIK3CA mutation status, to receive paclitaxel with either capivasertib or placebo. The primary end point for part A was safety to recommend a dose and schedule for part B; primary end points for part B were progression-free survival (PFS) in the overall and PIK3CA+ sub-population. RESULTS Capivasertib was well tolerated, with a 400 mg b.i.d. 4 days on/3 days off treatment schedule selected in part A. In part B, median PFS in the overall population was 10.9 months with capivasertib versus 8.4 months with placebo [hazard ratio (HR) 0.80; P = 0.308]. In the PIK3CA+ sub-population, median PFS was 10.9 months with capivasertib versus 10.8 months with placebo (HR 1.11; P = 0.760). Based on the Common Terminology Criteria for Adverse Event v4.0, the most common grade ≥3 adverse events in the capivasertib group were diarrhoea, hyperglycaemia, neutropoenia and maculopapular rash. Dose intensity of paclitaxel was similar in both groups. CONCLUSIONS Capivasertib had no apparent impact on the tolerability and dose intensity of paclitaxel. Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.ClinicalTrials.gov: NCT01625286.",2019,Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.,"['38 patients with advanced breast cancer', 'patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population', '110 women with ER+/HER2- metastatic breast cancer', 'metastatic breast cancer patients']","['placebo', 'capivasertib (AZD5363', 'paclitaxel', 'paclitaxel with either capivasertib or placebo', 'BEECH', 'AKT inhibitor capivasertib (AZD5363) combined with paclitaxel']","['median PFS', 'progression-free survival (PFS', 'tolerability and dose intensity of paclitaxel', 'diarrhoea, hyperglycaemia, neutropoenia and maculopapular rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0950075', 'cui_str': 'Fagaceae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash (morphologic abnormality)'}]",110.0,0.148122,Adding capivasertib to weekly paclitaxel did not prolong PFS in the overall population or PIK3CA+ sub-population of ER+/HER2- advanced/metastatic breast cancer patients.,"[{'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Unit, The Royal Marsden NHS Foundation Trust, London, UK; Breast Cancer Now Research Centre, The Institute of Cancer Research, London, UK. Electronic address: Nick.Turner@icr.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alarcón', 'Affiliation': 'Clinical Oncology Department, British American Hospital, Lima, Peru.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Medical Oncology, Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Philco', 'Affiliation': 'Peruvian Institute of Oncology Radiotherapy, Lima, Peru.'}, {'ForeName': 'Y A', 'Initials': 'YA', 'LastName': 'López Chuken', 'Affiliation': 'University Hospital, Monterrey, Mexico.'}, {'ForeName': 'M-P', 'Initials': 'MP', 'LastName': 'Sablin', 'Affiliation': 'Department of Drug Development and Innovation (D3i), Curie Institute, Paris, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gómez Villanueva', 'Affiliation': 'Clinical Oncology Unit, Private Hemato-Oncology Center, Toluca, Mexico.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Pérez-Fidalgo', 'Affiliation': 'Medical Oncology Unit, INCLIVA Biomedical Research Institute, University Clinical Hospital of Valencia, Valencia; CIBERONC, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'S Y A', 'Initials': 'SYA', 'LastName': 'Cheung', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Corcoran', 'Affiliation': 'Precision Medicine and Genomics, IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cullberg', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Davies', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'de Bruin', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'J P O', 'Initials': 'JPO', 'LastName': 'Lindemann', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maudsley', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moschetta', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Outhwaite', 'Affiliation': 'Anchora Consultancy Ltd, Devon, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pass', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rugman', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz086'] 436,30773030,Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia.,"BACKGROUND There is no consensus on how, when, or at what intensity exercise should be performed after heart transplantation (HTx). We have recently shown that high-intensity interval training (HIT) is safe, well tolerated, and efficacious in the maintenance state after HTx, but studies have not investigated HIT effects in the de novo HTx state. We hypothesized that HIT could be introduced early after HTx and that it could lead to clinically meaningful increases in exercise capacity and health-related quality of life. METHODS This multicenter, prospective, randomized, controlled trial included 81 patients a mean of 11 weeks (range, 7-16 weeks) after an HTx. Patients were randomized 1:1 to 9 months of either HIT (4×4-minute intervals at 85%-95% of peak effort) or moderate-intensity continuous training (60%-80% of peak effort). The primary outcome was the effect of HIT versus moderate-intensity continuous training on the change in aerobic exercise capacity, assessed as the peak oxygen consumption (Vo 2 peak). Secondary outcomes included tolerability, safety, adverse events, isokinetic muscular strength, body composition, health-related quality of life, left ventricular function, hemodynamics, endothelial function, and biomarkers. RESULTS From baseline to follow-up, 96% of patients completed the study. There were no serious exercise-related adverse events. The population comprised 73% men, and the mean±SD age was 49±13 years. At the 1-year follow-up, the HIT group demonstrated greater improvements than the moderate-intensity continuous training group; the groups showed significantly different changes in the Vo 2 peak (mean difference between groups, 1.8 mL·kg - 1·min - 1), the anaerobic threshold (0.28 L/min), the peak expiratory flow (11%), and the extensor muscle exercise capacity (464 J). The 1.8-mL·kg - 1·min - 1 difference was equal to ≈0.5 metabolic equivalents, which is regarded as clinically meaningful and relevant. Health-related quality of life was similar between the groups, as indicated by results from the Short Form-36 (version 2), Hospital Anxiety and Depression Scale, and a visual analog scale. CONCLUSIONS We demonstrated that HIT was a safe, efficient exercise method in de novo HTx recipients. HIT, compared with moderate-intensity continuous training, resulted in a clinically significantly greater change in exercise capacity based on the Vo 2 peak values (25% versus 15%), anaerobic threshold, peak expiratory flow, and muscular exercise capacity. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier NCT01796379.",2019,"At the 1-year follow-up, the HIT group demonstrated greater improvements than the moderate-intensity continuous training group; the groups showed significantly different changes in the Vo 2 peak (mean difference between groups, 1.8 mL·kg - 1·min - 1), the anaerobic threshold (0.28 L/min), the peak expiratory flow (11%), and the extensor muscle exercise capacity (464 J).","['The population comprised 73% men, and the mean±SD age was 49±13 years', 'De Novo Heart Transplant Recipients in Scandinavia', '81 patients a mean of 11 weeks (range, 7-16 weeks) after an HTx']","['moderate-intensity continuous training', 'High-Intensity Interval Training']","['peak expiratory flow', 'tolerability, safety, adverse events, isokinetic muscular strength, body composition, health-related quality of life, left ventricular function, hemodynamics, endothelial function, and biomarkers', 'Short Form-36 (version 2), Hospital Anxiety and Depression Scale, and a visual analog scale', 'exercise capacity and health-related quality of life', 'serious exercise-related adverse events', 'Health-related quality of life', 'exercise capacity', 'extensor muscle exercise capacity', 'anaerobic threshold, peak expiratory flow, and muscular exercise capacity', 'effect of HIT versus moderate-intensity continuous training on the change in aerobic exercise capacity, assessed as the peak oxygen consumption (Vo 2 peak']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C3714654', 'cui_str': 'Scandinavia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0080310', 'cui_str': 'Left Ventricular Function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",81.0,0.160228,"At the 1-year follow-up, the HIT group demonstrated greater improvements than the moderate-intensity continuous training group; the groups showed significantly different changes in the Vo 2 peak (mean difference between groups, 1.8 mL·kg - 1·min - 1), the anaerobic threshold (0.28 L/min), the peak expiratory flow (11%), and the extensor muscle exercise capacity (464 J).","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Arne Kristian', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Dag Olav', 'Initials': 'DO', 'LastName': 'Dahle', 'Affiliation': 'Transplantation Medicine (D.O.D.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Relbo Authen', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Philip Wigh', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden (J.P.W., K.K.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Have Dall', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark (C.H.D.).'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'University of Copenhagen, Denmark (C.H.D., F.G.).'}, {'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden (J.P.W., K.K.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Departments of Cardiology (K.N., K.R., A.K.A., M.Y., E.G., E.B., A.R.A., I.G., L.G.), Oslo University Hospital Rikshospitalet, Norway.'}]",Circulation,['10.1161/CIRCULATIONAHA.118.036747'] 437,32162822,Talazoparib in Patients with a Germline BRCA-Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial.,"BACKGROUND In the EMBRACA phase III study (NCT01945775), talazoparib was associated with a significantly prolonged progression-free survival (PFS) compared with physician's choice of chemotherapy (PCT) in germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC). Herein, the safety profile of talazoparib is explored in detail. MATERIALS AND METHODS Overall, 412 patients received ≥1 dose of talazoparib (n = 286) or PCT (n = 126). Adverse events (AEs) were evaluated, including timing, duration, and potential overlap of selected AEs. The relationship between talazoparib plasma exposure and grade ≥3 anemia was analyzed. Time-varying Cox proportional hazard models assessed the impact of dose reductions on PFS. Patient-reported outcomes (PROs) in patients with common AEs and health resource utilization (HRU) were assessed in both treatment arms. RESULTS The most common AEs with talazoparib were hematologic (195 [68.2%] patients) and typically occurred within the first 3-4 months of receiving talazoparib. Grade 3-4 anemia lasted approximately 7 days for both arms. Overlapping grade 3-4 hematologic AEs were infrequent with talazoparib. Higher talazoparib exposure was associated with grade ≥3 anemia. Permanent discontinuation of talazoparib due to hematologic AEs was low (<2%). A total of 150 (52.4%) patients receiving talazoparib had AEs associated with dose reduction. Hematologic toxicities were managed by supportive care medication (including transfusion) and dose modifications. Among patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib. After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy. CONCLUSION Talazoparib was associated with superior efficacy, favorable PROs, and lower HRU rate versus chemotherapy in gBRCA-mutated ABC. Toxicities were manageable with talazoparib dose modification and supportive care. IMPLICATIONS FOR PRACTICE Talazoparib was generally well tolerated in patients with germline BRCA-mutated HER2-negative advanced breast cancer in the EMBRACA trial. Common toxicities with talazoparib were primarily hematologic and infrequently resulted in permanent drug discontinuation (<2% of patients discontinued talazoparib due to hematologic toxicity). Hematologic toxicities typically occurred during the first 3-4 months of treatment and were managed by dose modifications and supportive care measures. A significant efficacy benefit, improved patient-reported outcomes, lower rate of health resource utilization and a tolerable safety profile support incorporating talazoparib into routine management of germline BRCA-mutated locally advanced/metastatic breast cancer.",2020,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy. ","['patients with germline BRCA-mutated HER2-negative advanced breast cancer in the EMBRACA trial', 'Overall, 412 patients received ≥1 dose of', 'patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib', 'germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC', 'n =\u2009286) or', 'Patients with a Germline BRCA-Mutated Advanced Breast Cancer']","['PCT', 'talazoparib', 'Talazoparib', 'chemotherapy (PCT']","['timing, duration, and potential overlap of selected AEs', 'talazoparib plasma exposure and grade ≥3 anemia', 'Hematologic toxicities', 'hematologic', 'Toxicities', 'hematologic toxicity', 'superior efficacy, favorable PROs, and lower HRU rate', 'health resource utilization (HRU']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.0470351,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy. ","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'Kaiser Permanente, Northern California, Vallejo, California, USA.'}, {'ForeName': 'Lida A', 'Initials': 'LA', 'LastName': 'Mina', 'Affiliation': 'MD Anderson Cancer Center, Gilbert, Arizona, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'Rocky Mountain Cancer Centers, Littleton, Colorado, USA.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Blum', 'Affiliation': 'Baylor Sammons Cancer Center, Texas Oncology, U.S. Oncology, Dallas, Texas, USA.'}, {'ForeName': 'Jayeta', 'Initials': 'J', 'LastName': 'Chakrabarti', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer, Inc., La Jolla, California, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'DeAnnuntis', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Ruben G W', 'Initials': 'RGW', 'LastName': 'Quek', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}]",The oncologist,['10.1634/theoncologist.2019-0493'] 438,32151367,Randomized phase III and extension studies: efficacy and impacts on quality of life of naldemedine in subjects with opioid-induced constipation and cancer.,"BACKGROUND The efficacy and safety of naldemedine (a peripherally acting µ-opioid receptor antagonist) for opioid-induced constipation (OIC) in subjects with cancer was demonstrated in the primary report of a phase III, double-blind study (COMPOSE-4) and its open-label extension (COMPOSE-5). The primary end point, the proportion of spontaneous bowel movement (SBM) responders, was met. Here, we report results from secondary end points, including quality of life (QOL) assessments from these studies. PATIENTS AND METHODS In COMPOSE-4, eligible adults with OIC and cancer were randomly assigned 1:1 to receive once-daily oral naldemedine 0.2 mg (n = 97) or placebo (n = 96) for 2 weeks, and those who continued on to COMPOSE-5 received naldemedine for 12 weeks (n = 131). Secondary assessments in COMPOSE-4 included the proportion of complete SBM (CSBM) responders, SBM or CSBM responders by week, and subjects with ≥1 SBM or CSBM within 24 h postinitial dose. Changes from baseline in the frequency of SBMs or CSBMs per week were assessed at weeks 1 and 2. Time to the first SBM or CSBM postinitial dose was also evaluated. In both studies, QOL impact was evaluated by Patient Assessment of Constipation-Symptoms (PAC-SYM) and PAC-QOL questionnaires. RESULTS Naldemedine improved bowel function for all secondary efficacy assessments versus placebo (all P ≤ 0.0002). The timely onset of naldemedine activity versus placebo was evidenced by median time to the first SBM (4.7 h versus 26.6 h) and CSBM (24.0 h versus 218.5 h) postinitial dose (all P < 0.0001). In COMPOSE-4, significant differences between groups were observed with the PAC-SYM stool domain (P = 0.045) and PAC-QOL dissatisfaction domain (P = 0.015). In COMPOSE-5, significant improvements from baseline were observed for overall and individual domain scores of PAC-SYM and PAC-QOL. CONCLUSIONS Naldemedine provided effective and timely symptomatic relief from OIC and improved the QOL of subjects with OIC and cancer. TRIAL REGISTRATION ID: www.ClinicalTrials.jp: JAPIC-CTI-132340 (COMPOSE-4) and JAPIC-CTI-132342 (COMPOSE-5).",2018,"RESULTS Naldemedine improved bowel function for all secondary efficacy assessments versus placebo (all P ≤ 0.0002).","['subjects with cancer', 'eligible adults with OIC and cancer', 'subjects with opioid-induced constipation and cancer']","['naldemedine 0.2\u2009mg (n = 97) or placebo', 'placebo', 'naldemedine', 'Naldemedine', 'ClinicalTrials.jp']","['proportion of complete SBM (CSBM) responders, SBM or CSBM responders', 'bowel function', 'quality of life of naldemedine', 'proportion of spontaneous bowel movement (SBM) responders', 'quality of life (QOL) assessments', 'PAC-QOL dissatisfaction domain', 'PAC-SYM stool domain', 'CSBM', 'Constipation-Symptoms (PAC-SYM) and PAC-QOL questionnaires', 'overall and individual domain scores of PAC-SYM and PAC-QOL', 'QOL impact']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3160897'}]","[{'cui': 'C4325237', 'cui_str': 'naldemedine 0.2 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0034380'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",131.0,0.0652521,"RESULTS Naldemedine improved bowel function for all secondary efficacy assessments versus placebo (all P ≤ 0.0002).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Kobe City Medical Center General Hospital, Kobe, Japan. Electronic address: nkatakami@kcho.jp.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Murata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Aichi Hospital, Okazaki, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Urology, Hitachi General Hospital, Hitachi, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yokota', 'Affiliation': 'Global Development, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arai', 'Affiliation': 'Global Development, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Global Development, Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Narabayashi', 'Affiliation': 'Department of Palliative Therapy, Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdy118'] 439,32253227,Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: the ELF cluster randomised controlled trial.,"OBJECTIVES The aim of this clustered, randomised controlled trial was to assess the effectiveness of a lumbopelvic postural feedback device for changing postural behaviour in a group of healthcare workers. We hypothesised that workers exposed to auditory postural feedback would reduce the number of times forward bending posture is adopted at work. METHODS This was a participant and assessor blinded, randomised, sham-controlled trial with blocked cluster random allocation. We recruited healthcare workers from aged care institutions. Healthcare sites were randomly allocated to the feedback or sham group (SG). A postural monitoring and feedback device was used to monitor and record lumbopelvic forward bending posture, and provided audio feedback whenever the user sustained lumbopelvic forward bending posture that exceeded predefined thresholds. The primary outcome measure was postural behaviour (exceeding thresholds). We used a robust variant of repeated measures mixed-effect model for assessing within-group and between-group differences in postural behaviour. RESULTS We recruited 19 sites, and 130 healthcare workers participated. There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group. CONCLUSIONS Findings from this trial indicate that audio feedback provided by a postural monitor device did not reduce the number of times healthcare workers exceeded the postural threshold. TRIAL REGISTRATION NUMBER ACTRN12616000449437.",2020,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group. ","['We recruited 19 sites, and 130 healthcare workers participated', 'healthcare workers from aged care institutions', 'Healthcare sites', 'a group of healthcare workers']","['feedback or sham group (SG', 'lumbopelvic monitor and feedback device', 'lumbopelvic postural feedback device']","['number of times postural threshold', 'postural behaviour (exceeding thresholds', 'number of times healthcare workers']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.253141,"There were no within-group changes on the number of times postural threshold was exceeded at 1-week follow-up (feedback group: -0.7, 95% CI -2.61 to 0.72; SG -0.3, -1.65 to 0.98), and no differences (0.05, 95% CI -1.83 to 1.94) between SG and feedback group. ","[{'ForeName': 'Daniel Cury', 'Initials': 'DC', 'LastName': 'Ribeiro', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand daniel.ribeiro@otago.ac.nz.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Milosavljevic', 'Affiliation': 'School of Physiotherapy, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Terry', 'Affiliation': 'School of Physiotherapy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Abbott', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106293'] 440,32178526,Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI).,"BACKGROUND The COMPASS trial (Cardiovascular Outcomes for People using Anticoagulation Strategies) demonstrated that dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily versus aspirin 100 mg once daily reduced the primary major adverse cardiovascular event (MACE) outcome of cardiovascular death, myocardial infarction, or stroke, as well as, mortality, in patients with chronic coronary syndromes or peripheral arterial disease. Whether this remains true in patients with a history of percutaneous coronary intervention (PCI) is unknown. METHODS In a prespecified subgroup analysis from COMPASS, we examined the outcomes of patients with chronic coronary syndrome with or without a previous PCI treated with DPI versus aspirin alone. Among patients with a previous PCI, we studied the effects of treatment according to the timing of the previous PCI. RESULTS Of the 27 395 patients in COMPASS, 16 560 patients with a chronic coronary syndrome were randomly assigned to DPI or aspirin, and, of these, 9862 (59.6%) had previous PCI (mean age 68.2±7.8, female 19.4%, diabetes mellitus 35.7%, previous myocardial infarction 74.8%, multivessel PCI 38.0%). Average time from PCI to randomization was 5.4 years (SD, 4.4) and follow-up was 1.98 (SD, 0.72) years. Regardless of previous PCI, DPI versus aspirin produced consistent reductions in MACE (PCI: 4.0% versus 5.5%; hazard ratio [HR], 0.74 [95% CI, 0.61-0.88]; no PCI: 4.4% versus 5.7%; HR, 0.76 [95% CI, 0.61-0.94], P -interaction=0.85) and mortality (PCI: 2.5% versus 3.5%; HR, 0.73 [95% CI, 0.58-0.92]; no PCI: 4.1% versus 5.0%; HR, 0.80 [95% CI, 0.64-1.00], P -interaction=0.59), but increased major bleeding (PCI: 3.3% versus 2.0%; HR, 1.72 [95% CI, 1.34-2.21]; no PCI: 2.9% versus 1.8%; HR, 1.58 [95% CI, 1.15-2.17], P -interaction=0.68). In those with previous PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since previous PCI (as early as 1 year and as far as 10 years; P -interaction=0.65), irrespective of having a previous myocardial infarction ( P -interaction=0.64). CONCLUSIONS DPI compared with aspirin produced consistent reductions in MACE and mortality but with increased major bleeding with or without previous PCI. Among those with previous PCI 1 year and beyond, the effects on MACE and mortality were consistent irrespective of time since last PCI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.",2020,"In those with prior PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since prior PCI (as early as 1 year and as far as 10 years) (p-interaction 0·65), irrespective of having a prior MI (p-interaction 0·64). ","['patients with chronic coronary syndromes or peripheral arterial disease', '27,395 patients in COMPASS, 16,560 chronic coronary syndrome patients', 'chronic coronary syndrome patients with or without a prior PCI treated with', 'patients with a history of percutaneous coronary intervention (PCI', 'patients with a prior PCI', 'Patients with Prior Percutaneous Coronary Intervention (COMPASS-PCI']","['aspirin', 'DPI or aspirin', 'Rivaroxaban Plus Aspirin Versus Aspirin', 'DPI versus aspirin alone', 'rivaroxaban']","['mortality', 'primary major adverse cardiovascular event (MACE) outcome of cardiovascular death, myocardial infarction (MI), or stroke as well as mortality', 'Cardiovascular OutcoMes', 'major bleeding', 'MACE and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1320647', 'cui_str': 'History of percutaneous coronary intervention (situation)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",16560.0,0.0797649,"In those with prior PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since prior PCI (as early as 1 year and as far as 10 years) (p-interaction 0·65), irrespective of having a prior MI (p-interaction 0·64). ","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Bainey', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (K.R.B., R.C.W.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (K.R.B., R.C.W.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Marsden', 'Affiliation': 'Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Department of Medicine, University of Edinburgh, UK (K.A.A.F.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, France (P.G.S.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, Bucharest, Romania (D.V.).'}, {'ForeName': 'Derek L', 'Initials': 'DL', 'LastName': 'Connolly', 'Affiliation': 'Birmingham City Hospital, UK (D.L.C.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer AG, Parsippany, NJ (S.D.B., J.M.F.).'}, {'ForeName': 'JoAnne M', 'Initials': 'JM', 'LastName': 'Foody', 'Affiliation': 'Bayer AG, Parsippany, NJ (S.D.B., J.M.F.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle (J.L.P., K.R.B.).'}, {'ForeName': 'Kelley R', 'Initials': 'KR', 'LastName': 'Branch', 'Affiliation': 'University of Washington, Seattle (J.L.P., K.R.B.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Wuppertal, Germany (E.M.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimsky', 'Affiliation': 'Charles University, Prague, Czech Republic (P.W.).'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044598'] 441,32162796,Effect of a Skills Training for Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment: A Randomized Clinical Trial.,"BACKGROUND Palliative systematic treatment offers uncertain and often limited benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). This trial examined the independent and combined effect of an oncologist training and a patient communication aid on SDM. METHODS In this multicenter randomized controlled trial with four parallel arms (2016-2018), oncologists (n = 31) were randomized to receive SDM communication skills training or not. The training consisted of a reader, two group sessions, a booster session, and a consultation room tool (10 hours). Patients (n = 194) with advanced cancer were randomized to receive a patient communication aid or not. The aid consisted of education on SDM, a question prompt list, and a value clarification exercise. The primary outcome was observed SDM as rated by blinded observers from audio-recorded consultations. Secondary outcomes included patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made. RESULTS The oncologist training had a large positive effect on observed SDM (Cohen's d = 1.12) and on patient-reported SDM (d = 0.73). The patient communication aid did not improve SDM. The combination of interventions did not add to the effect of training oncologists only. The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made. CONCLUSION Training medical oncologists in SDM about palliative systemic treatment improves both observed and patient-reported SDM. A patient communication aid does not. The incorporation of skills training in (continuing) educational programs for medical oncologists is likely to stimulate the widely advocated uptake of shared decision making in clinical practice. TRIAL REGISTRATION Netherlands Trial Registry NTR 5489. IMPLICATIONS FOR PRACTICE Treatment for advanced cancer offers uncertain and often small benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). SDM is increasingly advocated for ethical reasons and for its beneficial effect on patient outcomes. Few initiatives to stimulate SDM are evaluated in robust designs. This randomized controlled trial shows that training medical oncologists improves both observed and patient-reported SDM in clinical encounters (n = 194). A preconsultation communication aid for patients did not add to the effect of training oncologists. SDM training effectively changes oncologists' practice and should be implemented in (continuing) educational programs.",2020,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made. ","['four parallel arms (2016-2018), oncologists (n =\u200931', 'Patients (n =\u2009194) with advanced cancer', 'Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment']","['SDM communication skills training or not', 'oncologist training', 'patient communication aid or not', 'SDM', 'Skills Training', 'SDM training']","['decisional conflict, quality of life, consultation duration, or the decision made', 'SDM', 'observed SDM', ""patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made""]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.162469,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made. ","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Henselmans', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pomme', 'Initials': 'P', 'LastName': 'van Maarschalkerweerd', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke C J M', 'Initials': 'HCJM', 'LastName': 'de Haes', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helle-Brit', 'Initials': 'HB', 'LastName': 'Fiebrich', 'Affiliation': 'Department of Medical Oncology, Isalaklinieken, Zwolle, The Netherlands.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Dohmen', 'Affiliation': 'Department of Medical Oncology, BovenIJZiekenhuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharinaziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Filip Y F L', 'Initials': 'FYFL', 'LastName': 'de Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ellen M A', 'Initials': 'EMA', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0453'] 442,32162804,The McCAVE Trial: Vanucizumab plus mFOLFOX-6 Versus Bevacizumab plus mFOLFOX-6 in Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC).,"BACKGROUND Bevacizumab, a VEGF-A inhibitor, in combination with chemotherapy, has proven to increase progression-free survival (PFS) and overall survival in multiple lines of therapy of metastatic colorectal cancer (mCRC). The angiogenic factor angiopoetin-2 (Ang-2) is associated with poor prognosis in many cancers, including mCRC. Preclinical models demonstrate improved activity when inhibiting both VEGF-A and Ang-2, suggesting that the dual VEGF-A and Ang-2 blocker vanucizumab (RO5520985 or RG-7221) may improve clinical outcomes. This phase II trial evaluated the efficacy of vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin) versus bevacizumab/mFOLFOX-6 for first-line mCRC. PATIENTS AND METHODS All patients received mFOLFOX-6 and were randomized 1:1 to also receive vanucizumab 2,000 mg or bevacizumab 5 mg/kg every other week. Oxaliplatin was given for eight cycles; other agents were continued until disease progression or unacceptable toxicity for a maximum of 24 months. The primary endpoint was investigator-assessed PFS. RESULTS One hundred eighty-nine patients were randomized (vanucizumab, n = 94; bevacizumab, n = 95). The number of PFS events was comparable (vanucizumab, n = 39; bevacizumab, n = 43). The hazard ratio was 1.00 (95% confidence interval, 0.64-1.58; p = .98) in a stratified analysis based on number of metastatic sites and region. Objective response rate was 52.1% and 57.9% in the vanucizumab and bevacizumab arm, respectively. Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab. The incidence of adverse events of grade ≥3 was similar between treatment arms (83.9% vs. 82.1%); gastrointestinal perforations (10.8% vs. 8.4%) exceeded previously reported rates in this setting. Hypertension and peripheral edema were more frequent in the vanucizumab arm. CONCLUSION Vanucizumab/mFOLFOX-6 did not improve PFS and was associated with increased rates of antiangiogenic toxicity compared with bevacizumab/mFOLFOX-6. Our results suggest that Ang-2 is not a relevant therapeutic target in first-line mCRC. IMPLICATIONS FOR PRACTICE This randomized phase II study demonstrates that additional angiopoietin-2 (Ang-2) inhibition does not result in superior benefit over anti-VEGF-A blockade alone when each added to standard chemotherapy. Moreover, the performed pharmacokinetic and pharmacodynamic analysis revealed that vanucizumab was bioavailable and affected its intended target, thereby strongly suggesting that Ang-2 is not a relevant therapeutic target in the clinical setting of treatment-naïve metastatic colorectal cancer. As a result, the further clinical development of the dual VEGF-A and Ang-2 inhibitor vanucizumab was discontinued.",2020,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"['One hundred eighty-nine patients', 'Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC', 'All patients received mFOLFOX-6']","['vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin', 'vanucizumab 2,000 mg or bevacizumab', 'Oxaliplatin', 'vanucizumab and bevacizumab', 'Bevacizumab', 'Bevacizumab plus mFOLFOX-6', 'bevacizumab', 'bevacizumab/mFOLFOX-6', 'Vanucizumab plus mFOLFOX-6']","['hazard ratio', 'rates of antiangiogenic toxicity', 'incidence of adverse events of grade ≥3', 'number of PFS events', 'investigator-assessed PFS', 'Hypertension and peripheral edema', 'progression-free survival (PFS) and overall survival', 'PFS', 'gastrointestinal perforations', 'Objective response rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}]","[{'cui': 'C4331496', 'cui_str': 'vanucizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",189.0,0.110282,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"[{'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sauri', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Antonio Cubillo', 'Initials': 'AC', 'LastName': 'Gracián', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-López', 'Affiliation': 'Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Alfonso', 'Affiliation': 'Hospital Universitario Gregorio Maranon, Madrid, Spain.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Florida Cancer Specialists, Leesburg, Florida, USA.'}, {'ForeName': 'Maria-Luisa Limon', 'Initials': 'ML', 'LastName': 'Miron', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Biomedical Research Institute, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Cristina Santos', 'Initials': 'CS', 'LastName': 'Vivas', 'Affiliation': ""Institut Català d'Oncologia and L'Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bessudo', 'Affiliation': 'California Cancer Associates for Research and Excellence, San Diego, California, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Plezia', 'Affiliation': 'Arizona Clinical Research Center, Tucson, Arizona, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Moons', 'Affiliation': 'Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Andel', 'Affiliation': 'County Hospital Steyr, Steyr, Austria.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancerologie de l'Ouest, Saint Herblain, France.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'van der Westhuizen', 'Affiliation': 'Calvary Mater Hospital, Newcastle, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rossomanno', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boetsch', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Lahr', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Izolda', 'Initials': 'I', 'LastName': 'Franjkovic', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Heil', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Krieter', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hurwitz', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0291'] 443,32170802,Anodal transcranial direct current stimulation over the primary motor cortex attenuates capsaicin-induced dynamic mechanical allodynia and mechanical pain sensitivity in humans.,"BACKGROUND Anodal transcranial direct current stimulation over the primary cortex has been shown to activate regions of the brain involved in the descending modulation of pain sensitivity. However, more research is required to dissect the spinal cord analgesic mechanisms associated with the development of central sensitization. METHODS In this randomized, double blind, crossover study 12 healthy participants had baseline mechanical stimulus response (S/R) functions measured before and after the development of capsaicin-induced ongoing pain sensitivity. The effects of 20 min of either real or sham transcranial direct current stimulation (tDCS, 2 mA) over the primary motor cortex on dynamic mechanical allodynia (DMA) and mechanical pain sensitivity (MPS) were then investigated. RESULTS Topical application of capsaicin resulted in an increase in area under the pain ratings curve for both DMA (p < .01) and MPS (p < .01). The effects of tDCS on the area under the curve ratio (i.e. post-/pre-treatment) revealed significant analgesic effects over DMA (p < .05) and MPS (p < .05) when compared with sham. CONCLUSIONS This study demonstrates that anodal tDCS over the primary motor cortex can reduce both dynamic and static forms of mechanical pain sensitivity associated with the development of DMA and MPS, respectively. The use of tDCS may provide a novel mechanism-driven therapy in chronic pain patients with altered mechanical S/R functions. SIGNIFICANCE This research shows new evidence that anodal tDCS over the primary motor cortex can reduce dynamic and static forms of mechanical pain sensitivity in the capsaicin model of ongoing pain. By using this approach, it may be possible to provide mechanism-driven analgesia in chronic pain patients who have dynamic mechanical allodynia and/or secondary mechanical hyperalgesia.",2020,"RESULTS Topical application of capsaicin resulted in an increase in area under the pain ratings curve for both DMA (p < .01) and MPS (p < .01).","['12 healthy participants had', 'humans', 'chronic pain patients with altered mechanical S/R functions']","['tDCS', 'capsaicin', 'Anodal transcranial direct current stimulation', 'anodal tDCS', '20\xa0min of either real or sham transcranial direct current stimulation (tDCS, 2\xa0mA']","['dynamic mechanical allodynia (DMA) and mechanical pain sensitivity (MPS', 'area under the pain ratings curve', 'baseline mechanical stimulus response (S/R) functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C2936719', 'cui_str': 'Mechanical Allodynia'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",12.0,0.241756,"RESULTS Topical application of capsaicin resulted in an increase in area under the pain ratings curve for both DMA (p < .01) and MPS (p < .01).","[{'ForeName': 'Sam W', 'Initials': 'SW', 'LastName': 'Hughes', 'Affiliation': 'The Nick Davey Laboratory, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ward', 'Affiliation': 'The Nick Davey Laboratory, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Strutton', 'Affiliation': 'The Nick Davey Laboratory, Faculty of Medicine, Imperial College London, London, UK.'}]","European journal of pain (London, England)",['10.1002/ejp.1557'] 444,31455099,Self-reported emotional eating is not related to greater food intake: results from two laboratory studies.,"Objective : Despite widespread use of emotional eating self-report measures, the validity of these measures has been questioned. Most of this research has focused on the validity of the Dutch Eating Behavior Questionnaire (DEBQ) as opposed to the Emotional Eating Scale (EES). The current paper describes two experimental studies that examined associations between self-reported emotional eating and emotional eating measured in the laboratory. To address previous design limitations, the current studies used highly palatable foods, effective mood induction methods, and the EES, in addition to the DEBQ. Design : In two samples of college students, participants were randomised to a neutral or negative mood induction. Main Outcome Measures : The traditional DEBQ and the original and revised versions of the EES were used to measure self-reported emotional eating. Emotional eating was assessed in the laboratory using a bogus taste test. Subjects were asked to taste various foods, and food intake was measured. Results : In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test). Conclusion : Future research in this area would benefit from using diverse samples and development of novel methods of assessing emotional eating.",2020,"In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test). ",['two samples of college students'],['neutral or negative mood induction'],"['Emotional eating', 'emotional eating and emotional eating', 'Dutch Eating Behavior Questionnaire (DEBQ']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0329618,"In both samples, self-reported emotional eating using the DEBQ and EES was unrelated to laboratory measured emotional eating (i.e. food consumed during the bogus taste test). ","[{'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Braden', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Emley', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Watford', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'LaNaya', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Musher-Eizenman', 'Affiliation': 'Bowling Green State University, Bowling Green, OH, USA.'}]",Psychology & health,['10.1080/08870446.2019.1649406'] 445,32067625,Propranolol Reduces Portal Vein Diameter in Schistosomal Liver Disease with Portal Hypertension: A Prospective Cohort Study.,"Hepatosplenic schistosomiasis (HSS) complicates portal hypertension, leading to life-threatening variceal bleeding. Variceal bleeding is associated with increased portal vein diameter (PVD). Beta-blockers prevent variceal bleeding. It is unclear whether beta-blockers such as propranolol can reduce PVD in HSS. We aimed to explore the effect of propranolol on PVD in HSS. A longitudinal study was conducted at the University Teaching Hospital, Zambia, as an extension of a clinical trial of rifaximin undertaken to test the hypothesis that rifaximin could reduce bacterial translocation in HSS. We randomized 85 adults to either rifaximin and standard care, or propranolol-based standard care only for 42 days. We then followed up all the patients on propranolol up to day 180. We used ultrasound to measure PVD at baseline and day 180. The primary outcome was reduction in PVD. Beta-blockade and splenic size reduction were secondary outcomes. Portal vein diameter reduced after 180 days of propranolol therapy from median 12 mm (interquartile range (IQR): 11-14) to median 10 mm (IQR: 9-13) ( P < 0.001). The pulse rate reduced from baseline median 70 beats/minute (IQR: 66-80) to 65 beats/minute (IQR: 60-70) by day 180 ( P = 0.006). Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001). Splenic size remained unchanged. Propranolol led to the reduction in PVD over 180 days. This suggests that ultrasound could be useful in monitoring response and compliance to beta-blockers, especially in resource-constraint areas where portal hypertension measurement facilities are unavailable.",2020,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"['Schistosomal Liver with Portal Hypertension', '85 adults to either']","['Propranolol', 'rifaximin and standard care, or propranolol-based standard care', 'Beta-blockers', 'propranolol']","['reduction in PVD', 'Portal vein diameter', 'Hemoglobin levels', 'Beta-blockade and splenic size reduction', 'portal vein diameter (PVD', 'Splenic size', 'variceal bleeding', 'Variceal bleeding', 'Portal Vein Diameter', 'pulse rate']","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}]",85.0,0.142688,Hemoglobin levels improved from baseline median 8 g/dL (IQR: 6-11) to 12 g/dL (10-14) ( P < 0.001).,"[{'ForeName': 'Edford', 'Initials': 'E', 'LastName': 'Sinkala', 'Affiliation': 'Department of Internal Medicine, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vinikoor', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kanekwa', 'Initials': 'K', 'LastName': 'Zyambo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Besa', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bright', 'Initials': 'B', 'LastName': 'Nsokolo', 'Affiliation': 'Department of Internal Medicine, Tropical Gastroenterology and Nutritional Group, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine, Queen Mary University of London, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0452'] 446,31621423,A theory-based intervention delivered by an online social media platform to promote oral health among Iranian adolescents: a cluster randomized controlled trial.,"Objective: Based on the Health Action Process Approach, we tested the efficacy of a theory-based program using an online social media platform (Telegram) to promote good oral hygiene behaviour among Iranian adolescents. Design: A three-arm randomized-controlled trial design was used, consisting of an adolescent only intervention group (A group; n  = 253), an adolescent and mother intervention group (A + M group; n  = 260), and a control group ( n  = 278). Main outcome measures: Psychosocial variables, toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index. Results: Increases in adolescent toothbrushing at the one- and six-month follow-ups in both intervention groups compared to the control group were observed. Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group. Improvements to toothbrushing social cognitions were also observed. Conclusions : Current results support the use of the theory-based program delivered by Telegram in improving good oral hygiene behaviour and oral health outcomes among Iranian adolescents. Involving mothers in an intervention can confer additional benefits for adolescent oral health.",2020,"Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group.",['Iranian adolescents'],"['adolescent and mother intervention group (A\u2009+\u2009M group; n \u2009=\u2009260), and a control group', 'theory-based program using an online social media platform (Telegram', 'online social media platform']","['toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores', 'good oral hygiene behaviour and oral health outcomes', 'toothbrushing social cognitions', 'Psychosocial variables, toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]","[{'cui': 'C0040461', 'cui_str': 'Toothbrushing'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031092', 'cui_str': 'Periodontal Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene (finding)'}, {'cui': 'C0029162'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",278.0,0.0287629,"Adolescents in the A + M group showed significant greater improvements in their toothbrushing behaviour, Visual Plaque Index, and Community Periodontal Index scores than adolescents in the A group.","[{'ForeName': 'Janneke Francisca Maria', 'Initials': 'JFM', 'LastName': 'Scheerman', 'Affiliation': 'Department Oral Hygiene, Inholland University of Applied Sciences, Cluster Health, Sport and Welfare, Amsterdam, The Netherlands.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Mohammad Owaise', 'Initials': 'MO', 'LastName': 'Sharif', 'Affiliation': 'Eastman Dental Institute, University College London, London, England.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Lindmark', 'Affiliation': 'Department of Natural Science and Biomedicine, Centre for Oral Health, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Psychology & health,['10.1080/08870446.2019.1673895'] 447,31356535,Effects of Pre-Cardiopulmonary Bypass Administration of Dexmedetomidine on Cardiac Injuries and the Inflammatory Response in Valve Replacement Surgery With a Sevoflurane Postconditioning Protocol: A Pilot Study.,"BACKGROUND Preventing myocardial ischemia-reperfusion injury in on-pump cardiac surgeries remains an enormous challenge. Sevoflurane postconditioning has been effective at overcoming this challenge by modulating inflammatory mediators and ameliorating antioxidative stress. Dexmedetomidine (DEX) is a commonly used medication for cardiac patients with organ-protective properties that lead to positive outcomes. Whether DEX also has cardiac-protective properties and the associated mechanism in sevoflurane postconditioning-based valve replacement surgeries are unknown. OBJECTIVE This study was conducted to observe the effect of DEX administration before cardiopulmonary bypass (CPB) on myocardial injury, oxidative stress, and inflammatory response indicators in the peripheral blood. METHODS Twenty-eight eligible cardiac patients who underwent valve replacement surgery with standard sevoflurane postconditioning were included in the study. The patients were randomly divided into a DEX group and a non-DEX group according to whether DEX (0.5-µg/kg overload dose for 10 minutes and a 0.5-μg/kg/h maintenance dose) or saline was administered from induction to the beginning of CPB. The primary outcome was the cardiac troponin I concentration (cTnI) in the blood 24 hours after CPB. The levels of malondialdehyde (MDA), superoxide dismutase, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8) were also measured. RESULTS The mean cTnI at 24 hours after CPB was clearly decreased in the DEX group compared with that in the non-DEX group (4.16 ± 1.58 vs. 6.90 ± 3.73, P < 0.05). TNF-α levels were lower in the DEX group after CPB (T1-T5), with a significant difference found at 1-6 hours after CPB (1 hour, 19.03 vs. 28.09; 6 hours, 20.74 vs. 30.94, P < 0.05). The IL-6 and IL-8 concentrations in the DEX group were dramatically increased at 6 hours after CPB (P < 0.05). The MDA content and superoxide dismutase activity were comparable between the 2 groups. A lower proportion of anemia cases were noted after CPB in the DEX group than in the non-DEX group (non-DEX, 10% vs. DEX, 5%, P < 0.05). CONCLUSIONS In valve replacement surgery with sevoflurane postconditioning, pre-CPB administration of DEX can reduce the cTnI level at 24 hours after CPB and brings synergic benefits of the inflammatory response.",2019,"The levels of malondialdehyde (MDA), superoxide dismutase, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8) were also measured. ","['Twenty-eight eligible cardiac patients who underwent valve replacement surgery with standard sevoflurane postconditioning were included in the study', 'Valve Replacement Surgery With a Sevoflurane Postconditioning Protocol', 'cardiac patients with organ-protective properties']","['DEX group and a non-DEX', 'DEX', 'DEX administration before cardiopulmonary bypass (CPB', 'Dexmedetomidine (DEX', 'Sevoflurane postconditioning', 'saline', 'Dexmedetomidine', 'sevoflurane']","['Cardiac Injuries and the Inflammatory Response', 'MDA content and superoxide dismutase activity', 'mean cTnI', 'levels of malondialdehyde (MDA), superoxide dismutase, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8', 'cTnI level', 'cardiac troponin I concentration (cTnI) in the blood 24 hours after CPB', 'IL-6 and IL-8 concentrations', 'myocardial injury, oxidative stress, and inflammatory response indicators', 'TNF-α levels', 'proportion of anemia cases']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005768'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",28.0,0.086548,"The levels of malondialdehyde (MDA), superoxide dismutase, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8) were also measured. ","[{'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the Second Affiliated Hospital of Jiaxing University, Jiaxing City, China.'}, {'ForeName': 'Dongna', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ''}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000698'] 448,30256491,White matter tract microstructure of the mPFC-amygdala predicts interindividual differences in placebo response related to treatment in migraine patients.,"To investigate whether interindividual variability of white matter (WM) tract microstructure of the medial prefrontal cortex (mPFC)-amygdala circuit could predict 8-week placebo treatment outcomes in patients with migraine without aura (MO) using diffusion tensor imaging (DTI) with a tractography atlas-based analysis algorithm and a linear support vector machine algorithm. This study received institutional review board approval, and all subjects gave informed consent. One hundred and twenty-four MO had an 8-week sham acupuncture treatment. Patients were subdivided into recovering (MOr, >50% improvement in migraine attack frequency after treatment) and persisting (MOp, <50% reduction in number of migraine days). Neuroimaging was collected via magnetic resonance imaging (MRI) in all subjects. Patients were imaged during the interictal phase of migraine (at least 72 hr after, and not within 24 hr of a migraine) before the treatment. WM microstructures were quantified along the selected fiber pathway and were used to evaluate the discrimination performance for classifying MOr and MOp. The combined features of diffusion measures from vertices along the pathways of the mPFC-amygdala accurately discriminated MOr from MOp migraineurs with an accuracy of 84.0% (p < .005, permutation test). The most discriminative WM features that contributed to the classification were located in the external capsule and ACC/mPFC. Our findings suggested that the variability of placebo treatment outcomes in migraineurs could be predicted from priori diffusion measures along the fiber pathways of the mPFC-amygdala, which may demonstrate a potential of WM neuroimaging features as imaging markers for identifying placebo responders in migraine patients.",2019,"The combined features of diffusion measures from vertices along the pathways of the mPFC-amygdala accurately discriminated MOr from MOp migraineurs with an accuracy of 84.0% (p < .005, permutation test).","['patients with migraine without aura (MO) using', 'migraine patients', 'One hundred and twenty-four MO']","['white matter (WM) tract microstructure of the medial prefrontal cortex (mPFC)-amygdala circuit', 'diffusion tensor imaging (DTI) with a tractography atlas-based analysis algorithm and a linear support vector machine algorithm', 'placebo']",['migraine attack frequency'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0682708'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0002045'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0458942,"The combined features of diffusion measures from vertices along the pathways of the mPFC-amygdala accurately discriminated MOr from MOp migraineurs with an accuracy of 84.0% (p < .005, permutation test).","[{'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Peoples Republic of China.""}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Peoples Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Peoples Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Imaging, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Peoples Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Peoples Republic of China.""}]",Human brain mapping,['10.1002/hbm.24372'] 449,31607172,Editor's choice: Optimizing healthy food preferences by serious gaming.,"Objective: Serious gaming is an upcoming and promising tool in prevention and health promotion. The aim of this experimental study was to examine whether health-related serious gaming could optimize food-related outcomes and physical activity. Design: Eighty-one healthy participants (80% female) were randomly allocated to an experimental condition, in which participants played serious games based on transferring information, priming and evaluative conditioning, for half an hour, or a control condition, in which participants played non-health-related computer games. Main outcome measures: The primary study outcome was self-reported food preference and self-reported food choice, assessed by the Food Choice Task with food pairs differing in healthiness, or in both healthiness and attractiveness. Secondary outcomes were actual food choice and physical activity. Results: A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition. No significant differences were found on the other outcomes. Conclusions: This study provides preliminary support for the effects of serious gaming based on optimizing food preferences. More research is needed to confirm the present findings and to further elucidate and optimize the effects of serious gaming on health behaviours.",2020,A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition.,['Eighty-one healthy participants (80% female'],"['participants played serious games based on transferring information, priming and evaluative conditioning, for half an hour, or a control condition, in which participants played non-health-related computer games']","['self-reported food preference and self-reported food choice, assessed by the Food Choice Task with food pairs differing in healthiness, or in both healthiness and attractiveness', 'actual food choice and physical activity']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",81.0,0.0314779,A significantly healthier food preference for pairs differing in healthiness was found on the Food Choice Task in the experimental compared to the control condition.,"[{'ForeName': 'Lemmy', 'Initials': 'L', 'LastName': 'Schakel', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Manai', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Sylvia van', 'Initials': 'SV', 'LastName': 'Beugen', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Rosalie van der', 'Initials': 'RV', 'LastName': 'Vaart', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Henriët van', 'Initials': 'HV', 'LastName': 'Middendorp', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, Leiden, The Netherlands.'}]",Psychology & health,['10.1080/08870446.2019.1675657'] 450,30152573,Oxytocin enhances the pain-relieving effects of social support in romantic couples.,"Social support plays a vital role in physical and mental well-being. The neuropeptide hormone oxytocin (OXT) has been implicated in modulating pair-bonding and affiliative behaviors, but whether OXT contributes to the analgesic effects of a romantic partner's touch remains elusive. In the present randomized placebo-controlled, between-group, functional magnetic resonance imaging study involving 194 healthy volunteers (97 heterosexual couples), we tested the effects of intranasal OXT (24 IU) on handholding as a common mode of expressing emotional support in romantic couples. We scanned the subjects while brief electric shocks were administered. The subjects assumed that they received social support from either their romantic partner or an unfamiliar person. Unbeknown to the subject, in the partner and stranger support conditions, the same male experimenter always held the subject's left hand. Partner support was most effective in reducing the unpleasantness of electric shocks, and OXT further attenuated the unpleasantness across conditions. On the neural level, OXT significantly augmented the beneficial effects of partner support, as evidenced by a stronger decrease of neural responses to shocks in the anterior insula (AI), a stronger activity increase in the middle frontal gyrus (MFG), and a strengthened functional coupling between the AI and MFG. Our results support the notion that OXT specifically modulates the beneficial effects of social support in romantic couples by concomitantly reducing pain-associated activity and increasing activity linked to cognitive control and pain inhibition. We hypothesize that impaired OXT signaling may contribute to the experience of a lack of partner support.",2019,"Partner support was most effective in reducing the unpleasantness of electric shocks, and OXT further attenuated the unpleasantness across conditions.","['194 healthy volunteers (97 heterosexual couples', 'romantic couples']","['social support from either their romantic partner or an unfamiliar person', 'placebo', 'neuropeptide hormone oxytocin (OXT', 'intranasal OXT', 'Oxytocin', 'OXT']","['unpleasantness of electric shocks', 'neural responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0037438'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue (event)'}]",194.0,0.0221537,"Partner support was most effective in reducing the unpleasantness of electric shocks, and OXT further attenuated the unpleasantness across conditions.","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wassermann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wollseifer', 'Affiliation': 'Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Ditzen', 'Affiliation': 'Center for Psychosocial Medicine, Institute of Medical Psychology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Center for Psychosocial Medicine, Institute of Medical Psychology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Department of Clinical Chemistry and Clinical Pharmacology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, Giessen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, Bonn, Germany.'}]",Human brain mapping,['10.1002/hbm.24368'] 451,32249441,The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial.,"AIM To assess the outcomes of platelet-rich plasma as a scaffold in regenerative/revitalization endodontics (RET) using cone beam computed tomography (CBCT) and 2-dimensional radiographs. METHODOLOGY Twenty-six healthy patients with mean age of 12.66 ± 4.47, and immature permanent anterior teeth with necrotic pulps, were randomly allocated to two groups, whereby RET was performed using platelet-rich plasma (PRP, test group) and blood clot (BLC, control group). Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW) and radiographic root area (RRA), were assessed using both radiographic methods, whilst changes in periapical area diameter (PAD) were assessed using CBCT, over a period of 12 months. T-test and chi-square/Fisher's exact tests were used to compare continuous and categorical data between BLC and PRP groups, respectively. Changes in RL, RDT, AFW, RRA and PAD were examined by comparing the two groups (PRP versus BLC) using multilevel modelling, considering the clustering effect of repeated measures of several teeth originating from the same participant. RESULTS Changes in RL, RDT, AFW, RRA and PAD, over time, were found to be significant for both groups. There was, however, no difference between the RET techniques (PRP versus BLC), using both radiographic and CBCT methods. The results of both assessment techniques (CBCT and 2-dimensional radiographic methods) were highly consistent (overall ICC ranged between 0.80 and 0.94). In addition, a significant effect of baseline PAD was found on RL, RRA and AD at 12 months (RL effect = -0.68, P < 0.001; RRA effect = -1.91, P = 0.025; AD effect = 0.08, P = 0.024). CONCLUSION The current study highlights successful and comparable clinical and radiographic outcomes of RET techniques using PRP and BLC. Standardized and calibrated 2-dimensional radiographic assessment was as effective as CBCT in assessing RET outcomes; therefore, the routine use of CBCT in RET is not recommended. Although an effect of baseline periapical lesion diameter on root development outcomes, at 12 months, were observed, more studies are recommended in order to assess such an effect.",2020,"Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA), were assessed using both radiographic methods, while changes in periapical area diameter (PAD) was assessed using CBCT, over a period of 12 months.","['immature permanent anterior teeth with necrotic pulps', 'Twenty-six healthy patients with mean age of 12.66']","['Cone Beam Computed Tomography (CBCT', 'platelet rich plasma (PRP, test group) and blood clot (BLC, control group', 'platelet-rich plasma']","['RL, RDT, AFW, RRA and PAD', 'baseline PAD', 'Changes in RL, RDT, AFW, RRA, and PAD', 'periapical area diameter (PAD', 'Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0034596', 'cui_str': 'Radioreceptor assay'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0524789', 'cui_str': 'Structure of apical foramen of tooth'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",26.0,0.0509993,"Changes in root length (RL), root dentinal thickness (RDT), apical foramen width (AFW), and radiographic root area (RRA), were assessed using both radiographic methods, while changes in periapical area diameter (PAD) was assessed using CBCT, over a period of 12 months.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'ElSheshtawy', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nazzal', 'Affiliation': 'Paediatric Dentistry Section, Hamad Dental Center, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'O I', 'Initials': 'OI', 'LastName': 'El Shahawy', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'El Baz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Ismail', 'Affiliation': 'Department of Endodontics, The National Research Center, Cairo, Egypt.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Oral Biology, School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Ezzat', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",International endodontic journal,['10.1111/iej.13303'] 452,32247522,Effect of Ketamine Added to Ropivacaine in Nerve Block for Postoperative Pain Management in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Trial.,"PURPOSE Nerve blocks are commonly used as a part of multimodal pain relief. It was previously shown that ketamine could enhance the analgesic effect of local anesthetics in nerve blocks. A literature review on adding ketamine to local anesthetics for ameliorating analgesia revealed inconsistencies in analgesic efficiency and safety. This prospective, randomized, double-blind trial was performed to evaluate the antinociceptive effect of mixing ketamine with local anesthetics in a combined femoral and sciatic nerve block (CFSNB) during anterior cruciate ligament (ACL) reconstruction. METHODS Seventy-six patients undergoing preoperative ultrasound-guided CFSNB in ACL reconstruction were enrolled. Patients were randomly assigned to 3 groups: Group RNK received perineural administration of 40-mg ketamine plus 0.375% ropivacaine in 40-mL volume; Group RIK received 40 mL of 0.375% ropivacaine, as well as IV ketamine 40 mg; and Group R received 40 mL of 0.375% ropivacaine. Pain scores were recorded. AUC was calculated based on the pain scores at different times. Duration of CFSNB, postoperative analgesic demand, time to first analgesic demand, and adverse events were also examined. FINDINGS Perineural ketamine decreased pain scores 20 and 24 h' postoperatively, as well as lowered AUC values (all, P = 0.001). Group RNK had a prolonged time to first analgesic request (P = 0.014), inhibited rebound pain (P = 0.001), and increased satisfactory score at 48 h' postsurgery (P = 0.001). Perineural ketamine prolonged the duration of sensory block (P = 0.001) with no effect on early mobilization. There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585). Compared with the 2 other groups, IV ketamine had a higher incidence of hallucination after operations. IMPLICATIONS Perineural ketamine added to the ropivacaine-enhanced analgesic efficacy of CFSNB with less rebound pain compared with the IV ketamine and control groups. IV ketamine had no effect in potentiating analgesia when a conventional multimodal approach was used in the study. Chinese Clinical Trial Registry: ChiCTR1900023867.",2020,"There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585).","['Seventy-six patients undergoing preoperative ultrasound-guided CFSNB in ACL reconstruction were enrolled', 'anterior cruciate ligament (ACL) reconstruction', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction']","['Ropivacaine', 'ketamine', 'mixing ketamine with local anesthetics', 'perineural administration of 40-mg ketamine plus 0.375% ropivacaine in 40-mL volume; Group RIK received 40\xa0mL of 0.375% ropivacaine', 'ketamine 40\xa0mg; and Group R received 40\xa0mL of 0.375% ropivacaine', 'ropivacaine', 'CFSNB', 'Ketamine']","['inhibited rebound pain', 'Duration of CFSNB, postoperative analgesic demand, time to first analgesic demand, and adverse events', 'analgesic efficiency and safety', 'Pain scores', 'satisfactory score', 'postoperative pain scores, AUC of different time intervals', 'analgesic efficacy', 'Postoperative Pain Management', 'lowered AUC values', 'antinociceptive effect', 'prolonged time to first analgesic request', 'pain scores', 'time to first rescue analgesics', 'potentiating analgesia', 'duration of sensory block']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441852', 'cui_str': 'Group R'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",76.0,0.126864,"There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585).","[{'ForeName': 'Tianqi', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ximou', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Wendong', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jiehao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China. Electronic address: sun_jiehao@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.004'] 453,31192355,Long-course preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study.,"BACKGROUND This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications. PATIENTS AND METHODS Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin). RESULTS Patients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively. CONCLUSION The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated. CLINICAL TRIAL NUMBER The trial is registered as ClinicalTrials.gov number NCT00833131.",2019,"The difference in OS was insignificant, HR = 0.90","['515 patients were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group', 'Patients with cT4 or fixed cT3 rectal cancer', 'rectal cancers with clinical (c)T4 or fixed cT3']","['preoperative short-course radiotherapy and consolidation chemotherapy (CCT', 'preoperative 5 × 5\u2009Gy and three cycles of FOLFOX4 or to chemoradiation (50.4\u2009Gy with bolus 5-Fu, leucovorin and oxaliplatin', 'Long-course preoperative chemoradiation vs. 5 x 5\u2009Gy and consolidation chemotherapy']","['acute toxicity of preoperative treatment and better overall survival (OS', 'OS', 'disease-free survival', 'cumulative incidences of local failure and distant metastases', 'rate of late complications', 'radical surgery rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",515.0,0.184679,"The difference in OS was insignificant, HR = 0.90","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ciseł', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pietrzak', 'Affiliation': 'II Department of Radiotherapy.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Michalski', 'Affiliation': 'Bioinformatics and Biostatistics Unit.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wyrwicz', 'Affiliation': 'Departments of Clinical Oncology.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rutkowski', 'Affiliation': 'Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kosakowska', 'Affiliation': 'Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cencelewicz', 'Affiliation': 'Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spałek', 'Affiliation': 'II Department of Radiotherapy.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jankiewicz', 'Affiliation': ""Department of Surgical Oncology, Medical University of Lublin, Lublin; Department of Radiotherapy, St. John's Cancer Center, Lublin.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Styliński', 'Affiliation': '1st Department of General Surgery, Transplantology and Nutritional Therapy Medical University of Lublin.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bębenek', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kapturkiewicz', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maciejczyk', 'Affiliation': 'Radiotherapy, Silesian Oncological Centre, Wrocław.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sadowski', 'Affiliation': 'Department of Radiotherapy, Regional Oncological Centre, Kielce.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zygulska', 'Affiliation': 'Department of Radiotherapy, Beskid Centre of Oncology, Bielsko-Biala.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zegarski', 'Affiliation': 'Departments of Oncological Surgery.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jankowski', 'Affiliation': 'Departments of Oncological Surgery.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Las-Jankowska', 'Affiliation': 'Clinical Oncology, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Toczko', 'Affiliation': 'Department of Surgery, Regional Hospital, Elblag.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Żelazowska-Omiotek', 'Affiliation': 'Department of Radiotherapy, Regional Cancer Centre, Tarnów.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kępka', 'Affiliation': 'Department of Radiotherapy, Military Institute of Medicine, Warsaw.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Socha', 'Affiliation': 'Department of Radiotherapy, Military Institute of Medicine, Warsaw; Department of Radiotherapy, Regional Oncology Center, Czestochowa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wasilewska-Tesluk', 'Affiliation': 'Radiotherapy Department, Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn; Department of Oncology, University of Warmia and Mazury, Olsztyn.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Markiewicz', 'Affiliation': 'Department of Surgery, Regional Cancer Centre, Białystok.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kładny', 'Affiliation': 'Department of General Surgery and Surgical Oncology First Clinical Hospital of Pomeranian Medical University, Szczecin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majewski', 'Affiliation': 'Department of Surgery, Regional Hospital, Wałbrzych.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kapuściński', 'Affiliation': 'Department of Radiotherapy, Regional Cancer Centre, Copernicus Memorial Hospital of Łódź, Łódź.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Suwiński', 'Affiliation': 'Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Gliwice, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bujko', 'Affiliation': 'II Department of Radiotherapy. Electronic address: krzysztof.bujko@coi.pl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz186'] 454,32248245,[Study protocol to improve the quality of delirium management in intensive care].,"BACKGROUND Delirium in cardiac surgery patients is common and is associated with prolonged mechanical ventilation and hospital stay as well as higher mortality. Protocols may improve outcome. In our cardiac surgery intensive care unit (ICU), patients with delirium have not received standardized treatment so far. HYPOTHESIS In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration. METHODS Prospective before/after study to evaluate a quality improvement project for delirium management over 12 weeks including 140 patients. INCLUSION CRITERIA (a) ≥18 years, (b) consent for research with their data. EXCLUSION CRITERIA (a) palliative status, (b) present during both the before/after phase, (c) pregnancy, (d) included in a competitive study, or (e) delirium not assessable. The implementation includes the introduction of a protocol with interprofessional training, bedside-teaching, pocket cards, posters, and reminders. The primary outcome is the duration of delirium, assessed four times a day with validated instruments. Secondary outcome measures include delirium incidence, duration of mechanical ventilation, length of stay in ICU and hospital, mortality, nursing/therapeutic interventions, cumulative doses of delirium-related drugs, and complications of delirium for a follow-up of 28 days. Empirical data will be analyzed with descriptive and inferential statistics. OBJECTIVES The purpose of the study is a reduction of the duration and frequency of delirium in cardiac ICU patients and will provide evidence of the effect size of the introduction of a delirium management.",2020,"In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration. ","['patients with delirium have not received standardized treatment so far', 'cardiac surgery patients', 'delirium management over 12\xa0weeks including 140 patients', 'd)\xa0included in a\xa0competitive study, or (e)\xa0delirium not assessable', 'cardiac ICU patients']",[],"['duration of delirium, assessed four times a\xa0day with validated instruments', 'delirium incidence, duration of mechanical ventilation, length of stay in ICU and hospital, mortality, nursing/therapeutic interventions, cumulative doses of delirium-related drugs, and complications of delirium for a\xa0follow-up of 28\xa0days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0150186', 'cui_str': 'Delirium management'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.178758,"In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration. ","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mohammad', 'Affiliation': 'Klinik für Herz und Gefäßchirurgie, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nydahl', 'Affiliation': 'Pflegeforschung; Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein Campus Kiel, Brunswiker Str.\xa010, 24116, Kiel, Deutschland. peter.nydahl@uksh.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borzikowsky', 'Affiliation': 'Institut für Medizinische Informatik und Statistik, Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Margraf', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Studt', 'Affiliation': 'Klinik für Integrative Psychiatrie ZIP gGmbH, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meyne', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kott', 'Affiliation': 'Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Panholzer', 'Affiliation': 'Klinik für Herz- und Gefäßchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}]","Medizinische Klinik, Intensivmedizin und Notfallmedizin",['10.1007/s00063-020-00676-1'] 455,32251170,"Efficacy and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction-A Randomized, Double-Masked, Sham-Controlled Clinical Trial: Erratum.",,2020,,['Patients With Meibomian Gland Dysfunction'],['Intense Pulsed Light'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.696524,,[],Cornea,['10.1097/ICO.0000000000002341'] 456,32251223,Effects of Auricular Acupressure on Women With Irritable Bowel Syndrome.,"The purpose of this study was to examine the effect of auricular acupressure on bowel symptoms, stress, mental health, and heart rate variability in women with irritable bowel syndrome (IBS). A quasi-experimental study design with a nonequivalent control group assessed a total sample of 56 women diagnosed with IBS according to Rome III criteria. There were 29 women in the experimental group who received auricular acupressure; 27 women were in the control group. Semen sinapis albae seeds were used to administer acupressure to four auricular points: endocrine, large intestine, lung, and Shenmen for 5 days/week for 4 weeks; the control group received no treatment. Bowel symptoms, stress, mental health, and heart rate variability were measured twice, once before and once after the intervention. Chi-square tests, t tests, and paired t tests were used for analysis. The experimental group had decreased loose stools, abdominal pain, diarrhea, abdominal discomfort, stress, and heart rate variability compared with the control group (p < .05). Auricular acupressure was effective for symptom improvement in patients with IBS.",2020,"The experimental group had decreased loose stools, abdominal pain, diarrhea, abdominal discomfort, stress, and heart rate variability compared with the control group (p < .05).","['women with irritable bowel syndrome (IBS', '56 women diagnosed with IBS according to Rome III criteria', 'patients with IBS', 'Women With Irritable Bowel Syndrome', '29 women in the experimental group who received']","['Auricular acupressure', 'auricular acupressure', 'Auricular Acupressure']","['Bowel symptoms, stress, mental health, and heart rate variability', 'bowel symptoms, stress, mental health, and heart rate variability', 'loose stools, abdominal pain, diarrhea, abdominal discomfort, stress, and heart rate variability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}]",56.0,0.0948883,"The experimental group had decreased loose stools, abdominal pain, diarrhea, abdominal discomfort, stress, and heart rate variability compared with the control group (p < .05).","[{'ForeName': 'Gee Youn', 'Initials': 'GY', 'LastName': 'Go', 'Affiliation': 'Gee Youn Go, PhD, RN, is Head Nurse, Dongkuk University Hospital, Ilsan, South Korea. Hyojung Park, PhD, RN, is Professor, College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hyojung', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000332'] 457,32247539,Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial.,"BACKGROUND This study investigated whether remifentanil infusion decreased intraoperative hyperglycaemia and insulin resistance compared with intermittent fentanyl administration in patients undergoing elective cardiac surgery. METHODS This was a randomised, prospective, open-label trial. Patients undergoing elective cardiac surgery (n=116) were randomised to receive either continuous intravenous remifentanil infusion or intermittent fentanyl boluses. Hourly blood glucose values were obtained for 24 h starting from induction of anaesthesia. The difference in percentage of patients with ≥2 intraoperative blood glucose concentrations >10 mM (180 mg dl -1 ) between the groups was the primary outcome measure. Secondary outcome measures included insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes. RESULTS The trial included 106 subjects in the final intention-to-treat analysis. There were fewer patients with ≥2 intraoperative blood glucose values >10 mM (180 mg dl -1 ) in the remifentanil group (17 [31.5%]) compared with the fentanyl group (33 [63.5%]) (relative risk: 0.50; 95% confidence interval [CI]: 0.32-0.77; P=0.001). The administered intraoperative insulin was a median of 8.1 units (range: 0-46.7) in the fentanyl group and 2.9 units (range: 0-35.1) in the remifentanil group (median difference=5 units; 95% CI: 1-7; P=0.004). Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines. Postoperative measures of glycaemic control and adverse clinical outcomes were not significantly different between groups. CONCLUSIONS Compared with patients treated with intermittent fentanyl, patients receiving continuous remifentanil infusion had fewer episodes of hyperglycaemia and less need for insulin administration during the intraoperative period of cardiac surgery. CLINICAL TRIAL REGISTRATION NCT02349152.",2020,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","['patients undergoing elective cardiac surgery', '106 subjects in the final intention-to-treat analysis', 'cardiac surgery', 'Patients undergoing elective cardiac surgery (n=116']","['remifentanil infusion', 'remifentanil', 'Remifentanil', 'continuous intravenous remifentanil infusion or intermittent fentanyl boluses']","['episodes of hyperglycaemia', '≥2 intraoperative blood glucose values', 'percentage of patients with ≥2 intraoperative blood glucose concentrations', 'Postoperative measures of glycaemic control and adverse clinical outcomes', 'Cortisol and adrenocorticotropic hormone', 'insulin requirements, select stress hormone and inflammatory cytokine concentrations, and safety events and adverse outcomes', 'intraoperative hyperglycaemia and insulin resistance', 'perioperative glycaemic response', 'Hourly blood glucose values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",106.0,0.436534,"Cortisol and adrenocorticotropic hormone were increased less in the remifentanil group (P<0.001), but there was no relative decrease in this group in select inflammatory cytokines.","[{'ForeName': 'Kathirvel', 'Initials': 'K', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: skathirvel@gmail.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sciortino', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Ruppert', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Monroe', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Esper', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boisen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Marquez', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hayanga', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Badhwar', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.028'] 458,32247603,"A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.","OBJECTIVE Angiogenesis inhibition is a valuable strategy for ovarian cancer (EOC). Pazopanib (paz) is a potent small molecular inhibitor of VEGF-1, -2, -3, PDGFR, c-kit, and has activity as a single agent in ovarian cancer. We designed a trial to assess the benefit of adding paz to gemcitabine (gem) in patients with recurrent EOC. METHODS An open-label, randomized, multi-site, phase 2 trial was conducted (NCT01610206) including patients with platinum resistant or sensitive disease, ≤ 3 prior lines of chemotherapy, and measurable/evaluable disease. Patients were randomly assigned to weekly gem 1000 mg/m 2 on days 1 and 8 of a 21 day cycle, with or without paz 800 mg QD, stratified by platinum sensitivity and number of prior lines (1 vs 2 or 3). The primary endpoint was PFS. RESULTS 148 patients were enrolled 2012-2017. Median age was 63 years (30-82); 60% were platinum resistant; median surveillance was 13 months (0.4-54 months). Median PFS was 5.3 (95% CI, 4.2-5.8) vs 2.9 months (95% CI, 2.1-4.1) in the gem arm. The PFS effect was most pronounced in the platinum resistant group (5.32 vs 2.33 months Tarone-Ware p < 0.001). There was no difference in OS. Overall RR (PR 20% vs 11%, Chi-squre p = 0.02) and DCR (80% vs 60%, Chi-square p < 0.001) were higher in the combination. High grade AEs in the combination arm included ≥ Grade 3: hypertension (15%), neutropenia (35%), and thrombocytopenia (12%). CONCLUSIONS The addition of paz to gem enhanced anti-tumor activity; those with platinum-resistant disease derived the most benefit from combination therapy, even in the setting of receiving prior bevacizumab.",2020,"Overall RR (PR 20% vs 11%, Chi-squre p = 0.02) and DCR (80% vs 60%, Chi-square","['ovarian cancer (EOC', 'patients with recurrent EOC', '148 patients were enrolled 2012-2017', 'Median age was 63 years (30-82); 60% were platinum resistant; median surveillance was 13 months (0.4-54 months', 'persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma', 'patients with platinum resistant or sensitive disease, ≤ 3 prior lines of chemotherapy, and measurable/evaluable disease']","['gemcitabine alone', 'Pazopanib (paz', 'bevacizumab', 'paz to gemcitabine', 'Tarone-Ware', 'gemcitabine plus pazopanib']","['PFS', 'Grade 3: hypertension', 'thrombocytopenia', 'Overall RR', 'DCR', 'neutropenia', 'Median PFS', 'PFS effect', 'OS']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0444864', 'cui_str': 'AM 13'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",148.0,0.105024,"Overall RR (PR 20% vs 11%, Chi-squre p = 0.02) and DCR (80% vs 60%, Chi-square","[{'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Virginia School of Medicine, Charlottesville, VA, USA. Electronic address: lduska@virginia.edu.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Varhegyi', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Levine Cancer Institute, Charlotte, NC, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jelovac', 'Affiliation': 'Department of Medicine, Division of Medical Oncology. Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'McGuire', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Darus', 'Affiliation': 'Maine Medical Center, Portland, ME, USA.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Barroilhet', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology. Univeristy of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Secord', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology. Duke Unviersity Medical Center, Durham, NC, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.10.014'] 459,31880365,Amisulpride and l-DOPA modulate subcortical brain nuclei connectivity in resting-state pharmacologic magnetic resonance imaging.,"The precise understanding of the dopaminergic (DA) system and its pharmacological modifications is crucial for diagnosis and treatment of neuropsychiatric disorders, as well as for understanding basic processes, such as motivation and reward. We probed the functional connectivity (FC) of subcortical nuclei related to the DA system according to seed regions defined according to an atlas of subcortical nuclei. We conducted a large pharmaco-fMRI study using a double-blind, placebo-controlled design, where we examined the effect of l -DOPA, a dopamine precursor, and amisulpride, a D2/D3-receptor antagonist on resting-state FC in 45 healthy young adults using a cross-over design. We examined the FC of subcortical nuclei with connection to the reward system and their reaction to opposing pharmacological probing. Amisulpride increased FC from the putamen to the precuneus and from ventral striatum to precentral gyrus. l -DOPA increased FC from the ventral tegmental area (VTA) to the insula/operculum and between ventral striatum and ventrolateral prefrontal cortex and it disrupted ventral striatal and dorsal caudate FC with the medial prefrontal cortex. In an exploratory analysis, we demonstrated that higher self-rated impulsivity goes together with a significant increase in VTA-mid-cingulate gyrus FC during l -DOPA-challenge. Therefore, our DA challenge modulated distinct large-scale subcortical connectivity networks. A dopamine-boost can increase midbrain DA nuclei connectivity to the cortex. The involvement of the VTA-cingulum connectivity in dependence of impulsivity has implications for diagnosis and therapy in disorders like ADHD.",2020,Amisulpride increased FC from the putamen to the precuneus and from ventral striatum to precentral gyrus.,['45 healthy young adults'],"['Amisulpride and l-DOPA', 'placebo', 'dopamine-boost', 'l -DOPA, a dopamine precursor, and amisulpride, a D2/D3-receptor antagonist', 'Amisulpride']","['FC', 'VTA-mid-cingulate gyrus FC', 'midbrain DA nuclei connectivity', 'l -DOPA increased FC']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0025462', 'cui_str': 'Midbrain'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",45.0,0.015836,Amisulpride increased FC from the putamen to the precuneus and from ventral striatum to precentral gyrus.,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Kopfer', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Küpper-Tetzel', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deppert', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Kuhn', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'de Greck', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Frankfurt, Germany.'}]",Human brain mapping,['10.1002/hbm.24913'] 460,32141709,"Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).","OBJECTIVE To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN Randomised controlled trial. SETTING Thirty-three UK hospitals. POPULATION Women having surgery for recurrent prolapse. METHODS Women recruited using remote randomisation. MAIN OUTCOME MEASURES Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.",2020,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"['Women having surgery for recurrent prolapse', 'women undergoing repeat prolapse surgery', 'Women recruited using remote randomisation', '33 UK hospitals', 'women having repeat anterior or posterior prolapse surgery']","['standard (native tissue) repair against synthetic mesh inlays or mesh kits', 'Mesh inlay, mesh kit or native tissue repair']","['Mean Pelvic Organ Prolapse Symptom Score', 'surgical revision', 'prolapse symptoms', 'Prolapse symptoms, condition specific quality-of-life and serious adverse effects', 'Cumulative mesh exposure rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",4.0,0.336306,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"[{'ForeName': 'Cma', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Freeman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Arb', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16197'] 461,31805386,Bony Ingrowth of Coil-Type Open-Architecture Anchors Compared With Screw-Type PEEK Anchors for the Medial Row in Rotator Cuff Repair: A Randomized Controlled Trial.,"PURPOSE To evaluate outcomes of screw-type and coil-type open-architecture suture anchors with respect to bony ingrowth, release of biological markers, and patient-reported outcome measures when used in rotator cuff repair (RCR). METHODS Forty patients undergoing arthroscopic RCR for full-thickness rotator cuff tears were enrolled and prospectively randomized to receive a screw-type (19 patients) or coil-type (21 patients) suture anchor for the medial row during repair. All repairs used a transosseous-equivalent configuration with footprint anchors laterally. Marrow elements released during surgery were evaluated for 9 cytokine markers (insulin-like growth factor 1, fibroblast growth factor 2, bone morphogenetic proteins 7 and 2, platelet-derived growth factors AA and BB, epidermal growth factor, transforming growth factor beta1, and vascular endothelial growth factor). Postoperative computed tomography scans were performed at 6 months. Range of motion, strength, and validated patient-reported outcome measures (Simple Shoulder Test, Single Assessment Numeric Evaluation, visual analog scale, and American Shoulder and Elbow Surgeons scores) were gathered before the operation and at 6 months and 1 year postoperatively. RESULTS Bone mineral density surrounding the coil-type anchor was significantly greater than that surrounding the screw-type anchor (P = .005). Bone mineral density values within the coil-type and screw-type anchors were comparable (P = .527); however, a larger amount of total bone mineral mass (in milligrams) was shown within the coil-type anchor owing to its larger volume (P < .01). Marrow elements released at the repair site were similar between groups (P > .05). Postoperatively, no statistically significant difference was found between groups for clinical outcome measures at 6 months or 1 year. Retear and complication rates were similar between groups (P > .05). CONCLUSIONS Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes. The coil-type anchor resulted in superior bony growth surrounding the anchor and a larger total bone mineral mass within the anchor owing to its larger volume. LEVEL OF EVIDENCE Level II, randomized prospective comparative study.",2020,Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes.,"['Rotator Cuff Repair', 'for full-thickness rotator cuff tears', 'Forty patients undergoing']","['Coil-Type Open-Architecture Anchors', 'screw-type (19 patients) or coil-type (21 patients) suture anchor for the medial row during repair', 'screw-type and coil-type open-architecture suture anchors', 'arthroscopic RCR']","['Retear and complication rates', 'total bone mineral mass', 'Range of motion, strength, and validated patient-reported outcome measures (Simple Shoulder Test, Single Assessment Numeric Evaluation, visual analog scale, and American Shoulder and Elbow Surgeons scores', 'Bone mineral density values', 'rotator cuff repair (RCR']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0410017', 'cui_str': 'Complete rupture of rotator cuff'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]",40.0,0.0819321,Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes.,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Chahla', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Loma Linda University Medical Center, Loma Linda, California, U.S.A.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Manderle', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Beletsky', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Cabarcas', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Anirudh K', 'Initials': 'AK', 'LastName': 'Gowd', 'Affiliation': 'Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, U.S.A.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chubinskaya', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Trenhaile', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Forsythe', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.. Electronic address: Nikhil.verma@rushortho.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.11.119'] 462,32084445,Reducing cardiovascular risk among people living with HIV: Rationale and design of the INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) randomized controlled trial.,"Cardiovascular disease (CVD) is a major cause of morbidity among people living with HIV (PLWH). Statins can safely and effectively reduce CVD risk in PLWH, but evidence-based statin therapy is under-prescribed in PLWH. Developed using an implementation science framework, INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) is a stepped-wedge cluster randomized trial that addresses organization-, clinician- and patient-level barriers to statin uptake in Los Angeles community health clinics serving racially and ethnically diverse PLWH. After assessing knowledge about statins and barriers to clinician prescribing and patient uptake, we will design, implement and measure the effectiveness of (1) educational interventions targeting leadership, clinicians, and patients, followed by (2) behavioral economics-informed clinician feedback on statin uptake. In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.",2020,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","['people living with HIV', 'people living with HIV (PLWH']",['Statin'],"['clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation', 'cardiovascular risk']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",2.0,0.0964372,"In addition, we will assess implementation outcomes, including changes in clinician acceptability of statin prescribing for PLWH, clinician acceptability of the education and feedback interventions, and cost of implementation.","[{'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Takada', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ober', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA; Department of Psychology, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Tamara B', 'Initials': 'TB', 'LastName': 'Horwich', 'Affiliation': 'Division of Cardiology, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Division of Health Services Research & Implementation Science, Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Shu', 'Affiliation': 'UCLA Anderson School of Management, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Vijayan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Wali', 'Affiliation': 'Department of Medicine, Olive View-UCLA Medical Center, Sylmar, CA, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Cunningham', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA. Electronic address: JLadapo@mednet.ucla.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.02.012'] 463,32118694,Association Between Resilience and Psychological Morbidity in Parents of Critically Ill Children.,"OBJECTIVE To determine whether parental resilience, measured at ICU admission, is associated with parent-reported symptoms of depression, anxiety, posttraumatic stress, and satisfaction with ICU care 3-5 weeks following ICU discharge. DESIGN Planned prospective, observational study nested in a randomized comparative trial. SETTING PICUs and cardiac ICUs in two, free-standing metropolitan area children's hospitals. PARTICIPANTS English- and Spanish-speaking parents whose children were younger than 18 years old and had anticipated ICU stay of greater than 24 hours or Pediatric Index of Mortality score of greater than or equal to 4 at the time of consent. All ICU admissions were screened for inclusion. Of 4,251 admissions reviewed, 1,360 were eligible. Five hundred families were approached and 382 enrolled. Two hundred thirty-two parents from 210 families with complete data were included in analysis. INTERVENTIONS All participating parents completed the Connor-Davidson Resilience Scale at the time of consent and outcome measures 3-5 weeks after ICU discharge. MEASUREMENTS AND MAIN RESULTS All parents completed the Patient-Reported Outcome Measurement Information System Short Forms 8a for Depression and Anxiety, Impact of Event Scale-Revised for posttraumatic stress, and Pediatric Family Satisfaction-ICU 24 for parental satisfaction 3-5 weeks after ICU discharge. Higher parental resilience was associated with fewer symptoms of depression, anxiety, and posttraumatic stress in the final model (all p < 0.0001). Shorter length of stay, early mechanical ventilation, Latino ethnicity, and lower illness severity (both objective and parental perceptions) were associated with less morbidity in some or all measured mental health outcomes. CONCLUSIONS Higher parental resilience is associated with fewer reported symptoms of anxiety, depression, and posttraumatic stress 3-5 weeks after ICU discharge. Parental resilience may impact parental post-ICU psychological morbidity. Measuring parental resilience could be one approach to identify parents at risk for post-ICU psychological morbidity. Future research into the impact of interventions designed to boost parental resilience is warranted.",2020,"Higher parental resilience was associated with fewer symptoms of depression, anxiety, and posttraumatic stress in the final model (all p < 0.0001).","[""PICUs and cardiac ICUs in two, free-standing metropolitan area children's hospitals.\nPARTICIPANTS\n\n\nEnglish- and"", 'Two hundred thirty-two parents from 210 families with complete data were included in analysis', 'Five hundred families were approached and 382 enrolled', 'Spanish-speaking parents whose children were younger than 18 years old and had anticipated ICU stay of greater than 24 hours or Pediatric Index of Mortality score of greater than or equal to 4 at the time of consent', 'Parents of Critically Ill Children', 'Of 4,251 admissions reviewed, 1,360 were eligible']",[],"['Depression and Anxiety, Impact of Event Scale-Revised for posttraumatic stress, and Pediatric Family Satisfaction-ICU 24 for parental satisfaction', 'Connor-Davidson Resilience Scale', 'symptoms of depression, anxiety, and posttraumatic stress', 'Shorter length of stay, early mechanical ventilation, Latino ethnicity, and lower illness severity (both objective and parental perceptions']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1278786', 'cui_str': 'Admission review'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised (assessment scale)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0222045'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",500.0,0.0817445,"Higher parental resilience was associated with fewer symptoms of depression, anxiety, and posttraumatic stress in the final model (all p < 0.0001).","[{'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Rothschild', 'Affiliation': 'Division of Critical Care Medicine, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Rychlik', 'Affiliation': ""Stanley Manne Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Goodman', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Charleston', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Brown', 'Affiliation': ""Department of Pain Medicine, Palliative Care, and Integrative Medicine, Children's Minnesota, Minneapolis, MN.""}, {'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Michelson', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002237'] 464,31805385,Should Preoperative Fascia Iliaca Block Be Used for Hip Arthroscopic Labral Repair and Femoroacetabular Impingement Treatment? A Prospective Single Blinded Randomized Study.,"PURPOSE To evaluate the analgesic effect of preoperative fascia iliaca block on postoperative morphine equivalent dose, pain level, and patient satisfaction for patients electing to undergo primary hip arthroscopic labral repair with osteochondroplasty. METHODS This prospective study included 60 patients (fascia iliaca block group: n = 27; control group: n = 33) undergoing elective arthroscopic hip surgery by a single board-certified orthopedic surgeon, fellowship trained in hip arthroscopy. Participants for the study included patients older than 10 years of age and younger than 85 years of age, American Society of Anesthesiologists classifications I to III, diagnosed with symptomatic femoroacetabular impingement, and/or hip labral tear, and/or cartilage damage, and electing to undergo arthroscopic hip surgery. Patients were randomized by surgical date to receive preoperative fascia iliaca block or control (no fascia iliaca block). Preoperative fascia iliaca block was administered by 1 of 4 board certified anesthesiologists using identical anesthetic (35-40 mL ropivacaine 0.35%). Postoperative morphine equivalent dose, self-reported pain level (visual analog scale) and patient satisfaction were measure postoperatively. RESULTS There were no significant differences between the control group and the fascia iliaca block group in sex, age, height, weight, or body mass index. There was a significant difference between the 2 groups in distribution of American Society of Anesthesiologists classification (p = .031). There were no significant differences in postoperative morphine equivalent dose for patients receiving fascia iliaca block compared with the control group. There were no significant differences in self-reported visual analog scale pain and patient satisfaction between the 2 groups at any of the measured time points following surgery. CONCLUSIONS Based on the results of this study, routine preoperative fascia iliaca block for elective hip arthroscopic labral repair and treatment of femoroacetabular impingement is not recommended. LEVEL OF EVIDENCE Level II, prospective single blinded randomized study.",2020,There were no significant differences in postoperative morphine equivalent dose for patients receiving fascia iliaca block compared with the control group.,"['patients electing to undergo primary hip arthroscopic labral repair with osteochondroplasty', 'Participants for the study included patients older than 10 years of age and younger than 85 years of age, American Society of Anesthesiologists classifications I to III, diagnosed with symptomatic femoroacetabular impingement, and/or hip labral tear, and/or cartilage damage, and electing to undergo arthroscopic hip surgery', '60 patients (fascia iliaca block group: n\xa0= 27; control group: n\xa0=\xa033) undergoing']","['preoperative fascia iliaca block or control (no fascia iliaca block', 'elective arthroscopic hip surgery by a single board-certified orthopedic surgeon, fellowship trained in hip arthroscopy']","['self-reported visual analog scale pain and patient satisfaction', 'Postoperative morphine equivalent dose, self-reported pain level (visual analog scale) and patient satisfaction', 'distribution of American Society of Anesthesiologists classification', 'pain level, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0334891', 'cui_str': 'Orthopedists'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]",60.0,0.0607526,There were no significant differences in postoperative morphine equivalent dose for patients receiving fascia iliaca block compared with the control group.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Huang', 'Affiliation': 'Colorado Springs Orthopaedic Group, Colorado Springs, Colorado, U.S.A.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Wages', 'Affiliation': 'Colorado Springs Orthopaedic Group, Colorado Springs, Colorado, U.S.A.. Electronic address: jwages17@gmail.com.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Henry', 'Affiliation': 'Colorado Springs Orthopaedic Group, Colorado Springs, Colorado, U.S.A.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Epperson', 'Affiliation': 'Department of Anesthesia, UCHealth Anesthesia, Colorado Springs, Colorado, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.11.118'] 465,3422694,Simplifying infusion chemotherapy: preliminary communication.,"A low-intervention policy for Hickman catheter maintenance has been evaluated and found to be safe and cost effective. A simple, lightweight, disposable device has been used for 24-hour ambulatory home infusion. Implementation of this policy as part of a prospective randomized trial of single-agent chemotherapy in advanced breast cancer has demonstrated that slow intravenous infusion reduces the acute toxicity of epirubicin when compared with bolus injection.",1988,A low-intervention policy for Hickman catheter maintenance has been evaluated and found to be safe and cost effective.,['advanced breast cancer'],['single-agent chemotherapy'],['acute toxicity of epirubicin'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]",,0.0138883,A low-intervention policy for Hickman catheter maintenance has been evaluated and found to be safe and cost effective.,"[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Ebbs', 'Affiliation': ""Department of Surgery, King's College Hospital, Rayne Institute, London.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Saunders', 'Affiliation': ''}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bates', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Morris', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 466,32246238,A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated unilateral inguinal hernia.,"BACKGROUND Routine TEP technique requires three skin incisions for placement of three trocars in the midline. Otherwise, this can be done by three-port triangular technique or two-hand technique. This study reports a randomised trial of perioperative outcomes and ergonomics characteristics of this procedure using two different techniques of port insertion. METHODS N = 28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval. Patient-related outcomes in terms of quality of life (QOL) and ergonomic evaluation of the technique were compared in double-blinded fashion. RESULTS Postoperative pain score at 24 h post surgery (5.1 ± 0.6; 95% CI 4.9-5.3 vs. 4.8 ± 0.4; 95% CI 4.6-4.9) differed, while hospital stay, time to return to routine work, tolerance to oral feeds and intraoperative complications occurrence (OR 2.1; 95% CI 0.2-24.3) were comparable in both groups. Time to return to office work (5.5 ± 0.5; 95% CI 5.4-5.7 vs. 4.0 ± 0.8; 95% CI 3.7-4.3) and immediate postoperative sensation of mesh and pain score were significantly higher in MTEP compared to TTEP. Ergonomic parameters including visualization of landmark score, spreading of mesh score and total surgeon satisfaction score (TTEP 8.4 ± 0.7; 95% CI 8.1-8.6 vs. MTEP 7.0 ± 0.8; 95% CI 6.7-7.3), mental effort quotient (SMEQ score: TTEP 50.6 ± 12.7; 95% CI 45.9-55.3 vs. MTEP 70.8 ± 12.6: 95% CI 66.1-75.4) and physical effort quotient (LEDQ scores in wrist, hand, arm and shoulders) were also superior in triangular technique of port placement. CONCLUSION Triangular three-port TEP hernioplasty is ergonomically feasible and enables a surgeon to perform surgery safely using basic principles of laparoscopy.",2020,"28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval.","['28 patients', 'N\u2009', ""after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval"", 'total extra-peritoneal repair of uncomplicated unilateral inguinal hernia']","['triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty', 'Triangular three-port TEP hernioplasty', 'triangular versus midline port placement']","['Postoperative pain score', 'hospital stay, time to return to routine work, tolerance to oral feeds and intraoperative complications occurrence', 'physical effort quotient (LEDQ scores', 'quality of life (QOL) and ergonomic evaluation of the technique', 'Time to return to office work', 'visualization of landmark score, spreading of mesh score and total surgeon satisfaction score', 'immediate postoperative sensation of mesh and pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",28.0,0.193308,"28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval.","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Awanish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India. awanishkr79@gmail.com.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Pal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Agrawal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Pahwa', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Abhinav A', 'Initials': 'AA', 'LastName': 'Sonkar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}]",Surgical endoscopy,['10.1007/s00464-020-07525-4'] 467,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2 IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2 IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783'] 468,32145440,Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.,"BACKGROUND Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. METHODS We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. CONCLUSION GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.",2020,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"['176 patients', 'patients with PAD experience claudication despite adequate medical and/or surgical management', 'patients with lower extremity PAD']","['GM-CSF', 'placebo', 'Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF', 'granulocyte-macrophage colony stimulating factor', 'placebo group receive matching placebo injections', 'placebo injections']",['change in 6-min walk distance between baseline and 6-month follow-up'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.40022,Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials.,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mehta', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Rogers', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Devinder S', 'Initials': 'DS', 'LastName': 'Dhindsa', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Risha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Martini', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahadev', 'Initials': 'M', 'LastName': 'Prasad', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtari', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Iraj G', 'Initials': 'IG', 'LastName': 'Hesaroieh', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Frohwein', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Kutner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Harzand', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; Atlanta VA Medical Center, Decatur, Georgia.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Wells', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Duwayri', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Olamide', 'Initials': 'O', 'LastName': 'Alabi', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Rajani', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Brewster', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Winship Cancer Institute, Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. Electronic address: Aquyyum@Emory.Edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105975'] 469,32184197,A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP).,"Lung cancer screening with low-dose computed tomography (LDCT) reduces lung cancer mortality, yet few eligible high-risk patients receive it annually. This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways. This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month ""steps"" with pre-intervention data serving as the control. The primary outcome is whether delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings. Six participating centers will identify 10 practices and reach 2-3 providers per practice to train them to use the Toolkit. The Toolkit will address known barriers to screening and referral at the patient and provider levels and provide support for required elements of screening. Toolkit components include adaptable evidence-based interventions to maximize compatibility with workflows. We hypothesize that after nine months of intervention delivery, the number of initial screening per center will double. Involving 60 practices achieves 80% power at 5% level of significance. Implementation outcomes such as adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs. LDCT for lung cancer screening currently reaches a small fraction of eligible adults. To reach the full potential to reduce mortality, primary care practices are an important venue for increasing appropriate referrals. This multidisciplinary trial will encourage acceptability and sustainability by using local knowledge and promoting partnership between providers and patients. Trial registration: ClinicalTrials.gov, NCT03958253.",2020,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,[],"['LDCT', 'Lung cancer screening with low-dose computed tomography (LDCT', 'community-partnered intervention (Toolkit) designed to support primary care practices', 'community intervention']","['adoption, acceptability, feasibility, adaptation, and sustainability will be assessed through field-notes and activity logs', 'delivery of the Toolkit to primary care practices results in a monthly increase in number of initial LDCT screenings', 'lung cancer mortality']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.158435,This protocol describes a community-partnered intervention (Toolkit) designed to support primary care practices in making referrals for lung screening and guiding patients into appropriate screening pathways.,"[{'ForeName': 'Ana S', 'Initials': 'AS', 'LastName': 'Salazar', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: a.salaza@wustl.edu.'}, {'ForeName': 'Subhjit', 'Initials': 'S', 'LastName': 'Sekhon', 'Affiliation': 'University of Missouri-Kansas City, USA. Electronic address: sks3t4@mail.umkc.edu.'}, {'ForeName': 'Karthik W', 'Initials': 'KW', 'LastName': 'Rohatgi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: karthik.rohatgi@wustl.edu.'}, {'ForeName': 'Akua', 'Initials': 'A', 'LastName': 'Nuako', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aanuako@wustl.edu.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: esther@wustl.edu.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Harriss', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: courtney.harriss@wustl.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Brennan', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: ellen.brennan@bjc.org.'}, {'ForeName': 'Dareld', 'Initials': 'D', 'LastName': 'LaBeau', 'Affiliation': 'Siteman Cancer Center at Barnes-Jewish St. Peters Hospital, 150 Entrance Way, St. Peters, MO 63376, USA. Electronic address: dareld.labeau@bjc.org.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdalla', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: ibrahim.abdalla@coxhealth.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schulze', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: chris.schulze@coxhealth.com.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Muenks', 'Affiliation': 'Hulston Cancer Center, CoxHealth, 3850 S National, Springfield, MO 65807, USA. Electronic address: jackie.muenks@coxhealth.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Overlot', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: daveo@dmhhs.org.'}, {'ForeName': 'Jeri Ann', 'Initials': 'JA', 'LastName': 'Higgins', 'Affiliation': 'Cancer Care Center of Decatur, Decatur Memorial Hospital, 210 W. McKinley Avenue, Decatur, IL 62526, USA. Electronic address: jerih@dmhhs.org.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Jones', 'Affiliation': 'Regional Cancer Center, Memorial Health System, 701 N 1(st), Springfield, IL 62781, USA. Electronic address: jones.linda@mhsil.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Swick', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: cswick@sblhs.org.'}, {'ForeName': 'Stacia', 'Initials': 'S', 'LastName': 'Goings', 'Affiliation': 'Sarah Bush Lincoln Regional Cancer Center, Sarah Bush Lincoln Health System, 1001 Health Center Drive, Mattoon, IL 61938, USA. Electronic address: sgoings@sblhs.org.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Badiu', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: jennifer.badiu@sih.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'SIH Cancer Institute, Southern Illinois Healthcare, 1400 Pin Oak Drive, Carterville, IL 62918, USA. Electronic address: Justin.Walker@sih.net.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: colditzg@wustl.edu.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave, Campus Box 8100, St. Louis, MO 63110-0193, USA. Electronic address: aimeejames@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105991'] 470,32092321,"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide at a Dose of 30 μg/kg Ideal Body Weight/hr in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis Receiving Oxygen Therapy.","BACKGROUND The interstitial lung diseases include a variety of disorders, many of which are characterized by fibrotic changes (fILD). Of the fILDs, Idiopathic pulmonary fibrosis is the most common. Pulmonary hypertension (PH) frequently complicates fILD and is associated with impaired functional capability, lower physical activity, and significantly reduced life expectancy. There is no proven treatment for patients with fILD-PH. We report results from the first cohort of a phase 2b/3 trial with pulsed inhaled nitric oxide (iNO) in patients with fILD-PH. METHODS Subjects in cohort 1 were randomized to iNO 30 μg/kg ideal body weight/hr (iNO30) or placebo for 8 weeks of blinded treatment; subjects then transitioned to open-label extension (OLE) on iNO30 followed by dose escalation to iNO45 then iNO75. Activity monitoring was used to assess changes in daily activity. Safety and efficacy were evaluated. RESULTS Twenty-three patients were randomized to iNO30 and 18 to placebo. During blinded treatment, iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity. Placebo subjects showed an average drop of 26% in MVPA and a 12% drop in overall activity. The iNO group had an improvement in oxygen saturation. During OLE, subjects maintained their activity levels including placebo subjects who transitioned from a decline to a maintenance in all activity parameters. Inhaled nitric oxide at all doses (30, 45, and 75) was safe and well tolerated. CONCLUSIONS Treatment with iNO30 demonstrated clinically and statistically significant benefit in MVPA and clinically significant benefit in overall activity. In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters.",2020,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"['subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) receiving Oxygen Therapy', 'patients with fILD-PH', 'patients with fILD-PH.\nMETHODS\n\n\nSubjects in Cohort 1']","['iNO 30 mcg/kg IBW/hr (iNO30) or placebo', 'placebo', 'pulsed, inhaled nitric oxide (iNO', 'pulsed iNO', 'Placebo']","['safety and efficacy', 'overall activity', 'activity levels', 'Safety and efficacy', 'oxygen saturation', 'safe and well tolerated', 'moderate/vigorous physical activity (MVPA']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",23.0,0.139946,During blinded treatment iNO30 subjects showed an average improvement in moderate/vigorous physical activity (MVPA) and remained stable in overall activity.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Heart and Vascular Institute, Inova Fairfax Hospital, Richmond, VA; Virginia Commonwealth University, Richmond, VA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Marilyn K', 'Initials': 'MK', 'LastName': 'Glassberg', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'the University of Arizona College of Medicine - Phoenix and Banner; University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Swigris', 'Affiliation': 'Department of Medicine, National Jewish, Denver, CO.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': 'The Lung Research Center-Missouri, Chesterfield, MO.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Loyd', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Gillies', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Bellerophon Therapeutics, Warren, NJ.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lancaster', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}]",Chest,['10.1016/j.chest.2020.02.016'] 471,32081787,Analysis of the Whole CDR3 T Cell Receptor Repertoire after Hematopoietic Stem Cell Transplantation in 2 Clinical Cohorts.,"A major cause of morbidity and mortality for patients who undergo hematologic stem cell transplantation (HSCT) is acute graft-versus-host disease (aGVHD), a mostly T cell-mediated disease. Examination of the T cell receptor (TCR) repertoire of HSCT recipients and the use of next-generation nucleotide sequencing have raised the question of whether features of TCR repertoire reconstitution might reproducibly associate with aGVHD. We hypothesized that the peripheral blood TCR repertoire of patients with steroid-nonresponsive aGVHD would be less diverse. We also hypothesized that patients with GVHD who shared HLA might also share common clones at the time of GVHD diagnosis, thereby potentially providing potential clinical indicators for treatment stratification. We further hypothesized that HSCT recipients with the same HLA mismatch might share a more similar TCR repertoire based on a potentially shared focus of alloreactive responses. We studied 2 separate patient cohorts and 2 separate platforms for measuring TCR repertoire. The first cohort of patients was from a multicenter Phase III randomized double-blinded clinical trial of patients who developed aGVHD (NCT01002742). The second cohort comprised samples from biobanks from 2 transplantation centers and the Center for International Blood and Marrow Transplant Research of patients who underwent mismatched HSCT. There were no statistically significant differences in the TCR diversity of steroid responders and nonresponders among patients with aGVHD on the day of diagnosis. Most clones in the repertoire were unique to each patient, but a small number of clones were found to be both exclusive to and shared among aGVHD nonresponders. We were also able to show a strong correlation between the presence of Vβ20 and Vβ29 and steroid responsiveness. Using the Bhattacharya coefficient, those patients who shared the same HLA mismatch were shown to be no more similar to one another than to those who had a completely different mismatch. Using 2 separate clinical cohorts and 2 separate platforms for analyzing the TCR repertoire, we have shown that the sampled human TCR repertoire is largely unique to each patient but contains glimmers of common clones of subsets of clones based on responsiveness to steroids in aGVHD on the day of diagnosis. These studies are informative for future strategies to assess for reproducible TCR responses in human alloreactivity and possible markers of GVHD responsiveness to therapy.",2020,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"['patients with steroid non-responsive, acute GVHD', 'patients with GVHD', 'patients who undergo hematological stem cell transplantations (HSCT']",['HSCT'],"['TCR diversity of steroid responders', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]",[],"[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0473044,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Shah', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Tamaresis', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Laura Jean', 'Initials': 'LJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Rangarajan', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Spellman', 'Affiliation': 'National Marrow Donor Program/C Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zehnder', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Everett H', 'Initials': 'EH', 'LastName': 'Meyer', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California. Electronic address: evmeyer@stanford.edu.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.01.020'] 472,31243641,Effects of Macuprev ® Supplementation in Age-Related Macular Degeneration: A Double-Blind Randomized Morpho-Functional Study Along 6 Months of Follow-Up.,"BACKGROUND To evaluate the effects of Macuprev ® supplementation on macular function and structure in intermediate age-related macular degeneration (AMD) along 6 months of follow-up. METHODS In this double-blind, monocentric, randomized, and prospective study, 30 patients with intermediate AMD were enrolled and randomly divided into two age-similar groups: 15 patients (AMD-M group; mean age 68.50 ± 8.79 years) received 6-month oral daily supplementation with Macuprev ® (Farmaplus Italia s.r.l., Italy, two tablets/day on an empty stomach, before meals; contained in total lutein 20 mg, zeaxanthin 4 mg, N-acetylcysteine 140 mg, bromelain 2500GDU 80 mg, vitamin D 3 800 IU, vitamin B 12 18 mg, alpha-lipoic acid 140 mg, rutin 157 mg, vitamin C 160 mg, zinc oxide 16 mg, Vaccinium myrtillus 36% anthocyanosides 90 mg, Ganoderma lucidum 600 mg) and 15 patients (AMD-P group; mean age 70.14 ± 9.87) received two tablets of placebo daily on an empty stomach, before meals. A total of 28 eyes, 14 from each AMD group, completed the study. Multifocal electroretinogram (mfERG) and spectral domain-optical coherence tomography (SD-OCT) were assessed at baseline and after 6 months. RESULTS At 6-month follow-up, AMD-M eyes showed a significant increase of mfERG response amplitude density (RAD) recorded from the central macular areas (ring 1, 0-2.5°; ring 2, 2.5-5°), whereas non-significant changes of retinal and choroidal SD-OCT parameters were found when values were compared to baseline. Non-significant correlations between functional and structural changes were found. In AMD-P eyes, non-significant differences for each mfERG and SD-OCT parameters were observed at 6 months. CONCLUSIONS In intermediate AMD, Macuprev ® supplementation increases the function of the macular pre-ganglionic elements, with no associated retinal and choroidal ultra-structural changes. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03919019. FUNDING Research for this study was financially supported by the Italian Ministry of Health and Fondazione Roma. Article processing charges were funded by Farmaplus Italia s.r.l., Italy.",2019,"In AMD-P eyes, non-significant differences for each mfERG and SD-OCT parameters were observed at 6 months. ","['Age-Related Macular Degeneration', '30 patients with intermediate AMD were enrolled and randomly divided into two age-similar groups: 15 patients (AMD-M group; mean age 68.50\u2009±\u20098.79\xa0years) received', '15 patients (AMD-P group; mean age 70.14\u2009±\u20099.87', 'A total of 28 eyes, 14 from each AMD group, completed the study']","['Macuprev ® Supplementation', 'zeaxanthin', 'placebo', 'alpha-lipoic acid 140\xa0mg, rutin 157\xa0mg, vitamin C 160\xa0mg, zinc oxide', 'bromelain 2500GDU 80\xa0mg, vitamin D 3 800\xa0IU, vitamin B 12 18', 'Macuprev ® supplementation', 'Ganoderma lucidum', '6-month oral daily supplementation with Macuprev ® (Farmaplus Italia s.r.l']","['mfERG response amplitude density (RAD', 'Multifocal electroretinogram (mfERG) and spectral domain-optical coherence tomography (SD-OCT', 'retinal and choroidal SD-OCT parameters', 'mfERG and SD-OCT parameters']","[{'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0035976', 'cui_str': 'rutoside'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043491', 'cui_str': 'Zinc Oxide'}, {'cui': 'C0293742', 'cui_str': 'Stem bromelain'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0752326', 'cui_str': 'Ganoderma lucidum'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.209811,"In AMD-P eyes, non-significant differences for each mfERG and SD-OCT parameters were observed at 6 months. ","[{'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Parravano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tedeschi', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Manca', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Costanzo', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Renzo', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giorno', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Barbano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ziccardi', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy. luxzic@hotmail.com.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Varano', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Parisi', 'Affiliation': 'IRCCS Fondazione Bietti, Rome, Italy.'}]",Advances in therapy,['10.1007/s12325-019-01016-2'] 473,30753303,Rehabilitation After Hip Fracture for Nursing Home Residents: A Controlled Feasibility Trial.,"BACKGROUND This study compared functional outcomes at 3 months after hip fracture surgery between nursing home residents participating in a 10-week outreach rehabilitation program and those receiving usual care. Function, health-related quality of life, and mortality were also compared over 12 months, and outreach program feasibility was assessed. METHODS A feasibility trial was undertaken in Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition. Outreach participants received 10 weeks of rehabilitation (30 sessions), and Control participants received usual posthospital fracture care in their nursing homes. The primary outcome was the Functional Independence Measure Physical Domain (FIMphysical) score 3 months post-fracture; we also explored FIM Locomotion and Mobility. Secondary outcomes were FIM scores, EQ-5D-3L scores, and mortality over 12 months. Program feasibility was also evaluated. RESULTS The mean age was 88.7 ± 7.0 years, 55 (71%) were female, and 58 (75%) had severe cognitive impairment with no significant group differences (p > .14). Outreach participants had significantly higher FIM Locomotion than usual care (p = .02), but no significant group differences were seen in FIMphysical or FIM Mobility score 3 months post-fracture. In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared with Control participants over 12 months (p < .05). Mortality did not differ by group (p = .80). Thirty (65%) Outreach participants completed the program. CONCLUSIONS Our feasibility trial demonstrated that Outreach participants achieved better locomotion by 3 months post-fracture compared with participants receiving usual postfracture care; benefits were sustained to 12 months post-fracture. In adjusted analyses, Outreach participants also showed sustained benefits in physical function and health-related quality of life.",2019,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","['Canadian nursing homes; of 77 participants, 46 were allocated to Outreach and 31 to Control prior to assessing function or cognition', 'Nursing Home Residents', 'hip fracture surgery between nursing home residents participating in a 10-week']","['outreach rehabilitation program and those receiving usual care', 'rehabilitation (30 sessions) and Control participants received usual post-hospital fracture care in their nursing homes']","['Mortality', 'Function, health-related quality of life (HRQL) and mortality', 'FIM scores, EQ-5D-3L scores and mortality over 12-months', 'FIM Locomotion and Mobility', 'better locomotion', 'FIM Locomotion', 'FIM and EQ-5D-3L scores', 'physical function and HRQL', 'severe cognitive impairment', 'Functional Independence Measure Physical Domain(FIMphysical) score', 'FIMphysical or FIM Mobility score']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1160964', 'cui_str': 'Fracture care'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",77.0,0.0812392,"In adjusted analyses, Outreach participants reported significant improvements in all FIM and EQ-5D-3L scores compared to Control participants over 12-months(p<0.05).","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Magaziner', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'C Allyson', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Gian S', 'Initials': 'GS', 'LastName': 'Jhangri', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'D William C', 'Initials': 'DWC', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz031'] 474,31278694,"A Randomized, Crossover Study on the Effect of Food on the Pharmacokinetic Characteristics of Morphine ARER (MorphaBond™ ER), an Abuse-Deterrent Formulation of Extended-Release Morphine.","INTRODUCTION Food can alter the pharmacokinetics of certain abuse-deterrent formulations. Morphine ARER is an oral abuse-deterrent formulation of ER morphine sulfate tablets formulated with physical and chemical properties that contribute to the abuse-deterrent aspects of the drug. This study compared the relative bioavailability of Morphine ARER in the presence and absence of food. METHODS This was a randomized, single-dose, two-treatment, crossover study in which healthy adults received Morphine ARER 100 mg under fasting and fed conditions. Subjects were given naltrexone 50 mg to limit opioid effects. Plasma concentrations of morphine and its active metabolite morphine-6-glucuronide (M6G) were obtained up to 48 h post-dose; area under the plasma concentration-time curve (AUC) from time 0 extrapolated to infinity (AUC 0-∞ ), maximum observed plasma concentration (C max ) and time to C max (T max ) were calculated. Safety was evaluated by observation or report of adverse events, which were monitored during the treatment periods. RESULTS Of 28 enrolled subjects, 27 completed all treatments; 1 subject in the fasted group withdrew voluntarily. Under fed conditions, the C max for morphine was 33% higher (44.78 vs. 33.30 ng/ml for fed and fasted conditions, respectively) and the median T max was 30 min longer than under fasted conditions. The overall morphine exposure (AUC 0-∞ ) was similar for fed (440.6 ng · h/ml) vs. fasted conditions (395.1 ng · h/ml). For M6G, the C max and AUC 0-∞ were similar under both conditions, and the median T max for M6G was 60 min longer under fed conditions. Common adverse events were somnolence and nausea. CONCLUSION Morphine ARER can be administered without regard to food. Plain language summary available for this article. FUNDING Inspirion Delivery Sciences, LLC.",2019,The overall morphine exposure (AUC 0-∞ ) was similar for fed (440.6 ng · h/ml) vs. fasted conditions (395.1 ng · h/ml).,"['healthy adults', 'Of 28 enrolled subjects, 27 completed all treatments']","['Morphine ARER 100\xa0mg under fasting and fed conditions', 'Morphine ARER', 'naltrexone', 'morphine', 'Morphine ARER (MorphaBond™ ER', 'Morphine']","['plasma concentration-time curve (AUC', 'somnolence and nausea', 'plasma concentration (C max ) and time to C max (T max ', 'Plasma concentrations of morphine and its active metabolite morphine-6-glucuronide (M6G', 'Safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4224864', 'cui_str': 'Morphabond'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0066816', 'cui_str': 'morphine-6beta-glucuronide'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",28.0,0.0700176,The overall morphine exposure (AUC 0-∞ ) was similar for fed (440.6 ng · h/ml) vs. fasted conditions (395.1 ng · h/ml).,"[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Kinzler', 'Affiliation': 'Inspirion Delivery Sciences, LLC, Morristown, NJ, USA. eric.kinzler@inspirionrx.com.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pantaleon', 'Affiliation': 'Inspirion Delivery Sciences, LLC, Morristown, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Iverson', 'Affiliation': 'Inspirion Delivery Sciences, LLC, Morristown, NJ, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Aigner', 'Affiliation': 'Inspirion Delivery Sciences, LLC, Morristown, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-019-01022-4'] 475,31278695,"Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial.","INTRODUCTION Magnetic resonance imaging (MRI) is increasingly used in patients with rheumatoid arthritis (RA) to determine residual inflammation after treatment and as a predictor of structural damage progression. Establishing an optimal threshold of inflammatory activity that predicts lower risk of structural damage progression may inform treatment decisions. This post hoc analysis investigated whether patients with RA at low risk of structural damage progression can be identified based on MRI inflammation thresholds. METHODS Hand and wrist MRI was performed at baseline, and at months 6 and 12 in a phase 3b, randomized, active-controlled, double-blind trial of abatacept in early RA (AVERT). Pathologies were scored using the OMERACT RA MRI Score. Data were stratified into two risk subgroups (less and more severe inflammation) for structural damage progression (erosion change > 0.5) based on baseline inflammation. In this post hoc analysis, log odds ratios of probability of progression {adjusted for baseline Disease Activity Score in 28 joints [C-reactive protein; DAS28 (CRP)]} were compared between subgroups to test the performance of inflammation thresholds. RESULTS There were 351 randomized and treated patients with baseline MRIs, of whom 276 (78.6%) and 235 (67.0%) had MRIs available at months 6 and 12, respectively. The DAS28 (CRP)-adjusted probabilities of progression from baseline to month 12 based on scores at baseline, and from months 6 to 12 based on month 6 scores, were significantly lower among patients with less inflammation (P < 0.0001-0.0459), independent of clinical disease activity. Predefined thresholds of synovitis ≤ 3 (total score 21), osteitis ≤ 3 (total score 69) and total inflammation score (osteitis double-weighted) ≤ 9 were associated with a lower likelihood of structural damage progression in unadjusted analyses. CONCLUSION Levels of MRI-determined inflammatory activity below defined thresholds were independently associated with a lower risk of structural damage progression in early RA, providing a potential trial endpoint for levels of inflammation not associated with progression. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01142726. FUNDING Bristol-Myers Squibb.",2019,"Levels of MRI-determined inflammatory activity below defined thresholds were independently associated with a lower risk of structural damage progression in early RA, providing a potential trial endpoint for levels of inflammation not associated with progression. ",['patients with rheumatoid arthritis (RA'],"['Placebo', 'Magnetic resonance imaging (MRI']","['osteitis\u2009≤\u20093 (total score 69) and total inflammation score', 'Levels of MRI-determined inflammatory activity', 'DAS28 (CRP)-adjusted probabilities of progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0029400', 'cui_str': 'Bone Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",351.0,0.273706,"Levels of MRI-determined inflammatory activity below defined thresholds were independently associated with a lower risk of structural damage progression in early RA, providing a potential trial endpoint for levels of inflammation not associated with progression. ","[{'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA. harris.ahmad@bms.com.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Baker', 'Affiliation': 'Philadelphia VA Medical Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]",Advances in therapy,['10.1007/s12325-019-01020-6'] 476,30946442,Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.,"Importance Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage. Objective To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children. Design, Setting, and Participants A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington). A total of 1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery). Of these, 1091 were excluded because they did not meet eligibility criteria (n = 681) or refused to participate (n = 410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017. Interventions Participants were randomized to receive ibuprofen, 10 mg/kg (n = 372), or acetaminophen, 15 mg/kg (n = 369), every 6 hours for the first 9 postoperative days. Main Outcomes and Measures Rate and severity of posttonsillectomy bleeding were recorded using a postoperative bleeding severity scale: type 1 (bleeds that were observed at home or evaluated in the emergency department without further intervention), type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage). Type 3 bleeding was the main outcome measure. The noninferiority margin was set at 3%, and modified intention-to-treat analysis was used. Results Of the 741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5 [4] years; 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis. The rate of bleeding requiring operative intervention was 1.2% in the acetaminophen group and 2.9% in the ibuprofen group (difference, 1.7%; 97.5% CI upper limit, 3.8%; P = .12 for noninferiority). There were no significant adverse events or deaths. Conclusions and Relevance This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy. This finding should be considered when selecting a postoperative analgesic regimen. Further studies are needed to understand if bleeding risk is affected when ibuprofen is used for a shorter duration or in combination with acetaminophen for postoperative analgesia. Trial Registration ClinicalTrials.gov identifier: NCT01605903.",2019,This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy.,"['children', 'children receiving', '1091 were excluded because they did not meet eligibility criteria (n\u2009=\u2009681) or refused to participate (n\u2009=\u2009410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017', ' 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis', '1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery', '741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5 [4] years', '4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington', 'After Pediatric Tonsillectomy']","['Ibuprofen vs Acetaminophen', 'ibuprofen', 'acetaminophen', 'Ibuprofen', 'tonsillectomy alone or tonsillectomy with adenoidectomy']","['adverse events or deaths', 'type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage', 'Severe Bleeding Risk', 'rate of bleeding requiring operative intervention', 'postoperative bleeding severity scale: type 1 (bleeds', 'Measures\n\n\nRate and severity of posttonsillectomy bleeding']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040425', 'cui_str': 'Tonsillitis'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305419', 'cui_str': 'Complication of tonsil surgery with bleeding'}]",741.0,0.273179,This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy.,"[{'ForeName': 'Gillian R', 'Initials': 'GR', 'LastName': 'Diercks', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Comins', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting Inc, Ballston Lake, New York.'}, {'ForeName': 'Thomas Q', 'Initials': 'TQ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center Portsmouth, Portsmouth, Virginia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brigger', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boseley', 'Affiliation': 'Department of Otolaryngology, Madigan Army Medical Center, Tacoma, Washington.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Gaudreau', 'Affiliation': 'Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rogers', 'Affiliation': 'Department of Otolaryngology, Madigan Army Medical Center, Tacoma, Washington.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Setlur', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Keamy', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hartnick', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0269'] 477,31316148,Renal function in small for gestational age preterm infants.,"OBJECTIVE The objective of this study is to compare glomerular and tubular functions in small for gestational age (SGA) and appropriate for gestational age (AGA) preterm infants. STUDY DESIGN A prospective controlled study was conducted on SGA and AGA infants with gestational ages between 32 0/7 and 36 6/7 weeks, who received gentamycin in the first 72 h of life. Glomerular and tubular functions were assessed on days 1 and 5. RESULTS Fifty (25 SGA and 25 AGA) infants were included. On day of life 1, SGA group had higher serum sodium, serum urea, and urinary creatinine. On day 5, SGA infants had significant increase in serum creatinine (p = 0.04). Urinary NAG and FeNa were comparable among the two groups on days 1 and 5. CONCLUSIONS Glomerular functions were compromised in SGA preterm infants. Tubular functions were comparable.",2019,"On day 5, SGA infants had significant increase in serum creatinine (p = 0.04).","['SGA preterm infants', 'SGA and AGA infants with gestational ages between 32 0/7 and 36 6/7 weeks, who received gentamycin in the first 72\u2009h of life', 'gestational age preterm infants', 'small for gestational age (SGA) and appropriate for gestational age (AGA) preterm infants', 'Fifty']",[],"['glomerular and tubular functions', 'Tubular functions', 'Urinary NAG and FeNa', 'Renal function', 'serum creatinine', 'serum sodium, serum urea, and urinary creatinine', 'Glomerular and tubular functions']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]",[],"[{'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",25.0,0.0302687,"On day 5, SGA infants had significant increase in serum creatinine (p = 0.04).","[{'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Aly', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's hospital, Cleveland, OH, USA. alyh@ccf.org.""}, {'ForeName': 'Zahraa', 'Initials': 'Z', 'LastName': 'Ez El Din', 'Affiliation': 'Department of Pediatrics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Reem M', 'Initials': 'RM', 'LastName': 'Soliman', 'Affiliation': 'Department of Pediatrics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Bhattacharjee', 'Affiliation': ""Department of Neonatology, Cleveland Clinic Children's hospital, Cleveland, OH, USA.""}, {'ForeName': 'May A K', 'Initials': 'MAK', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Pediatrics, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdelkarim', 'Initials': 'A', 'LastName': 'Kamel', 'Affiliation': 'Department of Medical Biochemistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Salah', 'Affiliation': 'Air Forced Army Hospital, Cairo, Egypt.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0431-9'] 478,32240018,Greater lactate accumulation following an acute bout of high-intensity exercise in males suppresses acylated ghrelin and appetite postexercise.,"High-intensity exercise inhibits appetite, in part, via alterations in the peripheral concentrations of the appetite-regulating hormones acylated ghrelin, active glucagon-like peptide-1 (GLP-1), and active peptide tyrosine-tyrosine (PYY). Given lactate may mediate these effects, we used sodium bicarbonate (NaHCO 3 ) supplementation in a double-blind, placebo-controlled, crossover design to investigate lactate's purported role in exercise-induced appetite suppression. Eleven males completed two identical high-intensity interval training sessions (10 × 1 min cycling bouts at ~90% heart rate maximum interspersed with 1-min recovery), where they ingested either NaHCO 3 (BICARB) or sodium chloride (NaCl) as a placebo (PLACEBO) preexercise. Blood lactate, acylated ghrelin, GLP-1, and PYY concentrations, as well as overall appetite were assessed preexercise and 0, 30, 60, and 90 min postexercise. Blood lactate was greater immediately ( P < 0.001) and 30 min postexercise ( P = 0.049) in the BICARB session with an increased ( P = 0.009) area under the curve (AUC). The BICARB session had lower acylated ghrelin at 60 ( P = 0.014) and 90 min postexercise ( P = 0.016), with a decreased AUC ( P = 0.039). The BICARB session had increased PYY ( P = 0.034) with an increased AUC ( P = 0.031). The BICARB session also tended ( P = 0.060) to have increased GLP-1 at 30 ( P = 0.003) and 60 min postexercise ( P < 0.001), with an increased AUC ( P = 0.030). The BICARB session tended ( P = 0.059) to reduce overall appetite, although there was no difference in AUC ( P = 0.149). These findings support a potential role for lactate in the high-intensity exercise-induced appetite-suppression. NEW & NOTEWORTHY We used sodium bicarbonate to increase lactate accumulation or sodium chloride as a placebo. Our findings further implicate lactate as a mediator of exercise-induced appetite suppression, given exercise-induced increases in lactate during the sodium bicarbonate session altered peripheral concentrations of appetite-regulating hormones, culminating in a reduction of appetite. This supports a lactate-dependent mechanism of appetite suppression following high-intensity exercise and highlights the potential of using lactate as a means of inducing a caloric deficit.",2020,"High-intensity exercise inhibits appetite in part via alterations in the peripheral concentrations of the appetite-regulating hormones acylated ghrelin, active glucagon-like peptide-1",['Eleven males completed two'],"['identical high-intensity interval training sessions (10 x 1 min cycling bouts at ~90% heart rate maximum interspersed with 1 min recovery), where they ingested either NaHCO 3 (BICARB) or sodium chloride (NaCl) as a placebo (PLACEBO) pre-exercise', 'High-intensity exercise', 'sodium bicarbonate (NaHCO 3 ) supplementation']","['Blood lactate', 'overall appetite', 'BICARB session with an increased (P=0.009) area under the curve (AUC', 'Greater lactate accumulation', 'Blood lactate, acylated ghrelin, GLP-1, and PYY concentrations, as well as overall appetite', 'GLP-1']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.204656,"High-intensity exercise inhibits appetite in part via alterations in the peripheral concentrations of the appetite-regulating hormones acylated ghrelin, active glucagon-like peptide-1","[{'ForeName': 'Luke W', 'Initials': 'LW', 'LastName': 'Vanderheyden', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Greg L', 'Initials': 'GL', 'LastName': 'McKie', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Howe', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Hazell', 'Affiliation': 'Department of Kinesiology and Physical Education, Wilfrid Laurier University, Waterloo, Ontario, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00081.2020'] 479,32243717,Results from a randomized controlled trial testing StressProffen; an application-based stress-management intervention for cancer survivors.,"BACKGROUND In-person cognitive-behavioral stress-management interventions are consistently associated with reduced cancer distress. However, face-to-face delivery is an access barrier for many patients, and there is a need to develop remote-delivered interventions. The current study evaluated the preliminary efficacy of an application (app)-based cancer stress-management intervention, StressProffen, in a randomized controlled trial. METHODS Cancer survivors, maximum 1-year posttreatment (N = 172), were randomized to StressProffen (n = 84) or a usual care control group (n = 88). Participants received a blended delivery care model: (a) one face-to-face introduction session, (b) 10 app-based cognitive-behavioral stress-management modules, and (c) follow-up phone calls at weeks 2-3 and 6-7. Outcome measures included stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety Depression Scale), and health-related quality of life (HRQoL; Short-Form Health Surveys [SF-36]) at 3-months post-intervention, analyzed with change scores as dependent variables in linear regression models. RESULTS Participants were primarily women (82%), aged 20-78 years (mean 52, SD 11.2), with mixed cancer types (majority breast cancer; 48%). Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD] -2.8; 95% confidence interval [CI], [-5.2 to -0.4]; P = .022) and improved HRQoL (Role Physical MD = 17.7, [CI 3.7-31.3], P = .013; Social Functioning MD = 8.5, [CI 0.7-16.2], P = .034; Role Emotional MD = 19.5, [CI 3.7-35.2], P = .016; Mental Health MD = 6.7, [CI 1.7-11.6], P = .009). No significant changes were observed for anxiety or depression. CONCLUSIONS Digital-based cancer stress-management interventions, such as StressProffen, have the potential to provide easily accessible, effective psychosocial support for cancer survivors.",2020,Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD],"['Participants were primarily women (82%), aged 20-78\xa0years (mean 52, SD 11.2), with mixed cancer types (majority breast cancer; 48', 'cancer survivors', 'Cancer survivors, maximum 1-year posttreatment (N\xa0=\xa0172']","['application (app)-based cancer stress-management intervention, StressProffen', 'usual care control group', 'StressProffen', 'blended delivery care model: (a) one face-to-face introduction session, (b) 10 app-based cognitive-behavioral stress-management modules, and (c) follow-up phone calls at weeks 2-3 and 6-7']","['HRQoL', 'stress (mean difference [MD', 'stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety Depression Scale), and health-related quality of life (HRQoL; Short-Form Health Surveys [SF-36', 'anxiety or depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517601', 'cui_str': '172'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0451107', 'cui_str': 'Depression anxiety scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.0981584,Analysis of 149 participants completing questionnaires at baseline and 3 months revealed significant intervention effects: decreased stress (mean difference [MD],"[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Børøsund', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Shawna L', 'Initials': 'SL', 'LastName': 'Ehlers', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Varsi', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Andrykowski', 'Affiliation': 'Department of Behavioral Science, College of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Solberg Nes', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",Cancer medicine,['10.1002/cam4.3000'] 480,31301057,Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial.,"INTRODUCTION Core stability exercises and treadmill training play a crucial role in physical therapy interventions and have an effect on balance in children with Down Syndrome (DS); however, whether core stability exercises or treadmill training has more effect on improving balance has not been investigated yet. The aim of the study was to investigate the effect of core stability training versus treadmill exercises on balance in children with Down Syndrome. METHODS Forty-five children aged 4-6 years with Down Syndrome were included in the study. The children were equally divided randomly into three groups. Group A received traditional physical therapy intervention strategies to facilitate the balance of participating children. Group B received the same as group A and additional core stability exercise training. Group C received the same intervention strategies as group A in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg balance scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for 8 consecutive weeks. RESULTS There were significance improvements in the three groups in functional balance and over all stability indices in favor of groups B and C. CONCLUSIONS Core stability and treadmill training improved balance in children with Down Syndrome and should be applied in conjunction with physical therapy programs.",2019,"There were significance improvements in the three groups in functional balance and over all stability indices in favor of groups B and C. CONCLUSIONS Core stability and treadmill training improved balance in children with Down Syndrome and should be applied in conjunction with physical therapy programs.","['children with Down Syndrome (DS', 'children with Down Syndrome', 'Children with Down Syndrome', 'Forty-five children aged 4-6\xa0years with Down Syndrome were included in the study']","['Core stability exercises and treadmill training', 'additional core stability exercise training', 'traditional physical therapy intervention strategies', 'core stability training versus treadmill exercises', 'same intervention strategies as group A in conjunction with a treadmill exercise program', 'stability exercises or treadmill training', 'Core Stability Exercises and Treadmill Training']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]",[],45.0,0.0330614,"There were significance improvements in the three groups in functional balance and over all stability indices in favor of groups B and C. CONCLUSIONS Core stability and treadmill training improved balance in children with Down Syndrome and should be applied in conjunction with physical therapy programs.","[{'ForeName': 'Reham Saeed', 'Initials': 'RS', 'LastName': 'Alsakhawi', 'Affiliation': 'The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt. rsm211_pt@yahoo.com.'}, {'ForeName': 'Mohamed Ali', 'Initials': 'MA', 'LastName': 'Elshafey', 'Affiliation': 'The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Advances in therapy,['10.1007/s12325-019-01024-2'] 481,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8'] 482,32240629,Once-weekly rifapentine and isoniazid for tuberculosis prevention in patients with HIV taking dolutegravir-based antiretroviral therapy: a phase 1/2 trial.,"BACKGROUND Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-negative adults was halted early after two of the four patients developed serious adverse events. Because of the potential use of this therapy, and variable safety outcomes of tuberculosis drugs seen in patients with and without HIV, we aimed to characterise safety, pharmacokinetics, and virological suppression in adults who are HIV positive. METHODS DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa). Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of efavirenz-based or dolutegravir-based regimens were recruited in three consecutive groups, subject to approval by the independent safety monitoring committee. Participants received 50 mg of daily dolutegravir in place of efavirenz for 8 weeks, then began once-weekly rifapentine (900 mg)-isoniazid (900 mg) for 12 weeks. Groups 1A (n=12) and 1B (n=18) had intensive dolutegravir pharmacokinetic sampling at week 8 (before rifapentine-isoniazid), at week 11 (after the third dose of rifapentine)-isoniazid and at week 16 after the eighth dose. Group 2 (n=30) were treated with the same schedule and had sparse dolutegravir pharmacokinetic sampling at weeks 8, 11, and 16. Participants were followed 4 weeks after completion of prophylactic tuberculosis treatment. HIV viral loads were measured at baseline and at weeks 11 and 24. Primary endpoints were adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics, assessed in participants who began rifapentine-isoniazid. This trial was registered at ClinicalTrials.gov, NCT03435146. FINDINGS Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A). 43 (70%) of 60 participants were women and all participants were black African. Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2 (24·0-32·9). Three grade 3 adverse events occurred; two elevated creatinine and one hypertension. Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve. Overall geometric mean ratio of trough concentrations with versus without rifapentine-isoniazid was 0·53 (90% CI 0·49-0·56) though this ratio varied by day after rifapentine-isoniazid dose. All but one trough value was above the 90% maximal inhibitory concentration for dolutegravir and HIV viral loads were less than 40 copies per mL in all patients. INTERPRETATION Our results suggest 12 doses of once-weekly rifapentine-isoniazid can be given for tuberculosis prophylaxis to patients with HIV taking dolutegravir-based antiretroviral therapy, without dose adjustments. Further exploration of the pharmacokinetics, safety, and efficacy in children and pharmacodynamics in individuals naive to antiretroviral therapy is needed. FUNDING UNITAID.",2020,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"['43 (70%) of 60 participants were women and all participants were black African', 'patients with HIV taking dolutegravir-based antiretroviral therapy', 'Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of', 'Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2 (24·0-32·9', 'DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa', 'adults who are HIV positive', 'Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A', 'children and pharmacodynamics in individuals naive to antiretroviral therapy', 'patients with and without HIV', 'areas with high co-endemicity with HIV']","['Rifapentine-isoniazid', 'daily dolutegravir in place of efavirenz', 'rifapentine-isoniazid', 'rifapentine and isoniazid', 'rifapentine', 'isoniazid', 'efavirenz-based or dolutegravir-based regimens', 'rifapentine)-isoniazid']","['dolutegravir and HIV viral loads', 'dolutegravir clearance', 'Overall geometric mean ratio of trough concentrations', 'dolutegravir area', 'intensive dolutegravir pharmacokinetic sampling', 'HIV viral loads', 'adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics', 'serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0441862', 'cui_str': 'Group 1A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",61.0,0.385174,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Radojkam', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Gupte', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vinodh A', 'Initials': 'VA', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wolf', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Modulakgotla', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Morongwe', 'Initials': 'M', 'LastName': 'Likoti', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Fyvie', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Shibambo', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Beattie', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Churchyard', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30032-1'] 483,32245569,"Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial.","BACKGROUND This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS In a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg -1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals. RESULTS The analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L -1 [-5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups. CONCLUSIONS These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery. CLINICAL TRIAL REGISTRATION ISRCTN18386427.",2020,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","['60 subjects in the sildenafil group and 69 in the placebo control group', 'acute kidney injury undergoing cardiac surgery in a single UK tertiary centre', 'at-risk patients undergoing cardiac surgery with cardiopulmonary bypass', 'and post-cardiac surgery acute kidney injury']","['dextrose', 'placebo', 'valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass', 'Intravenous sildenafil citrate', 'sildenafil citrate', 'sildenafil']","['serum creatinine', 'clinical events and potential disease mechanisms', 'acute kidney injury', 'creatinine concentration', 'biomarkers of kidney injury, endothelial function, and inflammatory cell activation', 'glomerular filtration rate, and surgical procedure', 'multiple organ dysfunction scores']","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1960439', 'cui_str': 'Multiple organ dysfunction score'}]",,0.802905,"There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Hardeep', 'Initials': 'H', 'LastName': 'Aujla', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Woźniak', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Dott', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Nikol', 'Initials': 'N', 'LastName': 'Sullo', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Lathishia', 'Initials': 'L', 'LastName': 'Joel-David', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Smallwood', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; School of Allied Health Sciences, De Montfort University, Leicester, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Eagle-Hemming', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.'}, {'ForeName': 'Ana Suazo', 'Initials': 'AS', 'LastName': 'Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Brunskill', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; Leicester Clinical Trials Unit, University of Leicester, Leicester, UK. Electronic address: gjm19@le.ac.uk.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.01.030'] 484,31301054,Evaluating the Effects of an Ophthalmic Solution of Coenzyme Q10 and Vitamin E in Open-Angle Glaucoma Patients: A Study Protocol.,"INTRODUCTION The CoQun ® study is a multicenter, controlled trial aimed to evaluate the neuroprotective effects of Coqun ® , an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE), in patients affected by primary open-angle glaucoma (POAG). Pre-clinical studies and small non-controlled clinical trials have previously shown a potential role of CoQ10 and VitE in glaucoma neuroprotection, both in vitro and in vivo. METHODS Randomized, parallel arm, multicenter, double-blind study. POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment. Inclusion criteria will be visual field (VF) mean deviation between - 4 and - 10 dB and VF Pattern Standard Deviation between 4 and 10 dB. Eligible patients will be randomized to receive CoQun ® (Arm A) or placebo (Arm B), in addition to PGA monotherapy. PLANNED OUTCOMES Primary outcome will be time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression. A total of 612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided). For study power calculation, 10% non-evaluable patients are assumed. This is the first study investigating, in a randomized, double-blind and controlled fashion, the neuroprotective effects of CoQ10 and VitE in POAG patients. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03611530.",2019,POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment.,"['POAG patients', 'patients affected by primary open-angle glaucoma (POAG', 'POAG patients with an IOP ranging from 17 to 21\xa0mm Hg on monotherapy with a', 'Open-Angle Glaucoma Patients', '612 patients are planned to be enrolled, to detect a hazard ratio of 0.65, with a power of 80% and an alpha error of 0.05 (two-sided', 'Inclusion criteria will be visual field (VF) mean deviation between -\xa04 and -\xa010\xa0dB and VF Pattern Standard Deviation between 4 and 10\xa0dB. Eligible patients']","['prostaglandin analogue (PGA', 'Coqun ® , an ophthalmic solution of Coenzyme q10 (CoQ10) and Vitamin E (VitE', 'Ophthalmic Solution of Coenzyme Q10 and Vitamin E', 'CoQun ® (Arm A) or placebo (Arm B), in addition to PGA monotherapy']","['time to progression, defined as the time between the baseline visit and the visit with confirmed VF progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517471', 'cui_str': '0.65'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C1720055', 'cui_str': 'Visual field index - pattern standard deviation'}]","[{'cui': 'C0033568', 'cui_str': 'Prostaglandin Analogs'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]",612.0,0.693539,POAG patients with an IOP ranging from 17 to 21 mm Hg on monotherapy with a prostaglandin analogue (PGA) will be considered for study enrollment.,"[{'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Quaranta', 'Affiliation': 'Department of Surgical & Clinical, Diagnostic and Pediatric Sciences, Section of Ophthalmology, University of Pavia, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy. luciano.quaranta@unipv.it.'}, {'ForeName': 'Ivano', 'Initials': 'I', 'LastName': 'Riva', 'Affiliation': 'IRCCS - Fondazione Bietti, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Legramandi', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-019-01023-3'] 485,32006006,Live-Attenuated Respiratory Syncytial Virus Vaccine With M2-2 Deletion and With Small Hydrophobic Noncoding Region Is Highly Immunogenic in Children.,"BACKGROUND Respiratory syncytial virus (RSV) is the leading viral cause of severe pediatric respiratory illness, and vaccines are needed. Live RSV vaccine D46/NS2/N/ΔM2-2-HindIII, attenuated by deletion of the RSV RNA regulatory protein M2-2, is based on previous candidate LID/ΔM2-2 but incorporates prominent differences from MEDI/ΔM2-2, which was more restricted in replication in phase 1. METHODS RSV-seronegative children aged 6-24 months received 1 intranasal dose (105 plaque-forming units [PFUs] of D46/NS2/N/ΔM2-2-HindIII [n = 21] or placebo [n = 11]) and were monitored for vaccine shedding, reactogenicity, RSV-antibody responses and RSV-associated medically attended acute respiratory illness (RSV-MAARI) and antibody responses during the following RSV season. RESULTS All 21 vaccinees were infected with vaccine; 20 (95%) shed vaccine (median peak titer, 3.5 log10 PFUs/mL with immunoplaque assay and 6.1 log10 copies/mL with polymerase chain reaction). Serum RSV-neutralizing antibodies and anti-RSV fusion immunoglobulin G increased ≥4-fold in 95% and 100% of vaccines, respectively. Mild upper respiratory tract symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%). Over the RSV season, RSV-MAARI occurred in 2 vaccinees and 4 placebo recipients. Three vaccinees had ≥4-fold increases in serum RSV-neutralizing antibody titers after the RSV season without RSV-MAARI. CONCLUSIONS D46/NS2/N/ΔM2-2-HindIII had excellent infectivity and immunogenicity and primed vaccine recipients for anamnestic responses, encouraging further evaluation of this attenuation strategy. CLINICAL TRIALS REGISTRATION NCT03102034 and NCT03099291.",2020,Mild upper respiratory symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%).,"['children', 'RSV-seronegative children ages 6-24 months received one']","['vaccine', 'placebo', 'intranasal dose [105 plaque forming units (PFU)] of D46/NS2/N/ΔM2-2-HindIII (n=21) or placebo (n=11) (NCT03102034/NCT03099291']","['Mild upper respiratory symptoms and/or fever', 'vaccine shedding, reactogenicity, RSV-antibody responses and RSV-associated medically-attended acute respiratory illness (RSV-MAARI) and antibody responses', 'Serum RSV-neutralizing antibodies and anti-RSV F IgG', 'RSV season, RSV-MAARI', 'serum RSV-neutralizing antibody titers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0749874', 'cui_str': 'Upper respiratory symptom'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.193906,Mild upper respiratory symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%).,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'McFarland', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Petronella', 'Initials': 'P', 'LastName': 'Muresan', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health/Frontier Science Foundation, Boston, Massachusetts, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Perlowski', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Libous', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Oliva', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jean-Philippe', 'Affiliation': 'Maternal, Adolescent and Pediatric Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schappell', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Rexroad', 'Affiliation': 'Investigational Drug Service Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fearn', 'Affiliation': ""Department of Pediatrics, Northwestern University Medical School and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Mikhaela', 'Initials': 'M', 'LastName': 'Cielo', 'Affiliation': 'Division of Infectious Diseases, Maternal Child & Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wiznia', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine and Jacobi Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Jaime G', 'Initials': 'JG', 'LastName': 'Deville', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, California, USA.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Luongo', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Collins', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Ursula J', 'Initials': 'UJ', 'LastName': 'Buchholz', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa049'] 486,32145713,Combined non-intubated anaesthesia and paravertebral nerve block in comparison with intubated anaesthesia in children undergoing video-assisted thoracic surgery.,"BACKGROUND This study is to investigate if non-intubated anaesthesia combined with paravertebral nerve block (PVNB) can enhance recovery in children undergoing video-assisted thoracic surgery (VATS). METHODS A randomized controlled trial including 60 patients aged 3 to 8 years old who underwent elective VATS was performed. They were randomly assigned to receive non-intubated anaesthesia combined with PVNB or general anaesthesia with tracheal intubation (1:1 ratio). The primary outcome was the length of postoperative in-hospital stay. The secondary outcomes included emergence time, the incidence of emergence delirium, time to first feeding, time to first out-of-bed activity, pain score and in-hospital complications. RESULTS The non-intubated group had shorter postoperative in-hospital stay than the control group (4 days [IQR, 4-6] vs 5 days [IQR, 5-8], 95% CI 0-2; P = .013). When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01-11.41; P = .043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group. In contrast, the incidence of airway complications was higher in the control than the intervention group (27.6% vs 6.9%, P = .037). There was no statistical significance in the occurrence of PONV, pneumothorax and other complications between the two groups. CONCLUSIONS Non-intubated anaesthesia combined with PVNB enhances recovery in paediatric patients for video-assisted thoracic surgery although further multi-centre study is needed.",2020,"When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01 - 11.41; P = 0.043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group.","['paediatric patients', '60 patients aged 3 to 8 years old who underwent elective VATS was performed', 'children undergoing video-assisted thoracic surgery (VATS', 'children undergoing video-assisted thoracic surgery']","['PVNB', 'Combined non-intubated anaesthesia and paravertebral nerve block', 'non-intubated anaesthesia combined with PVNB or general anaesthesia with tracheal intubation (1:1 ratio', 'intubated anaesthesia', 'intubated anaesthesia combined with paravertebral nerve block (PVNB']","['occurrence of PONV, pneumothorax and other complications', 'incidence of airway complications', 'shorter postoperative in-hospital stay', 'emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil', 'emergence time, the incidence of emergence delirium, time to first feeding, time to first out-of-bed activity, pain score and in-hospital complications', 'length of postoperative in-hospital stay', 'incidence of emergence delirium']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia (procedure)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",60.0,0.135181,"When compared to the control group, the incidence of emergence delirium (odds ratio [OR] 3.39, 95% CI 1.01 - 11.41; P = 0.043), emergence time, duration in the PACU, time to first eating food, first out-of-bed activity, pain score and consumption of sufentanil (at 6 and 12 hours after surgery) were decreased in the intervention group.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Tianyun', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yingyi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xingrong', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Anaesthesiology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Anaethetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13572'] 487,31826731,Neuroimaging in Ischemic Stroke Is Different Between Men and Women in the DEFUSE 3 Cohort.,"Background and Purpose- Clinical deficits from ischemic stroke are more severe in women, but the pathophysiological basis of this sex difference is unknown. Sex differences in core and penumbral volumes and their relation to outcome were assessed in this substudy of the DEFUSE 3 clinical trial (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke). Methods- DEFUSE 3 randomized patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging. Using univariate and adjusted regression models, the effect of sex was assessed on prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans. Results- All patients were included in the analysis (n=182) with 90 men and 92 women. There was no sex difference in the site of baseline arterial occlusion. Adjusted by age, baseline National Institutes of Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes than men. Median (interquartile range) volumes for core were 8.0 mL (1.9-18.4) in women versus 12.6 mL (2.7-29.6) in men, for T max >6 seconds 89.0 mL (63.8-131.7) versus 133.9 mL (87.0-175.4), and for mismatch 82.1mL (53.8-112.8) versus 108.2 (64.1-149.2). The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003). Conclusions- In the large vessel ischemic stroke cohort selected for DEFUSE 3, women had imaging evidence of better collateral circulation, smaller baseline core volumes, and slower ischemic core growth. These observations suggest sex differences in hemodynamic and temporal features of anterior circulation large artery occlusions. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2020,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","['All patients were included in the analysis (n=182) with 90 men and 92 women', 'Men and Women in the DEFUSE 3 Cohort', 'patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging']","[' and Purpose', 'Conclusions', 'Methods']","['prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans', 'Median (interquartile range) volumes', 'Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes', 'hypoperfusion intensity ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1275506', 'cui_str': 'Imaging modality'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",182.0,0.369744,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","[{'ForeName': 'Adrienne N', 'Initials': 'AN', 'LastName': 'Dula', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Zuck', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028205'] 488,30795852,Increased production and reduced urinary buffering of acid in uric acid stone formers is ameliorated by pioglitazone.,"Idiopathic uric acid nephrolithiasis is characterized by an overly acidic urine pH caused by the combination of increased acid production and inadequate buffering of urinary protons by ammonia. A large proportion of uric acid stone formers exhibit features of the metabolic syndrome. We previously demonstrated that thiazolidinediones improved the urinary biochemical profile in an animal model of the metabolic syndrome. In this proof-of-concept study, we examined whether the thiazolidinedione pioglitazone can also ameliorate the overly acidic urine in uric acid stone formers. Thirty-six adults with idiopathic uric acid nephrolithiasis were randomized to pioglitazone 30 mg/day or matching placebo for 24 weeks. At baseline and study end, participants underwent collection of blood and 24-hour urine in an inpatient research unit while consuming a fixed metabolic diet, followed by assessment of the ammoniagenic response to an acute oral acid load. Twenty-eight participants completed the study. Pioglitazone treatment improved features of the metabolic syndrome. Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo. Treatment of patients with idiopathic uric acid nephrolithiasis with pioglitazone for 24 weeks led to a reduction in the acid load presented to the kidney and a more robust ammoniagenesis and ammonium excretion, resulting in significantly higher urine pH. Future studies should consider the impact of this targeted therapy on uric acid stone formation.",2019,"Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo.","['patients with idiopathic uric acid nephrolithiasis with', 'Thirty-six adults with idiopathic uric acid nephrolithiasis', 'Twenty-eight participants completed the study']","['thiazolidinedione pioglitazone', 'Pioglitazone', 'placebo', 'pioglitazone', 'pioglitazone 30 mg/day or matching placebo', 'thiazolidinediones']","['metabolic syndrome', 'net acid excretion and increased urine pH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0558595', 'cui_str': 'Uric acid renal calculus (disorder)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1127433', 'cui_str': 'pioglitazone 30 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test (procedure)'}]",36.0,0.0409921,"Pioglitazone also reduced net acid excretion and increased urine pH (5.37 to 5.59), the proportion of net acid excreted as ammonium, and ammonium excretion in response to an acute acid load, whereas these parameters were unchanged with placebo.","[{'ForeName': 'Naim M', 'Initials': 'NM', 'LastName': 'Maalouf', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Poindexter', 'Affiliation': 'Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Department of Physiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Sakhaee', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, Texas, USA. Electronic address: Khashayar.sakhaee@utsouthwestern.edu.'}]",Kidney international,['10.1016/j.kint.2018.11.024'] 489,31633896,Metoprolol for the Prevention of Acute Exacerbations of COPD.,"BACKGROUND Observational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials. METHODS In this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. The primary end point was the time until the first exacerbation of COPD during the treatment period, which ranged from 336 to 350 days, depending on the adjusted dose of metoprolol. RESULTS A total of 532 patients underwent randomization. The mean (±SD) age of the patients was 65.0±7.8 years; the mean forced expiratory volume in 1 second (FEV 1 ) was 41.1±16.3% of the predicted value. The trial was stopped early because of futility with respect to the primary end point and safety concerns. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days in the metoprolol group and 222 days in the placebo group (hazard ratio for metoprolol vs. placebo, 1.05; 95% confidence interval [CI], 0.84 to 1.32; P = 0.66). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). The frequency of side effects that were possibly related to metoprolol was similar in the two groups, as was the overall rate of nonrespiratory serious adverse events. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group. CONCLUSIONS Among patients with moderate or severe COPD who did not have an established indication for beta-blocker use, the time until the first COPD exacerbation was similar in the metoprolol group and the placebo group. Hospitalization for exacerbation was more common among the patients treated with metoprolol. (Funded by the Department of Defense; BLOCK COPD ClinicalTrials.gov number, NCT02587351.).",2019,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","['532 patients underwent randomization', 'patients between the ages of 40 and 85 years who had COPD to receive either a', 'patients who were already taking a beta-blocker or who had an established indication for the use of such drugs', 'patients with moderate or severe chronic obstructive pulmonary disease (COPD', 'Acute Exacerbations of COPD', 'patients with moderate or severe COPD']","['beta-blocker (extended-release metoprolol) or placebo', 'beta-blockers', 'placebo', 'metoprolol', 'metoprolol vs. placebo', 'Metoprolol']","['median time until the first exacerbation', 'frequency of side effects', 'time until the first COPD exacerbation', 'risk of exacerbations', 'time until the first exacerbation of COPD', 'Hospitalization for exacerbation', 'overall rate of nonrespiratory serious adverse events', 'mean forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",532.0,0.447618,"Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83).","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Voelker', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Brenner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Come', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Allen D', 'Initials': 'JAD', 'LastName': 'Cooper', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Curtis', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Hatipoğlu', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Erika S', 'Initials': 'ES', 'LastName': 'Helgeson', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Vipul V', 'Initials': 'VV', 'LastName': 'Jain', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Kalhan', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaminsky', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kaner', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ken M', 'Initials': 'KM', 'LastName': 'Kunisaki', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Lambert', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Lammi', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lindberg', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Make', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'McEvoy', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reed', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Scanlon', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Peruvemba S', 'Initials': 'PS', 'LastName': 'Sriram', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stringer', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wells', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Westfall', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': ""From the Lung Health Center, University of Alabama at Birmingham (M.T.D., S.P.B., J.M.W., E.W.), and Birmingham Veterans Affairs (VA) Medical Center (M.T.D., J.A.D.C., J.M.W.) - both in Birmingham; the University of Minnesota (H.V., E.S.H., S.L., J.E.C.) and the Minneapolis VA Medical Center (K.M.K.), Minneapolis, HealthPartners Minnesota, Bloomington (C.M.), and Mayo Clinic, Rochester (P.D.S.) - all in Minnesota; New York-Presbyterian (NYP)-Columbia University Medical Center (K.B.), NYP-Weill Cornell Medical Center (R. Kaner, F.J.M.), NYP-Queens Medical Center (A.S.), and NYP-Brooklyn Methodist Medical Center (J.A.W.) - all in New York; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles (R.C., W.W.S.), the University of California, San Francisco-Fresno, Fresno (V.V.J.), and the University of California, San Francisco, San Francisco (S.C.L.) - all in California; Brigham and Women's Hospital, Boston (C.E.C.); Temple University School of Medicine, Philadelphia (G.J.C.); the Ann Arbor VA Medical Center (J.L.C.) and the University of Michigan Health System (M.K.H.) - both in Ann Arbor; the Cleveland Clinic, Cleveland (U.H.); Northwestern University, Chicago (R. Kalhan); the University of Vermont, Burlington (D.K.); the University of Washington, Seattle (A.A.L.); Louisiana State University, New Orleans (M.R.L.); National Jewish Health, Denver (B.J.M.); the Cincinnati VA Medical Center, Cincinnati (R.J.P.); the University of Maryland, Baltimore (R.M.R.); the University of Pittsburgh, Pittsburgh (F.C.S.); and North Florida-South Georgia Veterans Health System, Gainesville (P.S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908142'] 490,30942842,Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial.,"Importance Studies have found that patients at high cardiovascular risk often fail to receive evidence-based therapies in community practice. Objective To evaluate whether a multifaceted quality improvement intervention can improve the prescription of evidence-based therapies. Design, Setting, and Participants In this 2-arm cluster randomized clinical trial, patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied. Patients were recruited from August 2016 to August 2017, with follow-up to August 2018. Data were analyzed in September 2018. Interventions Case management, audit and feedback reports, and distribution of educational materials (to health care professionals and patients) vs routine practice. Main Outcomes and Measures The primary end point was prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) using the all-or-none approach at 12 months after the intervention period in patients without contraindications. Results Of the 1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years. Among randomized clusters, 30 (75%) were cardiology sites, 6 (15%) were primary care units, and 26 (65%) were teaching institutions. Among eligible patients, those in intervention clusters were more likely to receive a prescription of evidence-based therapies than those in control clusters (73.5% [515 of 701] vs 58.7% [493 of 840]; odds ratio, 2.30; 95% CI, 1.14-4.65). There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes). Rates of education for smoking cessation were higher among current smokers in the intervention group than in the control group (51.9% [364 of 701] vs 18.2% [153 of 840]; odds ratio, 11.24; 95% CI, 2.20-57.43). The rate of cardiovascular mortality, acute myocardial infarction, and stroke was 2.6% for patients from intervention clusters and 3.4% for those in the control group (hazard ratio, 0.76; 95% CI, 0.43-1.34). Conclusions and Relevance Among Brazilian patients at high cardiovascular risk, a quality improvement intervention resulted in improved prescription of evidence-based therapies. Trial Registration ClinicalTrials.gov identifier: NCT02851732.",2019,"There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes).","['Patients at High Cardiovascular Risk in Brazil', '1619 included patients, 1029 (63.6%) were male, 1327 (82.0%) had coronary artery disease (843 [52.1%] with prior acute myocardial infarction), 355 (21.9%) had prior ischemic stroke or transient ischemic attack, and 197 (12.2%) had peripheral vascular disease, and the mean (SD) age was 65.6 (10.5) years', 'Patients were recruited from August 2016 to August 2017, with follow-up to August 2018', 'Brazilian patients at high cardiovascular risk', 'patients with established atherothrombotic disease from 40 public and private outpatient clinics (clusters) in Brazil were studied']","['Multifaceted Quality Improvement Intervention', 'multifaceted quality improvement intervention']","['Rates of education for smoking cessation', 'rate of cardiovascular mortality, acute myocardial infarction, and stroke', 'risk factor control (ie, hyperlipidemia, hypertension, or diabetes', 'prescription of evidence-based therapies (ie, statins, antiplatelet therapy, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0085096', 'cui_str': 'Peripheral Angiopathies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}]",,0.173161,"There were no differences between the intervention and control groups with regards to risk factor control (ie, hyperlipidemia, hypertension, or diabetes).","[{'ForeName': 'M Julia', 'Initials': 'MJ', 'LastName': 'Machline-Carrion', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Marques', 'Initials': 'RM', 'LastName': 'Soares', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Viviane Bezerra', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Sampaio', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'Federal University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Izar', 'Affiliation': 'Federal University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Amodeo', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Octávio Marques', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana Yamashita', 'Initials': 'JY', 'LastName': 'Santos', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Samara Pinheiro do Carmo', 'Initials': 'SPDC', 'LastName': 'Gomes', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Francisco Kerr', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Hospital e Maternidade Christóvão da Gama, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Pedro Gabriel de Melo', 'Initials': 'PGM', 'LastName': 'Barros E Silva', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nilton', 'Initials': 'N', 'LastName': 'Brandão da Silva', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Hélio Penna', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Piegas', 'Affiliation': 'Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Airton T', 'Initials': 'AT', 'LastName': 'Stein', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.0649'] 491,32171038,"GABAergic modulation of secondary hyperalgesia: A randomized controlled 4-way crossover trial with the α2-subunit preferring GABA positive allosteric modulator, N-desmethyl-clobazam in healthy volunteers.","The antihyperalgesic and sedative effects of the α2-subunit preferring GABA A positive allosteric modulator (GAM), N-desmethyl-clobazam (NDMC), 20 and 60 mg, were assessed in a randomized, placebo and active-controlled (clonazepam 1,5 mg), 4-way crossover study, in healthy volunteers, using the ultraviolet B-induced experimental pain model. Single (20, 40, 60 mg) and repeated doses (20 mg over 15 days) of NDMC pharmacokinetics were evaluated. Thirty-two subjects participated in the study. Primary outcome parameter was maximal change in the area of cutaneous UVB irradiation-induced secondary hyperalgesia (ASH). ASH decreased under all treatments. Mean (SD) relative change was 79 (22)%, 83 (24)%, 77 (30)% and 92 (16)% for placebo, NDMC20, NDMC60 and clonazepam, respectively. Neither absolute change nor relative change in ASH was significantly different between NDMC60 and placebo (mean difference = 2.3 cm 2 [95% CI 4.0-8.5], p = .462 and 0.4% [-11.9 to 12.6], p = .952, respectively). An overall treatment effect was found on level of sedation. Compared to placebo, sedation was higher under clonazepam (mean difference = 39 mm [30-49] on a visual analogue scale, p < .001) while NDMC was free of sedative effect. NDMC pharmacokinetics after single doses showed poor absorption, but was linear. Steady-state plasma concentrations of NDMC20 were attained within 14 days, with low between-subjects variability. Mean steady-state concentration (C S-S , SD) reached 209 (22) ng/ml. NDMC absence of sedative effect and its overall well-characterized safety coming from years of utilization as a metabolite from clobazam, raise the prospect of dose escalating trials in patients to quantify its clinical utility. SIGNIFICANCE: This article, presenting the Phase I data of the new antihyperalgesic compound, α2-subunit GABA A positive allosteric modulator, N-desmethyl-clobazam (NDMC) is exploring the modulation of a new target in the treatment of neuropathic pain. Based on these results and on its preclinical properties NDMC would qualify as a good tool compound to seek confirmation of the clinical utility of selective GABA allosteric modulators in neuropathic pain patients.",2020,"Compared to placebo, sedation was higher under clonazepam (mean difference= 39 mm [30 to 49] on a visual analog scale, p<0.001) while NDMC was free of sedative effect.","['Secondary hyperalgesia', 'healthy volunteers', 'healthy volunteers, using the UVB-induced experimental pain model', 'Thirty-two subjects participated to the study']","['α2-subunit preferring GABA positive allosteric modulator, N-Desmethyl-Clobazam', 'placebo', 'placebo and active-controlled (clonazepam', 'NDMC60 and placebo', 'Clobazam (NDMC']","['maximal change in the area of cutaneous UVB irradiation-induced secondary hyperalgesia (ASH', 'Steady-state plasma concentrations of NDMC20', 'Mean (SD) relative change', 'level of sedation', 'Mean steady-state concentration', 'ASH', 'absolute change nor relative change in ASH']","[{'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C0994524', 'cui_str': 'Ash, Common'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",32.0,0.216551,"Compared to placebo, sedation was higher under clonazepam (mean difference= 39 mm [30 to 49] on a visual analog scale, p<0.001) while NDMC was free of sedative effect.","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Matthey', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Multidisciplinary Pain Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Daali', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Multidisciplinary Pain Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Curtin', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Multidisciplinary Pain Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Poncet', 'Affiliation': 'Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Desmeules', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Multidisciplinary Pain Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Besson', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Multidisciplinary Pain Center, Geneva University Hospitals, Geneva, Switzerland.'}]","European journal of pain (London, England)",['10.1002/ejp.1554'] 492,32171945,"Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation: An objective, randomized multicenter assessment using spectrophotometry.","PURPOSE Radiation dermatitis represents one of the most frequent side effects in breast cancer patients undergoing adjuvant whole-breast irradiation (WBI). Whether hypofractionated WBI induces comparable or less acute radiation-induced skin reactions than conventional WBI is still not fully clarified, as randomized evidence and objective assessments are limited. The aim of this study was to objectively determine frequency and severity of acute radiation-induced skin reactions during hypofractionated vs. conventionally fractionated adjuvant WBI. METHODS In this randomized multicenter study, a total of 140 breast cancer patients underwent either hypofractionated or conventional WBI following breast-preserving surgery. Maximum radiation dermatitis severity was assessed at completion and during follow-up by physician-assessed CTCAE v4.03 and the patient-reported RISRAS scale. Additionally, photospectrometric skin readings were performed to objectify skin color differences between both treatment arms. RESULTS Radiation dermatitis severity was significantly lower in patients receiving hypofractionation compared with conventional fractionation (mean 1.05 vs. 1.43, p = .024). Grade 0 radiation dermatitis occurred in 21.43% vs. 4.28%, grade ≥2 in 27.14% vs. 42.91% and grade ≥3 in 0% vs. 4.34% of patients following hypofractionated and conventional WBI, respectively. Objective photospectrometric measurements (n = 4200) showed both decreased erythema severity (p = .008) and hyperpigmentation (p = .002) in the hypofractionation arm. Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). CONCLUSION Physician and patient-assessed toxicity scorings as well as objective photospectrometric skin measurements revealed that hypofractionated WBI yielded lower rates and severity of acute radiation-induced skin toxicity.",2020,"Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). ","['140 breast cancer patients underwent either', 'breast cancer patients undergoing adjuvant whole-breast irradiation (WBI']","['spectrophotometry', 'hypofractionated or conventional WBI following breast-preserving surgery', 'hypofractionated vs. conventionally fractionated adjuvant WBI', 'Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation']","['Maximum radiation dermatitis severity', 'photospectrometric skin readings', 'Radiation dermatitis severity', 'radiation dermatitis', 'toxicity scorings', 'hyperpigmentation', 'pain', 'rates and severity of acute radiation-induced skin toxicity', 'Objective photospectrometric measurements', 'erythema severity']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0037805', 'cui_str': 'Spectrophotometry'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",140.0,0.0741957,"Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). ","[{'ForeName': 'Leonard Christopher', 'Initials': 'LC', 'LastName': 'Schmeel', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany. Electronic address: christopher.schmeel@ukbonn.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koch', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Frederic Carsten', 'Initials': 'FC', 'LastName': 'Schmeel', 'Affiliation': 'Department of Radiology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Röhner', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Schoroth', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Bettina Maja', 'Initials': 'BM', 'LastName': 'Bücheler', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Mahlmann', 'Affiliation': 'Radiotherapy Bonn-Rhein-Sieg, Practice at Academic St. Marien Hospital, Bonn, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leitzen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Schüller', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tschirner', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heimann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Dilini', 'Initials': 'D', 'LastName': 'Brüser', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Alina-Valik', 'Initials': 'AV', 'LastName': 'Abramian', 'Affiliation': 'Department of Gynecology and Obstetrics, Division of Senology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Müdder', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Garbe', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Vornholt', 'Affiliation': 'Department of Radiation Oncology, Agaplesion General Hospital, Academic Hospital of the University of Bochum, Hagen, Germany.'}, {'ForeName': 'Hans Heinz', 'Initials': 'HH', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany; Department of Radiology, University Hospital Bonn, University of Bonn, Germany.'}, {'ForeName': 'Brigitta Gertrud', 'Initials': 'BG', 'LastName': 'Baumert', 'Affiliation': 'Institute of Radiation Oncology, Graubuenden Cantonal Hospital, Chur, Switzerland.'}, {'ForeName': 'Timo Martin', 'Initials': 'TM', 'LastName': 'Wilhelm-Buchstab', 'Affiliation': 'Department of Radiation Oncology, University Hospital Bonn, University of Bonn, Germany.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.018'] 493,31423959,"Aromatherapy improves nausea, pain, and mood for patients receiving pediatric palliative care symptom-based consults: A pilot design trial.","OBJECTIVE The role of aromatherapy in supportive symptom management for pediatric patients receiving palliative care has been underexplored. This pilot study aimed to measure the impact of aromatherapy using validated child-reported nausea, pain, and mood scales 5 minutes and 60 minutes after aromatherapy exposure. METHODS The 3 intervention arms included use of a symptom-specific aromatherapy sachet scent involving deep breathing. The parallel default control arm (for those children with medical exclusion criteria to aromatherapy) included use of a visual imagery picture envelope and deep breathing. Symptom burden was sequentially assessed at 5 and 60 minutes using the Baxter Retching Faces scale for nausea, the Wong-Baker FACES scale for pain, and the Children's Anxiety and Pain Scale (CAPS) for anxious mood. Ninety children or adolescents (mean age 9.4 years) at a free-standing children's hospital in the United States were included in each arm (total n = 180). RESULTS At 5 minutes, there was a mean improvement of 3/10 (standard deviation [SD] 2.21) on the nausea scale; 2.6/10 (SD 1.83) on the pain scale; and 1.6/5 (SD 0.93) on the mood scale for the aromatherapy cohort (p < 0.0001). Symptom burden remained improved at 60 minutes post-intervention (<0.0001). Visual imagery with deep breathing improved self-reports of symptoms but was not as consistently sustained at 60 minutes. SIGNIFICANCE OF RESULTS Aromatherapy represents an implementable supportive care intervention for pediatric patients receiving palliative care consults for symptom burden. The high number of children disqualified from the aromatherapy arm because of pulmonary or allergy indications warrants further attention to outcomes for additional breathing-based integrative modalities.",2020,Symptom burden remained improved at 60 minutes post-intervention (<0.0001).,"['pediatric patients receiving palliative care consults for symptom burden', ""Ninety children or adolescents (mean age 9.4 years) at a free-standing children's hospital in the United States were included in each arm (total n = 180"", 'pediatric patients receiving palliative care', 'patients receiving pediatric palliative care symptom-based consults']","['aromatherapy', 'visual imagery picture envelope and deep breathing', 'symptom-specific aromatherapy sachet scent involving deep breathing', 'Aromatherapy']","['pain scale', 'nausea, pain, and mood scales', 'Visual imagery', 'Symptom burden', 'mood scale', ""Baxter Retching Faces scale for nausea, the Wong-Baker FACES scale for pain, and the Children's Anxiety and Pain Scale (CAPS"", 'nausea, pain, and mood', 'nausea scale']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C1328799', 'cui_str': 'Deep breathing (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0222045'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0232602', 'cui_str': 'Retching (finding)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",90.0,0.0509236,Symptom burden remained improved at 60 minutes post-intervention (<0.0001).,"[{'ForeName': 'Meaghann S', 'Initials': 'MS', 'LastName': 'Weaver', 'Affiliation': ""Division of Pediatric Palliative Care, Department of Pediatrics, Children's Hospital and Medical Center, Omaha, NE, USA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': ""Division of Pediatric Palliative Care, Department of Pediatrics, Children's Hospital and Medical Center, Omaha, NE, USA.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wichman', 'Affiliation': 'Division of Biostatistics, Department of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Palliative & supportive care,['10.1017/S1478951519000555'] 494,32182127,Modified Iliotibial Band Tenodesis Is Indicated to Correct Intraoperative Residual Pivot Shift After Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft: A Prospective Randomized Controlled Trial.,"BACKGROUND The indications for the addition of anterolateral soft tissue augmentation to anterior cruciate ligament (ACL) reconstruction and its effectiveness remain uncertain. PURPOSE To determine if modified iliotibial band tenodesis (MITBT) can improve clinical outcomes and reduce the recurrence of ACL ruptures when added to ACL reconstruction in patients with a residual pivot shift. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS Patients with a primary ACL rupture satisfying the following inclusion criteria were enrolled: first ACL rupture, involved in pivoting sports, skeletally mature, no meniscal repair performed, and residual pivot shift relative to the contralateral uninjured knee immediately after ACL reconstruction. Patients were randomized to group A (no further surgery) or group B (MITBT added) and were followed up for 2 years. The patient-reported outcome (PRO) measures used were the International Knee Documentation Committee (IKDC) score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of sport/recreation (Sport/Rec), KOOS subscale of quality of life (QoL), Lysholm knee score (LKS), Tegner activity scale (TAS), recurrent ACL ruptures, or need for further surgery in either knee. Analysis of variance was used to compare PROs; the Wilcoxon test was used for the TAS; and the chi-square test was used for recurrence of ACL ruptures, meniscal injuries, and contralateral ACL ruptures ( P < .05). RESULTS A total of 55 patients were randomized: 27 to group A (female:male ratio = 15:12; mean age, 22.3 ± 3.7 years) and 28 to group B (female:male ratio = 17:11; mean age, 21.8 ± 4.1 years). At 2-year follow-up, group A had a similar IKDC score (90.9 ± 10.7 vs 94.2 ± 11.2; respectively; P = .21), lower KOOS Sport/Rec score (91.5 ± 6.4 vs 95.3 ± 4.4, respectively; P = .02), similar KOOS QoL score (92.0 ± 4.8 vs 95.1 ± 4.3, respectively; P = .14), lower LKS score (92.5 ± 4.8 vs 96.8 ± 8.0, respectively; P = .004), lower TAS score (median, 7 [range, 7-9] vs 8 [range, 8-10], respectively; P = .03), higher rate of recurrence (14.8% vs 0.0%, respectively; P < .001), similar rate of meniscal tears (14.8% vs 3.6%, respectively; P = .14), and similar rate of contralateral ACL ruptures (3.7% vs 3.6%, respectively; P = .99) relative to group B. CONCLUSION The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores. REGISTRATION ACTRN12618001043224 (Australian New Zealand Clinical Trials Registry).",2020,"The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores. ","['55 patients were randomized: 27 to group A (female:male ratio = 15:12; mean age, 22.3 ± 3.7 years) and 28 to group B (female:male ratio = 17:11; mean age, 21.8 ± 4.1 years', 'Patients with a primary ACL rupture satisfying the following inclusion criteria were enrolled: first ACL rupture, involved in pivoting sports, skeletally mature, no meniscal repair performed, and residual pivot shift relative to the contralateral uninjured knee immediately after ACL reconstruction', 'patients with a residual pivot shift']","['modified iliotibial band tenodesis (MITBT', 'anterolateral soft tissue augmentation to anterior cruciate ligament (ACL) reconstruction', 'Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft']","['similar KOOS QoL score', 'rate of contralateral ACL ruptures', 'recurrence of ACL ruptures, meniscal injuries, and contralateral ACL ruptures', 'lower LKS score', 'KOOS Sport/Rec, LKS, and TAS scores', 'lower KOOS Sport/Rec score', 'lower TAS score', 'rate of recurrence', 'International Knee Documentation Committee (IKDC) score, Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of sport/recreation (Sport/Rec), KOOS subscale of quality of life (QoL), Lysholm knee score (LKS), Tegner activity scale (TAS), recurrent ACL ruptures, or need for further surgery in either knee', 'similar IKDC score', 'rate of meniscal tears']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0407887', 'cui_str': 'Repair of meniscus (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1279739', 'cui_str': 'Tendon transplantation (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0034380'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scale'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]",55.0,0.105053,"The augmentation of ACL reconstruction with MITBT reduced the risk of recurrent ACL ruptures in knees with a residual pivot shift after ACL reconstruction and improved KOOS Sport/Rec, LKS, and TAS scores. ","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'Canberra Orthopaedics and Sports Medicine, Bruce, Australian Capital Territory, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Shadbolt', 'Affiliation': 'Canberra Hospital, Garran, Australian Capital Territory, Australia.'}]",The American journal of sports medicine,['10.1177/0363546520910148'] 495,31397288,"Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial.","BACKGROUND Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone. METHODS In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818. FINDINGS From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT. Mean word finding improvements were 1·1% (SD 11·2) in the usual care group, 16·4% (15·3) in the CSLT group, and 2·4% (8·8) in the attention control group. Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group. Mean changes in TOMs were 0·05 (SD 0·59) in the usual care group (n=84), 0·04 (0·58) in the CSLT group (n=81), and 0·10 (0·61) in the attention control group (n=68); the mean difference in change between the CSLT and usual care groups was -0·03 (-0·21 to 0·14; p=0·709) and between the CSLT and attention control groups was -0·01 (-0·20 to 0·18). The incidence of serious adverse events per year were rare with 0·23 events in the usual care group, 0·11 in the CSLT group, and 0·16 in the attention control group. 40 (89%) of 45 serious adverse events were unrelated to trial activity and the remaining five (11%) of 45 serious adverse events were classified as unlikely to be related to trial activity. INTERPRETATION CSLT plus usual care resulted in a clinically significant improvement in personally relevant word finding but did not result in an improvement in conversation. Future studies should explore ways to generalise new vocabulary to conversation for patients with chronic aphasia post-stroke. FUNDING National Institute for Health Research, Tavistock Trust for Aphasia.",2019,Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group.,"['818 patients were assessed for eligibility, of which 278 (34', 'patients with chronic aphasia post-stroke', 'patients were recruited from 21 speech and language therapy departments in the UK', '86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT', 'From Oct 20, 2014, to Aug 18, 2016', 'Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy']","['usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation', 'usual care or attention control (Big CACTUS', 'self-managed computerised speech and language therapy (CSLT', 'CSLT', 'Self-managed, computerised speech and language therapy', 'CSLT and attention control groups']","['Mean changes in TOMs', 'Mean word finding improvements', 'change in ability to retrieve personally relevant words in a picture naming test', 'conversation', 'functional communication ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0379152', 'cui_str': 'lethal toxin LT, Clostridium sordellii'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023009', 'cui_str': 'Speech and language disorder (disorder)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607943', 'cui_str': 'findings'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0379152', 'cui_str': 'lethal toxin LT, Clostridium sordellii'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0330340', 'cui_str': 'Cactus'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0565998', 'cui_str': 'Communication ability'}]",818.0,0.115065,Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palmer', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Dimairo', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK. Electronic address: c.l.cooper@sheffield.ac.uk.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Enderby', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, The University of Manchester MAHSC, Manchester, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Latimer', 'Affiliation': 'Department of Health Economics and Decision Science, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Julious', 'Affiliation': 'Department of Design, Trials and Statistics, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cross', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'Department of Health Economics and Decision Science, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Witts', 'Affiliation': 'Deparment of Health Service Research, School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK; Speech and Language Therapy, Derbyshire Community Health Services NHS Foundation Trust, Chesterfield, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'Clinical Trials Research Unit (CTRU), ScHARR, The University of Sheffield, Sheffield, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30192-9'] 496,31566579,DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial.,"BACKGROUNDRV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTSAll regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final vaccination at high magnitude. While IgG3 responses were highest in T3, a lower IgA/IgG ratio was observed in T4. Binding antibodies persisted at 12 months in 35%-100% of participants. Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively. CD4+ T cell responses were detectable in all treatment groups (32%-64%) without appreciable CD8+ T cell responses.CONCLUSIONThe DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2-binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses.TRIAL REGISTRATIONClinicalTrials.gov NCT02207920.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID) grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069511, UM1 AI069470, UM1 AI069534, P30 AI450008, UM1 AI069439, UM1 AI069481, and UM1 AI069496; the National Center for Advancing Translational Sciences, NIH (grant UL1TR001873); and the Bill & Melinda Gates Foundation (grant OPP52845).",2019,"Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively.","['ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants', 'humans']","['protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit', 'DNA-HIV-PT123 (DNA) vaccine']","['tolerated', 'Binding antibodies', 'HIV-specific antibodies', 'lower IgA/IgG ratio', 'CD4+ T cell responses', 'IgG3 responses']","[{'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}]",,0.119543,"Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively.","[{'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Shuying S', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Sanchez', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Swann', 'Affiliation': 'Division of AIDS, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Magdalena E', 'Initials': 'ME', 'LastName': 'Sobieszczyk', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Wilson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Hong-Van', 'Initials': 'HV', 'LastName': 'Tieu', 'Affiliation': 'New York Blood Center, New York, New York, USA.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Maenza', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Norwood', 'Affiliation': 'UCSF, San Francisco, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kobie', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, California, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Keefer', 'Affiliation': 'Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of clinical investigation,['10.1172/JCI128699'] 497,31595861,A feasibility and acceptability study of an adaptation of the Mindful Self-Compassion program for adult cancer patients.,"OBJECTIVES Psychosocial interventions that mitigate psychosocial distress in cancer patients are important. The primary aim of this study was to examine the feasibility and acceptability of an adaptation of the Mindful Self-Compassion (MSC) program among adult cancer patients. A secondary aim was to examine pre-post-program changes in psychosocial wellbeing. METHOD The research design was a feasibility and acceptability study, with an examination of pre- to post-intervention changes in psychosocial measures. A study information pack was posted to 173 adult cancer patients 6 months-5 years post-diagnosis, with an invitation to attend an eight-week group-based adaptation of the MSC program. RESULTS Thirty-two (19%) consented to the program, with 30 commencing. Twenty-seven completed the program (mean age: 62.93 years, SD 14.04; 17 [63%] female), attending a mean 6.93 (SD 1.11) group sessions. There were no significant differences in medico-demographic factors between program-completers and those who did not consent. However, there was a trend toward shorter time since diagnosis in the program-completers group. Program-completers rated the program highly regarding content, relevance to the concerns of cancer patients, and the likelihood of recommending the program to other cancer patients. Sixty-three percent perceived that their mental wellbeing had improved from pre- to post-program; none perceived a deterioration in mental wellbeing. Small-to-medium effects were observed for depressive symptoms, fear of cancer recurrence, stress, loneliness, body image satisfaction, mindfulness, and self-compassion. SIGNIFICANCE OF RESULTS The MSC program appears feasible and acceptable to adults diagnosed with non-advanced cancer. The preliminary estimates of effect sizes in this sample suggest that participation in the program was associated with improvements in psychosocial wellbeing. Collectively, these findings suggest that there may be value in conducting an adequately powered randomized controlled trial to determine the efficacy of the MSC program in enhancing the psychosocial wellbeing of cancer patients.",2020,"Small-to-medium effects were observed for depressive symptoms, fear of cancer recurrence, stress, loneliness, body image satisfaction, mindfulness, and self-compassion. ","['Twenty-seven completed the program (mean age: 62.93 years, SD 14.04; 17 [63%] female), attending a mean 6.93 (SD 1.11) group sessions', 'adult cancer patients', 'Thirty-two (19%) consented to the program, with 30 commencing', 'adults diagnosed with non-advanced cancer', 'cancer patients', '173 adult cancer patients 6 months-5 years post-diagnosis, with an invitation to attend an eight-week group-based adaptation of the MSC program']","['Mindful Self-Compassion (MSC) program', 'Mindful Self-Compassion program', 'MSC program']","['shorter time since diagnosis', 'deterioration in mental wellbeing', 'psychosocial wellbeing', 'depressive symptoms, fear of cancer recurrence, stress, loneliness, body image satisfaction, mindfulness, and self-compassion', 'mental wellbeing', 'feasibility and acceptability', 'medico-demographic factors']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}]",173.0,0.0218409,"Small-to-medium effects were observed for depressive symptoms, fear of cancer recurrence, stress, loneliness, body image satisfaction, mindfulness, and self-compassion. ","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Brooker', 'Affiliation': 'Szalmuk Family Psycho-Oncology Research Unit, Cabrini Health, 154 Wattletree Road, Malvern3144, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Julian', 'Affiliation': 'Thinking Healthy, Melbourne, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': 'Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne3004, Australia.'}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne3800, Australia.'}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Kenealy', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne3800, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Herbert', 'Affiliation': 'Cabrini Health, 181 Wattletree Road, Malvern3144, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Graham', 'Affiliation': 'Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne3800, Australia.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne3004, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kissane', 'Affiliation': 'Szalmuk Family Psycho-Oncology Research Unit, Cabrini Health, 154 Wattletree Road, Malvern3144, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne3004, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne3800, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Porter', 'Affiliation': 'Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne3004, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fletcher', 'Affiliation': 'Cabrini Health, 181 Wattletree Road, Malvern3144, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Haines', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne3800, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Burney', 'Affiliation': 'Szalmuk Family Psycho-Oncology Research Unit, Cabrini Health, 154 Wattletree Road, Malvern3144, Australia.'}]",Palliative & supportive care,['10.1017/S1478951519000737'] 498,32150478,Efficacy and safety of three different endoscopic methods in treatment of 6-20 mm colorectal polyps.,"Objective: Endoscopic resection of colorectal polyps is widely established as the optimal method to manage precancerous lesions. But the optimal technique for removal of the polyps is uncertain. The aim of this study was to compare the efficacy and safety of three methods for the management of 6-20mm colorectal polyps. Methods: A prospective, randomised controlled trial was conducted at the 900TH Hospital of Joint Logistics Support Force in Fujian, China. Endoscopically diagnosed colorectal polyps, 6-20 mm in size, were randomly assigned to the cold snare polypectomy (CSP), cold snare endoscopic mucosal resection (CS-EMR) or endoscopic mucosal resection (EMR) group. After polypectomy, additional 3-5 forceps biopsies by leading narrow-band imaging (NBI) were performed at the base and margins of polypectomy sites to assess the presence of residual polyp tissue and all samples were sent for histopathological analysis to assess completeness of resection. Polypectomy timing, tissue retrieval and complications were recorded at the time of the procedure. Results: A total of 781 polyps in 404 patients were assessed and randomly assigned to each group. Of these, 763 polyps were finally analyzed based on the pathology results. The complete resection rates with CSP, CS-EMR and EMR were 81.6%, 94.1% and 95.5%, respectively ( p  < .001). The intraprocedural bleeding rate, immediately after polypectomy, was significantly higher in the CSP group than in the CS-EMR and EMR group (9.4% vs. 4.4% vs. 1.9%; p  < .001). However,delayed bleeding was higher in the EMR group than in the CSP and CS-EMR group (2.6% vs. 1.2% vs. 0.8%, respectively; p  = .215). In the multivariate analysis showed that the operation method, lesion size , morphology and the number of resection were independent risk factors for complete resection rate (CRR) ( p < .05), but the location and pathological classification of polyps had no significant influence on CRR. Conclusions: CS-EMR is safe and effective in the treatment of 6-20 mm colorectal polyps. Especially for 6-15 mm non-pedunculated polyps, CS-EMR has a high histological complete resection rate comparable to EMR, and retains the low risk of delayed complications after polypectomy with cold snare. CS-EMR is expected to become a more valuable new cold-cutting technique after cold snare polypectomy.",2020,"Especially for 6-15 mm non-pedunculated polyps, CS-EMR has a high histological complete resection rate comparable to EMR, and retains the low risk of delayed complications after polypectomy with cold snare.","['A total of 781 polyps in 404 patients', '6-20mm colorectal polyps', 'Endoscopically diagnosed colorectal polyps, 6-20 mm in size', '900TH Hospital of Joint Logistics Support Force in Fujian, China', '6-20\u2009mm colorectal polyps']","['EMR', 'Endoscopic resection', 'CSP', 'CS-EMR', 'cold snare polypectomy (CSP), cold snare endoscopic mucosal resection (CS-EMR) or endoscopic mucosal resection (EMR) group']","['intraprocedural bleeding rate', 'Efficacy and safety', 'CRR', 'efficacy and safety', 'delayed bleeding', 'complete resection rate (CRR', 'complete resection rates with CSP, CS-EMR and EMR', 'Polypectomy timing, tissue retrieval and complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1700928', 'cui_str': 'Endoscopic Mucous Membrane Resection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",404.0,0.0639041,"Especially for 6-15 mm non-pedunculated polyps, CS-EMR has a high histological complete resection rate comparable to EMR, and retains the low risk of delayed complications after polypectomy with cold snare.","[{'ForeName': 'Dazhou', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Chuanshen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}, {'ForeName': 'Donggui', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': 'Department of Gastroenterology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1732456'] 499,32207767,Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial.,"Importance Dietary supplements marketed for male fertility commonly contain folic acid and zinc based on limited prior evidence for improving semen quality. However, no large-scale trial has examined the efficacy of this therapy for improving semen quality or live birth. Objective To determine the effect of daily folic acid and zinc supplementation on semen quality and live birth. Design, Setting, and Participants The Folic Acid and Zinc Supplementation Trial was a multicenter randomized clinical trial. Couples (n = 2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017. The last 6-month study visit for semen collection occurred during August 2018, with chart abstraction of live birth and pregnancy information completed during April 2019. Interventions Men were block randomized by study center and planned infertility treatment (in vitro fertilization, other treatment at a study site, and other treatment at an outside clinic) to receive either 5 mg of folic acid and 30 mg of elemental zinc (n = 1185) or placebo (n = 1185) daily for 6 months. Main Outcomes and Measures The co-primary outcomes were live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count) at 6 months after randomization. Results Among 2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit. Live birth outcomes were available for all couples, and 1629 men (69%) had semen available for analysis at 6 months after randomization. Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]). Most of the semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count) were not significantly different between treatment groups at 6 months after randomization. A statistically significant increase in DNA fragmentation was observed with folic acid and zinc supplementation (mean of 29.7% for percentage of DNA fragmentation in the folic acid and zinc group and 27.2% in the placebo group; mean difference, 2.4% [95% CI, 0.5% to 4.4%]). Gastrointestinal symptoms were more common with folic acid and zinc supplementation compared with placebo (abdominal discomfort or pain: 66 [6%] vs 40 [3%], respectively; nausea: 50 [4%] vs 24 [2%]; and vomiting: 32 [3%] vs 17 [1%]). Conclusions and Relevance Among a general population of couples seeking infertility treatment, the use of folic acid and zinc supplementation by male partners, compared with placebo, did not significantly improve semen quality or couples' live birth rates. These findings do not support the use of folic acid and zinc supplementation by male partners in the treatment of infertility. Trial Registration ClinicalTrials.gov Identifier: NCT01857310.",2020,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","['2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017', 'Couples Undergoing Infertility Treatment', 'Couples (n\u2009', '2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit']","['daily folic acid and zinc supplementation', 'folic acid and zinc', 'Folic Acid and Zinc Supplementation', 'folic acid and zinc supplementation', 'placebo', 'planned infertility treatment (in vitro fertilization', 'folic acid and 30 mg of elemental zinc (n\u2009=\u20091185) or placebo']","[""semen quality or couples' live birth rates"", 'semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count', 'Gastrointestinal symptoms', 'live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count', 'DNA fragmentation', 'Semen Quality and Live Birth', 'Live birth outcomes', 'Live birth', 'semen quality and live birth', 'semen quality or live birth', 'vomiting', 'nausea']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",2370.0,0.613709,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","[{'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Departments of Surgery (Urology) and Human Genetics, School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Van Voorhis', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hotaling', 'Affiliation': ""Center for Reconstructive Urology and Men's Health, Departments of Surgery (Urology) and Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",JAMA,['10.1001/jama.2019.18714'] 500,32125875,Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction of Acute Anterior Cruciate Ligament Tears: 2-Year Results From a Prospective Randomized Study.,"BACKGROUND Anterior cruciate ligament (ACL) repair has once again become a focus of research because of the development of new techniques. PURPOSE/HYPOTHESIS The purpose was to compare the functional results and recurrent instability rates in patients undergoing ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR) for acute isolated ACL tears. The hypothesis was that functional results and knee joint stability after ACL repair with DIS would be comparable with that after ACLR. STUDY DESIGN Randomized clinical trial; Level of evidence, 1. METHODS A total of 85 patients with acute ACL tears were randomized to undergo either ACL repair with DIS or primary ACLR. The preinjury activity level and function were recorded. Follow-up examinations were performed at 6 weeks and 6, 12, and 24 months postoperatively. Anterior tibial translation (ATT) was evaluated using Rolimeter testing. The Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores were obtained. Clinical failure was defined as ΔATT >3 mm in combination with subjective instability. Recurrent instability and other complications were recorded. RESULTS There were 83 patients (97.6%) who were successfully followed until 2 years. ATT was significantly increased in the DIS group compared with the ACLR group (ΔATT, 1.9 vs 0.9 mm, respectively; P = .0086). A total of 7 patients (16.3%) in the DIS group had clinical failure and underwent single-stage revision. In the ACLR group, 5 patients (12.5%) had failure of the reconstruction procedure; 4 of these patients required 2-stage revision. The difference in the failure rate was not significant ( P = .432). There were 4 patients (3 in the DIS group and 1 in the ACLR group) who showed increased laxity (ΔATT >3 mm) without subjective instability and did not require revision. Recurrent instability was associated with young age (<25 years) and high Tegner scores (>6) in both groups. No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time. CONCLUSION Whereas ATT measured by Rolimeter testing was significantly increased after ACL repair with DIS, clinical failure was similar to that after ACLR. In addition, functional results after ACL repair with DIS for acute tears were comparable with those after ACLR. The current study supports the use of ACL repair with DIS as an option to treat acute ACL tears. REGISTRATION DRKS00015466 (German Clinical Trials Register).",2020,"No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time. ","['83 patients (97.6%) who were successfully followed until 2 years', '85 patients with acute ACL tears', 'patients undergoing', 'Acute Anterior Cruciate Ligament Tears']","['ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR', 'Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction', 'Anterior cruciate ligament (ACL) repair', 'ACLR', 'ACL repair with DIS or primary ACLR', 'ACL repair with DIS']","['ACL repair with DIS and ACLR', 'Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores', 'Recurrent instability and other complications', 'Recurrent instability', 'preinjury activity level and function', 'Anterior tibial translation (ATT', 'failure rate', 'clinical failure', 'Tegner, IKDC, and Lysholm scores', 'knee joint stability', 'Clinical failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4305267', 'cui_str': 'Lysholm Knee Scoring Scale score'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0427261', 'cui_str': 'Knee joint stability (observable entity)'}]",85.0,0.0577479,"No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time. ","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Kösters', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Glasbrenner', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Spickermann', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kittl', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Domnick', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Herbort', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schliemann', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520905863'] 501,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo. SUBJECTS/METHODS Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively. RESULTS Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior. CONCLUSIONS This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z'] 502,31535613,"Fatigue in patients on oral targeted or chemotherapy for cancer and associations with anxiety, depression, and quality of life.","OBJECTIVES Oral treatment (targeted or chemotherapy) for cancer is being increasingly used. While fatigue is a known side effect of intravenous chemotherapy, the rate of fatigue and the impact of fatigue on other patient-reported outcomes are not well described. METHOD At Massachusetts General Hospital Cancer Center, 180 adult patients prescribed oral targeted or chemotherapy for various malignancies enrolled in a randomized controlled trial of adherence and symptom management. Patients completed baseline self-reported measures of fatigue (Brief Fatigue Inventory; BFI), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale; HADS), and quality of life, including subscales for physical, social, emotional, and functional well-being ([QOL] Functional Assessment of Cancer Therapy - General; FACT-G). We examined clinically relevant fatigue using a validated cut-off score for moderate-severe fatigue (BFI global fatigue ≥4) and tested the associations with anxiety symptoms, depressive symptoms, and QOL with independent samples t-tests. RESULTS At baseline, 45 of 180 participants (25.0%) reported moderate-severe fatigue. Fatigued patients experienced more anxiety symptoms (mean diff. 3.73, P < 0.001), more depressive symptoms (mean diff. 4.14, P < 0.001), and worse QOL on the total FACT-G score (mean diff. -19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue. SIGNIFICANCE OF RESULTS One in four patients on oral treatment for cancer experienced clinically relevant fatigue that is associated with greater anxiety and depressive symptoms and worse QOL.",2020,"-19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue. ",['180 adult patients prescribed'],['oral targeted or chemotherapy'],"['total FACT-G score', 'anxiety symptoms', 'depressive symptoms', 'fatigue (Brief Fatigue Inventory; BFI), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale; HADS), and quality of life, including subscales for physical, social, emotional, and functional well-being ([QOL] Functional Assessment of Cancer Therapy - General; FACT-G', 'anxiety, depression, and quality of life', 'moderate-severe fatigue', 'anxiety and depressive symptoms and worse QOL']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",180.0,0.10128,"-19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue. ","[{'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Poort', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}]",Palliative & supportive care,['10.1017/S147895151900066X'] 503,32146259,Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy.,"BACKGROUND AND PURPOSE High dose-rate (HDR) brachytherapy as monotherapy is a treatment option for localized prostate cancer, but optimal dose and fractionation is unknown. We report efficacy results of a randomized phase II trial of HDR monotherapy delivered as either one or two fractions. MATERIALS AND METHODS Eligible patients had low or intermediate risk prostate cancer, prostate volume <60 cc, and no androgen deprivation use. 170 patients were randomized to receive HDR as either a single fraction of 19 Gy or as two fractions of 13.5 Gy one week apart. Median age was 65 years, median PSA was 6.33 ng/ml, and Grade Group 1, 2 and 3 was present in 28%, 60%, and 12%, respectively. There was no difference in baseline factors between arms and 19%, 51% and 30% had low risk, favourable intermediate and unfavourable intermediate risk disease, respectively. The Phoenix definition was used to define biochemical failure, all local failures were confirmed by biopsy and toxicity was assessed using CTCAE v.4. RESULTS Median follow-up was 60 months. PSA decreased more quickly in the 2-fraction arm (p = 0.009). Median PSA at 5-years was 0.65 ng/ml in the single fraction and 0.16 ng/ml in the 2-fraction arm. The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively. Recurrence was not associated with initial stage, grade group, or risk group. Grade 2 late rectal toxicity occurred in 1% while the incidence of grade 2 and 3 urinary toxicity was 45% and 1%, respectively, with no difference between arms. CONCLUSIONS HDR monotherapy delivered as two fraction of 13.5 Gy is well tolerated with a high cancer control rate at 5 years. Single fraction monotherapy is inferior and should not be used.",2020,"The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively.","['170 patients', 'low and intermediate risk prostate cancer', 'Eligible patients had low or intermediate risk prostate cancer, prostate volume']","['HDR', 'HDR monotherapy', 'rate (HDR) brachytherapy', 'Prostate high dose-rate brachytherapy as monotherapy']","['PSA', 'Recurrence', 'urinary toxicity', '5-year biochemical disease-free survival and cumulative incidence of local failure', 'baseline factors', 'Grade 2 late rectal toxicity', 'median PSA', 'Median PSA']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy (observable entity)'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",170.0,0.117532,"The 5-year biochemical disease-free survival and cumulative incidence of local failure was 73.5% and 29% in the single fraction arm and 95% (p = 0.001) and 3% (p < 0.001) in the 2-fraction arm, respectively.","[{'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Morton', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada. Electronic address: gerard.morton@sunnybrook.ca.'}, {'ForeName': 'Merrylee', 'Initials': 'M', 'LastName': 'McGuffin', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Hans T', 'Initials': 'HT', 'LastName': 'Chung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Chia-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Helou', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Szumacher', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Sunnybrook Odette Cancer Centre, University of Toronto, Canada.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.009'] 504,32238920,Ki-67 response-guided preoperative chemotherapy for HER2-positive breast cancer: results of a randomised Phase 2 study.,"BACKGROUND The effectiveness of a therapeutic strategy that switches chemotherapy, based on Ki-67 tumour expression after initial therapy, relative to that of standard chemotherapy, has not been evaluated. METHODS Patients were randomly assigned to the control arm or the Ki-67 response-guided arm (Ki-67 arm). Primary tumour biopsies were obtained before treatment, and after three once-weekly doses of paclitaxel and trastuzumab to assess the interim Ki-67 index. In the control arm, paclitaxel and trastuzumab were continued for a total of 12 doses, regardless of the interim Ki-67 index. In the Ki-67 arm, subsequent treatment was based on the interim Ki-67 index. Ki-67 early responder is defined as the absolute Ki-67 value that was <10%, and the percentage of Ki-67-positive tumour cells was reduced by >30% compared with before treatment. Early Ki-67 responders continued to receive the same treatment, while early Ki-67 non-responders were switched to epirubicin plus cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate. RESULTS A total of 237 patients were randomised. There was almost linear correlation between the Ki-67 reduction rate at interim assessment and the pCR rate. The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). CONCLUSIONS The standard chemotherapy protocol remains as the recommended strategy for patients with HER2-positive breast cancer. CLINICAL TRIAL REGISTRATION Clinical Trial Registration: UMIN-CTR as UMIN000007074.",2020,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","['patients with HER2-positive breast cancer', '237 patients were randomised', 'HER2-positive breast cancer', 'Patients']","['paclitaxel and trastuzumab', 'Ki-67 response-guided preoperative chemotherapy', 'epirubicin plus cyclophosphamide', 'Ki-67 response-guided arm (Ki-67 arm']","['pathological complete response (pCR) rate', 'absolute Ki-67 value', 'pCR rate', 'Ki-67 reduction rate', 'percentage of Ki-67-positive tumour cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}]",237.0,0.0497755,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan. hrmukai@east.ncc.go.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Musashino Red Cross Hospital, Musashino, Tokyo, 180-0023, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Ibaraki, 305-8576, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Gunma, 373-0828, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0245, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Akabane', 'Affiliation': 'Asahikawa-Kosei General Hospital, Hokkaido, Asahikawa, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Chuo Ward, Kumamoto, 862-8655, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Osaka City University Graduate School of Medicine, Sumiyoshi Ward, Osaka, 558-0022, Japan.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, 981-8558, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Hakuaikai Medical Corp Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Aichi, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Imoto', 'Affiliation': 'Kyorin University Hospital, Mitaka, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Mie University Hospital, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'National Cancer Center Research Institute, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}]",British journal of cancer,['10.1038/s41416-020-0815-9'] 505,32231105,Daily School Physical Activity from Before to After Puberty Improves Bone Mass and a Musculoskeletal Composite Risk Score for Fracture.,"This 7.5-year prospective controlled exercise intervention study assessed if daily school physical activity (PA), from before to after puberty, improved musculoskeletal traits. There were 63 boys and 34 girls in the intervention group (40 min PA/day), and 26 boys and 17 girls in the control group (60 min PA/week). We measured musculoskeletal traits at the start and end of the study. The overall musculoskeletal effect of PA was also estimated by a composite score (mean Z-score of the lumbar spine bone mineral content (BMC), bone area (BA), total body lean mass (TBLM), calcaneal ultrasound (speed of sound (SOS)), and muscle strength (knee flexion peak torque)). We used analyses of covariance (ANCOVA) for group comparisons. Compared to the gender-matched control group, intervention boys reached higher gains in BMC, BA, muscle strength, as well as in the composite score, and intervention girls higher gains in BMC, BA, SOS, as well as in the composite score (all p < 0.05, respectively). Our small sample study indicates that a daily school-based PA intervention program from Tanner stage 1 to 5 in both sexes is associated with greater bone mineral accrual, greater gain in bone size, and a greater gain in a musculoskeletal composite score for fractures.",2020,"Compared to the gender-matched control group, intervention boys reached higher gains in BMC, BA, muscle strength, as well as in the composite score, and intervention girls higher gains in BMC, BA, SOS, as well as in the composite score (all p < 0.05, respectively).","['63 boys and 34 girls in the intervention group (40 min PA/day), and 26 boys and 17 girls in the control group (60 min PA/week']",['daily school-based PA intervention program'],"['Bone Mass and a Musculoskeletal Composite Risk Score for Fracture', 'bone mineral accrual, greater gain in bone size', 'Daily School Physical Activity', 'BMC, BA, SOS, as well as in the composite score', 'overall musculoskeletal effect of PA', 'BMC, BA, muscle strength, as well as in the composite score', 'musculoskeletal traits', 'lumbar spine bone mineral content (BMC), bone area (BA), total body lean mass (TBLM), calcaneal ultrasound (speed of sound (SOS)), and muscle strength (knee flexion peak torque', 'daily school physical activity (PA']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}]",63.0,0.0283617,"Compared to the gender-matched control group, intervention boys reached higher gains in BMC, BA, muscle strength, as well as in the composite score, and intervention girls higher gains in BMC, BA, SOS, as well as in the composite score (all p < 0.05, respectively).","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Cronholm', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lindgren', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Rosengren', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Dencker', 'Affiliation': 'Department of Physiology and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Karlsson', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}, {'ForeName': 'Magnus K', 'Initials': 'MK', 'LastName': 'Karlsson', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Skane University Hospital, Lund University, SE-205 02 Malmo, Sweden.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040040'] 506,32128995,"Effects of a carbohydrate-restricted diet on hepatic lipid content in adolescents with non-alcoholic fatty liver disease: A pilot, randomized trial.","BACKGROUND Non-alcoholic fatty liver disease (NAFLD) has emerged as the most common form of liver disease among adolescents in industrialized countries. While lifestyle intervention remains the hallmark treatment for NAFLD, the most effective dietary strategy to reverse NAFLD in children is unknown. OBJECTIVE The objective of this study was to determine the effects of a moderately CHO-restricted diet (CRD) vs fat-restricted diet (FRD) in adolescents with NAFLD on reduction in liver fat and insulin resistance. METHODS Thirty-two children/adolescents (age 9-17) with obesity and NAFLD were randomized to a CRD (<25:25:>50% energy from CHO:protein:fat) or FRD (55:25:20) for 8 weeks. Caloric intakes were calculated to be weight maintaining. Change in hepatic lipid content was measured via magnetic resonance imaging, body composition via dual energy X ray absorptiometry and insulin resistance via a fasting blood sample. RESULTS Change in hepatic lipid did not differ with diet, but declined significantly (-6.0 ± 4.7%, P < .001 only within the CRD group. We found significantly greater decreases in insulin resistance (HOMA-IR, <.05), abdominal fat mass (P < .01) and body fat mass (P < .01) in response to the CRD vs FRD. CONCLUSION These findings suggest that consumption of a moderately CHO-restricted diet may result in decreased hepatic lipid as well as improvements in body composition and insulin resistance in adolescents with NAFLD even in the absence of intentional caloric restriction. Larger studies are needed to determine whether a CHO-restricted diet induces change in hepatic lipid independent of change in body fat.",2020,"We found significantly greater decreases in insulin resistance (HOMA-IR, <.05), abdominal fat mass (P < .01) and body fat mass (P < .01) in response to the CRD vs FRD. ","['adolescents with NAFLD', 'Thirty-two children/adolescents (age 9-17) with obesity and NAFLD', 'adolescents with NAFLD on reduction in liver fat and insulin resistance', 'adolescents with non-alcoholic fatty liver disease']","['CRD (<25:25:>50% energy from CHO:protein:fat) or FRD', 'carbohydrate-restricted diet', 'moderately CHO-restricted diet (CRD) vs fat-restricted diet (FRD']","['insulin resistance (HOMA-IR, <.05), abdominal fat mass', 'body composition and insulin resistance', 'hepatic lipid content', 'hepatic lipid', 'Caloric intakes', 'body fat mass']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",32.0,0.0735436,"We found significantly greater decreases in insulin resistance (HOMA-IR, <.05), abdominal fat mass (P < .01) and body fat mass (P < .01) in response to the CRD vs FRD. ","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Goss', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Dowla', 'Affiliation': 'School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Pendergrass', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ambika', 'Initials': 'A', 'LastName': 'Ashraf', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bolding', 'Affiliation': 'Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Alesha', 'Initials': 'A', 'LastName': 'Amerson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Soleymani', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gower', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Pediatric obesity,['10.1111/ijpo.12630'] 507,31455897,"Body weight, body composition and survival after 1 year: follow-up of a nutritional intervention trial in allo-HSCT recipients.","The role of body weight change in survival among recipients of hematopoietic stem-cell transplantation is controversial. We assessed the effect of optimizing energy and protein intake on 1-year survival, body weight and body composition, and the effect of body weight and body composition on 1-year survival in 117 patients (57 intervention, 60 control) in a randomized controlled trial. Cox regression was used to study effects of the intervention, weight and body composition on death, relapse, and nonrelapse mortality (NRM). We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90). Body weight, fat-free mass index, body fat mass index and total body water changed over time (p < 0.001), similarly in both groups (0.17 ≤ p ≤ 0.98). In multivariable analyses adjusted for group, gender and age, HRs and 95% CIs per one kilo increase in weight were 1.03 (1.01-1.06) and 1.04 (1.01-1.08) for death and NRM after 1 year (p ≤ 0.02), respectively, and 1.08 (1.01-1.15) for relapse after 3 months (p = 0.02). In conclusion, weight gain is possibly due to fluid retention and is an indicator of a complication in HSCT, rather than a marker of improved nutritional status.",2019,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","['allo-HSCT recipients', '117 patients (57 intervention, 60 control', 'recipients of hematopoietic stem-cell transplantation']",['optimizing energy and protein intake'],"['Body weight, body composition and survival', 'relapse', 'weight and body composition on death, relapse, and nonrelapse mortality (NRM', 'weight', 'Body weight, fat-free mass index, body fat mass index and total body water changed over time', 'weight gain', 'death and NRM', 'death hazard ratio', '1-year survival, body weight and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",117.0,0.156154,"We found no significant effect of intervention versus control on death hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.54-2.04, p = 0.88), relapse (HR 1.15, 95% CI 0.48-2.27, p = 0.75), and NRM (HR 0.95, 95% CI 0.39-2.28, p = 0.90).","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Skaarud', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway. kskaarud@ous-hf.no.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Veierød', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lergenmuller', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Haematology, Oslo University Hospital, Oslo, Norway.'}]",Bone marrow transplantation,['10.1038/s41409-019-0638-6'] 508,32228789,"Effects of Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions on Child Respiratory Infections in Rural Kenya: A Cluster-Randomized Controlled Trial.","Poor nutrition and hand hygiene are risk factors for acute respiratory infections (ARIs). Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs. Within a trial assessing impacts of water, sanitation, and handwashing (WASH), and nutritional interventions, we evaluated effects on ARIs. The WASH Benefits cluster-randomized trial enrolled pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery. Geographically adjacent clusters were block-randomized into a passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN. The main outcome was the prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing) in children younger than 3 years. Masking participants was not possible. Analyses were intention-to-treat. Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data. The cluster-level intra-cluster correlation coefficient for ARIs was 0.026 across both years. Water, sanitation, and handwashing interventions with behavior change messaging did not reduce ARIs. Nutrition counseling and LNS modestly reduced ARI symptoms compared with controls in year 1 [prevalence ratio (PR): 0.87, 95% confidence interval (CI): 0.77-0.99], but no effect in the combined WSHN group weakens this finding.",2020,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","['pregnant women from Kenyan villages and evaluated health outcomes in children born to enrolled mothers 1 and 2 years after intervention delivery', 'children younger than 3 years', 'Child Respiratory Infections in Rural Kenya', 'Between November 2012 and May 2014, 702 clusters were enrolled, including 6,960 (year 1) and 7,088 (year 2) children with ARI data']","['passive control (no promotional visits), a double-sized active control (monthly visits to measure mid-upper arm circumference), and six intervention groups: chlorinated drinking water (W), improved sanitation (S), handwashing with soap (H), combined WSH, improved nutrition (N) through counseling and lipid-based nutrient supplementation (LNS), and combined WSHN', 'water, sanitation, and handwashing (WASH), and nutritional interventions', 'Individual and Combined Water, Sanitation, Handwashing, and Nutritional Interventions', 'Nutrition counseling and LNS']","['prevalence of ARI symptoms (cough, panting, wheezing, or difficulty breathing', 'ARI symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0453927', 'cui_str': 'Pants'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.102307,"Safe drinking water and sanitation can reduce exposure to pathogens and encourage healthy immune responses, reducing the risk of ARIs.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Swarthout', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Epidemiology and Environmental Health, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Dentz', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kalungu', 'Affiliation': 'Innovations for Poverty Action, Nairobi, Kenya.'}, {'ForeName': 'Audrie', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Sammy M', 'Initials': 'SM', 'LastName': 'Njenga', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Null', 'Affiliation': 'Center for International Policy Research and Evaluation, Mathematica Policy Research, Washington, District of Columbia.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Civil and Environmental Engineering, Tufts University, Medford, Massachusetts.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0779'] 509,32232781,Longitudinal resident coaching in the outpatient setting: A novel intervention to improve ambulatory consultation skills.,"BACKGROUND Direct observation with feedback to learners should be a mainstay in resident education, yet it is infrequently done and its impact on consultation skills has rarely been assessed. APPROACH This project presents the framework and implementation of a longitudinal low-frequency, high-intensity direct observation and coaching intervention, and elaborates on insights learned. Internal medicine interns at one residency training program were randomized to an ambulatory coaching intervention or usual precepting. Over one year, coached interns had three complete primary care visits directly observed by a faculty clinician-coach who provided feedback informed by a behavior checklist. Immediately after each of the coached patient encounters, interns completed a structured self-assessment and coaches led a 30-minute feedback session informed by intern self-reflection and checklist items. Interns with usual precepting had two mini-CEX observations over the course of the year without other formal direct observation in the ambulatory setting. EVALUATION As part of the post-intervention assessment, senior faculty members blinded to intervention and control group assignments evaluated videotaped encounters. Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05). The median overall grade for coached interns was B+, compared to B-/C+ for controls (p < 0.05). REFLECTION Coaching interns longitudinally using a behavior checklist is feasible and associated with improved consultation performance. Direct observation of complete clinical encounters followed by systematic coaching is educationally valuable, but time and resource intensive.",2020,"Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05).",['Internal medicine interns at one residency training program'],['ambulatory coaching intervention or usual precepting'],['median overall grade'],"[{'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0156887,"Coached interns completed an average of 21/23 behaviors from the checklist, while interns from the control group completed 18 (p < 0.05).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Graddy', 'Affiliation': 'Division of Addiction Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. ryan.graddy@gmail.com.'}, {'ForeName': 'Stasia S', 'Initials': 'SS', 'LastName': 'Reynolds', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wright', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins Bayview Medical Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",Perspectives on medical education,['10.1007/s40037-020-00573-5'] 510,32229495,"Evaluation of the Effect of Contezolid (MRX-I) on the Corrected QT Interval in a Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study in Healthy Chinese Volunteers.","Contezolid (MRX-I), a new oxazolidinone, is an antibiotic in development for treating complicated skin and soft tissue infections caused by resistant Gram-positive bacteria. This was a thorough QT study conducted in 52 healthy subjects who were administered oral contezolid at a therapeutic (800 mg) dose, a supratherapeutic (1,600 mg) dose, placebo, and oral moxifloxacin at 400 mg in four separate treatment periods. The pharmacokinetic profile of contezolid was also evaluated. Time point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point. The upper bound of the 90% CI for ΔΔQTc was slightly more than 10 ms with the contezolid supratherapeutic dose at 3 and 4 h postdose, and the prolongation effect on the QT/QTc interval was less than that of the positive control, moxifloxacin, at 400 mg. At 3 and 4 h after the moxifloxacin dose, the moxifloxacin group met the assay sensitivity criteria outlined in ICH Guidance E14 by having a lower confidence bound of ≥5 ms. The results of a linear exposure-response model which were similar to that of a time point analysis demonstrated a slightly positive relationship between contezolid plasma levels and ΔQTcF interval with a slope of 0.227 ms per mg/liter (90% CI, 0.188 to 0.266). In summary, contezolid did not prolong the QT interval at a therapeutic dose and may have a slight effect on QT interval prolongation at a supratherapeutic dose.",2020,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"['52 healthy subjects who were administered', 'healthy Chinese volunteers']","['placebo', 'placebo, and oral moxifloxacin', 'moxifloxacin', 'oral contezolid', 'supratherapeutic', 'contezolid (MRX-I']","['QT interval prolongation', 'contezolid plasma levels and ΔQTcF interval', 'QT interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",52.0,0.16154,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"[{'ForeName': 'Junzhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Hailan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Beining', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Kanhong', 'Initials': 'K', 'LastName': 'Ni', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}, {'ForeName': 'Yuewen', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02158-19'] 511,32229754,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial.,"BACKGROUND Postdischarge nausea and vomiting after ambulatory surgery is a common problem that is not adequately addressed in current practice. This prospective, randomized, double-blind, parallel-group, placebo-controlled study was designed to test the hypothesis that oral olanzapine is superior to placebo at preventing postdischarge nausea and vomiting. METHODS In a single-center, double-blind, randomized, placebo-controlled trial, the authors compared a single preoperative dose of olanzapine 10 mg to placebo, in adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and ondansetron. The primary composite outcome was nausea and/or vomiting in the 24 h after discharge. Secondary outcomes included severe nausea, vomiting, and side effects. RESULTS A total of 140 patients were randomized and evaluable. The primary outcome occurred in 26 of 69 patients (38%) in the placebo group and in 10 of 71 patients (14%) in the olanzapine group (relative risk, 0.37; 95% CI, 0.20 to 0.72; P = 0.003). Severe nausea occurred in 14 patients (20%) in the placebo group and 4 patients (6%) in the olanzapine group (relative risk, 0.28; 95% CI, 0.10 to 0.80). Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10). The median score for sedation (scale 0 to 10, with 10 being highest) in the 24 h after discharge was 4 (interquartile range, 2 to 7) in the placebo group and 6 (interquartile range, 3 to 8) in the olanzapine group (P = 0.023). CONCLUSIONS When combined with ondansetron and dexamethasone, the addition of olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 hafter discharge from ambulatory surgery by about 60% with a slight increase in reported sedation.",2020,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","['140 patients were randomized and evaluable', 'after Ambulatory Surgery', 'adult female patients 50 years old or less, undergoing ambulatory gynecologic or plastic surgery with general anesthesia']","['dexamethasone and ondansetron', 'Olanzapine', 'placebo', 'olanzapine 10 mg to placebo', 'olanzapine', 'ondansetron and dexamethasone']","['Severe nausea', 'Postdischarge Nausea and Vomiting', 'nausea and vomiting', 'postdischarge nausea and vomiting', 'Vomiting', 'risk of nausea and/or vomiting', 'median score for sedation', 'severe nausea, vomiting, and side effects', 'nausea and/or vomiting']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0038911', 'cui_str': 'Surgery, Plastic'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",140.0,0.74613,"Vomiting occurred in eight patients (12%) in the placebo group and two patients (3%) in the olanzapine group (relative risk, 0.24; 95% CI, 0.05 to 1.10).","[{'ForeName': 'Jaime B', 'Initials': 'JB', 'LastName': 'Hyman', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine (J.B.H., C.P., B.C., M.H., S.D.) Department of Population Health Science and Policy (H.-M.L.) Division of Gynecology, Department of Obstetrics, Gynecology and Reproductive Science (L.R., R.L.B.G., V.P., C.A.-W.) Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Blavatnik Family Women's Health Research Institute (S.V.B.) Division of Plastic and Reconstructive Surgery, Department of Surgery (P.J.T.), Icahn School of Medicine at Mount Sinai, New York, New York Suzanne Fenske, M.D., P.C., Brookville, New York (S.S.F.) Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts (S.B.P.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hung-Mo', 'Initials': 'HM', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Fenske', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Barr Grzesh', 'Affiliation': ''}, {'ForeName': 'Stephanie V', 'Initials': 'SV', 'LastName': 'Blank', 'Affiliation': ''}, {'ForeName': 'Sylvie B', 'Initials': 'SB', 'LastName': 'Polsky', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hartnett', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Taub', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Palvia', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'DeMaria', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ascher-Walsh', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003286'] 512,31498264,Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,"BACKGROUND Tranexamic acid (TXA) is efficacious for reducing blood loss and transfusion use in patients who undergo bilateral TKA, and it is administered intravenously alone, intraarticularly alone, or as a combination of these. However, it is unclear whether combined intravenous (IV) and intraarticular TXA offers any additional benefit over intraarticular use alone in patients undergoing bilateral TKA. QUESTIONS/PURPOSES The purposes of our study was to determine (1) whether combined IV and intraarticular TXA reduces blood loss and blood transfusion use compared with intraarticular use alone and (2) whether the frequency of adverse events is different between these routes of administration in patients who undergo simultaneous or staged bilateral TKA. METHODS Between April 2015 and May 2017, one surgeon performed 316 same-day bilateral TKAs and 314 staged bilateral TKAs. Of those, 98% of patients in each same-day TKA (310) and staged bilateral TKA (309) groups were eligible for this randomized trial and all of those patients agreed to participate and were randomized. The study included four groups: simultaneous TKA with intraarticular TXA only (n = 157), simultaneous TKA with IV and intraarticular TXA (n = 153), staged TKA with intraarticular TXA only (n = 156), and staged TKA with IV and intraarticular TXA (n = 155). There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values. The primary outcome variables were total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion. The secondary outcomes of this study were a decrease in the postoperative hemoglobin level; the proportion of patients with a hemoglobin level lower than 7.0, 8.0, or 9.0 g/dL; and the frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection. RESULTS Total blood loss with intraarticular TXA alone in patients undergoing simultaneous bilateral TKA and those undergoing staged procedures was not different from the total blood loss with the combined IV plus intraarticular TXA regimen (1063 mL ± 303 mL versus 1004 mL ± 287 mL, mean difference 59 mL [95% CI -7 to 125]; p = 0.08 and 909 ml ± 283 ml versus 845 ml ± 278 ml; mean difference 64 mL [95% CI 1 to 127]; p = 0.046, respectively). The use of blood transfusions between intraarticular alone and combined IV and intraarticular TXA was also not different among patients undergoing simultaneous (0% [0 of 152] versus 1%; p = 0.149) and staged TKA (1% [1 of 155] versus 0% [0 of 153]; p = 0.98). Furthermore, the frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections was low, without any differences among the groups with the numbers available. CONCLUSION Because there was no difference between intraarticular alone and combined intraarticular plus IV regimen of TXA administration, we recommend that IV and intraarticular TXA should not be used in combination. Moreover, other studies have found no differences between intraarticular and IV TXA used alone, and hence to avoid potential complications associated with systemic administration, we recommend that intraarticular alone is sufficient for routine TKA. LEVEL OF EVIDENCE Level I, therapeutic study.",2020,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","['Bilateral TKA', 'patients who undergo simultaneous or staged bilateral TKA', 'patients who undergo bilateral TKA', 'patients undergoing bilateral TKA', 'Between April 2015 and May 2017']","['intraarticular TXA', 'combined intravenous (IV) and intraarticular TXA', 'combined IV and intraarticular TXA', 'staged TKA with intraarticular TXA', 'TKA with intraarticular TXA', 'Intraarticular Tranexamic Acid', 'Tranexamic acid (TXA', 'staged TKA with IV and intraarticular TXA', 'TXA administration', 'IV and intraarticular TXA', 'intraarticular alone and combined IV and intraarticular TXA', 'simultaneous TKA with IV and intraarticular TXA', 'TXA']","['demographic data', 'blood loss and blood transfusion', 'total blood loss', 'blood transfusions', 'Total blood loss', 'frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections', 'postoperative hemoglobin level; the proportion of patients with a hemoglobin level', 'total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion', 'frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1096106'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",316.0,0.107007,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000942'] 513,31500557,Gait-Synchronized Rhythmic Brain Stimulation Improves Poststroke Gait Disturbance: A Pilot Study.,"Background and Purpose- Gait disturbance is one of serious impairments lowering activity of daily life in poststroke patients. The patients often show reduced hip and knee joint flexion and ankle dorsiflexion of the lower limbs during the swing phase of gait, which is partly controlled by the primary motor cortex (M1). In the present study, we investigated whether gait-synchronized rhythmic brain stimulation targeting swing phase-related M1 activity can improve gait function in poststroke patients. Methods- Eleven poststroke patients in the chronic phase participated in this single-blind crossover study. Each patient received oscillatory transcranial direct current stimulation over the affected M1 foot area and sham stimulation during treadmill gait. The brain stimulation was synchronized with individual gait rhythm, and the electrical current peaks reached immediately before initiation of the swing phase of the paretic lower limb. Ankle dorsiflexion was assisted by electrical neuromuscular stimulation in both real and sham conditions. Results- Regarding the effects of a single intervention, the speed of self-paced gait was significantly increased after oscillatory transcranial direct current stimulation, but not after sham stimulation (paired t test, P =0.009). After we administered the intervention repeatedly, self- and maximally paced gait speed and timed up and go test performance were significantly improved (self-paced: F (1,21) =8.91, P =0.007, maximally paced: F (1,21) =7.09, P =0.015 and timed up and go test: F (1,21) =12.27, P =0.002), along with improved balance function and increased joint flexion of the paretic limbs during gait. Conclusions- These findings suggest that rhythmic brain stimulation synchronized with gait rhythm might be a promising approach to induce gait recovery in poststroke patients. Clinical Trial Registration- URL: https://www.umin.ac.jp/ctr/. Unique identifier: UMIN000013676.",2019,"The patients often show reduced hip and knee joint flexion and ankle dorsiflexion of the lower limbs during the swing phase of gait, which is partly controlled by the primary motor cortex (M1).","['Methods- Eleven poststroke patients in the chronic phase participated', 'poststroke patients']","[' and Purpose', 'gait-synchronized rhythmic brain stimulation targeting swing phase-related M1 activity', 'Gait-Synchronized Rhythmic Brain Stimulation', 'oscillatory transcranial direct current stimulation over the affected M1 foot area and sham stimulation during treadmill gait', 'Conclusions']","['gait function', 'Poststroke Gait Disturbance', 'balance function and increased joint flexion of the paretic limbs during gait', 'self- and maximally paced gait speed and timed up and go test performance', 'hip and knee joint flexion and ankle dorsiflexion of the lower limbs', 'speed of self-paced gait']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0575081', 'cui_str': 'Gait difficulty'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.106483,"The patients often show reduced hip and knee joint flexion and ankle dorsiflexion of the lower limbs during the swing phase of gait, which is partly controlled by the primary motor cortex (M1).","[{'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Koganemaru', 'Affiliation': 'From the Department of Physiology and Biological Information, Dokkyo Medical University, Tochigi, Japan (S.K., K.K.).'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kitatani', 'Affiliation': 'Kansai Rehabilitation Hospital, Osaka, Japan (R.K., A.F.-M.).'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Fukushima-Maeda', 'Affiliation': 'Kansai Rehabilitation Hospital, Osaka, Japan (R.K., A.F.-M.).'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mikami', 'Affiliation': 'Human Brain Research Center (Y.M., M.M.), The Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okita', 'Affiliation': 'Department of Physical Therapy (R.K., Y.O., K.O.), The Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Matsuhashi', 'Affiliation': 'Human Brain Research Center (Y.M., M.M.), The Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Physical Therapy (R.K., Y.O., K.O.), The Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kansaku', 'Affiliation': 'From the Department of Physiology and Biological Information, Dokkyo Medical University, Tochigi, Japan (S.K., K.K.).'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Mima', 'Affiliation': 'The Graduate School of Core Ethics and Frontier Sciences, Ritsumeikan University, Kyoto, Japan (T.M.).'}]",Stroke,['10.1161/STROKEAHA.119.025354'] 514,30874766,"Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.","Importance Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P < .001). Conclusions and Relevance Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. Trial Registration ClinicalTrials.gov Identifier: NCT00911508.",2019,"However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. ","['126 centers in 10 countries', '2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF', 'patients with AF', 'Patients With Atrial Fibrillation', '2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017']","['catheter ablation', 'conventional medical therapy', 'Catheter Ablation vs Antiarrhythmic Drug Therapy', 'standard rhythm and/or rate control drugs guided by contemporaneous guidelines', 'Importance\n\n\nCatheter ablation', 'pulmonary vein isolation']","['cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence', 'catheter ablation', 'death, disabling stroke, serious bleeding, or cardiac arrest', 'composite of death, disabling stroke, serious bleeding, or cardiac arrest', 'Mortality, Stroke, Bleeding, and Cardiac Arrest', 'death or cardiovascular hospitalization']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",2204.0,0.143549,"However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. ","[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Robb', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yves D', 'Initials': 'YD', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Jeffries', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'L Brent', 'Initials': 'LB', 'LastName': 'Mitchell', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada.'}, {'ForeName': 'Greg C', 'Initials': 'GC', 'LastName': 'Flaker', 'Affiliation': 'University of Missouri, Columbia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Pokushalov', 'Affiliation': 'E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Romanov', 'Affiliation': 'E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.'}, {'ForeName': 'T Jared', 'Initials': 'TJ', 'LastName': 'Bunch', 'Affiliation': 'Intermountain Health Care, Salt Lake City, Utah.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Noelker', 'Affiliation': 'Herz-und Diabeteszentru, Bad Oeynhausen, Germany.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Ardashev', 'Affiliation': 'Medical Science Center of Moscow State University, Moscow, Russia.'}, {'ForeName': 'Amiran', 'Initials': 'A', 'LastName': 'Revishvili', 'Affiliation': 'Bakoulev Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wilber', 'Affiliation': 'Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cappato', 'Affiliation': 'Humanitas Rozzano-Milano, Milan, Italy.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Leipzig Heart Center, Leipzig, Germany.'}, {'ForeName': 'D Wyn', 'Initials': 'DW', 'LastName': 'Davies', 'Affiliation': 'St Marys Hospital, London, United Kingdom.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Kowey', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Wynnewood, Pennsylvania.'}, {'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Penn State University, Hershey, Pennsylvania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Reiffel', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.0693'] 515,32227179,Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.,"Importance There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care. Objective To examine whether default options in ADs influence care choices and clinical outcomes. Design, Setting, and Participants This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019. Interventions Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD). Main Outcomes and Measures This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care. Results Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes. Conclusions and Relevance In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT02017548.",2020,"There were no differences among groups in other secondary outcomes. ","['Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months', 'November 2018 to April 2019', '515 patients who met criteria for having serious illness and agreed to participate', '515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer', 'Seriously Ill Patients', '492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the']","['comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD']","['comfort care', 'life-extending AD chose comfort care', ""choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care"", 'Hospital-Free Days and Care Choices', 'legally valid ADs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0150521', 'cui_str': 'Comfort Care'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0421611', 'cui_str': 'Place of death (observable entity)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",515.0,0.193088,"There were no differences among groups in other secondary outcomes. ","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cooney', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bayes', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tomko', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1742'] 516,31982494,Financial Incentives for Smoking Cessation in Hospitalized Patients: A Randomized Clinical Trial.,"BACKGROUND Financial incentives for smoking cessation and use of evidence-based therapy may increase quitting rates and reduce health and economic disparities. METHODS We randomized a low-income population of 182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral or enhanced usual care plus financial incentives. All patients received enhanced usual care, while participants randomized to the financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically confirmed smoking cessation at 2 months ($150) and 6 months ($250). Primary outcome was biochemically confirmed smoking cessation at 6 months after hospital discharge. RESULTS Total mean payment was $84 (standard deviation [SD] = $133) in the incentive group. The 6-month rate of biochemically confirmed smoking cessation was 19.6% in the incentive group and 8.9% in the enhanced usual care group (odds ratio [OR] 2.56; 95% confidence interval [CI] 0.84 to 7.83, P = 0.10). Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% vs 31.3%, P = 0.002). Financial incentives did not improve subjective social status but did increase financial stress. CONCLUSIONS Rates of bioconfirmed smoking cessation were higher among hospitalized patients randomized to financial incentives compared to usual care alone, but the difference was not significant. Considering the frequency of low payouts and the importance of assistance for successful quitting, future studies should explore the effectiveness of financial incentives sufficiently large to overcome barriers to evidence-based therapy.",2020,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","['Hospitalized Patients', '182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral, or enhanced usual care plus financial incentives']","['financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically-confirmed smoking cessation']","['6-month rate of biochemically-confirmed smoking cessation', 'higher rates of nicotine replacement therapy use', 'subjective social status', 'financial stress', 'biochemically-confirmed smoking cessation at 6 months after hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",182.0,0.123893,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles; Department of Population Health, New York University School of Medicine, New York. Electronic address: jladapo@mednet.ucla.edu.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York; Department of Medicine, VA New York Harbor Healthcare System, New York; Department of Medicine, New York University School of Medicine, New York.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.025'] 517,32105387,Metabo- and mechanoreceptor expression in human heart failure: Relationships with the locomotor muscle afferent influence on exercise responses.,"NEW FINDINGS What is the central question of this study? How do locomotor muscle metabo- and mechanoreceptor expression compare in heart failure patients and controls? Do relationships exist between the protein expression and cardiopulmonary responses during exercise with locomotor muscle neural afferent feedback inhibition? What is the main finding and its importance? Heart failure patients exhibited greater protein expression of transient receptor potential vanilloid type 1 and cyclooxygenase-2 than controls. These findings are important as they identify receptors that may underlie the augmented locomotor muscle neural afferent feedback in heart failure. ABSTRACT Heart failure patients with reduced ejection fraction (HFrEF) exhibit abnormal locomotor group III/IV afferent feedback during exercise; however, the underlying mechanisms are unclear. Therefore, the purpose of this study was to determine (1) metabo- and mechanoreceptor expression in HFrEF and controls and (2) relationships between receptor expression and changes in cardiopulmonary responses with afferent inhibition. Ten controls and six HFrEF performed 5 min of cycling exercise at 65% peak workload with lumbar intrathecal fentanyl (FENT) or placebo (PLA). Arterial blood pressure and catecholamines were measured via radial artery catheter. A vastus lateralis muscle biopsy was performed to quantify cyclooxygenase-2 (COX-2), purinergic 2X 3 (P2X 3 ), transient receptor potential vanilloid type 1 (TRP V 1), acid-sensing ion channel 3 (ASIC 3 ), Piezo 1 and Piezo 2 protein expression. TRP V 1 and COX-2 protein expression was greater in HFrEF than controls (both P < 0.04), while P2X 3 , ASIC 3 , and Piezo 1 and 2 were not different between groups (all P > 0.16). In all participants, COX-2 protein expression was related to the percentage change in ventilation (r = -0.66) and mean arterial pressure (MAP) (r = -0.82) (both P < 0.01) with FENT (relative to PLA) during exercise. In controls, TRP V 1 protein expression was related to the percentage change in systolic blood pressure (r = -0.77, P = 0.02) and MAP (r = -0.72, P = 0.03) with FENT (relative to PLA) during exercise. TRP V 1 and COX-2 protein levels are elevated in HFrEF compared to controls. These findings suggest that the elevated TRP V 1 and COX-2 expression may contribute to the exaggerated locomotor muscle afferent feedback during cycling exercise in HFrEF.",2020,"Results TRP V 1 and COX-2 protein expression were greater in HFrEF than controls (both, p < 0.04), while P2X 3 , ASIC 3 , and Piezo 1 and 2 were not different between groups (all, p > 0.16).","['human heart failure', 'heart failure patients and controls', 'Heart failure patients with reduced ejection fraction (HFrEF) exhibit abnormal locomotor group III/IV afferent feedback during exercise']","['HFrEF performed 5\xa0min of cycling exercise at 65% peak workload with lumbar intrathecal fentanyl (FENT) or placebo (PLA', 'MAP', 'FENT']","['protein expression of TRP V 1 and COX-2', 'COX-2 protein expression', 'Arterial blood pressure (BP) and catecholamines', 'Results TRP V 1 and COX-2 protein expression', 'Conclusion TRP V 1 and COX-2 protein levels', 'SBP']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",10.0,0.0214929,"Results TRP V 1 and COX-2 protein expression were greater in HFrEF than controls (both, p < 0.04), while P2X 3 , ASIC 3 , and Piezo 1 and 2 were not different between groups (all, p > 0.16).","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Hart', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Ramos', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joshua G', 'Initials': 'JG', 'LastName': 'Akinsanya', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Lanza', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Olson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.'}]",Experimental physiology,['10.1113/EP088353'] 518,32227368,Weight suppression and weight maintenance following treatment of anorexia nervosa.,"OBJECTIVE The value of weight suppression (WS) in predicting the course of anorexia nervosa (AN) is uncertain. The objective of this study was to determine, using data from a previously published study, whether patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse. METHOD Following weight restoration, 93 women with AN were randomly assigned to receive fluoxetine or placebo along with cognitive behavioral therapy for 1 year. WS (highest adult weight minus current weight), body mass index (BMI), and their interaction were assessed as predictors of change in weight over the first 28 days, of successful weight maintenance at 6 and 12 months, and of time to relapse. RESULTS Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge. DISCUSSION This study found that WS does not substantially impact the likelihood of successful weight maintenance or time to relapse following restoration to a minimally normal weight in AN.",2020,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge. ","['93 women with AN', 'anorexia nervosa', 'patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse']","['fluoxetine or placebo', 'weight suppression (WS', 'cognitive behavioral therapy']","['Weight suppression and weight maintenance', 'successful weight maintenance', 'time to relapse, or weight change', 'WS (highest adult weight minus current weight), body mass index (BMI), and their interaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",93.0,0.0544804,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge. ","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Uniacke', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23269'] 519,31891860,Acute alcohol intake alters resting state functional connectivity of nucleus accumbens with pain-related corticolimbic structures.,"BACKGROUND The nucleus accumbens (NAc) is a ventral striatal structure underlying reward, reinforcement, and motivation, with extensive anatomic and functional connections to a wide range of affective processing structures (medial prefrontal cortex (mPFC), amygdala, and insula). Characterizing how acute alcohol intake affects resting state functional connectivity (rsFC) between the nucleus accumbens (NAc) and these regions will improve mechanistic understanding of alcohol's neurobehavioral effects, including the neural overlap between acute alcohol effects and pain processing. METHODS Fifteen healthy social drinkers (10 women; age: 25-45 years) were included in the study. Participants completed one session in which they consumed an alcohol dose targeting a breath alcohol concentration of 0.08 g/dL, and in a second a placebo beverage. Nine-minute resting state fMRI scans were acquired 30-35 min after beverage administration during each session. rsFC between NAc and a priori corticolimbic regions of interest (mPFC, amgydala, and insula), were compared between beverage conditions. We also conducted an exploratory whole-brain seed-to-voxel analysis of NAc FC. RESULTS Alcohol intake reduced rsFC between NAc and mPFC, as well as NAc and amygdala. Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex. CONCLUSIONS Findings suggest that acute alcohol intake reduces rsFC between NAc and several structures, including mPFC, amygdala, and rostral ACC in healthy social drinkers. These structures underlie reward, motivated behavior, and emotion regulation, and may provide mechanistic insight to how alcohol affects related processes, including pain.",2020,"Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex. ","['healthy social drinkers', 'Fifteen healthy social drinkers (10 women; age: 25-45 years']","['Acute alcohol intake', 'placebo beverage']",[],"[{'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]",[],15.0,0.0751021,"Alcohol also reduced rsFC between NAc and a 97-voxel cluster including bilateral paracingulate cortex and anterior cingulate cortex. ","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA. Electronic address: jboissoneault@phhp.ufl.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stennett', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107811'] 520,30614551,Hormonal and metabolic effects of carbohydrate restriction in children with Prader-Willi syndrome.,"OBJECTIVE Macronutrient regulation of hyperphagia and adiposity in Prader-Willi syndrome (PWS) is poorly understood. We compared fasting and postprandial concentrations of hormones and metabolites in eight PWS children (age 9-18 years) fed, in random order, low carbohydrate, high-fat (LC, 15% carb; 65% fat; 20% protein) and low-fat, high carbohydrate (LF, 65% carb, 15% fat, 20% protein) diets matched for calories and protein. METHODS Participants were randomized to consume either the LC or LF diet during a first hospital admission and the second diet during a subsequent admission. Blood samples were obtained after overnight fasting and 1 hour after a mixed meal. RESULTS Relative to subjects consuming the LF diet, subjects consuming the LC diet had: lower postprandial insulin concentrations (P = 0.02); higher fasting GLP-1 AND GIP concentrations and increased postprandial GLP-1 (P < 0.02); reduced ratio of fasting ghrelin to GLP-1 (P = 0.0078); increased FFA and fatty acid oxidation, as assessed by concentrations of even-chain acylcarnitines (P < 0.001); lower fasting TG and TG/HDL ratio (P < 0.01); and higher concentrations of branch chain amino acids (P < 0.01). There were no changes in glucose, PYY, or adiponectin. CRP, AST and ALT were all higher (P < 0.01) on the LC diet. CONCLUSIONS Increases in GLP-1 with low carbohydrate feeding and reductions in the ratio of ghrelin to GLP-1 might limit food intake and improve glycaemic control in PWS. Other potential benefits of carbohydrate restriction may include fat mobilization and oxidation and reductions in the TG/HDL ratio, a marker of insulin resistance. However, increases in CRP, AST and ALT necessitate longer-term studies of low carbohydrate efficacy and safety.",2019,< 0.02); reduced ratio of fasting ghrelin to GLP-1,"['eight PWS children (age 9-18\xa0years) fed, in random order, low carbohydrate, high-fat (LC, 15% carb; 65% fat; 20% protein) and', 'Prader-Willi syndrome (PWS', 'children with Prader-Willi syndrome', 'Participants']","['LC or LF diet', 'carbohydrate restriction', 'low-fat, high carbohydrate (LF, 65% carb, 15% fat, 20% protein) diets matched for calories and protein']","['FFA and fatty acid oxidation', 'Blood samples', 'CRP, AST and ALT', 'fasting TG and TG/HDL ratio', 'postprandial insulin concentrations', 'ratio of fasting ghrelin to GLP-1', 'glucose, PYY, or adiponectin', 'fasting GLP-1 AND GIP concentrations and increased postprandial GLP-1', 'higher concentrations of branch chain amino acids', 'concentrations of even-chain acylcarnitines']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}]",8.0,0.0231585,< 0.02); reduced ratio of fasting ghrelin to GLP-1,"[{'ForeName': 'Krystal A', 'Initials': 'KA', 'LastName': 'Irizarry', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Diana R', 'Initials': 'DR', 'LastName': 'Mager', 'Affiliation': 'Department of Agricultural, Food, and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lucila', 'Initials': 'L', 'LastName': 'Triador', 'Affiliation': 'Division of Pediatric Endocrinology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Muehlbauer', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Haqq', 'Affiliation': 'Division of Pediatric Endocrinology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, Durham, North Carolina.'}]",Clinical endocrinology,['10.1111/cen.13933'] 521,32224129,Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease.,"BACKGROUND & AIMS We investigated the effects of inducing deep remission in patients with early Crohn's disease (CD). METHODS We collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period. RESULTS Major adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome. CONCLUSIONS In an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.",2020,Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P=.01).,"['Fifty percent of patients (n=61', ""patients with early Crohn's disease (CD"", 'below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median 3.02 y; range, 0.05-6.26 y', '122 patients (mean age, 31.2±11.3 y) with early, moderate to severe CD (median duration 0.2 y; interquartile range, 0.1-0.5 y) who participated in the effect of tight control management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population']",['tight control strategy (increased therapy'],"['composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD', 'Deep Remission', 'deep remission', 'major adverse outcomes', 'composite rates', 'deep remission (CD endoscopic index of severity scores']","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0333330', 'cui_str': 'Internal fistula (morphologic abnormality)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0267561', 'cui_str': 'Fistula of perianal skin'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",122.0,0.0825621,Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P=.01).,"[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Ungaro', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Yzet', 'Affiliation': 'Amiens University Hospital, Department of Gastroenterology, Amiens, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Imelda Gastroenterology Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Filip J', 'Initials': 'FJ', 'LastName': 'Baert', 'Affiliation': 'AZ Delta Roeselare, Roeselare, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanasek', 'Affiliation': 'Second Department of Internal Medicine, University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent Wilhelmus', 'Initials': 'VW', 'LastName': 'Joustra', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Gottfried', 'Initials': 'G', 'LastName': 'Novacek', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'Inflammatory Bowel Disease Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Golovchenko', 'Affiliation': 'Medical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Prymak', 'Affiliation': 'Medical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Goldis', 'Affiliation': 'Universitatea de Medicina si Farmacie, Timisoara, Romania.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Travis', 'Affiliation': 'Translational Gastroenterology Unit, Nuffield Department of Experimental Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hébuterne', 'Affiliation': 'Gastroenterology and Clinical Nutrition Department, CHU of Nice, University of Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Rogler', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Amiens University Hospital, Department of Gastroenterology, Amiens, France.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Humanitas University, Istituto Clinico Humanitas, Milan, Italy.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Rydzewska', 'Affiliation': 'Central Clinical Hospital of Ministry of Interior and Administration in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pariente', 'Affiliation': 'Claude Huriez Hospital, Lille University, Lille, France.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hertervig', 'Affiliation': 'Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stanciu', 'Affiliation': 'Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Serrero', 'Affiliation': 'Hepato-Gastroenterology Department, North Hospital, University of Mediterranean, Marseille, France.'}, {'ForeName': 'Mircea', 'Initials': 'M', 'LastName': 'Diculescu', 'Affiliation': 'University of Medicine and Pharmacy ""Carol Davila,"" Bucharest, Romania.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Hépato Gastro-Entérologie, Hôpital de Brabois, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': ""Service d'Hépato-gastroentérologie et Oncologie Digestive, Hôpital Haut-Lévêque, Bordeaux, France.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Wright', 'Affiliation': 'Kingsbury Hospital, Cape Town, South Africa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomollón', 'Affiliation': 'Hospital Clínico de Zaragoza, IIS Aragón, Zaragoza, Spain.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Gubonina', 'Affiliation': 'Military Medical Academy named after S.M. Kirov, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Department of Internal Medicine I, Kiel University, Kiel, Germany.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'Inflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Sapporo, Japan.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Halfvarson', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Butler', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Petersson', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Petralia', 'Affiliation': 'Department of Genetics and Genomic Sciences and Icahn Institute for Data Science and Genomic Technology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York. Electronic address: jean-frederic.colombel@mssm.edu.'}]",Gastroenterology,['10.1053/j.gastro.2020.03.039'] 522,32224945,Movement Competency Training Delivery: At School or Online? A Pilot Study of High-School Athletes.,"Movement competency (MC) development of high-school athletes can prepare them for the requirements of physical preparation training and the demands of sport. The aim of this study was to explore the physical effects of and athlete compliance to coach-led versus self-directed training approaches in this population. Thirty-nine high-school athletes (19 male, 14.5 ± 0.3 years old; 20 female, 14.6 ± 0.3 years) were allocated into two groups for a physical preparation program to improve MC. Groups were prescribed either (i) one face-to-face and one online (F2F, n = 18), or (ii) two online (OL, n = 21) sessions per week for 16-weeks. Before and after the intervention, the Athlete Introductory Movement Screen (AIMS) was used to assess MC alongside common physical capacity measures (triple-hop, star-excursion balance, medicine ball throw, 40m sprint and countermovement jump). Dropout left 22 participants with pre-post physical scores. Compliance with online training was low and F2F session attendance moderate. Semi-structured interviews were conducted to assess participant perceptions following the intervention. Assessing individual responses, the F2F group had a higher proportion of positive responders to AIMS scores, yet capacity measures were inconclusive across groups. Face-to-face coaching when acquiring MCs as part of physical preparation, may provide greater positive perceptions towards training compared to self-directed online prescriptions, and thereby greater compliance.",2020,"Assessing individual responses, the F2F group had a higher proportion of positive responders to AIMS scores, yet capacity measures were inconclusive across groups.","['Thirty-nine high-school athletes (19 male, 14.5 ± 0.3 years old; 20 female, 14.6 ± 0.3 years', 'Dropout left 22 participants with pre-post physical scores', 'high-school athletes', 'High-School Athletes']","['coach-led versus self-directed training approaches', 'Movement Competency Training Delivery', 'physical preparation program to improve MC']",[],"[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",[],22.0,0.0209938,"Assessing individual responses, the F2F group had a higher proportion of positive responders to AIMS scores, yet capacity measures were inconclusive across groups.","[{'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Rogers', 'Affiliation': 'School of Health & Human Sciences, Southern Cross University, Lismore 2480, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hassmén', 'Affiliation': 'School of Health & Human Sciences, Southern Cross University, Lismore 2480, NSW, Australia.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Roberts', 'Affiliation': 'Applied Technology and Innovation, Australian Institute of Sport, Bruce, 2617 ACT, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Alcock', 'Affiliation': 'School of Health & Human Sciences, Southern Cross University, Lismore 2480, NSW, Australia.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Gilleard', 'Affiliation': 'School of Health & Human Sciences, Southern Cross University, Lismore 2480, NSW, Australia.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Warmenhoven', 'Affiliation': 'Applied Technology and Innovation, Australian Institute of Sport, Bruce, 2617 ACT, Australia.'}]","Sports (Basel, Switzerland)",['10.3390/sports8040039'] 523,32057988,Arthroscopy-Assisted Reduction in the Management of Isolated Medial Malleolar Fracture.,"PURPOSE To evaluate the feasibility of arthroscopic reduction percutaneous fixation (ARPF) in the treatment of isolated medial malleolar fracture and compare the results with those of conventional open reduction internal fixation (ORIF). METHODS This prospective study enrolled 77 patients with isolated medial malleolar fracture between November 2011 and February 2016. The patients were assigned to the ARPF (n = 34) and ORIF (n = 43) groups. The Olerud-Molander ankle score (OMAS), ankle range of motion (ROM), visual analog scale, and radiographic evaluation were determined at the scheduled follow-up. RESULTS In the ARPF group, 11 of 34 patients (32.4%) had chondral lesions. Tears of the deltoid ligament and anterior inferior tibiofibular ligament were noted in 3 (8.8%) and 15 (44.1%) patients, respectively. The mean follow-up was 5 years. The mean OMAS was higher in the ARPF group than in the ORIF group. The differences were statistically significant at 6 months (mean ± standard deviation, 80.2 ± 4.0 for ARPF vs 77.2 ± 4.1 for ORIF, P = .005) and 1 year (92.9 ± 4.9 vs 88.1 ± 4.6, P < .001), but not at the latest follow-up (P = .081). Ankle ROM was markedly improved in the ARPF group, unlike in the ORIF group at 6 months (dorsiflexion, P = .025; plantarflexion, P < .001) and 1 year (dorsiflexion and plantarflexion, P < .001). The improvement remained at the latest follow-up in plantarflexion (P = .001) but not in dorsiflexion (P = .354). CONCLUSIONS Arthroscopy-assisted reduction is a feasible alternative modality with superior short-term outcomes for treating isolated medial malleolar fracture, but its superiority may be attenuated in the intermediate term. LEVEL OF EVIDENCE Level III, comparative study.",2020,"The improvement remained present at the latest follow-up in plantar flexion (P = 0.001) but not in dorsiflexion (P = 0.354). ","['77 patients with isolated medial malleolar fracture between November 2011 and February 2016', 'isolated medial malleolar fracture']","['arthroscopic reduction percutaneous fixation (ARPF', 'conventional open reduction internal fixation (ORIF', 'ORIF', 'ARPF', 'Arthroscopy-assisted reduction']","['Ankle ROM', 'mean OMAS', 'plantar flexion', 'Olerud-Molander Ankle Score (OMAS), ankle range of motion (ROM), visual analog scale, and radiographic evaluation', 'chondral lesions', 'Tears of the deltoid ligament and anterior inferior tibiofibular ligament']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0442012', 'cui_str': 'Chondral (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}, {'cui': 'C3661495', 'cui_str': 'Anterior Inferior Tibiofibular Ligament'}]",77.0,0.0301002,"The improvement remained present at the latest follow-up in plantar flexion (P = 0.001) but not in dorsiflexion (P = 0.354). ","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Jia-Xing', 'Initials': 'JX', 'LastName': 'You', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Hai-Feng', 'Initials': 'HF', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'He-Jun', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China.'}, {'ForeName': 'Shun-Wu', 'Initials': 'SW', 'LastName': 'Fan', 'Affiliation': 'Key Laboratory of Musculoskeletal System Degeneration and Regeneration Translational Research of Zhejiang Province, Hangzhou 310016, China.'}, {'ForeName': 'Hong-Ye', 'Initials': 'HY', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou 310016, China. Electronic address: zjuyjx@zju.edu.cn.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.01.053'] 524,31485929,"Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.","BACKGROUND The transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery. METHODS This was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively. RESULTS 60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. TRIAL REGISTRY The trial was registered at clinicaltrials.gov Identifier NCT03577912.",2020,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. ","['patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing', '60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively']","['LTAP vs. UTAP', 'Surgeon-delivered laparoscopic transversus abdominis plane blocks', 'laparoscopic guidance for TAP block placement (LTAP', 'conventional ultrasound-guided TAP (UTAPs', 'anesthesia-delivered ultrasound-guided transversus abdominis plane blocks', 'laparoscopic colorectal surgery', 'transversus abdominis plane (TAP) block']","['pain scores', 'time of PACU discharge', 'Narcotic consumption and pain scores', 'post-operative narcotic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.348947,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. ","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Curran', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Vitaliy Y', 'Initials': 'VY', 'LastName': 'Poylin', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cataldo', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Tcatald1@bidmc.harvard.edu.'}]",Surgical endoscopy,['10.1007/s00464-019-07097-y'] 525,32223318,Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial.,"BACKGROUND Patients with established coronary artery disease or peripheral artery disease often have diabetes mellitus. These patients are at high risk of future vascular events. METHODS In a prespecified analysis of the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies), we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes mellitus versus without diabetes mellitus in preventing major vascular events. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included all-cause mortality and all major vascular events (cardiovascular death, myocardial infarction, stroke, or major adverse limb events, including amputation). The primary safety end point was a modification of the International Society on Thrombosis and Haemostasis criteria for major bleeding. RESULTS There were 10 341 patients with diabetes mellitus and 17 054 without diabetes mellitus in the overall trial. A consistent and similar relative risk reduction was seen for benefit of rivaroxaban plus aspirin (n=9152) versus placebo plus aspirin (n=9126) in patients both with (n=6922) and without (n=11 356) diabetes mellitus for the primary efficacy end point (hazard ratio, 0.74, P =0.002; and hazard ratio, 0.77, P =0.005, respectively, P interaction =0.77) and all-cause mortality (hazard ratio, 0.81, P =0.05; and hazard ratio, 0.84, P =0.09, respectively; P interaction =0.82). However, although the absolute risk reductions appeared numerically larger in patients with versus without diabetes mellitus, both subgroups derived similar benefit (2.3% versus 1.4% for the primary efficacy end point at 3 years, Gail-Simon qualitative P interaction <0.0001; 1.9% versus 0.6% for all-cause mortality, P interaction =0.02; 2.7% versus 1.7% for major vascular events, P interaction <0.0001). Because the bleeding hazards were similar among patients with and without diabetes mellitus, the prespecified net benefit for rivaroxaban appeared particularly favorable in the patients with diabetes mellitus (2.7% versus 1.0%; Gail-Simon qualitative P interaction =0.001). CONCLUSIONS In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral end points in patients with and without diabetes mellitus. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes mellitus, including a 3-fold greater reduction in all-cause mortality. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01776424.",2020,"There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p interaction =0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p interaction =0.82).","['Diabetes and Cardiovascular Disease', '10,341 patients with diabetes and 17,054 without diabetes in the overall trial', 'patients with diabetes versus without diabetes in preventing major vascular events', 'Patients with established coronary artery disease (CAD) or peripheral artery disease (PAD) often have diabetes mellitus', 'patients with and without diabetes']","['aspirin', 'rivaroxaban plus aspirin', 'aspirin plus rivaroxaban', 'placebo plus aspirin', 'rivaroxaban']","['absolute risk reductions', 'coronary, cerebrovascular, and peripheral endpoints', 'composite of cardiovascular death, myocardial infarction (MI), or stroke', 'cause mortality', 'bleeding hazards', 'cause mortality and all major vascular events (cardiovascular death, MI, stroke, or major adverse limb events including amputation', 'modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding']","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",10341.0,0.29241,"There was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin (N=9,152) versus placebo plus aspirin (N=9,126) in patients both with (N=6,922) and without (N=11,356) diabetes for the primary efficacy endpoint (HR 0.74, p=0.002 and HR 0.77, p=0.005, respectively, p interaction =0.77) and all-cause mortality (HR 0.81, p=0.05 and HR 0.84, p=0.09, respectively, p interaction =0.82).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA (D.L.B.).""}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Ontario, Canada (S.V.).""}, {'ForeName': 'Kelley R H', 'Initials': 'KRH', 'LastName': 'Branch', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B., J.P.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B., J.P.).'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Shestakovska', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimský', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (P.W.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil (A.A.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina (R.D.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa (B.S.L.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ryden', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (L.R.).'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046448'] 526,32065000,CYP2C19 and CYP3A4 activity and ADP-induced platelet reactivity in prasugrel- or ticagrelor-treated STEMI patients: monocentric study in PRAGUE-18 trial participants.,"We assessed the contribution of CYP2C19 and CYP3A4 metabolic activity to the ADP-induced platelet aggregation 1h and 24h after a loading dose of 60 mg prasugrel or 180 mg ticagrelor in patients with ST-elevation myocardial infarction (STEMI). Further, we assessed the contribution of CYP2C19 polymorphisms and medication to the CYP enzymatic activity.Patients with STEMI were randomly assigned to the treatment with prasugrel ( n  = 51) or ticagrelor ( n  = 46). Metabolic activity of CYP2C19 and CYP3A4 was assessed by the rate of 5-hydroxylation and sulfoxidation of lansoprazole. Further, patients were genotyped for CYP2C19 *2 and *17 alleles.In prasugrel-treated patients, high ADP-induced platelet reactivity 1h after the loading dose positively correlated with 5OH-lansoprazole/lansoprazole ratio ( r  = 0.44, p  = 0.002), a marker of CYP2C19 metabolic activity, and negatively with lansoprazole-sulfone/lansoprazole ratio, which reflects CYP3A4 metabolic activity ( r = -0.35, p  = 0.018).CYP2C19 poor metabolizers had lower 5OH-lansoprazole/lansoprazole ratio and higher lansoprazole-sulfone/lansoprazole ratio, but without any effect on the ADP-induced platelet reactivity. The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.The CYP3A4 and CYP2C19 metabolic activity is associated with ADP-induced platelet reactivity in prasugrel-treated, but not ticagrelor-treated patients with STEMI.",2020,"The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.","['Prasugrel- or Ticagrelor-treated STEMI Patients', 'patients with ST-elevations myocardial infarction (STEMI', 'Patients with STEMI']","['ticagrelor', 'lansoprazole/lansoprazole', 'prasugrel', 'lansoprazole', 'amiodarone', 'CYP2C19', '5OH-lansoprazole/lansoprazole']","['platelet reactivity', 'ADP-induced platelet reactivity', 'Metabolic activity of CYP2C19 and CYP3A4', 'CYP3A4 metabolic activity', 'metabolic ratios nor the ADP-induced platelet reactivity', 'marker of CYP2C19 metabolic activity', 'CYP2C19 and CYP3A4 Activity and ADP-induced Platelet Reactivity']","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C3714798', 'cui_str': 'CYP3A4'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0180576,"The treatment with amiodarone, a CYP3A4 inhibitor, influenced neither the metabolic ratios nor the ADP-induced platelet reactivity.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Máchal', 'Affiliation': ""International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hlinomaz', 'Affiliation': ""International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kostolanská', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Peš', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Máchalová', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Šplíchal', 'Affiliation': 'Department of Pathophysiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': ""Mot'ovská"", 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Juřica', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2020.1731625'] 527,32128859,Randomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation.,"BACKGROUND Managing chronic constipation is challenging as patients frequently remain dissatisfied with laxative treatments. Novel studies using transabdominal electrical interferential therapy in children have shown benefit but there are inadequate adult studies. AIM To examine the effects of transabdominal interferential stimulation on bowel symptoms and quality of life in women with refractory constipation. METHODS In a single-blind, randomised, sham-controlled pilot study, women aged ≥18 years with refractory constipation were randomised to receive interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents) for 1 hour a day for 6 weeks. Primary outcome was the number of patients with ≥3 spontaneous bowel movements/week. Secondary endpoints included change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score (measured at baseline, mid time point of stimulation, end of treatment and 3 months after cessation of treatment). RESULTS Interferential therapy (n = 17) met the primary outcome in 9(53%) compared with 2(12%) with sham therapy (n = 16) (P = 0.02). Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05). Laxative use more than halved in 66% with interferential therapy compared with 14% with sham therapy (P = 0.01). Significant improvements in symptom outcomes were maintained at 3 months. There were no treatment-related adverse effects. CONCLUSION Transabdominal interferential electrical stimulation is effective in reducing constipation in adult women. Three months after therapy, response is maintained and quality of life improved. Not allowing currents to cross intra-abdominally was an effective placebo. (Australianclinicaltrials.gov.au ACTRN12614000736640).",2020,Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05).,"['women aged ≥18\xa0years with refractory constipation', 'women with functional constipation', 'women with refractory constipation', 'adult women', 'patients frequently remain dissatisfied with laxative treatments']","['transabdominal interferential stimulation', 'interferential therapy', 'interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents', 'placebo', 'Interferential therapy', 'transabdominal interferential electrical stimulation vs sham stimulation', 'transabdominal electrical interferential therapy', 'Transabdominal interferential electrical stimulation']","['symptom outcomes', 'number of patients with ≥3 spontaneous bowel movements/week', 'adverse effects', 'PAC-SYM', 'bowel symptoms and quality of life', 'overall symptom scores', 'change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0556898', 'cui_str': 'Interferential therapy (regime/therapy)'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",66.0,0.50635,Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05).,"[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Moore', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Burgell', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15642'] 528,32149424,Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis.,"BACKGROUND APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE). AIMS To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia. METHODS A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n = 8), 1.5 mg APT-1011 BID (n = 8) or 3.0 mg APT-1011 QD (n = 8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes. RESULTS There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5 mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index from baseline to end of treatment (Week 8). CONCLUSIONS APT-1011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112).",2020,"There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE.","['adults and adolescents with EoE. Participants', 'eosinophilic oesophagitis']","['fluticasone propionate orally disintegrating tablets versus placebo', 'mg APT-1011 QD ', 'placebo', 'fluticasone propionate', 'APT-1011', 'APT-1011 BID (n\xa0=\xa08) or 3.0']","['deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations', 'oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index', 'safety and tolerability', 'Safety and tolerability', 'safe and well tolerated', 'clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}]",,0.392713,"There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE.","[{'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Department of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Roumet', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Comer', 'Affiliation': 'Adare Pharmaceuticals, Lawrenceville, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Eagle', 'Affiliation': 'Adare Pharmaceuticals, Lawrenceville, NJ, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15670'] 529,32221178,Change in Defense Mechanisms and Depression in a Pilot Study of Antidepressive Medications Plus 20 Sessions of Psychotherapy for Recurrent Major Depression.,"Treatment studies of major depression commonly focus on symptoms, leaving aside change in putative psychological risk factors. This pilot study examines the relationship between changes in eight depressive defenses and depressive symptoms. Twelve adults with acute recurrent major depression were given antidepressive medications and randomized to 20 sessions of either cognitive behavioral therapy or dynamic psychotherapy and followed for 1 year. Defenses were assessed using the Defense Mechanism Rating Scales (DMRS) and Defense Style Questionnaire (DSQ) at intake, termination, and 1-year follow-up. Depression improved highly significantly on both the Hamilton Rating Scale for Depression and Beck Depression Inventory, respectively, eight (67%) and nine (75%) patients attained recovery by 1 year. Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year. A mean of 12.17% (SD = 10.60) depressive defenses remained; only five subjects (50%) attained normative levels. Although causal relationships were not established, depressive defenses are promising candidates for mediating treatment effects on outcome of major depression.",2020,"Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year.",['Twelve adults with acute recurrent major depression'],['cognitive behavioral therapy or dynamic psychotherapy'],"['Depressive defenses', 'Hamilton Rating Scale for Depression and Beck Depression Inventory', 'Defense Mechanism Rating Scales (DMRS) and Defense Style Questionnaire (DSQ) at intake, termination, and 1-year follow-up']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0011142', 'cui_str': 'Defense Mechanisms'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",12.0,0.0395845,"Depressive defenses improved significantly by termination (mean ES = 0.97; 95% confidence interval, 0.30-2.16), but retrogressed somewhat by 1 year.","[{'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Perry', 'Affiliation': 'Institute of Community and Family Psychiatry, Jewish General Hospital; and McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Banon', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bond', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001112'] 530,32221490,ART with high viscosity GIC and composite restorations in class II cavities: can they thrive in the post-amalgam era?,"Design This study is a parallel group randomised un-blinded trial with equal allocation to evaluate and compare the success of ART with HVGIC and composite restorations in class II cavities in permanent molars. Study population The study populations included 154 participants who were selected from 17 different schools of Bauru and adjoining areas in Sao Paulo, Brazil. Children with good general and oral health and having 1 or 2 class II cavities were chosen. Only one restoration per child which exhibited good occlusal contact was finally chosen for the purpose of study. The participants were then stratified as per DMFT-score and cavity size. After stratifying the participants in four conglomerates, they were randomly allocated to either ART with HVGIC or composite restoration group. Later, the participants were recalled at 6 and 12 months and the restorations were evaluated using ART and modified-USPHS criteria. Data analysis Frequency statistics, which included chi square, chi square for trend and Fisher's exact test, were used for determining the association between restoration type and different baseline variables and for determining the association between distribution of scores obtained with ART and composite restorations for different evaluation criteria. Results With ART criteria, success rates of ART and composite restoration were found to be 98.7% and 100% at 6 months while at 12 months the success rates were observed to be 98.7% and 95.8%, respectively. The distribution of scores at both the time periods was found to be statistically significant (p = 0.033). Same success rates were observed when the restorations were evaluated using modified-USPHS criteria, with statistical difference at the 6 month post-operative recall (p = 0.001), and non-significant difference at the 12 month recall visit (p = 0.310). Survival rates of ART and composite restoration were observed to be 94.8% and 98.7% with no-significant difference in the survival curves (p = 0.173)Conclusions In class II cavities in permanent molars, ART restorations with high viscosity GIC, done in a school setting exhibited similar success rates as composite restoration done in a clinical setting.",2020,The distribution of scores at both the time periods was found to be statistically significant (p = 0.033).,"['class II cavities in permanent molars', 'Study population The study populations included 154 participants who were selected from 17 different schools of Bauru and adjoining areas in Sao Paulo, Brazil', 'Children with good general and oral health and having 1 or 2 class II cavities were chosen', 'class II cavities']",['ART with HVGIC or composite restoration group'],"['Survival rates of ART and composite restoration', 'success rates of ART and composite restoration', 'survival curves', 'Same success rates', 'success rates']","[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0029162'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",154.0,0.0934285,The distribution of scores at both the time periods was found to be statistically significant (p = 0.033).,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gugnani', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DAV (C) Dental College, Yamunanagar, Haryana, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gugnani', 'Affiliation': 'Department of Periodontics and Oral Implantology, DAV (C) Dental College Yamunanagar, Haryana, India.'}]",Evidence-based dentistry,['10.1038/s41432-020-0078-6'] 531,32221496,Improving orthodontic patients' and parents' information recall with use of audio-visual presentation and mind mapping exercises.,"Design Randomised controlled trial, with blinding of operators and outcome assessors.Study population English-speaking patients aged 10 or older and parents with capacity to consent were given a 45-minute audio-visual presentation and written information on orthodontic treatment in one of three formats, either leaflets from British Orthodontic Society, generic mind map or blank mind maps.Data analysis A 30-item closed-ended questionnaire was used to test knowledge of patients and parents before (T0), at 30 minutes (T1) and 6 weeks (T2) after provision of presentation and written information. Questionnaire scores at T0, T1 and T2 were analysed using box plot, histogram and Shapiro-Wilk test.Results Ninety-three patients and 89 parents were eligible for the study, of which 88 patients (94.6%) and 77 parents (86.5%) have completed questionnaires at T0, T1 and T2. There were no significant differences in scores at T0 between the three groups. After presentation and written information were given, all three participant groups scored higher at T1 and T2. The increase in score was higher in mind map groups.Conclusions Use of audio-visual presentation and written information has improved information recall of patients and parents. The study suggests that mind maps are a superior format of written information than leaflets.",2020,There were no significant differences in scores at T0 between the three groups.,"['patients and parents', 'Study population English-speaking patients aged 10 or older and parents with capacity to consent', 'Results Ninety-three patients and 89 parents were eligible for the study, of which 88 patients (94.6%) and 77 parents (86.5%) have completed questionnaires at T0, T1 and T2']","['audio-visual presentation and mind mapping exercises', '45-minute audio-visual presentation and written information on orthodontic treatment in one of three formats, either leaflets from British Orthodontic Society, generic mind map or blank mind maps']",['Questionnaire scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",93.0,0.0333612,There were no significant differences in scores at T0 between the three groups.,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur Gakhal', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Ohsun', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}]",Evidence-based dentistry,['10.1038/s41432-020-0073-y'] 532,32222849,Correlates of Physical Activity and Cardiorespiratory Fitness in Racially and Ethnically Diverse People with Serious Mental Illness in Supportive Housing.,"We examined demographic, health, and mental health correlates of physical activity and cardiorespiratory fitness (CRF) in racially and ethnically diverse people with serious mental illness (SMI) living in supportive housing. We used baseline data from 314 people with SMI enrolled in a randomized effectiveness trial of a peer-led healthy lifestyle intervention. Sedentary behavior and physical activity were measured with the International Physical Activity Questionnaire. CRF was measured with the 6-min walking test (6MWT). Correlates were identified via ordinary least squares and logistic regressions. Participants were mostly male and racial/ethnic minorities. Thirty-four percent engaged in at least 150-min-per-week of at least moderate-intensity physical activity. On average, participants walked 316.8 m in the 6MWT. Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors. Our findings suggest subgroups and factors that can be targeted to develop health interventions to improve the physical health of people with SMI.",2020,"Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors.","['Racially and Ethnically Diverse People with Serious Mental Illness in Supportive Housing', 'Participants were mostly male and racial/ethnic minorities', '314 people with SMI enrolled', 'racially and ethnically diverse people with serious mental illness (SMI)\xa0living in supportive housing']",['peer-led healthy lifestyle intervention'],"['International Physical Activity Questionnaire', 'Physical Activity and Cardiorespiratory Fitness', 'Sedentary behavior and physical activity', 'CRF', '6-min walking test (6MWT']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",314.0,0.0856698,"Our models show that physical activity and CRF were not evenly distributed in racially and ethnically diverse people with SMI and are associated with multiple demographic, mental health, and health factors.","[{'ForeName': 'Leopoldo J', 'Initials': 'LJ', 'LastName': 'Cabassa', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA. ljcabassa@wustl.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stefancic', 'Affiliation': 'Department of Psychiatry, Columbia University, 1051 Riverside Dr., Rm 3506, New York, NY, 10031, USA.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Shenyang', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Nathaniel Young', 'Initials': 'NY', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, Columbia University, 1051 Riverside Dr., Rm 3506, New York, NY, 10031, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weatherly', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St. Louis, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, USA.'}]",Community mental health journal,['10.1007/s10597-020-00610-x'] 533,32223113,Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.,"BACKGROUND Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients. METHODS In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding. RESULTS A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P = 0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding). CONCLUSIONS Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs. (Funded by Centre Hospitalier Universitaire de Saint-Etienne and Bayer; PRONOMOS ClinicalTrials.gov number, NCT02401594.).",2020,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"['Nonmajor Orthopedic Surgery', '3604 patients underwent randomization; 1809 patients', ""adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either""]","['enoxaparin', 'Rivaroxaban', 'Rivaroxaban or Enoxaparin', 'rivaroxaban', 'rivaroxaban or enoxaparin']","['venous thromboembolic events', 'incidence of bleeding', 'major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis', 'major bleeding or nonmajor clinically relevant bleeding', 'Major venous thromboembolism', 'major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding']","[{'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",3604.0,0.445584,A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin.,"[{'ForeName': 'C Marc', 'Initials': 'CM', 'LastName': 'Samama', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rosencher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Llau', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mouret', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Martín', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duverger', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Deygas', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Cucherat', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913808'] 534,30325849,Hemoadsorption does not Have Influence on Hemolysis During Cardiopulmonary Bypass.,"Cardiopulmonary bypass (CPB) induces hemolysis, which manifests as plasma free hemoglobin. We investigated in a post hoc analysis of a single-center, blinded, controlled study whether the use of a novel hemoadsorption device (CytoSorb, CytoSorbents Europe GmbH, Berlin, Germany) affects hemolysis during CPB. A total of 35 patients undergoing elective CPB surgery with an expected CPB duration of more than 120 min were included in the analysis. The hemoadsorption device was used in 17 patients (intervention group) and not used in 18 patients (control group). The primary outcome was differences of postoperative free hemoglobin and haptoglobin levels. As secondary outcomes, we investigated differences in postoperative lactate dehydrogenase and bilirubin levels. Postoperative free hemoglobin levels were not significantly different between the groups. However, there were statistically significant differences between the treatment and control groups in the median levels of haptoglobin (58.4 vs. 17.9 mg/dL, respectively; P < 0.01) and lactate dehydrogenase (353.0 vs. 432.0 U/L, respectively; P < 0.05) on postoperative day 1. Thus, in this study, we did not find an effect on hemolysis in patients treated with hemoadsorption, though lower haptoglobin level and higher secondary hemolysis markers on postoperative day 1 in patients not treated with the hemoadsorber may be an indication of some moderate effect of the device. Studies with larger samples are needed to clarify the significance of the small differences detected in this study.",2019,Postoperative free hemoglobin levels were not significantly different between the groups.,"['17 patients (intervention group) and not used in 18 patients (control group', '35 patients undergoing elective CPB surgery with an expected CPB duration of more than 120 min were included in the analysis']",['Cardiopulmonary bypass (CPB'],"['lactate dehydrogenase', 'median levels of haptoglobin', 'Postoperative free hemoglobin levels', 'postoperative lactate dehydrogenase and bilirubin levels', 'postoperative free hemoglobin and haptoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}]",35.0,0.116076,Postoperative free hemoglobin levels were not significantly different between the groups.,"[{'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Bernardi', 'Affiliation': 'From the Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Rinoesl', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Landeskrankenhaus Feldkirch, Feldkirch, Austria.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ristl', 'Affiliation': 'Centre for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Weber', 'Affiliation': 'From the Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hiesmayr', 'Affiliation': 'From the Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}]",ASAIO journal (American Society for Artificial Internal Organs : 1992),['10.1097/MAT.0000000000000897'] 535,32220517,The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor.,"RESEARCH QUESTION Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis. DESIGN Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420). RESULTS No statistically significant difference in live birth rate was found between the control group and the Embryogen®/BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used. CONCLUSION A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.",2020,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","['couples undergoing IVF/ICSI', '100 couples undergoing IVF/ICSI', 'women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis']","['Embryogen®/BlastGen', 'having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media', 'blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor']","['blastulation rate', 'grade of the embryo transferred', 'live birth rates', 'live birth rate']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}]","[{'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0010454', 'cui_str': 'Culture Media'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",100.0,0.22946,"A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia. Electronic address: ryan.rose@adelaide.edu.au.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Barry', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Dunstan', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Siu Man', 'Initials': 'SM', 'LastName': 'Yuen', 'Affiliation': 'Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'Lyndal P', 'Initials': 'LP', 'LastName': 'Cameron', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Knight', 'Affiliation': 'School of Public Health, Robinson Research Institute, AHMS Building, The University of Adelaide, North Terrace, Adelaide5005 SA, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}, {'ForeName': 'M Louise', 'Initials': 'ML', 'LastName': 'Hull', 'Affiliation': 'Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.011'] 536,32220595,Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study.,"OBJECTIVE The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP). STUDY DESIGN Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test. RESULTS Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58). CONCLUSIONS Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.",2020,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"['oral lichen planus', 'Twenty-four patients (females n\xa0=\xa021; median age 64.5 years; range 45-80 years', 'Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater']","['Dexamethasone solution and dexamethasone', 'dexamethasone 0.1 mg/mL solution alone', 'dexamethasone', 'Dexamethasone']","['erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ', 'REU score', 'safety and efficacy', 'total COMDQ score']","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023643', 'cui_str': 'Lichen condition'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2746127', 'cui_str': 'Dexamethasone 0.1 MG/ML [Baycadron]'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0151785', 'cui_str': 'Disorder of mucous membrane'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.193386,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA. Electronic address: Avilla@partners.org.""}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Sankar', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Bassani', 'Affiliation': 'Professional Compounding Centers of America, Houston, TX, USA.'}, {'ForeName': 'Lisa Bennett', 'Initials': 'LB', 'LastName': 'Johnson', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Sroussi', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.02.014'] 537,32220893,Disease Monitoring Using Post-induction Circulating Tumor DNA Analysis Following First-Line Therapy in Patients with Metastatic Colorectal Cancer.,"PURPOSE We assessed plasma circulating tumor DNA (ctDNA) level as a prognostic marker for progression-free survival (PFS) following first-line metastatic colorectal cancer (mCRC) therapy. EXPERIMENTAL DESIGN The Sequencing Triplet With Avastin and Maintenance (STEAM) was a randomized, phase II trial investigating efficacy of bevacizumab (BEV) plus 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) and 5-fluorouracil/leucovorin/irinotecan (FOLFIRI), administered concurrently or sequentially, versus FOLFOX-BEV in first-line mCRC. Evaluation of biomarkers associated with treatment outcomes was an exploratory endpoint. Patients in the biomarker-evaluable population (BEP) had 1 tissue sample, 1 pre-induction plasma sample, and 1 post-induction plasma sample collected ≤60 days of induction from last drug date. RESULTS Among the 280 patients enrolled in STEAM, 183 had sequenced and evaluable tumor tissue, 118 had matched pre-induction plasma, and 54 (BEP) had ctDNA-evaluable sequencing data for pre- and post-induction plasma. The most common somatic variants in tumor tissue and pre-induction plasma were TP53, APC , and KRAS . Patients with lower-than-median versus higher-than-median post-induction mean allele fraction (mAF) levels had longer median PFS (17.7 vs. 7.5 months, HR, 0.33; 95% confidence interval, 0.17-0.63). Higher levels of post-induction mAF and post-induction mean mutant molecules per milliliter (mMMPM), and changes in ctDNA (stratified by a 10-fold or 100-fold reduction in mAF between pre- and post-induction plasma), were associated with shorter PFS. Post-induction mAF and mMMPM generally correlated with each other ( ρ = 0.987, P < 0.0001). CONCLUSIONS ctDNA quantification in post-induction plasma may serve as a prognostic biomarker for mCRC post-treatment outcomes.",2020,"Post-induction mAF and mMMPM generally correlated with each other ( r = 0.987, P < 0.0001). ","['280 patients enrolled in STEAM, 183 had sequenced and evaluable tumor tissue, 118 had matched pre-induction plasma, and 54 (BEP) had ctDNA-evaluable sequencing data for pre- and post-induction plasma', 'Patients in the biomarker evaluable population (BEP) had 1 tissue sample, 1 pre-induction plasma sample, and 1 post-induction plasma sample collected ≤60 days of induction from last drug date', 'Patients with Metastatic Colorectal Cancer']","['bevacizumab (BEV) plus 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX) and 5-fluorouracil/leucovorin/irinotecan (FOLFIRI', 'Disease Monitoring Using Post-Induction Circulating Tumor DNA Analysis Following First-Line Therapy']","['median PFS', 'Higher levels of post-induction mAF and post-induction mean mutant molecules per milliliter (mMMPM), and changes in ctDNA', 'plasma circulating tumor DNA (ctDNA) level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0079786', 'cui_str': 'Macrophage-Activating Factors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}]",280.0,0.0324867,"Post-induction mAF and mMMPM generally correlated with each other ( r = 0.987, P < 0.0001). ","[{'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Max Ma', 'Affiliation': 'Medical Scientific Affairs, Roche Sequencing Solutions, Inc., Pleasanton, California. xiaoju.ma@gmail.com john.palma@roche.com.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Drug Development Unit, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Herbert I', 'Initials': 'HI', 'LastName': 'Hurwitz', 'Affiliation': 'Project Development Oncology, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ju', 'Affiliation': 'Clinical Operations and Biometrics, Roche Molecular Systems, Pleasanton, California.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Medical Scientific Affairs, Roche Sequencing Solutions, Inc., Pleasanton, California.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Lovejoy', 'Affiliation': 'Assay Development, Roche Sequencing Solutions, Inc., Pleasanton, California.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mancao', 'Affiliation': 'Oncology Biomarker Development, Genentech, Inc., Basel, Switzerland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Nicholas', 'Affiliation': 'US Medical Affairs and Biometrics, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'Oncology Biomarker Development, Genentech, Inc., Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sommer', 'Affiliation': 'Medical Affairs BioOncology, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Nalin', 'Initials': 'N', 'LastName': 'Tikoo', 'Affiliation': 'Clinical Operations and Biometrics, Roche Molecular Systems, Pleasanton, California.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Bioinformatics Research and Early Development, Roche Sequencing Solutions, Inc., Pleasanton, California.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Yaung', 'Affiliation': 'Medical and Scientific Affairs Bioinformatics, Roche Sequencing Solutions, Inc., Pleasanton, California.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Palma', 'Affiliation': 'Medical Scientific Affairs, Roche Sequencing Solutions, Inc., Pleasanton, California. xiaoju.ma@gmail.com john.palma@roche.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1209'] 538,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. METHODS Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. RESULTS Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. CONCLUSIONS A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2 reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2 reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7'] 539,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8'] 540,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers. SUBJECTS/METHODS This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values. RESULTS After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). CONCLUSIONS Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). ","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). ","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4'] 541,32133780,Maternal cardiac function in women at high risk for pre-eclampsia treated with 150 mg aspirin or placebo: an observational study.,"OBJECTIVE To compare maternal haemodynamics in women at low and high risk for preterm pre-eclampsia (PE), and between those at high risk who are randomised to aspirin or placebo. DESIGN Prospective, longitudinal observational study. SETTING Maternity units in six UK hospitals. POPULATION Women participating in the Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial. The population comprised three groups of women: low risk for preterm PE (n = 1362), high risk for preterm PE treated with aspirin (n = 208) and high risk for preterm PE on placebo (n = 220). METHODS Women had four visits during pregnancy: 11-14, 19-24, 30-34, and 35-37 weeks' gestation. Blood pressure was measured with a device validated for pregnancy, and PE and maternal haemodynamics were assessed with a bioreactance monitor at each visit. A multilevel linear mixed-effects analysis was performed to examine longitudinal changes of maternal haemodynamic variables, controlling for demographic characteristics, past medical history and medication use. MAIN OUTCOME MEASURES Longitudinal changes of cardiac output (CO), mean arterial pressure (MAP), and peripheral vascular resistance (PVR). RESULTS The low-risk group demonstrated the expected changes with an increase in CO and reduction in MAP and PVR, with a quadratic change across gestation. In contrast, the high-risk groups had a declining CO, and higher MAP and PVR during pregnancy. The administration of aspirin did not appear to affect maternal haemodynamics. CONCLUSIONS Women screened as high risk for preterm PE have a pathological cardiac adaptation to pregnancy and the prophylactic use of aspirin (150 mg oral daily from the first trimester) in this group may not alter this haemodynamic profile. TWEETABLE ABSTRACT In women at high risk of pre-eclampsia, prophylactic use of aspirin may not alter the impaired maternal cardiac adaptation.",2020,"The administration of aspirin did not appear to affect maternal haemodynamics. ","['Women participating in the Aspirin for Prevention of Preterm Pre-eclampsia (ASPRE) trial', 'Maternity units in six UK hospitals', ""Women had four visits during pregnancy: 11-14, 19-24, 30-34- and 35-37 weeks' gestation"", 'women at high-risk for preeclampsia treated with 150mg', 'women low and high-risk for preterm pre-eclampsia (PE) and between those high-risk randomised to', 'population comprised of three groups of women: low-risk for preterm PE (N=1362), high-risk for preterm PE treated with aspirin (N=208), and high-risk for preterm PE on placebo (N=220']","['aspirin or placebo', 'aspirin', 'Aspirin or placebo']","['CO and reduction in MAP and PVR', 'Blood pressure', 'pregnancy and PE and maternal haemodynamics', 'Maternal cardiac function', 'maternal haemodynamics', 'cardiac output (CO), mean arterial pressure (MAP) and peripheral vascular resistance (PVR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",,0.607837,"The administration of aspirin did not appear to affect maternal haemodynamics. ","[{'ForeName': 'H Z', 'Initials': 'HZ', 'LastName': 'Ling', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Jara', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bisquera', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Poon', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Nicolaides', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Kametas', 'Affiliation': ""Fetal Medicine Research Institute, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16193'] 542,32220091,Improved quality of care by using the PRISMS form to support self-management in patients with COPD: A Randomised Controlled Trial.,"AIMS AND OBJECTIVE To investigate the effects on the quality of care of the Patient Report Informing Self-Management Support (PRISMS) form compared with usual care among patients with chronic obstructive pulmonary disease (COPD) consulting a COPD nurse in primary health care. BACKGROUND Patients with COPD experience symptoms affecting their everyday lives, and there is a need for interventions in self-management support. The delivery of chronic care in an organised, structured and planned manner can lead to more productive relationships between professionals and patients. DESIGN A multicentre randomised controlled trial with a post-test design, according to the CONSORT checklist, in one intervention group (n = 94) and one control group (n = 108). METHODS In addition to usual care, the intervention group (n = 94) completed the PRISMS form to indicate areas where they wanted self-management support before the consultation with the COPD nurse. This form comprises 17 items that patients with COPD commonly experience as problems. The control group received usual care (n = 108). The primary outcome was patients' satisfaction with quality of care, assessed using the Quality from the Patient's Perspective (QPP) questionnaire. Means and (SD) are presented where applicable. Differences between the intervention and control group were analysed with Student's t test for independent groups for interval data, and the Mann-Whitney U test for ordinal data. RESULTS Participants in the intervention group were more satisfied with the QPP domains ""personal attention,"" regarding both ""perceived reality"" (p = .021) and ""subjective importance"" (p = .012). The PRISMS form revealed ""shortness of breath"" as the most commonly experienced problem and the issue most desired to discuss. CONCLUSION The PRISMS form improved patient satisfaction with quality of care regarding personal attention, which is an important factor in patient participation and improving relationships and communication. RELEVANCE TO CLINICAL PRACTICE The PRISMS form can be a useful tool in improving person-centred care when delivering self-management support. REGISTER ID 192691 at http://www.researchweb.org/is/en/sverige/project/192691.",2020,"RESULTS Participants in the intervention group were more satisfied with the QPP domains ""personal attention"", regarding both ""Perceived reality"" (p=0.021) and ""Subjective Importance"" (p=0.012).","['patients with Chronic Obstructive Pulmonary Disease (COPD) consulting a COPD nurse in primary health care', 'Patients with COPD experience symptoms affecting their everyday lives', 'patients with COPD', 'patients with COPD commonly experience as problems']","['usual care', 'Self-Management Support (PRISMS']","['Improved quality of care', 'Subjective Importance', 'QPP domains ""personal attention"", regarding both ""Perceived reality', ""patients' satisfaction with quality of care, assessed using the Quality from the Patient's Perspective (QPP) questionnaire""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0766278,"RESULTS Participants in the intervention group were more satisfied with the QPP domains ""personal attention"", regarding both ""Perceived reality"" (p=0.021) and ""Subjective Importance"" (p=0.012).","[{'ForeName': 'Ann-Britt', 'Initials': 'AB', 'LastName': 'Zakrisson', 'Affiliation': 'Department of University Healthcare Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Arne', 'Affiliation': 'Centre for Clinical Research, RegionVärmland, Karlstad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lisspers', 'Affiliation': 'Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Lundh', 'Affiliation': 'NVS, Division of Family Medicine and Primary Care, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sandelowsky', 'Affiliation': 'NVS, Division of Family Medicine and Primary Care, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Ställberg', 'Affiliation': 'Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Thors Adolfsson', 'Affiliation': 'Primary Health Care, Region Västmanland, Västerås, Sweden.'}, {'ForeName': 'Kersti', 'Initials': 'K', 'LastName': 'Theander', 'Affiliation': 'Centre for Clinical Research, RegionVärmland, Karlstad, Sweden.'}]",Journal of clinical nursing,['10.1111/jocn.15253'] 543,32108181,Eating breakfast and avoiding late-evening snacking sustains lipid oxidation.,"Circadian (daily) regulation of metabolic pathways implies that food may be metabolized differentially over the daily cycle. To test that hypothesis, we monitored the metabolism of older subjects in a whole-room respiratory chamber over two separate 56-h sessions in a random crossover design. In one session, one of the 3 daily meals was presented as breakfast, whereas in the other session, a nutritionally equivalent meal was presented as a late-evening snack. The duration of the overnight fast was the same for both sessions. Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions. Unexpectedly, this difference in RER due to daily meal timing was not due to daily differences in physical activity, sleep disruption, or core body temperature (CBT). Rather, we found that the daily timing of nutrient availability coupled with daily/circadian control of metabolism drives a switch in substrate preference such that the late-evening Snack Session resulted in significantly lower lipid oxidation (LO) compared to the Breakfast Session. Therefore, the timing of meals during the day/night cycle affects how ingested food is oxidized or stored in humans, with important implications for optimal eating habits.",2020,"Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions.",[],['Eating breakfast and avoiding late-evening snacking sustains lipid oxidation'],"['overall energy expenditure, the respiratory exchange ratio (RER', 'physical activity, sleep disruption, or core body temperature (CBT', 'RER', 'duration of the overnight fast', 'lipid oxidation (LO']",[],"[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]",,0.0309961,"Whereas the two sessions did not differ in overall energy expenditure, the respiratory exchange ratio (RER) was different during sleep between the two sessions.","[{'ForeName': 'Kevin Parsons', 'Initials': 'KP', 'LastName': 'Kelly', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Owen P', 'Initials': 'OP', 'LastName': 'McGuinness', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Buchowski', 'Affiliation': 'Division of Gastroenterology, Hepatology, & Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Hughey', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Carl Hirschie', 'Initials': 'CH', 'LastName': 'Johnson', 'Affiliation': 'Department of Biological Sciences, Vanderbilt University, Nashville, Tennessee, United States of America.'}]",PLoS biology,['10.1371/journal.pbio.3000622'] 544,32219442,Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial.,"Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.",2020,"The CR/CRi rates were 48% and 13% for the Venetoclax plus LDAC arm and LDAC-alone arm, respectively.","['Patients (N=211', 'patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy', 'Median age was 76 years (range 36-93), 38% had secondary AML, and 20% had prior hypomethylating agent (HMA) treatment', 'Adults ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy', 'patients unfit for intensive chemotherapy', 'patients with untreated AML ineligible for intensive chemotherapy']","['venetoclax plus LDAC', 'placebo', 'placebo (N=68) in 28-day cycles, plus low-dose cytarabine (LDAC', 'venetoclax', 'Venetoclax plus LDAC']","['risk-of-death', 'overall survival (OS); secondary endpoints included response rates, transfusion independence, and event-free survival', 'CR/CRi rates', 'remission rates and OS', 'median OS', 'thrombocytopenia', 'febrile neutropenia', 'neutropenia', 'Key grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",211.0,0.633503,"The CR/CRi rates were 48% and 13% for the Venetoclax plus LDAC arm and LDAC-alone arm, respectively.","[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitario y Politecnico La Fe, Valencia, Spain.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Ivanov', 'Affiliation': 'Almazov National Medical Research Center, Saint Petersburg, Russia.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novak', 'Affiliation': 'Department of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Laribi', 'Affiliation': 'Centre Hospitalier Le Mans, Le Mans, France.'}, {'ForeName': 'Inho', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Stevens', 'Affiliation': 'Norton Cancer Institute, Louisville, KY.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pagoni', 'Affiliation': 'Evaggelismos General Hospital, Athens Greece.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoilova', 'Affiliation': 'Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'George Papanicolaou General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bergeron', 'Affiliation': ""Centre Intégré Universitaire de Santé et de Services Sociaux de l'Est-de-l'Île-de-Montréal (CIUSSSEMTL), Installation Maisonneuve-Rosemont, Montreal, QC, Canada.""}, {'ForeName': 'Jing-Zhou', 'Initials': 'JZ', 'LastName': 'Hou', 'Affiliation': 'University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.'}, {'ForeName': 'Vidhya', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Heartlands Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'University of Fukui Hospital, Fukui, Japan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Netcare Pretoria East Hospital, Pretoria, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chyla', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Sathej', 'Initials': 'S', 'LastName': 'Gopalakrishnan', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Wellington', 'Initials': 'W', 'LastName': 'Mendes', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hayslip', 'Affiliation': 'AbbVie, Inc., North Chicago, IL; and.'}, {'ForeName': 'Panayiotis', 'Initials': 'P', 'LastName': 'Panayiotidis', 'Affiliation': 'Laiko General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.'}]",Blood,['10.1182/blood.2020004856'] 545,32216964,Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial.,"BACKGROUND Excessive intraoperative hemorrhage is a critical factor of poor prognoses after hepatectomy. Low central venous pressure during parenchymal transection is recognized to effectively reduce intraoperative hemorrhage in open procedures. However, the role of controlled low central venous pressure in laparoscopic hepatectomy is still controversial. METHODS In the present randomized clinical trial, we set up a standard boundary of low central venous pressure according to our Pilot Study, then enrolled patients scheduled for elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group. The primary efficacy endpoint was total intraoperative blood loss and perioperative adverse events. Analyses were performed following the intention-to-treat principle, and patients and surgeons were blinded (ClinicalTrials.gov, Number: NCT03422913). RESULTS Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses. Based on the retrospective training cohort, we set a central venous pressure of 5 cm H 2 O as a cutoff value (standard low central venous pressure). Compared with patients in the control group, those in the controlled low central venous pressure group had a significantly lower central venous pressure during resection (4.83 ± 3.41 cm H 2 O vs 9.26 ± 3.38 cm H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001). The perioperative adverse events were comparable in both study groups (P = .313). CONCLUSION The safety and efficacy of controlled low central venous pressure were demonstrated in complex laparoscopic hepatectomy for the first time by our study, and this technique is recommended to be applied routinely in laparoscopic hepatectomy.",2020,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"['Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses']","['laparoscopic hepatectomy', 'elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group', 'control low central venous pressure']","['total intraoperative blood loss and perioperative adverse events', 'perioperative adverse events', 'intraoperative hemorrhage', 'central venous pressure', 'blood loss', 'total intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}]",469.0,0.0917269,H 2 O; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001).,"[{'ForeName': 'Yang-Xun', 'Initials': 'YX', 'LastName': 'Pan', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jun-Cheng', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jin-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Jian-Cong', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yi-Zhen', 'Initials': 'YZ', 'LastName': 'Fu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Min-Shan', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.'}, {'ForeName': 'Ren-Chun', 'Initials': 'RC', 'LastName': 'Lai', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: lairch@sysucc.org.cn.'}, {'ForeName': 'Zhong-Guo', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China. Electronic address: zhouzhg@sysucc.org.cn.'}]",Surgery,['10.1016/j.surg.2020.02.004'] 546,31407653,Five-Year Impact of Different Multi-Year Mass Drug Administration Strategies on Childhood Schistosoma mansoni -Associated Morbidity: A Combined Analysis from the Schistosomiasis Consortium for Operational Research and Evaluation Cohort Studies in the Lake Victoria Regions of Kenya and Tanzania.,"The WHO recommends mass treatment with praziquantel as the primary approach for Schistosoma mansoni -related morbidity control in endemic populations. The Schistosomiasis Consortium for Operational Research and Evaluation implemented multi-country, cluster-randomized trials to compare effectiveness of community-wide and school-based treatment (SBT) regimens on prevalence and intensity of schistosomiasis. To assess the impact of two different treatment schedules on S. mansoni -associated morbidity in children, cohort studies were nested within the randomized trials conducted in villages in Kenya and Tanzania having baseline prevalence ≥ 25%. Children aged 7-8 years were enrolled at baseline and followed to ages 11-12 years. Infection intensity and odds of infection were reduced both in villages receiving four years of annual community-wide treatment (CWT) and those who received biennial SBT over 4 years. These regimens were also associated with reduced odds of undernutrition and reduced odds of portal vein dilation at follow-up. However, neither hemoglobin levels nor the prevalence of the rare abnormal pattern C liver scores on ultrasound improved. For the combined cohorts, growth stunting worsened in the areas receiving biennial SBT, and maximal oxygen uptake as estimated by fitness testing scores declined under both regimens. After adjusting for imbalance in starting prevalence between study arms, children in villages receiving annual CWT had significantly greater decreases in infection prevalence and intensity than those villages receiving biennial SBT. Although health-related quality-of-life scores improved in both study arms, children in the CWT villages gained significantly more. We conclude that programs using annual CWT are likely to achieve better overall S. mansoni morbidity control than those implementing only biennial SBT.",2019,Infection intensity and odds of infection were reduced both in villages receiving four years of annual community-wide treatment (CWT) and those who received biennial SBT over 4 years.,"['Children aged 7-8 years were enrolled at baseline and followed to ages 11-12 years', 'children, cohort studies were nested within the randomized trials conducted in villages in Kenya and Tanzania having baseline prevalence ≥ 25', 'Childhood Schistosoma mansoni -Associated']","['praziquantel', 'community-wide and school-based treatment (SBT) regimens', 'biennial SBT']","['prevalence and intensity of schistosomiasis', 'health-related quality-of-life scores', 'Morbidity', 'maximal oxygen uptake', 'reduced odds of undernutrition and reduced odds of portal vein dilation', 'infection prevalence and intensity', 'Infection intensity and odds of infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0662164,Infection intensity and odds of infection were reduced both in villages receiving four years of annual community-wide treatment (CWT) and those who received biennial SBT over 4 years.,"[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Section for Parasitology and Aquatic Pathobiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'King', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kittur', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Binder', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Whalen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of Georgia, Athens, Georgia.'}, {'ForeName': 'William Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Parasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Montgomery', 'Affiliation': 'Parasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Pauline N M', 'Initials': 'PNM', 'LastName': 'Mwinzi', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Magnussen', 'Affiliation': 'Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'Mwanza Research Centre, National Institute for Medical Research, Mwanza, Tanzania.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Campbell', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Colley', 'Affiliation': 'Department of Microbiology, University of Georgia, Athens, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0273'] 547,32217112,Radiofrequency ablation for low-grade dysplasia in Barrett's esophagus: long-term outcome of a randomized trial.,"BACKGROUND AND AIMS A prior randomized study (Surveillance versus Radiofrequency Ablation study [SURF study]) demonstrated that radiofrequency ablation (RFA) of Barrett's esophagus (BE) with confirmed low-grade dysplasia (LGD) significantly reduces the risk of esophageal adenocarcinoma. Our aim was to report the long-term outcomes of this study. METHODS The SURF study randomized BE patients with confirmed LGD to RFA or surveillance. For this retrospective cohort study, all endoscopic and histologic data acquired at the end of the SURF study in May 2013 until December 2017 were collected. The primary outcome was rate of progression to high-grade dysplasia (HGD)/cancer. All 136 patients randomized to RFA (n = 68) or surveillance (n = 68) in the SURF study were included. After closure of the SURF study, 15 surveillance patients underwent RFA based on patient preference and study outcomes. RESULTS With 40 additional months (interquartile range, 12-51), the total median follow-up from randomization to last endoscopy was 73 months (interquartile range, 46-85). HGD/cancer was diagnosed in 1 patient in the RFA group (1.5%) and in 23 in the surveillance group (33.8%) (P = .000), resulting in an absolute risk reduction of 32.4% (95% confidence interval [CI], 22.4%-44.2%) with a number needed to treat of 3.1 (95% CI, 2.3-4.5). Seventy-five of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia. BE recurred in 7 of 75 patients (9%; 95% CI, 4.6%-18.0%), mostly minute islands or tongues, and LGD in 3 of 75 (4%; 95% CI, 1.4%-11.1%). CONCLUSIONS RFA of BE with confirmed LGD significantly reduces the risk of malignant progression, with sustained clearance of BE in 91% and LGD in 96% of patients, after a median follow-up of 73 months. (Clinical trial registration number: NTR1198.).",2020,"Seventy-five out of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia.","['all endoscopic and histological data acquired after end of the SURF study in May 2013 until December 2017 were collected', ""low-grade dysplasia in Barrett's esophagus"", '15 surveillance patients underwent', 'All 136 patients randomized to RFA (n=68) or surveillance (n=68) in the SURF study were included']","['Radiofrequency ablation', 'RFA', 'radiofrequency ablation (RFA']","['complete clearance of BE and dysplasia', 'rate of progression to HGD/cancer', 'HGD/cancer', 'BE', 'risk of malignant progression', 'absolute risk reduction']","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0336932', 'cui_str': 'Surfing'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0004763', 'cui_str': 'Barrett Metaplasia'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",15.0,0.172758,"Seventy-five out of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia.","[{'ForeName': 'Roos E', 'Initials': 'RE', 'LastName': 'Pouw', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Klaver', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'K Nadine', 'Initials': 'KN', 'LastName': 'Phoa', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Frederike G', 'Initials': 'FG', 'LastName': 'van Vilsteren', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas L', 'Initials': 'BL', 'LastName': 'Weusten', 'Affiliation': 'Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Raf', 'Initials': 'R', 'LastName': 'Bisschops', 'Affiliation': 'Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Schoon', 'Affiliation': 'Department of Gastroenterology, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pech', 'Affiliation': 'Department of Gastroenterology, Helios dr. Horst Schmidt Clinics Wiesbaden, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Manner', 'Affiliation': 'Department of Gastroenterology, Frankfurt Hoechst Hospital, Frankfurt, Germany.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Ragunath', 'Affiliation': 'Department of Gastroenterology, Queens Medical Center, Nottingham, UK.'}, {'ForeName': 'Jacobo Ortiz', 'Initials': 'JO', 'LastName': 'Fernández-Sordo', 'Affiliation': 'Department of Gastroenterology, Queens Medical Center, Nottingham, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Fullarton', 'Affiliation': 'Department of Surgical Gastroenterology, Glasgow Royal Infirmary, Glasgow, Scotland.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Di Pietro', 'Affiliation': 'Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Wladyslaw', 'Initials': 'W', 'LastName': 'Januszewicz', 'Affiliation': 'Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': ""O'Toole"", 'Affiliation': ""Department of Clinical Medicine and Gastroenterology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Jacques J', 'Initials': 'JJ', 'LastName': 'Bergman', 'Affiliation': 'Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.03.3756'] 548,32149451,"Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).","OBJECTIVES Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED). METHODS This exploratory, phase II, multicenter, randomized, double-blind, placebo-controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10-hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK + ) from baseline until 4 hours after start of dosing. RESULTS Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK + was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK + change from baseline to 4 hours was -0.41 (±0.11) mmol/L and -0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = -0.13 mmol/L, 95% confidence interval [CI] = -0.44 to 0.17). A greater reduction in mean (±SD) sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (±0.12) versus -0.36 (±0.11) mmol/L (LSM difference = -0.35 mmol/L, 95% CI = -0.68 to -0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium-lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours. CONCLUSIONS This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.",2020,A greater reduction in mean sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"['enrolled adult ED patients with blood potassium', '70 patients were randomized (SZC n = 33; placebo n = 37), of which 50.0% were male']","['SZC 10 g or placebo', 'Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate', 'SZC with insulin and glucose', 'placebo', 'Sodium zirconium cyclosilicate (SZC', 'SZC and placebo', 'Placebo']","['adverse events', 'additional potassium-lowering therapy due to hyperkalemia', 'mean change in serum potassium (sK + ', 'mean sK ', 'least squares mean (SD) sK + change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853173', 'cui_str': 'Blood potassium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",70.0,0.712986,A greater reduction in mean sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"[{'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Zubaid', 'Initials': 'Z', 'LastName': 'Rafique', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'the, First Pavlov State, Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Michelson', 'Affiliation': 'the, Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vishneva', 'Affiliation': ""the, Scientific Centre of Children's Health, Russian Academy of Medical Science, Moscow, Russia.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zvereva', 'Affiliation': 'the, Scientific Research Institution for Complex Issues of Cardiovascular Disease, Kemerovo Medical University, Kemerovo, Russia.'}, {'ForeName': 'Rajaa', 'Initials': 'R', 'LastName': 'Nahra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Dao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'and the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13954'] 549,32218418,Relation between redox homeostasis blood parameters in cirrhotic patients and endothelial dysfunction development.,"BACKGROUND Liver is one of the first organs to be exposed to reactive oxygen species (ROS). But the data about the levels of redox homeostasis parameters in the patients with liver cirrhosis (LC) are contradictory. We hypothesized that the levels of malondialdehyde and catalase should change in accordance with the LC severity causing the endothelial dysfunction. METHODS In a randomized way with the preliminary stratification by the presence of LC 81 patients and 20 healthy volunteers were examined. To determine the contents of catalase, malondialdehyde, cyclic guanosine monophosphate, endothelin-1, renin, aldosterone, natriuretic peptide, the routine standardized methods were used. RESULTS Patients with LC revealed the statistically significant increase of malondialdehyde and decrease of catalase levels in parallel with the increase of cyclic guanosine monophosphate, endothelin-1, renin, aldosterone, natriuretic peptide contents and disease course worsening according to the Child-Pugh criteria. It testifies the huge oxidative stress impact on the organism. Initially, at the stage of LC compensation, it slightly stimulates the activation of antioxidant system, followed by its gradual suppression at the stages of sub- and decompensation. Disorders of redox homeostasis lead to the endothelial dysfunction that becomes the background of extrahepatic comorbid disorders. CONCLUSIONS Cirrhotic patients have significant abnormalities in the redox homeostasis, which become the background of the endothelial dysfunction - common trigger mechanism for the syntrophic comorbid diseases and early pathophysiologic symptom of the unfavorable prognosis for such patients.",2020,"RESULTS Patients with LC revealed the statistically significant increase of malondialdehide and decrease of catalase levels in parallel with the increase of cyclic guanosine monophosphate, endothelin-1, renin, aldosterone, natriuretic peptide contents and disease course worsening according to C. H. Child-R. N. Pugh criteria.","['81 patients and 20 healthy volunteers', 'patients with liver cirrhosis (LC', 'patients with liver cirrhosis']",['LC'],"['redox homeostasis parameters', 'cyclic guanosine monophosphate, endothelin-1, renin, aldosterone, natriuretic peptide contents and disease course worsening', 'malondialdehide and decrease of catalase levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}]",[],"[{'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018338', 'cui_str': ""Guanosine Cyclic 3',5'-Monophosphate""}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",81.0,0.0176988,"RESULTS Patients with LC revealed the statistically significant increase of malondialdehide and decrease of catalase levels in parallel with the increase of cyclic guanosine monophosphate, endothelin-1, renin, aldosterone, natriuretic peptide contents and disease course worsening according to C. H. Child-R. N. Pugh criteria.","[{'ForeName': 'Maryana', 'Initials': 'M', 'LastName': 'Abrahamovych', 'Affiliation': 'Department of Family Medicine, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Orest', 'Initials': 'O', 'LastName': 'Abrahamovych', 'Affiliation': 'Department of Internal Medicine N. 1, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Fayura', 'Affiliation': 'Department of Internal Medicine N. 1, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine - fayurchuk@ukr.net.'}, {'ForeName': 'Solomiya', 'Initials': 'S', 'LastName': 'Tolopko', 'Affiliation': 'Department of Internal Medicine N. 1, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.'}]",Minerva gastroenterologica e dietologica,['10.23736/S1121-421X.20.02654-9'] 550,31595867,"Spatial Effects of Permethrin-Impregnated Bed Nets on Child Mortality: 26 Years on, a Spatial Reanalysis of a Cluster Randomized Trial.","In addition to the direct effect of insecticide-treated nets (ITNs), there has been evidence for spatial indirect effects. Spatial analyses in cluster randomized trials (CRTs) are rare, but a large-scale CRT from 1993 was one of the first to conduct a spatial analysis of ITNs in CRTs. We revisit these data by applying a broader range of contemporary spatial methods to further explore spatial spillover. We conducted three analyses: 1) exploratory spatial analysis, considering spatial patterns and spillover in the data; 2) spatial modeling, estimating the intervention effect considering spatial effects; and 3) analysis of distance-based spillover and interaction with the intervention, characterizing the functional distance over which the spillover effect was present. There were consistent indications of spatial patterns from the exploratory analysis. Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data. There was strong evidence of a spatial spillover effect: for every additional 100 m that a control household was from an intervention household (and vice versa), the standardized mortality ratio (SMR) increased by 1.7% (SMR 1.017, 95% credible interval 1.006-1.026). Despite evidence of a spatial spillover effect, the conclusions of the trial remain unaffected by spatial model specifications. Use of ITNs was clearly beneficial for individuals, and there was compelling evidence that they provide an indirect benefit to individuals living nearby. This article demonstrates the extra utility that spatial methods can provide when analyzing a CRT.",2019,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.",[],"['Permethrin-Impregnated Bed Nets', 'insecticide-treated nets (ITNs']","['standardized mortality ratio (SMR', 'Child Mortality']",[],"[{'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021576', 'cui_str': 'Insecticides'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0008083', 'cui_str': 'Child Mortality'}]",,0.184522,"Bed nets were associated with a 17% reduction in all-cause mortality for children aged 6-59 months, and the intervention estimate remained robust when allowing for the spatial structure of the data.","[{'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jarvis', 'Affiliation': 'MRC London Hub for Trials Methodology Research, London, United Kingdom.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Multerer', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Binka', 'Affiliation': 'School of Public Health, University of Health and Allied Sciences, Ho, Ghana.'}, {'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Edmunds', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Smith', 'Affiliation': 'University of Basel, Basel, Switzerland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0111'] 551,31998111,Effects of Transcranial Direct Current Stimulation Paired With Cognitive Training on Functional Connectivity of the Working Memory Network in Older Adults.,"Background Working memory, a fundamental short-term cognitive process, is known to decline with advanced age even in healthy older adults. Normal age-related declines in working memory can cause loss of independence and decreased quality of life. Cognitive training has shown some potential at enhancing certain cognitive processes, although, enhancements are variable. Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, has shown promise at enhancing working memory abilities, and may further the benefits from cognitive training interventions. However, the neural mechanisms underlying tDCS brain-based enhancements remain unknown. Objective/Hypothesis Assess the effects of a 2-week intervention of active-tDCS vs. sham paired with cognitive training on functional connectivity of the working memory network during an N-Back working memory task. Methods Healthy older adults ( N = 28; mean age = 74 ± 7.3) completed 10-sessions of cognitive training paired with active or sham-tDCS. Functional connectivity was evaluated at baseline and post-intervention during an N-Back task (2-Back vs. 0-Back). Results Active-tDCS vs. sham demonstrated a significant increase in connectivity between the left dorsolateral prefrontal cortex and right inferior parietal lobule at post-intervention during 2-Back. Target accuracy on 2-Back was significantly improved for active vs. sham at post-intervention. Conclusion These results suggest pairing tDCS with cognitive training enhances functional connectivity and working memory performance in older adults, and thus may hold promise as a method for remediating age-related cognitive decline. Future studies evaluating optimal dose and long-term effects of tDCS on brain function will help to maximize potential clinical impacts of tDCS paired with cognitive training in older adults. Clinical Trial Registration www.ClinicalTrials.gov, identifier NCT02137122.",2019,Active-tDCS vs. sham demonstrated a significant increase in connectivity between the left dorsolateral prefrontal cortex and right inferior parietal lobule at post-intervention during 2-Back.,"['Healthy older adults ( N = 28; mean age = 74 ± 7.3) completed 10-sessions of', 'Older Adults', 'older adults', 'healthy older adults']","['tDCS', 'Transcranial Direct Current Stimulation Paired With Cognitive Training', 'Transcranial direct current stimulation (tDCS', 'cognitive training paired with active or sham-tDCS', 'cognitive training', 'Cognitive training', 'active-tDCS vs. sham paired with cognitive training']","['Functional Connectivity of the Working Memory Network', 'quality of life', 'connectivity', 'Target accuracy on 2-Back', 'Functional connectivity', 'functional connectivity and working memory performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034380'}]",,0.10366,Active-tDCS vs. sham demonstrated a significant increase in connectivity between the left dorsolateral prefrontal cortex and right inferior parietal lobule at post-intervention during 2-Back.,"[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Nissim', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': ""O'Shea"", 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Aprinda', 'Initials': 'A', 'LastName': 'Indahlastari', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Kraft', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'von Mering', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Aksu', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Porges', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Center for Cognitive Aging and Memory, Department of Clinical and Health Psychology, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2019.00340'] 552,31171092,Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer.,"BACKGROUND Trastuzumab is highly effective for human epidermal growth factor receptor type 2 (HER2)-positive breast cancer but is associated with a decline in left ventricular ejection fraction. OBJECTIVES The purpose of this study was to determine whether angiotensin-converting enzyme inhibitors or beta-blockers reduce the rate of trastuzumab-induced cardiotoxicity (left ventricular ejection fraction decrease >10%, or >5% if below 50%) and limit treatment interruptions. METHODS In this double-blind, multicenter, placebo-controlled trial, cardiotoxicity and treatment interruptions in patients with HER2-positive breast cancer treated with trastuzumab for 12 months were evaluated over a 2-year period. Patients were stratified by anthracycline use and then randomized to receive lisinopril, carvedilol, or placebo. RESULTS The study included 468 women, age 51 ± 10.7 years. For the entire cohort, cardiotoxicity was comparable in the 3 arms and occurred in 32% of patients on placebo, 29% on carvedilol, and 30% on lisinopril. For patients receiving anthracyclines, the event rates were higher in the placebo group (47%) than in the lisinopril (37%) and the carvedilol (31%) groups. Cardiotoxicity-free survival was longer on both carvedilol (hazard ratio: 0.49; 95% confidence interval: 0.27 to 0.89; p = 0.009) and lisinopril (hazard ratio: 0.53; 95% confidence interval: 0.30 to 0.94; p = 0.015) than on placebo. In the whole cohort, as well as in the anthracycline arm, patients on active therapy with either angiotensin-converting enzyme inhibitor or beta-blockers experienced fewer interruptions in trastuzumab than those on placebo. CONCLUSIONS In patients with HER2-positive breast cancer treated with trastuzumab, both lisinopril and carvedilol prevented cardiotoxicity in patients receiving anthracyclines. For such patients, lisinopril or carvedilol should be considered to minimize interruptions of trastuzumab. (Lisinopril or Coreg CR in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab; NCT01009918).",2019,"For the entire cohort, cardiotoxicity was comparable in the 3 arms and occurred in 32% of patients on placebo, 29% on carvedilol, and 30% on lisinopril.","['patients with HER2-positive breast cancer treated with', 'Patients', '468 women, age 51 ± 10.7 years', 'Women With Breast Cancer Receiving', 'patients with HER2-positive breast cancer treated with trastuzumab for 12\xa0months']","['lisinopril', 'placebo', 'Trastuzumab', 'lisinopril, carvedilol, or placebo', 'lisinopril or carvedilol', 'trastuzumab, both lisinopril and carvedilol', 'anthracyclines', 'Lisinopril or Coreg CR', 'angiotensin-converting enzyme inhibitor or beta-blockers', 'Lisinopril Versus', 'angiotensin-converting enzyme inhibitors or beta-blockers', 'carvedilol', 'Carvedilol']","['rate of trastuzumab-induced cardiotoxicity (left ventricular ejection fraction', 'cardiotoxicity', 'event rates', 'Cardiotoxicity-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0719509', 'cui_str': 'Coreg'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",468.0,0.150428,"For the entire cohort, cardiotoxicity was comparable in the 3 arms and occurred in 32% of patients on placebo, 29% on carvedilol, and 30% on lisinopril.","[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Guglin', 'Affiliation': 'University of Kentucky, Gill Heart & Vascular Institute, Lexington, Kentucky. Electronic address: maya.guglin@uky.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Krischer', 'Affiliation': 'University of South Florida, Health Informatics Institute, Tampa, Florida.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Tamura', 'Affiliation': 'University of South Florida, Health Informatics Institute, Tampa, Florida.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bello-Matricaria', 'Affiliation': 'University of South Florida, Health Informatics Institute, Tampa, Florida.'}, {'ForeName': 'Worta', 'Initials': 'W', 'LastName': 'McCaskill-Stevens', 'Affiliation': 'National Cancer Institute, Community Oncology and Prevention Trials Research Group, Rockville, Maryland.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.03.495'] 553,30882234,Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients.,"BACKGROUND Patients with end-stage renal disease who are undergoing dialysis are reported to be at high risk of sudden cardiac death (SCD), and to date, no therapy has been shown to be effective in reducing this risk. The feasibility and value of prophylactic implantable cardioverter-defibrillator (ICD) implantation to prevent SCD is uncertain. METHODS We conducted the ICD2 trial (Implantable Cardioverter-Defibrillator in Dialysis Patients), a prospective, randomized, controlled study investigating the value and safety of ICD implantation to prevent SCD in 200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments. The primary end point was SCD. Secondary end points were all-cause mortality and ICD-related complications. RESULTS The trial was stopped as per the recommendation of the data and safety monitoring board for futility reasons after inclusion of 188 patients, 97 in the ICD group and 91 in the control group. The median duration of follow-up was 6.8 years (interquartile range, 3.8-8.8 years). SCD occurred in 19 of 188 cases (10.1%), 11 of 97 in the ICD group and 8 of 91 in the control group. The cumulative SCD incidence at 5 years was 9.7% (95% CI, 3.3%-16.2%) in the ICD group and 7.9% (95% CI, 1.7-14.0%) in the control group, resulting in a hazard ratio of 1.32 (95% CI, 0.53-3.29; P=0.55). Overall, 99 of 188 patients died (52.7%), 52 in the ICD group and 47 in the control group. Five-year survival probability was 50.6% (95% CI, 39.8%-61.5%) in the ICD group and 54.5% (95% CI, 43.0-66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69-1.52; P=0.92). Among 80 patients who received an ICD, 25 adverse events related to ICD implantation occurred. CONCLUSIONS In a well-screened and well-treated population undergoing dialysis, prophylactic ICD therapy did not reduce the rate of SCD or all-cause mortality, which remained high. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com . Unique identifier: ISRCTN20479861.",2019,"Five-year survival probability was 50.6% (95% CI, 39.8%-61.5%) in the ICD group and 54.5% (95% CI, 43.0-66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69-1.52; P=0.92).","['Patients with end-stage renal disease who are undergoing dialysis', '188 patients, 97 in the ICD group and 91 in the control group', '200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments', 'Dialysis Patients', '80 patients who received an ICD, 25 adverse events related to ICD implantation occurred']","['ICD implantation', 'Implantable Cardioverter-Defibrillators', 'prophylactic implantable cardioverter-defibrillator (ICD) implantation', 'ICD2 trial (Implantable Cardioverter-Defibrillator']","['cause mortality and ICD-related complications', 'Five-year survival probability', 'rate of SCD or all-cause mortality', 'SCD', 'cumulative SCD incidence', 'median duration of follow']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",200.0,0.161018,"Five-year survival probability was 50.6% (95% CI, 39.8%-61.5%) in the ICD group and 54.5% (95% CI, 43.0-66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69-1.52; P=0.92).","[{'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine (J.I.R., T.J.R.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Liselotte C R', 'Initials': 'LCR', 'LastName': 'Hensen', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Maurits S', 'Initials': 'MS', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Mihaly K', 'Initials': 'MK', 'LastName': 'de Bie', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences (H.P.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Medical Statistics, Academic Medical Center, Amsterdam, The Netherlands (A.H.Z.).'}, {'ForeName': 'Lieselot', 'Initials': 'L', 'LastName': 'van Erven', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'M Jacqueline', 'Initials': 'MJ', 'LastName': 'Krol-van Straaten', 'Affiliation': 'Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands (M.J.K.v.S.).'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Hommes', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum, The Hague, The Netherlands (N.H.).'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Gabreëls', 'Affiliation': 'Department of Internal Medicine, Alrijne Ziekenhuis, Leiderdorp, The Netherlands (B.G.).'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'van Dorp', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Haarlem, The Netherlands (W.v.D.).'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'van Dam', 'Affiliation': 'Department of Internal Medicine, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands (B.v.D.).'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': 'Department of Internal Medicine, Hennepin County Medical Center, University of Minnesota, Minneapolis (C.A.H.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Schalij', 'Affiliation': 'Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine (J.I.R., T.J.R.), Leiden University Medical Center, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.039818'] 554,31194247,Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial.,"Importance Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC. Objective To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC. Design, Setting, and Participants This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population. Interventions Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal. Main Outcomes and Measures The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life. Results A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group). Conclusions and Relevance This study's findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended. Trial Registration ClinicalTrials.gov identifier: NCT01345669.",2019,"Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48).","['A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6', 'Squamous Cell Carcinoma of the Head and Neck', 'Importance\n\n\nLocoregionally advanced head and neck squamous cell cancer (HNSCC', '617 patients from November 2, 2011, to July 4, 2016', 'Patients who had complete response after CRT, comprising', ' with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study', 'patients with HNSCC']","['radiotherapy with cisplatin or carboplatin', 'Afatinib vs Placebo', 'placebo', 'Chemoradiotherapy', 'placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1', 'afatinib therapy after definitive chemoradiotherapy (CRT', 'afatinib']","['stomatitis', 'unacceptable adverse events, or patient withdrawal', 'Median DFS', 'tumor recurrence or secondary primary tumor or death', 'DFS', 'adverse events', 'acneiform rash', 'DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life', 'disease-free survival (DFS', 'diarrhea']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0020629', 'cui_str': 'Laryngopharynx'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",617.0,0.572963,"Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48).","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Department of Medicine and Yale Cancer Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Dinis', 'Affiliation': 'Instituto Português de Oncologia, Porto, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Trigo', 'Affiliation': 'Department of Medical Oncology, Hospital Virgen de la Victoria, IBIMA, Malaga, Spain.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Yokota', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Centre, Shizuoka, Japan.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza Viana', 'Affiliation': 'Department of Medical Oncology, Hospital Marcio Cunha, Ipatinga, Brazil.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Romanov', 'Affiliation': 'Russian Oncological Research Centre, Moscow, Russia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head and Neck Medical Oncology, National Cancer Centre Hospital East, Kashiwa, Japan.'}, {'ForeName': 'José Getulio', 'Initials': 'JG', 'LastName': 'Martins Segalla', 'Affiliation': 'Department of Clinical Oncology, Hospital Amaral Carvalho, Jau, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'Department of Internal Medicine, National Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Vasilevskaya', 'Affiliation': 'Oncology Centre of Moskovskiy, St Petersburg, Russia.'}, {'ForeName': 'Chaitali Singh', 'Initials': 'CS', 'LastName': 'Nangia', 'Affiliation': 'Comprehensive Cancer Centre, University of California at Irvine, Orange.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Chaves-Conde', 'Affiliation': 'Department of Oncology, Hospital Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Department of Medical Oncology and Hematology, Kobe University Hospital Cancer Center, Kobe, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Homma', 'Affiliation': 'Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Holeckova', 'Affiliation': 'Department of Oncology and Radiotherapy, Hospital Na Bulovce and 1st Medical Faculty of Charles University, Prague, Czech Republic.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Department of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Asarawala', 'Affiliation': 'Shree Krishna Hospital and Medical Research Centre, Gujarat, India.'}, {'ForeName': 'Ulisses Ribaldo', 'Initials': 'UR', 'LastName': 'Nicolau', 'Affiliation': 'Department of Clinical Oncology, AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rauch', 'Affiliation': 'Inselspital, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Department of Head and Neck Cancer, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Bushi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ehrnrooth', 'Affiliation': 'Boehringer Ingelheim, Danmark A/S, Denmark.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Division of Radiotherapy and Imaging, The Royal Marsden Hospital/The Institute of Cancer Research, National Institute for Health Research Biomedical Research Centre, London, United Kingdom.'}, {'ForeName': 'Ezra E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'Department of Translational Science, Moores Cancer Centre, University of California at San Diego, La Jolla.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2019.1146'] 555,31164368,"Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol.","INTRODUCTION Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes. METHODS AND ANALYSIS The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2-3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9-10 mmol/L, 70-180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated. ETHICS AND DISSEMINATION Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations. TRIAL REGISTRATION NUMBER NCT02925299; Pre-results.",2019,"Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed.","['Participants (n=130) are children and adolescents (aged ≥6\u2009and <19 years) with type 1 diabetes for at least 1\u2009year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58\u2009mmol/mol (7.5%) and ≤86\u2009mmol/mol (10', 'children and adolescents with type 1 diabetes']","['6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy', 'hybrid closed-loop insulin delivery, or to usual care', '6-month day-and-night automated closed-loop insulin delivery under free-living conditions', 'insulin pump therapy']","['SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels', 'time in the target glucose range', 'glycated haemoglobin', 'time with glucose levels', 'total, basal and bolus insulin dose, body mass index z-score and blood pressure', 'Cognitive, emotional and behavioural characteristics', 'efficacy, safety and utility', 'mean sensor glucose and time spent above and below target']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.168766,"Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Musolino', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Department of Diabetes and Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': ""Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Denvir', 'Affiliation': 'Department of Paediatric Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Trevelyan', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetes, Southampton Children's Hospital, Southampton General Hospital, Southampton, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, Colorado, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'DiMeglio', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology and Diabetology, Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Division of Pediatric Endocrinology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Division of Pediatric Endocrinology, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fox', 'Affiliation': 'Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borgman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Peiyao', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027856'] 556,32211907,Prevention of Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery: The PROMISE Trial.,"BACKGROUND AND OBJECTIVE To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema (ME) following cataract surgery. PATIENTS AND METHODS This phase 2, prospective, interventional, single-masked, randomized trial at a single academic center included 30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main outcome measures included treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities as detected by optical coherence tomography at any follow-up visit), a 30% or greater increase from preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters from Day 7 due to retinal thickening. RESULTS There were similar incidences of AEs between the two groups and no clinically serious ocular AEs in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161). Compared to the study group, the control group had a significantly greater increase in central subfield thickness (CST) at Day 30 (50.05 μm vs. 7.95 μm; P = .040) and Day 60 (56.45 μm vs. 3.02 μm; P = .010). However, the difference in CST between groups was no longer significant at Day 90 (50.31 μm vs. 18.48 μm; P = .12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 8.52; P = .66). CONCLUSIONS Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant AEs. Although there were significant differences in ME incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of VA. Further larger trials are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:170-178.].",2020,"The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161).","['30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification', 'Patients With Diabetic Retinopathy Undergoing Cataract Surgery', 'patients with diabetic retinopathy (DR']","['intravitreal aflibercept', 'intravitreal aflibercept injection (IAI']","['treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities', 'ME incidence and retinal thickness', 'preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters', 'safety and efficacy', 'BCVA gains', 'central subfield thickness (CST', 'ME events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.121642,"The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161).","[{'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Thais F', 'Initials': 'TF', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gans', 'Affiliation': ''}, {'ForeName': 'Felipe F', 'Initials': 'FF', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'Fabiana Q', 'Initials': 'FQ', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': ''}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200228-06'] 557,32211908,Functional and Morphologic Findings at Four Years After Intravitreal Bevacizumab or Laser for Type 1 ROP.,"BACKGROUND AND OBJECTIVE To compare morphologic and functional status at age 4 years for patients treated in one eye with laser photocoagulation and the other eye with intravitreal bevacizumab (IVB) injection for Type 1 retinopathy of prematurity (ROP). PATIENTS AND METHODS In this single-center, randomized, controlled trial, best-corrected visual acuity (BCVA) in logMAR was obtained along with spherical equivalent refraction (SER), fluorescein angiography (FA), optical coherent tomography (OCT), and OCT angiography (OCTA). RESULTS Eighteen babies (36 eyes) were selected for this study. BCVA and SER were similar in the two groups, but six patients had anisometropia of 4 diopters or more. IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference: -5.33 pixels; 95% confidence interval, -9.62 to -1.05). CONCLUSION Although the differences found here are minimal between the IVB-treated and laser-treated groups, further long-term evaluation of not only FA, but also OCT and OCTA, are needed in larger studies. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:180-186.].",2020,IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference:,['Eighteen babies (36 eyes'],"['Intravitreal Bevacizumab', 'BCVA', 'laser photocoagulation and the other eye with intravitreal bevacizumab (IVB) injection']","['spherical equivalent refraction (SER), fluorescein angiography (FA), optical coherent tomography (OCT), and OCT angiography (OCTA', 'thinner foveal thickness']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4033858', 'cui_str': 'bevacizumab Injection [Avastin]'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein Angiography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}]",,0.067992,IVB-treated eyes tended to have thinner foveal thickness than laser-treated eyes (mean difference:,"[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Lepore', 'Affiliation': ''}, {'ForeName': 'Marco H', 'Initials': 'MH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Quinn', 'Affiliation': ''}, {'ForeName': 'Giulia M', 'Initials': 'GM', 'LastName': 'Amorelli', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orazi', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': ''}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': ''}]","Ophthalmic surgery, lasers & imaging retina",['10.3928/23258160-20200228-07'] 558,32209798,Effect of 12-Week Interventions Involving Nordic Walking Exercise and a Modified Diet on the Anthropometric Parameters and Blood Lipid Profiles in Overweight and Obese Ex-Coal Miners.,"BACKGROUND Overweight and obesity after retirement are likely to be caused by unhealthy eating habits and the energy intake exceeding the energy expenditure. OBJECTIVES This study was designed to assess the effects of two 12-week interventions involving, respectively, either regular physical activity or a modified lower-calorie diet on the anthropometric parameters and blood lipid profiles in overweight and obese retired miners with lipid disorders. DESIGN The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm, body weight 96.6 ± 13.9 kg) were randomly assigned to 2 intervention groups: the Nordic walking group (NW), which exercised with intensity from 60 to 70% of participants' maximal heart rates for 1 h 3 times a week, and the modified diet group (MD). Modification of the diet consisted of reducing the daily energy intake by 30%, increasing the dietary content of mono- and polyunsaturated fatty acids and dietary fiber, and reducing the proportion of saturated fatty acids. The variables assessed at baseline and after 6 and 12 weeks were: anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C]). RESULTS The body weight of the participants in the NW was lower at week 12 by an average of 5 kg, BMI by 6%, FB by 19%, FM by 15%, WC by 8%, HC by 6%, and WHR by 3%. In the MD, the respective decreases were 8 kg and 8, 25, 20, 6, 2, and 7%. In the MD, the postintervention concentrations of TC and TG were within the reference range. CONCLUSION Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.",2020,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","['body weight 96.6 ± 13.9 kg', 'Overweight and Obese Ex-Coal Miners', 'overweight and obese retired miners with lipid disorders', 'The study participants (n = 30, aged 58.7 ± 4.1 years, body height 174.8 ± 7.3 cm']","['Nordic walking group (NW', 'regular physical activity or a modified lower-calorie diet', 'Nordic Walking Exercise and a Modified Diet']","['body weight', 'anthropometric parameters (body weight, fat mass content [FM], fat percentage [BF], BMI, waist circumference [WC], hip circumference [HC], and waist-to-hip ratio [WHR]) and blood lipid indicators (total cholesterol [TC], triglycerides [TG], low density lipoprotein cholesterol [LDL-C], and high density lip-oprotein cholesterol [HDL-C', 'anthropometric parameters and blood lipid profiles', 'postintervention concentrations of TC and TG']","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0341671', 'cui_str': 'Coal miner (occupation)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0240346', 'cui_str': 'Mineworkers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0452264', 'cui_str': 'Therapeutic diets (finding)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264657', 'cui_str': 'Mass content'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.014178,"Both 12-week interventions improved the anthropometric parameters and blood lipid profiles of retired heavy manual workers, with the improvements being more pronounced in the dieting group.","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland, e.sadowska-krepa@awf.katowice.pl.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Gdańska', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Rozpara', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Biochemistry and Basic of Cosmetology, University School of Physical Education, Krakow, Poland.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Přidalová', 'Affiliation': 'Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University, Olomouc, Czechia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bańkowski', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}]",Obesity facts,['10.1159/000506403'] 559,32211803,"Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial.","BACKGROUND Postprandial inflammation that occurs concurrently with hyperglycemia and hyperlipidemia after ingestion of a high-saturated-fat, high-carbohydrate meal (HFCM) is a risk factor for cardiovascular disease (CVD). Numerous preclinical and clinical studies demonstrate anti-inflammatory effects of individual spices. However, the effect of consumption of a spice blend on inflammatory mediators has not been examined in a randomized controlled trial. OBJECTIVES The objective of this study was to investigate the postprandial effect of a blend of spices in a HFCM on inflammatory cytokine responses. METHODS Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35 kg/m2), elevated waist circumference (≥ 94 cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n = 12). In random order, participants consumed the following: a HFCM (∼1000 kcal, 33% kcal from saturated fat and 36% kcal from carbohydrate), a HFCM containing 2 g spice blend, or an HFCM containing 6 g spice blend. The spice blend consisted of basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric. Blood was collected before, and hourly for 4 h after the HFCM. Peripheral blood mononuclear cells (PBMCs) were isolated, and the percentage of CD14 +/Human Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations in plasma and LPS-stimulated PBMCs were quantified as secondary outcomes. RESULTS There was a significant spice-by-time interaction on IL-1β (P < 0.001), IL-8 (P = 0.020), and TNF-α (P = 0.009) secretion from LPS-stimulated PBMCs. IL-1β secretion from LPS-stimulated PBMCs was significantly reduced (1314%) at 240 min after HFCM consumption containing 6 g, but not 2 g, of spice blend compared with 0 g spice blend. CONCLUSIONS A HFCM containing 6 g spice blend attenuated HFCM-induced postprandial IL-1β secretion in men with overweight/obesity.This trial was registered at clinicaltrials.gov as NCT03064958.",2020,There was a significant spice-by-time interaction on IL-1β,"['Men with Overweight or Obesity', 'men with overweight/obesity', 'Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35\xa0kg/m2), elevated waist circumference (≥ 94\xa0cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n\xa0=\xa012']","['HFCM', 'carbohydrate meal (HFCM', 'High-Saturated-Fat, High-Carbohydrate Meal', 'HFCM containing 2\xa0g spice blend, or an HFCM containing 6\xa0g spice blend', 'basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric', 'HFCM (∼1000\xa0kcal, 33%\xa0kcal from saturated fat and 36%\xa0kcal from carbohydrate']","['IL-8', 'TNF-α', 'IL-1β secretion from LPS-stimulated PBMCs', 'Postprandial Proinflammatory Cytokine Secretion', 'percentage of CD14 +/Human', 'Peripheral blood mononuclear cells (PBMCs', 'IL-1β', 'postprandial IL-1β secretion', 'Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0600402', 'cui_str': 'Basil'}, {'cui': 'C0453244', 'cui_str': 'Bay Leaf'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0162747', 'cui_str': 'Coriander'}, {'cui': 'C0524875', 'cui_str': 'Cumin'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0453263', 'cui_str': 'Oregano'}, {'cui': 'C0994493', 'cui_str': 'Parsley'}, {'cui': 'C0446306', 'cui_str': 'Bell Pepper'}, {'cui': 'C1262899', 'cui_str': 'Rosemary (substance)'}, {'cui': 'C1305848', 'cui_str': 'Thyme'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0907223,There was a significant spice-by-time interaction on IL-1β,"[{'ForeName': 'Ester S', 'Initials': 'ES', 'LastName': 'Oh', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Connie J', 'Initials': 'CJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa063'] 560,32212335,Forty-year trends in menopausal hormone therapy use and breast cancer incidence among postmenopausal black and white women.,"After reports from the Women's Health Initiative randomized trial evaluating estrogen plus progestin, there was a sudden, substantial, and sustained decrease in all categories of menopausal hormone therapy, and the first reduction in age-adjusted breast cancer incidence in more than 20 years was seen in 2003-2004 among US women 50 years of age or older. Subsequent trends in breast cancer incidence have been described, but most reports have not focused on the postmenopausal age group or fully engaged the potential influence of reduced hormone therapy on breast cancer incidence trends by race/ethnicity. To address this gap, this commentary examines trends for annual age-adjusted breast cancer incidence over a 40-year period from 1975 to 2015 for white and black women on the basis of findings from the Surveillance, Epidemiology, and End Results 9 registries. Overall, the sharp decline in breast cancer incidence seen in 2003-2004 was followed in the subsequent decade by a continued low breast cancer incidence plateau in white women that has largely persisted. In contrast, a new discordance between breast cancer incidence trends in black and white women has emerged. In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women. This commentary explores the hypothesis that the over-decade-long and discordant changes in breast cancer incidence rates in postmenopausal black and white women are, to a large extent, associated with changes in hormone therapy use in these 2 groups.",2020,"In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women.","['postmenopausal black and white women', 'black and white women', 'annual age-adjusted breast cancer incidence over a 40-year period from 1975 to 2015 for white and black women']","['menopausal hormone therapy', 'estrogen plus progestin']",['breast cancer incidence'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0180271,"In the 2005-2015 decade, a sustained increase in breast cancer incidence in black women has resulted in annual incidence rates comparable, for the first time, to those in white women.","[{'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Cancer,['10.1002/cncr.32846'] 561,31932093,The Association between Medication Adherence and Visual Field Progression in the Collaborative Initial Glaucoma Treatment Study.,"PURPOSE To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma. PARTICIPANTS Three hundred seven participants randomized to the medication arm of the CIGTS. METHODS Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, ""Did you happen to miss any dose of your medication yesterday?"" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported. MAIN OUTCOME MEASURE Mean deviation over time. RESULTS Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval [CI], 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P < 0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P < 0.0001). CONCLUSIONS This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.",2020,Worse medication adherence was associated with loss of MD over time (P = 0.005).,"['Three hundred seven subjects (306 with adherence data', 'One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up', 'participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS', 'Three hundred seven participants randomized to the medication arm of the CIGTS', '607 participants with newly diagnosed glaucoma', 'Participants were followed up at 6-month intervals for up to 10 years']",['topical medications to trabeculectomy'],"['Self-reported medication adherence and visual fields', 'Mean deviation over time', 'Worse medication adherence', 'MD loss', 'missing medication', 'Medication adherence', 'mean deviation (MD', 'medication nonadherence and glaucomatous vision loss']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0746935', 'cui_str': 'Medication Non-Adherence'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",607.0,0.0846201,Worse medication adherence was associated with loss of MD over time (P = 0.005).,"[{'ForeName': 'Paula Anne', 'Initials': 'PA', 'LastName': 'Newman-Casey', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan. Electronic address: panewman@med.umich.edu.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Niziol', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Janz', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Lichter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology,['10.1016/j.ophtha.2019.10.022'] 562,32208960,"Randomized, Phase II Study of Trastuzumab Beyond Progression in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer: WJOG7112G (T-ACT Study).","PURPOSE This study evaluated the continuous use of trastuzumab beyond progression (TBP) in human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer. PATIENTS AND METHODS Patients with HER2-positive advanced G/GEJ cancer refractory to first-line chemotherapy with trastuzumab in combination with fluoropyrimidine and platinum were eligible. Patients were randomly assigned to the paclitaxel (80 mg/m 2 , days 1, 8, and 15, every 4 weeks) or paclitaxel with trastuzumab (PT; initially 8 mg/kg followed by 6 mg/kg, every 3 weeks) arms. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), response rate, and safety. Biomarkers such as HER2 expression status in tumor tissue after first-line treatment, HER2 amplification evaluated in serum cell-free DNA, and soluble HER2 levels were analyzed. RESULTS Overall, 91 patients were allocated to the paclitaxel (n = 46) and PT (n = 45) arms. The median PFS in the paclitaxel and PT arms was 3.2 and 3.7 months, respectively (hazard ratio [HR], 0.91; 80% CI, 0.67 to 1.22; P = .33), and the median OS in both arms was 10 months (HR, 1.2; 95% CI, 0.75 to 2.0; P = .20). The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms. On exploratory analyses, HER2 positivity of tumor tissues was lost after first-line chemotherapy in 11 (69%) of 16 patients whose tumor tissues were available, and circulating HER2 DNA amplification was detected in 41 (60%) of 68 patients. However, no biomarkers associated with efficacy of TBP were found. CONCLUSION The TBP strategy failed to improve PFS in patients with HER2-positive advanced G/GEJ cancer, and no beneficial biomarkers were found.",2020,"The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms.","['patients with HER2-positive advanced G/GEJ cancer', 'human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (G/GEJ) cancer', 'Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer', 'Patients with HER2-positive advanced G/GEJ cancer refractory to first-line chemotherapy with trastuzumab in combination with fluoropyrimidine and platinum were eligible']","['paclitaxel', 'Trastuzumab', 'trastuzumab beyond progression (TBP', 'paclitaxel with trastuzumab (PT']","['progression-free survival (PFS', 'serum cell-free DNA, and soluble HER2 levels', 'overall response rates', 'overall survival (OS), response rate, and safety', 'safety', 'median OS', 'efficacy of TBP', 'HER2 positivity of tumor tissues', 'circulating HER2 DNA amplification', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4289789', 'cui_str': 'Cell-Free Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0077021', 'cui_str': 'tributyl phosphate'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]",91.0,0.0358433,"The overall response rates in the paclitaxel and PT arms were 32% and 33%, respectively ( P = 1.00), and safety was comparable between the 2 arms.","[{'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka; and Cancer Center, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Sukawa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kashiwada', 'Affiliation': 'Department of Hematology/Oncology, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kawada', 'Affiliation': 'Department of Surgery, Kaizuka City Hospital, Osaka, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Horie', 'Affiliation': 'Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kita-gun, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanioka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Uchino', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of GI Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tsukuda', 'Affiliation': 'Department of Oncology, Izumi City General Hospital, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Health Organization, Mito Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Clinical Trial Coordination Unit and Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Division of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03077'] 563,32209338,"Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial.","BACKGROUND In the PACIFIC trial, durvalumab significantly improved progression-free and overall survival (PFS/OS) versus placebo, with manageable safety, in unresectable, stage III non-small-cell lung cancer (NSCLC) patients without progression after chemoradiotherapy (CRT). We report exploratory analyses of outcomes by tumour cell (TC) programmed death-ligand 1 (PD-L1) expression. PATIENTS AND METHODS Patients were randomly assigned (2:1) to intravenous durvalumab 10 mg/kg every 2 weeks or placebo ≤12 months, stratified by age, sex, and smoking history, but not PD-L1 status. Where available, pre-CRT samples were tested for PD-L1 expression (immunohistochemistry) and scored at pre-specified (25%) and post hoc (1%) TC cut-offs. Treatment-effect hazard ratios (HRs) were estimated from unstratified Cox proportional hazards models (Kaplan-Meier-estimated medians). RESULTS In total, 713 patients were randomly assigned, 709 of whom received at least 1 dose of study treatment durvalumab (n = 473) or placebo (n = 236). Some 451 (63%) were PD-L1-assessable: 35%, 65%, 67%, 33%, and 32% had TC ≥25%, <25%, ≥1%, <1%, and 1%-24%, respectively. As of 31 January 2019, median follow-up was 33.3 months. Durvalumab improved PFS versus placebo (primary-analysis data cut-off, 13 February 2017) across all subgroups [HR, 95% confidence interval (CI); medians]: TC ≥25% (0.41, 0.26-0.65; 17.8 versus 3.7 months), <25% (0.59, 0.43-0.82; 16.9 versus 6.9 months), ≥1% (0.46, 0.33-0.64; 17.8 versus 5.6 months), <1% (0.73, 0.48-1.11; 10.7 versus 5.6 months), 1%-24% [0.49, 0.30-0.80; not reached (NR) versus 9.0 months], and unknown (0.59, 0.42-0.83; 14.0 versus 6.4 months). Durvalumab improved OS across most subgroups (31 January 2019 data cut-off; HR, 95% CI; medians): TC ≥ 25% (0.50, 0.30-0.83; NR versus 21.1 months), <25% (0.89, 0.63-1.25; 39.7 versus 37.4 months), ≥1% (0.59, 0.41-0.83; NR versus 29.6 months), 1%-24% (0.67, 0.41-1.10; 43.3 versus 30.5 months), and unknown (0.60, 0.43-0.84; 44.2 versus 23.5 months), but not <1% (1.14, 0.71-1.84; 33.1 versus 45.6 months). Safety was similar across subgroups. CONCLUSIONS PFS benefit with durvalumab was observed across all subgroups, and OS benefit across all but TC <1%, for which limitations and wide HR CI preclude robust conclusions.",2020,"Safety was similar across subgroups. ","['unresectable, Stage III NSCLC patients without progression after chemoradiotherapy (CRT', 'Patients']","['durvalumab 10 mg/kg intravenously every-2-weeks or placebo', 'durvalumab', 'durvalumab by tumour PD-L1 expression', 'placebo']","['Durvalumab improved PFS', 'Durvalumab improved OS', 'PD-L1-evaluable', 'progression-free and overall survival', 'Safety']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.426267,"Safety was similar across subgroups. ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, Lung Cancer Unit CNIO-H12o, CiberOnc and Universidad Complutense, Madrid, Spain. Electronic address: lpazaresr@seom.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spira', 'Affiliation': 'Virginia Health Specialists, Fairfax, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Raben', 'Affiliation': 'Department of Radiation Oncology, University of Colorado Denver, Aurora, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Department of Medical Oncology, Thoracic Unit, Villejuif, France.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University - Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga and Sarah Cannon Research Institute, Nashville, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Clinical Oncology, H.U.V. Macarena, Seville, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital and University of Sydney, Sydney, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spigel', 'Affiliation': 'Tennessee Oncology, Chattanooga and Sarah Cannon Research Institute, Nashville, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Perez', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}, {'ForeName': 'A-M', 'Initials': 'AM', 'LastName': 'Boothman', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Broadhurst', 'Affiliation': 'Plus-Project Ltd, Alderley Park, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'AstraZeneca, Alderley Park, UK.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.03.287'] 564,31391203,Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).,"OBJECTIVE GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort. RESEARCH DESIGN AND METHODS Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c 6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine. RESULTS At baseline, GRADE's 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA 1c of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m 2 , and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease). CONCLUSIONS The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.",2019,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","['Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c 6.8-8.5% (51-69 mmol/mol), prescribed', 'requiring a second diabetes medication', '5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino', 'people with type 2 diabetes (T2DM', 'GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort', 'Diabetes', 'NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease']","['metformin monotherapy', 'metformin', 'glimepiride, sitagliptin, liraglutide, or insulin glargine']","['history of hypertension', 'history of heart attack or stroke']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",69.0,0.0711735,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA grademail@bsc.gwu.edu.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, MD.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Hermes J', 'Initials': 'HJ', 'LastName': 'Florez', 'Affiliation': 'University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hox', 'Affiliation': 'Pacific Health Research & Education Institute, Honolulu, HI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Underkofler', 'Affiliation': 'University of Colorado, Denver, Denver, CO.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0901'] 565,32191722,Effects of oxytocin administration and conditioned oxytocin on brain activity: An fMRI study.,"It has been demonstrated that secretion of several hormones can be classically conditioned, however, the underlying brain responses of such conditioning have never been investigated before. In this study we aimed to investigate how oxytocin administration and classically conditioned oxytocin influence brain responses. In total, 88 females were allocated to one of three groups: oxytocin administration, conditioned oxytocin, or placebo, and underwent an experiment consisting of three acquisition and three evocation days. Participants in the conditioned group received 24 IU of oxytocin together with a conditioned stimulus (CS) during three acquisition days and placebo with the CS on three evocation days. The oxytocin administration group received 24 IU of oxytocin and the placebo group received placebo during all days. On the last evocation day, fMRI scanning was performed for all participants during three tasks previously shown to be affected by oxytocin: presentation of emotional faces, crying baby sounds and heat pain. Region of interest analysis revealed that there was significantly lower activation in the right amygdala and in two clusters in the left superior temporal gyrus in the oxytocin administration group compared to the placebo group in response to observing fearful faces. The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group. No group differences were found in the other tasks. Preliminary evidence was found for brain activation of a conditioned oxytocin response; however, despite this trend in the expected direction, the conditioned group did not significantly differ from other groups. Future research should, therefore, investigate the optimal timing of conditioned endocrine responses and study whether the findings generalize to other hormones as well.",2020,The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group.,['88 females'],"['oxytocin administration and conditioned oxytocin', 'placebo', 'oxytocin', 'conditioned oxytocin', 'oxytocin administration and classically conditioned oxytocin', 'oxytocin together with a conditioned stimulus (CS', 'oxytocin administration, conditioned oxytocin, or placebo']","['emotional faces, crying baby sounds and heat pain', 'brain activation', 'brain activity']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",88.0,0.143848,The activation in the conditioned oxytocin group was in between the other two groups for these clusters but did not significantly differ from either group.,"[{'ForeName': 'Aleksandrina', 'Initials': 'A', 'LastName': 'Skvortsova', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Mischa', 'Initials': 'M', 'LastName': 'de Rover', 'Affiliation': 'Leiden Institute for Brain and Cognition, Leiden, the Netherlands.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Pacheco-Lopez', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Leiden Institute for Brain and Cognition, Leiden, the Netherlands.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Faculty of Social and Behavioural Sciences, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}]",PloS one,['10.1371/journal.pone.0229692'] 566,32191729,Improving Skin-to-Skin Practice for babies in Kangaroo Mother Care in Malawi through the use of a customized baby wrap: A randomized control trial.,"BACKGROUND Complications of prematurity are a leading cause of newborn death in Malawi. Despite early adoption of Kangaroo mother care (KMC), coverage remains low and women have expressed challenges in using the traditional wrapper-chitenje. In 2016, a study was conducted to evaluate the acceptability and effectiveness of a customized KMC wrap in improving adherence to KMC practices among mothers. METHODS Mother-baby dyads (301) were randomized to receive either a customized CarePlus Wrap developed by Lærdal Global Health or a traditional chitenje. Enrolled mother-baby dyads were assessed in the KMC ward at 2-3 days after of admission, and then again at 7-15 days post-discharge. Topics covered included skin-to-skin practices, breastfeeding, perceptions of the wrap, and family/community support. Chi square tests were used to assess associations between wrap type and KMC practices. The study received ethics approval. RESULTS This study found that a customized KMC wrap is highly acceptable to women and improved skin-to-skin practices in facility-based KMC: 44% of mothers using a customized wrap reported 20 or more hours per day, compared to 33% of mothers using the traditional chitenje. Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%). At the time of discharge from KMC, more women who used the customized wrap were satisfied with the wrap than those who used the traditional chitenje (94% vs. 56%). The customized wrap did not appear to impact other newborn practices, such as breastfeeding. CONCLUSIONS This study provides evidence that a customized KMC wrap is highly acceptable to mothers, and it can contribute to better skin-to-skin practices. Use of a customized wrap may be one mechanism to support mothers in practicing KMC and skin-to-skin contact in addition to other interventions.",2020,"Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%).","['mothers', 'Mother-baby dyads (301']","['customized KMC wrap', 'customized KMC', 'customized CarePlus Wrap developed by Lærdal Global Health or a traditional chitenje']",['acceptability and effectiveness'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",301.0,0.0308244,"Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%).","[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chavula', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Guenther', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Valsangkar', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Lwesha', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Gedesi', 'Initials': 'G', 'LastName': 'Banda', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Marte', 'Initials': 'M', 'LastName': 'Bøe Wensaas', 'Affiliation': 'Save the Children, Olso, Norway.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Luhanga', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Chimtembo', 'Affiliation': 'Save the Children, Lilongwe, Malawi.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Kinney', 'Affiliation': 'Department of Global Health, Save the Children US, Washington, DC, United States of America.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}]",PloS one,['10.1371/journal.pone.0229720'] 567,32208898,The impact of mental health diagnoses on perceptions of risk of criminality.,"BACKGROUND Previous research has examined the relation between mental illness (MI) and perceptions of dangerousness, but less research has focused on its relation to perceived risk of criminality. Individuals with MI are perceived to be more dangerous than those without, and individuals with schizophrenia or substance abuse diagnoses are viewed as being more dangerous. Research also supports that race of individuals with MI plays an important role in the conceptualization and experience of stigma. AIMS The current study investigated the relation between MI, perceived criminality and race of diagnosed individuals. METHOD Two hundred ninety participants were randomly assigned to read one of the four vignettes and answer a series of questions. The first three vignettes depicted someone with MI (schizophrenia, depression or alcohol dependency), while the fourth vignette served as a control. Participants were asked to indicate likelihood of committing a future crime, severity of the future crime and the person's potential for rehabilitation. Levels of sympathy and trust, as well as perceived race of the person, were also measured. RESULTS Presence of MI was a significant predictor where MI elicited higher levels of perceived risk of criminality. The remaining predictor variables (type of MI, familiarity with MI and criminality and perceived race) were not significant predictors. Exploratory analyses revealed the schizophrenia and alcohol dependency conditions elicited higher levels of perceived severity of future crimes. Perceived MI severity and likelihood of rehabilitation were all significantly correlated with perceived risk of criminality. CONCLUSION Presence of MI appears to be the most important in influencing participant attitudes about perceived risk of criminality, though type of MI may influence beliefs about severity of future crimes. The impact of race could not be examined but should be examined in future studies.",2020,"The remaining predictor variables (type of MI, familiarity with MI and criminality and perceived race) were not significant predictors.","['Two hundred ninety participants', 'Individuals with MI']",[],"['Levels of sympathy and trust, as well as perceived race of the person', 'remaining predictor variables (type of MI, familiarity with MI and criminality and perceived race', 'Perceived MI severity and likelihood of rehabilitation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0178573', 'cui_str': 'Illicit Behavior'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",290.0,0.0239088,"The remaining predictor variables (type of MI, familiarity with MI and criminality and perceived race) were not significant predictors.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, Loyola University Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Adanna J', 'Initials': 'AJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Marianna E', 'Initials': 'ME', 'LastName': 'Carlucci', 'Affiliation': 'Department of Psychology, Loyola University Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Grover', 'Affiliation': 'Department of Psychology, Loyola University Maryland, Baltimore, MD, USA.'}]",The International journal of social psychiatry,['10.1177/0020764020913322'] 568,31821429,Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial.,"Importance The clinical consequences of red blood cell storage age for critically ill pediatric patients have not been examined in a large, randomized clinical trial. Objective To determine if the transfusion of fresh red blood cells (stored ≤7 days) reduced new or progressive multiple organ dysfunction syndrome compared with the use of standard-issue red blood cells in critically ill children. Design, Setting, and Participants The Age of Transfused Blood in Critically-Ill Children trial was an international, multicenter, blinded, randomized clinical trial, performed between February 2014 and November 2018 in 50 tertiary care centers. Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission. A total of 15 568 patients were screened, and 13 308 were excluded. Interventions Patients were randomized to receive either fresh or standard-issue red blood cells. A total of 1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group. Main Outcomes and Measures The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death. Results Among 1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group. The median storage duration was 5 days (interquartile range [IQR], 4-6 days) in the fresh group vs 18 days (IQR, 12-25 days) in the standard-issue group (P < .001). There were no significant differences in new or progressive multiple organ dysfunction syndrome between fresh (147 of 728 [20.2%]) and standard-issue red blood cell groups (133 of 732 [18.2%]), with an unadjusted absolute risk difference of 2.0% (95% CI, -2.0% to 6.1%; P = .33). The prevalence of sepsis was 25.8% (160 of 619) in the fresh group and 25.3% (154 of 608) in the standard-issue group. The prevalence of acute respiratory distress syndrome was 6.6% (41 of 619) in the fresh group and 4.8% (29 of 608) in the standard-issue group. Intensive care unit mortality was 4.5% (33 of 728) in the fresh group vs 3.5 % (26 of 732) in the standard-issue group (P = .34). Conclusions and Relevance Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells. Trial Registration ClinicalTrials.gov Identifier: NCT01977547.",2019,"Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells. ","['1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group', 'critically ill pediatric patients', 'A total of 15\u202f568 patients were screened, and 13\u202f308 were excluded', 'Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission', 'Critically Ill Pediatric Patients', '1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group', 'critically ill children', 'February 2014 and November 2018 in 50 tertiary care centers']","['Fresh vs Standard-issue Red Blood Cell Transfusions', 'fresh or standard-issue red blood cells']","['acute respiratory distress syndrome', 'prevalence of sepsis', 'new or progressive multiple organ dysfunction syndrome', 'median storage duration', 'new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death', 'incidence of new or progressive multiple organ dysfunction syndrome (including mortality', 'Intensive care unit mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]","[{'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",1538.0,0.188416,"Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells. ","[{'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': ""Division of Pediatric Critical Care, Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Ottawa Hospital Research Institute, Departments of Medicine & Surgery, University of Ottawa School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': ""Division of Pediatric Critical Care, Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Hébert', 'Affiliation': ""Département de médecine, Centre de recherche du CHUM and Chaire de médecine transfusionnelle Héma-Québec-Bayer de l'Université de Montréal, Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leteurtre', 'Affiliation': 'Université de Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, CHU Lille, Réanimation Pédiatrique, Lille, France.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Doctor', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Berg', 'Affiliation': ""The Children's Hospital of Philadelphia, Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia.""}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Bockelmann', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Caro', 'Affiliation': 'London School of Economics, London, United Kingdom.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Chiusolo', 'Affiliation': ""Department of Anesthesia and Critical Care, Bambino Gesù Children's Hospital, Rome, Italy.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Clayton', 'Affiliation': ""Division of Pediatric Critical, Department of Pediatrics, Centre Hospitalier Universitaire (CHU) Sainte-Justine Université de Montréal and Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Cholette', 'Affiliation': ""Division of Critical Care and Cardiology, Department of Pediatrics, University of Rochester Golisano Children's Hospital, Rochester, New York.""}, {'ForeName': 'Gonzalo Garcia', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cassandra D', 'Initials': 'CD', 'LastName': 'Josephson', 'Affiliation': 'Departments of Pathology and Pediatrics, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kusum', 'Initials': 'K', 'LastName': 'Menon', 'Affiliation': ""Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Muszynski', 'Affiliation': ""Division of Critical Care Medicine, Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': 'Nellis', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sarpal', 'Affiliation': ""Western University, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schafer', 'Affiliation': 'Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marie E', 'Initials': 'ME', 'LastName': 'Steiner', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Research CHU de Québec-Université Laval Centre, Population Health and Optimal Health Practices and Research Unit, Trauma, Emergency, Critical Care Medicine, Université Laval and Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.17478'] 569,30944045,Victory is its own reward: oxytocin increases costly competitive behavior in schizophrenia.,"BACKGROUND Aberrant sensitivity to social reward may be an important contributor to abnormal social behavior that is a core feature of schizophrenia. The neuropeptide oxytocin impacts the salience of social information across species, but its effect on social reward in schizophrenia is unknown. METHODS We used a competitive economic game and computational modeling to examine behavioral dynamics and oxytocin effects on sensitivity to social reward among 39 men with schizophrenia and 54 matched healthy controls. In a randomized, double-blind study, participants received one dose of oxytocin (40 IU) or placebo and completed a 35-trial Auction Game that quantifies preferences for monetary v. social reward. We analyzed bidding behavior using multilevel linear mixed models and reinforcement learning models. RESULTS Bidding was motivated by preferences for both monetary and social reward in both groups, but bidding dynamics differed: patients initially overbid less compared to controls, and across trials, controls decreased their bids while patients did not. Oxytocin administration was associated with sustained overbidding across trials, particularly in patients. This drug effect was driven by a stronger preference for winning the auction, regardless of monetary consequences. Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards. CONCLUSIONS Our findings suggest that schizophrenia is associated with diminished motivation for social reward that may be increased by oxytocin administration.",2020,"Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards. ",['39 men with schizophrenia and 54 matched healthy controls'],"['neuropeptide oxytocin', 'placebo', 'oxytocin', 'Oxytocin']",['Learning rate and response variability'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",39.0,0.338029,"Learning rate and response variability did not differ between groups or drug condition, suggesting that differences in bidding derive primarily from differences in the subjective value of social rewards. ","[{'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Bradley', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Brustkern', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van den Bos', 'Affiliation': 'Center for Adaptive Rationality, Max Planck Institute for Human Development, Berlin, Germany.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'McClure', 'Affiliation': 'Department of Psychology, Arizona State University, TempeAZ, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Seitz', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA94110, USA.'}]",Psychological medicine,['10.1017/S0033291719000552'] 570,32207140,Cost-effectiveness of Medical Expulsive Therapy with Alpha-blockers for Large Distal Ureteral Stones in China.,"PURPOSE To assess the cost-effectiveness of medical expulsive therapy (MET) versus observation for large distal ureteral stones in China and provide preliminary evidence for the determination of the course of MET by mathematical estimation. MATERIALS AND METHODS With linear success rate assumptions, a decision tree was constructed by TreeAge Pro 2011 software. The stones passage rates after observation or receiving 0.4 mg daily tamsulosin were estimated according to a large randomized clinical trial (RCT). The costs of ureteroscopy, drugs and examinations were estimated according to related price from pharmacies or hospitals, or the guidance price published by the government. MET was also compared with observation by the sensitivity analysis. The effectiveness of MET or observation was presented by quality-adjusted life-day. Mathematical estimation of stone expulsion time was made by using a decision-analytic Markov model under the assumption that the daily stone expulsion probability is constant. RESULTS In China, the MET was associated with a $295.1 cost advantage over observation. The cost of ureteroscopy has to decrease to $77.8 to reach cost equivalence between observation and MET. Observation is cost-effective only if ureteroscopy is very cheap or the difference of stone expulsion rates is insignificant. The estimated expulsion time was much longer than those reported in above mentioned RCT. CONCLUSION Due to the high cost of ureteroscopy, MET showed a cost advantage over observation in treating distal ureteral stones in China. The daily stone passage rate was inconstant. More studies are needed to find the appropriate duration of MET.",2020,The daily stone passage rate was inconstant.,['Large Distal Ureteral Stones in China'],"['tamsulosin', 'medical expulsive therapy (MET', 'Medical Expulsive Therapy']","['daily stone passage rate', 'stone expulsion rates', 'cost-effectiveness', 'stones passage rates', 'costs of ureteroscopy, drugs and examinations', 'estimated expulsion time']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.033047,The daily stone passage rate was inconstant.,"[{'ForeName': 'Yucong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ouyang', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xifeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Zhangqun', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Jinchun', 'Initials': 'J', 'LastName': 'Xing', 'Affiliation': 'Department of Urology, The first affiliated hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}]",Urology journal,['10.22037/uj.v0i0.5433'] 571,32402702,Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.,"BACKGROUND Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. METHODS The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. RESULTS More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. CONCLUSION This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",2020,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. ","['high-risk PCI patients', 'high-risk patients who underwent percutaneous coronary intervention', 'patients with high-risk anatomic or clinical characteristics who underwent PCI', '1700 high-risk PCI patients']","['routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing', 'routine versus no routine functional testing', 'percutaneous coronary intervention (PCI) with drug-eluting stents (DES']","['composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0562340', 'cui_str': 'Poor daily routine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",,0.0929061,"The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. ","[{'ForeName': 'Yong-Hoon', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Cheol', 'Initials': 'SC', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Won-Jang', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Chul Soo', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': ""Cardiovascular Center and Cardiology Division, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Ki', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Kangwon National University Hospital, Chuncheon, Republic of Korea.'}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Wonju Christian Hospital, Wonju, Republic of Korea.'}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Eulji General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Sik', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Su Nam', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea.""}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.03.019'] 572,32272214,Hematoporphyrin monomethyl ether mediated sonodynamic antimicrobial chemotherapy on porphyromonas gingivalis in vitro.,"This study aimed to evaluate the efficacy of hematoporphyrin monomethyl ether (HMME)-mediated sonodynamic antimicrobial chemotherapy (SACT) on Porphyromonas gingivalis (P. gingivalis). P. gingivalis (ATCC 33277) was used in the present study. The bacterial suspension was randomly divided into five groups: Group 1 was incubated for 2 h in the dark with HMME in various concentrations (10, 20, 30 and 40 μg/mL). Then exposed to 1 MHz ultrasound frequency with 3 W/cm 2 ultrasound intensity for 10 min. Group 2 was incubated with 40 μg/mL HMME and then irradiated with 2, 4, 6, 8 and 10 min ultrasonic time. Group 3 received different HMME concentration (10, 20, 30 and 40 μg/mL) treatment alone with no ultrasound as the HMME control group. Group 4 received ultrasound treatment alone in different ultrasonic time (2, 4, 6, 8 and 10 min) with no HMME as the ultrasound control group. Group 5 received no treatment as the no treatment control group. After the SACT, the bactericidal effect was determined by the colony forming unit assay. The intracellular content of reactive oxygen species (ROS) was detected using the laser scanning confocal microscope based on DCFH-DA. 4.7 lg reduction in CFU, When P. gingivalis was treated with ultrasound (3 W/cm 2 for 10 min) at 40 μg/mL HMME concentration (P < 0.01). The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P < 0.01). HMME mediated SACT can be a potential antibacterial therapy to significantly inhibit P. gingivalis growth.",2020,The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P<0.01).,[],"['HMME mediated SACT', 'ultrasound treatment alone', 'hematoporphyrin monomethyl ether (HMME)-mediated sonodynamic antimicrobial chemotherapy (SACT', 'Hematoporphyrin monomethyl ether mediated sonodynamic antimicrobial chemotherapy', 'HMME concentration (10, 20, 30 and 40 μg/mL) treatment alone with no ultrasound as the HMME control group']","['intracellular content of reactive oxygen species (ROS', 'bactericidal effect', 'intracellular ROS']",[],"[{'cui': 'C1530433', 'cui_str': 'hematoporphyrin monomethyl ether'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0198217,The intracellular ROS in SDT group had a significant difference in comparison with the no treatment control group (P<0.01).,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China. Electronic address: zoeyzhang0415@163.com.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China; Department of Restorative Dentistry, Faculty of Dental Medicine and Graduate School of Dental Medicine, Hokkaido University, Sapporo, 0600808, Japan. Electronic address: zhanghongbo606@163.com.'}, {'ForeName': 'Deshu', 'Initials': 'D', 'LastName': 'Zhuang', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China; Faculty of Dentistry, Department of Oral Biological and Medical Sciences, University of British Columbia, Vancouver, BC V6T 1Z3, Canada. Electronic address: stevenchuang88@126.com.'}, {'ForeName': 'Liangjia', 'Initials': 'L', 'LastName': 'Bi', 'Affiliation': 'Department of Stomatology, The Fourth Affiliated Hospital, Harbin Medical University, Harbin, 150001, China. Electronic address: biliangjia6601@126.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, 150080, China. Electronic address: huzheng0010@163.com.'}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, 150080, China; Department of Mathematics and Materials Research Institute, The Pennsylvania State University, University Park, PA, 16802, USA. Electronic address: caowenwu808@163.com.'}]",Microbial pathogenesis,['10.1016/j.micpath.2020.104192'] 573,32404287,Cardiopulmonary exercise testing and aerobic treadmill training after stroke: Feasibility of a controlled trial.,"PURPOSE To investigate the feasibility and safety of a randomized controlled trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training in individuals in the chronic phase after stroke. METHODS The following data were recorded: number of individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events. RESULTS From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental). The main source of recruitment was other research projects (43.5%). The main reason for exclusion was unavailability (22%). Six out of 39 individuals (15.4%) that attended in the evaluation session were not able to perform the cardiopulmonary exercise testing. All subjects included showed a respiratory exchange ratio ≥1.0 (considered as maximal effort in the CPET). Retention rate was 81% and the main reason of withdrawal was unavailability (75%). The overall attendance rate was 88% and the main reason for non-attendance was illness/sickness (20.8%). The adherence rate was 99% and the reasons for non-completing sessions were illness/sickness (60%) or delay (40%). No serious adverse events occurred. CONCLUSION Recruitment rate was low, retention rate was moderate, attendance and adherence rates were high. No serious adverse events occurred. It was feasible and safe to execute a randomized clinical trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training.",2020,"No serious adverse events occurred. ","['From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental', 'individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events', 'individuals in the chronic phase after stroke']","['cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training', 'Cardiopulmonary exercise testing and aerobic treadmill training']","['adherence rate', 'overall attendance rate', 'retention rate was moderate, attendance and adherence rates', 'Retention rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.106437,"No serious adverse events occurred. ","[{'ForeName': 'Sherindan Ayessa Ferreira De', 'Initials': 'SAF', 'LastName': 'Brito', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: sherindanayessa@hotmail.com.'}, {'ForeName': 'Larissa Tavares', 'Initials': 'LT', 'LastName': 'Aguiar', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: larissatavaresaguiar@gmail.com.'}, {'ForeName': 'Laura Nolasco', 'Initials': 'LN', 'LastName': 'Garcia', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: lauranolasco15@hotmail.com.'}, {'ForeName': 'Paula Da Cruz', 'Initials': 'PDC', 'LastName': 'Peniche', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: penichepaula@yahoo.com.br.'}, {'ForeName': 'Maria Teresa Ferreira Dos', 'Initials': 'MTFD', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: mariateresafdr@gmail.com.'}, {'ForeName': 'Christina Danielli Coelho De Morais', 'Initials': 'CDCM', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Av. Antônio Carlos, 6627, Campus Pampulha, CEP: 31270-910, Belo Horizonte, Brazil. Electronic address: cdcmf@ufmg.br.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104854'] 574,32206861,Mastopexy with Autologous Augmentation in Women After Massive Weight Loss: A Randomized Clinical Trial.,,2020,,"['After Massive Weight Loss', 'Women']",['Mastopexy with Autologous Augmentation'],[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0191918', 'cui_str': 'Fixation of pendulous breast (procedure)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",[],,0.134257,,"[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China.""}, {'ForeName': 'Dali', 'Initials': 'D', 'LastName': 'Mu', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. doctormudali@hotmail.com.""}]",Aesthetic plastic surgery,['10.1007/s00266-020-01688-0'] 575,32203007,Effects of repleting organic phosphates in banked erythrocytes on plasma metabolites and vasoactive mediators after red cell exchange transfusion in sickle cell disease.,"BACKGROUND Red blood cell (RBC) exchange (RCE) transfusion therapy is indicated for certain patients with sickle cell disease (SCD). Although beneficial, this therapy is costly and inconvenient to patients, who may require it monthly or more often. Identification of blood and plasma biomarkers that could improve or help individualise RCE therapy is of interest. Here we examined relevant blood and plasma metabolites and biomarkers of vasoactivity and RBC fragility in a pilot study of SCD patients undergoing RCE using either standard RBC units or RBC units treated with a US Food and Drug Administration (FDA)-approved additive solution containing phosphate, inosine, pyruvate, and adenine (""PIPA""). MATERIALS AND METHODS In this prospective, single-blind, cross-over pilot clinical trial, patients were randomised to receive either standard RBC exchange or PIPA-treated RBC exchange transfusion with each RCE session over a 6-month treatment period. Pre- and post-transfusion blood samples were obtained and analysed for RBC O 2 affinity, ATP, purine metabolites, RBC microparticles, and cell free haemoglobin. RESULTS Red blood cell O 2 affinity was maintained after PIPA-RCE in contrast to standard RCE, after which P 5 0 fell (net O 2 affinity rose). Plasma ATP did not change significantly after RCE using either of the RBC unit types. Exchange transfusion with PIPA-treated RBC units led to modest increases in plasma inosine and hypoxanthine. Plasma cell free haemoglobin fell after either standard or PIPA-treated RBC exchange transfusion (novel findings), and to a similar extent. RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion. DISCUSSION In summary, treatment of RBCs with PIPA prior to RCE elicited favourable or neutral changes in key metabolic and vascular biomarkers. Further study of its efficacy and safety is recommended and could ultimately serve to improve outcomes in chronically transfused SCD patients.",2020,"RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion. ","['certain patients with sickle cell disease (SCD', 'SCD patients undergoing RCE using either standard RBC units or RBC units treated with a', 'chronically transfused SCD patients', 'sickle cell disease']","['US Food and Drug Administration (FDA)-approved additive solution containing phosphate, inosine, pyruvate, and adenine (""PIPA', 'repleting organic phosphates', 'Red blood cell (RBC) exchange (RCE) transfusion therapy', 'standard RBC exchange or PIPA-treated RBC exchange transfusion with each RCE session']","['Red blood cell O2 affinity', 'plasma metabolites and vasoactive mediators', 'plasma inosine and hypoxanthine', 'RBC O2 affinity, ATP, purine metabolites, RBC microparticles, and cell free haemoglobin', 'Plasma cell free haemoglobin fell', 'Plasma ATP']","[{'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0244104', 'cui_str': 'Pyruvate'}, {'cui': 'C0001407', 'cui_str': 'Adenine'}, {'cui': 'C0031701', 'cui_str': 'Phosphates, Organic'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0015236', 'cui_str': 'Exchange Transfusion, Whole Blood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0220903', 'cui_str': 'purine'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C0032112', 'cui_str': 'Plasmacytes'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",,0.0236441,"RBC-derived microparticles in the plasma fell significantly and similarly after both standard and PIPA-treated RCE transfusion. ","[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Lopez Domowicz', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Welsby', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Esther', 'Affiliation': 'Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Marek', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Poisson', 'Affiliation': 'Department of Pathology, Duke University Medical Center, Durham, NC, United States of America.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'McMahon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, United States of America.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0237-19'] 576,32403938,Effectiveness of embedding a specialist preventive care clinician in a community mental health service in increasing preventive care provision: A randomised controlled trial.,"OBJECTIVE Clinical practice guidelines recommend that community mental health services provide preventive care for clients' chronic disease risk behaviours; however, such care is often not routinely provided. This study aimed to assess the effectiveness of offering clients an additional consultation with a specialist clinician embedded within a community mental health service, in increasing client-reported receipt of, and satisfaction with, preventive care. METHOD A randomised controlled trial was undertaken in one Australian community mental health service. Participants ( N  = 811) were randomised to receive usual care (preventive care in routine consultations; n  = 405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician ( n  = 406). Blinded interviewers assessed at baseline and 1-month follow-up the client-reported receipt of preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity) and all applicable risks combined, acceptance of referrals and satisfaction with preventive care received. RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]). For each component of care, there was a significant intervention effect for at least one of the individual risk behaviours. Participants reported high levels of satisfaction with preventive care received, ranging from 77% (assessment) to 87% (referral), with no significant differences between conditions. CONCLUSION The intervention had a significant effect on the provision of the majority of recommended elements of preventive care. Further research is needed to maximise its impact, including identifying strategies to increase client uptake.",2020,"RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","['one Australian community mental health service', 'Participants ( N \u2009=\u2009811', ""clients' chronic disease risk behaviours""]","['embedding a specialist preventive care clinician', 'preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity', 'usual care (preventive care in routine consultations; n \u2009=\u2009405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician']","['18 preventive care delivery outcomes', 'provision of the majority of recommended elements of preventive care']","[{'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2090905', 'cui_str': 'Specialist consultation'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",811.0,0.0905598,"RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","[{'ForeName': 'Caitlin Mc', 'Initials': 'CM', 'LastName': 'Fehily', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Bartlem', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Wye', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Clancy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Rissel', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wutzke', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hodder', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Colyvas', 'Affiliation': 'School of Mathematical and Physical Sciences, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bowman', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420914741'] 577,32160260,Effect of informatization-based blood glucose team management on the control of hyperglycaemia in noncritical care units.,"PURPOSE To provide a new system of in-hospital blood glucose team management combined with a network blood glucose monitoring system and analyse the effect on hyperglycaemic participants' blood glucose control in noncritical care units. METHODS Hyperglycaemic participants in noncritical care units were divided into two groups. They underwent active intervention by the hospital's blood glucose management team or the routine consultation group. The better method, based on a shorter length of stay (LOS) and lower hospital cost, could be selected by comparing the two blood glucose management strategies. RESULTS Compared with the routine consultation group, the team management group had a higher detection rate of hyperglycaemia (18.49% vs 16.17%, P<0.01) and glycosylated haemoglobin (51.53% vs 30.97%, P<0.01) and a lower incidence rate of hyperglycaemia (59.24% vs 61.59%, P<0.01), severe hyperglycaemia (3.56% vs 5.19%, P<0.01) and clinically significant hypoglycaemia (0.26% vs 0.35%, P<0.05). Simultaneously, blood glucose drift (mmol/L) (2.50 (1.83, 3.25) vs 2.76 (2.01, 3.57), P<0.01), blood glucose coefficient of variation (%) (28.86 (22.70, 34.83) vs 29.80 (23.47, 36.13), P<0.01), maximum blood glucose fluctuation (mmol/L) (9.30 (6.20, 13.10) vs 10.10 (7.00, 14.40), P<0.01) and nosocomial infection (5.42% vs 8.05%, P<0.05) were all lower among participants in the team management group. In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. CONCLUSION In-hospital blood glucose team management combined with a network blood glucose monitoring system effectively improved the blood glucose control and fluctuation levels of participants who were admitted to noncritical care units, thereby reducing LOS and hospital cost.",2020,"In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. ","['hyperglycaemia in noncritical care units', 'Hyperglycaemic participants in noncritical care units', 'participants who were admitted to noncritical care units', ""hyperglycaemic participants' blood glucose control in noncritical care units""]","[""active intervention by the hospital's blood glucose management team or the routine consultation group"", 'informatization-based blood glucose team management', 'network blood glucose monitoring system']","['blood glucose drift (mmol/L', 'severe hyperglycaemia', 'nosocomial infection', 'hospital costs', 'blood glucose control and fluctuation levels', 'detection rate of hyperglycaemia', 'shorter length of stay (LOS) and lower hospital cost', 'glycosylated haemoglobin', 'blood glucose coefficient of variation', 'incidence rate of hyperglycaemia', 'clinically significant hypoglycaemia', 'maximum blood glucose fluctuation']","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1638311', 'cui_str': 'Blood sugar management (procedure)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0877314', 'cui_str': 'Blood glucose fluctuation'}]",,0.0244574,"In addition, the LOS (P<0.001) and hospital costs (P<0.001) of participants were lower in the team management group. ","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xian-Jun', 'Initials': 'XJ', 'LastName': 'Zhu', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Nie', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peng-Qiu', 'Initials': 'PQ', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}]",PloS one,['10.1371/journal.pone.0230115'] 578,31410598,Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients.,"BACKGROUND Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials. OBJECTIVE To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT). METHODS We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve. RESULTS In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05). CONCLUSION In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group. TRIAL REGISTRATION NCT01348048.",2020,"Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05). CONCLUSION In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems.","['Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of', 'advanced cancer patients', '145 patients were randomized to early']","['specialized palliative care plus standard care versus 152 to standard care only', 'specialized palliative care plus standard care versus standard care', 'early specialized palliative care plus standard care versus standard care']","['symptoms or problems', 'Cancer Quality of Life Questionnaire (EORTC QLQ-C30', 'satisfied with the health care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",145.0,0.135597,"Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05). CONCLUSION In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems.","[{'ForeName': 'Anna Thit', 'Initials': 'AT', 'LastName': 'Johnsen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. atjohnsen@health.sdu.dk.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mette Asbjoern', 'Initials': 'MA', 'LastName': 'Neergaard', 'Affiliation': 'Palliative Care Team, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Damkier', 'Affiliation': 'Palliative Team Fyn, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fayers', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen Medical School, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lindschou', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Annette S', 'Initials': 'AS', 'LastName': 'Strömgren', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jan Bjoern', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Palliative Team Herning, Herning Hospital, Herning, Denmark.'}, {'ForeName': 'Irene J', 'Initials': 'IJ', 'LastName': 'Higginson', 'Affiliation': ""King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK.""}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05021-7'] 579,31701861,Effectiveness of a Behavior Change Intervention with Hand Sanitizer Use and Respiratory Hygiene in Reducing Laboratory-Confirmed Influenza among Schoolchildren in Bangladesh: A Cluster Randomized Controlled Trial.,"Schoolchildren are commonly linked to influenza transmission. Handwashing with soap has been shown to decrease infections; however, improving handwashing practices using soap and water is difficult in low-resource settings. In these settings, alternative hygiene options, such as hand sanitizer, could improve handwashing promotion to reduce influenza virus infections. We conducted a cluster randomized control trial in 24 primary schools in Dhaka to assess the effectiveness of hand sanitizer and a respiratory hygiene education intervention in reducing influenza-like illness (ILI) and laboratory-confirmed influenza during June-September 2015. Twelve schools were randomly selected to receive hand sanitizer and respiratory hygiene education, and 12 schools received no intervention. Field staff actively followed children daily to monitor for new ILI episodes (cough with fever) through school visits and by phone if a child was absent. When an illness episode was identified, medical technologists collected nasal swabs to test for influenza viruses. During the 10-week follow-up period, the incidence of ILI per 1,000 student-weeks was 22 in the intervention group versus 27 in the control group ( P -value = 0.4). The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks) ( P -value = 0.01). Hand sanitizer and respiratory hygiene education can help to reduce the risk of influenza virus transmission in schools.",2019,"The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks)","['Schoolchildren in Bangladesh', 'schools', 'Twelve schools', '24 primary schools in Dhaka to assess the effectiveness of hand sanitizer and a respiratory hygiene education intervention in reducing influenza-like illness (ILI) and laboratory-confirmed influenza during June-September 2015']","['hand sanitizer and respiratory hygiene education, and 12 schools received no intervention', 'Behavior Change Intervention with Hand Sanitizer Use and Respiratory Hygiene']",[],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1330330', 'cui_str': 'Hand Disinfectants'}, {'cui': 'C0204945', 'cui_str': 'Hygiene education (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]","[{'cui': 'C1330330', 'cui_str': 'Hand Disinfectants'}, {'cui': 'C0204945', 'cui_str': 'Hygiene education (procedure)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",[],,0.0346467,"The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks)","[{'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Makhdum', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Sanofi US Services Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Roguski', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Probir K', 'Initials': 'PK', 'LastName': 'Ghosh', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shahana', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fosiul A', 'Initials': 'FA', 'LastName': 'Nizame', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Ziaur', 'Initials': 'MZ', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahmudur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research (IEDCR), Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Sturm-Ramirez', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0376'] 580,31955642,Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke.,"Background and Purpose- The prehospital setting is a promising site for therapeutic intervention in stroke, but current stroke screening tools do not account for the evolution of neurological symptoms in this early period. We developed and validated the Paramedic Global Impression of Change (PGIC) Scale in a large, prospective, randomized trial. Methods- In the prehospital FAST-MAG (Field Administration of Stroke Therapy-Magnesium) randomized trial conducted from 2005 to 2013, EMS providers were asked to complete the PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change during transport for consecutive patients transported by ambulance within 2 hours of onset. We analyzed PGIC concurrent validity (compared with change in Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity (compared with National Institutes of Health Stroke Scale severity measure performed in the emergency department), and predictive validity (of neurological deterioration after hospital arrival and of final 90-day functional outcome). We used PGIC to characterize differential prehospital course among stroke subtypes. Results- Paramedics completed the PGIC in 1691 of 1700 subjects (99.5%), among whom 635 (37.5%) had neurological deficit evolution (32% improvement, 5.5% worsening) during a median prehospital care period of 33 (IQR, 27-39) minutes. Improvement was associated with diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits on emergency department arrival, and more frequent nondisabled and independent 3-month outcomes. Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months. Conclusions- The PGIC scale is a simple, validated measure of prehospital patient course that has the potential to provide information useful to emergency department decision-making. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00059332.",2020,"Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.",[],"[' and Purpose', 'Methods', 'Conclusions']","['PGIC Scale (5-point Likert scale values: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened) for neurological symptom change', 'Paramedic Global Impression of Change (PGIC', 'Glasgow Coma Scale, Los Angeles Motor Scale), convergent validity', 'severe neurological deficits', 'diagnosis of cerebral ischemia rather than intracranial hemorrhage, milder stroke deficits', 'neurological deficit evolution']",[],"[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0222045'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0421226', 'cui_str': 'Neurological symptom changes (finding)'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",1700.0,0.0547888,"Conversely, worsening on the PGIC was associated with intracranial hemorrhage, more severe neurological deficits on emergency department arrival, more frequent treatment with thrombolytic therapy, and poor disability outcome at 3 months.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Shkirkova', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Schuberg', 'Affiliation': 'Department of Emergency Medicine (S. Schuberg, M.E.), University of Southern California, Los Angeles.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Balouzian', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Starkman', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Department of Emergency Medicine (S. Schuberg, M.E.), University of Southern California, Los Angeles.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stratton', 'Affiliation': 'Department of Emergency Medicine (S. Starkman, S. Stratton), University of California Los Angeles.'}, {'ForeName': 'Franklin D', 'Initials': 'FD', 'LastName': 'Pratt', 'Affiliation': 'Los Angeles County Fire Department, CA (F.D.P.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hamilton', 'Affiliation': 'School of Public Health (S.H.), University of California Los Angeles.'}, {'ForeName': 'Latisha', 'Initials': 'L', 'LastName': 'Sharma', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (R.C.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Comprehensive Stroke Center (S. Starkman, L.S., D.S.L., J.L.S.), University of California Los Angeles.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'From the Keck School of Medicine (K.S., E.B., N.S.), University of Southern California, Los Angeles.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.026392'] 581,32205595,"Impact of a Progressive Mobility Program on the Functional Status, Respiratory, and Muscular Systems of ICU Patients: A Randomized and Controlled Trial.","OBJECTIVES The aim was to investigate whether patients who participated in a mobility program in the ICU performed better on functional status, muscle, mobility, and respiratory assessments upon discharge than patients who received conventional physiotherapy. DESIGN Randomized controlled trial. SETTING Blind evaluation. PATIENTS Adults with previous functional independence and without contraindications for mobilization were eligible. INTERVENTIONS The intervention group participated in an early and progressive mobility program with five levels of activity. The control group underwent the conventional treatment without a preestablished routine. We evaluated functional status, level of activity, respiratory status, muscle strength, and mobility at ICU discharge. MEASUREMENTS AND MAIN RESULTS We analyzed 49 patients in the control group and 50 patients in the intervention group. Our data showed patients with better functional status and more functionally independent patients in the intervention group compared with those in the control group (96% vs 44%; p < 0.001). The results of the sit-to-stand and 2-minute walk tests, as well as the results of the maximum voluntary ventilation tests, also varied between the groups. The intervention group had shorter ICU stays than the control group. Higher Barthel index scores were associated with the amount of activity and participation in the protocol. The benefits to functional status remained during follow-up. CONCLUSIONS Patients who participated in an ICU mobility program had better functional status at discharge from the ICU. The other benefits of the program included better performance in the mobility tests and improved maximum voluntary ventilation performance.",2020,The intervention group had shorter ICU stays than the control group.,"['patients who participated in a mobility program in the ICU performed better on', 'Adults with previous functional independence and without contraindications for mobilization were eligible', 'ICU Patients']","['Progressive Mobility Program', 'conventional physiotherapy', 'conventional treatment without a preestablished routine']","['functional status, level of activity, respiratory status, muscle strength, and mobility at ICU discharge', 'functional status, muscle, mobility, and respiratory assessments upon discharge', 'shorter ICU stays', 'Higher Barthel index scores', 'functional status', 'maximum voluntary ventilation performance', 'Functional Status, Respiratory, and Muscular Systems']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]","[{'cui': 'C3650998', 'cui_str': 'Advancing mobility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0549075', 'cui_str': 'Respiratory assessment (procedure)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024967', 'cui_str': 'MVV (Ventilation)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0389325,The intervention group had shorter ICU stays than the control group.,"[{'ForeName': 'Debora Stripari', 'Initials': 'DS', 'LastName': 'Schujmann', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Tamires', 'Initials': 'T', 'LastName': 'Teixeira Gomes', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana Claudia', 'Initials': 'AC', 'LastName': 'Lunardi', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Zoccoler Lamano', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Aretha', 'Initials': 'A', 'LastName': 'Fragoso', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mayara', 'Initials': 'M', 'LastName': 'Pimentel', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Neri', 'Initials': 'CN', 'LastName': 'Peso', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Araujo', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, Hospital das Clinicas of University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Department of Physiotherapy, Communication Sciences and Disorders and Occupational Therapy, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Critical care medicine,['10.1097/CCM.0000000000004181'] 582,32402585,Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention.,"BACKGROUND & AIMS The effect of pasta consumption within a low-energy Mediterranean diet on body weight regulation has been scarcely explored. This paper investigates the effect of two Mediterranean diets, which differed for lower or higher pasta intake, on body weight change in individuals with obesity. METHODS & RESULTS Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention. Participants were assigned to a low-energy high pasta (HP) or to a low-energy low Pasta (LP) group on the basis of their pasta intake (HP ≥ 5 or LP ≤ 3 times/week). Anthropometrics, blood pressure and heart rate were measured every month. Weight maintenance was checked at month 12. Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36) were assessed at baseline, 3 and 6 months. Blood samples were collected at baseline and month 6 to assess glucose and lipid metabolism. After 6-month intervention, body weight reduction was -10 ± 8% and -7 ± 4% in HP and LP diet, respectively, and it remained similar at month 12. Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups. No differences were observed for blood pressure and heart rate between treatments and among times. HP diet significantly improved perception of quality of life for the physical component. CONCLUSIONS Independent of pasta consumption frequency, low-energy Mediterranean diets were successful in improving anthropometrics, physiological parameters and dietary habits after a 6-month weight-loss intervention. This trial was registered at clinicaltrials.gov as NCT03341650.",2020,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","['Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention', 'individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention', 'individuals with obesity']","['low-energy high pasta (HP) or to a low-energy low Pasta (LP', 'HP diet', 'Mediterranean diets']","['perception of quality of life', 'Weight maintenance', 'blood pressure and heart rate', 'anthropometrics, physiological parameters and dietary habits', 'glucose and lipid metabolism', 'Blood samples', 'Body weight', 'anthropometric parameters, body composition, glucose and lipid metabolism', 'Anthropometrics, blood pressure and heart rate', 'Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36', 'body weight reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",49.0,0.0258637,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tesan', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Cremonini', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Biasini', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bicchieri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cossu', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': ""Dall'Aglio"", 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy. Electronic address: francesca.scazzina@unipr.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.02.013'] 583,32403130,"Remission of Type 2 Diabetes Following a Short-term Intervention With Insulin Glargine, Metformin, and Dapagliflozin.","OBJECTIVE To examine diabetes remission following a short-term intensive metabolic intervention combining lifestyle and glucose-lowering approaches. METHODS We conducted an open-label, randomized controlled trial in 154 patients with type 2 diabetes up to 8 years in duration on 0 to 2 glucose-lowering medications. Participants were randomized to (a) a 12-week intensive intervention comprising lifestyle approaches and treatment with insulin glargine, metformin, and dapagliflozin or (b) standard diabetes care. At 12 weeks, diabetes medications were discontinued in participants with hemoglobin A1c (HbA1C) < 7.3% (56 mmol/mol). Participants were then followed for diabetes relapse until 64 weeks. The primary outcome was complete or partial diabetes remission (HbA1C < 6.5% [48 mmol/mol] off chronic diabetes drugs) at 24 weeks. Main secondary outcomes were complete or partial diabetes remission at 36, 48, and 64 weeks. RESULTS The primary outcome was achieved in 19 (24.7%) intervention group participants and 13 (16.9%) control group participants at 24 weeks (relative risk [RR] 1.5; 95% confidence interval [CI], 0.8-2.7). The relative risks of remission at 36, 48, and 64 weeks were 2.4 (95% CI, 1.2-5.0), 2.1 (95% CI, 1.0-4.4), and 1.8 (95% CI, 0.7-4.7), respectively. In an exploratory analysis, the intervention reduced the hazard of diabetes relapse with overt hyperglycemia by 43% (hazard ratio 0.57; 95% CI, 0.39-0.81). CONCLUSIONS Our primary outcome of diabetes remission at 24 weeks was not statistically significantly different. However, our overall results suggest that some patients with early type 2 diabetes are able to achieve sustained diabetes remission following a short-term intensive intervention. Further studies are needed to optimize the combined therapeutic approach used.",2020,"The relative risks of remission at 36, 48 and 64 weeks were 2.4 (95% CI 1.2-5.0), 2.1 (95% CI 1.0-4.4) and 1.8 (95% CI 0.7-4.7) respectively.",['154 patients with type 2 diabetes up to 8 years in duration on 0-2 glucose-lowering medications'],"['insulin glargine, metformin and dapagliflozin', 'short-term intensive metabolic intervention combining lifestyle and glucose-lowering approaches', 'intensive intervention comprising lifestyle approaches and treatment with insulin glargine, metformin and dapagliflozin or (ii) standard diabetes care']","['diabetes medications', 'hazard of diabetes relapse with overt hyperglycemia', 'diabetes remission', 'sustained diabetes remission', 'relative risks of remission', 'complete or partial diabetes remission']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3700400', 'cui_str': 'metformin and dapagliflozin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",154.0,0.193999,"The relative risks of remission at 36, 48 and 64 weeks were 2.4 (95% CI 1.2-5.0), 2.1 (95% CI 1.0-4.4) and 1.8 (95% CI 0.7-4.7) respectively.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'McInnes', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Sultan', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes and Endocrinology Community Practice, Toronto, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Woo', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Yan Yun', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa248'] 584,32403207,The effect of insemination methods on in vitro maturation outcomes.,"OBJECTIVE The aim of this study was to compare the effects of conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI) on the fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos derived from in vitro matured oocytes of patients with polycystic ovary syndrome (PCOS). METHODS A prospective study was carried out among 38 PCOS patients who had undergone in vitro maturation (IVM) treatment. In total, 828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes). After fertilization, the embryos were cultured until the blastocyst stage and single embryos were transferred after endometrial preparation and under ultrasound guidance. RESULTS No significant differences were found in the maturation rate (78.1% vs. 72.6% for IVF and ICSI insemination, respectively; p= 0.076), fertilization rate (59.4% vs. 66.9% for IVF and ICSI insemination, respectively; p= 0.063), or the formation of good-quality blastocysts (40.9% vs. 46.5% for IVF and ICSI insemination, respectively; p= 0.314). Implantation and clinical pregnancy also did not show significant differences. CONCLUSION There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination. These findings provide valuable insights for choosing assisted reproductive treatment in women with PCOS, as IVM offers promising outcomes and is less invasive and less costly.",2020,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","['women with PCOS', '38 PCOS patients who had undergone in vitro maturation (IVM) treatment', '828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes', 'patients with polycystic ovary syndrome (PCOS']",['conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI'],"['fertilization rate', 'maturation rate', 'fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos', 'fertilization, blastocyst formation, implantation rate, and clinical pregnancy', 'formation of good-quality blastocysts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",38.0,0.185798,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","[{'ForeName': 'Pallop', 'Initials': 'P', 'LastName': 'Pongsuthirak', 'Affiliation': 'Department of Obstetrics and Gynecology, Buddhachinaraj Hospital Medical School, Phitsanulok, Thailand.'}]",Clinical and experimental reproductive medicine,['10.5653/cerm.2019.03300'] 585,32272505,Exclusion of Men from Randomized Phase III Breast Cancer Clinical Trials.,"Male breast cancer treatment regimens are often extrapolated from female-based studies because of a paucity of literature analyzing male breast cancer. Using ClinicalTrials.gov, we analyzed breast cancer randomized clinical trials (RCTs) to determine which factors were associated with male-gender inclusion. Of 131 breast cancer RCTs identified, male patients represented 0.087% of the total study population, which is significantly less than the proportion of male patients with breast cancer in the U.S. (0.95%; p < .001). Twenty-seven trials included male patients (20.6%). Lower rates of male inclusion were seen in trials that randomized or mandated hormone therapy as part of the trial protocol compared with trials that did not randomize or mandate endocrine therapy (2.5% vs. 28.6% male inclusion; p < .001). It is imperative for breast cancer clinical trials to include men when allowable in order to improve generalizability and treatment decisions in male patients with breast cancer.",2020,Lower rates of male inclusion were seen in trials that randomized or mandated hormone therapy as part of the trial protocol compared with trials that did not randomize or mandate endocrine therapy (2.5% vs. 30.5% male inclusion; p < .001).,"['male patients with breast cancer', 'Twenty-seven trials included male patients (20.6']",[],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],[],131.0,0.0449363,Lower rates of male inclusion were seen in trials that randomized or mandated hormone therapy as part of the trial protocol compared with trials that did not randomize or mandate endocrine therapy (2.5% vs. 30.5% male inclusion; p < .001).,"[{'ForeName': 'Kelsey L', 'Initials': 'KL', 'LastName': 'Corrigan', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Walker', 'Initials': 'W', 'LastName': 'Mainwaring', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Austin B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'Health Science Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Lin', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Jethanandani', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Espinoza', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Piotrowski', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Fuller', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Stauder', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Simona F', 'Initials': 'SF', 'LastName': 'Shaitelman', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Perkins', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Woodward', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Giordano', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}, {'ForeName': 'Ethan B', 'Initials': 'EB', 'LastName': 'Ludmir', 'Affiliation': 'MD Anderson Cancer Center, McGovern Medical School, University of Texas, Houston, Texas, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0871'] 586,32089329,"Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil ☆ .","PURPOSE Many patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients who require multiple medications, but the number of fixed combinations combining 3 complementary IOP-lowering agents remains limited. This study assessed the efficacy and safety of a triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), compared with a dual fixed combination (DFC) of brimonidine 0.2%/timolol 0.5%. METHODS Patients with a baseline IOP of 23-34 mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study. After washout of previous treatment (if applicable), patients were randomized to receive TFC or DFC twice daily in each eye for 3 months. The primary efficacy variable was the change from baseline in mean IOP in the worse eye at week 12 in the modified intent-to-treat (mITT) population. TFC was superior to DFC if the treatment difference (TFC - DFC) favored TFC at week 12 (P ≤ 0.05; 2-sample t test). Secondary and sensitivity analyses were also performed. Safety, including adverse events, was assessed at all visits. FINDINGS The mITT/safety population included 185 patients (TFC, n = 90; DFC, n = 95). TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22). While treatment-related conjunctival hyperemia was more frequent with TFC than with DFC (47.8% vs 23.2%; P < 0.001), consistent with the additional presence of bimatoprost in TFC, most cases were mild and the numbers of patient discontinuations at week 12 were similar between the TFC and DFC groups (11 [12.2%] vs 7 [7.4%] patients; P = 0.266). No unexpected adverse events were reported. IMPLICATIONS Compared with DFC, TFC provided superior IOP lowering throughout the primary efficacy period. An acceptable tolerability profile was observed through 12 months of use of TFC, offering an effective therapeutic option in patients with POAG or OHT who require multiple medications to control their IOP. Additional studies are required for the assessment of the long-term effects of TFC. ClinicalTrials.gov identifier: NCT01217606.",2020,"TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22).","['patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT', 'patients who require multiple medications', 'patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP', 'Glaucoma', '185 patients (TFC, n\xa0=\xa090; DFC, n\xa0=\xa095', 'Patients with a baseline IOP of 23-34\xa0mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study', 'patients with POAG or OHT who require multiple medications to control their IOP']","['TFC', 'Fixed-combination ophthalmic solutions', 'triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution', 'brimonidine 0.2%/timolol 0.5', 'DFC, TFC', 'TFC or DFC', 'Brimonidine/Timolol']","['mean IOP', 'efficacy and safety', 'acceptable tolerability profile', 'TFC superiority', 'numbers of patient discontinuations', 'adverse events', 'conjunctival hyperemia', 'Safety, including adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C1563133', 'cui_str': 'brimonidine / Timolol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",185.0,0.204619,"TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22).","[{'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Hospital São Paulo, Federal University of São Paulo, São Paulo, Brazil. Electronic address: prof.belfort@clinicabelfort.com.br.'}, {'ForeName': 'Jayter Silva', 'Initials': 'JS', 'LastName': 'Paula', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Medical School, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Marcelo Jordão', 'Initials': 'MJ', 'LastName': 'Lopes Silva', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Medical School, Universidade de São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Della Paolera', 'Affiliation': 'Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Margot L', 'Initials': 'ML', 'LastName': 'Goodkin', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.12.008'] 587,32200381,The Effect of Moderate Weight Loss on a Non-Invasive Biomarker of Liver Fibrosis: A Randomised Controlled Trial.,"BACKGROUND Referral to weight loss programmes is the only effective treatment for non-alcoholic fatty liver disease (NAFLD). Clinicians should advise weight loss and screen for liver fibrosis using the Enhanced Liver Fibrosis (ELF) score. AIM To examine if the ELF score changes with weight loss. DESIGN AND SETTING Randomised controlled trial (ISRCTN85485463) in UK primary care during 2007-2008. METHOD Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease were randomised to attend a community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse (n = 28). Weight and the ELF score were measured at baseline and 1 year. Analysis of covariance examined mean changes in the ELF score between groups and its relationship with weight loss. RESULTS Mean (SD) BMI was 31.10 kg/m2 (2.55) with evidence of moderate levels of liver fibrosis at baseline (mean ELF score: 8.93 [0.99]). There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30). Mean weight loss in the whole cohort was 7.8% (5.9). There was no evidence of an association between weight change and change in ELF; the coefficient for a 5% weight loss was -0.15 (95% CI: -0.30 to 0.0002). CONCLUSION We found no evidence that the ELF score changed meaningfully following moderate weight loss. Clinicians should not use the ELF score to measure improvements in NAFLD fibrosis following weight loss programmes.",2020,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","['Liver Fibrosis', 'Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease']",['community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse'],"['Mean (SD) BMI', 'weight loss', 'ELF score', 'liver fibrosis', 'Weight and the ELF score', 'weight change and change in ELF', 'Mean weight loss']","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0843843,"There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30).","[{'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Koutoukidis', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, dimitrios.koutoukidis@phc.ox.ac.uk.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000505667'] 588,32205194,Impact of a simulation-based ergonomics training curriculum on work-related musculoskeletal injury risk in colonoscopy.,"BACKGROUND AND AIMS Endoscopists are at risk of developing musculoskeletal injuries (MSIs), and few receive training on ergonomics. The aim of this study was to determine the impact of a simulation-based ergonomics training curriculum (ETC) on work-related MSI risk during clinical colonoscopy. METHODS Novice endoscopists underwent a simulation-based ETC and were compared with an historical control group who received simulation-based training without ergonomics training. The ETC included a didactic lecture and video on ergonomics in colonoscopy, feedback from supervisors on ergonomics, and an ergonomics checklist to augment feedback and promote self-reflection. Participants were assessed using the rapid entire body assessment (REBA) and rapid upper limb assessment (RULA). The primary outcome was participants' REBA scores during 2 clinical colonoscopies 4 to 6 weeks after training. RESULTS In clinical colonoscopy, the ETC group had superior REBA scores (clinical procedure 1: median score, 6 vs 11; P < .001; clinical procedure 2: median score, 6 vs 10; P < .001). In a simulated colonoscopy, the ETC group did not have significantly different REBA or RULA scores between baseline, immediately after training, and 4 to 6 weeks after (REBA: median scores of 5, 5, and 5, respectively; P > .05; RULA: median scores of 6, 6, and 6, respectively; P > .05). The control group had worsening REBA and RULA scores during the study timeline (REBA: median scores of 5 at baseline, 9 immediately after training, and 9 at 4-6 weeks after training; P < .001; RULA: median scores of 6, 7, and 7, respectively; P = .04) during simulated procedures. CONCLUSIONS A simulation-based ETC is associated with reduced risk of MSI during endoscopy. Although the REBA score was improved, the intervention group was still within the medium-risk range.",2020,"In simulated colonoscopy, the ETC group did not have significantly different REBA or RULA scores between baseline, immediately after training, and 4 to 6 weeks after (REBA: Md=5 at baseline, 5 at immediately after training, 5 at 4 to 6 weeks after training, p>0.05; RULA: Md=6, 6, 6, p>0.05).",['work-related musculoskeletal injury risk in colonoscopy'],"['simulation-based ergonomics training curriculum (ETC', 'simulation-based ergonomic training curriculum', 'RULA', 'historical control group who received simulation-based training without ergonomics training', 'didactic lecture and video on ergonomics in colonoscopy, feedback from supervisors on ergonomics, and an ergonomics checklist to augment feedback and promote self-reflection']","['REBA score', 'worsening REBA and RULA scores', 'Rapid Entire Body Assessment (REBA) and Rapid Upper Limb Assessment (RULA', 'REBA or RULA scores', 'superior REBA scores', 'REBA scores']","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0403172', 'cui_str': 'Supervisor (occupation)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",,0.0661829,"In simulated colonoscopy, the ETC group did not have significantly different REBA or RULA scores between baseline, immediately after training, and 4 to 6 weeks after (REBA: Md=5 at baseline, 5 at immediately after training, 5 at 4 to 6 weeks after training, p>0.05; RULA: Md=6, 6, 6, p>0.05).","[{'ForeName': 'Rishad', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Scaffidi', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Satchwell', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nikko', 'Initials': 'N', 'LastName': 'Gimpaya', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Woojin', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Genis', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tham', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Saperia', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Mazroui', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Catharine M', 'Initials': 'CM', 'LastName': 'Walsh', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Learning Institute and Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada; The Wilson Centre, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Samir C', 'Initials': 'SC', 'LastName': 'Grover', 'Affiliation': ""Division of Gastroenterology, St Michael's Hospital, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.03.3754'] 589,32057673,Replacing HMG/FSH by low-dose HCG to complete corifollitropin alfa stimulation reduces cost per clinical pregnancy: a randomized pragmatic trial.,"RESEARCH QUESTION The cost of IVF treatment remains high, among other factors because of the medication needed for ovarian stimulation. This study investigated the effect of using low-dose human chorionic gonadotrophin (HCG) for the second phase of follicular maturation after corifollitropin alfa induction, to replace the more expensive, either recombinant or human menopausal gonadotrophin (HMG), on the cost of ovarian stimulation. DESIGN One hundred and five patients were randomly divided into two groups: patients in the HCG group (n = 50) received low-dose HCG from Day 7 until the diameter of at least three follicles reached 17 mm or more, while patients in the FSH group (n = 55) received conventional ovarian stimulation with highly purified HMG injections. RESULTS The clinical pregnancy rate in the HCG group was 38% higher than in the FSH group (number needed to treat, NNT = 13). The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group. Hence, the cost of ovarian stimulation medication to obtain 10 pregnancies using the conventional FSH protocol is sufficient to attain 18 pregnancies when applying the low-dose HCG protocol. CONCLUSION This study provides evidence that using HCG instead of HMG/FSH for ovarian stimulation results in a significant reduction in the cost of IVF with, at least, an equivalent pregnancy rate.",2020,The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group.,['One hundred and five patients'],"['HCG', 'low-dose HCG', 'FSH', 'recombinant or human menopausal gonadotrophin (HMG', 'conventional FSH protocol', 'low-dose human chorionic gonadotrophin (HCG', 'conventional ovarian stimulation with highly purified HMG injections']","['cost of IVF', 'cost per clinical pregnancy', 'cost per pregnancy needed for ovarian stimulation', 'clinical pregnancy rate']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",105.0,0.0762078,The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group.,"[{'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Decleer', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium; IVF Center, AZ Jan Palfijn Gent, Watersportlaan 5, Gent 9000, Belgium. Electronic address: dokter@dokterdecleer.com.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Comhaire', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Balduyck', 'Affiliation': 'KU Leuven, Oude Markt 13, Leuven 3000, Belgium.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ameye', 'Affiliation': 'KU Leuven, Oude Markt 13, Leuven 3000, Belgium.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Osmanagaoglu', 'Affiliation': 'IVF Center, AZ Jan Palfijn Gent, Watersportlaan 5, Gent 9000, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Devroey', 'Affiliation': 'Fertility Clinic, Weststraat 16-18, Aalter 9880, Belgium; Center for Reproductive Medicine, UZ Brussel, Laarbeeklaan 101, Jette 1090, Belgium.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.10.008'] 590,31095287,A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study.,"BACKGROUND Combining immune-checkpoint inhibitors with chemotherapy yielded an increased response rates in patients with metastatic triple-negative breast cancer (TNBC). Therefore, we evaluated the addition of durvalumab to standard neoadjuvant chemotherapy (NACT) in primary TNBC. PATIENTS AND METHODS GeparNuevo is a randomised phase II double-blind placebo-controlled study randomising patients with TNBC to durvalumab or placebo given every 4 weeks in addition to nab-paclitaxel followed by standard EC. In the window-phase durvalumab/placebo alone was given 2 weeks before start of nab-paclitaxel. Randomisation was stratified by stromal tumour-infiltrating lymphocyte (sTILs). Patients with primary cT1b-cT4a-d disease, centrally confirmed TNBC and sTILs were included. Primary objective was pathological complete response (pCR) (ypT0 ypN0). RESULTS A total of 174 patients were randomised, 117 participated in the window-phase. Median age was 49.5 years (range 23-76); 47 patients (27%) were younger than 40 years; 113 (65%) had stage ≥IIA disease, 25 (14%) high sTILs, 138 of 158 (87%) were PD-L1-positive. pCR rate with durvalumab was 53.4% (95% CI 42.5% to 61.4%) versus placebo 44.2% (95% CI 33.5% to 55.3%; unadjusted continuity corrected χ2P = 0.287), corresponding to OR = 1.45 (95% CI 0.80-2.63, unadjusted Wald P = 0.224). Durvalumab effect was seen only in the window cohort (pCR 61.0% versus 41.4%, OR = 2.22, 95% CI 1.06-4.64, P = 0.035; interaction P = 0.048). In both arms, significantly increased pCR (P < 0.01) were observed with higher sTILs. There was a trend for increased pCR rates in PD-L1-positive tumours, which was significant for PD-L1-tumour cell in durvalumab (P = 0.045) and for PD-L1-immune cell in placebo arm (P = 0.040). The most common immune-related adverse events were thyroid dysfunction any grade in 47%. CONCLUSIONS Our results suggest that the addition of durvalumab to anthracycline-/taxane-based NACT increases pCR rate particularly in patients treated with durvalumab alone before start of chemotherapy. TRIAL REGISTRATION ClinicalTrials.gov number: NCT02685059.",2019,"rate with durvalumab was 53.4% (95%CI 42.5%-61.4%) vs placebo 44.2% (95%CI 33.5%-55.3%; unadjusted continuity corrected χ2P=0.287), corresponding to OR=1.45 (95%CI 0.80-2.63, unadjusted Wald P=0.224).","['controlled study randomising patients with TNBC to', '174 patients were randomised, 117 participated in the window-phase', 'Patients with primary cT1b-cT4a-d disease, centrally confirmed TNBC and sTILs were included', 'Median age was 49.5 years (range 23-76); 47 patients (27%) were younger than 40 years; 113 (65%) had stage ≥IIA disease, 25 (14', 'patients with metastatic triple-negative breast cancer (TNBC']","['durvalumab to standard neoadjuvant chemotherapy (NACT', 'placebo', 'anthracycline/taxane based NACT', 'nab-paclitaxel followed by standard EC', 'durvalumab or placebo', 'durvalumab', 'pCR', 'anthracycline taxane-based neoadjuvant therapy']","['pCR rates', 'pCR (ypT0 ypN0', 'PD-L1-immune cell', 'Durvalumab effect', 'pCR rate', 'response rates', 'rate with durvalumab', 'PD-L1-tumour-cell in durvalumab', 'pCR']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}]",174.0,0.714835,"rate with durvalumab was 53.4% (95%CI 42.5%-61.4%) vs placebo 44.2% (95%CI 33.5%-55.3%; unadjusted continuity corrected χ2P=0.287), corresponding to OR=1.45 (95%CI 0.80-2.63, unadjusted Wald P=0.224).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg; Oncological Practice Bethanien, Cancer Center Frankfurt Northeast, Frankfurt am Main. Electronic address: sibylle.loibl@gbg.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'HELIOS Klinikum Berlin-Buch, Berlin.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burchardi', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Brustzentrum, Universitätsfrauenklinik Ulm, Ulm.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin; Berlin Institute of Health (BIH), Berlin.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Gynäkologie mit Brustzentrum, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitätsfrauenklinik Tübingen, Tübingen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Oncological Practice Bethanien, Cancer Center Frankfurt Northeast, Frankfurt am Main.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum München Frauenklinik, München.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Neuss.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': 'Medical Center, Luisenkrankenhaus Düsseldorf, Düsseldorf.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Brustzentrum, Sana-Klinikum Offenbach, Offenbach.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thomalla', 'Affiliation': 'Praxisklinik für Hämatologie und Onkologie Koblenz, Koblenz.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Breast Unit, Kliniken Essen-Mitte, Essen.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rautenberg', 'Affiliation': 'Klinik für Frauenheilkunde, Universitätsklinikum Freiburg, Freiburg.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Brustzentrum, Universitätsklinikum Erlangen, Erlangen.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Hereditary Breast and Ovarian Cancer, University Hospital Cologne, Cologne.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz158'] 591,31132094,Thrombosis as a treatment complication in Hodgkin lymphoma patients: a comprehensive analysis of three prospective randomized German Hodgkin Study Group (GHSG) trials.,"BACKGROUND The prognosis of Hodgkin lymphoma (HL) is excellent rendering research into treatment complications highly important. An important complication of cancer and its treatment is thrombosis. Thrombotic events are regularly observed in HL patients but precise information on incidence and risk factors is lacking and the value of prophylactic anticoagulation unclear. PATIENTS AND METHODS Thus, we comprehensively studied thrombotic events in 5773 patients from the German Hodgkin Study Group (GHSG) HD13-15 trials in early-favorable, intermediate and advanced HL. We estimated the incidence of and identified risk factors for thrombotic events. Additionally, we provide detailed data on the time course and characteristics of thrombotic events. RESULTS A total of 193 thrombotic events occurred for an incidence of 3.3%. Out of these, 175 (90.7%) were venous thromboses, 3 (1.5%) newly emerging post-thrombotic syndromes and 15 (7.8%) arterial thromboses. There were 11 (0.7%) events in early-favorable, 27 (1.3%) in early-unfavorable and 155 (7.3%) in advanced patients, the latter incidence being significantly higher (P < 0.001). The most common locations were deep vein thrombosis of the arm (46.3%) and leg (24.6%). Most venous thrombotic events occurred during chemotherapy (78.9%). We observed 59 (30.6%) catheter-associated events and a descriptively increased risk of venous thrombotic events in patients with oral contraception use during treatment (6.8% versus 3.9%). In advanced HL, the incidence of venous thrombotic events was increased upon treatment with BEACOPP-14 (9.4%, P = 0.0079) compared with 5.1% with 6×BEACOPPesc and 5.7% with 8×BEACOPPesc. Among commonly applied risk factors, including the Khorana score, only age and smoking were prognostic. CONCLUSIONS The incidence of thrombotic events in advanced stage HL is comparable to other high-risk cancer patients, especially if treated with dose-dense regimens. Additional risk factors are higher age and smoking. Selected HL patients could benefit from prophylactic anticoagulation, however, further interventional studies are needed before general recommendations can be made.",2019,The most common locations were deep vein thrombosis of the arm (46.3%) and leg (24.6%).,"['5,773 patients from the GHSG HD13-15 trials in early-favorable, intermediate and advanced HL', 'Hodgkin lymphoma patients']",[],"['thrombotic events', 'incidence of venous thrombotic events', 'venous thromboses', 'risk of venous thrombotic events', 'venous thrombotic events', 'Thrombotic events', 'arterial thromboses', 'deep vein thrombosis', '193 thrombotic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]",[],"[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",,0.0331589,The most common locations were deep vein thrombosis of the arm (46.3%) and leg (24.6%).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Borchmann', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG; Faculty of Medicine, Center for Molecular Medicine, University Hospital of Cologne, University of Cologne, Cologne, Germany; Faculty of Medicine, Else Kröner Forschungskolleg Clonal Evolution in Cancer, University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hude', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG; Division of Hematology, Department of Internal Medicine, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'Faculty of Medicine, Department I of Internal Medicine, GHSG. Electronic address: a.engert@uni-koeln.de.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz168'] 592,31147675,"FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer.","BACKGROUND This hypothesis-generating trial evaluated neoadjuvant ipatasertib-paclitaxel for early triple-negative breast cancer (TNBC). PATIENTS AND METHODS In this randomized phase II trial, patients with early TNBC (T ≥ 1.5 cm, N0-2) were randomized 1 : 1 to receive weekly paclitaxel 80 mg/m2 with ipatasertib 400 mg or placebo (days 1-21 every 28 days) for 12 weeks before surgery. Co-primary end points were pathologic complete response (pCR) rate (ypT0/TisN0) in the intention-to-treat (ITT) and immunohistochemistry phosphatase and tensin homolog (PTEN)-low populations. Secondary end points included pCR rate in patients with PIK3CA/AKT1/PTEN-altered tumors and pre-surgery response rates by magnetic resonance imaging (MRI). RESULTS pCR rates with ipatasertib versus placebo were 17% versus 13%, respectively, in the ITT population (N = 151), 16% versus 13% in the immunohistochemistry PTEN-low population (N = 35), and 18% versus 12% in the PIK3CA/AKT1/PTEN-altered subgroup (N = 62). Rates of overall and complete response (CR) by MRI favored ipatasertib in all three populations (CR rate 39% versus 9% in the PIK3CA/AKT1/PTEN-altered subgroup). Ipatasertib was associated with more grade ≥3 adverse events (32% versus 16% with placebo), especially diarrhea (17% versus 1%). Higher cycle 1 day 8 (C1D8) immune score was significantly associated with better response only in placebo-treated patients. All ipatasertib-treated patients with low immune scores and a CR had PIK3CA/AKT1/PTEN-altered tumors. CONCLUSIONS Adding ipatasertib to 12 weeks of paclitaxel for early TNBC did not clinically or statistically significantly increase pCR rate, although overall response rate by MRI was numerically higher with ipatasertib. The antitumor effect of ipatasertib was most pronounced in biomarker-selected patients. Safety was consistent with prior experience of ipatasertib-paclitaxel. A T-cell-rich environment at C1D8 had a stronger association with improved outcomes in paclitaxel-treated patients than seen for baseline tumor-infiltrating lymphocytes. This dependency may be overcome with the addition of AKT inhibition, especially in patients with PIK3CA/AKT1/PTEN-altered tumors. CLINICALTRIALS.GOV NCT02301988.",2019,"Adding ipatasertib to 12 weeks of paclitaxel for early TNBC did not clinically or statistically significantly increase pCR rate, although overall response rate by MRI was numerically higher with ipatasertib.","['patients with early TNBC (T\u2009≥\u20091.5\u2009cm, N0-2', 'early triple-negative breast cancer', 'patients with PIK3CA/AKT1/PTEN-altered tumors']","['placebo', 'paclitaxel 80\u2009mg/m2 with ipatasertib 400\u2009mg or placebo', 'neoadjuvant ipatasertib-paclitaxel', 'paclitaxel', 'neoadjuvant ipatasertib plus paclitaxel']","['Rates of overall and complete response (CR', 'pCR rates', 'grade ≥3 adverse events', 'pathologic complete response (pCR) rate (ypT0/TisN0', 'pCR rate', 'Higher cycle 1\u2009day 8 (C1D8) immune score', 'pCR rate in patients with PIK3CA/AKT1/PTEN-altered tumors and pre-surgery response rates by magnetic resonance imaging (MRI', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.471259,"Adding ipatasertib to 12 weeks of paclitaxel for early TNBC did not clinically or statistically significantly increase pCR rate, although overall response rate by MRI was numerically higher with ipatasertib.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona; Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona; SOLTI Breast Cancer Research Group, Barcelona. Electronic address: moliveira@vhio.net.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona; Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona; SOLTI Breast Cancer Research Group, Barcelona.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': 'Molecular Oncology Group, VHIO, Barcelona.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Calvo', 'Affiliation': 'Breast Cancer Unit, Centro Integral Oncologico Clara Campal (CIOCC), Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Andersen', 'Affiliation': 'Medical Oncology and Hematology, Compass Oncology and US Oncology, Portland, USA.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Passos-Coelho', 'Affiliation': 'Oncology Department, Hospital Beatriz Angelo, Loures, Portugal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gil Gil', 'Affiliation': ""SOLTI Breast Cancer Research Group, Barcelona; Medical Oncology Service, Institut Català d'Oncologia, L'Hospitalet, Barcelona; Institut d'Investigació Biomédica de Bellvitge (IDIBELL), Barcelona.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Hospital Clinico Universitario, Valencia, Spain.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology Cancer Center, US Oncology, Austin, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona; Medical Oncology Department, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'de la Peña', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Product Development Oncology, Genentech Inc., South San Francisco.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wongchenko', 'Affiliation': 'Oncology Biomarker Department, Genentech Inc., South San Francisco.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Oncology Biomarker Department, Genentech Inc., South San Francisco.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Singel', 'Affiliation': 'Product Development Oncology, Genentech Inc., South San Francisco.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Isakoff', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital Cancer Center, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz177'] 593,32205834,Resistance Exercise Order Does Not Affect the Magnitude and Duration of Postexercise Blood Pressure in Older Women.,"Tomeleri, CM, Nunes, JP, Souza, MF, Gerage, AM, Marcori, A, Iarosz, KC, Cardoso-Júnior, CG, and Cyrino, ES. Resistance exercise order does not affect the magnitude and duration of postexercise blood pressure in older women. J Strength Cond Res 34(4): 1062-1070, 2020-The aim of this study was to compare the effects of 2 resistance exercise order on postexercise blood pressure (BP) in trained nonhypertensive older women. Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm) performed 2 sessions with 8 exercises (3 sets of 8-12 repetitions) in distinct orders (from multi- to single-joint exercises [MS] or from single- to multijoint exercises [SM]) and a control session (CS), without exercise. Blood pressure and heart rate (HR) were obtained pre- and postsessions (60 minutes). Postexercise hypotension was observed for systolic BP (SBP) and mean BP in both the MS session (SBP: -6.9 mm Hg, mean BP: -3.3 mm Hg, p ≤ 0.05) and SM session (SBP: -4.6 mm Hg; mean BP: -1.1 mm Hg). Postexercise HR was higher than presession values until 30 minutes of recovery in both training sessions. Furthermore, SBP and mean BP, and HR were lower than the values obtained in the CS (30-60 minutes and 0 minutes, respectively; p ≤ 0.05). There were no differences between the SM and MS sessions in any variable or at any moment. In conclusion, resistance exercise order does not interfere in the magnitude and duration of postexercise hypotension in trained nonhypertensive older women.",2020,"Postexercise hypotension was observed for systolic BP (SBP) and mean BP in both the MS session (SBP: -6.9 mm Hg, mean BP:","['older women', 'Res 34(4', 'Sixteen women (68.3 ± 3.3 years, 63.5 ± 11.6 kg, 157.5 ± 5.1 cm', 'Older Women', 'trained nonhypertensive older women']","['Resistance exercise', '2 resistance exercise', 'SM session', 'J Strength Cond', 'distinct orders (from multi- to single-joint exercises [MS] or from single- to multijoint exercises [SM]) and a control session (CS), without exercise']","['mean BP', 'postexercise blood pressure (BP', 'systolic BP (SBP) and mean BP', 'Postexercise HR', 'Magnitude and Duration of Postexercise Blood Pressure', 'Furthermore, SBP and mean BP, and HR', 'Blood pressure and heart rate (HR', 'postexercise hypotension', 'Postexercise hypotension', 'postexercise blood pressure', 'Tomeleri, CM, Nunes, JP, Souza, MF, Gerage, AM, Marcori, A, Iarosz, KC, Cardoso-Júnior, CG, and Cyrino, ES']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2936233', 'cui_str': 'Postexercise Hypotension'}]",,0.0261881,"Postexercise hypotension was observed for systolic BP (SBP) and mean BP in both the MS session (SBP: -6.9 mm Hg, mean BP:","[{'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Souza', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Aline Mendes', 'Initials': 'AM', 'LastName': 'Gerage', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Marcori', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Kessi Cassiane', 'Initials': 'KC', 'LastName': 'Iarosz', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Crivaldo Gomes', 'Initials': 'CG', 'LastName': 'Cardoso-Júnior', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002177'] 594,32402495,Non-suturing microvascular anastomosis in maxillofacial reconstruction- a comparative study.,"AIM The aim of the study is to compare the advantages and disadvantages of non-suturing anastomotic methods over conventional microsuturing for microvascular venous anastomosis. MATERIALS AND METHODS All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study. Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study. The patients selected for the study were randomly allocated to five groups of different techniques of venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA)). Intraoperative anastomotic time, flap ischaemic time, patency and leakage were the parameters that were assessed for all five groups. RESULTS 80 Patients were randomly allocated to five groups and each group comprised 16 patients. The mean ischaemic time and standard deviation of Group I and Group II were 256.19 ± 10.622 min and 255.19 ± 11.083 min, and for groups III, IV, and V were 193.38 ± 9.972 min, 139.06 ± 6.413 min, and 139.31 ± 6.364 min respectively (p < 0.001). Mean anastomotic time and standard deviation were 19.813 ± 1.5366 min in Group I and 20.281 ± 1.6514 min in Group II. The non-sutured anastomosis groups III, IV, and V showed a mean anastomotic time of 5.375 ± 0.9876 min, 4.175 ± 0.7664 min, and 3.856 ± 0.867 min respectively (p value < 0.001). In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030). In Groups I and II, 18.8% and 6.3 % of patients respectively had leakage, whereas all patients in Groups III, IV, V had no leakage from the anastomotic site (p value 0.119). CONCLUSION Based on the results of the study, non-suturing techniques should be preferred over microsuturing technique whenever appropriate for venous anastomosis.",2020,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","['Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study', 'All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study', '80 Patients']","['venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA']","['Mean anastomotic time and standard deviation', 'mean ischaemic time and standard deviation', 'mean anastomotic time', 'leakage', 'Intraoperative anastomotic time, flap ischaemic time, patency and leakage', 'delayed patency', 'immediate patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0450432', 'cui_str': 'Venous anastomosis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3665740', 'cui_str': 'Vascular anastomosis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",80.0,0.0156835,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","[{'ForeName': 'Surya Kiran', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: mudigondasuryakiran@gmail.com.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Murugan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, 600077, India. Electronic address: drmsenthilmurugan@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Velavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: drvelavan@gmail.com.'}, {'ForeName': 'Selvakumar', 'Initials': 'S', 'LastName': 'Thulasiraman', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: selvakumaromfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: kksukanya@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.005'] 595,32402496,Does platelet-rich fibrin increase stability of the maxilla following Le Fort I osteotomy? A single-blind clinical trial study.,"This single-blind clinical trial study aimed to assess the efficacy of platelet-rich fibrin (PRF) in increasing stability following Le Fort I osteotomy for maxillary advancement. Patients who underwent Le Fort I osteotomy for maxillary advancement were assigned randomly into two groups: in group 1 (the study group, n = 22) PRF was placed in the osteotomy sites following fixation, while no PRF was used in group 2 (the control group, n = 22). Lateral cephalograms obtained preoperatively (T0), immediately after surgery (T1), and 1 year after surgery (T2) were compared between the two groups, and the amount of relapse was determined. The amount of maxillary change (relapse) at the A point in relation to the x-axis was 0.45 ± 0.67 mm in group 1 and 1.86 ± 0.56 mm in group 2. There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001). The mean maxillary change (relapse) in relation to the y-axis was 0.77 ± 1.15 mm in group 1 and 2.25 ± 1.22 mm in group 2. Analysis of the data demonstrated a significant difference in mean relapse in relation to the y-axis between the two groups (p < 0.001). PRF may enhance the stability of the maxilla following Le Fort I osteotomy. Based on the results of this study the administration of PRF should be considered whenever possible.",2020,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"['I osteotomy for maxillary advancement', 'Patients who underwent Le Fort']","['PRF', 'platelet-rich fibrin (PRF', 'PRF was placed in the osteotomy sites following fixation, while no PRF']","['amount of maxillary change (relapse', 'mean relapse', 'mean maxillary change (relapse']","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.034354,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mirmohammad Sadeghi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Bakhshaei', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Bakhshaei.pedram@gmail.com.'}, {'ForeName': 'Birkan Taha', 'Initials': 'BT', 'LastName': 'Ozkan', 'Affiliation': 'Oral and Maxillofacial Surgery, Toros University, Institute of Health Science, Toros, Turkey.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.007'] 596,32402523,Treatment Adequacy and Adherence as Predictors of Depression Response in Primary Care.,"OBJECTIVE Primary care is the de facto mental health system in the United States where physicians treat large numbers of depressed older adults with antidepressant medication. This study aimed to examine whether antidepressant dosage adequacy and patient adherence are associated with depression response among middle-aged and older adults prescribed with antidepressants by their primary care provider. DESIGN A secondary analysis was conducted on a sample drawn from a randomized controlled trial comparing Treatment as Usual to Treatment Initiation Program, an adherence intervention. Treatment Initiation Program improved adherence but not depression compared to Treatment as Usual (Sirey et al., 2017). For this analysis, we examined dosing adequacy and adherence at 6 and 12 weeks as predictors of depression response in both groups at 12 and 24 weeks. SETTING Primary care practices. PARTICIPANTS One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider. MEASUREMENTS Depression response was defined as 50% reduction on the Hamilton Rating Scale for Depression. Adherence was defined as taking 80% of doses at follow-up interviews (6 and 12 weeks). Patient-reported dosage and duration of antidepressant therapy was collected using the Composite Antidepressant Score (adequacy score of >3) at follow-up. RESULTS Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). CONCLUSION As physicians prescribe antidepressants to the diverse group of adults seen in primary care, special attention to patients' views and approach to adherence may improve depression outcomes.",2020,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). ","['middle-aged and older adults prescribed with antidepressants by their primary care provider', 'One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider', 'depressed older adults with antidepressant medication', 'Primary care practices']",[],"['Greater adherence', 'Depression response', 'Hamilton Rating Scale for Depression', 'depression response', 'Adherence']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",187.0,0.0742356,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). ","[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA). Electronic address: jsirey@med.cornell.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Kales', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California at Davis (HCK).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.014'] 597,32182241,"Effectiveness of a culturally appropriate nutrition educational intervention delivered through health services to improve growth and complementary feeding of infants: A quasi-experimental study from Chandigarh, India.","BACKGROUND Malnutrition is a major public health problem in India, especially among urban poor children. The objective of the study was to determine the effectiveness of a culturally appropriate nutrition educational intervention that can be delivered through health services and digitized child undernutrition tracking module for health workers to improve complementary feeding of infants of age six months to 12 months in Chandigarh, North India, to prevent malnutrition in infants. METHODS A quasi-experimental study was conducted in a non-randomized intervention (Burail) and control area (Maloya) among a vulnerable population in Chandigarh, North India. The mother-infant dyads (MIDs) in the intervention group(n = 202) received culturally appropriate nutrition educational intervention, were supported individually by trained health workers in infant feeding and followed up for six months. Health workers were monitored through a digitized tracking module. The MIDs in the control group (n = 202) received routine care under the national health program. The mean (±S.D.) age of infants in the intervention and control group was 5.4 (±0.8) months and 5.5 (±0.7) months, respectively. The data was collected using a pre-tested semi-structured questionnaire and anthropometry of infants at baseline and end line. The primary outcome was a mean change in weight. The effectiveness of the intervention was measured by conducting the difference in difference (DID) analysis in mean change in weight between intervention and control group. RESULT At baseline, the mean (±S.D.) weight of infants was 6.6(±0.64) kg and 6.6 (±0.52) kg in the intervention and control group. The mean (±S.D.) length of infants was 64.3 (±2.0) cm in the intervention group and 65.1 (±1.7) cm in the control group. Out of 404, 190 and 191 MIDs in the intervention and control group completed the study, respectively. A significantly higher number of infants in the intervention group were started on complementary feeding at six months of age (72.6% versus45.5%, p<0.01) and received foods having thick consistency (82.1% versus 41.9%, p<-0.01). There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline. Also, there was significant decline in the proportion of undernourished (10% versus18.8%, OR = 0.47, p = 0.01) and wasted infants (7.3% versus15.7%, OR = 0.42, p = 0.01) in the intervention group. CONCLUSION Community-based nutrition educational intervention delivered through the routine health services and digitized tracking of malnourished children can effectively improve the complementary feeding and growth of children six months to one year among vulnerable populations.",2020,"There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline.","['A quasi-experimental study was conducted in a non-randomized intervention (Burail) and control area (Maloya) among a vulnerable population in Chandigarh, North India', 'urban poor children', 'malnourished children', 'infants of age six months to 12 months in Chandigarh, North India, to prevent malnutrition in infants', 'infants']","['culturally appropriate nutrition educational intervention', 'Community-based nutrition educational intervention', 'routine care under the national health program']","['mean (±S.D.) length of infants', 'proportion of undernourished', 'length gain', 'weight gain', 'mean change in weight']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1257752', 'cui_str': 'Infant Malnutrition'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0027459', 'cui_str': 'National Health Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0381763,"There was significant weight gain in intervention group infants (DID means = 0.27 kg, p<0.01) and length gain (DID means = 0.9 cm, p<0.01) from the baseline.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Mutyalamma', 'Initials': 'M', 'LastName': 'Gorle', 'Affiliation': 'Dietetics Department, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",PloS one,['10.1371/journal.pone.0229755'] 598,32115349,Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials.,"BACKGROUND Preclinical data have shown that proton pump inhibitors (PPI) can modulate the microbiome, and single-arm studies suggested that antibiotics (ATB) may decrease the efficacy of immune checkpoint inhibitors (ICI), but randomized controlled trial data are lacking. This pooled analysis evaluated the effect of ATB and PPI on outcome in patients randomized between ICI and chemotherapy. PATIENTS AND METHODS This retrospective analysis used pooled data from the phase II POPLAR (NCT01903993) and phase III OAK (NCT02008227) trials, which included 1512 patients with previously treated non-small-cell lung cancer (NSCLC) randomly assigned to receive atezolizumab (n = 757) or docetaxel (n = 755). The main objective of this analysis was to assess the impact of ATB and PPI use on overall survival (OS) and progression-free survival (PFS). RESULTS A total of 169 (22.3%) patients in the atezolizumab group and 202 (26.8%) in the docetaxel group received ATB, and 234 (30.9%) and 260 (34.4%), respectively, received PPI. Multivariate analysis in all patients revealed that ATB were associated with shorter OS [hazard ratio (HR) 1.20, 95% confidence interval (CI) 1.04-1.39], as was PPI (HR 1.26, 95% CI 1.10-1.44). Within the atezolizumab population, OS was significantly shorter in patients who received ATB (8.5 versus 14.1 months, HR 1.32, 95% CI 1.06-1.63, P = 0.01) or PPI (9.6 versus 14.5 months, HR 1.45, 95% CI 1.20-1.75, P = 0.0001). PPI use was associated with shorter PFS in the atezolizumab population (1.9 versus 2.8 months, HR 1.30, 95% CI 1.10-1.53, P = 0.001). There was no association between ATB and PPI use and PFS or OS within the docetaxel population. CONCLUSION In this unplanned analysis from two randomized trials, data suggest that ATB or PPI use in patients with metastatic NSCLC is associated with poor outcome and may influence the efficacy of ICI.",2020,"PPI use was associated with shorter PFS in the atezolizumab population (1.9 versus 2.8 months, HR 1.30, 95% CI 1.10-1.53, P = 0.001).","['patients randomized between ICI and chemotherapy', 'patients with non-small-cell lung cancer receiving', '1512 patients with previously treated non-small-cell lung cancer (NSCLC', 'patients with metastatic NSCLC']","['chemotherapy and atezolizumab', 'docetaxel', 'ATB and PPI', 'atezolizumab', 'proton pump inhibitors (PPI', 'antibiotics and proton pump inhibitors']","['overall survival (OS) and progression-free survival (PFS', 'ATB and PPI use and PFS or OS', 'shorter OS [hazard ratio (HR', 'PPI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",1512.0,0.366156,"PPI use was associated with shorter PFS in the atezolizumab population (1.9 versus 2.8 months, HR 1.30, 95% CI 1.10-1.53, P = 0.001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chalabi', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: m.chalabi@nki.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cardona', 'Affiliation': 'PD Biometrics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Nagarkar', 'Affiliation': 'Cancer Immunology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dhawahir Scala', 'Affiliation': 'PD Biometrics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'Department of Thoracic Oncology, UC Davis Comprehensive Cancer Center, Sacramento, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rittmeyer', 'Affiliation': 'Department of Thoracic Oncology, Pulmonary Clinic Immenhausen, Immenhausen, Germany.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Cancer Immunology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kok', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Tumor Biology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Herrera', 'Affiliation': 'Immune Oncology Service, Lausanne University Hospital, Ludwig Institute for Cancer Research, Lausanne, Switzerland. Electronic address: Fernanda.Herrera@chuv.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.01.006'] 599,31916303,Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial.,"BACKGROUND AND AIMS Within the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits. DESIGN Cluster-randomized clinical trial. SETTING Twenty-two primary care clinics in South Carolina, USA. PARTICIPANTS Adult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics). MEASUREMENTS The primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline. FINDINGS Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7). CONCLUSION Providing smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.",2020,"FINDINGS Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months (12% vs. 8%; Odds Ratio [OR] = 1.5; 95% Confidence Interval [CI]: 1.0 - 2.4).","['smoking cessation within primary care', '22 primary care clinics in South Carolina, USA', 'Adult smokers (N=1245; 61% female, mean age 50.7, (SD=13.5) both motivated and unmotivated to quit, seen during routine clinical visit']","['nicotine replacement therapy (i.e., provision of NRT starter kits', 'NRT sampling plus standard care (SC', 'nicotine replacement therapy', 'NRT', 'Provider-delivered SC (n=652, 12 clinics) cessation advice, or SC + a two-week supply of both nicotine patch and lozenge, with minimal instructions', 'Nicotine replacement therapy sampling']","['7-day point prevalence smoking abstinence', 'quit attempts, use of stop smoking medications, and smoking abstinence', 'overall rate of quit attempts', 'NRT use and quit attempts', 'rate of quit attempts', 'prevalence abstinence rates']","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",22.0,0.138011,"FINDINGS Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months (12% vs. 8%; Odds Ratio [OR] = 1.5; 95% Confidence Interval [CI]: 1.0 - 2.4).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences,, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'Department of Public Health Sciences,, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': 'Greenville Health System and Care Coordination Institute, Greenville, SC, USA.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Egan', 'Affiliation': 'Greenville Health System and Care Coordination Institute, Greenville, SC, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14953'] 600,30985536,Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial.,"BACKGROUND There is a controversy in the literature whether deep compared with moderate neuromuscular block (NMB) improves surgical conditions for laparoscopic surgery. OBJECTIVES The primary outcome measure was to examine whether switching from moderate to deep NMB improves surgical conditions for laparoscopic surgery in the obese; secondary outcome measures were changes in intra-abdominal pressure, time required to perform the gastrojejunal anastomosis and peri-operative surgical complications. DESIGN A single-centre, randomised controlled study. Each patient was taken as their own control and examined twice: at the first evaluation (E1), all patients had a moderate NMB, thereafter patients were randomised to deep or moderate block and a second evaluation (E2) was performed within 10 min. Patients with excellent rating at E1 were excluded from E2, as their surgical condition could not be further improved. SETTING University Hospital France. PATIENTS Patients undergoing laparoscopic gastric bypass surgery under general anaesthesia were included. Main exclusion criteria were hypersensitivity to the drugs used and absence of written informed consent. INTERVENTIONS According to the group assignment, patients received bolus doses of rocuronium or 0.9% saline. MAIN OUTCOME MEASURES Surgical conditions were assessed with a 4-point rating scale. Intra-operative adverse events were assessed with the Kaafarani-classification and postoperative complications with the Clavien-Dindo classification. RESULTS Eighty-nine patients were initially included and data from 85 could be assessed at E1; surgical rating was excellent in 20, good in 35, acceptable in 18, poor in 12. After excluding those with an excellent rating, the remaining 65 patients were randomly assigned to deep or moderate block. At E2, an improvement of surgical conditions was observed in 29 out of 34 patients with deep block and in four out of 31 with moderate block; P < 0.0001. Poor surgical conditions were more frequently associated with surgical complications (61.5 versus 15.3%; P < 0.001). CONCLUSION Switching from moderate to deep block improves surgical conditions. Poor surgical conditions were associated with a higher incidence of surgical complications. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02118844.",2019,"Poor surgical conditions were more frequently associated with surgical complications (61.5 versus 15.3%; P < 0.001). ","['Eighty-nine patients', 'Patients undergoing laparoscopic gastric bypass surgery under general anaesthesia were included', 'morbid obesity', 'University Hospital France']","['gastric bypass surgery', 'moderate neuromuscular block (NMB', 'rocuronium or 0.9% saline', 'Deep neuromuscular blockade']","['surgical complications', 'surgical conditions', 'changes in intra-abdominal pressure, time required to perform the gastrojejunal anastomosis and peri-operative surgical complications']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]",34.0,0.134069,"Poor surgical conditions were more frequently associated with surgical complications (61.5 versus 15.3%; P < 0.001). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fuchs-Buder', 'Affiliation': 'From the Department of Anesthesiology & Critical Care, Brabois University Hospital, University de Lorraine, CHRU Nancy (TF-B, DS, LH, CM), the Clinical Research Support Facility PARC, Brabois University Hospital (CB), the Multidisciplinary Unit of Bariatric Surgery, UMCO, Brabois University Hospital, University de Lorraine, CHRU Nancy (CN-C, LB), University de Lorraine, INSERM U954, Faculty of Medicine, Nancy, France (LB), and Department of Anesthesiology, Université Libre de Bruxelles, CHU Brugmann, Bruxelles, Belgium (DS).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Schmartz', 'Affiliation': ''}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baumann', 'Affiliation': ''}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Hilt', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Nomine-Criqui', 'Affiliation': ''}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Meistelman', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Brunaud', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000996'] 601,30985540,Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial.,"BACKGROUND Magnesium sulphate is an important adjuvant drug in multimodal anaesthesia. In combination with rocuronium it can enhance neuromuscular blockade (NMB). Limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and the period of no response. OBJECTIVE(S) To determine the role of magnesium sulphate on the duration of rocuronium-induced deep and intense NMB, and the period of no response to nerve stimulation. DESIGN A randomised controlled trial. SETTING A public tertiary care hospital, Rio de Janeiro, Brazil, from February 2017 to March 2018. PATIENTS All patients between 18 and 65 years of age scheduled to undergo elective otorhinolaryngological surgery, with a BMI between 18.5 and 24.9 kg m and an American Society of Anesthesiologists physical status classification of I or II. INTERVENTION(S) Before induction of anaesthesia 60 patients were pretreated with an intravenous infusion of either 100 ml 0.9% saline (saline group), or 60 mg kg magnesium sulphate (magnesium group). After loss of consciousness, a bolus of rocuronium (0.6 mg kg) was administered. Neuromuscular function was measured by TOF-Watch SX monitor. MAIN OUTCOME MEASURES The primary and secondary outcomes were the duration of the period of no response to nerve stimulation and intense and deep NMB, respectively. An additional outcome was the NMB onset time. RESULTS Median [IQR] durations of deep NMB were 20.3 [12.0 to 35.4] and 18.3 [11.2 to 26.3] min in the magnesium and saline groups, respectively (P = 0.18). Median durations of intense NMB were 21.7 [0.0 to 32.2] min and 0.0 [0.0 to 6.2] min (P = 0.001) in the magnesium and saline groups, respectively. Median durations of the period of no response were 40.8 [51.4 to 36.0] min and 28.0 [21.9 to 31.6] min (P = 0.0001) in the magnesium and saline groups, respectively. CONCLUSION Magnesium sulphate increased both the duration of intense NMB and the period of no response. The duration of deep NMB was similar in the magnesium sulphate group and saline group. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02989272.",2019,"The duration of deep NMB was similar in the magnesium sulphate group and saline group. ","['All patients between 18 and 65 years of age scheduled to undergo elective otorhinolaryngological surgery, with a BMI between 18.5 and 24.9\u200akg\u200am and an American Society of Anesthesiologists physical status classification of I or II', 'A public tertiary care hospital, Rio de Janeiro, Brazil, from February 2017 to March 2018']","['intravenous infusion of either 100\u200aml 0.9% saline (saline group), or 60\u200amg\u200akg magnesium sulphate (magnesium group', 'magnesium sulphate', 'Magnesium sulphate', 'rocuronium']","['duration of deep or intense NMB', 'Median durations of intense NMB', 'duration of intense and deep neuromuscular blockade', 'duration of deep NMB', 'neuromuscular blockade (NMB', 'duration of intense NMB', 'Median durations of the period of no response', 'Neuromuscular function', 'Median [IQR] durations of deep NMB', 'NMB onset time', 'duration of the period of no response to nerve stimulation and intense and deep NMB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0038910', 'cui_str': 'Otorhinolaryngological Surgical Procedures'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0445581', 'cui_str': 'Rio (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",60.0,0.414692,"The duration of deep NMB was similar in the magnesium sulphate group and saline group. ","[{'ForeName': 'Angelo J', 'Initials': 'AJ', 'LastName': 'Queiroz Rangel Micuci', 'Affiliation': 'From the Department of Anesthesiology, Bonsucesso Federal Hospital (Hospital Federal de Bonsucesso) (AJQRM, DDB), Department of Surgery, Anaesthesiology, Surgical Sciences Postgraduate Program, Federal University of Rio de Janeiro (Universidade Federal do Rio de Janeiro), Rio de Janeiro, Brazil (NV, PAGF), Department of Anesthesiology Pain Medicine and Procedural Sedation and Analgesia, Martini General Hospital, Groningen, The Netherlands (HDdB) and Department of General and Specialized Surgery, Anaesthesiology, Medical Sciences Postgraduate Program Federal University Fluminense (Universidade Federal Fluminense), Niterói, Brazil (ILC).'}, {'ForeName': 'Nubia', 'Initials': 'N', 'LastName': 'Verçosa', 'Affiliation': ''}, {'ForeName': 'Paulo A G', 'Initials': 'PAG', 'LastName': 'Filho', 'Affiliation': ''}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'de Boer', 'Affiliation': ''}, {'ForeName': 'Daniela D', 'Initials': 'DD', 'LastName': 'Barbosa', 'Affiliation': ''}, {'ForeName': 'Ismar L', 'Initials': 'IL', 'LastName': 'Cavalcanti', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001003'] 602,32402832,Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial.,"BACKGROUND In the present paper, we introduce our experience with the novel method during laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE). METHODS A prospective randomized controlled trial was performed from June 2016 to May 2019. Patients with upper rectal or sigmoid colon cancer were randomized in a 1:1 ratio to the NOSE group and the non-NOSE group. Preoperative and postoperative clinical variables were analyzed and compared between groups. Postoperative pain was analyzed utilizing a visual analog scale. Postoperative overall survival was analyzed using a Kaplan-Meier curve. RESULTS A total of 276 patients were enrolled, of whom 254 were randomly divided into the NOSE group (n = 122) and the conventional laparoscopic group (n = 119). NOSE failed in 22 cases, which were converted to transabdominal specimen extraction. Intention-to-treat analysis was performed, and these 22 cases were included in the NOSE group. The incidence of postoperative complications was significantly lower in the NOSE group (11/122, 9%) than in the non-NOSE group (25/119, 21%). The NOSE group had a longer operation time, less blood loss, and a lower postoperative visual analog scale score than the non-NOSE group. The time for intestinal function recovery (ventilation) and the length of hospital stay were significantly longer in the non-NOSE group. The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group. CONCLUSIONS The novel NOSE method is safe and feasible to use in patients having colorectal cancer. Compared with traditional laparoscopic surgery, the postoperative complication rates of NOSE surgery were lower with an improved short-term clinical recovery.",2020,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group. ","['June 2016 to May 2019', 'patients having colorectal cancer', '22 cases were included in the NOSE group', 'Patients with upper rectal or sigmoid colon cancer', 'A total of 276 patients were enrolled, of whom 254']","['conventional laparoscopic group', 'traditional laparoscopic surgery', 'laparoscopic anterior resection of upper rectal or sigmoid colon cancer by transrectal natural orifice specimen extraction (NOSE', 'Transrectal Natural Orifice Specimen Extraction (NOSE', 'NOSE']","['incidence of postoperative complications', 'longer operation time, less blood loss', 'postoperative complication rates of NOSE surgery', 'time for intestinal function recovery (ventilation) and the length of hospital stay', 'disease-free survival rate', 'postoperative visual analog scale score', 'Postoperative overall survival', 'Postoperative pain']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",276.0,0.0637219,"The Kaplan-Meier survival curve showed no statistically significant difference in the disease-free survival rate between the NOSE group and the non-NOSE group. ","[{'ForeName': 'Zhu-Qing', 'Initials': 'ZQ', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaijing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qixin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuan-Gang', 'Initials': 'CG', 'LastName': 'Fu', 'Affiliation': 'Department of General Surgery and Colorectal Surgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: fugang416@126.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.03.064'] 603,32404353,Costimulation Blockade Disrupts CD4 + T Cell Memory Pathways and Uncouples Their Link to Decline in β-Cell Function in Type 1 Diabetes.,"We previously reported that costimulation blockade by abatacept limits the decline of β-cell function and the frequency of circulating CD4 + central memory T cells (T CM ) (CD45RO + CD62L + ) in new-onset type 1 diabetes. In human subjects receiving placebo, we found a significant association between an increase in CD4 + T CM cells and the decline of β-cell function. To extend and refine these findings, we examined changes in human CD4 + and CD8 + naive and memory T cell subsets at greater resolution using polychromatic flow and mass cytometry. In the placebo group, we successfully reproduced the original finding of a significant association between T CM and β-cell function and extended this to other T cell subsets. Furthermore, we show that abatacept treatment significantly alters the frequencies of a majority of CD4 + conventional and regulatory T cell subsets; in general, Ag-naive subsets increase and Ag-experienced subsets decrease, whereas CD8 + T cell subsets are relatively resistant to drug effects, indicating a lesser reliance on CD28-mediated costimulation. Importantly, abatacept uncouples the relationship between changes in T cell subsets and β-cell function that is a component of the natural history of the disease. Although these data suggest immunological markers for predicting change in β-cell function in type 1 diabetes, the finding that abatacept blunts this relationship renders the biomarkers nonpredictive for this type of therapy. In sum, our findings point to a novel mechanism of action for this successful immunotherapy that may guide other disease-modifying approaches for type 1 diabetes.",2020,"In the placebo group, we successfully reproduced the original finding of a significant association between T CM and β-cell function and extended this to other T cell subsets.",[],['placebo'],"['T CM and β-cell function', 'CD4 + T CM cells and the decline of β-cell function', 'human CD4 + and CD8 + naive and memory T cell subsets', 'frequencies of a majority of CD4 + conventional and regulatory T cell subsets', 'frequency of circulating CD4 + central memory T cells (T CM ) (CD45RO + CD62L + ']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0162833', 'cui_str': 'Lymphocyte antigen CD45RO'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}]",,0.0502345,"In the placebo group, we successfully reproduced the original finding of a significant association between T CM and β-cell function and extended this to other T cell subsets.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichmann', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom; martin.eichmann@kcl.ac.uk.""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Baptista', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': ""Biomedical Research Centre at Guy's and St Thomas' Hospitals and King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Heck', 'Affiliation': ""Biomedical Research Centre at Guy's and St Thomas' Hospitals and King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Peakman', 'Affiliation': ""Peter Gorer Department of Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London SE1 9RT, United Kingdom.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Homer Stryker M.D. School of Medicine, Western Michigan University, Kalamazoo, MI 49008.'}]","Journal of immunology (Baltimore, Md. : 1950)",['10.4049/jimmunol.1901439'] 604,32405474,Listening to music during arteriovenous fistula surgery alleviates anxiety: A randomized single-blind clinical trial.,"BACKGROUND Both end-stage renal disease and being wait-listed for a kidney transplant are anxiety-causing situations. Wait-listed patients usually require arteriovenous fistula surgery for dialysis access. This procedure is performed under local anesthesia. We investigated the effects of music on the anxiety, perceived pain and satisfaction levels of patients who underwent fistula surgery. AIM To investigate the effect of music therapy on anxiety levels and perceived pain of patients undergoing fistula surgery. METHODS Patients who were on a waiting list for kidney transplants and scheduled for fistula surgery were randomized to control and music groups. The music group patients listened to music throughout the fistula surgery. The State-Trait Anxiety Inventory was performed to assess anxiety, additionally visual analog scale was used to evaluate perceived pain, willingness to repeat the procedure and patient satisfaction. Demographic features, comorbidities, surgical history, basic surgical data (location of fistula creation, duration of surgery, incision length) and intra-operative hemodynamic parameters were recorded by an investigator blinded to the study group. An additional trait anxiety assessment was performed following the surgery. RESULTS There was a total of 55 patients included in the study. However, 14 patients did not fulfill the criteria due to requirement of sedation during surgery or uncompleted questionnaires. The remaining 41 patients were included in the analysis. There were 26 males and 15 females. The control and music groups consisted of 20 and 21 patients, respectively. With regard to basic surgical and demographic data, there was no difference between the groups. Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P < 0.05). Postoperative state anxiety levels were significantly lower in the music group. CONCLUSION Music therapy can be a complimentary treatment for patients undergoing fistula surgery. It can reduce anxiety and perceived pain, improve intraoperative hemodynamic parameters and enhance treatment satisfaction, thus may contribute to better compliance of the patients.",2020,Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P < 0.05).,"['Patients who were on a waiting list for kidney transplants and scheduled for fistula surgery', 'patients undergoing fistula surgery', '26 males and 15 females', '55 patients included in the study', 'patients who underwent fistula surgery']","['music therapy', 'Music therapy', 'music group patients listened to music throughout the fistula surgery', 'Listening to music during arteriovenous fistula surgery alleviates anxiety']","['Postoperative state anxiety levels', 'anxiety and perceived pain', 'anxiety, perceived pain and satisfaction levels', 'intra-operative heart rate and blood pressure', 'Overall patient satisfaction', 'Demographic features, comorbidities, surgical history, basic surgical data (location of fistula creation, duration of surgery, incision length) and intra-operative hemodynamic parameters', 'anxiety levels and perceived pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]","[{'cui': 'C0231287', 'cui_str': 'Postoperative state'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",55.0,0.104138,Overall patient satisfaction was significantly higher and intra-operative heart rate and blood pressure were significantly lower in the music group ( P < 0.05).,"[{'ForeName': 'Sanem Guler', 'Initials': 'SG', 'LastName': 'Cimen', 'Affiliation': 'Department of General Surgery, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey. s.cimen@dal.ca.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Oğuz', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Ayse Gokcen', 'Initials': 'AG', 'LastName': 'Gundogmus', 'Affiliation': 'Department of Psychiatry, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Sertac', 'Initials': 'S', 'LastName': 'Cimen', 'Affiliation': 'Department of Urology, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Sandikci', 'Affiliation': 'Department of Urology, Diskapi Research and Traning Hospital, Health Sciences University, Ankara 06110, Turkey.'}, {'ForeName': 'Mehmet Deniz', 'Initials': 'MD', 'LastName': 'Ayli', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Diskapi Research and Training Hospital, Health Sciences University, Ankara 06110, Turkey.'}]",World journal of transplantation,['10.5500/wjt.v10.i4.79'] 605,32200433,Olfactory perception rehabilitation after total laryngectomy (OPRAT): proposal of a new protocol based on training of sensory perception skills.,"PURPOSE We aim to propose a new protocol for olfaction rehabilitation after total laryngectomy based on training of sensory perception levels using the Nasal Airflow-Inducing Maneuver. METHODS This is a randomized clinical trial including patients undergoing total laryngectomy between March 2010 and March 2019. Patients with nasal or oral abnormalities, prior olfaction impairment, a muco-ciliary transport time higher than 30 min, positive history for feeding, and neurological disorders were excluded. Thirty-three patients were enrolled and were randomized into two groups: an Experimental group, submitted to the new protocol (olfactory perception rehabilitation after total laryngectomy-OPRAT) and a Control group that did not receive any treatment. Subjective Olfactometry, Chemosensory Complaints Score, and University of Washington Quality of Life version 4 questionnaires were used to assess the outcomes before and after treatment, and at 3-month, 6-month, and 10-month follow-up. RESULTS Among the 33 patients included (32 men and 1 woman; mean age, 67.94 ± 5.64 years), 17 were subjected to olfaction rehabilitation and 16 did not receive any treatment. At baseline evaluation, there were not significant differences between the two groups. At the end of treatment, the rehabilitated group improved their olfaction capability significantly. Such improvement remained stable over time, and after 10 months, only the Experimental group had significant improvements in all outcome measures. CONCLUSIONS The OPRAT may guarantee excellent results in the short- and long-term time with positive effects on the Quality of Life.",2020,"Such improvement remained stable over time, and after 10 months, only the Experimental group had significant improvements in all outcome measures. ","['33 patients included (32 men and 1 woman; mean age, 67.94\u2009±\u20095.64\xa0years), 17 were subjected to olfaction rehabilitation and 16 did not receive any treatment', 'Thirty-three patients were enrolled', 'Patients with nasal or oral abnormalities, prior olfaction impairment, a muco-ciliary transport time higher than 30 min, positive history for feeding, and neurological disorders were excluded', 'patients undergoing total laryngectomy between March 2010 and March 2019']","['Olfactory perception rehabilitation after total laryngectomy (OPRAT', 'Nasal Airflow-Inducing Maneuver', 'new protocol (olfactory perception rehabilitation after total laryngectomy-OPRAT) and a Control group that did not receive any treatment']","['Quality of Life', 'olfaction capability', 'Subjective Olfactometry, Chemosensory Complaints Score, and']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}]","[{'cui': 'C2350520', 'cui_str': 'Olfactory Perception'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0260239', 'cui_str': 'Olfactometry'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",33.0,0.0158868,"Such improvement remained stable over time, and after 10 months, only the Experimental group had significant improvements in all outcome measures. ","[{'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Longobardi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Parrilla', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Cintio', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Rome, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'De Corso', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maria Elisabetta', 'Initials': 'ME', 'LastName': 'Marenda', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Paludetti', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': ""D'Alatri"", 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy. lucia.dalatri@unicatt.it.'}, {'ForeName': 'Giulio Cesare', 'Initials': 'GC', 'LastName': 'Passali', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCSS, Clinica Di Otorinolaringoiatria, Roma, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05918-8'] 606,31045455,Effects of Arteriovenous Fistula Ligation on Cardiac Structure and Function in Kidney Transplant Recipients.,"BACKGROUND Cardiovascular morbidity and mortality remain high in recipients of a kidney transplant. The persistence of a patent arteriovenous fistula (AVF) after transplantation may contribute to ongoing maladaptive cardiovascular remodeling. The ability to reverse this maladaptive remodeling by ligation of this AVF is unknown. We conducted the first randomized controlled trial to evaluate the effect of AVF ligation on cardiac structure and function in stable kidney transplant recipients. METHODS In this randomized controlled trial, kidney transplant recipients (>12 months after transplantation with stable graft function) were randomized to AVF ligation or no intervention. All participants underwent cardiac magnetic resonance imaging at baseline and at 6 months. The primary outcome was the change in left ventricular (LV) mass. Secondary outcomes included changes in LV volumes, left and right atrial areas, LV ejection fraction, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, cardiac output/index, brachial flows (ipsilateral to AVF), and pulmonary artery velocity. RESULTS A total of 93 patients were screened, of whom 64 met the inclusion criteria and were randomized to the AVF ligation (n=33) or control (n=31) group. Fifty-four participants completed the study: 27 in the AVF ligation group and 27 in the control group. On the second cardiac magnetic resonance scan, a mean decrease of 22.1 g (95% CI, 15.0-29.1) was observed in LV mass in the AVF ligation group compared with a small increase of 1.2 g (95% CI, -4.8 to 7.2) in the control group ( P<0.001). Significant decreases in LV end-diastolic volumes, LV end-systolic volumes, cardiac output, cardiac index, atrial volumes, and NT-proBNP were also seen in the AVF closure group ( P<0.01). No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07). No significant complications were noted after AVF ligation. No changes in estimated glomerular filtration rate or systolic and diastolic blood pressures were observed between cardiac magnetic resonance scans. CONCLUSIONS Elective ligation of patent AVF in adults with stable kidney transplant function resulted in clinically significant reduction of LV myocardial mass. CLINICAL TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry URL: https://www.anzctr.org.au . Unique Identifier: ACTRN12613001302741.",2019,No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07).,"['93 patients were screened, of whom 64 met the inclusion criteria', 'Fifty-four participants completed the study: 27 in the AVF ligation group and 27 in the control group', 'adults with stable kidney transplant function', 'recipients of a kidney transplant', 'stable kidney transplant recipients', 'kidney transplant recipients (>12 months after transplantation with stable graft function', 'n=33) or control (n=31) group', 'Kidney Transplant Recipients']","['Arteriovenous Fistula Ligation', 'AVF ligation or no intervention', 'cardiac magnetic resonance imaging', 'AVF ligation']","['Cardiac Structure and Function', 'pulmonary artery velocity', 'estimated glomerular filtration rate or systolic and diastolic blood pressures', 'LV end-diastolic volumes, LV end-systolic volumes, cardiac output, cardiac index, atrial volumes, and NT-proBNP', 'cardiac structure and function', 'LV mass', 'changes in LV volumes, left and right atrial areas, LV ejection fraction, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, cardiac output/index, brachial flows (ipsilateral to AVF), and pulmonary artery velocity', 'change in left ventricular (LV) mass', 'LV ejection fraction', 'LV myocardial mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0189718', 'cui_str': 'Repair of arteriovenous fistula by suture (procedure)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",93.0,0.220665,No significant changes were observed in LV ejection fraction ( P=0.93) and pulmonary artery velocity ( P=0.07).,"[{'ForeName': 'Nitesh N', 'Initials': 'NN', 'LastName': 'Rao', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Stokes', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Rajwani', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Ullah', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'King', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Macaulay', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Christine H', 'Initials': 'CH', 'LastName': 'Russell', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Olakkengil', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Carroll', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Central Northern Adelaide Renal and Transplantation Service (N.N.R., D.K., E.M., C.H.R., S.O., R.P.C., R.J.F., S.P.M., P.T.C.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Karen S L', 'Initials': 'KSL', 'LastName': 'Teo', 'Affiliation': 'Department of Cardiology (M.B.S., A.R., K.W., K.S.L.T., M.I.W.), Central Adelaide Local Health Network, Australia.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'McDonald', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Worthley', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}, {'ForeName': 'P Toby', 'Initials': 'PT', 'LastName': 'Coates', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Australia (N.N.R., S.U., R.P.C., S.P.M., M.I.W., P.T.C.).'}]",Circulation,['10.1161/CIRCULATIONAHA.118.038505'] 607,32171318,"Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial.","INTRODUCTION Knee osteoarthritis (KOA) is a chronic disease with symptoms of persistent pain or resting pain, joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. The use of acupuncture for the management of chronic pain is receiving increasing recognition from both the public and professionals. The aim of this study is to identify the effects of three commonly used acupuncture treatments for KOA. METHODS/ANALYSIS In a prospective trial involving six hospitals in Zhejiang Province (China), 360 patients with KOA will be included. Eligible patients will be randomized into six groups: Acupuncture, Electro-acupuncture, Mild moxibustion, Warm-needling, Sham acupuncture and Celebrex treatment. Twelve treatment sessions will be performed over a 4-week period. The primary outcome will be the visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores (the average of the past 3 days) at weeks 2 and 4 and at 3-month and 6-month follow-up. Secondary outcome measures will be as follows: the WOMAC pain score and WOMAC stiffness score (the average of the past 3 days); the Physical Activity Scale of the Elderly (PASE); knee joint swelling measurement; the WHO Quality Of Life-BREF (WHOQOL-BREF) life quality scale; and the incidence of adverse events. TRIAL REGISTRATION ClinicalTrials.gov, NCT03563690. Registered on 2rd July 2018.",2020,The primary outcome will be the visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores (the average of the past 3 days) at weeks 2 and 4 and at 3-month and 6-month follow-up.,"['Eligible patients', 'six hospitals in Zhejiang Province (China), 360 patients with KOA will be included', 'knee osteoarthritis']","['acupuncture', 'Acupuncture, Electro-acupuncture, Mild moxibustion, Warm-needling, Sham acupuncture and Celebrex treatment']","['visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores', 'WOMAC pain score and WOMAC stiffness score', 'Physical Activity Scale of the Elderly (PASE); knee joint swelling measurement; the WHO Quality Of Life-BREF (WHOQOL-BREF) life quality scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0719198', 'cui_str': 'Celebrex'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}]",360.0,0.113781,The primary outcome will be the visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores (the average of the past 3 days) at weeks 2 and 4 and at 3-month and 6-month follow-up.,"[{'ForeName': 'Qifei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'The Third Clinical Medical College, Zhejiang Chinese Medical University, No.548 Binwen Rd, Binjiang District, Hangzhou Zhejiang, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No.548 Binwen Rd, Binjiang District, Hangzhou Zhejiang, China. fangjianqiao7532@163.com.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture, Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, NO.219 Moganshan Road, Xihu District, Zhejiang, China.'}, {'ForeName': 'Jiayao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No.548 Binwen Rd, Binjiang District, Hangzhou Zhejiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No.548 Binwen Rd, Binjiang District, Hangzhou Zhejiang, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture, Hangzhou Red Cross Hospital, NO.208 Huanchengdong Road, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture, Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, NO.219 Moganshan Road, Xihu District, Zhejiang, China.'}]",Trials,['10.1186/s13063-019-4034-8'] 608,31306589,A Randomized Controlled Trial of PEEK Versus Titanium Interference Screws for Anterior Cruciate Ligament Reconstruction With 2-Year Follow-up.,"BACKGROUND Graft fixation with interference screws for anterior cruciate ligament (ACL) reconstruction is a highly successful technique. Polyether ether ketone (PEEK) is a novel thermoplastic polymer with high biocompatibility and mechanical properties that mimic native bone, and it can be imaged on computed tomography or magnetic resonance imaging (MRI) without signal flare. PURPOSE To compare the clinical performance of ACL reconstruction with PEEK and titanium interference screws at 2 years and to evaluate a novel method of measuring tunnel volume. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS A total of 133 patients underwent arthroscopic ACL reconstruction with 4-strand hamstring autografts and were randomized to have titanium or PEEK interference screws for femoral and tibial tunnel fixation. At 2 years, subjective Lysholm and International Knee Documentation Committee scores were assessed and clinical examination performed. At 12 months, MRI was performed to assess graft incorporation and cyst formation, and a novel technique was employed to measure tunnel volumes. RESULTS There were no significant differences in graft rerupture rate, contralateral ACL rupture rate, subjective outcomes, or objective outcomes. In the titanium and PEEK groups, MRI demonstrated high overall rates of graft integration (96%-100% and 90%-93%, respectively) and ligamentization (89% and 84%) and low rates of synovitis (22% and 10%) and cyst formation (0%-18% and 13%-15%). There was a higher proportion of patients with incomplete graft integration within the femoral tunnel in the PEEK group as compared with the titanium group (10% vs 0%, P = .03); however, the authors suggest that metal artifact precluded proper assessment of the graft in the titanium group by MRI. Tunnel volumes also appeared to be equivalent in the 2 groups and were measured with a novel technique that was highly reproducible in the PEEK group secondary to the absence of flare. CONCLUSION Two-year clinical analysis of PEEK interference screws for femoral and tibial fixation of ACL reconstructions showed equivalent clinical performance to titanium interference screws. Given the excellent mechanical characteristics, biological compatibility, and absence of metal artifact on MRI, PEEK has become our material of choice for interference screw fixation in ACL reconstruction.",2019,"There were no significant differences in graft rerupture rate, contralateral ACL rupture rate, subjective outcomes, or objective outcomes.","['Anterior Cruciate Ligament Reconstruction With 2-Year Follow-up', 'anterior cruciate ligament (ACL) reconstruction', '133 patients underwent']","['Polyether ether ketone (PEEK', 'arthroscopic ACL reconstruction with 4-strand hamstring autografts', 'ACL reconstruction with PEEK and titanium interference screws', 'Titanium Interference Screws', 'titanium or PEEK interference screws for femoral and tibial tunnel fixation', 'PEEK']","['Tunnel volumes', 'graft rerupture rate, contralateral ACL rupture rate, subjective outcomes, or objective outcomes', 'subjective Lysholm and International Knee Documentation Committee scores', 'low rates of synovitis', 'overall rates of graft integration', 'graft incorporation and cyst formation', 'cyst formation', 'incomplete graft integration']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3540034', 'cui_str': 'Ethers'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}]",133.0,0.078782,"There were no significant differences in graft rerupture rate, contralateral ACL rupture rate, subjective outcomes, or objective outcomes.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shumborski', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Heath', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}, {'ForeName': 'Lucy J', 'Initials': 'LJ', 'LastName': 'Salmon', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}, {'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Roe', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Linklater', 'Affiliation': 'Castlereagh Imaging, Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Facek', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}, {'ForeName': 'Leo A', 'Initials': 'LA', 'LastName': 'Pinczewski', 'Affiliation': 'North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.'}]",The American journal of sports medicine,['10.1177/0363546519861530'] 609,31322918,Biomechanical Comparison of Onlay Distal Biceps Tendon Repair: All-Suture Anchors Versus Titanium Suture Anchors.,"BACKGROUND A rupture of the distal biceps tendon is the most common tendon rupture of the elbow and has received increased attention in the past few years. Newly developed all-suture anchors have the potential to minimize surgical trauma and the risk of adverse events because of the use of flexible drills and smaller drill diameters. PURPOSE/HYPOTHESIS The purpose was to biomechanically compare all-suture anchors and titanium suture anchors for distal biceps tendon repair in cadaveric specimens. The hypothesis was that all-suture anchors would show no differences in load to failure or displacement under cyclic loading compared with titanium suture anchors. STUDY DESIGN Controlled laboratory study. METHODS Sixteen unpaired, fresh-frozen human cadaveric elbows were randomized to 2 groups, which underwent onlay distal biceps tendon repair with 2 anchors. Bone mineral density at the radial tuberosity was evaluated in each specimen. In the first group, distal biceps tendon repair was performed using all-suture anchors. In the second group, titanium suture anchors were applied. After cyclic loading for 3000 cycles, the repair constructs were loaded to failure. The peak load to failure as well as repair construct stiffness and mode of failure were determined. RESULTS The mean (±SD) peak load was 293.53 ± 122.15 N for all-suture anchors and 280.02 ± 69.34 N for titanium suture anchors ( P = .834); mean stiffness was 19.78 ± 2.95 N/mm and 19.30 ± 4.98 N/mm, respectively ( P = .834). The mode of failure was anchor pullout for all specimens during load to failure. At the proximal position, all-suture anchors showed a displacement of 1.53 ± 0.80 mm, and titanium suture anchors showed a displacement of 0.81 ± 0.50 mm ( P = .021) under cyclic loading. At the distal position, a displacement of 1.86 ± 1.04 mm for all-suture anchors and 1.53 ± 1.15 mm for titanium suture anchors was measured ( P = .345). A positive correlation between bone mineral density and load to failure was observed ( r = 0.605; P = .013). CONCLUSION All-suture anchors were biomechanically equivalent at time zero to titanium suture anchors for onlay distal biceps tendon repair. While the proximally placed all-suture anchors demonstrated greater displacement than titanium suture anchors, the comparable displacement at the distal position as well as the similar load and mechanism of failure make this difference unlikely to be clinically significant. CLINICAL RELEVANCE All-suture anchors performed similarly to titanium suture anchors for onlay distal biceps tendon repair at time zero and represent a reasonable alternative.",2019,All-suture anchors were biomechanically equivalent at time zero to titanium suture anchors for onlay distal biceps tendon repair.,"['cadaveric specimens', 'Sixteen unpaired, fresh-frozen human cadaveric elbows']","['Onlay Distal Biceps Tendon Repair: All-Suture Anchors Versus Titanium Suture Anchors', 'titanium suture anchors', 'onlay distal biceps tendon repair with 2 anchors', 'suture anchors and titanium suture anchors']","['bone mineral density and load to failure', 'distal biceps tendon repair', 'peak load to failure as well as repair construct stiffness and mode of failure', 'mean (±SD) peak load', 'Bone mineral density']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]","[{'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0397046,All-suture anchors were biomechanically equivalent at time zero to titanium suture anchors for onlay distal biceps tendon repair.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Otto', 'Affiliation': 'Department of Orthopaedic Surgery, UConn Musculoskeletal Institute, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Mehl', 'Affiliation': 'Department of Orthopaedic Sports Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Elifho', 'Initials': 'E', 'LastName': 'Obopilwe', 'Affiliation': 'Department of Orthopaedic Surgery, UConn Musculoskeletal Institute, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cote', 'Affiliation': 'Department of Orthopaedic Surgery, UConn Musculoskeletal Institute, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Lucca', 'Initials': 'L', 'LastName': 'Lacheta', 'Affiliation': 'Department of Orthopaedic Sports Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Scheiderer', 'Affiliation': 'Department of Orthopaedic Sports Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Andreas B', 'Initials': 'AB', 'LastName': 'Imhoff', 'Affiliation': 'Department of Orthopaedic Sports Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Augustus D', 'Initials': 'AD', 'LastName': 'Mazzocca', 'Affiliation': 'Department of Orthopaedic Surgery, UConn Musculoskeletal Institute, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Siebenlist', 'Affiliation': 'Department of Orthopaedic Sports Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}]",The American journal of sports medicine,['10.1177/0363546519860489'] 610,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed. Objective To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19. Design, Setting, and Participants Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled. Intervention Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity. Main Outcomes and Measures Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours. Results Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care. Conclusion and Relevance Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference. Trial Registration Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044'] 611,32179526,Significant Efficacy of a Single Low Dose of Primaquine Compared to Stand-Alone Artemisinin Combination Therapy in Reducing Gametocyte Carriage in Cambodian Patients with Uncomplicated Multidrug-Resistant Plasmodium falciparum Malaria.,"Since 2012, a single low dose of primaquine (SLDPQ; 0.25 mg/kg of body weight) with artemisinin-based combination therapies has been recommended as the first-line treatment of acute uncomplicated Plasmodium falciparum malaria to interrupt its transmission, especially in low-transmission settings of multidrug resistance, including artemisinin resistance. Policy makers in Cambodia have been reluctant to implement this recommendation due to primaquine safety concerns and a lack of data on its efficacy. In this randomized controlled trial, 109 Cambodians with acute uncomplicated P. falciparum malaria received dihydroartemisinin-piperaquine (DP) alone or combined with SLDPQ on the first treatment day. The transmission-blocking efficacy of SLDPQ was evaluated on days 0, 1, 2, 3, 7, 14, 21, and 28, and recrudescence by reverse transcriptase PCR (RT-PCR) (gametocyte prevalence) and membrane feeding assays with Anopheles minimus mosquitoes (gametocyte infectivity). Without the influence of recrudescent infections, DP-SLDPQ reduced gametocyte carriage 3-fold compared to that achieved with DP. Of 48 patients tested on day 0, only 3 patients were infectious to mosquitoes (∼6%). Posttreatment, three patients were infectious on day 14 (3.5%, 1/29) and on the 1st and 7th days of recrudescence (8.3%, 1/12 for each); this overall low infectivity precluded our ability to assess its transmission-blocking efficacy. Our study confirms the effective gametocyte clearance of SLDPQ when combined with DP in multidrug-resistant P. falciparum infections and the negative impact of recrudescent infections due to poor DP efficacy. Artesunate-mefloquine (ASMQ) has replaced DP, and ASMQ-SLDPQ has been deployed to treat all patients with symptomatic P. falciparum infections to further support the elimination of multidrug-resistant P. falciparum in Cambodia. (This study has been registered at ClinicalTrials.gov under identifier NCT02434952.).",2020,"Without the influence of recrudescent infections, DP+SLDPQ reduced gametocyte carriage 3 fold compared to DP.","['109 Cambodians with acute uncomplicated P. falciparum malaria received', 'Cambodian patients with uncomplicated multidrug resistant Plasmodium falciparum malaria']","['primaquine', 'stand alone artemisinin combination therapy', 'SLDPQ', 'primaquine (SLDPQ', 'Artesunate-mefloquine (ASMQ', 'dihydroartemisinin-piperaquine (DP) alone or combined with SLDPQ']","['gametocyte carriage', 'transcriptase polymerase chain reaction (RT-PCR) (gametocyte prevalence) and membrane-feeding assays with Anopheles minimus mosquitoes (gametocyte infectivity']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone (finding)'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0035681', 'cui_str': 'RNA Polymerases'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0322934', 'cui_str': 'Anopheles minimus (organism)'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0030657', 'cui_str': 'infectivity'}]",109.0,0.0456092,"Without the influence of recrudescent infections, DP+SLDPQ reduced gametocyte carriage 3 fold compared to DP.","[{'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Vantaux', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia amelie.vantaux@gmail.com.'}, {'ForeName': 'Saorin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Eakpor', 'Initials': 'E', 'LastName': 'Piv', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Sophy', 'Initials': 'S', 'LastName': 'Chy', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Berne', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Nimol', 'Initials': 'N', 'LastName': 'Khim', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control Program, Phnom Penh, Cambodia.'}, {'ForeName': 'Sovannaroth', 'Initials': 'S', 'LastName': 'Siv', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control Program, Phnom Penh, Cambodia.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Taylor', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Ménard', 'Affiliation': 'Malaria Molecular Epidemiology Unit, Institut Pasteur of Cambodia, Phnom Penh, Cambodia.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02108-19'] 612,32207067,Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.,"BACKGROUND Brodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis. OBJECTIVE This study summarizes malignancy rates in psoriasis clinical studies of brodalumab. METHODS Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of brodalumab for the treatment of psoriasis, including two studies with randomization to brodalumab, ustekinumab, or placebo. Data from the 52-week (brodalumab and ustekinumab) and long-term (brodalumab) pools were summarized as exposure-adjusted or follow-up time-adjusted event rates per 100 patient-years (PY). RESULTS Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4). The exposure-adjusted event rate of adjudicated malignancies in the brodalumab group remained stable in the long-term analysis (0.9 [82 events]). CONCLUSIONS Rates of malignancy among brodalumab-treated patients with psoriasis were generally low. TRIAL REGISTRY ClinicalTrials.gov identifier NCT00975637; NCT01101100; NCT01708590 (AMAGINE-1); NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).",2020,"RESULTS Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","['adults with moderate-to-severe plaque psoriasis', 'Data were pooled from one phase II study and three large, multicenter, phase III randomized studies of']","['brodalumab', 'brodalumab, ustekinumab, or placebo']",['Malignancy Rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.0899439,"RESULTS Exposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA. alice.gottlieb@mountsinai.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Bellevue Dermatology Clinic, Bellevue, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': 'Bausch Health US, LLC, Bridgewater, NJ, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Ortho Dermatologics, Bridgewater, NJ, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00512-4'] 613,32272037,Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,,2020,,['Muscle-Invasive Bladder Cancer'],['Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0405648,,"[{'ForeName': 'Sam S', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001055'] 614,32273162,Shooting STAR: reinterpreting the data from the 'Single Embryo TrAnsfeR of Euploid Embryo' randomized clinical trial.,"Preimplantation genetic testing for aneuploidy (PGT-A) still remains controversial in clinical practice. Recently, the randomized controlled trial, 'Single Embryo TrAnsfeR of Euploid Embryo' (STAR) by Munné and coworkers showed a similar live birth rate per intention to treat in the two study groups (PGT-A and controls). A wrong diagnosis and/or biopsy-related damage to the embryo might underlie these results. To assess the impact of these factors on the efficiency of PGT-A, the live birth rate of 'euploid' embryos transferred in the PGT-A group was compared with its ideal value, namely the live birth rate of embryos with the potential to implant and to give rise to a baby in the control group. This estimate has been derived using the results of the genetic testing reported in the STAR trial. According to this model, the STAR trial has demonstrated that transferring only blastocysts classified as 'euploid' after PGT-A leads to a reduction from 82.2% to 50.0% of the live birth rate for competent embryos, thus supporting the idea that PGT-A is associated with some embryo wastage.",2020,Preimplantation genetic testing for aneuploidy (PGT-A) still remains controversial in clinical practice.,[],[],[],[],[],[],,0.0495786,Preimplantation genetic testing for aneuploidy (PGT-A) still remains controversial in clinical practice.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pagliardini', 'Affiliation': 'Reproductive Sciences Laboratory, Division of Genetics and Cell Biology, IRCCS San Raffaele Scientific Institute, Milano 20132, Italy. Electronic address: pagliardini.luca@hsr.it.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Viganò', 'Affiliation': 'Reproductive Sciences Laboratory, Division of Genetics and Cell Biology, IRCCS San Raffaele Scientific Institute, Milano 20132, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Alteri', 'Affiliation': 'Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milano 20132, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Corti', 'Affiliation': 'Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milano 20132, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Obstetrics and Gynaecology Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via M. Fanti 6, Milan 20122, Italy; Dipartimento di Scienze Cliniche e di Comunità, University of Milan, via Fanti 6, Milan 20122, Italy.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Papaleo', 'Affiliation': 'Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milano 20132, Italy.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.015'] 615,32406998,Safety and efficacy of the bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents in high-risk patients undergoing PCI: TWILIGHT-SYNERGY.,"BACKGROUND Data examining the safety and efficacy of the bioabsorbable polymer (BP) drug-eluting stent (DES) as compared with durable polymer (DP) DES in high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited. METHODS We conducted a pre-specified analysis among patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES. Following successful PCI and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion. The primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)]. RESULTS Among enrolled participants (N = 9,006), 653 were treated exclusively with the SYNERGY BP-DES and 6,404 with a comparator DP-DES. Over 15 months, TLF rates were 6.4 and 6.1% among those receiving a SYNERGY BP-DES and a DP-DES, respectively (adjusted HR 0.93; 95% CI 0.64-1.35; p = .72). The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int  > .10). CONCLUSIONS The safety and efficacy profile of the SYNERGY BP-DES is comparable to that of contemporary DP-DES in high-risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving SYNERGY BP-DES or DP-DES.",2020,"The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int >0.10). ","['high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited', 'high-risk patients undergoing PCI', 'patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES', 'enrolled participants (N\xa0=\xa09006), 653 were treated exclusively with the SYNERGY BP-DES and 6404 with a comparator DP-DES']","['ticagrelor plus aspirin', 'bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents', 'bioabsorbable polymer (BP) drug-eluting stent (DES', 'durable polymer (DP) DES', 'ticagrelor monotherapy', 'aspirin or placebo']","['target lesion failure (TLF', 'Safety and efficacy', 'TLF rates', 'cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.196087,"The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both p int >0.10). ","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Zhongjie', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Bimmer E', 'Initials': 'BE', 'LastName': 'Claessen', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28995'] 616,32401625,The Effect of Home Base Physical Activity Program based on the BASNEF Model on Motor Recovery in Patients with Stroke.,"The present study aimed to determine the effect of education based on the BASNEF model on the physical activity and improvement of motor activity in patients with stroke. This randomized control trial study was conducted on 40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018. The patients were randomly divided into intervention and control groups. The intervention included personal education and a manual CD of physical activity for the intervention group. After education, the mean scores of the BASNEF model's constructs in the intervention group were significantly higher than those of the control group ( P < .001). Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p < .001). Interventions based on educational models can increase the motivation of patients with stroke in performing recommended physical activity.",2020,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p < .001).","['Patients with Stroke', '40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018', 'patients with stroke']",['Home Base Physical Activity Program'],"['motor ability', ""mean scores of the BASNEF model's constructs"", 'upper and lower extremities', 'motor activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0142828,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p < .001).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esteki-Ghashghaei', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Saadatnia', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences , Isfahan, Iran.'}]",Home health care services quarterly,['10.1080/01621424.2020.1765938'] 617,32199608,The Cost-effectiveness of Eltrombopag for the Treatment of Immune Thrombocytopenia in the United States.,"PURPOSE Eltrombopag was evaluated as a second-line treatment for adult chronic immune thrombocytopenia (ITP) in the 2006 Phase III RAISE (Eltrombopag for Management of Chronic Immune Thrombocytopenia) randomized, placebo-controlled trial. More than 80% of patients reached satisfactory platelet counts within 2 weeks. However, the economic value of eltrombopag as a second-line treatment for ITP remains to be formally assessed. This study aimed to estimate the cost-effectiveness of treating ITP with a comparable thrombopoietin receptor agonist (eltrombopag vs romiplostim). METHODS A Markov model was implemented over a lifetime time horizon to estimate the benefits and costs of each treatment. The model featured 3 health states based on current guidelines: (1) on treatment; (2) treatment failure/discontinuation; and (3) mortality. In line with therapeutic goals in ITP, model patients could experience 3 events: no bleeding, mild/moderate bleeding, or severe bleeding. Data on eltrombopag use were obtained from an open-label extension of previous Phase II/III trials, including RAISE. Romiplostim data were obtained from Phase III trials and an extension study. Lifetime overall survival was extrapolated by using treatment-specific mortality rates derived from severe bleeding and natural mortality rates. The costs of drugs, routine care, bleeding episodes, adverse events, and mortality were represented in the model. FINDINGS Eltrombopag-treated patients gained 17.58 life years and 14.68 quality-adjusted life years, whereas romiplostim-treated patients gained 17.52 life years and 14.67 quality-adjusted life years. The total lifetime cost of eltrombopag treatment was estimated at $1.58 million versus $2.13 million for romiplostim. Sensitivity analyses supported base case findings. Deterministic sensitivity analysis predicted the greatest sensitivity to the rates of severe bleeding, discontinuation, and natural mortality. Probabilistic sensitivity analysis showed that eltrombopag would be an efficient use of resources at a $50,000 threshold in 52.8% of cases. In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs. IMPLICATIONS Clinical data were applied in an economic analysis, and eltrombopag exhibited economic dominance compared with romiplostim, driven largely by the reduced costs of primary therapy. This model was limited by a lack of specific patient-level data and robust data on the duration of secondary therapy, as well as by the fact that utilization values are likely conservative estimates for routine care use.",2020,"In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs. ",['adult chronic immune thrombocytopenia (ITP) in the 2006 Phase III'],"['thrombopoietin receptor agonist (eltrombopag vs romiplostim', 'RAISE (Eltrombopag', 'placebo', 'Eltrombopag', 'eltrombopag']","['Lifetime overall survival', 'satisfactory platelet counts', 'costs of drugs, routine care, bleeding episodes, adverse events, and mortality', 'total lifetime cost of eltrombopag treatment', 'severe bleeding, discontinuation, and natural mortality', 'bleeding, mild/moderate bleeding, or severe bleeding', 'Immune Thrombocytopenia', 'total cost of eltrombopag treatment', 'Cost-Effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4522005', 'cui_str': 'Thrombopoietin receptor agonist'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0419083,"In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs. ","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Tremblay', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA. Electronic address: gabrieltremblay@pshta.com.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Dolph', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA.'}, {'ForeName': 'Anuja Nidumolu', 'Initials': 'AN', 'LastName': 'Roy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NY, USA.'}, {'ForeName': 'Qayyim', 'Initials': 'Q', 'LastName': 'Said', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NY, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsythe', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.020'] 618,32061400,"Preoperative, single, high-dose glucocorticoid administration in abdominal wall reconstruction: A randomized, double-blinded clinical trial.","BACKGROUND Although preoperative administration of high-dose glucocorticoid may lead to improved recovery after operative procedures, this regimen has not been examined in patients undergoing abdominal wall reconstruction for repair of large ventral hernias. The aim of the current trial was to examine the effects of preoperative, single high-dose glucocorticoid on recovery after abdominal wall reconstruction. METHOD Forty patients undergoing abdominal wall reconstruction for repair of ventral incisional hernias with a horizontal fascial defect >10 cm were randomized to intravenous administration of either 125 mg methylprednisolone or placebo at the induction of anesthesia. The primary endpoint was pain in the supine position as assessed by a numeric rating scale of 0 to 10 at rest at 8 am on the first postoperative day. Secondary outcomes included postoperative pain during activity, nausea, fatigue, inflammatory response (measured by plasma levels of C-reactive protein), duration of stay, and 30-day complications or readmissions. RESULTS There was no difference in pain at rest on the first postoperative day (methylprednisolone mean 1.7 vs placebo 2.2, P > .95), whereas patients in the methylprednisolone group reported less pain during activity (mean 3.0 vs 5.0; P = .011) and during coughing (3.4 vs 5.9; P = .010). There were no differences between the 2 groups regarding postoperative fatigue or nausea. Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). CONCLUSION A single-shot, high-dose methylprednisolone before abdominal wall reconstruction for a large incisional hernia decreased early postoperative pain and attenuated the inflammatory response.",2020,"Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). ","['abdominal wall reconstruction', 'patients undergoing abdominal wall reconstruction for repair of large ventral hernias', 'Forty patients undergoing abdominal wall reconstruction for repair of ventral incisional hernias with a horizontal fascial defect >10 cm']","['methylprednisolone', 'glucocorticoid', 'methylprednisolone or placebo']","['postoperative pain during activity, nausea, fatigue, inflammatory response (measured by plasma levels of C-reactive protein), duration of stay, and 30-day complications or readmissions', 'pain during activity', 'postoperative fatigue or nausea', 'Postoperative levels of C-reactive protein', 'pain', 'pain in the supine position as assessed by a numeric rating scale of 0 to 10 at rest']","[{'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0019326', 'cui_str': 'Ventral Hernia'}, {'cui': 'C0750175', 'cui_str': 'Ventral incisional hernia'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C0222045'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}]",40.0,0.452762,"Postoperative levels of C-reactive protein were less in the methylprednisolone group (P = .039). ","[{'ForeName': 'Kristian K', 'Initials': 'KK', 'LastName': 'Jensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark. Electronic address: mail@kristiankiim.dk.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Brøndum', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Bonna', 'Initials': 'B', 'LastName': 'Leerhøy', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Belhage', 'Affiliation': 'Department of Anaesthesia, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hensler', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Regnar B', 'Initials': 'RB', 'LastName': 'Arnesen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Denmark.'}]",Surgery,['10.1016/j.surg.2019.12.007'] 619,31228203,Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project.,"BACKGROUND The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) aimed to investigate whether a 3 months (3M) of oxaliplatin/fluoropyrimidine-based adjuvant chemotherapy (CT) is non-inferior to the 6-month (6M) administration in 3-year disease-free survival (3yDFS) in high-risk (HR) stage II or stage III colon cancer (CC). METHODS Hellenic Oncology Research Group (HORG)-IDEA randomized patients between 3M and 6M of CT with FOLFOX4 or CAPOX. RESULTS In total 1115 patients, 413 with HR stage II and 702 with stage III CC, were randomized. The median follow-up was 67.0 (38.3-126.0) months. Overall, 394 DFS events (202 in 3M arm and 192 in 6M arm) where recorded. The 3yDFS rate was 77.2% [95% confidence interval (CI) 72.1% to 82.3%] for 3M and 77.9% (72.6% to 82.5%) for 6M of treatment [hazard ratio (HR) 1.05 (95% CI 0.61-1.55); P = 0.647]. Eighty DFS events (3M N = 41; 6M N = 39) were observed in HR stage II patients for a 3yDFS rate of 82.7% and 83.4%, respectively (HR 1.05; 95% CI 0.68-1.63, P = 0.829). For stage III patients, 314 DFS events (3M N = 161 and 6M N = 153) were observed, for a 3yDFS rate of 72.9% for 3M versus 74.1% for 6M (HR 1.06; 95% CI 0.81-1.42, P = 0.622). For HR stage II patients receiving FOLFOX4, 3yDFS rate was 76.7% for 3M and 79.3% for 6M (HR 1.21; 95% CI 0.54-2.70). For HR stage II patients receiving CAPOX the 3yDFS rate was 85.4% for 3M and 83.8% for 6M (HR 0.99; 95% CI 0.59-1.67). For stage III patients receiving FOLFOX4, the 3yDFS rate was 71.5% for 3M and 77.3% for 6M (HR 1.18; 95% CI 0.74-1.86). For stage III patients receiving CAPOX, the 3yDFS rate was 74.5% for 3M and 74.7% for 6M (HR 0.99; 95% CI 0.70-1.44). CONCLUSIONS The results of the HORG-IDEA study are in line with those of the global IDEA project, indicating that the 3yDFS is dependent on the administered adjuvant regimen and the choice and duration of regimen should be personalized. CLINICALTRIALS.GOV REGISTRATION NUMBER NCT01308086.",2019,The 3y DFS rate was 77.2% (95% CI: 72.1-82.3%) for 3M and 77.9% (72.6-82.5%) for 6M of treatment [HR: 1.05 (95% CI: 0.61-1.55); p=0.647].,"['HORG-IDEA randomized patients between 3M and 6M of CT with FOLFOX4 or CAPOX', 'high risk stage II and stage III colon cancer patients', 'In total 1115 patients, 413 with HR stage II and 702 with stage III CC', '3-year disease-free survival (3yDFS) in high risk (HR) stage II or stage III colon cancer (CC']","['FOLFOX or CAPOX', 'oxaliplatin/fluoropyrimidine-based adjuvant chemotherapy (CT']","['Eighty DFS events', '3yDFS rate', 'DFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1115.0,0.216653,The 3y DFS rate was 77.2% (95% CI: 72.1-82.3%) for 3M and 77.9% (72.6-82.5%) for 6M of treatment [HR: 1.05 (95% CI: 0.61-1.55); p=0.647].,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Souglakos', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece. Electronic address: johnsougl@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Boukovinas', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kakolyris', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Xynogalos', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ziras', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Athanasiadis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Androulakis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Christopoulou', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vaslamatzis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ardavanis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Emmanouilides', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bompolaki', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kourousis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Makrantonakis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Christofyllakis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Athanasiadis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kentepozidis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karampeazis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Katopodi', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anagnosopoulos', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Papadopoulos', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Prinarakis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kalisperi', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mavroudis', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'Hellenic Oncology Research Group, Athens, Greece.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz193'] 620,31988028,Asthmatic children and MDI verbal inhalation technique counseling.,"OBJECTIVES The present work aimed to study the role of metered-dose inhalers (MDI) verbal counseling on asthmatic children patients inhalation technique and their pulmonary functions. METHODS In this study many children younger than 18 years old with asthma were collected from University hospital outpatient clinics throughout two years period Their MDI inhalation technique was checked and the number of MDI inhalation technique mistakes were detected and corrected at the first visit and every month for two more visits (three visits). Their peak expiratory flow (PEF) and forced expiratory volume in 1 s (FEV 1 ) as a percentage of the forced vital capacity (FVC) were checked at every visit. RESULTS 81 asthmatic subjects (54 female) younger than 18 years old were collected with a mean (SD) age 14.4 (1.8) years old. Most of the patients' owned MDI contained salbutamol, however, some patients were using Beclometasone MDI or Beclometasone and salbutamol combination MDI. The mean number of correct steps performed was significantly increased (p < 0.05) as the number of visits increased. ""Place the MDI mouthpiece between the teeth and seal with lips"" and ""To maintain slow inhalation rate until lungs are full"" were the least steps correctly performed by the asthmatics children studied. There was a significant increase (p < 0.05) in the pulmonary function test scores at the third visit. CONCLUSIONS MDI's verbal counseling should be repeated and checked at every opportunity, especially with children, to improve and maintain the recommended MDI inhalation technique. That could be a tool to possibly improve patients' pulmonary functions.",2020,The mean number of correct steps performed was significantly increased (p < 0.05) as the number of visits increased.,"['children younger than 18 years old with asthma were collected from University hospital outpatient clinics', '81 asthmatic subjects (54 female) younger than 18 years old were collected with a mean (SD) age 14.4 (1.8) years old', 'asthmatic children patients inhalation technique and their pulmonary functions', 'Asthmatic children and MDI verbal inhalation technique counseling']",['metered-dose inhalers (MDI) verbal counseling'],"['mean number of correct steps', 'pulmonary function test scores', 'number of MDI inhalation technique mistakes', 'peak expiratory flow (PEF) and forced expiratory volume in 1\u202fs (FEV 1 ) as a percentage of the forced vital capacity (FVC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",81.0,0.0112312,The mean number of correct steps performed was significantly increased (p < 0.05) as the number of visits increased.,"[{'ForeName': 'Marwa O', 'Initials': 'MO', 'LastName': 'Elgendy', 'Affiliation': 'Department of Clinical pharmacy, Teaching Hospital of Faculty of Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt; Department of Clinical pharmacy, Faculty of Pharmacy, Nahda university, Egypt.'}, {'ForeName': 'Amira H', 'Initials': 'AH', 'LastName': 'Hassan', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Saeed', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Abdelrahim', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. Electronic address: mohamedemam9@yahoo.com.'}, {'ForeName': 'Randa Salah', 'Initials': 'RS', 'LastName': 'Eldin', 'Affiliation': 'Department of Respiratory, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101900'] 621,32195715,Does a Hand Strength-Focused Exercise Program Improve Grip Strength in Older Patients With Wrist Fractures Managed Nonoperatively?: A Randomized Controlled Trial.,"OBJECTIVE Distal radius fractures in the older population significantly impair grip strength. The aim of the study was to investigate whether a hand strength focused exercise program during the period of immobilization for nonoperatively managed distal radius fractures in this population improved grip strength and quality of life. DESIGN This is a single-center randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization. The intervention group (n = 26) received a home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast. The control group (n = 26) performed finger range of motion exercises as per protocol. Primary outcome was grip strength ratio of injured arm compared with uninjured arm. Secondary outcome included functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand. Outcomes were measured at 2, 6, and 12 wks after injury. RESULTS The intervention group significantly improved grip strength ratio at both 6 and 12 wks (6 wks: 40% vs 25%, P = 0.0044, and 12 wks: 81% vs 51%, P = 0.0035). The intervention group improved the 11-item Disabilities of the Arm, Shoulder and Hand score at 12 wks; however, this was not statistically significant (25 vs 40, P = 0.066). CONCLUSIONS A hand strength-focused exercise program for elderly patients with distal radius fractures while immobilized significantly improved grip strength.",2020,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"['Older Patients', 'Fifty-two patients older than 60 yrs who experienced distal radius fractures managed nonoperatively with cast immobilization', 'elderly patients with distal radius fractures']","['home hand strength-focused exercise program from 2 and 6 wks after injury while immobilized in a full short arm cast', 'A hand strength-focused exercise program', 'hand strength focused exercise program', 'Hand Strength-Focused Exercise Program', 'finger range of motion exercises as per protocol']","['grip strength and quality of life', 'functional scores of the 11-item shortened version of the Disabilities of the Arm, Shoulder and Hand', '11-item Disabilities of the Arm, Shoulder and Hand score', 'grip strength ratio of injured arm compared with uninjured arm', 'grip strength ratio', 'grip strength']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0426857', 'cui_str': 'Short arm (finding)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0575830', 'cui_str': 'Joint movement: finger'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",52.0,0.0849428,The intervention group significantly improved grip strength ratio at both 6 and 12 wks,"[{'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'From the Liverpool Hospital, Liverpool, New South Wales, Australia (AN); Concord Hospital, Sydney, New South Wales, Australia (AN, MV, GB, DM, MW, MK, JS); and Royal North Shore Hospital, Sydney, New South Wales, Australia (GB, MK).'}, {'ForeName': 'Mehr', 'Initials': 'M', 'LastName': 'Vather', 'Affiliation': ''}, {'ForeName': 'Gobind', 'Initials': 'G', 'LastName': 'Bal', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Meaney', 'Affiliation': ''}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Kwa', 'Affiliation': ''}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Sungaran', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001317'] 622,32131082,Functional ability and quality of life in critical illness survivors with intensive care unit acquired weakness: A secondary analysis of a randomised controlled trial.,"INTRODUCTION Intensive care unit acquired weakness (ICUAW) may contribute to functional disability in ICU survivors, yet performance-based data for general ICU patients are lacking. This study explored functional outcomes of (1) and risk factors for (2) weakness at ICU discharge. METHODS Data from a randomised controlled trial that investigated two early exercise regimes in previously independent, ventilated adults (n = 115) without any significant outcome-differences were used for the present analysis. ICUAW was clinically diagnosed in cooperative participants (n = 83) at ICU discharge with the Medical Research Council sum-score (MRC-SS) using a cut-off <48 for moderate or <36 for severe weakness. Primary outcomes were the 6-Minute Walk Test and Functional Independence Measure at hospital discharge. Secondary outcomes included health-related quality of life after six months. Risk factors during the ICU stay were explored for their effect on MRC-SS with linear regression. RESULTS Functional outcomes and length of hospital stay significantly differed in patients with severe, moderate to no weakness (6-Minute Walk test: p = 0.013; 110m [IQR 75-240], 196m [90-324.25], 222.5m [129-378.75], Functional Independence Measure: p = 0.001; 91[IQR 68-101], 113[102.5-118.5], 112[97-123], length of stay after ICU discharge: p = 0.008; 20.9d [IQR 15.83-30.73], 16.86d [13.07-27.10], 11.16d [7.35-19.74]). However, after six months participants had similar values for quality of life regardless of their strength at ICU discharge (Short-Form 36 sum-scores physical health: p = 0.874, mental health: p = 0.908). In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI [-37.03 to -12.11]); p<0.001). CONCLUSIONS In this general, critically ill cohort, weakness at ICU discharge was associated with short-term functional disability and prolonged hospital length of stay, but not with quality of life, which was equivalent to the values for patients without ICUAW within six months. Immobilisation may be a modifiable risk factor to prevent ICUAW. Prospective trials are needed to validate these results. TRIAL REGISTRATION German Clinical Trials Register (DRKS) identification number: DRKS00004347, registered on September 10, 2012.",2020,In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI,"['critical illness survivors with intensive care unit acquired weakness', 'previously independent, ventilated adults (n = 115']",[],"['length of hospital stay', '6-Minute Walk Test and Functional Independence Measure at hospital discharge', 'health-related quality of life', 'quality of life regardless of their strength at ICU discharge', 'Functional ability and quality of life']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",115.0,0.270823,In-bed immobilisation was the most significant factor associated with weakness at ICU discharge in the regression models (MRC-SS: -24.57(95%CI,"[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eggmann', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Gere', 'Initials': 'G', 'LastName': 'Luder', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Verra', 'Affiliation': 'Department of Physiotherapy, Insel Group, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Irincheeva', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Department of Epidemiology, Research Line Functioning and Rehabilitation CAPHRI, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}]",PloS one,['10.1371/journal.pone.0229725'] 623,32066497,Intrapulmonary concentrations of meropenem administered by continuous infusion in critically ill patients with nosocomial pneumonia: a randomized pharmacokinetic trial.,"BACKGROUND Optimal antimicrobial drug exposure in the lung is required for successful treatment outcomes for nosocomial pneumonia. Little is known about the intrapulmonary pharmacokinetics (PK) of meropenem when administered by continuous infusion (CI). The aim of this study was to evaluate the PK of two dosages of meropenem (3 g vs 6 g/day by CI) in the plasma and epithelial lining fluid (ELF) in critically ill patients with nosocomial pneumonia. METHODS Thirty-one patients (81% male, median (IQR) age 72 (22) years) were enrolled in a prospective, randomized, clinical trial. Sixteen patients received 1 g/8 h and 15 2 g/8 h by CI (8 h infusion). Plasma and ELF meropenem concentrations were modeled using a population methodology, and Monte Carlo simulations were performed to estimate the probability of attaining (PTA) a free ELF concentration of 50% of time above MIC (50% fT>MIC), which results in logarithmic killing and the suppression of resistance in experimental models of pneumonia. RESULTS The median (IQR) of meropenem AUC 0-24 h in the plasma and ELF was 287.6 (190.2) and 84.1 (78.8) mg h/L in the 1 g/8 h group vs 448.1 (231.8) and 163.0 (201.8) mg h/L in the 2 g/8 h group, respectively. The penetration ratio was approximately 30% and was comparable between the dosage groups. In the Monte Carlo simulations, only the highest approved dose of meropenem of 2 g/8 h by CI allowed to achieve an optimal PTA for all isolates with a MIC < 4 mg/L. CONCLUSIONS An increase in the dose of meropenem administered by CI achieved a higher exposure in the plasma and ELF. The use of the highest licensed dose of 6 g/day may be necessary to achieve an optimal coverage in ELF for all susceptible isolates (MIC ≤ 2 mg/L) in patients with conserved renal function. An alternative therapy should be considered when the presence of microorganisms with a MIC greater than 2 mg/L is suspected. TRIAL REGISTRATION The trial was registered in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT-no. 2016-002796-10). Registered on 27 December 2016.",2020,The penetration ratio was approximately 30% and was comparable between the dosage groups.,"['Thirty-one patients (81% male, median (IQR) age 72 (22) years', 'patients with conserved renal function', 'critically ill patients with nosocomial pneumonia']",['meropenem'],"['Plasma and ELF meropenem concentrations', 'plasma and epithelial lining fluid (ELF', 'median (IQR) of meropenem AUC 0-24\xa0h in the plasma and ELF', 'penetration ratio']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1443237', 'cui_str': 'Nosocomial Pneumonia'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",16.0,0.131405,The penetration ratio was approximately 30% and was comparable between the dosage groups.,"[{'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Benítez-Cano', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. ABenitez-cano@parcdesalutmar.cat.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Luque', 'Affiliation': ""Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain. sluque@parcdesalutmar.cat.""}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Sorlí', 'Affiliation': ""Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Carazo', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ramos', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Campillo', 'Affiliation': ""Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Curull', 'Affiliation': 'Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Sánchez-Font', 'Affiliation': 'Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Vilaplana', 'Affiliation': 'Laboratory Department, Laboratori de Referència de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Horcajada', 'Affiliation': ""Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Adalia', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bermejo', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Samsó', 'Affiliation': 'Department of Anaesthesiology and Surgical Intensive Care, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool and Royal Liverpool Broadgreen University Hospital Trust, Liverpool, UK.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Grau', 'Affiliation': ""Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}]","Critical care (London, England)",['10.1186/s13054-020-2763-4'] 624,31895032,"A Practical Method for Ablation Catheter Reintroduction into the Left Atrium via Prior Transseptal Puncture, without Radiation.","BACKGROUND We evaluated the feasibility and safety of reintroducing an ablation catheter (ABL) into the left atrium (LA) through a previously punctured interatrial septum under guidance of the show-catheter image-track function of the CARTO 3 3-dimensional (3D) electroanatomic mapping system. METHODS One hundred consecutive paroxysmal or persistent drug-refractory atrial fibrillation (AF) patients (men: 55; mean age, 64.7 ± 12.1 years) who had undergone 2 fluoroscopy-guided transseptal punctures and anatomical LA reconstruction under CARTO 3-guidance, and required ABL reinsertion into the LA during mapping or ablation, were included. They were randomized 1:1 to the show-catheter (reintroduction under the CARTO 3 show-catheter image-track function) or fluoroscopy group (reintroduction under conventional fluoroscopy). RESULTS Although the reconstructed 3D anatomy map was displaced in 21/100 patients (21.0%), the ABL was successfully reintroduced in all patients. In the show-catheter and fluoroscopy groups, model displacement incidence (18% versus 24%), tachyarrhythmias (46.0% versus 52.0%), complications (2% versus 4%), and number of ABLs reintroduced into the LA (3.3 ± 0.8 versus 3.1 ± 0.9) were similar (all P > .05). The show-catheter group displayed shorter ABL reintroduction time (9.5 ± 5.5 s versus 156.4 ± 35.5 s, P < .01), ABL reintroduction X-ray exposure time (0 s versus 39.3 ± 13.8 s, P < .01), and total X-ray exposure time (4.1 ± 1.4 min versus 4.7 ± 0.8, P < .05). CONCLUSION During AF ablation, the catheter can be safely reintroduced into the LA, without additional fluoroscopy, under guidance of the CARTO 3 show-catheter image track function.",2019,"Although the reconstructed 3D anatomy map was displaced in 21/100 patients (21.0%), the ABL was successfully reintroduced in all patients.","['One hundred consecutive paroxysmal or persistent drug-refractory atrial fibrillation (AF) patients (men: 55; mean age, 64.7 ± 12.1 years) who had undergone 2 fluoroscopy-guided transseptal punctures and anatomical LA reconstruction under CARTO 3-guidance, and required ABL reinsertion into the LA during mapping or ablation, were included']","['reintroducing an ablation catheter (ABL', 'show-catheter (reintroduction under the CARTO 3 show-catheter image-track function) or fluoroscopy group (reintroduction under conventional fluoroscopy']","['number of ABLs reintroduced into the LA', 'total X-ray exposure time', 'model displacement incidence', 'complications', 'shorter ABL reintroduction time', 'tachyarrhythmias', 'ABL reintroduction X-ray exposure time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0589490', 'cui_str': 'Transseptal cardiac approach (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",100.0,0.0273349,"Although the reconstructed 3D anatomy map was displaced in 21/100 patients (21.0%), the ABL was successfully reintroduced in all patients.","[{'ForeName': 'Lingpin', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': 'The First Affiliated Hospital, Jinan University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Song-Wen', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Gen-Qing', 'Initials': 'GQ', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital, Jinan University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shi-An', 'Initials': 'SA', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China.'}, {'ForeName': 'Shao-Wen', 'Initials': 'SW', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",The heart surgery forum,['10.1532/hsf.2621'] 625,31390688,Effects of the Short Foot Exercise With Neuromuscular Electrical Stimulation on Navicular Height in Flexible Flatfoot in Thailand: A Randomized Controlled Trial.,"OBJECTIVES Flatfoot, or low medial longitudinal arch, contributes to back and lower extremity injuries and is caused by weak abductor hallucis (AbdH) muscles. The purpose of this study was to investigate the effects of short foot exercise (SFE) alone or with neuromuscular electrical stimulation (NMES) on navicular height, the cross-sectional area (CSA) of the AbdH muscle, and AbdH muscle activity in flexible flatfoot. METHODS Thirty-six otherwise healthy people with flexible flatfoot were randomly assigned to a group that received SFE with placebo NMES treatment (the control group) or a group that received both SFE and NMES treatment (the experimental group). Each group received 4 weeks of treatment (SFE alone or SFE with NMES). Navicular height, the CSA of the AbdH muscle, and AbdH muscle activity were assessed before and after the intervention. RESULTS No significant differences were found in navicular height or the CSA of the AbdH muscle between the control and experimental groups, while AbdH muscle activity showed a statistically significant difference between the groups (SFE=73.9±11.0% of maximal voluntary isometric contraction [MVIC]; SFE with NMES=81.4±8.3% of MVIC; p<0.05). Moreover, the CSA of the AbdH muscle showed a statistically significant increase after treatment in the SFE with NMES group (pre-treatment=218.6±53.2 mm2; post-treatment=256.9±70.5 mm2; p<0.05). CONCLUSIONS SFE with NMES was more effective than SFE alone in increasing AbdH muscle activity. Therefore, SFE with NMES should be recommended to correct or prevent abnormalities in people with flexible flatfoot by a physiotherapist or medical care team.",2019,"No significant differences were found in navicular height or the CSA of the AbdH muscle between the control and experimental groups, while AbdH muscle activity showed a statistically significant difference between the groups (SFE=73.9±11.0% of maximal voluntary isometric contraction [MVIC]; SFE with NMES=81.4±8.3% of MVIC; p<0.05).","['Thirty-six otherwise healthy people with flexible flatfoot', 'Navicular Height in Flexible Flatfoot in Thailand']","['SFE with placebo NMES treatment', 'short foot exercise (SFE) alone or with neuromuscular electrical stimulation (NMES', 'SFE with NMES', 'SFE', 'SFE and NMES treatment', 'treatment (SFE alone or SFE with NMES', 'NMES', 'Short Foot Exercise With Neuromuscular Electrical Stimulation']","['AbdH muscle activity', 'Navicular height, the CSA of the AbdH muscle, and AbdH muscle activity', 'navicular height, the cross-sectional area (CSA) of the AbdH muscle, and AbdH muscle activity', 'navicular height or the CSA of the AbdH muscle']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0152237', 'cui_str': 'Talipes Calcaneovalgus'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C1870204', 'cui_str': '(18F)SFE'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0576226', 'cui_str': 'Short foot (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",,0.0267433,"No significant differences were found in navicular height or the CSA of the AbdH muscle between the control and experimental groups, while AbdH muscle activity showed a statistically significant difference between the groups (SFE=73.9±11.0% of maximal voluntary isometric contraction [MVIC]; SFE with NMES=81.4±8.3% of MVIC; p<0.05).","[{'ForeName': 'Juntip', 'Initials': 'J', 'LastName': 'Namsawang', 'Affiliation': 'School of Physiotherapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen,Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Eungpinichpong', 'Affiliation': 'Research Center in Back, Neck and Other Joint Pain and Human Performance (BNOJPH), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Vichiansiri', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Rattanathongkom', 'Affiliation': 'School of Physiotherapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen,Thailand.'}]",Journal of preventive medicine and public health = Yebang Uihakhoe chi,['10.3961/jpmph.19.072'] 626,32187236,An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial.,"OBJECTIVE To determine if an internet-based mind/body program would lead to participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention. Secondary exploratory goals were to examine reduced distress over the course of the intervention and increased likelihood to conceive. METHODS This was a pilot randomized controlled feasibility trial with a between-groups, repeated measure design. Seventy-one women self-identified as nulliparous and meeting criteria for infertility. Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments. Primary outcomes include retention rates, number of modules completed, and satisfaction with intervention. Secondary exploratory outcomes sought to provide preliminary data on the impact of the program on distress (anxiety and depression) and self-reported pregnancy rates relative to a quasi-control group. RESULTS The retention, adherence, and satisfaction rates were comparable to those reported in other internet-based RCTs. Although time between pre- and post-assessment differed between groups, using intent-to-treat analyses, women in the intervention group (relative to the wait-list group) had significant reduction in distress (anxiety, p = .003; depression, p = .007; stress, p = .041 fertility-social, p = .018; fertility-sexual, p = .006), estimated as medium-to-large effect sizes (ds = 0.45 to 0.86). The odds of becoming pregnant was 4.47 times higher for the intervention group participants as compared to the wait-list group, OR 95% CI [1.56, 12.85], p = .005 and occurred earlier. The findings suggest that the research design and program specific to this population are feasible and acceptable. Replication efforts with an active control group are needed to verify distress reduction and conception promotion findings.",2020,"Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments.","['Seventy-one women self-identified as nulliparous and meeting criteria for infertility', 'participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention', 'women experiencing infertility']","['internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments', 'internet-based mind/body intervention', 'internet-based mind/body program']","['retention rates, number of modules completed, and satisfaction with intervention', 'retention, adherence, and satisfaction rates', 'distress (anxiety', 'distress (anxiety and depression) and self-reported pregnancy rates']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",,0.0891781,"Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Clifton', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Parent', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Seehuus', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Garyn', 'Initials': 'G', 'LastName': 'Worrall', 'Affiliation': 'Department of Medicine, Larner College of Medicine at The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Forehand', 'Affiliation': 'Department of Psychological Sciences, The University of Vermont, Burlington, Vermont, United States of America.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Domar', 'Affiliation': 'Boston IVF, Waltham, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229379'] 627,32187610,Measuring the impact of the French version of The Whiplash Book on both treatment approach and fear-avoidance beliefs among emergency physicians. A cluster randomized controlled trial.,"BACKGROUND Whiplash-associated disorders have been the subject of much attention in the scientific literature and remain a major public health problem. OBJECTIVE Measure the impact of a validated information booklet on the fear-avoidance beliefs of emergency physicians and their approach to management regarding the treatment of whiplash-associated disorders. METHODS A prospective cluster randomized controlled study conducted with a sample of emergency medicine physicians. Fear-avoidance beliefs were measured using The Whiplash Belief Questionnaire (WBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ). We assessed the approach to management based on the prescription of pharmacological and non-pharmacological treatments based on the advice given to patients. The validated information booklet was the French version of The Whiplash Book. A set of questionnaires was sent to participants pre- and post-intervention. The experimental intervention was the provision of The Whiplash Book. The control arm did not receive any training or information. RESULTS Mean fears and beliefs scores on inclusion were high: WBQ = 19.09 (± 4.06); physical activity FABQ = 11.45 (± 4.73); work FABQ = 13.85 (± 6.70). Improvement in fear-avoidance beliefs scores being greater in the intervention group was further confirmed by the variation in WBQ (-20 [-32; -6] vs. -6 [-16; 9]; p = 0.06), physical activity FABQ (-70 [-86; -50] vs. -15 [-40; 11]; p < 0.001), and work FABQ (-40 [-71; 0] vs. 0 [-31; 50]; p = 0.02). The emergency physicians' initial approach to management was not consistent with current guidelines. Reading the French version of The Whiplash Book could contribute to changing their approach to management in several areas on intra-group analysis. CONCLUSION The French version of The Whiplash Book positively influenced fear-avoidance beliefs among emergency physicians.",2020,Fear-avoidance beliefs were measured using The Whiplash Belief Questionnaire (WBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ).,"['emergency physicians', 'whiplash-associated disorders', 'sample of emergency medicine physicians']","['validated information booklet', 'control arm did not receive any training or information']","['physical activity FABQ', 'Whiplash Belief Questionnaire (WBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ', 'Fear-avoidance beliefs', 'fear-avoidance beliefs', 'work FABQ', 'fear-avoidance beliefs scores', 'Mean fears and beliefs scores']","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0406218,Fear-avoidance beliefs were measured using The Whiplash Belief Questionnaire (WBQ) and Fear-Avoidance Beliefs Questionnaire (FABQ).,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lanhers', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Poizat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Innovation and Clinical Research, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'Auclair', 'Affiliation': 'Department of Public Health, Biostatistics Unit, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Perrier', 'Affiliation': 'Emergency Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Jeannot', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Clermont-Ferrand Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gerbaud', 'Affiliation': 'Clermont-Ferrand Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coudeyre', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}]",PloS one,['10.1371/journal.pone.0229849'] 628,32199799,Durations of intrauterine balloon therapy and adhesion reformation after hysteroscopic adhesiolysis: a randomized controlled trial.,"RESEARCH QUESTION Does placing an intrauterine balloon for different durations (7, 14 or 28 days) affect the recurrence of intrauterine adhesions after hysteroscopic adhesiolysis? DESIGN Prospective randomized control trial involving 138 patients recruited over a 12-month period and followed up post-operatively for 15 months. The primary outcome measure was the rate of adhesion reformation at third-look hysteroscopy. RESULTS At third-look hysteroscopy, 8 weeks after the initial hysteroscopy, the adhesion recurrence rate in women who had an intrauterine balloon for 28 days (20%) was significantly (P < 0.01) lower than that of women who had the balloon for 14 days (55%) or 7 days (36.8%). CONCLUSIONS Placing an intrauterine balloon for 28 days instead of 7 or 14 days after hysteroscopic adhesiolysis resulted in a greater reduction in the recurrence rate of adhesions. However, the study was underpowered to address whether the ongoing pregnancy rate could be improved by keeping the balloon in the uterine cavity for a longer period of time.",2020,"RESEARCH QUESTION Does placing an intrauterine balloon for different durations (7, 14 or 28 days) affect the recurrence of intrauterine adhesions after hysteroscopic adhesiolysis? ","['hysteroscopic adhesiolysis', '138 patients recruited over a 12-month period and followed up post-operatively for 15 months']",['intrauterine balloon therapy'],"['recurrence of intrauterine adhesions', 'adhesion recurrence rate', 'rate of adhesion reformation at third-look hysteroscopy', 'recurrence rate of adhesions']","[{'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1704274', 'cui_str': 'Intrauterine adhesions (disorder)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}]",138.0,0.140032,"RESEARCH QUESTION Does placing an intrauterine balloon for different durations (7, 14 or 28 days) affect the recurrence of intrauterine adhesions after hysteroscopic adhesiolysis? ","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Yuhuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China. Electronic address: liuyh3844@sina.com.'}, {'ForeName': 'Tin-Chiu', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China; Department of Obstetrics and Gynecology, Prince of Wales Hospital, The Chinese University of Hong Kong, ShatinHong Kong 852, China.'}, {'ForeName': 'Enlan', 'Initials': 'E', 'LastName': 'Xia', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Qiaoyun', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Hysteroscopy Center, Fu Xing Hospital, Capital Medical University, Beijing 100038, China.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.11.017'] 629,32195649,"A pooled analysis of patients with wound infections in the Phase 3 REVIVE trials: randomized, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin structure infections.","Introduction. Iclaprim is a diaminopyrimidine antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to Gram-positive pathogens. Aim. This analysis evaluates patients with wound infections from two Phase 3 trials of ABSSSI. Methodology. Six-hundred-two patients with wound infections from two Phase 3, double-blinded, randomized, multicenter, active controlled trials (REVIVE-1/-2) were evaluated in a post hoc analysis of iclaprim 80 mg compared with vancomycin 15 mg kg -1 administered intravenously every 12 h for 5-14 days. The primary endpoint was to determine whether iclaprim was non-inferior (10 % margin) to vancomycin in achieving a ≥20 % reduction from baseline in lesion size 48-72 h after starting study drug (early clinical response [ECR]). Safety was assessed. Results. In REVIVE-1, ECR was 83.5 % with iclaprim versus 79.7 % with vancomycin (treatment difference 3.77%, 95 % CI -4.50%, 12.04%). In REVIVE-2, ECR was 82.7 % with iclaprim versus 76.3 % with vancomycin (treatment difference 6.38%, 95 % CI -3.35%, 16.12%). In the pooled dataset, iclaprim had similar ECR rates compared with vancomycin among wound infection patients (83.2 % vs 78.2 %) with a treatment difference of 5.01 % (95 % CI -1.29%, 11.32%). The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8). Conclusion. Based on early clinical response, iclaprim achieved non-inferiority to vancomycin with a similar safety profile in patients with wound infections suspected or confirmed as caused by Gram-positive pathogens. Iclaprim may be a valuable treatment option for wound infections.",2020,"The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8).","['patients with wound infections from two Phase 3 trials of ABSSSI', 'Six-hundred-two patients with wound infections', 'acute bacterial skin and skin structure infections', 'patients with wound infections', 'patients with wound infections suspected or confirmed as caused by Gram-positive pathogens']","['Iclaprim', 'iclaprim', 'diaminopyrimidine antibiotic', 'iclaprim versus vancomycin', 'vancomycin', 'iclaprim 80\u2009mg compared with vancomycin']","['ECR rates', 'safety and efficacy', 'diarrhea', 'safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}]","[{'cui': 'C1452002', 'cui_str': 'iclaprim'}, {'cui': 'C3653442', 'cui_str': 'Diaminopyrimidines'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",602.0,0.602536,"The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin ( n =17) compared with iclaprim ( n =6) and fatigue with iclaprim ( n =17) compared with vancomycin ( n =8).","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Noviello', 'Affiliation': 'Motif BioSciences, Princeton, New Jersey, USA.'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Holland', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Riordan"", 'Affiliation': 'eStudySite, San Diego, California, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals & University of Leeds, Leeds, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Summa Health, Akron, Ohio, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dryden', 'Affiliation': 'Department of Microbiology and Infection, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Balser', 'Affiliation': 'Veristat, Southborough, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Scaramucci', 'Affiliation': 'Veristat, Southborough, Massachusetts, USA.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': ""Department of Pulmonology, Hospital Clinic of Barcelona, University of Barcelona, Institut D'investigacions August Pi I Sunyer, Centro de Investigación Biomedica En Red-Enfermedades Respiratorias, Barcelona, Spain.""}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Huang', 'Affiliation': 'Motif BioSciences, Princeton, New Jersey, USA.'}]",Journal of medical microbiology,['10.1099/jmm.0.001177'] 630,32176342,Contribution of Haptic Simulation to Analogic Training Environment in Restorative Dentistry.,"The aim of this study was to evaluate the contribution of virtual reality to the conventional analogic training environment and show the complementarity of conventional techniques and virtual reality in the learning of dental students. All 88 first-year dental students at a dental school in France in early 2019 were randomly assigned to one of two groups: group 1 (n = 45) was assigned to cavity preparations on a haptic simulator (Virteasy) and group 2 (n = 43) was assigned to conventional practical work on plastic analogue teeth (Kavo). Following three training sessions, the students in group 1 took a final exam on the same plastic analogue teeth exercise. The results showed improvement in the drilling skill of both groups. The simulator-trained group (group 1) had similar results to the plastic analogue-trained group (group 2) in the final test on a plastic analogue tooth. In this study, virtual reality allowed an assessment based on objective criteria and reduced the subjectivity of evaluations conducted on plastic analogue teeth. Considering the saving of supervision and teaching time as well as the material gain offered by virtual reality, the learning methods of haptic simulators are educational options that should be considered by dental educators.",2020,The simulator-trained group (group 1) had similar results to the plastic analogue-trained group (group 2) in the final test on a plastic analogue tooth.,"['All 88 first-year dental students at a dental school in France in early 2019', 'dental students', 'Restorative Dentistry']","['plastic analogue-trained group (group 2) in the final test on a plastic analogue tooth', 'cavity preparations on a haptic simulator (Virteasy) and group 2 (n = 43) was assigned to conventional practical work on plastic analogue teeth (Kavo', 'Haptic Simulation']",['drilling skill'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0036376', 'cui_str': 'Schools, Dental'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1171316', 'cui_str': 'Restorative dentistry'}]","[{'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]",[],,0.022475,The simulator-trained group (group 1) had similar results to the plastic analogue-trained group (group 2) in the final test on a plastic analogue tooth.,"[{'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Periodontology, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Amory', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Paoli', 'Affiliation': 'Department of Periodontology, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Ambrosini', 'Affiliation': 'Department of Periodontology, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Mortier', 'Affiliation': 'Department of Restorative Dentistry and Endodontics, Faculty of Odontology of Nancy, France.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Operational Director, School of Surgery of Nancy-Lorraine, France.'}]",Journal of dental education,['10.21815/JDE.019.187'] 631,30702021,Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.,"PURPOSE To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. RESULTS The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. CONCLUSION The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.",2019,"The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group.","['Femoropopliteal Lesions', 'Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis']","['Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty', 'provisional stenting', 'percutaneous transluminal angioplasty (PTA', 'self-expanding nitinol stents']","['vessel revascularization (TVR) and target lesions revascularization (TLR', '3-year primary patency rate', 'technical success rate', 'patency rate', 'frequency of vascular dissection']","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1395545', 'cui_str': 'Vascular dissection'}]",105.0,0.21189,"The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group.","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': '1 Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Urasawa', 'Affiliation': '2 Department of Cardiology, Tokeidai Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Komura', 'Affiliation': '3 Cardiovascular Center, Kaisei Hospital, Sakaide, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': '4 Department of Cardiology, Kokura Memorial Hospital, Kitakyushyu, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': '5 Cardiovascular Center, Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': '6 Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yajima', 'Affiliation': '7 Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': '8 Cardiovascular Center, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': '9 Department of Surgery, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': '10 Department of Cardiology, Kasukabe Chuo General Hospital, Kasukabe, Saitama, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': '11 Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Horita', 'Affiliation': '12 Department of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Kichikawa', 'Affiliation': '13 Department of Radiology, Nara Medical University Hospital, Nara, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Yokoi', 'Affiliation': '14 Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Miyamoto', 'Affiliation': '15 Cardiovascular Center, Department of Cardiology, Takatsu General Hospital, Aichi, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': '6 Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': '16 Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': '1 Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': '17 Department of Cardiology, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819826591'] 632,32179010,Comparison of stimulated versus modified natural cycles for endometrial preparation prior to frozen embryo transfer: a randomized controlled trial.,"RESEARCH QUESTION To compare stimulated cycle (STC) versus modified natural cycle (MNC) for endometrial preparation prior to frozen embryo transfer (FET) in terms of convenience and efficacy. DESIGN Prospective, open-label, randomized controlled study including 119 patients aged 20-38 years, undergoing intra-conjugal IVF/intracytoplasmic sperm injection, having regular cycles, at least two day 2 or day 3 frozen embryos, for whom it was the first or second FET performed, randomized to either MNC (n = 59) or STC (n = 60). Monitoring consisted of ultrasound and hormonal measurements. The number of monitoring visits required was compared between the two groups. RESULTS STC required a significantly lower number of monitoring visits compared with MNC (3.6 ± 0.9 versus 4.4 ± 1.1, respectively, P < 0.0001), a lower number of blood tests (2.7 ± 0.8 versus 3.5 ± 1.0, respectively, P < 0.0001) and of ultrasounds (1.2 ± 0.4 versus 1.5 ± 0.6, respectively, P = 0.0039). FET during 'non-opening' hours (22.6% versus 27.5%, respectively, P = 0.32) and cancellation rates (11.7% versus 11.9%, respectively, P = 0.97) were comparable between the STC and MNC groups. No difference concerning HCG-positive rates (34.0% versus 23.1%, respectively, P = 0.22) nor live birth rates (24.5% for STC versus 23.1% for MNC, respectively, P = 0.86) was observed. Quality of life as defined by the FertiQol score was not different (P > 0.05 for each item). CONCLUSION Altogether, these findings can be used for everyday clinical practice to better inform patients when deciding on the protocol to use for FET. These results suggest that MNC is a good option for patients reluctant to have injections, but requires increased monitoring. STC may offer more flexibility for patients and IVF centres.",2020,"Quality of life as defined by the FertiQol score was not different (P > 0.05 for each item). ","['119 patients aged 20-38 years, undergoing intra-conjugal IVF/intracytoplasmic sperm injection, having regular cycles, at least two day 2 or day 3 frozen embryos, for whom it was the first or second FET performed, randomized to either', 'endometrial preparation prior to frozen embryo transfer']","['stimulated versus modified natural cycles', 'STC', 'stimulated cycle (STC) versus modified natural cycle (MNC) for endometrial preparation prior to frozen embryo transfer (FET', 'MNC', 'FET']","['number of blood tests', 'FertiQol score', 'number of monitoring visits', 'live birth rates', 'Quality of life', 'cancellation rates', 'HCG-positive rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0440733', 'cui_str': 'Frozen embryo (substance)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0034380'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",119.0,0.0485883,"Quality of life as defined by the FertiQol score was not different (P > 0.05 for each item). ","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Labrosse', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Lobersztajn', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France; Department of Gynecology, Obstetrics and Reproductive Medicine, Hôpital Pierre Rouquès Les Bluets, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pietin-Vialle', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Villette', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Anne Lucie', 'Initials': 'AL', 'LastName': 'Dessapt', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France; IVI Clinic Barcelona Barcelona, Spain.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Clinical Research Centre, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Brussieux', 'Affiliation': 'Clinical Research Centre, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Bry-Gauillard', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Pasquier', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Massin', 'Affiliation': 'Department of Gynecology, Obstetrics and Reproductive Medicine, Centre Hospitalier Intercommunal de Créteil, Université Paris-Est Créteil, Créteil, France. Electronic address: nathalie.massin@chicreteil.fr.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.007'] 633,30772205,"Food, Health, & Choices: Curriculum and Wellness Interventions to Decrease Childhood Obesity in Fifth-Graders.","OBJECTIVE To evaluate Food, Health, & Choices, two 10-month interventions. DESIGN Cluster-randomized, controlled study with 4 groups: curriculum, wellness, curriculum plus wellness, and control. SETTING Twenty elementary schools (5/group) in New York City. PARTICIPANTS Fifth-grade students (n = 1,159). At baseline, 44.6% were at the ≥85th body mass index (BMI) percentile for age and 86% qualified for free or reduced-price lunch. INTERVENTION Curriculum was 23 science lessons based on social cognitive and self-determination theories, replacing 2 mandated units. Wellness was classroom food policy and physical activity bouts of Dance Breaks. MAIN OUTCOME MEASURES For obesity, age- and sex-specific BMI percentiles were used (anthropometric measures). The researchers also employed 6 energy balance-related behaviors and 8 theory-based determinants of behavior change (by questionnaire). ANALYSIS Pairwise adjusted odds in hierarchical logistic regression models were determined for >85th BMI percentile. Behaviors and theory-based determinants were examined in a 2-level hierarchical linear model with a 2 × 2 design for intervention effects and interactions. RESULTS Obesity showed no change. For behaviors, there was a negative curriculum intervention change in physical activity (P = .04). The wellness intervention resulted in positive changes for sweetened beverages frequency (P = .05) and size (P = .006); processed packaged snacks size (P = .01); candy frequency (P = .04); baked good frequency (P = .05); and fast food frequency (P = .003), size (P = .01), and combo meals (P = .002). Theory-based determinants demonstrated no change. CONCLUSIONS AND IMPLICATIONS The findings of the lack of a decrease in obesity, behavior changes only for the wellness intervention, and no changes in theory-based determinants warrant further research.",2019,"The wellness intervention resulted in positive changes for sweetened beverages frequency (P = .05) and size (P = .006); processed packaged snacks size (P = .01); candy frequency (P = .04); baked good frequency (P = .05); and fast food frequency (P = .003), size (P = .01), and combo meals (P = .002).","['Fifth-Graders', 'Twenty elementary schools (5/group) in New York City', 'Fifth-grade students (n\u202f=\u202f1,159']","['curriculum, wellness, curriculum plus wellness, and control']","['For obesity, age- and sex-specific BMI percentiles', 'candy frequency', 'combo meals', 'obesity, behavior changes', 'packaged snacks size', 'fast food frequency', 'physical activity']","[{'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0006855', 'cui_str': 'Confection'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0159035,"The wellness intervention resulted in positive changes for sweetened beverages frequency (P = .05) and size (P = .006); processed packaged snacks size (P = .01); candy frequency (P = .04); baked good frequency (P = .05); and fast food frequency (P = .003), size (P = .01), and combo meals (P = .002).","[{'ForeName': 'Pamela Ann', 'Initials': 'PA', 'LastName': 'Koch', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, NY. Electronic address: pak14@tc.columbia.edu.'}, {'ForeName': 'Isobel R', 'Initials': 'IR', 'LastName': 'Contento', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Heewon L', 'Initials': 'HL', 'LastName': 'Gray', 'Affiliation': 'College of Public Health, University of South Florida, FL.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Burgermaster', 'Affiliation': 'Department of Nutritional Sciences, Department of Population Health, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bandelli', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Abrams', 'Affiliation': 'Department of Health and Behavior Studies, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Di Noia', 'Affiliation': 'William Paterson University, Wayne, NJ.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.12.001'] 634,29952734,"Differential perceptions of a hypothetical sexual assault survivor based on race and ethnicity: Exploring victim responsibility, trauma, and need for social support.","Objective: Explore the ways in which a sample of college women interpret racially/ethnically coded vignettes to understand their perceptions of responsibility and trauma experienced by a hypothetical female sexual assault survivor and her need for social support. Participants: Convenience sample of college women ( N  = 51) attending a large, predominately white university in the Southeastern United States recruited between January and March 2013. Methods: Participants were randomly assigned one of three vignettes describing a hypothetical date rape scenario. Vignette scenarios were identical except for discrete statements coded to signify either an African American, Latina, or white female student. Participants responded to open-ended questions that gauged their interpretations of responsibility, trauma, and social support. Results: Qualitative analysis of open-ended responses revealed six overarching themes, including overt victim blaming/shaming, justification of the sexual assault, and perceived need for social support. Conclusions: Findings point to the significance of including race in discussions about and programs that address sexual assault on college campuses to ensure that all women who experience sexual violence receive the support that they need.",2019,Findings point to the significance of including race in discussions about and programs that address sexual assault on college campuses to ensure that all women who experience sexual violence receive the support that they need.,"['Differential perceptions of a hypothetical sexual assault survivor based on race and ethnicity', 'college women interpret racially/ethnically coded vignettes to understand their perceptions of responsibility and trauma experienced by a hypothetical female sexual assault survivor and her need for social support', 'Participants: Convenience sample of college women ( N \u2009=\u200951) attending a large, predominately white university in the Southeastern United States recruited between January and March 2013']",[],"['overt victim blaming/shaming, justification of the sexual assault, and perceived need for social support']","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",[],"[{'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0037438'}]",,0.0363919,Findings point to the significance of including race in discussions about and programs that address sexual assault on college campuses to ensure that all women who experience sexual violence receive the support that they need.,"[{'ForeName': 'Kaleea R', 'Initials': 'KR', 'LastName': 'Lewis', 'Affiliation': 'a Arnold School of Public Health, Health Promotion, Education, and Behavior Department , University of South Carolina , Columbia , SC , USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Robillard', 'Affiliation': 'a Arnold School of Public Health, Health Promotion, Education, and Behavior Department , University of South Carolina , Columbia , SC , USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Billings', 'Affiliation': 'a Arnold School of Public Health, Health Promotion, Education, and Behavior Department , University of South Carolina , Columbia , SC , USA.'}, {'ForeName': 'Kellee', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'b Arnold School of Public Health, Epidemiology and Biostatistics , University of South Carolina , Columbia , SC , USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2018.1472096'] 635,29979952,The effects of meal-timing on self-rated hunger and dietary inflammatory potential among a sample of college students.,"College is an important time for young adults to establish healthy eating habits since students are at risk for gaining weight during the college years. An emerging area of research is examining the effect of meal-timing, which involves the timing of food intake throughout the day, in an effort to improve satiety and bodyweight. The purpose of this study was to examine the use of meal-timing among a sample of college students and to assess what aspects from an intervention could help them to adhere to meal-timing long term. Participants were randomly assigned to either a daytime group (≤30% total kcals after 5 pm) or a nighttime group (≥50% total kcals after 5 pm). After completing the intervention, almost half of participants (49%) reported they could adhere to meal-timing long-term. Having more resources that support meal-timing are needed to help students potentially achieve a healthy weight and prevent chronic diseases.",2019,"After completing the intervention, almost half of participants (49%) reported they could adhere to meal-timing long-term.","['young adults to establish healthy eating habits since students', 'a sample of college students', 'sample of college students']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]",[],[],,0.0188391,"After completing the intervention, almost half of participants (49%) reported they could adhere to meal-timing long-term.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'a Department of Health Promotion , Education, and Behavior, Arnold School of Public Health, University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'a Department of Health Promotion , Education, and Behavior, Arnold School of Public Health, University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'b Department of Epidemiology and Biostatistics, Cancer Control and Prevention Program Arnold School of Public Health, and College of Nursing , University of South Carolina , Columbia , South Carolina , USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2018.1481074'] 636,32198638,When Testosterone Needs to be Contrasted: A Preliminary Study of Scar Prevention in Transmen Top Surgery with an Innovative Galenic Preparation.,"BACKGROUND Transmen are individuals who live a marked incongruence between the assigned gender and the experienced gender. Crucial and life-changing steps in their transition are testosterone treatment and mastectomy to remove the stigma of feminine identity. After surgery, patients' attention turns to the scars, often not aesthetically pleasant. We thus created an innovative galenic preparation for scar treatment after surgery composed by spironolactone, alfa bisabolol and silicone gel. Functional outcomes, side effects and satisfaction were assessed. METHODS For the present prospective randomized controlled study, 30 patients with similar demographic characteristics who underwent double incision mastectomy with NA grafts between February 2014 and June 2019 were selected. The treatment Group A (n = 15) was treated for 12 months with ""Top Surgery Scar go,"" the control Group B (n = 15) with silicon gel. Statistical analysis including Wilcoxon test and Kruskal-Wallis test per variable was performed. To assess satisfaction, a second Wilcoxon test was applied. RESULTS The differences between Group A and Group B were statistically significant, especially at T12 with very low p values. Satisfaction was greater in Group A (p value = 3e-4). No major side effects were noticed in Group A. CONCLUSIONS TSSgo scar innovative treatment showed long-term efficacy in comparison with silicon gel in terms of improved scar tissue texture, pigmentation, pliability and height. It is easy to set up, cost-effective and safe. Further studies are necessary to better assess efficacy and validity of TSSgo, but it appears to be promising as the new treatment of reference for scar management after top surgery in transmen. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,"TSSgo scar innovative treatment showed long-term efficacy in comparison with silicon gel in terms of improved scar tissue texture, pigmentation, pliability and height.",['30 patients with similar demographic characteristics who underwent double incision mastectomy with NA grafts between February 2014 and June 2019 were selected'],"['IV', 'Top Surgery Scar go,"" the control Group B (n\u2009=\u200915) with silicon gel', 'spironolactone, alfa bisabolol and silicone gel']","['scar tissue texture, pigmentation, pliability and height', 'Functional outcomes, side effects and satisfaction', 'cost-effective and safe', 'Wilcoxon test and Kruskal-Wallis test', 'Satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0053774', 'cui_str': 'bisabolol'}, {'cui': 'C0599034', 'cui_str': 'Silicone Gels'}]","[{'cui': 'C2004491', 'cui_str': 'Scars'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",30.0,0.0507789,"TSSgo scar innovative treatment showed long-term efficacy in comparison with silicon gel in terms of improved scar tissue texture, pigmentation, pliability and height.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tanini', 'Affiliation': 'Department of Plastic and Reconstructive Microsurgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Calabrese', 'Affiliation': 'Department of Plastic and Reconstructive Microsurgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Alessandra D', 'Initials': 'AD', 'LastName': 'Fisher', 'Affiliation': 'Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lo Russo', 'Affiliation': 'Department of Plastic and Reconstructive Microsurgery, Careggi University Hospital, Florence, Italy. giulialorusso70@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01678-2'] 637,31006303,A Modified Syringe Plunger Device Significantly Reduces Guidewire Threading Time Regardless of Experience Level or the Presence of Presbyopia.,"PURPOSE To evaluate the efficacy of a new guidewire threading instrument (GTI) in reducing guidewire threading times compared with the traditional freehand method. MATERIALS AND METHODS This prospective, controlled, single-center study recruited 100 subjects (mean age 45.2±11.3 years; 43 men) and divided them into 2 groups depending on their professional background: 50 experienced medical personnel (performed or assisted in >50 catheter-based procedures) and 50 medical personnel with no experience in endovascular techniques (inexperienced group). The threading time of both groups was recorded using the conventional freehand method and with the GTI for both 0.035- and 0.014-inch platforms. Users of eyeglasses for presbyopia were tested with and without glasses. Median values are reported with the interquartile range (IQR; Q1, Q3) in parentheses. RESULTS The mean insertion times with both the 0.035-inch and 0.014-inch guidewires in the overall study group were significantly better with the use of the GTI compared with the traditional freehand method (p<0.001). Both the experienced and the inexperienced participants improved their insertion times using the GTI with both guidewire platforms (p<0.001). The threading time with the new device was also significantly reduced (p<0.001) for both participants with presbyopia and those without. When comparing the median absolute time improvement (difference between freehand/GTI insertion times) for the 0.014-inch platform, the inexperienced group showed a greater improvement in their performance [3.52 seconds (IQR 2.76, 5.12)] compared with the experienced group [1.87 seconds (IQR 1.37, 2.66), p<0.001]. The median ""absolute time improvement"" was also significantly greater for the presbyopic group [5.75 seconds (IQR 3.14, 8.20)] vs the group without age-related visual impairment [2.64 seconds (IQR 1.65, 3.36), p<0.001]. CONCLUSION This simple and inexpensive homemade device facilitates wire threading of low-profile catheters and seems to be especially helpful for trainees with no experience and presbyopic operators.",2019,Both the experienced and the inexperienced participants improved their insertion times using the GTI with both guidewire platforms (p<0.001).,['100 subjects (mean age 45.2±11.3 years; 43 men'],"['professional background: 50 experienced medical personnel (performed or assisted in >50 catheter-based procedures) and 50 medical personnel with no experience in endovascular techniques (inexperienced group', 'Modified Syringe Plunger Device', 'new guidewire threading instrument (GTI']","['threading time with the new device', 'Median values', 'median ""absolute time improvement', 'mean insertion times']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2936204', 'cui_str': 'Endovascular Techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0165979', 'cui_str': 'serotonin-O-carboxymethyl-Gly-Tyr'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439546', 'cui_str': 'Absolute times (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",100.0,0.0412905,Both the experienced and the inexperienced participants improved their insertion times using the GTI with both guidewire platforms (p<0.001).,"[{'ForeName': 'August', 'Initials': 'A', 'LastName': 'Ysa', 'Affiliation': '1 Department of Vascular Surgery, Hospital de Cruces, Barakaldo, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lobato', 'Affiliation': '1 Department of Vascular Surgery, Hospital de Cruces, Barakaldo, Spain.'}, {'ForeName': 'Ederi', 'Initials': 'E', 'LastName': 'Mikelarena', 'Affiliation': '2 Department of Vascular Surgery, Hospital Donostia, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Arruabarrena', 'Affiliation': '1 Department of Vascular Surgery, Hospital de Cruces, Barakaldo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gómez', 'Affiliation': '1 Department of Vascular Surgery, Hospital de Cruces, Barakaldo, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'de Blas', 'Affiliation': '2 Department of Vascular Surgery, Hospital Donostia, Spain.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Metcalfe', 'Affiliation': '3 Department of Vascular Surgery, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Fonseca', 'Affiliation': '1 Department of Vascular Surgery, Hospital de Cruces, Barakaldo, Spain.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602819844995'] 638,32178568,Influence of Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia on Intraoperative Neuromonitoring during Thyroidectomy.,"OBJECTIVE To examine the influence of sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA) on intraoperative neuromonitoring (IONM) during thyroidectomy. STUDY DESIGN A randomized controlled trial. SETTING The present study was conducted in a tertiary hospital. SUBJECTS AND METHODS Forty patients were randomly assigned to a sevoflurane-based combined intravenous and inhalation group (group S) or a propofol-based total intravenous group (group P). Anesthesia was induced with midazolam, sufentanil, propofol, and cisatracurium in both groups and was maintained with sevoflurane and remifentanil in group S and with TIVA with propofol and remifentanil in group P. IONM was performed intermittently according to the IONM formula standard. RESULTS The time until detection of the first positive electromyographic (EMG) signal was significantly longer in group S (median, 41.0 minutes [interquartile range, 37.5-49.3]) than in group P (37.0 minutes [33.3-41.5], P = .028). All patients in group P had a positive EMG signal at initial monitoring, whereas 8 patients (40.0%) in group S did not. The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006). The amplitude of the evoked potentials at V1, R1, R2, and V2 were similar between the groups. CONCLUSION Combined intravenous and inhaled anesthesia based on sevoflurane-remifentanil prolonged the time until detection of a positive EMG signal during IONM as compared with TIVA with propofol-remifentanil in patients undergoing thyroidectomy.",2020,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006).,"['The present study was conducted in a tertiary hospital', 'patients undergoing thyroidectomy', 'Forty patients']","['Sevoflurane-Based Anesthesia versus Total Intravenous Anesthesia', 'propofol-remifentanil', 'TIVA with propofol and remifentanil', 'sevoflurane-remifentanil', 'sevoflurane and remifentanil', 'sevoflurane-based combined intravenous and inhalation group', 'propofol-based total intravenous group', 'sevoflurane-based combined intravenous and inhaled anesthesia versus propofol-based total intravenous anesthesia (TIVA', 'midazolam, sufentanil, propofol, and cisatracurium']","['time until detection of the first positive electromyographic (EMG) signal', 'intraoperative neuromonitoring (IONM', 'rate of positive EMG signal at initial monitoring', 'time until detection of a positive EMG signal', 'positive EMG signal']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",40.0,0.03895,The rate of positive EMG signal at initial monitoring was significantly higher in group P than in group S ( P = .006).,"[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Head and Neck Surgery, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Jiaonan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Anesthesiology, Peking University Cancer Hospital & Institute, Beijing, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820912030'] 639,31370913,Dysregulated Irritability as a Window on Young Children's Psychiatric Risk: Transdiagnostic Effects via the Family Check-Up.,"Building on prior work using Tom Dishion's Family Check-Up, the current article examined intervention effects on dysregulated irritability in early childhood. Dysregulated irritability, defined as reactive and intense response to frustration, and prolonged angry mood, is an ideal marker of neurodevelopmental vulnerability to later psychopathology because it is a transdiagnostic indicator of decrements in self-regulation that are measurable in the first years of life that have lifelong implications for health and disease. This study is perhaps the first randomized trial to examine the direct effects of an evidence- and family-based intervention, the Family Check-Up (FCU), on irritability in early childhood and the effects of reductions in irritability on later risk of child internalizing and externalizing symptomatology. Data from the geographically and sociodemographically diverse multisite Early Steps randomized prevention trial were used. Path modeling revealed intervention effects on irritability at age 4, which predicted lower externalizing and internalizing symptoms at age 10.5. Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology. This holds promise for earlier identification and prevention approaches that target transdiagnostic pathways. Implications for future basic and prevention research are discussed.",2019,Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology.,"[""Young Children's Psychiatric Risk"", 'early childhood']","['evidence- and family-based intervention, the Family Check-Up (FCU']","['Dysregulated Irritability', 'Dysregulated irritability', 'early childhood irritability and later risk for psychopathology']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0173004,Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology.,"[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology for Drug Abuse and HIV, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Wakschlag', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Krogh-Jespersen', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Department of Psychiatry and Behavioral Sciences, Division of Child & Adolescent Psychiatry, Feinberg School of Medicine, Institute for Innovations in Developmental Sciences, Northwestern University, & Ann & Robert H. Lurie Children's Hospital.""}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Department of Psychology, Arizona State University & Oregon Research Institute.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}]",Development and psychopathology,['10.1017/S0954579419000816'] 640,31529104,Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial.,"OBJECTIVE Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy. DESIGN Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120). METHODS We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups. RESULTS The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164). CONCLUSIONS Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.",2020,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164). ",['Participants with chronic back pain or hip or knee osteoarthritis pain'],"['opioid vs nonopioid medication therapy', 'opioid vs nonopioid treatment', 'opioid therapy (N\u2009=\u2009120) or nonopioid medication therapy (N\u2009=\u2009120']","['pain outcomes', 'sleep disturbance', 'Higher sleep disturbance scores', 'Brief Pain Inventory (BPI) interference', 'pain response', 'BPI severity', 'pain outcomes and 2) test baseline sleep disturbance scores']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.122586,"Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164). ","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Koffel', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Allyson M', 'Initials': 'AM', 'LastName': 'Kats', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gravely', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'DeRonne', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Melvin T', 'Initials': 'MT', 'LastName': 'Donaldson', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Goldsmith', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz221'] 641,32193541,"Utility of major basic protein, eotaxin-3, and mast cell tryptase staining for prediction of response to topical steroid treatment in eosinophilic esophagitis: analysis of a randomized, double-blind, double dummy clinical trial.","Inflammatory factors in eosinophilic esophagitis (EoE), including major basic protein (MBP), eotaxin-3 (EOT3) and mast cell tryptase (TRP), may predict treatment response to topical corticosteroids (tCS). We aimed to determine whether baseline levels of these markers predict response to tCS for EoE. To do this, we analyzed data from a randomized trial comparing two topical steroids for treatment of newly diagnosed EoE (NCT02019758). A pretreatment esophageal biopsy was stained for MBP, EOT3, and TRP to quantify tissue biomarker levels (cells/mm2). Levels were compared between histologic responders (<15 eos/hpf) and nonresponders (the primary outcome), and endoscopic responders (EREFS<2) and nonresponders. Complete histologic response (<1 eos/hpf) was also assessed, and area under the receiver operator characteristic curve (AUC) was calculated. We also evaluated whether baseline staining predicted symptom relapse in the trial's off-treatment observation phase. Baseline samples were evaluable in 110/111 subjects who completed the randomized trial. MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different. The combination of all three stains had an AUC of 0.66 to predict response. For complete histologic response, baseline TRP levels were higher in nonresponders (n = 69) than responders (370 vs. 268 mast cells/mm2; P = 0.01), with an AUC of 0.65. The AUC for endoscopic response was 0.68. Baseline staining did not predict symptom recurrence after remission. Pretreatment MBP, EOT3, and TRP levels were not strongly or consistently associated with histologic or endoscopic response to topical steroids. While elevated TRP levels may be associated with nonresponse compared with complete response, the magnitude and predictive utilities were modest. Novel methods for predicting steroid response are still required.",2020,"MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different.","['eosinophilic esophagitis', 'Baseline samples were evaluable in 110/111 subjects who completed the randomized trial']","['major basic protein, eotaxin-3, and mast cell tryptase staining', 'topical steroids']","['MBP levels', 'major basic protein (MBP), eotaxin-3 (EOT3) and mast cell tryptase (TRP', 'elevated TRP levels', 'Complete histologic response', 'Pretreatment MBP, EOT3, and TRP levels', 'EOT3 and TRP levels', 'complete histologic response, baseline TRP levels']","[{'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1704347', 'cui_str': 'Mast Cell Tryptase'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4476471', 'cui_str': 'Chemokine CCL26'}, {'cui': 'C1704347', 'cui_str': 'Mast Cell Tryptase'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}]",,0.426272,"MBP levels were higher in nonresponders (n = 36) than responders (704 vs. 373 cells/mm2; P = 0.007), but EOT3 and TRP levels were not statistically different.","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine; University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'McGee', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Moist', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Shaheen', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doaa003'] 642,32186940,Intravitreal Conbercept Injection as an Adjuvant in Vitrectomy with Silicone Oil Infusion for Severe Proliferative Diabetic Retinopathy.,"Purpose: To assess the clinical effects of preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods: Ninety-eight eyes of 98 severe PDR patients undergoing vitrectomy with silicone oil tamponade were randomly assigned to 3 groups: Group 1 (34 eyes) received IVC injections 3 to 5 days before surgery; Group 2 (35 eyes) received IVC injections at the end of surgery; and Group 3 (29 eyes) received IVC injections 3 to 5 days before and at the end of operation. Follow-up examinations were performed for 6 months. Results: The incidence and severity of intraoperative bleeding were not significantly different ( P  = 0.233). However, the duration of surgery was significantly shorter in Group 1 and Group 3 compared with Group 2 ( P  < 0.001). The incidences of early and late recurrent vitreous hemorrhage (VH) were 32.35%, 28.57%, and 13.80%, respectively. At 6-month follow-up, mean best-corrected visual acuity had significantly increased to 1.25 ± 0.45 logMAR in Group 1, 1.29 ± 0.46 logMAR in Group 2, 1.16 ± 0.44 logMAR in Group 3 (all P  < 0.001). The incidence of postoperative VH, neovascular glaucoma, and retinal detachment in Group 3 was slightly lower, however, no significant differences were observed (all P  > 0.05). In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037). Conclusions: Preoperative IVC injection could be a safe and effective adjunct in pars plana vitrectomy with silicone oil tamponade for severe PDR. Preoperative combined with intraoperative IVC are promising, especially in young patients.",2020,"In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037). ","['young patients', 'severe proliferative diabetic retinopathy (PDR', 'Ninety-eight eyes of 98 severe PDR patients undergoing', 'Severe Proliferative Diabetic Retinopathy']","['vitrectomy with silicone oil tamponade', 'Intravitreal Conbercept Injection', 'preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade', 'Preoperative combined with intraoperative IVC', 'IVC injections', 'Silicone Oil Infusion']","['mean best-corrected visual acuity', 'visual improvements', 'incidence of postoperative VH, neovascular glaucoma, and retinal detachment', 'incidence and severity of intraoperative bleeding', 'incidences of early and late recurrent vitreous hemorrhage (VH', 'duration of surgery']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0017609', 'cui_str': 'Glaucoma, Neovascular'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",98.0,0.029451,"In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037). ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongjing', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jili', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Shibei Hospital of Jingan District, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0149'] 643,32188310,Transition of care of stable ischaemic heart disease patients from tertiary to primary care with telemedicine support: Randomized noninferiority clinical trial.,"INTRODUCTION Evidence of telehealth for chronic disease management is scarce and contradictory. OBJECTIVES We aimed to evaluate the safety and efficacy of teleconsultations as support in the care transition of patients with stable coronary artery disease (CAD) from tertiary to primary care. METHODS A randomized noninferiority clinical trial was undertaken in patients with CAD from a tertiary hospital in a middle-income country. Patients with functional angina class 1 or 2 and meeting discharge criteria were randomized to remain in the cardiology outpatient clinic for 12 months (control group, CG) or continue follow-up in a primary care unit with clinical support via telemedicine (intervention group, IG). The primary outcome was the maintenance of the functional angina class after 12 months. Secondary outcomes included control of risk factors and clinical outcomes. RESULTS In total 271 patients (mean age, 66 years) were included; 81.1% and 91% of the IG and CG, respectively, maintained stable angina symptoms, thus noninferiority could not be shown between the groups. Regarding emergency room visits at 1 year, the IG (7.6%) was noninferior to the CG (6.0%) (absolute difference, 1.6%; noninferiority margin (NIM), -4.8% to 8.2%). For control of risk factors, 30.7% and 29.6% of the IG and CG, respectively, had blood pressure <130/80 mmHg (absolute difference, 1.1%; NIM, -10.5% to 12.8%), and 48.9% and 33.3% of diabetic patients in the IG and CG, respectively, had glycated haemoglobin <7% (absolute difference, 15.6%; NIM, -6.8% to 36%). CONCLUSIONS In our study, the difference in the patients' angina functional class did not result in greater seeking of emergency care, supporting that discharge from the outpatient clinic with telemedicine is safe for patients with stable CAD treated at the tertiary level. The control of risk factors in these patients was noninferior to patients followed up in primary care. ClinicalTrials.gov (NCT02489565).",2020,,['stable ischaemic heart disease patients from tertiary to primary care with telemedicine support'],[],[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],[],,0.166239,,"[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Ruschel', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Dimitris Rv', 'Initials': 'DR', 'LastName': 'Rados', 'Affiliation': 'Hospital de Clínicas de Porto Alegre - HCPA.'}, {'ForeName': 'Mariana V', 'Initials': 'MV', 'LastName': 'Furtado', 'Affiliation': 'Hospital de Clínicas de Porto Alegre - HCPA.'}, {'ForeName': ""Joanna d'Arc L"", 'Initials': 'JDL', 'LastName': 'Batista', 'Affiliation': 'Federal University of Fronteira Sul (Universidade Federal da Fronteira Sul - UFFS).'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Erno', 'Initials': 'E', 'LastName': 'Harzheim', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}, {'ForeName': 'Carisi A', 'Initials': 'CA', 'LastName': 'Polanczyk', 'Affiliation': 'Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).'}]",Journal of telemedicine and telecare,['10.1177/1357633X20906648'] 644,32182123,The effect of acute dual SGLT1/SGLT2 inhibition on incretin release and glucose metabolism after gastric bypass surgery.,"Enhanced meal-related enteroendocrine secretion, particularly of glucagon-like peptide-1 (GLP-1), contributes to weight-loss and improved glycemia after Roux-en-Y gastric bypass (RYGB). Dietary glucose drives GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) secretion postoperatively. Understanding how glucose triggers incretin secretion following RYGB could lead to new treatments of diabetes and obesity. In vitro, incretin release depends on glucose absorption via sodium-glucose cotransporter 1 (SGLT1). We investigated the importance of SGLT1/SGLT2 for enteropancreatic hormone concentrations and glucose metabolism after RYGB in a randomized, controlled, crossover study. Ten RYGB-operated patients ingested 50 g of oral glucose with and without acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin. Paracetamol and 3- O -methyl-d-glucopyranose (3-OMG) were added to the glucose drink to evaluate rates of intestinal entry and absorption of glucose, respectively. Blood samples were collected for 4 h. The primary outcome was 4-h plasma GLP-1 (incremental area-under the curve, iAUC). Secondary outcomes included glucose, GIP, insulin, and glucagon. Canagliflozin delayed glucose absorption (time-to-peak 3-OMG: 50 vs. 132 min, P < 0.01) but did not reduce iAUC GLP-1 (6,067 vs. 7,273·min·pmol -1 ·L -1 , P = 0.23), although peak GLP-1 concentrations were lowered (-28%, P = 0.03). Canagliflozin reduced GIP (iAUC -28%, P = 0.01; peak concentrations -57%, P < 0.01), insulin, and glucose excursions, whereas plasma glucagon (AUC 3,216 vs. 4,160 min·pmol·L -1 , P = 0.02) and amino acids were increased. In conclusion, acute SGLT1/SGLT2-inhibition during glucose ingestion did not reduce 4-h plasma GLP-1 responses in RYGB-patients but attenuated the early rise in GLP-1, GIP, and insulin, whereas late glucagon concentrations were increased. The results suggest that SGLT1-mediated glucose absorption contributes to incretin hormone secretion after RYGB.",2020,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.",['gastric bypass surgery'],"['acute dual SGLT1/SGLT2 inhibition', 'oral glucose ± acute pretreatment with 600 mg of the SGLT1/SGLT2-inhibitor canagliflozin', 'Paracetamol and 3-O-methyl-D-glucopyranose (3-OMG', 'SGLT1/SGLT2']","['4-h plasma GLP-1 (incremental area-under-the-curve, iAUC', '4-h plasma GLP-1 responses', 'peak GLP-1 concentrations', 'Blood samples', 'incretin release and glucose metabolism', 'glucose absorption via sodium-glucose cotransporter-1 (SGLT1', 'Canagliflozin delayed glucose absorption', 'iAUC GLP-1', 'insulin and glucose excursions', 'plasma glucagon', 'late glucagon concentrations', 'Canagliflozin reduced GIP', 'weight-loss and improved glycemia', 'glucose, GIP, insulin and glucagon', 'amino acids']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0248805', 'cui_str': 'Sodium-Glucose Transporter 1'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]",10.0,0.0401356,"Canagliflozin reduced GIP (iAUC -28%, p=0.01; peak concentrations -57%, p<0.01), insulin and glucose excursions, whereas plasma glucagon (AUC 3216 vs. 4160 min∙pmol/l, p=0.02) and amino acids were increased.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Martinussen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Veedfald', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirstine N', 'Initials': 'KN', 'LastName': 'Bojsen-Møller', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Svane', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Viggo B', 'Initials': 'VB', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Surgical Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Clinical Biochemistry, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00023.2020'] 645,30232538,Adherence to osteoporosis therapy after an upper extremity fracture: a pre-specified substudy of the C-STOP randomized controlled trial.,"Despite their proven efficacy for secondary fracture prevention, long-term adherence with oral bisphosphonates is poor. INTRODUCTION To compare the effectiveness of two interventions on long-term oral bisphosphonate adherence after an upper extremity fragility fracture. METHODS Community-dwelling participants 50 years or older with upper extremity fragility fractures not previously treated with bisphosphonates were randomized to either a multi-faceted patient and physician educational intervention (the active control arm) vs. a nurse-led case manager (the study arm). Primary outcome was adherence (taking > 80% of prescribed doses) with prescribed oral bisphosphonates at 12 months postfracture between groups; secondary outcomes included rates of primary non-adherence and 24-month adherence. We also compared quality of life between adherent and non-adherent patients. RESULTS By 12 months, adherence with the initially prescribed bisphosphonate was similar (p = 0.96) in both groups: 38/48 (79.2%) in the educational intervention group vs. 66/83 (79.5%) in the case manager arm. By 24 months, adherence rates were 67% (32/48) in the educational intervention group vs. 53% (43/81) in case managed patients (p = 0.13). Primary non-adherence was 6% (11 patients) in the educational intervention group and 12% (21 patients) in the case managed group (p = 0.07). Prior family history of osteoporosis (aOR 2.1, 95% CI 1.0 to 4.4) and being satisfied with current medical care (aOR 2.3, 95% CI 1.1 to 4.8) were associated with better adherence while lower income (aOR 0.2, 95% CI 0.1 to 0.6, for patients with income < $30,000 per annum) was associated with poorer rates of adherence. There were no differences in health-related quality of life scores at baseline or during follow-up between patients who were adherent and those who were not. CONCLUSION While both interventions achieved higher oral bisphosphonate adherence compared to previously reported adherence rates in the general population, primary non-adherence and long-term adherence to bisphosphonates were similar in both arms. Adherence was influenced by family history of osteoporosis, satisfaction with current medical care, and income. TRIAL REGISTRATION ClinicalTrials.gov : NCT01401556.",2019,"By 24 months, adherence rates were 67% (32/48) in the educational intervention group vs. 53% (43/81) in case managed patients (p = 0.13).",['Community-dwelling participants 50\xa0years or older with upper extremity fragility fractures not previously treated with'],"['multi-faceted patient and physician educational intervention (the active control arm) vs. a nurse-led case manager', 'bisphosphonates', 'bisphosphonate', 'osteoporosis therapy']","['rates of primary non-adherence and 24-month adherence', 'adherence rates', 'quality of life', 'adherence (taking >\u200980% of prescribed doses) with prescribed\xa0oral bisphosphonates', 'higher oral bisphosphonate adherence', 'adherence', 'health-related quality of life scores']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302113', 'cui_str': 'Fragility, function (observable entity)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.155647,"By 24 months, adherence rates were 67% (32/48) in the educational intervention group vs. 53% (43/81) in case managed patients (p = 0.13).","[{'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'McAlister', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada. Finlay.McAlister@ualberta.ca.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Rowe', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bellerose', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hassan', 'Affiliation': 'EPICORE Centre, Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-018-4702-7'] 646,30244369,The risk of subsequent osteoporotic fractures is decreased in subjects experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies.,"This post-hoc analysis queried whether women experiencing fracture on denosumab indicates inadequate treatment response or whether the risk of subsequent fracture remains low with continuing denosumab. Results showed that denosumab decreases the risk of subsequent fracture and fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response. INTRODUCTION This analysis assessed whether a fracture sustained during denosumab therapy indicates inadequate treatment response and if the risk of a subsequent fracture decreases with continuing denosumab treatment. METHODS In FREEDOM, a clinical trial to evaluate the efficacy and safety of denosumab, postmenopausal women with osteoporosis were randomized to placebo or denosumab for 3 years. In the 7-year FREEDOM Extension, all participants were allocated to receive denosumab. Here we compare subsequent osteoporotic fracture rates between denosumab-treated subjects during FREEDOM or the Extension and placebo-treated subjects in FREEDOM. RESULTS During FREEDOM, 438 placebo- and 272 denosumab-treated subjects had an osteoporotic fracture. Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1). Combining all subjects on denosumab from FREEDOM and the Extension for up to 10 years (combined denosumab), 794 (13.7%) had an osteoporotic fracture while on denosumab. Of these, one or more subsequent fractures occurred in 144 (18.1%) subjects, with an exposure-adjusted incidence of 5.8 per 100 subject-years, similar to FREEDOM denosumab (6.7 per 100 subject-years) and lower than FREEDOM placebo (10.1 per 100 subject-years). Adjusting for prior fracture, the risk of having a subsequent on-study osteoporotic fracture was lower in the combined denosumab group vs placebo (hazard ratio [95% CI]: 0.59 [0.43-0.81]; P = 0.0012). CONCLUSIONS These data demonstrate that denosumab decreases the risk of subsequent fracture and a fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response.",2019,Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1).,"['postmenopausal women with osteoporosis', 'subjects experiencing fracture while on']","['denosumab-treated subjects during FREEDOM or the Extension and placebo', 'placebo', 'placebo or denosumab', 'denosumab therapy', 'denosumab']","['osteoporotic fracture rates', 'osteoporotic fracture', 'risk of having a subsequent on-study osteoporotic fracture', 'efficacy and safety', 'risk of subsequent fracture and fracture sustained', 'subsequent fractures']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy (procedure)'}]","[{'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",,0.0698668,Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1).,"[{'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada. davidkendler@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Brandi', 'Affiliation': 'University of Florence, Florence, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Papapoulos', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Lewiecki', 'Affiliation': 'New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'University of Liège, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Muñoz Torres', 'Affiliation': 'Hospital Universitario San Cecilio, Granada, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, Detroit, MI, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-018-4687-2'] 647,31493775,Longer duration of kangaroo care improves neurobehavioral performance and feeding in preterm infants: a randomized controlled trial.,"AIM To investigate the effect of kangaroo care (KC) and its duration on neurobehavioral performance, stress response, breastfeeding success, and vital signs in premature infants. METHODS One hundred and twenty premature infants were randomized to receive either KC for 60 min daily, KC for 120 min daily or conventional care (controls) for at least 7 days. Salivary cortisol was measured before and after the first KC session and then after 7 days. Temperature, respiration rate, heart rate, and oxygen saturation were recorded, before and after KC. Neonates were evaluated by the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS). RESULTS Both KC groups demonstrated higher scores for attention, arousal, regulation, nonoptimal reflexes, and quality of movements and lower scores for handling, excitability, and lethargy, compared to controls (p < 0.05). Both KC groups had higher infant breastfeeding assessment tool score and reached full enteral feeds faster than controls (p < 0.05). After the first KC session, improvement in O 2 saturation and temperature was observed in KC 120-min group compared with the KC 60-min group (p < 0.05). Salivary cortisol decreased in both KC groups compared with controls after 7 days (p < 0.05). CONCLUSION Preterm neonates who receive KC for long durations reach full enteral feeds faster, have better breastfeeding success, neurobehavioral performance, thermal control, and tissue oxygenation.",2020,Both KC groups had higher infant breastfeeding assessment tool score and reached full enteral feeds faster than controls (p < 0.05).,"['premature infants', 'One hundred and twenty premature infants', 'preterm infants']","['KC', 'kangaroo care', 'KC for 60\u2009min daily, KC for 120\u2009min daily or conventional care (controls', 'kangaroo care (KC']","['neurobehavioral performance and feeding', 'neurobehavioral performance, stress response, breastfeeding success, and vital signs', 'Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS', 'higher scores for attention, arousal, regulation, nonoptimal reflexes, and quality of movements and lower scores for handling, excitability, and lethargy', 'breastfeeding success, neurobehavioral performance, thermal control, and tissue oxygenation', 'Temperature, respiration rate, heart rate, and oxygen saturation', 'Salivary cortisol', 'higher infant breastfeeding assessment tool score', 'improvement in O 2 saturation and temperature']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0262705', 'cui_str': 'Kangaroo care (regime/therapy)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0518766'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",120.0,0.0590318,Both KC groups had higher infant breastfeeding assessment tool score and reached full enteral feeds faster than controls (p < 0.05).,"[{'ForeName': 'Rania A', 'Initials': 'RA', 'LastName': 'El-Farrash', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Shinkar', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. dinashinkar@med.asu.edu.eg.'}, {'ForeName': 'Dina A', 'Initials': 'DA', 'LastName': 'Ragab', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ramy M', 'Initials': 'RM', 'LastName': 'Salem', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Wessam E', 'Initials': 'WE', 'LastName': 'Saad', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Farag', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Dina H', 'Initials': 'DH', 'LastName': 'Salama', 'Affiliation': 'National Center for Radiation Research and Technology, Atomic Energy Authority, Cairo, Egypt.'}, {'ForeName': 'Medhat F', 'Initials': 'MF', 'LastName': 'Sakr', 'Affiliation': 'Ministry of Health, Cairo, Egypt.'}]",Pediatric research,['10.1038/s41390-019-0558-6'] 648,32057841,"The role of memory ability, depth and mode of recall in the impact of memory on later consumption.","It has been shown that recalling a meal eaten a few hours earlier (vs. the previous day) leads to reduced snacking ('meal-recall' effect). This study attempted to replicate this effect, by assessing participants' (N = 77, mean age = 33.30 [SD = 14.98], mean BMI = 23.77 [SD = 3.72], 74% female) biscuit consumption during a bogus taste test in two separate sessions, before which participants recalled a recent or a distant meal. It was explored whether factors that might affect the quality of a meal-memory, particularly individual differences in memory ability and depth of recall, would influence the meal-recall effect. To this end, only participants with a low or high memory ability were recruited for the study and were allocated to either an unguided-recall or guided-recall condition. In the unguided condition, participants were asked to recall what they ate, and in the guided condition they were prompted for further details regarding their meal. Participants were asked to either recall their meal out loud through an interview with the experimenter or by writing their recollection down on the computer. Contrary to the initial hypotheses, it was found that only the written group demonstrated the meal-recall effect, whereas the verbal group did not. Moreover, this was specific to the written, unguided group, in which participants ate about 9 g fewer biscuits after recalling a recent (vs. a distant) meal, F (1,15) = 6.07, p = .026, η p 2  = 0.288. The written, guided group's snacking seemed to increase by about 8 g after recalling a recent (vs. a distant) meal, F (1,20) = 7.31, p = .014, η p 2  = 0.268. The meal-recall effect was not evident in the verbal group. Memory ability did not influence the magnitude of the meal-recall effect. The results highlight the importance of contextual factors in modulating the meal-recall effect.",2020,Memory ability did not influence the magnitude of the meal-recall effect.,"[""participants' (N\xa0=\xa077, mean age\xa0"", 'participants with a low or high memory ability', '33.30']","['unguided-recall or guided-recall condition', 'recall their meal out loud through an interview with the experimenter or by writing their recollection down on the computer']",['meal-recall effect'],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0214141,Memory ability did not influence the magnitude of the meal-recall effect.,"[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Szypula', 'Affiliation': 'Department of Psychology, University of Cambridge, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cheke', 'Affiliation': 'Department of Psychology, University of Cambridge, UK. Electronic address: lgc23@cam.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104628'] 649,32057842,Sweet satiation: Acute effects of consumption of sweet drinks on appetite for and intake of sweet and non-sweet foods.,"Sensory-specific satiety (SSS) describes a reduction in the pleasantness of the taste of (momentary liking) and desire to consume a food that occurs with eating, compared with the relative preservation of liking and desire for uneaten foods. We conducted three studies in healthy female and male participants to test whether SSS generalises from sweet drinks to sweet foods. Studies 1 (n = 40) and 2 (n = 64) used a two-condition cross-over design. Participants consumed non-carbonated, fruit squash drinks sweetened with low-calorie sweeteners (LCS) versus water and evaluated various food and drink samples (stimuli). Generalisation of SSS was evident across all sweet stimuli, without having an effect on non-sweet (savoury) stimuli. These SSS effects were present when measured shortly after consumption of the sweet drink, but not 2 h later. There was no evidence of a 'rebound' increase above baseline in liking or desire to consume sweet foods 2 h after the sweet drink versus water. In study 3, 51 participants consumed labelled and branded 500 ml cola and water drinks (4 conditions, cross-over design) immediately before and during ad libitum consumption of sweet and non-sweet snack foods. Compared with still water, 'diet' (LCS-sweetened) cola reduced sweet food intake, but not total ad libitum intake. Carbonated water decreased hunger and increased fullness compared with still water, without differentially affecting thirst. Energy compensation from the ad libitum snacks for consumption of sugar-containing cola averaged only 20%. Together, these results demonstrate that consumption of LCS drinks acutely decreases desire for sweet foods, which supports their use in place of sugar-sweetened drinks. Further studies on the effects of carbonation of appetite are warranted.",2020,"Generalisation of SSS was evident across all sweet stimuli, without having an effect on non-sweet (savoury) stimuli.","['healthy female and male participants to test whether SSS generalises from sweet drinks to sweet foods', '51 participants']","['consumed labelled and branded 500\xa0ml cola and water drinks (4 conditions, cross-over design) immediately before and during ad libitum consumption of sweet and non-sweet snack foods', 'Sensory-specific satiety (SSS', 'non-carbonated, fruit squash drinks sweetened with low-calorie sweeteners (LCS) versus water and evaluated various food and drink samples (stimuli', 'consumption of sweet drinks']",['hunger and increased fullness'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0453865', 'cui_str': 'Sweet food (substance)'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0684195', 'cui_str': 'Cola'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0453863', 'cui_str': 'Snack Food'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0007026', 'cui_str': 'Carbonates'}, {'cui': 'C0452451', 'cui_str': 'Fruit squash drink (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0038998', 'cui_str': 'Sweeteners'}, {'cui': 'C0524819', 'cui_str': 'Food and Beverages'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}]",51.0,0.0875341,"Generalisation of SSS was evident across all sweet stimuli, without having an effect on non-sweet (savoury) stimuli.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK; National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, UK. Electronic address: peter.rogers@bristol.ac.uk.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ferriday', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Beyrom', 'Initials': 'B', 'LastName': 'Irani', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Julianne Ka', 'Initials': 'JK', 'LastName': 'Hei Hoi', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Clare Y', 'Initials': 'CY', 'LastName': 'England', 'Affiliation': 'National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, UK.'}, {'ForeName': 'Kimran K', 'Initials': 'KK', 'LastName': 'Bajwa', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gough', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, BS8 1TU, UK.'}]",Appetite,['10.1016/j.appet.2020.104631'] 650,32061707,Influence of front-of-pack labelling and regulated nutrition claims on consumers' perceptions of product healthfulness and purchase intentions: A randomized controlled trial.,"Mandatory front-of-pack (FOP) labelling was proposed in Canada to highlight foods with high contents of sugars, sodium and/or saturated fats, which would be displayed on labels along with the mandatory Nutrition Facts table and voluntary nutrition claims. In an online survey, participants (n = 1997) were randomized to one of four FOP labelling conditions: 1) control, 2) warning label, 3) health star rating or 4) traffic light labelling. Participants were shown four drinks (a healthier drink with or without a disease risk reduction claim, a healthier drink with or without a nutrient content claim, a less healthy drink with or without a disease risk reduction claim and a less healthy drink with or without a nutrient content claim) in random order and one at a time. Participants rated perceived product healthfulness and purchase intentions using a 7-point Likert scale. Participants could access the Nutrition Facts table while viewing labels. Results showed less healthy drinks displaying any FOP labelling were perceived as less healthy compared to the control. In healthier drinks, health star rating and traffic light labelling created a 'halo' effect, which was not observed with warning labels. Similar results were observed with purchase intentions. Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness. The effect of a nutrient content claim was not significantly different. The effect of FOP labelling and claims was mitigated for those who used the Nutrition Facts table. FOP labelling was likely helpful for consumers with different levels of health literacy. Overall, FOP labelling had significantly stronger influence than nutrition claims on consumers' perceptions; however, the effect of each FOP label varied on healthier and less healthy drinks.",2020,Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness.,"['participants (n\xa0=\xa01997', 'Participants were shown four drinks (a healthier drink with or without a disease risk reduction claim, a healthier drink with or without a nutrient content claim, a less healthy drink with or without a disease risk reduction claim and a less healthy drink with or without a nutrient content claim) in random order and one at a time', ""consumers' perceptions of product healthfulness and purchase intentions""]","['FOP labelling', 'front-of-pack labelling and regulated nutrition claims', 'FOP labelling conditions: 1) control, 2) warning label, 3) health star rating or 4) traffic light labelling']",['healthy drinks displaying any FOP labelling'],"[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",1997.0,0.0448937,Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness.,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: beatriz.francoarellano@mail.utoronto.ca.""}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada. Electronic address: lana.vanderlee@uwaterloo.ca.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mavra.ahmed@mail.utoronto.ca.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; Faculty of Law, University of Ottawa, 57 Louis Pasteur St, Ottawa, Ontario, K1N 6N5, Canada. Electronic address: yeonji.oh@mail.utoronto.ca.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mary.labbe@utoronto.ca.""}]",Appetite,['10.1016/j.appet.2020.104629'] 651,32168168,HIV Oral Self-Testing for Male Partners of Women Attending Antenatal Care in Central Uganda: Uptake of Testing and Linkage to Care in a Randomized Trial.,"BACKGROUND In Uganda, HIV testing rates are approximately 90% among women in antenatal care, with male rates much lower. The World Health Organization has recommended HIV self-testing (HIVST), and one promising model is for women in antenatal care to deliver HIVST kits to their male partners. We investigated the impact of this model on male partner testing rates. SETTING Three high-volume antenatal clinics in central Uganda. METHODS We implemented a cluster-randomized controlled trial comparing standard of care to intervention, with the primary outcome of self-reported male partner HIV testing. Women and male partners were followed at 1 and 3 months. We used unadjusted analyses and log-linear models with an intent-to-treat approach accounting for clustering. RESULTS Study coordinators randomized 1514 women (777 intervention and 737 control). Baseline characteristics were balanced across arms with mean age (SD) of 25.2 (5.5) years and >44% with secondary education or higher. More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], P < 0.01. We identified 34 HIV-positive men in intervention versus 10 in control, with 6/26 (23%) and 4/6 (67%), respectively, reporting linking to care. CONCLUSIONS Our results demonstrate an enormous increase in self-reported partner HIV testing when HIVST is available at home. However, men testing positive through HIVST appeared less likely to link to care than men testing positive at a clinic. These results highlight the potential of HIVST in increasing HIV testing rates, while underscoring the importance of developing effective approaches to maximizing linkage to care among those testing positive through HIVST.",2020,"More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], p<0.01.","['34 HIV positive men in intervention versus 10 in control, with 6/26 (23%) and 4/6 (67%), respectively, reporting linking to care', 'Women and male partners', '1,514 women (777 intervention, 737 control', 'male partners of women attending antenatal care in central Uganda', 'Three high-volume antenatal clinics in central Uganda', 'male partner testing rates']","['HIV oral self-testing', 'HIVST']",[],"[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",[],1514.0,0.147164,"More male partners tested for HIV in intervention [576/746 (77.2%)] versus control [264/709 (37.2%)], p<0.01.","[{'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Korte', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Kisa', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Vrana-Diaz', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Malek', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Buregyeya', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Joseph K B', 'Initials': 'JKB', 'LastName': 'Matovu', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kagaayi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Musoke', 'Affiliation': 'Clinical Services, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Research and Strategic Information, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Semei C', 'Initials': 'SC', 'LastName': 'Mukama', 'Affiliation': 'Research and Strategic Information, Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ndyanabo', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Shaban', 'Initials': 'S', 'LastName': 'Mugerwa', 'Affiliation': 'AIDS Control Program, Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Rhoda K', 'Initials': 'RK', 'LastName': 'Wanyenze', 'Affiliation': 'Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002341'] 652,32185497,"Invited Discussion on: A Randomized, Controlled Study Comparing Subbrow Blepharoplasty and Subbrow Blepharoplasty Combined with Periorbital Muscle Manipulation for Periorbital Aging Rejuvenation in Asians.",,2020,,['Periorbital Aging Rejuvenation in Asians'],['Subbrow Blepharoplasty and Subbrow Blepharoplasty Combined with Periorbital Muscle Manipulation'],[],"[{'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]",[],,0.0241604,,"[{'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Division of Plastic and Aesthetic Surgery, The Affiliated Friendship Plastic Surgery Hospital of Nanjing Medical University, No. 109 Nongguangli, Chaoyang District, Beijing City, 100021, China. psryuminhee@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01669-3'] 653,31958161,Interventions for chronic palmoplantar pustulosis.,"BACKGROUND Palmoplantar pustulosis is a chronic inflammatory disease in which sterile, relapsing pustules appear on the palms and soles, possibly in conjunction with other symptoms. The previous Cochrane Review on this topic was published in 2006, before biological treatments were extensively used. OBJECTIVES To assess the effects of interventions for chronic palmoplantar pustulosis to induce and maintain complete remission. SEARCH METHODS We searched the following databases up to March 2019: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of the included studies for further references to relevant randomised controlled trials (RCTs). SELECTION CRITERIA We considered RCTs including people with palmoplantar pustulosis or chronic palmoplantar pustular psoriasis assessing topical therapy, systemic therapy, combinations of topical or systemic therapies, or non-pharmacological therapies compared with placebo, no intervention, or each other. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. Our outcomes included 'Proportion of participants cleared or almost cleared', 'Proportion of participants with adverse effects serious or severe enough to cause withdrawal', 'Proportion of participants with at least 50% improvement in disease severity', and 'Proportion of participants with adverse effects'. MAIN RESULTS We included 37 studies (1663 participants; mean age 50 years (range 34 to 63); 24% males). These studies reported condition severity differently. Around half of the included trials stated the setting (hospitals, community clinics, or both). More than half of the studies were at high risk of bias in at least one domain. Our included studies assessed mainly systemic treatments (retinoids, ciclosporin, biologics, etretinate + PUVA (combination of psoralens and long-wave ultraviolet radiation) therapy combined, and antibiotics), but also topical treatments (dermocorticoids, vitamin D) and phototherapy (PUVA, ultraviolet A1 (UVA1)). Other interventions were assessed by single studies. The most common comparator was placebo. All results presented in this abstract were assessed in the short term (mean treatment duration was 11 weeks (range 8 to 24 weeks)) and are based on participants with chronic palmoplantar pustulosis. All outcome time point measurements were taken from baseline and assessed at the end of treatment. Short-term and long-term outcomes were defined as measurement up to 24 weeks after randomisation and between 24 and 104 weeks after randomisation, respectively. One trial (188 participants) assessed the topical vitamin D derivative maxacalcitol versus placebo and found that maxacalcitol may be more effective than placebo in achieving clearance (risk ratio (RR) 7.83, 95% confidence interval (CI) 1.85 to 33.12; low-quality evidence), and the risk of adverse effects (such as mild local irritation, pruritus, and haematological or urinary test abnormalities) is probably similar in both groups (RR 0.87, 95% CI 0.64 to 1.19; moderate-quality evidence). Severity was not reported. Two trials (49 participants) assessed PUVA therapy versus placebo or no treatment, providing very low-quality evidence. Adverse effects were reported with oral PUVA (including nausea, ankle swelling, and non-purulent conjunctivitis) and with local PUVA (including blistering, erythema, and pruritus). With regard to the systemic retinoid alitretinoin, one trial (33 participants; moderate-quality evidence) showed that alitretinoin probably makes little or no difference in reducing severity when compared to placebo (RR 0.69, 95% CI 0.36 to 1.30). A similar number of adverse events were reported in both treatment groups, including headache, cheilitis, nausea, arthralgia, and nasopharyngitis (RR 0.84, 95% CI 0.61 to 1.17). Clearance was not reported. There may be little or no difference between etanercept and placebo in achieving clearance (RR 1.64, 95% CI 0.08 to 34.28; 1 study; 15 participants; low-quality evidence); however, the 95% CI was very wide, showing there may be a difference between groups. Severity was not measured. More patients treated with placebo may achieve reduced severity than those treated with ustekinumab, but the wide 95% CI indicates there might be little or no difference between groups and there might be greater effect with ustekinumab (RR 0.48, 95% CI 0.11 to 2.13; 1 study; 33 participants; low-quality evidence). Clearance was not reported. It is uncertain whether guselkumab increases clearance when compared to placebo (2 studies; 154 participants) because the quality of evidence is very low, but guselkumab probably better reduces disease severity (RR 2.88, 95% CI 1.24 to 6.69; 1 study; 49 participants; moderate-quality evidence). Secukinumab is probably superior to placebo in reducing severity (RR 1.55, 95% CI 1.02 to 2.35; 1 study; 157 participants; moderate-quality evidence), but our clearance outcome was not reported. None of these trials reported on occurrence of adverse effects. Only two of the studies discussed above reported adverse effects serious or severe enough to cause withdrawal. Guselkumab may cause more serious adverse events when compared to placebo, but there is uncertainty due to the very wide 95% CI showing there may be little or no difference and showing more events with placebo (RR 2.88, 95% CI 0.32 to 25.80; 1 study; 49 participants; low-quality evidence). Secukinumab probably causes more serious adverse events than placebo (RR 3.29, 95% CI 1.40 to 7.75; 1 study; 157 participants; moderate-quality evidence). AUTHORS' CONCLUSIONS Evidence is lacking for major chronic palmoplantar pustulosis treatments such as superpotent corticosteroids, phototherapy, acitretin, methotrexate, and ciclosporin. Risk of bias and imprecision limit our confidence. Maxacalcitol may be more effective than placebo in achieving clearance in the short term (low-quality evidence), and the risk of adverse effects is probably similar (moderate-quality evidence). Oral alitretinoin is probably no more effective than placebo in reducing severity, with a similar risk of adverse effects (moderate-quality evidence). Regarding biological treatments, we are uncertain of the effect of etanercept on clearance and the effect of ustekinumab on severity (low-quality evidence). Secukinumab and guselkumab are probably superior to placebo in reducing severity (moderate-quality evidence). Adverse events not requiring withdrawal were not reported for these treatments. Reporting of serious adverse effects was incomplete: compared to placebo, secukinumab probably caused more participant withdrawals (moderate-quality evidence), but we are uncertain of the effect of guselkumab (low-quality evidence). Future trials should assess commonly used treatments using validated severity and quality of life scales.",2020,"Secukinumab is probably superior to placebo in reducing severity (RR 1.55, 95% CI 1.02 to 2.35; 1 study; 157 participants; moderate-quality evidence), but our clearance outcome was not reported.","['37 studies (1663 participants; mean age 50 years (range 34 to 63); 24% males', 'people with palmoplantar pustulosis or chronic palmoplantar pustular psoriasis', 'chronic palmoplantar pustulosis']","['placebo', 'PUVA therapy versus placebo', 'Secukinumab and guselkumab', 'etretinate + PUVA (combination of psoralens and long-wave ultraviolet radiation) therapy combined, and antibiotics', 'topical vitamin D derivative maxacalcitol versus placebo', 'RCTs', 'topical treatments (dermocorticoids, vitamin D) and phototherapy (PUVA, ultraviolet A1 (UVA1', 'etanercept', 'oral PUVA']","['achieving clearance (risk ratio (RR', 'adverse effects', 'adverse events', 'Adverse effects', 'nausea, ankle swelling, and non-purulent conjunctivitis) and with local PUVA (including blistering, erythema, and pruritus', 'mild local irritation, pruritus, and haematological or urinary test abnormalities', ""disease severity', and 'Proportion of participants with adverse effects"", 'disease severity', 'headache, cheilitis, nausea, arthralgia, and nasopharyngitis', 'risk of adverse effects', 'serious adverse events', ""Proportion of participants cleared or almost cleared', 'Proportion of participants with adverse effects serious or severe enough to cause withdrawal', 'Proportion"", 'Clearance', 'achieving clearance']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030246', 'cui_str': 'Pustulosis of Palms and Soles'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034172', 'cui_str': 'Psoralen Ultraviolet A Therapy'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0015137', 'cui_str': 'Etretinate'}, {'cui': 'C0853073', 'cui_str': 'PUVA'}, {'cui': 'C0016072', 'cui_str': 'Psoralen'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4319812', 'cui_str': 'Ultraviolet Radiation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0043872', 'cui_str': 'maxacalcitriol'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0009768', 'cui_str': 'Conjunctivitis, Mucopurulent'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0853073', 'cui_str': 'PUVA'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0007971', 'cui_str': 'Cheilitis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",1663.0,0.750782,"Secukinumab is probably superior to placebo in reducing severity (RR 1.55, 95% CI 1.02 to 2.35; 1 study; 157 participants; moderate-quality evidence), but our clearance outcome was not reported.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Obeid', 'Affiliation': 'Hôpital du Sacré Cœur, Department of Dermatology, Beirut, Lebanon.'}, {'ForeName': 'Giao', 'Initials': 'G', 'LastName': 'Do', 'Affiliation': 'Hôpital Henri Mondor, Department of Dermatology, 51 avenue du Général de Lattre de Tassigny, Créteil, France, 94010.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kirby', 'Affiliation': 'Queen Elizabeth University Hospital (The Southern General Hospital), Department of Dermatology, 1345 Govan Road, Glasgow, UK, G51 4TF.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': ""The University of Nottingham, c/o Cochrane Skin Group, A103, King's Meadow Campus, Lenton Lane, Nottingham, UK, NG7 2NR.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Sbidian', 'Affiliation': 'Hôpital Henri Mondor, Department of Dermatology, 51 avenue du Général de Lattre de Tassigny, Créteil, France, 94010.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Le Cleach', 'Affiliation': 'Hôpital Henri Mondor, Department of Dermatology, 51 avenue du Général de Lattre de Tassigny, Créteil, France, 94010.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011628.pub2'] 654,30388950,A randomized controlled trial of the effects of mindfulness practice on doctoral candidate psychological status.,"Objectives: To examine the impact of guided mindfulness practice on psychological distress and psychological capital (hope, optimism, resilience, and efficacy) in doctoral candidates. Participants: Recruitment of a convenience sample of doctoral candidates occurred in July 2015 and participants were randomly allocated to the control or intervention group (38 and 34 participants completed the trial, respectively). Methods: A single-blinded, randomized controlled trial with intention-to-treat analysis was conducted. The intervention consisted of a daily guided mindfulness practice, using an audio CD. Indicators of psychological distress and psychological capital were measured pre- and post-trial with validated questionnaires. Results: Compared to the control group, the intervention group reported a statistically significantly reduction in depression ( p  = .045) and increased self-efficacy ( p  = .004), hope ( p  = .000), and resilience ( p  = .011). Conclusions: These results highlight the effectiveness of self-administered mindfulness practice on the psychological health of doctoral candidates, and the positive effect on psychological capital is reported as a key finding.",2019,"Compared to the control group, the intervention group reported a statistically significantly reduction in depression ( p  = .045) and increased self-efficacy ( p  = .004), hope ( p  = .000), and resilience ( p  = .011). ",['Participants: Recruitment of a convenience sample of doctoral candidates occurred in July 2015 and participants'],"['guided mindfulness practice', 'mindfulness practice']","['doctoral candidate psychological status', 'depression', 'psychological distress and psychological capital (hope, optimism, resilience, and efficacy', 'self-efficacy', 'psychological distress and psychological capital']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.171538,"Compared to the control group, the intervention group reported a statistically significantly reduction in depression ( p  = .045) and increased self-efficacy ( p  = .004), hope ( p  = .000), and resilience ( p  = .011). ","[{'ForeName': 'Karen May', 'Initials': 'KM', 'LastName': 'Barry', 'Affiliation': 'a Tasmanian Institute of Agriculture , University of Tasmania , Hobart , Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Woods', 'Affiliation': 'b Tasmanian School of Business and Economics , University of Tasmania , Hobart , Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'b Tasmanian School of Business and Economics , University of Tasmania , Hobart , Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Stirling', 'Affiliation': 'c School of Health Sciences , University of Tasmania , Hobart , Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Warnecke', 'Affiliation': 'd School of Medicine , University of Tasmania , Hobart , Australia.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2018.1515760'] 655,31897524,Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial.,"AIMS/HYPOTHESIS Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. This study aimed to compare the effects of semaglutide 1.0 mg and canagliflozin 300 mg on body composition in a subset of participants from the SUSTAIN 8 Phase IIIB, randomised double-blind trial who underwent whole-body dual-energy x-ray absorptiometry (DXA) scanning. METHODS Adults (age ≥18 years) with type 2 diabetes, HbA 1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min -1 [1.73 m] -2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly. Body composition was assessed using whole-body DXA scans. The study participants and investigator remained blinded throughout the trial, and quality of DXA scans was evaluated in a blinded manner. Change from baseline to week 52 in total fat mass (kg) was the confirmatory efficacy endpoint. RESULTS A subset of 178 participants (semaglutide, n = 88; canagliflozin, n = 90) underwent DXA scanning at screening and were randomised into the substudy. Of these, 114 (semaglutide, n = 53; canagliflozin, n = 61) participants had observed end-of-treatment data included in the confirmatory efficacy analysis. Of the 178 participants in the substudy, numerical improvements in body composition (including fat mass, lean mass and visceral fat mass) were observed after 52 weeks with both treatments. Total fat mass (baseline 33.2 kg) was reduced by 3.4 kg and 2.6 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.79 [95% CI -2.10, 0.51]). Although total lean mass (baseline 51.3 kg) was also reduced by 2.3 kg and 1.5 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.78 [-1.61, 0.04]), the proportion of lean mass (baseline 59.4%) increased by 1.2%- and 1.1%-point, respectively (estimated treatment difference 0.14 [-0.89, 1.17]). Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups. CONCLUSIONS/INTERPRETATION In individuals with uncontrolled type 2 diabetes on stable-dose metformin therapy, the changes in body composition with semaglutide and canagliflozin were not significantly different. Although numerical improvements in body composition were observed following treatment in both treatment arms, the specific impact of both treatments on body composition in the absence of a placebo arm is speculative at this stage. TRIAL REGISTRATION ClinicalTrials.gov NCT03136484. FUNDING This trial was supported by Novo Nordisk A/S, Denmark.",2020,"Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups. ","['178 participants in the substudy', 'Adults (age\u2009≥18\xa0years) with type 2 diabetes, HbA 1c 53-91\xa0mmol/mol (7.0-10.5%), on a stable daily dose of', '178 participants (semaglutide, n\u2009=\u200988; canagliflozin, n\u2009=\u200990) underwent', '≥1500\xa0mg or maximum tolerated dose) and with an eGFR ≥60', 'type 2 diabetes']","['once-weekly semaglutide vs once-daily canagliflozin', 'DXA scanning at screening', 'placebo', 'semaglutide 1.0\xa0mg and canagliflozin', 'whole-body dual-energy x-ray absorptiometry (DXA) scanning', 'semaglutide 1.0\xa0mg once weekly and canagliflozin placebo once daily, or canagliflozin 300\xa0mg once daily and semaglutide placebo', 'metformin']","['proportion of lean mass', 'Total fat mass', 'body composition (including fat mass, lean mass and visceral fat mass', 'Body composition', 'total lean mass', 'visceral fat mass and overall changes in body composition', 'body composition', 'body composition with semaglutide and canagliflozin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C3556568', 'cui_str': 'canagliflozin 300 MG [Invokana]'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]",178.0,0.669445,"Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups. ","[{'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK. r.mccrimmon@dundee.ac.uk.'}, {'ForeName': 'Andrei-Mircea', 'Initials': 'AM', 'LastName': 'Catarig', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej, Søborg, Denmark.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Nanna L', 'Initials': 'NL', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej, Søborg, Denmark.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'le Roux', 'Affiliation': 'Diabetes Complications Research Centre, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Thielke', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.'}]",Diabetologia,['10.1007/s00125-019-05065-8'] 656,31915895,Oral butyrate does not affect innate immunity and islet autoimmunity in individuals with longstanding type 1 diabetes: a randomised controlled trial.,"AIMS/HYPOTHESIS The pathophysiology of type 1 diabetes has been linked to altered gut microbiota and more specifically to a shortage of intestinal production of the short-chain fatty acid (SCFA) butyrate, which may play key roles in maintaining intestinal epithelial integrity and in human and gut microbial metabolism. Butyrate supplementation can protect against autoimmune diabetes in mouse models. We thus set out to study the effect of oral butyrate vs placebo on glucose regulation and immune variables in human participants with longstanding type 1 diabetes. METHODS We administered a daily oral dose of 4 g sodium butyrate or placebo for 1 month to 30 individuals with longstanding type 1 diabetes, without comorbidity or medication use, in a randomised (1:1), controlled, double-blind crossover trial, with a washout period of 1 month in between. Participants were randomly allocated to the 'oral sodium butyrate capsules first' or 'oral placebo capsules first' study arm in blocks of five. The clinical investigator received blinded medication from the clinical trial pharmacy. All participants, people doing measurements or examinations, or people assessing the outcomes were blinded to group assignment. The primary outcome was a change in the innate immune phenotype (monocyte subsets and in vitro cytokine production). Secondary outcomes were changes in blood markers of islet autoimmunity (cell counts, lymphocyte stimulation indices and CD8 quantum dot assays), glucose and lipid metabolism, beta cell function (by mixed-meal test), gut microbiota and faecal SCFA. The data was collected at the Amsterdam University Medical Centers. RESULTS All 30 participants were analysed. Faecal butyrate and propionate levels were significantly affected by oral butyrate supplementation and butyrate treatment was safe. However, this modulation of intestinal SCFAs did not result in any significant changes in adaptive or innate immunity, or in any of the other outcome variables. In our discussion, we elaborate on this important discrepancy with previous animal work. CONCLUSIONS/INTERPRETATION Oral butyrate supplementation does not significantly affect innate or adaptive immunity in humans with longstanding type 1 diabetes. TRIAL REGISTRATION Netherlands Trial Register: NL4832 (www.trialregister.nl). DATA AVAILABILITY Raw sequencing data are available in the European Nucleotide Archive repository (https://www.ebi.ac.uk/ena/browse) under study PRJEB30292. FUNDING The study was funded by a Le Ducq consortium grant, a CVON grant, a personal ZONMW-VIDI grant and a Dutch Heart Foundation grant.",2020,"However, this modulation of intestinal SCFAs did not result in any significant changes in adaptive or innate immunity, or in any of the other outcome variables.","['All 30 participants were analysed', 'human participants with longstanding type 1 diabetes', 'humans with longstanding type 1 diabetes', 'individuals with longstanding type 1 diabetes', '30 individuals with longstanding type 1 diabetes, without comorbidity or medication use']","['Oral butyrate', 'sodium butyrate or placebo', ""oral sodium butyrate capsules first' or 'oral placebo"", 'oral butyrate vs placebo', 'Butyrate supplementation']","['change in the innate immune phenotype (monocyte subsets and in vitro cytokine production', 'Faecal butyrate and propionate levels', 'changes in blood markers of islet autoimmunity (cell counts, lymphocyte stimulation indices and CD8 quantum dot assays), glucose and lipid metabolism, beta cell function (by mixed-meal test), gut microbiota and faecal SCFA', 'adaptive or innate immunity', 'glucose regulation and immune variables', 'adaptive immunity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0142812', 'cui_str': 'Sodium Butyrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0392214', 'cui_str': 'Propionate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C0024262', 'cui_str': 'Lymphoblast Transformation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1258084', 'cui_str': 'Quantum Dots'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0020969', 'cui_str': 'Innate Immune Response'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0678209', 'cui_str': 'Acquired Immunity'}]",30.0,0.332559,"However, this modulation of intestinal SCFAs did not result in any significant changes in adaptive or innate immunity, or in any of the other outcome variables.","[{'ForeName': 'Pieter F', 'Initials': 'PF', 'LastName': 'de Groot', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands. p.f.degroot@amsterdamumc.nl.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Nikolic', 'Affiliation': 'Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Imangaliyev', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Siroon', 'Initials': 'S', 'LastName': 'Bekkering', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Duinkerken', 'Affiliation': 'Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Fleur M', 'Initials': 'FM', 'LastName': 'Keij', 'Affiliation': 'Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Herrema', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Winkelmeijer', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Evgeni', 'Initials': 'E', 'LastName': 'Levin', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hutten', 'Affiliation': 'Department of Epidemiology, Amsterdam University Medical Centers, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Elles M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Clinical Pharmacy, Amsterdam University Medical Centers, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Suat', 'Initials': 'S', 'LastName': 'Simsek', 'Affiliation': 'Department of Internal Medicine, Alkmaar Medical Center (MCA), Alkmaar, the Netherlands.'}, {'ForeName': 'Johannes H M', 'Initials': 'JHM', 'LastName': 'Levels', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Flora A', 'Initials': 'FA', 'LastName': 'van Hoorn', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Bindraban', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Berkvens', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Geesje M', 'Initials': 'GM', 'LastName': 'Dallinga-Thie', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Davids', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Holleman', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Joost B L', 'Initials': 'JBL', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Mihai', 'Initials': 'M', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart O', 'Initials': 'BO', 'LastName': 'Roep', 'Affiliation': 'Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Internal and Vascular Medicine, Academic Medical Center, Meibergdreef 9, Room D3-316, 1105 AZ, Amsterdam, the Netherlands.'}]",Diabetologia,['10.1007/s00125-019-05073-8'] 657,31919539,A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial.,"AIMS/HYPOTHESIS This randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes. METHODS The study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA 1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35-55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40-74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2-3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life. RESULTS At the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes. CONCLUSIONS/INTERPRETATION This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. TRIAL REGISTRATION The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833). FUNDING The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.",2020,"This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. ","['India and the UK in people with prediabetes', 'Participants were recruited from public and private sector organisations in India (men and women aged 35-55\xa0years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40-74\xa0years without pre-existing diabetes, cardiovascular disease or kidney disease', 'type 2 diabetes in India and the UK', 'people with prediabetes (n\u2009=\u20092062; control: n\u2009=\u20091031']","['supportive text messages using mobile phone SMS messages', 'mobile phone short message service (SMS) text messages', 'intervention: n\u2009=\u20091031) defined by HbA 1c ≥42 and ≤47\xa0mmol/mol']","['conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178909'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034380'}]",1031.0,0.155623,"This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. ","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Nanditha', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Thomson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, SW7 2AZ, UK.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Susairaj', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Weerachai', 'Initials': 'W', 'LastName': 'Srivanichakorn', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, SW7 2AZ, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Oliver', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, SW7 2AZ, UK.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Godsland', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, SW7 2AZ, UK.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Majeed', 'Affiliation': 'School of Public Health, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College, London, UK.'}, {'ForeName': 'Krishnamoorthy', 'Initials': 'K', 'LastName': 'Satheesh', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Raghavan', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Vinitha', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Chamukuttan', 'Initials': 'C', 'LastName': 'Snehalatha', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Westgate', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Box 285 Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. Nick.Wareham@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Desmond G', 'Initials': 'DG', 'LastName': 'Johnston', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, SW7 2AZ, UK. d.johnston@imperial.ac.uk.'}, {'ForeName': 'Ambady', 'Initials': 'A', 'LastName': 'Ramachandran', 'Affiliation': 'India Diabetes Research Foundation, Chennai, India. dr.ramachandran@ardiabetes.org.'}]",Diabetologia,['10.1007/s00125-019-05061-y'] 658,32164428,Headache and non-headache symptoms provoked by nitroglycerin in migraineurs: A human pharmacological triggering study.,"BACKGROUND Studying a spontaneous migraine attack is challenging, particularly the earliest components. Nitroglycerin is a potent, reliable and reproducible migraine trigger of the entirety of the migraine attack, making its use experimentally attractive. METHODS Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms were exposed to a 0.5 mcg/kg/min nitroglycerin infusion. Eighty-three percent (n = 44) developed typical premonitory and headache symptomatology. Fifty-seven percent (n = 25) were invited back to further study visits, during which they were re-exposed to nitroglycerin or placebo infusion in a double-blind randomised design. The phenotype of premonitory symptoms and headache was captured and compared to spontaneous attacks and between triggered attacks using agreement analysis. RESULTS More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4, t 20  = 7.06, p  < 0.001). The agreement in triggering for the most commonly reported premonitory symptoms (concentration difficulty and tiredness) was >66%. The retriggering agreement for all but one premonitory symptom was >60%. The agreement in timing to onset of premonitory symptoms was reliable across two triggered attacks. The agreement with spontaneous attacks and between attacks for headache and its associated symptoms, including laterality, was less reliable. CONCLUSIONS Nitroglycerin can reliably and reproducibly provoke premonitory symptomatology associated with migraine. This forms an ideal model to study the earliest manifestations of migraine attacks.",2020,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4, t 20  = 7.06, p  < 0.001).","['Eighty-three percent (n\u2009', 'migraineurs', 'Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms', 'Fifty-seven percent (n\u2009']","['nitroglycerin or placebo infusion', 'nitroglycerin infusion', 'placebo', 'Nitroglycerin', 'nitroglycerin']","['Headache', 'typical premonitory and headache symptomatology']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",53.0,0.162561,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4, t 20  = 7.06, p  < 0.001).","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jayde', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102420910114'] 659,30920983,Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: A randomised controlled trial.,"BACKGROUND Profound neuromuscular blockade (NMB) during anaesthesia has been shown to reduce postoperative pain scores, when compared with a moderate block. We hypothesised that profound NMB during laparoscopic donor nephrectomy (LDN) could also improve the early quality of recovery after surgery. OBJECTIVES To compare the effectiveness of profound versus moderate NMB during LDN in enhancing postoperative recovery. DESIGN A phase IV, double-blinded, randomised controlled trial. SETTING Multicentre trial, from November 2016 to December 2017. PATIENTS A total of 101 living kidney donors scheduled for LDN were enrolled, and 96 patients were included in the analyses. INTERVENTIONS Patients were randomised to receive profound (posttetanic count 1 to 3) or moderate (train-of-four count 1 to 3) neuromuscular block. MAIN OUTCOME MEASURES The primary outcome was the early quality of recovery at postoperative day 1, measured by the Quality of Recovery-40 Questionnaire. Secondary outcomes were adverse events, postoperative pain, analgesic consumption and length-of-stay. RESULTS The intention-to-treat analysis did not show a difference with regard to the quality of recovery, pain scores, analgesic consumption and length-of-stay. Less intra-operative adverse events occurred in patients allocated to profound NMB (1/48 versus 6/48). Five patients allocated to a profound NMB received a moderate block and in two patients neuromuscular monitoring failed. The as-treated analysis revealed that pain scores were significantly lower at 6, 24 and 48 h after surgery. Moreover, the quality of recovery was significantly better at postoperative day 2 in patients receiving a profound versus moderate block (179.5 ± 13.6 versus 172.3 ± 19.2). CONCLUSION Secondary analysis indicates that an adequately maintained profound neuromuscular block improves postoperative pain scores and quality of recovery. As the intention-to-treat analysis did not reveal a difference regarding the primary endpoint, future studies should pursue whether a thoroughly maintained profound NMB during laparoscopy improves relevant patient outcomes. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02838134.",2019,Less intra-operative adverse events occurred in patients allocated to profound NMB (1/48 versus 6/48).,"['101 living kidney donors scheduled for LDN were enrolled, and 96 patients were included in the analyses', 'Multicentre trial, from November 2016 to December 2017']","['laparoscopic donor nephrectomy', 'profound versus moderate neuromuscular blockade', 'laparoscopic donor nephrectomy (LDN', 'NMB', 'profound (posttetanic count 1 to 3) or moderate (train-of-four count 1 to 3) neuromuscular block']","['quality of recovery', 'quality of recovery, pain scores, analgesic consumption and length-of-stay', 'postoperative pain scores', 'postoperative pain scores and quality of recovery', 'adverse events, postoperative pain, analgesic consumption and length-of-stay', 'pain scores', 'early quality of recovery at postoperative day 1, measured by the Quality of Recovery-40 Questionnaire', 'Less intra-operative adverse events']","[{'cui': 'C4305252', 'cui_str': 'Live donor of kidney (person)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0428699', 'cui_str': 'Train of four count (observable entity)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",2.0,0.68067,Less intra-operative adverse events occurred in patients allocated to profound NMB (1/48 versus 6/48).,"[{'ForeName': 'Moira H D', 'Initials': 'MHD', 'LastName': 'Bruintjes', 'Affiliation': ''}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Krijtenburg', 'Affiliation': ''}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Martini', 'Affiliation': ''}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Poyck', 'Affiliation': ''}, {'ForeName': 'Frank C H', 'Initials': 'FCH', 'LastName': ""d'Ancona"", 'Affiliation': ''}, {'ForeName': 'Volkert A L', 'Initials': 'VAL', 'LastName': 'Huurman', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'van der Jagt', 'Affiliation': ''}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Langenhuijsen', 'Affiliation': ''}, {'ForeName': 'Willemijn N', 'Initials': 'WN', 'LastName': 'Nijboer', 'Affiliation': ''}, {'ForeName': 'Cornelis J H M', 'Initials': 'CJHM', 'LastName': 'van Laarhoven', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': ''}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Warlé', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000000992'] 660,30255229,Serum 25-hydroxyvitamin D levels and incident falls in older women.,"Three hundred eighty-seven home-dwelling older women were divided into quartiles based on mean serum 25-hydroxyvitamin D (S-25(OH)D) levels. The rates of falls and fallers were about 40% lower in the highest S-25(OH)D quartile compared to the lowest despite no differences in physical functioning, suggesting that S-25(OH)D levels may modulate individual fall risk. INTRODUCTION Vitamin D supplementation of 800 IU did not reduce falls in our previous 2-year vitamin D and exercise RCT in 70-80 year old women. Given large individual variation in individual responses, we assessed here effects of S-25(OH)D levels on fall incidence. METHODS Irrespective of original group allocation, data from 387 women were explored in quartiles by mean S-25(OH)D levels over 6-24 months; means (SD) were 59.3 (7.2), 74.5 (3.3), 85.7 (3.5), and 105.3 (10.9) nmol/L. Falls were recorded monthly with diaries. Physical functioning and bone density were assessed annually. Negative binomial regression was used to assess incidence rate ratios (IRRs) for falls and Cox-regression to assess hazard ratios (HR) for fallers. Generalized linear models were used to test between-quartile differences in physical functioning and bone density with the lowest quartile as reference. RESULTS There were 37% fewer falls in the highest quartile, while the two middle quartiles did not differ from reference. The respective IRRs (95% CI) for falls were 0.63 (0.44 to 0.90), 0.78 (0.55 to 1.10), and 0.87 (0.62 to 1.22), indicating lower falls incidence with increasing mean S-25(OH)D levels. There were 42% fewer fallers (HR 0.58; 040 to 0.83) in the highest quartile compared to reference. Physical functioning did not differ between quartiles. CONCLUSIONS Falls and faller rates were about 40% lower in the highest S-25(OH)D quartile despite similar physical functioning in all quartiles. Prevalent S-25(OH)D levels may influence individual fall risk. Individual responses to vitamin D treatment should be considered in falls prevention.",2019,"The rates of falls and fallers were about 40% lower in the highest S-25(OH)D quartile compared to the lowest despite no differences in physical functioning, suggesting that S-25(OH)D levels may modulate individual fall risk. ","['70-80\xa0year old women', '387 women were explored in quartiles by mean S-25(OH)D levels over 6-24\xa0months; means (SD) were 59.3 (7.2), 74.5 (3.3), 85.7 (3.5), and 105.3 (10.9', 'older women', 'Three hundred eighty-seven home-dwelling older women']","['vitamin D', 'vitamin D and exercise RCT']","['nmol/L. Falls', 'mean serum 25-hydroxyvitamin D (S-25(OH)D) levels', 'rates of falls and fallers', 'Physical functioning and bone density', 'Serum 25-hydroxyvitamin D levels', 'Physical functioning', 'respective IRRs', 'incidence rate ratios (IRRs) for falls and Cox-regression to assess hazard ratios (HR) for fallers', 'physical functioning and bone density', 'faller rates']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]",387.0,0.0534463,"The rates of falls and fallers were about 40% lower in the highest S-25(OH)D quartile compared to the lowest despite no differences in physical functioning, suggesting that S-25(OH)D levels may modulate individual fall risk. ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Uusi-Rasi', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland. kirsti.uusi-rasi@uta.fi.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Patil', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Karinkanta', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tokola', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kannus', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lamberg-Allardt', 'Affiliation': 'Department of Food and Environmental Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sievänen', 'Affiliation': 'The UKK Institute for Health Promotion Research, P.O. Box 30, 33501, Tampere, Finland.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-018-4705-4'] 661,32124728,"Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.","Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03 B ). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.",2020,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","['One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed', 'Healthy Adults from Puerto Rico']","['placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4-μg /serotype/dose', 'Tetravalent Dengue Purified Inactivated Vaccine', 'Placebo']",['Safety and Immunogenicity'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011315', 'cui_str': 'Breakbone Fever Virus'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0919901,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","[{'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Martinez', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Wilson', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0461'] 662,31444008,SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy.,"PURPOSE This study examined whether short-term use of topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy affected the efficacy of selective laser trabeculoplasty (SLT). DESIGN Double-masked, randomized, placebo-controlled, dual-center, multisurgeon trial. PARTICIPANTS Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy were randomized to 1 of 3 groups in a ratio of 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears. METHODS After SLT, patients randomized into each group were instructed to use an unmarked drop 4 times daily starting the day of SLT and continuing for 4 additional days. The Kruskal-Wallis test and Wilcoxon rank-sum test were used for continuous variables when comparing 2 or 3 treatment groups, respectively. The Fisher exact test was used for categorical variables. MAIN OUTCOME MEASURES The primary outcome of this study was IOP at 12 weeks. Secondary outcome measures included IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation. RESULTS Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites. The NSAID, steroid, and placebo groups were similar in baseline demographics and baseline IOP (mean, 23.3±3.9 mmHg; P = 0.57). There was no statistically significant difference in IOP decrease among groups at week 6. Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1 mmHg, -5.2±2.7 mmHg, and -3±4.3 mmHg, respectively; P = 0.02 [analysis of variance] and P = 0.002 [t test] for NSAID vs. placebo groups; P = 0.02 for steroid vs. placebo groups). CONCLUSIONS Significantly better IOP reduction at 12 weeks was measured in eyes treated with steroid or NSAID drops after SLT. Short-term postoperative use of NSAID or steroid drops may improve IOP reduction after SLT. Longer-term follow-up studies are indicated.",2019,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","['Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy', 'Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites']","['NSAID or steroid', 'ketorolac 0.5%, prednisolone 1%, or saline tears', 'selective laser trabeculoplasty (SLT', 'placebo', 'topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy', 'Laser Trabeculoplasty']","['baseline demographics and baseline IOP', 'IOP', 'IOP reduction', 'IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation', 'IOP decrease', 'Selective Laser Trabeculoplasty Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0395482', 'cui_str': 'LTP - laser trabeculoplasty'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0028841', 'cui_str': 'Ocular Hypotony'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]",85.0,0.443463,"Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1","[{'ForeName': 'Sylvia L', 'Initials': 'SL', 'LastName': 'Groth', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Eiyass', 'Initials': 'E', 'LastName': 'Albeiruti', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Nunez', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Fajardo', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Sharpsten', 'Affiliation': 'Shiley Eye Institute, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Loewen', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Schuman', 'Affiliation': 'Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Goldberg', 'Affiliation': 'Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, California; Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Shiley Eye Institute, University of California, San Diego, La Jolla, California. Electronic address: eye-chair@stanford.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.05.032'] 663,31981587,Can point-of-sale nutrition information and health warnings encourage reduced preference for sugary drinks?: An experimental study.,"Point-of-sale (POS) interventions that prompt consumers to more critically evaluate sugary drinks could encourage reduced consumption of these drinks and reinforce public health campaign messages. This study tested whether: (i) POS nutrition information and health warnings about sugary drinks promote healthier drink choices and (ii) impacts of prominent POS signs on drink choices vary based on participants' self-reported prior exposure to a sugary drink public health campaign. In an online experiment, 3034 Australian adults aged 18-59 years who were past-week sugary drink consumers were randomly assigned to one of five POS signage conditions (no signage (control); sugar content of specific beverages; Health Star Rating of specific beverages; generic text health warning about sugary drinks; generic graphic health warning about sugary drinks) and shown their randomly assigned POS sign alone, then alongside a drinks product display and asked to select which drink they would choose to buy. The proportion selecting a sugary drink was significantly lower among participants who viewed either the sugar content (29%), Health Star Rating (33%) or graphic health warning (34%) signs compared to those who saw no sign (43%). These effects held for participants who did not recall previously seeing the campaign; however, for participants with self-reported prior exposure to the campaign, POS signs did not promote significant reductions in sugary drink choices. POS signage has the potential to shift consumers away from choosing sugary drinks and could complement mass media campaigns by reaching people who may not otherwise be exposed to sugary drink public health messages.",2020,"The proportion selecting a sugary drink was significantly lower among participants who viewed either the sugar content (29%), Health Star Rating (33%) or graphic health warning (34%) signs compared to those who saw no sign (43%).","[""participants' self-reported prior exposure to a sugary drink public health campaign"", '3034 Australian adults aged 18-59 years who were past-week sugary drink consumers']","['sale (POS) interventions', 'five POS signage conditions (no signage (control); sugar content of specific beverages; Health Star Rating of specific beverages; generic text health warning about sugary drinks; generic graphic health warning about sugary drinks) and shown their randomly assigned POS sign alone, then alongside a drinks product display and asked to select which drink they would choose to buy']","['Health Star Rating', 'graphic health warning']","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1720594', 'cui_str': 'Then'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",3034.0,0.0263353,"The proportion selecting a sugary drink was significantly lower among participants who viewed either the sugar content (29%), Health Star Rating (33%) or graphic health warning (34%) signs compared to those who saw no sign (43%).","[{'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Morley', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Australia; School of Psychology, Faculty of Health Sciences, Curtin University, Bentley, Australia. Electronic address: Helen.Dixon@cancervic.org.au.'}]",Appetite,['10.1016/j.appet.2020.104612'] 664,32167550,Randomized Controlled Trial Comparing Landmark and Ultrasound-Guided Glossopharyngeal Nerve in Eagle Syndrome.,"INTRODUCTION The glossopharyngeal nerve lies posterior to the internal carotid artery at the submandibular region. The primary objective of this study was to compare ultrasound-guided glossopharyngeal nerve block (UGPNB) and landmark glossopharyngeal nerve block (GPNB). MATERIALS & METHODS Inclusion criteria were patients with unilateral Eagle syndrome and ear pain. Group UGPNB (N = 25) received three UGPNBs at weekly intervals with 1.5 mL of 0.5% ropivacaine and 20 mg of methylprednisolone. Group GPNB (N = 26) received landmark GPNB. Pain intensity was evaluated with the numerical rating scale (NRS) before every block, 30 minutes after every block, and at one, three, and five weeks after the third block. Quality of life, assessed using the Brief Pain Inventory (BPI), and satisfaction scores were noted. RESULTS NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5. NRS scores 30 minutes after every block were significantly decreased from the preblock values but were comparable between groups. In 68% of patients, a curvilinear probe delineated the internal carotid artery (ICA). Out-of-plane needle trajectory was required in 64% of patients. BPI and satisfaction scores were significantly better in the UGPNB group in the ""block"" weeks. CONCLUSIONS UGPNB with 1.5 mL of 0.5% ropivacaine and 20 mg of methylprednisolone injected posterior to the ICA in the submandibular region provides better pain relief for at least a week compared with an extraoral landmark technique when three weekly consecutive blocks are given. In most patients, a curvilinear probe and out-of-plane needle trajectory are most suitable for ultrasound block.",2020,"RESULTS NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5.","['Inclusion criteria were patients with unilateral Eagle syndrome and ear pain', 'Eagle Syndrome']","['Landmark and Ultrasound-Guided Glossopharyngeal', 'ultrasound-guided glossopharyngeal nerve block (UGPNB) and landmark glossopharyngeal nerve block (GPNB', 'UGPNB', 'landmark GPNB', 'methylprednisolone', 'ropivacaine and 20\u2009mg of methylprednisolone', 'ropivacaine']","['BPI and satisfaction scores', 'internal carotid artery (ICA', 'Quality of life, assessed using the Brief Pain Inventory (BPI), and satisfaction scores', 'pain relief', 'Pain intensity', 'NRS scores', 'numerical rating scale (NRS']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1868714', 'cui_str': 'Elongated styloid process syndrome'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394814', 'cui_str': 'Local anesthetic glossopharyngeal nerve block (procedure)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}]",,0.0637826,"RESULTS NRS scores before the second and third blocks and a week after were significantly lower in group UGPNB and comparable at weeks 3 and 5.","[{'ForeName': 'Shanmuga', 'Initials': 'S', 'LastName': 'Sundaram', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Punj', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz370'] 665,32167975,ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery.,"BACKGROUND Recent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear. METHODS This exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery. RESULTS All outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5). CONCLUSIONS The use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.",2020,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","['patients who were ≥65 years of age undergoing elective noncardiac surgery', 'cognitively vulnerable patients', 'Two hundred and four patients with a mean age of 72 ± 5 years were studied', 'Older Surgical Patients Undergoing Major Noncardiac Surgery']","['Intraoperative EEG Suppression', 'processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA', 'ADAPT-2']","['EEG suppression', 'incidence rate ratio', 'EEG suppression and subsequent postoperative delirium', 'incident postoperative delirium', 'intraoperative EEG suppression', 'Minutes of EEG suppression adjusted by the length of surgery', 'incidence of delirium', 'Preoperative cognitive impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0430854', 'cui_str': 'Electroencephalogram for monitoring at surgery (regime/therapy)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0430854', 'cui_str': 'Electroencephalogram for monitoring at surgery (regime/therapy)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",204.0,0.158331,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tang', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Sands', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Pleasants', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabatabai', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Leung', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004713'] 666,32167837,Blood Flow Restriction Training Applied With High-Intensity Exercise Does Not Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.,"BACKGROUND A major goal of rehabilitation after anterior cruciate ligament reconstruction (ACLR) is restoring quadriceps muscle strength. Unfortunately, current rehabilitation paradigms fall short of this goal, such that substantial quadriceps muscle strength deficits can limit return to play and increase the risk of recurrent injuries. Blood flow restriction training (BFRT) involves the obstruction of venous return to working muscles during exercise and may lead to better recovery of quadriceps muscle strength after ACLR. PURPOSE To examine the efficacy of BFRT with high-intensity exercise on the recovery of quadriceps muscle function in patients undergoing ACLR. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS A total of 34 patients (19 female, 15 male; mean age, 16.5 ± 2.7 years; mean height, 169.0 ± 19.7 cm; mean weight, 73.2 ± 17.7 kg) scheduled to undergo ACLR were randomly assigned to 1 of 4 groups: concentric (n = 8), eccentric (n = 8), concentric with BFRT (n = 9), and eccentric with BFRT (n = 9). The exercise component of the intervention consisted of patients performing a single-leg isokinetic leg press, at an intensity of 70% of the patients' 1-repetition maximum during either the concentric or eccentric action, for 4 sets of 10 repetitions 2 times per week for 8 weeks beginning at 10 weeks postoperatively. Patients randomized to the BFRT groups performed the leg-press exercise with a cuff applied to the thigh, set to a limb occlusion pressure of 80%. Isometric and isokinetic (60 deg/s) quadriceps peak torque, quadriceps muscle activation, and rectus femoris muscle volume were assessed before ACLR, after BFRT, and at the time that patients returned to activity and were converted to the change in values from baseline for analysis. Also, 1-way analyses of covariance were used to compare the change in values for each dependent variable between groups after BFRT and at return to activity ( P ≤ .05). RESULTS No significant differences were found between groups for any outcome measures at either time point ( P > .05). CONCLUSION An 8-week BFRT plus high-intensity exercise intervention did not significantly improve quadriceps muscle strength, activation, or volume. On the basis of our findings, the use of BFRT in conjunction with high-intensity resistance exercise in patients undergoing ACLR to improve quadriceps muscle function may not be warranted. REGISTRATION NCT03141801 ( ClinicalTrials.gov identifier).",2020,"An 8-week BFRT plus high-intensity exercise intervention did not significantly improve quadriceps muscle strength, activation, or volume.","['patients undergoing ACLR', 'After Anterior Cruciate Ligament Reconstruction', '34 patients (19 female, 15 male; mean age, 16.5 ± 2.7 years; mean height, 169.0 ± 19.7 cm; mean weight, 73.2 ± 17.7 kg) scheduled to undergo ACLR']","['leg-press exercise', 'BFRT with high-intensity exercise', 'anterior cruciate ligament reconstruction (ACLR', 'patients performing a single-leg isokinetic leg press', 'BFRT plus high-intensity exercise intervention', 'Blood Flow Restriction Training Applied With High-Intensity Exercise', 'Blood flow restriction training (BFRT', 'BFRT']","['quadriceps muscle function', 'Quadriceps Muscle Function', 'Isometric and isokinetic (60 deg/s) quadriceps peak torque, quadriceps muscle activation, and rectus femoris muscle volume', 'quadriceps muscle strength, activation, or volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0584894', 'cui_str': 'Rectus Femoris'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",34.0,0.0526367,"An 8-week BFRT plus high-intensity exercise intervention did not significantly improve quadriceps muscle strength, activation, or volume.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Curran', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Wojtys', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Kujawa', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Riann M', 'Initials': 'RM', 'LastName': 'Palmieri-Smith', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520904008'] 667,32163578,Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial.,"BACKGROUND Low serum bicarbonate level is associated with increased mortality, but its role as a predictor of cardiovascular disease (CVD) is unclear. This study evaluates the association between serum bicarbonate concentration and CVD and whether the effect of intensive blood pressure (BP) lowering on CVD outcomes is modified by serum bicarbonate level. METHODS The Systolic Blood Pressure Intervention Trial (SPRINT) randomized participants to a systolic BP target <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). The primary CVD outcome was a composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death. Cox proportional hazards models adjusted for demographic, clinical and laboratory characteristics were used to evaluate the association of interest in 9334 SPRINT participants (ClinicalTrials.gov: NCT01206062). RESULTS Over a median follow-up of 3.33 years (interquartile range 2.87-3.87 years), 618 (6.6%) participants experienced a primary CVD outcome. Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L. The magnitude of the CVD risk reduction with intensive BP lowering was similar across bicarbonate strata (P-value for interaction = 0.97). CONCLUSIONS In hypertensive individuals, serum bicarbonate level <22 mEq/L was associated with an increased CVD risk. The effect of intensive BP lowering on CVD outcomes was not modified by the serum bicarbonate level.",2019,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","['participants to a systolic BP target <120\u2009mmHg (intensive treatment) or <140\u2009mmHg (standard treatment', 'hypertensive adults']","['intensive blood pressure (BP', 'intensive BP lowering']","['CVD outcomes', 'Serum bicarbonate and cardiovascular events', 'composite of nonfatal myocardial infarction (MI), acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure and CVD death', 'CVD risk', 'risk of the primary CVD outcome', 'serum bicarbonate level']","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",9334.0,0.215464,"Participants with serum bicarbonate <22 mEq/L had a significantly higher risk of the primary CVD outcome (hazard ratio 1.54; 95% confidence interval 1.11-2.14, P = 0.01), compared with participants with bicarbonate 22-26 mEq/L.","[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Dobre', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Renal Diseases and Hypertension, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'VA Medical Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Servilla', 'Affiliation': 'Nephrology, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Medicine, Nephrology, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Veterans Affairs Salt Lake City Healthcare System, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz149'] 668,31267366,"A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD.","INTRODUCTION Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), formulated using co-suspension delivery technology, is the only approved fixed-dose combination long-acting muscarinic antagonist/long-acting β 2 -agonist (LAMA/LABA) delivered via MDI. Direct comparisons of GFF MDI versus other LAMA/LABAs have not previously been performed. We assessed the efficacy and safety of GFF MDI relative to umeclidinium/vilanterol dry powder inhaler (UV DPI) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). METHODS In this phase IIIb randomized, double-blind, double-dummy, multicenter, 24-week study, patients received GFF MDI 18/9.6 μg (equivalent to glycopyrronium/formoterol fumarate dihydrate 14.4/10 μg; two inhalations per dose, twice-daily; n = 559) or UV DPI 62.5/25 μg (one inhalation, once-daily; n = 560). Primary endpoints were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) and peak change from baseline in FEV 1 within 2 h post-dose, both over 24 weeks. Additional lung function, symptom and safety endpoints were also assessed. RESULTS For the primary endpoints, GFF MDI was non-inferior to UV DPI (using a margin of - 50 mL) for peak FEV 1 (least squares mean [LSM] difference - 3.4 mL, 97.5% confidence interval [CI] - 32.8, 25.9) but not for trough FEV 1 (LSM difference - 87.2 mL; - 117.0, - 57.4). GFF MDI was nominally superior to UV DPI for onset of action (p < 0.0001) and was nominally non-inferior to UV DPI for all symptom endpoints (Transition Dyspnea Index focal score, Early Morning/Night-Time Symptoms COPD instrument scores, and COPD Assessment Test score). Exacerbation and safety findings were similar between groups. CONCLUSIONS Over 24 weeks of treatment, GFF MDI was non-inferior to UV DPI for peak FEV 1 , but not for morning pre-dose trough FEV 1 . GFF MDI had a faster onset of action versus UV DPI. There were no clinically meaningful differences between treatments in symptom endpoints. Both treatments were well tolerated with similar safety profiles. TRIAL REGISTRATION NCT03162055 (Clinicaltrials.gov) FUNDING: AstraZeneca.",2019,"GFF MDI was nominally superior to UV DPI for onset of action (p < 0.0001) and was nominally non-inferior to UV DPI for all symptom endpoints (Transition Dyspnea Index focal score,","['patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD', 'COPD']","['LAMA/LABAs', 'umeclidinium/vilanterol dry powder inhaler (UV DPI', 'GFF MDI', 'Glycopyrrolate/Formoterol Fumarate', 'GFF MDI 18/9.6\xa0μg (equivalent to glycopyrronium/formoterol fumarate dihydrate', 'Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI']","['Early Morning/Night-Time Symptoms COPD instrument scores, and COPD Assessment Test score', 'GFF MDI', 'Exacerbation and safety findings', 'change from baseline in morning pre-dose trough forced expiratory volume in 1\xa0s (FEV 1 ) and peak change from baseline in FEV 1', 'Additional lung function, symptom and safety endpoints']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C3709482', 'cui_str': 'umeclidinium / vilanterol Dry Powder Inhaler [Anoro]'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C1579393', 'cui_str': 'formoterol fumarate dihydrate'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0581560', 'cui_str': 'Safety finding'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.738632,"GFF MDI was nominally superior to UV DPI for onset of action (p < 0.0001) and was nominally non-inferior to UV DPI for all symptom endpoints (Transition Dyspnea Index focal score,","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, QC, Canada. Francois.Maltais@med.ulaval.ca.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Feldman', 'Affiliation': 'S. Carolina Pharmaceutical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Deslee', 'Affiliation': 'Hôpital Maison Blanche, INSERM U1250, Service des Maladies Respiratoires, CHU de Reims, Reims, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'CHU Montpellier, PhyMedExp, INSERM, CNRS, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Fjällbrant', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Siwek-Posłuszna', 'Affiliation': 'AstraZeneca, Warsaw, Poland.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Jenkins', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Advances in therapy,['10.1007/s12325-019-01015-3'] 669,31267367,"Pharmacokinetics, Safety and Tolerability of JNJ-56136379, a Novel Hepatitis B Virus Capsid Assembly Modulator, in Healthy Subjects.","INTRODUCTION Hepatitis B viral capsid assembly is an attractive target for new antiviral treatments. JNJ-56136379 (JNJ-6379) is a potent capsid assembly modulator in vitro with a dual mode of action. In Part 1 of this first-in-human study in healthy adults, the pharmacokinetics (PK), safety and tolerability of JNJ-6379 were evaluated following single ascending and multiple oral doses. METHODS This was a double-blind, randomized, placebo-controlled study in 30 healthy adults. Eighteen subjects were randomized to receive single doses of JNJ-6379 (25 to 600 mg) or placebo. Twelve subjects were randomized to receive 150 mg JNJ-6379 or placebo twice daily for 2 days, followed by 100 mg JNJ-6379 or placebo daily for 10 days. RESULTS The maximum observed plasma concentration and the area under the curve increased dose proportionally from 25 to 300 mg JNJ-6379. Following multiple dosing, steady-state conditions were achieved on day 8. Steady-state clearance was similar following single and multiple dosing, suggesting time-linear PK. All adverse events (AEs) reported were mild to moderate in severity. There were no serious AEs or dose-limiting toxicities and no apparent relationship to dose for any AE. CONCLUSION JNJ-6379 was well tolerated in this study. Based on the safety profile and plasma exposures of JNJ-6379 in healthy subjects, a dosing regimen was selected for Part 2 of this study in patients with chronic hepatitis B. This is anticipated to achieve trough plasma exposures of JNJ-6379 at steady state of more than three times the 90% effective concentration of viral replication determined in vitro. TRIAL REGISTRATION Clinicaltrials.gov identifier, NCT02662712. FUNDING Janssen Pharmaceutica.",2019,"There were no serious AEs or dose-limiting toxicities and no apparent relationship to dose for any AE. ","['healthy subjects', 'Healthy Subjects', 'Eighteen subjects', 'patients with chronic hepatitis B', 'Twelve subjects', '30 healthy adults', 'healthy adults']","['JNJ-6379 or placebo', 'JNJ-6379', 'placebo']","['Pharmacokinetics, Safety and Tolerability', 'Steady-state clearance', 'plasma concentration', 'serious AEs or dose-limiting toxicities', 'pharmacokinetics (PK), safety and tolerability of JNJ-6379']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",30.0,0.109237,"There were no serious AEs or dose-limiting toxicities and no apparent relationship to dose for any AE. ","[{'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Vandenbossche', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium. jvdbossc@its.jnj.com.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Jessner', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van den Boer', 'Affiliation': 'Janssen Pharmaceutica NV, Merksem, Belgium.'}, {'ForeName': 'Jeike', 'Initials': 'J', 'LastName': 'Biewenga', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Jan Martin', 'Initials': 'JM', 'LastName': 'Berke', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Talloen', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Loeckie', 'Initials': 'L', 'LastName': 'De Zwart', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Snoeys', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Jeysen', 'Initials': 'J', 'LastName': 'Yogaratnam', 'Affiliation': 'Janssen Biopharma, Inc., South San Francisco, CA, USA.'}]",Advances in therapy,['10.1007/s12325-019-01017-1'] 670,31358387,"No CFH or ARMS2 Interaction with Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin on Progression of Age-Related Macular Degeneration in the Age-Related Eye Disease Study 2: Age-Related Eye Disease Study 2 Report No. 18.","PURPOSE To assess whether genotypes at 2 major loci associated with age-related macular degeneration (AMD), complement factor H (CFH), or age-related maculopathy susceptibility 2 (ARMS2), modify the response to oral nutrients for the treatment of AMD in the Age-Related Eye Disease Study 2 (AREDS2). DESIGN Post hoc analysis of a randomized trial. PARTICIPANTS White AREDS2 participants. METHODS AREDS2 participants (n = 4203) with bilateral large drusen or late AMD in 1 eye were assigned randomly to lutein and zeaxanthin, omega-3 fatty acids, both, or placebo, and most also received the AREDS supplements. A secondary randomization assessed modified AREDS supplements in 4 treatment arms: lower zinc dosage, omission of β-carotene, both, or no modification. To evaluate the progression to late AMD, fundus photographs were obtained at baseline and annual study visits, and history of treatment for late AMD was obtained at study visits and 6-month interim telephone calls. Participants were genotyped for the single-nucleotide polymorphisms rs1061170 in CFH and rs10490924 in ARMS2. Bivariate frailty models using both eyes were conducted, including a gene-supplement interaction term and adjusting for age, gender, level of education, and smoking status. The main treatment effects, as well as the direct comparison between lutein plus zeaxanthin and β-carotene, were assessed for genotype interaction. MAIN OUTCOME MEASURES The interaction between genotype and the response to AREDS2 supplements regarding progression to late AMD, any geographic atrophy (GA), and neovascular AMD. RESULTS Complete data were available for 2775 eyes without baseline late AMD (1684 participants). The participants (mean age ± standard deviation, 72.1±7.7 years; 58.5% female) were followed up for a median of 5 years. The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5 and P = 0.002, respectively), but not any GA (P = 0.097). The CFH risk allele was not associated with AMD progression. Genotype did not modify significantly the response to any of the AREDS2 supplements. CONCLUSIONS CFH and ARMS2 risk alleles do not modify the response to the AREDS2 nutrient supplements with respect to the progression to late AMD (GA and neovascular AMD).",2019,"The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5 and P = 0.002, respectively), but not any GA (P = 0.097).","['participants (mean age ± standard deviation, 72.1±7.7 years; 58.5% female', '2775 eyes without baseline late AMD (1684 participants', 'participants (n\xa0= 4203) with bilateral large drusen or late AMD in 1 eye', 'Age-Related Macular Degeneration in the Age-Related Eye Disease\xa0Study 2: Age-Related Eye Disease Study 2', 'White AREDS2 participants']","['AREDS2', 'Omega-3 Fatty Acids, Low versus High Zinc, or β-Carotene versus Lutein and Zeaxanthin', 'lutein and zeaxanthin, omega-3 fatty acids, both, or placebo']","['progression to late AMD and neovascular AMD', 'lower zinc dosage, omission of β-carotene, both, or no modification']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1260959', 'cui_str': 'Drusen'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]",1684.0,0.0431204,"The ARMS2 risk allele was associated significantly with progression to late AMD and neovascular AMD (P = 2.40 × 10 -5 and P = 0.002, respectively), but not any GA (P = 0.097).","[{'ForeName': 'Freekje', 'Initials': 'F', 'LastName': 'van Asten', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Preventive Medicine and Genetics, Genomics & Informatics, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Biostatistics, The EMMES Company, Rockville, Maryland.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Ratnapriya', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Swaroop', 'Affiliation': 'Neurobiology-Neurodegeneration and Repair Laboratory, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Ruzong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: echew@nei.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.06.004'] 671,32043808,"The effectiveness, safety and compliance of Zheng's supine rehabilitation exercise as a rehabilitation programme among elderly patients with AECOPD.","PURPOSE We investigated the effectiveness, safety and compliance of Zheng's Supine Rehabilitation Exercise (ZSRE) as a rehabilitation programme among elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). PATIENTS AND METHODS About 82 elderly patients with AECOPD were divided into a rehabilitation group and control group on their admission day, and both groups received routine medical treatment. Patients in the rehabilitation group started ZSRE on the second day of admission and continued until 8 weeks after discharge. RESULTS At the 9th week after discharge, the COPD Assessment Test (CAT), 6-minute walking distance (6MWD) and Modified Medical Research Council Dyspnea Scale (mMRC) in the rehabilitation group were all significantly better than those in the control group (P < 0.01; P < 0.01; and P < 0.05, respectively). In the rehabilitation group, the CAT and 6MWD were significantly improved in the 9th week after discharge as compared with those at admission or discharge, and mMRC was significantly improved at the 9th week after discharge as compared with that at admission (all P < 0.01). CONCLUSION ZSRE can be performed by elderly patients with the acute exacerbation of severe or extremely severe COPD with high safety and compliance and was helpful for their recovery.",2020,"In the rehabilitation group, the CAT and 6MWD were significantly improved in the 9th week after discharge as compared with those at admission or discharge, and mMRC was significantly improved in the 9th week after discharge as compared with that at admission (all P<0.01). ","['elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD', '82 elderly patients with AECOPD', 'Elderly Patients with AECOPD', 'elderly patients with acute exacerbation of severe or extremely severe COPD']","[""Zheng's Supine Rehabilitation Exercise"", ""Zheng's Supine Rehabilitation Exercise (ZSRE"", 'ZSRE', 'routine medicine treatment']","['CAT and 6MWD', 'effectiveness, safety and compliance', 'CAT, 6MWD, and mMRC', 'Effectiveness, Safety and Compliance']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",82.0,0.0210997,"In the rehabilitation group, the CAT and 6MWD were significantly improved in the 9th week after discharge as compared with those at admission or discharge, and mMRC was significantly improved in the 9th week after discharge as compared with that at admission (all P<0.01). ","[{'ForeName': 'Haonan', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jie Ying', 'Initials': 'JY', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xinni', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Youxia', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Mali', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Li Hong', 'Initials': 'LH', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'RongChang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Shenzhen Institute of Respiratory Diseases, Shenzhen City, China.'}, {'ForeName': 'Zeguang', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",The clinical respiratory journal,['10.1111/crj.13164'] 672,32151570,A community-based effort to increase the rate of follow-up eye examinations of school-age children who fail vision screening: a randomized clinical trial.,"PURPOSE To determine whether enhanced follow-up after failed vision screening, involving more communication with parents/guardians than occurs in a standard protocol, would result in a higher rate of post-screening examination by an eye care provider. METHODS In a study conducted from January through December 2017, 162 children in first- and third-grade who failed a vision screening in their Wayne County, Michigan, schools were randomly assigned to receive an enhanced or the standard follow-up protocol. RESULTS The average age of the children was 7.9 ± 1.1years; 84 (52%) were males. In the enhanced follow-up group, 52 of 80 (65%) had a documented eye examination within 16 weeks of their screening; the rate in those receiving standard follow-up was 48% (39/82). The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%). The enhanced follow-up group's odds of obtaining a documented eye examination was twice that of the standard follow-up group (OR = 2.05; 95% CI, 1.09-3.85; P = 0.026). CONCLUSIONS In this study cohort, methods to enhance communication proved effective in increasing the likelihood that children who failed vision screenings would receive an examination by an eye care provider.",2020,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","['school-age children who fail vision screening', 'January through December 2017, 162 children in first- and third-graders who failed a vision screening in their Wayne County, Michigan, schools', 'The average age of the children was 7.9 ± 1.1years; 84 (52%) were males']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042792', 'cui_str': 'Vision Screening'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.120289,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan. Electronic address: dmusch@med.umich.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schumann', 'Affiliation': 'Department of Health and Human Services, State of Michigan, Lansing, Michigan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': ""Children's Hospital of Michigan, Detroit, Michigan.""}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2019.12.012'] 673,32142529,Continuous wound infiltration versus epidural analgesia for midline abdominal incisions - a randomized-controlled pilot trial (Painless-Pilot trial; DRKS Number: DRKS00008023).,"OBJECTIVES To test the feasibility of a randomized controlled study design comparing epidural analgesia (EDA) with continuous wound infiltration (CWI) in respect to postoperative complications and mobility to design a future multicentre randomized controlled trial. DESIGN, SETTING, PARTICIPANTS CWI has been developed to address drawbacks of EDA. Previous studies have established the equivalent analgesic potential of CWI compared to EDA. This is a single centre, non-blinded pilot randomized controlled trial at a tertiary surgical centre. Patients undergoing elective non-colorectal surgery via a midline laparotomy were randomized to EDA or CWI. Endpoints included recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity. No primary endpoint was defined and all analyses were explorative. INTERVENTIONS CWI with local anaesthetics (experimental group) vs. thoracic EDA (control). RESULTS Of 846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis. Mobility was assessed in 44 of 62 patients and revealed no differences within the first 3 postoperative days. Overall morbidity did not differ between the two groups (measured via the comprehensive complication index). Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day. Duration of preoperative induction of anaesthesia was shorter with CWI than with EDA. Of 17 serious adverse events, 3 were potentially related to EDA, while none was related to CWI. CONCLUSION This trial confirmed the feasibility of a randomized trial design to compare CWI and EDA regarding morbidity. Improvements in the education and training of team members are necessary to improve recruitment. TRIAL REGISTRATION DRKS00008023.",2020,"Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day.","['Patients undergoing elective non-colorectal surgery via a midline laparotomy', '846 patients screened within 14 months, 71 were randomized and 62 (31 per group) included in the intention-to-treat analysis']","['Continuous wound infiltration versus epidural analgesia', 'CWI with local anaesthetics (experimental group) vs. thoracic EDA (control', 'EDA or CWI', 'epidural analgesia (EDA) with continuous wound infiltration (CWI']","['Median pain scores', 'Overall morbidity', 'recruitment, feasibility of assessing postoperative mobility with a pedometer and morbidity', 'Mobility', 'Duration of preoperative induction of anaesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}]",71.0,0.157879,"Median pain scores at rest were comparable between the two groups, while EDA was superior in pain treatment during movement on the first, but not on the second and third postoperative day.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Klotz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Svenja E', 'Initials': 'SE', 'LastName': 'Seide', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Motsch', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hyhlik-Dürr', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dittmar', 'Initials': 'D', 'LastName': 'Böckler', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0229898'] 674,32155628,Impact of Anterior Kidney Calyx Involvement of Complex Stones on Outcomes for Patients Undergoing Percutaneous Nephrolithotomy.,"INTRODUCTION A number of factors that can impact the outcomes of percutaneous nephrolithotomy (PCNL) procedures have previously been investigated. Complex stones that extend to the anterior calyx could affect the success and complication rates of PCNL. OBJECTIVE We analyzed the effect of anterior calyx involvement on the outcomes of patients with complex stones treated with PCNL. METHODS A total of 132 consecutive patients who underwent PCNL due to complex stones (multiple, partial staghorn, or staghorn stones) between 2015 and 2017 were enrolled in this study. They were stratified into two groups based on whether the stone extended to the anterior calyx (group 1, n = 45) or not (group 2, n = 87). The stratification was achieved through contrast-enhanced computerized tomography (CT). Demographics, laboratory tests, and peri- and postoperative findings (operation and fluoroscopy duration, hospital stay, utilization of flexible instruments, access numbers, total blood count change, stone-free rate [SFR], and complications) were compared between the groups. The SFR was evaluated by plain kidney-ureter-bladder radiography or CT. RESULTS The demographics, operation and fluoroscopy duration, access number, and hospital stay were similar between the groups (p < 0.05). A higher drop in the hemoglobin level in group 1 was identified (group 1 [2.14 ± 1.49 g/dL] vs. group 2 [1.43 ± 1.31 g/dL]) (p = 0.006). The SFR among the patients with extension to the anterior calyx was 60%, compared to 77% among the patients with no extension to the anterior calyx (p = 0.041). Flexible instruments were utilized in 60% of the patients of group 1, which was a higher rate than for group 2 (36%) (p = 0.007). Complication rates were similar in the two groups according to the Clavien-Dindo classification (p > 0.05). CONCLUSIONS Our study demonstrated that complicated stones with extension to the anterior calyx are more challenging than cases without extension to the anterior calyx. This was noted by a lower SFR, a more prominent drop in total blood count, and more frequent utilization of flexible scopes.",2020,"Flexible instruments were utilized in 60% of the patients of group 1, which was a higher rate than for group 2 (36%) (p = 0.007).","['Patients Undergoing Percutaneous Nephrolithotomy', '132 consecutive patients who underwent PCNL due to complex stones (multiple, partial staghorn, or staghorn stones) between 2015 and 2017 were enrolled in this study', 'patients with complex stones treated with PCNL']","['Complex Stones', 'percutaneous nephrolithotomy (PCNL']","['total blood count', 'Demographics, laboratory tests, and peri- and postoperative findings (operation and fluoroscopy duration, hospital stay, utilization of flexible instruments, access numbers, total blood count change, stone-free rate [SFR], and complications', 'frequent utilization of flexible scopes', 'Complication rates', 'demographics, operation and fluoroscopy duration, access number, and hospital stay', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0332249', 'cui_str': 'Staghorn (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",132.0,0.0358364,"Flexible instruments were utilized in 60% of the patients of group 1, which was a higher rate than for group 2 (36%) (p = 0.007).","[{'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kalkanli', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey, arifkalkanli@gmail.com.'}, {'ForeName': 'Nusret Can', 'Initials': 'NC', 'LastName': 'Cilesiz', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Fikri', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Ozkan', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Cem Tugrul', 'Initials': 'CT', 'LastName': 'Gezmis', 'Affiliation': 'Department of Urology, Bitlis State Hospital, Bitlis, Turkey.'}, {'ForeName': 'Memduh', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Tandoğdu', 'Affiliation': 'Department of Urology, Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",Urologia internationalis,['10.1159/000505822'] 675,32119700,Depth of acid penetration and enamel surface roughness associated with different methods of interproximal enamel reduction.,"OBJECTIVES To assess and compare the enamel surface quality after interproximal enamel reduction (IPR) was performed with different systems and to study the relation between acid penetration depth and enamel surface quality as well as the importance of remineralization. METHODS Sixty-five extracted teeth were randomly allocated to five experimental groups: untreated control, manual with New Metal Strips, mechanical with oscillating segment (OS) discs, Safe-Tipped Bur Kit, and the Ortho-Strip, followed by 30 s of polishing with the Softflex system and the Compo-system after treating the tooth with OS discs. Mesial surfaces were demineralized for 24 h and distal surfaces were subjected to interchanging demineralization and remineralization cycles of 24 h each for 18 days. The analysis was carried out by profilometry, scanning electron microscopy, and polarization microscopy. RESULTS After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit. Subsequent demineralization increased enamel roughness in all groups except controls beyond the original level prior to IPR except for IPR with New Metal Strips or Ortho-Strips and subsequent polishing. Cyclic demineralization and remineralization for 18 days yielded a reduction in acid penetration depth and an increase in surface smoothness, which correlated with each other only for controls and treatment with New Metal Strips or Ortho-Strips. CONCLUSIONS Manual IPR, using New Metal Strips and, even more, the oscillating IPR system Ortho-Strips, yielded smoother interproximal enamel surfaces and less acid penetration depth than the IPR systems with OS discs and the Safe-Tipped Bur Kit after polishing and 18 days of cyclic demineralization and remineralization. Irrespective of the IPR procedure, proper remineralization of IPR-treated surfaces is advisable to reduce caries susceptibility.",2020,"After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit.",['Sixty-five extracted teeth'],"['untreated control, manual with New Metal Strips, mechanical with oscillating segment (OS) discs, Safe-Tipped Bur Kit, and the Ortho-Strip, followed by 30 s of polishing with the Softflex system and the Compo-system', 'interproximal enamel reduction (IPR']","['enamel roughness', 'acid penetration depth', 'surface smoothness', 'enamel surface quality']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0700351', 'cui_str': 'Bur (physical object)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",65.0,0.0219832,"After IPR and polishing, enamel roughness was reduced for all systems tested except for the Essix Safe-Tipped Bur Kit.","[{'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Danesh', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Pascal Kai Konstantin', 'Initials': 'PKK', 'LastName': 'Podstawa', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Cate-Emilia', 'Initials': 'CE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Orthodontics, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kirschneck', 'Affiliation': 'Department of Orthodontics, University Medical Centre of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Bizhang', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Arnold', 'Affiliation': 'Department of Biological and Material Sciences in Dentistry, Faculty of Health, School of Dentistry, Witten/Herdecke University, Witten, Germany.'}]",PloS one,['10.1371/journal.pone.0229595'] 676,31838258,Program to improve mobility in aging (PRIMA) study: Methods and rationale of a task-oriented motor learning exercise program.,"Walking difficulty is a common and costly problem in older adults. A potentially important yet unaddressed strategy to enhance walking ability through exercise intervention is to add a timing and coordination component in gait training (i.e. task specific timing and coordination exercise intervention) to the usual strength, endurance, and flexibility training. We describe the methods and rationale of a randomized single-blind, physical therapist supervised, exercise intervention trial to compare the effects of a standard strength, endurance, and flexibility program to a standard plus timing and coordination program in community-dwelling older adults walking slower than the desired gait speed of 1.2 m/s. Exercise sessions are twice weekly for 12 weeks. Participants are assessed at baseline, 12 weeks (post intervention), 24 weeks and 36 weeks. The primary outcome is gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity). The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time. The information derived from this project will provide valuable insight into the prevention and management of walking difficulty, which is so common in older Americans.",2020,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","['older Americans', 'older adults', 'community-dwelling older adults walking slower than the desired gait speed of 1.2\u202fm/s']","['standard strength, endurance, and flexibility program to a standard plus timing and coordination program', 'task-oriented motor learning exercise program']","['gait speed, secondary outcomes represent components of the interventions (strength, endurance, flexibility, timing and coordination), and tertiary outcomes are measure of activity and participation (Late Life Function and Disability Instrument and physical activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.040983,"The findings of this trial will (1) establish if a standard-plus task specific timing and coordination program is superior to a standard strength and endurance program in improving mobility, activity and participation and (2) determine if the improvements are sustained over time.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: jbrach@pitt.edu.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gil', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Neurology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Rakie', 'Initials': 'R', 'LastName': 'Cham', 'Affiliation': 'Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105912'] 677,32100681,"Effect of Improved Water Quality, Sanitation, Hygiene and Nutrition Interventions on Respiratory Illness in Young Children in Rural Bangladesh: A Multi-Arm Cluster-Randomized Controlled Trial.","Acute respiratory infections cause mortality in young children. We assessed the effects of water, sanitation, hygiene (WASH) and nutritional interventions on childhood ARI. Geographic clusters of pregnant women from rural Bangladesh were randomly assigned to receive 1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control). Masking of participants was not possible. Acute respiratory illness was defined as caregiver-reported persistent cough, panting, wheezing, or difficulty breathing in the past 7 days among index children, those born to enrolled women. We assessed outcomes at 12 and 24 months of intervention using intention to treat. Compared with children in the control group (ARI prevalence, P : 8.9%), caregivers of index children reported significantly lower ARI in the water ( P : 6.3%, prevalence ratio (PR): 0.71; 95% CI: 0.53, 0.96), sanitation ( P : 6.4%, PR: 0.75, 95% CI: 0.58, 0.96), handwashing ( P : 6.4%, PR: 0.68, 95% CI: 0.50, 0.93), and the combined WSH+N arms ( P : 5.9%, PR: 0.67, 95% CI: 0.50, 0.90). Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children. Single targeted water, sanitation, and hygiene interventions reduced reported respiratory illness in young children. There was no apparent respiratory health benefit from combining WASH interventions.",2020,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","['young children', 'Geographic clusters of pregnant women from rural Bangladesh', 'childhood ARI', 'Young Children in Rural Bangladesh']","['water, sanitation, hygiene (WASH) and nutritional interventions', 'Water Quality, Sanitation, Hygiene and Nutrition Interventions', '1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control']","['ARI prevalence', 'Respiratory Illness', 'respiratory illness', 'Acute respiratory infection', 'ARI']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}]",,0.134988,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","[{'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Benjamin-Chung', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'School of Public Health and Health Professions, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0769'] 678,31230016,Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.,"INTRODUCTION Pre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children. METHODS AND ANALYSIS The RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8-18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24 hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle. ETHICAL APPROVAL AND DISSEMINATION The study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03636165; Pre-results.",2019,"The RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8-18 years undergoing intracranial surgery.","['children (RP/MP vs RP', 'after craniotomy in children', '100 children aged 8-18 years undergoing intracranial surgery', 'Beijing Tiantan Hospital Affiliated to Capital Medical University']","['Methylprednisolone (MP', 'pre-emptive scalp infiltration with either RP plus MP or RP alone', 'ropivacaine plus methylprednisolone', 'ropivacaine', 'ropivacaine (RP) plus MP']","['postoperative pain', 'postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events', 'postoperative incisional pain', 'cumulative fentanyl dose administered by patient-controlled intravenous analgesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",100.0,0.27778,"The RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8-18 years undergoing intracranial surgery.","[{'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zipu', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2018-027864'] 679,31248932,A novel group parenting intervention to reduce emotional and behavioural difficulties in young autistic children: protocol for the Autism Spectrum Treatment and Resilience pilot randomised controlled trial.,"INTRODUCTION The majority of young autistic children display impairing emotional and behavioural difficulties that contribute to family stress. There is some evidence that behavioural parenting interventions are effective for reducing behavioural difficulties in autistic children, with less evidence assessing change in emotional difficulties. Previous trials have tended to use unblinded parent-report measures as primary outcomes and many do not employ an active control, limiting the conclusions that can be drawn. METHODS AND ANALYSIS The Autism Spectrum Treatment and Resilience study is a pilot randomised controlled trial (RCT) testing the specific effect of a 12-week group parenting intervention (Predictive Parenting) on primary and secondary outcomes, in comparison to an attention control condition consisting of psychoeducation parent groups. Following a feasibility study to test research procedures and the interventions, the pilot RCT participants include 60 parents of autistic children aged 4-8 years who are randomised to Predictive Parenting versus the attention control. Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events. The primary outcome is an objective measure of child behaviours that challenge during interactions with their parent and a researcher. The trial aims to provide data on recruitment, retention, completion of measures and acceptability of the intervention and research protocol, in addition to providing a preliminary indication of potential efficacy and establishing an effect size that could be used to power a larger-scale efficacy trial. We will also provide preliminary estimates of the cost-effectiveness of the interventions. ETHICS AND DISSEMINATION Ethical approval was granted from NHS Camden and Kings Cross Research Ethics Committee (ref: 16/LO/1769) along with NHS R&D approval from South London and Maudsley, Guy's and St Thomas', and Croydon Health Services NHS Trusts. The findings will be disseminated through publication in peer-reviewed journals and presentations at conferences. TRIAL REGISTRATION NUMBER ISRCTN91411078.",2019,"Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events.","['autistic children', 'pilot RCT participants include 60 parents of autistic children aged 4-8\u2009years who are randomised to', 'young autistic children']","['novel group parenting intervention', 'behavioural parenting interventions', 'Predictive Parenting versus the attention control', 'parenting intervention (Predictive Parenting']","['objective measure of child behaviours that challenge during interactions with their parent and a researcher', 'emotional and behavioural difficulties', 'child and parent outcomes, costs and service use and adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.217328,"Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Tarver', 'Affiliation': 'Department of Psychology, Aston University, School of Life and Health Sciences, Birmingham, UK.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Paris Perez', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cawthorne', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Romeo', 'Affiliation': ""Department of Health Service and Population Research, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hallett', 'Affiliation': 'Service for Complex Autism & Associated Neurodevelopmental Disorders, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'Service for Complex Autism & Associated Neurodevelopmental Disorders, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breese', 'Affiliation': 'Service for Complex Autism & Associated Neurodevelopmental Disorders, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hollett', 'Affiliation': 'Service for Complex Autism & Associated Neurodevelopmental Disorders, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Beresford', 'Affiliation': 'Social Policy Research Unit, University of York, York, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Personal Social Services Research Unit, London School of Economics, London, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Slonims', 'Affiliation': ""Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Simonoff', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Charman', 'Affiliation': 'Service for Complex Autism & Associated Neurodevelopmental Disorders, South London and Maudsley NHS Foundation Trust, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029959'] 680,30496003,Effect of Remediating Blighted Vacant Land on Shootings: A Citywide Cluster Randomized Trial.,"Objectives. To determine if remediating blighted vacant urban land reduced firearm shooting incidents resulting in injury or death. Methods. We conducted a cluster randomized controlled trial in which we assigned 541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition. The random assignment to the trial occurred in April and June 2013 and lasted until March 2015. In a difference-in-differences analysis, we assessed whether the 2 treatment conditions relative to the control condition reduced firearm shootings around vacant lots. Results. During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings. There was no evidence that the interventions displaced shootings into adjacent areas. Conclusions. Remediating vacant land with inexpensive, scalable methods, including greening or minimal mowing and trash cleanup, significantly reduced shootings that result in serious injury or death. Public Health Implications. Cities should experiment with place-based interventions to develop effective firearm violence-reduction strategies. Trial Registration. This trial was registered with the International Standard Randomized Controlled Trial Number (study ID ISRCTN92582209; http://www.isrctn.com/ISRCTN92582209).",2019,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","['541 randomly selected vacant lots in Philadelphia, Pennsylvania, to 110 geographically contiguous clusters and randomly assigned these clusters to a', 'on Shootings']","['Remediating Blighted Vacant Land', 'greening intervention, a less-intensive mowing and trash cleanup intervention, or a no-intervention control condition']",[],"[{'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205283', 'cui_str': 'Contiguous (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0017095', 'cui_str': 'Garbages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],541.0,0.318924,"During the trial, both the greening intervention, -6.8% (95% confidence interval [CI] = -10.6%, -2.7%), and the mowing and trash cleanup intervention, -9.2% (95% CI = -13.2%, -4.8%), significantly reduced shootings.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Moyer', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'MacDonald', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Ridgeway', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Branas', 'Affiliation': 'Ruth Moyer, John M. MacDonald, and Greg Ridgeway are with the Department of Criminology, University of Pennsylvania, Philadelphia. Charles C. Branas is with the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}]",American journal of public health,['10.2105/AJPH.2018.304752'] 681,31253621,A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol.,"INTRODUCTION Neoadjuvant chemotherapy (NACT) is considered the current standard for locally advanced gallbladder cancer (GBC). There is no consensus on the optimal neoadjuvant approach. A pilot study from our institution has shown improved overall survival (OS) and progression-free survival (PFS) with neoadjuvant chemoradiation (NACRT). The present randomised phase III trial is designed to compare NACRT with NACT alone and will test the superiority of chemoradiation in terms of tumour downstaging and improvement in OS. METHODS AND ANALYSIS Patients with biopsy-proven locally advanced GBC (T3-4) with predefined clinical-radiological features will be randomised to the gemcitabine-based chemotherapy-alone arm or the chemoradiation arm. Patients with resectable disease or with distant metastases will be excluded. The primary end point of the study is to compare OS between the two arms. The secondary end point was to compare PFS, R0 resection rates, acute and late toxicity, postoperative complications and quality of life between the two study arms. The trial is designed to detect an improvement in median OS by 5.5 months in the study arm (11 months in the control group, HR of 0.7) with 80.0% power at a 0.05 significance level. The resultant sample size to achieve this aim is 314 (157 in each arm) over a duration of 5 years with a 10% attrition rate. ETHICS AND DISSEMINATION The institutional ethics committee has approved this trial and will be routinely monitoring the trial at frequent intervals. The results of the study will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities. REGISTRATION The trial is registered with Clinical Trials Registry India (CTRI/2016/08/007199) and ClinicalTrials.gov (NCT02867865). This trial aims to assess the superiority of NACRT over NACT in locally advanced GBCs in terms of improvement in OS. The results of this study will define the optimal neoadjuvant approach in locally advanced GBC. TRIAL REGISTRATION NUMBER NCT02867865; Pre-results.",2019,"The trial is designed to detect an improvement in median OS by 5.5 months in the study arm (11 months in the control group, HR of 0.7) with 80.0% power at a 0.05 significance level.","['locally advanced gallbladder cancers (POLCAGB', '314 (157 in each arm) over a duration of 5 years with a 10% attrition rate', 'Patients with resectable disease or with distant metastases', 'Patients with biopsy-proven locally advanced GBC (T3-4) with predefined clinical-radiological features', 'locally advanced gallbladder cancer (GBC']","['neoadjuvant chemoradiation (NACRT', 'NACT', 'Neoadjuvant chemotherapy (NACT', 'NACRT with NACT', 'gemcitabine-based chemotherapy-alone arm or the chemoradiation arm', 'perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy', 'NACRT']","['overall survival (OS) and progression-free survival (PFS', 'PFS, R0 resection rates, acute and late toxicity, postoperative complications and quality of life', 'median OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0153452', 'cui_str': 'Cancer of Gallbladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0034380'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.196366,"The trial is designed to detect an improvement in median OS by 5.5 months in the study arm (11 months in the control group, HR of 0.7) with 80.0% power at a 0.05 significance level.","[{'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Engineer', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Patkar', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shirley Christabel', 'Initials': 'SC', 'LastName': 'Lewis', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Ashutosh Das', 'Initials': 'AD', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shetty', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Ostwal', 'Affiliation': 'Department of Medical Oncology, Gastrointestinal Disease Management Group, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Ramaswamy', 'Affiliation': 'Department of Medical Oncology, Gastrointestinal Disease Management Group, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Chopra', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Nuclear Medicine, Tata Memorial Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Patil', 'Affiliation': 'Department of Digestive Diseases and Clinical Nutrition, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shaesta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Digestive Diseases and Clinical Nutrition, Tata Memorial Centre, Mumbai, Maharashtra, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Goel', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.'}]",BMJ open,['10.1136/bmjopen-2018-028147'] 682,31319102,Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study.,"BACKGROUND Peanut allergy causes severe and fatal reactions. Current food allergen labeling does not address these risks adequately against the burden of restricting food choice for allergic patients because of limited data on thresholds of reactivity and the influence of everyday factors. OBJECTIVE We estimated peanut threshold doses for a United Kingdom population with peanut allergy and examined the effect of sleep deprivation and exercise. METHODS In a crossover study, after blind challenge, participants with peanut allergy underwent 3 open peanut challenges in random order: with exercise after each dose, with sleep deprivation preceding challenge, and with no intervention. Primary outcome was the threshold dose triggering symptoms (in milligrams of protein). Primary analysis estimated the difference between the nonintervention challenge and each intervention in log threshold (as percentage change). Dose distributions were modeled, deriving eliciting doses in the population with peanut allergy. RESULTS Baseline challenges were performed in 126 participants, 100 were randomized, and 81 (mean age, 25 years) completed at least 1 further challenge. The mean threshold was 214 mg (SD, 330 mg) for nonintervention challenges, and this was reduced by 45% (95% CI, 21% to 61%; P = .001) and 45% (95% CI, 22% to 62%; P = .001) for exercise and sleep deprivation, respectively. Mean estimated eliciting doses for 1% of the population were 1.5 mg (95% CI, 0.8-2.5 mg) during nonintervention challenge (n = 81), 0.5 mg (95% CI, 0.2-0.8 mg) after sleep, and 0.3 mg (95% CI, 0.1-0.6 mg) after exercise. CONCLUSION Exercise and sleep deprivation each significantly reduce the threshold of reactivity in patients with peanut allergy, putting them at greater risk of a reaction. Adjusting reference doses using these data will improve allergen risk management and labeling to optimize protection of consumers with peanut allergy.",2019,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"['peanut-allergic adults', '126 subjects, 100 were randomized and 81 (mean age 25y) completed at least one further challenge', 'peanut-allergic participants']","['sleep deprivation and exercise', 'Exercise and sleep deprivation']",['threshold dose triggering symptoms (mg protein'],"[{'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",100.0,0.275034,Adjusting reference doses using these data will improve allergen risk-management and labelling to optimize protection of peanut-allergic consumers.,"[{'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Dua', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom. Electronic address: shelley.dua@addenbrookes.nhs.uk.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': ""Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Durham', 'Affiliation': 'Allergy and Clinical Immunology, Section Inflammation Repair and Development National heart and Lung Institute, Faculty of Medicine, Imperial College, London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kimber', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'NIHR Southampton Respiratory Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; University of Southampton Faculty of Medicine, Southampton, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Skypala', 'Affiliation': 'National Heart and Lung Institute, Imperial College London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, United Kingdom; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ewan', 'Affiliation': ""Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; Centre of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': ""Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.038'] 683,31353217,"Efficacy and safety of intermittent preventive treatment and intermittent screening and treatment versus single screening and treatment with dihydroartemisinin-piperaquine for the control of malaria in pregnancy in Indonesia: a cluster-randomised, open-label, superiority trial.","BACKGROUND Plasmodium falciparum and Plasmodium vivax infections are important causes of adverse pregnancy outcomes in the Asia-Pacific region. We hypothesised that monthly intermittent preventive treatment (IPT) or intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine is more effective in reducing malaria in pregnancy than the existing single screening and treatment (SST) strategy, which is used to screen women for malaria infections at the first antenatal visit followed by passive case detection, with management of febrile cases. METHODS We did an open-label, three-arm, cluster-randomised, superiority trial in Sumba (low malaria transmission site) and Papua (moderate malaria transmission site), Indonesia. Eligible participants were 16-30 weeks pregnant. Clusters (antenatal clinics with at least ten new pregnancies per year matched by location, size, and malaria risk) were randomly assigned (1:1:1) via computer-generated lists to IPT, IST, or SST clusters. In IPT clusters, participants received the fixed-dose combination of dihydroartemisinin-piperaquine (4 and 18 mg/kg per day). In IST clusters, participants were screened with malaria rapid diagnostic tests once a month, whereas, in SST clusters, they were screened at enrolment only. In all groups, participants with fever were tested for malaria. Any participant who tested positive received dihydroartemisinin-piperaquine regardless of symptoms. The primary outcome was malaria infection in the mother at delivery. Laboratory staff were unaware of group allocation. Analyses included all randomly assigned participants contributing outcome data and were adjusted for clustering at the clinic level. This trial is complete and is registered with ISRCTN, number 34010937. FINDINGS Between May 16, 2013, and April 21, 2016, 78 clusters (57 in Sumba and 21 in Papua) were randomly assigned to SST, IPT, or IST clusters (26 clusters each). Of 3553 women screened for eligibility, 2279 were enrolled (744 in SST clusters, 681 in IPT clusters, and 854 in IST clusters). At enrolment, malaria prevalence was lower in IST (5·7%) than in SST (12·6%) and IPT (10·6%) clusters. At delivery, malaria prevalence was 20·2% (128 of 633) in SST clusters, compared with 11·6% (61 of 528) in IPT clusters (relative risk [RR] 0·59, 95% CI 0·42-0·83, p=0·0022) and 11·8% (84 of 713) in IST clusters (0·56, 0·40-0·77, p=0·0005). Conditions related to the pregnancy, the puerperium, and the perinatal period were the most common serious adverse events for the mothers, and infections and infestations for the infants. There were no differences between groups in serious adverse events in the mothers or in their infants. INTERPRETATION IST was associated with a lower prevalence of malaria than SST at delivery, but the prevalence of malaria in this group was also lower at enrolment, making interpretation of the effect of IST challenging. Further studies with highly sensitive malaria rapid diagnostic tests should be considered. Monthly IPT with dihydroartemisinin-piperaquine is a promising alternative to SST in areas in the Asia-Pacific region with moderate or high transmission of malaria. FUNDING Joint Global Health Trials Scheme of the Medical Research Council, Department for International-Development, and the Wellcome Trust.",2019,"There were no differences between groups in serious adverse events in the mothers or in their infants. ","['3553 women screened for eligibility, 2279 were enrolled (744 in SST clusters, 681 in IPT clusters, and 854 in IST clusters', 'Clusters (antenatal clinics with at least ten new pregnancies per year matched by location, size, and malaria risk', 'Eligible participants were 16-30 weeks pregnant', 'participants with fever were tested for malaria', 'Between May 16, 2013, and April 21, 2016, 78 clusters (57 in Sumba and 21 in Papua', 'malaria in pregnancy in Indonesia']","['intermittent preventive treatment and intermittent screening and treatment versus single screening and treatment with dihydroartemisinin-piperaquine', 'monthly intermittent preventive treatment (IPT) or intermittent screening and treatment (IST) with dihydroartemisinin-piperaquine', 'dihydroartemisinin-piperaquine']","['malaria prevalence', 'serious adverse events', 'Efficacy and safety', 'malaria infection in the mother at delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0454741', 'cui_str': 'Sumba (geographic location)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",2279.0,0.251284,"There were no differences between groups in serious adverse events in the mothers or in their infants. ","[{'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Jeanne R', 'Initials': 'JR', 'LastName': 'Poespoprodjo', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia; Timika Malaria Research Programme, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pace', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Theda', 'Initials': 'T', 'LastName': 'Lukito', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Sylvia S', 'Initials': 'SS', 'LastName': 'Maratina', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Malaria and Vector Resistance Laboratory, Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Santana-Morales', 'Affiliation': 'Department of Obstetrics and Gynecology, Pediatrics, Preventive Medicine and Public Health, Toxicology, Legal and Forensic Medicine and Parasitology, University Institute of Tropical Diseases and Public Health of the Canary Islands, University of la Laguna, Tenerife, Spain; Network Biomedical Research on Tropical Diseases, RICET, Madrid, Spain.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Adams', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Vera T', 'Initials': 'VT', 'LastName': 'Unwin', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Williams', 'Affiliation': 'Centre for Drugs and Diagnostics Research, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Smedley', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Faragher', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Price', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: feiko.terkuile@lstmed.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30156-2'] 684,31129600,Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol.,"INTRODUCTION Physically active cancer survivors have substantially less cancer recurrence and improved survival compared with those who are inactive. However, the majority of survivors (70%-90%) are not meeting the physical activity (PA) guidelines. There are also significant geographic inequalities in cancer survival with poorer survival rates for the third of Australians who live in non-metropolitan areas compared with those living in major cities. The primary objective of the trial is to increase moderate-to-vigorous PA (MVPA) among cancer survivors living in regional and remote Western Australia. Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors. Tertiary objectives are to assess the effectiveness of the health action process approach (HAPA) model variables, on which the intervention is based, to predict change in MVPA. METHODS AND ANALYSIS Eighty-six cancer survivors will be randomised into either the intervention or control group. Intervention group participants will receive a Fitbit and up to six telephone health-coaching sessions. MVPA (using Actigraph), QoL and psychological variables (based on the HAPA model via questionnaire) will be assessed at baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up). A general linear mixed model will be used to assess the effectiveness of the intervention. ETHICS AND DISSEMINATION Ethics approval has been obtained from St John of God Hospital Subiaco (HREC/#1201). We plan to submit a manuscript of the results to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital research conferences. TRIAL REGISTRATION NUMBER ACTRN12618001743257; pre-results, U1111-1222-5698.",2019,"Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors.","['Eighty-six cancer survivors', 'cancer survivors living in regional and remote Western Australia']",['Fitbit and up to six telephone health-coaching sessions'],"['cancer recurrence and improved survival', 'survival rates', 'MVPA (using Actigraph), QoL and psychological variables', 'sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL', 'moderate-to-vigorous PA (MVPA']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.157965,"Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hardcastle', 'Affiliation': 'School of Psychology, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hince', 'Affiliation': 'Institute of Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Jiménez-Castuera', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Badajoz, Spain.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Boyle', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Makin', 'Affiliation': 'General Surgery, St John of God Murdoch Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Tan', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Salfinger', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Ganendra Raj', 'Initials': 'GR', 'LastName': 'Mohan', 'Affiliation': 'Hollywood Private Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levitt', 'Affiliation': 'St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cohen', 'Affiliation': 'School of Medicine, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'School of Medicine, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Platell', 'Affiliation': 'School of Medicine, University of Western Australia, Crawley, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-028369'] 685,31594555,The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT.,"BACKGROUND Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. OBJECTIVE To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care. DESIGN A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey. SETTING Four general medical wards at district general hospitals in England. PARTICIPANTS There were 65 participants (control, n  = 36; intervention, n  = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. INTERVENTION The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen. MAIN OUTCOME MEASURES Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and ' howRwe '. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. RESULTS Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden. LIMITATIONS The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not. CONCLUSIONS This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation. TRIAL REGISTRATION Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.",2019,"Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented.","['Four general medical wards at district general hospitals in England', '65 participants (control, n \u2009=\u200936; intervention, n \u2009=\u200929', 'acutely unwell patient population', 'National Institute for Health Research (NIHR', 'hospital inpatients with uncertain recovery nearing the end of life', '24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed', '65 patients', 'semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews', 'Patients admitted to hospital with a terminal illness']",[],"['Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability', 'recruitment rate', ""Palliative care Outcome Scale patient/family anxiety and communication subscale and ' howRwe ""]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation (regime/therapy)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness (finding)'}]",[],"[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",23.0,0.0682041,"Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Koffman', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yorganci', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Fliss', 'Initials': 'F', 'LastName': 'Murtagh', 'Affiliation': 'Wolfson Palliative Care Research Centre, University of Hull, Hull, UK.'}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Patient and public representative.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Ewart', 'Affiliation': 'Patient and public representative.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23550'] 686,31227537,Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study): protocol of a randomised controlled trial.,"INTRODUCTION After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems. METHODS AND ANALYTICS One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group is asked to maintain their habitual activity pattern during 6 months. The primary outcome (verbal learning) is measured at baseline and 6 months. Further measurements include online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness. The MRI scans and blood sampling will be used to gain insight into underlying mechanisms. At 18 months online neuropsychological tests, self-reported cognitive complaints and patient-reported outcomes will be repeated. ETHICS AND DISSEMINATION Study results may impact usual care if physical exercise improves cognitive functioning for breast cancer survivors. TRIAL REGISTRATION NUMBER NTR6104.",2019,"While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment.","['patients with breast cancer (PAM study', 'healthy older adults and people with mild cognitive impairment', 'One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis', 'chemotherapy-exposed patients with breast cancer with cognitive problems', 'patients with breast cancer experience cognitive problems', 'breast cancer survivors']","['exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour', 'chemotherapy', 'physical exercise', 'exercise intervention or a control group', 'Nordic or power walking']","['cognitive functioning and brain measures', 'primary outcome (verbal learning', 'online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness', 'cognitive function and brain measures', 'cognitive functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034380'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",180.0,0.0747321,"While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment.","[{'ForeName': 'Lenja', 'Initials': 'L', 'LastName': 'Witlox', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sanne B', 'Initials': 'SB', 'LastName': 'Schagen', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel B', 'Initials': 'MB', 'LastName': 'de Ruiter', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Mirjam I', 'Initials': 'MI', 'LastName': 'Geerlings', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Emmie W', 'Initials': 'EW', 'LastName': 'Koevoets', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Stuiver', 'Affiliation': 'Center for Quality of Life, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Center for Quality of Life, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Miranda J', 'Initials': 'MJ', 'LastName': 'Velthuis', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Job A M van der', 'Initials': 'JAMV', 'LastName': 'Palen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Jobsen', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-028117'] 687,31122224,Effect of a participatory intervention in women's self-help groups for the prevention of chronic suppurative otitis media in their children in Jumla Nepal: a cluster-randomised trial.,"BACKGROUND Chronic suppurative otitis media (CSOM) causes preventable deafness and disproportionately affects children living in poverty. Our hypothesis was that health promotion in women's groups would increase their knowledge, attitudes and practices (KAP) regarding ear disease and reduce the prevalence of CSOM in their children. METHODS We did a cluster randomised trial in two village development committees (VDCs) in Jumla, Nepal. In July 2014, 30 women's groups were randomly allocated to intervention or control, stratified by VDC and distance to the road. The intervention groups participated in three sessions of health promotion using the WHO Hearing and Ear Care Training Resource Basic Level. The primary outcome was women's KAP score and the secondary outcome was prevalence of CSOM in their children at 12 month follow-up. Analyses were by intention to treat. Participants and the research team were not masked to allocation. RESULTS In June and July 2014 we recruited 508 women and 937 of their children. 12 months later there was no difference in the women's KAP score (mean difference 0.14, 95% CI - 0.1 to 0.38, P = 0.25) or the prevalence of CSOM in their children (OR 1.10, 95%CI 0.62 to 1.84, P = 0.75) between intervention and control groups. However, overall, there was a significant improvement in the KAP score (mean difference - 0.51, 95% CI - 0.71,to - 0.31, P < 0.0001) and in the prevalence of CSOM from baseline 11.2% to follow-up 7.1% (P < 0.0001). CONCLUSIONS Health promotion in women's groups did not improve maternal KAP or reduce prevalence of CSOM. Over time there was a significant improvement in women's KAP score and reduction in the prevalence of CSOM which may be attributable to our presence in the community offering treatment to affected children, talking to their parents and providing ciprofloxacin drops to the local health posts. More research is needed in low resource settings to test our findings. TRIAL REGISTRATION Australia and New Zealand Clinical Trial Registry 12,614,000,231,640 ; Date of registration: 5.3.2014: Prospectively registered.",2019,"Over time there was a significant improvement in women's KAP score and reduction in the prevalence of CSOM which may be attributable to our presence in the community offering treatment to affected children, talking to their parents and providing ciprofloxacin drops to the local health posts.","['two village development committees (VDCs) in Jumla, Nepal', ""In July 2014, 30 women's groups"", 'In June and July 2014 we recruited 508 women and 937 of their children', 'Chronic suppurative otitis media (CSOM', 'children living in poverty', ""women's self-help groups for the prevention of chronic suppurative otitis media in their children in Jumla Nepal""]","['ciprofloxacin', 'health promotion using the WHO Hearing and Ear Care Training Resource Basic Level', 'participatory intervention']","['knowledge, attitudes and practices (KAP) regarding ear disease', 'KAP score', 'maternal KAP or reduce prevalence of CSOM', 'prevalence of CSOM', ""women's KAP score""]","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0242543', 'cui_str': ""Women's Groups""}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media (disorder)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0150192', 'cui_str': 'Ear care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013447', 'cui_str': 'Otologic Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",508.0,0.221469,"Over time there was a significant improvement in women's KAP score and reduction in the prevalence of CSOM which may be attributable to our presence in the community offering treatment to affected children, talking to their parents and providing ciprofloxacin drops to the local health posts.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales Sydney, High St, Kensington, NSW, 2052, Australia. susan.clarke@unswalumni.com.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richmond', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales Sydney, High St, Kensington, NSW, 2052, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Worth', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales Sydney, High St, Kensington, NSW, 2052, Australia.'}, {'ForeName': 'Rajendra', 'Initials': 'R', 'LastName': 'Wagle', 'Affiliation': 'Institute of Medicine, Tribhuvan University, Maharaganj, Kathmandu, Nepal.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 15 Broadway, Ultimo, NSW, 2007, Australia.'}]",BMC pediatrics,['10.1186/s12887-019-1539-y'] 688,30971600,A comparative study of safety and efficacy of ultrasound-guided infra-clavicular axillary vein cannulation versus ultrasound-guided internal jugular vein cannulation in adult cardiac surgical patients.,"Background Ultrasound (US)-guided internal jugular vein (IJV) cannulation is a widely accepted standard procedure. The axillary vein (AV) in comparison to the subclavian vein is easily visualized, but its cannulation is not extensively studied in cardiac patients. Aims This study is an attempt to study the efficacy of real-time US-guided axillary venous cannulation as a safe alternative for the time-tested US-guided IJV cannulation. Design This is a prospective randomized controlled study. Materials and Methods A total of 100 adult patients scheduled for cardiac surgery were divided equally in Group A-US-guided IJV cannulation, and Group B-US-guided axillary venous cannulation. Under local anesthesia and real-time US guidance the IJV or AV was secured. The access time, guidewire time, and procedure time were noted. Furthermore, the number of needle attempts, malposition, change of site, and complications were noted. Results The data were analyzed for 49 patients in Group A and 48 patients in the Group B due to exclusions. The access time and the guidewire time were comparable in both groups. The first attempt needle puncture was successful for the IJV group in 98% of patients in comparison to 95% of patients in Group B. Guidewire was passed in the first attempt in 94% in Group A and 89% in the Group B. Except for arterial puncture in one case in group A, the complications were insignificant in both groups. Conclusion The study shows that the US-guided AV cannulation may serve as an effective alternative to the IJV cannulation in cardiac surgery.",2019,The first attempt needle puncture was successful for the IJV group in 98% of patients in comparison to 95% of patients in Group B. Guidewire was passed in the first attempt in 94% in Group A and 89% in the Group B.,"['100 adult patients scheduled for cardiac surgery', '49 patients in Group A and 48 patients in the Group B due to exclusions', 'adult cardiac surgical patients']","['US-guided IJV cannulation, and Group B-US-guided axillary venous cannulation', '\n\n\nUltrasound (US)-guided internal jugular vein (IJV) cannulation', 'US-guided AV cannulation', 'real-time US-guided axillary venous cannulation', 'ultrasound-guided infra-clavicular axillary vein cannulation versus ultrasound-guided internal jugular vein cannulation']","['number of needle attempts, malposition, change of site, and complications', 'access time, guidewire time, and procedure time', 'access time and the guidewire time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0333042', 'cui_str': 'Malposition (morphologic abnormality)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",100.0,0.0174715,The first attempt needle puncture was successful for the IJV group in 98% of patients in comparison to 95% of patients in Group B. Guidewire was passed in the first attempt in 94% in Group A and 89% in the Group B.,"[{'ForeName': 'Prajakta D', 'Initials': 'PD', 'LastName': 'Shinde', 'Affiliation': 'Department of Anaesthesiology and Cardiac Surgery, Fortis Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Amish', 'Initials': 'A', 'LastName': 'Jasapara', 'Affiliation': 'Department of Anaesthesiology and Cardiac Surgery, Fortis Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kishan', 'Initials': 'K', 'LastName': 'Bansode', 'Affiliation': 'Department of Anaesthesiology and Cardiac Surgery, Fortis Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bunage', 'Affiliation': 'Department of Anaesthesiology and Cardiac Surgery, Fortis Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Anvay', 'Initials': 'A', 'LastName': 'Mulay', 'Affiliation': 'Department of Anaesthesiology and Cardiac Surgery, Fortis Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vijay L', 'Initials': 'VL', 'LastName': 'Shetty', 'Affiliation': 'Department of Anaesthesiology, Fortis Hospital, Mumbai, Maharashtra, India.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_24_18'] 689,31082898,Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension: A Randomized Trial.,"OBJECTIVE To investigate the safety and efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT) (ClinicalTrials.gov number,01290172). BACKGROUND In LT, portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT. METHODS Thirty-three patients undergoing LT for ESLD and CSPH were randomized double-blindly to receive somatostatin or placebo (2:1). The study drug was administered intraoperatively as 5-mL bolus (somatostatin: 500 μg), followed by a 2.5 mL/h infusion (somatostatin: 250 μg/h) for 5 days. Hepatic and systemic hemodynamics were measured, along with liver function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) was analyzed through histological and protein expression analysis. RESULTS Twenty-nine patients (18 receiving somatostatin, 11 placebo) were included in the final analysis. Ten patients responded to somatostatin bolus, with a significant decrease in hepatic venous portal gradient (HVPG) and portal flow of -28.3% and -29.1%, respectively. At graft reperfusion, HVPG was lower in patients receiving somatostatin (-81.7% vs -58.8%; P = 0.0084), whereas no difference was observed in the portal flow (P = 0.4185). Somatostatin infusion counteracted the decrease in arterial flow (-10% vs -45%; P = 0.0431). There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival. CONCLUSIONS Somatostatin infusion during LT in patients with CSPH is safe, reduces the HVPG, and preserves the arterial inflow to the graft. This study establishes the efficacy of somatostatin as a liver inflow modulator.",2019,"There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival. ","['Liver-transplant Recipients With Severe Portal Hypertension', 'patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT) (ClinicalTrials.gov number,01290172', 'Thirty-three patients undergoing LT for ESLD and CSPH', 'Twenty-nine patients (18 receiving somatostatin, 11']","['somatostatin or placebo', 'Somatostatin', 'somatostatin', 'placebo']","['hepatic venous portal gradient (HVPG) and portal flow', 'ischemia-reperfusion injury (IRI', 'severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival', 'portal flow', 'graft function and survival', 'Hepatic and systemic hemodynamics', 'arterial flow']","[{'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0765956', 'cui_str': '4-(3-chlorophenylsulfanyl)piperidine hydrochloride'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}]","[{'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0429856', 'cui_str': 'Arterial flow (observable entity)'}]",33.0,0.558437,"There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival. ","[{'ForeName': 'Roberto Ivan', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Vanlander', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University, Naples, Italy.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Van Limmen', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Scudeller', 'Affiliation': 'Clinical Epidemiology Unit, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Heyse', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'De Baerdemaeker', 'Affiliation': 'Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Croo', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Voet', 'Affiliation': 'Department of Sonography, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Praet', 'Affiliation': 'Department of Anatomopathology, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hoorens', 'Affiliation': 'Department of Anatomopathology, Ghent University Hospital Medical School, Ghent, Belgium.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Antoniali', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Codarin', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tell', 'Affiliation': 'Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Reynaert', 'Affiliation': 'Department of Basic Biomedical Sciences, Liver Cell Biology Laboratory, Vrije Universiteit Brussel (VUB), Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Colle', 'Affiliation': 'Department of Internal Medicine, Ghent University Hospital Medical School, Ghent. Belgium.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Sainz-Barriga', 'Affiliation': 'Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium.'}]",Annals of surgery,['10.1097/SLA.0000000000003062'] 690,31217318,Survey of the effect of viewing an online e-cigarette advertisement on attitudes towards cigarette and e-cigarette use in adults located in the UK and USA: a cross-sectional study.,"OBJECTIVES This study explored the potential for e-cigarette advertisements to (1) enhance attitudes towards cigarettes and/or (2) reduce barriers to e-cigarettes uptake. The study tested whether exposure to an online electronic cigarette advertisement changed attitudes towards cigarettes and e-cigarettes in smokers, non-smokers, e-cigarette users and dual users (smokers who also use e-cigarettes). DESIGN Cross-sectional study SETTING: Online survey PARTICIPANTS: Adults (n=964) aged 18 to 65 years old (M=36 years, SD=11.6) from the UK and USA. Participants were grouped into current non-smokers, e-cigarette users, dual users and smokers. INTERVENTIONS Participants viewed 1 of 15 randomly assigned online e-cigarette advertisements. PRIMARY MEASURES Three single seven-point Likert scales measuring health, desirability, social acceptability were completed pre and post advertisement exposure. RESULTS Post exposure all smoking groups showed a decrease or no change in how socially acceptable or desirable they rated cigarettes. Paradoxically, dual users rated cigarettes as being significantly healthier after viewing the advertisement (p=0.01) while all other smoking group ratings remained the same. There was an increase or no change in how all smoking groups perceived the healthiness and desirability of e-cigarettes CONCLUSIONS: We observed no evidence that exposure to an e-cigarette advertisement renormalises or encourages smoking in smokers, non-smokers or e-cigarette users. However, there is some indication that viewing an e-cigarette advertisement may increase duals users' perceptions of the health of smoking.",2019,"Paradoxically, dual users rated cigarettes as being significantly healthier after viewing the advertisement (p=0.01) while all other smoking group ratings remained the same.","['Participants were grouped into current non-smokers, e-cigarette users, dual users and smokers', ' Adults (n=964) aged 18 to 65 years old (M=36 years, SD=11.6) from the UK and USA', 'in smokers, non-smokers, e-cigarette users and dual users (smokers who also use e-cigarettes', 'adults located in the UK and USA']","['online electronic cigarette advertisement changed attitudes towards cigarettes and e-cigarettes', 'viewing an online e-cigarette advertisement']","['Likert scales measuring health, desirability, social acceptability', 'socially acceptable or desirable they rated cigarettes']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425311', 'cui_str': 'Current non-smoker (finding)'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",964.0,0.0176766,"Paradoxically, dual users rated cigarettes as being significantly healthier after viewing the advertisement (p=0.01) while all other smoking group ratings remained the same.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Booth', 'Affiliation': 'Psychological Sciences Department, Applied Health and Communities College, School of Psychology, The University of East London, London, UK.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Albery', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Frings', 'Affiliation': 'Division of Psychology, School of Applied Sciences, London South Bank University, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027525'] 691,30962268,B-cell dynamics during experimental endotoxemia in humans.,"Recently, B cells with regulatory functions suppressing T-cell immunity were identified. Inflammation in the context of sepsis is characterized by a profound immune dysfunction increasing the patient's risk for additional infections. The impact of endotoxemia on B-cell dynamics, regulatory B cells (Breg) and its contribution to immune dysfunction is unknown. It is the aim of the present study to characterize the dynamics of the B-cell compartment and Breg in an experimental human endotoxemia model.In this randomized placebo-controlled cross-over study, 20 healthy males received an intravenous injection of endotoxin ( Escherichia coli lipopolysaccharide, LPS, 0.8 ng/kg body weight) or placebo (saline 0.9%) on two otherwise identical study days. B cells were analyzed by flow cytometry at baseline and repeatedly up to 72 h after endotoxin/placebo injection.Absolute CD19 + B cells counts showed a significant decrease 3 h after endotoxin injection. Memory B cells were partially depleted from the circulation; the total number of Breg was significantly diminished 3 h after LPS challenge. Production of anti-inflammatory interleukin (IL)-10 (IL-10) by Breg was unaltered after LPS challenge. Systemic B-cell activating factor (BAFF) levels were significantly increased with a maximum after 24 h and remained increased up to 72 h post-injection.Endotoxemia causes a transient depletion of memory B cells and Breg from the circulation. However, the functional capacity of B cells to produce IL-10 is not impaired.",2019,Production of anti-inflammatory interleukin (IL)-10 (IL-10) by Breg was unaltered after LPS challenge.,"['20 healthy males', 'humans']","['intravenous injection of endotoxin ( Escherichia coli lipopolysaccharide, LPS, 0.8 ng/kg body weight) or placebo', 'endotoxin/placebo', 'placebo', 'Systemic B-cell activating factor ']","['Memory B cells', 'BAFF) levels', 'total number of Breg', 'Absolute CD19 + B cells counts', 'Production of anti-inflammatory interleukin (IL)-10 (IL-10']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",20.0,0.213809,Production of anti-inflammatory interleukin (IL)-10 (IL-10) by Breg was unaltered after LPS challenge.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brinkhoff', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany benjamin.wilde@uk-essen.de alexandra.brinkhoff@uk-essen.de.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Sieberichs', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Dolff', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shilei', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Korth', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wilde', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany benjamin.wilde@uk-essen.de alexandra.brinkhoff@uk-essen.de.'}]",Bioscience reports,['10.1042/BSR20182347'] 692,30971593,Terlipressin versus norepinephrine to prevent milrinone-induced systemic vascular hypotension in cardiac surgery patient with pulmonary hypertension.,"Introduction Milrinone at inotropic doses requires the addition of a vasoconstrictive drug. We hypothesized that terlipressin use could selectively recover the systemic vascular hypotension induced by milrinone without increasing the pulmonary vascular resistance (PVR) and mean pulmonary artery pressure (MPAP) as norepinephrine in cardiac surgery patients. Patients and Methods Patients with pulmonary hypertension were enrolled in this study. At the start of rewarming a milrinone 25 μg/kg bolus over 10 min followed by infusion at the rate of 0.25 μg/kg/min. Just after the loading dose of milrinone, the patients were randomized to receive norepinephrine infusion at a dose of 0.1 μg/kg/min (norepinephrine group) or terlipressin infusion at a dose of 2 μg/kg/h (terlipressin group). Heart rate, mean arterial blood pressure (MAP), central venous pressure, MPAP, systemic vascular resistance (SVR), PVR, cardiac output were measured after induction of anesthesia, after loading dose of milrinone, during skin closure, and in the intensive care unit till 24 h. Results Milrinone decreased MAP (from 79.56 ± 4.5 to 55.21 ± 2.1 and from 78.46 ± 3.3 to 54.11 ± 1.1) and decreased the MPAP (from 59.5 ± 3.5 to 25.4 ± 2.6 and from 61.3 ± 5.2 to 25.1 ± 2.3) in both groups. After norepinephrine, there was an increase in the MAP which is comparable to terlipressin group (P > 0.05). Terlipressin group shows a significant lower MPAP than norepinephrine group (24.5 ± 1.4 at skin closure vs. 43.3 ± 2.1, than 20.3 ± 2.1 at 24 h vs. 39.8 ± 3.8 postoperatively). There is a comparable increase in the SVR in both group, PVR showed a significant increase in the norepinephrine group compared to the terlipressin group (240.5 ± 23 vs. 140.6 ± 13 at skin closure than 190.3 ± 32 vs. 120.3 ± 10 at 24 h postoperatively). Conclusion The use of terlipressin after milrinone will reverse systemic hypotension with lesser effect on the pulmonary artery pressure.",2019,"There is a comparable increase in the SVR in both group, PVR showed a significant increase in the norepinephrine group compared to the terlipressin group (240.5 ± 23 vs. 140.6 ± 13 at skin closure than 190.3 ± 32 vs. 120.3 ± 10 at 24 h postoperatively). ","['cardiac surgery patient with pulmonary hypertension', 'cardiac surgery patients', 'Patients and Methods\n\n\nPatients with pulmonary hypertension']","['terlipressin', 'milrinone', 'Milrinone', 'Terlipressin versus norepinephrine', 'norepinephrine infusion at a dose of 0.1 μg/kg/min (norepinephrine group) or terlipressin infusion', 'Terlipressin', 'norepinephrine']","['pulmonary vascular resistance (PVR) and mean pulmonary artery pressure (MPAP', 'MAP', 'pulmonary artery pressure', 'SVR', 'systemic vascular hypotension', 'Heart rate, mean arterial blood pressure (MAP), central venous pressure, MPAP, systemic vascular resistance (SVR), PVR', ' cardiac output', 'MPAP']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}]",,0.270077,"There is a comparable increase in the SVR in both group, PVR showed a significant increase in the norepinephrine group compared to the terlipressin group (240.5 ± 23 vs. 140.6 ± 13 at skin closure than 190.3 ± 32 vs. 120.3 ± 10 at 24 h postoperatively). ","[{'ForeName': 'Mai Mohsen', 'Initials': 'MM', 'LastName': 'Abdelazziz', 'Affiliation': 'Department of Anesthesia, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Hadil Magdi', 'Initials': 'HM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Anesthesia, Ain Shams University, Cairo, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_83_18'] 693,30971596,The effect of perioperative magnesium sulfate on blood sugar in patients with diabetes mellitus undergoing cardiac surgery: A double-blinded randomized study.,"Objective The aim of the present study was to evaluate the perioperative effect of magnesium infusion on blood sugar level in patients with diabetes mellitus undergoing cardiac surgery. Design This was a double-blind randomized study. Setting The study was conducted at cardiac center. Patients The study included 122 adult patients. Intervention Group M - The patients received a continuous infusion of magnesium sulfate (without a loading dose) at 15 mg/kg/h. The infusion rate was started 20 min before induction maintained during surgery and the first postoperative 24 h. The medication was prepared by adding 5 g magnesium sulfate in 50 ml syringe. Group C - The patients received equal amount of normal saline. Measurements The monitors included heart rate, mean arterial blood pressure, central venous pressure, urine output, blood levels of magnesium, sugar, and potassium. Results The blood sugar level and the required insulin significantly decreased with Group M than Group C (P < 0.05). There were minimal changes in the potassium level in Group M, but potassium decreased in patients of Group C (P < 0.05). The amount of urine output was too much higher in Group M than Group C (P < 0.05). The pharmacological and mechanical support significantly decreased with Group M than Group C (P < 0.05). The hospital and Intensive Care Unit length of stay significantly decreased with Group M than Group C (P < 0.05). Conclusion The magnesium sulfate produced a better-controlled effect on the blood sugar level. It decreased the requirement of insulin infusion and minimized the changes in the blood level of potassium.",2019,"The hospital and Intensive Care Unit length of stay significantly decreased with Group M than Group C (P < 0.05). ","['Patients', 'patients with diabetes mellitus undergoing cardiac surgery', '122 adult patients']","['normal saline', 'magnesium sulfate', 'perioperative magnesium sulfate', 'continuous infusion of magnesium sulfate', 'magnesium infusion']","['amount of urine output', 'potassium level', 'blood sugar', 'blood sugar level and the required insulin', 'blood sugar level', 'infusion rate', 'hospital and Intensive Care Unit length of stay', 'heart rate, mean arterial blood pressure, central venous pressure, urine output, blood levels of magnesium, sugar, and potassium', 'blood level of potassium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0428289', 'cui_str': 'Finding of potassium level (finding)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]",122.0,0.107169,"The hospital and Intensive Care Unit length of stay significantly decreased with Group M than Group C (P < 0.05). ","[{'ForeName': 'Rabie', 'Initials': 'R', 'LastName': 'Soliman', 'Affiliation': 'Department of Anesthesia, Cairo University, Cairo, Egypt; Department of Cardiac Anesthesia, Cardiac Center, Aldar Hospital, Almadinah Almonwarah, Saudi Arabia.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Nofal', 'Affiliation': 'Department of Cardiac Surgery, Cardiac Center, Aldar Hospital, Almadinah Almonwarah, Saudi Arabia; National Heart Institute, Giza, Egypt.'}]",Annals of cardiac anaesthesia,['10.4103/aca.ACA_32_18'] 694,31689640,Protective behavioral strategies predict alcohol-related problems among injured patients following a brief intervention.,"BACKGROUND Alcohol protective behavioral strategies (PBS) have been proposed as mechanisms of change underlying interventions for reducing alcohol use and alcohol-related problems. Few studies have examined PBS use among non-college student populations and no study has examined PBS use among adult injured patients. The current study tested types of PBS as mediators of the effects of a brief motivational intervention (BMI) delivered in the trauma care setting on alcohol-related problems. METHOD Secondary data analyses were conducted using data from a multisite randomized controlled trial of brief intervention in the trauma care setting. The current study used data from a subset of participants who reported having consumed alcohol at least once at 3-month follow-up (N = 324). Following a baseline assessment, participants were assigned to either brief advice (BA; n = 107), BMI (n = 119), or BMI with a telephone booster (BMI + B; n = 98). Participants completed measures of PBS at 3-month follow-up and of alcohol-related problems at baseline and 6-month follow-up. A multiple mediation model was conducted to simultaneously test the mediation effects of types of PBS. RESULTS BMI and BMI + B relative to BA did not increase PBS use. However, more frequent use of certain types of PBS at 3-month follow-up were predictors of greater reductions in alcohol-related problems from baseline to 6-month follow-up. There were no statistically significant mediation effects. CONCLUSIONS The present study suggests that PBS use reduces alcohol-related problems among trauma patients and implications for future studies are discussed.",2019,"There were no statistically significant mediation effects. ","['injured patients following a brief intervention', 'adult injured patients', 'participants who reported having consumed alcohol at least once at 3-month follow-up (N\u202f=\u202f324']","['PBS', 'motivational intervention (BMI', 'Alcohol protective behavioral strategies (PBS']",['PBS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]",[],324.0,0.0369062,"There were no statistically significant mediation effects. ","[{'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA. Electronic address: dkrichards2@utep.edu.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Pearson', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Boulevard Southeast MSC11-6280, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Osvaldo F', 'Initials': 'OF', 'LastName': 'Morera', 'Affiliation': 'Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.06.037'] 695,31689641,A community pharmacy-led intervention for opioid medication misuse: A small-scale randomized clinical trial.,"BACKGROUND Stemming the opioid epidemic requires testing novel interventions. Toward this goal, feasibility and acceptability of a Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention was examined along with its impact on medication misuse and concomitant health conditions. METHODS We conducted a two-group randomized trial in 2 community pharmacies. We screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index. Participants were assigned to standard medication counseling (SMC) or SMC + BMI-MTM (referred to as BMI-MTM herein). BMI-MTM consists of a pharmacist-led medication counseling/brief motivational session and 8-weekly patient navigation sessions. Assessments were at baseline, 2-, and 3-months. Primary outcomes included feasibility, acceptability, and mitigation of opioid medication misuse. Secondary outcomes included pain and depression. Outcomes were analyzed with descriptive and multivariable statistics (intent-to-treat [ITT] and adjusted for number of sessions completed [NUMSESS]). RESULTS Thirty-two participants provided informed consent (74.4% consent rate; SMC n = 17, BMI-MTM n = 15; 3-month assessment retention ≥93%). Feasibility was demonstrated by all BMI-MTM recipients completing the pharmacist session and an average of 7 navigation sessions. BMI-MTM recipients indicated ≥4.2 (5 maximum) level of satisfaction with the pharmacist-led session, and 92.4% were satisfied with navigation sessions. Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001. NUMSESS AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = 14.0, 95% CI = 3.28, 24.8, p = 0.01), and depression (ITT: B= -0.44; 95% CI=-0.65, -0.22; p < 0.001. NUMSESS B= -0.64; 95% CI=-0.82, -0.46; p < 0.001). CONCLUSIONS BMI-MTM is a feasible misuse intervention associated with superior satisfaction and outcomes than SMC. Future research should test BMI-MTM in a large-scale, fully-powered trial.",2019,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001. NUMSESS AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","['screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index', '2 community pharmacies']","['standard medication counseling (SMC) or SMC\u202f+\u202fBMI-MTM', 'Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention']","['number of sessions completed [NUMSESS', 'pain and depression', 'feasibility, acceptability, and mitigation of opioid medication misuse', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",32.0,0.100783,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001. NUMSESS AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Cochran', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA; University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: jerry.cochran@hsc.utah.edu.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: QIC31@pitt.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Field', 'Affiliation': 'University of Texas, El Paso, Department of Psychology, Psychology Building, Room 112 500 W University, El Paso, Texas, 79902, USA. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Seybert', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmacy and Therapeutics, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: seyberta@pitt.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hruschak', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: VJH6@pitt.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Falk Pharmacy, UPMC 3601 Fifth Ave, Pittsburgh, PA 15213, USA. Electronic address: jabera@upmc.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA. Electronic address: Adam.Gordon@hsc.utah.edu.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tarter', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmaceutical Sciences, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: tarter@pitt.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107570'] 696,31704382,Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.,"OBJECTIVES To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. METHODS Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254). RESULTS Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. CONCLUSIONS Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.",2019,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","['535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of', 'patients with OUD']","['BUP-NX', 'XR-NTX', 'buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'naltrexone and buprenorphine-naloxone']","['BUP-NX', 'XR-NTX']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],535.0,0.0141898,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol and Substance Use Studies, Graduate School of Applied and Professional Psychology, Rutgers University, New Brunswick, United States. Electronic address: lesia.ruglass@rutgers.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Biostatistics Department, Mailman School of Public Health, Columbia University, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, United States.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School and McLean Hospital, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107649'] 697,31707827,Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA.,"BACKGROUND Dobutamine stress echocardiography is widely used to test for ischemia in patients with stable coronary artery disease. In this analysis, we studied the ability of the prerandomization stress echocardiography score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina). METHODS One hundred eighty-three patients underwent dobutamine stress echocardiography before randomization. The stress echocardiography score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of prerandomization stress echocardiography to predict the placebo-controlled effect of PCI on response variables was tested by using regression modeling. RESULTS At prerandomization, the stress echocardiography score was 1.56±1.77 in the PCI arm (n=98) and 1.61±1.73 in the placebo arm (n=85). There was a detectable interaction between prerandomization stress echocardiography score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echocardiography score ( P interaction =0.031). With our sample size, we were unable to detect an interaction between stress echocardiography score and any other patient-reported response variables: freedom from angina ( P interaction =0.116), physical limitation ( P interaction =0.461), quality of life ( P interaction =0.689), EuroQOL 5 quality-of-life score ( P interaction =0.789), or between stress echocardiography score and physician-assessed Canadian Cardiovascular Society angina class ( P interaction =0.693), and treadmill exercise time ( P interaction =0.426). CONCLUSIONS The degree of ischemia assessed by dobutamine stress echocardiography predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echocardiography abnormality caused by a stenosis, the greater the reduction in symptoms from PCI. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02062593.",2019,,['Stable Coronary Artery Disease'],"['Placebo', 'Percutaneous Coronary Intervention', 'Dobutamine Stress Echocardiography Ischemia']",[],"[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0949700', 'cui_str': 'Echocardiography, Stress, Dobutamine'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",[],,0.158421,,"[{'ForeName': 'Rasha K', 'Initials': 'RK', 'LastName': 'Al-Lamee', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Shun-Shin', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Howard', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Nowbar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Rajkumar', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Sukhjinder', 'Initials': 'S', 'LastName': 'Nijjer', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keeble', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, UK (J.D., T.K., K.T.).'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Malik', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bual', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Yousif', 'Initials': 'Y', 'LastName': 'Ahmad', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Seligman', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Cardiff Royal Infirmary, UK (A.S.P.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerber', 'Affiliation': 'East Sussex Healthcare NHS Trust, Hastings, UK (R.G.).'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth and Christchurch NHS Trust, UK (S. Talwar).'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Assomull', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Cole', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Niall G', 'Initials': 'NG', 'LastName': 'Keenan', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Gajen', 'Initials': 'G', 'LastName': 'Kanaganayagam', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Joban', 'Initials': 'J', 'LastName': 'Sehmi', 'Affiliation': 'West Hertfordshire Hospitals NHS Trust, Watford, UK (N.G.K., J.S.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wensel', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Biostatistics, Nashville, TN (F.E.H.).'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Mayet', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., D.T., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., G.C., R.W., J.M., S. Thom, D.P.F.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042918'] 698,30668636,Comparison of Treadmill Trip-Like Training Versus Tai Chi to Improve Reactive Balance Among Independent Older Adult Residents of Senior Housing: A Pilot Controlled Trial.,"BACKGROUND There is growing interest in using perturbation-based balance training to improve the reactive response to common perturbations (eg, tripping and slipping). The goal of this study was to compare the efficacy of treadmill-based reactive balance training versus Tai Chi performed at, and among independent residents of, older adult senior housing. METHODS Thirty-five residents from five senior housing facilities were allocated to either treadmill-based reactive balance training or Tai Chi training. Both interventions were performed three times per week for 4 weeks, with each session lasting approximately 30 minutes. A battery of balance tests was performed at baseline, and again 1 week, 1 month, 3 months, and 6 months post-training. The battery included six standard clinical tests of balance and mobility, and a test of reactive balance performance. RESULTS At baseline, no significant between-group differences were found for any balance tests. After training, reactive balance training participants had better reactive balance than Tai Chi participants. Maximum trunk angle was 13.5° smaller among reactive balance training participants 1 week after training (p = .01), and a reactive balance rating was 24%-31% higher among reactive balance training participants 1 week to 6 months after training (p < .03). Clinical tests showed minimal differences between groups at any time point after training. CONCLUSION Trip-like reactive balance training performed at senior housing facilities resulted in better rapid balance responses compared with Tai Chi training.",2019,"Maximum trunk angle was 13.5 degrees smaller among reactive balance training participants one week after training (p = .01), and a reactive balance rating was 24-31% higher among reactive balance training participants one week to six months after training (p < .03).","['residents of, older adult senior housing', 'Methods\n\n\nThirty-five residents from five senior housing facilities', 'older adult residents of senior housing']","['treadmill-based reactive balance training or Tai Chi training', 'reactive balance training', 'treadmill trip-like training versus Tai Chi', 'treadmill-based reactive balance training versus Tai Chi']","['Maximum trunk angle', 'reactive balance rating', 'reactive balance', 'rapid balance responses']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0221188', 'cui_str': 'Tripping (event)'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",1.0,0.0243847,"Maximum trunk angle was 13.5 degrees smaller among reactive balance training participants one week after training (p = .01), and a reactive balance rating was 24-31% higher among reactive balance training participants one week to six months after training (p < .03).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aviles', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Leigh J', 'Initials': 'LJ', 'LastName': 'Allin', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Neil B', 'Initials': 'NB', 'LastName': 'Alexander', 'Affiliation': 'Division of Geriatric and Palliative Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Van Mullekom', 'Affiliation': 'Department of Statistics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Maury A', 'Initials': 'MA', 'LastName': 'Nussbaum', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Madigan', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz018'] 699,31221882,Different potencies of topical corticosteroids for a better treatment strategy in children with atopic dermatitis (the Rotterdam Eczema study): protocol for an observational cohort study with an embedded randomised open-label controlled trial.,"INTRODUCTION Topical corticosteroids (TCS) of different potencies are the main treatment to control atopic dermatitis (AD). The Dutch guideline on AD for general practitioners (GPs) recommends a stepwise approach in which treatment steps are tailored to the severity of the disease, starting with the lowest possible potency of TCS. However, it remains unclear whether the recommended stepwise approach is most efficient. This randomised open-label controlled trial aims to determine whether a potent TCS is more effective than a low-potency TCS in the initial treatment of children with a moderate flare-up of AD in primary care. In the observational cohort, the overall aim is to determine the frequency, burden and determinants of flare-ups of AD during follow-up. METHODS AND ANALYSIS The study is an observational cohort study with an embedded pragmatic randomised controlled, open-label trial. Eligible are patients diagnosed with AD (aged 12 weeks to 18 years) who visited the GP for AD or received repeated prescriptions for AD in the previous 12 months; follow-up of the cohort is 1 year. Children are enrolled in the trial if they have a flare-up of AD during follow-up in the cohort. Eligible children are randomised to the intervention group (with a potent TCS once daily) or to the GP guideline group (with a low potency TCS once daily). Primary outcome is the difference in average subjective disease severity over 24 weeks follow-up in the trial, measured with the patient-oriented eczema measure. As secondary outcome, the Eczema Area and Severity Index is measured. ETHICS AND DISSEMINATION This study tests the hypothesis that immediate treatment with a potent TCS during a flare-up of AD leads to faster and more efficacious results as compared with starting with a TCS with low potency with less overall use of TCS. The study protocol is approved by the Medical Ethics Committee (MEC) of the Erasmus Medical Center Rotterdam, the Netherlands (MEC-2017-328). The results of the study will be published in international peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER NTR: 6679; Pre-results.",2019,"The study protocol is approved by the Medical Ethics Committee (MEC) of the Erasmus Medical Center Rotterdam, the Netherlands (MEC-2017-328).","['children with atopic dermatitis (the Rotterdam Eczema study', 'Eligible children', 'children with a moderate flare-up of AD in primary care', 'Eligible are patients diagnosed with AD (aged 12\u2009weeks to 18\u2009years) who visited the GP for AD or received repeated prescriptions for AD in the previous 12\u2009months; follow-up of the cohort is 1\u2009year']","['potent TCS once daily) or to the GP guideline group (with a low potency TCS', 'TCS', 'topical corticosteroids', 'Topical corticosteroids (TCS']","['Eczema Area and Severity Index is measured', 'average subjective disease severity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0420263', 'cui_str': 'Repeated prescription'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.157872,"The study protocol is approved by the Medical Ethics Committee (MEC) of the Erasmus Medical Center Rotterdam, the Netherlands (MEC-2017-328).","[{'ForeName': 'Karlijn F', 'Initials': 'KF', 'LastName': 'van Halewijn', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Arthur M', 'Initials': 'AM', 'LastName': 'Bohnen', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'van den Berg', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Suzanne G M A', 'Initials': 'SGMA', 'LastName': 'Pasmans', 'Affiliation': 'Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Elshout', 'Affiliation': 'Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-027239'] 700,31221888,"Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold.","INTRODUCTION The common cold is the most common infectious disease affecting humans. It is usually a self-limiting disease; however, the common cold can cause significant morbidity and has a substantial economic impact on society. Human rhinoviruses (HRVs), which cause up to two-thirds of colds, have temperature-dependent replication and most HRV strains replicate optimally at 33°C. Delivery of heated, humidified air to the upper airways has the potential to reduce viral replication, but evidence of the effectiveness of this treatment of the common cold is inconclusive. We plan to test the hypothesis that delivery of humidified air heated to 41°C at high flow, nasal high flow rhinothermy (rNHF), for 2 hours daily for five days is more effective in reducing common cold symptom severity and duration than five days of 'sham' rhinothermy. METHODS AND ANALYSIS This is a randomised, single-blind, parallel-group trial comparing rNHF to 'sham' rhinothermy in the treatment of common cold. We plan to recruit 170 participants within 48 hours of the onset of symptoms of common cold and randomise them 1:1 to receive one of the two treatments for five days. The study duration is 14 days, which includes clinic visits on the first day of randomisation and four days post-randomisation, and a phone call on the 14th day. Participants will complete daily symptom diaries which include a symptom score, the Modified Jackson Score (MJS). The primary outcome is the MJS after four days. ETHICS AND DISSEMINATION New Zealand Ethics Registration: 17/STH/174. Results will be published in a peer-reviewed medical journal, presented at academic meetings, and reported to participants. TRIAL REGISTRATION NUMBER U1111-1194-4345 and ACTRN12617001340325; Pre-results.",2019,"This is a randomised, single-blind, parallel-group trial comparing rNHF to 'sham' rhinothermy in the treatment of common cold.",['170 participants within 48\u2009hours of the onset of symptoms of common cold and randomise them 1:1 to receive one of the two treatments for five\u2009days'],"['humidified air heated to 41°C at high flow, nasal high flow rhinothermy (rNHF', 'rhinothermy delivered by nasal high flow therapy', 'rNHF']","['complete daily symptom diaries which include a symptom score, the Modified Jackson Score (MJS', 'MJS after four\u2009days']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.4048,"This is a randomised, single-blind, parallel-group trial comparing rNHF to 'sham' rhinothermy in the treatment of common cold.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Bird', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Harper', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McKinstry', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Koorevaar', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Semprini', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Meik', 'Initials': 'M', 'LastName': 'Dilcher', 'Affiliation': 'Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Jennings', 'Affiliation': 'Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Department of Medicine, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2018-028098'] 701,31434605,E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT.,"BACKGROUND Over the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking. OBJECTIVE The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support. DESIGN A randomised controlled trial comparing e-cigarettes and NRT. SETTING Three sites that provide local SSSs. PARTICIPANTS The participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis. INTERVENTIONS The NRT arm ( n  = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm ( n  = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention. MAIN OUTCOME MEASURES The primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted. RESULTS The 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58; p  < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ 2  = 161.4; p  < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective. LIMITATIONS The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes. CONCLUSIONS Within the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy. FUTURE WORK The efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support. TRIAL REGISTRATION Current Controlled Trials ISRCTN60477608. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).",2019,Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status).,"['886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis', '886 smokers seeking help to quit smoking, aged ≥\u200918 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes', 'Participants lost to follow-up or not providing biochemical validation were included as non-abstainers', 'Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation']","['nicotine replacement therapy within the UK', 'refillable e-cigarettes and nicotine replacement therapy (NRT', 'NRT of their choice (single or combination', 'e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice', 'NRT']","['CO-validated sustained abstinence rates', 'abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health', 'adherence and experienced fewer urges to smoke', '1-year quit rate', 'coughing and phlegm', 'validated quit rates']","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C3661900', 'cui_str': 'Not provided (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus (substance)'}]",886.0,0.0854514,Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""King's Clinical Trials Unit, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Katie Myers', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bisal', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""King's Clinical Trials Unit, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Leicester City Council, Leicester, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Goniewicz', 'Affiliation': 'Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Hayden J', 'Initials': 'HJ', 'LastName': 'McRobbie', 'Affiliation': 'Health and Lifestyle Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23430'] 702,31129065,"Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial.","BACKGROUND Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy. METHODS RESTART was a prospective, randomised, open-label, blinded-endpoint, parallel-group trial at 122 hospitals in the UK that assessed whether starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. For this prespecified subgroup analysis, consultant neuroradiologists masked to treatment allocation reviewed brain CT or MRI scans performed before randomisation to confirm participant eligibility and rate features of the intracerebral haemorrhage and surrounding brain. We followed participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere). For this report, we analysed eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI. The trial is registered with the ISRCTN registry, number ISRCTN71907627. FINDINGS Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required brain MRI protocol (122 in the start antiplatelet therapy group and 132 in the avoid antiplatelet therapy group). There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence (0 or 1) (adjusted hazard ratio [HR] 0·30 [95% CI 0·08-1·13] vs 0·77 [0·13-4·61]; p interaction =0·41), cerebral microbleed number 0-1 versus 2-4 versus 5 or more (HR 0·77 [0·13-4·62] vs 0·32 [0·03-3·66] vs 0·33 [0·07-1·60]; p interaction =0·75), or cerebral microbleed strictly lobar versus other location (HR 0·52 [0·004-6·79] vs 0·37 [0·09-1·28]; p interaction =0·85). There was no evidence of heterogeneity in the effects of antiplatelet therapy in any exploratory subgroup analyses (all p interaction >0·05). INTERPRETATION Our findings exclude all but a very modest harmful effect of antiplatelet therapy on recurrent intracerebral haemorrhage in the presence of cerebral microbleeds. Further randomised trials are needed to replicate these findings and investigate them with greater precision. FUNDING British Heart Foundation.",2019,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"['Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required', 'eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI', 'intracerebral haemorrhage and cerebral small vessel diseases', '0·13-4·62', 'participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere', '0·004-6·79']","['antiplatelet therapy', 'cerebral microbleed strictly lobar versus other location (HR 0·52', 'brain MRI protocol']","['recurrent intracerebral haemorrhage', 'stroke risk', 'risk of recurrent symptomatic intracerebral haemorrhage']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2733158', 'cui_str': 'Cerebral Microangiopathies'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",537.0,0.211384,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"[{'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. Electronic address: rustam.al-shahi@ed.ac.uk.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Minks', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Dipayan', 'Initials': 'D', 'LastName': 'Mitra', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Rodrigues', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Johann C', 'Initials': 'JC', 'LastName': 'du Plessis', 'Affiliation': 'Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Yogish', 'Initials': 'Y', 'LastName': 'Joshi', 'Affiliation': ""Department of Radiology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter A G', 'Initials': 'PAG', 'LastName': 'Sandercock', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neurosciences, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cathie L M', 'Initials': 'CLM', 'LastName': 'Sudlow', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Group, Department of Brain Repair and Rehabilitation, University College London Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; UK Dementia Research Institute at the University of Edinburgh, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'White', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30184-X'] 703,31129587,Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury-PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial.,"INTRODUCTION S100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI). Sampling should take place within 3 hours of trauma and cut-off levels should be based on paediatric reference ranges. The aim of this study is to evaluate the utility of measuring serum S100B in the management of paediatric mTBI by demonstrating a decrease in the number of CCT scans prescribed in an S100B biomonitoring group compared with a 'conventional management' control group, with the assumption of a 30% relative decrease of the number of CCT scans between the two groups. METHODS AND ANALYSIS The protocol is a randomised, multicentre, unblinded, prospective, interventional study (nine centres) using a stepped wedge cluster design, comparing two groups (S100B biomonitoring and control). Children in the control group will have CCT scans or be hospitalised according to the current recommendations of the French Society of Paediatrics (SFP). In the S100B biomonitoring group, blood sampling to determine serum S100B protein levels will take place within 3 hours after mTBI and subsequent management will depend on the assay. If S100B is in the normal range according to age, the children will be discharged from the emergency department after 6 hours' observation. If the result is abnormal, CCT scans or hospitalisation will be prescribed in accordance with current SFP recommendations. The primary outcome measure will be the proportion of CCT scans performed (absence/presence of CCT scan for each patient) in the 48 hours following mTBI. ETHICS AND DISSEMINATION The protocol presented (Version 5, 03 November 2017) has been approved by the ethics committee Comité de Protection des Personnes sud-est 6 (first approval 08 June 2016, IRB: 00008526). Participation in the study is voluntary and anonymous. The study findings will be disseminated in international peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER NCT02819778.",2019,"INTRODUCTION S100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI).","['paediatric mild traumatic brain injury-PROS100B', 'children with mild traumatic brain injury (mTBI']",['serum S100B protein biomonitoring'],"['number of cranial CT (CCT) scans', 'proportion of CCT scans performed (absence/presence of CCT scan for each patient', 'number of CCT scans']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005517', 'cui_str': 'Biological Monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0441633'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.136766,"INTRODUCTION S100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI).","[{'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bouvier', 'Affiliation': 'Biochemistry and Molecular Genetic Department, CHU Clermont-Ferrand, Université Clermont Auvergne, CNRS, INSERM, GReD, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balayssac', 'Affiliation': 'DRCI, CHU Clermont-Ferrand, Université Clermont-Auvergne, INSERM U1107, NEURO-DOL, Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Durif', 'Affiliation': 'Biochemistry and Molecular Genetic Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Mourgues', 'Affiliation': 'DRCI, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sarret', 'Affiliation': 'Pediatric Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'DRCI, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Sapin', 'Affiliation': 'Biochemistry and Molecular Genetic Department, CHU Clermont-Ferrand, Université Clermont Auvergne, CNRS, INSERM, GReD, Clermont-Ferrand, France.'}]",BMJ open,['10.1136/bmjopen-2018-027365'] 704,31005674,Moderators of two dual eating disorder and obesity prevention programs.,"Few trials have investigated factors that moderate the effects of eating disorder and obesity prevention programs, which may inform inclusion criteria and intervention refinements. We examined factors hypothesized to moderate the effects of the Healthy Weight eating disorder/obesity prevention program that promotes gradual healthy changes, and Project Health that adds cognitive dissonance activities. College students at risk for both outcomes because of weight concerns (N = 364, 72% female) were randomized to these interventions or an educational video condition, completing pretest, posttest, and 6, 12, and 24-month follow-up assessments. Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin. Project Health also produced significantly less increases in BMI versus video controls for individuals with lower negative affect. Results suggest that these interventions produce larger eating disorder symptom reductions for individuals at elevated risk for eating pathology but hint that weight gain prevention effects may be attenuated by elevated negative affect. Results imply that larger eating disorder symptom reductions will result when implemented with individuals with both weight concerns and one of the additionally identified risk factors.",2019,"Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin.","['College students at risk for both outcomes because of weight concerns (N\u202f=\u202f364, 72% female']",[],"['larger eating disorder symptom reductions', 'eating disorder symptoms', 'BMI', 'eating disorder symptom reductions']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.017318,"Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA. Electronic address: estice@ori.org.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Desjardins', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Shaw', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.04.002'] 705,31076561,Metformin induces a fasting- and antifolate-mimicking modification of systemic host metabolism in breast cancer patients.,"Certain dietary interventions might improve the therapeutic index of cancer treatments. An alternative to the ""drug plus diet"" approach is the pharmacological reproduction of the metabolic traits of such diets. Here we explored the impact of adding metformin to an established therapeutic regimen on the systemic host metabolism of cancer patients. A panel of 11 serum metabolites including markers of mitochondrial function and intermediates/products of folate-dependent one-carbon metabolism were measured in paired baseline and post-treatment sera obtained from HER2-positive breast cancer patients randomized to receive either metformin combined with neoadjuvant chemotherapy and trastuzumab or an equivalent regimen without metformin. Metabolite profiles revealed a significant increase of the ketone body β-hydroxybutyrate and of the TCA intermediate α-ketoglutarate in the metformin-containing arm. A significant relationship was found between the follow-up levels of homocysteine and the ability of treatment arms to achieve a pathological complete response (pCR). In the metformin-containing arm, patients with significant elevations of homocysteine tended to have a higher probability of pCR. The addition of metformin to an established anti-cancer therapeutic regimen causes a fasting-mimicking modification of systemic host metabolism. Circulating homocysteine could be explored as a clinical pharmacodynamic biomarker linking the antifolate-like activity of metformin and biological tumor response.",2019,A significant relationship was found between the follow-up levels of homocysteine and the ability of treatment arms to achieve a pathological complete response (pCR).,"['breast cancer patients', 'cancer patients']","['metformin combined with neoadjuvant chemotherapy and trastuzumab or an equivalent regimen without metformin', 'Metformin', 'Certain dietary interventions', 'metformin']","['ketone body β-hydroxybutyrate and of the TCA intermediate α-ketoglutarate', 'pathological complete response (pCR']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}]","[{'cui': 'C0202110', 'cui_str': 'Ketone bodies measurement, quantitative (procedure)'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",,0.0294636,A significant relationship was found between the follow-up levels of homocysteine and the ability of treatment arms to achieve a pathological complete response (pCR).,"[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Cuyàs', 'Affiliation': 'Program Against Cancer Therapeutic Resistance (ProCURE), Metabolism and Cancer Group, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Fernández-Arroyo', 'Affiliation': 'Unitat de Recerca Biomèdica, Hospital Universitari de Sant Joan, IISPV, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buxó', 'Affiliation': 'Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': ""Department of Medical Oncology, Breast Unit, Catalan Institute of Oncology-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Dorca', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Álvarez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Donostia, Donostia-San Sebastián, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Martínez', 'Affiliation': 'Medical Oncology Department, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Garcia', 'Affiliation': 'IOB Institute of Oncology, Hospital Quirónsalud, Madrid and Barcelona, Spain.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Batista-López', 'Affiliation': 'Medical Oncology Service, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain.'}, {'ForeName': 'César A', 'Initials': 'CA', 'LastName': 'Rodríguez-Sánchez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Kepa', 'Initials': 'K', 'LastName': 'Amillano', 'Affiliation': 'Medical Oncology, Hospital Universitari Sant Joan, Reus, Spain.'}, {'ForeName': 'Severina', 'Initials': 'S', 'LastName': 'Domínguez', 'Affiliation': 'Medical Oncology Service, Hospital Universitario Araba, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Luque', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Morilla', 'Affiliation': ""Department of Medical Oncology, Breast Unit, Catalan Institute of Oncology-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Agostina', 'Initials': 'A', 'LastName': 'Stradella', 'Affiliation': ""Department of Medical Oncology, Breast Unit, Catalan Institute of Oncology-Hospital Universitari de Bellvitge-Bellvitge Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Viñas', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Hospital Quirónsalud, Madrid and Barcelona, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Verdura', 'Affiliation': 'Program Against Cancer Therapeutic Resistance (ProCURE), Metabolism and Cancer Group, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Eugeni', 'Initials': 'E', 'LastName': 'López-Bonet', 'Affiliation': 'Department of Anatomical Pathology, Dr. Josep Trueta Hospital of Girona, Girona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': ""Clinical Research Unit, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Samiha', 'Initials': 'S', 'LastName': 'Saidani', 'Affiliation': 'Unit of Clinical Research, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Joven', 'Affiliation': 'Unitat de Recerca Biomèdica, Hospital Universitari de Sant Joan, IISPV, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Martin-Castillo', 'Affiliation': 'Unit of Clinical Research, Catalan Institute of Oncology, Girona, Spain.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Menendez', 'Affiliation': 'Program Against Cancer Therapeutic Resistance (ProCURE), Metabolism and Cancer Group, Catalan Institute of Oncology, Girona, Spain.'}]",Aging,['10.18632/aging.101960'] 706,31570566,"Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate.","PURPOSE Selective progesterone receptor modulators (SPRMs) show preclinical activity against hormone-sensitive breast cancer, but have not been tested in patients with early, treatment-naïve tumors. PATIENTS AND METHODS In a double-blind presurgical window trial of oral telapristone acetate (TPA) 12 mg daily versus placebo, 70 patients with early-stage breast cancer were randomized 1:1 (stratified by menopause) and treated for 2 to 10 weeks. The primary endpoint was change in Ki67 between diagnostic biopsy and surgical specimens. Gene expression pre- and posttherapy was assessed using RNA-sequencing and gene set enrichment analysis was performed to determine pathways enriched in response to TPA and placebo treatments. RESULTS Among 61 evaluable women (29 placebo and 32 telapristone acetate), 91% of tumors were ER/PR positive. The mean Ki67 declined by 5.5% in all women treated with telapristone acetate ( P = 0.003), and by 4.2% in all women treated with placebo ( P = 0.04). After menopausal stratification, the Ki67 decline remained significant in 22 telapristone acetate-treated premenopausal women ( P = 0.03). Differential gene expression analysis showed no significant modulation overall. However, in a subset of tumors that demonstrated ≥30% relative reduction in Ki67 in the telapristone acetate group, genes related to cell-cycle progression, and those in the HER2 amplicon were significantly downregulated. In contrast, no significantly enriched pathways were identified in the placebo group. CONCLUSIONS Patients treated with telapristone acetate whose Ki67 decreased by ≥30% demonstrated a selective antiproliferative signal, with a potentially important effect on HER2 amplicon genes. Evaluation of SPRMs in a neoadjuvant trial is merited, with attention to predictors of response to SPRM therapy, and inclusion of pre- and postmenopausal women.",2020,"The mean Ki67 declined by 5.5% in all TPA-treated women (p= 0.003), and by 4.2% in all placebo-treated women (p=0.04).","['early stage breast cancer', 'patients with early, treatment-naïve tumors', '70 early stage breast cancer patients']","['progesterone receptor modulators (SPRMs', 'placebo', 'oral telapristone acetate (TPA', 'Selective progesterone receptor modulators', 'telapristone acetate']","['change in Ki67 between diagnostic biopsy and surgical specimens', 'HER2 amplicon', 'mean Ki67']","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3501648', 'cui_str': 'telapristone acetate'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.25022,"The mean Ki67 declined by 5.5% in all TPA-treated women (p= 0.003), and by 4.2% in all placebo-treated women (p=0.04).","[{'ForeName': 'Oukseub', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pathology of NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Muzzio', 'Affiliation': 'Illinois Institute of Technology Research Institute, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Helenowski', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shidfar', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Zexian', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Singhal', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Borko', 'Initials': 'B', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Bethke', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Department of Surgery Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'J Julie', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Clare', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0443'] 707,30789018,Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease.,"Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy. Subjects demonstrating correct placebo inhaler use within three attempts at screening were instructed to take once-daily inhalations from the inhaler for 28 ± 2 days (continuing usual maintenance), followed by randomization to complete one of two versions of an ease-of-use questionnaire and reassessment for correct inhaler use. At study end, 96% asthma/93% COPD subjects rated the placebo inhaler as ""easy"" or ""very easy"" to use while demonstrating correct use. Furthermore, 99% asthma/99% COPD subjects indicated it was ""easy"" or ""very easy"" to determine number of doses remaining, and 81%/84%, respectively, indicated they would be ""likely"" or ""very likely"" to request their current medication in the inhaler, if available. Adverse event (AE) rates were 12% asthma/15% COPD, most frequently headache (3%/3%). Treatment-related AEs were reported in one subject with asthma (cough) and four subjects with COPD (cough, n = 3; back pain, n = 1). At study end, most subjects with asthma or COPD operated the placebo inhaler correctly and found it easy to use.",2019,"Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy.","['adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy', 'subjects with asthma or COPD operated the', 'subjects with asthma and chronic obstructive pulmonary disease']","['placebo dry powder inhaler', 'placebo']",['Adverse event (AE) rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853847', 'cui_str': 'Dry Powder Inhaler'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",278.0,0.0754454,"Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy.","[{'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Feldman', 'Affiliation': '1 S. Carolina Pharmaceutical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Dmitry V', 'Initials': 'DV', 'LastName': 'Galkin', 'Affiliation': '2 Respiratory Medical Franchise, GlaxoSmithKline, Durham, NC, USA.'}, {'ForeName': 'Pinal', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': '3 Respiratory Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Collison', 'Affiliation': '2 Respiratory Medical Franchise, GlaxoSmithKline, Durham, NC, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': '4 Respiratory Medical Franchise, GlaxoSmithKline, Brentford, UK.'}]",Chronic respiratory disease,['10.1177/1479973118815692'] 708,31950979,"Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial.","Importance It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock. Objective To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock. Design, Setting, and Participants Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019. Interventions Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days. Main Outcomes and Measures The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality. Results Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported. Conclusions and Relevance In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone. Trial Registration ClinicalTrials.gov Identifier: NCT03333278.",2020,"No serious adverse events were reported. ","['Patients With Septic Shock', '216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63', '10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock', 'The first patient was enrolled on May 8, 2018, and the last on July 9, 2019', 'patients with septic shock']","['intravenous vitamin C, hydrocortisone, and thiamine', 'intravenous hydrocortisone', 'hydrocortisone alone', 'vitamin C, hydrocortisone, and thiamine', 'intravenous vitamin C', 'thiamine', 'hydrocortisone', 'Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone']","['Time alive and vasopressor free', 'Ninety-day mortality', 'duration of time alive and free of vasopressor administration up to day 7', 'serious adverse events', 'duration of time alive and free of vasopressor administration', 'Time Alive and Free of Vasopressor Support', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",216.0,0.416565,"No serious adverse events were reported. ","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Frei', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Edney', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hunt', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Judd', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Forbes', 'Initials': 'F', 'LastName': 'McGain', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Hudson', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dhiraj Bhatia', 'Initials': 'DB', 'LastName': 'Dwivedi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Peppin', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Orosz', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22176'] 709,31145699,A randomized 3-way crossover study indicates that high-protein feeding induces de novo lipogenesis in healthy humans.,"BACKGROUNDDietary changes have led to the growing prevalence of type 2 diabetes and nonalcoholic fatty liver disease. A hallmark of both disorders is hepatic lipid accumulation, derived in part from increased de novo lipogenesis. Despite the popularity of high-protein diets for weight loss, the effect of dietary protein on de novo lipogenesis is poorly studied. We aimed to characterize the effect of dietary protein on de novo lipid synthesis.METHODSWe use a 3-way crossover interventional study in healthy males to determine the effect of high-protein feeding on de novo lipogenesis, combined with in vitro models to determine the lipogenic effects of specific amino acids. The primary outcome was a change in de novo lipogenesis-associated triglycerides in response to protein feeding.RESULTSWe demonstrate that high-protein feeding, rich in glutamate, increases de novo lipogenesis-associated triglycerides in plasma (1.5-fold compared with control; P < 0.0001) and liver-derived very low-density lipoprotein particles (1.8-fold; P < 0.0001) in samples from human subjects (n = 9 per group). In hepatocytes, we show that glutamate-derived carbon is incorporated into triglycerides via palmitate. In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake. Glutamate, glutamine, and leucine increased activation of protein kinase B, suggesting that induction of de novo lipogenesis occurs via the insulin signaling cascade.CONCLUSIONThese findings provide mechanistic insight into how select amino acids induce de novo lipogenesis and insulin resistance, suggesting that high-protein feeding to tackle diabetes and obesity requires greater consideration.FUNDINGThe research was supported by UK Medical Research Council grants MR/P011705/1, MC_UP_A090_1006 and MR/P01836X/1. JLG is supported by the Imperial Biomedical Research Centre, National Institute for Health Research (NIHR).",2019,"In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake.","['healthy humans', 'healthy males']","['JLG', 'dietary protein']","['de novo lipogenesis-associated triglycerides in plasma', 'triglyceride synthesis and decreased glucose uptake', 'change in de novo lipogenesis-associated triglycerides in response to protein feeding']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}]","[{'cui': 'C1563744', 'cui_str': 'Lipogenesis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.0212108,"In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake.","[{'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Charidemou', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Ashmore', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ben D', 'Initials': 'BD', 'LastName': 'McNally', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'West', 'Affiliation': ""Division of Gastroenterology and Hepatology, Department of Medicine, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Liggi', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Harvey', 'Affiliation': 'Medical Research Council - Elsie Widdowson Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Orford', 'Affiliation': 'Medical Research Council - Elsie Widdowson Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Julian L', 'Initials': 'JL', 'LastName': 'Griffin', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}]",JCI insight,['10.1172/jci.insight.124819'] 710,30555154,A randomized controlled laboratory study on the long-term effects of methylphenidate on cardiovascular function and structure in rhesus monkeys.,"BACKGROUND Whether long-term methylphenidate (MPH) results in any changes in cardiovascular function or structure can only be properly addressed through a randomized trial using an animal model which permits elevated dosing over an extended period of time. METHODS We studied 28 male rhesus monkeys (Macaca mulatta) approximately 7 years of age that had been randomly assigned to one of three MPH dosages: vehicle control (0 mg/kg, b.i.d., n = 9), low dose (2.5 mg/kg, b.i.d., n = 9), or high dose (12.5 mg/kg, b.i.d., n = 10). Dosage groups were compared on serum cardiovascular and inflammatory biomarkers, electrocardiograms (ECGs), echocardiograms, myocardial biopsies, and clinical pathology parameters following 5 years of uninterrupted dosing. RESULTS With the exception of serum myoglobin, there were no statistical differences or apparent dose-response trends in clinical pathology, cardiac inflammatory biomarkers, ECGs, echocardiograms, or myocardial biopsies. The high-dose MPH group had a lower serum myoglobin concentration (979 ng/mL) than either the low-dose group (1882 ng/mL) or the control group (2182 ng/mL). The dose response was inversely proportional to dosage (P = .0006). CONCLUSIONS Although the findings cannot be directly generalized to humans, chronic MPH exposure is unlikely to be associated with increased cardiovascular risk in healthy children.",2019,"With the exception of serum myoglobin, there were no statistical differences or apparent dose-response trends in clinical pathology, cardiac inflammatory biomarkers, ECGs, echocardiograms, or myocardial biopsies.","['healthy children', 'rhesus monkeys', 'Macaca mulatta) approximately 7 years of age that had been randomly assigned to one of three', '28 male rhesus monkeys ']","['methylphenidate (MPH', 'methylphenidate', 'MPH dosages: vehicle control']","['cardiovascular function and structure', 'serum cardiovascular and inflammatory biomarkers, electrocardiograms (ECGs), echocardiograms, myocardial biopsies, and clinical pathology parameters', 'clinical pathology, cardiac inflammatory biomarkers, ECGs, echocardiograms, or myocardial biopsies', 'serum myoglobin concentration', 'cardiovascular risk']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0024400', 'cui_str': 'Rhesus Macaque'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0026447', 'cui_str': 'Monkeys'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1304881', 'cui_str': 'Myocardial biopsy'}, {'cui': 'C0030667', 'cui_str': 'Pathology, Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",28.0,0.175815,"With the exception of serum myoglobin, there were no statistical differences or apparent dose-response trends in clinical pathology, cardiac inflammatory biomarkers, ECGs, echocardiograms, or myocardial biopsies.","[{'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Callicott', 'Affiliation': 'Animal Resource Center, University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Salminen', 'Affiliation': 'Toxicology and Formulations, Pro Natural Brands, LLC, Victor, NY, 14564, USA.'}, {'ForeName': 'Satinder K', 'Initials': 'SK', 'LastName': 'Sandhu', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, 33156, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Greenhaw', 'Affiliation': 'Division of Systems Biology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Paredes', 'Affiliation': 'Office of Scientific Coordination, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Toxicologic Pathology Associates, Jefferson, AR, 72079, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jones', 'Affiliation': 'Office of Scientific Coordination, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.'}, {'ForeName': 'Merle G', 'Initials': 'MG', 'LastName': 'Paule', 'Affiliation': 'Division of Neurotoxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Slikker', 'Affiliation': 'Office of the Center Director, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.'}, {'ForeName': 'Paolo G', 'Initials': 'PG', 'LastName': 'Rusconi', 'Affiliation': 'Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, 33156, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Czachor', 'Affiliation': ""Department of Pediatrics, Wayne State University School of Medicine and Children's Hospital of Michigan, Detroit, MI, 48201, USA.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bodien', 'Affiliation': ""Department of Pediatrics, Wayne State University School of Medicine and Children's Hospital of Michigan, Detroit, MI, 48201, USA.""}, {'ForeName': 'Joslyn A', 'Initials': 'JA', 'LastName': 'Westphal', 'Affiliation': ""Department of Pediatrics, Wayne State University School of Medicine and Children's Hospital of Michigan, Detroit, MI, 48201, USA.""}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Dauphin', 'Affiliation': 'Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, 33156, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Lipshultz', 'Affiliation': ""Department of Pediatrics, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Oishei Children's Hospital, Roswell Park Comprehensive Cancer Center, Buffalo, NY, 14203, USA. slipshultz@upa.chob.edu.""}]",Pediatric research,['10.1038/s41390-018-0256-9'] 711,31129603,"Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol.","INTRODUCTION Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking. METHODS AND ANALYSIS: Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18-70 years. Interventions : (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition , (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. Flavour : blond tobacco. (C) Reference : ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorisationauthorisation. Treatment duration : 1 week+3 months. Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9-12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. Secondary outcomes : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline. ETHICS AND DISSEMINATION The ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions. TRIAL REGISTRATION NUMBER NCT03630614; Pre-results.",2019,"Secondary outcomes : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline. ETHICS AND DISSEMINATION ","['Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18-70 years']","['Varenicline', 'nicotine', 'ECwoN plus 0.5\u2009mg varenicline', 'placebo', 'nicotine (ECwoN) plus placebo tablets of varenicline', 'nicotine (ECwN) plus placebo tablets of varenicline', 'electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine']","['self-report of no smoking during the previous 2 weeks and expired air carbon monoxide', 'continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes', 'safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0002743', 'cui_str': 'Neonicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",,0.791421,"Secondary outcomes : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline. ETHICS AND DISSEMINATION ","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Berlin', 'Affiliation': 'Département de pharmacologie, Hôpital Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dautzenberg', 'Affiliation': 'Département de pharmacologie, Hôpital Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Lehmann', 'Affiliation': 'Agence générale des équipements et produits de santé, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Palmyre', 'Affiliation': 'Unité de Recherche Clinique, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Liégey', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, Assistance publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'De Rycke', 'Affiliation': 'Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), INSERM, AP-HP, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': 'Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), INSERM, AP-HP, Hôpital Pitié-Salpêtrière, Paris, France.'}]",BMJ open,['10.1136/bmjopen-2018-028832'] 712,31167867,"Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia.","INTRODUCTION Smoke-free policies have been introduced in prisons internationally. However, high rates of relapse to smoking after release from prison indicate that these policies typically result in short-term smoking cessation only. These high rates of relapse, combined with a lack of investment in relapse prevention, highlight a missed opportunity to improve the health of a population who smoke tobacco at two to six times the rate of the general population. This paper describes the rationale and design of a randomised controlled trial, testing the effectiveness of a caseworker-delivered intervention promoting smoking cessation among former smokers released from smoke-free prisons in Victoria, Australia. METHODS AND ANALYSIS The multicomponent, brief intervention consists of behavioural counselling, provision of nicotine spray and referral to Quitline and primary care to promote use of government-subsidised smoking cessation pharmacotherapy. The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison. Control group participants will receive usual care. Smoking abstinence will be assessed at 1 and 3 months postrelease, and confirmed with carbon monoxide breath testing. Linkage of participant records to survey and routinely collected administrative data will provide further information on postrelease use of health services and prescribed medication. ETHICS AND DISSEMINATION Ethical approval has been obtained from the Corrections Victoria Research Committee, the Victorian Department of Justice Human Research Ethics Committee, the Department of Human Services External Request Evaluation Committee and the University of Melbourne Human Research Ethics Committee. Results will be submitted to major international health-focused journals. In case of success, findings will assist policymakers to implement urgently needed interventions promoting the maintenance of prison-initiated smoking abstinence after release, to reduce the health disparities experienced by this marginalised population. TRIAL REGISTRATION NUMBER ACTRN12618000072213; Pre-results.",2019,The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison.,"['smoking abstinence after release from smoke-free prisons in Victoria, Australia', 'former smokers released from smoke-free prisons in Victoria, Australia']","['caseworker-delivered intervention promoting smoking cessation', 'nicotine spray and referral to Quitline and primary care to promote use of government-subsidised smoking cessation pharmacotherapy', 'multicomponent intervention', 'usual care']","['Staying Quit', 'Smoking abstinence']","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.070323,The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison.,"[{'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Young', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cheneal', 'Initials': 'C', 'LastName': 'Puljević', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Love', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Emilia K', 'Initials': 'EK', 'LastName': 'Janca', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Segan', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Donita', 'Initials': 'D', 'LastName': 'Baird', 'Affiliation': 'Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Whiffen', 'Affiliation': 'Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Pappos', 'Affiliation': 'Australian Community Support Organisation, Richmond, Victoria, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bell', 'Affiliation': 'Australian Community Support Organisation, Richmond, Victoria, Australia.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Kinner', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-027307'] 713,30948516,Five-year costs from a randomised comparison of bilateral and single internal thoracic artery grafts.,"BACKGROUND The use of bilateral internal thoracic arteries (BITA) for coronary artery bypass grafting (CABG) may improve survival compared with CABG using single internal thoracic arteries (SITA). We assessed the long-term costs of BITA compared with SITA. METHODS Between June 2004 and December 2007, 3102 patients from 28 hospitals in seven countries were randomised to CABG surgery using BITA (n=1548) or SITA (n=1554). Detailed resource use data were collected from the initial hospital episode and annually up to 5 years. The associated costs of this resource use were assessed from a UK perspective with 5 year totals calculated for each trial arm and pre-selected patient subgroups. RESULTS Total costs increased by approximately £1000 annually in each arm, with no significant annual difference between trial arms. Cumulative costs per patient at 5-year follow-up remained significantly higher in the BITA group (£18 629) compared with the SITA group (£17 480; mean cost difference £1149, 95% CI £330 to £1968, p=0.006) due to the higher costs of the initial procedure. There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events. CONCLUSIONS Higher index costs for BITA were still present at 5-year follow-up mainly driven by the higher initial cost with no subsequent difference emerging between 1 year and 5 years of follow-up. The overall cost-effectiveness of the two procedures, to be assessed at the primary endpoint of the 10-year follow-up, will depend on composite differences in costs and quality-adjusted survival. TRIAL REGISTRATION NUMBER ISRCTN46552265.",2019,"There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events. ","['n=1548) or SITA (n=1554', 'Between June 2004 and December 2007, 3102 patients from 28 hospitals in seven countries']","['CABG surgery using BITA', 'bilateral and single internal thoracic artery grafts', 'coronary artery bypass grafting (CABG', 'bilateral internal thoracic arteries (BITA']","['Total costs', 'cost associated with healthcare contacts, medication use or serious adverse events', 'Cumulative costs', 'costs and quality-adjusted survival', 'overall cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0226276', 'cui_str': 'Internal Mammary Artery'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",3102.0,0.2024,"There were no significant differences between the trial arms in the cost associated with healthcare contacts, medication use or serious adverse events. ","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Altman', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'University of Bristol School of Clinical Science, Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gerry', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, Oxford, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford Health Economics Research Centre, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taggart', 'Affiliation': 'Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-313932'] 714,31888938,Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol.,"INTRODUCTION Type 2 diabetes is common, affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have developed messages aiming to support patients' self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the intervention, compared with usual care. METHODS AND ANALYSIS The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6 months. The aims are to test recruitment methods, retention to the study, the feasibility of data collection and the mobile phone and web-based processes of a proposed definitive trial and to refine the text messaging intervention. The primary outcome is the rate of recruitment to randomisation of participants to the trial. Data, including patient reported measures, will be collected online at baseline and the end of the 6-month follow-up period. With 200 participants (100 in each group), this trial is powered to estimate 80% follow-up within 95% CIs of 73.8% to 85.3%. The analysis will follow a prespecified plan. ETHICS AND DISSEMINATION Ethics approval was obtained from the West of Scotland Research Ethics Committee 05. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: www.summit-d.org (SuMMiT-D (SUpport through Mobile Messaging and digital health Technology for Diabetes)). TRIAL REGISTRATION NUMBER ISRCTN13404264.",2019,"The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England.","['primary care recruiting adults (≥35 years) with type 2 diabetes in England', 'Consenting participants']",['short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6\u2009months'],"['rate of recruitment to randomisation', 'effectiveness and cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",200.0,0.243696,"The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK andrew.farmer@phc.ox.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'Bartlett', 'Affiliation': 'The Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'French', 'Affiliation': 'The Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gudgin', 'Affiliation': 'Patient Representative, Oxford, UK.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'UCL School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Kenning', 'Affiliation': 'Institute of Population Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Locock', 'Affiliation': 'Health Service Research, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McSharry', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': 'Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Newhouse', 'Affiliation': ''}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Rea', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033504'] 715,31182448,"Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup.","INTRODUCTION Most patients (>70%) experience acute neuropathic symptoms shortly after oxaliplatin infusions. These symptoms are not always resolved between infusions. Overall, 30%-50% of patients suffer from chronic oxaliplatin-induced peripheral neuropathy (OIPN). This cumulative and dose-dependent sensory neuropathy limits compliance or results in oxaliplatin-based chemotherapies to be substituted with less neurotoxic agents. These treatment changes impair clinical outcomes, and may be associated with comorbidities, such as distress, depression and anxiety. Currently, no drug used to prevent or treat OIPN is sufficiently effective to be used routinely in clinical practice. There is, thus, an unmet therapeutic need to reduce the intensity of and/or prevent OIPN. We hypothesised that riluzole would be an excellent candidate to address this public health issue. Riluzole is approved for treating amyotrophic lateral sclerosis. In animals, there is a beneficial effect on sensorimotor and pain disorders, as well as related comorbidities, after repeated administration of oxaliplatin. In humans, riluzole has shown neuroprotective, anxiolytic and antidepressive effects. METHODS AND ANALYSIS RILUZOX-01 trial was designed as a randomised, controlled, double-blind study to evaluate the efficacy of riluzole to prevent OIPN. Patients with colorectal cancer and initiating adjuvant oxaliplatin-based chemotherapy are eligible. Patients (n=210) will be randomly assigned to either riluzole or placebo, concomitantly with chemotherapy. The primary endpoint is the change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20, after six 2-week cycles of chemotherapy. Secondary endpoints include incidence and severity of neuropathy, grade of sensory neuropathy, intensity and features of neuropathic pain, health-related quality of life, disease-free survival, overall survival and safety. ETHICS AND DESSIMINATION The study was approved by a French ethics committee (ref:39/18_1, 'Comité de Protection des Personnes' Ouest-IV, France) and plans to start enroling patients in September 2019. The trial is registered in EudraCT and clinicaltrials.gov. TRIAL REGISTRATION NUMBER N°2017-002320-25; NCT03722680.",2019,"The primary endpoint is the change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20, after six 2-week cycles of chemotherapy.","['Patients with colorectal cancer and initiating adjuvant', 'Patients (n=210']","['riluzole or placebo, concomitantly with chemotherapy', 'Riluzole', 'oxaliplatin infusions', 'oxaliplatin-based chemotherapy', 'oxaliplatin', 'oxaliplatin-based chemotherapies', 'riluzole']","['acute neuropathic symptoms', 'incidence and severity of neuropathy, grade of sensory neuropathy, intensity and features of neuropathic pain, health-related quality of life, disease-free survival, overall survival and safety', 'change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20', 'peripheral neuropathy (OIPN', 'sensorimotor and pain disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}]",,0.614868,"The primary endpoint is the change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20, after six 2-week cycles of chemotherapy.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Kerckhove', 'Affiliation': 'Medical pharmacology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'Busserolles', 'Affiliation': 'INSERM 1107, NEURO-DOL Basic and Clinical Pharmacology of Pain, University Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stanbury', 'Affiliation': 'Supportive Care Group, UNICANCER, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'DRCI, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Plence', 'Affiliation': 'Supportive Care Group, UNICANCER, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'INSERM 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Krakowski', 'Affiliation': 'Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Eschalier', 'Affiliation': 'Institut Analgesia, Faculty of medicine, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'INSERM 1107, NEURO-DOL Basic and Clinical Pharmacology of Pain, University Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balayssac', 'Affiliation': 'INSERM 1107, NEURO-DOL Basic and Clinical Pharmacology of Pain, University Clermont Auvergne, Clermont-Ferrand, France.'}]",BMJ open,['10.1136/bmjopen-2018-027770'] 716,31201191,Does a novel diagnostic pathway including blood-based risk prediction and MRI-targeted biopsies outperform prostate cancer screening using prostate-specific antigen and systematic prostate biopsies? - protocol of the randomised study STHLM3MRI.,"INTRODUCTION Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and overdiagnosis of low-risk cancers. The STHLM3 trial has paved way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer. Targeted prostate biopsies based on MRI images have shown non-inferior sensitivity to detect significant prostate cancer and decrease the number of biopsies and non-significant cancers among men referred for prostate biopsy in clinical practice. The strategy of the STHLM3-MRI project is to study an improved diagnostic pathway including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies. METHODS This study compares prostate cancer detection using prostate-specific antigen (PSA) and systematic biopsies to the improved pathway for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context. The study will recruit 10 000 participants during 1 June 2018 to 1 June 2020 combining a paired and randomised design. Participants are grouped by PSA and Stockholm3 test level. Men with Stockholm3 ≥11% or PSA ≥3 ng/mL are randomised to systematic or MRI-targeted biopsies. This protocol follows SPIRIT guidelines. Endpoints include the number of detected prostate cancers, number of performed biopsy procedures and number of performed MRIs. Additional aims include to assess the health economic consequences and development of automated image-analysis. ETHICS AND DISSEMINATION The study is approved by the regional ethical review board in Stockholm (2017-1280/31). The study findings will be published in peer-review journals. Findings will also be disseminated by conference/departmental presentations and by media. TRIAL REGISTRATION NUMBER NCT03377881; Pre-results.",2019,Targeted prostate biopsies based on MRI images have shown non-inferior sensitivity to detect significant prostate cancer and decrease the number of biopsies and non-significant cancers among men referred for prostate biopsy in clinical practice.,['10 000 participants during 1 June 2018 to 1 June 2020 combining a paired and randomised design'],['prostate-specific antigen (PSA'],"['number of detected prostate cancers, number of performed biopsy procedures and number of performed MRIs']","[{'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",10000.0,0.0892321,Targeted prostate biopsies based on MRI images have shown non-inferior sensitivity to detect significant prostate cancer and decrease the number of biopsies and non-significant cancers among men referred for prostate biopsy in clinical practice.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nordström', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Jäderling', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Carlsson', 'Affiliation': 'Patient area Pelvic Cancer, Theme Cance Karolinska University Hospital Solna, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Solna, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-027816'] 717,31201193,Adaptive deep brain stimulation as advanced Parkinson's disease treatment (ADAPT study): protocol for a pseudo-randomised clinical study.,"INTRODUCTION Adaptive deep brain stimulation (aDBS), based on the detection of increased beta oscillations in the subthalamic nucleus (STN), has been assessed in patients with Parkinson's disease (PD) during the immediate postoperative setting. In these studies, aDBS was shown to be at least as effective as conventional DBS (cDBS), while stimulation time and side effects were reduced. However, the effect of aDBS on motor symptoms and stimulation-induced side effects during the chronically implanted phase (after the stun effect of DBS placement has disappeared) has not yet been determined. METHODS AND ANALYSIS This protocol describes a single-centre clinical study in which aDBS will be tested in 12 patients with PD undergoing battery replacement, with electrodes implanted in the STN, and as a proof of concept in the internal globus pallidus. Patients included will be allocated in a pseudo-randomised fashion to a three-condition (no stimulation/cDBS/ aDBS), cross-over design. A battery of tests will be conducted and recorded during each condition, which aim to measure the severity of motor symptoms and side effects. These tests include a tablet-based tapping test, a subscale of the Movement Disorder Society-unified Parkinson's disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test. SubMDS-UPDRS and SIT recordings will be blindly assessed by independent raters. Data will be analysed using a linear mixed-effects model. ETHICS AND DISSEMINATION This protocol was approved by the Ethical Committee of the University Medical Centre Groningen, where the study will be carried out. Data management and compliance to research policies and standards of our centre, including data privacy, storage and veracity, will be controlled by an independent monitor. All the scientific findings derived from this protocol are aimed to be made public through publication of articles in international journals. TRIAL REGISTRATION NUMBER NTR 5456; Pre-results.",2019,"These tests include a tablet-based tapping test, a subscale of the Movement Disorder Society-unified Parkinson's disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test.","[""patients with Parkinson's disease (PD) during the immediate postoperative setting"", '12 patients with PD undergoing battery replacement, with electrodes implanted in the STN, and as a proof of concept in the internal globus pallidus']","['Adaptive deep brain stimulation (aDBS', 'aDBS', 'Adaptive deep brain stimulation']","['motor symptoms and stimulation-induced side effects', ""Movement Disorder Society-unified Parkinson's disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test"", 'conventional DBS (cDBS), while stimulation time and side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0017651', 'cui_str': 'Pallidum'}]","[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",12.0,0.107162,"These tests include a tablet-based tapping test, a subscale of the Movement Disorder Society-unified Parkinson's disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-029652'] 718,30095536,Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab.,"BACKGROUND Leucine-rich repeat and immunoglobulin domain-containing Nogo receptor-interacting protein 1 (LINGO-1) is a key suppressor of oligodendrocyte differentiation and axonal remyelination and regeneration. This analysis evaluated the potential benefit of opicinumab, a human monoclonal antibody against LINGO-1, vs placebo on exploratory clinical endpoints of patient-reported vision-related functioning and high-contrast visual acuity (HCVA) in RENEW participants with acute optic neuritis (AON). METHODS Participants were randomized to 100 mg/kg opicinumab intravenous or placebo every 4 weeks (6 infusions). Assessments were conducted in the per-protocol (PP) population and included: 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), 10-item Neuro-Ophthalmic Supplement (NOS-10), and HCVA. RESULTS The opicinumab group (n = 33) had worse mean (SD) baseline patient-reported vision-related functioning scores vs placebo (n = 36): NEI-VFQ-25 composite, 75.5 (17.6) vs 79.0 (16.6); NOS-10 composite, 63.6 (19.8) vs 69.8 (21.2), respectively. By Week 24, the placebo and opicinumab groups experienced substantial mean improvements from baseline (NEI-VFQ-25 composite, 15.17 vs 13.51 [difference (95% CI): -1.66 (-5.11 to 1.78)]; NOS-10 composite, 17.40 vs 16.04 [difference (95% CI): -1.35 (-7.38 to 4.67)]). Between-treatment differences in mean change from baseline were not significantly different at any time point. Analysis of covariance-adjusted mean recovery from baseline in HCVA at Week 24 for the affected eyes was 11.8 and 8.7 letters for placebo and opicinumab, respectively (P = 0.202). CONCLUSIONS Most participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage. Average scores after recovery remained lower than those of published disease-free control groups. These results provide important information on visual function recovery in patients with AON, as measured by NEI-VFQ-25 and NOS-10.",2019,"Most participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage.","['With Acute Optic Neuritis', 'patient-reported vision-related functioning and high-contrast visual acuity (HCVA) in RENEW participants with acute optic neuritis (AON', 'Participants']","['placebo', 'opicinumab intravenous or placebo']","['worse mean (SD) baseline patient-reported vision-related functioning scores', 'Initial Impairment and Recovery of Vision-Related Functioning', 'visual function recovery', 'substantial recovery', '25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), 10-item Neuro-Ophthalmic Supplement (NOS-10), and HCVA']","[{'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550038', 'cui_str': 'opicinumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.708058,"Most participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Petrillo', 'Affiliation': 'Department of Value and Access (JP), Biostatistics (YC, LX), and Clinical Development (DC), Biogen, Cambridge, Massachusetts; and Departments of Neurology, Population Health, and Ophthalmology (LB and SG), New York University School of Medicine, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Balcer', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Galetta', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000697'] 719,30246505,Oral sweet solution to prevent pain during neonatal hip examination: a randomised controlled trial.,"AIM To determine if oral glucose can have a pain-relieving effect during routine hip examinations in newborn infants. METHODS In this randomised controlled study 100 newborn infants undergoing the routine physical examination including the potentially painful hip examination were included between March 2016 and April 2017. Fifty infants were randomised to water (control) and 50 to oral glucose (intervention) before their examination. Pain was assessed using crying time, Astrid Lindgren and Lund Children's Hospital Pain and Stress Assessment Scale (ALPS-Neo) and Visual analogue scale (VAS). RESULTS Total crying time (p = 0.006), crying time during the hip examination (p = 0.026), ALPS-Neo (p = 0.004) and VAS (p = 0.006) (when assessed by the physician) were all significantly decreased in the group of infants receiving glucose. VAS assessment made by the parents did not reach statistical significance (p = 0.127). CONCLUSION Oral glucose given before the examination has a pain-relieving effect during the hip examination in healthy newborn infants.",2019,"RESULTS Total crying time (p = 0.006), crying time during the hip examination (p = 0.026), ALPS-Neo (p = 0.004) and VAS (p = 0.006)","['newborn infants', 'during neonatal hip examination', 'Fifty infants', 'healthy newborn infants', '100 newborn infants undergoing the routine physical examination including the potentially painful hip examination were included between March 2016 and April 2017']","['water (control) and 50 to oral glucose (intervention', 'Oral sweet solution']","['Total crying time', 'crying time', 'ALPS-Neo', 'pain', 'Pain', 'VAS', ""crying time, Astrid Lindgren and Lund Children's Hospital Pain and Stress Assessment Scale (ALPS-Neo) and Visual analogue scale (VAS""]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0199262', 'cui_str': 'Hip examination (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4551516', 'cui_str': 'Painful hips'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",50.0,0.0594792,"RESULTS Total crying time (p = 0.006), crying time during the hip examination (p = 0.026), ALPS-Neo (p = 0.004) and VAS (p = 0.006)","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Olsson', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Pettersson', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ohlin', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14588'] 720,31639512,Smoking abstinence effects on emotion dysregulation in adult cigarette smokers with and without attention-deficit/hyperactivity disorder.,"BACKGROUND Cigarette smoking is robustly associated with attention-deficit/hyperactivity disorder (ADHD), but little is known about psychological mechanisms accounting for this comorbid relationship. This study examined difficulties in emotion regulation, or emotion dysregulation, among adult cigarette smokers with and without ADHD. Emotion dysregulation was predicted to be higher in an ADHD group at screening and after 24 -h smoking abstinence compared to a non-ADHD group. METHODS Cigarette smokers with (n = 19) and without (n = 20) ADHD completed a screening visit, baseline visit, and two experimental visits: smoking as usual (i.e., smoking satiated) and after biochemically-verified 24 -h smoking abstinence (i.e., smoking abstinent). Three emotion dysregulation rating scales (two self-report and one clinician rated) were administered at the screening visit and experimental sessions. Experimental sessions also included two emotion dysregulation behavioral tasks. RESULTS The ADHD group scored higher on all three rating scales at screening (p's < .001). For experimental sessions, group (ADHD, non-ADHD) x condition (smoking satiated, smoking abstinence) interactions were not significant across measures. However, group main effects emerged indicating higher emotion dysregulation in the ADHD group across all measures (p's < .001). Main effects also emerged for experimental condition, but were more mixed across emotion dysregulation measures. CONCLUSIONS Emotion dysregulation was higher among adult smokers with ADHD and during smoking abstinence across diagnostic groups, suggesting that this malleable psychological mechanism plays a role in smoking both for those with and without ADHD-such findings can inform treatment and prevention efforts.",2019,"However, group main effects emerged indicating higher emotion dysregulation in the ADHD group across all measures (p's < .001).","['adult smokers with ADHD', 'Cigarette smokers with (n\u202f=\u202f19) and without (n\u202f=\u202f20) ADHD completed a screening visit, baseline visit, and two experimental visits: smoking as usual (i.e., smoking satiated) and after biochemically-verified 24\u202f-h smoking abstinence (i.e., smoking abstinent', 'adult cigarette smokers with and without attention-deficit/hyperactivity disorder', 'adult cigarette smokers with and without ADHD']",[],"['Emotion dysregulation', 'emotion dysregulation rating scales', 'emotion dysregulation', 'higher emotion dysregulation', 'emotion regulation, or emotion dysregulation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.0125787,"However, group main effects emerged indicating higher emotion dysregulation in the ADHD group across all measures (p's < .001).","[{'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. Electronic address: john.mitchell@duke.edu.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Durham Veterans Affairs Medical Center, Durham, NC, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'School of Nursing, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Training and Department of Psychology, University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107594'] 721,31135812,Association of Nonfasting vs Fasting Lipid Levels With Risk of Major Coronary Events in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm.,"Importance Recent guidelines have recommended nonfasting for routine testing of lipid levels based on comparisons of nonfasting and fasting populations. However, no previous study has examined the association of cardiovascular outcomes with fasting vs nonfasting lipid levels measured in the same individuals. Objective To compare the association of nonfasting and fasting lipid levels with prospectively ascertained coronary and vascular outcomes and to evaluate whether a strategy of using nonfasting instead of fasting lipid level measurement would result in misclassification of risk for individuals undergoing evaluation for initiation of statin therapy. Design, Setting, and Participants This post hoc prospective follow-up of a randomized clinical trial included 8270 of 10 305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years). Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018. Multivariable Cox models, adjusted for cardiovascular risk factors, were calculated for 40-mg/dL (1-mmol/L) higher values of nonfasting and fasting lipids. Main Outcomes and Measures The trial's primary end point consisted of major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events]). Secondary analyses examined atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events]). Results Among the 8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years), nonfasting samples had modestly higher triglyceride levels and similar cholesterol levels compared to fasting samples. Associations of nonfasting lipid levels with coronary events were similar to those for fasting lipid levels. For example, adjusted hazard ratios (HRs) per 40-mg/dL of low-density lipoprotein cholesterol were 1.32 (95% CI, 1.08-1.61; P = .007) for nonfasting levels and 1.28 (95% CI, 1.07-1.55; P = .008) for fasting levels. For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels. Results were consistent by randomized treatment arm (atorvastatin calcium, 10 mg/d, or placebo) and similar for ASCVD events. Concordance of fasting and nonfasting lipid levels for classifying participants into appropriate ASCVD risk categories was high (94.8%). Conclusions and Relevance Measurement of nonfasting and fasting lipid levels yields similar results in the same individuals for association with incident coronary and ASCVD events. These results suggest that routine measurement of nonfasting lipid levels may help facilitate ASCVD risk screening and treatment, including consideration of when to initiate statin therapy.",2019,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","['individuals undergoing evaluation for initiation of statin therapy', 'Data were collected from February 1, 1998, to December 31, 2002, and analyzed from February 1, 2016, to November 30, 2018', '8270 of 10\u202f305 participants from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) with nonfasting and fasting lipid levels measured 4 weeks apart (including 6855 participants with no prior vascular disease) (median follow-up, 3.3 years; interquartile range, 2.8-3.6 years', '8270 participants (82.1% male; mean [SD] age, 63.4 [8.5] years']","['atorvastatin calcium', 'placebo']","['atherosclerotic cardiovascular disease (ASCVD) events (including MI, stroke, and ASCVD death [351 events', 'major coronary events (nonfatal myocardial infarction [MI] and fatal coronary heart disease [212 events', 'Association of Nonfasting vs Fasting Lipid Levels', 'cardiovascular risk factors', 'Concordance of fasting and nonfasting lipid levels', 'low-density lipoprotein cholesterol', 'nonfasting lipid levels', 'triglyceride levels and similar cholesterol levels', 'nonfasting levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0286650', 'cui_str': 'Atorvastatin calcium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2585491', 'cui_str': 'Nonfasting'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10305.0,0.0492221,"For the primary prevention group, adjusted HRs were 1.42 (95% CI, 1.13-1.78; P = .003) for nonfasting levels and 1.37 (95% CI, 1.11-1.69; P = .003) for fasting levels.","[{'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'C Lan', 'Initials': 'CL', 'LastName': 'Chang', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'M Vinayaga', 'Initials': 'MV', 'LastName': 'Moorthy', 'Affiliation': ""Center for Lipid Metabolomics, Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0392'] 722,30882238,Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus.,"BACKGROUND In DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the composite end point of cardiovascular death/hospitalization for heart failure (HHF) in a broad population of patients with type 2 diabetes mellitus. However, the impact of baseline left ventricular ejection fraction (EF) on the clinical benefit of sodium-glucose cotransporter 2 inhibition is unknown. METHODS In the DECLARE-TIMI 58 trial, baseline heart failure (HF) status was collected from all patients, and EF was collected when available. HF with reduced EF (HFrEF) was defined as EF <45%. Outcomes of interest were the composite of cardiovascular death/HHF, its components, and all-cause mortality. RESULTS Of 17 160 patients, 671 (3.9%) had HFrEF, 1316 (7.7%) had HF without known reduced EF, and 15 173 (88.4%) had no history of HF at baseline. Dapagliflozin reduced cardiovascular death/HHF more in patients with HFrEF (hazard ratio [HR], 0.62 [95% CI, 0.45-0.86]) than in those without HFrEF (HR, 0.88 [95% CI, 0.76-1.02]; P for interaction=0.046), in whom the treatment effect of dapagliflozin was similar in those with HF without known reduced EF (HR, 0.88 [95% CI, 0.66-1.17]) and those without HF (HR, 0.88 [95% CI, 0.74-1.03]). Whereas dapagliflozin reduced HHF both in those with (HR, 0.64 [95% CI, 0.43-0.95]) and in those without HFrEF (HR, 0.76 [95% CI, 0.62-0.92]), it reduced cardiovascular death only in patients with HFrEF (HR, 0.55 [95% CI, 0.34-0.90]) but not in those without HFrEF (HR, 1.08 [95% CI, 0.89-1.31]; P for interaction=0.012). Likewise, dapagliflozin reduced all-cause mortality in patients with HFrEF (HR, 0.59 [95% CI, 0.40-0.88;) but not in those without HFrEF (HR, 0.97 [95% CI, 0.86-1.10]; P for interaction=0.016). CONCLUSIONS In the first sodium-glucose cotransporter 2 inhibitor cardiovascular outcome trial to evaluate patients with type 2 diabetes mellitus stratified by EF, we found that dapagliflozin reduced HHF in patients with and without HFrEF and reduced cardiovascular death and all-cause mortality in patients with HFrEF. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534.",2019,"Whereas dapagliflozin reduced HHF both in those with (HR, 0.64","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus stratified by EF', 'patients with HFrEF', 'Myocardial Infarction 58', 'Type 2 Diabetes Mellitus']","['dapagliflozin reduced HHF', 'sodium-glucose cotransporter', 'Dapagliflozin', 'dapagliflozin']","['composite of cardiovascular death/HHF, its components, and all-cause mortality', 'cardiovascular death', 'cardiovascular death/HHF', 'baseline heart failure (HF) status', 'HF with reduced EF (HFrEF', 'Heart Failure and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",17160.0,0.207119,"Whereas dapagliflozin reduced HHF both in those with (HR, 0.64","[{'ForeName': 'Eri T', 'Initials': 'ET', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (E.T.K.).'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Silverman', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston (M.G.S.).'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Ontario, Canada (L.A.L.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, UK (J.P.H.W.).'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, University of Colorado, Denver (M.P.B.).'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (A.S.D.).""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Department of Medicine (Cardiology), Tokai University, Isehara, Japan (S.G.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.A.J., I.G.-N., P.J., A.M.L.).'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.A.J., I.G.-N., P.J., A.M.L.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.A.J., I.G.-N., P.J., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.A.J., I.G.-N., P.J., A.M.L.).'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (O.M., A.C., I.R.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.040130'] 723,32000099,Who is willing to participate in research? A screening model for an anxiety and depression trial in the epilepsy clinic.,"OBJECTIVE Anxiety and depression in epilepsy are prevalent, associated with poor outcomes, underrecognized, undertreated, and thus a key area of need for treatment research. The objective of this study was to assess factors associated with research participation among epilepsy clinic patients who screened positive for anxiety or depression. This was accomplished by characterizing clinical and psychiatric factors among patients seen in an epilepsy clinic and evaluating which factors were associated with consent for potential research participation, via a combined clinical and research screening model. METHODS In a pragmatic trial of anxiety and depression treatment in epilepsy, individuals with a positive screen for anxiety and/or depression at a routine epilepsy clinic visit were invited to opt-in (via brief electronic consent) to further eligibility assessment for a randomized treatment study. Information on psychiatric symptoms and treatment characteristics were collected for dual clinical care and research screening purposes. Cross-sectional association of demographic, clinical, and psychiatric factors with opting-in to research was analyzed by multiple logistic regression. RESULTS Among N = 199 unique adults with a first positive screen for anxiety and/or depression among 786 total screening events, 154 (77.4%) opted-in to further potential research assessment. Higher depression scores and current treatment with an antidepressant were independently associated with opting-in to research (depression odds ratio (OR) = 1.13 per 1-point increase in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) score, p = 0.028, 95% confidence interval (CI): 1.01-1.26; antidepressant OR = 2.37, p = 0.041, CI: 1.04-5.41). Nearly half of the 199 individuals (43.7%) with anxiety and/or depression symptoms were already being treated with an antidepressant, and 46.7% were receiving neither antidepressant therapy nor mental health specialty care. One-quarter (24.1%) reported a past psychiatric hospitalization, yet only half of these individuals were receiving mental health specialty care. SIGNIFICANCE Our results demonstrate a high willingness to participate in research using a brief electronic consent approach at a routine clinic visit. Adults with persistent anxiety or depression symptoms despite antidepressant therapy and those with higher depression scores were more willing to consider a randomized treatment study. This has implications for future study design, as individuals already on treatment or those with more severe symptoms are often excluded from traditional research designs. We also found a high burden of psychiatric disease and high prevalence of persistent symptoms despite ongoing antidepressant treatment.",2020,Nearly half of the 199 individuals (43.7%) with anxiety,"['Among N\u202f=\u202f199 unique adults with a first positive screen for anxiety and/or depression among 786 total screening events, 154 (77.4%) opted-in to further potential research assessment', 'epilepsy clinic patients who screened positive for anxiety or depression', 'epilepsy, individuals with a positive screen for anxiety and/or depression at a routine epilepsy clinic visit', '199 individuals (43.7%) with anxiety', 'Adults with persistent anxiety or depression symptoms despite antidepressant therapy and those with higher depression scores']",[],"['past psychiatric hospitalization', 'Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) score', 'Higher depression scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035168'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",[],"[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0539495,Nearly half of the 199 individuals (43.7%) with anxiety,"[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Munger Clary', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: hmungerc@wakehealth.edu.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Croxton', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: croxrd13@alumni.wfu.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Allan', 'Affiliation': 'Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: jallan@wakehealth.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lovato', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: jlovato@wakehealth.edu.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Brenes', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Wake Forest University, Winston-Salem, NC, USA. Electronic address: gbrenes@wakehealth.edu.'}, {'ForeName': 'Beverly M', 'Initials': 'BM', 'LastName': 'Snively', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: bmellen@wakehealth.edu.'}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Wan', 'Affiliation': 'Neuroscience Graduate Program, Wake Forest University, Winston-Salem, NC, USA. Electronic address: miwan@wakehealth.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kimball', 'Affiliation': 'Department of Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Wong', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Cormac A', 'Initials': 'CA', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: odonovan@wakehealth.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Conner', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: kconner@wakehealth.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Jones', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: pduncan@wakehealth.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.106907'] 724,31189680,NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study.,"INTRODUCTION Robot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP. METHODS NeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life. ETHICS AND DISSEMINATION NeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications. TRIAL REGISTRATION NUMBER NCT03317990.",2019,Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP.,['men with localised prostate cancer (NeuroSAFE PROOF'],"['NeuroSAFE RALP (intervention) or standard RALP (control', 'Robot-assisted laparoscopic prostatectomy (RALP', 'NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy']","['definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life', 'PSM rates', 'Potency and urinary continence']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}]",,0.274382,Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP.,"[{'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Dinneen', 'Affiliation': 'Department of Urology, University College Hospital London, London, UK.'}, {'ForeName': 'Aiman', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology, University College Hospital London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Department of Histopathology, University College Hospital London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Briggs', 'Affiliation': 'Department of Urology, University College Hospital London, London, UK.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Nathan', 'Affiliation': 'Department of Urology, University College Hospital London, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery & Interventional Science, University College London Medical School, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grierson', 'Affiliation': 'Division of Surgery & Interventional Science, University College London Medical School, London, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery & Interventional Science, University College London Medical School, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Persad', 'Affiliation': 'North Bristol NHS Trust, Westbury on Trym, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Oakley', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, Sheffield, UK.'}, {'ForeName': 'Jim M', 'Initials': 'JM', 'LastName': 'Adshead', 'Affiliation': 'Department of Urology, Lister Hospital, Stevenage, UK.'}, {'ForeName': 'Hartwig', 'Initials': 'H', 'LastName': 'Huland', 'Affiliation': 'Martini Klinik, Department of Urology, University Hospital Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Haese', 'Affiliation': 'Martini Klinik, Department of Urology, University Hospital Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Shaw', 'Affiliation': 'Department of Urology, University College Hospital London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028132'] 725,32147484,"Safety and Efficacy of 48 Weeks REP 2139 or REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a in Patients With Chronic HBV Infection Naïve to Nucleos(t)ide Therapy.","BACKGROUND & AIMS Nucleic acid polymers (NAPs) inhibit assembly and secretion of hepatitis B virus (HBV) subviral particles. We performed an open-label, phase 2 study of the safety and efficacy of the NAPs REP 2139 or REP 2165 combined with tenofovir disoproxil fumarate (TDF) and pegylated interferon alfa-2a (pegIFN) in patients with chronic HBV infection who were negative for hepatitis B e antigen. METHODS Following 24 weeks TDF therapy, 40 patients were randomly assigned to groups that received 48 weeks of experimental therapy (TDF + pegIFN + REP 2139-Mg or REP 2165-Mg) or 24 weeks of control therapy (TDF + pegIFN) followed by 48 weeks of experimental therapy. Patients were then followed for a treatment-free period of 48 weeks. Primary outcomes were the safety and tolerability of REP 2139-Mg or REP 2165-Mg in combination with TDF + pegIFN compared with TDF + pegIFN alone through the first 48 weeks of therapy and subsequently throughout 48 weeks of NAP-based combination therapy (treatment weeks 24-72 in the experimental group and weeks 48-96 in the control group). Secondary outcomes were reductions in hepatitis B surface antigen (HBsAg) in control and experimental groups over the first 48 weeks of the study and throughout 48 weeks of combination therapy and virologic control (HBsAg positive, HBV DNA below 2000 IU/mL, normal level of alanine aminotransferase) or functional cure (HBsAg below 0.05 IU/mL, HBV DNA target not detected, normal level of alanine aminotransferase) after removal of all therapy. RESULTS Levels of HBsAg, anti-HBs, and HBV DNA did not differ significantly between the groups given REP 2139 vs REP 2165. PegIFN-induced thrombocytopenia (P = .299 vs controls) and neutropenia (P = .112 vs controls) were unaffected by NAPs (REP 2139 vs REP 2165). Increases in levels of transaminases were significantly more frequent (P < .001 vs controls) and greater (P = .002 vs controls) in the NAP groups (but did not produce symptoms), correlated with initial decrease in HBsAg, and normalized during therapy and follow-up. During the first 24 weeks of TDF and pegIFN administration, significantly higher proportions of patients in NAP groups had decreases in HBsAg to below 1 IU/mL (P < .001 vs control) and HBsAg seroconversion (P = .046 vs control). At the time patients completed the TDF + pegIFN + NAP regimen, HBsAg levels were 0.05 IU/mL or lower in 24/40 participants (all with seroconversion up to 233,055 mIU/mL). During 48 weeks of treatment-free follow-up, virologic control persisted in 13 of 40 participants (2 lost to follow-up after 24 weeks), whereas functional cure persisted in 14 of 40 participants (all completing 48 weeks of follow-up) with persistent HBsAg seroconversion. One participant had a viral rebound during follow-up with hepatic decompensation and was placed on TDF therapy. CONCLUSIONS In a phase 2 randomized trial, we found that addition of NAPs to TDF + pegIFN did not alter tolerability and significantly increased rates of HBsAg loss and HBsAg seroconversion during therapy and functional cure after therapy. Clinicaltrials.gov no: NCT02565719.",2020,"RESULTS Levels of HBsAg, anti-HBs, and HBV DNA did not differ significantly between the groups given REP 2139 vs REP 2165.","['Patients', 'patients with negative chronic HBV infection who were negative for HB e antigen (HBeAg', '40 patients']","['REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a', 'NAP-based combination therapy', 'NAPs to TDF + pegIFN', 'NAPs REP 2139 or REP 2165 combined with tenofovir disoproxil fumarate (TDF) and pegylated interferon alfa-2a (pegIFN', 'experimental therapy (TDF + pegIFN + REP 2139-Mg or REP 2165-Mg) or 24 weeks of control therapy (TDF + pegIFN']","['Safety and Efficacy', 'HBsAg seroconversion', 'PegIFN-induced thrombocytopenia', 'rates of HBsAg loss and HBsAg seroconversion', 'functional cure', 'Levels of HBsAg, anti-HBs, and HBV DNA', 'virologic control (HBsAg positive, HBV DNA below 2000 IU/mL, normal level of alanine aminotransferase) or functional cure (HBsAg below 0.05 IU/mL, HBV DNA target not detected, normal level of alanine aminotransferase', 'tolerability', 'neutropenia', 'levels of transaminases', 'safety and tolerability of REP 2139-Mg or REP 2165-Mg', 'TDF + pegIFN + NAP regimen, HBsAg levels', 'HBsAg']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0312906', 'cui_str': ""Blood group antigen rh''""}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}]","[{'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C0391001', 'cui_str': 'peginterferon alfa-2a'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0949266', 'cui_str': 'Investigational Treatments'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0149709', 'cui_str': 'HBsAg positive'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0442737', 'cui_str': 'Not detected (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}]",40.0,0.0461698,"RESULTS Levels of HBsAg, anti-HBs, and HBV DNA did not differ significantly between the groups given REP 2139 vs REP 2165.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Bazinet', 'Affiliation': 'Replicor Inc., Montreal, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pântea', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Placinta', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova.'}, {'ForeName': 'Iurie', 'Initials': 'I', 'LastName': 'Moscalu', 'Affiliation': 'ARENSIA Exploratory Medicine, Republican Clinical Hospital Chișinău, Moldova.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Cebotarescu', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Cojuhari', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova.'}, {'ForeName': 'Pavlina', 'Initials': 'P', 'LastName': 'Jimbei', 'Affiliation': 'Toma Ciorbă Infectious Clinical Hospital, Chișinău, Republic of Moldova.'}, {'ForeName': 'Liviu', 'Initials': 'L', 'LastName': 'Iarovoi', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Smesnoi', 'Affiliation': 'Toma Ciorbă Infectious Clinical Hospital, Chișinău, Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Musteata', 'Affiliation': 'Toma Ciorbă Infectious Clinical Hospital, Chișinău, Republic of Moldova.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Jucov', 'Affiliation': 'Department of Infectious Diseases, Nicolae Testemiţanu State University of Medicine and Pharmacy, Chișinău, Republic of Moldova; ARENSIA Exploratory Medicine, Republican Clinical Hospital Chișinău, Moldova.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Dittmer', 'Affiliation': 'Institute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Adalbert', 'Initials': 'A', 'LastName': 'Krawczyk', 'Affiliation': 'Institute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; Department of Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vaillant', 'Affiliation': 'Replicor Inc., Montreal, Canada. Electronic address: availlant@replicor.com.'}]",Gastroenterology,['10.1053/j.gastro.2020.02.058'] 726,32147485,No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study.,"PURPOSE To assess the functional outcomes of patients included in the Stability Study randomized controlled trial comparing anterior cruciate ligament reconstruction (ACLR) alone with ACLR with lateral extra-articular tenodesis (LET) at 6, 12, and 24 months postoperatively. METHODS Six hundred eighteen patients undergoing ACLR, all under the age of 25 years either returning to contact pivoting sport or displaying signs of high-grade rotatory laxity or generalized ligamentous laxity, were randomly assigned to receive ACLR alone or ACLR plus LET. A total of 356 of these patients were randomized at centers participating in the functional assessments. Our primary outcome was Limb Symmetry Index, calculated using a series of 4-hop tests at 6, 12, and 24 months postoperatively. Secondary outcome measures included pain, patient-reported function, and isokinetic strength testing. RESULTS We found no statistically significant difference in the proportion of patients either unwilling or unfit to complete the hop testing in the ACLR alone or ACLR with LET group at 6 months (40 vs 40 respectively; P = 1.00), 12 months (25 vs 27; P = .76), and 24 months (21 vs 23; P = .87). Of those who completed hop testing, there were no statistically significant differences between groups in Limb Symmetry Index at 6, 12, or 24 months. Self-reported function (Lower Extremity Functional Score) significantly favored the ACLR alone group at 3 (P = .01) and 6 months (P = .02) postoperative but was similar by 12 months postoperative. Pain scores (P4) also showed a statistically significant difference in favor of the ACL alone group, but this also resolved by 6 months. Quadriceps peak torque (P = .03) and average power (P = .01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months postoperative (P = .11 and P = .32, respectively). CONCLUSIONS The addition of a LET to ACLR results in slightly increased pain, a mild reduction in quadriceps strength, and reduced subjective functional recovery up to 6 months postoperatively. However, these differences do not have any impact on objective function as measured by hop test limb symmetry index. LEVEL OF EVIDENCE I, Randomized Controlled Trial.",2020,"Quadriceps peak torque (p=0.03) and average power (p=0.01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months post-operative (p=0.11and p=0.32 respectively). ","['young active patients', 'Six hundred and eighteen patients undergoing ACLR, all under the age of 25 either returning to contact pivoting sport or displaying signs of high grade rotatory laxity or generalized ligamentous laxity', 'A total of 356 of these patients were randomized at centers participating in the functional assessments']","['anterior cruciate ligament reconstruction (ACLR) alone to ACLR with lateral extra-articular tenodesis (LET', 'ACLR alone or ACLR plus LET', 'Anterior Cruciate Ligament Reconstruction']","['Functional Outcomes', 'quadriceps strength and reduced subjective functional recovery', 'pain', 'Pain scores (P4', 'Self-reported function (Lower Extremity Functional Score', 'Quadriceps peak torque', 'Limb Symmetry Index (LSI', 'pain, patient-reported function and isokinetic strength testing']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",618.0,0.0864832,"Quadriceps peak torque (p=0.03) and average power (p=0.01) were also significantly different in favor of the ACLR alone group at 6 months postoperative; however, these were similar between groups by 12 months post-operative (p=0.11and p=0.32 respectively). ","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada; London Health Sciences Centre, London, Ontario, Canada. Electronic address: alan.getgood@uwo.ca.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hewison', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada; Faculty of Health Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Litchfield', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heard', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Buchko', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Hiemstra', 'Affiliation': 'Banff Sport Medicine, Banff, Alberta, Canada.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Willits', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada; Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacDonald', 'Affiliation': 'Pan Am Clinic, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.02.015'] 727,31818839,Testing the effectiveness of a weight loss intervention to enhance self-regulation in adults who are obese: protocol for a randomised controlled trial.,"INTRODUCTION Previous trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss. METHODS AND ANALYSES A parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m 2 will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks' follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire. ETHICS AND DISSEMINATION This trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER ISRCTN14148239, prerecruitment. PROTOCOL VERSION Version 1.1, 7 December 2018.",2019,One hundred participants with a body mass index ≥30 kg/m 2 will be randomised to either the control or intervention group.,"['One hundred participants with a body mass index ≥30 kg/m 2', 'adults who are obese', 'VERSION\n\n\nVersion 1.1, 7 December 2018']","['self-regulation intervention', 'weight loss intervention']","['weight loss', 'outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention', 'qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire', 'weight change']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]","[{'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",100.0,0.142244,One hundred participants with a body mass index ≥30 kg/m 2 will be randomised to either the control or intervention group.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Frie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK kerstin.frie@phc.ox.ac.uk.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Hartmann-Boyce', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031572'] 728,31138170,Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial.,"BACKGROUND Insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with Williams-Beuren syndrome. Restoring sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial blood pressure. METHODS The aim of this study was to assess the efficacy and safety of minoxidil on Intima Media Thickness (IMT) on the right common carotid artery after twelve-month treatment in patient with Williams-Beuren syndrome. We performed a randomized placebo controlled double blind trial. All participants were treated for 12 months and followed for 18 months. The principal outcome was assessed by an independent adjudication committee blinded to the allocated treatment groups. RESULTS The principal outcome was available for 9 patients in the placebo group and 8 patients in the minoxidil group. After 12-month treatment, the IMT in the minoxidil group increased by 0.03 mm (95% CI -0.002, 0.06) compared with 0.01 mm (95%CI - 0.02, 0.04 mm) in the placebo group (p = 0.4). Two serious adverse events unrelated to the treatment occurred, one in the minoxidil and 1 in the placebo group. After 18 months, the IMT increased by 0.07 mm (95% CI 0.04, 0.10 mm) in the minoxidil compared with 0.01 mm (95% CI -0.02, 0.04 mm) in the placebo group (p = 0.008). CONCLUSION Our results suggest a slight increase after 12 and 18-month follow-up in IMT. More understanding of the biological changes induced by minoxidil should better explain its potential role on elastogenesis in Williams-Beuren syndrome. TRIALS REGISTRATION US National Institutes of Health Clinical Trial Register (NCT00876200). Registered 3 April 2009 (retrospectively registered).",2019,"After 18 months, the IMT increased by 0.07 mm (95% CI 0.04, 0.10 mm) in the minoxidil compared with 0.01 mm (95% CI -0.02, 0.04 mm) in the placebo group (p = 0.008). ","['children with Williams-Beuren syndrome', 'children with Williams Beuren Syndrome', 'patient with Williams-Beuren syndrome']","['minoxidil', 'Minoxidil', 'placebo']","['IMT', 'arterial blood pressure', 'Intima Media Thickness (IMT', 'efficacy and safety', 'arterial wall hypertrophy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175702', 'cui_str': 'Williams-Beuren Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3495851', 'cui_str': 'Arterial wall hypertrophy'}]",,0.540551,"After 18 months, the IMT increased by 0.07 mm (95% CI 0.04, 0.10 mm) in the minoxidil compared with 0.01 mm (95% CI -0.02, 0.04 mm) in the placebo group (p = 0.008). ","[{'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Kassai', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Service de Pharmacotoxicologie, CHU-Lyon, F-69677, Bron, France. behrouz.kassai-koupai@chu-lyon.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bouyé', 'Affiliation': ""CHU d'Angers, department of Vascular Studies, Centre de Recherche Clinique Angers, Angers, France.""}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Gilbert-Dussardier', 'Affiliation': 'CHU de Poitiers, la Milétrie Service de génétique médicale, F-86021, Poitiers, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Godart', 'Affiliation': 'CHRU de Lille, université Lille 2, EA 2693, service de cardiologie infantile et congénitale, Nord de France, hôpital cardiologique, F-59000, Lille, France.'}, {'ForeName': 'Jean-Benoit', 'Initials': 'JB', 'LastName': 'Thambo', 'Affiliation': 'CHU de Bordeaux, université de Bordeaux, service des cardiopathies congénitales, hôpital cardiologique du Haut-Lévêque, Inserm U-1045, LIRYC, institut de rythmologie et modélisation cardiaque, Bordeaux, France.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Hospices Civils de Lyon, Service de génétique médicale, INSERM U1028, CNRS UMR5292, Centre de Recherche en Neurosciences de Lyon, GENDEV Team, F-69500, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cochat', 'Affiliation': 'Hospices Civils de Lyon, Service de Néphrologie Pédiatrique, et centre de référence maladies rénales rares- Néphrogones, Filière ORKiD, -69500, Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Chirossel', 'Affiliation': ""Hospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.""}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Luong', 'Affiliation': ""Hospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Serusclat', 'Affiliation': ""Hospices Civils de Lyon, Service d'exploration fonctionnelle vasculaire, hôpital Louis Pradel, F-69500, Bron, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Canterino', 'Affiliation': 'Hospices Civils de Lyon, Service de Radiologie F-69500, Bron, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercier', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rabilloud', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pivot', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie à Usage Intérieur, plateforme Fripharm, F-69437, Lyon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Pirot', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.'}, {'ForeName': 'Tiphanie', 'Initials': 'T', 'LastName': 'Ginhoux', 'Affiliation': 'Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Service de Pharmacotoxicologie, CHU-Lyon, F-69677, Bron, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Coopman', 'Affiliation': ""Lille University Hospital, Centre d'Investigation Clinique, CIC-1403-Inserm-CH&U, F-59000, Lille, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grenet', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Gueyffier', 'Affiliation': 'Université de Lyon, F-69000, Lyon, France ; Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622, Villeurbanne, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Di-Fillippo', 'Affiliation': 'Hospices Civils de Lyon, Service de cardiologie pédiatrique, F-69500, Bron, France.'}, {'ForeName': 'Aurélia', 'Initials': 'A', 'LastName': 'Bertholet-Thomas', 'Affiliation': 'Hospices Civils de Lyon, Service de Néphrologie Pédiatrique, et centre de référence maladies rénales rares- Néphrogones, Filière ORKiD, -69500, Bron, France.'}]",BMC pediatrics,['10.1186/s12887-019-1544-1'] 729,31196899,Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial.,"INTRODUCTION Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year. METHODS AND ANALYSIS This is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration. ETHICS AND DISSEMINATION The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature. TRIAL REGISTRATION NUMBER ACTRN12618000429257; Pre-results.",2019,"The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration. ","['272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery', 'female patients (CHEWY']","['chewing gum or 4\u2009mg intravenous ondansetron', 'ondansetron', 'Chewing gum', 'peppermint-flavoured chewing gum']","['nausea, retching or vomiting', 'cessation of PONV within 2\u2009hours of administration, with no recurrence nor rescue medication requirement for 2\u2009hours after administration']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0697157', 'cui_str': 'Mentha x piperita'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",272.0,0.207491,"The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration. ","[{'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Darvall', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Britta Sylvia', 'Initials': 'BS', 'LastName': 'von Ungern-Sternberg', 'Affiliation': ""Department of Anaesthesia and Pain Management, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Centre for Epidemiology and Biostatistics and Melbourne Clinical and Translational Science Platform, University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Centre for Integrated Critical Care, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia, Royal Children's Hospital Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Tran-Duy', 'Affiliation': 'Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Middleton', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-027505'] 730,32039559,"Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial.","In a phase 2 multicenter open-label randomized trial sponsored by the National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients were randomized to a calcineurin inhibitor (CNI)-based immunosuppressive regimen (tacrolimus) (n = 21), or an investigational arm using low-dose CNI plus costimulation blockade (belatacept) with intended CNI withdrawal (n = 22). Both arms included induction therapy with rabbit ATG, mycophenolate sodium, or mycophenolate mofetil and rapid withdrawal of steroids. Enrollment and CNI withdrawal were stopped after 43/60 planned subjects had been enrolled. At that time, the rate of biopsy-proven acute rejection (BPAR) of the pancreas was low in both groups until CNI was withdrawn, with four of the five pancreas rejections occurring during or after CNI withdrawal. The rate of BPAR of kidney allografts was low in both control (9.5%) and investigational (9.1%) arms. Pancreas graft survival at 52 weeks, defined by insulin independence, was 21 (100%) in the control group and 19 (86%) in the investigational arm. One subject in the investigational arm died with functioning pancreas and kidney grafts. Renal function at week 52 was similar in both arms. Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.",2020,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"['43/60 planned subjects had been enrolled', 'SPK transplants undergoing CNI withdrawal', 'combined pancreas and kidney transplantation', 'National Institutes of Health, simultaneous pancreas-kidney (SPK) recipients']","['rabbit ATG, mycophenolate sodium or mycophenolate mofetil', 'calcineurin inhibitor (CNI) based immunosuppressive regimen (tacrolimus) (n=21) or an investigational arm using low-dose CNI plus co-stimulation blockade (belatacept) with intended CNI withdrawal', 'belatacept', 'calcineurin inhibitor withdrawal']","['Pancreas graft survival', 'Renal function', 'rate of biopsy proven acute rejection (BPAR) of the pancreas', 'rate of BPAR of kidney allografts']","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}]","[{'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]",,0.0714917,Costimulation blockade with belatacept did not provide sufficient immunosuppression to reliably prevent pancreas rejection in SPK transplants undergoing CNI withdrawal.,"[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'UCSF, San Francisco, California, USA.'}, {'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'UAB, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ikle', 'Affiliation': 'Rho Inc., Durham, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Odorico', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fridell', 'Affiliation': 'IU, Indianapolis, Indiana, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15817'] 731,31852579,3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.,"BACKGROUND Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. OBJECTIVES To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. DESIGN An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. SETTING A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. PARTICIPANTS Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. INTERVENTIONS The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. MAIN OUTCOME MEASURES The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. RESULTS Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n  = 3035; 6-month analysis, n  = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p -value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years ( p  < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. CONCLUSIONS The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. TRIAL REGISTRATION Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).",2019,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. ","['patients with high-risk stage II and III colorectal cancer', 'Adults aged ≥\u200918 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum', 'A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand', 'patients with high-risk stage II or III colorectal cancer', '6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n \u2009=\u20093035; 6-month analysis, n \u2009=\u20093030']","['oxaliplatin-containing adjuvant chemotherapy', 'Oxaliplatin and fluoropyrimidine chemotherapy', 'oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine', 'adjuvant chemotherapy']","['3-year disease-free survival rate', 'cumulative toxicity', 'disease-free survival', 'sensory neuropathy', 'Cost-effectiveness', 'toxicity, health-related quality of life and cost-effectiveness', 'Quality-of-life scores', 'disease-free survival and overall survival', 'rate of neuropathy', 'Overall survival, adverse events, neuropathy and health-related quality of life', 'safety profile and cost less', 'incremental cost comparisons and quality-adjusted life-year gains', 'Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3853050', 'cui_str': 'Cost Comparison'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C3257803', 'cui_str': 'Watery eye (finding)'}]",244.0,0.236886,"A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. ","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kerr', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Robles-Zurita', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Briggs', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hollander', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Naestved, Denmark.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Australasian Gastro-Intestinal Trials Group, Camperdown, NSW, Australia.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Harkin', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Allan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McQueen', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'Oncology Clinical Trials Office, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ashita', 'Initials': 'A', 'LastName': 'Waterston', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Medley', 'Affiliation': 'Royal United Hospital, Bath, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Cornwall, UK.'}, {'ForeName': 'Sharadah', 'Initials': 'S', 'LastName': 'Essapen', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.""}, {'ForeName': 'Amandeep S', 'Initials': 'AS', 'LastName': 'Dhadda', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Raouf', 'Affiliation': 'Barking Havering and Redbridge University Hospital NHS Trust, Barking, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rees', 'Affiliation': 'Southampton University Hospital NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rene K', 'Initials': 'RK', 'LastName': 'Olesen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Oncology, University College London, London, UK.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Azzabi', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrugia', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Brighton and Sussex University Hospital Trust, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Department of Oncology, Oxford University Hospitals Foundation Trust, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gollins', 'Affiliation': 'North Wales Cancer Treatment Centre, Rhyl, UK.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'The Christie Hospital NHS Foundation Trust, Manchester, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23640'] 732,31852697,Informed Health Choices media intervention for improving people's ability to critically appraise the trustworthiness of claims about treatment effects: a mixed-methods process evaluation of a randomised trial in Uganda.,"We developed the Informed Health Choices podcast to improve people's ability to assess claims about the effects of treatments. We evaluated the effects of the podcast in a randomised trial. OBJECTIVES We conducted this process evaluation to assess the fidelity of the intervention, identify factors that affected the implementation and impact of the intervention and could affect scaling up, and identify potential adverse and beneficial effects. SETTING The study was conducted in central Uganda in rural, periurban and urban settings. PARTICIPANTS We collected data on parents who were in the intervention arm of the Informed Health Choices study that evaluated an intervention to improve parents' ability to assess treatment effects. PROCEDURES We conducted 84 semistructured interviews during the intervention, 19 in-depth interviews shortly after, two focus group discussions with parents, one focus group discussion with research assistants and two in-depth interviews with the principal investigators. We used framework analysis to manage qualitative data, assessed the certainty of the findings using the GRADE-CERQual (Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative Research) approach, and organised findings in a logic model. OUTCOMES Proportion of participants listening to all episodes; factors influencing the implementation of the podcast; ways to scale up and any adverse and beneficial effects. RESULTS All participants who completed the study listened to the podcast as intended, perhaps because of the explanatory design and recruitment of parents with a positive attitude. This was also likely facilitated by the podcast being delivered by research assistants, and providing the participants with MP3 players. The podcast was reportedly clear, understandable, credible and entertaining, which motivated them to listen and eased implementation. No additional adverse effects were reported. CONCLUSIONS Participants experienced the podcast positively and were motivated to engage with it. These findings help to explain the short-term effectiveness of the intervention, but not the decrease in effectiveness over the following year.",2019,"No additional adverse effects were reported. ","['The study was conducted in central Uganda in rural, periurban and urban settings', 'participants with MP3 players', 'We collected data on parents who were in the intervention arm of the Informed Health Choices study']",[],"['adverse and beneficial effects', 'adverse effects']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C2350433', 'cui_str': 'MP3-Player'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",84.0,0.0909602,"No additional adverse effects were reported. ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Semakula', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nsangi', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Oxman', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway oxman@online.no.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Glenton', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lewin', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Oxman', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kaseje', 'Affiliation': 'Tropical Institute of Community Health and Development, Kisumu, Kenya.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Austvoll-Dahlgren', 'Affiliation': 'East and South, Regional Centre for Child and Youth Mental Health and Child Welfare, Oslo, Norway.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Rose', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Fretheim', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Sewankambo', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}]",BMJ open,['10.1136/bmjopen-2019-031510'] 733,31852699,Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care 'test-and-treat' strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol.,"BACKGROUND Influenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap. METHODS AND ANALYSIS The FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality. ETHICS AND DISSEMINATION Prior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER ISRCTN17197293.",2019,"The FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England.","['patients admitted to hospital due to lack of routine testing', 'adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England', '840 patients will be recruited over up to three influenza seasons', 'adults hospitalised with acute respiratory illness (FluPOC']","[""routine molecular point-of-care 'test-and-treat' strategy"", 'POCT using the FilmArray respiratory panel, or routine clinical care']","['proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4708913', 'cui_str': '840'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",840.0,0.244694,"The FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Beard', 'Affiliation': 'Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK kate.beard@uhs.nhs.uk.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Brendish', 'Affiliation': 'Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ahalya', 'Initials': 'A', 'LastName': 'Malachira', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Mills', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Department of Infection, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Poole', 'Affiliation': 'Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031674'] 734,31857893,A study protocol for a randomised crossover study evaluating the effect of diets differing in carbohydrate quality on ileal content and appetite regulation in healthy humans.,"Introduction: A major component of the digesta reaching the colon from the distal ileum is carbohydrate. This carbohydrate is subject to microbial fermentation and can radically change bacterial populations in the colon and the metabolites they produce, particularly short-chain fatty acids (SCFA). However, very little is currently known about the forms and levels of carbohydrate in the ileum and the composition of the ileal microbiota in humans. Most of our current understanding of carbohydrate that is not absorbed by the small intestine comes from ileostomy models, which may not reflect the physiology of an intact gastrointestinal tract. Methods: We will investigate how ileal content changes depending on diet using a randomised crossover study in healthy humans. Participants will be inpatients at the research facility for three separate 4-day visits. During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending). On day 1, a nasoenteric tube will be placed into the distal ileum and its position confirmed under fluoroscopy. Ileal samples will be collected via the nasoenteric tube and metabolically profiled, which will determine the amount and type of carbohydrate present, and the composition of the ileal microbiota will be measured. Blood samples will be collected to assess circulating hormones and metabolites. Stool samples will be collected to assess faecal microbiota composition. Subjective appetite measures will be collected using visual analogue scales. Breath hydrogen will be measured in real-time as a marker of intestinal fermentation. Finally, an in vitro continuous fermentation model will be inoculated with ileal fluid in order to understand the shift in microbial composition and SCFA produced in the colon following the different diets. Registration: ISRCTN11327221.",2019,"During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending).",['healthy humans'],['diets differing in carbohydrate quality'],"['faecal microbiota composition', 'Subjective appetite measures']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0406295,"During each visit, participants will consume one of three diets, which differ in carbohydrate quality: 1) low-fibre refined diet; 2) high-fibre diet with intact cellular structures; 3) high-fibre diet where the cellular structures have been disrupted (e.g. milling, blending).","[{'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Byrne', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Blunt', 'Affiliation': 'Department of Imaging, Charing Cross Hospital, Imperial NHS Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': 'Department of Imaging, Charing Cross Hospital, Imperial NHS Trust, London, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chambers', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Aygul', 'Initials': 'A', 'LastName': 'Dagbasi', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Franco Becker', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Gibson', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mendoza', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Poveda', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Ramgulam', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Tashkova', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Walton', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Washirasaksiri', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Frost', 'Affiliation': 'Section for Nutrition Research, Department of Medicine, Imperial College London, London, UK.'}]",F1000Research,['10.12688/f1000research.17870.2'] 735,30630702,Two Interventions for PatientsWith Major Depression and Severe Chronic Obstructive Pulmonary Disease: Impact on Quality of Life.,"OBJECTIVE Clinically significant depression occurs in approximately 40% of chronic obstructive pulmonary disease (COPD) patients, and both illnesses severely impair quality of life. This study tests the hypothesis that problem-solving integrated with a treatment adherence intervention, the Problem Solving-Adherence (PSA), is superior to a personalized treatment adherence intervention, the Personalized Intervention for Depressed Patients with COPD (PID-C), alone in improving quality of life in depressed COPD patients. METHODS After screening 633 admissions for acute rehabilitation, we studied quality of life in 87 participants with major depression (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) and severe COPD randomly assigned to 14 sessions of PID-C or PSA over 26 weeks. Quality of life was assessed using the Word Health Organization Quality of Life-BREF at baseline and weeks 10, 14, and 26. RESULTS The hypothesis was not supported. Exploratory latent class growth modeling identified two quality of life trajectories. In 80.5% of participants, quality of life remained unchanged and improved in the remaining 19.5% during the first 14 weeks. Patients with a stable quality trajectory had higher qualityof life at baseline and a stronger sense of personal agency. CONCLUSION Maintaining quality of life is a favorable outcome in depressed patients with COPD whose course is one of deterioration. These findings highlight the usefulness of PID-C, an easy to learn, personalized adherence enhancement intervention that, after further testing, may be integrated into the rehabilitation and care of depressed COPD patients.",2019,"In 80.5% of participants, quality of life remained unchanged and improved in the remaining 19.5% during the first 14 weeks.","['depressed COPD patients', 'Depressed Patients with COPD (PID-C', 'chronic obstructive pulmonary disease (COPD) patients', 'depressed patients with COPD', '87 participants with major depression (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) and severe COPD randomly assigned to 14 sessions of PID-C or PSA over 26 weeks']",[],"['qualityof life', 'Quality of life', 'Word Health Organization Quality of Life-BREF', 'quality of life', 'Maintaining quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",87.0,0.038364,"In 80.5% of participants, quality of life remained unchanged and improved in the remaining 19.5% during the first 14 weeks.","[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Jackson', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY; and the Weill Cornell Department of Healthcare Policy and Research (SB, YW), White Plains, NY.'}, {'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pollari', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY.'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Novitch', 'Affiliation': 'Burke Rehabilitation Hospital (RN), White Plains, NY.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chalfin', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY.'}, {'ForeName': 'Yiyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'and the Weill Cornell Department of Healthcare Policy and Research (SB, YW), White Plains, NY.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry (DSJ, SB, JAS, CP, NS, AC, GSA), White Plains, NY. Electronic address: gsalexop@med.cornell.edu.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2018.12.004'] 736,31848169,"Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial.","INTRODUCTION Few treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE. METHODS AND ANALYSIS BEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. Patients with SLE commencing a treatment cycle of rituximab (two 1g infusions, 2 weeks apart) as standard of care will be randomised to receive belimumab or placebo, 4 to 8 weeks following the first rituximab infusion. Belimumab or placebo infusions are administered for 52 weeks. The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. Secondary outcomes include measures of adverse events, lupus disease activity and cumulative steroid dose. The kinetics of B cell repopulation will be assessed in a subgroup of participants. Belimumab administration after rituximab may provide a novel therapeutic pathway for patients with active lupus if safety is demonstrated in this proof of concept study, and lower anti-dsDNA antibodies levels are achieved in those patients treated with belimumab compared with placebo. ETHICS AND DISSEMINATION The protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available at https://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences. TRIAL REGISTRATION NUMBER ISRCTN47873; date assigned to the registry: 28 November 2016. The stage is pre-results.",2019,"Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse.","['Patients with SLE commencing a treatment cycle of', 'patients with systemic lupus erythematosus (BEAT Lupus) protocol', '28 November 2016', 'patients with systemic lupus erythematosus (SLE) who fail conventional therapy', 'patients with SLE', 'patients with active lupus']","['belimumab', 'Belimumab or placebo', 'placebo', 'belimumab following rituximab', 'rituximab', 'Belimumab after B cell depletion therapy', 'belimumab or placebo']","['measures of adverse events, lupus disease activity and cumulative steroid dose', 'anti-double stranded DNA (anti-dsDNA) antibody levels', 'safety and efficacy', 'kinetics of B cell repopulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1171324', 'cui_str': 'B-cell depletion therapy'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0311474', 'cui_str': 'DNA, Double-Stranded'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}]",,0.731757,"Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse.","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Centre for Rheumatology, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Muller', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Dore', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Ikeji', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Caverly', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Isenberg', 'Affiliation': 'Centre for Rheumatology, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'Rheumatology Research Team - Inflammation and Ageing (IIA), University of Birmingham Research Laboratories, New Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Ehrenstein', 'Affiliation': 'Centre for Rheumatology, Division of Medicine, University College London, London, UK m.ehrenstein@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-032569'] 737,31751317,Microbial functional change is linked with clinical outcomes after capsular fecal transplant in cirrhosis.,"BACKGROUNDHepatic encephalopathy (HE) is associated with poor outcomes. A prior randomized, pilot trial demonstrated safety after oral capsular fecal microbial transplant (FMT) in HE, with favorable changes in microbial composition and cognition. However, microbial functional changes are unclear. The aim of this study was to determine the effect of FMT on the gut-brain axis compared with placebo, using microbial function based on bile acids (BAs), inflammation (serum IL-6, LPS-binding protein [LBP]), and their association with EncephalApp.METHODSTwenty cirrhotic patients were randomized 1:1 into groups that received 1-time FMT capsules from a donor enriched in Lachnospiraceae and Ruminococcaceae or placebo capsules, with 5-month follow-up for safety outcomes. Stool microbiota and BA; serum IL-6, BA, and LBP; and EncephalApp were analyzed at baseline and 4 weeks after FMT/placebo. Correlation networks among microbiota, BAs, EncephalApp, IL-6, and LBP were performed before/after FMT.RESULTSFMT-assigned participants had 1 HE recurrence and 2 unrelated infections. Six placebo-assigned participants developed negative outcomes. FMT, but not placebo, was associated with reduced serum IL-6 and LBP and improved EncephalApp. FMT-assigned participants demonstrated higher deconjugation and secondary BA formation in feces and serum compared with baseline. No change was seen in placebo. Correlation networks showed greater complexity after FMT compared with baseline. Beneficial taxa, such as Ruminococcaceae, Verrucomicrobiaceae, and Lachnospiraceae, were correlated with cognitive improvement and decrease in inflammation after FMT. Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes.CONCLUSIONGut microbial function in cirrhosis is beneficially affected by capsular FMT, with improved inflammation and cognition. Lower secondary BAs in FMT recipients could select for participants who develop negative outcomes.TRIAL REGISTRATIONClinicaltrials.gov NCT03152188.FUNDINGNational Center for Advancing Translational Sciences NIH grant R21TR002024, VA Merit Review grant 2I0CX001076, the United Kingdom National Institute for Health Research Biomedical Facility at Imperial College London, the British Heart Foundation, Wellcome Trust, and King's College London.",2019,"Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes. ","['20 cirrhotic patients', 'Capsular Fecal Transplant in Cirrhosis']","['Six placebo', 'placebo', 'receiving one-time FMT capsules from a donor enriched in Lachnospiraceae and Ruminococcaceae, or placebo', 'oral capsular FMT', 'FMT']","['Stool microbiota and BA, serum IL-6, BA and LBP, and EncephalApp', 'HE recurrence', 'Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways', 'serum IL-6 and LBP and improved EncephalApp', 'Correlation networks between microbiota, BAs, EncephalApp, IL-6 and LBP', 'higher deconjugation and secondary BA formation', 'negative outcomes', 'bile acids (BA), inflammation (serum IL-6, lipopolysaccharide-binding protein,LBP), and EncephalApp', 'microbial composition and cognition']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.277157,"Fecal/serum secondary/primary ratios and PiCRUST secondary BA pathways did not increase in participants who developed poor outcomes. ","[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Salzman', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Takei', 'Affiliation': 'Junshin Clinic Bile Acid Institute, Meguro-Ku, Tokyo, Japan.'}, {'ForeName': 'Genta', 'Initials': 'G', 'LastName': 'Kakiyama', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Gavis', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Holtz', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nittono', 'Affiliation': 'Junshin Clinic Bile Acid Institute, Meguro-Ku, Tokyo, Japan.'}, {'ForeName': 'Phillip B', 'Initials': 'PB', 'LastName': 'Hylemon', 'Affiliation': 'Department of Microbiology and Immunology, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'I Jane', 'Initials': 'IJ', 'LastName': 'Cox', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Taylor-Robinson', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Matherly', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Puri', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Stravitz', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Ajayi', 'Affiliation': 'Institute for Hepatology London, Foundation for Liver Research, London, United Kingdom.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Le Guennec', 'Affiliation': ""Randall Centre for Cell & Molecular Biophysics and Centre for Biomolecular Spectroscopy, King's College London, London, United Kingdom.""}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Atkinson', 'Affiliation': ""Randall Centre for Cell & Molecular Biophysics and Centre for Biomolecular Spectroscopy, King's College London, London, United Kingdom.""}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Velimir', 'Initials': 'V', 'LastName': 'Luketic', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Pandak', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, Virginia, USA.'}]",JCI insight,['10.1172/jci.insight.133410'] 738,31754962,"Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study.","BACKGROUND LATITUDE was the first phase 3 trial examining the survival benefit of adding abiraterone acetate (AA) + prednisone (P) to androgen-deprivation therapy (ADT) in newly diagnosed metastatic, castration-sensitive prostate cancer (mCSPC). Due to significant improvement in overall survival after the first interim analysis, patients in the placebos + ADT arm could switch to AA + P + ADT during an open-label extension. As in other studies where switching is allowed, statistical adjustments are needed to assess the real benefit of new drugs. PATIENTS AND METHODS This was a post hoc analysis to estimate the true survival benefit of AA + P + ADT in patients with newly diagnosed mCSPC by applying statistical adjustments commonly used to adjust for treatment switching. RESULTS Of 112 patients still receiving placebos + ADT at the first interim analysis, 72 switched to AA + P + ADT during the open-label extension. Final analysis was conducted after median follow-up of 51.8 months. Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights. CONCLUSIONS Analyses adjusting for treatment switching using two different statistical approaches confirm the improved survival benefit of adding AA + P to ADT in patients with newly diagnosed mCSPC. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT01715285.",2019,"Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights. ","['112 patients still receiving', 'patients with newly diagnosed mCSPC', 'newly diagnosed metastatic, castration-sensitive prostate cancer (mCSPC']","['AA\u2009+\u2009P\u2009+\u2009ADT', 'placebos\u2009+\u2009ADT', 'abiraterone acetate (AA)\u2009+\u2009prednisone (P) to androgen-deprivation therapy (ADT']","['risk of death', 'survival benefit', 'overall survival']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",112.0,0.296385,"Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights. ","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Urologic Oncology, Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Urologic Oncology, Centre Hospitalier de L'Université de Montréal/CRCHUM, Montréal, QC, Canada.""}, {'ForeName': 'Nolen Joy', 'Initials': 'NJ', 'LastName': 'Perualila', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium. NPeruali@its.jnj.com.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Van Sanden', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Diels', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, Beerse, Belgium.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Health Economics and Market Access EMEA, Janssen, High Wycombe, Buckinghamshire, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Clinical Oncology, Janssen Research & Development BE, Spring House, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, University of Paris Sud, Paris, France.'}]",Targeted oncology,['10.1007/s11523-019-00685-x'] 739,31504709,Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study.,"BACKGROUND Whole grain wheat (WGW) consumption is associated with health benefits in observational studies. However, WGW randomized controlled trial (RCT) studies show mixed effects. OBJECTIVES The health impact of WGW consumption was investigated by quantification of the body's resilience, which was defined as the ""ability to adapt to a standardized challenge."" METHODS A double-blind RCT was performed with overweight and obese (BMI: 25-35 kg/m2) men (n = 19) and postmenopausal women (n = 31) aged 45-70 y, with mildly elevated plasma total cholesterol (>5 mmol/L), who were randomly assigned to either 12-wk WGW (98 g/d) or refined wheat (RW). Before and after the intervention a standardized mixed-meal challenge was performed. Plasma samples were taken after overnight fasting and postprandially (30, 60, 120, and 240 min). Thirty-one biomarkers were quantified focusing on metabolism, liver, cardiovascular health, and inflammation. Linear mixed-models evaluated fasting compared with postprandial intervention effects. Health space models were used to evaluate intervention effects as composite markers representing resilience of inflammation, liver, and metabolism. RESULTS Postprandial biomarker changes related to liver showed decreased alanine aminotransferase by WGW (P = 0.03) and increased β-hydroxybutyrate (P = 0.001) response in RW. Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6 (P = 0.02), IL-8 (P = 0.007), and decreased IL-1B (P = 0.0002) in RW and decreased C-reactive protein (P < 0.0001), serum amyloid A (P < 0.0001), IL-8 (P = 0.02), and IL-10 (P < 0.0001) in WGW. Health space visualization demonstrated diminished inflammatory (P < 0.01) and liver resilience (P < 0.01) by RW, whereas liver resilience was rejuvenated by WGW (P < 0.05). CONCLUSIONS Twelve-week 98 g/d WGW consumption can promote liver and inflammatory resilience in overweight and obese subjects with mildly elevated plasma cholesterol. The health space approach appeared appropriate to evaluate intervention effects as composite markers. This trial was registered at www.clinicaltrials.gov as NCT02385149.",2019,"Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6","['Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study', 'overweight and obese subjects with mildly elevated plasma cholesterol', 'overweight and obese (BMI: 25-35 kg/m2) men (n\xa0=\xa019) and postmenopausal women (n\xa0=\xa031) aged 45-70 y, with mildly elevated plasma total cholesterol (>5 mmol/L']","['RCT', 'Whole Grain Wheat Consumption', 'Whole grain wheat (WGW) consumption']","['liver resilience', 'IL-6', 'IL-10', 'β-hydroxybutyrate', 'RW and decreased C-reactive protein', 'IL-1B', 'alanine aminotransferase by WGW', 'C-reactive protein', 'metabolism, liver, cardiovascular health, and inflammation', 'serum amyloid', 'IL-8']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",,0.317179,"Postprandial changes related to inflammation showed increased C-reactive protein (P = 0.001), IL-6","[{'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Esser', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schutte', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Marion G', 'Initials': 'MG', 'LastName': 'Priebe', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Medical Biomics, Groningen, Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Vonk', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Medical Biomics, Groningen, Netherlands.'}, {'ForeName': 'Willem J', 'Initials': 'WJ', 'LastName': 'van den Brink', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van der Kamp', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Johanna H M', 'Initials': 'JHM', 'LastName': 'Stroeve', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}, {'ForeName': 'Lydia A', 'Initials': 'LA', 'LastName': 'Afman', 'Affiliation': 'Wageningen University, Division of Human Nutrition, Wageningen, Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Zeist, Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxz177'] 740,31456562,Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT.,"BACKGROUND A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role. OBJECTIVE The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session. DESIGN This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies. SETTING This trial was based in 21 NHS physiotherapy departments. PARTICIPANTS The participants were people with symptomatic OVF. INTERVENTIONS Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT). MAIN OUTCOME MEASURES Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version. RESULTS A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference -0.23 points, 95% confidence interval (CI) -3.20 to 1.59 points; p  = 1.000; and TLS test, difference 5.77 seconds, 95% CI -4.85 to 20.46 seconds; p  = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI -1.76 to 2.93 points; p  = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds; p  = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events. CONCLUSIONS This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects. TRIAL REGISTRATION Current Controlled Trials ISRCTN49117867. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.",2019,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","['25,000 people in the UK have osteoporotic vertebral fracture (OVF', 'The participants were people with symptomatic OVF', '21 NHS physiotherapy departments', 'people with OVF compared with a single physiotherapy session', 'participants aged <\u200970 years', 'participants with OVFs', '613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years', '615 participants were enrolled, with 216, 203 and 196 randomised by a']","['manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT', 'Exercise therapy', 'Exercise or manual physiotherapy', 'computer-generated program to exercise therapy, manual therapy and a SSPT', 'manual therapy nor exercise therapy']","['confidence interval (CI', 'quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis - 41 items) and timed loaded standing (TLS) test', 'thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0034380'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0022823'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",615.0,0.18653,"Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Minns Lowe', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Muhammad K', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Noufaily', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Adhikari', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23440'] 741,31203245,"Social support, social network and salt-reduction behaviours in children: a substudy of the School-EduSalt trial.","OBJECTIVES Healthy behaviour changes, such as reducing salt intake, are important to prevent lifestyle-related diseases. Social environment is a major challenge to achieve such behaviours, but the explicit mechanisms remain largely unknown. We investigated whether social networks of children were associated with their behaviours to reduce salt intake. DESIGN An ancillary study of a school-based cluster randomised controlled trial to reduce salt intake in children and their families (School-EduSalt), in which salt intake of children was significantly reduced by 25%. SETTING 14 primary schools in urban Changzhi, northern China. PARTICIPANTS 603 children aged 10-12 years in the intervention arm. PRIMARY AND SECONDARY OUTCOME MEASURES We developed a score assessing salt-reduction behaviours (SRB score) of children based on self-administered questionnaires. The SRB score was validated by the changes in salt intake measured by 24-hour urine collection in a random sample of 135 children. A 1-unit increase in SRB score was associated with a 0.31 g/day greater reduction in salt intake during the trial (95% CI 0.06 to 0.57, p=0.016). RESULTS Children from families with more family members not supporting salt reduction had significantly lower SRB scores (p<0.0001). Children from a class with a smaller size and from a class with more friendship connections, as well as children having more friends within the class all showed higher SRB scores (all p<0.05). Children whose school teachers attended the intervention programme more frequently also had higher SRB scores (p=0.043). CONCLUSION Social networks were associated with the behaviours to reduce salt intake in children. Future salt-reduction programmes may benefit from strategies that actively engage families and teachers, and strategies that enhance interconnectivity among peers. TRIAL REGISTRATION NUMBER NCT01821144; post-results.",2019,"Children whose school teachers attended the intervention programme more frequently also had higher SRB scores (p=0.043). ","['children', 'children and their families (School-EduSalt', '14 primary schools in urban Changzhi, northern China', '603 children aged 10-12 years in the intervention arm']","['Social support, social network and salt-reduction behaviours']","['score assessing salt-reduction behaviours (SRB score', 'SRB scores', 'salt intake', 'SRB score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0037438'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",603.0,0.0451624,"Children whose school teachers attended the intervention programme more frequently also had higher SRB scores (p=0.043). ","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Peking University Health Science Centre, Department of Epidemiology and Biostatistics, Beijing, China.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Preventive Medicine, Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Child and Adolescent Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Institute of Child and Adolescent Health, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Wuxiang', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yunjian', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Probability and Statistics, Peking University School of Mathematical Sciences, Beijing, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Preventive Medicine, Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Health Science Centre, Department of Epidemiology and Biostatistics, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2018-028126'] 742,32068014,The effect of copper-oxide-treated soft and hard surfaces on the incidence of healthcare-associated infections: a two-phase study.,"BACKGROUND Copper-oxide-impregnated linens and hard surfaces within the hospital environment have emerged as a novel technology to reduce environmental contamination and thereby potentially reduce the risk of healthcare-associated infections (HCAIs). METHODS This was a two-phase study. Phase 1 was a prospective, cluster-randomized, cross-over clinical trial in which one pod (eight beds) of our general ICU (GICU) utilized copper-oxide-impregnated linens whereas the other pod (eight beds) used standard hospital linens. Phase 2 was a two-year before-after study, following the relocation of three ICUs into a new ICU tower in which all the hard surfaces were treated with copper oxide (in addition to copper-impregnated linens). HCAIs were recorded using the National Healthcare Safety Network definitions. FINDINGS A total of 1282 patients were enrolled in phase 1. There was no difference in the rate of HCAI between the patients who received standard compared with copper oxide linen. In phase 2 there was a significant reduction in the number of infections due to Clostridioides difficile (2.4 per 1000 vs 0.7 per 1000 patient-days; incidence rate ratio: 3.3; 95% confidence interval: 1.4-8.7; P = 0.002) but no difference in the rate of central-line-associated bloodstream infections nor of catheter-associated urinary tract infections. CONCLUSION Copper-oxide-impregnated linens alone had no effect on the rate of HCAI. Our data suggest that copper-oxide-treated hard surfaces reduced the rate of infections due to C. difficile; however, important confounders cannot be excluded.",2020,There was no difference in the rate of HCAI between the patients who received standard as compared to copper-oxide linen.,"['1282 patients were enrolled in the first phase of the study', 'one pod (8-beds) of our General ICU (GICU) utilized copper-oxide impregnated linens while the other pod (8-beds) used standard hospital linens']","['Copper-Oxide treated soft and hard surfaces', 'copper-oxide']","['rate of HCAI', 'number of infections due to Clostridium difficile', ""rate of central line associated blood stream infections (CLABSI) nor catheter associated urinary tract infections (CAUTI's""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0056603', 'cui_str': 'cuprous oxide'}, {'cui': 'C0023734', 'cui_str': 'Linens'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0056603', 'cui_str': 'cuprous oxide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0005768'}, {'cui': 'C0442540', 'cui_str': 'Streams'}, {'cui': 'C3838785', 'cui_str': 'Catheter-associated urinary tract infection'}]",1282.0,0.0588645,There was no difference in the rate of HCAI between the patients who received standard as compared to copper-oxide linen.,"[{'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Marik', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Eastern Virginia Medical School, Norfolk, VA, USA. Electronic address: marikpe@evms.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Division of Infectious Diseases, Eastern Virginia Medical School, Norfolk, VA, USA; Division of Infectious Diseases, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'King', 'Affiliation': 'Infection Prevention and Control Coordinator, Sentara Norfolk General Hospital, Norfolk, VA, USA.'}]",The Journal of hospital infection,['10.1016/j.jhin.2020.02.006'] 743,31898531,0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial.,"BACKGROUND Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA. METHODS This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA. The study was done in a tertiary care, teaching, and referral hospital in India in children (> 1 month-12 years) with DKA as defined by ISPAD. Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded. Sixty-six children were randomized to receive either Plasma-Lyte (n = 34) or 0.9% saline (n = 32). MAIN OUTCOMES Primary outcome was incidence of new or progressive AKI, defined as a composite outcome of change in creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels. The secondary outcomes were resolution of AKI, time to resolution of DKA (pH > 7.3, bicarbonate> 15 mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay. RESULTS Baseline characteristics were similar in both groups. The incidence of new or progressive AKI was similar in both [Plasma-Lyte 13 (38.2%) versus 0.9% saline 15 (46.9%); adjusted OR 1.22; 95% CI 0.43-3.43, p = 0.70]. The median (IQR) time to resolution of DKA in Plasma-Lyte-A and 0.9% saline were 14.5 (12 to 20) and 16 (8 to 20) h respectively. Time to resolution of AKI was similar in both [Plasma-Lyte 22.1 versus 0.9% saline 18.8 h (adjusted HR 1.72; 95% CI 0.83-3.57; p = 0.14)]. Length of hospital stay was also similar in both [Plasma-Lyte 9 (8 to 12) versus 0.9% saline 10 (8.25 to 11) days; p = 0.39]. CONCLUSIONS The incidence of new or progressive AKI and resolution of AKI were similar in both groups. Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay. TRIAL REGISTRATION Clinical trial registry of India, CTRI/2018/05/014042 (ctri.nic.in) (Retrospectively registered).",2020,"Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay. ","['tertiary care, teaching, and referral hospital in India in children (>\u20091\u2009month-12\u2009years) with DKA as defined by ISPAD', 'Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded', 'adults with septic shock', 'Sixty-six children', 'children with diabetic ketoacidosis (SPinK trial']","['saline versus Plasma-Lyte', 'saline with Plasma-Lyte-A', 'Plasma-Lyte (n\xa0=\u200934) or 0.9% saline']","['incidence of new or progressive AKI and resolution of AKI', 'RRT, mortality, and lengths of PICU and hospital stay', 'incidence of new or progressive AKI', 'median (IQR) time to resolution of DKA', 'Time to resolution of AKI', 'incidence of new or progressive AKI, defined as a composite outcome of change in\xa0creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels', 'Length of hospital stay', 'resolution of AKI, time to resolution of DKA (pH\u2009>\u20097.3, bicarbonate>\u200915\u2009mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0006114', 'cui_str': 'Cerebral Edema'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0035611', 'cui_str': 'Rifles'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C0428196', 'cui_str': 'Bicarbonate level - finding'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",66.0,0.73124,"Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay. ","[{'ForeName': 'Vijai', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Jayashree', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India. mjshree@hotmail.com.'}, {'ForeName': 'Karthi', 'Initials': 'K', 'LastName': 'Nallasamy', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Dayal', 'Affiliation': 'Division of Pediatric Endocrinology, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Rawat', 'Affiliation': 'Division of Pediatric Allergy & Immunology, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.'}]","Critical care (London, England)",['10.1186/s13054-019-2683-3'] 744,31900172,"The use of ultrasensitive quantitative-PCR to assess the impact of primaquine on asymptomatic relapse of Plasmodium vivax infections: a randomized, controlled trial in Lao PDR.","BACKGROUND Trials to assess the efficacy of the radical cure of Plasmodium vivax malaria with 8-aminoquinolines require that most post-treatment relapses are identified, but there is no consensus on the optimal duration of follow-up in either symptomatic or asymptomatic vivax malaria. The efficacy of a 14-day course of primaquine on the cumulative incidence of recurrent asymptomatic P. vivax infections detected by ultrasensitive quantitative PCR (uPCR) as a primary endpoint was assessed. METHODS A randomized, placebo-controlled, single-blind trial was conducted in four villages of the Lao PDR during 2016-2018 nested in a larger project evaluating mass drug administrations (MDA) with dihydroartemisinin-piperaquine (DP) and a single low-dose primaquine to clear Plasmodium falciparum infections. In the nested sub-study, eligible participants with mono- or mixed P. vivax infections detected by uPCR were randomized to receive either 14 days of primaquine (0.5 mg/kg/day) or placebo during the last round of MDA (round 3) through directly observed therapy. Participants were checked monthly for 12 months for parasitaemia using uPCR. The primary outcome was cumulative incidence of participants with at least one recurrent episode of P. vivax infection. RESULTS 20 G6PD-normal participants were randomized in each arm. 5 (29%) of 20 participants in the placebo arm experienced asymptomatic, recurrent P. vivax infections, resulting in a cumulative incidence at month 12 of 29%. None of the 20 participants in the intervention arm had recurrent infections (p = 0.047 Fisher's exact test). Participants with recurrent P. vivax infections were found to be parasitaemic for between one and five sequential monthly tests. The median time to recurrence of P. vivax parasitaemia was 178 days (range 62-243 days). CONCLUSIONS A 14-day course of primaquine in addition to a DP-MDA was safe, well-tolerated, and prevented recurrent asymptomatic P. vivax infections. Long follow-up for up to 12 months is required to capture all recurrences following the treatment of asymptomatic vivax infection. To eliminate all malarias in settings where P. vivax is endemic, a full-course of an 8-aminoquinolines should be added to MDA to eliminate all malarias. Trial registration This study was registered with ClinicalTrials.gov under NCT02802813 on 16th June 2016. https://clinicaltrials.gov/ct2/show/NCT02802813.",2020,None of the 20 participants in the intervention arm had recurrent infections (p = 0.047 Fisher's exact test).,"['eligible participants with mono- or mixed P. vivax infections detected by uPCR', '20 G6PD-normal participants', 'four villages of the Lao PDR during 2016-2018 nested in a larger project evaluating mass drug administrations (MDA) with dihydroartemisinin-piperaquine (DP) and a single low-dose primaquine to clear Plasmodium falciparum infections', 'Plasmodium vivax infections', 'Participants with recurrent P. vivax infections']","['primaquine', '8-aminoquinolines', 'ultrasensitive quantitative-PCR', 'placebo']","['recurrent infections', 'ultrasensitive quantitative PCR (uPCR', 'asymptomatic, recurrent P. vivax infections', 'median time to recurrence of P. vivax parasitaemia', 'cumulative incidence of participants with at least one recurrent episode of P. vivax infection', 'cumulative incidence', 'cumulative incidence of recurrent asymptomatic P. vivax infections']","[{'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0534702', 'cui_str': 'lanthanum oxide'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4505223', 'cui_str': 'Mass Drug Administration'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0658114', 'cui_str': '8-aminoquinoline'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443287', 'cui_str': 'Recurrent episode (qualifier value)'}]",2018.0,0.356924,None of the 20 participants in the intervention arm had recurrent infections (p = 0.047 Fisher's exact test).,"[{'ForeName': 'Koukeo', 'Initials': 'K', 'LastName': 'Phommasone', 'Affiliation': 'Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Leth', 'Affiliation': 'Department of Global Health, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Henriques', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tiengkham', 'Initials': 'T', 'LastName': 'Pongvongsa', 'Affiliation': 'Savannakhet Provincial Health Department, Savannakhet, Savannakhet Province, Lao PDR.'}, {'ForeName': 'Bipin', 'Initials': 'B', 'LastName': 'Adhikari', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Cholrawee', 'Initials': 'C', 'LastName': 'Promnarate', 'Affiliation': 'WWARN Asia Regional Centre, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pasathorn', 'Initials': 'P', 'LastName': 'Sirithiranont', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cobelens', 'Affiliation': 'Department of Global Health, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Newton', 'Affiliation': 'Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'von Seidlein', 'Affiliation': 'Mahidol Oxford Research Unit, Mahidol University, Bangkok, Thailand. lorenz@tropmedres.ac.'}, {'ForeName': 'Mayfong', 'Initials': 'M', 'LastName': 'Mayxay', 'Affiliation': 'Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.'}]",Malaria journal,['10.1186/s12936-019-3091-5'] 745,31843338,Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial.,"BACKGROUND BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer, demonstrated improvement of local control and bladder cancer-specific survival from the addition of concomitant 5-fluorouracil and mitomycin C to radiotherapy. OBJECTIVE To determine the impact of treatment on the health-related quality of life (HRQoL) of BC2001 participants. DESIGN, SETTING, AND PARTICIPANTS 458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder. INTERVENTION Patients were randomised to the chemotherapy comparison (radiotherapy, 178, or chemoradiotherapy, 182); and/or to the radiotherapy comparison (standard, 108, or reduced high-dose volume radiotherapy, 111). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Patients completed Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires at baseline, end of treatment (EoT), and 6, 12, 24, 36, 48, and 60 months after radiotherapy. The primary endpoint was change from baseline in the bladder cancer subscale (BLCS) at 12 months. RESULTS AND LIMITATIONS Data were available for 331 (92%) and 204 (93%) participants at baseline and for 192 (54%) and 114 (52%) at 12 months for the chemotherapy and radiotherapy comparisons, respectively. HRQoL declined at EoT (BLCS -5.06 [99% confidence interval: -6.12 to -4.00, p< 0.001]; overall FACT-B TOTAL score -8.22 [-10.76 to -5.68, p< 0.01]), recovering to baseline at 6 months and remaining similar to baseline subsequently. There was no significant difference between randomised groups at any time point. CONCLUSIONS Immediately following (chemo)radiotherapy, a significant proportion of patients report declines in HRQoL, which improve to baseline after 6 months. Two-thirds of patients report stable or improved HRQoL on long-term follow-up. There is no evidence of impairment in HRQoL resulting from the addition of chemotherapy. PATIENT SUMMARY Quality of life of bladder cancer patients treated with radiotherapy±chemotherapy deteriorates during treatment, but improves to at least pretreatment levels within 6 months. Addition of chemotherapy to radiotherapy does not affect patient-reported quality of life.",2020,"There was no significant difference between randomised groups at any time point. ","['458 UK patients with T2-T4a N0 M0 transitional cell carcinoma of the bladder', 'muscle-invasive bladder cancer', 'Patients Treated for Muscle-invasive Bladder Cancer with', 'bladder cancer patients treated with', ' 178, or chemoradiotherapy, 182']","['bladder-sparing treatment', 'chemotherapy to radiotherapy', 'radiotherapy±chemotherapy deteriorates', 'Radiotherapy ± Chemotherapy', '5-fluorouracil and mitomycin C to radiotherapy', 'chemotherapy comparison (radiotherapy']","['bladder cancer subscale (BLCS', 'Quality of Life Outcomes', 'Quality of life', 'HRQoL', 'local control and bladder cancer-specific survival', 'quality of life', 'Functional Assessment of Cancer Therapy-Bladder (FACT-BL) questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",458.0,0.462282,"There was no significant difference between randomised groups at any time point. ","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Huddart', 'Affiliation': 'The Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Robert.Huddart@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Crundwell', 'Affiliation': 'Royal Devon & Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Jenkins', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rawlings', 'Affiliation': 'Torbay and South Devon NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tremlett', 'Affiliation': 'Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Campani', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hendron', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Academic unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.11.001'] 746,31532358,Protocolised non-invasive compared with invasive weaning from mechanical ventilation for adults in intensive care: the Breathe RCT.,"BACKGROUND Invasive mechanical ventilation (IMV) is a life-saving intervention. Following resolution of the condition that necessitated IMV, a spontaneous breathing trial (SBT) is used to determine patient readiness for IMV discontinuation. In patients who fail one or more SBTs, there is uncertainty as to the optimum management strategy. OBJECTIVE To evaluate the clinical effectiveness and cost-effectiveness of using non-invasive ventilation (NIV) as an intermediate step in the protocolised weaning of patients from IMV. DESIGN Pragmatic, open-label, parallel-group randomised controlled trial, with cost-effectiveness analysis. SETTING A total of 51 critical care units across the UK. PARTICIPANTS Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT. INTERVENTIONS Control group (invasive weaning): patients continued to receive IMV with daily SBTs. A weaning protocol was used to wean pressure support based on the patient's condition. Intervention group (non-invasive weaning): patients were extubated to NIV. A weaning protocol was used to wean inspiratory positive airway pressure, based on the patient's condition. MAIN OUTCOME MEASURES The primary outcome measure was time to liberation from ventilation. Secondary outcome measures included mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life. RESULTS A total of 364 patients (invasive weaning, n  = 182; non-invasive weaning, n  = 182) were randomised. Groups were well matched at baseline. There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p  = 0.352}. There was also no difference in mortality between groups at any time point. Patients in the non-invasive weaning group had fewer IMV days [invasive weaning 4 days (IQR 2-11 days) vs. non-invasive weaning 1 day (IQR 0-7 days); adjusted mean difference -3.1 days, 95% CI -5.75 to -0.51 days]. In addition, fewer non-invasive weaning patients required antibiotics for a respiratory infection [odds ratio (OR) 0.60, 95% CI 0.41 to 1.00; p  = 0.048]. A higher proportion of non-invasive weaning patients required reintubation than those in the invasive weaning group (OR 2.00, 95% CI 1.27 to 3.24). The within-trial economic evaluation showed that NIV was associated with a lower net cost and a higher net effect, and was dominant in health economic terms. The probability that NIV was cost-effective was estimated at 0.58 at a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. CONCLUSIONS A protocolised non-invasive weaning strategy did not reduce time to liberation from ventilation. However, patients who underwent non-invasive weaning had fewer days requiring IMV and required fewer antibiotics for respiratory infections. FUTURE WORK In patients who fail a SBT, which factors predict an adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV? TRIAL REGISTRATION Current Controlled Trials ISRCTN15635197. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 48. See the NIHR Journals Library website for further project information.",2019,"There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p  = ","['A total of 51 critical care units across the UK', 'Adult intensive care patients who had received IMV for at least 48 hours, who were categorised as ready to wean from ventilation, and who failed a SBT', 'patients from IMV', 'adults in intensive care', '364 patients (invasive weaning, n \u2009=\u2009182; non-invasive weaning, n \u2009=\u2009182']","['non-invasive ventilation (NIV', 'Control group (invasive weaning): patients continued to receive IMV with daily SBTs', 'Invasive mechanical ventilation (IMV', 'invasive weaning from mechanical ventilation']","['cost-effective', 'mortality', 'time to liberation from ventilation', 'IMV days [invasive weaning', 'mortality, duration of IMV, proportion of patients receiving antibiotics for a presumed respiratory infection and health-related quality of life', 'adverse outcome (reintubation, tracheostomy, death) if extubated and weaned using NIV', 'clinical effectiveness and cost-effectiveness', 'days requiring IMV']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085559'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",364.0,0.229172,"There was no difference between the invasive weaning and non-invasive weaning groups in median time to liberation from ventilation {invasive weaning 108 hours [interquartile range (IQR) 57-351 hours] vs. non-invasive weaning 104.3 hours [IQR 34.5-297 hours]; hazard ratio 1.1, 95% confidence interval [CI] 0.89 to 1.39; p  = ","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gao-Smith', 'Affiliation': 'Critical Care Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Snelson', 'Affiliation': 'Department of Critical Care, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, London, UK.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Camporota', 'Affiliation': ""Guy's and St Thomas' Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Varley', 'Affiliation': ""Department of Critical Care, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK.""}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Carle', 'Affiliation': 'Department of Critical Care, Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'Elankumaran', 'Initials': 'E', 'LastName': 'Paramasivam', 'Affiliation': 'Department of Critical Care, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Hoddell', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Paeztron', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sukhdeep', 'Initials': 'S', 'LastName': 'Dosanjh', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blair', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McAuley', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Centre for Experimental Medicine Institute for Health Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Medical Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Anaesthesia, Critical Care and Pain Medicine, Division of Health Sciences, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Centre for Experimental Medicine Institute for Health Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Faculty of Nursing, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Maredza', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23480'] 747,30352007,Randomized dose-escalation designs for drug combination cancer trials with immunotherapy.,"This work considers Phase I cancer dual-agent dose-escalation clinical trials in which one of the compounds is an immunotherapy. The distinguishing feature of trials considered is that the dose of one agent, referred to as a standard of care, is fixed and another agent is dose-escalated. Conventionally, the goal of a Phase I trial is to find the maximum tolerated combination (MTC). However, in trials involving an immunotherapy, it is also essential to test whether a difference in toxicities associated with the MTC and the standard of care alone is present. This information can give useful insights about the interaction of the compounds and can provide a quantification of the additional toxicity burden and therapeutic index. We show that both, testing for difference between toxicity risks and selecting MTC can be achieved using a Bayesian model-based dose-escalation design with two modifications. Firstly, the standard of care administrated alone is included in the trial as a control arm and each patient is randomized between the control arm and one of the combinations selected by a model-based design. Secondly, a flexible model is used to allow for toxicities at the MTC and the control arm to be modeled directly. We compare the performance of two-parameter and four-parameter logistic models with and without randomization to a current standard of such trials: a one-parameter model. It is found that at the cost of a small reduction in the proportion of correct selections in some scenarios, randomization provides a significant improvement in the ability to test for a difference in the toxicity risks. It also allows a better fitting of the combination-toxicity curve that leads to more reliable recommendations of the combination(s) to be studied in subsequent phases.",2019,"It is found that at the cost of a small reduction in the proportion of correct selections in some scenarios, randomization provides a significant improvement in the ability to test for a difference in the toxicity risks.",[],['immunotherapy'],"['toxicities', 'toxicity risks']",[],"[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0437214,"It is found that at the cost of a small reduction in the proportion of correct selections in some scenarios, randomization provides a significant improvement in the ability to test for a difference in the toxicity risks.","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Mozgunov', 'Affiliation': 'a Department of Mathematics and Statistics , Bailrigg, Lancaster , Lancaster University , UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'a Department of Mathematics and Statistics , Bailrigg, Lancaster , Lancaster University , UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Paoletti', 'Affiliation': ""b Service de Biostatistique et d'Epidémiologie & CESP OncoStat, INSERM , Institut Gustave Roussy, Université Paris-11 , Villejuif , France.""}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2018.1535503'] 748,31373374,"PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial.","BACKGROUND Food-assisted maternal and child health and nutrition (FA-MCHN) programs are widely used to reduce household food insecurity and maternal and child undernutrition in low- and middle-income countries. These programs, however, may unintentionally lead to excessive energy intake and unhealthy weight gain, especially in food-secure populations. OBJECTIVE We evaluated the impact of an FA-MCHN program implemented in Guatemala on maternal weight from pregnancy to 24 mo postpartum. The program was earlier shown to reduce stunting. METHODS We used a longitudinal, cluster-randomized controlled trial with arms varying in family ration size [full (FFR), reduced (RFR), none (NFR)] and individual maternal ration type [corn-soy blend (CSB), lipid-based nutrient supplement (LNS), micronutrient powder (MNP)]: A: FFR + CSB; B: RFR + CSB; C: NFR + CSB; D: FFR + LNS; E: FFR + MNP; F: control. Weight was measured during pregnancy and at 1, 4, 6, 9, 12, 18, and 24 mo postpartum. We used linear mixed models controlling for pregnancy weight with random cluster and mother effects. Data on 3535 women were analyzed. RESULTS Significant (P < 0.05) or marginally significant (P < 0.10) effects of 0.50-0.65 kg were found at all time points (except 9 mo) in arm A. Similar-sized effects were found in arms B (1, 4, 6, and 12 mo) and C (1 and 12 mo). Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo. CONCLUSIONS The effect on maternal postpartum weight is of concern because of the high existing prevalence of overweight. Programs need to include ""double-duty"" objectives and actions, to ensure that addressing child undernutrition does not exacerbate the problem of unhealthy weight gain. This trial was registered at clinicaltrials.gov as NCT01072279.",2019,"Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo. ","['Guatemala on maternal weight from pregnancy to 24 mo postpartum', 'Guatemala', '3535 women were analyzed']","['individual maternal ration type [corn-soy blend (CSB), lipid-based nutrient supplement (LNS), micronutrient powder (MNP', 'FA-MCHN program', 'Food-assisted maternal and child health and nutrition (FA-MCHN']","['Weight', 'family ration size [full (FFR), reduced (RFR), none (NFR']","[{'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1264664', 'cui_str': 'Number fraction'}]",3535.0,0.100416,"Marginally significant effects (0.51-0.66 kg) were found in arm D (1, 6, 9, and 12 mo); in arm E, marginally significant effects (0.48-0.75 kg) were found from 6 to 24 mo. ","[{'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Ruel', 'Affiliation': 'Poverty, Health and Nutrition, International Food Policy Research Institute, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz175'] 749,31779689,Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.,"BACKGROUND Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION ISRCTN registry, ISRCTN59404712. Registered 28/11/17.",2019,"This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. ","['Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking', 'Eligible participants', 'hardcore smokers with smoking-related chronic disease', 'smokers with smoking-related chronic diseases or SMI', 'smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking']","['general practitioner and nurse promotion of electronic cigarettes versus standard care', 'general practitioners (GPs) and nurses delivering a brief advice intervention', 'control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials']","['patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention', 'smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months', 'smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence', 'feasibility, acceptability and effectiveness']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4505216', 'cui_str': 'Vaper'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0242800', 'cui_str': 'Patient Recruitment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0726383,"This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. ","[{'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK. rachna.begh@phc.ox.ac.uk.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Coleman', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Academic Unit of Psychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Barnes', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, NR4 7UL, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Gilbert', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, Royal Free and University College Medical School, London, NW3 2PF, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ferrey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Madigan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Hamilton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Warren', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Grabey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dickinson', 'Affiliation': ""Division of Primary Care, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-019-3850-1'] 750,31806610,NINJA trial: should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multicentre randomised control trial.,"INTRODUCTION Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children. METHODS AND ANALYSIS A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance. ETHICS AND DISSEMINATION The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair. TRIAL REGISTRATION NUMBER ISRCTN44551796.",2019,The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery.,"['416 patients (208 in each group) over 3 years', '4 June 2019 (18/SC/0024', 'children presenting within 48\u2009hours of a nail bed injury requiring surgical repair']","['nail plate or not, as part of a nail bed repair']","['EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use', 'cosmetic appearance summary score at a minimum of 4 months and surgical site infection', 'postoperative infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1735595', 'cui_str': 'Nail bed injury'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0221997', 'cui_str': 'Nail bed structure'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}]",416.0,0.139695,The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery.,"[{'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Plastic Surgery, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Gardiner', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom matthew.gardiner@kennedy.ox.ac.uk.'}, {'ForeName': 'Cushla', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sierakowski', 'Affiliation': ""St Andrew's Centre for Plastic Surgery and Burns, Mid Essex Hospital Services NHS Trust, Chelmsford, United Kingdom.""}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Stokes', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Shirkey', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Aina V H', 'Initials': 'AVH', 'LastName': 'Greig', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}]",BMJ open,['10.1136/bmjopen-2019-031552'] 751,31775518,Physical Activity as a Predictor of Clinical Trial Outcomes in Bipolar Depression: A Subanalysis of a Mitochondrial-Enhancing Nutraceutical Randomized Controlled Trial.,"OBJECTIVES Individuals with bipolar disorder (BD) generally engage in low levels of physical activity (PA), and yet few studies have investigated the relationship between PA and change in BD symptom severity. The aim of this subanalysis of an adjunctive nutraceutical randomized controlled trial for the treatment of bipolar depression was to explore the relationship between PA, the active adjunctive treatments (a nutraceutical ""mitochondrial cocktail""), and clinical outcomes. METHODS Participants with bipolar depression were randomized to receive N -acetylcysteine alone, N -acetylcysteine with a combination of nutraceuticals (chosen for the potential to increase mitochondrial activity), or placebo for 16 weeks. Participants ( n = 145) who completed the International Physical Activity Questionnaire-Short Form (IPAQ-SF; measured at Week 4) were included in this exploratory subanalysis. Assessments of BD symptoms, functioning, and quality of life were completed at monthly visits up until Week 20. Generalised Estimating Equations were used to explore whether IPAQ-SF scores were a moderator of treatment received on outcomes of the study. RESULTS Week-4 PA was not related to changes in Montgomery Åsberg Depression Rating Scale scores across the study until Week 20. However, participants who engaged in more PA and who received the combination treatment were more likely to have a reduction in scores on the Bipolar Depression Rating Scale ( P = 0.03). However, this was not consistent in all domains explored using the IPAQ-SF. Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment. CONCLUSIONS This study provides novel evidence of the association between PA and reduction in BD symptoms in a nutraceutical clinical trial. However, further research assessing the potential synergistic effects of PA in BD is required.",2020,"Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment. ","['Participants ( n = 145) who completed the International Physical Activity Questionnaire-Short Form (IPAQ-SF; measured at Week 4) were included in this exploratory subanalysis', 'Bipolar Depression', 'Individuals with bipolar disorder (BD', 'Participants with bipolar depression']","['N -acetylcysteine alone, N -acetylcysteine with a combination of nutraceuticals (chosen for the potential to increase mitochondrial activity), or placebo']","['Montgomery Åsberg Depression Rating Scale scores', 'social and occupational functioning', 'quality of life', 'Assessments of BD symptoms, functioning, and quality of life', 'IPAQ-SF scores', 'Bipolar Depression Rating Scale']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0222045'}]",,0.129464,"Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment. ","[{'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Ashton', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Gin S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'Academic Department of Psychiatry, Northern Sydney Local Health District, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Chee H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Richmond, Victoria, Australia.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Centre of Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Seetal', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Richmond, Victoria, Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Hopwood', 'Affiliation': 'Professorial Psychiatry Unit, Albert Road Clinic, Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': 'Physiotherapy Department, South London and Maudsley NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'IMPACT Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, Australia.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719889547'] 752,31393176,Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.,"Background: The G lycemia R eduction A pproaches in D iabetes: A Comparative E ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. Methods: The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. Conclusions: The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.",2019,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. ","['Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other', 'patients of different races or ethnicities', 'enrolled a racially and ethnically diverse population with type 2 diabetes', '1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared']",['CGM'],"['R eduction', 'average glucose (AG) and hemoglobin A1c (HbA1c']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",450.0,0.0248676,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. ","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higgins', 'Affiliation': 'Department of Systems Biology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tiktin', 'Affiliation': 'Multidisciplinary Research, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Cincinnati VA Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arends', 'Affiliation': 'Advanced Research and Diagnostic Laboratory, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0202'] 753,31345462,"Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial.","BACKGROUND Identifying new antifungals for cryptococcal meningitis is a priority given the inadequacy of current therapy. Sertraline has previously shown in vitro and in vivo activity against cryptococcus. We aimed to assess the efficacy and cost-effectiveness of adjunctive sertraline in adults with HIV-associated cryptococcal meningitis compared with placebo. METHODS In this double-blind, randomised, placebo-controlled trial, we recruited HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda. Participants were randomly assigned (1:1) to receive standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole (starting at 800 mg/day) with either adjunctive sertraline or placebo. Sertraline was administered orally or via nasogastric tube at a dose of 400 mg/day for 2 weeks, followed by 200 mg/day for 12 weeks, then tapered off over 3 weeks. The primary endpoint was 18-week survival, analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT01802385. FINDINGS Between March 9, 2015, and May 29, 2017, we screened 842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility. Three patients in the sertraline group and three patients in the placebo group were lost to follow-up and therefore discontinued before study end. At 18 weeks, 120 (52%) of 229 patients in the sertraline group and 106 (46%) of 231 patients in the placebo group had died (hazard ratio 1·21, 95% CI 0·93-1·57; p=0·15). The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10 CFU/mL per day [95% CI 0·37-0·50] in the sertraline group vs 0·47 -log 10 CFU/mL per day [0·40-0·54] in the placebo group; p=0·59), as was occurrence of grade 4 or 5 adverse events (72 [31%] of 229 vs 75 [32%] of 231; p=0·98), most of which were associated with amphotericin B toxicity. INTERPRETATION Sertraline did not reduce mortality and should not be used to treat patients with HIV-associated cryptococcal meningitis. The reasons for sertraline inactivity appear to be multifactorial and might be associated with insufficient duration of therapeutic sertraline concentrations. FUNDING National Institutes of Health and Medical Research Council, Wellcome Trust.",2019,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10 CFU/mL per day,"['group vs 0·47 -log 10', 'adults with HIV-associated cryptococcal meningitis', 'HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda', 'HIV-associated cryptococcal meningitis', 'Between March 9, 2015, and May 29, 2017', '842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility', 'patients with HIV-associated cryptococcal meningitis']","['sertraline', 'adjunctive sertraline or placebo', 'standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole', 'Adjunctive sertraline', 'placebo', 'adjunctive sertraline', 'Sertraline']","['18-week survival, analysed by intention-to-treat', 'amphotericin B toxicity', 'efficacy and cost-effectiveness', 'fungal clearance rate from cerebrospinal fluid', 'occurrence of grade 4 or 5 adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0086322', 'cui_str': 'Futility'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",550.0,0.816271,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10 CFU/mL per day,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rhein', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda. Electronic address: joshua.rhein@gmail.com.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Huppler Hullsiek', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Tugume', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Nuwagira', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mpoza', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Kiggundu', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ssebambulidde', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Akampurira', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Abdu K', 'Initials': 'AK', 'LastName': 'Musubire', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda; School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30127-6'] 754,31573939,Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study).,"BACKGROUND Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. OBJECTIVE This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. METHODS This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. RESULTS Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were ""stuck"" at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. CONCLUSIONS The ARMADILLO study's implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. CLINICAL TRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148.",2019,"RESULTS Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu.","['youth (aged 15-24 years', '660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were ""stuck"" at the language menu', 'Kwale County, Kenya', 'eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam']",[],[],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0445519', 'cui_str': 'Kwale (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1292718', 'cui_str': 'Is a'}]",[],[],660.0,0.139368,"RESULTS Two study team decisions had significant implications for the success of the trial's enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu.","[{'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Gonsalves', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Winnie Wangari', 'Initials': 'WW', 'LastName': 'Njeri', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Ona, Nairobi, Kenya.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Mwaisaka', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gichangi', 'Affiliation': 'International Centre for Reproductive Health-Kenya, Mombasa, Kenya.'}]",JMIR mHealth and uHealth,['10.2196/13005'] 755,31378435,The Finnish Randomized Trial of Adjuvant Radiotherapy Versus Observation After Prostatectomy: Almost a Trial of Adjuvant Versus Late Salvage Radiotherapy.,,2019,,[],"['Adjuvant Radiotherapy Versus Observation', 'Adjuvant Versus Late Salvage Radiotherapy']",[],[],"[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0356717,,"[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. Electronic address: sprattda@med.umich.edu.'}]",European urology,['10.1016/j.eururo.2019.07.036'] 756,31651545,Predictors of Viremia in Postpartum Women on Antiretroviral Therapy.,"BACKGROUND HIV-infected, postpartum women on antiretroviral therapy (ART) have high rates of viremia. We examined predictors of postpartum viremia in the PROMISE study. METHODS Women with pre-ART CD4 T-cell counts ≥400 cells/mm who started ART during pregnancy were randomized postpartum to continue ART (CTART) or discontinue ART (DCART). Viral load and self-reported adherence were collected every 12 weeks, up to 144 weeks. Women in DCART reinitiated therapy when clinically indicated. Viremia was defined as 2 consecutive viral loads >1000 copies/mL after 24 weeks on ART. Adherence was dichotomized as missing versus not missing ART doses in the past 4 weeks. Predictors of viremia were examined using Cox proportional hazards regression with adherence as a time-varying covariate. RESULTS Among 802 women in the CTART arm, median age at entry was 27 years and median CD4 T-cell count 696 cells/mm. Of 175 women in CTART with viremia (22%), 141 had resistance data, and 12% had resistance to their current regimen. There was an estimated 0.12 probability of viremia by week 48 and 0.25 by week 144. Predictors of viremia included missed ART doses within the past 4 weeks, younger age, shorter duration of pre-entry ART, and being from the South American/Caribbean region. Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144). CONCLUSIONS Rates of postpartum viremia are high and viremia is more likely in younger postpartum women who start ART later in pregnancy. Interventions should target these higher-risk women.",2020,"Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144). ","['Postpartum Women on Antiretroviral Therapy', 'younger postpartum women who start ART later in pregnancy', 'Women with pre-ART CD4+ T-cell counts ≥400 cells/mm who started ART during pregnancy were randomized', '802 women in the CTART arm, median age at entry was 27 years and median CD4+ T-cell count 696 cells/mm ', '137 women in DCART who reinitiated therapy', 'HIV-infected, postpartum women on antiretroviral therapy (ART', '175 women in CTART with viremia (22']",['postpartum to continue (CTART) or discontinue treatment (DCART'],"['Viremia', 'probability of viremia', 'Adherence', 'Viral load and self-reported adherence']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",802.0,0.137621,"Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144). ","[{'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Meredith G', 'Initials': 'MG', 'LastName': 'Warshaw', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pilotto', 'Affiliation': 'JP, Fundação Oswaldo Cruz/IOC Laboratório de AIDS e Imunologia Molecular, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gaerolwe', 'Initials': 'G', 'LastName': 'Masheto', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Jullapong', 'Initials': 'J', 'LastName': 'Achalapong', 'Affiliation': 'Chiang Rai Prachanukroh Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Machado', 'Affiliation': 'Instituto de Puericultura e Pediatria Martagão Gesteira, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Duarte', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Esau', 'Initials': 'E', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Kathleen K', 'Initials': 'KK', 'LastName': 'Graham', 'Affiliation': ""Children's Diagnostic and Treatment Center, Fort Lauderdale, FL.""}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Knapp', 'Affiliation': ""Infectious Diseases Department, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Stek', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, University of Southern CaliforniaLos Angeles, CA.'}, {'ForeName': 'Gwendolyn B', 'Initials': 'GB', 'LastName': 'Scott', 'Affiliation': 'School of Medicine, University of Miami Miller, Miami, FL.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Loftis', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH, Bethesda, MD.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002228'] 757,30870563,Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial.,"Importance High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently. Objective To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes. Design, Setting, and Participants A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat. Interventions Tools, training, and system changes. Main Outcomes and Measures The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated. Results Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups. Conclusions and Relevance The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study. Trial Registration ClinicalTrials.gov identifier: NCT01786811.",2019,"Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31).","['Patients with advanced cancer (n\u2009=\u2009278) and oncology clinicians (n\u2009=\u200991) participated between September 1, 2012, and June 30, 2016', 'Outpatient Oncology']","['communication quality-improvement intervention (Serious Illness Care Program', 'Serious Illness Care Program']","['severe anxiety', 'Survival and therapeutic alliance', 'therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival', 'Peacefulness, therapeutic alliance, anxiety, and depression', 'depression symptoms', 'Anxiety reduction', 'anxiety and depression', 'goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire', 'depression reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic) (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",64.0,0.109751,"Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31).","[{'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0077'] 758,31063156,Keratinocyte growth factor impairs human thymic recovery from lymphopenia.,"BACKGROUND The lymphocyte-depleting antibody alemtuzumab is a highly effective treatment of relapsing-remitting multiple sclerosis (RRMS); however 50% of patients develop novel autoimmunity post-treatment. Most at risk are individuals who reconstitute their T-cell pool by proliferating residual cells, rather than producing new T-cells in the thymus; raising the possibility that autoimmunity might be prevented by increasing thymopoiesis. Keratinocyte growth factor (palifermin) promotes thymopoiesis in non-human primates. METHODS Following a dose-tolerability sub-study, individuals with RRMS (duration ≤10 years; expanded disability status scale ≤5·0; with ≥2 relapses in the previous 2 years) were randomised to placebo or 180mcg/kg/day palifermin, given for 3 days immediately prior to and after each cycle of alemtuzumab, with repeat doses at M1 and M3. The interim primary endpoint was naïve CD4+ T-cell count at M6. Exploratory endpoints included: number of recent thymic-emigrants (RTEs) and signal-joint T-cell receptor excision circles (sjTRECs)/mL of blood. The trial primary endpoint was incidence of autoimmunity at M30. FINDINGS At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment. No difference was observed in the rate of autoimmunity between the two groupsConclusion: In contrast to animal studies, palifermin reduced thymopoiesis in our patients. These results offer a note of caution to those using palifermin to promote thymopoiesis in other settings, particularly in the oncology/haematology setting where alemtuzumab is often used as part of the conditioning regime. TRIAL REGISTRATION ClinicalTrials.gov NCT01712945Funding: MRC and Moulton Charitable Foundation.",2019,"At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment.",['individuals with RRMS (duration ≤10 years; expanded disability status scale ≤5·0; with ≥2 relapses in the previous 2 years'],"['placebo or 180mcg/kg/day palifermin', 'Keratinocyte growth factor (palifermin', 'palifermin']","['incidence of autoimmunity at M30', 'rate of autoimmunity', 'naïve CD4+T-cells', 'number of recent thymic-emigrants (RTEs) and signal-joint T-cell receptor excision circles (sjTRECs)/mL of blood', 'naïve CD4+ T-cell count at M6']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0677829', 'cui_str': 'Palifermin'}, {'cui': 'C0064294', 'cui_str': 'Fibroblast Growth Factor 7'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1955873', 'cui_str': 'Emigrants'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0005768'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0385008,"At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment.","[{'ForeName': 'Alasdair J', 'Initials': 'AJ', 'LastName': 'Coles', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Azzopardi', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Onajite', 'Initials': 'O', 'LastName': 'Kousin-Ezewu', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Harpreet Kaur', 'Initials': 'HK', 'LastName': 'Mullay', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sara Aj', 'Initials': 'SA', 'LastName': 'Thompson', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Jarvis', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Howlett', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rainbow', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Babar', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Sadler', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'J William L', 'Initials': 'JWL', 'LastName': 'Brown', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Needham', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'May', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Zoya G', 'Initials': 'ZG', 'LastName': 'Georgieva', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Handel', 'Affiliation': 'Nuffield Department of Clinical Neurosciences and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Maio', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Deadman', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Rota', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Holländer', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawson', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Seggewiss-Bernhardt', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Douek', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Isaacs', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}]",JCI insight,['10.1172/jci.insight.125377'] 759,31661431,"Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA 2 five-stage study, including a workshop.","BACKGROUND The randomised controlled trial is widely considered to be the gold standard study for comparing the effectiveness of health interventions. Central to its design is a calculation of the number of participants needed (the sample size) for the trial. The sample size is typically calculated by specifying the magnitude of the difference in the primary outcome between the intervention effects for the population of interest. This difference is called the 'target difference' and should be appropriate for the principal estimand of interest and determined by the primary aim of the study. The target difference between treatments should be considered realistic and/or important by one or more key stakeholder groups. OBJECTIVE The objective of the report is to provide practical help on the choice of target difference used in the sample size calculation for a randomised controlled trial for researchers and funder representatives. METHODS The Difference ELicitation in TriAls 2 (DELTA 2 ) recommendations and advice were developed through a five-stage process, which included two literature reviews of existing funder guidance and recent methodological literature; a Delphi process to engage with a wider group of stakeholders; a 2-day workshop; and finalising the core document. RESULTS Advice is provided for definitive trials (Phase III/IV studies). Methods for choosing the target difference are reviewed. To aid those new to the topic, and to encourage better practice, 10 recommendations are made regarding choosing the target difference and undertaking a sample size calculation. Recommended reporting items for trial proposal, protocols and results papers under the conventional approach are also provided. Case studies reflecting different trial designs and covering different conditions are provided. Alternative trial designs and methods for choosing the sample size are also briefly considered. CONCLUSIONS Choosing an appropriate sample size is crucial if a study is to inform clinical practice. The number of patients recruited into the trial needs to be sufficient to answer the objectives; however, the number should not be higher than necessary to avoid unnecessary burden on patients and wasting precious resources. The choice of the target difference is a key part of this process under the conventional approach to sample size calculations. This document provides advice and recommendations to improve practice and reporting regarding this aspect of trial design. Future work could extend the work to address other less common approaches to the sample size calculations, particularly in terms of appropriate reporting items. FUNDING Funded by the Medical Research Council (MRC) UK and the National Institute for Health Research as part of the MRC-National Institute for Health Research Methodology Research programme.",2019,"The Difference ELicitation in TriAls 2 (DELTA 2 ) recommendations and advice were developed through a five-stage process, which included two literature reviews of existing funder guidance and recent methodological literature; a Delphi process to engage with a wider group of stakeholders; a 2-day workshop; and finalising the core document. ",[],[],[],[],[],[],,0.13543,"The Difference ELicitation in TriAls 2 (DELTA 2 ) recommendations and advice were developed through a five-stage process, which included two literature reviews of existing funder guidance and recent methodological literature; a Delphi process to engage with a wider group of stakeholders; a 2-day workshop; and finalising the core document. ","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Julious', 'Affiliation': 'Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sones', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Hampson', 'Affiliation': 'Statistical Methodology and Consulting, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Berlin', 'Affiliation': 'Johnson & Johnson, Titusville, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ashby', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Edward Cf', 'Initials': 'EC', 'LastName': 'Wilson', 'Affiliation': 'Cambridge Centre for Health Services Research, Cambridge Clinical Trials Unit University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Warwick Medical School, Statistics and Epidemiology, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Wessex Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Armstrong', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Luke D', 'Initials': 'LD', 'LastName': 'Vale', 'Affiliation': 'Health Economics Group, Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23600'] 760,30874716,Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial.,"Importance Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain. Objective To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF. Design, Setting, and Participants An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017. Interventions Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096). Main Outcomes and Measures Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points). Results Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). Conclusions and Relevance Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation. Trial Registration ClinicalTrials.gov Identifier: NCT00911508.",2019,"The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). Conclusions and Relevance Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months.","['patients with atrial fibrillation (AF', '2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke', 'Patients With Atrial Fibrillation', '2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial', 'patients with AF.\nDesign, Setting, and Participants', 'Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries']","['catheter ablation', 'Importance\n\n\nCatheter ablation', 'standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy', 'Catheter Ablation vs Medical Therapy', 'catheter ablation vs drug therapy']","['mean MAFSI frequency score', 'mean AFEQT summary score', 'Quality of Life', 'quality of life', 'mean MAFSI severity score', 'severity score', 'Main Outcomes and Measures\n\n\nPrespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",2204.0,0.170242,"The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). Conclusions and Relevance Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months.","[{'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Khaula N', 'Initials': 'KN', 'LastName': 'Baloch', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Daniels', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.0692'] 761,32113625,Optimal Design of Population-Level Financial Incentives of Influenza Vaccination for the Elderly.,"OBJECTIVES To identify how monetary incentives affect influenza vaccination uptake rate using a randomized control experiment and to subsequently design an optimal incentive program in Singapore, a high-income country with a market-based healthcare system. METHODS 4000 people aged ≥65 were randomly assigned to 4 treatment groups (1000 each) and were offered a monetary incentive (in shopping vouchers) if they chose to participate. The baseline group was invited to complete a questionnaire with incentives of 10 Singapore dollars (SGD; where 1 SGD ≈ 0.73 USD), whereas the other three groups were invited to complete the questionnaire and be vaccinated against influenza at their own cost of around 32 SGD, in return for incentives of 10, 20, or 30 SGD. RESULTS Increasing the total incentive for vaccination and reporting from 10 to 20 SGD increased participation in vaccination from 4.5% to 7.5% (P < .001). Increasing the total incentive from 20 to 30 SGD increased the participation rate to 9.2%, but this was not statistically significantly different from a 20-SGD incentive. The group of nonworking elderly were more sensitive to changes in incentives than those who worked. In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience. There were no significant differential effects by age group, gender, or education, however. The cost of the program per completed vaccination under a 20-SGD incentive is 36.80 SGD, which was the lowest among the three intervention arms. For a hypothetical population-level financial incentive program to promote influenza vaccination among the elderly, accounting for transmission dynamics, an incentive between 10 and 20 SGD minimizes the cost per completed vaccination from both governmental and health system perspectives. CONCLUSIONS Appropriate monetary incentives can boost influenza vaccination rates. Increasing monetary incentives for vaccination from 10 to 20 SGD can improve the influenza vaccination uptake rate, but further increasing the monetary incentive to 30 SGD results in no additional gains. A partial incentive may therefore be considered to improve vaccination coverage in this high-risk group.",2020,"In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience.","['4000 people aged ≥65', 'Singapore, a high-income country with a market-based healthcare system']",['monetary incentive (in shopping vouchers'],"['influenza vaccination uptake rate', 'vaccination coverage', 'influenza vaccination rates', 'participation rate']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0150768', 'cui_str': 'Shopping (observable entity)'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]",4000.0,0.0215498,"In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience.","[{'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Yue', 'Affiliation': 'School of Mathematical Sciences, University of Electronic Science and Technology of China, Chengdu, Sichuan, China; Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Chng Kiat', 'Initials': 'CK', 'LastName': 'Low', 'Affiliation': 'Department of Statistics and Applied Probability, National University of Singapore, Singapore.'}, {'ForeName': 'Joanne Su-Yin', 'Initials': 'JS', 'LastName': 'Yoong', 'Affiliation': 'Center for Economic and Social Research, University of Southern California, Los Angeles, CA, USA; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Cook', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore; Department of Statistics and Applied Probability, National University of Singapore, Singapore; Duke-NUS Medical School Singapore, Singapore. Electronic address: alex.richard.cook@gmail.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.08.006'] 762,31974286,"Sodium Bicarbonate Supplementation and Urinary TGF- β 1 in Nonacidotic Diabetic Kidney Disease: A Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES In early-phase studies of individuals with hypertensive CKD and normal serum total CO 2 , sodium bicarbonate reduced urinary TGF- β 1 levels and preserved kidney function. The effect of sodium bicarbonate on kidney fibrosis and injury markers in individuals with diabetic kidney disease and normal serum total CO 2 is unknown. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We conducted a randomized, double-blinded, placebo-controlled study in 74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, and serum total CO 2 of 22-28 meq/L. Participants received oral sodium bicarbonate (0.5 meq/kg lean body wt per day; n =35) or placebo ( n =39) for 6 months. The primary outcome was change in urinary TGF- β 1-to-creatinine from baseline to months 3 and 6. Secondary outcomes included changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR from baseline to months 3 and 6. RESULTS Key baseline characteristics were age 72±8 years, eGFR of 51±18 ml/min per 1.73 m 2 , and serum total CO 2 of 24±2 meq/L. Sodium bicarbonate treatment increased mean total CO 2 by 1.2 (95% confidence interval [95% CI], 0.3 to 2.1) meq/L, increased urinary pH by 0.6 (95% CI, 0.5 to 0.8), and decreased urinary ammonium excretion by 5 (95% CI, 0 to 11) meq/d and urinary titratable acid excretion by 11 (95% CI, 5 to 18) meq/d. Sodium bicarbonate did not significantly change urinary TGF- β 1/creatinine (difference in change, 13%, 95% CI, -10% to 40%; change within the sodium bicarbonate group, 8%, 95% CI, -10% to 28%; change within the placebo group, -4%, 95% CI, -19% to 13%). Similarly, no significant effect on KIM-1-to-creatinine (difference in change, -10%, 95% CI, -38% to 31%), fibronectin-to-creatinine (8%, 95% CI, -15% to 37%), NGAL-to-creatinine (-33%, 95% CI, -56% to 4%), or UACR (1%, 95% CI, -25% to 36%) was observed. CONCLUSIONS In nonacidotic diabetic kidney disease, sodium bicarbonate did not significantly reduce urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR over 6 months.",2020,Sodium bicarbonate did not significantly change urinary,"['74 United States veterans with type 1 or 2 diabetes mellitus, eGFR of 15-89 ml/min per 1.73 m 2 , urinary albumin-to-creatinine ratio (UACR) ≥30', 'individuals with hypertensive CKD and normal serum total CO 2 ', 'Nonacidotic Diabetic Kidney Disease', 'individuals with diabetic kidney disease and normal serum total CO 2']","['sodium bicarbonate', 'Sodium Bicarbonate Supplementation and Urinary TGF', 'oral sodium bicarbonate', 'placebo', 'Sodium bicarbonate', 'TGF']","['urinary pH', 'fibronectin-to-creatinine', 'urinary ammonium excretion', 'KIM-1-to-creatinine', 'NGAL-to-creatinine', 'change urinary', 'urinary titratable acid excretion', 'UACR', 'kidney fibrosis and injury markers', 'changes in urinary kidney injury molecule-1 (KIM-1)-to-creatinine, fibronectin-to-creatinine, neutrophil gelatinase-associated lipocalin (NGAL)-to-creatinine, and UACR', 'urinary TGF- β 1, KIM-1, fibronectin, NGAL, or UACR', 'mean total CO 2', 'change in urinary TGF- β 1-to-creatinine']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016055', 'cui_str': 'Opsonic alpha(2)SB Glycoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0151650', 'cui_str': 'Renal fibrosis (disorder)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.452047,Sodium bicarbonate did not significantly change urinary,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Tristin', 'Initials': 'T', 'LastName': 'Bullshoe', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Kunani', 'Initials': 'K', 'LastName': 'Tuttle', 'Affiliation': 'Department of Internal Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Medicine Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06600619'] 763,30665606,"Exploring the association between changes in partner behaviors, perceived service member drinking, and relationship quality: Secondary analysis of a web-based intervention for military partners.","Problematic drinking is a serious and persistent problem among U.S. military service members and veterans, who face barriers to seeking help and are less likely to seek help than the civilian population. One way to reach this population is through spouses or partners who are concerned about the service members' drinking (concerned partners [CPs]). CPs of military service members were recruited for a web-based intervention, Partners Connect, that aimed to improve patterns of communication about the service members' drinking. Participants were 234 CPs (95% female; 71% White; 89% married; average age 32 years) who completed a baseline survey, were randomized to a four-session web-based intervention or a waitlist control group, and completed a follow-up assessment 5 months later. Three measures reported by CPs assessed perceived partner drinking (drinks per week, highest number of drinks across a typical week, and frequency of drinking in the past month) and CP behaviors were assessed using the Significant-other Behavior Questionnaire (SBQ) and the State-Trait Anger Expression Inventory (STAXI-2). Results demonstrated that the intervention did not have a main effect on CP behaviors relative to control. However, changes in CP punishment of partner drinking and behaviors supporting sobriety were significantly associated with decreased perceived partner drinking and improved relationship quality over time. Furthermore, compared to the control group, to the extent that CPs in the treatment group reduced their negative behaviors, perceived partner drinking declined and relationship quality improved. The results reinforce the importance of considering CP behaviors when designing interventions to reduce drinking.",2019,"However, changes in CP punishment of partner drinking and behaviors supporting sobriety were significantly associated with decreased perceived partner drinking and improved relationship quality over time.","['military partners', 'Participants were 234 CPs (95% female; 71% White; 89% married; average age 32\u202fyears) who completed a baseline survey', 'CPs of military service members']",[],"['Behavior Questionnaire (SBQ) and the State-Trait Anger Expression Inventory (STAXI-2', 'CPs assessed perceived partner drinking (drinks per week, highest number of drinks across a typical week, and frequency of drinking in the past month) and CP behaviors', 'CP punishment of partner drinking and behaviors supporting sobriety', 'CP behaviors', 'negative behaviors, perceived partner drinking declined and relationship quality', 'perceived partner drinking and improved relationship quality']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory (assessment scale)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034119', 'cui_str': 'Punishment'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",234.0,0.0157691,"However, changes in CP punishment of partner drinking and behaviors supporting sobriety were significantly associated with decreased perceived partner drinking and improved relationship quality over time.","[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Trail', 'Affiliation': 'RAND Corporation, United States of America. Electronic address: Thomas_Trail@rand.org.'}, {'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'RAND Corporation, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'University of South Florida -, St. Petersburg, United States of America.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Pedersen', 'Affiliation': 'RAND Corporation, United States of America.'}, {'ForeName': 'Kristie L', 'Initials': 'KL', 'LastName': 'Gore', 'Affiliation': 'RAND Corporation, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.002'] 764,30665599,A randomized trial of Volunteer Recovery Support for Adolescents (VRSA) following residential treatment discharge.,,2019,,['Adolescents (VRSA) following residential treatment discharge'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",[],[],,0.139977,,"[{'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Godley', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: mgodley@chestnut.org.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Passetti', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: lpassetti@chestnut.org.'}, {'ForeName': 'Brooke D', 'Initials': 'BD', 'LastName': 'Hunter', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: bdhunter@chestnut.org.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Greene', 'Affiliation': 'Indiana University, 1025 E. 7th St., Bloomington, IN 47405, United States of America; The University of Arizona, Southwest Institute for Research on Women, 181 S. Tucson Blvd., Ste. 101, Tucson, AZ 85716, United States of America. Electronic address: greene@email.arizona.edu.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'White', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Drive, Normal, IL 61761, United States of America. Electronic address: bwhite@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.11.014'] 765,30409040,Short sleep and late bedtimes are detrimental to educational learning and knowledge transfer: An investigation of individual differences in susceptibility.,"Good sleep hygiene practices, including consistent bedtimes and 7-9 h of sleep/night, are theorized to benefit educational learning. However, individuals differ in how much sleep they need, as well as in their chronotype preference. Therefore, some students may be more vulnerable to the cognitive effects of sleep loss, later bedtimes and nonpreferred times of learning than others. One prominent example is the debate regarding whether sleep loss and later bedtimes affect classroom learning more in female or male students. To inform this gender-and-sleep-loss debate, we developed a virtual college-level lecture to use in a controlled, laboratory setting. During Session 1, 78 undergraduate students were randomly assigned to take the lecture at 12:00 (noon condition) or 19:30 (evening condition). Then participants wore wristband actigraphy for 1 week to monitor average and intraindividual variability in sleep duration, bedtime and midpoint of sleep. During Session 2, participants completed a test at the same time of day as Session 1. The test included basic questions that were similar to trained concepts during the lecture (trained items) as well as integration questions that required application of learned concepts (knowledge-transfer items). Bayesian analyses supported the null hypothesis that time of learning did not affect test performance. Collapsed across time of testing, regression analyses showed that shorter sleep durations and later bedtimes explained 13% of the variance in test performance. Longer sleep durations and earlier bedtimes predicted better test performance primarily in females, younger students and morning-types. Interestingly, students with above-median fluid intelligence scores were resilient to short sleep and late bedtimes. Our findings indicate that both sleep and circadian factors should be addressed to optimize educational learning, particularly in the students who are most susceptible to sleep loss.",2019,"Collapsed across time of testing, regression analyses showed that shorter sleep durations and later bedtimes explained 13% of the variance in test performance.","['78 undergraduate students', 'female or male students']",[],"['Longer sleep durations', 'Good sleep hygiene practices', 'educational learning and knowledge transfer']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.0218134,"Collapsed across time of testing, regression analyses showed that shorter sleep durations and later bedtimes explained 13% of the variance in test performance.","[{'ForeName': 'Chenlu', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'a Department of Psychology and Neuroscience , Baylor University , Waco , USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Terlizzese', 'Affiliation': 'a Department of Psychology and Neuroscience , Baylor University , Waco , USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'a Department of Psychology and Neuroscience , Baylor University , Waco , USA.'}]",Chronobiology international,['10.1080/07420528.2018.1539401'] 766,30994898,Effect of a Quality of Care Improvement Initiative in Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China: A Randomized Clinical Trial.,"Importance Prior observational studies suggest that quality of care improvement (QCI) initiatives can improve the clinical outcomes of acute coronary syndrome (ACS). To our knowledge, this has never been demonstrated in a well-powered randomized clinical trial. Objective To determine whether a clinical pathway-based, multifaceted QCI intervention could improve clinical outcomes among patients with ACS in resource-constrained hospitals in China. Design, Setting, Participants This large, stepped-wedge cluster randomized clinical trial was conducted in nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014. We excluded patients who died before or within 10 minutes of hospital arrival. We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5. Interventions The intervention included establishing a QCI team, training clinical staff, implementing ACS clinical pathways, sequential site performance assessment and feedback, online technical support, and patient education. The usual care was the control that was compared. Main Outcomes and Measures The primary outcome was the incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke. Secondary outcomes included 16 key performance indicators (KPIs) and the composite score developed from these KPIs. Results Of 29 346 patients (17 639 men [61%]; mean [SD] age for control, 64.1 [11.6] years; mean [SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14 809 (50.5%) were in the control period and 14 537 (49.5%) were in the intervention period. There was no significant difference in the incidence of in-hospital MACE between the intervention and control periods after adjusting for cluster and time effects (3.9% vs 4.4%; odds ratio, 0.93; 95% CI, 0.75-1.15; P = .52). The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge. No unexpected adverse events were reported. Conclusions and Relevance Among resource-constrained Chinese hospitals, introducing a multifaceted QCI intervention had no significant effect on in-hospital MACE, although it improved a few of the care process indicators of evidence-based ACS management. Trial Registration ClinicalTrials.gov identifier: NCT01398228.",2019,"The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge.","['mean [SD] age for control, 64.1 [11.6] years; mean', 'nonpercutaneous coronary intervention hospitals across China and included all patients older than 18 years and with a final diagnosis of ACS who were recruited consecutively between October 2011 and December 2014', 'patients who died before or within 10 minutes of hospital arrival', 'We recruited 5768 and 0 eligible patients for the control and intervention groups, respectively, in step 1, 4326 and 1365 in step 2, 3278 and 3059 in step 3, 1419 and 4468 in step 4, and 0 and 5645 in step 5', 'patients with ACS in resource-constrained hospitals in China', 'Patients With Acute Coronary Syndrome in Resource-Constrained Hospitals in China', 'SD] age for intervention, 63.9 [11.7] years) who were recruited from 101 hospitals, 14\u202f809 (50.5%) were in the control period and 14\u202f537 (49.5%) were in the intervention period', 'Results\n\n\nOf 29\u202f346 patients (17\u202f639 men [61', 'acute coronary syndrome (ACS', 'Participants']","['multifaceted QCI intervention', 'Quality of Care Improvement Initiative']","['incidence of in-hospital MACE', 'incidence of in-hospital major adverse cardiovascular events (MACE), comprising all-cause mortality, reinfarction/myocardial infarction, and nonfatal stroke', 'adverse events', 'composite KPI score', '16 key performance indicators (KPIs) and the composite score developed from these KPIs']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",29346.0,0.142285,"The intervention showed a significant improvement in the composite KPI score (mean [SD], 0.69 [0.22] vs 0.61 [0.23]; P < .01) and in 7 individual KPIs, including the early use of antiplatelet therapy and the use of appropriate secondary prevention medicines at discharge.","[{'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Shenshen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'George Institute for Global Health, University of Oxford, Oxford, England.'}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Chinese Prevention Medical Association, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Dayi', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kalipso', 'Initials': 'K', 'LastName': 'Chalkidou', 'Affiliation': 'Global Health and Development, Imperial College, London, United Kingdom.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.0897'] 767,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female; M age  = 21.74, SD  = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, p < .0001), lower perceived control ( F (1, 276) = 205.523, p < .0001), and greater cortisol release ( F (1, 274) = 4.575, p = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female; M age \xa0=\xa021.74, SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885, ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685'] 768,30730774,The Parent-Child Relationship and Posttreatment Child Outcomes Across Two Treatments for Oppositional Defiant Disorder.,"This study examined the degree to which the parent-child relationship uniquely predicted clinical outcomes in externalizing problems and adaptive skills in children meeting diagnostic criteria for oppositional defiant disorder and whether facets of this relationship moderated the effects of two unique psychosocial treatments. We recruited 134 children and their parents (38.06% female; M age = 9.52 years, range = 7-14; 83.58% White). Families were randomly assigned to 1 of 2 treatments: Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS). We formed principal components from pretreatment reports and behaviors of the parent-child relationship to predict within- and between-family outcomes in children's externalizing problems and adaptive skills. Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness). Parental monitoring predicted fewer externalizing problems, whereas family permissiveness predicted more externalizing problems. Parental warmth predicted greatest improvements in children's adaptive skills among families receiving PMT. Family hostility predicted more externalizing problems and poorer adaptive skills for children; however, families receiving CPS were buffered from the negative effect of family hostility on adaptive skills. The parent-child relationship can uniquely inform posttreatment outcomes following treatment for oppositional defiant disorder. Certain treatment approaches may better fit unique relationships that emphasize warmth and/or hostility, allowing clinicians to anticipate and tailor treatments to families.",2020,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[""children's externalizing problems and adaptive skills"", 'children meeting diagnostic criteria for oppositional defiant disorder', '134 children and their parents (38.06% female; M age\xa0']",['Parent Management Training (PMT) and Collaborative and Proactive Solutions (CPS'],"['externalizing problems and poorer adaptive skills', ""children's adaptive skills"", 'externalizing problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4517748', 'cui_str': 'Thirty-eight point zero six'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",134.0,0.0478645,"Four principal components were supported (parental warmth, parental monitoring, family hostility, and family permissiveness).","[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Booker', 'Affiliation': 'Department of Psychological Sciences, University of Missouri.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Department of Psychology, University of Alabama.'}, {'ForeName': 'Ross W', 'Initials': 'RW', 'LastName': 'Greene', 'Affiliation': 'Child Study Center, Virginia Tech.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Tech.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1555761'] 769,30627737,Efficacy of midazolam addition to local anesthetic in peribulbar block : Randomized controlled trial.,"BACKGROUND Peribulbar block is considered a safe option for patients undergoing cataract surgery. The limited duration of regional eye blocks was shown to be the main problem. The objective of this study was to evaluate the effects of adjuvant midazolam (in two concentrations) to lidocaine in the peribulbar block. MATERIAL AND METHODS This study included 90 adult patients aged 40-70 years undergoing cataract surgery. Each patient was appointed to one of three groups. Group C received a single injection of a peribulbar block using a combination of lidocaine 2% and hyaluronidase 15 IU/ml, group M1 received a combination of lidocaine 2%, hyaluronidase 15 IU/ml plus midazolam 50 µg/ml and group M2 received lidocaine 2%, hyaluronidase 15 IU/ml plus midazolam 100 µg/ml. RESULTS The quality of the peribulbar block showed significant improvement among groups by one-way ANOVA (p = 0.002). The mean onset time of the sensory block was significantly shorter in the M2 and M1 groups (1.66 min and 2.17 min, respectively) compared to the control group C (2.52 min), while the onset of lid and globe akinesia lacked significance between the three groups (p = 0.23 and 0.06, respectively). Significance in mean values was found between the control (C) and M2 groups regarding orbicularis oculi function, digital spear pressure, topical anesthetic sting and the total score (P-values = 0.004, 0.016, 0.033 and 0.001, respectively). The duration of lid akinesia and sensory anesthesia were significantly different between the three groups (P = 0.048 and P<0.001, respectively) whereas the duration of globe akinesia was insignificant (P = 0.432). CONCLUSION Addition of midazolam to local anesthetic significantly improved the quality of peribulbar block, hastened the onset of sensory anesthesia, lid and globe akinesia and increased the duration of analgesia without notable side effects.",2019,"Significance in mean values was found between the control (C) and M2 groups regarding orbicularis oculi function, digital spear pressure, topical anesthetic sting and the total score (P-values = 0.004, 0.016, 0.033 and 0.001, respectively).","['90 adult patients aged 40-70\xa0years undergoing cataract surgery', 'patients undergoing cataract surgery', 'peribulbar block ']","['midazolam', 'lidocaine 2% and hyaluronidase 15\u202fIU/ml, group M1 received a\xa0combination of lidocaine 2%, hyaluronidase 15', 'lidocaine', 'IU/ml plus midazolam', 'hyaluronidase', 'adjuvant midazolam']","['duration of lid akinesia and sensory anesthesia', 'mean onset time of the sensory block', 'onset of sensory anesthesia, lid and globe akinesia', 'duration of globe akinesia', 'onset of lid and globe akinesia lacked significance', 'orbicularis oculi function, digital spear pressure, topical anesthetic sting and the total score', 'quality of peribulbar block']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar block'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0085623', 'cui_str': 'Akinesia (finding)'}, {'cui': 'C0278134', 'cui_str': 'Absence of sensation (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0336708', 'cui_str': 'Spear, device (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0038340', 'cui_str': 'Stings'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar block'}]",90.0,0.156568,"Significance in mean values was found between the control (C) and M2 groups regarding orbicularis oculi function, digital spear pressure, topical anesthetic sting and the total score (P-values = 0.004, 0.016, 0.033 and 0.001, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Zagazig University, Zagazig, Egypt. mibrahim72@hotmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gomaa', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Der Anaesthesist,['10.1007/s00101-018-0525-3'] 770,32072685,"Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic randomized study in humans.","OBJECTIVES To analyze a modified biphasic phycogenic biomaterial in comparison with anorganic bovine bone in maxillary sinus floor elevation in humans. MATERIAL AND METHODS Eight male patients in need of bilateral two-stage sinus floor elevation were consecutively recruited for this randomized split-mouth study. A combination of autogenous cortical bone (ACB, 20%) and anorganic bovine bone (ABB, 80%) (ACB + ABB group) or ACB (20%) and modified biphasic phycogenic material (BP, 80%) (ACB + BP group) were randomly assigned to graft each sinus. Patients were followed up for 6 months post-surgery when bone samples were collected for analysis. RESULTS Radiographically, bone height gain was statistically higher in the ACB + ABB versus the ACB + BP group. While the analysis of the biological compartments showed differences in non-mineralized tissue (39.15 ± 20.97% vs. 65.87 ± 28.59%, ACB + ABB vs. ACB + BP respectively; p = .018) and remnant biomaterial particles (22.62 ± 17.01% vs. 7.96 ± 8.57%, respectively; p = .028), the percentage of mineralized tissue (38.23 ± 17.55% vs. 24.14 ± 24.66%, respectively; p = .398) showed no statistically significant difference. In contrast, ACB + ABB biopsies showed higher Musashi-1-positive cells per mm 2 compared to ACB + BP biopsies (811.49 ± 875.30 vs. 236.90 ± 280.81; p < .018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis. CONCLUSION Both combinations of materials exhibited bone formation after 6 months of healing in the maxillary sinus cavity. However, the combination with biphasic phycogenic biomaterial induced a higher radiographical vertical resorption and graft collapse in comparison with the combination with anorganic bovine bone, possibly due to a higher remodeling of the graft.",2020,"In contrast, ACB+ABB biopsies showed higher Musashi-1 positive cells per mm 2 compared to ACB+BP biopsies (811.49±875.30 vs. 236.90±280.81; p<0.018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis. ","['Eight male patients in need of bilateral two-stage sinus floor elevation', 'comparison with anorganic bovine bone in maxillary sinus floor elevation in humans', 'humans']","['autogenous cortical bone (ACB, 20%) and anorganic bovine bone (ABB, 80%) (ACB+ABB group) or ACB (20%) and modified biphasic phycogenic material (BP, 80%) (ACB+BP']","['radiographical vertical resorption and graft collapse', 'bone height gain', 'percentage of mineralized tissue', 'non-mineralized tissue', 'remnant biomaterial particles', 'Musashi-1 positive cells']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",8.0,0.0959988,"In contrast, ACB+ABB biopsies showed higher Musashi-1 positive cells per mm 2 compared to ACB+BP biopsies (811.49±875.30 vs. 236.90±280.81; p<0.018), where the fusiform cells corresponded mainly with fibroblasts, as demonstrated by ultrastructural analysis. ","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo-Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Padial-Molina', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Lopez-Chaichio', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Gutiérrez-Garrido', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Martín-Morales', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': ""O'Valle"", 'Affiliation': 'Department of Pathology and IBIMER, School of Medicine, University of Granada, Granada, Spain.'}]",Clinical oral implants research,['10.1111/clr.13590'] 771,30096657,Development and validation of a contextual behavioral distress intolerance task in cigarette smokers.,"INTRODUCTION Distress intolerance, an individual's perceived or actual inability to withstand negative emotional or physical distress, contributes to the maintenance of smoking. However, there is limited understanding of the contextual factors that impact distress intolerance in general or among smokers specifically. This study aimed to adapt and test a computerized behavioral persistence task that requires re-typing a passage while adhering to specific instructions (Contextual-Frustration Intolerance Typing Task [C-FiTT]). C-FiTT was designed to model contextual factors that influence distress intolerance, negative affect, and smoking urges. METHOD Daily smokers (n = 550) were recruited through the use of Qualtrics Panels. Using a 2 × 2 + 1 experimental design, participants were randomly assigned to one of four C-FiTT conditions that crossed task difficulty (low or high difficulty) with passage content (neutral or tobacco withdrawal text), or a neutral control group. RESULTS C-FiTT produced an average persistence time of 94.1 ± 114.3 s and 64.7% of participants self-terminated the task. C-FiTT also produced small to medium sized-increases in negative affect and smoking urges. Between-condition comparisons indicated that the high-difficulty C-FiTT produced shorter behavioral persistence, greater self-termination likelihood, and larger increases in negative affect and smoking urges. The combination of high-difficulty and withdrawal content resulted in the shortest persistence time, 100% self-termination rate, and largest increases in negative affect and smoking urges, compared to other conditions CONCLUSIONS: Findings provide initial evidence for the validity of C-FiTT in smokers within the context of tobacco withdrawal at low and high levels of task difficulty. Avenues for refinement and use of C-FiTT are discussed.",2018,"Between-condition comparisons indicated that the high-difficulty C-FiTT produced shorter behavioral persistence, greater self-termination likelihood, and larger increases in negative affect and smoking urges.","['Daily smokers (n\u202f=\u202f550', 'cigarette smokers']","['C-FiTT conditions that crossed task difficulty (low or high difficulty) with passage content (neutral or tobacco withdrawal text), or a neutral control group']","['behavioral persistence, greater self-termination likelihood']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0060398', 'cui_str': 'FITT'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",550.0,0.0156168,"Between-condition comparisons indicated that the high-difficulty C-FiTT produced shorter behavioral persistence, greater self-termination likelihood, and larger increases in negative affect and smoking urges.","[{'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, United States; The Miriam Hospital, Providence, RI, United States; Rutgers, the State University of New Jersey, Piscataway, NJ, United States. Electronic address: samantha_farris@brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'University of Houston, Houston, TX, United States; University of Texas MD Anderson Cancer Center, Houston, TX, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.07.020'] 772,30649970,Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial.,"Children adopted internationally are often dysregulated biologically and behaviorally due to prior experiences of institutional care or caregiving changes and thus are in need of enhanced parental care. The present study assessed whether parents randomized to receive Attachment and Biobehavioral Catch-up (ABC) demonstrated significant improvements in parenting quality when compared to parents receiving a control intervention. Participants were 120 internationally adopted children and their adoptive parents. Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female. Children were adopted from several countries and predominantly from China, Russia, South Korea, and Ethiopia. The majority of parents identified themselves as White/non-Hispanic (95.0%). At the start of intervention, parents ranged in age from 26.2 to 51.1 years old ( M = 39.7, SD  = 6.0), and children ranged in age from 6.8 months to 48.4 months ( M = 21.9, SD  = 9.0). Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy), and positive regard (i.e., positive affect expressed towards a child) were assessed at preintervention, immediately postintervention, and at annual follow-up visits. Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up. Findings add to the growing evidence that ABC improves parenting abilities, extending findings to adoptive parents and demonstrating that improvements in parenting quality were sustained several years after completion of the intervention. Trial registration: ClinicalTrials.gov NCT00816621.",2020,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","['parents ranged in age from 26.2 to 51.1\xa0years old (M=\xa039.7, SD\xa0=\xa06.0), and children ranged in age from 6.8\xa0months to 48.4\xa0months (M =\xa021.9, SD\xa0=\xa09.0', 'Participants were 120 internationally adopted children and their adoptive parents', 'Young Children', 'Sixty-three (52.5%) of the children and 113 (94.2%) of the primary caregivers were female']","['ABC', 'Attachment and Biobehavioral Catch-up (ABC', 'control intervention']","['Enhancing Parenting Quality', 'parenting abilities', 'parenting quality', ""Sensitivity (i.e., contingent responsiveness to a child's cues), intrusiveness (i.e., physical and/or verbal behavior that interferes with a child's autonomy""]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0337541', 'cui_str': 'Adopted child (person)'}, {'cui': 'C0337466', 'cui_str': 'Adoptive parent (person)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042530', 'cui_str': 'Verbal Behavior'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}]",120.0,0.0406424,"Parents who received ABC showed better parenting quality at postintervention than parents who received a control intervention, and these effects persisted at a 2-year follow-up.","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Department of Psychology, Stony Brook University.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychiatry, University of Connecticut Health Center.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wallin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1547972'] 773,30650624,"Effect of a Multidimensional Physical Activity Intervention on Body Mass Index, Skinfolds and Fitness in South African Children: Results from a Cluster-Randomised Controlled Trial.","Obesity-related conditions impose a considerable and growing burden on low- and middle-income countries, including South Africa. We aimed to assess the effect of twice a 10-week multidimensional, school-based physical activity intervention on children's health in Port Elizabeth, South Africa. A cluster-randomised controlled trial was implemented from February 2015 to May 2016 in grade 4 classes in eight disadvantaged primary schools. Interventions consisted of physical education lessons, moving-to-music classes, in-class activity breaks and school infrastructure enhancement to promote physical activity. Primary outcomes included cardiorespiratory fitness, body mass index (BMI) and skinfold thickness. Explanatory variables were socioeconomic status, self-reported physical activity, stunting, anaemia and parasite infections. Complete data were available from 746 children. A significantly lower increase in the mean BMI Z-score (estimate of difference in mean change: -0.17; 95% confidence interval (CI): -0.24 to -0.09; p < 0.001) and reduced increase in the mean skinfold thickness (difference in mean change: -1.06; 95% CI: -1.83 to -0.29; p = 0.007) was observed in intervention schools. No significant group difference occurred in the mean change of cardiorespiratory fitness ( p > 0.05). These findings show that a multidimensional, school-based physical activity intervention can reduce the increase in specific cardiovascular risk factors. However, a longer and more intensive intervention might be necessary to improve cardiorespiratory fitness.",2019,No significant group difference occurred in the mean change of cardiorespiratory fitness ( p > 0.05).,"['South African Children', 'February 2015 to May 2016 in grade 4 classes in eight disadvantaged primary schools', ""children's health in Port Elizabeth, South Africa"", '746 children']","['Multidimensional Physical Activity Intervention', 'physical education lessons, moving-to-music classes, in-class activity breaks and school infrastructure enhancement', '10-week multidimensional, school-based physical activity intervention']","['specific cardiovascular risk factors', 'cardiorespiratory fitness', 'mean skinfold thickness', 'Body Mass Index, Skinfolds and Fitness', 'cardiorespiratory fitness, body mass index (BMI) and skinfold thickness', 'mean BMI Z-score', 'socioeconomic status, self-reported physical activity, stunting, anaemia and parasite infections', 'mean change of cardiorespiratory fitness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C1299988', 'cui_str': 'MOVED TO (attribute)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0030499', 'cui_str': 'Parasitic Infections'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0522638,No significant group difference occurred in the mean change of cardiorespiratory fitness ( p > 0.05).,"[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Müller', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. ivan.mueller@unibas.ch.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. christian.schindler@swisstph.ch.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. larissa.adams13@gmail.com.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Endes', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, CH-4052 Basel, Switzerland. katharina.endes@unibas.ch.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Gall', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, CH-4052 Basel, Switzerland. stefanie.gall@unibas.ch.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, CH-4052 Basel, Switzerland. markus.gerber@unibas.ch.'}, {'ForeName': 'Nan S N', 'Initials': 'NSN', 'LastName': 'Htun', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. shwenwetun@gmail.com.'}, {'ForeName': 'Siphesihle', 'Initials': 'S', 'LastName': 'Nqweniso', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. felicitas.nqweniso@mandela.ac.za.'}, {'ForeName': 'Nandi', 'Initials': 'N', 'LastName': 'Joubert', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. nandi.joubert@mandela.ac.za.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Probst-Hensch', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. nicole.probst@swisstph.ch.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'du Randt', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. rosa.durandt@mandela.ac.za.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Seelig', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, CH-4052 Basel, Switzerland. harald.seelig@unibas.ch.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. danielle.smith@mandela.ac.za.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Steinmann', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. peter.steinmann@swisstph.ch.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. juerg.utzinger@swisstph.ch.'}, {'ForeName': 'Peiling', 'Initials': 'P', 'LastName': 'Yap', 'Affiliation': 'Swiss Tropical and Public Health Institute, P.O. Box, CH-4002 Basel, Switzerland. peiling.yap@gmail.com.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Department of Human Movement Science, South Campus, P.O. Box 77000, Nelson Mandela University, Port Elizabeth 6031, South Africa. cheryl.walter@mandela.ac.za.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, CH-4052 Basel, Switzerland. uwe.puehse@unibas.ch.'}]",International journal of environmental research and public health,['10.3390/ijerph16020232'] 774,31206066,Improving patients' ability to identify their physicians through the use of physician facecards and whiteboards.,"Background Hospitalised patients are often not able to correctly identify members of their physician team. Identifying physicians is a critical component of developing the patient-physician relationship and visual aids have been shown to improve physician identification and overall patient satisfaction. Objectives The aim of this quality improvement study was to assess the impact of implementation of a physician facecard on the ability of patients to identify their attending physician and other members of the physician team, as well as to evaluate current use of patient whiteboards for physician team identification. Methods We prospectively studied 149 patients admitted to the medicine teaching service, who were randomised to receive a physician facecard or usual care. Patients were surveyed to determine their ability to identify physician team members. Observational data was also collected regarding use of patient whiteboards. Additionally, all hospitalists were surveyed to assess their perception of these visual aids. Results Patients who received the facecard were more likely to recall the name of the attending physician as compared with the control group (63% vs 32%, p<0.01). Additionally, 68% of patients with the attending name correctly listed on their whiteboard were able to correctly identify the attending physician (p<0.01). Ninety per cent of patients who both received a facecard and had their whiteboard correctly filled out were able to identify the attending physician. Eighty per cent of hospitalists surveyed agreed that use of the facecard added value and 90% disagreed that routine use of the facecard was burdensome. Conclusion The use of physician facecards improves the ability of hospitalised patients to identify their attending physicians, and the combined use of facecards and whiteboards may provide additive benefits.",2019,"The use of physician facecards improves the ability of hospitalised patients to identify their attending physicians, and the combined use of facecards and whiteboards may provide additive benefits.","['patients to identify their attending physician and other members of the physician team', '149 patients admitted to the medicine teaching service']",['physician facecard or usual care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}]",[],149.0,0.0223769,"The use of physician facecards improves the ability of hospitalised patients to identify their attending physicians, and the combined use of facecards and whiteboards may provide additive benefits.","[{'ForeName': 'Kramer', 'Initials': 'K', 'LastName': 'Wahlberg', 'Affiliation': 'Internal Medicine, University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Lambirth', 'Affiliation': 'Internal Medicine, University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Zechariah', 'Initials': 'Z', 'LastName': 'Gardner', 'Affiliation': 'Internal Medicine, University of Vermont Medical Center, Burlington, Vermont, USA.'}]",BMJ open quality,['10.1136/bmjoq-2018-000606'] 775,30256905,"The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial.","BACKGROUND Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and systemic reactions. This study assessed the impact of RZV on the quality of life and daily functioning of participants and implications for caregivers. METHODS Four hundred and one adults aged 50 years or older received single RZV doses at 0 and 2 months in this open-label, single-arm, multicenter study (NCT02979639). Change in mean SF-36 Physical Functioning score following first-dose administration, quality of life, reactogenicity, safety, productivity loss, and health care resource utilization was assessed. The current analysis was performed post-vaccine dose-1; safety follow-up will continue until 1 year post-dose-2. RESULTS The most common solicited local symptoms were injection-site pain (77.5%), redness (23.0%), and swelling (13.3%); the most frequent solicited systemic reactions were fatigue (33.5%), headache (28.3%), and myalgia (26.8%). Grade 3 reactogenicity occurred in 9.5% of participants and was associated with a transient clinically important decrease in SF-36 Physical Functioning score (affecting activities such as walking, carrying groceries, climbing stairs) on Days 1 and 2 post-first vaccination. No clinically meaningful reductions in mean SF-36 Physical Functioning scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary end point), and no overall quality-adjusted-life-year loss was recorded post-dose-1. Five participants reported lost workdays; caregiver workload was not increased. CONCLUSIONS Overall, the physical functioning and quality of life of older adults were not affected by a first RZV dose. The observed reactogenicity was consistent with previous studies.",2019,"No clinically meaningful reductions in mean SF-36 PF scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary endpoint) and no overall quality-adjusted-life-year loss was recorded post-dose-1.","['participants and implications for caregivers', '401 adults aged ≥50 years received', 'older adults']","['RZV', 'single RZV', 'recombinant zoster vaccine', 'recombinant zoster vaccine (RZV']","['swelling', 'lost workdays; caregiver workload', 'Grade 3 reactogenicity', 'SF-36 PF score (impacting activities such as walking, carrying groceries, climbing stairs', 'mean SF-36 PF scale scores', 'headache', 'mean SF-36 Physical Functioning (PF) score', 'physical functioning and quality of life', 'redness', 'overall quality-adjusted-life-year loss', 'QoL, reactogenicity, safety, productivity loss and healthcare resource utilization', 'myalgia']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",401.0,0.225848,"No clinically meaningful reductions in mean SF-36 PF scale scores from pre- to post-RZV dose-1 were observed (mean +1.9 points, primary endpoint) and no overall quality-adjusted-life-year loss was recorded post-dose-1.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, North Carolina.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Grupping', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butuk', 'Affiliation': 'Solaris Clinical Research, Meridian, Idaho.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The Corvallis Clinic, Oregon.'}, {'ForeName': 'Mohamed El', 'Initials': 'ME', 'LastName': 'Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Fissette', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, South Carolina.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hartley', 'Affiliation': 'Preferred Primary Care Physicians, Uniontown, Pennsylvania.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Klein', 'Affiliation': 'Kaiser Permanente Vaccine Study Center, Oakland, California.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nevarez', 'Affiliation': 'DaVita Medical Group, Colorado Springs, Colorado.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Uusinarkaus', 'Affiliation': 'DaVita Medical Group, Colorado Springs, Colorado.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly218'] 776,30473366,Effects of the Learning Together intervention on bullying and aggression in English secondary schools (INCLUSIVE): a cluster randomised controlled trial.,"BACKGROUND Bullying, aggression, and violence among children and young people are some of the most consequential public mental health problems. We tested the Learning Together intervention, which involved students in efforts to modify their school environment using restorative practice and by developing social and emotional skills. METHODS We did a cluster randomised trial, with economic and process evaluations, of the Learning Together intervention compared with standard practice (controls) over 3 years in secondary schools in south-east England. Learning Together consisted of staff training in restorative practice; convening and facilitating a school action group; and a student social and emotional skills curriculum. Primary outcomes were self-reported experience of bullying victimisation (Gatehouse Bullying Scale; GBS) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime (ESYTC) school misbehaviour subscale) measured at 36 months. We analysed data using intention-to-treat longitudinal mixed-effects models. This trial was registered with the ISRCTN registry (10751359). FINDINGS We included 40 schools (20 in each group); no schools withdrew. 6667 (93·6%) of 7121 students participated at baseline and 5960 (83·3%) of 7154 at 36 months. Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08). Mean ESYTC score at 36 months was 4·33 (SE 0·20) in the control group versus 4·04 (0·21) in the intervention group, with no evidence of a difference between groups (adjusted difference -0·13, 95% CI -0·43 to 0·18; adjusted effect size -0·03). Costs were an additional £58 per pupil in intervention schools than in control schools. INTERPRETATION Learning Together had small but significant effects on bullying, which could be important for public health, but no effect on aggression. Interventions to promote student health by modifying the whole-school environment are likely to be one of the most feasible and efficient ways of addressing closely related risk and health outcomes in children and young people. FUNDING National Institute for Health Research, Educational Endowment Foundation.",2018,"Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08).","['English secondary schools (INCLUSIVE', 'over 3 years in secondary schools in south-east England', '6667', '7121 students participated at baseline and 5960 (83·3%) of 7154 at 36 months', 'children and young people', '40 schools (20 in each group); no schools withdrew']","['Learning Together intervention compared with standard practice (controls', 'Learning Together intervention', 'student social and emotional skills curriculum']","['Mean GBS bullying score', 'Mean ESYTC score', 'bullying and aggression', 'self-reported experience of bullying victimisation (Gatehouse Bullying Scale; GBS) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime (ESYTC) school misbehaviour subscale']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C4708906', 'cui_str': 'Six thousand six hundred and sixty-seven'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0036375', 'cui_str': 'School'}]",7121.0,0.194397,"Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08).","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK. Electronic address: chris.bonell@lshtm.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McGowan', 'Affiliation': 'University College London Great Ormond St Institute of Child Health, London, UK.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': 'University College London Great Ormond St Institute of Child Health, London, UK.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Jamal', 'Affiliation': 'University College London Institute of Education, London, UK.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Legood', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Wiggins', 'Affiliation': 'University College London Institute of Education, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathiot', 'Affiliation': 'University College London Great Ormond St Institute of Child Health, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Fletcher', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK; Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Christie', 'Affiliation': 'University College London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Victoria University, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Institute of Psychiatry Psychology & Neurology, London, UK.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Viner', 'Affiliation': 'University College London Great Ormond St Institute of Child Health, London, UK. Electronic address: r.viner@ucl.ac.uk.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)31782-3'] 777,30580725,Scoring System to Optimize Pioglitazone Therapy After Stroke Based on Fracture Risk.,"Background and Purpose- The insulin sensitizer, pioglitazone, reduces cardiovascular risk in patients after an ischemic stroke or transient ischemic attack but increases bone fracture risk. We conducted a secondary analysis of the IRIS trial (Insulin Resistance Intervention After Stroke) to assess the effect of pretreatment risk for fracture on the net benefits of pioglitazone therapy. Methods- IRIS was a randomized placebo-controlled trial of pioglitazone that enrolled patients with insulin resistance but without diabetes mellitus within 180 days of an ischemic stroke or transient ischemic attack. Participants were recruited at 179 international centers from February 2005 to January 2013 and followed for a median of 4.8 years. Fracture risk models were developed from patient characteristics at entry. Within fracture risk strata, we quantified the effects of pioglitazone compared with placebo by estimating the relative risks and absolute 5-year risk differences for fracture and stroke or myocardial infarction. Results- The fracture risk model included points for age, race-ethnicity, sex, body mass index, disability, and medications. The relative increment in fracture risk with pioglitazone was similar in the lower (250 µg/g stool and for UC as a Mayo score >5 with endoscopic subscore >1 or as the occurrence of adverse events requiring to stop treatment. Unfavourable pharmacokinetics of the second anti-TNF were defined by the appearance of undetectable trough levels of anti-TNF with high antibodies (drug-sensitive assay) or by that of antibodies (drug-tolerant assay). RESULTS Ninety patients (48 CDs) were included, and 45 of them received AZA after randomisation. The second anti-TNF was adalimumab or infliximab in 40 and 50 patients, respectively. Rates of clinical failure and occurrence of unfavourable pharmacokinetics were higher in monotherapy compared with combination therapy (p<0.001; median time of clinical failure since randomisation 18 vs >24 months). At 24 months, survival rates without clinical failure and without appearance of unfavourable pharmacokinetics were respectively 22 versus 77% and 22% versus 78% (p<0.001 for both) in monotherapy versus combination therapy. Only the use of combination therapy was associated with favourable outcomes after anti-TNF switch. CONCLUSION In case of immune-mediated LOR to a first anti-TNF, AZA should be associated with the second anti-TNF. TRIAL REGISTRATION NUMBER 03580876.",2020,Rates of clinical failure and occurrence of unfavourable pharmacokinetics were higher in monotherapy compared with combination therapy (p<0.001; median time of clinical failure since randomisation 18 vs >24 months).,"['patients with IBD in clinical relapse with undetectable anti-TNF trough levels and antidrug antibodies', 'patients with IBD experiencing an', 'Consecutive IBD patients in immune-mediated LOR to a first optimised anti-TNF given in monotherapy', 'Ninety patients (48\u2009CDs']","['azathioprine', 'switch to a second anti-TNF alone or with addition of azathioprine (AZA', 'AZA', 'adalimumab or infliximab', 'AZA or nothing with induction by a second anti-TNF']","['survival rates without clinical failure and without appearance of unfavourable pharmacokinetics', 'immune-mediated loss of response (LOR', 'Rates of clinical failure and occurrence of unfavourable pharmacokinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.044973,Rates of clinical failure and occurrence of unfavourable pharmacokinetics were higher in monotherapy compared with combination therapy (p<0.001; median time of clinical failure since randomisation 18 vs >24 months).,"[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Department of Gastroenterology, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Williet', 'Affiliation': 'Department of Gastroenterology, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Boschetti', 'Affiliation': 'Department of Gastroenterology, Hospital Lyon-South, Pierre-Benite, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Department of Gastroenterology, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Del Tedesco', 'Affiliation': 'Department of Gastroenterology, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Anne-Emmanuelle', 'Initials': 'AE', 'LastName': 'Berger', 'Affiliation': 'Department of Immunology, CIC 1408, GIMAP, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vedrines', 'Affiliation': 'Gastro-enterology Department, Centre Hospitalier du Forez à Montbrison Instituts de Formation, Montbrison, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Duru', 'Affiliation': 'Department of Statistics, UCBL, Villeurbanne, Auvergne-Rhône-Alpes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of gastroenterology, University Hospital Centre Nancy, Nancy, Lorraine, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Nancey', 'Affiliation': 'Department of Gastroenterology, Hospital Lyon-South, Pierre-Benite, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Flourie', 'Affiliation': 'Department of Gastroenterology, Hospital Lyon-South, Pierre-Benite, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Immunology, CIC 1408, GIMAP, CHU Saint-Étienne, Saint-Etienne, Rhône-Alpes, France stephane.paul@chu-st-etienne.fr.'}]",Gut,['10.1136/gutjnl-2019-319758'] 785,29058358,An investigation of regional cerebral blood flow and tissue structure changes after acute administration of antipsychotics in healthy male volunteers.,"Chronic administration of antipsychotic drugs has been linked to structural brain changes observed in patients with schizophrenia. Recent MRI studies have shown rapid changes in regional brain volume following just a single dose of these drugs. However, it is not clear if these changes represent real volume changes or are artefacts (""apparent"" volume changes) due to drug-induced physiological changes, such as increased cerebral blood flow (CBF). To address this, we examined the effects of a single, clinical dose of three commonly prescribed antipsychotics on quantitative measures of T1 and regional blood flow of the healthy human brain. Males (n = 42) were randomly assigned to one of two parallel groups in a double-blind, placebo-controlled, randomized, three-period cross-over study design. One group received a single oral dose of either 0.5 or 2 mg of risperidone or placebo during each visit. The other received olanzapine (7.5 mg), haloperidol (3 mg), or placebo. MR measures of quantitative T1, CBF, and T1-weighted images were acquired at the estimated peak plasma concentration of the drug. All three drugs caused localized increases in striatal blood flow, although drug and region specific effects were also apparent. In contrast, all assessments of T1 and brain volume remained stable across sessions, even in those areas experiencing large changes in CBF. This illustrates that a single clinically relevant oral dose of an antipsychotic has no detectable acute effect on T1 in healthy volunteers. We further provide a methodology for applying quantitative imaging methods to assess the acute effects of other compounds on structural MRI metrics. Hum Brain Mapp 39:319-331, 2018. © 2017 Wiley Periodicals, Inc.",2018,"In contrast, all assessments of T1 and brain volume remained stable across sessions, even in those areas experiencing large changes in CBF.","['healthy human brain', 'Males (n\u2009=\u200942', 'healthy volunteers', 'healthy male volunteers', 'patients with schizophrenia']","['risperidone or placebo', 'placebo', 'antipsychotic', 'antipsychotic drugs', 'antipsychotics', 'haloperidol', 'olanzapine']","['regional brain volume', 'cerebral blood flow (CBF', 'striatal blood flow', 'T1 and brain volume', 'MR measures of quantitative T1, CBF, and T1-weighted images']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",,0.160149,"In contrast, all assessments of T1 and brain volume remained stable across sessions, even in those areas experiencing large changes in CBF.","[{'ForeName': 'Peter C T', 'Initials': 'PCT', 'LastName': 'Hawkins', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Tobias C', 'Initials': 'TC', 'LastName': 'Wood', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Vernon', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bertolino', 'Affiliation': 'Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari BA, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sambataro', 'Affiliation': 'Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'Translational Medicine Neuroscience and Biomarkers, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Merlo-Pich', 'Affiliation': 'CNS Therapeutic Area Unit, Takeda Development Centre Europe, London, United Kingdom.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Risterucci', 'Affiliation': 'Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Silber-Baumann', 'Affiliation': 'Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Ndabezinhle', 'Initials': 'N', 'LastName': 'Mazibuko', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}]",Human brain mapping,['10.1002/hbm.23844'] 786,31983494,Oral Ondansetron to Reduce Vomiting in Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia: A Randomized Controlled Trial.,"STUDY OBJECTIVE Intranasal fentanyl and inhaled nitrous oxide are increasingly combined to provide procedural sedation and analgesia in the pediatric emergency setting. This regimen is attractive because of its nonparenteral administration, but is associated with a higher incidence of vomiting than nitrous oxide alone. We seek to assess whether prophylactic oral ondansetron use could reduce the incidence of vomiting associated with intranasal fentanyl and nitrous oxide for procedural sedation compared with placebo. METHODS This was a double-blind, randomized controlled trial of oral ondansetron versus placebo conducted at a single tertiary care pediatric emergency department. Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide were randomized to receive oral ondansetron or placebo 30 to 60 minutes before nitrous oxide administration. The primary outcome was early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration. Secondary outcomes included vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups. RESULTS We recruited 442 participants and 436 were included for analysis. There was no significant difference in the primary outcome, early vomiting associated with procedural sedation, between the groups: ondansetron 12% versus placebo 16%, with a difference in proportions of -4.6% (95% confidence interval -11% to 2.0%; P=.18). Most sedations were reported as optimal by treating clinicians (91%). Only 2 minor adverse events occurred, both in the placebo group. CONCLUSION Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.",2020,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"['442 participants and 436 were included for analysis', 'Children aged 3 to 18 years with planned sedation with intranasal fentanyl and nitrous oxide', 'single tertiary care pediatric emergency department', 'Children Receiving Intranasal Fentanyl and Inhaled Nitrous Oxide for Procedural Sedation and Analgesia']","['fentanyl and inhaled nitrous oxide', 'oral ondansetron or placebo', 'ondansetron', 'Oral ondansetron', 'placebo', 'oral ondansetron', 'Oral Ondansetron', 'inhaled nitrous oxide']","['Vomiting', 'incidence of vomiting', 'vomiting 1 to 24 hours after procedural sedation, procedural sedation duration, adverse events, and quality of sedation across the 2 groups', 'early vomiting associated with procedural sedation', 'vomiting', 'adverse events', 'early vomiting associated with procedural sedation, defined as occurring during or up to 1 hour after nitrous oxide administration']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",442.0,0.574584,Oral ondansetron does not significantly reduce vomiting during or shortly after procedural sedation with combined intranasal fentanyl and inhaled nitrous oxide.,"[{'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fauteux-Lamarre', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'Quinn', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Legge', 'Affiliation': ""Department of Pharmacy, The Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia; Melbourne Children's Trials Centre, Melbourne, Victoria, Australia.""}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Palmer', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Emergency Department, The Royal Children's Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.019'] 787,31980334,"The effect of the video and brochure via donor recruitment on fear, anxiety and intention: Randomized controlled trial.","Although voluntary blood donation is important in terms of sustainable blood supply, voluntary blood donation rates in the world and in our country are behind the desired target. University students are an important group in achieving the goal. The study was planned among 551 university students between 19-21 March 2018.It was planned as a single-blind randomized controlled study in order to evaluate the factors affecting students' blood donation decision and the effect of brochure and video information on fear, anxiety and intention. The data obtained by using Blood Donation Questionnaire and State Anxiety Scale and p ≤ 0.05 was accepted as significant. As a result of the study, 37.9 % of the students reported that they did not give blood due to health reasons, 26 % insecurity and 24.1 % fear. The increase in after the intervention knowledge level was mostly in the group of videos and improved brochures (p < 0.001).There was no difference between the groups in terms of the State Anxiety Scale mean scores p> 0.05). In after the intervention, those who intend to give blood have higher knowledge and their fear and anxiety scores less than those not intend to give blood (p < 0.05). There was no difference between the groups in terms of intention to give blood after the intervention (p> 0.05). As a result, it was found that the information given through the developed brochures and videos increased the level of knowledge, had no effect on the anxiety level and it can be said that the improved brochure has positive effects on intent and fear.",2020,There was no difference between the groups in terms of intention to give blood after the intervention (p> 0.05).,"['551 university students between 19-21 March 2018.It', 'University students']",['video and brochure via donor recruitment'],"['fear, anxiety and intention', 'anxiety level', 'Blood Donation Questionnaire and State Anxiety Scale', 'knowledge and their fear and anxiety scores', 'intention to give blood']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C4316802', 'cui_str': 'Blood donation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0222045'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005768'}]",,0.020992,There was no difference between the groups in terms of intention to give blood after the intervention (p> 0.05).,"[{'ForeName': 'Yıldız', 'Initials': 'Y', 'LastName': 'Karacaoğlu', 'Affiliation': 'Turkish Red Crescent, Mersin Blood Donations Center, Mersin, Turkey. Electronic address: yildizkaracaoglu33@gmail.com.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Öncü', 'Affiliation': 'Turkish Red Crescent, Mersin Blood Donations Center, Mersin, Turkey. Electronic address: eeoncu@gmail.com.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2019.102698'] 788,29343089,Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.,"OBJECTIVE In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control. METHODS A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners. RESULTS Improvement in A1c was associated with having a peer older than oneself ( P < .05) or with higher diabetes-related distress ( P < .01). Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01). Hypothesized concordant characteristics were not associated with A1c improvements. Participants whose peers had a more controlled self-regulation style were more likely to initiate insulin ( P < .05). DISCUSSION The improved outcomes of peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.",2019,Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01).,['102 adults with diabetes'],['reciprocal peer support program'],"['diabetes distress', 'glycemic control', 'controlled self-regulation style', 'insulin initiation and peer engagement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",102.0,0.11209,Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01).,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kaselitz', 'Affiliation': '1 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': '3 Department of Family and Preventive Medicine, 12239 Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Hwajung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': '4 Department of Internal Medicine, 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': '1 12266 University of Michigan Medical School , Ann Arbor, MI, USA.'}]",Chronic illness,['10.1177/1742395317753884'] 789,31682586,Development of a Deep Learning Model for Dynamic Forecasting of Blood Glucose Level for Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND Type 2 diabetes mellitus (T2DM) is a major public health burden. Self-management of diabetes including maintaining a healthy lifestyle is essential for glycemic control and to prevent diabetes complications. Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM. OBJECTIVE The objective of this work was to dynamically forecast daily glucose levels in patients with T2DM based on their daily mobile health lifestyle data including diet, physical activity, weight, and glucose level from the day before. METHODS We used data from 10 T2DM patients who were overweight or obese in a behavioral lifestyle intervention using mobile tools for daily monitoring of diet, physical activity, weight, and blood glucose over 6 months. We developed a deep learning model based on long short-term memory-based recurrent neural networks to forecast the next-day glucose levels in individual patients. The neural network used several layers of computational nodes to model how mobile health data (food intake including consumed calories, fat, and carbohydrates; exercise; and weight) were progressing from one day to another from noisy data. RESULTS The model was validated based on a data set of 10 patients who had been monitored daily for over 6 months. The proposed deep learning model demonstrated considerable accuracy in predicting the next day glucose level based on Clark Error Grid and ±10% range of the actual values. CONCLUSIONS Using machine learning methodologies may leverage mobile health lifestyle data to develop effective individualized prediction plans for T2DM management. However, predicting future glucose levels is challenging as glucose level is determined by multiple factors. Future study with more rigorous study design is warranted to better predict future glucose levels for T2DM management.",2019,"Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM. ","['Type 2 Diabetes Mellitus', '10 patients who had been monitored daily for over 6 months', 'patients with T2DM based on their daily mobile health lifestyle data including diet, physical activity, weight, and glucose level from the day before', 'individual patients', '10 T2DM patients who were overweight or obese in a behavioral lifestyle intervention using mobile tools for daily monitoring of diet, physical activity, weight, and blood glucose over 6 months']",[],['Blood Glucose Level'],"[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",[],"[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",,0.0239665,"Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM. ","[{'ForeName': 'Syed Hasib Akhter', 'Initials': 'SHA', 'LastName': 'Faruqui', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Rajitha', 'Initials': 'R', 'LastName': 'Meka', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alaeddini', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Chengdong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shirinkam', 'Affiliation': 'Department of Mathematics and Statistics, University of the Incarnate Word, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/14452'] 790,32406553,Alcohol Cue-Induced Ventral Striatum Activity Predicts Subsequent Alcohol Self-Administration.,"BACKGROUND Human laboratory paradigms are a pillar in medication development for alcohol use disorders (AUD). Neuroimaging paradigms, in which individuals are exposed to cues that elicit neural correlates of alcohol craving (e.g., mesocorticolimbic activation), are increasingly utilized to test the effects of AUD medications. Elucidation of the translational effects of these neuroimaging paradigms on human laboratory paradigms, such as self-administration, is warranted. The current study is a secondary analysis examining whether alcohol cue-induced activation in the ventral striatum is predictive of subsequent alcohol self-administration in the laboratory. METHODS Non-treatment-seeking heavy drinkers of East Asian descent (n = 41) completed a randomized, placebo-controlled, double-blind, crossover experiment on the effects of naltrexone on neuroimaging and human laboratory paradigms. Participants completed 5 days of study medication (or placebo); on day 4, they completed a neuroimaging alcohol taste cue-reactivity task. On the following day (day 5), participants completed a 60-minute alcohol self-administration paradigm. RESULTS Multilevel Cox regressions indicated a significant effect of taste cue-elicited ventral striatum activation on latency to first drink, Wald χ 2  = 2.88, p = 0.05, such that those with higher ventral striatum activation exhibited shorter latencies to consume their first drink. Similarly, ventral striatum activation was positively associated with total number of drinks consumed, F(1, 38) = 5.90, p = 0.02. These effects were significant after controlling for alcohol use severity, OPRM1 genotype, and medication. Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. CONCLUSIONS Neuroimaging alcohol taste cue paradigms may be predictive of laboratory paradigms such as self-administration. Elucidation of the relationships among different paradigms will inform how these paradigms may be used synergistically in experimental medicine and medication development.",2020,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. ",['Non-treatment-seeking heavy drinkers of East Asian descent (n\xa0=\xa041'],"['naltrexone', 'placebo']","['taste cue-elicited ventral striatum activation', 'ventral striatum activation']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",41.0,0.0517698,"Other potential regions of interest (anterior cingulate, thalamus) were not predictive of self-administration outcomes. ","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Meredith', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Donato', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burnette', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (ACL, RG, ENG, AV, LRM, SD, EB, LAR), University of California, Los Angeles, Los Angeles, California, United States.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14342'] 791,31984589,Restoring body image after cancer (ReBIC): A group therapy intervention.,"OBJECTIVES Body image (BI) remains a significant survivorship challenge among breast cancer (BC) survivors. We describe an 8-week group intervention-restoring body image after cancer (ReBIC)-developed to target BI distress for BC survivors. METHODS The intervention was informed by interviews with BC survivors and by a descriptive, exploratory approach which adapted guided imagery exercises to address BI. Educational material was selected to address sociocultural factors that may contribute to BI distress and affect adjustment. Videotape reviews and content analyses further refined the intervention. RESULTS The intervention incorporates three active components: psychotherapeutic group principles; guided imagery exercises to address BI; and psychoeducation on relevant socialization factors and gender-based messages internalized by women in Western society. The therapeutic group was a supportive and effective way to assist BC survivors to gain insight on BI impacts, their histories, and relevant sociocultural factors contributing to BI distress. The group also facilitated the working through of grief over multiple losses. Guided imagery was well-received, and appeared to help survivors identify negative and emerging self-schema, as well as facilitate new self-views. Specific themes included negative emotions associated with an altered body and self, grief and loss, isolation, difficulties with sexual intimacy, relationship challenges, and uncertainty around sense of self and future. CONCLUSION An empirically tested group therapy intervention is described and has implications for survivorship programs to help address BI-related challenges. Future work could consider testing a similar approach tailored for other cancer populations.",2020,"The therapeutic group was a supportive and effective way to assist BC survivors to gain insight on BI impacts, their histories, and relevant sociocultural factors contributing to BI distress.",['breast cancer (BC) survivors'],['psychotherapeutic group principles; guided imagery exercises to address BI; and psychoeducation on relevant socialization factors and gender-based messages internalized by women in Western society'],"['negative emotions associated with an altered body and self, grief and loss, isolation, difficulties with sexual intimacy, relationship challenges, and uncertainty around sense of self and future']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0130064,"The therapeutic group was a supportive and effective way to assist BC survivors to gain insight on BI impacts, their histories, and relevant sociocultural factors contributing to BI distress.","[{'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Esplen', 'Affiliation': 'de Souza Institute, University Health Network, Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Warner', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Health Sciences Centre, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Boquiren', 'Affiliation': 'CBT Associates, Toronto, Ontario, Canada.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'de Souza Institute, University Health Network, Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Toner', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Psycho-oncology,['10.1002/pon.5304'] 792,31944474,Predictive factors for differential changes in grief symptoms following group bereavement intervention for Chinese widowed older adults.,"This study aimed to delineate changes in the patterns of prolonged grief severity in widowed adults following group bereavement interventions and to identify the predictive factors impacting these patterns. We performed a secondary analysis of data from a randomized trial of 125 Chinese widowed older adults who participated in either LOGBI or DPGBI. Self-ratings of prolonged grief symptoms via Inventory of Complicated Grief (ICG) were subjected to latent class growth analysis to identify subgroups according to symptomatic changes among baseline, post-treatment, and 8-week follow-up. Multinomial regression analysis examined whether participant classification could be predicted by demographics, loss-related characteristics, and the relationship with the deceased and baseline symptom severity. In the results, intervention sample comprised 96 completers with an attendance greater than 60%. A three-class categorization yielded the best model fit for changes in prolonged grief severity for both randomized and intervention samples: improved class (41.6% in the randomized sample, 42.8% in the intervention sample), partial responded class (48.1%/45.5%), and relapse class (10.3%/11.8%). Older widowed adults experiencing a high level of grief at baseline and bereavement following chronic illness had an elevated risk of symptomatic relapse after the completion of intervention. These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions. Practically, widowed adults with a higher risk of symptomatic relapse might need more intensive or longer term intervention or follow-up support.",2020,These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions.,"['125 Chinese widowed older adults who participated in either Loss-oriented or Dual Process group bereavement interventions', 'Chinese widowed older adults', '96 completers with an attendance greater than 60']",[],"['relapse class', 'symptomatic relapse', 'prolonged grief severity']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0206275', 'cui_str': 'Widowhood'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0835216,These findings indicated that Chinese widowed adults experienced different changing patterns of prolonged grief severity following group bereavement interventions.,"[{'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Amy Y M', 'Initials': 'AYM', 'LastName': 'Chow', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Suqin', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Sociology, Law School, Shenzhen University, Shenzhen, China.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2425'] 793,31985301,Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.,"Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion. Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis. Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of ""clear"" or ""almost clear,"" [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated. Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p  < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294). Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.",2020,"Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.","['adult patients with moderate-to-severe plaque psoriasis', 'moderate-to-severe plaque psoriasis', 'plaque psoriasis']","['calcipotriene 0.005% plus betamethasone dipropionate', 'tazarotene 0.045% (HP/TAZ', 'HP/TAZ lotion', 'Cal/BD foam vs HP/TAZ lotion', 'calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs halobetasol 0.01%/tazarotene 0.045% lotion']","['rate of treatment success, lower ICPR', 'rate of treatment success']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0053523', 'cui_str': 'betamethasone dipropionate'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C4517414', 'cui_str': '0.064 (qualifier value)'}, {'cui': 'C0082787', 'cui_str': 'halobetasol'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.0858623,"Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.","[{'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, CA, USA.'}, {'ForeName': 'Jes B', 'Initials': 'JB', 'LastName': 'Hansen', 'Affiliation': 'LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Dharm S', 'Initials': 'DS', 'LastName': 'Patel', 'Affiliation': 'LEO Pharma, Madison, NJ, USA.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Nyholm', 'Affiliation': 'LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Veverka', 'Affiliation': 'LEO Pharma, Madison, NJ, USA.'}, {'ForeName': 'Andrine R', 'Initials': 'AR', 'LastName': 'Swensen', 'Affiliation': 'LEO Pharma, Madison, NJ, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1722139'] 794,31923061,Ropivacaine and Ketorolac Wound Infusion for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the efficacy of wound infusion with ropivacaine plus ketorolac compared with placebo for post-cesarean delivery analgesia in women who received a multimodal analgesic regimen including intrathecal morphine. METHODS In a randomized double-blind study, women undergoing scheduled cesarean delivery under spinal or combined spinal epidural anesthesia were randomized to wound infusion with ropivacaine 0.2% plus ketorolac, or saline placebo using an elastometric pump for 48 hours. The primary outcome was pain score with movement at 24 hours after surgery (0-10 scale, 0=no pain and 10=worst possible pain). Secondary outcomes included pain scores at rest at 24 hours, pain scores at rest and with movement at 2 and 48 hours, opioid consumption, and time to first rescue analgesic. A sample size of 35 per group (n=70) was planned. RESULTS From November 8, 2016, to May 17, 2019, 247 women were screened, and 71 completed the study per protocol: 38 in the placebo group and 33 in the ropivacaine plus ketorolac group. Patient demographics and intraoperative characteristics were comparable between the groups. There was no significant difference between the groups in the primary outcome of pain score with movement at 24 hours (difference in median score 0, 95% CI -1 to 2, P=.94). There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). CONCLUSION There was no benefit of wound infusion with ropivacaine and ketorolac in women who received intrathecal morphine and a multimodal analgesic regimen. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02829944. FUNDING SOURCE The study was supported in part by Avanos Medical Inc.",2020,"There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). ","['women who received a multimodal analgesic regimen including intrathecal morphine', 'Post-Cesarean Delivery Analgesia', 'women undergoing scheduled cesarean delivery under spinal or combined spinal epidural anesthesia', 'From November 8, 2016, to May 17, 2019, 247 women were screened, and 71 completed the study per protocol: 38 in the placebo group and 33 in the']","['Ropivacaine', 'ropivacaine 0.2% plus ketorolac, or saline placebo', 'intrathecal morphine', 'placebo', 'ketorolac', 'ropivacaine', 'Ketorolac Wound Infusion', 'ropivacaine plus ketorolac']","['pain scores', 'total opioid consumption', 'pain score', 'pain scores at rest at 24 hours, pain scores at rest and with movement at 2 and 48 hours, opioid consumption, and time to first rescue analgesic', 'pain score with movement at 24 hours after surgery (0-10 scale, 0=no pain and 10=worst possible pain', 'time to rescue analgesics', 'Patient demographics and intraoperative characteristics']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",247.0,0.785805,"There were also no significant differences between the placebo and ropivacaine plus ketorolac groups in pain scores at other time points, in total opioid consumption (difference in median consumption -12.5 mg, 95% CI -30 to 5, P=.11), or in time to rescue analgesics (median [interquartile range] 660 [9-1,496] vs 954 [244-1,710] minutes, hazard ratio 0.69, 95% CI 0.41 to 1.17, P=.16). ","[{'ForeName': 'Emily Z', 'Initials': 'EZ', 'LastName': 'Barney', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; the Anesthesia Medical Group, Inc., Nashville, Tennessee; and the Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Christina D', 'Initials': 'CD', 'LastName': 'Pedro', 'Affiliation': ''}, {'ForeName': 'Brock H', 'Initials': 'BH', 'LastName': 'Gamez', 'Affiliation': ''}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Fuller', 'Affiliation': ''}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Dominguez', 'Affiliation': ''}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Habib', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003601'] 795,31923066,Effect of Surgery for Stress Incontinence on Female Sexual Function.,"OBJECTIVE To evaluate the effects of four different surgical interventions for stress urinary incontinence (SUI) on 2-year postoperative sexual function. METHODS This is a combined secondary analysis of SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings). Women in the original trials were randomized to receive surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function (assessed by the short version of the PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire]) was compared between groups at baseline, 12 and 24 months. Secondarily, the effects of subjective and objective surgical cure rates and the effect of concomitant surgical procedures on 24-month sexual function was explored. RESULTS Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed. Baseline characteristics (including PISQ-12 scores) were similar between the four treatment arms, with notable exceptions including race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries. After adjustment for differences between the groups, there was a clinically important improvement in PISQ-12 scores over the 24-month postoperative period for all treatment groups, with no significant differences attributed to the type of anti-incontinence procedure (baseline PISQ-12: 32.6, 33.1, 31.9, 31.4; 24-month PISQ-12: 37.7, 37.8, 36.9, 37.1, P<.01). There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97). Multivariable analysis showed independent associations between objective and subjective cure rates as well as concomitant procedures with a 24-month PISQ-12 score. CONCLUSION Women undergoing anti-incontinence surgery show overall improvement in sexual function from baseline to 24 months postoperatively, without significant differences based on surgical procedure performed. The majority of this improvement occurs in the first 12 months and is maintained over 24 months.",2020,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","['Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed', 'Stress Incontinence on Female Sexual Function']","['surgical interventions', 'TOMUS', 'surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS', 'Surgery', 'concomitant surgical procedures']","['mean PISQ-12 scores', 'Sexual function', 'PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire', 'objective and subjective cure rates', 'Baseline characteristics (including PISQ-12 scores', 'PISQ-12 scores', 'type of anti-incontinence procedure', 'race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries', 'sexual function', '24-month sexual function']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}]","[{'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",924.0,0.049267,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Glass Clark', 'Affiliation': 'Department of Obstetrics and Gynecology and the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Virginia Commonwealth University Health System, and the Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Sima', 'Affiliation': ''}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Siff', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003648'] 796,31923073,Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial.,"OBJECTIVE To evaluate outcomes after pelvic floor muscle therapy, as compared with perineorrhaphy and distal posterior colporrhaphy, in the treatment of women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum. METHODS We performed a single center, open-label, randomized controlled trial. After informed consent, patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum were randomized to either surgery or physical therapy. The primary outcome was treatment success, as defined by Patient Global Impression of Improvement, at 6 months. Secondary outcomes included the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale. Assuming a 60% treatment success in the surgery group and 20% in the physical therapy group, plus anticipating a 20% loss to follow-up, a total of 70 patients needed to be recruited. RESULTS From October 2015 to June 2018, 70 of 109 eligible patients were randomized, half into surgery and half into tutored pelvic floor muscle therapy. The median age of the study group was 35 years, and the median duration postpartum at enrollment in the study was 10 months. There were three dropouts in the surgery group postrandomization. In an intention-to-treat analysis, with worst case imputation of missing outcomes, subjective global improvement was reported by 25 of 35 patients (71%) in the surgery group compared with 4 of 35 patients (11%) in the physical therapy group (treatment effect in percentage points 60% [95% CI 42-78%], odds ratio 19 [95% CI 5-69]). The surgery group was superior to physical therapy regarding all secondary endpoints. CONCLUSION Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02545218.",2020,"Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. ","['From October 2015 to June 2018, 70 of 109 eligible patients', 'Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear', 'patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum', 'women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum']","['surgery or physical therapy', 'Pelvic Floor Muscle Therapy', 'pelvic floor muscle therapy', 'pelvic floor muscle training', 'perineorrhaphy and distal posterior colporrhaphy', 'Perineorrhaphy']","['treatment success, as defined by Patient Global Impression of Improvement', 'subjective global improvement', 'median duration postpartum', 'Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205169', 'cui_str': 'Bad (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0240713', 'cui_str': 'Laceration of perineum (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0031064', 'cui_str': 'Perineorrhaphy (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina (procedure)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}]",109.0,0.139692,"Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum. ","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Bergman', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and the Division of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Westergren Söderberg', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ek', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003653'] 797,31923074,Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial.,"OBJECTIVE To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine. METHODS In a single-site randomized trial, patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine-prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N=106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019. RESULTS From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine-prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine-prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine-prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [-45.1 to -6.3]; P<.01). Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). CONCLUSION Lidocaine-prilocaine cream before vulvar biopsy resulted in a lower maximum pain score and a significantly better patient rating of the biopsy experience when compared with lidocaine injection. Lidocaine-prilocaine cream, alone, is a reasonable option to use for vulvar biopsy. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03654417.",2020,"Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). ","['patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare', 'From October 2018 to March 2019, 38 patients completed informed consent and were randomized', 'Vulvar Biopsy', 'Participants were women with median age of 60 years', '53 participants in each arm (N=106) was planned']","['lidocaine-prilocaine cream or injection of 1% lidocaine', 'lidocaine-prilocaine', 'lidocaine injection', 'Lidocaine-Prilocaine Cream', 'lidocaine-prilocaine cream', 'Lidocaine', 'lidocaine', 'Lidocaine-prilocaine cream']","['Pain', 'pain score at biopsy, patient experience, and tolerability and acceptability', 'median highest pain score', 'maximum pain score', 'highest pain score', 'baseline vulvar pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1744618', 'cui_str': 'Biopsy of vulva (procedure)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine / Prilocaine'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4081145', 'cui_str': 'Lidocaine Injection [Xylocaine]'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",53.0,0.27322,"Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). ","[{'ForeName': 'Logan K', 'Initials': 'LK', 'LastName': 'Williams', 'Affiliation': 'Department of Obstetrics and Gynecology, and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, and the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Pieper', 'Affiliation': ''}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Lorenzo', 'Affiliation': ''}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Havrilesky', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003660'] 798,30880108,"Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results.","PURPOSE Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG). DESIGN Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial. PARTICIPANTS Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery. METHODS After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n = 387) or no stent implantation (control group, n = 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed. MAIN OUTCOME MEASURES Effectiveness end points were ≥20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events. RESULTS The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P = 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP ≤18 mmHg (difference 13.2%; 95% confidence interval, 2.9-23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. CONCLUSIONS Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.",2019,"The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. ","['After uncomplicated cataract surgery, eyes', 'subjects with mild to moderate primary open-angle glaucoma (POAG', 'Primary Open-Angle Glaucoma and Cataract', 'Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery']","['ab interno implanted (iStent inject', 'Trabecular Micro-Bypass System ', 'cataract surgery versus cataract surgery alone', 'Ab Interno Implanted Trabecular Micro-Bypass', 'ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n\xa0= 387) or no stent implantation', 'cataract surgery']","['medicated IOP', 'overall safety profile', 'unmedicated DIOP', 'safety and effectiveness', 'spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0018071', 'cui_str': 'Gonioscopy'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0427809,"The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up. ","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Samuelson', 'Affiliation': 'Minnesota Eye Consultants, Minneapolis, Minnesota. Electronic address: twsamuelson@mneye.com.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Sarkisian', 'Affiliation': 'Dean McGee Eye Institute, Oklahoma City, Oklahoma.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lubeck', 'Affiliation': 'Arbor Centers for EyeCare, Homewood, Illinois.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Stiles', 'Affiliation': 'Stiles Eyecare Excellence and Glaucoma Institute PA, Overland Park, Kansas.'}, {'ForeName': 'Yi-Jing', 'Initials': 'YJ', 'LastName': 'Duh', 'Affiliation': 'StatServ Consulting Inc, Chino Hills, California.'}, {'ForeName': 'Eeke A', 'Initials': 'EA', 'LastName': 'Romo', 'Affiliation': 'ClinReg Consulting Services, Laguna Beach, California.'}, {'ForeName': 'Jane Ellen', 'Initials': 'JE', 'LastName': 'Giamporcaro', 'Affiliation': 'Glaukos Corporation, San Clemente, California.'}, {'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Hornbeak', 'Affiliation': 'Glaukos Corporation, San Clemente, California.'}, {'ForeName': 'L Jay', 'Initials': 'LJ', 'LastName': 'Katz', 'Affiliation': 'Glaukos Corporation, San Clemente, California; Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.03.006'] 799,31973991,Biomechanical Evaluation of Humerus Fracture After Subpectoral Biceps Tenodesis With Interference Screw Versus Unicortical Button.,"PURPOSE To compare the torsional failure strength of the humerus after subpectoral biceps tenodesis with an interference screw versus a unicortical button in a human cadaveric model. METHODS Thirteen matched pairs of fresh-frozen human cadaveric upper extremities were randomized to receive either 2.6 × 12 mm unicortical button or 6.25-mm interference screw subpectoral biceps tenodesis. After the procedure, the humeri were loaded into a materials testing machine. The humeri were loaded in external rotation with respect to the elbow at 1.0°/s until failure. Rotation angle to failure, failure torque, energy absorbed, and stiffness were compared by paired t-tests with alpha set at 0.05. RESULTS Humeri that were fixed with unicortical buttons showed statistically significant higher rotation to failure (26.87 ± 5.83 vs 19.04 ± 3.86°, P < .001), failure torque (54.11 ± 22.01 vs 44.95 ± 17.47 Nm, P < .001), and energy absorbed (883.93 ± 582.28 vs 451.40 ± 216.19 Nm-Deg, P = .002) than humeri fixed with interference screws. CONCLUSIONS In a cadaveric biomechanical model, at time 0, the use of a 2.7 × 12-mm unicortical button fixation in biceps tenodesis resulted in higher loads required to fracture the humerus when compared with a 6.25-mm interference screw fixation in a torsion model. CLINICAL RELEVANCE This study demonstrates a significant biomechanical difference with regards to fracture of the humerus, between 2 commonly used fixations methods and implant sizes, interference screw, and unicortical button. The results of this study can aid surgeons in implant selection as well as help to improve patient education prior to surgery.",2020,"RESULTS Humeri that were fixed with unicortical buttons showed statistically significant higher rotation to failure (26.87 ± 5.83 vs 19.04 ± 3.86°, P < .001), failure torque (54.11 ± 22.01 vs 44.95 ± 17.47 Nm, P < .001), and energy absorbed (883.93 ± 582.28 vs 451.40 ± 216.19",['Thirteen matched pairs of fresh-frozen human cadaveric upper extremities'],"['Interference Screw Versus Unicortical Button', 'subpectoral biceps tenodesis with an interference screw versus a unicortical button', '2.6\xa0× 12 mm unicortical button or 6.25-mm interference screw subpectoral biceps tenodesis']","['failure torque', 'rotation to failure', 'Rotation angle to failure, failure torque, energy absorbed, and stiffness', 'torsional failure strength']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C4517821', 'cui_str': '6.25'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0450425', 'cui_str': 'Torsional (qualifier value)'}]",13.0,0.0676218,"RESULTS Humeri that were fixed with unicortical buttons showed statistically significant higher rotation to failure (26.87 ± 5.83 vs 19.04 ± 3.86°, P < .001), failure torque (54.11 ± 22.01 vs 44.95 ± 17.47 Nm, P < .001), and energy absorbed (883.93 ± 582.28 vs 451.40 ± 216.19","[{'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Khalid', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, Texas, U.S.A.'}, {'ForeName': 'Randal P', 'Initials': 'RP', 'LastName': 'Morris', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, Texas, U.S.A.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Black', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, The University of Texas Medical Branch, Galveston, Texas, U.S.A.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Maassen', 'Affiliation': 'Inov8 Orthopedics, Houston, Texas, U.S.A.. Electronic address: nickmaass@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.10.034'] 800,31973838,"Re: Hutnik et al.: Selective laser trabeculoplasty versus argon laser trabeculoplasty in glaucoma patients treated previously with 360° selective laser trabeculoplasty: a randomized, single-blind, equivalence clinical trial (Ophthalmology. 2019;126:223-232).",,2020,,['glaucoma patients treated previously with 360°'],"['laser trabeculoplasty versus argon laser trabeculoplasty', 'selective laser trabeculoplasty']",[],"[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0395482', 'cui_str': 'LTP - laser trabeculoplasty'}, {'cui': 'C1319234', 'cui_str': 'Argon laser trabeculoplasty'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]",[],,0.0409616,,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Realini', 'Affiliation': 'West Virginia University, Morgantown, West Virginia. Electronic address: realinia@wvuhealthcare.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.10.012'] 801,31975053,Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults.,"Chronic calorie restriction (CR) improves cardiovascular function and several other physiological markers of healthspan. However, CR is impractical in non-obese older humans due to potential loss of lean mass and bone density, poor adherence, and risk of malnutrition. Time-restricted feeding (TRF), which limits the daily feeding period without requiring a reduction in calorie intake, may be a promising alternative healthspan-extending strategy for midlife and older adults; however, there is limited evidence for its feasibility and efficacy in humans. We conducted a randomized, controlled pilot study to assess the safety, tolerability, and overall feasibility of short-term TRF (eating <8 h day -1 for 6 weeks) without weight loss in healthy non-obese midlife and older adults, while gaining initial insight into potential efficacy for improving cardiovascular function and other indicators of healthspan. TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake. Cardiovascular function was not enhanced by short-term TRF in this healthy cohort, but functional (endurance) capacity and glucose tolerance were modestly improved. These results provide a foundation for conducting larger clinical studies of TRF in midlife and older adults, including trials with a longer treatment duration.",2020,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","['non-obese healthy midlife and older adults', 'healthy non-obese midlife and older adults', 'midlife and older adults']","['Chronic calorie restriction (CR', 'TRF', 'short-term TRF (eating <8\xa0h\xa0day -1 for 6\xa0weeks) without weight loss', 'Time-restricted feeding (TRF', 'Short-term time-restricted feeding']","['Cardiovascular function', 'functional (endurance) capacity and glucose tolerance', 'safe and well-tolerated', 'safety, tolerability, and overall feasibility', 'lean mass, bone density, or nutrient intake', 'cardiovascular function']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.0344111,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA. cmartens@udel.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Rossman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Mazzo', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Jankowski', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Erzsebet E', 'Initials': 'EE', 'LastName': 'Nagy', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Blair A', 'Initials': 'BA', 'LastName': 'Denman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Richey', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Ziemba', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Innovative Design & Analysis, University of Colorado School of Public Health, Aurora, CO, 80045, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}]",GeroScience,['10.1007/s11357-020-00156-6'] 802,32406655,Three-Dimensional Volumetric Changes After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix.,"PURPOSE Socket augmentation decreases the magnitude of alveolar ridge resorption, but the literature is limited in respect to quantifying soft tissue remodeling. The aim of this study was to determine the volumetric and linear dimensional changes at the buccal surface for both hard and soft tissues after socket augmentation treated with a xenogeneic collagen matrix in combination with bone grafting. MATERIALS AND METHODS Twenty-four individuals indicated for tooth extraction were enrolled in this investigation. Each participant was randomly assigned to one of two groups: (1) deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix. A cone beam computed tomography scan was taken prior to extraction and at 6 months postextraction. Intraoral scanning images were taken at baseline, 3 months, and 6 months postextraction. Hard and soft tissue analyses were performed to compare linear ridge remodeling and volumetric changes by noncontact reverse-engineering software. RESULTS Both groups showed bone and soft tissue remodeling. For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups. For soft tissue remodeling, the collagen matrix group showed a reduced soft tissue loss compared with the collagen plug group. The volumetric analysis demonstrated that the mean buccal soft tissue volume loss for the collagen matrix group was 68.6 mm 3 compared with 87.6 mm 3 found in the collagen plug group (P = .009) over a 6-month period. CONCLUSION This clinical investigation provides early evidence of using the total tissue volume to compare soft and hard tissue remodeling after socket augmentation. The results of this study demonstrated that the use of a xenogeneic collagen matrix reduced the buccal soft tissue loss after tooth extraction, but additional studies are necessary to evaluate the clinical significance of soft tissue augmentation after tooth extraction.",2020,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.",['Twenty-four individuals indicated for tooth extraction were enrolled in this investigation'],"['Deproteinized Bovine Bone and Collagen Matrix', 'xenogeneic collagen matrix', 'deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix']","['mean buccal soft tissue volume loss', 'alveolar ridge resorption', 'soft tissue loss', 'bone and soft tissue remodeling', 'buccal soft tissue loss']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0182324', 'cui_str': 'Plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",24.0,0.0170066,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marchesan', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7961'] 803,31969545,Randomized clinical trial of five adhesive systems in occlusal restorations: One-year results.,"This randomized clinical trial evaluated the efficacy of five different adhesive systems in the restoration of occlusal cavities after one year of function. Two etch-and-rinse (Optibond™FL, Prime&Bond ® NT™) and three self-etch (Clearfil™SE Bond, Xeno ® III, Xeno ® V + ) adhesive systems were evaluated on 159 occlusal restorations, incrementally filled with a microhybrid composite resin. Restorations were assessed using the FDI criteria at baseline, 6 months and 1 year. Statistical analysis was performed with Friedman-test and Kruskal-Wallis test (p<0.05). At 1 year, 153 restorations were evaluated. A statistically significant decrease in the number of restorations with marginal adaptation classified as excellent occurred for the self-etch adhesives (p<0.01). Etch-and-rinse adhesives presented better performance than any of the self-etch systems (p<0.01) in terms of marginal adaptation. All cases were considered no less than satisfactory. Marginal adaptation was the most influent parameter on the distinctive performance of the adhesives where etch-and-rinse systems performed significantly better than self-etch systems.",2020,A statistically significant decrease in the number of restorations with marginal adaptation classified as excellent occurred for the self-etch adhesives (p<0.01).,"['159 occlusal restorations, incrementally filled with a microhybrid composite resin', 'occlusal restorations']","['Two etch-and-rinse (Optibond™FL, Prime&Bond ® NT™) and three self-etch (Clearfil™SE Bond, Xeno ® III, Xeno ® V + ']",['number of restorations with marginal adaptation classified'],"[{'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0296330', 'cui_str': 'Optibond'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]",159.0,0.0640897,A statistically significant decrease in the number of restorations with marginal adaptation classified as excellent occurred for the self-etch adhesives (p<0.01).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vinagre', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Ramos', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marques', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Chambino', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Messias', 'Affiliation': 'Dentistry Department, Faculty of Medicine, University of Coimbra.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Mata', 'Affiliation': 'School of Dental Medicine, Lisbon University.'}]",Dental materials journal,['10.4012/dmj.2019-011'] 804,31353666,"Metabolic status is related to the effects of adding of sacha inchi (Plukenetia volubilis L.) oil on postprandial inflammation and lipid profile: Randomized, crossover clinical trial.","Sacha inchi oil (SIO) is an attractive source of polyunsaturated acids oil. A randomized crossover clinical trial was done to evaluate SIO effects on postprandial lipids and inflammatory state caused by a high-fat intake. Twenty metabolically healthy (MH) and 22 metabolically unhealthy (MU) subjects consumed a high-fat breakfast alone or supplemented with SIO. The biomarkers were measured in serum upon fasting, and after 1 and 4 hrs after breakfast. Interleukin-6 (IL-6) expression was determined in mononuclear cells. In the MH group, SIO reversed the cholesterol increase [iAUC HFM : 0.27 mmol/L/4 h (IQR: -0.07/0.81); iAUC HFM+S : -0.18 mmol/L/4 h (IQR: -0.49/0.31) p = 0.037] and decreased interleukin-6 concentration. In MU group, SIO attenuated lipopolysaccharides increase and interleukin-6 expression [(FC HFM  = -1.19 (IQR: -1.72/1.93) and FC HFM+S  = -1.83 (IQR: -4,82/-0.01), p = 0.017]. The effects of a high-fat meal on postprandial lipids and inflammation could be modified by the addition of SIO, but the outcomes are depending on the metabolic individual status. PRACTICAL APPLICATIONS: The seeds of Plukenetia volubilis L., also known as Sacha inchi, Sacha peanut or Inca peanut are an attractive vegetable source of oil which includes a high content of polyunsaturated fatty acids. Furthermore, the intake of Sacha inchi oil could improve the postprandial responses of a high-fat intake, and could be able to help to prevent cardiovascular diseases. Our results contribute to know the effects of this oil on postprandial inflammation and lipids. In addition, establishing how a person's basal metabolic status can determinate the metabolic response to this oil can help improve its use, and our results add evidence about the role of nutrition and diet in health and disease. At this time, the cultivation of Sacha inchi is being proposed as an agro-industrial alternative for the improvement of quality of living in Colombian rural areas.",2019,"In MU group, SIO attenuated lipopolysaccharides increase and interleukin-6 expression [(FC HFM  = -1.19",['Twenty metabolically healthy (MH) and 22 metabolically unhealthy (MU) subjects consumed a'],"['Sacha inchi oil (SIO', 'high-fat breakfast alone or supplemented with SIO', 'high-fat meal', 'sacha inchi (Plukenetia volubilis L.) oil']","['postprandial lipids and inflammatory state', 'Interleukin-6 (IL-6) expression', 'postprandial lipids and inflammation', 'interleukin-6 expression', 'interleukin-6 concentration']",[],"[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0292631,"In MU group, SIO attenuated lipopolysaccharides increase and interleukin-6 expression [(FC HFM  = -1.19","[{'ForeName': 'Alicia Norma', 'Initials': 'AN', 'LastName': 'Alayón', 'Affiliation': 'Universidad de San Buenaventura - Cartagena - Facultad de Ciencias de la Salud - Grupo de Investigaciones Biomédicas (GIB), Cartagena, Colombia.'}, {'ForeName': 'José Guillermo', 'Initials': 'JG', 'LastName': 'Ortega Ávila', 'Affiliation': 'Departamento Ciencias Básicas de Salud, Pontificia Universidad Javeriana, Cali, Colombia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Echeverri Jiménez', 'Affiliation': 'Universidad Icesi, Facultad de Ciencias de la Salud, Cali, Colombia.'}]",Journal of food biochemistry,['10.1111/jfbc.12703'] 805,30676382,"Intravenous Patient-controlled Analgesia Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial.","OBJECTIVE We conducted a randomized, controlled, noninferiority trial to investigate if intravenous, multimodal, patient-controlled analgesia (IV-PCA) could be noninferior to multimodal thoracic epidural analgesia (TEA) in patients undergoing open liver surgery. SUMMARY BACKGROUND DATA The increasing use of minimally invasive techniques and fast track protocols have questioned the position of epidural analgesia as the optimal method of pain management after abdominal surgery. METHODS Patients operated with open liver resection between February 2012 and February 2016 were randomly assigned to receive either IV-PCA enhanced with ketorolac/diclofenac (IV-PCA, n = 66) or TEA (n = 77) within an enhanced recovery after surgery protocol. Noninferiority would be declared if the mean pain score on the numeric rating scale (NRS) for postoperative days (PODs) 0 to 5 in the IV-PCA group was no worse than the mean pain score in the TEA group by a margin of <1 point on an 11-point scale (0-10). RESULTS The primary endpoint, mean NRS pain score was 1.7 in the IV-PCA group and 1.6 in the TEA group, establishing noninferiority. Pain scores were lower in the TEA group on PODs 0 and 1, but higher or equal on PODs 2 and 5. Postoperative hospital stay was significantly shorter for patients in the IV-PCA group (74 vs 104 h, P < 0.001). The total opioid consumption during the first 3 days was significantly lower in the IV-PCA group. CONCLUSIONS IV-PCA was noninferior to TEA for the treatment of postoperative pain in patients undergoing open liver resection.",2019,"Postoperative hospital stay was significantly shorter for patients in the IV-PCA group (74 vs 104 h, P < 0.001).","['Patients operated with open liver resection between February 2012 and February 2016', 'patients undergoing open liver resection', 'patients undergoing open liver surgery']","['TEA', 'multimodal, patient-controlled analgesia (IV-PCA', 'IV-PCA enhanced with ketorolac/diclofenac (IV-PCA, n = 66) or TEA', 'Intravenous Patient-controlled Analgesia Versus Thoracic Epidural Analgesia', 'multimodal thoracic epidural analgesia (TEA']","['postoperative pain', 'Postoperative hospital stay', 'total opioid consumption', 'mean NRS pain score', 'mean pain score', 'Pain scores', 'numeric rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}]",,0.114621,"Postoperative hospital stay was significantly shorter for patients in the IV-PCA group (74 vs 104 h, P < 0.001).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hausken', 'Affiliation': 'Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Åsmund Avdem', 'Initials': 'ÅA', 'LastName': 'Fretland', 'Affiliation': 'The Intervention Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': 'The Intervention Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marit Helen', 'Initials': 'MH', 'LastName': 'Andersen', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Vegar Johansen', 'Initials': 'VJ', 'LastName': 'Dagenborg', 'Affiliation': 'Department of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gudrun Maria Waaler', 'Initials': 'GMW', 'LastName': 'Bjørnelv', 'Affiliation': 'The Intervention Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Kristiansen', 'Affiliation': 'The Intervention Centre, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Røysland', 'Affiliation': 'Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gunnvald', 'Initials': 'G', 'LastName': 'Kvarstein', 'Affiliation': 'Department of Clinical Medicine, UiT, The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Tor Inge', 'Initials': 'TI', 'LastName': 'Tønnessen', 'Affiliation': 'Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}]",Annals of surgery,['10.1097/SLA.0000000000003209'] 806,31969547,Suppression of root caries progression by application of Nanoseal ® : A single-blind randomized clinical trial.,"The aim of this single-blind, parallel and randomized controlled trial was to evaluate the effect of Nanoseal ® application on root caries progression. Adult patients (n=129, mean age: 66.4±10.1 years) with root caries were randomly allocated into three groups: high-frequency (HF, n=43; intervention: Nanoseal application at baseline and 1-5 months), low-frequency (LF, n=43; intervention: Nanoseal application at baseline and 3 months), and control (n=43; intervention: no application of Nanoseal) groups. Measurements of fluorescence laser values of carious lesions using a DIAGNOdent™ Pen (D-value) were performed for each subject before intervention (baseline) and at 3 and 6 months. Significantly lower D-values for the HF (p=0.017) and LF (p=0.034) groups were observed compared with the control group at 6 months. Nanoseal application would be an effective procedure to suppress root caries progression.",2020,Significantly lower D-values for the HF (p=0.017) and LF (p=0.034) groups were observed compared with the control group at 6 months.,"['Adult patients (n=129, mean age: 66.4±10.1 years) with root caries']","['high-frequency (HF, n=43; intervention: Nanoseal application at baseline and 1-5 months), low-frequency (LF, n=43; intervention: Nanoseal application at baseline and 3 months), and control (n=43; intervention: no application of Nanoseal', 'Nanoseal ® ', 'Nanoseal ® application']",['root caries progression'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0162644', 'cui_str': 'Root Caries'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C3850443', 'cui_str': 'Nanoseal'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0162644', 'cui_str': 'Root Caries'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0370755,Significantly lower D-values for the HF (p=0.017) and LF (p=0.034) groups were observed compared with the control group at 6 months.,"[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Miyaji', 'Affiliation': 'Clinic of Endodontics and Periodontics, Hokkaido University Hospital.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kato', 'Affiliation': 'Department of Periodontology and Endodontology, Faculty of Dental Medicine, Hokkaido University.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Periodontology and Endodontology, Faculty of Dental Medicine, Hokkaido University.'}]",Dental materials journal,['10.4012/dmj.2019-038'] 807,31941548,Tobacco and electronic cigarette cues for smoking and vaping: an online experimental study.,"OBJECTIVE This study examined whether exposure to smoking and vaping cues the urge to smoke or vape. It extends previous studies on first-generation cigalikes (visually similar to cigarettes) and second-generation devices (visually similar to pens) by including third-generation tank system devices (larger bulky units). In an online experiment, participants were randomly assigned to view one of four videos, which included smoking, vaping (cigalike or tank system), or neutral cues. The primary outcome was urge to smoke. Secondary outcomes were urge to vape, desire to smoke and vape, and intention to quit or remain abstinent from smoking. RESULTS UK adults varying in smoking (current or former) and vaping (user or non-user) status (n = 1120) completed the study: 184 (16%) failed study attention checks meaning 936 were included in the final analysis. Urges to smoke were similar across cue groups. Urges to vape were higher following exposure to vaping compared to neutral cues. There was no clear evidence of an interaction between cue group and smoking or vaping status. The lack of cueing effects on smoking urges is inconsistent with previous research, raising questions about the ability to assess craving in online settings.",2020,Urges to vape were higher following exposure to vaping compared to neutral cues.,['UK adults varying in smoking (current or former) and vaping (user or non-user) status (n\u2009=\u20091120) completed the study: 184 (16%) failed study attention checks meaning 936 were included in the final analysis'],"['Tobacco and electronic cigarette cues', 'included smoking, vaping (cigalike or tank system), or neutral cues']","['urge to smoke', 'urge to vape, desire to smoke and vape, and intention to quit or remain abstinent from smoking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0336821', 'cui_str': 'Tank - military vehicle (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",936.0,0.0364011,Urges to vape were higher following exposure to vaping compared to neutral cues.,"[{'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK. anna.blackwell@bristol.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Brocklebank', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': 'Department of Psychiatry, Cambridgeshire and Peterborough NHS Foundation Trust, University of Cambridge, Douglas House, Cambridge, CB2 8AH, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School: Population Health Sciences, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}]",BMC research notes,['10.1186/s13104-020-4899-3'] 808,31609787,"OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females.","This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs. placebo for major depressive disorder (MDD) [NCT02116361]. Primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS); secondary endpoints were Clinical Global Impressions-Severity and 17-item Hamilton Depression Rating Scale at week 6. A total of 255 adult females were treated. OnabotA 30 U approached significance compared to placebo on MADRS (mixed-effect model repeated measures least-squares mean difference: -3.7; P = 0.053) and reached significance [least-squares mean differences: -3.6 to -4.2; P < 0.05 (two-sided)] at weeks 3 and 9. Secondary endpoints were also significant at several time points. At week 6, onabotA 50 U did not separate from placebo in any parameters. OnabotA was generally well-tolerated: the only treatment-emergent adverse events reported in ≥5% in either onabotA group, and more than matching placebo were headache, upper respiratory infection, and eyelid ptosis. OnabotA 30 U, administered in a standardized injection pattern in a single session, had a consistent efficacy signal across multiple depression symptom scales for 12 or more weeks. OnabotA 30 U/placebo MADRS differences of (observed ANCOVA) ≥4.0 points (up to week 15) and ≥2.0 points (weeks 18-24) agree with the 2-point change threshold considered clinically relevant in MDD. OnabotA is a local therapy and is not commonly associated with systemic effects of conventional antidepressants and may represent a novel treatment option for MDD.",2020,"OnabotA was generally well-tolerated: the only treatment-emergent adverse events reported in ≥5% in either onabotA group, and more than matching placebo were headache, upper respiratory infection, and eyelid ptosis.","['adult females', 'major depressive disorder', '255 adult females', 'major depressive disorder (MDD']","['placebo', 'OnabotulinumtoxinA', 'onabotulinumtoxinA (onabotA; BOTOX) vs. placebo']","['headache, upper respiratory infection, and eyelid ptosis', 'MADRS', 'change in Montgomery-Åsberg Depression Rating Scale (MADRS); secondary endpoints were Clinical Global Impressions-Severity and 17-item Hamilton Depression Rating Scale', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0700702', 'cui_str': 'Botox'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0005745', 'cui_str': 'Ptosis, Eyelid'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",255.0,0.557133,"OnabotA was generally well-tolerated: the only treatment-emergent adverse events reported in ≥5% in either onabotA group, and more than matching placebo were headache, upper respiratory infection, and eyelid ptosis.","[{'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan, Irvine, California.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Durgam', 'Affiliation': 'Former Allergan Employee, Madison, New Jersy.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Lum', 'Affiliation': 'Allergan, Irvine, California.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'James', 'Affiliation': 'Allergan, Irvine, California.'}, {'ForeName': 'Jeen', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Allergan, Irvine, California.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'Allergan, Madison, New Jersy, USA.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000290'] 809,31672939,Salt increases monocyte CCR2 expression and inflammatory responses in humans.,"Inflammation may play a role in the link between high salt intake and its deleterious consequences. However, it is unknown whether salt can induce proinflammatory priming of monocytes and macrophages in humans. We investigated the effects of salt on monocytes and macrophages in vitro and in vivo by performing a randomized crossover trial in which 11 healthy human subjects adhered to a 2-week low-salt and high-salt diet. We demonstrate that salt increases monocyte expression of CCR2, a chemokine receptor that mediates monocyte infiltration in inflammatory diseases. In line with this, we show a salt-induced increase of plasma MCP-1, transendothelial migration of monocytes, and skin macrophage density after high-salt diet. Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet. Taken together, our data open up the possibility for inflammatory monocyte and macrophage responses as potential contributors to the deleterious effects of high salt intake.",2019,"Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet.","['11 healthy human subjects adhered to a 2-week low-salt and high-salt diet', 'humans']",[],"['monocyte CCR2 expression and inflammatory responses', 'cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages', 'plasma MCP-1, transendothelial migration of monocytes, and skin macrophage density']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2936223', 'cui_str': 'Endothelial Transmigration'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",11.0,0.0109655,"Macrophages demonstrate signs of an increased proinflammatory phenotype after salt exposure, as represented by boosted LPS-induced cytokine secretion of IL-6, TNF, and IL-10 in vitro, and by increased HLA-DR expression and decreased CD206 expression on skin macrophages after high-salt diet.","[{'ForeName': 'Eliane Fe', 'Initials': 'EF', 'LastName': 'Wenstedt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Sanne Gs', 'Initials': 'SG', 'LastName': 'Verberk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Molecular Cell Biology and Immunology, Amsterdam Cardiovascular Sciences, Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Experimental Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Annette E', 'Initials': 'AE', 'LastName': 'Neele', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Baardman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Nike', 'Initials': 'N', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Pathology, Amsterdam, Netherlands.'}, {'ForeName': 'Özge T', 'Initials': 'ÖT', 'LastName': 'Pasaoglu', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rademaker', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Esmee M', 'Initials': 'EM', 'LastName': 'Schrooten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Wouda', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Menno Pj', 'Initials': 'MP', 'LastName': 'de Winther', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Medical Biochemistry, Section of Experimental Vascular Biology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aten', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Pathology, Amsterdam, Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Van den Bossche', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Molecular Cell Biology and Immunology, Amsterdam Cardiovascular Sciences, Cancer Center Amsterdam, Amsterdam, Netherlands.'}]",JCI insight,['10.1172/jci.insight.130508'] 810,31672941,Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion.,"BACKGROUNDInsulin resistance results from impaired skeletal muscle glucose transport/phosphorylation, linked to augmented lipid availability. Despite greater intramuscular lipids, athletes are highly insulin sensitive, which could result from higher rates of insulin-stimulated glycogen synthesis or glucose transport/phosphorylation and oxidation. Thus, we examined the time course of muscle glycogen and glucose-6-phosphate concentrations during low and high systemic lipid availability.METHODSEight endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline in a randomized crossover design. Glycogen and glucose-6-phosphate concentrations were monitored in vastus lateralis muscles using 13C/31P magnetic resonance spectroscopy.RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants. During Intralipid infusion, insulin sensitivity remained higher in the athletes (ΔRd: 25 ± 3 vs. 17 ± 3 μmol/kg/min, P < 0.05), supported by higher glucose transporter type 4 protein expression than in sedentary humans. Compared to saline infusion, AUC of glucose-6-phosphate remained unchanged during Intralipid infusion in athletes (1.6 ± 0.2 mmol/L vs. 1.4 ± 0.2 [mmol/L] × h, P = n.s.) but tended to decrease by 36% in sedentary humans (1.7 ± 0.4 vs. 1.1 ± 0.1 [mmol/L] × h, P < 0.059). This drop was accompanied by a 72% higher rate of net glycogen synthesis in the athletes upon Intralipid infusion (47 ± 9 vs. 13 ± 3 μmol/kg/min, P < 0.05).CONCLUSIONAthletes feature higher skeletal muscle glucose disposal and glycogen synthesis during increased lipid availability, which primarily results from maintained insulin-stimulated glucose transport with increased myocellular glucose-6-phosphate levels for subsequent glycogen synthesis.TRIAL REGISTRATIONClinicalTrials.gov NCT01229059.FUNDINGGerman Federal Ministry of Health (BMG).",2019,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,[],"['endurance-trained and 9 sedentary humans (VO2 peak: 56 ± 2 vs. 33 ± 2 mL/kg/min, P < 0.05) underwent 6-hour hyperinsulinemic-isoglycemic clamp tests with infusions of triglycerides or saline']","['Glycogen and glucose-6-phosphate concentrations', 'insulin sensitivity', 'time course of muscle glycogen and glucose-6-phosphate concentrations', 'AUC of glucose-6-phosphate', 'insulin-stimulated glucose disposal rate (Rd', 'net glycogen synthesis', 'muscle glucose transport and glycogen synthesis']",[],"[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0672761', 'cui_str': 'glycerol-6-phosphate transporter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}]",,0.0359948,RESULTSAthletes displayed a 25% greater (P < 0.05) insulin-stimulated glucose disposal rate (Rd) than sedentary participants.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Begovatz', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bierwagen', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.127928'] 811,31977303,A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study.,"INTRODUCTION We aimed to investigate the safety and preliminary efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent urethral stricture. METHODS Men with bulbar urethral strictures ≤2 cm with 1-4 prior endoscopic treatments were enrolled at four study sites after ethics committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2-5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months. RESULTS A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54-82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence. CONCLUSIONS One-year data indicates the Optilume paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.",2020,Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54-82%) at 12 months.,"['Men with bulbar urethral strictures ≤2 cm with 1-4 prior endoscopic treatments were enrolled at four study sites after Ethics Committee approvals', 'recurrent urethral stricture', 'urethral stricture disease', 'A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup', 'recurrent bulbar urethral strictures']","['paclitaxel-coated balloon', 'Optilume ™ paclitaxel-coated balloon', 'mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment']","['symptom recurrence', 'serious adverse events', 'cystoscopic recurrences', 'Anatomic success', 'serious complications through 90 days post-procedure']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4524105', 'cui_str': 'Symptom recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",53.0,0.0267478,Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54-82%) at 12 months.,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Virasoro', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'DeLong', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Mann', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Rafael E', 'Initials': 'RE', 'LastName': 'Estrella', 'Affiliation': 'Clinica Union Medica, Santiago de los Caballeros, Dominican Republic.'}, {'ForeName': 'Merycarla', 'Initials': 'M', 'LastName': 'Pichardo', 'Affiliation': 'URUS, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Ramon Rodriguez', 'Initials': 'RR', 'LastName': 'Lay', 'Affiliation': 'Cirujano Urology Royal Center Panama City, Panama.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Espino', 'Affiliation': 'Centro Especializado San Fernando, Panama City, Panama.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Roth', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Elliott', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, MN, United States.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6323'] 812,31958480,Measuring attentional bias to food cues in young children using a visual search task: An eye-tracking study.,"OBJECTIVE Attentional bias to food cues may be a risk factor for childhood obesity, yet there are few paradigms to measure such biases in young children. Therefore, the present work introduces an eye-tracking visual search task to measure attentional bias in young children. METHODS Fifty-one 3-6-year-olds played a game to find a target cartoon character among food (experimental condition) or toy (control condition) distractors. Children completed the experimental and toy conditions on two separate visits in randomized order. Behavioral (response latencies) and eye-tracking measures (time to first fixation, initial gaze duration duration, cumulative gaze duration ) of attention to food and toy cues were computed. Regressions were used to test for attentional bias to food versus toy cues, and whether attentional bias to food cues was related to current BMI z-score. RESULTS Children spent more cumulative time looking at food versus toy distractors and took longer to locate the target when searching through food versus toy distractors. The faster children fixated on their first food versus toy distractor was associated with higher BMI z-scores. CONCLUSIONS Using a game-based paradigm employing eye-tracking, we found a behavioral attentional bias to food vs. toy distractors in young children. Further, attentional bias to food cues was associated with current BMI z-score.",2020,"RESULTS Children spent more cumulative time looking at food versus toy distractors and took longer to locate the target when searching through food versus toy distractors.","['Fifty-one 3-6-year-olds played a', 'young children']",['game to find a target cartoon character among food (experimental condition) or toy (control condition) distractors'],"['Measuring attentional bias to food cues', 'cumulative time looking', 'BMI z-scores', 'Behavioral (response latencies) and eye-tracking measures (time to first fixation, initial gaze duration duration, cumulative gaze duration ) of attention to food and toy cues']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0040565', 'cui_str': 'Toys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040565', 'cui_str': 'Toys'}]",,0.0224604,"RESULTS Children spent more cumulative time looking at food versus toy distractors and took longer to locate the target when searching through food versus toy distractors.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brand', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA. Electronic address: John.brand@dartmouth.edu.'}, {'ForeName': 'Travis D', 'Initials': 'TD', 'LastName': 'Masterson', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Emond', 'Affiliation': 'Department of Biomedical Data Science, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Lansigan', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gilbert-Diamond', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}]",Appetite,['10.1016/j.appet.2020.104610'] 813,31583748,Cognitively-Based Compassion Training for parents reduces cortisol in infants and young children.,"This study tests a group-based secular contemplative practice intervention, Cognitively-Based Compassion Training (CBCT), with parents of young children. We report on a randomized controlled preliminary efficacy study. Certified teachers administered CBCT for 20 hr across 8 to 10 weeks in two cohorts of parents with infants and young children. The intervention group was compared to a waitlist control group. Thirty-nine parents and their children, who ranged in age from 4 months to 5 years, were evaluated at pre- and postintervention (n = 25 intervention, n = 14 waitlist control) on hair cortisol concentration. Parents also completed self-administered questionnaires at both time points regarding demographics, physical symptoms of stress, parenting stress, self-compassion, and mindfulness. Children of parents in the CBCT group experienced significant decreases in cortisol at the postintervention assessment, as compared with the control group. However, parent cortisol and self-report measures did not significantly change other than a small effect on clinical levels of parenting stress. CBCT may be a positive new way to intervene with parents to lower infants' and young children's cumulative physiological stress.",2020,"Children of parents in the CBCT group experienced significant decreases in cortisol at the postintervention assessment, as compared with the control group.","['parents of young children', 'infants and young children', 'Thirty-nine parents and their children, who ranged in age from 4 months to 5 years, were evaluated at pre- and postintervention (n = 25 intervention, n = 14 waitlist control) on hair cortisol concentration']","['group-based secular contemplative practice intervention, Cognitively-Based Compassion Training (CBCT', 'CBCT', 'Cognitively-Based Compassion Training', 'waitlist control group']","['demographics, physical symptoms of stress, parenting stress, self-compassion, and mindfulness', 'clinical levels of parenting stress', 'cortisol']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",39.0,0.0196514,"Children of parents in the CBCT group experienced significant decreases in cortisol at the postintervention assessment, as compared with the control group.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Poehlmann-Tynan', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Engbretson', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Abra B', 'Initials': 'AB', 'LastName': 'Vigna', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Lindsay A', 'Initials': 'LA', 'LastName': 'Weymouth', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Burnson', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Zahn-Waxler', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Emily D', 'Initials': 'ED', 'LastName': 'Gerstein', 'Affiliation': 'University of Missouri, St. Louis, Missouri.'}, {'ForeName': 'Kerrie A', 'Initials': 'KA', 'LastName': 'Fanning', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Raison', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}]",Infant mental health journal,['10.1002/imhj.21831'] 814,31188734,Cardiovascular Morbidity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Patients with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.,"PURPOSE Androgen deprivation therapy may increase the risk of cardiovascular disease. Limited data suggest that GnRH (gonadotropin-releasing hormone) antagonist may be associated with a lower risk of cardiovascular disease than GnRH agonist. MATERIALS AND METHODS We performed a phase II, randomized, open label study in men with prostate cancer and preexisting cardiovascular disease who were randomized to receive GnRH agonists or antagonists for 1 year. The primary outcome was endothelial function measured by the EndoPAT 2000 device (Itamar Medical, Caesarea, Israel). The predefined secondary outcome was a new cardiovascular event. Patients were followed for the development of cardiovascular disease, defined as death, myocardial infarction, a cerebrovascular event, percutaneous angioplasty with coronary stent insertion or hospitalizations due to cardiac events. RESULTS A total of 80 patients were enrolled in study, including 41 and 39 who received GnRH antagonist and agonist, respectively. Patients in each arm had similar baseline characteristics. We did not detect a difference in the primary end point (endothelial function) between the groups (mean ± SD reactive hyperemia index 2.07 ± 0.15 vs 1.92 ± 0.11, p=0.42). However, during the trial period a new cardiovascular event (the secondary end point) developed in 15 patients. Of cases new major cardiovascular and cerebrovascular events developed in 9, including death in 2, myocardial infarction in 1, a cerebrovascular event in 2 and percutaneous angioplasty with coronary stent insertion in 4. Of the patients 20% randomized to GnRH agonist experienced a major cardiovascular and cerebrovascular event compared to 3% of those on GnRH antagonist (p=0.013). The absolute risk reduction in major cardiovascular and cerebrovascular events at 12 months using GnRH antagonist was 18.1% (95% CI 4.6-31.2, p=0.032). CONCLUSIONS To our knowledge this is the first prospective study to test cardiovascular outcomes among patients with prostate cancer who received androgen deprivation therapy. No differences in the primary end point were noted between the study arms. However, the secondary end point revealed that patients treated with GnRH agonist experienced significantly more major cardiovascular and cerebrovascular events than those treated with GnRH antagonist. These phase II results suggest that in patients with prostate cancer who have preexisting cardiovascular disease selecting the androgen deprivation therapy modality may differentially affect cardiac outcomes.",2019,Twenty percent of patients randomized to GnRH-agonist had a MACCE compared to 3% antagonists (p=0.013).,"['patients with advanced prostate-cancer and pre-existing cardiovascular disease', 'Eighty patients were enrolled (41 GnRH-antagonist, 39 GnRH-agonist', 'men with prostate-cancer and pre-existing CVD randomized to receive', 'prostate-cancer patients receiving ADT']","['GnRH-agonists or antagonists for one year', 'MACCE', 'GnRH-agonist and GnRH-antagonist', 'Androgen-deprivation therapy (ADT']","['new incident of cardiovascular-event', 'endothelial function', 'cardiovascular-disease (CVD', 'absolute risk reduction for MACCE', 'death, myocardial infarction (MI), cerebrovascular-event (CVA), or percutaneous-angioplasty with coronary stent-insertion (PCA) or hospitalizations due to cardiac-events', 'endothelial-function', 'Cardiovascular morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0411287', 'cui_str': 'Percutaneous transluminal balloon angioplasty (procedure)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}]",80.0,0.127051,Twenty percent of patients randomized to GnRH-agonist had a MACCE compared to 3% antagonists (p=0.013).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Peer', 'Affiliation': 'Department of Oncology, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shavit-Grievink', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Tzlil', 'Initials': 'T', 'LastName': 'Tabachnik', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Sela', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Witberg', 'Affiliation': 'Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Wilhelmina C M', 'Initials': 'WCM', 'LastName': 'Duivenvoorden', 'Affiliation': 'Division of Urology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Rosenbaum', 'Affiliation': 'Davidoff Cancer Centre, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Jehonathan H', 'Initials': 'JH', 'LastName': 'Pinthus', 'Affiliation': 'Division of Urology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000000384'] 815,31755131,Restrictive allograft dysfunction after lung transplantation: is there a place for nintedanib?-a case report.,"One of the posttransplantation complications is represented by chronic lung allograft dysfunction, which has two main clinical presentations: bronchiolitis obliterans syndrome and restrictive allograft syndrome. The latter being challenging because of poor prognosis and only symptomatic treatment, and characterized by fibrotic process. A 63-year-old man was right lung-transplanted in 2009 due to idiopathic pulmonary fibrosis. In 2011, bronchiolitis obliterans syndrome was diagnosed evolving to restrictive allograft syndrome in 2016. An off-label treatment by nintedanib (150 mg twice a day) was introduced. Unfortunately, it was stopped 4 months later because of digestive intolerance, without any clinical improvement. Contrary to a previous case reported, our patient did not have any benefit of nintedanib. Antifibrotic agents' effects such as nintedanib on restrictive allograft syndrome should be assessed in further randomized double-blind placebo-controlled studies.",2020,"Unfortunately, it was stopped four months later because of digestive intolerance, without any clinical improvement.","['A 63-year-old man was right lung transplanted in 2009 due to idiopathic pulmonary fibrosis', 'Restrictive allograft dysfunction after lung transplantation']",['placebo'],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0225706', 'cui_str': 'Right lung structure'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0507581,"Unfortunately, it was stopped four months later because of digestive intolerance, without any clinical improvement.","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pluchart', 'Affiliation': 'Pôle pharmacie, Centre Hospitalier Universitaire Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Chanoine', 'Affiliation': 'Pôle pharmacie, Centre Hospitalier Universitaire Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Briault', 'Affiliation': 'Service Hospitalier Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, Centre Hospitalier Universitaire Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Claustre', 'Affiliation': 'Université Grenoble Alpes, F-38000, Grenoble, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Bedouch', 'Affiliation': 'Pôle pharmacie, Centre Hospitalier Universitaire Grenoble Alpes, F-38000, Grenoble, France.'}]",Fundamental & clinical pharmacology,['10.1111/fcp.12522'] 816,31960954,Drug therapy for delirium in terminally ill adults.,"BACKGROUND Delirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary. This is the second update of the review first published in 2004. OBJECTIVES To evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries. SELECTION CRITERIA We included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older). DATA COLLECTION AND ANALYSIS We independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables. MAIN RESULTS We included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events. 1. Haloperidol versus placebo There may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) -0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium). Haloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD -0.14, 95% -0.28 to -0.00; 123 participants with mild- to moderate-severity delirium). Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium). 2. Haloperidol versus risperidone There may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD -0.42, 95% CI -0.90 to 0.06; 126 participants) or 48 hours (MD -0.36, 95% CI -0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison. 3. Haloperidol versus olanzapine We are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI -0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI -1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison. 4. Risperidone versus placebo Risperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium). There may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD -0.05, 95% CI -0.19 to 0.09; 111 participants with mild- to moderate-severity delirium). Risperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium). 5. Lorazepam plus haloperidol versus placebo plus haloperidol We are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI -1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI -0.19 to 2.63; 31 participants with moderate to severe delirium). 6. Haloperidol versus chlorpromazine We are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI -4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI -4.22 to 5.14; 24 participants). 7. Haloperidol versus lorazepam We are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD -4.88, 95% CI -9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD -6.66, 95% CI -14.85 to 1.53; 17 participants). 8. Lorazepam versus chlorpromazine We are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported. SECONDARY OUTCOMES use of rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE. AUTHORS' CONCLUSIONS We found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.",2020,"Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).","['terminally ill adults', 'participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium', '123 participants with mild- to moderate-severity delirium', '399 participants', 'terminally ill adults (18 years or older', 'delirium in terminally ill adults', 'people with mild- to moderate-severity delirium']","['olanzapine', 'haloperidol', 'lorazepam plus haloperidol', 'Haloperidol', 'placebo, standard care or wait-list control', 'lorazepam', 'placebo plus haloperidol', 'risperidone', 'placebo Risperidone', 'placebo', 'chlorpromazine', 'Risperidone', 'Lorazepam', 'haloperidol and risperidone', 'Lorazepam plus haloperidol']","['Agitation scores and adverse events', 'Agitation scores', 'use of rescue medication; cognitive status; survival', 'extrapyramidal adverse events', 'reduces agitation', 'effectiveness and safety', 'rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE', 'extrapyramidal adverse effects', 'adverse events', 'delirium symptoms; agitation score; adverse events', 'delirium symptoms', 'agitation']","[{'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",123.0,0.609966,"Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Finucane', 'Affiliation': 'Marie Curie Hospice Edinburgh, 45 Frogston Road West, Edinburgh, UK, EH10 7DR.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Medical Statistics, London, UK.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stone', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tookman', 'Affiliation': 'Marie Curie Hospice, 11 Lyndhurst Gardens, Hamstead, London, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Candy', 'Affiliation': 'University College London, Marie Curie Palliative Care Research Department, Division of Psychiatry, London, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004770.pub3'] 817,31022593,Does prolonged exposure increase suicide risk? Results from an active duty military sample.,"The efficacy of prolonged exposure (PE) on suicide ideation (SI) as a secondary outcome among individuals with posttraumatic stress disorder (PTSD) is unclear. The purpose of this study was to compare the efficacy of PE in two formats (spaced, S-PE, 10 sessions over 8 weeks, and massed, M-PE, 10 sessions over 2 weeks) to Present Centered Therapy (PCT) and minimal contact control (MCC) on SI exacerbation among patients without suicide intent or plans. Active duty military personnel (n = 335) were randomized to: (1) S-PE vs. PCT and (2) M-PE vs. MCC. All participants completed the Beck Scale for Suicide Ideation and the Beck Depression Inventory (Suicide item) at baseline, posttreatment, and follow-ups. S-PE and PCT had significant and comparable reductions in SI during treatment. M-PE had significantly steeper reductions in SI during treatment compared to MCC. Specifically, more participants in M-PE compared to MCC had reliable improvement versus reliable exacerbation. Reduction in PTSD symptoms was significantly associated with reduction of SI. PE was associated with significant reductions in SI over time that were comparable to PCT and superior to MCC. These findings suggest that both trauma- and non-trauma-focused treatments are associated with reductions in SI, and that trauma-focused treatments improve SI relative to waitlist.",2019,M-PE had significantly steeper reductions in SI during treatment compared to MCC.,"['Active duty military personnel (n\u202f=\u202f335', 'individuals with posttraumatic stress disorder (PTSD', 'patients without suicide intent or plans']","['S-PE vs. PCT and (2) M-PE vs. MCC', 'Centered Therapy (PCT) and minimal contact control (MCC', 'PE', 'prolonged exposure (PE', 'MCC']","['SI', 'Beck Scale for Suicide Ideation and the Beck Depression Inventory (Suicide item', 'PTSD symptoms', 'suicide ideation (SI']","[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}]",335.0,0.0922884,M-PE had significantly steeper reductions in SI during treatment compared to MCC.,"[{'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA. Electronic address: lilybr@upenn.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA; (b)National Center for PTSD, VA Palo Alto Health Care System, 795 Willow Rd., Menlo Park, CA, USA.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zandberg', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Headquarters, Carl R. Darnall Army Medical Center, 36065 Santa Fe Avenue, Fort Hood, TX, USA.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research Center, VA Boston Health Care System, 150 S Huntington Ave, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, 720 Harrison Ave., Boston, MA, USA; Department of Psychological and Brain Sciences, Boston University, 64 Cummington Mall, Boston, MA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX, USA; Department of Psychology, University of Texas at San Antonio, One UTSA Circle, San Antonio, TX, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, 332 S 1400 E, Building 73, Salt Lake City, UT, USA; Department of Psychology, The University of Utah, 1721 Campus Center Drive Saec, 3220 S, Salt Lake City, UT, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, 8300 Floyd Curl Dr., San Antonio, TX, USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market St., Suite 600 North, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Behaviour research and therapy,['10.1016/j.brat.2019.04.003'] 818,31959340,"Preoperative cisplatin, fluorouracil, and docetaxel with or without radiotherapy after poor early response to cisplatin and fluorouracil for resectable oesophageal adenocarcinoma (AGITG DOCTOR): results from a multicentre, randomised controlled phase II trial.","BACKGROUND Patients with oesophageal/gastro-oesophageal junction adenocarcinoma (EAC) not showing early metabolic response (EMR) to chemotherapy have poorer survival and histological response rates <5%. We investigated whether tailoring neoadjuvant therapy can improve outcomes in these patients. PATIENTS AND METHODS Patients with resectable EAC were enrolled and randomised into two single-arm, multicentre phase II trials. After induction cisplatin and 5-fluorouracil (CF), all were assessed by day 15 positron emission tomography (PET). Patients with an EMR [maximum standardised uptake values (SUVmax) ≥35% reduction from baseline to day 15 PET] received a second CF cycle then oesophagectomy. Non-responders were randomised 1 : 1 to two cycles of CF and docetaxel (DCF, n = 31) or DCF + 45 Gy radiotherapy (DCFRT, n = 35) then oesophagectomy. The primary end point was major histological response (<10% residual tumour) in the oesophagectomy specimen; secondary end points were overall survival (OS), progression-free survival (PFS), and locoregional recurrence (LR). RESULTS Of 124 patients recruited, major histological response was achieved in 3/45 (7%) with EMR, 6/30 (20%) DCF, and 22/35 (63%) DCFRT patients. Grade 3/4 toxicities occurred in 12/45 (27%) EMR (CF), 13/31 (42%) DCF, and 25/35 (71%) DCFRT patients. No treatment-related deaths occurred. LR by 3 years was seen in 5/45 (11%) EMR, 10/31 (32%) DCF, and 4/35 (11%) DCFRT patients. PFS [95% confidence interval (CI)] at 36 months was 47% (31% to 61%) for EMR, 29% (15% to 45%) for DCF, and 46% (29% to 61%) for DCFRT patients. OS (95% CI) at 60 months was 53% (37% to 67%) for EMR, 31% (16% to 48%) for DCF, and 46% (29% to 61%) for DCFRT patients. CONCLUSIONS EMR is associated with favourable OS, PFS, and low LR. For non-responders, the addition of docetaxel augmented histological response rates, but OS, PFS, and LR remained inferior compared with responders. DCFRT improved histological response and PFS/LR outcomes, matching the EMR group. Early PET/CT has the potential to tailor therapy for patients not showing an early response to chemotherapy. TRIAL REGISTRATION ACTRN12609000665235.",2020,"For non-responders, the addition of docetaxel augmented histological response rates, but OS, PFS, and LR remained inferior compared with responders.","['DCFRT patients', 'resectable oesophageal adenocarcinoma (AGITG DOCTOR', 'Patients with oesophageal/gastro-oesophageal junction adenocarcinoma (EAC', 'Patients with resectable EAC', 'Patients with an EMR']","['cisplatin and fluorouracil', 'Preoperative cisplatin, fluorouracil, and docetaxel with or without radiotherapy', 'EMR', 'induction cisplatin and 5-fluorouracil (CF', 'CF and docetaxel (DCF, n\xa0= 31) or DCF\xa0+ 45 Gy radiotherapy (DCFRT, n\xa0= 35) then oesophagectomy', 'docetaxel', 'DCFRT']","['overall survival (OS), progression-free survival (PFS), and locoregional recurrence (LR', 'PFS', 'histological response and PFS/LR outcomes', 'survival and histological response rates', 'histological response rates', 'Grade 3/4 toxicities', 'major histological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma Of Esophagus'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",124.0,0.25518,"For non-responders, the addition of docetaxel augmented histological response rates, but OS, PFS, and LR remained inferior compared with responders.","[{'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Barbour', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia; Faculty of Medicine, The University of Queensland, Brisbane, Australia. Electronic address: a.barbour@uq.edu.au.'}, {'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Walpole', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Mai', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Barnes', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Department of Surgery, Flinders Medical Centre, Adelaide, Australia; School of Medicine, Flinders University, Adelaide, Australia.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Ackland', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': ""Faculty of Medicine, The University of Queensland, Brisbane, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Finch', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Department of Surgery, Flinders Medical Centre, Adelaide, Australia; School of Medicine, Flinders University, Adelaide, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shannon', 'Affiliation': 'Nepean Cancer Centre, Nepean Hospital, Sydney, Australia.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Nott', 'Affiliation': 'Medical Oncology, Royal Hobart Hospital, Hobart, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Varma', 'Affiliation': 'Cancer Services, Townsville Hospital, Townsville, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Clinical Trials Unit, Sydney Adventist Hospital, Sydney, Australia.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Falk', 'Affiliation': 'Clinical Trials Unit, Sydney Adventist Hospital, Sydney, Australia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oostendorp', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia; Clinical Trials, Mater Research Institute, Brisbane, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lampe', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simes', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Smithers', 'Affiliation': 'Divisions of Surgery and Cancer Services, Princess Alexandra Hospital, Brisbane, Australia; Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.019'] 819,31958540,Routine Interportal Capsular Repair Does Not Lead to Superior Clinical Outcome Following Arthroscopic Femoroacetabular Impingement Correction With Labral Repair.,"PURPOSE To evaluate the impact of routine capsular repair on clinical outcome in a consecutive series of patients undergoing arthroscopic correction of symptomatic femoroacetabular impingement. METHODS Between 2009 and 2015, patients were assigned to 1 of 2 groups based on whether a capsular repair was performed as part of their index hip arthroscopic procedure. Exclusion criteria included previous underlying hip conditions, Tönnis >1, age >45 years, and labrum not repaired. Patients were assessed preoperatively and 2-years postoperatively using patient-reported outcome measures (PROMs), including the modified Harris hip score (mHHS), UCLA activity scale, short form-36, Western Ontario and McMaster Universities Osteoarthritis Index score, and measures of range of hip movements. The incidence of any subsequent revision surgery within 2 years was recorded. Sex and age groups were specifically analyzed. RESULTS In total, 966 consecutive cases were included (96.4% follow-up rate): 508 in group A (no repair) and 458 in group B (repair). Average age for all cases was 28.1 ± 7.0 years (14.6-44.9). There were significant improvements in all PROMs following surgery for both groups (P < .001). Statistical significance between groups at 2 years was observed for Short Form-36 (P = .001) and WOMAC (P = .041), greater in group A. Both groups similarly met the minimal clinically important difference (mHHS P = .414 and .605; UCLA, P = .549 and .614; Short Form-36, P = .455 and .079; WOMAC, P = .425 and .750 for distribution and anchor-based methods, respectively). In total, 38 (7.8%) cases group A and 24 (5.4%) cases group B required repeat hip arthroscopy (HA) (P = .148); No (0%) cases in group A and 2 (0.45%) cases in group B required total hip replacement (P = .226). There was significantly lower rate of repeat HA among 25- to 34-year age group (8.6% vs 3.9%, P = .047) where capsular repair was performed. No significant difference in the rate of repeat HA between groups for male (P = .203) or female (P = .603) subjects. Adhesions were more common in the repair group (79.2%, 95% confidence interval [CI] 57.8-92.9 vs 55.3%, CI 38.3-71.4; P = .055), with further capsular repair/plication required more frequently in the unrepaired group (50%, CI 33.4-66.6 vs 25%, CI 10.8-44.3); however, differences between groups were not significant (P = .051). Internal rotation was larger in group A compared with group B at 2 years (36.2 vs 28.1, P = .000). Female patients with capsular repair had reduced PROM scores at 2 years compared with female patients without repair (WOMAC, P = .004, and mHHS, P = .037). CONCLUSIONS Arthroscopic correction of femoroacetabular impingement with labral repair results in significant improvements in patient-reported outcomes at 2-years postsurgery, irrespective of whether the capsule is repaired. Routine capsular repair in a consecutive series of patients did not lead to superior outcomes compared with a nonrepaired group; similar proportions of cases in both groups were able to achieve minimal clinically important difference. In female patients, routinely repairing the capsule may lead to statistically inferior clinical outcome at 2-years postsurgery, although this may not be clinically significant. Routine capsular repair, however, may be beneficial in the younger, active patient, where a significant reduction in repeat arthroscopy was observed. LEVEL OF EVIDENCE Level III, retrospective comparative study.",2020,Routine capsular repair in a consecutive series of patients did not lead to superior outcomes compared to a non-repaired group; Similar proportions of cases in both groups were able to achieve MCID.,"['patients undergoing arthroscopic correction of symptomatic femoro-acetabular impingement (FAI) METHODS', 'Exclusion criteria included prior underlying hip conditions, Tonnis >1, age >45 years, labrum not repaired', '966 consecutive cases were included (96.4% follow-up rate): 508 Group A(No Repair), 458 Group B(Repair', 'Female patients with capsular repair']","['routine capsular repair', 'Arthroscopic FAI Correction With Labral Repair']","['Internal rotation', 'Adhesions', 'PROM scores', 'modified Harris hip score (mHHS), UCLA activity scale, short form-36, WOMAC osteoarthritis index, and measures of range of hip movements', 'rate of repeat HA', 'repeat hip arthroscopy (HA', 'incidence of any subsequent revision surgery', 'total hip replacement', 'capsular repair/plication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1277206', 'cui_str': 'Subsequent revision'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]",966.0,0.0930817,Routine capsular repair in a consecutive series of patients did not lead to superior outcomes compared to a non-repaired group; Similar proportions of cases in both groups were able to achieve MCID.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Filan', 'Affiliation': 'Hip and Groin Clinic, UPMC Whitfield, Butlerstown North, Waterford, Co. Waterford, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Carton', 'Affiliation': 'Hip and Groin Clinic, UPMC Whitfield, Butlerstown North, Waterford, Co. Waterford, Ireland. Electronic address: cartoni2k@hotmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.12.002'] 820,31791663,Intravitreal Combined Aflibercept + Anti-Platelet-Derived Growth Factor Receptor β for Neovascular Age-Related Macular Degeneration: Results of the Phase 2 CAPELLA Trial.,"PURPOSE To compare the efficacy and safety of intravitreal aflibercept + anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). DESIGN Phase 2, randomized, double-masked study. PARTICIPANTS A total of 505 patients (eyes) with nAMD. METHODS Patients were randomized 1:2:2 to low-dose combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone every 4 weeks through week 12. At week 12, patients in the HD combo and IAI groups were re-randomized to continue as assigned or switch to HD combo → IAI or IAI → HD combo and dosed every 4 weeks through week 28. During weeks 28 to 52, patients received treatment as needed per prespecified criteria. This report presents efficacy through week 28 and safety through week 52. MAIN OUTCOME MEASURES Mean best-corrected visual acuity (BCVA) change from baseline at week 12 (primary end point). RESULTS At week 12, mean BCVA gains from baseline were 5.8, 5.8, and 7.5 letters with LD combo, HD combo, and IAI, respectively (P = 0.21 for LD combo and P = 0.10 for HD combo vs. IAI). The corresponding proportions of eyes that gained ≥15 letters were 12%, 19%, and 22%, respectively. Mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. Proportions of eyes with complete resolution of fluid from baseline were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with the week 12 results. Through week 52, the incidence of intraocular inflammation was 1.0%, 7.5%, 2.1%, 2.1%, and 0%, respectively. The incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events was 1.9%, 0.9%, 1.1%, 2.1%, and 1.9%, respectively. CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone. Anatomic outcomes evaluating complete fluid resolution favored IAI. Adverse events were consistent with the reported IAI safety profile, except for a higher frequency of intraocular inflammation in the HD combo group.",2020,"CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","['Patients', 'A total of 505 patients (eyes) with nAMD', 'Neovascular Age-Related Macular Degeneration', 'patients with treatment-naïve neovascular age-related macular degeneration (nAMD']","['Intravitreal Combined Aflibercept\xa0+ Anti-Platelet-Derived Growth Factor Receptor β', 'intravitreal aflibercept\xa0+ anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy', 'combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone']","['Mean reductions in central retinal thickness', 'intraocular inflammation', 'Mean best-corrected visual acuity (BCVA) change', ""incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events"", 'efficacy and safety', 'Adverse events', 'mean BCVA gains', 'incidence of intraocular inflammation', 'BCVA', 'Vision and anatomic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0071253', 'cui_str': 'Platelet-Derived Growth Factor Receptor'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",505.0,0.165178,"CONCLUSIONS Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone.","[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kitchens', 'Affiliation': 'Retina Associates of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'Retina Research Institute of Texas, Abilene, Texas.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Lorah', 'Initials': 'L', 'LastName': 'Perlee', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Chu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leal', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Asmus', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': 'Bayer Healthcare, Berlin, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas. Electronic address: dmbmd@houstonretina.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.021'] 821,31474439,Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial.,"PURPOSE Geographic atrophy (GA), a late stage of age-related macular degeneration (AMD), is a major cause of blindness. Even while central visual acuity remains relatively well preserved, GA often causes considerable compromise of visual function and quality of life. No treatment currently exists. We evaluated the safety and efficacy of pegcetacoplan, a complement C3 inhibitor, for treatment of GA. DESIGN Prospective, multicenter, randomized, sham-controlled phase 2 study. PARTICIPANTS Two hundred forty-six patients with GA. METHODS Patients with GA were assigned randomly in a 2:2:1:1 ratio to receive intravitreal injections of 15 mg pegcetacoplan monthly or every other month (EOM) or sham intravitreal injections monthly or EOM for 12 months with follow-up at months 15 and 18. Area and growth of GA were measured using fundus autofluorescence imaging. MAIN OUTCOME MEASURES The primary efficacy end point was mean change in square root GA lesion area from baseline to month 12. Secondary outcome measures included mean change from baseline in GA lesion area without the square root transformation, distance of GA lesion from the fovea, best-corrected visual acuity (BCVA), low-luminance BCVA, and low-luminance visual acuity deficit. The primary safety end point was the number and severity of treatment-emergent adverse events. RESULTS In patients receiving pegcetacoplan monthly or EOM, the GA growth rate was reduced by 29% (95% confidence interval [CI], 9-49; P = 0.008) and 20% (95% CI, 0-40; P = 0.067) compared with the sham treatment group. Post hoc analysis showed that the effect was greater in the second 6 months of treatment, with observed reductions of 45% (P = 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively. Two cases of culture-positive endophthalmitis and 1 case of culture-negative endophthalmitis occurred in the pegcetacoplan monthly group. New-onset investigator-determined exudative AMD was reported more frequently in pegcetacoplan-treated eyes (18/86 eyes [20.9%] and 7/79 eyes [8.9%] in monthly and EOM groups, respectively) than in sham-treated eyes (1/81 eyes [1.2%]). CONCLUSIONS Local C3 inhibition with pegcetacoplan resulted in statistically significant reductions in the growth of GA compared with sham treatment. Phase 3 studies will define the efficacy and safety profile further.",2020,"= 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively.","['Geographic Atrophy Secondary to Age-Related Macular Degeneration', 'Patients with GA', 'Two hundred forty-six patients with GA']","['Complement C3 Inhibitor Pegcetacoplan', 'pegcetacoplan', 'intravitreal injections of 15 mg pegcetacoplan monthly or every other month (EOM) or sham intravitreal injections monthly or EOM']","['mean change in square root GA lesion area', 'GA growth rate', 'visual function and quality of life', 'culture-negative endophthalmitis', 'mean change from baseline in GA lesion area without the square root transformation, distance of GA lesion from the fovea, best-corrected visual acuity (BCVA), low-luminance BCVA, and low-luminance visual acuity deficit', 'growth of GA', 'New-onset investigator-determined exudative AMD', 'number and severity of treatment-emergent adverse events', 'Area and growth of GA', 'safety and efficacy']","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0009506', 'cui_str': 'Complement C3'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034380'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C0014236', 'cui_str': 'Ophthalmia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0234684', 'cui_str': 'Luminance, function (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",246.0,0.241444,"= 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liao', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Beverly Hills, California. Electronic address: dave_liao@laretina.com.'}, {'ForeName': 'Federico V', 'Initials': 'FV', 'LastName': 'Grossi', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'El Mehdi', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Gerber', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Vitreoretinal Consultants, Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Singerman', 'Affiliation': 'Retina Associates of Cleveland, Cleveland, Ohio.'}, {'ForeName': 'Prema', 'Initials': 'P', 'LastName': 'Abraham', 'Affiliation': 'Black Hills Regional Eye Institute, Rapid City, Iowa.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Grassmann', 'Affiliation': 'Institute of Human Genetics, University of Regensburg, Regensburg, Germany; Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nuernberg', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard H F', 'Initials': 'BHF', 'LastName': 'Weber', 'Affiliation': 'Institute of Human Genetics, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Deschatelets', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Robert Y', 'Initials': 'RY', 'LastName': 'Kim', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Carol Y', 'Initials': 'CY', 'LastName': 'Chung', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Ramiro M', 'Initials': 'RM', 'LastName': 'Ribeiro', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamdani', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retina-Vitreous Associates Medical Group, Los Angeles, California.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Slakter', 'Affiliation': 'Vitreous Retina Macula Consultants of New York, New York; New York University School of Medicine, New York, New York.'}, {'ForeName': 'Cedric G', 'Initials': 'CG', 'LastName': 'Francois', 'Affiliation': 'Apellis Pharmaceuticals, Inc, Waltham, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2019.07.011'] 822,31923471,"Memory advancement by intranasal insulin in type 2 diabetes (MemAID) randomized controlled clinical trial: Design, methods and rationale.","BACKGROUND Type 2 diabetes mellitus (T2DM) accelerates brain aging and increases the risk for dementia. Insulin is a key neurotrophic factor in the brain, where it modulates energy metabolism, neurovascular coupling, and regeneration. Impaired insulin-mediated brain signaling and central insulin resistance may contribute to cognitive and functional decline in T2DM. Intranasal insulin (INI) has emerged as a potential therapy for treating T2DM-related cognitive impairment. METHODS/DESIGN Ongoing from 2015, a prospective, two-center, randomized, double-blind, placebo-controlled trial of 210 subjects (120 T2DM and 90 non-diabetic older adults) randomized into four treatment arms (60 T2DM-INI, 60 T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo) evaluating the long-term effects of daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline) over 24 weeks and 24 weeks of post-treatment follow-up. Study outcomes are: 1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety. CONCLUSION This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia. Trial Registration NCT02415556.",2020,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","['type 2 diabetes (MemAID', 'older people with T2DM and non-diabetic controls', '210 subjects (120 T2DM and 90 non-diabetic older adults']","['daily intranasal administration of 40 International Units (IU) of human insulin, as compared to placebo (sterile saline', 'intranasal insulin', 'placebo', 'Memory advancement by intranasal insulin', 'T2DM-Placebo, 45 Control-INI, and 45 Control-Placebo', 'Intranasal insulin (INI']","['memory and cognition', '1) long-term INI effects on cognition, daily functionality, and gait speed; 2) identifying a clinically relevant phenotype that predicts response to INI therapy; 3) long-term safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0001560', 'cui_str': 'Drug Administration, Intranasal'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",210.0,0.477211,"This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Galindo-Mendez', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Trevino', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGlinchey', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fortier', 'Affiliation': 'Translational Research Center for TBI and Stress Disorders (TRACTS), Geriatric Research Education and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lioutas', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': ""Autonomic Laboratory, Department of Neurology, Brigham and Women's Faulkner Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA; Department of Medicine, Boston VA Healthcare System, Harvard Medical School, Boston, MA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Novak', 'Affiliation': 'Department of Neurology, SAFE Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Electronic address: vnovak@bidmc.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105934'] 823,31883426,Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation.,"Letermovir, a cytomegalovirus (CMV) terminase-complex inhibitor, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT). In a phase III, double-blind, randomized trial, letermovir significantly reduced the risk of clinically significant CMV infection (CS-CMVi) vs placebo through Week 24 post-HCT. This analysis investigated outcomes in participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis. In total, 70 of 565 randomized participants had detectable CMV DNA at randomization (letermovir 48; placebo 22). Study treatment completion rates were greater in letermovir-treated participants compared with placebo (52.1% vs 9.1%). The incidence of CS-CMVi or imputed primary endpoint events through Week 24 were 64.6% and 90.9% in the letermovir and placebo groups, respectively (treatment difference -26.1%; P = .010). Kaplan-Meier event rates for CS-CMVi onset through Week 14 (end-of-treatment period) were 33.1% for letermovir and 86.6% for placebo (P < .001). Median viral loads at the CS-CMVi events was similar in both treatment arms. All-cause mortality through Week 24 posttransplant was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (P = .268). Overall, clinical outcomes were similar to those reported for participants with undetectable CMV DNA at randomization.",2020,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","['participants with detectable CMV DNA at randomization, who were excluded from the primary efficacy analysis', 'adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (HCT', 'patients with detectable CMV DNA at randomization in the phase III trial of', 'allogeneic hematopoietic cell transplantation']","['placebo', 'letermovir']","['risk of clinically-significant CMV infection', 'incidence of CS-CMVi', 'Median viral loads', 'mortality rates']","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3852938', 'cui_str': 'letermovir'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",565.0,0.611867,"All-cause mortality through Week 24 post-transplantation was 15.0% for letermovir and 18.2% for placebo; through Week 48, mortality rates were 26.5% and 40.9%, respectively (p=0.268).","[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per T', 'Initials': 'PT', 'LastName': 'Ljungman', 'Affiliation': 'Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Chemaly', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Teal', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Butterton', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Wendy W', 'Initials': 'WW', 'LastName': 'Yeh', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Randi Y', 'Initials': 'RY', 'LastName': 'Leavitt', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Cyrus S', 'Initials': 'CS', 'LastName': 'Badshah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15764'] 824,31810456,A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients.,"BACKGROUND Paracetamol is recommended as first-line treatment for pain control in osteoarthritis because it has fewer side effects than do other therapeutic options, including nonsteroidal anti-inflammatory drugs (NSAIDs). Prescribing proton pump inhibitors (PPIs) as gastric bleeding prophylaxis in chronic NSAID users is also common, although not recommended. In Italy, paracetamol is not reimbursed by the National Health System. The aim of this trial was to test whether the availability to osteoarthritis patients of free paracetamol would decrease their use of NSAIDs and, as a secondary objective, whether opioid and PPI consumption would also decrease. METHODS Eight general practitioners (GPs) (59 patients) were randomized to usual care and 8 (58 patients) to the experimental arm, where prescribed paracetamol was directly distributed for free by the local hospital. After 6 months, paracetamol was also available for free in the control arm. The main outcome was the pre/post difference in average NSAID and PPI consumption. Differences between experimental and control arms in pre/post differences are reported, as registered by the drug prescription information system. RESULTS Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067). No changes were observed for PPIs (from 11.27 to 14.65 DDD and from 9.74 to 12.58 DDD in experimental and control arms, respectively, p = 0.788) or opioids (from 1.61 to 1.14 DDD and from 1.41 to 1.56 DDD in experimental and control arms, respectively, p = 0.419). When the intervention was extended to the control arm, no decrease in NSAID consumption was observed (from 2.46 to 2.43 DDD, p = 0.521). CONCLUSIONS Removing small economic barriers had small or no effect on the appropriateness of opioid or PPI prescribing to patients with osteoarthritis; a reduction in NSAID consumption cannot be ruled out. TRIAL REGISTRATION NUMBER NCT02691754 (Approved February 24, 2016).",2019,"RESULTS Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067).","['Eight general practitioners (GPs) (59 patients', 'chronic NSAID users', 'patients with osteoarthritis', 'Italy of distributing cost-free paracetamol to osteoarthritic patients']","['paracetamol', 'Prescribing proton pump inhibitors (PPIs', 'nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing']","['NSAID consumption', 'Average NSAID consumption', 'average NSAID and PPI consumption', 'PPIs']","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",8.0,0.0570507,"RESULTS Average NSAID consumption decreased non-significantly, from 6.79 to 2.16 defined daily dose (DDD) in the experimental arm and from 3.19 to 2.97 DDD in the control group (p = 0.067).","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Vicentini', 'Affiliation': 'Epidemiology Unit, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy , Reggio Emilia, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Mancuso', 'Affiliation': 'Epidemiology Unit, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy , Reggio Emilia, Italy. Pamela.Mancuso@ausl.re.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giorgi Rossi', 'Affiliation': 'Epidemiology Unit, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy , Reggio Emilia, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Di Pede', 'Affiliation': 'Pharmaceutical Department, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Pellati', 'Affiliation': 'Primary Health Care, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gandolfi', 'Affiliation': 'General Practitioner, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy, Reggio Emilia, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Zoboli', 'Affiliation': 'Pharmaceutical Department, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Riccò', 'Affiliation': 'Medical Directorate, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy, Reggio Emilia, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Busani', 'Affiliation': 'Pharmaceutical Department, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferretti', 'Affiliation': 'Pharmaceutical Department, Local Health Authority AUSL-IRCCS, Reggio Emilia, Italy.'}]",BMC family practice,['10.1186/s12875-019-1050-4'] 825,31959341,Bevacizumab as adjuvant treatment of colon cancer: updated results from the S-AVANT phase III study by the GERCOR Group.,"BACKGROUND The bevacizumab-Avastin® adjuVANT (AVANT) study did not meet its primary end point of improving disease-free survival (DFS) with the addition of bevacizumab to oxaliplatin-based chemotherapy in stage III colon cancer (CC). We report here the long-term survival results (S-AVANT). PATIENTS AND METHODS Patients with curatively resected stage III CC were randomly assigned to FOLFOX4, FOLFOX4-bevacizumab, or XELOX-bevacizumab. RESULTS A total of 2867 patients were randomized: FOLFOX4: n = 955, FOLFOX4-bevacizumab: n = 960, XELOX-bevacizumab: n = 952. With a median of 6.73 years follow-up (interquartile range 5.51-10.54), 672 patients died, of whom 198 (20.7%), 250 (26.0%), and 224 (23.5%) were in the FOLFOX4, FOLFOX4-bevacizumab, and XELOX-bevacizumab arms, respectively. The 10-year overall survival (OS) rates were 74.6%, 67.2%, and 69.9%, (P = 0.003) and 5-year disease-free survival (DFS) rates were 73.2%, 68.5%, and 71.0% (P = 0.174), respectively. OS and DFS hazard ratios were 1.29 [95% confidence interval (CI) 1.07-1.55; P = 0.008] and 1.16 (95% CI 0.99-1.37; P = 0.063) for FOLFOX4-bevacizumab versus FOLFOX4 and 1.15 (95% CI 0.95-1.39; P = 0.147) and 1.1 (95% CI 0.93-1.29; P = 0.269) for XELOX-bevacizumab versus FOLFOX4, respectively. CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively. Cardiovascular-related and sudden deaths during treatment or follow-up were reported in 13 (6.6%), 17 (6.8%), and 14 (6.3%) patients, in the FOLFOX4, FOLFOX4-bevacizuamb, and XELOX-bevacizumab arms, respectively (P = 0.789). Treatment arm, sex, age, histological differentiation, performance status, T/ N stages, and localization of primary tumor were independent prognostic factors of OS in stage III. CONCLUSIONS S-AVANT confirms the initial AVANT report. No benefit of the bevacizumab addition to FOLFOX4 adjuvant therapy in patients with stage III CC was observed in terms of DFS with a negative effect in OS, without increase in non-CC related deaths. CLINICAL TRIAL IDENTIFICATION NCT00112918.",2020,"CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively.","['A total of 2867 patients were randomized', 'patients with stage III CC', 'stage III colon cancer (CC', 'Patients with curatively resected stage III CC', 'colon cancer']","['FOLFOX4: n\xa0= 955, FOLFOX4-bevacizumab: n\xa0= 960, XELOX-bevacizumab', 'Bevacizumab', 'bevacizumab', 'FOLFOX4-bevacizumab', 'FOLFOX4, FOLFOX4-bevacizumab, or XELOX-bevacizumab', 'bevacizumab-Avastin® adjuVANT (AVANT', 'XELOX-bevacizumab', 'bevacizumab to oxaliplatin-based chemotherapy']","['OS and DFS hazard ratios', 'deaths', 'CC-related deaths', '10-year overall survival (OS) rates', 'Cardiovascular-related and sudden deaths', '5-year disease-free survival (DFS) rates']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",2867.0,0.262433,"CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and, Department of Medical Oncology, Saint-Antoine Hospital, Paris, France. Electronic address: thierry.andre@aphp.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, INSERM UMR 1098, Besançon, France.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bodoky', 'Affiliation': 'Department of Medical Oncology, Combined Szent István and Szent László Hospitals, Budapest, Hungary.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Buzzoni', 'Affiliation': 'Department of Medical Oncology, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Reingold', 'Affiliation': 'Department of Medical Oncology, William Osler Health Centre Brampton Civic Hospital, Brampton, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McKendrick', 'Affiliation': 'Department of Medical Oncology, Eastern Health, Box Hill Hospital, Melbourne, Australia.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Medical Oncology, Vienna General Hospital (AKH), Medizinische Universität Wien, Vienna, Austria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ravit', 'Affiliation': 'Division of Oncology, Tel Aviv Sourasky Medical Center, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountzilas', 'Affiliation': 'Department of Medical Oncology, Papageorgiou Hospital Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Yong', 'Affiliation': 'Department of Hematology-Oncology, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'Department of Medical Oncology, Palmerston North & Crest Hospitals, Palmerston North, New Zealand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Österlund', 'Affiliation': 'Department of Oncology, Helsinki and Tampere University Hospitals, University of Helsinki, Helsinki/Tampere, Finland.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rakez', 'Affiliation': 'Statistical Unit, ARCAD Foundation, Levallois-Perret, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Internal Medicine, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, Sutton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic, IOB-Quiron, CIBERONC, TTD Group, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': 'Statistical Unit, ARCAD Foundation, Levallois-Perret, France; Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.12.006'] 826,30630342,Promoting Influenza Vaccination Among an ACA Health Plan Subscriber Population: A Randomized Trial.,"PURPOSE To assess the effectiveness of an intervention to promote influenza vaccination among members of an Affordable Care Act (ACA) insurance plan. DESIGN Randomized controlled trial. SETTING Messages were delivered by a community-based, nonprofit health insurance provider to its members in Central Texas. PARTICIPANTS Adult subscribers for whom either a phone number or an e-mail address was available (n = 25 649). INTERVENTION Participants were randomly assigned to be sent (1) no messages, (2) messages encouraging influenza vaccination via e-mails and texts, and (3) messages encouraging influenza vaccination through e-mails, texts, and postal mail. Messages were sent between September 12, 2017 and November 17, 2017. MEASURES Influenza vaccination was determined using medical and pharmacy claims. ANALYSIS Rate differences and 95% confidence intervals between each exposure condition were calculated for the overall population and by subgroups. RESULTS The vaccination rate by December 31, 2017 was 16.9%. Those sent both electronic messages and postal mail were significantly more likely to be vaccinated than those who were not sent messages (rate difference: 2.5%; 95% confidence interval [CI]: 1.4-3.6) and those who were sent electronic messages only (rate difference: 1.6%; 95% CI: 0.5-2.8). CONCLUSION A combination of messages delivered via text, e-mail, and postal mail generated a modest but significant positive effect on influenza vaccine rates in an ACA plan population. The postal mail component was essential for achieving this effect.",2019,"Those sent both electronic messages and postal mail were significantly more likely to be vaccinated than those who were not sent messages (rate difference: 2.5%; 95% confidence interval [CI]: 1.4-3.6) and those who were sent electronic messages only (rate difference: 1.6%; 95% CI: 0.5-2.8). ","['\n\n\nAdult subscribers for whom either a phone number or an e-mail address was available (n = 25 649', 'members of an Affordable Care Act (ACA) insurance plan']","['no messages, (2) messages encouraging influenza vaccination via e-mails and texts, and (3) messages encouraging influenza vaccination through e-mails, texts, and postal mail', 'community-based, nonprofit health insurance provider to its members in Central Texas']","['influenza vaccine rates', 'vaccination rate', 'Influenza vaccination']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C2936611', 'cui_str': 'Affordable Care Act'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]",25649.0,0.358065,"Those sent both electronic messages and postal mail were significantly more likely to be vaccinated than those who were not sent messages (rate difference: 2.5%; 95% confidence interval [CI]: 1.4-3.6) and those who were sent electronic messages only (rate difference: 1.6%; 95% CI: 0.5-2.8). ","[{'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Nehme', 'Affiliation': '1 University of Texas Health Science Center at Tyler, Department of Community Health, Tyler, TX, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Delphia', 'Affiliation': '3 Sendero Health Plans, Austin, TX, USA.'}, {'ForeName': 'Eun Me', 'Initials': 'EM', 'LastName': 'Cha', 'Affiliation': '1 University of Texas Health Science Center at Tyler, Department of Community Health, Tyler, TX, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': '3 Sendero Health Plans, Austin, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lakey', 'Affiliation': '2 University of Texas System Population Health, Austin, TX, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118823157'] 827,31633254,Effects of ketamine and midazolam on resting state connectivity and comparison with ENIGMA connectivity deficit patterns in schizophrenia.,"Subanesthetic administration of ketamine is a pharmacological model to elicit positive and negative symptoms of psychosis in healthy volunteers. We used resting-state pharmacological functional MRI (rsPhfMRI) to identify cerebral networks affected by ketamine and compared them to the functional connectivity (FC) in schizophrenia. Ketamine can produce sedation and we contrasted its effects with the effects of the anxiolytic drug midazolam. Thirty healthy male volunteers (age = 19-37 years) underwent a randomized, three-way, cross-over study consisting of three imaging sessions, with 48 hr between sessions. A session consisted of a control period followed by infusion of placebo or ketamine or midazolam. The ENIGMA rsfMRI pipeline was used to derive two long-distance (seed-based and dual-regression) and one local (regional homogeneity, ReHo) FC measures. Ketamine induced significant reductions in the connectivity of the salience network (Cohen's d: 1.13 ± 0.28, p = 4.0 × 10 -3 ), auditory network (d: 0.67 ± 0.26, p = .04) and default mode network (DMN, d: 0.63 ± 0.26, p = .05). Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03). The effect sizes for ketamine for resting networks showed a positive correlation (r = .59, p = .07) with the effect sizes for schizophrenia-related deficits derived from ENIGMA's study of 261 patients and 327 controls. Effect sizes for midazolam were not correlated with the schizophrenia pattern (r = -.17, p = .65). The subtraction of ketamine and midazolam patterns showed a significant positive correlation with the pattern of schizophrenia deficits (r = .68, p = .03). RsPhfMRI reliably detected the shared and divergent pharmacological actions of ketamine and midazolam on cerebral networks. The pattern of disconnectivity produced by ketamine was positively correlated with the pattern of connectivity deficits observed in schizophrenia, suggesting a brain functional basis for previously poorly understood effects of the drug.",2020,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","['261 patients and 327 controls', 'Thirty healthy male volunteers (age = 19-37\u2009years', 'schizophrenia', 'healthy volunteers']","['midazolam', 'Midazolam', 'Ketamine', 'ketamine', 'placebo or ketamine or midazolam', 'ketamine and midazolam', 'resting-state pharmacological functional MRI (rsPhfMRI']","['schizophrenia pattern', 'auditory network', 'schizophrenia deficits', 'connectivity of the salience network', 'cerebral networks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.077698,"Midazolam significantly reduced connectivity in the DMN (d: 0.77 ± 0.27, p = .03).","[{'ForeName': 'Bhim M', 'Initials': 'BM', 'LastName': 'Adhikari', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Joerg F', 'Initials': 'JF', 'LastName': 'Hipp', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, Basel, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Meghann C', 'Initials': 'MC', 'LastName': 'Ryan', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'L Elliot', 'Initials': 'LE', 'LastName': 'Hong', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Eickhoff', 'Affiliation': 'Institute of Neuroscience and Medicine, Brain & Behaviour (INM-7), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Jahandshad', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Thompson', 'Affiliation': 'Imaging Genetics Center, Mark & Mary Stevens Neuroimaging & Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, California.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Rowland', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kochunov', 'Affiliation': 'Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.'}]",Human brain mapping,['10.1002/hbm.24838'] 828,31899371,Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women.,"INTRODUCTION Physical activity monitors, motivational text messages, personal calls, and group meetings, have proven to be efficacious physical activity interventions. However, individual participant response to these interventions varies drastically. A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders. We describe a SMART to determine the most effective adaptive intervention to increase physical activity (steps, moderate-to-vigorous physical activity) and improve cardiovascular health among employed women who are not regularly physically active. The SMART uses combinations of four treatments: 1) enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings. METHODS Participants (N = 312) include women ages 18-70 employed at a large academic medical center. Women will be randomized to an initial intervention, either an enhanced physical activity monitor or enhanced physical activity monitor + text messaging. Non-responders to the initial intervention at 2 months will be randomized to either personal calls or groups meetings for the next 6 months. At 8 months, all participants will return to only an enhanced physical activity monitor until their final 12-month assessment. DISCUSSION Results of this study will add to the literature on improving physical activity in employed women. This study will identify effective interventions for women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.",2020,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"['women who respond to less intensive treatments', 'employed women who are not regularly physically active', 'employed women', 'Participants (N\u202f=\u202f312) include women ages 18-70 employed at a large academic medical center']","['enhanced physical activity monitor or enhanced physical activity monitor\u202f+\u202ftext messaging. Non-responders to the initial intervention', 'enhanced physical activity monitor (Fitbit wearable activity monitor and mobile app with goal setting and physical activity prescription), 2) text messages, 3) personal calls, and 4) group meetings']","['cardiovascular health', 'physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",70.0,0.0342475,A SMART design (sequential multiple assignment randomized trial) provides an effective way to test interventions that start with an initial treatment and then transition to an augmented treatment for non-responders.,"[{'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Buchholz', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America. Electronic address: susan_buchholz@rush.edu.'}, {'ForeName': 'JoEllen', 'Initials': 'J', 'LastName': 'Wilbur', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Halloway', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schoeny', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Rush University, College of Health Sciences, Chicago, IL, United States of America.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Vispute', 'Affiliation': 'Rush University, College of Nursing, Chicago, IL, United States of America.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kitsiou', 'Affiliation': 'University of Illinois at Chicago, College of Applied Health Sciences, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105921'] 829,31977308,"A randomized, crossover trial comparing the efficacy and safety of fesoterodine and extended-release oxybutynin in children with overactive bladder with 12-month extension on fesoterodine: The FOXY study.","INTRODUCTION We sought to assess and compare safety and efficacy of fesoterodine and oxybutynin extended-release in the treatment of pediatric overactive bladder (OAB). METHODS We conducted a non-inferiority, randomized, double-blind, crossover trial comparing fesoterodine 4-8 mg and oxybutynin 10-20 mg once daily (QD) in children with OAB aged 5-14 years (2015-2018). Every child received the first medication for eight weeks, followed by crossover to the second antimuscarinic after a three-days washout. Dose up-titration was possible at mid-course. Patients could enter a fesoterodine 12-month extension. Endpoints were assessed through changes on voiding diaries, Patient's Perception of Bladder Condition score (PPBC), adverse events, vital signs, electrocardiogram, post-void residual, urinalysis, and blood tests. The Wilcoxon rank sum and Wilcoxon signed rank tests were used for statistical analysis. RESULTS A total of 62 patients were randomized (two early dropouts). Expected class effects (dry mouth/constipation) were present but no significant difference was observed. There was a 10.1 beats/minute increase in heart rate with fesoterodine (p<0.01) (oxybutynin-1.9 beats/min; p=non-significant [ns]). No life-threatening or serious adverse events occurred. Efficacy was similar for both drugs. Bladder capacity improved over the 16 months of the study; baseline capacity of 125 mL (44.5% expected bladder capacity for age [%EBC]) to 171 mL (53.9 %EBC) at the end of the extension phase. No clinical or statistical difference was shown between efficacy measures for fesoterodine or oxybutynin. CONCLUSIONS The use of fesoterodine or oxybutynin appear safe and effective for the treatment of OAB in children. Based on our study, long-term treatment to achieve the ultimate goal of urinary continence is needed in this population.",2020,Bladder capacity improved over the 16 months of the study; baseline capacity of 125 mL (44.5% expected bladder capacity for age [%EBC]) to 171 mL (53.9%EBC) at the end of the extension phase.,"['children with OAB aged 5-14 years (2015-2018', 'children', '62 patients', 'pediatric overactive bladder (OAB', 'children with overactive bladder with 12-month extension on']","['fesoterodine or oxybutynin', 'fesoterodine and extended-release oxybutynin', 'fesoterodine 4-8 mg and oxybutynin 10-20 mg QD', 'fesoterodine']","['heart rate', 'efficacy and safety', 'Bladder capacity', 'No life-threatening or serious adverse events', 'safety and efficacy', ""voiding diaries, Patient's Perception of Bladder Condition score (PPBC), adverse events, vital signs, electrocardiogram, post-void residual, urinalysis, and blood tests"", 'Efficacy', 'class effects (dry mouth/constipation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0069805', 'cui_str': 'oxybutynin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429807', 'cui_str': 'Bladder capacity (observable entity)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",62.0,0.130768,Bladder capacity improved over the 16 months of the study; baseline capacity of 125 mL (44.5% expected bladder capacity for age [%EBC]) to 171 mL (53.9%EBC) at the end of the extension phase.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ramsay', 'Affiliation': 'Division of Urology, CHU de Québec - Université Laval Research Centre, Quebec City, QC, Canada.'}, {'ForeName': 'Élizabeth', 'Initials': 'É', 'LastName': 'Naud', 'Affiliation': 'Division of Urology, CHU de Québec - Université Laval Research Centre, Quebec City, QC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simonyan', 'Affiliation': 'Division of Urology, CHU de Québec - Université Laval Research Centre, Quebec City, QC, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Division of Urology, CHU de Québec - Université Laval Research Centre, Quebec City, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bolduc', 'Affiliation': 'Division of Urology, CHU de Québec - Université Laval Research Centre, Quebec City, QC, Canada.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6247'] 830,31129812,"Selenium supplementation in the management of thyroid autoimmunity during pregnancy: results of the ""SERENA study"", a randomized, double-blind, placebo-controlled trial.","PURPOSE Selenium is frequently in nutraceuticals for pregnancy, given its role on fertility and thyroid metabolism. However, most evidence rise from non-controlled studies. We aimed to evaluate the protective effect of selenium against thyroid autoimmunity during and after pregnancy. METHODS A multicenter, randomized, double-blind, placebo-controlled trial was performed and promoted by the Young Italian Endocrinologists Group (EnGioI)-Italian Society of Endocrinology. Forty-five women with thyroiditis in pregnancy were enrolled and randomly assigned to L-selenomethionine (L-Se-Met) 83 mcg/day or placebo (PLB) and evaluated at 10 ± 2 (T1), 36 ± 2 weeks of gestation (T2) and 6 months after delivery (postpartum, PP). RESULTS We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01], and an antibodies titer's rebound in PLB group (TgAb 151.03 ± 182.9, p < 0.01; TPOAb 441.28 ± 512.18, p < 0.01). A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02). Two miscarriage occurred in PLB. No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications. CONCLUSIONS SERENA study demonstrated a beneficial effect of L-Se-Met supplementation on autoantibody titer during pregnancy and on postpartum thyroiditis recurrence.",2019,"No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications. ","['thyroid autoimmunity during pregnancy', 'Young Italian Endocrinologists Group (EnGioI)-Italian Society of Endocrinology', 'Forty-five women with thyroiditis in pregnancy']","['L-selenomethionine (L-Se-Met) 83\u2009mcg/day or placebo (PLB', 'Selenium supplementation', 'placebo']","['selenemia', 'autoantibodies', 'autoantibody titer', ""antibodies titer's rebound"", 'thyroid volume, echogenicity, quality of life, maternal/fetal complications']","[{'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3838854', 'cui_str': 'Thyroiditis in pregnancy'}]","[{'cui': 'C0036584', 'cui_str': 'Selenomethionine'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}]","[{'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0474521', 'cui_str': 'Autoantibody titer measurement'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0851390', 'cui_str': 'Foetal complications'}]",45.0,0.575627,"No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications. ","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mantovani', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Endocrine Unit - Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Moretti', 'Affiliation': 'Department of Internal Medicine, ""Tor Vergata"" University of Rome, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Di Dato', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Greco', 'Affiliation': 'Reproductive Medicine and Biology Center, ""European Hospital"" of Rome, Rome, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ciolli', 'Affiliation': 'Department of Gynecological Sciences - Obstetric and Urological Sciences, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bonomi', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Petrone', 'Affiliation': 'Department of Endocrinology, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fumarola', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Campagna', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vannucchi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Endocrine Unit - Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Di Sante', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pozza', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Faggiano', 'Affiliation': 'Thyroid and Parathyroid Surgery Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori ""Fondazione G. Pascale"", IRCCS, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lenzi', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Giannetta', 'Affiliation': 'Department of Experimental Medicine, ""Sapienza"" University of Rome, Rome, Italy. elisa.giannetta@uniroma1.it.'}]",Endocrine,['10.1007/s12020-019-01958-1'] 831,30346877,"Assay sensitivity in ""Hybrid thorough QT/QTc (TQT)"" study.","A concurrent positive control should be included in a thorough QTc clinical trial to validate the study according to ICH E14 guidance. Some pharmaceutical companies have started to use ""hybrid TQT"" study to meet ICH E14 regulatory requirements since the release of ICH E14 Q&A (R3). The ""hybrid TQT"" study includes the same treatment arms (therapeutic and/or supratherapeutic dose of investigational drug, placebo, and positive control) with sample size less than traditional TQT studies, but use concentration-QTc (C-QTc) analysis as primary analysis and assay sensitivity analysis. To better understand the statistical characteristics of assay sensitivity with a commonly used positive control - Moxifloxacin - in ""hybrid TQT"" studies, we examined the original and subsampled moxifloxacin and placebo data from more than a hundred of TQT studies submitted to FDA. The assay sensitivity results are quite consistent between classical E14 analysis and C-QTc analysis using the original datasets. Performance of assay sensitivity in ""hybrid TQT"" studies using subsampled data depends on number of moxifloxacin subjects, study design (crossover design and parallel design), and C-QTc model. The results presented here can aid the design of future ""hybrid TQT"" studies.",2019,The assay sensitivity results are quite consistent between classical E14 analysis and C-QTc analysis using the original datasets.,[],['moxifloxacin and placebo'],['Assay sensitivity'],[],"[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.0325592,The assay sensitivity results are quite consistent between classical E14 analysis and C-QTc analysis using the original datasets.,"[{'ForeName': 'Dalong Patrick', 'Initials': 'DP', 'LastName': 'Huang', 'Affiliation': 'a Office of Biostatistics, Office of Translational Sciences, CDER, FDA.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'a Office of Biostatistics, Office of Translational Sciences, CDER, FDA.'}, {'ForeName': 'Qianyu', 'Initials': 'Q', 'LastName': 'Dang', 'Affiliation': 'a Office of Biostatistics, Office of Translational Sciences, CDER, FDA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tsong', 'Affiliation': 'a Office of Biostatistics, Office of Translational Sciences, CDER, FDA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2018.1535498'] 832,31929401,Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women.,"BACKGROUND Young women aged 15-24 years are disproportionately affected by the HIV epidemic. Two phase III trials of a vaginal ring containing 25-mg dapivirine demonstrated HIV-1 risk reduction in adult women older than 21 years but not in those aged 18-21 years. Lack of protection was correlated with low adherence. METHODS In this phase-IIa, randomized, double-blind, placebo-controlled, US, multicenter trial of the dapivirine ring in sexually active females, aged 15-17 years, participants were randomized 3:1 to a dapivirine or placebo ring to be inserted monthly for 6 months (NCT02028338). Primary safety end points included grade 2 product related adverse events and any grade 3 and higher adverse events. Adherence to ring use was assessed by plasma dapivirine concentrations, residual levels in used rings, and self-report. A plasma dapivirine concentration of >95 pg/mL was used to define short-term adherence; a residual ring level of <23.5 mg was used to define long-term adherence. Acceptability was assessed through computer-assisted self-interviews. RESULTS Ninety-six participants were enrolled across 6 US sites. The median age was 16.0 years. There were no differences in safety outcomes between treatment arms. Adherence to the dapivirine ring was demonstrated by both plasma measurements (87%) and residual drug levels in rings (95%). Forty-two percent (95% confidence interval: 32 to 52) of participants reported that they never removed the ring. Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. CONCLUSION The dapivirine vaginal ring, a promising topical microbicide, was well tolerated and acceptable in young US adolescents.",2020,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. ","['adult women older than 21 years but not in those aged 18-21 years', 'sexually active females, aged 15-17 years', 'Ninety-six participants were enrolled across 6 US sites', 'Forty-two percent', 'Adolescent Young Women', 'young US adolescents', 'Young women aged 15-24 years']","['vaginal ring containing 25-mg dapivirine', 'placebo', 'dapivirine or placebo', 'Vaginal Ring Containing Dapivirine', 'dapivirine ring']","['HIV-1 risk reduction', 'safety outcomes', 'grade 2 product related adverse events and any grade 3 and higher adverse events', 'plasma dapivirine concentrations, residual levels in used rings, and self-report', 'residual drug levels', 'Acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",96.0,0.367086,"Participants noted no discomfort due to the ring at 87% of visits and ""liking"" the ring at 93% of visits. ","[{'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Bunge', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Szydlo', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fred Hutchinson Cancer Research Center- Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Aditya H', 'Initials': 'AH', 'LastName': 'Gaur', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reirden', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Boston, MA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Futterman', 'Affiliation': ""Department of Pediatrics, Children's Hospital at Montefiore Medical Center, The Bronx, NY.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hoesley', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pamina M', 'Initials': 'PM', 'LastName': 'Gorbach', 'Affiliation': 'Department of Epidemiology, University of California at Los Angeles Fielding School of Public Health, Los Angeles, CA.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Kapogiannis', 'Affiliation': 'Maternal and Pediatric Infectious Disease Branch, National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Squires', 'Affiliation': 'Merck Research Labs, Rahway, NJ.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002244'] 833,31926605,"Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Intravenous Siponimod: A Randomized, Open-label Study in Healthy Subjects.","PURPOSE The goal of this study was to assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of intravenous (IV) siponimod in healthy subjects. METHODS This randomized, open-label study was conducted in 2 parts. In Part 1, a total of 16 eligible subjects received either a single oral dose of siponimod (0.25 mg) followed by a single IV infusion (0.25 mg/3 h) in Sequence 1, or vice versa in Sequence 2. In Part 2, a total of 17 eligible subjects received single IV infusions of siponimod (1 mg/24 h). FINDINGS No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min. Observed atrioventricular blocks and sinus pauses were asymptomatic. The mean change in absolute lymphocyte count from baseline was comparable for the siponimod 0.25 mg oral regimen and the two IV siponimod regimens. Oral siponimod displayed a good absolute bioavailability of 84%. The mean peak exposure of oral siponimod was approximately 48% lower than that of IV siponimod. The M17 metabolite was found to be the most prominent systemic metabolite of siponimod in humans. IMPLICATIONS Siponimod IV infusions were well tolerated, with safety and PD (absolute lymphocyte count) profiles similar to those of oral siponimod. The PD/PK findings supported the development of an innovative rapid IV titration regimen for patients with intracerebral hemorrhage.",2020,"FINDINGS No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min.","['Healthy Subjects', '17 eligible subjects received', 'healthy subjects', 'patients with intracerebral hemorrhage', '16 eligible subjects']","['single IV infusions of siponimod', 'single oral dose of\xa0siponimod', 'Intravenous Siponimod', 'intravenous (IV) siponimod']","['mean 5-minute or hourly average heart rate', 'Safety, Tolerability, Pharmacodynamics and Pharmacokinetics', 'mean change in absolute lymphocyte count', 'mean peak exposure of oral siponimod', 'safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3657824', 'cui_str': '1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3657824', 'cui_str': '1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid'}]",,0.022533,"FINDINGS No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min.","[{'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Shakeri-Nejad', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland. Electronic address: kasra.shakeri-nejad@novartis.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardin', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Neelakantham', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Dumitras', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Legangneux', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.014'] 834,31926597,Evaluation of emergence agitation after general anaesthesia in rhinoplasty patients: Inhalation anaesthesia versus total intravenous anaesthesia.,"BACKGROUND Emergence agitation (EA) is a clinical condition that occurs early in recovery from general anaesthesia, and reduces patient comfort. The aim of this study was to compare the effects of low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA) on agitation in rhinoplasty patients, and to determine the frequency of EA in low flow sevoflurane anaesthesia after rhinoplasty. MATERIAL AND METHODS A total of 90 rhinoplasty patients, under general anaesthesia were included in this prospective randomised study. After induction of anaesthesia, propofol infusion was initiated in the TIVA group (n = 45), and sevoflurane was administered in the SEVO group with a fresh gas flow of 1 l/min and MAC (minimum alveolar concentration) 1-1.1 (n = 45). Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting were recorded at the end of surgery. RESULTS Early emergence time was significantly shorter in the TIVA group, than in the SEVO group (p < 0.001). İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001). The ratio of patients with RASS > +1 for all patients was 35.6% at 0 min, postoperatively. This rate was 12.2% (n = 11) in the TIVA group, and 23.3% (n = 21) in the SEVO group (p = 0.028). CONCLUSIONS In rhinoplasty, TIVA caused shorter early emergence times, less bleeding, high surgeon satisfaction, and lower EA scores when compared with low flow sevoflurane anaesthesia.",2020,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","['90 rhinoplasty patients, under general anaesthesia', 'rhinoplasty patients']","['sevoflurane', 'anaesthesia, propofol infusion', 'anaesthesia versus total intravenous anaesthesia', 'low-flow sevoflurane anaesthesia and total intravenous anaesthesia (TIVA']","['Early emergence times, Richmond agitation-sedation scale (RASS), Boezaart scale, Likert scale and incidences of nausea/vomiting', 'surgical field image quality and surgeon satisfaction', 'bleeding, high surgeon satisfaction, and lower EA scores', 'İntraoperative bleeding']","[{'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0222045'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0313933,"İntraoperative bleeding was significantly lower in the TIVA group, than in the SEVO group (p = 0.005), and surgical field image quality and surgeon satisfaction were better in the TIVA group (p = 0.016, p < 0.001).","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Talih', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey. Electronic address: gamzetalih@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yüksek', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Şahin', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Bozok University Yozgat, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102387'] 835,31942918,Efficacy of an m-Health Physical Activity and Sleep Intervention to Improve Sleep Quality in Middle-Aged Adults: The Refresh Study Randomized Controlled Trial.,"BACKGROUND Poor sleep health is highly prevalent. Physical activity is known to improve sleep quality but not specifically targeted in sleep interventions. PURPOSE To compare the efficacy of a combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control, for improving sleep quality in middle-aged adults without a diagnosed sleep disorder. METHODS Three-arm randomized controlled trial (Physical Activity and Sleep Health (PAS), Sleep Health Only (SO), Wait-list Control (CON) groups; 3-month primary time-point, 6-month follow-up) of 275 (PAS = 110, SO = 110, CON = 55) inactive adults (40-65 years) reporting poor sleep quality. The main intervention component was a smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group. Primary outcome was Pittsburgh Sleep Quality Index (PSQI) global score. Secondary outcomes included several self-reported physical activity measures and PSQI subcomponents. Group differences were examined stepwise, first between pooled intervention (PI = PAS + SO) and CON groups, then between PAS and SO groups. RESULTS Compared with CON, PI groups significantly improved PSQI global and subcomponents scores at 3 and 6 months. There were no differences in sleep quality between PAS and SO groups. The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group. CONCLUSIONS PIs had statistically significantly improved sleep quality among middle-aged adults with poor sleep quality without a diagnosed sleep disorder. The adjunctive physical activity intervention did not additionally improve sleep quality. CLINICAL TRIAL INFORMATION Australian New Zealand Clinical Trial Registry: ACTRN12617000680369; Universal Trial number: U1111-1194-2680; Human Research Ethics Committee, Blinded by request of journal: H-2016-0267.",2020,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group. ","['Australian New Zealand Clinical Trial Registry', 'middle-aged adults with poor sleep quality without a diagnosed sleep disorder', 'middle-aged adults without a diagnosed sleep disorder', 'Middle-Aged Adults']","['combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control', 'm-Health Physical Activity and Sleep Intervention', 'Physical Activity and Sleep Health (PAS), Sleep Health Only (SO', 'adjunctive physical activity intervention', 'Wait-list Control (CON', 'smartphone/tablet ""app"" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group', 'CON']","['Pittsburgh Sleep Quality Index (PSQI) global score', 'poor sleep quality', 'Sleep Quality', 'several self-reported physical activity measures and PSQI subcomponents', 'sleep quality', 'PSQI global and subcomponents scores', 'daily sitting time']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.106602,"The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report ≥2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group. ","[{'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Rayward', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Murawski', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Holliday', 'Affiliation': 'School of Medicine & Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'Physical Activity Research Group, School for Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Brown', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Plotnikoff', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz064'] 836,31888939,Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.,"INTRODUCTION Chronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments. METHODS AND ANALYSIS Participants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+ web. All participants will receive the usual treatment for their pain. Only the TAU +app+ web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition. ETHICS AND DISSEMINATION Ethical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03606265.",2019,"Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected.","['Participants will be 250 patients randomly assigned to one of these two conditions', 'pain telemonitoring consisting of a smartphone app for patients and a web application for physicians', 'chronic pain patients']","['treatment-as-usual (TAU) and TAU +app+\u2009web', 'technology-based solution']","['secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",250.0,0.136502,"Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jaén', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain ijaen@uji.es.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Psychology and Sociology, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragoza', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERobn, CB06/03, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Gómez Palones', 'Affiliation': 'Pain Clinic, Hospital General de Castellon, Castellon de la Plana, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-033586'] 837,31888941,Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study.,"INTRODUCTION Many young adult female (YA-F) cancer survivors who received gonadotoxic therapy will experience fertility problems. After cancer, having a child will often require assisted reproductive technology (ART), surrogacy or adoption. However, there are significant informational, psychosocial, financial and logistical barriers to pursuing these options. Survivors report high rates of decision uncertainty and distress related to family-building decisions. The aim of this study is to pilot test a web-based decision aid and planning tool for family-building after cancer. METHODS AND ANALYSIS The pilot study will use a single-arm trial design to test the feasibility and acceptability (aim 1) and obtain effect size estimates of the decision support intervention (aim 2). The target sample size is 100. Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building. A longitudinal prepost design will be conducted. Participants will complete three psychosocial assessment surveys over a 3-month time period to track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes). After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website. Postintervention surveys will be administered at 1-month (T2) and 3-month (T3) follow-up time points. Feasibility and acceptability metrics will be analysed. Pairwise t-tests will test mean scores of outcome variables from T1 to T2. Effect size estimates (Cohen's d) will be calculated. Google analytics will evaluate user engagement with the website over the study period. Baseline and follow-up data will examine measures of feasibility, acceptability and intervention effect size. ETHICS AND DISSEMINATION This will be the first test of a supportive intervention to guide YA-F cancer survivors in family-building decisions and early planning. Study findings will inform intervention development. Future directions will include a randomised controlled trial to test intervention efficacy over a longer time period. TRIAL REGISTRATION NUMBER NCT04059237; Pre-results.",2019,"After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website.","['Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building', 'family-building after cancer', 'young adult women after cancer treatment', 'young adult female (YA-F) cancer survivors']","['supportive intervention', 'gonadotoxic therapy']","['Feasibility and acceptability metrics', 'track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444661', 'cui_str': 'Not completed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.122292,"After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA cbenedict@stanford.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ford', 'Affiliation': 'Hunter College and The Graduate Center, City University of New York (CUNY), New York City, New York, USA.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Schapira', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Diefenbach', 'Affiliation': 'Center for Health Innovation and Outcomes Research, Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033630'] 838,31880055,Inflammatory markers IL-1β and RANK-L assessment after non-vital bleaching: A 3-month follow-up.,"OBJECTIVE This study assessed IL-1β and RANK-L levels in vivo and color stability of non-vital teeth bleached using hydrogen (35%) and carbamide (37%) peroxides 3 months after treatment. MATERIALS AND METHODS Fifty teeth were randomly divided into two groups(n = 25):35% hydrogen peroxide (HP) or 37% carbamide peroxide (CP). Four sessions of intracoronal walking-bleach procedure were performed. IL-1β and RANK-L levels were assessed from gingival crevicular fluid samples (from three vestibular and three palatines sites) at eight different time-points: at the beginning of the study (baseline), after four sessions of intracanal bleaching, and at 1 week, 1 month, and 3 months posttreatment. The color variations were visually detected using Vita bleach shade guide (ΔSGU). RESULTS Significant increases of IL-1β and RANK-L levels were detected at all time-points (all P < .05) when comparing each time-point to baseline, and a high correlation (>0.8-Spearman) between variables. According the ΔSGU values, a color change of five for HP and four for CP were detected. CONCLUSIONS Non-vital walking bleach technique promotes an increase in IL-1β and RANKL levels in periodontal tissues and also, it is maintained until the third-month posttreatment. CLINICAL SIGNIFICANCE The internal whitening of teeth increases the levels of cytokines associated with inflammation and bone resorption 3 months after the whitening procedure is finished; this should warn of possible harmful effects of this whitening technique.",2020,The internal whitening of teeth increases the levels of cytokines associated with inflammation and bone resorption 3 months after the whitening procedure is finished; this should warn of possible harmful effects of this whitening technique.,"['after non-vital bleaching', 'Fifty teeth']",['groups(n = 25):35% hydrogen peroxide (HP) or 37% carbamide peroxide (CP'],"['Inflammatory markers IL-1β and RANK-L assessment', 'IL-1β and RANK-L levels']","[{'cui': 'C0442741', 'cui_str': 'Non-vital (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",50.0,0.0212562,The internal whitening of teeth increases the levels of cytokines associated with inflammation and bone resorption 3 months after the whitening procedure is finished; this should warn of possible harmful effects of this whitening technique.,"[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Bersezio', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Sánchez', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Estay', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Ledezma', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Vernal', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Garlet', 'Affiliation': 'School of Dentistry of Bauru, FOB/USP, Bauru, Brazil.'}, {'ForeName': 'Osmir Batista', 'Initials': 'OB', 'LastName': 'Oliveira', 'Affiliation': 'Departament of Restorative Dentistry, Faculty of Dentistry, UNESP, Araraquara, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12557'] 839,30765288,Video-Delivered Relaxation Intervention Reduces Late-Life Anxiety: A Pilot Randomized Controlled Trial.,"OBJECTIVE The study's aim was to demonstrate the feasibility and preliminary efficacy of a 4-week video-delivered relaxation program called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE) for reducing anxiety and increasing activity engagement in older adults with anxiety disorders. METHODS This was an 8-week pilot randomized controlled trial performed as outpatient and self-directed learning at home among 40 community-dwelling adults aged 60years or older who met criteria for an anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, or anxiety disorder unspecified). The study looked at the BREATHE intervention compared with a wait list control condition. The primary outcome measure was anxiety symptoms (Geriatric Anxiety Scale). Secondary outcomes included activity engagement (modified Activity Card Sort), depressive symptoms (Patient Health Questionnaire), and somatic symptoms (Somatic Symptom Scale). RESULTS In linear mixed-effects models, findings indicated a significant reduction in anxiety symptoms. There was no significant effect of group on activity engagement. Results also showed significant reductions in depressive and somatic symptoms associated with the BREATHE intervention compared with wait list. CONCLUSION Our findings demonstrate feasibility and preliminary efficacy for this brief video-delivered relaxation intervention and suggest that older adults can benefit from technology-delivered interventions with minimal provider contact. Although activity engagement did not improve, lessons learned suggest that targeted coaching around activity goals may help target this outcome.",2019,There was no significant effect of group on activity engagement.,"['older adults with anxiety disorders', '40 community-dwelling adults aged 60years or older who met criteria for an anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, or anxiety disorder unspecified', 'older adults']","['Video-Delivered Relaxation Intervention', 'outpatient and self-directed learning at home', '4-week video-delivered relaxation program called Breathing, Relaxation, and Education for Anxiety Treatment', 'relaxation intervention']","['anxiety symptoms (Geriatric Anxiety Scale', 'activity engagement (modified Activity Card Sort), depressive symptoms (Patient Health Questionnaire), and somatic symptoms (Somatic Symptom Scale', 'depressive and somatic symptoms', 'Late-Life Anxiety', 'anxiety symptoms', 'activity engagement']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0475668', 'cui_str': 'Relaxation program (regime/therapy)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4318612', 'cui_str': 'ACS - Activity Card Sort'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",40.0,0.0495616,There was no significant effect of group on activity engagement.,"[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Gould', 'Affiliation': 'Palo Alto Geriatric Research, Education, and Clinical Center (CEG, BCK, VKM), VA Palo Alto Health Care System, Palo Alto, CA; Department of Psychiatry and Behavioral Sciences (CEG, KS, SAB), Stanford University School of Medicine, Stanford, CA. Electronic address: cegould@stanford.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Kok', 'Affiliation': 'Palo Alto Geriatric Research, Education, and Clinical Center (CEG, BCK, VKM), VA Palo Alto Health Care System, Palo Alto, CA; Pacific Graduate School of Psychology (BCK, VKM), Palo Alto University, Palo Alto, CA.'}, {'ForeName': 'Vanessa K', 'Initials': 'VK', 'LastName': 'Ma', 'Affiliation': 'Palo Alto Geriatric Research, Education, and Clinical Center (CEG, BCK, VKM), VA Palo Alto Health Care System, Palo Alto, CA; Pacific Graduate School of Psychology (BCK, VKM), Palo Alto University, Palo Alto, CA.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Psychology Service (JLW), VA San Diego Healthcare System, San Diego, CA; Department of Psychiatry (JLW), University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Sudheimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences (CEG, KS, SAB), Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Beaudreau', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences (CEG, KS, SAB), Stanford University School of Medicine, Stanford, CA; Mental Illness Research Education and Clinical Center (SAB), VA Palo Alto Health Care System, Palo Alto, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2018.12.018'] 840,31862740,Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study.,"OBJECTIVE To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. DESIGN Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. SETTING Patients treated by paramedics in the catchment area of one emergency department in South Wales. PARTICIPANTS Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). INTERVENTION FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards. OUTCOMES Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. RESULTS Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. CONCLUSIONS This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting. TRIAL REGISTRATION NUMBER ISRCTN60065373.",2019,This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture.,"[""patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury"", 'Patients treated by paramedics in the catchment area of one emergency department in South Wales', 'Patients had little or no memory of being offered, consenting to or receiving FICB', 'Six patients and one carer of a patient who received fascia iliaca compartment block (FICB', 'patients with suspected hip fracture', 'people with suspected hip fracture']","['FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards', 'FICB']","['Acceptability and experience of receiving FICB, assessed through interview data', 'safety, effectiveness and cost effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks (finding)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0850592,This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture.,"[{'ForeName': 'Bridie Angela', 'Initials': 'BA', 'LastName': 'Evans', 'Affiliation': 'Medical School, Swansea University, Swansea, UK b.a.evans@swansea.ac.uk.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Public contributor c/o Swansea University, Swansea, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fegan', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ford', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Guy', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Public contributor c/o Swansea University, Swansea, UK.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Keen', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, UK.'}, {'ForeName': 'Ashrafunnesa', 'Initials': 'A', 'LastName': 'Khanom', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pallister', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Russell', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Seagrove', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Medical School, Swansea University, Swansea, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033398'] 841,30277420,Distinct Effects of Repeated-Sprint Training in Normobaric Hypoxia and β-Alanine Supplementation.,"OBJECTIVE The present study evaluated the effects of repeated-sprint training in normobaric hypoxia and β-alanine supplementation (BA) on aerobic and anaerobic performance in recreationally active men. METHODS Participants were randomly assigned to one of the following groups: normoxia/β-alanine (NB, n = 11), normoxia/placebo (NP, n = 8), normobaric hypoxia/β-alanine (HB, n = 10) and normobaric hypoxia/placebo (HP, n = 9). All participants completed 8 training sessions over 4 weeks on a cycle ergometer either in normobaric hypoxia (oxygen fraction: FiO 2  = 14.2%) or normoxia (FiO 2  = 20.9%). Participants were instructed to consume a daily dosage of 6.4 g of BA or placebo. Changes in performance in a graded exercise test, repeated-sprint test (RST), and 3-minute all-out test (3MT) were examined before and after training and supplementation. RESULTS No between-group differences were observed for training volume or supplementation compliance. Anthropometric and hematological measures remained unchanged before and after intervention in all groups. A main effect of training condition was shown for oxygen consumption and power output at respiratory compensation point, average power output during the last sprint of the RST, heart rate recovery following the RST, and total work during the 3MT. These measures in the normobaric hypoxia groups were significantly (p < 0.05) higher than the normoxia groups, except for the heart rate recovery following the RST. A main effect of supplement was detected in anaerobic working capacity, with postintervention values in the BA groups being significantly (p < 0.05) higher than the placebo groups. CONCLUSIONS Repeated-sprint training in hypoxia improved aerobic performance, exercise tolerance, cardiovascular recovery, and overall working capacity, while BA maintained the anaerobic working capacity. However, BA did not provide additional benefits with respect to attenuating fatigue or enhancing repeated-sprint performance.",2019,"These measures in the normobaric hypoxia groups were significantly (p < 0.05) higher than the normoxia groups, except for the heart rate recovery following the RST.","['recreationally active men', 'Participants']","['repeated-sprint training in normobaric hypoxia and β-alanine supplementation (BA', 'cycle ergometer either in normobaric hypoxia (oxygen fraction: FiO 2 \u2009=\u200914.2%) or normoxia', 'placebo', 'Repeated-sprint training', 'Repeated-Sprint Training', 'graded exercise test, repeated-sprint test (RST), and 3-minute all-out test (3MT', 'normoxia/β-alanine (NB, n\u2009=\u200911), normoxia/placebo (NP, n\u2009=\u20098), normobaric hypoxia/β-alanine (HB, n\u2009=\u200910) and normobaric hypoxia/placebo (HP, n\u2009=\u20099', 'BA or placebo']","['anaerobic working capacity', 'aerobic performance, exercise tolerance, cardiovascular recovery, and overall working capacity, while BA maintained the anaerobic working capacity', 'training volume or supplementation compliance', 'Anthropometric and hematological measures', 'aerobic and anaerobic performance', 'heart rate recovery', 'oxygen consumption and power output at respiratory compensation point, average power output during the last sprint of the RST, heart rate recovery']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",,0.151976,"These measures in the normobaric hypoxia groups were significantly (p < 0.05) higher than the normoxia groups, except for the heart rate recovery following the RST.","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'a School of Physical Education and Sport Training , Shanghai University of Sport , Shanghai , China.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'b School of Kinesiology and Physical Therapy , University of Central Florida , Orlando , Florida , USA.'}, {'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Hoffman', 'Affiliation': 'b School of Kinesiology and Physical Therapy , University of Central Florida , Orlando , Florida , USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'La Monica', 'Affiliation': 'b School of Kinesiology and Physical Therapy , University of Central Florida , Orlando , Florida , USA.'}, {'ForeName': 'Tristan M', 'Initials': 'TM', 'LastName': 'Starling', 'Affiliation': 'b School of Kinesiology and Physical Therapy , University of Central Florida , Orlando , Florida , USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'b School of Kinesiology and Physical Therapy , University of Central Florida , Orlando , Florida , USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'c Department of Health & Exercise Science , The College of New Jersey , Ewing Township , New Jersey , USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'd Sport Science Research Center , Beijing Sport University , Beijing , China.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1475269'] 842,30822290,Feasibility and Preliminary Effects of a Telerehabilitation Program for People Living With HIV: A Pilot Randomized Study.,"We investigated feasibility and preliminary effects of telerehabilitation for people living with HIV (PLWH) and taking antiretroviral therapy. We randomized 25 PLWH to either an endurance and resistance training exercise (ERTE) group or a control group. Endurance and resistance training exercise sessions occurred in a public fitness center, with online guidance and weekly telephone advice. The primary outcome was feasibility (recruitment and retention rates and safety). Secondary outcomes were assessed at baseline and 6 weeks according to the three International Classification of Functioning, Disability, and Health domains. Nine patients completed the ERTE program. Recruitment and retention rates were 93% and 69%, respectively. No adverse events occurred. After 6 weeks, percentage change in D-dimer was lower in the ERTE group, but not significantly after the Bonferroni correction. Other parameters were not different between the groups. Therefore, telerehabilitation is feasible in PLWH taking antiretroviral therapy; however, the performance of the program is still questioned, and future research is warranted.",2019,"After 6 weeks, percentage change in D-dimer was lower in the ERTE group, but not significantly after the Bonferroni correction.","['People Living With HIV', 'people living with HIV (PLWH) and taking antiretroviral therapy']","['endurance and resistance training exercise (ERTE', 'Endurance and resistance training exercise sessions', 'Telerehabilitation Program']","['percentage change in D-dimer', 'feasibility (recruitment and retention rates and safety', 'Recruitment and retention rates', 'International Classification of Functioning, Disability, and Health domains']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",25.0,0.116711,"After 6 weeks, percentage change in D-dimer was lower in the ERTE group, but not significantly after the Bonferroni correction.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Piraux', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': ''}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': ''}, {'ForeName': 'Jean-Cyr', 'Initials': 'JC', 'LastName': 'Yombi', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Caty', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000005'] 843,30614004,Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial.,"BACKGROUND Retinopathy of prematurity (ROP) is a disorder of the retina of low-birth-weight preterm infants that potentially leads to blindness. Docosahexaenoic acid (DHA), is protective in experimental models, but its administration as part of parenteral nutrition has shown inconsistent results. We test the effect of enteral DHA to prevent ROP and/or severity and to reduce hospital stay. METHODS This was a double-blind parallel clinical trial. Preterm infants (n = 110; 55 per group) with birth weight <1500 g but ≥1000 g were recruited in a neonatal intensive care unit. Infants were randomized to receive 75 mg of DHA/kg/d (DHA group) or high oleic sunflower oil (control group) for 14 days by enteral feeding. The effect of DHA was evaluated on any stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay. Groups were compared with relative risk (RR) and 95% confidence interval (CI), Fisher's exact test, Student's t-test, or Mann-Whitney U-test, as appropriate. Logistic regression was applied to adjust for confounders. RESULTS There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33). However, patients who received DHA showed lower risk for stage 3 ROP (RR for DHA = 0.66; 95% CI, 0.44-0.99; P = 0.03). After adjusting for confounders, this decreased risk remained significant (adjusted odds ratio = 0.10; 95% CI, 0.011-0.886; P = 0.04). Hospital stay was similar between groups. CONCLUSION Enteral DHA may reduce the incidence of stage 3 ROP.",2019,"There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33).","['Preterm infants (n = 110; 55 per group) with birth weight', 'but ≥1000 g were recruited in a neonatal intensive care unit', 'and Retinopathy of Prematurity']","['enteral DHA', 'DHA', 'Enteral Docosahexaenoic Acid', 'DHA/kg/d (DHA group) or high oleic sunflower oil (control group', 'Docosahexaenoic acid (DHA']","['lower risk for stage 3 ROP', 'stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay', 'ROP risk', 'Hospital stay']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.437828,"There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33).","[{'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Bernabe-García', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Villegas-Silva', 'Affiliation': 'Neonatología, Hospital Infantil de México Federico Gómez, México City, México.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Villavicencio-Torres', 'Affiliation': 'Oftalmología Pediátrica, General Hospital, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Rodríguez-Cruz', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maldonado-Hernández', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Macías-Loaiza', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Mardia', 'Initials': 'M', 'LastName': 'López-Alarcón', 'Affiliation': 'Unidad de Investigación Médica en Nutrición, Hospital de Pediatría, Centro Médico Nacional, Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Inda-Icaza', 'Affiliation': 'Nutrición, Universidad Anáhuac México, Campus Norte, Huixquilucan, Estado de México, México.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Cruz-Reynoso', 'Affiliation': 'División de Pediatría, Hospital de Gineco-Obstetricia No.3, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1497'] 844,30665608,"A randomized controlled trial for aggression and substance use involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care.","Physical aggression (towards partners or non-partners) is common among patients in treatment for substance use disorders (SUDs), including among Veteran samples; however, few treatment programs provide adjunct intervention approaches targeting reduction or prevention of aggression. The primary objectives of this comparative efficacy study were to examine the impact of adjunct aggression interventions delivered during treatment on aggression and substance use outcomes, including: a) an acute treatment phase 6-session integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT) for aggression and substance use prevention, b) MI-CBT plus a 12-week telephone-based Continuing Care (MI-CBT + CC) intervention, and c) an acute phase single session control condition [including some discussion of violence prevention and local violence prevention resources (Enhanced Treatment as Usual (E-TAU))]. Participants (N = 180; 165 males and 15 females) were Veterans with SUD problems and past-year severe aggression who were randomized to one of three conditions: MI-CBT, MI-CBT + CC, or E-TAU. Primary 12-month outcomes included physical aggression and injury to partners, non-partners, and total aggression (collapsing across partner and non-partner relationships). Substance use outcomes included heavy drinking, marijuana use, cocaine use, and overall illicit substance use. Due to low representation in the sample (n = 4 women in each group at follow-up), women were excluded from primary analyses. According to unadjusted analyses of male participants, all groups showed similar significant declines in aggression over time, with the MI-CBT and MI-CBT + CC groups showing significant reductions in more substance use outcomes (heavy drinking, cocaine use, overall illicit drug use) than the E-TAU group. The only significant group x time interaction was for partner physical aggression by men (those in the MI-CBT + CC group showed a significantly greater decrease from baseline to follow-up). Also, neither the MI-CBT nor MI-CBT + CC groups reported any injuring of partners during the follow-up. For heavy drinking, cocaine, marijuana and overall illicit drug use, there were significant reductions over time, but no group by time interaction effects. The findings illustrate significant reductions in aggression and substance use over time for those involved in VA SUD treatment, and a potential modest benefit of additional integrated treatment approaches (MI-CBT, MI-CBT + CC) on reducing aggression. Future studies should examine dissemination efforts in the VA, cost-effectiveness, and moderators of outcome.",2019,"For heavy drinking, cocaine, marijuana and overall illicit drug use, there were significant reductions over time, but no group by time interaction effects.","['Veterans', 'Participants (N\u202f=\u202f180; 165 males and 15 females) were Veterans with SUD problems and past-year severe aggression who were randomized to one of three conditions']","['acute treatment phase 6-session integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT) for aggression and substance use prevention, b) MI-CBT plus a 12-week telephone-based Continuing Care (MI-CBT\u202f+\u202fCC) intervention, and c) an acute phase single session control condition [including some discussion of violence prevention and local violence prevention resources (Enhanced Treatment as Usual (E-TAU', 'Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care', 'adjunct aggression interventions', 'MI-CBT, MI-CBT\u202f+\u202fCC, or E-TAU']","['heavy drinking, marijuana use, cocaine use, and overall illicit substance use', 'substance use outcomes (heavy drinking, cocaine use, overall illicit drug use', 'physical aggression and injury to partners, non-partners, and total aggression (collapsing across partner and non-partner relationships', 'aggression', 'Physical aggression', 'partner physical aggression', 'aggression and substance use over time']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C4316909', 'cui_str': 'Marijuana Use'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0264855,"For heavy drinking, cocaine, marijuana and overall illicit drug use, there were significant reductions over time, but no group by time interaction effects.","[{'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Chermack', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Mental Health Service, 2215 Fuller Road, Ann Arbor, MI 48105, United States of America; Veterans Affairs Ann Arbor Healthcare System, Center for Clinical Management Research, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America; University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America; University of Michigan, Injury Prevention Center, 2800 Plymouth Road, Building 10, Ann Arbor, MI 48109, United States of America. Electronic address: erinbona@med.umich.edu.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Goldstick', 'Affiliation': 'University of Michigan, Injury Prevention Center, 2800 Plymouth Road, Building 10, Ann Arbor, MI 48109, United States of America; University of Michigan, Department of Emergency Medicine, 2800 Plymouth Road, Building 10, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Winters', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Mental Health Service, 2215 Fuller Road, Ann Arbor, MI 48105, United States of America; University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Frederic C', 'Initials': 'FC', 'LastName': 'Blow', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Center for Clinical Management Research, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America; University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Friday', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Center for Clinical Management Research, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ilgen', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Center for Clinical Management Research, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America; University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Mental Health Service, 2215 Fuller Road, Ann Arbor, MI 48105, United States of America; Emory University, Department of Psychiatry and Behavioral Sciences, 12 Executive Park Drive, 3rd Floor, Atlanta, GA 30329, United States of America; Veterans Affairs Atlanta Healthcare System, 1670 Clairmont Road, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Perron', 'Affiliation': 'University of Michigan, School of Social Work, 1080 South University Ave., Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Quyen M', 'Initials': 'QM', 'LastName': 'Ngo', 'Affiliation': 'University of Michigan, Injury Prevention Center, 2800 Plymouth Road, Building 10, Ann Arbor, MI 48109, United States of America; University of Michigan, Department of Emergency Medicine, 2800 Plymouth Road, Building 10, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'University of Michigan, Department of Psychiatry, Addiction Center, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, United States of America; University of Michigan, Injury Prevention Center, 2800 Plymouth Road, Building 10, Ann Arbor, MI 48109, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.01.001'] 845,31898191,The efficacy of mind-body (Baduanjin) exercise on self-reported sleep quality and quality of life in elderly subjects with sleep disturbances: a randomized controlled trial.,"OBJECTIVES To examine the efficacy of a 24-week Baduanjin exercise program on self-reported sleep quality and quality of life in community-dwelling elderly subjects with sleep disturbances. METHODS Community-dwelling elderly men and women meeting criteria for sleep disturbances (i.e., Pittsburgh Sleep Quality of Index (PSQI) score ≥ 5) were recruited and randomized to a Baduanjin exercise intervention group or a control group. Participants in the intervention group completed five 45-min exercise sessions per week for 24 weeks, while those in control group were instructed to maintain their usual lifestyle behaviors. RESULTS A total of 139 participants were enrolled and randomized. Sixty-two of 67 participants in the intervention group (response rate of 92.5%) and 57 of 72 participants (response rate of 79.6%) in the control group completed intervention and follow-up. The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007). Intervention group participants had higher response rates at both week 12 (23.9% vs. 9.7%, p = 0.025) and week 24 (40.3% vs. 15.3%, p = 0.001) when compared with the control group. There was a trend that the intervention group had increased quality of life (The Short Form Health Survey [SF-36] endpoint=tobaseline change 6.3 ± 10.9 vs. 2.2 ± 10.9, time × group interaction p = 0.06) when compared with the control group. CONCLUSIONS Baduanjin exercise is an effective and feasible approach to improve self-reported sleep quality but less likely the quality of life in community-dwelling elderly men and women with sleep disturbances. TRIAL REGISTRATION Effect of Baduanjin Exercise on the Elderly's Sleep; http://www.chictr.org.cn/listbycreater.aspx; ChiCTR1800014706, registered 1 January 2018.",2020,"The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007).","['community-dwelling elderly subjects with sleep disturbances', 'elderly subjects with sleep disturbances', '139 participants were enrolled and randomized', 'Community-dwelling elderly men and women meeting criteria for sleep disturbances', ""Elderly's Sleep"", 'community-dwelling elderly men and women with sleep disturbances']","['45-min exercise sessions', 'Baduanjin exercise', 'Baduanjin exercise intervention group or a control group', 'Baduanjin exercise program', 'Baduanjin Exercise', 'mind-body (Baduanjin) exercise']","['response rates', 'quality of life', 'overall sleep quality', 'sleep quality and quality of life']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",139.0,0.0584591,"The intervention group reported significant improvements in overall sleep quality after 24 weeks compared with those randomized to control (PSQI endpoint-to-baseline change = - 2.6 ± 4.0 vs. - 0.5 ± 4.2, time × group interaction p = 0.007).","[{'ForeName': 'Beifang', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China. songweile@163.com.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Er', 'Affiliation': 'The National Center for Chronic and Non-communicable Disease Control and Prevention, The Chinese Center for Disease Control and Prevention, Xicheng District, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Chengmin', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, Shenzhen Nanshan Center for Chronic Disease Control, Nanshan, Shenzhen, China.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Mcintyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, Canada.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01999-w'] 846,30230026,Four-year outcome of randomly assigned lifestyle treatments in primary care of children with obesity.,"AIM To assess the four-year outcome in children with obesity randomised to one of two 12-month lifestyle treatment programmes in primary care. METHODS At baseline, 64 children with obesity aged 8.0-13.0 years were randomised to a treatment programme managed either by a nurse, dietician and physiotherapist (n = 32) or by a nurse and dietician (n = 32). RESULTS From baseline to follow-up, the mean body mass standard deviation score (BMISDS) had decreased by -0.50 [standard deviation (SD) 0.73], p = 0.002, in the nurse, dietician and physiotherapist group (n = 27), by -0.26 (SD 0.73), p = 0.057 in the other group (n = 29); adjusted mean difference was -0.22, 95% confidence interval -0.59; 0.16, p = 0.25. Changes in weight categories did not differ between the groups: both had a change from obesity to normal weight in 1 and to overweight in 6; in the physiotherapist group 1 case of severe obesity changed to obesity. The combined treatment groups (n = 56) had a mean reduction in BMISDS of -0.37 (SD 0.73) and an improved distribution in weight categories, p = 0.015. CONCLUSION After four years, there was no difference in outcome between the treatment options. In the treatment groups combined the number of children with obesity and their adiposity measures were significantly lower.",2019,"After four years, there was no difference in outcome between the treatment options.","['64 children with obesity aged 8.0-13.0\xa0years', 'children with obesity', 'children with obesity randomised to one of two 12-month lifestyle treatment programmes in primary care']","['treatment programme managed either by a nurse, dietician and physiotherapist (n\xa0=\xa032) or by a nurse and dietician']","['weight categories', 'mean reduction in BMISDS', 'number of children with obesity and their adiposity measures', 'mean body mass standard deviation score (BMISDS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",64.0,0.0565018,"After four years, there was no difference in outcome between the treatment options.","[{'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Forsell', 'Affiliation': 'Paediatric Department, Alingsås Hospital, Västra Götaland Region, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gronowitz', 'Affiliation': 'Department of Paediatrics, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Larsson', 'Affiliation': 'Paediatric Department, Alingsås Hospital, Västra Götaland Region, Sweden.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Kjellberg', 'Affiliation': 'Paediatric Department, Skövde Hospital, Västra Götaland Region, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Friberg', 'Affiliation': 'Department of Physiology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Mårild', 'Affiliation': 'Department of Paediatrics, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.14583'] 847,31808151,Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index.,"Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4 mg.kg -1 or saline. In cases of incomplete reversal of neuromuscular blockade after 5 min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p < 0.01) with an increase of ≥ 20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.",2019,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","['Fifty-one patients completed the study', 'patients maintained under general anaesthesia following sugammadex administration', 'Patients, scheduled to receive general anaesthesia with neuromuscular blockade']","['sugammadex', 'sugammadex 4\xa0mg.kg -1 or saline', 'anaesthetic agents', 'Sugammadex', 'Saline']","['bispectral index values', 'clinical signs of awakening', 'Median (IQR [range', 'bispectral index values and signs of awakening', 'bispectral index values, clinical signs of awakening or degree of neuromuscular blockade', 'Bispectral index and train-of-four monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C1301770', 'cui_str': 'Train-of-Four Monitoring'}]",51.0,0.555859,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chazot', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': 'Department of Electrical and Computer Engineering, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}]",Anaesthesia,['10.1111/anae.14897'] 848,31843638,Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents.,"Latinx adolescents are at higher risk for chronic diseases relative to adolescents of other ethnic groups, in part because of their lack of adherence to diet recommendations and their higher rates of substance use. Given the proximal influence of family factors during the developmental stage of adolescence, parenting interventions may be an effective way to promote healthy nutrition and substance use prevention simultaneously. This article describes the design and theoretical rationale of a study assessing the effects of Families Preparing the New Generation Plus (FPNG Plus), a 10-week culturally-tailored nutrition and substance use prevention parenting program, on diet and substance use outcomes among Latinx middle school students (6th-8th grade). The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level. Adolescents and parents will complete surveys pre- and post-intervention, and 16-weeks after program participation, regarding diet behaviors, substance use, and parenting practices. A random subsample of 126 dyads (42 from each program), will participate in additional data collection to assess the home food environment, detailed dietary intake (via two 24-h recalls), and provide biomarkers of cardiometabolic risk (blood pressure, total cholesterol and HbA1c). If successful, this study will provide evidence contributing to helping Latinx parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent concurrent substance use and diet-related chronic diseases.",2020,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","['Latinx adolescents', 'Latinx middle school students (6th-8th grade', 'A random subsample of 126 dyads (42 from each program', '1494 parent-child dyads from 18 schools, randomized at the school level']","['parenting intervention', 'FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success']","['cardiometabolic risk (blood pressure, total cholesterol and HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0150358', 'cui_str': 'Substance use prevention (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0700132', 'cui_str': 'Academic Success'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",126.0,0.0486669,"The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America; Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America. Electronic address: Sonia.Vega.Lopez@asu.edu.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Anaid', 'Initials': 'A', 'LastName': 'Gonzalvez', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Vega-Luna', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Perilla', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Southwest Interdisciplinary Research Center, School of Social Work, Watts College of Public Service and Community Solutions, Arizona State University, 201 North Central Avenue, 33rd Floor, Phoenix, AZ 85004, United States of America; College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Delgado', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rosario', 'Affiliation': 'American Dream Academy, Arizona State University, 542 E. Monroe Street, Suite D-100, Phoenix, AZ 85004, United States of America.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University, 500 North 3rd Street, Phoenix, AZ 85004, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105914'] 849,31198990,An automated motivational interview promotes donation intention and self-efficacy among experienced whole blood donors.,"BACKGROUND Interventions intended to motivate donors to return can be costly and time consuming. The current study examined the effect of a Web-based automated interview, informed by motivational interviewing and self-determination theory, on donor intention, motivation, and behavior in a sample of highly experienced donors. STUDY DESIGN AND METHODS Approximately 1 week after donating, 1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female) participated in a study in which they were randomly assigned to either a donor motivational interview (n = 544) or knowledge interview (n = 633). Measures of donor motivation and psychological need support were obtained before the interviews, and again at postinterview assessments conducted approximately 2 days later and 7 weeks later. Blood center records were used to assess repeat donation attempts for 1 year after the interviews. RESULTS Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up. Among women only, the motivational interview was associated with greater competence and relatedness increases at both follow-up assessments. CONCLUSION An automated motivational interview appears to be a feasible way to promote donation intention and self-efficacy. Although the observed effects were small among highly experienced donors, we are currently assessing the potential effect of this intervention among less experienced donors.",2019,"Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up.","['1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female']",['donor motivational interview (n = 544) or knowledge interview'],['donation intention and self-efficacy'],"[{'cui': 'C0375876', 'cui_str': 'Whole blood donor (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0142229,"Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up.","[{'ForeName': 'Irina E', 'Initials': 'IE', 'LastName': 'Livitz', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Fox', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Ankawi', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'P Maxwell', 'Initials': 'PM', 'LastName': 'Slepian', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Kessler', 'Affiliation': 'New York Blood Center, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rebosa', 'Affiliation': 'New York Blood Center, New York, New York.'}, {'ForeName': 'Beth H', 'Initials': 'BH', 'LastName': 'Shaz', 'Affiliation': 'New York Blood Center, New York, New York.'}]",Transfusion,['10.1111/trf.15402'] 850,31912780,Glyceryl trinitrate to reduce the need for manual removal of retained placenta following vaginal delivery: the GOT-IT RCT.,"BACKGROUND Retained placenta is associated with postpartum haemorrhage and can lead to significant maternal morbidity if untreated. The only effective treatment is the surgical procedure of manual removal of placenta, which is costly, requires skilled staff, requires an operative environment and is unpleasant for women. Small studies suggest that glyceryl trinitrate may be an effective medical alternative. OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of sublingual glyceryl trinitrate spray compared with placebo in reducing the need for manual removal of placenta in women with retained placenta after vaginal delivery following the failure of current management. DESIGN A group-sequential randomised double-blind placebo-controlled trial with a cost-effectiveness analysis. SETTING There were 29 obstetric units in the UK involved in the study. PARTICIPANTS There were 1107 women (glyceryl trinitrate group, n  = 543; placebo group, n  = 564) randomised between October 2014 and July 2017. INTERVENTIONS Glyceryl trinitrate spray was administered to 541 women in the intervention group, and a placebo was administered to 563 women in the control group. MAIN OUTCOME MEASURES Four primary outcomes were defined: (1) clinical - the need for manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness of both treatments using the UK NHS perspective. Secondary clinical outcomes included a > 15% decrease in haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics. RESULTS No difference was observed between the glyceryl trinitrate group and the control group for the placenta remaining undelivered within 15 minutes of study treatment (93.3% vs. 92%; odds ratio 1.01, 95% confidence interval 0.98 to 1.04; p  = 0.393). There was no difference in blood loss of > 1000 ml between the glyceryl trinitrate group and the control group (22.2% vs. 15.5%; odds ratio 1.14, 95% confidence interval 0.88 to 1.48; p  = 0.314). Palpitations were more common in the glyceryl trinitrate group than in the control group after taking the study drug (9.8% vs. 4.0%; odds ratio 2.60, 95% confidence interval 1.40 to 4.84; p  = 0.003). There was no difference in any other measures of patient satisfaction between the groups. There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79). Secondary outcomes revealed that a fall in systolic or diastolic blood pressure, or an increase in heart rate, was more common in the glyceryl trinitrate group than in the control group (odds ratio 4.9, 95% confidence interval 3.7 to 6.4; p  < 0.001). The need for a blood transfusion was also more common in the glyceryl trinitrate group than in the control group (odds ratio 1.53, 95% confidence interval 1.04 to 2.25; p  = 0.033). CONCLUSIONS Glyceryl trinitrate spray did not increase the delivery of retained placenta within 15 minutes of administration when compared with the placebo, and was not cost-effective for medical management of retained placenta. More participants reported palpitations and required a blood transfusion in the glyceryl trinitrate group. Further research into alternative methods of medical management of retained placenta is required. TRIAL REGISTRATION Current Controlled Trials ISRCTN88609453. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 70. See the NIHR Journals Library website for further project information.",2019,"There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79).","['563 women in the control group', '1107 women (glyceryl trinitrate group, n \u2009=\u2009543; placebo group, n \u2009=\u2009564) randomised between October 2014 and July 2017', '29 obstetric units in the UK involved in the study', 'women with retained placenta after vaginal delivery following the failure of current management']","['glyceryl trinitrate', 'sublingual glyceryl trinitrate spray', 'placebo', 'Glyceryl trinitrate spray', 'Glyceryl trinitrate']","['delivery of retained placenta', 'costs to the health service', 'blood transfusion', 'manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness', 'Palpitations', 'blood loss', 'haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics', 'fall in systolic or diastolic blood pressure, or an increase in heart rate', 'patient satisfaction', 'manual removal of placenta']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0195755', 'cui_str': 'Manual removal of retained placenta (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0404381', 'cui_str': 'Placental delivery procedure (procedure)'}, {'cui': 'C0475307', 'cui_str': 'Theatre (environment)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0574078', 'cui_str': 'Maternal pyrexia'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0241597', 'cui_str': 'Uterine relaxation'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",1107.0,0.501515,"There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79).","[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Denison', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Carruthers', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sheonagh', 'Initials': 'S', 'LastName': 'Brook-Smith', 'Affiliation': ""Simpson's Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Clarkson', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Peace', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's, Nicholas House, London, UK.""}, {'ForeName': 'Gin Nie', 'Initials': 'GN', 'LastName': 'Chua', 'Affiliation': 'Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hallowell', 'Affiliation': 'Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': ""Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit/Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23700'] 851,31547694,Problematic presentation and use of efficacy measures in current trials of CGRP monoclonal antibodies for episodic migraine prevention: A mini-review.,"BACKGROUND In trials of monoclonal antibodies against calcitonin gene-related peptide or its receptor for prevention of episodic migraine, we observed two problematic aspects: a) The graphic presentations; b) the methods of calculating ""response rates"" (≥50% decrease of monthly migraine days from baseline). OBSERVATIONS Decrease in monthly migraine days is presented, over time, in figures on a downward (negative) scale from zero at baseline, with the ordinate stopped just beyond the maximum effect of the active drugs. In one trial, decreases in monthly migraine days were -1.8 after placebo, -3.2 after erenumab 70 mg and -3.7 after erenumab 140 mg, with the ordinate stopped at -4.5. The reader can perceive only a relative 2-fold benefit of erenumab versus placebo. If, however, treatment periods are compared with baseline in bar charts, MMDs persisting after treatment in the same trial can be illustrated as follows, creating a different perception: 78% for placebo, 61% for erenumab 70 mg, and 55% for erenumab 140 mg. In the nine trials, ""response rates"" defined as above were calculated in five different ways, taking different numbers of treatment months into account in comparisons with the one-month baseline. This makes comparisons impossible. SUGGESTIONS FOR IMPROVEMENTS Mean monthly migraine days before and after treatment should be presented in a bar chart. Such figures, presenting persisting MMDs, are more clinically relevant and less misleading than decreases from baseline. The definition and methods of calculating and presenting ""50% response rates"" should be standardized by the Drug Trial Committee of the International Headache Society.",2020,"In one trial, decreases in monthly migraine days were -1.8 after placebo, -3.2 after erenumab 70 mg and -3.7 after erenumab 140 mg, with the ordinate stopped at -4.5.",[],"['placebo', 'CGRP monoclonal antibodies']",['monthly migraine days'],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.221515,"In one trial, decreases in monthly migraine days were -1.8 after placebo, -3.2 after erenumab 70 mg and -3.7 after erenumab 140 mg, with the ordinate stopped at -4.5.","[{'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Tfelt-Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Medical Faculty of the University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Steiner', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419877663'] 852,31574564,Randomized controlled trial comparing hydroxychloroquine with pioglitazone as third-line agents in type 2 diabetic patients failing metformin plus a sulfonylurea: A pilot study.,,2020,,['Type 2 Diabetic Patients Failing Metformin Plus a Sulfonylurea'],['Hydroxychloroquine with Pioglitazone'],[],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]",[],,0.0783592,,"[{'ForeName': 'Stanley H', 'Initials': 'SH', 'LastName': 'Hsia', 'Affiliation': 'Division of Endocrinology, Metabolism & Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Duran', 'Affiliation': 'Division of Endocrinology, Metabolism & Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology, Metabolism & Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California.'}, {'ForeName': 'Mayer B', 'Initials': 'MB', 'LastName': 'Davidson', 'Affiliation': 'Division of Endocrinology, Metabolism & Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California.'}]",Journal of diabetes,['10.1111/1753-0407.12989'] 853,31843833,Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial.,"INTRODUCTION Despite the high number of frozen embryo transfer (FET) cycles being conducted (190 000 cycles/year) in Europe, the timing of blastocyst transfer and the use of luteal phase progesterone support in modified natural cycle FET (mNC-FET) in assisted reproductive technologies are controversial. In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity. However, the optimal day of blastocyst transfer following ovulation trigger is not determined. In addition, the value of luteal phase support to maintain the endometrium remains uncertain. Thus, there is a need to identify the optimal timing of blastocyst warming and transfer and the effect of luteal phase support in a randomised controlled trial design. The aim of this randomised controlled trial is to investigate if progesterone supplementation from the early luteal phase until gestational age 8 weeks is superior to no progesterone supplementation and to assess if blastocyst warming and transfer 6 days after ovulation trigger is superior to 7 days after ovulation trigger in mNC-FET with live birth rates as the primary outcome. METHODS AND ANALYSIS Multicentre, randomised, controlled, single-blinded trial including 604 normo-ovulatory women aged 18-41 years undergoing mNC-FET with a high-quality blastocyst originating from their first to third in vitro fertilisation/intracytoplasmic sperm injection cycle. Participants are randomised (1:1:1:1) to either luteal phase progesterone or no luteal phase progesterone and to blastocyst warming and transfer on day 6 or 7 after human chorionic gonadotropin trigger. Only single blastocyst transfers will be performed. ETHICS AND DISSEMINATION The study is approved by the Danish Committee on Health Research Ethics (H-18025839), the Danish Medicines Agency (2018061319) and the Danish Data Protection Agency (VD-2018-381). The results of the study will be publicly disseminated. TRIAL REGISTRATION NUMBER The study is registered in EudraCT (2018-002207-34) and on ClinicalTrials.gov (NCT03795220); Pre-results.",2019,"In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity.",['604 normo-ovulatory women aged 18-41 years undergoing mNC-FET with a high-quality blastocyst originating from their first to third in vitro fertilisation/intracytoplasmic sperm injection cycle'],"['progesterone supplementation', 'modified natural cycle frozen-thawed embryo transfers (mNC-FET', 'luteal phase progesterone or no luteal phase progesterone and to blastocyst warming and transfer on day 6 or 7 after human chorionic gonadotropin trigger']",[],"[{'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0643582', 'cui_str': 'FETS'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]",[],,0.109595,"In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity.","[{'ForeName': 'Marte', 'Initials': 'M', 'LastName': 'Saupstad', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark marte.saupstad@regionh.dk.'}, {'ForeName': 'Nina La Cour', 'Initials': 'NC', 'LastName': 'Freiesleben', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sven Olaf', 'Initials': 'SO', 'LastName': 'Skouby', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars Franch', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Ulla Breth', 'Initials': 'UB', 'LastName': 'Knudsen', 'Affiliation': 'Kvindeafdelingen, Aarhus University Hospital, Horsens Hospital and the Institute of Clinical Medicine, Horsens, Denmark.'}, {'ForeName': 'Kathrine Birch', 'Initials': 'KB', 'LastName': 'Petersen', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Zealands University Hospital, Køge Hospital, Køge, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Husth', 'Affiliation': 'Fertilitetsenheden og Center for Præimplantationsdiagnostik, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Egeberg', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Morten Rønn', 'Initials': 'MR', 'LastName': 'Petersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ziebe', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders Nyboe', 'Initials': 'AN', 'LastName': 'Andersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-031811'] 854,31901082,The effects of extra virgin olive oil and canola oil on inflammatory markers and gastrointestinal symptoms in patients with ulcerative colitis.,"BACKGROUND/OBJECTIVES Ulcerative colitis (UC) is an immune-mediated disease that causes inflammation in the gastrointestinal tract. Diet has an important role in the treatment of UC. This study aimed to compare the effects of extra virgin olive oil (EVOO), as a functional food, with canola oil in the treatment of UC. SUBJECTS/METHODS Forty patients were participating in this crossover clinical trial. Thirty two patients completed two intervention rounds. Blood samples were taken before and after 20 days intervention. Disease activity score and gastrointestinal symptoms were evaluated using the Mayo score and gastrointestinal symptom rating scale (GSRS) respectively. RESULTS Erythrocyte sedimentation rate (p = 0.03) and high-sensitivity C-reactive protein (p < 0.001) were decreased significantly after EVOO consumption. Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05). CONCLUSIONS Intake of EVOO decreased the inflammatory markers and improved gastrointestinal symptoms in UC patients. It seems this functional food can be beneficial in the treatment of UC as a complementary medicine.",2020,"Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05). ","['Ulcerative colitis (UC', 'UC patients', 'Forty patients were participating in this crossover clinical trial', 'patients with ulcerative colitis']","['extra virgin olive oil and canola oil', 'extra virgin olive oil (EVOO']","['Disease activity score and gastrointestinal symptoms', 'gastrointestinal symptoms', 'Mayo score and gastrointestinal symptom rating scale (GSRS) respectively', 'Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS', 'inflammatory markers and gastrointestinal symptoms', 'Erythrocyte sedimentation rate', 'high-sensitivity C-reactive protein']","[{'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool (finding)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",40.0,0.0271139,"Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05). ","[{'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Morvaridi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jafarirad', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. sjafarirad@gmail.com.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Cheraghian', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0549-z'] 855,31796486,Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial.,"OBJECTIVE To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis. DESIGN A multicentre randomised controlled trial (January 2008/October 2013). SETTING Eight paediatric diabetes centres in England, Wales and Northern Ireland. PARTICIPANTS 203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers. INTERVENTION Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care. MAIN OUTCOME MEASURES Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources. RESULTS 203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms. CONCLUSIONS There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes. TRIAL REGISTRATION NUMBER ISRCTN78114042.",2019,"There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm.","['203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers', 'children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2\u2009years postdiagnosis', '203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102', 'children newly diagnosed with type 1 diabetes', 'children with type 1 diabetes', 'Eight paediatric diabetes centres in England, Wales and Northern Ireland']",[],"['number of investigations', 'coping, anxiety, quality of life and use of NHS resources', 'child self-esteem', 'mean HbA1c levels', 'Mean HbA1c', 'glycosylated haemoglobin (HbA1c) concentration']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",203.0,0.280119,"There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Cardiff University, School of Medicine, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Townson', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK townson@cf.ac.uk.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Health Economics and Policy Research Unit, University of South Wales, Pontypridd, UK.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Longo', 'Affiliation': 'Marie Curie Palliative Care Research Centre, Cardiff University, School of Medicine, Cardiff, UK.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': ""Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harman', 'Affiliation': 'University of Liverpool, Institute of Translational Medicine, Liverpool, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tabitha', 'Initials': 'T', 'LastName': 'Randell', 'Affiliation': ""Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'School of Biosciences and Medicine, University of Surrey, Guildford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Trevelyan', 'Affiliation': ""Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Warner', 'Affiliation': 'Department of Child Health, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Lowes', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032317'] 856,31900121,"Radiation therapy before radical cystectomy combined with immunotherapy in locally advanced bladder cancer - study protocol of a prospective, single arm, multicenter phase II trial (RACE IT).","BACKGROUND Patients with locally advanced bladder cancer (cT3/4 cN0/N+ cM0) have a poor prognosis despite radical surgical therapy and perioperative chemotherapy. Preliminary data suggest that the combination of radiation and immunotherapy does not lead to excess toxicity and may have synergistic (abscopal) anti-tumor effects. We hypothesize that the combined preoperative application of the PD-1 checkpoint-inhibitor Nivolumab with concomitant radiation therapy of the bladder and pelvic region followed by radical cystectomy with standardized lymphadenectomy is safe and feasible and might improve outcome for patients with locally advanced bladder cancer. METHODS Study design: ""RACE IT"" (AUO AB 65/18) is an investigator initiated, prospective, multicenter, open, single arm phase II trial sponsored by Technical University Munich. Study drug and funding are provided by the company Bristol-Myers Squibb. Study treatment: Patients will receive Nivolumab 240 mg i.v. every 2 weeks for 4 cycles preoperatively with concomitant radiation therapy of bladder and pelvic region (max. 50.4 Gy). Radical cystectomy with standardized bilateral pelvic lymphadenectomy will be performed between week 11-15. Primary endpoint: Rate of patients with completed treatment consisting of radio-immunotherapy and radical cystectomy at the end of week 15. Secondary endpoints: Acute and late toxicity, therapy response and survival (1 year follow up). Main inclusion criteria: Patients with histologically confirmed, locally advanced bladder cancer (cT3/4, cN0/N+), who are ineligible for neoadjuvant, cisplatin-based chemotherapy or who refuse neoadjuvant chemotherapy. Main exclusion criteria: Patients with metastatic disease (lymph node metastasis outside pelvis or distant metastasis) or previous chemo-, immune- or radiation therapy. Planned sample size: 33 patients, interim analysis after 11 patients. DISCUSSION This trial aims to evaluate the safety and feasibility of the combined approach of preoperative PD-1 checkpoint-inhibitor therapy with concomitant radiation of bladder and pelvic region followed by radical cystectomy. The secondary objectives of therapy response and survival are thought to provide preliminary data for further clinical evaluation after successful completion of this trial. Recruitment has started in February 2019. TRIAL REGISTRATION Protocol Code RACE IT: AB 65/18; EudraCT: 2018-001823-38; Clinicaltrials.gov: NCT03529890; Date of registration: 27 June 2018.",2020,Primary endpoint: Rate of patients with completed treatment consisting of radio-immunotherapy and radical cystectomy at the end of week 15.,"['Main exclusion criteria: Patients with metastatic disease (lymph node metastasis outside pelvis or distant metastasis) or previous chemo-, immune- or radiation therapy', 'Planned sample size: 33 patients, interim analysis after 11 patients', 'Main inclusion criteria: Patients with histologically confirmed, locally advanced bladder cancer (cT3/4, cN0/N+), who are ineligible for neoadjuvant, cisplatin-based chemotherapy or who refuse neoadjuvant chemotherapy', 'Patients with locally advanced bladder cancer (cT3/4 cN0/N+ cM0', 'patients with locally advanced bladder cancer']","['preoperative PD-1 checkpoint-inhibitor therapy with concomitant radiation of bladder and pelvic region followed by radical cystectomy', 'Radiation therapy before radical cystectomy combined with immunotherapy', 'radio-immunotherapy and radical cystectomy', 'Protocol Code RACE', 'IT', 'radical cystectomy with standardized lymphadenectomy', 'Radical cystectomy with standardized bilateral pelvic lymphadenectomy', 'Nivolumab 240\u2009mg i.v']","['Acute and late toxicity, therapy response and survival (1\u2009year follow up']","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.133391,Primary endpoint: Rate of patients with completed treatment consisting of radio-immunotherapy and radical cystectomy at the end of week 15.,"[{'ForeName': 'Sebastian C', 'Initials': 'SC', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany. sebastian.schmid@tum.de.'}, {'ForeName': 'Florestan J', 'Initials': 'FJ', 'LastName': 'Koll', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiation Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Maisch', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sauter', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Beckert', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Seitz', 'Affiliation': 'Department of Urology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Kübler', 'Affiliation': 'Department of Urology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Flentje', 'Affiliation': 'Department of Radiation Oncology, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Chun', 'Affiliation': 'Department of Urology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Combs', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Kilian', 'Initials': 'K', 'LastName': 'Schiller', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Retz', 'Affiliation': 'Department of Urology, School of Medicine, Rechts der Isar Medical Center, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany.'}]",BMC cancer,['10.1186/s12885-019-6503-6'] 857,31202468,"Safety and efficacy of deferiprone for pantothenate kinase-associated neurodegeneration: a randomised, double-blind, controlled trial and an open-label extension study.","BACKGROUND Pantothenate kinase-associated neurodegeneration (PKAN) is a rare genetic disorder characterised by progressive generalised dystonia and brain iron accumulation. We assessed whether the iron chelator deferiprone can reduce brain iron and slow disease progression. METHODS We did an 18-month, randomised, double-blind, placebo-controlled trial (TIRCON2012V1), followed by a pre-planned 18-month, open-label extension study, in patients with PKAN in four hospitals in Germany, Italy, England, and the USA. Patients aged 4 years or older with a genetically confirmed diagnosis of PKAN, a total score of at least 3 points on the Barry-Albright Dystonia (BAD) scale, and no evidence of iron deficiency, neutropenia, or abnormal hepatic or renal function, were randomly allocated (2:1) to receive an oral solution of either deferiprone (30 mg/kg per day divided into two equal doses) or placebo for 18 months. Randomisation was done with a centralised computer random number generator and with stratification based on age group at onset of symptoms. Patients were allocated to groups by a randomisation team not masked for study intervention that was independent of the study. Patients, caregivers, and investigators were masked to treatment allocation. Co-primary endpoints were the change from baseline to month 18 in the total score on the BAD scale (which measures severity of dystonia in eight body regions) and the score at month 18 on the Patient Global Impression of Improvement (PGI-I) scale, which is a patient-reported interpretation of symptom improvement. Efficacy analyses were done on all patients who received at least one dose of the study drug and who provided a baseline and at least one post-baseline efficacy assessment. Safety analyses were done for all patients who received at least one dose of the study drug. Patients who completed the randomised trial were eligible to enrol in a single-arm, open-label extension study of another 18 months, in which all participants received deferiprone with the same regimen as the main study. The trial was registered on ClinicalTrials.gov, number NCT01741532, and EudraCT, number 2012-000845-11. FINDINGS Following a screening of 100 prospective patients, 88 were randomly assigned to the deferiprone group (n=58) or placebo group (n=30) between Dec 13, 2012, and April 21, 2015. Of these, 76 patients completed the study (49 in the deferiprone group and 27 in the placebo group). After 18 months, the BAD score worsened by a mean of 2·48 points (SE 0·63) in patients in the deferiprone group versus 3·99 points (0·82) for patients in the control group (difference -1·51 points, 95% CI -3·19 to 0·16, p=0·076). No subjective change was detected as assessed by the PGI-I scale: mean scores at month 18 were 4·6 points (SE 0·3) for patients in the deferiprone group versus 4·7 points (0·4) for those in the placebo group (p=0·728). In the extension study, patients continuing deferiprone retained a similar rate of disease progression as assessed by the BAD scale (1·9 points [0·5] in the first 18 months vs 1·4 points [0·4] in the second 18 months, p=0·268), whereas progression in patients switching from placebo to deferiprone seemed to slow (4·4 points [1·1] vs 1·4 points [0·9], p=0·021). Patients did not detect a change in their condition after the additional 18 months of treatment as assessed by the PGI-I scale, with mean scores of 4·1 points [0·2] in the deferiprone-deferiprone group and of 4·7 points [0·3] in the placebo-deferiprone group. Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group. No patient discontinued therapy because of anaemia, and three discontinued because of moderate neutropenia. There was one death in each group of the extension study and both were secondary to aspiration. Neither of these events was considered related to deferiprone use. INTERPRETATION Deferiprone was well tolerated, achieved target engagement (lowering of iron in the basal ganglia), and seemed to somewhat slow disease progression at 18 months, although not significantly, as assessed by the BAD scale. These findings were corroborated by the results of an additional 18 months of treatment in the extension study. The subjective PGI-I scale was largely unchanged during both study periods, indicating that might not be an adequate tool for assessment of disease progression in patients with PKAN. Our trial provides the first indication of a decrease in disease progression in patients with neurodegeneration with brain iron accumulation. The extensive information collected and long follow-up of patients in the trial will improve the definition of appropriate endpoints, increase the understanding of the natural history, and thus help to shape the design of future trials in this ultra-orphan disease. FUNDING European Commission, US Food and Drug Administration, and ApoPharma Inc.",2019,"Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group.","['patients with PKAN in four hospitals in Germany, Italy, England, and the USA', 'patients with PKAN', 'patients with neurodegeneration with brain iron accumulation', 'pantothenate kinase-associated neurodegeneration', 'Patients aged 4 years or older with a genetically confirmed diagnosis of PKAN, a total score of at least 3 points on the Barry-Albright Dystonia (BAD) scale, and no evidence of iron deficiency, neutropenia, or abnormal hepatic or renal function', 'group (n=30) between Dec 13, 2012, and April 21, 2015', '76 patients completed the study (49 in the deferiprone group and 27 in the placebo group']","['deferiprone', 'oral solution of either deferiprone', 'placebo', 'Deferiprone']","['subjective change', 'subjective PGI-I scale', 'disease progression', 'rate of disease progression', 'tolerated and adverse events', 'Patient Global Impression of Improvement (PGI-I) scale', 'BAD score', 'PGI-I scale: mean scores', 'BAD scale', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2931845', 'cui_str': 'Neurodegeneration with brain iron accumulation (NBIA)'}, {'cui': 'C0070043', 'cui_str': ""ATP-pantothenate 4'-phosphotransferase""}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0222045'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.274924,"Deferiprone was well tolerated and adverse events were similar between the treatment groups, except for anaemia, which was seen in 12 (21%) of 58 patients in the deferiprone group, but was not seen in any patients in the placebo group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klopstock', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany; German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany. Electronic address: thomas.klopstock@med.lmu.de.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Neumayr', 'Affiliation': ""Department of Hematology Oncology, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Karin', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Zorzi', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fradette', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kmieć', 'Affiliation': ""Department of Neurology and Epileptology, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Boriana', 'Initials': 'B', 'LastName': 'Büchner', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Steele', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, UK; Department of Clinical Neurosciences, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Chinnery', 'Affiliation': 'Department of Clinical Neurosciences, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Küpper', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Neuhofer', 'Affiliation': 'Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kálmán', 'Affiliation': 'Institute of Laboratory Medicine, Szentagothai Research Center, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Dušek', 'Affiliation': 'Charles University, Prague, Czech Republic.'}, {'ForeName': 'Zuhal', 'Initials': 'Z', 'LastName': 'Yapici', 'Affiliation': 'Department of Child Neurology, Istanbul Faculty of Medicine, Turkey.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cellular Medicine and Newcastle Magnetic Resonance Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Zibordi', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Nardo', 'Initials': 'N', 'LastName': 'Nardocci', 'Affiliation': 'Department of Pediatric Neuroscience, Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Aguilar', 'Affiliation': ""Pediatric Rehabilitation Department, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Hayflick', 'Affiliation': 'Department of Molecular & Medical Genetics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma Inc, Toronto, ON, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blamire', 'Affiliation': 'Institute of Cellular Medicine and Newcastle Magnetic Resonance Centre, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hogarth', 'Affiliation': 'Department of Molecular & Medical Genetics, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Vichinsky', 'Affiliation': ""Department of Hematology Oncology, UCSF Benioff Children's Hospital and Research Center Oakland, Oakland, CA, USA.""}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30142-5'] 858,31762105,Effect of increasing the delivery of smoking cessation care in alcohol and other drug treatment centres: a cluster-randomized controlled trial.,"AIM Aims were to test the effectiveness of an organizational change intervention integrating smoking cessation treatment into usual alcohol and other drug (AOD) treatment, compared with usual care, on (1) 7-day point prevalence abstinence (PPA) at 8 weeks follow-up; (2) prolonged abstinence; (3) cigarettes smoked per day; (4) number of quit attempts; and (5) offer and use of nicotine replacement therapy (NRT). All outcomes were assessed at 8 weeks and 6.5 months follow-up. DESIGN Cluster-randomized controlled trial, with AOD service as unit of randomization, conducted January 2015-March 2016. SETTING Thirty-two eligible services (provided face-to-face client sessions to ≥ 50 clients/year) in Australia were randomized to control (usual care; n = 15) or intervention (n = 17) groups by an independent blinded biostatistician. PARTICIPANTS Eligible participants (≥ 16 years, current smoker) completed surveys at the service at baseline (n = 896) and telephone follow-up surveys (conducted by blinded assessors) at 8 weeks (n = 471; 53%) and 6.5 months (n = 427; 48%). INTERVENTION Intervention services received an intervention to establish routine screening, assessment and delivery of smoking cessation care. MEASUREMENTS Primary outcome was biochemically verified 7-day PPA at 8-week follow-up. Secondary outcomes included verified and self-reported prolonged abstinence, self-reported 7-day PPA, cigarettes/day, quit attempts and offer and use of NRT. Intention-to-treat analyses were performed, assuming missing participants were not abstinent. FINDINGS At 8 weeks, the findings in verified 7-day PPA between groups [2.6 versus 1.8%, odds ratio (OR) = 1.72, 95% confidence interval (CI) = 0.5-5.7, P = 0.373] were inconclusive as to whether a difference was present. Significantly lower mean cigarettes/day were reported in the intervention group compared to the usual care group at 8 weeks [incidence rate ratio (IRR) = 0.88, 95% CI = 0.8-0.95, P = 0.001] but were similar at 6.5 months (IRR = 0.96, 95% CI = 0.9-1.02, P = 0.240) follow-up. At both follow-ups the intervention group reported higher rates of NRT use. CONCLUSIONS Integrating smoking cessation treatment into addiction services did not significantly improve short-term abstinence from smoking.",2020,Significantly lower mean cigarettes/day were reported in the intervention group compared to the usual care group at 8-weeks,"['Eligible participants (≥16yrs, current smoker) completed surveys at the service at baseline (n=896), and telephone follow-up surveys (conducted by blinded assessors) at 8-weeks', 'Thirty-two eligible services (provided face-to-face client sessions to ≥50 clients/year) in Australia were randomized to control (usual care; n=15) or intervention (n=17) groups by an independent blinded biostatistician']","['nicotine replacement therapy (NRT', 'Intervention services received an intervention to establish routine screening, assessment, and delivery of smoking cessation care', 'organizational change intervention integrating smoking cessation treatment into usual alcohol and other drug (AOD) treatment, compared with usual care, on 1) 7-day point prevalence abstinence (PPA']","['incidence rate ratio', 'rates of NRT use', 'verified and self-reported prolonged abstinence, self-reported 7-day PPA, cigarettes/day, quit attempts, and offer and use of NRT', '7-day PPA']","[{'cui': 'C3241966'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0086739', 'cui_str': 'Change, Organizational'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",32.0,0.135945,Significantly lower mean cigarettes/day were reported in the intervention group compared to the usual care group at 8-weeks,"[{'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Guillaumier', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Skelton', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shakeshaft', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walsberger', 'Affiliation': 'Tobacco Control Unit, Cancer Council NSW, Woolloomooloo, NSW, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stirling', 'Affiliation': 'Network of Alcohol and other Drugs Agencies, Woolloomooloo, NSW, Australia.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Fowlie', 'Affiliation': 'Alcohol, Tobacco and Other Drug Association ACT, Ainslie, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.14911'] 859,30451243,Comparative efficacy of continuous infusion of bupivacaine/fentanyl and ropivacaine/fentanyl for paediatric pain control after the Ravitch procedure and thoracotomy. A prospective randomized study.,"AIMS (1) To compare the efficacy of bupivacaine/fentanyl and ropivacaine/fentanyl for postoperative pain control (2). To identify the predictors of acute post-operative pain at rest, during deep breathing and coughing. METHODS The study was performed in patients aged 6-18 years after thoracic surgery. The subjects were randomized to the bupivacaine 0.125%/fentanyl 5.0 μg/mL (n=46) or ropivacaine 0.2%/fentanyl 5.0 μg/mL (n=48) group; analgesic mixtures were administered through epidural catheter. All the patients received paracetamol and non-steroidal anti-inflammatory drugs. The observation period after surgery lasted 72 h. Pain intensity was assessed at rest, during deep breathing and coughing and was based on the Numerical Rating Scale and the FLACC scale (range 0-10). If the pain was above 2/10, the analgesia was modified. RESULTS Median pain scores at rest (0.4 vs. 0.5), during deep breathing (0.3 vs. 0.3) and coughing (0.6 vs. 0.6) were comparable in BF and RF group. The intensity of pain at rest was associated with the number of drains inserted into the thorax (β=0.39), the number of pain intensity measurements (β=0.36) and the number of nursing interventions undertaken to relieve pain (β=0.16). Pain intensity at rest determined the intensity of pain during deep breathing (β=0.60), which in turn decided on the severity of pain during coughing (β=0.80). The intensity of pain was increased by age. CONCLUSIONS Thoracic epidural bupivacaine/fentanyl provided adequate pain relief and similar analgesia to ropivacaine/fentanyl. The effectiveness of analgesia depended on the number of pain measurements and interventions by nurses to relieve the pain. TRIAL REGISTRATION ClinicalTrials.gov; Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy; NCT03444636; https://clinicaltrials.gov/ct2/show/NCT03444636.",2019,"RESULTS Median pain scores at rest (0.4 vs. 0.5), during deep breathing (0.3 vs. 0.3) and coughing (0.6 vs. 0.6) were comparable in BF and RF group.","['paediatric pain control after the Ravitch procedure and thoracotomy', 'postoperative pain control (2', 'Children and Adolescents', 'patients aged 6-18 years after thoracic surgery']","['bupivacaine 0.125%/fentanyl', 'bupivacaine/fentanyl and ropivacaine/fentanyl', 'ropivacaine 0.2%/fentanyl 5.0 μg/mL (n=48) group; analgesic mixtures were administered through epidural catheter', 'ropivacaine/fentanyl', 'paracetamol and non-steroidal anti-inflammatory drugs', 'bupivacaine/fentanyl']","['intensity of pain', 'Pain intensity', 'Median pain scores', 'coughing', 'Numerical Rating Scale and the FLACC scale', 'number of pain intensity measurements', 'adequate pain relief']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter, device (physical object)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.0823481,"RESULTS Median pain scores at rest (0.4 vs. 0.5), during deep breathing (0.3 vs. 0.3) and coughing (0.6 vs. 0.6) were comparable in BF and RF group.","[{'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Tomaszek', 'Affiliation': 'Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Pediatric Division, Rabka-Zdroj, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Fenikowski', 'Affiliation': 'Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Pediatric Division, Rabka-Zdroj, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Gawron', 'Affiliation': 'Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Pediatric Division, Rabka-Zdroj, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Komotajtys', 'Affiliation': 'Department of Thoracic Surgery, Institute for Tuberculosis and Lung Diseases, Pediatric Division, Rabka-Zdroj, Poland.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2018.072'] 860,31603002,Intradialytic exercise with blood flow restriction is more effective than conventional exercise in improving walking endurance in hemodialysis patients: a randomized controlled trial.,"OBJECTIVE This study aims to compare the effect of intradialytic aerobic exercise with blood flow restriction, without blood flow restriction (conventional) and no exercise (control) on muscle strength and walking endurance among chronic kidney disease patients. DESIGN Open label and parallel group randomized controlled trial. SUBJECTS Adult patients with chronic kidney disease on hemodialysis. INTERVENTION A 12-week intradialytic training with or without blood flow restriction compared with a control group. MAIN MEASURES Strength and walking endurance were measured using thoracolumbar dynamometry and a 6-minute walk test, respectively, before and after training. RESULTS A total of 66 patients were randomized into three groups: blood flow restriction group ( n  = 22), conventional exercise group ( n  = 22) and control group ( n  = 22). There were seven dropouts, and 59 patients were included in the analysis. There was a significant increase in the 6-minute walking distance in the blood flow restriction group (from 412.7 (115.9) to 483.0 (131.0) m, P  = 0.007) in comparison with the conventional exercise group (from 426.79 (115.00) to 433.2 (120.42) m, not significant) and the control group (from 428.4 (108.1) to 417.3 (100.2) m, not significant). The change in the walking distance over time was significantly different among groups (intervention group/time, P  = 0.02). The simple effects test found a significant time effect only in the blood flow restriction group. There was no significant difference in strength change between the groups. CONCLUSION Among chronic kidney disease patients, intradialytic exercise of low/moderate intensity with blood flow restriction was more effective in improving walking endurance than conventional exercise or no exercise.",2020,"The change in the walking distance over time was significantly different among groups (intervention group/time, P  = 0.02).","['66 patients', 'chronic kidney disease patients', '59 patients were included in the analysis', 'hemodialysis patients', 'Adult patients with chronic kidney disease on hemodialysis']","['conventional exercise', 'intradialytic training with or without blood flow restriction compared with a control group', 'conventional exercise group', 'Intradialytic exercise with blood flow restriction', 'intradialytic aerobic exercise with blood flow restriction, without blood flow restriction (conventional) and no exercise (control', 'conventional exercise or no exercise', 'blood flow restriction group']","['6-minute walking distance', 'strength change', 'walking distance over time', 'Strength and walking endurance', 'muscle strength and walking endurance', 'walking endurance', 'thoracolumbar dynamometry and a 6-minute walk test']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",66.0,0.0194508,"The change in the walking distance over time was significantly different among groups (intervention group/time, P  = 0.02).","[{'ForeName': 'Rodrigo Kohn', 'Initials': 'RK', 'LastName': 'Cardoso', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Aline Machado', 'Initials': 'AM', 'LastName': 'Araujo', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Fabrício Boscolo', 'Initials': 'FB', 'LastName': 'Del Vechio', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Bohlke', 'Affiliation': 'Dialysis and Renal Transplantation Unit, São Francisco de Paula University Hospital, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Franklin Correa', 'Initials': 'FC', 'LastName': 'Barcellos', 'Affiliation': 'Dialysis and Renal Transplantation Unit, São Francisco de Paula University Hospital, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Oses', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Matheus Pintanel', 'Initials': 'MP', 'LastName': 'de Freitas', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Airton José', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215519880235'] 861,31558478,Comprehensive Transcriptomic Profiling Identifies Breast Cancer Patients Who May Be Spared Adjuvant Systemic Therapy.,"PURPOSE There is currently no molecular signature in clinical use for adjuvant endocrine therapy omission in breast cancer. Given the unique trial design of SweBCG91-RT, where adjuvant endocrine and chemotherapy were largely unadministered, we sought to evaluate the potential of transcriptomic profiling for identifying patients who may be spared adjuvant endocrine therapy. EXPERIMENTAL DESIGN We performed a whole-transcriptome analysis of SweBCG91-RT, a randomized phase III trial of ± radiotherapy after breast-conserving surgery for node-negative stage I-IIA breast cancer. Ninety-two percent of patients were untreated by both adjuvant endocrine therapy and chemotherapy. We calculated 15 transcriptomic signatures from the literature and combined them into an average genomic risk, which was further used to derive a novel 141-gene signature (MET141). All signatures were then independently examined in SweBCG91-RT and in the publicly available METABRIC cohort. RESULTS In SweBCG91-RT, 454 patients were node-negative, postmenopausal, and systemically untreated with ER-positive, HER2-negative cancers, which constitutes a low-risk subgroup and potential candidates for therapy omission. Most transcriptomic signatures were highly prognostic for distant metastasis, but considerable discordance was observed on the individual patient level. Within the MET141 low-risk subgroup (lowest 25th percentile of scores), 95% of patients were free of metastasis at 15 years, even in the absence of adjuvant endocrine therapy. In a clinically low-risk subgroup of the METABRIC cohort not treated with systemic therapy, no breast cancer death occurred among the MET141 low-risk patients. CONCLUSIONS Transcriptomic profiling identifies patients with an excellent outcome without any systemic adjuvant therapy in clinically low-risk patients of the SweBCG91-RT and METABRIC cohorts.",2020,Transcriptomic profiling identifies patients with an excellent outcome without any systemic adjuvant therapy in clinically low-risk patients of the SweBCG91-RT and METABRIC cohorts.,"['patients who may be spared adjuvant endocrine therapy', 'breast cancer patients who may be spared adjuvant systemic therapy', '454 patients were node-negative, post-menopausal and systemically untreated with ER-positive, HER2-negative cancers, which constitutes a low-risk subgroup and potential candidates for therapy omission']","['SweBCG91-RT', 'adjuvant endocrine therapy and chemotherapy', 'radiotherapy']",['breast cancer death'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",454.0,0.0284549,Transcriptomic profiling identifies patients with an excellent outcome without any systemic adjuvant therapy in clinically low-risk patients of the SweBCG91-RT and METABRIC cohorts.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden. Martin.Sjostrom@med.lu.se.'}, {'ForeName': 'S Laura', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'PFS Genomics, Vancouver, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fishbane', 'Affiliation': 'Decipher Biosciences, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Regional Cancer Center West, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, Medicine and Radiation Oncology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Speers', 'Affiliation': 'Department of Radiation Oncology, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Pierce', 'Affiliation': 'Department of Radiation Oncology, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Division of Oncology and Pathology, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1038'] 862,31818843,"Simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis: protocol of a multicentre, prospective, randomised phase III control trial (CSPAC-1).","INTRODUCTION Approximately 50% of pancreatic ductal adenocarcinoma (PDAC) patients are diagnosed with distant metastasis, especially liver metastasis. The current standard treatment for these stage IV patients is palliative chemotherapy. There is increasing agreement that synchronous PDAC and liver metastasis resection may benefit highly selected patients. Thus, the Chinese Study Group for Pancreatic Cancer (CSPAC)-1 trial is being launched to establish a strategy for selecting PDAC patients with liver oligometastases who may benefit from synchronous resection after conversion chemotherapy. METHODS AND ANALYSIS In this study, liver oligometastasis is defined as no more than three metastatic lesions irrespective of their distribution within the liver lobes. The trial contains two steps. In the first step, 1000 to 1200 needle biopsy-confirmed PDAC patients with liver oligometastases are eligible for inclusion. Candidates will receive first-line chemotherapy. The RECIST V.1.1 criteria combined with tumour markers will be applied to evaluate the tumour response to chemotherapy every two cycles. Pancreatic cancer and hepatic metastasis resectability will be identified by multidisciplinary teams. Approximately 300 patients who meet our criteria will enter the second step and be randomly assigned at a 1:1 ratio to simultaneous resection of the primary pancreatic cancer lesion and liver oligometastases if no extensive metastatic sites are found during surgery or standard chemotherapy. Postoperative chemotherapy is recommended, and regimen selection should be based on the preoperative chemotherapy regimen. The primary endpoint is real overall survival (from enrolment to death). This study was activated in July 2018 and is expected to complete accrual within 5 years. ETHICS AND DISSEMINATION This trial has been approved by the Clinical Research Ethics Committee of Fudan University Shanghai Cancer Centre. Written informed consent will be obtained from all participants. Serious adverse events will be reported. Trial results will be submitted for peer-reviewed publication. TRIAL REGISTRATION NUMBER NCT03398291; Pre-results.",2019,The RECIST V.1.1 criteria combined with tumour markers will be applied to evaluate the tumour response to chemotherapy every two cycles.,"['pancreatic cancer with liver oligometastasis', 'PDAC patients with liver oligometastases who may benefit from synchronous resection after conversion chemotherapy', '1200 needle biopsy-confirmed PDAC patients with liver oligometastases are eligible for inclusion', 'Fudan University Shanghai Cancer Centre', 'Approximately 300 patients who meet our criteria will enter the second step']","['surgery or standard chemotherapy', 'conversion chemotherapy versus standard therapy']","['Pancreatic Cancer', 'real overall survival', 'Pancreatic cancer and hepatic metastasis resectability']","[{'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver (disorder)'}]",1200.0,0.0766649,The RECIST V.1.1 criteria combined with tumour markers will be applied to evaluate the tumour response to chemotherapy every two cycles.,"[{'ForeName': 'Miaoyan', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China yuxianjun@fudanpci.org xujin@fudanpci.org.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China yuxianjun@fudanpci.org xujin@fudanpci.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033452'] 863,31826893,Cost-effectiveness of telephone coaching for physically inactive ambulatory care hospital patients: economic evaluation alongside the Healthy4U randomised controlled trial.,"OBJECTIVE To assess whether telephone coaching is a cost-effective method for increasing physical activity and health-related quality of life for insufficiently active adults presenting to an ambulatory care clinic in a public hospital. DESIGN An economic evaluation was performed alongside a randomised controlled trial. SETTING Participants were recruited from an ambulatory care clinic in a public hospital in regional Australia. PARTICIPANTS Seventy-two adults (aged 18-69) deemed insufficiently physically active via self-report. INTERVENTIONS Participants were randomised to either an intervention group that received an education session and eight sessions of telephone coaching over a 12-week period, or to a control group that received the education session only. The intervention used in the telephone coaching was integrated motivational interviewing and cognitive behavioural therapy. OUTCOME MEASURES The primary health outcome was change in moderate-to-vigorous physical activity (MVPA), objectively measured via accelerometry. The secondary outcome was the quality-adjusted life-year (QALY) determined by the 12-item Short Form Health Survey Questionnaire. Outcome data were measured at baseline, postintervention (3 months) and follow-up (6 months). Incremental cost-effectiveness ratios (ICERs) were calculated for each outcome. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS The mean intervention cost was $279±$13 per person. At 6 months follow-up, relative to control, the intervention group undertook 18 more minutes of daily MVPA at an ICER of $15/min for each additional minute of MVPA. With regard to QALYs, the intervention yielded an ICER of $36 857 per QALY gained. Sensitivity analyses indicated that results were robust to varied assumptions. CONCLUSION Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients. Additional research could explore the potential economic impact of the intervention from a broader healthcare perspective. TRIAL REGISTRATION NUMBER ANZCTR: ACTRN12616001331426.",2019,"CONCLUSION Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients.","['physically active ambulatory care hospital patients', 'insufficiently active adults presenting to an ambulatory care clinic in a public hospital', 'Seventy-two adults (aged 18-69) deemed insufficiently physically active via self-report', 'physically inactive ambulatory care hospital patients', 'Participants were recruited from an ambulatory care clinic in a public hospital in regional Australia']","['telephone coaching', 'education session and eight sessions of telephone coaching', 'Telephone coaching', 'telephone coaching was integrated motivational interviewing and cognitive behavioural therapy', 'MVPA']","['Cost-effectiveness', 'mean intervention cost', 'Incremental cost-effectiveness ratios (ICERs', 'quality-adjusted life-year (QALY) determined by the 12-item Short Form Health Survey Questionnaire', 'change in moderate-to-vigorous physical activity (MVPA), objectively measured via accelerometry']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}]",72.0,0.117753,"CONCLUSION Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barrett', 'Affiliation': 'Health Promotion, Bendigo Health - Bendigo Hospital Campus, Bendigo, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Begg', 'Affiliation': 'La Trobe Holsworth Research Initiative, La Trobe University, Bendigo, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kingsley', 'Affiliation': 'La Trobe Holsworth Research Initiative, La Trobe University, Bendigo, Victoria, Australia M.Kingsley@latrobe.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-032500'] 864,31826896,"Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT.","OBJECTIVE To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT). DESIGN A two-arm, randomised feasibility trial with a mixed-methods process evaluation. SETTING Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK. PARTICIPANTS Fathers with overweight or obesity and their children aged 4-11 years. INTERVENTION Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions. OUTCOMES Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews. RESULTS The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m 2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as 'good/very good' and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6). CONCLUSIONS The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop-go criteria. TRIAL REGISTRATION NUMBER ISRCTN16724454.",2019,"Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6). ","['Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK', '43 men, 48% of the target sample size; the mean body mass index was 30.2\u2009kg/m 2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation', 'Fathers with overweight or obesity and their children aged 4-11\u2009years', 'Healthy Dads, Healthy Kids UK, a weight management programme for fathers', 'fathers with overweight or obesity and their primary school-aged children, and (2']","['control (family voucher for a leisure centre) or intervention comprising 9\u2009weekly healthy lifestyle group sessions', 'culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK']","['lifestyle behavioural change', 'Weight loss', 'prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6\u2009months, and through qualitative interviews']","[{'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0557790', 'cui_str': 'Leisure center (environment)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",43.0,0.0832928,"Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6). ","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Griffin', 'Affiliation': 'Department of Health, University of Bath, Bath, Somerset, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manbinder', 'Initials': 'M', 'LastName': 'Sidhu', 'Affiliation': 'Health Services Management Centre, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Burgess', 'Affiliation': 'Fatherhood Institute, Marlborough, Wiltshire, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Entwistle', 'Affiliation': 'Public member, Leamington Spa, Warwickshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kiya', 'Initials': 'K', 'LastName': 'Hurley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'McGee', 'Affiliation': 'Birmingham Community Healthcare NHS Trust, Aston, Birmingham, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Pallan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'School of Education, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK c.b.jolly@bham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033534'] 865,31888543,The effect of distraction techniques on pain and stress during labor: a randomized controlled clinical trial.,"BACKGROUND Pain control and the stress associated with labor and delivery are among the most important issues of health care system. Use of distraction techniques during childbirth is reported to reduce pain and stress of labor. However, there is a limited publication that looked on the effect of distraction techniques on labor pain and stress. Thus, the aim of this study was to determine the effect of distraction techniques on labor pain and stress (primary outcomes), fear of childbirth, length of delivery stages, first minute Apgar score and oxytocin consumption (secondary outcomes). METHODS A randomized controlled clinical trial was conducted on 68 pregnant women. Participants were allocated into two groups (intervention and control groups) by blocked randomization. Participants in the intervention group received distraction techniques in four sessions. Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS once were completed before intervention and again at the 36th week for the W-DEQ and in the active phase for the PSS through interviews. The pain was assessed through VAS during active phase per hour. The length of delivery stages was recorded in the partograph chart. Data were analyzed by independent t-test and ANCOVA. RESULTS The mean of perceived stress during labor in the intervention group was significantly less than that of the control group (AMD: -3.2; 95% CI: - 0.8 to - 6.0; P = 0.01). The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P < 0.001). There was no significant difference between the two groups in terms of fear of childbirth score (AMD: 5.3; 95% CI: 13.0 to - 6.0; P = - 2.3). Moreover, there was no statistically significant difference between the two groups in terms of the active phase of labor (P = 0.504), second stage of delivery (P = 0.928), total length of delivery (P = 0.520), Apgar score (P = 1.000) and frequency of oxytocin consumption (P = 0.622). CONCLUSION According to the results, distraction techniques can reduce the pain and stress of labor, but further studies by using the distraction techniques are needed to reach a decisive conclusion. TRIAL REGISTRATION IRCT2017042910324N39; Name of registry: Iranian Registry of Clinical Trials; Registered 11 September 2017. URL of registry: https://fa.irct.ir/user/trial/10814/view. Date of enrolment of the first participant to the trial: September 2017.",2019,The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P < 0.001).,"['68 pregnant women', 'pain and stress during labor']",['distraction techniques'],"['mean (SD) of pain intensity during labor', 'labor pain and stress (primary outcomes), fear of childbirth, length of delivery stages, first minute Apgar score and oxytocin consumption (secondary outcomes', 'pain and stress of labor', 'labor pain and stress', 'total length of delivery', 'frequency of oxytocin consumption', 'second stage of delivery', 'Apgar score', 'pain', 'active phase of labor', 'Questionnaires of Fear of Childbirth (W-DEQ version A) and PSS', 'fear of childbirth score', 'length of delivery stages', 'mean of perceived stress during labor']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia (finding)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",68.0,0.0584304,The mean (SD) of pain intensity during labor was less than in the intervention and control groups compare to the control group (6.2 vs 7.5; P < 0.001).,"[{'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Amiri', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Esmaeilpour', 'Affiliation': 'Faculty of Education and Psychology, Tabriz University, Tabriz, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Kamalifard', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Ivanbagha', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Khlkhal University of Medical Sciences, Khalkhal, Iran.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2683-y'] 866,31527167,Biomarker Analyses of Response to Cyclin-Dependent Kinase 4/6 Inhibition and Endocrine Therapy in Women with Treatment-Naïve Metastatic Breast Cancer.,"PURPOSE Preclinical data identified the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib as synergistic with antiestrogens in inhibiting growth of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) human breast cancer models. This observation was validated clinically in the randomized, placebo-controlled, phase III PALOMA-2 study. EXPERIMENTAL DESIGN To determine markers of sensitivity and resistance to palbociclib plus letrozole, we performed comprehensive biomarker analyses, investigating the correlation with progression-free survival (PFS), on baseline tumor tissues from PALOMA-2. RESULTS Despite a broad biomarker search, palbociclib plus letrozole demonstrated consistent PFS gains versus placebo plus letrozole, with no single biomarker or cassette of markers associated with lack of benefit from combination treatment. Palbociclib plus letrozole confers efficacy on both luminal A and B patients. Higher CDK4 levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, whereas lower PD-1 levels were associated with greater palbociclib plus letrozole benefit. Tumors with more active growth factor signaling, as exemplified by increased expression of FGFR2 and ERBB3 mRNA, appeared to be associated with greater PFS gain from the addition of palbociclib. CONCLUSIONS These data underscore the importance of CDK4/6 signaling in HR+/HER2- breast cancer and suggest that the interplay between steroid hormone and peptide growth factor signaling could drive dependence on CDK4/6 signaling. See related commentary by Anurag et al., p. 3 .",2020,"Higher CDK4 levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, while lower PD1 levels were associated with greater palbociclib plus letrozole benefit.",['Women'],"['letrozole', 'palbociclib plus letrozole', 'placebo', 'placebo plus letrozole', 'Palbociclib plus letrozole']","['PD1 levels', 'Higher CDK4 levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0617671,"Higher CDK4 levels were associated with endocrine resistance which was mitigated by the addition of palbociclib, while lower PD1 levels were associated with greater palbociclib plus letrozole benefit.","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, California. RFinn@mednet.ucla.edu.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer Inc, Global Product Development Oncology, La Jolla, California.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc, Oncology Translational Research/Computational Biology, La Jolla, California.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Breast Oncology, Institut Curie, and Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of OB&GYN, Brustzentrum der Universität München (LMU), München, Germany.'}, {'ForeName': 'Dongrui R', 'Initials': 'DR', 'LastName': 'Lu', 'Affiliation': 'Pfizer Inc, Clinical Statistics, La Jolla, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc, Department of Clinical Research, San Francisco, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Huang Bartlett', 'Affiliation': 'Pfizer Inc, Global Medical Affairs, Collegeville, Pennsylvania.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0751'] 867,31850848,A Stress Relief App Intervention for Newly Employed Nursing Staff: Quasi-Experimental Design.,"BACKGROUND Most newly employed nurses have limited practical experience, lack problem-solving abilities, and have low resistance to stress, and therefore often opt to resign from the nursing profession. OBJECTIVE This study aimed to assess the effectiveness of a stress relief app (SR_APP) to monitor the stress levels of newly employed nurses. METHODS We conducted a quasi-experiment to assess changes in stress levels of newly employed nurses at a case hospital, in which the experimental group used the SR_APP and the control group did not. In-depth interviews were conducted to reveal insights regarding their stress. The app usage experiences of experimental group members were assessed via a questionnaire. RESULTS All the participants appreciated the experiment and were interested to know more about managing their stress. The experimental group members showed significant differences in heart rate variability scores before and after using the SR_APP, and they reported high levels of intention to use and satisfaction with regard to the SR_APP. CONCLUSIONS The SR_APP can be effective in helping newly employed nurses to manage their stress.",2019,"The experimental group members showed significant differences in heart rate variability scores before and after using the SR_APP, and they reported high levels of intention to use and satisfaction with regard to the SR_APP. ",[],"['stress relief app (SR_APP', 'SR_APP']","['heart rate variability scores', 'high levels of intention to use and satisfaction']",[],"[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0303174,"The experimental group members showed significant differences in heart rate variability scores before and after using the SR_APP, and they reported high levels of intention to use and satisfaction with regard to the SR_APP. ","[{'ForeName': 'I-Chiu', 'Initials': 'IC', 'LastName': 'Chang', 'Affiliation': 'Department of Information Management, National Chung Cheng University, Chia-Yi, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Cheng', 'Affiliation': 'Department of Information Management, National Chung Cheng University, Chia-Yi, Taiwan.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Kung', 'Affiliation': 'Nursing Department, Hsinchu MacKay Memorial Hospital, Hsinchu City, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/15785'] 868,31267576,Predonation fears identify young donors at risk for vasovagal reactions.,"BACKGROUND Extending existing research on the relationship between predonation fear of having blood drawn and risk for vasovagal reactions among young donors, this study assessed the predictive power of specific donation-related fears. STUDY DESIGN AND METHODS After the health screening, high school whole blood donors (59.5% female) were randomly assigned into one of three groups. Group 1 (n = 881) answered a control question about their prior night's sleep. Group 2 (n = 911) answered the sleep question and a question about fear of having blood drawn. Group 3 (n = 924) answered the sleep question, the fear of having blood drawn question, and four questions about specific donation-related fears (seeing blood, needles, pain, and fainting). RESULTS The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions. Fearful donors were more likely to have a vasovagal reaction, even after controlling for other important demographic and health predictors, with odds ratios ranging from 2.17 (95% confidence interval [CI], 1.44-3.27) for fear of fainting to 3.50 (95% CI, 2.34-5.23) for fear of seeing blood. Hours of sleep was not significantly related to vasovagal reaction risk. CONCLUSION Predonation fear identifies donors who are more likely to experience a vasovagal reaction and does so without increasing the risk of such reactions. Accordingly, fear should be assessed during screening to identify those who could benefit from instruction in anxiety management and who might require greater attention to help prevent donor injury.",2019,"The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions.","['After the health screening, high school whole blood donors (59.5% female', 'young donors at risk for vasovagal reactions']","[""control question about their prior night's sleep""]","['sleep question, the fear of having blood drawn question, and four questions about specific donation-related fears (seeing blood, needles, pain, and fainting', 'proportion of vasovagal reactions', 'sleep question and a question about fear of having blood drawn', 'fear of fainting', 'vasovagal reaction risk', 'vasovagal reaction']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",924.0,0.0162926,"The proportion of vasovagal reactions did not differ significantly among the groups, indicating that asking one or more fear questions before donation did not promote reactions.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Janis L', 'Initials': 'JL', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conatser', 'Affiliation': 'Department of Psychology, Ohio University, Athens, Ohio.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Lux', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}, {'ForeName': 'Yasuko', 'Initials': 'Y', 'LastName': 'Erickson', 'Affiliation': 'Mississippi Valley Regional Blood Center, Davenport, Iowa.'}]",Transfusion,['10.1111/trf.15424'] 869,8778451,The relative contribution of optimal nutritional support in cystic fibrosis.,,1996,,['cystic fibrosis'],[],[],"[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],[],,0.0115901,,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kashirskaja', 'Affiliation': 'Department of Cystic Fibrosis,Institue of Clinical Genetics, Russian Academy of Medical Science, Moscow, Russia.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ilangovan', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kapranov', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Simonova', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shabalova', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Rolles', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 870,31906948,In vivo/ex vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine as first-line treatment for uncomplicated falciparum malaria in children: an open label randomized controlled trial in Burkina Faso.,"BACKGROUND Artemisinin-based combination therapy (ACT) is recommended to improve malaria treatment efficacy and limit drug-resistant parasites selection in malaria endemic areas. 5 years after they were adopted, the efficacy and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ), the first-line treatments for uncomplicated malaria were assessed in Burkina Faso. METHODS In total, 440 children with uncomplicated Plasmodium falciparum malaria were randomized to receive either AL or ASAQ for 3 days and were followed up weekly for 42 days. Blood samples were collected to investigate the ex vivo susceptibility of P. falciparum isolates to lumefantrine, dihydroartemisinin (the active metabolite of artemisinin derivatives) and monodesethylamodiaquine (the active metabolite of amodiaquine). The modified isotopic micro test technique was used to determine the 50% inhibitory concentration (IC50) values. Primary endpoints were the risks of treatment failure at days 42. RESULTS Out of the 440 patients enrolled, 420 (95.5%) completed the 42 days follow up. The results showed a significantly higher PCR unadjusted cure rate in ASAQ arm (71.0%) than that in the AL arm (49.8%) on day 42, and this trend was similar after correction by PCR, with ASAQ performing better (98.1%) than AL (91.1%). Overall adverse events incidence was low and not significantly different between the two treatment arms. Ex vivo results showed that 6.4% P. falciparum isolates were resistant to monodesthylamodiaquine. The coupled in vivo/ex vivo analysis showed increased IC50 values for lumefantrine and monodesethylamodiaquine at day of recurrent parasitaemia compared to baseline values while for artesunate, IC50 values remained stable at baseline and after treatment failure (p > 0.05). CONCLUSION These findings provide substantial evidence that AL and ASAQ are highly efficacious for the treatment of uncomplicated malaria in children in Burkina Faso. However, the result of P. falciparum susceptibility to the partner drugs advocates the need to regularly replicate such surveillance studies. This would be particularly indicated when amodiaquine is associated in seasonal malaria chemoprophylaxis (SMC) mass drug administration in children under 5 years in Burkina Faso. Trial registration clinicaltrials, NCT00808951. Registered 05 December 2008,https://clinicaltrials.gov/ct2/show/NCT00808951?cond=NCT00808951&rank=1.",2020,Ex vivo results showed that 6.4% P. falciparum isolates were resistant to monodesthylamodiaquine.,"['440 patients enrolled', '440 children with uncomplicated Plasmodium falciparum malaria', 'uncomplicated malaria in children in Burkina Faso', 'children under 5\xa0years in Burkina Faso', 'uncomplicated falciparum malaria in children']","['amodiaquine', 'artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ', 'Artemisinin-based combination therapy (ACT', 'AL or ASAQ', 'artemether-lumefantrine and artesunate-amodiaquine']","['efficacy and safety', 'inhibitory concentration (IC50) values', 'Overall adverse events incidence', 'PCR unadjusted cure rate', 'risks of treatment failure at days 42', 'IC50 values']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600495', 'cui_str': 'IC50'}]",440.0,0.0758084,Ex vivo results showed that 6.4% P. falciparum isolates were resistant to monodesthylamodiaquine.,"[{'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Lingani', 'Affiliation': 'Institut de Recherche en Sciences de la Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, Burkina Faso. lingani10@yahoo.fr.'}, {'ForeName': 'Léa Nadège', 'Initials': 'LN', 'LastName': 'Bonkian', 'Affiliation': 'Unité de Recherche sur le Paludisme et Maladies Tropicales Négligées, Centre Muraz, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Isidore', 'Initials': 'I', 'LastName': 'Yerbanga', 'Affiliation': 'Unité de Recherche Clinique de Nanoro (URCN), Nanoro, Burkina Faso.'}, {'ForeName': 'Adama', 'Initials': 'A', 'LastName': 'Kazienga', 'Affiliation': 'Unité de Recherche Clinique de Nanoro (URCN), Nanoro, Burkina Faso.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valéa', 'Affiliation': 'Institut de Recherche en Sciences de la Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, Burkina Faso.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Institut de Recherche en Sciences de la Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, Burkina Faso.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, Burkina Faso.'}, {'ForeName': 'Petronella Francisca', 'Initials': 'PF', 'LastName': 'Mens', 'Affiliation': 'Department of Medical Microbiology, Experimental Parasitology Unit, Amsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk D F H', 'Initials': 'HDFH', 'LastName': 'Schallig', 'Affiliation': 'Department of Medical Microbiology, Experimental Parasitology Unit, Amsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Ravinetto', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""d'Alessandro"", 'Affiliation': 'Medical Research Council Unit, The Gambia, Disease Control & Elimination Theme, Fajara, The Gambia.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé/Direction Régionale du Centre Ouest (IRSS/DRCO), Nanoro, Burkina Faso.'}]",Malaria journal,['10.1186/s12936-019-3089-z'] 871,31852021,A self-help intervention for reducing time to diagnosis in Indonesian women with breast cancer symptoms.,"OBJECTIVE We investigated the effectiveness of a self-help intervention named PERANTARA, which aims to improve adherence to diagnostic procedures among women with breast cancer (BC) symptoms to reduce the time to a definitive diagnosis. METHODS With a cluster randomized crossover design across four hospitals, PERANTARA and treatment as usual (TAU) or TAU only was provided at successive periods in a randomly determined order. The main outcome was the time between the first medical consultation and the definitive diagnosis. Secondary outcomes were BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L. A linear mixed model analysis was conducted to analyse the outcomes. RESULTS We recruited 132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group. PERANTARA reduced the time to definitive diagnosis by 13.3 days (M [SD]: 25.90 [23.20] in the intervention group vs 39.29 [35.10] in the control group; mean difference = -13.26, 95% CI = -24.51 to -2.00, P = .02). No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status. CONCLUSIONS PERANTARA reduced the time to definitive diagnosis among Indonesian women with BC symptoms. Psychoeducation may be an important addition to regular BC care to prevent undue delays in diagnostic procedures.",2020,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status. ","['132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group', 'women with breast cancer (BC) symptoms', 'Indonesian women with BC symptoms', 'Indonesian women with breast cancer symptoms']",[],"['time between the first medical consultation and the definitive diagnosis', 'BC knowledge, symptoms of anxiety, depression, quality of life, or health status', 'BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L', 'time to definitive diagnosis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",132.0,0.100029,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status. ","[{'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Setyowibowo', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joke A M', 'Initials': 'JAM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Aulia', 'Initials': 'A', 'LastName': 'Iskandarsyah', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Whisnu', 'Initials': 'W', 'LastName': 'Yudiana', 'Affiliation': 'Department of Experimental Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Passchier', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sawitri S', 'Initials': 'SS', 'LastName': 'Sadarjoen', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Dharmayanti F', 'Initials': 'DF', 'LastName': 'Badudu', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': 'Drajat R', 'Initials': 'DR', 'LastName': 'Suardi', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': ""Edith Van't"", 'Initials': 'EV', 'LastName': 'Hof', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5316'] 872,31843840,'Beyond Cancer': a study protocol of a multimodal occupational rehabilitation programme to support breast cancer survivors to return work.,"INTRODUCTION With more women working and surviving breast cancer, issues concerning sustainable employment must be addressed. Support to transition back to work is a gap in survivorship care. This paper describes the feasibility trial protocol for 'Beyond Cancer', a multimodal occupational rehabilitation programme to support breast cancer survivors' return to work. Breast cancer survivors are hypothesised to show improved work status, work capacity and perceived support at work at 6 months postintervention relative to baseline and a historical usual care group. METHODS AND ANALYSIS The prospective feasibility design allows determination of change in primary (work status) as well as secondary outcome measures work capacity and perceived support at work. PARTICIPANTS breast cancer survivors of working age, unable to work in their prediagnosis capacity for >3 months, their employers and a historical usual care group. Key intervention elements: an evidence-based biopsychosocial assessment and health coaching programme, employer education and support, and return to work (RTW) planning and monitoring. Health coaching empowers survivors to return to social function, including work. Employer education and support facilitates communication and improves workplace support. For employers, we predict change in confidence in effectively supporting employees' RTW. Multilevel regression modelling will provide indications of efficacy for primary and secondary outcomes, and thematic analysis will examine perceived efficacy and acceptability. ETHICS AND DISSEMINATION Ethics approval has been granted by Monash and Curtin University Human Research Ethics Committees (HREC: 13300, HRE2019-0280, respectively). The evaluation of this innovative programme will provide the foundation for an Randomised Controlled Trial (RCT) and national roll-out, thus improving the quality of life of those who have been directly affected by breast cancer across Australia. Results will be published in peer-reviewed journals, presented at relevant conferences and disseminated to survivorship-focused organisations. TRIAL REGISTRATION NUMBER Registered trial with the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12618001985279); Pre-results.",2019,"Breast cancer survivors are hypothesised to show improved work status, work capacity and perceived support at work at 6 months postintervention relative to baseline and a historical usual care group. ","['breast cancer survivors of working age, unable to work in their prediagnosis capacity for >3 months, their employers and a historical usual care group', 'Breast cancer survivors']","['multimodal occupational rehabilitation programme', 'evidence-based biopsychosocial assessment and health coaching programme, employer education and support, and return to work (RTW) planning and monitoring']",['efficacy and acceptability'],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0985574,"Breast cancer survivors are hypothesised to show improved work status, work capacity and perceived support at work at 6 months postintervention relative to baseline and a historical usual care group. ","[{'ForeName': 'Dianne Melinda', 'Initials': 'DM', 'LastName': 'Sheppard', 'Affiliation': 'Monash University Accident Research Centre, Monash University, Clayton, Victoria, Australia dianne.sheppard@monash.edu.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Frost', 'Affiliation': 'Research and Innovation, MedHealth Group, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jefford', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': ""O'Connor"", 'Affiliation': 'School of Psychology, Curtin University Bentley Campus, Perth, Western Australia, Australia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Halkett', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, Curtin University Bentley Campus, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032505'] 873,31811010,"New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model.","INTRODUCTION Warfarin is an effective anticoagulant and the only oral anticoagulant available for patients with mechanical heart valves. The prothrombin time and the associated international normalised ratio (INR) are routinely tested to monitor the response to anticoagulation therapy in patients. Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoagulation drugs. Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate. We propose modern internet technology as a platform to build a warfarin anticoagulation follow-up system after valve replacement surgery. This system will provide doctors and patients with more standardised and safer follow-up methods as well as a method to further reduce the risk of warfarin anticoagulation-related complications and improve its therapeutic effects. METHODS AND ANALYSIS A prospective, multicentre, randomised, controlled trial will be conducted. A total of 700 patients who require long-term warfarin anticoagulation monitoring after heart valve replacement will be enrolled and randomly divided at a 1:1 ratio into a traditional outpatient anticoagulation management group and a group undergoing a new method of management based on the internet technology with follow-up for 1 year. Differences in the percentage of time in the therapeutic range (TTR), drug dose adjustments, bleeding/thrombosis and other related complications will be observed. The primary endpoint is the difference in the TTR between the two groups. The purpose of this study is to explore a safer and more effective mode of doctor-patient interaction and communication in the internet era. As of 13 July 2019, 534 patients had been enrolled. ETHICS AND DISSEMINATION This study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. The results will be published in a peer-reviewed medical journal. TRIAL REGISTRATION NUMBER ChiCTR1800016204.",2019,"Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate.","['Beijing Anzhen Hospital, Capital Medical University', 'patients with mechanical heart valves', 'Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoagulation drugs', 'heart valve surgery', '700 patients who require long-term warfarin anticoagulation monitoring after heart valve replacement', '13 July 2019, 534 patients had been enrolled']","['traditional outpatient anticoagulation management group and a group undergoing a new method of management based on the internet technology with follow-up for 1\u2009year', 'Warfarin']","['percentage of time in the therapeutic range (TTR), drug dose adjustments, bleeding/thrombosis', 'prothrombin time and the associated international normalised ratio (INR']","[{'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C3697840', 'cui_str': 'Mechanical heart valve replacement'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449768', 'cui_str': 'Measured to (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement (procedure)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0678766', 'cui_str': 'Drug dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0525032', 'cui_str': 'INR'}]",534.0,0.0486116,"Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate.","[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuehuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jinglun', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China zhanghb2318@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-032949'] 874,31818841,Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial.,"INTRODUCTION The past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries. METHODS AND ANALYSIS This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle. ETHICS AND DISSEMINATION The RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings. TRIAL REGISTRATION NUMBER Current Controlled Trials registry (ISRCTN16339434).",2019,"This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling.",['problem gambling in Switzerland'],"['motivational interviewing and cognitive behavioural therapy', 'web-based self-help tool']","['money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity', 'number of days one has gambled in the last 30 days']","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.270937,"This two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland christian.baumgartner@isgf.uzh.ch.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bilevicius', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khazaal', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Achab', 'Affiliation': 'WHO Collaborating Centre for Training and Research in Mental Health, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Schaaf', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Haug', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Zurich, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-032110'] 875,31886280,The Role of Peer Support Education Model in Management of Glucose and Lipid Levels in Patients with Type 2 Diabetes Mellitus in Chinese Adults.,"Aims To investigate the effect of peer support education model on the levels of glucose and lipids in patients with type 2 diabetes mellitus in China. Methods 120 type 2 diabetes mellitus patients (T2DM) were assigned to two groups randomly from December 2016 to October 2017. Group 1 was trained on basic diabetic medical knowledge by a professional medical staff. After 8 weeks of studying, these specially trained patients then trained the patients of Group 2. Results It was found that after 3 months of intervention, the levels of fasting blood glucose, triglycerides, glycosylated hemoglobin, total cholesterol, and low-density lipoprotein cholesterol were significantly decreased for the two groups ( p < 0.05). However, with the prolongation of time, there were no significant changes in the two groups in the above indices ( p > 0.05) after 6 months, and the result was the same after strafing sex, age, and education level. Meanwhile, there was no significant difference in decreasing glucose and lipid level between the two groups' participants ( p > 0.05). Conclusion It was found that both the peer support education model and medical staff education model have a better short-term effect on blood glucose and lipid levels in patients with type 2 diabetes. As there is no difference of effect between the two methods of training, the peer support education model can be widely used in diabetes education.",2019,"As there is no difference of effect between the two methods of training, the peer support education model can be widely used in diabetes education.","['Patients with Type 2 Diabetes Mellitus in Chinese Adults', 'patients with type 2 diabetes mellitus in China', 'patients with type 2 diabetes', '120 type 2 diabetes mellitus patients (T2DM']","['peer support education model', 'Peer Support Education Model']","['decreasing glucose and lipid level', 'levels of fasting blood glucose, triglycerides, glycosylated hemoglobin, total cholesterol, and low-density lipoprotein cholesterol', 'blood glucose and lipid levels', 'levels of glucose and lipids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",120.0,0.013937,"As there is no difference of effect between the two methods of training, the peer support education model can be widely used in diabetes education.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Endocrinology Department, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Endocrinology Department, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Endocrinology Department, Peking University International Hospital, Beijing, China.'}]",Journal of diabetes research,['10.1155/2019/5634030'] 876,31882508,Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial.,"BACKGROUND/AIM To evaluate whether topical use of a film-forming silicone gel (StrataXRT®) could reduce radiation dermatitis compared to a moisturizing cream (X-derm®) in patients receiving whole breast radiotherapy. PATIENTS AND METHODS A total of 56 patients with breast cancer were randomized to use StrataXRT or X-derm. The severity of radiation dermatitis was graded using physiological skin parameters, clinician-assessed visual rating scales and patient-reported symptoms. Changes in these parameters from baseline to 4 weeks post-radiotherapy were evaluated every two weeks. RESULTS Two-way repeated-measures ANOVA revealed different patterns of changes in the erythema index (F=3.609, p=0.008) and melanin index (F=3.475, p=0.015). The post hoc analysis demonstrated a significantly lower erythema index and melanin index in the patients allocated to the StrataXRT group. CONCLUSION The use of StrataXRT can reduce radiation dermatitis with respect to objectively measured physiological skin parameters. The results of the present study will support the feasibility of conducting a larger randomized controlled trial.",2020,"repeated-measures ANOVA revealed different patterns of changes in the erythema index (F=3.609, p=0.008) and melanin index (F=3.475, p=0.015).","['patients receiving whole breast radiotherapy', '56 patients with breast cancer']","['Radiotherapy', 'StrataXRT or X-derm', 'StrataXRT', 'moisturizing cream (X-derm®', 'film-forming silicone gel (StrataXRT®', 'Film-forming Silicone Gel']","['physiological skin parameters, clinician-assessed visual rating scales', 'melanin index', 'severity of radiation dermatitis', 'erythema index', 'erythema index and melanin index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0599034', 'cui_str': 'Silicone Gels'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",56.0,0.0695606,"repeated-measures ANOVA revealed different patterns of changes in the erythema index (F=3.609, p=0.008) and melanin index (F=3.475, p=0.015).","[{'ForeName': 'Songmi', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kihoon', 'Initials': 'K', 'LastName': 'Sung', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea novalis@gilhospital.com.'}, {'ForeName': 'Hyun Ju', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Young Eun', 'Initials': 'YE', 'LastName': 'Choi', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Young Kyu', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jeong Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Joo-Young', 'Initials': 'JY', 'LastName': 'Roh', 'Affiliation': 'Department of Dermatology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea.'}]","In vivo (Athens, Greece)",['10.21873/invivo.11790'] 877,31611264,Dimethyl fumarate decreases neurofilament light chain in CSF and blood of treatment naïve relapsing MS patients.,"OBJECTIVES In a prospective phase IV trial of the first-line oral treatment dimethyl fumarate (DMF), we examined dynamics of neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples collected over 12 months from relapsing-remitting multiple sclerosis (RRMS) patients. NFL changes were related to disease activity. METHODS We examined NFL levels by single-molecule array in 88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52). Plasma/sera were collected at baseline, and 1, 3, 6 and 12 months after DMF. CSF samples were collected at baseline and 12 months after DMF. RESULTS NFL concentration in CSF, plasma and serum correlated highly (p<0.0001 for all), but plasma levels were only 76.9% of paired serum concentration. After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively). Significant reduction in blood was observed after 6 and 12 months treatment compared with baseline (p<0.01 and p<0.0001, respectively) and to placebo (p<0.0001). Patients with NFL above the 807.5 pg/mL cut-off in CSF had 5.0-times relative risk of disease activity (p<0.001). CONCLUSIONS This study provides Class II evidence that first-line DMF reduces NFL in both blood and CSF after 6 months and normalises CSF levels in 73% of patients. High NFL concentration in CSF after a year reflected disease activity. NFL levels were higher in serum than in plasma, which should be considered when NFL is used as a biomarker.",2019,"After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively).","['88 CSF, 348 plasma and 131 sera from treatment-naïve RRMS patients (n=52), healthy controls (n=23) and a placebo group matched by age, sex and NFL (n=52', 'relapsing-remitting multiple sclerosis (RRMS) patients']","['placebo', 'Dimethyl fumarate', 'first-line oral treatment dimethyl fumarate (DMF']","['Plasma/sera', 'blood', 'NFL concentration in CSF, plasma and serum', 'neurofilament light (NFL) chain in serum, plasma and cerebrospinal fluid (CSF) samples', 'CSF samples', 'normalises CSF levels', 'plasma levels', 'NFL concentration', 'NFL levels']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C1292530', 'cui_str': 'Cerebrospinal fluid specimen'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",88.0,0.0387063,"After 12 months of DMF treatment, NFL concentration decreased by 73%, 69% and 55% in the CSF, serum and plasma (p<0.0001, respectively).","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sejbaek', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark Tobias.Sejbaek.Mathiesen@rsyd.dk.'}, {'ForeName': 'Helle Hvilsted', 'Initials': 'HH', 'LastName': 'Nielsen', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Penner', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Mendoza', 'Affiliation': 'Value Based Medicine, Biogen Idec Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nellie Anne', 'Initials': 'NA', 'LastName': 'Martin', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Maria Louise', 'Initials': 'ML', 'LastName': 'Elkjaer', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Mads Henrik', 'Initials': 'MH', 'LastName': 'Ravnborg', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Illes', 'Affiliation': 'Neurology, Odense Universitetshospital, Odense, Denmark.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-321321'] 878,31862329,Computerized Advisory Decision Support for Cardiovascular Diseases in Primary Care: A Cluster Randomized Trial.,"PURPOSE The purpose of this research was to evaluate the impact of an outpatient computerized advisory clinical decision support system (CDSS) on adherence to guideline-recommended treatment for heart failure, atrial fibrillation, and hyperlipidemia. METHODS Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either access or no access to an advisory CDSS integrated into the electronic medical record. For patients with an outpatient visit, the CDSS determined if they had heart failure with reduced ejection fraction, hyperlipidemia, or atrial fibrillation; and if so, was the patient receiving guideline-recommended treatment. In the intervention group, an alert was visible in the medical record if there was a discrepancy between current and guideline-recommended treatment. Clicking the alert displayed the treatment discrepancy and recommended treatment. Outcomes included prescribing patterns, self-reported use of decision aids, and self-reported efficiency. The trial was conducted between May 1 and November 15, 2016, and incorporated 16,310 patient visits. RESULTS The advisory CDSS increased adherence to guideline-recommended treatment for heart failure (odds ratio [OR] 7.6, 95% confidence interval [CI], 1.2, 47.5) but had no impact in atrial fibrillation (OR 0.94, 95% CI 0.15, 5.94) or hyperlipidemia (OR 1.1, 95% CI 0.6, 1.8). Clinicians with access to the CDSS self-reported greater use of risk assessment tools for heart failure (3.6 [1.1] vs 2.7 [1.0], mean [standard deviation] on a 5-point scale) but not for atrial fibrillation or hyperlipidemia. The CDSS did not impact self-assessed efficiency. The overall usage of the CDSS was low (19%). CONCLUSIONS A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.",2020,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"['May 1 and November 15, 2016 and incorporated 16,310 patient visits', 'Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either', 'Primary Care']","['outpatient computerized advisory clinical decision support system (CDSS', 'access or no access to an advisory CDSS integrated into the electronic medical record']","['hyperlipidemia', 'prescribing patterns, self-reported use of decision aids and self-reported efficiency', 'heart failure with reduced ejection fraction, hyperlipidemia, and/or atrial fibrillation', 'overall usage of the CDSS', 'atrial fibrillation or hyperlipidemia', 'atrial fibrillation', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",,0.0365495,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'McKie', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. Electronic address: mckie.paul@mayo.edu.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Anesthesiology, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Maya E', 'Initials': 'ME', 'LastName': 'Kessler', 'Affiliation': 'Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rickey E', 'Initials': 'RE', 'LastName': 'Carter', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Pencille', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Branden C', 'Initials': 'BC', 'LastName': 'Hickey', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chaudhry', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.10.039'] 879,31881390,Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.,"BACKGROUND Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION National Clinical Trial (NCT) Identifier: NCT03925883.",2020,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. ","['collaboration with a large community health center whose patient population is 37% Latino', 'community health centers', 'Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy']","['targeted navigation program', 'precision health intervention', 'patient navigation or usual care']","['overall and by probability stratum', 'time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers', 'colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.111953,"This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. ","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA. Electronic address: Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Johnson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Schneider', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Mummadi', 'Affiliation': 'Northwest Permanente Medical Group, Portland, OR, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'Sea Mar Community Health Centers, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105920'] 880,31805983,Investigating modifications to participant information materials to improve recruitment into a large randomized trial.,"BACKGROUND Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. METHODS Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630). RESULTS The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94-1.17) and 1.10 (95% CI 0.94-1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33). CONCLUSIONS Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.",2019,"However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33). ",['Participants who declined to participate in the HPS2-THRIVE trial'],[],[],"[{'cui': 'C2938208', 'cui_str': 'Thrive'}]",[],[],,0.180909,"However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33). ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wincott', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rejive', 'Initials': 'R', 'LastName': 'Dayanandan', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lay', 'Affiliation': 'Clinical Trial Service Unit & Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. jane.armitage@ndph.ox.ac.uk.'}]",Trials,['10.1186/s13063-019-3779-4'] 881,31806052,Compression therapy following ClariVein® ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA).,"BACKGROUND Endovenous treatment of varicose veins has increased in popularity over the last decade. There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this intervention. The National Institute for Clinical Excellence Guideline Development Group has advocated further research to evaluate the clinical and cost-effectiveness of this post-procedure intervention. In addition to this, the duration of compression bandaging also warrants clarification. METHODS Ethical approval for the study was obtained from the Singhealth Centralised Institutional Review Board (CIRB Ref: 2017/2710). Consent to enter the study will be sought from each participant only after a full explanation has been given, an information leaflet offered and time allowed for consideration. Signed participant consent will be obtained. Patients will be randomised to either compression (group A) or no compression (group B). The primary aim of the study is to assess the patient's pain scores for the first 10 days post procedure using a visual analogue scale. Secondary aims include an assessment of patient compliance with compression, quality of life scores, clinical effectiveness, rates of bruising and phlebitis, time taken to return to normal activities, patient satisfaction and occlusion rate at 6 months. DISCUSSION The purpose of this study is to examine the effect of compression therapy in patients having mechano-chemical ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. This study may provide clarification on the role of compression therapy in patients undergoing MOCA. TRIAL REGISTRATION ClinicalTrials.gov, NCT03685838. Registered on 26 September 2018.",2019,"There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this intervention.","['patients undergoing MOCA', 'patients having mechano-chemical ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device']","['compression (group A) or no compression', 'ClariVein® ablation therapy', 'COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA', 'Compression therapy', 'compression therapy']","[""patient's pain scores"", 'patient compliance with compression, quality of life scores, clinical effectiveness, rates of bruising and phlebitis, time taken to return to normal activities, patient satisfaction and occlusion rate at 6\u2009months']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441474', 'cui_str': 'Chemical destruction (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441474', 'cui_str': 'Chemical destruction (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0876063,"There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this intervention.","[{'ForeName': 'Doireann P', 'Initials': 'DP', 'LastName': 'Joyce', 'Affiliation': 'Department of Vascular Surgery, Galway University Hospital, Galway, Ireland.'}, {'ForeName': 'Stewart R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Department of Vascular Surgery, Galway University Hospital, Galway, Ireland.'}, {'ForeName': 'Charyl J Q', 'Initials': 'CJQ', 'LastName': 'Yap', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Tze T', 'Initials': 'TT', 'LastName': 'Chong', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Tjun Y', 'Initials': 'TY', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore. tang.tjun.yip@singhealth.com.sg.'}]",Trials,['10.1186/s13063-019-3787-4'] 882,31313062,The Impact of Treatment Expectations on Exposure Process and Treatment Outcome in Childhood Anxiety Disorders.,"This study examined the relationship between caregivers' and youths' treatment expectations and characteristics of exposure tasks (quantity, mastery, compliance) in cognitive-behavioral therapy (CBT) for childhood anxiety. Additionally, compliance with exposure tasks was tested as a mediator of the relationship between treatment expectations and symptom improvement. Data were from youth (N = 279; 7-17 years old) enrolled in the Child/Adolescent Anxiety Multimodal Study (CAMS) and randomized to cognitive-behavioral therapy (CBT) or the combination of CBT and sertraline for the treatment of separation anxiety disorder, generalized anxiety disorder, and social phobia. Caregivers and youth independently reported treatment expectations prior to randomization, anxiety was assessed pre- and post-treatment by independent evaluators blind to treatment condition, and exposure characteristics were recorded by the cognitive-behavioral therapists following each session. For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment. Additionally, more positive parent treatment expectations were related to a greater number and percentage of sessions with exposure. More positive youth treatment expectations were associated with greater mastery during sessions focused on exposure. Findings underscore the importance of addressing parents' and youths' treatment expectations at the outset of therapy to facilitate engagement in exposure and maximize therapeutic gains.",2020,"For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment.","['Childhood Anxiety Disorders', 'Data were from youth (N\u2009=\u2009279; 7-17\xa0years old) enrolled in the Child/Adolescent Anxiety Multimodal Study (CAMS) and randomized to', 'for the treatment of separation anxiety disorder, generalized anxiety disorder, and social phobia', 'childhood anxiety']","['cognitive-behavioral therapy (CBT', 'cognitive-behavioral therapy (CBT) or the combination of CBT and sertraline']",['anxiety symptoms'],"[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003477', 'cui_str': 'Separation Anxiety Disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0159607,"For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment.","[{'ForeName': 'Monica S', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Room 47-417B, Los Angeles, CA, 90095, USA. MSWu@mednet.ucla.edu.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Caporino', 'Affiliation': 'American University, Washington, DC, USA.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Room 47-417B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Pérez', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Room 47-417B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Room 47-417B, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'New York State Psychiatric Institute-Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Room 47-417B, Los Angeles, CA, 90095, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00574-x'] 883,30639342,"Exogenous testosterone and the monoamine-oxidase A polymorphism influence anger, aggression and neural responses to provocation in males.","Testosterone and the monoamine oxidase-A (MAOA) polymorphism are potential neuromodulators for aggression. By acting on similar brain circuits, they might interactively influence human behavior. The current study investigates the causal role of testosterone on aggression-related brain activity and the potential interaction with the MAOA polymorphism. In a double-blind process, 93 healthy males received a testosterone or placebo gel. In an fMRI session, participants performed a Taylor aggression paradigm in which they received provoking feedback and could afterwards decide how aggressively they would react. Testosterone and cortisol levels as well as subjective anger were assessed prior and after the task. Circulating testosterone levels were higher in carriers of the long compared to the short MAOA allele. An interaction of the MAOA polymorphism and testosterone administration was identified in the cuneus, where short allele carriers in the placebo group showed diminished activity in the decision period. Task-related anger was significantly higher in this group. Overall, a mesocorticolimbic network was implicated in processing of high versus low provoking feedback, and core hubs of the default mode network were implicated in the subsequent decision after high versus low provocation. Testosterone administration increased activation in this network. The data provides evidence for an interaction of the MAOA polymorphism and exogenous testosterone on anger and suggests that interactive effects on the brain signal could underlie differential emotional reactivity. The increased default mode activation in the testosterone group suggests an enhanced engagement of social cognition related regions possibly supporting responsivity towards social provocation. This article is part of the Special Issue entitled 'Current status of the neurobiology of aggression and impulsivity'.",2019,Task-related anger was significantly higher in this group.,"['males', '93 healthy males']","['testosterone', 'Exogenous testosterone', 'Testosterone', 'testosterone or placebo gel']","['Testosterone and cortisol levels', 'Task-related anger', 'Circulating testosterone levels']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",93.0,0.148075,Task-related anger was significantly higher in this group.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wagels', 'Affiliation': 'Institute of Neuroscience and Medicine: JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich, Jülich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen, Germany. Electronic address: l.wagels@fz-juelich.de.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Votinov', 'Affiliation': 'Institute of Neuroscience and Medicine: JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich, Jülich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Kellermann', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen, Germany; JARA - Translational Brain Medicine, Aachen-Jülich, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Konzok', 'Affiliation': 'Department of Medical Psychology, Psychological Diagnostics and Research Methodology, University of Regensburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Institue of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'Institue of Psychology and Education, Ulm University, Ulm, Germany; Key Laboratory for NeuroInformation/Center for Information in Medicine, School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen, Germany; University Hospital, University of Düsseldorf, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Eisert', 'Affiliation': 'Institute of Pharmacology and Toxicology, Medical Faculty of RWTH Aachen University, Aachen, Germany; Hospital Pharmacy, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Cordian', 'Initials': 'C', 'LastName': 'Beyer', 'Affiliation': 'Institute of Neuroanatomy, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'Institute of Neuroscience and Medicine: JARA-Institute Brain Structure Function Relationship (INM 10), Research Center Jülich, Jülich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen, Germany.'}]",Neuropharmacology,['10.1016/j.neuropharm.2019.01.006'] 884,31833064,A pilot randomised controlled trial of the management of systolic blood pressure during endovascular thrombectomy for acute ischaemic stroke.,"It is unknown whether systolic blood pressure augmentation during endovascular thrombectomy improves clinical outcomes. This pilot randomised controlled trial aimed to assess the feasibility of differential systolic blood pressure targeting during endovascular thrombectomy procedures for anterior circulation ischaemic stroke. Fifty-one eligible patients fulfilling the national criteria for endovascular thrombectomy were randomly assigned to receive either standard or augmented systolic blood pressure management from the start of anaesthesia to recanalisation of the target vessel. Systolic blood pressure targets for the standard and augmented groups were 130-150 mmHg and 160-180 mmHg, respectively. The study achieved all feasibility targets, including a recruitment rate of 3.5 participants per week and median (IQR [range]) of mean systolic blood pressure separation between groups of 139 (135-143 [115-154]) vs. 167 (150-175 [113-188]) mmHg, p < 0.001. Data completeness was 99%. Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data. There were no safety concerns with trial procedures. In conclusion, a large randomised controlled efficacy trial of standard vs. augmented systolic blood pressure management during endovascular thrombectomy is feasible.",2020,"Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data.","['acute ischaemic stroke', 'anterior circulation ischaemic stroke', 'Fifty-one eligible patients fulfilling the national criteria for endovascular thrombectomy']","['differential systolic blood pressure targeting during endovascular thrombectomy procedures', 'standard vs. augmented systolic blood pressure management', 'standard or augmented systolic blood pressure management']","['mean systolic blood pressure separation', 'Systolic blood pressure targets', 'systolic blood pressure augmentation', 'systolic blood pressure']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",51.0,0.154022,"Independent functional recovery at 90 days (modified Rankin Scale 0, 1 or 2) was achieved in 30 (59%) patients, which is consistent with previously published data.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Diprose', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Eom', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Robertson', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Short', 'Affiliation': 'Department of Anaesthesia and Peri-operative Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brew', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Caldwell', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'McGuinness', 'Affiliation': 'Department of Radiology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Barber', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]",Anaesthesia,['10.1111/anae.14940'] 885,31532029,"Ketamine effects on default mode network activity and vigilance: A randomized, placebo-controlled crossover simultaneous fMRI/EEG study.","In resting-state functional connectivity experiments, a steady state (of consciousness) is commonly supposed. However, recent research has shown that the resting state is a rather dynamic than a steady state. In particular, changes of vigilance appear to play a prominent role. Accordingly, it is critical to assess the state of vigilance when conducting pharmacodynamic studies with resting-state functional magnetic resonance imaging (fMRI) using drugs that are known to affect vigilance such as (subanesthetic) ketamine. In this study, we sought to clarify whether the previously described ketamine-induced prefrontal decrease of functional connectivity is related to diminished vigilance as assessed by electroencephalography (EEG). We conducted a randomized, double-blind, placebo-controlled crossover study with subanesthetic S-Ketamine in N = 24 healthy, young subjects by simultaneous acquisition of resting-state fMRI and EEG data. We conducted seed-based default mode network functional connectivity and EEG power spectrum analyses. After ketamine administration, decreased functional connectivity was found in medial prefrontal cortex whereas increased connectivities were observed in intraparietal cortices. In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition. Frontal connectivity is negatively related to EEG gamma and theta activity while a positive relationship is found for parietal connectivity and EEG delta power. Our results suggest a direct relationship between ketamine-induced functional connectivity changes and the concomitant decrease of vigilance in EEG. The observed functional changes after ketamine administration may serve as surrogate end points and provide a neurophysiological framework, for example, for the antidepressant action of ketamine (trial name: 29JN1556, EudraCT Number: 2009-012399-28).",2020,"In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition.","['N = 24 healthy, young subjects by simultaneous acquisition of resting-state fMRI and EEG data']","['placebo', 'ketamine', 'Ketamine', 'subanesthetic S-Ketamine']","['shift of energy to slow (delta, theta) and fast (gamma) wave frequencies', 'medial prefrontal cortex', 'functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",24.0,0.0489139,"In EEG, a shift of energy to slow (delta, theta) and fast (gamma) wave frequencies was seen in the ketamine condition.","[{'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Zacharias', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Musso', 'Affiliation': 'Department of Psychiatry, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lammers', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Saleh', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie und Kinderradiologie, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'London', 'Affiliation': 'Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': 'Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Winterer', 'Affiliation': 'Clinical Neuroscience Research Group, Experimental and Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",Human brain mapping,['10.1002/hbm.24791'] 886,31806612,Is congruent movement training more effective than standard visual scanning therapy to ameliorate symptoms of visuospatial neglect? Study protocol of a randomised control trial.,"INTRODUCTION Approximately 30% of all patients with stroke show visuospatial neglect (VSN). Currently, visual scanning therapy (VST) is applied in clinical settings to attenuate neglect symptoms. VST builds on the premise that eye movements to the affected hemifield lead to a concurrent shift of visual attention. Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector. This congruency principle may produce a powerful bias in the motor system, which may counteract the pathological biases in the attentional system of neglect patients. Therefore, an intervention with congruent eye and hand movements may result in greater attenuation of neglect compared with an intervention with single eye movements as applied in standard VST. The current randomised controlled trial will investigate the beneficial effects of this updated version of VST by comparing changes in performance on standard neuropsychological neglect tasks and severity of neglect in activities of daily living. METHODS AND ANALYSIS Thirty VSN patients in the subacute phase poststroke onset will be randomly assigned to one of two groups: congruent eye and hand movement training (experimental group) versus standard VST (control group). Each patient will receive 10 sessions of training, 30 min each, within 2 weeks. Performance on standard neuropsychological neglect tasks, a visual discrimination task, severity of neglect in ADL and eye movement characteristics before and after intervention will be compared for and between both groups. ETHICS AND DISSEMINATION This study has been approved by the ethical committee of the University Medical Centre Utrecht. All subjects will participate voluntarily and will give written informed consent. Results of this study will be published in peer-reviewed scientific journals and presented at international conferences. TRIAL REGISTRATION NUMBER NTR7005.",2019,"Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector.","['Thirty VSN patients in the subacute phase poststroke onset', 'patients with stroke show visuospatial neglect (VSN']","['visual scanning therapy (VST', 'congruent eye and hand movement training (experimental group) versus standard VST', 'standard visual scanning therapy', 'VST']","['visual discrimination task, severity of neglect in ADL and eye movement characteristics']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}]",,0.167482,"Congruent movements with different effectors of the motor system, for example, eye and hand, can produce an even larger boost of attention compared with a single effector.","[{'ForeName': 'Joris A', 'Initials': 'JA', 'LastName': 'Elshout', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands j.a.elshout@uu.nl.'}, {'ForeName': 'Tanja C W', 'Initials': 'TCW', 'LastName': 'Nijboer', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Van der Stigchel', 'Affiliation': 'Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-031884'] 887,31806614,Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme.,"INTRODUCTION Childhood inattention has been linked with poor academic outcomes, and increased lifetime social, occupational and psychiatric morbidity. Children with an acquired brain injury (ABI) are particularly susceptible to attention deficits and may benefit from interventions aimed at enhancing attention. The primary objective of this study is to evaluate the short-term efficacy of the TALI Train programme, compared with a placebo, on the outcome of attention in children with ABI. METHODS AND ANALYSIS The study is a parallel, double-blind, randomised controlled trial. Participants will consist of 80 children with a diagnosis of ABI aged 4-9 years 11 months. Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group). Both programmes are delivered on a touchscreen tablet, and children complete five 20 min sessions per week for a 5-week period at home. Assessment of selective, sustained and executive attention (primary outcomes), and behavioural attention, working memory, social skills and mathematics ability (secondary outcomes) will occur at baseline, post-training, and at 3-month and 6-month follow-up to assess immediate and long-term efficacy of TALI Train compared with placebo. Assessments will be completed at the Royal Children's Hospital in Melbourne, Australia. All assessments and analyses will be undertaken by researchers blinded to group membership. Latent growth curve modelling will be employed to examine primary and secondary outcomes. ETHICS AND DISSEMINATION Ethics approval has been obtained from the Royal Children's Hospital Human Research Ethics Committee (HREC) (38132) and the Monash University HREC (17446). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities. TRIAL REGISTRATION NUMBER ACTRN12619000511134.",2019,"Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group).","['children with ABI', '80 children with a diagnosis of ABI aged 4-9 years 11 months', 'Children with an acquired brain injury (ABI', 'children with acquired brain injury']","['placebo', 'TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group', 'TALI Train programme', 'TALI attention training programme']","['lifetime social, occupational and psychiatric morbidity', 'Assessment of selective, sustained and executive attention (primary outcomes), and behavioural attention, working memory, social skills and mathematics ability (secondary outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",80.0,0.290638,"Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group).","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McKay', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Science, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Richmond', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Science, Monash University, Clayton, Victoria, Australia sally.richmond@monash.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kirk', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Science, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Anderson', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Catroppa', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cornish', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Science, Monash University, Clayton, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032619'] 888,31828291,"Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled Trial.","BACKGROUND Enhanced influenza vaccines may improve protection for older adults, but comparative immunogenicity data are limited. Our objective was to examine immune responses to enhanced influenza vaccines, compared to standard-dose vaccines, in community-dwelling older adults. METHODS Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine. Sera collected from 200 recipients of each vaccine before and at 30-days postvaccination were assessed for antibodies to egg-propagated vaccine strains by hemagglutination inhibition (HAI) and to cell-propagated A/Hong Kong/4801/2014(H3N2) virus by microneutralization (MN). Influenza-specific CD4+ and CD8+ T cell responses were assessed in 20 participants per group. RESULTS Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2) and the MFR in MN to cell-propagated A(H3N2) were statistically significantly higher in the enhanced vaccine groups, compared to the standard-dose vaccine. The MFR in MN to cell-propagated A(H3N2) was highest among rHA recipients (4.7), followed by high-dose (3.4) and MF59-adjuvanted (2.9) recipients, compared to standard-dose recipients (2.3). Similarly, the ratio of postvaccination MN titers among rHA recipients to cell-propagated A(H3N2) recipients was 2.57-fold higher than the standard-dose vaccine, which was statistically higher than the high-dose (1.33-fold) and MF59-adjuvanted (1.43-fold) recipient ratios. Enhanced vaccines also resulted in the boosting of T-cell responses. CONCLUSIONS In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients. CLINICAL TRIALS REGISTRATION NCT03330132.",2019,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients. ","['older adults', '20 participants per group', 'community-dwelling older adults', 'Community-dwelling older adults aged 65-82 years in Hong Kong were randomly allocated (October 2017-January 2018) to receive 2017-2018 Northern hemisphere formulations of a', 'Older Adults']","['standard-dose quadrivalent vaccine, MF59-adjuvanted trivalent vaccine, high-dose trivalent vaccine, or recombinant-hemagglutinin (rHA) quadrivalent vaccine', 'Several Enhanced Influenza Vaccine Options']","['humoral and cell-mediated immune responses', 'Mean fold rises (MFR) in HAI titers to egg-propagated A(H1N1) and A(H3N2', 'Influenza-specific CD4+ and CD8+ T cell responses', 'ratio of postvaccination MN titers']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",200.0,0.0565966,"In this head-to-head comparison, older adults receiving enhanced vaccines showed improved humoral and cell-mediated immune responses, compared to standard-dose vaccine recipients. ","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Ranawaka A P M', 'Initials': 'RAPM', 'LastName': 'Perera', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Valkenburg', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Yat Hung', 'Initials': 'YH', 'LastName': 'Tam', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Jennifer H F', 'Initials': 'JHF', 'LastName': 'Wong', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Athena P Y', 'Initials': 'APY', 'LastName': 'Li', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Hau Chi', 'Initials': 'HC', 'LastName': 'So', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Azziz-Baumgartner', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Fry', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Shivaprakash', 'Initials': 'S', 'LastName': 'Gangappa', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Suryaprakash', 'Initials': 'S', 'LastName': 'Sambhara', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Barr', 'Affiliation': 'World Health Organization Collaborating Centre for Reference and Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Danuta M', 'Initials': 'DM', 'LastName': 'Skowronski', 'Affiliation': 'British Columbia Centre for Disease Control, Vancouver, Canada.'}, {'ForeName': 'J S Malik', 'Initials': 'JSM', 'LastName': 'Peiris', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, China.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1034'] 889,31855785,Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial.,"INTRODUCTION Pulmonary rehabilitation (PR) is known to improve exercise tolerance, mood, and quality of life in patients with chronic respiratory diseases. The aim of this work was to determine whether PR provides long-term benefits in increasing daily life physical activity in patients with chronic sarcoidosis. METHODS This randomized prospective study (registered ClinicalTrials.gov NCT02044939) of 38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016. Patients were assigned to participate in a 2-month PR program (n=20) or receive counseling (n=18). Assessments were performed at baseline, 2 months (end of the PR program), 6months, and 12months, and included daily life physical activity parameters (measured for 5 consecutive days), exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life. The primary outcome was the 12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs). Secondary daily life physical activity outcomes included number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs. RESULTS The primary outcome did not differ between the two groups; mean between-group differences were -13.2min (95% confidence interval [CI]: -76.3 to 49.8) at 6 months and -18.1min (95% CI: -55.7 to 19.4) at 12months. Although PR had no effect on secondary daily life physical activity outcomes, it did significantly increase exercise tolerance at 6 and 12 months and decrease the dyspnea score at 6 months and the fatigue score at 12months. CONCLUSION This trial failed to demonstrate a beneficial effect of PR on daily life physical activity in sarcoidosis patients, suggesting that long-term behavioral programs may be necessary to complement PR.",2019,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"['sarcoidosis patients', 'patients with stage IV sarcoidosis', '38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016', 'patients with chronic respiratory diseases', 'patients with chronic sarcoidosis']","['Pulmonary rehabilitation (PR', 'PR', 'pulmonary rehabilitation', 'PR program']","['secondary daily life physical activity outcomes', 'exercise tolerance', 'daily life physical activity parameters', 'number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs', 'dyspnea score', 'exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life', 'fatigue score', '12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs', 'exercise tolerance, mood, and quality of life', 'daily life physical activity']","[{'cui': 'C0036202', 'cui_str': ""Boeck's Sarcoid""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.178156,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wallaert', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France; University of Lille, 59000 Lille, France. Electronic address: bwallaert@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stelianides', 'Affiliation': 'Division of Pneumology, Bichat Hospital, Paris-Diderot University, 75877, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wemeau', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Grosbois', 'Affiliation': 'FormactionSanté, 59840 Pérenchies, France.'}]",Respiratory medicine and research,['10.1016/j.resmer.2019.10.003'] 890,30774288,Factors Protecting Against Pressure Injuries in Medically Underserved Adults With Spinal Cord Injury: A Qualitative Study.,"Background: Pressure injuries negatively impact quality of life and participation for individuals with spinal cord injury (SCI). Objective: To examine the factors that may protect against the development of medically serious pressure injuries in adults with SCI. Methods: A qualitative analysis was conducted using treatment notes regarding 50 socioeconomically disadvantaged individuals who did not develop medically serious pressure injuries during a 12-month pressure injury prevention intervention program. Results: Eight types of potentially protective factors were identified: meaningful activity, motivation to prevent negative health outcomes, stability/resources, equipment, communication and self-advocacy skills, personal traits, physical factors, and behaviors/activities. Conclusions: Some protective factors (eg, personal traits) may be inherent to certain individuals and nonmodifiable. However, future interventions for this population may benefit from a focus on acquisition of medical equipment and facilitation of sustainable, health-promoting habits and routines. Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI. Further research is needed to understand the complex interplay of risk and protective factors for pressure injuries in adults with SCI, particularly in underserved groups.",2019,"Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI.","['50 socioeconomically disadvantaged individuals who did not develop medically serious pressure injuries during a 12-month pressure injury prevention intervention program', 'socioeconomically disadvantaged individuals with SCI', 'individuals with spinal cord injury (SCI', 'adults with SCI', 'Medically Underserved Adults With Spinal Cord Injury']",['Factors Protecting Against Pressure Injuries'],"['meaningful activity, motivation to prevent negative health outcomes, stability/resources, equipment, communication and self-advocacy skills, personal traits, physical factors, and behaviors/activities']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332679', 'cui_str': 'Pressure injury'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",50.0,0.0241338,"Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI.","[{'ForeName': 'Alix G', 'Initials': 'AG', 'LastName': 'Sleight', 'Affiliation': 'National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Cogan', 'Affiliation': 'Washington DC VA Medical Center, Washington, DC.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'Department of Rehabilitation, Exercise & Nutrition Sciences, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Díaz', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Lucía I', 'Initials': 'LI', 'LastName': 'Floríndez', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Vigen', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Garber', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Florence A', 'Initials': 'FA', 'LastName': 'Clark', 'Affiliation': 'Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, California.'}]",Topics in spinal cord injury rehabilitation,['10.1310/sci2501-31'] 891,31805985,Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda.,"BACKGROUND Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the necessary resources for oxygen delivery. We have previously demonstrated proof-of-concept that solar-powered oxygen (SPO 2 ) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO 2 in children hospitalized with acute hypoxemic respiratory illness across Uganda. METHODS Objectives: Demonstrate efficacy of SPO 2 in children hospitalized with acute hypoxemic respiratory illness. STUDY DESIGN Multi-center, stepped-wedge cluster-randomized trial. SETTING Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia. Site selection: Facilities with pediatric inpatient services lacking consistent O 2 supply on pediatric wards. PARTICIPANTS Children aged < 5 years hospitalized with hypoxemia (saturation < 92%) warranting hospital admission based on clinical judgement. Randomization methods: Random installation order generated a priori with allocation concealment. Study procedure: Patients receive standard of care within pediatric wards with or without SPO 2 system installed. OUTCOME MEASURES Primary: 48-h mortality. Secondary: safety, efficacy, SPO 2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration. Statistical analysis of primary outcome: Linear mixed effects logistic regression model with 48-h mortality (dependent variable) as a function of SPO 2 treatment (before versus after installation), while adjusting for confounding effects of calendar time (fixed effect) and site (random effect). SAMPLE SIZE 2400 patients across 20 health facilities, predicted to provide 80% power to detect a 35% reduction in mortality after introduction of SPO 2 , based on a computer simulation of > 5000 trials. DISCUSSION Overall, our study aims to demonstrate mortality benefit of SPO 2 relative to standard (unreliable) oxygen delivery. The innovative trial design (stepped-wedge, cluster-randomized) is supported by a computer simulation. Capacity building for nursing care and oxygen therapy is a non-scientific objective of the study. If successful, SPO 2 could be scaled across a variety of resource-constrained remote or rural settings in sub-Saharan Africa and beyond. TRIAL REGISTRATION Clinicaltrials.gov, NCT03851783. Registered on 22 February 2019.",2019,"Secondary: safety, efficacy, SPO 2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration.","['Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia', 'children with hypoxemia', 'children hospitalized with acute hypoxemic respiratory illness', 'Children aged <\u20095\u2009years hospitalized with hypoxemia (saturation\u2009<\u200992%) warranting hospital admission based on clinical judgement', 'children hospitalized with acute hypoxemic respiratory illness across Uganda', 'Study procedure: Patients receive standard of care within pediatric wards with or without SPO 2 system installed', '2400 patients across 20 health facilities', 'Objectives']","['Solar-powered oxygen delivery', 'SPO', 'continuous oxygen therapy']","['safety, efficacy, SPO 2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration', 'calendar time (fixed effect) and site (random effect', 'mortality', '48-h mortality']","[{'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]","[{'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2400.0,0.482126,"Secondary: safety, efficacy, SPO 2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Conradi', 'Affiliation': 'Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Qaasim', 'Initials': 'Q', 'LastName': 'Mian', 'Affiliation': 'Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Namasopo', 'Affiliation': 'Kabale Regional Referral Hospital, Kabale, Uganda.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Conroy', 'Affiliation': 'Indiana University, Indianapolis, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hermann', 'Affiliation': 'Kelowna General Hospital, Kelowna, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Olaro', 'Affiliation': 'Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Amone', 'Affiliation': 'Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics and Child Health, Mulago Hospital and Makerere University, Kampala, Uganda.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Hawkes', 'Affiliation': 'Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada. mthawkes@ualberta.ca.'}]",Trials,['10.1186/s13063-019-3752-2'] 892,31625947,A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis.,"BACKGROUND A self-administered Web-based intervention was developed to help carers of persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC) deal with the significant transitions they experience. The intervention, My Tools 4 Care (MT4C), was evaluated during a pragmatic mixed methods randomized controlled trial with 199 carers. Those in the intervention group received free, password-protected access to MT4C for three months. MT4C was found to increase hope in participants at three months compared with the control group. However, in the intervention group, 22% (20/92) did not use MT4C at all during the three-month period. OBJECTIVE This mixed methods secondary analysis aimed to (1) examine differences at three months in the outcomes of hope, self-efficacy, and health-related quality of life (HRQOL) scores in users (ie, those who used MT4C at least once during the three-month period) compared with nonusers and (2) identify reasons for nonuse. METHODS Data from the treatment group of a pragmatic mixed methods randomized controlled trial were used. Through audiotaped telephone interviews, trained research assistants collected data on participants' hope (Herth Hope Index; HHI), self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL (Short-Form 12-item health survey version 2; SF-12v2) at baseline, one month, and three months. Treatment group participants also provided feedback on MT4C through qualitative telephone interviews at one month and three months. Analysis of covariance was used to determine differences at three months, and generalized estimating equations were used to determine significant differences in HHI, GSES, and SF-12v2 between users and nonusers of MT4C from baseline to three months. Interview data were analyzed using content analysis and integrated with quantitative data at the result stage. RESULTS Of the 101 participants at baseline, 9 (9%) withdrew from the study, leaving 92 participants at three months of which 72 (78%) used MT4C at least once; 20 (22%) participants did not use it at all. At baseline, there were no statistically significant differences in demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score) between users and nonusers. At three months, participants who used MT4C at least once during the three-month period (users) reported higher mean GSES scores (P=.003) than nonusers. Over time, users had significantly higher GSES scores than nonusers (P=.048). Reasons for nonuse of MT4C included the following: caregiving demands, problems accessing MT4C (poor connectivity, computer literacy, and navigation of MT4C), and preferences (for paper format or face-to-face interaction). CONCLUSIONS Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC. Future research with MT4C should consider including educational programs for computer literacy and providing alternate ways to access MT4C in addition to Web-based access. TRIAL REGISTRATION ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387.",2019,"CONCLUSIONS Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC.","['users', 'Carers of Older Persons With Alzheimer Disease and Related Dementias', 'persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC']","['MT4C', 'Web-Based Intervention']","['hope, self-efficacy, and health-related quality of life (HRQOL) scores', 'GSES scores', 'self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL ', 'demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score', 'mean GSES scores', 'HHI, GSES, and SF-12v2']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",101.0,0.122176,"CONCLUSIONS Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Duggleby', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'McAiney', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kathya', 'Initials': 'K', 'LastName': 'Jovel Ruiz', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Cancer Care, Alberta Health Services, Edmonton, AB, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'School of Geography and Earth Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Triscott', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swindle', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}]",Journal of medical Internet research,['10.2196/14254'] 893,31888928,Safety of switching from vitamin K antagonist to non-vitamin K antagonist oral anticoagulant in frail elderly with atrial fibrillation: rationale and design of the FRAIL-AF randomised controlled trial.,"INTRODUCTION Clinical guidelines recommend non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) for stroke prevention in most patients with atrial fibrillation (AF). Frail elderly were under-represented in the landmark NOAC-trials, leaving a knowledge gap on the optimal anticoagulant management (VKA or NOAC) in this increasing population. The aim of the Frail-AF (FRAIL-AF) study is to assess whether switching from international normalised ratio (INR)-guided VKA-management to a NOAC-based treatment strategy compared with continuing VKA-management is safe in frail elderly patients with AF. METHODS AND ANALYSIS The FRAIL-AF study is a pragmatic, multicentre, open-label, randomised controlled clinical trial. Frail elderly (age ≥75 years plus a Groningen Frailty Indicator score ≥3) who receive VKA-treatment for AF in the absence of a mechanical heart valve or severe mitral valve stenosis will be randomised to switch to a NOAC-based treatment strategy or to continue INR-guided VKA-management. Patients with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m 2 ) will be excluded from randomisation. Based on existing trial evidence in non-frail patients, we will aim to explore whether NOAC-treatment is superior to VKA-therapy in reducing major or clinically relevant non-major bleeding events. Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness. The follow-up period for all subjects is 12 months. ETHICS AND DISSEMINATION The protocol was approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands and by the Central Committee on Research Involving Human Subjects, the Netherlands. All patients are asked written informed consent. Results are expected in 2022 and will be disseminated through peer-reviewed journals as well as presentations at national and international conferences. TRIAL REGISTRATION NUMBER EudraCT: 2017-000393-11; The Netherlands Trial Registry: 6721 (FRAIL-AF study).",2019,"Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness.","['Frail elderly', 'frail elderly with atrial fibrillation', 'Frail elderly (age ≥75 years plus a Groningen Frailty Indicator score ≥3) who receive VKA-treatment for AF in the absence of a mechanical heart valve or severe mitral valve stenosis', 'patients with atrial fibrillation (AF', '2017-000393-11', 'Patients with severe renal impairment (estimated glomerular filtration rate', 'frail elderly patients with AF', 'Frail-AF (FRAIL-AF', 'non-frail patients']","['anticoagulant management (VKA or NOAC', 'switching from vitamin K antagonist', 'NOAC-based treatment strategy or to continue INR-guided VKA-management', 'vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs', 'VKA-management', 'vitamin K antagonist oral anticoagulant']","['minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness']","[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4075877', 'cui_str': 'Groningen Frailty Indicator score'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026269', 'cui_str': 'Mitral Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C3811844'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0642228', 'cui_str': 'NOAC'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.097323,"Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness.","[{'ForeName': 'Linda P T', 'Initials': 'LPT', 'LastName': 'Joosten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands l.p.t.joosten-3@umcutrecht.nl.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'van Doorn', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Melchior C', 'Initials': 'MC', 'LastName': 'Nierman', 'Affiliation': 'Department of Thrombosis and Anticoagulation, Atalmedial Medical Diagnostics Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Nynke M', 'Initials': 'NM', 'LastName': 'Wiersma', 'Affiliation': 'Department of Thrombosis and Anticoagulation, Diagnostic Center Saltro, Utrecht, The Netherlands.'}, {'ForeName': 'Huiberdina L', 'Initials': 'HL', 'LastName': 'Koek', 'Affiliation': 'Department of Geriatrics, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Martin E W', 'Initials': 'MEW', 'LastName': 'Hemels', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rutger M', 'Initials': 'RM', 'LastName': 'van den Bor', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wim F', 'Initials': 'WF', 'LastName': 'Buding', 'Affiliation': 'Member of the Dutch Organisation for patients using anticoagulant medication, CTD Nederland, Leiden, The Netherlands.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-032488'] 894,31857313,Comparison between electronic and paper versions of patient-reported outcome measures in subjects with chronic obstructive pulmonary disease: an observational study with a cross-over administration.,"OBJECTIVES A wide range of electronic devices can be used for data collection of patient-reported outcome (PRO) measures in subjects with chronic obstructive pulmonary disease (COPD). Although comparisons between electronic and paper-based PRO measures have been undertaken in asthmatics, it is currently uncertain whether electronic questionnaires work equally as well as paper versions in elderly subjects with COPD. The aim of this study was to compare the responses to paper and electronic versions of the Evaluating Respiratory Symptoms in COPD (E-RS) and the COPD Assessment Test (CAT). DESIGN A randomised cross-over design was used to compare the responses to paper and electronic versions of the two tools. The interval between the two administrations was 1 week. SETTING Electronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail. It was intended that half of the patients completed the electronic versions of both questionnaires first, followed by the paper versions while the other half completed the paper versions first. PARTICIPANTS Eighty-one subjects with stable COPD were included. RESULTS The E-RS total scores (possible range 0-40) were 6.8±7.4 and 5.0±6.6 in the paper-based and electronic versions, respectively, and the CAT scores (possible range 0-40) were 10.0±7.4 and 8.6±7.8. In both questionnaires, higher scores indicate worse status. The relationship between electronic and paper versions showed significant reliability for both the E-RS total score and CAT score (intraclass correlation coefficient=0.82 and 0.89, respectively; both p<0.001). However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05). CONCLUSIONS In both cases, the two versions of the same questionnaire cannot be used interchangeably even though they have both been validated.",2019,"However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05). ","['Electronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail', 'Eighty-one subjects with stable COPD were included', 'subjects with chronic obstructive pulmonary disease', 'subjects with chronic obstructive pulmonary disease (COPD', 'elderly subjects with COPD']",[],"['E-RS total and CAT scores', 'E-RS total scores', 'CAT scores', 'E-RS total score and CAT score (intraclass correlation', 'COPD Assessment Test (CAT']","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}]",81.0,0.0313509,"However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05). ","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan koichi-nishimura@nifty.com.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kusunose', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sanda', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Hoshi Iryo-Sanki Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Oga', 'Affiliation': 'Department of Respiratory Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-032767'] 895,31854292,Sexual health promotion in people with severe mental illness: the RESPECT feasibility RCT.,"BACKGROUND People with serious mental illness have sexual health needs, but there is limited evidence regarding effective interventions to promote their sexual health. OBJECTIVES To develop a sexual health promotion intervention for people with serious mental illness, and to conduct a feasibility trial in order to establish the acceptability and parameters for a fully powered trial. DESIGN A two-armed randomised controlled, open feasibility study comparing usual care alone with usual care plus the adjunctive intervention. SETTING Five community mental health providers in Leeds, Barnsley, Brighton and London. PARTICIPANTS Adults aged ≥ 18 years with serious mental illness and receiving care from community mental health teams. INTERVENTIONS A remote, web-based computer randomisation system allocated participants to usual care plus the RESPECT (Randomised Evaluation of Sexual health Promotion Effectiveness informing Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm). The intervention was an interactive manualised package of exercises, quizzes and discussion topics focusing on knowledge, motivation and behavioural intentions to adopt safer sexual behaviours. MAIN OUTCOME MEASURES Feasibility parameters including establishing the percentage of people who were eligible, consented and were retained in each arm of the trial, retention for the intervention, as well as the completeness of the data collection. Data were collected on knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life. Data were collected at baseline and then at 3 months and 6 months post randomisation. RESULTS Of a target of 100 participants, 72 people participated in the trial over 12 months. Of the 36 participants randomised to the intervention arm, 27 received some of the intervention (75.0%). At 3 months, 59 of the 72 participants completed follow-up questionnaires (81.9%) (30 participants from the intervention arm and 29 participants from the control arm). Only the first 38 participants were followed up at 6 months. However, data were collected on 29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm. No adverse events were reported. Participant feedback confirmed that both the design and the intervention were acceptable. The economic analysis indicated high completion rates and completeness of data among participants who continued the trial. CONCLUSIONS Despite the limitations, the findings suggest that it is both acceptable and feasible to undertake a sexual health promotion study for people with serious mental illness. FUTURE WORK A fully powered randomised controlled trial would be required to establish the clinical effectiveness of the intervention. TRIAL REGISTRATION Current Controlled Trials ISRCTN15747739. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 65. See the NIHR Journals Library website for further project information.",2019,No adverse events were reported.,"['29 out of 38 participants (76.3% retention): 13 in the intervention arm and 16 in the control arm', 'Adults aged ≥\u200918 years with serious mental illness and receiving care from community mental health teams', 'people with serious mental illness', 'Five community mental health providers in Leeds, Barnsley, Brighton and London', '72 people participated in the trial over 12 months', 'people with severe mental illness', '100 participants', 'People with serious mental illness']","['sexual health promotion intervention', 'usual care alone with usual care plus the adjunctive intervention', 'Care and Treatment) intervention (three sessions of 1 hour) (intervention arm) or usual care only (control arm']","['Sexual health promotion', 'adverse events', 'knowledge, motivation to adopt safer sexual behaviour, sexual behaviour, sexual stigma, sexual health service use and quality of life']","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",100.0,0.130031,No adverse events were reported.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Thirimon', 'Initials': 'T', 'LastName': 'Moe-Byrne', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Edmondson', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Lottie', 'Initials': 'L', 'LastName': 'Millett', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Dare', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, University of Sussex, Brighton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'Expert by experience, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23650'] 896,31884945,Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial.,"BACKGROUND Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home. METHODS This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state. DISCUSSION The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process. TRIAL REGISTRATION ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.",2019,Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF.,"['advanced heart failure patients and their family caregivers in rural appalachia', 'Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers', 'patients and family members managing home supportive EOLPC for advanced HF']","['intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions', 'coaching end-of-life palliative care', 'routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses', 'FamPALcare nursing care intervention', 'FamPALcare intervention']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]",[],,0.100585,Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF.,"[{'ForeName': 'Ubolrat', 'Initials': 'U', 'LastName': 'Piamjariyakul', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA. ubolrat.piamjariyakul@hsc.wvu.edu.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Petitte', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Smothers', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics School of Public Health, West Virginia University, Morgantown, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'West Virginia University, School of Nursing Health Sciences Center, Post Office Box 9600 - Office 6701, Morgantown, WV, 26506-9602, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sokos', 'Affiliation': 'Advanced Heart Failure, West Virginia University Heart and Vascular Institute, J.W. Ruby Memorial Hospital, Morgantown, USA.'}, {'ForeName': 'Alvin H', 'Initials': 'AH', 'LastName': 'Moss', 'Affiliation': 'Sections of Nephrology and Supportive Care, West Virginia University Center for Health Ethics and Law, Morgantown, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Smith', 'Affiliation': 'University of Kansas Medical Center, School of Nursing and School of Preventive Medicine, Morgantown, USA.'}]",BMC palliative care,['10.1186/s12904-019-0500-z'] 897,31879033,"The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device.","PURPOSE The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has produced significant reductions in LDL-C at a dose of 300 mg q4w administered as 2 separate 150-mg injections via a 1-mL autoinjector (AI). A recently developed 2-mL device (SYDNEY) permits the administration of a single 300mg dose of alirocumab. METHODS We assessed the usability and product technical complaints (PTCs) reported by patients using the 2-mL SYDNEY device in unsupervised settings, adverse events, and effects on LDL-C, in a multicenter, randomized, open-label, 16-week study conducted in the United States. For their first dose, 69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received supervised, self-administered alirocumab 300 mg via 1 × 300 mg injection with the SYDNEY device (n = 35) or 2 × 150-mg injections with the currently approved AI (n = 34). All continuing patients subsequently received unsupervised, self-administered alirocumab 300 mg q4w using the SYDNEY device at weeks 4, 8, and 12. The primary end point was the proportion of SYDNEY device-associated PTCs related to the use of the unsupervised injections. FINDINGS Baseline characteristics between the study arms varied only in a higher percentage of males being randomized to the study arm using the SYDNEY device (74.3%) compared with the AI arm (44.1%). A single PTC was reported during the unsupervised injections (0.5%; 1 of 196 injections; 95% CI, 0.0%-3.2%). This event was classified as patient related as opposed to device related. No PTCs occurred during supervised injections. Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively. LDL-C reductions persisted for 16 weeks. The most common adverse event was upper respiratory tract infection (3 with SYDNEY and 0 with the AI during weeks 0-4). IMPLICATIONS The SYDNEY device allowed for a single 2-mL injection of alirocumab 300 mg, providing substantial LDL-C reductions with no new product technical issues or no new safety concerns compared with the currently marketed 1-mL AI device. In conclusion, the 2-mL SYDNEY device provides patients with the possibility of injecting the 300-mg alirocumab dose as a single injection. ClinicalTrials.gov identifier: NCT03415178.",2020,"Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively.",['69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received'],"['300\xa0mg via 1\xa0×', 'supervised, self-administered alirocumab', 'alirocumab', 'XX:XXX-XXX', '2-mL Alirocumab Autoinjector Device']","['usability and product technical complaints (PTCs', 'LDL-C reductions', 'Mean LDL-C reductions', 'mean LDL-C reductions', 'proportion of SYDNEY device-associated PTCs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",69.0,0.138074,"Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively.","[{'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, United States. Electronic address: juan.frias@nritrials.com.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center For Clinical Research, Jacksonville, FL, United States.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Loizeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Merino-Trigo', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States.'}, {'ForeName': 'Mary Alice', 'Initials': 'MA', 'LastName': 'Raudenbush', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Batsu', 'Affiliation': 'Sanofi, Bridgewater, NJ, United States.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.008'] 898,31556667,Opioid use before and after completion of an online pain management program.,"OBJECTIVE The purpose of this study was to examine the effect of a pain management course that has demonstrated efficacy in pain reduction on the use of opioid medication. METHOD Self-reported medication use was recorded at baseline assessment for all patients enrolled in a validated pain management program provided free by a university research clinic (N = 471). Participants were randomized either to receive immediate treatment or to be a wait-list control. Opioid use at baseline assessment, with the daily doses converted to morphine equivalents, was compared with the self-reported opioid medication use at posttreatment and 3-month follow-up. The relationship between opioid use and measures of psychological symptoms, pain, and disability was examined. RESULTS At assessment, 85% (n = 399) reported taking some form of pain modifying or psychotropic medication, 43.1% (n = 203) reported regular opioid use and 22.9% (n = 108) reported taking additional as required (pro re nata, or PRN) opioid-containing medication. On completion, there were significant reductions in the number who reported taking regular opioids and a large reduction in the use of PRN opioids and in the reported doses of opioids. Those reductions were more strongly associated with reductions in symptoms of anxiety and depression than in measures of disability and pain. CONCLUSIONS The reduction in the self-reported use of regular and PRN opioid pain-relieving medication following completion of an online pain management program with demonstrated efficacy in pain reduction appeared to be related to effective treatment of symptoms of anxiety and depression. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,The reduction in the self-reported use of regular and PRN opioid pain-relieving medication following completion of an online pain management program with demonstrated efficacy in pain reduction appeared to be related to effective treatment of symptoms of anxiety and depression.,['patients enrolled in a validated pain management program provided free by a university research clinic (N = 471'],['immediate treatment or to be a wait-list control'],"['symptoms of anxiety and depression', 'disability and pain', 'psychological symptoms, pain, and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",2019.0,0.0235689,The reduction in the self-reported use of regular and PRN opioid pain-relieving medication following completion of an online pain management program with demonstrated efficacy in pain reduction appeared to be related to effective treatment of symptoms of anxiety and depression.,"[{'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Nielssen', 'Affiliation': 'MindSpot Clinic, Macquarie University.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'Department of Psychology, eCentreClinic, Macquarie University.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Staples', 'Affiliation': 'MindSpot Clinic and Department of Psychology, eCentreClinic, Macquarie University.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'MindSpot Clinic and Department of Psychology, eCentreClinic, Macquarie University.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'Department of Psychology, eCentreClinic, Macquarie University.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Fogliati', 'Affiliation': 'Department of Psychology, eCentreClinic, Macquarie University.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'MindSpot Clinic, Macquarie University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000407'] 899,31838334,"How does Community-Led Total Sanitation (CLTS) promote latrine construction, and can it be improved? A cluster-randomized controlled trial in Ghana.","RATIONALE Open defecation is connected to poor health and child mortality, but billions of people still do not have access to safe sanitation facilities. Community-Led Total Sanitation (CLTS) promotes latrine construction to eradicate open defecation. However, the mechanisms by which CLTS works and how they can be improved remain unknown. The present study is the first to investigate the psychosocial determinants of CLTS in a longitudinal design. Furthermore, we tested whether CLTS can be made more effective by theory- and evidence-based interventions using the risks, attitudes, norms, abilities, and selfregulation (RANAS) model. METHODS A cluster-randomized controlled trial of 3216 households was implemented in rural Ghana. Communities were randomly assigned to classic CLTS, one of three RANAS-based interventions, or to the control arm. Prepost surveys at 6-month follow-up included standardized interviews assessing psychosocial determinants from the RANAS model. Regression analyses and multilevel mediation models were computed to test intervention effects and mechanisms of CLTS. RESULTS Latrine coverage increased pre-post by 67.6% in all intervention arms and by 7.9% in the control arm (p < .001). The combination with RANAS-based interventions showed non-significantly greater effects than CLTS alone. The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment. Changes in vulnerability, severity, and barrier planning were positively connected to latrine construction but not affected by CLTS. CONCLUSION This study corroborates the effectiveness of CLTS in increasing latrine coverage, and additional activities can be improved further. Behaviour change techniques within CLTS that strengthened the relevant factors should be maintained. The study also recommends interventions based on the RANAS approach to improve CLTS. Further research is needed to understand the effects of RANAS-based interventions combined with CLTS at longer follow-up.",2020,"The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment.","['3216 households was implemented in rural Ghana', 'Ghana']","['Community-Led Total Sanitation (CLTS', 'CLTS']","['latrine construction', 'vulnerability, severity, and barrier planning']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}]","[{'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",,0.0327357,"The effects of CLTS on latrine construction were significantly mediated by changes in four determinants: others' behaviour and approval, self-efficacy, action planning and commitment.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Harter', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland. Electronic address: miriam.harter@eawag.ch.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Inauen', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland; Department of Psychology, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland. Electronic address: jennifer.inauen@eawag.ch.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Ueberlandstrasse 133, 8600, Dübendorf, Switzerland. Electronic address: hans-joachim.mosler@eawag.ch.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.112705'] 900,31992459,Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State.,"PURPOSE Coadministration of lobeglitazone and dapagliflozin is expected to result in a blood glucose-lowering effect, followed by a gradual increase, in clinical usage; however, combining drugs could cause negative interactions. This study aimed to evaluate the effect of the coadministration of lobeglitazone and dapagliflozin on their individual pharmacokinetic properties at steady state in healthy male volunteers in the fasted state. METHODS This study consisted of 2 parts, each of which was a randomized, open-labeled, multiple-dose, 2-way crossover study in 20 healthy male volunteers in each part. Blood samples were taken periodically over a 48-h period after dosing to derive total plasma lobeglitazone and dapagliflozin pharmacokinetic properties; safety profile was evaluated throughout the study. FINDINGS When the pharmacokinetic properties of dapagliflozin were evaluated following its administration alone and in combination with lobeglitazone, point estimate and 90% CI of the geometric mean ratio of dapagliflozin AUC τ were entirely within the conventional bioequivalence range of 80%-125%. However, although it was not clinically meaningful, its C ss,max was ~8% lower in subjects receiving multiple doses of dapagliflozin and lobeglitazone than that in those administered dapagliflozin alone. The pharmacokinetic properties of lobeglitazone were evaluated following its administration alone and in combination with dapagliflozin. The geometric mean ratios and 90% CIs of the lobeglitazone C ss,max and AUC τ were within the conventional bioequivalence range of 80%-125%. IMPLICATIONS Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug. Based on these findings, it is anticipated that lobeglitazone and dapagliflozin can be coadministered without dose adjustment. ClinicalTrials.gov identifier: NCT03616392.",2020,"IMPLICATIONS Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug.","['20 healthy male volunteers in each part', 'healthy male volunteers in the fasted state']","['lobeglitazone', 'dapagliflozin and lobeglitazone', 'lobeglitazone and dapagliflozin', 'dapagliflozin']","['geometric mean ratios and 90% CIs of the lobeglitazone C ss,max and AUC τ']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",20.0,0.0306666,"IMPLICATIONS Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug.","[{'ForeName': 'Kyungho', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: khjang@jbcp.kr.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: jyjeon@jbcp.kr.'}, {'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea. Electronic address: sjmoon@jbcp.kr.'}, {'ForeName': 'Min-Gul', 'Initials': 'MG', 'LastName': 'Kim', 'Affiliation': 'Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, South Korea; Research Institute of Clinical Medicine of Chonbuk National University, Jeonju, South Korea; Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, South Korea. Electronic address: mgkim@jbnu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.01.003'] 901,31332603,A Randomized Trial of Ultrasound- versus. Fluoroscopy-Guided Subclavian Vein Catheterization in Children with Hematologic Disease.,"OBJECTIVE To compare the ultrasound- and fluoroscopy-guided subclavian vein catheterization in pediatric population with hematologic diseases. METHODS A randomized prospective study of subclavian vein catheterization in pediatric population with hematologic diseases was performed. After randomization, the patients were assigned to either ultrasound- or fluoroscopy-guided subclavian vein catheterization. The primary outcome was number of attempts at venous cannulation. Secondary outcomes included: catheterization success rate, fluoroscopy time, operation time, and surgical complications. RESULTS There were 170 children enrolled between February 2017 and July 2018. There was no difference between the two groups with regard to the demographic data. Success within 3 attempts was achieved in 82 cases (82/87, 92.0%) in the ultrasound (US) group vs. 65 cases (65/83, 78.3%) in the fluoroscopy group (P = 0.002). The average operation time was 10(7) min in US group vs. 10(6) min in fluoroscopy group (P = 0.722). There were 3 complications in the US group, while there were 6 complications in the fluoroscopy group (P = 0.321). There were 4 catheter-related thrombosis (CRTs) found in the US group during follow-up, however there was no CRT in the fluoroscopy group (P = 0.121). CONCLUSIONS Ultrasound-guided venous puncture is a more accurate method of subclavian vein catheterization. However, the catheter tip can be placed more precisely by fluoroscopy. Thus, combined ultrasound-and fluoroscopy-guided technology is more efficient in subclavian vein catheterization of children with hematologic disease.",2019,The average operation time was 10(7) min in US group vs. 10(6) min in fluoroscopy group (P = 0.722).,"['pediatric population with hematologic diseases', 'children with hematologic disease', '170 children enrolled between February 2017 and July 2018', 'Children with Hematologic Disease']","['Ultrasound-guided venous puncture', 'ultrasound- and fluoroscopy-guided subclavian vein catheterization', 'ultrasound- or fluoroscopy-guided subclavian vein catheterization', 'Fluoroscopy-Guided Subclavian Vein Catheterization', 'combined ultrasound-and fluoroscopy-guided technology', 'subclavian vein catheterization', 'Ultrasound']","['number of attempts at venous cannulation', 'catheter-related thrombosis (CRTs', 'catheterization success rate, fluoroscopy time, operation time, and surgical complications', 'average operation time']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018939', 'cui_str': 'Blood Diseases'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0340778', 'cui_str': 'Venous puncture (disorder)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0038532', 'cui_str': 'Subclavian Vein'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C4087547', 'cui_str': 'Catheter related thrombosis'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",170.0,0.0276912,The average operation time was 10(7) min in US group vs. 10(6) min in fluoroscopy group (P = 0.722).,"[{'ForeName': 'Huajin', 'Initials': 'H', 'LastName': 'Pang', 'Affiliation': 'Department of Interventional Radiology, Nanfang Hospital, Southern Medical University, Guangzhou, China. nfyyphj@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Interventional Radiology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xuehan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Interventional Radiology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weizhen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Ultrasound, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Ultrasound, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]",Indian journal of pediatrics,['10.1007/s12098-019-03021-3'] 902,32197640,"Tongmai Yangxin intervening in myocardial remodeling after PCI for coronary heart disease: study protocol for a double-blind, randomized controlled trial.","BACKGROUND Coronary heart disease (CHD) has become a common cardiovascular disease that seriously threatens the health of people. As reperfusion in the early phase and drug therapy, especially percutaneous coronary intervention (PCI), have become widely used in the clinic, the mortality of acute myocardial infarction in the short term has been reduced significantly. In addition, in 40%-56% of patients who experience myocardial infarction, cardiac dysfunction occurs and about 25%-33% develop heart failure. METHODS This study was designed as a multicenter, double-blind, randomized, placebo-controlled, parallel-group, superiority trial. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. The primary outcome was left ventricular end-diastolic volume index = left ventricular end-diastolic volume/body surface area. The combined secondary outcomes include traditional Chinese medicine syndrome score, echocardiogram results, 6-minute walk test results, Seattle Angina Questionnaire score, cardiac magnetic resonance imaging results, biological indicators, dynamic electrocardiogram results, and experiment event rate. Assessments will be performed at baseline and at 4, 8, and 12 weeks after randomization. DISCUSSION This trial will demonstrate that the addition of a Tongmai Yangxin pill (TMYX) to conventional treatment will intervene in the development of cardiac remodeling and cardiac dysfunction. TRIAL REGISTRATION This study was registered in the Chinese Clinical Trial Registry on 7 May 2019. The registration number is ChiCRT1900023023 (http://www.chictr.org.cn/showproj.aspx?proj=12370).",2020,"This trial will demonstrate that the addition of a Tongmai Yangxin pill (TMYX) to conventional treatment will intervene in the development of cardiac remodeling and cardiac dysfunction. ",[],"['percutaneous coronary intervention (PCI', 'Tongmai Yangxin pill (TMYX', 'placebo', 'Tongmai Yangxin']","['traditional Chinese medicine syndrome score, echocardiogram results, 6-minute walk test results, Seattle Angina Questionnaire score, cardiac magnetic resonance imaging results, biological indicators, dynamic electrocardiogram results, and experiment event rate', 'left ventricular end-diastolic volume index\u2009=\u2009left ventricular end-diastolic volume/body surface area']",[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4505187', 'cui_str': 'Biological Indicator'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455833', 'cui_str': 'Left ventricular end diastolic volume'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]",,0.689104,"This trial will demonstrate that the addition of a Tongmai Yangxin pill (TMYX) to conventional treatment will intervene in the development of cardiac remodeling and cardiac dysfunction. ","[{'ForeName': 'Yongxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Xinlu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Jianru', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Graduate Division, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Yucai', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Xingyuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Guangcao', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China.'}, {'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Henan University of Chinese Medicine, 156 Jinshui East Road, Zhengdong New District, Zhengzhou, 450046, Henan Province, China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Center of Cardiology, The First Affiliated Hospital of Henan University of TCM, 19 Renmin Road, Jinshui District, Zhengzhou, 450100, Henan Province, China. zhumingjun317@163.com.'}]",Trials,['10.1186/s13063-020-4208-4'] 903,31333114,Comparison of the Quality of Life of Cancer Patients with Pain Treated with Oral Controlled-Release Morphine and Oxycodone and Transdermal Buprenorphine and Fentanyl.,"AIM To compare the effects of oral morphine and oxycodone and transdermal fentanyl and buprenorphine on quality of life (QoL) of cancer patients with severe pain. PATIENTS AND METHODS Cancer patients with severe pain (NRS 6-10) treated at home and in outpatient clinics who failed to respond to non-opioids and/or ""weak"" opioids were randomized to morphine, oxycodone, fentanyl, or buprenorphine treatment for 28 days. Immediate-release oral morphine was rescued analgesic and 10-ml lactulose twice daily was prophylaxis of constipation; no antiemetics were used for prophylaxis. RESULTS Above all, 62 patients participated and 53 patients completed the study. Good analgesia was obtained with all 4 opioids. Morphine was associated with the less negative impact of pain on the ability to walk and normal work, and tendency on activity (BPI-SF) and lower consumption of rescue morphine. All 4 opioids elicited similar adverse effects. According to ESAS, the intensity of nausea and drowsiness increased at the beginning but decreased as treatment continued. Appetite, well-being, anxiety, depression, and fatigue improved. No changes were seen in constipation, vomiting and dyspnea. Constipation was rarely observed with all opioids (BFI). Any opioids improved overall QoL and emotional functioning with tendency improving physical functioning (EORTC QLQ-C15-PAL). Activity improved (Karnofsky). Morphine induced greater improvement in physical functioning and trend in improvement mood (HADS). CONCLUSION All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.",2019,All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.,"['cancer patients with severe pain', 'cancer patients with pain treated with oral controlled-release', '62 patients participated and 53 patients completed the study', 'Cancer patients with severe pain (NRS 6-10) treated at home and in outpatient clinics who failed to respond to non-opioids and/or ""weak"" opioids']","['morphine and oxycodone and transdermal fentanyl and buprenorphine', 'morphine and oxycodone and transdermal buprenorphine and fentanyl', 'morphine', 'morphine, oxycodone, fentanyl, or buprenorphine', 'Morphine']","['Constipation', 'nausea and drowsiness', 'overall QoL and emotional functioning', 'physical functioning', 'quality of life (QoL', 'Good analgesia', 'negative impact of pain on ability to walk and normal work, and tendency on activity (BPI-SF) and lower consumption of rescue morphine', 'Appetite, well-being, anxiety, depression, and fatigue improved', 'Activity improved (Karnofsky', 'improvement mood (HADS', 'adverse effects', 'constipation, vomiting and dyspnea']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",62.0,0.034576,All opioids significantly improved patients' QoL. Morphine induced less negative impact of pain on daily activities and greater improvement in physical functioning with trends of better mood and less intense fatigue.,"[{'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Leppert', 'Affiliation': 'Laboratory of Quality of Life Research, Chair and Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Nosek', 'Affiliation': 'Non-public Saint Lazarius Health Care Unit, Biskupiec, Poland.'}]",Current pharmaceutical design,['10.2174/1381612825666190717091230'] 904,32108976,Improving Cancer Patients' Insurance Choices (I Can PIC): A Randomized Trial of a Personalized Health Insurance Decision Aid.,"BACKGROUND Many cancer survivors struggle to choose a health insurance plan that meets their needs because of high costs, limited health insurance literacy, and lack of decision support. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. MATERIALS AND METHODS Eligible individuals (18-64 years, diagnosed with cancer for ≤5 years, English-speaking, not Medicaid or Medicare eligible) were randomized to I Can PIC or an attention control health insurance worksheet. Primary outcomes included health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control. Secondary outcomes included knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up. RESULTS A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up. After viewing I Can PIC or the control, health insurance knowledge and a health insurance literacy item assessing confidence understanding health insurance were higher in the I Can PIC group. At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed. There were no significant differences between groups in other outcomes. Results did not change when controlling for health literacy and employment. Both groups reported having limited health insurance options. CONCLUSION I Can PIC can improve cancer survivors' health insurance knowledge and confidence using health insurance. System-level interventions are needed to lower financial toxicity and help patients manage care costs. IMPLICATIONS FOR PRACTICE Inadequate health insurance compromises cancer treatment and impacts overall and cancer-specific mortality. Uninsured or underinsured survivors report fewer recommended cancer screenings and may delay or avoid needed follow-up cancer care because of costs. Even those with adequate insurance report difficulty managing care costs. Health insurance decision support and resources to help manage care costs are thus paramount to cancer survivors' health and care management. We developed a web-based decision aid, Improving Cancer Patients' Insurance Choices (I Can PIC), and evaluated it in a randomized trial. I Can PIC provides health insurance information, supports patients through managing care costs, offers a list of financial and emotional support resources, and provides a personalized cost estimate of annual health care expenses across plan types.",2020,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","['A total of 263 of 335 eligible participants (79%) consented and were randomized; 206 (73%) completed the initial survey (106 in I Can PIC; 100 in the control), and 180 (87%) completed a 3-6 month follow-up', ""Cancer Patients' Insurance Choices (I Can PIC"", 'Eligible individuals (18-64\u2009years, diagnosed with cancer for ≤5\u2009years, English-speaking, not Medicaid or Medicare eligible']",['I Can PIC or an attention control health insurance worksheet'],"['health literacy and employment', 'health insurance knowledge, decisional conflict, and decision self-efficacy after completing I Can PIC or the control', 'knowledge, decisional conflict, decision self-efficacy, health insurance literacy, financial toxicity, and delayed care at a 3-6-month follow-up']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]","[{'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0730321', 'cui_str': 'Punctate inner choroiditis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",335.0,0.111716,"At follow-up, the I Can PIC group retained higher knowledge than the control; confidence understanding health insurance was not reassessed.","[{'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Grant', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Nerissa P', 'Initials': 'NP', 'LastName': 'George', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Barker', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Aimee S', 'Initials': 'AS', 'LastName': 'James', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Kuroki', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'McBride', 'Affiliation': 'Brown School and Center for Health Economics and Policy, Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Goodwin', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0703'] 905,32492041,Corrected analysis of 'Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial' confirms conclusions.,,2020,,['American Indian adolescents'],[],[],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.100604,,"[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Xiwei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dickinson', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Short', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Indiana, United States of America.'}]",PloS one,['10.1371/journal.pone.0233273'] 906,32114310,Acute and long-term effects of electroacupuncture alter frontal and insular cortex activity and functional connectivity during resting state.,"Electroacupuncture (EA) is a safe method for treating obesity; however, its underlying neural mechanisms remain unclear. We employed resting-state-functional-magnetic-resonance-imaging (RS-fMRI) and amplitude-of-low-frequency-fluctuation (ALFF) to investigate acute/long-term effects of EA on brain activity and resting-state-functional-connectivity (RSFC) in overweight/obesity subjects who received real/Sham stimulation. For acute effects, 26 and 19 overweight/obesity subjects were included in EA and Sham groups respectively. There were significant time effects on ALFF in the right insula (INS) and left dorsolateral-prefrontal-cortex (DLPFC) due to decreases/increases in INS/DLPFC in both groups. There were weaker positive RSFC between INS and supplementary-motor-area (SMA)/right DLPFC and weaker negative RSFC between INS and precuneus (PCUN); stronger negative RSFC between DLPFC and dorsomedial-prefrontal-cortex (DMPFC) in both groups. For long-term study, body-mass-index (BMI) had significant reduction in EA (n = 17) and Sham (15) groups; EA had higher BMI reduction than in Sham. There were significant time effects on ALFF in right ventrolateral-prefrontal-cortex (VLPFC) due to significant increases in EA group, and stronger positive RSFC between VLPFC and orbitofrontal-cortex and negative RSFC between VLPFC and left thalamus (THA) in both groups after long-term treatment. These findings suggest that changes in resting-activity and RSFC implicated in inhibitory-control, gastric-motility and satiety-control are associated with EA-induced weight-loss.",2020,There were significant time effects on ALFF in the right insula (INS) and left dorsolateral-prefrontal-cortex (DLPFC) due to decreases/increases in INS/DLPFC in both groups.,"['overweight/obesity subjects who received real/Sham stimulation', '26 and 19 overweight/obesity subjects']","['Electroacupuncture (EA', 'EA', 'resting-state-functional-magnetic-resonance-imaging (RS-fMRI) and amplitude-of-low-frequency-fluctuation (ALFF', 'electroacupuncture']","['BMI reduction', 'INS/DLPFC', 'ALFF in the right insula (INS) and left dorsolateral-prefrontal-cortex (DLPFC', 'ALFF in right ventrolateral-prefrontal-cortex (VLPFC', 'brain activity and resting-state-functional-connectivity (RSFC']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0383794,There were significant time effects on ALFF in the right insula (INS) and left dorsolateral-prefrontal-cortex (DLPFC) due to decreases/increases in INS/DLPFC in both groups.,"[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': ""Department of Acupuncture and Massage, Xi'an Traditional Chinese Medicine Hospital, Shaanxi University of Chinese Medicine, Xi'an, Shaanxi 710021, China. Electronic address: yuanyuan_ren@126.com.""}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710071, China.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'von Deneen', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710071, China. Electronic address: vondenk@ufl.edu.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710071, China.""}, {'ForeName': 'Guanya', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710071, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Acupuncture and Massage, Xi'an Traditional Chinese Medicine Hospital, Shaanxi University of Chinese Medicine, Xi'an, Shaanxi 710021, China.""}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Acupuncture and Massage, Xi'an Traditional Chinese Medicine Hospital, Shaanxi University of Chinese Medicine, Xi'an, Shaanxi 710021, China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Acupuncture and Massage, Xi'an Traditional Chinese Medicine Hospital, Shaanxi University of Chinese Medicine, Xi'an, Shaanxi 710021, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710038, China.""}, {'ForeName': 'Guangbin', 'Initials': 'G', 'LastName': 'Cui', 'Affiliation': ""Department of Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710038, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yongzhan', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, 710032, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, Shaanxi 710071, China. Electronic address: yizhang@xidian.edu.cn.""}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111047'] 907,31338769,High-intensity interval training combined with resistance training improved apnea-hypopnea index but did not modify oxygen desaturation index and oxygen saturation nadir in obese children with obstructive sleep apnea.,"PURPOSE To investigate the effect of high-intensity interval training (HIIT) combined with resistance training (RT) on sleep indices and vascular functions in obese children with obstructive sleep apnea (OSA). METHODS A quasi-experimental study. Forty-four obese children with OSA were allocated into either an exercise intervention (n = 22) or a usual care control group (n = 22). The exercise group received 24 min of HIIT (> 60% heart rate reserved) and 20 min of RT (50-80% one-repetition maximum), three times per week for 8 weeks. Primary outcomes included the apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and oxygen saturation (SaO 2 ) nadir. Secondary outcomes included the Sleep-Related Breathing Disorder-Pediatric Sleep Questionnaire (SRBD-PSQ) scores, vascular functions (flow-mediated dilation and mean blood flow velocity), and anthropometric variables. Outcomes were measured at baseline, at week 8, and at week 16. RESULTS No baseline differences were observed between groups. The compliance rate of exercise training was 99.47%. The AHI significantly decreased in the exercise group compared with the control group at week 16 (median AHI 1.30 to 0.60 and 1.00 to 1.60 episode/h, p = 0.01), but not at week 8. There were no differences between the groups in regard to the ODI and SaO 2 nadir and any secondary outcomes at weeks 8 and 16 (all p > 0.05). CONCLUSIONS The eight-week HIIT combined with RT decreased AHI in obese children with OSA at week 16 follow-up. No changes in the ODI, SaO 2 nadir, SRBD-PSQ, vascular function, and anthropometric outcomes were revealed at any time point. Further research is warranted.",2020,There were no differences between the groups in regard to the ODI and SaO 2 nadir and any secondary outcomes at weeks 8 and 16 (,"['obese children with obstructive sleep apnea (OSA', 'Forty-four obese children with OSA', 'obese children with obstructive sleep apnea']","['High-intensity interval training combined with resistance training', 'exercise intervention', 'exercise group received 24\xa0min of HIIT (>\u200960% heart rate reserved) and 20\xa0min of RT', 'high-intensity interval training (HIIT) combined with resistance training (RT', 'usual care control group']","['compliance rate of exercise training', 'apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and oxygen saturation (SaO 2 ) nadir', 'apnea-hypopnea index', 'ODI, SaO 2 nadir, SRBD-PSQ, vascular function, and anthropometric outcomes', 'Sleep-Related Breathing Disorder-Pediatric Sleep Questionnaire (SRBD-PSQ) scores, vascular functions (flow-mediated dilation and mean blood flow velocity), and anthropometric variables', 'sleep indices and vascular functions']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",44.0,0.0188402,There were no differences between the groups in regard to the ODI and SaO 2 nadir and any secondary outcomes at weeks 8 and 16 (,"[{'ForeName': 'Khomkrip', 'Initials': 'K', 'LastName': 'Longlalerng', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nuntigar', 'Initials': 'N', 'LastName': 'Sonsuwan', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sureeporn', 'Initials': 'S', 'LastName': 'Uthaikhup', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Suchart', 'Initials': 'S', 'LastName': 'Kietwatanachareon', 'Affiliation': 'Department of Radiologic Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Warunee', 'Initials': 'W', 'LastName': 'Kamsaiyai', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Duanpen', 'Initials': 'D', 'LastName': 'Panyasak', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sainatee', 'Initials': 'S', 'LastName': 'Pratanaphon', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand. sainatee.pra@cmu.ac.th.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01899-z'] 908,31320290,"Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis in sexually active women: a phase 1, single-blind, randomised, controlled trial.","BACKGROUND An intravaginal ring that releases the tenofovir prodrug, tenofovir disoproxil fumarate, provided 100% protection in macaques against simian HIV and was safe in a 14-day clinical trial in sexually abstinent women. We aimed to assess the safety and pharmacokinetics of this intravaginal ring over 90 days in sexually active women. METHODS We did a phase 1, single-blind, randomised, placebo-controlled trial to assess safety, pharmacokinetics, and acceptability of a tenofovir disoproxil fumarate intravaginal ring used continuously with monthly ring changes for 3 months. Sexually active women who were HIV negative were randomly assigned (3:1) to a tenofovir disoproxil fumarate ring or placebo ring. Primary safety endpoint was the proportion of women who had grade 2 or higher genitourinary adverse events judged related to study product and any grade 2 or higher adverse event as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. We quantified tenofovir disoproxil fumarate and tenofovir concentrations in cervicovaginal fluid, tenofovir in plasma, and tenofovir diphosphate, the active metabolite, in cervical tissue and dried blood spots 1 month after each ring insertion. We compared changes over time in cervicovaginal fluid cytokine and chemokine concentrations and vaginal microbiota. The study was electively stopped early and is registered with ClinicalTrials.gov, number NCT02762617. FINDINGS Between Feb 24 and July 20, 2017, 17 women were enrolled before study termination. 12 were assigned to receive the tenofovir disoproxil fumarate ring and five were assigned to receive the placebo ring. Two participants in the tenofovir disoproxil fumarate ring group completed 3 months of continuous ring use; eight were asked to discontinue ring use early because of ulcerations (grade 1) near the ring; in the remaining two women, rings were electively removed by study staff on day 20 and day 23. Ulcers were detected a mean of 32 days after ring use (range 23-56). Four of eight participants with ulcers were symptomatic with vaginal discharge; four had ulcers identified when examined; three had two ulcers; all ulcers resolved after ring removal. No participants in the placebo group developed ulcers. No grade 2 product-related adverse events were reported in either group and four non-product-related grade 2 adverse events were reported in the tenofovir disoproxil fumarate ring group. Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10 5 ng/mL [IQR 9·1 × 10 4 -1·1 × 10 5 ]) with the four who did not (6·0 × 10 4 ng/mL [5·6 × 10 4 -1·1 × 10 5 ]) develop ulcers. No significant changes in vaginal microbiota were detected in either group. Concentrations of multiple inflammatory cytokines and chemokines were significantly higher at days 14 and 28 compared with baseline in the tenofovir disoproxil fumarate ring group but not the placebo group. INTERPRETATION Future studies are needed to establish whether the unanticipated finding of ulcerations is specific to this tenofovir disoproxil fumarate ring or generalisable to other sustained topical release formulations of tenofovir or its prodrugs. FUNDING National Institutes of Health.",2019,Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10,"['10 5 ]) with the four who did not (6·0', 'sexually abstinent women', 'Sexually active women who were HIV negative', 'Between Feb 24 and July 20, 2017', '17 women were enrolled before study termination', 'sexually active women']","['tenofovir disoproxil fumarate', 'tenofovir', 'tenofovir disoproxil fumarate ring or placebo ring', 'placebo', 'Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis', 'tenofovir disoproxil fumarate and tenofovir', 'tenofovir prodrug, tenofovir disoproxil fumarate', 'placebo ring', 'tenofovir disoproxil fumarate intravaginal']","['grade 2 product-related adverse events', 'Cervicovaginal fluid tenofovir concentrations', 'ulcers', 'Concentrations of multiple inflammatory cytokines and chemokines', 'Ulcers', 'safety, pharmacokinetics, and acceptability', 'proportion of women who had grade 2 or higher genitourinary adverse events judged related to study product and any grade 2 or higher adverse event as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events', 'safety and pharmacokinetics', 'vaginal microbiota']","[{'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4520512', 'cui_str': 'Sexually abstinent (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1096319', 'cui_str': 'HIV pre-exposure prophylaxis'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",17.0,0.405657,Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0 × 10,"[{'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Keller', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Lianna', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Yerkes National Primate Research Center, Atlanta, GA, USA.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Ray', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Goymer', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Shada', 'Initials': 'S', 'LastName': 'Sinclair', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Aileen P', 'Initials': 'AP', 'LastName': 'McGinn', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Frank', 'Affiliation': 'Particle Sciences, Bethlehem, PA, USA.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Congzhou', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': ""Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, NY, USA.""}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Espinoza', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Hans M L', 'Initials': 'HML', 'LastName': 'Spiegel', 'Affiliation': 'Division of AIDS, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, MD, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Fredricks', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Marrazzo', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Yerkes National Primate Research Center, Atlanta, GA, USA.'}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Herold', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address: betsy.herold@einstein.yu.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30145-6'] 909,32491964,"Treatment of myofascial pain with a rapid laser therapy protocol compared to occlusal splint: A double-blind, randomized clinical trial.","OBJECTIVE To compare the effect of a rapid low-level laser therapy (LLLT) protocol to Michigan occlusal splint in the treatment of myofascial pain, as well as to evaluate their impact on Oral Health-Related Quality of Life (OHRQoL). METHODS Thirty participants were randomly allocated into three groups: G1: occlusal splint (n = 11), G2: LLLT (n = 10), and G3: LLLT placebo (n = 9). LLLT and placebo were applied in the points of pain upon palpation. RESULTS G1 presented improvement in pain ( p = 0.014) and in the diagnosis of myofascial pain ( p = 0.008), while G2 and G3 did not. Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not. CONCLUSION Michigan occlusal splint was effective in reducing pain and improving OHRQoL. Treatment with the rapid LLLT protocol only provided an improvement in OHRQoL.",2020,"Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not. ",['Thirty participants'],"['occlusal splint', 'rapid laser therapy protocol', 'G3: LLLT placebo', 'LLLT and placebo', 'G1: occlusal splint (n\xa0=\xa011), G2: LLLT', 'Michigan occlusal splint', 'rapid low-level laser therapy (LLLT) protocol to Michigan occlusal splint']","['Oral Health-Related Quality of Life (OHRQoL', 'pain and improving OHRQoL', 'diagnosis of myofascial pain', 'myofascial pain', 'OHRQoL', 'pain']","[{'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]",30.0,0.398388,"Regarding OHRQoL, G1 and G2 presented significant improvement ( p = 0.005, in both), whereas, G3 did not. ","[{'ForeName': 'Lucas Machado', 'Initials': 'LM', 'LastName': 'Maracci', 'Affiliation': ""Federal University of Santa Maria , Sant'Ana do Livramento, RS, Brazil.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Stasiak', 'Affiliation': ""Federal University of Santa Maria , Sant'Ana do Livramento, RS, Brazil.""}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Oliveira Chami', 'Affiliation': 'Dental Sciences, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Gisele Jung', 'Initials': 'GJ', 'LastName': 'Franciscatto', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Milanesi', 'Affiliation': 'Private Practice, Volunteer at Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'Figueiró', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Bernardon Silva', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Magáli Beck', 'Initials': 'MB', 'LastName': 'Guimarães', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Marquezan', 'Affiliation': 'Department of Stomatology, Federal University of Santa Maria , Santa Maria, RS, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1773661'] 910,32204895,MRI estimated changes in visceral adipose tissue and liver fat fraction in patients with obesity during a very low-calorie-ketogenic diet compared to a standard low-calorie diet.,"AIM To compare the changes in visceral adipose tissue (VAT), liver fat fraction, and liver stiffness using quantitative magnetic resonance imaging (MRI) during a very-low-calorie ketogenic (VLCK) diet and a standard low-calorie diet (LC). MATERIALS AND METHODS The study involved secondary analysis of prospective collected clinical data. Patients undergoing weight loss interventions were randomised to either a LC or a VLCK diet. VAT, liver fat fraction, and stiffness were measured at baseline and after 2 months. RESULTS Forty-six patients were included; 39 patients were evaluated at baseline and at 2 months follow-up. Mean weight loss was -9.7±3.8 kg (interquartile range [IQR]: -12.3; -7 kg) in the VLCK group and -1.67±2.2 kg (IQR: -3.3, -0.1 kg) in the LC group (p<0.0001). Mean VAT reductions were -39.3±40 cm 2 (IQR: -52, -10 cm 2 ) and -12.5±38.3 cm 2 (IQR: -29, 5 cm 2 ; p=0.0398), and mean liver proton density fat fraction (PDFF) reductions were -4.77±4.2% (IQR: -7.3, -1.7%) and -0.79±1.7%, (IQR: -1.8, -0.4%; p<0.005) in the VLCK group and in the LC group, respectively. No significant changes in liver stiffness occurred from baseline to follow-up. CONCLUSION A VLCK diet resulted in greater weight loss than a standard low-calorie diet and in significantly greater reduction in liver PDFF. As anthropometric measurements may not correlate with liver fat changes, it may be advantageous to include quantitative MRI to the monitoring strategies of patients undergoing weight-loss programmes.",2020,"Mean VAT reductions were -39.3±40 cm 2 (IQR: -52, -10 cm 2 ) and -12.5±38.3 cm 2 (IQR: -29, 5 cm 2 ; p=0.0398), and mean liver proton density fat fraction (PDFF) reductions were -4.77±4.2% (IQR: -7.3, -1.7%) and -0.79±1.7%, (IQR: -1.8, -0.4%; p<0.005) in the VLCK group and in the LC group, respectively.","['patients with obesity', 'Forty-six patients were included; 39 patients', 'Patients undergoing weight loss interventions', 'patients undergoing weight-loss programmes']","['VLCK', 'quantitative magnetic resonance imaging (MRI) during a very-low-calorie ketogenic (VLCK) diet and a standard low-calorie diet (LC', 'LC or a VLCK diet']","['VAT, liver fat fraction, and stiffness', 'visceral adipose tissue (VAT), liver fat fraction, and liver stiffness', 'weight loss', 'Mean VAT reductions', 'liver stiffness', 'mean liver proton density fat fraction (PDFF) reductions', 'liver PDFF', 'visceral adipose tissue and liver fat fraction', 'Mean weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",46.0,0.0401929,"Mean VAT reductions were -39.3±40 cm 2 (IQR: -52, -10 cm 2 ) and -12.5±38.3 cm 2 (IQR: -29, 5 cm 2 ; p=0.0398), and mean liver proton density fat fraction (PDFF) reductions were -4.77±4.2% (IQR: -7.3, -1.7%) and -0.79±1.7%, (IQR: -1.8, -0.4%; p<0.005) in the VLCK group and in the LC group, respectively.","[{'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Cunha', 'Affiliation': 'Liver Imaging Group, Radiology, University of California San Diego, California, USA; MRI Department, Clínica de Diagnóstico por Imagem - CDPI/DASA, Rio de Janeiro, Brazil. Electronic address: gcunha@health.ucsd.edu.'}, {'ForeName': 'L Lugarino', 'Initials': 'LL', 'LastName': 'Correa de Mello', 'Affiliation': 'Serviço de Obesidade, Transtornos Alimentares e Metabologia (SOTAM), Instituto Estadual de Endocrinologia (IEDE), Rio de Janeiro, Brazil.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Hasenstab', 'Affiliation': 'Liver Imaging Group, Radiology, University of California San Diego, California, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spina', 'Affiliation': 'CliniCoop, Rio de Janeiro, Brazil.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bussade', 'Affiliation': 'Departamento de Pós-Graduação Em Clínica Médica, Pontifícia Universidade Católica (PUC), Rio de Janeiro, Brazil.'}, {'ForeName': 'J Marques', 'Initials': 'JM', 'LastName': 'Prata Mesiano', 'Affiliation': 'MRI Department, Clínica de Diagnóstico por Imagem - CDPI/DASA, Rio de Janeiro, Brazil.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Coutinho', 'Affiliation': 'Serviço de Obesidade, Transtornos Alimentares e Metabologia (SOTAM), Instituto Estadual de Endocrinologia (IEDE), Rio de Janeiro, Brazil.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Guzman', 'Affiliation': 'Medical Department Pronokal, Barcelona, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sajoux', 'Affiliation': 'Medical Department Pronokal, Barcelona, Spain.'}]",Clinical radiology,['10.1016/j.crad.2020.02.014'] 911,28845751,Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease.,"BACKGROUND Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. METHODS We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P=0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P=0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P=0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P=0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P=0.31). CONCLUSIONS Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846 .).",2017,"There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P=0.31). ","['10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter']","['canakinumab', 'Antiinflammatory Therapy with Canakinumab', 'placebo']","['fatal infection', 'hospitalization for unstable angina that led to urgent revascularization', 'incidence rate', 'cause mortality', 'nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death', 'hazard ratios', 'lipid levels', 'high-sensitivity C-reactive protein level', 'rate of recurrent cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0475211', 'cui_str': 'L'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C1096024', 'cui_str': 'Antiinflammatory therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",10061.0,0.452367,"There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P=0.31). ","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Ballantyne', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fonseca', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Nicolau', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pella', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Cifkova', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Lorenzatti', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Kobalava', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Vida-Simiti', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Dellborg', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Paulo R F', 'Initials': 'PRF', 'LastName': 'Rossi', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Roland P T', 'Initials': 'RPT', 'LastName': 'Troquay', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention (P.M.R., B.M.E., J.G.M., R.J.G.) and the Cardiovascular Division (P.M.R., B.M.E., P.L.), Brigham and Women's Hospital, Harvard Medical School, Boston; Novartis, East Hanover, NJ, and Basel, Switzerland (T.T., W.H.C.); Baylor College of Medicine, Houston (C.B.); Federal University of São Paulo (F.F.) and the Heart Institute (InCor), University of São Paulo Medical School (J.N.), São Paulo, and Faculdade Evangelica de Medicina do Parana, Curitiba (P.R.F.R.) - all in Brazil; Deutsches Herzzentrum München, Technische Universität München, German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), and the Department of Cardiology and Berlin-Brandenburg Center for Regenerative Therapies, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin (S.D.A.) - both in Germany; Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), Alkmaar Medical Center, Alkmaar (J.H.C.), and VieCuri Medical Center for Northern Limburg, Venlo (R.P.T.T.) - all in the Netherlands; Manipal Hospital, St. John's Research Institute, Bangalore, India (P.P.); Pavol Jozef Safarik University, Kosice, Slovakia (D.P.); McGill University, Montreal (J.G.); First Faculty of Medicine and Thomayer Hospital, Prague, Czech Republic (R.C.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of Szeged, Szeged, Hungary (T.F.); City Hospital No. 64, Medical Institute RUDN University, Moscow (Z.K.); Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (L.V.-S.); University of East Anglia, Norwich Medical School, Norwich, United Kingdom (M.F.); Tohoku University Hospital, Sendai (H.S.), and National Cerebral and Cardiovascular Center, Osaka (H.O.) - both in Japan; and Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden (M.D.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1707914'] 912,31142441,Analysis from the EMPA-REG OUTCOME ® trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics.,"In patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease, empagliflozin (EMPA) decreased progression of chronic kidney disease (CKD), likely via a reduction in intraglomerular pressure. Due to prevalent comorbidities, such as hypertension and albuminuria, patients often receive other agents that alter intrarenal hemodynamics, including angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs), calcium channel blockers (CCBs) and diuretics. Nonsteroidal anti-inflammatory drugs (NSAIDs) may also be used by some individuals. In this exploratory, non-prespecified analysis, we investigated whether the kidney benefits of EMPA are altered in individuals already using the medications in these categories. In the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME ® ) trial, 7020 patients were essentially equally randomized to EMPA 10 mg, 25 mg or placebo added to their standard care. Differences in risk of incident or worsening nephropathy for pooled EMPA vs placebo across subgroups by baseline background medications (to which patients were not randomized) were assessed using a Cox proportional hazards model. Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect. As a representative example, the risk for acute renal failure was overall slightly increased in patients using ACEi/ARBs in all groups (placebo, EMPA 10 mg or EMPA 25 mg) but incidence rates were numerically lower in those assigned to EMPA. Similar patterns were observed for other medications included in this analysis. Thus, EMPA may assist to prevent CKD progression in patients with T2DM with CV disease, irrespective of common background medications that alter intrarenal hemodynamics, and without increasing acute renal adverse events.",2019,"Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect.","['Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME ® ) trial', '7020 patients', 'patients with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM) and cardiovascular (CV) disease', 'patients with T2DM with CV disease']","['empagliflozin', 'placebo', 'empagliflozin (EMPA', 'BI 10773 (Empagliflozin', 'EMPA', 'EMPA 10 mg, 25 mg or placebo', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['chronic kidney disease', 'risk of incident or worsening nephropathy', 'incidence rates', 'acute renal failure']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490349', 'cui_str': 'BI10773'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}]",7020.0,0.0746079,"Risk reductions in incident or worsening nephropathy with EMPA were consistent across medication subgroups, with no heterogeneity of treatment effect.","[{'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine IV (Nephrology and Hypertension), Medical University, Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Weir', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany; Boehringer Ingelheim International GmbH, Ingelheim, Germany; Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Department of Medicine and Department of Physiology, Division of Nephrology, University Health Network, University of Toronto, Canada. Electronic address: david.cherney@uhn.ca.'}]",Kidney international,['10.1016/j.kint.2019.02.033'] 913,31327306,Heavy Drinking among Women Receiving Intensive Motivational Interviewing: 6-Month Outcomes.,"Compared to men, women with alcohol use disorders experience more severe consequences related to drinking. Intensive Motivational Interviewing (IMI) is a new 9-session version of Motivational Interviewing (MI) designed for women with alcohol use disorders. The current study reports outcomes from a randomized clinical trial of IMI compared to a single session of MI. Data were collected at baseline, 2-month, and 6-month follow-up. In addition to a standard ""intent-to-treat"" (ITT) analysis, we conducted disaggregated subgroup analyses of women who were heavy drinkers and a ""per protocol"" (PP) analysis of women in the IMI condition who attended 7-9 sessions (80% of the IMI sample). Women in both study conditions made large reductions in drinking between baseline and 2 months that were maintained at 6 months. Generalized estimating equation (GEE) models using the full sample (N = 215) did not show time by condition differences, but heavy drinkers(n = 153) receiving IMI showed significantly larger reductions in drinking at 2- and 6-month follow-up than the comparison condition. Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points. Results support the efficacy of IMI in terms of reducing drinking, particularly among women who are heavy drinkers.",2019,Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points.,"['women who are heavy drinkers', 'women with alcohol use disorders', 'heavy drinkers', 'Women Receiving Intensive Motivational Interviewing', 'women who were heavy drinkers and a ""per protocol"" (PP) analysis of women in the IMI condition who attended 7-9 sessions (80% of the IMI sample']","['Intensive Motivational Interviewing (IMI', 'Motivational Interviewing (MI', 'IMI', 'standard ""intent-to-treat"" (ITT']",['Heavy Drinking'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",,0.0245226,Assessment of heavy drinkers using the PP sample showed larger between condition differences favoring IMI at both follow-up time points.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Polcin', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Madhabika B', 'Initials': 'MB', 'LastName': 'Nayak', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Korcha', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Witbrodt', 'Affiliation': 'Alcohol Research Group, Public Health Institute, Emeryville, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Salinardi', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}, {'ForeName': 'Gantt', 'Initials': 'G', 'LastName': 'Galloway', 'Affiliation': 'Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Behavioral Health and Recovery Studies, Public Health Institute, Lafayette, CA, USA.'}]",Journal of psychoactive drugs,['10.1080/02791072.2019.1634302'] 914,31339055,A Multidisciplinary Intervention to Improve Care for High-Risk COPD Patients.,"Chronic obstructive pulmonary disease (COPD) exacerbations contribute to both costs and patient morbidity. The authors designed a quality project to improve care for high-risk COPD patients admitted with an exacerbation. An electronic medical record report was used to target admitted high-risk COPD patients for an intervention that included pulmonary and respiratory therapy consults, post-discharge phone calls from a patient navigator, referrals to palliative services when appropriate, and bedside delivery of medications. The control population was a similar group of patients at a community partner hospital who received usual care. In all, 157 unique patients were enrolled over 16 months; referrals to palliative care services increased and rates of outpatient follow-up improved. There was no difference in readmissions or emergency department visits between the 2 groups. Better coordination of outpatient care and attention to psychosocial burdens were identified as possible targets for future interventions.",2020,There was no difference in readmissions or emergency department visits between the 2 groups.,"['high-risk COPD patients admitted with an exacerbation', 'admitted high-risk COPD patients', 'Chronic obstructive pulmonary disease (COPD) exacerbations', '157 unique patients were enrolled over 16 months; referrals to palliative care services increased and rates of outpatient follow-up improved', 'High-Risk COPD Patients', 'patients at a community partner hospital who received usual care']",['Multidisciplinary Intervention'],['readmissions or emergency department visits'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0584096', 'cui_str': 'Referral to palliative care service (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",,0.0223049,There was no difference in readmissions or emergency department visits between the 2 groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gay', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'McNeil', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}]",American journal of medical quality : the official journal of the American College of Medical Quality,['10.1177/1062860619865329'] 915,32208006,Use of an Online Crowdsourcing Platform to Assess Patient Comprehension of Radiology Reports and Colloquialisms.,"OBJECTIVE. The purpose of this study was to use an online crowdsourcing platform to assess patient comprehension of five radiology reporting templates and radiology colloquialisms. MATERIALS AND METHODS. In this cross-sectional study, participants were surveyed as patient surrogates using a crowdsourcing platform. Two tasks were completed within two 48-hour time periods. For the first crowdsourcing task, each participant was randomly assigned a set of radiology reports in a constructed reporting template and subsequently tested for comprehension. For the second crowdsourcing task, each participant was randomly assigned a radiology colloquialism and asked to indicate whether the phrase indicated a normal, abnormal, or ambivalent finding. RESULTS. A total of 203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication. The payment totaled $31.96. Of 812 radiology reports read, 384 (47%) were correctly interpreted by the patient surrogates. Patient surrogates had higher rates of comprehension of reports written in the patient summary (57%, p < 0.001) and traditional unstructured in combination with patient summary (51%, p = 0.004) formats than in the traditional unstructured format (40%). Most of the patient surrogates (114/203 [56%]) expressed a preference for receiving a full radiology report via an electronic patient portal. Several radiology colloquialisms with modifiers such as ""low,"" ""underdistended,"" and ""decompressed"" had low rates of comprehension. CONCLUSION. Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research. Patient summaries can help increase patient comprehension of radiology reports. Radiology colloquialisms are likely to be misunderstood by patients.",2020,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","['participants were surveyed as patient surrogates using a crowdsourcing platform', '203 participants enrolled for the first task and 1166 for the second within 48 hours of task publication']",[],['rates of comprehension of reports written'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3494387', 'cui_str': 'Crowdsource'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0034036', 'cui_str': 'Publications'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",203.0,0.0752139,"Use of the crowdsourcing platform is an expeditious, cost-effective, and customizable tool for surveying laypeople in sentiment- or task-based research.","[{'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Zafar', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}, {'ForeName': 'Tessa S', 'Initials': 'TS', 'LastName': 'Cook', 'Affiliation': 'Department of Radiology, Hospital of the University of Pennsylvania, 3400 Spruce St, 1 Silverstein, Philadelphia, PA 19104.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22202'] 916,31301748,"Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis.","BACKGROUND People severely impaired with progressive multiple sclerosis spend much of their day sitting, with very few options to improve motor function. As a result, secondary physical and psychosocial complications can occur. Effective and feasible self-management strategies are needed to reduce sedentary behaviour and enhance motor function. In this study, we aimed to assess the clinical and cost effectiveness of a home-based, self-managed, standing frame programme. METHODS SUMS was a pragmatic, multicentre, randomised controlled superiority trial of people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK. The study had assessor-blinded outcome assessments with use of clinician-rated and patient-rated measures at baseline, 20 weeks, and 36 weeks. After baseline assessment, participants were randomised (1:1) by computer-generated assignment to either a standing frame programme plus usual care or usual care alone. The intervention consisted of two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls (15 min per call). Participants were asked to stand for 30 min, three times per week over 20 weeks, and encouraged to continue in the longer term, although no further physiotherapy support was provided. The primary clinical outcome was motor function measured by the Amended Motor Club Assessment (AMCA) score at week 36, analysed in the modified intention-to-treat population (excluding only patients who were deemed ineligible after randomisation, those who withdrew from the trial and were unwilling for their previously collected data to be used, or those who did not provide baseline and week 36 measurements). A 9-point AMCA score change was considered clinically meaningful a priori. Adverse events were collected through a daily preformatted patient diary throughout the 36 weeks and analysed in the modified intention-to-treat population. An economic assessment established the resources required to provide the standing frame programme, estimated intervention costs, and estimate cost effectiveness. This trial is registered with the International Standard Randomised Controlled Trials, number ISRCTN69614598. FINDINGS Between Sept 16, 2015, and April 28, 2017, 285 people with progressive multiple sclerosis were screened for eligibility, and 140 were randomly assigned to either the standing frame group (n=71) or the usual care group (n=69). Of these, 122 completed the primary outcome assessment (61 participants in both groups) for the modified intention-to-treat analysis. The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014). For adverse events collected through patient diaries, we observed a disparity between the two groups in the frequency of short-term musculoskeletal pain (486 [41%] of 1188 adverse events in the standing frame group vs 160 [22%] of 736 adverse events in the usual care group), which was potentially related to the intervention. The musculoskeletal pain lasted longer than 7 days in five participants (two in the standing frame group and three in the usual care group). No serious adverse events related to the study occurred. The standing frame group had a mean 0·018 (95% CI -0·014 to 0·051) additional quality-adjusted life-years (QALYs) compared with those of the usual care group, and the estimated incremental cost-per-QALY was approximately £14 700. INTERPRETATION The standing frame programme significantly increased motor function in people with severe progressive multiple sclerosis, although not to the degree that was considered a priori as clinically meaningful. The standing frame is one of the first physiotherapy interventions to be effective in this population. We suggest that the programme is feasible as a home-based, self-managed intervention that could be routinely implemented in clinical practice in the UK. FUNDING UK National Institute of Health Research.",2019,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","['285 people with progressive multiple sclerosis', 'Between Sept 16, 2015, and April 28, 2017', 'people with severe progressive multiple sclerosis', 'people with progressive multiple sclerosis (SUMS', 'people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK']","['computer-generated assignment to either a standing frame programme plus usual care or usual care alone', 'home-based standing frame programme', 'usual care group', 'two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls']","['sedentary behaviour and enhance motor function', 'frequency of short-term musculoskeletal pain', 'musculoskeletal pain', 'AMCA score', 'Adverse events', 'motor function', 'motor function measured by the Amended Motor Club Assessment (AMCA) score']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",61.0,0.129963,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK. Electronic address: jenny.freeman@plymouth.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Norwich MS Centre, Norwich, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jarrett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Mardon Neurorehabilitation Centre, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': 'University of Exeter Medical School, Health Economics Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'NIHR Research Design Service, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajicek', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK; Peninsula Clinical Trials Unit, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30190-5'] 917,31307948,"Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies.","BACKGROUND Primary analyses of the SWORD-1 and SWORD-2 trials at 48 weeks showed that switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to continuing a standard three-drug or four-drug antiretroviral regimen for maintenance of virological suppression in people with HIV-1. Here, we present efficacy and safety data from the 100-week analysis of the trials. METHODS SWORD-1 and SWORD-2 are identically designed, randomised, open-label phase 3 studies at 65 centres in 13 countries and 60 centres in 11 countries, respectively. Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1 RNA copies per mL of plasma for at least 6 months were randomly assigned (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine orally once daily (early-switch group) or to continue their standard regimen for 52 weeks before switching to the dolutegravir plus rilpivirine combination (ie, the late-switch group). In this analysis of week 100 data, the efficacy endpoint of interest was the proportion of participants with fewer than 50 copies of HIV-1 RNA per mL of plasma (per the US Food and Drug Administration snapshot algorithm). This outcome was assessed in all randomly assigned participants who received at least one dose of the study drug. Data were analysed after the last participant completed week 100 (Sept 15, 2017) and verified through the data cutoff (Nov 21, 2017). SWORD-1 and SWORD-2 are registered with ClinicalTrials.gov, numbers NCT02429791 and NCT02422797, respectively. FINDINGS 513 participants were randomly assigned to dolutegravir plus rilpivirine (ie, the early-switch group) and 511 to continue their standard ART regimen, 477 of whom then switched to dolutegravir plus rilpivirine at week 52 (ie, the late-switch group). At week 100, 456 (89% [95% CI 86-92]) of 513 participants in the early-switch group and 444 (93% [91-95]) of 477 in the late-switch group had fewer than 50 HIV-1 RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group. The most common drug-related adverse events were headache (11 participants in the early-switch group [2%] vs eight [2%] in the late-switch group) and nausea (eight [2%] vs five [1%]). INTERPRETATION The combination of dolutegravir plus rilpivirine sustained virological suppression of HIV-1, was associated with a low frequency of virological failure, and had a favourable safety profile, which support its use as a nucleoside reverse transcriptase inhibitor-sparing and protease inhibitor-sparing alternative to three-drug regimens that reduces overall exposure to ART. FUNDING ViiV Healthcare and Janssen Pharmaceutica.",2019,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"['65 centres in 13 countries and 60 centres in 11 countries, respectively', '513 participants', 'people with HIV-1', 'adults with HIV-1', 'Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1']","['dolutegravir-rilpivirine', 'rilpivirine combination', 'dolutegravir plus 25 mg rilpivirine', 'dolutegravir plus rilpivirine']","['headache', 'nausea', 'RNA copies per mL. Drug-related adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",513.0,0.24491,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': ""IDIBELL-Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Bogner', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, NSW, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CHG-Hôpital Delafontaine, Saint Denis, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'ViiV Healthcare, Brentford, UK. Electronic address: lesley.p.kahl@viivhealthcare.com.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Blair', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Adkison', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Matthews', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Janssen Pharmaceutica, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30149-3'] 918,31315799,Superficial Surgical Site Infection Following the Use of Intracutaneous Sutures Versus Staples.,"BACKGROUND Superficial wound infections after gastrointestinal surgery markedly impair the affected patients' quality of life. As it is still unknown which method of skin closure is best for the reduction of wound infections in elective gastrointestinal sur- gery, we compared the frequency of wound infections after intracutaneous suturing versus skin stapling. METHODS In a prospective, randomized, single-center study, patients undergoing elective gastrointestinal surgery were intraoperatively randomized to skin closure either with an intracutaneous suture or with staples. The primary endpoint-the occurrence of a grade A1 wound infection within 30 days of surgery-was evaluated according to the intention-to-treat principle. RESULTS Out of a total of 280 patients, 141 were randomized to intracutaneous suturing and 139 to stapling. The groups did not differ significantly with respect to age, sex, or ASA classification. 19 of the 141 patients in the intracutaneous suturing group (13.5%) had a grade A1 wound infection, compared with 23 of 139 in the stapling group (16.6%) (odds ratio [OR]: 0.79; 95% confidence interval: [0.41; 1.52]; p = 0.47). A multiple regression analysis revealed that the type of surgery (colorectal vs. other), the approach, and the incision length were independent risk factors for a grade A1 wound infection. When wound dehiscences were additionally considered, wound complications were found to have arisen significantly more often in the stapling group than in the intracutaneous suturing group (16.3% [23/141] versus 30.2% [42/139], OR: 0.45 [0.25; 0.80]; p = 0.006). CONCLUSION In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.",2019,"In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.","['patients undergoing elective gastrointestinal surgery', '280 patients, 141 were randomized to']","['Intracutaneous Sutures Versus Staples', 'intracutaneous suturing and 139 to stapling', 'intracutaneous suturing', 'intracutaneous suturing versus skin stapling', 'skin closure either with an intracutaneous suture or with staples']","['wound complications', 'wound dehiscences', 'Superficial Surgical Site Infection', 'occurrence of a grade A1 wound infection', 'grade A1 wound infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C1096106'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",280.0,0.0479287,"In elective gastrointestinal surgery, intracutaneous suturing was not found to be associated with a lower rate of superficial wound infections than skin stapling, but fewer wound dehiscences occurred in the intracutaneous suturing group.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Maurer', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery Universität Gießen und Marburg GmbH, Marburg; Clinica Trials Coordination Center (KKS), Philipps-Universität Marburg, Marburg.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Maschuw', 'Affiliation': ''}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Aminossadati', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neubert', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': ''}, {'ForeName': 'Detlef K', 'Initials': 'DK', 'LastName': 'Bartsch', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0365'] 919,31299857,PACAP27 induces migraine-like attacks in migraine patients.,"INTRODUCTION Pituitary adenylate cyclase-activating polypeptide (PACAP) is found in two functional isoforms, namely PACAP38 and PACAP27. The migraine-inducing properties of PACAP38 are well studied. However, it is not known whether the lesser-known and under-studied protein isoform, PACAP27, can also induce migraine attacks. Here, we studied the effect of human PACAP27 infusion on induction of migraine in a provocation model. METHODS In a crossover study, 20 migraine without aura patients were randomly assigned to receive human PACAP27 (10 picomol/kg/min) or saline (placebo) infusion over 20 min. We recorded the migraine and associated symptoms. RESULTS All patients completed the study. PACAP27 provoked migraine-like attacks in 11 patients (55%) and two developed attacks after placebo (10%) ( p  = 0.022). The headache intensity and duration after PACAP27 was significantly greater compared to placebo ( p  = 0.003). CONCLUSION PACAP27 triggers migraine attacks without aura. These novel data strengthen the role of PACAP and its receptors in migraine pathogenesis.",2020,"The headache intensity and duration after PACAP27 was significantly greater compared to placebo ( p  = 0.003). ","['migraine patients', '20 migraine without aura patients']","['Pituitary adenylate cyclase-activating polypeptide (PACAP', 'human PACAP27 infusion', 'PACAP27', 'placebo', 'saline (placebo', 'human PACAP27']","['PACAP27 provoked migraine-like attacks', 'headache intensity and duration after PACAP27', 'migraine-like attacks']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}]","[{'cui': 'C0001492', 'cui_str': 'Adenylate Cyclase'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0071163', 'cui_str': 'PACAP'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0084057', 'cui_str': 'PACAP27'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0084057', 'cui_str': 'PACAP27'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",20.0,0.0612992,"The headache intensity and duration after PACAP27 was significantly greater compared to placebo ( p  = 0.003). ","[{'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Arngrim', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419864507'] 920,31305281,"Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis.","BACKGROUND Left ventricular diastolic dysfunction (LVDD) refers to impaired cardiac diastolic relaxation and may be improved by targeted heart rate reduction (THR). The authors evaluated whether a combination of carvedilol and ivabradine, an If channel blocker that reduces heart rate without affecting blood pressure, could improve LVDD and outcomes in cirrhosis. PATIENTS AND METHODS THR was defined as heart rate reduction to 55 to 65 beats per minute. Of 260 patients with cirrhosis, 189 (72%) with LVDD were randomized to THR [group (Gr.)A; n=94; carvedilol±ivabradine)] or standard care (Gr.B; n=95; no β-blockers) and followed for 12 months. RESULTS In Gr.A, THR was achieved at 4 weeks in 88 (93%) patients (responders, R): 48 (61.5%) with carvedilol alone and 40 (86.9%) of 46 patients with additional ivabradine. In Gr.A, LVDD reversed in 16 (20.5%) and improved from grade 2 to 1 in 34 (35.4%)], whereas in Gr.B, it progressed from grade 1 to 2 in 10 (10.5%) patients. At 12 months, 21 (11.1%) patients died, 6 (14%) in Gr.A and 15 (18%) in Gr.B (P=0.240), but no mortality was seen in those who had persistent THR at 1 year (n=78; P=0.000). In multivariate analysis, model for end-stage liver disease [hazard ratio (HR), 1.52; 95% confidence interval (CI), 1.22-2.75; P=0.034] and E-wave transmitral/early diastolic mitral annular velocity (HR, 1.28; 95% CI, 1.23-2.42; P=0.048) predicted 1-year mortality. Nonresponders had an increased mortality risk (HR, 1.3; 95% CI, 1.2-1.8; P=0.046) independent of age, gender, and baseline model for end-stage liver disease. Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders. More patients in Gr.B developed acute kidney injury (odds ratio, 4.2; 95% CI, 2.8-10.5; P=0.027) and encephalopathy (odds ratio, 6.6; 95% CI, 1.9-9.7; P=0.040). CONCLUSIONS Ivabradine combined with carvedilol improves LVDD, achieves THR more often and reduces risk of encephalopathy, acute kidney injury with improved survival in patients with cirrhosis.",2020,"Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders.","['260 patients with cirrhosis, 189 (72%) with LVDD', 'patients with cirrhosis', '46 patients with additional ivabradine']","['Carvedilol Combined With Ivabradine', 'Ivabradine combined with carvedilol', 'THR', 'carvedilol±ivabradine)] or standard care (Gr.B; n=95; no β-blockers', 'carvedilol', 'carvedilol and ivabradine', 'channel blocker']","['LVDD', 'no mortality', 'E-wave transmitral/early diastolic mitral annular velocity', 'heart rate without affecting blood pressure', 'heart rate reduction', '1-year mortality', 'Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone', 'THR', 'acute kidney injury', 'mortality risk', 'Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis', 'encephalopathy']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4301608', 'cui_str': 'carvedilol and ivabradine'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1273070', 'cui_str': 'Left ventricular diastolic dysfunction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}]",260.0,0.28365,"Levels of norepinephrine, N terminal brain natriuretic peptide, plasma renin activity, and aldosterone were reduced (P<0.01) in responders.","[{'ForeName': 'Madhumita', 'Initials': 'M', 'LastName': 'Premkumar', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Devaraja', 'Initials': 'D', 'LastName': 'Rangegowda', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Tanmay', 'Initials': 'T', 'LastName': 'Vyas', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Jelen S', 'Initials': 'JS', 'LastName': 'Khumuckham', 'Affiliation': 'Cardiology.'}, {'ForeName': 'Saggere M', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Departments of Hepatology.'}, {'ForeName': 'Sherin S', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Biochemistry.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Goyal', 'Affiliation': 'Biochemistry.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Epidemiology, Institute of Liver and Biliary Sciences, New Delhi.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Departments of Hepatology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001219'] 921,31302695,Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.,"OBJECTIVE This extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with SLE to continue belimumab treatment, in order to evaluate its long-term safety and tolerability including organ damage accrual. METHODS In this multicentre, long-term extension study (GlaxoSmithKline Study BEL112234) patients received i.v. belimumab every 4 weeks plus standard therapy. Adverse events (AEs) were assessed monthly and safety-associated laboratory parameters were assessed at regular intervals. Organ damage (SLICC/ACR Damage Index) was assessed every 48 weeks. The study continued until belimumab was commercially available, with a subsequent 8-week follow-up period. RESULTS A total of 738 patients entered the extension study and 735/738 (99.6%) received one or more doses of belimumab. Annual incidence of AEs, including serious and severe AEs, remained stable or declined over time. Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study. Eleven deaths occurred (and two during post-treatment follow-up), including one (cardiogenic shock) considered possibly related to belimumab. Laboratory parameters generally remained stable. The mean (s.d.) SLICC/ACR Damage Index score was 0.6 (1.02) at baseline (prior to the first dose of belimumab) and remained stable. At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. CONCLUSION Belimumab displayed a stable safety profile with no new safety signals. There was minimal organ damage progression over 8 years. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov, NCT00424476 (BLISS-52), NCT00410384 (BLISS-76), NCT00732940 (BEL112232), NCT00712933 (BEL112234).",2020,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. ","['patients with systemic lupus erythematosus treated with', '738 patients entered the extension study and 735/738 (99.6%) received one or more doses of', 'Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study']","['placebo', 'belimumab']","['Eleven deaths', 'Annual incidence of AEs, including serious and severe AEs', 'SLICC/ACR Damage Index score', 'minimal organ damage progression', 'Organ damage (SLICC/ACR Damage Index', 'Adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",738.0,0.202432,"At study year 8, 57/65 (87.7%) patients had no change in SLICC/ACR Damage Index score from baseline, indicating low organ damage accrual. ","[{'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra V', 'Initials': 'SV', 'LastName': 'Navarra', 'Affiliation': 'University of Santo Tomas Hospital, Manila, Philippines.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Levy', 'Affiliation': 'Rio de Janeiro State University, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Kerala Institute of Medical Sciences (KIMS), Kerala, India.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lustine', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Adamkovic', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fettiplace', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Mei-Lun', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez279'] 922,9788075,Event-related fMRI and the hemodynamic response.,"Event-related functional magnetic resonance imaging (ER-fMRI) methods are allowing a new spectrum of task designs to be explored with brain imaging techniques. Individual trial events can be presented rapidly, in randomly intermixed order, and the hemodynamic responses associated with individual trial events appreciated. The basis of ER-fMRI is that the hemodynamic response tracks neuronal activity on the order of seconds and, in many situations, summates over trials in a manner well predicted by a linear model--even for trials spaced as briefly as 2 sec apart. These properties are discussed, as well as certain basic characteristics of the hemodynamic response in the context of ER-fMRI.",1998,"Individual trial events can be presented rapidly, in randomly intermixed order, and the hemodynamic responses associated with individual trial events appreciated.",[],['functional magnetic resonance imaging (ER-fMRI'],[],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}]",[],,0.0333738,"Individual trial events can be presented rapidly, in randomly intermixed order, and the hemodynamic responses associated with individual trial events appreciated.","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Buckner', 'Affiliation': 'Department of Psychology, Washington University, St. Louis, Missouri 63130, USA.'}]",Human brain mapping,[] 923,31145031,Prevention of Metabolic Syndrome by Telephone-Delivered Lifestyle Intervention in a Real-World Setting: Sub-Analysis of a Cluster-Randomized Trial.,"Background: Evidence of the long-term benefits of telephone-delivered lifestyle interventions is limited. This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. Methods: Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a prospective, cluster-randomized controlled trial designed to investigate whether goal-focused lifestyle coaching over the telephone can effectively reduce the incidence of type 2 diabetes development in high-risk individuals in a primary health care setting. We extracted 753 and 844 J-DOIT1 participants from the intervention and controls arms, respectively, who had IFG but did not meet the MetS criteria at baseline. The intervention arm received goal-focused lifestyle support delivered by health care providers via telephone over a 1-year period. The endpoint was the development of incident MetS, defined based on the Adult Treatment Panel III criteria modified for Japan. Results: During the median follow-up period of 4.9 years, 8.0% of the intervention arm and 12.0% of the control arm developed MetS. Overall, the hazard ratio (HR) for the development of MetS was 0.75 [95% confidence interval (CI), 0.52-1.09; P  = 0.14] in the intervention arm. However, the HR in overweight or obese [body mass index (BMI) ≥23 kg/m 2 ] individuals was significantly reduced to 0.63 (95% CI, 0.41-0.95; P  = 0.029), but not in lean (BMI <23 kg/m 2 ) individuals. Conclusion: Telephone-delivered lifestyle intervention effectively reduced the incidence of MetS in overweight and obese subjects in a real-world setting. Clinical trial registration number: UMIN000000662 (registered March 30, 2007; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000798).",2019,This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. ,"['high-risk individuals in a primary health care setting', 'Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1', 'overweight and obese subjects in a real-world setting', 'subjects diagnosed with impaired fasting glucose (IFG) during health checkups']","['telephone-delivered lifestyle interventions', 'goal-focused lifestyle support delivered by health care providers via telephone', 'lifestyle coaching over the telephone', 'Telephone-Delivered Lifestyle Intervention', 'Telephone-delivered lifestyle intervention', 'telephone-delivered lifestyle intervention']","['MetS', 'hazard ratio (HR', 'HR in overweight or obese [body mass index', 'metabolic syndrome (MetS', 'incidence of MetS']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.196483,This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. ,"[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sakane', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kotani', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Suganuma', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Juichi', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of General Medicine/Family & Community Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Health Management Center and Diagnostic Imaging Center, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nirengi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Kuzuya', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}]",Metabolic syndrome and related disorders,['10.1089/met.2018.0130'] 924,31122876,Consistent use of bedtime parenting strategies mediates the effects of sleep education on child sleep: secondary findings from an early-life randomized controlled trial.,"OBJECTIVE Using data from a randomized controlled trial, this study investigated whether parent's consistent use of recommended bedtime strategies with infants was a mediating mechanism for improved child sleep. METHODS Expectant mothers were allocated to 4 groups: usual care (Control); additional support regarding Food, (physical) Activity, and Breastfeeding (FAB); advice on infant sleep through 1 group educational session during the antenatal period and 1 home visit when the child was 3 weeks of age (Sleep), or both FAB and Sleep interventions (Combination). An index relating to parent's consistent use of strategies to encourage infant sleep self-settling was developed from data collected when infants were 4 and 6 months of age. Child sleep self-control was measured at 3.5 years of age through a behavior rating scale. Child overnight sleep duration was measured using accelerometers at 1, 2, 3.5, and 5 years of age. Analyses examined whether any association between intervention group and child sleep self-control or sleep duration was mediated by consistent use of bedtime strategies at 4 and 6 months. RESULTS Compared to Controls, Sleep group parents had significantly higher odds of using more intervention strategies consistently (1.63; 95% confidence interval [CI] 1.14-2.33), as did Combination group parents (1.45; 95% CI 1.01-2.07). Consistent strategy use was significantly associated with a decrease in child bedtime behavioral difficulties (0.97; 95% CI 0.95-0.98) and increased sleep duration (0.152; SE = 0.017). Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies. DISCUSSION Consistent use of appropriate bedtime strategies in infancy is an important factor that influences child sleep self-control in later development.",2019,"Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies. ","['Expectant mothers', 'child sleep']","['usual care (Control); additional support regarding Food, (physical) Activity, and Breastfeeding (FAB); advice on infant sleep through 1 group educational session during the antenatal period and 1 home visit when the child was 3\u202fweeks of age (Sleep), or both FAB and Sleep interventions (Combination']","['child bedtime behavioral difficulties', 'Child overnight sleep duration', 'child sleep self-control difficulties and improved sleep duration', 'Child sleep self-control', 'child sleep self-control or sleep duration', 'sleep duration']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0810924,"Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies. ","[{'ForeName': 'Burt', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago. Electronic address: bhatch@ucdavis.edu.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'Biostatistics Unit, Dunedin School of Medicine, University of Otago.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sayers', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lawrence', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': ""Dean's Department, Dunedin School of Medicine, University of Otago. Electronic address: barry.taylor@otago.ac.nz.""}]",Sleep health,['10.1016/j.sleh.2019.03.002'] 925,31302037,"Remember Me? Exposure to Unfamiliar Food Brands in Television Advertising and Online Advergames Drives Children's Brand Recognition, Attitudes, and Desire to Eat Foods: A Secondary Analysis from a Crossover Experimental-Control Study with Randomization at the Group Level.","BACKGROUND Limitations in current Australian regulatory provisions may be identified by demonstrating the effect of different marketing methods on children's recognition and attitudes toward unhealthy food brands. OBJECTIVE To investigate how exposure to different marketing techniques from television (TV) and online food advertising affects children's brand recall, recognition, and attitudinal responses toward brands and brand consumers and children's desire to eat the advertised products. DESIGN Secondary analysis of data from a crossover experimental-control study. PARTICIPANTS/SETTING In all, 154 children (7 to 12 years) completed the study, conducted at four 6-day holiday camps from April 2016 to January 2017 in New South Wales, Australia. Children were assigned to a single-media (n=76) or multiple-media (n=78) condition. INTERVENTION All children viewed 10 TV food advertisements in a cartoon on three occasions. For one of the brands, one set of children additionally played online ""advergames"" featuring the brand. MAIN OUTCOME MEASURES Children's recognition and attitudes toward brands and brand consumers and children's desire to eat the product were reported via a brand recognition and attitude survey pre- and postintervention. Marketing techniques were categorized. STATISTICAL ANALYSIS Pre- and postintervention brand recognition and relationships between brand recognition and attitudes by media condition and desire to eat the product were examined using generalized linear mixed models and linear mixed models. RESULTS There was a significant increase in the number of brands recognized postexposure by children in both media groups (mean difference=3.8, P<0.0001). The majority of brands appealed to children. Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products. A larger proportion of children who played the advergames (36%) rated brand consumers as ""cool"" than children who viewed the TV advertisements only (19%) (P<0.001). Anti-adult themes, fun and humor, and parent pleasing were techniques unique to some of the most recognized and favored advertisements. CONCLUSIONS The marketing communications increased children's brand recognition and elicited positive attitudinal responses. These findings indicate a need for policy makers to consider additional regulations to protect children from the persuasive influence of unhealthy food advertising.",2020,Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products.,"['154 children (7 to 12 years) completed the study, conducted at four 6-day holiday camps from April 2016 to January 2017 in New South Wales, Australia']","['single-media (n=76) or multiple-media (n=78) condition', 'Unfamiliar Food Brands in Television Advertising and Online Advergames', 'marketing techniques from television (TV) and online food advertising']","[""recognition and attitudes toward brands and brand consumers and children's desire to eat the product were reported via a brand recognition and attitude survey pre- and postintervention"", ""children's brand recognition and elicited positive attitudinal responses"", 'number of brands recognized postexposure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442552', 'cui_str': 'Vacation camp'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",154.0,0.0291987,Children who reported wanting to eat the advertised products rated brands more positively than children who did not express a desire to eat the products.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Norman', 'Affiliation': ''}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Anne-T', 'Initials': 'AT', 'LastName': 'McMahon', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Boyland', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'King', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.006'] 926,31296491,"NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial.","BACKGROUND Pathological complete response to preoperative treatment in adults with soft-tissue sarcoma can be achieved in only a few patients receiving radiotherapy. This phase 2-3 trial evaluated the safety and efficacy of the hafnium oxide (HfO 2 ) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone as a pre-operative treatment in patients with locally advanced soft-tissue sarcoma. METHODS Act.In.Sarc is a phase 2-3 randomised, multicentre, international trial. Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included. Patients had to have a WHO performance status of 0-2 and a life expectancy of at least 6 months. Patients were randomly assigned (1:1) by an interactive web response system to receive either NBTXR3 (volume corresponding to 10% of baseline tumour volume at a fixed concentration of 53·3 g/L) as a single intratumoural administration before preoperative external-beam radiotherapy (50 Gy in 25 fractions) or radiotherapy alone, followed by surgery. Randomisation was stratified by histological subtype (myxoid liposarcoma vs others). This was an open-label study. The primary endpoint was the proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines in the intention-to-treat population full analysis set. Safety analyses were done in all patients who received at least one puncture and injection of NBTXR3 or at least one dose of radiotherapy. This study is registered with ClinicalTrials.gov, number NCT02379845, and is ongoing for long-term follow-up, but recruitment is complete. FINDINGS Between March 3, 2015, and Nov 21, 2017, 180 eligible patients were enrolled and randomly assigned and 179 started treatment: 89 in the NBTXR3 plus radiotherapy group and 90 in the radiotherapy alone group. Two patients in the NBTXR3 group and one patient in the radiotherapy group were excluded from the efficacy analysis because they were subsequently discovered to be ineligible; thus, a total of 176 patients were analysed for the primary endpoint in the intention-to-treat full analysis set (87 in the NBTXR3 group and 89 in the radiotherapy alone group). A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044). In both treatment groups, the most common grade 3-4 treatment-emergent adverse event was postoperative wound complication (eight [9%] of 89 patients in the NBTXR3 group and eight [9%] of 90 in the radiotherapy alone group). The most common grade 3-4 adverse events related to NBTXR3 administration were injection site pain (four [4%] of 89) and hypotension (four [4%]) and the most common grade 3-4 radiotherapy-related adverse event was radiation skin injury in both groups (five [6%] of 89 in the NBTXR3 group and four [4%] of 90 in the radiotherapy alone group). The most common treatment-emergent grade 3-4 adverse event related to NBTXR3 was hypotension (six [7%] of 89 patients). Serious adverse events were observed in 35 (39%) of 89 patients in the NBTXR3 group and 27 (30%) of 90 patients in the radiotherapy alone group. No treatment-related deaths occurred. INTERPRETATION This trial validates the mode of action of this new class of radioenhancer, which potentially opens a large field of clinical applications in soft-tissue sarcoma and possibly other cancers. FUNDING Nanobiotix SA.",2019,A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044).,"['adults with soft-tissue sarcoma', 'Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included', 'patients with locally advanced soft-tissue sarcoma (Act', 'patients with locally advanced soft-tissue sarcoma', 'Between March 3, 2015, and Nov 21, 2017, 180 eligible patients were enrolled and randomly assigned and 179 started treatment: 89 in the', 'Patients had to have a WHO performance status of 0-2 and a life expectancy of at least 6 months']","['radiotherapy versus radiotherapy alone', 'NBTXR3 plus radiotherapy', 'NBTXR3', 'radiotherapy', 'hafnium oxide (HfO 2 ) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone']","['postoperative wound complication', 'proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines', 'hypotension', 'Serious adverse events', 'pathological complete response', 'injection site pain', 'safety and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2742307', 'cui_str': 'hafnium oxide'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",180.0,0.171668,A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044).,"[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgery, Institut Curie, PSL Research University, Paris, France. Electronic address: sylvie.bonvalot@curie.fr.'}, {'ForeName': 'Piotr L', 'Initials': 'PL', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute-Oncology Center, Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Department of Radiation Oncology, Centre François Baclesse, Caen, France; Department of Radiation Oncology, Centre Lacassagne, Nice, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Carrère', 'Affiliation': 'Department of Surgical Oncology, Centre Regional De Lutte Contre Le Cancer Paul Lamarque, Montpellier, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ducassou', 'Affiliation': 'Department of Radiation Oncology, Institut Claudius Regaud (ICR), Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O), Toulouse, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Sunyach', 'Affiliation': 'Department of Radiotherapy, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Agoston', 'Affiliation': 'Department of Radiation Oncology, Országos Onkologiai Intézet, Budapest, Hungary.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': ""Department of Radiation Oncology, Chris O'Brien Lifehouse and The University of Sydney, Camperdown, NSW, Australia.""}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Mervoyer', 'Affiliation': ""Department of Radiation Oncology, Institut de Cancerologie de l'Ouest- Rene Gauducheau, Saint-Herblain, France.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Surgical Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Oncology, Hospital Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Rubi K', 'Initials': 'RK', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, St Luke's Medical Center, Quezon City, Philippines.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Tiangco', 'Affiliation': 'Department of Medical Oncology, The Medical City Cancer Center, Pasay City, Philippines.'}, {'ForeName': 'Antonio Casado', 'Initials': 'AC', 'LastName': 'Herraez', 'Affiliation': 'Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': 'Department of Oncotherapy, University of Pecs, Pecs, Hungary.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sy-Ortin', 'Affiliation': 'Department of Radiation Oncology, Benavides Cancer Institute, University of Santo Tomas Hospital, Manila, Philippines.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, Division of Surgical Oncology and Thoracic Surgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'de Baère', 'Affiliation': 'Department of Interventional Radiology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Helfre', 'Affiliation': 'Department of Radiation Therapy, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': 'Department of Medical Oncology, Centre Anticancer Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Borkowska', 'Affiliation': 'Department of Radiotherapy, Maria Sklodowska-Curie Institute-Oncology Center, Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Anghel', 'Affiliation': 'Institutul Oncologic Bucuresti Prof Dr Alexandru Trestioreanu, Bucharest, Romania.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Co', 'Affiliation': 'Cebu Cancer Institute, Perpetual Succour Hospital, Cebu City, Philippines.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gebhart', 'Affiliation': 'Department of Orthopedic Surgery, ULB, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Kantor', 'Affiliation': 'Department of Radiotherapy, Institut Bergonié, Comprehensive Cancer Center, Bordeaux, France.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Montero', 'Affiliation': 'Radiation Oncology Department, Hospital HM Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Loong', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, Sha Tin, Hong Kong.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Vergés', 'Affiliation': ""Radiation Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Lapeire', 'Affiliation': 'Department of Medical Oncology, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Dema', 'Affiliation': 'Municipal Emergency Hospital Timisoara, Timisoara, Romania.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kacso', 'Affiliation': 'Iuliu Hatieganu Medical University, RTC Amethyst, Cluj, Romania.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Austen', 'Affiliation': 'Department of Radiation Oncology, Canberra Region Cancer Centre, Garran, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': 'Department of Radiation-Oncology, Institut Paoli Calmettes, Marseille Cedex, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Servois', 'Affiliation': 'Department of Radiology, Institut Curie, PSL Research University, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard Domagk Institute of Pathology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Terrier', 'Affiliation': 'Gustave Roussy, Cancer Campus, Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Lazar', 'Affiliation': 'Departments of Pathology & Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Judith V M G', 'Initials': 'JVMG', 'LastName': 'Bovée', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy-Cancer Campus, Villejuif, France.'}, {'ForeName': 'Zsusanna', 'Initials': 'Z', 'LastName': 'Papai', 'Affiliation': 'Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30326-2'] 927,31300331,"Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial.","BACKGROUND Results from a previous phase 3 study showed efficacy of the RTS,S/AS01 vaccine against severe and clinical malaria in children (in 11 sites in Africa) during a 3-4-year follow-up. We aimed to investigate malaria incidence up to 7 years postvaccination in three of the sites of the initial study. METHODS In the initial phase 3 study, infants aged 6-12 weeks and children aged 5-17 months were randomly assigned (1:1:1) to receive four RTS,S/AS01 doses (four-dose group), three RTS,S/AS01 doses and a comparator dose (three-dose group), or four comparator doses (control group). In this open-label extension study in Korogwe (Tanzania), Kombewa (Kenya), and Nanoro (Burkina Faso), we assessed severe malaria incidences as the primary outcome for 3 additional years (January, 2014, to December, 2016), up to 6 years (younger children) or 7 years (older children) postprimary vaccination in the modified intention-to-treat population (ie, participants who received at least one dose of the study vaccine). As secondary outcomes, we evaluated clinical malaria incidences and serious adverse events. This trial is registered with ClinicalTrials.gov, number NCT02207816. FINDINGS We enrolled 1739 older children (aged 5-7 years) and 1345 younger children (aged 3-5 years). During the 3-year extension, 66 severe malaria cases were reported, resulting in severe malaria incidence of 0·004 cases per person-years at risk (PPY; 95% CI 0-0·033) in the four-dose group, 0·007 PPY (0·001-0·052) in the three-dose group, and 0·009 PPY (0·001-0·066) in the control group in the older children category and a vaccine efficacy against severe malaria that did not contribute significantly to the overall efficacy (four-dose group 53·7% [95% CI -13·7 to 81·1], p=0·093; three-dose group 23·3% [-67·1 to 64·8], p=0·50). In younger children, severe malaria incidences were 0·007 PPY (0·001-0·058) in the four-dose group, 0·007 PPY (0·001-0·054) in the three-dose group, and 0·011 PPY (0·001-0·083) in the control group. Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27). Malaria transmission was still occurring as evidenced by an incidence of clinical malaria ranging from 0·165 PPY to 3·124 PPY across all study groups and sites. In older children, clinical malaria incidence was 1·079 PPY (95% CI 0·152-7·662) in the four-dose group, 1·108 PPY (0·156-7·868) in the three-dose group, and 1·016 PPY (0·14-7·213) in the control group. In younger children, malaria incidence was 1·632 PPY (0·23-11·59), 1·563 PPY (0·22-11·104), and 1·686 PPY (0·237-11·974), respectively. In the older age category in Nanoro, clinical malaria incidence was higher in the four-dose (2·444 PPY; p=0·011) and three-dose (2·411 PPY; p=0·034) groups compared with the control group (1·998 PPY). Three cerebral malaria episodes and five meningitis cases, but no vaccine-related severe adverse events, were reported. INTERPRETATION Overall, severe malaria incidence was low in all groups, with no evidence of rebound in RTS,S/AS01 recipients, despite an increased incidence of clinical malaria in older children who received RTS,S/AS01 compared with the comparator group in Nanoro. No safety signal was identified. FUNDING GlaxoSmithKline Biologicals SA.",2019,"Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27).","['3 additional years (January, 2014, to December, 2016), up to 6 years (younger children) or 7 years (older children) postprimary vaccination in the modified intention-to-treat population (ie, participants who received at least one dose of the study vaccine', '1739 older children (aged 5-7 years) and 1345 younger children (aged 3-5 years', 'infants aged 6-12 weeks and children aged 5-17 months', 'children and infants in Africa', 'children (in 11 sites in Africa']","['RTS,S/AS01 vaccination', 'RTS,S/AS01 vaccine']","['clinical malaria incidences and serious adverse events', 'clinical malaria incidence', 'cerebral malaria episodes', 'severe malaria incidence', 'severe malaria incidences', 'clinical malaria', 'vaccine efficacy against severe malaria', 'overall efficacy', 'malaria incidence']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1739.0,0.113118,"Vaccine efficacy against severe malaria also did not contribute significantly to the overall efficacy (four-dose group 32·1% [-53·1 to 69·9], p=0·35; three-dose group 37·6% [-44·4 to 73·0], p=0·27).","[{'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Otieno', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Gesase', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Otieno', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Liheluka', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valéa', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': ""Sing'oei"", 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Anangisye', 'Initials': 'A', 'LastName': 'Malabeja', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Valia', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wangwe', 'Affiliation': 'Walter Reed Project, Kenya Medical Research Institute, US Medical Research Directorate, Kombewa, Kenya.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gvozdenovic', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Guerra Mendoza', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso. Electronic address: marc.lievens@gsk.com.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lusingu', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30300-7'] 928,31296588,"Effects of vitamin D supplementation on cognitive function and blood Aβ-related biomarkers in older adults with Alzheimer's disease: a randomised, double-blind, placebo-controlled trial.","OBJECTIVE Our study aimed to assess the effect of a 12-month vitamin D supplementation on cognitive function and amyloid beta (Aβ)-related biomarkers in subjects with Alzheimer's disease (AD). METHODS : This was a randomised, double-blind, placebo-controlled trial. 210 AD patients were randomly divided into intervention and control groups. Participants received 12-month 800 IU/day of vitamin D or starch granules as placebo. Tests of cognitive performance and Aβ-related biomarkers were measured at baseline, 6 months and 12 months. RESULTS : Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group. According to mixed-model analysis, vitamin D group had significant increase in full scale IQ during follow-up period (p<0.001). CONCLUSIONS Daily oral vitamin D supplementation (800 IU/day) for 12 months may improve cognitive function and decrease Aβ-related biomarkers in elderly patients with AD. Larger scale longer term randomised trials of vitamin D are needed. TRIAL REGISTRATION NUMBER ChiCTR-IIR-16009549.",2019,"Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group.","[""older adults with Alzheimer's disease"", 'elderly patients with AD', '210 AD patients', ""subjects with Alzheimer's disease (AD""]","['vitamin D supplementation', 'vitamin D', 'placebo', 'vitamin D or starch granules as placebo']","['cognitive performance and Aβ-related biomarkers', 'full scale IQ', 'plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores', 'cognitive function and blood Aβ-related biomarkers', 'cognitive function', 'cognitive function and amyloid beta ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0222045'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",,0.755744,"Repeated-measures analysis of variance showed significant improvements in plasma Aβ42, APP, BACE1, APPmRNA, BACE1mRNA (p<0.001) levels and information, arithmetic, digit span, vocabulary, block design and picture arrange scores (p<0.05) in the intervention group over the control group.","[{'ForeName': 'Jingya', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xiaoxu', 'Initials': 'X', 'LastName': 'Huo', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Rujuan', 'Initials': 'R', 'LastName': 'Miao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health,Tianjin Medical University, Tianjin, China mf2002245mf@aliyun.com.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-320199'] 929,31281938,Effects of Exercise Intervention Program on Bone Mineral Accretion in Children and Adolescents with Cystic Fibrosis: A Randomized Controlled Trial.,"OBJECTIVE To evaluate effect of one year exercise intervention program on bone mineral accrual in children and adolescent with cystic fibrosis (CF). METHODS Fifty-two CF children (mean age 149.79 mo) were randomized into experimental (15 boys and 10 girls) and control groups (15 boys and 12 girls). Experimental group performed prescribed exercises three times/week, while control group continued with routine physical activities for one year. Following were assessed at baseline and at one year: Bone mineral density (BMD) of whole body and lumbar spine, pulmonary function, exercise capacity, quality of life and habitual activity. RESULTS Change in whole body and lumbar spine BMD over 12 mo in experimental group was lower by 0.006 g/cm 2 (95% CI -0.02 to 0.02) and higher by 0.001 g/cm 2 (95% CI -0.04 to 0.03) than controls, respectively. However, difference between groups was non-significant for both parameters. Experimental group had a significant improvement in their exercise capacity (p = 0.006), quality of life, and serum vitamin D (p = 0.007) levels. Differences between groups for changes in pulmonary function and habitual activity were non-significant. CONCLUSIONS Exercise regime was not associated with significant improvement in BMD of CF patients, but it had a positive impact on both physical and psychological health of these patients.",2019,"Experimental group had a significant improvement in their exercise capacity (p = 0.006), quality of life, and serum vitamin D (p = 0.007) levels.","['children and adolescent with cystic fibrosis (CF', 'Children and Adolescents with Cystic Fibrosis', 'Fifty-two CF children (mean age 149.79 mo) were randomized into experimental (15 boys and 10 girls) and control groups (15 boys and 12 girls']","['exercise intervention program', 'Exercise Intervention Program']","['quality of life, and serum vitamin D', 'BMD', 'lumbar spine BMD', 'pulmonary function and habitual activity', 'exercise capacity', 'Bone Mineral Accretion', 'Bone mineral density (BMD) of whole body and lumbar spine, pulmonary function, exercise capacity, quality of life and habitual activity', 'bone mineral accrual']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]",52.0,0.0390589,"Experimental group had a significant improvement in their exercise capacity (p = 0.006), quality of life, and serum vitamin D (p = 0.007) levels.","[{'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Madhulika', 'Initials': 'M', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Kishore K', 'Initials': 'KK', 'LastName': 'Deepak', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Talwar', 'Affiliation': 'Department of Physiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushil Kumar', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India. skkabra@hotmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-019-03019-x'] 930,28485643,Effects of line dancing on physical function and perceived limitation in older adults with self-reported mobility limitations.,"INTRODUCTION Older adults with mobility limitations are at greater risk for aging-related declines in physical function. Line dancing is a popular form of exercise that can be modified, and is thus feasible for older adults with mobility limitations. PURPOSE The purpose of this study was to assess the effects of 8 weeks of line dancing on balance, muscle strength, lower extremity function, endurance, gait speed, and perceived mobility limitations. METHODS An experimental design randomly assigned older adults to either an 8-week line dancing or usual care group. The convenience sample consisted of 23 participants with mobility limitations (age range: 65-93 years). The intervention used simple routines from novice line dance classes. At baseline and at 8 weeks, balance, knee muscle strength, lower extremity function, endurance, gait speed, and mobility limitations were measured. ANCOVA tests were conducted on each dependent variable to assess the effects of the intervention over time. RESULTS Results found significant positive differences for the intervention group in lower extremity function (p < 0.01); endurance (p < 0.01); gait speed (p < 0.001); and self-reported mobility limitations (p < 0.05). CONCLUSIONS Eight weeks of line dancing significantly improved physical function and reduced self-reported mobility limitations in these individuals. Line dancing could be recommended by clinicians as a potential adjunct therapy that addresses mobility limitations. Implications for Rehabilitation Line dancing may be an alternative exercise for older adults who need modifications due to mobility limitations. Line dancing incorporates cognitive and motor control. Line dancing can be performed alone or in a group setting. Dancing improves balance which can reduce risk of falls.",2018,"RESULTS Results found significant positive differences for the intervention group in lower extremity function (p < 0.01); endurance (p < 0.01); gait speed (p < 0.001); and self-reported mobility limitations (p < 0.05). ","['23 participants with mobility limitations (age range: 65-93\u2009years', 'older adults with self-reported mobility limitations', 'older adults with mobility limitations', 'older adults']","['8-week line dancing or usual care group', 'line dancing']","['physical function and reduced self-reported mobility limitations', 'balance, knee muscle strength, lower extremity function, endurance, gait speed, and mobility limitations', 'gait speed', 'lower extremity function', 'self-reported mobility limitations', 'balance, muscle strength, lower extremity function, endurance, gait speed, and perceived mobility limitations']","[{'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4046018', 'cui_str': 'Line Dancing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",23.0,0.0178559,"RESULTS Results found significant positive differences for the intervention group in lower extremity function (p < 0.01); endurance (p < 0.01); gait speed (p < 0.001); and self-reported mobility limitations (p < 0.05). ","[{'ForeName': 'Crystal G', 'Initials': 'CG', 'LastName': 'Bennett', 'Affiliation': 'a School of Nursing , University of West Florida , Pensacola , USA.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Hackney', 'Affiliation': 'b Atlanta VA Medical Center, Center for Visual & Neurocognitive Rehabilitation , Atlanta , USA.'}]",Disability and rehabilitation,['10.1080/09638288.2017.1294207'] 931,28467869,Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis.,"BACKGROUND Tofacitinib, an oral, small-molecule Janus kinase inhibitor, was shown to have potential efficacy as induction therapy for ulcerative colitis in a phase 2 trial. We further evaluated the efficacy of tofacitinib as induction and maintenance therapy. METHODS We conducted three phase 3, randomized, double-blind, placebo-controlled trials of tofacitinib therapy in adults with ulcerative colitis. In the OCTAVE Induction 1 and 2 trials, 598 and 541 patients, respectively, who had moderately to severely active ulcerative colitis despite previous conventional therapy or therapy with a tumor necrosis factor antagonist were randomly assigned to receive induction therapy with tofacitinib (10 mg twice daily) or placebo for 8 weeks. The primary end point was remission at 8 weeks. In the OCTAVE Sustain trial, 593 patients who had a clinical response to induction therapy were randomly assigned to receive maintenance therapy with tofacitinib (either 5 mg or 10 mg twice daily) or placebo for 52 weeks. The primary end point was remission at 52 weeks. RESULTS In the OCTAVE Induction 1 trial, remission at 8 weeks occurred in 18.5% of the patients in the tofacitinib group versus 8.2% in the placebo group (P=0.007); in the OCTAVE Induction 2 trial, remission occurred in 16.6% versus 3.6% (P<0.001). In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5-mg tofacitinib group and 40.6% in the 10-mg tofacitinib group versus 11.1% in the placebo group (P<0.001 for both comparisons with placebo). In the OCTAVE Induction 1 and 2 trials, the rates of overall infection and serious infection were higher with tofacitinib than with placebo. In the OCTAVE Sustain trial, the rate of serious infection was similar across the three treatment groups, and the rates of overall infection and herpes zoster infection were higher with tofacitinib than with placebo. Across all three trials, adjudicated nonmelanoma skin cancer occurred in five patients who received tofacitinib and in one who received placebo, and adjudicated cardiovascular events occurred in five who received tofacitinib and in none who received placebo; as compared with placebo, tofacitinib was associated with increased lipid levels. CONCLUSIONS In patients with moderately to severely active ulcerative colitis, tofacitinib was more effective as induction and maintenance therapy than placebo. (Funded by Pfizer; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain ClinicalTrials.gov numbers, NCT01465763 , NCT01458951 , and NCT01458574 , respectively.).",2017,"In the OCTAVE Induction 1 and 2 trials, the rates of overall infection and serious infection were higher with tofacitinib than with placebo.","['598 and 541 patients, respectively, who had moderately to severely active ulcerative colitis despite previous conventional therapy or therapy with a tumor necrosis factor antagonist', 'Ulcerative Colitis', 'adults with ulcerative colitis', '593 patients who had a clinical response to induction therapy']","['tofacitinib', 'induction therapy with tofacitinib', 'placebo', 'tofacitinib therapy', 'placebo, tofacitinib', 'Tofacitinib', 'maintenance therapy with tofacitinib']","['rates of overall infection and herpes zoster infection', 'remission', 'rate of serious infection', 'adjudicated nonmelanoma skin cancer', 'rates of overall infection and serious infection', 'adjudicated cardiovascular events', 'lipid levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4510395', 'cui_str': 'Tofacitinib therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}]",593.0,0.73436,"In the OCTAVE Induction 1 and 2 trials, the rates of overall infection and serious infection were higher with tofacitinib than with placebo.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Niezychowski', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Friedman', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Nervin', 'Initials': 'N', 'LastName': 'Lawendy', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Dahong', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Woodworth', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Healey', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1606910'] 932,31280410,Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial.,"OBJECTIVE To compare the incidence of hyponatremia during the first 48 h in hospitalized children receiving normal saline vs. N/2 saline as maintenance intravenous fluid. METHODS This open label, randomized controlled trial to compare the incidence of hyponatremia in hospitalized children receiving normal saline (0.9% sodium chloride in 5% dextrose) vs. N/2 saline (0.45% sodium chloride in 5% dextrose) as maintenance fluid was conducted from December 2014 through November 2015 in a tertiary care teaching hospital. Children between 1 mo and 18 y requiring maintenance intravenous fluids were randomized to receive normal saline with 5% dextrose (n = 75) or N/2 saline with 5% dextrose (n = 75). RESULTS Both groups were comparable for demographic variables and illness severity at baseline. Incidence of hyponatremia at 24 h of hospitalization was comparable between normal saline and N/2 saline group, 3(4%) vs. 6(8%) cases, respectively; p value 0.494. Mean serum sodium levels were marginally higher in normal saline group (138.3 ± 6.0 mEq/L) as compared with N/2 saline group (135.1 ± 4.4 mEq/L) (p value <0.01) at 24 h of hospitalization. Incidence of hyponatremia at 48 h and hypernatremia at 24 and 48 h was comparable in two groups. CONCLUSIONS The use of either N/2 saline or normal saline in sick children at standard maintenance fluid rates is associated with low but comparable incidence of hypo or hypernatremia in first 24 h of hospitalization. Both types of fluids appear acceptable in hospitalized sick children.",2019,Mean serum sodium levels were marginally higher in normal saline group (138.3 ± 6.0 mEq/L) as compared with N/2 saline group (135.1 ± 4.4 mEq/L) (p value <0.01) at 24 h of hospitalization.,"['hospitalized children receiving', 'hospitalized sick children', 'Children between 1 mo and 18 y requiring maintenance intravenous fluids', 'December 2014 through November 2015 in a tertiary care teaching hospital', 'Children']","['N/2 saline or normal saline', 'normal saline with 5% dextrose (n\u2009=\u200975) or N/2 saline with 5% dextrose', 'normal saline (0.9% sodium chloride in 5% dextrose) vs. N/2 saline (0.45% sodium chloride in 5% dextrose', 'Isotonic versus Hypotonic Intravenous Maintenance Fluids', 'normal saline vs. N/2 saline']","['Incidence of hyponatremia', 'Incidence of hyponatremia at 24\xa0h of hospitalization', 'Mean serum sodium levels']","[{'cui': 'C0008098', 'cui_str': 'Child, Hospitalized'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}]",,0.618483,Mean serum sodium levels were marginally higher in normal saline group (138.3 ± 6.0 mEq/L) as compared with N/2 saline group (135.1 ± 4.4 mEq/L) (p value <0.01) at 24 h of hospitalization.,"[{'ForeName': 'Narendra K', 'Initials': 'NK', 'LastName': 'Bagri', 'Affiliation': 'Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Vidya K', 'Initials': 'VK', 'LastName': 'Saurabh', 'Affiliation': 'Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. ashokkumar_bhu@hotmail.com.'}]",Indian journal of pediatrics,['10.1007/s12098-019-03011-5'] 933,31281091,Measuring Patient Preferences and Clinic Follow-Up Utilizing an Embedded Discharge Appointment Scheduler: A Pilot Study.,"BACKGROUND Scheduling timely outpatient follow-up appointments is part of a high-quality discharge process. In many centers, residents and hospitalists schedule follow-up appointments, often without patient input due to time constraints. METHODS A needs assessment was conducted to quantify clinician time spent making discharge appointments and to identify barriers to successful appointment scheduling. A four-week pilot intervention subsequently embedded a discharge scheduler responsible for scheduling discharge appointments into five house staff teams. The goals of the pilot were to incorporate patients' scheduling preferences when making appointments, to improve appointment attendance, and to reduce administrative burden on residents. Results were analyzed using chi-square and Fisher's exact tests. RESULTS Patients expressed a strong preference to be involved in scheduling follow-up appointments. In the intervention, there was a statistically significant increase in successfully scheduled appointments (66.7% vs. 87.7%; p < 0.0001) and attendance at follow-up appointments (43.9% baseline vs. 62.9% intervention; p = 0.011), a statistically significant reduction in rescheduled appointments (16.7% baseline vs. 4.9% intervention; p = 0.008), a nonsignificant trend toward increased number of canceled appointments (7.6% baseline vs. 17.5% intervention; p = 0.088), and no significant difference in no-show rates (18.2% baseline vs. 14.7% intervention; p = 0.544). Of residents involved in the pilot, 100% reported that the scheduler improved their ability to care for patients. CONCLUSION This pilot suggests that adding a nonclinical team member tasked with scheduling discharge appointments improved alignment of the discharge process with patients' preferences and may be of value to residents, hospitalists, and the health care system.",2019,"In the intervention, there was a statistically significant increase in successfully scheduled appointments (66.7% vs. 87.7%; p < 0.0001) and attendance at follow-up appointments (43.9% baseline vs. 62.9% intervention; p = 0.011), a statistically significant reduction in rescheduled appointments (16.7% baseline vs. 4.9% intervention; p = 0.008), a nonsignificant trend toward increased number of canceled appointments (7.6% baseline vs. 17.5% intervention; p = 0.088), and no significant difference in no-show rates (18.2% baseline vs. 14.7% intervention; p = 0.544).",[],[],"['successfully scheduled appointments', 'number of canceled appointments', 'attendance']",[],[],"[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205544', 'cui_str': 'Canceled (qualifier value)'}]",,0.043032,"In the intervention, there was a statistically significant increase in successfully scheduled appointments (66.7% vs. 87.7%; p < 0.0001) and attendance at follow-up appointments (43.9% baseline vs. 62.9% intervention; p = 0.011), a statistically significant reduction in rescheduled appointments (16.7% baseline vs. 4.9% intervention; p = 0.008), a nonsignificant trend toward increased number of canceled appointments (7.6% baseline vs. 17.5% intervention; p = 0.088), and no significant difference in no-show rates (18.2% baseline vs. 14.7% intervention; p = 0.544).","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Gace', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Finn', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2019.05.007'] 934,31281181,Thyroid hormone and folinic acid in young children with Down syndrome: the phase 3 ACTHYF trial.,"PURPOSE To determine whether folinic acid (FA) and thyroxine, in combination or alone, benefit psychomotor development in young patients with Down syndrome (DS). METHODS The Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children (ACTHYF) was a single-center, randomized, double-blind, placebo-controlled phase 3 trial in DS infants aged 6-18 months. Patients were randomly assigned to one of four treatments: placebo, folinic acid (FA), L-thyroxine, or FA+L-thyroxine, administered for 12 months. Randomization was done by age and sex. The primary endpoint was adjusted change from baseline in Griffiths Mental Development Scale global development quotient (GDQ) after 12 months. RESULTS Of 175 patients randomized, 143 completed the study. The modified intention-to-treat (mITT) population included all randomized patients who did not prematurely discontinue due to elevated baseline thyroid stimulating hormone (TSH). Baseline characteristics in the mITT were well balanced between groups, with reliable developmental assessment outcomes. Adjusted mean change in GDQ in the mITT showed similar decreases in all groups (placebo: -5.10 [95% confidence interval (CI) -7.84 to -2.37]; FA: -4.69 [95% CI -7.73 to -1.64]; L-thyroxine: -3.89 [95% CI -6.94 to -0.83]; FA+L-thyroxine: -3.86 [95% CI -6.67 to -1.06]), with no significant difference for any active treatment group versus placebo. CONCLUSION This trial does not support the hypotheses that thyroxine and/or folinic acid improve development of young children with DS or are synergistic. This trial is registered with ClinicalTrials.gov number, NCT01576705.",2020,Adjusted mean change in GDQ in the mITT showed similar decreases in all groups (placebo: -5.10 [95% confidence interval (CI) -7.84 to -2.37]; FA: -4.69,"['175 patients randomized', 'young patients with Down syndrome (DS', 'young children with Down syndrome', 'population included all randomized patients who did not prematurely discontinue due to elevated baseline thyroid stimulating hormone (TSH', 'young children with DS', 'controlled phase 3 trial in DS infants aged 6-18 months']","['modified intention-to-treat (mITT', 'folinic acid (FA) and thyroxine, in combination or alone', 'placebo', 'thyroxine and/or folinic acid', 'Folinic Acid and Thyroid Hormone', 'placebo, folinic acid\xa0(FA), L-thyroxine, or FA+L-thyroxine', 'Thyroid hormone and folinic acid']","['adjusted change from baseline in Griffiths Mental Development Scale global development quotient (GDQ', 'GDQ']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",175.0,0.694716,Adjusted mean change in GDQ in the mITT showed similar decreases in all groups (placebo: -5.10 [95% confidence interval (CI) -7.84 to -2.37]; FA: -4.69,"[{'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Mircher', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France. clotilde.mircher@institutlejeune.org.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sacco', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bouis', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gallard', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Pichot', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Le Galloudec', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Cieuta', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Marey', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Greiner-Mahler', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dorison', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gambarini', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Stora', 'Affiliation': 'Institut Jérôme Lejeune Biobank BioJeL, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Durand', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Endocrinologie gynécologie diabétologie pédiatriques, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, INSERM U1016, Institut IMAGINE, Paris, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Baruchel', 'Affiliation': 'Pediatric Hematology-Immunology Department, University Hospital Robert Debré, Assistance Publique-Hôpitaux de Paris. Paris Diderot University, EA 3518; Institute of Hematology, Sorbonne Paris-Cité, Paris, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Schlumberger', 'Affiliation': 'Reference Center for Language and Learning Disorders, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris, Garches, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dewailly', 'Affiliation': 'Bluestat Statistical Company, Garches, France.'}, {'ForeName': 'Ahlam', 'Initials': 'A', 'LastName': 'Azar-Kolakez', 'Affiliation': 'Endocrinology-Diabetology Department, Reference Center for Endocrine Growth and Developmental Disease, Robert Debré Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Rosa-Maria', 'Initials': 'RM', 'LastName': 'Guéant-Rodriguez', 'Affiliation': 'Research Unit (Inserm) UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), University de Lorraine, Faculty of Medicine, Nancy, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Guéant', 'Affiliation': 'Research Unit (Inserm) UMRS 1256 N-GERE (Nutrition-Genetics-Environmental Risks), University de Lorraine, Faculty of Medicine, Nancy, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Borderie', 'Affiliation': 'Biochemistry and Molecular Biology Laboratory, Cochin University Hospital, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bonnefont-Rousselot', 'Affiliation': 'Metabolic Biochemistry Department, Pitié-Salpêtrière-Charles Foix University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Blondiaux', 'Affiliation': 'Department of Statistics, Effi-Stat, Paris, France.'}, {'ForeName': 'Aimé', 'Initials': 'A', 'LastName': 'Ravel', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}, {'ForeName': 'Franck G', 'Initials': 'FG', 'LastName': 'Sturtz', 'Affiliation': 'Institut Jérôme Lejeune, Paris, France.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0597-8'] 935,31285147,"Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial.","BACKGROUND Opicinumab is a human monoclonal antibody against LINGO-1, an inhibitor of oligodendrocyte differentiation and axonal regeneration. Previous findings suggested that opicinumab treatment might enhance remyelination in patients with CNS demyelinating diseases. We aimed to assess the safety and efficacy of opicinumab in patients with relapsing multiple sclerosis. METHODS We did a randomised, double-blind, placebo-controlled, dose-ranging, phase 2 study (SYNERGY) at 72 sites in 12 countries. Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses) were randomised in a 1:2:2:2:2 ratio by an interactive voice and web response system to opicinumab 3 mg/kg, 10 mg/kg, 30 mg/kg, or 100 mg/kg, or placebo. An identical volume of study drug was administered intravenously once every 4 weeks. All participants self-administered intramuscular interferon beta-1a as background anti-inflammatory treatment once a week. The primary endpoint was the percentage of participants achieving confirmed disability improvement over 72 weeks, which was a multicomponent endpoint measured by the Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test. The primary endpoint was analysed under intention-to-treat principles. This study is registered at ClinicalTrials.gov, number NCT01864148. FINDINGS Between Aug 13, 2013, and July 31, 2014, 419 patients were enrolled and randomly assigned either placebo (n=93) or opicinumab 3 mg/kg (n=45), 10 mg/kg (n=95), 30 mg/kg (n=94; one patient did not receive the assigned treatment), or 100 mg/kg (n=92). The last patient visit was on March 29, 2016. Confirmed disability improvement over 72 weeks was seen in 45 (49%) of 91 patients assigned to placebo, 21 (47%) of 45 assigned to opicinumab 3 mg/kg, 59 (63%) of 94 assigned to opicinumab 10 mg/kg, 59 (65%) of 91 assigned to opicinumab 30 mg/kg, and 36 (40%) of 91 assigned to opicinumab 100 mg/kg. A linear dose-response in the probability of confirmed disability improvement was not seen (linear trend test p=0·89). Adverse events occurred in 79 (85%) patients assigned placebo and in 275 (85%) assigned any dose of opicinumab. The most common adverse events of any grade in patients assigned any dose of opicinumab included influenza-like illness (140 [43%] with any dose of opicinumab vs 37 [40%] with placebo), multiple sclerosis relapses (117 [36%] vs 30 [32%]), and headache (51 [16%] vs 23 [25%]). Serious adverse events reported as related to treatment were urinary tract infection in one (1%) participant in the the placebo group, suicidal ideation and intentional overdose in one (1%) participant in the 30 mg/kg opicinumab group, bipolar disorder in one (1%) participant in the 100 mg/kg opicinumab group, and hypersensitivity in four (4%) participants in the 100 mg/kg opicinumab group. One patient in the opicinumab 30 mg/kg group died during the study due to a traffic accident, which was not considered related to study treatment. INTERPRETATION Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis. Further studies are needed to investigate whether some subpopulations identified in the study might benefit from opicinumab treatment at an optimum dose. FUNDING Biogen.",2019,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"['patients with relapsing multiple sclerosis', 'patients with relapsing multiple sclerosis (SYNERGY', 'patients with CNS demyelinating diseases', '419 patients', 'Between Aug 13, 2013, and July 31, 2014', '72 sites in 12 countries', 'Participants (aged 18-58 years) with relapsing multiple sclerosis (relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis with relapses']","['opicinumab 3 mg/kg', 'placebo', 'opicinumab']","['Expanded Disability Status Scale, the Timed 25-Foot Walk, the Nine-Hole Peg Test, and the 3 s Paced Auditory Serial Addition Test', 'safety and efficacy', 'under intention-to-treat principles', 'Adverse events', 'disability', 'percentage of participants achieving confirmed disability improvement', 'hypersensitivity', 'urinary tract infection', 'bipolar disorder', 'headache', 'influenza-like illness', 'suicidal ideation and intentional overdose', 'multiple sclerosis relapses', 'disability improvement', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011303', 'cui_str': 'Demyelinating Disorders'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C4550038', 'cui_str': 'opicinumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0520804', 'cui_str': 'Intentional drug overdose (disorder)'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]",419.0,0.496337,Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis.,"[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cadavid', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mellion', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hupperts', 'Affiliation': 'Zuyderland Medical Center, Sittard, Netherlands.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Edwards', 'Affiliation': 'Multiple Sclerosis Center of Northeastern New York, Latham, NY, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Calabresi', 'Affiliation': 'The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Drulović', 'Affiliation': 'Clinic of Neurology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts & The London School of Medicine & Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Mi', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Biogen, Cambridge, MA, USA. Electronic address: bing.zhu@biogen.com.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Ih', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Deykin', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Sarah I', 'Initials': 'SI', 'LastName': 'Sheikh', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30137-1'] 936,31281606,"Psychological wellness, yoga and quality of life in patients affected by schizophrenia spectrum disorders: A pilot study.","Schizophrenia is a serious psychiatric disorder characterized by positive symptoms, negative symptoms and neurocognitive deficits. The aim of this study was to estimate relationships between wellness, yoga and quality of life in patients affected by schizophrenia spectrum disorders. Participants were 30 patients with a diagnosis of schizophrenia in care at the Rehabilitative Psychiatry and Research Villa Chiara Clinic in Mascalucia (Catania, Italy), after that randomly assigned to two groups. The first group followed the experimental treatment with sets of yoga exercises conducted by a yoga trainer and a psychiatrist or a clinical psychologist expert in yoga, while a second control group was treated with usual care. The results revealed a significant difference, before and after treatment, between the experimental group and the control group in quality of life.",2019,"The results revealed a significant difference, before and after treatment, between the experimental group and the control group in quality of life.","['patients affected by schizophrenia spectrum disorders', 'Participants were 30 patients with a diagnosis of schizophrenia in care at the Rehabilitative Psychiatry and Research Villa Chiara Clinic in Mascalucia (Catania, Italy']","['yoga exercises conducted by a yoga trainer and a psychiatrist or a clinical psychologist expert in yoga, while a second control group was treated with usual care']","['Psychological wellness, yoga and quality of life', 'wellness, yoga and quality of life', 'quality of life']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist (occupation)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0034380'}]",30.0,0.0450331,"The results revealed a significant difference, before and after treatment, between the experimental group and the control group in quality of life.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': 'CTA-Villa Chiara Psychiatric Rehabilitation Clinic and Research, Mascalucia, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Auditore', 'Affiliation': 'CTA-Villa Chiara Psychiatric Rehabilitation Clinic and Research, Mascalucia, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': 'CTA-Villa Chiara Psychiatric Rehabilitation Clinic and Research, Mascalucia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pipitone', 'Affiliation': 'Vidya Vahini Trust, Uttarkashi, Himalayas, India.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Inguscio', 'Affiliation': 'Department of Psychology, La Sapienza University, Rome, Italy.'}]",Mental illness,['10.4081/mi.2019.8003'] 937,31838589,Personal Approach to Treatment Choices for HIV (PATCH): Randomized Controlled Trial of a Brief Motivational Enhancement Intervention to Improve Medication Adherence in Persons with HIV.,"This pilot randomized controlled trial evaluated the feasibility and efficacy of a brief motivational enhancement intervention to improve adherence to antiretroviral therapy in persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH). We compared PATCH to an active control condition on self-reported adherence, clinical outcomes, and psychosocial outcomes. Participants were 34 individuals (61.8% male, M age  = 47.1) receiving HIV-related services who were suboptimally engaged in care. Participants completed baseline measures, participated in either PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments. Results revealed no differences between conditions on adherence or clinical outcomes. At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months. Results suggest that motivational enhancement interventions can improve psychosocial outcomes for people with HIV. That some improvements were not maintained at follow-up suggests that effects wane over time and longer treatment may be indicated for lasting effects.",2020,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","['people with HIV', 'HIV (PATCH', 'Persons with HIV', 'Participants were 34 individuals (61.8% male, M age \u2009=\u200947.1) receiving HIV-related services who were suboptimally engaged in care', 'persons with HIV called Personal Approach to Treatment Choices for HIV (PATCH']","['motivational enhancement intervention', 'Motivational Enhancement Intervention', 'motivational enhancement interventions', 'PATCH or a stress reduction skills control intervention, and completed post-treatment and 3-month follow-up assessments']","['psychosocial outcomes', 'Medication Adherence', 'alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",34.0,0.0572077,"At post-treatment, PATCH participants reported greater improvements in alcohol use, psychiatric symptoms, subjective mental functioning, and emotion-focused coping; improvements in subjective mental functioning were maintained at 3-months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Scharer', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': 'Minds in Focus Psychological Services, Baltimore, MD, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Medoff', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Himelhoch', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, Lexington, KY, USA.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA. mbennett@som.umaryland.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02759-3'] 938,31282193,Effect of a mindfulness programme training to prevent the sport injury and improve the performance of semi-professional soccer players.,"OBJECTIVE Mindfulness improves psychological outcomes. We examined whether greater mindfulness scores were associated with reduced injury rates in soccer players, as well as improved performance at both the individual and team level. METHOD This was a parallel-group, pre- and post-test, randomised controlled pilot trial. Forty-five male amateur soccer players from Tehran, Iran, were randomly assigned into experimental (n=23) and control groups (n=22). Outcomes were scores on the mindfulness sport inventory, as well as injury rates and recovery as assessed by a physiotherapist using standardised criteria. Expert observers assessed the effect on individual and team performance. Data were analysed using mixed analysis of variance and, where indicated, its non-parametric alternative, the Friedman test. RESULTS Significantly greater mindfulness scores in the intervention group were associated with both reduced injury and improved performance. CONCLUSION Mindfulness training shows promise in preventing injury and improving performance. The intervention could be applied to other sports and be helpful in clinical settings given the importance of exercise in promoting psychological well-being.",2019,"Significantly greater mindfulness scores in the intervention group were associated with both reduced injury and improved performance. ","['semi-professional soccer players', 'Forty-five male amateur soccer players from Tehran, Iran']","['Mindfulness training', 'mindfulness programme training']","['mindfulness scores', 'reduced injury and improved performance', 'psychological outcomes', 'mindfulness sport inventory, as well as injury rates and recovery']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",45.0,0.122147,"Significantly greater mindfulness scores in the intervention group were associated with both reduced injury and improved performance. ","[{'ForeName': 'Majid Mozafari', 'Initials': 'MM', 'LastName': 'Zadeh', 'Affiliation': ""Motor Behavior and Sport Psychology Department, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Ajilchi', 'Affiliation': ""Motor Behavior and Sport Psychology Department, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Salman', 'Affiliation': ""Motor Behavior and Sport Psychology Department, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kisely', 'Affiliation': 'Princess Alexandra Hospital Southside Clinical Unit, Faculty of Medicine, The University of Queensland, Woolloongabba, QLD, Australia.'}]",Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists,['10.1177/1039856219859288'] 939,31125055,"A Phase 2 Study Evaluating the Safety, Tolerability, and Immunogenicity of Two 3-Dose Regimens of a Clostridium difficile Vaccine in Healthy US Adults Aged 65 to 85 Years.","BACKGROUND Clostridium difficile causes toxin-mediated nosocomial diarrhea and community-acquired infections; no preventive vaccine is licensed. In this phase 2 study, we explored safety, tolerability, and immunogenicity in older US adults of an investigational bivalent C. difficile vaccine that contains equal dosages of genetically and chemically detoxified toxins A and B. METHODS Conducted from July 2015 through March 2017, 855 healthy adults aged 65-85 years from 15 US centers were randomized 3:3:1 to receive vaccine (100 or 200 μg) or placebo at 0, 1, and 6 months (month regimen) or 1, 8, and 30 days (day regimen). Serum toxin A- and B-specific neutralizing antibodies were measured. Participant-reported local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs were recorded. RESULTS The 200-μg dose level elicited higher immune responses than the 100-µg dose level across regimens. Compared with the day regimen, the month regimen induced stronger and more persistent immune responses that remained elevated 12 months after dose 3. Responses peaked at month 7 (month regimen) and day 37 (day regimen). LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups. More related AEs were reported in the day regimen group than the month regimen group. CONCLUSIONS The C. difficile vaccine was safe, well tolerated, and immunogenic in healthy US adults aged 65-85 years. Immune responses were particularly robust in the 200-μg month regimen group. These results support continued vaccine development. CLINICAL TRIALS REGISTRATION NCT02561195.",2020,LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups.,"['healthy US adults aged 65-85 years', 'Conducted from July 2015 through March 2017, 855 healthy adults aged 65-85 years from 15 US centers', 'older US adults', 'Aged 65 to 85 Years', 'Healthy US Adults']","['placebo', 'vaccine', 'Clostridium difficile Vaccine']","['Immune responses', 'Safety, Tolerability, and Immunogenicity', 'persistent immune responses', 'LRs (primarily injection site pain', 'Serum toxin A- and B-specific neutralizing antibodies', 'safe, well tolerated, and immunogenic', 'local reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chronic medical conditions, and immediate AEs', 'safety, tolerability, and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0076851', 'cui_str': 'toxin A (Pseudomonas)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",855.0,0.214698,LRs (primarily injection site pain) were more frequent in vaccine recipients than controls; SE frequency was similar across groups.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Pfizer Vaccine Clinical Research & Development, Hurley, United Kingdom.'}, {'ForeName': 'Shon A', 'Initials': 'SA', 'LastName': 'Remich', 'Affiliation': 'Pfizer Vaccine Research & Development, Collegeville, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'Foothill Family Clinic, Salt Lake City, Utah.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Pfizer Vaccine Research & Development, Collegeville, Pennsylvania.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Pride', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Annaliesa S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Knirsch', 'Affiliation': 'Pfizer Vaccine Research & Development, Pearl River, New York.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research & Development, Hurley, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz153'] 940,31278067,"Safety and efficacy of epigallocatechin gallate in multiple system atrophy (PROMESA): a randomised, double-blind, placebo-controlled trial.","BACKGROUND Multiple system atrophy is a rare neurodegenerative disease characterised by aggregation of α-synuclein in oligodendrocytes and neurons. The polyphenol epigallocatechin gallate inhibits α-synuclein aggregation and reduces associated toxicity. We aimed to establish if epigallocatechin gallate could safely slow disease progression in patients with multiple system atrophy. METHODS We did a randomised, double-blind, parallel group, placebo-controlled clinical trial at 12 specialist centres in Germany. Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month. Participants were randomly assigned (1:1) to epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2) that was stratified by disease subtype (parkinsonism-predominant disease vs cerebellar-ataxia-predominant disease). All participants and study personnel were masked to treatment assignment. Participants were given one hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol) orally once daily for 4 weeks, then one capsule twice daily for 4 weeks, and then one capsule three times daily for 40 weeks. After 48 weeks, all patients underwent a 4-week wash-out period. The primary endpoint was change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 52 weeks. Efficacy analyses were done in all people who received at least one dose of study medication. Safety was analysed in all people who received at least one dose of the study medication to which they had been randomly assigned. This trial is registered with ClinicalTrials.gov (NCT02008721) and EudraCT (2012-000928-18), and is completed. FINDINGS Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to placebo. Of these, 67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation). There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51). Four patients in the epigallocatechin gallate group and two in the placebo group died. Two patients in the epigallocatechin gallate group had to stop treatment because of hepatotoxicity. INTERPRETATION 48 weeks of epigallocatechin gallate treatment did not modify disease progression in patients with multiple system atrophy. Epigallocatechin gallate was overall well tolerated but was associated with hepatotoxic effects in some patients, and thus doses of more than 1200 mg should not be used. FUNDING ParkinsonFonds Deutschland, German Parkinson Society, German Neurology Foundation, Lüneburg Foundation, Bischof Dr Karl Golser Foundation, and Dr Arthur Arnstein Foundation.",2019,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"['12 specialist centres in Germany', 'patients with multiple system atrophy', '67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation', 'multiple system atrophy (PROMESA', 'Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to', ""Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month"", 'all people who received at least one dose of the study medication to which they had been randomly assigned']","['placebo', 'EudraCT', 'hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol', 'epigallocatechin gallate', 'epigallocatechin gallate treatment', 'epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2']","['hepatotoxicity', 'toxicity', 'Safety and efficacy', 'hepatotoxic effects', 'change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS', 'Safety']","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0222045'}]",127.0,0.6823,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany; German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Maaß', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Schuberth', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Giese', 'Affiliation': 'Center for Neuropathology and Prion Research, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Oertel', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trenkwalder', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Südmeyer', 'Affiliation': 'Institute of Clinical Neuroscience and Medical Psychology, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Eggert', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Mollenhauer', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurology, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Löhle', 'Affiliation': 'Department of Neurology, University of Rostock, Rostock, Germany; German Center for Neurodegenerative Diseases, Rostock, Germany; Department of Neurology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Classen', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Münchau', 'Affiliation': 'Institute of Neurogenetics, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kassubek', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Gandor', 'Affiliation': 'Movement Disorders Hospital, Beelitz-Heilstätten, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany; Department of Neurology, Christian-Albrechts-University Kiel, Kiel, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Egert-Schwender', 'Affiliation': 'Münchner Studienzentrum, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Eberhardt', 'Affiliation': 'Pharmacy Department, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Max Delbrueck Center for Molecular Medicine, NeuroCure Experimental and Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Bötzel', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Ertl-Wagner', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany; Department of Radiology, The Hopsital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Huppertz', 'Affiliation': 'Swiss Epilepsy Clinic, Klinik Lengg, Zurich, Switzerland.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Günter U', 'Initials': 'GU', 'LastName': 'Höglinger', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany; Department of Neurology, Hanover Medical School, Hanover, Germany. Electronic address: guenter.hoeglinger@dzne.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30141-3'] 941,31278429,Comparison of efficacy and safety of a novel 755-nm diode laser with conventional 755-nm alexandrite laser in reduction of axillary hairs.,"The aim of this study was to compare the efficacy and safety of a novel diode system emitting 755 nm wavelength with conventional 755 nm alexandrite laser in skin types III and IV. It was a randomized, right-left comparison, assessor-blind, clinical study. Sixteen female volunteers age 29.52 ± 9.52 were randomly assigned to receive six treatment sessions using 755 nm diode laser on one axilla and 755 nm alexandrite on the opposite axilla. Efficacy was assessed by counting of hairs per square centimeter, 6 months after the last treatment. Treatment outcome was also evaluated by blind reviewing of before and after pictures, using Physician Global Assessment scale (GAS). Subject satisfaction was assessed using visual analogue scale (VAS), pain level and adverse effects were recorded. Skin biophysical parameters (transepidermal water loss, skin sebum, and erythema index) were also measured. Significant reduction in hair count was observed, 6 months after the last treatment session, for both devices (- 33% for 755 nm diode and - 35% for 755 nm alexandrite; p value = 0.85). The mean GAS score was 2.66 for alexandrite treated side vs. 2.00 for diode treated side (p value = 0.036). No severe adverse events were reported. The subject satisfaction score was significantly higher after treatment with alexandrite laser. No significant changes were detected in none of skin biophysical parameters. 755 nm diode laser is suitable for hair removal procedures and it is as effective and safe as the 755 nm alexandrite laser in skin types III-IV.",2020,755 nm diode laser is suitable for hair removal procedures and it is as effective and safe as the 755 nm alexandrite laser in skin types III-IV.,['Sixteen female volunteers age 29.52\u2009±\u20099.52'],"['novel 755-nm diode laser with conventional 755-nm alexandrite laser', '755\xa0nm diode laser', 'novel diode system emitting 755\xa0nm wavelength with conventional 755\xa0nm alexandrite laser', 'six treatment sessions using 755\xa0nm diode laser on one axilla and 755']","['Efficacy', 'Physician Global Assessment scale (GAS', 'hair count', 'Skin biophysical parameters (transepidermal water loss, skin sebum, and erythema index', 'visual analogue scale (VAS), pain level and adverse effects', 'severe adverse events', 'mean GAS score', 'subject satisfaction score', 'efficacy and safety', 'skin biophysical parameters']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4517872', 'cui_str': 'Seven hundred and fifty-five'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite Lasers'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",16.0,0.022289,755 nm diode laser is suitable for hair removal procedures and it is as effective and safe as the 755 nm alexandrite laser in skin types III-IV.,"[{'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Ayatollahi', 'Affiliation': 'Center for Research & Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, 415 Taleghani Avenue, Tehran, 1416613675, Iran.'}, {'ForeName': 'Aniseh', 'Initials': 'A', 'LastName': 'Samadi', 'Affiliation': 'Center for Research & Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, 415 Taleghani Avenue, Tehran, 1416613675, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rajabi-Estarabadi', 'Affiliation': 'Dermatology and Cutaneous Surgery, University of Miami School of Medicine, 1475 NW 12th Ave., Miami, FL, 33136, USA.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Yadangi', 'Affiliation': 'Center for Research & Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, 415 Taleghani Avenue, Tehran, 1416613675, Iran.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Nouri', 'Affiliation': 'Dermatology and Cutaneous Surgery, University of Miami School of Medicine, 1475 NW 12th Ave., Miami, FL, 33136, USA.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Firooz', 'Affiliation': 'Center for Research & Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, 415 Taleghani Avenue, Tehran, 1416613675, Iran. firozali@sina.tums.ac.ir.'}]",Lasers in medical science,['10.1007/s10103-019-02829-x'] 942,30809633,"A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial.","BACKGROUND The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. METHODS We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. RESULTS We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0-8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0- 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of -5.5 (95% confidence interval -13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. CONCLUSIONS The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. CLINICAL TRIALS REGISTRATION NCT02114684.",2020,"There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks [83.0% (Moxifloxacin) vs 78.5% (Control), p=0.463], however the median time to culture conversion was significantly shorter (6.0 weeks, IQR 4.0 - 8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0- 11.4) (p=0.018).","['recurrent drug-sensitive pulmonary tuberculosis', 'We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with HIV', 'recurrent TB']","['Moxifloxacin', 'moxifloxacin', 'moxifloxacin-based regimen', 'moxifloxacin-containing treatment regimen']","['proportion of patients achieving culture conversion', 'serious adverse events', 'sputum culture conversion rate', 'adverse events', 'culture conversion rates', 'median time to culture conversion']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",196.0,0.173338,"There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks [83.0% (Moxifloxacin) vs 78.5% (Control), p=0.463], however the median time to culture conversion was significantly shorter (6.0 weeks, IQR 4.0 - 8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0- 11.4) (p=0.018).","[{'ForeName': 'Rubeshan', 'Initials': 'R', 'LastName': 'Perumal', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}, {'ForeName': 'Nesri', 'Initials': 'N', 'LastName': 'Padayatchi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}, {'ForeName': 'Dhineshree', 'Initials': 'D', 'LastName': 'Govender', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Congella.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz152'] 943,31744319,Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans.,"BACKGROUND Lasmiditan demonstrated superiority to placebo in the acute treatment of migraine in adults with moderate/severe migraine disability in two similarly designed Phase 3 trials, SAMURAI and SPARTAN. Post-hoc integrated analyses evaluated the efficacy of lasmiditan in patients who reported a good or insufficient response to triptans and in those who were triptan naïve. METHODS Subgroups of patients reporting an overall response of ""good"" or ""poor/none"" to the most recent use of a triptan at baseline (defined as good or insufficient responders, respectively) and a triptan-naïve subpopulation were derived from combined study participants randomized to receive lasmiditan 50 mg (SPARTAN only), 100 mg or 200 mg, or placebo, as the first dose. Outcomes including headache pain-freedom, most bothersome symptom-freedom, and headache pain relief 2 hours post-first dose of lasmiditan were compared with placebo. Treatment-by-subgroup analyses additionally investigated whether therapeutic benefit varied according to prior triptan response (good or insufficient). RESULTS Regardless of triptan response, lasmiditan showed higher efficacy than placebo (most comparisons were statistically significant). Treatment-by-subgroup analyses found that the benefit over placebo of lasmiditan did not vary significantly between patients with a good response and those with an insufficient response to triptans. Lasmiditan also showed higher efficacy than placebo in triptan-naïve patients. CONCLUSIONS Lasmiditan demonstrated comparable efficacy in patients who reported a good or insufficient response to prior triptan use. Lasmiditan also showed efficacy in those who were triptan naïve. Lasmiditan may be a useful therapeutic option for patients with migraine. TRIAL REGISTRATION SAMURAI (NCT02439320); SPARTAN (NCT02605174).",2020,Treatment-by-subgroup analyses found that the benefit over placebo of lasmiditan did not vary significantly between patients with a good response and those with an insufficient response to triptans.,"['patients with migraine', 'adults with moderate/severe migraine disability', 'patients who reported a good or insufficient response to triptans and in those who were triptan naïve', 'Subgroups of patients reporting an overall response of ""good"" or ""poor/none"" to the most recent use of a triptan at baseline (defined as good or insufficient responders, respectively) and a triptan-naïve subpopulation']","['placebo', 'lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg or 200\u2009mg, or placebo']","['headache pain-freedom, most bothersome symptom-freedom, and headache pain relief 2 hours post-first dose of lasmiditan']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C1567966', 'cui_str': 'Triptans'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.0570906,Treatment-by-subgroup analyses found that the benefit over placebo of lasmiditan did not vary significantly between patients with a good response and those with an insufficient response to triptans.,"[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Knievel', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Buchanan', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lombard', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Baygani', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Raskin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Li Shen', 'Initials': 'LS', 'LastName': 'Loo', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Tobin', 'Affiliation': '21st Century Neurology, Xenoscience, Phoenix, AZ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419889350'] 944,31276178,Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.,"Importance Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03). Conclusions and Relevance Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration ClinicalTrials.gov identifier: NCT00697047.",2019,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","['59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity', 'March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington', '838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled', '838 participants (mean [SD] age']","['colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n\u2009=\u2009270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n\u2009=\u2009284; mailings plus a 1 in 10 chance of receiving $50 on screening completion']","['completion of any colorectal cancer screening', 'Colorectal Cancer Screening Uptake and Decrease Disparities', 'FIT completion', 'Completion of any colorectal screening', 'FIT or colonoscopy completion']","[{'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517801', 'cui_str': '52.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0282599', 'cui_str': 'Integrated Health Care Systems'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",838.0,0.172407,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","[{'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chubak', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fuller', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Kilian J', 'Initials': 'KJ', 'LastName': 'Kimbel', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Kullgren', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotion and Behavior Sciences, University of Texas School of Public Health, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.6570'] 945,31273569,Efficacy and safety of diode laser during circumvestibular incision for Le Fort I osteotomy in orthognathic surgery: a triple-blind randomized clinical trial.,"The aim of this triple-blind randomized clinical trial was to evaluate the efficacy and safety of diode laser during circumvestibular incisions for Le Fort I osteotomy in orthognathic surgeries in comparison with conventional techniques using electrocautery and scalpel. Patients were randomly allocated to one of three groups based on the technique employed to perform incisions: diode laser, electrocautery, and scalpel. The parameters used to evaluate the efficacy and safety of diode laser were incision velocity, duration of surgery, bleeding rate, alterations in postoperative functions, pain, edema, wound clinical healing, and infection. Thirty patients were enrolled in the study (10 per group). Regarding bleeding, the incisions performed with diode laser promoted a lower bleeding rate compared with scalpel and electrocautery (p = 0.00). The diode surgical laser was effective during the incision procedure, but required a longer time to perform the incisions compared with the other techniques evaluated (p < 0.05). No statistically significant difference was detected between groups regarding total surgical time or other safety parameters (p > 0.05). Thus, diode laser proved to be effective and safer during circumvestibular incisions for Le Fort I osteotomy than conventional devices.",2020,No statistically significant difference was detected between groups regarding total surgical time or other safety parameters (p > 0.05).,"['orthognathic surgery', 'Thirty patients were enrolled in the study (10 per group']","['diode laser during circumvestibular incision', 'technique employed to perform incisions: diode laser, electrocautery, and scalpel', 'diode laser', 'electrocautery and scalpel', 'diode laser during circumvestibular incisions for Le Fort I osteotomy', 'diode surgical laser']","['efficacy and safety of diode laser were incision velocity, duration of surgery, bleeding rate, alterations in postoperative functions, pain, edema, wound clinical healing, and infection', 'total surgical time or other safety parameters', 'Efficacy and safety', 'efficacy and safety', 'bleeding rate']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0407442', 'cui_str': 'Le Fort I osteotomy (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0392674,No statistically significant difference was detected between groups regarding total surgical time or other safety parameters (p > 0.05).,"[{'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Jaeger', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Gustavo Marques de Oliveira', 'Initials': 'GMO', 'LastName': 'Chiavaioli', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, Hospital da Baleia - CENTRARE, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Guilherme Lacerda', 'Initials': 'GL', 'LastName': 'de Toledo', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, Hospital da Baleia - CENTRARE, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Belini', 'Initials': 'B', 'LastName': 'Freire-Maia', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, Hospital da Baleia - CENTRARE, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Marcio Bruno Figueiredo', 'Initials': 'MBF', 'LastName': 'Amaral', 'Affiliation': 'Service of Oral and Maxillofacial Surgery, Hospital da Baleia - CENTRARE, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Mauro Henrique Nogueira Guimarães', 'Initials': 'MHNG', 'LastName': 'de Abreu', 'Affiliation': 'Department of Social and Preventive Dentistry, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'José Alcides Almeida', 'Initials': 'JAA', 'LastName': 'de Arruda', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. alcides_almeida@hotmail.com.'}, {'ForeName': 'Ricardo Alves', 'Initials': 'RA', 'LastName': 'Mesquita', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}]",Lasers in medical science,['10.1007/s10103-019-02832-2'] 946,31227804,Fatty acid regio-specificity of triacylglycerol molecules may affect plasma lipid responses to dietary fats-a randomised controlled cross-over trial.,"BACKGROUND/OBJECTIVES Hypercholesterolaemic effects of saturated fatty acids (SFA) may be influenced not only by the chain length, but also by their specific location within the triacylglycerol (TAG) molecule. We examined the hypothesis that dietary fats rich in SFA, but containing mostly unsaturated fatty acids in the sn-2 position with most SFA in sn-1 and -3 (palm olein [PO] and cocoa butter [CB]) will have similar serum lipid outcomes to unsaturated olive oil (OO). SUBJECTS/METHODS Thirty-eight participants (20-40 yr, 18.5- ≤ 27.5 kg/m 2 ) completed a 4-week randomised 3 × 3 crossover feeding intervention, preceded by 2-week run-in and separated by 2-week washout periods. Background diet contained 35 percentage of total energy (%E) fat, 18%E protein, 48%E carbohydrates, differing in test fats only (palm olein (PO), CB, OO; 20%E). Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions, were assessed pre- and post-intervention. Data were analysed using mixed effects longitudinal models with a P-value < 0.05 considered significant. RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB. No differences were seen for TC/HDL-C (mean [95%CI] change for PO, 0.08[0.00, 0.15] mmol/L; CB, 0.06 [-0.05, 0.16] mmol/L; and OO, -0.01 [-0.15, 0.13] mmol/L; P = 0.53] or any other parameter including LDL sub-fractions. OO decreased IDL-A compared to PO (-2.2 [-4.31, -0.21] mg/dL, P = 0.03). CONCLUSION In healthy young participants, plasma lipid responses to PO and CB, enriched in SFA but having primarily unsaturated fatty acid in the sn-2 position of TAG, did not differ from OO.",2020,"RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","['Thirty-eight participants (20-40\u2009yr, 18.5-\u2009≤\u200927.5', 'healthy young participants']",['saturated fatty acids (SFA'],"['plasma fatty acids', 'plasma lipid responses', 'TC/HDL-C', 'OO and C18:0', 'Total cholesterol (TC)/high density lipoprotein cholesterol (HDL-C) ratio and related variables; TC, HDL-C, low density lipoprotein cholesterol (LDL-C), TAG, apoA1, ApoB, ApoA1 (apolipoprotein A1)/ApoB (apolipoprotein B), lipoprotein (a) (Lp(a)), NEFA, LDL sub-fractions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",38.0,0.0699815,"RESULTS Changes in plasma fatty acids (P < 0.05) confirmed compliance; C18:1 increased with OO compared to PO and CB; C16:0 decreased with OO and C18:0 increased following CB.","[{'ForeName': 'Welma', 'Initials': 'W', 'LastName': 'Stonehouse', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia. welma.stonehouse@csiro.au.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Benassi-Evans', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'James-Martin', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mahinda', 'Initials': 'M', 'LastName': 'Abeywardena', 'Affiliation': 'Commonwealth Scientific Industrial Research Organisation, Health and Biosecurity, Adelaide, South Australia, Australia.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0452-7'] 947,31167870,"Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study.","INTRODUCTION Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. METHODS AND ANALYSIS A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan. ETHICS AND DISSEMINATION The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.",2019,"The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. ","['patients with RA and AS with low disease activity', 'RA and AS patients treated in routine care', 'patients with rheumatoid arthritis or ankylosing spondylitis']","['cannabidiol (CBD', 'medical cannabis', 'placebo', 'cannabidiol followed by an open label', 'tetrahydrocannabinol', 'tetrahydrocannabinol (THC']","['Pain and fatigue', 'Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0813973', 'cui_str': 'Medicinal Cannabis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0709882,"The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity. ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hendricks', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Tonny Elmose', 'Initials': 'TE', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychology, Syddansk Universitet Det Sundhedsvidenskabelige Fakultet, Odense, Denmark.'}, {'ForeName': 'Afshin Ashouri', 'Initials': 'AA', 'LastName': 'Christiansen', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Primdahl', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Hauge', 'Affiliation': 'Department of Rheumatology, Aarhus Universitet Health, Aarhus, Denmark.'}, {'ForeName': 'Torkell', 'Initials': 'T', 'LastName': 'Ellingsen', 'Affiliation': 'Rheumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tina Ingrid', 'Initials': 'TI', 'LastName': 'Horsted', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Anja Godske', 'Initials': 'AG', 'LastName': 'Bachmann', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Anne Gitte', 'Initials': 'AG', 'LastName': 'Loft', 'Affiliation': 'Department of Rheumatology, Aarhus Universitet Health, Aarhus, Denmark.'}, {'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Department of Rheumatology, COPECARE, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Lund Hetland', 'Affiliation': 'Department of Rheumatology, COPECARE, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Niels Steen', 'Initials': 'NS', 'LastName': 'Krogh', 'Affiliation': 'Department of Rheumatology, COPECARE, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kirsten Kaya', 'Initials': 'KK', 'LastName': 'Roessler', 'Affiliation': 'Department of Psychology, Syddansk Universitet Det Sundhedsvidenskabelige Fakultet, Odense, Denmark.'}, {'ForeName': 'Kim Hørslev', 'Initials': 'KH', 'LastName': 'Petersen', 'Affiliation': 'Rheumatology, Danish Hospital for Rheumatic Diseases, Gråsten, Denmark.'}]",BMJ open,['10.1136/bmjopen-2018-028197'] 948,31027892,"An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients.","This is a randomized trial (ATHENA study) in de novo kidney transplant patients to compare everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. In this 12-month, multicenter, open-label study, de novo kidney transplant recipients were randomized to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. Non-inferiority of the primary end point (estimated glomerular filtration rate [eGFR] at month 12), assessed in the per-protocol population of 338 patients, was not shown for EVR/TAC or EVR/CsA versus MPA/TAC. In 123 patients with TAC levels within the protocol-specified range, eGFR outcomes were comparable between groups. The mean increase in eGFR during months 1 to 12 post-transplant, analyzed post hoc, was similar with EVR/TAC or EVR/CsA versus MPA/TAC. The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC. Most biopsy-proven acute rejection events in this study were graded mild (BANFF IA). There were no differences in proteinuria between groups. Cytomegalovirus and BK virus infection were significantly more frequent with MPA/TAC. Thus, everolimus with TAC or CsA showed comparable efficacy to MPA/TAC in de novo kidney transplant patients. Non-inferiority of renal function, when pre-specified, was not shown, but the mean increase in eGFR from month 1 to 12 was comparable to MPA/TAC.",2019,"The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC.","['de novo kidney transplant patients', 'novo kidney transplant recipients', '123 patients with TAC levels', 'de\xa0novo kidney transplant patients']","['MPA/TAC', 'everolimus with tacrolimus or cyclosporine', 'everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC', 'everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure', 'everolimus with concomitant tacrolimus or cyclosporine (CsA']","['glomerular filtration rate [eGFR', 'mean increase in eGFR', 'proteinuria', 'incidence of treatment failure (biopsy proven acute rejection, graft loss or death', 'eGFR', 'Cytomegalovirus and BK virus infection', 'renal function']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0162643'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1096691', 'cui_str': 'BK virus infection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",123.0,0.0269397,"The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Nephrology Unit, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Suwelack', 'Affiliation': 'Department of Internal Medicine D, Transplant Nephrology, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Duska', 'Initials': 'D', 'LastName': 'Dragun', 'Affiliation': 'Department of Nephrology and Intensive Care Medicine, Charité Universtätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schenker', 'Affiliation': 'Department of Surgery, University Hospital Knappschaftskrankenhaus Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Hauser', 'Affiliation': 'Department of Nephrology, Goethe University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Duisburg-Essen, Essen, Germany; Department of Nephrology, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hugo', 'Affiliation': 'University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology-Transplantation-Dialysis-Apheresis, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Junge', 'Affiliation': 'Novartis Pharma GmbH, Nuernberg, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Thaiss', 'Affiliation': 'III. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nashan', 'Affiliation': 'Department of Hepatobiliary Surgery and Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: bjoern.nashan@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.01.041'] 949,31261260,Perineal Pressure During Hip Arthroscopy Is Reduced by Use of Trendelenburg: A Prospective Study With Randomized Order of Positioning.,"BACKGROUND The use of traction during hip arthroscopy is commonly used to provide safe joint access and to improve visualization. However, traction during hip arthroscopy has been associated with complications ranging from transient neuropraxias to devastating soft-tissue necrosis. Trendelenburg positioning may be helpful, but the degree to which this is true is not well understood. QUESTIONS/PURPOSES To determine whether there would be a reduction in perineal pressure at 5°, 10°, and 15° of Trendelenburg compared with baseline (0° of Trendelenburg) while in the modified supine position during hip arthroscopy. METHODS A consecutive cohort of 50 patients treated with hip arthroscopy by a single, high-volume orthopaedic surgeon was analyzed. There were 30 females and 20 males in this study, with a mean age of 36 ± 16 years (range, 14 to 66 years); mean BMI was 26 kg/m. In the operating room, patients were placed in the modified supine position on a traction extension table with a well-padded perineal post. A standard blood pressure cuff was secured to the post to measure pressure exerted on the perineum as traction was applied to distract the hip. For each patient, pressure against the perineum was measured at four different positions using a digital level: 0°, 5°, 10°, and 15° of Trendelenburg. These positions were tested in a random order for each patient. Mean pressure was compared within patients under the four-period crossover design using a repeated-measure (mixed) ANOVA model. Examination of the residual error quantile plot showed that the pressure data followed a normal distribution, making the use of a parametric model appropriate. Tests were made for period and order effects. RESULTS Compared with baseline (0° or no Trendelenburg) there was a reduction in pressure of 4.4 (15.5%) at 5° of Trendelenburg (p = 0.203), 8 (28%) at 10° of Trendelenburg (p = 0.022) and 13.1 (46%) at 15° (p = 0.006). These results were maintained regardless of the sequence of positions used in each patient (0°, 5°, 10°, 15°). CONCLUSIONS Trendelenburg positioning of 10° and 15° during hip arthroscopy resulted in decreased perineal pressure compared with the neutral (0°) position. This technique is intended to harness gravity to exert the majority of countertraction while retaining the perineal post as a backup patient stabilizer. Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure. Future studies should assess whether the observed differences in perineal pressure will reduce the frequency of post-related complications after hip arthroscopy. LEVEL OF EVIDENCE Level II, therapeutic study.",2019,"Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure.","['A consecutive cohort of 50 patients treated with hip arthroscopy by a single, high-volume orthopaedic surgeon was analyzed', '30 females and 20 males in this study, with a mean age of 36 ± 16 years (range, 14 to 66 years); mean BMI was 26 kg/m']","['Hip Arthroscopy', 'Trendelenburg']","['Mean pressure', 'Perineal Pressure', 'perineal pressure', 'reduction in pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0334891', 'cui_str': 'Orthopedists'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]","[{'cui': 'C0445074', 'cui_str': 'Mean pressure (qualifier value)'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0289102,"Routine introduction of Trendelenburg during hip arthroscopy reduces perineal pressure against the post, which may decrease complications related to traction and perineal pressure.","[{'ForeName': 'Ajay C', 'Initials': 'AC', 'LastName': 'Lall', 'Affiliation': 'A. C. Lall, M. R. Battaglia, D. R. Maldonado, B. G. Domb, American Hip Institute, Des Plaines, IL, USA A. A. Saadat, Department of Orthopedics, University of Illinois at Chicago, Chicago, IL, USA M. R. Battaglia, University of Chicago Pritzker School of Medicine, Chicago, IL, USA I. Perets, Department of Orthopedics, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Ardavan A', 'Initials': 'AA', 'LastName': 'Saadat', 'Affiliation': ''}, {'ForeName': 'Muriel R', 'Initials': 'MR', 'LastName': 'Battaglia', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Maldonado', 'Affiliation': ''}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Perets', 'Affiliation': ''}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Domb', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000804'] 950,31800496,Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial.,"OBJECTIVE The aim of this study was to evaluate the safety and feasibility of nonoperative treatment of acute nonperforated appendicitis in children during 5 years of follow-up. METHODS A 4-year follow-up of a previous randomized controlled pilot trial, including 50 children with acute nonperforated appendicitis, was performed. The patients were initially randomized to nonoperative treatment with antibiotics or appendectomy with 1-year follow-up previously reported. Data were extracted from the computerized notes and telephone interviews.The primary outcome was treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis. RESULTS The children were followed up for at least 5 years [median 5.3 (range 5.0-5.6)] after inclusion. There were no failures in the appendectomy group (0/26) and 11 failures in the nonoperative group (11/24). Nine failures had occurred during the first year after inclusion, 2 of whom had histologically confirmed appendicitis. There were 2 further patients with recurrent acute appendicitis 1 to 5 years after inclusion. Both these patients had uncomplicated laparoscopic appendectomies for histologically confirmed acute appendicitis. There were no losses to follow-up. CONCLUSIONS At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%). Treatment with antibiotics seems to be safe in the intermediate-term; none of the children previously treated nonoperatively re-presented with complicated appendicitis.",2020,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","['Acute Nonperforated Appendicitis in Children', '50 children with acute nonperforated appendicitis, was performed', 'acute nonperforated appendicitis in children during 5 years of follow-up']","['antibiotics', 'antibiotics or appendectomy', 'nonoperative treatment', 'Nonoperative Treatment Versus Appendectomy']","['recurrent acute appendicitis', 'safety and feasibility', 'acute appendicitis', 'treatment failure, defined as need for a secondary intervention under general anesthesia, related to the previous diagnosis of acute nonperforated appendicitis']","[{'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439589', 'cui_str': 'Recurrent acute (qualifier value)'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0162643'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis (contextual qualifier) (qualifier value)'}]",50.0,0.117108,"At 5 years of follow-up 46% of children treated with antibiotics for acute nonperforated appendicitis had undergone an appendectomy, although acute appendicitis was only histologically confirmed in 4/24 (17%).","[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Patkova', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Almström', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'Surgery Unit, UCL Institute of Child Health, London, United Kingdom, Department of Pediatric Surgery, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Wester', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Svensson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",Annals of surgery,['10.1097/SLA.0000000000003646'] 951,11872775,Crash.,,2002,,[],[],[],[],[],[],,0.0170186,,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 952,31779699,Chimney Trial: study protocol for a randomized controlled trial.,"BACKGROUND Parastomal hernias (PSHs) are common, troubling the lives of people with permanent colostomy. In previous studies, retromuscular keyhole mesh placement has been the most-used technique for PSH prevention but results have been controversial. Additionally, surgical treatment of PSHs is associated with a high rate of complications and recurrences. Therefore, it is crucial to find the most effective way to prevent PSHs in the first place without an increased risk of complications. Due to a lack of adequate research, there is no clear evidence or recommendations on which mesh or technique is best to prevent PSHs. METHODS/DESIGN The Chimney Trial is a Nordic, prospective, randomized controlled, multicenter trial designed to compare the feasibility and the potential benefits of specifically designed, intra-abdominal onlay mesh (DynaMesh®-Parastomal, FEG Textiltechnik GmbH, Aachen, Germany) against controls with permanent colostomy without mesh. The primary outcome of the Chimney Trial is the incidence of a PSH detected by a computerized tomography (CT) scan at 12-month follow-up. Secondary outcomes are the rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs. For each group, 102 patients were enrolled at attending hospitals and randomized at a ratio of 1:1 by browser-based software to receive a preventive mesh or a conventional colostomy without a mesh. Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. DISCUSSION The Chimney Trial aims to provide level-I evidence on PSH prevention. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03799939. Registered on 10 January 2019.",2019,"Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. ","['102 patients were enrolled at attending hospitals', 'controls with permanent colostomy without mesh', 'people with permanent colostomy']",['preventive mesh or a conventional colostomy without a mesh'],"['rate of clinically detected PSHs, surgical-site infection as defined by the Centers for Disease Control and Prevention (CDC), complications as defined by the Clavien-Dindo classification, the reoperation rate, operative time, length of stay, quality of life as measured by the RAND-36 survey and colostomy impact score, and both direct and indirect costs', 'incidence of a PSH detected by a computerized tomography (CT) scan']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0192973', 'cui_str': 'Permanent colostomy (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}]","[{'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0441633'}]",102.0,0.19513,"Patients will be followed for 1 month and at 1, 3, and 5 years after the operation for long-term results and complications. ","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Mäkäräinen-Uhlbäck', 'Affiliation': 'Oulu University Hospital, PL 21, 90029, OYS, Finland. elisa.makarainen-uhlback@ppshp.fi.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Wiik', 'Affiliation': 'Oulu University Hospital, PL 21, 90029, OYS, Finland.'}, {'ForeName': 'Jyrki', 'Initials': 'J', 'LastName': 'Kössi', 'Affiliation': 'Päijät-Häme Central Hospital, Keskussairaalankatu 7, 15850, Lahti, Finland.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Nikberg', 'Affiliation': 'Västmanlands Hospital Västerås, 721 89, Västerås, Sweden.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Oulu University Hospital, PL 21, 90029, OYS, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Oulu University Hospital, PL 21, 90029, OYS, Finland.'}]",Trials,['10.1186/s13063-019-3764-y'] 953,31796488,Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors.,"INTRODUCTION Many successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated. METHODS AND ANALYSIS A two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive-behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group. ETHICS AND DISSEMINATION The Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER NL7573 in the Netherlands Trial Register on 25-02-2019.",2019,"The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs.","['Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs', 'patients with cancer suffer from fear of cancer recurrence (FCR', 'general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR', 'cancer survivors']","['primary care intervention', 'FCR intervention']","['FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs', 'quality of life and their physical, emotional, cognitive and social functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0034380'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",,0.134059,"The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs.","[{'ForeName': 'Yvonne L', 'Initials': 'YL', 'LastName': 'Luigjes-Huizer', 'Affiliation': 'Scientific Research, Helen Dowling Institute, Bilthoven, The Netherlands yluigjes@hdi.nl.'}, {'ForeName': 'Marije L', 'Initials': 'ML', 'LastName': 'van der Lee', 'Affiliation': 'Scientific Research, Helen Dowling Institute, Bilthoven, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Helsper', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-032616'] 954,31494816,Randomized trial of two after-dialysis gabapentin regimens for severe uremic pruritus in hemodialysis patients.,,2019,,['severe uremic pruritus in hemodialysis patients'],['dialysis gabapentin'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}]",[],,0.0237993,,"[{'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Rossi', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Corradini', 'Affiliation': 'Nephrology and Dialysis Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': ""Renal Unit, Nephrology and Dialysis Department, Sant'Andrea Hospital, La Spezia, Italy.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mattei', 'Affiliation': 'Nephrology and Dialysis Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiaccadori', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Vaglio', 'Affiliation': 'Department of Biomedical Clinical and Experimental Sciences ""Mario Serio"", University of Firenze, Florence, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Manenti', 'Affiliation': 'U.O. Nefrologia, Dipartimento di Medicina Generale e Specialistica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci, 14, Parma, 43126, Italy. lmanenti1969@gmail.com.'}]",Internal and emergency medicine,['10.1007/s11739-019-02175-4'] 955,31715440,Long-term naturalistic follow-up of chronic pain in adults with prescription opioid use disorder.,"BACKGROUND Chronic pain is common in patients with prescription opioid use disorder (OUD), and pain severity has been shown to predict opioid use for those with chronic pain. However, recent research suggests that focusing on pain status (i.e., the presence or absence of chronic pain) at treatment initiation may not reflect the clinical significance of pain over the long-term course of OUD. Reports of variability in chronic pain and its clinical significance over time have yet to be investigated in patients with prescription OUD. The present study examined variability in chronic pain status from entry into prescription OUD treatment through 3.5-year follow-up. Additionally, we examined the association between concurrent chronic pain and opioid use at three follow-up time points. METHODS This secondary analysis (N = 309) of a national, randomized, controlled trial of prescription OUD treatment used generalized estimating equations to assess variability in the prevalence of chronic pain from study entry to 3.5-year follow-up, and the association between chronic pain status and concurrent opioid use. RESULTS Fifty-three percent of participants reported variability in chronic pain status over time. The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001). Chronic pain was associated with increased opioid use at each follow-up assessment (aOR = 3.56, p < 0.001). CONCLUSIONS Chronic pain status may vary over time in those with prescription OUD, and chronic pain appears to be associated with concurrent opioid use. The present findings highlight the importance of assessing chronic pain throughout the course of prescription OUD.",2019,"The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001).","['patients with prescription opioid use disorder (OUD', 'adults with prescription opioid use disorder', 'patients with prescription OUD']",['prescription OUD treatment used generalized estimating equations'],"['prevalence of chronic pain', 'Chronic pain', 'chronic pain status', 'chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",309.0,0.0785515,"The prevalence of chronic pain decreased from study entry through follow-up (aOR = 0.47, p < 0.001).","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'McDermott', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychology, Florida State University, Tallahassee, FL 32304, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'Laboratory for Psychiatric Biostatistics, McLean Hospital, Belmont, MA 02478, USA; Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Jamison', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Provost', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA; Department of Psychiatry, Harvard Medical School, Boston, MA 02115, USA. Electronic address: rweiss@mclean.harvard.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107675'] 956,31230925,Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial.,"OBJECTIVES Ultrasound-guided internal jugular vein cannulation is a standard procedure performed in ICUs worldwide. According to the guidelines, the short-axis approach is recommended over the long-axis approach for IJV cannulation. Double-operator cannulation is more convenient for the said procedure. However, the guidelines favor single-operator cannulation due to limited trials. We hypothesized that double-operator long-axis cannulation will be faster and have fewer complications than double-operator short-axis cannulation. METHODS This was a prospective, randomized trial of patients who needed central venous catheterization in the intensive care unit. The eligible patients were randomized into two groups. In one group, the short-axis view by two operators was used for cannulation, and the long-axis view by 2 operators was used in the other group. The time elapsed from skin puncture to guide-wire insertion. RESULTS The central venous catheter was placed by ultrasound guidance in all 100 patients. No significant differences were observed in the patient characteristics between the two groups. The mean time of insertion was 74.2 ± 110.1 s with the short-axis approach compared with 70.3 ± 97.3 s with the long-axis approach. The frequency of complications was also significantly lower with the long-axis approach. DISCUSSION The long-axis view for IJV cannulation has similar insertion and procedure timings to the short-axis view. However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.",2020,"However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.",['patients who needed central venous catheterization in the intensive care unit'],"['Ultrasound-guided internal jugular vein cannulation', 'Short versus long axis ultrasound guided approach for internal jugular vein cannulations', 'double-operator long-axis cannulation', 'Double-operator cannulation']","['frequency of complications', 'mean time of insertion', 'complication rate and number of needle punctures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0007435', 'cui_str': 'Central Catheterization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0522487', 'cui_str': 'Long axis (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",100.0,0.0343039,"However, the complication rate and number of needle punctures required were less with the long-axis view than with those with the short-axis view.","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Rath', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Shakti Bedanta', 'Initials': 'SB', 'LastName': 'Mishra', 'Affiliation': 'Department of Anaesthesiology, IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India. Electronic address: shaktibedantamishra@soauniversity.ac.in.'}, {'ForeName': 'Bhabani', 'Initials': 'B', 'LastName': 'Pati', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Dhar', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Snigdha', 'Initials': 'S', 'LastName': 'Ipsita', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Samal', 'Affiliation': 'IMS and SUM Hospital, Bhubaneswar, Odisha 751014, India.'}, {'ForeName': 'Afzal', 'Initials': 'A', 'LastName': 'Azim', 'Affiliation': 'SGPGI, Lucknow 226014, India.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.06.010'] 957,31122797,Neurodevelopmental effects of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi: a prospective cohort study.,"BACKGROUND Antiretroviral medication during pregnancy and breastfeeding substantially decreases the risk of HIV transmission from mothers to infants, but its effects on the child's neurodevelopment are unknown. This study compared neurodevelopmental outcomes of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children with HIV-unexposed and uninfected children at ages 12, 24, 48, and 60 months. METHODS For this study, a prospective cohort of HIV-exposed and uninfected children was identified from two research sites in the PROMISE-BF trial (at Blantyre, Malawi, and Kampala, Uganda), in which pregnant HIV-infected mothers were randomly assigned to triple antiretroviral prophylaxis (lopinavir-ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir), versus zidovudine alone. Post partum, the mother-infant pairs were randomly assigned to maternal triple antiretroviral treatment or infant nevirapine during breastfeeding. HIV-unexposed and uninfected children matched for age, sex, and socioeconomic background were enrolled at vaccination and well-child clinics at the study sites. We included only children without a history of documented brain infection or injury or substantial malnutrition, and whose mothers were randomly assigned and maintained within their assigned ante-partum and post-partum phases throughout their treatment arm periods. Primary outcomes were the Mullen Scales of Early Learning (MSEL) cognitive composite score at age 12 months, 24 months, and 48 months; and the mental processing index for the Kaufman Assessment Battery for Children, second edition (KABC-II) global score at 48 months and 60 months. Repeated measures were analysed using a linear mixed-effects model controlling for data collection site. FINDINGS Between Aug 23, 2013, and Dec 17, 2014, we co-enrolled 861 children. For MSEL assessments, 738 were eligible for inclusion at age 12 months, 790 at age 24 months, and 692 at age 48 months. For KABC-II assessments, 685 were eligible for inclusion at age 48 months and 445 at age 60 months. There were no differences in MSEL cognitive composite scores according to exposure at age 12 and 24 months (p=0·19 and 0·24, respectively, for comparison of all groups). At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64 [95% CI 77·74-83·54] and 81·34 [78·19-84·48], respectively), compared with those who did remain on triple treatment (adjusted mean 85·93, 95% CI 83·05-88·80; p=0·0486 for the comparison of all groups). The KABC-II composite scores (mental processing index) did not differ at 48 or 60 months according to exposure (p=0·81 and 0·89, respectively, for comparison of all groups). Scores for MSEL and KABC-II for children of mothers on triple antiretrovirals in both the ante-partum and post-partum treatment phases were similar to those for children in the HIV-unexposed and uninfected reference group at all timepoints. INTERPRETATION Maternal triple antiretroviral exposure during both the ante-partum and post-partum phases did not result in greater developmental risks for the mothers' HIV-exposed and uninfected children through age 60 months, compared with children who were HIV-unexposed and uninfected. This might be because ante-partum triple antiretroviral protection of the health of mothers with HIV during pregnancy might be neuroprotective for the child, and when continued post partum, could enhance the quality of caregiving for the child through better clinical care for the mother. FUNDING National Institutes of Health and Eunice Kennedy Shriver National Institute of Child Health and Human Development.",2019,"At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64","['children without a history of documented brain infection or injury or substantial malnutrition, and whose mothers', 'Between Aug 23, 2013, and Dec 17, 2014, we co-enrolled 861 children', 'HIV-unexposed and uninfected children matched for age, sex, and socioeconomic background were enrolled at vaccination and well-child clinics at the study sites', 'HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi', '738 were eligible for inclusion at age 12 months, 790 at age 24 months, and 692 at age 48 months', 'pregnant HIV-infected mothers', '685 were eligible for inclusion at age 48 months and 445 at age 60 months', 'HIV-exposed and uninfected children with HIV-unexposed and uninfected children at ages 12, 24, 48, and 60 months', 'mother-infant pairs']","['maternal triple antiretroviral treatment or infant nevirapine', 'zidovudine alone', 'ante-partum and post-partum antiretroviral exposure', 'triple antiretroviral prophylaxis (lopinavir-ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir']","['KABC-II composite scores (mental processing index', 'mental processing index for the Kaufman Assessment Battery for Children, second edition (KABC-II) global score', 'Mullen Scales of Early Learning (MSEL) cognitive composite score', 'MSEL cognitive composite scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582638', 'cui_str': 'Kaufman assessment battery for children (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",861.0,0.101645,"At 48 months, MSEL cognitive composite scores were worse for children of mothers who did not remain on triple antiretroviral treatment throughout both the ante-partum and post-partum treatment phases (adjusted means 80·64","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Boivin', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA; Department of Neurology & Ophthalmology, Michigan State University, East Lansing, MI, USA; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA. Electronic address: boivin@msu.edu.'}, {'ForeName': 'Limbika', 'Initials': 'L', 'LastName': 'Maliwichi-Senganimalunje', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi; Department of Psychology, Chancellor College, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Lillian W', 'Initials': 'LW', 'LastName': 'Ogwang', 'Affiliation': 'Department of Psychology, Chancellor College, University of Malawi, Zomba, Malawi.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kawalazira', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA; Department of Statistics & Probability, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Familiar-Lopez', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Kuteesa', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Nyakato', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mutebe', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'Jackie L', 'Initials': 'JL', 'LastName': 'Namukooli', 'Affiliation': 'Makerere University-Johns Hopkins University, Kampala, Uganda.'}, {'ForeName': 'MacPherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Ruiseñor-Escudero', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Aizire', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University Medical Institute, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30083-9'] 958,31262657,"Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study.","BACKGROUND Regorafenib confers an overall survival benefit in patients with refractory metastatic colorectal cancer; however, the adverse event profile of regorafenib has limited its use. Despite no supportive evidence, various dosing schedules are used clinically to alleviate toxicities. This study evaluated the safety and activity of two regorafenib dosing schedules. METHODS In this randomised, multicentre, open-label, phase 2 study done in 39 outpatient cancer centres in the USA, adults aged 18 years or older with histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum that was refractory to previous standard therapy, including EGFR inhibitors if KRAS wild-type, were enrolled. Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and had no previous treatment with regorafenib. Patients were randomly assigned (1:1:1:1) into four groups with two distinct regorafenib dosing strategies and two clobetasol usage plans, stratified by hospital. Regorafenib dosing strategies were a dose-escalation strategy (starting dose 80 mg/day orally with weekly escalation, per 40 mg increment, to 160 mg/day regorafenib) if no significant drug-related adverse events occurred and a standard-dose strategy (160 mg/day orally) for 21 days of a 28-day cycle. Clobetasol usage plans (0·05% clobetasol cream twice daily applied to palms and soles) were either pre-emptive or reactive. After randomisation to the four preplanned groups, using the Pocock and Simon dynamic allocation procedures stratified by the treating hospitals, we formally tested the interaction between the two interventions, dosing strategy and clobetasol usage. Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose). The primary endpoint was the proportion of evaluable patients (defined as those who were eligible, consented, and received any protocol treatment) initiating cycle 3 and was analysed per protocol. Superiority for dose escalation was declared if the one-sided p value with Fisher's exact test was less than 0·2. This trial is registered with ClinicalTrials.gov, number NCT02368886. This study is fully accrued but remains active. FINDINGS Between June 2, 2015, and June 22, 2017, 123 patients were randomly assigned to treatment, of whom 116 (94%) were evaluable. The per-protocol population consisted of 54 patients in the dose-escalation group and 62 in the standard-dose group. At data cutoff on July 24, 2018, median follow-up was 1·18 years (IQR 0·98-1·57). The primary endpoint was met: 23 (43%, 95% CI 29-56) of 54 patients in the dose-escalation group initiated cycle 3 versus 16 (26%, 15-37) of 62 patients in the standard-dose group (one-sided p=0·043). The most common grade 3-4 adverse events were fatigue (seven [13%] patients in the dose-escalation group vs 11 [18%] in the standard-dose group), hand-foot skin reaction (eight [15%] patients vs ten [16%] patients), abdominal pain (nine [17%] patients vs four [6%] patients), and hypertension (four [7%] patients vs nine [15%] patients). 14 patients had at least one drug-related serious adverse event: six patients in the dose-escalation group and eight patients in the standard-dose group. There was one probable treatment-related death in the standard-dose group (myocardial infarction). INTERPRETATION The dose-escalation dosing strategy represents an alternative approach for optimising regorafenib dosing with comparable activity and lower incidence of adverse events and could be implemented in clinical practice on the basis of these data. FUNDING Bayer HealthCare Pharmaceuticals.",2019,"Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose).","['Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and had no previous treatment with regorafenib', '39 outpatient cancer centres in the USA, adults aged 18 years or older with histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum that was refractory to previous standard therapy, including EGFR inhibitors if KRAS wild-type, were enrolled', 'patients with refractory metastatic colorectal cancer', '14 patients had at least one drug-related serious adverse event: six patients in the dose-escalation group and eight patients in the standard-dose group', 'Between June 2, 2015, and June 22, 2017, 123 patients were randomly assigned to treatment, of whom 116 (94%) were evaluable', 'patients with refractory metastatic colorectal cancer (ReDOS']","['Clobetasol usage plans (0·05% clobetasol cream', 'Regorafenib dose-optimisation']","['hand-foot skin reaction', 'abdominal pain', 'death', 'hypertension', 'overall survival benefit', 'safety and activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]","[{'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",123.0,0.101255,"Given the absence of a significant interaction (p=0·74), we decided to pool the data for the pre-emptive and reactive treatment with clobetasol and compared the two dosing strategies (dose escalation vs standard dose).","[{'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Phoenix, AZ, USA. Electronic address: bekaii-saab.tanios@mayo.edu.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Boland', 'Affiliation': 'Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ciombor', 'Affiliation': 'Division of Hematology, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Heying', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'Dockter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nisha L', 'Initials': 'NL', 'LastName': 'Jacobs', 'Affiliation': 'Minnesota Oncology, Coon Rapids, MN, USA.'}, {'ForeName': 'Boris C', 'Initials': 'BC', 'LastName': 'Pasche', 'Affiliation': 'Department of Hematology and Oncology, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Rodwige J', 'Initials': 'RJ', 'LastName': 'Desnoyers', 'Affiliation': 'Department of Hematology and Oncology, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeannine S', 'Initials': 'JS', 'LastName': 'McCune', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Pedersen', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'E Gabriela', 'Initials': 'EG', 'LastName': 'Chiorean', 'Affiliation': 'Department of Population Sciences, School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center, Memphis, TN, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30272-4'] 959,31801982,Usefulness of the satiety quotient in a clinical pediatric obesity context.,"BACKGROUND While the satiety quotient (SQ) is increasingly used in pediatric populations, the present study assessed its reliability and reproducibility in adolescents with obesity. METHODS Sixty-eight adolescents with obesity were enrolled. Anthropometric measurements and body composition (DXA) were assessed. They randomly completed two experimental sessions: (i) condition with a standardized breakfast used to calculate SQ (C1); (ii) condition with the same breakfast and ad libitum lunch and dinner buffet meals (C2). Appetite feelings were assessed at regular interval (visual analog scales). RESULTS SQ for hunger (SQH), satiety (SQS), prospective food consumption (SQP), and desire to eat (SQD) were calculated using the breakfast. SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005). None of the SQ was correlated with body weight (BW), BMI, or FM. There was no significant correlation between the SQ and the adolescent's ad libitum energy intake (lunch, dinner, and total). No differences were observed between adolescents with a low and high phenotype for BW, BMI, and FM% (p = 0.26, 0.30, and 0.83); total energy (p = 0.21); total protein intake (p = 0.28); total fat intake (p = 0.24) and total carbohydrate intake (p = 0.44). Thirty percent of the adolescents showed different satiety phenotype (low vs. high) between C1 and C2. CONCLUSIONS While the SQ is a reliable indicator in adults, it must be used with caution in adolescents with obesity due to its lack of association with anthropometric measurements, body composition, and energy and macronutrient intakes in this population.",2020,"SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005).","['Sixty-eight adolescents with obesity were enrolled', 'adolescents with obesity']",['experimental sessions: (i) condition with a standardized breakfast used to calculate SQ (C1); (ii) condition with the same breakfast and ad libitum lunch and dinner buffet meals (C2'],"['satiety phenotype', 'hunger (SQH), satiety (SQS), prospective food consumption (SQP), and desire to eat (SQD', ""adolescent's ad libitum energy intake (lunch, dinner, and total"", 'SQS and SQP', 'total energy', 'total fat intake', 'Appetite feelings', 'SQH, SQD, and SQ mean', 'total carbohydrate intake', 'total protein intake', 'Anthropometric measurements and body composition (DXA', 'body weight (BW), BMI, or FM', 'adolescents with a low and high phenotype for BW, BMI, and FM']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",68.0,0.0330347,"SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France. fillonalicia@gmail.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics unit (DRCI), Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Mathieu', 'Affiliation': 'School of kinesiology and physical activity sciences, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'CRNH-Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0540-8'] 960,31248751,Effect of combination of non-slip element balloon and drug-coating balloon for in-stent restenosis lesions (ELEGANT study).,"BACKGROUND In-stent restenosis (ISR) remains a problematic issue of coronary intervention. The non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal nylon elements which are attached proximally and distally to the balloon component. The expectation is that this design of balloon is able to achieve a larger lumen area due to the elements, as well as reducing balloon slippage. We investigated whether NSE pre-dilatation improves angiographic outcomes compared to a high pressure non-compliant balloon pre-dilatation, followed by a drug-coating balloon (DCB) for treatment of ISR lesions with optical coherence tomographic imaging (OCT). METHODS Patients were eligible for the study if one or more in-stent restenosis lesions were treated with a paclitaxel-coating balloon. Patients were randomized to NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group) in a 1:1 fashion in 17 hospitals. The primary endpoint was in-segment late loss [post minimal lumen diameter (MLD)-follow-up MLD] at 8 months. RESULTS One hundred and five patients were allocated to each group. Balloon slippage (7.9% versus 22.9%, p=0.002) and geographical miss (6.9% versus 21.9%, p=0.002) were observed less in the NSE group compared to the POBA group. Acute gain was significantly larger in the NSE group (1.17±0.42mm versus 1.06±0.35mm, p=0.04), but post minimum stent lumen area analyzed by OCT was similar between the two groups (3.85±1.67mm 2 versus 3.81±1.93mm 2 , p=0.64). At 8 months, average lesion length was significantly shorter than the POBA group (5.78±3.26mm versus 6.97±4.59mm, p=0.04), but average in-segment late loss was similar between the two groups (0.28±0.45mm versus 0.27±0.38mm, p=0.75). CONCLUSION Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions. However, NSE pre-dilatation has advantages such as reduction of balloon slippage and geographical miss during the procedure.",2019,Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions.,"['Patients were eligible for the study if one or more in-stent restenosis lesions', 'One hundred and five patients']","['non-slip element balloon (NSE', 'NSE pre-dilatation', 'paclitaxel-coating balloon', 'NSE pre-dilatation (NSE group) or high pressure non-compliant balloon pre-dilatation (POBA group', 'POBA', 'combination of non-slip element balloon and drug-coating balloon', 'NSE', 'optical coherence tomographic imaging (OCT']","['Acute gain', 'geographical miss', 'average lesion length', 'average in-segment late loss', 'segment late loss [post minimal lumen diameter (MLD)-follow-up MLD', 'Balloon slippage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0304222', 'cui_str': 'Drug coating (product)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023522', 'cui_str': 'Metachromatic Leukoencephalopathy'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]",105.0,0.0375192,Eight-month angiographic outcomes were similar between NSE and non-compliant balloon pre-dilatation with DCB for treatment of ISR lesions.,"[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan. Electronic address: jiro@mitsuihosp.or.jp.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Cardiovascular Center, Kyoto-Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tobaru', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Hisayuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Division of Cardiology, Seirei Hamamatsu General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Zen', 'Affiliation': 'Department of Cardiology, Omihachiman Community Medical Center, Shiga, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': ""Cardiovascular Center, St Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, Itabashi Chuo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Fusazaki', 'Affiliation': 'Division of Cardiology, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.04.011'] 961,32127178,Randomized control trial of opioid- versus nonopioid-based analgesia after thyroidectomy.,"BACKGROUND Opioid-based analgesia is the most common method for pain control in the postoperative period. Limited data exist to compare the adequacy of pain control in the post thyroidectomy period with nonopioid-based analgesia. We aimed to evaluate the efficacy of nonopioid-based, postoperative analgesia. METHODS After institutional review board approval, patients were randomized to 1 of 2 pain control regimens. Sample size was calculated to assess for a pain score difference of 1 based on a visual analog scale. The control group received opioid-based, postoperative analgesia, whereas the study group received nonopioid-based analgesia of acetaminophen and ibuprofen. Pain scores (measured on visual analog scale) and opioid use (converted to morphine equivalent dose) were measured after completion of the operation. RESULTS The sample sizes for the study and control groups were 49 and 46 patients, respectively. The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference. Morphine equivalent opioid requirement for pain control in the postoperative period was 0.8 vs 6.9 mg (P < .01), respectively. CONCLUSION In a randomized control trial, we showed that patients treated with nonopioid analgesia had similar pain scores to those treated with opioids, with the benefit of having lower opioid exposure in the perioperative period.",2020,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.",[],"['nonopioid-based analgesia of acetaminophen and ibuprofen', 'opioid-based, postoperative analgesia', 'opioid- versus nonopioid-based analgesia after thyroidectomy', 'nonopioid analgesia', 'Morphine']","['pain score', 'pain control', 'pain scores', 'Pain scores']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",,0.118298,"The pain score for the study and control groups 1 hour after the operation (3.3 vs 3.9, P = .35), 6 hours after the operation (2.8 vs 3.0, P = .08), on postoperative day 1 (1.6 vs 2.4, P = .08) and on the first office visit (0.2 vs 0.1, P = .82) did not have a statistically significant difference.","[{'ForeName': 'Vardan', 'Initials': 'V', 'LastName': 'Papoian', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC. Electronic address: vpapoian@gmail.com.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Handy', 'Affiliation': 'Department of Anesthesiology, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Villano', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Tolentino', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Mohamed T', 'Initials': 'MT', 'LastName': 'Hassanein', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Nosanov', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Felger', 'Affiliation': 'Department of Surgery, MedStar Georgetown University/Washington Hospital Center, Washington, DC.'}]",Surgery,['10.1016/j.surg.2020.01.011'] 962,31779678,TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives.,"BACKGROUND The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA 1c levels for individuals with T2DM. METHODS/DESIGN TRIPOD is a randomized, open-label, controlled, multi-center, superiority trial with three parallel arms: (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA 1c 7.5-11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA 1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA 1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvement in HbA 1c at Month 12 and converted to cost per quality-adjusted life year gained. DISCUSSION The TRIPOD study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care. TRIAL REGISTRATION ClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.",2019,A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA 1c 7.5-11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms.,"['339 adults with sub-optimally controlled T2DM (self-reported HbA 1c 7.5-11.0', 'individuals with T2DM']","['usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards', 'comprehensive diabetes management package (DMP']","['Incremental cost-effectiveness ratios', 'mean change in HbA 1c level', 'weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0041738', 'cui_str': 'Unithiol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0513836', 'cui_str': 'Weight monitoring (regime/therapy)'}, {'cui': 'C3669205', 'cui_str': 'Blood glucose monitoring'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",339.0,0.0725239,A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA 1c 7.5-11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms.,"[{'ForeName': 'Robyn Su May', 'Initials': 'RSM', 'LastName': 'Lim', 'Affiliation': 'Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Daphne Su Lyn', 'Initials': 'DSL', 'LastName': 'Gardner', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Yong Mong', 'Initials': 'YM', 'LastName': 'Bee', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Bairavi', 'Affiliation': 'Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Su-Yen', 'Initials': 'SY', 'LastName': 'Goh', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Emily Tse Lin', 'Initials': 'ETL', 'LastName': 'Ho', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Ngiap Chuan', 'Initials': 'NC', 'LastName': 'Tan', 'Affiliation': 'Department of Research, SingHealth Polyclinics, 167 Jalan Bukit Merah, Singapore, 150167, Singapore.'}, {'ForeName': 'Tunn Lin', 'Initials': 'TL', 'LastName': 'Tay', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.'}, {'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.'}]",Trials,['10.1186/s13063-019-3749-x'] 963,31779697,Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial.,"BACKGROUND Pruritus in patients undergoing hemodialysis is a highly prevalent complication that affects quality of life. Several medications are currently used for the treatment of uremic pruritus, but these are not satisfactory. PG102P, which is prepared from Actinidia arguta, has an immune-modulating effect on pruritus. This trial is designed to assess the antipruritic effect of PG102P compared with placebo. METHODS This multicenter, randomized, double-blind, placebo-controlled clinical trial will include 80 patients undergoing hemodialysis. The patients will be randomized in a 1:1 ratio to a treatment group (PG102P 1.5 g/day) or a control group (placebo). The treatment will last for 8 weeks, followed by a 2-week observational period. During the observational period, all of the patients will maintain the antipruritic treatment previously used. The primary endpoint will be measured as the difference in visual analog scale between the groups before and after treatment. Secondary outcomes include serum levels of total immunoglobulin E, eosinophil cationic protein, potassium, calcium, phosphorus, intact parathyroid hormone, and blood eosinophil count between weeks 0 and 8. Kidney Disease and Quality of Life and Beck's Depression Inventory questionnaires will be conducted. Safety assessments and any adverse events that occur will also be evaluated. DISCUSSION The SNUG is a clinical study that aims to investigate the antipruritic effect of PG102P to ameliorate itching in patients undergoing hemodialysis. TRIAL REGISTRATION Clinical Trials.gov, NCT03576235. Registered on 4 July 2018.",2019,"PG102P, which is prepared from Actinidia arguta, has an immune-modulating effect on pruritus.","['80 patients undergoing hemodialysis', 'patients undergoing hemodialysis (SNUG trial', 'patients undergoing hemodialysis']","['placebo', 'control group (placebo', 'PG102P']","['serum levels of total immunoglobulin E, eosinophil cationic protein, potassium, calcium, phosphorus, intact parathyroid hormone, and blood eosinophil count', 'Safety and efficacy', ""Kidney Disease and Quality of Life and Beck's Depression Inventory questionnaires"", 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443626', 'cui_str': 'Total immunoglobulin level (finding)'}, {'cui': 'C0950373', 'cui_str': 'Serum Eosinophil Cationic Protein'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0034380'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",80.0,0.453826,"PG102P, which is prepared from Actinidia arguta, has an immune-modulating effect on pruritus.","[{'ForeName': 'Yong Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Dongguk University Ilsan Hospital, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Jae Hyun', 'Initials': 'JH', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Dae Eun', 'Initials': 'DE', 'LastName': 'Choi', 'Affiliation': 'Department of Nephrology, School of Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Jung Tak', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Institute of Kidney Disease Research, Yonsei University, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Pyo', 'Initials': 'JP', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea.'}, {'ForeName': 'Sejoong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Dong Ki', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Dong-Ryeol', 'Initials': 'DR', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Chun Soo', 'Initials': 'CS', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061, Republic of Korea. cslimjy@snu.ac.kr.'}]",Trials,['10.1186/s13063-019-3753-1'] 964,31229045,ATHENA: wisdom and warfare in defining the role of de novo mTOR inhibition in kidney transplantation.,"ATHENA, published in this edition of Kidney International, is the third contemporary, multicenter, randomized, controlled trial to compare de novo use of everolimus, calcineurin inhibitor, and steroids to our current standard of care, mycophenolate, tacrolimus, and steroids, in kidney transplant recipients. This commentary highlights the strengths and significant weaknesses of ATHENA. It then seeks to distill the key messages from the 3 trials, ATHENA, TRANSFORM, and US92, and considers the role of everolimus in kidney transplantation today. Ultimately, the 3 trials demonstrate that everolimus with reduced-concentration tacrolimus and steroids provide a viable alternative to our current standard of care.",2019,"It then seeks to distill the key messages from the 3 trials, ATHENA, TRANSFORM, and US92, and considers the role of everolimus in kidney transplantation today.","['kidney transplantation', 'kidney transplant recipients']","['everolimus, calcineurin inhibitor, and steroids', 'mycophenolate, tacrolimus, and steroids']",[],"[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],,0.0313191,"It then seeks to distill the key messages from the 3 trials, ATHENA, TRANSFORM, and US92, and considers the role of everolimus in kidney transplantation today.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia; Kidney Node, Charles Perkins Centre, University of Sydney, Australia. Electronic address: steve.chadban@health.nsw.gov.au.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Nephrology Division, Hospital do Rim, Universidade Federal de Sao Paulo (UNIFESP), São Paulo, Brazil.'}]",Kidney international,['10.1016/j.kint.2019.04.020'] 965,31420191,Acute declines in estimated glomerular filtration rate on enalapril and mortality and cardiovascular outcomes in patients with heart failure with reduced ejection fraction.,"Angiotensin-converting enzyme inhibitors are beneficial in heart failure with reduced ejection fraction but are associated with acute declines in estimated glomerular filtration rate (eGFR). Prior studies evaluating thresholds of eGFR decline while using angiotensin-converting enzyme inhibitors in heart failure with reduced ejection have not taken into account this medication-driven decline. Here we used data from the Studies of Left Ventricular Dysfunction (SOLVD) trial of 6245 patients and performed Cox proportional hazards regression models to calculate hazard ratios of all-cause mortality and heart failure hospitalization-associated with percent eGFR decline at two- and six-weeks after randomization to enalapril versus placebo. In reference to placebo with equal degree of percent eGFR decline, any eGFR decline in the enalapril arm was associated with lower hazard of both outcomes. Under a conservative estimate using zero percent eGFR decline in the placebo arm as the reference, up to a 10% decline with enalapril was associated with mortality benefit (hazard ratio 0.87 [95% confidence interval 0.77, 0.99]) while up to a 35% decline was associated with decreased risk of heart failure hospitalization (0.78 [0.61, 0.98]). Under an intermediate estimate, up to a 15% decline with enalapril was associated with a mortality benefit (0.86 [0.77, 0.97]) and all levels of eGFR decline were associated with decreased risk of heart failure hospitalization. There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk. Thus, in patients with reduced ejection fraction heart failure, enalapril is associated with decreased risk of mortality and heart failure hospitalizations. Hence, compelling reasons beyond moderate eGFR decline ought to be considered before its use is withdrawn.",2019,"There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk.",['patients with heart failure with reduced ejection fraction'],"['enalapril versus placebo', 'angiotensin-converting enzyme inhibitors', 'Angiotensin-converting enzyme inhibitors', 'placebo', 'enalapril']","['risk of mortality and heart failure hospitalizations', 'mortality benefit', 'percent eGFR decline, any eGFR decline', 'risk of heart failure hospitalization', 'mortality risk', 'eGFR decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]",6245.0,0.0819316,"There was no percent eGFR decline, including up to 40%, in any models at either two- or six-weeks where enalapril was associated with higher mortality risk.","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'McCallum', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Tighiouart', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA; Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ku', 'Affiliation': 'Division of Nephrology and Pediatric Nephrology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Deeb', 'Initials': 'D', 'LastName': 'Salem', 'Affiliation': 'Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts, USA. Electronic address: msarnak@tuftsmedicalcenter.org.'}]",Kidney international,['10.1016/j.kint.2019.05.019'] 966,31223037,Cost-effectiveness of dabrafenib and trametinib in combination as adjuvant treatment of BRAF V600E/K mutation-positive melanoma from a US healthcare payer perspective.,"Objective: The COMBI-AD trial demonstrated the efficacy and safety of dabrafenib and trametinib in combination vs placebo as adjuvant treatment of patients with BRAF V600E/K mutation-positive resected Stage IIIA (lymph node metastasis >1 mm), IIIB, or IIIC melanoma. This analysis evaluated the cost-effectiveness of dabrafenib and trametinib vs observation from a US healthcare payer perspective. Methods: This evaluation employed a non-homogeneous, semi-Markov, cohort model with health states for relapse-free survival (RFS), post-locoregional recurrence (LR), post-distant recurrence (DR) receiving first-line treatment, and post-DR receiving second-line treatment. A 50-year modeling time horizon was used. Transition probabilities were estimated based on individual patient data (IPD) from the COMBI-AD trial. Health-state utilities were estimated using EuroQol (EQ-5D) index values from COMBI-AD and published sources. Direct medical costs associated with treatment of melanoma were considered, including costs of BRAF mutation testing, medication and administration costs for adjuvant and metastatic treatments, costs of treating recurrence, and costs of adverse events. Costs and quality-adjusted life-years (QALYs) were discounted at 3.0% annually. Results: Compared with observation, adjuvant dabrafenib and trametinib was estimated to result in a gain of 2.15 QALYs at an incremental cost of $74,518. The incremental cost-effectiveness ratio (ICER) was estimated to be $34,689 per QALY. In deterministic sensitivity analyses, the ICER was sensitive to the cost of dabrafenib and trametinib and the distribution used for projecting RFS beyond the end of follow-up in the COMBI-AD trial. At a cost-effectiveness threshold of $100,000 per QALY, the probability that dabrafenib and trametinib is cost-effective was estimated to be 92%. Conclusions: Given generally-accepted cost-effectiveness threshold values in the US, dabrafenib plus trametinib is likely to be a cost-effective adjuvant therapy for patients with BRAF mutation positive melanoma. These results may be useful for policy-makers in their deliberations regarding reimbursement and access to this treatment.",2019,"In deterministic sensitivity analyses, the ICER was sensitive to the cost of dabrafenib and trametinib and the distribution used for projecting RFS beyond the end of follow-up in the COMBI-AD trial.","['patients with BRAF V600E/K mutation-positive resected Stage IIIA (lymph node metastasis >1\u2009mm), IIIB, or IIIC melanoma', 'patients with BRAF mutation positive melanoma']","['dabrafenib and trametinib', 'placebo', 'dabrafenib and trametinib vs observation']","['Health-state utilities', 'cost-effective', 'Costs and quality-adjusted life-years (QALYs', 'relapse-free survival (RFS), post-locoregional recurrence (LR), post-distant recurrence (DR', 'incremental cost-effectiveness ratio (ICER', 'costs of BRAF mutation testing, medication and administration costs for adjuvant and metastatic treatments, costs of treating recurrence, and costs of adverse events', 'efficacy and safety', 'Transition probabilities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.225307,"In deterministic sensitivity analyses, the ICER was sensitive to the cost of dabrafenib and trametinib and the distribution used for projecting RFS beyond the end of follow-up in the COMBI-AD trial.","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stellato', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}, {'ForeName': 'Sameer R', 'Initials': 'SR', 'LastName': 'Ghate', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, NJ, USA.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Ndife', 'Affiliation': 'Novartis Pharmaceuticals Corp, East Hanover, NJ, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Moynahan', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Novartis Pharmaceuticals Corp, Hyderabad, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Gunda', 'Affiliation': 'Novartis Pharmaceuticals Corp, Hyderabad, India.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Koruth', 'Affiliation': 'Novartis Pharmaceuticals Corp, Hyderabad, India.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Delea', 'Affiliation': 'Policy Analysis Inc. (PAI), Brookline, MA, USA.'}]",Journal of medical economics,['10.1080/13696998.2019.1635487'] 967,31262371,"Effects of n -3 PUFA on endothelial function in patients with peripheral arterial disease: a randomised, placebo-controlled, double-blind trial.","As only limited evidence is available for potential benefits of n-3 PUFA supplementation in patients with peripheral arterial disease (PAD), we studied the effects of 4 g n-3 PUFA on endothelial function and inflammatory markers. Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors were randomised to receive either 4 g n-3 PUFA or placebo daily for 3 months in a double-blind fashion. Primary endpoint was endothelial function assessed by flow-mediated vasodilation (FMD). In addition, ankle-brachial index, maximum and pain-free walking distances were determined. Lipid parameters including the omega-3 index reflecting n-3 PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers were measured over the same time interval. After 3 months of treatment with 4 g n-3 PUFA daily, a significant improvement of FMD was observed compared with placebo (n-3 PUFA, median Δ 3·7 (interquartile range (IQR) -1·8, 7·1) % v. placebo, Δ -0·5 (IQR -6·5, 3·0) %, P = 0·01 between the groups). After a 3-month washout period, this benefit was not sustained (n-3 PUFA, median Δ 0·6 (IQR -2·2, 5·6) % v. placebo, Δ -0·9 (IQR -6·6, 6·7) %, P = 0·20). In response to n-3 PUFA, an improvement of lipid parameters with a pronounced increase in the omega-3 index was seen. No changes were found for other parameters. In conclusion, in patients with PAD, 4 g/d n-3 PUFA improved cardiovascular risk in PAD patients, which needs testing in large-scale trials.",2019,"In response to n3-PUFA, an improvement of lipid parameters with a pronounced increase of omega-3 index was seen.","['Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors', 'patients with peripheral arterial disease (PAD', 'Patients with Peripheral Arterial Disease']","['N3-PUFA supplementation', 'n3-PUFA or placebo', 'placebo', 'Placebo', 'omega-3 polyunsaturated fatty acids (n3-PUFA) supplementation', 'Omega-3-Polyunsaturated Fatty']","['FMD', 'endothelial function', 'endothelial function assessed by flow-mediated vasodilation (FMD', 'omega-3 index reflecting n3-PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers', 'Endothelial Function', 'ankle-brachial index (ABI), maximum and pain-free walking distances', 'omega-3 index']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",70.0,0.502667,"In response to n3-PUFA, an improvement of lipid parameters with a pronounced increase of omega-3 index was seen.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Deddo', 'Initials': 'D', 'LastName': 'Moertl', 'Affiliation': 'Karl Landsteiner Institute for the Research of Ischemic Cardiac Diseases and Rhythmology, St. Poelten, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schlager', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Matschuck', 'Affiliation': 'Department of Angiology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Seidinger', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Koppensteiner', 'Affiliation': 'Division of Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steiner', 'Affiliation': 'Department of Angiology, University Hospital Leipzig, Leipzig, Germany.'}]",The British journal of nutrition,['10.1017/S0007114519001582'] 968,31802404,"A Phase I, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics, Safety, and Tolerability of Cannabidiol in Subjects with Mild to Severe Renal Impairment.","INTRODUCTION As patients who receive cannabidiol (CBD) may have co-existing renal morbidities, it is important to understand whether dose adjustments are necessary to mitigate the risk of exposure-related toxicity. This study was conducted to evaluate the pharmacokinetics, safety, and tolerability of CBD in patients with renal impairment. METHODS The pharmacokinetics and safety of a single oral 200 mg dose of a plant-derived pharmaceutical formulation of highly purified CBD in oral solution (Epidiolex ® in the USA; 100 mg/mL) were assessed in subjects with mild, moderate, or severe renal impairment (n = 8/group) relative to matched subjects with normal renal function (n = 8). Blood samples were collected until 48 h post-dose and evaluated by liquid chromatography with tandem mass spectrometry. Analysis of variance was used to compare primary pharmacokinetic parameters (maximum measured plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample [Ae last ], and fraction of the systemically available drug excreted into the urine [f e ]). RESULTS No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD (6-OH-CBD); geometric mean ratio for C max values ranged from 0.68 to 1.35. No differences were observed for other secondary parameters (Ae last and f e ). CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD were highly protein bound (> 90%); binding was similar in all subject groups. Urine analysis for CBD recorded no appreciable amount, and thus no urinary pharmacokinetic parameters could be derived. Adverse events (AEs) affected two subjects; all five AEs were mild in severity and resolved during the trial. There were no serious AEs or discontinuations due to AEs. Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings were not clinically significant. CONCLUSION Renal impairment had no effect on the metabolism of CBD after a single oral 200 mg dose. CBD was generally well tolerated in subjects with varying degrees of renal function. REGISTRATION European Union Clinical Trials Register (EudraCT) no. 2015-002122-39.",2020,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","['subjects with mild, moderate, or severe renal impairment (n\u2009=\u20098/group) relative to matched subjects with normal renal function (n\u2009=\u20098', 'subjects with varying degrees of renal function', 'patients with renal impairment', 'Subjects with Mild to Severe Renal Impairment']","['CBD', 'cannabidiol (CBD']","['plasma concentration [C max ], oral clearance of drug from plasma [CL/F], renal clearance [CL R ], area under the plasma concentration-time curve [AUC] from time zero to last measurable concentration [AUC t ], and AUC from time zero to infinity [AUC ∞ ]); descriptive analysis was used for secondary pharmacokinetic parameters (time to C max [t max ], terminal [elimination] half-life [t ½ ], cumulative amount excreted from time zero to the last quantifiable sample', 'CBD, 7-COOH-CBD, 7-OH-CBD, and 6-OH-CBD', 'normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD', 'Blood samples', 'metabolism of CBD', 'pharmacokinetics, safety, and tolerability of CBD', 'Laboratory, physical examination, vital sign, and 12-lead electrocardiogram findings', 'C max , AUC t , AUC ∞ , or t max values']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0518766'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.055322,"No statistically significant differences were observed in C max , AUC t , AUC ∞ , or t max values between subjects with mild, moderate, or severe renal impairment and subjects with normal renal function for CBD or its major metabolites, 7-carboxy-CBD (7-COOH-CBD) and 7-hydroxy-CBD (7-OH-CBD), and minor metabolite, 6-hydroxy-CBD","[{'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Sahebkar', 'Affiliation': 'Greenwich Biosciences, Inc., 5750 Fleet Street, Suite 200, Carlsbad, CA, 92008, USA.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Sovereign House, Vision Park, Histon, Cambridge, CB24 9BZ, UK. GMorrison@gwpharm.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00841-6'] 969,31779675,The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial.,"BACKGROUND Vitamin D deficiency has been shown to be closely associated with peritoneal dialysis (PD)-related peritonitis. The aim of this study is to examine the feasibility of conducting a large, powered randomized controlled trial to determine the effects of vitamin D supplementation on the risk of PD-related peritonitis in patients who have already experienced an episode of peritonitis. METHODS This prospective, open-label randomized controlled pilot trial with blinded end-points aims to determine the feasibility of oral vitamin D supplementation and to explore its effects on the risk of subsequent PD-related peritonitis among PD patients who have recovered from a recent episode of peritonitis. Eligible patients will be randomized 1:1 to either oral vitamin D supplementation (2000 IU per day; intervention group) or no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis guidelines. The sample size will be 30 patients for both groups. All participants will be followed for 12 months. The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future. Secondary outcomes include time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30 days of peritonitis onset). DISCUSSION This is the first randomized controlled trail investigating the effects of vitamin D supplementation on the risk of subsequent PD-related peritonitis among patients on PD. The findings for this pilot study will determine the feasibility of conducting a full-scale randomized controlled trail, which may provide a new strategy for preventing PD-related peritonitis among PD patients. TRIAL REGISTRATION Clinicaltrails.gov, NCT03264625. Registered on 29 August 2017.",2019,"The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future.","['patients on PD', 'patients who have already experienced an episode of peritonitis', 'peritoneal dialysis-related peritonitis', 'PD patients', 'Eligible patients', 'PD patients who have recovered from a recent episode of peritonitis']","['no vitamin D supplementation (control group) in addition to usual care according to International Society for Peritoneal Dialysis guidelines', 'vitamin D supplementation', 'vitamin D', 'oral vitamin D supplementation']","['assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level', 'risk of PD-related peritonitis', 'time to peritonitis occurrence, recovery of peritonitis, peritonitis-related transition to hemodialysis, and peritonitis-related death (defined as death within 30\u2009days of peritonitis onset']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.190915,"The primary outcome is the assessment of feasibility (recruitment success, retention, adherence, safety) and fidelity (change in serum 25-hydroxyvitamin D level during follow-up) for a large, powered randomized controlled trial to determine the effects of vitamin D on the risk of PD-related peritonitis in the future.","[{'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Hai-Chen', 'Initials': 'HC', 'LastName': 'Pi', 'Affiliation': 'Department of Emergency Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Zhi-Kai', 'Initials': 'ZK', 'LastName': 'Yang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China. jie.dong@bjmu.edu.cn.'}]",Trials,['10.1186/s13063-019-3784-7'] 970,31235418,A randomized unblinded trial to compare effects of intensive versus conventional lipid-lowering therapy in patients undergoing renal artery stenting.,"BACKGROUND Although current guidelines recommend the use of statins for severe atherosclerotic renal artery stenosis (ARAS), the renal protection of intensive lipid-lowering therapy in patients with ARAS who underwent stent placement remains uncertain. The aim of this study was to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients with ARAS undergoing stent placement. METHODS A total 150 patients with severe ARAS undergoing stent placement were randomly (1:1) assigned to receive intensive lipid lowering [target low-density lipoprotein cholesterol (LDL-C) <70mg/dL] or conventional lipid lowering (target LDL-C ≥70mg/dL, <128mg/dL). All patients received rosuvastatin. We adjusted LDL-C to the goal within two months after renal stenting and maintained stability. The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months. RESULTS During the study period, LDL-C was lower in the patients with intensive lipid lowering than with conventional lipid lowering (at 12 months 58.0±11.6 vs 85.1±15.5mg/dL, p<0.001). At 12-month follow-up, eGFR (91.8±30.2 vs 78.5±19.5)mL/min·1.73m 2 , p=0.002) and the increase in eGFR compared to baseline [14.8(IQR, 4.1, 26.7) vs -0.4(IQR, -9.5, 8.0)mL/min·1.73m 2 , p<0.001] were higher in the patients with intensive lipid lowering than with conventional lipid lowering. Urinary albumin-creatinine ratio [42.2(IQR, 20.0, 60.9) vs 60.8(IQR, 26.8, 121.6)mg/g, p=0.032] was lower and the decrease in urinary albumin-creatinine ratio compared to baseline [27.4(IQR, 3.0, 53.8) vs -3.1(IQR, -17.3, 30.9)mg/g, p=0.001] was higher in the patients with intensive lipid lowering than with conventional lipid lowering. The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups. CONCLUSIONS In patients with severe ARAS undergoing stent placement, intensive lipid lowering showed significant benefits in renal protection over conventional lipid-lowering therapy.",2019,"The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups. ","['patients undergoing renal artery stenting', 'patients with ARAS who underwent stent placement remains uncertain', 'patients with severe ARAS undergoing', 'patients with ARAS undergoing stent placement', 'A total 150 patients with severe ARAS undergoing stent placement', 'severe atherosclerotic renal artery stenosis (ARAS']","['intensive lipid lowering with that of conventional lipid lowering', 'intensive lipid lowering [target low-density lipoprotein cholesterol (LDL-C) <70mg/dL] or conventional lipid lowering (target LDL-C ≥70mg/dL, <128mg/dL', 'stent placement, intensive lipid lowering', 'intensive versus conventional lipid-lowering therapy', 'rosuvastatin']","['urinary albumin-creatinine ratio', 'Urinary albumin-creatinine ratio', 'restenosis rate', 'eGFR', 'change in estimated glomerular filtration rate (eGFR', 'major clinical events', 'renal protection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0340557', 'cui_str': 'Atherosclerotic renal artery stenosis (disorder)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3811844'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",150.0,0.188818,"The restenosis rate (3.1% vs 3.4%, p=0.711) and major clinical events (6.8% vs 11.0%, p=0.37) were similar between the two groups. ","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiongjing', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiangxiongjing@163.com.'}, {'ForeName': 'Wuqiang', 'Initials': 'W', 'LastName': 'Che', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yubao', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.04.010'] 971,31262189,"Phytosterol enhances oral nifedipine treatment in pregnancy-induced preeclampsia: A placebo-controlled, double-blinded, randomized clinical trial.",,2019,,['pregnancy-induced preeclampsia'],"['placebo', 'Phytosterol enhances oral nifedipine']",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]",[],,0.779672,,"[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynecology, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Huanrong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynecology, Liaocheng People's Hospital, Liaocheng 252000, China.""}]","Experimental biology and medicine (Maywood, N.J.)",['10.1177/1535370219861574'] 972,30539221,Clinical and radiologic outcomes of two patellar resection techniques during total knee arthroplasty: a prospective randomized controlled study.,"PURPOSE A cutting guide technique for patella resurfacing in total knee arthroplasty was expected to result in less patellofemoral syndromes. The aim of this study was to identify differences in the patellofemoral function, clinical outcomes, and radiographic parameters between the freehand and cutting guide patellar resection techniques in patients undergoing total knee arthroplasty. METHODS A prospective randomized controlled trial was conducted. The study was registered in a public trials registry (International Standard Randomized Trial No. NCT02268097). One-hundred total knee arthroplasties in 100 patients were randomly allocated into one of the two groups, and their results were followed for a mean of 28 months (range, 18 to 38 months) in a double-blind (both patient and evaluator), prospective study. Evaluation was performed by an independent observer using patellofemoral functional capacity, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, and radiographic examination. RESULTS In total, 14% of the patients were lost to follow-up. There was no difference in the incidence of anterior knee pain between the two groups. No patients received or required revisions. There was a significant difference in the outliers of lateral patellar tilt between the freehand and cutting guide groups (> 10°) (p = 0.036); however, the mean value of lateral patellar tilt did not differ significantly. There were no differences between groups with respect to the 30 seconds stair climbing test, complications, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, patient satisfaction, physical examination, hip-knee-ankle angle, lateral patellar displacement, or the Insall-Salvati ratio. Meanwhile, gender, age, weight, height, body mass index, pre-operative Knee Society scores, and pre-operative range of motion were not found to be related to the development of anterior knee pain. CONCLUSIONS Cutting guide technique group did not yield lower incidence of anterior knee pain. More outliers of lateral patellar tilt were observed in the freehand technique group. Overall, all patients in both groups had identical results in terms of patellofemoral functional capacity, clinical outcomes, and other radiographic results.",2019,"There were no differences between groups with respect to the 30 seconds stair climbing test, complications, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, patient satisfaction, physical examination, hip-knee-ankle angle, lateral patellar displacement, or the Insall-Salvati ratio.","['One-hundred total knee arthroplasties in 100 patients', 'patients undergoing total knee arthroplasty', 'total knee arthroplasty']","['patellar resection techniques', 'freehand and cutting guide patellar resection techniques']","['outliers of lateral patellar tilt', 'lateral patellar tilt', 'patellofemoral functional capacity, clinical outcomes, and other radiographic results', 'mean value of lateral patellar tilt', 'anterior knee pain', 'incidence of anterior knee pain', 'patellofemoral function, clinical outcomes, and radiographic parameters', 'patellofemoral functional capacity, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, and radiographic examination', 'patellofemoral syndromes', '30 seconds stair climbing test, complications, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, patient satisfaction, physical examination, hip-knee-ankle angle, lateral patellar displacement, or the Insall-Salvati ratio']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral Pain Syndrome'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",100.0,0.0432628,"There were no differences between groups with respect to the 30 seconds stair climbing test, complications, the Knee Society clinical rating system, the Western Ontario and McMaster Universities Osteoarthritis Indices, patient satisfaction, physical examination, hip-knee-ankle angle, lateral patellar displacement, or the Insall-Salvati ratio.","[{'ForeName': 'Fuzhen', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Institution of Sports Medicine, Beijing Key Laboratory of Sports Injuries, Peking University Third Hospital, No. 49 North, Garden Road, Haidian, Beijing, 100191, China.'}, {'ForeName': 'Zewen', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Institution of Sports Medicine, Beijing Key Laboratory of Sports Injuries, Peking University Third Hospital, No. 49 North, Garden Road, Haidian, Beijing, 100191, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Institution of Sports Medicine, Beijing Key Laboratory of Sports Injuries, Peking University Third Hospital, No. 49 North, Garden Road, Haidian, Beijing, 100191, China.'}, {'ForeName': 'Yourong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institution of Sports Medicine, Beijing Key Laboratory of Sports Injuries, Peking University Third Hospital, No. 49 North, Garden Road, Haidian, Beijing, 100191, China.'}, {'ForeName': 'Jiakuo', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Institution of Sports Medicine, Beijing Key Laboratory of Sports Injuries, Peking University Third Hospital, No. 49 North, Garden Road, Haidian, Beijing, 100191, China. yujiakuo@126.com.'}]",International orthopaedics,['10.1007/s00264-018-4264-5'] 973,31801031,"Comparative Study of Implantable Collamer Lens Implantation in Treating Four Degrees of Myopia: Six-Month Observation of Visual Results, Higher-Order Aberrations, and Amplitude of Accommodation.","PURPOSE To compare the visual and refractive outcomes, higher-order aberrations (HOAs), and amplitude of accommodation (AA) after implantable collamer lens (ICL) model V4c implantation in four degrees of myopia. METHODS One hundred and thirty-seven myopic eyes (137 patients) undergoing ICL implantation were included and divided into four groups: Group 1 with spherical equivalent (SE) ≤-6.0D, Group 2 with SE from -6.13D to -9.0D, Group 3 with SE from -9.13D to -12.0D, and Group 4 with SE from -12.13D to -18.0D. The postoperative visits were scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months. Visual and refractive outcomes, HOAs and AA were observed and compared. RESULTS At 6 months postoperatively, the uncorrected distance visual acuity (UDVA) in Group 4 was worse than the values in the other groups (all p < .05). Meanwhile, Group 4 had more eyes with corrected distance visual acuity (CDVA) improvement than the other groups. Furthermore, 96%, 100%, 100%, and 81% of eyes had an SE within ±0.5D in Group 1, Group 2, Group 3, and Group 4 ( p < .05 between Group 4 and the other groups), respectively. The postoperative UDVA and SE remained stable in all groups. No significant change in total HOAs was found between preoperative and postoperative values for each group. However, quatrefoil increased in each group, whereas trefoil was induced in all groups except for Group 1. Negative spherical aberration was induced in Group 3 and Group 4. AA significantly decreased 1 week postoperatively and gradually improved in each group. Although AA improved to the preoperative level in Group 1 at 3 months postoperatively, it was still lower than the preoperative level in the other groups. CONCLUSIONS In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.",2020,"In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.","['4 degrees of myopia', 'Methods One hundred and forty-two myopic eyes (142 patients) undergoing ICL implantation', 'Treating Four Degrees of Myopia']","['Implantable Collamer Lens Implantation', 'implantable collamer lens (ICL) model V4c implantation']","['uncorrected distance visual acuity (UDVA', 'Visual and refractive outcomes, HOAs and AA', 'Negative spherical aberration', 'postoperative visits', 'CDVA improvement, SE predictability, HOAs induction, and accommodation recovery', 'visual and refractive outcomes, higher order aberrations (HOAs), and amplitude of accommodation (AA', 'postoperative UDVA and SE', 'total HOAs', 'corrected distance visual acuity (CDVA) improvement', 'Visual Results, Higher Order Aberrations, and Amplitude of Accommodation', 'quatrefoil']","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",142.0,0.0241137,"In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wan', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Houfa', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Yabo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}]",Current eye research,['10.1080/02713683.2019.1701690'] 974,31200945,Results from the randomized controlled IHOPE trial suggest no effects of oral protein supplementation and exercise training on physical function in hemodialysis patients.,"Few long-term studies have assessed whether changes in both diet and exercise can improve the health and quality of life (QOL) of hemodialysis (HD) patients. Here we examined whether 12 months of intradialytic protein supplementation and endurance exercise improves physical function, risk of cardiovascular disease (CVD), and QOL in HD patients in a randomized controlled trial (RCT). A total of 138 HD patients (average age 58 years) were assigned for 12 months to control, intradialytic protein, or protein plus exercise groups. The protein and protein plus exercise groups consumed an oral protein supplement (30 grams of whey) three days/week during dialysis. The protein plus exercise group cycled for 30-45 minutes during dialysis treatment. The primary outcome was change in physical function at 12 months, assessed by a shuttle walk test. Secondary outcomes included arterial stiffness, blood pressure, body composition, muscle strength, markers of nutritional status, and QOL. Assessments were conducted at baseline, 6 and 12 months. In total, 101 patients completed the intervention. There were no significant differences between groups in shuttle walk test performance from baseline to 12 months. There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance. Thus, our trial did not demonstrate significant improvements in markers of physical function, risk of CVD or QOL after one year of intradialytic oral OPS and aerobic exercise training. More comprehensive lifestyle management may be needed to uncover robust improvements in the health and QOL of HD patients.",2019,"There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance.","['138 HD patients (average age 58 years', 'hemodialysis patients', '101 patients completed the intervention']","['oral protein supplement', 'control, intradialytic protein, or protein plus exercise groups', 'oral protein supplementation and exercise training', 'intradialytic protein supplementation and endurance exercise']","['physical function', 'health and quality of\xa0life (QOL', 'shuttle walk test performance', 'markers of physical function, risk of CVD or QOL', 'physical function and strength', 'physical function, risk of cardiovascular disease (CVD), and QOL', 'arterial stiffness, blood pressure, body composition, muscle strength, markers of nutritional status, and QOL', 'change in physical function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",138.0,0.0452191,"There were trends for improvements in some secondary measures of physical function and strength in the protein and protein plus exercise groups at six or 12 months, but these did not reach statistical significance.","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Biruete', 'Affiliation': 'Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Tomayko', 'Affiliation': 'School of Biological and Population Health Sciences, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Pei Tzu', 'Initials': 'PT', 'LastName': 'Wu', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fitschen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Hae Ryong', 'Initials': 'HR', 'LastName': 'Chung', 'Affiliation': 'College of Health, Clayton State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Fernhall', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'College of Applied Health Science, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Wilund', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA; Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA. Electronic address: kwilund@illinois.edu.'}]",Kidney international,['10.1016/j.kint.2019.03.018'] 975,31678833,"Acute and residual effects of smoked cannabis: Impact on driving speed and lateral control, heart rate, and self-reported drug effects.","BACKGROUND Although driving under the influence of cannabis is increasingly common among young adults, little is known about residual effects on driver behavior. This study examined acute and residual effects of smoked cannabis on simulated driving performance of young cannabis users. METHODS In this double-blind, placebo-controlled, parallel-group randomized clinical trial, cannabis users (1-4 days/week) aged 19-25 years were randomized with a 2:1 allocation ratio to receive active (12.5% THC) or placebo (0.009% THC) cannabis in a single 750 mg cigarette. A median split (based on whole-blood THC concentrations at the time of driving) was used to divide the active group into low and high THC groups. Our primary outcome was simulated driving performance, assessed 30 min and 24 and 48 h after smoking. Secondary outcomes included blood THC concentrations, subjective drug effects, and heart rate. RESULTS Ninety-six participants were randomized, and 91 were included in the final analysis (30 high THC, 31 low THC, 30 placebo). Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo. Heart rate, VAS drug effect and drug high increased significantly immediately after smoking cannabis and declined steadily after that. There was little evidence of residual effects in any of the measures. CONCLUSION Acutely, cannabis caused decreased speed, increased heart rate, and increases in VAS drug effect and drug high. There was no evidence of residual effects on these measures over the two days following cannabis administration.",2019,Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo.,"['smoked cannabis', 'Ninety-six participants were randomized, and 91 were included in the final analysis (30 high THC, 31 low THC, 30 placebo', 'young adults', 'young cannabis users', 'cannabis users (1-4 days/week) aged 19-25 years']","['placebo', 'smoked cannabis', 'placebo (0.009% THC) cannabis in a single 750\u202fmg cigarette']","['Mean speed', 'simulated driving performance', 'driving speed and lateral control, heart rate, and self-reported drug effects', 'VAS drug effect', 'Heart rate, VAS drug effect and drug high increased significantly immediately after smoking cannabis', 'heart rate', 'blood THC concentrations, subjective drug effects, and heart rate']","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0936079', 'cui_str': 'Hemp Plant'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0005768'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",96.0,0.409585,Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo.,"[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Controlled Substances Directorate, Health Canada, Ottawa, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada. Electronic address: Bruna.Brands@canada.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario, M5S3M2, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Pharmacy, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.'}, {'ForeName': 'Gillian S', 'Initials': 'GS', 'LastName': 'Sayer', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Burston', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Jie Fei', 'Initials': 'JF', 'LastName': 'Pan', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Stefan', 'Affiliation': 'Clinical Laboratory and Diagnostic Services, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'The Lambert Center for the Study of Medicinal Cannabis and Hemp, Thomas Jefferson University, 1020 Walnut Street Philadelphia, PA 19107, United States.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario, M5G 1V7, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario, M5S 1A8, Canada.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107641'] 976,32410398,Retraction: Cervical mucus removal prior to intrauterine insemination: a randomized trial.,,2020,,[],['Retraction: Cervical mucus removal prior to intrauterine insemination'],[],[],"[{'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]",[],,0.0306512,,[],BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16164'] 977,32410400,Expression of concern: Nifedipine alone or combined with sildenafil citrate for management of threatened preterm labour: a randomised trial.,,2020,,['threatened preterm labour'],['Nifedipine alone or combined with sildenafil citrate'],[],"[{'cui': 'C0022876', 'cui_str': 'Premature labor'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}]",[],,0.271786,,[],BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16082'] 978,31221619,"Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study.","BACKGROUND Immunotherapy combination treatments can improve patient outcomes. Epacadostat, an IDO1 selective inhibitor, and pembrolizumab, a PD-1 inhibitor, showed promising antitumour activity in the phase 1-2 ECHO-202/KEYNOTE-037 study in advanced melanoma. In this trial, we aimed to compare progression-free survival and overall survival in patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab. METHODS In this international, randomised, placebo-controlled, double-blind, parallel-group, phase 3 trial, eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600 mutant status or consented to BRAF V600 mutation testing during screening. Patients were stratified by PD-L1 expression and BRAF V600 mutation status and randomly assigned (1:1) through a central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab for up to 2 years. We used block randomisation with a block size of four in each stratum. Primary endpoints were progression-free survival and overall survival in the intention-to-treat population. The safety analysis population included randomly assigned patients who received at least one dose of study treatment. The study was stopped after the second interim analysis; follow-up for safety is ongoing. This study is registered with ClinicalTrials.gov, number NCT02752074. FINDINGS Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients were randomly assigned to receive epacadostat plus pembrolizumab (n=354) or placebo plus pembrolizumab (n=352). Median follow-up was 12·4 months (IQR 10·3-14·5). No significant differences were found between the treatment groups for progression-free survival (median 4·7 months, 95% CI 2·9-6·8, for epacadostat plus pembrolizumab vs 4·9 months, 2·9-6·8, for placebo plus pembrolizumab; hazard ratio [HR] 1·00, 95% CI 0·83-1·21; one-sided p=0·52) or overall survival (median not reached in either group; epacadostat plus pembrolizumab vs placebo plus pembrolizumab: HR 1·13, 0·86-1·49; one-sided p=0·81). The most common grade 3 or worse treatment-related adverse event was lipase increase, which occurred in 14 (4%) of 353 patients receiving epacadostat plus pembrolizumab and 11 (3%) of 352 patients receiving placebo plus pembrolizumab. Treatment-related serious adverse events were reported in 37 (10%) of 353 patients receiving epacadostat plus pembrolizumab and 32 (9%) of 352 patients receiving placebo plus pembrolizumab. There were no treatment-related deaths in either treatment group. INTERPRETATION Epacadostat 100 mg twice daily plus pembrolizumab did not improve progression-free survival or overall survival compared with placebo plus pembrolizumab in patients with unresectable or metastatic melanoma. The usefulness of IDO1 inhibition as a strategy to enhance anti-PD-1 therapy activity in cancer remains uncertain. FUNDING Incyte Corporation, in collaboration with Merck Sharp & Dohme.",2019,Median follow-up was 12·4 months,"['Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients', 'Patients were stratified by PD-L1 expression and BRAF V600 mutation status and randomly assigned (1:1) through a', 'eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600 mutant status or consented to BRAF V600 mutation testing during screening', 'patients with unresectable or metastatic melanoma', 'patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252', 'patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab']","['epacadostat plus pembrolizumab', 'central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab', 'placebo', 'Epacadostat plus pembrolizumab', 'IDO1 inhibition', 'placebo plus pembrolizumab', 'pembrolizumab']","['progression-free survival', 'progression-free survival and overall survival', 'progression-free survival or overall survival', 'serious adverse events', 'deaths', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",928.0,0.7993,Median follow-up was 12·4 months,"[{'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Department of Pathology, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Caglevic', 'Affiliation': 'Oncology Department, Clinica Alemana Santiago, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils De Lyon, Cancer Research Center of Lyon, Claude Bernard University Lyon, Pierre Benite, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Service de Dermatologie et Cancérologie Cutanée, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Haemato-Oncology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Comprehensive Cancer Center, Villejuif, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Diede', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30274-8'] 979,31221620,"MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial.","BACKGROUND Approximately 15% of all breast cancers occur in women with a family history of breast cancer, but for whom no causative hereditary gene mutation has been found. Screening guidelines for women with familial risk of breast cancer differ between countries. We did a randomised controlled trial (FaMRIsc) to compare MRI screening with mammography in women with familial risk. METHODS In this multicentre, randomised, controlled trial done in 12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type. Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded. Participants were randomly allocated (1:1) to receive either annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group). Randomisation was done via a web-based system and stratified by centre. Women who did not provide consent for randomisation could give consent for registration if they followed either the mammography group protocol or the MRI group protocol in a joint decision with their physician. Results from the registration group were only used in the analyses stratified by breast density. Primary outcomes were number, size, and nodal status of detected breast cancers. Analyses were done by intention to treat. This trial is registered with the Netherlands Trial Register, number NL2661. FINDINGS Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration. 675 of 1355 women were randomly allocated to the MRI group and 680 to the mammography group. 218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group. The mean number of screening rounds per woman was 4·3 (SD 1·76). More breast cancers were detected in the MRI group than in the mammography group (40 vs 15; p=0·0017). Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023). Tumour stages of the cancers detected at incident rounds were significantly earlier in the MRI group (12 [48%] of 25 in the MRI group vs one [7%] of 15 in the mammography group were stage T1a and T1b cancers; one (4%) of 25 in the MRI group and two (13%) of 15 in the mammography group were stage T2 or higher; p=0·035) and node-positive tumours were less frequent (two [11%] of 18 in the MRI group vs five [63%] of eight in the mammography group; p=0·014). All seven tumours stage T2 or higher were in the two highest breast density categories (breast imaging reporting and data system categories C and D; p=0·0077) One patient died from breast cancer during follow-up (mammography registration group). INTERPRETATION MRI screening detected cancers at an earlier stage than mammography. The lower number of late-stage cancers identified in incident rounds might reduce the use of adjuvant chemotherapy and decrease breast cancer-related mortality. However, the advantages of the MRI screening approach might be at the cost of more false-positive results, especially at high breast density. FUNDING Dutch Government ZonMw, Dutch Cancer Society, A Sister's Hope, Pink Ribbon, Stichting Coolsingel, J&T Rijke Stichting.",2019,Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023).,"['women with familial risk (FaMRIsc', '12 hospitals in the Netherlands, women were eligible to participate if they were aged 30-55 years and had a cumulative lifetime breast cancer risk of at least 20% because of a familial predisposition, but were BRCA1, BRCA2, and TP53 wild-type', '218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group', '675 of 1355 women', 'women with a family history of breast cancer', 'Participants who were breast-feeding, pregnant, had a previous breast cancer screen, or had a previous a diagnosis of ductal carcinoma in situ were eligible, but those with a previously diagnosed invasive carcinoma were excluded', 'women with familial risk', 'Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration', 'women with familial risk of breast cancer differ between countries']","['MRI', 'annual MRI and clinical breast examination plus biennial mammography (MRI group) or annual mammography and clinical breast examination (mammography group', 'MRI screening with mammography', 'MRI versus mammography']","['mean number of screening rounds per woman was 4·3', 'Invasive cancers', 'number, size, and nodal status of detected breast cancers', 'breast cancers']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1261325', 'cui_str': 'Family history of malignant neoplasm of breast'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1355.0,0.189719,Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023).,"[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Saadatmand', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Emiel J T', 'Initials': 'EJT', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Ritse M', 'Initials': 'RM', 'LastName': 'Mann', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Diderick B W', 'Initials': 'DBW', 'LastName': 'de Roy van Zuidewijn', 'Affiliation': 'Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Harmien M', 'Initials': 'HM', 'LastName': 'Zonderland', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rob A E M', 'Initials': 'RAEM', 'LastName': 'Tollenaar', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Marc B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Margreet G E M', 'Initials': 'MGEM', 'LastName': 'Ausems', 'Affiliation': 'Department of Genetics, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Martijne', 'Initials': 'M', 'LastName': ""van 't Riet"", 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, Netherlands.'}, {'ForeName': 'Maartje J', 'Initials': 'MJ', 'LastName': 'Hooning', 'Affiliation': 'Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Mares-Engelberts', 'Affiliation': 'Department of Surgery, Vlietland Ziekenhuis, Schiedam, Netherlands.'}, {'ForeName': 'Ernest J T', 'Initials': 'EJT', 'LastName': 'Luiten', 'Affiliation': 'Department of Surgery, Amphia Ziekenhuis, Breda, Netherlands.'}, {'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Karssemeijer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboud University Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Oosterwijk', 'Affiliation': 'Department of Genetics, Groningen University, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Inge-Marie', 'Initials': 'IM', 'LastName': 'Obdeijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Madeleine M A', 'Initials': 'MMA', 'LastName': 'Tilanus-Linthorst', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: madeleinetilanus@hotmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30275-X'] 980,31557056,Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.,"BACKGROUND The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710). CONCLUSIONS An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.",2019,"Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR 1.49, 95% CI 0.98-2.26), ACS treated with PCI (HR 2.02, 95% CI 1.53-2.67) and elective PCI groups (HR 1.91, 95% CI 1.48-2.47) (p interaction =0.479).","['patients with AF who have ACS, whether managed medically or with PCI, or those undergoing', 'Patients with Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or with Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention', 'patients with AF who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor', '4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI', 'three pre-specified subgroups: patients with ACS treated medically, ACS treated with PCI, and those undergoing elective PCI', 'patients with atrial fibrillation (AF) who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI']","['Apixaban', 'apixaban with vitamin K antagonists (VKA) and aspirin with placebo', 'Antithrombotic Therapy', 'elective PCI', 'placebo', 'VKA, apixaban', 'antithrombotic regimens', 'apixaban and a P2Y12 inhibitor without aspirin', 'placebo, aspirin']","['reduced death or hospitalization', 'rate of bleeding', 'elective PCI', 'composite of death or hospitalization', 'ISTH major or CRNM bleeding', 'death and ischemic events', 'safety and efficacy', 'bleeding, death, and hospitalization as well as death and ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4614.0,0.115835,"Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR 1.49, 95% CI 0.98-2.26), ACS treated with PCI (HR 2.02, 95% CI 1.53-2.67) and elective PCI groups (HR 1.91, 95% CI 1.48-2.47) (p interaction =0.479).","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Massaro', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jones-Burton', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heizer', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aschermann', 'Affiliation': 'Charles University, Prague, Czech Republic (M.A.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brieger', 'Affiliation': 'Concord Clinical School, ANZAC Research Institute, University of Sydney, Australia (D.B.).'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cura', 'Affiliation': 'Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena, Argentina (F.C.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospital, University of Copenhagen, Denmark (T.E.).'}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Fridrich', 'Affiliation': 'National Institute of Cardiovascular Diseases, Bratislava, Slovakia (V.F.).'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Oslo University Hospital Ulleval, University of Oslo, Norway (S.H.).'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul National University, Korea (H.-J.K.).'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Leiva-Pons', 'Affiliation': 'Hospital Central Dr Ignacio Morones Prieto, San Luis Potosi, Mexico (J.L.L.-P.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'CONEVID School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'University Hospital Jean Minjoz, Besançon, France (N.M.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.).'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'University of Zagreb School of Medicine, University Hospital Centre, Croatia (D.M.).'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Morais', 'Affiliation': 'Hospital de Santo André, Leiria, Portugal (J.M.).'}, {'ForeName': 'Tatjana S', 'Initials': 'TS', 'LastName': 'Potpara', 'Affiliation': 'School of Medicine, Belgrade University, Serbia (T.S.P.).'}, {'ForeName': 'Dimitar', 'Initials': 'D', 'LastName': 'Raev', 'Affiliation': 'University Hospital St Anna, Sofia, Bulgaria (D.R.).'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.d.W.-T.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck (S.d.W.-T.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College and Research Institute, Bangalore, India (D.X.).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.043308'] 981,31219033,The Postopera tive Quality of Life in Children and Adolescents with Craniopharyngioma.,"BACKGROUND Craniopharyngioma is a tumor of low histological malignancy resulting from an anomaly of embryonic development. Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project. METHODS This prospective, multicenter project consists of a randomized trial with an adaptive design combined with a purely observational study. The randomized, unblinded trial includes patients whose tumors have been incompletely resected and is intended to compare the outcomes of immediate postoperative radiotherapy versus radiotherapy on progression. Its primary endpoint is quality of life as assessed subjectively by the patients them- selves with the ""Pediatric Quality of Life"" questionnaire (PEDQOL). In exploratory analyses, linear mixed models were used to study the effect of further factors on quality of life. RESULTS An interim intention-to-treat analysis of the randomized trial revealed only minor differences between the treatment arms with respect to quality of life (n = 24). The exploratory analyses (n = 131) showed that preoperative involvement of, or operative damage to, the anterior and posterior regions of the hypothalamus was associated with a lower quality of life. Complete resection was followed by a lower quality of life than incomplete resection. Radiotherapy, a common treatment for tumors that progress after incomplete resection, was also associated with a lower quality of life. CONCLUSION Hypothalamus-sparing treatment approaches are recommended to optimize the quality of life of children and adolescents with cranio- pharyngioma. The available evidence does not support any recommendation as to when radiotherapy should be performed after incomplete resection so that the best quality of life can be achieved.",2019,"Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project. ","['Children and Adolescents with Craniopharyngioma', 'children and adolescents with cranio- pharyngioma']","['Radiotherapy', 'radiotherapy versus radiotherapy']","['Postopera tive Quality of Life', 'quality of life, progression-free survival, and overall survival', 'quality of life as assessed subjectively by the patients them- selves with the ""Pediatric Quality of Life"" questionnaire (PEDQOL', 'quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010276', 'cui_str': ""Rathke's Cleft Neoplasm""}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0512248,"Affected children and adolescents are being studied with respect to their quality of life, progression-free survival, and overall survival in the framework of the ongoing KRANIOPHARYNGEOM 2007 project. ","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Eveslage', 'Affiliation': ""Institute of Biostatistics and Clinical Research, Universtity of Münster; Department of Pediatric Hematology/Oncology, University Children's Hospital Bonn; Department of Interventional and Diagnostic Neuroradiology, Universitiy Hospital Würzburg; Department of Radiation Oncology, University of Leipzig; Department of Radiotherapy, University Hospital Regensburg; Department of Particle Therapy, University Hospital Essen, West German Proton Therapy Centre Essen (WPE); Division of Pediatric Neurosurgery within the Department of Neurosurgery, University Hospital Tübingen; Department of Neurosurgery, University Medical Center Hamburg-Eppendorf (UKE); Institute of Biostatistics and Clinical Research, Universtity of Münster; Department of General Pediatrics, Hematology/Oncology, University Children's Hospital Oldenburg.""}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Calaminus', 'Affiliation': ''}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Warmuth-Metz', 'Affiliation': ''}, {'ForeName': 'Rolf-Dieter', 'Initials': 'RD', 'LastName': 'Kortmann', 'Affiliation': ''}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Pohl', 'Affiliation': ''}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Timmermann', 'Affiliation': ''}, {'ForeName': 'Martin Ulrich', 'Initials': 'MU', 'LastName': 'Schuhmann', 'Affiliation': ''}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Flitsch', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Faldum', 'Affiliation': ''}, {'ForeName': 'Hermann Lothar', 'Initials': 'HL', 'LastName': 'Müller', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0321'] 982,31218718,Effective ways to retain first-time blood donors: a field-trial study.,"BACKGROUND Regular blood donors are the cornerstone of blood safety. Understanding the donors' behavior to donate blood improves blood donor retention programs. The purpose of this study is to evaluate the return rate of first-time blood donors following different interventions to identify effective ways to retain first-time donors. STUDY DESIGN AND METHODS The study was conducted on 1356 first-time blood donors at four main blood centers in Iran. The donors were randomly assigned based on different interventions (phone calls, educational letter, emotional letter, incentive, motivational meeting, and no intervention) to six groups. The return rate of donors was defined as a second attempt to donate within 6 months after the first donation. Return rate and 95% confidence intervals (CIs) were calculated and compared among different groups. RESULTS A total of 394 (29%) donors returned within 6 months for a second donation (95% CI, 0.26-0.31). The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively. CONCLUSIONS This study provides evidence supporting the fact that more first-time blood donors can be motivated to donate again by implementing targeted interventions. It demonstrates that emotional letters, educational letters, and phone reminders were effective in improving the return rate of first-time donors.",2019,"The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively. ",['1356 first-time blood donors at four main blood centers in Iran'],"['interventions (phone calls, educational letter, emotional letter, incentive, motivational meeting, and no intervention']","['return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting', 'return rate of donors', 'return rate of first-time donors', 'Return rate and 95% confidence intervals (CIs']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]",1356.0,0.0373074,"The return rate in the emotional letter group, educational letter, phone reminder, incentives, motivational meeting, and control groups was 36% (95% CI, 0.31-0.42), 33.2% (95% CI, 0.27-0.38), 31.5% (95% CI, 0.25-0.37), 30% (95% CI, 0.22-0.38), 22% (95% CI, 0.17-0.27) and 22.1% (95% CI, 0.17-0.27), respectively. ","[{'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Hashemi', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Maghsudlu', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Nasizadeh', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Esmaielifar', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Pourfathollah', 'Affiliation': 'Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran.'}]",Transfusion,['10.1111/trf.15404'] 983,31792949,The effect of a low-dose naloxone infusion on the incidence of respiratory depression after intrathecal morphine administration for major open hepatobiliary surgery: a randomised controlled trial.,"Intrathecal morphine is an analgesic option for major hepatopancreaticobiliary procedures but is associated with a risk of respiratory depression. We hypothesised that a postoperative low-dose naloxone infusion would reduce the incidence of respiratory depression without an increase in pain scores. Patients scheduled for major open hepatopancreaticobiliary surgery and who were receiving 10 μg.kg -1 intrathecal morphine were eligible for inclusion. Patients were allocated randomly to receive a postoperative infusion of naloxone 5 μg.kg -1 .h -1 (naloxone group) or saline at an identical infusion rate (control group) until the morning after surgery. Clinicians, nursing staff and patients were blinded to group allocation. The primary outcome measure was the incidence of respiratory depression (respiratory rate < 10 breaths.min -1 and/or oxygen saturation < 90%). Secondary outcome measures included: arterial partial pressure of carbon dioxide; pain score; requirement for supplemental analgesic; and incidence of nausea and vomiting, pruritus and sedation. In total, data from 95 patients (48 in the naloxone group and 47 in the control group) were analysed. The incidence of respiratory depression was lower in the naloxone group compared with the control group (10/48 vs. 21/47 patients, respectively; p = 0.037, relative risk 0.47 (95%CI 0.25-0.87). Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001). A low-dose naloxone infusion decreases the incidence of respiratory depression following intrathecal morphine administration in patients having major hepatopancreaticobiliary surgery at the expense of a small increase in postoperative pain.",2020,"Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001).","['95 patients (48 in the naloxone group and 47 in the control group) were analysed', 'major open hepatobiliary surgery', 'Patients scheduled for major open hepatopancreaticobiliary surgery and who were receiving 10', 'patients having major hepatopancreaticobiliary surgery']","['Intrathecal morphine', 'intrathecal morphine', 'naloxone infusion', 'naloxone group) or saline', 'naloxone', 'naloxone 5\xa0μg.kg -1 .h -1']","['respiratory depression', 'pain scores', 'postoperative pain', 'arterial partial pressure of carbon dioxide; pain score; requirement for supplemental analgesic; and incidence of nausea and vomiting, pruritus and sedation', 'incidence of respiratory depression', 'Maximum pain scores', 'incidence of respiratory depression (respiratory rate <\xa010 breaths.min -1 and/or oxygen saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.429976,"Maximum pain scores were greater for patients allocated to the naloxone group compared with control (median 5 (95%CI 4-6) vs. 4 (95%CI 2-4), respectively; p < 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cosgrave', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vencken', 'Affiliation': 'Clinical Research Centre, University College Dublin, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Galligan', 'Affiliation': 'Clinical Research Centre, University College Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soukhin', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'McMullan', 'Affiliation': 'Department of Anaesthesia, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Liver transplantation and cardiac anaesthesia, Kings College Hospital NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Puttappa', 'Affiliation': 'Department of Anaesthesia, Addenbrookes Hospital, Cambridge University Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boylan', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': ""Clinical Research Centre, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Conlon', 'Affiliation': ""Department of Anaesthesia, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': ""Department of Intensive Care Medicine, St. Vincent's University Hospital, Dublin, Ireland.""}]",Anaesthesia,['10.1111/anae.14931'] 984,31752762,Efficacy of path-oriented psychological self-help interventions to improve mental health of empty-nest older adults in the Community of China.,"BACKGROUND China has the world's largest aging population and the number of empty-nest older adults is on the rise. In comparison to the aging population in general, empty-nest older adults have a lower level of subjective well-being and poorer mental health status due to a lack of emotional support from their children. The aim of this study is to conduct an empirical study to evaluate the efficacy of the 'Path-oriented Psychological Self-help Intervention' (P-oPSI) led by nurses on the mental health of empty-nest older adults in the community, to provide a scientific foundation for improving their quality of life. METHODS A Quasi-Experimental controlled intervention study was conducted from 2015 to 2017. A total of 76 empty-nest older adults from 2 districts were recruited using a convenience sampling and assigned to 2 groups based on their residential communities in the city of Chifeng in the Inner Mongolia Autonomous Region, China. The wait list control group participated in a mental health lecture to gain knowledge and learn techniques of mental health promotion. The intervention group additionally received 1 month of training in a nurse-led 'P-oPSI' for a month. Both groups were followed-up for 3 months. Mental health status, coping styles, and psychological self-help ability of the participating empty nest older adults were assessed at the baseline, 1 month, and 3-months follow up, respectively. Two-way analysis of variance and a simple effect test were used to analyse the differences of the two groups. RESULTS The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group. Combined with a simple effect test, the scores of the mental health status, positive coping style, and psychological self-help ability of those in the intervention group significantly increased at 1 month after the baseline (F mental health status  = 7.59, F positive coping style  = 7.24, F psychological self-help ability  = 7.07); and the sustainable effect of this program lasted for 3 months after the intervention (F mental health status  = 13.24, F positive coping style  = 10.42, F psychological self-help ability  = 10.45), which reached statistical significance (P < 0.01). CONCLUSIONS The P-oPSI program significantly improved the level of mental health of empty-nest older adults in China. This intervention provides a new approach of self-management to improve mental health of older adults in community settings. TRIAL REGISTRATION chictr.org.cn: ChiCTR1900025552. Retrospectively registered 1 September 2019.",2019,"The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group.","['76 empty-nest older adults from 2 districts were recruited using a convenience sampling and assigned to 2 groups based on their residential communities in the city of Chifeng in the Inner Mongolia Autonomous Region, China', 'older adults in community settings', 'A Quasi-Experimental controlled intervention study was conducted from 2015 to 2017', 'empty-nest older adults', 'empty-nest older adults in the Community of China']","[""Path-oriented Psychological Self-help Intervention' (P-oPSI"", ""1 month of training in a nurse-led 'P-oPSI"", 'mental health lecture to gain knowledge and learn techniques of mental health promotion', 'path-oriented psychological self-help interventions']","['level of mental health', 'scores of the mental health status, positive coping style, and psychological self-help ability', 'Mental health status, coping styles, and psychological self-help ability', 'mental health status, coping styles, and psychological self-help ability', 'mental health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021515', 'cui_str': 'Inner Mongolia'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0373645,"The P-oPSI yielded a greater benefit for the mental health status, coping styles, and psychological self-help ability of the participants in the intervention group.","[{'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, 313000, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL, 32804, USA.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Binzhou Polytechnic, Binzhou, 256600, Shandong, China.'}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Yu', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, 313000, Zhejiang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'School of Nursing, Harbin Medical University, DaQing Campus, Daqing, 163319, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, 433 First Avenue, New York, NY, 10010, USA. bei.wu@nyu.edu.'}]",BMC psychiatry,['10.1186/s12888-019-2327-9'] 985,31208475,Sex differences in postprandial responses to different dairy products on lipoprotein subclasses: a randomised controlled cross-over trial.,"Men have earlier first-time event of CHD and higher postprandial TAG response compared with women. The aim of this exploratory sub-study was to investigate if intake of meals with the same amount of fat from different dairy products affects postprandial lipoprotein subclasses differently in healthy women and men. A total of thirty-three women and fourteen men were recruited to a randomised controlled cross-over study with four dairy meals consisting of butter, cheese, whipped cream or sour cream, corresponding to 45 g of fat (approximately 60 energy percent). Blood samples were taken at 0, 2, 4 and 6 h postprandially. Lipoprotein subclasses were measured using NMR and analysed using a linear mixed model. Sex had a significant impact on the response in M-VLDL (P=0·04), S-LDL (P=0·05), XL-HDL (P=0·009) and L-HDL (P=0·001) particle concentration (P), with women having an overall smaller increase in M-VLDL-P, a larger decrease in S-LDL-P and a larger increase in XL- and L-HDL-P compared with men, independent of meal. Men showed a decrease in XS-VLDL-P compared with women after intake of sour cream (P<0·01). In men only, XS-VLDL-P decreased after intake of sour cream compared with all other meals (v. butter: P=0·001; v. cheese: P=0·04; v. whipped cream: P=0·006). Meals with the same amount of fat from different dairy products induce different postprandial effects on lipoprotein subclass concentrations in men and women.",2019,Men showed a decrease in XS-VLDL-P compared to women after intake of sour cream (P<0.01).,"['healthy women and men', 'men and women', 'Thirty-three women and 14 men']","['Dairy Products', 'dairy meals consisting of butter, cheese, whipped cream or sour cream']","['lipoprotein subclass concentrations', 'Sex Differences', 'postprandial triglyceride response', 'Lipoprotein subclasses', 'XL-HDL', 'L-HDL', 'XL-, and L-HDL-P', 'postprandial lipoprotein subclasses', 'M-VLDL-P', 'XS-VLDL-P', 'response in M-VLDL', 'S-LDL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452750', 'cui_str': 'Whipping cream (substance)'}, {'cui': 'C0452749', 'cui_str': 'Soured cream (substance)'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0445604', 'cui_str': 'Subclass (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036866', 'cui_str': 'Sexual Dimorphism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",,0.0856183,Men showed a decrease in XS-VLDL-P compared to women after intake of sour cream (P<0.01).,"[{'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hansson', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Linn K L', 'Initials': 'LKL', 'LastName': 'Øyri', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Hilde K', 'Initials': 'HK', 'LastName': 'Brekke', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Gyrd O', 'Initials': 'GO', 'LastName': 'Gjevestad', 'Affiliation': 'TINE SA, Centre for Research and Development, P.O. Box 7, Kalbakken, 0902 Oslo, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1122, Blindern, 0317 Oslo, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.'}]",The British journal of nutrition,['10.1017/S0007114519001429'] 986,30715100,Association of Orthostatic Hypotension Timing With Clinical Events in Adults With Diabetes and Hypertension: Results From the ACCORD Trial.,"OBJECTIVE To determine the effects of orthostatic hypotension (OH) measurement timing on its associations with dizziness, falls, fractures, cardiovascular disease (CVD), and mortality. METHODS We analyzed OH measurements from the Action to Control Cardiovascular Risk in Diabetes BP trial, which evaluated two blood pressure (BP) goals (systolic BP [SBP] < 120 mm Hg vs. SBP < 140 mm Hg) and incident CVD among adults with diabetes and hypertension. Seated BP was measured after 5 minutes of rest at baseline and follow-up visits (12 months, 48 months, and exit). Standing BP was measured 3 consecutive times (M1-M3) after standing, starting at 1 minute with each measurement separated by 1 minute. Consensus OH was defined as a drop in SBP ≥ 20 mm Hg or diastolic BP (DBP) ≥ 10 mm Hg. Participants were asked about orthostatic dizziness, recent falls, and recent fractures, and underwent surveillance for CVD events and all-cause mortality. RESULTS There were 4,268 participants with OH assessments over 8,450 visits (mean age 62.6 years [SD = 6.6]; 46.6% female; 22.3% black). Although all measures of consensus OH were significantly associated with dizziness, none were associated with falls, and only M2 (~3 minutes) was significantly associated with fractures. No measurements were associated with CVD events, but later measurements were significantly associated with mortality. BP treatment goal did not increase risk of OH regardless of timing. Associations were not consistently improved by the mean or minimum of M1-M3. CONCLUSION In this population of adults with hypertension and diabetes, neither single time nor set of measurements were clearly superior with regard to outcomes. These findings support the use of a flexibly timed, single measurement to assess OH in clinical practice. CLINICAL TRIALS REGISTRATION Trial Number NCT00000620.",2019,"OH were significantly associated with dizziness, none were associated with falls, and only M2 (~3 minutes) was significantly associated with fractures.","['adults with hypertension and diabetes', 'adults with diabetes and hypertension', 'Adults With Diabetes and Hypertension', '4,268 participants with OH assessments over 8,450 visits (mean age 62.6 years [SD = 6.6]; 46.6% female; 22.3% black']",[],"['blood pressure (BP) goals (systolic BP [SBP', 'dizziness, falls, fractures, cardiovascular disease (CVD), and mortality', 'CVD events', 'Seated BP', 'mortality', 'dizziness', 'Standing BP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",4268.0,0.0640957,"OH were significantly associated with dizziness, none were associated with falls, and only M2 (~3 minutes) was significantly associated with fractures.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Section for Research, Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lewis A', 'Initials': 'LA', 'LastName': 'Lipsitz', 'Affiliation': 'Department of Medicine, Division of Gerontology, Beth Israel Deaconess Medical Center, Marcus Institute for Aging Research, Hebrew Senor Life, & Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beach', 'Affiliation': 'Section for Research, Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Section for Research, Department of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}]",American journal of hypertension,['10.1093/ajh/hpz015'] 987,31206607,Prospective randomized trial comparing two doses of rabbit anti-thymocyte globulin in patients with severe aplastic anaemia.,"The treatment of choice for patients with severe aplastic anaemia (SAA) includes immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG) and ciclosporin A. However, the optimal dose for rabbit ATG has yet to be established. We herein report the first prospective, randomized, multicentre study comparing two doses of rabbit ATG in patients with SAA. Patients with SAA who required initial IST in Japan (n = 89), China (n = 85) and Korea (n = 48) were enrolled between May 2012 and October 2017. A 1:1 block randomization was employed for two doses of rabbit ATG. In total, 222 patients were randomized, with 112 patients receiving 2·5 mg/kg and 110 receiving 3·5 mg/kg of rabbit ATG for 5 days. The primary endpoint was the haematological response at day 180. After 6 months, no significant difference in response rates was observed between the 2·5 and 3·5 mg/kg groups (49% vs. 48%, P = 0·894). Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107]. The current study revealed no significant differences in the efficacy and safety between the 2·5 and 3·5 mg/kg doses of rabbit ATG in patients with SAA. Trial registration: UMIN000011134.",2019,"Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107].","['patients with SAA', '222 patients were randomized, with 112 patients receiving 2·5\xa0mg/kg and 110 receiving 3·5', 'Patients with SAA who required initial IST in Japan (n\xa0=\xa089), China (n\xa0=\xa085) and Korea (n\xa0=\xa048) were enrolled between May 2012 and October 2017', 'patients with severe aplastic anaemia (SAA', 'patients with severe aplastic anaemia']","['rabbit anti-thymocyte globulin', 'rabbit ATG', 'rabbit', 'immunosuppressive therapy (IST) with anti-thymocyte globulin (ATG) and ciclosporin A']","['Overall survival', 'response rates', 'efficacy and safety', 'haematological response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]","[{'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",222.0,0.251333,"Overall survival at 3 years was similar between the two groups [85% (95% confidence interval [CI], 76%-91%) vs. 91% (95% CI, 82%-96%); P = 0·107].","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Narita', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Muramatsu', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Jingliao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Paediatrics, Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, People's Republic of China.""}, {'ForeName': 'Jun H', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Haematology Oncology, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Department of Paediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Hawk', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Haematology, Gachon University Gil Medical Centre, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Usuki', 'Affiliation': 'Department of Haematology, NTT Medical Centre Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Transfusion Medicine, Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nakao', 'Affiliation': 'Department of Haematology and Respirology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Jong', 'Initials': 'J', 'LastName': 'Wook Lee', 'Affiliation': ""Department of Haematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of Paediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/bjh.16055'] 988,31790639,Impact of mHealth technology on adherence to healthy PA after stroke: a randomized study.,"BACKGROUND Physical activity (PA) is a key health behavior in people with stroke including risk reduction of recurrent stroke. Despite the beneficial effects of PA, many community-dwelling stroke survivors are physically inactive. Information and communication technologies are emerging as a possible method to promote adherence to PA. OBJECTIVE The aim of this study is to investigate the effectiveness of a mobile-health (mHealth) App in improving levels of PA. METHODS Forty-one chronic stroke survivors were randomized into an intervention group (IG) n=24 and a control group (CG) n=17. Participants in the IG were engaged in the Multimodal Rehabilitation Program (MMRP) that consisted on supervising adherence to PA through a mHealth app, participating in an 8-week rehabilitation program that included: aerobic, task-oriented, balance and stretching exercises. Participants also performed an ambulation program at home. The CG received a conventional rehabilitation program. Outcome variables were: adherence to PA, (walking and sitting time/day), walking speed (10MWT); walking endurance (6MWT); risk of falling (TUG); ADLs (Barthel); QoL (Eq-5D5L) and participant's satisfaction. RESULTS At the end of the intervention, community ambulation increased more in IG (38.95 min; SD: 20.37) than in the CG (9.47 min; SD: 12.11) (p≤.05). Sitting time was reduced by 2.96 (SD 2.0) hours/day in the IG and by 0.53 (SD 0.24) hours in the CG (p≤.05). CONCLUSIONS The results suggest that mHealth technology provides a novel way to promote adherence to home exercise programs post stroke. However, frequent support and guidance of caregiver is required to ensure the use of mobile devices.",2020,Sitting time was reduced by 2.96 (SD 2.0) hours/day in the IG and by 0.53 (SD 0.24) hours in the CG (p≤.05).,"['n=24 and a control group (CG) n=17', 'healthy PA after stroke', 'people with stroke including risk reduction of recurrent stroke', 'Forty-one chronic stroke survivors']","[' : Physical activity (PA', 'mobile-health (mHealth) App', 'mHealth technology', 'Multimodal Rehabilitation Program (MMRP) that consisted on supervising adherence to PA through a mHealth app, participating in an 8-week rehabilitation program that included: aerobic, task-oriented, balance and stretching exercises', 'conventional rehabilitation program', 'intervention group (IG']","['Sitting time', 'community ambulation', ""adherence to PA, (walking and sitting time/day), walking speed (10MWT); walking endurance (6MWT); risk of falling (TUG); ADLs (Barthel); QoL (Eq-5D5L) and participant's satisfaction""]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439511', 'cui_str': 'times/day (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",41.0,0.0476273,Sitting time was reduced by 2.96 (SD 2.0) hours/day in the IG and by 0.53 (SD 0.24) hours in the CG (p≤.05).,"[{'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Grau-Pellicer', 'Affiliation': 'Rehabilitation Unit, Hospital-Consorci Sanitari de Terrassa , Barcelona, Spain.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lalanza', 'Affiliation': 'Laboratory of Sport Psychology, Autonomous University of Barcelona , Bellaterra, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jovell-Fernández', 'Affiliation': 'Department of Epidemiology, Hospital-Consorci Sanitari de Terrassa , Barcelona, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Capdevila', 'Affiliation': 'Laboratory of Sport Psychology, Autonomous University of Barcelona , Bellaterra, Spain.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1691816'] 989,29940390,Exposure to positive peer sentiment about nicotine replacement therapy in an online smoking cessation community is associated with NRT use.,"BACKGROUND Little is known about the influence of online peer interactions on health behavior change. This study examined the relationship between exposure to peer sentiment about nicotine replacement therapy (NRT) in an online social network for smoking cessation and NRT use. METHODS Participants were 3297 current smokers who enrolled in an Internet smoking cessation program, participated in a randomized trial, and completed a 3-month follow-up. Half received free NRT as part of the trial. Automated text classification identified 27,038 posts about NRT that one or more participants were exposed to in the social network. Sentiment towards NRT was rated on Amazon Mechanical Turk. Participants' exposure to peer sentiment about NRT was determined by analysis of clickstream data. Modified Poisson regression examined self-reported use of NRT at 3-months as a function of exposure to NRT sentiment, controlling for study arm and post exposure. RESULTS One in five participants (19.3%, n = 639) were exposed to any NRT-related posts (mean exposure = 6.5 ± 14.7, mean sentiment = 5.4 ± 0.8). The association between sentiment exposure and NRT use varied by receipt of free NRT. Greater exposure to positive NRT sentiment was associated with an increased likelihood of NRT use among participants who did not receive free NRT (adjusted rate ratio 1.22, 95% CI 1.01, 1.47; p = .043), whereas no such relationship was observed among participants who did receive free NRT (p = .48). CONCLUSIONS Exposure to positive sentiment about NRT was associated with increased NRT use when smokers obtained it on their own. Highlighting user-generated content containing positive NRT sentiment may increase NRT use among treatment-seeking smokers.",2018,"Greater exposure to positive NRT sentiment was associated with an increased likelihood of NRT use among participants who did not receive free NRT (adjusted rate ratio 1.22, 95% CI 1.01, 1.47; p = .043), whereas no such relationship was observed among participants who did receive free NRT (p = .48). ",['Participants were 3297 current smokers who enrolled in an'],"['Internet smoking cessation program', 'nicotine replacement therapy', 'nicotine replacement therapy (NRT']",[],[{'cui': 'C3241966'}],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],639.0,0.0119339,"Greater exposure to positive NRT sentiment was associated with an increased likelihood of NRT use among participants who did not receive free NRT (adjusted rate ratio 1.22, 95% CI 1.01, 1.47; p = .043), whereas no such relationship was observed among participants who did receive free NRT (p = .48). ","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Pearson', 'Affiliation': 'University of Nevada, Reno, NV, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Amato', 'Affiliation': 'Schroeder Institute for Tobacco Research & Policy Studies, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Papandonatos', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, United States.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Tippie College of Business, The University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Erar', 'Affiliation': 'Center for Statistical Sciences, Brown University, Providence, RI, United States.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Information, Central University of Finance and Economics, Beijing, China.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Schroeder Institute for Tobacco Research & Policy Studies, Truth Initiative, Washington, DC, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'Battelle Memorial Institute, Arlington, VA, United States; Department of Oncology, Georgetown University Medical Center/Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Washington, DC, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Schroeder Institute for Tobacco Research & Policy Studies, Truth Initiative, Washington, DC, United States; Department of Oncology, Georgetown University Medical Center/Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Washington, DC, United States. Electronic address: agraham@truthinitiative.org.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.06.022'] 990,31504690,A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children.,"BACKGROUND Hydration effects on cognition remain understudied in children. This is concerning since a large proportion of US children exhibit insufficient hydration. OBJECTIVE This study investigated the effects of water intake on urinary markers of hydration and cognition among preadolescents. METHODS A 3-intervention crossover design was used among 9- to 11-y-olds [n = 75 (43 males, 32 females); 58.2 ± 28.5 BMI percentile]. Participants maintained their water intake [ad libitum (AL)] or consumed high (2.5 L/d) or low (0.5 L/d) water for 4 d. The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively. Secondary outcomes included urine hydration indices [i.e., color, urine specific gravity (USG), osmolality] assessed using 24-h urine collected during day 4 of each intervention. Repeated-measures ANOVAs were used to assess intervention effects. RESULTS There was a significant difference in hydration across all 3 interventions. Urine color during the low intervention [median (IQR): 6 (2)] was greater than during AL [5 (2)], and both were greater than during the high intervention [18 (0)] (all P ≤ 0.01). Similarly, osmolality [low (mean ± SD): 912 ± 199 mOsmol/kg, AL: 790 ± 257.0 mOsmol/kg, high: 260 ± 115 mOsmol/kg] and USG [low (mean ± SD): 1.023 ± 0.005, AL: 1.020 ± 0.007, high: 1.005 ± 0.004] during the low intervention were greater during AL, and both were greater than during the high intervention (all P ≤ 0.01). USG and osmolality AL values were related to switch task measures (β: 0.21 to -0.31, P < 0.05). Benefits of the high intervention were observed during the switch task, whereby participants exhibited 34% lower working memory cost relative to the low intervention. No significant changes in cognition were observed for the flanker and go/no-go tasks. CONCLUSIONS The water intervention improved urinary markers of hydration and had selective benefits during task switching. Furthermore, children's cognitive flexibility selectively benefits from greater habitual hydration and water intake. This study is registered at clinicaltrials.gov as NCT02816450.",2019,"The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively.","['Preadolescent Children', 'children', '75 (43 males, 32 females); 58.2\xa0±\xa028.5 BMI percentile', '9- to 11-y-olds [n\xa0']","['water intake', '4-d Water Intake Intervention', 'water intake [ad libitum (AL)] or consumed high (2.5 L/d) or low (0.5 L/d) water for 4 d']","['performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively', 'urinary markers of hydration', 'USG and osmolality AL values', 'osmolality [low (mean ± SD): 912\xa0±\xa0199 mOsmol/kg, AL', 'cognition', 'Hydration and Cognitive Flexibility', 'Urine color', 'urine hydration indices [i.e., color, urine specific gravity (USG), osmolality] assessed using 24-h urine collected']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0013123', 'cui_str': 'Water Intake'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439353', 'cui_str': 'mosmol/kg'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042037'}, {'cui': 'C0587361', 'cui_str': 'Specific gravity of urine (finding)'}]",,0.0263834,"The primary outcomes were performance on cognitive tasks requiring inhibition, working memory, and cognitive flexibility assessed using a modified flanker, go/no-go, and color-shape switch tasks, respectively.","[{'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Westfall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Alicia R', 'Initials': 'AR', 'LastName': 'Jones', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Macie A', 'Initials': 'MA', 'LastName': 'Sinn', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, IL, USA.'}, {'ForeName': 'Jeanne H', 'Initials': 'JH', 'LastName': 'Bottin', 'Affiliation': 'Health, Hydration, and Nutrition Science Department, Danone Research, Palaiseau, France.'}, {'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Perrier', 'Affiliation': 'Health, Hydration, and Nutrition Science Department, Danone Research, Palaiseau, France.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz206'] 991,31553203,Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial.,"BACKGROUND Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P =0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P =0.04) and fatal bleeding (1% [4/400] vs 0%, P =0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P =0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.",2019,,['Korean Patients'],"['Ticagrelor Versus Clopidogrel', 'Invasive Management']",[],"[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]",[],,0.179473,,"[{'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Osung', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Korea (O.K.).""}, {'ForeName': 'Jae-Sik', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, Korea (J.S.J.).'}, {'ForeName': 'Sung-Cheol', 'Initials': 'SC', 'LastName': 'Yun', 'Affiliation': 'Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (S.C.Y.).'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Korea (S.W.C.).'}, {'ForeName': 'Sang-Gon', 'Initials': 'SG', 'LastName': 'Lee', 'Affiliation': 'Ulsan University Hospital, Ulsan, Korea (S.G.L.).'}, {'ForeName': 'Hyuck-Jun', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, Korea (H.J.Y.).'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Ahn', 'Affiliation': 'Gachon University Gil Hospital, Incheon, Korea (T.A.).'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Dong-A University Medical Center, Busan, Korea (M.H.K.).'}, {'ForeName': 'Deuk Young', 'Initials': 'DY', 'LastName': 'Nah', 'Affiliation': 'Dongguk University Gyeongju Hospital, Gyeongju, Korea (D.Y.N.).'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Inje University Ilsan Paik Hospital, Ilsan, Korea (S.Y.L.).'}, {'ForeName': 'Jei Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Chonbuk National University Hospital, Jeonju, Korea (J.K.C.).'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.041766'] 992,31553222,Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.,"BACKGROUND The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. METHODS Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. RESULTS Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; P int =0.056) compared with the 0- to 3-year time period. CONCLUSIONS In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.",2019,"Rates of TLF, TVMI and ST were increased through 5-year follow-up with BVS compared with EES.",[],"['cobalt chromium everolimus-eluting stents (EES', 'Complete Everolimus-Eluting Bioresorbable Scaffold Resorption', 'Absorb everolimus-eluting bioresorbable vascular scaffold (BVS']","['cumulative 5-year adverse event rates', 'relative hazards of BVS', 'Rates of TLF, TVMI and ST', 'cumulative to 3 years adverse event rates (particularly TVMI and scaffold thrombosis [ST', 'inferior rates of target lesion failure (TLF; cardiac death, target vessel myocardial infarction [TVMI] or ischemia-driven target lesion revascularization']",[],"[{'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.175231,"Rates of TLF, TVMI and ST were increased through 5-year follow-up with BVS compared with EES.","[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.).'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Ellis', 'Affiliation': 'Cleveland Clinic, OH (S.G.E.).'}, {'ForeName': 'D Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.).'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Caputo', 'Affiliation': ""St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.).""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Rizik', 'Affiliation': 'Scottsdale Healthcare, AZ (D.G.R.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Teirstein', 'Affiliation': 'Scripps Clinic, La Jolla, CA (P.S.T.).'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Litt', 'Affiliation': 'Baptist Medical Center, Jacksonville, FL (M.R.L.).'}, {'ForeName': 'Annapoorna', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Mount Sinai Medical Center, New York (A. Kini).'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Kabour', 'Affiliation': ""Mercy St. Vincent's Medical Center, Toledo, OH (A. Kabour).""}, {'ForeName': 'Steven O', 'Initials': 'SO', 'LastName': 'Marx', 'Affiliation': 'New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.).'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.).'}, {'ForeName': 'Siok Hwee', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Divine E', 'Initials': 'DE', 'LastName': 'Ediebah', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042584'] 993,31779683,A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial.,"BACKGROUND Pregnancy and the postpartum period are times of great change for women and their partners, often bringing substantial challenges and stress. Approximately 10%-20% of women suffer from mood disorders such as depression in the perinatal period. There are risks involved in using psychopharmacological interventions to treat perinatal depression. Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders. The aim of this study is to assess the efficacy of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program that includes compassion training for pregnant women in primary care (PC) settings in the Spanish National Health System to decrease perinatal depression. METHODS A multicenter randomized controlled trial (RCT) will be conducted. Participants will be pregnant women (n = 122) and their partners who wish to participate. They will be enrolled and assessed in PC settings and randomly assigned to either: (1) an adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU); or (2) TAU only. The main outcome to be assessed will be depression, evaluated with the Edinburgh Postnatal Depression Scale (EPDS). Secondary outcomes will include self-reported measures of perceived stress, affects, mindfulness, self-compassion, maternal self-efficacy, and use of health and social services. Patients will be assessed at four timepoints: baseline; post-treatment; and at three and six months after childbirth. Intention-to-treat and per-protocol analyses will be carried out using linear regression mixed models. Effect sizes will be estimated using Cohen's d. DISCUSSION Perinatal depression is a significant health problem. An effective and low-cost childbirth education program that incorporates mindfulness and compassion practices may be a beneficial preventive complementary healthcare modality for expectant women and their partners. This study will be the first multicenter RCT in Spanish PC settings using adapted MBCP and compassion practices to reduce symptoms of depression during pregnancy and the postpartum period. TRIAL REGISTRATION ClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.",2019,Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders.,"['pregnant women in primary care (PC) settings in the Spanish National Health System to decrease perinatal depression', 'Participants will be pregnant women (n\u2009=\u2009122) and their partners who wish to participate', 'expectant women and their partners']","['Mindfulness and compassion-based educational programs', 'MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU); or (2) TAU', 'adapted Mindfulness-Based Childbirth and Parenting (MBCP) program', 'compassion training']","['Edinburgh Postnatal Depression Scale (EPDS', 'self-reported measures of perceived stress, affects, mindfulness, self-compassion, maternal self-efficacy, and use of health and social services', 'depression symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.133037,Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders.,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sacristan-Martin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain. olgasacristan@gmail.com.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Santed', 'Affiliation': 'Department of Personality Psychology, National University of Distance Education (UNED), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Aragon Institute for Health Research (Instituto de Investigacion Sanitaria Aragón (IIS Aragon), Miguel Servet Hospital, Psychiatry Service, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Duncan', 'Affiliation': 'Center for Child & Family Well-Being, School of Human Ecology, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bardacke', 'Affiliation': 'Mindful Birthing and Parenting Foundation, Oakland, CA, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Fernandez-Alonso', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Garcia-Sacristan', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Garcia-Sacristan', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barcelo-Soler', 'Affiliation': 'Aragon Institute for Health Research (Instituto de Investigacion Sanitaria Aragón (IIS Aragon), Miguel Servet Hospital, Psychiatry Service, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain.'}]",Trials,['10.1186/s13063-019-3739-z'] 994,31786746,Effectiveness of barbed repositioning pharyngoplasty for the treatment of obstructive sleep apnea (OSA): a prospective randomized trial.,"PURPOSE The aim of our randomized clinical trial is to produce stronger evidence supporting barbed repositioning pharyngoplasty (BRP) as a therapeutic option for the treatment of obstructive sleep apnea (OSA). METHODS The trial was a single-center prospective controlled trial with two parallel arms (group A: BRP; group B: observation) and randomization. Baseline and 6-month polygraphy evaluating the apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS) were performed. To test the differences among groups of Student's t test, the role of each factor (univariate analysis) and their independent effect (multivariate analysis) was explored using logistic regression model as appropriate. Linear regression was also conducted. RESULTS A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group. BRP showed to be more effective than observation. Logistic regression showed that preoperative AHI is related significantly to postoperative AHI within the BRP group. A linear regression showed that higher baseline AHI predicts more significant postoperative absolute AHI reduction. CONCLUSIONS BRP appears to be a promising technique and might be included within the surgical armamentarium of a sleep surgeon. Patients affected by severe OSA may benefit from this surgery with more significant reduction of AHI values.",2020,"A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group.",['obstructive sleep apnea (OSA'],"['barbed repositioning pharyngoplasty (BRP', 'barbed repositioning pharyngoplasty']","['AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values', 'AHI values', 'apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C1609480', 'cui_str': 'Pharyngoplasty'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range (finding)'}]",,0.0221504,"A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Meccariello', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montevecchi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Vito', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Frassineti', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Gobbi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pelucchi', 'Affiliation': 'Unit of Otolaryngology, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giannicola', 'Initials': 'G', 'LastName': 'Iannella', 'Affiliation': 'Unit of Otolaryngology, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Magliulo', 'Affiliation': 'Unit of Otolaryngology, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy. giovanni.cammaroto@hotmail.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01956-7'] 995,31056423,"Lessons Learned and Strategies for Recruitment of Diverse, Low-income Patients into an Integrative Medical Group Visit Clinical Trial.","OBJECTIVE Description of recruitment methods and lessons learned in a randomized controlled trial of underserved patients using an integrative medical group visits intervention. METHODS Comparison of the demographic characteristics of participants screened and consented to the study as well as description of recruitment methods used. OUTCOME MEASURES This paper examines the characteristics of patients who were eligible compared to those who were not, characteristics of patients at the different sites, and patient characteristics over time (by comparing various cohorts) based on our experiences recruiting underserved patients. RESULTS We screened 338 patients, with 205 (60.6%) meeting eligibility criteria and 159 patients randomized and consented. 133 patients were found ineligible, with the most common reasons being low depression scores (n = 20), manic symptoms (n = 20), and psychotic symptoms (n = 19), and alcohol use (n = 15). We found demographic differences in patients recruited by different methods and at different sites- patients referred by provider letter were older than those referred by self-referral or provider referral (mean age/SD vs. mean age/SD, p = 0.0001). For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons. Patients at DH were also more likely to be white (25%) as compared to BMC (18%) and DH (7%), while those at CSHC were more likely to be black (70%) (p = 0.008).",2019,"For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons.","['underserved patients using an integrative medical group visits intervention', '338 patients, with 205 (60.6%) meeting eligibility criteria and 159 patients randomized and consented', 'Comparison of the demographic characteristics of participants screened and consented to the study as well as description of recruitment methods used', 'patients who were eligible compared to those who were not, characteristics of patients at the different sites, and patient characteristics over time (by comparing various cohorts) based on our experiences recruiting underserved patients', '133 patients were found ineligible, with the most common reasons being low depression scores (n\u202f=\u202f20), manic symptoms (n\u202f=\u202f20), and psychotic symptoms (n\u202f=\u202f19), and alcohol use (n\u202f=\u202f15', 'patients recruited by different methods and at different sites- patients referred by provider letter were older than those referred by self-referral or provider referral (mean age/SD vs. mean age/SD, p\u202f=\u202f0.0001']",[],[],"[{'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3266254', 'cui_str': 'Referred by self (finding)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],[],133.0,0.145108,"For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gardiner', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA. Electronic address: paula.gardiner@bmc.org.'}, {'ForeName': 'Anna Sophia', 'Initials': 'AS', 'LastName': 'Lestoquoy', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'N Lily', 'Initials': 'NL', 'LastName': 'Negash', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gergen-Barnett', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Saper', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Penti', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'White', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'University of Massachusetts Medical School, 55 Lake Street North Worcester, MA 01655-0002 USA.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.01.003'] 996,31130429,Stenting for symptomatic vertebral artery stenosis: a preplanned pooled individual patient data analysis.,"BACKGROUND Symptomatic vertebral artery stenosis is associated with a high risk of recurrent stroke, with higher risks for intracranial than for extracranial stenosis. Vertebral artery stenosis can be treated with stenting with good technical results, but whether it results in improved clinical outcome is uncertain. We aimed to compare vertebral stenting with medical treatment for symptomatic vertebral stenosis. METHODS We did a preplanned pooled individual patient data analysis of three completed randomised controlled trials comparing stenting with medical treatment in patients with symptomatic vertebral stenosis. The primary outcome was any fatal or non-fatal stroke. Analyses were performed for vertebral stenosis at any location and separately for extracranial and intracranial stenoses. Data from the intention-to-treat analysis were used for all studies. We estimated hazard ratios (HRs) with 95% CIs using Cox proportional-hazards regression models stratified by trial. FINDINGS Data were from 354 individuals from three trials, including 179 patients from VIST (148 with extracranial stenosis and 31 with intracranial stenosis), 115 patients from VAST (96 with extracranial stenosis and 19 with intracranial stenosis), and 60 patients with intracranial stenosis from SAMMPRIS (no patients had extracranial stenosis). Across all trials, 168 participants (46 with intracranial stenosis and 122 with extracranial stenosis) were randomly assigned to medical treatment and 186 to stenting (64 with intracranial stenosis and 122 with extracranial stenosis). In the stenting group, the frequency of periprocedural stroke or death was higher for intracranial stenosis than for extracranial stenosis (ten (16%) of 64 patients vs one (1%) of 121 patients; p<0·0001). During 1036 person-years of follow-up, the hazard ratio (HR) for any stroke in the stenting group compared with the medical treatment group was 0·81% CI 0·45-1·44; p=0·47). For extracranial stenosis alone the HR was 0·63 (95% CI 0·27-1·46) and for intracranial stenosis alone it was 1·06 (0·46-2·42; p interaction =0·395). INTERPRETATION Stenting for vertebral stenosis has a much higher risk for intracranial, compared with extracranial, stenosis. This pooled analysis did not show evidence of a benefit for stroke prevention for either treatment. There was no evidence of benefit of stenting for intracranial stenosis. Stenting for extracranial stenosis might be beneficial, but further larger trials are required to determine the treatment effect in this subgroup. FUNDING None.",2019,For extracranial stenosis alone the HR was 0·63,"['168 participants (46 with intracranial stenosis and 122 with extracranial stenosis', 'patients with symptomatic vertebral stenosis', 'symptomatic vertebral artery stenosis', '354 individuals from three trials, including 179 patients from VIST (148 with extracranial stenosis and 31 with intracranial stenosis), 115 patients from VAST (96 with extracranial stenosis and 19 with intracranial stenosis), and 60 patients with intracranial stenosis from SAMMPRIS (no patients had extracranial stenosis']","['stenting with medical treatment', 'vertebral stenting with medical treatment']","['frequency of periprocedural stroke or death', 'hazard ratio (HR) for any stroke', 'fatal or non-fatal stroke', 'intracranial stenosis alone']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0265103', 'cui_str': 'Vertebral Artery Stenosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",,0.0851326,For extracranial stenosis alone the HR was 0·63,"[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Markus', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK. Electronic address: hsm32@medschl.cam.ac.uk.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Harshfield', 'Affiliation': 'Stroke Research Group, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Compter', 'Affiliation': 'Department of Neurology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Kuker', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'L Jaap', 'Initials': 'LJ', 'LastName': 'Kappelle', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clifton', 'Affiliation': ""Department of Neuroradiology, St George's Hospital, London, UK.""}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rothwell', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center, Utrecht University, Utrecht, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30149-8'] 997,31177631,M-SAKHI-Mobile health solutions to help community providers promote maternal and infant nutrition and health using a community-based cluster randomized controlled trial in rural India: A study protocol.,"Reduction of childhood stunting is difficult to achieve by interventions that focus only on improving nutrition during infancy. Comprehensive interventions that extend through the continuum of care from pregnancy to infancy are needed. Mobile phones are now successfully being used for behaviour change communication to improve health. We present the methodology of an mHealth intervention ""Mobile Solutions Aiding Knowledge for Health Improvement"" (M-SAKHI) to be delivered by rural community health workers or Accredited Social Health Activists (ASHAs) for rural women, below or up to 20 weeks of pregnancy through delivery until their infant is 12 months of age. This protocol paper describes the cluster randomized controlled trial to evaluate the effectiveness of M-SAKHI. The primary objective of the trial is to reduce the prevalence of stunting (height-for-age < -2 z-score) in children at 18 months of age by 8% in the intervention as compared with control. The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health. A total of 297 ASHAs, five trained counsellors, and 2,501 participants from 244 villages are participating in this study. The outcome data are being collected by 51 field research officers. This study will provide evidence regarding the efficacy of M-SAKHI to reduce stunting in young children in rural India, and if effective, the cost-effectiveness of M-SAKHI.",2019,"The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health.","['young children in rural India', 'children at 18\xa0months of age by 8% in the intervention as compared with control', 'rural community health workers or Accredited Social Health Activists (ASHAs) for rural women, below or up to 20\xa0weeks of pregnancy through delivery until their infant is 12\xa0months of age', 'A total of 297 ASHAs, five trained counsellors, and 2,501 participants from 244 villages are participating in this study']",['M-SAKHI'],"['maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}]",,0.110952,"The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health.","[{'ForeName': 'Archana B', 'Initials': 'AB', 'LastName': 'Patel', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Priyanka N', 'Initials': 'PN', 'LastName': 'Kuhite', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Yamini', 'Initials': 'Y', 'LastName': 'Pusdekar', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Puranik', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Samreen Sadaf', 'Initials': 'SS', 'LastName': 'Khan', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sumithra', 'Initials': 'S', 'LastName': 'Muthayya', 'Affiliation': 'The Sax Institute, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Tracey-Lea', 'Initials': 'TL', 'LastName': 'Laba', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': ""Michelle D'"", 'Initials': 'M', 'LastName': 'Almeida', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}]",Maternal & child nutrition,['10.1111/mcn.12850'] 998,31187863,Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity.,"BACKGROUND Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm. OBJECTIVES The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity. METHODS Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at <35 wk gestation who were 10-16 mo in corrected age were assigned to receive daily oral supplements of DHA and AA (200 mg each, ""DHA + AA"") or corn oil (placebo) for 180 d. Prespecified secondary outcomes included weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage, which were measured at baseline and trial completion. Mixed-effects regression was used to compare the change in outcomes between the DHA + AA and placebo groups, controlling for baseline values. RESULTS Among 377 children included in the analysis (median corrected age = 15.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end. No statistically significant differences between the DHA + AA and placebo groups in growth or adiposity outcomes were observed. For instance, the change in weight-for-age z scores was 0.1 for the DHA + AA group and 0.0 for the placebo group (effect size = 0.01, P = 0.99). However, post-hoc subgroup analyses revealed a statistically significant interaction between treatment group and sex, suggesting somewhat slower linear growth for females assigned to the DHA + AA group compared with the placebo group. CONCLUSIONS Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo. If DHA supplementation is implemented after the first year of life, it can be expected to have no effect on short-term growth or adiposity. This trial is registered with clinicaltrials.gov as NCT02199808.",2019,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","['Toddlers Born Preterm', 'supplementing toddlers born preterm with DHA and', 'children born preterm', 'Children born at <35 wk gestation who were 10-16 mo in corrected age', '377 children included in the analysis (median corrected age\xa0=\xa015.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end', 'April 2012 and March 2017']","['daily oral supplements of DHA and AA (200 mg each, ""DHA\xa0+\xa0AA"") or corn oil (placebo', 'arachidonic acid (AA', 'placebo', 'Docosahexaenoic and Arachidonic Acid Supplementation']","['weight-for-age z scores', 'growth or adiposity outcomes', 'weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage', 'growth or adiposity']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",377.0,0.675973,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","[{'ForeName': 'Taniqua T', 'Initials': 'TT', 'LastName': 'Ingol', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Keith O', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute, and Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Nelin', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Sheppard', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}]",The Journal of nutrition,['10.1093/jn/nxz115'] 999,31787550,Gonadotrophins or clomiphene citrate in couples with unexplained infertility undergoing intrauterine insemination: a cost-effectiveness analysis.,"RESEARCH QUESTION What is the cost-effectiveness of gonadotrophins compared with clomiphene citrate in couples with unexplained subfertility undergoing intrauterine insemination (IUI) with ovarian stimulation under strict cancellation criteria? DESIGN A cost-effectiveness analysis alongside a randomized controlled trial (RCT). Between July 2013 and March 2016, 738 couples were randomized to gonadotrophins (369) or clomiphene citrate (369) in a multicentre RCT in the Netherlands. The direct medical costs of both strategies were compared. Direct medical costs included costs of medication, cycle monitoring, insemination and, if applicable, pregnancy monitoring. Non-parametric bootstrap resampling was used to investigate the effect of uncertainty in estimates. The cost-effectiveness analysis was performed according to intention-to-treat. The incremental cost-effectiveness ratio (ICER) between gonadotrophins and clomiphene citrate for ongoing pregnancy and live birth was assessed. RESULTS The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472). As ongoing pregnancy rates were 31% in women allocated to gonadotrophins and 26% in women allocated to clomiphene citrate (relative risk 1.16, 95% CI 0.93-1.47), the ICER was €21,804 (95% CI €11,628-31,980) per additional ongoing pregnancy with gonadotrophins and €17,044 (95% CI €8998-25,090) per additional live birth with gonadotrophins. CONCLUSIONS Gonadotrophins are more expensive compared with clomiphene citrate in couples with unexplained subfertility undergoing IUI with adherence to strict cancellation criteria, without being significantly more effective.",2020,The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472).,"['couples with unexplained infertility undergoing intrauterine insemination', 'Between July 2013 and March 2016, 738 couples', '€11,628-31,980) per additional ongoing pregnancy with gonadotrophins and €17,044', 'couples with unexplained subfertility undergoing IUI', 'couples with unexplained subfertility undergoing intrauterine insemination (IUI) with ovarian stimulation under strict cancellation criteria']","['Gonadotrophins or clomiphene citrate', 'clomiphene citrate', 'gonadotrophins and clomiphene citrate', 'gonadotrophins']","['pregnancy rates', 'costs of medication, cycle monitoring, insemination and, if applicable, pregnancy monitoring', 'incremental cost-effectiveness ratio (ICER', 'ICER', 'mean costs per couple']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",738.0,0.227139,The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472).,"[{'ForeName': 'Noor A', 'Initials': 'NA', 'LastName': 'Danhof', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Repping', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'van der Ham', 'Affiliation': 'Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Klijn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Ineke C A H', 'Initials': 'ICAH', 'LastName': 'Janssen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, the Netherlands.'}, {'ForeName': 'Janne-Meije', 'Initials': 'JM', 'LastName': 'Rijn-van Weert', 'Affiliation': 'Department of Obstetrics and Gynaecology, NoordWest Groep Alkmaar, Alkmaar, the Netherlands.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Twisk', 'Affiliation': 'Department of Obstetrics and Gynaecology, MC Zuiderzee, Lelystad, the Netherlands.'}, {'ForeName': 'Maaike A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, the Netherlands.'}, {'ForeName': 'Marie-Louise J', 'Initials': 'MJ', 'LastName': 'Pelinck', 'Affiliation': 'Department of Obstetrics and Gynaecology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Denise A M', 'Initials': 'DAM', 'LastName': 'Perquin', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Dominique E S', 'Initials': 'DES', 'LastName': 'Boks', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Hospital, Hoofddorp, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sluijmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, the Netherlands.'}, {'ForeName': 'Ben W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Monash University, Monash Medical Centre, Clayton Victoria, Australia.'}, {'ForeName': 'Fulco', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique H', 'Initials': 'MH', 'LastName': 'Mochtar', 'Affiliation': 'Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands. Electronic address: m.h.mochtar@amc.uva.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.09.004'] 1000,31678837,The impact of plain packaging and health warnings on consumer appeal of cannabis products.,"BACKGROUND Canada implemented 'plain packaging' regulations and rotating health warnings for cannabis products upon legalizing non-medical cannabis in October 2018. Plain packaging and health warnings are effective policy measures for reducing appeal of tobacco products; however, there is little evidence in the cannabis domain. METHODS An experimental task was conducted as part of the online International Cannabis Policy Study. Participants aged 16-65 from Canada (n = 9987) and US states with 'legal' (n = 7376) and 'illegal' (n = 9682) recreational cannabis were randomly assigned to see one of 18 cannabis product images. Outcomes were product appeal (0 = Not at all appealing, 10 = Very appealing) and perceived youth orientation (4 age groups). A 3 (branding: full branding, brand logo only, or plain black packaging) x 2 (health warning labels: present or absent) x 3 (product type: edible gummies, cannabis oil, or pre-rolled joints) factorial design was used. RESULTS Compared to plain packaging or a brand logo, packages with full branding were considered more appealing and more likely to be youth-oriented (p < 0.001). Products with health warnings were considered less appealing than packages without warnings (p < 0.001). Edible gummies were perceived as more appealing and more likely to be youth-oriented than pre-rolled joints and cannabis oil (p < 0.001). Additionally, edible gummies were rated as significantly more appealing by 16-18 and 19-35-year-olds than by older adults (p < 0.02 for all). CONCLUSIONS Comprehensive health warnings and 'plain packaging' regulations may reduce the appeal of cannabis products in a legal market. The results also provide empirical evidence that edible gummies are perceived to appeal to youth.",2019,Products with health warnings were considered less appealing than packages without warnings (p < 0.001).,"[""Participants aged 16-65 from Canada (n\u202f=\u202f9987) and US states with 'legal' (n\u202f=\u202f7376) and 'illegal' (n\u202f=\u202f9682) recreational cannabis""]","['A 3 (branding: full branding, brand logo only, or plain black packaging', 'plain packaging and health warnings']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030176', 'cui_str': 'Packaging'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],,0.0585123,Products with health warnings were considered less appealing than packages without warnings (p < 0.001).,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: samantha.goodman@uwaterloo.ca.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leos-Toro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: cesar.leos-toro@uwaterloo.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, N2L 3G1, Canada. Electronic address: dhammond@uwaterloo.ca.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107633'] 1001,31775535,"Long-term safety, tolerability, and efficacy of magnesium valproate versus sodium valproate in acute seizures.","Objectives: To evaluate the safety, tolerability and efficacy of magnesium valproate and sodium valproate as monotherapies in patients with epilepsy in China. Methods: We recruited patients admitted with seizures over a two-year period. All patients underwent early neurological assessments, electroencephalogram testing, and neuroimaging. The treatments received at baseline and at one year of follow-up were compared. Results: In total, 175 patients were included. The retention rates of the magnesium valproate and sodium valproate treatments were 73.1% and 64.2%, respectively. The main cause of discontinuation was the development of intolerable adverse events. The retention rate and total effective rate in the magnesium valproate group were significantly higher than those in the sodium valproate group (73.1% and 70.2% versus 64.2% and 47.2%, respectively). The safety endpoints included 120 patients (magnesium valproate: n  = 67; sodium valproate: n  = 53). The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%). Conclusions: Magnesium valproate treatment shows favorable safety and tolerability and is associated with markedly improved seizure control. Ideally, future large, prospective, randomized, and double-blind studies are needed to confirm these findings.",2020,The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%).,"['patients with epilepsy in China', 'All patients underwent early neurological assessments, electroencephalogram testing, and neuroimaging', '175 patients were included', '120 patients (magnesium valproate: n\u2009=\u200967', 'n\u2009=\u200953', 'acute seizures', 'patients admitted with seizures over a two-year period']","['magnesium valproate', 'sodium valproate', 'Magnesium valproate', 'magnesium valproate and sodium valproate']","['retention rate and total effective rate', 'intolerable adverse events', 'incidence of adverse events', 'safety, tolerability and efficacy', 'retention rates', 'favorable safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0524735', 'cui_str': 'Magnesium Valproate'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0524735', 'cui_str': 'Magnesium Valproate'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",175.0,0.110474,The incidence of adverse events in the magnesium valproate group was significantly lower than that in the sodium valproate group (30% versus 51%).,"[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Chongqing Key Laboratory of Neurology, Department of Neurology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}]",Current medical research and opinion,['10.1080/03007995.2019.1699520'] 1002,31778265,Brain oscillatory activity as a biomarker of motor recovery in chronic stroke.,"In the present work, we investigated the relationship of oscillatory sensorimotor brain activity to motor recovery. The neurophysiological data of 30 chronic stroke patients with severe upper-limb paralysis are the basis of the observational study presented here. These patients underwent an intervention including movement training based on combined brain-machine interfaces and physiotherapy of several weeks recorded in a double-blinded randomized clinical trial. We analyzed the alpha oscillations over the motor cortex of 22 of these patients employing multilevel linear predictive modeling. We identified a significant correlation between the evolution of the alpha desynchronization during rehabilitative intervention and clinical improvement. Moreover, we observed that the initial alpha desynchronization conditions its modulation during intervention: Patients showing a strong alpha desynchronization at the beginning of the training improved if they increased their alpha desynchronization. Patients showing a small alpha desynchronization at initial training stages improved if they decreased it further on both hemispheres. In all patients, a progressive shift of desynchronization toward the ipsilesional hemisphere correlates significantly with clinical improvement regardless of lesion location. The results indicate that initial alpha desynchronization might be key for stratification of patients undergoing BMI interventions and that its interhemispheric balance plays an important role in motor recovery.",2020,Patients showing a strong alpha desynchronization at the beginning of the training improved if they increased their alpha desynchronization.,"['chronic stroke', '30 chronic stroke patients with severe upper-limb paralysis']",['intervention including movement training based on combined brain-machine interfaces and physiotherapy'],[],"[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3494289', 'cui_str': 'Brain-Machine Interfaces'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",[],30.0,0.0461035,Patients showing a strong alpha desynchronization at the beginning of the training improved if they increased their alpha desynchronization.,"[{'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Ray', 'Affiliation': 'Institute of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Thiago D C', 'Initials': 'TDC', 'LastName': 'Figueiredo', 'Affiliation': 'Institute of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Larraz', 'Affiliation': 'Institute of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Birbaumer', 'Affiliation': 'Institute of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Ramos-Murguialday', 'Affiliation': 'Institute of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Tübingen, Germany.'}]",Human brain mapping,['10.1002/hbm.24876'] 1003,31782377,Reproductive state and choline intake influence enrichment of plasma lysophosphatidylcholine-DHA: a post hoc analysis of a controlled feeding trial.,"The major facilitator superfamily domain 2a protein was identified recently as a lysophosphatidylcholine (LPC) symporter with high affinity for LPC species enriched with DHA (LPC-DHA). To test the hypothesis that reproductive state and choline intake influence plasma LPC-DHA, we performed a post hoc analysis of samples available through 10 weeks of a previously conducted feeding study, which provided two doses of choline (480 and 930 mg/d) to non-pregnant (n 21), third-trimester pregnant (n 26), and lactating (n 24) women; all participants consumed 200 mg of supplemental DHA and 22 % of their daily choline intake as 2H-labelled choline. The effects of reproductive state and choline intake on total LPC-DHA (expressed as a percentage of LPC) and plasma enrichments of labelled LPC and LPC-DHA were assessed using mixed and generalised linear models. Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women. Contrary to total LPC-DHA, patterns of labelled LPC-DHA enrichments were discordant between pregnant and lactating women (P < 0·05), suggestive of unique, reproductive state-specific mechanisms that result in reduced production and/or enhanced clearance of LPC-DHA during pregnancy and lactation. Regardless of the reproductive state, women consuming 930 v. 480 mg choline per d exhibited no change in total LPC-DHA but higher d3-LPC-DHA (P = 0·02), indicating that higher choline intakes favour the production of LPC-DHA from the phosphatidylethanolamine N-methyltransferase pathway of phosphatidylcholine biosynthesis. Our results warrant further investigation into the effect of reproductive state and dietary choline on LPC-DHA dynamics and its contribution to DHA status.",2019,"Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women.",[],"['reproductive state and choline intake', 'choline', 'supplemental DHA and 22\xa0% of their daily choline intake as 2H-labelled choline']","['total LPC-DHA (expressed as a percentage of LPC) and plasma enrichments of labelled LPC and LPC-DHA', 'total LPC-DHA']",[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.065026,"Reproductive state interacted with time (P = 0·001) to influence total LPC-DHA, which significantly increased by week 10 in non-pregnant women, but not in pregnant or lactating women.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Klatt', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Melissa Q', 'Initials': 'MQ', 'LastName': 'McDougall', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Brenna', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Roberson', 'Affiliation': 'Department of Biomedical Sciences, College of Veterinary Medicine, Cornell University, Ithaca, NY 14853, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA.'}]",The British journal of nutrition,['10.1017/S0007114519002009'] 1004,31775668,Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child's health.,"BACKGROUND As early as pregnancy, maternal mental stress impinges on the child's development and health. Thus, this may cause enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child's needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies on mental stress are necessary, beginning prenatally and applying rigorous research methodology, such as randomized controlled trials, to ensure high validity. METHODS A randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child's mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group. The IG receives an individualized psychotherapy starting prenatal and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed as well as the peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation to the extra-uterine environment. All assessments are compared to an additional control group of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to mental health professionals. DISCUSSION The study aims to prevent the transgenerational transfer of psychiatric and somatic disorders from the mother to her child. The effects of the psychotherapy will be stabilized through telemedicine and long-term impacts on the child's and mothers' mental health are enhanced. The combination of psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking are new in content-related and methodological manner. TRIAL REGISTRATION German Clinical Trials Register: DRKS00017065. Registered 02 May 2019. World Health Organization, Universal Trial Number: U1111-1230-9826. Registered 01 April 2019.",2019,"Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed.","['psychiatric and somatic disorders from the mother to her child', ""pregnant women and young mothers and to improve Child's health"", 'Mentally stressed pregnant women']","['psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking', 'telemedicine', 'individualized psychotherapy and telemedicine', 'psychotherapy', 'psychotherapy and telemedicine', 'intervention (IG) and a not intervened control group']","['mental stress', ""maternal mental stress and the child's mental and physical health"", 'maternal sensitivity', 'transfer into daily life, maternal sensitivity and mother-child-bonding', 'synchronicity of cortisol and oxytocin levels']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0042650', 'cui_str': 'Audiovisual Recording'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439579', 'cui_str': 'Synchronicities (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0739938,"Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bischoff', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany. marie.bischoff1@uni-greifswald.de.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Howland', 'Affiliation': 'Department of Neonatology and Paediatric Intensive Care, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Klinger-König', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tomczyk', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Health and Prevention, Institute of Psychology, University Greifswald, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zygmunt', 'Affiliation': 'Clinic and Polyclinic for Obstetrics and Gynecology, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Department of Neonatology and Paediatric Intensive Care, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van den Berg', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bethke', 'Affiliation': 'Department of Health, Nursing and Administration, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Corleis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Günther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Liutkus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Stentzel', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neumann', 'Affiliation': 'Department of Health, Nursing and Administration, University of Applied Sciences Neubrandenburg, Neubrandenburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Penndorf', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ludwig', 'Affiliation': 'Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hammer', 'Affiliation': 'Department of Functional Genomics, Interfaculty Institute for Genetics and Functional Genomics, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Winter', 'Affiliation': 'Integrated Research Biobank, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}]",BMC psychiatry,['10.1186/s12888-019-2279-0'] 1005,31203243,Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial.,"INTRODUCTION SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens. The intervention is complex and requires a process evaluation to understand how implementation, causal mechanisms and context shape outcomes. The specific aims are to assess fidelity and reach of the implementation, understand the contextual aspects of each intervention site, evaluate the mechanisms of impact, and explore perceived effects. METHODS AND ANALYSIS Following the Medical Research Council guidance on complex interventions, a combination of qualitative and quantitative procedures is applied, including observational checklists and attendance registries, standardised scales (ie, Marcus's Self-Efficacy Questionnaire, Physical Activity Self-Regulation Scale and the Lubben Social Network Scale) at baseline, postintervention and follow-up assessments, semistructured questionnaires gathering contextual characteristics, and participant observations of the sessions. Semistructured interviews and focus groups with the participants and trainers are conducted at postintervention and during the follow-up to explore their experiences. Outcomes from the standardised scales are analysed as moderators within the impact evaluation. Descriptive results on context and perceived effects complement results on impact. The qualitative and quantitative findings will help to refine the logic model to finally support the interpretation of the results on the effectiveness of the intervention. ETHICS AND DISSEMINATION The study design was approved by the respective Ethical Committee of Ramon Llull University, Southern Denmark, Northern Ireland and Ulm University. Participation is voluntary, and all participants are asked to sign informed consent before starting the study. A dissemination plan operationalises how to achieve a social impact by reaching academic and non-academic stakeholders. A data management plan describes the specific data sets and regulates its deposition and curation. All publications will be open access. TRIAL REGISTRATION NUMBER NCT02629666; Pre-results.",2019,"SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens.","['community-dwelling older adults from four European countries', 'community-dwelling older citizens', 'Ramon Llull University, Southern Denmark, Northern Ireland and Ulm University']",[],"['physical activity', ""ie, Marcus's Self-Efficacy Questionnaire, Physical Activity Self-Regulation Scale and the Lubben Social Network Scale) at baseline, postintervention and follow-up assessments, semistructured questionnaires gathering contextual characteristics, and participant observations of the sessions""]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0222045'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0558038', 'cui_str': 'Participant observation (regime/therapy)'}]",,0.0504877,"SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Coll-Planas', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing)- UAB, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Blancafort Alias', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing)- UAB, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tully', 'Affiliation': 'Institute of Mental Health Sciences, School of Health Sciences, Ulster University, Newtownabbey, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caserotti', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Center for Active and Healthy Ageing (CAHA), Syddansk Universitet, Odense, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Blackburn', 'Affiliation': 'Institute of Mental Health Sciences, School of Health Sciences, Ulster University, Newtownabbey, UK.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Skjødt', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Center for Active and Healthy Ageing (CAHA), Syddansk Universitet, Odense, Denmark.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wirth', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Universitat Ulm, Ulm, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deidda', 'Affiliation': 'Health Economics and Health Technology Assessment (HEHTA), University of Glasgow Institute of Health and Wellbeing, Glasgow, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment (HEHTA), University of Glasgow Institute of Health and Wellbeing, Glasgow, UK.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Rothenbacher', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Universitat Ulm, Ulm, Germany.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gallardo Rodríguez', 'Affiliation': 'Departamento de Ciencias del Deporte y Acondicionamiento Físico, CEADE, Universidad Católica de la Santísima Concepción, Concepción, Chile.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Jerez-Roig', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sansano-Nadal', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santiago', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Institute of Mental Health Sciences, School of Health Sciences, Ulster University, Newtownabbey, UK.'}, {'ForeName': 'Míriam', 'Initials': 'M', 'LastName': 'Guerra-Balic', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Martín-Borràs', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Sport Initiative et Loisir Bleu Association, Strasbourg, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lefebvre', 'Affiliation': 'Sport Initiative et Loisir Bleu Association, Strasbourg, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Denkinger', 'Affiliation': 'Agaplesion Bethesda Clinic, Geriatric Research Unit Ulm University and Geriatric Center Ulm Alb-Donau, Universitat Ulm, Ulm, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""UKCRC Centre of Excellence for Public Health (NI), Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK.""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Salvà Casanovas', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing)- UAB, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Roqué I Figuls', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing)- UAB, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027073'] 1006,30448083,The Effects of Grounding (Earthing) on Bodyworkers' Pain and Overall Quality of Life: A Randomized Controlled Trial.,"BACKGROUND It is well known that massage therapists routinely develop a number of health problems related to their profession. PURPOSE To determine the effects of grounding on massage therapists' quality of life and pain. Grounding, refers to being in direct body contact with the ground, such as walking barefoot on humid soil or on grass. SETTING The Chopra Center for Well-Being in Carlsbad, California, USA. PARTICIPANTS Sixteen massage therapists (mean age 42.8 years). RESEARCH DESIGN AND INTERVENTION A stepped wedge cluster design was incorporated into a 6-week double-blind Randomized Controlled Trial (RCT) procedure with massage therapists assigned randomly into one of two cohorts. Therapists were not grounded for the first week, were grounded while working on clients and at home while sleeping for the next four weeks, and then ungrounded for the last week. OUTCOME MEASURES Prior to, during, and immediately following the intervention, participants completed standardized questionnaires reporting on pain, physical function, anxiety, depression, fatigue/tiredness, sleep disturbance and number of hours of sleep, number of clients worked on per working day, energy, and emotional and mental stress. RESULTS As a group, therapists experienced significant increases in physical function and energy and significant decreases in fatigue, depressed mood, tiredness and pain while grounded as compared to not being grounded. At one-month following the study, physical function was also increased and depressed mood and fatigue were decreased. CONCLUSIONS We observed consistent beneficial effects of grounding in domains highly relevant to massage therapists, namely pain, physical function, and mood. These findings, combined with prior results from this trial indicating improvements in inflammatory biomarkers, blood viscosity and heart rate variability (HRV), suggest that grounding is beneficial to massage therapists in multiple domains relevant to their occupation, supporting overall health and quality of life.",2019,"We observed consistent beneficial effects of grounding in domains highly relevant to massage therapists, namely pain, physical function, and mood.","['The Chopra Center for Well-Being in Carlsbad, California, USA', 'Sixteen massage therapists (mean age 42.8 years']",['Grounding (Earthing'],"[""Bodyworkers' Pain and Overall Quality of Life"", 'physical function and energy', 'physical function', 'depressed mood and fatigue', 'fatigue, depressed mood, tiredness and pain', 'pain, physical function, anxiety, depression, fatigue/tiredness, sleep disturbance and number of hours of sleep, number of clients worked on per working day, energy, and emotional and mental stress', 'life and pain', 'inflammatory biomarkers, blood viscosity and heart rate variability (HRV']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242744', 'cui_str': 'Earth (Planet)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005848', 'cui_str': 'Blood Viscosity'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",16.0,0.0715639,"We observed consistent beneficial effects of grounding in domains highly relevant to massage therapists, namely pain, physical function, and mood.","[{'ForeName': 'Gaétan', 'Initials': 'G', 'LastName': 'Chevalier', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, P.O. Box 231025, Encinitas, San Diego, La Jolla, CA, 92023, USA. Electronic address: dlbogc@sbcglobal.net.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, P.O. Box 231025, Encinitas, San Diego, La Jolla, CA, 92023, USA; The Chopra Center for Wellbeing, Carlsbad, CA, USA.'}, {'ForeName': 'Lizabeth', 'Initials': 'L', 'LastName': 'Weiss', 'Affiliation': 'The Chopra Center for Wellbeing, Carlsbad, CA, USA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Chopra', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, P.O. Box 231025, Encinitas, San Diego, La Jolla, CA, 92023, USA; The Chopra Center for Wellbeing, Carlsbad, CA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, P.O. Box 231025, Encinitas, San Diego, La Jolla, CA, 92023, USA.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2018.10.001'] 1007,31785390,Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial.,"PURPOSE The purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT). METHODS One hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score. RESULTS MOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116). CONCLUSION In this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint. LEVEL OF EVIDENCE Level Ⅰ, Multicenter Randomized Controlled Trial.",2020,"RESULTS MOCART scores in the investigation group showed improved defect repair and filling (P = 0.0201), integration with the border zone (P = 0.0062) and effusion (P = 0.0079).","['One hundred participants', 'Treating Knee Cartilage Defects', 'patients with a cartilage defect of the knee with microfractures and']","['porcine-derived collagen-augmented chondrogenesis technique (C-ACT', 'Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment', 'C-ACT', 'Microfractures Versus a Porcine derived Collagen-Augmented Chondrogenesis Technique']","['MCID of KOOS pain', 'defect filling and Repaired Tissue/Reference Cartilage (RT/RC) ratio', 'Clinical and magnetic resonance imaging (MRI) outcomes', 'clinical efficacy and safety', 'Magnetic resonance imaging (MRI) outcomes', 'efficacy and adverse events', 'defect repair and filling', 'odds ratio (OR) for ≥ 50% defect filling', 'odds ratio (OR) for the VAS-20% improvement rate', 'visual analogue scale (VAS)-pain, VAS-20% improvement, minimal clinically important difference (MCID), patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0598067', 'cui_str': 'Chondrogenesis'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1265651', 'cui_str': 'Micro Fractures'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",100.0,0.174962,"RESULTS MOCART scores in the investigation group showed improved defect repair and filling (P = 0.0201), integration with the border zone (P = 0.0062) and effusion (P = 0.0079).","[{'ForeName': 'Man Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Churl Hong', 'Initials': 'CH', 'LastName': 'Chun', 'Affiliation': 'Department of Orthopaedic Surgery, Wonkwang University Hospital, College of Medicine, Wonkwang University, Iksan, Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedic Surgery, Samsung Medical Center, College of Medicine, Sungkyunkwan University of School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Goo', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Doo', 'Initials': 'JD', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Ewha Womans University Mokdong Hospital, College of Medicine, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Je-Gyun', 'Initials': 'JG', 'LastName': 'Chon', 'Affiliation': 'Department of Orthopaedic Surgery, Daejeon Sun Hospital, Daejeon, Korea.'}, {'ForeName': 'Myung Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Inha University Hospital, College of Medicine, Inha University, Incheon, Korea.'}, {'ForeName': 'Chan Woong', 'Initials': 'CW', 'LastName': 'Moon', 'Affiliation': ""Department of Orthopaedic Surgery, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Chong Bum', 'Initials': 'CB', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Soo', 'Initials': 'IS', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, Daejeon Sun Hospital, Daejeon, Korea.'}, {'ForeName': 'Jeong Ku', 'Initials': 'JK', 'LastName': 'Ha', 'Affiliation': 'Department of Orthopedic Surgery, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Korea.'}, {'ForeName': 'Nam Yong', 'Initials': 'NY', 'LastName': 'Choi', 'Affiliation': ""Department of Orthopaedic Surgery, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. Electronic address: iy1000@catholic.ac.kr.""}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.11.110'] 1008,31775685,The (cost) effectiveness of guided internet-based self-help CBT for dialysis patients with symptoms of depression: study protocol of a randomised controlled trial.,"BACKGROUND Only a minority of dialysis patients with depressive symptoms are diagnosed and receive treatment. Depressive symptoms are highly prevalent in this population and are associated with adverse clinical outcomes. Underlying factors for this undertreatment may be the lack of evidence for the safety and effectivity of antidepressant medication, the reluctance of patients to adhere to antidepressant medication, the lack of mental healthcare provision in somatic healthcare environments and end-stage renal disease (ESRD) related physical limitations that complicate face-to-face psychotherapy. Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers. The aim of this study is to investigate the (cost) effectiveness of a guided Internet-based self-help intervention for symptoms of depression in dialysis patients. METHODS This study is a cluster randomized controlled trial (RCT) that investigates the effectiveness of a 5-week Internet-based self-help Problem Solving Therapy (PST) for depressive symptoms in dialysis patients. Depressive symptoms will be measured using the Beck Depression Inventory - second edition (BDI-II), with a cut-off score of ≥10. We aim to include 206 dialysis patients with depressive symptoms who will be cluster randomized to the intervention or the Care as Usual (CAU) control group. Secondary outcomes will include anxiety symptoms, quality of life, economic costs and clinical outcomes, such as inflammatory factors and hair cortisol levels. Assessments will take place at baseline (T0), 2 weeks after intervention (T1) and 6 months (T2), 12 months (T3) and 18 months (T4) after intervention. The control group will be measured at the same time points. Analysis will be based on the intention-to-treat principle. Mixed models will be used to assess the changes within each condition between pre-treatment and post-treatment. DISCUSSION If demonstrated to be (cost) effective, Internet-based PST will offer new possibilities to treat dialysis patients with depressive symptoms and to improve their quality of care. TRIAL REGISTRATION Dutch Trial Register: Trial NL6648 (NTR6834) (prospectively registered 13th November 2017).",2019,Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers.,"['depressive symptoms in dialysis patients', 'dialysis patients', '206 dialysis patients with depressive symptoms who will be cluster randomized to the intervention or the', 'dialysis patients with symptoms of depression', 'dialysis patients with depressive symptoms']","['Care as Usual (CAU) control group', '5-week Internet-based self-help Problem Solving Therapy (PST', 'guided internet-based self-help CBT', 'guided Internet-based self-help intervention', 'Guided Internet-based self-help treatment']","['anxiety symptoms, quality of life, economic costs and clinical outcomes, such as inflammatory factors and hair cortisol levels', 'Depressive symptoms']","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",206.0,0.165598,Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers.,"[{'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Nadort', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands. e.nadort@olvg.nl.'}, {'ForeName': 'Robbert W', 'Initials': 'RW', 'LastName': 'Schouten', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}, {'ForeName': 'Friedo W', 'Initials': 'FW', 'LastName': 'Dekker', 'Affiliation': 'Department of Clinical Epidemiology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Honig', 'Affiliation': 'Department of Psychiatry, OLVG, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'van Oppen', 'Affiliation': 'Department of Amsterdam Public Health research institute, VUmc, Van der Boechorststraat 7, 1081 BT, Amsterdam, Netherlands.'}, {'ForeName': 'Carl E H', 'Initials': 'CEH', 'LastName': 'Siegert', 'Affiliation': 'Department of Nephrology, OLVG hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands.'}]",BMC psychiatry,['10.1186/s12888-019-2363-5'] 1009,31200629,Dynamic scapular recognition exercise improves scapular upward rotation and shoulder pain and disability in patients with adhesive capsulitis: a randomized controlled trial.,"Background : Examine the ability of a dynamic scapular recognition exercise to improve scapular upward rotation and decrease shoulder pain and disability in patients with adhesive capsulitis of the shoulder. Methods : A test-retest randomized controlled study design was used. A total of sixty-six patients with unilateral adhesive capsulitis were equally divided into two groups. The study group received a dynamic scapular recognition exercise using a wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb. A digital inclinometer was used to measure the scapular upward rotation and ROM of the shoulder joint, and the Shoulder Pain and Disability Index (SPADI) was used to measure the shoulder pain and disability. Results : Study results showed that after two weeks, there were statistically significant differences between the study and control groups in scapular upward rotation and shoulder flexion and abduction (P < .05) and nonsignificant differences in shoulder external rotation and SPADI (P > .05). After two and six months, there were statistically significant differences between study and control groups in scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores (P < .05). Conclusion : This study showed that a dynamic scapular recognition exercise significantly improves scapular upward rotation and the ROM of shoulder flexion and abduction after two weeks. At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores. These improvements persisted for six months after the performance of this exercise.",2019,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","['A total of sixty-six patients with unilateral adhesive capsulitis', 'patients with adhesive capsulitis', 'patients with adhesive capsulitis of the shoulder']","['Dynamic scapular recognition exercise', 'dynamic scapular recognition exercise', 'dynamic scapular recognition exercise using\xa0a\xa0wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb']","['shoulder pain and disability', 'scapular upward rotation and shoulder flexion and abduction', 'shoulder external rotation and SPADI', 'scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores', 'scapular upward rotation and ROM of the shoulder joint,\xa0and the Shoulder Pain and Disability Index (SPADI', 'scapular upward rotation and the ROM of shoulder flexion and abduction', 'scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores', 'scapular upward rotation and shoulder pain and disability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise (regime/therapy)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",66.0,0.0736383,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'a Rehabilitation Engineering Lab, Department of Kinesiology and Community Health , University of Illinois at Urbana-Champaign , Champaign , IL , USA.'}, {'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'a Rehabilitation Engineering Lab, Department of Kinesiology and Community Health , University of Illinois at Urbana-Champaign , Champaign , IL , USA.'}, {'ForeName': 'Wadida H', 'Initials': 'WH', 'LastName': 'El Sayed', 'Affiliation': 'c Department of Basic Science, Faculty of Physical Therapy , Cairo University , Giza Egypt.'}, {'ForeName': 'Mohamed E Abd', 'Initials': 'MEA', 'LastName': 'El Wanis', 'Affiliation': 'd Department of Orthopedic, Faculty of Medicine , Suhag University , Sohag , Egypt.'}, {'ForeName': 'Abeer A', 'Initials': 'AA', 'LastName': 'Yamany', 'Affiliation': 'c Department of Basic Science, Faculty of Physical Therapy , Cairo University , Giza Egypt.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1622896'] 1010,31201426,The Impact of Learning Multiple Real-World Skills on Cognitive Abilities and Functional Independence in Healthy Older Adults.,"OBJECTIVE The natural learning experience from infancy to emerging adulthood, when considerable cognitive and functional growth is observed, mandates learning multiple real-world skills simultaneously. The present studies investigated whether learning multiple real-world skills simultaneously is possible in older adults and also whether it improves both their cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence. METHOD Over two studies (15 and 27 participants), older adults learned at least three new skills (e.g., Spanish, drawing, music composition) simultaneously for 3 months. Participants completed cognitive and functional assessments before, during, and after the intervention in both studies. Participants were recruited sequentially for an intervention or no-contact control group in Study 1, and Study 2 included only an intervention group, who also completed assessments 4-6 weeks prior to the start of the intervention (i.e., they served as their own control group). RESULTS Results from both studies show that simultaneously learning multiple skills is feasible and potentially beneficial for healthy older adults. Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults, 30 years younger. DISCUSSION Our findings demonstrate the feasibility and potential of conducting a real-world skill-learning intervention involving learning three novel skills with older adults. Our multiskill intervention may provide broad cognitive gains, akin to the benefits experienced earlier in the life span.",2020,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults. ","['healthy older adults', 'middle-aged adults', 'older adults']","['intervention or no-contact control', 'learning multiple real-world skills', 'real-world skill learning intervention']","['cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence', 'cognitive abilities', 'cognitive abilities and functional independence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",3.0,0.0257695,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults. ","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Leanos', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Kürüm', 'Affiliation': 'Department of Statistics, University of California, Riverside.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Strickland-Hughes', 'Affiliation': 'Department of Psychology, University of the Pacific, Sacramento, California.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Ditta', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Gianhu', 'Initials': 'G', 'LastName': 'Nguyen', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Felix', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Hara', 'Initials': 'H', 'LastName': 'Yum', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Bloomberg School of Public Health and Johns Hopkins Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz084'] 1011,31564057,Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials.,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13. International phase II and III studies have evaluated the efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis (AD), but the effects of dupilumab in Japanese patients have not been reported. OBJECTIVES To evaluate the efficacy and safety of dupilumab in Japanese patients with moderate-to-severe AD. METHODS We analysed the efficacy and safety of dupilumab in the Japanese cohorts of a 16-week, phase IIb dose-finding trial (AD-1021; NCT01859988); a 16-week, phase III, placebo-controlled monotherapy trial (LIBERTY AD SOLO 1; NCT02277743) and a 52-week, phase III, placebo-controlled study of dupilumab with topical corticosteroids (LIBERTY AD CHRONOS; NCT02260986). RESULTS Twenty-seven, 106 and 117 Japanese patients were enrolled in AD-1021, SOLO 1 and CHRONOS, respectively. Baseline disease severity was numerically higher in the Japanese cohort than in the overall study population. Generally, dupilumab significantly improved signs and symptoms of AD, including pruritus and patient quality of life, compared with placebo in the Japanese cohort, consistent with the overall study population. The combined safety profile of dupilumab in the Japanese cohort was similar to that in the total study populations; dupilumab was associated with an increased incidence of injection-site reactions and conjunctivitis compared with placebo. Dupilumab was associated with rapid reduction in thymus and activation-regulated chemokine and gradual IgE reductions. CONCLUSIONS Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD, had an acceptable safety profile, and suppressed biomarkers of type 2 inflammation compared with placebo in Japanese adult patients with moderate-to-severe AD. What's already known about this topic? Differences in atopic dermatitis (AD) pathology have been reported between Asian and Western populations, in which distinct helper T-cell activation profiles have been observed. International clinical studies in adults with moderate-to-severe AD have evaluated the efficacy and safety of dupilumab, which blocks interleukin-4 and interleukin-13, key molecules in type 2 inflammation. The effects of dupilumab in Japanese patients specifically have not yet been reported. What does this study add? Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD and had an acceptable safety profile compared with placebo in Japanese patients with moderate-to-severe AD. The effects were comparable with those observed in the overall study population. Reported immunological differences in AD pathology in Asian patients may be secondary to type 2 immune activation.",2019,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","['Japanese adults with moderate-to-severe atopic dermatitis', 'Twenty-seven, 106, and 117 Japanese patients enrolled in AD-1021, SOLO 1 and CHRONOS, respectively', 'adults with moderate-to-severe atopic dermatitis (AD', 'Japanese adult patients with moderate-to-severe AD', 'Japanese patients with moderate-to-severe AD']","['placebo-controlled monotherapy', 'dupilumab with topical corticosteroids (TCS, LIBERTY AD', 'placebo', 'Dupilumab alone or with TCS', 'dupilumab']","['Baseline disease severity', 'efficacy and safety', 'signs and symptoms of AD, including pruritus, and patient quality of life', 'Efficacy and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}]",117.0,0.0559352,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Dermatology, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': 'Department of Dermatology, Tokyo Teishin Postal Services Agency Hospital, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Department of Dermatology, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Department of Dermatology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Department of Dermatology, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18565'] 1012,31782966,A randomized clinical trial of mobile phone motivational interviewing for alcohol use problems in Kenya.,"AIM To test the effectiveness of a motivational interviewing (MI) intervention using the mobile phone among adults with alcohol use problems. DESIGN A randomized clinical trial of mobile MI and standard in-person MI with 1- and 6-month follow-up, including a 1-month waitlist control followed by mobile MI. SETTING A primary health center in rural Kenya. PARTICIPANTS Three hundred adults screening positive for alcohol use problems were randomized and received immediate mobile MI (n = 89), in-person MI (n = 65) or delayed mobile MI (n = 76) for waiting-list controls 1 month after no treatment, with 70 unable to be reached for intervention. INTERVENTION AND COMPARATOR One MI session was provided either immediately by mobile phone, in-person at the health center or delayed by 1 month and then provided by mobile phone. MEASUREMENTS Alcohol use problems were repeatedly assessed using the Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT-C. The primary outcome was difference in alcohol score 1 month after no intervention for waiting-list control versus 1 month after MI for mobile MI. The secondary outcomes were difference in alcohol score for in-person MI versus mobile MI one and 6 months after MI. FINDINGS For our primary outcome, average AUDIT-C scores were nearly three points higher (difference = 2.88, 95% confidence interval = 2.11, 3.66) for waiting-list controls after 1 month of no intervention versus mobile MI 1 month after intervention. Results for secondary outcomes supported the null hypothesis of no difference between in-person and mobile MI at 1 month (Bayes factor = 0.22), but were inconclusive at 6 months (Bayes factor = 0.41). CONCLUSION Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya. Providing mobile motivational interviewing may help clinicians in rural areas to reach patients needing treatment for alcohol use problems.",2020,"CONCLUSION Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya.","['adults visiting primary care in Kenya', 'Three hundred adults screening positive for alcohol use problems', 'A primary health center in rural Kenya', 'adults with alcohol use problems', 'Alcohol Use Problems in Kenya']","['Mobile Phone Motivational Interviewing', 'mobile motivational interviewing', 'mobile MI and standard in-person MI with 1- and 6-month follow-up, including a one-month waitlist control followed by mobile MI', 'Mobile phone-based motivational interviewing', 'motivational interviewing (MI) intervention', 'immediate mobile MI (n=89), in-person MI (n=65), or delayed mobile MI']","['null hypothesis of no difference between in-person and mobile MI', 'alcohol score for in-person MI vs. mobile MI one and six months after MI', 'alcohol score', 'average AUDIT-C scores', 'Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT-C']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",300.0,0.0830683,"CONCLUSION Mobile phone-based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya.","[{'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Harder', 'Affiliation': 'Departments of Pediatrics and Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Abednego M', 'Initials': 'AM', 'LastName': 'Musau', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Christine W', 'Initials': 'CW', 'LastName': 'Musyimi', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Ndetei', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}, {'ForeName': 'Victoria N', 'Initials': 'VN', 'LastName': 'Mutiso', 'Affiliation': 'Africa Mental Health Foundation, Nairobi, Kenya.'}]","Addiction (Abingdon, England)",['10.1111/add.14903'] 1013,31773765,"Impact on sexual function of plasma button transurethral vapour enucleation versus plasmakinetic resection of the large prostate >90 ml: Results of a prospective, randomized trial.","To compare the impact of plasma button transurethral vapour enucleation of the prostate (PVEP) and plasmakinetic resection of the prostate (PKRP) on lower urinary tract symptoms and sexual function in patients with benign prostatic enlargement (BPE) >90 ml. Between July 2017 and August 2018, 101 patients with symptomatic BPE were randomly, prospectively assigned to either PKRP or PVEP in our department. The clinical characteristics and sexual function were evaluated before and after surgery. Post-void residual volume, IPSS and QoL were all significantly decreased compared with baseline data in each group, while Qmax was significantly increased. The IIEF-5 score showed a slight but nonsignificant increase in both groups at 3 and 6 months after surgery, and there was no significant difference between the two groups. The post-operative rate of reduced ejaculate volume was significantly higher than the pre-operative rate in PKRP group, while there was no significant difference in PVEP group. PVEP had an attenuated effect on no ejaculate compared with PRKP, and they both had a significantly negative effect on no ejaculate. PVEP is an effective and minimally invasive procedure for large prostate. Compared with PKRP, PVEP has no effect on erectile dysfunction and has a lower negative impact on ejaculation.",2020,"The IIEF-5 score showed a slight but nonsignificant increase in both groups at 3 and 6 months after surgery, and there was no significant difference between the two groups.","['patients with benign prostatic enlargement ', 'large prostate >90', 'Between July 2017 and August 2018, 101 patients with symptomatic BPE']","['plasma button transurethral vapour enucleation of the prostate (PVEP) and plasmakinetic resection of the prostate (PKRP', 'PKRP or PVEP', 'PKRP, PVEP', 'PVEP', 'plasma button transurethral vapour enucleation versus plasmakinetic resection']","['erectile dysfunction', 'IIEF-5 score', 'post-operative rate of reduced ejaculate volume', 'Post-void residual volume, IPSS and QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0426732', 'cui_str': 'Large prostate (finding)'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0597635', 'cui_str': 'Vapor (substance)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0427992', 'cui_str': 'Semen volume measurement'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}]",101.0,0.0189896,"The IIEF-5 score showed a slight but nonsignificant increase in both groups at 3 and 6 months after surgery, and there was no significant difference between the two groups.","[{'ForeName': 'Zhenqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Dingqi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, Shandong Zaozhuang Municipal Hospital, Zaozhuang, Shandong, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Keqin', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong, China.'}]",Andrologia,['10.1111/and.13390'] 1014,31687769,Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.,"INTRODUCTION Smoking is a key determinant of mortality among people living with HIV (PLWH). METHODS To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH. RESULTS Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01). CONCLUSIONS HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences. IMPLICATIONS PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking. TRIAL REGISTRATION (1) Using ""warm handoffs"" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.",2020,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","['Hospitalized Smokers (HelpingHAND2', 'people living with HIV (PLWH', '5550 hospitalized smokers', 'hospitalized smokers with tobacco treatment after discharge', 'hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART', 'HIV-Infected Smokers', 'participants without HIV following a hospital-initiated smoking cessation intervention', 'urban hospital patients', 'cigarette smokers']","['usual care or a smoking cessation intervention', 'Post-Discharge Strategies', 'PLWH', 'smoking-cessation interventions', 'Smoking Cessation Interventions']","['Abstinence rates', 'smoking cessation', 'self-reported past 30-day tobacco abstinence', 'cessation rates', 'quit rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",,0.0487106,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Triant', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Somerville, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas, Nashville, TN.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Division of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Harrington', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz168'] 1015,31779684,Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination.,"BACKGROUND The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.",2019,The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients.,['nursing home patients'],['suite of videos to improve advance care planning (ACP'],[],"[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]",[],,0.0909736,The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients.,"[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA. japalmer5@gmail.com.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Parker', 'Affiliation': 'Peter T. Paul College of Business and Economics, University of New Hampshire, 10 Garrison Avenue, Durham, NH, 03824, USA.'}, {'ForeName': 'Lacey R', 'Initials': 'LR', 'LastName': 'Barre', 'Affiliation': 'Department of Health Services, Policy, and Practice, School of Public Health, Brown University, 121 S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy, and Practice, School of Public Health, Brown University, 121 S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Belanger', 'Affiliation': 'Department of Health Services, Policy, and Practice, School of Public Health, Brown University, 121 S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Health Services, Policy, and Practice, School of Public Health, Brown University, 121 S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, School of Public Health, Brown University, 121 S Main St, Providence, RI, 02903, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.'}]",Trials,['10.1186/s13063-019-3725-5'] 1016,31769845,Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease.,"BACKGROUND Mycophenolate has been shown to be effective in glomerular disease. However, the role of mycophenolate in the first-line treatment of adult-onset idiopathic minimal change disease (MCD) has not been systematically studied in a randomized fashion. AIM To evaluate the therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for MCNS. DESIGN A prospective, open-label, randomized clinical trial. METHODS Twenty adult patients with biopsy proven MCD were recruited and randomly assigned to receive either enteric-coated Mycophenolate Sodium (EC-MPS) plus low-dose prednisolone (Group 1: Prednisolone 0.25 mg/kg/day, n = 10) or standard-dose prednisolone (Group 2: Prednisolone 1 mg/kg/day, n = 10). RESULTS After 24 weeks of therapy, eight patients in Group 1 vs. seven of patients in Group 2 achieved complete remission (P = 0.606). Both groups showed a significant reduction of urine protein excretion (P < 0.05) and increased serum albumin (P < 0.001) vs. baseline levels. However, no significant between-group differences were demonstrated. The relapse rate was also similar in both groups. Both treatment regimens were well tolerated but there were more patient reported adverse effects in the standard-dose prednisolone group. CONCLUSION EC-MPS plus low-dose prednisolone is non-inferior to standard-dose prednisolone therapy in inducing clinical remission and preventing relapse in adult-onset idiopathic MCD and is associated with better tolerability and less adverse effects. This trial is registered with the ClinicalTrials.gov number NCT01185197.",2020,Both groups showed a significant reduction of urine protein excretion (p < 0.05) and increased serum albumin (p < 0.001) vs baseline levels.,"['20 adult patients with biopsy proven MCD', 'adult onset idiopathic minimal change disease (MCD']","['prednisolone', 'Prednisolone', 'EC-MPS plus low dose prednisolone', 'Mycophenolate', 'corticosteroid and mycophenolate', 'mycophenolate', 'recevie either enteric coated Mycophenolate Sodium (EC-MPS) plus low dose prednisolone', 'Prednisolone 0.25\u2009mg/kg/day, n\u2009=\u200910) or standard dose prednisolone']","['urine protein excretion', 'relapse rate', 'serum albumin', 'adverse effects', 'complete remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1636149', 'cui_str': 'Mcd'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1337395', 'cui_str': 'mycophenolate sodium'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",20.0,0.134735,Both groups showed a significant reduction of urine protein excretion (p < 0.05) and increased serum albumin (p < 0.001) vs baseline levels.,"[{'ForeName': 'M K M', 'Initials': 'MKM', 'LastName': 'Ma', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'D Y H', 'Initials': 'DYH', 'LastName': 'Yap', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Li', 'Affiliation': 'Renal Department, Centro Hospitalar Conde de São Januário, Macao, China.'}, {'ForeName': 'M M Y', 'Initials': 'MMY', 'LastName': 'Mok', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'G C W', 'Initials': 'GCW', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'L P Y', 'Initials': 'LPY', 'LastName': 'Kwan', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Lai', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'S C W', 'Initials': 'SCW', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.'}]",QJM : monthly journal of the Association of Physicians,['10.1093/qjmed/hcz297'] 1017,31779693,A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial.,"BACKGROUND During hospitalization, older adults (+ 65 years) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response in muscle mass and strength. However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge, on the effect on change in mobility in older medical patients. METHODS Older medical patients (≥ 65 years) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-h mobility, lower extremity strength, gait speed, grip strength and activities of daily living. RESULTS Eighty-five patients were randomized to an intervention group (N = 43) or a control group (N = 42). In the intervention group, 43% were highly compliant with the intervention. Our intention-to-treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks, - 4.17 (95% CI - 11.09; 2.74; p = 0.24) nor in any of the secondary outcomes. The per-protocol analysis showed that the daily number of steps taken increased significantly more in the intervention group compared to the control group (mean difference in change from baseline to 4 weeks, 1033.4 steps (95% CI 4.1; 2062.7), p = 0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI 3.6; 2061.9), p = 0.049, adjusted for mobility at baseline, length of stay, and steps at baseline). CONCLUSIONS Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care in the effect on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a greater daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. TRIAL REGISTRATION ClinicalTrials.gov, NCT01964482. Registered on 14 October 2013. Trial protocol PubMed ID (PMID), 27039381.",2019,"The per-protocol analysis showed that the daily number of steps taken increased significantly more in the intervention group compared to the control group (mean difference in change from baseline to 4 weeks, 1033.4 steps (95% CI 4.1; 2062.7), p = 0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI 3.6; 2061.9), p = 0.049, adjusted for mobility at baseline, length of stay, and steps at baseline). ","['Eighty-five patients', 'older medical patients', '65\u2009years) admitted acutely from their home to the Emergency Department', 'older adults (+\u200965 years', 'Older medical patients (≥']","['strength training', 'supervised progressive cross-continuum strength training and protein supplementation', 'supervised strength training program', 'Systematic strength training', 'standard care or supervised progressive strength training and an oral protein supplement']","['daily number of steps', 'mobility', 'change in mobility', 'daily number of steps, high compliance', 'De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking', 'daily number of steps taken', '24-h mobility, lower extremity strength, gait speed, grip strength and activities of daily living']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",85.0,0.183914,"The per-protocol analysis showed that the daily number of steps taken increased significantly more in the intervention group compared to the control group (mean difference in change from baseline to 4 weeks, 1033.4 steps (95% CI 4.1; 2062.7), p = 0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI 3.6; 2061.9), p = 0.049, adjusted for mobility at baseline, length of stay, and steps at baseline). ","[{'ForeName': 'Mette Merete', 'Initials': 'MM', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark. mette.merete.pedersen@regionh.dk.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Department of Physical and Occupational Therapy, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Bispebjerg Bakke 23, 2400, Copenhagen N, Denmark.'}, {'ForeName': 'Helle Gybel-Juul', 'Initials': 'HG', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Pia Søe', 'Initials': 'PS', 'LastName': 'Jensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3720-x'] 1018,30345574,Improving empathy with motivational strategies in batterer intervention programmes: Results of a randomized controlled trial.,"OBJECTIVES Empathy (i.e., the ability to decode emotions, as well as cognitive and emotional empathy) is involved in moral reasoning, prosocial behaviour, social and emotional adequacy, mood and behaviour regulation. Hence, alterations in these functions could reduce behaviour control and the adoption of specific types of violence such as intimate partner violence (IPV). Although interventions for IPV perpetrators focus on reducing IPV risk factors and increasing protective factors to prevent this kind of violence, the study of the effectiveness of these programmes in promoting changes in empathy (cognitive and emotional) has been neglected. DESIGN Hence, the main aim of this study was to compare the effectiveness of two different modalities of IPV intervention programmes (Standard Batterer Intervention Programs [SBIP] vs. SBIP + Individualized Motivational Plan [IMP]) in promoting empathic improvements after both interventions. METHOD Participants were randomly assigned to receive SBIP (n = 40) or SBIP + IMP (n = 53). The effectiveness of the intervention in the total sample and the group effects were evaluated with general linear model repeated-measures ANOVA. RESULTS Results revealed that only the IPV perpetrators who received the SBIP + IMP were more accurate in decoding emotional facial signals and presented better cognitive empathy (perspective taking) after the intervention programme. CONCLUSIONS Our study reinforces the view that different modalities of IPV intervention might lead to different cognitive outcomes after the intervention. Thus, these results may help professionals to develop specific intervention programmes focused on improving cognitive abilities in order to reduce IPV recidivism. PRACTITIONER POINTS Interventions for batterers' neglected empathic changes after these programmes. Not enough randomized controlled trials for these kinds of interventions. An improvement in the ability to decode emotions after the intervention programme. An improvement in cognitive empathy (perspective taking) after the intervention programme. Different modalities of IPV intervention might lead to different cognitive outcomes after the intervention.",2019,"RESULTS Results revealed that only the IPV perpetrators who received the SBIP + IMP were more accurate in decoding emotional facial signals and presented better cognitive empathy (perspective taking) after the intervention programme. ","['Participants', 'batterer intervention programmes']","['SBIP\xa0+\xa0IMP', 'SBIP', 'IPV intervention', 'IPV intervention programmes (Standard Batterer Intervention Programs [SBIP] vs. SBIP\xa0+\xa0Individualized Motivational Plan [IMP']","['cognitive empathy (perspective taking', 'IPV risk factors', 'decoding emotional facial signals']",[],"[{'cui': 'C0021533', 'cui_str': 'Ribosylhypoxanthine Monophosphate'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0415897,"RESULTS Results revealed that only the IPV perpetrators who received the SBIP + IMP were more accurate in decoding emotional facial signals and presented better cognitive empathy (perspective taking) after the intervention programme. ","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Romero-Martínez', 'Affiliation': 'Department of Psychobiology, University of Valencia, Spain.'}, {'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Lila', 'Affiliation': 'Department of Social Psychology, University of Valencia, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gracia', 'Affiliation': 'Department of Social Psychology, University of Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moya-Albiol', 'Affiliation': 'Department of Psychobiology, University of Valencia, Spain.'}]",The British journal of clinical psychology,['10.1111/bjc.12204'] 1019,31779696,ENACT: a protocol for a randomised placebo-controlled trial investigating the efficacy and mechanisms of action of adjunctive N-acetylcysteine for first-episode psychosis.,"BACKGROUND First-episode psychosis (FEP) may lead to a progressive, potentially disabling and lifelong chronic illness; however, evidence suggests that the illness course can be improved if appropriate treatments are given at the early stages. Nonetheless, the efficacy of antipsychotic medications is suboptimal, particularly for negative and cognitive symptoms, and more efficacious and benign treatments are needed. Previous studies have shown that the antioxidant amino acid N-acetylcysteine (NAC) reduces negative symptoms and improves functioning in chronic schizophrenia and bipolar disorder. Research is scarce as to whether NAC is beneficial earlier in the course of illness. The primary aim of this study is to determine the efficacy of treatment with adjunctive NAC (2 g/day for 26 weeks) compared with placebo to improve psychiatric symptoms in young people experiencing FEP. Secondary aims are to explore the neurobiological mechanisms underpinning NAC and how they relate to various clinical and functional outcomes at 26- and 52-week follow-ups. METHODS/DESIGN ENACT is a 26-week, randomised controlled trial of adjunctive NAC versus placebo, with a 26-week non-treatment follow-up period, for FEP. We will be recruiting 162 young people aged 15-25 years who have recently presented to, and are being treated at, the Early Psychosis Prevention and Intervention Centre, Melbourne, Australia. The primary outcome is the Total Score on the Positive and Negative Syndrome Scale which will be administered at baseline, and weeks 4, 8, 12, 26 (primary endpoint), and 52 (end of study). Secondary outcomes include: symptomatology, functioning, quality of life, neurocognition, blood-derived measures of: inflammation, oxidative and nitrosative stress, and magnetic resonance spectroscopy measures of glutathione concentration. DISCUSSION Targeted drug development for FEP to date has generally not involved the exploration of neuroprotective agents. This study has the potential to offer a new, safe, and efficacious treatment for people with FEP, leading to better treatment outcomes. Additionally, the neuroprotective dimension of this study may lead to a better long-term prognosis for people with FEP. It has the potential to uncover a novel treatment that targets the neurobiological mechanisms of FEP and, if successful, will be a major advance for psychiatry. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ID: ACTRN12618000413224. Registered on 21 March 2018.",2019,Previous studies have shown that the antioxidant amino acid N-acetylcysteine (NAC) reduces negative symptoms and improves functioning in chronic schizophrenia and bipolar disorder.,"['162 young people aged 15-25\u2009years who have recently presented to, and are being treated at, the Early Psychosis Prevention and Intervention Centre, Melbourne, Australia', 'people with FEP', 'young people experiencing FEP']","['adjunctive N-acetylcysteine', 'antioxidant amino acid N-acetylcysteine (NAC', 'NAC', 'placebo', 'adjunctive NAC', 'ENACT']","['psychiatric symptoms', 'Total Score on the Positive and Negative Syndrome Scale', ' symptomatology, functioning, quality of life, neurocognition, blood-derived measures of: inflammation, oxidative and nitrosative stress, and magnetic resonance spectroscopy measures of glutathione concentration']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0005768'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4505047', 'cui_str': 'Nitrosative Stress'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",162.0,0.174009,Previous studies have shown that the antioxidant amino acid N-acetylcysteine (NAC) reduces negative symptoms and improves functioning in chronic schizophrenia and bipolar disorder.,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia. sue.cotton@orygen.org.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Bartholomeusz', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Bortolasci', 'Affiliation': 'Centre for Molecular and Medical Research, School of Medicine, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Walder', 'Affiliation': 'Centre for Molecular and Medical Research, School of Medicine, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': ""O'Donoghue"", 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'Institute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, School of Medicine, Geelong, VIC, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chanen', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Amminger', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Burnside', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Uren', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ratheesh', 'Affiliation': 'Orygen the National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Locked Bag 10 (35 Poplar Road), Parkville, VIC, 3052, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Institute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, School of Medicine, Geelong, VIC, Australia.'}]",Trials,['10.1186/s13063-019-3786-5'] 1020,29635491,"Erratum for Velmurugan et al. Dietary nitrate improves vascular function in patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr 2016;103:25-38.",,2018,,['patients with hypercholesterolemia'],"['Dietary nitrate', 'placebo']",['vascular function'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.376316,,[],The American journal of clinical nutrition,['10.1093/ajcn/nqx052'] 1021,31597460,Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial.,"BACKGROUND Numerous scales exist for the classification of major bleeding events. Limited data compare the most commonly used bleeding scales within a single at-risk cohort of patients with atrial fibrillation. Here, we analyze bleeding outcomes according to the ISTH (International Society on Thrombosis and Hemostasis), TIMI (Thrombolysis in Myocardial Infarction), GUSTO (Global Usage of Strategies to Open Occluded Arteries), and BARC (Bleeding Academic Research Consortium) bleeding scales in the ENGAGE AF (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation)-TIMI 48 trial (NCT00781391) of edoxaban versus warfarin. METHODS A total of 21 105 patients with atrial fibrillation at risk for stroke (CHADS 2 score ≥2) were enrolled in the ENGAGE AF-TIMI 48 trial comparing warfarin with a higher- (60/30 mg daily) or lower- (30/15 mg daily) dose edoxaban regimen. Median follow-up was 2.8 years. Bleeding events occurring among on-treatment patients were examined. Annualized event rates were calculated by the ISTH, TIMI, GUSTO, and BARC scales and compared across treatment arms. Cox proportional hazards for a first bleeding event of each type were calculated for higher-dose edoxaban regimen vs warfarin and lower-dose edoxaban regimen versus warfarin. RESULTS A total of 10 311 bleeding events were reported. In a comparison of the most severe events in each scale, ISTH major bleeding was the most common (n=1289), followed by TIMI major (n=548), GUSTO severe/life-threatening (n=347), and BARC 3c+5 (n=276) bleeding. Lower bleeding risk with edoxaban compared with warfarin was seen regardless of bleeding scale (higher-dose edoxaban regimen range: hazard ratio [HR], 0.47 [95% CI, 0.35-0.62] for BARC 3c+5 versus HR, 0.80 [95% CI, 0.71-0.91] for ISTH major; lower-dose edoxaban regimen range: HR, 0.32 [95% CI, 0.23-0.45] for BARC 3c+5 versus HR, 0.47 [95% CI, 0.41-0.55] for ISTH major). Furthermore, a gradient of more pronounced risk reduction with edoxaban was observed with greater severity of first bleeding event (higher-dose edoxaban regimen: HR, 0.47 [95% CI, 0.35-0.62] for BARC 3c+5 bleeds versus HR, 0.86 [95% CI, 0.81-0.91] for any BARC bleed; lower-dose edoxaban regimen: HR, 0.32 [95% CI, 0.23-0.45] for BARC 3c+5 bleeds versus HR, 0.68 [95% CI, 0.63-0.72] for any BARC bleed). The direction of this trend was consistent for both gastrointestinal bleeding and nongastrointestinal bleeding. CONCLUSIONS Among patients with atrial fibrillation at risk for stroke, there was a >4-fold difference in the frequency of the most severe bleeding events across commonly used bleeding scales. Furthermore, the relative safety of edoxaban compared with warfarin tended to increase with greater severity of bleeding. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00781391.",2019,Cox proportional hazards for a first bleeding event of each type were calculated for HDER vs warfarin and LDER vs warfarin. ,"['21,105 patients with AF at risk for stroke (CHADS 2 ≥2', 'patients with atrial fibrillation (AF']","['edoxaban vs warfarin', 'edoxaban', 'warfarin']","['severity of bleeding', 'ISTH, TIMI, GUSTO, and BARC bleeding scales', 'bleeding scale', 'Annualized event rates', 'ISTH, TIMI, GUSTO, and BARC scales', 'bleeding risk', 'total bleeding events', 'Bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0222045'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0970187,Cox proportional hazards for a first bleeding event of each type were calculated for HDER vs warfarin and LDER vs warfarin. ,"[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Kamphuisen', 'Affiliation': 'Department of Internal Medicine, Tergooi Hospital, Hilversum, the Netherlands (P.W.K.).'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Daiichi Sankyo Pharma Development, Edison, NJ (M.F.M.).'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany (H.J.L.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., S.D.W., C.T.R., E.M.A., F.N., J.F.K., E.B., R.P.C.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.041346'] 1022,31199210,"Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials.","OBJECTIVES This study aimed to evaluate the risk of suicidal ideation and behavior associated with vortioxetine treatment in adults with major depressive disorder (MDD). METHODS Suicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized, placebo-controlled studies (6-8 weeks) and another long-term pool that included 3 open-label extension studies (52 weeks). Evaluation of suicide-related events was performed using Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data. RESULTS At baseline, the percentage of patients reporting any C-SSRS ideation or behavior events in short-term studies was similar between placebo (14.7%), vortioxetine (19.8%, 13.0%, 11.2%, and 13.7% for 5-, 10-, 15-, and 20-mg groups, respectively), and duloxetine active reference (13.2%) and did not change throughout the 6- to 8-week treatment period for placebo (17.0%), vortioxetine (19.3%, 13.5%, 12.6%, and 15% for 5-, 10-, 15-, and 20-mg groups, respectively), or duloxetine (11.3%). The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine. After 52-week treatment with vortioxetine, suicidal ideation based on C-SSRS was 9.8%, C-SSRS suicidal behavior was 0.2%, and the incidence of suicide-related events based on TEAEs was <1%. There were no completed suicides in any study. CONCLUSIONS Vortioxetine is not associated with increased risk of suicidal ideation or behavior in MDD patients.",2020,"The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine.","['adults with major depressive disorder treated with', 'Suicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized', 'MDD patients', 'adults with major depressive disorder (MDD']","['Vortioxetine', 'placebo', 'placebo-controlled studies (6-8 weeks) and another long-term pool that included 3 open-label extension studies', 'vortioxetine', 'duloxetine']","['Suicidal ideation and behavior', 'suicidal ideation based on C-SSRS', 'percentage of patients reporting any C-SSRS ideation or behavior events', 'Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data', 'incidence of suicide-related events for TEAEs', 'C-SSRS suicidal behavior', 'risk of suicidal ideation or behavior']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.134701,"The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine.","[{'ForeName': 'Atul R', 'Initials': 'AR', 'LastName': 'Mahableshwarkar', 'Affiliation': 'Clinical Development, BlackThorn Therapeutics, San Francisco, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Affinito', 'Affiliation': 'Global Patient Safety Evaluation Marketed Products Group, Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, Illinois, USA.'}, {'ForeName': 'Elin Heldbo', 'Initials': 'EH', 'LastName': 'Reines', 'Affiliation': 'Medical Affairs, H. Lundbeck A/S, Ottiliavej 9, 2500Valby, Denmark.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Biostatistics, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nomikos', 'Affiliation': 'Clinical Research & Development, Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Jacobsen', 'Affiliation': 'Neuroscience, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.'}]",CNS spectrums,['10.1017/S109285291900097X'] 1023,31196813,Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial.,"BACKGROUND Antibiotic-resistant gonorrhoea represents a global public health threat, and new therapies are needed. We aimed to compare the efficacy and safety of solithromycin, a fourth generation macrolide, with ceftriaxone plus azithromycin for the treatment of gonorrhoea. METHODS We did an open-label, multicentre, non-inferiority trial of patients aged 15 years or older with uncomplicated untreated genital gonorrhoea at two sites in Australia and one site in the USA. Patients were randomly assigned (1:1) to receive single dose oral solithromycin 1000 mg or intramuscular ceftriaxone 500 mg plus oral azithromycin 1000 mg. Neisseria gonorrhoeae cultures were obtained at baseline and test of cure (day 7 ± 2). The primary outcome was the proportion of patients with eradication of genital N gonorrhoeae based on culture at test of cure, assessed in the microbiological intention-to-treat (mITT) population, which included all randomly assigned patients who received any dose of study drug and had a positive genital culture for N gonorrhoeae at baseline. Non-inferiority of solithromycin was to be concluded if the lower limit of the 95% CI for the between-group differences was greater than -10%. Safety was analysed in all patients who received any dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02210325. FINDINGS Between Sept 3, 2014, and Aug 27, 2015, 262 patients were randomly assigned and 261 received treatment (130 in the solithromycin group and 131 in the ceftriaxone plus azithromycin group). In the mITT population, 99 (80%) of 123 patients in the solithromycin group and 109 (84%) of 129 patients in the ceftriaxone plus azithromycin group had N gonorrhoeae eradication at test of cure (difference -4·0%, 95% CI -13·6 to 5·5), thus solithromycin did not meet the criterion for non-inferiority at the prespecified -10% margin. The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients). INTERPRETATION Solithromycin as a single 1000 mg dose is not a suitable alternative to ceftriaxone plus azithromycin as first-line treatment for gonorrhoea. If insufficient duration of solithromycin exposure at the infection site in a subset of individuals was the reason for treatment failures, this might be adequately addressed with dose adjustment. However, any further trials with longer dosing need to consider the potential risk of gastrointestinal effects and liver enzyme elevations. FUNDING Cempra Pharmaceuticals.",2019,"The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients). ","['Between Sept 3, 2014, and Aug 27, 2015, 262 patients were randomly assigned and 261 received treatment (130 in the solithromycin group and 131 in the', 'uncomplicated genital gonorrhoea (SOLITAIRE-U', 'patients aged 15 years or older with uncomplicated untreated genital gonorrhoea at two sites in Australia and one site in the USA']","['solithromycin', 'solithromycin 1000 mg or intramuscular ceftriaxone 500 mg plus oral azithromycin', 'Solithromycin versus ceftriaxone plus azithromycin', 'ceftriaxone plus azithromycin']","['Neisseria gonorrhoeae cultures', 'diarrhoea', 'N gonorrhoeae eradication', 'frequency of adverse events', 'proportion of patients with eradication of genital N gonorrhoeae based on culture at test of cure, assessed in the microbiological intention-to-treat (mITT) population', 'efficacy and safety', 'nausea', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C3655918', 'cui_str': '(3AR,4R,7S,9R,10R,11R,13R,15R,15AR)-1-(4-(4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-trideoxy-(dimethylamino)-'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0326603', 'cui_str': 'Solitaire (organism)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3655918', 'cui_str': '(3AR,4R,7S,9R,10R,11R,13R,15R,15AR)-1-(4-(4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl)butyl)-4-ethyl-7-fluoro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-trideoxy-(dimethylamino)-'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C1294230', 'cui_str': 'Neisseria gonorrhoeae culture (procedure)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",262.0,0.381666,"The frequency of adverse events was higher in the solithromycin group than the ceftriaxone plus azithromycin group (69 [53%] of 130 patients vs 45 [34%] of 131 patients), the most common of which were diarrhoea (31 [24%] of 130 patients vs 20 [15%] of 131 patients), and nausea (27 [21%] of 130 patients vs 15 [11%] of 131 patients). ","[{'ForeName': 'Marcus Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: mchen@mshc.org.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McNulty', 'Affiliation': 'Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Avery', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA; School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Whiley', 'Affiliation': ""Queensland Children's Medical Research Institute, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Sepehr N', 'Initials': 'SN', 'LastName': 'Tabrizi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Dwight', 'Initials': 'D', 'LastName': 'Hardy', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stat, Guerneville, CA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nenninger', 'Affiliation': 'Cempra Pharmaceuticals, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Hocking', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW, Australia; Kirby Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oldach', 'Affiliation': 'Cempra Pharmaceuticals, Chapel Hill, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30116-1'] 1024,31189497,Basic life support training: Demonstration versus lecture - A randomised controlled trial.,"INTRODUCTION Basic life support (BLS) and the use of an automated external defibrillator (AED) improve survival from cardiac arrest. The gold standard for teaching BLS/AED is yet to be identified. The aim of this study was to compare the learning outcome of an instructor-led demonstration with a formal lecture for introducing BLS/AED skills. We hypothesized that a demonstration was superior to a lecture. METHODS First year-medical students were randomised to either a demonstration or a lecture using PowerPoint® Presentation for skill introduction during European Resuscitation Council BLS/AED courses. Participants were skill-tested after training and required to perform all skills correctly to pass the test. Finally, all participants were asked to state their preferred teaching method. RESULTS Overall, 247 participants were included in the analysis (demonstration group: 124, lecture group: 123). Pass rate was 63% in both groups, p = 1.00. Both groups performed median compression rates within guidelines recommendations, p = 0.09. Mean compression depth was 55 mm (10 mm) in the demonstration group compared with 52 mm (10 mm) in the lecture group, p = 0.05. Median tidal volume was 265 (192, 447) ml and 405 (262, 578) ml, p < 0.001, respectively. The lecture group was 3 s faster at initiating BLS, p < 0.001. In total, 226 (91%) participants preferred demonstration on a manikin for introducing BLS/AED. CONCLUSION There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED. The lecture group was slightly faster at initiating BLS. Most participants preferred a demonstration as introduction.",2020,There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED.,"['First year-medical students', '247 participants were included in the analysis (demonstration group: 124, lecture group: 123']","['automated external defibrillator (AED', 'demonstration or a lecture using PowerPoint® Presentation']","['Pass rate', 'Median tidal volume', 'Mean compression depth', 'pass rate', 'median compression rates']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",247.0,0.0774313,There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Stinne Eika', 'Initials': 'SE', 'LastName': 'Rasmussen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Mette Amalie', 'Initials': 'MA', 'LastName': 'Nebsbjerg', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Kasper G', 'Initials': 'KG', 'LastName': 'Lauridsen', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bjørnshave Bomholt', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Krogh', 'Affiliation': 'Department of Anesthesia and Intensive Care, Aarhus University Hospital, Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark; Centre for Health Sciences Education, Aarhus University, Palle Juul-Jensens Blvd. 82, INCUBA Skejby building B, 8200 Aarhus, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Løfgren', 'Affiliation': 'Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus, Denmark; Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Clinical Research Unit, Randers Regional Hospital, Skovlyvej 15, 8930 Randers, Denmark; Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Blvd. 82, INCUBA Skejby building 2, 8200 Aarhus, Denmark; Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 69, 8200 Aarhus, Denmark. Electronic address: bo.loefgren@clin.au.dk.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.06.008'] 1025,31199555,Parent Psychological Distress: A Moderator of Behavioral Health Intervention Outcomes among Justice-Involved Adolescents.,"We examined whether pre-existing parent psychological distress moderated juvenile offenders' substance use, sexual risk, and mental health outcomes in a randomized trial. Forty-seven parent-adolescent dyads received either Family-based Affect Management Intervention (FAMI) for adolescent substance use and HIV prevention or adolescent-only Health Promotion Intervention (HPI). Parents' self-reported distress at baseline significantly moderated adolescents' self-reported marijuana use and alcohol use but not other outcomes at 3 months postintervention, producing crossover interactions. FAMI outperformed HPI when parents reported high-level distress, whereas HPI outperformed FAMI when parents reported low-level distress. This finding that the relative efficacy of interventions depends on the severity of parent psychological distress could inform efforts to match substance-using, justice-involved adolescents with the intervention most likely to benefit them.",2020,"Parents' self-reported distress at baseline significantly moderated adolescents' self-reported marijuana use and alcohol use but not other outcomes at 3 months postintervention, producing crossover interactions.","['Justice-Involved Adolescents', 'Forty-seven parent-adolescent dyads']",['Family-based Affect Management Intervention (FAMI) for adolescent substance use and HIV prevention or adolescent-only Health Promotion Intervention (HPI'],[],"[{'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]",[],47.0,0.0221786,"Parents' self-reported distress at baseline significantly moderated adolescents' self-reported marijuana use and alcohol use but not other outcomes at 3 months postintervention, producing crossover interactions.","[{'ForeName': 'Mei Yi', 'Initials': 'MY', 'LastName': 'Ng', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tolou-Shams', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Galbraith', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Alpert Medical School of Brown University.'}]",Journal of research on adolescence : the official journal of the Society for Research on Adolescence,['10.1111/jora.12512'] 1026,31184938,CNR1 and FAAH variation and affective states induced by marijuana smoking.,"Background : Polymorphisms in cannabinoid receptor type 1 (encoded by CNR1 ) and fatty acid amide hydrolase (encoded by FAAH ) have been associated with cannabis dependence, but it remains unknown whether variation within these genes influences cannabis' acute effects on affect. Objective : Conduct a secondary data analysis study to determine whether previously observed acute effects of tetrahydrocannabinol (THC) on mood was dependent upon variation in CNR1 and FAAH . Methods : A balanced placebo design was used crossing marijuana administration (i.e., 0% THC vs. 2.8% THC) with stimulus expectancy. Participants (N = 118; 64% male) provided DNA and completed the Profile of Mood States questionnaire prior to and after smoking. Haplotypes were constructed from genotyped single nucleotide polymorphisms for CNR1 (rs1049353 and rs806368) and FAAH (rs4141964, rs324420, and rs11576941); rs2023239 ( CNR1 ) and rs6703669 ( FAAH ) were not part of a phased haplotype block. Analyses tested both main and interaction effects for genotype across CNR1 and FAAH , and drug, and expectancy effects. Results : THC increased levels of POMS Tension-Anxiety and Confusion-Bewilderment over and above the effects of variation in CNR1 and FAAH . Significant drug X genotype/haplotype and expectancy X genotype/haplotype interaction effects were observed for some but not all mood states [e.g., 'C' allele carriers of rs2023239 who received THC had higher levels of Anger-Hostility ( β = 0.29 (0.12), p = .02) compared to those who received placebo]. Conclusion : These preliminary findings suggest individual differences in mood states after using marijuana depend on genetic variation. Such information might be useful in understanding either motivation for use of marijuana and/or risk for associated behaviors.",2019,"Significant drug X genotype/haplotype and expectancy X genotype/haplotype interaction effects were observed for some but not all mood states [e.g., 'C' allele carriers of rs2023239 who received THC had higher levels of Anger-Hostility ( β = 0.29 (0.12), p = .02) compared to those who received placebo]. ",['Participants (N = 118; 64% male) provided DNA and completed the Profile of Mood States questionnaire prior to and after smoking'],"['tetrahydrocannabinol (THC', 'THC', 'placebo']","['Significant drug X genotype/haplotype and expectancy X genotype/haplotype interaction effects', 'levels of Anger-Hostility', 'CNR1 and FAAH variation and affective states', 'POMS Tension-Anxiety and Confusion-Bewilderment']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0020039', 'cui_str': 'Hostility'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0813178', 'cui_str': 'Bewilderment'}]",,0.172903,"Significant drug X genotype/haplotype and expectancy X genotype/haplotype interaction effects were observed for some but not all mood states [e.g., 'C' allele carriers of rs2023239 who received THC had higher levels of Anger-Hostility ( β = 0.29 (0.12), p = .02) compared to those who received placebo]. ","[{'ForeName': 'Rohan H C', 'Initials': 'RHC', 'LastName': 'Palmer', 'Affiliation': 'a Department of Psychology at Emory University, Behavioral Genetics of Addiction Laboratory , Atlanta , GA , USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'McGeary', 'Affiliation': 'b Providence Veterans Affairs Medical Center , Providence , RI , USA.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Knopik', 'Affiliation': 'e Human Development and Family Studies, Purdue University , West Lafayette , IN , USA.'}, {'ForeName': 'L Cinnamon', 'Initials': 'LC', 'LastName': 'Bidwell', 'Affiliation': 'f Institute for Cognitive Science, University of Colorado at Boulder , Boulder , CO , USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Metrik', 'Affiliation': 'b Providence Veterans Affairs Medical Center , Providence , RI , USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1614596'] 1027,31760109,Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial.,"Opioid prescription in the treatment of chronic pain is frequent and carries a risk of increased morbidity and mortality in a clinically significant number of patients, particularly those who are using opioids in a hazardous manner. Few treatment options are available that target both pain-related interference and hazardous opioid use among patients with chronic pain. In military Veterans, this issue is of particular importance as numerous reports indicate continued high rates of opioid prescription for chronic pain, as well as significant opioid-related problems. The overall aim of the present study was to determine the feasibility of an integrated psychosocial treatment in Veterans with chronic pain, who also have evidence of hazardous opioid use. To examine this aim, a random design was used to assess the feasibility and initial efficacy of integrating 2 empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for opioid misuse. Half of participants were randomized to the integrated treatment group and all participants received usual care through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse. In total, 37 participants were randomized and included in intent-to-treat analyses and 32 individuals were included in per protocol analyses with 6-month follow-up serving as the primary study endpoint. Feasibility indicators included recruitment, retention, and treatment completion rates. Recruitment fell short of targeted enrollment, although retention and completion were excellent. Primary outcome measures were opioid misuse, pain interference, and pain behavior. Simultaneous multiple regression analyses controlled for pain duration, baseline opioid dose, and baseline value for outcome measures. Results of both the intent-to-treat and per protocol indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior. Results support the feasibility of providing an integrated treatment for both opioid risk and pain interference. PERSPECTIVE: Opioid misuse occurs in some opioid-prescribed individuals with chronic pain. Few treatment options exist that target both pain interference and opioid misuse. This study examined feasibility and initial efficacy of an integrated behavioral treatment for Veterans. Feasibility was supported, except recruitment. Efficacy was supported compared to usual care.",2019,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","['military Veterans', 'Veterans with co-morbid chronic pain and hazardous opioid use', 'Veterans', '37 participants were randomized and included in intent to treat (ITT) analyses and 32 individuals were included in per protocol (PP) analyses with 6-month follow-up serving as the primary study endpoint', 'individuals with chronic pain', 'patients with chronic pain', 'Veterans with chronic pain, who also have evidence of hazardous opioid use']","['Opioid prescription', 'integrated behavioral treatment', 'integrated psychosocial treatment', 'Integrated behavioral treatment', ""usual care (UC) through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse""]","['opioid misuse, pain interference, and pain behavior', 'recruitment, retention, and treatment completion rates', 'Efficacy', 'feasibility and initial efficacy']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041735', 'cui_str': 'United States. Dept. of Veterans Affairs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0338037', 'cui_str': ""Private physicians' group office (environment)""}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",37.0,0.0734594,"Results of both the ITT and PP indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior.","[{'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vowles', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Cusack', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Wesley P', 'Initials': 'WP', 'LastName': 'Gilliam', 'Affiliation': 'Pain Rehabilitation Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Cardon', 'Affiliation': ""Raymond G. Murphy Veteran's Affairs Medical Center, New Mexico VA Healthcare System, Albuquerque, New Mexico.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Department of Psychology, Pacific University, Forest Grove, Oregon.'}, {'ForeName': 'Karlyn A', 'Initials': 'KA', 'LastName': 'Edwards', 'Affiliation': ""School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}, {'ForeName': 'Mindy L', 'Initials': 'ML', 'LastName': 'McEntee', 'Affiliation': 'College of Health Solutions, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Bailey', 'Affiliation': 'Swedish Pain Services, Swedish Health System, Seattle, Washington.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.007'] 1028,31760819,Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.,"BACKGROUND Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. METHODS Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. RESULTS Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%; P =0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. CONCLUSIONS The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.",2019,The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF.,"['patients with AF and advanced HF', 'patients with HF', 'Congestive Heart Failure With Ablation', 'Patients with persistent/longstanding persistent AF and LVEF ≤35', '68 and 72 patients', 'Patients With Persistent Atrial Fibrillation and Congestive Heart Failure', '140 patients (65±8 years, 126 [90%] men) available for the end point analysis', 'patients with seriously advanced HF', 'patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF']","['catheter ablation of AF', 'catheter ablation of AF or best medical therapy (BMT', 'Catheter Ablation Versus Best Medical Therapy', 'cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted']","['LVEF', '12-lead electrocardiograms', 'absolute increase in LVEF', 'Sinus rhythm', '6-minute walk test, quality-of-life, and NT-proBNP', 'rate or rhythm control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",140.0,0.127378,The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF.,"[{'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany (K.-H.K., R.R.T.).'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis Medical University, Budapest, Hungary (B.M., L.G.).'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': 'Heart Center, Ludwigshafen, Germany (R.Z.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Arentz', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Germany (T.A.).'}, {'ForeName': 'Karlheinz', 'Initials': 'K', 'LastName': 'Seidl', 'Affiliation': 'Klinikum Ingolstadt GmbH, Ingolstadt, Germany (K.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schlüter', 'Affiliation': 'Asklepios Proresearch, Hamburg (M.S.).'}, {'ForeName': 'Roland Richard', 'Initials': 'RR', 'LastName': 'Tilz', 'Affiliation': 'Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany (K.-H.K., R.R.T.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Piorkowski', 'Affiliation': 'Heart Center, University of Leipzig (C.P., G.H.).'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Gellér', 'Affiliation': 'Semmelweis Medical University, Budapest, Hungary (B.M., L.G.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kleemann', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Heart Center, University of Leipzig (C.P., G.H.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007731'] 1029,31180474,Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial.,"Importance Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient. Objective To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes. Design, Setting, and Participants Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment. Interventions Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches. Main Outcomes and Measures Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care. Results Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings. Conclusions and Relevance An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults. Trial Registration ClinicalTrials.gov identifier: NCT02316223.",2019,"Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]).","['Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center', '1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate', 'older adults with asthma', '391 patients received the allocated treatment', 'Older Adults', 'Older adults with asthma', 'Participants\n\n\nThree-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City', 'older adults', '391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years']","['Self-management Support Intervention', 'home-based intervention, clinic-based intervention, or control (usual care', 'comprehensive, patient-tailored asthma self-management support intervention']","['asthma control test', 'asthma outcomes and self-management behaviors', 'medication adherence', 'Emergency department visits', 'Asthma Outcomes', 'Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care', 'quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517858', 'cui_str': '7.4'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1319219', 'cui_str': 'Asthma self-management'}]","[{'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C2919855', 'cui_str': 'Mini asthma quality of life questionnaire'}, {'cui': 'C0222045'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0034380'}]",391.0,0.0720177,"Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]).","[{'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'Federman', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Conor"", 'Affiliation': 'Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Mindlis', 'Affiliation': 'Department of Psychology, The Graduate Center, City University of New York, New York, New York.'}, {'ForeName': 'Jamillah', 'Initials': 'J', 'LastName': 'Hoy-Rosas', 'Affiliation': 'City Health Works, New York, New York.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hauser', 'Affiliation': 'Institute for Family Health, New York, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lurio', 'Affiliation': 'Institute for Family Health, New York, New York.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Shroff', 'Affiliation': 'Institute for Family Health, New York, New York.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Lopez', 'Affiliation': 'Little Sisters of the Assumption Family Health Service, New York, New York.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Erblich', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wisnivesky', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.1201'] 1030,31764564,Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Eustachian Tube Function.,"INTRODUCTION Adenoidectomy is one of the most common surgical procedures performed in children in otorhinolaryngology practice. This study aims to compare the conventional curettage adenoidectomy (CCA) and the endoscope-assisted coblation adenoidectomy (EACA) in terms of the postoperative Eustachian tube function and the surgical outcomes. METHODS A prospective, randomized, controlled study was carried out at a tertiary referral center and private hospital. Seventy-two adenoid hypertrophy patients without middle ear disease were randomly assigned to 2 groups to be operated via CCA and EACA techniques prior to surgery. Parameters including middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain were compared between groups. RESULTS In the CCA group for both ears, there was a statistically significant difference between preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV returned to normal ranges at the postoperative day 7. No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears. Mean operative time was significantly higher in the EACA group compared to the CCA group (P < 0.001). Eight (22.2%) out of 36 patients who underwent CCA had a residual adenoid tissue postoperatively, while there was no residual adenoid tissue in any patients who operated via the EACA technique. Mean pain score on postoperative day 1 and 2 and blood loss were significantly less in the EACA group than the CCA group. CONCLUSION Endoscope-assisted coblation adenoidectomy may serve a reasonable alternative to conventional curettage adenoidectomy because it provides Eustachian tube functions preserved, decreased intraoperative hemorrhage, complete resection of the adenoid tissue, and lower pain score.",2020,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"['tertiary referral center and private hospital', 'Seventy-two adenoid hypertrophy patients without middle ear disease']","['EACA', 'endoscope-assisted coblation adenoidectomy (EACA', 'CCA', 'Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy', 'conventional curettage adenoidectomy (CCA', 'Endoscope-assisted coblation adenoidectomy', 'CCA and EACA techniques prior to surgery']","['Mean pain score on postoperative day 1 and 2 and blood loss', 'preoperative mean MEPV and mean MEPV of postoperative day 1, while MEPV', 'Postoperative Eustachian Tube Function', 'Mean operative time', 'middle ear pressure values (MEPV), operative time, intraoperative hemorrhage, postoperative residual adenoid tissue, and postoperative pain', 'mean MEPV']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0457584', 'cui_str': 'Eustachian tube function (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0457587', 'cui_str': 'Middle ear pressure (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0001428', 'cui_str': 'Pharyngeal Tonsils'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.043658,No statistically significant differences were observed in mean MEPV on preoperatively and 1st and 7th postoperative days in the EACA group for both right and left ears.,"[{'ForeName': 'Secaattin', 'Initials': 'S', 'LastName': 'Gülşen', 'Affiliation': 'Department of Otorhinolaryngology, Dr Ersin Arslan Training And Research Hospital.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Çikrikçi', 'Affiliation': 'Department of Otorhinolaryngology, Yozgat State Hospital, Yozgat, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006039'] 1031,31763933,Pathways to Recovery among Homeless People with Mental Illness: Is Impulsiveness Getting in the Way?,"OBJECTIVE This study investigates the association between impulsiveness and six dimensions of recovery among homeless people with mental illness. METHOD The sample was composed of 418 participants of a randomized controlled trial of Housing First, a recovery-oriented program that provides immediate access to permanent housing. The reliable change index method was used to provide an estimate of the statistical and clinical significance of the change from baseline to 24 months (i.e., clinically meaningful improvement), on outcomes that pertain to recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential). We tested for the effect of impulsiveness, assessed with the Barratt Impulsiveness Scale-11, on clinically meaningful improvement on each specific outcome, adjusting for age, gender and intervention assignment, as both intervention arms were included in the analysis. RESULTS For every increase in total impulsiveness score by one standard deviation, the odds of experiencing clinically meaningful improvement decreased by 29% ( OR = 0.71, 95% CI, 0.55 to 0.91) on the clinical dimension and by 53% ( OR = 0.47, 95% CI, 0.32 to 0.68) on the existential dimension. However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. CONCLUSIONS Findings highlight the importance of addressing impulsiveness in the context of recovery-oriented interventions for homeless people with mental illness. Further research may be required to improve interventions that are responsive to unique needs of impulsive individuals to support clinical and existential recovery.",2019,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. ","['418 participants', 'homeless people with mental illness', 'Homeless People with Mental Illness']",[],"['recovery dimensions: psychiatric symptoms (clinical), physical health and substance use problems (physical), residential stability (functional), arrests (criminological), community integration (social), and hope and personal confidence (existential', 'physical, functional, criminological, and social dimensions', 'total impulsiveness score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]",[],"[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",418.0,0.0674948,"However, changes in outcomes pertaining to physical, functional, criminological, and social dimensions were not significantly influenced by impulsiveness. ","[{'ForeName': 'Marichelle C', 'Initials': 'MC', 'LastName': 'Leclair', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Ashley J', 'Initials': 'AJ', 'LastName': 'Lemieux', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Roy', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Douglas Mental Health University Institute, Montréal, Québec, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Institut national de psychiatrie légale Philippe-Pinel, Montréal, Québec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743719885477'] 1032,31764387,New procedure of high-frequency repetitive transcranial magnetic stimulation for central neuropathic pain: a placebo-controlled randomized crossover study.,"Repetitive transcranial magnetic stimulation (rTMS) is a procedure increasingly used to treat patients with central neuropathic pain, but its efficacy is still under debate. Patients with medically refractory chronic central neuropathic pain were included in 2 randomized phases (active/sham), separated by a wash-out period of 8 weeks. Each phase consisted of 4 consecutive rTMS sessions and a final evaluation session, all separated from one another by 3 weeks. High-frequency (20 Hz) rTMS was delivered over the primary motor cortex (M1) contralateral to the patient's pain using a neuronavigated robotic system. Patients and clinicians assessing outcomes were blinded to treatment allocation during the trial. The primary outcome measured the percentage of pain relief (%R) from baseline. Secondary outcomes were VAS score, Neuropathic Pain Symptom Inventory, analgesic drug consumption, and quality of life (EQ-5D). Thirty-six patients performed the entire study with no adverse effects. The analgesic effect for the main criterion (%R) was significantly higher in the active (33.8% confidence interval [CI]: [23.88-43.74]) than in the sham phase (13.02% CI: [6.64-19.76]). This was also the case for the secondary outcome VAS (-19.34% CI: [14.31-25.27] vs -4.83% CI: [1.96-8.18]). No difference was observed for quality of life or analgesic drug consumption. Seventeen patients (47%) were identified as responders, but no significant interaction was found between clinical and technical factors considered here and the analgesic response. These results provide strong evidence that 3 weeks spaced high-frequency rTMS of M1 results in a sustained analgesic effect and support the clinical interest of this stimulation paradigm to treat refractory chronic pain.",2020,The analgesic effect for the main criterion (%R) was significantly higher in the active (33.8% CI: [23.88-43.74]) than in the sham phase (13.02% CI:[6.64-19.76]).,"['patients with central neuropathic pain (CNP', 'central neuropathic pain', 'Patients with medically refractory chronic CNP']","['placebo', 'Repetitive transcranial magnetic stimulation (rTMS', 'high-frequency repetitive transcranial magnetic stimulation', 'High-frequency (20Hz) rTMS']","['analgesic response', 'percentage of pain relief', 'VAS score, Neuropathic Pain Symptom Inventory (NPSI), analgesic drug consumption and quality of life', 'analgesic effect', 'quality of life or analgesic drug consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0034380'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.517819,The analgesic effect for the main criterion (%R) was significantly higher in the active (33.8% CI: [23.88-43.74]) than in the sham phase (13.02% CI:[6.64-19.76]).,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Quesada', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pommier', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Fauchon', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bradley', 'Affiliation': 'Queensland Brain Institute, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Créacʼh', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Murat', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vassal', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Peyron', 'Affiliation': ""Laboratoire Intégration Centrale de la Douleur chez l'Homme (NeuroPain), Centre de Recherche en Neurosciences de Lyon, INSERM U1028, Bron, France.""}]",Pain,['10.1097/j.pain.0000000000001760'] 1033,31530667,"Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.","OBJECTIVE To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg ( N = 184), 7 mg ( N = 182), or 14 mg ( N = 181) or to placebo ( N = 184) in a 52-week, double-blind trial. End points were change from baseline to week 26 in HbA 1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients. RESULTS Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment difference [ETD] -0.5% [95% CI -0.7, -0.3], -0.9% [-1.1, -0.7], and -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P < 0.001) and body weight (ETD -0.9 kg [95% CI -1.8, -0.0], -2.0 kg [-3.0, -1.0], and -3.3 kg [-4.2, -2.3]; P = 0.0392 for 3 mg, P ≤ 0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand). Significantly greater dose-dependent HbA 1c and body weight reductions versus placebo were achieved with oral semaglutide at weeks 26 and 52 (both estimands). The most frequent adverse event with oral semaglutide was nausea (11.4-23.2% of patients vs. 7.1% with placebo; mostly mild to moderate). CONCLUSIONS Oral semaglutide was superior to placebo in reducing HbA 1c and body weight when added to insulin with or without metformin in patients with type 2 diabetes. The safety profile was consistent with other glucagon-like peptide 1 receptor agonists.",2019,"RESULTS Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P <0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P =0.0392 for 3 mg, P ≤0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand).","['patients with type 2 diabetes', 'Patients with type 2 diabetes uncontrolled on insulin, ±', 'Patients with Type 2 Diabetes']","['insulin ± metformin', 'metformin', 'Insulin ± Metformin', 'oral semaglutide', 'Oral Semaglutide Versus Placebo', 'placebo', 'oral semaglutide added to insulin ± metformin']","['dose-dependent HbA 1c , and body weight reductions', 'HbA 1c and body weight', 'body weight', 'reducing HbA 1c', 'Efficacy, Safety and Tolerability', 'efficacy, safety and tolerability', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.109896,"RESULTS Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P <0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P =0.0392 for 3 mg, P ≤0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand).","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada zinman@lunenfeld.ca.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Department of Endocrinology, L'Institut du Thorax, CIC INSERM 1413, CHU Nantes, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stewart B', 'Initials': 'SB', 'LastName': 'Harris', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Søren Tetens', 'Initials': 'ST', 'LastName': 'Hoff', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karen Boje', 'Initials': 'KB', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mads Jeppe', 'Initials': 'MJ', 'LastName': 'Tarp-Johansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0898'] 1034,30506301,A Videogame-Based Digital Therapeutic to Improve Processing Speed in People with Multiple Sclerosis: A Feasibility Study.,"INTRODUCTION Self-administered in-home digital therapeutics could expand access to cognitive rehabilitation for individuals with multiple sclerosis (MS), over half of whom experience cognitive impairment (CI). However, feasibility in an MS population must be clarified. This study was conducted to assess the feasibility of deploying a videogame-like digital treatment for CI in MS, including initial efficacy and barriers to adherence. METHODS In this pilot study, 21 participants with MS completed an in-clinic baseline neurological evaluation. Cognitive tests included paper-and-pencil Brief International Cognitive Assessment for Multiple Sclerosis [BICAMS-which included the Symbol Digit Modalities Test (SDMT)] and other unsupervised tablet-based tests (including Match: an unsupervised test of executive functions and processing speed, developed at UCSF; and the Cogstate MS Battery). Participants then completed an in-home, tablet-based, videogame-like investigational digital treatment (Project: EVO™) for 25 min daily, 5 days weekly, for 4 weeks. This was followed by a repeat in-clinic evaluation. RESULTS Of the 21 participants (mean [standard deviation, SD] age 53.8 [11.6] years, median Expanded Disability Status Scale (EDSS) 2.5 [SD 2.0, IQR [2-3.5]]) enrolled to use the digital therapeutic at home (mean [SD] SDMT z score: - 0.21 [1.16]), 18 completed the study, during which they completed an average of 19.7 days (median [SD]: 20.5 [8.4]). Overall, 78% of these 18 participants completed 75% of prescribed days (i.e., at least 15), and 50% completed all 20 days or more. Over the 4-week period, scores of processing speed improved significantly (based on one-sided t test), including SDMT (p = 0.003) and Match (p = 0.006). The Cogstate DET test (psychomotor function) also increased (p = 0.006). Mean increase in SDMT was 3.6 points. Male sex, not being employed, and higher baseline anxiety all were significantly associated with greater improvement in SDMT over the 4-week period. Interestingly, lower baseline cognitive scores were associated with greater number of sessions completed (e.g., SDMT: p = 0.003, R 2  = 0.44). Adjusting for employment, a proxy for time available, did not significantly improve the model fit. DISCUSSION Deploying an in-home digital tool to improve processing speed in MS is feasible, and shows preliminary efficacy. A larger, randomized controlled clinical trial is ongoing.",2019,"Over the 4-week period, scores of processing speed improved significantly (based on one-sided t test), including SDMT (p = 0.003) and Match (p = 0.006).","['People with Multiple Sclerosis', 'individuals with multiple sclerosis (MS), over half of whom experience cognitive impairment (CI', '21 participants with MS completed an in-clinic baseline neurological evaluation', 'Of the 21 participants (mean [standard deviation, SD] age 53.8 [11.6] years, median Expanded Disability Status Scale (EDSS) 2.5 [SD 2.0, IQR [2-3.5]]) enrolled to use the digital therapeutic at home']",[],"['Cogstate DET test (psychomotor function', 'Mean increase in SDMT', 'baseline cognitive scores', 'scores of processing speed', 'SDMT']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],"[{'cui': 'C0027170', 'cui_str': 'N,-N-diethyltryptamine (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",21.0,0.0627756,"Over the 4-week period, scores of processing speed improved significantly (based on one-sided t test), including SDMT (p = 0.003) and Match (p = 0.006).","[{'ForeName': 'Riley M', 'Initials': 'RM', 'LastName': 'Bove', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA. Riley.bove@ucsf.edu.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Rush', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rowles', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Garcha', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Morrissey', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Schembri', 'Affiliation': 'Cogstate, Inc., Melbourne, Australia.'}, {'ForeName': 'Titi', 'Initials': 'T', 'LastName': 'Alailima', 'Affiliation': 'Akili Interactive, Boston, MA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Langdon', 'Affiliation': 'Royal Holloway, University of London, Egham, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Possin', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Anguera', 'Affiliation': 'Department of Neurology, Weill Institute for the Neurosciences, University of California, San Francisco, USA.'}]",Neurology and therapy,['10.1007/s40120-018-0121-0'] 1035,31162597,Glucose- and Lipid-Related Biomarkers Are Affected in Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics: A 12-Week Randomized Controlled Trial.,"BACKGROUND Synbiotic foods, which combine the action of prebiotics and probiotics along the gastrointestinal tract, can affect inflammatory and glucose-related markers. OBJECTIVE The aim of this study was to investigate the effects on inflammatory and glycemia-related markers of a whole-grain pasta containing barley β-glucans and Bacillus coagulans BC30, 6086 in healthy overweight or obese volunteers. METHODS A single-blind, parallel, randomized, placebo-controlled dietary intervention study was carried out. Forty-one healthy sedentary overweight (body mass index [BMI] 25-29.9 kg/m2) and obese (BMI ≥30) volunteers, aged 30-65 y and low consumers of fruit and vegetables, ate 1 serving/d of whole-grain control (CTR) or innovative (INN) pasta for 12 wk and maintained their habitual diets. Biological samples were collected at baseline and every 4 wk for primary (plasma high-sensitivity C-reactive protein [hs-CRP] and fasting plasma lipid profile) and secondary outcomes (glycemia-related markers, blood pressure, fecal microbiota composition, and body weight). Between (CTR compared with INN) and within (among weeks) group differences were tested for the whole population and for subgroups stratified by baseline values of BMI (≥30) and glycemia (≥100 mg/dL). RESULTS INN or CTR pasta consumption had no effect on primary and secondary outcomes over time, except for a significant increase in plasma γ-glutamyltransferase (GGT) after 12 wk of CTR pasta consumption. Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp. were lower in the INN subgroup of obese volunteers; plasma resistin was lower and Faecalibacterium prausnitzii abundance was higher in the INN subgroup of hyperglycemic volunteers. CONCLUSIONS A daily serving of a synbiotic whole-grain pasta had limited effects on primary and secondary outcomes in the entire group of volunteers but affected glycemia- and lipid-related markers and resistin in a subgroup of healthy obese or hyperglycemic volunteers. This trial was registered at clinicaltrials.gov as NCT02236533.",2019,"Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp.","['BMI] 25-29.9 kg/m2) and obese (BMI ≥30) volunteers, aged 30-65 y and low consumers of fruit and vegetables, ate 1 serving/d of whole-grain control (CTR) or innovative (INN) pasta for 12 wk and maintained their habitual diets', 'Forty-one healthy sedentary overweight (body mass index', 'Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics', 'healthy overweight or obese volunteers', 'healthy obese or hyperglycemic volunteers']","['placebo-controlled dietary intervention', 'synbiotic whole-grain pasta']","['plasma γ-glutamyltransferase (GGT', 'fasting plasma lipid profile) and secondary outcomes (glycemia-related markers, blood pressure, fecal microbiota composition, and body weight', 'plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp', 'Faecalibacterium prausnitzii abundance', 'plasma GGT']","[{'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0452694', 'cui_str': 'Pasta (substance)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0317558', 'cui_str': 'Fusobacterium prausnitzii'}]",41.0,0.183307,"Comparisons between intervention groups revealed differences only at 12 wk: plasma GGT was higher in the CTR group; plasma hs-CRP, plasma LDL/HDL cholesterol ratio, and Bifidobacterium spp.","[{'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Martina', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Veronesi', 'Affiliation': 'Public Health Unit, Department of Medicine and Surgery.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Division of Endocrinology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Mennella', 'Affiliation': 'Department of Agricultural and Food Science, University of Naples ""Federico II"", Portici, Naples, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural and Food Science, University of Naples ""Federico II"", Portici, Naples, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Grioni', 'Affiliation': 'Epidemiology and Prevention Unit, Fondazione IRCSS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Zavaroni', 'Affiliation': 'Division of Endocrinology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Fares', 'Affiliation': 'Council for Agricultural Research and Economics-Centre for Cereal Research and Industrial Crops, Foggia, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Torriani', 'Affiliation': 'Department of Biotechnology, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pellegrini', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drugs.'}]",The Journal of nutrition,['10.1093/jn/nxz071'] 1036,31397184,"Bronchodilator efficacy of tiotropium/formoterol (18/12 µg once daily via a Discair inhaler), tiotropium alone (18 µg by Handihaler) or combined with formoterol (12 µg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD.","Objectives: The bronchodilator efficacy of a once-daily fixed-dose combination of tiotropium/formoterol (18/12 µg administered via a dry-powder inhaler, Discair) [TIO/FORM fixed group] vs a single-dose of tiotropium (18 µg) by Handihaler 1 alone [TIO mono group], or combined with formoterol 12 µg twice-daily by Aerolizer 2 [TIO/FORM bid group] was compared in patients with moderate-to-severe stable COPD. Methods: COPD patients were randomized (28 patients/group) to receive TIO/FORM fixed , TIO mono , or TIO/FORM bid . AUC for the changes in FEV 1 and FVC over a 24-h period; bronchodilator response (100 ml improvement in FEV 1 ) in the first 30 min; maximum changes in FEV 1 and FVC; and safety data were recorded. The primary endpoint was to confirm the non-inferiority of TIO/FORM fixed vs TIO/FORM bid in terms of the AUC for the changes in FEV 1 over a 24-h period. Results: Changes in AUC 0-24h for FEV 1 and FVC were similar for TIO/FORM fixed and TIO/FORM bid , and were superior to TIO mono ( p  < 0.001). A positive bronchodilator response at 30 min was demonstrated in 50%, 64%, and 71% of patients in the TIO mono , TIO/FORM bid , and TIO/FORM fixed groups, respectively (NS). Maximum FEV 1 and FVC changes were measured as 0.25/0.41 L, 0.32/0.49 L, and 0.37/0.53 L, for TIO mono , TIO/FORM bid , and TIO/FORM fixed , respectively (FEV 1 : TIO/FORM fixed vs TIO mono , p  = 0.0017 and TIO/FORM fixed vs TIO/FORM bid , p  = 0.4846); no differences were recorded between the combination groups. Conclusions: The 24-h bronchodilator efficacy of TIO/FORM fixed 18/12 µg once-daily by Discair 3 was non-inferior to a combination of tiotropium 18 µg by Handihaler plus formoterol 12 µg twice-daily by Aerolizer, and superior to tiotropium 18 µg monotherapy by Handihaler.",2019,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid and TIO/FORM fixed groups, respectively (NS).","['adults with moderate-to-severe stable COPD', 'COPD patients']","['tiotropium/formoterol', 'tiotropium', 'TIO/FORM fixed , TIO mono or TIO/FORM bid ', 'tiotropium alone (18 µg by Handihaler®) or combined with formoterol', 'FVC', 'Discair®', 'Handihaler® alone [TIO mono group], or combined with formoterol 12 µg twice-daily by Aerolizer']","['Bronchodilator efficacy', '24-h bronchodilator efficacy', 'bronchodilator efficacy', 'Maximum FEV 1 and FVC changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C2355432', 'cui_str': 'TiO(tpyp)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.180891,"A positive bronchodilator response at 30 minutes was demonstrated in 50%, 64% and 71% of patients in the TIO mono , TIO/FORM bid and TIO/FORM fixed groups, respectively (NS).","[{'ForeName': 'Birsen Pinar', 'Initials': 'BP', 'LastName': 'Yildiz', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Bayraktaroglu', 'Affiliation': 'Department of Pulmonary Medicine, Yedikule Research and Training Center for Chest Diseases and Thoracic Surgery, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gunen', 'Affiliation': 'Department of Chest Diseases and Thoracic Surgery, Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Istanbul, Turkey.'}]",Current medical research and opinion,['10.1080/03007995.2019.1654722'] 1037,31548244,Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial.,"OBJECTIVE In type 2 diabetes, insulin resistance and progressive β-cell failure require treatment with high insulin doses, leading to weight gain. Our aim was to study whether a three-meal diet (3Mdiet) with a carbohydrate-rich breakfast may upregulate clock gene expression and, as a result, allow dose reduction of insulin, leading to weight loss and better glycemic control compared with an isocaloric six-meal diet (6Mdiet). RESEARCH DESIGN AND METHODS Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2 and HbA 1c 8.1 ± 1.1% [64.5 ± 11.9 mmol/mol]) were randomly assigned to 3Mdiet or 6Mdiet. Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression were assessed at baseline, after 2 weeks, and after 12 weeks. RESULTS 3Mdiet, but not 6Mdiet, led to a significant weight loss (-5.4 ± 0.9 kg) ( P < 0.01) and decreased HbA 1c (-12 mmol/mol [-1.2%]) ( P < 0.0001) after 12 weeks. Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet. CGM showed a significant decrease in the time spent in hyperglycemia only on the 3Mdiet. Total daily insulin dose was significantly reduced by 26 ± 7 units only on the 3Mdiet. There was a significant decrease in the hunger and cravings only in the 3Mdiet group. Clock genes exhibited oscillation, increased expression, and higher amplitude on the 3Mdiet compared with the 6Mdiet. CONCLUSIONS A 3Mdiet, in contrast to an isocaloric 6Mdiet, leads to weight loss and significant reduction in HbA 1c , appetite, and overall glycemia, with a decrease in daily insulin. Upregulation of clock genes seen in this diet intervention could contribute to the improved glucose metabolism.",2019,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"['Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2 and HbA 1c 8.1 ± 1.1% [64.5 ± 11.9 mmol/mol', 'Patients With Type']","['3Mdiet or 6Mdiet', 'isocaloric six-meal diet (6Mdiet', 'meal diet (3Mdiet) with a carbohydrate-rich breakfast', 'CGM']","['time spent in hyperglycemia', 'weight loss, significant reduction in HbA 1c , appetite, and overall glycemia', 'Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression', 'glucose metabolism', 'Fasting glucose and daily and nocturnal glucose levels', 'Total daily insulin dose', 'hunger and cravings', 'weight loss', 'daily insulin', 'Glycated Hemoglobin and Daily Insulin Dose']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",28.0,0.0205284,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Jakubowicz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel daniela.jak@gmail.com.'}, {'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Landau', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Tsameret', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ahren', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Chapnik', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Barnea', 'Affiliation': 'Department of Molecular Genetics, Faculty of Biochemistry, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Ganz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menaged', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Mor', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Yosefa', 'Initials': 'Y', 'LastName': 'Bar-Dayan', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel oren.froy@mail.huji.ac.il.'}]",Diabetes care,['10.2337/dc19-1142'] 1038,31174214,Fiber Intake Predicts Weight Loss and Dietary Adherence in Adults Consuming Calorie-Restricted Diets: The POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study.,"BACKGROUND The effects of dietary composition on weight loss are incompletely understood. In addition to energy intake, fiber intake, energy density, macronutrient composition, and demographic characteristics have all been suggested to contribute to weight loss. OBJECTIVE The primary aim of this analysis was to assess the role of dietary fiber as a predictor of weight loss in participants who consumed calorie-restricted diets (-750 kcal/d from estimated energy needs) for 6 mo, using data from the POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study-a randomized trial that examined the effects of calorie-restricted diets varying in macronutrient composition on weight loss in adults. METHODS Data were randomly partitioned to a training data set (70%) in which the effects of fiber and other weight-loss predictors were identified using adjusted Least Absolute Shrinkage and Selection Operator and model averaging. The retained predictors were then fit on the testing data set to assess predictive performance. RESULTS Three hundred and forty-five participants (53.9% female) provided dietary records at baseline and 6 mo. Mean ± SD age and BMI for the full sample was 52.5 ± 8.7 y and 32.6 ± 3.9 kg/m2, respectively. Mean ± SD (99% CI) weight change at 6 mo for the full sample was -7.27 ± 5.6 kg (-8.05, -6.48 kg). The final, best fit model (R2 = 0.41) included fiber, energy density, fat, age, adherence, baseline weight, race, and changes from baseline in carbohydrate, fiber, PUFA, and MUFA intake, but the most influential predictor was fiber intake ($\hat{\beta }$ = -0.37; P < 0.0001). In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001). Interactions between race and adherence, age, baseline weight, carbohydrate, energy density, and MUFAs were also retained in the final model. CONCLUSION Dietary fiber intake, independently of macronutrient and caloric intake, promotes weight loss and dietary adherence in adults with overweight or obesity consuming a calorie-restricted diet. This trial was registered at clinicaltrials.gov as NCT00072995.",2019,"In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001).","['Adults', 'adults with overweight or obesity consuming a calorie-restricted diet', 'Three hundred and forty-five participants (53.9% female) provided dietary records at baseline and 6 mo', 'participants who consumed calorie-restricted diets (-750 kcal/d from estimated energy needs) for 6 mo, using data from the POUNDS Lost (Preventing Overweight', 'adults']","['Consuming Calorie-Restricted Diets', 'calorie-restricted diets varying in macronutrient composition']","['weight loss', 'Mean\xa0±\xa0SD age and BMI', 'fiber, energy density, fat, age, adherence, baseline weight, race, and changes from baseline in carbohydrate, fiber, PUFA, and MUFA intake', 'Mean\xa0±\xa0SD (99% CI) weight change', 'fiber intake ($\\hat{\\beta ', 'weight loss and dietary adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",345.0,0.0751273,"In addition, fiber was strongly associated with adherence to the macronutrient prescriptions (P < 0.0001).","[{'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Miketinas', 'Affiliation': ""Department of Nutrition and Food Sciences, Texas Woman's University, Houston, TX, USA.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz117'] 1039,15121812,Clinical management of children and young adults with heterozygous familial hypercholesterolaemia in the UK.,"Life expectancy in familial hypercholesterolaemia (FH) has been greatly improved by the advent of statin therapy. In the UK, however, these agents are not licensed for use in children. We approached 169 physicians responsible for lipid clinics for information on their practice in young patients, and valid responses were received from 54%. A typical lipid clinic has only 3.5 patients aged under 16 with FH. In boys aged 10-15 years 65% of physicians were prepared to treat with bile acid sequestrants but only 23% with statins. There was greater reluctance to treat in girls of the same age, corresponding figures being 52% and 12%. Despite the efficacy of statins in reducing low-density-lipoprotein cholesterol, these agents are little used in children with FH. Their safety and clinical efficacy should be assessed by a randomized double-blind trial.",2004,"There was greater reluctance to treat in girls of the same age, corresponding figures being 52% and 12%.","['children and young adults with heterozygous familial hypercholesterolaemia in the UK', '3.5 patients aged under 16 with FH', 'children with FH', '169 physicians responsible for lipid clinics for information on their practice in young patients', 'familial hypercholesterolaemia (FH']",['statins'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}]",[],169.0,0.101719,"There was greater reluctance to treat in girls of the same age, corresponding figures being 52% and 12%.","[{'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Greene', 'Affiliation': 'University Department of Medicine, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Durrington', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1040,31563095,"The effects of a working memory load on drinking-related decisions: The role of incentives, disincentives, and lifetime alcohol problems.","BACKGROUND This study extends this literature on effects of working memory (WM) load on impulsive and disadvantageous decision-making by investigating the impact of WM load on drinking-related decisions in different incentive and disincentive contexts in a large sample (n = 821, 373 women) of young adults, 558 of whom had an alcohol use disorder (AUD). METHODS Decisions to attend and drink at hypothetical party events that varied in terms of alcohol party incentives (high vs low) and next day responsibility disincentives (high vs moderate vs low) were assessed. Subjects were randomly assigned to either a WM load (n = 387) or no load condition (n = 434). RESULTS Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts. This effect was not found in the moderate or low disincentive contexts. Additionally, a WM load increased the effects of high alcohol party incentives on both decisions to attend and drink. The WM load also resulted in faster attendance decision reaction times, suggesting that subjects were more impulsive under load. CONCLUSIONS These results suggest that a WM load had a general effect of disrupting the decision-making process, reducing the inhibitory effects of high disincentives, amplifying the facilitating effects of high party incentives on alcohol-related decisions, and reducing decision deliberation times (reaction times). This suggests that individuals under significant cognitive load engage in more impulsive and riskier decisions when deciding to attend and drink at party events.",2019,"RESULTS Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts.","['a large sample (n\u202f=\u202f821, 373 women) of young adults, 558 of whom had an alcohol use disorder (AUD']","['WM load (n\u202f=\u202f387) or no load condition', 'working memory (WM', 'working memory load']",['attendance decision reaction times'],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}]",373.0,0.0315715,"RESULTS Analyses revealed that the WM load reduced the degree to which a high disincentive deterred attendance decisions; attendance decisions were more likely under WM load in the high disincentive contexts.","[{'ForeName': 'Polly F', 'Initials': 'PF', 'LastName': 'Ingram', 'Affiliation': 'Department of Psychological and Brain Sciences, 1101 E 10th St, Indiana University, Bloomington, IN, 47405, United States.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Finn', 'Affiliation': 'Department of Psychological and Brain Sciences, 1101 E 10th St, Indiana University, Bloomington, IN, 47405, United States. Electronic address: finnp@indiana.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107567'] 1041,30819262,Vitamin D3 supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women.,"The effect of 38 µg (1500 IU) daily vitamin D3 supplementation, consumed with an Fe-fortified breakfast cereal for 8 weeks, on haematological indicators in Fe-deficient female subjects was investigated. Fifty Fe-deficient subjects (plasma ferritin concentration <20 µg/l; mean age: 27·4 (sd 9·4) years) were randomised to consume an Fe-fortified breakfast cereal containing 9 mg of Fe daily, with either a vitamin D3 supplement or placebo. Blood samples were collected at baseline, interim (4 weeks) and post-intervention (8 weeks) for measurement of Fe and vitamin D status biomarkers. The effect of intervention was analysed using mixed-model repeated-measures ANOVA. Significant increases were observed in two main haematological indices: Hb concentration and haematocrit level from baseline to post-intervention in the vitamin D group but not in the placebo group. The increase from baseline to post-intervention in Hb concentration in the vitamin D group (135 (sd 11) to 138 (sd 10) g/l) was significantly higher compared with the placebo group (131 (sd 15) to 128 (sd 13) g/l) (P=0·037). The increase in haematocrit level from baseline to post-intervention was also significantly higher in the vitamin D group (42·0 (sd 3·0) to 43·8 (sd 3·4) %) compared with the placebo group (41·2 (sd 4·3) to 40·7 (sd 3·6) %) (P=0·032). Despite the non-significant changes in plasma ferritin concentration, this study demonstrates that 38 µg supplemental vitamin D, consumed daily, with Fe-fortified breakfast cereal led to improvement in Hb concentration and haematocrit levels in women with low Fe stores. These findings may have therapeutic implications in the recovery of Fe status in Fe-deficient populations at a healthcare level.",2019,Significant increases were observed in two main haematological indices: Hb concentration and haematocrit level from baseline to post-intervention in the vitamin D group but not in the placebo group.,"['9·4) years', 'women with low Fe stores', 'Fe-deficient female subjects', 'Fifty Fe-deficient subjects (plasma ferritin concentration <20 µg/l; mean age: 27·4 (sd', 'iron-deficient women']","['vitamin D', 'placebo', 'vitamin D3 supplementation, consumed with an Fe-fortified breakfast cereal', 'Fe-fortified breakfast cereal containing 9 mg of Fe daily, with either a vitamin D3 supplement or placebo', 'Vitamin D3 supplementation']","['Hb concentration', 'Blood samples', 'haematocrit level', 'haematological status', 'haematological indices: Hb concentration and haematocrit level', 'plasma ferritin concentration', 'Hb concentration and haematocrit levels']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}]",,0.428921,Significant increases were observed in two main haematological indices: Hb concentration and haematocrit level from baseline to post-intervention in the vitamin D group but not in the placebo group.,"[{'ForeName': 'Salma F', 'Initials': 'SF', 'LastName': 'Ahmad Fuzi', 'Affiliation': '1Faculty of Medicine,Dentistry and Life Sciences,University of Chester,Parkgate Road,ChesterCH1 4BJ,UK.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': '1Faculty of Medicine,Dentistry and Life Sciences,University of Chester,Parkgate Road,ChesterCH1 4BJ,UK.'}]",The British journal of nutrition,['10.1017/S0007114519000412'] 1042,31620980,"Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab.","ABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer. ABP 980 is approved in the United States, European Union, and Japan for all the indications of trastuzumab, based on the totality of evidence (TOE) gathered by the systematic step-wise accumulation of comparative analytical, preclinical, and clinical (pharmacokinetics [PK], efficacy, safety and immunogenicity) data for ABP 980 and trastuzumab reference product (RP). As a key first step of the ABP 980 biosimilar program, comprehensive analytical characterization of critical quality attributes established that ABP 980 is structurally and functionally similar to trastuzumab RP. Complementing these data, results of non-clinical pharmacology, toxicology, and toxicokinetic studies supported similarity between ABP 980 and trastuzumab RP. A randomized study in healthy subjects demonstrated clinical PK equivalence of ABP 980 relative to trastuzumab RP in these subjects. In the final clinical evaluation step, a randomized comparative study (LILAC) confirmed the lack of clinically meaningful differences between ABP 980 and trastuzumab RP in efficacy, safety, and immunogenicity in women with HER2-positive EBC in the neoadjuvant-adjuvant setting. Neoadjuvant EBC represented a sensitive homogenous population for biosimilar demonstrations, and the primary endpoint of pathologic complete response served as a sensitive surrogate endpoint. An important aspect of the LILAC study design is that it is the only study that evaluated the effect of switching from the trastuzumab RP to a trastuzumab biosimilar during the adjuvant phase. No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab. Overall, the TOE data generated for ABP 980 support the conclusion that it is highly similar to trastuzumab RP, thus providing the scientific justification for extrapolation to all the approved indications of trastuzumab.",2019,"No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab.","['HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer', 'healthy subjects', 'women with HER2-positive EBC in the neoadjuvant-adjuvant setting']",[],"['efficacy, safety, and immunogenicity', 'clinical PK equivalence']","[{'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",980.0,0.021034,"No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab.","[{'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Kolberg', 'Affiliation': 'Marienhospital Bottrop GmbH, Josef-Albers-Str. 70, 46236, Bottrop, Germany. hans-christian.kolberg@mhb-bottrop.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Santi', 'Affiliation': 'Centro de Estudos de Hematologia e Oncologia, São Paulo, Brazil.'}, {'ForeName': 'Georgia Savva', 'Initials': 'GS', 'LastName': 'Demetriou', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Segui-Palmer', 'Affiliation': 'Corporació Sanitària Parc Taulí, Sabadell, Spain.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA, 90404, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc, 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.'}]",Targeted oncology,['10.1007/s11523-019-00675-z'] 1043,31157686,"A New Classification of Benign, Premalignant, and Malignant Endometrial Tissues Using Machine Learning Applied to 1413 Candidate Variables.","Benign normal (NL), premalignant (endometrial intraepithelial neoplasia, EIN) and malignant (cancer, EMCA) endometria must be precisely distinguished for optimal management. EIN was objectively defined previously as a regression model incorporating manually traced histologic variables to predict clonal growth and cancer outcomes. Results from this early computational study were used to revise subjective endometrial precancer diagnostic criteria currently in use. We here use automated feature segmentation and updated machine learning algorithms to develop a new classification algorithm. Endometrial tissue from 148 patients was randomly separated into 72-patient training and 76-patient validation cohorts encompassing all 3 diagnostic classes. We applied image analysis software to keratin stained endometrial tissues to automatically segment whole-slide digital images into epithelium, cells, and nuclei and extract corresponding variables. A total of 1413 variables were culled to 75 based on random forest classification performance in a 3-group (NL, EIN, EMCA) model. This algorithm correctly classifies cases with 3-class error rates of 0.04 (training set) and 0.058 (validation set); and 2-class (NL vs. EIN+EMCA) error rate of 0.016 (training set) and 0 (validation set). The 4 most heavily weighted variables are surrogates of those previously identified in manual-segmentation machine learning studies (stromal and epithelial area percentages, and normalized epithelial surface lengths). Lesser weighted predictors include gland and lumen axis lengths and ratios, and individual cell measures. Automated image analysis and random forest classification algorithms can classify normal, premalignant, and malignant endometrial tissues. Highest predictive variables overlap with those discovered independently in early models based on manual segmentation.",2020,This algorithm correctly classifies cases with 3-class error rates of 0.04 (training set) and 0.058 (validation set); and 2-class (NL vs. EIN+EMCA) error rate of 0.016 (training set) and 0 (validation set).,['148 patients'],['Machine Learning'],"['gland and lumen axis lengths and ratios, and individual cell measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1413.0,0.0178094,This algorithm correctly classifies cases with 3-class error rates of 0.04 (training set) and 0.058 (validation set); and 2-class (NL vs. EIN+EMCA) error rate of 0.016 (training set) and 0 (validation set).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital (M.J.D., D.J.P., G.L.M.) Department of Pathology, Harvard Medical School (D.J.P., G.L.M.) Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute (S.T.) Department of Biostatistics, Harvard T. H. Chan School of Public Health (S.T.), Boston, Massachusetts.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Papke', 'Affiliation': ''}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Tyekucheva', 'Affiliation': ''}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Mutter', 'Affiliation': ''}]",International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists,['10.1097/PGP.0000000000000615'] 1044,31697873,Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele.,"BACKGROUND Cystic fibrosis is caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and nearly 90% of patients have at least one copy of the Phe508del CFTR mutation. In a phase 2 trial involving patients who were heterozygous for the Phe508del CFTR mutation and a minimal-function mutation (Phe508del-minimal function genotype), the next-generation CFTR corrector elexacaftor, in combination with tezacaftor and ivacaftor, improved Phe508del CFTR function and clinical outcomes. METHODS We conducted a phase 3, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of elexacaftor-tezacaftor-ivacaftor in patients 12 years of age or older with cystic fibrosis with Phe508del-minimal function genotypes. Patients were randomly assigned to receive elexacaftor-tezacaftor-ivacaftor or placebo for 24 weeks. The primary end point was absolute change from baseline in percentage of predicted forced expiratory volume in 1 second (FEV 1 ) at week 4. RESULTS A total of 403 patients underwent randomization and received at least one dose of active treatment or placebo. Elexacaftor-tezacaftor-ivacaftor, relative to placebo, resulted in a percentage of predicted FEV 1 that was 13.8 points higher at 4 weeks and 14.3 points higher through 24 weeks, a rate of pulmonary exacerbations that was 63% lower, a respiratory domain score on the Cystic Fibrosis Questionnaire-Revised (range, 0 to 100, with higher scores indicating a higher patient-reported quality of life with regard to respiratory symptoms; minimum clinically important difference, 4 points) that was 20.2 points higher, and a sweat chloride concentration that was 41.8 mmol per liter lower (P<0.001 for all comparisons). Elexacaftor-tezacaftor-ivacaftor was generally safe and had an acceptable side-effect profile. Most patients had adverse events that were mild or moderate. Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group. CONCLUSIONS Elexacaftor-tezacaftor-ivacaftor was efficacious in patients with cystic fibrosis with Phe508del-minimal function genotypes, in whom previous CFTR modulator regimens were ineffective. (Funded by Vertex Pharmaceuticals; VX17-445-102 ClinicalTrials.gov number, NCT03525444.).",2019,"Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group. ","['403 patients', 'patients 12 years of age or older with cystic fibrosis with Phe508del-minimal function genotypes', 'patients who were heterozygous for the Phe508del CFTR mutation and a minimal-function mutation (Phe508del-minimal function genotype', 'patients with cystic fibrosis with Phe508del-minimal function genotypes']","['Elexacaftor-Tezacaftor-Ivacaftor', 'elexacaftor-tezacaftor-ivacaftor', 'elexacaftor-tezacaftor-ivacaftor or placebo', 'placebo', 'Elexacaftor-tezacaftor-ivacaftor']","['sweat chloride concentration', 'rate of pulmonary exacerbations', 'absolute change from baseline in percentage of predicted forced expiratory volume', 'adverse events', 'quality of life', 'Cystic Fibrosis Questionnaire-Revised']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034380'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",403.0,0.366025,"Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor-tezacaftor-ivacaftor group. ","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Middleton', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Dřevínek', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Lands', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Polineni', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Bonnie W', 'Initials': 'BW', 'LastName': 'Ramsey', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tullis', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vermeulen', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'McKee', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Simard', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waltz', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Fengjuan', 'Initials': 'F', 'LastName': 'Xuan', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': 'Raksha', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': ""From the Department of Respiratory and Sleep Medicine, Westmead Hospital and CF Research Group, Ludwig Engel Centre for Respiratory Research, Westmead Institute for Medical Research, University of Sydney, Westmead, NSW, Australia (P.G.M.); the Department of Pediatric Pulmonology, Immunology, and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.); the Department of Medical Microbiology, Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic (P.D.); the Pediatric Respiratory Medicine and Pediatric Cystic Fibrosis Clinic, McGill University Health Centre, Montreal (L.C.L.); St. Vincent's University Hospital and University College Dublin School of Medicine, Dublin (E.F.M.); the Department of Internal Medicine, University of Kansas Medical Center, Kansas City (D.P.); the Department of Pediatrics, University of Washington School of Medicine, and Seattle Children's Research Institute, Seattle (B.W.R.); the Departments of Medicine and Pediatrics, National Jewish Health, Denver (J.L.T.-C.); the Division of Respirology, St. Michael's Hospital, University of Toronto, Toronto (E.T.); the Cystic Fibrosis Reference Center, Department of Pediatrics, Catholic University of Leuven, Leuven, Belgium (F.V.); Vertex Pharmaceuticals, Boston (G.M., C.M.M., S.M.M., N.N., J.S., C.S., S.T., D.W., F.X.); the Departments of Medicine, Pediatrics, and Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham (S.M.R.); and the Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (R.J.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908639'] 1045,31687845,Considering abuse liability and neurocognitive effects of cannabis and cannabis-derived products when assessing analgesic efficacy: a comprehensive review of randomized-controlled studies.,"Background : Pain is the most frequent indication for which medical cannabis treatment is sought. Objectives : The clinical potential of cannabis and cannabis-derived products (CDPs) relies on their efficacy to treat an indication and potential adverse effects that impact outcomes, including abuse liability and neurocognitive effects. To ascertain the extent to which these effects impact therapeutic utility, studies investigating cannabis and CDPs for pain were reviewed for analgesic efficacy and assessments of abuse liability and neurocognitive effects. Methods : A comprehensive review of placebo-controlled studies investigating cannabis and CDP analgesia was performed. Methods and findings related to adverse effects, abuse liability, and neurocognitive effects were extracted. Results : Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests. Most studies ascertained adverse effects through self-report (N = 27). Fewer studies specifically probed abuse liability (N = 7) and cognitive and psychomotor effects (N = 12). Many studies related to chronic and experimental pain (N = 18 and N = 5, respectively) found cannabis and CDPs to reduce pain. Overall, adverse effects were mild to moderate, and dose-related. Studies investigating the impact of cannabis and CDPs on abuse liability and neurocognitive endpoints were mostly limited to inhaled administration and confirmed dose-related effects. Conclusion : Few studies investigating cannabis and CDP analgesia assess abuse liability and cognitive endpoints, adverse effects that impact the long-term clinical utility of these drugs. Future studies should include these measures to optimize research and clinical care related to cannabis-based therapeutics.",2019,"Overall, adverse effects were mild to moderate, and dose-related.","['Thirty-eight studies were reviewed; 29 assessed cannabis and CDPs for chronic pain, 1 for acute pain, and 8 used experimental pain tests']","['cannabis and cannabis-derived products', 'cannabis and cannabis-derived products (CDPs', ' ', 'placebo']","['analgesic efficacy', 'adverse effects, abuse liability, and neurocognitive effects', 'cognitive and psychomotor effects', 'abuse liability and neurocognitive endpoints', 'Pain', 'adverse effects']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0991028,"Overall, adverse effects were mild to moderate, and dose-related.","[{'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'UCLA Cannabis Research Initiative, Jane and Terry Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Science, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Donald I', 'Initials': 'DI', 'LastName': 'Abrams', 'Affiliation': 'Divison of Oncology, Department of Medicine, Zuckerberg San Francisco General, University of California San Francisco, San Francisco, CA, USA.'}]",The American journal of drug and alcohol abuse,['10.1080/00952990.2019.1669628'] 1046,31122901,"Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND Atezolizumab (a monoclonal antibody against PD-L1), which restores anticancer immunity, improved overall survival in patients with previously treated non-small-cell lung cancer and also showed clinical benefit when combined with chemotherapy as first-line treatment of non-small-cell lung cancer. IMpower130 aimed to assess the efficacy and safety of atezolizumab plus chemotherapy versus chemotherapy alone as first-line therapy for non-squamous non-small-cell lung cancer. METHODS IMpower130 was a multicentre, randomised, open-label, phase 3 study done in 131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel). Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease. Patients were randomly assigned (2:1; permuted block [block size of six] with an interactive voice or web response system) to receive atezolizumab (1200 mg intravenously every 3 weeks) plus chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone for four or six 21-day cycles followed by maintenance therapy. Stratification factors were sex, baseline liver metastases, and PD-L1 tumour expression. Co-primary endpoints were investigator-assessed progression-free survival and overall survival in the intention-to-treat wild-type (ie, EGFR wt and ALK wt ) population. The safety population included patients who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT02367781. FINDINGS Between April 16, 2015, and Feb 13, 2017, 724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation, but was assigned to a treatment group; this patient was excluded from the intention-to-treat population) of the atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population). Median follow-up in the intention-to-treat wild-type population was similar between groups (18·5 months [IQR 15·2-23·6] in the atezolizumab plus chemotherapy group and 19·2 months [15·4-23·0] in the chemotherapy group). In the intention-to-treat wild-type population, there were significant improvements in median overall survival (18·6 months [95% CI 16·0-21·2] in the atezolizumab plus chemotherapy group and 13·9 months [12·0-18·7] in the chemotherapy group; stratified hazard ratio [HR] 0·79 [95% CI 0·64-0·98]; p=0·033) and median progression-free survival (7·0 months [95% CI 6·2-7·3] in the atezolizumab plus chemotherapy group and 5·5 months [4·4-5·9] in the chemotherapy group; stratified HR 0·64 [95% CI 0·54-0·77]; p<0·0001]). The most common grade 3 or worse treatment-related adverse events were neutropenia (152 [32%] of 473 in the atezolizumab plus chemotherapy group vs 65 [28%] of 232 in the chemotherapy group), anaemia (138 [29%] vs 47 [20%]), and decreased neutrophil count (57 [12%] vs 19 [8%]). Treatment-related serious adverse events were reported in 112 (24%) of 473 patients in the atezolizumab plus chemotherapy group and 30 (13%) of 232 patients in the chemotherapy group. Treatment-related (any treatment) deaths occurred in eight (2%) of 473 patients in the atezolizumab plus chemotherapy group and one (<1%) of 232 patients in the chemotherapy group. INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations. No new safety signals were identified. This study supports the benefit of atezolizumab, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer. FUNDING F. Hoffmann-La Roche.",2019,"INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","['patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations', 'Between April 16, 2015, and Feb 13, 2017', '724 patients were randomly assigned and 723 were included in the intention-to-treat population (one patient died before randomisation', 'Eligible patients were aged 18 years or older, and had histologically or cytologically confirmed stage IV non-squamous non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and received no previous chemotherapy for stage IV disease', '0·79', '131 centres across eight countries (the USA, Canada, Belgium, France, Germany, Italy, Spain, and Israel', 'patients with previously treated non-small-cell lung cancer', 'patients who received at least one dose of the study drug', 'metastatic non-squamous non-small-cell lung cancer (IMpower130', 'non-squamous non-small-cell lung cancer', 'group (240 patients in the intention-to-treat population and 228 patients in the intention-to-treat wild-type population']","['atezolizumab plus chemotherapy group (483 patients in the intention-to-treat population and 451 patients in the intention-to-treat wild-type population) or the chemotherapy', 'chemotherapy alone', 'chemotherapy (carboplatin [area under the curve 6 mg/mL per min every 3 weeks] plus nab-paclitaxel [100 mg/m 2 intravenously every week]) or chemotherapy alone', 'platinum-based chemotherapy', 'block [block size of six] with an interactive voice or web response system) to receive atezolizumab', 'carboplatin plus nab-paclitaxel chemotherapy', 'Atezolizumab', 'atezolizumab plus chemotherapy versus chemotherapy', 'atezolizumab', 'atezolizumab plus chemotherapy']","['hazard ratio [HR', 'anaemia', 'efficacy and safety', 'median progression-free survival', 'progression-free survival', 'investigator-assessed progression-free survival and overall survival', 'neutropenia', 'median overall survival', 'serious adverse events', 'overall survival', 'neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517866', 'cui_str': 'Seven hundred and twenty-three'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}]",724.0,0.387435,"INTERPRETATION IMpower130 showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as first-line treatment of patients with stage IV non-squamous non-small-cell lung cancer and no ALK or EGFR mutations.","[{'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Fort Myers, FL, USA.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Sarah Cannon Research Institute, Florida Cancer Specialists, Leesburg, FL, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Morabito', 'Affiliation': 'Thoracic Medical Oncology, National Cancer Institute, IRCCS Fondazione G. Pascale, Napoli, Italy.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Rittmeyer', 'Affiliation': 'Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Conter', 'Affiliation': 'Department of Medicine, William Osler Health System, Brampton, ON, Canada.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert Bosch Centrum für Tumorerkrankungen, Klinik Schillerhöhe, Stuttgart, Germany.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McCune', 'Affiliation': 'Northwest Georgia Oncology Centers, Marietta, GA, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mekhail', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Zer', 'Affiliation': 'Thoracic Oncology Unit, Rabin Medical Center, Tel Aviv University, Petah-Tikva, Israel.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sadiq', 'Affiliation': 'Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sandler', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Clinical Science, Genentech, South San Francisco, CA, USA; Nektar Therapeutics, San Francisco, CA, USA.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ochi Lohmann', 'Affiliation': 'PD Oncology, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Venice', 'Initials': 'V', 'LastName': 'Archer', 'Affiliation': 'PD Oncology, Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Lijia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kowanetz', 'Affiliation': 'Oncology Biomarker Development, Genentech, South San Francisco, CA, USA; Biotherapeutics, Inc., Redwood City, CA, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Cappuzzo', 'Affiliation': 'Department of Oncology and Hematology, AUSL Romagna, Ravenna, Italy. Electronic address: f.cappuzzo@gmail.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30167-6'] 1047,30181016,A mixed-effects location scale model for time-to-event data: A smoking behavior application.,"In general, mixed-effects location scale models (MELS) allow assessment of within-person and between-person variability with time-to-event data for outcomes that follow a normal or ordinal distribution. In this article, we extend the mixed-effects location scale model to time-to-event data in relation to smoking data. Better understanding of the time-graded within-person variability of factors involved in nicotine dependence can be helpful to researchers in their efforts to fine-tune smoking cessation programs. We illustrate the MELS model with data on time to first cigarette measured every day for 7 days in smokers randomized to two groups: a) those asked to keep smoking, or b) those asked to stop. Our results show that some individuals remain very stable in their time to first cigarette over the week, while others show variable patterns. The stable individuals smoked every day, did not smoke immediately upon waking, and were all in the group asked to keep smoking. Conversely, the variable individuals had at least one day during which they did not smoke, other days during which they smoked within the first 5 min of waking, and they were almost all in the group asked to quit smoking. These findings suggested that MELS have the potential to provide insights on how people try to stop smoking. More importantly, this model can be applied to other clinically important outcomes such as time to relapse in a range of cessation programs.",2019,"More importantly, this model can be applied to other clinically important outcomes such as time to relapse in a range of cessation programs.",['time-to-event data'],['MELS'],[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",[],[],,0.0152176,"More importantly, this model can be applied to other clinically important outcomes such as time to relapse in a range of cessation programs.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Courvoisier', 'Affiliation': 'Faculty of Medicine, University of Geneva, Switzerland. Electronic address: Delphine.Courvoisier@hcuge.ch.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Walls', 'Affiliation': 'Department of Psychology, University of Rhode Island, United States.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Cheval', 'Affiliation': 'Faculty of Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Biostatistics, University of Chicago, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.08.032'] 1048,31133457,Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis.,"Inpatient diabetes management of those on hemodialysis poses a major challenge. In a post hoc analysis of a randomized controlled clinical trial, we compared the efficacy of fully automated closed-loop insulin delivery vs. usual care in patients undergoing hemodialysis while in hospital. Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia. Thus, closed-loop insulin delivery offers a novel way to achieve effective and safe glucose control in this vulnerable patient population.",2019,"Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia.","['inpatients with type 2 diabetes receiving hemodialysis', 'patients undergoing hemodialysis while in hospital']","['conventional subcutaneous insulin therapy', 'fully automated closed-loop insulin delivery vs. usual care', 'Fully closed-loop insulin delivery']","['risk of hypoglycemia', 'proportion of time when a continuous glucose monitor']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",,0.0225244,"Compared to control patients receiving conventional subcutaneous insulin therapy, those patients receiving closed-loop insulin delivery significantly increased the proportion of time when a continuous glucose monitor was in the target range of 5.6-10.0 mmol/l by 37.6 percent without increasing the risk of hypoglycemia.","[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gubler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hood', 'Initials': 'H', 'LastName': 'Thabit', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Manchester University Hospitals NHS Foundation, Manchester Academic Health Science Centre, Manchester, UK; Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hartnell', 'Affiliation': 'Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Semmo', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Coll', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Clinical Nutrition & Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.'}]",Kidney international,['10.1016/j.kint.2019.03.006'] 1049,9659323,Digital radiology in skeletal trauma: assessment of casualty officers' performance.,"Radiographic images can now be produced without the requirement of film processing and development, and can be displayed rapidly on a computer monitor. We assessed junior doctors' performance in interpreting images from 25 patients being investigated for possible fracture and also compared the diagnostic abilities of casualty officers with those of radiology specialist registrars. For interpretation of images viewed at a workstation or as filmed laser images, respectively, sensitivities were 75% and 78%, and specificities were 65% and 76%. These differences were not significant. There was a tendency for radiology specialist registrars to be less specific when reviewing images at a workstation. The demonstration that there is no loss in diagnostic quality when casualty officers interpret fracture images in a purely digitally acquired and viewed format forms a robust basis for economic evaluation of the technology.",1998,We assessed junior doctors' performance in interpreting images from 25 patients being investigated for possible fracture and also compared the diagnostic abilities of casualty officers with those of radiology specialist registrars.,['25 patients being investigated for possible fracture and also compared the diagnostic abilities of casualty officers with those of radiology specialist registrars'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0579022', 'cui_str': 'Specialist registrar (occupation)'}]",[],[],,0.0455898,We assessed junior doctors' performance in interpreting images from 25 patients being investigated for possible fracture and also compared the diagnostic abilities of casualty officers with those of radiology specialist registrars.,"[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Gillard', 'Affiliation': ""University Department of Radiology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hubbard', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sherriff', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1050,12562974,Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery.,"Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.",2003,There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four.,"['patients undergoing elective hand surgery', '64 adults undergoing elective surgery for carpal tunnel syndrome', '62 patients could be included in the intention-to-treat analysis']","['Homeopathic arnica', 'homeopathic arnica 30C or 6C or placebo', 'placebo']","['Adverse events', 'pain', 'swelling (wrist circumference) and use of analgesic medication (patient diary', 'postoperative pain, bruising and swelling', 'Swelling and use of analgesic medication', 'pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0555881', 'cui_str': 'Arnica extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",64.0,0.76675,There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stevinson', 'Affiliation': 'Department of Complementary Medicine, University of Exeter, UK.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Devaraj', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fountain-Barber', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hawkins', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ernst', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1051,32410198,The Role of Skin Thickness in the Choice of a Rhinoplasty Technique for Thin-Skinned Patients: Analysis of Long-Term Results and Patient Satisfaction.,"INTRODUCTION This randomized controlled study aimed to analyse the long-term results of thin-skinned patients who underwent rhinoplasty. MATERIALS AND METHODS All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2 years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study. The patients were randomly divided into 4 groups as follows: group 1, camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum. Patients answered the Italian version of the FACE-Q rhinoplasty module. The Obagi skin pinch test was used to measure nasal skin thickness. We compared pre- and post-operative patient satisfaction with the appearance of their nose between the 4 patient groups by the Chi-squared test for unpaired data. Two plastic surgeons reviewed all the post-operative photographs of the study patients and rated the photographs on a scale of 1 to 5. RESULTS A total of 101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study. The mean patient age was 38.5 years. The mean follow-up time was 2.5 years. The differences between the preoperative and post-operative FACE-Q values for group 1 were significant (P < 0.01), whereas the differences between the preoperative and post-operative FACE-Q values for the other groups were not significant. The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01). Groups 2 and 4 underwent more secondary procedures than groups 1 and 3 (P < 0.01). The 2 reviewers determined that patient groups 1 and 3 obtained more satisfactory outcomes than groups 1 and 4 (P < 0.01). CONCLUSIONS This was the first randomized study to demonstrate that diced cartilage grafts used for thin-skinned patients was the best approach for obtaining a satisfactory long-term outcome and durable natural appearance. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"['All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2\xa0years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study', '101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study', 'thin-skinned patients who underwent rhinoplasty', 'mean patient age was 38.5\xa0years']","['diced cartilage grafts', 'camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum']","['preoperative and post-operative FACE-Q values', 'satisfactory outcomes', 'Skin Thickness', 'nasal skin thickness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0225213', 'cui_str': 'Temporal fascia structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",101.0,0.030166,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Panasiti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppola', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Russo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01763-6'] 1052,10730110,Effect of beer consumption on plasma magnesium: randomized comparison with mineral water.,"Moderate consumption of ethanol lowers mortality from coronary artery disease, and one of the possible mechanisms is an antiarrhythmic action. We therefore investigated the effect of a small daily dose of beer on plasma electrolytes. 52 men who seldom drank alcohol, clinically stable more than one year after coronary bypass surgery, were randomized to drink either 330 mL beer (containing about 20 g ethanol) or mineral water with similar potassium, magnesium, calcium and sodium content daily for 30 days. Plasma electrolytes and liver function indices, and also heart rate, blood pressure and weight, were measured before and after the trial period. The only significant before-and-after difference was in the group consuming beer, whose plasma magnesium rose from 0.89 (SD 0.01) to 0.98 (SD 0.02) mmol/L (P < 0.0025). This level of beer consumption did no obvious harm to liver function and its possibly beneficial effect on plasma magnesium deserves further investigation.",1998,"Plasma electrolytes and liver function indices, and also heart rate, blood pressure and weight, were measured before and after the trial period.","['52 men who seldom drank alcohol, clinically stable more than one year after coronary bypass surgery']","['drink either 330 mL beer (containing about 20 g ethanol) or mineral water with similar potassium, magnesium, calcium and sodium content daily for 30 days', 'ethanol', 'mineral water']","['Plasma electrolytes and liver function indices, and also heart rate, blood pressure and weight', 'plasma magnesium']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0556297', 'cui_str': 'Current drinker of alcohol (finding)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0858137', 'cui_str': 'Plasma magnesium'}]",,0.213747,"Plasma electrolytes and liver function indices, and also heart rate, blood pressure and weight, were measured before and after the trial period.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gorinstein', 'Affiliation': 'School of Pharmacy, Hebrew University of Jerusalem, Israel. gorin@cc.huji.ac.il'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zemser', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trakhtenberg', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caspi', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1053,10325874,Randomized double-blind placebo-controlled trial of homoeopathic 'proving' for Belladonna C30.,"Homoeopathic drug pictures are developed by recording the symptomatic effects of homoeopathic remedies given to healthy volunteers (a 'proving'). In a double-blind randomized controlled trial we tested the hypothesis that individuals using an infinitesimal dilution of Belladonna (thirtieth potency, C30) would record more true symptoms, on a questionnaire that contained both true and false Belladonna proving symptoms, than those receiving placebo. 60 volunteers entered the study and 47 completed data collection. We were unable to distinguish between Belladonna C30 and placebo using our primary outcome measure. For the secondary outcome measure we analysed the number of individuals who proved to the remedy according to our predefined criteria: 4 out of 19 proved in the Belladonna C30 group and 1 out of 27 in the placebo group (difference not statistically significant). This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.",1998,"This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.",['60 volunteers entered the study and 47 completed data collection'],"['Belladonna (thirtieth potency, C30', 'Belladonna C30 and placebo', 'placebo']",['number of individuals who proved to the remedy'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0301370', 'cui_str': 'atropa belladona extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]",60.0,0.662301,"This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goodyear', 'Affiliation': 'School of Medicine, University Medicine, University of Southampton, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lewith', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Low', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1054,31710974,"Nurses' just-in-time training for clinical deterioration: Development, implementation and evaluation.","BACKGROUND 'Just-in-time training' is an innovative approach to nursing education. It has demonstrated positive outcomes in other industries, such as manufacturing and aviation, but it has limited published application in the acute-care setting. OBJECTIVES We aimed to implement and evaluate a nursing 'just-in-time training' program for the recognition and response to patient deterioration. DESIGN To promote consistency, one Clinical Deterioration Educator provided education to nursing staff in both recognising the need for escalation and providing subsequent care for the deteriorating ward patient. Nurses' perception of the 'just-in-time training' program was determined using electronic questionnaire responses. Medical Emergency Team call prevalence and outcome data was compared before and after the program implementation for further evaluation. SETTING The 'just-in-time training' program was implemented in a 508-bed acute metropolitan private hospital over a 12-month period. Education was provided in general medical and surgical wards, not specialty areas. PARTICIPANTS Nurses received the just-in-time training based on their patients' perceived risk of deterioration, therefore, participants are not randomised. METHODS A quantitative research study investigated nurses' self-perceived confidence after receiving just-in-time training. Medical Emergency Team call frequency data was also examined to identify trends. RESULTS The 'just-in-time training' program consisted of 534 bedside nursing encounters over 12 months. During the study, the need for the educator to recommend that nurses escalate care reduced in prevalence from 20% to 5.5%. Questionnaire responses demonstrated a self-perceived confidence following intervention of 4.32/5.0. Medical Emergency Team call prevalence, per 1000 patient bed days, increased from 13.6 pre-intervention to 15.4 post-intervention. CONCLUSIONS Just-in-time training' can be effectively implemented to educate ward nursing staff in recognising and responding to the deteriorating patient. The program is well received by nursing staff and leads to high self-perceived confidence to recognise and appropriately care for a deteriorating patient.",2020,The program is well received by nursing staff and leads to high self-perceived confidence to recognise and appropriately care for a deteriorating patient.,"[""The 'just-in-time training' program was implemented in a 508-bed acute metropolitan private hospital over a 12-month period""]",[],"['Questionnaire responses', 'electronic questionnaire responses']","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]",534.0,0.0170153,The program is well received by nursing staff and leads to high self-perceived confidence to recognise and appropriately care for a deteriorating patient.,"[{'ForeName': 'Rick C', 'Initials': 'RC', 'LastName': 'Peebles', 'Affiliation': 'Clinical Education Department, Cabrini Health, 154 Wattletree Rd, Malvern 3144, Victoria, Australia. Electronic address: rpeebles@cabrini.com.au.'}, {'ForeName': 'Imogen K', 'Initials': 'IK', 'LastName': 'Nicholson', 'Affiliation': 'Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Australia.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Schlieff', 'Affiliation': 'Clinical Education Department, Cabrini Health, 154 Wattletree Rd, Malvern 3144, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Peat', 'Affiliation': 'Clinical Education Department, Cabrini Health, 154 Wattletree Rd, Malvern 3144, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Brewster', 'Affiliation': 'Cabrini Health, Victoria, Australia; Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Victoria, Australia.'}]",Nurse education today,['10.1016/j.nedt.2019.104265'] 1055,9068434,"Double-blind, placebo-controlled, randomized clinical trial of homoeopathic arnica C30 for pain and infection after total abdominal hysterectomy.","Homoeopathic potencies of arnica have been used for many years to aid postoperative recovery. The effects of arnica C30 on pain and postoperative recovery after total abdominal hysterectomy were evaluated in a double-blind, randomized, controlled study. Of 93 women entered into the study, 20 did not complete protocol treatment: nine were excluded because they failed to comply with the protocol, nine had their operations cancelled or changed within 24 h and two had to be withdrawn because of the recurrence of previously chronic painful conditions. Those who did not complete protocol treatment were equally divided between the arnica (nine patients) and placebo groups (11 patients). 73 patients completed the study, of whom 35 received placebo and 38 received arnica C30. The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated. We conclude that arnica in homoeopathic potency had no effect on postoperative recovery in the context of our study.",1997,"The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated.","['73 patients completed the study, of whom 35 received', 'after total abdominal hysterectomy', 'pain and infection after total abdominal hysterectomy', '93 women entered into the study, 20 did not complete protocol treatment: nine were excluded because they failed to comply with the protocol, nine had their operations cancelled or changed within 24 h and two had to be withdrawn because of the recurrence of previously chronic painful conditions']","['arnica C30', 'homoeopathic arnica C30', 'placebo']","['pain and postoperative recovery', 'postoperative recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205455', 'cui_str': '9'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0555881', 'cui_str': 'Arnica extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",93.0,0.495841,"The placebo group had a greater median age and the arnica group had slightly longer operations; nevertheless, no significant difference between the two groups could be demonstrated.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, University of Southampton, England.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mullee', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lewith', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1056,31758324,Effects of a nutrition intervention on acute and late bowel symptoms and health-related quality of life up to 24 months post radiotherapy in patients with prostate cancer: a multicentre randomised controlled trial.,"PURPOSE Radiotherapy to the prostate gland and pelvic lymph nodes may cause acute and late bowel symptoms and diminish quality of life. The aim was to study the effects of a nutrition intervention on bowel symptoms and health-related quality of life, compared with standard care. METHODS Patients were randomised to a nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet. Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods were assessed up to 24 months after radiotherapy completion. Multiple linear regression was used to analyse the effects of the nutrition intervention on bowel symptoms during the acute (up to 2 months post radiotherapy) and the late (7 to 24 months post radiotherapy) phase. RESULTS Most symptoms and functioning worsened during the acute phase, and improved during the late phase in both the intervention and standard care groups. The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029). However, these associations were clinically trivial or small. CONCLUSIONS The effect of the nutrition intervention related to dietary fibre and lactose on bowel symptoms from pelvic RT was small and inconclusive, although some minor and transient improvements were observed. The results do not support routine nutrition intervention of this type to reduce adverse effects from pelvic radiotherapy.",2020,"The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029).","['Patients', 'patients with prostate cancer']","['nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet', 'radiotherapy', 'nutrition intervention']","['bowel symptoms', 'bowel symptoms and health-related quality of life', 'acute and late bowel symptoms and health-related quality of life', 'loss of appetite', 'flatulence', 'Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods', 'blood in stools']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3661726', 'cui_str': 'Insoluble dietary fiber'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1321898', 'cui_str': 'Bloody stool'}]",,0.0473045,"The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Forslund', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden. marina.forslund@igp.uu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ottenblad', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Department of Clinical Oncology, Central Hospital, Karlstad, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nygren', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05182-5'] 1057,31148099,Association of nimodipine and choline alphoscerate in the treatment of cognitive impairment in patients with cerebral small vessel disease: study protocol for a randomized placebo-controlled trial-the CONIVaD trial.,"BACKGROUND Vascular cognitive impairment (VCI) is an extremely disabling condition that includes post-stroke dementia and VCI caused by cerebral small vessel disease (SVD). Currently, there is no approved treatment for this condition. Drugs active on the cholinergic pathway have been tested in VCI patients showing positive but limited efficacy. The calcium-antagonist nimodipine also showed some moderate positive effects in VCI patients. AIMS CONIVaD (choline alphoscerate and nimodipine in vascular dementia) is a pilot, single-center, double-blinded, randomized trial aimed to assess whether the association of choline alphoscerate and nimodipine is more effective than nimodipine alone in reducing cognitive decline in patients with SVD and mild-to-moderate cognitive impairment. METHODS All patients are evaluated at baseline and after 12 months with: (1) clinical, daily functions, quality of life, and mood assessment and (2) extensive neuropsychological evaluation. After the baseline evaluation, patients are randomly assigned to one of the two arms of treatment: (1) nimodipine 90 mg/die t.i.d plus placebo b.i.d and (2) nimodipine 90 mg t.i.d plus choline alphoscerate 1200 mg/die b.i.d. for a total of 12 months. The primary endpoint is cognitive decline, expressed as the loss of at least two points on the Montreal Cognitive Assessment at 12 months. Secondary endpoints include safety and tolerability, functional, quality of life, and neuropsychological measures. DISCUSSION CONIVaD study is the first randomized controlled trial to examine the cognitive efficacy of combined choline alphoscerate-nimodipine treatment in VCI patients. Results of this pilot study will serve as a methodological basis for other clinical controlled, multicentric, double-blinded, and randomized trials. TRIAL REGISTRATION Clinical Trial NCT03228498. Registered 25 July 2017.",2020,"All patients are evaluated at baseline and after 12 months with: (1) clinical, daily functions, quality of life, and mood assessment and (2) extensive neuropsychological evaluation.","['vascular dementia', 'VCI patients', 'patients with SVD and mild-to-moderate cognitive impairment', 'patients with cerebral small vessel disease']","['nimodipine and choline alphoscerate', 'placebo', 'nimodipine 90\xa0mg t.i.d plus choline', 'nimodipine 90\xa0mg/die t.i.d plus placebo', 'calcium-antagonist nimodipine', 'CONIVaD (choline alphoscerate and nimodipine', 'combined choline alphoscerate-nimodipine', 'nimodipine']","['cognitive decline, expressed as the loss of at least two points on the Montreal Cognitive Assessment', 'safety and tolerability, functional, quality of life, and neuropsychological measures', 'cognitive impairment', 'daily functions, quality of life, and mood assessment and (2) extensive neuropsychological evaluation', 'cognitive efficacy', 'cognitive decline']","[{'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C2733158', 'cui_str': 'Cerebral Microangiopathies'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0017889', 'cui_str': 'Glycerylphosphorylcholine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C3496286'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}]",,0.677491,"All patients are evaluated at baseline and after 12 months with: (1) clinical, daily functions, quality of life, and mood assessment and (2) extensive neuropsychological evaluation.","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Salvadori', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Poggesi', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Donnini', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Rinnoci', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Chiti', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Squitieri', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tudisco', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Fierini', 'Affiliation': 'Psychiatry Unit, Department of Health Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Melone', 'Affiliation': 'NEUROFARBA Department, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pescini', 'Affiliation': 'Stroke Unit, Emergency Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Pantoni', 'Affiliation': ""Department of Biomedical and Clinical Sciences, 'L. Sacco' Hospital, University of Milan, Via Giovanni Battista Grassi 74, 20157, Milan, Italy. leonardo.pantoni@unimi.it.""}]",Aging clinical and experimental research,['10.1007/s40520-019-01229-z'] 1058,31120533,Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.,"Importance Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus. Objective To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life. Design, Setting, and Participants A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat. Interventions Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC. Main Outcomes and Measures The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS). Results Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%). Conclusions and Relevance There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus. Trial Registration ClinicalTrials.gov identifier: NCT01177137.",2019,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","['151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years', ""August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus""]","['Tinnitus Retraining Therapy vs Standard of Care', 'TRT', 'placebo', 'tinnitus-specific educational counseling (TC) and sound therapy (ST', 'TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.\nMain Outcomes and Measures', 'Tinnitus retraining therapy (TRT', 'partial TRT']","['TQ score', 'TQ scores', 'mean change on the Tinnitus Questionnaire (TQ', 'changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS', 'TQ, TFI, or THI total scores', 'quality of life', 'Tinnitus-Related Quality of Life', 'partial TRT']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",44.0,0.343141,"Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, University of Alabama, Tuscaloosa.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.0821'] 1059,31111801,Size matters: the importance of particle size in a newly developed injectable formulation for the treatment of schizophrenia.,"One of the challenges with initiating long-acting injectable (LAI) antipsychotic regimens is achieving relevant drug levels quickly. After first injection of the LAI antipsychotic aripiprazole lauroxil (AL), the lag to reaching relevant plasma aripiprazole levels was initially addressed using supplemental oral aripiprazole for 21 days. A 1-day AL initiation regimen using a NanoCrystal® Dispersion formulation of AL (ALNCD; Aristada Initio®) combined with a single 30 mg dose of oral aripiprazole has been developed as an alternative approach. We compared the 1-day AL initiation regimen (ALNCD + 30 mg oral aripiprazole for 1 day) with the 21-day AL initiation regimen (AL + 15 mg/day of oral aripiprazole for 21 days) using kinetic modeling. Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen. Each component of the 1-day AL initiation regimen (30 mg oral aripiprazole, ALNCD, and AL) contributes to aripiprazole plasma levels at different times, with oral aripiprazole predominating in the first week, then ALNCD and AL over time. In a double-blind, placebo-controlled, phase 1 study in patients with schizophrenia, the 1-day initiation regimen resulted in rapid achievement of relevant plasma aripiprazole levels comparable to those from the 21-day initiation regimen. Safety and tolerability of the 1-day regimen were consistent with the known profile of aripiprazole. Each part of the 1-day initiation regimen, together with AL, is necessary for continuous aripiprazole exposure from treatment initiation until the next regularly scheduled AL injection is administered.",2020,Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen.,['patients with schizophrenia'],"['placebo', '1-day AL initiation regimen (ALNCD + 30 mg oral aripiprazole', 'LAI antipsychotic aripiprazole lauroxil (AL', 'initiating long-acting injectable (LAI) antipsychotic regimens', 'aripiprazole']","['rapid achievement of relevant plasma aripiprazole levels', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0443021', 'cui_str': 'Lai (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0147806,Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, Texas Tech University School of Medicine-Permian Basin, Midland, TX, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wehr', 'Affiliation': 'Clinical Pharmacology, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Rege', 'Affiliation': 'Clinical Pharmacology, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Moltke', 'Affiliation': 'Clinical Development, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Medical Affairs, Alkermes, Inc., Waltham, MA, USA.'}]",CNS spectrums,['10.1017/S1092852919000816'] 1060,31140569,"Home-Based, Adaptive Cognitive Training for Cognitively Normal Older adults: Initial Efficacy Trial.","OBJECTIVES We examined whether a home-based, adaptive cognitive training (CT) program would lead to cognitive performance changes on a neuropsychological test battery in cognitively normal older adults. METHOD Sixty-eight older adults (age = 70.0, SD = 3.74) were randomly assigned to either CT or an active control group (AC, casual computer games). Participants were instructed to train on their assigned programs for 42 min per day, 5 days per week, over 10 weeks (35 hr of total program usage). Participants completed tests of processing speed, working memory, and executive control before and after 10 weeks of training. RESULTS Training groups did not differ in performance before training. After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains. DISCUSSION Our results show that a limited dose of home-based CT can drive cognitive improvements as measured with neuropsychological test battery, suggesting potential cognitive health maintenance implications for cognitively normal older adults.",2020,"After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains. ","['Healthy Older Adults', 'Sixty-eight older adults (age = 70.0, SD=3.74', 'cognitively normal older adults']","['Home-Based, Adaptive Cognitive Training', 'home-based, adaptive cognitive training program', 'cognitive training (CT) or an active control group (AC, casual computer games', 'home-based cognitive training']","['processing speed, working memory, and executive control', 'overall cognitive composite score, driven by processing speed and working memory domains']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",68.0,0.0209864,"After training, CT participants out-performed AC participants in the overall cognitive composite score, driven by processing speed and working memory domains. ","[{'ForeName': 'Hyun Kyu', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Kent', 'Affiliation': 'Interdisciplinary Graduate Program in Neuroscience, University of Iowa, Iowa.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wendel', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa.'}, {'ForeName': 'Fredric D', 'Initials': 'FD', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Health Management and Policy, College of Public Health, University of Iowa, Iowa.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Foster', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Iowa, Iowa.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Merzenich', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, California.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Voss', 'Affiliation': 'Interdisciplinary Graduate Program in Neuroscience, University of Iowa, Iowa.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz073'] 1061,31746075,Behavioral couples therapy versus cognitive behavioral therapy for problem gambling: a randomized controlled trial.,,2020,"The outcomes of both gambler groups improved, and differences between the groups were not statistically significant:","['Stockholm, Sweden', 'gamblers were on average 35.6 years old and 18.4% were female', 'Problem Gambling', 'A total of 136 problem gamblers and 136 CSOs were included in the study: 68 gamblers and 68 CSOs for each treatment condition']","['Internet-based behavioral couples therapy and cognitive behavioral therapy', 'Behavioral Couples Therapy vs. Cognitive Behavioral Therapy', 'cognitive behavioral therapy (CBT', 'behavioral couples therapy (BCT) and CBT']","['CSOs', 'Time-Line Follow-Back for Gambling (TLFB-G), and the NORC Diagnostic Screen for Gambling Problems (NODS) for problem gamblers, corresponding to DSM-IV criteria for Pathological Gambling', 'Patient Health Questionnaire-9 (PHQ-9), The Generalized Anxiety Disorder 7-item scale (GAD-7), The Relation Assessment Scale Generic (RAS-G), The Alcohol Use Disorders Identification Test (AUDIT), The Inventory of Consequences of Gambling for the Gambler and CSO (ICS), and adherence to treatment for both the problem gambler and the CSO']","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302822', 'cui_str': 'Couples Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0451543', 'cui_str': 'Time line follow back (assessment scale)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030662', 'cui_str': 'Gambling, Pathologic'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",136.0,0.0941086,"The outcomes of both gambler groups improved, and differences between the groups were not statistically significant:","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Hellner', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14900'] 1062,31096843,Effects of a web-based expert support self-management program (WEST) for women with breast cancer: A randomized controlled trial.,"INTRODUCTION This study was a randomized controlled trial that examined the effects of a web-based expert support self-management program (WEST) on metabolic syndrome risk factors and self-efficacy among Korean women with breast cancer. METHODS Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors. WEST is based on the self-efficacy theory and is a self-health management program consisting of a web-based program, DIETEX (which entails keeping a health diary, identifying a lifestyle type, inputting personal health information), and expert support. WEST was provided to the experimental group once a week for 24 weeks. Metabolic syndrome risk factors and self-efficacy of the experimental and control groups were examined pre-intervention and at 12 and 24 weeks after intervention. RESULTS The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p  = 0.019, p  = 0.025, and p  = 0.038, respectively). DISCUSSION The present study can provide basic data for the development and application of interventions for women with breast cancer in the future. Additionally, we propose that WEST be included in the treatment process to complement the intervention of medical personnel for improving metabolic risk factors in women with breast cancer.",2019,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively). ","['women with breast cancer', 'Participants were 60 women with breast cancer (30 participants each in both the experimental and control groups) who also had metabolic risk factors', 'women with breast cancer in the future', 'Korean women with breast cancer']",['web-based expert support self-management program (WEST'],"['metabolic syndrome risk factors and self-efficacy', 'body fat, body fat percentage, and waist circumference', 'Metabolic syndrome risk factors and self-efficacy', 'metabolic risk factors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",60.0,0.0315839,"The decreases in body fat, body fat percentage, and waist circumference were greater in the experimental group than in the control group at 24 weeks ( p = 0.019, p = 0.025, and p = 0.038, respectively). ","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, University of Ulsan, The Republic of Korea.'}, {'ForeName': 'Hee-Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, The Catholic University of Korea, Seoul, The Republic of Korea.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19850386'] 1063,31106491,Newborn physical condition and breastfeeding behaviours: Secondary outcomes of a cluster-randomized trial of prenatal lipid-based nutrient supplements in Bangladesh.,"Prenatal nutritional supplements may improve birth outcomes. This study aims to examine the effect of prenatal lipid-based nutrient supplements (LNS), compared with iron and folic acid (IFA), on general newborn physical condition and feeding behaviours. We conducted a cluster-randomized effectiveness trial that enrolled 4,011 pregnant women at ≤20 gestational weeks. LNS and IFA were provided to women in 48 and 16 clusters, respectively, for daily consumption until delivery. We collected data on household socio-economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72 hr of delivery. We analysed intervention effects on these secondary outcomes using mixed models with analysis of covariance for continuous outcomes and logistic regression for dichotomous outcomes. Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr. If the mother perceived her infant to be healthy, EIBF was more likely (OR [95% CI]: 2.08 [1.46, 2.97]) and frequency of breastfeeding in the first 24 hr was greater (mean difference [95% CI]: 3.0 [1.91, 4.01]), but there was no difference in exclusive breastfeeding in the first 24 hr. Newborn condition and early breastfeeding practices were not affected by giving mothers prenatal LNS versus IFA. However, early breastfeeding practices were related to maternal perception of her newborn's condition. Thus, interventions to improve breastfeeding practices for newborns with poorer perceived health status may be useful.",2019,"Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr.","['Newborn physical condition and breastfeeding behaviours', 'enrolled 4,011 pregnant women at ≤20 gestational weeks', 'general newborn physical condition and feeding behaviours', 'Bangladesh']","['prenatal lipid-based nutrient supplements (LNS), compared with iron and folic acid (IFA', 'Prenatal nutritional supplements', 'prenatal lipid-based nutrient supplements']","['frequency of breastfeeding', 'household socio-economic, food insecurity, and maternal characteristics during early pregnancy and on newborn condition and feeding within 72\xa0hr of delivery', 'birth outcomes', 'Newborn condition and early breastfeeding practices', 'exclusive breastfeeding', ""maternal perception of her newborn's condition"", ""newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding""]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C0566398', 'cui_str': 'Does suckle (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",4011.0,0.0875295,"Among 3,664 live births, intervention groups did not differ in newborn response, mother's rating of the general condition of her newborn, early initiation of breastfeeding (EIBF), suckling ability, or frequency and exclusivity of breastfeeding in the first 24 hr.","[{'ForeName': 'Md Barkat', 'Initials': 'MB', 'LastName': 'Ullah', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Md Showkat A', 'Initials': 'MSA', 'LastName': 'Khan', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Zakia', 'Initials': 'Z', 'LastName': 'Siddiqui', 'Affiliation': 'Health System and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Mokbul', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Center for Non-communicable Disease and Nutrition, James P. Grant School of Public Health, BRAC University, Dhaka, Bangladesh.'}, {'ForeName': 'Rina Rani', 'Initials': 'RR', 'LastName': 'Paul', 'Affiliation': 'Division of Health, CARE Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, USA.'}]",Maternal & child nutrition,['10.1111/mcn.12844'] 1064,31530666,Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial.,"OBJECTIVE Efficacy and safety of the glucagon-like peptide 1 (GLP-1) analog oral semaglutide and the sodium-glucose cotransporter 2 inhibitor empagliflozin were compared in patients with type 2 diabetes uncontrolled on metformin. RESEARCH DESIGN AND METHODS Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg ( n = 412) or empagliflozin 25 mg ( n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA 1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized patients. RESULTS Four hundred (97.1%) patients in the oral semaglutide group and 387 (94.4%) in the empagliflozin group completed the trial. Oral semaglutide provided superior reductions in HbA 1c versus empagliflozin at week 26 (treatment policy -1.3% vs. -0.9% [-14 vs. -9 mmol/mol], estimated treatment difference [ETD] -0.4% [95% CI -0.6, -0.3] [-5 mmol/mol (-6, -3)]; P < 0.0001). The treatment difference in HbA 1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P < 0.0001) and at week 52 for both estimands ( P < 0.0001). Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114). Gastrointestinal adverse events were more common with oral semaglutide. CONCLUSIONS Oral semaglutide was superior to empagliflozin in reducing HbA 1c but not body weight at 26 weeks in patients with type 2 diabetes uncontrolled on metformin. At week 52, HbA 1c and body weight (trial product estimand) were significantly reduced versus empagliflozin. Oral semaglutide was well tolerated within the established safety profile of GLP-1 receptor agonists.",2019,"Oral semaglutide provided superior reductions in HbA 1c versus empagliflozin at week 26 (treatment policy: -1.3% vs. -0.9% [-14 vs. -9 mmol/mol]; estimated treatment difference [ETD]: -0.4%, 95% CI -0.6, -0.3 [","['Patients', 'Patients with Type 2 Diabetes Uncontrolled on', 'patients with type 2 diabetes uncontrolled on metformin', 'patients with type 2 diabetes uncontrolled on']","['Oral Semaglutide versus Empagliflozin', 'Metformin', 'GLP-1 analog, oral semaglutide, and the SGLT-2 inhibitor, empagliflozin', 'metformin', 'daily open-label treatment with oral semaglutide 14 mg ( n = 412) or empagliflozin', 'empagliflozin']","['HbA 1c (primary) and body weight (confirmatory secondary', 'oral semaglutide', 'Superior weight loss', 'Gastrointestinal adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",400.0,0.0679674,"Oral semaglutide provided superior reductions in HbA 1c versus empagliflozin at week 26 (treatment policy: -1.3% vs. -0.9% [-14 vs. -9 mmol/mol]; estimated treatment difference [ETD]: -0.4%, 95% CI -0.6, -0.3 [","[{'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants, Rockville, MD hrodbard@comcast.net.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Canani', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Chaicharn', 'Initials': 'C', 'LastName': 'Deerochanawong', 'Affiliation': 'Rajavithi Hospital, Rangsit Medical School, Bangkok, Thailand.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Gumprecht', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Søren Østergaard', 'Initials': 'SØ', 'LastName': 'Lindberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Departments of Internal Medicine and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Anette Luther', 'Initials': 'AL', 'LastName': 'Søndergaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne Bach', 'Initials': 'MB', 'LastName': 'Treppendahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Montanya', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0883'] 1065,31100756,"Importance of Temperament in Individualized Homeopathic Prescription: Evaluation by an Open, Randomized, Pilot Trial.","BACKGROUND The importance of temperament in the selection of an individualized homeopathic medicine has not been evaluated systematically. The current study explored this under-researched area. MATERIALS AND METHODS A prospective, open, randomized (1:1), two parallel arms, pilot trial was performed on patients suffering from various chronic diseases. Each patient's temperament was assessed using a newly developed ""temperament diagnostic questionnaire"". Outcome measures were health status using the EQ-5D-5L questionnaire and a visual analog scale (VAS) of patient's self-rated health, measured at baseline and at 3 months. Homeopathic medicines were prescribed on the basis of individualization, randomly with or without accounting for individual temperament, and patients grouped accordingly (temperament(+) and temperament(-)). Baseline comparability of the two groups was checked, followed by analysis of group differences. A p- value < 0.01 was considered as statistically significant. RESULTS Fifty protocol-compliant patients were analyzed. The two groups were comparable at baseline. Over 3 months of intervention, there was significant improvement ( p  < 0.01) in each group. Though improvement in the EQ-5D-5L score was greater in the temperament(+) group (mean difference, 2.4; 95% confidence interval [CI], 0.2 to 4.5), the change did not achieve the threshold for statistical significance ( p  = 0.029). Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4; p  = 0.004). CONCLUSION Considering temperament as a key element of individualized prescription may enhance health improvement from homeopathic treatment in chronic diseases. Independently replicated rigorous trials with validated scales are warranted. TRIAL REGISTRATION CTRI/2018/03/012433.",2019,"Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4; p  = 0.004). ",['patients suffering from various chronic diseases'],['Homeopathic medicines'],"['VAS score', 'EQ-5D-5L score', 'temperament diagnostic questionnaire', ""health status using the EQ-5D-5L questionnaire and a visual analog scale (VAS) of patient's self-rated health""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.140102,"Improvement in VAS score was significantly greater in the temperament(+) group than in temperament(-) patients (mean difference, 15.2; 95% CI, 4.9 to 25.4; p  = 0.004). ","[{'ForeName': 'Najne', 'Initials': 'N', 'LastName': 'Sultana', 'Affiliation': 'Department of Repertory, National Institute of Homoeopathy, Kolkata, West Bengal, India.'}, {'ForeName': 'Amitava', 'Initials': 'A', 'LastName': 'Samanta', 'Affiliation': 'Department of Repertory, National Institute of Homoeopathy, Kolkata, West Bengal, India.'}, {'ForeName': 'Munmun', 'Initials': 'M', 'LastName': 'Koley', 'Affiliation': 'Independent Researcher, Hooghly, West Bengal, India.'}, {'ForeName': 'Subhranil', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Independent Researcher, Howrah, West Bengal, India.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0039-1685142'] 1066,31722404,Analgesic Effects of Directed Repetitive Transcranial Magnetic Stimulation in Acute Neuropathic Pain After Spinal Cord Injury.,"OBJECTIVES Central neuropathic pain (CNP) often appears following spinal cord injury (SCI), but current treatments are not always successful. In this study, we evaluated the analgesic effects of repetitive transcranial magnetic stimulation (rTMS) applied over the hand area of the motor cortex in patients with acute CNP after SCI. METHODS A total of 48 patients with complete or incomplete SCI and acute CNP participated in this study and were randomized to receive either rTMS (10 Hz, 1,500 stimuli; N = 24) or a sham intervention (N = 24) for three weeks. The numeric rating scale (NRS) and Short-Form McGill Pain Questionnaire-2 (Chinese Edition; SF-MPQ-2-CN) were analyzed to assess the degree of pain. Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) were collected to explore expression influenced by rTMS. Motor-evoked potential (MEP) latency and maximal amplitude were measured to determine neurophysiological changes. The assessments were carried out at baseline (T0), three days (T1), one week (T2), two weeks (T3), and three weeks (T4) after onset of treatment. RESULTS The analysis showed significant treatment-time interactions for the quality and intensity of pain, as measured by NRS (P < 0.001, η2 = 0.441) and SF-MPQ-2 (P < 0.001, η2 = 0.590). Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment. In addition, the serum levels of BDNF and NGF were significantly higher in the treated group after three weeks (P = 0.015, Cohen's d = 0.539; P = 0.009, Cohen's d = 0.580), and the MEP amplitude increased by 109.59% (P = 0.033, Cohen's d = 0.464). CONCLUSIONS These findings indicate that 10 Hz rTMS over the hand area of the motor cortex could alleviate acute CNP in the early phase of SCI and could enhance MEP parameters and modulate BDNF and NGF secretion.",2020,"Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment.",['patients with acute CNP after SCI.\nMETHODS\n\n\nA total of 48 patients with complete or incomplete SCI and acute CNP participated in this study'],"['Directed Repetitive Transcranial Magnetic Stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['degree of pain', 'Acute Neuropathic Pain', 'serum levels of BDNF and NGF', 'SF-MPQ-2', 'MEP parameters and modulate BDNF and NGF secretion', 'Motor-evoked potential (MEP) latency and maximal amplitude', 'NRS and SF-MPQ2-CN scores', 'numeric rating scale (NRS) and Short-Form McGill Pain Questionnaire-2 (Chinese Edition; SF-MPQ-2-CN', 'quality and intensity of pain', 'MEP amplitude', 'Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",1500.0,0.188542,"Compared with the sham group, the NRS and SF-MPQ2-CN scores were significantly lower on the third day (P < 0.001, Cohen's d = 1.135; P = 0.006, Cohen's d = 0.616) and after one week (P < 0.001, Cohen's d = 0.846; P = 0.012, Cohen's d = 0.557) of treatment.","[{'ForeName': 'Chen-Guang', 'Initials': 'CG', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Ju', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Mou', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""Department of Rehabilitation Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz290'] 1067,31563363,"Effects of Kinesio Taping on postural balance in patients with low back pain, a randomized controlled trial.","PURPOSE to identify postural balance changes in subjects with low back pain after the application of Kinesio Taping, which is then compared to a no treatment control group, using baropodometric evaluation. METHODS This randomized controlled trial was carried out on 50 individuals (both sexes) with chronic low back pain. They were then randomized into two groups: an experimental group - EG (treated with Kinesio Taping in the lumbar region) and a control group - CG (no intervention). Both groups underwent a baropodometric evaluation (mean plantar pressure, peak plantar pressure, plantar surface, mass distribution on right foot and left foot, mass distribution on forefoot and rear foot and base width) at four different moments: pre-intervention, 10 minutes, 48 hours, and 10 days after the intervention on the EG. The level of statistical significance was established at 5%. RESULTS Significant changes were observed in the EG compared to the CG. In the EG, peak pressure reduced on both right and left foot after Kinesio Taping application; the right base width was reduced, and the mass distribution between the forefoot and the rear foot normalized towards the ideal 50% distribution. These changes happened 48 hours after the Kinesio Taping application, with effects lasting up to 10 days. CONCLUSION The use of Kinesio Taping in the lumbar region of subjects with chronic low back pain improved postural balance. This is proved by changes in peak plantar pressure, plantar surface, and mass distribution 48 h after Kinesio Taping application, with effects lasting up to 10 days.",2019,"In the EG, peak pressure reduced on both right and left foot after Kinesio Taping application; the right base width was reduced, and the mass distribution between the forefoot and the rear foot normalized towards the ideal 50% distribution.","['patients with low back pain', 'subjects with low back pain after the application of', 'subjects with chronic low back pain improved postural balance', '50 individuals (both sexes) with chronic low back pain']","['experimental group - EG (treated with Kinesio Taping in the lumbar region) and a control group - CG (no intervention', 'Kinesio Taping']","['peak pressure', 'baropodometric evaluation (mean plantar pressure, peak plantar pressure, plantar surface, mass distribution on right foot and left foot, mass distribution on forefoot and rear foot and base width', 'postural balance', 'peak plantar pressure, plantar surface']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0230460', 'cui_str': 'Structure of right foot'}, {'cui': 'C0230461', 'cui_str': 'Structure of left foot'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}]",50.0,0.0408455,"In the EG, peak pressure reduced on both right and left foot after Kinesio Taping application; the right base width was reduced, and the mass distribution between the forefoot and the rear foot normalized towards the ideal 50% distribution.","[{'ForeName': 'Rafaella Stradiotto', 'Initials': 'RS', 'LastName': 'Bernardelli', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil. Electronic address: rafaella.bernardelli@gmail.com.'}, {'ForeName': 'Eduardo Mendonça', 'Initials': 'EM', 'LastName': 'Scheeren', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Alonso Romero', 'Initials': 'AR', 'LastName': 'Fuentes Filho', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Paty Aparecida', 'Initials': 'PA', 'LastName': 'Pereira', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Munir Antonio', 'Initials': 'MA', 'LastName': 'Gariba', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Auristela Duarte de Lima', 'Initials': 'ADL', 'LastName': 'Moser', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Gerson Linck', 'Initials': 'GL', 'LastName': 'Bichinho', 'Affiliation': 'Postgraduate Program in Health Technology of Pontifical Catholic University of Paraná, Curitiba, Paraná, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.002'] 1068,31563369,Roller massage: Comparison of three different surface type pattern foam rollers on passive knee range of motion and pain perception.,"INTRODUCTION Roller massage with a foam roller has become a common intervention. To date, no studies have examined the therapeutic effects of different surface type rollers. The purpose of this study was to measure the therapeutic effects of three different surface type pattern foam rollers with the same density on passive knee joint range of motion (ROM) and pressure pain threshold (PPT) of the quadriceps. METHODS This pre-test, post-test randomized controlled trial was conducted in a university laboratory. Thirty-six participants (M = 22, F = 14; mean age = 25.20 ± 4.44 years) were randomly assigned to three groups: (1) smooth surface, (2) multilevel surface, and (3) GRID surface. The intervention was a 2-min rolling session. Outcomes included knee ROM and PPT. RESULTS Between group comparisons revealed a statistically significant post-intervention difference between the three rollers for knee ROM (p = 0.04) and PPT (p < 0.001). Within group comparison for ROM revealed a 3-degree (p = 0.015) increase for the smooth, a 5-degree (p < 0.001) increase for the multilevel, and a 6-degree (p < 0.001) increase for the GRID surface roller. For PPT, there was an increase of 14 kPa (p = 0.562) for the smooth, 179 kPa (p < 0.001) for the multilevel, and 182 kPa (p < 0.001) for the GRID. CONCLUSION The GRID and multilevel surface rollers produced greater immediate post-intervention effects than the smooth roller. The therapeutic effects of the GRID and multilevel rollers may be due to the surface architecture. These rollers may provide a greater deformation of the tissues which creates a local mechanical and global neurophysiological effect.",2019,"Within group comparison for ROM revealed a 3-degree (p = 0.015) increase for the smooth, a 5-degree (p < 0.001) increase for the multilevel, and a 6-degree (p < 0.001) increase for the GRID surface roller.","['Thirty-six participants (M\u202f=\u202f22, F\u202f=\u202f14; mean age\u202f=\u202f25.20\u202f±\u202f4.44 years']",[],"['knee ROM', 'passive knee joint range of motion (ROM) and pressure pain threshold (PPT) of the quadriceps', 'knee ROM and PPT', 'passive knee range of motion and pain perception']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}]",36.0,0.0431188,"Within group comparison for ROM revealed a 3-degree (p = 0.015) increase for the smooth, a 5-degree (p < 0.001) increase for the multilevel, and a 6-degree (p < 0.001) increase for the GRID surface roller.","[{'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Cheatham', 'Affiliation': 'California State University Dominguez Hills, 1000 E. Victoria Street, Carson, CA, 90747, USA. Electronic address: scheatham@csudh.edu.'}, {'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Stull', 'Affiliation': 'National Academy of Sports Medicine, 1750 E. Northrop Blvd, Chandler, AZ, 85286, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.002'] 1069,31563372,Quadriceps foam rolling and rolling massage increases hip flexion and extension passive range-of-motion.,"Increases in joint range-of-motion may be beneficial for improving performance and reducing injury risk. This study investigated the effects of different self-massage volumes and modalities on passive hip range-of-motion. Twenty-five recreationally resistance-trained men performed four experimental protocols using a counterbalanced, randomized, and within-subjects design; foam rolling (FR) or roller massage (RM) for 60 or 120-s. Passive hip flexion and extension range-of-motion were measured in a counterbalanced and randomized order via manual goniometry before self-massage (baseline) and immediately, 10-, 20-, and 30-min following each self-massage intervention. Following FR or RM of quadriceps, there was an increase in hip flexion range-of-motion at Post-0 (FR: Δ = 19.28°; RM: Δ = 14.96°), Post-10 (FR: Δ = 13.03°; RM: Δ = 10.40°), and Post-20 (FR: Δ = 6.00°; RM: Δ = 4.64°) for all protocols, but these did not exceed the minimum detectable change at Post-10 for RM60 and RM120, and Post-20 for FR60, FR120, RM60, and RM120. Similarly, hip extension range-of-motion increased at Post-0 (FR: Δ = 8.56°; RM: Δ = 6.56°), Post-10 (FR: Δ = 4.64°; RM: Δ = 3.92°), and Post-20 (FR: Δ = 2.80°; RM: Δ = 1.92°), but did not exceed the minimum detectable change at Post-10 for FR60, RM60, and RM120, and Post-20 for FR60, FR120, RM60, and RM120. In conclusion, both FR and RM increased hip range-of-motion but larger volumes (120- vs. 60-second) and FR produced the greatest increases. These findings have implications for self-massage prescription and implementation, in both rehabilitation and athletic populations.",2019,"Following FR or RM of quadriceps, there was an increase in hip flexion range-of-motion at Post-0 (FR:",['Twenty-five recreationally resistance-trained men'],"['foam rolling (FR) or roller massage (RM', 'Quadriceps foam rolling and rolling massage', 'Post-0 (FR']","['minimum detectable change at Post-10 for FR60, RM60, and RM120, and Post-20 for FR60, FR120, RM60, and RM120', 'hip flexion and extension passive range-of-motion', 'hip flexion range-of-motion at Post-0 (FR', 'hip extension range-of-motion', 'minimum detectable change at Post-10 for RM60 and RM120, and Post-20 for FR60, FR120, RM60, and RM120', 'Passive hip flexion and extension range-of-motion']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C1211818', 'cui_str': 'Rollers'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",,0.059376,"Following FR or RM of quadriceps, there was an increase in hip flexion range-of-motion at Post-0 (FR:","[{'ForeName': 'Estêvão Rios', 'Initials': 'ER', 'LastName': 'Monteiro', 'Affiliation': 'Department of Gymnastics, School of Physical Education and Sports, Federal University of Rio De Janeiro, Rio de Janeiro, Brazil. Electronic address: profestevaomonteiro@gmail.com.'}, {'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'da Silva Novaes', 'Affiliation': 'Department of Gymnastics, School of Physical Education and Sports, Federal University of Rio De Janeiro, Rio de Janeiro, Brazil; College of Physical Education and Sports, Federal University of Juiz de Fora, Minas Gerais, Brazil. Electronic address: jsnovaes@terra.com.br.'}, {'ForeName': 'Mark Tyler', 'Initials': 'MT', 'LastName': 'Cavanaugh', 'Affiliation': 'School of Human Kinetics and Recreation, Memorial University of Newfoundland, Canada. Electronic address: mtc118@mun.ca.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Hoogenboom', 'Affiliation': 'Grand Valley State University, Grand Rapids, MI, USA. Electronic address: hogenbb@gvsu.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'School of Sport, Health, and Social Science, Southampton Solent University, UK; Ukactive Research Institute, London, UK. Electronic address: james.steele@solent.ac.uk.'}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Vingren', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion and Recreation, University of North Texas, USA. Electronic address: jakob.vingren@unt.edu.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Škarabot', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle Upon Tyne, UK. Electronic address: jakob.skarabot@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.008'] 1070,30517724,"Vitamin A Supplementation during Pregnancy Enhances Pandemic H1N1 Vaccine Response in Mothers, but Enhancement of Transplacental Antibody Transfer May Depend on When Mothers Are Vaccinated during Pregnancy.","Background In the growing embryo, the vitamin A requirement is tightly regulated. Maternal vitamin A deficiency during pregnancy may alter maternal immune function to accommodate the fetus. Objective Our primary objective was to determine the effect of oral vitamin A supplementation (VAS) during pregnancy and until 6 mo postpartum on pandemic H1N1-vaccine responses in mothers and their infants at 6 mo of age. Methods In this randomized controlled clinical trial, pregnant women (n = 112) during the second trimester (mean ± SD: 14 ± 1 wk) were assigned to receive either an oral dose of 10,000 IU vitamin A or placebo weekly until 6 mo postpartum. During the third trimester, mothers received a single dose of inactivated pandemic H1N1-influenza vaccine. Hemagglutination-inhibition (HAI) titer was measured in cord, infant, and maternal blood samples. Multivariate regressions with adjustments were used for data analysis. Results Seventy-six percent of women had low plasma retinol concentrations (<1.05 μmol/L) in their second trimester. VAS of mothers increased vitamin A concentrations in cord blood by 21.4% and in colostrum by 40.7%. At 6 mo postpartum, women in the vitamin A group had 38.7% higher HAI titers and a higher proportion of HAI titer of ≥1:40 of the cutoff compared with the placebo group. A total of 54.5% of infants had an HAI titer ≥1:40 at 6 mo of age, but there was no difference in HAI titer in infants between groups. Overall, HAI in cord blood did not differ between groups, but in the placebo group, cord blood HAI was negatively associated with maternal ""vaccination-to-delivery intervals"" (rs = -0.401; P = 0.5), and maternal VAS increased cord blood HAI 6-fold if antenatal immunization was administered ≥10 wk before delivery. Conclusions In a community with low vitamin A status, weekly maternal VAS during pregnancy and postpartum increases the breast-milk vitamin A concentration and enhances prenatal H1N1-vaccine responses in mothers, but the benefits of maternal VAS in transplacental antibody transfer may depend on the time of gestation when mothers were vaccinated. This trial was registered at clinicaltrials.gov as NCT00817661.",2018,"Overall, HAI in cord blood did not differ between groups, but in the placebo group, cord blood HAI was negatively associated with maternal ""vaccination-to-delivery intervals"" (rs = -0.401; P = 0.5), and maternal VAS increased cord blood HAI 6-fold if antenatal immunization was administered ≥10 wk before delivery. ","['mothers and their infants at 6 mo of age', 'pregnant women (n\xa0=\xa0112) during the second trimester (mean ± SD:\xa014\xa0±\xa01\xa0wk']","['Vitamin A Supplementation', 'placebo', 'oral vitamin A supplementation (VAS', 'inactivated pandemic H1N1-influenza vaccine', 'vitamin A or placebo', 'vitamin']","['pandemic H1N1-vaccine responses', 'Hemagglutination-inhibition (HAI) titer', 'maternal VAS increased cord blood HAI 6-fold if antenatal immunization', 'maternal ""vaccination-to-delivery intervals', 'HAI titer', 'Overall, HAI in cord blood', 'cord blood HAI', 'HAI titers', 'low plasma retinol concentrations']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.665212,"Overall, HAI in cord blood did not differ between groups, but in the placebo group, cord blood HAI was negatively associated with maternal ""vaccination-to-delivery intervals"" (rs = -0.401; P = 0.5), and maternal VAS increased cord blood HAI 6-fold if antenatal immunization was administered ≥10 wk before delivery. ","[{'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md J', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Afsana', 'Initials': 'A', 'LastName': 'Khanam', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Mamunur', 'Initials': 'M', 'LastName': 'Rashid', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Yearul', 'Initials': 'Y', 'LastName': 'Kabir', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Infectious Diseases Division, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Steinhoff', 'Affiliation': ""Global Health Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}]",The Journal of nutrition,['10.1093/jn/nxy228'] 1071,31060632,"Predictors of functional response and remission with desvenlafaxine 50 mg and 100 mg: a pooled analysis of randomized, placebo-controlled studies in patients with major depressive disorder.","OBJECTIVE. The value of early functional improvement at week 2 for predicting subsequent functional outcomes at week 8 was assessed in a pooled analysis of patients with major depressive disorder (MDD) treated with desvenlafaxine (50 or 100 mg/d) or placebo. METHODS. Data were pooled from eight double-blind, placebo-controlled studies of desvenlafaxine 50 mg/d or 100 mg/d for the treatment of MDD. Optimal week-2 improvement thresholds in Sheehan Disability Scale (SDS) score, which best predicted week-8 treatment success, were determined using receiver operating characteristic (ROC) analysis. Four definitions of treatment success were established: (1) functional response, (2) functional/depression response, (3) functional remission, and (4) functional/depression remission. Odds ratios (ORs) of early improvement for prediction (based on thresholds determined in the ROC analysis) of week-8 treatment success were computed using logistic regression models. RESULTS. Functional early improvement thresholds of 17%-32% were predictive of week-8 treatment success across treatment groups and definitions of treatment success. Optimal thresholds were higher for more stringent definitions. Negative predictive value exceeded positive predictive value, indicating that failure to achieve early functional improvement was more informative about later treatment success than was the achievement of early functional improvement. Early change in SDS was a highly significant predictor of functional response/remission (ORs, 4.981-8.737; all p < 0.0001); the interaction between treatment and early functional improvement was not significant. CONCLUSION. Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.",2020,"Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.","['patients with major depressive disorder (MDD) treated with', 'patients with major depressive disorder']","['desvenlafaxine 50\xa0mg', 'placebo', 'desvenlafaxine']","['Odds ratios (ORs) of early improvement for prediction', 'Sheehan Disability Scale (SDS) score', 'SDS total score', 'functional response/remission', 'functional response, (2) functional/depression response, (3) functional remission, and (4) functional/depression remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3665176', 'cui_str': 'Desvenlafaxine 50 MG [Khedezla]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.143237,"Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.","[{'ForeName': 'Claudio N', 'Initials': 'CN', 'LastName': 'Soares', 'Affiliation': ""Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Dalia B', 'Initials': 'DB', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': 'Pfizer Canada Inc, Kirkland, QC, Canada.'}]",CNS spectrums,['10.1017/S1092852919000828'] 1072,31651403,Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial.,"BACKGROUND We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists' concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. TRIAL REGISTRATION ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.",2019,"At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group.",['229 patients'],['Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy'],"['lower symptom load regarding depressive symptoms', 'quality of life (d=0.43) and self-esteem', 'Beck Depression Inventory-II (BDI-II) improved over time', 'Course of Depressive Symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",229.0,0.205519,"At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Zwerenz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Baumgarten', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': ""Institute for Teachers' Health, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Tibubos', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Clinic for Psychosomatic Medicine, Rhön-Klinikum AG, Bad Neustadt/ Saale, Germany.'}, {'ForeName': 'Rudolf J', 'Initials': 'RJ', 'LastName': 'Knickenberg', 'Affiliation': 'Clinic for Psychosomatic Medicine, Rhön-Klinikum AG, Bad Neustadt/ Saale, Germany.'}, {'ForeName': 'Manfred E', 'Initials': 'ME', 'LastName': 'Beutel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.'}]",Journal of medical Internet research,['10.2196/13655'] 1073,31563366,Effects of myofascial trigger point dry cupping on pain and function in patients with plantar heel pain: A randomized controlled trial.,"OBJECTIVE To investigate the effects of dry cupping on calf muscle myofascial trigger points (MTrPs) on pain and function in patients with plantar heel pain. METHODS Seventy-one patients were randomly divided into an intervention group or control group. Both groups performed stretching exercises for the calf muscle and plantar fascia and ankle dorsiflexion exercises. The intervention group also received dry cupping. The primary outcome measures were visual analogue scale (VAS), pressure pain threshold (PPT), and patient-specific functional scale (PSFS). The secondary outcomes were ankle dorsiflexion range of motion (ROM) and ankle plantar flexor strength. These measurements were performed at baseline, immediately after intervention, and after 2 days. RESULTS Current VAS significantly decreased immediately in the intervention group (p = 0.002), but not in the control group (p ≥ 0.220). Morning VAS decreased significantly in both groups (p < 0.001) after 2 days, but decreased more in the intervention group (p = 0.006). Trigger point PPT significantly improved immediately in the intervention group (p = 0.003), but not in the control group (p = 0.112). Both groups improved significantly in PSFS (p < 0.001) and ankle dorsiflexion ROM (p < 0.001). Plantar flexor strength significantly increased immediately in the intervention group (p < 0.001), but not in the control group (p = 0.556). CONCLUSION Adding dry cupping on calf MTrPs to self-stretching and ankle dorsiflexion exercises for patients with plantar heel pain was superior to only self-stretching and active ankle dorsiflexion exercises in pain, ankle dorsiflexion ROM, and plantar flexor strength.",2019,"Plantar flexor strength significantly increased immediately in the intervention group (p < 0.001), but not in the control group (p = 0.556). ","['Seventy-one patients', 'patients with plantar heel pain']","['dry cupping', 'intervention group or control group', 'myofascial trigger point dry cupping', 'stretching exercises for the calf muscle and plantar fascia and ankle dorsiflexion exercises', 'dry cupping on calf muscle myofascial trigger points (MTrPs']","['Morning VAS', 'visual analogue scale (VAS), pressure pain threshold (PPT), and patient-specific functional scale (PSFS', 'pain, ankle dorsiflexion ROM, and plantar flexor strength', 'pain and function', 'Trigger point PPT', 'Plantar flexor strength', 'ankle dorsiflexion ROM', 'Current VAS', 'ankle dorsiflexion range of motion (ROM) and ankle plantar flexor strength', 'PSFS']","[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain (finding)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0394663', 'cui_str': 'Cupping (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}]","[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",71.0,0.0375575,"Plantar flexor strength significantly increased immediately in the intervention group (p < 0.001), but not in the control group (p = 0.556). ","[{'ForeName': 'Nazar', 'Initials': 'N', 'LastName': 'AlKhadhrawi', 'Affiliation': 'Department of Physical Therapy, Qatif Central Hospital, P.O.Box: 3718 Qudaih, Unit No. 1, Qatif, 32661, Saudi Arabia. Electronic address: ntk1406@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alshami', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Saudi Arabia. Electronic address: alshami@iau.edu.sa.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.016'] 1074,17139070,Inventing the randomized double-blind trial: the Nuremberg salt test of 1835.,,2006,,[],[],[],[],[],[],,0.606268,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stolberg', 'Affiliation': 'Institut für Geschichte der Medizin, Oberer Neubergweg 10a, 97074 Würzburg, Germany.'}]",Journal of the Royal Society of Medicine,[] 1075,17187801,Pyridoxine (vitamin B6) therapy for premenstrual syndrome.,,2007,,['premenstrual syndrome'],['Pyridoxine (vitamin B6) therapy'],[],"[{'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0415387,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran. maryamkashanian@yahoo.com'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mazinani', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jalalmanesh', 'Affiliation': ''}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,[] 1076,31738179,Quality Awareness and Its Influence on the Evaluation of App Meta-Information by Physicians: Validation Study.,"BACKGROUND Meta-information provided about health apps on app stores is often the only readily available source of quality-related information before installation. OBJECTIVE The purpose of this study was to assess whether physicians deem a predefined set of quality principles as relevant for health apps; whether they are able to identify corresponding information in a given sample of app descriptions; and whether, and how, this facilitates their informed usage decisions. METHODS All members of the German Society for Internal Medicine were invited by email to participate in an anonymous online survey over a 6-week period. Participants were randomly assigned one app description focusing on cardiology or pulmonology. In the survey, participants were asked three times about whether the assigned description sufficed for a usage decision: they were asked (1) after giving an appraisal of the relevance of nine predefined app quality principles, (2) after determining whether the descriptions covered the quality principles, and (3) after they assessed the availability of detailed quality information by means of 25 additional key questions. Tests for significance of changes in their decisions between assessments 1 and 2, and between assessments 2 and 3, were conducted with the McNemar-Bowker test of symmetry. The effect size represents the discordant proportion ratio sum as a quotient of the test statistics of the Bowker test and the number of observation units. The significance level was set to alpha=.05 with a power of 1-beta=.95. RESULTS A total of 441 of 724 participants (60.9%) who started the survey fully completed the questionnaires and were included in the evaluation. The participants predominantly rated the specified nine quality principles as important for their decision (approximately 80%-99% of ratings). However, apart from the practicality criterion, information provided in the app descriptions was lacking for both groups (approximately 51%-92%). Reassessment of the apps led to more critical assessments among both groups. After having familiarized themselves with the nine quality principles, approximately one-third of the participants (group A: 63/220, 28.6%; group B: 62/221, 28.1%) came to more critical usage decisions in a statistically significant manner (McNemar-Bowker test, groups A and B: P<.001). After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A: P=.13; group B: P=.05). CONCLUSIONS Sensitizing physicians to the topic of quality principles via questions about attitudes toward established quality principles, and letting them apply these principles to app descriptions, lead to more critical appraisals of the sufficiency of the information they provided. Even working with only nine generic criteria was sufficient to bring about the majority of decision changes. This may lay the foundation for aiding physicians in their app-related decision processes, without unduly taking up their valuable time.",2019,"After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A","['All members of the German Society for Internal Medicine were invited by email to participate in an anonymous online survey over a 6-week period', 'A total of 441 of 724 participants (60.9%) who started the survey fully completed the questionnaires and were included in the evaluation']",['cardiology or pulmonology'],[],"[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}]",[],724.0,0.0503387,"After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A","[{'ForeName': 'Urs-Vito', 'Initials': 'UV', 'LastName': 'Albrecht', 'Affiliation': 'Peter L Reichertz Institute for Medical Informatics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Framke', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'von Jan', 'Affiliation': 'Peter L Reichertz Institute for Medical Informatics, Hannover Medical School, Hannover, Germany.'}]",JMIR mHealth and uHealth,['10.2196/16442'] 1077,31599729,A Smart Mobile Health Tool Versus a Paper Action Plan to Support Self-Management of Chronic Obstructive Pulmonary Disease Exacerbations: Randomized Controlled Trial.,"BACKGROUND Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs. OBJECTIVE This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals. METHODS In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models. RESULTS Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good. CONCLUSIONS This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan. TRIAL REGISTRATION ClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.",2019,"This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan.","['Chronic Obstructive Pulmonary Disease Exacerbations', 'patients with COPD', 'patients with COPD used the smart mHealth tool (intervention group) or a', '87 patients with COPD recruited from primary and secondary care centers', 'COPD patients', 'patients with chronic obstructive pulmonary disease (COPD']","['paper action plan (control group', 'smart mobile health (mHealth']","['health status, self-efficacy, self-management behavior, and health care utilization', 'exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization', 'health status, self-efficacy, self-management behavior, health care utilization, and usability', 'automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions']","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Hospital'}]","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",43.0,0.133629,"This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan.","[{'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Boer', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bischoff', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van der Heijden', 'Affiliation': 'Institute for Computing and Information Science, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lucas', 'Affiliation': 'Institute for Computing and Information Science, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Akkermans', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vercoulen', 'Affiliation': 'Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heijdra', 'Affiliation': 'Department of Pulmonary Diseases, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Assendelft', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Tjard', 'Initials': 'T', 'LastName': 'Schermer', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/14408'] 1078,29417694,Inferring distinct mechanisms in the absence of subjective differences: Placebo and centrally acting analgesic underlie unique brain adaptations.,"Development and maintenance of chronic pain is associated with structural and functional brain reorganization. However, few studies have explored the impact of drug treatments on such changes. The extent to which long-term analgesia is related to brain adaptations and its effects on the reversibility of brain reorganization remain unclear. In a randomized placebo-controlled clinical trial, we contrasted pain relief (3-month treatment period), and anatomical (gray matter density [GMD], assessed by voxel-based morphometry) and functional connectivity (resting state fMRI nodal degree count [DC]) adaptations, in 39 knee osteoarthritis (OA) patients (22 females), randomized to duloxetine (DLX, 60 mg once daily) or placebo. Pain relief was equivalent between treatment types. However, distinct circuitry (GMD and DC) could explain pain relief in each group: up to 85% of variance for placebo analgesia and 49% of variance for DLX analgesia. No behavioral measures (collected at entry into the study) could independently explain observed analgesia. Identified circuitry were outside of nociceptive circuitry and minimally overlapped with OA-abnormal or placebo response predictive brain regions. Mediation analysis revealed that changes in GMD and DC can influence each other across remote brain regions to explain observed analgesia. Therefore, we can conclude that distinct brain mechanisms underlie DLX and placebo analgesia in OA. The results demonstrate that even in the absence of differences in subjective pain relief, pharmacological treatments can be differentiated from placebo based on objective brain biomarkers. This is a crucial step to untangling mechanisms and advancing personalized therapy approaches for chronic pain.",2018,Pain relief was equivalent between treatment types.,['39 knee osteoarthritis (OA) patients (22 females'],"['duloxetine (DLX, 60 mg once daily) or placebo', 'Placebo', 'placebo']","['subjective pain relief', 'Pain relief', 'pain relief']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.227937,Pain relief was equivalent between treatment types.,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tétreault', 'Affiliation': 'Department of Physiology, Feinberg School of Medicine, Chicago, Illinois, 60611.'}, {'ForeName': 'Marwan N', 'Initials': 'MN', 'LastName': 'Baliki', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Chicago, Illinois, 60611.'}, {'ForeName': 'Alexis T', 'Initials': 'AT', 'LastName': 'Baria', 'Affiliation': 'Department of Physiology, Feinberg School of Medicine, Chicago, Illinois, 60611.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Bauer', 'Affiliation': 'Department of Neuroscience, University of Toledo, Toledo, Ohio, 43614-2598.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schnitzer', 'Affiliation': 'Department of Rheumatology, Feinberg School of Medicine, Chicago, Illinois, 60611.'}, {'ForeName': 'A Vania', 'Initials': 'AV', 'LastName': 'Apkarian', 'Affiliation': 'Department of Physiology, Feinberg School of Medicine, Chicago, Illinois, 60611.'}]",Human brain mapping,['10.1002/hbm.23999'] 1079,30804094,A Protective Mechanism against Illusory Perceptions Is Amygdala-Dependent.,"Most people have a clear sense of body ownership, preserving them from physical harm. However, perceptual body illusions - famously the rubber hand illusion (RHI) - can be elicited experimentally in healthy individuals. We hypothesize that the amygdala, a core component of neural circuits of threat processing, is involved in protective mechanisms against disturbed body perceptions. To test this hypothesis, we started by investigating two monozygotic human twin sisters with focal bilateral amygdala damage due to Urbach-Wiethe disease. Relative to 20 healthy women, the twins exhibited, on two occasions 1 year apart, augmented RHI responses in form of faster illusion onset and increased vividness ratings. Following up on these findings, we conducted a volumetric brain morphometry study involving an independent, gender-mixed sample of 57 healthy human volunteers (36 female, 21 male). Our results revealed a positive correlation between amygdala volume and RHI onset, i.e., the smaller the amygdala, the less time it took the RHI to emerge. This raised the question of whether a similar phenotype would result from experimental amygdala inhibition. To dampen amygdala reactivity, we intranasally administered the peptide hormone oxytocin to the same 57 individuals in a randomized trial before conducting the RHI. Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings. Together, the present series of experiments provides converging evidence for the amygdala's unprecedented role in reducing susceptibility to the RHI, thus protecting the organism from the potentially fatal threats of a distorted bodily self. SIGNIFICANCE STATEMENT Compelling evidence indicates that the amygdala is of vital importance for danger detection and fear processing. However, lethal threats can arise not only from menacing external stimuli but also from distortions in bodily self-perception. Intriguingly, the amygdala's modulatory role in such illusory body perceptions is still elusive. To probe the amygdala's involvement in illusory body experiences, we conducted a multi-methodological series of experiments in a rare human amygdala lesion model, complemented by a morphological and pharmaco-modulatory experiment in healthy volunteers. Our findings convergently suggest that the amygdala's integrity is indispensable for maintaining an unbiased, precise perception of our bodily self. Hence, the amygdala might shield us against distortions in self-perception and the resultant loss of behavioral control of our organism.",2019,"Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings.","['20 healthy women', 'two monozygotic human twin sisters with focal bilateral amygdala damage due to Urbach-Wiethe disease', 'healthy volunteers', '57 healthy human volunteers (36 female, 21 male', 'healthy individuals']","['placebo, oxytocin', 'peptide hormone oxytocin']","['accelerated illusion onset and increased vividness ratings', 'vividness ratings', 'enhanced RHI responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0337521', 'cui_str': 'Twin sister (person)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0023795', 'cui_str': 'Hyalinosis Cutis et Mucosae'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone (substance)'}]","[{'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",20.0,0.0216404,"Compared with placebo, oxytocin treatment yielded enhanced RHI responses, again evident in accelerated illusion onset and increased vividness ratings.","[{'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn 53127, Germany renehurlemann@icloud.com.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2577-18.2019'] 1080,31031314,Short- and long-term results after laparoscopic floppy Nissen fundoplication in elderly versus non-elderly patients.,"Background Laparoscopic anti-reflux surgery could be of benefit in a subset of elderly patients with gastroesophageal reflux disease. However, there are few reports that have evaluated the long-term results. This study examined the effects of age on the short- and long-term (for at least 5 years) outcomes after laparoscopic Nissen fundoplication (LNF). Patients and Methods Patients were divided into four groups as follows: young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91). The database (recorded prospectively) included operating duration, conversion, intra- and early post-operative complication and late outcomes. Mean follow-up was 14.5 years (range 5-24 years). Results Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9%). Hiatal hernia (type I and III) was significantly less frequent in young and adult patients (P < 0.0001). The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients. The hospital stay, conversion (5.4%), intra-operative and early post-operative complications were not influenced by age. Dysphagia was evenly distributed among the groups. Forty-eight (8.4%) patients had recurrence: 15 in the young group (6.8%), 18 in the adult group (7.2%), 11 in the elderly group (12%) and 4 in the very elderly group (36.3%) (P < 0.0001). Conclusions Age does not influence short- and long-term outcomes following LNF. Control of reflux in the elderly is worse than adult patients. Therefore, ageing is a relative contraindication to LNF.",2020,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"['Five hundred and sixty-nine patients met the inclusion criteria: young n = 219 (38.4%); adult n = 248 (43.5%); elderly n = 91 (16.0%) and very elderly n = 11 (1.9', 'elderly patients with gastroesophageal reflux disease', 'elderly versus non-elderly patients', 'young (18-49); adult (50-69); and elderly (70-84), and very elderly (85-91']","['LNF', '\n\n\nLaparoscopic anti-reflux surgery', 'laparoscopic Nissen fundoplication (LNF', 'laparoscopic floppy Nissen fundoplication']","['Hiatal hernia (type I and III', 'hiatal hernia repair', 'operating duration, conversion, intra- and early post-operative complication and late outcomes', 'hospital stay, conversion (5.4%), intra-operative and early post-operative complications', 'recurrence', 'Dysphagia']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]","[{'cui': 'C0399651', 'cui_str': 'Antireflux operation (procedure)'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0857516', 'cui_str': 'Floppy'}]","[{'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",569.0,0.0250195,The operation was significantly longer in elderly and very elderly patients (P < 0.001); the use of drains (P < 0.001) and grafts (P < 0.0001) for hiatal hernia repair was less in young and adult patients.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Schietroma', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Colozzi', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romano', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Pessia', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vicentini', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Carlo Luigi', 'Initials': 'CL', 'LastName': 'Recchia', 'Affiliation': 'Department of Surgery, Hospital SS. Trinità, Sora, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carlei', 'Affiliation': ""Department of Surgery, University of L'Aquila, L'Aquila, Italy.""}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_269_18'] 1081,31031325,A prospective randomized controlled trial comparing conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique.,"Introduction The da Vinci ® X hybrid systems (Intuitive Surgical ® , Sunnyvale CA) provides standard sites recommendations for port placement during robotic surgery; including that for colorectal procedures. The author's encountered challenges while adhering to the provided instructions, such as clash of instruments and arms and need for additional ports, and hence to overcome these challenges attempted a few innovative technical modifications. The surgical results as well as merits of the revised Indian (Manipal) port placement with single docking technique are presented here. Methods Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018. A randomised controlled study was conducted to compare the two techniques. Ten patients were operated using hybrid da Vinci ® 'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique. Result and Conclusions The Indian (Manipal) modifications of port placements are optimal for colorectal procedures such as low anterior resection as well as for ultralow anterior resections. The intraoperative parameters compared between the recommendations of the Intuitive ® (da Vinci ® systems) and attempted modifications demonstrated statistically significant advantages with the use of the revised techniques. The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.",2020,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","['Twenty patients underwent robotic rectal resection at the Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, India, between December 2017 and June 2018']","[""hybrid da Vinci ® 'X' system using the manufacturer's recommendations and 10 by the modified Indian (Manipal) port placement with a single docking technique"", 'conventional Intuitive® procedure card recommended port placement with the modified Indian (Manipal) technique']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",[],10.0,0.0180383,"The improvements offered by this modification include no additional requirements of ports or staplers, lesser clash amongst instruments as well as arms, better mobilisation of splenic flexure amongst others.","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Somashekhar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Deshpande', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Ashwin', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gangasani', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgical Oncology and Robotic Surgery, Manipal Comprehensive Cancer Centre, Bengaluru, Karnataka, India.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_18_19'] 1082,31541874,Peripheral proinflammatory markers are upregulated in abstinent alcohol-dependent patients but are not affected by cognitive bias modification: Preliminary findings.,"BACKGROUND Inflammatory pathways are known to be negatively affected in patients with alcohol use disorder (AUD). Cognitive bias modification (CBM), an emerging behavioral treatment that involves the 're-training' of cognitive biases using computerized tasks, has been reported to reduce alcohol craving and relapse rates. The aim of this study was to compare peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP in AUD patients versus controls and to identify whether CBM treatment affected these biomarkers in AUD patients. METHODS This 3-week double-blind randomized controlled study tested 36 male abstinent AUD patients receiving CBM or placebo-training, who were also compared to 18 male healthy controls. The approach avoidance task (AAT) was used to test the AUD patients before and after training. CBM training took place over 6 sessions, using a joystick-based approach-avoidance task. Blood samples were collected after the pre- and post-AAT test sessions for the AUD groups, and during an outpatient appointment with the controls. RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031). No changes in the CBM versus placebo groups were noted in IL-18, TNF-α and CRP concentrations following pre-post change or within group pretest- posttest analysis. IL-6 and IL-1β levels fell under the lower detection limit, thus were not included in the final analyses. CONCLUSIONS This study confirms that the inflammatory system is altered in AUD. This was the first study that investigated whether CBM training affected proinflammatory markers in AUD patients.",2019,"RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","['AUD patients', '18 male healthy controls', 'patients with alcohol use disorder (AUD', '36 male abstinent AUD patients receiving']","['CBM', 'IL-6', 'CBM training', 'placebo', 'Cognitive bias modification (CBM', 'CBM or placebo-training']","['IL-18, TNF-α and CRP concentrations', 'proinflammatory markers', 'peripheral concentrations of the proinflammatory biomarkers IL-18, IL-6, IL-1β, TNF-α and CRP', 'Blood samples', 'alcohol craving and relapse rates', 'Peripheral proinflammatory markers', 'plasma levels of TNF- α']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",18.0,0.108888,"RESULTS AUD patients, versus controls, presented with significantly higher plasma levels of TNF- α (P < 0.0001) and CRP (P = 0.0031).","[{'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Portelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Corinde E', 'Initials': 'CE', 'LastName': 'Wiers', 'Affiliation': 'Laboratory of Neuroimaging, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xiaobai', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Deschaine', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Gray R', 'Initials': 'GR', 'LastName': 'McDiarmid', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bermpohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Germany; Berlin School of Mind and Brain, Humboldt Universität zu Berlin, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Basic Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, USA; Center for Alcohol and Addiction Studies, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107553'] 1083,31563357,Effects of different strength training volumes and subsequent detraining on strength performance in aging adults.,"The purpose of the present study was to investigate the volume-dependence of upper-body strength performance improvement and the retention effects after detraining in aging adults. Eighteen healthy, untrained, middle-aged volunteers were randomized into two groups: low volume (LV), mean = 494 kg. and high volume (HV), mean = 686 kg. load. Participants were tested and retested before a 12-week (2 times/week) period of RT for baseline values (pre-); after 6 weeks (middle) and 12 weeks of training (post-), and 12 weeks after interruption (detraining - no systematic exercise). On each test day, a five-repetition maximum (5-RM) for the seated row; handgrip strength test (HGS); and local muscular endurance for elbow flexors (LME) were carried out. Participants performed seated row training 2 times per week with a rest interval of at least 48 h between sessions. After 24 sessions of RT (resistance training), LME significantly increased in both groups (p < 0.05), without differences between groups (14 vs. 18%, for LV and HV, respectively). In addition, 5-RM increased in both the LV (22%) and HV (20%) groups. There were no significant increases in HGS in either group (LV 3% and HV 6%). After detraining, both groups lost up to 15% of LME and 5-RM. In untrained, middle-aged adults, there is an increase in maximal dynamic strength and local muscular endurance, independent of volume chosen. Furthermore, after 12 weeks detraining, the loss does not decrease to baseline values.",2019,"After 24 sessions of RT (resistance training), LME significantly increased in both groups (p < 0.05), without differences between groups (14 vs. 18%, for LV and HV, respectively).","['In untrained, middle-aged adults', 'Eighteen healthy, untrained, middle-aged volunteers', 'aging adults']","['strength training volumes and subsequent detraining', 'five-repetition maximum (5-RM) for the seated row; handgrip strength test (HGS); and local muscular endurance for elbow flexors (LME']","['5-RM', 'maximal dynamic strength and local muscular endurance', 'HGS', 'LME', 'strength performance']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",18.0,0.0193786,"After 24 sessions of RT (resistance training), LME significantly increased in both groups (p < 0.05), without differences between groups (14 vs. 18%, for LV and HV, respectively).","[{'ForeName': 'Ewertton de Souza', 'Initials': 'ES', 'LastName': 'Bezerra', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, 88040-900, Brazil; Laboratório de Estudo do Desempenho Humano, Faculdade de Educação Física e Fisioterapia da Universidade Federal do Amazonas, Manaus, 69067-005, Brazil. Electronic address: esbezerra@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diefenthaeler', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, 88040-900, Brazil.'}, {'ForeName': 'Raphael Luiz', 'Initials': 'RL', 'LastName': 'Sakugawa', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, 88040-900, Brazil.'}, {'ForeName': 'Eduardo Lusa', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Escola de Educação Física, Fisioterapia e Dança da Universidade Federal do Rio Grande do Sul, Porto Alegre, 90690-200, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, Navarrabiomed, IdiSNA, CIBER de Fragilidad y Envejecimiento Saludable (CB16/10/00315), Navarre, 31006, Spain.'}, {'ForeName': 'Antônio Renato Pereira', 'Initials': 'ARP', 'LastName': 'Moro', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, 88040-900, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.010'] 1084,31563358,The addition of neurodynamic exercises to extension-oriented exercises among patients with chronic back-related leg pain: A study protocol.,"BACKGROUND Patients with back-related leg pain exhibit nociceptive and neuropathic characteristics. Few studies have investigated the combination of interventions considering these characteristics. OBJECTIVES To investigate if the addition of neurodynamic exercises (EEN) to extension-oriented exercises (EE) promotes additional benefits in individuals with back-related leg pain and a directional preference. METHODS Patients will be randomized to either EE or EEN. Patients from both groups will receive 7 sessions over 3 weeks. Low back and leg pain, function, quality of life, disability, and global perceived effect will be evaluated at baseline, 3 weeks after randomization and 1-month follow-up. A linear mixed model will be used for outcomes analysis.",2019,"Low back and leg pain, function, quality of life, disability, and global perceived effect will be evaluated at baseline, 3 weeks after randomization and 1-month follow-up.","['Patients', 'individuals with back-related leg pain and a directional preference', 'Patients with back-related leg pain exhibit nociceptive and neuropathic characteristics', 'patients with chronic back-related leg pain']","['neurodynamic exercises (EEN) to extension-oriented exercises (EE', 'EE or EEN', 'neurodynamic exercises to extension-oriented exercises']","['Low back and leg pain, function, quality of life, disability, and global perceived effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.147614,"Low back and leg pain, function, quality of life, disability, and global perceived effect will be evaluated at baseline, 3 weeks after randomization and 1-month follow-up.","[{'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Sousa Filho', 'Affiliation': ""Master's Program in Physical Education, Universidade Federal de Sergipe, São Cristovão, Sergipe, Brazil. Electronic address: fernandosouf@hotmail.com.""}, {'ForeName': 'Marta M', 'Initials': 'MM', 'LastName': 'Barbosa Santos', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Sergipe, São Cristovão, Sergipe, Brazil. Electronic address: mmbs.barbosa@gmail.com.'}, {'ForeName': 'Jader P', 'Initials': 'JP', 'LastName': 'de Farias Neto', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Sergipe, São Cristovão, Sergipe, Brazil. Electronic address: jadernetofisio@hotmail.com.'}, {'ForeName': 'Walderi M', 'Initials': 'WM', 'LastName': 'da Silva Junior', 'Affiliation': ""Master's Program in Physical Education, Universidade Federal de Sergipe, São Cristovão, Sergipe, Brazil. Electronic address: walderim@yahoo.com.br.""}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2018.10.008'] 1085,31563362,Effect of neuromuscular training on functional throwing performance and speed in asymptomatic cricket players.,"OBJECTIVE To determine the effect of neuromuscular training on functional throwing performance and speed among asymptomatic cricket players. DESIGN Single-subject A-B-A design. METHOD Forty-three male asymptomatic sub-elite cricket players were recruited from Karnataka Institute of Cricket, Bangalore, India, with a mean age of 20.4 ± 2.03 years. Throwing accuracy and throwing speed were measured using Functional Throwing Performance Index (FTPI) and radar gun respectively, at zero, 12, 24 and 30 weeks in accordance with the A-B-A single-subject design. The neuromuscular training of the throwing arm was performed for 12 weeks, two days a week of supervised training including rhythmic stabilization drills were performed. A non-supervised training session including shoulder strengthening programme was conducted three days a week. RESULT Participants demonstrated significant improvement in throwing accuracy (p < 0.001) and speed (p < 0.001) after 12 weeks of neuromuscular training. Six weeks post-withdrawal of the neuromuscular training on throwing accuracy was not significant (p = 0.117), However, speed was sustained (p = 0.013). CONCLUSION Neuromuscular training showed an improved efficiency in throwing performance following 12 weeks of training in sub-elite cricket players. The sustained effect was not observed following 6 weeks of withdrawal of training.",2019,Neuromuscular training showed an improved efficiency in throwing performance following 12 weeks of training in sub-elite cricket players.,"['asymptomatic cricket players', 'Forty-three male asymptomatic sub-elite cricket players were recruited from Karnataka Institute of Cricket, Bangalore, India, with a mean age of 20.4\u202f±\u202f2.03 years']","['neuromuscular training', 'Neuromuscular training']",['throwing accuracy'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0018288', 'cui_str': 'Crickets'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}]",43.0,0.035965,Neuromuscular training showed an improved efficiency in throwing performance following 12 weeks of training in sub-elite cricket players.,"[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hydar Abbas', 'Affiliation': 'Dept. of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Bangalore, Karnataka, India. Electronic address: hyderabbas99@yahoo.in.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Karvannan', 'Affiliation': 'Dept. of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Bangalore, Karnataka, India. Electronic address: karvannan.h@manipal.edu.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Prem', 'Affiliation': 'Dept. of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Bangalore, Karnataka, India. Electronic address: prem.v@manipal.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2018.02.014'] 1086,31732133,Physiotherapy for Children with Functional Constipation: A Pragmatic Randomized Controlled Trial in Primary Care.,"OBJECTIVE To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care. STUDY DESIGN Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect. RESULTS Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). CONCLUSIONS We find no evidence to recommend physiotherapy for all children with functional constipation in primary care. TRIAL REGISTRATION Netherlands Trial Registry: NTR4797.",2020,"Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). ","['Primary care physicians recruited children diagnosed with functional constipation (n\xa0=\xa0234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n\xa0=\xa011', 'Children', 'children with functional constipation in primary care', 'Children with Functional Constipation', 'children age 4-17\xa0years in primary care']","['conventional treatment plus physiotherapy or conventional treatment alone', 'physiotherapy plus conventional treatment', 'Physiotherapy', 'toilet training, nutritional advice, and laxative prescribing']","['functional constipation', 'treatment success over 8\xa0months, defined as the absence of functional constipation (Rome III criteria) without laxative use', 'treatment success', 'global symptom improvement', 'percentage of children without functional constipation', 'absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect']","[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0040365', 'cui_str': 'Toilet Training'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}]","[{'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.127033,"Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). ","[{'ForeName': 'Jojanneke J G T', 'Initials': 'JJGT', 'LastName': 'van Summeren', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands. Electronic address: j.j.g.t.van.summeren@umcg.nl.'}, {'ForeName': 'Gea A', 'Initials': 'GA', 'LastName': 'Holtman', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lisman-van Leeuwen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Alice H C', 'Initials': 'AHC', 'LastName': 'van Ulsen-Rust', 'Affiliation': 'Pediatric Pelvic Physiotherapy, Pelvicum kinderbekkenfysiotherapie, Groningen, the Netherlands.'}, {'ForeName': 'Merit M', 'Initials': 'MM', 'LastName': 'Tabbers', 'Affiliation': ""Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital/Amsterdam UMC-Location AMC, Amsterdam, the Netherlands.""}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.09.048'] 1087,31067489,Mnemonic strategy training increases neocortical activation in healthy older adults and patients with mild cognitive impairment.,"Learning and memory deficits characterize the diagnosis of amnestic mild cognitive impairment (aMCI), which is widely viewed as a clinical precursor to Alzheimer's type dementia. There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults. Using an ecologically relevant object-location association paradigm, we conducted a randomized, controlled, single-blind study in which healthy older adults and patients with aMCI were randomized to either mnemonic strategy training or a control group that was matched for stimulus exposure. We previously reported that mnemonic strategy training resulted in significantly greater learning and memory improvements compared to the matched exposure condition, in both aMCI patients and healthy controls. The current study examined changes in neocortical activation during encoding in a subset of participants who underwent functional magnetic resonance imaging (fMRI) scanning both before and after training. To minimize potential confounds in between-group comparisons, we employed non-linear cortex based alignment and included only correctly encoded stimuli in our analyses. When re-encoding stimuli learned during training (i.e., trained stimuli), we found a general enhancement of activation in right prefrontal and parietal regions, possibly reflecting practice-related improvement in coordinate spatial processing in all but the aMCI exposure group. Left hemisphere activation was typically only evident in the mnemonic strategy trained participants, regardless of diagnostic status, with the ventrolateral prefrontal cortex appearing especially important for strategy use. While encoding relatively novel stimuli, both mnemonic strategy groups (aMCI patients and healthy controls) demonstrated increased activation in a subset of regions showing change for the trained stimuli, indicating a mnemonic strategy-induced change in the processing of new information. These findings could not be explained by repeated exposure since there was little to no activation overlap in the respective exposure control groups. The current results reinforce the potential benefits of cognitive interventions in these growing populations and indicate that neuroplastic change in key rostral and lateral prefrontal regions mediate this behavioral change.",2020,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","['amnestic mild cognitive impairment (aMCI', 'healthy older adults and patients with mild cognitive impairment', 'healthy older adults', 'healthy older adults and patients with aMCI']","['mnemonic strategy training', 'Mnemonic strategy training', 'functional magnetic resonance imaging (fMRI) scanning']","['neocortical activation', 'learning and memory improvements', 'Left hemisphere activation']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0213011,"There is a growing interest in non-pharmacologic interventions, such as mnemonic strategies, for improving learning and memory in patients with aMCI as well as for maintaining functioning in healthy older adults.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Mental Health Service, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Neuropsychology Section, Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States of America; Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America. Electronic address: bhampste@med.umich.edu.'}, {'ForeName': 'Anthony Y', 'Initials': 'AY', 'LastName': 'Stringer', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Stilla', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sathian', 'Affiliation': 'Department of Rehabilitation Medicine, Emory University, Atlanta, GA, United States of America; Department of Neurology, Emory University, Atlanta, GA, United States of America; Department of Psychology, Emory University, Atlanta, GA, United States of America; Departments of Neurology, Neural & Behavioral Sciences, and Psychology, Pennsylvania State University, Hershey, PA, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.04.011'] 1088,31068063,Remote neuropsychological assessment of elderly Japanese population using the Alzheimer's Disease Assessment Scale: A validation study.,"INTRODUCTION Studies have demonstrated the high agreement of several remote neuropsychological tests using video teleconferencing (VTC) with face-to-face (FTF) tests. However, the reliability of the remotely administered Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog), one of the most commonly used neuropsychological tests to detect cognitive decline, has not been substantially elucidated, particularly in Japanese populations. Therefore, this study aimed to evaluate the reliability of the remotely administered ADAS-cog compared with FTF-administered ADAS-cog among elderly Japanese participants. METHODS Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months. The assessment order (VTC or FTF) was randomized by participants. Participants' scores were compared among the entire sample, as well as subgroups, using intra-class correlation coefficients (ICCs) in a mixed-effects model. RESULTS A total of 73 participants were included in the study (36 men; age, 76.3 ± 7.6 years). The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74). DISCUSSION The results indicate that a VTC-administered ADAS-cog could be an alternative for an FTF-administered ADAS-cog, although further replication studies with larger sample sizes and a wider range of cognitive functionalities are warranted.",2019,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74). ","[""elderly Japanese population using the Alzheimer's Disease Assessment Scale"", 'A total of 73 participants were included in the study (36 men; age, 76.3\u2009±\u20097.6 years', 'Participants aged ≥60 years with and without cognitive impairment, i.e. those with mild cognitive impairment (MCI), those with dementia and healthy controls (HCs), were assessed with the ADAS-cog using VTC and FTF testing at an interval of >2 weeks and <3 months', 'elderly Japanese participants']","['FTF-administered ADAS-cog', 'video teleconferencing (VTC']",['ADAS-cog total score'],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",73.0,0.059487,"The ICC for the ADAS-cog total score was high in the entire sample (0.86), whereas ICCs were moderate to high for the subgroups (MCI: 0.63, dementia: 0.80 and HC: 0.74). ","[{'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sato', 'Affiliation': 'Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Iiboshi', 'Affiliation': 'Department of Clinical Psychology, Faculty of Human Relations, Shigakukan University, Kagoshima, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Kishimoto', 'Affiliation': 'Hoshi Hospital, Fukushima, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19845278'] 1089,31068096,The study design of ComAlong Toddler: a randomised controlled trial of an early communication intervention.,"Aims: This study design article aims to describe a research study focused on evaluating the use of the Infant-Toddler Checklist to identify children at 18 months with early communication difficulties, and to study the ComAlong Toddler intervention for parents to support their child's communication development. Background : Communication disorders are a common public health problem affecting up to 20% of children. Evidence points to the importance of early detection and intervention to improve young children's communicative abilities and decrease developmental delay. Early identification of communication difficulties is possible with instruments such as Infant-Toddler Checklist. The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis. The parents are provided with guidance in communication enhancing strategies during home visit and five group sessions. Methods : The study uses a prospective cohort design. Children were consecutively recruited during 2015-2017, and data will be collected 2015-2023. The screening was performed at the child health centre through use of the Infant-Toddler Checklist. An assessment and first consultation were then performed by a speech and language therapist for children with suspected communication delay according to the screen as well as for children referred for other reasons before the age of 2.5 years. Children with confirmed communication delay were randomised between two interventions: the ComAlong Toddler parental course or a telephone follow-up. Outcome measures include child communication and language skills and use of augmentative and alternative communication. To gain insight into the participants' perspectives, surveys have been collected from parents. Conclusion: The study will provide information regarding identification and intervention for 18-month old children with communication delay. Trial registration: ISRCTN13330627.",2020,The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis.,"['children with suspected communication delay according to the screen as well as for children referred for other reasons before the age of 2.5\u2009years', ""children at 18\u2009months with early communication difficulties, and to study the ComAlong Toddler intervention for parents to support their child's communication development"", '18-month old children with communication delay', 'Children were consecutively recruited during 2015-2017, and data will be collected 2015-2023', 'Children with confirmed communication delay']",['ComAlong Toddler parental course or a telephone follow-up'],['child communication and language skills and use of augmentative and alternative communication'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}]","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",,0.0451563,The ComAlong Toddler intervention is tailored to the needs of parents of young children with communication delay before definitive diagnosis.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fäldt', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Sweden.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Fabian', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Thunberg', 'Affiliation': 'Dart Centre for Augmentative and Alternative Communication (AAC) and Assistive Technology (AT), Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lucas', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Sweden.""}]",Scandinavian journal of public health,['10.1177/1403494819834755'] 1090,30999262,Can an online curriculum improve the daily socio-emotional lives of middle-aged adults exposed to childhood Trauma?,"One pathway linking experiences of childhood trauma to poorer mental and physical health in midlife are disruptions in daily socio-emotional regulation. However, there is a dearth of effective and accessible treatments that meet the needs of trauma-exposed individuals and their communities. Through a randomized controlled trial, this research examines whether an online social intelligence training (SIT) program improves social-emotional regulation compared to an attention-control (AC) condition. During the pre- and post-test phases of the study, participants (N = 230) completed online surveys for 14-days that included measures of social connectedness, emotional awareness, and perspective-taking. In the SIT condition, multi-level analyses revealed significant increases in daily levels of ""in-tune"" social interactions, emotional awareness, and perspective-taking, and attenuated within-person changes in social engagement on stressful and uplifting days. Participants who reported greater childhood trauma exhibited the strongest increases in daily social engagement and emotional awareness, suggesting that program benefits were largest for those reporting greater exposure to trauma in childhood. Our findings shed light on the potential reversibility of socio-emotional mechanisms linking childhood trauma to poorer mental and physical health in midlife, and support the utility of widely accessible, low-cost intervention methods for individuals and communities.",2019,"In the SIT condition, multi-level analyses revealed significant increases in daily levels of ""in-tune"" social interactions, emotional awareness, and perspective-taking, and attenuated within-person changes in social engagement on stressful and uplifting days.","['participants (N\u202f=\u202f230) completed online surveys for 14-days that included measures of social connectedness, emotional awareness, and perspective-taking', 'middle-aged adults']",['online social intelligence training (SIT) program'],"['daily levels of ""in-tune"" social interactions, emotional awareness, and perspective-taking, and attenuated within-person changes in social engagement on stressful and uplifting days', 'daily social engagement and emotional awareness', 'social-emotional regulation', 'daily socio-emotional lives']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2717811', 'cui_str': 'Intelligences, Social'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0419461,"In the SIT condition, multi-level analyses revealed significant increases in daily levels of ""in-tune"" social interactions, emotional awareness, and perspective-taking, and attenuated within-person changes in social engagement on stressful and uplifting days.","[{'ForeName': 'Saul A', 'Initials': 'SA', 'LastName': 'Castro', 'Affiliation': 'Arizona State University, USA. Electronic address: sacastr1@asu.edu.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Infurna', 'Affiliation': 'Arizona State University, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Arizona State University, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Waldron', 'Affiliation': 'Arizona State University, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Zautra', 'Affiliation': 'Social Intelligence Institute, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.03.012'] 1091,31351667,Re: Multicenter Prospective Phase II Trial of Neoadjuvant Dose-dense Gemcitabine Plus Cisplatin in Patients with Muscle-invasive Bladder Cancer.,,2019,,['Patients with Muscle-invasive Bladder Cancer'],['Neoadjuvant Dose-dense Gemcitabine Plus Cisplatin'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.0142864,,"[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Voskuilen', 'Affiliation': 'Department of Surgical Oncology (Urology), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas W G', 'Initials': 'BWG', 'LastName': 'van Rhijn', 'Affiliation': 'Department of Surgical Oncology (Urology), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. Electronic address: b.v.rhijn@nki.nl.'}]",European urology,['10.1016/j.eururo.2019.07.019'] 1092,31030165,"Pinitol consumption improves liver health status by reducing oxidative stress and fatty acid accumulation in subjects with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","Non-alcoholic fatty liver disease (NAFLD) is the most prevalent cause of chronic hepatic injury in the world. One of the most important therapeutic strategies for this disease is modulating oxidative stress. This study hypothesized that supplementation of pinitol might exert hepatic protective effects, by modulating oxidative stress in subjects with NAFLD. A randomized, double-blind controlled trial was conducted in 90 subjects with ultrasonography-proven NAFLD, who were randomly assigned to the placebo, low-dose (300 mg/d), or high-dose (500 mg/d) of pinitol for 12 weeks. The outcome measures were liver fat content, liver enzymes, fasting and postprandial lipids, and oxidative stress levels. To understand the underlying mechanism, plasma metabolomic analysis based on a gas chromatography/time-of-flight mass spectrometry and urinary pinitol analysis were also performed. The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group. The metabolomic analysis identified 27 differential metabolites involved in glycine/serine/threonine metabolism, alanine/aspartate/glutamate metabolism, D-glutamine/D-glutamate metabolism, and fatty acid synthesis, implicating the role of pinitol in glutathione-related lipid and energy metabolism. These results suggest that pinitol may exert modulatory effects upon energy and metabolic pathways by reducing oxidative stress and fatty acid accumulation, which can lead to hepatoprotective benefits in NAFLD subjects.",2019,"The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group.","['subjects with non-alcoholic fatty liver disease', '90 subjects with ultrasonography-proven NAFLD', 'subjects with NAFLD']","['Pinitol consumption', 'placebo']","['liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations', 'liver fat content, liver enzymes, fasting and postprandial lipids, and oxidative stress levels', 'oxidative stress and fatty acid accumulation', 'glutathione peroxidase level', 'liver health status']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]","[{'cui': 'C0071094', 'cui_str': 'pinitol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",90.0,0.441752,"The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group.","[{'ForeName': 'Eunok', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea.'}, {'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Kwon', 'Affiliation': 'CHA Bundang Medical Center, CHA University, Seongnam, Gyeonggi-do, 13496, Republic of Korea. Electronic address: wizard95@cha.ac.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea. Electronic address: orank@ewha.ac.kr.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.03.006'] 1093,31714321,Effects of Passiflora incarnata Linnaeus on polysomnographic sleep parameters in subjects with insomnia disorder: a double-blind randomized placebo-controlled study.,"The purpose of the present double-blind randomized placebo-controlled clinical study was to investigate the effects of Passionflower on polysomnographic sleep parameters in subjects with insomnia disorder. A total number 110 adult participants (mean age = 40.47 ± 11.68, Female = 53.6%) met the inclusion criteria of insomnia disorder according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders). After randomization, patients received either the Passionflower extract or the placebo for 2 weeks. Patients underwent an overnight polysomnography and completed sleep diaries, Insomnia Severity Index, and Pittsburgh Sleep Quality Index. Within group comparisons were analyzed with paired t-tests or Wilcoxon's signed rank tests, and between-group comparisons were analyzed with independent t-tests or Mann-Whitney U Tests, as appropriate. Total sleep time (TST) was significantly increased in the Passionflower group compared with placebo (Passionflower vs placebo, 23.05 ± 54.26 vs -0.16 ± 53.12; P = 0.049). Sleep efficiency and wake after sleep onset (WASO) significantly improved after 2 weeks in the Passionflower group but there was no difference compared with the placebo group. The current study demonstrated the positive effects of Passionflower on objective sleep parameters including TST on polysomnography in adults with insomnia disorder. Further study is needed to investigate the clinical efficacy of Passionflower on insomnia.",2020,Sleep efficiency and wake after sleep onset (WASO) significantly improved after 2 weeks in the Passionflower group but there was no difference compared with the placebo group.,"['A total number 110 adult participants (mean age = 40.47 ± 11.68, Female = 53.6%) met the inclusion criteria of insomnia disorder according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders', 'subjects with insomnia disorder', 'adults with insomnia disorder']","['Passiflora incarnata Linnaeus', 'placebo (Passionflower vs placebo', 'placebo', 'overnight polysomnography', 'Passionflower extract or the placebo', 'Passionflower']","['polysomnographic sleep parameters', 'sleep diaries, Insomnia Severity Index, and Pittsburgh Sleep Quality Index', 'objective sleep parameters', 'Total sleep time (TST', 'Sleep efficiency and wake after sleep onset (WASO']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}]","[{'cui': 'C2919980', 'cui_str': 'passiflora incarnata flowering top extract'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0330470', 'cui_str': 'Passionflower'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",110.0,0.278335,Sleep efficiency and wake after sleep onset (WASO) significantly improved after 2 weeks in the Passionflower group but there was no difference compared with the placebo group.,"[{'ForeName': 'Jeewon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Han-Young', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Soyoung Irene', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Ji Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Otorhinolaryngology - Head and Neck Surgery, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Shin-Gyeom', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Departments of Psychiatry.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000291'] 1094,31699109,Offline effects of transcranial direct current stimulation on reaction times of lower extremity movements in people after stroke: a pilot cross-over study.,"BACKGROUND Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown promise for rehabilitation after stroke. Ipsilesional anodal tDCS (a-tDCS) over the motor cortex increases corticospinal excitability, while contralesional cathodal tDCS (c-tDCS) restores interhemispheric balance, both resulting in offline improved reaction times of delayed voluntary upper-extremity movements. We aimed to investigate whether tDCS would also have a beneficial effect on delayed leg motor responses after stroke. In addition, we identified whether variability in tDCS effects was associated with the level of leg motor function. METHODS In a cross-over design, 13 people with chronic stroke completed three 15-min sessions of anodal, cathodal and sham stimulation over the primary motor cortex on separate days in an order balanced across participants. Directly after stimulation, participants performed a comprehensive set of lower-extremity tasks involving the paretic tibialis anterior (TA): voluntary ankle-dorsiflexion, gait initiation, and backward balance perturbation. For all tasks, TA onset latencies were determined. In addition, leg motor function was determined by the Fugl-Meyer Assessment - leg score (FMA-L). Repeated measures ANOVA was used to reveal tDCS effects on reaction times. Pearson correlation coefficients were used to establish the relation between tDCS effects and leg motor function. RESULTS For all tasks, TA reaction times did not differ across tDCS sessions. For gait initiation and backward balance perturbation, differences between sham and active stimulation (a-tDCS or c-tDCS) did not correlate with leg motor function. Yet, for ankle dorsiflexion, individual reaction time differences between c-tDCS and sham were strongly associated with FMA-L, with more severely impaired patients exhibiting slower paretic reaction times following c-tDCS. CONCLUSION We found no evidence for offline tDCS-induced benefits. Interestingly, we found that c-tDCS may have unfavorable effects on voluntary control of the paretic leg in severely impaired patients with chronic stroke. This finding points at potential vicarious control from the unaffected hemisphere to the paretic leg. The absence of tDCS-induced effects on gait and balance, two functionally relevant tasks, shows that such motor behavior is inadequately stimulated by currently used tDCS applications. TRIAL REGISTRATION The study is registered in the Netherlands Trial Register (NL5684; April 13th, 2016).",2019,"Yet, for ankle dorsiflexion, individual reaction time differences between c-tDCS and sham were strongly associated with FMA-L, with more severely impaired patients exhibiting slower paretic reaction times following c-tDCS. ","['severely impaired patients with chronic stroke', '13 people with chronic stroke', 'people after stroke']","['anodal, cathodal and sham stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation', 'comprehensive set of lower-extremity tasks involving the paretic tibialis anterior (TA): voluntary ankle-dorsiflexion, gait initiation, and backward balance perturbation', 'sham and active stimulation (a-tDCS or c-tDCS', 'Ipsilesional anodal tDCS (a-tDCS']","['leg motor function', 'tDCS effects and leg motor function', 'TA reaction times', 'paretic reaction times', 'TA onset latencies']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.053821,"Yet, for ankle dorsiflexion, individual reaction time differences between c-tDCS and sham were strongly associated with FMA-L, with more severely impaired patients exhibiting slower paretic reaction times following c-tDCS. ","[{'ForeName': 'Milou J M', 'Initials': 'MJM', 'LastName': 'Coppens', 'Affiliation': 'Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands. Milou.Coppens@radboudumc.nl.'}, {'ForeName': 'Wouter H A', 'Initials': 'WHA', 'LastName': 'Staring', 'Affiliation': 'Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander C H', 'Initials': 'ACH', 'LastName': 'Geurts', 'Affiliation': 'Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Weerdesteyn', 'Affiliation': 'Department of Rehabilitation, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, PO Box 9101, 6500, HB, Nijmegen, The Netherlands.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0604-y'] 1095,29757354,A Modified Inverted Nipple Correction Technique That Preserves Breastfeeding.,"BACKGROUND An inverted nipple may affect the appearance of the breasts and breastfeeding, but traditional surgical procedures might injure the normal lactiferous ducts and damage sensory functions. OBJECTIVES The aim of the study was to propose a minimally invasive and reliable method that preserves breastfeeding and corrects grade I and II inverted nipples. METHODS This was a randomized controlled trial of 230 female patients with unilateral or bilateral inverted nipples and 30 patients with normal nipples who visited the Preconception Counseling Department of our hospital from February 2009 to January 2016. The nipples in the distractor group underwent an operation with a distractor, while the control nipples were treated with daily exercises. The intervention lasted 6 months. The primary endpoint was full-term pregnancy breastfeeding for 4 months. The secondary endpoint was the completion of lactation without obvious complications, such as mastitis and nipple craze. RESULTS Grade I and II nipples achieved increased height after the distractor was worn for 6 months and at 37 weeks of pregnancy (P < 0.05), while the control nipples achieved only a marginal improvement at 37 weeks of pregnancy. In the distractor group, the success rates were 84.9% and 79.3% for grade I and II nipples, respectively, compared with the control group (52.5% and 38.9%, respectively) (P < 0.05). After treatment with the distractor for 6 months, nipples in the distractor group showed no complications, such as skin numbness or nipple necrosis. CONCLUSIONS The use of a distractor is a reliable and minimally invasive method for correcting grade I and II inverted nipples while preserving breastfeeding. LEVEL OF EVIDENCE: 2 ",2019,The use of a distractor is a reliable and minimally invasive method for correcting grade,['230 female patients with unilateral or bilateral inverted nipples and 30 patients with normal nipples who visited the Preconception Counseling Department of our hospital from February 2009 to January 2016'],[],"['full-term pregnancy breastfeeding for 4 months', 'skin numbness or nipple necrosis', 'height', 'success rates', 'completion of lactation without obvious complications, such as mastitis and nipple craze']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0269269', 'cui_str': 'Inversion of nipple (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C0474171', 'cui_str': 'Pre-pregnancy education'}]",[],"[{'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}]",230.0,0.0370462,The use of a distractor is a reliable and minimally invasive method for correcting grade,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Department of Breast Surgery, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Breast Surgery, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.'}, {'ForeName': 'Yudan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Plastic and Aesthetic Surgery, Huanggang Central Hospital, Hubei, China.'}]",Aesthetic surgery journal,['10.1093/asj/sjy119'] 1096,31563383,Effects of an integrated neuromuscular inhibition technique program on neck muscle strength and endurance in individuals with chronic mechanical neck pain.,"BACKGROUND The aim of this study was to investigate whether the application of the integrated neuromuscular inhibition technique (INIT) combined with therapeutic exercise (TE) can provide faster and greater improvement in maximum isometric strength and isometric endurance of the neck muscles in patients with chronic mechanical neck pain (CMNP). METHODS In this 10-week, single-blind clinical trial, 40 participants (men and women) with CMNP were divided into two groups. The intervention group (IG) followed a TE program in combination with the INIT, while the control group (CG) followed the same TE program without the INIT technique. Changes in maximum isometric strength and isometric endurance of the neck muscles were evaluated before, during, and after the intervention, with follow-up measurements taken at 1, 3, and 6 months after the intervention. Analysis of variance with repeated measures was applied. RESULTS Both groups showed a significant improvement in all dependent measures after the intervention (p < .05). These changes were maintained for both groups 6 months after the intervention. However, the IG showed a greater improvement in the maximum isometric strength of neck flexion and an improved craniocervical flexion test score compared with the CG. CONCLUSION The combination of TE and INIT had a positive effect on neck muscle strength and endurance in individuals suffering from CMNP as compared with TE alone.",2019,The combination of TE and INIT had a positive effect on neck muscle strength and endurance in individuals suffering from CMNP as compared with TE alone.,"['40 participants (men and women) with CMNP', 'patients with chronic mechanical neck pain (CMNP', 'individuals with chronic mechanical neck pain']","['integrated neuromuscular inhibition technique (INIT) combined with therapeutic exercise (TE', 'TE program in combination with the INIT, while the control group (CG) followed the same TE program without the INIT technique', 'TE and INIT', 'integrated neuromuscular inhibition technique program']","['maximum isometric strength and isometric endurance', 'neck muscle strength and endurance', 'craniocervical flexion test score', 'maximum isometric strength and isometric endurance of the neck muscles', 'maximum isometric strength of neck flexion']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0027532', 'cui_str': 'Neck Muscles'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion (finding)'}]",40.0,0.0457578,The combination of TE and INIT had a positive effect on neck muscle strength and endurance in individuals suffering from CMNP as compared with TE alone.,"[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Lytras', 'Affiliation': 'Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, 57001, Thermi, Thessaloniki, Greece. Electronic address: lytrasde@gmail.com.'}, {'ForeName': 'Evaggelos', 'Initials': 'E', 'LastName': 'Sykaras', 'Affiliation': 'Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, 57001, Thermi, Thessaloniki, Greece.'}, {'ForeName': 'Kosmas', 'Initials': 'K', 'LastName': 'Christoulas', 'Affiliation': 'Laboratory of Ergophysiology, Department of Physical Education and Sports Sciences, Aristotle University of Thessaloniki, 57001, Thermi, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Myrogiannis', 'Affiliation': 'Department of Medical School, Laboratory of Hygiene-Medical Statistics, School of Medicine, University Campus, 54124, Thessaloniki, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Kellis', 'Affiliation': 'Laboratory of Neuromechanics, Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloníki, 62110, Agios Ioannis, Serres, Greece.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.004'] 1097,31563384,Walking meditation promotes ankle proprioception and balance performance among elderly women.,"BACKGROUND Age-related change of proprioception affects body balance among the elderly. Walking meditation (WM)-a mindfulness practice-involves focusing on leg movements while walking slowly, possibly improving brain processes for perception and balance adjustments. This study investigates the WM's effects on ankle proprioception and balance among the elderly. METHODS Fifty-eight women aged 69.25 ± 6.06 were randomized into control (n = 29) and WM (n = 29) groups. The WM group engaged in 8 weeks of WM practice (30 min/day, 3 days/week). The absolute angular error of the ankle reposition test (AAE) was measured by an electrogoniometer. The balance performance was evaluated using the Berg Balance Scale (BBS), Functional Reach Test (FRT), and Timed Up and Go test (TUG). Data were analyzed using two-way ANOVA and Bonferroni post hoc test and BBS with nonparametric statistics. RESULTS At baseline, the WM group's AAE, BBS, FRT, and TUG were 4.2 ± 1.6°, 51.3 ± 4.1 points, 21.7 ± 5.7 cm, and 11.1 ± 2.5 s, respectively, whereas those of the control group were 3.6 ± 2.0°, 51.0 ± 5.0 points, 21.6 ± 5.2 cm, and 10.2 ± 3.1 s, respectively. Post-training, WM group showed significant decrease in AAE (2.4 ± 0.9°) and displayed improvements in BBS, FRT, and TUG (55.4 ± 0.9 points, 29.1 ± 5.8 cm, and 8.1 ± 1.1 s, respectively) (p < 0.01). Conversely, the control group presented no change in AAE, significant decreases in BBS and FRT, and slower TUG (p < 0.01). No difference was found between WM and control groups at the baseline. However, post-training, WM group demonstrated significant improvements in AAE, BBS, FRT, and TUG as compared to the control group (p < 0.001). CONCLUSIONS WM practice improved the balance and ankle reposition sense among the elderly. It can be used as an alternative form of training to promote balance and ankle proprioception. The results supported that balance performance worsens among the elders who do not engage in physical training.",2019,"However, post-training, WM group demonstrated significant improvements in AAE, BBS, FRT, and TUG as compared to the control group (p < 0.001). ","['elders who do not engage in physical training', 'Fifty-eight women aged 69.25\u202f±\u202f6.06', 'elderly women']","['Walking meditation (WM)-a mindfulness practice', 'Walking meditation']","['Berg Balance Scale (BBS), Functional Reach Test (FRT), and Timed Up and Go test (TUG', 'balance performance', 'AAE', 'BBS and FRT, and slower TUG', 'AAE, BBS, FRT, and TUG', 'BBS, FRT, and TUG', 'absolute angular error of the ankle reposition test (AAE', 'balance and ankle reposition sense']","[{'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150277'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test (procedure)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]",58.0,0.0240313,"However, post-training, WM group demonstrated significant improvements in AAE, BBS, FRT, and TUG as compared to the control group (p < 0.001). ","[{'ForeName': 'Apsornsawan', 'Initials': 'A', 'LastName': 'Chatutain', 'Affiliation': 'Physical Therapy Division, Faculty of Physical Therapy, Srinakharinwirot University, Ongkharak, Nakhon Nayok, 26120, Thailand.'}, {'ForeName': 'Jindarut', 'Initials': 'J', 'LastName': 'Pattana', 'Affiliation': 'Physical Therapy Division, Faculty of Physical Therapy, Srinakharinwirot University, Ongkharak, Nakhon Nayok, 26120, Thailand.'}, {'ForeName': 'Tunyakarn', 'Initials': 'T', 'LastName': 'Parinsarum', 'Affiliation': 'Physical Therapy Division, Faculty of Physical Therapy, Srinakharinwirot University, Ongkharak, Nakhon Nayok, 26120, Thailand.'}, {'ForeName': 'Saitida', 'Initials': 'S', 'LastName': 'Lapanantasin', 'Affiliation': 'Physical Therapy Division, Faculty of Physical Therapy, Srinakharinwirot University, Ongkharak, Nakhon Nayok, 26120, Thailand. Electronic address: saitida@g.swu.ac.th.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2018.09.152'] 1098,31563386,Comparison of non-steroidal anti-inflammatory drugs and knee kinesio taping in early osteoarthritis pain: A randomized controlled trial.,"NSAID in knee OA impose many related adverse effects. Kinesio taping was recently suggested as a novel conservative treatment for reducing pain in OA, without adverse effects. This study aimed to compare kinesio taping and NSAID therapy for kn.ee OA. There were 37 participants in the first group (mean age, 53.72 ± 8.91 years), 29 participants in the second group (mean age, 50.24 ± 8.63 years), and 18 participants in the third group (mean age, 53.33 ± 8.50 years). These groups were treated with NSAID therapy and kinesio taping, kinesio taping only, and sham taping with NSAID therapy, respectively. Taping was repeated three times a week at 1-day intervals. Participants reported pain each week, using visual analog scale scores. The main effect of group and the pain-group interaction were not statistically significant (P = 0.88 and 0.15, respectively). Pain reduction in different weeks was statistically significant (P < .001). Cohen's effect size values for pain reduction in the first to third groups were 0.70, 0.55, and 0.48, respectively. Pain reduction was observed in the three groups, but there was no significant difference among the various treatments. Kinesio taping as a pain relief method may reduce pharmacotherapy demands or at least delay NSAID prescriptions in patients with early OA.",2019,"Cohen's effect size values for pain reduction in the first to third groups were 0.70, 0.55, and 0.48, respectively.","['37 participants in the first group (mean age, 53.72\u202f±\u202f8.91 years), 29 participants in the second group (mean age, 50.24\u202f±\u202f8.63 years), and 18 participants in the third group (mean age, 53.33\u202f±\u202f8.50 years', 'patients with early OA', 'early osteoarthritis pain']","['non-steroidal anti-inflammatory drugs and knee kinesio taping', 'kinesio taping and NSAID therapy', 'NSAID therapy and kinesio taping, kinesio taping only, and sham taping with NSAID therapy', 'Kinesio taping']","['visual analog scale scores', 'Pain reduction', 'pain in OA, without adverse effects', 'pain reduction']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",37.0,0.056743,"Cohen's effect size values for pain reduction in the first to third groups were 0.70, 0.55, and 0.48, respectively.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hayati', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Yazdi', 'Affiliation': 'Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Abbasi', 'Affiliation': 'Metabolic Disease Research Center, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: dr.mabbasi@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2018.06.011'] 1099,31563387,Immediate effects of ankle eversion taping on gait ability of chronic stroke patients.,"OBJECTIVES The purpose of this study is to assess the immediate effects of applying ankle eversion taping using kinesiology tape in patients with foot drop after stroke. DESIGN Randomized cross-over trial. METHOD In this study, fifteen subjects with stroke underwent three interventions in a random order. Subjects were randomly initially assigned to an ankle balance taping, placebo taping, and no taping each group. The ankle eversion taping was used for mechanical correction. Ankle eversion taping is involved in ankle dorsiflexion and eversion. The placebo taping began from both malleolus and was applied up to the middle point of the lower limb. Gait ability was assessed by the GAITRite System. The measured gait variables are gait velocity, step length, stride length, H-H base support, and cadence. All of the measurements were performed immediately after intervention. RESULTS Our results showed gait function in chronic stroke patients was improved after ankle eversion taping. Velocity, step length, stride length and cadence under the ankle eversion taping conditions significantly increased (p < 0.05) compared to the placebo and no taping conditions. Ankle eversion taping significantly reduced (p < 0.05) H-H base support compared to the no taping condition. CONCLUSIONS We conclude that the application of ankle eversion taping that uses kinesiology tape instantly increased the gait ability of chronic stroke patients with foot drop. However, more research is necessary to identify the long-term effects of the ankle eversion taping.",2019,"Ankle eversion taping significantly reduced (p < 0.05) H-H base support compared to the no taping condition. ","['fifteen subjects with stroke', 'chronic stroke patients', 'patients with foot drop after stroke', 'chronic stroke patients with foot drop']","['Ankle eversion taping', 'placebo', 'ankle eversion taping using kinesiology tape', 'ankle balance taping, placebo taping, and no taping each group', 'ankle eversion taping']","['gait variables are gait velocity, step length, stride length, H-H base support, and cadence', 'gait function', 'gait ability', 'Ankle eversion taping', 'Velocity, step length, stride length and cadence under the ankle eversion taping conditions', 'Gait ability']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085684', 'cui_str': 'Foot Drop'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",15.0,0.046087,"Ankle eversion taping significantly reduced (p < 0.05) H-H base support compared to the no taping condition. ","[{'ForeName': 'Young Jun', 'Initials': 'YJ', 'LastName': 'Shin', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, Daegu University, Jillyang, Gyeongsan, Gyeongbuk, 712-714, Republic of Korea. Electronic address: syj8535@naver.com.'}, {'ForeName': 'Jung Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Nursing and Healthcare Sciences, Dong-Eui University, 176, Eomgwang-ro, Busanjin-gu, Busan, 614-714, Republic of Korea. Electronic address: dreampt@deu.ac.kr.'}, {'ForeName': 'Yu Won', 'Initials': 'YW', 'LastName': 'Choe', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, Daegu University, Jillyang, Gyeongsan, Gyeongbuk, 712-714, Republic of Korea. Electronic address: choiyuwon@naver.com.'}, {'ForeName': 'Myoung Kwon', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Rehabilitation Sciences, Daegu University, Jillyang, Gyeongsan, Gyeongbuk, 712-714, Republic of Korea. Electronic address: skybird-98@hanmail.net.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2018.06.008'] 1100,31868791,Changing in a GIF (Graphics Interchange Format): Innovations in Before and After Photography.,"PURPOSE Before and after images are an important part of aesthetic counseling, but no studies have examined ways to optimize change detection through the layout of displayed images. This study compares 3 different image layouts to determine which presentation style improves perception of postprocedure changes. METHODS In this prospective, randomized study, participants viewed sequential images of patients who either had or had not undergone upper eyelid blepharoptosis repair or blepharoplasty (""change"" and ""no-change,"" respectively). These paired images were randomly presented in 1 of 3 formats: side-by-side, up-and-down, or alternation flicker (in which 2 images are superimposed and alternated in a graphics interchange format). Participants were asked if a procedure had been performed based on the 2 photographs. Paired t tests were used to compare response times and change detection rates between individual-level pairs of presentation modes. RESULTS Of 299 recruited patients, 286 completed the study. Rate of change detection trended toward increased sensitivity for alternation flicker over static images. This became statistically significant for patients less than 45 years old. Detection rates did not differ significantly between the 2 static layouts (side-by-side and up-and down). CONCLUSIONS Enhancing and customizing aesthetics counseling for different ages can improve patient understanding, expectations, and advertising. When using static photography, the layout, whether side-by-side or up-and-down, can be chosen to fit the mode of presentation with no statistically significant difference. To optimize detection of changes in before and after photography in a demographic less than 45 years old, the animated, alternation flicker format was statistically significantly more effective.",2020,"Detection rates did not differ significantly between the 2 static layouts (side-by-side and up-and down). ","['participants viewed sequential images of patients who either had or had not undergone upper eyelid blepharoptosis repair or blepharoplasty (""change"" and ""no-change,"" respectively', '299 recruited patients']",[],"['response times and change detection rates', 'Detection rates']","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0005745', 'cui_str': 'Ptosis, Eyelid'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}]",[],"[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",299.0,0.0168709,"Detection rates did not differ significantly between the 2 static layouts (side-by-side and up-and down). ","[{'ForeName': 'Sruti S', 'Initials': 'SS', 'LastName': 'Akella', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Montefiore Medical Center, Bronx, New York, U.S.A.'}, {'ForeName': 'Tova', 'Initials': 'T', 'LastName': 'Goldstein', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, U.S.A.'}, {'ForeName': 'Shaina', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, Pennsylvania, U.S.A.'}, {'ForeName': 'Parth', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, U.S.A.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social and Health Sciences, Clemson University, Clemson, South Carolina, U.S.A.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Barmettler', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Montefiore Medical Center, Bronx, New York, U.S.A.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001530'] 1101,31093681,Effectiveness of randomized controlled trial of a mobile app to promote healthy lifestyle in obese and overweight patients.,"BACKGROUND Health advice is useful for establishing behavioural changes, but such changes tend not to last. It would therefore be good to identify mechanisms for reinforcing advice and one option is the use of information and communication technologies. Given the limited evidence on the effectiveness of such technologies, we decided to conduct a clinical trial to assess the efficacy of a mobile application (app) for supporting the provision health advice for weight loss. METHODS A randomized clinical trial with 110 obese and overweight patients from the Basque public health care network (Araba). Patients were randomly allocated to the control (health advice) or intervention (health advice + app) groups. Primary (weight) and secondary (blood cholesterol level, blood pressure, haemoglobin A1c (HbA1c) and adherence to dietary and exercise recommendations) outcome variables were assessed at 1, 3 and 6 months after the end of the intervention. RESULTS There were no significant differences in weight (0.357 kg; P = 0.7), blood cholesterol (2.6 mg/dl; P = 0.617), blood pressure (2.3 mmHg; P = 0.369) or adherence to recommendations on diet (84.6% in control and 92.9% the intervention group, P = 0.413) or physical activity (56% in controls and 75% the intervention group, P = 0.145). On the other hand, there were significant differences in HbA1c in favour of the control group (-0.095%; %; P = 0.046). DISCUSSION The use of AKTIDIET® to support health advice for weight loss cannot be recommended. More high quality studies are needed, and patients should be involved in the design of apps to increase their efficacy and usability. CLINICAL TRIAL REGISTRATION NCT02308176.",2019,"There were no significant differences in weight (0.357 kg; P = 0.7), blood cholesterol (2.6 mg/dl; P = 0.617), blood pressure (2.3 mmHg; P = 0.369) or adherence to recommendations on diet (84.6% in control and 92.9% the intervention group, P = 0.413) or physical activity (56% in controls and 75% the intervention group, P = 0.145).","['110 obese and overweight patients from the Basque public health care network (Araba', 'obese and overweight patients']","['control (health advice) or intervention (health advice + app', 'mobile app to promote healthy lifestyle']","['blood cholesterol', 'Primary (weight) and secondary (blood cholesterol level, blood pressure, haemoglobin A1c (HbA1c) and adherence to dietary and exercise recommendations) outcome variables', 'adherence to recommendations on diet', 'blood pressure', 'physical activity', 'weight']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",110.0,0.0852195,"There were no significant differences in weight (0.357 kg; P = 0.7), blood cholesterol (2.6 mg/dl; P = 0.617), blood pressure (2.3 mmHg; P = 0.369) or adherence to recommendations on diet (84.6% in control and 92.9% the intervention group, P = 0.413) or physical activity (56% in controls and 75% the intervention group, P = 0.145).","[{'ForeName': 'Antxon', 'Initials': 'A', 'LastName': 'Apiñaniz', 'Affiliation': 'Osakidetza, OSI Araba, Lakuabizkarra Health Centre, Vitoria-Gasteiz, España.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Cobos-Campos', 'Affiliation': 'Health Research Institute BioAraba, Methodology and Statistics Unit, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Sáez de Lafuente-Moríñigo', 'Affiliation': 'Health Research Institute BioAraba, Methodology and Statistics Unit, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Naiara', 'Initials': 'N', 'LastName': 'Parraza', 'Affiliation': 'Health Research Institute BioAraba, Methodology and Statistics Unit, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Aizpuru', 'Affiliation': 'Osakidetza, Sub-Department of health care, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Iraida', 'Initials': 'I', 'LastName': 'Pérez', 'Affiliation': 'Osakidetza, OSI Araba, Olaguibel Health Centre, Vitoria-Gasteiz, España.'}, {'ForeName': 'Enara', 'Initials': 'E', 'LastName': 'Goicoechea', 'Affiliation': 'Osakidetza, OSI Araba, Lakuabizkarra Health Centre, Vitoria-Gasteiz, España.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Trápaga', 'Affiliation': 'Osakidetza, OSI Araba, Zabalgana Health Centre, Vitoria-Gasteiz, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García', 'Affiliation': 'Osakidetza, OSI Araba, Lakuabizkarra Health Centre, Vitoria-Gasteiz, España.'}]",Family practice,['10.1093/fampra/cmz020'] 1102,31045610,Effects of Virtual Reality in Patients Undergoing Dialysis: Study Protocol.,"Dialysis is often considered slow, repetitive, and with programmed intervals. Patients often perceive it as time taken from their lives with a sense of ineluctability and emptiness, engendering a negative emotional and cognitive perception of the world and one's place in it. Today, it is possible to improve the quality of life of patients during hemodialysis using virtual reality (VR). This creation of a true multisensory experience may absorb the patient's perceptions during hemodialysis, improving his/her quality of life. An Italian multicenter, longitudinal experimental study will be conducted with a randomized, pre-post test design, with balanced allocation 1:1, in parallel groups with a control group in the standard care of patients diagnosed with chronic renal failure who are, undergoing hemodialysis treatment. A sample of 186 patients calculated with sample size (power = 80%, β = 0.2, α = 0.05) will be randomized into an experimental group exposed to VR, and a control group in standard care. The 2 groups will be studied over a period of 1 month, with 12 applications of VR and with measurements of the following outcomes: anxiety, fatigue, pruritus, arterial pressure, heart rate, respiration rate, and duration of the session at each hemodialysis session. This is the first international experimental protocol that examines the application of VR in patients undergoing hemodialysis. If the results show statistically and clinically significant differences, the VR could be an additional holistic intervention, which is evidence based, linked to the humanization of chronic, repetitive interventions, complementary to and synergistic with standard of care.",2019,"If the results show statistically and clinically significant differences, the VR could be an additional holistic intervention, which is evidence based, linked to the humanization of chronic, repetitive interventions, complementary to and synergistic with standard of care.","['patients during hemodialysis using virtual reality (VR', 'patients diagnosed with chronic renal failure who are, undergoing hemodialysis treatment', 'Patients Undergoing Dialysis', '186 patients calculated with sample size (power = 80%, β = 0.2, α = 0.05', 'patients undergoing hemodialysis']","['control group in standard care', 'Virtual Reality']","['quality of life', 'anxiety, fatigue, pruritus, arterial pressure, heart rate, respiration rate, and duration of the session at each hemodialysis session']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",186.0,0.0270518,"If the results show statistically and clinically significant differences, the VR could be an additional holistic intervention, which is evidence based, linked to the humanization of chronic, repetitive interventions, complementary to and synergistic with standard of care.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burrai', 'Affiliation': 'Education, Research and Organizational Change, ATS Sardegna, Sassari, Italy (Dr Burrai); Imperial College London, United Kingdom (Mr Othman); San Raffaele Hospital, Milan, Italy (Ms Brioni); University of Sassari, Telti (SS), Italy (Ms Micheluzzi); Departments of Biomedical and Neuromotor Sciences (Dr Luppi) and Experimental, Diagnostic and Specialty Medicine (Dr La Manna), University of Bologna, Italy; SIAN Research Center, Bologna, Italy (Mr Apuzzo); and IRCCS San Raffaele Hospital, Milan, Italy (Dr Delli Zotti).'}, {'ForeName': 'Shokri', 'Initials': 'S', 'LastName': 'Othman', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Brioni', 'Affiliation': ''}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Micheluzzi', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Luppi', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Apuzzo', 'Affiliation': ''}, {'ForeName': 'Giulia Bruna', 'Initials': 'GB', 'LastName': 'Delli Zotti', 'Affiliation': ''}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'La Manna', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000330'] 1103,31663369,Efficacy of preoperative progressive resistance training in patients undergoing total knee arthroplasty: 12-month follow-up data from a randomized controlled trial.,"OBJECTIVE The aim of this study was to investigate the effect of adding four weeks preoperative progressive resistance training (PRT) to four weeks postoperative PRT on patient function, muscle strength, and other outcomes 12 months after total knee arthroplasty (TKA). DESIGN Twelve-month follow-up data from a previously published randomized controlled trial. SETTING Aarhus University Hospital, Silkeborg Regional Hospital, and Aarhus University. SUBJECTS A total of 59 patients scheduled for TKA were enrolled in a single-blinded, clinical randomized controlled trial. INTERVENTIONS Participants were randomized to preoperative PRT (intervention group) or to a control group who ""lived as usual"" the last four weeks before TKA. The intervention group completed four weeks preoperative and four weeks postoperative PRT, whereas the control group only completed four weeks postoperative PRT. Main follow-up measures were as follows: the 30-second Chair Stand Test (primary outcome), Timed Up and Go Test, walk tests, knee extensor, and knee flexor muscle strength and patient-reported outcomes. Statistical analyses were performed according to the intention-to-treat principle. RESULTS No significant group differences were observed for the primary outcome 30-second Chair Stand Test (4.0 repetitions versus 2.4 repetitions, P  = 0.067) or for other functional performance outcomes. The intervention group had significantly higher weight-normalized knee extensor muscle strength (0.5 Nm/kg versus 0.2 Nm/kg, P  = 0.002) and knee flexor muscle strength (0.3 Nm/kg versus 0.2 Nm/kg, P  = 0.042) in the operated leg when compared to the control group. No significant group differences for patient-reported outcomes. CONCLUSION The study supports the use of short-term high-intensity resistance training before TKA as it induces a long-lasting effect on muscle strength, while it may have no discernible effect on functional performance.",2020,"No significant group differences for patient-reported outcomes. ","['59 patients scheduled for TKA', 'Aarhus University Hospital, Silkeborg Regional Hospital, and Aarhus University', 'patients undergoing total knee arthroplasty']","['control group only completed four\u2009weeks postoperative PRT', 'preoperative progressive resistance training (PRT', 'preoperative progressive resistance training', 'total knee arthroplasty (TKA', 'preoperative PRT (intervention group) or to a control group who ""lived as usual"" the last four\u2009weeks before TKA']","['higher weight-normalized knee extensor muscle strength', '30-second Chair Stand Test (primary outcome), Timed Up and Go Test, walk tests, knee extensor, and knee flexor muscle strength and patient-reported outcomes', 'primary outcome 30-second Chair Stand Test', 'knee flexor muscle strength']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",59.0,0.0934991,"No significant group differences for patient-reported outcomes. ","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Skoffer', 'Affiliation': 'Department of Physical and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maribo', 'Affiliation': 'Centre for Rehabilitation Research, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Christian Gaarden', 'Initials': 'CG', 'LastName': 'Korsgaard', 'Affiliation': 'Section of Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Søballe', 'Affiliation': 'Department of Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section of Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215519883420'] 1104,31722690,Does the treatment of anxiety in children with Attention-Deficit/Hyperactivity Disorder (ADHD) using cognitive behavioral therapy improve child and family outcomes? Protocol for a randomized controlled trial.,"BACKGROUND Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. METHODS This RCT is recruiting children aged 8-12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child's parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. DISCUSSION The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. TRIAL REGISTRATION This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (https://doi.org/10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19.",2019,Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities.,"['children with ADHD and comorbid anxiety compared with usual care', 'Eligible children', 'children aged 8-12\u2009years (N\u2009=\u2009228) from pediatrician practices in Victoria, Australia', 'Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social', 'children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD', ""child's parent (Anxiety Disorders Interview Schedule for Children V""]","['cognitive-behavioral therapy (CBT', 'cognitive behavioral therapy', 'existing CBT intervention', '10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician']","['proportion of children meeting diagnostic criteria for an anxiety disorder', 'range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.122909,Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sciberras', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia. emma.sciberras@deakin.edu.au.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Efron', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Vic, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Anderson', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Nicholson', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Bundoora, Vic, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schembri', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Vic, Australia.""}]",BMC psychiatry,['10.1186/s12888-019-2276-3'] 1105,31607143,Effects of Intensive Versus Standard Ambulatory Blood Pressure Control on Cerebrovascular Outcomes in Older People (INFINITY).,"BACKGROUND Subcortical microvascular disease represented by brain white matter hyperintensity on magnetic resonance imaging is associated with functional decline in older people with hypertension. The effects of 2 levels of 24-hour average systolic blood pressure (BP) on mobility, white matter disease progression, and cognitive function over 3 years were studied. METHODS This trial was a prospective, randomized, blinded end-points study in patients ≥75 years of age with systolic hypertension and magnetic resonance imaging evidence of white matter hyperintensity lesions. Patients were randomized to a 24-hour mean systolic BP of ≤130 mm Hg (intensive treatment) versus ≤145 mm Hg (standard treatment) with antihypertensive therapies. Primary study outcomes were changes in mobility (gait speed) and accrual of white matter hyperintensity volume after 3 years. Changes in cognitive function (executive processing) and adverse events were also evaluated. RESULTS In 199 randomized patients, the mean age of the cohort was 80.5 years, and 54% were women; the average 24-hour systolic BP was 149 mm Hg. Goal BPs were achieved after a median treatment period of 3 to 4 months; at that time, the mean 24-hour systolic BP was 127.7 mm Hg in the intensive treatment group and 144.0 mm Hg in the standard treatment group for an average difference of 16.3 mm Hg. Changes in gait speed were not different between treatment groups (0.40±2.0 versus 0.42±2.7 s in the intensive treatment and standard treatment groups, respectively; P =0.91), whereas changes from baseline in white matter hyperintensity volumes were smaller (0.29%) in the intensive treatment group compared with the standard treatment group (0.48%; P =0.03). Cognitive outcomes also were not different between the treatment groups. Major adverse cardiovascular events were higher in the standard treatment group compared with the intensive treatment group (17 versus 4 patients; P =0.01). Falls, with or without injury, and syncope were comparable in the treatment groups. CONCLUSIONS Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease. Over periods >3 years, a reduction in the accumulation of white matter disease may be a factor in conserving function. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01650402.",2019,Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease.,"['199 randomized patients, the mean age of the cohort was 80.5 years, and 54% were women; the average 24-hour systolic BP was 149 mm\u2009Hg', 'older people with hypertension', 'Older People (INFINITY', 'patients ≥75 years of age with systolic hypertension and magnetic resonance imaging evidence of white matter hyperintensity lesions', 'older patients with hypertension']","['Intensive Versus Standard Ambulatory Blood Pressure Control', '24-hour mean systolic BP of ≤130 mm\u2009Hg (intensive treatment) versus ≤145 mm\u2009Hg (standard treatment) with antihypertensive therapies']","['mean 24-hour systolic BP', 'changes in mobility (gait speed) and accrual of white matter hyperintensity volume', 'white matter hyperintensity volumes', 'cognitive function (executive processing) and adverse events', 'Goal BPs', 'Falls, with or without injury, and syncope', 'Cognitive outcomes', 'mobility outcomes', '24-hour average systolic blood pressure (BP) on mobility, white matter disease progression, and cognitive function', 'Major adverse cardiovascular events', 'ambulatory BP reduction', 'Cerebrovascular Outcomes', 'Changes in gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension (disorder)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0682708'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",199.0,0.106976,Intensive lowering of ambulatory BP reduction in older patients with hypertension did not result in differences in mobility outcomes but was associated with a reduction in accrual of subcortical white matter disease.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center (W.B.W.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Dorothy B', 'Initials': 'DB', 'LastName': 'Wakefield', 'Affiliation': 'Department of Neurology (D.B.W., L.W.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Moscufo', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.M., C.R.G.G.).""}, {'ForeName': 'Charles R G', 'Initials': 'CRG', 'LastName': 'Guttmann', 'Affiliation': ""Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (N.M., C.R.G.G.).""}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Kaplan', 'Affiliation': 'Department of Psychiatry (R.F.K.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Bohannon', 'Affiliation': 'College of Pharmacy and Health Sciences, Campbell University, Buies Creek, NC (R.W.B.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fellows', 'Affiliation': 'Department of Diagnostic Imaging (D.F.), University of Connecticut School of Medicine, Farmington.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology and Population Health and Saul B. Korey Department of Neurology, Albert Einstein College of Medicine, Bronx, NY (C.B.H.).'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wolfson', 'Affiliation': 'Department of Neurology (D.B.W., L.W.), University of Connecticut School of Medicine, Farmington.'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041603'] 1106,31563355,"Effects of a short-term of whole-body, high-intensity, intermittent training program on morphofunctional parameters.","BACKGROUND Few studies have analyzed the application of high-intensity interval training (HIIT) using exercises with body weight among the morphofunctional parameters. AIM To analyze and compare the effects of six weeks of high-intensity intermittent calisthenic training (HIICT) and moderate intensity, continuous exercise (MICT) on body composition, hypertrophy, and strength. MATERIALS AND METHODS Twenty-five active, healthy adults were randomized in either the HIIT group (n = 14) or the MICT group (n = 11). The HIIT group performed high-intensity intermittent calisthenic training based on full body exercise. The training session involved 5 min of warm-up followed by 20 sets of 30s all-out exercise and 30 s of passive recovery between sets. Jumping jack, mountain climber, burpee and squat jump were used. The MICT group performed continuous moderate running (5 min of warm-up followed by 20 min of running with intensity fixed at 80% of maximum heart rate). Training for both groups was performed three times weekly on nonconsecutive days. All subjects underwent anthropometric measurements and functional tests. Muscle thickness was also measured. RESULTS There were no significant changes observed in any anthropometric measurements in both groups. Regarding the functional tests, the analysis of the percentage changes revealed advantages of HIICT over MICT in push-ups only (p = 0.02). The muscular thickness of lower and upper limbs did not present significant differences in the pre- and post-times or between groups (p > 0.05). CONCLUSION When compared to MICT, HIIT improved push-up effects, without generating significant changes in body composition and muscle thickness.",2019,"The muscular thickness of lower and upper limbs did not present significant differences in the pre- and post-times or between groups (p > 0.05). ","['Twenty-five active, healthy adults']","['MICT', 'high-intensity intermittent calisthenic training (HIICT) and moderate intensity, continuous exercise (MICT', 'short-term of whole-body, high-intensity, intermittent training program', 'high-intensity intermittent calisthenic training based on full body exercise']","['muscular thickness of lower and upper limbs', 'morphofunctional parameters', 'body composition and muscle thickness', 'anthropometric measurements', 'body composition, hypertrophy, and strength', 'Muscle thickness']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0006759', 'cui_str': 'Calisthenics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",,0.0189575,"The muscular thickness of lower and upper limbs did not present significant differences in the pre- and post-times or between groups (p > 0.05). ","[{'ForeName': 'Alexandre Lopes', 'Initials': 'AL', 'LastName': 'Evangelista', 'Affiliation': 'Department of Physical Education, Nove de Julho University, São Paulo, SP, Brazil. Electronic address: contato@alexandrelevangelista.com.br.'}, {'ForeName': 'Cauê', 'Initials': 'C', 'LastName': 'La Scala Teixeira', 'Affiliation': 'Group of Studies on Obesity of Federal University of São Paulo, Santos, SP, Brazil; Department of Physical Education, Praia Grande College, Praia Grande, SP, Brazil.'}, {'ForeName': 'Alexandre Fernandes', 'Initials': 'AF', 'LastName': 'Machado', 'Affiliation': 'Post Graduate Program of Physical Education, São Judas Tadeu University, São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Eduardo', 'Initials': 'PE', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Praia Grande College, Praia Grande, SP, Brazil.'}, {'ForeName': 'Roberta Luksevicius', 'Initials': 'RL', 'LastName': 'Rica', 'Affiliation': 'Department of Physical Education, Estácio de Sá University, Vitoria, ES, Brazil.'}, {'ForeName': 'Danilo Sales', 'Initials': 'DS', 'LastName': 'Bocalini', 'Affiliation': 'Experimental Physiology and Biochemistry Laboratory, Physical Education and Sport Center. Federal University of Espirito Santo, Vitoria, ES, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.013'] 1107,31079947,Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial.,"BACKGROUND ExPEC4V (JNJ-63871860) is a bioconjugate vaccine, containing O-antigens from Escherichia coli serotypes O1A, O2, O6A, and O25B, developed for the prevention of invasive extra-intestinal pathogenic E coli (ExPEC) disease. We aimed to assess safety, reactogenicity, and immunogenicity of ExPEC4V in healthy adults. METHODS In this phase 2 randomised, double-blind placebo-controlled study, we recruited healthy adults (≥18 years with a body-mass index of 35 kg/m 2 or less) between Nov 16, 2015, and Aug 8, 2017, and randomly assigned them to receive a single dose of ExPEC4V (antigen O1A:O2:O6A:O25B content 4:4:4:4 μg [group 1]; 4:4:4:8 μg [group 2], 8:8:8:8 μg [group 3], 8:8:8:16 μg [group 4], or 16:16:16:16 μg [group 5]) or placebo. The primary objectives were evaluation of the safety, tolerability, and immunogenicity of ExPEC4V and determination of its dose-dependent immunogenicity 15 days after vaccination by ELISA in individuals who had received at least one vaccination dose. Antibody titres and safety evaluation were used to select two ExPEC4V doses for assessment up to day 360. This trial is registered at ClinicalTrials.gov, number NCT02546960. FINDINGS Of 848 enrolled participants, 843 (99%) received the ExPEC4V vaccine (757) or placebo (86) and were included in the safety analysis. Of 757 participants vaccinated with ExPEC4V, 222 (29%) had a solicited local adverse event and 325 (43%) had any solicited systemic adverse event, compared with 11 (13%) and 30 (35%) of 86 participants in the control group. Symptoms were mild-to-moderate. The most frequently reported solicited local adverse event was pain or tenderness (205 [27·1%] of 757 in combined ExPEC4V groups) and the most frequently reported solicited systemic adverse event was fatigue (208 [27·6%] of 757). Only 13 (2%) of 843 had a grade 3 event. At day 15, 80% or more of all participants achieved a two times or greater increase in serotype-specific IgG antibodies (except O25B at the lowest dose, 103 [72%] of 144). At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline. INTERPRETATION EXPEC4V seemed well tolerated and elicited robust and functional antibody responses across all serotypes, doses, and age groups. For the two dosages evaluated (4:4:4:8 μg and 8:8:8:16 μg), the immune response persisted for 1 year. FUNDING Janssen Pharmaceuticals.",2019,"At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline. ","['848 enrolled participants, 843 (99%) received the', 'healthy adults', 'recruited healthy adults (≥18 years with a body-mass index of 35 kg/m 2 or less) between Nov 16, 2015, and Aug 8, 2017']","['ExPEC4V vaccine (757) or placebo', 'placebo', 'vaccine', 'ExPEC4V']","['safety, tolerability, and immunogenicity of ExPEC4V and determination of its dose-dependent immunogenicity 15 days after vaccination by ELISA', 'Safety and immunogenicity', 'Antibody titres and safety evaluation', 'solicited systemic adverse event', 'serotype-specific antibody', 'tolerated and elicited robust and functional antibody responses', 'solicited local adverse event', 'immune response', 'serotype-specific IgG antibodies', 'pain or tenderness', 'safety, reactogenicity, and immunogenicity of ExPEC4V']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}]",848.0,0.679939,"At day 360, 66% (95% CI 56·47-74·33) of participants in group 2 and 71% (62·13-78·95) of participants in group 4 selected for long-term follow-up maintained a two times or greater increase in serotype-specific antibody compared with baseline. ","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Frenck', 'Affiliation': ""Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: robert.frenck@cchmc.org.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ervin', 'Affiliation': 'Centre for Pharmaceutical Research, Kansas City, MO, USA.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Benchmark Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Abbanat', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Spiessens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Go', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Haazen', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Germie', 'Initials': 'G', 'LastName': 'van den Dobbelsteen', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Poolman', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Thoelen', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ibarra de Palacios', 'Affiliation': 'Janssen Vaccines, Clinical Development, Bern, Switzerland.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30803-X'] 1108,31733362,The Context of Values in Pain Control: Understanding the Price Effect in Placebo Analgesia.,"The experience of pain relief arises from physiological and psychological factors, and attributes such as the commercial features of analgesic treatments have been shown to influence placebo analgesia by affecting treatment expectations. Therefore, treatment valuation from price information should influence the placebo analgesic effect. This hypothesis was tested in a functional magnetic resonance imaging study in which healthy subjects were enrolled in a 2-day experiment. On day 1, the participants (n = 19) had treatment experiences with 2 different placebo creams during a conditioning session without receiving information on treatment price. On day 2, placebo analgesia was tested after providing price information (high vs low) while functional magnetic resonance imaging was performed. The results showed that the higher priced placebo treatment leads to enhanced pain relief. Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex, and ventral tegmental area. The behavioral results indicate that the experience of pain was influenced by treatment valuation from price. Our findings reveal that the context of values in pain control is associated with activity in expectation- and reward-related circuitry. PERSPECTIVE: Treatment with higher price was associated with enhanced placebo analgesia, and this effect was influenced by activities in expectation and reward processing brain areas. The context of value such as medical cost influences cognitive evaluation processes to modulate pain. Our study may help evaluate a patient's preference toward high-priced drugs.",2019,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.",['healthy subjects'],"['placebo', 'placebo analgesia', 'placebo creams', 'Placebo analgesia']","['pain relief', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.152627,"Placebo analgesia in response to the higher priced treatment was associated with activity in the ventral striatum, ventromedial prefrontal cortex and ventral tegmental area.","[{'ForeName': 'Ye-Seul', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam, South Korea.'}, {'ForeName': 'Won-Mo', 'Initials': 'WM', 'LastName': 'Jung', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Department of Neurology, Essen University Hospital, Essen, Germany.'}, {'ForeName': 'Younbyoung', 'Initials': 'Y', 'LastName': 'Chae', 'Affiliation': 'Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Department of Neurology, Essen University Hospital, Essen, Germany. Electronic address: ybchae@khu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.11.005'] 1109,31725142,Does tranexamic acid reduce mortality in women with postpartum hemorrhage?,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).",2019,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).",['women with postpartum hemorrhage'],['tranexamic acid'],['maternal mortality'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}]",,0.275637,"When used in conjunction with the standard of care, 1 g intravenous (IV) tranexamic acid given 1 to 3 hours after delivery is associated with a significant reduction in maternal mortality from postpartum hemorrhage (PPH) (strength of recommendation: A, randomized controlled trial [RCT] and Cochrane review).","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dresang', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kredit', 'Affiliation': 'University of Wisconsin Department of Family Medicine and Community Health, Madison, USA.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Vellardita', 'Affiliation': 'Ebling Library, University of Wisconsin, Madison, USA.'}]",The Journal of family practice,[] 1110,31493749,Examining motivational interviewing's effect on confidence and commitment using daily data.,"Mechanisms of behavior change (MOBC) within Motivational Interviewing (MI) are thought to operate via both relational and technical elements. These elements are hypothesized to increase client motivation and self-efficacy for change and subsequently decrease drinking. Only partial support for this causal chain exists, particularly when using within-session change talk as the primary intervening variable. This study explored whether commitment to moderate or abstain from drinking and confidence to moderate drinking in the next day measured via ecological momentary assessment (EMA) provided alternative support for the theory. Data were from a pilot randomized controlled trial testing active ingredients of MI. Problem drinkers (N = 89) seeking to moderate their drinking were randomly assigned to one of the three conditions: 1) MI; 2) Spirit only MI (SOMI), consisting of non-directive elements of MI, e.g., reflective listening; and 3) a non-therapy control. Participants completed daily EMA that measured confidence, both types of commitment, and drinks per day for a week prior to and during seven weeks of treatment. Hypotheses were not supported, and results were unexpected. Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment. All daily measures significantly predicted drinking; however, the MI group did not demonstrate a stronger relationship between the intervening variables and drinking, as hypothesized. Instead, participants in SOMI yielded the strongest relationship between daily commitment to abstain and drinking compared to the other two conditions. Multiple possible explanations for the unexpected findings are discussed.",2019,Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment.,['Problem drinkers (N\u202f=\u202f89) seeking to moderate their drinking'],"['Motivational Interviewing (MI', 'MI; 2) Spirit only MI (SOMI), consisting of non-directive elements of MI, e.g., reflective listening; and 3) a non-therapy control']",['client motivation and self-efficacy'],"[{'cui': 'C0687725', 'cui_str': 'Alcoholics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0206516,Participants in SOMI were more likely to have higher daily confidence than those in MI; there were no condition differences for either type of commitment.,"[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Kuerbis', 'Affiliation': 'Silberman School of Social Work, Hunter College at the City University of New York, New York, NY 10035, USA. Electronic address: ak1465@hunter.cuny.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Sijing', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, Great Neck, NY 11021, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Morgenstern', 'Affiliation': 'Center for Addiction Services and Personalized Interventions Research, Northwell Health, Great Neck, NY 11021, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.04.038'] 1111,31642352,A comparison of high versus low dose of exercise training in exercise-based cardiac rehabilitation: a randomized controlled trial with 12-months follow-up.,"OBJECTIVE To assess if a higher dose of exercise training in exercise-based cardiac rehabilitation could affect improvements in aerobic capacity and muscle strength. DESIGN Assessor-blinded randomized controlled trial with 12-months follow-up. SETTING Aarhus University Hospital, Aarhus, Denmark. SUBJECTS A total of 164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited. INTERVENTIONS Patients were randomized to 1-hour exercise sessions either three times weekly for 12 weeks (36 sessions, high-dose group) or twice weekly for 8 weeks (16 sessions, low-dose group). The same standardized exercise and intensity protocol including aerobic and muscle strength training was used in all participants. MAIN MEASURES Primary outcome was changes in VO 2peak . Secondary outcomes were changes in maximal workload, muscle strength and power. Measures were obtained at baseline, after termination of the rehabilitation programme and at follow-up after 6 and 12 months. RESULTS After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO 2peak 2.6 (mL kg -1  min -1 ) (95% confidence interval (CI): 0.4-4.8), maximal workload 0.3 W kg -1 (95%CI: 0.02-0.5), isometric muscle strength 0.7 N m kg -1 (95%CI: 0.1-1.2) and muscle power 0.3 W kg -1 (95%CI: 0.04-0.6). After 12 months, a significant between-group difference only persisted in VO 2peak and maximal workload. CONCLUSION A higher dose of exercise training had a small effect on all outcomes at termination of intervention. A long-term effect persisted in VO 2peak and maximal workload. Although the effect was small, it is an important finding because VO 2peak is the most important predictor of all-cause mortality in cardiac patients.",2020,"After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO 2peak 2.6 (mL kg -1  min -1 ) (95% confidence interval (CI): 0.4-4.8), maximal workload 0.3 W kg -1 (95%CI: 0.02-0.5), isometric muscle strength 0.7 N m kg -1 (95%CI: 0.1-1.2) and muscle power 0.3 W kg -1 (95%CI: 0.04-0.6).","['164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited', 'Aarhus University Hospital, Aarhus, Denmark', 'cardiac patients', 'exercise-based cardiac rehabilitation']","['standardized exercise and intensity protocol including aerobic and muscle strength training', 'exercise training']","['changes in VO 2peak ', 'changes in maximal workload, muscle strength and power', 'VO 2peak and maximal workload', 'aerobic capacity and muscle strength', 'isometric muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.153851,"After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO 2peak 2.6 (mL kg -1  min -1 ) (95% confidence interval (CI): 0.4-4.8), maximal workload 0.3 W kg -1 (95%CI: 0.02-0.5), isometric muscle strength 0.7 N m kg -1 (95%CI: 0.1-1.2) and muscle power 0.3 W kg -1 (95%CI: 0.04-0.6).","[{'ForeName': 'Annemette Krintel', 'Initials': 'AK', 'LastName': 'Petersen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lisa Gregersen', 'Initials': 'LG', 'LastName': 'Oestergaard', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'van Tulder', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sussie', 'Initials': 'S', 'LastName': 'Laustsen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215519883411'] 1112,31563388,Effect of one session of tDCS on the severity of pain in women with chronic pelvic pain.,"AIM The present study aimed to investigate the effects of tDCS on pain score in women with Chronic Pelvic Pain (CPP). MATERIALS & METHODS A total of 16 women with CPP participated in the present double-blind sham-controlled cross-over study. Each participant received a 20-min 0.3 MA of trans Cranial Direct Stimulation (tDCS) with a current density of 0.1 mA/cm 2 . In addition to the pain intensity, the Quality of Life (QOL), disability, and depression statuses were assessed prior to and one week after the treatment. Shapiro-Wilks goodness-of-fit test for normality, dependent t-Test, and Wilcoxon Signed- Rank Test were used for data analysis. Values of p < .05 were considered statistically significant. FINDINGS Active tDCS treatment was effective in the reduction of pain (p = .0001), improving QOL (208.938 > 193.313, P = .025), and the disability (22.375 < 30.375, P = .025). The results showed no effect of active or sham treatment on the depression (p ≥ .05). CONCLUSION The positive effects of active tDCS on CPP suggest the need to study the effect of this method on other types of chronic pain.",2019,"FINDINGS Active tDCS treatment was effective in the reduction of pain (p = .0001), improving QOL (208.938 > 193.313, P = .025), and the disability (22.375 < 30.375, P = .025).","['women with Chronic Pelvic Pain (CPP', '16 women with CPP participated in the present double-blind sham-controlled cross-over study', 'women with chronic pelvic pain']","['20-min 0.3\u202fMA of trans Cranial Direct Stimulation (tDCS', 'tDCS']","['pain score', 'disability', 'reduction of pain', 'pain intensity, the Quality of Life (QOL), disability, and depression statuses', 'QOL', 'severity of pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.136668,"FINDINGS Active tDCS treatment was effective in the reduction of pain (p = .0001), improving QOL (208.938 > 193.313, P = .025), and the disability (22.375 < 30.375, P = .025).","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Divandari', 'Affiliation': 'Physiotherapy Department, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: divandarinahid@yahoo.com.'}, {'ForeName': 'Farideh Dehghan', 'Initials': 'FD', 'LastName': 'Manshadi', 'Affiliation': 'Physiotherapy Department, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: manshadi@sbmu.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Shokouhi', 'Affiliation': 'Yas Women Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: nshokouhi@sina.tums.ac.ir.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Vakili', 'Affiliation': 'School of Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: vakilimahdi333@yahoo.com.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Physiotherapy Department, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. Electronic address: shapour.jaberzadeh@monash.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2017.12.014'] 1113,29343088,Creating and testing regulatory focus messages to enhance medication adherence.,"OBJECTIVES Strategies were explored to improve patient adherence to cardioprotective medications by borrowing from a motivational framework used in psychology, regulatory focus theory. The current study is part of a larger randomized control trial and was aimed at understanding what written educational messages, based on patients' regulatory focus tendency, resonated with each individual as a potential reminder to take medications. This study was also aimed at understanding why messages resonated with the patients. METHODS Twenty veterans were tested for regulatory fitand presented with messages dependent on focus tendency. In-person semi-structured interviews were conducted to collect feedback of messages. An iterative analysis drawing primarily on matrix and reflexive team analyses was conducted. RESULT Six promotion and six prevention messages emerged, such as ""team up with your provider to create a combination of medications to prevent illness"" and ""Live your best life - Take your medications"". Five themes related to types of health messages that spoke to patients' regulatory fit were discovered: relatability; empowerment and control; philosophy on life; relationship with provider and medications; and vocabulary effect on the impact of messages. DISCUSSION Motivational messages based on regulatory fit may be useful in improving patient medication adherence, leading to improved cardiovascular outcomes.",2019,"Five themes related to types of health messages that spoke to patients' regulatory fit were discovered: relatability; empowerment and control; philosophy on life; relationship with provider and medications; and vocabulary effect on the impact of messages. ",['Twenty veterans were tested for regulatory fitand presented with messages dependent on focus tendency'],[],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]",[],[],20.0,0.0202934,"Five themes related to types of health messages that spoke to patients' regulatory fit were discovered: relatability; empowerment and control; philosophy on life; relationship with provider and medications; and vocabulary effect on the impact of messages. ","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': ""O'Connor"", 'Affiliation': '1 20004 Iowa City VA Health Care System , Iowa City, IA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ladebue', 'Affiliation': '2 19982 VA Eastern Colorado Health Care System , Denver, CO, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': '2 19982 VA Eastern Colorado Health Care System , Denver, CO, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Davis', 'Affiliation': '2 19982 VA Eastern Colorado Health Care System , Denver, CO, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jung Grant', 'Affiliation': '3 Questrom School of Business, Boston University, Boston, MA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'McCreight', 'Affiliation': '2 19982 VA Eastern Colorado Health Care System , Denver, CO, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lambert-Kerzner', 'Affiliation': '2 19982 VA Eastern Colorado Health Care System , Denver, CO, USA.'}]",Chronic illness,['10.1177/1742395317753882'] 1114,31735969,Weight Loss Intervention Impact on the Physical Fitness Test Scores of Air Force Service Members.,"INTRODUCTION Overweight and obesity are a major public health concern in the United States, including among active duty military personnel. Approximately 51% of active duty personnel are classified as overweight and 15% are classified as obese. This may impact military readiness. The current study aimed to determine if a weight loss intervention impacted fitness test scores among Air Force personnel. MATERIALS AND METHODS From 2014 to 2016, 204 Air Force members with overweight/obesity were randomized into either a Self-paced or counselor-initiated arm in a weight loss program. Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Fitness test scores from before, during, and after the intervention were used to determine if the intervention resulted in improvements in overall fitness test ratings and scores on individual components of the test. RESULTS Participants who lost at least 5% of their weight had better fitness ratings during the intervention compared to individuals who did not lose 5%. However, in the overall sample, fitness ratings worsened from preintervention to during the intervention, and from during to postintervention. Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. CONCLUSIONS Behavioral weight management interventions that achieve 5% weight loss may help improve military fitness test ratings.",2020,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. ","['Participants with overweight', 'From 2014 to 2016, 204 Air Force members with overweight/obesity', 'Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center']","['weight loss intervention', 'Self-paced or counselor-initiated arm in a weight loss program']","['abdominal circumference scores and better fitness test ratings preintervention', 'fitness ratings', 'overall fitness test ratings and scores on individual components of the test', 'military fitness test ratings']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]",204.0,0.022092,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity. ","[{'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Pebley', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beauvais', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Lackland Air Force Base, San Antonio, TX.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Gladney', 'Affiliation': 'Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Robert C Klesges', 'Initials': 'RCK', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hare', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hryshko-Mullen', 'Affiliation': 'Department of Mental Health, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland AFB, San Antonio, TX.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}]",Military medicine,['10.1093/milmed/usz371'] 1115,31056229,"Reply to Satoru Taguchi, Tohru Nakagawa, and Hiroshi Fukuhara's Letter to the Editor re: Jürgen E. Gschwend, Matthias M. Heck, Jan Lehmann, et al. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol 2019;75:604-11.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.0392024,,"[{'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany. Electronic address: juergen.gschwend@tum.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany.'}]",European urology,['10.1016/j.eururo.2019.04.032'] 1116,31056427,"CAL02, a novel antitoxin liposomal agent, in severe pneumococcal pneumonia: a first-in-human, double-blind, placebo-controlled, randomised trial.","BACKGROUND Severe community-acquired pneumonia caused by Streptococcus pneumoniae is associated with high morbidity and mortality rates. CAL02, a novel antitoxin agent with an unprecedented mode of action, consists of liposomes that capture bacterial toxins known to dysregulate inflammation, cause organ damage, and impede immune defence. We aimed to assess the safety of CAL02 as an add-on therapy to antibiotics. METHODS This randomised, double-blind, multicentre, placebo-controlled trial was done in ten intensive care units (ICUs) in France and Belgium (but only six units enrolled patients), in patients with severe community-acquired pneumococcal pneumonia who required ICU admission and had been identified as being infected with S pneumoniae. We randomly assigned participants in two stages-the first stage randomly assigned six patients (1:1) to either low-dose CAL02 or placebo, and the second stage randomly assigned 18 patients (14:4) to either high-dose CAL02 or placebo, and stratified in four blocks (4:1, 4:1, 3:1, and 3:1), in addition to standard of care. Block randomisation was done with a computer-generated random number list. Participants, investigators, other site study personnel, the sponsor, and the sponsor's designees involved in study management and monitoring were masked to the randomisation list and treatment assignment. Patients were treated with low-dose (4 mg/kg) or high-dose (16 mg/kg) CAL02 or placebo (saline), in addition to standard antibiotic therapy. Two intravenous doses of study treatment were infused, with a 24 h interval, at a concentration of 10 mg/mL, stepwise, over a maximum of 2 h on days 1 and 2. The primary objective of the study was to assess the safety and tolerability of low-dose and high-dose CAL02 in patients with severe community-acquired pneumonia treated with standard antibiotic therapy, and the primary analysis was done on the safety population (all patients who received at least one dose of the study treatment). Efficacy was a secondary outcome. This trial is registered with ClinicalTrials.gov, number NCT02583373. FINDINGS Between March 21, 2016, and Jan 13, 2018, we screened 280 patients with community-acquired pneumonia. 19 patients were enrolled and randomly assigned, resulting in 13 patients in the CAL02 groups (three assigned to low-dose CAL02 and ten assigned to high-dose CAL02) and six in the placebo group. One patient randomly assigned to placebo was allocated to the wrong treatment group and received high-dose CAL02 instead of placebo. Thus, 14 patients received CAL02 (three received low-dose CAL02 and 11 received high-dose CAL02) and five patients received placebo, constituting the safety population. At baseline, the mean APACHE II score for the total study population was 21·5 (SD 4·9; 95% CI 19·3-23·7) and 11 (58%) of 19 patients had septic shock. Adverse events occurred in 12 (86%) of 14 patients in the CAL02 treatment groups combined and all five (100%) patients in the placebo group. Serious adverse events occurred in four (29%) of 14 patients in the CAL02 treatment groups combined and two (40%) of five patients in the placebo group. One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug. However, analysis of the changes in triglyceride levels in the CAL02 groups compared with the placebo group revealed no correlation with administration of CAL02. No adverse events were linked to local tolerability events. All patients, apart from one who died in the low CAL02 group (death not related to the study drug) achieved clinical cure at the test of cure visit between days 15 and 22. The sequential organ failure assessment score decreased by mean 65·0% (95% CI 50·7-79·4) in the combined CAL02 groups compared with 29·2% (12·8-45·5) in the placebo group between baseline and day 8. INTERPRETATION The nature of adverse events was consistent with the profile of the study population and CAL02 showed a promising safety profile and tolerability. However, the difference between high-dose and low-dose CAL02 could not be assessed in this study. Efficacy was in line with the expected benefits of neutralising toxins. The results of this study support further clinical development of CAL02 and provide a solid basis for a larger clinical study. FUNDING Combioxin.",2019,One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug.,"['280 patients with community-acquired pneumonia', 'severe pneumococcal pneumonia', '19 patients', 'ten intensive care units (ICUs) in France and Belgium (but only six units enrolled patients), in patients with severe community-acquired pneumococcal pneumonia who required ICU admission and had been identified as being infected with S pneumoniae', '14 patients received', 'patients with severe community-acquired pneumonia treated with standard antibiotic therapy, and the primary analysis was done on the safety population (all patients who received at least one dose of the study treatment']","['CAL02 (three received low-dose CAL02 and 11 received high-dose CAL02', 'placebo', 'low-dose CAL02 and ten assigned to high-dose CAL02', 'CAL02 or placebo (saline', 'low-dose and high-dose CAL02', 'CAL02', 'high-dose CAL02 instead of placebo', 'low-dose CAL02 or placebo', 'high-dose CAL02 or placebo']","['Efficacy', 'triglycerides', 'safety profile and tolerability', 'Adverse events', 'safety and tolerability', 'sequential organ failure assessment score', 'septic shock', 'triglyceride levels', 'clinical cure', 'Serious adverse events', 'mean APACHE II score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0155862', 'cui_str': 'Pneumonia, Pneumococcal'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}]",19.0,0.704638,One non-serious adverse event (mild increase in triglycerides) in a patient in the high-dose CAL02 group was reported as related to study drug.,"[{'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Intensive Care Unit, Cliniques Universitaires Saint-Luc, Université catholique de Louvain (UCL), Brussels, Belgium. Electronic address: pierre-francois.laterre@uclouvain.be.'}, {'ForeName': 'Gwenhael', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, District Hospital Center, La Roche-sur-Yon, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': 'Medical-Surgical Intensive Care Unit, University Hospital, Tours, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'Soins Intensifs, Clinique Saint-Pierre, Ottignies, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Boulain', 'Affiliation': ""Service de Médecine Intensive Réanimation, Hôpital La Source, Centre Hospitalier Régional d'Orléans, Orléans, France.""}, {'ForeName': 'Samareh', 'Initials': 'S', 'LastName': 'Azeredo da Silveira', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lajaunias', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Combioxin, Geneva, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical Intensive Care Unit, University Hospital Limoges Dupuytren Hospital, Limoges, France; Inserm CIC-1435, University Hospital Limoges Dupuytren Hospital, Limoges, France; Inserm UMR 1092, Faculté de Médecine, Université de Limoges, Limoges, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30805-3'] 1117,31045231,Modulation of Adaptive Cognitive Control by Prefrontal High-Definition Transcranial Direct Current Stimulation in Older Adults.,"OBJECTIVE Adaptive cognitive control frequently declines in advanced age. Because high-definition transcranial direct current stimulation (HD-tDCS) of the right dorsolateral prefrontal cortex (DLPFC) improved cognitive control in young adults, we investigated if this montage can also improve cognitive control in older individuals. METHOD In a double-blind, sham HD-tDCS controlled, cross-over design, 36 older participants received right DLPFC HD-tDCS during a visual flanker task. Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control. Biophysical modeling assessed the magnitude and distribution of induced current in older adults. RESULTS Active HD-tDCS enhanced CA in older adults. However, this positive behavioral effect was limited to CA in ER. Similar to results obtained in healthy young adults, current modeling analysis demonstrated focal current delivery to the DLPFC with sufficient magnitude of the induced current to modulate neural function in older adults. DISCUSSION This study confirms the effectiveness of HD-tDCS to modulate adaptive cognitive control in advanced age.",2019,Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control.,"['young adults', 'advanced age', 'older adults', 'older individuals', 'healthy young adults', '36 older participants received']","['adaptive cognitive control by prefrontal high definition transcranial direct current stimulation', 'transcranial direct current stimulation (HD-tDCS', 'right DLPFC HD-tDCS', 'HD-tDCS', 'Conflict adaptation (CA']",['response time (RT) and error rates (ER) assessed adaptive cognitive control'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",36.0,0.0364496,Conflict adaptation (CA) effects on response time (RT) and error rates (ER) assessed adaptive cognitive control.,"[{'ForeName': 'Oyetunde', 'Initials': 'O', 'LastName': 'Gbadeyan', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Steinhauser', 'Affiliation': 'Department of Psychology, Catholic University of Eichstätt-Ingolstadt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hunold', 'Affiliation': 'Institute of Biomedical Engineering and Informatics, Technical University Ilmenau, Germany.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haueisen', 'Affiliation': 'Institute of Biomedical Engineering and Informatics, Technical University Ilmenau, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'Centre for Clinical Research, The University of Queensland, Brisbane, Australia.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz048'] 1118,31628791,Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial.,"BACKGROUND Mindfulness-based cognitive therapy (MBCT) is an evidence-based group-based psychological treatment in oncology, resulting in reduction of depressive and anxiety symptoms. Internet-based MBCT (eMBCT) has been found to be an effective alternative for MBCT. The therapeutic alliance (the bond between therapist and patient,) is known to have a significant impact on psychological treatment outcomes, including MBCT. A primary concern in the practice of eMBCT is whether a good therapeutic alliance can develop. Although evidence for the beneficial effect of therapist assistance on treatment outcome in internet-based interventions (IBIs) is accumulating, it is still unclear whether the therapeutic alliance is related to outcome in IBIs. OBJECTIVE This study aimed to (1) explore whether early therapeutic alliance predicts treatment dropout in MBCT or eMBCT, (2) compare the development of the therapeutic alliance during eMBCT and MBCT, and (3) examine whether early therapeutic alliance is a predictor of the reduction of psychological distress and the increase of mental well-being at posttreatment in both conditions. METHODS This study was part of a multicenter randomized controlled trial (n=245) on the effectiveness of MBCT or eMBCT for distressed cancer patients. The therapeutic alliance was measured at the start of week 2 (ie, early therapeutic alliance), week 5, and week 9. Outcome measures were psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form. RESULTS The strength of early therapeutic alliance did not predict treatment dropout in MBCT or eMBCT (B=-.39; P=.21). Therapeutic alliance increased over time in both conditions (F 2,90 =16.46; Wilks λ=0.732; P<.001). This increase did not differ between eMBCT and MBCT (F 1,91 =0.114; P=.74). Therapeutic alliance at week 2 predicted a decrease in psychological distress (B=-.12; t 114 =-2.656; P=.01) and an increase in mental well-being (B=.23; t 113 =2.651; P=.01) at posttreatment. The relationship with reduction of psychological distress differed between treatments: a weaker early therapeutic alliance predicted higher psychological distress at posttreatment in MBCT but not in eMBCT (B=.22; t 113 =2.261; P=.03). CONCLUSIONS A therapeutic alliance can develop in both eMBCT and MBCT. Findings revealed that the strength of early alliance did not predict treatment dropout. Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions. Interestingly, the strength of therapeutic alliance appeared to be more related to treatment outcome in group-based MBCT than in eMBCT. TRIAL REGISTRATION ClinicalTrials.gov NCT02138513; https://clinicaltrials.gov/ct2/show/NCT02138513.",2019,"Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions.","['Distressed Cancer Patients', 'distressed cancer patients']","['Mindfulness-based cognitive therapy (MBCT', 'therapist assistance', 'Internet-based MBCT (eMBCT', 'Internet-Based Mindfulness-Based Cognitive Therapy', 'MBCT or eMBCT']","['Therapeutic alliance', 'strength of therapeutic alliance', 'psychological distress', 'strength of early alliance', 'strength of early therapeutic alliance', 'therapeutic alliance', 'psychological distress, measured with the Hospital Anxiety and Depression Scale, and mental well-being, measured with the Mental Health Continuum-Short Form']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0638798,"Furthermore, the level of therapeutic alliance predicted reduced psychological distress and increased mental well-being at posttreatment in both conditions.","[{'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Bisseling', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schellekens', 'Affiliation': 'Helen Dowling Institute, Centre for Psycho-Oncology, Scientific Research Department, Bilthoven, Netherlands.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Compen', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van der Lee', 'Affiliation': 'Helen Dowling Institute, Centre for Psycho-Oncology, Scientific Research Department, Bilthoven, Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Speckens', 'Affiliation': 'Radboudumc for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/14065'] 1119,31724261,Feasibility and acceptability of i-Restoring Body Image after Cancer (i-ReBIC): A pilot trial for female cancer survivors.,"OBJECTIVE This pilot study aimed to evaluate the feasibility, acceptability, and psychosocial outcomes of a text-based online group therapy intervention, i-Restoring Body Image after Cancer (i-ReBIC). i-ReBIC was developed to reduce body image distress and psychosexual dysfunction among women diagnosed and treated for breast or gynecological cancer. METHODS i-ReBIC was adapted from an empirically tested face-to-face group therapy intervention, ReBIC. Over the 8-week intervention, participants engaged in 90-minute weekly text-based online discussions. Each week, a new topic associated with reconnecting to the body, adjusting to a postcancer identity, and improving psychosexual functioning was addressed. Homework assignments included readings, guided imagery exercises, and journaling. RESULTS Sixty women with cancer enrolled in the pilot study. Among them, 47 completed the intervention, and 44 filled out all prestudy and poststudy questionnaires. Ninety-three percent of participants (n = 41) were satisfied and reported that it met their expectations. Eighty percent of participants (n = 35) reported no technical difficulties during the intervention. Preoutcome and postoutcome measures on body image distress and experience of embodiment showed statistically significant improvements. Psychosexual distress and quality of life also showed improvements but were not statistically significant. CONCLUSIONS This study suggests that i-ReBIC is feasible, well accepted, and effective in addressing persistent body image concerns experienced by women treated for breast or gynecological cancer. As an online group therapy, i-ReBIC can expand the reach of its original face-to-face intervention by mitigating barriers and improving access to care in a cost-effective manner.",2020,"Psychosexual distress and quality of life also showed improvements but were not statistically significant. ","['after Cancer (i-ReBIC', 'women diagnosed and treated for breast or gynecological cancer', 'Sixty women with cancer enrolled in the pilot study', 'women treated for breast or gynecological cancer', 'female cancer survivors']","['guided imagery exercises, and journaling', 'text-based online group therapy intervention', 'i-Restoring Body Image']","['body image distress and psychosexual dysfunction', 'feasibility, acceptability, and psychosocial outcomes', 'Psychosexual distress and quality of life', 'body image distress and experience of embodiment', 'technical difficulties']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3714744', 'cui_str': 'Psychosexual dysfunction (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034380'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",60.0,0.0419779,"Psychosexual distress and quality of life also showed improvements but were not statistically significant. ","[{'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Trachtenberg', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'de Souza Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rennie', 'Affiliation': 'Leap of Faith Counselling, Surrey, British Columbia, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McLeod', 'Affiliation': 'de Souza Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Leung', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Warner', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Esplen', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Psycho-oncology,['10.1002/pon.5288'] 1120,31853609,Randomized Trial of Deep Vein Thrombosis Chemoprophylaxis with Bemiparin and Enoxaparin in Patients with Moderate to High Thrombogenic Risk Undergoing Plastic and Reconstructive Surgery Procedures.,"BACKGROUND Deep vein thrombosis (DVT) is a common complication during postoperative convalescence characterized by hypercoagulability, vascular endothelium damage and blood stasis. It increases noticeably in peri/postoperative phases of surgery procedures. Pulmonary embolism secondary to iliofemoral DVT is a frequent cause of death. METHODS Adult patients scheduled for plastic and reconstructive surgery (PRSx) with moderate to high thrombogenic risk were selected. We evaluated the efficacy and safety of bemiparin compared to enoxaparin as chemoprophylaxis for DVT. Following balanced general anesthesia techniques, patients were randomly assigned for subcutaneous enoxaparin 40 IU (Group-E) or bemiparin 3500 IU (Group-B) q24h starting 6 h after procedure conclusion for at least 10 days. All patients were evaluated for DVT through Doppler ultrasound mapping of the lower limbs. RESULTS Seventy-eight patients were evaluated, mostly women (83%), physical status ASA II (59%), ASA III (10%); Caprini's thrombogenic risk score 3-4 (moderate) 58%, 5-6 (high) 29%, > 6 (too high) 13%; demographics, clinical variables and scores were similar between groups. Median drainage time in breast surgery was 4 days in both groups (p = 0.238). In the case of abdominal surgery, median was 14 days in Group-E versus 13 days in Group-B (p = 0.059). No DVT was detected in either group. CONCLUSIONS DVT was prevented with bemiparin, without significant bleeding increase nor adverse events; moreover, the cost of bemiparin is lower than enoxaparin. Bemiparin can be considered as alternative drug for DVT chemoprophylaxis in PRSx procedures. LEVEL OF EVIDENCE III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,Median drainage time in breast surgery was 4 days in both groups (p = 0.238).,"['Adult patients scheduled for plastic and reconstructive surgery (PRSx) with moderate to high thrombogenic risk were selected', 'Patients with Moderate to High Thrombogenic Risk Undergoing Plastic and Reconstructive Surgery Procedures']","['enoxaparin', 'bemiparin', 'Deep Vein Thrombosis Chemoprophylaxis with Bemiparin and Enoxaparin', 'subcutaneous enoxaparin 40\xa0IU (Group-E) or bemiparin 3500\xa0IU']","['Median drainage time', ""Caprini's thrombogenic risk score"", 'efficacy and safety', 'physical status ASA', 'DVT', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0916062', 'cui_str': 'bemiparin'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C4517736', 'cui_str': '3500'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.068905,Median drainage time in breast surgery was 4 days in both groups (p = 0.238).,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Revilla-Peñaloza', 'Affiliation': 'Anesthesiology Service, American British Cowdray Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Del. Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Paul Jay', 'Initials': 'PJ', 'LastName': 'Olsoff-Pagovich', 'Affiliation': 'Plastic and Reconstructive Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Ochoa-Gomez', 'Affiliation': 'Plastic and Reconstructive Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castaneda-Gaxiola', 'Affiliation': 'Angiology and Vascular Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Ángel Iván', 'Initials': 'ÁI', 'LastName': 'Rubio-Gayosso', 'Affiliation': 'Sección de Estudios de posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Plan de San Luis y Díaz Mirón, CP 11340, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Sección de Estudios de posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Plan de San Luis y Díaz Mirón, CP 11340, Mexico City, Mexico.'}, {'ForeName': 'Juan Arcadio', 'Initials': 'JA', 'LastName': 'Molina-Guarneros', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, National Autonomous University of Mexico, Av. Universidad No. 3000, Colonia Ciudad Universitaria, CP 04510, Alcaldía Coyoacan, Mexico City, Mexico. jamg@unam.mx.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01573-5'] 1121,31721026,"Effects of Metformin on Left Ventricular Size and Function in Hypertensive Patients with Type 2 Diabetes Mellitus: Results of a Randomized, Controlled, Multicenter, Phase IV Trial.","BACKGROUND Metformin is the most widely used oral antihyperglycemic agent for patients with type 2 diabetes mellitus (T2DM). Despite the possible benefits of metformin on diabetes mellitus (DM) and heart failure (HF), acute or unstable HF remains a precaution for its use. OBJECTIVE The aim of the present prospective randomized controlled trial was to assess whether metformin treatment has beneficial effects on patients with T2DM with hypertension without overt HF. METHODS A total of 164 patients (92 males, 72 females; median age 66 years) were included in this study. Patients with T2DM with a history of hypertension were randomized 1:1 to treatment for 1 year with either metformin (metformin-treated group) or other hypoglycemic agents (control group). The primary endpoints were changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function. We also evaluated changes in both clinical findings and blood laboratory examination data. RESULTS We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups. The metformin-treated group had a significant reduction of body mass index (BMI) and low-density lipoprotein cholesterol (LDL-C), but the control group did not. We determined that renal function, including serum creatinine and estimated glomerular filtration rate, deteriorated significantly in the control group but not in the metformin-treated group. CONCLUSION LV mass and diastolic function were not affected after 1 year of metformin treatment in patients with T2DM. However, we observed benefits in terms of reductions in both BMI and LDL-C levels and preservation of renal function. TRIAL REGISTRATION UMIN000006504. Registered 7 October 2011.",2020,"We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups.","['patients with T2DM with hypertension without overt HF.\nMETHODS\n\n\nA total of 164 patients (92 males, 72 females; median age 66\xa0years', 'Patients with T2DM with a history of hypertension', 'patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'Hypertensive Patients with Type 2 Diabetes Mellitus']","['metformin (metformin-treated group) or other hypoglycemic agents (control group', 'metformin', 'Metformin']","[""LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function"", 'body mass index (BMI) and low-density lipoprotein cholesterol (LDL-C', 'LV mass and diastolic function', 'changes in brain natriuretic peptide (BNP) levels, left ventricular (LV) mass index, and indicators of LV diastolic function', 'renal function, including serum creatinine and estimated glomerular filtration rate', 'Left Ventricular Size and Function', 'diabetes mellitus (DM) and heart failure (HF', 'BMI and LDL-C levels and preservation of renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",164.0,0.0466242,"We observed no significant changes between baseline and 1-year post-treatment in LV mass index, BNP levels, or E/e' (early diastolic transmitral flow velocity/early diastolic mitral annular velocity; an indicator of LV diastolic function) in either the metformin-treated (n = 83) or the control (n = 81) groups.","[{'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Ono', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan. kohono@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Wada', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Satoh-Asahara', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Hitoki', 'Initials': 'H', 'LastName': 'Inoue', 'Affiliation': 'Department of Cardiology, National Hospital Organization Hokkaido Cancer Center, 2-3-54, Kikusuishijyo, Shiraishi-ku, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Uehara', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Tochigi Medical Center, 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, 3208580, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Funada', 'Affiliation': 'Department of Cardiology, National Hospital Organization Ehime Medical Center, 366 Yokogawara, Toon, Ehime, 791-0281, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ogo', 'Affiliation': 'Department of Metabolism and Endocrinology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Horie', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiovascular Medicine, Uji Hospital, Uji, Kyoto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00381-1'] 1122,30983087,Impact of low-dose prasugrel on platelet reactivity and cardiac dysfunction in acute coronary syndrome patients requiring primary drug-eluting stent implantation: A randomized comparative study.,"OBJECTIVE The aim of this study was to compare how prasugrel and clopidogrel affect platelet aggregation reactivity, cardiac enzyme release, cardiac remodeling, and the formation of in-stent thrombi after primary percutaneous coronary intervention (PCI). BACKGROUND The advantages of using prasugrel over clopidogrel in cardiac injury following acute coronary syndrome (ACS) remain unclear. METHODS A total of 78 ACS patients were randomly allocated into clopidogrel (300 mg loading/75 mg maintenance) or prasugrel (20 mg loading/3.75 mg maintenance) treatment groups, followed by undergoing primary PCI. Platelet reactivity and cardiac enzymes were measured before and after primary PCI. Moreover, cardiac function was measured by ultrasound echocardiography and coronary angioscopic observation was after primary PCI up to 8 months later. RESULTS Antiplatelet reactivity in the prasugrel treatment group reached optimal levels (P2Y 12 reaction units [PRU] less than 262) immediately after the administration and was maintained even at 8 months, independently of the CYP2C19 genotype. Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061). There were no significant differences in the incidence of in-stent attached thrombi between the two groups. CONCLUSIONS Compared to clopidogrel, prasugrel produced a stable platelet aggregation inhibitory effect in patients with ACS regardless of CYP2C19 genotype, reduced cardiac enzyme release, and prevented cardiac remodeling after ACS.",2020,"Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061).","['cardiac injury following acute coronary syndrome (ACS', '78 ACS patients', 'acute coronary syndrome patients requiring primary drug-eluting stent implantation']","['prasugrel and clopidogrel', 'prasugrel over clopidogrel', 'low-dose prasugrel', 'Prasugrel', 'prasugrel', 'clopidogrel, prasugrel', 'clopidogrel']","['platelet reactivity and cardiac dysfunction', 'Platelet reactivity and cardiac enzymes', 'left ventricular mass', 'cardiac remodeling', 'cardiac function', 'incidence of in-stent attached thrombi', 'creatine kinase elevation']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",78.0,0.0449686,"Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kitano', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadateru', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Fukamachi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Migita', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Morikawa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Tamaki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mineki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Murata', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naotaka', 'Initials': 'N', 'LastName': 'Akutsu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Sudo', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hiro', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28277'] 1123,31562889,Clinical and OCT outcomes of a universal adhesive in a randomized clinical trial after 12 months.,"OBJECTIVES To assess the performance of a universal adhesive in different application modes in non-carious cervical lesions clinically and by optical coherence tomography (OCT). METHODS 55 adult patients with three non-carious cervical lesions (NCCL) each participated in the study. Lesions were restored with Scotchbond™ Universal (SBU, 3 M) applied in the self-etch (SBU-SE) and the selective-enamel-etch mode (SBU-SEE) in combination with Filtek™ Supreme XTE (3 M). OptiBond™ FL (OFL, Kerr) was used as a control. Restorations were clinically assessed (FDI criteria) after 14 days, 6 and 12 months and in parallel imaged by OCT (interfacial adhesive defects), starting immediately after filling placement. Cumulative failure rates (CFR) and means of interfacial adhesive defect were statistically evaluated. RESULTS After 12 months, CFRs were lower in the SBU groups (0.0% each) than in the OFL group (20.0%, p = 0.001). Clinically, small marginal fractures occurred three times more often in the SBU-SE than in the SBU-SEE group (p = 0.001). Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i ≤ 0.044). At dentin/cement more defects were seen with OFL compared to SBU/SE and SBU/SEE (p i ≤ 0.001). Before restoration loss, more interfacial defects appeared compared to remaining restorations (p immediately/6M  = 0.132/0.002). CONCLUSIONS Clinical evaluation and OCT imaging revealed higher interfacial integrity for SBU in both application modes compared to OFL. OCT detected interfacial bond failures prior to clinical deterioration or restoration loss. CLINICAL SIGNIFICANCE Scotchbond Universal showed an equivalent or improved bonding performance compared to the reference adhesive. Selective enamel etching is recommended. The parameter interfacial adhesive defect seems to be a valuable predictor for evaluation of adhesive restoration systems.",2019,Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i ≤ 0.044).,['55 adult patients with three non-carious cervical lesions (NCCL) each participated in the study'],['OFL'],"['bonding performance', 'interfacial defects', 'CFRs', 'small marginal fractures', 'OptiBond TM FL (OFL, Kerr', 'Cumulative failure rates (CFR) and means of interfacial adhesive defect']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0296330', 'cui_str': 'Optibond'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]",55.0,0.0371188,Immediately after filling placement and at each reassessment OCT revealed more interfacial defects at enamel interfaces for SBU/SE compared to SBU/SEE and OFL (p i ≤ 0.044).,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Haak', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: rainer.haak@medizin.uni-leipzig.de.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hähnel', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: marcus.haehnel@medizin.uni-leipzig.de.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: hartmut.schneider@medizin.uni-leipzig.de.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Rosolowski', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Härtelstraße 16-18, 04107 Leipzig, University of Leipzig, Germany. Electronic address: maciej.rosolowski@medizin.uni-leipzig.de.'}, {'ForeName': 'Kyung-Jin', 'Initials': 'KJ', 'LastName': 'Park', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: kyung-jin.park@medizin.uni-leipzig.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ziebolz', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: dirk.ziebolz@medizin.uni-leipzig.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Häfer', 'Affiliation': 'Department of Cariology, Endodontology and Periodontology, University of Leipzig, Liebigstraße 12, 04103 Leipzig, Germany. Electronic address: matthias.haefer@medizin.uni-leipzig.de.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103200'] 1124,30987814,Chlorhexidine for meatal cleaning in reducing catheter-associated urinary tract infections: a multicentre stepped-wedge randomised controlled trial.,"BACKGROUND Evidence for the benefits of antiseptic meatal cleaning in reducing catheter-associated urinary tract infection (UTI) is inconclusive. We assessed the efficacy of 0·1% chlorhexidine solution compared with normal saline for meatal cleaning before urinary catheter insertion in reducing the incidence of catheter-associated asymptomatic bacteriuria and UTI. METHODS A cross-sectional, stepped-wedge, open-label, randomised controlled trial was undertaken in Australian hospitals. Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30 000 hospital admissions per year. Hospitals were randomly assigned to an intervention crossover date using a computer-generated randomisation system. Crossover dates occurred every 8 weeks; during the first 8 weeks of the study, no hospitals were exposed to the intervention (control phase), after which each hospital sequentially crossed over from the control to the intervention every 8 weeks. Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study. Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI. The intervention was the use of 0·1% chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline used in the control phase. Masking of hospitals was not possible because it was not feasible to mask staff administering the intervention. The co-primary outcomes were the number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days and were assessed within 7 days of catheter insertion in the intention-to-treat population. This trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12617000373370. FINDINGS 21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled and randomised to one of three intervention crossover dates. 1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period. In the control period, 13 catheter-associated UTI and 29 catheter-associated asymptomatic bacteriuria events in 2889 catheter-days (0·45 catheter-associated UTI cases and 1·00 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) were recorded compared with four catheter-associated UTI and 16 catheter-associated asymptomatic bacteriuria events in 2338 catheter-days (0·17 catheter-associated UTI cases and 0·68 catheter-associated asymptomatic bacteriuria cases per 100 catheter-days) during the intervention period. The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080). There were no reported adverse events. INTERPRETATION The use of chlorhexidine solution for meatal cleaning before catheter insertion decreased the incidence of catheter-associated asymptomatic bacteriuria and UTI and has the potential to improve patient safety. FUNDING HCF Research Foundation.",2019,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","['Participants were excluded if they were younger than 2 years, had a medical reason preventing the use of the chlorhexidine, had the catheter inserted in theatre, did not have the catheter insertion date documented, required in-and-out or suprapubic catheterisation, had symptoms and signs suggestive of UTI at the time of catheter insertion, or were currently undergoing treatment for UTI', 'Australian hospitals', '1642 participants in these hospitals were included in the study between Aug 1, 2017, and March 12, 2018, 697 (42%) in the control phase and 945 (58%) in the intervention period', '21 hospitals were assessed for eligibility between Jan 5, 2017, and May 1, 2017; of these, three were successfully enrolled', 'Patients requiring a urinary cathetwer were potentially eligible for inclusion in this hospital-wide study', 'Eligible hospitals were Australian public and private hospitals, with an intensive care unit and more than 30\u2008000 hospital admissions per year']","['Chlorhexidine', 'normal saline', 'chlorhexidine solution', 'antiseptic meatal cleaning', 'chlorhexidine solution for meatal cleaning before urinary catheterisation with 0·9% normal saline']","['incidence of catheter-associated asymptomatic bacteriuria', 'adverse events', 'catheter-associated urinary tract infections', 'number of cases of catheter-associated asymptomatic bacteriuria and UTI per 100 catheter-days', 'incidence of catheter-associated UTI', 'asymptomatic bacteriuria events']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439508', 'cui_str': 'per year'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",21.0,0.152964,"The intervention was associated with a 74% reduction in the incidence of catheter-associated asymptomatic bacteriuria (incident rate ratio 0·26, 95% CI 0·08-0·86, p=0·026), and a 94% decrease in the incidence of catheter-associated UTI (0·06, 95% CI 0·01-0·32, p=0·00080).","[{'ForeName': 'Oyebola', 'Initials': 'O', 'LastName': 'Fasugba', 'Affiliation': ""Nursing Research Institute, Australian Catholic University & St Vincent's Health Australia, Sydney, NSW, Australia; Lifestyle Research Centre, Avondale College of Higher Education, Cooranbong, NSW, Australia.""}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Infectious Prevention and Healthcare Epidemiology Unit, Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gregory', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine Australian Catholic University, Watson, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collignon', 'Affiliation': 'Australian Capital Territory Pathology, Canberra Hospital and Health Services, Yamba Drive, Garran, ACT, Australia; Medical School, Australian National University, Acton, ACT, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Arts, Nursing and Theology, Avondale College of Higher Education, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30736-9'] 1125,30987844,Re: Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients with High-risk Prostate Cancer with Rising Prostate-specific Antigen Levels After Primary Local Therapy A Randomized Clinical Trial.,,2019,,['Patients with High-risk Prostate Cancer with Rising Prostate-specific Antigen Levels'],['Docetaxel to Androgen-Deprivation Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]",[],,0.0676478,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kretschmer', 'Affiliation': 'Department of Urology, University Hospital Munich, Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Tilki', 'Affiliation': 'Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: dtilki@me.com.'}]",European urology,['10.1016/j.eururo.2019.03.031'] 1126,30985861,Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations.,"Importance The United States spends more than $12 billion annually on graduate medical education. Understanding how residents balance patient care and educational activities may provide insights into how the modern physician workforce is being trained. Objective To describe how first-year internal medicine residents (interns) allocate time while working on general medicine inpatient services. Design, Setting, and Participants Direct observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region, of the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, a cluster-randomized trial comparing different duty-hour policies. A total of 194 weekday shifts were observed and time motion data were collected, sampled by daytime, nighttime, and call shifts in proportion to the distribution of shifts within each program from March 10 through May 31, 2016. Data were analyzed from June 1, 2016, through January 5, 2019. Main Outcomes and Measures Mean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night). Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care were tracked. Results A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours. A mean (SD) of 15.9 (0.7) hours of a 24-hour period (66%) was spent in indirect patient care, mostly interactions with the patient's medical record or documentation (mean [SD], 10.3 [0.7] hours; 43%). A mean (SD) of 3.0 (0.1) hours was spent in direct patient care (13%) and 1.8 (0.3) hours in education (7%). This pattern was consistent across the 4 periods of the day. Direct patient care and education frequently occurred when interns were performing indirect patient care. Multitasking with 2 or more indirect patient care activities occurred for a mean (SD) of 3.8 (0.4) hours (16%) of the day. Conclusions and Relevance This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities. These findings provide an essential baseline measure for future efforts designed to improve the workday structure and experience of internal medicine trainees, without making a judgment on the current allocation of time. Trial Registration ClinicalTrials.gov identifier: NCT02274818.",2019,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","['Participants\n\n\nDirect observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region', 'A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours']",[],"['indirect patient care activities', 'time motion data', 'Measures\n\n\nMean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night', 'Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]",[],"[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",,0.0475539,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","[{'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Manqing', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bellini', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'C Jessica', 'Initials': 'CJ', 'LastName': 'Dine', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Gitelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Yeager', 'Affiliation': 'Department of Medicine, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Asch', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0095'] 1127,30975525,"Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial.","BACKGROUND Few data are available to support the choice between the two currently available pneumococcal conjugate vaccines (PCVs), ten-valent PCV (PCV10) and 13-valent PCV (PCV13). Here we report a head-to-head comparison of the immunogenicity and reactogenicity of PCV10 and PCV13. METHODS In this parallel, open-label, randomised controlled trial, healthy infants from two districts in Ho Chi Minh City, Vietnam, were randomly allocated (in a 3:3:5:4:5:4 ratio), with use of a computer-generated list, to one of six infant PCV schedules: PCV10 in a 3 + 1 (group A), 3 + 0 (group B), 2 + 1 (group C), or two-dose schedule (group D); PCV13 in a 2 + 1 schedule (group E); or no infant PCV (control; group F). Blood samples were collected from infants between 2 months and 18 months of age at various timepoints before and after PCV doses and analysed (in a blinded manner) by ELISA and opsonophagocytic assay. The trial had two independent aims: to compare vaccination responses between PCV10 and PCV13, and to evaluate different schedules of PCV10. In this Article, we present results pertaining to the first aim. The primary outcome was the proportion of infants with an IgG concentration of at least 0·35 μg/mL for the ten serotypes common to the two vaccines at age 5 months, 4 weeks after the two-dose primary vaccination series (group C vs group E, per protocol population). An overall difference among the schedules was defined as at least seven of ten serotypes differing in the same direction at the 10% level. We also assessed whether the two-dose primary series of PCV13 (group E) was non-inferior at the 10% level to a three-dose primary series of PCV10 (groups A and B). This trial is registered with ClinicalTrials.gov, number NCT01953510. FINDINGS Of 1424 infants screened between Sept 30, 2013, and Jan 9, 2015, 1201 were allocated to the six groups: 152 (13%) to group A, 149 (12%) to group B, 250 (21%) to group C, 202 (17%) to group D, 251 (21%) to group E, and 197 (16%) to group F. 237 (95%) participants in group C (PCV10) and 232 (92%) in group E (PCV13) completed the primary vaccination series and had blood draws within the specified window at age 5 months, at which time the proportion of infants with IgG concentrations of at least 0·35 μg/mL did not differ between groups at the 10% level for any serotype (PCV10-PCV13 risk difference -2·1% [95% CI -4·8 to -0·1] for serotype 1; -1·3% [-3·7 to 0·6] for serotype 4; -3·4% [-6·8 to -0·4] for serotype 5; 15·6 [7·2 to 23·7] for serotype 6B; -1·3% [-3·7 to 0·6] for serotype 7F; -1·6% [-5·1 to 1·7] for serotype 9V; 0·0% [-2·7 to 2·9] for serotype 14; -2·1% [-5·3 to 0·9] for serotype 18C; 0·0% [-2·2 to 2·3] for serotype 19F; and -11·6% [-18·2 to -4·9] for serotype 23F). At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B). Reactogenicity and serious adverse events were monitored according to good clinical practice guidelines, and the profiles were similar in the two groups. INTERPRETATION PCV10 and PCV13 are similarly highly immunogenic when used in 2 + 1 schedule. The choice of vaccine might be influenced by factors such as the comparative magnitude of the antibody responses, price, and the relative importance of different serotypes in different settings. FUNDING National Health and Medical Research Council of Australia, and Bill & Melinda Gates Foundation.",2019,"At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B).","['infants in Ho Chi Minh City, Vietnam', 'healthy infants from two districts in Ho Chi Minh City, Vietnam', 'Of 1424 infants screened between Sept 30, 2013, and Jan 9, 2015, 1201']","['valent versus 13-valent pneumococcal conjugate vaccines', 'PCV13', 'PCV10', 'PCV10 and PCV13']","['Immunogenicity and reactogenicity', 'Blood samples', 'proportion of infants with an IgG concentration', 'Reactogenicity and serious adverse events']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1720589', 'cui_str': 'Greek letter chi'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0963062,"At the same timepoint, two doses of PCV13 were non-inferior to three doses of PCV10 for nine of the ten shared serotypes (excluding 6B).","[{'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Temple', 'Affiliation': ""Division of Global and Tropical Health, Menzies School of Health Research, Darwin, NT, Australia; Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia. Electronic address: beth.temple@menzies.edu.au.""}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thi Trang', 'Initials': 'VTT', 'LastName': 'Dai', 'Affiliation': 'Department of Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bright', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Paul Vincent', 'Initials': 'PV', 'LastName': 'Licciardi', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Rachel Ann', 'Initials': 'RA', 'LastName': 'Marimla', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Cattram Duong', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Doan Y', 'Initials': 'DY', 'LastName': 'Uyen', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Balloch', 'Affiliation': ""Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Tran Ngoc', 'Initials': 'TN', 'LastName': 'Huu', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Edward Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK; Department of Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30734-5'] 1128,30975047,The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial.,"AIM The aim of this study was to assess the impact on health-related quality of life (HRQoL) of a telehealth care solution compared with usual practice of patients with heart failure (HF). METHODS A randomized controlled trial with a telehealth care solution (Telekit) as the intervention (with a focus on self-empowerment achieved by engaging patients in their own illness through self-monitoring) combined with usual care and usual care as the control. The primary outcome was a change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score. Secondary outcomes were changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) score, all of which were assessed from baseline to approximately 12 months' follow-up between the two groups. Outcomes were assessed via unadjusted and adjusted analyses. RESULTS At baseline, 299 (145 interventions, 154 controls) patients were enrolled. In the primary analysis ( n  = 299), the adjusted intervention effects were PCS -0.81 (95% CI -2.7-1.1), MCS 4.66 (95% CI 1.8-7.5) and KCCQ12 3.67 (95% CI -0.7-8.1). Only the change in MCS was statistically significant. An unadjusted analysis replicated the primary analysis. Complete case analyses ( n  = 193) generally resulted in a lower intervention effect on the PCS score, but the difference remained statistically insignificant. CONCLUSIONS Only the MCS score was significantly higher in the telehealth care group compared to the control group. ClinicalTrials.gov (NCT02860013), July 28, 2016.",2019,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","['patients with heart failure (HF', '299 (145 interventions, 154 controls) patients were enrolled', 'patients with heart failure']","['telehealth care', 'telehealth care solution (Telekit']","['MCS score', 'health-related quality of life (HRQoL', 'change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score', 'MCS', 'Cardiomyopathy Questionnaire 12 (KCCQ12) score', 'PCS score', 'changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",,0.167949,"In the primary analysis ( n = 299), the adjusted intervention effects were PCS -0.81","[{'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Cichosz', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Udsen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hejlesen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19832713'] 1129,30963410,The Effects of Selenium Supplementation on Clinical Symptoms and Gene Expression Related to Inflammation and Vascular Endothelial Growth Factor in Infertile Women Candidate for In Vitro Fertilization.,"This study was performed to determine the effects of selenium supplementation on clinical symptoms and gene expression related to inflammatory markers in infertile women with polycystic ovary syndrome (PCOS) who were candidate for in vitro fertilization (IVF). Thirty-six women candidate for IVF were recruited in this randomized double-blinded, placebo-controlled trial. They (n = 18/group) were randomly assigned into intervention groups to take either 200 μg/day of selenium or placebo for 8 weeks. RT-PCR findings indicated that selenium supplementation downregulated gene expression of interleukin-1 (IL-1) (P < 0.004) and tumor necrosis factor alpha (TNF-α) (P = 0.02) in lymphocytes of patients with PCOS compared with the placebo. In addition, selenium supplementation upregulated gene expression of vascular endothelial growth factor (VEGF) (P = 0.001) in lymphocytes of patients with PCOS compared with the placebo. Selenium supplementation had no significant effect on clinical symptoms and gene expression of IL-8 (P = 0.10) and transforming growth factor beta (TGF-β) (P = 0.63). Overall, our findings documented that selenium supplementation for 8 weeks to infertile women candidate for IVF improved IL-1, TNF-α, and VEGF gene expression, though selenium had no effect on clinical symptoms and, IL-8 and TGF-β gene expression. Clinical trial registration number: http://www.irct.ir: IRCT20170513033941N23.",2020,Selenium supplementation had no significant effect on clinical symptoms and gene expression of IL-8,"['They (n\u2009=\u200918/group', 'Infertile Women Candidate for In Vitro Fertilization', 'infertile women with polycystic ovary syndrome (PCOS) who were candidate for in vitro fertilization (IVF', 'Thirty-six women candidate for IVF']","['Selenium supplementation', 'placebo', 'selenium supplementation', 'selenium or placebo', 'Selenium Supplementation']","['tumor necrosis factor alpha (TNF-α', 'clinical symptoms and, IL-8 and TGF-β gene expression', 'Clinical Symptoms and Gene Expression', 'clinical symptoms and gene expression of IL-8', 'gene expression of vascular endothelial growth factor (VEGF', 'gene expression of interleukin-1 (IL-1', 'transforming growth factor beta (TGF-β', 'IVF improved IL-1, TNF-α, and VEGF gene expression']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",36.0,0.700231,Selenium supplementation had no significant effect on clinical symptoms and gene expression of IL-8,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidar', 'Affiliation': 'Infertility and Reproductive Health Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Hamzepour', 'Affiliation': 'Infertility and Reproductive Health Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Zadeh Modarres', 'Affiliation': 'Laser Application in Medical Science Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mirzamoradi', 'Affiliation': 'Infertility and Reproductive Health Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Pourhanifeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, IR, Iran. asemi_r@yahoo.com.'}]",Biological trace element research,['10.1007/s12011-019-01715-5'] 1130,30968559,Clinical outcomes at 2 years of the Absorb bioresorbable vascular scaffold versus the Xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease-AIDA trial substudy.,"BACKGROUND Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. METHODS AND RESULTS We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). CONCLUSION In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.",2020,"There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). ","['patients presenting with acute coronary syndrome versus stable coronary disease-AIDA trial substudy', 'treated patients presenting either with or without ACS', 'Patients with acute coronary syndrome (ACS']","['Absorb bioresorbable vascular scaffold versus the Xience drug-eluting metallic stent', 'Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES']","['definite or probable device thrombosis', 'Definite or probable device thrombosis', 'rate of the 2-year primary endpoint of target vessel failure (TVF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.04951,"There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). ","[{'ForeName': 'Ruben Y G', 'Initials': 'RYG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Kraak', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'E Karin', 'Initials': 'EK', 'LastName': 'Arkenbout', 'Affiliation': 'The Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Auke P J D', 'Initials': 'APJD', 'LastName': 'Weevers', 'Affiliation': 'The Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Laura S M', 'Initials': 'LSM', 'LastName': 'Kerkmeijer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marcel A M', 'Initials': 'MAM', 'LastName': 'Beijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M Marije', 'Initials': 'MM', 'LastName': 'Vis', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28193'] 1131,31808514,Development and validation of a nomogram to predict the prognosis of patients with squamous cell carcinoma of the bladder.,"BACKGROUND The present study aimed to develop and validate a nomogram based on expanded TNM staging to predict the prognosis for patients with squamous cell carcinoma of the bladder (SCCB). METHODS A total of 595 eligible patients with SCCB identified in the Surveillance, Epidemiology, and End Results (SEER) dataset were randomly divided into training set (n = 416) and validation set (n = 179). The likelihood ratio test was used to select potentially relevant factors for developing the nomogram. The performance of the nomogram was validated on the training and validation sets using a C-index with 95% confidence interval (95% CI) and calibration curve, and was further compared with TNM staging system. RESULTS The nomogram included six factors: age, T stage, N stage, M stage, the method of surgery and tumor size. The C-indexes of the nomogram were 0.768 (0.741-0.795) and 0.717 (0.671-0.763) in the training and validation sets, respectively, which were higher than the TNM staging system with C-indexes of 0.580 (0.543-0.617) and 0.540 (0.484-0.596) in the training and validation sets, respectively. Furthermore, the decision curve analysis (DCA) proved that the nomogram provided superior clinical effectiveness. CONCLUSIONS We developed a nomogram that help predict individualized prognosis for patients with SCCB.",2019,"The C-indexes of the nomogram were 0.768 (0.741-0.795) and 0.717 (0.671-0.763) in the training and validation sets, respectively, which were higher than the TNM staging system with C-indexes of 0.580 (0.543-0.617) and 0.540 (0.484-0.596) in the training and validation sets, respectively.","['patients with SCCB', 'patients with squamous cell carcinoma of the bladder (SCCB', '595 eligible patients with SCCB identified in the Surveillance, Epidemiology, and End Results', 'patients with squamous cell carcinoma of the bladder']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],[],595.0,0.0483401,"The C-indexes of the nomogram were 0.768 (0.741-0.795) and 0.717 (0.671-0.763) in the training and validation sets, respectively, which were higher than the TNM staging system with C-indexes of 0.580 (0.543-0.617) and 0.540 (0.484-0.596) in the training and validation sets, respectively.","[{'ForeName': 'Mei-Di', 'Initials': 'MD', 'LastName': 'Hu', 'Affiliation': 'Department of General Practice, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Si-Hai', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Nephrology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai 200240, China.""}, {'ForeName': 'Ling-Hua', 'Initials': 'LH', 'LastName': 'Jia', 'Affiliation': ""Department of Urology, Jiangxi Provincial People's Hospital Affiliated to Nanchang University, Nanchang 330006, China.""}]",Bioscience reports,['10.1042/BSR20193459'] 1132,30889279,A Prospective Study of Alcohol Use Patterns and Short-Term Weight Change in College Freshmen.,"BACKGROUND The transition to college is a developmentally sensitive time in which freshmen are at high risk for engaging in heavy drinking and experiencing changes in weight and body composition. The study tested prospective associations among drinking patterns (weekly drinks, heavy drinking occasions/month) and alcohol calorie intake on weight and waist circumference change over the first year of college. METHODS College freshmen (N = 103) were randomly selected from a pool of eligible students to participate at the beginning of the academic year. The sample was comprised of 52% males, 46% of individuals identifying as racial or ethnic minority, and 45% students with at-risk drinking as defined by the Alcohol Use Disorders Identification Test-Consumption questions. Students engaging in daily risky drinking (n = 2) were excluded. Participants attended 3 visits during the academic year during which they provided weight and waist circumference measurements and completed assessments about drinking, dietary intake, and physical activity. RESULTS Weight gain (>2.3 kg) occurred in 28% of participants. In linear mixed models, drinking patterns and alcohol calorie intake were not associated with weight or waist circumference changes within individuals, when controlling for demographic and energy balance variables. Drinking patterns and alcohol calorie intake did not account for differences in anthropometric measurements between participants, when controlling for covariates. CONCLUSIONS Alcohol use did not explain the anthropometric changes observed in a sample well represented by freshmen engaging in risky drinking (and excluding those with daily risky drinking) during the academic year. Drinking may not contribute to short-term weight gain among freshmen.",2019,"In linear mixed models, drinking patterns and alcohol calorie intake were not associated with weight or waist circumference changes within individuals, when controlling for demographic and energy balance variables.","['N\xa0=\xa0103) were randomly selected from a pool of eligible students to participate at the beginning of the academic year', 'The sample was comprised of 52% males, 46% of individuals identifying as racial or ethnic minority, and 45% students with at-risk drinking as defined by the Alcohol Use Disorders Identification Test-Consumption questions', 'College freshmen', 'College Freshmen', 'Students engaging in daily risky drinking (n\xa0=\xa02) were excluded']","['drinking patterns (weekly drinks, heavy drinking occasions/month) and alcohol calorie intake']","['weight or waist circumference changes', 'Drinking patterns and alcohol calorie intake', 'weight and waist circumference change', 'Weight gain']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1286344', 'cui_str': 'Drinking pattern (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",103.0,0.0145412,"In linear mixed models, drinking patterns and alcohol calorie intake were not associated with weight or waist circumference changes within individuals, when controlling for demographic and energy balance variables.","[{'ForeName': 'Tera L', 'Initials': 'TL', 'LastName': 'Fazzino', 'Affiliation': 'Department of Preventive Medicine and Public Health , University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kelsie', 'Initials': 'K', 'LastName': 'Forbush', 'Affiliation': 'Department of Psychology , University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Sullivan', 'Affiliation': 'Department of Nutrition and Dietetics , University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'Department of Preventive Medicine and Public Health , University of Kansas Medical Center, Kansas City, Kansas.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14025'] 1133,31712950,Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial.,"BACKGROUND AND OBJECTIVES To investigate the feasibility of delivering a functional exercise-based prehabilitation intervention and its effects on postoperative length of hospital stay, preoperative physical functioning and health-related quality of life in elective colorectal surgery. MATERIALS AND METHODS In this randomised controlled feasibility trial, 22 elective colorectal surgery patients were randomly assigned to exercise prehabilitation (n = 11) or standard care (n = 11). Feasibility of delivering the intervention was assessed based on recruitment and compliance to the intervention. Impact on postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life were also assessed. RESULTS Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery. Of those who were eligible, approximately 18% consented to the trial. Median length of hospital stay was 8 [range 6-27] and 10 [range 5-12] days respectively for the standard care and prehabilitation groups. Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care. CONCLUSIONS Despite prehabilitation appearing to convey positive benefits on physical functioning, short surgical wait times and patient engagement represent major obstacles to implementing exercise prehabilitation programmes in colorectal cancer patients.",2020,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care. ","['colorectal cancer patients', 'patients scheduled for elective colorectal surgery', 'Over 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery', '22 elective colorectal surgery patients']","['novel exercise prehabilitation programme', 'standard care', 'exercise prehabilitation', 'functional exercise-based prehabilitation intervention']","['Median length of hospital stay', 'stair climb test and 6-min walk test', 'postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life', 'postoperative length of hospital stay, preoperative physical functioning and health-related quality of life']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",22.0,0.0883603,"Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care. ","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Northgraves', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Arunachalam', 'Affiliation': 'General Surgery, Pinderfields Hospital, Wakefield, UK.'}, {'ForeName': 'Leigh A', 'Initials': 'LA', 'LastName': 'Madden', 'Affiliation': 'Department of Biomedical Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Marshall', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hartley', 'Affiliation': 'Academic Surgical Unit, Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'MacFie', 'Affiliation': 'Combined Gastroenterology Research Unit, Scarborough Hospital, Scarborough, UK.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Vince', 'Affiliation': 'Sport, Health and Exercise Science, School of Life Sciences, University of Hull, Hull, UK. Rebecca.vince@hull.ac.uk.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05098-0'] 1134,30957170,"An Open-Label, Randomized, Active-Controlled Trial of 8 Versus 12 Weeks of Elbasvir/Grazoprevir for Treatment-Naive Patients With Chronic Hepatitis C Genotype 1b Infection and Mild Fibrosis (EGALITE Study): Impact of Baseline Viral Loads and NS5A Resistance-Associated Substitutions.","BACKGROUND A 12-week grazoprevir/elbasvir regimen is highly effective against hepatitis C virus genotype 1 (HCV-1) infection. The efficacy of an 8-week regimen for treatment-naive HCV-1-infected patients with mild fibrosis has not been determined. METHODS Treatment-naive HCV-1b-infected patients with mild fibrosis were randomly assigned to receive 8 (n = 41) or 12 (n = 41) weeks of grazoprevir/elbasvir therapy. The primary end point was a sustained virologic response, defined as an HCV RNA level of < 12 IU/mL, at posttreatment week 12 (SVR12). RESULTS SVR12 was achieved by 87.8% of patients (36 of 41) in the 8-week arm and 100% (41 of 41) in the 8-week arm of the full-analysis population and by 90.0% (36 of 40) and 100% (41 of 41), respectively, in the per-protocol population (all P = .055). In the 8-week arm, a significantly lower SVR12 rate was observed among patients with a high HCV-1b load, defined as ≥1 500 000 IU/mL (79% vs 100%; P = .042), and among those with a baseline Y93H resistance-associated substitution (RAS) frequency of >15% in HCV nonstructural protein 5A (NS5A; 40.0% vs 97.1%; P = .004). Between-group analysis demonstrated that, among patient with a high HCV-1b load and a baseline Y93H RAS frequency of >15%, those in the 8-week arm had a substantially lower SVR12 rate than those in the 12-week arm (40.0% vs 100.0%). All 4 HCV-1b relapses had a Y93H RAS frequency of >99% at posttreatment week 12. CONCLUSIONS Twelve weeks of grazoprevir/elbasvir therapy is highly effective for treatment-naive patients with mild fibrosis. A truncated, 8-week grazoprevir/elbasvir regimen might be applied for those with low viral loads or without a significant NS5A RAS frequency. CLINICAL TRIALS REGISTRATION NCT03186365.",2019,"All four HCV-1b relapses had NS5A RAS Y93H> 99% at post-treatment week-12. ","['HCV-1b naïve patients with mild fibrosis', 'naïve patients with mild fibrosis', 'treatment-naïve chronic hepatitis C genotype 1b patients with mild fibrosis (EGALITE', 'HCV-1b naïve patients with mild fibrosis were randomized to 8 (n=41) or 12 (n=41) weeks of']","['NS5A resistance-associated substitution', 'grazoprevir/elbasvir', 'elbasvir/grazoprevir']","['SVR12 rate', 'SVR12', 'SVR12 (HCV RNA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4049394', 'cui_str': 'Chronic hepatitis C genotype 1b'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4080053', 'cui_str': 'grazoprevir'}, {'cui': 'C4080052', 'cui_str': 'elbasvir'}, {'cui': 'C4080453', 'cui_str': 'elbasvir / grazoprevir'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.0634156,"All four HCV-1b relapses had NS5A RAS Y93H> 99% at post-treatment week-12. ","[{'ForeName': 'Chung-Feng', 'Initials': 'CF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Chao-Hung', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital, ChiaYi.'}, {'ForeName': 'Pin-Nan', 'Initials': 'PN', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung City.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei.'}, {'ForeName': 'Jia-Horng', 'Initials': 'JH', 'LastName': 'Kao', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei.'}, {'ForeName': 'Shih-Jer', 'Initials': 'SJ', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital-Yunlin Branch, Yunlin.'}, {'ForeName': 'Pei-Lun', 'Initials': 'PL', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan.'}, {'ForeName': 'Jyh-Jou', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Tainan.'}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Chien', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taipei.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Peng', 'Affiliation': 'Division of Hepatology and Gastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung.'}, {'ForeName': 'Chun-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Division of Hepatology, Department of Gastroenterology and Hepatology, Linkou Medical Center, Chang Gung Memorial Hospital, Taipei.'}, {'ForeName': 'Tsai-Yuan', 'Initials': 'TY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Gastroenterology, Tri-service General Hospital, Taipei.'}, {'ForeName': 'Chun-Han', 'Initials': 'CH', 'LastName': 'Cheng', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung City.'}, {'ForeName': 'Chia-Yen', 'Initials': 'CY', 'LastName': 'Dai', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Jee-Fu', 'Initials': 'JF', 'LastName': 'Huang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Wan-Long', 'Initials': 'WL', 'LastName': 'Chuang', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Hepatobiliary Division, Department of Internal Medicine, ChiaYi.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz154'] 1135,31635689,A behaviour change package to prevent hand dermatitis in nurses working in health care: the SCIN cluster RCT.,"BACKGROUND Although strategies have been developed to minimise the risk of occupational hand dermatitis in nurses, their clinical effectiveness and cost-effectiveness remain unclear. OBJECTIVES The Skin Care Intervention in Nurses trial tested the hypothesis that a behaviour change package intervention, coupled with provision of hand moisturisers, could reduce the point prevalence of hand dermatitis when compared with standard care among nurses working in the NHS. The secondary aim was to assess the impact of the intervention on participants' beliefs and behaviour regarding hand care, and the cost-effectiveness of the intervention in comparison with normal care. DESIGN Cluster randomised controlled trial. SETTING Thirty-five NHS hospital trusts/health boards/universities. PARTICIPANTS First-year student nurses with a history of atopic tendency, and full-time intensive care unit nurses. INTERVENTION Sites were randomly allocated to be 'intervention plus' or 'intervention light'. Participants at 'intervention plus' sites received access to a bespoke online behaviour change package intervention, coupled with personal supplies of moisturising cream (student nurses) and optimal availability of moisturising cream (intensive care unit nurses). Nurses at 'intervention light' sites received usual care, including a dermatitis prevention leaflet. MAIN OUTCOME MEASURE The difference between intervention plus and intervention light sites in the change of point prevalence of visible hand dermatitis was measured from images taken at baseline and at follow-up. RANDOMISATION Fourteen sites were randomised to the intervention plus arm, and 21 sites were randomised to the intervention light arm. BLINDING The participants, trial statistician, methodologist and the dermatologists interpreting the hand photographs were blinded to intervention assignment. NUMBERS ANALYSED An intention-to-treat analysis was conducted on data from 845 student nurses and 1111 intensive care unit nurses. RESULTS The intention-to-treat analysis showed no evidence that the risk of developing dermatitis was greater in the intervention light group than in the intervention plus group (student nurses: odds ratio 1.25, 95% confidence interval 0.59 to 2.69; intensive care unit nurses: odds ratio 1.41, 95% confidence interval 0.81 to 2.44). Both groups had high levels of baseline beliefs about the benefits of using hand moisturisers before, during and after work. The frequency of use of hand moisturisers before, during and after shifts was significantly higher in the intensive care unit nurses in the intervention plus arm at follow-up than in the comparator group nurses. For student nurses, the intervention plus group mean costs were £2 lower than those for the comparator and 0.00002 more quality-adjusted life-years were gained. For intensive care unit nurses, costs were £4 higher and 0.0016 fewer quality-adjusted life-years were gained. HARMS No adverse events were reported. LIMITATIONS Only 44.5% of participants in the intervention plus arm accessed the behaviour change package. CONCLUSION The intervention did not result in a statistically significant decrease in the prevalence of hand dermatitis in the intervention plus group. FUTURE WORK Participants had a high level of baseline beliefs about the importance of using hand moisturisers before, during and after work. Future research should focus on how workplace culture can be changed in order for that knowledge to be actioned. TRIAL REGISTRATION Current Controlled Trials ISRCTN53303171. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 58. See the NIHR Journals Library website for further project information.",2019,"For intensive care unit nurses, costs were £4 higher and 0.0016 fewer quality-adjusted life-years were gained. ","['845 student nurses and 1111 intensive care unit nurses', 'nurses working in health care', 'Thirty-five', 'First-year student nurses with a history of atopic tendency, and full-time intensive care unit nurses']","['access to a bespoke online behaviour change package intervention, coupled with personal supplies of moisturising cream (student nurses) and optimal availability of moisturising cream (intensive care unit nurses', 'usual care, including a dermatitis prevention leaflet', ""intervention plus' or 'intervention light""]","['behaviour change package', 'risk of developing dermatitis', 'adverse events', 'prevalence of hand dermatitis']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0239816', 'cui_str': 'Hand eczema (disorder)'}]",1111.0,0.0973099,"For intensive care unit nurses, costs were £4 higher and 0.0016 fewer quality-adjusted life-years were gained. ","[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Madan', 'Affiliation': ""Occupational Health Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Vaughan', 'Initials': 'V', 'LastName': 'Parsons', 'Affiliation': ""Occupational Health Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Ntani', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'English', 'Affiliation': 'Dermatology, Circle Nottingham NHS Treatment Centre, Nottingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coggon', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Centre for the Economics of Mental and Physical Health, King's College London, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smedley', 'Affiliation': 'Occupational Health Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Rushton', 'Affiliation': 'Epidemiology and Biostatistics, Imperial College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trial Unit, King's College London, London, UK.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Cookson', 'Affiliation': 'Medical Microbiology, University College London, London, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Lavender', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hywel', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23580'] 1136,31711154,Feasibility and acceptability of an intervention for enhancing reintegration in adults with experience of homelessness.,"BACKGROUND Service centres for homeless adults are potential settings for implementation of reintegration interventions. This study aimed to evaluate (i) the acceptability of a group-based programme among individuals from the broad population of homeless people and (ii) if a future study of its feasibility and acceptability for re-housed homeless people is warranted. METHODS Recruiting participants and intervention facilitators from partnering service centres was thought to improve recruitment and retention, cost-effectiveness and social interactions compared to professional-led interventions. Seven adults with experience of homelessness (three females, four males, mean age 39 years, range 18-63) were recruited to participate in the intervention. The research protocol comprised completion pre/post of scales [Recovering Quality of Life questionnaire; Working Alliance Inventory-short form revised (WAI-SR)] and focus groups, and WAI-SR and focus groups after sessions 3 and 6. RESULTS The intervention and research protocols were feasible, with all participants engaging in all sessions, completing all scales and attending all focus groups. The quantitative data demonstrated the feasibility of obtaining practically useful measures of relevant outcomes. In the four focus groups, the intervention received very favourable feedback. CONCLUSIONS This study demonstrated initial feasibility and acceptability of an intervention that places minimal burden on infrastructure and promotes user autonomy. This is an important advance as there is increasing recognition that the challenge of reintegration is as much a psychological and social problem as a housing problem. If effective, this style of intervention may serve as a template for future interventions with similar populations.",2020,"In the four focus groups, the intervention received very favourable feedback. ","['individuals from the broad population of homeless people and (ii', 'Seven adults with experience of homelessness (three females, four males, mean age 39\u2009years, range 18-63', 'Recruiting participants and intervention facilitators from partnering service centres', 'homeless adults', 'adults with experience of homelessness']",['Alliance Inventory-short form revised (WAI-SR'],"['recruitment and retention, cost-effectiveness and social interactions', 'Feasibility and acceptability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",7.0,0.0405919,"In the four focus groups, the intervention received very favourable feedback. ","[{'ForeName': 'Eva C', 'Initials': 'EC', 'LastName': 'Sundin', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mrowiec', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Bowpitt', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Boatman', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sarkar', 'Affiliation': 'Department of Sport and Exercise Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Thom S', 'Initials': 'TS', 'LastName': 'Baguley', 'Affiliation': 'Department of Psychology, Nottingham Trent University, Nottingham, UK.'}]",European journal of public health,['10.1093/eurpub/ckz202'] 1137,31597662,Randomized Phase 0/I Trial of the Mitochondrial Inhibitor ME-344 or Placebo Added to Bevacizumab in Early HER2-Negative Breast Cancer.,"PURPOSE We previously demonstrated that mitochondrial inhibitors' efficacy was restricted to a metabolic context in which mitochondrial respiration was the predominant energy source, a situation achievable by inducing vascular normalization/hypoxia correction with antiangiogenics. Vascular normalization can be tracked with 2[18F]fluoro-2-deoxy-d-glucose (FDG)-PET. We tested the efficacy of the mitochondrial inhibitor ME-344 or placebo added to bevacizumab in early breast cancer. PATIENTS AND METHODS Treatment-naïve HER2-negative patients with T > 1 cm (any N) underwent a breast-centered 18 F-fluorodeoxyglucose (FDG)-PET (day 1) and received a single dose of bevacizumab (15 mg/kg), followed by a second FDG-PET (day 8). Patients were then randomized (1:1) to Arm A (ME-344 10 mg/kg intravenous on days 8, 15, and 21) or Arm B (placebo). Tumors were biopsied on days 0 and 29. Succinate dehydrogenase enzyme histochemistry (SDH-EHC), confocal microscopy of vessel architecture, and HIF1α staining were performed in pre- and posttreatment biopsies to assess the pharmacodynamics, vessel normalization, and tissue re-oxygenation by bevacizumab, respectively. RESULTS ME-344 displayed significant biological activity versus placebo: compared with a 186% increase in Arm B, Ki67 decreased by 23.4% from days 0 to 28 in Arm A ( P < 0.001) ( N = 42 patients). FDG-PET predicted vascular normalization in about one-third of the patients in each arm, which was confirmed using confocal microscopy and HIF1α staining. In the subgroup with vascular normalization, ME-344 induced a Ki67 decrease of 33.4% (placebo: 11.8 increase). SDH-EHC suggested on-target effects of ME-344. CONCLUSIONS ME-344 has significant biological antitumor activity in HER2-negative breast cancer, particularly after induction of vascular normalization and tissue reoxygenation with bevacizumab.",2020,"ME-344 displayed significant biological activity versus placebo: compared with a 186% increase in Arm B, Ki67 decreased by 23.4% from days 0 to 28 in Arm A (P < 0.001).","['early breast cancer', 'Treatment-naïve HER2-negative patients with T>1cm (any N) underwent a', 'N=42 patients', 'early HER2-negative breast cancer']","['breast-centered FDG-PET', 'mitochondrial inhibitor ME-344 or placebo', 'Arm A (ME-344 10 mg/kg intravenous on days 8, 15, and 21) or Arm B (placebo', 'placebo', 'bevacizumab']","['vascular normalization', 'Vascular normalization', 'Succinate dehydrogenase enzyme histochemistry (SDH-EHC), confocal microscopy of vessel architecture, and HIF-1a staining', 'biological activity']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0038615', 'cui_str': 'Succinic Dehydrogenase'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0242842', 'cui_str': 'Microscopy, Confocal'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",42.0,0.237221,"ME-344 displayed significant biological activity versus placebo: compared with a 186% increase in Arm B, Ki67 decreased by 23.4% from days 0 to 28 in Arm A (P < 0.001).","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Quintela-Fandino', 'Affiliation': 'Breast Cancer Clinical Research Unit - Clinical Research Program, CNIO - Spanish National Cancer Research Center, Madrid, Spain. mquintela@cnio.es.'}, {'ForeName': 'Serafín', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Medical Oncology, Hospital Universitari Arnau Vilanova, Lleida, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Cortés-Salgado', 'Affiliation': 'Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Apala', 'Affiliation': 'Breast Cancer Clinical Research Unit - Clinical Research Program, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Breast Cancer Clinical Research Unit - Clinical Research Program, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Gasol Cudos', 'Affiliation': 'Medical Oncology, Hospital Universitari Arnau Vilanova, Lleida, Spain.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Salla Fortuny', 'Affiliation': 'Medical Oncology, Hospital Universitari Arnau Vilanova, Lleida, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gion', 'Affiliation': 'Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Alonso', 'Affiliation': 'Breast Cancer Clinical Research Unit - Clinical Research Program, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'ION Institute of Oncology, Quironsalud Group - Madrid and Barceona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Guerra', 'Affiliation': 'Medical Oncology, Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Malón', 'Affiliation': 'Medical Oncology, Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Caleiras', 'Affiliation': 'Histopathology Unit, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Mulero', 'Affiliation': 'Molecular Imaging Unit, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Mouron', 'Affiliation': 'Breast Cancer Clinical Research Unit - Clinical Research Program, CNIO - Spanish National Cancer Research Center, Madrid, Spain.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2023'] 1138,31713952,Working memory training and brain structure and function in extremely preterm or extremely low birth weight children.,"This study in children born extremely preterm (EP; <28 weeks' gestational age) or extremely low birth weight (ELBW; <1,000 g) investigated whether adaptive working memory training using Cogmed® is associated with structural and/or functional brain changes compared with a placebo program. Ninety-one EP/ELBW children were recruited at a mean (standard deviation) age of 7.8 (0.4) years. Children were randomly allocated to Cogmed or placebo (45-min sessions, 5 days a week over 5-7 weeks). A subset had usable magnetic resonance imaging (MRI) data pretraining and 2 weeks posttraining (structural, n = 48; diffusion, n = 43; task-based functional, n = 18). Statistical analyses examined whether cortical morphometry, white matter microstructure and blood oxygenation level-dependent (BOLD) signal during an n-back working memory task changed from pretraining to posttraining in the Cogmed and placebo groups separately. Interaction analyses between time point and group were then performed. There was a significant increase in neurite density in several white matter regions from pretraining to posttraining in both the Cogmed and placebo groups. BOLD signal in the posterior cingulate and precuneus cortices during the n-back task increased from pretraining to posttraining in the Cogmed but not placebo group. Evidence for group-by-time interactions for the MRI measures was weak, suggesting that brain changes generally did not differ between Cogmed and placebo groups. Overall, while some structural and functional MRI changes between the pretraining and posttraining period in EP/ELBW children were observed, there was little evidence of training-induced neuroplasticity, with changes generally identified in both groups. Trial registration Australian New Zealand Clinical Trials Registry, anzctr.org.au; ACTRN12612000124831.",2020,There was a significant increase in neurite density in several white matter regions from pretraining to posttraining in both the Cogmed and placebo groups.,"[""children born extremely preterm (EP; <28\u2009weeks' gestational age) or extremely low birth weight (ELBW; <1,000\u2009g"", 'extremely preterm or extremely low birth weight children', 'Ninety-one EP/ELBW children were recruited at a mean (standard deviation) age of 7.8 (0.4) years']","['placebo', 'adaptive working memory training using Cogmed®', 'Working memory training', 'placebo program']","['neurite density', 'cortical morphometry, white matter microstructure and blood oxygenation level-dependent (BOLD) signal', 'structural and functional MRI changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0085103', 'cui_str': 'Neurites'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0200760', 'cui_str': 'Morphometry'}, {'cui': 'C0682708'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",91.0,0.324395,There was a significant increase in neurite density in several white matter regions from pretraining to posttraining in both the Cogmed and placebo groups.,"[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Kelly', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Deanne K', 'Initials': 'DK', 'LastName': 'Thompson', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Developmental Imaging, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Elisha K', 'Initials': 'EK', 'LastName': 'Josev', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Pascoe', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Spencer-Smith', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Adamson', 'Affiliation': ""Developmental Imaging, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Nosarti', 'Affiliation': ""Centre for the Developing Brain, Department of Perinatal Imaging and Health, School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gathercole', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gehan', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Marc L', 'Initials': 'ML', 'LastName': 'Seal', 'Affiliation': ""Developmental Imaging, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Anderson', 'Affiliation': ""Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}]",Human brain mapping,['10.1002/hbm.24832'] 1139,29458842,"Cognitive response to fish oil, blueberry, and combined supplementation in older adults with subjective cognitive impairment.","Given evidence that eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and anthocyanin-rich blueberries provide neurocognitive benefit, we investigated long-term supplementation in older adults with cognitive complaints. In a 24-week randomized, double-blind, placebo-controlled trial, elderly men and women received daily fish oil (FO) or blueberry (BB) or both. Diet records confirmed that participants reduced background consumption of EPA, DHA, and anthocyanins as prescribed. Erythrocyte EPA + DHA composition increased in the FO groups (p = 0.0001). Total urinary anthocyanins did not differ between the groups after supplementation but glycoside and native (food) forms increased only in the BB-supplemented groups. The FO (p = 0.03) and BB (p = 0.05) groups reported fewer cognitive symptoms, and the BB group showed improved memory discrimination (p = 0.04), indicating that supplementation improved cognition. Cognitive benefit in the BB group was associated with the presence of urinary anthocyanins reflecting recent BB intake but not with anthocyanin metabolites. However, combined FO + BB treatment was not associated with cognitive enhancement as expected.",2018,"The FO (p = 0.03) and BB (p = 0.05) groups reported fewer cognitive symptoms, and the BB group showed improved memory discrimination (p = 0.04), indicating that supplementation improved cognition.","['elderly men and women received', 'older adults with subjective cognitive impairment', 'older adults with cognitive complaints']","['Cognitive response to fish oil, blueberry, and combined supplementation', 'placebo', 'daily fish oil (FO) or blueberry (BB', 'eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and anthocyanin-rich blueberries', 'combined FO\xa0+ BB']","['Cognitive benefit', 'Erythrocyte EPA\xa0+ DHA composition', 'cognitive symptoms', 'memory discrimination', 'cognition', 'background consumption of EPA, DHA, and anthocyanins', 'Total urinary anthocyanins']","[{'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.364462,"The FO (p = 0.03) and BB (p = 0.05) groups reported fewer cognitive symptoms, and the BB group showed improved memory discrimination (p = 0.04), indicating that supplementation improved cognition.","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.'}, {'ForeName': 'Wilhelmina', 'Initials': 'W', 'LastName': 'Kalt', 'Affiliation': 'Agriculture and Agri-Food Canada, Kentville Research and Development Centre, Kentville, Nova Scotia, Canada.'}, {'ForeName': 'Marcelle D', 'Initials': 'MD', 'LastName': 'Shidler', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McDonald', 'Affiliation': 'Agriculture and Agri-Food Canada, Kentville Research and Development Centre, Kentville, Nova Scotia, Canada.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Summer', 'Affiliation': ""Clinical Translational Research Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Stover', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krikorian', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati Academic Health Center, Cincinnati, OH, USA. Electronic address: robert.krikorian@uc.edu.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2017.12.003'] 1140,30401918,Management and diagnosis of mitochondrial fatty acid oxidation disorders: focus on very-long-chain acyl-CoA dehydrogenase deficiency.,"Mitochondrial fatty acid oxidation disorders (FAODs) are caused by defects in β-oxidation enzymes, including very long-chain acyl-CoA dehydrogenase (VLCAD), trifunctional protein (TFP), carnitine palmitoyltransferase-2 (CPT2), carnitine-acylcarnitine translocase (CACT) and others. During prolonged fasting, infection, or exercise, patients with FAODs present with hypoglycemia, rhabdomyolysis, cardiomyopathy, liver dysfunction, and occasionally sudden death. This article describes the diagnosis, newborn screening, and treatment of long-chain FAODs with a focus on VLCAD deficiency. VLCAD deficiency is generally classified into three phenotypes based on onset time, but the classification should be comprehensively determined based on genotype, residual enzyme activity, and clinical course, due to a lack of apparent genotype-phenotype correlation. With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form. Meanwhile, dietary management and restriction of exercise have been unnecessary for patients with the benign/asymptomatic type of VLCAD deficiency with a high fatty acid oxidation flux score. Although L-carnitine therapy for VLCAD/TFP deficiency has been controversial, supplementation with L-carnitine may be accepted for CPT2/CACT and multiple acyl-CoA dehydrogenase deficiencies. Recently, a double-blind, randomized controlled trial of triheptanoin (seven-carbon fatty acid triglyceride) versus trioctanoin (regular medium-chain triglyceride) was conducted and demonstrated improvement of cardiac functions on triheptanoin. Additionally, although the clinical efficacy of bezafibrate remains controversial, a recent open-label clinical trial showed efficacy of this drug in improving quality of life. These drugs may be promising for the treatment of FAODs, though further studies are required.",2019,"With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form.",['patients with the benign/asymptomatic type of VLCAD deficiency with a high fatty acid oxidation flux score'],"['bezafibrate', 'triheptanoin (seven-carbon fatty acid triglyceride) versus trioctanoin (regular medium-chain triglyceride']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3887523', 'cui_str': 'Acadvl'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0077030', 'cui_str': 'glycerol tricaprylate'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]",[{'cui': 'C0034380'}],,0.025148,"With the expansion of newborn screening for FAODs, several issues have arisen, such as missed detection, overdiagnosis (including detection of benign/asymptomatic type), and poor prognosis of the neonatal-onset form.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Pediatrics, Shimane University Faculty of Medicine, 89-1, Ennya, Izumo, Shimane, 693-8501, Japan. k-yamada@med.shimane-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Taketani', 'Affiliation': 'Department of Pediatrics, Shimane University Faculty of Medicine, 89-1, Ennya, Izumo, Shimane, 693-8501, Japan.'}]",Journal of human genetics,['10.1038/s10038-018-0527-7'] 1141,30893284,Intubating Laryngeal Mask Airway-assisted Flexible Bronchoscopic Intubation Is Associated With Reduced Cervical Spine Motion When Compared With C-MAC Video Laryngoscopy-guided Intubation: A Prospective Randomized Cross Over Trial.,"BACKGROUND In the evolving research into cervical spine mechanics during airway intervention, new devices are being constantly added to the armamentarium of anesthesiologists. In this study we compared cervical spine movement during orotracheal intubation using an intubating laryngeal mask airway (LMA Fastrach) assisted flexible bronchoscope or video laryngoscope. MATERIALS AND METHODS In total, 40 consenting patients without history of abnormalities of cervical spine and planned for elective neuroradiologic interventions in the angiography suite were enrolled in this randomized crossover trial. Every patient was subjected to LMA Fastrach-guided flexible bronchoscopic as well as video laryngoscopy guided intubation. Cervical spine motion at the occipital bone, C1-C5 vertebrae, the occiput-C1, C1-C2, C2-C3 and C4-C5 junctions was investigated using continuous fluoroscopy during intubation. The primary outcome of the study was combined craniocervical motion from occiput to C5 between the 2 intubation techniques. RESULTS There was less (62%) combined craniocervical movement from occiput to C5 during the LMA Fastrach-flexible bronchoscopy-guided technique as compared with video laryngoscopy-guided intubation (17.55±14.23 vs. 28.95±11.58 degrees, respectively; P<0.001). The LMA Fastrach flexible bronchoscopy-guided technique also produced significantly less movement as compared to the video laryngoscope at the occiput-C1 (9.75±8.59 vs. 15.00±10.48 degrees; P=0.000) and C1-C2 level (3.95±7.51 vs. 7.53±9.1 degrees; P=0.003). CONCLUSIONS There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.",2020,There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.,['40 consenting patients without history of abnormalities of cervical spine and planned for elective neuroradiologic interventions in the angiography suite'],"['LMA Fastrach assisted flexible bronchoscopic intubation', 'orotracheal intubation using an intubating laryngeal mask airway (LMA Fastrach) assisted flexible bronchoscope or video laryngoscope', 'Intubating Laryngeal Mask Airway-assisted Flexible Bronchoscopic Intubation', 'C-MAC Video Laryngoscopy-guided Intubation']","['Cervical spine motion', 'C1-C2 level', 'combined craniocervical motion from occiput to C5 between the 2 intubation techniques', 'craniocervical and upper cervical spine', 'cervical spine movement', 'Cervical Spine Motion']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope (physical object)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1562228', 'cui_str': 'Intubation technique'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",40.0,0.157069,There was significantly less movement in the craniocervical and upper cervical spine during LMA Fastrach assisted flexible bronchoscopic intubation compared to video laryngoscopic intubation.,"[{'ForeName': 'Amlan', 'Initials': 'A', 'LastName': 'Swain', 'Affiliation': 'Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anaesthesia and Intensive Care.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Radiodiagnosis and Imaging.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Salunke', 'Affiliation': 'Neurosurgery, PGIMER.'}, {'ForeName': 'Nidhi B', 'Initials': 'NB', 'LastName': 'Panda', 'Affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Seelora', 'Initials': 'S', 'LastName': 'Sahu', 'Affiliation': 'Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000583'] 1142,31706541,Autologous Platelet-Rich Gel for the Treatment of Diabetic Sinus Tract Wounds: A Clinical Study.,"BACKGROUND The aim of this study was to evaluate the efficacy of autologous platelet-rich gel (APG) in the treatment of deep sinus tract wounds from diabetic ulcers. METHODS Forty-eight patients with diabetic ulcers were randomly classified into two groups: an APG treatment group (25 patients) and a conventional wound dressing control group (23 patients). The sinus tract closure times, ulcer healing rates, hospitalization times, and hospitalization expenses of the two groups were compared. RESULTS There were no significant differences in the basic data and wound conditions between the two groups. The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively. During the first 4 wk, the sinus tract closure rate for the APG group was significantly higher than that for the control group. However, there was no significant difference in the sinus tract healing between the two groups at the end of the 8th wk. For the APG group and the control group, the average hospital stays were 19.36 ± 7.239 d and 48.13 ± 11.721 d, respectively, and the total hospitalization expenses were 2.48 ± 0.45 ten thousand yuan and 5.63 ± 1.35 ten thousand yuan (P < 0.05), respectively. These differences were statistically significant. CONCLUSIONS When compared with conventional wound dressings, APG can accelerate the healing of deep sinus tract wounds associated with diabetic ulcers.",2020,"The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively.","['deep sinus tract wounds from diabetic ulcers', 'Diabetic Sinus Tract Wounds', 'Forty-eight patients with diabetic ulcers']","['APG treatment', 'autologous platelet-rich gel (APG', 'conventional wound dressing control', 'Autologous Platelet-Rich Gel']","['basic data and wound conditions', 'average hospital stays', 'sinus tract closure rate', 'cure (healed wound) rates', 'sinus tract closure times, ulcer healing rates, hospitalization times, and hospitalization expenses', 'total hospitalization expenses', 'sinus tract healing']","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0743150', 'cui_str': 'Diabetic ulcer'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1265679', 'cui_str': 'Wound, healed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",48.0,0.0124028,"The cure (healed wound) rates were 96% and 87% for the APG group and control group, respectively.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China; Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China; Department of Plastic and Reconstructive Surgery, Anqing municipal hospital, Anqing, Anhui Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China. Electronic address: zhaoyuaps@163.com.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.'}]",The Journal of surgical research,['10.1016/j.jss.2019.09.069'] 1143,31698293,Medication error encouragement training: A quasi-experimental study.,"BACKGROUND Medication errors are the most common clinical errors in healthcare practice and can lead to serious consequences. Medication error encouragement training (MEET) brings students face-to-face with potential errors in the medication process, in a safe environment where they are encouraged to understand both the error and the context in which it occurred. OBJECTIVES The study aimed to examine the effects of a MEET intervention on medication safety confidence among nursing undergraduates. DESIGN This was a quasi-experimental study with a nonequivalent control group design. PARTICIPANTS Our sample was recruited from the nursing education department of a university, with 47 participants randomly assigned to the experimental group, and 50 to the control group. METHODS Both groups received theoretical training, followed by applied training. The experimental group received the MEET intervention developed specifically for this study, while the control group received traditional error avoidance training. Participants' medication administration confidence was measured pre- and post-intervention. RESULTS Following training, the experimental group's confidence was significantly higher than that of the control group. With regard to individual medication administration procedures, the experimental groups' medication safety confidence increased significantly after training compared to the control group in patient identification, drug information confirmation, and drug preparation. CONCLUSIONS Introducing MEET into nursing curricula could reduce medication errors and related complications in healthcare institutions. Further studies are needed to investigate the long-term effects of MEET interventions, as well as the generalizability of our findings.",2020,"With regard to individual medication administration procedures, the experimental groups' medication safety confidence increased significantly after training compared to the control group in patient identification, drug information confirmation, and drug preparation. ","['Our sample was recruited from the nursing education department of a university, with 47 participants randomly assigned to the experimental group, and 50 to the control group', 'nursing undergraduates']","['theoretical training, followed by applied training', 'MEET intervention', 'traditional error avoidance training']",['medication safety confidence'],"[{'cui': 'C0013636', 'cui_str': 'Education, Nursing'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.0177449,"With regard to individual medication administration procedures, the experimental groups' medication safety confidence increased significantly after training compared to the control group in patient identification, drug information confirmation, and drug preparation. ","[{'ForeName': 'Kyoungja', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Hannam University, Daejeon, South Korea. Electronic address: asteria43@hnu.kr.'}, {'ForeName': 'Insook', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Hannam University, Daejeon, South Korea.'}]",Nurse education today,['10.1016/j.nedt.2019.104250'] 1144,28444518,Video-Based Approach to Engaging Parents into a Preventive Parenting Intervention for Divorcing Families: Results of a Randomized Controlled Trial.,"The public health impact of evidence-based, preventive parenting interventions has been severely constrained by low rates of participation when interventions are delivered under natural conditions. It is critical that prevention scientists develop effective and feasible parent engagement methods. This study tested video-based methods for engaging parents into an evidence-based program for divorcing parents. Three alternative versions of a video were created to test the incremental effectiveness of different theory-based engagement strategies based on social influence and health behavior models. A randomized controlled trial was conducted to compare the three experimental videos versus two control conditions, an information-only brochure and an information-only video. Participants were attendees at brief, court-mandated parent information programs (PIPs) for divorcing or never married, litigating parents. Of the 1123 eligible parents, 61% were female and 13% were never married to the child's other parent. Randomization to one of five conditions was conducted at the PIP class level, blocking on facilitator. All participants completed a 15-item, empirically validated risk index and an invitation form. Results of regression analyses indicated that the most streamlined version, the core principles video, significantly increased parents' interest in participating in the parenting intervention, enrollment during a follow-up call, and initiation (i.e., attending at least one session) compared to one or the other control conditions. Findings suggest that videos based on social influence and health behavior theories could provide an effective and feasible method for increasing parent engagement, which would help maximize the public health benefits of evidence-based parenting interventions.",2018,"Results of regression analyses indicated that the most streamlined version, the core principles video, significantly increased parents' interest in participating in the parenting intervention, enrollment during a follow-up call, and initiation (i.e., attending at least one session) compared to one or the other control conditions.","['Participants were attendees at brief, court-mandated parent information programs (PIPs) for divorcing or never married, litigating parents', ""1123 eligible parents, 61% were female and 13% were never married to the child's other parent"", 'engaging parents into an evidence-based program for divorcing parents', 'Divorcing Families']","['Video-Based Approach to Engaging Parents into a Preventive Parenting Intervention', 'information-only brochure and an information-only video']",[],"[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0027952', 'cui_str': 'Never Married'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0425149', 'cui_str': 'Divorced parents (family) (social concept)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]",[],1123.0,0.0653508,"Results of regression analyses indicated that the most streamlined version, the core principles video, significantly increased parents' interest in participating in the parenting intervention, enrollment during a follow-up call, and initiation (i.e., attending at least one session) compared to one or the other control conditions.","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Winslow', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA. emily.winslow@asu.edu.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Braver', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cialdini', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Betkowski', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Hita', 'Affiliation': 'School of Social and Behavioral Sciences, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bapat', 'Affiliation': 'Willowstone Family Services, Lafayette, IN, USA.'}, {'ForeName': 'Lorey', 'Initials': 'L', 'LastName': 'Wheeler', 'Affiliation': 'Nebraska Center for Research on Children, Youth, Families and Schools, University of Nebraska-Lincoln, Lincoln, NE, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Lopez', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-017-0791-3'] 1145,30936043,Training gains and transfer effects after mnemonic strategy training in mild cognitive impairment: A fMRI study.,"Prior work has revealed that mnemonic strategy training (MST) can enhance memory for specific content and engages regions in the frontoparietal cognitive control network. Evidence of transfer to novel content is less clear. Here, we provide secondary analysis of functional magnetic resonance imaging (fMRI) data acquired during a randomized controlled trial that compared MST to an active education control condition in patients with amnestic mild cognitive impairment (a-MCI). In the trial, thirty participants with a-MCI were randomized to the education program (EP) or MST, where they learned to apply the technique to face-name associations during four intervening hour long training sessions. Participants underwent pre- and post-training fMRI scans, during which they encoded both the trained (i.e., those used during the four training sessions) and untrained ('novel') face-name associations. The primary cognitive outcome measures revealed significantly improved memory for both trained and novel stimuli - effects supporting near transfer of MST. Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing. Critically, this pattern of activation was notably different from the EP group. Thus, the changes in activation were consistent with the strategies trained and, combined with the cognitively-based near transfer effects, suggest that MST focused on face-name association enhances performance by engaging cognitive control and social/emotional processing. Finally, our data indicated that our MST is a relevant and efficient intervention to a-MCI.",2020,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","['thirty participants with a-MCI', 'patients with amnestic mild cognitive impairment (a-MCI', 'mild cognitive impairment']","['mnemonic strategy training', 'MST', 'education program (EP) or MST', 'mnemonic strategy training (MST']","['memory for both trained and novel stimuli - effects supporting near transfer of MST', 'social cognition and emotional processing']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",30.0,0.0303448,"Relative to pre-training, there were significant and highly similar increases in activation for both trained and novel stimuli, especially in regions associated with the frontoparietal cognitive control network bilaterally, but also in temporal areas related to social cognition and emotional processing.","[{'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Simon', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: sharon.sanzsimon@gmail.com.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Division of Neuropsychology, Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA; VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Mariana P', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Fábio L S', 'Initials': 'FLS', 'LastName': 'Duran', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Fonseca', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria da Graça M', 'Initials': 'MDGM', 'LastName': 'Martin', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ávila', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fábio H G', 'Initials': 'FHG', 'LastName': 'Porto', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sônia M D', 'Initials': 'SMD', 'LastName': 'Brucki', 'Affiliation': 'Department of Neurology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Department of Preventive Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lyssandra S', 'Initials': 'LS', 'LastName': 'Tascone', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil; Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edson', 'Initials': 'E', 'LastName': 'Amaro', 'Affiliation': 'Neuroimagem funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Geraldo F', 'Initials': 'GF', 'LastName': 'Busatto', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cássio M C', 'Initials': 'CMC', 'LastName': 'Bottino', 'Affiliation': 'Old Age Research Group (PROTER), Department and Institute of Psychiatry, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.03.014'] 1146,31710306,An Interactive Parent-Targeted Text Messaging Intervention to Improve Oral Health in Children Attending Urban Pediatric Clinics: Feasibility Randomized Controlled Trial.,"BACKGROUND Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children. OBJECTIVE This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes. METHODS Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed-effects models. RESULTS A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child's teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children's teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; P=.45) and self-efficacy (F1,53=0.24; P=.63) to engage in oral health behaviors, favoring OHT (d=0.28 and d=0.16 for motivation and self-efficacy, respectively). CONCLUSIONS The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.",2019,Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range).,"['Attending Urban Pediatric Clinics', 'Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to', '55 participants', 'Children']","['CWT', 'OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages', 'oral health text messages (OHT', 'CWT, OHT', 'OHT program', 'Interactive Parent-Targeted Text Messaging Intervention']","[""child's oral health, and knowledge of their child's oral health needs"", 'changes in motivation', 'Response rates', 'Overall program likeability scores', 'overall program satisfaction', 'attitudes regarding the use of fluoride', 'pediatric oral health behaviors', 'self-efficacy', 'oral health behaviors']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0860094', 'cui_str': 'Below poverty line'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0029162'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029162'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",55.0,0.0707227,Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range).,"[{'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Center for Behavioral Science Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Henshaw', 'Affiliation': 'Center for Research to Evaluate & Eliminate Dental Disparities, Department of Health Policy & Health Services Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'Romano', 'Initials': 'R', 'LastName': 'Endrighi', 'Affiliation': 'Center for Behavioral Science Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Adams', 'Affiliation': 'Department of Pediatrics, Boston Medical Center & Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Heeren', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Rochelle K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bock', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Werntz', 'Affiliation': 'Agile Health, Inc, Lincolnshire, IL, United States.'}]",JMIR mHealth and uHealth,['10.2196/14247'] 1147,30871958,Effect of weight-bearing wrist movement with carpal-stabilizing taping on pain and range of motion in subjects with dorsal wrist pain: A randomized controlled trial.,"STUDY DESIGN Randomized control trial. INTRODUCTION During weight-bearing wrist movement, potential stabilizing forces caused by carpal stabilizing taping (CST) may restrict movement of the carpal bones, allowing greater wrist joint extension. PURPOSE OF THE STUDY The purpose of study was to investigate the effect of CST during weight-bearing wrist movement on pain intensity and range of motion (ROM) of wrist extension in subjects with dorsal wrist pain. METHODS Thirty participants with dorsal wrist pain when weight bearing through the hand were randomly allocated into 2 groups: (1) a CST group using rigid tape and (2) placebo taping (PT) group using elastic tape. Subjects performed weight-bearing wrist movements with CST or PT in 6 sessions for 1 week. Active and passive ROM (AROM and PROM), and the visual analog scale (VAS) were assessed at baseline and after the intervention. RESULTS The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01). Comparing the PT and CST groups, the differences between preintervention and postintervention AROM (mean difference [MD] = +8.6°) and PROM (MD = +6.8°) were significantly greater in the CST group than in the PT group (P < .01). The CST group also showed greater improvement in VAS compared with the PT group (MD = -18 mm) (P < .01). CONCLUSION We recommend CST during weight-bearing wrist movement as an effective intervention for both increasing wrist extension ROM and decreasing pain in patients with dorsal wrist pain during weight bearing through the hand.",2020,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"['subjects with dorsal wrist pain', 'patients with dorsal wrist pain during weight bearing through the hand', 'Thirty participants with dorsal wrist pain when weight bearing through the hand']","['CST', 'carpal stabilizing taping (CST', 'CST or PT', 'CST group using rigid tape and (2) placebo taping (PT) group using elastic tape', 'weight-bearing wrist movement with carpal-stabilizing taping']","['pain intensity and range of motion (ROM) of wrist extension', 'preintervention and postintervention AROM', 'AROM and PROM of wrist extension', 'PROM', 'Active and passive ROM (AROM and PROM), and the visual analog scale (VAS', 'VAS', 'pain and range of motion']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0221785', 'cui_str': 'Wrist joint pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0586489,The AROM and PROM of wrist extension increased significantly in both groups compared with preintervention values (P < .01).,"[{'ForeName': 'Geun-Su', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of KEMA Therapy, Graduate School of Humanities Industry, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Jong-Hyuck', 'Initials': 'JH', 'LastName': 'Weon', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea.'}, {'ForeName': 'Moon-Hwan', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Wonju Christian Hospital, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Koh', 'Affiliation': 'Department of Physical Therapy, Masan University, Changwon, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Jung', 'Affiliation': 'Department of Physical Therapy, College of Health & Welfare, Kinesiopathologic Science Institute, Joongbu University, Geumsan, Republic of Korea. Electronic address: ptsports@joongbu.ac.kr.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.02.001'] 1148,30938299,"Maternal pertussis vaccination and its effects on the immune response of infants aged up to 12 months in the Netherlands: an open-label, parallel, randomised controlled trial.","BACKGROUND Maternal tetanus, diphtheria, and acellular pertussis (Tdap) vaccination offers protection for neonates against clinical pertussis until primary vaccinations, but maternal antibodies also interfere with infants' immune responses to primary vaccinations. We investigated the effect of maternal Tdap vaccination on the pertussis antibody responses of infants starting primary vaccinations at age 3 months. METHODS In an open-label, parallel, randomised, controlled trial, pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group). All term-born infants were vaccinated with the diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine at 3 months, 5 months, and 11 months. Randomisation was done using a number generator in a 1:1 ratio and with sealed envelopes. Participants and clinical trial staff were not masked, but laboratory technicians were unaware of study group assignments. The primary endpoint was serum IgG pertussis toxin antibody concentrations at age 3 months. Cord blood and infant blood samples were collected at age 2 months, 3 months, 6 months, 11 months, and 12 months. Analysis was done by modified intention to treat with all randomly assigned participants in case a laboratory result was available. This trial is registered with ClinicaltTrialsRegister.eu (EudraCT 2012-004006-9) and trialregister.nl (NTR number NTR4314). The trial is now closed to new participants. FINDINGS Between Jan 16, 2014, and March 4, 2016, 118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group. The geometric mean concentration (GMC) of pertussis toxin antibodies were higher in infants in the maternal Tdap group than in the control group infants at age 3 months (GMC ratio 16·6, 95% CI 10·9-25·2) and also significantly higher compared with control infants at age 2 months. After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group. No safety issues after maternal Tdap vaccination were encountered. INTERPRETATION In view of the high pertussis toxin antibody concentrations at age 3 months, maternal vaccination supports a delay of the first pertussis vaccination in infants until at least age 3 months. Maternal antibody interference affects antibody concentrations after primary and booster vaccinations. The clinical consequences of this interference remain to be established. FUNDING The Dutch Ministry of Health, Welfare, and Sport.",2019,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","['118 pregnant women were enrolled into our study, with 58 in the maternal Tdap group and 60 in the control group', 'infants starting primary vaccinations at age 3 months', 'pregnant women aged 18-40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics in the Netherlands and received', 'infants aged up to 12 months in the Netherlands', 'Between Jan 16, 2014, and March 4, 2016']","['maternal Tdap vaccination', 'diphtheria, and acellular pertussis (Tdap) vaccination', 'Tdap vaccination either at 30-32 weeks of pregnancy (maternal Tdap group) or within 48 h after delivery (control group', 'diphtheria, tetanus, and pertussis-inactivated poliomyelitis-Haemophilus influenzae type B-hepatitis B six-in-one vaccine and a ten-valent pneumococcal vaccine']","['Maternal antibody interference affects antibody concentrations', 'antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin', 'serum IgG pertussis toxin antibody concentrations', 'geometric mean concentration (GMC) of pertussis toxin antibodies', 'Cord blood and infant blood samples']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}]","[{'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0020731', 'cui_str': 'Histamine-Sensitizing Factor'}, {'cui': 'C0136166', 'cui_str': 'pertactin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",118.0,0.177939,"After primary vaccinations, antibody concentrations for pertussis toxin, filamentous haemagglutinin, and pertactin were significantly lower at all timepoints in infants of the maternal Tdap group than in infants in the control group.","[{'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Barug', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Pronk', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Marlies A', 'Initials': 'MA', 'LastName': 'van Houten', 'Affiliation': 'Department of Paediatrics, Spaarne Hospital, Hoofddorp, Netherlands.'}, {'ForeName': 'Florens G A', 'Initials': 'FGA', 'LastName': 'Versteegh', 'Affiliation': ""University Groningen, University Medical Centre Groningen/Beatrix Children's Hospital, Groningen, Netherlands.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Knol', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van de Kassteele', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'Berbers', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Elisabeth A M', 'Initials': 'EAM', 'LastName': 'Sanders', 'Affiliation': ""Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands; Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, Utrecht, Netherlands.""}, {'ForeName': 'Nynke Y', 'Initials': 'NY', 'LastName': 'Rots', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands. Electronic address: nynke.rots@rivm.nl.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30717-5'] 1149,32407239,Effect of histamine-receptor antagonism on leg blood flow during exercise.,"Histamine mediates vasodilation during inflammatory and immune responses, as well as following endurance exercise. During exercise, intramuscular histamine concentration increases, and its production, appears related to exercise intensity and duration. However, whether histamine contributes to exercise hyperemia and promotes exercise blood flow in an intensity- or duration-dependent pattern is unknown. The purpose of this study was to compare leg blood flow across a range of exercise intensities, before and after prolonged exercise, with and without histamine-receptor antagonism. It was hypothesized that combined oral histamine H 1 /H 2 -receptor antagonism would decrease leg blood flow, and the effect would be greater at higher intensities and following prolonged exercise. Sixteen (7F, 9M) volunteers performed single-leg knee-extension exercise after consuming either placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade). Exercise consisted of two graded protocols at 20, 40, 60, and 80% of peak power, separated by 60 min of knee-extension exercise at 60% of peak power. Femoral artery blood flow was measured by ultrasonography. Femoral artery blood flow increased with exercise intensity up to 2,660 ± 97 mL/min at 80% of peak power during Placebo ( P < 0.05). Blood flow was further elevated with Blockade to 2,836 ± 124 mL/min ( P < 0.05) at 80% peak power (9.1 ± 4.8% higher than placebo). These patterns were not affected by prolonged exercise ( P = 0.13). On average, femoral blood flow during prolonged exercise was 12.7 ± 2.8% higher with Blockade vs. Placebo ( P < 0.05). Contrary to the hypothesis, these results suggest that histamine receptor antagonism during exercise, regardless of intensity or duration, increases leg blood flow measured by ultrasonography. NEW & NOTEWORTHY Leg blood flow during exercise was increased by taking antihistamines, which block the receptors for histamine, a molecule often associated with inflammatory and immune responses. The elevated blood flow occurred over exercise intensities ranging from 20 to 80% of peak capacity and during exercise of 60 min duration. These results suggest that exercise-induced elevations in histamine concentrations are involved in novel, poorly understood, and perhaps complex ways in the exercise response.",2020,Blood flow was further elevated with Blockade to 2836±124 ml·min -1 (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,[],"['Placebo', 'single-leg knee-extension exercise after consuming either Placebo or combined histamine H 1 /H 2 -receptor antagonists (Blockade', 'histamine-receptor antagonism', 'histamine', 'Histamine']","['leg blood flow', 'Blood flow', 'Femoral artery blood flow', 'femoral blood flow']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0034813', 'cui_str': 'Histamine receptor'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.0688832,Blood flow was further elevated with Blockade to 2836±124 ml·min -1 (P<0.05) at 80% peak power (9.1 ± 4.8% higher than Placebo).,"[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00689.2019'] 1150,30900195,A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial.,"Parents of children with Autism experience high levels of stress. Resiliency is the ability to cope and adapt when faced with stressful events. This randomized, waitlist controlled pilot trial examines the feasibility, acceptability, and preliminary efficacy of an adapted virtual mind-body group intervention for parents of children with ASD. The intervention was feasible and acceptable. The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively). Findings showed promising feasibility, acceptability, and preliminary efficacy for parents of children with ASD.",2019,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","['parents of children with ASD', 'Parents of children with Autism experience high levels of stress', 'Parents of Children with Autism']","['adapted virtual mind-body group intervention', 'Virtual Resiliency Intervention']","['resiliency and stress reactivity/coping relative', 'distress']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0497679,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kuhlthau', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA. kkuhlthau@mgh.harvard.edu.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chad-Friedman', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Proszynski', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03976-4'] 1151,30900194,Effects of Dog Assisted Therapy for Adults with Autism Spectrum Disorder: An Exploratory Randomized Controlled Trial.,"Effective treatments of highly prevalent stress-related outcomes such as depression and anxiety are understudied in adults with autism spectrum disorder (ASD). A randomized controlled trial with baseline, post-intervention, and 10-week follow-up, that explores the effects of animal assisted therapy (AAT) was conducted. In total, 53 adults with ASD with normal to high intelligence were randomized in an intervention (N = 27) versus waiting list control group (N = 26). The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.",2020,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","['Spectrum Disorder', '53 adults with ASD with normal to high intelligence', 'Adults with Autism', 'adults with autism spectrum disorder (ASD', 'adults with ASD with normal to high intelligence']","['waiting list control', 'animal assisted therapy (AAT', 'Dog Assisted Therapy']",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150133', 'cui_str': 'Animal Facilitated Therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],53.0,0.0770418,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","[{'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Wijker', 'Affiliation': 'GGZ Oost Brabant, P.O. Box 3, 5427 ZG, Boekel, The Netherlands. carolien.wijker@ou.nl.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Leontjevas', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Spek', 'Affiliation': 'Autism Center of Expertise, Eemnes, The Netherlands.'}, {'ForeName': 'Marie-Jose', 'Initials': 'MJ', 'LastName': 'Enders-Slegers', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03971-9'] 1152,30585829,Effects of Baseline Thrombocytopenia and Platelet Decrease Following Renal Replacement Therapy Initiation in Patients With Severe Acute Kidney Injury.,"OBJECTIVES Thrombocytopenia is common in critically ill patients with severe acute kidney injury and may be worsened by the use of renal replacement therapy. In this study, we evaluate the effects of renal replacement therapy on subsequent platelet values, the prognostic significance of a decrease in platelets, and potential risk factors for platelet decreases. DESIGN Post hoc analysis of the Acute Renal Failure Trial Network Study. SETTING The Acute Renal Failure Trial Network study was a multicenter, prospective, randomized, parallel-group trial of two strategies for renal replacement therapy in critically ill patients with acute kidney injury conducted between November 2003 and July 2007 at 27 Veterans Affairs and university-affiliated medical centers. SUBJECTS The Acute Renal Failure Trial Network study evaluated 1,124 patients with severe acute kidney injury requiring renal replacement therapy. INTERVENTIONS Predictor variables were thrombocytopenia at initiation of renal replacement therapy and platelet decrease following renal replacement therapy initiation. MEASUREMENTS AND MAIN RESULTS Outcomes were mortality at 28 days, 60 days, and 1 year, renal recovery, renal replacement therapy free days, ICU-free days, and hospital-free days. Baseline thrombocytopenia in patients requiring renal replacement therapy was associated with increased mortality and was also associated with lower rates of renal recovery. A decrease in platelet values following renal replacement therapy initiation was associated with increased mortality. Continuous renal replacement therapy was not an independent predictor of worsening thrombocytopenia compared with those treated with intermittent hemodialysis. CONCLUSIONS Baseline thrombocytopenia and platelet decrease following renal replacement therapy initiation were associated with increased mortality, and baseline thrombocytopenia was associated with decreased rates of renal recovery. Continuous renal replacement therapy did not decrease platelets compared with hemodialysis.",2019,Baseline thrombocytopenia in patients requiring renal replacement therapy was associated with increased mortality and was also associated with lower rates of renal recovery.,"['critically ill patients with severe acute kidney injury', 'patients requiring renal replacement therapy', 'critically ill patients with acute kidney injury conducted between November 2003 and July 2007 at 27 Veterans Affairs and university-affiliated medical centers', '1,124 patients with severe acute kidney injury requiring renal replacement therapy', 'Patients With Severe Acute Kidney Injury']","['Renal Replacement Therapy Initiation', 'renal replacement therapy', 'Continuous renal replacement therapy']","['mortality at 28 days, 60 days, and 1 year, renal recovery, renal replacement therapy free days, ICU-free days, and hospital-free days', 'worsening thrombocytopenia', 'platelet values', 'rates of renal recovery', 'mortality, and baseline thrombocytopenia', 'Baseline Thrombocytopenia and Platelet Decrease', 'Baseline thrombocytopenia', 'renal recovery', 'mortality']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy (procedure)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}]",1124.0,0.195652,Baseline thrombocytopenia in patients requiring renal replacement therapy was associated with increased mortality and was also associated with lower rates of renal recovery.,"[{'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Griffin', 'Affiliation': 'Division of Renal Diseases and Hypertension/Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': 'Division of Renal Diseases and Hypertension/Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Division of Renal Diseases and Hypertension/Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section/Medical Service, VA Pittsburgh HCS and Renal-Electrolyte Division/Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Faubel', 'Affiliation': 'Division of Renal Diseases and Hypertension/Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jalal', 'Affiliation': 'Division of Nephrology/Department of Medicine, University of Iowa, Iowa City, IA.'}]",Critical care medicine,['10.1097/CCM.0000000000003598'] 1153,30858014,"An environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multicentre, randomised trial.","BACKGROUND The hospital environment is a reservoir for the transmission of microorganisms. The effect of improved cleaning on patient-centred outcomes remains unclear. We aimed to evaluate the effectiveness of an environmental cleaning bundle to reduce health care-associated infections in hospitals. METHODS The REACH study was a pragmatic, multicentre, randomised trial done in 11 acute care hospitals in Australia. Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme. The stepped-wedge design meant intervention periods varied from 20 weeks to 50 weeks. We introduced the REACH cleaning bundle, a multimodal intervention, focusing on optimising product use, technique, staff training, auditing with feedback, and communication, for routine cleaning. The primary outcomes were incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection. The secondary outcome was the thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTRN12615000325505. FINDINGS Between May 9, 2016, and July 30, 2017, we implemented the cleaning bundle in 11 hospitals. In the pre-intervention phase, there were 230 cases of vancomycin-resistant enterococci infection, 362 of S aureus bacteraemia, and 968 C difficile infections, for 3 534 439 occupied bed-days. During intervention, there were 50 cases of vancomycin-resistant enterococci infection, 109 of S aureus bacteraemia, and 278 C difficile infections, for 1 267 134 occupied bed-days. After the intervention, vancomycin-resistant enterococci infections reduced from 0·35 to 0·22 per 10 000 occupied bed-days (relative risk 0·63, 95% CI 0·41-0·97, p=0·0340). The incidences of S aureus bacteraemia (0·97 to 0·80 per 10 000 occupied bed-days; 0·82, 0·60-1·12, p=0·2180) and C difficile infections (2·34 to 2·52 per 10 000 occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly. The intervention increased the percentage of frequent touch points cleaned in bathrooms from 55% to 76% (odds ratio 2·07, 1·83-2·34, p<0·0001) and bedrooms from 64% to 86% (1·87, 1·68-2·09, p<0·0001). INTERPRETATION The REACH cleaning bundle was successful at improving cleaning thoroughness and showed great promise in reducing vancomycin-resistant enterococci infections. Our work will inform hospital cleaning policy and practice, highlighting the value of investment in both routine and discharge cleaning practice. FUNDING National Health and Medical Research Council (Australia).",2019,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","['hospitals (REACH', '11 acute care hospitals in Australia', 'hospitals', 'Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme', 'Between May 9, 2016, and July 30, 2017']",['environmental cleaning bundle'],"['incidences of S aureus bacteraemia', 'incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection', 'percentage of frequent touch points cleaned', 'C difficile infections', 'vancomycin-resistant enterococci infections', 'thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0419786', 'cui_str': 'Infection surveillance (regime/therapy)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia caused by Staphylococcus aureus'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]",,0.165914,"occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly.","[{'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Nursing and Health, Avondale College, Wahroonga, NSW, Australia; School of Nursing and Midwifery, University of Newcastle, Newcastle, NSW, Australia. Electronic address: brett.mitchell@avondale.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'School of Public Health, University of Queensland, Herston, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.""}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Riley', 'Affiliation': 'School of Biomedical Sciences, The University of Western Australia, Crawley, WA, Australia; School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia; School of Veterinary and Life Sciences, Murdoch University, Murdoch, WA, Australia; PathWest Laboratory Medicine, QEII Medical Centre, Nedlands, WA, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Gericke', 'Affiliation': 'School of Clinical Medicine, University of Queensland, Herston, QLD, Australia; College of Public Health, Medical and Veterinary Sciences and College of Medicine and Dentistry, James Cook University, Cairns, QLD, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia; School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, QLD, Australia.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30714-X'] 1154,30793422,Comparing the effectiveness of integrating ergonomics and motor control to conventional treatment for pain and functional recovery of work-related neck-shoulder pain: A randomized trial.,"BACKGROUND Work-related neck and shoulder pain (WRNSP) is highly prevalent among patients who seek physiotherapy treatment. Clinicians may tend to focus on teaching home exercises and provide general advice about workplace improvement. The present study investigates the short- and long-term impact of an intervention approach that emphasizes on integrating the motor control re-education with ergonomic advice. METHODS Participants diagnosed with WRNSP (n = 101) were randomly assigned into two groups in this randomized controlled trial. The Ergo-motor Group (EM, n = 51) received an integrated intervention with ergonomic advice/modifications and motor control training individualized for each participant based on their specific work demands. Control Group (CO, n = 50) received treatment for pain relief and general exercises of their necks at a designated physiotherapy clinic. Neck pain intensity and functional outcome measures were assessed before, immediately and 1-year after the 12-week intervention programmes. Global Rating of Change Score was used to evaluate the perceived recovery at 1-year follow-up. RESULTS Both groups reported significant reductions in pain and functional disability scores at post-intervention (EM, n = 44; CO, n = 42) and 1-year follow-up (EM, n = 40; CO, n = 38); however, no significant between-group differences were found (p > 0.05). Significantly higher rating in global recovery score was reported in EM group at 1-year follow-up (p < 0.05). CONCLUSIONS Intervention integrating ergonomic advice/modification with motor control exercise was found to be equally effective as pain relief and general exercise for pain and functional recovery. However, at 1-year follow-up, such integrated approach resulted in significantly better global recovery perceived by people with WRNSP. SIGNIFICANCE Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability. The Ergo-motor Group reported significantly better perceived overall recovery at 1-year follow-up.",2019,"Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability.","['patients who seek physiotherapy treatment', 'patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability', 'pain and functional recovery of work-related neck-shoulder pain', 'Participants diagnosed with WRNSP (n\xa0=\xa0101']","['motor control exercise', 'integrated intervention with ergonomic advice/modifications and motor control training individualized', 'conventional physiotherapy', 'Integrating ergonomic intervention and motor control training', 'Control Group (CO, n\xa0=\xa050) received treatment for pain relief and general exercises of their necks at a designated physiotherapy clinic', 'integrating ergonomics and motor control to conventional treatment']","['pain and functional disability scores', 'pain and functional outcomes', 'pain relief and general exercise for pain and functional recovery', 'Global Rating of Change Score', 'global recovery', 'Neck pain intensity and functional outcome measures', 'global recovery score', 'overall recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0556554', 'cui_str': 'Ergonomic education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.137233,"Integrating ergonomic intervention and motor control training achieved similar reduction in pain and functional outcomes compared to conventional physiotherapy at post-intervention and at 1-year follow-up, for patients with moderate level of work-related neck-shoulder pain and mild degree of functional disability.","[{'ForeName': 'Sharon M H', 'Initials': 'SMH', 'LastName': 'Tsang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Billy C L', 'Initials': 'BCL', 'LastName': 'So', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Rufina W L', 'Initials': 'RWL', 'LastName': 'Lau', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Grace P Y', 'Initials': 'GPY', 'LastName': 'Szeto', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1381'] 1155,30940423,Eating Pleasure in a Sample of Obese Brazilian Women: A Qualitative Report of an Interdisciplinary Intervention Based on the Health at Every Size Approach.,"INTRODUCTION Health at Every Size (HAES) is a weight-neutral approach focused on promoting healthy behaviors in people with different body sizes and on enhancing pleasure derived from consuming food to achieve sustainable healthy eating outcomes. However, to the best of our knowledge, there are no studies in the literature assessing the effects of the HAES approach on perceptions of eating pleasure. OBJECTIVE We qualitatively investigated the perceptions of obese women about eating pleasure before and after a new interdisciplinary, nonprescriptive intervention based on the HAES approach. DESIGN The intervention was a randomized controlled clinical trial, designated as Health and Wellness in Obesity, conducted over 7 months at University of São Paulo (Brazil). We used a qualitative approach to data construction and analysis of perceptions about eating pleasure. Participants were randomized to either the intervention (I-HAES) group or the control (CTRL) group. The I-HAES group featured individual nutritional counseling, group practice of enjoyable physical activity, and philosophical workshops. The CTRL group was a traditional HAES intervention group (lecture-based model). Focus group discussions eliciting perceptions of pleasure around eating were conducted at baseline and post-study. Focus group transcripts were analyzed by exploratory content analysis. PARTICIPANTS Forty-three women aged 25 to 50 years with body mass index (measured in kilograms per square meter) between 30 and 39. 9 completed the intervention and the focus groups, with 32 in the I-HAES group and 11 in the CTRL group. RESULTS Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study. The I-HAES group also displayed a greater sense of autonomy related to eating, increased pleasure in commensality, familiarity with the practice of cooking, and decreased automatic eating. CONCLUSION HAES-based intervention featuring nutritional counseling, appreciation for physical activity, and philosophical engagement was shown to stimulate pleasure around eating without leading to indiscriminate eating.",2019,"RESULTS Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study.","['Forty-three women aged 25 to 50 years with body mass index (measured in kilograms per square meter) between 30 and 39', 'obese women about eating pleasure before and after a new interdisciplinary, nonprescriptive intervention based on the HAES approach', 'Obese Brazilian Women']","['HAES approach', 'individual nutritional counseling, group practice of enjoyable physical activity, and philosophical workshops', 'intervention (I-HAES) group or the control (CTRL', 'Interdisciplinary Intervention', 'traditional HAES intervention', 'CTRL']","['sense of autonomy related to eating, increased pleasure in commensality, familiarity with the practice of cooking, and decreased automatic eating', 'Eating Pleasure']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0457242', 'cui_str': 'square metres'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]",43.0,0.0456352,"RESULTS Lack of guilt about experiencing pleasure while eating and increased reflection on their own desires increased in participants of both groups after the study.","[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Sabatini', 'Affiliation': ''}, {'ForeName': 'Mariana D', 'Initials': 'MD', 'LastName': 'Ulian', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Perez', 'Affiliation': ''}, {'ForeName': 'Ana Jéssica', 'Initials': 'AJ', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Vessoni', 'Affiliation': ''}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Aburad', 'Affiliation': ''}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lopes de Campos-Ferraz', 'Affiliation': ''}, {'ForeName': 'Desire', 'Initials': 'D', 'LastName': 'Coelho', 'Affiliation': ''}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'de Morais Sato', 'Affiliation': ''}, {'ForeName': 'Odilon J', 'Initials': 'OJ', 'LastName': 'Roble', 'Affiliation': ''}, {'ForeName': 'Ramiro Fernandez', 'Initials': 'RF', 'LastName': 'Unsain', 'Affiliation': ''}, {'ForeName': 'Roseanne C', 'Initials': 'RC', 'LastName': 'Schuster', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': ''}, {'ForeName': 'Fernanda B', 'Initials': 'FB', 'LastName': 'Scagliusi', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.01.006'] 1156,30905495,"A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs.","STUDY DESIGN Randomized clinical trial with parallel groups. INTRODUCTION Early active mobilization programs are used after zones V and VI extensor tendon repairs; two programs used are relative motion extension (RME) orthosis and controlled active motion (CAM). Although no comparative studies exist, use of the RME orthosis has been reported to support earlier hand function. PURPOSE OF THE STUDY This randomized clinical trial investigated whether patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program. METHODS Forty-two participants with zones V-VI extensor tendon repairs were randomized into either a CAM or RME program. The Sollerman Hand Function Test (SHFT) was the primary outcome measure of hand function. Days to return to work, QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction were the secondary measures of outcome. RESULTS The RME group demonstrated better results at four weeks for the SHFT score (P = .0073; 95% CI: -10.9, -1.8), QuickDASH score (P = .05; 95% CI: -0.05, 19.5), and TAM (P = .008; 95% CI: -65.4, -10.6). Days to return to work were similar between groups (P = .77; 95% CI: -28.1, 36.1). RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4). No tendon ruptures occurred. DISCUSSION Participants managed using an RME program, and RME finger orthosis demonstrated significantly better early hand function, TAM, and orthosis satisfaction than those managed by the CAM program using a static wrist-hand-finger orthosis. This is likely due to the less restrictive design of the RME orthosis. CONCLUSIONS The RME program supports safe earlier recovery of hand function and motion when compared to a CAM program following repair of zones V and VI extensor tendons.",2020,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","['patients managed with an RME program would recover hand function earlier postoperatively than those managed with a CAM program', 'Forty-two participants with zones V-VI extensor tendon repairs']","['TAM, and orthotic satisfaction with a relative motion extension program', 'CAM or RME program', 'RME']","['SHFT score', 'QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire, total active motion (TAM), grip strength, and patient satisfaction', 'QuickDASH score', 'early hand function, TAM, and orthosis satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",42.0,0.0917648,"RME participants were more satisfied with the orthosis (P < .0001; 95% CI: 3.5, 8.4).","[{'ForeName': 'Shirley J F', 'Initials': 'SJF', 'LastName': 'Collocott', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand. Electronic address: collocotts@gmail.com.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': 'Kelly', 'Affiliation': 'School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, Middlemore Hospital, Counties Manukau Health, Otahuhu, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Myhr', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Hand Therapy, Manukau SuperClinic, Counties Manukau Health, Auckland, New Zealand.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ellis', 'Affiliation': 'Health and Rehabilitation Research Institute, School of Clinical Sciences, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2018.10.003'] 1157,30874754,Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial.,"Importance Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication. Objective To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation. Design, Setting, and Participants Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or β-blocker, with 4-year follow-up. Study dates were July 2008-September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation. Interventions Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76). Main Outcomes and Measures Primary outcome was the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis. Results Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference -6.8% [95% CI, -12.9% to -0.7%]; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group. Conclusions and Relevance Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life. Trial Registration clinicaltrialsregister.eu Identifier: 2008-001384-11.",2019,"General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003).","['patients with symptomatic atrial fibrillation', 'patients with atrial fibrillation', '4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or β-blocker, with 4-year follow-up', '79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures', '76 patients randomized to receive', 'Patients With Atrial Fibrillation', '155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial']","['catheter ablation vs antiarrhythmic medication', 'catheter ablation', 'antiarrhythmic medication', 'Interventions\n\n\nPulmonary vein isolation ablation (n\u2009=\u200979) or previously untested antiarrhythmic drugs', 'Catheter Ablation vs Antiarrhythmic Medication']","['General Health score', 'Quality of Life', 'atrial fibrillation burden', 'atrial tachycardia', 'quality of life', 'General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",155.0,0.151852,"General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003).","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Blomström-Lundqvist', 'Affiliation': 'Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sigfus', 'Initials': 'S', 'LastName': 'Gizurarson', 'Affiliation': 'Department of Molecular and Clinical Medicine/Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schwieler', 'Affiliation': 'Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Steen M', 'Initials': 'SM', 'LastName': 'Jensen', 'Affiliation': 'Heart Centre and Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Bergfeldt', 'Affiliation': 'Department of Molecular and Clinical Medicine/Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Kennebäck', 'Affiliation': 'Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Aigars', 'Initials': 'A', 'LastName': 'Rubulis', 'Affiliation': 'Department of Molecular and Clinical Medicine/Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Malmborg', 'Affiliation': 'Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Raatikainen', 'Affiliation': 'Tampere University Hospital, Heart Center, Department of Cardiology, Tampere, Finland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lönnerholm', 'Affiliation': 'Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Höglund', 'Affiliation': 'Heart Centre and Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mörtsell', 'Affiliation': 'Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden.'}]",JAMA,['10.1001/jama.2019.0335'] 1158,30885591,"Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial.","BACKGROUND Infections with Clostridium difficile are a health threat, yet no products are currently licensed for prevention of primary C difficile infections. Intravenous β-lactam antibiotics are considered to confer a high risk of C difficile infection because of their biliary excretion into the gastrointestinal tract and disruption of the gut microbiome. ribaxamase (SYN-004) is an orally administered β-lactamase that was designed to be given with intravenous β-lactam antibiotics to degrade excess antibiotics in the upper gastrointestinal tract before they disrupt the gut microbiome and lead to C difficile infection. We therefore aimed to determine whether administration of ribaxamase could prevent C difficile infection in patients being treated with intravenous ceftriaxone for a lower respiratory tract infection, thereby supporting continued clinical development. METHODS In this parallel-group, double-blind, multicentre, phase 2b, randomised placebo-controlled trial, we recruited patients who had been admitted to a hospital with a lower respiratory tract infection with a pneumonia index score of 90-130 and who were expected to be treated with ceftriaxone for at least 5 days. Patients were recruited from 54 clinical sites in the USA, Canada, Bulgaria, Hungary, Poland, Romania, and Serbia. We randomly assigned patients older than 50 years to groups (1:1) in blocks of four by use of an interactive web portal; these groups were assigned to receive either 150 mg ribaxamase or placebo four times per day during, and for 72 h after, treatment with ceftriaxone. All patients, clinical investigators, study staff, and sponsor personnel were masked to the study drug assignments. The primary endpoint was the incidence of C difficile infection, as diagnosed by the local laboratory, in patients who received at least one treatment dose, and this outcome was assessed during treatment and for 4 weeks after treatment. This study is registered with ClinicalTrials.gov, number NCT02563106. FINDINGS Between Nov 16, 2015, and Nov 10, 2016, we screened 433 patients for inclusion in the study. Of these patients, 20 (5%) patients were excluded from the study (16 [4%] patients did not meet inclusion criteria; four [1%] patients because of dosing restrictions). We enrolled and randomly assigned 413 patients to groups, of whom 207 patients were assigned to receive ceftriaxone plus ribaxamase and 206 patients were assigned to receive ceftriaxone plus placebo. However, one (<1%) patient in the ribaxamase group withdrew consent and was not treated with ribaxamase. During the study and within the 4 weeks after antibiotic treatment, two (1·0%) patients in the ribaxamase group and seven (3·4%) patients in the placebo group were diagnosed with an infection with C difficile (risk reduction 2·4%, 95% CI -0·6 to 5·9; one-sided p=0·045). Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group). This disparity was due to the higher incidence of deaths attributed to cardiac-associated causes in the ribaxamase group (six deaths vs one death in the placebo group). INTERPRETATION In patients treated with intravenous ceftriaxone for lower respiratory tract infections, oral ribaxamase reduced the incidence of C difficile infections compared with placebo. The imbalance in deaths between the groups appeared to be related to the underlying health of the patients. Ribaxamase has the potential to prevent C difficile infection in patients treated with intravenous β-lactam antibiotics, and our findings support continued clinical development of ribaxamase to prevent C difficile infection. FUNDING Synthetic Biologics.",2019,Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group).,"['patients who had been admitted to a hospital with a lower respiratory tract infection with a pneumonia index score of 90-130 and who were expected to be treated with ceftriaxone for at least 5 days', 'patients being treated with intravenous', 'and 206 patients', 'β-lactam-treated patients', 'patients older than 50 years to groups (1:1) in blocks of four by use of an interactive web portal; these groups', 'Of these patients, 20 (5%) patients were excluded from the study (16 [4%] patients did not meet inclusion criteria', '413 patients to groups, of whom 207 patients', 'Patients were recruited from 54 clinical sites in the USA, Canada, Bulgaria, Hungary, Poland, Romania, and Serbia', 'Between Nov 16, 2015, and Nov 10, 2016, we screened 433 patients for inclusion in the study', 'patients treated with intravenous']","['ceftriaxone plus placebo', 'placebo', 'intravenous ceftriaxone', '150 mg ribaxamase or placebo', 'Intravenous β-lactam antibiotics', 'ceftriaxone plus ribaxamase', 'Ribaxamase', 'β-lactam antibiotics', 'ribaxamase (SYN-004', 'ribaxamase', 'ceftriaxone']","['incidence of C difficile infection', 'deaths', 'Adverse events', 'incidence of C difficile infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0022914', 'cui_str': 'Lactams'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4310096', 'cui_str': 'SYN-004'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",207.0,0.424261,Adverse events were similar between groups but more deaths were reported in the ribaxamase group (11 deaths vs five deaths in the placebo group).,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Kokai-Kun', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA. Electronic address: jkokai-kun@syntheticbiologics.com.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Coughlin', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Chenxiong', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Whalen', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Stevenson', 'Affiliation': 'RWS Biomedical Consulting LLC, East Lyme, CT, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Wacher', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sliman', 'Affiliation': 'Synthetic Biologics, Rockville, MD, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30731-X'] 1159,30853250,"Efficacy and safety of intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis (CHOICE): a single-centre, open-label, randomised, controlled, non-inferiority trial.","BACKGROUND Outpatient parenteral antimicrobial therapy in children is common despite no evidence of its efficacy or safety from clinical trials. We aimed to compare the efficacy and safety of intravenous antibiotic therapy at home with that of standard treatment in hospital for children with moderate to severe cellulitis. METHODS The Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial was a randomised, controlled, non-inferiority trial in children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis. Participants were randomly assigned to receive either intravenous ceftriaxone (50 mg/kg once daily) at home or intravenous flucloxacillin (50 mg/kg every 6 h) in hospital with web-based randomisation, stratified by age and periorbital cellulitis. The primary outcome was treatment failure, which was defined as no clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics within 48 h of the first dose. Secondary outcomes included adverse events and acquisition of antibiotic-resistant bacteria. Outcomes were assessed in all randomised participants with outcome data (intention-to-treat population) and in all individuals who received treatment as allocated and did not have any major protocol violations (per-protocol population). For home treatment to be non-inferior to hospital treatment, the difference between groups in the proportion of children with treatment failure in the intention-to-treat population had to be less than 15%. This trial is registered with ClinicalTrials.gov, number NCT02334124. FINDINGS Between Jan 9, 2015, and June 15, 2017, we screened 1135 children for eligibility, of whom 190 were randomly assigned to receive ceftriaxone at home (n=95) or flucloxacillin in hospital (n=95). The intention-to-treat analysis comprised 188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded. Treatment failure occurred in two (2%) children in the home group and in seven (7%) children in the hospital group (risk difference -5·2%, 95% CI -11·3 to 0·8, p=0·088). In the per-protocol analysis, treatment failure occurred in one (1%) of 89 children in the home group and in seven (8%) of 91 children in the hospital group (-6·5%, -12·4 to -0·7). Fewer children treated at home than in hospital had an adverse event (two [2%] vs ten [11%]; p=0·048). There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months. INTERPRETATION Home treatment with intravenous ceftriaxone is not inferior to treatment in hospital with intravenous flucloxacillin for children with cellulitis. The standard of care for the intravenous treatment of uncomplicated cellulitis in children should be home or outpatient care when feasible. FUNDING The Royal Children's Hospital Foundation and Murdoch Children's Research Institute.",2019,"There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months. ","['188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded', 'Between Jan 9, 2015, and June 15, 2017', ""children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis"", 'hospital for children with cellulitis (CHOICE', '1135 children for eligibility, of whom 190', 'The Cellulitis at Home or Inpatient in Children from the Emergency Department', 'hospital for children with moderate to severe cellulitis', 'children with cellulitis']","['flucloxacillin', 'intravenous ceftriaxone', 'ceftriaxone at home (n=95) or flucloxacillin', 'intravenous antibiotic therapy', 'ceftriaxone']","['Treatment failure', 'clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics', 'adverse events and acquisition of antibiotic-resistant bacteria', 'treatment failure', 'Efficacy and safety', 'efficacy and safety', 'adverse event', 'rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0559680', 'cui_str': 'Intravenous antibiotic therapy (procedure)'}]","[{'cui': 'C0162643'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1444090', 'cui_str': 'Resistant bacteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0025643', 'cui_str': 'Penicillin, Dimethoxyphenyl'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}]",1135.0,0.282425,"There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months. ","[{'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Ibrahim', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Melbourne Children's Trials Centre, Melbourne, VIC, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': ""Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Microbiology Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Bryant', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Hospital-In-The-Home Department, The Royal Children's Hospital, Melbourne, VIC, Australia. Electronic address: penelope.bryant@rch.org.au.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30729-1'] 1160,30719351,Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial.,"Background Chronic Obstructive Pulmonary Disease (COPD) impairs the function of the diaphragm by placing it at a mechanical disadvantage, shortening its operating length and changing the mechanical linkage between its various parts. This makes the diaphragm's contraction less effective in raising and expanding the lower rib cage, thereby increasing the work of breathing and reducing the functional capacity. Aim of the Study To compare the effects of diaphragmatic stretch and manual diaphragm release technique on diaphragmatic excursion in patients with COPD. Materials and Methods This randomised crossover trial included 20 clinically stable patients with mild and moderate COPD classified according to the GOLD criteria. The patients were allocated to group A or group B by block randomization done by primary investigator. The information about the technique was concealed in a sealed opaque envelope and revealed to the patients only after allocation of groups. After taking the demographic data and baseline values of the outcome measures (diaphragm mobility by ultrasonography performed by an experienced radiologist and chest expansion by inch tape performed by the therapist), group A subjects underwent the diaphragmatic stretch technique and the group B subjects underwent the manual diaphragm release technique. Both the interventions were performed in 2 sets of 10 deep breaths with 1-minute interval between the sets. The two outcome variables were recorded immediately after the intervention. A wash-out period of 3 hours was maintained to neutralize the effect of given intervention. Later the patients of group A and group B were crossed over to the other group. Results In the diaphragmatic stretch technique, there was a statistically significant improvement in the diaphragmatic excursion before and after the treatment. On the right side, p=0.00 and p=0.003 in the midclavicular line and midaxillary line. On the left side, p=0.004 and p=0.312 in the midclavicular and midaxillary line. In manual diaphragm release technique, there was a statistically significant improvement before and after the treatment. On the right side, p=0.000 and p=0.000 in the midclavicular line and midaxillary line. On the left side, p=0.002 and p=0.000 in the midclavicular line and midaxillary line. There was no statistically significant difference in diaphragmatic excursion in the comparison of the postintervention values of both techniques. Conclusion The diaphragmatic stretch technique and manual diaphragm release technique can be safely recommended for patients with clinically stable COPD to improve diaphragmatic excursion.",2019,"There was no statistically significant difference in diaphragmatic excursion in the comparison of the postintervention values of both techniques. ","['patients with COPD', '20 clinically stable patients with mild and moderate COPD classified according to the GOLD criteria', 'Chronic Obstructive Pulmonary Disease', 'patients with clinically stable COPD to improve diaphragmatic excursion', '\n\n\nChronic Obstructive Pulmonary Disease (COPD']","['diaphragmatic stretch and manual diaphragm release technique', 'diaphragmatic stretch technique', 'manual diaphragm release technique', 'Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique']","['diaphragmatic excursion', 'Diaphragmatic Excursion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion (observable entity)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion (observable entity)'}]",20.0,0.0198177,"There was no statistically significant difference in diaphragmatic excursion in the comparison of the postintervention values of both techniques. ","[{'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Manipal Academy of Higher Education, Bejai, Mangalore-575004, India.'}, {'ForeName': 'Gopala Krishna', 'Initials': 'GK', 'LastName': 'Alaparthi', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Manipal Academy of Higher Education, Bejai, Mangalore-575004, India.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Manipal Academy of Higher Education, Bejai, Mangalore-575004, India.'}, {'ForeName': 'Santhosh', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Department of Radiodiagnosis, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Mangalore-575004, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Department of Pulmonary Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore-575004, India.'}, {'ForeName': 'Vishak', 'Initials': 'V', 'LastName': 'Acharya', 'Affiliation': 'Department of Pulmonary Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore-575004, India.'}, {'ForeName': 'Preetam', 'Initials': 'P', 'LastName': 'Acharya', 'Affiliation': 'Department of Pulmonary Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore-575004, India.'}]",Pulmonary medicine,['10.1155/2019/6364376'] 1161,30859465,Mindfulness-based emotional eating awareness training: taking the emotional out of eating.,"PURPOSE Emotional eating is important to study and address because it predicts poor outcome in weight loss interventions. Interventions have only touched the surface in terms of addressing emotional eating. Mindfulness approaches can address emotional eating by modification of emotion regulation and appetitive traits. The current study involved development of an emotional eating-specific mindfulness intervention and assessment of its effect on appetitive traits associated with emotional eating. METHODS Participants (n = 14; age M = 29 years; 90% female) completed baseline and end-of-intervention self-report measures of emotional eating, food-cue reactivity, mindfulness, intuitive eating, emotional impulse regulation, stress, and a behavioural measure of inhibitory control. During the 6-week intervention, mindfulness meditation skills were taught weekly embedded in a psycho-educational curriculum about emotional eating. RESULTS Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05; d: 0.58-1.54). Changes in emotional eating approached significance (p = 0.075, d = 0.66). CONCLUSION The intervention purposefully did not focus on weight loss and recruited participants who had self-declared difficulties with emotional eating. The positive outcomes suggest that intervening with mindfulness training before weight loss is attempted has the potential to change psychological factors that underpin overeating and undermine weight loss efforts. The study provides proof of principle as a basis to design a randomized control trial to assess rigorously the effectiveness of the intervention as a precursor to a weight loss intervention. LEVEL OF EVIDENCE Level IV, uncontrolled trial.",2020,"RESULTS Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05;","['and recruited participants who had self-declared difficulties with emotional eating', 'Participants (n\u2009=\u200914; age M\u2009']","['emotional eating-specific mindfulness intervention', 'Mindfulness-based emotional eating awareness training']","['weight loss', 'emotional eating, food-cue reactivity, mindfulness, intuitive eating, emotional impulse regulation, stress, and a behavioural measure of inhibitory control', 'food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0219113,"RESULTS Paired t tests, controlled for type 1 error, revealed significant improvements in food-cue reactivity, intuitive eating, emotional impulse regulation, inhibitory control and stress (ps < 0.05;","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lattimore', 'Affiliation': 'School of Natural Sciences and Psychology, Liverpool John Moores University, Liverpool, L3 3AF, UK. p.j.lattimore@ljmu.ac.uk.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00667-y'] 1162,30925539,Cervical Spine Movement During Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope in Patients Undergoing Surgery for Cervical Spine Instability: A Randomized Control Trial.,"BACKGROUND Cervical spine movement during intubation with direct laryngoscopy can predispose to new-onset neurological deficits in patients with cervical spine instability. While fiberoptic-guided intubation (FGI) is mostly preferred in such patients, this is not always possible. Videolaryngoscopy results in less cervical spine movement than direct laryngoscopy and may be an alternative to FGI in patients with cervical spine instability. The objective of this study was to compare cervical spine movement during awake FGI with those during awake McGrath videolaryngoscope-guided intubation (VGI) in patients undergoing surgery for cervical spine instability. METHODS Forty-six adult patients with upper cervical spine instability scheduled for stabilization surgery were randomized to awake FGI or awake VGI. Cervical spine movement during intubation was assessed by changes in lateral fluoroscopic-measured angles (α and β at C1/C2 and C3 levels, respectively) at 3 time points: T1, preintubation; T2, during intubation; T3, postintubation. Motor power was assessed before and after intubation. RESULTS Patient demographics and airway characteristics were similar between the 2 groups. Cervical spine motion (in degrees) during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960). No patient developed new-onset motor deficits following intubation in either group. CONCLUSIONS Compared with FGI, VGI results in a greater degree of cervical spine movement at C1/C2 but not at C3.",2020,"during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960).","['Forty-six adult patients with upper cervical spine instability scheduled for stabilization surgery', 'Patients Undergoing Surgery for Cervical Spine Instability', 'patients undergoing surgery for cervical spine instability', 'patients with cervical spine instability']","['Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope', 'Videolaryngoscopy', 'direct laryngoscopy', 'awake FGI with those during awake McGrath videolaryngoscope-guided intubation (VGI', 'fiberoptic-guided intubation (FGI', 'awake FGI or awake VGI']","['Cervical Spine Movement', 'Motor power', 'Cervical spine movement', 'Cervical spine motion (in degrees', 'new-onset motor deficits', 'cervical spine movement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0410652', 'cui_str': 'Cervical spine instability (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]",46.0,0.205591,"during intubation was significantly greater with VGI than FGI at C1/C2 (T3-T1, -8.02±8.11 vs. -1.47±3.31; P<0.001) but not at C3 (T3-T1, -2.17±5.16 vs. -1.85±3.29; P=0.960).","[{'ForeName': 'Kaustuv', 'Initials': 'K', 'LastName': 'Dutta', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Kamath', 'Initials': 'K', 'LastName': 'Sriganesh', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Dhritiman', 'Initials': 'D', 'LastName': 'Chakrabarti', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}, {'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Pruthi', 'Affiliation': 'Neurosurgery, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India.'}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Reddy', 'Affiliation': 'Departments of Neuroanaesthesia and Neurocritical Care.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000595'] 1163,32407242,Exogenous ketosis impacts neither performance nor muscle glycogen breakdown in prolonged endurance exercise.,"Available evidence indicates that ketone bodies inhibit glycolysis in contracting muscles. Therefore, we investigated whether acute exogenous ketosis by oral ketone ester (KE) intake early in a simulated cycling race can induce transient glycogen sparing by glycolytic inhibition, thereby increasing glycogen availability in the final phase of the event. In a randomized crossover design, 12 highly trained male cyclists completed a simulated cycling race (RACE), which consisted of 3-h intermittent cycling (IMT 180' ), a 15-min time trial (TT 15' ), and a maximal sprint (SPRINT). During RACE, subjects received 60 g carbohydrates/h combined with three boluses (25, 20, and 20 g) ( R )-3-hydroxybutyl ( R )-3-hydroxybutyrate (KE) or a control drink (CON) at 60 and 20 min before and at 30 min during RACE. KE intake transiently increased blood d-β-hydroxybutyrate to ~3 mM (range: 2.6-5.2 mM) during the first half of RACE ( P < 0.001 vs. CON). Blood pH concomitantly decreased from approximately 7.42 to 7.36 (range: 7.29-7.40), whereas bicarbonate dropped from 26.0 to 21.6 mM (range: 20.1-23.7; both P < 0.001 vs. CON) . Net muscle glycogen breakdown during IMT 180' [KE: -78 ± 30 (SD); CON: -60 ± 22 mmol/kg wet wt; P = 0.08] and TT 15' (KE: -9 ± 18; CON: -18 ± 18 mmol/kg wet wt; P = 0.35) was similar between KE and CON. Accordingly, mean power output during TT 15' (KE: 273 ± 38; CON: 272 ± 37 W; P = 0.83) and time-to-exhaustion in the SPRINT (KE: 59 ± 16; CON: 58 ± 17 s; P = 0.66) were similar between conditions. In conclusion, KE intake during a simulated cycling race does not cause glycogen sparing, nor does it affect all-out performance in the final stage of a simulated race. NEW & NOTEWORTHY Exogenous ketosis produced by oral ketone ester ingestion during the early phase of prolonged endurance exercise and against the background of adequate carbohydrate intake neither causes muscle glycogen sparing nor improves performance in the final stage of the event. However, such exogenous ketosis may decrease buffering capacity in the approach of the final episode of the event. Furthermore, ketone ester intake during exercise may reduce appetite immediately after exercise.",2020,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15' (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.",['12 highly-trained male cyclists completed a simulated cycling race (RACE'],"[""IMT 180' (KE: -78±30 (SD"", 'R)-3-hydroxybutyl (R)-3-hydroxybutyrate (KE) or a control drink (CON', 'oral ketone ester (KE', 'maximal sprint (SPRINT']","['time-to-exhaustion', 'Blood pH', 'Net muscle glycogen breakdown']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C3529323', 'cui_str': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}]",,0.132524,"CON: -60±22 mmol/kg ww, p=0.08) and TT 15' (KE: -9±18; CON: -18±18 mmol/kg ww, p=0.35) was similar between KE and CON.","[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00092.2020'] 1164,30898339,Plasma copeptin levels predict disease progression and tolvaptan efficacy in autosomal dominant polycystic kidney disease.,"In the TEMPO 3:4 Trial, treatment with tolvaptan, a vasopressin V2 receptor antagonist, slowed the increase in total kidney volume and decline in estimated glomerular filtration rate (eGFR) in autosomal dominant polycystic kidney disease (ADPKD). We investigated whether plasma copeptin levels, a marker of plasma vasopressin, are associated with disease progression, and whether pre-treatment copeptin and treatment-induced change in copeptin are associated with tolvaptan treatment efficacy. This post hoc analysis included 1,280 TEMPO 3:4 participants (aged 18-50 years, estimated creatinine clearance ≥60 ml/min and total kidney volume ≥750 mL) who had plasma samples available at baseline for measurement of copeptin using an automated immunofluorescence assay. In placebo-treated subjects, baseline copeptin predicted kidney growth and eGFR decline over 3 years. These associations were independent of sex, age, and baseline eGFR, but were no longer statistically significant after additional adjustment for baseline total kidney volume. In tolvaptan-treated subjects, copeptin increased from baseline to week 3 (6.3 pmol/L versus 21.9 pmol/L, respectively). In tolvaptan-treated subjects with higher baseline copeptin levels, a larger treatment effect was noted with respect to kidney growth rate and eGFR decline. Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years. Copeptin holds promise as a biomarker to predict outcome and tolvaptan treatment efficacy in ADPKD.",2019,"Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years.","['autosomal dominant polycystic kidney disease', '1,280 TEMPO 3:4 participants (aged 18-50 years, estimated creatinine clearance\xa0≥60 ml/min and total kidney volume\xa0≥750 mL) who had plasma samples available at baseline for measurement of copeptin using an automated immunofluorescence assay']","['tolvaptan', 'placebo']","['kidney growth rate and eGFR decline', 'kidney growth and eGFR decline', 'plasma copeptin levels', 'copeptin', 'total kidney volume and decline in estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0056279', 'cui_str': 'C-terminal provasopressin'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0056279', 'cui_str': 'C-terminal provasopressin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3811844'}]",,0.0346573,"Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years.","[{'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands. Electronic address: r.t.gansevoort@umcg.nl.'}, {'ForeName': 'Maatje D A', 'Initials': 'MDA', 'LastName': 'van Gastel', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Section of Nephrology, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jaime D', 'Initials': 'JD', 'LastName': 'Blais', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higashihara', 'Affiliation': 'Department of ADPKD Research, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Department of Medicine, Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Stade', 'Affiliation': 'BRAHMS GmbH, Hennigsdorf, Germany.'}, {'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Devuyst', 'Affiliation': 'Institute of Physiology, University of Zurich, Zurich, Switzerland; and Division of Nephrology, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2018.11.044'] 1165,30882479,Effect of Documenting Prognosis on the Information Provided to ICU Proxies: A Randomized Trial.,"OBJECTIVES The Critical Care Choosing Wisely Task Force recommends that intensivists offer patients at high risk for death or severe functional impairment the option of pursuing care focused on comfort. We tested the a priori hypothesis that intensivists who are prompted to document patient prognosis are more likely to disclose prognosis and offer comfort-focused care. DESIGN Randomized controlled trial (clinicaltrials.gov: NCT02721810). SETTING High-fidelity Simulation Center in Baltimore, MD. PARTICIPANTS One hundred sixteen intensivists from 17 states. INTERVENTION All intensivists reviewed a paper-based medical record for a hypothetical patient on ICU day 3 and answered four survey questions about the patient's medical management. Intensivists randomized to the intervention group answered three additional questions about patient prognosis. Thereafter, each intensivist participated in a standardized, video-recorded, simulated family meeting with an actor performing a standardized portrayal of the patient's daughter. MEASUREMENTS AND MAIN RESULTS Two blinded intensivists reviewed deidentified written transcripts of all simulated family meetings. The primary outcome was the blinded reviewers' assessment that the intensivist had presented the option of care focused entirely on comfort. Secondary outcomes included disclosing risk of death. All outcomes were planned prior to data collection. Among the 63 intensivists randomized to the intervention, 50 (79%) expected the patient to die during the hospitalization and 58 (92%) expected the patient to have new functional impairments preventing independent living. Intensivists in the intervention versus control group were no more likely to offer the option of care focused on comfort (13% vs 13%; 95% CI, -13% to 12%; p = 1.0) but were more likely to inform the daughter that her father was sick enough to die (68% vs 43%; 95% CI, 5-44%; p = 0.01). CONCLUSIONS Documenting prognosis may help intensivists disclose prognosis to ICU proxies, but in isolation, it is unlikely to change the treatment options offered during initial family meetings.",2019,"Intensivists in the intervention versus control group were no more likely to offer the option of care focused on comfort (13% vs 13%; 95% CI, -13% to 12%; p = 1.0) but were more likely to inform the daughter that her father was sick enough to die (68% vs 43%; 95% CI, 5-44%; p = 0.01). ","['High-fidelity Simulation Center in Baltimore, MD', 'One hundred sixteen intensivists from 17 states']",['ICU Proxies'],"['option of care focused on comfort', 'disclosing risk of death']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",116.0,0.1307,"Intensivists in the intervention versus control group were no more likely to offer the option of care focused on comfort (13% vs 13%; 95% CI, -13% to 12%; p = 1.0) but were more likely to inform the daughter that her father was sick enough to die (68% vs 43%; 95% CI, 5-44%; p = 0.01). ","[{'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Program on Ethics and Decision Making, The Clinical Research, Investigation, and System Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Dale M', 'Initials': 'DM', 'LastName': 'Needham', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD.'}]",Critical care medicine,['10.1097/CCM.0000000000003731'] 1166,30820517,Effect of Creatine Supplementation Dosing Strategies on Aging Muscle Performance.,"OBJECTIVE This study compared the effects of different creatine supplementation dosages, independent of resistance training, on aging muscle performance and functionality. DESIGN AND PARTICIPANTS Using a double-blind, repeated measures design, participants were randomized to one of three groups: Creatine-High (CR-H; n=11; 0.3 g/kg/day of creatine + 0.1 g/kg/day of maltodextrin), Creatine-Moderate (CR-M: n=11; 0.1 g/kg/day of creatine + 0.3 g/kg/day of maltodextrin) or Placebo (PLA; n=11; 0.4 g/kg/day of maltodextrin) for 10 consecutive days. MEASUREMENTS The primary dependent variables measured at baseline and after supplementation included muscle strength (1-repetition maximum leg press, chest press, hand-grip), muscle endurance (leg press and chest press; maximal number of repetitions performed for 1 set at 80% and 70% baseline 1-repetition maximum respectively), and physical performance (dynamic balance). RESULTS There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0. 001; Chest press: CR-H pre 15.6 ± 2.7 reps, post 18.9 ± 2.7 reps; CR-M pre 18.0 ± 5.0 reps, post 19.9 ± 7.1 reps; PLA pre 20.5 ± 6.2 reps, post 21.6 ± 5.5 reps, p = 0. 001), with no other differences. CONCLUSION Short-term creatine supplementation, independent of dosage and resistance training, has no effect on aging muscle performance.",2019,"There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0.",[],"['Creatine-High (CR-H; n=11; 0.3 g/kg/day of creatine + 0.1 g/kg/day of maltodextrin), Creatine-Moderate', 'Creatine Supplementation', 'creatine + 0.3 g/kg/day of maltodextrin) or Placebo', 'maltodextrin']","['Aging Muscle Performance', 'time for muscle strength', 'physical performance (dynamic balance', 'muscle strength (1-repetition maximum leg press, chest press, hand-grip), muscle endurance (leg press and chest press; maximal number of repetitions performed for 1 set']",[],"[{'cui': 'C0860942', 'cui_str': 'Creatine increased'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2607857'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",,0.217584,"There was a significant increase over time for muscle strength (Leg press: CR-H pre 161.5 ± 55.1 kg, post 169.2 ± 59.2 kg; CR-M pre 145.2 ± 47.7 kg, post 151.7 ± 45.0 kg; PLA pre 163.7 ± 51.5 kg, post 178.2 ± 65.6 kg, p = 0.001; Chest press: CR-H pre 57.0 ± 26.2 kg, post 58.8 ± 28.0 kg; CR-M pre 54.5 ± 27.9 kg, post 56.8 ± 30.1 kg; PLA pre 55.1 ± 26.9 kg, post 58.5 ± 30.1 kg, p = 0.001) and endurance (Leg press: CR-H pre 17.1 ± 6.0 reps, post 21.0 ± 7.2 reps; CR-M pre 24.1 ± 11.6 reps, post 29.1 ± 17.0 reps; PLA pre 23.8 ± 9.7 reps, post 29.5 ± 11.9 reps, p = 0.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chami', 'Affiliation': 'Darren G. Candow, PhD, Professor and Associate Dean-Graduate Studies and Research, Faculty of Kinesiology and Health Studies, 3737 Wascana Parkway, University of Regina, Regina SK Canada, S4S 0A2, KHS.GSR-AssocDean@uregina.ca.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-018-1148-8'] 1167,30841745,Caregivers of older adults with dementia and multiple chronic conditions: Exploring their experiences with significant changes.,"Family caregiving is considered a social transition as changes in the health of the care recipient create a process of transition for the caregiver when they are more vulnerable to threats to their own health. Family and friend caregivers take on many responsibilities and experience high levels of burden when caring for community-dwelling older adults living with dementia and multiple chronic conditions. However, little is known about the changes they experience in their caring roles or how they cope with these changes. This qualitative descriptive study was part of a larger mixed methods randomized controlled trial evaluating a web-based caregiver support toolkit. Multiple semi-structured phone interviews were conducted with caregivers of older adults with dementia and multiple chronic conditions. Content analysis was used to generate thematic descriptions. Six themes were generated and grouped into two categories. Significant changes experienced by caregivers are described by the following themes: 'everything falls on you - all of the responsibilities,' 'too many feelings' and 'no time for me.' The themes describing how caregivers coped with these changes include: seeking support, self-caring, and adapting their caregiving approach. Study results indicate that caregivers of older adults with dementia and multiple chronic conditions experienced many changes in their caregiving journey resulting in increasing complexity as they tended to the care recipients' declining health and well-being. These caregivers used several creative strategies to cope with these changes. Health care providers should consider both the caregiver and care recipient as clients in the circle of care, and facilitate their linkage with health and community support services to help address the increasing complexity of care needs.",2019,"Significant changes experienced by caregivers are described by the following themes: 'everything falls on you - all of the responsibilities,' 'too many feelings' and 'no time for me.'","['community-dwelling older adults living with dementia and multiple chronic conditions', 'older adults with dementia and multiple chronic conditions', 'caregivers of older adults with dementia and multiple chronic conditions', 'Caregivers of older adults with dementia and multiple chronic conditions']","['Multiple semi-structured phone interviews', 'web-based caregiver support toolkit']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support (regime/therapy)'}]",[],6.0,0.026332,"Significant changes experienced by caregivers are described by the following themes: 'everything falls on you - all of the responsibilities,' 'too many feelings' and 'no time for me.'","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Northwood', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Duggleby', 'Affiliation': 'Innovation in Seniors Care Research Unit, Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'McAiney', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Schlegel-UW Research Institute for Aging, Waterloo Canada.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Chambers', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Peacock', 'Affiliation': 'College of Nursing, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fisher', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Markle-Reid', 'Affiliation': 'Aging, Community and Health Research Unit, School of Nursing, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Swindle', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'School of Geography & Earth Sciences, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Jean Ac', 'Initials': 'JA', 'LastName': 'Triscott', 'Affiliation': 'Division of Care of the Elderly, Department of Family Medicine, University of Alberta, Edmonton, Canada.'}]","Dementia (London, England)",['10.1177/1471301219834423'] 1168,30833160,Immunogenicity and safety of measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine in infants aged 8 months in China: a non-inferiority randomised controlled trial.,"BACKGROUND In China, measles-rubella vaccine and live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) are recommended for simultaneous administration at 8 months of age, which is the youngest recommended age for these vaccines worldwide. We aimed to assess the effect of the co-administration of these vaccines at 8 months of age on the immunogenicity of measles-rubella vaccine. METHODS We did a multicentre, open-label, non-inferiority, two-group randomised controlled trial in eight counties or districts in China. We recruited healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site. Enrolled infants were randomly assigned (1:1) to receive either measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group). The primary outcome was the proportion of infants with IgG antibody seroconversion for measles 6 weeks after vaccination, and a secondary outcome was the proportion of infants with IgG antibody seroconversion for rubella 6 weeks after vaccination. Analyses included all infants who completed the study. We used a 5% margin to establish non-inferiority. This trial was registered at ClinicalTrials.gov (NCT02643433). FINDINGS 1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016. Of 1093 (93%) enrolled infants, 545 were randomly assigned to the measles-rubella plus LJEV group and 548 to the measles-rubella group. Of the infants assigned to each group, 507 in the measles-rubella plus LJEV group and 506 in the measles-rubella group completed the study. Before vaccination, six (1%) of 507 infants in the measles-rubella plus LJEV group and one (<1%) of 506 in the measles-rubella group were seropositive for measles; eight (2%) infants in the measles-rubella plus LJEV group and two (<1%) in the measles-rubella group were seropositive for rubella. 6 weeks after vaccination, measles seroconversion in the measles-rubella plus LJEV group (496 [98%] of 507) was non-inferior to that in the measles-rubella group (499 [99%] of 506; difference -0·8% [90% CI -2·6 to 1·1]) and rubella seroconversion in the measles-rubella plus LJEV group (478 [94%] of 507) was non-inferior to that in the measles-rubella group (473 [94%] of 506 infants; difference 0·8% [90% CI -1·8 to 3·4]). There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting). Fever was the most common adverse event (97 [19%] of 507 infants in the measles-rubella plus LJEV group; 108 [21%] of 506 infants in the measles-rubella group). INTERPRETATION The evidence of similar seroconversion and safety with co-administered LJEV and measles-rubella vaccines supports the co-administration of these vaccines to infants aged 8 months. These results will be important for measles and rubella elimination and the expansion of Japanese encephalitis vaccination in countries where it is endemic. FUNDING US Centers for Disease Control and Prevention, US Department of Health and Human Services; China-US Collaborative Program on Emerging and Re-emerging Infectious Diseases.",2019,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","['Of 1093 (93%) enrolled infants, 545', '1173 infants were assessed for eligibility between Aug 13, 2015, and June 10, 2016', 'healthy infants aged 8 months who had received all scheduled vaccinations according to the national immunisation recommendations and who lived in the county of the study site', 'eight counties or districts in China', 'group and 506 in the measles-rubella group completed the study', 'group and 548 to the measles-rubella group', 'infants aged 8 months in China']","['measles-rubella vaccine and LJEV simultaneously (measles-rubella plus LJEV group) or measles-rubella vaccine alone (measles-rubella group', 'LJEV', 'measles-rubella plus LJEV', 'measles-rubella vaccine co-administered with attenuated Japanese encephalitis SA 14-14-2 vaccine']","['measles seroconversion', 'proportion of infants with IgG antibody seroconversion', 'prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting', 'rubella seroconversion', 'serious adverse events', 'Fever', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517809', 'cui_str': 'Five hundred and forty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0035923', 'cui_str': 'rubella, live attenuated'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0014057', 'cui_str': 'Viral Encephalitis, Japanese B'}, {'cui': 'C4277085', 'cui_str': 'SA-14-14-2 vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1173.0,0.180644,"There were no serious adverse events in either group and no evidence of a difference between the two groups in the prevalence of any local adverse event (redness, rashes, and pain) or systemic adverse event (fever, allergy, respiratory infections, diarrhoea, and vomiting).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Chu', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wannemuehler', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunization Program Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.'}, {'ForeName': 'Fubin', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Immunization Program Department, Ningbo Prefectural Center for Disease Control and Prevention, Ningbo, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China; Immunization Program Department, Lishui Prefectural Center for Disease Control and Prevention, Lishui, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Zuo', 'Affiliation': 'Immunization Program Department, Baoding Prefectural Center for Disease Control and Prevention, Baoding, China.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Rodewald', 'Affiliation': 'Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Qiyou', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunization Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: anzj@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(18)30650-9'] 1169,31743282,"Calcitonin Gene-Related Peptide in Blind, Painful Eyes.","PURPOSE To determine if calcitonin gene-related peptide (CGRP) is overexpressed in blind, painful eyes. METHODS This was a retrospective cross-sectional randomized control study conducted at a tertiary level hospital. Eight specimens of eyes enucleated by a single surgeon were included in the study. The control group patients underwent exenteration for cutaneous malignancy without intraocular involvement, while the case group was enucleated for management of blind, painful eye. Each eye was stained using immunohistochemistry for the expression of CGRP. Expression of CGRP was examined by counting the number of cells staining positive for CGRP in 5 consecutive ×40 fields in the choroid, iris, and cornea of each specimen. RESULTS The mean number of cells staining positively for CGRP in the choroid of blind, painful eye group was 45.5 (26.3) versus 5.5 (7.7) in nonpainful enucleated eyes. This difference was found to be statistically significant (p = 0.016). Comparison of iris and cornea did not reach statistical significance. Expression of CGRP was compared using a paired t test. CONCLUSIONS This study demonstrates that CGRP is overexpressed in the choroid of enucleated blind, painful eyes. Modulation of this protein may represent a meaningful, nonsurgical therapeutic strategy to addressing the blind, painful eye.",2020,Comparison of iris and cornea did not reach statistical significance.,['Eight specimens of eyes enucleated by a single surgeon were included in the study'],"['Calcitonin Gene-Related Peptide', 'CGRP', 'calcitonin gene-related peptide (CGRP']","['Expression of CGRP', 'mean number of cells staining positively for CGRP']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0487602', 'cui_str': 'Staining'}]",,0.110265,Comparison of iris and cornea did not reach statistical significance.,"[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Godbout', 'Affiliation': 'Department of Ophthalmology, Lions Eye Institute, Albany Medical College.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Lau', 'Affiliation': 'Department of Ophthalmology, Lions Eye Institute, Albany Medical College.'}, {'ForeName': 'Alejandro P', 'Initials': 'AP', 'LastName': 'Adam', 'Affiliation': 'Department of Ophthalmology, Lions Eye Institute, Albany Medical College.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Wladis', 'Affiliation': ''}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001512'] 1170,30837190,Endoscopic cartilage tympanoplasty: full thickness and partial thickness tragal graft.,"INTRODUCTION Cartilage is the grafting material of choice for certain disorders of the middle ear. The indications for its routine use remain controversial due to the possible detrimental effect on post-operative hearing. OBJECTIVE The present study was carried out to report a personal experience with ""tragal cartilage shield"" tympanoplasty to compare the results, in terms of graft uptake and hearing improvement, of endoscopic cartilage shield technique using either partial thickness or full thickness tragal cartilage for type 1 tympanoplasty and to highlight the tips for single-handed endoscopic ear surgery. METHODS Fifty patients with safe chronic suppurative otitis media, assisted at out-patient department from February 2014 to September 2015 were selected. They were randomly allocated into two groups, 25 patients were included in group A where a full thickness tragal cartilage was used and 25 patients included in group B where a partial thickness tragal cartilage was used. Audiometry was performed 2 months after the surgery in all cases and the patients were followed for one year. RESULTS Out of the total of 50 patients 39 (78%) had a successful graft take up, amongst these 22 belonged to group A and 17 belonged to the group B. The hearing improvement was similar in both groups. CONCLUSION This study reveals that endoscopic tragal cartilage shield tympanoplasty is a reliable technique; with a high degree of graft take and good hearing results, irrespective of the thickness. Furthermore, the tragal cartilage is easily accessible, adaptable, resistant to resorption and single-handed endoscopic ear surgery is minimally invasive, sutureless and provides a panoramic view of the middle ear.",2020,"The hearing improvement in both the groups was very similar. ","['report personal experience with ""tragal cartilage shield"" tympanoplasty', 'Fifty patients with safe chronic suppurative otitis media, presenting in our out-patient department from February 2014 to September 2015 were selected']",['Endoscopic cartilage tympanoplasty'],"['successful graft take', 'hearing improvement']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]",50.0,0.0221733,"The hearing improvement in both the groups was very similar. ","[{'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Parelkar', 'Affiliation': 'Grant Government Medical College & Sir J.J. Hospitals, Mumbai, India. Electronic address: kartikparelkar@gmail.com.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Thorawade', 'Affiliation': 'Grant Government Medical College & Sir J.J. Hospitals, Mumbai, India.'}, {'ForeName': 'Hetal', 'Initials': 'H', 'LastName': 'Marfatia', 'Affiliation': 'K.E.M. Hospital, Department of ENT, Parel, Mumbai, India.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Shere', 'Affiliation': 'Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane, India.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2018.12.006'] 1171,30707478,Contralateral segmental transcutaneous electrical nerve stimulation inhibits nociceptive flexion reflex in healthy participants.,"BACKGROUND Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment to relieve pain. Contralateral TENS (i.e. TENS administered to the contralateral side of a painful body part) is beneficial when TENS cannot be directly applied to pain site, such as in cases of trauma. Although TENS produces segmental analgesia in an ipsilateral limb, it has been unclear whether TENS produces higher analgesic effects in the contralateral segmental area. The aim of the present study was to investigate the analgesic effects of TENS in contralateral segmental or extra-segmental areas on physiological and subjective pain outcomes, using a nociceptive flexion reflex (NFR) method. METHODS We randomly allocated 60 healthy participants to three groups: contralateral segmental TENS (CS-TENS); contralateral extra-segmental TENS (CE-TENS); and contralateral placebo TENS (CP-TENS). CS-TENS was applied to right superficial sural nerve and CE-TENS was applied to the right superficial femoral nerve, each for 30 minutes. The magnitude of the NFR elicited by electrical stimulation of the left sural nerve was measured at baseline and at three subsequent 10-minute intervals. Subjective pain intensity was measured simultaneously with a visual analogue scale (VAS). RESULTS At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021). There were no significant differences in VAS scores among the groups at any time point. CONCLUSIONS Our findings suggest that CS-TENS inhibited NFR. Although there was no significant between-group difference in subjective pain intensity, factors such as a placebo effect probably impacted it. SIGNIFICANCE Our findings provide support for the contralateral approach at stimulation sites when TENS cannot be directly administered to a pain site (e.g. due to disease or trauma).",2019,"At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021).","['60 healthy participants to three groups', 'healthy participants']","['Contralateral TENS (i.e. TENS', 'CP-TENS', 'contralateral segmental TENS (CS-TENS); contralateral extra-segmental TENS (CE-TENS); and contralateral placebo TENS (CP-TENS', 'TENS', 'Contralateral segmental transcutaneous electrical nerve stimulation inhibits nociceptive flexion reflex', 'Transcutaneous electrical nerve stimulation (TENS', 'nociceptive flexion reflex (NFR) method']","['NFR magnitude', 'Subjective pain intensity', 'subjective pain intensity', 'VAS scores', 'visual analogue scale (VAS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1264664', 'cui_str': 'Number fraction'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.0290577,"At 30 min, the NFR magnitude of CS-TENS group was significantly lower than that of the CP-TENS group (p = 0.021).","[{'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Rehabilitation, Gakkentoshi Hospital, Kyoto, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Shomoto', 'Affiliation': 'Graduate School of Health Science, Kio University, Nara, Japan.'}]","European journal of pain (London, England)",['10.1002/ejp.1373'] 1172,30819464,Evaluating implementation supports delivered within problem-solving consultation.,"Teachers participating in problem-solving consultation often struggle to maintain adequate treatment fidelity, which is necessary to improve student outcomes. Low levels of treatment fidelity may result from implementation barriers, such as intervention compatibility, implementer skill, and implementer motivation. This study involves the evaluation of five implementation supports designed to address implementation barriers (i.e., Implementation Planning, Role Play, Participant Modeling, Raising Awareness, Motivational Consulting) within problem-solving consultation. Across 14 randomized individual single-case AB intervention designs, we evaluated the impact of these implementation supports on teacher treatment fidelity of classroom management plans and class-wide academic engagement and disruptive behavior. Visual analysis, descriptive statistics, and randomization test analyses suggest that these implementation supports have the potential to be broadly effective in improving teachers' fidelity and student outcomes. Teachers required a different number of supports to increase fidelity levels and rated the implementation supports positively. Implications of the study's findings are described.",2019,"Across 14 randomized individual single-case AB intervention designs, we evaluated the impact of these implementation supports on teacher treatment fidelity of classroom management plans and class-wide academic engagement and disruptive behavior.",['Teachers participating in problem-solving consultation often struggle'],[],[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",[],[],,0.02111,"Across 14 randomized individual single-case AB intervention designs, we evaluated the impact of these implementation supports on teacher treatment fidelity of classroom management plans and class-wide academic engagement and disruptive behavior.","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Collier-Meek', 'Affiliation': 'University of Massachusetts Boston, United States of America. Electronic address: mel.colliermeek@umb.edu.'}, {'ForeName': 'Lisa M H', 'Initials': 'LMH', 'LastName': 'Sanetti', 'Affiliation': 'University of Connecticut, United States of America.'}, {'ForeName': 'Joel R', 'Initials': 'JR', 'LastName': 'Levin', 'Affiliation': 'University of Arizona, United States of America.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kratochwill', 'Affiliation': 'University of Wisconsin Madison, United States of America.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Boyle', 'Affiliation': 'University of Connecticut, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2018.12.002'] 1173,31705740,Transient perturbation of the left temporal cortex evokes plasticity-related reconfiguration of the lexical network.,"While much progress has been made in how brain organization supports language function, the language network's ability to adapt to immediate disturbances by means of reorganization remains unclear. The aim of this study was to examine acute reorganizational changes in brain activity related to conceptual and lexical retrieval in unimpaired language production following transient disruption of the left middle temporal gyrus (MTG). In a randomized single-blind within-subject experiment, we recorded the electroencephalogram from 16 healthy participants during a context-driven picture-naming task. Prior to the task, the left MTG was perturbed with real continuous theta-burst stimulation (cTBS) or sham stimulation. During the task, participants read lead-in sentences creating a constraining (e.g., ""The farmer milks the"") or nonconstraining context (e.g., ""The farmer buys the""). The last word was shown as a picture that participants had to name (e.g., ""cow""). Replicating behavioral studies, participants were overall faster in naming pictures following a constraining relative to a nonconstraining context, but this effect did not differ between real and sham cTBS. In contrast, real cTBS increased overall error rates compared to sham cTBS. In line with previous studies, we observed a decrease in alpha-beta (8-24 Hz) oscillatory power for constraining relative to nonconstraining contexts over left temporal-parietal cortex after participants received sham cTBS. However, following real cTBS, this decrease extended toward left prefrontal regions associated with both domain-general and domain-specific control mechanisms. Our findings provide evidence that immediately after perturbing the left MTG, the lexical-semantic network is able to quickly reconfigure, also recruiting domain-general regions.",2020,"Replicating behavioral studies, participants were overall faster in naming pictures following a constraining relative to a nonconstraining context, but this effect did not differ between real and sham cTBS.",['16 healthy participants during a context-driven picture-naming task'],['real continuous theta-burst stimulation (cTBS) or sham stimulation'],"['overall error rates', 'alpha-beta']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",,0.0673539,"Replicating behavioral studies, participants were overall faster in naming pictures following a constraining relative to a nonconstraining context, but this effect did not differ between real and sham cTBS.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Klaus', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Dennis J L G', 'Initials': 'DJLG', 'LastName': 'Schutter', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'Piai', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University, Nijmegen, Netherlands.'}]",Human brain mapping,['10.1002/hbm.24860'] 1174,30826240,Efficacy and safety of a new selective laser device to create anterior capsulotomies in cataract patients.,"PURPOSE To compare the efficacy and safety of anterior capsulotomy creation with a new selective laser device (CAPSULaser) with those of manual capsulotomies. SETTING GEMINI Eye Clinic, Zlin, Czech Republic. DESIGN Prospective case series. METHODS Patients were placed in cohorts based on age and cataract grade and randomly allocated to have laser capsulotomy or manual continuous curvilinear capsulorhexis (CCC). The anterior capsule was stained with microfiltered trypan blue 0.4%. The anterior capsulotomy was created with the laser device focused on the anterior capsule through a custom patient interface lens. Intraoperative video analysis with the use of an intraocular ruler and postoperative examinations were used to assess safety and efficacy (accuracy of capsulotomy size, circularity, centration). RESULTS No intraoperative complications occurred in the laser group or the manual group. All capsulotomies in the laser group were free-floating with no tags or tears. The mean capsulotomy diameter was 5.03 mm overall (range 4.8 to 5.2 mm, laser group; 4.4 to 5.8 mm, manual group). In the laser group, all the capsulotomies were within 0.1 mm ± 0.1 (SD) of the target. The circularity accuracy was greater than 99.0% ± 1.0%; the mean centration of the capsulotomy in relation to the intraocular lens (IOL) was 0.1 ± 0.1 mm. All parameters were statistically significant (P < .01). The IOL-capsulotomy overlap was 360 degrees in all laser cases. CONCLUSIONS Selective laser capsulotomy using a new proprietary trypan blue formulation was safe and effective in cataract surgery. The sizing, circularity, and centration of the laser capsulotomy were more accurate than those of the manual CCC, resulting in consistent 360-degree IOL coverage.",2019,No intraoperative complications occurred in the laser group or the manual group.,"['Patients were placed in cohorts based on age and cataract grade', 'cataract patients', 'GEMINI Eye Clinic, Zlin, Czech Republic']","['anterior capsulotomy creation with a new selective laser device (CAPSULaser', 'Selective laser capsulotomy', 'laser capsulotomy or manual continuous curvilinear capsulorhexis (CCC', 'new selective laser device']","['mean capsulotomy diameter', 'intraoperative complications', 'safety and efficacy (accuracy of capsulotomy size, circularity, centration', 'circularity accuracy', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0525027', 'cui_str': 'Capsulorhexis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",,0.020671,No intraoperative complications occurred in the laser group or the manual group.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Stodulka', 'Affiliation': 'Charles University, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Packard', 'Affiliation': 'Arnott Eye Associates, London, United Kingdom. Electronic address: eyequack@vossnet.co.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mordaunt', 'Affiliation': 'EXCEL-LENS, Inc., Los Gatos, California, USA.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.12.012'] 1175,29956424,One MRI-compatible tDCS session attenuates ventromedial cortical perfusion when exposed to verbal criticism: The role of perceived criticism.,"Transcranial direct current stimulation (tDCS) is a potential treatment strategy for mood and anxiety disorders, but how this application may influence emotional processes, and whether this is related to individual characteristics, is not well understood. It has been proposed that perceived criticism (PC) may represent a vulnerability factor for the development of such mental illnesses. To decipher whether neural mechanisms of action of tDCS potentially differ depending on PC status (low vs. high), we evaluated mood and brain perfusion before and after applying MRI-compatible tDCS, and after participants were exposed to verbal criticism in the scanner. Experimental design 30 healthy nondepressed females were included in a sham-controlled crossover MRI-compatible tDCS study. Brain perfusion was measured by means of arterial spin labeling (ASL) before and after tDCS applied to the left dorsolateral prefrontal cortex (DLPFC), and after hearing criticism. Before the experiment, all participants provided a rating of PC in their closest environment. Principal observations at the behavioral level, criticism made participants angrier. This was unrelated to the active or sham stimulation. After being criticized, females scoring high on PC had significantly decreased brain perfusion in the pregenual anterior cingulate cortex (pgACC) and medioprefrontal cortex (mPFC), after active tDCS but not sham. The decrease in pgACC/mPFC perfusion points to a significant impact of tDCS in brain areas related to stress responses and self-referential processes, especially in females scoring high on PC, which has been shown to be related to vulnerability for mood and anxiety disorders.",2018,"After being criticized, females scoring high on PC had significantly decreased brain perfusion in the pregenual anterior cingulate cortex (pgACC) and medioprefrontal cortex (mPFC), after active tDCS but not sham.",['30 healthy nondepressed females'],"['Transcranial direct current stimulation (tDCS', 'MRI-compatible tDCS session']","['Brain perfusion', 'pregenual anterior cingulate cortex (pgACC) and medioprefrontal cortex (mPFC', 'brain perfusion']","[{'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}]",30.0,0.0237725,"After being criticized, females scoring high on PC had significantly decreased brain perfusion in the pregenual anterior cingulate cortex (pgACC) and medioprefrontal cortex (mPFC), after active tDCS but not sham.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Josefien', 'Initials': 'J', 'LastName': 'Dedoncker', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Remue', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Guo-Rong', 'Initials': 'GR', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Witte', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Poppa', 'Affiliation': 'Department of Psychology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Hooley', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}]",Human brain mapping,['10.1002/hbm.24285'] 1176,30829892,High-fidelity Training Model for Measurement of Dynamic Optic Nerve Sheath Diameter Using Transorbital Ultrasonography.,"BACKGROUND Transorbital ultrasonographic measurement of optic nerve sheath diameter (ONSD) is an important technique for bedside assessment of raised intracranial pressure (ICP). However, developing competency for this clinical skill requires practice scans on both normal subjects and patients with raised ICP. The aim of this study is to develop a high-fidelity training model capable of measuring dynamic changes in ONSD and to test the reliability and reproducibility of the model at different simulated ICP values. MATERIALS AND METHODS We designed and developed a high-fidelity training model for dynamic ONSD measurement using a hemispherical table tennis ball, mounted on a 3.0-mm pediatric microcuffed endotracheal tube (ETT). Two independent investigators then performed a randomized blinded study to assess the reliability and reproducibility of the model. A total of 30 ONSD measurements (10 measurements each for 3 ETT cuff volumes of 0.1, 0.2, and 0.3 mL, simulating an ONSD of a normal, borderline, and raised ICP, respectively) were performed by each investigator. Intraclass correlation coefficients and Bland-Altman plots were calculated to analyze the level of agreement between the investigators. RESULTS Our model was able to provide dynamic changes in ONSD secondary to ETT cuff volume changes. Small increments of 0.1 mL cuff volume changes produced immediate changes in ONSD that are similar to those observed in patients. The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0. to 0.4 mm). Intraclass correlation coefficient was 0.89, 0.89, and 0.90 for 0.1, 0.2, and 0.3 mL ETT cuff volumes, respectively. CONCLUSIONS We have developed a clinically relevant model capable of simulating changes in ONSD in patients with normal and raised ICP. This model could be a valuable training tool to gain scanning experience in optic nerve ultrasonography, and improve operators' technical abilities.",2020,"The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0.","['normal subjects and patients with raised ICP', 'patients with normal and raised ICP']","['hemispherical table tennis ball, mounted on a 3.0-mm pediatric microcuffed endotracheal tube (ETT', 'optic nerve sheath diameter (ONSD']","['Dynamic Optic Nerve Sheath Diameter', 'median interobserver difference in ONSD']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}]","[{'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0336994', 'cui_str': 'Tennis ball, device (physical object)'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0410696,"The median interobserver difference in ONSD was 0.3 mm (interquartile range, 0.","[{'ForeName': 'Zakir', 'Initials': 'Z', 'LastName': 'Hajat', 'Affiliation': 'Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dinsmore', 'Affiliation': ''}, {'ForeName': 'Lashmi', 'Initials': 'L', 'LastName': 'Venkatraghavan', 'Affiliation': ''}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000592'] 1177,30784555,"Comparison of prasugrel and clopidogrel in patients with non-cardioembolic ischaemic stroke: a phase 3, randomised, non-inferiority trial (PRASTRO-I).","BACKGROUND The effect of prasugrel in terms of the prevention of recurrence of ischaemic stroke is unknown. We investigated the non-inferiority of prasugrel to clopidogrel for prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes in Japanese patients with non-cardioembolic stroke. METHODS In this phase 3 randomised, double-blind, non-inferiority trial, patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan. Eligible patients were randomly assigned (1:1) to receive prasugrel (3·75 mg/day) or clopidogrel (75 mg/day) orally for 96-104 weeks. Randomisation was stratified according to stroke subtype. The randomisation schedule was generated by an independent statistician who created a computer-generated random number sequence. Patients, investigators, and the funder were masked to treatment allocation. The primary endpoint was combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population. The safety endpoint was incidence of bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding. The safety analysis was done in the population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug. The predefined non-inferiority margin was an upper 95% CI limit for the risk ratio (RR) of 1·35. The trial was registered with the Japan Pharmaceutical Information Center (JapicCTI-111582). FINDINGS Patients were recruited between Sept 1, 2011, and June 12, 2015. 3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years. 3753 patients were randomly assigned to treatment and, of these patients, 1885 in the prasugrel group and 1862 in the clopidogrel group were confirmed to have taken the trial drug at least once, and six patients withdrew from the trial before administration of the trial drug. Thus, a total of 3747 patients were included in the full analysis set. 73 (4%) of 1885 patients in the prasugrel group and 69 (4%) of 1862 patients in the clopidogrel group reached the primary endpoint (RR 1·05, 95% CI 0·76-1·44). The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42). INTERPRETATION The non-inferiority of prasugrel to clopidogrel for the prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes was not confirmed in Japanese patients with non-cardioembolic stroke. No safety concerns were identified. FUNDING Daiichi Sankyo.",2019,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42). ","['patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan', 'Japanese patients with non-cardioembolic stroke', '3753 patients', 'patients with non-cardioembolic ischaemic stroke', 'population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug', 'Patients were recruited between Sept 1, 2011, and June 12, 2015', '3747 patients were included in the full analysis set', 'Eligible patients', '3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years']","['prasugrel to clopidogrel', 'prasugrel', 'prasugrel and clopidogrel', 'clopidogrel']","['life-threatening bleeding', 'incidence of bleeding events', 'combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population', 'bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding', 'ischaemic stroke, myocardial infarction, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3747.0,0.475259,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42). ","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan. Electronic address: aogawa@iwate-med.ac.jp.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Neurology, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Tanahashi', 'Affiliation': 'Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nagata', 'Affiliation': 'Department of Neurosurgery, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30449-6'] 1178,20814963,Repetition suppression in occipitotemporal cortex despite negligible visual similarity: evidence for postperceptual processing?,"The reduced neural response in certain brain regions when a task-relevant stimulus is repeated (""repetition suppression"", RS) is often attributed to facilitation of the cognitive processes performed in those regions. Repetition of visual objects is associated with RS in the ventral and lateral occipital/temporal regions, and is typically attributed to facilitation of visual processes, ranging from the extraction of shape to the perceptual identification of objects. In two fMRI experiments using a semantic classification task, we found RS in a left lateral occipital/inferior temporal region to a picture of an object when the name of that object had previously been presented in a separate session. In other words, we found RS despite negligible visual similarity between the initial and repeated occurrences of an object identity. There was no evidence that this RS was driven by the learning of task-specific responses to an object identity (""S-R learning""). We consider several explanations of this occipitotemporal RS, such as phonological retrieval, semantic retrieval, and visual imagery. Although no explanation if fully satisfactory, it is proposed that such effects most plausibly relate to the extraction of task-relevant information relating to object size, either through the extraction of sensory-specific semantic information or through visual imagery processes. Our findings serve to emphasize the potential complexity of processing within traditionally visual regions, at least as measured by fMRI.",2011,"There was no evidence that this RS was driven by the learning of task-specific responses to an object identity (""S-R learning"").",[],[],['Repetition of visual objects'],[],[],"[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",,0.0579698,"There was no evidence that this RS was driven by the learning of task-specific responses to an object identity (""S-R learning"").","[{'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Horner', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, Cambridge, England, UK.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Henson', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21124'] 1179,30789807,Association Between Bat Vitamin D Receptor 3' Haplotypes and Vitamin D Levels at Baseline and a Lower Response After Increased Vitamin D Supplementation and Exposure to Sunlight.,"Objective: The aim of this study was to evaluate the relationship between vitamin D levels at baseline and after 12 weeks of supplementation/exposure to sunlight and VDR genotypes (BsmI, TaqI and ApaI) and haplotypes in a homogeneous population of postmenopausal women. Methods: We made a prospective study in which 151 women were randomized to two groups: One with 1000 mg of calcium and 800 IU vitamin D supplementation (102 women) and a placebo group with neither calcium or vitamin D supplementation (49 women). The follow-up was from May to September 2012.Vitamin D was determined by chemiluminescent immunoassay. Genotypes were determined using the Sequenomi Plexplatform and haplotypes using PHASE software. Results: Baseline (25 ± 10 ng/ml vs. 23 ± 9 ng/ml, p > 0.05) and 12-week (32 ± 8 ng/ml vs. 29 ± 10 ng/ml, p > 0.05) vitamin D levels were similar between the two groups. The genetic study was made in the total population. There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs. 21 ± 10 ng/ml, p = 0.038). The rate of nonresponders in this group was 15 % (p = 0.001), compared with 9 %, 2 % and 3 % in the other groups. Conclusions: The Bat haplotype was associated with lower baseline levels of vitamin D and a worse response to supplementation and, therefore, may be a risk factor for vitamin D deficiency.",2020,"There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs. 21 ± 10 ","['homogeneous population of postmenopausal women', '10', '49 women', '151 women']","['calcium and 800 IU vitamin D supplementation', 'supplementation/exposure to sunlight and VDR genotypes (BsmI, TaqI and ApaI) and haplotypes', 'placebo group with neither calcium or vitamin D supplementation']","['baseline and final levels of vitamin D', 'vitamin D levels', 'Vitamin D Levels', 'rate of nonresponders']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0066198', 'cui_str': 'methyl p-azidophenyl acetimidate'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",151.0,0.376441,"There were no differences in baseline and final levels of vitamin D in terms of genotypes and haplotypes, except for the Bat haplotype, whose baseline values were lower (25OHD: 21 ± 10 ng/ml vs. 21 ± 10 ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Pérez-Alonso', 'Affiliation': 'Faculty of Medicine, University of Valladolid, Spain.'}, {'ForeName': 'Laisa-Socorro', 'Initials': 'LS', 'LastName': 'Briongos', 'Affiliation': 'Department of Internal Medicine, University Hospital Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz-Mambrilla', 'Affiliation': 'Faculty of Medicine, University of Valladolid, Spain.'}, {'ForeName': 'Eladio A', 'Initials': 'EA', 'LastName': 'Velasco', 'Affiliation': 'Institute of Molecular and Genetic Biology, University of Valladolid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Olmos', 'Affiliation': 'Department of Internal Medicine, University Hospital Marques de Valdecilla, University of Cantabria, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Luis', 'Affiliation': 'Department of Endocrinology, University Hospital Valladolid, University of Valladolid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dueñas-Laita', 'Affiliation': 'Department of Clinical Pharmacology, University Hospital Río Hortega, University of Valladolid, Spain.'}, {'ForeName': 'José-Luis', 'Initials': 'JL', 'LastName': 'Pérez-Castrillón', 'Affiliation': 'Department of Internal Medicine, University Hospital Río Hortega, Valladolid, Spain.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000534'] 1180,30789808,No beneficial effects of resveratrol supplementation on atherogenic risk factors in patients with nonalcoholic fatty liver disease.,"Introduction: Cardiovascular disease (CVD) accounts as a major cause of mortality among patients with nonalcoholic fatty liver disease (NAFLD). Resveratrol, a natural polyphenol compound, is known for its antioxidant and antiatherogenic properties and is purported to be beneficial in decreasing CVD risk factors in NAFLD patients. Objectives : This study aimed to investigate the effects of resveratrol on atherogenic risk factors in patients with NAFLD. Methods : This randomized, double-blind, placebo-controlled clinical trial was performed on 50 patients with NAFLD aged 20-60 years. Subjects were randomly assigned to receive a daily dose of 600 mg resveratrol (n = 25) or placebo (n = 25) for 12 wk. Serum liver enzymes, lipid profile and atherogenic indices, blood pressure and anthropometric values were assessed pre and post-treatment. Results: Resveratrol supplementation reduced body weight (from 88.75 ± 11.41 to 87.54 ± 11.18 kg, P = 0.005) and BMI (from 31.00 ± 3.16 to 30.60 ± 3.26 kg/m², P = 0.01) significantly compared to the placebo group. A significant reduction in waist circumference was observed within resveratrol group (from 102.70 ± 7.68 to 101.39 ± 7.62 cm, P = 0.02). There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all). Conclusion : These findings indicated that resveratrol supplementation in dose and duration used in this study did not affect most of the CVD risk factors in NAFLD patients. Further studies are warranted to explain more effects of resveratrol on CVD complications of NAFLD. Registration ID in IRCT: IRCT201511233664N16.",2020,"There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all). ","['patients with NAFLD', 'patients with nonalcoholic fatty liver disease', '50 patients with NAFLD aged 20-60\xa0years', 'patients with nonalcoholic fatty liver disease (NAFLD', 'NAFLD patients']","['placebo', 'resveratrol supplementation']","['waist circumference', 'BMI', 'Serum liver enzymes, lipid profile and atherogenic indices, blood pressure and anthropometric values', 'CVD risk factors', 'lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure', 'atherogenic risk factors', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",50.0,0.254393,"There were no significant changes in lipid profile (ox-LDL, ApoA1 and ApoB), serum atherogenic indices (LDL-C/HDL-C, ApoB/ApoA1, ox-LDL/ApoB, LDL-C/ox-LDL and AIP), liver enzymes (AST, ALT, ALP and GGT), hip circumference, waist-to-hip ratio and blood pressure in either group (P > 0.05 for all). ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Farzin', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rafraf', 'Affiliation': 'Nutrition Research Center, Department of Community Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Road Traffic Injury Research Center, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shirmohammadi', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000528'] 1181,30239113,Regional anesthesia with epinephrine-containing lidocaine reduces pericatheter bleeding after tunneled hemodialysis catheter placement.,"INTRODUCTION Pericatheter bleeding (PB) following tunneled hemodialysis catheter (THC) placement is a common phenomenon. In addition to complicating securement of the THC, the PB may loosen the adhesive catheter dressing and delay wound healing. The primary aim of this study was to determine whether epinephrine-containing local anesthetics rather than plain ones reduce superficial PB after THC placement. METHODS The study was based on the retrospective analysis of the prospectively gathered data. Forty-six patients receiving local analgesia during THC placement were randomly assigned in a double-blind manner to two groups according to local anesthetic mixtures used (n =22 to prilocaine group [group 1]; n =24 to epinephrine-containing lidocaine group [group 2]). Presence or absence of PB after the THC placement was evaluated. Differences between groups with and without controlling other variables were statistically analyzed. FINDINGS Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003. Use of epinephrine-containing lidocaine (group 2) was associated with a reduction in the likelihood of PB (Odds ratio = 0.017). Meanwhile, use of prilocaine (group 1) had 59.7 times higher odds in the likelihood of PB after THC placement. Lower rate of systolic blood pressure (SBP) in group 2 patients after 5 minutes of injections was also noted, P = 0.008. Epinephrine-containing lidocaine was well tolerated and caused no significant cardiovascular disturbance. DISCUSSION Local infiltration of epinephrine-containing lidocaine instead of plain local anesthetics during THC insertion may reduce superficial PB and improve patient comfort.",2019,"FINDINGS Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003.","['after tunneled hemodialysis catheter placement', 'Forty-six patients receiving local analgesia during THC placement']","['tunneled hemodialysis catheter (THC) placement', 'local anesthetic mixtures', 'epinephrine-containing lidocaine', 'epinephrine-containing local anesthetics rather than plain', 'prilocaine', 'Epinephrine-containing lidocaine']","['pericatheter bleeding', 'PB', 'superficial PB', 'Lower rate of systolic blood pressure (SBP']","[{'cui': 'C0179760', 'cui_str': 'Hemodialysis catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0179760', 'cui_str': 'Hemodialysis catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",46.0,0.112234,"FINDINGS Epinephrine-containing lidocaine (group 2) significantly reduced PB in comparison with prilocaine, P = 0.003.","[{'ForeName': 'Ilhan Nahit', 'Initials': 'IN', 'LastName': 'Mutlu', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Kocak', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Baykara Ulusan', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kivilcim', 'Initials': 'K', 'LastName': 'Ulusan', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Semih', 'Initials': 'MS', 'LastName': 'Cakir', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kilickesmez', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Istanbul Training and Research Hospital, Istanbul, Turkey.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12686'] 1182,30782070,Effectiveness of telemonitoring-enhanced support over structured telephone support in reducing heart failure-related healthcare utilization in a multi-ethnic Asian setting.,"AIMS Our study aimed to compare the effectiveness of telemonitoring over structured telephone support in reducing heart failure-related healthcare utilization. METHODS This was a non-randomised controlled study comparing 150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received structured telephone support after rejecting telemonitoring. Patient activation, knowledge and self-management levels were measured at baseline and the one year upon programme completion using the Patient Activation Measure, the Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively. Differences in heart failure-related and all-cause hospitalization rates, total bed days and mortality rates at 180 days and at one year, knowledge and self-management scores and total cost of care between groups at one year were analysed. RESULTS Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support. Significant difference in adjusted 180-day all-cause bed days (telemonitoring: five days versus structured telephone support: 9.8 days), heart failure-related bed days (telemonitoring: 1.2 days versus structured telephone support: six days) and adjusted one-year heart failure-related bed days (telemonitoring: 2.2 days versus structured telephone support: 6.6 days) were observed. Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p  = 0.02). Estimated mean maintenance and confidence scores were significantly higher in the telemonitoring group at one year. No differences in all-cause and HF-related readmission rates and knowledge levels were observed. The one-year total cost of care was predicted to be Singapore dollars (SG$) 2774.4 lower ( p  = 0.07) in telemonitoring. CONCLUSION In conclusion, telemonitoring was associated with lower all-cause and heart failure-related total bed days at 180 days, lower heart failure-related total bed days and total cost of care at one year as compared with structured telephone support.",2019,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","['Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support', 'a multi-ethnic Asian setting', '150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received']","['telemonitoring over structured telephone support', 'structured telephone support after rejecting telemonitoring', 'telemonitoring-enhanced support over structured telephone support']","['Patient activation, knowledge and self-management levels', 'knowledge and self-management scores and total cost of care', 'heart failure', 'Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively', 'heart failure-related and all-cause hospitalization rates, total bed days and mortality rates', 'heart failure-related healthcare utilization', 'Estimated mean maintenance and confidence scores', 'Singapore dollars (SG', 'heart failure-related total bed days and total cost of care', 'cause and HF-related readmission rates and knowledge levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0222045'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",150.0,0.0585862,"Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02).","[{'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Leng Chow', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Chaw Yu K', 'Initials': 'CYK', 'LastName': 'Aung', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Shao Chuen', 'Initials': 'SC', 'LastName': 'Tong', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Geraldine Sl', 'Initials': 'GS', 'LastName': 'Goh', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'MacDonald', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Angela Nk', 'Initials': 'AN', 'LastName': 'Ng', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Atikah E', 'Initials': 'AE', 'LastName': 'Ahmad', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Mei Foon', 'Initials': 'MF', 'LastName': 'Yap', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Leong', 'Affiliation': 'Thomson Medical Centre Hospital, Singapore.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Bruege', 'Affiliation': 'Philips Population Health Management, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Tesanovic', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Riistama', 'Affiliation': 'Philips Research, Eindhoven, The Netherlands.'}, {'ForeName': 'Sze Yunn', 'Initials': 'SY', 'LastName': 'Pang', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Erazo', 'Affiliation': 'Health Informatics and Population Management, Philips ASEAN Pacific, Singapore.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18825164'] 1183,30793412,Complete withdrawal is the most feasible treatment for medication-overuse headache: A randomized controlled open-label trial.,"BACKGROUND Complete stop of acute medication and/or migraine medication for treatment of medication-overuse headache (MOH) has previously been reported more effective in reducing headache days and migraine days per month compared with restricted intake of acute medication. However, it is unknown whether complete stop or restricted intake is the most feasible treatment for patients. OBJECTIVES To investigate whether feasibility of withdrawal in MOH is different between complete stop of acute medication and restricted intake, and whether reductions in headache-related medication dependence, anxiety and depression differ between the treatments. METHODS Medication-overuse headache patients were included in a prospective, open-label, outpatient study and randomized to two months of withdrawal with either no analgesics or acute migraine medication (programme A) or acute medication restricted to 2 days/week (programme B). After 6 and 12 months, patients graded feasibility of withdrawal. Dependence was measured by Severity of Dependence Scale (SDS), while anxiety and depression were measured by Hospital Anxiety and Depression Scale (HADS). RESULTS We included 72 MOH patients with primary migraine and/or tension-type headache. Forty-nine completed withdrawal and the SDS questionnaire at 12-month follow-up, and the feasibility of withdrawal was significantly higher in programme A compared to programme B (p < 0.001). At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048). CONCLUSIONS Withdrawal with complete stop of acute medication was more feasible and most effective in reducing headache-related anxiety compared with restricted intake. SIGNIFICANCE A complete stop of all analgesics is the most effective treatment for MOH regarding reduction in headache days but has often been regarded as too challenging for patients. However, in this study, complete stop appears to be more feasible compared with restricted intake of analgesics seen from the patients' perspective.",2019,"At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048). ","['72 MOH patients with primary migraine and/or tension-type headache', 'Medication-overuse headache patients', 'patients']",['withdrawal with either no analgesics or acute migraine medication (programme A) or acute medication restricted to 2\xa0days/week (programme B'],"['anxiety score', 'headache-related anxiety', 'SDS questionnaire', 'Hospital Anxiety and Depression Scale (HADS', 'feasibility of withdrawal', 'Severity of Dependence Scale (SDS), while anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0033893', 'cui_str': 'Tension-Type Headache'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",72.0,0.0379628,"At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048). ","[{'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Copenhagen, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1383'] 1184,31699046,"The impact of an intervention to increase uptake to structured self-management education for people with type 2 diabetes mellitus in primary care (the embedding package), compared to usual care, on glycaemic control: study protocol for a mixed methods study incorporating a wait-list cluster randomised controlled trial.","BACKGROUND Approximately 425 million people globally have diabetes, with ~ 90% of these having Type 2 Diabetes Mellitus (T2DM). This is a condition that leads to a poor quality of life and increased risk of serious health complications. Structured self-management education (SSME) has been shown to be effective in improving glycaemic control and patient related outcome measures and to be cost-effective. However, despite the demonstrated benefits, attendance at SSME remains low. An intervention has been developed to embed SSME called the 'Embedding Package'. The intervention aims to address barriers and enhance enablers to uptake of SSME at patient, healthcare professional and organisational levels. It comprises a marketing strategy, user friendly and effective referral pathways, new roles to champion SSME and a toolkit of resources. METHODS A mixed methods study incorporating a wait-list cluster randomised trial and ethnographic study, including 66 UK general practices, will be conducted with two intervention start times (at 0 and 9 months), each followed by an active delivery phase. At 18 months, the intervention will cease to be actively delivered and a 12 month observational follow-up phase will begin. The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an 'Embedder' and a toolkit of resources for patients, healthcare professionals and other key stakeholders. The primary aim is, through increasing uptake to and attendance at SSME, to reduce HbA1c in people with T2DM compared with usual care. Secondary objectives include: assessing whether there is an increase in referral to and uptake of SSME and improvements in biomedical and psychosocial outcomes; an assessment of the sustainability of the Embedding Package; contextualising the process of implementation, sustainability of change and the 'fit' of the Embedding Package; and an assessment of the cost-effectiveness of the Embedding Package. DISCUSSION This study will assess the effectiveness, cost-effectiveness and sustainability of the Embedding Package, an intervention which aims to improve biomedical and psychosocial outcomes of people with T2DM, through increased referral to and uptake of SSME. TRIAL REGISTRATION International Standard Randomised Controlled Trials Number ISRCTN23474120. Assigned 05/04/2018. The study was prospectively registered. On submission of this manuscript practice recruitment is complete, participant recruitment is ongoing and expected to be completed by the end of 2019.",2019,"The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an 'Embedder' and a toolkit of resources for patients, healthcare professionals and other key stakeholders.","['Approximately 425 million people globally have diabetes, with ~\u200990% of these having Type 2 Diabetes Mellitus (T2DM', '66 UK general practices', 'people with type 2 diabetes mellitus in primary care (the embedding package', 'people with T2DM compared with usual care', 'people with T2DM']","['Structured self-management education (SSME', 'structured self-management education']","[""referral to and uptake of SSME and improvements in biomedical and psychosocial outcomes; an assessment of the sustainability of the Embedding Package; contextualising the process of implementation, sustainability of change and the 'fit' of the Embedding Package; and an assessment of the cost-effectiveness of the Embedding Package""]","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.130588,"The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an 'Embedder' and a toolkit of resources for patients, healthcare professionals and other key stakeholders.","[{'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Kristunas', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Eborall', 'Affiliation': 'Biostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies Centre , University Road, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Glab', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Huddlestone', 'Affiliation': 'Biostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies Centre , University Road, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Martin', 'Affiliation': 'THIS Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Northern', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Patterson', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Pritchard', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Schreder', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Stribling', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Centre for Reproduction Research, School of Applied Social Science, De Montfort University, Leicester, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Biostatistics Research Group, Department of Health Sciences, College of Life Sciences, University of Leicester, George Davies Centre , University Road, Leicester, LE1 7RH, UK. Lg48@le.ac.uk.'}]",BMC family practice,['10.1186/s12875-019-1038-0'] 1185,31155473,Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions.,"BACKGROUND Mobile dietary self-monitoring methods allow for objective assessment of adherence to self-monitoring; however, the best way to define self-monitoring adherence is not known. OBJECTIVE The objective was to identify the best criteria for defining adherence to dietary self-monitoring with mobile devices when predicting weight loss. DESIGN This was a secondary data analysis from two 6-month randomized trials: Dietary Intervention to Enhance Tracking with Mobile Devices (n=42 calorie tracking app or n=39 wearable Bite Counter device) and Self-Monitoring Assessment in Real Time (n=20 kcal tracking app or n=23 photo meal app). PARTICIPANTS/SETTING Adults (n=124; mean body mass index=34.7±5.6) participated in one of two remotely delivered weight-loss interventions at a southeastern university between 2015 and 2017. INTERVENTION All participants received the same behavioral weight loss information via twice-weekly podcasts. Participants were randomly assigned to a specific diet tracking method. MAIN OUTCOME MEASURES Seven methods of tracking adherence to self-monitoring (eg, number of days tracked, and number of eating occasions tracked) were examined, as was weight loss at 6 months. STATISTICAL ANALYSES PERFORMED Linear regression models estimated the strength of association (R 2 ) between each method of tracking adherence and weight loss, adjusting for age and sex. RESULTS Among all study completers combined (N=91), adherence defined as the overall number of days participants tracked at least two eating occasions explained the most variance in weight loss at 6 months (R 2 =0.27; P<0.001). Self-monitoring declined over time; all examined adherence methods had fewer than half the sample still tracking after Week 10. CONCLUSIONS Using the total number of days at least two eating occasions are tracked using a mobile self-monitoring method may be the best way to assess self-monitoring adherence during weight loss interventions. This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.",2019,This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.,"['Adults', 'participated in one of two remotely delivered weight-loss interventions at a southeastern university between 2015 and\xa02017', 'n=124; mean body mass index=34.7±5.6']","['Dietary Intervention to Enhance Tracking with Mobile Devices (n=42 calorie tracking app or n=39 wearable Bite Counter device) and Self-Monitoring Assessment in Real Time', 'Mobile Dietary Self-Monitoring and Assessing Tracking', 'specific diet tracking method']","[' number of days tracked, and number of eating occasions tracked', 'weight loss', 'tracking adherence to self-monitoring (eg']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]",,0.0490755,This study shows that self-monitoring rates decline quickly and elucidates potential times for early interventions to stop the reductions in self-monitoring.,"[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Caroline Glagola', 'Initials': 'CG', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Alycia K', 'Initials': 'AK', 'LastName': 'Boutté', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hoover', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Muth', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.012'] 1186,30801523,"Phase I/II Trial of Liver-derived Mesenchymal Stem Cells in Pediatric Liver-based Metabolic Disorders: A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem) in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients.","BACKGROUND Regenerative medicine using stem cell technology is an emerging field that is currently tested for inborn and acquired liver diseases. OBJECTIVE This phase I/II prospective, open label, multicenter, randomized trial aimed primarily at evaluating the safety of Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem) in pediatric patients with urea cycle disorders (UCDs) or Crigler-Najjar (CN) syndrome 6 months posttransplantation. The secondary objective included the assessment of safety up to 12 months postinfusion and of preliminary efficacy. METHODS Fourteen patients with UCDs and 6 with CN syndrome were divided into 3 cohorts by body weight and intraportally infused with 3 doses of HepaStem. Clinical status, portal vein hemodynamics, morphology of the liver, de novo detection of circulating anti-human leukocyte antigen antibodies, and clinically significant adverse events (AEs) and serious adverse events to infusion were evaluated by using an intent-to-treat analysis. RESULTS The overall safety of HepaStem was confirmed. For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the serious adverse events, of which 38% occurred within 1 month postinfusion. There was a trend of higher events in UCD as compared with CN patients. Segmental left portal vein thrombosis occurred in 1 patient and intraluminal local transient thrombus in a second patient. The other AEs were in line with expectations for catheter placement, cell infusion, concomitant medications, age, and underlying diseases. CONCLUSIONS This study led to European clinical trial authorization for a phase II study in a homogeneous patient cohort, with repeated infusions and intermediate doses.",2019,"For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the SAEs, of which 38% occurred within one month post-infusion.","['Fourteen patients with UCDs and 6 with CN syndrome', 'Pediatric Liver Based Metabolic Disorders', 'Urea Cycle Disorders and Crigler-Najjar Syndrome patients', 'homogeneous patient cohort, with repeated infusions and intermediate doses', 'pediatric patients with urea cycle disorders (UCDs) or Crigler-Najjar (CN) syndrome 6 months post-transplantation']","['Heterologous Human Adult Liver-Derived Progenitor Cells (HepaStem®', 'Liver Derived Mesenchymal Stem Cells', 'Heterologous Human Adult Liver-derived Progenitor Cells (HepaStem']","['patient-month incidence rate', 'overall safety of HepaStem', 'Segmental left portal vein thrombosis']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}, {'cui': 'C0154246', 'cui_str': 'Urea Cycle Disorders'}, {'cui': 'C0010324', 'cui_str': 'Familial Nonhemolytic Unconjugated Hyperbilirubinemia'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0933785', 'cui_str': 'Left portal vein'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",14.0,0.0438568,"For the entire study period, patient-month incidence rate was 1.76 for the AEs and 0.21 for the SAEs, of which 38% occurred within one month post-infusion.","[{'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Smets', 'Affiliation': 'Department of Paediatrics, Paediatric Gastroenterology and Hepatology Unit, Cliniques Universitaires St Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Dobbelaere', 'Affiliation': ""Medical Reference Center for Inherited Metabolic Diseases, University Children's Hospital Jeanne de Flandre and RADEME Research Team for Rare Metabolic and Developmental Diseases, EA 7364, University Lille 2, CHRU Lille, Lille, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McKiernan', 'Affiliation': ""Liver Unit, Birmingham Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dionisi-Vici', 'Affiliation': 'Department of Hepatology, Gastroenterology and Nutrition, Ospedale Pediatrico Bambino Gesù di Roma, Roma, Italy.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Broué', 'Affiliation': 'Hépatologie pédiatrique et maladies héréditaires du métabolisme, Centre de compétences maladies héréditaires du métabolisme, Hôpital des enfants, CHU Toulouse, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Jacquemin', 'Affiliation': 'Pediatric Hepatology and Liver Transplantation Unit, Reference Centre for Rare Liver Diseases, CHU Bicêtre, Assistance Publique, Hôpitaux de Paris, DHU Hepatinov, INSERM 1174, University Paris Sud, Paris, France.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Lopes', 'Affiliation': 'Department of Pediatrics, Gastroenterology Unit, Medical Faculty of Lisbon, University Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gonçalves', 'Affiliation': 'Hospital Pediátrico de Coimbra, Centro Hospitalar da Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mandel', 'Affiliation': ""Department of Pediatrics, Metabolic Unit, Rambam Medical Center, Meyer Children's Hospital, Haifa, Israel.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pawlowska', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutritional Disorders, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kamińska', 'Affiliation': ""Department of Gastroenterology, Hepatology and Nutritional Disorders, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shteyer', 'Affiliation': 'Department of Pediatrics, Hadassah Ein-Kerem Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Torre', 'Affiliation': 'Department of Hepatology, Gastroenterology and Nutrition, Ospedale Pediatrico Bambino Gesù di Roma, Roma, Italy.'}, {'ForeName': 'Riki', 'Initials': 'R', 'LastName': 'Shapiro', 'Affiliation': ""Liver Transplantation Unit, Institute of Gastroenterology, Schneider Children's Medical Center of Israel, Petach Tikva, Israel.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Eyskens', 'Affiliation': 'Paediatric department, Universitair Ziekenhuis Antwerpen, Edegem, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clapuyt', 'Affiliation': 'Department of Radiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gissen', 'Affiliation': 'GOSH UCL Biomedical Center, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Danièle', 'Initials': 'D', 'LastName': 'Pariente', 'Affiliation': 'Department of Radiology, CHU Bicêtre, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Grunewald', 'Affiliation': 'Centre for Inborn Errors of Metabolism, Great Ormond Street Hospital and Institute of Child Health, UCL, London, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Yudkoff', 'Affiliation': ""Mass Spectroscopy Center, The Children's Hospital of Philadelphia, Philadelphia, USA.""}, {'ForeName': 'Maria Mercedes', 'Initials': 'MM', 'LastName': 'Binda', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Najimi', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Belmonte', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'de Vos', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Thonnard', 'Affiliation': 'Promethera Biosciences, Mont-Saint-Guibert, Belgium.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Sokal', 'Affiliation': 'Department of Paediatrics, Paediatric Gastroenterology and Hepatology Unit, Cliniques Universitaires St Luc, Université Catholique de Louvain, Brussels, Belgium.'}]",Transplantation,['10.1097/TP.0000000000002605'] 1187,30801548,Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.,"BACKGROUND The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail. METHODS TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids. RESULTS Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA. CONCLUSIONS De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.",2019,"The incidence of viral infections (17.2% versus 29.2%; p<0.001), CMV infections (8.1% versus 20.1%; p<0.001), CMV syndrome (13.6% versus 23.0%, p=0.044) and BKV infections (4.3% versus 8.0%, p<0.001) were less frequent with everolimus.","['de novo kidney transplant patients', 'individual kidney transplant recipients', 'de novo kidney transplant recipients', 'De Novo Kidney Transplants']","['everolimus with reduced-exposure CNI (N=1014) or mycophenolic acid (MPA) with standard-exposure CNI (N=1012), both with induction and corticosteroids', 'Everolimus', 'standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy']","['CMV syndrome', 'incidence of viral infections', 'diarrhea, nausea, vomiting, leukopenia, tremor and insomnia', 'CMV infections', 'adverse events', 'Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia and wound healing complications', 'BKV infections', 'CMV infection']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0149745', 'cui_str': 'Mouth Ulcer'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0213168,"The incidence of viral infections (17.2% versus 29.2%; p<0.001), CMV infections (8.1% versus 20.1%; p<0.001), CMV syndrome (13.6% versus 23.0%, p=0.044) and BKV infections (4.3% versus 8.0%, p<0.001) were less frequent with everolimus.","[{'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Department of Nephrology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Viklicky', 'Affiliation': 'Department of Nephrology, Transplant Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Basic-Jukic', 'Affiliation': 'Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Cassuto', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Hôpital Pasteur, Nice, France.'}, {'ForeName': 'Dean Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': 'Department of Nephrology, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Adel Bakr', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Valter D', 'Initials': 'VD', 'LastName': 'Garcia', 'Affiliation': 'Department of Renal Transplantation, Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Huynh-Do', 'Initials': 'HD', 'LastName': 'Uyen', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital Bern, Bern, Switzerland.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Central and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Myoung', 'Initials': 'M', 'LastName': 'Soo Kim', 'Affiliation': 'Department of Transplantation Surgery, Severance Hospital Yonsei University Health System, Seoul, Republic of Korea.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Kuypers', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Gasthuisberg University Hospital, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Buchler', 'Affiliation': 'Department of Nephrology and Renal Transplantation, CHRU de Tours, Hôpital Bretonneau, Tours, France.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Citterio', 'Affiliation': 'Policlinico Foundation, A Gemelli University, IRCCS, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Hernandez Gutierrez', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Department of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000002626'] 1188,31701891,"Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial.","BACKGROUND Chronic cluster headache is the most disabling form of cluster headache. The mainstay of treatment is attack prevention, but the available management options have little efficacy and are associated with substantial side-effects. In this study, we aimed to assess the safety and efficacy of sphenopalatine ganglion stimulation for treatment of chronic cluster headache. METHODS We did a randomised, sham-controlled, parallel group, double-blind, safety and efficacy study at 21 headache centres in the USA. We recruited patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments. Participants were randomly assigned (1:1) via an online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation. Patients and the clinical evaluator and surgeon were masked to group assignment. The primary efficacy endpoint, which was analysed with weighted generalised estimated equation logistic regression models, was the difference between groups in the proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain was achieved 15 min after the start of stimulation without the use of acute drugs before that timepoint. Efficacy analyses were done in all patients who were implanted with a device and provided data for at least one treated attack during the 4-week experimental phase. Safety was assessed in all patients undergoing an implantation procedure up to the end of the open-label phase of the study, which followed the experimental phase. This trial is registered with ClinicalTrials.gov, number NCT02168764. FINDINGS Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the sphenopalatine ganglion stimulation group and 48 to the control group. 36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses. The proportion of attacks for which pain relief was experienced at 15 min was 62·46% (95% CI 49·15-74·12) in the sphenopalatine ganglion stimulation group versus 38·87% (28·60-50·25) in the control group (odds ratio 2·62 [95% CI 1·28-5·34]; p=0·008). Nine serious adverse events were reported by the end of the open-label phase. Three of these serious adverse events were related to the implantation procedure (aspiration during intubation, nausea and vomiting, and venous injury or compromise). A fourth serious adverse event was an infection that was attributed to both the stimulation device and the implantation procedure. The other five serious adverse events were unrelated. There were no unanticipated serious adverse events. INTERPRETATION Sphenopalatine ganglion stimulation seems efficacious and is well tolerated, and potentially offers an alternative approach to the treatment of chronic cluster headache. Further research is need to clarify its place in clinical practice. FUNDING Autonomic Technologies.",2019,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"['Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the', 'chronic cluster headache', '21 headache centres in the USA', 'patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments', '36 patients in the']","['sphenopalatine ganglion stimulation', 'online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation']","['Safety', 'Safety and efficacy', 'nausea and vomiting, and venous injury or compromise', 'Nine serious adverse events', 'proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain', 'safety and efficacy', 'proportion of attacks for which pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0229062', 'cui_str': 'Pterygopalatine Ganglia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",93.0,0.241285,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""National Institute for Health Research-Wellcome Trust King's Clinical Research Facility and South London and the Maudsley Biomedical Research Centre, King's College London, London, UK. Electronic address: peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Sahai-Srivastava', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Kezirian', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Calhoun', 'Affiliation': 'Carolina Headache Institute, Durham, NC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Matthews', 'Affiliation': 'Carolinas HealthCare System, Charlotte, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, CT, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Costantino', 'Affiliation': 'New York Head and Neck Institute, Northwell Health System, New York, NY, USA.'}, {'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Headache and Facial Pain Program, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zuniga', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Laszlo L', 'Initials': 'LL', 'LastName': 'Mechtler', 'Affiliation': 'Dent Headache Center, Dent Neurologic Institute, Buffalo, NY, USA.'}, {'ForeName': 'Saurin R', 'Initials': 'SR', 'LastName': 'Popat', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Rezai', 'Affiliation': 'Rockefeller Neuroscience Institute, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30322-9'] 1189,30803323,The feasibility of online video calling to engage patients with cystic fibrosis in exercise training.,"INTRODUCTION Physical activity, including structured exercise, is an essential component in the management of cystic fibrosis. The use of telehealth such as video-calling may be a useful method for the delivery of exercise and physical activity interventions, though the feasibility of this remains unknown. METHODS Nine patients with cystic fibrosis (three female, six male, 30.9 ± 8.7 years) volunteered to participate. Participants completed an eight-week exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist. Feasibility was assessed by demand, implementation, practicality and acceptability. Changes in anthropometric, pulmonary, physical activity and quality of life variables were also assessed. RESULTS Two male participants withdrew from the study, citing lack of available time. The remaining participants found use of Skype useful, with a mean satisfaction rating of 9/10, and three participants requesting to continue the sessions beyond the duration of the study. Mean compliance with sessions was 68%, with mean duration of sessions being 20 min. A total of 25% of calls suffered from technical issues such as video or audio lags. Anthropometric, pulmonary, physical activity and quality of life variables remained unchanged over the course of the study period. DISCUSSION The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants. Findings have implications for clinical practice and could allow care teams to engage patients remotely in exercise. Further research is required to assess the efficacy of this modality on increasing physical activity and associated health outcomes.",2019,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","['Nine patients with cystic fibrosis (three female, six male, 30.9\u2009±\u20098.7 years) volunteered to participate', 'engage patients with cystic fibrosis in exercise training', 'Two male participants withdrew from the study, citing lack of available time']","['exercise training intervention conducted via Skype, using personalised exercises, with all sessions supervised by an exercise therapist', 'exercise intervention', 'online video calling']","['Anthropometric, pulmonary, physical activity and quality of life variables', 'Mean compliance', 'Changes in anthropometric, pulmonary, physical activity and quality of life variables', 'demand, implementation, practicality and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",2.0,0.0180621,"The use of Skype to deliver an exercise intervention to patients withcystic fibrosis was found to be technologically feasible, and acceptable among participants.","[{'ForeName': 'Owen W', 'Initials': 'OW', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Shelley', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Trott', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Bowhay', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Research and Development Directorate, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Sheldon', 'Affiliation': 'Department of Respiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, UK.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19828630'] 1190,30771856,"The Vitamins in Psychosis Study: A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Vitamins B 12 , B 6 , and Folic Acid on Symptoms and Neurocognition in First-Episode Psychosis.","BACKGROUND Elevated homocysteine is observed in schizophrenia and associated with illness severity. The aim of this study was to determine whether vitamins B 12 , B 6 , and folic acid lower homocysteine and improve symptomatology and neurocognition in first-episode psychosis. Whether baseline homocysteine, genetic variation, sex, and diagnosis interact with B-vitamin treatment on outcomes was also examined. METHODS A randomized, double-blind, placebo-controlled trial was used. A total of 120 patients with first-episode psychosis were randomized to an adjunctive B-vitamin supplement (containing folic acid [5 mg], B 12 [0.4 mg], and B 6 [50 mg]) or placebo, taken once daily for 12 weeks. Coprimary outcomes were change in total symptomatology (Positive and Negative Syndrome Scale) and composite neurocognition. Secondary outcomes included additional measures of symptoms, neurocognition, functioning, tolerability, and safety. RESULTS B-vitamin supplementation reduced homocysteine levels (p = .003, effect size = -0.65). B-vitamin supplementation had no significant effects on Positive and Negative Syndrome Scale total (p = .749) or composite neurocognition (p = .785). There were no significant group differences in secondary symptom domains. A significant group difference in the attention/vigilance domain (p = .024, effect size = 0.49) showed that the B-vitamin group remained stable and the placebo group declined in performance. In addition, 14% of the sample had elevated baseline homocysteine levels, which was associated with greater improvements in one measure of attention/vigilance following B-vitamin supplementation. Being female and having affective psychosis was associated with improved neurocognition in select domains following B-vitamin supplementation. Genetic variation did not influence B-vitamin treatment response. CONCLUSIONS While 12-week B-vitamin supplementation might not improve overall psychopathology and global neurocognition, it may have specific neuroprotective properties in attention/vigilance, particularly in patients with elevated homocysteine levels, patients with affective psychosis, and female patients. Results support a personalized medicine approach to vitamin supplementation in first-episode psychosis.",2019,"RESULTS B-vitamin supplementation reduced homocysteine levels (p = .003, effect size = -0.65).","['patients with elevated homocysteine levels, patients with affective psychosis, and female patients', 'Psychosis Study', 'First-Episode Psychosis', '120 patients with first-episode psychosis']","['vitamin supplementation', 'placebo', 'Placebo', 'B-vitamin supplementation', 'Vitamins B 12 , B 6 , and Folic Acid', 'vitamins B 12 , B 6 , and folic acid lower homocysteine', 'adjunctive B-vitamin supplement (containing folic acid [5 mg], B 12 [0.4 mg], and B 6 [50 mg]) or placebo']","['Positive and Negative Syndrome Scale total', 'composite neurocognition', 'attention/vigilance domain', 'total symptomatology (Positive and Negative Syndrome Scale) and composite neurocognition', 'homocysteine levels', 'additional measures of symptoms, neurocognition, functioning, tolerability, and safety', 'overall psychopathology and global neurocognition', 'attention/vigilance', 'elevated baseline homocysteine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0001723', 'cui_str': 'Psychoses, Affective'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3714647', 'cui_str': 'B Vitamins'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",120.0,0.534851,"RESULTS B-vitamin supplementation reduced homocysteine levels (p = .003, effect size = -0.65).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Firth', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; NICM Health Research Institute, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tina-Marie', 'Initials': 'TM', 'LastName': 'Proffitt', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; School of Psychology, University of Waikato, Hamilton, Waikato, New Zealand.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Berger', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychiatric University Clinic, Zurich, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'Department of Anatomy and Neuroscience, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Michaela K', 'Initials': 'MK', 'LastName': ""O'Regan"", 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Papas', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy C B', 'Initials': 'TCB', 'LastName': 'Stephens', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Psychiatry, Donegal Mental Health Service, Letterkenny University Hospital, Letterkenny, Donegal, Republic of Ireland. Electronic address: drcolinodonnell@yahoo.com.'}]",Biological psychiatry,['10.1016/j.biopsych.2018.12.018'] 1191,31414891,CT in Differentiating Complicated From Uncomplicated Appendicitis: Presence of Any of 10 CT Features Versus Radiologists' Gestalt Assessment.,"OBJECTIVE. The purpose of this study is to propose a sensitive CT criterion (the presence of any of 10 CT features) for complicated appendicitis that could be used in the nonoperative management of appendicitis and to compare the diagnostic performance of this sensitive CT criterion with that of gestalt assessment. MATERIALS AND METHODS. This retrospective study, which was conducted in a tertiary teaching hospital, included 100 patients with suspected appendicitis on CT. Complicated appendicitis, defined as gangrenous or perforated appendicitis, was pathologically or surgically confirmed in 32 patients. Six radiologists independently determined the presence of 10 previously reported CT features of complicated appendicitis (contrast enhancement defect of the appendiceal wall, abscess, extraluminal air, intraluminal air, extraluminal appendicolith, intraluminal appendicolith, moderate-to-severe periappendiceal fat stranding, periappendiceal fluid, ileus, and ascites) and rated the likelihood score for complicated appendicitis using gestalt assessment. The sensitivity and specificity of CT for complicated appendicitis were measured by the presence of any of 10 CT features (the any-of-10-features criterion) and by the radiologists' gestalt assessment. Pooled sensitivity and specificity were compared using a generalized linear mixed model. RESULTS. The pooled sensitivity of the presence of any of 10 CT features was higher than that of gestalt assessment (92% vs 64%; difference, 28% [95% CI, 10-46%]; p < 0.001), although the pooled specificity was lower (43% vs 76%; difference, -33% [95% CI, -48% to -17%]; p < 0.001). CONCLUSION. The pooled sensitivity of the presence of any of 10 CT features was higher than that of gestalt assessment, at the cost of lower specificity. For prudent selection of patients who should receive nonoperative treatment of appendicitis, the any-of-10-features criterion may be used to decrease treatment failure associated with a false-negative diagnosis of complication.",2019,"Complicated appendicitis, defined as gangrenous or perforated appendicitis, was pathologically or surgically confirmed in 32 patients.","['100 patients with suspected appendicitis on CT', 'Uncomplicated Appendicitis']",['CT'],"['pooled specificity', 'sensitivity and specificity of CT for complicated appendicitis', 'Pooled sensitivity and specificity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]",[],"[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]",100.0,0.0249278,"Complicated appendicitis, defined as gangrenous or perforated appendicitis, was pathologically or surgically confirmed in 32 patients.","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundanggu, Seongnam-si, Gyeonggi-do 463-707, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundanggu, Seongnam-si, Gyeonggi-do 463-707, Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundanggu, Seongnam-si, Gyeonggi-do 463-707, Korea.'}, {'ForeName': 'Woo Joo', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Inha University, Incheon, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundanggu, Seongnam-si, Gyeonggi-do 463-707, Korea.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical and Experimental Medicine (IKE), Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Program in Biomedical Radiation Sciences, Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.21331'] 1192,30768429,Using Electronic Clinical Decision Support in Patient-Centered Medical Homes to Improve Management of Diabetes in Primary Care: The DECIDE Study.,"This prospective, randomized, real-world study aimed to examine the impact of electronic health record-based clinical decision support (CDS) tools on the management of diabetes in small- to medium-sized primary care practices participating in Delaware's patient-centered medical home project. Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals. Physicians and staff reported that the CDS toolkit empowered them to be more involved in clinical decision-making, thereby helping to improve diabetes care. However, all cited significant barriers to fully implementing team-based CDS, predominantly involving time and reimbursement.",2019,"Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals.","['Patient-Centered Medical Homes to Improve Management of Diabetes in Primary Care', ""diabetes in small- to medium-sized primary care practices participating in Delaware's patient-centered medical home project""]",['electronic health record-based clinical decision support (CDS) tools'],['hemoglobin A1c and low-density lipoprotein cholesterol'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0011198', 'cui_str': 'Delaware'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0188189,"Overall, use of CDS systems was associated with greater reductions from baseline in hemoglobin A1c and low-density lipoprotein cholesterol, and more patients achieving treatment goals.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Delaware Valley Outcomes Research, Newark, Delaware (Dr Gill and Ms Turk); independent consultant (Dr Kucharski); Sanofi US, Inc, Bridgewater, New Jersey (Dr Pan); and Regeneron Pharmaceuticals Inc, Tarrytown, New York (Dr Wei).'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kucharski', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Turk', 'Affiliation': ''}, {'ForeName': 'Chunshen', 'Initials': 'C', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ''}]",The Journal of ambulatory care management,['10.1097/JAC.0000000000000267'] 1193,30773689,Ethanol Lock Therapy for the Prevention of Nontunneled Catheter-Related Bloodstream Infection in Pediatric Patients.,"BACKGROUND Ethanol lock therapy (ELT) has been reported as being effective in preventing central line-associated bloodstream infection (CLABSI) in tunneled (or long-term) central venous catheters (CVCs). To the best of our knowledge, no studies have evaluated this therapy in relation to nontunneled (or short-term) CVCs. OBJECTIVE To evaluate the effectiveness of ELT in preventing CLABSI in nontunneled CVC in pediatric patients. METHODS This randomized clinical trial was conducted with children aged 0-5 years and >2 kg in weight, in whom a double-lumen polyurethane nontunneled CVC had been inserted. Patients with catheters inserted in an emergency situation, critically ill patients, and/or those with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study. The variables evaluated were CLABSI, etiological agents, adverse events, and the mechanical effects of ethanol on the catheter (breakage and obstruction). RESULTS The CLABSI rate was lower in the ELT group compared with the control group (P = 0.0177). However, when the occurrence of CLABSI was evaluated per 1000 catheter-days, no significant difference was found between the groups (P = 0.077). The frequency of side effects and catheter breakage was greater in the ELT group (P = 0.0001 and P = 0.0005, respectively). CONCLUSIONS The CLABSI rate was statistically significantly reduced in the ELT group compared with the controls, but the analysis of frequency per catheter-day showed no significant difference between the groups. Thus, we should not recommend ELT for CLABSI prophylaxis in nontunneled polyurethane CVC, which requires further clinical trials.",2019,"The frequency of side effects and catheter breakage was greater in the ELT group (P = 0.0001 and P = 0.0005, respectively). ","['Patients with catheters inserted in an emergency situation, critically ill patients, and/or those with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study', 'children aged 0-5 years and >2 kg in weight, in whom a double-lumen polyurethane nontunneled CVC had been inserted', 'pediatric patients', 'Pediatric Patients']","['Ethanol lock therapy (ELT', 'Ethanol Lock Therapy', 'ELT']","['CLABSI', 'CLABSI rate', 'frequency of side effects and catheter breakage', 'CLABSI, etiological agents, adverse events, and the mechanical effects of ethanol on the catheter (breakage and obstruction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032616', 'cui_str': 'Ostamer'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3665944', 'cui_str': 'Catheter breakage'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.0387823,"The frequency of side effects and catheter breakage was greater in the ELT group (P = 0.0001 and P = 0.0005, respectively). ","[{'ForeName': 'Bellisa Caldas', 'Initials': 'BC', 'LastName': 'Lopes', 'Affiliation': 'Division of Pediatric Surgery, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Paulo Sérgio Gomes Nogueira', 'Initials': 'PSGN', 'LastName': 'Borges', 'Affiliation': 'Division of Pediatric Surgery, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Rodrigo Melo', 'Initials': 'RM', 'LastName': 'Gallindo', 'Affiliation': 'Division of Pediatric Surgery, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Thuanne Beatriz Silva', 'Initials': 'TBS', 'LastName': 'Tenório', 'Affiliation': 'Faculdade Pernambucana de Saúde, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Lara Barreto', 'Initials': 'LB', 'LastName': 'Machado', 'Affiliation': 'Division of Pediatric Surgery, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP), Recife, Pernambuco, Brazil.'}, {'ForeName': 'Flávia Augusta', 'Initials': 'FA', 'LastName': 'de Orange', 'Affiliation': 'Division of Anesthesiology and Postgraduate Program in Palliative Care, IMIP, Recife, Pernambuco, Brazil.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1508'] 1194,30761535,The effect of mortality salience on the attitudes toward state control: The case of Russia.,"Our study examined the effects of mortality salience (MS) on attitudes toward state control in different domains in Russia. Using the theory of Conservatism as Motivated Social Cognition (CMSC) and the Terror Management Theory (TMT), we put forward two alternative hypotheses. Based on the CMSC, MS would enhance the approval of state control in different spheres, while, in line with TMT, the MS effect would be dependent on pre-existing views. The participants in the study were 450 Russian students who completed a questionnaire to measure attitudes toward state control in six spheres of life (the economy, the mass media, political parties, social organisations, science and education). After a week, they were randomly assigned one of three conditions-MS, frightening, and a neutral condition-and again completed the questionnaire on political attitudes. Our results showed that MS mostly provokes ""control shifting,"" confirming the CMSC's hypothesis. However, a separate analysis conducted among people with different pre-existing political attitudes has revealed that ""control shifting"" is more pronounced for freedom-oriented participants. We discuss these findings in line with alternative views on the nature of the MS effect and specifics of socio-political context.",2020,"Using the theory of Conservatism as Motivated Social Cognition (CMSC) and the Terror Management Theory (TMT), we put forward two alternative hypotheses.","['participants in the study were 450 Russian students who completed a questionnaire to measure attitudes toward state control in six spheres of life (the economy, the mass media, political parties, social organisations, science and education', 'different domains in Russia']",['mortality salience (MS'],['mortality salience'],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0024869', 'cui_str': 'Mass Media'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",450.0,0.0104953,"Using the theory of Conservatism as Motivated Social Cognition (CMSC) and the Terror Management Theory (TMT), we put forward two alternative hypotheses.","[{'ForeName': 'Irina S', 'Initials': 'IS', 'LastName': 'Prusova', 'Affiliation': 'Department of Psychology, National Research University Higher School of Economics, Moscow, Russian Federation.'}, {'ForeName': 'Olga A', 'Initials': 'OA', 'LastName': 'Gulevich', 'Affiliation': 'Department of Psychology, National Research University Higher School of Economics, Moscow, Russian Federation.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12571'] 1195,30187872,[Efficacy and metabolic safety of long-term treatment with ethinyl oestradiol/cyproterone and desogestrel/ethinyl oestradiol tablets in women with polycystic ovary syndrome].,"OBJECTIVE To evaluate the efficacy and metabolic safety of long-term treatment with ethinyl oestradiol/cyproteroneand desogestrel/ethinyl oestradiol tablets in women with polycystic ovary syndrome (PCOS). METHODS Women with PCOSfrom West China Second Hospital of Sichuan University enrolled between September, 2011 and August, 2013 were randomlyallocated to receive either ethinyl oestradiol/cyproterone tablets (Group A, n =355) or desogestrel/ethinyl oestradiol tablets(Group B, n =357) for a prospective observation period of 6 months. Women with insulin resistance also received metformin. Atbaseline, 3 months, and 6 months, the patients were evaluated for menstruation, acne score, body mass index (BMI), waist-tohip ratio (WHR), plasma levels of sex hormones, fasting blood glucose (FPG), HOMA-insulin resistance index (HOMA-IR), serum lipid, ovarian volume, and the number of ovarian follicles. RESULTS All the patients had a regular menstrual cycle aftertreatments. Testosterone level, acne score, LH/FSH, ovarian volume, and the number of follicles decreased significantly afterthe treatments without significant differences between the two groups. Significant increases were noted in TG, TCh, LDL, HDL, and AIP, and HDL level in group A as compared with group B ( P < 0.001). FPG decreased in both groups, and wassignificantly lower in group B at 6 months ( P < 0.05). BMI and WHR decreased in all the patients with insulin resistance aftercombination treatment with metformin ( P < 0.05), but increased significantly in patients without insulin resistance ( P < 0.05). Ingroup A, HOMA- IR significantly increased in patientswithout insulin resistance at 3 months ( P < 0.05), whereas asignificant increase was not observed until 6 months ingroup B ( P < 0.05). CONCLUSIONS Both ethinyl oestradiol/cyproterone tablets and desogestrel/ethinyl oestradioltablets can relieve the symptoms of PCOS, but it isadvisable to assess the risk of cardiovascular diseasebefore the treatments.",2018,"Significant increases were noted in TG, TCh, LDL, HDL, and AIP, and HDL level in group A as compared with group B ( P < 0.001).","['women with polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', 'Women with insulin resistance also received', 'Second Hospital of Sichuan University enrolled between September, 2011 and August, 2013 were randomlyallocated to receive either', 'Women with PCOSfrom West China']","['ethinyl oestradiol/cyproteroneand desogestrel/ethinyl oestradiol tablets', 'ethinyl oestradiol/cyproterone tablets', 'metformin', 'desogestrel/ethinyl oestradiol tablets(Group', 'ethinyl oestradiol/cyproterone tablets and desogestrel/ethinyl oestradioltablets', 'ethinyl oestradiol/cyproterone and desogestrel/ethinyl oestradiol tablets']","['FPG', 'TG, TCh, LDL, HDL, and AIP, and HDL level', 'menstruation, acne score, body mass index (BMI), waist-tohip ratio (WHR), plasma levels of sex hormones, fasting blood glucose (FPG), HOMA-insulin resistance index (HOMA-IR), serum lipid, ovarian volume, and the number of ovarian follicles', 'BMI and WHR', 'patientswithout insulin resistance', 'efficacy and metabolic safety', 'Efficacy and metabolic safety', 'Testosterone level, acne score, LH/FSH, ovarian volume, and the number of follicles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0010621', 'cui_str': 'Cyproterone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018120', 'cui_str': 'Ovarian Follicle'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}]",,0.0420829,"Significant increases were noted in TG, TCh, LDL, HDL, and AIP, and HDL level in group A as compared with group B ( P < 0.001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Su', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Liangzhi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Zhilan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Weiyao', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Qiao', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yaxian', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital/Institute of Reproductive Endocrinology and Reproductive Regulation, Western Research Institute of West China Second Hospital/Joint Laboratory for Reproductive Medicine, Sichuan University, Chengdu 610041, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.3969/j.issn.1673-4254.2018.08.03'] 1196,30099756,Comparison of Ultrasound-Guided and Landmark-Based Lumbar Punctures in Inexperienced Resident Physicians.,"OBJECTIVES We sought to determine whether US-guided lumbar puncture reduced the rate of lumbar puncture failures for providers at an academic teaching hospital with variable lumbar puncture and US experience compared to the traditional landmark-based technique. METHODS We conducted a prospective randomized controlled trial to compare US-guided lumbar puncture to the traditional landmark technique in an academic emergency department. Thirty-five patients were randomized to either have their lumbar puncture performed either via the landmark or US-guided technique. All procedures were completed by an emergency medicine resident with variable lumbar puncture and US experience. Procedural failures, the number of attempts, the time to completion, and patient pain scores were all recorded. RESULTS The adjusted odds ratio of successfully obtaining cerebrospinal fluid (CSF) in the US-guided lumbar puncture group was 2.31 compared to the landmark-based lumbar puncture group (P = .377). It took 1.54 times more attempts to obtain CSF in the landmark group as it did in the US group (P = .046). It seemed to have no effect on postprocedural pain or the time to obtain CSF. CONCLUSIONS The use of US guidance to assist in lumbar punctures did not improve the procedural success rate over traditional landmark techniques in an academic setting with novice providers. Although using US for procedural guidance significantly decreased the number of attempts, it seemed to have no effect on postprocedural pain or the time to obtain CSF.",2019,The use of US guidance to assist in lumbar punctures did not improve the procedural success rate over traditional landmark techniques in an academic setting with novice providers.,"['Thirty-five patients', 'providers at an academic teaching hospital with variable lumbar puncture and US experience', 'academic emergency department', 'Inexperienced Resident Physicians']","['lumbar puncture performed either via the landmark or US-guided technique', 'US-guided lumbar puncture', 'Ultrasound-Guided and Landmark-Based Lumbar Punctures']","['Procedural failures, the number of attempts, the time to completion, and patient pain scores', 'adjusted odds ratio of successfully obtaining cerebrospinal fluid (CSF', 'rate of lumbar puncture failures', 'postprocedural pain']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1320928', 'cui_str': 'Resident physician (occupation)'}]","[{'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",35.0,0.0287106,The use of US guidance to assist in lumbar punctures did not improve the procedural success rate over traditional landmark techniques in an academic setting with novice providers.,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Evans', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Tozer', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joyce', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vitto', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.14728'] 1197,30360964,"Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial.","BACKGROUND Biological disease-modifying anti-rheumatic drugs (bDMARDs) are recommended for radiographic axial spondyloarthritis, otherwise known as ankylosing spondylitis, when conventional therapies are not effective. We report efficacy and safety data on ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A (IL-17A), in patients with radiographic axial spondyloarthritis who have not previously been treated with bDMARDs. METHODS In this phase 3, randomised, double-blind, placebo-controlled superiority study of ixekizumab, adult patients with inadequate response or intolerance to non-steroidal anti-inflammatory drugs, an established diagnosis of radiographic axial spondyloarthritis, radiographic sacroiliitis centrally defined by modified New York criteria, and at least one spondyloarthritis feature according to the Assessment of SpondyloArthritis international Society (ASAS) criteria, were recruited from 84 sites (12 countries) in Europe, Asia, and North America. By use of a computer-generated random sequence, patients were randomly assigned (1:1:1:1) to 80 mg subcutaneous ixekizumab every two (Q2W) or four (Q4W) weeks, 40 mg adalimumab Q2W (active reference group), or placebo. The primary objective was to compare the proportion of patients achieving an ASAS40 response, a composite measure of clinical improvement in axial spondyloarthritis, at week 16 for both ixekizumab treatment groups versus the placebo group. The adalimumab reference group was included as an in-study active reference for comparison with placebo to provide additional context to interpretation of the ixekizumab study results. FINDINGS Between June 20, 2016, and Aug 22, 2017, 341 patients were randomly assigned to either the placebo group (n=87), adalimumab group (n=90), ixekizumab Q2W (n=83), or ixekizumab Q4W (n=81). At week 16, compared with placebo (16 [18%] of 87), more patients achieved ASAS40 with ixekizumab Q2W (43 [52%] of 83; p<0·0001), ixekizumab Q4W (39 [48%] of 81; p<0·0001), and adalimumab (32 [36%] of 90; p=0·0053). One serious infection occurred in each of the ixekizumab Q2W (1%), ixekizumab Q4W (1%), and adalimumab (1%) groups; none were reported with placebo. One (1%) Candida infection occurred in the adalimumab group and one (1%) patient receiving ixekizumab Q2W was adjudicated as having probable Crohn's disease. No treatment-emergent opportunistic infections, malignancies, or deaths occurred. INTERPRETATION Each dosing regimen of ixekizumab was superior to placebo for improving radiographic axial spondyloarthritis signs and symptoms in patients not previously treated with bDMARDs; the safety profile was consistent with previous indications of ixekizumab. FUNDING Eli Lilly and Company.",2018,"At week 16, compared with placebo (16 [18%] of 87), more patients achieved ASAS40 with ixekizumab Q2W (43 [52%] of 83; p<0·0001), ixekizumab Q4W (39 [48%] of 81; p<0·0001), and adalimumab (32 [36%] of 90; p=0·0053).","['adult patients with inadequate response or intolerance to non-steroidal anti-inflammatory drugs, an established diagnosis of radiographic axial spondyloarthritis, radiographic sacroiliitis centrally defined by modified New York criteria, and at least one spondyloarthritis feature according to the Assessment of SpondyloArthritis international Society (ASAS) criteria, were recruited from 84 sites (12 countries) in Europe, Asia, and North America', 'patients with radiographic axial spondyloarthritis who have not previously been treated with bDMARDs', 'patients not previously treated with bDMARDs', 'Between June 20, 2016, and Aug 22, 2017', 'patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V', '341 patients']","['subcutaneous ixekizumab every two (Q2W) or four (Q4W) weeks, 40 mg adalimumab Q2W (active reference group), or placebo', 'placebo', 'Ixekizumab', 'ixekizumab Q4W', 'ixekizumab', 'adalimumab', 'interleukin-17A antagonist', 'ixekizumab Q2W']","['ixekizumab Q4W', 'treatment-emergent opportunistic infections, malignancies, or deaths occurred', 'proportion of patients achieving an ASAS40 response, a composite measure of clinical improvement in axial spondyloarthritis', 'radiographic axial spondyloarthritis signs and symptoms', 'Candida infection', 'serious infection']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0332139', 'cui_str': 'Established diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C0574960', 'cui_str': 'Sacroiliitis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003191', 'cui_str': 'Anti-Rheumatic Drugs'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",341.0,0.574053,"At week 16, compared with placebo (16 [18%] of 87), more patients achieved ASAS40 with ixekizumab Q2W (43 [52%] of 83; p<0·0001), ixekizumab Q4W (39 [48%] of 81; p<0·0001), and adalimumab (32 [36%] of 90; p=0·0053).","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands. Electronic address: mail@dvanderheijde.nl.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cheng-Chung Wei', 'Affiliation': 'Institute of Medicine, Chung Shan Medical University, Department of Internal Medicine, Chung Shan Medical University Hospital, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Maksymowych', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Sieper', 'Affiliation': 'Department of Rheumatology, Charite University Hospital, Berlin, Germany.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology and Clinical Immunology Center, Amsterdam, Netherlands; Zuyderland Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eswar', 'Initials': 'E', 'LastName': 'Krishnan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Pangallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Carlier', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)31946-9'] 1198,21157877,Modulation of subgenual anterior cingulate cortex activity with real-time neurofeedback.,"The advent of real-time neurofeedback techniques has allowed us to begin to map the controllability of sensory and cognitive and, more recently, affective centers in the brain. The subgenual anterior cingulate cortex (sACC) is thought to be involved in generation of affective states and has been implicated in psychopathology. In this study, we examined whether individuals could use real-time fMRI neurofeedback to modulate sACC activity. Following a localizer task used to identify an sACC region of interest, an experimental group of eight women participated in four scans: (1) a pretraining scan in which they were asked to decrease activity in the sACC without neurofeedback; (2) two training scans in which sACC neurofeedback was presented along with instructions to decrease sACC activity; and (3) a neurofeedback-free post-training scan. An additional nine women in a yoked feedback control group saw sACC activity from the participants in the experimental group. Activity in the sACC was significantly reduced during neurofeedback training in the experimental group, but not in the control group. This training effect in the experimental group, however, did not generalize to the neurofeedback-free post-training scan. A psychophysiological interaction analysis showed decreased correlation in the experimental group relative to the sham control group between activity in the sACC and the posterior cingulate cortex during neurofeedback training relative to neurofeedback-free scans. The finding that individuals can down-modulate the sACC shows that a primary emotion center in which functional abnormality has been strongly implicated in affective disorders can be controlled with the aid of neurofeedback.",2011,A psychophysiological interaction analysis showed decreased correlation in the experimental group relative to the sham control group between activity in the sACC and the posterior cingulate cortex during neurofeedback training relative to neurofeedback-free scans.,[],['neurofeedback-free post-training scan'],"['sACC activity', 'Activity']",[],"[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441633'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",8.0,0.0201326,A psychophysiological interaction analysis showed decreased correlation in the experimental group relative to the sham control group between activity in the sACC and the posterior cingulate cortex during neurofeedback training relative to neurofeedback-free scans.,"[{'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Hamilton', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, California 94305, USA. paul.hamilton@stanford.edu paul.hamilton@stanford.edu'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Glover', 'Affiliation': ''}, {'ForeName': 'Jung-Jiin', 'Initials': 'JJ', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Gotlib', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20997'] 1199,30746055,Improving neurocognitive functioning in schizophrenia by addition of cognitive remediation therapy to a standard treatment of metacognitive training.,"Cognitive dysfunctions are a common clinical feature of schizophrenia and represent important indicators of outcome among patients who are affected. Therefore, a randomized, controlled, monocentric, singleblind trial was carried out to compare two different rehabilitation strategies adopted for the restoration and recovery of cognitive functioning of residential patients with schizophrenia. A sample of 110 residential patients were selected and, during the experimental period, a group of 55 patients was treated with sets of domain-specific exercises (SRT+CRT), whereas an equal control group was treated with sets of nondomain- specific exercises (SRT+PBO) belonging to the Cogpack® software. The effects on the scores (between T0 and T1) of the variables treatment and time and of the interaction time X treatment were analyzed: for the total BACS, the main effect of the between-factors variable treatment is statistically significant (F=201.562 P=0.000), as well as the effect of the within-factors variable "" time "" (F=496.68 P=0.000).The interaction of these two factors is also statistically significant (F=299.594 P=0.000). The addition of cognitive remediation therapy (CRT) to a standard treatment of metacognitive training (MCT) resulted in a significant improvement in global neurocognitive functioning and has reported positive effects with regard to the strengthening of verbal and working memory, selective and sustained attention at T1. A relevant result is the statistically significance of "" time X treatment "" for all the tests administered: we can assume that the domain-specific cognitive training amplifies the effects of SRT, as the primary and secondary goals of the present study were achieved.",2018,"The addition of cognitive remediation therapy (CRT) to a standard treatment of metacognitive training (MCT) resulted in a significant improvement in global neurocognitive functioning and has reported positive effects with regard to the strengthening of verbal and working memory, selective and sustained attention at T1.","['residential patients with schizophrenia', 'patients who are affected', '110 residential patients were selected and, during the experimental period, a group of 55 patients was treated with']","['sets of domain-specific exercises (SRT+CRT), whereas an equal control group was treated with sets of nondomain- specific exercises (SRT+PBO) belonging to the Cogpack® software', 'metacognitive training (MCT', 'cognitive remediation therapy', 'metacognitive training', 'cognitive remediation therapy (CRT']",['global neurocognitive functioning'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",110.0,0.0317994,"The addition of cognitive remediation therapy (CRT) to a standard treatment of metacognitive training (MCT) resulted in a significant improvement in global neurocognitive functioning and has reported positive effects with regard to the strengthening of verbal and working memory, selective and sustained attention at T1.","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Caponnetto', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Maglia', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Auditore', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bocchieri', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Caruso', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DiPiazza', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Polosa', 'Affiliation': 'CTA Villa Chiara Psychiatric Rehabilitation and Research, University of Catania, Italy.'}]",Mental illness,['10.4081/mi.2018.7812'] 1200,31683467,Effects of dexmedetomidine on cerebral oxygen saturation and postoperative cognitive function in elderly patients undergoing minimally invasive coronary artery bypass surgery.,"OBJECTIVE This study aimed to investigate the effects of dexmedetomidine on cerebral oxygen saturation [Sct(O2)] and postoperative cognitive function in elderly patients undergoing minimally invasive coronary artery bypass graft surgery. METHODS Sixty elderly patients who received minimally invasive coronary artery bypass graft surgery were randomly equally divided into dexmedetomidine group (group D) and control group (group N). The patients in group D were pumped with 1 μg/kg dexmedetomidine for 15 min before incision, followed by continuous pumping at 0.3-0.5 μg/(kg·h) till the end of the operation. The patients in group N received same dose of normal saline during the operation. Sct(O2) was monitored at pre-induction (T0), post-induction (T1), 30 min (T2) after single-lung ventilation, and after surgery (T3). Mini-mental state examination (MMSE) was used to assess the cognitive function at 1 day before, 72 hour and 7 days after surgery. RESULTS Sct(O2) level in group D was significantly higher than that in group N at T2 (P < 0.05). Sct(O2) level was statistically lower at T2 than that at T0, T1 and T3 in the same group N (P < 0.05). At 72 h and 7d after operation, the incidence of cognitive dysfunction in group D was markedly lower than that in group N (P < 0.05), the MMSE score in group D was markedly higher than those in group N, but was significantly lower than that before surgery (P < 0.05). CONCLUSION Dexmedetomidine can alleviate the decrease of Sct(O2) during single-lung ventilation, improve postoperative cognitive function, and reduce the incidence of POCD in elderly patients with minimally invasive coronary artery bypass surgery.",2020,"Sct(O2) level was statistically lower at T2 than that at T0, T1 and T3 in the same group N (P < 0.05).","['Sixty elderly patients who received minimally invasive coronary artery bypass graft surgery', 'elderly patients undergoing minimally invasive coronary artery bypass surgery', 'elderly patients undergoing minimally invasive coronary artery bypass graft surgery', 'elderly patients with minimally invasive coronary artery bypass surgery']","['Dexmedetomidine', 'dexmedetomidine', 'Mini-mental state examination (MMSE', 'normal saline']","['incidence of cognitive dysfunction', 'Sct(O2', 'incidence of POCD', 'cognitive function', 'postoperative cognitive function', 'cerebral oxygen saturation [Sct(O2', 'MMSE score', 'Sct(O2) level', 'cerebral oxygen saturation and postoperative cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0237976,"Sct(O2) level was statistically lower at T2 than that at T0, T1 and T3 in the same group N (P < 0.05).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Imaging Center, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Lining', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Fulong', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190590'] 1201,31690402,Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT.,"BACKGROUND Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection. However, the use of prophylaxis has not been established in myeloma and may be associated with health-care-associated infections (HCAIs), such as Clostridium difficile . There is a need to assess the benefits and cost-effectiveness of the use of antibacterial prophylaxis against any risks in a double-blind, placebo-controlled, randomised clinical trial. OBJECTIVES To assess the risks, benefits and cost-effectiveness of prophylactic levofloxacin in newly diagnosed symptomatic myeloma patients. DESIGN Multicentre, randomised, double-blind, placebo-controlled trial. A central telephone randomisation service used a minimisation computer algorithm to allocate treatments in a 1 : 1 ratio. SETTING A total of 93 NHS hospitals throughout England, Northern Ireland and Wales. PARTICIPANTS A total of 977 patients with newly diagnosed symptomatic myeloma. INTERVENTION Patients were randomised to receive levofloxacin or placebo tablets for 12 weeks at the start of antimyeloma treatment. Treatment allocation was blinded and balanced by centre, estimated glomerular filtration rate and intention to give high-dose chemotherapy with autologous stem cell transplantation. Follow-up was at 4-week intervals up to 16 weeks, with a further follow-up at 1 year. MAIN OUTCOME MEASURES The primary outcome was to assess the number of febrile episodes (or deaths) in the first 12 weeks from randomisation. Secondary outcomes included number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond. RESULTS In total, 977 patients were randomised (levofloxacin, n  = 489; placebo, n  = 488). A total of 134 (27%) events (febrile episodes, n  = 119; deaths, n  = 15) occurred in the placebo arm and 95 (19%) events (febrile episodes, n  = 91; deaths, n  = 4) occurred in the levofloxacin arm; the hazard ratio for time to first event (febrile episode or death) within the first 12 weeks was 0.66 (95% confidence interval 0.51 to 0.86; p  = 0.002). Levofloxacin also reduced other infections (144 infections from 116 patients) compared with placebo (179 infections from 133 patients; p -trend of 0.06). There was no difference in new acquisitions of C. difficile , methicillin-resistant Staphylococcus aureus and extended-spectrum beta-lactamase Gram-negative organisms when assessed up to 16 weeks. Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use. With a median follow-up of 52 weeks, there was no significant difference in overall survival ( p  = 0.94). LIMITATIONS Short duration of prophylactic antibiotics and cost-effectiveness. CONCLUSIONS During the 12 weeks from new diagnosis, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and deaths without increasing HCAIs or carriage. Future work should aim to establish the optimal duration of antibiotic prophylaxis and should involve the laboratory investigation of immunity, inflammation and disease activity on stored samples funded by the TEAMM (Tackling Early Morbidity and Mortality in Myeloma) National Institute for Health Research Efficacy and Mechanism Evaluation grant (reference number 14/24/04). TRIAL REGISTRATION Current Controlled Trials ISRCTN51731976. FUNDING DETAILS This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 62. See the NIHR Journals Library website for further project information.",2019,"Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use.","['newly diagnosed symptomatic myeloma patients', 'A total of 977 patients with newly diagnosed symptomatic myeloma', 'Myeloma', 'A total of 93 NHS hospitals throughout England, Northern Ireland and Wales', 'newly diagnosed symptomatic myeloma', '977 patients were randomised']","['levofloxacin', 'Levofloxacin', 'levofloxacin or placebo tablets', 'levofloxacin, n \u2009=\u2009489; placebo', 'placebo', 'prophylactic levofloxacin', 'chemotherapy with autologous stem cell transplantation', 'Prophylactic levofloxacin']","['febrile episodes and deaths without increasing HCAIs or carriage', 'new acquisitions of C. difficile , methicillin-resistant Staphylococcus aureus and extended-spectrum beta-lactamase Gram-negative organisms', 'hazard ratio for time to first event (febrile episode or death', 'overall survival', 'quality-adjusted life-year gains', 'number of febrile episodes (or deaths', 'risks, benefits and cost-effectiveness', 'number of deaths and infection-related deaths, days in hospital, carriage and invasive infections, response to antimyeloma treatment and its relation to infection, quality of life and overall survival within the first 12 weeks and beyond']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0597979', 'cui_str': 'beta-Lactamase'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0029235', 'cui_str': 'Organism - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010187', 'cui_str': 'Cost Benefit'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",977.0,0.673029,"Levofloxacin produced slightly higher quality-adjusted life-year gains over 16 weeks, but had associated higher costs for health resource use.","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Institute of Infection and Immunity, St George's Hospital, University of London, London, UK.""}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, University College London Cancer Institute, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Low', 'Affiliation': 'Patient Advocacy, Myeloma UK, Edinburgh, UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23620'] 1202,32407608,"Liver function and prognosis, and influence of sacubitril/valsartan in patients with heart failure with reduced ejection fraction.","AIMS The prevalence of liver function abnormalities is common in patients with heart failure (HF) with reduced ejection fraction (HFrEF). We assessed the impact of liver function on prognosis and the effect of sacubitril/valsartan on measures of liver function in patients with HFrEF. METHODS AND RESULTS The PARADIGM-HF trial was a randomized, double-blind, active treatment-controlled trial. We included 8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a composite of HF hospitalization and cardiovascular (CV) death. At screening, 11.6% of study patients had total bilirubin above the upper limit of normal (20.5 μmol/L) and 9.2% had ALP above the upper limit of normal (123 IU/L). Although ALP and albumin were associated with an increased risk of outcomes, among conventional test of liver function, total bilirubin was the strongest predictor for the primary endpoint [hazard ratio (HR) 1.10; 95% confidence interval (CI) 1.04-1.15; P < 0.001], HF hospitalization (HR 1.14; 95% CI 1.07-1.22; P < 0.001); CV death (HR 1.07; 95% CI 1.00-1.14; P = 0.040), and all-cause death (HR 1.08; 95% CI 1.02-1.14; P = 0.009). All conventional measures of liver function were significantly improved in the sacubitril/valsartan group compared with the enalapril group after randomization (between-group reduction: total bilirubin 2.4%, 95% CI 0.7-4.2%, P = 0.007; aspartate aminotransferase 7.9%, 95% CI 6.7-9.0%, P < 0.001; alanine aminotransferase 7.7%; 95% CI 6.2-9.3%, P < 0.001; ALP 5.4%, 95% CI 4.4-6.4%, P < 0.001). CONCLUSION Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF. Sacubitril/valsartan improved measures of liver function compared with enalapril.",2020,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"['patients with HFrEF', 'patients with HFrEF enrolled in PARADIGM-HF', 'patients with heart failure with reduced ejection fraction', '8232 HFrEF patients with available measures of liver function, including transaminases, alkaline phosphatase (ALP) and bilirubin; the primary endpoint was a', 'patients with heart failure (HF) with reduced ejection fraction (HFrEF']","['enalapril', 'sacubitril/valsartan', 'Sacubitril/valsartan']","['composite of HF hospitalization and cardiovascular (CV) death', 'HF hospitalization', 'total bilirubin', 'Total bilirubin', 'CV death', 'CV death or HF hospitalization and all-cause mortality', 'liver function', 'liver function, total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1285893', 'cui_str': 'Measure of liver'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",8232.0,0.350391,Total bilirubin was a significant and independent predictor of CV death or HF hospitalization and all-cause mortality in patients with HFrEF enrolled in PARADIGM-HF.,"[{'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Minamisawa', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover, NJ, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Zucker', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",European journal of heart failure,['10.1002/ejhf.1853'] 1203,30193936,Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps.,"BACKGROUND An estimated 7% of patients with asthma have chronic rhinosinusitis with nasal polyps (CRSwNP), and more than 80% have at least some radiographic evidence of sinonasal inflammation. Aspirin sensitivity is strongly associated with elevated blood eosinophil levels and increased asthma severity. Intravenous (IV) reslizumab has been shown to improve asthma control in patients with nasal polyps. OBJECTIVE These post hoc analyses of pooled data from 2 BREATH phase 3 clinical trials, studies 1 and 2 (NCT01287039 and NCT01285323), examined asthma-related outcomes in patients with comorbid, self-reported CRSwNP with and without aspirin sensitivity. METHODS Patients aged 12-75 years with elevated blood eosinophils (≥400 cells/μL) and inadequately controlled asthma were randomized to receive placebo or reslizumab (3 mg/kg IV) every 4 weeks for 52 weeks. Patients continued their background asthma maintenance therapy during the study. Information regarding the presence of CRSwNP was obtained through patient-reported medical history. RESULTS Add-on reslizumab treatment reduced the frequency of clinical asthma exacerbations by 83% versus placebo among patients with CRSwNP. Among patients with and without aspirin sensitivity, reductions of 79% and 84%, respectively, were observed. Patients with CRSwNP (with and without aspirin sensitivity) treated with reslizumab add-on therapy also had significant improvements in lung function, as measured by forced expiratory volume in 1 second, compared with placebo. Among patients with CRSwNP, reslizumab was also associated with improvements in patient-reported asthma control and asthma quality of life. CONCLUSIONS Patients with eosinophilic asthma and self-reported CRSwNP, with and without aspirin sensitivity, are highly responsive to treatment with reslizumab for asthma-related outcomes. These findings suggest that prospective investigation of reslizumab in this patient population is warranted.",2019,"Among patients with CRSwNP, reslizumab was also associated with improvements in patient-reported asthma control and asthma quality of life. ","['patients with asthma have chronic rhinosinusitis with nasal polyps (CRSwNP', 'Patients aged 12-75 years with elevated blood eosinophils (≥400 cells/μL) and inadequately controlled asthma', 'patients with comorbid, self-reported CRSwNP with and without aspirin sensitivity', 'Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps', 'patients with CRSwNP', 'Patients with CRSwNP (with and without aspirin sensitivity) treated with', 'patients with nasal polyps']","['Intravenous (IV) reslizumab', 'placebo', 'placebo or reslizumab', 'reslizumab', 'Reslizumab']","['Asthma Outcomes', 'elevated blood eosinophil levels', 'patient-reported asthma control and asthma quality of life', 'frequency of clinical asthma exacerbations', 'Aspirin sensitivity', 'lung function', 'forced expiratory volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.118678,"Among patients with CRSwNP, reslizumab was also associated with improvements in patient-reported asthma control and asthma quality of life. ","[{'ForeName': 'Steven F', 'Initials': 'SF', 'LastName': 'Weinstein', 'Affiliation': 'Allergy and Asthma Specialists Medical Group and Research Center, Huntington Beach, Calif. Electronic address: sfw@ocallergy.com.'}, {'ForeName': 'Rohit K', 'Initials': 'RK', 'LastName': 'Katial', 'Affiliation': 'Division of Allergy and Immunology, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bardin', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre and University, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Department, Mainz University Hospital, Mainz, Germany.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Global Respiratory R&D, Teva Branded Pharmaceutical Products R&D Inc., Malvern, Pa.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Garin', 'Affiliation': 'Global Respiratory R&D, Teva Branded Pharmaceutical Products R&D Inc., Malvern, Pa.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Bateman', 'Affiliation': 'Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Flavia C L', 'Initials': 'FCL', 'LastName': 'Hoyte', 'Affiliation': 'Division of Allergy and Immunology, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Germinaro', 'Affiliation': 'Global Respiratory R&D, Teva Branded Pharmaceutical Products R&D Inc., Malvern, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.08.021'] 1204,31089282,Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial.,"This study evaluates the physical and psychosocial effects of an inpatient exercise program for children and adolescents undergoing hematopoietic stem cell transplantation (HSCT). Participants (n = 70) were randomized to an exercise intervention (IG: resistance, endurance, and flexibility training) or a non-exercise control group (CG: mental and relaxation training). Pre- (prior hospital admission; T0) and post- (day of discharge; T1) measurements included maximal isometric knee extension strength (KES; strain gauge force transducer), hand grip strength (HGS; JAMAR dynamometer), distance walked in 6 min (6MWD; 6-minute walk test), quality of life (QoL; KINDL-R) and medical parameters. Fifty-seven patients (IG: n = 28; 11.0 (5-17) years; CG: n = 29; 12.0 (6-18) years) completed the study. During hospitalization the IG and CG attended on average 3.1 (2-4) or 2.9 (0.3-4) training sessions weekly. KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG. Pre- to post-changes in 6MWD and HGS differed significantly between groups (p < 0.05). QoL declined in both groups (p < 0.05). Our results indicate that a moderate exercise program is feasible and might counteract a treatment-associated decline of physical performance.",2019,"KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG.","['Participants (n\u2009=\u200970', 'children and adolescents undergoing hematopoietic stem cell transplantation (HSCT', 'Fifty-seven patients (IG: n\u2009=\u200928; 11.0 (5-17) years; CG: n\u2009=\u200929; 12.0 (6-18) years) completed the study', 'pediatric stem cell transplantation']","['Pre', 'inpatient exercise program', 'exercise therapy', 'exercise intervention (IG: resistance, endurance, and flexibility training) or a non-exercise control group (CG: mental and relaxation training', 'moderate exercise program']","['KES, 6MWD, and HGS', 'Psychophysical effects', 'maximal isometric knee extension strength (KES; strain gauge force transducer), hand grip strength (HGS; JAMAR dynamometer), distance walked in 6\u2009min (6MWD; 6-minute walk test), quality of life (QoL; KINDL-R) and medical parameters', 'QoL', '6MWD and HGS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0040661', 'cui_str': 'Transducers'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0397428,"KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Senn-Malashonak', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Hemostaseology, Goethe University Hospital, Frankfurt am Main, Germany. anna.senn-malashonak@kgu.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wallek', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Hemostaseology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenhagen', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Department for Stem Cell Transplantation and Immunology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",Bone marrow transplantation,['10.1038/s41409-019-0535-z'] 1205,31346609,Low Hepatitis C Reinfection Following Direct-acting Antiviral Therapy Among People Who Inject Drugs on Opioid Agonist Therapy.,"BACKGROUND Direct-acting antiviral (DAA) therapy is highly effective in people who inject drugs (PWID); however, rates, specific injection behaviors, and social determinants associated with hepatitis C virus (HCV) reinfection following DAA therapy among PWID on opioid agonist therapy (OAT) are poorly understood. METHODS PREVAIL was a randomized controlled trial that assessed models of HCV care for 150 PWID on OAT. Those who achieved sustained virologic response (SVR) (n = 141; 94%) were eligible for this extension study. Interviews and assessments of recurrent HCV viremia occurred at 6-month intervals for up to 24 months following PREVAIL. We used survival analysis to analyze variables associated with time to reinfection. RESULTS Of 141 who achieved SVR, 114 had a least 1 visit in the extension study (62% male; mean age, 52 years). Injection drug use (IDU) was reported by 19% (n = 22) in the extension study. HCV reinfection was observed in 3 participants. Over 246 person-years of follow-up, the incidence of reinfection was 1.22/100 person-years (95% CI, 0.25-3.57). All reinfections occurred among participants reporting ongoing IDU. The incidence of reinfection in participants reporting ongoing IDU (41 person-years of follow-up) was 7.4/100 person-years (95% CI, 1.5-21.6). Reinfection was associated with reporting ongoing IDU in the follow-up period (P < .001), a lack confidence in the ability to avoid contracting HCV (P < .001), homelessness (P = .002), and living with a PWID (P = .007). CONCLUSIONS HCV reinfection was low overall, but more common among people with ongoing IDU following DAA therapy on OAT, as well as those who were not confident in the ability to avoid contracting HCV, homeless, or living with a PWID. Interventions to mediate these risk factors following HCV therapy are warranted.",2020,"Reinfection was associated with reporting ongoing IDU in the follow-up period (p<.001), a lack confidence in the ability to avoid contracting HCV (p<.001), homelessness (p=.002), and living with a PWID (p=.007). ","['Those who achieved SVR (n=141; 94%) were eligible for this extension study', 'People', 'Of 141 who achieved SVR', ' 114 had a least one visit in the extension study (62% male, mean age 52']","['HCV care for 150 PWID on OAT', 'Direct acting antiviral (DAA) therapy', 'Direct-Acting Antiviral Therapy', 'HCV therapy']","['recurrent HCV viremia', 'HCV reinfection', 'Low Hepatitis C Reinfection', 'incidence of reinfection', 'Reinfection']","[{'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.0921077,"Reinfection was associated with reporting ongoing IDU in the follow-up period (p<.001), a lack confidence in the ability to avoid contracting HCV (p<.001), homelessness (p=.002), and living with a PWID (p=.007). ","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Akiyama', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lipsey', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University, South Carolina.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Agyemang', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Brianna L', 'Initials': 'BL', 'LastName': 'Norton', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hidalgo', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Kiara', 'Initials': 'K', 'LastName': 'Lora', 'Affiliation': 'Divisions of General Internal Medicine, Bronx, New York.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Department of Medicine, University of South Carolina School of Medicine-Greenville, Greenville.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz693'] 1206,30690595,Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome.,"OBJECTIVE To compare the effectiveness of lung lavage with surfactant vs. bolus surfactant treatment in meconium aspiration syndrome (MAS). PATIENTS AND METHODS This randomized controlled trial included newborns ventilated with MAS. In lavage group (n = 17) 30 ml/kg of diluted porcine surfactant was instilled into the lung. In bolus group (n = 16) porcine surfactant (100 mg/kg) was administered as bolus. Respiratory outcomes and mortality were compared between groups. RESULTS Duration of respiratory support was found to be similar between lavage and bolus groups (3 vs. 3.5 days, p = 0.36). Death or requirement for extracorporeal membrane oxygenation (ECMO) was 12% vs. 6%; respectively (RR: 2, 95% CI 0.16-24.48; p = 1.0). Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups. CONCLUSION Lung lavage did not show any advantage over bolus therapy on duration of respiratory support. The incidence of pneumothorax and surfactant re-administration decreased nonsignificantly in lavage group. CLINICAL TRIAL REGISTRATION We registered the trial to ClinicalTrials.gov (http://clinicaltrials.gov) under identifier NCT02041546. REGISTRY NAME Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome.",2019,"Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups. ","['Meconium Aspiration Syndrome', 'newborns ventilated with MAS', 'meconium aspiration syndrome (MAS']","['lung lavage with surfactant vs. bolus surfactant treatment', 'Lung Lavage with Dilute Surfactant vs. Bolus Surfactant', 'Dilute Poractant Alfa', 'porcine surfactant', 'diluted porcine surfactant']","['Death or requirement for extracorporeal membrane oxygenation (ECMO', 'duration of respiratory support', 'Duration of respiratory support', 'Respiratory outcomes and mortality', 'Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement', 'incidence of pneumothorax and surfactant re-administration']","[{'cui': 'C0025048', 'cui_str': 'Meconium Aspiration Syndrome'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0771648', 'cui_str': 'Poractant alfa'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0019541', 'cui_str': 'High-Frequency Ventilation'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",,0.174174,"Duration of oxygen therapy, high-frequency ventilation or inhaled nitric oxide requirement did not differ among the groups. ","[{'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Arayici', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Sari', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Kadioglu Simsek', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Erbu', 'Initials': 'E', 'LastName': 'Yarci', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Alyamac Dizdar', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uras', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Fuat Emre', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}, {'ForeName': 'Serife Suna', 'Initials': 'SS', 'LastName': 'Oguz', 'Affiliation': 'Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy081'] 1207,30658933,"Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial.","BACKGROUND Human papillomavirus (HPV) testing on self-collected samples is a potential alternative to HPV testing on clinician-collected samples, but non-inferiority of its clinical accuracy remains to be assessed in the regular screening population. The IMPROVE study was done to evaluate the clinical accuracy of primary HPV testing on self-collected samples within an organised screening setting. METHODS In this randomised, non-inferiority trial, women aged 29-61 years were invited to participate in the study as part of their regular screening invitation in the Netherlands. Women who provided informed consent were randomly allocated (1:1, with a block size of ten stratified by age) to one of two groups: a self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands); or a clinician-based sampling group, in which samples were collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV). All samples were tested for HPV using the clinically validated GP5+/6+ PCR enzyme immunoassay (Labo Biomedical Products BV, Rijswijk, Netherlands). HPV-positive women in both groups were retested with the other collection method and triaged by cytology and repeat cytology in accordance with current Dutch screening guidelines. Primary endpoints were detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+). Non-inferiority of HPV testing on self-collected versus clinician-collected samples was evaluated against a margin of 90% for the relative sensitivity and 98% for the relative specificity. This study is registered at the Dutch Trial register (NTR5078) and has been completed. FINDINGS Of the 187 473 women invited to participate, 8212 were randomly allocated to the self-sampling group and 8198 to the clinician-based sampling group. After exclusion of women who met the exclusion criteria or who did not return their sample, 7643 women were included in the self-sampling group and 6282 in the clinician-based sampling group. 569 (7·4%) self-collected samples and 451 (7·2%) clinician-collected samples tested positive for HPV (relative risk 1·04 [95% CI 0·92-1·17]). Median follow-up duration for HPV-positive women was 20 months (IQR 17-22). The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96 [0·90-1·03]; relative specificity 1·00 [0·99-1·01]). For the CIN3+ endpoint, relative sensitivity was 0·99 (0·91-1·08) and relative specificity was 1·00 (0·99-1·01). INTERPRETATION HPV testing done with a clinically validated PCR-based assay had similar accuracy on self-collected and clinician-collected samples in terms of the detection of CIN2+ or CIN3+ lesions. These findings suggest that HPV self-sampling could be used as a primary screening method in routine screening. FUNDING Ministry of Health, Welfare, and Sport (Netherlands), and the European Commission.",2019,The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96,"['cervical intraepithelial neoplasia of grade 2 or worse', 'Of the 187\u2008473 women invited to participate', 'women who met the exclusion criteria or who did not return their sample, 7643 women were included in the self-sampling group and 6282 in the clinician-based sampling group', 'Women who provided informed consent', 'women aged 29-61 years were invited to participate in the study as part of their regular screening invitation in the Netherlands']","['self-sampling group and 8198 to the clinician-based sampling group', 'self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV, Oss, Netherlands); or a clinician-based sampling group, in which samples were collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV', 'human papillomavirus testing on self-collected versus clinician-collected samples']","['detection of cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) and grade 3 or worse (CIN3', 'CIN2+ sensitivity and specificity of HPV testing']","[{'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0025080', 'cui_str': 'Medical Devices'}, {'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",7643.0,0.17207,The CIN2+ sensitivity and specificity of HPV testing did not differ between self-sampling and clinician-based sampling (relative sensitivity 0·96,"[{'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Polman', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Renée M F', 'Initials': 'RMF', 'LastName': 'Ebisch', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Daniëlle A M', 'Initials': 'DAM', 'LastName': 'Heideman', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Willem J G', 'Initials': 'WJG', 'LastName': 'Melchers', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Ruud L M', 'Initials': 'RLM', 'LastName': 'Bekkers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Anco C', 'Initials': 'AC', 'LastName': 'Molijn', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Chris J L M', 'Initials': 'CJLM', 'LastName': 'Meijer', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Wim G V', 'Initials': 'WGV', 'LastName': 'Quint', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Peter J F', 'Initials': 'PJF', 'LastName': 'Snijders', 'Affiliation': 'Cancer Centre Amsterdam, Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Leon F A G', 'Initials': 'LFAG', 'LastName': 'Massuger', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Folkert J', 'Initials': 'FJ', 'LastName': 'van Kemenade', 'Affiliation': 'Department of Pathology, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health, Amsterdam, Netherlands. Electronic address: h.berkhof@vumc.nl.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30763-0'] 1208,30673120,Pregabalin for neuropathic pain in adults.,"BACKGROUND This review updates part of an earlier Cochrane Review titled ""Pregabalin for acute and chronic pain in adults"", and considers only neuropathic pain (pain from damage to nervous tissue). Antiepileptic drugs have long been used in pain management. Pregabalin is an antiepileptic drug used in management of chronic pain conditions. OBJECTIVES To assess the analgesic efficacy and adverse effects of pregabalin for chronic neuropathic pain in adults. SEARCH METHODS We searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from January 2009 to April 2018, online clinical trials registries, and reference lists. SELECTION CRITERIA We included randomised, double-blind trials of two weeks' duration or longer, comparing pregabalin (any route of administration) with placebo or another active treatment for neuropathic pain, with participant-reported pain assessment. DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed trial quality and biases. Primary outcomes were: at least 30% pain intensity reduction over baseline; much or very much improved on the Patient Global Impression of Change (PGIC) Scale (moderate benefit); at least 50% pain intensity reduction; or very much improved on PGIC (substantial benefit). We calculated risk ratio (RR) and number needed to treat for an additional beneficial (NNTB) or harmful outcome (NNTH). We assessed the quality of the evidence using GRADE. MAIN RESULTS We included 45 studies lasting 2 to 16 weeks, with 11,906 participants - 68% from 31 new studies. Oral pregabalin doses of 150 mg, 300 mg, and 600 mg daily were compared with placebo. Postherpetic neuralgia, painful diabetic neuropathy, and mixed neuropathic pain predominated (85% of participants). High risk of bias was due mainly to small study size (nine studies), but many studies had unclear risk of bias, mainly due to incomplete outcome data, size, and allocation concealment.Postherpetic neuralgia: More participants had at least 30% pain intensity reduction with pregabalin 300 mg than with placebo (50% vs 25%; RR 2.1 (95% confidence interval (CI) 1.6 to 2.6); NNTB 3.9 (3.0 to 5.6); 3 studies, 589 participants, moderate-quality evidence), and more had at least 50% pain intensity reduction (32% vs 13%; RR 2.5 (95% CI 1.9 to 3.4); NNTB 5.3 (3.9 to 8.1); 4 studies, 713 participants, moderate-quality evidence). More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (62% vs 24%; RR 2.5 (95% CI 2.0 to 3.2); NNTB 2.7 (2.2 to 3.7); 3 studies, 537 participants, moderate-quality evidence), and more had at least 50% pain intensity reduction (41% vs 15%; RR 2.7 (95% CI 2.0 to 3.5); NNTB 3.9 (3.1 to 5.5); 4 studies, 732 participants, moderate-quality evidence). Somnolence and dizziness were more common with pregabalin than with placebo (moderate-quality evidence): somnolence 300 mg 16% versus 5.5%, 600 mg 25% versus 5.8%; dizziness 300 mg 29% versus 8.1%, 600 mg 35% versus 8.8%.Painful diabetic neuropathy: More participants had at least 30% pain intensity reduction with pregabalin 300 mg than with placebo (47% vs 42%; RR 1.1 (95% CI 1.01 to 1.2); NNTB 22 (12 to 200); 8 studies, 2320 participants, moderate-quality evidence), more had at least 50% pain intensity reduction (31% vs 24%; RR 1.3 (95% CI 1.2 to 1.5); NNTB 22 (12 to 200); 11 studies, 2931 participants, moderate-quality evidence), and more had PGIC much or very much improved (51% vs 30%; RR 1.8 (95% CI 1.5 to 2.0); NNTB 4.9 (3.8 to 6.9); 5 studies, 1050 participants, moderate-quality evidence). More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (63% vs 52%; RR 1.2 (95% CI 1.04 to 1.4); NNTB 9.6 (5.5 to 41); 2 studies, 611 participants, low-quality evidence), and more had at least 50% pain intensity reduction (41% vs 28%; RR 1.4 (95% CI 1.2 to 1.7); NNTB 7.8 (5.4 to 14); 5 studies, 1015 participants, low-quality evidence). Somnolence and dizziness were more common with pregabalin than with placebo (moderate-quality evidence): somnolence 300 mg 11% versus 3.1%, 600 mg 15% versus 4.5%; dizziness 300 mg 13% versus 3.8%, 600 mg 22% versus 4.4%.Mixed or unclassified post-traumatic neuropathic pain: More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (48% vs 36%; RR 1.2 (1.1 to 1.4); NNTB 8.2 (5.7 to 15); 4 studies, 1367 participants, low-quality evidence), and more had at least 50% pain intensity reduction (34% vs 20%; RR 1.5 (1.2 to 1.9); NNTB 7.2 (5.4 to 11); 4 studies, 1367 participants, moderate-quality evidence). Somnolence (12% vs 3.9%) and dizziness (23% vs 6.2%) were more common with pregabalin.Central neuropathic pain: More participants had at least 30% pain intensity reduction with pregabalin 600 mg than with placebo (44% vs 28%; RR 1.6 (1.3 to 2.0); NNTB 5.9 (4.1 to 11); 3 studies, 562 participants, low-quality evidence) and at least 50% pain intensity reduction (26% vs 15%; RR 1.7 (1.2 to 2.3); NNTB 9.8 (6.0 to 28); 3 studies, 562 participants, low-quality evidence). Somnolence (32% vs 11%) and dizziness (23% vs 8.6%) were more common with pregabalin.Other neuropathic pain conditions: Studies show no evidence of benefit for 600 mg pregabalin in HIV neuropathy (2 studies, 674 participants, moderate-quality evidence) and limited evidence of benefit in neuropathic back pain or sciatica, neuropathic cancer pain, or polyneuropathy.Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence). AUTHORS' CONCLUSIONS Evidence shows efficacy of pregabalin in postherpetic neuralgia, painful diabetic neuralgia, and mixed or unclassified post-traumatic neuropathic pain, and absence of efficacy in HIV neuropathy; evidence of efficacy in central neuropathic pain is inadequate. Some people will derive substantial benefit with pregabalin; more will have moderate benefit, but many will have no benefit or will discontinue treatment. There were no substantial changes since the 2009 review.",2019,"Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence). ","['neuropathic pain in adults', '45 studies lasting 2 to 16 weeks, with 11,906 participants - 68% from 31 new studies', 'chronic neuropathic pain in adults', '674 participants, moderate-quality evidence', 'Central neuropathic pain']","['Pregabalin', 'Oral pregabalin', 'pregabalin', 'placebo']","['moderate-quality evidence', 'Patient Global Impression of Change (PGIC) Scale', '8.8%.Painful diabetic neuropathy', 'calculated risk ratio (RR) and number needed to treat for an additional beneficial (NNTB) or harmful outcome (NNTH', 'Serious adverse events, all conditions: Serious adverse events', 'traumatic neuropathic pain', 'neuropathic back pain or sciatica, neuropathic cancer pain, or polyneuropathy', 'Postherpetic neuralgia', 'Postherpetic neuralgia, painful diabetic neuropathy, and mixed neuropathic pain', 'Somnolence and dizziness', 'Somnolence', 'analgesic efficacy and adverse effects', 'pain intensity reduction', 'dizziness', 'somnolence']","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia (disorder)'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",11906.0,0.623031,"Serious adverse events, all conditions: Serious adverse events were no more common with placebo than with pregabalin 300 mg (3.1% vs 2.6%; RR 1.2 (95% CI 0.8 to 1.7); 17 studies, 4112 participants, high-quality evidence) or pregabalin 600 mg (3.4% vs 3.4%; RR 1.1 (95% CI 0.8 to 1.5); 16 studies, 3995 participants, high-quality evidence). ","[{'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Derry', 'Affiliation': 'Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LE.'}, {'ForeName': 'Rae Frances', 'Initials': 'RF', 'LastName': 'Bell', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Straube', 'Affiliation': ''}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Wiffen', 'Affiliation': ''}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Aldington', 'Affiliation': ''}, {'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Moore', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD007076.pub3'] 1209,32407810,Mifepristone-misoprostol versus misoprostol-alone regimen for medication abortion at ≥24 weeks' gestation.,"OBJECTIVE To compare time from misoprostol initiation to fetal expulsion for mifepristone-misoprostol versus misoprostol-alone regimens of medication abortion performed at ≥24 weeks' gestation. STUDY DESIGN We conducted a retrospective study of medication abortion performed at ≥24 weeks' gestation between May 2016 and January 2018 at one site, comparing outcomes of patients receiving mifepristone-misoprostol versus misoprostol alone during two periods. All patients received feticidal injection and laminaria; the mifepristone-misoprostol group also received mifepristone 200 mg orally around the time of initial laminaria. Beginning 24-72 h later (depending on cervical assessment), both groups received misoprostol buccally every two hours. RESULTS Analyses included 257 patients in the mifepristone-misoprostol group and 152 patients in the misoprostol-alone group. Median time from misoprostol initiation to fetal expulsion was similar between groups (4.8 h vs. 4.9 h; p = 0.43). Patients in the mifepristone-misoprostol group received less misoprostol overall (median [IQR]: 800 mcg [800-1200 mcg] vs. 1200 mcg [800-1600 mcg]; p < 0.01) and fewer patients received a second round of laminaria (n = 56, 22% vs. n = 58, 33%; p < 0.01) than the misoprostol-alone group. Seven patients (2%) were transferred to a hospital for complications; this proportion did not vary by regimen. CONCLUSIONS Addition of mifepristone was not associated with a reduction in induction interval at ≥24 weeks. However, patients in the mifepristone-misoprostol group received a lower total dose of misoprostol and were less likely to require two days of laminaria. The clinical significance of these differences is unclear, but may have implications for patient experience. Both regimens had low rates of complications. IMPLICATIONS A randomized controlled trial comparing the mifepristone-misoprostol and misoprostol-alone regimens at ≥24 weeks is needed, as is evidence on patient perspectives on these regimens. Given the existing evidence, either regimen is reasonable.",2020,"Both regimens had low rates of complications. ","['257 patients in the', ""medication abortion at ≥24 weeks' gestation"", 'group and 152 patients in the misoprostol-alone group']","['Mifepristone-misoprostol', 'misoprostol-alone', 'mifepristone-misoprostol versus misoprostol', 'mifepristone', 'misoprostol-alone group', 'misoprostol', 'mifepristone-misoprostol', 'misoprostol-alone regimen', 'mifepristone-misoprostol and misoprostol-alone regimens']","['Median time from misoprostol initiation to fetal expulsion', 'low rates of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.139039,"Both regimens had low rates of complications. ","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Wingo', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA. Electronic address: erin.wingo@ucsf.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raifman', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Landau', 'Affiliation': ""Southwestern Women's Options, 522 Lomas Blvd NE, Albuquerque, NM 87102, USA.""}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Sella', 'Affiliation': ""Southwestern Women's Options, 522 Lomas Blvd NE, Albuquerque, NM 87102, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, 1330 Broadway Suite 1100, Oakland, CA 94612, USA.'}]",Contraception,['10.1016/j.contraception.2020.05.001'] 1210,29655257,Neuroplasticity and network connectivity of the motor cortex following stroke: A transcranial direct current stimulation study.,"Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has potential for clinical utility in neurorehabilitation. However, recent evidence indicates that the responses to tDCS are highly variable. This study investigated whether electroencephalographic (EEG) measures of functional connectivity of the target network were associated with the response to ipsilesional anodal tDCS in stroke survivors. Ten chronic stroke patients attended two experimental sessions in a randomized cross-over trial and received anodal or sham tDCS. Single-pulse transcranial magnetic stimulation was used to quantify change in corticospinal excitability following tDCS. At the beginning of each session, functional connectivity was estimated using the debiased-weighted phase lag index from EEG recordings at rest. Magnetic resonance imaging identified lesion location and lesion volume. Partial least squares regression identified models of connectivity which maximally accounted for variance in anodal tDCS responses. Stronger connectivity of a network with a seed approximating the stimulated ipsilesional motor cortex, and clusters of electrodes approximating the ipsilesional parietal cortex and contralesional frontotemporal cortex in the alpha band (8-13 Hz) was strongly associated with a greater increase of corticospinal excitability following anodal tDCS. This association was not observed following sham stimulation. Addition of a structural measure(s) of injury (lesion volume) provided an improved model fit for connectivity between the seed electrode and ipsilesional parietal cortex, but not the contralesional frontotemporal cortex. TDCS has potential to greatly assist stroke rehabilitation and functional connectivity appears a robust and specific biomarker of response which may assist clinical translation of this therapy.",2018,Ten chronic stroke patients attended two experimental sessions in a randomized cross-over trial and received anodal or sham tDCS.,"['Ten chronic stroke patients', 'stroke', 'stroke survivors']","['electroencephalographic (EEG', 'TDCS', 'anodal or sham tDCS', 'Single-pulse transcranial magnetic stimulation', 'Transcranial direct current stimulation (tDCS']","['Neuroplasticity and network connectivity', 'corticospinal excitability', 'functional connectivity']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}]","[{'cui': 'C0027880', 'cui_str': 'Neural Plasticity'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0671165,Ten chronic stroke patients attended two experimental sessions in a randomized cross-over trial and received anodal or sham tDCS.,"[{'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Hordacre', 'Affiliation': 'The Sansom Institute for Health Research, School of Health Sciences, The University of South Australia, Adelaide, 5001, Australia.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Moezzi', 'Affiliation': 'The Robinson Research Institute, Adelaide Medical School, The University of Adelaide, Adelaide, 5005, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Ridding', 'Affiliation': 'The Robinson Research Institute, Adelaide Medical School, The University of Adelaide, Adelaide, 5005, Australia.'}]",Human brain mapping,['10.1002/hbm.24079'] 1211,30692052,Long-term effect of thymectomy plus prednisone versus prednisone alone in patients with non-thymomatous myasthenia gravis: 2-year extension of the MGTX randomised trial.,"BACKGROUND The Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) showed that thymectomy combined with prednisone was superior to prednisone alone in improving clinical status as measured by the Quantitative Myasthenia Gravis (QMG) score in patients with generalised non-thymomatous myasthenia gravis at 3 years. We investigated the long-term effects of thymectomy up to 5 years on clinical status, medication requirements, and adverse events. METHODS We did a rater-blinded 2-year extension study at 36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate. MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease, and were on optimal anticholinesterase therapy with or without oral corticosteroids. In MGTX, patients were randomly assigned (1:1) to either thymectomy plus prednisone or prednisone alone. All patients in both groups received oral prednisone at doses titrated up to 100 mg on alternate days until they achieved minimal manifestation status. The primary endpoints of the extension phase were the time-weighted means of the QMG score and alternate-day prednisone dose from month 0 to month 60. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00294658. It is closed to new participants, with follow-up completed. FINDINGS Of the 111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group). 50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group. At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87] vs 9·34 [5·08]; p=0·0007) and mean alternate-day prednisone doses (24 mg [SD 21] vs 48 mg [29]; p=0·0002) than did those in the prednisone alone group. 14 (42%) of 33 patients in the prednisone group, and 12 (34%) of 35 in the thymectomy plus prednisone group, had at least one adverse event by month 60. No treatment-related deaths were reported during the extension phase. INTERPRETATION At 5 years, thymectomy plus prednisone continues to confer benefits in patients with generalised non-thymomatous myasthenia gravis compared with prednisone alone. Although caution is appropriate when generalising our findings because of the small sample size of our study, they nevertheless provide further support for the benefits of thymectomy in patients with generalised non-thymomatous myasthenia gravis. FUNDING National Institutes of Health, National Institute of Neurological Disorders and Stroke.",2019,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","['patients with generalised non-thymomatous myasthenia gravis at 3 years', '36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate', 'patients with non-thymomatous myasthenia gravis', 'patients with generalised non-thymomatous myasthenia gravis', ""MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease"", 'Non-Thymomatous Myasthenia Gravis Patients Receiving', '111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group', '50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group']","['anticholinesterase therapy with or without oral corticosteroids', 'thymectomy', 'Prednisone (MGTX', 'thymectomy plus prednisone', 'prednisone alone', 'thymectomy combined with prednisone', 'thymectomy plus prednisone or prednisone alone', 'prednisone', 'oral prednisone']","['time-weighted means of the QMG score', 'time-weighted mean QMG scores', 'Quantitative Myasthenia Gravis (QMG) score', 'clinical status, medication requirements, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013615', 'cui_str': 'Edrophonium'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0430810', 'cui_str': 'Repetitive nerve stimulation (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0947912'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3540712', 'cui_str': 'Anticholinesterases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.191306,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","[{'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA. Electronic address: gilwolfe@buffalo.edu.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Marx', 'Affiliation': 'Institute of Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'Institute of Pathology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mazia', 'Affiliation': 'Department of Neurology, University of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'Division of Neurology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'J Gabriel', 'Initials': 'JG', 'LastName': 'Cea', 'Affiliation': 'Department of Neurology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'Department of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'Department of Neurology, Johanes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'Department of Neurology, University of Rochester Medical Centre, Rochester, NY, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Neurology, Mental Health and Sensory Organs, University of Rome Sapienza, Rome, Italy.'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'Department of Neurology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'Department of Neurology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'Department of Neurology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Centre of Texas, Houston, TX, USA.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'Walton Centre for Neurology and Neurosurgery, Liverpool, UK.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'Unit of Neurology, Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Neurology, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Department of Neurology, Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'Department of Neurology, University of Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'Department of Neurology, Georgia Regents University, Augusta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'Department of Neurology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Neurology, University of Texas Health Science Centre, San Antonio, TX, USA.'}, {'ForeName': 'Jan J G M', 'Initials': 'JJGM', 'LastName': 'Verschuuren', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'Department of Neurology, Duke University Medical Centre, Durham, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology, Ohio State University Wexner Medical Centre, Columbus, OH, USA.'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'Department of Neurology, Universidade Federal do Parana, Curitiba, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Centre, Kansas City, KS, USA.'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'Department of Neurological Sciences, University of Vermont College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'Department of Neurology, University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Silvestri', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'Division of Extramural Research, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Jaretzki', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newsom-Davis', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30392-2'] 1212,30691328,Pharmacist-led telehealth disease management program for patients with diabetes and depression.,"INTRODUCTION The aim of this study was to determine whether a pharmacist-led telehealth disease management program is superior to usual care of nurse-led telehealth in improving diabetes medication adherence, haemoglobin A1C (A1C), and depression scores in patients with concomitant diabetes and depression. METHODS Patients with diabetes and depression were randomized to pharmacist-led or nurse-led telehealth. Veterans with type 1 or type 2 diabetes, an A1C ≥ 7.5%, diagnosis of depression, and access to a landline phone were invited to participate. Patients were randomized to usual care of nurse-led telehealth or pharmacist-led telehealth. Patients were shown how to use the telehealth equipment by the nurse or pharmacist. In the pharmacist-led group, the patients received an in-depth medication review in addition to the instruction on the telehealth equipment. RESULTS After six months, the pharmacist-led telehealth arm showed significant improvements for cardiovascular medication adherence (14.0; 95% confidence interval (CI) 0.4 to 27.6), antidepressant medication adherence (26.0; 95% CI 0.9 to 51.2), and overall medication adherence combined (13.9; 95% CI 6.6 to 21.2) from baseline to six-month follow-up. There was a significant difference in A1C between each group at the six-month follow-up in the nurse-led telehealth group (6.9 ± 0.9) as compared to the pharmacist-led telehealth group (8.8 ± 2.0). There was no significance in the change in patient health questionnaire-9 (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) from baseline to follow-up in both groups. DISCUSSION Pharmacist-led telehealth was efficacious in improving medication adherence for cardiovascular, antidepressants, and overall medications over a six-month period as compared to nurse-led telehealth. There was no significant improvement in overall depression scores.",2020,There was no significance in the change in patient health questionnaire-9,"['patients with concomitant diabetes and depression', 'patients with diabetes and depression', 'Veterans with type 1 or type 2 diabetes, an A1C\u2009≥\u20097.5%, diagnosis of depression, and access to a landline phone were invited to participate', 'Patients with diabetes and depression']","['pharmacist-led or nurse-led telehealth', 'pharmacist-led telehealth disease management program', 'Pharmacist-led telehealth disease management', 'usual care of nurse-led telehealth or pharmacist-led telehealth']","['diabetes medication adherence, haemoglobin A1C (A1C), and depression scores', 'overall medication adherence', 'cardiovascular medication adherence', 'A1C', 'patient health questionnaire-9', 'PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D', 'antidepressant medication adherence', 'overall depression scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]",,0.0341936,There was no significance in the change in patient health questionnaire-9,"[{'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Cohen', 'Affiliation': 'Department of Pharmacy Practice, University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Tracey H', 'Initials': 'TH', 'LastName': 'Taveira', 'Affiliation': 'Department of Pharmacy Practice, University of Rhode Island, Kingston, USA.'}, {'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Veterans Administration Medical Center, Providence, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Pirraglia', 'Affiliation': 'Alpert Medical School, Brown University, Providence, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18822575'] 1213,31644933,Brain activation patterns associated with paragraph learning in persons with multiple sclerosis: The MEMREHAB trial.,"The modified Story Memory Technique (mSMT) is a memory rehabilitation program that combines training in visualization and context formation to improve learning and memory. Previous studies have shown improvement in learning and memory in individuals with multiple sclerosis (MS) after undergoing the mSMT, including changes in brain activity related to working memory and word encoding. The current study examined changes in brain activity in 16 individuals diagnosed with MS (n treatment  = 6; n placebo control  = 10) when they were presented with to-be-remembered information within a meaningful context (i.e. a paragraph) from before to after mSMT treatment. We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN). Consistent with this prediction, fMRI results revealed reduced brain activation in the LAN, DMN and ECN after completing the mSMT treatment in the context of paragraph learning. While no significant behavioral changes were observed, a marginally significant improvement with a large effect size was noted between baseline and follow-up performance on the Rivermead Behavioral Memory Test in persons who completed treatment. Results are discussed in terms of the impact of imagery training on patterns of cerebral activation when learning words presented within a context.",2020,"We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN).","['persons with multiple sclerosis', '16 individuals diagnosed with MS (n treatment \u202f=\u202f6; n placebo control \u202f=\u202f10', 'individuals with multiple sclerosis (MS']","['imagery training', 'paragraph learning', 'modified Story Memory Technique (mSMT']","['brain activity', 'behavioral changes', 'brain activation']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",16.0,0.0162649,"We expected treatment-related changes in brain activation in the language network (LAN), default mode network (DMN), and executive control network (ECN).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Boukrina', 'Affiliation': 'Center for Stroke Rehabilitation Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Dobryakova', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Schneider', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Center for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Center for Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, USA; Center for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-New Jersey Medical School Newark, NJ, USA. Electronic address: nchiaravalloti@kesslerfoundation.org.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.09.008'] 1214,31694653,Leap motion controlled video game-based therapy for upper limb rehabilitation in patients with Parkinson's disease: a feasibility study.,"BACKGROUND Non-immersive video games are currently being used as technological rehabilitation tools for individuals with Parkinson's disease (PD). The aim of this feasibility study was to evaluate the effectiveness of the Leap Motion Controller® (LMC) system used with serious games designed for the upper limb (UL), as well as the levels of satisfaction and compliance among patients in mild-to-moderate stages of the disease. METHODS A non-probabilistic sampling of non-consecutive cases was performed. 23 PD patients, in stages II-IV of the Hoehn & Yahr scale, were randomized into two groups: an experimental group (n = 12) who received treatment based on serious games designed by the research team using the LMC system for the UL, and a control group (n = 11) who received a specific intervention for the UL. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, as well as satisfaction and compliance, were assessed in both groups pre-treatment and post-treatment. RESULTS Within the experimental group, significant improvements were observed in all post-treatment assessments, except for Box and Blocks test for the less affected side. Clinical improvements were observed for all assessments in the control group. Statistical intergroup analysis showed significant improvements in coordination, speed of movements and fine motor dexterity scores on the more affected side of patients in the experimental group. CONCLUSIONS The LMC system and the serious games designed may be a feasible rehabilitation tool for the improvement of coordination, speed of movements and fine UL dexterity in PD patients. Further studies are needed to confirm these preliminary findings.",2019,"Statistical intergroup analysis showed significant improvements in coordination, speed of movements and fine motor dexterity scores on the more affected side of patients in the experimental group. ","['23 PD patients, in stages II-IV of the Hoehn & Yahr scale', ""patients with Parkinson's disease"", ""individuals with Parkinson's disease (PD"", 'patients in mild-to-moderate stages of the disease', 'PD patients']","['experimental group (n\u2009=\u200912) who received treatment based on serious games designed by the research team using the LMC system for the UL, and a control group (n\u2009=\u200911) who received a specific intervention for the UL', 'Leap motion controlled video game-based therapy', 'Leap Motion Controller® (LMC) system']","['Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, as well as satisfaction and compliance', 'coordination, speed of movements and fine motor dexterity scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0145448,"Statistical intergroup analysis showed significant improvements in coordination, speed of movements and fine motor dexterity scores on the more affected side of patients in the experimental group. ","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Fernández-González', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carratalá-Tejada', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Monge-Pereira', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Collado-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sánchez-Herrera Baeza', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cuesta-Gómez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain. alicia.cuesta@urjc.es.'}, {'ForeName': 'Edwin Daniel', 'Initials': 'ED', 'LastName': 'Oña-Simbaña', 'Affiliation': 'Robotics Lab, University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jardón-Huete', 'Affiliation': 'Robotics Lab, University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Molina-Rueda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balaguer-Bernaldo de Quirós', 'Affiliation': 'Robotics Lab, University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Miangolarra-Page', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de la Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation. Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0593-x'] 1215,31560580,"Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.","PURPOSE Many older women will be treated with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in this class. The current pooled analysis examines the efficacy and safety of this combination in older women. PATIENTS AND METHODS We pooled data from three randomized controlled studies (N = 1,827) of different CDK4/6 inhibitors in combination with an AI for initial treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. The effect of age on progression-free survival was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model. RESULTS For patients age 75 years or older (n = 198) who were treated with a CDK4/6 inhibitor and an AI, hazard ratio was 0.49 (95% CI, 0.31 to 0.76) with an estimated median progression-free survival of 31.1 months (95% CI, 20.2 months to not reached) versus 13.7 months (95% CI, 10.9 months to 24.9 months) for those treated with an AI. Incidence of grade 3 to 4 adverse events was 88.8% in patients age 75 years and older and 73.4% in patients younger than age 75 years. Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor. CONCLUSION There was similar efficacy with a CDK4/6 inhibitor in combination with an AI compared with AI alone for first-line treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer in older women compared with younger patients. Patients older than age 75 years experienced higher rates of toxicity, dose modifications, and a decrease from baseline in quality-of-life measures.",2019,"Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor. ","['For patients age 75 years or older (n = 198) who were treated with a', 'Patients older than age 75 years', 'postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer', 'Patients age 75 years or older', 'older women', 'Older Women With', 'We pooled data from three randomized controlled studies (N = 1,827) of different']","['CDK4/6 inhibitors in combination with an AI', 'CDK4/6 Inhibitor and an Aromatase Inhibitor', 'cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and an aromatase inhibitor (AI', 'CDK4/6 inhibitor']","['quality-of-life measures', 'progression-free survival', 'efficacy and safety', 'median progression-free survival', 'rates of toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0653491,"Patients age 75 years or older reported a decline in quality-of-life measures using the EQ-5D regardless of treatment with AI alone or with the addition of a CDK4/6 inhibitor. ","[{'ForeName': 'Lynn J', 'Initials': 'LJ', 'LastName': 'Howie', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Wedam', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Tatiana M', 'Initials': 'TM', 'LastName': 'Prowell', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Kluetz', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Belinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gao', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Theoret', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'US Food and Drug Administration, White Oak, MD.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02217'] 1216,30658935,"PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study.","BACKGROUND Increased-dose bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP escalated ) improves progression-free survival in patients with advanced Hodgkin lymphoma compared with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), but is associated with increased risks of haematological toxicity, secondary myelodysplasia or leukaemia, and infertility. We investigated whether PET monitoring during treatment could allow dose de-escalation by switching regimen (BEACOPP escalated to ABVD) in early responders without loss of disease control compared with standard treatment without PET monitoring. METHODS AHL2011 is a randomised, non-inferiority, phase 3 study done in 90 centres across Belgium and France. Eligible patients were aged 16-60 years and had newly diagnosed Hodgkin lymphoma, excluding nodular lymphocyte predominant subtype, an Eastern Cooperative Oncology Group performance status score less than 3, a life expectancy of at least 3 months, an Ann Arbor disease stage III, IV, or IIB with mediastinum-to-thorax ratio of 0·33 or greater than or extranodal localisation, and had received no previous treatment for Hodgkin lymphoma. Randomisation was unmasked and done centrally by the permuted block method. Patients were randomly assigned to standard treatment (BEACOPP escalated given every 21 days for six cycles) or PET-driven treatment. All patients received two cycles of upfront BEACOPP escalated , after which PET assessment was done (PET2). In the standard treatment group, PET2 patients completed two additional cycles of BEACOPP escalated induction therapy irrespective of PET2 findings. In the PET-driven treatment group, patients with positive PET2 scans received the further two cycles of BEACOPP escalated and those with a negative PET2 scan switched to two cycles of ABVD for the remaining induction therapy. In both treatment groups, PET at the end of induction therapy was used to decide whether to continue with consolidation therapy in those with negative scans or start salvage therapy in patients with positive scans (either two cycles of ABVD in PET2-negative patients in the PET-driven arm or two cycles of BEACOPP escalated ). BEACOPP escalated consisted of bleomycin 10 mg/m 2 and vincristine 1·4 mg/m 2 intravenously on day 8, etoposide 200 mg/m 2 intravenously on days 1-3, doxorubicin 35 mg/m 2 and cyclophosphamide 1250 mg/m 2 intravenously on day 1, 100 mg/m 2 oral procarbazine on days 1-7, and 40 mg/m 2 oral prednisone on days 1-14. ABVD was given every 28 days (doxorubicin 25 mg/m 2 , bleomycin 10 mg/m 2 , vinblastine 6 mg/m 2 , and dacarbazine 375 mg/m 2 intravenously on days 1 and 15). The primary endpoint was investigator-assessed progression-free survival. Non-inferiority analyses were done by intention to treat and per protocol. The study had a non-inferiority margin of 10%, to show non-inferiority of PET-guided treatment versus standard care with 80% power and an alpha of 2·5% (one-sided). This study is registered with ClinicalTrials.gov, number NCT01358747. FINDINGS From May 19, 2011, to April 29, 2014, 823 patients were enrolled-413 in the standard care group and 410 in the PET-driven group. 346 (84%) of 410 patients in the PET-driven treatment group were assigned to receive ABVD and 51 (12%) to continue receiving BEACOPP escalated after PET2. With a median follow-up of 50·4 months (IQR 42·9-59·3), 5-year progression-free survival by intention to treat was 86·2%, 95% CI 81·6-89·8 in the standard treatment group versus 85·7%, 81·4-89·1 in the PET-driven treatment group (hazard ratio [HR] 1·084, 95% CI 0·737-1·596; p=0·65) and per protocol the values were 86·7%, 95% CI 81·9-90·3 and 85·4%, 80·7-89·0, respectively (HR 1·144, 0·758-1·726; p=0·74). The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]). Serious adverse events related to treatment were reported in 192 (47%) patients in the standard treatment group and 114 (28%) in the PET-driven treatment group, including infections (84 [20%] of 412 vs 50 [12%] of 407) and febrile neutropenia (21 [5%] vs 23 [6%]). Six (1%) patients in the standard care group died from treatment-related causes (two from septic shock, two from pneumopathy, one from heart failure, and one from acute myeloblastic leukaemia), as did two (<1%) in the PET-driven treatment group (one from septic shock and one from acute myeloblastic leukaemia). INTERPRETATION PET after two cycles of induction BEACOPP escalated chemotherapy safely guided treatment in patients with advanced Hodgkin lymphoma and allowed the use of ABVD in early responders without impairing disease control and reduced toxicities. PET staging allowed accurate monitoring of treatment in this trial and could be considered as a strategy for the routine management of patients with advanced Hodgkin lymphoma. FUNDING Programme Hospitalier de Recherche Clinique.",2019,"The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]).","['Eligible patients were aged 16-60 years and had newly diagnosed Hodgkin lymphoma, excluding nodular lymphocyte predominant subtype, an Eastern Cooperative Oncology Group performance status score less than 3, a life expectancy of at least 3 months, an Ann Arbor disease stage III, IV, or IIB with mediastinum-to-thorax ratio of 0·33 or greater than or extranodal localisation, and had received no previous treatment for Hodgkin lymphoma', 'newly diagnosed advanced Hodgkin lymphoma (AHL2011', 'patients with advanced Hodgkin lymphoma', 'From May 19, 2011, to April 29, 2014, 823 patients were enrolled-413 in the standard care group and 410 in the PET-driven group', '90 centres across Belgium and France']","['bleomycin', 'BEACOPP', 'upfront BEACOPP', 'vincristine 1·4', 'etoposide', 'cyclophosphamide 1250', 'doxorubicin 25 mg/m 2 , bleomycin 10 mg/m 2 , vinblastine 6 mg/m 2 , and dacarbazine', 'standard treatment (BEACOPP escalated given every 21 days for six cycles) or PET-driven treatment', 'bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP escalated ', 'BEACOPP escalated after PET2', 'doxorubicin 35', 'PET-adapted treatment', 'doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD', 'ABVD', 'procarbazine']","['anaemia', 'febrile neutropenia', 'progression-free survival', 'neutropenia', 'toxicities', '5-year progression-free survival', 'leucopenia', 'investigator-assessed progression-free survival', 'infections', 'Serious adverse events', 'thrombocytopenia', 'gastrointestinal disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}]",823.0,0.218624,"The most common grade 3-4 adverse events were leucopenia (381 [92%] in the standard treatment group and 387 [95%] in the PET-driven treatment group), neutropenia (359 [87%] and 366 [90%]), anaemia (286 [69%] vs 114 [28%]), thrombocytopenia (271 [66%] and 163 [40%]), febrile neutropenia (145 [35%] and 93 [23%]), infections (88 [22%] and 47 [11%]), and gastrointestinal disorders (49 [11%] and 48 [11%]).","[{'ForeName': 'René-Olivier', 'Initials': 'RO', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology, University Hospital F Mitterrand and Inserm UMR 1231, Dijon, France. Electronic address: olivier.casasnovas@chu-dijon.fr.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Haematology, Institut P Calmette, Marseille, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Department of Haematology, APHP, Hôpital Saint Louis, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Lazarovici', 'Affiliation': 'Department of Haematology, Université Paris-Saclay, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ghesquieres', 'Affiliation': 'Department of Haematology, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud and Université Claude Bernard Lyon-1, Pierre Bénite, France.'}, {'ForeName': 'Aspasia', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': 'Department of Haematology, Centre H Becquerel, Rouen, France.'}, {'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Dupuis', 'Affiliation': 'Department of Haematology, Hôpital H Mondor, Creteil, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Gac', 'Affiliation': ""Department of Haematology, Institut d'hématologie de Basse Normandie, Caen, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gastinne', 'Affiliation': 'Department of Haematology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Joly', 'Affiliation': 'Department of Haematology, Hospital Sud Francilien, Corbeille-Essonnes, France.'}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Department of Haematology, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'Department of Haematology, Centre L Bérard, Lyon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Department of Haematology, University Hospital of Nancy, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'EA 7365 Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA), Department of Haematology, CHU Lille, Université de Lille, Lille, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Delarue', 'Affiliation': 'Department of Haematology, Hôpital Necker, Paris, France.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Farhat', 'Affiliation': 'Department of Haematology, Hôpital Mignot, Versailles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Quittet', 'Affiliation': 'Department of Haematology, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Berriolo-Riedinger', 'Affiliation': 'Department of Nuclear Medicine, Centre G F Leclerc, Dijon, France.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tempescul', 'Affiliation': 'Department of Haematology, University Hospital of Brest, Brest, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Edeline', 'Affiliation': 'Department of Nuclear Medicine, Hôpital R Huguenin, Institut Curie, St-Cloud, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Maisonneuve', 'Affiliation': 'Department of Haematology, Centre Hospitalier Départemental de Vendée, Hôpital de La Roche sur Yon, La Roche sur Yon, France.'}, {'ForeName': 'Luc-Matthieu', 'Initials': 'LM', 'LastName': 'Fornecker', 'Affiliation': 'Department of Haematology, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': 'Department of Haematology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Delmer', 'Affiliation': 'Department of Haematology, University Hospital of Reims, Reims, France.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Dartigues', 'Affiliation': 'Department of Pathology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Pathology, University Hospital F Mitterrand and Inserm UMR 1231, Dijon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Department of Haematology, CHU UCL Namur, Université Catholique de Louvain, Yvoir, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mounier', 'Affiliation': 'Department of Haematology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Traverse-Glehen', 'Affiliation': 'Department of Pathology, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud and Université Claude Bernard Lyon-1, Pierre Bénite, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': 'LYSA Imaging, Hôpital H Mondor, Creteil, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30784-8'] 1217,30718190,Effects of Chromotherapy on the Cognitive Ability of Older Adults: A Quasi-Experimental Study.,"OBJECTIVE This study aimed to assess the effects of chromotherapy on the cognitive ability of older adults. METHODS This quasi-experimental pretest and posttest study was conducted among 135 older adults in Ilocos Sur, Philippines, between August and September 2015. The participants were divided into three groups: red, green, and white lights, with 45 people in each group. The cognitive ability of older adults was measured using an adapted Mini-Mental State Exam (MMSE). RESULTS After the interventions, the red and green light experimental groups acquired a modest increase in cognitive ability scores against the comparison white light group (p < 0.001). However, the effects were not significantly different between the red and green lights postintervention (p > 0.05). CONCLUSION The chromotherapy is effective in improving the cognitive ability of older adults. Specifically, the red and green lights are better than the white light in increasing the cognitive ability of older adults.",2019,"However, the effects were not significantly different between the red and green lights postintervention (p > 0.05). ","['135 older adults in Ilocos Sur, Philippines, between August and September 2015', 'Older Adults', 'older adults']","['chromotherapy', 'Chromotherapy', 'adapted Mini-Mental State Exam (MMSE']",['cognitive ability scores'],"[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085102', 'cui_str': 'Chromatotherapy'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",135.0,0.0214111,"However, the effects were not significantly different between the red and green lights postintervention (p > 0.05). ","[{'ForeName': 'Emmanuel D', 'Initials': 'ED', 'LastName': 'Paragas', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines; Nursing Services Department, JW Ruby Memorial Hospital, West Virginia University Medicine, Morgantown, WV, USA. Electronic address: emmanparagasjr@yahoo.com.'}, {'ForeName': 'Abigail Therese Y', 'Initials': 'ATY', 'LastName': 'Ng', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: yapng.abigail@gmail.com.'}, {'ForeName': 'Denice Victoria L', 'Initials': 'DVL', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: denicevictoria019@gmail.com.'}, {'ForeName': 'Gerald Andrei B', 'Initials': 'GAB', 'LastName': 'Reyes', 'Affiliation': 'College of Nursing, University of Santo Tomas, España Blvd., Sampaloc, Manila, Philippines. Electronic address: geraldandrei.reyes@gmail.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.01.002'] 1218,31693918,The prebiotic effect of CPP-ACP sugar-free chewing gum.,"OBJECTIVES To determine if chewing gum containing casein phosphopeptide stabilised amorphous calcium phosphate (CPP-ACP) promoted an increase in the abundance of Streptococcus sanguinis and other species associated with dental health in supragingival plaque in a clinical study. MATERIALS AND METHODS Nineteen participants were recruited for a three-leg cross-over, randomised, controlled clinical trial. Participants chewed a sugar-free gum with or without CPP-ACP six times daily for 20 min over two weeks. The study also involved no gum chewing (no gum) for the same two week period. Participants were randomly assigned to one of the test gums or no gum for each intervention period. Participants abstained from oral hygiene and had washout periods of two weeks between intervention periods. After each intervention period, supragingival plaque was collected and analysed for bacterial composition by sequencing the V4 variable region of the 16S rRNA gene. Data were analysed using a linear mixed model. RESULTS The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention. All the species that were promoted by the CPP-ACP gum are known to possess one or both of the alkali-producing enzymes arginine deiminase and nitrate reductase. CONCLUSION This clinical study demonstrated that chewing a sugar-free gum containing CPP-ACP promoted prebiosis by significantly increasing the proportion of S. sanguinis and other health-associated bacterial species in supragingival plaque. CLINICAL SIGNIFICANCE Regular chewing of CPP-ACP sugar-free gum increases the proportions of health-associated commensal species in supragingival plaque to promote prebiosis and oral homeostasis.",2019,"The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention.",['Nineteen participants were recruited for a three-leg cross'],"['chewing gum containing casein phosphopeptide stabilised amorphous calcium phosphate (CPP-ACP', 'test gums or no gum', 'sugar-free gum with or without CPP-ACP', 'CPP-ACP sugar-free gum', 'CPP-ACP Sugar-Free Chewing Gum']","['proportions of S. sanguinis', 'supragingival plaque']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}]","[{'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0399452', 'cui_str': 'Supragingival dental plaque (disorder)'}]",19.0,0.0149478,"The CPP-ACP gum intervention produced a significant (p < 0.01) increase in the proportions of S. sanguinis (112%), as well as the commensal species Rothia dentocariosa (127%), Corynebacterium durum (80%) and Streptococcus mitis (55%) when compared with the no gum intervention.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Fernando', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Butler', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey G', 'Initials': 'GG', 'LastName': 'Adams', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Mitchell', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Dashper', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Escobar', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Hoffmann', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Peiyan', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Walker', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Victoria, Australia. Electronic address: e.reynolds@unimelb.edu.au.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103225'] 1219,31685256,Predicting the Prognosis of Fuchs Endothelial Corneal Dystrophy by Using Scheimpflug Tomography.,"PURPOSE To determine if Scheimpflug tomography pachymetry map and posterior elevation map patterns, central corneal thickness (CCT), and corneal backscatter can predict the prognosis of Fuchs endothelial corneal dystrophy (FECD). DESIGN Cross-sectional study with follow-up of outcomes. PARTICIPANTS Ninety-six eyes (56 subjects) with a range of severity of FECD. METHODS Corneas were graded by cornea specialists according to the area and confluence of guttae and the presence of clinically definite edema. Masked and randomized Scheimpflug imaging pachymetry map and posterior elevation map patterns were assessed by 1 observer for loss of regular isopachs, displacement of the thinnest point of the cornea, and the presence of posterior surface depression. The prognosis of eyes over a 5-year (median) follow-up period was determined based on FECD progression (new onset of clinically definite edema or ≥5% increase in CCT) or intervention by endothelial keratoplasty. Cumulative probabilities of progression and intervention were estimated from survival analyses, with risk factors determined by using Cox proportional hazards models. MAIN OUTCOME MEASURES Pachymetry map and posterior elevation map patterns, corneal backscatter, and CCT (ultrasonic pachymetry). RESULTS In univariate analyses, loss of regular isopachs (hazard ratio [HR], 18.00) displacement of the thinnest point (HR, 11.53), focal posterior surface depression (HR, 10.21), and anterior corneal backscatter (HR, 1.22, per 1-grayscale unit increment), were risk factors for progression or intervention (P < 0.001), whereas CCT (HR, 1.30, per 25-μm increment) was not (P = 0.15). In multivariate analyses, loss of regular isopachs (HR, 11.57; P < 0.001) and displacement of the thinnest point (HR, 5.61; P = 0.02) were independent and clinically important risk factors for progression and intervention. The 5-year cumulative risk of disease progression and intervention was 7%, 48%, and 89% when none, 1 or 2, and all 3 pachymetry map and posterior elevation map parameters were present, respectively (P <0.001). The 4-year cumulative risk of disease progression and intervention after uncomplicated cataract surgery was 0%, 50%, and 75% when none, 1 or 2, and all 3 pachymetry map and posterior elevation map parameters were present, respectively (P < 0.001). CONCLUSIONS Three Scheimpflug tomography pachymetry map and posterior elevation map patterns can predict FECD prognosis independent of CCT. The risk of FECD progression and intervention, including after uncomplicated cataract surgery, increases according to the number of parameters present.",2020,"In multivariate analyses, loss of regular isopachs (HR, 11.57; P < 0.001) and displacement of the thinnest point (HR, 5.61; P = 0.02) were independent and clinically important risk factors for progression and intervention.",['Ninety-six eyes (56 subjects) with a range of severity of FECD'],[],"['loss of regular isopachs (hazard ratio [HR], 18.00) displacement of the thinnest point (HR, 11.53), focal posterior surface depression (HR, 10.21), and anterior corneal backscatter', 'Pachymetry map and posterior elevation map patterns, corneal backscatter, and CCT (ultrasonic pachymetry', '5-year cumulative risk of disease progression and intervention', '4-year cumulative risk of disease progression']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",[],"[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]",56.0,0.0562871,"In multivariate analyses, loss of regular isopachs (HR, 11.57; P < 0.001) and displacement of the thinnest point (HR, 5.61; P = 0.02) were independent and clinically important risk factors for progression and intervention.","[{'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. Electronic address: Patel.Sanjay@mayo.edu.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Hodge', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Treichel', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Baratz', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.033'] 1220,11668655,New approach to localize speech relevant brain areas and hemispheric dominance using spatially filtered magnetoencephalography.,"We used a current localization by spatial filtering-technique to determine primary language areas with magnetoencephalography (MEG) using a silent reading and a silent naming task. In all cases we could localize the sensory speech area (Wernicke) in the posterior part of the left superior temporal gyrus (Brodmann area 22) and the motor speech area (Broca) in the left inferior frontal gyrus (Brodmann area 44). Left hemispheric speech dominance was determined in all cases by a laterality index comparing the current source strength of the activated left side speech areas to their right side homologous. In 12 cases we found early Wernicke and later Broca activation corresponding to the Wernicke-Geschwind model. In three cases, however, we also found early Broca activation indicating that speech-related brain areas need not necessarily be activated sequentially but can also be activated simultaneously. Magnetoencephalography can be a potent tool for functional mapping of speech-related brain areas in individuals, investigating the time-course of brain activation, and identifying the speech dominant hemisphere. This may have implications for presurgical planning in epilepsy and brain tumor patients.",2001,In all cases we could localize the sensory speech area (Wernicke) in the posterior part of the left superior temporal gyrus (Brodmann area 22) and the motor speech area (Broca) in the left inferior frontal gyrus (Brodmann area 44).,[],"['spatial filtering-technique to determine primary language areas with magnetoencephalography (MEG', 'Magnetoencephalography']","['Left hemispheric speech dominance', 'early Wernicke and later Broca activation']",[],"[{'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.0101201,In all cases we could localize the sensory speech area (Wernicke) in the posterior part of the left superior temporal gyrus (Brodmann area 22) and the motor speech area (Broca) in the left inferior frontal gyrus (Brodmann area 44).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'Department of Neurosurgery, University of Erlangen-Nürnberg, Erlangen, Germany. kober@nch.imed.uni-erlangen.de'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nimsky', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vieth', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fahlbusch', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ganslandt', 'Affiliation': ''}]",Human brain mapping,[] 1221,31675546,A randomized controlled trial evaluating integrated versus phased application of evidence-based psychotherapies for military veterans with comorbid PTSD and substance use disorders.,"OBJECTIVE Recent clinical practice guidelines recommend the delivery of evidence-based psychotherapies for both substance use disorder (SUD) and posttraumatic stress disorder (PTSD) within the same treatment episode for patients with SUD/PTSD comorbidity. This randomized clinical trial evaluated the comparative effectiveness of integrating versus phasing evidence-based psychotherapies for SUD and PTSD among veterans with co-occurring SUD/ PTSD. METHOD 183 veterans with DSM-IV PTSD and SUD at two VA Medical Centers were randomized to one of two psychotherapies during which Motivational Enhancement Therapy [MET] for SUD and Prolonged Exposure [PE] for PTSD were either phased or integrated throughout treatment. Primary outcomes as evaluated by blinded assessors were percent days with drug use or heavy drinking and PTSD symptomology. We hypothesized integrated MET/PE (n = 95) would yield better SUD and PTSD-related outcomes at posttreatment than phased MET/PE (n = 88). RESULTS In intent-to-treat analyses (n=183), both treatment groups achieved clinically (d=0.46 - 1.06) and statistically significant reductions in SUD (p < 0.01) and PTSD (p < 0.01) symptomology; the time by treatment interactions were not significant. Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). CONCLUSIONS Our hypothesis that integrated MET/PE would result in better outcomes than phased MET/PE across a range of PTSD and SUD measures was not supported; both strategies for combining two single-disorder treatments for co-occurring SUD/PTSD yielded significant symptom reduction.",2019,"Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). ","['military veterans with comorbid PTSD and substance use disorders', '183 veterans with DSM-IV PTSD and SUD at two VA Medical Centers', 'veterans with co-occurring SUD/ PTSD', 'patients with SUD/PTSD comorbidity']","['psychotherapies during which Motivational Enhancement Therapy [MET] for SUD and Prolonged Exposure [PE', 'evidence-based psychotherapies', 'integrating versus phasing evidence-based psychotherapies']","['drug use or heavy drinking and PTSD symptomology', 'PTSD', 'SUD']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]",183.0,0.0395958,"Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). ","[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Kehle-Forbes', 'Affiliation': ""National Center for PTSD Women's Health Sciences Division at VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, United States; Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; University of Minnesota Medical School, 420 Delaware St SE, Minneapolis, MN 55455, United States. Electronic address: Shannon.Kehle-Forbes@va.gov.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Polusny', 'Affiliation': 'Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; Department of Psychiatry, University of Minnesota, 2450 Riverside Ave S, Minneapolis MN 55454, United States.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Koffel', 'Affiliation': 'Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; Department of Psychiatry, University of Minnesota, 2450 Riverside Ave S, Minneapolis MN 55454, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ingram', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Deborah H A', 'Initials': 'DHA', 'LastName': 'Van Horn', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Drapkin', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States; Rutgers, The State University of New Jersey, 61 Nichol Ave, New Brunswick, NJ 08901, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Yusko', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107647'] 1222,30257956,Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant.,"Antibiotic treatment can deplete the commensal bacteria of a patient's gut microbiota and, paradoxically, increase their risk of subsequent infections. In allogeneic hematopoietic stem cell transplantation (allo-HSCT), antibiotic administration is essential for optimal clinical outcomes but significantly disrupts intestinal microbiota diversity, leading to loss of many beneficial microbes. Although gut microbiota diversity loss during allo-HSCT is associated with increased mortality, approaches to reestablish depleted commensal bacteria have yet to be developed. We have initiated a randomized, controlled clinical trial of autologous fecal microbiota transplantation (auto-FMT) versus no intervention and have analyzed the intestinal microbiota profiles of 25 allo-HSCT patients (14 who received auto-FMT treatment and 11 control patients who did not). Changes in gut microbiota diversity and composition revealed that the auto-FMT intervention boosted microbial diversity and reestablished the intestinal microbiota composition that the patient had before antibiotic treatment and allo-HSCT. These results demonstrate the potential for fecal sample banking and posttreatment remediation of a patient's gut microbiota after microbiota-depleting antibiotic treatment during allo-HSCT.",2018,"We have initiated a randomized, controlled clinical trial of autologous fecal microbiota transplantation (auto-FMT) versus no intervention and have analyzed the intestinal microbiota profiles of 25 allo-HSCT patients (14 who received auto-FMT treatment and 11 control patients who did not).","['gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant', '25 allo-HSCT patients (14 who received auto-FMT treatment and 11 control patients who did not']","['Antibiotic treatment', 'allogeneic hematopoietic stem cell transplantation (allo-HSCT', 'autologous fecal microbiota transplantation (auto-FMT']",['intestinal microbiota composition'],"[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0342521,"We have initiated a randomized, controlled clinical trial of autologous fecal microbiota transplantation (auto-FMT) versus no intervention and have analyzed the intestinal microbiota profiles of 25 allo-HSCT patients (14 who received auto-FMT treatment and 11 control patients who did not).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Taur', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Coyte', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schluter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Robilotti', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Figueroa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Mergim', 'Initials': 'M', 'LastName': 'Gjonbalaj', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Littmann', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Lilan', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Yangtsho', 'Initials': 'Y', 'LastName': 'Gyaltshen', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fontana', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Sejal', 'Initials': 'S', 'LastName': 'Morjaria', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Boglarka', 'Initials': 'B', 'LastName': 'Gyurkocza', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Miguel-Angel', 'Initials': 'MA', 'LastName': 'Perales', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Castro-Malaspina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Tamari', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Ponce', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Koehne', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Barker', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Jakubowski', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Papadopoulos', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Parastoo', 'Initials': 'P', 'LastName': 'Dahi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shaffer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Young', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Peled', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Meagher', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Jenq', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Marcel R M', 'Initials': 'MRM', 'LastName': 'van den Brink', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Giralt', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Pamer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. pamere@mskcc.org xavierj@mskcc.org.'}, {'ForeName': 'Joao B', 'Initials': 'JB', 'LastName': 'Xavier', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. pamere@mskcc.org xavierj@mskcc.org.'}]",Science translational medicine,['10.1126/scitranslmed.aap9489'] 1223,30665869,"Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND Patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations have poor prognosis. We aimed to establish the efficacy of ramucirumab in patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher. METHODS REACH-2 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 92 hospitals, clinics, and medical centres in 20 countries. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1, α-fetoprotein concentrations of 400 ng/mL or greater, and had previously received first-line sorafenib. Participants were randomly assigned (2:1) via an interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo. All patients received best supportive care. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with α-fetoprotein concentrations of 400 ng/mL or greater. Efficacy analyses were by intention to treat, whereas safety analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02435433. FINDINGS Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the placebo group. At a median follow-up of 7·6 months (IQR 4·0-12·5), median overall survival (8·5 months [95% CI 7·0-10·6] vs 7·3 months [5·4-9·1]; hazard ratio [HR] 0·710 [95% CI 0·531-0·949]; p=0·0199) and progression-free survival (2·8 months [2·8-4·1] vs 1·6 months [1·5-2·7]; 0·452 [0·339-0·603]; p<0·0001) were significantly improved in the ramucirumab group compared with the placebo group. The proportion of patients with an objective response did not differ significantly between groups (nine [5%] of 197 vs one [1%] of 95; p=0·1697). Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups. Grade 3 or worse treatment-emergent adverse events that occurred in at least 5% of patients in either group were hypertension (25 [13%] in the ramucirumab group vs five [5%] in the placebo group), hyponatraemia (11 [6%] vs 0) and increased aspartate aminotransferase (six [3%] vs five [5%]). Serious adverse events of any grade and cause occurred in 68 (35%) patients in the ramucirumab group and 28 (29%) patients in the placebo group. Three patients in the ramucirumab group died from treatment-emergent adverse events that were judged to be related to study treatment (one had acute kidney injury, one had hepatorenal syndrome, and one had renal failure). INTERPRETATION REACH-2 met its primary endpoint, showing improved overall survival for ramucirumab compared with placebo in patients with hepatocellular carcinoma and α-fetoprotein concentrations of at least 400 ng/mL who had previously received sorafenib. Ramucirumab was well tolerated, with a manageable safety profile. To our knowledge, REACH-2 is the first positive phase 3 trial done in a biomarker-selected patient population with hepatocellular carcinoma. FUNDING Eli Lilly.",2019,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"['Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the', 'patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher', 'Patients with advanced hepatocellular carcinoma', 'patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2', 'patient population with hepatocellular carcinoma', '92 hospitals, clinics, and medical centres in 20 countries', 'Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child']","['placebo', 'ramucirumab', 'Pugh class', 'Ramucirumab after sorafenib', 'Ramucirumab', 'sorafenib', 'interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo']","['ECOG performance statuses', 'aspartate aminotransferase', 'Median time to deterioration in FHSI-8 total scores', 'proportion of patients with an objective response', 'hyponatraemia', 'progression-free survival', 'hypertension', 'renal failure', 'Grade 3 or worse treatment-emergent adverse events', 'progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status', 'median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C0441781', 'cui_str': 'Stage B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",292.0,0.756414,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical Center, Boston, MA, USA. Electronic address: azhu@mgh.harvard.edu.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital Tainan, Taiwan; College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, New York, NY, USA; Institut d'Investigations Biomèdiques, August Pi i Sunyer-Hospital Clinic Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'University Hospital S Orsola, Bologna, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pracht', 'Affiliation': 'Centre Eugene Marquis, Rennes, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Rau', 'Affiliation': 'Chang Gung Memorial Hospital-Kaohsiung Branch, Kaohsiung City, Taiwan; Hematology-Oncology Department, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital-Hepatology, Iizuka, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East-Hepatobiliary and Pancreatic Oncology, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Azienda Ospedaliera G Rummo, Benevento, Benevento, Italy; Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Dong Bok', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gerken', 'Affiliation': 'Universtitätsklinikum Essen AöR, Essen, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Hiriart', 'Affiliation': 'CHU de Bordeaux, Pessac, France.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Eli Lilly, New York, NY, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University, Osaka-Sayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30937-9'] 1224,31608454,Transfusion-related immunomodulation: gamma irradiation alters the effects of leukoreduction on alloimmunization.,"BACKGROUND Adverse events following blood transfusion include allosensitization and generalized immunosuppression, collectively referred to as transfusion-related immune modulation. We evaluated the immunological effects of red blood cell (RBC) and platelet transfusions on alloantibody responses and on immunoregulatory cells in nonimmunosuppressed patients undergoing cardiovascular surgery. STUDY DESIGN AND METHODS Patients were randomized to receive standard unmodified (STD), leukoreduced (LR), or leukoreduced and γ-irradiated (LRγ) RBCs. Patients received only apheresis platelets that were in-process LR and were γ-irradiated for the third arm. Nontransfused patients served as controls for the effects of surgery itself on immunologic changes. Antibodies to HLA were assessed with use of solid-phase assays. The effects of transfusion on adaptive and innate immunity were evaluated by assessing T regulatory cells (Tregs) and invariant natural killer T (iNKT) cells. RESULTS LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies. However, if LR blood products were γ-irradiated, HLA antibody production was not reduced. Compared to nontransfused patients, recipients of STD or LR transfusions showed a significant increase in CD4+CD25 hi T cells expressing FoxP3 or CTLA4 and also of iNKT cells producing interleukin-4. In contrast, recipients of LRγ blood products showed markedly lower increases in all three cellular assays. CONCLUSION LR decreased HLA alloantibody production in naïve recipients, but did not reduce the immunosuppressive effects of transfusion. LRγ reduced immunosuppression and was not associated with decreased HLA alloantibody production.",2019,"RESULTS LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies.","['Patients', 'nonimmunosuppressed patients undergoing cardiovascular surgery']","['red blood cell (RBC) and platelet transfusions', 'standard unmodified (STD), leukoreduced (LR), or leukoreduced and γ-irradiated (LRγ) RBCs']","['immunosuppressive effects of transfusion', 'T regulatory cells (Tregs) and invariant natural killer T (iNKT) cells', 'CD4+CD25 hi T cells expressing FoxP3 or CTLA4 and also of iNKT cells producing interleukin-4', 'HLA antibody production', 'HLA alloantibody production', 'human leukocyte antigen (HLA) alloantibodies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C2350467', 'cui_str': 'iNKT Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0022144', 'cui_str': 'Alloantibodies'}, {'cui': 'C0033268'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}]",,0.0469828,"RESULTS LR of blood products reduced the development of human leukocyte antigen (HLA) alloantibodies, but only in patients without preexisting HLA antibodies.","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Nelson', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Aldea', 'Affiliation': 'Department of Surgery, Division of Cardiothoracic Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Warner', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Latchman', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Gunasekera', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Ayala', 'Initials': 'A', 'LastName': 'Tamir', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Gernsheimer', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Bolgiano', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}, {'ForeName': 'Sherrill J', 'Initials': 'SJ', 'LastName': 'Slichter', 'Affiliation': 'Bloodworks Northwest, Seattle, Washington.'}]",Transfusion,['10.1111/trf.15555'] 1225,30720579,Transcutaneous Neuromodulation at ST36 (Zusanli) is More Effective than Transcutaneous Tibial Nerve Stimulation in Treating Constipation.,"BACKGROUND AND GOALS Combined transcutaneous neuromodulation (TN) at acupoint ST36 (Zusanli) and TN at the posterior tibial nerve (PTN) has been reported effective in treating functional constipation. This study was designed to compare the effectiveness of TN between these 2 points. MATERIALS AND METHODS Eighteen functional constipation patients (M/F: 9/9) were recruited to participate in a cross-over study with a 2-week TN at ST36 and a 2-week TN at PTN. A bowel movement diary, and the questionnaires of Patient Assessment of Constipation Symptom (PAC-SYM) and Constipation Quality of Life (PAC-QoL) were completed; anorectal manometry and spectral analysis of heart rate variability for assessing the autonomic function were performed. RESULTS (1) Both TN at ST36 and TN at PTN improved constipation-related symptoms (PAC-SYM scores on pre-TN vs. post-TN: 1.4±0.1 vs. 0.6±0.1 for ST36, 1.4±0.1 vs. 0.9±0.1 for PTN, both P≤0.001). (2) TN at ST36, but not TN at PTN, increased the number of weekly spontaneous bowel movements (0.9±0.2 pre-TN vs. 3.5±0.7 post-TN, P<0.001) and decreased the total PAC-QoL score. TN at ST36 was more potent than TN at PTN in improving the PAC-SYM score (decrement 0.8±0.1 vs. 0.5±0.1, P<0.05). (3) TN at ST36 rather than TN at PTN resulted in a reduction in sensation thresholds, including rectal distention for urge (134.1±14.3 mL pre-TN vs. 85.6±6.5 mL post-TN, P<0.01) and maximum tolerance (P<0.05). (4) Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05). CONCLUSIONS TN at ST36 is more potent than TN at PTN in treating constipation and improving constipation-related symptoms and rectal sensation.",2020,"Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05). ",['Eighteen functional constipation patients (M/F: 9/9) were recruited to participate in a cross-over study with a 2-week TN at ST36 and a 2-week TN at PTN'],"['Transcutaneous Neuromodulation at ST36 (Zusanli', 'transcutaneous neuromodulation (TN) at acupoint ST36 (Zusanli) and TN at the posterior tibial nerve (PTN', 'Transcutaneous Tibial Nerve Stimulation']","['total PAC-QoL score', 'constipation-related symptoms (PAC-SYM scores', 'number of weekly spontaneous bowel movements', 'sensation thresholds, including rectal distention for urge', 'PAC-SYM score', 'questionnaires of Patient Assessment of Constipation Symptom (PAC-SYM) and Constipation Quality of Life (PAC-QoL', 'vagal activity and decreased sympathetic activity']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}]","[{'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",18.0,0.0186976,"Both TN at ST36 and TN at PTN significantly increased vagal activity and decreased sympathetic activity (P<0.05). ","[{'ForeName': 'Gao-Jue', 'Initials': 'GJ', 'LastName': 'Wu', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Ningbo Yinzhou People's Hospital, Ningbo, Zhejiang.""}, {'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}, {'ForeName': 'Jiande D Z', 'Initials': 'JDZ', 'LastName': 'Chen', 'Affiliation': 'Ningbo Pace Translational Medical Research Center, Beilun.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001184'] 1226,30713022,Individualization of the starting dose of follitropin delta reduces the overall OHSS risk and/or the need for additional preventive interventions: cumulative data over three stimulation cycles.,"RESEARCH QUESTION Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions? DESIGN A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123). Of 1326 women (aged 18-40 years) randomized and treated with follitropin delta or alfa in cycle 1, 513 continued to cycle 2 and 188 to cycle 3. Follitropin delta and alfa doses were maintained/adjusted according to ovarian response in the previous cycle. RESULTS Individualized dosing with follitropin delta significantly reduced moderate/severe OHSS and/or preventive interventions (P=0.018) versus conventional dosing with follitropin alfa in patients undergoing up to three ovarian stimulation cycles. The greatest benefit was observed in patients in the highest anti-Müllerian hormone (AMH) quartile (P=0.012). On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. CONCLUSION An individualized follitropin delta dosing regimen decreased the risk of moderate/severe OHSS as well as the incidence of preventive interventions versus a conventional follitropin alfa regimen. An analysis per AMH quartile indicated that these statistically significant differences are driven mainly by patients with the highest pretreatment AMH levels.",2019,"On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. ","['IVF/intracytoplasmic sperm injection patients', '1326 women (aged 18-40 years', 'patients undergoing up to three ovarian stimulation cycles']","['follitropin delta', 'follitropin alfa', 'recombinant FSH', 'follitropin delta or alfa']","['incidences of moderate/severe OHSS', 'risk of moderate/severe OHSS', 'moderate/severe OHSS and/or preventive interventions', 'overall OHSS risk']","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1326.0,0.116118,"On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. ","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'IVI-RMA Seville, Avda. República Argentina 58, Seville, ES-41011, Spain; Departamento de Cirugía, Universidad de Sevilla, Avda. Sánchez Pizjuan S/N, Seville, ES-41009, Spain; Departamento de Biología Molecular e Ingeniería Bioquímica, Universidad Pablo de Olavide, Seville ES-41013, Spain. Electronic address: manuel.fernandez@ivirma.com.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Visnova', 'Affiliation': 'IVF CUBE SE, Prague 160 00, Czech Republic.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Yuzpe', 'Affiliation': 'Olive Fertility Centre, Vancouver V5Z 3X7, Canada.'}, {'ForeName': 'Bjarke Mirner', 'Initials': 'BM', 'LastName': 'Klein', 'Affiliation': 'Global Biometrics, Ferring Pharmaceuticals, Copenhagen 2300, Denmark.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mannaerts', 'Affiliation': 'Science and Medicine, Ferring Pharmaceuticals, Copenhagen 2300, Denmark.'}, {'ForeName': 'Joan-Carles', 'Initials': 'JC', 'LastName': 'Arce', 'Affiliation': 'Ferring Pharmaceuticals, US Development, Parsippany, NJ 07054, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2018.12.032'] 1227,31685078,Providing objective feedback in supervision in motivational interviewing: results from a randomized controlled trial.,"BACKGROUND The effects of the use of objective feedback in supervision on the supervisory relationship and skill acquisition is unknown. AIMS The objective of this study was to evaluate the effects of two different types of objective feedback provided during supervision in motivational interviewing (MI) on: (a) the supervisory relationship, including potential feelings of discomfort/distress, provoked by the supervision sessions, and (b) the supervisees' skill acquisition. METHOD Data were obtained from a MI dissemination study conducted in five county councils across five county councils across Sweden. All 98 practitioners recorded sessions with standardized clients and were randomized to either systematic feedback based on only the behavioral component of a feedback protocol, or systematic feedback based on the entire protocol. RESULTS The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures. CONCLUSIONS Objective feedback does not seem to negatively affect either the supervisor-supervisee working alliance or the supervisees' supervision experience. The observed differences in MI skill acquisition were small, and constructive replications are needed to ascertain the mode and complexity of feedback that optimizes practitioners' learning, while minimizing the sense of discomfort and distress.",2020,"The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures. ","['All 98 practitioners recorded sessions with standardized clients', 'Data were obtained from a MI dissemination study conducted in five county councils across five county councils across Sweden']","['objective feedback provided during supervision in motivational interviewing (MI', 'systematic feedback based on only the behavioral component of a feedback protocol, or systematic feedback based on the entire protocol']",['MI skill acquisition'],"[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}]",[],98.0,0.0497211,"The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures. ","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beckman', 'Affiliation': 'Centre for Psychiatric Research, Karolinska Institutet, and Stockholm Health Care Services, Stockholm County Council, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Forsberg', 'Affiliation': 'MIC Lab AB, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindqvist', 'Affiliation': 'Centre for Psychiatric Research, Karolinska Institutet, and Stockholm Health Care Services, Stockholm County Council, Sweden.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000687'] 1228,31682682,Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.,"Importance Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity. Objective To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss. Design, Setting, and Participants This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention. Interventions Participants randomized to the GMV group (n = 136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n = 127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits). Main Outcomes and Measures Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions. Results Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P = .44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period. Conclusions and Relevance In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes. Trial Registration ClinicalTrials.gov identifier: NCT01973972.",2019,"The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period. ","['Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention', '2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina', '60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black', '2 Diabetes', 'Patients With Type', '263 participants (mean [SD] age', 'persons with diabetes']","['GMV', 'WM/GMV', 'low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention', 'Intensive Weight Management vs Group Medical Visits', 'Group Medical Visits', 'counseling about diabetes-related topics with medication optimization', 'GMVs combined with intensive weight management (WM']","['HbA1c level', 'weight loss and improve glycemia', 'HbA1c level, hypoglycemic events, diabetes medication effect score, and weight', 'glycated hemoglobin (HbA1c) level', 'hypoglycemic events, diabetes medication intensity, and weight loss', 'baseline HbA1c level', 'weight loss', 'hypoglycemic events', 'BMI']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0454851', 'cui_str': 'Durham (geographic location)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",263.0,0.125306,"The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P < .001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period. ","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville Health Care Center, Department of Veterans Affairs, Greenville, North Carolina.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Anna Barton', 'Initials': 'AB', 'LastName': 'Bradley', 'Affiliation': 'Bon Secours Health System, Richmond, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.4802'] 1229,31465818,Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up.,"OBJECTIVE The aim of this split-mouth, randomized, controlled clinical trial was to evaluate the efficacy of resin infiltration in controlling the progression of non-cavitated proximal lesions in primary molars after two-years follow-up. METHODS Fifty healthy children presenting at least two primary molars with proximal lesion detected radiographically (in the inner half of enamel or the outer third of dentin) were included in the study. The proximal lesions were randomly allocated into resin infltration + flossing (test group) or flossing (control group). All patients received oral hygiene instructions for daily brushing with fluoride toothpaste (1100 ppmF) and flossing. The proportion of caries progression was compared using the McNemar test. The main outcome after 2-years, caries progression in the radiography was assessed by pair-wise reading by an independent examiner who was blind regarding the treatment. RESULTS The sample comprised 28 (56%) girls and 22 (44%) boys with a defs of 7,3 (SD = 6,5), mainly of moderate (46%) to high (48%) caries risk. Results after one year were published previously. After 2-years, 29 (58%) patients were assessed. Caries progression was observed in 24.1% (7/29) of the test lesions, compared with 55.2% (16/29) of the control lesions (p = 0.012). The therapeutic effect was 31.1% and the relative risk reduction (RRR) was 56.3%. Eigth lesions from the control group and two lesions from the test group progressed to the inner third of dentin and were restored. CONCLUSIONS In conclusion, resin infiltration was more efficacious in controlling proximal caries lesions in primary molars than non-invasive approach alone. CLINICAL SIGNIFICANCE The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.",2019,"The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.","['Fifty healthy children presenting at least two primary molars with proximal lesion detected radiographically (in the inner half of enamel or the outer third of dentin) were included in the study', 'primary molars', 'The sample comprised 28 (56%) girls and 22 (44%) boys with a defs of 7,3 (SD\u2009=\u20096,5), mainly of moderate (46%) to high (48%) caries risk', 'primary molars after two-years follow-up']","['resin infltration\u2009+\u2009flossing (test group) or flossing (control group', 'oral hygiene instructions', 'fluoride toothpaste (1100ppmF) and flossing', 'resin infiltration']","['Caries progression', 'proximal caries lesions', 'proportion of caries progressions', 'relative risk reduction (RRR', 'therapeutic effect', 'caries progression']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C4041253', 'cui_str': 'Inner half of enamel'}, {'cui': 'C4038556', 'cui_str': 'Outer third of dentin (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0054282', 'cui_str': 'tribufos'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1527144'}]",50.0,0.0686572,"The results indicate that resin infiltration was an efficacious method in controlling proximal caries lesions in primary molars after 2 years, even in patients with high caries risk, reaffirming the results of 1-year follow-up.","[{'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Jorge', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, RJ, Brazil; Dental School, Faculty of Arthur Sá Earp Neto, Petrópolis, RJ, Brazil.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Ammari', 'Affiliation': 'Department of Specific Training, School of Dentistry, Universidade Federal Fluminense - UFF, Nova Friburgo, RJ, Brazil; Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Soviero', 'Affiliation': 'Department of Preventive and Community Dentistry, School of Dentistry, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, RJ, Brazil; Dental School, Faculty of Arthur Sá Earp Neto, Petrópolis, RJ, Brazil. Electronic address: verasoviero@gmail.com.'}, {'ForeName': 'I P R', 'Initials': 'IPR', 'LastName': 'Souza', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Universidade Federal do Rio de Janeiro, UFRJ, Rio de Janeiro, RJ, Brazil.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103184'] 1230,31475572,Risk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes.,"BACKGROUND The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. METHODS In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. RESULTS Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; P interaction =0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; P interaction =0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). CONCLUSIONS The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). ","['Of 18\u2009924 participants followed for a median of 2.8 years, 11\u2009935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions', 'patients with low-density lipoprotein cholesterol ≥70', 'Acute Coronary Syndromes', 'patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy', 'patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events']","['lipid-lowering therapies', 'placebo', 'Alirocumab', 'mg/dL or non-high-density lipoprotein cholesterol ≥100', 'alirocumab or placebo']","['absolute risk reduction for major adverse cardiovascular events with alirocumab', 'American College of Cardiology/American Heart Association risk category', 'adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina', 'Major adverse cardiovascular events', 'adverse cardiovascular events']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]","[{'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}]",,0.0447947,"The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; P interaction =0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; P interaction =0.661). ","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.T.R., R.D.L.).'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (Q.H.L., M.J.L.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, Toronto, Canada (S.G.G.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford University Medical Center, CA (R.A.H.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Center, the Netherlands (J.W.J.).'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Fundación Oftalmológica de Santander (FOSCAL), Medical School (UDES), Floridablanca, Colombia (P.L.-J.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (M.T.R., R.D.L.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (Q.H.L., M.J.L.).'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Moriarty', 'Affiliation': 'University of Kansas Medical Center, Kansas City, MO (P.M.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York (SUNY) Downstate Medical Center, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vogel', 'Affiliation': 'University of Colorado, Aurora (R.V., G.G.S.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Montpellier, France (M.T.B.-D.).'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), Institut National de la Santé et de la Recherche Médicale (INSERM) U1148, France (P.G.S.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'University of Colorado, Aurora (R.V., G.G.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042551'] 1231,32407901,A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.,"OBJECTIVES Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity. DESIGN This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019. RESULTS The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive. CONCLUSIONS To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005'] 1232,11668653,The semantic interference effect in the picture-word paradigm: an event-related fMRI study employing overt responses.,"We used event-related functional magnetic resonance imaging (fMRI) to investigate neural responses associated with the semantic interference (SI) effect in the picture-word task. Independent stage models of word production assume that the locus of the SI effect is at the conceptual processing level (Levelt et al. [1999]: Behav Brain Sci 22:1-75), whereas interactive models postulate that it occurs at phonological retrieval (Starreveld and La Heij [1996]: J Exp Psychol Learn Mem Cogn 22:896-918). In both types of model resolution of the SI effect occurs as a result of competitive, spreading activation without the involvement of inhibitory links. These assumptions were tested by randomly presenting participants with trials from semantically-related and lexical control distractor conditions and acquiring image volumes coincident with the estimated peak hemodynamic response for each trial. Overt vocalization of picture names occurred in the absence of scanner noise, allowing reaction time (RT) data to be collected. Analysis of the RT data confirmed the SI effect. Regions showing differential hemodynamic responses during the SI effect included the left mid section of the middle temporal gyrus, left posterior superior temporal gyrus, left anterior cingulate cortex, and bilateral orbitomedial prefrontal cortex. Additional responses were observed in the frontal eye fields, left inferior parietal lobule, and right anterior temporal and occipital cortex. The results are interpreted as indirectly supporting interactive models that allow spreading activation between both conceptual processing and phonological retrieval levels of word production. In addition, the data confirm that selective attention/response suppression has a role in resolving the SI effect similar to the way in which Stroop interference is resolved. We conclude that neuroimaging studies can provide information about the neuroanatomical organization of the lexical system that may prove useful for constraining theoretical models of word production.",2001,"Additional responses were observed in the frontal eye fields, left inferior parietal lobule, and right anterior temporal and occipital cortex.",['1999'],['functional magnetic resonance imaging (fMRI'],"['semantic interference effect', 'reaction time (RT) data', 'semantic interference (SI) effect', 'frontal eye fields, left inferior parietal lobule, and right anterior temporal and occipital cortex', 'left mid section of the middle temporal gyrus, left posterior superior temporal gyrus, left anterior cingulate cortex, and bilateral orbitomedial prefrontal cortex']",[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C3498745', 'cui_str': 'Frontal Eye Fields'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C3811911', 'cui_str': 'Cuneus'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C3850033', 'cui_str': 'Left Posterior Superior Temporal Gyrus'}, {'cui': 'C0441998', 'cui_str': 'Left anterior (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.0379348,"Additional responses were observed in the frontal eye fields, left inferior parietal lobule, and right anterior temporal and occipital cortex.","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'de Zubicaray', 'Affiliation': 'Centre for Magnetic Resonance, The University of Queensland, QLD, Australia. greig.dezubicaray@cmr.uq.edu.au'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'McMahon', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Muthiah', 'Affiliation': ''}]",Human brain mapping,[] 1233,30663606,"Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial.","BACKGROUND Patients with Parkinson's disease chronically treated with levodopa commonly have delayed or unpredictable onset of its benefits after oral intake. In this study, we assessed the safety and efficacy of CVT-301, a self-administered levodopa oral inhalation powder, for the treatment of patients with Parkinson's disease during off periods. METHODS In this randomised, double-blind, placebo-controlled, phase 3 trial, patients were recruited at 65 sites in Canada, Poland, Spain, and the USA. Eligible participants were patients with Parkinson's disease aged 30-85 years, who had daily off periods of 2 h or longer and showed an improvement of 25% or greater in the Unified Parkinson's Disease Rating Scale (UPDRS) motor score from off to on state after use of an oral levodopa plus a dopa-decarboxylase inhibitor combination. Patients were assigned (1:1:1) with a computer-generated randomisation code, in fixed blocks of six, to either CVT-301 60 mg, CVT-301 84 mg, or placebo. Spirometry results and modified Hoehn and Yahr disease stage at screening were used for stratification of treatment groups. Patients, the sponsor, and site personnel were masked to treatment assignment. Each study dose consisted of two capsules administered with an inhaler. Patients were instructed to use the study drug as needed for off periods, and could self-administer up to five doses per day. The primary endpoint was the change in UPDRS motor score from predose to 30 min postdose, assessed at week 12 during an in-clinic off period, in the CVT-301 84 mg group compared with the placebo group. Analysis was by intention to treat. Safety was assessed in all patients who received at least one dose of experimental treatment. This trial is registered with ClinicalTrials.gov, number NCT02240030. FINDINGS Between Dec 4, 2014, and Aug 26, 2016, 351 patients were enrolled and randomly assigned to receive CVT-301 60 mg (115 patients), CVT-301 84 mg (120 patients), or placebo (116 patients). Of these, 339 received the assigned study treatment (CVT-301 60 mg, n=113; CVT-301 84 mg, n=114; placebo, n=112) and 290 completed the study (CVT-301 60 mg, n=96; CVT-301 84 mg, n=97; placebo, n=97). The least-squares mean difference in UPDRS motor score change from predose to 30 min postdose was -5·91 (SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83 (1·51; -12·79 to -6·87) for the CVT-301 84 mg group (between-group difference -3·92 [-6·84 to -1·00]; p=0·0088). Treatments were safe and well tolerated. Severe adverse events were reported by 2 (2%) of 112 patients in the placebo group, 7 (6%) of 113 in the CVT-301 60 mg group, and 5 (4%) of 114 in the CVT-301 84 mg group, with no severe adverse event occurring in more than one patient in any treatment group. 11 (3%) of 339 patients had 19 serious adverse events (three [3%] of 112 patients in placebo, six [5%] of 113 in CVT-301 60 mg, and two [2%] of 114 in CVT-301 84 mg). Of these, hypotension and atrial fibrillation were assessed by investigators to be possibly related to the study drug. INTERPRETATION CVT-301 can improve UPDRS motor scores of patients with Parkinson's disease during in-clinic off periods, with few severe or serious adverse events. The long-term safety and efficacy of CVT-301 need to be investigated in future studies. FUNDING Acorda Therapeutics.",2019,"(SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83","['patients were recruited at 65 sites in Canada, Poland, Spain, and the USA', 'Between Dec 4, 2014, and Aug 26, 2016, 351 patients', ""Patients with Parkinson's disease chronically treated with"", ""patients with Parkinson's disease"", ""Eligible participants were patients with Parkinson's disease aged 30-85 years, who had daily off periods of 2 h or longer and showed an improvement of 25% or greater in the Unified Parkinson's Disease Rating Scale (UPDRS) motor score from off to on state after use of an oral levodopa plus a dopa-decarboxylase inhibitor combination"", ""patients with Parkinson's disease during off periods""]","['placebo', 'CVT-301, a self-administered levodopa oral inhalation powder', 'CVT-301 60 mg, CVT-301 84 mg, or placebo', 'levodopa', 'CVT-301', 'CVT-301 (levodopa inhalation powder']","['safe and well tolerated', 'safety and efficacy', 'Severe adverse events', 'motor function', 'UPDRS motor score change', '19 serious adverse events', 'change in UPDRS motor score', 'hypotension and atrial fibrillation', 'UPDRS motor scores', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0598272', 'cui_str': 'DOPA Decarboxylase Inhibitors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",351.0,0.572548,"(SE 1·50, 95% CI -8·86 to -2·96) for the placebo group and -9·83","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Department of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, USA. Electronic address: plewitt1@hfhs.org.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida College of Medicine, Tampa, FL, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Pourcher', 'Affiliation': 'Faculty of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Lopez-Manzanares', 'Affiliation': 'University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Waters', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzínska', 'Affiliation': 'Faculty of Medicine, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedkov', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Batycky', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Ardsley, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30405-8'] 1234,29217375,"Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials.","BACKGROUND A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings. METHODS We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Vaccinations were given intramuscularly on days 1 and 29. The primary objective was safety and immunogenicity of the ZPIV candidate. We recorded adverse events and Zika virus envelope microneutralisation titres up to day 57. These trials are registered at ClinicalTrials.gov, numbers NCT02963909, NCT02952833, and NCT02937233. FINDINGS We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017. One was excluded and 67 participants received two injections of Zika vaccine (n=55) or placebo (n=12). The vaccine caused only mild to moderate adverse events. The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]). By day 57, 52 (92%) of vaccine recipients had seroconverted (microneutralisation titre ≥1:10), with peak geometric mean titres seen at day 43 and exceeding protective thresholds seen in animal studies. INTERPRETATION The ZPIV candidate was well tolerated and elicited robust neutralising antibody titres in healthy adults. FUNDING Departments of the Army and Defense and National Institute of Allergy and Infectious Diseases.",2018,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","['We enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017', 'healthy adults', 'human beings']","['placebo', 'purified formalin-inactivated Zika virus vaccine (ZPIV', 'Zika vaccine', 'ZPIV with aluminium hydroxide adjuvant', 'computer-generated list to receive 5 μg ZPIV or saline placebo']","['tenderness', 'adverse events and Zika virus envelope microneutralisation titres', 'malaise', 'headache', 'safety and immunogenicity']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",68.0,0.549153,"The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]).","[{'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sondergaard', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tennant', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Kosel', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center and Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Meyer', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brien', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Crowell', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Blazevic', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Mosby', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Larocca', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Bricault', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Basil', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tonwe', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hoft', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, Saint Louis, MO, USA; Saint Louis VA Medical Center, Saint Louis, MO, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.mil@mail.mil.'}]","Lancet (London, England)",['10.1016/S0140-6736(17)33106-9'] 1235,30744491,"Physical, cognitive and psychosocial effects of telerehabilitation-based motor imagery training in people with multiple sclerosis: A randomized controlled pilot trial.","INTRODUCTION Motor imagery training delivered at home via telerehabilitation is a novel rehabilitation concept. The aim was to investigate the effects of telerehabilitation-based motor imaging training (Tele-MIT) on gait, balance and cognitive and psychosocial outcomes in people with multiple sclerosis (pwMS). METHODS This randomized, controlled pilot trial included pwMS and healthy individuals. pwMS were randomly divided into two groups, intervention and control. The intervention group received Tele-MIT twice a week for 8 weeks. The control group was a wait-list group without any additional specific treatment. Healthy participants served as a baseline comparison. The Dynamic Gait Index, used to assess dynamic balance during walking, was the primary outcome. Secondary outcomes included assessments of walking speed, endurance and perceived ability, balance performance assessed by a computerized posturography device, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life. RESULTS Baseline comparisons with healthy individuals revealed that motor imagery abilities were preserved in pwMS ( p  > 0.05). The intervention group exhibited significant improvements in dynamic balance during walking ( p  = 0.002), walking speed ( p  = 0.007), perceived walking ability ( p  = 0.008), balance confidence ( p  = 0.002), most cognitive functions ( p  = 0.001-0.008), fatigue ( p  = 0.001), anxiety ( p  = 0.001), depression ( p  = 0.005) and quality of life ( p  = 0.002). No significant changes were observed in the control group in any of the outcome measures ( p  > 0.05). DISCUSSION Tele-MIT is a novel method that proved feasible and effective in improving dynamic balance during walking, walking speed and perceived walking ability, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life in pwMS.",2020,"The intervention group exhibited significant improvements in dynamic balance during walking ( p = 0.002), walking speed ( p = 0.007), perceived walking ability ( p = 0.008), balance confidence ( p = 0.002), most cognitive functions ( p = 0.001-0.008), fatigue ( p = 0.001), anxiety ( p = 0.001), depression ( p = 0.005) and quality of life ( p = 0.002).","['Healthy participants', 'pwMS and healthy individuals', 'people with multiple sclerosis', 'people with multiple sclerosis (pwMS']","['Tele-MIT', 'telerehabilitation-based motor imagery training', 'telerehabilitation-based motor imaging training (Tele-MIT', 'wait-list group without any additional specific treatment']","['cognitive functions', 'walking speed', 'fatigue', 'dynamic balance during walking, walking speed and perceived walking ability, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life in pwMS', 'depression', 'gait, balance and cognitive and psychosocial outcomes', 'motor imagery abilities', 'Physical, cognitive and psychosocial effects', 'dynamic balance during walking', 'anxiety', 'Dynamic Gait Index', 'quality of life', 'assessments of walking speed, endurance and perceived ability, balance performance assessed by a computerized posturography device, balance confidence, cognitive functions, fatigue, anxiety, depression and quality of life', 'balance confidence', 'perceived walking ability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}]",,0.0614882,"The intervention group exhibited significant improvements in dynamic balance during walking ( p = 0.002), walking speed ( p = 0.007), perceived walking ability ( p = 0.008), balance confidence ( p = 0.002), most cognitive functions ( p = 0.001-0.008), fatigue ( p = 0.001), anxiety ( p = 0.001), depression ( p = 0.005) and quality of life ( p = 0.002).","[{'ForeName': 'Turhan', 'Initials': 'T', 'LastName': 'Kahraman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Asiye Tuba', 'Initials': 'AT', 'LastName': 'Ozdogar', 'Affiliation': 'Institute of Health Sciences, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Zumrut', 'Initials': 'Z', 'LastName': 'Gedik', 'Affiliation': 'Department of Psychology, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Egemen', 'Initials': 'E', 'LastName': 'Idiman', 'Affiliation': 'Department of Neurology, Dokuz Eylül University, Izmir, Turkey.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18822355'] 1236,30680611,The effects of lutein and zeaxanthin on resting state functional connectivity in older Caucasian adults: a randomized controlled trial.,"The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health. A growing literature suggests cognitive benefits as well, particularly in older adults. The present randomized controlled trial sought to investigate the effects of L and Z on brain function using resting state functional magnetic resonance imaging (fMRI). It was hypothesized that L and Z supplementation would (1) improve intra-network integrity of default mode network (DMN) and (2) reduce inter-network connectivity between DMN and other resting state networks. 48 community-dwelling older adults (mean age = 72 years) were randomly assigned to receive a daily L (10 mg) and Z (2 mg) supplement or a placebo for 1 year. Resting state fMRI data were acquired at baseline and post-intervention. A dictionary learning and sparse coding computational framework, based on machine learning principles, was used to investigate intervention-related changes in functional connectivity. DMN integrity was evaluated by calculating spatial overlap rate with a well-established DMN template provided in the neuroscience literature. Inter-network connectivity was evaluated via time series correlations between DMN and nine other resting state networks. Contrary to expectation, results indicated that L and Z significantly increased rather than decreased inter-network connectivity (Cohen's d = 0.89). A significant intra-network effect on DMN integrity was not observed. Rather than restoring what has been described in the available literature as a ""youth-like"" pattern of intrinsic brain activity, L and Z may facilitate the aging brain's capacity for compensation by enhancing integration between networks that tend to be functionally segregated earlier in the lifespan.",2020,The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health.,"['older Caucasian adults', '48 community-dwelling older adults (mean age\u2009=\u200972\xa0years', 'older adults']","['daily L (10\xa0mg) and Z (2\xa0mg) supplement or a placebo', 'L and Z', 'resting state functional magnetic resonance imaging (fMRI', 'lutein and zeaxanthin', 'carotenoids lutein (L) and zeaxanthin']","['intra-network integrity of default mode network (DMN) and (2) reduce inter-network connectivity', 'inter-network connectivity', 'DMN integrity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",48.0,0.151333,The carotenoids lutein (L) and zeaxanthin (Z) accumulate in retinal regions of the eye and have long been shown to benefit visual health.,"[{'ForeName': 'Cutter A', 'Initials': 'CA', 'LastName': 'Lindbergh', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Psychiatry and Department of Biomedical Engineering, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Computer Science, 420 Boyd Graduate Studies Research Center, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Mewborn', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Antonio N', 'Initials': 'AN', 'LastName': 'Puente', 'Affiliation': 'Psychiatry and Behavioral Sciences, George Washington University, 2120 L St., Suite 600, Washington D.C., 22307, USA.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Terry', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 79/96 Thirteenth Street, Charlestown Navy Yard, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Renzi-Hammond', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Billy R', 'Initials': 'BR', 'LastName': 'Hammond', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA.'}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Computer Science, 420 Boyd Graduate Studies Research Center, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'L Stephen', 'Initials': 'LS', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, University of Georgia, Psychology Building, Athens, GA, 30602, USA. lsmiller@uga.edu.'}]",Brain imaging and behavior,['10.1007/s11682-018-00034-y'] 1237,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes. RESEARCH QUESTION The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people. METHOD A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate. RESULTS AND CONCLUSION Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020'] 1238,32408117,"Effects of saffron supplementation on glycemia and inflammation in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial study.","BACKGROUND New evidence indicates that overproduction of pro-inflammatory cytokines is responsible for the development of diabetes difficulties. Some herbals such as saffron, may control inflammation and improve the hyperglycemic states in diabetic patients. Therefore, this investigation aimed to assess the effects of saffron supplementation on fasting glucose and inflammatory markers levels in patients with type2 diabetes mellitus (T2DM). METHODS In this randomized double-blind, placebo-controlled clinical trial, 60 T2DM patients were randomly assigned into two groups as saffron and placebo (n = 30) receiving 100 mg/day saffron powder or starch capsules (1 capsule) for a duration of 8 weeks. Fasting blood sample was collected at baseline and at the end of the intervention. Fasting blood glucose (FBG) was immediately analyzed by the auto-analyzer. The serum level of Interleukin -6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10) were measured using ELISA assay by laboratory kits. Also, Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level. RESULTS Saffron supplementation significantly decreased the FBG levels within 8 weeks compared to placebo (130.93 ± 21.21 vs 135.13 ± 23.03 mg/dl, P = 0.012). Moreover, the serum level of TNF-α notably reduced in the saffron group compared to the placebo group (114.40 ± 24.28 vs 140.90 ± 25.49 pg/ml, P < 0.001). Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014). CONCLUSION In our study, it was indicated that saffron modulates glucose levels as well as inflammation status in T2DM patients through decreasing the expressions levels of some inflammatory mediators. Also, further investigations are necessary to confirm the positive effects of saffron as a complementary therapy for T2DM patients.",2020,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014). ","['60 T2DM patients', 'patients with type 2 diabetes mellitus', 'patients with type2 diabetes mellitus (T2DM', 'diabetic patients', 'T2DM patients']","['saffron supplementation', 'saffron and placebo (n\xa0=\xa030) receiving 100\xa0mg/day saffron powder or starch capsules', 'placebo']","['IL-6 mRNA levels', 'hyperglycemic states', 'glycemia and inflammation', 'Real-time quantitative reverse transcription (RT-PCR) assay measured the expression level of TNF-α, IL-6, and IL-10 at the mRNA level', 'FBG levels', 'expressions of TNF-α', 'fasting glucose and inflammatory markers levels', 'Fasting blood glucose (FBG', 'serum level of Interleukin\xa0-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), and Interleukin-10 (IL-10', 'serum level of TNF-α', 'Fasting blood sample']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.491142,"Also, saffron supplementation significantly down-regulated the expressions of TNF-α (P = 0.035) and IL-6 mRNA levels (P = 0.014). ","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mobasseri', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ostadrahimi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aynaz', 'Initials': 'A', 'LastName': 'Tajaddini', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Pharmacology School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Student Research Committee, Department of Cellular and Molecular Nutrition, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Students Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Houshyar', 'Affiliation': 'Department of Medicine, Endocrine Section, Endocrine Research Center, Tabriz University of Medical Sciences, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Roshanravan', 'Affiliation': 'Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: roshanravann@tbzmed.ac.ir.'}, {'ForeName': 'Naimeh Mesri', 'Initials': 'NM', 'LastName': 'Alamdari', 'Affiliation': 'Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: mesrialamdari.n@tak.iums.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.031'] 1239,32408011,"Cold versus hot adenoidectomy: A prospective, randomized controlled trial.","OBJECTIVE Adenoidectomy can be performed using the cold method (mainly adenoid curettes) or the hot method (suction diathermy). Both techniques have similar intra and postoperative outcomes. However, the long-term clinical outcome of improving sleep disorder symptoms has not been well established. The objective of this study was to compare outcomes of hot method and cold method adenoidectomy one year following the surgery. STUDY DESIGN A prospective, randomized, single-blinded study of children under age 16 years who underwent adenoidectomy during the years 2014-2017. Patients were randomized to hot or cold adenoidectomy techniques. SETTING A tertiary health care referral center. SUBJECTS AND METHODS The final analysis included 58 children, mean age 5.9 years (range 1.2-15). The primary outcome was change in the Pediatric Sleep Questionnaire (PSQ) scores one month and one year after surgery. The secondary outcome was complication rate. RESULTS Clinical and demographic parameters were similar between the patients in the hot method group (n = 30) and the cold method group (n = 28). Adenoid size and estimated bleeding were similar between the groups. At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54). Improvement in PSQ scores was greater following hot than cold adenoidectomy at one year after surgery (+0.31 points vs. +0.22 points, p = 0.009). CONCLUSION Hot adenoidectomy is associated with better outcome than the cold technique, as reflected by PSQ scores one year after the surgery.",2020,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","['A tertiary health care referral center', 'children under age 16 years who underwent adenoidectomy during the years 2014-2017', '58 children, mean age 5.9 years (range 1.2-15']","['hot method and cold method adenoidectomy', 'Cold versus hot adenoidectomy', 'cold adenoidectomy', 'Hot adenoidectomy', 'hot or cold adenoidectomy techniques']","['sleep disorder symptoms', 'Pediatric Sleep Questionnaire (PSQ) scores', 'complication rate', 'PSQ scores', 'PSQ score', 'Adenoid size and estimated bleeding']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0426463', 'cui_str': 'Adenoids size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",58.0,0.101449,"At one month after surgery, PSQ score was improved by a mean + 0.31 in the hot method group compared to +0.32 in the cold method group (p = 0.54).","[{'ForeName': 'Shorook', 'Initials': 'S', 'LastName': ""Na'ara"", 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Sayegh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Nassar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Shinnawi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gil', 'Affiliation': 'The Laboratory for Applied Cancer Research, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel; Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Gordin', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, The Head and Neck Center, Rambam Healthcare Campus, Clinical Research Institute at Rambam, Rappaport Institute of Medicine and Research, The Technion, Israel Institute of Technology, Haifa, Israel. Electronic address: a_gordin@rambam.health.gov.il.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110087'] 1240,32408065,Spending the night next to a router - Results from the first human experimental study investigating the impact of Wi-Fi exposure on sleep.,"BACKGROUND The use of wireless telecommunication systems such as wireless fidelity (Wi-Fi)-enabled devices has steadily increased in recent years. There are persistent concerns that radiofrequency electromagnetic field (RF-EMF) exposure might affect health. Possible effects of RF-EMF exposure on human sleep were examined with regard to mobile phones and base stations, but not with regard to Wi-Fi exposure. OBJECTIVES The present double-blind, sham-controlled, randomized, fully counterbalanced cross-over study addressed for the first time the question whether a whole night Wi-Fi exposure has an effect on sleep. METHODS Thirty-four healthy young male subjects (mean ± SD: 24.1 ± 2.9 years) spent five nights in the sleep laboratory. A screening and adaptation night was followed by two experimental nights. Each of the experimental nights was preceded by a baseline night. Sleep was evaluated at the subjective level by a questionnaire and at the objective level (macro- and microstructure) by polysomnography. Either 2.45 GHz Wi-Fi (max psSAR10g of 6.4 mW/kg) or sham signals were delivered by a newly developed head exposure facility. RESULTS Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep. Analyses of the microstructure of sleep revealed a reduction in global EEG power in the alpha frequency band (8.00-11.75 Hz) during NREM sleep under acute Wi-Fi exposure compared to sham. DISCUSSION The results of the present human experimental study are well in line with several other neurophysiological studies showing that acute RF-EMF exposure has no effect on the macrostructure of sleep. The slight physiological changes in EEG power observed under Wi-Fi exposure are neither reflected in the subjective assessment of sleep nor at the level of objective measurements. The present results are not indicative of a sleep disturbing effect of Wi-Fi exposure.",2020,"RESULTS Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.",['Thirty-four healthy young male subjects (mean\xa0±\xa0SD: 24.1\xa0±\xa02.9 years) spent five nights in the sleep laboratory'],"['GHz Wi-Fi', 'RF-EMF exposure', 'radiofrequency electromagnetic field (RF-EMF']","['subjective sleep parameters', 'global EEG power', 'Sleep']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0556961', 'cui_str': 'GHz'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",34.0,0.0200575,"RESULTS Results showed no statistically significant acute effects of a whole-night Wi-Fi exposure on subjective sleep parameters as well as on parameters characterizing the macrostructure of sleep.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bueno-Lopez', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Hirtl', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Competence Center for Sleep Medicine, Berlin, Germany.'}]",International journal of hygiene and environmental health,['10.1016/j.ijheh.2020.113550'] 1241,30517731,Adopting a Mediterranean-Style Eating Pattern with Different Amounts of Lean Unprocessed Red Meat Does Not Influence Short-Term Subjective Personal Well-Being in Adults with Overweight or Obesity.,"Background Reducing red meat intake is commonly recommended. Limited observational studies suggest that healthy eating patterns with red meat are associated with improved quality of life. Objective The secondary objectives of this randomized crossover controlled-feeding trial were to assess the effects of following a Mediterranean-style eating pattern (Med-Pattern) with different amounts of red meat on indexes of personal well-being (i.e., perceived quality of life, mood, and sleep) in overweight or obese adults. We hypothesized that following a Med-Pattern would improve these outcomes, independent of red meat intake amount. Methods Forty-one participants [aged 46 ± 2 y; body mass index (kg/m2): 30.5 ± 0.6; n = 28 women, n = 13 men) were provided Med-Pattern foods for two 5-wk periods separated by 4 wk of self-selected eating. The Med-Red Pattern contained ∼500 g/wk (typical US intake), and the Med-Control Pattern contained ∼200 g/wk (commonly recommended intake in heart-healthy eating patterns) of lean, unprocessed beef or pork compensated with mainly poultry and dairy. Baseline and postintervention outcomes measured were perceived quality of life via the MOS 36-Item Short-Form Health Survey, version 2 (SF-36v2), daily mood states via the Profile of Mood States (POMS), sleep perceptions via the Pittsburgh Sleep Quality Index, and sleep patterns via actigraphy. Data were analyzed via a doubly repeated-measures ANOVA adjusted for age, sex, and body mass at each time point. Results Following a Med-Pattern did not change domains of physical health, mental health, total mood disturbances, sleep perceptions, and sleep patterns but improved subdomains of physical health role limitations (SF-36v2: 93.6-96.7%; P = 0.038), vitality (SF-36v2: 57.9-63.0%; P = 0.020), and fatigue (POMS: 2.9-2.5 arbitrary units; P = 0.039). There were no differences between the Med-Red and Med-Control Patterns (time × pattern, P-interaction > 0.05). Conclusion Following a Med-Pattern, independent of lean, unprocessed red meat intake, may not be an effective short-term strategy to meaningfully improve indexes of personal well-being in adults who are overweight or obese. This trial was registered at clinicaltrials.gov as NCT02573129.",2018,"did not change domains of physical health, mental health, total mood disturbances, sleep perceptions, and sleep patterns but improved subdomains of physical health role limitations (SF-36v2: 93.6-96.7%; P = 0.038), vitality (SF-36v2: 57.9-63.0%; P = 0.020), and fatigue (POMS: 2.9-2.5 arbitrary units; P = 0.039).","['adults who are overweight or obese', 'overweight or obese adults', 'Adults with Overweight or Obesity', 'Methods\n\n\nForty-one participants [aged 46\xa0±\xa02 y; body mass index (kg/m2): 30.5\xa0±\xa00.6; n\xa0=\xa028 women, n\xa0=\xa013 men']","['Lean Unprocessed Red Meat', 'Mediterranean-style eating pattern (Med-Pattern) with different amounts of red meat']","['indexes of personal well-being (i.e., perceived quality of life, mood, and sleep', 'quality of life', 'quality of life via the MOS 36-Item Short-Form Health Survey, version 2 (SF-36v2), daily mood states via the Profile of Mood States (POMS), sleep perceptions via the Pittsburgh Sleep Quality Index, and sleep patterns via actigraphy', 'physical health, mental health, total mood disturbances, sleep perceptions, and sleep patterns but improved subdomains of physical health role limitations', 'Med-Red and Med-Control Patterns']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",28.0,0.155177,"did not change domains of physical health, mental health, total mood disturbances, sleep perceptions, and sleep patterns but improved subdomains of physical health role limitations (SF-36v2: 93.6-96.7%; P = 0.038), vitality (SF-36v2: 57.9-63.0%; P = 0.020), and fatigue (POMS: 2.9-2.5 arbitrary units; P = 0.039).","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': ""O'Connor"", 'Affiliation': 'Departments of Nutrition Science.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Biberstine', 'Affiliation': 'Departments of Nutrition Science.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Paddon-Jones', 'Affiliation': 'Department of Nutrition and Metabolism, University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Schwichtenberg', 'Affiliation': 'Human Development and Family Studies, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Departments of Nutrition Science.'}]",The Journal of nutrition,['10.1093/jn/nxy235'] 1242,30513030,Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial.,"Background: Respiratory distress syndrome (RDS) is one of the main causes of mortality in premature neonates. Treatment of these neonates with invasive mechanical ventilation has side effects such as chronic pulmonary diseases. Noninvasive ventilation, such as nasal continuous positive airway pressure (NCPAP) and nasal high-frequency oscillation ventilation (NHFOV), has shown to reduce the burden of chronic lung disease. NHFOV is a promising new mode of noninvasive ventilation and may reduce the need for mechanical ventilation and reduce possible complications. In this study, we hypothesized that early NHFOV would reduce the need for invasive respiratory support in comparison to NCPAP in preterm neonates with RDS. Methods: One hundred twenty-four neonates between 28 to 34 weeks of gestational age (GA) with RDS hospitalized at Imam Khomeini Hospital, Ahvaz in 2016 were included in this randomized controlled study. The primary outcomes were the failure of NHFOV and NCPAP within 72 h after birth. The secondary outcomes were the duration of invasive ventilation and possible side effects. Results: Out of 124 neonates in this study, 63 and 61 neonates were studied in the NHFOV and NCPAP groups, respectively. There were no significant differences between NHFOV (6.5%) and NCPAP (14.1%) groups in terms of rates of primary consequences ( p  = .13). However, the duration of noninvasive ventilation in NHFOV was significantly less than that of NCPAP group ( p  = .01). Conclusion: In our study group, preterm infants from 28 to 34 weeks of GA, NHFOV did not reduce the need for mechanical ventilation during the first 72 h after birth compared to NCPAP; however, the duration of noninvasive ventilation in the NHFOV group was significantly shorter.",2020,groups in terms of rates of primary consequences (p = 0.13).,"['One hundred twenty-four neonates', 'between 28 to 34\xa0weeks of gestational age (GA) with respiratory distress syndrome hospitalized at Imam Khomeini Hospital, Ahvaz in 2016', 'preterm infants with respiratory distress syndrome', 'preterm neonates with RDS', '124 neonates in this study', 'premature neonates']","['Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure', 'NCPAP', 'Noninvasive ventilation, such as nasal continuous positive airway pressure (NCPAP) and nasal high-frequency oscillation ventilation (NHFOV', 'invasive mechanical ventilation']","['need for mechanical ventilation', 'duration of invasive ventilation and possible side effects', 'NHFOV', 'failure of NHFOV and NCPAP', 'duration of noninvasive ventilation in NHFOV', 'duration of noninvasive ventilation']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}]","[{'cui': 'C0419017', 'cui_str': 'High frequency oscillatory ventilation (procedure)'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C2718088', 'cui_str': 'High-Frequency Oscillation Ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]",124.0,0.164748,groups in terms of rates of primary consequences (p = 0.13).,"[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Malakian', 'Affiliation': 'Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Bashirnezhadkhabaz', 'Affiliation': 'Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Aramesh', 'Affiliation': 'Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Dehdashtian', 'Affiliation': 'Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1555810'] 1243,30521044,Effects of Zinc Combined with Probiotics on Antibiotic-associated Diarrhea Secondary to Childhood Pneumonia.,"AIM The aim of this study was to evaluate the impact of zinc combined with probiotics (Bifico) on antibiotic-associated diarrhea (AAD) secondary to pneumonia. METHODS A total of 50 patients with AAD secondary to pneumonia were randomly divided into a probiotics group (Bifico) and a combined group (zinc combined with Bifico) and 25 pneumonia patients without AAD as the control group. Serum levels of zinc, diamine oxidase (DAO) activity, D-lactate and intestinal flora [Bifidobacterium, Escherichia coli and Bifidobacterium/E. coli (B/E) ratio] were detected before and after intervention. RESULTS The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia. Notably, the combined treatment increased the population of Bifidobacterium, while the number of E. coli was reduced, the B/E value was improved and DAO activity and D-lactate levels were markedly reduced. CONCLUSION Patients with AAD secondary to pneumonia benefit from zinc supplementation of probiotic treatment.",2019,The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia.,"['25 pneumonia patients without AAD as the control group', '50 patients with AAD secondary to pneumonia', 'Antibiotic-associated Diarrhea Secondary to Childhood Pneumonia']","['probiotics group (Bifico) and a combined group (zinc combined with Bifico', 'zinc combined with probiotics (Bifico', 'Zinc Combined with Probiotics']","['Serum levels of zinc, diamine oxidase (DAO) activity, D-lactate and intestinal flora [Bifidobacterium, Escherichia coli and Bifidobacterium/E. coli (B/E) ratio', 'number of E. coli', 'population of Bifidobacterium', 'DAO activity and D-lactate levels', 'overall efficiency']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0019587', 'cui_str': 'Histaminase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0522080', 'cui_str': 'D-lactate (substance)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",50.0,0.0297627,The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Xiang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Xiu-Qi', 'Initials': 'XQ', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Mu-Yan', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'The Medical Science Experiment Center, Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Mei-Xiong', 'Initials': 'MX', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yun', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}, {'ForeName': 'Qing-Wen', 'Initials': 'QW', 'LastName': 'Shan', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital of Guangxi Medical University, Nanning city, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy069'] 1244,31656287,Translational and Randomized Study of 5-HT3 Receptor Antagonists for Evaluation of Chemotherapy-induced Nausea and Vomiting Related Biomarkers.,"Purpose We assessed the efficacy of palonosetron (PAL) in comparison to granisetron (GRA) for the treatment of CINV using the self-assessment questionnaires. In addition, we analyzed the serum levels of emetic various biomarkers. Methods We conducted a randomized study of 70 patients naïve to chemotherapy. The primary endpoint was the late phase score on the MAT questionnaire. The plasma concentrations of the biomarkers were measured on days 1 and 3. Results There were no statistical differences in the scores on the questionnaires, but the mean values in response to PAL were higher than those in response to GRA. The value of ghrelin on day 1 was significantly higher for GRA than for PAL. Conclusions For the primary endpoint, the score of the late phase on the MAT questionnaire was not statistically different between the PAL and GRA treatment groups. Further studies are needed to clarify the role of ghrelin for the treatment of CINV. J. Med. Invest. 66 : 269-274, August, 2019.",2019,"Conclusions For the primary endpoint, the score of the late phase on the MAT questionnaire was not statistically different between the PAL and GRA treatment groups.","['70 patients naïve to chemotherapy', '66 : 269-274, August, 2019']","['GRA', 'palonosetron (PAL', '5-HT3 Receptor Antagonists', 'granisetron (GRA']","['late phase score on the MAT questionnaire', 'Nausea and Vomiting Related Biomarkers', 'plasma concentrations of the biomarkers', 'serum levels of emetic various biomarkers', 'score of the late phase on the MAT questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4521929', 'cui_str': '5-HT3 receptor antagonist'}, {'cui': 'C0061863', 'cui_str': 'Granisetron'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013973', 'cui_str': 'Emetic Agents'}]",70.0,0.0194692,"Conclusions For the primary endpoint, the score of the late phase on the MAT questionnaire was not statistically different between the PAL and GRA treatment groups.","[{'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Tsubata', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Nakao', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Amano', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Takamasa', 'Initials': 'T', 'LastName': 'Hotta', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Okimoto', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Takashige', 'Initials': 'T', 'LastName': 'Kuraki', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Itakura', 'Affiliation': 'Department of Surgery, Shimane University Faculty of Medicine, Shimane, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Isobe', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, Shimane, Japan.'}]",The journal of medical investigation : JMI,['10.2152/jmi.66.269'] 1245,31656294,Postoperative nausea and vomiting following lower limb surgery :a comparison between single-injection intraarticular anesthesia and continuous epidural anesthesia.,"Study Objective : the incidence of postoperative nausea and vomiting (PONV) following single-injection intraarticular anesthesia was compared to that following continuous epidural anesthesia. Design : Prospective, double-blind, randomized study. Setting : University-affiliated teaching hospital. Patients : Forty-eight patients finally participated in this study, and each group contained twenty-four patients. Interventions : Patients scheduled to undergo lower limb surgery under general anesthesia were randomly allocated into two groups, to receive either single-injection intraarticular or continuous epidural anesthesia for postoperative analgesia. Measurements : The incidence and severity of PONV, complete response rates (i.e., no vomiting or rescue antiemetic use), and pain scores were recorded 2, 24, and 48 h postoperatively. Main results : No significant differences between groups were observed in the incidence and severity of PONV, rescue antiemetic use, or complete response rate at any of the time points, but only the use of rescue analgesics was significantly less in continuous epidural anesthesia group during the 2-24h postoperative period (P=0.04). Conclusion : While the use of single-injection intraarticular anesthesia following lower limb surgery did not prevent PONV more than continuous epidural anesthesia in this study, the intraarticular technique still provides greater simplicity, safety, and cost-effectiveness. J. Med. Invest. 66 : 303-307, August, 2019.",2019,"No significant differences between groups were observed in the incidence and severity of PONV, rescue antiemetic use, or complete response rate at any of the time points, but only the use of rescue analgesics was significantly less in continuous epidural anesthesia group during the 2-24h postoperative period (P=0.04).","['Setting\u2005:\u2005University-affiliated teaching hospital', '66 : 303-307, August, 2019', 'Patients scheduled to undergo lower limb surgery under general anesthesia', 'Patients\u2005:\u2005Forty-eight patients finally participated in this study, and']","['single-injection intraarticular anesthesia', 'single-injection intraarticular anesthesia and continuous epidural anesthesia', 'single-injection intraarticular or continuous epidural anesthesia for postoperative analgesia']","['postoperative nausea and vomiting (PONV', 'incidence and severity of PONV, rescue antiemetic use, or complete response rate', 'rescue analgesics', 'Postoperative nausea and vomiting', 'simplicity, safety, and cost-effectiveness', 'incidence and severity of PONV, complete response rates (i.e., no vomiting or rescue antiemetic use), and pain scores']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",48.0,0.0531187,"No significant differences between groups were observed in the incidence and severity of PONV, rescue antiemetic use, or complete response rate at any of the time points, but only the use of rescue analgesics was significantly less in continuous epidural anesthesia group during the 2-24h postoperative period (P=0.04).","[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima JAPAN.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Kakuta', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Murakami', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Shiho', 'Initials': 'S', 'LastName': 'Satomi', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Oyama', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Ohshita', 'Affiliation': 'Department of Anesthesiology, Osaka Dental University, Osaka JAPAN.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Takasago', 'Affiliation': 'Department of Orthopedics, Institute of Biomedical Sciences, University of Tokushima Graduate School, Tokushima, JAPAN.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hamada', 'Affiliation': 'Department of Orthopedics, Institute of Biomedical Sciences, University of Tokushima Graduate School, Tokushima, JAPAN.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Sairyo', 'Affiliation': 'Department of Orthopedics, Institute of Biomedical Sciences, University of Tokushima Graduate School, Tokushima, JAPAN.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology, Tokushima University, Tokushima JAPAN.'}]",The journal of medical investigation : JMI,['10.2152/jmi.66.303'] 1246,31558376,"Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial.","BACKGROUND Strongyloides stercoralis infection is a neglected condition that places people who are immunocompromised at risk of hyperinfection and death. Ivermectin is the drug of choice for the treatment of S stercoralis infection, but there is no definitive evidence on the optimal dose. This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis. METHODS Our study was designed as a multicentre, open-label, phase 3, randomised controlled superiority trial. Participants were enrolled in four centres in Italy, three in Spain, and two in the UK, and recruiting sites were predominantly hospitals. Eligible patients were older than 5 years, weighed more than 15 kg, were residents in an area not endemic for S stercoralis, and either were positive for S stercoralis in faecal tests and on serology (any titre) or had a positive serological test with high titres, irrespective of the result of faecal tests. Patients were randomly assigned (1:1) using a computer-generated, blinded allocation sequence (with randomly mixed block sizes of six, eight, and ten participants) to receive either one dose of ivermectin 200 μg/kg or four doses of ivermectin 200 μg/kg (given on days 1, 2, 15, and 16). The primary endpoint was the proportion of participants with clearance of S stercoralis infection at 12 months, which was assessed in all randomly assigned participants who were not lost to follow-up (modified full-analysis set) and in participants in the modified full-analysis set who did not deviate from the assigned treatment regimen (per-protocol set). All participants were included in the safety analysis. The trial was registered with ClinicalTrials.gov, NCT01570504, and is now closed for recruitment. FINDINGS Of the 351 patients assessed for eligibility, 309 recruited between March 26, 2013, and May 3, 2017, were randomly assigned to one dose (n=155) or four doses (n=154) of ivermectin. At 12 months in the modified full-analysis set, 86% (95% CI 79 to 91; 102 of 118 participants) had responded to treatment in the single-dose group compared with 85% (77 to 90; 96 of 113 participants) in the four-dose group (risk difference 1·48%, 95% CI -7·55 to 10·52; p=0·75); similar results were observed in the per-protocol set. Adverse events were generally of mild intensity and more frequent in the multiple-dose than in the single-dose group. The trial was terminated early due to futility. INTERPRETATION Multiple doses of ivermectin did not show higher efficacy and was tolerated less than a single dose. A single dose should therefore be preferred for the treatment of non-disseminated strongyloidiasis. FUNDING There was no funding source for this study.",2019,"This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis. ","['places people who are immunocompromised at risk of hyperinfection and death', '351 patients assessed for eligibility, 309 recruited between March 26, 2013, and May 3, 2017', 'Participants were enrolled in four centres in Italy, three in Spain, and two in the UK, and recruiting sites were predominantly hospitals', 'Eligible patients were older than 5 years, weighed more than 15 kg, were residents in an area not endemic for S stercoralis, and either were positive for S stercoralis in faecal tests and on serology (any titre) or had a positive serological test with high titres, irrespective of the result of faecal tests']","['Ivermectin', 'ivermectin 200 μg/kg or four doses of ivermectin', 'ivermectin']","['proportion of participants with clearance of S stercoralis infection', 'Adverse events']","[{'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036745', 'cui_str': 'Serology'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036743', 'cui_str': 'Serological Tests'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",309.0,0.334334,"This trial aimed to assess whether multiple doses of ivermectin were superior to a single dose for the treatment of non-disseminated strongyloidiasis. ","[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Buonfrate', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy. Electronic address: dora.buonfrate@sacrocuore.it.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Salas-Coronas', 'Affiliation': 'Unidad de Medicina Tropical, Hospital de Poniente, El Ejido, Almería, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': 'Barcelona Institute for Global Health, ISGlobal-CRESIB, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Begoña Trevino', 'Initials': 'BT', 'LastName': 'Maruri', 'Affiliation': ""Unitat de Medicina Tropical Vall d'Hebron-Drassanes, Programa de Salut Internacional de l'ICS (PROSICS), Barcelona, Spain.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rodari', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Castelli', 'Affiliation': 'Department of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili General Hospital, Brescia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Zammarchi', 'Affiliation': 'Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Florence, Italy; SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': ""Department of Health Sciences, University of Florence, Anna Meyer Children's University Hospital, Florence, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Gobbi', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Cabezas-Fernández', 'Affiliation': 'Unidad de Medicina Tropical, Hospital de Poniente, El Ejido, Almería, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Requena-Mendez', 'Affiliation': 'Barcelona Institute for Global Health, ISGlobal-CRESIB, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Godbole', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust London, UK.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.'}, {'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Romero', 'Affiliation': 'Department of Medical and Oral Sciences and Biotechnologies, Università degli Studi ""G d\'Annunzio"", Chieti, Italy.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Chiodini', 'Affiliation': 'Hospital for Tropical Diseases, University College London Hospitals NHS Foundation Trust London, UK; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Bisoffi', 'Affiliation': 'Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30289-0'] 1247,31141300,Comparing the effects of 6 months aerobic exercise and resistance training on metabolic control and β-cell function in Chinese patients with prediabetes: A multicenter randomized controlled trial.,"BACKGROUND It is clear that aerobic training (AT) can delay pancreatic exhaustion and slow the progression from prediabetes to type 2 diabetes (T2D), but there is little information regarding the effects of resistance training (RT) in people with prediabetes. This study compared the effectiveness of RT and AT in improving metabolic control and protecting β-cell function in people with prediabetes. METHODS Chinese subjects (n = 248) with prediabetes were randomized to three groups: AT (n = 83), RT (n = 82) and control (n = 83). Subjects in the RT group performed 13 different resistance exercises per session using an elastic string. Those in the AT group performed aerobic exercises at 60%-70% of maximum heart rate. In both cases, exercises were performed three times per week for a period of 6 months. The primary outcome was improvement in metabolic control. Longitudinal changes between groups were tested using repeated-measures analysis of variance. RESULTS Of the initial 248 participants, 217 finished the study, but all participants were included in the intention-to-treat analyses. There were no significant differences in demographic characteristics among the RT, AT, and control groups (P > 0.05). Changes in HbA1c were not significantly greater in RT than AT cohort (P = 0.059), but the decrease in HbA1c in both exercise groups was higher than in the control group (P < 0.05). CONCLUSIONS In subjects with prediabetes, RT appears to improve metabolic control and preserve β-cell function comparable to AT.",2020,"There were no significant differences in demographic characteristics among the RT, AT, and control groups (P > 0.05).","['Of the initial 248 participants, 217 finished the study, but all participants were included in the intention-to-treat analyses', 'Chinese patients with prediabetes', 'people with prediabetes', 'Chinese subjects (n = 248) with prediabetes']","['resistance exercises per session using an elastic string', 'aerobic exercise and resistance training', 'aerobic training (AT', 'RT and AT', 'resistance training (RT']","['metabolic control and β-cell function', 'demographic characteristics', 'HbA1c', 'metabolic control', 'aerobic exercises', 'metabolic control and preserve β-cell function', 'Changes in HbA1c']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3540771', 'cui_str': 'String'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",248.0,0.0431255,"There were no significant differences in demographic characteristics among the RT, AT, and control groups (P > 0.05).","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'The First Affiliated Hospital of Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Cunyi', 'Initials': 'C', 'LastName': 'Hsue', 'Affiliation': 'Department of Nature Science, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Stony Brook University Hospital, New York.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'The First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jitao', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Danyang People's Hospital of Jiangsu Province, Danyang, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Lanzhou Ruijing Diabetes Hospital, Lanzhou, China.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mordes', 'Affiliation': 'University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Lou', 'Affiliation': 'Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.'}]",Journal of diabetes,['10.1111/1753-0407.12955'] 1248,30501447,The influence of short-term sedentary behavior on circadian rhythm of heart rate and heart rate variability.,"The notion that sedentary behavior is harmful to human health is widespread. Little is known about the short term influence of sedentary behavior on heart rate (HR) and heart rate variability (HRV) circadian rhythms. Therefore the purpose of the present study was to examine the influence of short term sedentary behavior on the circadian rhythms of HR and HRV using cosine periodic regression analysis. Sixteen healthy young students were included in a randomized crossover study. All subjects underwent 24-h ECG Holter monitoring in two different states of physical activity, an active condition (more than 15,000 steps per day) and a sedentary condition (less than 1,000 steps per day). Hourly mean values were calculated for HR and HRV, and then were evaluated using cosine periodic regression analysis. The circadian rhythm parameters, amplitude, mesor, and acrophase for HR and HRV variables were obtained. As a result, the significance of the circadian rhythm was confirmed for all variables in each condition. The measure of fit R2 value was decreased in sedentary condition. The amplitude of the sedentary condition was significantly smaller than that of the active condition with respect to HR (7.94 ± 1.91 bpm vs. 15.4 ± 3.93 bpm, p < 0.001), natural log of the high frequency measurement (lnHF) (0.38 ± 0.21 ms2 vs. 0.80 ± 0.28 ms2, p < 0.001), and low frequency/high frequency ratio (LF/HF) (0.75 ± 0.54 vs. 1.24 ± 0.69, p = 0.008). We found that sedentary behavior not only significantly lowered the amplitude of HR and HRV variables, but also might have led to weakness of the circadian rhythm of the HR and HRV variables.",2019,"The amplitude of the sedentary condition was significantly smaller than that of the active condition with respect to HR (7.94 ± 1.91 bpm vs. 15.4 ± 3.93 bpm, p < 0.001), natural log of the high frequency measurement (lnHF) (0.38 ± 0.21 ms2 vs. 0.80 ± 0.28 ms2, p < 0.001), and low frequency/high frequency ratio (LF/HF) (0.75 ± 0.54 vs. 1.24 ± 0.69, p = 0.008).",['Sixteen healthy young students'],[],"['circadian rhythm parameters, amplitude, mesor, and acrophase for HR and HRV variables', 'amplitude of HR and HRV variables', 'heart rate (HR) and heart rate variability (HRV) circadian rhythms', 'circadian rhythm of heart rate and heart rate variability', 'amplitude of the sedentary condition', 'fit R2 value']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],"[{'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",16.0,0.0273262,"The amplitude of the sedentary condition was significantly smaller than that of the active condition with respect to HR (7.94 ± 1.91 bpm vs. 15.4 ± 3.93 bpm, p < 0.001), natural log of the high frequency measurement (lnHF) (0.38 ± 0.21 ms2 vs. 0.80 ± 0.28 ms2, p < 0.001), and low frequency/high frequency ratio (LF/HF) (0.75 ± 0.54 vs. 1.24 ± 0.69, p = 0.008).","[{'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Miyagi', 'Affiliation': 'a Graduate School of health Sciences , Kobe University , Kobe , Japan.'}, {'ForeName': 'Yuh', 'Initials': 'Y', 'LastName': 'Sasawaki', 'Affiliation': 'b Gaduate School of Health Sciences, Nursing , Kobe University , Kobe , Japan.'}, {'ForeName': 'Hideuki', 'Initials': 'H', 'LastName': 'Shiotani', 'Affiliation': 'c Graduate School of Health Sciences, Preventive medicine , Kobe University , Kobe , Japan.'}]",Chronobiology international,['10.1080/07420528.2018.1550422'] 1249,30148660,Attention-Deficit/Hyperactivity Disorder-Related Deficits and Psychostimulant Medication Effects on Comprehension of Audiovisually Presented Educational Material in Children.,"Objective: We aimed to (1) examine differences in observed visual attention and motor activity, as well as comprehension of a science video between children with and without attention-deficit/hyperactivity disorder (ADHD) and (2) explore if psychostimulant medication improves ADHD behaviors and comprehension of a science video in children with ADHD. Method: Children aged 7-11 with ( n  = 91) and without ( n  = 45) ADHD watched a science video and then completed a comprehension test. Then, children with ADHD began a 4-week within-subject, randomized, double-blind crossover trial of methylphenidate (MPH). At post-testing, children were randomized to receive placebo or their optimal dosage, watched another science film, and completed a comprehension test. Results: Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video. Mediation models revealed that increased motor activity suppressed between-group differences in comprehension. MPH improved comprehension and visual attention, but not motor activity during the science video. Conclusion: Children with ADHD may benefit from MPH to improve comprehension of and sustained attention during audiovisually presented learning material.",2018,"RESULTS Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video.","['children with ADHD began a 4-week within-subject', 'children with and without attention-deficit/hyperactivity disorder (ADHD) and (2', 'Children aged 7-11 with (n\u2009=\u200991) and without (n\u2009=\u200945) ADHD watched a', 'Children with ADHD', 'Children', 'children with ADHD']","['placebo', 'methylphenidate (MPH', 'psychostimulant medication', 'science video and then completed a comprehension test']","['MPH improved comprehension and visual attention', 'motor activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",,0.218182,"RESULTS Children with ADHD exhibited higher rates of motor activity during, and worse comprehension of material discussed within, the science video.","[{'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Orban', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Tanya A', 'Initials': 'TA', 'LastName': 'Karamchandani', 'Affiliation': 'Department of Rehabilitation Psychology/Neuropsychology, TIRR Memorial Hermann Rehabilitation Network, Houston, Texas.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sidol', 'Affiliation': 'Department of Psychology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Froehlich', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Brinkman', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Estell', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Akemi E', 'Initials': 'AE', 'LastName': 'Mii', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Center for ADHD, Cincinnati, Ohio.""}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0006'] 1250,30658932,"Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial.","BACKGROUND In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib. METHODS In the phase 3, randomised, controlled, CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by risk status into favourable, intermediate, and poor risk subgroups and randomly assigned (1:1) to open-label nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg/day for 4 weeks of each 6-week cycle. Randomisation was done with a block size of four and stratified by risk status and geographical region. Patient-reported outcomes (PROs) were assessed using the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G), and EuroQol five dimensional three level (EQ-5D-3L) instruments. The coprimary endpoints of the trial, reported previously, were overall survival, progression-free survival, and the proportion of patients who had an objective response in those categorised as at intermediate or poor risk. PROs in all randomised participants were assessed as an exploratory endpoint; here we report this exploratory endpoint. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but is now closed to recruitment. FINDINGS Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) were randomly assigned to treatment, of whom 847 (77%) were at intermediate or poor risk and randomly assigned to nivolumab plus ipilimumab (n=425) or sunitinib (n=422). Median follow-up was 25·2 months (IQR 23·0-27·4). PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14 (-6·03 to -0·25) for sunitinib (p<0·0001), and for FACT-G total score being 4·77 (1·73 to 7·82) for nivolumab plus ipilimumab versus -4·32 (-8·54 to -0·11) for sunitinib (p=0·0005). Significant differences were also seen for four of five FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional wellbeing) and FACT-G physical and functional wellbeing domains. However, there was no significant difference between the treatment groups at week 103 in EQ-5D-3L visual analogue rating scale (VAS) scores, with mean change from baseline to week 103 of 10·07 (95% CI 4·35 to 15·80) for nivolumab plus ipilimumab and 6·40 (-1·36 to 14·16) for sunitinib (p=0·45). Compared with sunitinib, nivolumab plus ipilimumab reduced risk of deterioration in FKSI-19 total score (hazard ratio [HR] 0·54; 95% CI 0·46-0·63), FACT-G total score (0·63, 0·52-0·75), and EQ-5D-3L VAS score (HR 0·75, 95% CI 0·63-0·89) and UK utility scores (0·67, 0·57-0·80). INTERPRETATION Nivolumab plus ipilimumab leads to fewer symptoms and better HRQoL than sunitinib in patients at intermediate or poor risk with advanced renal cell carcinoma. These results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib comes with the additional benefit of improved HRQoL. FUNDING Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14","['patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) were randomly assigned to treatment, of whom 847 (77%) were at intermediate or poor risk and randomly assigned to', 'patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'patients at intermediate or poor risk with advanced renal cell carcinoma', 'patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214']","['sunitinib, nivolumab plus ipilimumab', 'open-label nivolumab 3 mg/kg plus ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab plus ipilimumab (n=425) or sunitinib', 'nivolumab plus ipilimumab versus -4·32']","['overall survival, progression-free survival, and the proportion of patients who had an objective response', 'EQ-5D-3L visual analogue rating scale (VAS) scores', 'UK utility scores', 'EQ-5D-3L VAS score', 'health-related quality of life (HRQoL', 'PROs', 'FACT-G total score', 'Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), Functional Assessment of Cancer Therapy-General', 'five FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional wellbeing) and FACT-G physical and functional wellbeing domains', 'risk of deterioration in FKSI-19 total score', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.267083,"PROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks after baseline, with mean change from baseline at week 103 for FKSI-19 total score being 4·00 (95% CI 1·91 to 6·09) for nivolumab plus ipilimumab versus -3·14","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: d-cella@northwestern.edu.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Hannover Medical School, Hannover, Lower Saxony, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, London, UK.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Center, Cleveland, OH, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Doan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'IQVIA, Durham, NC, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paty', 'Affiliation': 'IQVIA, Durham, NC, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30778-2'] 1251,31677985,Suction versus slow-pull for endoscopic ultrasound-guided fine-needle aspiration of pancreatic tumors: a prospective randomized trial.,"BACKGROUND Suction (S) is commonly used to improve cell acquisition during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). Slow-pull (SP) sampling is another technique that might procure good quality specimens with less bloodiness. We aimed to determine if SP improves the diagnostic yield of EUS-FNA of pancreatic masses. METHODS Patients with pancreatic solid masses were randomized to four needle passes with both techniques in an alternate fashion. Sensitivity, specificity, positive, and negative predictive values were calculated. Cellularity and bloodiness of cytological samples were assessed and compared according to the technique. RESULTS Sensitivity, specificity, and accuracy of suction vs. SP were 95.2% vs. 92.3%; 100% vs. 100; 95.7% vs. 93%, respectively. As to the association of methods, they were 95.6, 100 and 96%, respectively. Positive predictive values for S and SP were 100%. There was no difference in diagnostic yield between S and SP (p = 0.344). Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980). Bloodiness of SP and suction techniques were similar as well. CONCLUSIONS S and SP techniques provide equivalent sensitivity, specificity, and accuracy. Association of methods seems to improve diagnostic yield. Suction does not increase the bloodiness of samples compared to slow-pull.",2020,Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980).,"['Patients with pancreatic solid masses', 'pancreatic tumors']","['Suction versus slow-pull for endoscopic ultrasound-guided fine-needle aspiration', 'Slow-pull (SP) sampling']","['Bloodiness of SP and suction techniques', 'Cellularity and bloodiness of cytological samples', 'Sensitivity, specificity, positive, and negative predictive values', 'diagnostic yield', 'Sensitivity, specificity, and accuracy of suction vs. SP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",,0.0511413,Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980).,"[{'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Vitor O', 'Initials': 'VO', 'LastName': 'Brunaldi', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil. Electronic address: vitor.brunaldi@usp.br.'}, {'ForeName': 'Mauricio K', 'Initials': 'MK', 'LastName': 'Minata', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Chacon', 'Affiliation': 'Pathology Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'da Silveira', 'Affiliation': 'Insite Digestive Health, San Jose, CA, USA.'}, {'ForeName': 'Diogo Th', 'Initials': 'DT', 'LastName': 'de Moura', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcos El', 'Initials': 'ME', 'LastName': 'Dos Santos', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Sergio E', 'Initials': 'SE', 'LastName': 'Matuguma', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Dalton M', 'Initials': 'DM', 'LastName': 'Chaves', 'Affiliation': 'Gastrointestinal Endoscopy Unit, Gastroenterology Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Raony F', 'Initials': 'RF', 'LastName': 'França', 'Affiliation': 'University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Alfredo L', 'Initials': 'AL', 'LastName': 'Jacomo', 'Affiliation': 'General Surgery Department, University of São Paulo Medical School, São Paulo, SP, Brazil.'}, {'ForeName': 'Everson LA', 'Initials': 'E', 'LastName': 'Artifon', 'Affiliation': 'General Surgery Department, University of São Paulo Medical School, São Paulo, SP, Brazil.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.10.007'] 1252,31334554,A Mediterranean Diet Rich in Extra-Virgin Olive Oil Is Associated with a Reduced Prevalence of Nonalcoholic Fatty Liver Disease in Older Individuals at High Cardiovascular Risk.,"BACKGROUND Adherence to a Mediterranean diet (MedDiet) is thought to reduce liver steatosis. OBJECTIVES To explore the associations with liver steatosis of 3 different diets: a MedDiet + extra-virgin olive oil (EVOO), MedDiet + nuts, or a control diet. METHODS This was a subgroup analysis nested within a multicenter, randomized, parallel-group clinical trial, PREvención con DIeta MEDiterránea (PREDIMED trial: ISRCTN35739639), aimed at assessing the effect of a MedDiet on the primary prevention of cardiovascular disease. One hundred men and women (mean age: 64 ± 6 y), at high cardiovascular risk (62% with type 2 diabetes) from the Bellvitge-PREDIMED center were randomly assigned to a MedDiet supplemented with EVOO, a MedDiet supplemented with mixed nuts, or a control diet (advice to reduce all dietary fat). No recommendations to lose weight or increase physical activity were given. Main measurements were the percentage of liver fat and the diagnosis of steatosis, which were determined by NMR imaging. The association of diet with liver fat content was analyzed by bivariate analysis after a median follow-up of 3 y. RESULTS Baseline adiposity and cardiometabolic risk factors were similar among the 3 treatment arms. At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027). Respective mean values of liver fat content were 1.2%, 2.7%, and 4.1% (P = 0.07). A tendency toward significance was observed for the MedDiet + EVOO group compared with the control group. Median values of urinary 12(S)-hydroxyeicosatetraenoic acid/creatinine concentrations were significantly (P = 0.001) lower in the MedDiet + EVOO (2.3 ng/mg) than in the MedDiet + nuts (5.0 ng/mg) and control (3.9 ng/mg) groups. No differences in adiposity or glycemic control changes were seen between groups. CONCLUSIONS An energy-unrestricted MedDiet supplemented with EVOO, a food with potent antioxidant and anti-inflammatory properties, is associated with a reduced prevalence of hepatic steatosis in older individuals at high cardiovascular risk.",2019,"At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027).","['Older Individuals at High Cardiovascular Risk', 'older individuals at high cardiovascular risk', 'One hundred men and women (mean age: 64\xa0±\xa06 y), at high cardiovascular risk (62% with type 2 diabetes) from the Bellvitge-PREDIMED center']","['MedDiet supplemented with EVOO, a MedDiet supplemented with mixed nuts, or a control diet (advice to reduce all dietary fat', 'MedDiet\xa0+\xa0extra-virgin olive oil (EVOO), MedDiet\xa0+\xa0nuts, or a control diet', 'Mediterranean diet (MedDiet']","['adiposity or glycemic control changes', 'percentage of liver fat and the diagnosis of steatosis', 'weight or increase physical activity', 'hepatic steatosis', 'Baseline adiposity and cardiometabolic risk factors', 'Median values of urinary 12(S)-hydroxyeicosatetraenoic acid/creatinine concentrations', 'liver fat content']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0453347', 'cui_str': 'Mixed nuts (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012171', 'cui_str': 'Dietary Fats'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020349', 'cui_str': 'HETE'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",100.0,0.061293,"At 3 y after the intervention hepatic steatosis was present in 3 (8.8%), 12 (33.3%), and 10 (33.3%) of the participants in the MedDiet + EVOO, MedDiet + nuts, and control diet groups, respectively (P = 0.027).","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Fanlo-Maresma', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Emili', 'Initials': 'E', 'LastName': 'Corbella', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Corbella', 'Affiliation': 'Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Mitjavila', 'Affiliation': 'Departament de Biologia Cel.lular, Fisiologia i Immunologia, Facultat de Biologia, INSA-UB, Universidad de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Moreno', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Ciber Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxz147'] 1253,30586726,Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial.,"BACKGROUND Obesity is thought to increase renal hyperfiltration, thereby increasing albuminuria and the progression of renal disease. The effect of pharmacologically mediated weight loss on renal outcomes is not well-described. Lorcaserin, a selective serotonin 2C receptor agonist that promotes appetite suppression, led to sustained weight loss without any increased risk for major adverse cardiovascular (CV) events in the CAMELLIA-TIMI 61 trial (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61). METHODS CAMELLIA-TIMI 61 randomly assigned 12 000 overweight or obese patients with or at high risk for atherosclerotic CV disease to lorcaserin or placebo on a background of lifestyle modification. The primary renal outcome was a composite of new or worsening persistent micro- or macroalbuminuria, new or worsening chronic kidney disease, doubling of serum creatinine, end-stage renal disease, renal transplant, or renal death. RESULTS At baseline, 23.8% of patients had an estimated glomerular filtration rate (eGFR) <60 mL·min -1 ·1.73 m -2 and 19.0% had albuminuria (urinary albumin:creatinine ratio ≥30 mg/g). Lorcaserin reduced the risk of the primary renal composite outcome (4.2% per year versus 4.9% per year; hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.79-0.96; P=0.0064). The benefit was consistent across subpopulations at increased baseline CV and renal risk. Lorcaserin improved both eGFR and urinary albumin:creatinune ratio within the first year after randomization. The effect of lorcaserin on weight, hemoglobin A1c, and systolic blood pressure was consistent regardless of baseline renal function. Likewise, there was no excess in cardiovascular events in patients assigned to lorcaserin in comparison with placebo, regardless of renal function. After adjustment for baseline characteristics, those with evidence of kidney disease were at increased risk of major CV events. Compared with patients with an eGFR ≥90 mL·min -1 ·1.73 m -2 , those with an eGFR 60-90 and those <60 mL·min -1 ·1.73 m-2 had HRs of 1.25 (95% CI, 1.01, 1.56) and 1.51 (95% CI, 1.17, 1.95), respectively ( P for trend 0.0015). Likewise, compared with patients with no albuminuria (<30 mg/g), those microalbuminuria and those with macroalbuminuria had HRs of 1.46 (95% CI, 1.22, 1.74) and 2.10 (95% CI, 1.58, 2.80), respectively ( P for trend <0.0001). CONCLUSIONS Renal dysfunction was associated with increased CV risk in overweight and obese patients. When added to diet and lifestyle, lorcaserin reduced the rate of new-onset or progressive renal impairment in comparison with placebo. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT02019264.",2019,"The effect of lorcaserin on weight, hemoglobin A1c, and systolic blood pressure was consistent regardless of baseline renal function.","['Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61', 'overweight and obese patients', 'CAMELLIA-TIMI 61 randomly assigned 12\u2009000 overweight or obese patients with or at high risk for atherosclerotic CV disease to', 'on a background of lifestyle modification', 'Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial']","['lorcaserin or placebo', 'Lorcaserin', 'placebo', 'lorcaserin']","['baseline CV and renal risk', 'eGFR and urinary albumin:creatinune ratio', 'weight, hemoglobin A1c, and systolic blood pressure', 'CV risk', 'risk of the primary renal composite outcome', 'glomerular filtration rate (eGFR', 'Lorcaserin and Renal Outcomes', 'composite of new or worsening persistent micro- or macroalbuminuria, new or worsening chronic kidney disease, doubling of serum creatinine, end-stage renal disease, renal transplant, or renal death', 'risk of major CV events', 'cardiovascular events', 'renal function', 'rate of new-onset or progressive renal impairment']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0543468', 'cui_str': 'Thea'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",12000.0,0.562195,"The effect of lorcaserin on weight, hemoglobin A1c, and systolic blood pressure was consistent regardless of baseline renal function.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, TN (J.P.D.).'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia (A.C.K.).'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Smith', 'Affiliation': 'Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando (S.R.S.).'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Kyungah', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Canada (L.A.L.).""}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada (M.G.).'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ (T.P., W.M., C.P.).'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Miao', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ (T.P., W.M., C.P.).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ (T.P., W.M., C.P.).'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (B.M.S., E.A.B., A.Q., S.A.M., K.I., M.P.B., C.T.R., M.S.S., S.D.W.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.118.038341'] 1254,30621460,A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury.,"PURPOSE Medically underserved adults with spinal cord injury (SCI) remain at high risk of incurring medically serious pressure injuries even after receiving education in prevention techniques. The purpose of this research is to identify circumstances leading to medically serious pressure injury development in medically underserved adults with SCI during a lifestyle-based pressure injury prevention program, and provide recommendations for future rehabilitation approaches and intervention design. METHODS This study entailed a qualitative secondary case analysis of treatment notes from a randomized controlled trial. Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT. RESULTS AND CONCLUSIONS Among the 25 participants, 40 unique medically serious pressure injuries were detected. The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach. Together, these factors may have undermined the effectiveness of the intervention program. Modifications, such as assessing health literacy levels of patients prior to providing care, providing tailored wound care education, and focusing on equipment needs, have potential for altering future rehabilitation programs and improving health outcomes. Implications for rehabilitation To provide patients with spinal cord injury with the necessary information to prevent medically serious pressure injury development, health care providers need to understand their patient's unique personal contexts, including socio-economic status, language skills, and mental/cognitive functioning. When providing wound care information to patients with spinal cord injury who have developed a medically serious pressure injury, practitioners should take into account the level of health literacy of their patient in order to provide education that is appropriate and understandable. Practitioners should be aware of how to help their patient advocate for outside services and care that address their equipment needs, such as finding funding or grants to pay for expensive medical equipment.",2019,The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach.,"['patients with spinal cord injury', 'medically underserved adults with spinal cord injury', 'Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT', '25 participants, 40 unique medically serious pressure injuries', 'patients with spinal cord injury who have developed a medically serious pressure injury, practitioners', 'medically underserved adults with SCI during a lifestyle-based pressure injury prevention program', 'Medically underserved adults with spinal cord injury (SCI']",[],"[""medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0014674', 'cui_str': 'Apparatus and Instruments'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",40.0,0.0512108,The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach.,"[{'ForeName': 'Lucía I', 'Initials': 'LI', 'LastName': 'Floríndez', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Mike E', 'Initials': 'ME', 'LastName': 'Carlson', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pyatak', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Cogan', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Alix G', 'Initials': 'AG', 'LastName': 'Sleight', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hill', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Blanche', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Garber', 'Affiliation': 'e Baylor College of Medicine , Houston , TX , USA.'}, {'ForeName': 'Florence A', 'Initials': 'FA', 'LastName': 'Clark', 'Affiliation': 'a USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry , University of Southern California , Los Angeles , CA , USA.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1552328'] 1255,30617786,Training endogenous pain modulation: a preliminary investigation of neural adaptation following repeated exposure to clinically-relevant pain.,"Analgesic treatments that aim to eliminate pain display marginal success in relieving chronic pain and may increase pain vulnerability. Repeated exposure to pain may result in increased pain modulation via engagement of anti-nociceptive brain regions. It was hypothesized that repeated exposure to delayed onset muscle soreness (DOMS) would result in increased pain modulatory capacity (PMC) via functional neural adaptation. 23 healthy participants completed Baseline and Follow Up resting-state fMRI and quantitative sensory testing (QST) visits 40 days apart. Participants were randomized to two groups: A Repeated DOMS Group (RD Group) that received four, weekly DOMS inductions and a Control Group that received one baseline induction. Daily pain ratings were collected for seven days post-induction, as were quantitative sensory testing (QST) metrics at baseline and Follow Up. Regional functional connectivity (FC) was estimated among areas involved in pain modulation. Seed and network FC was estimated among areas involved in pain modulation and sensory processing. Changes in FC were compared between groups. The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures. RD Group participants displayed greater adaptation in nucleus accumbens-medial prefrontal cortex (NAc-mPFC) FC and in sensorimotor network (SMN) connectivity with the dorsomedial, ventromedial, and rostromedial prefrontal cortices. Changes in SMN-PFC connectivity correlated with reductions in post-DOMS affective distress. Results suggest that repeated exposure to clinically-relevant pain results in adaptations among brain regions involved in pain modulation. Repeated exposure to clinically-relevant pain may serve as a mechanism to increase PMC via inhibition of emotional valuation of painful stimuli.",2020,The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures.,['23 healthy participants completed Baseline and Follow Up resting-state fMRI and quantitative sensory testing (QST) visits 40\xa0days apart'],"['DOMS Group (RD Group) that received four, weekly DOMS inductions and a Control Group that received one baseline induction']","['Seed and network FC', 'quantitative sensory testing (QST) metrics', 'pain modulatory capacity (PMC) via functional neural adaptation', 'Changes in FC', 'thermal QST measures', 'pain vulnerability', 'Regional functional connectivity (FC', 'post-DOMS pain ratings', 'Daily pain ratings', 'adaptation in nucleus accumbens-medial prefrontal cortex (NAc-mPFC) FC and in\xa0sensorimotor network (SMN) connectivity with the dorsomedial, ventromedial, and rostromedial prefrontal cortices']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",23.0,0.271475,The RD Group displayed significant reductions in post-DOMS pain ratings and significant changes in thermal QST measures.,"[{'ForeName': 'Landrew', 'Initials': 'L', 'LastName': 'Sevel', 'Affiliation': 'Osher Center for Integrative Medicine at Vanderbilt, Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Suite 380, 3401 West End Avenue, Nashville, TN, 37203, USA. landrew.s.sevel@vanderbilt.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'Alappattu', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bishop', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Brain imaging and behavior,['10.1007/s11682-018-0033-8'] 1256,30412448,"Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration.","Purpose: To evaluate safety and efficacy of the vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab for neovascular age-related macular degeneration. Methods: Phase 2, multicenter, randomized, double-masked comparison (REACH study, stage 3). Patients ( n  = 64) received intravitreal injections of abicipar 1 mg or 2 mg at baseline, week 4, and week 8 (3 injections) or ranibizumab 0.5 mg at baseline and monthly (5 injections). Results: In the abicipar 1 mg ( n  = 25), abicipar 2 mg ( n  = 23), and ranibizumab ( n  = 16) arms, respectively, least-squares mean best-corrected visual acuity (BCVA) change from baseline was +6.2, +8.3, and +5.6 letters at week 16 (primary endpoint) and +8.2, +10.0, and +5.3 letters at week 20. Least-squares mean central retinal thickness (CRT) reduction from baseline was 134, 113, and 131 μm at week 16 and 116, 103, and 138 μm at week 20. Intraocular inflammation adverse events (AEs), reported in 5/48 (10.4%) abicipar-treated patients, resolved without sustained vision loss or other sequelae. Conclusions: Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection). No serious AEs were reported.",2018,"CONCLUSIONS Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection).","['Neovascular Age-Related Macular Degeneration', 'neovascular age-related macular degeneration']","['intravitreal injections of abicipar 1\u2009mg or 2\u2009mg at baseline', 'Abicipar Pegol (an Anti-VEGF DARPin Therapeutic', 'vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab', 'ranibizumab 0.5\u2009mg at baseline and monthly (5 injections', 'ranibizumab']","['sustained vision loss or other sequelae', 'Intraocular inflammation adverse events (AEs', 'Least-squares mean central retinal thickness (CRT) reduction', 'durability of effect: BCVA and CRT improvements']","[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242210', 'cui_str': 'Binding Proteins'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.4859,"CONCLUSIONS Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Texas Retina Associates, Arlington, Texas.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina, Abilene, Texas.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Department of Biomedical and Clinical Sciences, Eye Clinic, University of Milan, ""Luigi Sacco"" Hospital, Milan, Italy.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology and Bern Photographic Reading Center, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Cheetham', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hohman', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'López', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Allergan plc, Irvine, California.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2018.0062'] 1257,30660609,"Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial.","BACKGROUND There is no recommended therapy for malignant pleural mesothelioma that has progressed after first-line pemetrexed and platinum-based chemotherapy. Disease control has been less than 30% in all previous studies of second-line drugs. Preliminary results have suggested that anti-programmed cell death 1 (PD-1) monoclonal antibody could be efficacious in these patients. We thus aimed to prospectively assess the anti-PD-1 monoclonal antibody alone or in combination with anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody in patients with malignant pleural mesothelioma. METHODS This multicentre randomised, non-comparative, open-label, phase 2 trial was done at 21 hospitals in France. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum-based treatments, measurable disease by CT, and life expectancy greater than 12 weeks. Patients were randomly allocated (1:1) to receive intravenous nivolumab (3 mg/kg bodyweight) every 2 weeks, or intravenous nivolumab (3 mg/kg every 2 weeks) plus intravenous ipilimumab (1 mg/kg every 6 weeks), given until progression or unacceptable toxicity. Central randomisation was stratified by histology (epithelioid vs non-epithelioid), treatment line (second line vs third line), and chemosensitivity to previous treatment (progression ≥3 months vs <3 months after pemetrexed treatment) and used a minimisation method with a 0·8 random factor. The primary outcome was the proportion of patients who achieved 12-week disease control, assessed by masked independent central review; the primary endpoint would be met if disease control was achieved in at least 40% of patients. The primary endpoint was assessed in the first 108 eligible patients. Efficacy analyses were also done in the intention-to-treat population and safety analyses were done in all patients who received at least one dose of their assigned treatment. This trial is registered at ClinicalTrials.gov, number NCT02716272. FINDINGS Between March 24 and August 25, 2016, 125 eligible patients were recruited and assigned to either nivolumab (n=63) or nivolumab plus ipilimumab (n=62). In the first 108 eligible patients, 12-week disease control was achieved by 24 (44%; 95% CI 31-58) of 54 patients in the nivolumab group and 27 (50%; 37-63) of 54 patients in the nivolumab plus ipilimumab group. In the intention-to-treat population, 12-week disease control was achieved by 25 (40%; 28-52) of 63 patients in the nivolumab group and 32 (52%; 39-64) of 62 patients in the combination group. Nine (14%) of 63 patients in the nivolumab group and 16 (26%) of 61 patients in the combination group had grade 3-4 toxicities. The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]). No patients had toxicities leading to death in the nivolumab group, whereas three (5%) of 62 in the combination group did (one fulminant hepatitis, one encephalitis, and one acute kidney failure). INTERPRETATION Anti-PD-1 nivolumab monotherapy or nivolumab plus anti-CTLA-4 ipilimumab combination therapy both showed promising activity in relapsed patients with malignant pleural mesothelioma, without unexpected toxicity. These regimens require confirmation in larger clinical trials. FUNDING French Cooperative Thoracic Intergroup.",2019,"The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]).","['21 hospitals in France', 'Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum-based treatments, measurable disease by CT, and life expectancy greater than 12 weeks', 'relapsed patients with malignant pleural mesothelioma', '108 eligible patients', 'patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2', 'Between March 24 and August 25, 2016, 125 eligible patients', 'patients with malignant pleural mesothelioma']","['intravenous nivolumab', 'nivolumab plus anti-CTLA-4 ipilimumab combination therapy', 'nivolumab', 'anti-PD-1 monoclonal antibody alone or in combination with anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody', 'nivolumab plus ipilimumab', 'Nivolumab or nivolumab plus ipilimumab', 'intravenous ipilimumab']","['aspartate aminotransferase or alanine aminotransferase', 'proportion of patients who achieved 12-week disease control', 'asymptomatic lipase increase', 'grade 3-4 toxicities', 'toxicities leading to death', 'asthenia', 'disease control']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0039195', 'cui_str': 'Cell-Mediated Lympholytic Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}]",125.0,0.158461,"The most frequent grade 3 adverse events were asthenia (one [2%] in the nivolumab group vs three [5%] in the combination group), asymptomatic increase in aspartate aminotransferase or alanine aminotransferase (none vs four [7%] of each), and asymptomatic lipase increase (two [3%] vs one [2%]).","[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': 'Department of Pulmonary and Thoracic Oncology, University of Lille, University Hospital (CHU) of Lille, Lille, France; French National Network of Clinical Expert Centers for Malignant Pleural Mesothelioma Management (MESOCLIN), Lille, France. Electronic address: arnaud.scherpereel@chru-lille.fr.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Department of Pneumology, University Hospital of Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lantuejoul', 'Affiliation': 'Department of BioPathology, MESOPATH, Centre de Lutte Contre le Cancer Léon Bérard, Lyon, France; University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Dô', 'Affiliation': 'Department of Pneumology, Centre de Lutte Contre le Cancer Baclesse, Caen, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bylicki', 'Affiliation': ""Department of Pneumology, Hôpital d'instruction des Armées, Percy, Clamart, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Department of Pneumology, Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Corre', 'Affiliation': 'Department of Pneumology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pneumology, Hôpital Sainte-Musse, Toulon, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Locatelli-Sanchez', 'Affiliation': 'Department of Pneumology, Centre Hospitalier Lyon-Sud Pierre-Bénite, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pneumology, Le Mans Regional Hospital, Le Mans, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guisier', 'Affiliation': 'Department of Pneumology, University Hospital of Rouen, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Urban', 'Affiliation': 'Department of Pneumology, University Hospital of CHU Angers, Angers, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ligeza-Poisson', 'Affiliation': ""Department of Medical Oncology, Clinique Mutualiste de l'Estuaire, Saint-Nazaire, France.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Thoracic Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Amour', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique IFCT, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique IFCT, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Department of Pneumology, University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'University Hospital Bichat Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris-Diderot University Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30765-4'] 1258,31680502,GlideScope® versus Macintosh laryngoscope for assessment of post-thyroidectomy vocal cord dysfunction: prospective randomized study.,"BACKGROUND Early detection of post-thyroidectomy vocal cord dysfunction is crucial. This study compared GlideScope® with Macintosh direct laryngoscope (MDL) regarding the accuracy of assessment of post-thyroidectomy vocal cord dysfunction. METHODS One hundred and twenty patients scheduled for elective thyroidectomy, aged 18 - 50 years, of either sex were enrolled in the study. Standard general anesthesia technique was used in all patients. At the end of operation, patients were randomly allocated into one of the following sequences: 1) examined with MDL then GlideScope®, or 2) examined with GlideScope® then MDL. Postoperative tele-laryngoscopic examination was done after 12 hours. The primary outcome of the study was the sensitivity and the specificity of GlideScope® to detect vocal cord dysfunction while the secondary outcomes were the Cormack-Lehane grade of the glottis visualization and the incidence of complications. RESULTS The incidence of vocal cord dysfunction was 15 (12.5%); all cases were unilateral. The GlideScope® was more sensitive (86.7%) and specific (95.2%) with higher diagnostic accuracy (94.2%) for detecting vocal cord dysfunction than MDL. There was a high agreement between the GlideScope® findings and the final diagnosis (kappa 0.754 [95% CI: 0.581-0.928]). Cormack-Lehane score was significantly better by the GlideScope® than by the MDL (P<0.001). The incidence of hoarseness of voice was 32 (26.7%) with eight cases among the diagnosed patients. No cases of aspiration or stridor were recorded. CONCLUSIONS This study demonstrates that GlideScope® is a better alternative to MDL for an accurate detection of post-thyroidectomy vocal cord dysfunction.",2020,Cormack-Lehane score was significantly better by the Glidescope® than by the MDL (p-value <0.001).,"['One hundred and twenty patients scheduled for elective thyroidectomy, aged 18 - 50 years, of either sex were enrolled in the study', 'post-thyroidectomy vocal cord dysfunction']","['GlideScope® versus Macintosh laryngoscope', 'GlideScope®', 'GlideScope® with Macintosh direct laryngoscope (MDL']","['incidence of vocal cord dysfunction', 'sensitivity and the specificity of GlideScope® to detect vocal cord dysfunction', 'Postoperative tele- laryngoscopic examination', 'aspiration or stridor', 'diagnostic accuracy', 'Cormack-Lehane score', 'incidence of hoarseness of voice', 'Cormack-Lehane grade of the glottis visualization and the incidence of complications']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0859897', 'cui_str': 'Paradoxical Vocal Fold Motion Disorder'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0859897', 'cui_str': 'Paradoxical Vocal Fold Motion Disorder'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",120.0,0.0414484,Cormack-Lehane score was significantly better by the Glidescope® than by the MDL (p-value <0.001).,"[{'ForeName': 'Marwa A', 'Initials': 'MA', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt - mar_khairy@yahoo.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maarouf', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.14043-6'] 1259,30296472,"Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03).","PURPOSE Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. METHODS AND MATERIALS This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. RESULTS Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (β = -1.53 [-2.93 to -.13], P = .03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. CONCLUSIONS This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC.",2019,"Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life.","['head and neck cancer (HNC', 'patients receiving RT for HNC', 'patients with HNC who are receiving RT', 'patients with HNC', 'Patients With Head and Neck Cancer Undergoing Radiation Therapy']","['motivational interviewing and cognitive behavioral therapy, EAT', 'psychological intervention', 'Eating', 'EAT intervention', 'radiation therapy (RT', 'Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition']","['quality of life', 'unplanned hospital admissions', 'nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment', 'nutritional behaviors', 'nutritional status']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0034380'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0304663,"Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Britton', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia; Psycho-Oncology Department, Calvary Mater Newcastle, Newcastle, Australia. Electronic address: Ben.britton@hnehealth.nsw.gov.au.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Radiation Oncology Department, Calvary Mater Newcastle, Newcastle, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bauer', 'Affiliation': 'Center for Dietetics Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Beck', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McCarter', 'Affiliation': 'School of Psychology, Faculty of Science & IT, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Harrowfield', 'Affiliation': 'Nutrition and Speech Pathology Department, Peter MacCallum Cancer Center, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Isenring', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Robina, Australia; Honorary Research Fellow, Princess Alexandra Hospital, Woolloongabba, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia; CREDITSS-Clinical Research Design, Information Technology and Statistical Support Unit, Hunter Medical Research Institute, Newcastle, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Carter', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia; Psycho-Oncology Department, Calvary Mater Newcastle, Newcastle, Australia.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2018.09.027'] 1260,30376369,Placement of Levonorgestrel Intrauterine Device at the Time of Cesarean Delivery and the Effect on Breastfeeding Duration.,"Objectives: Studies have shown that immediate postpartum initiation of long-acting reversible contraception (LARC) methods leads to increased utilization of LARC and prevention of unintended pregnancies. It is unclear if immediate postpartum levonorgestrel-releasing intrauterine device (LNG-IUD) insertion has an effect on breastfeeding success. Study Design: This study was a secondary analysis of a randomized trial that compared intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean IUD placement with women who planned for interval IUD placement at 6 or more weeks postpartum. This parallel, 1:1, nonblinded randomized trial was conducted between March 2012 and June 2014 at the University of North Carolina Women's Hospital. We recruited pregnant women aged 18-45 years who were undergoing a cesarean delivery and desired an IUD for contraception postpartum. Results: We received breastfeeding information from 63 women who desired to use a LNG-IUD. A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement. This remained true after adjusting for age, parity, and ethnicity. Conclusion: This study adds to the existing body of evidence that shows that most women are able to successfully breastfeed after immediate postpartum LNG-IUD placement. Women should be encouraged to breastfeed, and the desire to breastfeed should not preclude the initiation of a postplacental IUD. This study provides reassurance that immediate postpartum LNG-IUD placement does not adversely affect breastfeeding; however, more high-quality data are needed on the impact of hormonal IUDs on breastfeeding outcomes.",2018,"A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement.","['March 2012 and June 2014 at the University of North Carolina', '63 women who desired to use a LNG-IUD', ""Women's Hospital"", 'women who underwent intracesarean IUD placement with women who planned for interval IUD placement at 6 or more weeks postpartum', 'pregnant women aged 18-45 years who were undergoing a cesarean delivery and desired an IUD for contraception postpartum']","['intrauterine device (IUD', 'Levonorgestrel Intrauterine Device', 'levonorgestrel-releasing intrauterine device (LNG-IUD) insertion']","['Breastfeeding Duration', 'proportion of women breastfeeding']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",,0.416906,"A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement.","[{'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Levi', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Molly K', 'Initials': 'MK', 'LastName': 'Findley', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Avila', 'Affiliation': ""Division of Family Planning, Department of Obstetrics and Gynecology and Women's Health, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Bryant', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2018.0060'] 1261,31584008,Health-Related Quality of Life Before and After Use of a Smartphone App for Adolescents and Young Adults With Cancer: Pre-Post Interventional Study.,"BACKGROUND Adolescent and young adult (AYA) patients with cancer are a group with underexplored needs throughout treatment and in survivorship. This missing knowledge can influence their quality of life (QoL). Given this fact, we have developed a smartphone app based on a cocreation process and have an investigation of QoL among users planned as part of pilot testing this app. Future research is warranted to determine the effect of mobile health (mHealth) tools such as smartphone apps among the AYA cancer population. OBJECTIVE The aim of this study was to investigate the feasibility of a smartphone app among AYA patients with cancer in active treatment and posttreatment, in a pilot test by measuring health-related QoL before and after the use of the app. METHODS Participants were recruited via the youth support initiative and social organization for AYAs with cancer, Kræftværket, based at Rigshospitalet, University Hospital of Copenhagen, Denmark. Participants were evenly distributed in active treatment and posttreatment groups. After written informed consent, all participants were asked to use the app Kræftværket as they deemed appropriate over a 6-week period. The participants were asked to complete the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire before and after the 6-week period. The collected QoL data were analyzed with t tests to determine differences between groups and from baseline. RESULTS In total, we enrolled 20 participants, 10 in active treatment and 10 posttreatment (median time after treatment was 4 months) group. Median age of the participants was 25 years. No differences in QoL were seen at baseline (P=.65). The posttreatment group experienced a significant increase in overall QoL after the 6-week period (global QoL: baseline 62.5, SD 22.3; after 6 weeks 80.8, SD 9.7; P=.04). For the group in active treatment, the QoL remained stable throughout the 6 weeks. CONCLUSIONS This study shows the feasibility and possible effect on QoL associated with the use of an mHealth tool in AYA patients. mHealth support tools are warranted for this population.",2019,"The posttreatment group experienced a significant increase in overall QoL after the 6-week period (global QoL: baseline 62.5, SD 22.3; after 6 weeks 80.8, SD 9.7; P=.04).","['enrolled 20 participants, 10 in active treatment and 10 posttreatment (median time after treatment was 4 months) group', 'Participants were recruited via the youth support initiative and social organization for AYAs with cancer, Kræftværket, based at Rigshospitalet, University Hospital of Copenhagen, Denmark', 'AYA patients', 'patients with cancer in active treatment and posttreatment', 'Adolescent and young adult (AYA) patients with cancer', 'Median age of the participants was 25 years', 'Adolescents and Young Adults With Cancer']","['Smartphone App', 'smartphone']","['30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire', 'quality of life (QoL', 'overall QoL', 'QoL', 'Health-Related Quality of Life']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",20.0,0.084944,"The posttreatment group experienced a significant increase in overall QoL after the 6-week period (global QoL: baseline 62.5, SD 22.3; after 6 weeks 80.8, SD 9.7; P=.04).","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gry', 'Initials': 'G', 'LastName': 'Assam Taarnhøj', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Elsbernd', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, KS, United States.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Hjerming', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Hanghøj', 'Affiliation': 'Center of Adolescent Medicine, Department of Pediatric and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Kirsten Arntz', 'Initials': 'KA', 'LastName': 'Boisen', 'Affiliation': 'Center of Adolescent Medicine, Department of Pediatric and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",JMIR mHealth and uHealth,['10.2196/13829'] 1262,30010027,Effects of the HEART Camp Trial on Adherence to Exercise in Patients With Heart Failure.,"BACKGROUND Few exercise training studies in patients with heart failure (HF) report adherence to guideline-recommended 150 minutes of moderate-intensity exercise per week, and no studies have focused on a primary outcome of adherence. METHODS AND RESULTS This randomized controlled trial evaluated the effect of a multicomponent intervention, Heart Failure Exercise and Resistance Training (HEART) Camp, on adherence to exercise (after 6, 12, and 18 months) compared with an enhanced usual care (EUC) group. Patients (n = 204) were 55.4% male, overall average age was 60.4 years, and 47.5% were nonwhite. The HEART Camp group had significantly greater adherence at 12 (42%) and 18 (35%) months compared with the EUC group (28% and 19%, respectively). No significant difference (P > .05) was found at 6 months. The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class. Left ventricular ejection fraction (LVEF) significantly moderated the treatment effect, with greater adherence at higher LVEF. CONCLUSIONS The multicomponent HEART Camp intervention showed efficacy with significant effects at 12 months and 18 months. Adherence levels remained modest, indicating a need for additional research to address methods and strategies to promote adherence to exercise in patients with HF.",2018,"The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class.","['Patients With Heart Failure', 'Patients (n\u202f=\u202f204) were 55.4% male, overall average age was 60.4 years, and 47.5% were nonwhite', 'patients with heart failure (HF', 'patients with HF']","['enhanced usual care (EUC', 'HEART Camp Trial', 'EUC', 'multicomponent intervention, Heart Failure Exercise and Resistance Training (HEART']","['Left ventricular ejection fraction (LVEF', 'adherence', 'Adherence levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",204.0,0.0648794,"The treatment effect did not differ based on patient's age, race, gender, marital status, type of HF (preserved or reduced ejection fraction) or New York Heart Association functional class.","[{'ForeName': 'Bunny J', 'Initials': 'BJ', 'LastName': 'Pozehl', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska. Electronic address: bpozehl@unmc.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'McGuire', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, Nebraska.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Duncan', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, Nebraska.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kupzyk', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Norman', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Artinian', 'Affiliation': 'Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Deka', 'Affiliation': 'University of South Dakota, Sioux Falls, South Dakota.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Krueger', 'Affiliation': 'Bryan Heart Institute, Lincoln, Nebraska.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Saval', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Keteyian', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2018.06.007'] 1263,30648524,"Differences in Serum Biomarkers Between Combined Glucosamine and Chondroitin Versus Celecoxib in a Randomized, Double-blind Trial in Osteoarthritis Patients.","BACKGROUND Non-steroidal anti-inflammatory drugs, e.g., celecoxib, are commonly used for inflammatory conditions, but can be associated with adverse effects. Combined glucosamine hydrochloride plus chondroitin sulfate (GH+CS) are commonly used for joint pain and have no known adverse effects. Evidence from in vitro, animal and human studies suggest that GH+CS have anti-inflammatory activity, among other mechanisms of action. OBJECTIVE We evaluated the effects of GH+CS versus celecoxib on a panel of 20 serum proteins involved in inflammation and other metabolic pathways. METHODS Samples were from a randomized, parallel, double-blind trial of pharmaceutical grade 1500 mg GH + 1200 mg CS (n=96) versus 200 mg celecoxib daily (n=93) for 6- months in knee osteoarthritis (OA) patients. Linear mixed models adjusted for age, sex, body mass index, baseline serum protein values, and rescue medicine use assessed the intervention effects of each treatment arm adjusting for multiple testing. RESULTS All serum proteins except WNT16 were lower after treatment with GH+CS, while about half increased after celecoxib. Serum IL-6 was significantly reduced (by 9%, P=0.001) after GH+CS, and satisfied the FDR<0.05 threshold. CCL20, CSF3, and WNT16 increased after celecoxib (by 7%, 9% and 9%, respectively, P<0.05), but these serum proteins were no longer statistically significant after controlling for multiple testing. CONCLUSION The results of this study using samples from a previously conducted trial in OA patients, demonstrate that GH+CS reduces circulating IL-6, an inflammatory cytokine, but is otherwise comparable to celecoxib with regard to effects on other circulating protein biomarkers.",2020,"Serum IL-6 was significantly reduced (by 9%, P=0.001) after GH+CS, and satisfied the FDR<0.05 threshold.","['osteoarthritis patients', 'OA patients', 'knee osteoarthritis (OA) patients']","['glucosamine and chondroitin versus celecoxib', 'GH+CS', 'celecoxib', 'GH+CS versus celecoxib', 'glucosamine hydrochloride plus chondroitin sulfate (GH+CS', 'pharmaceutical grade 1500 mg GH + 1200 mg CS']","['serum biomarkers', 'Serum IL-6', 'CCL20, CSF3, and WNT16']","[{'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0008454', 'cui_str': 'Chondroitin'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0771903', 'cui_str': 'Glucosamine hydrochloride'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.461732,"Serum IL-6 was significantly reduced (by 9%, P=0.001) after GH+CS, and satisfied the FDR<0.05 threshold.","[{'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Herrero', 'Affiliation': 'Bioiberica S.A.U., Plaza Francesc Macia 7, 08029 Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Martinez', 'Affiliation': 'Bioiberica S.A.U., Plaza Francesc Macia 7, 08029 Barcelona, Spain.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ladd', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lo', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.'}]",Anti-inflammatory & anti-allergy agents in medicinal chemistry,['10.2174/1871523018666190115094512'] 1264,26340483,Perceptions of Barriers and Facilitators During Implementation of a Complex Model of Group Prenatal Care in Six Urban Sites.,"Group prenatal care improves perinatal outcomes, but implementing this complex model places substantial demands on settings designed for individual care. To describe perceived barriers and facilitators to implementing and sustaining CenteringPregnancy Plus (CP+) group prenatal care, 24 in-depth interviews were conducted with 22 clinicians, staff, administrators, and study personnel in six of the 14 sites of a randomized trial of the model. All sites served low-income, minority women. Sites for the present evaluation were selected for variation in location, study arm, and initial implementation response. Implementing CP+ was challenging in all sites, requiring substantial adaptations of clinical systems. All sites had barriers to meeting the model's demands, but how sites responded to these barriers affected whether implementation thrived or struggled. Thriving sites had organizational cultures that supported innovation, champions who advocated for CP+, and staff who viewed logistical demands as manageable hurdles. Struggling sites had bureaucratic organizational structures and lacked buy-in and financial resources, and staff were overwhelmed by the model's challenges. Findings suggested that implementing and sustaining health care innovation requires new practices and different ways of thinking, and health systems may not fully recognize the magnitude of change required. Consequently, evidence-based practices are modified or discontinued, and outcomes may differ from those in the original controlled studies. Before implementing new models of care, clinical settings should anticipate model demands and assess capacity for adapting to the disruptions of innovation.",2015,"All sites had barriers to meeting the model's demands, but how sites responded to these barriers affected whether implementation thrived or struggled.",['Six Urban Sites'],['implementing and sustaining CenteringPregnancy Plus (CP'],['complex model places substantial demands on settings designed for individual care'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0158484,"All sites had barriers to meeting the model's demands, but how sites responded to these barriers affected whether implementation thrived or struggled.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Novick', 'Affiliation': 'Assistant Professor, School of Nursing, Yale University West Campus, P.O. Box 27399, West Haven, CT, 06516.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Womack', 'Affiliation': 'Assistant Professor, Yale University School of Nursing, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Research Associate, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Stasko', 'Affiliation': 'Doctoral Student, Department of Psychology, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Rising', 'Affiliation': 'Founder and President Emeritus, Centering Healthcare Institute, Silver Spring, MD.'}, {'ForeName': 'Lois S', 'Initials': 'LS', 'LastName': 'Sadler', 'Affiliation': 'Professor, Yale University School of Nursing, Yale Child Study Center, West Haven, CT.'}, {'ForeName': 'Shayna C', 'Initials': 'SC', 'LastName': 'Cunningham', 'Affiliation': 'Research Scientist, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Tobin', 'Affiliation': 'President/CEO, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Yeshiva University, Clinical Directors Network, Bronx, NY.'}, {'ForeName': 'Jeannette R', 'Initials': 'JR', 'LastName': 'Ickovics', 'Affiliation': 'Professor, Yale School of Public Health, New Haven, CT.'}]",Research in nursing & health,['10.1002/nur.21681'] 1265,30639074,Recruiting Older Men to Walking Football: A Pilot Feasibility Study.,"CONTEXT Walking football (soccer) has recently emerged as a physical activity option targeted at older males to enhance health and wellbeing. DESIGN This pilot study aimed to examine the feasibility of recruiting and retaining males aged 50 years and over to an 8-week walking football programme in a professional football club. INTERVENTION Participants were recruited via social media and assigned to an intervention group or a wait-list control group. The intervention group engaged in 1 h of walking football a week led by a community coach from the professional football club, followed by an optional social session in the club facility. Physiological and psychological outcome measures were obtained onsite at the football club facility (aiding compliance and retention) at baseline and following 8-weeks, from both groups. Semi-structured interviews were conducted after the 8-week programme and 1 year later, to explore motivations for engagement and the social impact. RESULTS The opportunity to engage in football and the link to a professional football club were key attractions. All participants recruited were overweight, sedentary, exhibited blood pressures outside normal ranges, and all but two were hypertensive. Adherence to the programme was 90% over 8 weeks, and of the participants who were contacted after one year, all (n = 6) had maintained engagement in walking football. Walking football is therefore a feasible, cost-effective method of recruiting and retaining males aged 50 years and over to a physical activity programme, though attrition is to be expected.",2019,"Adherence to the programme was 90% over 8 weeks, and of the participants who were contacted after one year, all (n = 6) had maintained engagement in walking football.","['males aged 50 years and over to an 8-week walking football programme in a professional football club', 'All participants recruited were overweight, sedentary, exhibited blood pressures outside normal ranges, and all but two were hypertensive', 'Walking football (soccer']","['intervention group or a wait-list control group', 'intervention group engaged in 1\xa0h of walking football a week led by a community coach from the professional football club, followed by an optional social session']",[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]",[],,0.0453247,"Adherence to the programme was 90% over 8 weeks, and of the participants who were contacted after one year, all (n = 6) had maintained engagement in walking football.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'McEwan', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: gmcewan23@gmail.com.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Buchan', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: duncan.buchan@uws.ac.uk.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Cowan', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: daryl.cowan@uws.ac.uk.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Arthur', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: rosie.arthur@uws.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sanderson', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: mark.sanderson@uws.ac.uk.'}, {'ForeName': 'Eilidh', 'Initials': 'E', 'LastName': 'Macrae', 'Affiliation': 'University of the West of Scotland, Almada Street, Hamilton, Scotland ML3 0JB, UK. Electronic address: eilidh.macrae@uws.ac.uk.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2018.12.001'] 1266,30626222,Effects of two nights partial sleep deprivation on an evening submaximal weightlifting performance; are 1 h powernaps useful on the day of competition?,"We have investigated the effects that sleep restriction (3-h sleep during two consecutive nights) have on an evening (17:00 h) submaximal weightlifting session; and whether this performance improves following a 1-h post-lunch powernap. Fifteen resistance-trained males participated in this study. Before the experimental protocol commenced, 1RM bench press and inclined leg press and normative habitual sleep were recorded. Participants were familiarised with the testing protocol, then completed three experimental conditions with two nights of prescribed sleep: (i) Normal (N): retire at 23:00 h and wake at 06:30 h, (ii) partial sleep-deprivation (SD): retire at 03:30 h and wake at 06:30 h and (iii) partial sleep-deprivation with nap (SD N ): retire at 03:30 h and wake at 06:30 h with a 1-h nap at 13:00 h. Each condition was separated by at least 7 days and the order of administration was randomised and counterbalanced. Rectal (T rec ) and mean skin (T s ) temperatures, Profile of Mood Scores, subjective tiredness, alertness and sleepiness values were measured at 08:00, 11:00, 14:00 and 17:00 h on the day of the weightlifting session. Following the final temperature measurements at 17:00 h, participants completed a 5-min active warm-up before a 'strength' protocol. Participants performed three repetitions of right-hand grip strength, then three repetitions at each incremental load (40%, 60% and 80% of 1RM) for bench press and inclined leg press, with a 5-min recovery in between each repetition. A linear encoder was attached perpendicular to the movement, to the bar used for the exercises. Average power (AP), average force (AF), peak velocity (PV), distance (D) and time-to-peak velocity (tPV) were measured (MuscleLab software) during the concentric phase of the movements for each lift. Data were analysed using general linear models with repeated measures. The main findings were that SD reduced maximal grip (2.7%), bench press (11.2% AP, 3.3% AF and 9.4% PV) and leg press submaximal values (5.7% AP) with a trend for a reduction in AF (3.3% P = 0.06). Furthermore, RPE increased for measures of grip strength, leg and bench press during SD. Following a 1-h powernap (SD N ), values of grip and bench press improved to values similar in N, as did tiredness, alertness and sleepiness. There was a main effect for ""load"" on the bar for both bench and leg press where AP, AF, tPV values increased with load (P < 0.05) and PV decreased from the lightest to the heaviest load for both bench and leg press. An interaction of ""load and condition"" was present in leg press only, where the rate of change of AP is greater in the N than SD and SD N conditions. In addition, for PV and tPV the rate of change was greater for SD N than N or SD condition values. In summary, SD had a negative effect on grip strength and some components of bench and inclined leg press. The use of a 1-h power nap that ended 3 h before the ""strength"" assessment had a positive effect on weightlifting performance, subjective mood and ratings of tiredness.",2019,"In addition, for PV and tPV the rate of change was greater for SD N than N or SD condition values.",['Fifteen resistance-trained males participated in this study'],"['prescribed sleep: (i) Normal (N): retire at 23:00 h and wake at 06:30 h, (ii) partial sleep-deprivation (SD): retire at 03:30 h and wake at 06:30 h and (iii) partial sleep-deprivation with nap (SD N ): retire at 03:30 h and wake at 06:30 h with a 1-h nap at 13:00 h']","['1RM bench press and inclined leg press and normative habitual sleep', 'SD reduced maximal grip', 'Average power (AP), average force (AF), peak velocity (PV), distance (D) and time-to-peak velocity (tPV', 'leg press submaximal values', 'values of grip and bench press improved to values similar in N, as did tiredness, alertness and sleepiness', 'grip strength and some components of bench and inclined leg press', 'weightlifting performance, subjective mood and ratings of tiredness', 'PV', 'grip strength, leg and bench press', 'Rectal (T rec ) and mean skin (T s ) temperatures, Profile of Mood Scores, subjective tiredness, alertness and sleepiness values']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0035345', 'cui_str': 'Retirement'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0845563,"In addition, for PV and tPV the rate of change was greater for SD N than N or SD condition values.","[{'ForeName': 'Ellis J', 'Initials': 'EJ', 'LastName': 'Brotherton', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Moseley', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Langan-Evans', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Pullinger', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Robertson', 'Affiliation': 'c School for Sport and Exercise Sciences , University of Bolton , Bolton , Lancashire , UK.'}, {'ForeName': 'Jatin G', 'Initials': 'JG', 'LastName': 'Burniston', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Edwards', 'Affiliation': 'a Research Institute for Sport and Exercise Sciences , Liverpool John Moores University , Liverpool , UK.'}]",Chronobiology international,['10.1080/07420528.2018.1552702'] 1267,29673271,"Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees.","OBJECTIVE This study sought to evaluate whether a contact-based workplace education program was more effective than standard mental health literacy training in promoting early intervention and support for healthcare employees with mental health issues. METHOD A parallel-group, randomised trial was conducted with employees in 2 multi-site Ontario hospitals with the evaluators blinded to the groups. Participants were randomly assigned to 1 of 2 group-based education programs: Beyond Silence (comprising 6 in-person, 2-h sessions plus 5 online sessions co-led by employees who personally experienced mental health issues) or Mental Health First Aid (a standardised 2-day training program led by a trained facilitator). Participants completed baseline, post-group, and 3-mo follow-up surveys to explore perceived changes in mental health knowledge, stigmatized beliefs, and help-seeking/help-outreach behaviours. An intent-to-treat analysis was completed with 192 participants. Differences were assessed using multi-level mixed models accounting for site, group, and repeated measurement. RESULTS Neither program led to significant increases in help-seeking or help-outreach behaviours. Both programs increased mental health literacy, improved attitudes towards seeking treatment, and decreased stigmatized beliefs, with sustained changes in stigmatized beliefs more prominent in the Beyond Silence group. CONCLUSION Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace. The only difference was a reduction in stigmatized beliefs over time. Additional research is needed to explore the factors that lead to behaviour change.",2018,"CONCLUSION Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace.","['healthcare employees with mental health issues', 'employees in 2 multi-site Ontario hospitals with the evaluators blinded to the groups', '192 participants', 'with Healthcare Employees']","['contact-based workplace education program', '2 group-based education programs: Beyond Silence (comprising 6 in-person, 2-h sessions plus 5 online sessions co-led by employees who personally experienced mental health issues) or Mental Health First Aid (a standardised 2-day training program led by a trained facilitator', 'standard mental health literacy training', 'Workplace Mental Health Literacy Training']","['mental health knowledge, stigmatized beliefs, and help-seeking/help-outreach behaviours', 'stigmatized beliefs', 'mental health literacy, improved attitudes towards seeking treatment', 'help-seeking or help-outreach behaviours']","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.154314,"CONCLUSION Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace.","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Moll', 'Affiliation': 'School of Rehabilitation Science, McMaster University, ON, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': 'Departments of Community Health Sciences and Psychiatry, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Stuart', 'Affiliation': ""Department of Public Health Sciences, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'School of Rehabilitation Science, McMaster University, ON, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Kirsh', 'Affiliation': 'Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743718766051'] 1268,30690053,Focused attention during eating enhanced memory for meal satiety but did not reduce later snack intake in men: A randomised within-subjects laboratory experiment.,"Attending to food being eaten ('attentive eating') may reduce later overeating. However, evidence in support of this comes primarily from studies in women. The aims of the current study were to investigate the effect that attentive eating has on later food intake in men and examine potential underlying mechanisms. Using a within-subjects design, 34 men (BMI M = 23.73 kg/m 2 , SD = 2.93; age M = 29.15, SD = 11.99) consumed a fixed lunchtime meal on two study days. On one study day participants were instructed to pay attention to the sensory properties of the meal as they ate (focused attention condition), and on the other study day participants ate lunch normally. Three hours after each lunchtime session, ad libitum consumption of snack food was measured, and measures of memory for the earlier lunchtime meal were completed. Participants remembered the lunch to be significantly more satiating in the focused attention condition compared to the control condition. However, focused attention did not significantly affect later ad libitum snack intake or other measures of meal memory. Further research is needed to understand when focused attention influences subsequent food intake before this approach can be used effectively to reduce food intake.",2019,Participants remembered the lunch to be significantly more satiating in the focused attention condition compared to the control condition.,"['men', '34 men (BMI M\u202f=\u202f23.73\u202fkg/m 2 , SD\u202f=\u202f2.93; age M\u202f=\u202f29.15, SD\u202f=\u202f11.99) consumed a', ""Attending to food being eaten ('attentive eating""]",['fixed lunchtime meal'],['later snack intake'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0585039', 'cui_str': 'Lunchtime'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C3494314', 'cui_str': 'Snacking'}]",34.0,0.152773,Participants remembered the lunch to be significantly more satiating in the focused attention condition compared to the control condition.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whitelock', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK; Cancer Research UK, 407 St John Street, London, EC1V 4AD, UK. Electronic address: v.whitelock@liverpool.ac.uk.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gaglione', 'Affiliation': 'Department of Human Biology, University of Toronto, Wetmore Hall, 200 Huron Street, Toronto, Ontario, M5S 3J6, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davies-Owen', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK. Electronic address: eric.robinson@liverpool.ac.uk.'}]",Appetite,['10.1016/j.appet.2019.01.021'] 1269,30403521,"Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017.","OBJECTIVES To evaluate a multicomponent obesity prevention intervention among diverse, low-income preschoolers. METHODS Parent-child dyads (n = 534) were randomized to the Now Everybody Together for Amazing and Healthful Kids (NET-Works) intervention or usual care in Minneapolis, MN (2012-2017). The intervention consisted of home visits, parenting classes, and telephone check-ins. The primary outcomes were adjusted 24- and 36-month body mass index (BMI). RESULTS Compared with usual care, the NET-Works intervention showed no significant difference in BMI change at 24 (-0.12 kg/m 2 ; 95% confidence interval [CI] = -0.44, 0.19) or 36 months (-0.19 kg/m 2 ; 95% CI = -0.64, 0.26). Energy intake was significantly lower in the NET-Works group at 24 (-90 kcal/day; 95% CI = -164, -16) and 36 months (-101 kcal/day; 95% CI = -164, -37). Television viewing was significantly lower in the NET-Works group at 24 (rate ratio = 0.84; 95% CI = 0.75, 0.93) and 36 months (rate ratio = 0.88; 95% CI = 0.78, 0.99). Children with baseline overweight or obesity had lower BMI in the NET-Works group than those in usual care at 36 months (-0.71 kg/m 2 ; 95% CI = -1.30, -0.12). Hispanic children had lower BMI in the NET-Works group than those in usual care at 36 months (-0.59 kg/m 2 ; 95% CI = -1.14, -0.04). CONCLUSIONS In secondary analyses, NET-Works significantly reduced BMI over 3 years among Hispanic children and children with baseline overweight or obesity. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01606891.",2018,"Children with baseline overweight or obesity had lower BMI in the NET-Works group than those in usual care at 36 months (-0.71 kg/m 2 ; 95% CI = -1.30, -0.12).","['Hispanic children and children with baseline overweight or obesity', 'Parent-child dyads (n\u2009=\u2009534', 'Hispanic children', 'diverse, low-income preschoolers', 'Low-Income Preschoolers']","['home visits, parenting classes, and telephone check-ins', 'Everybody Together for Amazing and Healthful Kids (NET-Works) intervention', 'multicomponent obesity prevention intervention', 'Multicomponent Obesity Prevention Intervention']","['lower BMI', 'BMI', 'Energy intake', 'Television viewing', 'BMI change', 'adjusted 24- and 36-month body mass index (BMI']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.11907,"Children with baseline overweight or obesity had lower BMI in the NET-Works group than those in usual care at 36 months (-0.71 kg/m 2 ; 95% CI = -1.30, -0.12).","[{'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'French', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Sherwood', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Veblen-Mortenson', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'A Lauren', 'Initials': 'AL', 'LastName': 'Crain', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Meghan M', 'Initials': 'MM', 'LastName': 'JaKa', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Mitchell', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hotop', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Jerica M', 'Initials': 'JM', 'LastName': 'Berge', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Alicia S', 'Initials': 'AS', 'LastName': 'Kunin Batson', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Truesdale', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pratt', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Esposito', 'Affiliation': 'Simone A. French, Nancy E. Sherwood, Nathan R. Mitchell, and Anne Marie Hotop are with Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis. Sara Veblen-Mortenson is with Office of the Dean, School of Public Health, University of Minnesota. A. Lauren Crain is with HealthPartners Institute, Minneapolis. At the time of study, Meghan M. JaKa was with Washington, DC, Department of Health. Jerica M. Berge is with the Department of Family Medicine and Community Health, University of Minnesota. Alicia S. Kunin Batson is with the Department of Pediatrics, University of Minnesota. Kim Truesdale and June Stevens are with the University of North Carolina, Chapel Hill. Charlotte Pratt is with the National Heart, Lung, and Blood Institute, Bethesda, MD. Layla Esposito is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.'}]",American journal of public health,['10.2105/AJPH.2018.304696'] 1270,30486700,A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants.,"Objective: To optimize growth in very low birth weight (VLBW) infants, human milk fortification is standard of care in neonatal units of high-income countries. However, commercial fortifiers may not be available or it may be too expensive in resource-limited settings. As an alternative to using human milk fortifiers, we studied the effects of milk fortification with an infant formula on growth and biochemical parameters of very low birth weight (VLBW) infants Methods: We undertook a prospective, randomized controlled trial in the neonatal unit of a tertiary care hospital in South India. Preterm infants weighing <1500 grams and <34 weeks of gestation were randomized after stratification according to birth weight into two groups (<1250 g and 1250 to <1500 g). One group received fortified human milk while the other received exclusive human milk. The fortification was done with a commercially available infant milk powder added to expressed breast milk (when the infant reached 150 ml/kg/day of feeds) and continued till the infant reached 1800 g. The primary outcome was the rate of weight gain/kg/day. Secondary outcome measures were linear growth, head circumference increase, biochemical parameters to assess the adequacy or excess of protein supplementation and comorbidities like feed intolerance, sepsis, and necrotizing enterocolitis (NEC). Results: Total of 163 babies were randomized during the study period, of whom 148 babies (73 in the standard arm and 75 in the fortification arm) completed the trial. Baseline demographic data among the two groups were comparable. Weight gain/kg/day (mean difference (MD) 1.98 g/kg/day; 95% CI: 1.03-2.92; p <.001) and linear growth (MD 0.09 cm/week; 95% CI: 0.02-0.2; p =.02) was significantly higher in the fortification arm as compared to the control arm. The head growth (head circumference gain in cm/week) was higher and length of hospital stay lesser in the fortification arm, though not statistically significant. Biochemical parameters, rates of sepsis, feed intolerance, and necrotizing enterocolitis (NEC) were not different between the two groups. Conclusion: Fortification with Infant milk powder achieves better growth parameters than unfortified human milk and can be a useful alternative for feeding preterm VLBW infants in low resource settings.",2020,"Biochemical parameters, rates of sepsis, feed intolerance and necrotizing enterocolitis (NEC) were not different between the two groups. ","['Total of 163 babies were randomized during the study period, of whom 148 babies (73 in the standard arm and 75 in the fortification arm) completed the trial', 'preterm very low birth weight infants', 'neonatal unit of a tertiary care hospital in south India', 'Preterm infants weighing < 1500 grams and < 34\xa0weeks of gestation']","['fortification of human milk with an infant formula powder versus unfortified human milk', 'fortified human milk while the other received exclusive human milk']","['linear growth, head circumference increase, biochemical parameters to assess the adequacy or excess of protein supplementation and comorbidities like feed intolerance, sepsis and necrotizing enterocolitis (NEC', 'rate of weight gain/kg/day', 'length of hospital stay', 'head growth (head circumference gain', 'Biochemical parameters, rates of sepsis, feed intolerance and necrotizing enterocolitis (NEC', 'linear growth']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0018670', 'cui_str': 'Head'}]",163.0,0.241804,"Biochemical parameters, rates of sepsis, feed intolerance and necrotizing enterocolitis (NEC) were not different between the two groups. ","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital, Vellore, India.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rebekah', 'Affiliation': 'Department of Biostatistics, Christian Medical College and Hospital, Vellore, India.'}, {'ForeName': 'Yesudas', 'Initials': 'Y', 'LastName': 'Sudhakar', 'Affiliation': 'Department of Clinical Biochemistry, Christian Medical College and Hospital, Vellore, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Santhanam', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital, Vellore, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital, Vellore, India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Neonatology, Christian Medical College and Hospital, Vellore, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1554046'] 1271,30630772,"Rituximab in patients with primary CNS lymphoma (HOVON 105/ALLG NHL 24): a randomised, open-label, phase 3 intergroup study.","BACKGROUND The prognosis for primary CNS lymphoma has improved with the use of high-dose methotrexate-based chemotherapy, but patient outcomes remain poor. Rituximab, a chimeric monoclonal antibody that targets the CD20 cell surface protein, has substantial activity in systemic CD20-positive diffuse large B-cell lymphoma, but its efficacy in primary CNS lymphoma is unknown and low penetration of the large rituximab molecule through the blood-brain barrier could limit its effect. We aimed to investigate the addition of rituximab to a high-dose methotrexate-based chemotherapy regimen in patients with newly diagnosed primary CNS lymphoma. METHODS This intergroup, multicentre, open-label, randomised phase 3 study was done at 23 hospitals in the Netherlands, Australia, and New Zealand. Non-immunocompromised patients aged 18-70 years with newly diagnosed primary CNS lymphoma were randomly assigned (1:1) to receive methotrexate-based chemotherapy with or without intravenous rituximab. We used a web-based randomisation system with stratification by centre, age, and Eastern Cooperative Oncology Group-WHO performance status, and a minimisation procedure. All group assignment was open label and neither investigators nor patients were masked to allocation. All patients were treated with two 28-day cycles of induction chemotherapy, consisting of intravenous methotrexate 3 g per m 2 on days 1 and 15, intravenous carmustine 100 mg per m 2 on day 4, intravenous teniposide 100 mg per m 2 on days 2 and 3, and oral prednisone 60 mg per m 2 on days 1-5, with (R-MBVP) or without (MBVP) intravenous rituximab 375 mg per m 2 on days 0, 7, 14, and 21 in cycle one and days 0 and 14 in cycle two. Patients with response at the end of induction subsequently received high-dose cytarabine and, in patients aged 60 years or younger, low-dose whole-brain radiotherapy. The primary endpoint was event-free survival, with events defined as not reaching complete response or complete response unconfirmed at the end of treatment, or progression or death after response; analysis was adjusted for age and performance score. Patients were analysed on a modified intention-to-treat basis. This trial is registered with the Nederlands Trial Register, number NTR2427, and the Australian New Zealand Clinical Trials Registry, number ACTRN12610000908033. The trial was closed on May 27, 2016, after achieving complete accrual, and follow-up is ongoing. FINDINGS Between Aug 3, 2010, and May 27, 2016, we recruited 200 patients (109 men and 91 women; median age was 61 years [IQR 55-67]). We randomly assigned 100 patients to MBVP and 99 patients to R-MBVP. One patient was randomly assigned to the R-MBVP group but found to be ineligible because of an incorrect diagnosis and was excluded from all analyses. After a median follow-up of 32·9 months (IQR 23·9-51·5), 98 patients had had an event (51 in the MBVP group and 47 in the R-MBVP group), of whom 79 had died (41 in the MBVP group and 38 in the R-MBVP group). Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99). Grade 3 or 4 adverse events occurred in 58 (58%) patients in the MBVP group and 63 (64%) patients in the R-MBVP group, with infections (24 [24%] patients receiving MBVP vs 21 [21%] patients receiving R-MBVP), haematological toxicity (15 [15%] vs 12 [12%]), and nervous system disorders (ten [10%] vs 15 [15%]) being the most common. Life-threatening or fatal serious adverse events occurred in 12 (12%) patients in the MBVP group and ten (10%) patients in the R-MBVP group, and five (5%) patients in the MBVP group and three (3%) in the R-MBVP group died from treatment-related causes. INTERPRETATION We found no clear benefit of addition of rituximab to methotrexate, carmustine, teniposide, and prednisone chemotherapy in primary CNS lymphoma. Therefore, the results of this study do not support the use of rituximab as a component of standard treatment in primary CNS lymphoma. FUNDING Roche, the Dutch Cancer Society, and Stichting STOPhersentumoren.",2019,"Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99).","['patients with primary CNS lymphoma (HOVON 105/ALLG NHL 24', 'primary CNS lymphoma', 'Patients with response at the end of induction subsequently received', 'Between Aug 3, 2010, and May 27, 2016', 'patients with newly diagnosed primary CNS lymphoma', '200 patients (109 men and 91 women; median age was 61 years [IQR 55-67', '23 hospitals in the Netherlands, Australia, and New Zealand. Non-immunocompromised patients aged 18-70 years with newly diagnosed primary CNS lymphoma']","['Rituximab', 'carmustine 100 mg per m 2 on day 4, intravenous teniposide 100 mg per m 2 on days 2 and 3, and oral prednisone 60 mg per m 2 on days 1-5, with (R-MBVP) or without (MBVP) intravenous rituximab', 'MBVP', 'methotrexate-based chemotherapy', 'methotrexate-based chemotherapy with or without intravenous rituximab', 'low-dose whole-brain radiotherapy', 'rituximab to methotrexate, carmustine, teniposide, and prednisone chemotherapy', 'induction chemotherapy, consisting of intravenous methotrexate', 'methotrexate-based chemotherapy regimen', 'rituximab', 'high-dose cytarabine']","['Event-free survival', 'event-free survival, with events defined as not reaching complete response or complete response unconfirmed at the end of treatment, or progression or death', 'Grade 3 or 4 adverse events', 'haematological toxicity', 'Life-threatening or fatal serious adverse events', 'nervous system disorders']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4074474', 'cui_str': 'Carmustine 100 MG [BiCNU]'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]",100.0,0.173391,"Event-free survival at 1 year was 49% (95% CI 39-58) in the MBVP group (no rituximab) and 52% (42-61) in the R-MBVP group (with rituximab; hazard ratio 1·00, 95% CI 0·70-1·43, p=0·99).","[{'ForeName': 'Jacoline E C', 'Initials': 'JEC', 'LastName': 'Bromberg', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands. Electronic address: j.bromberg@erasmusmc.nl.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Issa', 'Affiliation': 'Department of Hematology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bakunina', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'Department of Hematology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Seute', 'Affiliation': 'Department of Neurology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'Department of Hematology, ETZ Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, WA, Australia; University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Schouten', 'Affiliation': 'Department of Hematology, University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Wendy B C', 'Initials': 'WBC', 'LastName': 'Stevens', 'Affiliation': 'Department of Hematology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Josee M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Hematology, Amsterdam UMC-Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Joke W', 'Initials': 'JW', 'LastName': 'Baars', 'Affiliation': 'Department of Hemato-Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Mason', 'Affiliation': 'Department of Hematology, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Hematology, Spaarne Gasthuis, Haarlem, Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neuro-Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Beijert', 'Affiliation': 'Department of Radiotherapy, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gonzales', 'Affiliation': 'Department of Anatomical Pathology, Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'Department of Pathology, Amsterdam UMC-Vrije Universiteit Amsterdam, Amsterdam, Netherlands; HOVON Pathology Facility and Biobank, Amsterdam, Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30747-2'] 1272,31672469,Impact of orally administered tramadol combined with self-selected music on adult outpatients with burns undergoing dressing change: A randomized controlled trial.,"OBJECTIVE To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes. DESIGN Randomized controlled trial. SETTING Burns and Plastic Reconstruction Unit. PARTICIPANTS Patients (N=180) with burns on up to 10%-30% of the total body surface area (TBSA). INTERVENTIONS The patients were randomly allocated to 4 equal-sized groups as follows: (1) tramadol group (TG), patients received 100mg of tramadol orally 20min before the dressing change; (2) music group (MG), patients listened to self-selected music during the dressing change; (3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and (4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2days. MAIN OUTCOME MEASURES McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes). RESULTS The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes. CONCLUSIONS In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes.",2020,"The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes. ","['Patients (N=180) with burns on up to 10%-30% of the total body surface area (TBSA', 'Burns and Plastic Reconstruction Unit', 'burn outpatients undergoing dressing changes', 'adult outpatients with burns undergoing dressing change']","['tramadol and listened to self-selected music; and (4) control group (CG', 'tramadol', 'music-plus-tramadol', 'tramadol orally 20min before the dressing change; (2) music group (MG), patients listened to self-selected music during the dressing change; (3) music-plus-tramadol group (MTG', 'tramadol combined with self-selected music', 'routine dressing change only', 'tramadol group (TG', 'music and/or tramadol']","['pain and anxiety management', 'pain and anxiety', 'McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0222045'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.152371,"The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes. ","[{'ForeName': 'Xiu-Hang', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: Suhanvip@yeah.net.'}, {'ForeName': 'Xin-Xin', 'Initials': 'XX', 'LastName': 'Gao', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: 891397174@qq.com.'}, {'ForeName': 'Wei-Wei', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: zxh012210@163.com.'}, {'ForeName': 'Jia-Ao', 'Initials': 'JA', 'LastName': 'Yu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun 130021, China. Electronic address: yujiaoao1973@126.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.10.010'] 1273,30612482,Evaluation of the effect of antenatal betamethasone on neonatal respiratory morbidities in late preterm deliveries (34-37 weeks).,"Background: Since late preterm neonates (34-36 weeks) are more at risk of respiratory morbidities, the present study was conducted to evaluate the effect of antenatal betamethasone on neonatal respiratory morbidities in women with late preterm delivery. Methods: This randomized clinical trial was performed on 240 women with single pregnancy that was at high risk of late preterm delivery (34-37 weeks). The patients were randomly assigned to either betamethasone (intramuscular injection of 12 mg of betamethasone in two doses with an interval of 24 hours) or the control group. The two groups were compared with each other in terms of respiratory morbidities, NICU admission and its cause and duration, hospitalization in the neonatal ward for more than 6 hours, and the duration of hospitalization. Results: Of all, 79 neonates (33%) had one or more respiratory morbidities. The observed morbidities in the betamethasone group were significantly less prevalent than those in the control group (19 neonates (16%) and 60 neonates (50%), respectively, p  < .001). The most frequently observed respiratory morbidity was needed for oxygen for more than an hour (34 infants, 14%). The need for oxygen for more than an hour, the need for continuous positive airway pressure (CPAP), respiratory distress syndrome (RDS), and the need for surfactant were significantly less observed in betamethasone group than in the control group. A total of 43 neonates (18%) were admitted to NICU and then hospitalized in the neonatal ward; the number of admitted neonates were significantly lower in the betamethasone group than in the control group (11 neonates (9%) and 32 neonates (27%), respectively, p  < .001). Moreover, 15 neonates (6%) were admitted to the neonatal ward and there were no significant differences between the betamethasone and control groups (10 neonates (8%) and 5 neonates (4%), respectively, p  = .182). Totally, 58 neonates (24%) were hospitalized; the number of hospitalized neonates was significantly lower in the betamethasone group than in the control group (21 neonates (18%) and 37 neonates (31%), respectively, p  = .016). Conclusion: The results of this study showed that the antenatal administration of betamethasone in late preterm delivery (34-37 weeks) can improve respiratory morbidities and decrease the frequency of NICU admission.",2020,"The two groups were compared with each other in terms of respiratory morbidities, NICU admission and its cause and duration, hospitalization in the neonatal ward for more than 6 hours, and the duration of hospitalization. ","['late preterm deliveries (34-37 weeks', '240 women with single pregnancy that was at high risk of late preterm delivery (34-37\u2009weeks', 'women with late preterm delivery']","['betamethasone', 'antenatal betamethasone', 'betamethasone (intramuscular injection of 12\u2009mg of betamethasone']","['late preterm delivery', 'number of hospitalized neonates', 'observed morbidities', 'neonatal respiratory morbidities', 'frequency of NICU admission', 'respiratory morbidities', 'continuous positive airway pressure (CPAP), respiratory distress syndrome (RDS), and the need for surfactant', 'number of admitted neonates', 'respiratory morbidities, NICU admission and its cause and duration, hospitalization in the neonatal ward for more than 6\u2009hours, and the duration of hospitalization', 'respiratory morbidity']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0341899', 'cui_str': 'Single pregnancy (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}]",240.0,0.0907449,"The two groups were compared with each other in terms of respiratory morbidities, NICU admission and its cause and duration, hospitalization in the neonatal ward for more than 6 hours, and the duration of hospitalization. ","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirzamoradi', 'Affiliation': 'Department of Perinatology, Mahdieh Hospital, Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hasani Nejhad', 'Affiliation': 'Department of Perinatology, Mahdieh Hospital, Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razyeh', 'Initials': 'R', 'LastName': 'Jamali', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidar', 'Affiliation': 'Department of Infertility, Mahdieh Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Bakhtiyari', 'Affiliation': 'Department of Community Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1554051'] 1274,19219847,The effect of daily caffeine use on cerebral blood flow: How much caffeine can we tolerate?,"Caffeine is a commonly used neurostimulant that also produces cerebral vasoconstriction by antagonizing adenosine receptors. Chronic caffeine use results in an adaptation of the vascular adenosine receptor system presumably to compensate for the vasoconstrictive effects of caffeine. We investigated the effects of caffeine on cerebral blood flow (CBF) in increasing levels of chronic caffeine use. Low (mean = 45 mg/day), moderate (mean = 405 mg/day), and high (mean = 950 mg/day) caffeine users underwent quantitative perfusion magnetic resonance imaging on four separate occasions: twice in a caffeine abstinent state (abstained state) and twice in a caffeinated state following their normal caffeine use (native state). In each state, there were two drug conditions: participants received either caffeine (250 mg) or placebo. Gray matter CBF was tested with repeated-measures analysis of variance using caffeine use as a between-subjects factor, and correlational analyses were conducted between CBF and caffeine use. Caffeine reduced CBF by an average of 27% across both caffeine states. In the abstained placebo condition, moderate and high users had similarly greater CBF than low users; but in the native placebo condition, the high users had a trend towards less CBF than the low and moderate users. Our results suggest a limited ability of the cerebrovascular adenosine system to compensate for high amounts of daily caffeine use.",2009,Caffeine reduced CBF by an average of 27% across both caffeine states.,[],"['caffeine', 'Caffeine', 'placebo']","['CBF', 'cerebral blood flow (CBF', 'cerebral blood flow']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.041164,Caffeine reduced CBF by an average of 27% across both caffeine states.,"[{'ForeName': 'Merideth A', 'Initials': 'MA', 'LastName': 'Addicott', 'Affiliation': 'Department of Radiology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA.'}, {'ForeName': 'Lucie L', 'Initials': 'LL', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Peiffer', 'Affiliation': ''}, {'ForeName': 'Luke R', 'Initials': 'LR', 'LastName': 'Burnett', 'Affiliation': ''}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Burdette', 'Affiliation': ''}, {'ForeName': 'Michael Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Hayasaka', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Kraft', 'Affiliation': ''}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Maldjian', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Laurienti', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20732'] 1275,31586587,Combination of baicalein and ethanol-wet-bonding improves dentin bonding durability.,"OBJECTIVES This study aimed to investigate the potential of baicalein combined with ethanol-wet bonding (EWB) in improving dentin bonding durability. METHODS Sixty caries-free human third molars were randomly allocated into four groups and pretreated with solutions after sectioning and polishing. The pretreatments were prepared via dissolving baicalein in ethanol at concentrations of 0, 0.01%, 0.05% and 0.1% (w/v). Microtensile bond strength (MTBS) test, failure mode analysis and interfacial nanoleakage evaluation were conducted immediately or after thermocycling or 1 month of collagenase aging. In situ zymography, contact angle, antibacterial activity and bioactivity were comprehensively assessed. RESULTS Results demonstrated that the three experimental groups exhibited higher MTBS and lower nanoleakage expression regardless of aging. MMP activity within hybrid layer and Streptococcus. mutans biofilm formation were inhibited in the experimental groups in a dose-dependent manner. Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity. Baicalein exhibited remarkable capabilities at concentrations higher than 0.05% (w/v). CONCLUSION Baicalein is a prospective candidate as bioactive dentin bonding agent. Combined with EWB, baicalein may form a functional bonding interface, thereby enhancing dentin bond strength and durability. SIGNIFICANCE Joint efforts by baicalein and EWB provides a novel therapeutic strategy for obtaining ideal adhesive-dentin interface and prolonging the longevity of restorations.",2019,Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity.,['Sixty caries-free human third molars'],"['solutions after sectioning and polishing', 'EWB, baicalein', 'baicalein and ethanol-wet-bonding', 'baicalein combined with ethanol-wet bonding (EWB']","['mutans biofilm formation', 'reactive oxygen species (ROS) expression', 'contact angle, antibacterial activity and bioactivity', 'Microtensile bond strength (MTBS) test, failure mode analysis and interfacial nanoleakage evaluation', 'dentin bond strength and durability', 'MMP activity', 'dentin bonding durability']","[{'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0052927', 'cui_str': 'baicalein'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilms'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0162772', 'cui_str': 'Active Oxygen'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]",60.0,0.0209834,Baicalein also reduced reactive oxygen species (ROS) expression in human dental pulp cells and resisted adhesive-induced cytotoxicity.,"[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Yi', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'CR&WISCO General Hospital, Wuhan, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Lanzhou Hospital of Stomatology, Lanzhou, China.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: yanghongye@whu.edu.cn.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedical Ministry of Education, School & Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: huangcui@whu.edu.cn.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103207'] 1276,30535714,The effect of platelet-rich plasma injection on post-internal urethrotomy stricture recurrence.,"PURPOSE Local injection of platelet-rich plasma (PRP) is postulated to work by delivering growth factors and cytokines that recruit healer cells and enhance recovery process at the injection site. As new scar formation leads to stricture recurrence after internal urethrotomy, we proposed to improve post-internal urethrotomy stricture recurrence rate by injecting local submucosal PRP at the time of urethrotomy. METHODS From July 2015 to June 2018, 87 male patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography) randomized into two groups of internal urethrotomy and submucosal normal saline injection (control group, 43 patients), and internal urethrotomy with submucosal autologous platelet-rich plasma injection (PRP injection group, 44 patients). According to the endpoint, which happened sooner, each patient was followed at 3-month intervals for 2 years after internal urethrotomy or until urethral stricture recurrence. RESULTS Twelve-month recurrence rates were 26.82 and 9.09% in the control and the PRP injection groups, respectively (p 0.032). After 2 years of follow-up, stricture recurrence was identified in 18 (43.90%) and 9 (21.95%) patients in the control and the PRP injection groups, respectively (p 0.34). CONCLUSION In our study, submucosal PRP injection at the site of internal urethrotomy decreased the rate of stricture recurrence a year after the intervention. This protective effect lasted for 24 months, at least. Submucosal PRP injection at the time of internal urethrotomy also decreased the length of stricture in case of recurrence.",2019,"RESULTS Twelve-month recurrence rates were 26.82 and 9.09% in the control and the PRP injection groups, respectively (p 0.032).","['group, 44 patients', 'From July 2015 to June 2018, 87 male patients with symptomatic bulbar urethral stricture (diagnosed by retrograde urethrography']","['Submucosal PRP injection', 'platelet-rich plasma injection', 'internal urethrotomy and submucosal normal saline injection (control group, 43 patients), and internal urethrotomy with submucosal autologous platelet-rich plasma injection (PRP injection', 'platelet-rich plasma (PRP']","['rate of stricture recurrence', 'stricture recurrence', 'length of stricture', 'recurrence rates']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0581495', 'cui_str': 'Urethrogram (procedure)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",87.0,0.0220129,"RESULTS Twelve-month recurrence rates were 26.82 and 9.09% in the control and the PRP injection groups, respectively (p 0.032).","[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Ghaem Hospital, Shiraz University of Medical Sciences, Firouzabad, Iran. mrezaei1986@gmail.com.'}, {'ForeName': 'Rozhin', 'Initials': 'R', 'LastName': 'Badiei', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Badiei', 'Affiliation': 'Fasa University of Medical Sciences, Fasa, Iran.'}]",World journal of urology,['10.1007/s00345-018-2597-8'] 1277,29081307,Efficacy of vortioxetine in working patients with generalized anxiety disorder.,"BACKGROUND Vortioxetine is an approved antidepressant that has also demonstrated positive effects on anxiety symptoms in subjects with generalized anxiety disorder (GAD). This post-hoc analysis evaluates the efficacy of vortioxetine in GAD subjects who are working and/or pursuing an education. METHODS In study NCT00744627, 301 GAD subjects were randomized to vortioxetine 5 mg or placebo for 8 weeks. Efficacy measures included the Hamilton Anxiety Rating Scale (HAM-A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form-36 Health Survey). In study NCT00788034, 687 GAD subjects were treated open-label with vortioxetine 5 or 10 mg for 20 weeks, after which subjects in remission were randomized to fixed-dose of vortioxetine (5 or 10 mg) or placebo for at least 24 weeks. The primary endpoint was time to relapse. Analyses were completed in subjects working and/or pursuing an education at study entry and the full analysis set. RESULTS In study NCT00744627, the effect of vortioxetine versus placebo on HAM-A total score was -4.3 (p=0.0005) in working subjects (60% of total), while the effect in the total population was -3.8 (p=0.0001). The effect was greatest in subjects in professional (-4.5, p=0.0130) and associate professional positions (-7.6, p=0.0086). Greater effects in terms of response, remission, and the SDS and SF-36 were also observed. In NCT00788034, working subjects (69% of total) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio=2.9; p<0.001), while the hazard ratio in the total population was 2.7 (p<0.0001). CONCLUSIONS The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.",2019,"The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.","['301 GAD subjects', '687 GAD subjects were', 'subjects with generalized anxiety disorder (GAD', 'GAD subjects who are working and/or pursuing an education', 'adults with GAD who are working and/or pursuing an education versus the full GAD study population', 'subjects working and/or pursuing an education at study entry and the full analysis set', 'working patients with generalized anxiety disorder']","['Vortioxetine', 'placebo', 'treated open-label with vortioxetine', 'vortioxetine 5 mg or placebo', 'vortioxetine']","['HAM-A total score', 'Hamilton Anxiety Rating Scale (HAM-A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form-36 Health Survey', 'anxiety symptoms, functioning, and quality of life', 'time to relapse', 'response, remission, and the SDS and SF-36', 'likely to relapse', 'anxiety symptoms']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3692167', 'cui_str': 'vortioxetine 5 MG'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",687.0,0.226184,"The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.","[{'ForeName': 'Michael Cronquist', 'Initials': 'MC', 'LastName': 'Christensen', 'Affiliation': '1H. Lundbeck A/S,Valby,Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Loft', 'Affiliation': '1H. Lundbeck A/S,Valby,Denmark.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Florea', 'Affiliation': '1H. Lundbeck A/S,Valby,Denmark.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': '2Mood Disorders Psychopharmacology Unit,University Health Network,University of Toronto,Toronto,Ontario,Canada.'}]",CNS spectrums,['10.1017/S1092852917000761'] 1278,31578173,"Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study.","BACKGROUND In the phase 3 TITAN study, the addition of apalutamide to androgen deprivation therapy (ADT) significantly improved the primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer. We aimed to assess health-related quality of life (HRQOL) in TITAN, including pain and fatigue. METHODS In this randomised, placebo-controlled, double-blind, phase 3 study, patients with metastatic castration-sensitive prostate cancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1 were randomly assigned (1:1), using an interactive web response system, to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo. Previous localised disease treatment or previous docetaxel for metastatic castration-sensitive prostate cancer were allowed. Randomisation was stratified by Gleason score at diagnosis, region, and previous docetaxel treatment. Randomisation was done using randomly permuted blocks (block size of four). Investigators, research staff, sponsor study team, and patients were masked to the identities of test and control treatments. Patient-reported outcomes were prespecified exploratory endpoints and were the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L). BPI and BFI were completed for 7 consecutive days (days -6 to 1 inclusive of each cycle visit), then at months 4, 8, and 12 in follow-up. FACT-P and EQ-5D-5L were completed during cycles 1-7, then every other cycle until the end of treatment, and at months 4, 8, and 12 in follow-up. Analyses were based on the intention-to-treat population. Missing patient-reported outcome assessments were calculated as the expected number of assessments for a visit minus the actual number of assessments received for that visit. For time-to-event endpoints, when median values could not be calculated because less than 50% of patients had degradation, 25th percentiles were compared. This study is registered with ClinicalTrials.gov, number NCT02489318, and is ongoing. FINDINGS Between Dec 9, 2015, and July 25, 2017, 1052 eligible patients were enrolled randomly assigned to apalutamide (n=525) or placebo (n=527). Data cutoff for this analysis of patient-reported outcomes was Nov 23, 2018. Median follow-up for time to pain-related endpoints ranged from 19·4 to 22·1 months. Patients were mostly asymptomatic at baseline: on the BPI-SF pain severity scale of 0-10, median pain scores (indicating worst pain in the past 24 h) were 1·14 (IQR 0-3·17) in the apalutamide group and 1·00 (0-2·86) in the placebo group, and median worst fatigue scores on the BFI were 1·29 (IQR 0-3·29) in the apalutamide group and 1·43 (0·14-3·14) in the placebo group. Patient experience of pain and fatigue (intensity and interference) did not differ between the groups for the duration of treatment. Median time to worst pain intensity progression was 19·09 months (95% CI 11·04-not reached) in the apalutamide group versus 11·99 months (8·28-18·46) in the placebo group (HR 0·89 [95% CI 0·75-1·06]; p=0·20). Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group). 25th percentiles for time to pain interference progression were 9·17 months (5·55-11·96) in the apalutamide group and 6·24 months (4·63-7·43) in the placebo group (HR 0·90 [95% CI 0·73-1·10]; p=0·29). FACT-P total scores and EQ-5D-5L data showed preservation of HRQOL in both groups. The median time to deterioration as determined by FACT-P total score was 8·87 months (95% CI 4·70-11·10) in the apalutamide group and 9·23 months (7·39-12·91) in the placebo group (HR 1·02 [95% CI 0·85-1·22]; p=0·85). INTERPRETATION Apalutamide with ADT is a well-tolerated and effective option for men with metastatic castration-sensitive prostate cancer. The combination significantly improves survival outcomes compared with ADT alone while maintaining HRQOL despite additive androgen blockade. FUNDING Janssen Research & Development.",2019,Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group).,"['men with metastatic castration-sensitive prostate cancer', ""patients with metastatic castration-sensitive prostate cancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1"", 'Between Dec 9, 2015, and July 25, 2017, 1052 eligible patients', 'patients with metastatic castration-sensitive prostate cancer', 'metastatic castration-sensitive prostate cancer', 'patients with metastatic castration-sensitive prostate cancer (TITAN']","['docetaxel', 'apalutamide to androgen deprivation therapy (ADT', 'ADT', 'apalutamide', 'placebo', 'interactive web response system, to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo']","['BPI-SF pain severity scale of 0-10, median pain scores', 'FACT-P total score', 'overall survival and radiographic progression-free survival', 'health-related quality of life (HRQOL) in TITAN, including pain and fatigue', 'FACT-P and EQ-5D-5L', 'survival outcomes', 'BPI and BFI', 'pain interference progression', 'Median time to worst pain intensity progression', 'median time to deterioration', 'pain and fatigue (intensity and interference', 'Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L', 'median worst fatigue scores', 'Health-related quality of life', 'Median time to pain interference progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242756', 'cui_str': 'Titan'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242756', 'cui_str': 'Titan'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1052.0,0.607179,Median time to pain interference progression was not reached in either group (95% CI 28·58-not reached in the apalutamide group; not reached-not reached in the placebo group).,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Genitourinary Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: neeraj.agarwal@hci.utah.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McQuarrie', 'Affiliation': 'Patient Reported Outcome Group, Janssen Research & Development, Horsham, PA, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Urological Cancer, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Urological Cancer, Guy's, King's, and St Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK.""}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Pereira de Santana Gomes', 'Affiliation': 'Oncology, Liga Norte Riograndense Contra O Cancer, Natal, Brazil.'}, {'ForeName': 'Byung Ha', 'Initials': 'BH', 'LastName': 'Chung', 'Affiliation': 'Yonsei University College of Medicine and Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Oncology, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Juárez Soto', 'Affiliation': 'Urology, Hospital Universitario de Jerez de la Frontera, Cadiz, Spain.'}, {'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'Urology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Given', 'Affiliation': 'Urology, Urology of Virginia, Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Miladinovic', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Dearden', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Deprince', 'Affiliation': 'Oncology, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naini', 'Affiliation': 'Clinical Oncology, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lopez-Gitlitz', 'Affiliation': 'Clinical Oncology, Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30620-5'] 1279,31661077,Examining the Use of Glucose and Physical Activity Self-Monitoring Technologies in Individuals at Moderate to High Risk of Developing Type 2 Diabetes: Randomized Trial.,"BACKGROUND Self-monitoring of behavior (namely, diet and physical activity) and physiology (namely, glucose) has been shown to be effective in type 2 diabetes (T2D) and prediabetes prevention. By combining self-monitoring technologies, the acute physiological consequences of behaviors could be shown, prompting greater consideration to physical activity levels today, which impact the risk of developing diabetes years or decades later. However, until recently, commercially available technologies have not been able to show individuals the health benefits of being physically active. OBJECTIVE The objective of this study was to examine the usage, feasibility, and acceptability of behavioral and physiological self-monitoring technologies in individuals at risk of developing T2D. METHODS A total of 45 adults aged ≥40 years and at moderate to high risk of T2D were recruited to take part in a 3-arm feasibility trial. Each participant was provided with a behavioral (Fitbit Charge 2) and physiological (FreeStyle Libre flash glucose monitor) monitor for 6 weeks, masked according to group allocation. Participants were allocated to glucose feedback (4 weeks) followed by glucose and physical activity (biobehavioral) feedback (2 weeks; group 1), physical activity feedback (4 weeks) followed by biobehavioral feedback (2 weeks; group 2), or biobehavioral feedback (6 weeks; group 3). Participant usage (including time spent on the apps and number of glucose scans) was the primary outcome. Secondary outcomes were the feasibility (including recruitment and number of sensor displacements) and acceptability (including monitor wear time) of the intervention. Semistructured qualitative interviews were conducted at the 6-week follow-up appointment. RESULTS For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups. Of the FreeStyle Libre sensor scans conducted by participants, 17% (1798/10,582) recorded rising or falling trends in glucose, and 24% (13/45) of participants changed ≥1 of the physical activity goals. For feasibility, 49% (22/45) of participants completed the study using the minimum number of FreeStyle Libre sensors, and a total of 41 sensors were declared faulty or displaced. For acceptability, participants wore the Fitbit for 40.1 (SD 3.2) days, and 20% (9/45) of participants and 53% (24/45) of participants were prompted by email to charge or sync the Fitbit, respectively. Interviews unearthed participant perceptions on the study design by suggesting refinements to the eligibility criteria and highlighting important issues about the usability, wearability, and features of the technologies. CONCLUSIONS Individuals at risk of developing T2D engaged with wearable digital health technologies providing behavioral and physiological feedback. Modifications are required to both the study and to commercially available technologies to maximize the chances of sustained usage and behavior change. The study and intervention were feasible to conduct and acceptable to most participants. TRIAL REGISTRATION International Standard Randomized Controlled Trial Number (ISRCTN) 17545949; isrctn.com/ISRCTN17545949.",2019,"For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups.","['Individuals at Moderate to High Risk of Developing Type 2 Diabetes', '45 adults aged ≥40 years and at moderate to high risk of T2D', 'individuals at risk of developing T2D.\nMETHODS', 'participants, 17% (1798/10,582) recorded rising or falling trends in glucose, and 24% (13/45) of participants changed ≥1 of the physical activity goals']","['biobehavioral feedback', 'glucose feedback (4 weeks) followed by glucose and physical activity (biobehavioral) feedback', 'physical activity feedback (4 weeks) followed by biobehavioral feedback (2 weeks', 'Self-Monitoring Technologies']","['Participant usage (including time spent on the apps and number of glucose scans', 'feasibility (including recruitment and number of sensor displacements) and acceptability (including monitor wear time) of the intervention', 'Glucose and Physical Activity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0441633'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",45.0,0.0765246,"For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups.","[{'ForeName': 'Maxine E', 'Initials': 'ME', 'LastName': 'Whelan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Orme', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Kingsnorth', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Sherar', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Denton', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14195'] 1280,31573928,Comparison of On-Site Versus Remote Mobile Device Support in the Framingham Heart Study Using the Health eHeart Study for Digital Follow-up: Randomized Pilot Study Set Within an Observational Study Design.,"BACKGROUND New electronic cohort (e-Cohort) study designs provide resource-effective methods for collecting participant data. It is unclear if implementing an e-Cohort study without direct, in-person participant contact can achieve successful participation rates. OBJECTIVE The objective of this study was to compare 2 distinct enrollment methods for setting up mobile health (mHealth) devices and to assess the ongoing adherence to device use in an e-Cohort pilot study. METHODS We coenrolled participants from the Framingham Heart Study (FHS) into the FHS-Health eHeart (HeH) pilot study, a digital cohort with infrastructure for collecting mHealth data. FHS participants who had an email address and smartphone were randomized to our FHS-HeH pilot study into 1 of 2 study arms: remote versus on-site support. We oversampled older adults (age ≥65 years), with a target of enrolling 20% of our sample as older adults. In the remote arm, participants received an email containing a link to enrollment website and, upon enrollment, were sent 4 smartphone-connectable sensor devices. Participants in the on-site arm were invited to visit an in-person FHS facility and were provided in-person support for enrollment and connecting the devices. Device data were tracked for at least 5 months. RESULTS Compared with the individuals who declined, individuals who consented to our pilot study (on-site, n=101; remote, n=93) were more likely to be women, highly educated, and younger. In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%. Once connected, continued device use over the 5-month study period was similar between the study arms. CONCLUSIONS Our pilot study demonstrated that the deployment of mobile devices among middle-aged and older adults in the context of an on-site clinic visit was associated with higher initial rates of device use as compared with offering only remote support. Once connected, the device use was similar in both groups.",2019,"In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%.","['middle-aged and older adults', 'coenrolled participants from the Framingham Heart Study (FHS) into the FHS-Health eHeart (HeH) pilot study, a digital cohort with infrastructure for collecting mHealth data', 'older adults (age ≥65 years), with a target of enrolling 20% of our sample as older adults', 'FHS participants who had an email address and smartphone']",['Site Versus Remote Mobile Device Support'],"['device connection rates', 'blood pressure cuff']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4704895', 'cui_str': 'Framingham Heart Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0183683', 'cui_str': 'Support, device (physical object)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff, device (physical object)'}]",,0.293407,"In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Spartano', 'Affiliation': 'Section of Endocrinology, Diabetes, Nutrition, and Weight Management, Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Honghuang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Section of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Fangui', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Lunetta', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Trinquart', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Valentino', 'Affiliation': 'Framingham Heart Study, Framingham, MA, United States.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Manders', 'Affiliation': 'Framingham Heart Study, Framingham, MA, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Marcus', 'Affiliation': 'Division of Hospital Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Emelia J', 'Initials': 'EJ', 'LastName': 'Benjamin', 'Affiliation': 'Framingham Heart Study, Framingham, MA, United States.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Fox', 'Affiliation': 'Framingham Heart Study, Framingham, MA, United States.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'Division of Hospital Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Murabito', 'Affiliation': 'Framingham Heart Study, Framingham, MA, United States.'}]",JMIR mHealth and uHealth,['10.2196/13238'] 1281,31559844,Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial.,"OBJECTIVE The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. SETTING Hemophilia patient associations. DESIGN Randomized, controlled trial, multicenter and intention-to-treat analysis. PARTICIPANTS A total of 65 patients with hemophilic ankle arthropathy. INTERVENTION The experimental group ( n  = 33) received one fascial therapy session per week for three weeks. The control group ( n  = 32) received no treatment. OUTCOME MEASURE The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. RESULTS Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with -1.72 (±1.86) and -0.50 (±1.39) points, respectively. CONCLUSION The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.",2020,"RESULTS Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)).","['A total of 65 patients with hemophilic ankle arthropathy', 'patients with hemophilic ankle arthropathy', 'patients with hemophilia and ankle arthropathy', 'Hemophilia patient associations']","['fascial therapy', 'manual therapy', 'fascial therapy session', 'manual therapy using fascial therapy']","['Ankle joint pain under load-bearing and non-load-bearing conditions', 'joint bleeding, joint pain and joint function', 'Hemophilia Joint Health Score', 'joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition', 'frequency joint bleeding', 'frequency of joint bleeding measured using self-reporting', 'Mean improvement of joint state', 'joint deterioration']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741040', 'cui_str': 'Ankle arthropathy'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0238656', 'cui_str': 'Ankle pain (finding)'}, {'cui': 'C1318107', 'cui_str': 'Loadbearing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018924', 'cui_str': 'Hemarthrosis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",65.0,0.143713,"RESULTS Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)).","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Donoso-Úbeda', 'Affiliation': 'Optimus Osteopathy and Physiotherapy Clinic, Murcia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Meroño-Gallut', 'Affiliation': 'Tú. Bienestar 360º, Pysiotherapy and Medical Center, Murcia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'López-Pina', 'Affiliation': 'Department of Basic Psychology and Methodology, Faculty of Psychology, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuesta-Barriuso', 'Affiliation': 'Department of Physiotherapy, European University of Madrid, Madrid, Spain.'}]",Clinical rehabilitation,['10.1177/0269215519879212'] 1282,31438615,Human Lupus Plasma Pro-Atherogenic Effects on Cultured Macrophages Are Not Mitigated by Statin Therapy: A Mechanistic LAPS Substudy.,"Background and O bjectives: Atherosclerotic cardiovascular disease (CVD) remains a major cause of morbidity and mortality in persons with systemic lupus erythematosus (SLE, lupus). Atherosclerosis, which involves interplay between cholesterol metabolism and cellular inflammatory pathways, is primarily treated with statins since statins have lipid-lowering and anti-inflammatory properties. The Lupus Atherosclerosis Prevention Study (LAPS) was designed to investigate the efficacy of statins against CVD in SLE patients. LAPS demonstrated that 2 years of atorvastatin administration did not reduce atherosclerosis progression in lupus patients. In this LAPs substudy, we use cultured macrophages to explore the atherogenic properties of plasma from LAPS subjects to explain the mechanistic rationale for the inability of statins to reduce CVD in lupus. Materials and Methods : THP-1 differentiated macrophages were treated for 18 h with 10% SLE patient plasma obtained pre- and post-atorvastatin therapy or placebo. Gene expression of the following cholesterol transport genes was measured by qRT-PCR. For efflux-ATP binding cassette transporter (ABC)A1 and ABCG1, 27-hydroxylase, peroxisome proliferator-activated receptor (PPAR)γ, and liver X receptor (LXR)α; and for influx-cluster of differentiation 36 (CD36) and scavenger receptor (ScR)A1. Results: Macrophages exposed to plasma from both statin-treated and placebo-treated groups showed a significant decrease in cholesterol efflux proteins ATP binding cassette (ABC) transporters A1 and ABCG1, an increase in 27-hydroxylase, an increase in the LDL receptor and a decrease in intracellular free cholesterol. No change in influx receptors ScRA1 and CD36, nor nuclear proteins LXRα and PPARγ was observed. Conclusions: Statins do not normalize pro-atherogenic changes induced by lupus and these changes continue to worsen over time. This study provides mechanistic insight into LAPS findings by demonstrating that statins are overall ineffective in altering the balance of cholesterol transport gene expression in human macrophages. Furthermore, our study suggests that statins as a CVD treatment may not be useful in attenuating lipid overload in the SLE environment.",2019,"No change in influx receptors ScRA1 and CD36, nor nuclear proteins LXRα and PPARγ was observed. ","['SLE patients', 'lupus patients', 'persons with systemic lupus erythematosus (SLE, lupus']","['atorvastatin', 'LAPS', 'Materials and Methods ', 'atorvastatin therapy or placebo', 'placebo', 'Statin Therapy']","['cholesterol efflux proteins ATP binding cassette (ABC) transporters A1 and ABCG1', 'intracellular free cholesterol', 'atherosclerosis progression', 'influx receptors ScRA1 and CD36, nor nuclear proteins LXRα and PPARγ']","[{'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242738', 'cui_str': 'ABC Transporters'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0368909', 'cui_str': 'Non-esterified cholesterol (substance)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0949374', 'cui_str': 'Nuclear Protein'}]",,0.0502174,"No change in influx receptors ScRA1 and CD36, nor nuclear proteins LXRα and PPARγ was observed. ","[{'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Reiss', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA. Allison.Reiss@NYULangone.org.'}, {'ForeName': 'Hirra A', 'Initials': 'HA', 'LastName': 'Arain', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Lora J', 'Initials': 'LJ', 'LastName': 'Kasselman', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Renna', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhen', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Voloshyna', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'DeLeon', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Carsons', 'Affiliation': 'NYU Winthrop Biomedical Research Institute and NYU Long Island School of Medicine, Mineola, NY 11501, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Petri', 'Affiliation': 'Division of Rheumatology, The Johns Hopkins University School of Medicine Baltimore, MD 21205, USA.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina55090514'] 1283,31674920,"Use of the Chatbot ""Vivibot"" to Deliver Positive Psychology Skills and Promote Well-Being Among Young People After Cancer Treatment: Randomized Controlled Feasibility Trial.","BACKGROUND Positive psychology interventions show promise for reducing psychosocial distress associated with health adversity and have the potential to be widely disseminated to young adults through technology. OBJECTIVE This pilot randomized controlled trial examined the feasibility of delivering positive psychology skills via the Vivibot chatbot and its effects on key psychosocial well-being outcomes in young adults treated for cancer. METHODS Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the Vivibot chatbot on Facebook messenger. Participants were randomized to either immediate access to Vivibot content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control). Created using a human-centered design process with young adults treated for cancer, Vivibot content includes 4 weeks of positive psychology skills, daily emotion ratings, video, and other material produced by survivors, and periodic feedback check-ins. All participants were assessed for psychosocial well-being via online surveys at baseline and weeks 2, 4, and 8. Analyses examined chatbot engagement and open-ended feedback on likability and perceived helpfulness and compared experimental and control groups with regard to anxiety and depression symptoms and positive and negative emotion changes between baseline and 4 weeks. To verify the main effects, follow-up analyses compared changes in the main outcomes between 4 and 8 weeks in the control group once participants had access to all chatbot content. RESULTS Data from 45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed. Participants in the experimental group spent an average of 74 minutes across an average of 12 active sessions chatting with Vivibot and rated their experience as helpful (mean 2.0/3, SD 0.72) and would recommend it to a friend (mean 6.9/10; SD 2.6). Open-ended feedback noted its nonjudgmental nature as a particular benefit of the chatbot. After 4 weeks, participants in the experimental group reported an average reduction in anxiety of 2.58 standardized t-score units, while the control group reported an increase in anxiety of 0.7 units. A mixed-effects models revealed a trend-level (P=.09) interaction between group and time, with an effect size of 0.41. Those in the experimental group also experienced greater reductions in anxiety when they engaged in more sessions (z=-1.9, P=.06). There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion. CONCLUSIONS The chatbot format provides a useful and acceptable way of delivering positive psychology skills to young adults who have undergone cancer treatment and supports anxiety reduction. Further analysis with a larger sample size is required to confirm this pattern.",2019,"There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion. ","['45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed', 'Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the Vivibot chatbot on Facebook messenger', 'Young People', 'young adults treated for cancer', 'young adults who have undergone cancer treatment and supports anxiety reduction']","['positive psychology skills', 'Chatbot ""Vivibot', 'immediate access to Vivibot content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control']","['average reduction in anxiety', 'chatbot engagement and open-ended feedback on likability and perceived helpfulness', 'depression, positive emotion, or negative emotion', 'anxiety', 'anxiety and depression symptoms and positive and negative emotion changes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",36.0,0.100779,"There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion. ","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Greer', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ramo', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Yin-Juei', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Haritatos', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15018'] 1284,31595955,Growth During Infancy and Early Childhood and Its Association With Metabolic Risk Biomarkers at 11.5 Years of Age.,"The evidence that fetal life and early infancy are ""critical"" or ""sensitive"" ages for later development of cardiometabolic disease is based on flawed methods for comparing different age periods. Moreover, most previous studies have limited their focus to weight gain, rather than growth in length/height or body mass index (weight (kg)/height (m)2). We undertook a secondary analysis of data from the Promotion of Breastfeeding Intervention Trial (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, that had repeated measurements of weight and length/height taken from birth to 11.5 years of age. We used mixed-effects linear models to analyze associations of changes in standardized weight, length/height, and body mass index during 5 age periods (conception to birth, birth to age 3 months, ages 3-12 months, ages 12 months-6.5 years, and ages 6.5-11.5 years) with fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin at age 11.5 years. We observed strong associations between the metabolic markers and all 3 growth measures, with the largest magnitudes being observed during the latest age period (ages 6.5-11.5 years) and negligible associations during gestation and the first year of life. Later age periods appear more ""sensitive"" than earlier periods to the adverse metabolic association with rapid growth in childhood.",2020,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","['PROBIT (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, with repeated measures of weight and length/height from birth to 11.5 years of age', 'at age 11.5 years']",[],"['standardized weight, length/height, and BMI', 'fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2930714', 'cui_str': 'Republic of Belarus'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",,0.020093,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom.'}, {'ForeName': 'Izzuddin M', 'Initials': 'IM', 'LastName': 'Aris', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Author affiliations: Department of Pediatrics, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}]",American journal of epidemiology,['10.1093/aje/kwz234'] 1285,31562043,"Vinorelbine and continuous low-dose cyclophosphamide as maintenance chemotherapy in patients with high-risk rhabdomyosarcoma (RMS 2005): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND For more than three decades, standard treatment for rhabdomyosarcoma in Europe has included 6 months of chemotherapy. The European paediatric Soft tissue sarcoma Study Group (EpSSG) aimed to investigate whether prolonging treatment with maintenance chemotherapy would improve survival in patients with high-risk rhabdomyosarcoma. METHODS RMS 2005 was a multicentre, open-label, randomised, controlled, phase 3 trial done at 102 hospitals in 14 countries. We included patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement. Patients in remission after standard treatment (nine cycles of ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine 25 mg/m 2 on days 1, 8, and 15, and daily oral cyclophosphamide 25 mg/m 2 , on days 1-28). Randomisation was done by use of a web-based system and was stratified (block size of four) by enrolling country and risk subgroup. Neither investigators nor patients were masked to treatment allocation. The primary outcome was disease-free survival in the intention-to-treat population. Secondary outcomes were overall survival and toxicity. This trial is registered with EudraCT, number 2005-000217-35, and ClinicalTrials.gov, number NCT00339118, and follow-up is ongoing. FINDINGS Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive maintenance chemotherapy. Median follow-up was 60·3 months (IQR 32·4-89·4). In the intention-to-treat population, 5-year disease-free survival was 77·6% (95% CI 70·6-83·2) with maintenance chemotherapy versus 69·8% (62·2-76·2) without maintenance chemotherapy (hazard ratio [HR] 0·68 [95% CI 0·45-1·02]; p=0·061), and 5-year overall survival was 86·5% (95% CI 80·2-90·9) with maintenance chemotherapy versus 73·7% (65·8-80·1) without (HR 0·52 [95% CI 0·32-0·86]; p=0·0097). Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection. One (1%) patient had a grade 4 non-haematological toxicity (neurotoxicity). Two treatment-related serious adverse events occurred: one case of inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved. INTERPRETATION Adding maintenance chemotherapy seems to improve survival for patients with high-risk rhabdomyosarcoma. This approach will be the new standard of care for patients with high-risk rhabdomyosarcoma in future EpSSG trials. FUNDING Fondazione Città della Speranza, Association Léon Berard Enfant Cancéreux, Clinical Research Hospital Program (French Ministry of Health), and Cancer Research UK.",2019,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","['Between April 20, 2006, and Dec 21, 2016, 371 patients were enrolled and randomly assigned to the two groups: 186 to stop treatment and 185 to receive', '102 hospitals in 14 countries', 'patients with high-risk rhabdomyosarcoma in future EpSSG trials', 'patients with high-risk rhabdomyosarcoma', 'patients with high-risk rhabdomyosarcoma (RMS 2005', 'patients aged 6 months to 21 years with rhabdomyosarcoma who were considered to be at high risk of relapse: those with non-metastatic incompletely resected embryonal rhabdomyosarcoma occurring at unfavourable sites with unfavourable age (≥10 years) or tumour size (>5 cm), or both; those with any non-metastatic rhabdomyosarcoma with nodal involvement; and those with non-metastatic alveolar rhabdomyosarcoma but without nodal involvement']","['Vinorelbine and continuous low-dose cyclophosphamide', 'cyclophosphamide', 'ifosfamide, vincristine, dactinomycin with or without doxorubicin, and surgery or radiotherapy, or both) were randomly assigned (1:1) to stop treatment or continue maintenance chemotherapy (six cycles of intravenous vinorelbine', 'maintenance chemotherapy']","['grade 4 non-haematological toxicity (neurotoxicity', 'survival', 'thrombocytopenia', 'overall survival and toxicity', 'anaemia', '5-year disease-free survival', 'Toxicity', 'grade 3-4 leucopenia', '5-year overall survival', 'grade 3-4 neutropenia', 'inappropriate antidiuretic hormone secretion and one of a severe steppage gait with limb pain, both of which resolved', 'disease-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0206656', 'cui_str': 'Embryonal Rhabdomyosarcoma'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0427149', 'cui_str': 'Gait, Drop Foot'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb (finding)'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}]",371.0,0.370497,"Toxicity was manageable in patients who received maintenance chemotherapy: 136 (75%) of 181 patients had grade 3-4 leucopenia, 148 (82%) had grade 3-4 neutropenia, 19 (10%) had anaemia, two (1%) had thrombocytopenia, and 56 (31%) had an infection.","[{'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy. Electronic address: gianni.bisogno@unipd.it.""}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bergeron', 'Affiliation': ""Institut d'Hématologie et d'Oncologie Pédiatrique, Centre Léon Bérard, Lyon, France.""}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Gallego Melcón', 'Affiliation': ""Servicio de Oncología y Hematología Pediatrica, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Johannes H', 'Initials': 'JH', 'LastName': 'Merks', 'Affiliation': ""Princess Máxima Center for Paediatric Oncology, Utrecht, Netherlands; Department of Paediatric Oncology, Emma Children's Hospital-Academic Medical Center Amsterdam, Netherlands.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kelsey', 'Affiliation': ""Department of Paediatric Histopathology, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Martelli', 'Affiliation': 'Department of Paediatric Surgery, Hôpital Bicêtre-Hôpitaux Universitaires Paris Sud, Assistance Publique-Hôpitaux de Paris, Le Kremlin Bicêtre, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': 'Department of Paediatric and Adolescent Oncology, Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Orbach', 'Affiliation': 'SIREDO Oncology Center, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Glosli', 'Affiliation': 'Department of Paediatric Research and Department of Paediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Chisholm', 'Affiliation': 'Children and Young Peoples Unit, Royal Marsden Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Casanova', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Zanetti', 'Affiliation': ""Haematology Oncology Division, Department of Women's and Children's Health, University of Padova, Padova, Italy.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Devalck', 'Affiliation': 'Paediatric Haematology and Oncology, Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Ben-Arush', 'Affiliation': ""Joan and Sanford Weill Pediatric Hematology Oncology and Bone Marrow Transplantation Division, Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mudry', 'Affiliation': ""University Children's Hospital Brno, Czech Republic.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Ferman', 'Affiliation': 'Instituto Nacional de Câncer, Rio de Janeiro, Brazil.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Jenney', 'Affiliation': ""Department of Paediatric Oncology, Children's Hospital for Wales, Heath Park, Cardiff, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30617-5'] 1286,30589533,Role of Serotonin Transporter and Receptor Gene Variations in the Acute Effects of MDMA in Healthy Subjects.,"Methylenedioxymethamphetamine (MDMA; ecstasy) is used recreationally and has been investigated as an adjunct to psychotherapy. Most acute effects of MDMA can be attributed to activation of the serotonin (5-hydroxytryptamine [5-HT]) system. Genetic variants, such as single-nucleotide polymorphisms (SNPs) and polymorphic regions in 5-HT system genes, may contribute to interindividual differences in the acute effects of MDMA. We characterized the effects of common genetic variants within selected genes that encode the 5-HT system ( TPH1 [tryptophan 5-hydroxylase 1] rs1800532 and rs1799913, TPH2 [tryptophan 5-hydroxylase 2] rs7305115, HTR1A [5-HT 1A receptor] rs6295, HTR1B [5-HT 1B receptor] rs6296, HTR2A [5-HT 2A receptor] rs6313, and SLC6A4 [serotonin transporter] 5-HTTLPR and rs25531) on the physiological and subjective response to 125 mg of MDMA compared with placebo in 124 healthy subjects. Data were pooled from eight randomized, double-blind, placebo-controlled studies that were conducted in the same laboratory. TPH2 rs7305115, HTR2A rs6313, and SLC6A4 5-HTTLPR polymorphisms tended to moderately alter some effects of MDMA. However, after correcting for multiple comparisons, none of the tested genetic polymorphisms significantly influenced the response to MDMA. Variations in genes that encode key targets in the 5-HT system did not significantly influence the effects of MDMA in healthy subjects. Interindividual differences in the 5-HT system may thus play a marginal role when MDMA is used recreationally or therapeutically.",2019,Variations in genes that encode key targets in the 5-HT system did not significantly influence the effects of MDMA in healthy subjects.,"['Healthy Subjects', '124 healthy subjects', 'healthy subjects']","['Methylenedioxymethamphetamine (MDMA; ecstasy', 'HTR1B [5-HT 1B receptor', 'placebo', 'MDMA', 'rs7305115, HTR1A', 'TPH2 [tryptophan 5-hydroxylase 2']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0678156', 'cui_str': 'Ecstasy (finding)'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041252', 'cui_str': 'Tryptophan Monooxygenase'}]",[],124.0,0.0595807,Variations in genes that encode key targets in the 5-HT system did not significantly influence the effects of MDMA in healthy subjects.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine, Department of Clinical Research , University Hospital Basel, University of Basel , Basel CH-4056 , Switzerland.'}, {'ForeName': 'Henriette E', 'Initials': 'HE', 'LastName': 'Meyer Zu Schwabedissen', 'Affiliation': 'Biopharmacy, Department of Pharmaceutical Sciences , University of Basel , Basel 4056 , Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine, Department of Clinical Research , University Hospital Basel, University of Basel , Basel CH-4056 , Switzerland.'}]",ACS chemical neuroscience,['10.1021/acschemneuro.8b00590'] 1287,31667735,Bioequivalence of a Newly Developed Dabigatran Etexilate Tablet Versus the Commercial Capsule and Impact of Rabeprazole-Induced Elevated Gastric pH on Exposure in Healthy Subjects.,"BACKGROUND AND OBJECTIVE Dabigatran etexilate (DE) is an anticoagulant with proven efficacy and tolerability for stroke prevention in patients with non-valvular atrial fibrillation. For the commercial capsule, a complex formulation is used to maintain the acidic microenvironment required for maximal absorption. Consequently, its efficacy and safety are similar with or without concomitant intake of proton-pump inhibitors (PPIs). A simplified DE tablet formulation was developed and tested in two studies. One investigated bioequivalence (BE) of the novel DE tablet versus the commercial DE capsule. The other investigated DE bioavailability (BA) under pretreatment with the PPI rabeprazole and assessed the effect of elevated pH on exposure to dabigatran. METHODS BE of the novel DE tablet versus the DE capsule was assessed in a randomized two-treatment, four-period, two-sequence crossover study (NCT03070171). The effect of rabeprazole on the BA of the DE tablet was assessed in an open-label, single-arm study (NCT03143166). Both studies were conducted at sites in Japan. Participants were healthy male volunteers, aged ≥ 20-40 years. In the BE study, participants received the DE tablet or capsule (single oral dose, 110 mg); primary endpoints were area under the concentration-time curve from baseline to the last quantifiable data point (AUC 0-tz ) and maximum plasma concentration (C max ) of unconjugated dabigatran. In the relative BA study, participants received the DE tablet (single oral dose, 110 mg) with or without rabeprazole pretreatment (once daily for 5 days, 20 mg); primary endpoints were AUC 0-tz and C max of total dabigatran. RESULTS In total, 160 participants were randomized in the BE study; 36 participants were enrolled in the BA study. The 90% confidence intervals of geometric mean (gMean) ratios for AUC 0-tz (101.4-116.0%) and C max (101.8-116.6%) of unconjugated dabigatran were within pre-defined acceptance criteria for BE. In the relative BA study, the gMeans of AUC 0-tz (667 to 192 ng h/mL) and C max (83.1 to 21.8 ng/mL) were decreased by approximately 70% when the tablet was administered under rabeprazole pretreatment. The reduction in BA was observed at a mean gastric pH of 5.3. Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study. CONCLUSION The DE tablet demonstrated BE to the capsule; however, at high gastric pH, BA of the tablet was reduced by approximately 70%, which may lead to reduced efficacy. Data indicate the importance of examining not only BE under standard conditions, but relative BA at elevated gastric pH. Such investigations may avoid the reduced BA at elevated pH that is quite common in the target population (the elderly and/or patients treated with gastric-acid modifying co-medications), and therefore reduce treatment failure with DE. Registration: ClinicalTrials.gov identifier numbers: NCT03070171, and NCT03143166.",2020,"Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study. ","['patients with non-valvular atrial fibrillation', 'Healthy Subjects', '160 participants were randomized in the BE study; 36 participants were enrolled in the BA study', 'Registration', 'Participants were healthy male volunteers, aged\u2009≥\u200920-40\xa0years']","['rabeprazole', 'PPI rabeprazole', 'Dabigatran etexilate (DE', 'Rabeprazole-Induced Elevated Gastric pH']","['geometric mean (gMean) ratios for AUC 0-tz', 'reduction in BA', 'efficacy and safety', 'area under the concentration-time curve from baseline to the last quantifiable data point (AUC 0-tz ) and maximum plasma concentration (C max ) of unconjugated dabigatran', 'tolerated; no deaths, serious adverse events (AEs) or significant AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0522530', 'cui_str': 'Unconjugated (qualifier value)'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",160.0,0.202028,"Treatment was well tolerated; no deaths, serious adverse events (AEs) or significant AEs were reported in either study. ","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Clinical PK/PD Department, Nippon Boehringer Ingelheim Co., Ltd., 6-7-5 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. akiko.harada@boehringer-ingelheim.com.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Ikushima', 'Affiliation': 'SOUSEIKAI Sumida Hospital, 1-29-1 Honjo, Sumida-ku, Tokyo, 130-0004, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'SOUSEIKAI Hakata Clinic, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Yanagihara', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakayama', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.'}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-019-00377-x'] 1288,32408883,Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation.,"BACKGROUND The clinical effectiveness of neurally adjusted ventilatory assist (NAVA) has yet to be demonstrated, and preliminary studies are required. The study aim was to assess the feasibility of a randomized controlled trial (RCT) of NAVA versus pressure support ventilation (PSV) in critically ill adults at risk of prolonged mechanical ventilation (MV). METHODS An open-label, parallel, feasibility RCT (n = 78) in four ICUs of one university-affiliated hospital. The primary outcome was mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥ 65% mode adherence). Secondary exploratory outcomes included ventilator-free days (VFDs), sedation, and mortality. RESULTS In the 72 participants who commenced weaning, median (95% CI) mode adherence was 83.1% (64.0-97.1%) and 100% (100-100%), and protocol compliance was 66.7% (50.3-80.0%) and 100% (89.0-100.0%) in the NAVA and PSV groups respectively. Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA. Although overall sedation was similar, Richmond Agitation and Sedation Scale (RASS) scores were closer to zero in NAVA compared to PSV (p = 0.020). No significant differences were observed in duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality. CONCLUSIONS This feasibility trial demonstrated good adherence to assigned ventilation mode and the ability to meet a priori protocol compliance criteria. Exploratory outcomes suggest some clinical benefit for NAVA compared to PSV. Clinical effectiveness trials of NAVA are potentially feasible and warranted. TRIAL REGISTRATION ClinicalTrials.gov, NCT01826890. Registered 9 April 2013.",2020,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","['patients at risk of prolonged mechanical ventilation', 'critically ill adults at risk of prolonged mechanical ventilation (MV', 'n\u2009=\u200978) in four ICUs of one university-affiliated hospital']","['RCT', 'neurally adjusted ventilatory assist (NAVA', 'NAVA versus pressure support ventilation (PSV', 'Neurally adjusted ventilatory assist versus pressure support ventilation', 'NAVA']","['hospital deaths', 'overall sedation', 'adherence', 'Richmond Agitation and Sedation Scale (RASS) scores', 'protocol compliance', 'mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥\u200965% mode adherence', 'ventilator-free days (VFDs), sedation, and mortality', 'VFDs to D28', 'duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.234937,"Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Hadfield', 'Affiliation': ""Critical Care, King's College Hospital, London, UK. daniel.hadfield@nhs.net.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Reid', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Faculty of Medicine, School of Public Health, Imperial College, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Finney', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Penhaligon', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Molai', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clarey', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Thompson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Hopkins', 'Affiliation': ""Critical Care, King's College Hospital, London, UK.""}, {'ForeName': 'Gerrard F', 'Initials': 'GF', 'LastName': 'Rafferty', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}]","Critical care (London, England)",['10.1186/s13054-020-02923-5'] 1289,30554300,Translation of basic research in cognitive science to HIV-risk: a randomized controlled trial.,"Many people enrolled in drug diversion programs are not receiving evidence-based prevention for HIV or hepatitis. This study translated basic research from cognitive science to increase screening for infection and condom use in this population. A parallel three-condition randomized trial was conducted in a drug diversion sample (N = 358), comparing a memory practice condition with two active control conditions. Outcomes were condom use frequency and testing for infection (hepatitis B/C, HIV). At 3-month follow-up, participants in the memory practice condition were at least twice as likely (OR = 2.10 or greater, p < .01) to self-report testing compared to those in the control conditions and also reported more frequent condom use compared to a health education condition [B = .37, t(1) = 2.02, p = .02]. Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.",2019,Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.,"['drug diversion sample (N\u2009=\u2009358), comparing a memory practice condition with two active control conditions', 'cognitive science to HIV-risk']",[],"['condom use frequency and testing for infection (hepatitis B/C, HIV']","[{'cui': 'C0680490', 'cui_str': 'Drug diversion'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376542', 'cui_str': 'Cognitive Science'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],"[{'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.0766494,Basic research on memory can be effectively translated to brief interventions on infection screening and risk prevention in existing drug diversion programs.,"[{'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Stacy', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, 675 West Foothill Boulevard, Suite 310, Claremont, CA, 91711-3475, USA. alan.stacy@cgu.edu.'}, {'ForeName': 'Liesl A', 'Initials': 'LA', 'LastName': 'Nydegger', 'Affiliation': 'Department of Kinesiology and Health Education, University of Texas, 2109 San Jacinto Blvd., Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Shono', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, 1100 NE 45th Street, Suite 300, Box 354944, Seattle, WA, 98195-4944, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9999-3'] 1290,30535188,"A Randomized, Double-blinded, Placebo-controlled Trial of Sitagliptin for Reducing Inflammation and Immune Activation in Treated and Suppressed Human Immunodeficiency Virus Infection.","BACKGROUND Dipeptidyl peptidase-4 (DPP-4) inhibitors have pleotropic anti-inflammatory and immune regulatory effects in addition to glucoregulation. We evaluated inflammation and immune markers in suppressed human immunodeficiency virus (HIV) infection during treatment with the DPP-4 inhibitor sitagliptin. METHODS Virologically suppressed adults with HIV without diabetes on stable antiretroviral therapy (ART) with ≥100/μL CD4 cells were randomized to 16 weeks of sitagliptin 100 mg/day vs placebo in a multicenter trial. The primary endpoint was the change in plasma soluble CD14 (sCD14) from baseline to week 15-16. RESULTS Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses. Participants were 45% non-Hispanic white, 38% non-Hispanic black, and 15% Hispanic, with a median age of 51 years; 83% were male; and the median CD4 count was 602 cells/μL. At week 15-16, there was no difference in sCD14 change between the 2 arms (P = .69). Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10 (95% confidence interval, -57% to -35%) at week 15 (P < .001). There were no significant between-arm differences in other soluble biomarkers, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation. Sitagliptin was well tolerated. CONCLUSIONS Sixteen weeks of sitagliptin had no effect on sCD14 levels in virologically suppressed participants with HIV. CXCL10, a chemokine involved in atherogenesis that predicts non-AIDS events during ART, declined markedly with sitagliptin. This suggests that DPP-4 inhibition has the potential to reduce cardiovascular morbidity in treated HIV infection. CLINICAL TRIALS REGISTRATION NCT01426438.",2019,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","['Evaluable participants were 45% non-Hispanic white, 38% non-Hispanic black, 15% Hispanic, median age of 51 years, 83% male, with median CD4 count 602 cells/mm 3', 'Treated and Suppressed HIV Infection', 'adults with HIV without diabetes mellitus on stable ART with ≥100/mm 3 CD4 cells', 'Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses']","['placebo', 'sitagliptin 100 mg/d vs. placebo', 'Sitagliptin', 'Placebo', 'CXCL10', '\n\n\nDipeptidyl peptidase-4 (DPP-4) inhibitors']","['cardiovascular morbidity', 'tolerated', 'CXCL10', 'sCD14 change', 'change in plasma soluble CD14 (sCD14', 'soluble CD163, soluble CD26, interleukin-6, C-reactive protein, soluble tumour necrosis factor receptors I and II, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation', 'Additional soluble biomarkers, and lymphocyte and monocyte activation', 'sCD14 levels', 'Inflammation and Immune Activation']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C3653297', 'cui_str': 'Dipeptidyl peptidase 4 (DPP-4) inhibitors'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}]",90.0,0.579292,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'University of Texas Health Science Center, Houston.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kinslow', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Floris-Moore', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Yarasheski', 'Affiliation': 'Washington University, St. Louis, Missouri.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1051'] 1291,30523414,Efficacy and safety of once-monthly risedronate in osteoporosis subjects with mild-to-moderate chronic kidney disease: a post hoc subgroup analysis of a phase III trial in Japan.,"Limited data are available on the safety and efficacy of anti-resorptive agents, particularly once-monthly bisphosphonates, for use in osteoporotic patients with chronic kidney disease (CKD). We conducted a post hoc analysis of data from a 12-month, randomized, double-blind, phase III study to evaluate the safety and efficacy of once-monthly risedronate (RIS-OM) 75 mg tablets in Japanese osteoporosis patients with mild-to-moderate CKD. Patients who received RIS-OM 75 mg were stratified by baseline estimated glomerular filtration rate (eGFR; ≥ 90, ≥ 60 to < 90, or ≥ 30 to < 60 mL/min/1.73 m 2 ). Safety endpoints were incidence of adverse events (AEs) and percent change from baseline in eGFR, serum creatinine, calcium, and phosphorus. Efficacy endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) and bone turnover markers (BTMs). In 420 patients included (age 67.7 ± 6.7 years, women 98.8%), the incidence of all AEs, gastrointestinal disorders, acute phase reaction, non-vertebral fractures, and renal and urinary disorders was not significantly different among subgroups. Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant. BMD significantly increased while BTMs significantly decreased from baseline with a similar degree of change among the subgroups. In conclusion, RIS-OM 75 mg showed consistent safety and efficacy in suppressing bone turnover and increasing BMD in Japanese primary osteoporosis patients with mild-to-moderate CKD. These results should, however, be interpreted with caution because the number of patients with moderate CKD was limited.",2019,Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant.,"['Japanese primary osteoporosis patients with mild-to-moderate CKD', 'Japanese osteoporosis patients with mild-to-moderate CKD', 'eGFR; ≥ 90, ≥ 60 to\u2009< 90, or\u2009≥ 30 to', '420 patients included (age 67.7\u2009±\u20096.7\xa0years, women 98.8', 'osteoporotic patients with chronic kidney disease (CKD', 'osteoporosis subjects with mild-to-moderate chronic kidney disease']","['RIS-OM', 'risedronate', 'risedronate (RIS-OM']","['serum creatinine', 'safety and efficacy', 'lumbar spine bone mineral density (BMD) and bone turnover markers (BTMs', 'BMD', 'bone turnover and increasing BMD', 'eGFR', 'Efficacy and safety', 'incidence of all AEs, gastrointestinal disorders, acute phase reaction, non-vertebral fractures, and renal and urinary disorders', 'glomerular filtration rate', 'BTMs', 'incidence of adverse events (AEs) and percent change from baseline in eGFR, serum creatinine, calcium, and phosphorus']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0246719', 'cui_str': 'Risedronate'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0001349', 'cui_str': 'Response, Acute-Phase'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0042075', 'cui_str': 'Urological Diseases'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}]",420.0,0.0565696,Interaction between subgroups and time was significant for eGFR (p = 0.010) and serum creatinine (p = 0.001) but considered to be regression to the mean and clinically insignificant.,"[{'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Internal Medicine, 1, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Inoue', 'Affiliation': 'Third Department of Medicine, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara-shi, Chiba, 299-0111, Japan. inoued@med.teikyo-u.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Maehara', 'Affiliation': 'EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oikawa', 'Affiliation': 'EA Pharma Co., Ltd., 2-1-1 Irifune, Chuo-ku, Tokyo, 104-0042, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigematsu', 'Affiliation': 'Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama, 641-8509, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-018-0977-1'] 1292,30079432,Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.,"BACKGROUND Preliminary evidence suggested that the PPARγ agonist pioglitazone reduces opioid-withdrawal symptoms, possibly by inhibiting increases in proinflammatory cytokines. METHODS A randomized, placebo-controlled clinical trial was conducted utilizing two different study designs (entirely outpatient, and a combination of inpatient and outpatient) to evaluate the safety and efficacy of pioglitazone as an adjunct medication for people with opioid physical dependence undergoing a buprenorphine taper. Participants were stabilized on buprenorphine/naloxone (sublingual, up to 16/4 mg/day), then randomized to receive oral pioglitazone (up to 45 mg/day) or placebo before, during, and after buprenorphine taper. Outcome measures included the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale, use of rescue medications to alleviate opioid withdrawal symptoms, and opioid-positive urine specimens. Cerebrospinal fluid (CSF) and plasma were collected during the taper in a subset of participants for measurement of proinflammatory cytokines. RESULTS The clinical trial was prematurely terminated due to slow enrollment; 40 participants per group were required for adequate statistical power to test study hypotheses. Twenty-four participants enrolled; 17 received at least one dose of study medication (6 pioglitazone, 11 placebo). SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase. SOWS scores were positively correlated with monocyte chemoattractant protein-1 (MCP-1) in CSF (r = 0.70, p = 0.038) and plasma (r = 0.77, p = 0.015). Participants having higher levels of plasma MCP-1 reported higher SOWS, most notably after the buprenorphine taper ended. CONCLUSIONS Results from this study provide no evidence that pioglitazone reduces opioid withdrawal symptoms during buprenorphine taper. High correlations between MCP-1 and opioid withdrawal symptoms support a role of proinflammatory processes in opioid withdrawal. TRIAL REGISTRATION clinicaltrials.gov identifier: NCT01517165.",2018,SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase.,"['Twenty-four participants enrolled; 17 received at least one dose of study medication (6', 'patients with opioid use disorder', 'people with opioid physical dependence undergoing a buprenorphine taper']","['buprenorphine taper', 'pioglitazone, 11 placebo', 'placebo', 'oral pioglitazone', 'pioglitazone', 'buprenorphine', 'buprenorphine/naloxone (sublingual', 'PPARγ agonist pioglitazone']","['safety and efficacy', 'opioid withdrawal symptoms', 'Cerebrospinal fluid (CSF) and plasma', 'SOWS scores', 'rescue medications', 'Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale, use of rescue medications to alleviate opioid withdrawal symptoms, and opioid-positive urine specimens', 'monocyte chemoattractant protein-1 (MCP-1) in CSF']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0007807'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0222045'}, {'cui': 'C3472219', 'cui_str': 'Clinical opiate withdrawal scale (assessment scale)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}]",24.0,0.541289,SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase.,"[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Schroeder', 'Affiliation': 'Johns Hopkins Bayview Medical Center, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Karran A', 'Initials': 'KA', 'LastName': 'Phillips', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Epstein', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Jobes', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Melody A', 'Initials': 'MA', 'LastName': 'Furnari', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Kennedy', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, IKE, Linköping Univ, 58183, Linköping, Sweden.'}, {'ForeName': 'Kenzie L', 'Initials': 'KL', 'LastName': 'Preston', 'Affiliation': 'National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, 251 Bayview Blvd., BRC Building, Suite 200, Baltimore, MD, 21224, USA. kpreston@intra.nida.nih.gov.'}]",Psychopharmacology,['10.1007/s00213-018-4986-5'] 1293,30536917,Organisation of health services for preventing and treating pressure ulcers.,"BACKGROUND Pressure ulcers, which are a localised injury to the skin, or underlying tissue, or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful, expensive to manage and have a negative impact on quality of life. While individual patient safety and quality care stem largely from direct healthcare practitioner-patient interactions, each practitioner-patient wound-care contact may be constrained or enhanced by healthcare organisation of services. Research is needed to demonstrate clearly the effect of different provider-orientated approaches to pressure ulcer prevention and treatment. OBJECTIVES To assess the effects of different provider-orientated interventions targeted at the organisation of health services, on the prevention and treatment of pressure ulcers. SEARCH METHODS In April 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched three clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA Randomised controlled trials (RCTs), cluster-RCTs, non-RCTs, controlled before-and-after studies and interrupted time series, which enrolled people at risk of, or people with existing pressure ulcers, were eligible for inclusion in the review. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence. MAIN RESULTS The search yielded a total of 3172 citations and, following screening and application of the inclusion and exclusion criteria, we deemed four studies eligible for inclusion. These studies reported the primary outcome of pressure ulcer incidence or pressure ulcer healing, or both.One controlled before-and-after study explored the impact of transmural care (a care model that provided activities to support patients and their family/partners and activities to promote continuity of care), among 62 participants with spinal cord injury. It is unclear whether transmural care leads to a difference in pressure ulcer incidence compared with usual care (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.53 to 1.64; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).One RCT explored the impact of hospital-in-the-home care, among 100 older adults. It is unclear whether hospital-in-the-home care leads to a difference in pressure ulcer incidence risk compared with hospital admission (RR 0.32, 95% CI 0.03 to 2.98; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).A third study (cluster-randomised stepped-wedge trial), explored the impact of being cared for by enhanced multidisciplinary teams (EMDT), among 161 long-term-care residents. The analyses of the primary outcome used measurements of 201 pressure ulcers from 119 residents. It is unclear if EMDT reduces the pressure ulcer incidence rate compared with usual care (hazard ratio (HR) 1.12, 95% CI 0.74 to 1.68; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the number of wounds healed (RR 1.69, 95% CI 1.00 to 2.87; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the reduction in surface area, with and without EMDT, (healing rate 1.006; 95% CI 0.99 to 1.03; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if EMDT leads to a difference in time to complete healing (HR 1.48, 95% CI 0.79 to 2.78, very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).The final study (quasi-experimental cluster trial), explored the impact of multidisciplinary wound care among 176 nursing home residents. It is unclear whether there is a difference in the number of pressure ulcers healed between multidisciplinary care, or usual care (RR 1.18, 95% CI 0.98 to 1.42; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if this type of care leads to a difference in time to complete healing compared with usual care (HR 1.73, 95% CI 1.20 to 2.50; very low-certainty evidence; downgraded twice for very serious study limitations and twice for very serious imprecision).In all studies the certainty of the evidence is very low due to high risk of bias and imprecision. We downgraded the evidence due to study limitations, which included selection and attrition bias, and sample size. Secondary outcomes, such as adverse events were not reported in all studies. Where they were reported it was unclear if there was a difference as the certainty of evidence was very low. AUTHORS' CONCLUSIONS Evidence for the impact of organisation of health services for preventing and treating pressure ulcers remains unclear. Overall, GRADE assessments of the evidence resulted in judgements of very low-certainty evidence. The studies were at high risk of bias, and outcome measures were imprecise due to wide confidence intervals and small sample sizes, meaning that additional research is required to confirm these results. The secondary outcomes reported varied across the studies and some were not reported. We judged the evidence from those that were reported (including adverse events), to be of very low certainty.",2018,It is unclear if EMDT reduces the pressure ulcer incidence rate compared with usual care (hazard ratio (HR),"['119 residents', 'enrolled people at risk of, or people with existing pressure ulcers', '100 older adults', '62 participants with spinal cord injury', '161 long-term-care residents', '176 nursing home residents']",[],"['pressure ulcer incidence or pressure ulcer healing', 'adverse events', 'pressure ulcer incidence', 'pressure ulcer incidence rate', 'number of wounds healed']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0023977'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],"[{'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0574776', 'cui_str': 'Wound healed (finding)'}]",62.0,0.124231,It is unclear if EMDT reduces the pressure ulcer incidence rate compared with usual care (hazard ratio (HR),"[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Joyce', 'Affiliation': 'School of Medicine, Royal College of Surgeons in Ireland, 121 St. Stephens Green, Dublin, Ireland, 2.'}, {'ForeName': 'Zena Eh', 'Initials': 'ZE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Christie', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012132.pub2'] 1294,29164798,Regionally specific changes in the hippocampal circuitry accompany progression of cerebrospinal fluid biomarkers in preclinical Alzheimer's disease.,"Neuropathological and in vivo brain imaging studies agree that the cornu ammonis 1 and subiculum subfields of the hippocampus are most vulnerable to atrophy in the prodromal phases of Alzheimer's disease (AD). However, there has been limited investigation of the structural integrity of the components of the hippocampal circuit, including subfields and extra-hippocampal white matter structure, in relation to the progression of well-accepted cerebrospinal fluid (CSF) biomarkers of AD, amyloid-β 1-42 (Aβ) and total-tau (tau). We investigated these relationships in 88 aging asymptomatic individuals with a parental or multiple-sibling familial history of AD. Apolipoprotein (APOE) ɛ4 risk allele carriers were identified, and all participants underwent cognitive testing, structural magnetic resonance imaging, and lumbar puncture for CSF assays of tau, phosphorylated-tau (p-tau) and Aβ. Individuals with a reduction in CSF Aβ levels (an indicator of amyloid accretion into neuritic plaques) as well as evident tau pathology (believed to be linked to neurodegeneration) exhibited lower subiculum volume, lower fornix microstructural integrity, and a trend towards lower cognitive score than individuals who showed only reduction in CSF Aβ. In contrast, persons with normal levels of tau showed an increase in structural MR markers in relation to declining levels of CSF Aβ. These results suggest that hippocampal subfield volume and extra-hippocampal white matter microstructure demonstrate a complex pattern where an initial volume increase is followed by decline among asymptomatic individuals who, in some instances, may be a decade or more away from onset of cognitive or functional impairment.",2018,"In contrast, persons with normal levels of tau showed an increase in structural MR markers in relation to declining levels of CSF Aβ.",['88 aging asymptomatic individuals with a parental or multiple-sibling familial history of AD'],[],"['structural MR markers', 'Aβ) and total-tau (tau']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]",88.0,0.0395945,"In contrast, persons with normal levels of tau showed an increase in structural MR markers in relation to declining levels of CSF Aβ.","[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Tardif', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Devenyi', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': 'Robert S C', 'Initials': 'RSC', 'LastName': 'Amaral', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Pelleieux', 'Affiliation': 'Centre for the Studies on the Prevention of AD, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': 'Judes', 'Initials': 'J', 'LastName': 'Poirier', 'Affiliation': 'Centre for the Studies on the Prevention of AD, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rosa-Neto', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Breitner', 'Affiliation': ''}, {'ForeName': 'M Mallar', 'Initials': 'MM', 'LastName': 'Chakravarty', 'Affiliation': 'Cerebral Imaging Centre, Douglas Mental Health University Institute, Verdun, Quebec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.23897'] 1295,27820659,No Increase in Fractures After Stopping Hormone Therapy: Results From the Women's Health Initiative.,"Context The Women's Health Initiative (WHI) hormone therapy (HT) trials showed protection against hip and total fractures, but a later observational report suggested loss of benefit and a rebound increased risk after cessation of HT. Objective The purpose of this study was to examine fractures after discontinuation of HT. Design and Setting Two placebo-controlled randomized trials served as the study setting. Patients Study patients included WHI participants (N = 15,187) who continued active HT or placebo through the intervention period and who did not take HT in the postintervention period. Interventions Trial interventions included conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) in naturally menopausal women and CEE alone in women with prior hysterectomy. Main Outcome Measures Total fractures and hip fractures through 5 years after discontinuation of HT were recorded. Results Hip fractures were infrequent (∼2.5 per 1000 person-years); this finding was similar between trials and in former HT and placebo groups. There was no difference in total fractures in the CEE + MPA trial for former HT vs former placebo users (28.9 per 1000 person-years and 29.9 per 1000 person-years, respectively; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.87 to 1.09; P = 0.63); however, in the CEE-alone trial, total fractures were higher in former placebo users (36.9 per 1000 person-years) compared with the former active group (31.1 per 1000 person-years), a finding that was suggestive of a residual benefit of CEE against total fractures (HR, 0.85; 95% CI, 0.73 to 0.98; P = 0.03). Conclusions We found no evidence for increased fracture risk, either sustained or transient, for former HT users compared with former placebo users after stopping HT. There was residual benefit for total fractures in former HT users from the CEE-alone study.",2017,"We found no evidence for increased fracture risk, either sustained or transient, for former HT users compared with former placebo users after stopping HT.","['Patients\n\n\nStudy patients included WHI participants (N = 15,187) who continued active HT or placebo through the intervention period and who did not take HT in the postintervention period', 'naturally menopausal women and CEE alone in women with prior hysterectomy']","['conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA', 'placebo']","['Hip fractures', 'Total fractures and hip fractures', 'Fractures', 'total fractures', 'fracture risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",15187.0,0.313231,"We found no evidence for increased fracture risk, either sustained or transient, for former HT users compared with former placebo users after stopping HT.","[{'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Mercy Health Osteoporosis and Bone Health Services, Cincinnati, Ohio 45236.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania 15261.'}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, The Ohio State University, Columbus, Ohio 43210.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': ""Women's Health Center of Excellence, Family Medicine and Public Health, University of California, San Diego, La Jolla, California 92093.""}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 35294.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.""}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Neuner', 'Affiliation': 'Medical College of Wisconsin Cancer Center Population Science, Division of General Internal Medicine and Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, Wisconsin 53226.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Phillips', 'Affiliation': 'Atlanta VA Medical Center, Decatur, Georgia 30033.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California 94305.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, University at Buffalo, State University of New York, Buffalo, New York 14214; and.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Crandall', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California 90095.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2016-3270'] 1296,31659595,"Gluten-Free Diet in Children with Autism Spectrum Disorders: A Randomized, Controlled, Single-Blinded Trial.","To determine whether a gluten-free diet (GFD) compared with a gluten-containing diet (GD) influences functioning of children with autism spectrum disorders (ASD), we performed a randomized, controlled, single-blinded trial. Sixty-six children (36-69 months) with ASD, within the normal IQ (> 70) range, who had been on a GFD for at least 8 weeks before enrollment were eligible for inclusion. After an 8-week run-in period on a GFD, the GFD group continued this diet and the GD group consumed at least one normal meal containing gluten per day for 6 months. There were no differences between groups in autistic symptoms, maladaptive behaviors, or intellectual abilities after the intervention. A GFD compared with a GD did not affect functioning of children with ASD.Trial registration ClinicalTrials.gov, number NCT02280746.",2020,"There were no differences between groups in autistic symptoms, maladaptive behaviors, or intellectual abilities after the intervention.","['Spectrum Disorders', 'children with autism spectrum disorders (ASD', 'Sixty-six children (36-69\xa0months) with ASD, within the normal IQ (>\u200970) range, who had been on a GFD for at least 8\xa0weeks before enrollment were eligible for inclusion', 'Children with Autism']","['gluten-containing diet (GD', 'gluten-free diet (GFD', 'Gluten-Free Diet']","['autistic symptoms, maladaptive behaviors, or intellectual abilities']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0562443', 'cui_str': 'Maladaptive behavior (finding)'}, {'cui': 'C0423898', 'cui_str': 'Intellectual ability (observable entity)'}]",66.0,0.308882,"There were no differences between groups in autistic symptoms, maladaptive behaviors, or intellectual abilities after the intervention.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piwowarczyk', 'Affiliation': 'Department of Paediatrics with Clinical Assessment Unit, The Medical University of Warsaw, Zwirki i Wigury 63a, 02-091, Warsaw, Poland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Zwirki i Wigury 63A, 02-091, Warsaw, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pisula', 'Affiliation': 'Department of Health and Rehabilitation Psychology, Faculty of Psychology, University of Warsaw, Stawki 5/7, 00-183, Warsaw, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Kawa', 'Affiliation': 'Department of Health and Rehabilitation Psychology, Faculty of Psychology, University of Warsaw, Stawki 5/7, 00-183, Warsaw, Poland.'}, {'ForeName': 'Hania', 'Initials': 'H', 'LastName': 'Szajewska', 'Affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Zwirki i Wigury 63A, 02-091, Warsaw, Poland. hania@ipgate.pl.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04266-9'] 1297,32409002,A novel EML4-ALK BIRC6-ALK double fusion variant in lung adenocarcinoma confers sensitivity to alectinib.,,2020,,[],"['BIRC6-ALK', 'EML4-ALK']",[],[],"[{'cui': 'C0910612', 'cui_str': 'BIRC6 protein, human'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]",[],,0.0427387,,"[{'ForeName': 'Jiang-Ming', 'Initials': 'JM', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Gui-Feng', 'Initials': 'GF', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'De-Yu', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China. Electronic address: liuzhenhua6909@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.04.030'] 1298,30554932,"Is regional ankle block needed in conjunction with general anaesthesia for first ray surgery? A randomised controlled trial of ultrasound guided ankle block versus ""blind"" local infiltration.","BACKGROUND Regional anaesthesia is commonly utilised for foot and ankle surgery. Debate remains at to the level of regional anaesthesia that is required. The objective of this study was to evaluate whether surgeon-delivered ""blind"" local anaesthetic infiltration around the first ray (metatarsal block without ultrasound guidance) was as effective as an ultrasound guided ankle block in providing post-operative analgesia after osseous first ray surgery performed under general anaesthetic. METHODS 50 patients were recruited to a single surgeon and anaesthetist double-blinded randomised controlled trial at a single-centre. 20mls of 0.5% levobupivacaine was used to perform either an ankle or metatarsal nerve block. RESULTS Forty-eight patients completed the study: 25 in the ankle block treatment arm and 23 in the metatarsal block arm. The demographics were comparable between groups. There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block). Metatarsal block groups had a faster return of normal sensation (2.3 vs 2.8h) but there was no difference in time to safe mobilisation (2.6 vs 2.8h). CONCLUSION This study demonstrates the efficacy and safety of surgeon delivered ""blind"" metatarsal block is comparable to an ultrasound guided ankle block for first ray surgery performed under general anaesthetic. LEVEL OF EVIDENCE 1.",2020,"There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block).","['50 patients were recruited to a single surgeon and anaesthetist double-blinded randomised controlled trial at a single-centre', 'Forty-eight patients completed the study: 25 in the ankle block treatment arm and 23 in the metatarsal block arm']","['ultrasound guided ankle block versus ""blind"" local infiltration', 'levobupivacaine', 'surgeon-delivered ""blind"" local anaesthetic infiltration around the first ray (metatarsal block without ultrasound guidance', 'surgeon delivered ""blind"" metatarsal block']","['faster return of normal sensation', 'efficacy and safety', 'time to safe mobilisation', 'visual analogue pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0473161', 'cui_str': 'Anesthetist'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block (procedure)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0450284', 'cui_str': 'First ray (body structure)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0576709', 'cui_str': 'Normal sensation (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",50.0,0.391939,"There was no statistical difference in visual analogue pain scores at two (21.3 vs 15.2), six (23.6 vs 20.8) and 24 (42.2 vs 50.4) hours following the procedure between the two groups (metatarsal block vs ankle block).","[{'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Roberts', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Randeep S', 'Initials': 'RS', 'LastName': 'Aujla', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK. Electronic address: Randeep.aujla@hotmail.co.uk.'}, {'ForeName': 'Felix N', 'Initials': 'FN', 'LastName': 'Fombon', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Bhatia', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2018.11.012'] 1299,28456387,Erythropoietin and Brain Magnetic Resonance Imaging Findings in Hypoxic-Ischemic Encephalopathy: Volume of Acute Brain Injury and 1-Year Neurodevelopmental Outcome.,"In the Neonatal Erythropoietin and Therapeutic Hypothermia Outcomes study, 9/20 erythropoietin-treated vs 12/24 placebo-treated infants with hypoxic-ischemic encephalopathy had acute brain injury. Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004). Higher injury volume correlated with lower 12-month neurodevelopmental scores. TRIAL REGISTRATION ClinicalTrials.gov: NCT01913340.",2017,"Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004).","['treated infants with hypoxic-ischemic encephalopathy had acute brain injury', 'Hypoxic-Ischemic Encephalopathy']","['Erythropoietin and Brain Magnetic Resonance Imaging Findings', 'placebo', 'erythropoietin-treated vs 12/24 placebo']",['injury volume'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0085742', 'cui_str': 'Injuries, Acute Brain'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.296562,"Among infants with acute brain injury, the injury volume was lower in the erythropoietin than the placebo group (P = .004).","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Division of Fetal and Transitional Medicine, Children's National Health System, Washington, DC; University of Arkansas for Medical Sciences, Little Rock, AR. Electronic address: sbmulkey@childrensnational.org.""}, {'ForeName': 'Raghu H', 'Initials': 'RH', 'LastName': 'Ramakrishnaiah', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McKinstry', 'Affiliation': 'Washington University, St. Louis, MO.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Division of Fetal and Transitional Medicine, Children's National Health System, Washington, DC.""}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Washington University, St. Louis, MO.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': 'Stanford University, Palo Alto, CA.'}, {'ForeName': 'G Bradley', 'Initials': 'GB', 'LastName': 'Schaefer', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Chunqiao', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2017.03.053'] 1300,30351169,A Randomized Trial of Prenatal Video Education to Improve Breastfeeding Among Low-Income Women.,"Background: Many women initiate breastfeeding but do not meet their duration goals, and low-income women initiate and continue breastfeeding at lower rates than their counterparts. One-on-one counseling is associated with increased breastfeeding but requires significant resources. In contrast, video education, which requires fewer resources and is effective in other health care settings, such as vaccine uptake, has gone untested for prolonging breastfeeding duration among low-income women. Objective: To determine whether use of an educational breastfeeding video shown individually to low-income pregnant women in the prenatal clinic would prolong duration of any and exclusive breastfeeding. Methods: A multicenter, randomized, controlled trial was conducted in four prenatal clinics. Low-income pregnant women were randomized to view the intervention (breastfeeding education) or control (prenatal nutrition) video in the third trimester and interviewed by telephone at 1, 3, and 6 months postpartum about infant feeding practices. Kaplan-Meier survival curves with log-rank tests and Cox proportional hazards regression were utilized to compare groups. Results: Of the 816 eligible women approached, 64% participated: 263 assigned to the intervention, and 259 assigned to the control. Six-month data were obtained for 211 (80%) and 220 (85%) women, respectively. Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively). Conclusion: A single viewing of a breastfeeding education video shown in the prenatal clinic did not impact breastfeeding duration or exclusivity among low-income women in this study. Although not sufficient alone, educational videos may be useful as one component of a comprehensive program to promote breastfeeding.",2018,"Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively). ","['four prenatal clinics', '816 eligible women approached', 'Low-Income Women', 'low-income pregnant women in the prenatal clinic', 'Low-income pregnant women']","['intervention (breastfeeding education) or control (prenatal nutrition) video in the third trimester and interviewed by telephone', 'Prenatal Video Education', 'educational breastfeeding video']","['Kaplan-Meier survival curves', 'Rate of breastfeeding cessation']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0418914', 'cui_str': 'Lactation education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]",816.0,0.0894403,"Rate of breastfeeding cessation did not differ by group (hazard ratios; HR = 1.00, 95% confidence interval [CI]: 0.81-1.24 and HR = 0.93, 95% CI: 0.76-1.14, for any and exclusive breastfeeding, respectively). ","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Kellams', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Gurka', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Paige P', 'Initials': 'PP', 'LastName': 'Hornsby', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Drake', 'Affiliation': 'School of Nursing, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2018.0115'] 1301,32409111,Melatonin and melatonin agonists as treatments for benzodiazepines and hypnotics withdrawal in patients with primary insomnia. A systematic review.,"BACKGROUND Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once established. Melatonin (MLT) has been prescribed as a treatment for BZD/HYP detoxification. AIMS The primary objective of this systematic review is to assess the efficacy of MLT and MLT agonists (melatoninergics) in improving the rate of BZD and/or HYP discontinuation among adults with primary insomnia attempting to discontinue BZD and/or HYP. The secondary objective is to evaluate the partial efficacy of melatoninergic drugs in the discontinuation of BZD and/or HYP consumption in subjects that could not stop their consumption. METHOD A search on Web of Science and Scopus was carried out from database inception to July 1st, 2019. RESULTS Three hundred and forty-nine articles were identified but only four were included in the final review. Two were cohort prospective, one placebo-control double blind and one double blind placebo-control cross-over designed study. Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm. In cohort studies TW figures ranged from 30.8% to 65%. Partial withdrawal ranged between 20% and 30.8% of patients that did not achieve TW with reduction figures of diazepam equivalent dose ranging from 25% to 75%. CONCLUSION MLT has a place in the physician armamentarium to treat the suspension/reduction of BZD/HYP consumption in patients with primary insomnia.",2020,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"['patients with primary insomnia', 'Three hundred and forty-nine articles were identified but only four were included in the final review', 'adults with primary insomnia attempting to discontinue BZD and/or HYP', 'subjects that could not stop their consumption']","['MLT and MLT agonists (melatoninergics', 'placebo-control double blind and one double blind placebo-control cross', 'MLT', 'Melatonin and melatonin agonists', 'diazepam', 'Melatonin (MLT', 'benzodiazepines', 'Hypnotics (HYP) and benzodiazepines (BZD', 'placebo']","['rate of BZD and/or HYP discontinuation', 'Total withdrawal (TW', 'Partial withdrawal ranged']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1635027', 'cui_str': 'Melatonin agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",349.0,0.110412,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"[{'ForeName': 'Armando L', 'Initials': 'AL', 'LastName': 'Morera-Fumero', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Consultoría Psiquiátrica SC, Santa Cruz de Tenerife, Spain. Electronic address: amorera@ull.edu.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Fernandez-Lopez', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Sociedad para la Investigación y Asistencia en Salud Mental, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Gonzalez', 'Affiliation': 'Departamento de Ciencias Médicas Básicas: Unidad de Fisiología. Facultad de Ciencias de la Salud. Universidad de la Laguna, la Laguna, Santa Cruz de Tenerife, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107994'] 1302,30133058,The system-neurophysiological basis for how methylphenidate modulates perceptual-attentional conflicts during auditory processing.,"The ability to selectively perceive and flexibly attend to relevant sensory signals in the environment is essential for action control. Whereas neuromodulation of sensory or attentional processing is often investigated, neuromodulation of interactive effects between perception and attention, that is, high attentional control demand when the relevant sensory information is perceptually less salient than the irrelevant one, is not well understood. To fill this gap, this pharmacological-electroencephalogram (EEG) study applied an intensity-modulated, focused-attention dichotic listening paradigm together with temporal EEG signal decomposition and source localization analyses. We used a double-blind MPH/placebo crossover design to delineate the effects of methylphenidate (MPH)-a dopamine/norepinephrine transporter blocker-on the resolution of perceptual-attentional conflicts, when perceptual saliency and attentional focus favor opposing ears, in healthy young adults. We show that MPH increased behavioral performance specifically in the condition with the most pronounced conflict between perceptual saliency and attentional focus. On the neurophysiological level, MPH effects in line with the behavioral data were observed after accounting for intraindividual variability in the signal. More specifically, MPH did not show an effect on stimulus-related processes but modulated the onset latency of processes between stimulus evaluation and responding. These modulations were further shown to be associated with activation differences in the temporoparietal junction (BA40) and the superior parietal cortex (BA7) and may reflect neuronal gain modulation principles. The findings provide mechanistic insights into the role of modulated dopamine/norepinephrine transmitter systems for the interactions between perception and attention.",2018,These modulations were further shown to be associated with activation differences in the temporoparietal junction (BA40) and the superior parietal cortex (BA7) and may reflect neuronal gain modulation principles.,['healthy young adults'],"['methylphenidate (MPH)-a dopamine/norepinephrine transporter blocker', 'methylphenidate', 'placebo']","['behavioral performance', 'neurophysiological level, MPH effects']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0132800', 'cui_str': 'Norepinephrine Plasma Membrane Transport Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.056993,These modulations were further shown to be associated with activation differences in the temporoparietal junction (BA40) and the superior parietal cortex (BA7) and may reflect neuronal gain modulation principles.,"[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Adelhöfer', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Krutika', 'Initials': 'K', 'LastName': 'Gohil', 'Affiliation': 'Faculty of Psychology, Chair of Lifespan Developmental Neuroscience, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Passow', 'Affiliation': 'Faculty of Psychology, Chair of Lifespan Developmental Neuroscience, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Teufert', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Shu-Chen', 'Initials': 'SC', 'LastName': 'Li', 'Affiliation': 'Faculty of Psychology, Chair of Lifespan Developmental Neuroscience, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Faculty of Medicine, Department of Child and Adolescent Psychiatry, TU Dresden, Dresden, Germany.'}]",Human brain mapping,['10.1002/hbm.24344'] 1303,31001633,Persistence of Antibodies to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: 1-Year Follow-up With Memory Probe Vaccination.,"BACKGROUND We previously reported the tolerability and immunogenicity 1 month after intramuscular administration of 2 bivalent virus-like particle (VLP)-based candidate norovirus vaccine formulations in adults. We now describe the persistence of immunity and responses to a memory probe vaccination 1 year later. METHODS A total of 454 healthy men and women aged 18-49 years in 3 equal groups received placebo (saline) or 15/50 or 50/50 vaccine formulations (ie, 15 or 50 µg of GI.1 genotype VLPs, respectively, and 50 µg of GII.4c VLPs) with MPL and Al(OH)3. Immunogenicity and safety were assessed up to day 365, when 351 participants received a memory probe vaccination of 15 µg each of GI.1 and GII.4c VLPs with Al(OH)3. RESULTS No safety signals were detected up to 1 year after the first vaccination. Pan-immunoglobulin, immunoglobulin A, and histo-blood group antigen-blocking (HBGA) antibody levels among vaccinees waned but remained higher than levels before vaccination and levels in placebo recipients on days 180 and 365. Memory probe vaccination increased all antibody titers. Levels of HBGA antibodies to GI.1 but not GII.4c were higher after the first vaccination in candidate vaccine groups, compared with those in the placebo group. CONCLUSION Levels of antibodies to both candidate norovirus VLP formulations persisted above baseline levels for at least 1 year after primary vaccination. HBGA-blocking responses to the memory probe for GI.1 but not GII.4c displayed characteristics of immune memory. CLINICAL TRIALS REGISTRATION NCT02142504.",2019,"HBGA antibodies to GI.1, but not GII.4c, were higher in candidate vaccine groups than the placebo group receiving their first NoV vaccination. ","['351 participants received a', 'Healthy 18-49 year-olds (N=454) in three equal groups received', 'healthy adults', 'adults']","['memory probe vaccination of 15µg each of GI.1 and GII.4c VLPs with Al(OH)3', 'Virus-Like Particle norovirus vaccine candidate formulations', 'placebo (saline) or 15/50 or 50/50 vaccine formulations', 'placebo']","['antibody titers', 'Immunogenicity and safety']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0077287', 'cui_str': 'tris(acetylacetonate) aluminum(III)'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles (morphologic abnormality)'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.21131,"HBGA antibodies to GI.1, but not GII.4c, were higher in candidate vaccine groups than the placebo group receiving their first NoV vaccination. ","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Baehner', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lloyd', 'Affiliation': 'Takeda Vaccines, Deerfield, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Mendelman', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiz170'] 1304,30183463,Self-Care System for Family Caregivers of Cancer Patients Using Resonant Breathing with a Portable Home Device: A Randomized Open-Label Study.,"BACKGROUND Self-care systems for early-stage specialist palliative care for cancer patients and their family caregivers have received much attention recently. Resonant breathing is an established method for maximizing heart rate variability (HRV), but it has not been implemented for home self-care. OBJECTIVE We aimed to examine the usefulness and ease of implementation for family caregivers to administer resonant breathing using a portable device at home. DESIGN We divided caregivers into two groups-a home self-care group and a control group-and we conducted a randomized open-label study, with rate of change in HRV being the primary outcome. SETTING/SUBJECTS We administered HRV biofeedback (HRV-BF) using resonant breathing to 54 family caregivers who felt burdened by their nursing care responsibilities. RESULTS Among the self-care group, 92.6% of participants completed the study in their homes; 28 days after intervention initiation, the resonant breathing implementation rate at home was 86.1%. There was an interaction between time course and grouping in our HRV comparisons: the change rate in the home self-care group was higher during HRV-BF than before HRV-BF. CONCLUSIONS Because family caregivers in our study learned to quickly administer resonant breathing using a portable device at home, resonant breathing improved rapidly, along with autonomic nerve function and quality of life.",2019,"We administered HRV biofeedback (HRV-BF) using resonant breathing to 54 family caregivers who felt burdened by their nursing care responsibilities. ","['54 family caregivers who felt burdened by their nursing care responsibilities', 'cancer patients and their family caregivers', 'Family Caregivers of Cancer Patients']","['Resonant Breathing with a Portable Home Device', 'Self-Care System', 'HRV biofeedback (HRV-BF) using resonant breathing', 'home self-care group and a control group', 'Resonant breathing']",['resonant breathing implementation rate'],"[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0577554', 'cui_str': 'Resonant (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0577554', 'cui_str': 'Resonant (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]",54.0,0.0467338,"We administered HRV biofeedback (HRV-BF) using resonant breathing to 54 family caregivers who felt burdened by their nursing care responsibilities. ","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hasuo', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kanbara', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uchitani', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}, {'ForeName': 'Mikihiko', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Psychosomatic Medicine, Kansai Medical University , Osaka, Japan .'}]",Journal of palliative medicine,['10.1089/jpm.2018.0230'] 1305,30318190,Comparison and Assessment of Flixweed and Fig Effects on Irritable Bowel Syndrome with Predominant Constipation: A Single-Blind Randomized Clinical Trial.,"BACKGROUND Irritable bowel syndrome with predominant constipation (IBS-C) is a common digestive disorder. The current therapy is inadequate and evidence regarding the effect of herbal therapies on the relief of affected individuals is insufficient. The aim of this study was to investigate the beneficial effects of flixweed and fig consumption on IBS-C symptoms. METHODS 150 patients with IBS-C were enrolled in this randomized, controlled trial. All patients were randomly assigned to three groups and received an intervention for four months. The IBS severity score system and quality-of-life questionnaires were used for evaluating IBS-C symptoms. C-reactive protein levels, frequency of defecation and hard stool were also assessed. RESULTS Consumption of flixweed or fig, compared to a control group, caused a significant improvement in IBS symptoms including frequency of pain, distention, frequency of defecation and hard stool. Also, the findings showed a significant increase in quality of life, as well as satisfaction with overall bowel habits. However, flixweed and fig intake had no significant effects on abdominal pain severity and C-reactive protein levels. CONCLUSIONS In conclusion, consumption of flixweed or fig for four months would be a useful therapy for alleviating IBS-C symptoms and can be a beneficial option for first-line treatment.",2019,"However, flixweed and fig intake had no significant effects on abdominal pain severity and C-reactive protein levels. ","['150 patients with IBS-C', 'Irritable Bowel Syndrome with Predominant Constipation']",['flixweed and fig consumption'],"['IBS symptoms including frequency of pain, distention, frequency of defecation and hard stool', 'IBS severity score system and quality-of-life questionnaires', 'satisfaction with overall bowel habits', 'C-reactive protein levels, frequency of defecation and hard stool', 'quality of life', 'abdominal pain severity and C-reactive protein levels']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0581872', 'cui_str': 'Frequency of defecation (observable entity)'}, {'cui': 'C0278016', 'cui_str': 'Hard stool (finding)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",150.0,0.0907501,"However, flixweed and fig intake had no significant effects on abdominal pain severity and C-reactive protein levels. ","[{'ForeName': 'Makan', 'Initials': 'M', 'LastName': 'Pourmasoumi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghiasvand', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: ghiasvand@hlth.mui.ac.ir.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Darvishi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nimah', 'Initials': 'N', 'LastName': 'Bahreini', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ziyaaddin', 'Initials': 'Z', 'LastName': 'Keshavarzpour', 'Affiliation': 'Faculty of Health & Nutrition, Bushehr University of Medical Sciences, Bushehr, Iran.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2018.09.003'] 1306,31862830,Middle meningeal artery embolization as an adjuvant treatment to surgery for symptomatic chronic subdural hematoma: a pilot study assessing hematoma volume resorption.,"BACKGROUND Chronic subdural hematoma (CSDH) is a common condition requiring surgical treatment; however, recurrence occurs in 15% of cases at 1 year. Middle meningeal artery (MMA) embolization has recently emerged as a promising treatment to prevent CSDH recurrence. OBJECTIVE To investigate the effect of MMA embolization on hematoma volume resorption (HVR) after surgery in symptomatic patients. METHODS From April 2018 to October 2018, participants with CSDH requiring surgery were prospectively randomized in a pilot study, and received either surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group). The primary outcome was HVR measured on the 3 month CT scan compared with the immediate pre-embolization CT scan. Secondary outcomes were clinical recurrence of CSDH and safety measures. RESULTS 46 patients were randomized and 41 of these achieved a 3 month follow-up . Twenty-one patients received MMA embolization. At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015). Two participants presented a CSDH recurrence (one in each group). One patient died (ST group). No MMA embolization-related adverse events were reported. CONCLUSION The addition of MMA embolization to surgery led to an increase in CSDH resorption at 3 months. One recurrence of CSDH was reported in each group, and there were no treatment-related complications.",2020,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","['46 patients', 'From April 2018 to October 2018, participants with CSDH requiring surgery', 'symptomatic patients', 'symptomatic chronic subdural hematoma']","['MMA embolization', 'surgical treatment alone (ST group) or surgery and adjuvant MMA embolization (ST+MMAE group', 'Middle meningeal artery embolization', 'Middle meningeal artery (MMA) embolization']","['MMA embolization-related adverse events', 'CSDH recurrence', 'recurrence of CSDH', 'clinical recurrence of CSDH and safety measures', 'CSDH resorption', 'hematoma volume resorption (HVR', 'HVR from postsurgical level', 'HVR measured on the 3\u2009month CT scan']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0226147', 'cui_str': 'Structure of middle meningeal artery'}]","[{'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]",46.0,0.100507,"At 3 months, the HVR from postsurgical level was higher in the ST+MMAE group (mean difference 17.5 mL, 95% CI 3.87 to 31.16 mL; p=0.015).","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France s-ng@chu-montpellier.fr.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Derraz', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Boetto', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Dargazanli', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Poulen', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gascou', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Pierre-Henri', 'Initials': 'PH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': 'Department of Statistics, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lonjon', 'Affiliation': 'Department of Neurosurgery, Montpellier University Medical Center, Montpellier, Occitanie, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Neuroradiology, Montpellier University Medical Center, Montpellier, Occitanie, France.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015421'] 1307,30260251,A dose-response relationship study of hypertonic saline on brain relaxation during supratentorial brain tumour craniotomy.,"Background: A prospective, randomized, double-blind study was designed to assess differences in brain relaxation between 2 doses of 3% HS during elective supratentorial brain tumour surgery. Methods: 60 patients undergoing supratentorial craniotomy for tumour resection were enrolled to receive either 3 mL/kg (group L) or 5 mL/kg (group H) of 3% HS administered at skin incision. Brain relaxation was assessed after dura opening on a scale ranging 1-4 (1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain). Hemodynamic variables and laboratory values (blood gases, osmolarity, haematocrit, and lactate) were collected before HS infusion and 30, 120 and 360 min after it. Presence of midline shift, postoperative complications, PCU and hospital stay, and mortality after 30 days were also recorded. Results: There was no difference in brain relaxation, with 2.0 (1.0-3.0) and 2.0 (1.0-2.3) ( P  = 0.535) for patients in groups L and H, respectively. If adjusted for the presence of midline shift, 50% of patients had adequate brain relaxation scores (grades 1 and 2) in group L and 61% in group H (OR 0.64, CI = 0.16-2.49, P  = 0.515). No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed. Conclusion: 3 mL/kg of 3% HS result in similar brain relaxation scores as 5 mL/kg in patients undergoing craniotomy for supratentorial brain tumour. This study reveals that both high and low doses of 3% HS may be less effective on intraoperative brain relaxation in patients with midline shift.",2018,"No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed. ","['patients with midline shift', 'supratentorial brain tumour craniotomy', '60 patients undergoing supratentorial craniotomy for tumour resection']","['3\u2009mL/kg (group L) or 5\u2009mL/kg (group H) of 3% HS administered at skin incision', 'hypertonic saline', 'HS']","['Hemodynamic variables and laboratory values (blood gases, osmolarity, haematocrit, and lactate', 'intraoperative brain relaxation', 'brain relaxation scores', 'Brain relaxation', 'perioperative outcome, mortality and length of PCU and hospital stay', 'midline shift, postoperative complications, PCU and hospital stay, and mortality', 'brain relaxation', 'adequate brain relaxation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1522407', 'cui_str': 'Supratentorial brain structure (body structure)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0441846', 'cui_str': 'Group L (qualifier value)'}, {'cui': 'C0441842', 'cui_str': 'Group H (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",60.0,0.337276,"No significant differences in perioperative outcome, mortality and length of PCU and hospital stay were observed. ","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Hernández-Palazón', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fuentes-García', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Doménech-Asensi', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Burguillos-López', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'García-Ferreira', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Falcón-Araña', 'Affiliation': 'Department of Anaesthesia, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Piqueras-Pérez', 'Affiliation': 'Department of Neurosurgery, Hospital Universitario ""Virgen de la Arrixaca"", Murcia, Spain.'}]",British journal of neurosurgery,['10.1080/02688697.2018.1508640'] 1308,30238430,Change of skeletal muscle mass in patients with pheochromocytoma.,"The effects of catecholamine excess due to pheochromocytoma on body composition, including skeletal muscle mass, are unknown. Here, we investigated the effects of catecholamine metabolites on body composition in subjects with pheochromocytoma. After body compositions using bioelectrical impedance analysis, urinary metanephrine (UM), and urinary normetanephrine (UNM) were measured in 16 patients with pheochromocytoma and 224 patients with nonfunctioning adrenal incidentaloma (NFAI), we compared skeletal muscle mass and fat mass (FM) between the two groups. After adjustments for confounders, UM (β = - 0.171, P = 0.006) and UNM (β = - 0.249, P < 0.001) levels were correlated inversely with skeletal muscle mass index (SMI), but not FM or percentage FM (pFM), in all subjects. Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI. Conversely, FM and pFM were not statistically different between the two groups. The odds ratio for low skeletal muscle mass in the presence of pheochromocytoma was 10.33 (95% confidence interval, 2.65-40.22). Our results indicate that patients with pheochromocytoma have a reduced skeletal muscle mass and suggest that catecholamine excess has adverse effects on skeletal muscle metabolism.",2019,Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI.,"['16 patients with pheochromocytoma and 224 patients with nonfunctioning adrenal incidentaloma (NFAI', 'subjects with pheochromocytoma', 'patients with pheochromocytoma']","['catecholamine metabolites', 'catecholamine']","['SMI', 'body composition', 'lower ASM', 'FM and pFM', 'bioelectrical impedance analysis, urinary metanephrine (UM), and urinary normetanephrine (UNM', 'skeletal muscle mass', 'skeletal muscle mass index (SMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031511', 'cui_str': 'Pheochromocytoma'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C2609247', 'cui_str': 'Adrenal incidentaloma'}]","[{'cui': 'C1291743', 'cui_str': 'Catecholamine metabolite'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0025562', 'cui_str': 'Metadrenaline'}, {'cui': 'C0028385', 'cui_str': '3-Methoxynoradrenaline'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0682476,Patients with pheochromocytoma had lower ASM by 7.7% (P = 0.022) and SMI by 6.6% (P = 0.001) than patients with NFAI.,"[{'ForeName': 'Seung Hun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kwak', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Seong Hee', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Hyeonmok', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Yoon Young', 'Initials': 'YY', 'LastName': 'Cho', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Gyeongsang National University School of Medicine, Jinju, South Korea.'}, {'ForeName': 'Sunghwan', 'Initials': 'S', 'LastName': 'Suh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Dong-A University Medical Center, Dong-A, University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Kee-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Koh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea. jaehyeon@skku.edu.'}, {'ForeName': 'Beom-Jun', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea. umkbj0825@amc.seoul.kr.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-018-0959-3'] 1309,30297988,"The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis.","Background: There is paucity in the literature regarding the role of the interoceptive pathway through the insular cortex (IC), as well as heart rate variability (HRV) in relation to Osteopathic Manipulative Therapy (OMT) and deep-touch. Aims: The present study investigated whether both OMT treatment and deep-touch (a newly hypothesized treatment option) was effective at altering the interoceptive pathway and HRV, whilst OMT was only expected to be effective for increasing Range of Motion (ROM). Methods: Thirty-five healthy volunteers were randomly allocated into three conditions in a repeated measures crossover design; a control (laying supine on a plinth); deep-touch (head cradling); and an osteopathic mobilization therapeutic technique on the temporomandibular joint (TMJ). Interoceptive accuracy (IAc), HRV, as well as range of motion (ROM) for the TMJ area as well as the cervical spine (Csp) right and left measures were taken pre and post each condition setting. Results: Significant condition effects emerged from the deep-touch and mobilization interventions for IAc where increases were identified through planned comparisons. For the HRV measure (RMSSD), a significant effect emerged in the deep-touch condition (increase) but not in the mobilization or control conditions. ROM did not increase for any condition. IAc correlated with post-ROM outcomes in many cases and HRV moderated some of these relations. Conclusion: These results are discussed in the context of clinical practice, where cranial deep-touch maybe an effective treatment and modulator of the parasympathetic nervous systems, as well as the interoceptive system.",2018,"Interoceptive accuracy (IAc), HRV, as well as range of motion (ROM) for the TMJ area as well as the cervical spine (Csp",['Methods: Thirty-five healthy volunteers'],"['OMT', 'Therapeutic Touch and Deep Touch Pressure', 'control (laying supine on a plinth); deep-touch (head cradling); and an osteopathic mobilization therapeutic technique on the temporomandibular joint (TMJ']","['cervical spine (Csp', 'deep-touch and mobilization interventions for IAc', 'ROM', 'Interoceptive accuracy (IAc), HRV, as well as range of motion (ROM', 'Range of Motion, Interoceptive Accuracy and Heart Rate Variability']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",35.0,0.0270611,"Interoceptive accuracy (IAc), HRV, as well as range of motion (ROM) for the TMJ area as well as the cervical spine (Csp","[{'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Cutis', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Johnston', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}]",Frontiers in integrative neuroscience,['10.3389/fnint.2018.00041'] 1310,30188800,SIMPLE INTERMITTENT RESISTANCE ACTIVITY MITIGATES THE DETRIMENTAL EFFECT OF PROLONGED UNBROKEN SITTING ON ARTERIAL FUNCTION IN OVERWEIGHT AND OBESE ADULTS.,"Prolonged sitting contributes to cardiovascular disease (CVD) risk. The underlying mechanisms are unknown, but may include changes in arterial function and vasoactive mediators. We examined the effects of prolonged unbroken sitting, relative to regular active interruptions to sitting time, on arterial function in adults at increased CVD risk. In a randomized crossover trial, 19 sedentary overweight/obese adults (mean±SD 57±12 yrs), completed two laboratory-based conditions: five hours uninterrupted sitting (SIT) and; five hours sitting interrupted every 30 minutes by three minutes of simple resistance activities (SRA). Femoral artery function (flow mediated dilation; FMD), blood flow and shear rate were measured at zero hour, 30 minutes, one, two and five hours. Brachial FMD was assessed at zero and five hours. Plasma was collected hourly for measurement of endothelin-1 (ET-1), nitrates/nitrites, vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1). There was a significant decline in femoral artery FMD, averaged over five hours in the SIT condition, relative to SRA (p<0.001). Plasma ET-1 total AUC over five hours increased in the SIT condition compared to SRA (p=0.006). There was no significant difference between conditions in femoral or brachial shear rate, brachial FMD, nitrates/nitrites, VCAM-1 or ICAM-1 (p>0.05 for all). Five hours of prolonged sitting, relative to regular interruptions to sitting time, impaired femoral artery vasodilator function and increased circulating ET-1 in overweight/obese adults. There is the need to build on this evidence beyond acute observations to better understand the potential longer-term vascular-related consequences of prolonged sitting.",2018,"There was no significant difference between conditions in femoral or brachial shear rate, brachial FMD, nitrates/nitrites, VCAM-1 or ICAM-1 (p>0.05 for all).","['overweight/obese adults', '19 sedentary overweight/obese adults (mean±SD 57±12 yrs', 'adults at increased CVD risk']",['laboratory-based conditions: five hours uninterrupted sitting (SIT) and; five hours sitting interrupted every 30 minutes by three minutes of simple resistance activities (SRA'],"['femoral artery vasodilator function', 'endothelin-1 (ET-1), nitrates/nitrites, vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1', 'femoral artery FMD', 'Plasma ET-1 total AUC', 'femoral or brachial shear rate, brachial FMD, nitrates/nitrites, VCAM-1 or ICAM-1', 'Femoral artery function (flow mediated dilation; FMD), blood flow and shear rate', 'Brachial FMD']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0585318', 'cui_str': 'Every thirty minutes (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}]","[{'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",19.0,0.0450243,"There was no significant difference between conditions in femoral or brachial shear rate, brachial FMD, nitrates/nitrites, VCAM-1 or ICAM-1 (p>0.05 for all).","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Climie', 'Affiliation': '99 Commercial Rd, Baker Heart and Diabetes Institute, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wheeler', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grace', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'Neale', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Kingwell', 'Affiliation': 'Baker Heart and Diabetes Institute.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00544.2018'] 1311,31862739,"A double masked randomised 4-week, placebo-controlled study in the USA, Thailand and Taiwan to compare the efficacy of oral valganciclovir and topical 2% ganciclovir in the treatment of cytomegalovirus anterior uveitis: study protocol.","INTRODUCTION Cytomegalovirus (CMV) anterior uveitis is a recognised cause of anterior uveitis in immunocompetent patients and is preventable cause of vision loss. Ocular sequelae include corneal endothelial damage which can cause corneal oedema and failure, as well as glaucoma. Recurrences of inflammation are common and therefore patients are often exposed to long-term therapy. Oral therapy is available in the form of valganciclovir, although with the caveat of systemic side effects such as bone marrow suppression and renal failure necessitating regular interval laboratory monitoring. Recent reports have demonstrated that topical 2% ganciclovir solution may offer promising treatment outcomes in patients with CMV anterior uveitis with superior safety, cost-effectiveness and convenience profiles. An investigation into the relative equipoise of these therapies is warranted for these reasons. METHODS AND ANALYSIS The Systemic and Topical Control of Cytomegalovirus Anterior uveitis: Treatment Outcomes (STACCATO) trial is designed as a multicentre, block randomised by site, double-masked, placebo-controlled trial comparing the efficacy of oral valganciclovir, 2% topical ganciclovir and placebo in treating PCR-proven CMV anterior uveitis. Participant clinical evaluation will occur at three study time points by a masked study ophthalmologist over a 28-day period to assess resolution of ocular inflammation (secondary outcome). A control group will provide additional information about the possible impact that the infected host's immune response may play in controlling local viral replication. The primary analysis is an analysis of covariance (three arms) correcting for baseline to compare quantitative CMV viral load in the anterior chamber (AC) aqueous fluid before and 7 days after treatment. ETHICS AND DISSEMINATION The University of California San Francisco Committee on Human Research and the Khon Kaen University Institutional Review Board have given ethical approval. The results of this trial will be presented at local and international meetings and submitted for peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER NCT03576898.",2019,"INTRODUCTION Cytomegalovirus (CMV) anterior uveitis is a recognised cause of anterior uveitis in immunocompetent patients and is preventable cause of vision loss.","['Cytomegalovirus Anterior uveitis', 'treating PCR-proven CMV anterior uveitis', 'cytomegalovirus anterior uveitis', 'patients with CMV anterior uveitis']","['placebo', 'oral valganciclovir and topical 2% ganciclovir', 'oral valganciclovir, 2% topical ganciclovir and placebo', 'ganciclovir solution']",['quantitative CMV viral load in the anterior chamber (AC) aqueous fluid'],"[{'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0042165', 'cui_str': 'Anterior uveitis (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}]",,0.379374,"INTRODUCTION Cytomegalovirus (CMV) anterior uveitis is a recognised cause of anterior uveitis in immunocompetent patients and is preventable cause of vision loss.","[{'ForeName': 'Jaskirat S', 'Initials': 'JS', 'LastName': 'Takhar', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ashlin S', 'Initials': 'AS', 'LastName': 'Joye', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thanapong', 'Initials': 'T', 'LastName': 'Somkijrungroj', 'Affiliation': 'Ophthalmology, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Wipada', 'Initials': 'W', 'LastName': 'Laovirojjanakul', 'Affiliation': 'Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chang-Ping', 'Initials': 'CP', 'LastName': 'Lin', 'Affiliation': 'Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Gebreegziabher', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Gerami D', 'Initials': 'GD', 'LastName': 'Seitzman', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thuy A', 'Initials': 'TA', 'LastName': 'Doan', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gonzales', 'Affiliation': 'Proctor Foundation, University of California San Francisco, San Francisco, California, USA john.gonzales@ucsf.edu.'}]",BMJ open,['10.1136/bmjopen-2019-033175'] 1312,30132686,Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder.,"Objective: A recent double-blind randomized placebo-controlled study demonstrated 3-month efficacy and safety of a novel pediatric-appropriate prolonged-release melatonin (PedPRM) for insomnia in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity. Long-term efficacy and safety of PedPRM treatment was studied. Methods: A prospective, open-label efficacy and safety follow-up of nightly 2, 5, or 10 mg PedPRM in subjects who completed the 13-week double-blind trial (51 PedPRM; 44 placebo). Measures included caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index). Results: Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received PedPRM (2/5 mg) according to the double-blind phase dose, for 39 weeks with optional dose adjustment (2, 5, or 10 mg/day) after the first 13 weeks. After 52 weeks of continuous treatment (PedPRM-randomized group) subjects slept (mean [SE]) 62.08 (21.5) minutes longer ( p  = 0.007); fell asleep 48.6 (10.2) minutes faster ( p  < 0.001); had 89.1 (25.5) minutes longer uninterrupted sleep episodes ( p  = 0.001); 0.41 (0.12) less nightly awakenings (>50% decrease; p  = 0.001); and better sleep quality ( p  < 0.001) compared with baseline. The placebo-randomized group also improved with PedPRM. Altogether, by the end of 39-week follow-up, regardless of randomization assignment, 55/72 (76%) of completers achieved overall improvement of ≥1 hour in total sleep time (TST), sleep latency or both, over baseline, with no evidence of decreased efficacy. In parallel, CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns ( p  < 0.001 for both), PSQI global ( p  < 0.001), and WHO-5 ( p  = 0.001) improved in statistically significant and clinically relevant manner ( n  = 72) compared with baseline. PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients). Conclusion: PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.",2018,"PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients). ","['Children with Autism Spectrum Disorder', 'children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity', 'subjects who completed the 13-week double-blind trial (51 PedPRM; 44', 'Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received']","['Pediatric Prolonged-Release Melatonin', 'PedPRM', 'placebo', 'novel pediatric-appropriate prolonged-release melatonin (PedPRM']","[""CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns"", ""caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index"", 'WHO-5', 'nightly awakenings', 'uninterrupted sleep episodes', 'overall improvement of ≥1 hour in total sleep time (TST), sleep latency', 'PSQI global', 'efficacy', 'sleep quality', ""caregivers' quality of life""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0034380'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",95.0,0.55034,"PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients). ","[{'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Academy, Yulius Mental Health Organization, Barendrecht, The Netherlands.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Schroder', 'Affiliation': 'Strasbourg University Hospital Department of Child and Adolescent Psychiatry, Strasbourg, France.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Sleep Division, Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Kennedy Krieger Institute/Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Breddy', 'Affiliation': 'Pharmastat Consulting Ltd., Canterbury, United Kingdom.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Nir', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Shahmoon', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Zisapel', 'Affiliation': 'Neurim Pharmaceuticals Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gringras', 'Affiliation': ""Children's Sleep Medicine, Evelina London Children's Hospital, Guy's and St. Thomas', London, United Kingdom.""}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0020'] 1313,30307692,Effectiveness of Two Different Methods for Pain Reduction During Insulin Injection in Children With Type 1 Diabetes: Buzzy and ShotBlocker.,"BACKGROUND Repeated injections may prevent children from performing insulin administration (skip dosing) and may cause anxiety. AIMS To compare the effect of ShotBlocker and the combination of vibration and cold application (Buzzy) in reducing pain during insulin administration in children. METHODS This research was designed as a randomized controlled experimental study. The study sample consisted of 60 children aged between 6 and 12 years who were diagnosed as having type 1 diabetes and received insulin from the Child Endocrinology Department of the medical faculty in Eskisehir Osmangazi University between May 2015 and June 2017. The children were randomized into the Buzzy (n = 20), ShotBlocker (n = 20), and control (n = 20) groups. Three instruments were used to obtain the research data: Interview and Observation Form, Children's Anxiety and Pain Scale (CAPS), and Faces Pain Scale-Revised (FPS-R). RESULTS The mean age of the children was 9.43 ± 2.18 years (range 6-12 years). There were no significant differences among preprocedural anxiety levels of the study groups in terms of self-, parent-, and observer-reported levels (p = .935, p = .374, and p = .680, respectively). Children in the control group had higher levels of pain than children in the Buzzy and ShotBlocker groups (p = .008, p = .007, and p > .001, respectively). There was a significant difference between the groups with procedural anxiety levels reported by the family and observer (p = .006 and p = .002, respectively), favoring the intervention groups. LINKING EVIDENCE TO ACTION Nurses should be aware of pain during insulin injection and use methods for pain relief accordingly. ShotBlocker is recommended as a helpful option in cases where a pain control method is required.",2018,"There were no significant differences among preprocedural anxiety levels of the study groups in terms of self-, parent-, and observer-reported levels (p = .935, p = .374, and p = .680, respectively).","['children', 'Children With Type 1 Diabetes', 'The mean age of the children was 9.43\xa0±\xa02.18\xa0years ', '60 children aged between 6 and 12\xa0years who were diagnosed as having type 1 diabetes and received insulin from the Child Endocrinology Department of the medical faculty in Eskisehir Osmangazi University between May 2015 and June 2017']","['ShotBlocker and the combination of vibration and cold application (Buzzy', 'Insulin Injection', 'Buzzy']","['pain', 'Pain Reduction', 'higher levels of pain', 'procedural anxiety levels', ""Children's Anxiety and Pain Scale (CAPS), and Faces Pain Scale-Revised (FPS-R"", 'self-, parent-, and observer-reported levels', 'preprocedural anxiety levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0587463', 'cui_str': 'Endocrinology department (environment)'}, {'cui': 'C0015537', 'cui_str': 'Faculty, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",60.0,0.067838,"There were no significant differences among preprocedural anxiety levels of the study groups in terms of self-, parent-, and observer-reported levels (p = .935, p = .374, and p = .680, respectively).","[{'ForeName': 'Nejla', 'Initials': 'N', 'LastName': 'Canbulat Sahiner', 'Affiliation': 'Pediatric Nursing Department, Health Science Faculty, Karamanoglu Mehmetbey University, Karaman, Turkey.'}, {'ForeName': 'Ayse Sonay', 'Initials': 'AS', 'LastName': 'Turkmen', 'Affiliation': 'Pediatric Nursing Department, Health Science Faculty, Karamanoglu Mehmetbey University, Karaman, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Acikgoz', 'Affiliation': 'Nursing Department, Health Science Faculty, Eskisehir Osmangazi University, Eskisehir, Turkey.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Simsek', 'Affiliation': 'Child Endocrinology Department, Medical Faculty, Eskisehir Osmangazi University, Eskisehir, Turkey; Birgul Kirel.'}, {'ForeName': 'Birgul', 'Initials': 'B', 'LastName': 'Kirel', 'Affiliation': 'Child Endocrinology Department, Medical Faculty, Eskisehir Osmangazi University, Eskisehir, Turkey; Birgul Kirel.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12325'] 1314,30156134,Patients' self-report on post-retained restoration is more valuable than expected! Explorative analysis of an 11-year follow-up.,"Objective: Assessment of long-term clinical data regarding post-endodontic restorations is essential for the evaluation of different post-and-core concepts. The aim of the present study was to assess the diagnostic accuracy of patient self-reporting on post-endodontic restorations after 11 years of clinical service. Materials and methods: Twenty-nine patients (61 ± 15 years old) with endodontic glass-fibre and titanium post-endodontic restorations were examined within the 11-year follow-up of a randomized controlled trial. Restorations were assessed by self-reports during a telephone interview (one item), the completion of a four-item questionnaire and clinical and radiographic examination. A gold standard for restoration in situ or 'failure' was defined by clinical and radiographic examination. Diagnostic accuracy of patients' self-reports was evaluated by calculating the sensitivity, specificity, and positive (PPV) and negative predictive values (NPV). Results: After a mean observation time of 137 months (min/max: 125/154 months), 25 (86.2%) restorations were in situ and 4 (13.8%) failures were detected. Self-report during a telephone interview and the four-item questionnaire correctly identified all in situ restorations (specificity = both 100%, NPV = 92.6%/96.2%). Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%). Conclusions: When the clinical examination is not feasible, patients' self-report shows valuable diagnostic potential in the identification of the post-endodontic failure.",2019,"Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%). ","['Twenty-nine patients (61\u2009±\u200915 years old) with endodontic glass-fibre and titanium post-endodontic restorations', 'patient self-reporting on post-endodontic restorations after 11 years of clinical service']",[],"['sensitivity, specificity, and positive (PPV) and negative predictive values (NPV']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",[],"[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0340304,"Self-report during a telephone interview identified two out of four failures (sensitivity = 50%, PPV = 100%), and self-report on the four-item questionnaire identified three out of four failures (sensitivity = 75%, PPV = 100%). ","[{'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'von Stein-Lausnitz', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Matthias J', 'Initials': 'MJ', 'LastName': 'Roggendorf', 'Affiliation': 'Department of Operative Dentistry and Endodontics, Medical Center for Dentistry, University Medical Center Giessen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Sterzenbach', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naumann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Berlin, Germany.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2018.1497804'] 1315,31647564,Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.,"INTRODUCTION Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone. METHODS We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day. RESULTS Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction. CONCLUSIONS Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit. IMPLICATIONS A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.",2020,SGR did not add significantly to helping women quit or reduce.,"['pregnant women quit smoking', 'Pregnant Smokers', '314 pregnant women from 14 prenatal clinics']","['Texting Program', 'SMS text-delivered scheduled gradual reduction (SGR) program plus support texts']","['7-day point prevalence abstinence at late pregnancy', 'reduction in cigarettes per day', 'quit rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",314.0,0.068689,SGR did not add significantly to helping women quit or reduce.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bejarano Hernandez', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Subudhi', 'Affiliation': 'Doctor of Medicine Program, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, DUMC 3083, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz174'] 1316,31641729,Red Blood Cell Omega-3 Fatty Acid Composition and Psychotropic Drug Use in Older Adults: Results from the MAPT Study.,"Low docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) concentration has been associated with the development of some psychiatric disorders. OBJECTIVES to assess the association between red blood cell (RBC) DHA-EPA concentration and psychotropic drug use in older adults and between the 1-year change in RBC DHA-EPA and psychotropic drug use at 12 months. DESIGN secondary analysis of multicenter, randomized controlled trial testing multidomain intervention and/or n-3 PUFA supplement on cognitive function (MAPT study). SETTING France, 2008-2014. PARTICIPANTS 1680 participants ≥70 years, community-dwelling were included. MEASUREMENTS Psychotropic drug use was self-reported during medical interviews and assessments. RBC n-3 PUFA concentration was defined by % of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) among total fatty acids. Logistic regressions models controlling for age, sex, education, depression risk and intervention group were used. RESULTS 1594 participants had baseline DHA-EPA concentration available (mean age=75.5±4.5 years, 65% females). At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA. Participants who experienced an increase in DHA-EPA from baseline were less likely to use a psychotropic drug at 12 months than participants with no change or a decrease (aOR=0.72, 95%CI=[0.55-0.96]). CONCLUSION Low RBC DHA-EPA concentration was independently associated with psychotropic drug use. Future studies are needed to assess whether low RBC DHA-EPA is a risk marker for psychotropic drug use in older adults and to better understand underlying pathophysiological mechanisms. Registration number: ClinicalTrials.gov database (NCT00672685).",2019,"At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA.","['1594 participants had baseline DHA-EPA concentration available (mean age=75.5±4.5 years, 65% females', '1680 participants ≥70 years, community-dwelling were included', 'older adults', 'Older Adults', 'France, 2008-2014']","['multidomain intervention and/or n-3 PUFA supplement', 'Low docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA']","['Low RBC DHA-EPA concentration', 'DHA-EPA', 'prevalence of use of overall psychotropic drugs', 'RBC n-3 PUFA concentration', 'anxiolytic/hypnotic drugs', 'red blood cell (RBC) DHA-EPA concentration']","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517596', 'cui_str': '1680'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033978', 'cui_str': 'Psychoactive Drugs'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0040616', 'cui_str': 'Anti-Anxiety Drugs'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}]",1594.0,0.31734,"At baseline, participants with DHA-EPA ≤4.82% (lowest quartile) reported higher prevalence of use of overall psychotropic drugs (34.0% vs 24.4%; aOR=1.33, 95%CI=[1.03-1.72]), anxiolytic/hypnotic drugs (25.0% vs 18.2%; aOR=1.42, 95%CI=[1.07-1.89]), and antidepressants (18.3% vs 13.5%; aOR=1.25, 95%CI=[0.93-1.72]) than participants with higher DHA-EPA.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gallini', 'Affiliation': 'Adeline Gallini, PharmD, PhD, Epidemiology Department 37 allées Jules Guesde, 31062 Toulouse Cedex, Tel : +33 5 61 14 56 81, Fax : + 33 5 62 26 42 40, Email : adeline.gallini@univ-tlse3.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yrondi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Poncet', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-019-1252-4'] 1317,30060707,Efficacy of EGF and Gelatin Sponge for Traumatic Tympanic Membrane Perforations: A Randomized Controlled Study.,"OBJECTIVE To compare the outcomes of epidermal growth factor (EGF) and gelatin sponge patch treatments for traumatic tympanic membrane perforations. STUDY DESIGN Prospective, randomized, controlled. SETTING University-affiliated teaching hospital. SUBJECTS AND METHODS In total, 141 perforations encompassing >50% of the eardrum were randomly divided into 3 groups: EGF (n = 47), gelatin sponge patch (n = 47), and observation (n = 47). The edges of the perforations were not approximated. The closure rate, mean closure time, and infection rate were evaluated at 6 months and the related factors analyzed. RESULTS A total of 135 perforations were analyzed. At 6 months, the closure rates were 97.8%, 86.7%, and 82.2% in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P = .054). The mean ± SD closure time was 11.12 ± 4.60, 13.67 ± 5.37, and 25.65 ± 13.32 days in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P < .001). In addition, the presence of infection was not significantly associated with rate of closure in any group. CONCLUSIONS As compared with spontaneous healing, daily application of EGF and gelatin sponge patching reduced the closure time of traumatic tympanic membrane perforations. EGF treatment had a higher closure rate and shorter closure time but resulted in otorrhea. By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication. Thus, the appropriate treatment should be selected according to patient need.",2018,"By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication.","['Setting University-affiliated teaching hospital', 'Traumatic Tympanic Membrane Perforations', 'traumatic tympanic membrane perforations']","['EGF', 'epidermal growth factor (EGF) and gelatin sponge patch treatments', 'gelatin sponge patch', 'gelatin sponge patches', 'EGF and gelatin sponge patching', 'EGF and Gelatin Sponge']","['rate of closure', 'closure rate or cause otorrhea', 'mean ± SD closure time', 'closure time of traumatic tympanic membrane perforations', 'closure rate, mean closure time, and infection rate', 'closure rates', 'closure rate and shorter closure time']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0585355', 'cui_str': 'Traumatic tympanic membrane perforation (disorder)'}]","[{'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0155540', 'cui_str': 'Otorrhea (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0585355', 'cui_str': 'Traumatic tympanic membrane perforation (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",135.0,0.0456551,"By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication.","[{'ForeName': 'Zheng Cai', 'Initials': 'ZC', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Affiliated Yiwu Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department Clinical Class No. 11, Clinical Medicine, Xinxiang Medical University, Henan, China.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599818792019'] 1318,30021408,Pregabalin and dexmedetomidine conscious sedation for flexible bronchoscopy: a randomized double-blind controlled study.,"BACKGROUND Conscious sedation is usually required during flexible bronchoscopy. Sedation should be achieved without respiratory depression or loss of consciousness. The present study was designed to evaluate the effect of pregabalin premedication on reducing the amount of sedatives and to show its advantages for patients undergoing flexible bronchoscopy with dexmedetomidine. METHODS Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two groups of 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients were sedated with dexmedetomidine infusion to achieve optimum sedation. During the procedure peripheral oxygen saturation, respiratory rate, hemodynamics, Ramsay sedation Score, cough score, and total amount of dexmedetomidine used were recoded. After the procedure patients' and pulmonologists' satisfaction were compared. RESULTS The total amount of dexmedetomidine used in PG was less compared to C group (P=0.01). Sedation score was higher in PG group at the time of theatre admission (P<0.001). Cough score was higher, but insignificant in group C (P=0.08). Patients' and pulmonologists' satisfaction scores were higher in group PG (P=0.007 and 0.001 respectively). The heart rate and mean arterial pressure were lower in the C group (P=0.02 and 0.03 respectively). Postoperative care unit stay was less in group PG with less analgesic requirements. CONCLUSIONS Conscious sedation facilitates flexible bronchoscopy. Premedication with pregabalin can reduce the amount of sedatives. Dexmedetomidine with pregabalin premedication has many advantages over dexmedetomidine alone.",2019,The heart rate and mean arterial pressure were lower in the C group (P=0.02 and 0.03 respectively).,"['patients undergoing flexible bronchoscopy with dexmedetomidine', 'Seventy patients undergoing elective flexible bronchoscopy', 'flexible bronchoscopy']","['pregabalin premedication', 'placebo', 'Dexmedetomidine with pregabalin premedication', 'Pregabalin', 'pregabalin', 'dexmedetomidine', 'dexmedetomidine conscious sedation']","['Sedation score', 'Cough score', 'heart rate and mean arterial pressure', ""pulmonologists' satisfaction scores"", 'amount of sedatives', 'procedure peripheral oxygen saturation, respiratory rate, hemodynamics, Ramsay sedation Score, cough score, and total amount of dexmedetomidine', ""pulmonologists' satisfaction"", 'Postoperative care unit stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]",70.0,0.0867795,The heart rate and mean arterial pressure were lower in the C group (P=0.02 and 0.03 respectively).,"[{'ForeName': 'Ezzeldin', 'Initials': 'E', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt - ezzeldin7@yahoo.com.'}, {'ForeName': 'Wesameldin', 'Initials': 'W', 'LastName': 'Sultan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Saffa', 'Initials': 'S', 'LastName': 'Helal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Abo-Elwafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.18.12685-X'] 1319,31647468,Antismoking Advertisements and Price Promotions and Their Association With the Urge to Smoke and Purchases in a Virtual Convenience Store: Randomized Experiment.,"BACKGROUND Point of sale (POS) advertising is associated with smoking initiation, current smoking, and relapse among former smokers. Price promotion bans and antismoking advertisements (ads) are 2 possible interventions for combating POS advertising. OBJECTIVE The purpose of this analysis was to determine the influence of antismoking ads and promotions on urges to smoke and tobacco purchases. METHODS This analysis examined exposure to graphic (graphic images depicting physical consequences of tobacco use) and supportive (pictures of and supportive messages from former smokers) antismoking ads and promotions in a virtual convenience store as predictors of urge to smoke and buying tobacco products among 1200 current cigarette smokers and 800 recent quitters recruited via a Web-based panel (analytical n=1970). We constructed linear regression models for urge to smoke and logistic regression models for the odds of purchasing tobacco products, stratified by smoking status. RESULTS The only significant finding was a significant negative relationship between exposure to supportive antismoking ads and urge to smoke among current smokers (beta coefficient=-5.04, 95% CI -9.85 to -0.22; P=.04). There was no significant relationship between graphic antismoking ads and urge to smoke among current smokers (coefficient=-3.77, 95% CI -8.56 to 1.02; P=.12). Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20). There were no significant differences in urge to smoke by exposure to promotions for current smokers (coefficient=-1.06, 95% CI -4.53 to 2.41; P=.55) or recent quitters (coefficient=1.76, 95% CI -2.07 to 5.59; P=.37). There were also no differences in tobacco purchases by exposure to graphic (current smokers: coefficient=0.93, 95% CI 0.67 to 1.29; P=.66 and recent quitters: coefficient=0.73, 95% CI 0.44 to 1.19; P=.20) or supportive (current smokers: coefficient=1.05, 95% CI 0.75 to 1.46; P=.78 and recent quitters: coefficient=0.73, 95% CI 0.45 to 1.18; P=.20) antismoking ads or price promotions (current smokers: coefficient=1.09, 95% CI 0.86 to 1.38; P=.49 and recent quitters: coefficient=0.90, 95% CI 0.62 to 1.31; P=.60). CONCLUSIONS The results of this analysis support future research on the ability of supportive antismoking ads to reduce urges to smoke among current cigarette smokers. Research on urges to smoke has important tobacco control implications, given the relationship between urge to smoke and smoking cigarettes, time to next smoke, and amount smoked.",2019,"Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20).","['1200 current cigarette smokers and 800 recent quitters recruited via a Web-based panel (analytical n=1970', 'P=.78 and recent quitters']",[],"['tobacco purchases', 'graphic antismoking ads and urge to smoke', 'antismoking ads or price promotions', 'urge to smoke']","[{'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],"[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",1200.0,0.0474676,"Neither relationship was significant for recent quitters (graphic: coefficient=-3.42, 95% CI -8.65 to 1.81; P=.15 or supportive: coefficient=-3.82, 95% CI -8.99 to 1.36; P=.20).","[{'ForeName': 'Lauren McCarl', 'Initials': 'LM', 'LastName': 'Dutra', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Berkeley, CA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bradfield', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Ireland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Feld', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Annice', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, NC, United States.'}]",Journal of medical Internet research,['10.2196/14143'] 1320,29985087,"Improbable, but plausible, research study: a randomised controlled trial of premature cord clamping vs. neonatal venesection to achieve routine prophylactic neonatal red cell reduction.",,2018,,[],['premature cord clamping vs. neonatal venesection'],[],[],"[{'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]",[],,0.0398055,,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weeks', 'Affiliation': ""1 Sanyu Research Unit, Department of Women's and Children's Health, Liverpool Women's Hospital, University of Liverpool, Liverpool L8 7SS, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bewley', 'Affiliation': ""2 Department of Women and Children's Health, Faculty of Life Sciences and Medicine, Kings College London, St Thomas' Hospital, London SE1 7EH, UK.""}]",Journal of the Royal Society of Medicine,['10.1177/0141076818781406'] 1321,31648705,Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia.,"BACKGROUND Evolocumab and other anti-PCSK9 antibodies reduced adverse cardiovascular outcomes in clinical trials of high-risk patients over <3 years median treatment duration. OBJECTIVES The OSLER-1 trial (Open Label Study of Long Term Evaluation Against LDL-C Trial) evaluated longer-term effects of evolocumab during open-label hypercholesterolemia treatment for up to 5 years. METHODS Patients randomized to standard of care (SOC) or evolocumab 420 mg monthly (evolocumab + SOC) for year 1. After year 1, patients could enter the all-evolocumab period and receive evolocumab + SOC for an additional 4 years. The authors analyzed the persistence of lipid effects and exposure-dependent safety focusing on yearly rates of adverse events (AEs) and anti-drug antibodies over 4.951 patient-years of observation. RESULTS A total of 1,255 patients (safety analysis population) randomized into the year 1 SOC-controlled period and received ≥1 evolocumab dose (mean ± SD age 57 ± 12 years; 53% female). A total of 1,151 patients (efficacy analysis population) progressed to the all-evolocumab period (year 2 and beyond). Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization. Mean baseline LDL-C decreased from 140 to 61 mg/dl on treatment. Yearly serious AE rates during evolocumab + SOC ranged from 6.9% to 7.9%, comparable to the 6.8% rate in SOC patients during year 1. Evolocumab discontinuation due to AEs occurred in 5.7% of patients. Two SOC and 2 evolocumab + SOC patients developed new, transient, binding anti-drug antibodies; no neutralizing antibodies were observed. CONCLUSIONS The OSLER-1 trial demonstrated consistently excellent LDL-C-lowering efficacy, tolerance, and safety of evolocumab, with no neutralizing antibodies detected, throughout the longest-duration study of a PCSK9 inhibitor reported to date. (Open Label Study of Long Term Evaluation Against LDL-C Trial [OSLER-1]; NCT01439880).",2019,"Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization.","['1,151 patients (efficacy analysis population) progressed to the all-evolocumab period (year 2 and beyond', '1,255 patients (safety analysis population) randomized into the year 1 SOC-controlled period and received\xa0≥1 evolocumab dose (mean ± SD age 57 ± 12 years; 53% female', 'Patients With Hypercholesterolemia', 'high-risk patients over\xa0<3 years median treatment duration']","['Evolocumab and other anti-PCSK9 antibodies', 'Evolocumab', 'Evolocumab\xa0+ SOC', 'standard of care (SOC) or evolocumab 420\xa0mg monthly (evolocumab\xa0+ SOC', 'evolocumab\xa0+ SOC', 'evolocumab']","['adverse cardiovascular outcomes', 'mean\xa0± SE low-density lipoprotein cholesterol (LDL-C', 'Yearly serious AE rates', 'excellent LDL-C-lowering efficacy, tolerance, and safety\xa0of evolocumab', 'Mean baseline LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}]",1255.0,0.239866,"Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center for Clinical Research, Jacksonville, Florida. Electronic address: mkoren@encoredocs.com.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Thrombolysis In Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Thrombolysis In Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gisle', 'Initials': 'G', 'LastName': 'Langslet', 'Affiliation': 'Lipid Clinic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Thrombolysis In Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': 'Amgen, One Amgen Center Drive, Thousand Oaks, California.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Amgen, One Amgen Center Drive, Thousand Oaks, California.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Hamer', 'Affiliation': 'Amgen, One Amgen Center Drive, Thousand Oaks, California.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Amgen, One Amgen Center Drive, Thousand Oaks, California.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'The Carbohydrate and Lipid Metabolism Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.08.1024'] 1322,30025522,The effects of magnesium and vitamin E co-supplementation on parameters of glucose homeostasis and lipid profiles in patients with gestational diabetes.,"BACKGROUND Magnesium and vitamin E are known to exert multiple beneficial effects, such as anti-glycemic and anti-lipidemic properties. The aim of this study was to determine the effects of magnesium and vitamin E co-supplementation on metabolic status of women with gestational diabetes (GDM). METHODS This randomized, double-blinded, placebo-controlled trial was conducted among 60 subjects diagnosed with GDM, aged 18-40 years. Subjects were randomly allocated into two groups to receive 250 mg/day magnesium oxide plus 400 IU/day vitamin E supplements or placebo (n = 30 each group) for 6 weeks. Participants' blood samples were taken to determine their metabolic profiles. RESULTS Subjects who received magnesium plus vitamin E supplements had significantly lower fasting plasma glucose (β - 5.20 mg/dL; 95% CI, - 7.88, - 2.52; P = 0.002), serum insulin levels (β - 2.93 μIU/mL; 95% CI, - 5.68, - 0.18; P = 0.02) and homeostasis model of assessment-insulin resistance (β - 0.78; 95% CI, - 1.42, - 0.14; P = 0.01), and higher quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.005, 0.02; P = 0.002) compared with placebo. In addition, magnesium plus vitamin E supplementation resulted in a significant reduction in serum triglycerides (β - 50.31 mg/dL; 95% CI, - 67.58, - 33.04; P < 0.001), VLDL- (β - 10.06 mg/dL; 95% CI, - 13.51, - 6.60; P < 0.001), total- (β - 26.10 mg/dL; 95% CI, - 41.88, - 10.33; P = 0.004), LDL- (β - 15.20 mg/dL; 95% CI, - 29.50, - 0.91; P = 0.03) and total-/HDL-cholesterol ratio (β - 0.46; 95% CI, - 0.72, - 0.19; P < 0.001) compared with placebo. Magnesium and vitamin E co-supplementation did not affect HDL-cholesterol levels. CONCLUSIONS Overall, magnesium and vitamin E co-supplementation for 6 weeks in women with GDM significantly improved glycemic control and lipid profiles, except for HDL-cholesterol levels. CLINICAL TRIAL REGISTRATION NUMBER http://www.irct.ir : IRCT20170513033941N24.",2018,"RESULTS Subjects who received magnesium plus vitamin E supplements had significantly lower fasting plasma glucose (β - 5.20 ","['patients with gestational diabetes', 'women with gestational diabetes (GDM', '60 subjects diagnosed with GDM, aged 18-40\xa0years']","['magnesium plus vitamin E supplements', 'magnesium plus vitamin E supplementation', 'placebo', 'magnesium and vitamin E co-supplementation', '250\xa0mg/day magnesium oxide plus 400\xa0IU/day vitamin E supplements or placebo', 'Magnesium and vitamin E co-supplementation', 'Magnesium and vitamin E']","['glucose homeostasis and lipid profiles', 'homeostasis model of assessment-insulin resistance', 'serum insulin levels', 'metabolic status', 'serum triglycerides', 'total-/HDL-cholesterol ratio', 'VLDL', 'higher quantitative insulin sensitivity check index', 'HDL-cholesterol levels', 'glycemic control and lipid profiles, except for HDL-cholesterol levels', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",60.0,0.724907,"RESULTS Subjects who received magnesium plus vitamin E supplements had significantly lower fasting plasma glucose (β - 5.20 ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maktabi', 'Affiliation': 'Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamani', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Lipids in health and disease,['10.1186/s12944-018-0814-5'] 1323,29951902,Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: a Quasi-Experimental Study.,"Educational programs are important tools for breast cancer prevention. The purpose of this study was to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer. A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method and non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n = 75) were compared to the control group (n = 75) at baseline, as well as at 6 weeks and 3 months post-intervention. Knowledge of breast cancer screening tools was measured using a modified version of the Breast Cancer Knowledge test. Breast self-examination, clinical breast examination, and mammography practices were also measured. Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention. Thus, the results of this study provide evidence that group health education programs are effective in improving breast cancer knowledge and practices in female teachers. Clinical Trial Registration number: NCT03398057 .",2019,"Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention.","[""Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area"", '150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education', 'Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school']","['health education', 'Health Education']",['knowledge and practice levels'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[{'cui': 'C0018701'}],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",150.0,0.0138091,"Compared to the control group, the intervention group showed a statistically significant increase in knowledge and practice levels at both 6 weeks and 3 months post-intervention.","[{'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Alameer', 'Affiliation': 'Jazan Health Directorate, Ministry of Health, P.O. Box 1121, Abu Arish 45911, Jazan, Saudi Arabia. Alameeranwar@hotmail.com.'}, {'ForeName': 'Mohamed Salih', 'Initials': 'MS', 'LastName': 'Mahfouz', 'Affiliation': 'Family and Community Medicine Department, Faculty of Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Alamir', 'Affiliation': 'Health Education and Promotion Department, Faculty of Public health and Tropical Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Health Education and Promotion Department, Faculty of Public health and Tropical Medicine, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Darraj', 'Affiliation': 'Jazan Health Directorate, Ministry of Health, P.O. Box 1121, Abu Arish 45911, Jazan, Saudi Arabia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1386-9'] 1324,31358379,"Re: Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial.",,2019,,['Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223'],"['Placebo', 'Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]",[],,0.506997,,"[{'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: h.vd.poel@nki.nl.'}]",European urology,['10.1016/j.eururo.2019.07.021'] 1325,31636243,Effects of adding dexmedetomidine to local infiltration of bupivacaine on postoperative pain in pediatric herniorrhaphy: a randomized clinical trial.,"BACKGROUND Postoperative pain is a major problem, especially in children, as their tolerance level is lower and several drugs are contraindicated in childhood. This study aimed to compare the effect of dexmedetomidine added to local infiltration of bupivacaine for postoperative pain relief in children undergoing inguinal herniorrhaphy. METHODS This double-blind, randomized clinical trial included 60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals in Shiraz, Iran, randomly allocated into two groups, 30 in each group. One group received 1 µg/kg dexmedetomidine plus local infiltration of 0.2 ml/kg bupivacaine 0.5% at the incision site before surgery (BD), and the other group received bupivacaine and normal saline (BO). Analgesic requirements, emergence time, and nausea/vomiting, postoperative pain and sedation scores were assessed for 4 h after the operation. Heart rate (HR), systolic blood pressure (SBP), and oxygen saturation (SaO2) were recorded at baseline, and at 10 and 20 min after injection. RESULTS Eighty percent were boy in each group; mean age was 22.75 ± 18.63 months. SaO2 and SBP were not different between the groups, while HR was significantly lower in the BD group at 10 and 20 min after injection (P <0.05). BD group had a lower pain score at 1 and 2 h after the operation, a higher sedation score at the first three time intervals, and longer emergence time than BO group (all P <0.001). BD group had a lower pain score at 1 and 2 h after the operation (P < 0.001, P < 0.047 respectively). CONCLUSIONS Addition of dexmedetomidine to local infiltration of bupivacaine in children undergoing herniorrhaphy significantly reduced postoperative pain and increased sedation.",2020,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","['children undergoing inguinal herniorrhaphy', '60 patients were recruited in the study, 30 in each group', '24 patients (80%) were boys and 6 (20%) were girls', 'children undergoing', '60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals, Shiraz, Iran', 'Pediatric Herniorrhaphy']","['herniorrhaphy', 'dexmedetomidine', 'Dexmedetomidine', 'bupivacaine and normal saline (BO', 'dexmedetomidine plus local infiltration of 0.2 mL/kg bupivacaine', 'bupivacaine', 'Bupivacaine']","['postoperative pain', 'pain score', 'Heart rate (HR), systolic blood pressure (SBP), and arterial oxygen saturation (SaO2', 'Postoperative pain and sedation score', 'Analgesic requirements, emergence time, and nausea/vomiting', 'Postoperative Pain', 'Sedation score', 'emergence time', 'SaO2 and SBP, while HR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",60.0,0.299113,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Pourali', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Korean journal of anesthesiology,['10.4097/kja.19111'] 1326,31628698,"Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.","OBJECTIVE To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538). METHODS In this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean differences (LSMD); P-values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored. RESULTS Cariprazine 1.5 mg/day significantly reduced depressive symptoms on the primary (MADRS LSMD = -2.5; adjusted P = .0417) and secondary (CGI-S LSMD = -0.3; adjusted P = .0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0 mg/day. Common treatment-emergent AEs (≥5% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. CONCLUSIONS Cariprazine 1.5 mg/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0 mg/day. The safety and tolerability profiles were similar to previous studies of cariprazine.",2020,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. ","['adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5 th Edition criteria and a current depressive episode', 'bipolar I depression']","['placebo', 'cariprazine 1.5 mg/day[d', 'Cariprazine', 'cariprazine']","['depressive symptoms', 'safety and tolerability profiles', 'Mean metabolic parameter changes', 'akathisia, restlessness, nausea, and fatigue', 'mean weight increases', 'Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores', 'Adverse events (AEs), laboratory results, vital signs, and suicide risk', 'Efficacy and safety', 'efficacy, safety, and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4056789', 'cui_str': 'cariprazine 1.5 MG'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518766'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}]",,0.20525,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. ","[{'ForeName': 'Willie R', 'Initials': 'WR', 'LastName': 'Earley', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Burgess', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ludmyla', 'Initials': 'L', 'LastName': 'Rekeda', 'Affiliation': 'Department of Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine and V.A. Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}]",Bipolar disorders,['10.1111/bdi.12852'] 1327,31875756,Efficacy of the bispectral index and Observer's Assessment of Alertness/Sedation Scale in monitoring sedation during spinal anesthesia: A randomized clinical trial.,"OBJECTIVE The bispectral index (BIS) has been used to monitor sedation during spinal anesthesia. We evaluated the correlation between BIS and the Observer's Assessment of Alertness/Sedation Scale (OAA/S) in patients sedated with dexmedetomidine, propofol, or midazolam. METHODS This prospective, randomized study included 46 patients scheduled for knee arthroplasty under spinal anesthesia with sedation. The patients were randomized to receive sedation with dexmedetomidine (n = 15), propofol (n = 15), or midazolam (n = 16). Correlation between BIS and OAA/S was assessed during sedation in the three groups. RESULTS A linear correlation was observed between BIS and OAA/S, and there was no significant difference in BIS score between the groups during mild to moderate sedation status (OAA/S 3-5). During deep sedation (OAA/S 1-2), the BIS score in the midazolam group was significantly higher than that in the propofol and dexmedetomidine groups (74.4 ± 11.9 vs 67.7 ±  9.5 vs 62.6 ± 12.2). CONCLUSIONS BIS values differed at the same level of sedation between different sedative agents. Objective sedation scores should therefore be used in combination with BIS values for the assessment of sedation levels during spinal anesthesia.",2019,,['monitoring sedation during spinal anesthesia'],"[""bispectral index and Observer's Assessment of Alertness/Sedation Scale""]",[],"[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}]",[],,0.0547372,,"[{'ForeName': 'Tae Wan', 'Initials': 'TW', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Yi Hwa', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jong Bum', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Soo Kyung', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Youn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Jun Suck', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060519893165'] 1328,31933020,A Behavioral Adherence Intervention Improves Rates of Viral Suppression Among Adherence-Challenged People Living with HIV in South India.,"The success of antiretroviral therapy (ART) has led to both extended life expectancy and improved quality of life among people living with HIV (PLWH). To maximize the efficacy of first line ART regimens in low- and middle-income countries (LMIC), we need culturally-relevant interventions that empower participants to reduce barriers to long-term uninterrupted adherence. The Chetana adherence intervention trial was designed in collaboration with local community groups as a comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques. Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm. They were also about twice as likely as control arm participants to self-report ≥ 95% adherence (AOR = 1.86, 95% CI [1.09, 3.15]), and as having eliminated individual adherence barriers (AOR = 2.33, 95% CI [1.51, 3.62]) and clinic attendance barriers (AOR = 2.01, 95% CI [1.20, 3.38]) These low-cost strategies can be implemented by local NGOs, making it both scalable and sustainable in this and similar settings.",2020,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","['low- and middle-income countries (LMIC', 'Living with HIV in South India', 'people living with HIV (PLWH', 'Adherence-Challenged People']","['comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques', 'Behavioral Adherence Intervention', 'antiretroviral therapy (ART']","['quality of life', 'Viral Suppression', 'clinic attendance barriers']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0034380'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0717147,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA. Maria.Ekstrand@ucsf.edu.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Shoba', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Ranjani', 'Initials': 'R', 'LastName': 'Shamsundar', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'B N Ravi', 'Initials': 'BNR', 'LastName': 'Kumar', 'Affiliation': 'Karnataka State AIDS Prevention Society, Bangalore, India.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Chandy', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}]",AIDS and behavior,['10.1007/s10461-020-02785-6'] 1329,31605929,Influence of shading technique on mechanical fatigue performance and optical properties of a 4Y-TZP ceramic for monolithic restorations.,"This study aimed to evaluate the effect of shading procedures on the fatigue performance and optical properties of an yttria-stabilized tetragonal zirconia polycrystal ceramic (4Y-TZP - stabilized by 4 mol% Y 2 O 3 ). Disc-shaped specimens were produced at pre-sintered stage and randomly allocated into 5 groups (n=15) considering the shading technique: Ctrl (no pigmentation); Brush 1× and Brush 3× (brushing on 1 or 3 applications, respectively); Immer 2min and Immer 4min (immersion for 2 or 4 min, respectively). Following each pigment application, the specimens were dried in accordance with the manufacturers' guidelines (15 min in a stove at 70 °C) and sintered in a specific furnace. Biaxial flexural fatigue test followed a step-stress approach (initial strength: 200 MPa; step-size: 25 MPa; 10.000 cycles/step; frequency: 20 Hz). Optical measurements were conducted in a spectrophotometer following the CIEDE2000 parameters. Roughness, topography, crystalline grain size, crystalline phase content and fractography analysis were also performed. The flexural fatigue strength (FFS) and the number of cycles to fracture (CFF) were statistically affected by pigmentation techniques (mean FFS in MPa/mean CFF): Ctrl (446.7/105,619) > Brush 1 × (436.7/102,854) ≥ Brush 3 × (405.0/89,962) ≥ Immer 2 min (395.0/85,103) ≥ Immer 4 min (383.3/81,382), although the exposure intensity (increase in number of applications or in application time) to the pigment had no effect (Brush 1 × = Brush 3 × ; Immer 2 min = Immer 4 min). Regarding optical properties, shading techniques similarly affected translucency and opalescence parameters, regardless of the exposure intensity to the pigment (Brush 1 × = Brush 3 × = Immer 2 min = Immer 4 min > Ctrl), whereas the exposure intensity to the pigment only promoted relevant alterations in the color change parameter (ΔE 00 ) for the brushing technique (Brush 3 × > Brush 1 × ). No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected. Thus, the shading technique might affect the fatigue behavior and promote optical changes in a 4Y-TZP ceramic.",2020,"No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected.",['monolithic restorations'],"['shading procedures', 'yttria-stabilized tetragonal zirconia polycrystal ceramic', 'shading technique: Ctrl (no pigmentation); Brush 1× and Brush 3× (brushing on 1 or 3 applications, respectively); Immer 2min and Immer 4min (immersion', 'shading technique']","['mechanical fatigue performance and optical properties', 'flexural fatigue strength (FFS) and the number of cycles to fracture (CFF', 'crystalline phase content, topographic pattern or roughness', 'number of applications or in application time', 'fatigue performance and optical properties', 'zirconia grain size', 'Roughness, topography, crystalline grain size, crystalline phase content and fractography analysis']","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1568826', 'cui_str': 'Yttria-Stabilized Tetragonal Zirconia Polycrystals Ceramic'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0439748', 'cui_str': 'Flexural (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.0263486,"No difference was observed in crystalline phase content, topographic pattern or roughness, although an increase in the zirconia grain size could be detected.","[{'ForeName': 'Maria Luiza', 'Initials': 'ML', 'LastName': 'Auzani', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: marialuizaauzani@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Graduate Programs in Oral Science - Prosthodontic Units, Faculty of Odontology, Federal University of Santa Maria - UFSM, Santa Maria, Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2019.103457'] 1330,31268132,A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children.,"BACKGROUND Child development is affected by multiple factors throughout pregnancy and childhood. Multisectoral programs addressing these factors may improve children's development. OBJECTIVE We evaluated the impact of a food-assisted multisectoral nutrition program (Tubaramure) on children's (4-41.9 mo) motor and language development. Tubaramure was targeted to Burundian women and children in the first 1000 d and provided micronutrient-fortified food rations; nutrition, health, and hygiene behavior change communication; and health system-strengthening activities. METHODS Program impact was assessed using a cluster-randomized controlled trial with repeated cross-sections: 2010 (baseline, children 4-41.9 mo), 2012 (follow-up during implementation, children 4-23.9 mo), and 2014 (follow-up postimplementation, children 24-41.9 mo). Sixty villages were randomly assigned to 4 groups with varying timing and duration of food rations: pregnancy-24 mo; pregnancy-18 mo; 0-24 mo; and control, no direct Tubaramure benefits. Treatment groups were pooled and compared with control using difference-in-difference estimates. We examined impact pathways by assessing program impacts on intermediary variables and their associations with development outcomes. RESULTS At first follow-up, Tubaramure positively affected language (0.4 milestones, P < 0.05) but not motor development among children aged 4-23.9 mo. Among the 12-23.9 mo age subgroup, the program positively affected language (0.7 milestones, P < 0.01) and motor (0.6 milestones, P = 0.08) development. At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09). In age subgroup analyses, program impacts were limited to children aged 24-29.9 mo [0.4 motor (P = 0.09) and 1.0 language (P < 0.01) milestones]. Pathway analyses revealed significant positive impacts on diet, health, and nutritional indicators of children aged 12-23.9 mo and health and nutritional indicators of children aged 24-29.9 mo, supporting the plausibility of program impacts on child development. CONCLUSIONS Tubaramure had small positive impacts on children's motor and language development through multiple pathways, demonstrating the role multisectoral nutrition programs can play in improving children's development. This trial was registered at clinicaltrials.gov as NCT01072279.",2019,"At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09).","['Sixty villages', 'children 4-41.9 mo), 2012 (follow-up during implementation, children 4-23.9 mo), and 2014 (follow-up postimplementation, children 24-41.9 mo', 'Young Burundian Children', ""children's (4-41.9 mo) motor and language development""]","['Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program', 'food rations: pregnancy-24 mo; pregnancy-18 mo; 0-24 mo; and control, no direct Tubaramure benefits', 'food-assisted multisectoral nutrition program (Tubaramure']","['Attainment of Language and Motor Milestones', 'diet, health, and nutritional indicators', 'motor development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0243107', 'cui_str': 'development'}]",60.0,0.0661882,"At second follow-up, among children aged 24-41.9 mo, Tubaramure marginally affected motor development (0.4 milestones, P = 0.09).","[{'ForeName': 'Deanna K', 'Initials': 'DK', 'LastName': 'Olney', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Jef L', 'Initials': 'JL', 'LastName': 'Leroy', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Bliznashka', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Ruel', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz133'] 1331,31271193,The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults.,"BACKGROUND The phenylalanine requirement of the elderly is not known. Current recommendations are based on studies in young adults and are derived from a combined estimate of the total aromatic amino acids, phenylalanine, and tyrosine. OBJECTIVES The purpose of this study was to determine the dietary phenylalanine requirement of adults aged >65 y, using the direct amino acid oxidation method, by measuring the oxidation of l-[1-13C]phenylalanine to 13CO2 in response to graded phenylalanine intakes in the presence of excess tyrosine. METHODS Twelve subjects (6 men, 6 women), aged 73.8 ± 6.7 y (mean ± SD) and with a BMI (in kg/m2) of 26.4 ± 4.8 and 25.2 ± 4.4 for men and women, respectively, were randomized to phenylalanine intakes ranging from 7.20 to 40.0 mg .kg-1 .d-1 for a total of 66 studies. Study diets were isocaloric and isonitrogenous, providing protein and energy at 1.0 g .kg-1 .d-1 and 1.5 × resting energy expenditure (REE), respectively. Protein was provided as an amino acid mixture patterned after egg protein, with an excess of tyrosine and alanine to balance the nitrogen as phenylalanine intakes were varied. Two days prior to the study day, subjects were adapted to a milkshake diet providing protein at 1.0 g.kg-1 .d-1 and energy at 1.7 × REE. The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. RESULTS The mean and upper 95% CIs (approximating the recommended dietary allowance) of phenylalanine requirements were estimated to be 9.03 and 15.9 mg.kg-1 .d-1, respectively. CONCLUSION These results are similar to previously derived estimates of 9.1 and 13.6 mg.kg-1 .d-1 in young adult men and suggest that higher protein needs of the elderly to stimulate similar muscle protein synthesis rates as young adults are not driven by an increased requirement for phenylalanine. This trial was registered at clinicaltrials.gov as NCT02971059.",2019,"The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. ","['young adults', 'adults aged >65 y', 'Twelve subjects (6 men, 6 women), aged 73.8\xa0±\xa06.7 y (mean\xa0±\xa0SD) and with a BMI (in kg/m2) of 26.4\xa0±\xa04.8 and 25.2\xa0±\xa04.4 for men and women', 'Elderly Men and Women', 'young adult men']",['phenylalanine intakes ranging from 7.20 to 40.0 mg .kg-1'],['mean phenylalanine requirement'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}]","[{'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}]",,0.0667737,"The mean phenylalanine requirement was determined using biphase linear regression analysis, which identified a breakpoint in the F13CO2 in response to graded phenylalanine intakes. ","[{'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sylwia', 'Initials': 'S', 'LastName': 'Szwiega', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz137'] 1332,29723595,Cost-Effectiveness Benefits of a Disease Management Program:The REMADHE Trial Results.,"BACKGROUND Published studies have generated mixed, controversial results regarding the cost-effectiveness of heart failure disease management programs (HF-DMPs). This study assessed the cost-effectiveness of an HF-DMP in ambulatory patients compared with usual care (UC). METHODS In the prospective randomized REMADHE trial, we evaluated incremental costs per quality-adjusted life-year (QALY) and life-year (LY) gained as effectiveness ratios (ICERs) over a study period of 2.47 ± 1.75 years. RESULTS The REMADHE HF-DMP was more effective and less costly than UC in terms of both QALYs and LYs (95% and 55% chance of dominance, respectively). Average saving was US$7345 (2.5%-97.5% bootstrapped confidence interval -16,573 to +921). The chance of DMP being cost-effective at a willingness to pay US$10,000 per QALY or LY was 99% and 96%, respectively. Cost-effectiveness of HF-DMP was highest in subgroups with left ventricular ejection fraction <35%, age >50 years, male sex, New York Heart Association (NYHA) functional class ≥III, and ischemic etiology. The chance of DMP being cost-effective at a willingness to pay US$10,000 per QALY was ≥90% in all subgroups apart from NYHA functional class I-II, where it was 70%. Even when the intervention costs increased by 500% or when excluding outliers in costs, DMP had a high chance of being cost-effective (87%-99%). CONCLUSIONS The HF-DMP of the REMADHE trial, which encompasses long-term repeated education alongside telephone monitoring, has a high probability of being cost-effective in ambulatory patients with HF.",2018,"The REMADHE HF-DMP was more effective and less costly than UC in terms of both QALYs and LYs (95% and 55% chance of dominance, respectively).","['ambulatory patients compared with usual care (UC', 'ambulatory patients with HF', 'subgroups with left ventricular ejection fraction <35%, age >50 years, male sex, New York Heart Association (NYHA) functional class ≥III, and ischemic etiology']","['HF-DMP', 'Disease Management Program']","['Average saving', 'incremental costs per quality-adjusted life-year (QALY) and life-year (LY) gained as effectiveness ratios (ICERs', 'chance of DMP being cost-effective', 'cost-effectiveness']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}]","[{'cui': 'C0041738', 'cui_str': 'Unithiol'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}]","[{'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041738', 'cui_str': 'Unithiol'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0258734,"The REMADHE HF-DMP was more effective and less costly than UC in terms of both QALYs and LYs (95% and 55% chance of dominance, respectively).","[{'ForeName': 'Edimar Alcides', 'Initials': 'EA', 'LastName': 'Bocchi', 'Affiliation': 'Heart Institute (Incor) of São Paulo University Medical School (HCFUMSP), São Paulo, Brazil. Electronic address: dcledimar@incor.usp.br.'}, {'ForeName': 'FÁtima das Dores', 'Initials': 'FDD', 'LastName': 'da Cruz', 'Affiliation': 'Heart Institute (Incor) of São Paulo University Medical School (HCFUMSP), São Paulo, Brazil.'}, {'ForeName': 'Sara Michelly', 'Initials': 'SM', 'LastName': 'BrandÃo', 'Affiliation': 'Heart Institute (Incor) of São Paulo University Medical School (HCFUMSP), São Paulo, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Issa', 'Affiliation': 'Heart Institute (Incor) of São Paulo University Medical School (HCFUMSP), São Paulo, Brazil.'}, {'ForeName': 'Silvia Moreira', 'Initials': 'SM', 'LastName': 'Ayub-Ferreira', 'Affiliation': 'Heart Institute (Incor) of São Paulo University Medical School (HCFUMSP), São Paulo, Brazil.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner la Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.'}, {'ForeName': 'Sandra Sanders-van', 'Initials': 'SS', 'LastName': 'Wijk', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2018.04.008'] 1333,31551249,Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes.,"OBJECTIVE Hepatic-directed vesicle insulin (HDV) uses a hepatocyte-targeting moiety passively attaching free insulin, improving subcutaneous insulin's hepatic biodistribution. We assessed HDV-insulin lispro (HDV-L) versus insulin lispro (LIS) in type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS Insulin Liver Effect (ISLE-1) was a 26-week, phase 2b, multicenter, randomized, double-blind, noninferiority trial. RESULTS Among 176 randomized participants (HDV-L n = 118, LIS n = 58), the difference in change from baseline A1C was 0.09% (95% CI -0.18% to 0.35%), confirming noninferiority (prespecified margin ≤0.4%). Overall, there were no statistically significant differences between treatments for hypoglycemia or insulin dosing. However, baseline A1C modified the treatment group effect (interaction P < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe. Thus, at higher baseline A1C, there was less hypoglycemia and lower insulin dosing with similar A1C outcomes during HDV-L versus LIS, whereas greater risk of hypoglycemia despite similar A1C outcomes and insulin doses was observed with lower baseline A1C. Among poorly controlled participants (A1C ≥8.5%), incidence rates of severe hypoglycemia in the HDV-L and LIS arms were 69 and 97 events/100 person-years, respectively ( P = 0.03), whereas with A1C <8.5%, respective rates were 191 and 21 events/100 person-years ( P = 0.001). Similar A1C-dependent trends in hypoglycemia were seen with continuous glucose monitoring. Among poorly controlled participants, bolus insulin doses at end point were ∼25% lower with HDV-L ( P = 0.02), despite similar A1C outcomes; in better-controlled participants, insulin doses and A1Cs were stable over time in both subgroups. No safety signals were identified. CONCLUSIONS Hepatic biodistribution of HDV-L appears to potentiate insulin effect in T1D, with divergent clinical outcomes in hypoglycemia dependent on baseline A1C.",2019,"However, baseline A1C modified the treatment group effect (interaction P < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe.",['type 1 diabetes (T1D'],['Hepatic-Directed Prandial Insulin'],"['HDV-insulin lispro (HDV-L) versus insulin lispro (LIS', 'hypoglycemia', 'incidence rates of severe hypoglycemia', 'risk of hypoglycemia despite similar A1C outcomes and insulin doses']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",176.0,0.203641,"However, baseline A1C modified the treatment group effect (interaction P < 0.001) on clinically apparent hypoglycemia designated by treatment-blinded investigators as severe.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klonoff', 'Affiliation': 'Mills-Peninsula Medical Center, San Mateo, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Penn', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH.'}, {'ForeName': 'W Blair', 'Initials': 'WB', 'LastName': 'Geho', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Muchmore', 'Affiliation': 'Diasome Pharmaceuticals, Inc., Cleveland, OH dmuchmore@diasome.com.'}]",Diabetes care,['10.2337/dc19-0152'] 1334,29475381,Motivational impairment predicts functional remission in first-episode psychosis: 3-Year follow-up of the randomized controlled trial on extended early intervention.,"OBJECTIVE Functional remission represents an intermediate functional milestone toward recovery. Differential relationships of negative symptom sub-domains with functional remission in first-episode psychosis are understudied. We aimed to examine rate and predictors of functional remission in people with first-episode psychosis in the context of a 3-year follow-up of a randomized controlled trial comparing 1-year extension of early intervention (i.e. 3-year early intervention) with step-down psychiatric care (i.e. 2-year early intervention). METHOD A total of 160 participants were recruited upon completion of a 2-year specialized early intervention program for first-episode psychosis in Hong Kong and underwent a 1-year randomized controlled trial comparing 1-year extended early intervention with step-down care. Participants were followed up and reassessed 3 years after inclusion to the trial (i.e. 3-year follow-up). Functional remission was operationalized as simultaneous fulfillment of attaining adequate functioning (measured by Social and Occupational Functioning Scale and Role Functioning Scale) at 3-year follow-up and sustained employment in the last 6 months of 3-year study period. Negative symptom measure was delineated into amotivation (i.e. motivational impairment) and diminished expression (i.e. reduced affect and speech output). Data analysis was based on 143 participants who completed follow-up functional assessments. RESULTS A total of 31 (21.7%) participants achieved functional remission status at 3-year follow-up. Multivariate regression analysis showed that lower levels of amotivation ( p  = 0.010) and better functioning at study intake ( p  = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p  < 0.001). Extended early intervention, duration of untreated psychosis and diminished expression did not predict functional remission. CONCLUSION Only approximately one-fifths of early psychosis patients were found to achieve functional remission. Functional impairment remains an unmet treatment need in the early stage of psychotic illness. Our results further suggest that amotivation may represent a critical therapeutic target for functional remission attainment in early psychosis.",2018,"Multivariate regression analysis showed that lower levels of amotivation ( p = 0.010) and better functioning at study intake ( p = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p < 0.001).","['people with first-episode psychosis', 'first-episode psychosis', '143 participants who completed follow-up functional assessments', '160 participants were recruited upon completion of a 2-year specialized early intervention program for first-episode psychosis in Hong Kong and underwent a 1-year randomized controlled trial comparing']","['early intervention (i.e. 3-year early intervention) with step-down psychiatric care (i.e. 2-year early intervention', '1-year extended early intervention with step-down care', 'Motivational impairment']","['levels of amotivation', 'functional remission status', 'functional remission', 'Social and Occupational Functioning Scale and Role Functioning Scale', 'Functional remission']","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}]","[{'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",160.0,0.11344,"Multivariate regression analysis showed that lower levels of amotivation ( p = 0.010) and better functioning at study intake ( p = 0.004) independently predicted functional remission (Final model: Nagelkerke R 2  = 0.40, χ 2  = 42.9, p < 0.001).","[{'ForeName': 'Wing Chung', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Vivian Wing Yan', 'Initials': 'VWY', 'LastName': 'Kwong', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Or Chi Fai', 'Affiliation': 'Department of Psychiatry, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Emily Sin Kei', 'Initials': 'ESK', 'LastName': 'Lau', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Gloria Hoi Kei', 'Initials': 'GHK', 'LastName': 'Chan', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Olivia Tsz Ting', 'Initials': 'OTT', 'LastName': 'Jim', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Christy Lai Ming', 'Initials': 'CLM', 'LastName': 'Hui', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sherry Kit Wa', 'Initials': 'SKW', 'LastName': 'Chan', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edwin Ho Ming', 'Initials': 'EHM', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric Yu Hai', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Queen Mary Hospital and Department of Psychiatry, The University of Hong Kong, Hong Kong, China.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867418758918'] 1335,31625952,"Feasibility, Acceptability, and Preliminary Impacts of Web-Based Patient Education on Patients With Schizophrenia Spectrum Disorder: Quasi-Experimental Cluster Study.","BACKGROUND Web-based interventions are promising tools for increasing the understanding of illness and treatment among patients with serious mental disorders. OBJECTIVE This study aimed to test the feasibility and acceptability of a Web-based patient education intervention using a quasi-experimental cluster design to report feedback on patient education sessions and the website used and to report preliminary evidence of the intervention's impact on patients with schizophrenia spectrum disorder. METHODS A single-blind, parallel, quasi-experimental cluster study over a 6-month period comparing Web-based education (n=33) with a nonequivalent control group (treatment as usual, n=24) for people with schizophrenia spectrum disorder was conducted. Participants (N=57) were recruited from one psychiatric hospital (6 wards). Feasibility was assessed by participants' commitment (refusal rate, dropout rate) to the study. Acceptability was assessed as participants' commitment to the intervention. Patient education sessions and website feedback were assessed by the patients and health care professionals. The preliminary impact of the sessions on patients' self-efficacy, self-esteem, illness cognition, and knowledge level was measured at baseline and follow-ups (8 weeks, 6 months) with self-rated questionnaires. RESULTS The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21). The same result was found for the dropout rates (48% [16/33] vs 58% [14/24]; P=.46). The acceptability of the intervention was good; 31 participants out of 33 (94%) completed all five sessions. Feedback on the intervention was mainly positive; three out of four subscales of session were rated above the midpoint of 4.0. Feedback on the website was also positive, with a grade of good for content (69%, 20/29 patients; 75%, 21/28 professionals), layout (62%, 18/29 patients; 61%, 17/28 professionals), and usability (62%, 18/29 patients; and 68%, 19/28 professionals). The patients using the intervention had significantly higher scores 6 months after the sessions in self-efficacy (baseline mean 26.12, SD 5.64 vs 6-month mean 29.24, SD 6.05; P=.003) and regarding knowledge level about schizophrenia (mean 11.39, SD 4.65 vs 6-month mean 15.06, SD 5.26; P=.002), and lower scores in the subscale of helplessness in illness cognition (mean 2.26, SD 0.96 vs 6-month mean 1.85, SD 0.59; P=.03). Differences from the control group were not significant. No differences were found in patients' self-esteem or other subscales in illness cognition. CONCLUSIONS The patients were reluctant to participate in the study and tended to drop out before the follow-ups. Once they had participated, their acceptance of the intervention was high. A more effective recruitment strategy and monitoring method will be needed in future studies. To assess the impact of the intervention, a more rigorous study design with an adequately powered sample size will be used in cooperation with outpatient mental health services.",2019,"The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21).","['patients with schizophrenia spectrum disorder', 'people with schizophrenia spectrum disorder', 'patients with serious mental disorders', 'Participants (N=57) were recruited from one psychiatric hospital (6 wards', 'Patients With Schizophrenia Spectrum Disorder']","['Web-based patient education intervention', 'Web-Based Patient Education']","['dropout rates', 'refusal rate', 'knowledge level about schizophrenia', 'Acceptability', 'subscale of helplessness in illness cognition', ""patients' self-esteem or other subscales in illness cognition"", ""patients' self-efficacy, self-esteem, illness cognition, and knowledge level"", 'self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",31.0,0.050454,"The refusal rate among patients was high with no statistically significant difference (69% [74/107] in the intervention group, 76% [76/100] in the control group; P=.21).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Laine', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Maritta', 'Initials': 'M', 'LastName': 'Välimäki', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Virve', 'Initials': 'V', 'LastName': 'Pekurinen', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Marttunen', 'Affiliation': 'Institute of Criminology and Legal Policy, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Department of Nursing Science, University of Turku, Turku, Finland.'}]",Journal of medical Internet research,['10.2196/13073'] 1336,31585725,"Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.","BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6-23-month old Filipino children. METHODS This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6-23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination. RESULTS A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9-12 months, and 13-23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p < 0.0001]. A similar pattern of immunogenicity was reported across all age strata. The vaccine reported to be safe and well tolerated. CONCLUSIONS Vi-DT vaccine was immunogenic, safe, and well tolerated in children aged 6-23 months. ClinicalTrials.gov registration number: NCT03527355.",2020,"BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","['Muntinlupa City, The Philippines', 'healthy Filipino infants and toddlers', 'school-aged children', 'Participants aged 6-23\u202fmonths', '6-23-month old Filipino children', '285 participants were enrolled and age-stratified: 6 to < 9\u202fmonths, 9-12\u202fmonths, and 13-23\u202fmonths', 'Seventy-six (76) participants received', 'children aged 6-23\u202fmonths']","['Vi-DT vaccine', 'Vi-DT', 'placebo (0.9% sodium chloride', 'placebo', 'Vi-DT typhoid conjugate vaccine', 'Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT']","['safety, reactogenicity, and immunogenicity data', 'GMT', 'Immunogenicity, safety and reactogenicity', 'safe and well tolerated', 'immunogenicity, safety and reactogenicity']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1556093', 'cui_str': 'Filipinos (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0058773', 'cui_str': 'DT Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",285.0,0.64885,"BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea. Electronic address: tarun.saluja@ivi.int.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Ham', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",Vaccine,['10.1016/j.vaccine.2019.09.074'] 1337,29910056,Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial.,"OBJECTIVES SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC). BACKGROUND AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium. METHODS The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP). CONCLUSIONS This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome.",2018,"AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy.","['in cAncer survivors', 'subjects with anthracycline-induced cardiomyopathy (AIC', 'cAncer survivors', '36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy']","['open-label, lead-in phase and received 100 million allo-MSCs', 'allo-MSCs or vehicle via 20 transendocardial injections', 'SENECA (StEm cell iNjECtion', 'placebo', 'allo-MSCs', 'allogeneic mesenchymal stromal cells (allo-MSCs']","['MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}]",6.0,0.11393,"AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bolli', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Carrie G', 'Initials': 'CG', 'LastName': 'Lenneman', 'Affiliation': 'University of Louisville, Louisville, KY.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'March', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'University of Florida School of Medicine, Gainesville, Florida.'}, {'ForeName': 'Emerson C', 'Initials': 'EC', 'LastName': 'Perin', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health, Houston, TX.""}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Willerson', 'Affiliation': ""Texas Heart Institute, CHI St. Luke's Health, Houston, TX.""}, {'ForeName': 'Phillip C', 'Initials': 'PC', 'LastName': 'Yang', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Gee', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'João A', 'Initials': 'JA', 'LastName': 'Lima', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lem', 'Initials': 'L', 'LastName': 'Moyé', 'Affiliation': 'UT Health School of Public Health, Houston, TX. Electronic address: lemmoye@msn.com.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Vojvodic', 'Affiliation': 'UT Health School of Public Health, Houston, TX.'}, {'ForeName': 'Shelly L', 'Initials': 'SL', 'LastName': 'Sayre', 'Affiliation': 'UT Health School of Public Health, Houston, TX.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bettencourt', 'Affiliation': 'UT Health School of Public Health, Houston, TX.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'UT Health School of Public Health, Houston, TX.'}, {'ForeName': 'Ray F', 'Initials': 'RF', 'LastName': 'Ebert', 'Affiliation': 'NIH, National Heart, Lung, and Blood Institute, Bethesda, MD.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Simari', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2018.02.009'] 1338,31639775,A simple method to reduce halitosis; tongue scraping with probiotics.,"OBJECTIVE We aimed to assess the effects of probiotic implantation to the dorsum of the tongue against halitosis. MATERIALS AND METHODS 100 participants were randomly divided into three groups as tongue back scraping (TS), probiotic implantation to the dorsum of the tongue (PB) and mouthwash alone as the control group (MW). Measurements were taken before the treatment, after the first month of treatment and one month after the cessation of treatment. RESULTS Halimeter, winkel and woodlight scores were evaluated initially, in the first month and after the cessation of the treatment. All of MW measurements showed no difference throughout the study. All of TS measurements decreased significantly in the first month (p < 0.05) but rose again in the final count. All of PB measurements significantly decreased in the first month and kept their low levels after the cessation of the treatment (p < 0.05). CONCLUSION Probiotics and tongue scraping are widely used against halitosis but they are not intended to be used together. In this study, we proposed and proved an effective method of probiotic implantation by tongue scraping and showed that halitosis did not recur after the cessation of the treatment.",2019,All of TS measurements decreased significantly in the first month (p<0.05) but rose again in the final count.,['100 participants'],"['probiotic implantation', 'tongue back scraping (TS), probiotic implantation to the dorsum of the tongue (PB) and mouthwash alone as the control group (MW']","['PB measurements', 'TS measurements', 'Halimeter, winkel and woodlight scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0184933', 'cui_str': 'Scraping (procedure)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",100.0,0.0170555,All of TS measurements decreased significantly in the first month (p<0.05) but rose again in the final count.,"[{'ForeName': 'Berk', 'Initials': 'B', 'LastName': 'Gurpinar', 'Affiliation': 'Okmeydani Training and Research Hospital, Department of Otolaryngology, Istanbul, Turkey.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Yildirim', 'Affiliation': ''}, {'ForeName': 'Tolgar Lütfi', 'Initials': 'TL', 'LastName': 'Kumral', 'Affiliation': ''}, {'ForeName': 'Muhammed Fatih', 'Initials': 'MF', 'LastName': 'Akgun', 'Affiliation': ''}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Sari', 'Affiliation': ''}, {'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Tutar', 'Affiliation': ''}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': ''}]",Journal of breath research,['10.1088/1752-7163/ab503e'] 1339,31506757,Longitudinal Study of Sleep and Internalizing Problems in Youth Treated for Pediatric Anxiety Disorders.,"The current study examined prospective bidirectional links between dysregulated sleep, and anxiety and depression severity across 4 years, among youth with a history of anxiety disorder. Participants were 319 youth (age 11-26 years), who previously participated in a large multisite randomized controlled trial for the treatment of pediatric anxiety disorders, Child/Adolescent Anxiety Multimodal Study (CAMS), and subsequently enrolled in a naturalistic follow-up, Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), an average of 6.5 years later. They participated in four annual visits that included self-report items of dysregulated sleep and semi-structured multi-informant interviews of anxiety and depression. Dysregulated sleep was bidirectionally associated with clinician-rated anxiety and depression symptom severity across adolescence and young adulthood. However, these bidirectional relationships were attributable to youth mean levels of dysregulated sleep, and anxiety and depression severity over the 4 years. Elevations in dysregulated sleep at each visit, relative to mean levels, did not predict worse anxiety or depression severity 1 year later. Likewise visit-specific elevations in anxiety and depression severity, as opposed to average levels, did not predict higher levels of dysregulated sleep at the next visit. Having higher levels of dysregulated sleep or more severe internalizing problems across the four-year period, as opposed to reporting a relative increase in symptom severity at a particular visit, posed greater risk for poor mental health. Interventions should continue to assess and treat persistent sleep problems alongside anxiety and depression.",2020,"Elevations in dysregulated sleep at each visit, relative to mean levels, did not predict worse anxiety or depression severity 1 year later.","['Youth Treated for Pediatric Anxiety Disorders', 'Participants were 319 youth (age 11-26\xa0years), who previously participated in a large multisite randomized controlled trial for the treatment of pediatric anxiety disorders, Child/Adolescent Anxiety Multimodal Study (CAMS), and subsequently enrolled in a naturalistic follow-up, Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), an average of 6.5\xa0years later', 'youth with a history of anxiety disorder']",[],"['dysregulated sleep, and anxiety and depression severity', 'Dysregulated sleep']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",319.0,0.0208098,"Elevations in dysregulated sleep at each visit, relative to mean levels, did not predict worse anxiety or depression severity 1 year later.","[{'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Human Development and Family Studies, The Pennsylvania State University, 216 Health and Human Development, University Park, PA, 16802, USA. sub1164@psu.edu.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, NY, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Courtney P', 'Initials': 'CP', 'LastName': 'Keeton', 'Affiliation': 'Department of Psychiatry and Behavioral Services, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00582-x'] 1340,31871950,Effects of Highly Absorbable Curcumin in Patients with Impaired Glucose Tolerance and Non-Insulin-Dependent Diabetes Mellitus.,"Oxidative stress is enhanced by various mechanisms. Serum oxidized low-density lipoprotein (LDL) is a useful prognostic marker in diabetic patients with coronary artery disease. To examine the effects of Theracurmin®, a highly absorbable curcumin preparation, on glucose tolerance, adipocytokines, and oxidized LDL, we conducted a double-blind placebo-controlled parallel group randomized trial in patients with impaired glucose tolerance or non-insulin-dependent diabetes mellitus. We randomly divided the patients with impaired glucose tolerance or non-insulin-dependent diabetes mellitus and stable individuals into the placebo group and the Theracurmin® (180 mg daily for 6 months) group. Of the 33 patients analyzed, 18 (14 males and 4 females) were administered placebo and 15 (9 males and 6 females) were administered Theracurmin®. The patient characteristics did not differ between the two groups. The primary endpoint, HbA1c, did not differ significantly between the two groups. However, the level of α 1-antitrypsin-low-density lipoprotein (AT-LDL), the oxidized LDL, significantly increased ( p = 0.024) in the placebo group from the beginning of the trial up to 6 months, although there was no such change in the Theracurmin® group. The percentage change in BMI from the beginning of the trial up to 6 months tended to be higher in the Theracurmin® group than in the placebo group. Patients in the Theracurmin® group tended to have a larger percentage change in adiponectin and LDL-C than those in the placebo group. Patients in the Theracurmin® group showed a smaller percentage change in AT-LDL than those in the placebo group. This study suggests that the highly absorbable curcumin could potentially inhibit a rise in oxidized LDL in patients with impaired glucose tolerance or non-insulin-dependent diabetes mellitus. This trial is registered with UMIN000007361.",2019,Patients in the Theracurmin® group showed a smaller percentage change in AT-LDL than those in the placebo group.,"['33 patients analyzed, 18 (14 males and 4 females', 'patients with impaired glucose tolerance or non-insulin-dependent diabetes mellitus and stable individuals into the', 'diabetic patients with coronary artery disease', 'Patients with Impaired Glucose Tolerance and Non-Insulin-Dependent Diabetes Mellitus', 'patients with impaired glucose tolerance or non-insulin-dependent diabetes mellitus']","['Highly Absorbable Curcumin', 'Theracurmin®', 'placebo', 'Serum oxidized low-density lipoprotein (LDL']","['oxidized LDL', 'smaller percentage change in AT-LDL', 'percentage change in BMI', 'level of α 1-antitrypsin-low-density lipoprotein (AT-LDL), the oxidized LDL', 'adiponectin and LDL-C', 'Oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",,0.147247,Patients in the Theracurmin® group showed a smaller percentage change in AT-LDL than those in the placebo group.,"[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Funamoto', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Sunagawa', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Katanasaka', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kakeya', 'Affiliation': 'Department of System Chemotherapy and Molecular Sciences, Division of Bioinformatics and Chemical Genomics, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Yamakage', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Satoh-Asahara', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Wada', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka 422-8526, Japan.'}]",Journal of diabetes research,['10.1155/2019/8208237'] 1341,29644582,A Randomized Placebo-Controlled Cross-Over Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorder.,"Riluzole is a glutamatergic modulator of particular interest in autism spectrum disorder (ASD). In this 12-week randomized, double-blind, placebo-controlled, crossover pilot study we evaluated the safety and tolerability of 5-week of adjunctive riluzole treatment (vs. 5-week of placebo, with 2-week washout period) targeting ASD-associated drug-refractory irritability in eight individuals age 12-25 years. All participants tolerated riluzole 200 mg per day, however there were no statistically significant findings for the overall treatment effect, the treatment effect by week within period of the study, or a cross-over effect across the periods of the study on the Clinical Global Impression Improvement Scale or the Aberrant Behavior Checklist Irritability subscale. The results of this trial indicate that 5-week of riluzole treatment was well tolerated, but had no significant effect on the target symptoms. Trial Registration ClinicalTrials.gov Identifier NCT02081027, Registered 5 August 2013, First participant enrolled 19 September 2013.",2018,All participants tolerated riluzole,"['eight individuals age 12-25\xa0years', 'Registered 5 August 2013, First participant enrolled 19 September 2013', 'Autism Spectrum Disorder', 'autism spectrum disorder (ASD']","['placebo', 'Riluzole', 'adjunctive riluzole', 'Placebo', 'riluzole']","['Clinical Global Impression Improvement Scale or the Aberrant Behavior Checklist Irritability subscale', 'safety and tolerability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0443127', 'cui_str': 'Aberrant (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.262413,All participants tolerated riluzole,"[{'ForeName': 'Logan K', 'Initials': 'LK', 'LastName': 'Wink', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA. logan.wink@cchmc.org.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Tessier', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Bantel', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hong', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Shaffer', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Ernest V', 'Initials': 'EV', 'LastName': 'Pedapati', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH, 45229, USA.""}]",Journal of autism and developmental disorders,['10.1007/s10803-018-3562-5'] 1342,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study. RESEARCH DESIGN AND METHODS Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study. RESULTS A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI. CONCLUSIONS Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms; P < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms; P < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1; P < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993'] 1343,31622456,High Rates of Drug-induced Liver Injury in People Living With HIV Coinfected With Tuberculosis (TB) Irrespective of Antiretroviral Therapy Timing During Antituberculosis Treatment: Results From the Starting Antiretroviral Therapy at Three Points in TB Trial.,"BACKGROUND New onset or worsening drug-induced liver injury challenges coinfected patients on antiretroviral therapy (ART) initiation during antituberculosis (TB) treatment. METHODS Post hoc analysis within a randomized trial, the Starting Antiretroviral Therapy at Three Points in Tuberculosis trial, was conducted. Patients were randomized to initiate ART either early or late during TB treatment or after TB treatment completion. Liver enzymes were measured at baseline, 6-month intervals, and when clinically indicated. RESULTS Among 642 patients enrolled, the median age was 34 years (standard deviation, 28-40), and 17.6% had baseline CD4+ cell counts <50 cells/mm3. Overall, 146/472 patients (52, 47, and 47: early, late, and sequential arms) developed new-onset liver injury following TB treatment initiation. The incidence of liver injury post-ART initiation in patients with CD4+ cell counts <200 cells/mm3 and ≥200 cells/ mm3 was 27.4 (95% confidence interval [CI], 18.0-39.8), 19.0 (95% CI, 10.9-30.9), and 18.4 (95% CI, 8.8-33.8) per 100 person-years, and 32.1 (95% CI, 20.1-48.5), 11.8 (95% CI, 4.3-25.7), and 28.2 (95% CI, 13.5-51.9) per 100 person-years in the early, late integrated, and sequential treatment arms, respectively. Severe and life-threatening liver injury occurred in 2, 7, and 3 early, late, and sequential treatment arm patients, respectively. Older age and hepatitis B positivity predicted liver injury. CONCLUSIONS High incidence rates of liver injury among cotreated human immunodeficiency virus (HIV)-TB coinfected patients were observed. Clinical guidelines and policies must provide guidance on frequency of liver function monitoring for HIV-TB coinfected patients.",2020,"Severe and life-threatening liver injury occurred in 2, 7, and 3 early, late, and sequential treatment arm patients, respectively.","['People Living With HIV Coinfected With Tuberculosis (TB', 'human immunodeficiency virus (HIV)-tuberculosis (TB) coinfected patients receiving concomitant treatment for TB and HIV', '642 patients enrolled, the median age was 34 years (standard deviation, 28-40), and 17.6% had baseline CD4+ cell counts <50 cells/mm3', 'HIV-TB coinfected patients', 'Older age and hepatitis B positivity predicted liver injury']",[],"['incidence of liver injury post-ART initiation', 'Severe and life-threatening liver injury', 'Liver enzymes', 'new-onset liver injury']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",642.0,0.73579,"Severe and life-threatening liver injury occurred in 2, 7, and 3 early, late, and sequential treatment arm patients, respectively.","[{'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Razia', 'Initials': 'R', 'LastName': 'Hassan-Moosa', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Philile', 'Initials': 'P', 'LastName': 'Mlotshwa', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Yende-Zuma', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Dhineshree', 'Initials': 'D', 'LastName': 'Govender', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Nesri', 'Initials': 'N', 'LastName': 'Padayatchi', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}, {'ForeName': 'Salim S S', 'Initials': 'SSS', 'LastName': 'Abdool-Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, and.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz732'] 1344,31151675,"Re: Continuous Low-dose Antibiotic Prophylaxis for Adults with Repeated Urinary Tract Infections (AnTIC): A Randomized, Open-label Trial.",,2019,,['Adults with Repeated Urinary Tract Infections (AnTIC'],['Re: Continuous Low-dose Antibiotic Prophylaxis'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]",[],,0.0384076,,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}]",European urology,['10.1016/j.eururo.2019.05.018'] 1345,31573911,Tailored Web-Based Information for Younger and Older Patients with Cancer: Randomized Controlled Trial of a Preparatory Educational Intervention on Patient Outcomes.,"BACKGROUND Many patients with cancer, including older patients (aged ≥65 years), consult the Web to prepare for their doctor's visit. In particular, older patients have varying needs regarding the mode in which information is presented (eg, via textual, visual, or audiovisual modes) owing to age-related sensory (eg, impaired vision and hearing) and cognitive decline (eg, reduced processing speed). Therefore, Web-based information targeted at older patient populations is likely to be used and processed more effectively, and evaluated more positively, when tailored to age-related capabilities and preferences. This, in turn, may benefit patient outcomes. OBJECTIVE This randomized controlled trial tested the effects of a Web-based tailored educational intervention among newly diagnosed younger (<65 years) and older (≥65 years) patients with cancer. We compared the intervention group who viewed a mode-tailored website (ie, enabling patients to tailor information using textual, visual, and audiovisual modes) with 3 control groups view a nontailored website (ie, text only, text with images, and text with videos). We examined website experience outcomes (ie, website satisfaction, website involvement, knowledge, anxiety, and communication self-efficacy) and consultation experience outcomes (ie, question asking during consultation, anxiety, and information recall). METHODS Patients from a multidisciplinary outpatient clinic (N=232) viewed a mode-tailored or nontailored website as preparation before their hospital consultations to discuss diagnosis and treatment. Data were collected before (T1), during (T2), and after (T3) visitation. Website experience outcomes were assessed with questionnaires (T1). Patients' question asking was coded from videotaped consultations, and anxiety was assessed through a questionnaire (T2). Telephone interviews were conducted to assess knowledge acquired from the website before (T1) and after consultation (T3), and information recall from the consultation (T3). RESULTS The preparatory website was well used across all conditions (mean 34 min). Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only). This pattern was not found in older patients. Mode tailoring yielded no other significant differences in patient outcomes. Regression analyses showed that website involvement (beta=.15; P=.03) and, to a lesser extent, website satisfaction (beta=.15; P=.05) positively associated with knowledge before consultation (T1). In turn, higher knowledge before consultation (beta=.39; P<.001), together with time on the website (beta=.21; P=.002; T1), predicted information recall from consultations (T3). Patients with higher knowledge before consultation (T1) also reported higher knowledge from the website afterward (T3; beta=.22; P=.003). CONCLUSIONS Offering preparatory online information before consultations benefits information processing and patient outcomes of both younger and older newly diagnosed patients with cancer. Younger patients benefit even more when information is offered in a mode-tailored manner. We discuss the theoretical, methodological, and practical implications for patient-provider communication research in an electronic health era. CLINICAL TRIAL Netherlands Trial Register NTR5904; https://www.trialregister.nl/trial/5750.",2019,Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only).,"['Patients from a multidisciplinary outpatient clinic (N=232) viewed a', 'patients with cancer, including older patients (aged ≥65 years', 'Younger and Older Patients with Cancer', 'newly diagnosed younger (<65 years) and older (≥65 years) patients with cancer', 'younger and older newly diagnosed patients with cancer', 'older patients']","['Web-based tailored educational intervention', 'mode-tailored or nontailored website', 'intervention group who viewed a mode-tailored website (ie, enabling patients to tailor information using textual, visual, and audiovisual modes) with 3 control groups view a nontailored website (ie, text only, text with images, and text with videos', 'Preparatory Educational Intervention']","['website experience outcomes (ie, website satisfaction, website involvement, knowledge, anxiety, and communication self-efficacy) and consultation experience outcomes ', 'ie, question asking during consultation, anxiety, and information recall', 'website satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",,0.0749128,Younger patients viewing the mode-tailored website were more satisfied before consultation (P=.02) and reported lower anxiety after consultation (P=.046; vs text only).,"[{'ForeName': 'Minh Hao', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ellen Ma', 'Initials': 'EM', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bol', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eugène F', 'Initials': 'EF', 'LastName': 'Loos', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hanneke Wm', 'Initials': 'HW', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Debby', 'Initials': 'D', 'LastName': 'Geijsen', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Kristien Maj', 'Initials': 'KM', 'LastName': 'Tytgat', 'Affiliation': 'Department of Gastroenterology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Julia Cm', 'Initials': 'JC', 'LastName': 'van Weert', 'Affiliation': 'Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14407'] 1346,31579014,Diminishing Effects After Recurrent Use of Self-Guided Internet-Based Interventions in Depression: Randomized Controlled Trial.,"BACKGROUND Self-guided internet-based interventions have several advantages over guided interventions and are generally effective in treating psychiatric symptoms. OBJECTIVE We aimed to investigate whether the use of a new self-guided internet-based intervention (MOOD) would lead to a significant reduction in depressive symptoms compared with a care-as-usual (CAU) control group in a sample of individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial. METHODS A total of 125 individuals were randomized to the intervention condition (MOOD) and received access to the intervention for a period of six weeks or a CAU group. After six weeks, all participants were invited to take part in the post assessment. The Beck Depression Inventory-II served as the primary outcome. RESULTS Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD. Subsequent moderation analyses suggested that those individuals who had less experience with psychotherapy benefitted to a greater extent compared with those with more experience. CONCLUSIONS Self-guided internet-based interventions are deemed a suitable first-step approach to the treatment of depression. However, our results indicate that they are more efficacious in those with less psychotherapy experience. TRIAL REGISTRATION ClinicalTrials.gov NCT03795480; http://clinicaltrials.gov/ct2/show/NCT03795480.",2019,Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD.,"['individuals with depressive symptoms, most of whom had already used a different self-guided internet-based intervention in a previous trial', '125 individuals']","['Self-Guided Internet-Based Interventions', 'new self-guided internet-based intervention (MOOD']","['depressive symptoms', 'depressive symptomatology']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",125.0,0.164112,Both intention-to-treat as well as per-protocol analyses indicated that the depressive symptomatology decreased in both conditions but showed no advantage for those who had used MOOD.,"[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Bücker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Schnakenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Karyotaki', 'Affiliation': 'Department of Clinical Psychology, VU Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of medical Internet research,['10.2196/14240'] 1347,31592513,Cluster-randomized crossover trial of chlorhexidine-alcohol versus iodine-alcohol for prevention of surgical-site infection (SKINFECT trial).,"Background Surgical-site infection (SSI) is a serious surgical complication that can be prevented by preoperative skin disinfection. In Western European countries, preoperative disinfection is commonly performed with either chlorhexidine or iodine in an alcohol-based solution. This study aimed to investigate whether there is superiority of chlorhexidine-alcohol over iodine-alcohol for preventing SSI. Methods This prospective cluster-randomized crossover trial was conducted in five teaching hospitals. All patients who underwent breast, vascular, colorectal, gallbladder or orthopaedic surgery between July 2013 and June 2015 were included. SSI data were reported routinely to the Dutch National Nosocomial Surveillance Network (PREZIES). Participating hospitals were assigned randomly to perform preoperative skin disinfection using either chlorhexidine-alcohol (0·5 per cent/70 per cent) or iodine-alcohol (1 per cent/70 per cent) for the first 3 months of the study; every 3 months thereafter, they switched to using the other antiseptic agent, for a total of 2 years. The primary endpoint was the development of SSI. Results A total of 3665 patients were included; 1835 and 1830 of these patients received preoperative skin disinfection with chlorhexidine-alcohol or iodine-alcohol respectively. The overall incidence of SSI was 3·8 per cent among patients in the chlorhexidine-alcohol group and 4·0 per cent among those in the iodine-alcohol group (odds ratio 0·96, 95 per cent c.i. 0·69 to 1·35). Conclusion Preoperative skin disinfection with chlorhexidine-alcohol is similar to that for iodine-alcohol with respect to reducing the risk of developing an SSI.",2019,The overall incidence of SSI was 3·8 per cent among patients in the chlorhexidine-alcohol group and 4·0 per cent among those in the iodine-alcohol group,"['All patients who underwent breast, vascular, colorectal, gallbladder or orthopaedic surgery between July 2013 and June 2015 were included', 'Participating hospitals', 'A total of 3665 patients were included; 1835 and 1830 of these patients received', 'five teaching hospitals']","['preoperative skin disinfection using either chlorhexidine-alcohol (0·5 per cent/70 per cent) or iodine-alcohol', 'chlorhexidine-alcohol over iodine-alcohol', '\n\n\nSurgical-site infection (SSI', 'iodine-alcohol group', 'preoperative skin disinfection with chlorhexidine-alcohol or iodine-alcohol respectively', 'chlorhexidine or iodine', 'chlorhexidine-alcohol versus iodine-alcohol', 'chlorhexidine-alcohol']","['overall incidence of SSI', 'development of SSI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1698034', 'cui_str': 'Skin disinfection'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0243107', 'cui_str': 'development'}]",3665.0,0.0384158,The overall incidence of SSI was 3·8 per cent among patients in the chlorhexidine-alcohol group and 4·0 per cent among those in the iodine-alcohol group,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Charehbili', 'Affiliation': 'Department of Surgery Leiden University Medical Centre Leiden the Netherlands.'}, {'ForeName': 'M B G', 'Initials': 'MBG', 'LastName': 'Koek', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM) Bilthoven the Netherlands.'}, {'ForeName': 'J C A', 'Initials': 'JCA', 'LastName': 'de Mol van Otterloo', 'Affiliation': 'Department of Surgery Haaglanden Medical Centre The Hague the Netherlands.'}, {'ForeName': 'M W G A', 'Initials': 'MWGA', 'LastName': 'Bronkhorst', 'Affiliation': 'Department of Surgery Haaglanden Medical Centre The Hague the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van der Zwaal', 'Affiliation': 'Department of Orthopaedic Surgery Haaglanden Medical Centre The Hague the Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thomassen', 'Affiliation': 'Department of Orthopaedic Surgery Haaglanden Medical Centre The Hague the Netherlands.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Waasdorp', 'Affiliation': 'Groene Hart Ziekenhuis Gouda the Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Govaert', 'Affiliation': 'Groene Hart Ziekenhuis Gouda the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bosman', 'Affiliation': 'Alrijne Ziekenhuis Leiderdorp the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Bremer', 'Affiliation': 'Alrijne Ziekenhuis Leiderdorp the Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ploeg', 'Affiliation': 'Alrijne Ziekenhuis Leiderdorp the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics Leiden University Medical Centre Leiden the Netherlands.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Meijs', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM) Bilthoven the Netherlands.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery Leiden University Medical Centre Leiden the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'van Gijn', 'Affiliation': 'Department of Surgery Leiden University Medical Centre Leiden the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Swijnenburg', 'Affiliation': 'Department of Surgery Leiden University Medical Centre Leiden the Netherlands.'}]",BJS open,['10.1002/bjs5.50177'] 1348,29667488,Testing the Theory of Resilience and Relational Load (TRRL) in Families with Type I Diabetes.,"The theory of resilience and relational load was tested with 60 couples and their adolescent children (ages 11-18) with type I diabetes (T1D). The couples participated in a stress-inducing conversation task in their home, followed by a random assignment to a two-week intervention designed to increase their relationship maintenance. Before the intervention, stronger communal orientation predicted greater maintenance for husbands and wives, but maintenance only reduced T1D stress for wives. The wives' and adolescents' T1D stress were also correlated, but the husbands' T1D stress was not significantly associated with either of them. Better maintenance was associated with less conflict during couples' conversations. Maintenance was also directly associated with less perceived and physiological stress (cortisol) from the conversation. Finally, wives in the intervention reported the most thriving, communal orientation and the least loneliness. The intervention also reduced adolescents' general life stress, but it did not influence their T1D stress or thriving.",2019,"The intervention also reduced adolescents' general life stress, but it did not influence their T1D stress or thriving.","['families with type I diabetes', '60 couples and their adolescent children (ages 11-18) with type I diabetes (T1D']",['stress-inducing conversation task'],"[""husbands' T1D stress"", 'T1D stress', ""wives' and adolescents' T1D stress"", ""adolescents' general life stress""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0242664', 'cui_str': 'Husband (person)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",60.0,0.0142357,"The intervention also reduced adolescents' general life stress, but it did not influence their T1D stress or thriving.","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Afifi', 'Affiliation': 'a Department of Communication, University of California Santa Barbara , Santa Barbara , CA , USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Granger', 'Affiliation': 'b Department of Psychology and Social Behavior, Pediatrics, and Program in Public Health, University of California , Irvine , CA , USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ersig', 'Affiliation': 'c University of Wisconsin-Madison School of Nursing , Madison , WI , USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Tsalikian', 'Affiliation': 'e University of Iowa Hospitals , Iowa City , IA , USA.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Shahnazi', 'Affiliation': 'f Department of Communication Studies, University of Iowa , Iowa City , IA , USA.'}, {'ForeName': 'Sharde', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'g Department of Communication, University of Connecticut , Storrs , CT , USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'a Department of Communication, University of California Santa Barbara , Santa Barbara , CA , USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Acevedo Callejas', 'Affiliation': 'f Department of Communication Studies, University of Iowa , Iowa City , IA , USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Scranton', 'Affiliation': 'f Department of Communication Studies, University of Iowa , Iowa City , IA , USA.'}]",Health communication,['10.1080/10410236.2018.1461585'] 1349,31473600,Oxygen Therapy in Myocardial Infarction Patients With or Without Diabetes: A Predefined Subgroup Analysis From the DETO2X-AMI Trial.,"OBJECTIVE To determine the effects of oxygen therapy in myocardial infarction (MI) patients with and without diabetes. RESEARCH DESIGN AND METHODS In the Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis involving 5,010 patients with confirmed MI, 934 had known diabetes. Oxidative stress may be of particular importance in diabetes, and the primary objective was to study the effect of supplemental oxygen on the composite of all-cause death and rehospitalization with MI or heart failure (HF) at 1 year in patients with and without diabetes. RESULTS As expected, event rates were significantly higher in patients with diabetes compared with patients without diabetes (main composite end point: hazard ratio [HR] 1.60 [95% CI 1.32-1.93], P < 0.01). In patients with diabetes, the main composite end point occurred in 16.2% (72 of 445) allocated to oxygen as compared with 16.6% (81 of 489) allocated to ambient air (HR 0.93 [95% CI 0.67-1.27], P = 0.81). There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year. Likewise, corresponding end points in patients without diabetes were similar between the treatment groups. CONCLUSIONS Despite markedly higher event rates in patients with MI and diabetes, oxygen therapy did not significantly affect 1-year all-cause death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes, in line with the results of the entire study.",2019,There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year.,"['5,010 patients with confirmed MI, 934 had known diabetes', '6,629 normoxemic patients with suspected MI', 'patients with and without diabetes', 'myocardial infarction (MI) patients with and without diabetes', 'Myocardial Infarction Patients With or Without Diabetes']","['oxygen therapy', 'Oxygen Therapy']","['rate of cardiovascular death', 'death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes', 'event rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5010.0,0.135599,There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyström', 'Affiliation': 'Division of Endocrinology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Cardiology, Department of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Herlitz', 'Affiliation': 'Department of Health Sciences, University of Borås, Borås, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mellbin', 'Affiliation': 'Division of Cardiology, Department of Medicine, Solna, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Cardiology, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0590'] 1350,31542640,Influence of sex on chemotherapy efficacy and toxicity in oesophagogastric cancer: A pooled analysis of four randomised trials.,"BACKGROUND Sex contributes to interpatient variability of chemotherapy metabolism and dose response, potentially influencing both efficacy and toxicity; however, comparative data on its effect on oesophagogastric cancer are lacking. PATIENTS AND METHODS Data for patients with advanced oesophagogastric cancer randomised to comparable first-line chemotherapy regimens within four United Kingdom prospective trials were pooled, and key demographic and outcome measures were compared between males and females. RESULTS A total of 1654 patients were included: 1328 (80.3%) males and 326 (19.7%) females. Female patients were younger, had a significantly higher proportion of gastric tumours as opposed to junctional or oesophageal tumours and experienced significantly higher rates of a number of toxicities including nausea and vomiting, diarrhoea, stomatitis and alopecia. When adjusting for potential confounding factors, the risk of female patients experiencing grade ≥III gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12). Females also had a significantly higher incidence of serious adverse events on treatment and received comparatively less cycles of chemotherapy overall than males. CONCLUSIONS This represents the largest pooled analysis of the effect of sex on chemotherapy outcome and toxicity in advanced oesophagogastric cancer. The differential toxicity and adverse event rates observed suggest that sex may be an important modulator of treatment tolerability and safety in this tumour type.",2019,gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12).,"['A total of 1654 patients were included: 1328 (80.3%) males and 326 (19.7%) females', 'advanced oesophagogastric cancer', 'oesophagogastric cancer', 'patients with advanced oesophagogastric cancer', 'female patients experiencing grade ≥III']",[],"['proportion of gastric tumours', 'gastrointestinal toxicity', 'toxicities including nausea and vomiting, diarrhoea, stomatitis and alopecia', 'serious adverse events', 'chemotherapy efficacy and toxicity']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",1654.0,0.125896,gastrointestinal toxicity was greater (adjusted odds ratio = 1.50; 95% confidence interval = 1.07-2.12).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Anna Dorothea', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Universitaire Vaudois, Switzerland.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Kouvelakis', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Nanji', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal Research Unit, Royal Marsden Hospitals NHS Foundation Trust, London, UK. Electronic address: david.cunningham@rmh.nhs.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.08.010'] 1351,31629030,"18-month clinical evaluation of a copper-containing universal adhesive in non-carious cervical lesions: A double-blind, randomized controlled trial.","OBJECTIVE This study aimed to evaluate the addition of copper nanoparticles (CuNp) on the clinical performance of a universal adhesive system used as etch-and-rinse (ER) and self-etch (SE). METHODS 216 restorations were randomly placed in 36 subjects according to the following groups: ERcu = etch-and-rinse with 0.1% CuNp; ERct = etch-and-rinse without CuNp; SEcu = self-etch with 0.1% CuNp; SEct = self-etch without CuNp. Resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline and 6, 12 and 18 months using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (α = 0.05). RESULTS The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05). The addition of CuNp in SE restorations increased the retention rate significantly and decreased the marginal discrepancies after 18 months (p < 0.05). CONCLUSION The clinical performance of universal adhesive was significantly increased when applied in the SE mode with the addition of copper nanoparticles. CLINICAL RELEVANCE This is the first study that demonstrates a slight improvement in the clinical performance of universal adhesive systems in non-carious cervical lesions when added CuNp in lower concentration.",2019,The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05).,"['non-carious cervical lesions', '216 restorations were randomly placed in 36 subjects according to the following groups']","['etch-and-rinse (ER) and self-etch (SE', 'ERcu = etch-and-rinse with 0.1% CuNp; ERct = etch-and-rinse without CuNp; SEcu = self-etch with 0.1% CuNp; SEct = self-etch without CuNp. Resin composite was placed incrementally and light-cured', 'copper nanoparticles (CuNp', 'copper-containing universal adhesive']","['retention rate', 'clinical performance of universal adhesive', 'clinical performance (FDI / USPHS', 'marginal discrepancies']","[{'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",36.0,0.110542,The addition of CuNp did not increase the clinical performance (FDI / USPHS) of the universal adhesive tested after 18-month when applied in the ER mode (p > 0.05).,"[{'ForeName': 'Thalita P', 'Initials': 'TP', 'LastName': 'Matos', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Gutiérrez', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil; Institute for Research in Dental Sciences, Faculty of Dentistry, University of Chile, Santiago, Chile; Faculty of Dentistry, Finis Terrae University, Santiago, Chile.'}, {'ForeName': 'Taise A', 'Initials': 'TA', 'LastName': 'Hanzen', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Pâmela', 'Initials': 'P', 'LastName': 'Malaquias', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'de Paula', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Jullian J', 'Initials': 'JJ', 'LastName': 'de Souza', 'Affiliation': 'School of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Hass', 'Affiliation': 'Postgraduate Program in Dentistry, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fernández', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Chile, Santiago, Chile; Instituto de Ciencias Biomédicas, Universidad Autónoma de Chile, Providencia, Chile.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil. Electronic address: aloguercio@hotmail.com.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103219'] 1352,31623819,Low-fat diet after cholecystectomy: Should it be systematically recommended?,"INTRODUCTION Even though evidence is lacking, a low-fat diet has been traditionally recommended after cholecystectomy. The main aim of this study was to assess the potential correlation between postoperative symptoms and type of diet after cholecystectomy. METHODS Symptoms were prospectively assessed by the Gastrointestinal Quality of Life Index (GIQLI) score at baseline, one month and 6 months after cholecystectomy in 83 patients operated on at our institution. Patients completed a questionnaire about their diet and were classified into 4 groups according to the amount of fat intake. Differences in the GIQLI score depending on the type of diet were assessed over time. RESULTS The overall GIQLI score and most subdomains significantly increased after surgery compared to baseline, regardless of the intake of dietary fat. Constipation improved after cholecystectomy compared to baseline, whereas diarrhea and bowel urgency got worse. More than 50% of patients experienced a change in their bowel habit after surgery, which persisted 6 months later in 23% of cases. CONCLUSIONS A low fat diet does not seem to have an influence on the improvement of symptoms after cholecystectomy. However, a randomized study is ongoing at our institution to confirm the results of this prospective study.",2020,"The overall GIQLI score and most subdomains significantly increased after surgery compared to baseline, regardless of the intake of dietary fat.",['83 patients operated on at our institution'],['Low-fat diet after cholecystectomy'],"['overall GIQLI score', 'GIQLI score', 'Constipation', 'diarrhea and bowel urgency', 'Gastrointestinal Quality of Life Index (GIQLI) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}]",83.0,0.0158013,"The overall GIQLI score and most subdomains significantly increased after surgery compared to baseline, regardless of the intake of dietary fat.","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ribas Blasco', 'Affiliation': 'Servicio de Cirugía General y Digestiva, Consorci Sanitari de Terrassa, Terrassa, Barcelona, España.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Pérez Muñante', 'Affiliation': 'Servicio de Cirugía General y Digestiva, Consorci Sanitari de Terrassa, Terrassa, Barcelona, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gómez-Fernández', 'Affiliation': 'Servicio de Cirugía General y Digestiva, Consorci Sanitari de Terrassa, Terrassa, Barcelona, España.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Jovell-Fernández', 'Affiliation': 'Servicio de Epidemiología, Consorci Sanitari de Terrassa, Terrassa, Barcelona, España.'}, {'ForeName': 'Luís María', 'Initials': 'LM', 'LastName': 'Oms Bernad', 'Affiliation': 'Servicio de Cirugía General y Digestiva, Consorci Sanitari de Terrassa, Terrassa, Barcelona, España. Electronic address: loms@cst.cat.'}]",Cirugia espanola,['10.1016/j.ciresp.2019.05.009'] 1353,29869014,Minimally invasive versus open chevron osteotomy for hallux valgus correction: a randomized controlled trial.,"PURPOSE The purpose of this study was to compare a minimally invasive chevron osteotomy technique (MIS group) and the well-established open chevron technique (OC group) for correction of hallux valgus deformity. METHODS Patients who were scheduled to undergo a hallux valgus surgery by means of a distal chevron osteotomy were randomly assigned to one of the two groups. Pre-operatively, six weeks, 12 weeks, and nine months post-operatively the following outcome parameters were determined: Visual Analog Scores (VAS) of pain, the American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, radiographic outcome measures, range of motion (ROM), and patient satisfaction. RESULTS Forty-seven cases were analyzed (25 MIS group; 22 OC group). Both operative techniques achieved significant correction of the hallux deformity. The intermetatarsal angle (IMA) improved from 15.1° to 5.8° in the OC and from 14° to 6.8°in the MIS group, whereas the hallux valgus angle (HVA) improved from 28.3° to 8.5° in the OC versus 26.4° to 6.9° in the MIS group. No significant differences were observed between the groups by any of the determined outcome parameters. Regarding patient satisfaction, statistically significant differences were found between MIS and open surgery 12 weeks post-operatively in favour of the MIS group (p = 0.022). CONCLUSION With the minimally invasive chevron osteotomy, radiological and clinical outcome is comparable to the open technique.",2019,"Regarding patient satisfaction, statistically significant differences were found between MIS and open surgery 12 weeks post-operatively in favour of the MIS group (p = 0.022). ","['hallux valgus correction', 'Patients who were scheduled to undergo a hallux valgus surgery by means of a distal chevron osteotomy']","['Minimally invasive versus open chevron osteotomy', 'minimally invasive chevron osteotomy technique (MIS group) and the well-established open chevron technique (OC group']","['hallux valgus angle (HVA', 'Visual Analog Scores (VAS) of pain, the American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, radiographic outcome measures, range of motion (ROM), and patient satisfaction', 'intermetatarsal angle (IMA']","[{'cui': 'C0856213', 'cui_str': 'Hallux Valgus correction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0158458', 'cui_str': 'Acquired hallux valgus (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C3163986', 'cui_str': 'Chevron osteotomy (procedure)'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3163986', 'cui_str': 'Chevron osteotomy (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0443173', 'cui_str': 'Chevron (qualifier value)'}]","[{'cui': 'C0158458', 'cui_str': 'Acquired hallux valgus (disorder)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",47.0,0.0258737,"Regarding patient satisfaction, statistically significant differences were found between MIS and open surgery 12 weeks post-operatively in favour of the MIS group (p = 0.022). ","[{'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Kaufmann', 'Affiliation': 'Orthopaedic and Foot Center Innsbruck (OFZ Innsbruck), Innrain 2, 6020, Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Dammerer', 'Affiliation': 'Orthopaedic Department of the Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. dietmar.dammerer@tirol-kliniken.at.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Heyenbrock', 'Affiliation': 'Orthopaedic Department of the Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Braito', 'Affiliation': 'Orthopaedic Department of the Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Moertlbauer', 'Affiliation': 'Orthopaedic Department of the Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liebensteiner', 'Affiliation': 'Orthopaedic Department of the Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}]",International orthopaedics,['10.1007/s00264-018-4006-8'] 1354,31638594,The Effect of an App for Day-to-Day Postoperative Care Education on Patients With Total Knee Replacement: Randomized Controlled Trial.,"BACKGROUND Patients who undergo primary Total Knee Replacement surgery (TKR) are often discharged within 1-3 days after surgery. With this relatively short length of hospital stay, a patient's self-management is a crucial factor in optimizing the outcome of their treatment. In the case of TKR, self-management primarily involves adequate pain management, followed by physiotherapy exercises and daily self-care activities. Patients are educated on all these topics by hospital staff upon discharge from the hospital but often struggle to comprehend this information due to its quantity, complexity, and the passive mode of communication used to convey it. OBJECTIVE This study primarily aims to determine whether actively educating TKR patients with timely, day-to-day postoperative care information through an app could lead to a decrease in their level of pain compared to those who only receive standard information about their recovery through the app. In addition, physical functioning, quality of life, ability to perform physiotherapy exercises and daily self-care activities, satisfaction with information, perceived involvement by the hospital, and health care consumption were also assessed. METHODS A multicenter randomized controlled trial was performed in five Dutch hospitals. In total, 213 patients who had undergone elective, primary, unilateral TKR participated. All patients had access to an app for their smartphone and tablet to guide them after discharge. The intervention group could unlock day-to-day information by entering a personal code. The control group only received weekly, basic information. Primary (level of pain) and secondary outcomes (physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption) were measured using self-reported online questionnaires. All outcomes were measured weekly in the four weeks after discharge, except for physical functioning and quality of life, which were measured at baseline and at four weeks after discharge. Data was analyzed using Student t tests, chi-square tests, and linear mixed models for repeated measures. RESULTS In total, 114 patients were enrolled in the intervention group (IG) and 99 in the control group (CG). Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain: pain at rest (mean 3.45 vs mean 4.59; P=.001), pain during activity (mean 3.99 vs mean 5.08; P<.001) and pain at night (mean 4.18 vs mean 5.21; P=.003). Additionally, significant differences were demonstrated in favor of the intervention group for all secondary outcomes. CONCLUSIONS In the four weeks following TKR, the active and day-to-day education of patients via the app significantly decreased their level of pain and improved their physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption compared to standard patient education. Given the rising number of TKR patients and the increased emphasis on self-management, we suggest using an app with timely postoperative care education as a standard part of care. TRIAL REGISTRATION Netherlands Trial Register NTR7182; https://www.trialregister.nl/trial/6992.",2019,"Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain:","['114 patients were enrolled in the intervention group (IG) and 99 in the control group (CG', '213 patients who had undergone elective, primary, unilateral TKR participated', 'five Dutch hospitals', 'Patients who undergo primary Total Knee Replacement surgery (TKR', 'Patients With Total Knee Replacement']","['App for Day-to-Day Postoperative Care Education', 'CG']","['pain at rest', 'physical functioning, quality of life, ability to perform physiotherapy exercises and daily self-care activities, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'pain at night', 'pain', 'Primary (level of pain) and secondary outcomes (physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'level of pain and improved their physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'physical functioning and quality of life', 'pain during activity']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",213.0,0.109026,"Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain:","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Timmers', 'Affiliation': 'Interactive Studios, Rosmalen, Netherlands.'}, {'ForeName': 'Loes', 'Initials': 'L', 'LastName': 'Janssen', 'Affiliation': 'Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'van der Weegen', 'Affiliation': 'Sint Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': 'Sint Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Willem-Jan', 'Initials': 'WJ', 'LastName': 'Marijnissen', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerjon', 'Initials': 'G', 'LastName': 'Hannink', 'Affiliation': 'Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Babette C', 'Initials': 'BC', 'LastName': 'van der Zwaard', 'Affiliation': ""Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Plat', 'Affiliation': ""Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Thomassen', 'Affiliation': ""Haaglanden Medical Center, 's-Gravenhage, Netherlands.""}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'Swen', 'Affiliation': ""Haaglanden Medical Center, 's-Gravenhage, Netherlands.""}, {'ForeName': 'Rudolf B', 'Initials': 'RB', 'LastName': 'Kool', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, Netherlands.'}, {'ForeName': 'Frederik Okke', 'Initials': 'FO', 'LastName': 'Lambers Heerspink', 'Affiliation': 'VieCuri Medical Centre, Venlo, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/15323'] 1355,31876772,Pain Perception of a Structured Vascular Access Team Approach to Short Peripheral Catheter (SPC) Placement Compared to SPC Placement by Bedside Nurses.,"This study investigates the use of a structured protocol by vascular access team (VAT) nurses compared with the practice of bedside nurses to minimize patient pain related to short peripheral catheter (SPC) insertion. During this quantitative study, 201 adults were randomly assigned to have their SPC placed either by the VAT or by bedside nurses. Results showed significantly lower pain scores with the VAT SPC placement (P = .026), and patients were significantly more likely to report the experience as better than their previous SPC placement experiences (χ = 7.8; P = .005). Therefore, the use of a VAT would be worthwhile to improve patient satisfaction.",2020,"Results showed significantly lower pain scores with the VAT SPC placement (P = .026), and patients were significantly more likely to report the experience as better than their previous SPC placement experiences (χ = 7.8; P = .005).",['201 adults'],"['SPC placed either by the VAT or by bedside nurses', 'VAT', 'Short Peripheral Catheter (SPC) Placement', 'short peripheral catheter (SPC) insertion', 'structured protocol by vascular access team (VAT) nurses']","['Pain Perception', 'pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1827740', 'cui_str': 'Peripheral catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",201.0,0.0509242,"Results showed significantly lower pain scores with the VAT SPC placement (P = .026), and patients were significantly more likely to report the experience as better than their previous SPC placement experiences (χ = 7.8; P = .005).","[{'ForeName': 'Genichiro', 'Initials': 'G', 'LastName': 'Fujioka', 'Affiliation': 'Parkland Memorial Hospital, Dallas, Texas (Mr Fujioka); Texas Health Resources, Arlington, Texas (Dr Newcomb); Texas Health Harris Methodist Hospital, Fort Worth, Texas (Mss Myers and Hunchusky); College of Nursing at The University of Texas at Arlington and Texas Health HEB Hospital, Bedford, Texas (Dr Behan). Genichiro Fujioka, BSN, RN, is a critical care and trauma nurse intern at Parkland Hospital. He received a BSN degree from The University of Texas at Arlington. Patricia Newcomb, PhD, RN, CPNPRet, serves as a nurse scientist for Texas Health Resources in Arlington, Texas. Previous experience includes academic appointments at University of Texas at Arlington and Texas Christian University; postdoctoral research at University of California, San Francisco; and clinical service as an advanced practice nurse. Cindy Hunchusky, BSN, RN, CRNI®, is a member of the vascular access/PICC team at Texas Health Harris Methodist Hospital. She received a BSN degree from Tarleton State University and has been a CRNI® since 2008. She has experience in infusion therapy home care, infusion clinics, and infectious disease practice. Helen Myers, BSN, RN, CRNI®, is a member of the vascular access/PICC team at Texas Health Harris Methodist Hospital Fort Worth. She received a BSN degree from Texas Christian University in 2001 and has been a CRNI® since 2008. She has experience in postanesthesia care, catheterizations, and angiograms in the hospital. Deborah Behan, PhD, RN-BC, is a clinical associate professor at the College of Nursing at The University of Texas at Arlington. Dr Behan is the honors coordinator for the College of Nursing BSN students and the nurse scientist at Texas Health HEB hospital, where she works on research with nurses.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Newcomb', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hunchusky', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Behan', 'Affiliation': ''}]",Journal of infusion nursing : the official publication of the Infusion Nurses Society,['10.1097/NAN.0000000000000352'] 1356,29426811,Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy for keloid treatment: Randomised controlled trials.,"BACKGROUND Keloids are a burden for patients due to physical, aesthetic and social consequences. Treatment remains a challenge due to therapy resistance and high recurrence rates. The main goals of treatment are to improve scar appearance and symptoms and patients' quality of life (QoL). METHODS Two multicentre, randomised controlled open trials that compared 1) intralesional cryotherapy with excision and corticosteroid injections for primary keloids, and 2) intralesional cryotherapy with excision and brachytherapy for therapy resistant keloids. Primary outcome was scar appearance assessed with the Patient and Observer Scar Assessment Scale. Secondary outcomes were patient reported QoL (Skindex-29, SF-36, EQ-5D-5L), recurrence rates and scar volume reduction. For analysis, a linear mixed model was used. Power analysis indicated 33 patients in each group were needed. RESULTS The trial was prematurely terminated after inclusion of 26 patients due to unexpectedly inferior outcomes after intralesional cryotherapy. For primary keloids no convincing difference between treatments was found, but surgery improved scar appearance while cryotherapy did not. For resistant keloids, excision followed by brachytherapy improved scar appearance (POSAS) and scar symptoms (itch and pain) significantly (p < 0.001, p < 0.001 and p = 0.006 respectively) while cryotherapy did not. Neither of the treatments caused indisputable improvements in QoL. CONCLUSIONS Intralesional cryotherapy is inferior to keloid excision followed by brachytherapy for resistant keloids. In primary keloids, intralesional cryotherapy reduced keloid volume and, therefore, may be used in these patients and specific cases. Primary keloid group size was too small to draw valid conclusions, further research on the efficacy of intralesional cryotherapy for primary keloids is warranted.",2018,"Neither of the treatments caused indisputable improvements in QoL. CONCLUSIONS Intralesional cryotherapy is inferior to keloid excision followed by brachytherapy for resistant keloids.",['keloid treatment'],"['Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy', 'intralesional cryotherapy with excision and corticosteroid injections for primary keloids, and 2) intralesional cryotherapy with excision and brachytherapy', 'intralesional cryotherapy']","['scar appearance', 'keloid volume', 'patient reported QoL (Skindex-29, SF-36, EQ-5D-5L), recurrence rates and scar volume reduction', ""scar appearance and symptoms and patients' quality of life (QoL"", 'scar appearance (POSAS) and scar symptoms (itch and pain', 'scar appearance assessed with the Patient and Observer Scar Assessment Scale']","[{'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",33.0,0.0484999,"Neither of the treatments caused indisputable improvements in QoL. CONCLUSIONS Intralesional cryotherapy is inferior to keloid excision followed by brachytherapy for resistant keloids.","[{'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Bijlard', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands. Electronic address: e.bijlard@erasmusmc.nl.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Unit of Medical Psychology and Psychotherapy, Erasmus MC, University Medical Centre Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Gerda M', 'Initials': 'GM', 'LastName': 'Verduijn', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Niessen', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, VU University Medical Centre, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Steven E R', 'Initials': 'SER', 'LastName': 'Hovius', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands; Hand and Wrist Surgery, Xpert Clinic, Jan Leentvaarlaan 14-24, 3065 DC Rotterdam, The Netherlands.'}, {'ForeName': 'Marc A M', 'Initials': 'MAM', 'LastName': 'Mureau', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2018.01.033'] 1357,31633261,Baseline functional connectivity may predict placebo responses to accelerated rTMS treatment in major depression.,"Although in theory sham repetitive transcranial magnetic stimulation (rTMS) has no inherent therapeutic value, nonetheless, such placebo stimulations may have relevant therapeutic effects in clinically depressed patients. On the other hand, antidepressant responses to sham rTMS are quite heterogeneous across individuals and its neural underpinnings have not been explored yet. The current brain imaging study aims to detect baseline neural fingerprints resulting in clinically beneficial placebo rTMS treatment responses. We collected resting-state functional magnetic resonance imaging data prior to a registered randomized clinical trial of accelerated placebo stimulation protocol in patients documented with treatment-resistant depression (http://clinicaltrials.gov/show/NCT01832805). In addition to global brain connectivity and rostral anterior cingulate cortex (rACC) seed-based functional connectivity (FC), elastic-net regression and cross-validation procedures were used to identify baseline intrinsic brain connectivity biomarkers for sham-rTMS responses. Placebo responses to accelerated sham rTMS were correlated with baseline global brain connectivity in the rACC/ventral medial prefrontal cortex (vmPFC). Concerning the rACC seed-based FC analysis, the placebo response was associated positively with the precuneus/posterior cingulate (PCun/PCC) cortex and negatively with the middle frontal gyrus. Our findings provide first brain imaging evidence for placebo responses to sham stimulation being predictable from rACC rsFC profiles, especially in brain areas implicated in (re)appraisal and self-focus processes.",2020,Placebo responses to accelerated sham rTMS were correlated with baseline global brain connectivity in the rACC/ventral medial prefrontal cortex (vmPFC).,"['clinically depressed patients', 'major depression', 'patients documented with treatment-resistant depression (http://clinicaltrials.gov/show/NCT01832805']","['placebo', 'Placebo', 'accelerated placebo stimulation protocol', 'repetitive transcranial magnetic stimulation (rTMS']",['baseline global brain connectivity'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",,0.332203,Placebo responses to accelerated sham rTMS were correlated with baseline global brain connectivity in the rACC/ventral medial prefrontal cortex (vmPFC).,"[{'ForeName': 'Guo-Rong', 'Initials': 'GR', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Xiaowan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Ghent University, Ghent, Belgium.'}]",Human brain mapping,['10.1002/hbm.24828'] 1358,29428925,Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer for Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation.,"Context Global morbidity from chronic obstructive pulmonary disease (COPD) is high worldwide. Diaphragm pacing (DP) can maintain the natural, negative pressure breathing of COPD patients with diaphragmatic muscle dysfunction. The YiqiDitanTongfu (YDTF) decoction has been used clinically with COPD patients to help them to wean from mechanical ventilation, with their ventilation functions being improved and the success rate of weaning being largely increased. Objective The study intended to investigate the combined therapeutic effects of external DP and the YDTF decoction for COPD patients who have had difficulty weaning from mechanical ventilation. Design This study was a retrospective cohort study. Setting The study occurred at the Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China). Participants Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage. Intervention The participants were randomly divided into 3 groups: (1) traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group). All treatments occurred for 12 d. Outcome Measures Relevant outcomes were measured and compared at baseline and postintervention, including the rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation. Results The patients treated with the DP plus the YDTF decoction were more successful in weaning from mechanical ventilation than those treated with DP. Of the patients with COPD + type 1 respiratory failure, 86.67% succeeded vs 70.00% of the DP patients. Of patients with COPD + type 2 respiratory failure, 87.88% succeeded vs 79.41% of the DP patients. Conclusion The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.",2020,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","['Chronic Obstructive Pulmonary Disease Patients With Difficulty Weaning From Mechanical Ventilation', 'Hebei General Hospital and Hebei Province Chest Hospital (Hebei Province, Shijiazhuang, China', 'Participants were 90 patients with COPD + type 1 respiratory failure, 101 patients with COPD + Type 2 respiratory failure, and 96 patients with COPD at the compensated stage', 'Participants •', 'COPD patients who have had difficulty weaning from mechanical ventilation', 'COPD patients with diaphragmatic muscle dysfunction', 'chronic obstructive pulmonary disease (COPD']","['Adjuvant Therapy: YiqiDitanTongfu Decoction With External Diaphragm Pacer', 'Diaphragm pacing (DP', 'YDTF decoction', 'external DP and the YDTF decoction', 'traditional treatment (control group), (2) traditional treatment plus treatment with a diaphragm pacemaker (DP group), and (3) traditional treatment plus treatment with a DP and a YDTF decoction (DP + YDTF group', 'YiqiDitanTongfu (YDTF) decoction']","['Global morbidity', 'rapid shallow breathing index, tidal volume, maximum inspiratory pressure, degree of diaphragmatic muscle activity, maximum expiratory pressure, the successful rates of weaning from mechanical ventilation, the potential of hydrogen, the partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia (disorder)'}, {'cui': 'C0398353', 'cui_str': 'Type II respiratory failure'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C1301400', 'cui_str': 'Diaphragm pacing'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0425488', 'cui_str': 'Rapid shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0232022', 'cui_str': 'Maximum expiratory pressure (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",101.0,0.0352537,"The DP plus the YDTF concoction acted as a successful treatment for heart failure caused by CPOD in comparison with the DP or YDTF alone, providing evidence that the DP + YDTF concoction can serve as a competitive method for helping COPD patients to wean from mechanical ventilation.","[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Quansheng', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Heling', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Xianlei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 1359,31600429,A Pilot Randomized Controlled Trial for Aerobic and Strengthening Exercises on Physical Function and Pain for Hip Osteoarthritis.,"BACKGROUND Hip osteoarthritis (OA) limits lower extremity physical function. Exercise therapy may improve physical function and reduce pain in patients with hip OA. OBJECTIVE To evaluate the feasibility of a randomized controlled trial (RCT) to measure the effect of a structured hip-specific resistance and aerobic exercise program on physical function and self-reported pain in adults with hip OA. DESIGN Pilot RCT. SETTING Academic medical center. PARTICIPANTS Thirty one adults with radiographic hip OA. INTERVENTIONS Participants were randomly allocated in a 2:1 ratio to a 3-month structured exercise intervention (n = 21) or a 3-month waitlist control (n = 10). MAIN OUTCOME MEASURES The 6-minute walk test was the primary outcome measure. Self-reported physical function was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale and pain visual analog scale (VAS). Measures of feasibility were assessed as secondary outcomes. RESULTS From baseline to 3 months, the median change from baseline in distance covered during the 6-minute walk test in the intervention group (49 m) was double that of the control group (22 m), but the difference was not statistically significant (P = .13). Likewise, the WOMAC physical function subscale score median changes in the intervention group (5 points) were double that of the controls (2 points), although the difference was not statistically significant (P = .06). Median change in pain scores was slightly reduced in each group but not significantly different between groups (P = .53). CONCLUSION Although no statistically significant between-group differences were found in this pilot RCT, improvements were seen in measures of physical function compared to controls. A larger RCT of this structured exercise program may be warranted.",2020,"Although no statistically significant between-group differences were found in this pilot RCT, improvements were seen in measures of physical function compared to controls.","['Hip Osteoarthritis', ' 31 adults with radiographic hip OA', 'adults with hip OA', 'patients with hip OA']","['Aerobic and Strengthening Exercises', 'structured exercise intervention (n=21) or a 3-month wait-list control', 'structured hip-specific resistance and aerobic exercise program', 'Exercise therapy']","['physical function and self-reported pain', 'physical function', 'Median change in pain scores', 'WOMAC physical function subscale score median changes', 'Physical Function and Pain', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale and pain visual analog scale (VAS', 'physical function and reduce pain']","[{'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",31.0,0.0948961,"Although no statistically significant between-group differences were found in this pilot RCT, improvements were seen in measures of physical function compared to controls.","[{'ForeName': 'Austin R', 'Initials': 'AR', 'LastName': 'Thompson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Christopherson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Marshall', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Carlson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Nels L', 'Initials': 'NL', 'LastName': 'Carlson', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12262'] 1360,31619357,Macular Atrophy in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial Comparing Ranibizumab and Aflibercept (RIVAL Study).,"PURPOSE To investigate differences in the development of macular atrophy (MA) over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in patients with neovascular age-related macular degeneration (nAMD). DESIGN A phase 4 randomized, partially masked, multicenter study. PARTICIPANTS Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more. METHODS Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading center-guided T&E regimen after 3 initial monthly injections. MAIN OUTCOME MEASURES The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24. RESULTS Two hundred seventy-eight patients were included in the analysis (ranibizumab 0.5 mg, n = 141; aflibercept 2.0 mg, n = 137). Mean change in square root area of MA from baseline to month 24 was +0.36 mm (95% confidence interval [CI], 0.27-0.45 mm) for ranibizumab and +0.28 mm (95% CI, 0.19-0.37 mm) for aflibercept (treatment difference, +0.08 mm [95% CI, -0.05 to 0.21 mm]; P = 0.24). The proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for ranibizumab and from 6% (8/137) to 32% (35/108) for aflibercept from baseline to month 24. The average number of injections received per year was similar between both groups: 9.6 (95% CI, 9.2-10.0) for ranibizumab and 9.5 (95% CI, 9.1-9.9) for aflibercept. The mean change in BCVA from baseline to month 24 was +6.6 letters (95% CI,4.7-8.5 letters) for the ranibizumab group and +4.6 letters (95% CI, 2.7-6.6 letters) for the aflibercept group ( P = 0.15). Rates of adverse events (AEs) were similar between both groups. CONCLUSIONS No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.",2020,No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.,"['patients with neovascular age-related macular degeneration (nAMD', 'Patients', 'Neovascular Age-Related Macular Degeneration', 'Two hundred seventy-eight patients were included in the analysis ', 'Individuals 50 years of age or older diagnosed with active, treatment-naïve subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more']","['ranibizumab', 'treat-and-extend (T&E) ranibizumab and aflibercept', 'Ranibizumab and Aflibercept', 'ranibizumab and aflibercept', 'intravitreal injections of ranibizumab 0.5 mg or aflibercept']","['mean change in square root area of MA', 'proportion of patients with MA', 'Mean change in square root area of MA', 'rate of development or growth of MA', 'average number of injections received per year', 'mean change in BCVA', 'number of injections and mean change in BCVA', 'Rates of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",278.0,0.510127,No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Gillies', 'Affiliation': 'Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hunyor', 'Affiliation': 'Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia; Retina Associates, Chatswood, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Specialists, Parramatta, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Francois L', 'Initials': 'FL', 'LastName': 'Pecheur', 'Affiliation': 'Healthcare Professionals Group Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Marion R', 'Initials': 'MR', 'LastName': 'Munk', 'Affiliation': 'Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'McAllister', 'Affiliation': 'Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.023'] 1361,31617395,The effect of a home exercise intervention on persons with lower limb amputations: a randomized controlled trial.,"OBJECTIVE To establish if a home-based exercise and education programme is more effective than usual treatment in improving function, mobility and quality of life in people with lower limb amputation due to peripheral vascular disease. METHOD A blocked randomized single-blinded controlled trial (RCT) with 154 participants (54 female; mean age 58) compared a home-based exercise and education programme (n = 77) with usual care (control) (n = 77). Participants were measured at baseline, immediately post intervention at three months, and after a further three months without any intervention. The outcome measures were the Barthel Index, Participation Scale, EuroQuol 5D, Modified Locomotor Capability Index and Timed Up and Go Test. Changes over time were established using generalized estimating equations and analysis of covariance, ( P  < 0.05). RESULTS The Participation Scale (18.73 ± 14.91 against 26.67 ± 19.14; P  = 0.011), the EuroQuol5D visual analogue scale (69.10 ± 20.31 against 55.37 ± 27.67; P  = 0.003), EuroQuol5D utility index (0.672 ± 0.300 against 0.532 ± 0.358; P  = 0.25) and the Modified Capability Index (21.03 ± 15.79 against 15.91 ± 13.67; P  = 0.034) improved in the intervention group compared with the control group at three months. At six months, there was no difference between the groups in any of the measures except for the EuroQuol5D visual analogue scale (74.52 ± 16.14 against 66.34 ± 22.91; P  = 0.033). Although there were no differences between the Timed Up and Go test at 3 (35.39 ± 32.48 against 45.08 ± 41.52; P  = 0.192) and six months (28.22 ± 20.96 against 36.08 ± 36.19; P  = 0.189) between the groups the intervention group was more mobile. CONCLUSION This intervention improved function, mobility and quality of life in persons following lower limb amputation in the first three months post amputation.",2020,"This intervention improved function, mobility and quality of life in persons following lower limb amputation in the first three months post amputation.","['persons with lower limb amputations', '154 participants (54 female; mean age 58', 'people with lower limb amputation due to peripheral vascular disease']","['home exercise intervention', 'home-based exercise and education programme', 'home-based exercise and education programme (n\u2009=\u200977) with usual care (control']","['function, mobility and quality of life', 'Barthel Index, Participation Scale, EuroQuol 5D, Modified Locomotor Capability Index and Timed Up and Go Test', 'EuroQuol5D visual analogue scale', 'Modified Capability Index', 'EuroQuol5D utility index']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0085096', 'cui_str': 'Peripheral Angiopathies'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",154.0,0.0874478,"This intervention improved function, mobility and quality of life in persons following lower limb amputation in the first three months post amputation.","[{'ForeName': 'Lonwabo', 'Initials': 'L', 'LastName': 'Godlwana', 'Affiliation': 'Department of Physiotherapy, School of Therapeutic Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Physiotherapy, School of Therapeutic Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eustasius', 'Initials': 'E', 'LastName': 'Musenge', 'Affiliation': 'School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Clinical rehabilitation,['10.1177/0269215519880295'] 1362,31540791,"Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND Localised prostate cancer is commonly treated with external-beam radiotherapy. Moderate hypofractionation has been shown to be non-inferior to conventional fractionation. Ultra-hypofractionated stereotactic body radiotherapy would allow shorter treatment courses but could increase acute toxicity compared with conventionally fractionated or moderately hypofractionated radiotherapy. We report the acute toxicity findings from a randomised trial of standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy for low-risk to intermediate-risk localised prostate cancer. METHODS PACE is an international, phase 3, open-label, randomised, non-inferiority trial. In PACE-B, eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4 + 3 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada). Participants were randomly allocated (1:1) by computerised central randomisation with permuted blocks (size four and six), stratified by centre and risk group, to conventionally fractionated or moderately hypofractionated radiotherapy (78 Gy in 39 fractions over 7·8 weeks or 62 Gy in 20 fractions over 4 weeks, respectively) or stereotactic body radiotherapy (36·25 Gy in five fractions over 1-2 weeks). Neither participants nor investigators were masked to allocation. Androgen deprivation was not permitted. The primary endpoint of PACE-B is freedom from biochemical or clinical failure. The coprimary outcomes for this acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score up to 12 weeks after radiotherapy. Analysis was per protocol. This study is registered with ClinicalTrials.gov, NCT01584258. PACE-B recruitment is complete and follow-up is ongoing. FINDINGS Between Aug 7, 2012, and Jan 4, 2018, we randomly assigned 874 men to conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy (n=433). 432 (98%) of 441 patients allocated to conventionally fractionated or moderately hypofractionated radiotherapy and 415 (96%) of 433 patients allocated to stereotactic body radiotherapy received at least one fraction of allocated treatment. Worst acute RTOG gastrointestinal toxic effect proportions were as follows: grade 2 or more severe toxic events in 53 (12%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 43 (10%) of 415 patients in the stereotactic body radiotherapy group (difference -1·9 percentage points, 95% CI -6·2 to 2·4; p=0·38). Worst acute RTOG genitourinary toxicity proportions were as follows: grade 2 or worse toxicity in 118 (27%) of 432 patients in the conventionally fractionated or moderately hypofractionated radiotherapy group versus 96 (23%) of 415 patients in the stereotactic body radiotherapy group (difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16). No treatment-related deaths occurred. INTERPRETATION Previous evidence (from the HYPO-RT-PC trial) suggested higher patient-reported toxicity with ultrahypofractionation. By contrast, our results suggest that substantially shortening treatment courses with stereotactic body radiotherapy does not increase either gastrointestinal or genitourinary acute toxicity. FUNDING Accuray and National Institute of Health Research.",2019,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","['eligible men aged 18 years and older, with WHO performance status 0-2, low-risk or intermediate-risk prostate adenocarcinoma (Gleason 4\u2008+\u20083 excluded), and scheduled to receive radiotherapy were recruited from 37 centres in three countries (UK, Ireland, and Canada', '874 men to', '432 (98%) of 441 patients allocated to', 'Between Aug 7, 2012, and Jan 4, 2018', '433 patients allocated to']","['hypofractionated radiotherapy', 'stereotactic body radiotherapy', 'Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy (n=441) or stereotactic body radiotherapy', 'conventionally fractionated or moderately hypofractionated radiotherapy', 'Ultra-hypofractionated stereotactic body radiotherapy', 'standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy', 'external-beam radiotherapy', 'conventionally fractionated or moderately hypofractionated', 'radiotherapy']","['acute toxicity substudy were worst grade 2 or more severe Radiation Therapy Oncology Group (RTOG) gastrointestinal or genitourinary toxic effects score', 'acute toxicity', 'toxicity', 'Androgen deprivation', 'PACE-B is freedom from biochemical or clinical failure', 'gastrointestinal or genitourinary acute toxicity', 'severe toxic events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",874.0,0.279497,"difference -4·2 percentage points, 95% CI -10·0 to 1·7; p=0·16).","[{'ForeName': 'Douglas H', 'Initials': 'DH', 'LastName': 'Brand', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Tree', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ostler', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Voet', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'The Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Camilleri', 'Affiliation': 'Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kancherla', 'Affiliation': 'University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Frew', 'Affiliation': 'Freeman Hospital, Newcastle, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'University Hospitals Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Dayes', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burnett', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Duffton', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hinder', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Morrison', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK. Electronic address: nicholas.vanas@rmh.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30569-8'] 1363,31578111,Intraoperative superior hypogastric plexus block during cesarean section: a new technique for pain relief.,"Background: With increasing cesarean section rates all around the world, postoperative pain management is an important issue for all women. Good postoperative pain management helps to shorten the recovery period of the mother, improve the mother's feeling of well-being, enable good breastfeeding, and provide optimum maternal-neonatal bonding. Objective: To evaluate the efficacy of intraoperative superior hypogastric plexus block (SHPB) during cesarean section and describe the technique. Study design: This was a prospective quasi-experimental study that was conducted with 69 pregnant women at HSU. Kocaeli Derince Training and Research Hospital Obstetrics and Gynecology Clinics between 15 March 2018 and 15 August 2018. The case group included 34 healthy pregnant women who received SHPB (SHPB+) for postoperative pain relief during cesarean section under general anesthesia, and the control group included 35 healthy pregnant women who did not receive SHPB during cesarean section with general anesthesia (SHPB-). Postoperative 1st hour, 6th hour, 12th hour, 24th hour, and 48th hour visual analog scale (VAS) scores, the amount of analgesics used for pain relief, and the time of the postoperative first gas extraction were assessed. Results: The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p  < .001). The mean postoperative 1st hour VAS score of the SHPB (+) group was 4.74 ± 1.44, and was 6.80 ± 2.08 for the SHPB (-) group. There were no differences in postoperative 6th hour, 12th hour, 24th hour, and 48th hour VAS scores between the groups. When the SHPB (+) and SHPB (-) groups were compared for postoperative analgesic use and for the first postoperative gas extraction time, the SHPB (+) group had lower analgesic use ( p  < .001), and the SHPB (-) group had earlier gas extraction. The mean analgesic use in the SHPB (+) group was 2.29 ± 1.11 and it was 4 ± 0.84 in SHPB (-) group. The mean gas extraction time for the SHPB (-) group was 18.03 ± 7.2 h, and was 24.56 ± 8.56 h for the SHPB (+) group ( p  = .001). Conclusion: SHPB performed intraoperatively in cesarean section procedures with general anesthesia is a simple, easy approach to perform during open surgery with direct vision. SHPB helps postoperative pain management extensively with low postoperative VAS scores and low analgesic requirement.",2020,The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p < 0.001).,"['34 healthy pregnant women who received', 'cesarean section', '69 pregnant women at HSU', 'cesarean section procedures with general anesthesia', 'for postoperative pain relief during cesarean section under general anesthesia, and the control group included 35 healthy pregnant women who did not receive SHPB during cesarean section with general anesthesia (SHPB ']","['intraoperative superior hypogastric plexus block (SHPB', 'Intraoperative superior hypogastric plexus block', 'SHPB (SHPB ', 'SHPB']","['mean gas extraction time', 'VAS scores', '48th hour visual analogue scale (VAS) scores', 'cesarean section rates', 'pain relief, and the time of the postoperative first gas extraction', 'mean analgesic use', 'mean postoperative 1st hour VAS score', 'postoperative 6th hour, 12th hour, 24th hour, and 48th hour VAS scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0229047', 'cui_str': 'Structure of superior hypogastric plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}]",35.0,0.0289746,The SHPB (+) group had lower 1st hour VAS scores than the SHPB (-) group ( p < 0.001).,"[{'ForeName': 'Bahar Sarıibrahim', 'Initials': 'BS', 'LastName': 'Astepe', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hande Gürbüz', 'Initials': 'HG', 'LastName': 'Aytuluk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ünal', 'Initials': 'Ü', 'LastName': 'Türkay', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1676414'] 1364,31609870,Caregiver-Delivered Foot Reflexology: Effects on Patients and Caregivers.,"The aim of this study was to evaluate the effects of caregiver-delivered foot reflexology on patients with cancer and their caregivers. A 2-group pre- and posttest design was used in this study, and the study was conducted in an oncology hospital between January 2016 and February 2018. The study included 60 patients and 60 caregivers. Caregivers performed interventions once a day for 15 days. Patients in the experimental group received reflexology, and patients in the control group were included in the reading session. Mean pain, anxiety, and fatigue levels significantly decreased for the patients who received foot reflexology from their caregivers for 15 days compared with patients in the control group. The mean care burden score of the caregivers in both groups decreased. Clinicians should teach caregiving practices such as foot reflexology and know that these practices are a positive influence on both patients and caregivers.",2019,"Mean pain, anxiety, and fatigue levels significantly decreased for the patients who received foot reflexology from their caregivers for 15 days compared with patients in the control group.","['patients with cancer and their caregivers', '60 patients and 60 caregivers', 'Patients and Caregivers', 'oncology hospital between January 2016 and February 2018']","['Caregiver-Delivered Foot Reflexology', 'caregiver-delivered foot reflexology', 'reflexology']","['mean care burden score', 'Mean pain, anxiety, and fatigue levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0198156,"Mean pain, anxiety, and fatigue levels significantly decreased for the patients who received foot reflexology from their caregivers for 15 days compared with patients in the control group.","[{'ForeName': 'Sevgin', 'Initials': 'S', 'LastName': 'Samancioglu Baglama', 'Affiliation': 'Nursing Department, Health Science Faculty, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Bakir', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000351'] 1365,31491583,Additive effectiveness of contingency management on cognitive behavioural treatment for smokers with depression: Six-month abstinence and depression outcomes.,"BACKGROUND Depression and smoking co-occur at high rates and there is a lack of evidence on the efficacy of treatments specifically tailored to this population. This randomized controlled trial sought to compare the effectiveness of cognitive behavioural treatment (CBT) combined with behavioural activation (BA) and the same treatment protocol plus contingency management (CM). METHODS A sample of 120 adult smokers (70.8%: females) with severe depressive symptoms were randomly allocated to: CBT + BA (n = 60) or CBT + BA + CM (n = 60). Smoking and depression outcomes were reported at end of treatment, 1-, 2-, 3-, and 6-month follow-ups. Self-reported smoking status was biochemically verified, and depression was assessed using the Beck Depression Inventory-II. RESULTS At end of treatment, the overall quit rate was 69.2% (83/120). CM showed an additive effect on CBT + BA in enhancing abstinence rates. The significant effect of group [F(1,155) = 9.55, p =  .0024], time [F(4,96) = 7.93, p < .0001], and group by time interaction [F(4,96) = 6.12, p =  .0002], indicated that CM is more effective for generating longer durations of abstinence beyond those of CBT+BA. All treatment conditions equally promoted sustained reductions in depression across time [F(1,111) = 0.53, p =  .4665]. A greater number of days of continuous abstinence and lower depressive symptoms mutually influenced each other. CONCLUSIONS Depressed smokers achieve high cessation rates without suffering negative mood changes. Quitting smoking is not detrimental and adding CM to CBT + BA enhances long-lasting abstinence rates while promoting large depression improvements.",2019,"The significant effect of group [F(1,155) = 9.55, p =  .0024], time [F(4,96) = 7.93, p < .0001], and group by time interaction [F(4,96) = 6.12, p =  .0002], indicated that CM is more effective for generating longer durations of abstinence beyond those of CBT+BA.","['smokers with depression', '120 adult smokers (70.8%: females) with severe depressive symptoms']","['cognitive behavioural treatment (CBT) combined with behavioural activation (BA) and the same treatment protocol plus contingency management (CM', 'CBT\u202f+\u202fBA (n\u202f=\u202f60) or CBT\u202f+\u202fBA\u202f+\u202fCM', 'contingency management']","['Smoking and depression outcomes', 'number of days of continuous abstinence and lower depressive symptoms', 'overall quit rate']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040808', 'cui_str': 'Treatment Protocols'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",120.0,0.0940232,"The significant effect of group [F(1,155) = 9.55, p =  .0024], time [F(4,96) = 7.93, p < .0001], and group by time interaction [F(4,96) = 6.12, p =  .0002], indicated that CM is more effective for generating longer durations of abstinence beyond those of CBT+BA.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain. Electronic address: albagroz@cop.es.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Vallejo-Seco', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alonso-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.06.003'] 1366,31861714,Functional Changes in Patients and Morphological Changes in the Lumbar Intervertebral Disc after Applying Lordotic Curve-Controlled Traction: A Double-Blind Randomized Controlled Study.,"Background and O bjectives: Lumbar traction is widely used as a non-operative treatment for lumbar intervertebral disc disease. The effect of traditional traction (TT) using linear-type traction devices remains controversial for various reasons, including technical limitations. Thus, the purpose of this study was to compare the effects of the newly developed lumbar lordotic curve-controlled traction (L-LCCT) and TT on functional changes in patients and morphological changes in the vertebral disc. Materials and Methods: A total of 40 patients with lumbar intervertebral disc disease at the L4/5 or L5/S1 level as confirmed by magnetic resonance imaging were recruited and divided into two groups (L-LCCT or TT). The comprehensive health status changes of the patients were recorded using pain and functional scores (the visual analogue scale, the Oswestry Disability Index, and the Roland-Morris Disability Questionnaire) and morphological changes (in the lumbar central canal area) before and after traction treatment. Results: Pain scores were significantly decreased after traction in both groups ( p < 0.05). However, functional scores and morphological changes improved significantly after treatment in the L-LCCT group only ( p < 0.05). Conclusions: We suggest that L-LCCT is a viable option for resolving the technical limitations of TT by maintaining the lumbar lordotic curve in patients with lumbar intervertebral disc disease.",2019,"However, functional scores and morphological changes improved significantly after treatment in the L-LCCT group only ( p < 0.05). ","['patients with lumbar intervertebral disc disease', 'lumbar intervertebral disc disease', '40 patients with lumbar intervertebral disc disease at the L4/5 or L5/S1 level as confirmed by magnetic resonance imaging', 'patients and morphological changes in the vertebral disc', 'Patients and Morphological Changes in the Lumbar Intervertebral Disc after Applying Lordotic Curve-Controlled Traction']","['traditional traction (TT', 'Lumbar traction', 'lumbar lordotic curve-controlled traction (L-LCCT) and TT', 'L-LCCT']","['pain and functional scores (the visual analogue scale, the Oswestry Disability Index, and the Roland-Morris Disability Questionnaire) and morphological changes', 'functional scores and morphological changes', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0158252', 'cui_str': 'Intervertebral disc disease'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0021815', 'cui_str': 'Intervertebral Disc'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0556666', 'cui_str': 'Lumbar traction (procedure)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",40.0,0.0345858,"However, functional scores and morphological changes improved significantly after treatment in the L-LCCT group only ( p < 0.05). ","[{'ForeName': 'Chang-Hyung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Rehabilitation Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Heo', 'Affiliation': 'Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}, {'ForeName': 'So Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Youngsan University, Yangsan 50510, Korea.'}, {'ForeName': 'Hee Seok', 'Initials': 'HS', 'LastName': 'Jeong', 'Affiliation': 'Radiology Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}, {'ForeName': 'Soo-Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Rehabilitation Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56010004'] 1367,29341850,Clinical Inertia in a Randomized Trial of Telemedicine-Based Chronic Disease Management: Lessons Learned.,"BACKGROUND Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. INTRODUCTION We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. METHODS In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention. This intervention comprised two nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia). For each medication management facilitation encounter, we ascertained whether patients met treatment goals, and if not, whether primary care recommended treatment intensification following the encounter. We assessed disease control associated with encounters, where intensification was/was not recommended. RESULTS We examined 455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes). Even after accounting for valid reasons for deferring intensification (e.g., treatment nonadherence), intensification was not recommended in 67.5% of encounters in which hemoglobin A1c was above goal, 72.5% in which systolic blood pressure was above goal, and 73.9% in which low-density lipoprotein cholesterol was above goal. In each disease state, treatment intensification was more likely with poorer control. CONCLUSIONS Despite enhancing treatment adherence, this intervention was unsuccessful in countering clinical inertia, likely explaining its lack of effect on CVD risk factors. We identify several lessons learned that may benefit investigators and healthcare systems.",2018,"We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. ","['Based Chronic Disease Management', '455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes']","['Telemedicine', 'nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia', 'telemedicine intervention', 'Telemedicine interventions']",['systolic blood pressure'],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0411529,"We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. ","[{'ForeName': 'Anna Beth', 'Initials': 'AB', 'LastName': 'Barton', 'Affiliation': '1 Richmond Diabetes and Endocrinology, Bon Secours Medical Group , Richmond, Virginia.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Okorodudu', 'Affiliation': '2 Endocrinology Service, Guadalupe Regional Medical Center , Seguin, Texas.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': '3 Center for Health Services Research in Primary Care , Durham VAMC, Durham, North Carolina.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': '3 Center for Health Services Research in Primary Care , Durham VAMC, Durham, North Carolina.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2017.0184'] 1368,29217376,"Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.","BACKGROUND The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. METHODS We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461. FINDINGS VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site was the most frequent local symptoms (37 [46%] of 80 participants in VRC 319 and 36 [80%] of 45 in VRC 320) and malaise and headache were the most frequent systemic symptoms (22 [27%] and 18 [22%], respectively, in VRC 319 and 17 [38%] and 15 [33%], respectively, in VRC 320). For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. INTERPRETATION VRC5283 was well tolerated and has advanced to phase 2 efficacy testing. FUNDING Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health.",2018,"For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. ","['VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group', 'In VRC 320 participants', 'Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320', 'In VRC 319 participants', 'healthy adult volunteers', 'healthy adults']","['syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA', 'Zika virus DNA vaccine candidates', 'intramuscular injection of 4 mg vaccine', 'vaccinations via needle and syringe']","['safe and well tolerated', 'geometric mean titre', 'malaise and headache', 'adverse events', 'local symptoms', 'pain and tenderness', 'plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera', 'local and systemic reactogenicity', 'systemic symptoms', 'Safety, tolerability, and immunogenicity']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0234242', 'cui_str': 'Pain and tenderness (finding)'}, {'cui': 'C0032136', 'cui_str': 'Plasmids'}, {'cui': 'C0318793', 'cui_str': 'ZikV'}, {'cui': 'C0014047', 'cui_str': 'Japanese encephalitis virus'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",320.0,0.194294,"For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials. ","[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Houser', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kaitlyn M', 'Initials': 'KM', 'LastName': 'Morabito', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Yamshchikov', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ro Shauna', 'Initials': 'RS', 'LastName': 'Rothwell', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Floreliz', 'Initials': 'F', 'LastName': 'Mendoza', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jamie G', 'Initials': 'JG', 'LastName': 'Saunders', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Novik', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Hendel', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Hope Clinic of the Emory Vaccine Center, Emory School of Medicine, Decatur, GA, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'McArthur', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nadine G', 'Initials': 'NG', 'LastName': 'Rouphael', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Hope Clinic of the Emory Vaccine Center, Emory School of Medicine, Decatur, GA, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ginny E', 'Initials': 'GE', 'LastName': 'Cummings', 'Affiliation': 'University of Maryland Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sitar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bryant M', 'Initials': 'BM', 'LastName': 'Foreman', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Burgomaster', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Pelc', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Gordon', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'DeMaso', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Dowd', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Laurencot', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Pierson', 'Affiliation': 'Viral Pathogenesis Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: grace.chen@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(17)33105-7'] 1369,31621523,"Improving HbA 1c with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial.","Background: We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA 1c and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system. Methods: Sixty-five ( n  = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA 1c and ΔFBG were analyzed after 6 months. Results: There was an absolute HbA 1c reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA 1c >8%, HbA 1c decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA 1c . Conclusions: EpxDiabetes helps to reduce HbA 1c in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.",2020,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","['Diabetic Patients with EpxDiabetes', 'Methods: Sixty-five ( n \u2009=\u200965', 'patients with type 2 diabetes mellitus (T2DM']",['novel digital health intervention'],"['FBG', 'HbA 1c and fasting blood glucose (FBG', 'HbA 1c', 'Smoking, number of comorbidities, and response rate', 'ΔHbA 1c and ΔFBG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0600336,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Xing', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kavon', 'Initials': 'K', 'LastName': 'Javaherian', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Ross', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Mizrachi', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0035'] 1370,31479863,Gaze entropy measures detect alcohol-induced driver impairment.,"Driving under the influence of alcohol is an ongoing cause of road traffic accidents. The biphasic nature of alcohol effects on subjective experience appears to contribute to the prevalence of drink-driving, as people perceive the declining phase of the BAC curve as recovery from intoxication and are more willing to drive despite significant impairments in objectively measured functions. The present study investigates whether alcohol-induced changes in gaze behaviour can be detected during engagement in a simulated driving task. In a repeated-measures and placebo-controlled design, this study examines the biphasic influence of moderate alcohol intake (0.6 g/kg) on measures of gaze behaviour and simulated driving performance. Twenty-two healthy young adults completed three driving sessions (baseline, ascending and descending) under two conditions (placebo, alcohol) while their eye movements were simultaneously recorded. The results revealed that gaze behaviour as measured by gaze transition entropy (GTE) and stationary gaze entropy (SGE) and driving performance measured by the standard deviation of lateral position (SDLP) of the vehicle, were significantly affected by alcohol across the ascending and descending sessions. The alcohol-induced reduction in GTE with an increase in SGE is discussed as alcohol's impact on top-down modulation of gaze resulting in more dispersed and erratic pattern of visual scanning. The observed changes in gaze behaviour also mediated the influence of alcohol upon driving performance. These results have significant implications for the development of driver monitoring systems that can detect alcohol-induced impairment.",2019,"The results revealed that gaze behaviour as measured by gaze transition entropy (GTE) and stationary gaze entropy (SGE) and driving performance measured by the standard deviation of lateral position (SDLP) of the vehicle, were significantly affected by alcohol across the ascending and descending sessions.",['Twenty-two healthy young adults'],"['placebo', 'driving sessions (baseline, ascending and descending) under two conditions (placebo, alcohol']","['gaze transition entropy (GTE) and stationary gaze entropy (SGE) and driving performance', 'Gaze entropy measures detect alcohol-induced driver impairment', 'gaze behaviour', 'gaze behaviour and simulated driving performance']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",22.0,0.0188674,"The results revealed that gaze behaviour as measured by gaze transition entropy (GTE) and stationary gaze entropy (SGE) and driving performance measured by the standard deviation of lateral position (SDLP) of the vehicle, were significantly affected by alcohol across the ascending and descending sessions.","[{'ForeName': 'Brook A', 'Initials': 'BA', 'LastName': 'Shiferaw', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC 3122, Australia. Electronic address: bshiferaw@swin.edu.au.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Crewther', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC 3122, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, VIC 3122, Australia; Institute for Breathing and Sleep, Austin Hospital, Heidelberg, VIC 3084, Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.06.021'] 1371,31851240,Hammock and nesting in preterm infants: randomized controlled trial.,"OBJECTIVE To compare the physiological variables and the sleep-wake pattern presented by preterm in nesting and hammock positions after diaper change. METHOD This is a crossover randomized controlled trial. It was conducted with 20 preterm infants who, after diaper change, were placed in nests or hammocks. These preterm infants were evaluated for physiological variables (heart rate and oxygen saturation) and behavioral variables (sleep and wakefulness). RESULTS There was no statistically significant difference in the studied variables between nesting and hammock positions. However, regarding the categorical variable sleep, the comparison between the research phases for the hammock position showed differences between the baseline phase and the immediate recovery (p=0.00), baseline and late recovery (p=0.00), response and immediate recovery (p=0.00), response and late recovery (p=0.00). CONCLUSION No differences were identified between the nest and the hammock; however, the use of the hammock favored the sleep of preterm infants compared to its non-use.",2019,"No differences were identified between the nest and the hammock; however, the use of the hammock favored the sleep of preterm infants compared to its non-use.","['preterm infants', '20 preterm infants who, after diaper change, were placed in nests or hammocks']",[],"['physiological variables (heart rate and oxygen saturation) and behavioral variables (sleep and wakefulness', 'immediate recovery (p=0.00), baseline and late recovery (p=0.00), response and immediate recovery (p=0.00), response and late recovery']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0180416', 'cui_str': 'Nappy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",,0.0905325,"No differences were identified between the nest and the hammock; however, the use of the hammock favored the sleep of preterm infants compared to its non-use.","[{'ForeName': 'Kassandra Silva Falcão', 'Initials': 'KSF', 'LastName': 'Costa', 'Affiliation': 'Universidade de Brasília. Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Danielle da Silva', 'Initials': 'DDS', 'LastName': 'Fernandes', 'Affiliation': 'Universidade de Brasília. Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Rayanne Augusta Parente', 'Initials': 'RAP', 'LastName': 'Paula', 'Affiliation': 'Universidade de Brasília. Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Laíse Escalianti Del Alamo', 'Initials': 'LEDA', 'LastName': 'Guarda', 'Affiliation': 'Universidade de Brasília. Brasília, Distrito Federal, Brazil.'}, {'ForeName': 'Mariana Firmino', 'Initials': 'MF', 'LastName': 'Daré', 'Affiliation': 'Universidade de São Paulo. Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Thaíla Côrrea', 'Initials': 'TC', 'LastName': 'Castral', 'Affiliation': 'Universidade Federal de Goiás. Goiânia, Goiás, Brazil.'}, {'ForeName': 'Laiane Medeiros', 'Initials': 'LM', 'LastName': 'Ribeiro', 'Affiliation': 'Universidade de Brasília. Brasília, Distrito Federal, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2018-0099'] 1372,31621640,"Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus.","BACKGROUND Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). OBJECTIVE This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). METHODS The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. RESULTS A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were -2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA 1c (P value for change over time <.001). CONCLUSIONS The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. TRIAL REGISTRATION ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506.",2019,"Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). ","['Ethnic Minority Adults With Type 2 Diabetes Mellitus', 'ethnic minority patients with T2DM', 'low-socioeconomic status (SES) ethnic minority patients with T2DM and (2', 'Diabetes-Related Dietary Knowledge', 'ethnically diverse populations', 'A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively', '50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics']","['4-session dietician-delivered lifestyle counseling intervention', 'standard lifestyle advice (SLA', '4 in-person, dietician-delivered counseling sessions', 'adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling', 'Electronic, Culturally Adapted Lifestyle Counseling Tool']","['total energy', 'mean (SE) differences in added sugar and dietary fiber intakes', 'efficiency of lifestyle education', 'DM-related dietary knowledge', 'DM-related lifestyle knowledge', 'odds of engaging in any leisure PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]",25.0,0.0828352,"Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). ","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Abu-Saad', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Havi', 'Initials': 'H', 'LastName': 'Murad', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Rivka', 'Initials': 'R', 'LastName': 'Barid', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Liraz', 'Initials': 'L', 'LastName': 'Olmer', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Arnona', 'Initials': 'A', 'LastName': 'Ziv', 'Affiliation': 'Information and Computerization Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Nuha', 'Initials': 'N', 'LastName': 'Younis-Zeidan', 'Affiliation': 'Diet and Nutrition Service Unit for the Arab population in Sharon-Shomron District, Clalit Health Services, Arara, Israel.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Kaufman-Shriqui', 'Affiliation': 'Department of Nutritional Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gillon-Keren', 'Affiliation': ""Institute of Endocrinology and Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel.""}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Rigler', 'Affiliation': 'Sharon-Shomron District, Clalit Health Services, Hadera, Israel.'}, {'ForeName': 'Yakir', 'Initials': 'Y', 'LastName': 'Berchenko', 'Affiliation': 'Biostatistics and Biomathematics Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}, {'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Kalter-Leibovici', 'Affiliation': 'Cardiovascular Epidemiology Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat Gan, Israel.'}]",Journal of medical Internet research,['10.2196/13674'] 1373,31610401,Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study.,"BACKGROUND There is a high level of interest in the potential role of diet among the MS community. There is a limited level of evidence for a Mediterranean-style dietary pattern in MS; the feasibility of conducting studies using educational tools to deliver this type of intervention and study its effects is unknown. OBJECTIVES To establish clinical trial feasibility for future studies utilizing educational delivery of a dietary intervention in MS; to explore the effects of a modified Mediterranean dietary intervention in MS. METHODS We randomly assigned women with MS to follow/not follow the prescribed modified Mediterranean dietary intervention for 6 months, delivered through educational sessions. The diet encouraged the intake of fish and other foods high in poly- and monounsaturated fats, fresh fruits, vegetables, and whole grains and eliminated meat, dairy, and most processed foods and limited salt intake to <2 g/day. Primary endpoints related to meeting target enrollment within the specified time frame, adherence, and study completion. Clinical endpoints were evaluated in an exploratory fashion. RESULTS We screened 128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year. Self-reported adherence was excellent (90.3%), with an overall study completion rate of 94.4%. The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. CONCLUSIONS It is reasonable to expect a high level of interest and commitment to this type of dietary intervention study in MS, and feasible to deliver it purely through education in a clinical setting with high adherence levels despite restrictive requirements. In this pilot study, a modified Mediterranean dietary intervention reduced fatigue, impact of MS symptoms, and disability. Further work is needed.",2019,"The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. ","['128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year', 'multiple sclerosis']","['modified Mediterranean dietary program', 'modified Mediterranean dietary intervention', 'dietary intervention']","['Multiple Sclerosis Impact Scale-29 scores', 'fatigue, impact of MS symptoms, and disability', 'trajectory of Neurological Fatigue Index-MS scores', 'Self-reported adherence', 'Expanded Disability Status Scale', 'meeting target enrollment within the specified time frame, adherence, and study completion']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1444698', 'cui_str': 'Specified time'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",36.0,0.0452806,"The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. ","[{'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Katz Sand', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, United States. Electronic address: ilana.katzsand@mssm.edu.'}, {'ForeName': 'Emma K T', 'Initials': 'EKT', 'LastName': 'Benn', 'Affiliation': 'Center for Biostatistics and Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fabian', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Neurology, Johns Hopkins, United States.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Digga', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Deshpande', 'Affiliation': 'Center for Biostatistics and Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Department of Clinical Nutrition, The Mount Sinai Hospital, United States.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Arab', 'Affiliation': 'Department of Medicine, The David Geffen School of Medicine, University of California Los Angeles, United States.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2019.101403'] 1374,29292684,Psychologic Evaluation in Liver Transplantation: Assessment of Psychologic Profile of End-Stage Liver Disease Patients Before and After Transplant.,"OBJECTIVES Patients with end-stage liver disease face various psychologic challenges. We aimed to compare levels of depression, anxiety, fatigue, sleepiness, and memory in patients before and after liver transplant. MATERIALS AND METHODS Forty patients (24 male, 16 female) were recruited from the liver transplant clinic affiliated with Shiraz University of Medical Sciences. Patients between 18 and 60 years old with at least a 6th-grade level of education were included in the study; those with severe psychiatric problems were excluded. We performed the following assessments before and 1 month after liver transplant: Hospital Anxiety and Depression questionnaires, California Verbal Learning Test, Epworth Sleepiness Scale, and Fatigue Severity Scale. Paired-sample t tests were used. P < .05 was considered significant. RESULTS Level of depression in study patients increased after transplant (7.42 vs 8.42; P = .008). We found improvements in categories of immediate memory (65.23 vs 60; P = .007), short delay free recall (10.52 vs 12.52; P < .001), short delay cued recall (11.42 vs 13.00; P = .001), long delay free recall (10.80 vs 12.50; P = .003), long delay cued recall (11.80 vs 13.25; P = .003), and recognition (14.65 vs 15.42; P = .003). Patient levels of fatigue (39.9 vs 33.2; P = .029) and sleepiness (10.8 vs 7.8; P = .004) decreased. Level of anxiety did not change significantly (12.6 vs 12.8; P = .642). CONCLUSIONS We observed higher levels of depression but improved fatigue, sleepiness, and memory function in patients after liver transplant. No significant change in patient level of anxiety was seen. Future direction is discussed.",2020,"We found improvements in categories of immediate memory (65.23 vs 60; P = .007), short delay free recall (10.52 vs 12.52; P < .001), short delay cued recall (11.42 vs 13.00; P = .001), long delay free recall (10.80 vs 12.50; P = .003), long delay cued recall (11.80 vs 13.25; P = .003), and recognition (14.65 vs 15.42; P = .003).","['End-Stage Liver Disease Patients Before and After Transplant', 'Liver Transplantation', 'Patients with end-stage liver disease face various psychologic challenges', 'Forty patients (24 male, 16 female) were recruited from the liver transplant clinic affiliated with Shiraz University of Medical Sciences', 'Patients between 18 and 60 years old with at least a 6th-grade level of education were included in the study; those with severe psychiatric problems were excluded', 'patients after liver transplant', 'patients before and after liver transplant']",[],"['patient level of anxiety', 'fatigue, sleepiness, and memory function', 'short delay free recall', 'long delay free recall', 'Level of depression', 'levels of depression, anxiety, fatigue, sleepiness, and memory', 'short delay cued recall', 'Hospital Anxiety and Depression questionnaires, California Verbal Learning Test, Epworth Sleepiness Scale, and Fatigue Severity Scale', 'Patient levels of fatigue', 'sleepiness', 'categories of immediate memory', 'long delay cued recall', 'Level of anxiety']","[{'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.0364383,"We found improvements in categories of immediate memory (65.23 vs 60; P = .007), short delay free recall (10.52 vs 12.52; P < .001), short delay cued recall (11.42 vs 13.00; P = .001), long delay free recall (10.80 vs 12.50; P = .003), long delay cued recall (11.80 vs 13.25; P = .003), and recognition (14.65 vs 15.42; P = .003).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Baghernezhad', 'Affiliation': 'From the Transplant Research Center, the Research Center for Psychiatry and Behavioral Sciences, and the Shiraz Nephrology and Urology Research Center, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mani', 'Affiliation': ''}, {'ForeName': 'Anaheed', 'Initials': 'A', 'LastName': 'Ayoobzadehshirazi', 'Affiliation': ''}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Roozbeh', 'Affiliation': ''}, {'ForeName': 'Maasoomeh', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': ''}, {'ForeName': 'Saman', 'Initials': 'S', 'LastName': 'Nikeghbalian', 'Affiliation': ''}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Malek-Hosseini', 'Affiliation': ''}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Gholam', 'Affiliation': ''}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Bazargan-Hejazi', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2017.0135'] 1375,29150051,Glutamate is down-regulated and tinnitus loudness-levels decreased following rTMS over auditory cortex of the left hemisphere: A prospective randomized single-blinded sham-controlled cross-over study.,"Using a prospective randomized single-blinded sham-controlled cross-over design, we studied the efficacy of low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS) over auditory cortex of the left temporal lobe as an experimental treatment modality for noise-induced tinnitus. Pre/post outcome measures for sham vs. active rTMS conditions included differential changes in tinnitus loudness, self-perceived changes in the Tinnitus Handicap Questionnaire (THQ), and neurochemical changes of brain metabolite concentrations using single voxel proton magnetic resonance spectroscopy ( 1 H-MRS) obtained from left and right auditory cortical areas. While no subject in our sample had complete abatement of their tinnitus percept, active but not sham rTMS significantly reduced the loudness level of the tinnitus perception on the order of 4.5 dB; improved subscales in several content areas on the THQ, and down regulated (reduced) glutamate concentrations specific to the auditory cortex of the left temporal lobe that was stimulated. In addition, significant pair-wise correlations were observed among questionnaire variables, metabolite variables, questionnaire-metabolite variables, and metabolite-loudness variables. As part of this correlation analysis, we demonstrate for the first time that active rTMS produced a down regulation in the excitatory neurotransmitter glutamate that was highly correlated (r = 0.77, p < 0.05) with a reduction in tinnitus loudness levels measured psychoacoustically with a magnitude estimation procedure. Overall, this study provides unique information on neurochemical, psychoacoustic, and questionnaire-related profiles which emphasizes the emerging fields of perceptual and cognitive MRS and provides a perspective on a new frontier in auditory and tinnitus-related research.",2018,"0.77, p < 0.05) with a reduction in tinnitus loudness levels measured psychoacoustically with a magnitude estimation procedure.",['noise-induced tinnitus'],"['rTMS', 'sham vs. active rTMS', 'low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS']","['questionnaire variables, metabolite variables, questionnaire-metabolite variables, and metabolite-loudness variables', 'tinnitus loudness levels', 'loudness level of the tinnitus perception', 'tinnitus loudness, self-perceived changes in the Tinnitus Handicap Questionnaire (THQ), and neurochemical changes of brain metabolite concentrations']","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.071251,"0.77, p < 0.05) with a reduction in tinnitus loudness levels measured psychoacoustically with a magnitude estimation procedure.","[{'ForeName': 'Anthony T', 'Initials': 'AT', 'LastName': 'Cacace', 'Affiliation': 'Department of Communication Sciences & Disorders, Wayne State University, Detroit, MI, USA. Electronic address: cacacea@wayne.edu.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Department of Psychology, Union College, Schenectady, NY, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xuan', 'Affiliation': 'Department of Radiology, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Burkard', 'Affiliation': 'Department of Rehabilitation Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Tyler', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Iowa, Iowa City, IA, USA; Department of Communication Sciences & Disorders, University of Iowa, Iowa City, IA, USA.'}]",Hearing research,['10.1016/j.heares.2017.10.017'] 1376,31603428,Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study.,"BACKGROUND In a clinical trial, internet-based cognitive behavioral therapy (I-CBT) embedded in stepped care was established as noninferior to face-to-face cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS). However, treatment effects observed in clinical trials may not necessarily be retained after implementation. OBJECTIVE This study aimed to investigate whether stepped care for CFS starting with I-CBT, followed by face-to-face CBT, if needed, was also effective in routine clinical care. Another objective was to explore the role of therapists' attitudes toward electronic health (eHealth) and manualized treatment on treatment outcome. METHODS I-CBT was implemented in five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands. All patients with CFS were offered I-CBT, followed by face-to-face CBT if still severely fatigued or disabled after I-CBT. Outcomes were the Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale. The change scores (pre to post stepped care) were compared with a benchmark: stepped care from a randomized controlled trial (RCT) testing this treatment format. We calculated correlations of therapists' attitudes toward manualized treatment and eHealth with reduction of fatigue severity. RESULTS Overall, 100 CFS patients were referred to the centers. Of them, 79 started with I-CBT, 20 commenced directly with face-to-face CBT, and one did not start at all. After I-CBT, 48 patients met step-up criteria; of them, 11 stepped up to face-to-face CBT. Increase in physical functioning (score of 13.4), social functioning (20.4), and reduction of limitations (10.3) after stepped care delivered in routine clinical care fell within the benchmarks of the RCT (95% CIs: 12.8-17.6; 25.2-7.8; and 7.4-9.8, respectively). Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT (95% CI 13.2-16.5). After I-CBT only, reduction of fatigue severity (13.2) fell within the benchmark of I-CBT alone (95% CI 11.1-14.2). Twenty therapists treated between one and 18 patients. Therapists were divided into two groups: one with the largest median reduction of fatigue and one with the smallest. Patients treated by the first group had a significantly larger reduction of fatigue severity (15.7 vs 9.0; t=2.42; P=.02). There were no (statistically significant) correlations between therapists' attitudes and reduction in fatigue. CONCLUSIONS This study is one of the first to evaluate stepped care with I-CBT as a first step in routine clinical care. Although fatigue severity and disabilities were reduced, reduction of fatigue severity appeared smaller than in the clinical trial. Further development of the treatment should aim at avoiding dropout and encouraging stepping up after I-CBT with limited results. Median reduction of fatigue severity varied largely between therapists. Further research will help understand the role of therapists' attitudes in treatment outcome.",2019,Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT,"['100 CFS patients were referred to the centers', 'All patients with CFS', 'five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands', 'Twenty therapists treated between one and 18 patients']","['Internet-Based Cognitive Behavioral Therapy', 'RCT', 'cognitive behavioral therapy (CBT', 'internet-based cognitive behavioral therapy (I-CBT']","['Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale', 'Reduction of fatigue severity', 'fatigue severity', 'Median reduction of fatigue severity', 'physical functioning (score of 13.4), social functioning', 'reduction of fatigue severity', 'fatigue severity and disabilities', 'fatigue']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",20.0,0.0346078,Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT,"[{'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Worm-Smeitink', 'Affiliation': 'Expert Center for Chronic Fatigue, Department of Medical Psychology, University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'van Dam', 'Affiliation': 'Tranzo, School of Social and Behavioural Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'van Es', 'Affiliation': 'PsyQ Somatiek en Psyche, Parnassia Groep, Amsterdam, Netherlands.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'van der Vaart', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wensing', 'Affiliation': 'Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Expert Center for Chronic Fatigue, Department of Medical Psychology, University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/14037'] 1377,31605208,Balneotherapy for musculoskeletal pain: does the mineral content matter?,"Musculoskeletal pain is a health challenge with various treatment strategies. The study has been accomplished with the aim to reveal the effect of mineral water with different mineral content on musculoskeletal pain and related symptoms experienced. A randomized controlled single-blinded parallel-group study has been performed (145 participants with pain; 5 groups). The duration of treatment was 2 weeks, whereas follow-up has taken 3 months. Change in pain after a single procedure and the pain parameters with related symptoms during the study period have been measured. The effect size using Cohen's d has been estimated. Small effect (0.2-0.4) on pain has been distinguished after each mineral water procedure. Tap water procedures have been effective in 60% of cases. Twenty grams per liter water baths have had a small effect on pain intensity and tender points, body flexibility, and spinal mobility, and a medium one on sleep quality, and reduced CRP. Forty grams per liter water has had a small effect on pain intensity, frequency, and spinal mobility, and a medium one on flexibility, fatigue, and sleep quality, and reduced ESR. Sixty grams per liter water has had a small effect on pain parameters and fatigue, and a medium one on flexibility and sleep quality, and reduced ESR. The effect lasting up to 2 months has been identified mostly in the 60 g/L group. Tap water has had a short time effect on pain intensity and tender points. There have not been any changes of sufficient significance identified in the control group and any differences between mineral water groups. Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified. The consumption of pain medication has significantly decreased in all mineral water groups. The total mineral content of the water has no significant influence on the reduction of musculoskeletal pain. Mineral water baths have small effect on pain and medium effect on other musculoskeletal disease-related symptoms and pain medication consumption lasting up to 3 months; it is more beneficial than tap water or no treatment for the improvement of symptoms associated with musculoskeletal diseases. Even single balneotherapy procedure results in small pain reduction.",2020,"Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified.","['145 participants with pain; 5 groups', 'musculoskeletal pain']",['Balneotherapy'],"['flexibility and sleep quality, and reduced ESR', 'pain intensity, frequency, and spinal mobility, and a medium one on flexibility, fatigue, and sleep quality, and reduced ESR', 'pain intensity, spinal mobility, and sleep quality', 'musculoskeletal pain', 'pain intensity and tender points', 'pain intensity and frequency, flexibility, and spinal mobility', 'small pain reduction', 'pain intensity and tender points, body flexibility, and spinal mobility, and a medium one on sleep quality, and reduced CRP', 'consumption of pain medication', 'Musculoskeletal pain', 'pain parameters and fatigue', 'Change in pain']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}]","[{'cui': 'C0085867', 'cui_str': 'Balneotherapy'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C1562820', 'cui_str': 'Tender point'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",145.0,0.0655306,"Sufficient difference between mineral and tap water groups has been determined in pain intensity, spinal mobility, and sleep quality, whereas in the case of the control group, significant difference in pain intensity and frequency, flexibility, and spinal mobility has been identified.","[{'ForeName': 'Lolita', 'Initials': 'L', 'LastName': 'Rapolienė', 'Affiliation': 'Klaipėda Seamen Health Care Center, Taikos str. 46, LT-91213, Klaipėda, Lithuania. lolita.rapoliene@inbox.lt.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Razbadauskas', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Mockevičienė', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Varžaitytė', 'Affiliation': 'Lithuanian University of Health Sciences, A. Mickevičiaus g. 9, LT44307, Kaunas, Lithuania.'}, {'ForeName': 'Aelita', 'Initials': 'A', 'LastName': 'Skarbalienė', 'Affiliation': 'Klaipėda University, Herkus Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}]",International journal of biometeorology,['10.1007/s00484-019-01800-3'] 1378,27745536,Enhancing the Reach of Cognitive-Behavioral Therapy Targeting Posttraumatic Stress in Acute Care Medical Settings.,"OBJECTIVE Injured patients presenting to acute care medical settings have high rates of posttraumatic stress disorder (PTSD) and comorbidities, such as depression and substance use disorders. Integrating behavioral interventions that target symptoms of PTSD and comorbidities into the acute care setting can overcome common barriers to obtaining mental health care. This study examined the feasibility and acceptability of embedding elements of cognitive-behavioral therapy (CBT) in the delivery of routine postinjury care management. The investigation also explored the potential effectiveness of completion of CBT element homework that targeted PTSD symptom reduction. METHODS This study was a secondary analysis of data from a U.S. clinical trial of the effectiveness of a stepped collaborative care intervention versus usual care for injured inpatients. The investigation examined patients' willingness at baseline (prerandomization) to engage in CBT and pre- and postrandomization mental health service utilization among 115 patients enrolled in the clinical trial. Among intervention patients (N=56), the investigation examined acceptability of the intervention and used multiple linear regression to examine the association between homework completion as reported by the care manager and six-month PTSD symptom reduction as assessed by the PTSD Checklist-Civilian DSM-IV Version. RESULTS Patients in the intervention condition reported obtaining significantly more psychotherapy or counseling than patients in the control group during the six-month follow-up, as well as a high degree of intervention acceptability. Completion of CBT element homework assignments was associated with improvement in PTSD symptoms. CONCLUSIONS Integrating behavioral interventions into routine acute care service delivery may improve the reach of evidence-based mental health care targeting PTSD.",2017,"RESULTS Patients in the intervention condition reported obtaining significantly more psychotherapy or counseling than patients in the control group during the six-month follow-up, as well as a high degree of intervention acceptability.","['Injured patients presenting to acute care medical settings', 'injured inpatients', '115 patients enrolled in the clinical trial']","['cognitive-behavioral therapy (CBT', 'stepped collaborative care intervention', 'CBT element homework']","['PTSD Checklist-Civilian DSM-IV Version', 'psychotherapy or counseling', 'PTSD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",115.0,0.0182015,"RESULTS Patients in the intervention condition reported obtaining significantly more psychotherapy or counseling than patients in the control group during the six-month follow-up, as well as a high degree of intervention acceptability.","[{'ForeName': 'Doyanne', 'Initials': 'D', 'LastName': 'Darnell', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': ""O'Connor"", 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Russo', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Ingraham', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sandgren', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Zatzick', 'Affiliation': ""Dr. Darnell, Dr. Russo, Dr. Wang, Ms. Ingraham, Ms. Sandgren, and Dr. Zatzick are with the Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (e-mail: darnelld@uw.edu ). Dr. O'Connor is with the Department of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, Kentucky. Dr. Wagner is with the Department of Mental Health, Portland Department of Veterans Affairs Medical Center, Portland, Oregon.""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201500458'] 1379,29043412,Randomized study of etirinotecan pegol versus irinotecan as second-line treatment for metastatic colorectal cancer.,"PURPOSE Etirinotecan pegol (EP) is a long-acting topoisomerase-I inhibitor designed to provide sustained exposure to SN-38 (active metabolite of irinotecan). This phase II study compared EP versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC). METHODS Patients were randomized to EP 145 mg/m 2 or irinotecan 350 mg/m 2 Q21d until disease progression/unacceptable toxicity. The primary endpoint was progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1). RESULTS The study was terminated before completing accrual due to evolving standards of care. Eighty-three patients were randomized. Median PFS was longer with EP versus irinotecan (4.0 versus 2.8 months, respectively; HR 0.65; 95% CI 0.40-1.04; P = 0.07). Six-month PFS rates were 32.8 and 15.4%, respectively. Median OS was 9.6 and 8.4 months in EP and irinotecan arms, respectively (HR 0.91; 95% CI 0.56-1.49). ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018). The most common grade-3/4 adverse events for EP and irinotecan were diarrhea (21 vs 20%), neutropenia (10 vs 22%), abdominal pain (14 vs 5%), nausea (14 vs 2%), and vomiting (12 vs 7%), respectively. CONCLUSION EP is active and safe for second-line treatment of KRAS-mutant, irinotecan-naïve mCRC.",2017,"ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018).","['metastatic colorectal cancer', 'Patients', 'Eighty-three patients were randomized']","['EP versus irinotecan', 'etirinotecan pegol versus irinotecan', 'EP 145\xa0mg/m 2 or irinotecan 350\xa0mg/m 2 Q21d until disease progression/unacceptable toxicity']","['abdominal pain', 'vomiting', 'Six-month PFS rates', 'nausea', 'ORRs', 'Median OS', 'median DOR', 'neutropenia', 'diarrhea', 'progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1', 'Median PFS']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C3659087', 'cui_str': 'etirinotecan pegol'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}]",83.0,0.0631619,"ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018).","[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'USC Norris Comprehensive Cancer Center, 1441 Eastlake Ave Rm 3456, Los Angeles, CA, 90089-9173, USA. lenz@med.usc.edu.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Philip', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, 4th Fl, HWCRC 4100 John R Detroit, Detroit, MI, 48201, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Wilmslow Road, Manchester, M20 4BX, UK.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Kolevska', 'Affiliation': 'Kaiser Permanente Medical Center, 2nd Floor, Hallway C, 975 Sereno Drive, Vallejo, CA, 94589, USA.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Mukherjee', 'Affiliation': 'Chittaranjan National Cancer Institute, 37 Shyama Prasad Mukherjee Road, Bhawanipur, Kolkata, West Bengal, 700026, India.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'ANCHOR Unit Clinic D, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bondarde', 'Affiliation': 'Shatabdi Super Specialty Hospital, Suyojit City Center, Mumbai Naka, Nashik, 422 005, India.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Dobbs', 'Affiliation': 'Tennessee Cancer Specialists, 1415 Old Weisgarser Road, Knoxville, TN, 37909-1292, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Hoch', 'Affiliation': 'Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Hannah', 'Affiliation': 'Nektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Berkowitz', 'Affiliation': 'UCLA Geffen School of Medicine, 201 S. Buena Vista Street, Suite 200, Burbank, CA, 91505, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-017-3438-y'] 1380,31594690,GLPG2737 in lumacaftor/ivacaftor-treated CF subjects homozygous for the F508del mutation: A randomized phase 2A trial (PELICAN).,"BACKGROUND Triple combinations of cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulators demonstrate enhanced clinical efficacy in CF patients with F508del mutation, compared with modest effects of dual combinations. GLPG2737 was developed as a novel corrector for triple combination therapy. METHODS This multicenter, randomized, double-blind, placebo-controlled, phase 2a study evaluated GLPG2737 in F508del homozygous subjects who had been receiving lumacaftor 400mg/ivacaftor 250mg for ≥12weeks. The primary outcome was change from baseline in sweat chloride concentration. Other outcomes included assessment of pulmonary function, respiratory symptoms, safety, tolerability, and pharmacokinetics. RESULTS Between November 2017 and April 2018, 22 subjects were enrolled and randomized to oral GLPG2737 (75mg; n=14) or placebo (n=8) capsules twice daily for 28days. A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L [95% confidence interval (CI) -36.0, -3.2], p=.0210). The absolute improvement, as assessed by least-squares-mean difference in change from baseline, in forced expiratory volume in 1s (percent predicted) at day 28 for GLPG2737 versus placebo was 3.4% (95% CI -0.5, 7.3). Respiratory symptoms in both groups remained stable. Mild/moderate adverse events occurred in 10 (71.4%) and 8 (100%) subjects receiving GLPG2737 and placebo, respectively. Lower exposures of GLPG2737 (and active metabolite M4) were observed than would be expected if administered alone (as lumacaftor induces CYP3A4). Lumacaftor and ivacaftor exposures were as expected. CONCLUSIONS GLPG2737 was well tolerated and yielded significant decreases in sweat chloride concentration versus placebo in subjects homozygous for F508del receiving lumacaftor/ivacaftor, demonstrating evidence of increased CFTR activity when added to a potentiator-corrector combination. FUNDING Galapagos NV. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT03474042.",2020,A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L,"['Between November 2017 and April 2018, 22 subjects', 'CF patients with F508del mutation', 'F508del homozygous subjects who had been receiving lumacaftor 400mg/ivacaftor 250mg for ≥12weeks']","['GLPG2737', 'placebo', 'GLPG2737 versus placebo', 'oral GLPG2737']","['sweat chloride concentration', 'pulmonary function, respiratory symptoms, safety, tolerability, and pharmacokinetics', 'Respiratory symptoms', 'forced expiratory volume', 'CFTR activity', 'mean sweat chloride concentration', 'Mild/moderate adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.743982,A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'van Koningsbruggen-Rietschel', 'Affiliation': ""Cystic Fibrosis Center, Children's Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Germany. Electronic address: Silke.vanKoningsbruggen@uk-koeln.de.""}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Conrath', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Cystic Fibrosis Center Munich-West, Munich, Germany.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Cystic Fibrosis Division, Department of Pulmonary Medicine, University of Essen, University Duisburg-Essen, Ruhrlandklinik, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kempa', 'Affiliation': 'Cystic Fibrosis Center, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gleiber', 'Affiliation': 'Cystic Fibrosis Center, Department of Pulmonary Medicine, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Cystic Fibrosis Center, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hector', 'Affiliation': ""Children's Hospital of the University of Tübingen, Tübingen, Germany.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Osselaer', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Pano', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Corveleyn', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Bwirire', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Santermans', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Muller', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bellaire', 'Affiliation': 'Galapagos BV, Leiden, The Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van de Steen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.006'] 1381,31862436,Communicating health information and improving coordination with primary care (CHIIP): Rationale and design of a randomized cardiovascular health promotion trial for adult survivors of childhood cancer.,"BACKGROUND Long-term survival for children diagnosed with cancer exceeds 80%. Notably, premature cardiovascular disease has become the leading non-cancer cause of late mortality among these survivors. METHODS/DESIGN This randomized controlled trial (RCT; NCT03104543) focuses on adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment. Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes. Those with abnormal values are then enrolled in an RCT to test the efficacy of a 12-month personalized, remotely delivered survivorship care plan (SCP) intervention designed to reduce undertreatment of these three target conditions. The intervention approximates a clinical encounter and is based on chronic disease self-management strategies. RESULTS With a goal of 750, currently 342 out of 742 eligible participants approached have enrolled (46.1%). Initially, we randomized participants to different recruitment strategies, including shorter approach packets and a tiered consent, but did not find significant differences in participation rates (40.7% to 42.9%; p = .95). Subsequently, slightly greater participation was seen with larger upfront unconditional incentive checks ($50 vs. $25: 50.7% vs. 44.1%; p = .10). Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive. CONCLUSION The overall study will determine if a National Academy of Medicine-recommended SCP intervention can improve cardiovascular outcomes among long-term survivors of childhood cancer. Modifications to the recruitment strategy may improve participation rates over time.",2020,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive. ","['Participants undergo a home-based evaluation of blood pressure and laboratory tests to determine the prevalence of undiagnosed and/or undertreated hypertension, dyslipidemia, and diabetes', 'adult participants in the Childhood Cancer Survivor Study identified as high risk for ischemic heart disease or heart failure due to their cancer treatment', '750, currently 342 out of 742 eligible participants approached have enrolled (46.1', 'children diagnosed with cancer exceeds 80', 'adult survivors of childhood cancer']","['survivorship care plan (SCP) intervention', 'primary care (CHIIP', 'Medicine-recommended SCP intervention']","['participation rates', 'cardiovascular outcomes']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]",[],742.0,0.163255,"Overall, the financial impact of the $50 upfront incentive was cost neutral, and possibly cost-saving, vs. a $25 upfront incentive. ","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': ""Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA, United States of America. Electronic address: ericchow@uw.edu.""}, {'ForeName': 'Laura-Mae', 'Initials': 'LM', 'LastName': 'Baldwin', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Hagen', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, United States of America; Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kochar', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Nathan', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Taylor', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Tonorezos', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105915'] 1382,28727223,Effect of abacus training on executive function development and underlying neural correlates in Chinese children.,"Executive function (EF) refers to a set of cognitive abilities involved in self-regulated behavior. Given the critical role of EF in cognition, strategies for improving EF have attracted intensive attention in recent years. Previous studies have explored the effects of abacus-based mental calculation (AMC) training on several cognitive abilities. However, it remains unclear whether AMC training affects EF and its neural correlates. In this study, participants were randomly assigned to AMC or control groups upon starting primary school. The AMC group received 2 h AMC training every week, while the control group did not have any abacus experience. Neural activity during an EF task was examined using functional MRI for both groups in their 4 th and 6 th grades. Our results showed that the AMC group performed better and faster than the control group in both grades. They also had lower activation in the frontoparietal reigons than the control group in the 6 th grade. From the 4 th to the 6 th grade, the AMC group showed activation decreases in the frontoparietal regions, while the control group exhibited an opposite pattern. Furthermore, voxel-wise regression analyses revealed that better performance was associated with lower task-relevant brain activity in the AMC group but associated with greater task-relevant brain activity in the control group. These results suggest that long-term AMC training, with calculation ability as its original target, may improve EF and enhance neural efficiency of the frontoparietal regions during development. Hum Brain Mapp 38:5234-5249, 2017. © 2017 Wiley Periodicals, Inc.",2017,They also had lower activation in the frontoparietal reigons than the control group in the 6 th grade.,['Chinese children'],"['abacus training', 'abacus-based mental calculation (AMC) training', 'AMC']","['task-relevant brain activity', 'executive function development', 'Neural activity', 'lower task-relevant brain activity']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3878323', 'cui_str': 'Abacus'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0382121', 'cui_str': '(3H)-AMC'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.018665,They also had lower activation in the frontoparietal reigons than the control group in the 6 th grade.,"[{'ForeName': 'Chunjie', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Psychology, Suzhou University of Science and Technology, Suzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuqiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Bio-X Laboratory, Department of Physics, Zhejiang University, Hangzhou, China.'}]",Human brain mapping,['10.1002/hbm.23728'] 1383,28594150,Cortical thickness is not associated with current depression in a clinical treatment study.,"BACKGROUND Reduced cortical thickness is a candidate biological marker of depression, although findings are inconsistent. This could reflect analytic heterogeneity, such as use of region-wise cortical thickness based on the Freesurfer Desikan-Killiany (DK) atlas or surface-based morphometry (SBM). The Freesurfer Destrieux (DS) atlas (more, smaller regions) has not been utilized in depression studies. This could also reflect differential gender and age effects. METHODS Cortical thickness was collected from 170 currently depressed adults and 52 never-depressed adults. Visually inspected and approved Freesurfer-generated surfaces were used to extract cortical thickness estimates according to the DK atlas (68 regions) and DS atlas (148 regions) for region-wise analysis (216 total regions) and for SBM. RESULTS Overall, except for small effects in a few regions, the two region-wise approaches generally failed to discriminate depressed adults from nondepressed adults or current episode severity. Differential effects by age and gender were also rare and small in magnitude. Using SBM, depressed adults showed a significantly thicker cluster in the left supramarginal gyrus than nondepressed adults (P = 0.047) but there were no associations with current episode severity. CONCLUSIONS Three analytic approaches (i.e., DK atlas, DS atlas, and SBM) converge on the notion that cortical thickness is a relatively weak discriminator of current depression status. Differential age and gender effects do not appear to represent key moderators. Robust associations with demographic factors will likely hinder translation of cortical thickness into a clinically useful biomarker. Hum Brain Mapp, 2017. © 2017 Wiley Periodicals, Inc. Hum Brain Mapp 38:4370-4385, 2017. © 2017 Wiley Periodicals, Inc.",2017,"Overall, except for small effects in a few regions, the two region-wise approaches generally failed to discriminate depressed adults from nondepressed adults or current episode severity.",['170 currently depressed adults and 52 never-depressed adults'],[],[],"[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],170.0,0.0304005,"Overall, except for small effects in a few regions, the two region-wise approaches generally failed to discriminate depressed adults from nondepressed adults or current episode severity.","[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Perlman', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bartlett', 'Affiliation': 'Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeLorenzo', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Ogden', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Oquendo', 'Affiliation': 'New York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weyandt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Malchow', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}]",Human brain mapping,['10.1002/hbm.23664'] 1384,28504364,Mindfulness meditation regulates anterior insula activity during empathy for social pain.,"Mindfulness has been shown to reduce stress, promote health, and well-being, as well as to increase compassionate behavior toward others. It reduces distress to one's own painful experiences, going along with altered neural responses, by enhancing self-regulatory processes and decreasing emotional reactivity. In order to investigate if mindfulness similarly reduces distress and neural activations associated with empathy for others' socially painful experiences, which might in the following more strongly motivate prosocial behavior, the present study compared trait, and state effects of long-term mindfulness meditation (LTM) practice. To do so we acquired behavioral data and neural activity measures using functional magnetic resonance imaging (fMRI) during an empathy for social pain task while manipulating the meditation state between two groups of LTM practitioners that were matched with a control group. The results show increased activations of the anterior insula (AI) and anterior cingulate cortex (ACC) as well as the medial prefrontal cortex and temporal pole when sharing others' social suffering, both in LTM practitioners and controls. However, in LTM practitioners, who practiced mindfulness meditation just prior to observing others' social pain, left AI activation was lower and the strength of AI activation following the mindfulness meditation was negatively associated with trait compassion in LTM practitioners. The findings suggest that current mindfulness meditation could provide an adaptive mechanism in coping with distress due to the empathic sharing of others' suffering, thereby possibly enabling compassionate behavior. Hum Brain Mapp 38:4034-4046, 2017. © 2017 Wiley Periodicals, Inc.",2017,"The results show increased activations of the anterior insula (AI) and anterior cingulate cortex (ACC) as well as the medial prefrontal cortex and temporal pole when sharing others' social suffering, both in LTM practitioners and controls.",[],"['functional magnetic resonance imaging (fMRI', 'current mindfulness meditation', 'Mindfulness meditation']","['activations of the anterior insula (AI) and anterior cingulate cortex (ACC', 'emotional reactivity', 'strength of AI activation', 'social pain, left AI activation']",[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C0228259', 'cui_str': 'Anterior insula (body structure)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",,0.0161893,"The results show increased activations of the anterior insula (AI) and anterior cingulate cortex (ACC) as well as the medial prefrontal cortex and temporal pole when sharing others' social suffering, both in LTM practitioners and controls.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Laneri', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University Marburg, Rudolf-Bultmann Strasse 8, Marburg, 35039, Germany.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Krach', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Social Neuroscience Lab, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany.'}, {'ForeName': 'Frieder M', 'Initials': 'FM', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Social Neuroscience Lab, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kanske', 'Affiliation': 'Department of Social Neuroscience, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstr. 1a, Leipzig, 04103, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Schuster', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University Marburg, Rudolf-Bultmann Strasse 8, Marburg, 35039, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University Marburg, Rudolf-Bultmann Strasse 8, Marburg, 35039, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Müller-Pinzler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Social Neuroscience Lab, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany.'}]",Human brain mapping,['10.1002/hbm.23646'] 1385,31488360,"Health-related quality of life and neurocognitive functioning with lomustine-temozolomide versus temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): a randomised, multicentre, open-label, phase 3 trial.","BACKGROUND The CeTeG/NOA-09 trial showed significantly longer overall survival with combined lomustine-temozolomide therapy compared with standard temozolomide for patients with glioblastoma with methylated MGMT promoter. The trial also aimed to investigate the effect of lomustine-temozolomide therapy on health-related quality of life (HRQOL) and neurocognitive function, which we report here. METHODS In this randomised, multicentre, open-label, phase 3 trial, newly diagnosed, chemoradiotherapy-naive patients with MGMT-methylated glioblastoma, aged 18-70 years, with a Karnofsky performance score of 70% or higher, were recruited and enrolled at 17 university hospitals in Germany. Patients received standard radiotherapy (60 Gy) and were randomly assigned (1:1, stratified by centre by allocating complete blocks of six to a centre, without masking) to either six 6-week courses of oral combined lomustine (100 mg/m 2 on day 1) plus temozolomide (100-200 mg/m 2 on days 2-6) or standard oral temozolomide (75 mg/m 2 daily during radiotherapy plus six 4-week courses of temozolomide [150-200 mg/m 2 ] on days 1-5, every 4 weeks). The primary endpoint was overall survival. HRQOL, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 and the EORTC brain cancer module (BN20); and neurocognitive function, assessed using the Mini Mental State Examination (MMSE), plus a neurocognitive test battery (NOA-07), including Trail Making Test A and B (TMT-A and B), working memory tests, and tests for lexical (Controlled Oral Word Association [COWA]) and semantic verbal fluency, were secondary endpoints analysed in the modified intention-to-treat population (mITT; all randomly assigned patients who received at least one dose of study chemotherapy). We used linear mixed-model analyses to investigate differences between treatment groups regarding HRQOL (clinically relevant ≥10 points) and MMSE scores (clinically relevant ≥3 points). The trial is registered with ClinicalTrials.gov, NCT01149109. FINDINGS Between June 17, 2011 and April 8, 2014, 141 patients were randomly assigned and 129 patients began treatment and were included in the mITT population (63 in the temozolomide and 66 in the lomustine-temozolomide group). Median follow-up for HRQOL (the item global health) was 19·4 months (IQR 7·8-38·6), for MMSE was 15·3 months (4·1-29·6), and for COWA was 11·0 months (0-27·5). We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30 [95% CI -0·23 to 0·83]; p=0·26). Differences in MMSE were in favour of the temozolomide group (difference -0·11 [95% CI -0·19 to -0·03]; p=0·0058) but were not clinically relevant (1·76/30 points over 4 years). We found no significant difference between the groups in any subtest of the neurocognitive test battery (difference for COWA 0·04 [95% CI -0·01 to 0·09]; p=0·14). INTERPRETATION The absence of systematic and clinically relevant changes in HRQOL and neurocognitive function combined with the survival benefit of lomustine-temozolomide versus temozolomide alone suggests that a long-term net clinical benefit exists for patients with newly diagnosed glioblastoma with methylation of the MGMT promoter and supports the use of lomustine-temozolomide as a treatment option for these patients. FUNDING German Federal Ministry of Education and Research.",2019,We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30,"['patients with glioblastoma with methylated MGMT promoter', 'Between June 17, 2011 and April 8, 2014, 141 patients were randomly assigned and 129 patients began treatment and were included in the mITT population (63 in the', 'newly diagnosed, chemoradiotherapy-naive patients with MGMT-methylated glioblastoma, aged 18-70 years, with a Karnofsky performance score of 70% or higher, were recruited and enrolled at 17 university hospitals in Germany', 'patients with newly diagnosed glioblastoma with methylation of the MGMT promoter', 'patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09', 'group']","['temozolomide', 'standard temozolomide', 'standard oral temozolomide', 'oral combined lomustine', 'lomustine-temozolomide versus temozolomide', 'lomustine-temozolomide therapy', 'lomustine-temozolomide', 'standard radiotherapy (60 Gy']","['HRQOL, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 and the EORTC brain cancer module (BN20); and neurocognitive function, assessed using the Mini Mental State Examination (MMSE), plus a neurocognitive test battery (NOA-07), including Trail Making Test A and B (TMT-A and B), working memory tests, and tests for lexical (Controlled Oral Word Association [COWA]) and semantic verbal fluency', 'overall survival', 'MMSE', 'HRQOL', 'global health 0·30', 'health-related quality of life (HRQOL) and neurocognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0153633', 'cui_str': 'Brain Cancer'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",141.0,0.416338,We found no significant impairment regarding any item of HRQOL in the lomustine-temozolomide group (difference between the groups for global health 0·30,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Weller', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Theophilos', 'Initials': 'T', 'LastName': 'Tzaridis', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Mack', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Joachim Peter', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schlegel', 'Affiliation': 'Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hau', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Krex', 'Affiliation': 'Department of Neurosurgery, University of Dresden, Dresden, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grauer', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goldbrunner', 'Affiliation': 'Department of Neurosurgery, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, University of Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Neurology and Wilhelm Sander Neurooncology Unit, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Seidel', 'Affiliation': 'Department of Radiation Oncology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Interdisciplinary Division of Neurooncology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Brehmer', 'Affiliation': 'Department of Neurosurgery, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Department of Internal Medicine, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Galldiks', 'Affiliation': 'Department of Neurology, University of Cologne, Cologne, Germany; Institute of Neuroscience and Medicine, Forschungszentrum Juelich, Juelich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schaub', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Sied', 'Initials': 'S', 'LastName': 'Kebir', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Stummer', 'Affiliation': 'Department of Neurosurgery, University of Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Coch', 'Affiliation': 'Study Center Bonn, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Glas', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and West German Cancer Center, German Cancer Consortium, Partner Site Essen, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany. Electronic address: ulrich.herrlinger@ukbonn.de.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology and Center of Integrated Oncology, University Hospital Bonn, Bonn, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30502-9'] 1386,31847628,Local ultra-low-dose estriol gel treatment of vulvo-vaginal atrophy: efficacy and safety of long-term treatment.,"Vulvo-vaginal atrophy (VVA) is a chronic condition affecting many postmenopausal women. Local estrogen treatment is recommended. Evaluating efficacy and safety of long-term VVA treatment with ultra-low-dose estriol gel, 120 postmenopausal VVA women were enrolled in a prospective study. They received the first cycle of 1 g/day vaginal gel containing 50 µg estriol for 3 weeks and then twice a week for 12 weeks. Moderate or severe VVA women received a second treatment cycle reaching treatment of 30 weeks. Vaginal pH measurement, subjective symptoms, and objective signs assessment of VVA, endometrial thickness and adverse events (AE) were recorded. Of the 99 women, completing the first phase, 43% experienced a complete VVA symptom relief, and 65% presented a milder VVA degree. After 30 weeks, VVA signs significantly improved ( p <.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller's test, flattening of folds and vaginal pH significantly improved ( p <.01). At study endpoint, none of the patients had severe VVA, 93% had a positive response, 75% had a complete symptom, and sign resolution. No treatment-related endometrial AE were observed. Postmenopausal VVA long term-treatment with ultra-low-dose estriol vaginal gel is safe and effective.",2020,"After 30 weeks, VVA signs significantly improved ( p <.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller's test, flattening of folds and vaginal pH significantly improved ( p <.01).","['vulvo-vaginal atrophy', 'postmenopausal women', '120 postmenopausal VVA women', 'Moderate or severe VVA women']","['ultra-low-dose estriol vaginal gel', 'Vulvo-vaginal atrophy (VVA', 'long-term VVA treatment with ultra-low-dose estriol gel', 'Local ultra-low-dose estriol gel']","['complete symptom, and sign resolution', 'Vaginal pH measurement, subjective symptoms, and objective signs assessment of VVA, endometrial thickness and adverse events (AE', 'complete VVA symptom relief', 'endometrial AE', ""total objective symptom evaluation including Schiller's test, flattening of folds and vaginal pH"", 'VVA signs']","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]",120.0,0.0261078,"After 30 weeks, VVA signs significantly improved ( p <.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller's test, flattening of folds and vaginal pH significantly improved ( p <.01).","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Villa', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tagliaferri', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Inbal Dona', 'Initials': 'ID', 'LastName': 'Amar', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Cipolla', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ingravalle', 'Affiliation': 'Department of Biomedicine and Prevention, Università degli Studi di Roma Tor Vergata Facoltà di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ricciardi', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lanzone', 'Affiliation': 'Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1702016'] 1387,29081313,Is trazodone more effective than clomipramine in major depressed outpatients? A single-blind study with intravenous and oral administration.,"OBJECTIVE Some antidepressants, such as trazodone or clomipramine, can be administered intravenously in patients with major depressive disorder (MDD), with potential benefits compared to the standard oral treatment, but available data about their efficacy are limited. The present study was aimed to compare the effectiveness of trazodone and clomipramine (intravenous [i.v.] followed by oral administration). METHODS Some 42 patients with a diagnosis of MDD according to the DSM-5 were selected and treated with i.v. trazodone or clomipramine according to clinical judgment. The Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Montgomery-Åsberg Depression Rating Scale were administered at baseline, after 2 weeks, and after 6 weeks, as well as after 1 week of intravenous antidepressant administration. Raters were blinded to type of treatment. RESULTS No significant differences were found between treatment groups in terms of effectiveness at endpoint. Borderline statistical significance was found in terms of number of responders in favor of trazodone. In addition, patients treated with trazodone reported fewer total side effects than those treated with clomipramine. CONCLUSION Both i.v. trazodone and clomipramine are rapid and effective options for improving depressive symptoms, although trazodone appears to be tolerated better. Further studies with larger samples and double-blind conditions are warranted to confirm our results.",2019,"In addition, patients treated with trazodone reported fewer total side effects than those treated with clomipramine. ","['patients with major depressive disorder (MDD', '42 patients with a diagnosis of MDD according to the DSM-5']","['trazodone and clomipramine', 'trazodone and clomipramine (intravenous [i.v.] followed by oral administration', 'trazodone', 'clomipramine', 'trazodone or clomipramine']","['total side effects', 'Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0009010', 'cui_str': 'Clomipramine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",42.0,0.0146735,"In addition, patients treated with trazodone reported fewer total side effects than those treated with clomipramine. ","[{'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Buoli', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rovera', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'Sara Maria', 'Initials': 'SM', 'LastName': 'Pozzoli', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cremaschi', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Caldiroli', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}, {'ForeName': 'A Carlo', 'Initials': 'AC', 'LastName': 'Altamura', 'Affiliation': ""Department of Psychiatry,University of Milan,Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico,Milan,Italy.""}]",CNS spectrums,['10.1017/S1092852917000773'] 1388,31595830,Social anxiety is associated with impaired memory for imagined social events with positive outcomes.,"Cognitive models of social anxiety disorder suggest that memory biases for negative social information contribute to symptoms of social anxiety (SA). However, it remains unclear whether memory biases in SA are related to social information, specifically, and if so, whether the valence of such information would moderate memory performance. In the present study, 197 community participants were randomised to imagine themselves as the central character in either 10 social or 10 non-social scenarios. In both conditions, half of the scenarios ended with objectively positive outcomes and half ended with objectively negative outcomes. Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively. Thus, the impact of SA on memory performance depended on how social information was framed, with higher SA related to poorer memory for positive social experiences. These context-specific effects contribute to the growing literature on positivity deficits in SA.",2020,"Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively.",['197 community participants were randomised to imagine themselves as the central character in either 10 social or 10 non-social scenarios'],[],"['Social anxiety', 'social anxiety (SA', 'higher trait SA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007952', 'cui_str': 'Character'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",197.0,0.0157215,"Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}]",Cognition & emotion,['10.1080/02699931.2019.1675596'] 1389,30866175,A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone.,"OBJECTIVE To study radiation exposure to the primary operator during diagnostic cardiac catheterizations using a radio-dense RAD BOARD® radial access arm board. BACKGROUND The use of radial access for catheterization in the United States has increased from 1% in 2007 to 41% in 2018. Compared to femoral access, operator radiation exposure from radial access is similar or higher. The RAD BOARD radio-dense radial access arm board has been marketed as reducing radiation to operators by 44%. MATERIALS AND METHODS We randomized 265 patients undergoing catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD in addition to pelvic drape (board group). Operator radiation exposure was measured using Landauer Microstar nanoDot™ badges worn by the operator. RESULTS Board and nonboard groups were similar with respect to demographic and procedural variables. Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001). In sub-group analyses, radiation doses were higher in the board group compared to the nonboard group in patients across all body mass index groups (P < 0.03). In multivariate analysis, operator dose correlated with use of the RAD BOARD more closely than any other variable (P < 0.001). Post hoc analysis of the table setup with RAD BOARD revealed that use of RAD BOARD prevented placement of a shield normally inserted into the top of the standard below-table shield. CONCLUSION RAD BOARD with the pelvic shield was associated with higher radiation exposure to the operator compared with pelvic shield alone, likely due to inability to use standard radiation shielding along with the RAD BOARD.",2020,"Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001).",['265 patients undergoing'],"['RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone', 'catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD']",['Mean operator dose per case'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",265.0,0.0793785,"Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001).","[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Suryadevara', 'Affiliation': 'Department of Cardiology, Harton Regional Medical Center, Tullahoma, Tennessee.'}, {'ForeName': 'Eddie D', 'Initials': 'ED', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Scott', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Nordberg', 'Affiliation': 'Department of Biomedical and Translational Informatics, Geisinger Health System, Danville, Pennsylvania.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Blankenship', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28190'] 1390,32412097,Comparison of the efficacy of electroconvulsive therapy (ECT) plus agomelatine to ECT plus placebo in treatment-resistant depression.,"OBJECTIVE Electroconvulsive therapy (ECT) is commonly used to treat patients with treatment-resistant depression. We aimed to investigate whether combining an antidepressant agent with ECT might enhance therapeutic efficacy and prevent early relapse. METHOD During the acute ECT phase, patients (N = 97) with treatment-resistant depression were randomized to receive ECT plus agomelatine 50 mg/day (n = 48) or ECT plus placebo (n = 49). Symptom severity measures, including the 17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT, were assessed regularly. Remission was defined as a HAMD-17 score ≤7. If patients achieved post-ECT remission, they were prescribed agomelatine 50 mg/day and participated in a 12-week follow-up trial. HAMD-17 was rated at 4-week intervals. Relapse was defined as a HAMD-17 score ≥14, or rehospitalization for a psychiatric reason. RESULTS The two treatment groups were comparable at (i) baseline variables; (ii) score changes in all symptom measures, functional impairment, quality of life, and neuropsychological tests; (iii) frequency of adverse events and attitudes toward ECT; and (iv) post-ECT response/remission rates. There were no statistically significant differences following ECT in relapse rates and time to relapse between these two groups. CONCLUSION Adding agomelatine to ECT yielded comparable response/remission rates to ECT without agomelatine in the acute ECT phase. Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course. More research is needed to guide clinical recommendations.",2020,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"['patients with treatment-resistant depression', 'patients (N = 97) with treatment-resistant depression']","['ECT', 'ECT plus agomelatine to ECT plus placebo', 'ECT plus agomelatine', 'Electroconvulsive therapy (ECT', 'ECT plus placebo']","['17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT', 'response/remission rates', 'Remission', 'Relapse', 'symptom measures, functional impairment, quality of life, and neuropsychological tests, 3) frequency of adverse events and attitudes toward ECT, and 4) post-ECT response/remission rates', 'relapse rates and time to relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.124056,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"[{'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-C', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-R', 'Initials': 'WR', 'LastName': 'Cai', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13183'] 1391,28608601,Brain structural properties predict psychologically mediated hypoalgesia in an 8-week sham acupuncture treatment for migraine.,"Neuroimaging studies described brain structural changes that comprise the mechanisms underlying individual differences in migraine development and maintenance. However, whether such interindividual variability in migraine was observed in a pretreatment scan is a predisposition for subsequent hypoalgesia to placebo treatment that remains largely unclear. Using T1-weighted imaging, we investigated this issue in 50 healthy controls (HC) and 196 patients with migraine without aura (MO). An 8-week double-blinded, randomized, placebo-controlled acupuncture was used, and we only focused on the data from the sham acupuncture group. Eighty patients participated in an 8-weeks sham acupuncture treatment, and were subdivided (50% change in migraine days from baseline) into recovering (MOr) and persisting (MOp) patients. Optimized voxel-based morphometry (VBM) and functional connectivity analysis were performed to evaluate brain structural and functional changes. At baseline, MOp and MOr had similar migraine activity, anxiety and depression; reduced migraine days were accompanied by decreased anxiety in MOr. In our findings, the MOr group showed a smaller volume in the left medial prefrontal cortex (mPFC), and decreased mPFC-related functional connectivity was found in the default mode network. Additionally, the reduction in migraine days after placebo treatment was significantly associated with the baseline gray matter volume of the mPFC which could also predict post-treatment groups with high accuracy. It indicated that individual differences for the brain structure in the pain modulatory system at baseline served as a substrate on how an individual facilitated or diminished hypoalgesia responses to placebo treatment in migraineurs. Hum Brain Mapp 38:4386-4397, 2017. © 2017 Wiley Periodicals, Inc.",2017,"Additionally, the reduction in migraine days after placebo treatment was significantly associated with the baseline gray matter volume of the mPFC which could also predict post-treatment groups with high accuracy.","['50 healthy controls (HC) and 196 patients with migraine without aura (MO', 'Eighty patients participated in an']","['placebo-controlled acupuncture', '8-weeks sham acupuncture', 'placebo']","['migraine activity, anxiety and depression; reduced migraine days', 'hypoalgesia responses', 'anxiety in MOr', 'left medial prefrontal cortex (mPFC), and decreased mPFC-related functional connectivity']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338480', 'cui_str': 'Migraine without Aura'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",80.0,0.116722,"Additionally, the reduction in migraine days after placebo treatment was significantly associated with the baseline gray matter volume of the mPFC which could also predict post-treatment groups with high accuracy.","[{'ForeName': 'Jixin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, People's Republic of China.""}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, People's Republic of China.""}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, People's Republic of China.""}, {'ForeName': 'Wanghuan', 'Initials': 'W', 'LastName': 'Dun', 'Affiliation': ""Department of Medical Imaging, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Imaging, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Center for Brain Imaging, School of Life Science and Technology, Xidian University, Xi'an, People's Republic of China.""}]",Human brain mapping,['10.1002/hbm.23667'] 1392,31590702,Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.,"BACKGROUND Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence's guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017; 8 :CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. OBJECTIVES To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. DESIGN A multicentre, randomised, blinded, placebo-controlled trial. SETTING Twenty-seven maternity units in the UK. PARTICIPANTS Women who had an operative vaginal birth at ≥ 36 weeks' gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. INTERVENTIONS A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. MAIN OUTCOME MEASURES Primary outcome - confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes - severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. RESULTS Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). LIMITATIONS The follow-up rate achieved for most secondary outcomes was 76%. CONCLUSIONS This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. TRIAL REGISTRATION Current Controlled Trials ISRCTN11166984. FUNDING This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.",2019,"Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69).","['Between March 2016 and June 2018', '3427 women were randomised: 1719 to the antibiotic arm and 1708 to the', ""Women who had an operative vaginal birth at ≥\u200936 weeks' gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics"", 'Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the', 'Twenty-seven maternity units in the UK']","['Antibiotic prophylaxis', 'prophylactic antibiotic', 'Intravenous co-amoxiclav', 'placebo', 'prophylactic antibiotics', 'operative vaginal birth (forceps or ventouse/vacuum extraction', 'intravenous co-amoxiclav (1\u2009g of amoxicillin/200\u2009mg of clavulanic acid) or placebo (sterile saline']","['suspected infection within 6 weeks of giving birth', 'serious adverse events', 'severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0042225', 'cui_str': 'Delivery, Vacuum Extraction'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0240717', 'cui_str': 'Perineal pain (finding)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0150301', 'cui_str': 'Perineal care (regime/therapy)'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0560879', 'cui_str': 'Ability to sit (observable entity)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038940', 'cui_str': 'Surgical Wound Dehiscence'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",3420.0,0.615428,"Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69).","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Department of Microbiology, Birmingham Women's & Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Department of Obstetrics and Gynaecology, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Aethele', 'Initials': 'A', 'LastName': 'Khunda', 'Affiliation': ""Department of Women's Health, James Cook University Hospital, Middlesbrough, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Moore', 'Affiliation': ""Department of Microbiology, Birmingham Women's & Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mottram', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Owino', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, King's Health Partners, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Tuffnell', 'Affiliation': ""Department of Women's Health, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23540'] 1393,31582355,"Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.","BACKGROUND Chemotherapy for patients with advanced oesophageal squamous cell carcinoma offers poor long-term survival prospects. We report the final analysis from our study of the immune checkpoint PD-1 inhibitor nivolumab versus chemotherapy in patients with previously treated advanced oesophageal squamous cell carcinoma. METHODS We did a multicentre, randomised, open-label, phase 3 trial (ATTRACTION-3) at 90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA. We enrolled patients aged 20 years and older with unresectable advanced or recurrent oesophageal squamous cell carcinoma (regardless of PD-L1 expression), at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, a baseline Eastern Cooperative Oncology Group performance status of 0-1, and who were refractory or intolerant to one previous fluoropyrimidine-based and platinum-based chemotherapy and had a life expectancy of at least 3 months. Patients were randomly assigned (1:1) to either nivolumab (240 mg for 30 min every 2 weeks) or investigator's choice of chemotherapy (paclitaxel 100 mg/m 2 for at least 60 min once per week for 6 weeks then 1 week off; or docetaxel 75 mg/m 2 for at least 60 min every 3 weeks), all given intravenously. Treatment continued until disease progression assessed by the investigator per RECIST version 1.1 or unacceptable toxicity. Randomisation was done using an interactive web response system with a block size of four and stratified according to geographical region (Japan vs rest of the world), number of organs with metastases, and PD-L1 expression. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival, defined as the time from randomisation until death from any cause, in the intention-to-treat population that included all randomly assigned patients. Safety was assessed in all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, number NCT02569242, and follow-up for long-term outcomes is ongoing. FINDINGS Between Jan 7, 2016, and May 25, 2017, we assigned 419 patients to treatment: 210 to nivolumab and 209 to chemotherapy. At the time of data cutoff on Nov 12, 2018, median follow-up for overall survival was 10·5 months (IQR 4·5-19·0) in the nivolumab group and 8·0 months (4·6-15·2) in the chemotherapy group. At a minimum follow-up time (ie, time from random assignment of the last patient to data cutoff) of 17·6 months, overall survival was significantly improved in the nivolumab group compared with the chemotherapy group (median 10·9 months, 95% CI 9·2-13·3 vs 8·4 months, 7·2-9·9; hazard ratio for death 0·77, 95% CI 0·62-0·96; p=0·019). 38 (18%) of 209 patients in the nivolumab group had grade 3 or 4 treatment-related adverse events compared with 131 (63%) of 208 patients in the chemotherapy group. The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group. Five deaths were deemed treatment-related: two in the nivolumab group (one each of interstitial lung disease and pneumonitis) and three in the chemotherapy group (one each of pneumonia, spinal cord abscess, and interstitial lung disease). INTERPRETATION Nivolumab was associated with a significant improvement in overall survivaland a favourable safety profile compared with chemotherapy in previously treated patients with advanced oesophageal squamous cell carcinoma, and might represent a new standard second-line treatment option for these patients. FUNDING ONO Pharmaceutical Company and Bristol-Myers Squibb.",2019,The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group.,"['patients with previously treated advanced oesophageal squamous cell carcinoma', '90 hospitals and cancer centres in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA', 'patients with advanced oesophageal squamous cell carcinoma', 'Between Jan 7, 2016, and May 25, 2017, we assigned 419 patients to treatment: 210 to nivolumab and 209 to chemotherapy', 'patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous', 'enrolled patients aged 20 years and older with unresectable advanced or recurrent oesophageal squamous cell carcinoma (regardless of PD-L1 expression), at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors']","['docetaxel', 'Nivolumab versus chemotherapy', 'chemotherapy (paclitaxel', 'chemotherapy', 'fluoropyrimidine-based and platinum-based chemotherapy', 'nivolumab', 'immune checkpoint PD-1 inhibitor nivolumab versus chemotherapy']","['Safety', 'overall survival', 'grade 3 or 4 treatment-related adverse events', 'neutrophil count', 'overall survival, defined as the time from randomisation until death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",419.0,0.302424,The most frequent grade 3 or 4 treatment-related adverse events were anaemia (four [2%]) in the nivolumab group and decreased neutrophil count (59 [28%]) in the chemotherapy group.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: kenkato@ncc.go.jp.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medical Oncology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Chen-Yuan', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology and Oncology, China Medical University Hospital and School of Pharmacy, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Gastroenterological Chemotherapy Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Internal Medicine, Keio Cancer Center, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Surgery, Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Chueh-Chuan', 'Initials': 'CC', 'LastName': 'Yen', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Oncology, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Xynos', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Kodani', 'Affiliation': 'Department of Oncology, ONO Pharmaceutical Company, Osaka, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30626-6'] 1394,28064421,Impact of a Randomized Controlled Trial to Reduce Bedsharing on Breastfeeding Rates and Duration for African-American Infants.,"Bedsharing is associated with both increased breastfeeding and increased risk of sudden and unexpected infant deaths. The objective was to determine impact of sleep location and counseling about sleep location on breastfeeding exclusivity and duration in African-Americans. 1194 mothers of newborns were randomized to receive messaging emphasizing either safe sleep practices to reduce SIDS risk or safe sleep practices to prevent SIDS/suffocation. Mothers completed four interviews in the 6 months after delivery. The most common sleep arrangement was roomsharing without bedsharing (""roomsharing""). Duration of any breastfeeding was 6.1 and 5.3 weeks for infants who usually bedshared or roomshared, respectively (p = 0.01). Duration of exclusive breastfeeding was 3.0 and 1.6 weeks for infants who usually bedshared or roomshared, respectively (p < 0.001). Group assignment did not affect breastfeeding duration. The most common sleep arrangement for African-American infants <6 months was roomsharing. An intervention designed to discourage bedsharing did not impact breastfeeding duration.",2017,Group assignment did not affect breastfeeding duration.,"['1194 mothers of newborns', 'African-Americans', 'African-American Infants']",['messaging emphasizing either safe sleep practices to reduce SIDS risk or safe sleep practices to prevent SIDS/suffocation'],"['Breastfeeding Rates and Duration', 'Duration of any breastfeeding', 'Duration of exclusive breastfeeding', 'breastfeeding duration']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038644', 'cui_str': 'SIDS'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",,0.11235,Group assignment did not affect breastfeeding duration.,"[{'ForeName': 'Rachel Y', 'Initials': 'RY', 'LastName': 'Moon', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, University of Virginia, PO Box 800386, Charlottesville, VA, 22908, USA. rym4z@virginia.edu.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathews', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Brandi L', 'Initials': 'BL', 'LastName': 'Joyner', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Rosalind P', 'Initials': 'RP', 'LastName': 'Oden', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Center for Translational Science, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McCarter', 'Affiliation': ""Center for Translational Science, Children's National Medical Center, Washington, DC, USA.""}]",Journal of community health,['10.1007/s10900-016-0307-2'] 1395,27634692,Final analysis of the prospective WSG-AGO EC-Doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression.,,2017,,[],[],[],[],[],[],,0.0114948,,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Nitz', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany. Electronic address: ulrike.nitz@wsg-online.com.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gluz', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Kreipe', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Kates', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Moustafa', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lisboa', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mohrmann', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Augustin', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hoffmann', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Weiss', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Böhmer', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kreienberg', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Du Bois', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sattler', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thomssen', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kiechle', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jänicke', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wallwiener', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kuhn', 'Affiliation': ""Women's Clinic, Heinrich-Heine-University Duesseldorf, Duesseldorf; West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach; Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Institute of Pathology, Hannover Medical School, Hannover; Institute of Pathology, University Clinics Erlangen, Erlangen; Trium Analysis Online GmbH, Munich; Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt; Clinics Deggendorf Mammacenter Ostbayern, Deggendorf; Breast Center, St Josephs-Hospital, Wiesbaden; Women's Clinic, Kreiskrankenhaus Boeblingen, Boeblingen; Department of Obstetrics and Gynecology, Ev. Hospital Oberhausen, Oberhausen; Breast Center, University Women's Clinic Ulm, Ulm; Department of Gynecology and Oncology, Dr. Horst-Schmidt-Klinik GmbH, Wiesbaden; Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich; Breast Center, Women's Clinic and CCCLMU of the University of Munich, Munich; Department of Gynecology, University Hospital Bonn, Bonn, Germany.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw349'] 1396,31079517,Evaluation of a Community-Based Diabetes Prevention Program in Thailand: A Cluster Randomized Controlled Trial.,"OBJECTIVES Lifestyle interventions have been shown to effectively reduce the incidence of diabetes, but evidence from middle-income countries is scarce. We evaluated the effectiveness of a lifestyle program to prevent diabetes in primary-care settings in Thailand. METHODS A matched-pair cluster randomized controlled trial was conducted in 68 primary care units in 8 provinces. The primary care units were randomly assigned to intervention or control arms. Individuals aged 30 to 65 years with impaired oral glucose tolerance were recruited and followed up for 2 years. The intervention included periodic group-based activities on healthy lifestyle behaviors; the control group received a one-time education program. The primary outcome was the incidence rate of type 2 diabetes at 24 months after the intervention. RESULTS A total of 1903 individuals participated (873 in the control group and 1030 in the intervention group). At baseline, participants' characteristics did not differ between groups. After 24 months, the incidence rates (per 100 person-year) of diabetes was 12.1% (95% CI 10.7% to 13.8%) in the intervention group, and 16.6% (95% CI 14.6 to 18.8%) in the control group ( P < .001). Overall, the adjusted hazard ratio for diabetes incidence was 0.72 (95% CI 0.60 to 0.86). A mean body weight reduction of 1.5 kg was observed in the intervention group, whereas, an increase of 0.4 kg was observed in the control group ( P < .001). CONCLUSION A community-based lifestyle modification through participatory group activities can prevent or delay the incidence of diabetes among Thai populations with impaired glucose tolerance.",2019,"A mean body weight reduction of 1.5 kg was observed in the intervention group, whereas, an increase of 0.4 kg was observed in the control group ( P < .001). ","['primary care units', 'Individuals aged 30 to 65 years with impaired oral glucose tolerance were recruited and followed up for 2 years', 'diabetes among Thai populations with impaired glucose tolerance', '68 primary care units in 8 provinces', '1903 individuals participated (873 in the control group and 1030 in the intervention group', 'diabetes in primary-care settings in Thailand', 'Thailand']","['periodic group-based activities on healthy lifestyle behaviors; the control group received a one-time education program', 'Community-Based Diabetes Prevention Program', 'lifestyle program']","['adjusted hazard ratio for diabetes incidence', 'mean body weight reduction', 'incidence rates', 'incidence rate of type 2 diabetes']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",1903.0,0.125567,"A mean body weight reduction of 1.5 kg was observed in the intervention group, whereas, an increase of 0.4 kg was observed in the control group ( P < .001). ","[{'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Aekplakorn', 'Affiliation': '1 Department of Community Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Valla', 'Initials': 'V', 'LastName': 'Tantayotai', 'Affiliation': '2 Walailak University, Thasala, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Sakawduan', 'Initials': 'S', 'LastName': 'Numsangkul', 'Affiliation': '3 Khonburi Hospital, Ministry of Public Health, Khonburi District, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Nutchanat', 'Initials': 'N', 'LastName': 'Tatsato', 'Affiliation': '4 Thasala Hospital, Ministry of Public Health, Thasala District, Nakhon Si Thammarat, Thailand.'}, {'ForeName': 'Pranee', 'Initials': 'P', 'LastName': 'Luckanajantachote', 'Affiliation': '5 Samutsakhon Hospital, Ministry of Public Health, Muang District, Samutsakhon, Thailand.'}, {'ForeName': 'Thep', 'Initials': 'T', 'LastName': 'Himathongkam', 'Affiliation': '6 Theptarin Hospital, Bangkok, Thailand.'}]",Journal of primary care & community health,['10.1177/2150132719847374'] 1397,1744874,Use of an antibacterial powder spray to prevent post prostatectomy urinary infection.,"To prevent ascending urinary infection in patients following transurethral prostatectomy, we have studied the use of a topical antibacterial agent applied to the groin and external genitalia. A prospective randomized controlled trial was conducted, with 50 patients being treated by daily application of a 2% polynoxylin powder, and 50 patients acting as untreated controls. Patient age and duration of catheterization were similar in the treated and untreated groups. No significant benefit was seen in the treated cohort (P greater than 0.05) in terms of reduction in postoperative urinary infection.",1991,No significant benefit was seen in the treated cohort (P greater than 0.05) in terms of reduction in postoperative urinary infection.,"['patients following transurethral prostatectomy', '50 patients being treated by daily application of a 2% polynoxylin powder, and 50 patients acting as untreated controls']",['antibacterial powder spray'],"['Patient age and duration of catheterization', 'postoperative urinary infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0071626', 'cui_str': 'polynoxylin'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0991579', 'cui_str': 'Powder Spray'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.0275491,No significant benefit was seen in the treated cohort (P greater than 0.05) in terms of reduction in postoperative urinary infection.,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Lynch', 'Affiliation': 'Department of Urology, Bradford Royal Infirmary.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'MacDermott', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Stewart', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1398,31575503,"Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib has the potential to optimise antitumour activity while minimising myelotoxicity. We report safety and activity data for trilaciclib plus gemcitabine and carboplatin chemotherapy in patients with metastatic triple-negative breast cancer. METHODS In this randomised, open-label, multicentre, phase 2 study, adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals. Availability of diagnostic samples of tumour tissue confirming triple-negative breast cancer was a prerequisite for enrolment. Eligible patients were randomly assigned (1:1:1) by an interactive web-response system, stratified by number of previous lines of systemic therapy and the presence of liver metastases, to receive intravenous gemcitabine 1000 mg/m 2 and intravenous carboplatin (area under the concentration-time curve 2 μg × h/mL) on days 1 and 8 (group 1), gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2 on days 1 and 8 (group 2), or gemcitabine and carboplatin on days 2 and 9 plus trilaciclib on days 1, 2, 8, and 9 (group 3) of 21-day cycles. Patients continued treatment until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation by the investigator. The primary objective was to assess the safety and tolerability of combining trilaciclib with gemcitabine and carboplatin chemotherapy. The primary endpoints were duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia during the treatment period. Overall survival was included as a key secondary endpoint. Analyses were in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered with EudraCT, 2016-004466-26, and ClinicalTrials.gov, NCT02978716, and is ongoing but closed to accrual. FINDINGS Between Feb 7, 2017, and May 15, 2018, 142 patients were assessed for eligibility and 102 were randomly assigned to group 1 (n=34), group 2 (n=33), or group 3 (n=35). Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting. Median follow-up was 8·4 months (IQR 3·8-13·6) for group 1, 12·7 months (5·5-17·4) for group 2, and 12·9 months (6·7-16·8) for group 3. Data cutoff for myelosuppression endpoints was July 30, 2018, and for antitumour activity endpoints was May 17, 2019. During cycle 1, mean duration of severe neutropenia was 0·8 day (SD 2·4) in group 1, 1·5 days (3·5) in group 2, and 1·0 day (2·6) in group 3 (group 3 vs group 1 one-sided adjusted p=0·70). Severe neutropenia occurred in nine (26%) of 34 patients in group 1, 12 (36%) of 33 patients in group 2, and eight (23%) of 35 patients in group 3 (p=0·70). Overall survival was 12·6 months (IQR 5·8-15·6) in group 1, 20·1 months (9·4-not reached) in group 2, and 17·8 months (8·8-not reached) in group 3 (group 3 vs group 1 two-sided p=0·0023). The most common treatment-emergent adverse events were anaemia (22 [73%] of 34), neutropenia (21 [70%]), and thrombocytopenia (18 [60%]) in group 1; neutropenia (27 [82%] of 33), thrombocytopenia (18 [55%]) and anaemia (17 [52%]) in group 2; and neutropenia (23 [66%] of 35), thrombocytopenia (22 [63%]), and nausea (17 [49%]) in group 3. There were no treatment-related deaths. INTERPRETATION No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging. Further studies of trilaciclib in this setting are warranted. FUNDING G1 Therapeutics.",2019,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","['Between Feb 7, 2017, and May 15, 2018', '142 patients were assessed for eligibility and 102', 'adult patients (aged ≥18 years) with evaluable, biopsy-confirmed, locally recurrent or metastatic triple-negative breast cancer who had no more than two previous lines of chemotherapy were recruited from 26 sites in the USA, three in Serbia, two in North Macedonia, one in Croatia, and one in Bulgaria; sites were academic and community hospitals', 'Of all patients, 38 (37%) had received one or two lines of previous chemotherapy in the metastatic setting', 'patients with metastatic triple-negative breast cancer', 'Eligible patients']","['gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m 2 on days 1 and 8 (group 2), or gemcitabine and carboplatin', 'chemotherapy alone', 'gemcitabine 1000 mg/m 2 and intravenous carboplatin', 'Trilaciclib plus chemotherapy', 'trilaciclib plus gemcitabine and carboplatin chemotherapy', 'gemcitabine and carboplatin']","['Safety', 'anaemia', 'Severe neutropenia', 'neutropenia', 'myelosuppression endpoints', 'unacceptable toxicity, withdrawal of consent, or discontinuation', 'mean duration of severe neutropenia', 'nausea', 'tolerated and overall survival', 'thrombocytopenia', 'Overall survival', 'duration of severe neutropenia during cycle 1 and the occurrence of severe neutropenia', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",142.0,0.0748289,"No significant differences were observed in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer; however, the regimen was generally well tolerated and overall survival results were encouraging.","[{'ForeName': 'Antoinette R', 'Initials': 'AR', 'LastName': 'Tan', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC, USA. Electronic address: antoinette.tan@atriumhealth.org.'}, {'ForeName': 'Gail S', 'Initials': 'GS', 'LastName': 'Wright', 'Affiliation': 'Florida Cancer Specialists and Research Institute, New Port Richey, FL, USA.'}, {'ForeName': 'Anu R', 'Initials': 'AR', 'LastName': 'Thummala', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Danso', 'Affiliation': 'Virginia Oncology Associates, Norfolk, VA, USA.'}, {'ForeName': 'Lazar', 'Initials': 'L', 'LastName': 'Popovic', 'Affiliation': 'Oncology Institute of Vojvodina, University of Novi Sad, Serbia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Pluard', 'Affiliation': ""Saint Luke's Cancer Institute, Kansas City, MO, USA.""}, {'ForeName': 'Hyo S', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Vojnović', 'Affiliation': 'Varaždin General Hospital, Varaždin, Croatia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Vasev', 'Affiliation': 'University Clinic of Radiotherapy and Oncology, Skopje, Macedonia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Rocky Mountain Cancer Centers, Lakewood, CO, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Texas Oncology-Tyler, US Oncology Research, Tyler, TX, USA.'}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Wilks', 'Affiliation': 'Texas Oncology-San Antonio, US Oncology Research, San Antonio, TX, USA.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Milenković', 'Affiliation': 'Clinical Center Niš, Niš, Serbia.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology Dallas, US Oncology Research, Dallas, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30616-3'] 1399,28009070,Effects of aripiprazole and haloperidol on neural activation during a simple motor task in healthy individuals: A functional MRI study.,"The dopaminergic system plays a key role in motor function and motor abnormalities have been shown to be a specific feature of psychosis. Due to their dopaminergic action, antipsychotic drugs may be expected to modulate motor function, but the precise effects of these drugs on motor function remain unclear. We carried out a within-subject, double-blind, randomized study of the effects of aripiprazole, haloperidol and placebo on motor function in 20 healthy men. For each condition, motor performance on an auditory-paced task was investigated. We entered maps of neural activation into a random effects general linear regression model to investigate motor function main effects. Whole-brain imaging revealed a significant treatment effect in a distributed network encompassing posterior orbitofrontal/anterior insula cortices, and the inferior temporal and postcentral gyri. Post-hoc comparison of treatments showed neural activation after aripiprazole did not differ significantly from placebo in either voxel-wise or region of interest analyses, with the results above driven primarily by haloperidol. We also observed a simple main effect of haloperidol compared with placebo, with increased task-related recruitment of posterior cingulate and precentral gyri. Furthermore, region of interest analyses revealed greater activation following haloperidol compared with placebo in the precentral and post-central gyri, and the putamen. These diverse modifications in cortical motor activation may relate to the different pharmacological profiles of haloperidol and aripiprazole, although the specific mechanisms underlying these differences remain unclear. Evaluating healthy individuals can allow investigation of the effects of different antipsychotics on cortical activation, independently of either disease-related pathology or previous treatment. Hum Brain Mapp 38:1833-1845, 2017. © 2017 Wiley Periodicals, Inc.",2017,"Whole-brain imaging revealed a significant treatment effect in a distributed network encompassing posterior orbitofrontal/anterior insula cortices, and the inferior temporal and postcentral gyri.","['Evaluating healthy individuals', '20 healthy men', 'healthy individuals']","['aripiprazole and haloperidol', 'placebo', 'haloperidol', 'aripiprazole, haloperidol and placebo', 'aripiprazole']",['neural activation'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],20.0,0.0624655,"Whole-brain imaging revealed a significant treatment effect in a distributed network encompassing posterior orbitofrontal/anterior insula cortices, and the inferior temporal and postcentral gyri.","[{'ForeName': 'Rhianna', 'Initials': 'R', 'LastName': 'Goozee', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Centre for Neuroimaging Sciences (CNS), King's College London, London, United Kingdom.""}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Handley', 'Affiliation': 'Bristol-Myers Squibb, New York, New York.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Reis Marques', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'McQueen', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hubbard', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Pariante', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Antje A T S', 'Initials': 'AA', 'LastName': 'Reinders', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Dazzan', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, King's College London, London, United Kingdom.""}]",Human brain mapping,['10.1002/hbm.23485'] 1400,27859982,Transcranial direct current stimulation effects on neural processing in post-stroke aphasia.,"Non-invasive transcranial direct current stimulation (tDCS) can enhance recovery after stroke. However, fundamental knowledge about how tDCS impacts neural processing in the lesioned human brain is currently lacking. In the present study, it was investigated how tDCS modulates brain function in patients with post-stroke language impairment (aphasia). In a cross-over, randomized trial, patients named pictures of common objects during functional magnetic resonance imaging (fMRI). Concurrently, excitatory (anodal-) or sham-tDCS (1 mA, 20 min, or 30 s, respectively) was administered to the left primary motor cortex, a montage with demonstrated potential to improve aphasic language. By choosing stimuli that could reliable be named by the patients, the authors aimed to derive a pure measure of stimulation effects that was independent of treatment or performance effects and to assess how tDCS interacts with the patients' residual language network. Univariate fMRI data analysis revealed reduced activity in domain-general regions mediating high-level cognitive control during anodal-tDCS. Independent component functional network analysis demonstrated selectively increased language network activity and an inter-correlated shift from higher to lower frequency bands, indicative of increased within-network communication. Compared with healthy controls, anodal-tDCS resulted in overall ""normalization"" of brain function in the patients. These results demonstrate for the first time how tDCS modulates neural processing in stroke patients. Such information is crucial to assure that behavioral treatments targeting specific neural circuits overlap with regions that are modulated by tDCS, thereby maximizing stimulation effects during therapy. Hum Brain Mapp 38:1518-1531, 2017. © 2016 Wiley Periodicals, Inc.",2017,"Independent component functional network analysis demonstrated selectively increased language network activity and an inter-correlated shift from higher to lower frequency bands, indicative of increased within-network communication.","['post-stroke aphasia', 'patients with post-stroke language impairment (aphasia', 'stroke patients']","['anodal-tDCS', 'Transcranial direct current stimulation', 'excitatory (anodal-) or sham-tDCS', 'functional magnetic resonance imaging (fMRI', 'invasive transcranial direct current stimulation (tDCS']","['language network activity', 'overall ""normalization"" of brain function', 'brain function']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023015', 'cui_str': 'Language Disorders'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.134858,"Independent component functional network analysis demonstrated selectively increased language network activity and an inter-correlated shift from higher to lower frequency bands, indicative of increased within-network communication.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Darkow', 'Affiliation': 'Department of Neurology, NeuroCure Clinical Research Center, and Center of Stroke Research Berlin, Berlin, Charité University Medicine, Berlin, 10117, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'The University of Queensland, Centre for Clinical Research, Brisbane Queensland, 4029, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Würtz', 'Affiliation': 'Department of Neurology, NeuroCure Clinical Research Center, and Center of Stroke Research Berlin, Berlin, Charité University Medicine, Berlin, 10117, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Flöel', 'Affiliation': 'Department of Neurology, NeuroCure Clinical Research Center, and Center of Stroke Research Berlin, Berlin, Charité University Medicine, Berlin, 10117, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'Department of Neurology, NeuroCure Clinical Research Center, and Center of Stroke Research Berlin, Berlin, Charité University Medicine, Berlin, 10117, Germany.'}]",Human brain mapping,['10.1002/hbm.23469'] 1401,31567604,Effect of respiratory muscle training session on ankle muscle activity in athletes with chronic low back pain performing overhead squats: a randomized controlled trial.,"AIM The current study was conducted to evaluate the effect of a respiratory muscle training session on ankle muscle activity in athletes with chronic low back pain performing overhead squats. METHODS The current double-blind, randomized, controlled trial was conducted on 24 patients randomly selected as the training group and 23 patients as the control group. The training group received the respiratory muscle training protocol. The electromyography activity of the tibialis anterior, peroneus longus, gastrocnemius medialis and gastrocnemius lateralis muscles of the dominant leg was recorded in the participants. RESULTS The findings showed that a session of respiratory muscle training reduced the activities of some ankle joint muscles when performing overhead squats, including tibialis anterior in the static and dynamic overhead squat tests and peroneus longus in the ascending phase. In the dynamic test, the angle to reach peak activity changed in tibialis anterior in the descending phase and also in tibialis anterior and peroneus longus in the ascending phase. CONCLUSION Effects of respiratory muscle training prevented excessive ankle joint muscle activity through stimulating local muscles while performing overhead squats, which had indicated an improved postural control and multisectional proprioception to maintain postural stability and stimulated the local muscles of the core area.",2020,"The findings showed that a session of respiratory muscle training reduced the activities of some ankle joint muscles when performing overhead squats, including tibialis anterior in the static and dynamic overhead squat tests and peroneus longus in the ascending phase.","['athletes with chronic low back pain performing overhead squats', '24 patients randomly selected as the training group and 23 patients as the control group']","['respiratory muscle training session', 'respiratory muscle training protocol', 'respiratory muscle training']","['excessive ankle joint muscle activity', 'electromyography activity of the tibialis anterior, peroneus longus, gastrocnemius medialis and gastrocnemius lateralis muscles of the dominant leg', 'ankle muscle activity', 'activities of some ankle joint muscles']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",,0.035588,"The findings showed that a session of respiratory muscle training reduced the activities of some ankle joint muscles when performing overhead squats, including tibialis anterior in the static and dynamic overhead squat tests and peroneus longus in the ascending phase.","[{'ForeName': 'Behnam Gholami', 'Initials': 'BG', 'LastName': 'Borujeni', 'Affiliation': 'Department of Corrective Exercises and Sport Injury, Faculty of Physical Education and Sport Sciences, Bu-Ali Sina University, Hamedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalfani', 'Affiliation': ''}]",International journal of evidence-based healthcare,['10.1097/XEB.0000000000000204'] 1402,31728883,Hypofractionated radiotherapy with temozolomide in diffuse intrinsic pontine gliomas: a randomized controlled trial.,"INTRODUCTION Diffuse intrinsic pontine glioma (DIPG) is the most common form of brainstem glioma. The present study was performed to assess if hypofractionated radiotherapy completed in < 3 weeks with temozolomide improves survival in DIPG. MATERIAL AND METHODS The present study is a phase II open label randomized trial. The study included newly diagnosed patients with DIPG. Patients in arm A received conventional fractionated RT of 60 Gy in 30 fractions over 6 weeks while patients in arm B received hypo-fractionated radiotherapy of 39 Gy in 13 fractions over 2.6 weeks along with concurrent Temozolomide (TMZ) 75 mg/m 2 from day 1 to day 17 followed by adjuvant TMZ for six cycles. The survival analysis was performed with modified intention to treat analysis. RESULTS A total of 35 patients were randomized. 33 patients were evaluable. 93% (n = 14) of patients in the conventional arm completed treatment while only 17% (n = 3) of the children could complete planned course of treatment in the experimental arm. The median overall survival (OS) was 11 months (95% CI - 7.5 to 14.5 months) in the conventional arm and 12 months (95% CI - 10.5 to 13.5 months) in the experimental arm (p = 0.208). 28% (n = 5) patients in the experimental arm developed grade 3 or 4 hematological toxicity. CONCLUSION The above study shows that hypofractionated radiotherapy with concurrent and adjuvant temozolomide does not improve OS and has higher hematological toxicity. Conventional radiotherapy remains the standard of care.",2020,The median overall survival (OS) was 11 months (95% CI - 7.5 to 14.5 months) in the conventional arm and 12 months (95% CI - 10.5 to 13.5 months) in the experimental arm (,"['33 patients were evaluable', 'diffuse intrinsic pontine gliomas', 'newly diagnosed patients with DIPG', '35 patients were randomized']","['hypofractionated radiotherapy', 'hypo-fractionated radiotherapy of 39\xa0Gy in 13 fractions over 2.6\xa0weeks along with concurrent Temozolomide (TMZ', 'hypofractionated radiotherapy with concurrent and adjuvant temozolomide', 'temozolomide', 'TMZ', 'Hypofractionated radiotherapy with temozolomide', 'Conventional radiotherapy', 'conventional fractionated RT']","['hematological toxicity', 'grade 3 or 4 hematological toxicity', 'median overall survival (OS', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0058409', 'cui_str': 'DiPG'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.214912,The median overall survival (OS) was 11 months (95% CI - 7.5 to 14.5 months) in the conventional arm and 12 months (95% CI - 10.5 to 13.5 months) in the experimental arm (,"[{'ForeName': 'Yousra', 'Initials': 'Y', 'LastName': 'Izzuddeen', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India. Drsubhash_oncologist@yahoo.in.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Haresh', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dayanand', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Giridhar', 'Affiliation': 'Department of Radiation Oncology, National Cancer Institute, All India Institute of Medical Sciences, Badsa, India.'}, {'ForeName': 'Gour Kishore', 'Initials': 'GK', 'LastName': 'Rath', 'Affiliation': 'Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of neuro-oncology,['10.1007/s11060-019-03340-7'] 1403,31020797,Intra-aortic balloon pump counterpulsation in extensive myocardial infarction with persistent ischemia: The SEMPER FI pilot study.,"OBJECTIVES This study aimed to prospectively investigate intra-aortic balloon pump counterpulsation (IABP) support in large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI). BACKGROUND Use of IABP is suggested to be effective by increasing diastolic aortic pressure, thereby improving coronary blood flow. This can only be expected with exhausted coronary autoregulation, typical in acute myocardial infarction complicated by persistent ischemia. In this situation, augmented diastolic pressure is expected to increase myocardial oxygenation. METHODS One hundred patients with large STEMI complicated by persistent ischemia after primary PCI were randomized to treatment with or without IABP therapy on top of standard care. IABP support was initiated following primary PCI, immediately after inclusion. Primary end point was all-cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months. RESULTS Mean age was 63 ± 10 years, 76% were male. Mean systolic and diastolic blood pressure were 120 ± 25 mmHg and 73 ± 17 mmHg. Mean heart rate was 75 ± 18 mmHg. Before PCI, mean summed ST-deviation was 21 ± 8 mm with only minimal ST-resolution after PCI. One patient in the IABP group reached the primary end point versus four patients in the control group (2% vs. 8%; p = 0.16). After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01). CONCLUSIONS In this pilot study, in patients with large STEMI and persistent ischemia after primary PCI, use of IABP showed a nonsignificant decrease in mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure at 6 months, and resulted in more rapid ST-resolution.",2020,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01). ","['extensive myocardial infarction with persistent ischemia', 'Mean age was 63\u2009±\u200910 years, 76% were male', 'One hundred patients with large STEMI complicated by persistent ischemia after primary PCI', 'large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI']","['IABP', 'Intra-aortic balloon pump counterpulsation', 'IABP therapy', 'aortic balloon pump counterpulsation (IABP']","['resolution of ST-deviation', 'diastolic aortic pressure', 'coronary blood flow', 'myocardial oxygenation', 'Mean systolic and diastolic blood pressure', 'cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months', 'diastolic pressure', 'Mean heart rate', 'mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump, device (physical object)'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",100.0,0.0286795,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01). ","[{'ForeName': 'Lokien X', 'Initials': 'LX', 'LastName': 'van Nunen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Wijnbergen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Guus R G', 'Initials': 'GRG', 'LastName': 'Brueren', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Pim A L', 'Initials': 'PAL', 'LastName': 'Tonino', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Wilbert A', 'Initials': 'WA', 'LastName': 'Aarnoudse', 'Affiliation': 'Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Nico H J', 'Initials': 'NHJ', 'LastName': 'Pijls', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28289'] 1404,28657141,Neural correlates of atomoxetine improving inhibitory control and visual processing in Drug-naïve adults with attention-deficit/hyperactivity disorder.,"Atomoxetine improves inhibitory control and visual processing in healthy volunteers and adults with attention-deficit/hyperactivity disorder (ADHD). However, little is known about the neural correlates of these two functions after chronic treatment with atomoxetine. This study aimed to use the counting Stroop task with functional magnetic resonance imaging (fMRI) and the Cambridge Neuropsychological Test Automated Battery (CANTAB) to investigate the changes related to inhibitory control and visual processing in adults with ADHD. This study is an 8-week, placebo-controlled, double-blind, randomized clinical trial of atomoxetine in 24 drug-naïve adults with ADHD. We investigated the changes of treatment with atomoxetine compared to placebo-treated counterparts using the counting Stroop fMRI and two CANTAB tests: rapid visual information processing (RVP) for inhibitory control and delayed matching to sample (DMS) for visual processing. Atomoxetine decreased activations in the right inferior frontal gyrus and anterior cingulate cortex, which were correlated with the improvement in inhibitory control assessed by the RVP. Also, atomoxetine increased activation in the left precuneus, which was correlated with the improvement in the mean latency of correct responses assessed by the DMS. Moreover, anterior cingulate activation in the pre-treatment was able to predict the improvements of clinical symptoms. Treatment with atomoxetine may improve inhibitory control to suppress interference and may enhance the visual processing to process numbers. In addition, the anterior cingulate cortex might play an important role as a biological marker for the treatment effectiveness of atomoxetine. Hum Brain Mapp 38:4850-4864, 2017. © 2017 Wiley Periodicals, Inc.",2017,"Atomoxetine decreased activations in the right inferior frontal gyrus and anterior cingulate cortex, which were correlated with the improvement in inhibitory control assessed by the RVP.","['healthy volunteers and adults with attention-deficit/hyperactivity disorder (ADHD', 'adults with ADHD', 'Drug-naïve adults with attention-deficit/hyperactivity disorder', '24 drug-naïve adults with ADHD']","['Atomoxetine', 'placebo', 'atomoxetine', 'placebo-treated counterparts using the counting Stroop fMRI and two CANTAB tests: rapid visual information processing (RVP) for inhibitory control and delayed matching to sample (DMS', 'counting Stroop task with functional magnetic resonance imaging (fMRI) and the Cambridge Neuropsychological Test Automated Battery (CANTAB']","['inhibitory control and visual processing', 'mean latency of correct responses', 'anterior cingulate activation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}]",,0.0743955,"Atomoxetine decreased activations in the right inferior frontal gyrus and anterior cingulate cortex, which were correlated with the improvement in inhibitory control assessed by the RVP.","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Tai-Li', 'Initials': 'TL', 'LastName': 'Chou', 'Affiliation': 'Department of Psychology, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Susan Shur-Fen', 'Initials': 'SS', 'LastName': 'Gau', 'Affiliation': 'Department of Psychiatry, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan.'}]",Human brain mapping,['10.1002/hbm.23683'] 1405,28600159,Building research in diet and cognition: The BRIDGE randomized controlled trial.,"Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia. Furthermore, weight loss through caloric restriction improves cognitive function. This paper describes the Building Research in Diet and CoGnition (BRIDGE) study, a randomized trial examining the effect of the MedDiet, with and without weight loss, on cognitive functioning in obese older adults. Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years) (n=180) will be randomized in a 2:2:1 allocation scheme to: Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention to promote weight loss and weight loss maintenance. Both MedDiet intervention groups will meet for one individual session and 27 group sessions over an 8-month period. Individuals in the control group will not receive instruction on changing lifestyle habits. Outcomes will be assessed at baseline, 8 and 14months. The primary outcome is cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers.",2017,Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia.,"['Obese (BMI≥30 and ≤50kg/m 2 ) older adults (≥55years', 'diet and cognition', 'obese older adults']","['Mediterranean Diet (MedDiet', 'Typical Diet Control; MedDiet alone, without weight loss; or MedDiet lifestyle intervention']","['cognitive function', 'cognitive functioning; secondary outcomes will include changes in body weight, diet, cardiovascular, metabolic, and inflammatory biomarkers']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",180.0,0.0484956,Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Department of Medicine, Division of Academic Internal Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States; Cancer Center, Population Behavior and Health Outcome Program, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lamar', 'Affiliation': ""Department of Medicine and the Institute of Minority Health Research, University of Illinois at Chicago, Chicago, IL 60612, United States; The Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL 60612, United States.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry, Division of Behavioral Medicine, Duke University, Durham, NC 27710, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Babyak', 'Affiliation': 'Department of Psychiatry, Division of Behavioral Medicine, Duke University, Durham, NC 27710, United States.'}, {'ForeName': 'Giamila', 'Initials': 'G', 'LastName': 'Fantuzzi', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Blumstein', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Cancer Center, Population Behavior and Health Outcome Program, University of Illinois at Chicago, Chicago, IL 60612, United States; Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Pediatrics, University of Illinois at Chicago, Chicago, IL 60612, United States. Electronic address: mlf@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2017.06.003'] 1406,28603901,Blunted insula activation reflects increased risk and reward seeking as an interaction of testosterone administration and the MAOA polymorphism.,"Testosterone, a male sex hormone, has been suggested to partly explain mixed findings in males and females when investigating behavioral tendencies associated with the MAOA polymorphism. Prior studies indicated that the MAOA polymorphism represents a vulnerability factor for financial risk-taking and harm avoidance and that testosterone increases human risk-taking. We therefore assumed an interactive influence of the MAOA polymorphism and testosterone application on decision making and corresponding neural correlates in a risk and reward context. Stratified for the MAOA polymorphism (S =short, L =long), 103 healthy males were assigned to a placebo or testosterone group (double blind, randomized) receiving a topical gel containing 50 mg testosterone. During a functional MRI scan, the participants performed a sequential decision making task. Our results indicate that testosterone and the MAOA polymorphism jointly influence sequential decision making. The MAOA-S variant was associated with less automatic harm avoidance as reflected in response times on safe decisions. Moreover, after testosterone administration, MAOA-S carriers were more risk-taking. Overall activity in the anterior cingulate cortex, anterior insula and inferior frontal gyrus increased with growing risk for losses. In the anterior insula, testosterone administration mitigated this effect solely in MAOA-S carriers. This might be a reflection of an improved coping during risk-reward conflicts subsequently modulating risky decision making. While the molecular basis is not well defined so far, our results support the assumption of testosterone as a modulatory factor for previously reported sex differences of behavioral associations with the MAOA-S variant. Hum Brain Mapp 38:4574-4593, 2017. © 2017 Wiley Periodicals, Inc.",2017,"Overall activity in the anterior cingulate cortex, anterior insula and inferior frontal gyrus increased with growing risk for losses.",['103 healthy males'],"['topical gel containing 50 mg testosterone', 'placebo or testosterone', 'Testosterone']",['Overall activity'],"[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",103.0,0.140483,"Overall activity in the anterior cingulate cortex, anterior insula and inferior frontal gyrus increased with growing risk for losses.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wagels', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Votinov', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Radke', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clemens', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'Institue of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Institue of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, Uniklinik RWTH Aachen, Aachen, Germany.'}]",Human brain mapping,['10.1002/hbm.23685'] 1407,32413673,The effects of testosterone on the physiological response to social and somatic stressors.,"Higher testosterone levels in males have previously been linked to decreased stress reactivity, but in other cases, testosterone has been reported to increase the stress response. We addressed these inconsistencies in a placebo-controlled single-dose testosterone administration study, in which 120 male participants were randomly assigned to undergo a cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition). Throughout the experiment, blood pressure and interbeat intervals were measured continuously, and saliva samples for hormonal analyses were taken repeatedly at predefined time points. When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies. However, testosterone administration altered this pattern. Compared to placebo, testosterone increased systolic blood pressure during the CPT, whereas the opposite effect was found during the SECPT. Cortisol reactivity was not affected by testosterone administration. The CAG repeat polymorphism of the androgen receptor gene was unrelated to the effects of testosterone on the stress response, but it was correlated with blood pressure across the whole sample. Our findings demonstrate that testosterone's effects on the stress response are dependent on the social context. Testosterone's ability to flexibly influence the response to stressors may be an important mechanism through which the hormone promotes adaptive behavior. Our results are also in line with research showing that testosterone decreases social anxiety and suggest it may help to modulate the effects of stress in socially challenging situations.",2020,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.",['120 male participants'],"['SECPT', 'placebo, testosterone', 'testosterone', 'placebo-controlled single-dose testosterone', 'Testosterone', 'cold-pressor test (CPT, a non-social somatic stressor), a socially evaluated cold-pressor test (SECPT, a social-somatic stressor), or a lukewarm water test (LWT, a non-stressful control condition', 'placebo']","['blood pressure', 'blood pressure and interbeat intervals', 'systolic blood pressure', 'social anxiety', 'Cortisol reactivity']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",120.0,0.036,"When comparing the groups treated with placebo, the SECPT elicited a larger increase in the systolic blood pressure than CPT, in agreement with previous studies.","[{'ForeName': 'Hana H', 'Initials': 'HH', 'LastName': 'Kutlikova', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: hana.kutlikova@univie.ac.at.'}, {'ForeName': 'Jaroslava Babková', 'Initials': 'JB', 'LastName': 'Durdiaková', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, Comenius University in Bratislava, Sasinkova 2, 813 72 Bratislava, Slovakia. Electronic address: durdiakova.jaroslava@fmed.uniba.sk.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Institute of Biomedical Science, FH Joanneum University of Applied Sciences, Eggenberger Allee 13, 8020 Graz, Austria. Electronic address: bernhard.wagner@fh-joanneum.at.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Vlček', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Dúbravská cesta 9, 845 05 Bratislava, Slovakia. Electronic address: miroslav.vlcek@savba.sk.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Eisenegger', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Neuropsychopharmacology and Biopsychology Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Riečanský', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria; Department of Behavioural Neuroscience, Institute of Normal and Pathological Physiology, Centre of Experimental Medicine, Slovak Academy of Sciences, Sienkiewiczova 1, 813 71 Bratislava, Slovakia. Electronic address: igor.riecansky@savba.sk.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104693'] 1408,32413812,Effects of a mindfulness based behavioral intervention for young adults with childhood maltreatment history on hippocampal morphometry: a pilot MRI study with voxel-based morphometry.,"Childhood maltreatment has long lasting impacts on neural development of the hippocampus, which is important for learning and memory. The present study aimed to assess the effects of a mindfulness based intervention on hippocampal morphometry and episodic memory in this population. We administered MRI, psychological questionnaires and an episodic memory task to 21 participants (5 males) before and after a mindfulness-based behavioral intervention, compared to 21 participants (7 males) on the waiting list. Changes in Gray Matter Volume (GMV) in bilateral hippocampi were analyzed with Voxel-Based Morphometry (VBM). One cluster was identified in the right hippocampus with a group by time interaction effect that consisted of 130 contiguous voxels but fell short of significance with full FDR correction (p = 0.077). GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group. Within the mindfulness group, changes in hippocampal GMV were negatively associated with changes in perceived stress and depression severity and positively associated with enhancement in performance accuracy on the episodic memory task. Findings from this pilot study suggest that a mindfulness-based intervention may lead to an increase in partial hippocampal GMV with associated symptom reduction and improvement in episodic memory.",2020,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"['21 participants (5 males) before and after a', 'young adults with childhood maltreatment history on hippocampal morphometry']","['mindfulness based intervention', 'mindfulness-based behavioral intervention', 'mindfulness based behavioral intervention']","['perceived stress and depression severity', 'GMV', 'hippocampal morphometry and episodic memory', 'episodic memory', 'hippocampal GMV', 'partial hippocampal GMV', 'Gray Matter Volume (GMV']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]",130.0,0.0170544,GMV in this cluster increased by 0.76% in the mindfulness group and decreased by 0.78% in the control group.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111087'] 1409,31578954,"Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial.","BACKGROUND Tenofovir alafenamide is associated with less renal and bone toxicity than tenofovir disoproxil fumarate and might improve the long-term safety of antiretroviral therapy. We aimed to investigate the effect on bone mineral density of switching from a regimen containing tenofovir disoproxil fumarate to one containing tenofovir alafenamide in participants aged 60 years and older. METHODS We did a prospective, open-label, multicentre, randomised trial in 36 European centres. Participants were virologically suppressed (HIV-1 RNA <50 copies per mL), aged 60 years or older, on a tenofovir disoproxil fumarate-containing regimen and were randomly assigned (2:1) via an interactive web-response system to open-label elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg), and tenofovir alafenamide (10 mg) daily or continued therapy containing tenofovir disoproxil fumarate (300 mg). Participants were stratified by spine and hip bone mineral density categories. Primary endpoints were change from baseline to week 48 in spine and hip bone mineral density with a null hypothesis of zero between-group difference tested at a significance level of 0·05. This study was registered with ClinicalTrials.gov, NCT02616783. FINDINGS Between Dec 22, 2015, and March 21, 2018, 167 participants were randomly assigned to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (n=111 [66%]) or tenofovir disoproxil fumarate (n=56 [34%]). One participant in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group did not receive treatment and was excluded from all analyses. At week 48, the mean percentage change in spine bone mineral density was 2·24% (SD 3·27) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and -0·10% (3·39) in the tenofovir disoproxil fumarate group (between-group difference 2·43% [95% CI 1·34-3·52]; p<0·0001), and mean percentage change in hip bone mineral density was 1·33% (2·20) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and -0·73% (3·21) in the tenofovir disoproxil fumarate group (difference 2·04% [1·17-2·90]; p<0·0001). The most common adverse events were nasopharyngitis (12 [11%]), back pain (nine [8%]), and diarrhoea (eight [7%]) in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and bronchitis (six [11%]), vitamin D deficiency (four [7%]), and arthralgia (four [7%]) in the tenofovir disoproxil fumarate group. 22 (20%) participants in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group and one (2%) participant in the tenofovir disoproxil fumarate group had an adverse event that was considered to be related to treatment. No treatment-related serious adverse events were observed. The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group). INTERPRETATION The significantly improved bone mineral density, overall safety, and efficacy data show the feasibility of switching from a regimen containing tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV aged 60 years or older. FUNDING Gilead Sciences.",2019,"The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group). ","['Between Dec 22, 2015, and March 21, 2018', 'virologically suppressed people living with HIV aged 60 years or older', '167 participants were randomly assigned to', 'virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing', '36 European centres', 'participants aged 60 years and older', 'Participants were virologically suppressed (HIV-1 RNA <50 copies per mL), aged 60 years or older, on a']","['tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen', 'tenofovir disoproxil fumarate-containing regimen and were randomly assigned (2:1) via an interactive web-response system to open-label elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg), and tenofovir alafenamide (10 mg) daily or continued therapy containing tenofovir disoproxil fumarate', 'tenofovir alafenamide', 'tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide', 'elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide', 'tenofovir disoproxil fumarate']","['spine and hip bone mineral density', 'vitamin D deficiency', 'Bone mineral density', 'diarrhoea', 'bone mineral density, overall safety, and efficacy data', 'bone mineral density', 'back pain', 'arthralgia', 'hip bone mineral density', 'serious adverse events', 'renal and bone toxicity', 'spine bone mineral density']","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C2606637', 'cui_str': 'elvitegravir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",167.0,0.228122,"The proportions of adverse events leading to premature treatment discontinuation were similar between groups (four [4%] in the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide group; and one (2%) in the tenofovir disoproxil fumarate group). ","[{'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Rizzardini', 'Affiliation': 'Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy; School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Department of Infectious and Tropical Diseases and CIC 1413, INSERM, University Hospital, Nantes, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'HIV Unit, University Hospital 12 de Octubre, Imas12, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Maria Gracia', 'Initials': 'MG', 'LastName': 'Mateo-Garcia', 'Affiliation': 'Infectious Diseases Unit, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Saint Louis Hospital, University Paris Diderot, Paris, France.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Ong', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Trust, Newcastle, UK.'}, {'ForeName': 'Yongwu', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Piontkowsky', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Moupali', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McNicholl', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haubrich', 'Affiliation': 'Gilead Sciences, Foster City, CA, USA. Electronic address: richard.haubrich@gilead.com.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30195-X'] 1410,31474354,"Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial.","BACKGROUND Platinum-based chemotherapy is the foundation of treatment for platinum-sensitive recurrent ovarian cancer, but has substantial toxicity. Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors both significantly improve efficacy versus standard therapy, primarily in terms of progression-free survival, and offer the potential for chemotherapy-free treatment. AVANOVA2 compared niraparib and bevacizumab versus niraparib alone as definitive treatment for platinum-sensitive recurrent ovarian cancer. METHODS This open-label, randomised, phase 2, superiority trial in 15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer. Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease. Previous treatment with bevacizumab or first-line maintenance PARP inhibitors was permitted. Eligible patients were randomly assigned 1:1 (by random permuted blocks with block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab 15 mg/kg once every 3 weeks until disease progression. The primary endpoint was progression-free survival, assessed by the investigators in the intention-to-treat population after events in at least 62 patients. Safety was analysed in all patients who received at least one dose of study drug. This ongoing trial is registered with ClinicalTrials.gov, number NCT02354131. FINDINGS Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to niraparib plus bevacizumab and 49 to single-agent niraparib. Median follow-up was 16·9 months (IQR 15·4-20·9). Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months [95% CI 8·5-16·7] vs 5·5 months [3·8-6·3], respectively; adjusted hazard ratio [HR] 0·35 [95% CI 0·21-0·57], p<0·0001). Grade 3 or worse adverse events occurred in 31 (65%) of 48 patients who received niraparib plus bevacizumab and 22 (45%) of 49 who received single-agent niraparib. The most common grade 3 or worse adverse events in both groups were anaemia (7 [15%] of 48 vs 9 [18%] of 49) and thrombocytopenia (5 [10%] vs 6 [12%]), and hypertension in the combination group (10 [21%] vs 0). Niraparib plus bevacizumab was associated with increased incidences of any-grade proteinuria (10 [21%] of 48 patients vs 0) and hypertension (27 [56%] of 48 vs 11 [22%] of 49) compared with niraparib alone. No treatment-related deaths occurred. INTERPRETATION The efficacy observed with this chemotherapy-free combination of approved agents in women with platinum-sensitive recurrent ovarian cancer warrants further evaluation. A randomised phase 3 trial investigating niraparib plus bevacizumab versus chemotherapy plus bevacizumab in platinum-sensitive recurrent ovarian cancer is planned. FUNDING Nordic Society of Gynaecological Oncology and Tesaro.",2019,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"['platinum-sensitive recurrent ovarian cancer', 'Eligible patients', 'Between May 23, 2016, and March 6, 2017, 97 patients were enrolled and randomly assigned: 48 to', 'Patients had to have an Eastern Cooperative Oncology Group performance status of 0-2, and had to have previously received platinum-containing therapy for primary disease but ≤1 prior non-platinum-containing regimen for recurrent disease', 'women with platinum-sensitive recurrent ovarian cancer', '15 university hospitals in Denmark, Sweden, Finland, Norway, and the USA enrolled women aged 18 years or older with measurable or evaluable high-grade serous or endometrioid platinum-sensitive recurrent ovarian cancer', 'platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24']","['niraparib alone', 'bevacizumab', 'Niraparib plus bevacizumab', 'niraparib and bevacizumab', 'block sizes of two and four, no masking), stratified by homologous recombination deficiency status and chemotherapy-free interval, to receive once-daily oral niraparib 300 mg alone or with intravenous bevacizumab', 'AVANOVA2', 'Bevacizumab and maintenance poly(ADP-ribose) polymerase (PARP) inhibitors', 'Platinum-based chemotherapy', 'niraparib plus bevacizumab', 'chemotherapy plus bevacizumab']","['Grade 3 or worse adverse events', 'adverse events', 'progression-free survival', 'incidences of any-grade proteinuria', 'thrombocytopenia', 'hypertension', 'anaemia', 'Safety']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}]","[{'cui': 'C2744440', 'cui_str': 'niraparib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1882413', 'cui_str': 'PARP Inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",97.0,0.32479,Niraparib plus bevacizumab significantly improved progression-free survival compared with niraparib alone (median progression-free survival 11·9 months,"[{'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: mansoor.raza.mirza@regionh.dk.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Åvall Lundqvist', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': ""O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'dePont Christensen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Research Unit of General Practice University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gitte-Bettina', 'Initials': 'GB', 'LastName': 'Nyvang', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Malander', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Anttila', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Werner', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lindahl', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sakari', 'Initials': 'S', 'LastName': 'Hietanen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Peen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dimoula', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Roed', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ør Knudsen', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Synnöve', 'Initials': 'S', 'LastName': 'Staff', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Krog Vistisen', 'Affiliation': 'Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Bjørge', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway; Center for Cancer Biomarkers CCBIO, Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Johanna U', 'Initials': 'JU', 'LastName': 'Mäenpää', 'Affiliation': 'Nordic Society of Gynaecological Oncology, Copenhagen, Denmark; Department of Obstetrics and Gynecology and Tays Cancer Centre, Faculty of Medicine and Health Technology, Tampere University and University Hospital, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30515-7'] 1411,30996038,Validity evidence for Quality Improvement Knowledge Application Tool Revised (QIKAT-R) scores: consequences of rater number and type using neurology cases.,"OBJECTIVES To develop neurology scenarios for use with the Quality Improvement Knowledge Application Tool Revised (QIKAT-R), gather and evaluate validity evidence, and project the impact of scenario number, rater number and rater type on score reliability. METHODS Six neurological case scenarios were developed. Residents were randomly assigned three scenarios before and after a quality improvement (QI) course in 2015 and 2016. For each scenario, residents crafted an aim statement, selected a measure and proposed a change to address a quality gap. Responses were scored by six faculty raters (two with and four without QI expertise) using the QIKAT-R. Validity evidence from content, response process, internal structure, relations to other variables and consequences was collected. A generalisability (G) study examined sources of score variability, and decision analyses estimated projected reliability for different numbers of raters and scenarios and raters with and without QI expertise. RESULTS Raters scored 163 responses from 28 residents. The mean QIKAT-R score was 5.69 (SD 1.06). G-coefficient and Phi-coefficient were 0.65 and 0.60, respectively. Interrater reliability was fair for raters without QI expertise (intraclass correlation = 0.53, 95% CI 0.30 to 0.72) and acceptable for raters with QI expertise (intraclass correlation = 0.66, 95% CI 0.02 to 0.88). Postcourse scores were significantly higher than precourse scores (6.05, SD 1.48 vs 5.22, SD 1.5; p < 0.001). Sufficient reliability for formative assessment (G-coefficient > 0.60) could be achieved by three raters scoring six scenarios or two raters scoring eight scenarios, regardless of rater QI expertise. CONCLUSIONS Validity evidence was sufficient to support the use of the QIKAT-R with multiple scenarios and raters to assess resident QI knowledge application for formative or low-stakes summative purposes. The results provide practical information for educators to guide implementation decisions.",2019,"Postcourse scores were significantly higher than precourse scores (6.05, SD 1.48 vs 5.22, SD 1.5; p < 0.001).",[],[],"['Interrater reliability', 'Postcourse scores', 'mean QIKAT-R score']",[],[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0579466,"Postcourse scores were significantly higher than precourse scores (6.05, SD 1.48 vs 5.22, SD 1.5; p < 0.001).","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kassardjian', 'Affiliation': 'Department of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, University of Illinois at Chicago College of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Braksick', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cutsforth-Gregory', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Leep Hunderfund', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA leep.andrea@mayo.edu.'}]",BMJ quality & safety,['10.1136/bmjqs-2018-008689'] 1412,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting. OBJECTIVE To determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk. DESIGN VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median). SETTING Nationwide study. PARTICIPANTS Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline. INTERVENTIONS Vitamin D3 (cholecalciferol; 2,000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2X2 factorial design. MAIN OUTCOME MEASURES Two or more falls, falls resulting in a doctor or hospital visit. RESULTS Baseline serum total 25-hydroxyvitamin D [25(OH)D] level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with ≥2 falls were similar between active and placebo groups (9.8% vs. 9.4%). Over 5 years, there were no differences in the proportion having ≥2 falls (OR=0.97; 95% CI, 0.90-1.05, p=0.50), falls resulting in a doctor visit (OR=1.03; 95% CI, 0.94-1.13, p=0.46) or resulting in a hospital visit (OR=1.04; 95% CI, 0.90-1.19, p=0.61) between groups. Results did not differ between those with baseline 25(OH)D <50 vs. >50 nmol/L or other cutpoints. CONCLUSION Daily supplemental vitamin D3 vs. placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the U.S. population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, MA, United States.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311'] 1413,32412991,An Exploration of Health Behaviors in a Mind-Body Resilience Intervention for Parents of Children with Developmental Disabilities.,"OBJECTIVE Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD) are at high risk for stress-related disorders. The demands of parenting may compete with time for self-care behaviors such as physical activity, healthy eating, and adequate sleep. The objective was to describe health behaviors among this understudied population and assess the changes after a resilience intervention. METHODS This was a secondary data analysis of a randomized controlled pilot virtual mind-body resilience intervention (Stress Management and Resiliency Training: A Relaxation Response Resiliency Program) trial for parents of children with LADs (n = 52) and ASD (n = 47). Parents completed self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue before and after the 8-week intervention. Descriptive statistics and pre-post intervention effect sizes (Cohen's d) were calculated. RESULTS Both parent groups reported suboptimal levels of health behaviors at baseline, but ASD parents reported lower health behaviors than LAD parents. LAD parents improved more on physical activity, with a higher percentage meeting recommendations at postintervention follow-up (d = 0.71) than ASD parents (d = 0.01). Eating behaviors showed small effect size improvements for both groups. Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81). CONCLUSION Parents of children with special needs who participated in a virtual resilience intervention demonstrated suboptimal health behaviors. There is a need for targeted interventions for health behaviors that can promote resilience in these high-stress populations.",2020,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81). ","['parents of children with LADs (n = 52) and ASD (n = 47', 'Parents of Children with Developmental Disabilities', 'Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD', 'Parents of children with special needs who participated in a']","['body resilience intervention (Stress Management and Resiliency Training', 'Mind-Body Resilience Intervention', 'virtual resilience intervention']","['self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue', 'sleep duration', 'physical activity', 'suboptimal health behaviors', 'health behaviors', 'suboptimal levels of health behaviors']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",52.0,0.0551803,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81). ","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Tucson, AZ.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Gabrielle N', 'Initials': 'GN', 'LastName': 'Schwartz', 'Affiliation': 'Health Policy Research Center, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kuhlthau', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000813'] 1414,31567579,How Does Perioperative Ketorolac Affect Opioid Consumption and Pain Management After Ankle Fracture Surgery?,"BACKGROUND The investigation of nonnarcotic drug regimens for postoperative pain management is important in addressing the opioid epidemic. NSAIDs can be a powerful adjunct in managing postoperative pain, but the possibility of delayed bone healing is a major concern for orthopaedic surgeons. Our recent retrospective study on ketorolac administration demonstrated that the NSAID is not associated with an increased risk of delayed union or nonunion after ankle fracture surgery. QUESTIONS/PURPOSES To determine whether postoperative ketorolac (1) reduces opioid consumption, (2) improves VAS pain control, and (3) affects fracture healing after open reduction and internal fixation of ankle fractures. METHODS Between August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture were randomized before surgery via simple randomization to treatment with or without ketorolac. No patients changed treatment regimen groups or opted out of randomization. All other aspects of perioperative care were treated identically. A once-daily survey was distributed via email on postoperative Days 1 to 7. Unblinded participants were asked to report their daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency using a five-point Likert scale, and side effects with the VAS. For VAS pain, > 20 mm/100 mm on the VAS scale was required to be considered ""improved."" In all, 83% (106 of 128) patients completed all seven postoperative surveys with 14 in the control group and eight in the ketorolac group lost to follow-up. Fifty-six patients were administered ketorolac with opioid medication (treatment group) and 50 were administered opioids alone (control group). Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years. The treating surgeon assessed clinical healing based on the patient's ability to ambulate comfortably at 12 weeks postoperatively. Radiographic healing was assessed by two fellowship-trained orthopaedic foot and ankle surgeons blinded to the patient's name and time since surgery. The surgeons evaluated randomized standard ankle series (anteroposterior, mortise, and lateral) radiographs for resolution of each fracture line to determine fracture union, with delayed union being defined as fracture lines present on radiographs taken at 12-week postoperative visits. Intention-to-treat analysis was performed. RESULTS Patients in the treatment group consumed a mean of 14 opioid pills, which was less than the mean of 19.3 opioids pills consumed by patients in the control group (p = 0.037). Patients with ketorolac had lower median VAS scores for pain (p < 0.035) postoperatively on postoperative Days 1 and 2 than did control patients. By contrast, patient-reported pain scores and scores for sleep did not convincingly show a benefit to the use of ketorolac. For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). CONCLUSIONS In this randomized study, adding ketorolac to the postoperative drug regimen decreased the use of opioid medication after open reduction and internal fixation of ankle fractures in the early postoperative period, and there were mixed, small effects on pain reduction. This NSAID is a valuable tool in helping patients manage postoperative pain with less use of narcotic analgesia. However, our study was underpowered to determine the true safety of this drug in terms of fracture healing and side effects and these questions warrant higher-powered randomized study investigation. LEVEL OF EVIDENCE Level I, therapeutic study.",2020,"For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). ","['Between August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture', 'Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years', 'Fifty-six patients were administered']","['postoperative ketorolac', 'ketorolac with opioid medication', 'opioids alone (control group', 'surgery via simple randomization to treatment with or without ketorolac', 'ketorolac']","['VAS scale', 'risk of delayed union or nonunion', 'median VAS scores for pain', 'radiographic healing', 'VAS pain control, and (3) affects fracture healing', 'fracture healing and side effects', 'mean of 14 opioid pills', 'Pain Management', 'clinical healing', 'pain scores and scores for sleep', 'Radiographic healing', 'pain reduction', 'daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",128.0,0.0907682,"For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961). ","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'McDonald', 'Affiliation': 'E. L. McDonald, J. N. Daniel, R. G. Rogero, R. J. Shakked, K. Nicholson, D. I. Pedowitz, S. M. Raikin, B. S. Winters, Rothman Orthopaedic Institute, Philadelphia, PA, USA E. L. McDonald, R. G. Rogero, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA V. Bilolikar, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Daniel', 'Affiliation': ''}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Rogero', 'Affiliation': ''}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Shakked', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nicholson', 'Affiliation': ''}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Pedowitz', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Raikin', 'Affiliation': ''}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bilolikar', 'Affiliation': ''}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Winters', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000978'] 1415,32413595,Double trouble: Do symptom severity and duration interact to predicting treatment outcomes in adolescent depression?,"Studies suggest that depression severity and duration interact to predict outcomes in depression treatment. To our knowledge, no study has explored this question in a sample with a placebo control, two therapies, and their combination nor with adolescents. We used data from the Treatment of Adolescent Depression Study (N = 439), in which adolescent were randomized to placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB). We explore the interaction between depression severity, chronicity, and treatments (vs. placebo) in predicting outcomes. There was interaction between severity and chronicity when comparing COMB and CBT with PBO, but not MEDs. In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression. In chronic depression, the effects of CBT did not vary by severity, but the relative effects of COMB grew, being smallest in milder, more dysthymic-like depression, and largest in chronic-severe depression. These findings support calls to classify depression by severity and chronicity as well efforts to risk stratify patients to different intensity of care according to these variables.",2020,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.",['Adolescent Depression Study (N\xa0=\xa0439'],"['CBT', 'placebo (PBO), cognitive-behavioral therapy (CBT), antidepressants medications (MEDs), or their combination (COMB', 'placebo']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",[],,0.0183832,"In non-chronic depression, the effects of CBT were inversely related to severity to the point that CBT appeared iatrogenic with more severe depression.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA. Electronic address: lolorenz@indiana.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rodriguez-Quintana', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, IN, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103637'] 1416,31859677,Perceptions and Experiences of Women Participating in a Digital Technology-Based Physical Activity Intervention (the mPED Trial): Qualitative Study.,"BACKGROUND Despite the benefits of regular physical activity, women in every age group have lower activity levels than men, and few women meet the recommended levels of physical activity. Digital technologies have been useful in increasing physical activity during the course of an interventional study. However, sustaining that activity once the clinical trial was complete was a major challenge. OBJECTIVE This study aimed to describe the experiences and perspectives of physically inactive women who completed the mobile phone-based physical activity education (mPED), a randomized controlled trial, at 12 months. METHODS Of 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone. The participants were asked about their physical activity levels; their digital technology use; what they learned from, liked, and would change about the trial; their motivations to keep active post-trial; and their advice for other women. Interviews were transcribed verbatim and thematically analyzed using the brief survey qualitative description. Descriptive statistics were used to describe the survey data with the significance level set at P<.05. RESULTS In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001). The experiences and perceptions of physical activity of physically inactive women over time were embedded in a complex interplay of internal and external factors. A total of 6 interactive themes emerged as critical in supporting continued engagement in physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation. Technology allowed for self-tracking, which supported internal accountability. However, tracking by another person (personal touch) was needed for external accountability. Resources and environment underpinned the relationship among the themes of tracking, technology versus personal touch, accountability, motivation, and habit formation. CONCLUSIONS Future research is needed to identify the best ways to harness this dynamic process in promoting and sustaining physical activity among inactive women. Digital technology is evolving at an exponential rate and provides new opportunities to transform research into new approaches to promote physical activity. TRIAL REGISTRATION ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/1471-2485-11-933.",2019,"In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001).","['physically inactive women who completed the', 'Of 210 women who were enrolled in the mPED trial, 203 completed a 12-month open-ended exit interview and survey through phone']","['mobile phone-based physical activity education (mPED', 'Digital Technology-Based Physical Activity Intervention']","['pedometer or physical activity tracker', 'physical activity postintervention: tracking, technology versus personal touch, accountability, resources and environment, motivation, and habit formation', 'physical activity', 'brisk walking']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0078889', 'cui_str': 'Accountability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}]",203.0,0.0666894,"In the 12-month survey, a greater proportion of the participants in the intervention group, compared with the control group, reported that they regularly wore a pedometer or physical activity tracker (49.3%, 66/143 vs 26.1%, 18/69; P=.002) and engaged in brisk walking (54.5%, 73/134 vs 30.4%, 21/69; P=.001).","[{'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Lindgren', 'Affiliation': 'School of Nursing, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hooper', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'Physiological Nursing, Univesity of California, San Francisco, San Francisco, CA, United States.'}]",JMIR public health and surveillance,['10.2196/13570'] 1417,27565830,"Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.","BACKGROUND Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. METHODS This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged >60 (ASCS). RESULTS Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. CONCLUSION To date, recruitment and implementation of Harvest for Health appears feasible. DISCUSSION Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL.",2016,Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL.,"['82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS', 'two different populations of cancer survivors', '46 older cancer survivors aged >60 (ASCS']",['Vegetable gardening interventions'],"['Response rates', 'diet, physical activity, and quality of life']","[{'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}]",82.0,0.0806712,Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL.,"[{'ForeName': 'Mallory G', 'Initials': 'MG', 'LastName': 'Cases', 'Affiliation': 'Department of Health Behavior, School of Public Health, University of Alabama at Birmingham, 1675 University Boulevard, Webb Building 346, Birmingham, AL 35294, United States. Electronic address: mgcases@uab.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, 1675 University Boulevard, Webb Building 346, Birmingham, AL 35294, United States.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'De Los Santos', 'Affiliation': 'Department of Radiation Oncology, School of Medicine, University of Alabama at Birmingham, The Kirklin Clinic at Acton Road, 2145 Bonner Way, Birmingham, AL 35243, United States.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Locher', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, 1530 3rd Avenue South, CH19-Room 218F, Birmingham, AL 35294, United States.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Cantor', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, 1665 University Boulevard, Ryals Public Health Building, Room 327, Birmingham, AL 35294, United States.'}, {'ForeName': 'Kerry P', 'Initials': 'KP', 'LastName': 'Smith', 'Affiliation': 'Alabama Cooperative Extension System, Alabama A&M University and Auburn University, 101 Funchess Hall, Auburn University, AL 36849, United States.'}, {'ForeName': 'Tony A', 'Initials': 'TA', 'LastName': 'Glover', 'Affiliation': 'Alabama Cooperative Extension System, Alabama A&M University and Auburn University, 101 Funchess Hall, Auburn University, AL 36849, United States.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Center for the Study of Aging, Duke University, Room 3502 Blue Zone, Duke University Medical Center Box 3003, Durham, NC 27710, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Department of Biology, College of Arts & Sciences, University of Alabama at Birmingham, 1675 University Boulevard, Webb Building 346, Birmingham, AL 35294, United States.'}, {'ForeName': 'Casey D', 'Initials': 'CD', 'LastName': 'Morrow', 'Affiliation': 'Department of Cell, Developmental, and Integrative Biology, School of Medicine, University of Alabama at Birmingham, 1720 2nd Avenue South, THT 926, Birmingham, AL 35294, United States.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Moellering', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, 1675 University Boulevard, Webb Building 346, Birmingham, AL 35294, United States; UAB Diabetes Research Center, Bioanalytical Redox Biology Core, University of Alabama at Birmingham, 1670 University Boulevard, VH G004, Birmingham, AL 35294, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, School of Health Professions, University of Alabama at Birmingham, 1675 University Boulevard, Webb Building 346, Birmingham, AL 35294, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2016.08.014'] 1418,31473167,Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial.,"BACKGROUND Human monoclonal antibodies that potently and broadly neutralise HIV-1 are under development to prevent and treat HIV-1 infection. In this phase 1 clinical trial we aimed to determine the safety, tolerability, and pharmacokinetic profile of the broadly neutralising monoclonal antibody VRC07-523LS, an engineered variant of VRC01 that targets the CD4 binding site of the HIV-1 envelope protein. METHODS This phase 1, open-label, dose-escalation clinical trial was done at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Individuals were recruited from the greater Washington, DC, area by IRB-approved written and electronic media. We enrolled healthy, HIV-1-negative adults aged 18-50 years. Inclusion criteria were good general health, measured through clinical laboratory tests, medical history, and physical examination. Participants self-selected into one of seven open groups during enrolment without randomisation. Four groups received a single intravenous dose of 1, 5, 20, or 40 mg/kg of VRC07-523LS, and one group received a single 5 mg/kg subcutaneous dose. Two groups received three doses of either 20 mg/kg intravenous VRC07-523LS, or 5 mg/kg subcutaneous VRC07-523LS at 12-week intervals. The primary outcome was the safety and tolerability of VRC07-523LS, assessed by dose, route, and number of administrations. This study is registered with ClinicalTrials.gov, NCT03015181. FINDINGS Between Feb 21, 2017, and September 13, 2017, we enrolled 26 participants, including 11 (42%) men and 15 (58%) women. Two (8%) participants withdrew from the study early: one participant in group 1 enrolled in the study but never received VRC07-523LS, and one participant in group 6 chose to withdraw after a single administration. One (4%) participant in group 7 received only one of the three scheduled administrations. 17 participants received intravenous administrations and 8 participants received subcutaneous administrations. VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects. All reported local and systemic reactogenicity was mild to moderate in severity. The most commonly reported symptoms following intravenous administration were malaise or myalgia in three (18%) participants and headache or chills in two (12%) participants. The most commonly reported symptoms following subcutaneous administration were pain and tenderness in four participants (50%) and malaise or headache in three (38%) participants. INTERPRETATION Safe and well tolerated, VRC07-523LS is a strong and practical candidate for inclusion in HIV-1 prevention and therapeutic strategies. The results from this trial also indicate that an HIV-1 broadly neutralising monoclonal antibody engineered for improved pharmacokinetic and neutralisation properties can be safe for clinical use. FUNDING National Institutes of Health.",2019,"VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects.","['Between Feb 21, 2017, and September 13, 2017', 'enrolled healthy, HIV-1-negative adults aged 18-50 years', 'Participants self-selected into one of seven open groups during enrolment without randomisation', 'enrolled 26 participants, including 11 (42%) men and 15 (58%) women', 'healthy adults', '17 participants']","['20 mg/kg intravenous VRC07-523LS, or 5 mg/kg subcutaneous VRC07-523LS', 'neutralising human monoclonal antibody VRC07-523LS', 'VRC07-523LS']","['local and systemic reactogenicity', 'safety and tolerability of VRC07-523LS, assessed by dose, route, and number of administrations', 'malaise or headache', 'malaise or myalgia', 'safe and well tolerated', 'headache or chills', 'pain and tenderness', 'safety, tolerability, and pharmacokinetic profile']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0234242', 'cui_str': 'Pain and tenderness (finding)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",26.0,0.269949,"VRC07-523LS was safe and well tolerated, we observed no serious adverse events or dose-limiting toxic effects.","[{'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Gaudinski', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Houser', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Doria-Rose', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ro Shauna S', 'Initials': 'RSS', 'LastName': 'Rothwell', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Costner', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'LaSonji A', 'Initials': 'LA', 'LastName': 'Holman', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Hendel', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Kaltovich', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Conan-Cibotti', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Gomez Lorenzo', 'Affiliation': 'Vaccine Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sitar', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Laurencot', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bob C', 'Initials': 'BC', 'LastName': 'Lin', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adrian B', 'Initials': 'AB', 'LastName': 'McDermott', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sung-Youl', 'Initials': 'SY', 'LastName': 'Ko', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amarendra', 'Initials': 'A', 'LastName': 'Pegu', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Young D', 'Initials': 'YD', 'LastName': 'Kwon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Kwong', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Aryan M', 'Initials': 'AM', 'LastName': 'Namboodiri', 'Affiliation': 'Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Janardan P', 'Initials': 'JP', 'LastName': 'Pandey', 'Affiliation': 'Department of Microbiology and Immunology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Arnold', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'School of Medicine, University of California San Diego, San Diego, CA, USA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: ledgerwood@mail.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30181-X'] 1419,31573919,A Biofeedback App to Instruct Abdominal Breathing (Breathing-Mentor): Pilot Experiment.,"BACKGROUND Deep and slow abdominal breathing is an important skill for the management of stress and pain. However, despite multiple proofs on the effectiveness of biofeedback, most breathing apps remain limited to pacing specific breathing patterns, without sensor feedback on the actual breathing behavior. OBJECTIVE To fill this gap, an app named Breathing-Mentor was developed. This app combines effective visualization of the instruction with biofeedback on deep abdominal breathing, based on the mobile phone's accelerometers. The aim of this pilot study was to investigate users' feedback and breathing behavior during initial contact with the app. METHODS To reveal the possible effects of biofeedback, two versions of the mobile app were developed. Both contained the same visual instruction, but only the full version included additional biofeedback. In total, 40 untrained participants were randomly assigned to one of the two versions of the app. They had to follow the app's instructions as closely as possible for 5 min. RESULTS The group with additional biofeedback showed an increased signal-to-noise ratio for instructed breathing frequency (0.1 Hz) compared with those using visual instruction without biofeedback (F 1,37 =4.18; P<.048). During this initial contact with the full version, self-reported relaxation effectivity was, however, lower than the group using visual instruction without biofeedback (t 37 =-2.36; P=.02), probably owing to increased cognitive workload to follow the instruction. CONCLUSIONS This study supports the feasibility and usefulness of incorporating biofeedback in the Breathing-Mentor app to train abdominal breathing. Immediate effects on relaxation levels should, however, not be expected for untrained users.",2019,"The group with additional biofeedback showed an increased signal-to-noise ratio for instructed breathing frequency (0.1 Hz) compared with those using visual instruction without biofeedback (F 1,37 =4.18; P<.048).",['40 untrained participants'],[],"['signal-to-noise ratio for instructed breathing frequency', 'relaxation effectivity', 'cognitive workload', 'relaxation levels']",[],[],"[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0414041,"The group with additional biofeedback showed an increased signal-to-noise ratio for instructed breathing frequency (0.1 Hz) compared with those using visual instruction without biofeedback (F 1,37 =4.18; P<.048).","[{'ForeName': 'Corinna Anna', 'Initials': 'CA', 'LastName': 'Faust-Christmann', 'Affiliation': 'wearHEALTH, Department of Computer Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Taetz', 'Affiliation': 'wearHEALTH, Department of Computer Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Zolynski', 'Affiliation': 'wearHEALTH, Department of Computer Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Zimmermann', 'Affiliation': 'wearHEALTH, Department of Computer Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bleser', 'Affiliation': 'wearHEALTH, Department of Computer Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}]",JMIR mHealth and uHealth,['10.2196/13703'] 1420,31573935,"Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial.","BACKGROUND There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone-based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. TRIAL REGISTRATION ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427.",2019,"At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys.","['We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012', '7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms', '6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial']","['mobile text messaging versus email', 'Email', 'Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging']","['7-day self-reported point prevalence abstinence (PPA', 'response rates', '7-day PPA']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002045'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.357888,"At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys.","[{'ForeName': 'Inger Torhild', 'Initials': 'IT', 'LastName': 'Gram', 'Affiliation': 'Norwegian Centre for E-health Research, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Dillys', 'Initials': 'D', 'LastName': 'Larbi', 'Affiliation': 'Norwegian Centre for E-health Research, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Silje Camilla', 'Initials': 'SC', 'LastName': 'Wangberg', 'Affiliation': 'Department of Health and Caring Sciences, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}]",JMIR mHealth and uHealth,['10.2196/12137'] 1421,28018270,Psychological Effects of a 1-Month Meditation Retreat on Experienced Meditators: The Role of Non-attachment.,"Background: There are few studies devoted to assessing the impact of meditation-intensive retreats on the well-being, positive psychology, and personality of experienced meditators. We aimed to assess whether a 1-month Vipassana retreat: (a) would increase mindfulness and well-being; (b) would increase prosocial personality traits; and (c) whether psychological changes would be mediated and/or moderated by non-attachment. Method: A controlled, non-randomized, pre-post-intervention trial was used. The intervention group was a convenience sample ( n = 19) of experienced meditators who participated in a 1-month Vipassana meditation retreat. The control group ( n = 19) comprised matched experienced meditators who did not take part in the retreat. During the retreat, the mean duration of daily practice was 8-9 h, the diet was vegetarian and silence was compulsory. The Experiences Questionnaire (EQ), Non-attachment Scale (NAS), Positive and Negative Affect Schedule (PANAS), Satisfaction With Life Scale (SWLS), Temperament Character Inventory Revised (TCI-R-67), Five Facets Mindfulness Questionnaire (FFMQ), Self-Other Four Immeasurables (SOFI) and the MINDSENS Composite Index were administered. ANCOVAs and linear regression models were used to assess pre-post changes and mediation/moderation effects. Results: Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life. Conclusions: A 1-month Vipassana meditation retreat seems to yield improvements in mindfulness, well-being, and personality, even in experienced meditators. Non-attachment might facilitate psychological improvements of meditation, making it possible to overcome possible ceiling effects ascribed to non-intensive practices.",2016,"Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life. ",['Experienced Meditators'],"['convenience sample ( n = 19) of experienced meditators who participated in a 1-month Vipassana meditation retreat', '1-Month Meditation Retreat']","['prosocial personality traits', 'non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness', 'Experiences Questionnaire (EQ), Non-attachment Scale (NAS), Positive and Negative Affect Schedule (PANAS), Satisfaction With Life Scale (SWLS), Temperament Character Inventory Revised (TCI-R-67), Five Facets Mindfulness Questionnaire (FFMQ), Self-Other Four Immeasurables (SOFI) and the MINDSENS Composite Index', 'mean duration of daily practice']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150277'}]","[{'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule (assessment scale)'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",19.0,0.0254023,"Compared to controls, retreatants showed increases in non-attachment, observing, MINDSENS, positive-affect, balance-affect, and cooperativeness; and decreases in describing, negative-others, reward-dependence and self-directedness. Non-attachment had a mediating role in decentring, acting aware, non-reactivity, negative-affect, balance-affect and self-directedness; and a moderating role in describing and positive others, with both mediating and moderating effects on satisfaction with life. ","[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Montero-Marin', 'Affiliation': 'Faculty of Health and Sport Sciences, Primary Care Prevention and Health Promotion Research Network, Zaragoza, Centro de Investigación Biomédica en Red de Salud Mental, Zaragoza, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Puebla-Guedea', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental, Primary Care Prevention and Health Promotion Research Network, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental, Primary Care Prevention and Health Promotion Research Network, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain.'}, {'ForeName': 'Ausias', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Soler', 'Affiliation': 'Servei de Psiquiatria, Hospital de la Santa Creu i Sant Pau (Barcelona), Departamento de Psicologia Clínica i de la Salut, Universitat Autònoma de Barcelona, Barcelona, Spain Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Madrid, Spain.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Demarzo', 'Affiliation': 'Mente Aberta – Brazilian Center for Mindfulness and Health Promotion, Department of Preventive Medicine, Universidade Federal de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Vazquez', 'Affiliation': 'Professor of Psychopathology, Universidad Complutense de Madrid, Red PROMOSAM, Valencia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Bornaetxea', 'Affiliation': 'Psychologist and Vipassana Master, President of Baraka Institute, San Sebastián, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Miguel Servet Hospital and University of Zaragoza, Primary Care Prevention and Health Promotion Research Network, Instituto de Investigación Sanitaria Aragón (IIS Aragon), Centro de Investigación Biomédica en Red de Salud Mental, Zaragoza, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2016.01935'] 1422,32413383,Cost-effectiveness of adding fluoride varnish to a preventive protocol for early childhood caries in rural children with no access to fluoridated drinking water.,"OBJECTIVES Evidence of the cost-effectiveness of fluoride varnish in the prevention of caries is not yet fully conclusive. The aim of this study was to assess the incremental cost-effectiveness ratio (ICER) of the community-wide application of fluoride varnish in the prevention of early childhood caries (ECC) in non-fluoridated areas. MATERIALS AND METHODS A cost-effectiveness analysis was carried out based on a clinical decision tree from the payer's perspective. The effectiveness and cost of the varnish were determined from a two-year follow-up triple-blind randomized control trial in 275 two- to three-year-old children. Costs and benefits were discounted at 3% per year. Only direct costs were evaluated, expressed in Chilean pesos (CLP) valued in July, 2019 (exchange rate USD = CLP686.06). A univariate deterministic sensitivity analysis was carried out. RESULTS Incidence of ECC was 45 % for the varnish group and 55.6 % for the placebo group with a two-year follow-up. The weighted cost to intervene and treat the consequences of ECC was CLP 67,757 (USD98.76) for the fluoride varnish and CLP 67,739 (USD98.74) for the control group. The ICER was CLP 173 (USD0.25) for each extra healthy child in favor of fluoride varnish. The sensitivity analysis showed that the increase in caries was the variable which most influenced the ICER. CONCLUSIONS The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo. CLINICAL SIGNIFICANCE Findings support the application of fluoride varnish as a cost-effective community strategy to prevent ECC in non-fluoridated areas.",2020,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo. ","['rural children with no access to fluoridated drinking water', '275 two- to three-year-old children', 'early childhood caries (ECC) in non-fluoridated areas']","['fluoride varnish', 'placebo']","['Cost-effectiveness', 'Costs and benefits', 'caries', 'incremental cost-effectiveness ratio (ICER', 'Incidence of ECC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010187', 'cui_str': 'Benefits and Costs'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]",,0.119731,"The protocol that included fluoride varnish is more effective and less costly in the prevention of ECC in non-fluoridated areas, compared with a placebo. ","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zaror', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile. Electronic address: carlos.zaror@ufrontera.cl.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz-Millán', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: patricia.munoz@ufrontera.cl.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Espinoza-Espinoza', 'Affiliation': 'Center for Research in Epidemiology, Economics and Oral Public Health (CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile; Department of Public Health, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile. Electronic address: gerardo.espinoza@ufrontera.cl.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vergara-González', 'Affiliation': 'Aysén Health Service, Coyhaique, Chile. Electronic address: carovergarag@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Martínez-Zapata', 'Affiliation': 'Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: MMartinezz@santpau.cat.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103374'] 1423,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial. MATERIAL AND METHODS A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed. RESULTS Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. CONCLUSION Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006'] 1424,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment. METHOD Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms. RESULTS Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376'] 1425,29076400,"The cortisol awakening response after sleep deprivation: Is the cortisol awakening response a ""response"" to awakening or a circadian process?","This study tested whether the cortisol awakening response is dependent on the transition from sleep to awakening, or alternatively, a circadian-driven process that is independent of awakening. A total of 40 participants were randomly assigned to either a total sleep deprivation or a sleep condition. Salivary cortisol was also assessed. Participants in the sleep condition demonstrated a traditional cortisol awakening response, whereas participants in the total sleep deprivation condition showed no increases in morning cortisol. These results are consistent with the notion that if circadian-driven processes are related to the cortisol awakening response, they may only be activated when awakening occurs or is anticipated.",2020,"Participants in the sleep condition demonstrated a traditional cortisol awakening response, whereas participants in the total sleep deprivation condition showed no increases in morning cortisol.",['A total of 40 participants'],['total sleep deprivation or a sleep condition'],"['cortisol awakening response', 'morning cortisol', 'traditional cortisol awakening response', 'Salivary cortisol', 'total sleep deprivation condition']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",40.0,0.02634,"Participants in the sleep condition demonstrated a traditional cortisol awakening response, whereas participants in the total sleep deprivation condition showed no increases in morning cortisol.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Vargas', 'Affiliation': 'University of Pennsylvania, USA.'}, {'ForeName': 'Nestor', 'Initials': 'N', 'LastName': 'Lopez-Duran', 'Affiliation': 'University of Michigan, USA.'}]",Journal of health psychology,['10.1177/1359105317738323'] 1426,32412387,The cost effectiveness of pembrolizumab versus chemotherapy or atezolizumab as second-line therapy for advanced urothelial carcinoma in the United States.,"Aims: Pembrolizumab demonstrated significantly prolonged overall survival (OS) vs. chemotherapy in the Phase III KEYNOTE-045 trial, and is approved in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who progressed after platinum-based chemotherapy. Using longer follow-up and individual patient-data from KEYNOTE-045, this study evaluates the cost-effectiveness of pembrolizumab vs. chemotherapy or atezolizumab from a US payer perspective. Materials and methods: A partitioned-survival model was developed over a 20-year time horizon. Progression-free survival (PFS) and OS for pembrolizumab and chemotherapy were extrapolated using a piecewise modelling approach, where patient-level data from KEYNOTE-045 were used for the initial period followed by parametric distributions. OS of atezolizumab was estimated by indirect treatment comparisons based on KEYNOTE-045 and IMvigor211. Different scenarios were explored in the absence of indirect comparisons on PFS and time-on-treatment (ToT) between pembrolizumab and atezolizumab. Drug acquisition/administration, disease management, adverse events, and terminal care costs were considered. Results: Compared with chemotherapy, pembrolizumab resulted in a mean gain of 1.33 life-years and 1.14 quality-adjusted life-years (QALYs) and an incremental cost of $106,299, yielding an incremental cost-effectiveness ratio of $93,481/QALY gained. Pembrolizumab dominated atezolizumab in extending patients' life by 0.89 years and 0.76 QALYs, while reducing costs by $26,458. Key drivers of cost-effectiveness included survival extrapolation, OS hazard ratio of pembrolizumab vs. atezolizumab, and time horizon. Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold. Limitations and conclusions: Uncertainties remain with extrapolated PFS and OS for pembrolizumab, OS indirect comparison, and ToT for atezolizumab. Despite these limitations, the model used robust methods to estimate key clinical endpoints with patient-level data from longer follow-up of KEYNOTE-045. Pembrolizumab dominates atezolizumab and is very likely cost-effective vs. chemotherapy in 2 L mUC at a $100,000 willingness-to-pay threshold.",2020,"Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold.","['patients with locally advanced or metastatic urothelial carcinoma (mUC) who progressed after platinum-based chemotherapy', 'advanced urothelial carcinoma in the United States']","['atezolizumab', 'Pembrolizumab dominated atezolizumab', 'pembrolizumab versus chemotherapy or atezolizumab', 'Pembrolizumab', 'pembrolizumab vs. chemotherapy or atezolizumab', 'chemotherapy, pembrolizumab']","['survival extrapolation, OS hazard ratio of pembrolizumab vs. atezolizumab and time horizon', 'Progression-free survival (PFS) and OS', 'incremental cost-effectiveness ratio', 'Drug acquisition/administration, disease management, adverse events and terminal care costs', 'cost effectiveness', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0711215,"Pembrolizumab had a 66% and 100% probability of being cost-effective vs. chemotherapy and atezolizumab, respectively, at a $100,000 willingness-to-pay threshold.","[{'ForeName': 'Rachael Louise', 'Initials': 'RL', 'LastName': 'Slater', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Yizhen', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Blanca Homet', 'Initials': 'BH', 'LastName': 'Moreno', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'James Luke', 'Initials': 'JL', 'LastName': 'Godwin', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Frenkl', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Guru P', 'Initials': 'GP', 'LastName': 'Sonpavde', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1770261'] 1427,31375523,Preoperative Circulating Succinate Levels as a Biomarker for Diabetes Remission After Bariatric Surgery.,"OBJECTIVE To determine the potential use of baseline circulating succinate to predict type 2 diabetes remission after bariatric surgery. RESEARCH DESIGN AND METHODS Forty-five obese patients with diabetes were randomly assigned to Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or laparoscopic greater curvature plication. Anthropometric parameters were evaluated, and a complete biochemical analysis including circulating serum succinate concentrations was performed at baseline and 1 year after surgery. The results were externally validated in a second cohort including 88 obese patients with diabetes assigned to RYGB or SG based on clinical criteria. RESULTS Succinate baseline concentrations were an independent predictor of diabetes remission after bariatric surgery. Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018). Moreover, succinate concentrations were significantly decreased 1 year after surgery (58.9 [46.4-82.4] µmol/L vs. 46.0 [35.8-65.3] µmol/L, P = 0.005). In multivariate analysis, the best logistic regression model showed that baseline succinate (odds ratio [OR] 11.3, P = 0.031) and the type of surgery (OR 26.4, P = 0.010) were independently associated with remission. The C-statistic for this model was 0.899 (95% CI 0.809-0.989) in the derivation cohort, which significantly improved the prediction of remission compared with current available scores, and 0.729 (95% CI 0.612-0.846) in the validation cohort. Interestingly, patients had a different response to the type of surgery according to baseline succinate, with significant differences in remission rates. CONCLUSIONS Circulating succinate is reduced after bariatric surgery. Baseline succinate levels have predictive value for diabetes remission independently of previously described presurgical factors and improve upon the current available scores to predict remission.",2019,Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018).,"['88 obese patients with diabetes assigned to RYGB or SG based on clinical criteria', 'Forty-five obese patients with diabetes', 'Diabetes Remission After Bariatric Surgery']","['Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or laparoscopic greater curvature plication']","['diabetes remission', 'prediction of remission', 'remission rates', 'levels of baseline succinate', 'succinate concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",45.0,0.129784,Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ceperuelo-Mallafré', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Llauradó', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Keiran', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Benaiges', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Brenno', 'Initials': 'B', 'LastName': 'Astiarraga', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Martínez', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellitero', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Jose Miguel', 'Initials': 'JM', 'LastName': 'González-Clemente', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'Metabolic Research Laboratory, Clínica Universidad de Navarra, CIBEROBN, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Fernández-Real', 'Affiliation': ""Department of Diabetes, Endocrinology and Nutrition, Institut d'Investigació Biomèdica de Girona, CIBEROBN (CB06/03/010) and ISCIII, Girona, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lecube', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitari Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Megía', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain sonia.fernandezveledo@gmail.com jvo@comt.es.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain sonia.fernandezveledo@gmail.com jvo@comt.es.""}]",Diabetes care,['10.2337/dc19-0114'] 1428,31590139,Measuring the effects on quality of life and alcohol consumption of a program to reduce binge drinking in Spanish adolescents.,"AIM To present a comparison between the effects on health due to a reduction in binge drinking (BD) and health-related quality of life (HRQoL), as a result of ALERTA ALCOHOL, an intervention aimed at reducing BD in Spanish adolescents. METHODS A two-arm cluster randomized controlled trial was conducted with an intervention and a control group, randomized at the school level, following individuals over four months. The study population consisted of Andalusian adolescents aged 15 to 19 years who were enrolled in urban public high schools (n = 1247). Participants were assigned randomly to receive the intervention. The main outcomes studied were the number of occasions of BD in the last 30 days, which was directly obtained from the answers given by the adolescents, and HRQoL measured with the EQ-5D-5 L questionnaire. The model of estimation was the generalized estimating equations (GEE) approach. RESULTS The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention. However, it was shown that those who would predictably reduce the number of occasions of BD controlled by several sociodemographic variables perceived a higher HRQoL, as did those who had a greater adherence to the program. CONCLUSIONS Higher adherence to a web-based computer-tailored intervention to prevent BD in adolescents has a positive effect on decreasing the number of occasions of BD in adolescents as well as on increasing participants' HRQoL, although this second effect is very small, which could be due to the short follow-up time. This fact is quite important and should be assessed extensively to corroborate the results and translate into health policy.",2019,"The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention.","['Spanish adolescents', 'Andalusian adolescents aged 15 to 19 years who were enrolled in urban public high schools (n\u202f=\u202f1247']",[],"['HRQoL', 'quality of life and alcohol consumption', 'binge drinking (BD) and health-related quality of life (HRQoL', 'number of occasions of BD']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034380'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",1247.0,0.0539145,"The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention.","[{'ForeName': 'Ana Magdalena', 'Initials': 'AM', 'LastName': 'Vargas-Martínez', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain; Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: avargas5@us.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: mtrapero@uic.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lima-Serrano', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain. Electronic address: mlima@us.es.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': 'Health Economics Research Group (HERG), Brunel University, Uxbridge, London, UK. Electronic address: nana.anokye@brunel.ac.uk.'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Pokhrel', 'Affiliation': 'Health Economics Research Group (HERG), Brunel University, Uxbridge, London, UK. Electronic address: subhash.pokhrel@brunel.ac.uk.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Mora', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: tmora@uic.es.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107597'] 1429,28855077,"Effect of interleukin-1β inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial.","BACKGROUND Inflammation in the tumour microenvironment mediated by interleukin 1β is hypothesised to have a major role in cancer invasiveness, progression, and metastases. We did an additional analysis in the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS), a randomised trial of the role of interleukin-1β inhibition in atherosclerosis, with the aim of establishing whether inhibition of a major product of the Nod-like receptor protein 3 (NLRP3) inflammasome with canakinumab might alter cancer incidence. METHODS We did a randomised, double-blind, placebo-controlled trial of canakinumab in 10 061 patients with atherosclerosis who had had a myocardial infarction, were free of previously diagnosed cancer, and had concentrations of high-sensitivity C-reactive protein (hsCRP) of 2 mg/L or greater. To assess dose-response effects, patients were randomly assigned by computer-generated codes to three canakinumab doses (50 mg, 150 mg, and 300 mg, subcutaneously every 3 months) or placebo. Participants were followed up for incident cancer diagnoses, which were adjudicated by an oncology endpoint committee masked to drug or dose allocation. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, NCT01327846. The trial is closed (the last patient visit was in June, 2017). FINDINGS Baseline concentrations of hsCRP (median 6·0 mg/L vs 4·2 mg/L; p<0·0001) and interleukin 6 (3·2 vs 2·6 ng/L; p<0·0001) were significantly higher among participants subsequently diagnosed with lung cancer than among those not diagnosed with cancer. During median follow-up of 3·7 years, compared with placebo, canakinumab was associated with dose-dependent reductions in concentrations of hsCRP of 26-41% and of interleukin 6 of 25-43% (p<0·0001 for all comparisons). Total cancer mortality (n=196) was significantly lower in the pooled canakinumab group than in the placebo group (p=0·0007 for trend across groups), but was significantly lower than placebo only in the 300 mg group individually (hazard ratio [HR] 0·49 [95% CI 0·31-0·75]; p=0·0009). Incident lung cancer (n=129) was significantly less frequent in the 150 mg (HR 0·61 [95% CI 0·39-0·97]; p=0·034) and 300 mg groups (HR 0·33 [95% CI 0·18-0·59]; p<0·0001; p<0·0001 for trend across groups). Lung cancer mortality was significantly less common in the canakinumab 300 mg group than in the placebo group (HR 0·23 [95% CI 0·10-0·54]; p=0·0002) and in the pooled canakinumab population than in the placebo group (p=0·0002 for trend across groups). Fatal infections or sepsis were significantly more common in the canakinumab groups than in the placebo group. All-cause mortality did not differ significantly between the canakinumab and placebo groups (HR 0·94 [95% CI 0·83-1·06]; p=0·31). INTERPRETATION Our hypothesis-generating data suggest the possibility that anti-inflammatory therapy with canakinumab targeting the interleukin-1β innate immunity pathway could significantly reduce incident lung cancer and lung cancer mortality. Replication of these data in formal settings of cancer screening and treatment is required. FUNDING Novartis Pharmaceuticals.",2017,"Total cancer mortality (n=196) was significantly lower in the pooled canakinumab group than in the placebo group (p=0·0007 for trend across groups), but was significantly lower than placebo only in the 300 mg group individually (hazard ratio [HR]","['participants subsequently diagnosed with lung cancer than among those not diagnosed with cancer', '10\u2008061 patients with atherosclerosis who had had a myocardial infarction, were free of previously diagnosed cancer, and had concentrations of high-sensitivity C-reactive protein (hsCRP) of 2 mg/L or greater', 'patients with atherosclerosis', '0·33', 'Participants were followed up for incident cancer diagnoses, which were adjudicated by an oncology endpoint committee masked to drug or dose allocation', '0·49']","['canakinumab', 'interleukin-1β inhibition with canakinumab', 'placebo']","['incident lung cancer and lung cancer mortality', 'incident lung cancer', 'All-cause mortality', 'Total cancer mortality', 'Lung cancer mortality', 'Incident lung cancer', 'Fatal infections or sepsis', 'concentrations of hsCRP']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",10061.0,0.766208,"Total cancer mortality (n=196) was significantly lower in the pooled canakinumab group than in the placebo group (p=0·0007 for trend across groups), but was significantly lower than placebo only in the 300 mg group individually (hazard ratio [HR]","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: pridker@partners.org.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA; Novartis Pharmaceuticals, Basel, Switzerland.'}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(17)32247-X'] 1430,28580708,How the brain codes intimacy: The neurobiological substrates of romantic touch.,"Humans belong to a minority of mammalian species that exhibit monogamous pair-bonds, thereby enabling biparental care of offspring. The high reward value of interpersonal closeness and touch in couples is a key proximate mechanism facilitating the maintenance of enduring romantic bonds. However, surprisingly, the neurobiological underpinnings mediating the unique experience of a romantic partner's touch remain unknown. In this randomized placebo (PLC)-controlled, between-group, pharmacofunctional magnetic resonance imaging (fMRI) study involving 192 healthy volunteers (96 heterosexual couples), we intranasally administered 24 IU of the hypothalamic peptide oxytocin (OXT) to either the man or the woman. Subsequently, we scanned the subjects while they assumed that they were being touched by their romantic partners or by an unfamiliar person of the opposite sex, although in reality an identical pattern of touch was always given by the same experimenter. Our results show that intranasal OXT compared to PLC selectively enhanced the subjective pleasantness of the partner's touch. Importantly, intranasal OXT selectively increased responses to partner touch in the nucleus accumbens (NAcc) and anterior cingulate cortex. Under OXT, NAcc activations to partner touch positively correlated with the subjects' evaluation of their relationship quality. Collectively, our results suggest that OXT may contribute to the maintenance of monogamous relationships in humans by concomitantly increasing the reward value of partner touch and diminishing the hedonic quality of stranger touch. Hum Brain Mapp 38:4525-4534, 2017. © 2017 Wiley Periodicals, Inc.",2017,Our results show that intranasal OXT compared to PLC selectively enhanced the subjective pleasantness of the partner's touch.,['192 healthy volunteers (96 heterosexual couples'],"['placebo (PLC)-controlled, between-group, pharmacofunctional magnetic resonance imaging (fMRI', 'intranasal OXT', 'OXT', 'hypothalamic peptide oxytocin (OXT']",['subjective pleasantness'],"[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",192.0,0.0217914,Our results show that intranasal OXT compared to PLC selectively enhanced the subjective pleasantness of the partner's touch.,"[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wassermann', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wollseifer', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Department of Clinical Chemistry and Clinical Pharmacology, University of Bonn, Bonn, 53127, Germany.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism, and National Institute on Drug Abuse, Bethesda, Maryland, 20892-1108.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, Giessen, 35394, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, 53105, Germany.'}]",Human brain mapping,['10.1002/hbm.23679'] 1431,32414580,"Osmotherapy for malignant cerebral edema in a phase 2 prospective, double blind, randomized, placebo-controlled study of IV glibenclamide.","BACKGROUND/OBJECTIVE Malignant edema can be a life-threatening complication of large hemispheric infarction (LHI), and is often treated with osmotherapy. In this exploratory analysis of data from the GAMES-RP study, we hypothesized that patients receiving osmotherapy had symptomatic cerebral edema, and that treatment with intravenous (IV) glibenclamide would modify osmotherapy use as compared with placebo. METHODS GAMES-RP was a phase 2 multi-center prospective, double blind, randomized, placebo-controlled study in LHI. Patients were randomized to IV glibenclamide (e.g. IV glyburide) or placebo. Cerebral edema therapies included osmotherapy and/or decompressive craniectomy at the discretion of the treating team. Total bolus osmotherapy dosing was quantified by ""osmolar load"". Radiographic edema was defined by dichotomizing midline shift at 24 h. Clinical changes were defined as any increase in NIHSS1a. RESULTS Osmotherapy was administered to 40 of the 77 patients at a median of 39 [27-55] h after stroke onset. The median baseline DWI lesion volume was significantly larger in the osmotherapy treated group (167 [146-211] mL v. 139 [112-170] mL; P=0.046). Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group. There were no differences in the proportion of patients receiving osmotherapy or the median total osmolar load between treatment arms. Most patients (76%) had a decrease in consciousness (NIHSS item 1A ≥1) on the day they began receiving osmotherapy. CONCLUSIONS In the GAMES-RP trial, osmolar therapies were most often administered in response to clinical symptoms of decreased consciousness. However, the optimal timing of administration and impact on outcome after LHI have yet to be defined.",2020,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,[],"['intravenous (IV) glibenclamide', 'Osmotherapy', 'osmotherapy and/or decompressive craniectomy', 'glibenclamide (e.g. IV glyburide) or placebo', 'glibenclamide', 'placebo']","['NIHSS1a', 'median baseline DWI lesion volume', 'symptomatic cerebral edema', 'consciousness (NIHSS item 1A ≥1', 'Radiographic edema', 'median total osmolar load', 'Adjudicated malignant edema']",[],"[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C4759300', 'cui_str': 'Osmotherapy'}, {'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439351', 'cui_str': 'osmol/L'}, {'cui': 'C0017105', 'cui_str': 'Gas gangrene'}]",,0.420017,Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group.,"[{'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': 'Departments of Neurology and Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CR-127, Portland, OR 97239, USA. Electronic address: hinson@ohsu.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Molyneaux', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: molyneauxbj@upmc.edu.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Kummer', 'Affiliation': 'Department of Neuroradiology, Universitätsklinikum Carl Gustav Carus, Dresden, Germany. Electronic address: Ruediger.vonKummer@uniklinikum-dresden.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: ademchuk@ucalgary.ca.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Division of Neuroradiology, Department of Radiology, Massachusetts General Hospital, Boston, MA, USA. Electronic address: JMROMERO@mgh.harvard.edu.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Taylor Kimberly', 'Affiliation': 'Department of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: WTKIMBERLY@mgh.harvard.edu.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Yale New Haven Hospital, New Haven, CT, USA. Electronic address: kevin.sheth@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104916'] 1432,27381253,Oxytocin enhances cognitive control of food craving in women.,"In developed countries, obesity has become an epidemic resulting in enormous health care costs for society and serious medical complications for individuals. The homeostatic regulation of food intake is critically dependent on top-down control of reward-driven food craving. There is accumulating evidence from animal studies that the neuropeptide oxytocin (OXT) is involved in regulating hunger states and eating behavior, but whether OXT also contributes to cognitive control of food craving in humans is still unclear. We conducted a counter-balanced, double-blind, within-subject, pharmacological magnetic resonance imaging experiment involving 31 healthy women who received 24 IU of intranasal OXT or placebo and were scanned twice while they were exposed to pictures of palatable food. The participants were instructed either to imagine the immediate consumption or to cognitively control the urge to eat the food. Our results show a trend that OXT specifically reduced food craving in the cognitive control condition. On the neural level, these findings were paralleled by an increase of activity in the middle and superior frontal gyrus, precuneus, and cingulate cortex under OXT. Interestingly, the behavioral OXT effect correlated with the OXT-induced changes in the prefrontal cortex and precuneus. Collectively, the present study provides first evidence that OXT plays a key role in the cognitive regulation of food craving in women by strengthening activity in a broad neurocircuitry implicated in top-down control and self-referential processing. Hum Brain Mapp 37:4276-4285, 2016. © 2016 Wiley Periodicals, Inc.",2016,"In developed countries, obesity has become an epidemic resulting in enormous health care costs for society and serious medical complications for individuals.","['31 healthy women who received 24 IU of', 'food craving in women', '2016']","['neuropeptide oxytocin (OXT', 'intranasal OXT or placebo', 'imagine the immediate consumption or to cognitively control the urge to eat the food', 'Oxytocin', 'OXT']","['behavioral OXT effect', 'food craving']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}]",31.0,0.0843099,"In developed countries, obesity has become an epidemic resulting in enormous health care costs for society and serious medical complications for individuals.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Striepens', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Schröter', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Department of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105, Bonn, Germany.'}]",Human brain mapping,['10.1002/hbm.23308'] 1433,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown. METHODS We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days. RESULTS We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. CONCLUSIONS After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. ","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported. ","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638'] 1434,31849035,Efficacy and safety of oral hyoscine used for outpatient cervical ripening among primiparous women with term pregnancy.,"OBJECTIVE To assess the efficacy and safety of outpatient administration of oral hyoscine for cervical ripening. METHODS In a randomized controlled trial at a university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 38 0 -40 0 gestational weeks and Bishop score of 5 or less were randomized to either routine expectant management (control group) or 10 mg of oral hyoscine twice daily for 1 week, followed by once daily for 1 week (hyoscine group). RESULTS Mean ± SD Bishop score in the hyoscine and control groups was, respectively, 1.19 ± 1.38 and 1.08 ± 1.70 at baseline, and 4.56 ± 2.87 and 2.76 ± 2.14 on admission for delivery (P=0.001). Duration of the first stage was 4.10 ± 5.49 hours in the hyoscine and 5.29 ± 6.48 hours in the control group (P=0.03). Duration of the second and third stages was, respectively, 0.52 ± 0.53 and 0.14 ± 0.25 hours in the hyoscine, and 0.59 ± 1.08 and 0.12 ± 0.15 hours in the control group. No adverse effects were reported. CONCLUSION Administration of oral hyoscine in an outpatient setting was found to ripen the cervix with no clinically significant adverse drug reaction. IRANIAN REGISTRY OF CLINICAL TRIALS (IRCT20180819040830N1).",2019,"No adverse effects were reported. ","['primiparous women with term pregnancy', 'university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 38 0 -40 0 gestational weeks and Bishop score of 5 or less']","['oral hyoscine', 'routine expectant management (control group) or 10\xa0mg of oral hyoscine', 'hyoscine']","['Efficacy and safety', 'adverse effects', 'Mean\xa0±', 'efficacy and safety', 'SD Bishop score']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2585455', 'cui_str': 'Expectant management (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]",,0.106776,"No adverse effects were reported. ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Naeiji', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Naghshvarian', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Mirzamoradi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sotudeh', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Moridi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13089'] 1435,32416495,Changing the future: An initial test of Future Specificity Training (FeST).,"A range of psychiatric disorders are characterised by impairments in episodic future thinking (EFT), and particularly simulating specific, spatiotemporally-located future events. No study has examined whether training can lead to sustained improvement in specific EFT. In this study, participants (N = 60; M age = 31, SD = 13.2) were randomized to a two-session, group-based future thinking program (Future Specificity Training; FeST) or wait-list. At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (d = 1.32), use of mental imagery (d = 1.32), anticipated (d = 1.78) and anticipatory pleasure (d = 1.07), perceived control (d = 1.20), and likelihood of occurrence (d = 1.09). Some effects were also observed on positive, generalised future self-states. In the context of inherent limitations of subjective reporting in trials, this study provides evidence that EFT specificity can be enhanced, and the effects of FeST indicate a possible avenue to disrupt psychopathological processes.",2020,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","['participants (N\xa0=\xa060; M age\xa0=\xa031, SD\xa0=\xa013.2']","['group-based future thinking program (Future Specificity Training; FeST) or wait-list', 'Future Specificity Training (FeST']","['anticipatory pleasure', 'detail ', 'ability to mentally simulate specific EFT']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",,0.0143698,"At follow-up the training group, relative to wait-list, showed large, statistically-significant improvements in the ability to mentally simulate specific EFT (d = .82), increases in detail (","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'J J E', 'Initials': 'JJE', 'LastName': 'Yeow', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fountas', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Herrick', 'Affiliation': 'School of Psychology, Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125, Melbourne, Australia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""D'Argembeau"", 'Affiliation': 'Psychology and Neuroscience of Cognition Research Unit, Department of Psychology, University of Liège, Belgium and Fonds de La Recherche Scientifique (F.R.S.-FNRS), Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103638'] 1436,29133012,Tinnitus-related fear: Mediating the effects of a cognitive behavioural specialised tinnitus treatment.,"OBJECTIVE Cognitive behavioural treatments (CBT) for the reduction of tinnitus complaints have been shown to be effective; however the specific mechanisms of change are yet to be unveiled. Reductions in tinnitus-related fear have been indicated to be an important factor in alleviating tinnitus suffering. The role of tinnitus-related fear has been proposed as a mediator explaining the cognitive behavioural treatment effects on tinnitus severity, tinnitus-related impairment and general quality of life of tinnitus patients. METHODS A two-group, single-centre RCT was carried out with adult tinnitus patients (n = 492), with 3 follow-up assessments up to 12 months after randomization. Patients were randomly assigned to Usual Care (UC) or Specialised cognitive behavioral stepped Care (SC). A repeated-measures design, with group as a between subjects factor, and time as the within-subject factor, was used in an intention-to-treat analysis. Mixed regressions for assessing mediation effects were performed with general health, tinnitus distress, tinnitus related impairment as the dependent variables and tinnitus related fear as the mediator variable. RESULTS Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. CONCLUSIONS The effectiveness of specialized cognitive behavioural treatment approaches for tinnitus might be partly explained by significant reductions in tinnitus-related fear. These results are relevant in that currently, though CBT approaches in tinnitus management have been proven to lead to decreased suffering of tinnitus patients, the psychological mechanisms causing these benefits are still to be discovered.",2018,"RESULTS Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. ",[],"['Usual Care (UC) or Specialised cognitive behavioral stepped Care (SC', 'cognitive behavioural specialised tinnitus treatment', 'Cognitive behavioural treatments (CBT']",['quality of life ratings'],[],"[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[{'cui': 'C0034380'}],,0.0405711,"RESULTS Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. ","[{'ForeName': 'Rilana F F', 'Initials': 'RFF', 'LastName': 'Cima', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands; Adelante, Centre of Research and Expertise in Rehabilitation & Audiology, Zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands. Electronic address: r.cima@maastrichtuniversity.nl.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': 'Department of Methodology and Statistics, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands. Electronic address: Gerard.vbreukelen@maastrichtuniversity.nl.'}, {'ForeName': 'Johan W S', 'Initials': 'JWS', 'LastName': 'Vlaeyen', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands; Research Group Health Psychology, University of Leuven, Tiensestraat 102, 3000, Leuven, Belgium. Electronic address: johannes.vlaeyen@kuleuven.be.'}]",Hearing research,['10.1016/j.heares.2017.10.003'] 1437,31563517,"Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial.","BACKGROUND IL-10 has anti-inflammatory and CD8+ T-cell stimulating activities. Pegilodecakin (pegylated IL-10) is a first-in-class, long-acting IL-10 receptor agonist that induces oligoclonal T-cell expansion and has single-agent activity in advanced solid tumours. We assessed the safety and activity of pegilodecakin with anti-PD-1 monoclonal antibody inhibitors in patients with advanced solid tumours. METHODS We did a multicentre, multicohort, open-label, phase 1b trial (IVY) at 12 cancer research centres in the USA. Patients were assigned sequentially into cohorts. Here, we report on all enrolled patients from two cohorts treated with pegilodecakin combined with anti-PD-1 inhibitors. Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients with uncontrolled infectious diseases were excluded. Pegilodecakin was provided in single-use 3 mL vials and was self-administered subcutaneously by injection at home at 10 μg/kg or 20 μg/kg once per day in combination with pembrolizumab (2 mg/kg every 3 weeks or 200 mg every 3 weeks) or nivolumab (3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks at the approved dosing), both of which were given intravenously at the study site. Patients received pembrolizumab or nivolumab with pegilodecakin until disease progression, toxicity necessitating treatment discontinuation, patient withdrawal of consent, or study end. The primary endpoints were safety and tolerability, assessed in all patients enrolled in the study who received any amount of study medication including at least one dose of pegilodecakin, and pharmacokinetics (previously published). Secondary endpoints included objective response by immune-related response criteria in all patients who were treated and had evaluable measurements. The study is active but no longer recruiting, and is registered with ClinicalTrials.gov, NCT02009449. FINDINGS Between Feb 13, 2015, and Sept 12, 2017, 111 patients were enrolled in the two cohorts. 53 received pegilodecakin plus pembrolizumab, and 58 received pegilodecakin plus nivolumab. 34 (31%) of 111 patients had non-small-cell lung cancer, 37 (33%) had melanoma, and 38 (34%) had renal cell carcinoma; one (<1%) patient had triple-negative breast cancer and one (<1%) had bladder cancer. Data cutoff was July 1, 2018. Median follow-up was 26·9 months (IQR 22·3-31·5) for patients with non-small-cell lung cancer, 33·0 months (29·2-35·1) for those with melanoma, and 22·7 months (20·9-27·0) for those with renal cell carcinoma. At least one treatment-related adverse event occurred in 103 (93%) of 111 patients. Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group). There were no fatal adverse events determined to be related to the study treatments. Of the patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma). INTERPRETATION In this patient population, pegilodecakin with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumour activity. Pegilodecakin with pembrolizumab or nivolumab could provide a new therapeutic opportunity for previously treated patients with renal cell carcinoma and non-small-cell carcinoma. FUNDING ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company.",2019,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","['Patients with uncontrolled infectious diseases', '111 patients were enrolled in the two cohorts', 'patients with advanced solid tumours (IVY', 'patients evaluable for response, objective responses were 12 (43%) of 28 (non-small-cell lung cancer), three (10%) of 31 (melanoma), and 14 (40%) of 35 (renal cell carcinoma', 'previously treated patients with renal cell carcinoma and non-small-cell carcinoma', 'Eligible patients were aged at least 18 years with histologically or cytologically confirmed advanced malignant solid tumours refractory to previous therapies, and an Eastern Cooperative Oncology Group performance status of 0 or 1', '12 cancer research centres in the USA', 'patients with advanced solid tumours']","['pegilodecakin plus nivolumab', 'pembrolizumab', 'pegilodecakin combined with anti-PD-1 inhibitors', 'pembrolizumab or nivolumab with pegilodecakin', 'Pegilodecakin combined with pembrolizumab or nivolumab', 'pegilodecakin with anti-PD-1 monoclonal antibody inhibitors', 'nivolumab', 'pegilodecakin plus pembrolizumab', 'Pegilodecakin (pegylated IL-10', 'Pegilodecakin', 'Pegilodecakin with pembrolizumab or nivolumab']","['Grade 3 or 4 events', 'thrombocytopenia', 'anaemia', 'fatal adverse events', 'bladder cancer', 'non-small-cell lung cancer', 'objective response by immune-related response criteria', 'renal cell carcinoma', 'adverse event', 'safety and activity', 'hypertriglyceridaemia', 'fatigue', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0446290', 'cui_str': 'Ivy (organism)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1266002', 'cui_str': 'Non-small cell carcinoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",111.0,0.307663,"Grade 3 or 4 events occurred in 73 (66%) of 111 patients (35 [66%] of 53 in the pembrolizumab group and 38 [66%] of 58 in the nivolumab group), the most common of which were anaemia (12 [23%] in the pembrolizumab group and 16 [28%] in the nivolumab group), thrombocytopenia (14 [26%] in the pembrolizumab group and 12 [21%] in the nivolumab group), fatigue (11 [21%] in the pembrolizumab group and 6 [10%] in the nivolumab group) and hypertriglyceridaemia (three [6%] in the pembrolizumab group and eight [14%] in the nivolumab group).","[{'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Naing', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA. Electronic address: anaing@mdanderson.org.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Infante', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'W Michael', 'Initials': 'WM', 'LastName': 'Korn', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kyriakos P', 'Initials': 'KP', 'LastName': 'Papadopoulos', 'Affiliation': 'START Center for Cancer Care, San Antonio, TX, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Autio', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Pant', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA; Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Drakaki', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Naval G', 'Initials': 'NG', 'LastName': 'Daver', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hung', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Ratti', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McCauley', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Vlasselaer', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferry', 'Affiliation': 'Eli Lilly and Company, New York City, NY, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Oft', 'Affiliation': 'ARMO BioSciences, Redwood City, CA, USA; Synthkine, Menlo Park, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Diab', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, TRIO-US, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30514-5'] 1438,31837195,Intervention with erythropoietin in sarcopenic patients with femoral intertrochanteric fracture and its potential effects on postoperative rehabilitation.,"AIM To explore the intervention with erythropoietin (EPO) in sarcopenic patients with femoral intertrochanteric fractures, and its potential effects on postoperative rehabilitation. METHODS A total of 141 patients with femoral intertrochanteric fracture were selected from January 2018 to January 2019. Patients (aged ≥60 years) with indications for EPO use, but without significant medical history, were selected in the present study. All patients were screened for sarcopenia, and divided into the intervention group and control group according to whether they took EPO. The intervention groups received EPO postoperatively every day for 10 days, whereas the control groups received an equal dose of normal saline. Patients' handgrip strength, appendicular skeletal muscle, duration of hospitalization and postoperative infection rate were assessed by analysis. RESULTS Among sarcopenic women, the handgrip strength was higher in the intervention group than in the control group after a week (P < 0.05). However, no significant effect was found in men (P > 0.05). The appendicular skeletal muscle increment of the intervention group with sarcopenia was markedly increased regardless of sex (P < 0.001). In addition, the postoperative infection rate was lower in the intervention group than the control group (P < 0.05), accompanied by a shorter hospital stay due to EPO administration (P < 0.05). CONCLUSIONS EPO can improve the muscle strength of female patients with sarcopenia during the perioperative period, and increase muscle mass both of women and men. It can improve the symptoms of sarcopenia, but cannot reverse sarcopenia. Additionally, it can reduce the postoperative complications of patients with hip fracture and shorten the length of hospital stay. Therefore, postoperative administration of EPO might potentially promote rapid postoperative rehabilitation. Geriatr Gerontol Int 2020; 20: 150-155.",2020,"In addition, the postoperative infection rate was lower in the intervention group than the control group (P < 0.05), accompanied by a shorter hospital stay due to EPO administration (P < 0.05). ","['141 patients with femoral intertrochanteric fracture were selected from January 2018 to January 2019', 'sarcopenic patients with femoral intertrochanteric fractures', 'sarcopenic patients with femoral intertrochanteric fracture', 'Patients (aged ≥60\u2009years) with indications for EPO use, but without significant medical history, were selected in the present study', 'female patients with sarcopenia']","['erythropoietin (EPO', 'EPO', 'erythropoietin', 'control groups received an equal dose of normal saline']","['postoperative infection rate', 'shorter hospital stay due to EPO administration', 'muscle strength', 'length of hospital stay', 'postoperative complications', 'appendicular skeletal muscle increment', 'handgrip strength, appendicular skeletal muscle, duration of hospitalization and postoperative infection rate', 'handgrip strength']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",141.0,0.0143041,"In addition, the postoperative infection rate was lower in the intervention group than the control group (P < 0.05), accompanied by a shorter hospital stay due to EPO administration (P < 0.05). ","[{'ForeName': 'Yiou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Wenzhou Medical University Affiliated Cixi Hospital, Ningbo, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'University of Melbourne Medical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}]",Geriatrics & gerontology international,['10.1111/ggi.13845'] 1439,32492688,"Prior Therapeutic Experiences, Not Expectation Ratings, Predict Placebo Effects: An Experimental Study in Chronic Pain and Healthy Participants.","INTRODUCTION Many clinical trials fail because of placebo responses. Prior therapeutic experiences and patients' expectations may affect the capacity to respond to placebos in chronic disorders. OBJECTIVE The scope of this study in 763 chronic orofacial pain and healthy study participants was to compare the magnitude and prevalence of placebo effects and determine the putative role of prior therapeutic experiences vs. expectations. METHODS We tested placebo propensity in a laboratory setting by using 2 distinct levels of individually tailored painful stimulations (high pain and low pain) to reinforce expectations and provide a hypoalgesic experience (conditioning phase). Afterwards, both levels of pain were surreptitiously set at a moderate pain level to test for placebo effects (testing phase). Pain and expectation ratings were assessed as primary outcomes using visual analog scales. RESULTS In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants. Although chronic pain participants reported higher pain relief expectations, expectations did not account for the occurrence of placebo effects. Rather, prior experience via conditioning strength mediated placebo effects in both pain and healthy participants. CONCLUSIONS These findings indicate that participants with chronic pain conditions display robust placebo effects that are not mediated by expectations but are instead directly linked to prior therapeutic experiences. This confirms the importance of assessing the therapeutic history while raising questions about the utility of expectation ratings. Future research is needed to enhance prediction of responses to placebos, which will ultimately improve clinical trial designs.",2020,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","['763 chronic orofacial pain and healthy study participants', 'Chronic Pain and Healthy Participants', 'participants with chronic pain conditions', 'pain and healthy participants']",['placebo'],"['pain relief expectations', 'Pain and expectation ratings', 'visual analog scales']","[{'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",763.0,0.306134,"In both chronic pain and healthy participants, placebo effects were similar in magnitude, with the larger prevalence of responders in the healthy participants.","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA, colloca@umaryland.edu.'}, {'ForeName': 'Titilola', 'Initials': 'T', 'LastName': 'Akintola', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Maxie', 'Initials': 'M', 'LastName': 'Blasini', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Lieven A', 'Initials': 'LA', 'LastName': 'Schenk', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, Maryland, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000507400'] 1440,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited. METHODS We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed. RESULTS Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion. CONCLUSIONS Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion. ","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion. ","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315'] 1441,31565952,Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: a randomized controlled trial.,"OBJECTIVE To determine the effectiveness of silicone and pressure garments (alone and in combination) in children receiving scar management post-burn. DESIGN Multicentre, parallel-group, randomized controlled trial. SETTING Hospital outpatient clinics, colocated research centre, or the participant's home. PARTICIPANTS Children (0-18 years) referred for burn scar management. INTERVENTIONS Participants were randomized to (1) topical silicone gel only, (2) pressure garment therapy only, or (3) combined topical silicone gel and pressure garment therapy. MAIN MEASURES Primary outcomes included scar thickness and itch intensity at the primary end-point of six months post-burn injury. The outcome assessor and data analyst were blinded for scar thickness. RESULTS Participants ( N  = 153; silicone n  = 51, pressure n  = 49, combined n  = 53) had a median (inter-quartile range) age of 4.9 (1.6, 10.2) years and percent total body surface area burn of 1% (0.5%, 3%) and were 65% male. At six months post-burn injury, intention-to-treat analysis identified thinner scars in the silicone ( n  = 51 scar sites) compared to the combined group ( n  = 48 scar sites; mean difference (95% confidence interval) = -0.04 cm (-0.07, -0.00), P  = 0.05). No other between-group differences were identified for scar thickness or itch intensity at six months post-burn. CONCLUSION No difference was identified in the effectiveness of silicone and pressure interventions alone. No benefit to a combined silicone and pressure intervention was identified for the prevention and management of abnormal scarring in children at six months post-burn injury, compared to the silicone or pressure interventions alone.",2020,"No benefit to a combined silicone and pressure intervention was identified for the prevention and management of abnormal scarring in children at six months post-burn injury, compared to the silicone or pressure interventions alone.","[""Hospital outpatient clinics, colocated research centre, or the participant's home"", 'children', 'Children (0-18\u2009years) referred for burn scar management', 'children receiving scar management post-burn', 'Participants ( N \u2009=\u2009153; silicone n \u2009=\u200951, pressure n \u2009=\u200949, combined n \u2009=\u200953) had a median (inter-quartile range) age of 4.9 (1.6, 10.2) years and percent total body surface area burn of 1% (0.5%, 3%) and were 65% male']","['combined silicone and pressure intervention', 'silicone and pressure garments (alone and in combination', 'topical silicone gel and pressure garment therapy', 'topical silicone gel only, (2) pressure garment therapy only, or (3) combined topical silicone gel and pressure garment therapy']","['scar thickness or itch intensity', 'scar thickness and itch intensity at the primary end-point of six months post-burn injury']","[{'cui': 'C0029916', 'cui_str': 'Ambulatory Care Facilities, Hospital'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036280', 'cui_str': 'Burn scar (morphologic abnormality)'}, {'cui': 'C0556498', 'cui_str': 'Scar management (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1283059', 'cui_str': 'Pressure garments'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0599034', 'cui_str': 'Silicone Gels'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}]",51.0,0.0957399,"No benefit to a combined silicone and pressure intervention was identified for the prevention and management of abnormal scarring in children at six months post-burn injury, compared to the silicone or pressure interventions alone.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Wiseman', 'Affiliation': ""Children's Burns and Trauma Research Group, Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': ""Department of Occupational Therapy, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Institute of Health and Biomedical Innovation, School of Public Health and Social Work, Queensland University of Technology, Kelvin Grove, QLD, Australia.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Kimble', 'Affiliation': ""Children's Burns and Trauma Research Group, Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dotta', 'Affiliation': ""Department of Medical Imaging and Nuclear Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Zephanie', 'Initials': 'Z', 'LastName': 'Tyack', 'Affiliation': ""Children's Burns and Trauma Research Group, Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.""}]",Clinical rehabilitation,['10.1177/0269215519877516'] 1442,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences. METHODS Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day. RESULTS On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. CONCLUSIONS Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077'] 1443,27412789,Dopaminergic receptor blockade changes a functional connectivity network centred on the amygdala.,"Resting-state connectivity has become an increasingly important measure in characterizing the functional integrity of brain circuits in neuro-psychiatric conditions. One approach that has recently gained prominence in this regard-and which we use in this study-is to investigate how resting-state connectivity depends on the integrity of certain neuromodulator systems. Here, we use a pharmacological challenge in combination with functional magnetic resonance imaging to investigate the impact of dopaminergic receptor blockade on whole brain functional connectivity in twenty healthy human subjects. Administration of the D2-receptor antagonist haloperidol led to a profound change in functional integration in network nodes linked to the amygdala. Compared to placebo and baseline measurements, network-based statistics and pairwise connectivity analyses revealed reduced connectivity and decreased link strength between the amygdala and the bilateral posterior cingulate cortex and other cortical areas. This was complemented by less extensive but very circumscribed enhanced connectivity between the amygdala and the right putamen during D2-receptor blockade. It will be interesting to investigate whether these pharmacologically induced shifts in resting-state connectivity will similarly be evident in clinical conditions that involve a dysfunction of the dopaminergic system. Our findings might also aid in interpreting alterations in more complex states, such as those seen psychiatric conditions and their treatment. Hum Brain Mapp 37:4148-4157, 2016. © 2016 Wiley Periodicals, Inc.",2016,"Compared to placebo and baseline measurements, network-based statistics and pairwise connectivity analyses revealed reduced connectivity and decreased link strength between the amygdala and the bilateral posterior cingulate cortex and other cortical areas.","['2016', 'twenty healthy human subjects']","['D2-receptor antagonist haloperidol', 'placebo', 'dopaminergic receptor blockade']",['link strength'],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",[],20.0,0.0317574,"Compared to placebo and baseline measurements, network-based statistics and pairwise connectivity analyses revealed reduced connectivity and decreased link strength between the amygdala and the bilateral posterior cingulate cortex and other cortical areas.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Haaker', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. jan.haaker@ki.se.'}, {'ForeName': 'Mareike M', 'Initials': 'MM', 'LastName': 'Menz', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Tahmine', 'Initials': 'T', 'LastName': 'Fadai', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Eippert', 'Affiliation': 'FMRIB Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Büchel', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Human brain mapping,['10.1002/hbm.23302'] 1444,27342447,Effects of ketamine on brain function during smooth pursuit eye movements.,"The uncompetitive NMDA receptor antagonist ketamine has been proposed to model symptoms of psychosis. Smooth pursuit eye movements (SPEM) are an established biomarker of schizophrenia. SPEM performance has been shown to be impaired in the schizophrenia spectrum and during ketamine administration in healthy volunteers. However, the neural mechanisms mediating SPEM impairments during ketamine administration are unknown. In a counter-balanced, placebo-controlled, double-blind, within-subjects design, 27 healthy participants received intravenous racemic ketamine (100 ng/mL target plasma concentration) on one of two assessment days and placebo (intravenous saline) on the other. Participants performed a block-design SPEM task during functional magnetic resonance imaging (fMRI) at 3 Tesla field strength. Self-ratings of psychosis-like experiences were obtained using the Psychotomimetic States Inventory (PSI). Ketamine administration induced psychosis-like symptoms, during ketamine infusion, participants showed increased ratings on the PSI dimensions cognitive disorganization, delusional thinking, perceptual distortion and mania. Ketamine led to robust deficits in SPEM performance, which were accompanied by reduced blood oxygen level dependent (BOLD) signal in the SPEM network including primary visual cortex, area V5 and the right frontal eye field (FEF), compared to placebo. A measure of connectivity with V5 and FEF as seed regions, however, was not significantly affected by ketamine. These results are similar to the deviations found in schizophrenia patients. Our findings support the role of glutamate dysfunction in impaired smooth pursuit performance and the use of ketamine as a pharmacological model of psychosis, especially when combined with oculomotor biomarkers. Hum Brain Mapp 37:4047-4060, 2016. © 2016 Wiley Periodicals, Inc.",2016,"Ketamine administration induced psychosis-like symptoms, during ketamine infusion, participants showed increased ratings on the PSI dimensions cognitive disorganization, delusional thinking, perceptual distortion and mania.","['27 healthy participants received', '2016', 'healthy volunteers']","['placebo', 'Smooth pursuit eye movements (SPEM', 'intravenous racemic ketamine', 'ketamine', 'Ketamine', 'placebo (intravenous saline']","['psychosis-like symptoms', 'PSI dimensions cognitive disorganization, delusional thinking, perceptual distortion and mania', 'brain function', 'blood oxygen level dependent (BOLD) signal in the SPEM network including primary visual cortex, area V5 and the right frontal eye field (FEF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034158', 'cui_str': 'Pursuit, Smooth'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0030976', 'cui_str': 'Perceptual distortions'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038446', 'cui_str': 'Striate Cortex'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C3498745', 'cui_str': 'Frontal Eye Fields'}]",27.0,0.177563,"Ketamine administration induced psychosis-like symptoms, during ketamine infusion, participants showed increased ratings on the PSI dimensions cognitive disorganization, delusional thinking, perceptual distortion and mania.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Steffens', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Neumann', 'Affiliation': 'Department of Anesthesiology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Kasparbauer', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Meyhöfer', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Bonn, Germany.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry and Division of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany. ulrich.ettinger@uni-bonn.de.'}]",Human brain mapping,['10.1002/hbm.23294'] 1445,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma. METHODS This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857. FINDINGS Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths. INTERPRETATION Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma. FUNDING Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1'] 1446,32416073,"Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study.","BACKGROUND Patients with advanced or metastatic oesophageal squamous cell carcinoma have poor prognosis and few treatment options after first-line therapy. We aimed to assess efficacy and safety of the anti-PD-1 antibody camrelizumab versus investigator's choice of chemotherapy in previously treated patients. METHODS ESCORT is a randomised, open-label, phase 3 study of patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy. Patients were randomly assigned (1:1) to camrelizumab (200 mg every 2 weeks) or chemotherapy with docetaxel (75 mg/m 2 every 3 weeks) or irinotecan (180 mg/m 2 every 2 weeks), all given intravenously. Central randomisation was done using the Randomization and Trial Supply Management system with block size randomly generated as four or six and stratified by disease and ECOG performance status. The primary endpoint was overall survival, assessed in randomised patients who had received at least one dose of treatment. Safety was assessed in all treated patients. The trial is registered with ClinicalTrials.gov, NCT03099382, and is closed to new participants. FINDINGS From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients were randomly assigned to treatment, of whom 228 received camrelizumab treatment and 220 received chemotherapy. As of data cutoff on May 6, 2019, with a median follow-up time of 8·3 months (IQR 4·1-12·8) in the camrelizumab group and 6·2 months (3·6-10·1) in the chemotherapy group, median overall survival was 8·3 months (95% CI 6·8-9·7) in the camrelizumab group and 6·2 months (5·7-6·9) in the chemotherapy group (hazard ratio 0·71 [95% CI 0·57-0·87]; two-sided p=0·0010). The most common treatment-related adverse events of grade 3 or worse were anaemia (camrelizumab vs chemotherapy: six [3%] vs 11 [5%]), abnormal hepatic function (four [2%] vs one [<1%]), and diarrhoea (three [1%] vs nine [4%]). Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group. Ten treatment-related deaths occurred, seven (3%) in the camrelizumab group (three deaths from unknown causes, one enterocolitis, one hepatic function abnormal, one pneumonitis, and one myocarditis) and three (1%) in the chemotherapy group (two deaths from unknown causes, and one gastrointestinal haemorrhage). INTERPRETATION Second-line camrelizumab significantly improved overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma compared with chemotherapy, with a manageable safety profile. It might represent a potential option of standard second-line treatment for patients with oesophageal squamous cell carcinoma in China. FUNDING Jiangsu Hengrui Medicine.",2020,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","['Patients with advanced or metastatic oesophageal squamous cell carcinoma', 'Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and had progressed on, or were intolerant to, first-line standard therapy', 'From May 10, 2017, to July 24, 2018, 457 (75%) of 607 screened patients', 'advanced or metastatic oesophageal squamous cell carcinoma (ESCORT', 'patients with oesophageal squamous cell carcinoma in China', 'patients with advanced or metastatic oesophageal squamous cell carcinoma', 'patients aged 18 to 75 years with a histological or cytological diagnosis of advanced or metastatic oesophageal squamous cell carcinoma done at 43 hospitals in China', 'previously treated patients']","['anti-PD-1 antibody camrelizumab', 'camrelizumab', 'chemotherapy with docetaxel', 'Camrelizumab', 'camrelizumab treatment and 220 received chemotherapy', 'chemotherapy', 'irinotecan']","['Safety', 'overall survival', 'diarrhoea', 'efficacy and safety', 'median overall survival', 'adverse events', 'deaths', 'abnormal hepatic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]",,0.242005,"Serious treatment-related adverse events occurred in 37 (16%) of 228 patients in the camrelizumab group, and in 32 (15%) of 220 patients in the chemotherapy group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, Cancer Center, Fifth Medical Center General Hospital of PLA, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Medical Oncology, Fujian Province Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Helong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Oncology Department, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zuoxing', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Internal Medicine Ward 4, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kangsheng', 'Initials': 'K', 'LastName': 'Gu', 'Affiliation': 'Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Oncology Department, The First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': ""Oncology Center, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Radiotherapy, 900 Hospital of the Joint Logistics Team, Fuzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'The Oncology Department, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiotherapy, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xianbao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Department of Medical Oncology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Integrated Chinese and Western Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Medical Oncology, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30110-8'] 1447,32416145,Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.,"OBJECTIVE To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. STUDY DESIGN We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information. RESULTS Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days. CONCLUSIONS Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use. IMPLICATIONS A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.",2020,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"['Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy', 'healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups']","['contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate', '90-day contraceptive vaginal ring releasing estradiol and segesterone acetate', '2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information', 'segesterone acetate (SA']","['zero median unscheduled bleeding or spotting days', 'withdrawal bleeding', 'median E2 concentrations', 'Median serum E2 concentrations', 'serum estradiol (E2) concentrations', 'zero median unscheduled bleeding']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C4723383', 'cui_str': 'Segesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",65.0,0.194795,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mejchen@ucdavis.edu.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Reproductive Medicine Research, Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Health Decisions, Durham, NC, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}]",Contraception,['10.1016/j.contraception.2020.05.004'] 1448,27257980,"A comparison of the effects of Mulligan's mobilization and Kinesio taping on pain, range of motion, muscle strength, and neck disability in patients with cervical spondylosis: A randomized controlled study.","BACKGROUND Cervical Spondylosis (CS) is a degenerative and painful pathology, which needs conservative treatment to relieve symptoms. OBJECTIVE The aim was to investigate the effects of Mulligan's mobilization (MM) and Kinesio taping (KT) on pain, range of motion (ROM), muscle strength, and function in CS. METHODS Forty-five subjects were randomly placed into three groups: Group 1: control group (conventional rehabilitation-CR); Group 2: MM and CR; Group 3: KT and CR. Assessments including neck pain, cervical ROM, muscle strength and Neck Disability index (NDI) were conducted at baseline, after three-week treatment, and at one-month follow up. Results were analyzed using ANCOVA. RESULTS In all groups, pain and NDI scores reduced, cervical ROM and muscle strength increased with time (p< 0.001). Greater improvements in neck extension, left and right rotation were obtained in the KT and MM groups when compared to the control group (p< 0.05). In the KT group, improvement in right lateral flexion ROM was greater than the control and deep cervical flexor muscle strength was greater than the MM and the control groups (p< 0.05). CONCLUSION KT and MM contributed to CR for increasing cervical ROM and deep cervical flexor muscle strength in patients with CS.",2016,"Greater improvements in neck extension, left and right rotation were obtained in the KT and MM groups when compared to the control group (p< 0.05).","['Forty-five subjects', 'patients with cervical spondylosis', 'patients with CS']","[""Mulligan's mobilization and Kinesio taping"", 'control group (conventional rehabilitation-CR); Group 2: MM and CR', ""Mulligan's mobilization (MM) and Kinesio taping (KT""]","['neck extension, left and right rotation', 'pain, range of motion, muscle strength, and neck disability', 'pain and NDI scores reduced, cervical ROM and muscle strength', 'cervical ROM and deep cervical flexor muscle strength', 'pain, range of motion (ROM), muscle strength, and function in CS', 'neck pain, cervical ROM, muscle strength and Neck Disability index (NDI', 'right lateral flexion ROM', 'deep cervical flexor muscle strength']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis (disorder)'}]","[{'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450415', 'cui_str': 'Lateral to the right (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",45.0,0.0241603,"Greater improvements in neck extension, left and right rotation were obtained in the KT and MM groups when compared to the control group (p< 0.05).","[{'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Copurgensli', 'Affiliation': 'Bayındır Hospital, Sogutozu, Ankara, Turkey.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Gur', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Volga Bayrakcı', 'Initials': 'VB', 'LastName': 'Tunay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,[] 1449,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants. METHODS By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood. RESULTS Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood. CONCLUSIONS The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916'] 1450,26749356,Visual presentations of efficacy data in direct-to-consumer prescription drug print and television advertisements: A randomized study.,"OBJECTIVE To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. METHODS Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. RESULTS For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. CONCLUSION Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. PRACTICE IMPLICATIONS Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work.",2016,"RESULTS For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall.",['Individuals diagnosed with high cholesterol (n=2504'],"['DTC print and television advertisements', 'direct-to-consumer prescription drug print and television advertisements', 'fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph', 'visual aids']","['drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions', 'drug efficacy recall', 'accurate drug efficacy recall']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0344218', 'cui_str': 'Visual aid (procedure)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}]",2504.0,0.0575835,"RESULTS For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall.","[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'U.S Food and Drug Administration, Silver Spring, MD, United States. Electronic address: Helen.Sullivan@fda.hhs.gov.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'U.S Food and Drug Administration, Silver Spring, MD, United States.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'U.S Food and Drug Administration, Silver Spring, MD, United States.'}, {'ForeName': 'Dhuly', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Moultrie', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States.'}]",Patient education and counseling,['10.1016/j.pec.2015.12.015'] 1451,32416333,Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.,"Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.",2020,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"['symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD', '153 subjects at 27 centers are treated in the study', 'patients with longstanding persistent AF', 'patients with left atrial sizes up to 6 centimeters']","['minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation', 'catheter ablation', 'Epicardial and Endocardial RF Ablation', 'endocardial catheter ablation']","['freedom from AF/AFL/AF absent class I/III AAD', 'incidence of major adverse events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0475210', 'cui_str': 'cm'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014124', 'cui_str': 'Endocardial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",153.0,0.021211,AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF.,"[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'DeLurgio', 'Affiliation': ""Emory St. Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}, {'ForeName': 'Jaswinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Blauth', 'Affiliation': ""Guy's and St. Thomas's Hospital, London, UK.""}, {'ForeName': 'Saumil', 'Initials': 'S', 'LastName': 'Oza', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mostovych', 'Affiliation': ""St Vincent's Medical Center, Jacksonville, FL.""}, {'ForeName': 'Yashasvi', 'Initials': 'Y', 'LastName': 'Awasthi', 'Affiliation': 'AtriCure, Inc., Mason, OH. Electronic address: yawasthi@atricure.com.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc., Mason, OH.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Crossen', 'Affiliation': 'North Mississippi Medical Center, Tupelo, MS.'}]",American heart journal,['10.1016/j.ahj.2020.02.016'] 1452,32416406,The effect of a running training intervention on ankle power generation in children and adolescents with cerebral palsy: A randomized controlled trial.,"BACKGROUND Children and adolescents with cerebral palsy who are classified as Gross Motor Function Classification Scale level I or II are usually able to run but lack ankle power generation for push-off. The aim of this study was to analyze the efficacy of a running training program in improving ankle power generation in children and adolescents with cerebral palsy. METHODS This randomized controlled trial compared kinematic and spatiotemporal data collected during running from 38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program. Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy were calculated. Linear mixed models were developed to analyze differences between groups. FINDINGS At follow-up the intervention group had increased normalized speed of running (t = -3.68 p < .01) while the control group got slower (t = 3.17 p < .01). In running, children in Gross Motor Function Classification Scale level II in the intervention group increased ankle power (t = 2.49 p = .01) while the control group did not change (t = 0.38 p = .71). In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level I t = 0.32 p = .75; level II t = 1.56 p = .12) while those in the control group decreased ankle power (level I t = 4.69 p < .01; level II t = 2.52 p = .01). Most within-group differences did not result in significant between-group differences at follow-up. INTERPRETATION Power generation for running may be responsive to targeted intervention in children with cerebral palsy.",2020,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","['38 children and adolescents with unilateral or bilateral cerebral palsy before and after a 12-week running program', 'children with cerebral palsy', 'Children and adolescents with cerebral palsy', 'children and adolescents with cerebral palsy']","['running training program', 'running training intervention']","['normalized speed of running', 'Normalized speed, stride length, cadence, foot strike pattern, peak ankle power generation, peak hip flexor power generation in swing and propulsion strategy', 'Gross Motor Function Classification Scale level', 'ankle power (level', 'ankle power']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",38.0,0.0435438,"In sprinting, children in Gross Motor Function Classification Scale levels I and II in the intervention group maintained ankle power (level","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chappell', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia. Electronic address: annie.chappell@abilitycentre.com.au.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Allison', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of Melbourne, Victoria, Australia; Epworth HealthCare, Victoria, Australia. Electronic address: gavin.williams@epworth.org.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': ""School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia; Ability Centre, Coolbinia, Western Australia, Australia; Perth Children's Hospital, Perth, Western Australia, Australia. Electronic address: noula.gibson@health.wa.gov.au.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia, Australia.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105024'] 1453,31843831,"Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam.","INTRODUCTION Economic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available. METHODS AND ANALYSIS Although significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant's development, infant's health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit-cost ratios. ETHICS AND DISSEMINATION The trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016-0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations. TRIAL REGISTRATION NUMBER ACTRN12617000442303.",2019,This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam.,"['Vietnam', ""women's health and infant's health and development in Vietnam"", '1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation']","['Learning Clubs, a multicomponent intervention', 'Learning Clubs programme']",[],"[{'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0205806', 'cui_str': 'Baby Health'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}]",[],1008.0,0.218752,This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam.,"[{'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ""Global and Women's Health, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Sweeny', 'Affiliation': 'VISES, Victoria University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thach', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Global and Women's Health, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Centre for International Health, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Hipgrave', 'Affiliation': 'UNICEF, New York City, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hanieh', 'Affiliation': 'Department of Medicine and Victorian Infectious Diseases Service at the Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Research and Training Centre for Community Development, Hanoi, Viet Nam.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Research and Training Centre for Community Development, Hanoi, Viet Nam.'}, {'ForeName': 'Beverley-Ann', 'Initials': 'BA', 'LastName': 'Biggs', 'Affiliation': 'Medicine, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': ""Global and Women's Health, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia jane.fisher@monash.edu.""}]",BMJ open,['10.1136/bmjopen-2019-031721'] 1454,30427289,A controlled trial using a factorial design reported in 1946.,,2018,,[],[],[],[],[],[],,0.0847631,,"[{'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Pollock', 'Affiliation': 'Faculty of Health and Social Care, University of the West of England, Bristol, Blackberry Hill, Stapleton, Bristol BS16 1DD, UK.'}]",Journal of the Royal Society of Medicine,['10.1177/0141076818808491'] 1455,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity. METHODS Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy. FINDINGS 152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases. INTERPRETATION Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039'] 1456,31499240,Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention.,"BACKGROUND This study investigated the effects of a multi-level smoking intervention on mediators of long-term abstinence in parental smokers, including smoking cessation self-efficacy, smoking urge coping, and perceived support to quit smoking. METHODS This is a secondary analysis of data from a randomized trial that recruited parental smokers from pediatric clinics in low-income communities (N = 327, 83% women, 83% African American, 79% below poverty level). Following clinical practice guidelines for tobacco intervention (""Ask, Advise, Refer"" [AAR]), pediatricians asked all parents about child tobacco smoke exposure (TSE), advised about TSE harms and benefits of reducing TSE, and referred smokers to cessation resources. Eligible parents were then randomized to additional telephone-based smoking behavior counseling (AAR + counseling) or nutrition education (AAR + control). Bioverified 7-day point prevalence smoking abstinence and perceived counselor support were assessed at 12-month follow-up; cessation self-efficacy and urge coping were assessed at 3-month follow-up. RESULTS Relative to AAR + control, AAR + counseling was associated with higher self-efficacy, urge coping, and perceived support to quit (all p's<.001). Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001). The indirect effect of intervention on 12-month abstinence via self-efficacy suggested mediation via this pathway (p = .002). CONCLUSION Results suggest that all putative treatment pathways were improved more by the multi-level AAR + counseling than the clinic-level AAR + control intervention. Further, self-efficacy at end-of-treatment prospectively predicted long-term cessation, suggesting that building of self-efficacy through treatment may be key to sustained cessation.",2019,"Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001).","['parental smokers', 'recruited parental smokers from pediatric clinics in low-income communities (N\u2009=\u2009327, 83% women, 83% African American, 79% below poverty level', 'low-income parents in the multilevel Kids Safe and Smokefree intervention', 'Eligible parents']","['telephone-based smoking behavior counseling (AAR\u2009+\u2009counseling) or nutrition education (AAR\u2009+\u2009control', 'multi-level smoking intervention']","['cessation self-efficacy and urge coping', 'higher self-efficacy, urge coping, and perceived support to quit', 'smoking cessation self-efficacy, smoking urge coping', '12-month bioverified smoking abstinence', 'Self-efficacy']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0254556,"Self-efficacy, but no other mediators, had a significant positive effect on 12-month bioverified smoking abstinence (p < .001).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Lepore', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Ave, 9th Floor Ritter Annex, Philadelphia, PA 19122, USA. Electronic address: slepore@temple.edu.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Ave, 9th Floor Ritter Annex, Philadelphia, PA 19122, USA. Electronic address: collinsb@temple.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sosnowski', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 W. Franklin St, Box 842018, Richmond, VA 23284, USA. Electronic address: sosnowskid@mymail.vcu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.05.027'] 1457,32416432,Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.,"OBJECTIVE Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer. MATERIAL AND METHODS We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO 2 peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression. RESULTS There was no significant difference between the intervention and control groups in VO 2 peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression. CONCLUSION There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO 2 peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.",2020,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"['patients with various types of cancer', 'patients with advanced inoperable lung cancer', '218 patients with advanced inoperable lung cancer', 'patients with advanced inoperable lung cancer undergoing']","['chemotherapy', 'exercise intervention', 'structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care']","['muscle strength outcomes', 'social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression', 'VO 2 peak', 'level of anxiety and depression', 'maximal oxygen uptake (VO 2 peak', 'muscle strength', 'muscle strength, functional capacity, forced expiratory volume in 1\u2009s, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",218.0,0.0758603,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark. Electronic address: morten.quist@regionh.dk.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Lærke', 'Initials': 'L', 'LastName': 'Winther', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Jørgen H', 'Initials': 'JH', 'LastName': 'Laursen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark; Department of Public Health, University of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.003'] 1458,26821769,The effects of low-dose ketamine on the prefrontal cortex and amygdala in treatment-resistant depression: A randomized controlled study.,"BACKGROUND Low-dose ketamine has been found to have robust and rapid antidepressant effects. A hypoactive prefrontal cortex (PFC) and a hyperactive amygdala have been suggested to be associated with treatment-resistant depression (TRD). However, it is unclear whether the rapid antidepressant mechanisms of ketamine on TRD involve changes in glutamatergic neurotransmission in the PFC and the amygdala. METHODS A group of 48 TRD patients were recruited and equally randomized into three groups (A: 0.5 kg/mg-ketamine; B: 0.2 kg/mg-ketamine; and C: normal saline [NS]). Standardized uptake values (SUV) of glucose metabolism measured by (18) F-FDG positron-emission-tomography before and immediately after a 40-min ketamine or NS infusion were used for subsequent region-of-interest (ROI) analyses (a priori regions: PFC and amygdala) and whole-brain voxel-wise analyses and were correlated with antidepressant responses, as defined by the Hamilton depression rating scale score. The (18) F-FDG signals were used as a proxy measure of glutamate neurotransmission. RESULTS The ROI analysis indicated that Group A and Group B, but not Group C, had increases in the SUV of the PFC (group-by-time interaction: F = 7.373, P = 0.002), whereas decreases in the SUV of the amygdala were observed in all three groups (main effect of time, P < 0.001). The voxel-wise analysis further confirmed a significant group effect on the PFC (corrected for family-wise errors, P < 0.05; post hoc analysis: Group A35 kg/m2 were excluded. Participants were randomized to one of the 3 groups: LMA CTrach, LMA Fastrach, or the Macintosh laryngoscope. C-spine motion was evaluated by measuring angles created by bordering vertebrae at cervical 1/2 and 2/3 (C1/2, C2/3) segments on 2 lateral cervical radiographs for each patient. Intubation time, ease of intubation, number of attempts, and success rate were also documented. Results Demographic data were similar in all the groups. The cervical movement with LMA CTrach and LMA Fastrach compared to the Macintosh laryngoscope were similar at C1/2. However, LMA CTrach significantly reduced extension compared to LMA Fastrach and Macintosh laryngoscopes at C2/3. Duration of intubation was significantly shorter with the Macintosh laryngoscope. The rate of successful intubation was 80% with LMA Fastrach and 100% with both LMA CTrach and the Macintosh laryngoscopes. Conclusion The LMA CTrach laryngoscopy involves less upper C-spine movement than the LMA Fastrach and does not increase the duration of the intubation period.",2019,The cervical movement with LMA CTrach and LMA Fastrach compared to Macintosh laryngoscope were similar at C1/2.,"['Sixty patients scheduled for elective cervical surgery', 'patients with cervical pathology', 'Patients with cervical trauma/injury, previous neck surgery, and BMI>35kg/m2 were excluded']","['LMA CTrach laryngoscopy', 'LMA CTrach, LMA Fastrach or Macintosh laryngoscope', 'LMA Fastrach, LMA CTrach and Macintosh laryngoscope', 'radiography']","['intubation time, ease of intubation, number of attempts and success rate', 'C-spine motion', 'Rate of successful intubation', 'Duration of intubation']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",60.0,0.0759505,The cervical movement with LMA CTrach and LMA Fastrach compared to Macintosh laryngoscope were similar at C1/2.,"[{'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Inan', 'Affiliation': ''}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Bedirli', 'Affiliation': ''}, {'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Ozkose Satirlar', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-1906-135'] 1463,26757368,Behavioural and neurofunctional impact of transcranial direct current stimulation on somatosensory learning.,"We investigated the effect of repeated delivery of anodal transcranial direct current stimulation (tDCS) on somatosensory performance and long-term learning. Over the course of five days, tDCS was applied to the primary somatosensory cortex (S1) by means of neuronavigation employing magnetencephalography (MEG). Compared to its sham application, tDCS promoted tactile learning by reducing the two-point discrimination threshold assessed by the grating orientation task (GOT) primarily by affecting intersessional changes in performance. These results were accompanied by alterations in the neurofunctional organization of the brain, as revealed by functional magnetic resonance imaging conducted prior to the study, at the fifth day of tDCS delivery and four weeks after the last application of tDCS. A decrease in activation at the primary site of anodal tDCS delivery in the left S1 along retention of superior tactile acuity was observed at follow-up four weeks after the application of tDCS. Thus, we demonstrate long-term effects that repeated tDCS imposes on somatosensory functioning. This is the first study to provide insight into the mode of operation of tDCS on the brain's response to long-term perceptual learning, adding an important piece of evidence from the domain of non-invasive brain stimulation to show that functional changes detectable by fMRI in primary sensory cortices participate in perceptual learning.",2016,"Compared to its sham application, tDCS promoted tactile learning by reducing the two-point discrimination threshold assessed by the grating orientation task (GOT) primarily by affecting intersessional changes in performance.",[],"['anodal transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation']","['activation', 'somatosensory learning', 'tactile learning', 'somatosensory performance and long-term learning', 'superior tactile acuity']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0582588', 'cui_str': 'Tactile learning (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}]",,0.0183136,"Compared to its sham application, tDCS promoted tactile learning by reducing the two-point discrimination threshold assessed by the grating orientation task (GOT) primarily by affecting intersessional changes in performance.","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hilgenstock', 'Affiliation': 'Hans Berger Department of Neurology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weiss', 'Affiliation': 'Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Huonker', 'Affiliation': 'Brain Imaging Center, Hans Berger Department of Neurology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.'}, {'ForeName': 'Otto W', 'Initials': 'OW', 'LastName': 'Witte', 'Affiliation': 'Hans Berger Department of Neurology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.'}]",Human brain mapping,['10.1002/hbm.23101'] 1464,30472801,Perinatal probiotic intervention prevented allergic disease in a Caesarean-delivered subgroup at 13-year follow-up.,"BACKGROUND The long-term effects of probiotic intervention for primary prevention of allergic diseases are not well known. We previously reported less eczema until 10 years in our probiotic intervention trial. OBJECTIVE To investigate the effect of early probiotic intervention on the prevalence of allergic diseases up to 13 years of age. METHODS Pregnant women (n = 1223) carrying a child at a high risk of allergy (at least one parent with allergic disease) were randomized to receive a mixture of probiotics (Lactobacillus rhamnosusGG and LC705, Bifidobacterium breve Bb99 and Propionibacterium freudenreichii) or placebo in a double-blind manner from 36 weeks of gestation until birth. Their infants received the same product for the first six months (registration number NCT00298337). At 13-year follow-up, the participants were requested to return a questionnaire and to provide a blood sample. RESULTS A questionnaire was returned by 642 participants (63.1% of intention-to-treat infants), and 459 provided a blood sample. In the whole cohort, there were no statistically significant differences in doctor-diagnosed allergic disease (55.2% and 59.0%, probiotic and placebo group, respectively) or allergic disease (47.9% and 51.6%) based on the ISAAC questionnaire data. Inhalant-specific IgE sensitization (>0.7 kU/L) was 59.3% in the probiotic group and 49.8% in the placebo group (P = 0.040). In a post hoc analysis made in Caesarean-delivered subgroup, allergy was reported in 41.5% of the probiotic group and 67.9% of the placebo group (P = 0.006), and eczema in 18.9% and 37.5%, respectively (P = 0.031). In the whole cohort, 8.5% of the probiotic group had suffered from wheezing attacks during the previous 12 months vs 14.7% in the placebo group (P = 0.013). There were no statistically significant differences discovered between the characteristics of the participating group and the dropout group. CONCLUSIONS Probiotic intervention protected Caesarean-delivered subgroup from allergic disease and eczema, but not the total cohort.",2019,Inhalant-specific IgE sensitization (>0.7 kU/L) was 59.3% in the probiotic group and 49.8% in the placebo group (P = 0.040).,"['allergic diseases up to 13\xa0years of age', '642 participants (63.1% of intention-to-treat infants), and 459 provided a blood sample', 'Pregnant women (n\xa0=\xa01223) carrying a child at a high risk of allergy (at least one parent with allergic disease']","['placebo', 'Perinatal probiotic intervention', 'Probiotic intervention', 'mixture of probiotics (Lactobacillus rhamnosusGG and LC705, Bifidobacterium breve Bb99 and Propionibacterium freudenreichii) or placebo', 'probiotic intervention', 'early probiotic intervention']","['Inhalant-specific IgE sensitization', 'doctor-diagnosed allergic disease', 'wheezing attacks', 'eczema', 'allergic disease']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0317951', 'cui_str': 'Propionibacterium freudenreichii'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}]",1223.0,0.417723,Inhalant-specific IgE sensitization (>0.7 kU/L) was 59.3% in the probiotic group and 49.8% in the placebo group (P = 0.040).,"[{'ForeName': 'Sampo', 'Initials': 'S', 'LastName': 'Kallio', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Anna Kaarina', 'Initials': 'AK', 'LastName': 'Kukkonen', 'Affiliation': 'Skin and Allergy Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Savilahti', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Kuitunen', 'Affiliation': ""Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13321'] 1465,32053027,Board Games on Emotional Competences for School-Age Children.,"Objective: Emotional competences (EC) are important for social and academic outcomes and positive life trajectories. Due to their social setting and tendency to stimulate intrinsic motivation, board games may constitute efficient learning tools for promoting socioemotional development in children. The current project therefore aimed at developing and testing three theory-driven board games explicitly targeting EC. First, we explored the quality of these EC games in terms of game experience, compared to off-the-shelf games (without an EC focus). Second, we tested whether targeted EC were linked to game experience in the EC games by measuring associations between children's trait EC and subjective effort and difficulty during gameplay. Materials and Methods: Children ( N  = 177) aged 8-12 years old were randomly assigned to a four-session protocol that comprised EC board games (experimental group) or off-the-shelf board games (control group). At baseline, participants' trait EC (emotion recognition, differentiation, and cognitive reappraisal) were assessed, while game experience (e.g., positive and negative affect, flow and immersion, difficulty, and effort) was assessed after each game. Results: Both groups perceived the games they played as positive and playable. Furthermore, regression analyses showed that higher trait EC was linked to lower self-reported effort and difficulty in two of the EC board games focusing on emotion recognition and differentiation. Conclusion: The present study shows that the board games on EC designed for children seem to elicit game experiences comparable to off-the-shelf games. Moreover, children's trait EC were linked to subjective game experience in two of the three games. Future interventions should examine the potential of the novel games to promote EC.",2020,"At baseline, participants' trait EC (emotion recognition, differentiation, and cognitive reappraisal) were assessed, while game experience (e.g., positive and negative affect, flow and immersion, difficulty, and effort) was assessed after each game. ","['children', 'Children ( N \u2009=\u2009177) aged 8-12 years old', 'School-Age Children']","['EC board games (experimental group) or off-the-shelf board games (control group', 'Emotional competences (EC']","['trait EC (emotion recognition, differentiation, and cognitive reappraisal']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",177.0,0.0192832,"At baseline, participants' trait EC (emotion recognition, differentiation, and cognitive reappraisal) were assessed, while game experience (e.g., positive and negative affect, flow and immersion, difficulty, and effort) was assessed after each game. ","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': ""Dell'Angela"", 'Affiliation': 'Swiss Center for Affective Sciences, Campus Biotech, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zaharia', 'Affiliation': 'Swiss Center for Affective Sciences, Campus Biotech, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lobel', 'Affiliation': 'Swiss Center for Affective Sciences, Campus Biotech, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Vico Begara', 'Affiliation': 'Faculty of Psychology and Educational Sciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sander', 'Affiliation': 'Swiss Center for Affective Sciences, Campus Biotech, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Samson', 'Affiliation': 'Swiss Center for Affective Sciences, Campus Biotech, University of Geneva, Geneva, Switzerland.'}]",Games for health journal,['10.1089/g4h.2019.0050'] 1466,31551532,Physical activity is associated with functional capacity of older women with osteosarcopenic obesity: 24-month prospective study.,"BACKGROUND/OBJECTIVES Physical activity (PA) could be effective in the prevention of functional disability in older women, especially for those with body composition abnormalities. The aim this study was to analyze the association of total PA and in different domains with physical function and functional capacity in older women with or without osteosarcopenic obesity (OSO), as well as to assess the risk of functional disability in osteosarcopenic obesity older women insufficiently active. SUBJECTS/METHODS The study included 152 Brazilian older women, aged 60 years and older. Body composition was measured by dual energy X-ray absorptiometry (DXA) and physical function by physical tests. Functional capacity and PA were self-reported. RESULTS In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL. In older women with OSO, the practice of leisure-time exercise was inversely associated with physical function (β:0.88; 95%CI 0.31-1.46) and functional capacity (β:-1.05; 95%CI 1.64 to -0.45), while total PA (β:-1.03; 95%CI -1.93 to -0.13) was inversely associated with functional capacity, independent of control variables. In addition, older women with OSO who remained insufficiently active in leisure-time exercise (HR:2.28; 95%CI 1.04-4.99) and locomotion (HR:2.62; 95%CI 1.28-5.36) domains presented risk for functional disability. CONCLUSIONS PA is inversely associated with physical function and functional capacity in older women with or without OSO, and older women with OSO who are insufficiently active in leisure-time exercise and locomotion domains presented a higher risk for functional disability.",2020,"In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL.","['older women with or without OSO, and older women with OSO', '152 Brazilian older women, aged 60 years and older', 'older women with OSO', 'older women with or without osteosarcopenic obesity (OSO', 'older women', 'osteosarcopenic obesity older women insufficiently active', 'older women with osteosarcopenic obesity']",['Physical activity (PA'],"['physical function', 'Body composition', 'functional capacity', 'physical function and functional capacity', 'total PA']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0860006,"In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL.","[{'ForeName': 'Vanessa Ribeiro', 'Initials': 'VR', 'LastName': 'Dos Santos', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, LABSIM, Department of Physical Education, School of Technology and Sciences, São Paulo State University, UNESP, Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Luís Alberto', 'Initials': 'LA', 'LastName': 'Gobbo', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, LABSIM, Department of Physical Education, School of Technology and Sciences, São Paulo State University, UNESP, Presidente Prudente, Sao Paulo, Brazil. luis.gobbo@unesp.br.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0505-y'] 1467,32419703,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. METHODS The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. ETHICS AND DISSEMINATION The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132'] 1468,26605034,Testing Brief Intervention and Phone Contact among Subjects with Suicidal Behavior: A Randomized Controlled Trial in French Polynesia in the Frames of the World Health Organization/Suicide Trends in At-Risk Territories Study.,"The World Health Organization Suicide trends in at-risk territories study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU) or TAU plus Brief Intervention and Contact (BIC), which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless - given its importance - the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country.",2015,At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors.,"['non-fatal suicidal behaviors', 'Those then hospitalized in the Psychiatry Emergency Unit', 'Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior', 'One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group', 'Subjects with Suicidal Behavior']","['Treatment As Usual (TAU) or TAU plus Brief Intervention and Contact (BIC), which provides a psycho-education session']",['number of presentations to the hospital for repeated suicidal behaviors'],"[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0063382', 'cui_str': 'TIC mustard'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}]",515.0,0.0276742,At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors.,"[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Amadéo', 'Affiliation': ''}, {'ForeName': 'Moerani', 'Initials': 'M', 'LastName': 'Rereao', 'Affiliation': 'Centre Hospitalier de Polynésie Française , Tahiti, Polynésie Française.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Malogne', 'Affiliation': 'Centre de Prévention du Suicide de Polynésie Française , Tahiti, Polynésie Française.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Favro', 'Affiliation': 'Université de Polynésie Française , Polynésie Française.'}, {'ForeName': 'Ngoc Lam', 'Initials': 'NL', 'LastName': 'Nguyen', 'Affiliation': 'Direction de la Santé Publique de Polynésie française , Tahiti, Polynésie Française.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Jehel', 'Affiliation': 'Unité Inserm U699 , Paris, France ; Centre Hospitalier Universitaire , Martinique, France.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Milner', 'Affiliation': 'Australian Institute for Suicide Research and Prevention, Griffith University , Brisbane, Australia.'}, {'ForeName': 'Kairi', 'Initials': 'K', 'LastName': 'Kolves', 'Affiliation': 'Australian Institute for Suicide Research and Prevention, Griffith University , Brisbane, Australia.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'De Leo', 'Affiliation': 'Australian Institute for Suicide Research and Prevention, Griffith University , Brisbane, Australia.'}]",Mental illness,['10.4081/mi.2015.5818'] 1469,16816271,"'An innocent deception': placebo controls in the St Petersburg homeopathy trial, 1829-1830.",,2006,,[],[],[],[],[],[],,0.0662343,,"[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Dean', 'Affiliation': 'Department of Health Sciences, Seebohm Rowntree Building, University of York, York YO10 5DD, UK. med5@york.ac.uk'}]",Journal of the Royal Society of Medicine,[] 1470,25721115,Alexander Lesassier Hamilton's 1816 report of a controlled trial of bloodletting.,,2015,,[],[],[],[],[],[],,0.0232859,,"[{'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Milne', 'Affiliation': 'Royal College of Physicians, Edinburgh, EH2 1JQ, UK i.milne@rcpe.ac.uk.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Chalmers', 'Affiliation': 'Summertown Pavilion, Oxford, OX2 7LG, UK.'}]",Journal of the Royal Society of Medicine,['10.1177/0141076814566587'] 1471,27038114,Neurofeedback training of EEG alpha rhythm enhances episodic and working memory.,"Neurofeedback training (NFT) of the alpha rhythm has been used for several decades but is still controversial in regards to its trainability and effects on working memory. Alpha rhythm of the frontoparietal region are associated with either the intelligence or memory of healthy subjects and are also related to pathological states. In this study, alpha NFT effects on memory performances were explored. Fifty healthy participants were recruited and randomly assigned into a group receiving a 8-12-Hz amplitude (Alpha) or a group receiving a random 4-Hz amplitude from the range of 7 to 20 Hz (Ctrl). Three NFT sessions per week were conducted for 4 weeks. Working memory was assessed by both a backward digit span task and an operation span task, and episodic memory was assessed using a word pair task. Four questionnaires were used to assess anxiety, depression, insomnia, and cognitive function. The Ctrl group had no change in alpha amplitude and duration. In contrast, the Alpha group showed a progressive significant increase in the alpha amplitude and total alpha duration of the frontoparietal region. Accuracies of both working and episodic memories were significantly improved in a large proportion of participants of the Alpha group, particularly for those with remarkable alpha-amplitude increases. Scores of four questionnaires fell in a normal range before and after NFT. The current study provided supporting evidence for alpha trainability within a small session number compared with that of therapy. The findings suggested the enhancement of working and episodic memory through alpha NFT. Hum Brain Mapp 37:2662-2675, 2016. © 2016 Wiley Periodicals, Inc.",2016,"Accuracies of both working and episodic memories were significantly improved in a large proportion of participants of the Alpha group, particularly for those with remarkable alpha-amplitude increases.","['Fifty healthy participants', '2016']","['8-12-Hz amplitude (Alpha) or a group receiving a random 4-Hz amplitude from the range of 7 to 20 Hz (Ctrl', 'Neurofeedback training (NFT']","['backward digit span task and an operation span task, and episodic memory', 'Accuracies of both working and episodic memories', 'memory performances', 'alpha amplitude and total alpha duration of the frontoparietal region', 'alpha amplitude and duration', 'anxiety, depression, insomnia, and cognitive function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",50.0,0.0294837,"Accuracies of both working and episodic memories were significantly improved in a large proportion of participants of the Alpha group, particularly for those with remarkable alpha-amplitude increases.","[{'ForeName': 'Jen-Jui', 'Initials': 'JJ', 'LastName': 'Hsueh', 'Affiliation': 'Institute of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Tzu-Shan', 'Initials': 'TS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jia-Jin', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'Institute of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fu-Zen', 'Initials': 'FZ', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, National Cheng Kung University, Tainan, Taiwan.'}]",Human brain mapping,['10.1002/hbm.23201'] 1472,26441146,Abnormal functional integration of thalamic low frequency oscillation in the BOLD signal after acute heroin treatment.,"Heroin addiction is a severe relapsing brain disorder associated with impaired cognitive control, including deficits in attention allocation. The thalamus has a high density of opiate receptors and is critically involved in orchestrating cortical activity during cognitive control. However, there have been no studies on how acute heroin treatment modulates thalamic activity. In a cross-over, double-blind, vehicle-controlled study, 29 heroin-maintained outpatients were studied after heroin and placebo administration, while 20 healthy controls were included for the placebo condition only. Resting-state functional magnetic resonance imaging was used to analyze functional integration of the thalamus by three different resting state analysis techniques. Thalamocortical functional connectivity (FC) was analyzed by seed-based correlation, while intrinsic thalamic oscillation was assessed by analysis of regional homogeneity (ReHo) and the fractional amplitude of low frequency fluctuations (fALFF). Relative to the placebo treatment and healthy controls, acute heroin administration reduced thalamocortical FC to cortical regions, including the frontal cortex, while the reductions in FC to the mediofrontal cortex, orbitofrontal cortex, and frontal pole were positively correlated with the plasma level of morphine, the main psychoactive metabolite of heroin. Furthermore, heroin treatment was associated with increased thalamic ReHo and fALFF values, whereas fALFF following heroin exposure correlated negatively with scores of attentional control. The heroin-associated increase in fALFF was mainly dominated by slow-4 (0.027-0.073 Hz) oscillations. Our findings show that there are acute effects of heroin within the thalamocortical system and may shed new light on the role of the thalamus in cognitive control in heroin addiction. Future research is needed to determine the underlying physiological mechanisms and their role in heroin addiction.",2015,"Relative to the placebo treatment and healthy controls, acute heroin administration reduced thalamocortical FC to cortical regions, including the frontal cortex, while the reductions in FC to the mediofrontal cortex, orbitofrontal cortex, and frontal pole were positively correlated with the plasma level of morphine, the main psychoactive metabolite of heroin.","['20 healthy controls were included for the placebo condition only', '29 heroin-maintained outpatients were studied after']","['placebo', 'heroin and placebo']","['Thalamocortical functional connectivity (FC', 'fALFF', 'thalamic ReHo and fALFF values', 'FC to the mediofrontal cortex, orbitofrontal cortex, and frontal pole']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}]",29.0,0.179667,"Relative to the placebo treatment and healthy controls, acute heroin administration reduced thalamocortical FC to cortical regions, including the frontal cortex, while the reductions in FC to the mediofrontal cortex, orbitofrontal cortex, and frontal pole were positively correlated with the plasma level of morphine, the main psychoactive metabolite of heroin.","[{'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Denier', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Gerber', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vogel', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Huber', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Undine E', 'Initials': 'UE', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Riecher-Rossler', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Gerhard A', 'Initials': 'GA', 'LastName': 'Wiesbeck', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4012, Switzerland.'}]",Human brain mapping,['10.1002/hbm.23011'] 1473,31553204,Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.,"BACKGROUND The use of poly- l -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P =0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P <0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P <0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P =0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P =1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P =0.003). CONCLUSIONS When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.",2019,"Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% vs. -2.4±1.3% in the SES group, p=0.003). ","['at 11 academic centers', 'ST-segment elevation myocardial infarction (STEMI) patients', 'Patients with ST-Segment Elevation Myocardial Infarction', 'Results: Between June 2017 and June 2018, 150 STEMI patients were randomized (MgBRS, n=74; SES, n=76']","['MgBRS and permanent metallic sirolimus-eluting stent (SES', 'nitroglycerin', 'Magnesium-based bioresorbable scaffold (MgBRS', 'acetylcholine', 'Magnesium-Based Resorbable Scaffold versus Permanent Metallic Sirolimus-Eluting Stent', 'SES or MgBRS', 'poly-L lactide acid-based bioresorbable scaffolds', 'SES']","['vasomotor response', 'ischemia-driven target lesion revascularization rate', 'rate of increase', 'Endothelial function assessment', 'vasoconstrictive response', 'late lumen loss', 'angiographic efficacy', 'angiographic parameters of restenosis, the device-oriented composite endpoint, their individual components, and device thrombosis rate', 'Definite thrombosis rate']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0615693', 'cui_str': 'poly(lactide), (L)-isomer'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",150.0,0.177933,"Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% vs. -2.4±1.3% in the SES group, p=0.003). ","[{'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.).'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.).'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Romaní', 'Affiliation': 'Hospital San Pedro de Alcántara, Cáceres, Spain (S.R.).'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Bordes', 'Affiliation': 'Hospital General de Alicante, Alicante, Spain (P.B.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S.).'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.).'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain (P.S.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ""Hospital Vall d'Hebrón, Barcelona, Spain (B.G.D.B.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Goicolea', 'Affiliation': 'Hospital Puerta de Hierro-Majadahonda, Madrid, Spain (J.G.).'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández-Antolín', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain (R.H.A.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.).'}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.).'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega-Paz', 'Affiliation': 'Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.).'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': 'Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.043467'] 1474,31555836,[Treatment adherence and effectiveness of anti-Vascular Endothelial Growth Faktor(VEGF) treatment of diabetic macular edema in the clinical routine : Comparison between cooperative and unicentric organization of treatment].,"BACKGROUND Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is an established method for treatment of diabetic macular edema (DME); however, to ensure the best possible functional results continuous treatment of patients over a long period with regular control visits are necessary. The adherence of patients to the treatment is of great importance for success. METHODS In order to make implementation of treatment easier for patients, an internet-based referral platform was established to enable the follow-up examination to be performed by an ophthalmologist using spectal domain optical coherence tomography (SD-OCT) close to the patients place of residence. Based on 50 patients the effectiveness of this cooperative treatment (IT-Cooperation) was compared to 50 patients who were controlled in the treatment center for DME patients over a period of 2 years. RESULTS Patients in the IT-Cooperation group received an average of 6.3 injections in the first year of follow-up compared to the lower number of 5.2 injections for patients attending the treatment center. During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center). Patients of the IT-Cooperation showed an average of 12.0 control visits in contrast to the average number of 9.6 visits (p < 0.01) for patients attending the treatment center in the first year of observation. This difference between the two groups was significant and was confirmed in the second year of follow-up with 8.3 visits in the IT-Cooperation group compared to 4.4 visits in the treatment center group (p < 0.01). CONCLUSION The greater number of follow-up examinations close to the patient's place of residence for the IT-Cooperation group significantly improved the quality of treatment adherence in DME patients; however, intensive exchange of information between the ophthalmologist performing the control examinations and the treatment center where the injections were carried out is mandatory.",2020,During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center).,"['50 patients who were controlled in the treatment center for DME patients over a period of 2\xa0years', 'diabetic macular edema', 'diabetic macular edema (DME']","['anti-vascular endothelial growth factor (VEGF', 'anti-Vascular Endothelial Growth Faktor(VEGF']",['quality of treatment adherence'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]",,0.0180065,During the second year the average number of injections decreased to 2.7 (IT-Cooperation) and 2.4 (treatment center).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Faatz', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland. henrik.faatz@augen-franziskus.de.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rothaus', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Westhues', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heimes-Bussmann', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Farecki', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ziegler', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gutfleisch', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Spital', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lommatzsch', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pauleikhoff', 'Affiliation': 'Augenzentrum am St.\xa0Franziskus-Hospital Münster, Hohenzollernring\xa074, 48145, Münster, Deutschland.'}]",Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft,['10.1007/s00347-019-00977-7'] 1475,29728861,Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial.,"Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability. Among the next steps is the definition of the patient profile that is most likely to benefit from testing. Here we present a reanalysis of data from the AB-GEN randomized clinical trial showing that clinical utility of pharmacogenetic testing can be markedly influenced by patient characteristics such as age, baseline severity and duration of current depressive episode.Trial registration ClinicalTrials.gov NCT02529462.",2019,Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability.,['psychiatric pharmacogenetics'],[],['efficacy and tolerability'],"[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]",[],[],,0.219815,Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability.,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Menchón', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Espadaler', 'Affiliation': 'AB-Biotics SA, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tuson', 'Affiliation': 'AB-Biotics SA, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Saiz-Ruiz', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bobes', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Álvarez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pérez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain. vperezsola@parcdesalutmar.cat.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-018-1879-z'] 1476,31479947,Quality of surgery and surgical reporting for patients with primary gastrointestinal stromal tumours participating in the EORTC STBSG 62024 adjuvant imatinib study.,"BACKGROUND EORTC (European Organisation of Research and Treatment of Cancer) 62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated. As surgical treatment aspects (tumour rupture and incomplete resection) contribute to the risk of recurrence, the data of primary surgery were reviewed. METHODS The surgical record, local pathology report and a surgical questionnaire on details of the operation had to be completed when patients entered the study. Surgeons from 5 countries, covering 8 languages, reviewed the full set of data being available from 793 patients (87.3%). RESULTS A known GIST was the reason for surgery in only 58% of the cases, and 12% of the patients were treated as an emergency. The R0-resection rate was 87%. The extent of resection was local excision in 17%, segmental resection in 59%, full-organ resection in 11% and multivisceral resection in 11%, with lymphadenectomy performed in 24% of the patients. Shelling out of the tumour was performed in 9.7%, and the proportion of tumours removed in parts was higher in the endoscopy/laparoscopy group. The incidence of tumour rupture (representing M1) was 9%. The consistency between preoperative and intraoperative findings was 82%. The postoperative complication rate was 7.3%. CONCLUSION The standardisation of surgery in this study was inferior. Given the review data, 18% of the patients should not have participated in the trial. Quality of surgery and improperly reported intraoperative details might influence the trial results. A detailed surgical questionnaire filled out by the surgeon is mandatory before entering the patient in an adjuvant trial in GIST.",2019,62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated.,"['Cancer', 'patients with primary gastrointestinal stromal tumours\xa0participating in the EORTC STBSG 62024 adjuvant imatinib study', 'patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated']",['adjuvant imatinib'],"['postoperative complication rate', 'full-organ resection', 'R0-resection rate', 'incidence of tumour rupture', 'Quality of surgery and surgical reporting']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2938957', 'cui_str': 'Tumour rupture'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",908.0,0.0413268,62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, University of Heidelberg, Germany. Electronic address: peter.hohenberger@umm.de.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgery, Department of Surgery, Institut Curie, PSL University, Paris, France.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Pjotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Center and Institute of Oncology, Roentgen Str 5, 02-781, Warsaw, Poland.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Stoeckle', 'Affiliation': ""Surgery Department, Institut Bergonie, 229 Cours de L'Argonne, 33000 Bordeaux, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Olungu', 'Affiliation': 'Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litiere', 'Affiliation': 'Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard-Domagk-Institute of Pathology, University of Münster Medical Center, Münster, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Casali', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.028'] 1477,31559966,"Long-term changes of gut microbiota, antibiotic resistance, and metabolic parameters after Helicobacter pylori eradication: a multicentre, open-label, randomised trial.","BACKGROUND In first-line treatment of Helicobacter pylori, we have previously shown that the eradication frequency was 83·7% (95% CI 80·4-86·6) for triple therapy for 14 days (T14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily), 85·9% (82·7-88·6) for concomitant therapy for 10 days (C10; lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily), and 90·4% (87·6-92·6) for bismuth quadruple therapy for 10 days (BQ10; bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day). In this follow-up study, we assess short-term and long-term effects of these therapies on the gut microbiota, antibiotic resistance, and metabolic parameters. METHODS This was a multicentre, open-label, randomised trial done at nine medical centres in Taiwan. Adult patients (>20 years) with documented H pylori infection were randomly assigned (1:1:1, with block sizes of six) to receive T14, C10, or BQ10. We assessed long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters) in patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status. Faecal samples were collected before treatment and 2 weeks, 2 months, and at least 1 year after eradication therapy. Amplification of the V3 and V4 hypervariable regions of the 16S rRNA was done followed by high-throughput sequencing. Susceptibility testing for faecal Escherichia coli and Klebsiella pneumoniae was done. This trial is complete and registered with ClinicalTrials.gov, NCT01906879. FINDINGS Between July 17, 2013, and April 20, 2016, 1620 participants were randomly assigned to the three treatment groups (540 [33%] per group). 1214 (75%) attended 1-year follow-up and are included in this analysis. Compared with baseline, alpha diversity was significantly reduced 2 weeks after T14 (p=0·0002), C10 (p<0·0001), and BQ10 (p<0·0001) treatment. Beta diversity was also significantly altered 2 weeks after T14 (p=0·0010), C10 (p=0·0001), and BQ10 (p=0·0001). Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029). A transient increase at week 2 after T14 and C10 of the resistance rates of E coli to ampicillin-sulbactam (12% [15/127] to 66% [38/58] for T14, 7% [10/135] to 64% [28/44] for C10), cefazolin (13% [16/127] to 43% [25/58] for T14, 10% [13/135] to 41% [18/44] for C10), cefmetazole (8% [10/127] to 26% [15/58] for T14, 4% [5/135] to 18% [8/44] for C10), levofloxacin (8% [10/127] to 35% [20/58] for T14, 7% [10/135] to 32% [14/44] for C10), gentamicin (13% [19/146] to 47% [27/58] for T14, 15% [22/149] to 45% [20/44] for C10), and trimethoprim-sulfamethoxazole (33% [48/146] to 86% [50/58] for T14, 28% [42/148] to 86% [38/44] for C10; p<0·05 in paired samples in the above analyses) returned to basal state at week 8 and after 1 year. Although bodyweight and body-mass index slightly increased, there were significant improvements in metabolic parameters, with a decrease in insulin resistance, triglycerides, and LDL and an increase in HDL. Overall, there was no significant change in the prevalence of metabolic syndrome at week 8 and 1 year after T14, C10, and BQ10. INTERPRETATION Eradication of H pylori infection has minimal disruption of the microbiota, no effect on antibiotic resistance of E coli, and some positive effects on metabolic parameters. Collectively, these results lend support to the long-term safety of H pylori eradication therapy. FUNDING National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.",2019,"Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029).","['Adult patients (>20 years) with documented H pylori infection', 'patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status', 'nine medical centres in Taiwan', '1620 participants', 'Helicobacter pylori', 'Between July 17, 2013, and April 20, 2016', 'National Taiwan University Hospital and Ministry of Science and Technology of Taiwan']","['lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole', 'cefazolin', 'levofloxacin', 'T14, C10, or BQ10', 'trimethoprim-sulfamethoxazole', 'clarithromycin', 'gentamicin', 'lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole', 'lansoprazole 30 mg, amoxicillin']","['alpha diversity', 'Alpha diversity and beta diversity', 'insulin resistance, triglycerides, and LDL and an increase in HDL', 'Beta diversity', 'gut microbiota, antibiotic resistance, and metabolic parameters', 'long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters', 'metabolic parameters', 'prevalence of metabolic syndrome', 'resistance rates of E coli to ampicillin-sulbactam', 'eradication frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1123624', 'cui_str': 'Tetracycline 500 MG'}, {'cui': 'C0585291', 'cui_str': 'Four times daily (qualifier value)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C2930041', 'cui_str': 'Ampicillin / Sulbactam'}]",1620.0,0.144441,"Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029).","[{'ForeName': 'Jyh-Ming', 'Initials': 'JM', 'LastName': 'Liou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Chieh-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Chang', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan; Mackay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'Po-Yueh', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan; Department of Internal Medicine Fu Jen Catholic University Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Yao-Chun', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan; Department of Internal Medicine Fu Jen Catholic University Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Mei-Jyh', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chien-Chuan', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ji-Yuh', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Tsung-Hua', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine and Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chi-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Yen-Nien', 'Initials': 'YN', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Jeng-Yih', 'Initials': 'JY', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jaw-Town', 'Initials': 'JT', 'LastName': 'Lin', 'Affiliation': 'Digestive Medicine Center, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Tzu-Pin', 'Initials': 'TP', 'LastName': 'Lu', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan; Institute of Epidemiology and Preventive Medicine, Department of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Eric Y', 'Initials': 'EY', 'LastName': 'Chuang', 'Affiliation': 'Bioinformatics and Biostatistics Core, Centers of Genomic and Precision Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Biomedical Electronics and Bioinformatics, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Emad M', 'Initials': 'EM', 'LastName': 'El-Omar', 'Affiliation': 'Microbiome Research Centre, St George & Sutherland Clinical School, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ming-Shiang', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: mingshiang@ntu.edu.tw.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30272-5'] 1478,31537473,"Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial.","BACKGROUND Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis. METHODS We did a randomised, controlled, phase 2-3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen-A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6-8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15. FINDINGS Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210-262) in the hyperbaric oxygen therapy group and 217 days (195-237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2-18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy. INTERPRETATION Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment. FUNDING The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.",2019,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy. ","['n=42) or standard care (n=45', 'group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group', 'All patients aged 18-80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion', '223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients', 'five Nordic university hospitals']","['hyperbaric oxygen therapy', 'hyperbaric oxygen therapy (30-40 sessions, 100% oxygen, breathed at a pressure of 240-250 kPa, for 80-90 min daily) or standard care with no restrictions for other medications or interventions', 'Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART', 'RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen', 'radiotherapy']","['symptoms of late radiation cystitis', 'Symptoms of late radiation cystitis', 'Expanded Prostate Index Composite Score (EPIC', 'Median time', 'transient grade 1-2 adverse events, related to sight and hearing', 'change in patient-perceived urinary symptoms assessed with EPIC', 'EPIC urinary total score', 'absolute change in EPIC urinary total score']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0436385', 'cui_str': 'Radiotherapy completed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439474', 'cui_str': 'kPa'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0156270', 'cui_str': 'Irradiation cystitis (disorder)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",79.0,0.156227,"17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1-2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy. ","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Oscarsson', 'Affiliation': 'Angereds Närsjukhus, Angered, Sweden; Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden. Electronic address: nicklas.oscarsson@vgregion.se.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Rosén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pär', 'Initials': 'P', 'LastName': 'Lodding', 'Affiliation': 'Department of Urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mölne', 'Affiliation': 'Department of Pathology and Genetics, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giglio', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Hjelle', 'Affiliation': 'Department of Urology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Vaagbø', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hyldegaard', 'Affiliation': 'Department of Anaesthesia and Surgery, Hyperbaric Unit, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vangedal', 'Affiliation': 'Department of Urology, Herlev-Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Salling', 'Affiliation': 'Department of Urology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kjellberg', 'Affiliation': 'Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Lind', 'Affiliation': 'Department of Physiology and Pharmacology, Section for Anaesthesiology and Intensive Care Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Ettala', 'Affiliation': 'Department of Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Arola', 'Affiliation': 'Department of Anaesthesiology and Intensive, University of Turku, Turku, Finland.'}, {'ForeName': 'Helén', 'Initials': 'H', 'LastName': 'Seeman-Lodding', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30494-2'] 1479,32100679,"Improving Complementary Food Hygiene Behaviors Using the Risk, Attitude, Norms, Ability, and Self-Regulation Approach in Rural Malawi.","The study evaluated the effectiveness of an intervention to improve complementary food hygiene behaviors among child caregivers in rural Malawi. Formative research and intervention development was grounded in the risk, attitude, norms, ability, and self-regulation (RANAS) model and targeted washing hands and kitchen utensils with soap, safe utensil storage, reheating of leftover food, and feeding of children by caregivers. Longitudinal research was applied at baseline and follow-up surveys among 320 caregivers. Determinants of selected behaviors were found, and interventions were developed based on the behavior change techniques aligned with these determinants in the RANAS model. The intervention was delivered over 9 months through group (cluster) meetings and household visits and included demonstrations, games, rewards, and songs. We randomly assigned villages to the control or intervention group. Follow-up results indicated a significant increase in three targeted behaviors (washing kitchen utensils with soap, safe utensil storage, and handwashing with soap) among intervention recipients. Several psychosocial factors differed significantly between the intervention and control groups. Mediation results showed that the intervention had a significant effect on these three targeted behaviors. For handwashing, feelings, others' behavior in the household, and remembering; for washing kitchen utensils, others' behavior in the household and difficulty to get enough soap; for safe utensils storage, others' behavior in the village and remembering mediated the effect of the intervention on the targeted behaviors. The study demonstrated that targeting food hygiene behaviors with a theory-driven behavior change approach using psychosocial factors can improve the behavior of child caregivers in rural Malawi.",2020,Several psychosocial factors differed significantly between the intervention and control groups.,"['Rural Malawi', 'child caregivers in rural Malawi', '320 caregivers']",[],['Several psychosocial factors'],"[{'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}]",[],"[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",,0.0199568,Several psychosocial factors differed significantly between the intervention and control groups.,"[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Jurgita', 'Initials': 'J', 'LastName': 'Slekiene', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0528'] 1480,31499383,Impact of dose and duration of therapy on dexamethasone pharmacokinetics in childhood acute lymphoblastic leukaemia-a report from the UKALL 2011 trial.,"INTRODUCTION The use of dexamethasone in acute lymphoblastic leukaemia therapy contributes to short- and long-term toxicities. The UKALL 2011 randomised trial investigated whether a more intense dexamethasone dose (10 mg/m 2 /d x 14d, short vs 6 mg/m 2 /d x 28d, standard) would lead to a more rapid cytoreduction and reduced adverse effects associated with longer durations of steroids in induction. The impact of dose and duration on dexamethasone pharmacokinetics was investigated. METHODS Blood samples were obtained on one of the first three and last three days of induction dexamethasone dosing at time points up to 8 h after oral administration. Plasma dexamethasone levels were quantified in 1084 plasma samples obtained from 174 children and a population pharmacokinetic model developed. RESULTS Drug exposure varied significantly between patients, with a >12-fold variation in AUC 0-12h values and a marked overlap in dexamethasone exposures between dose levels. Intuitively, AUC 0-12h was significantly higher with short dosing (10 mg/m 2 /d), but cumulative exposure was significantly higher with standard dosing over 28 days, after a higher cumulative dose. Concomitant rasburicase administration was associated with a 60% higher dexamethasone clearance. Day 8 bone marrow response was comparable between dosing arms, but those with <5% blast count exhibited a greater mean dexamethasone exposure than those with >5%. No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction. CONCLUSION The potential significance of dexamethasone AUC 0-12h on early response and higher cumulative exposure on the standard arm suggest that duration of therapy and exposure may be more important factors than absolute dose from a clinical pharmacology perspective.",2019,"No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction. ",['childhood acute lymphoblastic leukaemia'],"['dexamethasone pharmacokinetics', 'dexamethasone', 'dexamethasone AUC', 'induction dexamethasone']","['dexamethasone clearance', 'cumulative exposure', 'bone marrow response', 'Plasma dexamethasone levels']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",2011.0,0.0731507,"No statistical differences were observed between arms in terms of steroid-related toxicity or minimal residual disease at the end of induction. ","[{'ForeName': 'Rosanna K', 'Initials': 'RK', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Liebich', 'Affiliation': 'Department of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, University of Münster, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Berry', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Errington', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jizhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Moppett', 'Affiliation': 'Department of Paediatric Haematology and Oncology, Bristol Royal Hospital for Children, UK.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Samarasinghe', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hough', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Rowntree', 'Affiliation': 'University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Goulden', 'Affiliation': 'Department of Haematology, Great Ormond Street Hospital for Children, London, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Vora', 'Affiliation': 'Department of Paediatric Haematology, Great Ormond Street Hospital, UK.'}, {'ForeName': 'Pamela R', 'Initials': 'PR', 'LastName': 'Kearns', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Institute of Cancer and Genomic Studies, University of Birmingham, UK.'}, {'ForeName': 'Vaskar', 'Initials': 'V', 'LastName': 'Saha', 'Affiliation': 'Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK; Tata Translational Cancer Research Centre, Tata Medical Center, Kolkata, India.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Department of Pharmaceutical and Medical Chemistry, Clinical Pharmacy, University of Münster, Germany.'}, {'ForeName': 'Julie A E', 'Initials': 'JAE', 'LastName': 'Irving', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Veal', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle Upon Tyne, UK. Electronic address: G.J.Veal@ncl.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.026'] 1481,31482852,User Experience of 7 Mobile Electroencephalography Devices: Comparative Study.,"BACKGROUND Registration of brain activity has become increasingly popular and offers a way to identify the mental state of the user, prevent inappropriate workload, and control other devices by means of brain-computer interfaces. However, electroencephalography (EEG) is often related to user acceptance issues regarding the measuring technique. Meanwhile, emerging mobile EEG technology offers the possibility of gel-free signal acquisition and wireless signal transmission. Nonetheless, user experience research about the new devices is lacking. OBJECTIVE This study aimed to evaluate user experience aspects of emerging mobile EEG devices and, in particular, to investigate wearing comfort and issues related to emotional design. METHODS We considered 7 mobile EEG devices and compared them for their wearing comfort, type of electrodes, visual appearance, and subjects' preference for daily use. A total of 24 subjects participated in our study and tested every device independently of the others. The devices were selected in a randomized order and worn on consecutive day sessions of 60-min duration. At the end of each session, subjects rated the devices by means of questionnaires. RESULTS Results indicated a highly significant change in maximal possible wearing duration among the EEG devices (χ 2 6 =40.2, n=24; P<.001). Regarding the visual perception of devices' headset design, results indicated a significant change in the subjects' ratings (χ 2 6 =78.7, n=24; P<.001). Results of the subjects' ratings regarding the practicability of the devices indicated highly significant differences among the EEG devices (χ 2 6 =83.2, n=24; P<.001). Ranking order and posthoc tests offered more insight and indicated that pin electrodes had the lowest wearing comfort, in particular, when coupled with a rigid, heavy headset. Finally, multiple linear regression for each device separately revealed that users were not willing to accept less comfort for a more attractive headset design. CONCLUSIONS The study offers a differentiated look at emerging mobile and gel-free EEG technology and the relation between user experience aspects and device preference. Our research could be seen as a precondition for the development of usable applications with wearables and contributes to consumer health informatics and health-enabling technologies. Furthermore, our results provided guidance for the technological development direction of new EEG devices related to the aspects of emotional design.",2019,"Ranking order and posthoc tests offered more insight and indicated that pin electrodes had the lowest wearing comfort, in particular, when coupled with a rigid, heavy headset.",['24 subjects participated in our study and tested every device independently of the others'],['electroencephalography (EEG'],['maximal possible wearing duration'],"[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1720374', 'cui_str': 'Every'}, {'cui': 'C0205394', 'cui_str': 'Other (qualifier value)'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",24.0,0.0422883,"Ranking order and posthoc tests offered more insight and indicated that pin electrodes had the lowest wearing comfort, in particular, when coupled with a rigid, heavy headset.","[{'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Radüntz', 'Affiliation': 'Mental Health and Cognitive Capacity, Federal Institute for Occupational Safety and Health, Berlin, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Meffert', 'Affiliation': 'Department of Computer Science, Humboldt-Universität zu Berlin, Berlin, Germany.'}]",JMIR mHealth and uHealth,['10.2196/14474'] 1482,31559948,Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT.,"BACKGROUND Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients. PRIMARY OBJECTIVE Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM). DESIGN A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element). SETTING The trial was set in 42 secondary and community inpatient facilities in the UK. PARTICIPANTS Adult inpatients with evidence of acute illness and at a high risk of PU development. INTERVENTIONS AND FOLLOW-UP APM or HSFM - the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up. MAIN OUTCOME MEASURES Time to event. RESULTS From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( n  = 1016) or HSFM ( n  = 1013). Primary end point - 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact p -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93; p  = 0.0176 and 2.6% absolute difference). Secondary end points - 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; p -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62; p  = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed - there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68; p  = 0.6122 and absolute difference 2.9%). Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy - the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was 'very good' (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy - the Pressure Ulcer Quality of Life - Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness. LIMITATIONS A lower than anticipated event rate. CONCLUSIONS In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU. FUTURE WORK Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore 'what works for whom and in what circumstances'. TRIAL REGISTRATION Current Controlled Trials ISRCTN01151335. FUNDING This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.",2019,"Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small.","['2954 participants', 'at-risk patients', 'high-risk patients', '42 secondary and community inpatient facilities in the UK', 'acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain', 'Adult inpatients with evidence of acute illness and at a high risk of PU development', '2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥\u20092', 'From August 2013 to November 2016, 2029 participants']","['APM', 'HSFM', 'high-specification foam mattress (HSFM', 'alternating pressure mattress (APM']","['time to PU development', 'time to healing', ' 30-day final follow-up: new PUs of category ≥\u20091 developed', 'Time to event', 'treatment phase time-to-event sensitivity analysis', 'pressure ulcers', 'mental capacity, levels of independent movement, repositioning and PU development']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]",2954.0,0.208005,"Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Isabelle L', 'Initials': 'IL', 'LastName': 'Smith', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McGinnis', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'E Andrea', 'Initials': 'EA', 'LastName': 'Nelson', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Collier', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gilberts', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Henderson', 'Affiliation': 'Independent Tissue Viability Consultant, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Muir', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rutherford', 'Affiliation': 'Quality of Life Office, Psycho-oncology Co-operative Research Group, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Stubbs', 'Affiliation': 'Neighbourhood Team North 1, Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thorpe', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Wallner', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Pressure Ulcer Research Service User Network, Leeds, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23520'] 1483,31843839,Door-to-needle time for thrombolysis: a secondary analysis of the TIPS cluster randomised controlled trial.,"OBJECTIVE The current study aimed to evaluate the effects of a multi-component in-hospital intervention on the door-to-needle time for intravenous thrombolysis in acute ischaemic stroke. DESIGN This study was a post hoc analysis of door-to-needle time data from a cluster-randomised controlled trial testing an intervention to boost intravenous thrombolysis implementation. SETTING The study was conducted among 20 hospitals from three Australian states. PARTICIPANT Eligible hospitals had a Stroke Care Unit or staffing equivalent to a stroke physician and a nurse, and were in the early stages of implementing thrombolysis. INTERVENTION The intervention was multifaceted and developed using the behaviour change wheel and informed by breakthrough collaborative methodology using components of the health behaviour change wheel. PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcome for this analysis was door-to-needle time for thrombolysis and secondary outcome was the proportion of patients received thrombolysis within 60 min of hospital arrival. RESULTS The intervention versus control difference in the door-to-needle times was non-significant overall nor significant by hospital classification. To provide additional context for the findings, we also evaluated the results within intervention and control hospitals. During the active-intervention period, the intervention hospitals showed a significant decrease in the door-to-needle time of 9.25 min (95% CI: -16.93 to 1.57), but during the post-intervention period, the result was not significant. During the active intervention period, control hospitals also showed a significant decrease in the door-to-needle time of 5.26 min (95% CI: -8.37 to -2.14) and during the post-intervention period, this trend continued with a decrease of 12.13 min (95% CI: -17.44 to 6.81). CONCLUSION Across these primary stroke care centres in Australia, a secular trend towards shorter door-to-needle times across both intervention and control hospitals was evident, however the TIPS (Thrombolysis ImPlementation in Stroke) intervention showed no overall effect on door-to-needle times in the randomised comparison. TRIAL REGISTRATION NUMBER Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN 12613000939796.",2019,The intervention versus control difference in the door-to-needle times was non-significant overall nor significant by hospital classification.,"['20 hospitals from three Australian states', 'Eligible hospitals had a Stroke Care Unit or staffing equivalent to a stroke physician and a nurse, and were in the early stages of implementing thrombolysis']",['multi-component in-hospital intervention'],"['proportion of patients received thrombolysis within 60\u2009min of hospital arrival', 'door-to-needle time', 'door-to-needle time for thrombolysis']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1278452', 'cui_str': 'Door to needle time'}]",,0.0908892,The intervention versus control difference in the door-to-needle times was non-significant overall nor significant by hospital classification.,"[{'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Hasnain', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia mdgolam.hasnain@uon.edu.au.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Attia', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kerr', 'Affiliation': 'John Hunter Hospital, Department of Neurology, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Clinical Research Design and Statistical Services, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Abul Hasnat', 'Initials': 'AH', 'LastName': 'Milton', 'Affiliation': 'Epidemiology Resource Centre, Dhaka, Dhaka, Bangladesh.'}, {'ForeName': 'Isobel J', 'Initials': 'IJ', 'LastName': 'Hubbard', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'School of Medicine and Public Health (SMPH), Faculty of Health and Medicine, University of Newcastle (UoN), Callaghan, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032482'] 1484,27016006,Oxytocin blurs the self-other distinction during trait judgments and reduces medial prefrontal cortex responses.,"The neuropeptide oxytocin (OXT) may act either to increase or blur the distinction between self and other and thereby promote either more selfish or altruistic behaviors. To attempt to distinguish between these two possibilities we performed a double-blind, between-subject, placebo-controlled design study to investigate the effect of intranasal OXT on self and other (mother, classmate, or stranger) trait judgments in conjunction with functional magnetic resonance imaging. Results showed that OXT reduced response times for making both self and other judgments, but also reduced the accuracy of their subsequent recall, thereby abolishing the normal self-bias observed in this task. OXT also abolished the positive correlation between response and self-esteem scale scores seen in the PLC group, suggesting that its effects were strongest in individuals with higher levels of self-esteem. A whole-brain functional magnetic resonance imaging analysis revealed that OXT also reduced responses during both self and other trait judgments in the dorsal (dmPFC) and ventral (vmPFC) medial prefrontal cortex. A subsequent region of interest analysis revealed that behavioral performance and self-esteem scale scores were associated with dmPFC activation and its functional connectivity with the anterior cingulate and between the vmPFC and posterior cingulate. Thus overall, while OXT may improve speed of decision making in self -vs. other trait judgments it also blunts the normal bias towards remembering self-attributes and reduces mPFC responses and connectivity with other cortical midline regions involved in self-processing. This is consistent with the view that OXT can reduce self-centered behavior. Hum Brain Mapp 37:2512-2527, 2016. © 2016 Wiley Periodicals, Inc.",2016,A whole-brain functional magnetic resonance imaging analysis revealed that OXT also reduced responses during both self and other trait judgments in the dorsal (dmPFC) and ventral (vmPFC) medial prefrontal cortex.,['2016'],"['placebo', 'neuropeptide oxytocin (OXT', 'functional magnetic resonance imaging', 'Oxytocin', 'intranasal OXT', 'OXT']","['behavioral performance and self-esteem scale scores', 'medial prefrontal cortex responses', 'response and self-esteem scale scores', 'accuracy of their subsequent recall, thereby abolishing the normal self-bias']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",,0.0361429,A whole-brain functional magnetic resonance imaging analysis revealed that OXT also reduced responses during both self and other trait judgments in the dorsal (dmPFC) and ventral (vmPFC) medial prefrontal cortex.,"[{'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Yayuan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Xiaole', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': ""Key Laboratory for Neuroinformation, School of Life Science and Technology, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, People's Republic of China.""}]",Human brain mapping,['10.1002/hbm.23190'] 1485,32418680,The effect of nutritional education program on quality of life and serum electrolytes levels in hemodialysis patients: A single-blind randomized controlled trial.,"OBJECTIVE To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels. METHODS This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared. RESULTS There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16). CONCLUSION The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients. PRACTICE IMPLICATIONS This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods.",2020,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"['94 eligible hemodialysis patients', 'hemodialysis patients']","['nutritional education program', 'nutrition education program']","['QoL scores and electrolytes', 'quality of life and serum electrolytes levels', 'levels of Na, K, P and Mg', ""hemodialysis patients' quality of life (QoL) and serum electrolytes levels"", 'Calcium level', 'QoL and serum electrolytes', 'Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels', 'QoL scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C1287347', 'cui_str': 'Serum electrolyte levels - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",94.0,0.0310619,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naseri-Salahshour', 'Affiliation': 'School of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran. Electronic address: vahidnaseri1994@yahoo.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Sajadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Basij Sq., Sardasht Region, 6941738481 Arak, Iran. Electronic address: sajadimahbobeh@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nikbakht-Nasrabadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: nikbakht@tums.ac.ir.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Basij Sq., Sardasht Region, 6941738481 Iran. Electronic address: fahimedavodabady@gmail.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'College of Doctoral Studies, Grand Canyon University, Phoenix, AZ, USA. Electronic address: afournier2@my.gcu.edu.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.021'] 1486,31047734,Re: Evaluation of Intense Androgen Deprivation Before Prostatectomy: A Randomized Phase II Trial of Enzalutamide and Leuprolide With or Without Abiraterone.,,2019,,['Intense Androgen Deprivation Before Prostatectomy'],['Enzalutamide and Leuprolide With or Without Abiraterone'],[],"[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]",[],,0.0205836,,"[{'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Devos', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium. Electronic address: gaetan.devos@uzleuven.be.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'De Meerleer', 'Affiliation': 'Department of Radiotherapy, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Charlien', 'Initials': 'C', 'LastName': 'Berghen', 'Affiliation': 'Department of Radiotherapy, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Joniau', 'Affiliation': 'Department of Urology, University Hospitals Leuven, Leuven, Belgium.'}]",European urology,['10.1016/j.eururo.2019.04.023'] 1487,31272834,"Effects of Mokuboito, a Japanese Kampo medicine, on symptoms in patients hospitalized for acute decompensated heart failure - A prospective randomized pilot study.","BACKGROUND Although standard treatment for heart failure (HF) has been established, it remains difficult to relieve HF-associated symptoms in some patients. Kampo medicines have been used to treat various diseases; however, it remains unclear whether they are effective in HF patients. We therefore performed a prospective, randomized, controlled trial to investigate whether Mokuboito, a Kampo medicine, affected symptoms and other parameters in hospitalized patients with acute decompensated HF (ADHF), as compared to standard therapy alone. METHODS Forty patients were allocated randomly to Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy). The primary outcome was changes in global clinical status based on a visual analog scale (VAS) from baseline at day 10 or discharge if earlier. RESULTS The decrease in VAS score was significantly greater in Group M than Group S (p=0.001). Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload. CONCLUSIONS Oral administration of Mokuboito significantly improved ADHF-related symptoms. Our observations might provide the basis for a novel therapeutic strategy in hospitalized patients with ADHF.",2019,"Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload. ","['hospitalized patients with acute decompensated HF (ADHF', 'heart failure (HF', 'patients hospitalized for acute decompensated heart failure ', 'Forty patients', 'hospitalized patients with ADHF']","['Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy', 'Mokuboito, a Japanese Kampo medicine']","['ADHF-related symptoms', 'VAS score', 'body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels', 'global clinical status based on a visual analog scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}]","[{'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0001563', 'cui_str': 'Drug Administration, Oral'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0752221', 'cui_str': 'Kanpo'}]","[{'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0541978,"Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload. ","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Ezaki', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan. Electronic address: hirotakaezaki@gmail.com.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayaori', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Oita Oka Hospital, Oita, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Maeno', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Miyake', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Tokorozawa, Saitama, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.05.003'] 1488,31843845,"Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting.","INTRODUCTION BCG vaccination reduces all-cause infant mortality in high-mortality settings by more than can be attributed to protection against tuberculosis. This is proposed to result from non-specific protection against non-vaccine targeted ('off-target') infections. There is also evidence that BCG protects against allergic diseases. METHODS AND ANALYSIS The Melbourne Infant Study: BCG for Allergy and Infection Reduction is a phase III multicentre, single-blinded, randomised controlled trial. A total of 1438 healthy neonates will be randomised to receive either BCG vaccination or no BCG vaccination in the first 10 days of life. Measures of allergy, eczema, infection and asthma will be obtained from parent-completed questionnaires 3 monthly in the first year and 6 monthly from 1 to 5 years of age, and clinical assessments at 1 and 5 years of age. Biological samples will also be collected for future immunological studies. ANALYSIS PRIMARY OUTCOME The proportion of participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5 years of age, and asthma at 5 years of age. SECONDARY OUTCOMES (1) the proportion of participants with additional measures of allergy, eczema, asthma and infections; (2) medication use for eczema and asthma; (3) the severity and age of onset of eczema and asthma; (4) the number of episodes of infection; (5) hospitalisations for infections and (6) laboratory measures of immune responses. ETHICS AND DISSEMINATION This trial has ethical and governance approval from Mercy Health Human Research Ethics Committee (HREC, No. R12-28) and Royal Children's Hospital HREC (No. 33025) with additional governance approval from Barwon Health and St John of God, Geelong, Victoria. Results of this trial will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER NCT01906853.",2019,"The proportion of participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5 years of age, and asthma at 5 years of age. ","[""Royal Children's Hospital HREC (No. 33025) with additional governance approval from Barwon Health and St John of God, Geelong, Victoria"", 'participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5\u2009years of age, and asthma at 5\u2009years of age', '1438 healthy neonates']","['BCG', 'BCG vaccination or no BCG vaccination', 'neonatal BCG vaccination']","['allergy, eczema, infection and asthma', 'proportion of participants with additional measures of allergy, eczema, asthma and infections; (2) medication use for eczema and asthma; (3) the severity and age of onset of eczema and asthma; (4) the number of episodes of infection; (5) hospitalisations for infections and (6) laboratory measures of immune responses']","[{'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",1438.0,0.166004,"The proportion of participants with measures of allergy and infection (atopic sensitisation, eczema, lower respiratory tract infection) at 1 and 5 years of age, and asthma at 5 years of age. ","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kaya', 'Initials': 'K', 'LastName': 'Gardiner', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': 'Department of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Flanagan', 'Affiliation': 'School of Health Sciences, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Anne-Louise', 'Initials': 'AL', 'LastName': 'Ponsonby', 'Affiliation': 'Department of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Shann', 'Affiliation': 'Department of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Robins-Browne', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Freyne', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Abruzzo', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Morison', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Lianne', 'Initials': 'L', 'LastName': 'Cox', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Germano', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Zufferey', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Allen', 'Affiliation': ""Formerly of Centre for Food and Allergy Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuillermin', 'Affiliation': 'School of Medicine, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'South', 'Affiliation': 'Department of Paediatrics, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Casalaz', 'Affiliation': 'Neonatal Intensive Care Unit, Mercy Hospital for Women, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Infectious Diseases, Murdoch Children's Research Institute, Parkville, Victoria, Australia nigel.curtis@rch.org.au.""}]",BMJ open,['10.1136/bmjopen-2019-032844'] 1489,31499384,The clinical role of VeriStrat testing in patients with advanced non-small cell lung cancer considered unfit for first-line platinum-based chemotherapy.,"PURPOSE We previously demonstrated that the median survival of patients with poor prognosis non-small cell lung cancer (NSCLC) considered unfit for first-line platinum chemotherapy was <4 months. We evaluated whether VeriStrat could be used as a prognostic or predictive biomarker in this population. EXPERIMENTAL DESIGN We conducted a randomised double-blind trial among patients with untreated advanced NSCLC considered unfit for platinum chemotherapy because of poor performance status (PS) or multiple comorbidities. All patients received active supportive care (ASC) and were treated with either oral erlotinib or placebo daily. Five hundred twenty-seven patients had plasma samples for VeriStrat classification: good (VeriStrat Good [VSG]) or poor (VeriStrat Poor [VSP]). Main end-point was overall survival. RESULTS Fifty-five percent patients had VSG, and 83% had Eastern Cooperative Oncology Group (ECOG) 2-3 at baseline. VeriStrat was strongly associated with survival. Among patients managed with ASC only, the adjusted hazard ratio (HR) was 0.54 (p < 0.001) for VSG versus VSP. The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 < 0.001) for age≥75 years and HR = 0.59 (p = 0.007) for stage IV. Several ECOG 2-3 patients had long survival: 2-year survival was 8% for VSG patients who had ASC, compared with 0% for VSP. VeriStrat status did not predict benefit from erlotinib treatment because the HRs for erlotinib versus placebo were similar between VSG and VSP patients. CONCLUSIONS VeriStrat was not a predictive marker for survival when considering first-line erlotinib for patients with NSCLC who had poor PS and were not recommended for platinum doublet therapies. However, VeriStrat was an independent prognostic marker of survival. It represents an objective measurement that could be considered alongside other patient factors to provide a more refined assessment of prognosis for this particular patient group. VSG patients could be selected for treatment trials because of better survival, while VSP patients can continue to be treated conservatively or offered trials of less toxic agents. TRIAL REGISTRATION ISRCTN NUMBER ISRCTN02370070.",2019,"The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 ","['patients with advanced non-small cell lung cancer considered unfit for first-line platinum-based chemotherapy', 'Five hundred twenty-seven patients had plasma samples for VeriStrat classification: good (VeriStrat Good [VSG]) or poor (VeriStrat Poor [VSP', 'VSG patients', 'patients with untreated advanced NSCLC considered unfit for platinum chemotherapy because of poor performance status (PS) or multiple comorbidities', 'Fifty-five percent patients had VSG, and 83% had Eastern Cooperative Oncology Group (ECOG', 'patients with NSCLC who had poor PS']","['placebo', 'oral erlotinib or placebo', 'active supportive care (ASC']","['median survival', 'long survival', 'survival', 'overall survival', '2-year survival', 'adjusted hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",527.0,0.359436,"The association was consistent across patient factors: HR = 0.25 (p = 0.004) and HR = 0.56 (p < 0.001) for ECOG 0-1 and 2-3, respectively, HR = 0.49 (0070 ","[{'ForeName': 'Siow Ming', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'University College London Hospitals, London, UK; London Lung Cancer Group, London, UK; Cancer Research UK Lung Cancer Centre of Excellence, UCL, London, UK. Electronic address: sm.lee@nhs.net.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Upadhyay', 'Affiliation': 'Castle Hill Hospital, Hull, UK.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Lewanski', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Skailes', 'Affiliation': 'Lancashire Teaching Hospitals, Lancashire, UK.'}, {'ForeName': 'Penella J', 'Initials': 'PJ', 'LastName': 'Woll', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hatton', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Lal', 'Affiliation': ""Guys and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Toy', 'Affiliation': 'Royal Devon and Exeter Foundation NHS Trust, Exeter, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Rudd', 'Affiliation': 'London Lung Cancer Group, London, UK.'}, {'ForeName': 'Yenting', 'Initials': 'Y', 'LastName': 'Ngai', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'DataNova Ltd, London, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'Cancer Research UK & UCL Cancer Trials Centre, UCL, London, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.025'] 1490,32416635,The efficacy and safety of fractional radiofrequency nanoneedle system in the treatment of atrophic acne scars in Asians.,"BACKGROUND Multiple treatment modalities have been developed to treat atrophic acne scars with varying degrees of success. Post-inflammatory hyperpigmentation (PIH) after acne scar treatments remain a major concern in Asian patients. Fractional radiofrequency (FRF) has been used in many dermatological skin conditions including acne scars. AIMS To determine the efficacy and safety of FRF nanoneedle system in the treatment of acne scars in Asians. METHODS This is a prospective, evaluator-blinded study with 25 subjects diagnosed with moderate to severe acne scarring. All subjects received 3 monthly treatments of the FRF nanoneedle system on both cheeks. Primary outcome was the clinical improvement of acne scars graded by 2 blinded dermatologists at baseline, 1-, 3-, and 6-month follow-ups. Objective scar volume analysis was done using ultraviolet A (UVA) light video camera. Subjects' self-assessment, pain score, and adverse events were also recorded. RESULTS Twenty-three out of 25 subjects completed the study and attended all follow-up. Clinical improvement of acne scars was observed as early as 1-month follow-up. Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (P < .005). Majority of the subjects (48%) reported marked improvement in their acne scars. Adverse events such as pain, erythema, burning sensation, edema, scab formation, and PIH were mild and temporary. CONCLUSIONS FRF nanoneedle system is a safe and effective treatment for acne scars in Asians. However, despite the significant changes in the scar volume, caution should be used to avoid excessive coagulation resulting in PIH.",2020,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"['Asian patients', 'acne scars in Asians', '25 subjects diagnosed with moderate to severe acne scarring', 'Twenty-three out of 25 subjects completed the study and attended all follow-up', 'atrophic acne scars in Asians']","['ultraviolet A (UVA) light video camera', 'FRF nanoneedle system', 'fractional radiofrequency nanoneedle system', 'Fractional radiofrequency (FRF']","['clinical improvement of acne scars graded by 2 blinded dermatologists', 'acne scars', 'acne scar volume', ""Subjects' self-assessment, pain score and adverse events"", 'Adverse events such as pain, erythema, burning sensation, edema, scab formation and PIH were mild and temporary', 'efficacy and safety']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0074125', 'cui_str': 'SCAB protocol'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.0167839,Objective evaluation of acne scar volume decreased significantly on all follow-up compared to baseline (p<0.005).,"[{'ForeName': 'Sunatra', 'Initials': 'S', 'LastName': 'Nitayavardhana', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13484'] 1491,31420292,Intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis: a cost-effectiveness analysis.,"BACKGROUND Outpatient parenteral antibiotic therapy after hospital admission is increasingly popular, but its use to avoid admission to hospital altogether by treating patients wholly as outpatients remains uncommon in children. One reason for the low use of treatment at home is the scarcity of evidence of its cost-effectiveness. In this planned follow-up analysis of the Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial, we aimed to assess the cost-effectiveness of an admission avoidance pathway, in which children were treated at home, compared with standard hospital care for the intravenous treatment of moderate or severe cellulitis. METHODS We did a cost-effectiveness analysis to compare home treatment with intravenous ceftriaxone versus hospital treatment with intravenous flucloxacillin in children aged 6 months to 18 years who had presented to the emergency department at The Royal Children's Hospital, Melbourne, VIC, Australia, with moderate or severe uncomplicated cellulitis. We included costs from two sources: institutional costs at a patient level and expenses incurred by families. We measured effectiveness with quality-adjusted life years (QALYs), which we derived from the Child Health Utility 9D questionnaire, and a clinical outcome of treatment failure, which was the primary outcome of the CHOICE trial. We planned to calculate the incremental cost-effectiveness ratio, defined as the difference between groups in total cost divided by the difference between groups in effectiveness. The CHOICE trial is registered at ClinicalTrials.gov, number NCT02334124. FINDINGS We included 180 children who comprised the per-protocol population in the CHOICE trial: 89 children in the home group and 91 children in the hospital group. The institutional cost per patient per episode was significantly lower in the home group than in the hospital group (AUS$1965 vs $3775; p<0·0001). The mean cost incurred per family was $182 for the home group and $593 for the hospital group (p<0·0001). Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029). Calculating the incremental cost-effectiveness ratio was thus deemed redundant. INTERPRETATION Treatment at home was less costly and more effective than standard hospital care for children with moderate or severe cellulitis. These findings support development of this admission avoidance pathway in hospitals. FUNDING The Royal Children's Hospital Foundation, Murdoch Children's Research Institute.",2019,"Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029).","[""children aged 6 months to 18 years who had presented to the emergency department at The Royal Children's Hospital, Melbourne, VIC, Australia, with moderate or severe uncomplicated cellulitis"", 'children with moderate or severe cellulitis', 'children with cellulitis', '180 children who comprised the per-protocol population in the CHOICE trial: 89 children in the home group and 91 children in the hospital group']","['intravenous flucloxacillin', 'Intravenous ceftriaxone', 'ceftriaxone', 'flucloxacillin']","['treatment failure', 'institutional cost per patient per episode', 'mean cost incurred per family', 'effectiveness with quality-adjusted life years (QALYs', 'incremental cost-effectiveness ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016267', 'cui_str': 'flucloxacillin'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0162643'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282620', 'cui_str': 'Adjusted Life Years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",180.0,0.127728,"Both measures of effectiveness were significantly better in the home group than in the hospital group: QALYs were 0·005 for the home group versus 0·004 for the hospital group (p<0·0001), and treatment failure occurred in one (1%) patient in the home group versus seven (8%) patients in the hospital group (risk difference -6·5%, 95% CI -12·4 to -0·7; p=0·029).","[{'ForeName': 'Laila F', 'Initials': 'LF', 'LastName': 'Ibrahim', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Centre for Health Policy, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Hopper', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dalziel', 'Affiliation': 'Centre for Health Policy, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Emergency Department, The Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Bryant', 'Affiliation': ""Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Melbourne, VIC, Australia; Hospital-In-The-Home Department, The Royal Children's Hospital, Melbourne, VIC, Australia. Electronic address: penelope.bryant@rch.org.au.""}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30288-9'] 1492,31813450,Metronomic Maintenance Therapy for Rhabdomyosarcoma.,"In a recent article, Bisogno et al. reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival. Although the mechanism of action remains to be fully elucidated, this study paves the way for further evaluation of MMT as a potential therapeutic strategy in pediatric patients with high-risk disease.",2019,reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival.,"['children with rhabdomyosarcoma', 'Rhabdomyosarcoma', 'pediatric patients with high-risk disease']","['metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide', 'Metronomic Maintenance Therapy']",['overall and event-free survival'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.0369751,reported in a randomized trial that addition of metronomic maintenance therapy (MMT) with vinorelbine plus cyclophosphamide for children with rhabdomyosarcoma resulted in a significant increase in overall and event-free survival.,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'André', 'Affiliation': ""Pediatric Hematology and Oncology Department, Hôpital pour Enfant de La Timone, Assistance Publique - Hôpitaux de Marseille (AP-HM), Marseille, France; SMARTc unit, Centre de Recherche en Cancérologie de Marseille, Institut National de la Santé et de la Recherche Médicale (INSERM) Unité 1068, Université d'Aix-Marseille, Marseille, France; Metronomics Global Health Initiative, Marseille, France. Electronic address: nicolas.andre@ap-hm.fr.""}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': ""Institut d'Hématologie et Oncologie Pédiatrique, Lyon, France.""}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Shaked', 'Affiliation': 'Metronomics Global Health Initiative, Marseille, France; Faculty of Medicine, Cell Biology, and Cancer Science, Technion-Integrated Cancer Center, Technion, Israel Institute of Technology, Haifa, Israel.'}]",Trends in cancer,['10.1016/j.trecan.2019.10.004'] 1493,31474458,"Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial.","BACKGROUND Pathogen resistance and safety concerns limit oral antibiotic options for the treatment of acute bacterial skin and skin structure infections (ABSSSI). We aimed to compare the efficacy and safety of once-daily oral omadacycline, an aminomethylcycline antibiotic, versus twice-daily oral linezolid for treatment of ABSSSI. METHODS In this phase 3, double-blind, randomised, non-inferiority study, eligible adults with ABSSSI at 33 sites in the USA were randomly assigned (1:1) to receive omadacycline (450 mg orally every 24 h over the first 48 h then 300 mg orally every 24 h) or linezolid (600 mg orally every 12 h) for 7-14 days. Randomisation was done via an interactive response system using a computer-generated schedule, and stratified by type of infection (wound infection, cellulitis or erysipelas, or major abscess) and receipt (yes or no) of allowed previous antibacterial treatment. Investigators, funders, and patients were masked to treatment assignments. Primary endpoints were early clinical response, 48-72 h after first dose, in the modified intention-to-treat (mITT) population (randomised patients without solely Gram-negative ABSSSI pathogens at baseline), and investigator-assessed clinical response at post-treatment evaluation, 7-14 days after the last dose, in the mITT population and clinically evaluable population (ie, mITT patients who had a qualifying infection as per study-entry criteria, received study drug, did not receive a confounding antibiotic, and had an assessment of outcome during the protocol-defined window). The safety population included randomised patients who received any amount of study drug. We set a non-inferiority margin of 10%. This study is registered with ClinicalTrials.gov, NCT02877927, and is complete. FINDINGS Between Aug 11, 2016, and June 6, 2017, 861 participants were assessed for eligibility. 735 participants were randomly assigned, of whom 368 received omadacycline and 367 received linezolid. Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (percentage-point difference 5·0, 95% CI -0·2 to 10·3) in the mITT population. For investigator-assessed clinical response at post-treatment evaluation, omadacycline was non-inferior to linezolid in the mITT (303 [84%] of 360 vs 291 [81%] of 360; percentage-point difference 3·3, 95% CI -2·2 to 9·0) and clinically evaluable (278 [98%] of 284 vs 279 [96%] of 292; 2·3, -0·5 to 5·8) populations. Mild to moderate nausea and vomiting were the most frequent treatment-emergent adverse events in omadacycline (111 [30%] of 368 and 62 [17%] of 368, respectively) and linezolid (28 [8%] of 367 and 11 [3%] of 367, respectively) groups. INTERPRETATION Once-daily oral omadacycline was non-inferior to twice-daily oral linezolid in adults with ABSSSI, and was safe and well tolerated. Oral-only omadacycline represents a new treatment option for ABSSSI, with potential for reduction in hospital admissions and cost savings. FUNDING Paratek Pharmaceuticals.",2019,Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (,"['acute bacterial skin and skin structure infections (OASIS-2', '861 participants were assessed for eligibility', 'eligible adults with ABSSSI at 33 sites in the USA', '735 participants', 'Between Aug 11, 2016, and June 6, 2017']","['linezolid', 'Omadacycline', 'Oral-only omadacycline', 'omadacycline versus twice-daily oral linezolid', 'omadacycline']","['moderate nausea and vomiting', 'efficacy and safety', 'safe and well tolerated']","[{'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C2983838', 'cui_str': 'omadacycline'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",735.0,0.503444,Omadacycline (315 [88%] of 360) was non-inferior to linezolid (297 [83%] of 360) for early clinical response (,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Riordan"", 'Affiliation': 'eStudySite, San Diego, CA, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cardenas', 'Affiliation': 'eStudySite, San Diego, CA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Jubilee Clinical Research, Las Vegas, NV, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Sirbu', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Garrity-Ryan', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA. Electronic address: lynne.garrity-ryan@paratekpharma.com.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stats Consulting, Guerneville, CA, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manley', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Judith N', 'Initials': 'JN', 'LastName': 'Steenbergen', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Tzanis', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'McGovern', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Loh', 'Affiliation': 'Paratek Pharmaceuticals, King of Prussia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30275-0'] 1494,31547752,"Agitation, Oxidative Stress, and Cytokines in Alzheimer Disease: Biomarker Analyses From a Clinical Trial With Nabilone for Agitation.","The endocannabinoid system has been a target of interest for agitation in Alzheimer disease (AD) because of potential behavioral effects and its potential impact on mechanisms implicated in AD such as oxidative stress (OS) and neuroinflammation. We explored whether serum markers of OS and neuroinflammation were associated with response to the cannabinoid nabilone in agitated patients with AD (N = 38). All participants were enrolled in a 14-week, double-blind, cross-over trial comparing nabilone to placebo (6 weeks each) with a 1-week washout between phases. Samples were collected at the start and end of each phase. The cross-sectional relationship agitation (Cohen Mansfield Agitation Inventory) and OS and inflammatory markers were investigated to select markers of interest. Significant markers were then explored for their relationship with response. The OS marker, 4-hydroxynonenal (4-HNE; F 1, 35 = 6.41, P = .016), and the proinflammatory cytokine, tumor necrosis factor-α (TNF-α; F 1, 29 = 3.97, P = .06), were associated with agitation severity, and TNF-α remained significantly associated ( F 2, 25 = 3.69, P = .04) after adjustment for cognition. In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01, P = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14, P = .045). Changes in 4-HNE were not associated with changes in agitation severity in either phase. In the nabilone phase, lower baseline TNF-α was associated with decreases in agitation severity (b = 1.14, P = .045), and decreases in TNF-α were associated with decreases in agitation severity (b = 1.12, P = .006). These findings suggest that OS and neuroinflammation may be associated with agitation severity, while nabilone may have anti-inflammatory effects.",2020,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01, P = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14, P = .045).","['Alzheimer Disease', 'agitated patients with AD (N = 38']",['placebo'],"['TNF-α', 'agitation severity', 'Agitation, Oxidative Stress, and Cytokines', 'agitation severity, and TNF-α', 'serum markers of OS and neuroinflammation', 'proinflammatory cytokine, tumor necrosis factor-α']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",,0.190073,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01, P = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14, P = .045).","[{'ForeName': 'Myuri', 'Initials': 'M', 'LastName': 'Ruthirakuhan', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Andreazza', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicolaas Paul L G', 'Initials': 'NPLG', 'LastName': 'Verhoeff', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719874118'] 1495,31549903,Use of a Bidirectional Text Messaging System for Emergency Department Follow-Up Versus Usual Follow-Up.,"Background: The use of text messaging is a growing trend. Usual care for follow-up with patients (no dedicated communication) has proven unreliable, and alternative communication methods may be beneficial. Introduction: The objective was to evaluate the effect of text messaging as a means of follow-up communication compared to usual care on patient satisfaction among patients discharged from the emergency department (ED). Materials and Methods: Participants completed a baseline survey about their text message usage and ED visit satisfaction. The participants completed a follow-up survey 2 weeks later. Participants randomized to text messaging received a text message at 24 h, 1 week, and 2 weeks after discharge. Control participants received usual care (typically no dedicated communication). Bivariate analyses were performed, and intent-to-treat and per protocol analyses were completed to examine follow-up satisfaction with ED communication/care. Results: A total of 802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects). In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects. In per-protocol analysis, text messaging subjects had 2.95 (1.52-5.73) higher odds of reporting satisfaction with follow-up communication and 3.24 (1.46-7.16) higher odds of reporting satisfaction with follow-up care. Discussion: The use of text messaging for follow-up, when comparing satisfaction with follow-up communication and follow-up care after discharge, performs at least equally as well as usual follow-up. Conclusions: Text messaging is a provider time-saving and resource-conserving technology allowing health care providers to potentially reach a larger proportion of patients, making it a valuable form of follow-up communication.",2020,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","['patients discharged from the emergency department (ED', '802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects']","['Bidirectional Text Messaging System', 'usual care (typically no dedicated communication', 'text messaging']",[],"[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],802.0,0.0576994,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","[{'ForeName': 'Brooks J', 'Initials': 'BJ', 'LastName': 'Obr', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Young', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Karisa K', 'Initials': 'KK', 'LastName': 'Harland', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nugent', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0002'] 1496,31550080,"Free mucosal grafts and anterior pedicled flaps to prevent ostium restenosis after endoscopic modified Lothrop (frontal drillout) procedure: a randomized, controlled study.","BACKGROUND The endoscopic modified Lothrop procedure (EMLP) is used to manage ongoing refractory frontal sinusitis after failed previous endoscopic sinus surgery (ESS), but this approach has a significant restenosis rate. We evaluated the potential benefits of mucosal grafts and pedicled flaps on the opening of the newly formed frontal ostium. METHODS Fifty patients with refractory frontal sinusitis or mucoceles after ESS were randomized to undergo EMLP, either with (n = 27) or without (n = 23) mucosal grafts and pedicled flap reconstruction of the neo-ostium. The frontal neo-ostium was measured with Lindholm distending forceps, and anteroposterior (A-P) and lateral dimensions were measured intraoperatively, and then again at 6 weeks, 6 months, and 12 months postoperatively. Olfaction outcomes were assessed using the Taiwan Smell Identification Test (TWSIT) and a smell visual analog scale (VAS) score preoperatively and at 6 months postsurgery. RESULTS The initial intraoperative mean lateral and A-P dimensions were 23.2 ± 2.7 mm and 14.8 ± 2.3 mm and were significantly decreased at all time-points postoperatively. The mucosal grafts and pedicled flaps had greater lateral and A-P dimensions, and a greater percentage of intraoperative frontal neo-ostium area at all time-points postoperatively (all p < 0.05). At 6 months postoperatively, TWSIT (p = 0.027), but not the smell VAS score (p = 0.063), was significantly improved compared with baseline. TWSIT and smell VAS score changes did not differ between groups (p = 0.92 and p = 0.85, respectively). CONCLUSION The use of mucosal grafts and pedicled flaps reduces stenosis of the frontal neo-ostium postsurgery and should be considered after EMLP.",2019,The use of mucosal grafts and pedicled flaps reduces stenosis of the frontal neo-ostium postsurgery and should be considered after EMLP.,['Fifty patients with refractory frontal sinusitis or mucoceles after ESS'],"['endoscopic modified Lothrop procedure (EMLP', 'mucosal grafts and pedicled flap reconstruction of the neo-ostium', 'EMLP', 'endoscopic modified Lothrop (frontal drillout) procedure', 'mucosal grafts and pedicled flaps']","['ostium restenosis', 'Taiwan Smell Identification Test (TWSIT) and a smell visual analog scale (VAS) score', 'smell VAS score', 'initial intraoperative mean lateral and A-P dimensions', 'intraoperative frontal neo-ostium area', 'TWSIT and smell VAS score changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0016735', 'cui_str': 'Frontal Sinusitis'}, {'cui': 'C0026683', 'cui_str': 'Mucocele'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft (substance)'}, {'cui': 'C0450136', 'cui_str': 'Pedicle flap (substance)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0444567', 'cui_str': 'Ostium (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}]","[{'cui': 'C0444567', 'cui_str': 'Ostium (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",50.0,0.0364556,The use of mucosal grafts and pedicled flaps reduces stenosis of the frontal neo-ostium postsurgery and should be considered after EMLP.,"[{'ForeName': 'Ying-Piao', 'Initials': 'YP', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ping-Hung', 'Initials': 'PH', 'LastName': 'Shen', 'Affiliation': 'Department of Otolaryngology, Kuang-Tien General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Li-Chun', 'Initials': 'LC', 'LastName': 'Hsieh', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Peter-John', 'Initials': 'PJ', 'LastName': 'Wormald', 'Affiliation': 'Department of Surgery-Otolaryngology Head and Neck Surgery, University of Adelaide, Adelaide, Australia.'}]",International forum of allergy & rhinology,['10.1002/alr.22416'] 1497,30819460,Leveraging technology: A multi-component personalized system of instruction to teach sight words.,"Technology-enabled personalized systems of instruction (PSI) could streamline resource-intensive instructional strategies, potentially easing their delivery and accelerating student learning. This study evaluated the effectiveness and efficiency of a PSI that incorporated adaptive assessment, incremental rehearsal, and peer-assisted learning to teach sight words. Participants in grades 1-3 were randomly assigned to either a control condition or treatment condition. In the treatment condition, participants engaged in the PSI in dyads, working at their instructional level with minimal adult supervision. Compared to the control condition, target learners engaging in the PSI acquired previously unknown sight words, then maintained and generalized the words 30 days post-intervention with a moderate main effect (β = 0.28). On average, participants rated the PSI as positive or very positive. The potential for PSIs to make instructional activities more efficient, effective, and individualized is discussed.",2019,"Compared to the control condition, target learners engaging in the PSI acquired previously unknown sight words, then maintained and generalized the words 30 days post-intervention with a moderate main effect (β = 0.28).",['Participants in grades 1-3'],"['control condition or treatment condition', 'Leveraging technology']",[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",[],,0.018728,"Compared to the control condition, target learners engaging in the PSI acquired previously unknown sight words, then maintained and generalized the words 30 days post-intervention with a moderate main effect (β = 0.28).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Hammerschmidt-Snidarich', 'Affiliation': 'University of Minnesota, Twin Cities, United States of America. Electronic address: snida009@umn.edu.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Edwards', 'Affiliation': 'University of Minnesota, Twin Cities, United States of America. Electronic address: edwardsl@umn.edu.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Christ', 'Affiliation': 'University of Minnesota, Twin Cities, United States of America. Electronic address: tchrist@umn.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Thayer', 'Affiliation': 'University of Minnesota, Twin Cities, United States of America. Electronic address: thaye053@umn.edu.'}]",Journal of school psychology,['10.1016/j.jsp.2018.12.005'] 1498,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL). MATERIALS AND METHODS Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week). RESULTS The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found. CONCLUSION No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020'] 1499,31516127,A Smartphone App to Improve Medication Adherence in Patients With Type 2 Diabetes in Asia: Feasibility Randomized Controlled Trial.,"BACKGROUND The efficacy of smartphone apps for improving medication adherence in type 2 diabetes is not well studied in Asian populations. OBJECTIVE This study aimed to determine the feasibility, acceptability, and clinical outcomes of using a smartphone app to improve medication adherence in a multiethnic Asian population with type 2 diabetes. METHODS We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control: usual care; intervention: usual care+Medisafe app) and followed them up for 12 weeks. Recruitment occurred at a public tertiary diabetes specialist outpatient center in Singapore. The intervention group received email reminders to complete online surveys monthly, while the control group only received an email reminder(s) at the end of the study. Barriers to medication adherence and self-appraisal of diabetes were assessed using the Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires at baseline and poststudy in both groups. Perception toward medication adherence and app usage, attitude, and satisfaction were assessed in the intervention group during and after the follow-up period. Sociodemographic data were collected at baseline. Clinical data (ie, hemoglobin A 1c , body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels) were extracted from patients' electronic medical records. RESULTS A total of 51 (intervention group: 25 [49%]; control group: 26 [51%]) participants were randomized, of which 41 (intervention group: 22 [88.0%]; control group: 19 [73.1%]) completed the poststudy survey. The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01). No changes were observed in the clinical outcomes. The average 12-week medication adherence rate of participants tracked by the app was between 38.3% and 100% in the intervention group. The majority (>80%) of the participants agreed that the app was easy to use and made them more adherent to their medication. CONCLUSIONS Our feasibility study showed that among medication-nonadherent patients with type 2 diabetes, a smartphone app intervention was acceptable, improved awareness of medication adherence, and reduced self-reported barriers to medication adherence, but did not improve clinical outcomes in a developed Asian setting.",2019,"The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01).","['public tertiary diabetes specialist outpatient center in Singapore', 'Patients With Type 2 Diabetes in Asia', 'We block randomized 51 nonadherent and digitally literate patients with type 2 diabetes between the ages of 21 and 75 years into two treatment arms (control', 'multiethnic Asian population with type 2 diabetes']","['usual care; intervention: usual care+Medisafe app', 'smartphone', 'smartphone app', 'email reminders to complete online surveys monthly, while the control group only received an email reminder(s']","['average 12-week medication adherence rate', 'medication adherence', 'awareness of medication adherence', 'baseline-adjusted poststudy ASK-12 score', 'Medication Adherence', 'Adherence Starts with Knowledge-12 (ASK-12) and Appraisal of Diabetes Scale (ADS) questionnaires', 'Perception toward medication adherence and app usage, attitude, and satisfaction', 'Clinical data (ie, hemoglobin A 1c , body mass index, low-density lipoprotein, high-density lipoprotein, and total cholesterol levels']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",,0.0472011,"The baseline-adjusted poststudy ASK-12 score was significantly lower in the intervention group than in the control group (mean difference: 4.7, P=.01).","[{'ForeName': 'Zhilian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Eberta', 'Initials': 'E', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sloot', 'Affiliation': 'Complexity Institute, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Bernhard Otto', 'Initials': 'BO', 'LastName': 'Boehm', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",JMIR mHealth and uHealth,['10.2196/14914'] 1500,32417537,Dual X-ray absorptiometry has limited utility in detecting bone pathology in children with hypophosphatasia: A pooled post hoc analysis of asfotase alfa clinical trial data.,"Asfotase alfa is an enzyme replacement therapy approved for treatment of patients with pediatric-onset hypophosphatasia (HPP), a rare, inherited, systemic disease causing impaired skeletal mineralization, short stature, and reduced physical function in children. The role of dual X-ray absorptiometry (DXA) in the assessment of children with HPP has been insufficiently explored. This post hoc analysis included pooled DXA data from 2 open-label, multicenter studies in 19 children with HPP. The study population was aged ≥5 to <18 years and had received asfotase alfa for ≤6.6 years at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7]; treatment duration: 6.3 y [range: 0.1-6.6]. Baseline height Z-scores indicated short stature (median [min, max]: -1.26 [-6.6, 0]); mean [SD]: -2.30 [1.97]), thus requiring height adjustment of DXA Z-scores. At Baseline, few patients had height-adjusted bone mineral density (BMD ht ) Z-scores of -2 or less for whole body (n = 3) or lumbar spine (n = 5). In treated patients, mean whole body and lumbar spine BMD ht Z-scores did not change over time, but whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores increased significantly from Baseline to Last Assessment (P ≤ 0.0056). Improvements in Radiographic Global Impression of Change (RGI-C) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores. Improvements in Rickets Severity Score (RSS) correlated significantly with increases in lumbar spine BMD ht Z-scores and whole body BMC ht Z-scores (P < 0.05). No significant correlations were observed between any DXA and bone histomorphometry measure. These findings suggest that DXA BMD Z-scores, which are commonly used in clinical practice, have limited utility in assessing deficient bone mineralization in patients with HPP. Although BMC ht Z-scores increased significantly over time with asfotase alfa therapy, the lack of significant changes in more than one DXA parameter suggests that this tool may not be useful in everyday clinical practice. Furthermore, the use of BMC as an independent metric is not typical or recommended by guidelines. Complementary measures, such as skeletal radiographs supplemented with age-appropriate functional assessments, should be considered.",2020,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"['patients with pediatric-onset hypophosphatasia (HPP', 'children with hypophosphatasia', 'The study population was aged ≥5 to <18\u202fyears and had received asfotase alfa for ≤6.6\u202fyears at enrollment (male: 79%; median age at enrollment: 10.4 y [range: 5.9-16.7];]; treatment duration: 6.3 y [range: 0.1-6.6', '19 children with HPP', 'patients with HPP', 'children with HPP']","['dual X-ray absorptiometry (DXA', 'Dual X-ray absorptiometry']","['BMC ht Z-scores', 'whole body and lumbar spine height- adjusted bone mineral content (BMC ht ) Z-scores', 'mean [SD', 'Rickets Severity Score (RSS', 'mean whole body and lumbar spine BMD ht Z-scores', 'Radiographic Global Impression of Change (RGIC) scale scores', 'DXA and bone histomorphometry measure', 'lumbar spine BMD ht Z-scores and whole body', 'height-adjusted bone mineral density (BMD ht ) Z-scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020630', 'cui_str': 'Hypophosphatasia'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3490795', 'cui_str': 'asfotase alfa'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0200771', 'cui_str': 'Bone histomorphometry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",19.0,0.0447297,Improvements in Radiographic Global Impression of Change (RGIC) scale scores correlated significantly with increases in whole body and lumbar spine BMC ht Z-scores (P < 0.05) but not BMD ht Z-Scores.,"[{'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Vanderbilt University, Village at Vanderbilt, 1500 21st Ave South, Suite 1514, Nashville, TN 37212, USA. Electronic address: jill.h.simmons@vumc.org.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Rush', 'Affiliation': ""Department of Pediatrics, Children's Mercy Kansas City, Adele Hall Campus, 2401 Gillham Rd, Kansas City, MO 64108, USA; University of Missouri - Kansas City School of Medicine, 2411 Holmes St, Kansas City, MO 64108, USA; University of Kansas School of Medicine, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: etrush@cmh.edu.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Petryk', 'Affiliation': 'Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210, USA. Electronic address: Anna.Petryk@alexion.com.'}, {'ForeName': 'Shanggen', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Clinical Development Services-Corporate, Covance, Inc., 210 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: shanggen.zhou@covance.com.'}, {'ForeName': 'Gabriel Á', 'Initials': 'GÁ', 'LastName': 'Martos-Moreno', 'Affiliation': 'Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, IIS La Princesa, Av. de Menéndez Pelayo, 65, 28009 Madrid, Spain; Department of Pediatrics, Universidad Autónoma de Madrid, Calle Arzobispo Morcillo, 4, 28029 Madrid, Spain; CIBERobn, Instituto de Salud Carlos III, C/ Sinesio Delgado, 4, 28029 Madrid, Spain. Electronic address: gabrielangelmartos@yahoo.es.'}]",Bone,['10.1016/j.bone.2020.115413'] 1501,32417629,"Melatonin supplementation and the effects on clinical and metabolic status in Parkinson's disease: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE This study was performed to evaluate the impact of melatonin supplementation on clinical and metabolic profiles in people with Parkinson's disease (PD). METHODS This randomized, double-blind, placebo-controlled clinical trial was conducted among 60 patients with PD. Participants were randomly divided into two groups to intake either 10 mg melatonin (two melatonin capsules, 5 mg each) (n = 30) or placebo (n = 30) once a day, 1 h before bedtime for 12 weeks. RESULTS Melatonin supplementation significantly reduced the Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β -2.33; 95% CI, -3.57, -1.09; P < 0.001), Pittsburgh Sleep Quality Index (PSQI) (β -1.82; 95% CI, -3.36, -0.27; P = 0.02), Beck Depression Inventory (BDI) (β -3.32; 95% CI, -5.23, -1.41; P = 0.001) and Beck Anxiety Inventory (BAI) (β -2.22; 95% CI, -3.84, -0.60; P = 0.008) compared with the placebo treatment. Compared with the placebo, melatonin supplementation resulted in a significant reduction in serum high sensitivity C-reactive protein (hs-CRP) (β -0.94 mg/L; 95% CI, -1.55, -0.32; P = 0.003) and a significant elevation in plasma total antioxidant capacity (TAC) (β 108.09 mmol/L; 95% CI, 78.21, 137.97; P < 0.001) and total glutathione (GSH) levels (β 77.08 μmol/L; 95% CI, 44.29, 109.86; P < 0.001). Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β -13.16 mg/dL; 95% CI, -25.14, -1.17; P = 0.03) and LDL- (β -10.44 mg/dL; 95% CI, -20.55, -0.34; P = 0.04) compared with the placebo. CONCLUSIONS Overall, melatonin supplementation for 12 weeks to patients with PD had favorable effects on the UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR, but did not affect other metabolic profiles.",2020,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[""Parkinson's disease"", ""people with Parkinson's disease (PD"", '60 patients with PD']","['melatonin supplementation', 'Melatonin supplementation', 'placebo, melatonin supplementation', 'melatonin (two melatonin capsules', 'placebo']","['Pittsburgh Sleep Quality Index (PSQI', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'UPDRS part I score, PSQI, BDI, BAI, hs-CRP, TAC, GSH, insulin levels, HOMA-IR, total-, LDL-cholesterol, and gene expression of TNF-α, PPAR-γ and LDLR', 'serum high sensitivity C-reactive protein (hs-CRP', 'plasma total antioxidant capacity (TAC', 'total glutathione (GSH) levels', 'LDL', 'Beck Anxiety Inventory (BAI) ', 'Beck Depression Inventory (BDI', 'serum insulin levels', ""Unified Parkinson's Disease Rating Scale (UPDRS) part I score (β""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0034821', 'cui_str': 'LDL receptor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",60.0,0.782673,"Additionally, consuming melatonin significantly decreased serum insulin levels (β -1.79 μIU/mL; 95% CI, -3.12, -0.46; P = 0.009), homeostasis model of assessment-insulin resistance (HOMA-IR) (β -0.47; 95% CI, -0.80, -0.13; P = 0.007), total- (β","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Infectious Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran; Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'J Reiter', 'Affiliation': 'Department of Cellular and Structural Biology, University of Texas Health Science, Center, San Antonio, TX, USA.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_z@Kaums.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105878'] 1502,26096844,Effect of in-painting on cortical thickness measurements in multiple sclerosis: A large cohort study.,"A comprehensive analysis of the effect of lesion in-painting on the estimation of cortical thickness using magnetic resonance imaging was performed on a large cohort of 918 relapsing-remitting multiple sclerosis patients who participated in a phase III multicenter clinical trial. An automatic lesion in-painting algorithm was developed and implemented. Cortical thickness was measured using the FreeSurfer pipeline with and without in-painting. The effect of in-painting was evaluated using FreeSurfer's paired analysis pipeline. Multivariate regression analysis was also performed with field strength and lesion load as additional factors. Overall, the estimated cortical thickness was different with in-painting than without. The effect of in-painting was observed to be region dependent, more significant in the left hemisphere compared to the right, was more prominent at 1.5 T relative to 3 T, and was greater at higher lesion volumes. Our results show that even for data acquired at 1.5 T in patients with high lesion load, the mean cortical thickness difference with and without in-painting is ∼2%. Based on these results, it appears that in-painting has only a small effect on the estimated regional and global cortical thickness. Hum Brain Mapp 36:3749-3760, 2015. © 2015 Wiley Periodicals, Inc.",2015,"The effect of in-painting was observed to be region dependent, more significant in the left hemisphere compared to the right, was more prominent at 1.5 T relative to 3 T, and was greater at higher lesion volumes.","['918 relapsing-remitting multiple sclerosis patients who participated in a phase III multicenter clinical trial', 'multiple sclerosis']","['magnetic resonance imaging', 'painting']","['Cortical thickness', 'cortical thickness measurements', 'estimated cortical thickness']","[{'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0581155,"The effect of in-painting was observed to be region dependent, more significant in the left hemisphere compared to the right, was more prominent at 1.5 T relative to 3 T, and was greater at higher lesion volumes.","[{'ForeName': 'Koushik A', 'Initials': 'KA', 'LastName': 'Govindarajan', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Khader M', 'Initials': 'KM', 'LastName': 'Hasan', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Sangbum', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Division of Clinical and Translational Sciences, Internal Medicine, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Rahbar', 'Affiliation': 'Division of Clinical and Translational Sciences, Internal Medicine, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Stacey S', 'Initials': 'SS', 'LastName': 'Cofield', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine, New York, New York.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': 'Ponnada A', 'Initials': 'PA', 'LastName': 'Narayana', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, University of Texas Medical School at Houston, Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22875'] 1503,32417925,A Randomized Trial to Compare Serratus Anterior Plane Block and Erector Spinae Plane Block for Pain Management Following Thoracoscopic Surgery.,"OBJECTIVE Comparison of ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in video-assisted thoracic surgery (VATS) patients. The primary outcome was to compare perioperative and postoperative (48 hours) opioid consumption. METHODS A total of 60 patients were randomized into two groups (N = 30): an ESPB group and an SAPB group. All the patients received intravenous patient-controlled postoperative analgesia and ibuprofen 400 mg intravenously every eight hours. Visual analog scale (VAS) scores, opioid consumption, and adverse events were recorded. RESULTS Intraoperative and postoperative opioid consumption at 0-8, 8-16, and 16-24 hours and rescue analgesic use were significantly lower in the ESPB group (P < 0.05). Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05). There was no significant difference between static VAS scores at the fourth hour. There were no differences between adverse effects. Block procedure time and one-time puncture success were similar between groups (P  > 0.05 each). CONCLUSION US-guided ESPB may provide better pain control than SAPB after VATS. QUESTION Even though there are studies about analgesia management after VATS, clinicians want to perform the technique that is both less invasive and more effective. FINDINGS This randomized trial showed that US-guided ESPB provides effective analgesia compared with SAPB. MEANING Performing single-injection ESPB reduces VAS scores and opioid consumption compared with SAPB.",2020,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"['Pain Management Following Thoracoscopic Surgery', '60 patients', 'video-assisted thoracic surgery (VATS) patients']","['Serratus Anterior Plane Block and Erector Spinae Plane Block', 'ESPB', 'US-guided ESPB', 'intravenous patient-controlled postoperative analgesia and ibuprofen', 'VATS', 'ultrasound (US)-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB']","['VAS scores and opioid consumption', 'Static/dynamic VAS scores', 'Intraoperative and postoperative opioid consumption', 'perioperative and postoperative (48 hours) opioid consumption', 'Visual analog scale (VAS) scores, opioid consumption, and adverse events', 'rescue analgesic use', 'Block procedure time and one-time puncture success', 'adverse effects', 'static VAS scores']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",60.0,0.139796,Static/dynamic VAS scores were significantly lower in the ESPB group (P < 0.05).,"[{'ForeName': 'Mürsel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Birzat Emre', 'Initials': 'BE', 'LastName': 'Gölboyu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Manisa State Hospital, Manisa, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Medipol University, School of Medicine, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bayrak', 'Affiliation': 'Department of Thoracic Surgery, Istanbul Medipol University, Mega Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Tulgar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maltepe University, Istanbul, Turkey.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa101'] 1504,32417812,Reducing lumbar spine flexion using real-time biofeedback during patient handling tasks.,"BACKGROUND Patient handling activities require caregivers to adopt postures that increase the risk of back injury. Training programs relying primarily on didactic methods have been shown to be ineffective at reducing this risk. The use of real-time biofeedback has potential as an alternative training method. OBJECTIVE To investigate the effect of real-time biofeedback on time spent by caregivers in end-range lumbar spine flexion. METHODS Novice participants were divided into intervention (n = 10) and control (n = 10) groups and were asked to perform a set of simulated care activities eight times on two consecutive days. Individuals in the intervention group watched a training video on safer movement strategies and received real-time auditory feedback from a wearable device (PostureCoach) in four training trials whenever their lumbar spine flexion exceeded a threshold (70% of maximum flexion). Changes in end-range lumbar spine flexion were compared between groups and across trials. RESULTS Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group. CONCLUSIONS The training program including PostureCoach has the potential to help caregivers learn to use safer postures that reduce the risk of back injury.",2020,"RESULTS Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group. ",['Novice participants'],"['training video on safer movement strategies and received real-time auditory feedback from a wearable device (PostureCoach', 'real-time biofeedback']","['end-range lumbar spine flexion', 'lumbar spine flexion']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",,0.0415063,"RESULTS Participants in the intervention group saw reductions in end-range lumbar spine flexion during the simulated patient handling tasks at the end of the training compared to their baseline trials while there was no change for the control group. ","[{'ForeName': 'Mohammadhasan', 'Initials': 'M', 'LastName': 'Owlia', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kamachi', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, ON, Canada.'}]","Work (Reading, Mass.)",['10.3233/WOR-203149'] 1505,32417819,The effects of background music tempo on the work attention performance of workers with schizophrenia.,"BACKGROUND Work attention in employees with schizophrenia is a significant issue in vocational rehabilitation. Background music is very popular in workplaces, and according to some investigations, can help increase attention at work if utilized appropriately. OBJECTIVE This study investigates the influence of background music tempo on attention performance in employees with chronic schizophrenia. METHODS A randomized controlled trial (RCT) study was performed to test the attention of 240 participants with chronic schizophrenia under four conditions, namely no music, fast tempo, slow tempo and white noise. RESULTS Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment. Additionally, slow-tempo music produced higher attention scores than fast-tempo music. CONCLUSIONS Observational results indicate that slow-tempo background music is more desirable than fast-tempo background music in a work environment involving schizophrenic individuals.",2020,"RESULTS Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment.","['240 participants with chronic schizophrenia under four conditions, namely no music, fast tempo, slow tempo and white noise', 'workers with schizophrenia', 'employees with chronic schizophrenia', 'Employees with schizophrenia', 'employees with schizophrenia']","['background music tempo', 'slow-tempo music']","['attention performance', 'higher attention scores', 'attention scores']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",240.0,0.211361,"RESULTS Employees with schizophrenia achieved higher attention scores under background music than in a no-music environment.","[{'ForeName': 'Yi-Nuo', 'Initials': 'YN', 'LastName': 'Shih', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Kuo-Hsin', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'Taipei Veterans General Hospital Yuli Branch, Hualien, Taiwan.'}, {'ForeName': 'Chia-Chun', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}]","Work (Reading, Mass.)",['10.3233/WOR-203156'] 1506,32418142,Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.,"INTRODUCTION Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients. METHODS In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups. RESULTS In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. CONCLUSION MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01735305.",2020,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. ","['Medically Managed Acute Coronary Syndrome Patients', 'Chinese Patients with Coronary Artery Disease', 'medically managed acute coronary syndrome (ACS) (MMACS) patients']","['DAPT', 'antiplatelet therapy (DAPT) duration', 'percutaneous coronary intervention', 'MMACS']","['rate of primary efficacy endpoint', 'Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events', 'Propensity score matching (PSM', 'bleeding risks', 'ischemic events', 'all bleeding, BARC 2-5, and BARC 3-5 bleeding', 'efficacy and safety of\u2009≥', 'composite of cardiac death, myocardial infarction, and stroke']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0365972,"After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. ","[{'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Miaohan', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China. han1320288258@qq.com.'}]",Advances in therapy,['10.1007/s12325-020-01376-0'] 1507,32424821,Evaluation of Very Integrated Program: Health Promotion for Patients With Alcohol and Drug Addiction-A randomized Trial.,"BACKGROUND Compared to the general population, patients with alcohol and drug addiction have an increased risk of additional hazardous lifestyles and suffer from more chronic diseases, adding to their already significantly higher morbidity and mortality. The objective of this study was to test the efficacy of the Very Integrated Program (VIP) on treatment and health outcomes for patients diagnosed with alcohol and drug addiction. METHODS Parallel randomized clinical trial with intervention as add-on to addiction care as usual. A total of 322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot. The intervention was a 6-week intensive, tailored, educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education. The main outcome measures were substance-free days, time to relapse, and treatment adherence assessed after 6 weeks and 12 months. Secondary outcomes were lifestyle factors, symptoms of comorbidity, and quality of life. Missing data were imputed conservatively by using data closest to the follow-up date and baseline values in patients with no follow-up. RESULTS The 212 patients (intervention, n = 113; control, n = 99) were randomized, and 202 had complete data for primary outcomes. After 6 weeks, there were no significant differences between the groups regarding primary or secondary outcomes. At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0 to 365 vs. 265; 0 to 366, p = 0.021)-specifically among the patients with drug addiction-and higher physical and mental quality of life (45 vs. 58, p = 0.049 and 54 vs. 66, p = 0.037), but not in the per-protocol analysis (60 vs. 46, p = 0.52 and 70 vs. 66, p = 0.74). The sensitivity analyses did not support significant differences between the groups. CONCLUSION Overall, adding VIP intervention did not improve outcome of the alcohol or drug addiction care or the lifestyle compared to the addiction care alone. This patient group is still in need of effective programs, and new intervention research is required to develop that.",2020,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","['212 patients (intervention, n=113; control, n=99', 'patients diagnosed with alcohol and drug addiction', '322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot', 'patients with alcohol and drug addiction ']","['educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education', 'Very Integrated Program (VIP', 'Very Integrated Program (VIP): Health promotion']","['substance-free days, time to relapse and treatment adherence', 'total substance-free days', 'alcohol or drug addiction care or the lifestyle', 'physical and mental quality of life', 'lifestyle factors, symptoms of comorbidity, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",322.0,0.0700003,"At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hovhannisyan', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Adami', 'Affiliation': 'Sophiahemmet University, (JA), Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wikström', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'From the, Department of Health Science, (KH, MR, MW, HT), Clinical Health Promotion Centre, WHO-CC, Region Skåne, Lund University, Lund, Sweden.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14364'] 1508,26010878,Finding the self by losing the self: Neural correlates of ego-dissolution under psilocybin.,"Ego-disturbances have been a topic in schizophrenia research since the earliest clinical descriptions of the disorder. Manifesting as a feeling that one's ""self,"" ""ego,"" or ""I"" is disintegrating or that the border between one's self and the external world is dissolving, ""ego-disintegration"" or ""dissolution"" is also an important feature of the psychedelic experience, such as is produced by psilocybin (a compound found in ""magic mushrooms""). Fifteen healthy subjects took part in this placebo-controlled study. Twelve-minute functional MRI scans were acquired on two occasions: subjects received an intravenous infusion of saline on one occasion (placebo) and 2 mg psilocybin on the other. Twenty-two visual analogue scale ratings were completed soon after scanning and the first principal component of these, dominated by items referring to ""ego-dissolution"", was used as a primary measure of interest in subsequent analyses. Employing methods of connectivity analysis and graph theory, an association was found between psilocybin-induced ego-dissolution and decreased functional connectivity between the medial temporal lobe and high-level cortical regions. Ego-dissolution was also associated with a ""disintegration"" of the salience network and reduced interhemispheric communication. Addressing baseline brain dynamics as a predictor of drug-response, individuals with lower diversity of executive network nodes were more likely to experience ego-dissolution under psilocybin. These results implicate MTL-cortical decoupling, decreased salience network integrity, and reduced inter-hemispheric communication in psilocybin-induced ego disturbance and suggest that the maintenance of ""self""or ""ego,"" as a perceptual phenomenon, may rest on the normal functioning of these systems.",2015,"Ego-dissolution was also associated with a ""disintegration"" of the salience network and reduced interhemispheric communication.",['Fifteen healthy subjects'],"['intravenous infusion of saline on one occasion (placebo) and 2 mg psilocybin', 'placebo']","['visual analogue scale ratings', 'salience network integrity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0033850', 'cui_str': 'Psilocybin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",15.0,0.0209157,"Ego-dissolution was also associated with a ""disintegration"" of the salience network and reduced interhemispheric communication.","[{'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center, Karolinska Institutet & Stockholm University, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center, Karolinska Institutet & Stockholm University, Sweden.'}, {'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ben-Gurion University of the Negev, Israel.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Nutt', 'Affiliation': 'Division of Brain Sciences, Department of Medicine, Centre for Neuropsychopharmacology, Imperial College London, United Kingdom.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Carhart-Harris', 'Affiliation': 'Division of Brain Sciences, Department of Medicine, Centre for Neuropsychopharmacology, Imperial College London, United Kingdom.'}]",Human brain mapping,['10.1002/hbm.22833'] 1509,32418302,A pilot non-inferiority randomized controlled trial to assess automatic adjustments of insulin doses in adolescents with type 1 diabetes on multiple daily injections therapy.,"BACKGROUND Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users. METHODS We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes. RESULTS Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis. CONCLUSIONS In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.",2020,"There was no incidence of severe hypoglycemia nor ketoacidosis. ","['MDI therapy users', '21 youths (age 13.3 (SD, 3.7) years; 13 females; HbA1c 8.6% (SD, 1.8', 'Adolescents with Type 1 Diabetes on Multiple Daily Injections Therapy', 'children and adolescents on MDI therapy']","['basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA', 'Multiple daily injections (MDI) therapy']","['glycemic outcomes', 'time in target glucose', 'severe hypoglycemia nor ketoacidosis', 'number of hypoglycemic events']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",293.0,0.0480095,"There was no incidence of severe hypoglycemia nor ketoacidosis. ","[{'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Electrical and Computer Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Palisaitis', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'von Oettingen', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Krishnamoorthy', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}]",Pediatric diabetes,['10.1111/pedi.13052'] 1510,31135540,CORR Insights®: Small Social Incentives Did Not Improve the Survey Response Rate of Patients Who Underwent Orthopaedic Surgery: A Randomized Trial.,,2019,,[],"['Orthopaedic Surgery', 'CORR Insights®']",['Survey Response Rate'],[],"[{'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0460477,,"[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'M. S. Patel, Assistant Professor, University of Pennsylvania; Staff Physician, CMC VA Medical Center, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000811'] 1511,32424499,Does physiotherapy applied in conjunction with compression brace treatment in patients with pectus carinatum have efficacy? A preliminary randomized-controlled study.,"PURPOSE Non-invasive treatment of pectus carinatum (PC) deformity includes the use of a compression brace and exercises. In this study, we aimed to examine the effect of a physiotherapy protocol applied as adjunct to compression brace treatment in patients with PC. METHODS The study included 30 male patients between 11 and 18 years of age. Patients were randomly assigned into two groups: a brace treatment only group (Group 1) and a brace and physiotherapy group (Group 2). Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction were evaluated. RESULTS Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05). Additionally, we found that patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores were significantly better in Group 2 (p < 0.05). CONCLUSION Owing to the satisfaction and additional benefits observed in the physiotherapy group, we think that a proper cardiopulmonary and musculoskeletal exercise program should be applied concurrently with brace treatment for patients with PC deformity. Nevertheless, long-term outcomes need to be clarified in future studies.",2020,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","['patients with pectus carinatum', 'patients with PC deformity', 'patients with PC', '30 male patients between 11 and 18\xa0years of age']","['physiotherapy protocol', 'compression brace and exercises', 'brace treatment only group (Group 1) and a brace and physiotherapy', 'musculoskeletal exercise program']","['Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction', 'maximum protrusion degree and lateral length values', 'patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0533754,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey. nuray.alaca@acibadem.edu.tr.'}, {'ForeName': 'İhsan', 'Initials': 'İ', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Zuhtupasa Mah. Kadıkoy, Istanbul, Turkey.'}]",Pediatric surgery international,['10.1007/s00383-020-04675-3'] 1512,31542988,"Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder.","OBJECTIVE We present a secondary analysis of data reporting differences in medication adherence, psychiatric symptom severity, and internalized stigma levels in older (age ≥ 55 years) versus younger (age < 55 years) adults with bipolar disorder (BD) and poor medication adherence. METHODS Data used for this analysis came from 184 participants in a National Institute of Mental Health-funded randomized controlled trial, comparing a customized adherence enhancement (CAE) intervention intended to promote BD medication adherence with a BD-specific educational program (EDU). At screen, study participants were ≥20% nonadherent with BD medications as measured by the Tablets Routine Questionnaire (TRQ). Psychiatric symptoms, functional status, and internalized stigma were measured using validated scales. RESULTS Older adults had significantly lower anxiety disorder comorbidity ( P < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P = .011), and self-stigma scores ( P = .001) compared to their younger counterparts. In the analyses evaluating change over time in TRQ between older and younger participants by treatment arm (ie, CAE and EDU), there was a significant finding of interaction between time, age-group, and treatment arm ( P = .007). CONCLUSIONS Older adults may be less anxious and depressed, with less self-stigma, compared to younger people with BD and poor adherence. With respect to medication adherence, older individuals in EDU appear to do less well than younger individuals over time.",2019,"RESULTS Older adults had significantly lower anxiety disorder comorbidity ( P < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P = .011), and self-stigma scores ( P = .001) compared to their younger counterparts.","['Older adults', 'older (age ≥ 55 years) versus younger (age < 55 years) adults with bipolar disorder (BD) and poor medication adherence', '184 participants in a National Institute of Mental Health-funded randomized controlled trial']",['customized adherence enhancement (CAE) intervention intended to promote BD medication adherence with a BD-specific educational program (EDU'],"['medication adherence, psychiatric symptom severity, and internalized stigma levels', 'anxiety disorder comorbidity', 'anxiety disorders), depressive symptom severity scores', 'Psychiatric symptoms, functional status, and internalized stigma', 'self-stigma scores', 'Tablets Routine Questionnaire (TRQ', 'Medication Adherence, Symptoms, and Stigma']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0027466', 'cui_str': 'National Institute of Mental Health'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",184.0,0.0551426,"RESULTS Older adults had significantly lower anxiety disorder comorbidity ( P < .01 for 1 or more anxiety disorders), depressive symptom severity scores ( P = .011), and self-stigma scores ( P = .001) compared to their younger counterparts.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Smilowitz', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Awais', 'Initials': 'A', 'LastName': 'Aftab', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Aebi', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Tatsuoka', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719874116'] 1513,32418546,Effect of the monoaminergic stabiliser (-)-OSU6162 on mental fatigue following stroke or traumatic brain injury.,"OBJECTIVE The purpose of the present study was to evaluate the efficacy and safety of (-)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from mental fatigue following stroke or traumatic brain injury (TBI). METHODS This 4 + 4 weeks double-blind randomised cross-over study included 30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least 12 months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes [Comprehensive Psychopathological Rating Scale (CPRS)], the Frenchay Activity Index (FAI), and a battery of neuropsychological tests. Safety was evaluated by recording spontaneously reported adverse events (AEs). RESULTS There were significant differences on the patients' total FAI scores (p = 0.0097), the subscale FAI outdoor scores (p = 0.0243), and on the trail making test (TMT-B) (p = 0.0325) in favour of (-)-OSU6162 treatment. Principal component analysis showed a clear overall positive treatment effect in 10 of 28 patients; those who responded best to treatment had their greatest improvements on the MFS. Reported AEs were mild or moderate in severity and did not differ between the (-)-OSU6162 and the placebo period. CONCLUSION The most obvious beneficial effects of (-)-OSU6162 were on the patients' activity level, illustrated by the improvement on the FAI scale. Moreover, a subgroup of patients showed substantial improvements on the MFS. Based on these observed therapeutic effects, in conjunction with the good tolerability of (-)-OSU6162, this compound may offer promise for treating at least part of the symptomatology in patients suffering from stroke- or TBI-induced mental fatigue.",2020,"There were significant differences on the patients' total FAI scores (p=0.0097), the subscale FAI outdoor scores (p=0.0243), and on the trail making test (TMT-B) (p=0.0325) in favour of (-)-OSU6162 treatment.","['patients suffering from stroke- or TBI-induced mental fatigue', '30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least twelve months earlier', 'mental fatigue following stroke or traumatic brain injury', 'patients suffering from mental fatigue following stroke or traumatic brain injury (TBI']",['monoaminergic stabiliser (-)-OSU6162'],"['Mental Fatigue Scale', 'Safety', 'MFS', 'subscale FAI outdoor scores', 'efficacy and safety', 'Efficacy', 'adverse events', ""patients' total FAI scores"", 'Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes (CPRS), the Frenchay Activity Index (FAI), and a battery of neuropsychological tests', 'FAI scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0966482', 'cui_str': '(-)-OSU6162'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",30.0,0.0501934,"There were significant differences on the patients' total FAI scores (p=0.0097), the subscale FAI outdoor scores (p=0.0243), and on the trail making test (TMT-B) (p=0.0325) in favour of (-)-OSU6162 treatment.","[{'ForeName': 'Marie K L', 'Initials': 'MKL', 'LastName': 'Nilsson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Carlsson', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Schuit', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rönnbäck', 'Affiliation': 'Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.22'] 1514,11934908,"Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial.","Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information.",2002,"The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689).",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.70492,"The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'McCarney', 'Affiliation': 'Academic Unit, Royal London Homoeopathic Hospital, London WC1N 3HR, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Spink', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Flint', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Haselen', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1515,25664702,Oxytocin selectively facilitates learning with social feedback and increases activity and functional connectivity in emotional memory and reward processing regions.,"In male Caucasian subjects, learning is facilitated by receipt of social compared with non-social feedback, and the neuropeptide oxytocin (OXT) facilitates this effect. In this study, we have first shown a cultural difference in that male Chinese subjects actually perform significantly worse in the same reinforcement associated learning task with social (emotional faces) compared with non-social feedback. Nevertheless, in two independent double-blind placebo (PLC) controlled between-subject design experiments we found OXT still selectively facilitated learning with social feedback. Similar to Caucasian subjects this OXT effect was strongest with feedback using female rather than male faces. One experiment performed in conjunction with functional magnetic resonance imaging showed that during the response, but not feedback phase of the task, OXT selectively increased activity in the amygdala, hippocampus, parahippocampal gyrus and putamen during the social feedback condition, and functional connectivity between the amygdala and insula and caudate. Therefore, OXT may be increasing the salience and reward value of anticipated social feedback. In the PLC group, response times and state anxiety scores during social feedback were associated with signal changes in these same regions but not in the OXT group. OXT may therefore have also facilitated learning by reducing anxiety in the social feedback condition. Overall our results provide the first evidence for cultural differences in social facilitation of learning per se, but a similar selective enhancement of learning with social feedback under OXT. This effect of OXT may be associated with enhanced responses and functional connectivity in emotional memory and reward processing regions.",2015,"In the PLC group, response times and state anxiety scores during social feedback were associated with signal changes in these same regions but not in the OXT group.","['male Chinese subjects', 'male Caucasian subjects', 'Caucasian subjects']","['placebo', 'neuropeptide oxytocin (OXT', 'Oxytocin', 'functional magnetic resonance imaging', 'OXT']","['response times and state anxiety scores', 'learning task with social (emotional faces', 'activity and functional connectivity in emotional memory and reward processing regions', 'activity in the amygdala, hippocampus, parahippocampal gyrus and putamen during the social feedback condition, and functional connectivity between the amygdala and insula and caudate']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228249', 'cui_str': 'Gyrus Hippocampi'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}]",,0.02336,"In the PLC group, response times and state anxiety scores during social feedback were associated with signal changes in these same regions but not in the OXT group.","[{'ForeName': 'Jiehui', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory for NeuroInformation of Ministry of Education, Center for Information in Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China; School of Foreign Languages, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610054, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Qiyong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': ''}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22760'] 1516,32424868,Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study.,"BACKGROUND AND AIM The aim of this study was to compare the quality and tolerability of bowel preparation using split high-doses of sennosides versus split-dose polyethylene glycol (PEG). METHODS In this prospective, randomized, and endoscopist-blinded study, 474 outpatients were included and randomly assigned to two groups: Group 1 was comprised of 237 patients receiving split high-dose (1000 mg) sennoside solutions, and group 2 included 237 patients receiving 4 L of PEG. The efficacy of the preparations was evaluated on the Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects were recorded. RESULTS The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score ≥ 6) in 89.9% of patients taking senna, and 73.8% in the PEG group (P = 0.001). The rates of vomiting in the senna and PEG groups were 12.7% and 29.5%, nausea rates were 28.7% and 43.9%, and abdominal pain rates were 70.9% and 43%, respectively (P < 0.001). Cecal intubation rates in the senna and PEG groups were 95.4% and 86.1% (P = 0.001), and the cecal intubation times were 6.73 ± 2.84 and 5.34 ± 5.98 min, respectively (P = 0.001). CONCLUSIONS Split high-dose senna is more effective than split-dose PEG in terms of bowel preparation quality and patient compliance. The patients who received senna had significantly less vomiting and nausea but significantly more abdominal pain. Thus, senna may be used as an alternative to PEG for bowel preparation.",2020,"The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score≥6) in 89.9% of patients taking senna, and 73.8% in the PEG group (p=0.001).","['474 outpatients', '237 patients receiving']","['Polyethylene glycol versus split high-dose senna for bowel preparation', 'sennosides versus split-dose polyethylene glycol (PEG', '4L of PEG', 'split high-dose (1000 mg) sennoside solutions']","['quality of colon cleansing and the ease of bowel preparation', 'vomiting and nausea', 'mean of total BBPS scores', 'abdominal pain', 'Boston Bowel Preparation Scale (BBPS), and compliance and adverse effects', 'nausea rates', 'rates of vomiting', 'quality and tolerability', 'abdominal pain rates', 'cecal intubation times', 'Cecal intubation rates']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0330722', 'cui_str': 'Cassia acutifolia'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C3489575', 'cui_str': 'sennosides, USP'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",474.0,0.0705802,"The quality of colon cleansing and the ease of bowel preparation were significantly better in the senna group; the mean of total BBPS scores was 7.35 in the senna group and 6.57 in the PEG group, cleansing was adequate (BBPS score≥6) in 89.9% of patients taking senna, and 73.8% in the PEG group (p=0.001).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Coskun', 'Affiliation': 'Department of Gastroenterology, University of Health Sciences, Diskapı Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ilhami', 'Initials': 'I', 'LastName': 'Yuksel', 'Affiliation': 'Department of Gastroenterology, Ankara Yildirim Beyazit University, School of Medicine, Ankara, Turkey.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15101'] 1517,31336289,Ten-year results of the Multicentric Italian Lung Detection trial demonstrate the safety and efficacy of biennial lung cancer screening.,"BACKGROUND The Multicentric Italian Lung Detection (MILD) trial demonstrated that prolonged low-dose computed tomography (LDCT) screening could achieve a 39% reduction in lung cancer (LC) mortality. We have here evaluated the long-term results of annual vs. biennial LDCT and the impact of screening intensity on overall and LC-specific mortality at 10 years. PATIENTS AND METHODS Between 2005 and 2018, the MILD trial prospectively randomised the 2376 screening arm participants to annual (n = 1190) or biennial (n = 1186) LDCT, for a median screening period of 6.2 years and 23,083 person-years of follow-up. The primary outcomes were 10-year overall and LC-specific mortality, and the secondary end-points were the frequency of advanced-stage and interval LCs. RESULTS The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm. Biennial screening saved 44% of follow-up LDCTs in subjects with negative baseline LDCT, and 38% of LDCTs in all participants, with no increase in the occurrence of stage II-IV or interval LCs. CONCLUSIONS The MILD trial provides original evidence that prolonged screening beyond five years with biennial LDCT can achieve an LC mortality reduction comparable to annual LDCT, in subjects with a negative baseline examination.",2019,"The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm.","['2376 screening arm participants to annual (n\xa0=\xa01190) or biennial (n\xa0=\xa01186', 'Between 2005 and 2018']","['biennial lung cancer screening', 'prolonged low-dose computed tomography (LDCT) screening', 'LDCT']","['LC-specific mortality', 'occurrence of stage II-IV or interval LCs', 'overall mortality', '10-year overall and LC-specific mortality, and the secondary end-points were the frequency of advanced-stage and interval LCs', 'LC mortality reduction', 'lung cancer (LC) mortality', 'safety and efficacy']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.365754,"The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm.","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pastorino', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: ugo.pastorino@istitutotumori.mi.it.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sestini', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sabia', 'Affiliation': 'Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeri', 'Affiliation': 'Tumor Genomics Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cantarutti', 'Affiliation': 'Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumor Genomics Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Corrao', 'Affiliation': 'Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marchianò', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.009'] 1518,26022551,A brief history of the cluster randomised trial design.,,2015,,[],[],[],[],[],[],,0.163516,,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Moberg', 'Affiliation': 'Norwegian Knowledge Centre for the Health Services, N-0130 Oslo, Norway jenny.moberg@kunnskapssenteret.no.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Norwegian Knowledge Centre for the Health Services, N-0130 Oslo, Norway McGill University, Montreal, Quebec, Canada H3A 0G4.'}]",Journal of the Royal Society of Medicine,['10.1177/0141076815582303'] 1519,32418217,The impact of a modified electronic probe tip design on patient perception of discomfort during periodontal probing using standardized probing force: A randomized controlled trial.,"AIMS This study evaluated pain associated with electronic probing comparing two commercially available probe tip designs using standardized force. MATERIAL AND METHODS Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits. In visit 1, a random arch was probed with either a ball-end (0.6 mm diameter, 408 kPa; Test) or straight (0.45 mm diameter, 726 kPa; Control) probe tip. The opposing arch was then probed using the other probe tip. Discomfort associated with each probing episode was recorded using visual analogue scale (VAS). 7 days later, tip assignments were alternated from visit 1 and VAS re-scored. VAS scores were compared by probe tip, arches and visits. RESULTS Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p = .3713). However, the straight tip was associated with decreased VAS scores in the maxilla (p = .01). Overall, VAS values did not differ by arch or study visit. Individual VAS scores showed high levels of correlation between study visits and between tips used (R 2  = .86 and 0.64, respectively, p < .0001). CONCLUSIONS Both probing approaches were associated with low levels of pain on probing. The straight tip may be perceived as more comfortable in the maxilla.",2020,"RESULTS Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).",['Twenty adult patients with slight-moderate chronic periodontitis received periodontal probing using controlled-force electronic probe at 2 visits'],['modified electronic probe tip design'],"['visual analogue scale (VAS', 'patient perception of discomfort', 'VAS scores', 'Individual VAS scores', 'Overall, VAS values']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937276', 'cui_str': 'Slight'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0339407,"RESULTS Both tips provided similar VAS scores (median 13.5 for ball-end and 14 for straight, p=0.3713).","[{'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Harrison', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Stuhr', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Shaddox', 'Affiliation': 'Division of Periodontology, University of Florida College of Dentistry, Gainesville, FL, USA.'}]",Journal of clinical periodontology,['10.1111/jcpe.13308'] 1520,31377056,Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease.,"Bardoxolone methyl attenuates inflammation by inducing nuclear factor erythroid-derived 2-related factor 2 and suppressing nuclear factor κB. The Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes (BEACON) trial was a phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial in 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease. BEACON was terminated because of safety concerns, largely related to a significant increase in early heart failure events in patients randomized to bardoxolone methyl. Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio. Herein, we present post hoc analyses characterizing the relation between the urine albumin-to-creatinine ratio and eGFR. The urine albumin-to-creatinine ratio and eGFR were assessed every four weeks through Week 12, followed by assessments every eight weeks thereafter, and 4 weeks after the last dose of bardoxolone methyl was administered. The initial increases in urine albumin-to-creatinine ratio observed in patients randomized to bardoxolone methyl were attenuated after six months. Multivariable regression analysis identified baseline eGFR and eGFR over time as the dominant factors associated with change in the urine albumin-to-creatinine ratio. Relative to placebo, bardoxolone methyl resulted in a significant decrease in albuminuria when indexed to eGFR (least-squared means: -0.035 [95% confidence interval -0.031 to -0.039]). Thus, among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl, changes in albuminuria are directly related to changes in eGFR, challenging the conventional construct that increases in albuminuria universally reflect kidney injury and denote harm.",2019,Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio.,"['Patients With Chronic Kidney Disease and Type 2 Diabetes', '2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (CKD', 'patients with type 2 diabetes and stage 4 chronic kidney disease', 'patients with type 2 diabetes mellitus and stage 4 CKD treated with']","['bardoxolone methyl', 'placebo', 'placebo, bardoxolone methyl', 'Bardoxolone methyl']","['urine albumin-to-creatinine ratio', 'albuminuria when indexed to eGFR', 'early heart failure events', 'urine albumin-to-creatinine ratio and eGFR', 'glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1100924', 'cui_str': 'methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",2185.0,0.0880907,Bardoxolone methyl resulted in increased estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'McCullough', 'Affiliation': 'Baylor Scott & White Heart and Vascular Hospital, Dallas, Texas, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Product Development, Reata Pharmaceuticals, Irving, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Packham', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates PA, San Antonio, Texas; USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Spinowitz', 'Affiliation': 'Department of Medicine, New York Presbyterian Queens, Flushing, New York, USA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, Northshore Medical University Health System-University of Chicago, Evanston, Illinois, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Warnock', 'Affiliation': 'Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, California, USA. Electronic address: gchertow@stanford.edu.'}]",Kidney international,['10.1016/j.kint.2019.04.027'] 1521,31313021,Oxidative stress and inflammatory profiles in obstructive sleep apnea: are short-term CPAP or aerobic exercise therapies effective?,"PURPOSE The effects of medium to long-term continuous positive airway pressure (CPAP) or physical activity in decreasing oxidative stress, inflammatory, and cell-free DNA markers in obstructive sleep apnea (OSA) have been explored. Here we evaluate oxidative stress markers (TBARS, AOPP, SOD), proinflammatory cytokines (TNF-α, IL-1β, IL-6, IL-8), anti-inflammatory cytokines (IL-4, IL-10), and cell-free DNA levels before and after 8-week CPAP treatment or moderate-intensity aerobic training in moderate to severe OSA. METHODS Thirty-nine patients diagnosed with OSA were randomly divided into CPAP (N = 18), with or without humidifier, and exercise groups (N = 21). Excessive daytime sleepiness and sleep quality were assessed by the Epworth Sleepiness Scale and the Pittsburgh questionnaire, respectively. Biomarkers for lipid and protein oxidation, pro and anti-inflammatory cytokines, and cell-free DNA were quantified in blood samples, before and after 8 weeks of both treatments. RESULTS After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier. We have also observed that CPAP significantly decreased the Pittsburgh scores and improved sleep efficiency and hours of sleep, while ESS scores remained unaffected. CONCLUSIONS Short-term treatment for OSA, be it CPAP therapy or moderate-intensity aerobic exercise, was not sufficient to alter either the oxidative stress and inflammatory profiles or the cell-free DNA levels of moderate to severe OSA patients. Short-term CPAP did, however, improve self-reported sleep quality.",2020,"After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier.","['Thirty-nine patients diagnosed with OSA', 'obstructive sleep apnea (OSA', 'obstructive sleep apnea']","['medium to long-term continuous positive airway pressure (CPAP) or physical activity', 'CPAP treatment or moderate-intensity aerobic training', 'CPAP']","['oxidative stress markers (TBARS, AOPP, SOD), proinflammatory cytokines (TNF-α, IL-1β, IL-6, IL-8), anti-inflammatory cytokines (IL-4, IL-10), and cell-free DNA levels', 'Excessive daytime sleepiness and sleep quality', 'AOPP and IL-17A levels', 'Pittsburgh scores and improved sleep efficiency and hours of sleep, while ESS scores', 'lipid and protein oxidation, pro and anti-inflammatory cytokines, and cell-free DNA', 'Oxidative stress and inflammatory profiles', 'Epworth Sleepiness Scale and the Pittsburgh questionnaire', 'levels of cell-free DNA, oxidative stress, and inflammation markers', 'self-reported sleep quality']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C4289789', 'cui_str': 'Cell-Free Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",39.0,0.0166835,"After 8 weeks of either CPAP or exercise, no significant differences were observed in the levels of cell-free DNA, oxidative stress, and inflammation markers, except for an increase in AOPP and IL-17A levels in individuals who went through CPAP, which were higher when the CPAP device was used without the humidifier.","[{'ForeName': 'Ytalo Gonçalves', 'Initials': 'YG', 'LastName': 'Borges', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Luis Henrique Ceia', 'Initials': 'LHC', 'LastName': 'Cipriano', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Aires', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}, {'ForeName': 'Paulo Vinicios Camuzi', 'Initials': 'PVC', 'LastName': 'Zovico', 'Affiliation': 'Physical Education Graduation Program, Physical Education and Sports Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-090, Brazil.'}, {'ForeName': 'Fabiana Vasconcelos', 'Initials': 'FV', 'LastName': 'Campos', 'Affiliation': 'Biochemistry Graduation Program, Physiological Sciences Department, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-090, Brazil.'}, {'ForeName': 'Maria Teresa Martins', 'Initials': 'MTM', 'LastName': 'de Araújo', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil. maraujo.27@hotmail.com.'}, {'ForeName': 'Sonia Alves', 'Initials': 'SA', 'LastName': 'Gouvea', 'Affiliation': 'Physiological Sciences Graduation Program, Health Sciences Center, Federal University of Espírito Santo, Av. Marechal Campos 1468, Maruípe, Vitória, ES, 29040-900, Brazil.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01898-0'] 1522,31318033,"Moderate Postmeal Walking Has No Beneficial Effects Over Resting on Postprandial Lipemia, Glycemia, Insulinemia, and Selected Oxidative and Inflammatory Parameters in Older Adults with a Cardiovascular Disease Risk Phenotype: A Randomized Crossover Trial.","BACKGROUND Research suggests that postprandial events, as risk factors for cardiovascular diseases (CVDs), are influenced by meal composition and exercise. OBJECTIVES We investigated the effect of walking versus rest on postprandial metabolic, inflammatory, and oxidative events following the consumption of test meals reflecting 2 different dietary patterns in older adults with an increased CVD risk. METHODS A randomized crossover trial was conducted in 26 men and women (aged 70 ± 5 y; BMI 30.3 ± 2.3 kg/m2). Each adult participated in 4 treatments combining 1 of 2 iso-energetic (4300 kJ) meals [Western diet high-fat meal (WD): total fat, 59.4 g; saturated fatty acids, 32.0 g, dietary fiber, 4.2 g; or Mediterranean-type diet meal (MD): total fat, 40.1 g; saturated fatty acids, 5.1 g; dietary fiber, 14.5 g] with 30 min walking (4.6 ± 0.1 km/h) or rest. Primary (serum triglycerides) and secondary [serum nonesterified fatty acids (NEFAs); parameters of glucose metabolism, inflammation, endothelial activation, oxidation; blood pressure/heart rate] outcomes were measured at fasting and 1.5, 3.0, and 4.5 h postprandially. Data were analyzed by linear mixed models. RESULTS Triglycerides were higher after the WD than after the MD [AUC in mmol/L × min: Western diet high-fat meal plus postprandial walking (WD-W), 218 ± 15.2; Western diet high-fat meal plus postprandial resting (WD-R), 207 ± 12.6; Mediterranean-type diet meal plus postprandial walking (MD-W), 139 ± 9.83; Mediterranean-type diet meal plus postprandial resting (MD-R), 149 ± 8.15; P  < 0.001]. No meal or activity effect was observed for NEFAs based on AUC data (WD-W, -43.5 ± 7.08; WD-R, -49.2 ± 6.94; MD-W, -48.0 ± 11.6; MD-R, -67.6 ± 7.58). Plasma glucose was higher after the MD than after the WD (WD-W, 222 ± 34.9; WD-R, 177 ± 32.8; MD-W, 314 ± 44.4; MD-R, 275 ± 57.8; P  < 0.001), as was serum insulin (AUC in nmol/L × min: WD-W, 82.0 ± 10.3; WD-R, 88.6 ± 12.8; MD-W, 129 ± 14.7; MD-R, 138 ± 20.5; P < 0.001). Plasma IL-6 was higher after walking than after resting (AUC in pg/mL × min: WD-W, 72.0 ± 34.0; WD-R, 14.3 ± 38.8; MD-W, 70.8 ± 39.4; MD-R, 5.60 ± 26.0; P < 0.05). Plasma vitamin C was higher after the MD than after the WD (P < 0.001) and after walking than after resting (P < 0.05; AUC in mg/L × min: WD-W, -305 ± 59.6; WD-R, -396 ± 84.0; MD-W, 113 ± 56.4; MD-R, -44.5 ± 48.1). We observed no meal or activity effects on parameters of oxidation and endothelial adhesion molecules. Our data revealed no significant meal × activity effects on all outcomes. CONCLUSIONS In older adults with an increased CVD risk, the MD was associated with superior effects on several postprandial parameters (e.g., triglycerides), in comparison to the WD. Data revealed no relevant differences regarding the effects of postmeal walking and resting. None of the 4 treatments can be rated as superior regarding their acute effects on the shown postprandial metabolic, oxidative, and inflammatory parameters. The trial was registered at German Clinical Trials Register (DRKS; http://www.germanctr.de and http://www.drks.de) under identifier DRKS00012409.",2019,Plasma vitamin C was higher after the MD than after the WD (P ,"['older adults with an increased CVD risk', '26 men and women (aged 70\xa0±\xa05', 'Older Adults with a Cardiovascular Disease Risk Phenotype']","['Western diet high-fat meal plus postprandial walking (WD-W), 218\xa0±\xa015.2; Western diet high-fat meal plus postprandial resting (WD-R), 207\xa0±\xa012.6; Mediterranean-type diet meal plus postprandial walking (MD-W), 139\xa0±\xa09.83; Mediterranean-type diet meal plus postprandial resting (MD-R), 149\xa0±\xa08.15', '2 iso-energetic (4300 kJ) meals [Western diet high-fat meal (WD): total fat, 59.4 g; saturated fatty acids, 32.0 g, dietary fiber, 4.2 g; or Mediterranean-type diet meal (MD): total fat, 40.1 g; saturated fatty acids, 5.1 g; dietary fiber, 14.5 g] with 30 min walking (4.6\xa0±\xa00.1 km/h) or rest']","['Postprandial Lipemia, Glycemia, Insulinemia, and Selected Oxidative and Inflammatory Parameters', 'Primary (serum triglycerides) and secondary [serum nonesterified fatty acids (NEFAs); parameters of glucose metabolism, inflammation, endothelial activation, oxidation', 'postprandial metabolic, oxidative, and inflammatory parameters', 'serum insulin (AUC', 'Plasma IL-6', 'Triglycerides', 'No meal or activity effect', 'postprandial metabolic, inflammatory, and oxidative events', 'Plasma glucose', 'blood pressure/heart rate] outcomes', 'Plasma vitamin C', 'oxidation and endothelial adhesion molecules']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C3849996', 'cui_str': 'Western Dietary Pattern'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1706412', 'cui_str': 'Lipemia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",,0.0643944,Plasma vitamin C was higher after the MD than after the WD (P ,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Diekmann', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Huber', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Preuß', 'Affiliation': 'Human Resources Development and Career, Healthy Campus Bonn, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preuß', 'Affiliation': 'University Sports, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Predel', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Central Laboratory, Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Informatics and Epidemiology, Institute of Medical Biometry, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Egert', 'Affiliation': 'Nutritional Physiology, Institute of Nutrition and Food Sciences, University of Bonn, Bonn, Germany.'}]",The Journal of nutrition,['10.1093/jn/nxz148'] 1523,31843844,Advance care planning for vulnerable older adults within an Accountable Care Organization: study protocol for the IMPACT randomised controlled trial.,"INTRODUCTION Patients with multimorbidity plus additional impairments (eg, mobility limitations, disability, cognitive impairments or frailty) are at the highest risk for poor healthcare outcomes. Advanced care planning (ACP) provides patients and their surrogates the opportunity to discuss their goals, values and priorities for healthcare-particularly in the context of end-of-life care. ACP discussions promote more person-centred care; however, it is currently underused. There is a tremendous need for systematic, scalable approaches to individualised ACP that promotes patient and family engagement. Here we describe the study protocol for a randomised effectiveness trial of a nurse navigator and informatics intervention designed to improve the documentation and quality of ACP discussions. METHODS AND ANALYSIS This is a randomised, pragmatic, effectiveness trial; patients aged 65 years and older who have multimorbidity plus impairments in either physical function (eg, mobility limitations or disability) or cognition, and/or frailty within an affiliated Accountable Care Organization were eligible. The electronic health record was used to develop an automatic prescreening system for eligible patients (n=765) and participants were randomised in a 1:1 ratio to either the nurse navigator-led ACP pathway or usual care. Our primary outcomes are documentation of ACP discussions within the EHR along with the quality of ACP discussions. Secondary outcomes include a broad range of ACP actions (eg, usage of ACP billing codes, choosing a surrogate decision-maker and advance directive documentation). Outcomes will be measured over 12 months of follow-up. ETHICS AND DISSEMINATION This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards. The results of this study will inform a scalable solution to ACP discussions throughout our healthcare system and statewide. TRIALS REGISTRATION NUMBER NCT03609658.",2019,The electronic health record was used to develop an automatic prescreening system for eligible patients (n=765) and participants were randomised in a 1:1 ratio to either the nurse navigator-led ACP pathway or usual care.,"['patients aged 65 years and older who have multimorbidity plus impairments in either physical function (eg, mobility limitations or disability) or cognition, and/or frailty within an affiliated Accountable Care Organization were eligible', 'vulnerable older adults', 'eligible patients (n=765) and participants']","['Advance care planning', 'nurse navigator-led ACP pathway or usual care', 'ACP discussions', 'Advanced care planning (ACP', 'nurse navigator and informatics intervention']","['documentation of ACP discussions', 'broad range of ACP actions (eg, usage of ACP billing codes, choosing a surrogate decision-maker and advance directive documentation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organizations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]",765.0,0.129991,The electronic health record was used to develop an automatic prescreening system for eligible patients (n=765) and participants were randomised in a 1:1 ratio to either the nurse navigator-led ACP pathway or usual care.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gabbard', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology & Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA jgabbard@wakehealth.edu.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Callahan', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology & Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Dharod', 'Affiliation': 'Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Foley', 'Affiliation': 'Department of Implementation Science, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Ferris', 'Affiliation': 'Department of Internal Medicine,Section of Gerontology & Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Moses', 'Affiliation': 'Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Grey', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology & Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology & Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",BMJ open,['10.1136/bmjopen-2019-032732'] 1524,31144282,Communicating a Prognosis: a Randomized Trial of Survival Rate Language.,,2019,,[],[],[],[],[],[],,0.121896,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Silver', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Broomell', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Davis', 'Affiliation': 'Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Krishnamurti', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA. tamark@pitt.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05056-w'] 1525,31544367,Computed Tomography Pulmonary Vascular Volume Ratio Can Be Used to Evaluate the Effectiveness of Pulmonary Angioplasty in Peripheral Pulmonary Artery Stenosis.,"OBJECTIVE To explore whether computed tomography (CT) pulmonary vascular volume ratio can be used to evaluate the effectiveness of pulmonary artery angioplasty in patients with peripheral pulmonary artery stenosis. MATERIALS AND METHODS Changes in CT pulmonary vascular volume ratio between serial cardiothoracic CT examinations were calculated in 38 patients. Fifteen patients underwent interim pulmonary artery angioplasty (group 1), while 23 did not (group 2). According to the effectiveness of pulmonary artery angioplasty, patients in group 1 were further divided into group 1A (improved or aggravated) and group 1B (ineffective). Changes in the pulmonary vascular volume percentages among the three groups (group 1A, group 1B, and group 2) on serial CT examinations were compared. RESULTS Pulmonary artery angioplasty on serial CT examinations was successful in seven patients, ineffective in seven patients, and aggravated in one patient. As a result, eight patients were included in group 1A and seven were included in group 1B. Changes in the CT pulmonary vascular volume percentages in group 1A were statistically significantly greater than those in group 1B (11.6 ± 5.6% vs. 2.7 ± 1.6%, p < 0.003) and group 2 (11.6 ± 5.6% vs. 1.9 ± 1.4%, p < 0.002), while no statistically significant difference was found between group 1B and group 2 (2.7 ± 1.6% vs. 1.9 ± 1.4%, p > 0.1). CONCLUSION CT pulmonary vascular volume ratio can be used to evaluate the effectiveness of pulmonary artery angioplasty in patients with peripheral pulmonary artery stenosis.",2019,"CONCLUSION CT pulmonary vascular volume ratio can be used to evaluate the effectiveness of pulmonary artery angioplasty in patients with peripheral pulmonary artery stenosis.","['patients with peripheral pulmonary artery stenosis', 'Fifteen patients underwent', '38 patients', 'Peripheral Pulmonary Artery Stenosis']","['interim pulmonary artery angioplasty', 'computed tomography (CT) pulmonary vascular volume ratio', 'pulmonary artery angioplasty']","['CT pulmonary vascular volume ratio between serial cardiothoracic CT examinations', 'CT pulmonary vascular volume percentages', 'pulmonary vascular volume percentages', 'serial CT examinations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0345030', 'cui_str': 'Peripheral pulmonary artery stenosis (disorder)'}]","[{'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]",,0.0150492,"CONCLUSION CT pulmonary vascular volume ratio can be used to evaluate the effectiveness of pulmonary artery angioplasty in patients with peripheral pulmonary artery stenosis.","[{'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Goo', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. ghw68@hanmail.net.'}]",Korean journal of radiology,['10.3348/kjr.2019.0286'] 1526,31445198,SAPPHIRE: a randomised phase II study of planned discontinuation or continuous treatment of oxaliplatin after six cycles of modified FOLFOX6 plus panitumumab in patients with colorectal cancer.,"BACKGROUND Fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (FOLFOX) plus panitumumab therapy is a commonly used first-line chemotherapy for metastatic colorectal cancer (mCRC). However, the long-term administration of oxaliplatin is associated with peripheral neuropathy (PN). We investigated whether the planned discontinuation of oxaliplatin after FOLFOX plus panitumumab therapy can maintain efficacy and reduce PN incidence. PATIENTS AND METHODS Chemotherapy-naive patients with RAS wild-type mCRC, aged ≥20 years, were enrolled and received six cycles of modified FOLFOX6 (mFOLFOX6) plus panitumumab as induction therapy. Patients who completed induction therapy without progression were randomised to mFOLFOX6 plus panitumumab (group A) or to 5-FU/LV plus panitumumab (group B). The primary end-point was the progression-free survival (PFS) rate at 9 months after randomisation. The secondary end-points were PFS, overall survival (OS), time to treatment failure (TTF), response rate (RR) and safety. RESULTS In total, 164 patients were enrolled; of whom, 113 patients were then randomised (group A, n = 56; group B, n = 57). The median follow-up after randomisation was 19.6 months. The PFS rates at 9 months and median PFS were 46.4% (80% confidence interval [CI], 38.1-54.9) and 9.1 months (95% CI, 8.6-11.1) in group A, compared with 47.4% (80% CI, 39.1-55.8) and 9.3 months (95% CI, 6.0-13.0) in group B, respectively. RR, OS and TTF were also similar in both groups. Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%). CONCLUSION Planned discontinuation of oxaliplatin after six cycles of mFOLFOX6 plus panitumumab is a potential treatment option in patients with mCRC, achieving similar efficacy while reducing oxaliplatin-associated PN compared with mFOLFOX6 plus panitumumab. TRIAL REGISTRATION NUMBER NCT02337946.",2019,"Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%). ","['metastatic colorectal cancer (mCRC', 'Chemotherapy-naive patients with RAS wild-type mCRC, aged ≥20 years', 'Patients who completed induction therapy without progression', '164 patients were enrolled; of whom, 113 patients', 'patients with colorectal cancer', 'patients with mCRC']","['5-FU/LV plus panitumumab', 'modified FOLFOX6 (mFOLFOX6) plus panitumumab', 'oxaliplatin after FOLFOX plus panitumumab therapy', 'Fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (FOLFOX) plus panitumumab therapy', 'oxaliplatin', 'modified FOLFOX6 plus panitumumab', 'mFOLFOX6 plus panitumumab']","['median PFS', 'RR, OS\xa0and TTF', 'progression-free survival (PFS) rate', 'PFS rates', 'Grade ≥2\xa0PN incidence', 'PFS, overall survival (OS), time to treatment failure (TTF), response rate (RR)\xa0and safety']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",164.0,0.301007,"Grade ≥2 PN incidence was lower in group B (9.3%) than in group A (35.7%). ","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Department of Surgery, Fukui-ken Saiseikai Hospital, 7-1 Funabashi, Wadanaka-cho, Fukui City, Fukui, 918-8503, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Multidisciplinary Treatment Cancer Center, Aizawa Hospital, 2-5-1 Honjou, Matsumoto City, Nagano, 390-8510, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': ""Department of Gastroenterological Surgery, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama City, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe City, Hyogo, 655-0031, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijounomachi, Kokurakita-ku, Kitakyushu City, Fukuoka, 802-8517, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, 2 -1-14 Hoenzaka, Chuo-ku, Osaka City, Osaka, 540-0006, Japan; Department of Surgery, Kansai Rosai Hospital, 3 Chome-1-69 Inabaso, Amagasaki City, Hyogo, 660-8511, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Minagawa', 'Affiliation': 'Department of Surgery 1, The University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu City, Fukuoka, 807-8555, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noura', 'Affiliation': 'Department of Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai City, Osaka, 591-8025, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, 13-9 Rokutanji-cho, Nishinomiya City, Hyogo, 662-0918, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy Surgery, Tokyo Women's Medical University Yachiyo Medical Center, 477-96 Owada Shinden, Yachiyo City, Chiba, 276-8524, Japan.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Touyama', 'Affiliation': 'Department of Surgery, Nakagami Hospital, 610 Noborikawa, Okinawa City, Okinawa, 904-2195, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Hospital, 1-1 Yanagido, Gifu City, Gifu, 501-1194, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Multidisciplinary Treatment Cancer Center, Kurume University Hospital, 67 Asahimachi, Kurume City, Fukuoka, 830-0011, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo, 650-0047, Japan; Cancer Treatment Center, Kansai Medical University Hospital, 2-3-1 Shinmachi, Hirakata City, Osaka, 573-1191, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kurosawa', 'Affiliation': 'Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, 2-1-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8668, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, 2-1-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8668, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mishima', 'Affiliation': 'Cancer Center, Aichi Medical University, 1-1 Yazakokarimata, Nagakute City, Aichi, 480-1195, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': ""Hospital Director's Office, Tokai Central Hospital, 4-6-2 Sohara Higashijima-cho, Kakamigahara City, Gifu, 504-8601, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Oba', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8654, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijounomachi, Kokurakita-ku, Kitakyushu City, Fukuoka, 802-8517, Japan. Electronic address: n.nagata@kitakyu-hp.or.jp.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.006'] 1527,30260740,Eicosapentaenoic Acid-Rich Fish Oil Supplementation Inhibits the Decrease in Concentric Work Output and Muscle Swelling of the Elbow Flexors.,"OBJECTIVE The aim of this study was to test the hypothesis that 8-week eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation improves peripheral muscle performance by concentric contractions (CONs) of elbow flexors in humans. METHODS Sixteen healthy men were randomly administered with EPA and DHA supplement (EPA, n = 8) or placebo (PL, n = 8) by a double-blind method. The EPA group was administered EPA-rich fish oil, containing 600 mg EPA and 260 mg DHA per day for 8 weeks. The subjects performed 5 sets of 6 maximal CONs of elbow flexors. The work output and peak torque were assessed during exercise. Changes in the maximal voluntary isometric contraction torque, range of motion (ROM), upper arm circumference, muscle fatigue by rating of perceived exertion, transverse relaxation time, cross-sectional area (CSA), and lactate in blood were also assessed before, immediately after, and 1 day after exercise. RESULTS The work output during CONs in the EPA group was greater than that in the placebo group at the fifth set (EPA group; 94.0 ± 11.7%, placebo group; 82.5 ± 11.7%, p < 0.05). In addition, ROM in the EPA group was significantly greater than that in the placebo group immediately after exercise (p < 0.05). The increase of CSA in the EPA group was significantly smaller than that in the placebo group immediately after exercise (p < 0.05). CONCLUSIONS The present study suggests that the reduction of muscle work output caused by 30 CONs can be attenuated by an 8-week EPA and DHA supplementation. In addition, EPA and DHA supplementation can cause inhibition for reduction of ROM and increase of CSA after CONs.",2019,"Changes in the maximal voluntary isometric contraction torque, range of motion (ROM), upper arm circumference, muscle fatigue by rating of perceived exertion, transverse relaxation time, cross-sectional area (CSA), and lactate in blood were also assessed before, immediately after, and 1 day after exercise. ","['elbow flexors in humans', 'Sixteen healthy men']","['EPA and DHA supplementation', 'Eicosapentaenoic Acid-Rich Fish Oil Supplementation', 'placebo', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'EPA and DHA supplement (EPA, n\u2009=\u20098) or placebo (PL, n\u2009=\u20098) by a double-blind method']","['work output and peak torque', 'peripheral muscle performance', 'work output during CONs', 'maximal voluntary isometric contraction torque, range of motion (ROM), upper arm circumference, muscle fatigue by rating of perceived exertion, transverse relaxation time, cross-sectional area (CSA), and lactate in blood', 'Concentric Work Output and Muscle Swelling of the Elbow Flexors', 'CSA']","[{'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}]",16.0,0.204198,"Changes in the maximal voluntary isometric contraction torque, range of motion (ROM), upper arm circumference, muscle fatigue by rating of perceived exertion, transverse relaxation time, cross-sectional area (CSA), and lactate in blood were also assessed before, immediately after, and 1 day after exercise. ","[{'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'a Faculty of Bioscience and Applied Chemistry , Hosei University , Tokyo , Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yanagimoto', 'Affiliation': 'c Human Life Science R&D Center , Nippon Suisan Kaisha, Ltd , Tokyo , Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'b Sports Research Center , Hosei University , Tokyo , Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'd Faculty of Modern Life , Teikyo Heisei University , Tokyo , Japan.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1470042'] 1528,25478102,Antipsychotic Polypharmacy in Clozapine Resistant Schizophrenia: A Randomized Controlled Trial of Tapering Antipsychotic Co-treatment.,"There is a considerable disparity between clinical practice and recommendations based on meta-analyses of antipsychotic polypharmacy in clozapine resistant schizophrenia. For this reason, we investigated the clinical response to reducing the use olanzapine that had been previously added on clozapine treatment among seriously ill hospitalized patients. In a randomized controlled trial with crossover design, we studied volunteer patients (N=15) who had olanzapine added on to clozapine in a state mental hospital. Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures. Polypharmacy is widely used in treating schizophrenia, and usually, add-on medications are started because of worsening of the clinical state. A major confounding feature of these add-ons is whether observed improvements are caused by the medication or explained by the natural fluctuating course of the disorder. The present study, in spite of its small size, indicates the necessity of reconsidering the value of polypharmacy in treating schizophrenia.",2012,"Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures.","['seriously ill hospitalized patients', 'Resistant Schizophrenia', 'in a state mental hospital', 'volunteer patients (N=15) who had']","['Clozapine monotherapy', 'olanzapine', 'Clozapine', 'clozapine', 'Tapering Antipsychotic Co-treatment', 'clozapine-olanzapine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0432168,"Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures.","[{'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Repo-Tiihonen', 'Affiliation': 'Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital , Kuopio ;'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Hallikainen', 'Affiliation': 'Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital , Kuopio ;'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Kivistö', 'Affiliation': 'Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital , Kuopio ;'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Tiihonen', 'Affiliation': ''}]",Mental illness,['10.4081/mi.2012.e1'] 1529,25478114,The effects of music relaxation and muscle relaxation techniques on sleep quality and emotional measures among individuals with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD), an anxiety disorder with lifetime prevalence of 7.8%, is characterized by symptoms that develop following exposure to traumatic life events and that cause an immediate experience of intense fear, helplessness or horror. PTSD is marked by recurrent nightmares typified by the recall of intrusive experiences and by extended disturbance throughout sleep. Individuals with PTSD respond poorly to drug treatments for insomnia. The disadvantages of drug treatment for insomnia underline the importance of non-pharmacological alternatives. Thus, the present study had three aims: first, to compare the efficiency of two relaxation techniques (muscular relaxation and progressive music relaxation) in alleviating insomnia among individuals with PTSD using both objective and subjective measures of sleep quality; second, to examine whether these two techniques have different effects on psychological indicators of PTSD, such as depression and anxiety; and finally, to examine how initial PTSD symptom severity and baseline emotional measures are related to the efficiency of these two relaxation methods. Thirteen PTSD patients with no other major psychiatric or neurological disorders participated in the study. The study comprised one seven-day running-in, no-treatment period, followed by two seven-day experimental periods. The treatments constituted either music relaxation or muscle relaxation techniques at desired bedtime. These treatments were randomly assigned. During each of these three experimental periods, subjects' sleep was continuously monitored with a wrist actigraph (Ambulatory Monitoring, Inc.), and subjects were asked to fill out several questionnaires concerned with a wide spectrum of issues, such as sleep, depression, and anxiety. Analyses revealed a significant increase in objective and subjective sleep efficiency and a significant reduction in depression level following music relaxation. Moreover, following music relaxation, a highly significant negative correlation was found between improvement in objective sleep efficiency and reduction in depression scale. The study's findings provide evidence that music relaxation at bedtime can be used as treatment for insomnia among individuals with PTSD.",2012,"Moreover, following music relaxation, a highly significant negative correlation was found between improvement in objective sleep efficiency and reduction in depression scale.","['Thirteen PTSD patients with no other major psychiatric or neurological disorders participated in the study', 'individuals with PTSD', 'Individuals with PTSD respond poorly to drug treatments for insomnia', 'individuals with posttraumatic stress disorder']","['relaxation techniques (muscular relaxation and progressive music relaxation', 'music relaxation or muscle relaxation techniques', 'music relaxation and muscle relaxation techniques']","['Posttraumatic stress disorder (PTSD', 'objective sleep efficiency', 'depression scale', 'depression level', 'sleep quality and emotional measures', 'objective and subjective sleep efficiency']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205169', 'cui_str': 'Bad (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation Technics'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",13.0,0.0114312,"Moreover, following music relaxation, a highly significant negative correlation was found between improvement in objective sleep efficiency and reduction in depression scale.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Blanaru', 'Affiliation': 'Psychiatric Department, Haemek Medical Center, Afula;'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Bloch', 'Affiliation': 'Psychiatric Department, Haemek Medical Center, Afula;'}, {'ForeName': 'Limor', 'Initials': 'L', 'LastName': 'Vadas', 'Affiliation': 'Department of Psychology and The Center for Psychobiological Research, The Max Stern Academic College of Emek Yezreel, Israel.'}, {'ForeName': 'Zahi', 'Initials': 'Z', 'LastName': 'Arnon', 'Affiliation': 'Department of Psychology and The Center for Psychobiological Research, The Max Stern Academic College of Emek Yezreel, Israel.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Ziv', 'Affiliation': 'Department of Psychology and The Center for Psychobiological Research, The Max Stern Academic College of Emek Yezreel, Israel.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Kremer', 'Affiliation': 'Psychiatric Department, Haemek Medical Center, Afula;'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Haimov', 'Affiliation': 'Department of Psychology and The Center for Psychobiological Research, The Max Stern Academic College of Emek Yezreel, Israel.'}]",Mental illness,['10.4081/mi.2012.e13'] 1530,25478119,Routine general practice care for panic disorder within the lifestyle approach to managing panic study.,"UNLABELLED Routine general practice (GP) care is rarely comprehensively described in clinical trials. This paper examines routine GP care within the lifestyle approach to managing panic (LAMP) study. The aim of this paper is to describe/discuss routine GP care for panic disorder (PD) patients within both study arms in the LAMP study. An unblinded pragmatic randomised controlled trial in 15 East of England GP practices (2 primary care trusts). Participants met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for PD with/without agoraphobia. Follow-up measures recorded at 20 weeks/10 months following randomisation. Control arm, unrestricted routine GP care (practice appointments, referrals and prescriptions). Trial arm, occupational therapy-led lifestyle treatment comprising lifestyle review of fluid intake, diet pattern, exercise, caffeine, alcohol and nicotine. PRIMARY OUTCOME MEASURE beck anxiety inventory. At baseline, participants attended 2-3 times more GP appointments than population average, reducing at 10 months to 1.6 times population average for routine GP care and 0.97 population average for lifestyle arm. At 10 months, 33% fewer referrals (6 referrals; 0 mental health) than at baseline (9 referrals; 2 mental health) were made for lifestyle arm patients compared with 42% increase (from 12 referrals; 8 mental health at baseline to 17 referrals; 7 mental health) in GP care arm. Selective serotonin reuptake inhibitors were prescribed most often. Benzodiazepines and beta-blockers were prescribed more often than tricyclic against current clinical guidelines. In conclusion, we found that PD patients at baseline were high healthcare resource users. Treatment in both study arms reduced resource use. Routine GP care requires further review for this patient group.",2012,"At baseline, participants attended 2-3 times more GP appointments than population average, reducing at 10 months to 1.6 times population average for routine GP care and 0.97 population average for lifestyle arm.","['panic disorder (PD) patients within both study arms in the LAMP study', '15 East of England GP practices (2 primary care trusts', 'Participants met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for PD with/without agoraphobia']","['Benzodiazepines and beta-blockers', 'routine GP care', 'occupational therapy-led lifestyle treatment comprising lifestyle review of fluid intake, diet pattern, exercise, caffeine, alcohol and nicotine']",['beck anxiety inventory'],"[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}]",,0.0291916,"At baseline, participants attended 2-3 times more GP appointments than population average, reducing at 10 months to 1.6 times population average for routine GP care and 0.97 population average for lifestyle arm.","[{'ForeName': 'Rodney A', 'Initials': 'RA', 'LastName': 'Lambert', 'Affiliation': 'Faculty of Medicine and Health, University of East Anglia, Norwich, UK.'}]",Mental illness,['10.4081/mi.2012.e18'] 1531,25478136,Decreased mental health care utilization following a psychosocial intervention in caregivers of hematopoietic stem cell transplant patients.,"Caregivers are known to experience increased morbidity when compared to noncaregivers. Does an intervention targeting caregiver distress affect their health care utilization? One hundred forty-eight caregivers of allogeneic hematopoietic stem cell transplant patients were randomized to treatment as usual (TAU) or a psychoeducation, paced respiration, and relaxation (PEPRR) intervention. Assessments of caregivers' service utilization were collected at baseline and 1, 3, and 6 months post-transplant. During the first 30 days after patient transplant, caregiver medical and mental health professional service use decreased while support group attendance peaked. Mixed model regressions showed a significant decrease in mental health service use by the PEPRR group (P=0.001). At six months caregivers in TAU had predicted marginal probabilities of mental health services utilization over 10 times as high as caregivers in PEPRR (18.1% vs 1.5%). Groups failed to differ in medical service (P=0.861) or support group (P=0.067) use. We can conclude that participation in PEPRR compared to TAU was associated with reduced mental health service utilization. Caregiver psychosocial support services are critical to improve caregiver outcomes.",2014,Mixed model regressions showed a significant decrease in mental health service use by the PEPRR group (P=0.001).,"['One hundred forty-eight caregivers of allogeneic hematopoietic stem cell transplant patients', 'caregivers of hematopoietic stem cell transplant patients']","['usual (TAU) or a psychoeducation, paced respiration, and relaxation (PEPRR) intervention', 'psychosocial intervention']","[""caregivers' service utilization"", 'caregiver medical and mental health professional service use', 'mental health care utilization', 'mental health service', 'marginal probabilities of mental health services utilization', 'mental health service utilization', 'morbidity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",148.0,0.0688152,Mixed model regressions showed a significant decrease in mental health service use by the PEPRR group (P=0.001).,"[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Ouseph', 'Affiliation': 'Duke University , Durham, NC ; Anschutz Medical Campus, University of Colorado , Denver, CO.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Croy', 'Affiliation': 'Anschutz Medical Campus, University of Colorado , Denver, CO.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Natvig', 'Affiliation': 'Anschutz Medical Campus, University of Colorado , Denver, CO.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Simoneau', 'Affiliation': 'Anschutz Medical Campus, University of Colorado , Denver, CO.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Laudenslager', 'Affiliation': 'Anschutz Medical Campus, University of Colorado , Denver, CO.'}]",Mental illness,['10.4081/mi.2014.5120'] 1532,32425160,Longitudinal assessment of carotid plaque texture in three-dimensional ultrasound images based on semi-supervised graph-based dimensionality reduction and feature selection.,"With continuous development of therapeutic options for atherosclerosis, image-based biomarkers sensitive to the effect of new interventions are required to be developed for cost-effective clinical evaluation. Although 3D ultrasound measurement of total plaque volume (TPV) showed the efficacy of high-dose statin, more sensitive biomarkers are needed to establish the efficacy of dietary supplements expected to confer a smaller beneficial effect. This study involved 171 subjects who participated in a one-year placebo-controlled trial evaluating the effect of pomegranate. A framework involving a feature selection technique known as discriminative feature selection (DFS) and a semi-supervised graph-based regression (SSGBR) technique was proposed for sensitive detection of plaque textural changes over the trial. 376 textual features of plaques were extracted from 3D ultrasound images acquired at baseline and a follow-up session. A scalar biomarker for each subject were generated by SSGBR based on prominent textural features selected by DFS. The ability of this biomarker for discriminating pomegranate from placebo subjects was quantified by the p-values obtained in Mann-Whitney U test. The discriminative power of SSGBR was compared with global and local dimensionality reduction techniques, including linear discriminant analysis (LDA), maximum margin criterion (MMC) and Laplacian Eigenmap (LE). Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level. As compared with ΔTPV, SSGBR reduced the sample size required to establish a significant difference by a factor of 60. The application of this framework will substantially reduce the cost incurred in clinical trials.",2020,Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level.,['171 subjects who participated in a one-year'],['placebo'],"['linear discriminant analysis (LDA), maximum margin criterion (MMC) and Laplacian Eigenmap (LE', 'normalized LE']","[{'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012630', 'cui_str': 'Discriminant Analysis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",376.0,0.0386513,Only SSGBR (p=4.12×10 -6 ) and normalized LE (p=0.002) detected a difference between the two groups at the 5% significance level.,"[{'ForeName': 'Mingquan', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Weifu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Mathematics, Sun Yat-sen University, Guangzhou, China; Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Arna', 'Initials': 'A', 'LastName': 'van Engelen', 'Affiliation': 'Biomedical Imaging Group Rotterdam, Departments of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'de Bruijne', 'Affiliation': 'Biomedical Imaging Group Rotterdam, Departments of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands; Machine Learning Section, Department of Computer Science, University of Copenhagen, Denmark.'}, {'ForeName': 'M Reza', 'Initials': 'MR', 'LastName': 'Azarpazhooh', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada; Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': 'Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chiu', 'Affiliation': 'Department of Electrical Engineering, City University of Hong Kong, Hong Kong, China. Electronic address: bcychiu@cityu.edu.hk.'}]",Computers in biology and medicine,['10.1016/j.compbiomed.2019.103586'] 1533,25341445,How much do you need: a randomised experiment of whether readers can understand the key messages from summaries of Cochrane Reviews without reading the full review.,"OBJECTIVE We explored whether readers can understand key messages without having to read the full review, and if there were differences in understanding between various types of summary. DESIGN A randomised experiment of review summaries which compared understanding of a key outcome. PARTICIPANTS Members of university staff (n = 36). SETTING Universities on the island of Ireland. METHOD The Cochrane Review chosen examines the health impacts of the use of electric fans during heat waves. Participants were asked their expectation of the effect these would have on mortality. They were then randomly assigned a summary of the review (i.e. abstract, plain language summary, podcast or podcast transcription) and asked to spend a short time reading/listening to the summary. After this they were again asked about the effects of electric fans on mortality and to indicate if they would want to read the full Review. MAIN OUTCOME MEASURE Correct identification of a key review outcome. RESULTS Just over half (53%) of the participants identified its key message on mortality after engaging with their summary. The figures were 33% for the abstract group, 50% for both the plain language and transcript groups and 78% for the podcast group. CONCLUSIONS The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries. These findings should be explored further using a larger sample size and with other reviews.",2014,The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries.,"['Members of university staff (n\u2009=\u200936', 'Universities on the island of Ireland']","['plain language summary, podcast or podcast transcription) and asked to spend a short time reading/listening to the summary']","['mortality', 'knowledge transfer']","[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0022130', 'cui_str': 'Islands'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.0476426,The differences between the groups were not statistically significant but suggest that the audio summary might improve knowledge transfer compared to written summaries.,"[{'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Maguire', 'Affiliation': ""All-Ireland Hub for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Institute of Clinical Science, Belfast, BT12 6BJ, UK lisa.maguire@qub.ac.uk.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""All-Ireland Hub for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Institute of Clinical Science, Belfast, BT12 6BJ, UK.""}]",Journal of the Royal Society of Medicine,['10.1177/0141076814546710'] 1534,25393934,Effects of overnight fasting on working memory-related brain network: an fMRI study.,"Glucose metabolism serves as the central source of energy for the human brain. Little is known about the effects of blood glucose level (BGL) on higher-order cognitive functions within a physiological range (e.g., after overnight fasting). In this randomized, placebo-controlled, double blind study, we assessed the impact of overnight fasting (14 h) on brain activation during a working memory task. We sought to mimic BGLs that occur naturally in healthy humans after overnight fasting. After standardized periods of food restriction, 40 (20 male) healthy participants were randomly assigned to receive either glucagon to balance the BGL or placebo (NaCl). A parametric fMRI paradigm, including 2-back and 0-back tasks, was used. Subclinically low BGL following overnight fasting was found to be linked to reduced involvement of the bilateral dorsal midline thalamus and the bilateral basal ganglia, suggesting high sensitivity of those regions to minimal changes in BGLs. Our results indicate that overnight fasting leads to physiologically low levels of glucose, impacting brain activation during working memory tasks even when there are no differences in cognitive performance.",2015,"Subclinically low BGL following overnight fasting was found to be linked to reduced involvement of the bilateral dorsal midline thalamus and the bilateral basal ganglia, suggesting high sensitivity of those regions to minimal changes in BGLs.","['healthy humans after overnight fasting', '40 (20 male) healthy participants']","['overnight fasting', 'glucagon to balance the BGL or placebo (NaCl', 'placebo']","['working memory-related brain network', 'brain activation', 'cognitive performance']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",,0.118813,"Subclinically low BGL following overnight fasting was found to be linked to reduced involvement of the bilateral dorsal midline thalamus and the bilateral basal ganglia, suggesting high sensitivity of those regions to minimal changes in BGLs.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Chechko', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, RWTH Aachen University, Aachen, Germany; JARA Brain - Translational Brain Medicine, Jülich - Aachen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Vocke', 'Affiliation': ''}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': ''}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Toygar', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuckartz', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Berthold-Losleben', 'Affiliation': ''}, {'ForeName': 'Zacharias G', 'Initials': 'ZG', 'LastName': 'Laoutidis', 'Affiliation': ''}, {'ForeName': 'Stelios', 'Initials': 'S', 'LastName': 'Orfanos', 'Affiliation': ''}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wassenberg', 'Affiliation': ''}, {'ForeName': 'Wölfram', 'Initials': 'W', 'LastName': 'Karges', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kohn', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22668'] 1535,24126622,Presenting quantitative information about placebo rates to patients.,,2013,,[],[],[],[],[],[],,0.146664,,"[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': ''}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2013.10399'] 1536,31865288,Effectiveness of training program combining chakrayoga and meditation.,"Background This study was designed to examine the effectiveness of program combining chakrayoga and meditation on the physical health and disease-related factors and psychological factors of people. Methods Ninety-seven subjects (32-83 years old) who had free from prior experiences in meditation programs or Chakrayoga training courses were assigned to either the experimental group (EXP) (45 subjects; 13 male subjects and 32 female subjects; average age of 60.67 years, SD=11.09 years) or the control group (CONT) of remaining subjects (52 subjects; 14 male subjects and 38 female subjects; average age of 61.58 years, SD=9.70 years). Subjects in the EXP participated in the Chakrayoga Meditation Program for twice a week for 2 h during 6 weeks in each session consisted of 1 h of Chakrayoga and 1 h of meditation. The measurements in this study included the mindfulness, stress response, subjective quality of life, medical symptom checklist, difficulty in emotional regulation and objective of life and sense of control. Results Results revealed that participants in the EXP reported significantly more relief of mindfulness, stress response, subjective quality of life and medical symptom checklist than those in the CONT. Conclusions These findings provide evidence that the Chakrayoga Meditation Program can help relieve the physical health and disease-related factors and psychological factors.",2019,"Results Results revealed that participants in the EXP reported significantly more relief of mindfulness, stress response, subjective quality of life and medical symptom checklist than those in the CONT.","['Methods Ninety-seven subjects (32-83 years old) who had free from prior experiences in meditation programs or Chakrayoga training courses were assigned to either the experimental group (EXP) (45 subjects; 13 male subjects and 32 female subjects; average age of 60.67\xa0years, SD=11.09\xa0years) or the control group (CONT) of remaining subjects (52 subjects; 14 male subjects and 38 female subjects; average age of 61.58\xa0years, SD=9.70\xa0years', 'people']","['program combining chakrayoga and meditation', 'Chakrayoga Meditation Program', 'training program combining chakrayoga and meditation']","['relief of mindfulness, stress response, subjective quality of life and medical symptom checklist', 'mindfulness, stress response, subjective quality of life, medical symptom checklist, difficulty in emotional regulation and objective of life and sense of control']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150277'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0034380'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0021783', 'cui_str': 'Sense of Control'}]",97.0,0.0119034,"Results Results revealed that participants in the EXP reported significantly more relief of mindfulness, stress response, subjective quality of life and medical symptom checklist than those in the CONT.","[{'ForeName': 'Yoon-Ju', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Physiology, College of Medicine, 26 KyungHee-daero, Kyung Hee University, Seoul, 130-701, Korea.'}, {'ForeName': 'Kyo-Lin', 'Initials': 'KL', 'LastName': 'Sim', 'Affiliation': 'Department of Psychology, Ajou University, Suwon, Korea.'}, {'ForeName': 'Sung-Ja', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': 'School of Law, Kangwon National University, Kangwon-do, Korea.'}, {'ForeName': 'Gyeongran', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, College of Medicine, 26 KyungHee-daero, Kyung Hee University, Seoul, 130-701, Korea.'}, {'ForeName': 'Il Kyung', 'Initials': 'IK', 'LastName': 'Jung', 'Affiliation': 'Acupuncture Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Changshik', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': 'Acupuncture Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Hongman', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Acupuncture Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Jung-Sup', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Nungin University, Gyunggi-do, Korea.'}, {'ForeName': 'Jaehwan', 'Initials': 'J', 'LastName': 'Ryu', 'Affiliation': 'Department of Physiology, College of Medicine, 26 KyungHee-daero, Kyung Hee University, Seoul, 130-701, Korea.'}, {'ForeName': 'Wan-Suk', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, Ajou University, Suwon, Korea.'}, {'ForeName': 'Insop', 'Initials': 'I', 'LastName': 'Shim', 'Affiliation': 'Department of Physiology, College of Medicine, 26 KyungHee-daero, Kyung Hee University, Seoul, 130-701, Korea.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2018-0167'] 1537,24778230,Field experiments of success-breeds-success dynamics.,"Seemingly similar individuals often experience drastically different success trajectories, with some repeatedly failing and others consistently succeeding. One explanation is preexisting variability along unobserved fitness dimensions that is revealed gradually through differential achievement. Alternatively, positive feedback operating on arbitrary initial advantages may increasingly set apart winners from losers, producing runaway inequality. To identify social feedback in human reward systems, we conducted randomized experiments by intervening in live social environments across the domains of funding, status, endorsement, and reputation. In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients. However, success exhibited decreasing marginal returns, with larger initial advantages failing to produce much further differentiation. These findings suggest a lesser degree of vulnerability of reward systems to incidental or fabricated advantages and a more modest role for cumulative advantage in the explanation of social inequality than previously thought.",2014,In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients.,['human reward systems'],[],['subsequent rates of success'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],[],,0.0329269,In each system we consistently found that early success bestowed upon arbitrarily selected recipients produced significant improvements in subsequent rates of success compared with the control group of nonrecipients.,"[{'ForeName': 'Arnout', 'Initials': 'A', 'LastName': 'van de Rijt', 'Affiliation': 'Departments of Sociology andInstitute for Advanced Computational Science, Stony Brook, NY 11794; arnout.vanderijt@stonybrook.edu.'}, {'ForeName': 'Soong Moon', 'Initials': 'SM', 'LastName': 'Kang', 'Affiliation': 'Department of Management Science and Innovation, University College London, London WC1E 6BT, United Kingdom; and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Restivo', 'Affiliation': 'Department of Sociology, State University of New York, Geneseo, NY 14454.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Computer Science, State University of New York, Stony Brook, NY 11794;'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1316836111'] 1538,24142460,Antihistamine induced blood oxygenation level dependent response changes related to visual processes during sensori-motor performance.,"The histaminergic involvement in selective processes underlying its role in human sensori-motor performance is largely unknown. Recently, selective effects of central H₁-inverse agonism on sensory visual processes were observed in electrophysiological--but not behavioral data; a discrepancy suggested to result from speeded response-choice related processes. This study attempts to establish the effects on visual processes and identify putative compensatory mechanisms related to increased visual and response-choice task demands by assessing H₁-inverse agonism induced changes in blood oxygenation level dependent (BOLD) response. Twelve participants received oral doses of dexchlorpheniramine 4 mg, lorazepam 1 mg, and placebo in a three-way crossover designed study. Brain activity was assessed for choice reaction time task performance in a 3 T magnetic resonance scanner 2 h after drug administration. Participants responded with their left or right hand and index or middle finger as indicated by the laterality of stimulus presentation and identity of the stimulus, respectively. Stimuli were intact or visually degraded and responses were compatible or incompatible with the laterality of stimulus presentation. Both dexchlorpheniramine and lorazepam affected the BOLD response in the occipital cortex indicating affected visual information processing. Dexchlorpheniramine decreased BOLD response in the dorsal precuneus and left precentral gyrus as part of a motor network, which however might not be interpreted as a compensatory mechanism, but may be the upstream consequence of impaired visual processing.",2014,"Dexchlorpheniramine decreased BOLD response in the dorsal precuneus and left precentral gyrus as part of a motor network, which however might not be interpreted as a compensatory mechanism, but may be the upstream consequence of impaired visual processing.",[],"['dexchlorpheniramine and lorazepam', 'Dexchlorpheniramine', 'Antihistamine', 'dexchlorpheniramine 4 mg, lorazepam 1 mg, and placebo']","['blood oxygenation level', 'sensory visual processes', 'Brain activity', 'blood oxygenation level dependent (BOLD) response', 'BOLD response']",[],"[{'cui': 'C0057606', 'cui_str': 'dexchlorpheniramine'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C1596161', 'cui_str': 'Lorazepam 1 MG [Ativan]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",12.0,0.0857301,"Dexchlorpheniramine decreased BOLD response in the dorsal precuneus and left precentral gyrus as part of a motor network, which however might not be interpreted as a compensatory mechanism, but may be the upstream consequence of impaired visual processing.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Ruitenbeek', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': ''}, {'ForeName': 'Mitul Ashok', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Eva Isabell', 'Initials': 'EI', 'LastName': 'Drexler', 'Affiliation': ''}, {'ForeName': 'Willem Jan', 'Initials': 'WJ', 'LastName': 'Riedel', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22387'] 1539,24659430,Oxytocin facilitates the sensation of social stress.,"Essentially all social species experience social stress which can be a catalyst for detriments in mental and physical health. The neuropeptide oxytocin (OXT) has been shown to produce anxiolytic and antistress effects, thereby qualifying the OXT system as a promising drug target in the treatment of stress-related disorders. However, recently it has been shown that OXT can have anxiogenic effects as well. In the present study, we used functional magnetic resonance imaging to scan the brains of 60 healthy men while they were exposed to social stress after they received either intranasal OXT (24 IU) or placebo treatment. Although OXT administration did not alter salivary cortisol levels as a surrogate marker of stress axis activity, our participants initially reported an increment in perceived social stress. This behavioral effect was paralleled on the neural level by increased activity in the precuneus and cingulate cortex. Taken together, our results support the hypothesis that OXT can induce a self-referential processing bias which facilitates the sensation of social stress in the absence of altered endocrine responses.",2014,This behavioral effect was paralleled on the neural level by increased activity in the precuneus and cingulate cortex.,['60 healthy men'],"['neuropeptide oxytocin (OXT', 'placebo treatment', 'functional magnetic resonance imaging', 'Oxytocin', 'intranasal OXT', 'OXT']","['salivary cortisol levels', 'sensation of social stress']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",60.0,0.0164868,This behavioral effect was paralleled on the neural level by increased activity in the precuneus and cingulate cortex.,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, Germany; Department of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': ''}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': ''}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22508'] 1540,24862297,Early life stress modulates amygdala-prefrontal functional connectivity: implications for oxytocin effects.,"Recent evidence suggests that early life stress (ELS) changes stress reactivity via reduced resting state functional connectivity (rs-FC) between amygdala and the prefrontal cortex. Oxytocin (OXT) modulates amygdala connectivity and attenuates responses to psychosocial stress, but its effect appears to be moderated by ELS. Here we first investigate the effect of ELS on amygdala-prefrontal rs-FC, and examine whether ELS-associated changes of rs-FC in this neural circuit predict its response to psychosocial stress. Secondly, we explore the joint effect of OXT and ELS on the amygdala-prefrontal circuit. Eighteen healthy young males participated in a resting-state fMRI study of OXT effects using a double-blind, randomized, placebo-controlled, within-subject crossover design. We measured the rs-FC to bilateral amygdalae and subsequently assessed changes of state anxiety and prefrontal responses to psychosocial stress. Multiple linear regressions showed that ELS, specifically emotional abuse, predicted reduced rs-FC between the right amygdala and pregenual anterior cingulate cortex (pgACC), which in turn predicted elevated state anxiety after psychosocial stress. In subjects with lower ELS scores, stronger pgACC-amygdala rs-FC predicted stronger pgACC deactivation during the psychosocial stress task, and this rest-task interaction was attenuated by OXT. In subjects with higher ELS scores however, the rest-task interaction was altered and OXT showed no significant effect. These findings highlight that ELS reduces pgACC-amygdala rs-FC and alters how rs-FC of this circuit predicts its stress responsiveness. Such changes in pgACC-amygdala functional dynamics may underlie the altered sensitivity to the effects of OXT after ELS.",2014,"In subjects with higher ELS scores however, the rest-task interaction was altered and OXT showed no significant effect.",['Eighteen healthy young males'],"['ELS', 'OXT and ELS', 'placebo', 'Oxytocin (OXT']",[],"[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],18.0,0.0333958,"In subjects with higher ELS scores however, the rest-task interaction was altered and OXT showed no significant effect.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Cluster of Excellence ""Languages of Emotion"",, Freie Universität Berlin, Berlin, Germany; Department of Psychiatry, Campus Benjamin Franklin, Charité Berlin, Berlin, Germany; Dahlem Institute for Neuroimaging of Emotion, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'Herrera-Melendez', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Pestke', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Feeser', 'Affiliation': ''}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Aust', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': ''}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': ''}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Böker', 'Affiliation': ''}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Bajbouj', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Grimm', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22553'] 1541,30802897,Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial.,"Background Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343). Setting 41 dialysis facilities in 3 U.S. metropolitan areas. Participants Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C) at 12 weeks. Results The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, -12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.",2019,"Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035).","['Setting\n\n\n41 dialysis facilities in 3 U.S. metropolitan areas', 'Patients Undergoing Maintenance Hemodialysis', 'patients receiving maintenance hemodialysis', 'Participants\n\n\nPatients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2', 'patients receiving hemodialysis']","['CBT', 'sertraline', 'cognitive behavioral therapy (CBT) versus sertraline', 'CBT, sertraline']","['Adverse events', 'depressive symptoms', 'lower QIDS-C depression scores', 'depression scores', 'Quick Inventory of Depressive Symptoms-Clinician-Rated (QIDS-C']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",184.0,0.122357,"Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, -1.84 [CI, -3.54 to -0.13]; P = 0.035).","[{'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cukor', 'Affiliation': 'State University of New York Downstate Medical Center, Brooklyn, New York (D.C., N.V.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Unruh', 'Affiliation': 'University of New Mexico, Albuquerque, New Mexico (M.U., D.K.Q.).'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Cohen', 'Affiliation': 'George Washington University, Washington, DC (S.D.C.).'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Dember', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania (L.M.D.).'}, {'ForeName': 'Yaminette', 'Initials': 'Y', 'LastName': 'Diaz-Linhart', 'Affiliation': 'Boston University, Boston, Massachusetts (Y.D.).'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Dubovsky', 'Affiliation': 'University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'University of Utah, Salt Lake City, Utah (T.G.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Grote', 'Affiliation': 'University of Washington, Seattle, Washington (R.M., T.R., P.H., A.D., N.G.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kutner', 'Affiliation': 'Emory University, Atlanta, Georgia (N.K.).'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, Texas (M.H.T., S.S.H.).'}, {'ForeName': 'Davin K', 'Initials': 'DK', 'LastName': 'Quinn', 'Affiliation': 'University of New Mexico, Albuquerque, New Mexico (M.U., D.K.Q.).'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Ver Halen', 'Affiliation': 'State University of New York Downstate Medical Center, Brooklyn, New York (D.C., N.V.).'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Weisbord', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System and University of Pittsburgh, Pittsburgh, Pennsylvania (S.D.W.).'}, {'ForeName': 'Bessie A', 'Initials': 'BA', 'LastName': 'Young', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington (B.A.Y.).'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Kimmel', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland (P.L.K.).'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'University of Texas Southwestern, Dallas, Texas (M.H.T., S.S.H.).'}]",Annals of internal medicine,['10.7326/M18-2229'] 1542,25094043,Opposing effects of oxytocin on moral judgment in males and females.,"Current perspectives on the evolutionary roots of human morality suggest it arose to incentivize social cooperation by promoting feelings of disgust toward selfish behavior, although the underlying neural mechanisms remain unclear. To investigate whether the ancient mammalian neuropeptide oxytocin (OXT) influences self-referential processing in the domains of emotion evaluation and moral decision making, we conducted a pharmaco-functional magnetic resonance imaging (fMRI) and a behavioral experiment involving 157 healthy women and men who were treated with either OXT (24 IU) or placebo (PLC) intranasally. Our results show that OXT facilitated cortical midline responses during self-processing of disgust and selectively promoted self-interest moral judgments in men. In contrast, in women OXT increased the reaction time difference between accepted and rejected moral dilemmas and led them to suppress their self-interest and respond more altruistically for the benefit of others. Taken together, these findings suggest an OXT-related sexual dimorphism in human moral behavior which evolved adaptively to optimize both protection and nurturing of offspring by promoting selfish behavior in men and altruistic behavior in women.",2014,"In contrast, in women OXT increased the reaction time difference between accepted and rejected moral dilemmas and led them to suppress their self-interest and respond more altruistically for the benefit of others.","['157 healthy women and men who were treated with either', 'males and females']","['oxytocin', 'ancient mammalian neuropeptide oxytocin (OXT', 'placebo (PLC) intranasally', 'pharmaco-functional magnetic resonance imaging (fMRI', 'OXT']",['reaction time difference'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}]",157.0,0.0613084,"In contrast, in women OXT increased the reaction time difference between accepted and rejected moral dilemmas and led them to suppress their self-interest and respond more altruistically for the benefit of others.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Department of Psychiatry, University of Bonn, Bonn, Germany; Department of Medical Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Striepens', 'Affiliation': ''}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schwering', 'Affiliation': ''}, {'ForeName': 'Janka', 'Initials': 'J', 'LastName': 'Noelle', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wille', 'Affiliation': ''}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Schläpfer', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22605'] 1543,24862742,The effects of methylphenidate on whole brain intrinsic functional connectivity.,"Methylphenidate (MPH) is an indirect dopaminergic and noradrenergic agonist that is used to treat attention deficit hyperactivity disorder and that has shown therapeutic potential in neuropsychiatric diseases such as depression, dementia, and Parkinson's disease. While effects of MPH on task-induced brain activation have been investigated, little is known about how MPH influences the resting brain. To investigate the effects of 40 mg of oral MPH on intrinsic functional connectivity, we used resting state fMRI in 54 healthy male subjects in a double-blind, randomized, placebo-controlled study. Functional connectivity analysis employing ICA revealed seven resting state networks (RSN) of interest. Connectivity strength between the dorsal attention network and the thalamus was increased after MPH intake. Other RSN located in association cortex areas, such as the left and right frontoparietal networks and the executive control network, showed MPH-induced connectivity increase to sensory-motor and visual cortex regions and connectivity decrease to cortical and subcortical components of cortico-striato-thalamo-cortical circuits (CST). RSN located in sensory-motor cortex areas showed the opposite pattern with MPH-induced connectivity increase to CST components and connectivity decrease to sensory-motor and visual cortex regions. Our results provide evidence that MPH does not only alter intrinsic connectivity between brain areas involved in sustained attention, but that it also induces significant changes in the cortico-cortical and cortico-subcortical connectivity of many other cognitive and sensory-motor RSN.",2014,"Other RSN located in association cortex areas, such as the left and right frontoparietal networks and the executive control network, showed MPH-induced connectivity increase to sensory-motor and visual cortex regions and connectivity decrease to cortical and subcortical components of cortico-striato-thalamo-cortical circuits (CST).",['54 healthy male subjects'],"['methylphenidate', 'placebo', 'MPH', 'oral MPH', 'Methylphenidate (MPH']","['whole brain intrinsic functional connectivity', 'Connectivity strength', 'intrinsic functional connectivity']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",54.0,0.069924,"Other RSN located in association cortex areas, such as the left and right frontoparietal networks and the executive control network, showed MPH-induced connectivity increase to sensory-motor and visual cortex regions and connectivity decrease to cortical and subcortical components of cortico-striato-thalamo-cortical circuits (CST).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Mueller', 'Affiliation': 'Institute of Clinical Radiology, Ludwig-Maximilians University Munich, 81377, Munich, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keeser', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pogarell', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Berman', 'Affiliation': ''}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'Maximilian F', 'Initials': 'MF', 'LastName': 'Reiser', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Riedel', 'Affiliation': ''}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Möller', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meindl', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22557'] 1544,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear. METHOD In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs). RESULTS Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months. LIMITATIONS Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs. CONCLUSIONS ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035'] 1545,32059954,All-Inside Quadrupled Semitendinosus Autograft Shows Stability Equivalent to Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial in Athletes 24 Years or Younger.,"PURPOSE To compare clinical outcomes of knee anterior cruciate ligament (ACL) autograft reconstruction using all-inside quadrupled semitendinosus (AIST) versus bone-patellar tendon-bone (BPTB) in a high-risk athletic population 24 years or younger. METHODS Skeletally mature candidates younger than 24 years old with an ACL tear were randomized into either the AIST (n = 32) or BPTB (n = 32) group and were followed for 2 years. Magnetic resonance imaging scans were obtained at 1-year follow-up, and radiographs were obtained at 2-year follow-up. All surgeries were performed by a single surgeon using an anteromedial portal to establish the femoral tunnel. The primary outcome measure was KT-1000 stability testing. Secondary outcome measures included International Knee Documentation Committee (IKDC) Knee Evaluation Form, IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score, Marx Activity Scale, visual analog pain scale, and SF-12 (Mental and Physical). RESULTS At 2-year follow-up, no statistical difference existed with KT-1000-measured side-to-side laxity between AIST (0.3 ± 0.7 mm, 95% confidence interval 0.0-1.0 mm) and BPTB (0.0 ± 0.8 mm, confidence interval CI -0.3 to 1.1 mm) (P = .197). In addition, no statistical differences between the groups were found for IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score, Marx, SF-12 Mental, SF-12 Physical, or with regards to imaging findings. Patients with BPTB reported significantly greater postoperative pain scores at days 2 (P = .049), 3 (P = .004), and 7 (P = .015) and had significantly greater kneeling pain at 2 years (P < .019). A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; P = .415). Two graft retears (7%; P = .222) occurred in the AIST group. Three patients in the BPTB group experienced ACL tears in the contralateral knee (9%; P = .239). CONCLUSIONS ACL reconstruction with an all-inside quadrupled semitendinosus autograft construct is equivalent to patellar BPTB autograft based on KT-1000 stability testing in athletes 24 years or younger. LEVEL OF EVIDENCE randomized controlled trial with 92% 2-year follow-up, Level I.",2020,"A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; p=0.415).","['Skeletally mature candidates younger than 24 years old with an ACL tear', 'Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction', 'high-risk athletic population 24 years or younger', 'Athletes 24 Years or Younger', 'athletes 24 years or younger']","['AIST', 'BPTB', 'patellar BPTB autograft based on KT-1000 stability testing', 'knee anterior cruciate ligament (ACL) autograft reconstruction using all-inside quadrupled semitendinosus (AIST) versus bone-patellar tendon-bone (BPTB']","['KT- 1000 stability testing', 'KT-1000 measured side to side laxity', 'ACL tears', 'IKDC Knee Evaluation Form, IKDC Subjective Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Marx Activity Scale, VAS Pain Scale and SF-12 (Mental and Physical', 'kneeling pain', 'MRIs', 'preoperative level of sport activity', 'postoperative pain scores', 'IKDC Subjective Form, KOOS, Marx, SF-12 Mental, SF-12 Physical or with regards to imaging findings']","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0078960', 'cui_str': 'Anterior Cranial Cruciate Ligament'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1260920', 'cui_str': 'Kneeling (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1287399', 'cui_str': 'Imaging finding'}]",,0.0468013,"A return to sport questionnaire at 2 years revealed no significant difference between the groups for returning to preoperative level of sport activity (83% AIST, 74% BPTB; p=0.415).","[{'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia, Missouri, U.S.A.; Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.. Electronic address: psmithmudoc@aol.com.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cook', 'Affiliation': 'Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Bley', 'Affiliation': 'Columbia Orthopaedic Group, Columbia, Missouri, U.S.A.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.01.048'] 1546,23907764,Intranasal insulin increases regional cerebral blood flow in the insular cortex in men independently of cortisol manipulation.,"Insulin and cortisol play a key role in the regulation of energy homeostasis, appetite, and satiety. Little is known about the action and interaction of both hormones in brain structures controlling food intake and the processing of neurovisceral signals from the gastrointestinal tract. In this study, we assessed the impact of single and combined application of insulin and cortisol on resting regional cerebral blood flow (rCBF) in the insular cortex. After standardized periods of food restriction, 48 male volunteers were randomly assigned to receive either 40 IU intranasal insulin, 30 mg oral cortisol, both, or neither (placebo). Continuous arterial spin labeling (CASL) sequences were acquired before and after pharmacological treatment. We observed a bilateral, locally distinct rCBF increase after insulin administration in the insular cortex and the putamen. Insulin effects on rCBF were present regardless of whether participants had received cortisol or not. Our results indicate that insulin, but not cortisol, affects blood flow in human brain structures involved in the regulation of eating behavior.",2014,"We observed a bilateral, locally distinct rCBF increase after insulin administration in the insular cortex and the putamen.",['48 male volunteers'],"['40 IU intranasal insulin, 30 mg oral cortisol, both, or neither (placebo', 'Intranasal insulin', 'insulin and cortisol']","['resting regional cerebral blood flow (rCBF', 'Continuous arterial spin labeling (CASL) sequences', 'regional cerebral blood flow']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",48.0,0.033748,"We observed a bilateral, locally distinct rCBF increase after insulin administration in the insular cortex and the putamen.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Schilling', 'Affiliation': 'Institute of Psychobiology, Division of Clinical Psychophysiology, University of Trier, Trier, Germany.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Ferreira de Sá', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Westerhausen', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Strelzyk', 'Affiliation': ''}, {'ForeName': 'Mauro F', 'Initials': 'MF', 'LastName': 'Larra', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': ''}, {'ForeName': 'Egemen', 'Initials': 'E', 'LastName': 'Savaskan', 'Affiliation': ''}, {'ForeName': 'Melly S', 'Initials': 'MS', 'LastName': 'Oitzl', 'Affiliation': ''}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Busch', 'Affiliation': ''}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Naumann', 'Affiliation': ''}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22304'] 1547,32426882,A randomized controlled trial of different young child formulas on upper respiratory and gastrointestinal tract infections in Chinese toddlers.,"BACKGROUND Bioactive proteins and human milk oligosaccharides (HMOs), important ingredients in breast milk, that protect against infections are lacking in young child formula (YCF). This study investigated the effects of new YCFs on respiratory and gastrointestinal infections in toddlers. METHODS Four hundred and sixty one healthy Chinese children aged 1-2.5 years were recruited in this randomized, controlled, double-blind, parallel-group clinical trial of different YCFs. They were randomly assigned to either standard milk formula (YCF-Ref) or one of three new YCFs containing bioactive proteins and/or the HMO 2'-fucosyllactose (2'-FL) and/or milk fat for six months. Primary outcomes were incidence of upper respiratory tract infection (URTI) and duration of gastrointestinal tract infections (GITI). RESULTS There were no significant between-group differences in primary outcomes. For secondary outcomes, subjects receiving 2'-FL-supplemented YCF had longer URTI. Subjects receiving YCF supplemented with milk fat and intact bioactive proteins, and 2'-FL at levels found in breast milk, had more GITI episodes and shorter time to first GITI but similar effects on URTI duration than YCF-Ref recipients. No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breast milk. Occurrence of adverse events and anthropometry were similar in all groups. CONCLUSIONS All three YCFs supplemented with different combinations of intact bioactive proteins, 2'-FL, and milk fat are safe in toddlers. No difference is detected among YCFs on URTI incidence and GITI duration. Further studies are needed to verify these findings especially in infants who may benefit most from the immune-boosting effects of bioactive proteins and HMOs.",2020,No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breastmilk.,"['461 healthy Chinese children aged 1-2.5 years', 'Chinese Toddlers', 'toddlers']","['new YCFs', 'YCF', ""2'-FL-supplemented YCF"", ""standard milk formula (YCF-Ref) or one of three new YCFs containing bioactive proteins and/or the HMO 2'-fucosyllactose (2'-FL) and/or milk fat for six months""]","['URTI and GITI', 'Upper Respiratory and Gastrointestinal Tract Infections', 'longer URTI', 'URTI incidence and GITI duration', 'incidence of upper respiratory tract infection (URTI) and duration of gastrointestinal tract infections (GITI', 'URTI duration']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0045214', 'cui_str': ""2'-fucosyllactose""}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018720', 'cui_str': 'Health maintenance organization'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",461.0,0.0815698,No effects on URTI and GITI were observed in toddlers receiving YCF with bioactive proteins at lower levels than breastmilk.,"[{'ForeName': 'Ting F', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Laurien H', 'Initials': 'LH', 'LastName': 'Ulfman', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'Marc K C', 'Initials': 'MKC', 'LastName': 'Chong', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kam L', 'Initials': 'KL', 'LastName': 'Hon', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ilse M S L', 'Initials': 'IMSL', 'LastName': 'Khouw', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'Paul K S', 'Initials': 'PKS', 'LastName': 'Chan', 'Affiliation': 'Department of Microbiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Dianne J', 'Initials': 'DJ', 'LastName': 'Delsing', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}, {'ForeName': 'Guus A M', 'Initials': 'GAM', 'LastName': 'Kortman', 'Affiliation': 'NIZO, Ede, The Netherlands.'}, {'ForeName': 'Ingeborg M J', 'Initials': 'IMJ', 'LastName': 'Bovee-Oudenhoven', 'Affiliation': 'FrieslandCampina, Amersfoort, The Netherlands.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13276'] 1548,17946174,VALUE: Virtual Assisted Living Umbrella for the Elderly -- user patterns.,"VALUE is a randomized controlled trial to evaluate the impact of a home telehealth program on the ability of frail elderly individuals to remain living independently in their own home as their self-care abilities decline. VALUE uses broadband access to provide virtual visits with a home care nurse, a Web portal for ordering assisted living services, physiological monitoring, and access to the Internet. Subjects were able to use the VALUE program technology without difficulty after a brief instruction session with the nurse.",2006,VALUE is a randomized controlled trial to evaluate the impact of a home telehealth program on the ability of frail elderly individuals to remain living independently in their own home as their self-care abilities decline.,['frail elderly individuals'],['home telehealth program'],[],"[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.020871,VALUE is a randomized controlled trial to evaluate the impact of a home telehealth program on the ability of frail elderly individuals to remain living independently in their own home as their self-care abilities decline.,"[{'ForeName': 'Stanley M', 'Initials': 'SM', 'LastName': 'Finkelstein', 'Affiliation': 'Dept. of Lab. Medicine & Pathology, Minnesota Univ., Minneapolis, MN 55455, USA. stan@umn.edu'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Speedie', 'Affiliation': ''}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ratner', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Potthoff', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,[] 1549,32002556,Final report from Intergroup NCCTG 86-72-51 (Alliance): a phase III randomized clinical trial of high-dose versus low-dose radiation for adult low-grade glioma.,"BACKGROUND The optimal radiation dose for adult supratentorial low-grade glioma is unknown. The aim of this study was to provide a final update on oncologic and cognitive outcomes of high-dose versus low-dose radiation for low-grade glioma. METHODS Between 1986 and 1994, 203 patients with supratentorial low-grade glioma were randomized (1:1) to 50.4 Gy in 28 fractions versus 64.8 Gy in 36 fractions after any degree of resection. RESULTS For all patients, median overall survival (OS) was 8.4 years (95% CI: 7.2-10.8). Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3-6.6). Median follow-up is 17.2 years for the 33 patients still alive. High-dose radiation did not improve 15-year OS (22.4%) versus low-dose radiation (24.9%, log-rank P = 0.978) or 15-year PFS (high dose, 15.2% vs low dose, 9.5%; P = 0.7142). OS was significantly better for patients with preoperative tumor diameter <5 cm and baseline Mini-Mental State Examination (MMSE) >27 and who underwent gross total resection. PFS was improved for patients with oligodendroglioma versus astrocytoma, preoperative tumor diameter <5 cm, patients who had gross total resection, and patients with baseline MMSE >27. For patients who had normal MMSE at baseline, at 7 years only 1 patient (5%) had a clinically significant decrease in MMSE from the previous time point, with the remainder (95%) stable. None had decrease in MMSE at 10, 12, or 15 years. CONCLUSIONS Long-term follow-up indicates no benefit to high-dose over low-dose radiation for low-grade gliomas. Cognitive function appeared to be stable after radiation as measured by MMSE.",2020,Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3 - 6.6).,"['adult low-grade glioma', 'Between 1986 and 1994', '203 patients with supratentorial low grade glioma', 'adult supratentorial low grade glioma']",[],"['Median progression-free survival (PFS', 'median OS', 'Cognitive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1997217', 'cui_str': 'Low grade glioma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",203.0,0.086495,Median progression-free survival (PFS) was 5.2 years (95% CI: 4.3 - 6.6).,"[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Breen', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': ""O'Neill"", 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Curran', 'Affiliation': 'Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Levitt', 'Affiliation': 'Fargo Clinic, North Fargo, North Dakota.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Shaw', 'Affiliation': 'Wake Forest Baptist Health, Winston-Salem, North Carolina.'}]",Neuro-oncology,['10.1093/neuonc/noaa021'] 1550,17945759,Alterations in human EEG activity caused by extremely low frequency electromagnetic fields.,"This study has investigated whether extremely low frequency (ELF) electromagnetic fields (EMFs) can alter human brain activity. Linearly polarised magnetic flux density of 20 muT (rms) was generated using a standard double Helmholtz coils and applied to the human head over a sequence of 1 minute stimulations followed by one minute without stimulation in the following order of frequencies 50, 16.66, 13, 10, 8.33 and 4 Hz. We collected recordings on 33 human volunteers under double-blind counter-balanced conditions. Each stimulation lasted for two minutes followed by one minute post-stimulation EEG recording. The same procedure was repeated for the EMF control sessions, where the order of control and exposure sessions was determined randomly according to the subject's ID number. The rest period between two conditions (exposure and control) was 30 minutes. The results indicate that there was a significant increase in Alpha1, Alpha2, and Beta1 at the frontal brain region, and a significant decrease in Alpha2 band in parietal and occipital region due to EMF exposure.",2006,"The results indicate that there was a significant increase in Alpha1, Alpha2, and Beta1 at the frontal brain region, and a significant decrease in Alpha2 band in parietal and occipital region due to EMF exposure.",['33 human volunteers under double-blind counter-balanced conditions'],['extremely low frequency (ELF) electromagnetic fields (EMFs'],"['Alpha1, Alpha2, and Beta1 at the frontal brain region']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}]",33.0,0.0270319,"The results indicate that there was a significant increase in Alpha1, Alpha2, and Beta1 at the frontal brain region, and a significant decrease in Alpha2 band in parietal and occipital region due to EMF exposure.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cvetkovic', 'Affiliation': 'Sch. of Electr. & Comput. Eng., RMIT Univ., Melbourne, VIC, Australia. dean.cvetkovic@rmit.edu.au'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jovanov', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cosic', 'Affiliation': ''}]",Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference,[] 1551,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up. METHODS Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period. RESULTS Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms. LIMITATIONS As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors. CONCLUSION MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182'] 1552,31365113,Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial.,"Importance Enhanced medical rehabilitation (EMR) is a systematic and standardized approach for physical and occupational therapists to engage patients. Higher patient engagement in therapy might lead to improved functional recovery in rehabilitation settings, such as skilled nursing facilities (SNFs). Objective To determine whether EMR improves older adults' functional recovery. Design, Setting, and Participants A double-blind, parallel-group, randomized clinical trial was conducted from July 29, 2014, to July 13, 2018, in 229 adults aged 65 years or older admitted to 2 US SNFs. Participants were randomized to receive EMR (n = 114) vs standard-of-care rehabilitation (n = 115). Intention-to-treat analysis was used. Interventions The intervention group received their physical and occupational therapy from therapists trained in EMR. Based on models of motivation and behavior change, EMR is a toolkit of techniques to increase patient engagement and therapy intensity. The control group received standard-of-care rehabilitation from physical and occupational therapists not trained in EMR. Main Outcomes and Measures The primary outcome was change in function in activities of daily living and mobility, as assessed with the Barthel Index, which measures 10 basic activities of daily living or mobility items (scale range, 0-100), from SNF admission to discharge; secondary outcomes were gait speed for 10 m, 6-minute walk test, discharge disposition, rehospitalizations, and self-reported functional status at days 30, 60, and 90. To examine the rehabilitation process, therapists' engagement with patients and patient active time during therapy were measured for a sample of the sessions. Results Of the 229 participants, 149 (65.1%) were women; 177 (77.3%) were white, and 51 (22.3%) were black; mean (SD) age was 79.3 (8.0) years. Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007). There was no evidence of a difference in the length of stay (mean [SD], 23.5 [13.1] days). However, there were no group by time differences in secondary outcome measures, including self-reported function after SNF discharge out to 90 days as measured on the Barthel Index (mean [SE] score: EMR, 83.65 [2.20]; standard of care, 84.67 [2.16]; P = .96). The EMR therapists used a median (interquartile range) of 24.4 (21.0-37.3) motivational messages per therapy session vs 2.3 (1.1-2.9) for nontrained therapists (P < .001), and EMR patients were active during a mean (SD) of 52.5 (6.6%) of the therapy session time vs 41.2 (6.8%) for nontrained therapists (P = .001). Conclusions and Relevance Enhanced medical rehabilitation modestly improved short-term functional recovery for selected older adults rehabilitating in SNFs. However, there was no evidence that the benefits persisted over the longer term. This study demonstrates the value of engaging and motivating older adults in rehabilitation therapy, but more work is needed to extend these benefits to longer-term outcomes after discharge home. Trial Registration ClinicalTrials.gov identifier: NCT02114879.",2019,"Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007).","['229 participants, 149 (65.1%) were women; 177 (77.3%) were white, and 51 (22.3%) were black', 'n\u2009=\u2009114', 'selected older adults rehabilitating in SNFs', '229 adults aged 65 years or older admitted to 2 US SNFs', 'Older Adults Receiving Skilled Nursing Care']","['Importance\n\n\nEnhanced medical rehabilitation (EMR', 'physical and occupational therapy from therapists trained in EMR', 'EMR', 'standard-of-care rehabilitation from physical and occupational therapists not trained in EMR', 'EMR ', 'Enhanced Medical Rehabilitation']","['self-reported function after SNF discharge out to 90 days as measured on the Barthel Index', 'length of stay', 'change in function in activities of daily living and mobility, as assessed with the Barthel Index, which measures 10 basic activities of daily living or mobility items (scale range, 0-100), from SNF admission to discharge; secondary outcomes were gait speed for 10 m, 6-minute walk test, discharge disposition, rehospitalizations, and self-reported functional status', 'recovery of function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",229.0,0.235244,"Participants assigned to EMR showed greater recovery of function than those assigned to standard of care (mean increase in Barthel Index score, 35 points; 95% CI, 31.6-38.3 vs 28 points; 95% CI, 25.2-31.7 points; P = .007).","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lenard', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Marghuretta', 'Initials': 'M', 'LastName': 'Bland', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Barco', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Lang', 'Affiliation': 'Program in Physical Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morrow-Howell', 'Affiliation': 'Brown School of Social Work, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Baum', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Ellen F', 'Initials': 'EF', 'LastName': 'Binder', 'Affiliation': 'Division of Geriatrics and Nutritional Science, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St Louis, St Louis, Missouri.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8199'] 1553,32035998,Do probiotics prevent antibiotic-associated diarrhoea? Results of a multicentre randomized placebo-controlled trial.,"BACKGROUND Antibiotic-associated diarrhoea (AAD) is a side-effect of antibiotic consumption and probiotics have been shown to reduce AAD. METHODS A multicentre, double-blind, placebo-controlled, randomized trial was conducted to evaluate the role of Lactobacillus casei DN114001 (combined as a drink with two regular yoghurt bacterial strains) in reducing AAD and Clostridioides difficile infection in patients aged over 55 years. The primary outcome was the incidence of AAD during 2 weeks of follow-up. RESULTS A total of 1127 patients (mean age ± standard deviation: 73.6 ± 10.5) were randomized to the active group (N = 549) or placebo group (N = 577). Both groups were followed up as per protocol. The proportion of patients experiencing AAD during follow-up was 19.3% (106/549) in the probiotic group vs 17.9% (103/577) in the placebo group (unadjusted odds ratio 1.10, 95% confidence interval 0.82-1.49, P = 0.53). CONCLUSIONS No significant evidence was found of a beneficial effect of the specific probiotic formulation in preventing AAD in this elderly population drawn from a number of different UK hospitals. However, in the UK and in many other healthcare systems there have, in recent years, been many changes in antibiotic stewardship policies, an overall decrease in incidence in C. difficile infection, as well as an increased awareness of infection prevention, and modifications in nursing practice. In light of these factors, it is impossible to conclude definitively from the current trial that the study-specific probiotic formulation has no role in preventing AAD, and it is our view that further trials may be indicated, controlling for these variables.",2020,We did not find any significant evidence of a beneficial effect of the specific probiotic formulation in preventing AAD in this elderly population drawn from a number of different UK hospitals.,"['patients aged over 55 years', '1127 patients, (mean age + SD 73.6 + 10.5']","['placebo', 'L. casei DN114001 (combined as a drink with two regular yoghurt bacterial strains', 'specific probiotic formulation']","['incidence of AAD', 'AAD and C. difficile infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1127.0,0.467638,We did not find any significant evidence of a beneficial effect of the specific probiotic formulation in preventing AAD in this elderly population drawn from a number of different UK hospitals.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rajkumar', 'Affiliation': 'Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK. Electronic address: C.rajkumar@bsms.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilks', 'Affiliation': 'Barts Health NHS Trust and Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary, University of London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Islam', 'Affiliation': 'Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ali', 'Affiliation': 'Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raftery', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Davies', 'Affiliation': 'Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cheek', 'Affiliation': 'University of Brighton, Brighton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Brighton and Sussex Medical School, Universities of Brighton & Sussex, Brighton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of hospital infection,['10.1016/j.jhin.2020.01.018'] 1554,31833590,Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up.,,2020,,"['out-patients with 1-year follow-up', 'high-risk alcohol consumption']","['placebo', 'Titrated baclofen']",[],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}]",[],,0.179507,,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Rigal', 'Affiliation': 'Université Paris-Saclay, UVSQ, Inserm, CESP, Villejuif, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Sidorkiewicz', 'Affiliation': 'Université de Paris, Faculté de Santé, UFR de Médecine, Département de Médecine Générale, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'Unité de recherche clinique, School of Medicine, Paris Descartes University, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Perrodeau', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Le Jeunne', 'Affiliation': 'Service de médecine interne APHP-Hôpital Cochin, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jaury', 'Affiliation': 'Université de Paris, Faculté de Santé, UFR de Médecine, Département de Médecine Générale, Paris, France.'}]","Addiction (Abingdon, England)",['10.1111/add.14927'] 1555,23281064,Acute tryptophan depletion promotes an anterior-to-posterior fMRI activation shift during task switching in older adults.,"Studies have long reported that aging is associated with declines in several functions modulated by the prefrontal cortex, including executive functions like working memory, set shifting, and inhibitory control. The neurochemical basis to this is poorly understood, but may include the serotonergic system. We investigated the modulatory effect of serotonin using acute tryptophan depletion (ATD) during a cognitive switching task involving visual-spatial set shifting modified for a functional MRI environment. Ten healthy women over 55 years were tested on two separate occasions in this within-group double-blind sham-controlled crossover study to compare behavioral and physiological brain functioning following ATD and following a (""placebo"") sham depletion condition. ATD did not significantly affect task performance. It did modulate brain functional recruitment. During sham depletion women significantly activated the expected task-relevant brain regions associated with the Switch task including prefrontal and anterior cingulate cortices. In contrast, following ATD participants activated posterior regions of brain more during switch than repeat trials. In addition to the main effects of depletion condition, a comparison of the ATD relative to the sham condition confirmed this anterior-to-posterior shift in activation. The posterior (increased) activation clusters significantly and negatively correlated with the reduced prefrontal activation clusters suggesting a compensation mechanism for reduced prefrontal activation during ATD. Thus, serotonin modulates an anterior-to-posterior shift of activation during cognitive switching in older adults. Neural adaptation to serotonin challenge during cognitive control may prove useful in determining cognitive vulnerability in older adults with a predisposition for serontonergic down-regulation (e.g., in vascular or late life depression).",2014,During sham depletion women significantly activated the expected task-relevant brain regions associated with the Switch task including prefrontal and anterior cingulate cortices.,"['older adults', 'Ten healthy women over 55 years']","['serotonin', 'ATD and following a (""placebo"") sham depletion condition']","['task-relevant brain regions', 'posterior (increased) activation clusters', 'task performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",10.0,0.0943021,During sham depletion women significantly activated the expected task-relevant brain regions associated with the Switch task including prefrontal and anterior cingulate cortices.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lamar', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, King's College London, Guy's Campus, London United Kingdom; Section of Brain Maturation, Department of Forensic and Neurodevelopmental Science, Institute of Psychiatry, King's College London, De Crespigny Park, London, United Kingdom; Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Cutter', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brammer', 'Affiliation': ''}, {'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Rubia', 'Affiliation': ''}, {'ForeName': 'Declan G M', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22187'] 1556,32060506,Impact of a 4-hour Introductory eFAST Training Intervention Among Ultrasound-Naïve U.S. Military Medics.,"INTRODUCTION Advances in the portability of ultrasound have allowed it to be increasingly employed at the point of care in austere settings. Battlefield constraints often limit the availability of medical officers throughout the operational environment, leading to increased interest in whether highly portable ultrasound devices can be employed by military medics to enhance their provision of combat casualty care. Data evaluating optimal training for effective medic employment of ultrasound is limited however. This prospective observational cohort study's primary objective was to assess the impact of a 4-hour introductory training intervention on ultrasound-naïve military medic participants' knowledge/performance of the eFAST application. MATERIALS AND METHODS Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM. Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam. Participants were then randomized to receive either conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform. All participants then underwent expert-led, small group hands-on training and practice. Participants' eFAST performance was then assessed with both live and phantom models, followed by a post-course knowledge exam. Concurrently, emergency medicine (EM) resident physician volunteers, serving as standard criterion for trained personnel, underwent the same OSCE assessments, followed by a written exam to assess their baseline eFAST knowledge. Primary outcome measures included (1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score. Secondary outcome measures were time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium. These outcome measures were then compared across medic cohorts and to those of the EM resident physician cohort. RESULTS A total of 34 medics completed the study. After 4 hours of ultrasound training, overall eFAST knowledge among the 34 medics improved from a baseline mean of 27% on the pretest to 83% post-test. For eFAST exam performance, the medics scored an average of 20.8 out of a maximum of 22 points on the OSCE. There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. CONCLUSIONS A 4-hour introductory eFAST training intervention can effectively train conventional military medics to perform the eFAST exam. Online, asynchronously available platforms may effectively mitigate some of the resource requirement burden associated with point-of-care ultrasound training. Future studies evaluating medic eFAST performance on real-world battlefield trauma patients are needed. Skill and knowledge retention must also be assessed for this degradable skill to determine frequency of refresher training when not regularly performed.",2020,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. ","['A total of 34 medics completed the study', 'Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam', 'Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM']","['4-hour Introductory eFAST Training Intervention', 'asynchronous learning', 'conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform', '4-hour introductory training intervention', 'introductory eFAST training intervention']","['time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium', 'overall eFAST knowledge', '1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439581', 'cui_str': 'Asynchronous (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0019065', 'cui_str': 'Hemoperitoneum'}, {'cui': 'C0019064', 'cui_str': 'Hemopericardium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4704780', 'cui_str': 'Extended Focused Assessment with Sonography for Trauma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0579016,"There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. ","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Monti', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Perreault', 'Affiliation': 'Department of Emergency Medicine, Madigan Army Medical Center, 9040 Jackson Avenue, Joint Base Lewis-McChord, Washington 98431.'}]",Military medicine,['10.1093/milmed/usaa014'] 1557,32423126,Effects of Combined Resistance and Power Training on Cognitive Function in Older Women: A Randomized Controlled Trial.,"The present study compared the effects of traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT) on cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels in non-demented, well-functioning, community-dwelling older women. Forty-five older women were randomized into one of three experimental groups: TRT, PTRT, and control group (CG). Cognitive tests explored global cognitive function, short-term memory, and dual-task performance. Serum BDNF levels were assessed at baseline and after the intervention. Exercise sessions were performed twice a week over 22 weeks. In TRT, exercise sessions were based on three sets of 8-10 repetitions at ""difficult"" intensity. In PTRT, the first session was based on PT (three sets of 8-10 repetitions at ""moderate"" intensity), while the second session was similar to the TRT. Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT. Serum BDNF concentrations were not altered by any training protocol. In conclusion, the two RT programs tested in the present trial improved global cognitive function, short-term memory and dual task performance in non-demented, well-functioning, community-dwelling older women. In addition, our findings suggest that mechanisms other than BDNF may be associated with such improvements.",2020,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","['Forty-five older women', 'Older Women', 'non-demented, well-functioning, community-dwelling older women']","['traditional resistance training (TRT) and combined power training (PT) and TRT (PTRT', 'TRT, PTRT, and control group (CG', 'Combined Resistance and Power Training']","['cognitive parameters and serum brain-derived neurotrophic factor (BDNF) levels', 'global cognitive function, short-term memory, and dual-task performance', 'Serum BDNF concentrations', 'global cognitive function, short-term memory and dual task performance', 'Serum BDNF levels', 'Cognitive Function', 'overall cognitive function, short-term memory, and dual-task performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",45.0,0.0217528,"Our analyses indicated that overall cognitive function, short-term memory, and dual-task performance were similarly improved after TRT and PTRT.","[{'ForeName': 'Hélio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Ivan de Oliveira', 'Initials': 'IO', 'LastName': 'Gonçalves', 'Affiliation': 'Center of Health Sciences, University of Mogi das Cruzes, Mogi das Cruzes 08780-911, Brazil.'}, {'ForeName': 'Ricardo Aurélio Carvalho', 'Initials': 'RAC', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Priscila Yukari Sewo', 'Initials': 'PYS', 'LastName': 'Sampaio', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lusa Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, RS 90040-060, Brazil.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Picca', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), Navarra Institute for Health Research (IdiSNA), 31008 Pamplona, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Fondazione Policlinico Universitario ""Agostino Gemelli"" IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Marco Carlos', 'Initials': 'MC', 'LastName': 'Uchida', 'Affiliation': 'Applied Kinesiology Laboratory-AKL, School of Physical Education, University of Campinas, Campinas, SP 13083-851, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17103435'] 1558,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder. METHODS The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response. RESULTS Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms. CONCLUSIONS Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157'] 1559,32078486,Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial.,"Background and Purpose- While combination aspirin and clopidogrel reduces recurrent stroke compared with aspirin alone in patients with transient ischemic attack (TIA) or minor stroke, the effect on disability is uncertain. Methods- The POINT trial (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) randomized patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, myocardial infarction, or vascular death. We performed a post hoc exploratory analysis to examine the effect of treatment on overall disability (defined as modified Rankin Scale score >1) at 90 days, as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results- At 90 days, 188 of 1964 (9.6%) of patients enrolled with TIA and 471 of 2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% versus 14.3%; odds ratio, 0.97 [95% CI, 0.82-1.14]; P =0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% versus 4.0%; odds ratio, 0.73 [95% CI, 0.53-1.01]; P =0.06) and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% versus 7.4%; odds ratio, 0.78 [95% CI, 0.62-0.99]; P =0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% versus 6.0%; odds ratio, 0.74 [95% CI, 0.57-0.96]; P =0.02). In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability. Conclusions- In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, DAPT might reduce stroke-related disability. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00991029.",2020,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","['patients with TIA or minor stroke (National Institutes of Health Stroke Scale score ≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with', 'patients with transient ischemic attack (TIA) or minor stroke']","['DAPT', 'aspirin', 'aspirin and clopidogrel', 'Methods', ' and Purpose', 'aspirin plus clopidogrel versus aspirin alone', 'Conclusions']","['overall disability', 'index event or recurrent stroke', 'female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events', 'composite of stroke, myocardial infarction, or vascular death', 'Overall disability', 'recurrent stroke', 'ischemic stroke, serious adverse events, and major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.144752,"In multivariate analysis, age, subsequent ischemic stroke, serious adverse events, and major bleeding were significantly associated with disability in TIA; for those with stroke, female sex, hypertension, or diabetes mellitus, National Institutes of Health Stroke Scale score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events were associated with disability.","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cucchiara', 'Affiliation': 'From the Department of Neurology, University of Pennsylvania, Philadelphia (B.C.).'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neurosciences, Radiology and Community Health Sciences, University of Calgary, Hotchkiss Brain Institute, AB, Canada (S.B.C.).'}, {'ForeName': 'Joshua Z', 'Initials': 'JZ', 'LastName': 'Willey', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY (J.Z.W.).'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Biros', 'Affiliation': 'Emergency Medicine, University of Minnesota, Minneapolis (M.H.B.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Ross', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA (M.A.R.).'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Emergency Medicine Dean's Office, Dell Medical School, University of Texas-Austin (S.C.J.).""}]",Stroke,['10.1161/STROKEAHA.119.027465'] 1560,22735495,Asthma randomized trial of indoor wood smoke (ARTIS): rationale and methods.,"BACKGROUND Particulate matter (PM) exposures have been linked with poor respiratory health outcomes, especially among susceptible populations such as asthmatic children. Smoke from biomass combustion for residential home heating is an important source of PM in many rural or peri-urban areas in the United States. AIM To assess the efficacy of residential interventions that reduce indoor PM exposure from wood stoves and to quantify the corresponding improvements in quality of life and health outcomes for asthmatic children. DESIGN The asthma randomized trial of indoor wood smoke (ARTIS) study is an in-home intervention study of susceptible children exposed to biomass combustion smoke. Children, ages 7 to 17, with persistent asthma and living in homes that heat with wood stoves were recruited for this three arm randomized placebo-controlled trial. Two household-level intervention strategies, wood stove replacement and air filters, were compared to a sham air filter placebo. Improvement in quality of life of asthmatic children was the primary outcome. Secondary asthma-related health outcomes included peak expiratory flow (PEF) and forced expiratory volume in first second (FEV(1)), biomarkers in exhaled breath condensate, and frequency of asthma symptoms, medication usage, and healthcare utilization. Exposure outcomes included indoor and outdoor PM(2.5) mass, particle counts of several size fractions, and carbon monoxide. DISCUSSION To our knowledge, this was the first randomized trial in the US to utilize interventions targeting residential wood stoves to assess the impact on indoor PM and health outcomes in a susceptible population.",2012,"Exposure outcomes included indoor and outdoor PM(2.5) mass, particle counts of several size fractions, and carbon monoxide. ","['Children, ages 7 to 17, with persistent asthma and living in homes that heat with wood stoves', 'asthmatic children', 'susceptible children exposed to biomass combustion smoke']","['wood stove replacement and air filters, were compared to a sham air filter placebo', 'indoor wood smoke (ARTIS', 'placebo']","['indoor PM and health outcomes', 'peak expiratory flow (PEF) and forced expiratory volume in first second (FEV(1)), biomarkers in exhaled breath condensate, and frequency of asthma symptoms, medication usage, and healthcare utilization', 'indoor and outdoor PM(2.5) mass, particle counts of several size fractions, and carbon monoxide', 'quality of life of asthmatic children', 'quality of life and health outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1268550', 'cui_str': 'Wood stove'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C1268550', 'cui_str': 'Wood stove'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0180861', 'cui_str': 'Air Filters'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1629517', 'cui_str': 'Exhaled breath condensate'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0034380'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",2.0,0.100579,"Exposure outcomes included indoor and outdoor PM(2.5) mass, particle counts of several size fractions, and carbon monoxide. ","[{'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Noonan', 'Affiliation': 'Center for Environmental Health Sciences, Department of Biomedical Sciences, The University of Montana, Missoula, MT 59812, USA. curtis.noonan@umontana.edu'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Ward', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2012.06.006'] 1561,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD). METHODS We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping. RESULTS There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping. CONCLUSIONS Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044'] 1562,22965696,Induction and quantification of prefrontal cortical network plasticity using 5 Hz rTMS and fMRI.,"Neuronal plasticity is crucial for flexible interaction with a changing environment and its disruption is thought to contribute to psychiatric diseases like schizophrenia. High-frequency repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool to increase local excitability of neurons and induce short-time functional reorganization of cortical networks. While this has been shown for the motor system, little is known about the short-term plasticity of networks for executive cognition in humans. We examined 12 healthy control subjects in a crossover study with fMRI after real and sham 5 Hz rTMS to the right dorsolateral prefrontal cortex (DLPFC). During scanning, subjects performed an n-back working memory (WM) task and a flanker task engaging cognitive control. Reaction times during the n-back task were significantly shorter after rTMS than after sham stimulation. RTMS compared with sham stimulation caused no activation changes at the stimulation site (right DLPFC) itself, but significantly increased connectivity within the WM network during n-back and reduced activation in the anterior cingulate cortex during the flanker task. Reduced reaction times after real stimulation support an excitatory effect of high-frequency rTMS. Our findings identified plastic changes in prefrontally connected networks downstream of the stimulation site as the substrate of this behavioral effect. Using a multimodal fMRI-rTMS approach, we could demonstrate changes in cortical plasticity in humans during executive cognition. In further studies this approach could be used to study pharmacological, genetic and disease-related alterations.",2014,"RTMS compared with sham stimulation caused no activation changes at the stimulation site (right DLPFC) itself, but significantly increased connectivity within the WM network during n-back and reduced activation in the anterior cingulate cortex during the flanker task.","['humans during executive cognition', '12 healthy control subjects']","['RTMS', 'n-back working memory (WM) task and a flanker task engaging cognitive control', 'rTMS', 'High-frequency repetitive transcranial magnetic stimulation (rTMS', 'fMRI after real and sham 5 Hz rTMS']",['Reaction times'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",12.0,0.0195634,"RTMS compared with sham stimulation caused no activation changes at the stimulation site (right DLPFC) itself, but significantly increased connectivity within the WM network during n-back and reduced activation in the anterior cingulate cortex during the flanker task.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Esslinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Schüler', 'Affiliation': ''}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sauer', 'Affiliation': ''}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Gass', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Mier', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Ochs', 'Affiliation': ''}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Schulze', 'Affiliation': ''}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Rietschel', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meyer-Lindenberg', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22165'] 1563,32493206,"Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study.","BACKGROUND Calcitonin gene-related peptide (CGRP) has recently been implicated in the pathogenesis of post-traumatic headache (PTH), which raises the prospect for therapeutic use of monoclonal antibodies targeting CGRP or its receptor. Therefore, we decided to assess the efficacy, tolerability, and safety of erenumab for prevention of persistent PTH attributed to mild traumatic brain injury. METHODS A single-center, non-randomized, single-arm, open-label study of erenumab for adults aged 18-65 years with persistent PTH. Patients were assigned to receive 140-mg erenumab monthly by two subcutaneous 1-mL injections, given every 4 weeks for 12 weeks. The primary outcome measure was the mean change in number of monthly headache days of moderate to severe intensity from baseline (4-week pretreatment period) to week 9 through 12. Tolerability and safety endpoints were adverse events (i.e. number and type). RESULTS Eighty-nine of 100 patients completed the open-label trial. At baseline, the mean monthly number of headache days of moderate to severe intensity was 15.7. By week 9 through 12, the number was reduced by 2.8 days. The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15). Of 100 patients who received at least one dose of erenumab, two patients discontinued the treatment regimen due to adverse events. CONCLUSIONS Among patients with persistent PTH, erenumab resulted in a lower frequency of moderate to severe headache days in this 12-week open-label trial. In addition, erenumab was well-tolerated as discontinuations due to adverse events were low. Placebo-controlled randomized clinical trials are needed to adequately evaluate the efficacy and safety of erenumab in patients with persistent PTH. TRIAL REGISTRATION ClinicalTrials.Gov, NCT03974360. Registered on April 17, 2019 - Retrospectively registered.",2020,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"['adults aged 18-65\u2009years with persistent PTH', 'Eighty-nine of 100 patients completed the open-label trial', 'persistent post-traumatic headache attributed to mild traumatic brain injury', 'patients with\xa0persistent PTH']","['Calcitonin gene-related peptide (CGRP', 'erenumab', 'Placebo']","['Efficacy, tolerability, and safety', 'efficacy, tolerability, and safety', 'Tolerability and safety endpoints were adverse events (i.e. number and type', 'mean change in number of monthly headache days of moderate to severe intensity', 'efficacy and safety', 'mean monthly number of headache days of moderate to severe intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.205377,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Haidar Muhsen', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Anna Kristina', 'Initials': 'AK', 'LastName': 'Eigenbrodt', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Eigil Lindekilde', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Amalie Middelboe', 'Initials': 'AM', 'LastName': 'Andersen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Kevin John', 'Initials': 'KJ', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Karoline Bendix', 'Initials': 'KB', 'LastName': 'Bräuner', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mørch-Jessen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Basit', 'Initials': 'B', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Antic', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Casper Emil', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Henrik Winther', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark. henrik.winther.schytz.01@regionh.dk.'}]",The journal of headache and pain,['10.1186/s10194-020-01136-z'] 1564,32422871,The Psychological Effects of a Campus Forest Therapy Program.,"This study aimed to examine the psychological effects of a campus forest therapy program. To evaluate these, pre-test and post-test control group design was employed. A total of 38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control). The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects. The results of this study revealed that participants in the campus forest therapy program group had significantly positive increases in their mood and stress response compared with those of control group participants. In conclusion, the campus forest therapy program is an efficient strategy to provide psychological health benefits to university students and our study can inform decision-makers on the priority of the campus forest program in societal efforts to promote psychological well-being among university students.",2020,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"['university students', '38 participants participated in this study (19 in the campus forest therapy program group, and 19 in control']",[],"['mood and stress response', 'Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",38.0,0.0197324,The Profile of Mood State (POMS) questionnaire and Modified form of the Stress Response Inventory (SRI-MF) were administered to each participant to assess psychological effects.,"[{'ForeName': 'Jin Gun', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Tae Gyu', 'Initials': 'TG', 'LastName': 'Khil', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Youngsuwn', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Kyungja', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Minja', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Therapy, Chungbuk National University, Cheongju 28644, Korea.'}, {'ForeName': 'Won Sop', 'Initials': 'WS', 'LastName': 'Shin', 'Affiliation': 'Department of Forest Sciences, Chungbuk National University, Cheongju 28644, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103409'] 1565,32423038,A Longitudinal Study of a Multicomponent Exercise Intervention with Remote Guidance among Breast Cancer Patients.,"Purpose : Breast cancer patients in treatment suffer from long-term side effects that seriously influence their physical and mental health. The aim of this study was to examine effectiveness of a 12-week multicomponent exercise (ME) with remote guidance intervention on health-related outcomes after one year among breast cancer patients. Methods : In phases I-III, 60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed chemotherapy/postoperative radiotherapy within the previous four months to two years were randomly assigned to 1) multicomponent exercise with remote guidance (ME) and 2) usual care (UC). Eligible participants were approached to assess cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers after one year. Results : The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group. Conclusion : The ME group observed significant differences from the UC group in QOL, muscle strength, cardiopulmonary endurance, and PA participation. These findings suggested that the multicomponent exercise intervention with remote guidance produced long-term health benefits for breast cancer patients.",2020,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group. ","['breast cancer patients', 'Breast Cancer Patients', '60 patients (51.2 ± 7.9 years) with breast cancer (BC) who completed']","['multicomponent exercise (ME) with remote guidance intervention', 'multicomponent exercise intervention', 'Multicomponent Exercise Intervention', 'chemotherapy', 'multicomponent exercise with remote guidance (ME) and 2) usual care (UC', 'postoperative radiotherapy']","['higher vitality-related QOL', 'leg strength and endurance', 'lower physical activity (PA) hindrance', 'mental health-related QOL', 'QOL, muscle strength, cardiopulmonary endurance, and PA participation', 'strength and endurance of upper extremities', 'cancer-related quality of life (QOL), muscle strength, cardiorespiratory endurance, and physical activity (PA) barriers']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0333744,"The results demonstrated that, after one year, the ME group reported higher vitality-related QOL (5.776, 95% confidence interval [CI] 0.987, 10.565, effect size [ES] = 0.360), mental health-related QOL (9.938, 95% CI 4.146, 15.729, ES = 0.512), leg strength and endurance (2.880, CI 1.337, 4.423, ES = 0.557), and strength and endurance of upper extremities (2.745, 95% CI 1.076, 4.415, ES = 0.491) and lower physical activity (PA) hindrance (5.120, 95% CI 1.976, 8.264, ES = 0.486) than the UC group. ","[{'ForeName': 'Xiaosheng', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Xiangren', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Department of Sport and Health, School of Physical Education, Shandong University, Jinan 250061, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': 'College of Physical Education, Shandong Normal University, Jinan 250014, China.'}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'McDonough', 'Affiliation': 'School of Kinesiology, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nuo', 'Initials': 'N', 'LastName': 'Yi', 'Affiliation': 'Department of Kinesiology, College of Health Science University of Wisconsin, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Wenzhen', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Science and Technology, Shandong Institute of Commerce and Technology, Jinan 250103, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17103425'] 1566,22461242,Neural response to emotional stimuli during experimental human endotoxemia.,"Increases in peripheral cytokines during acute inflammation may affect various neuropsychological functions. The aim of this functional magnetic resonance imaging (fMRI) study was to investigate the effects of acute endotoxemia on mood and the neural response to emotionally aversive visual stimuli in healthy human subjects. In a double-blind, randomized crossover study, 18 healthy males received a bolus injection of bacterial lipopolysaccharide (LPS; 0.4 ng/kg) or saline. Plasma levels of pro- and anti-inflammatory cytokines and cortisol as well as mood ratings were analyzed together with the blood-oxygen-level dependent (BOLD) response during the presentation of aversive versus neutral pictures. Endotoxin administration induced pronounced transient increases in plasma levels of TNF-α, IL-1ra, IL-6, IL-10, and cortisol. Positive mood was decreased and state anxiety increased. In addition, activation of right inferior orbitofrontal cortex (OFC) in response to emotional visual stimuli was significantly increased in the LPS condition. Increased prefrontal activation during the presentation of emotional material may reflect enhanced cognitive regulation of emotions as an adaptive response during an acute inflammation. These findings may have implications for the putative role of inflammatory processes in the pathophysiology of depression.",2013,"Endotoxin administration induced pronounced transient increases in plasma levels of TNF-α, IL-1ra, IL-6, IL-10, and cortisol.","['healthy human subjects', '18 healthy males']","['Endotoxin', 'functional magnetic resonance imaging (fMRI', 'bolus injection of bacterial lipopolysaccharide (LPS; 0.4 ng/kg) or saline']","['Positive mood', 'emotional visual stimuli', 'blood-oxygen-level dependent (BOLD) response', 'Increased prefrontal activation', 'state anxiety', 'plasma levels of TNF-α, IL-1ra, IL-6, IL-10, and cortisol', 'activation of right inferior orbitofrontal cortex (OFC', 'peripheral cytokines', 'Plasma levels of pro- and anti-inflammatory cytokines and cortisol as well as mood ratings']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",18.0,0.134975,"Endotoxin administration induced pronounced transient increases in plasma levels of TNF-α, IL-1ra, IL-6, IL-10, and cortisol.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Kullmann', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Jan-Sebastian', 'Initials': 'JS', 'LastName': 'Grigoleit', 'Affiliation': ''}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lichte', 'Affiliation': ''}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kobbe', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rosenberger', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Banner', 'Affiliation': ''}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': ''}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Oberbeck', 'Affiliation': ''}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Forsting', 'Affiliation': ''}, {'ForeName': 'Elke R', 'Initials': 'ER', 'LastName': 'Gizewski', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22063'] 1567,22532661,Randomized controlled trial of high concentration oxygen in suspected community-acquired pneumonia.,"OBJECTIVE To determine whether high concentration oxygen increases the PaCO(2) in the treatment of community-acquired pneumonia. DESIGN Randomized controlled clinical trial in which patients received high concentration oxygen (8 L/min via medium concentration mask) or titrated oxygen (to achieve oxygen saturations between 93 and 95%) for 60 minutes. Transcutaneous CO(2) (PtCO(2)) was measured at 0, 20, 40 and 60 minutes. SETTING The Emergency Departments at Wellington, Hutt and Kenepuru Hospitals. PARTICIPANTS 150 patients with suspected community-acquired pneumonia presenting to the Emergency Department. Patients with chronic obstructive pulmonary disease (COPD) or disorders associated with hypercapnic respiratory failure were excluded. MAIN OUTCOME VARIABLES The primary outcome variable was the proportion of patients with a rise in PtCO(2) ≥4 mmHg at 60 minutes. Secondary outcome variables included the proportion of patients with a rise in PtCO(2) ≥8 mmHg at 60 minutes. RESULTS The proportion of patients with a rise in PtCO(2) ≥4 mmHg at 60 minutes was greater in the high concentration oxygen group, 36/72 (50.0%) vs 11/75 (14.7%), relative risk (RR) 3.4 (95% CI 1.9 to 6.2), P < 0.001. The high concentration group had a greater proportion of patients with a rise in PtCO(2) ≥8 mmHg, 11/72 (15.3%) vs 2/75 (2.7%), RR 5.7 (95% CI 1.3 to 25.0), P = 0.007. Amongst the 74 patients with radiological confirmation of pneumonia, the high concentration group had a greater proportion with a rise in PtCO(2) ≥4 mmHg, 20/35 (57.1%) vs 5/39 (12.8%), RR 4.5 (95% CI 1.9 to 10.6) P < 0.001. CONCLUSIONS We conclude that high concentration oxygen therapy increases the PtCO(2) in patients presenting with suspected community-acquired pneumonia. This suggests that the potential increase in PaCO(2) with high concentration oxygen therapy is not limited to COPD, but may also occur in other respiratory disorders with abnormal gas exchange.",2012,"mmHg at 60 minutes was greater in the high concentration oxygen group, 36/72 (50.0%) vs 11/75 (14.7%), relative risk (RR) 3.4","['150 patients with suspected community-acquired pneumonia presenting to the Emergency Department', 'Patients with chronic obstructive pulmonary disease (COPD) or disorders associated with hypercapnic respiratory failure were excluded', 'The Emergency Departments at Wellington, Hutt and Kenepuru Hospitals', 'patients presenting with suspected community-acquired pneumonia', 'patients with a rise in PtCO(2) ≥4', 'suspected community-acquired pneumonia', '74 patients with radiological confirmation of pneumonia, the high concentration group had a greater proportion with a rise in PtCO(2) ≥4', 'community-acquired pneumonia']","['Transcutaneous CO(2', 'high concentration oxygen (8 L/min via medium concentration mask) or titrated oxygen', 'high concentration oxygen therapy', 'high concentration oxygen']","['PtCO(2', 'proportion of patients with a rise in PtCO(2']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0398353', 'cui_str': 'Type II respiratory failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0453965', 'cui_str': 'Gum boots'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1278440', 'cui_str': 'High concentration oxygen therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",150.0,0.250823,"mmHg at 60 minutes was greater in the high concentration oxygen group, 36/72 (50.0%) vs 11/75 (14.7%), relative risk (RR) 3.4","[{'ForeName': 'Meme', 'Initials': 'M', 'LastName': 'Wijesinghe', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington 6242, New Zealand.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Perrin', 'Affiliation': ''}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,['10.1258/jrsm.2012.110084'] 1568,22451196,Acute effects of single-dose aripiprazole and haloperidol on resting cerebral blood flow (rCBF) in the human brain.,"Antipsychotic drugs act on the dopaminergic system (first-generation antipsychotics, FGA), but some also directly affect serotonergic function (second-generation antipsychotics, SGA) in the brain. Short and long-term effects of these drugs on brain physiology remain poorly understood. Moreover, it remains unclear whether any physiological effect in the brain may be different for FGAs and SGAs. Immediate (+3.30 h) and different effects of single-dose FGA (haloperidol, 3 mg) and a SGA (aripiprazole, 10 mg) on resting cerebral blood flow (rCBF) were explored in the same 20 healthy volunteers using a pulsed continuous arterial spin labeling (pCASL) sequence (1.5T) in a placebo-controlled, repeated measures design. Both antipsychotics increased striatal rCBF but the effect was greater after haloperidol. Both decreased frontal rCBF, and opposite effects of the drugs were observed in the temporal cortex (haloperidol decreased, aripiprazole increased rCBF) and in the posterior cingulate (haloperidol increased, aripiprazole decreased rCBF). Further increases were evident in the insula, hippocampus, and anterior cingulate after both antipsychotics, in the motor cortex following haloperidol and in the occipital lobe the claustrum and the cerebellum after aripiprazole. Further decreases were observed in the parietal and occipital cortices after aripiprazole. This study suggests that early and different rCBF changes are evident following a single-dose of FGA and SGA. The effects occur in healthy volunteers, thus may be independent from any underlying pathology, and in the same regions identified as structurally and functionally altered in schizophrenia, suggesting a possible relationship between antipsychotic-induced rCBF changes and brain alterations in schizophrenia.",2013,"Further increases were evident in the insula, hippocampus, and anterior cingulate after both antipsychotics, in the motor cortex following haloperidol and in the occipital lobe the claustrum and the cerebellum after aripiprazole.","['human brain', '20 healthy volunteers using a', 'healthy volunteers']","['pulsed continuous arterial spin labeling (pCASL) sequence', 'FGA (haloperidol, 3 mg) and a SGA (aripiprazole', 'haloperidol', 'aripiprazole and haloperidol', 'aripiprazole']","['posterior cingulate (haloperidol increased, aripiprazole decreased rCBF', 'striatal rCBF', 'frontal rCBF', 'insula, hippocampus, and anterior cingulate', 'parietal and occipital cortices', 'temporal cortex (haloperidol decreased, aripiprazole increased rCBF', 'resting cerebral blood flow (rCBF']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C3811911', 'cui_str': 'Cuneus'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",20.0,0.0181482,"Further increases were evident in the insula, hippocampus, and anterior cingulate after both antipsychotics, in the motor cortex following haloperidol and in the occipital lobe the claustrum and the cerebellum after aripiprazole.","[{'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Handley', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, United Kingdom. rowena.handley@kcl.ac.uk""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ''}, {'ForeName': 'A A T Simone', 'Initials': 'AA', 'LastName': 'Reinders', 'Affiliation': ''}, {'ForeName': 'Tiago Reis', 'Initials': 'TR', 'LastName': 'Marques', 'Affiliation': ''}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Gorman"", 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Alsop', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Atholl', 'Initials': 'A', 'LastName': 'Johnston', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ''}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ''}, {'ForeName': 'Shitij', 'Initials': 'S', 'LastName': 'Kapur', 'Affiliation': ''}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Dazzan', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21436'] 1569,31916648,"The beneficial health effects of Nigella sativa on Helicobacter pylori eradication, dyspepsia symptoms, and quality of life in infected patients: A pilot study.","The aim of this study was to evaluate the effects of Nigella sativa (N. sativa) in addition to quadruple-therapy on Helicobacter pylori eradication, dyspepsia, biochemical-markers, and quality of life in infected patients. In this double-blind placebo-controlled clinical-trial, 51 H. pylori infected patients with functional dyspepsia were randomly assigned to treatment (quadruple-therapy with 2 g/day N. sativa) or placebo groups (quadruple-therapy with 2 g/day placebo) for 8 weeks. Serum levels of interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde, quality of life, dyspepsia, food-intake, body-weight, and body mass index (BMI) were evaluated at the baseline and at the end of the study. H. pylori eradication was evaluated at the end of the intervention. At the end of the study, H. pylori eradication was more in the N. sativa group compared with the placebo (p = .01). Weight, BMI, and dietary-intake (p < .05) increased significantly as compared with placebo. A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05). The differences of biochemical-markers and dyspepsia between the two groups were not significant. So, N. sativa supplementation with medical treatment may have beneficial effects on H. pylori eradication, weight, BMI, dietary-intake, and quality of life in infected patients.",2020,A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05).,"['infected patients', '51 H. pylori infected patients with functional dyspepsia']","['placebo', 'placebo groups (quadruple-therapy with 2\u2009g/day placebo', 'Nigella sativa', 'Nigella sativa (N. sativa']","['Helicobacter pylori eradication, dyspepsia symptoms, and quality of life', 'Weight, BMI, and dietary-intake', 'pylori eradication', ""patients' quality of life"", 'Helicobacter pylori eradication, dyspepsia, biochemical-markers, and quality of life', 'H. pylori eradication, weight, BMI, dietary-intake, and quality of life', 'H. pylori eradication', 'Serum levels of interleukin-8 (IL-8), high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde, quality of life, dyspepsia, food-intake, body-weight, and body mass index (BMI', 'biochemical-markers and dyspepsia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",,0.184888,A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05).,"[{'ForeName': 'Mahvash', 'Initials': 'M', 'LastName': 'Alizadeh-Naini', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Yousefnejad', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Hejazi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6610'] 1570,31399440,Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials.,"OBJECTIVE The impact of major affective disorders on the effectiveness of diabetes prevention programs at promoting health behaviors has not been established. We investigated whether depression modifies the effectiveness of two pragmatic diabetes prevention programs at promoting increased physical activity. RESEARCH DESIGN AND METHODS This study pooled data from two cluster randomized controlled trials (Walking Away from Type 2 Diabetes and Let's Prevent Type 2 Diabetes) that included individuals at high risk of type 2 diabetes who were recruited from primary care. The trials used very similar intervention methods to promote physical activity and had annual follow-up over a 36-month period. Depressive symptoms were measured by the Hospital Anxiety and Depression Scale, and physical activity was measured by a piezoelectric pedometer (Let's Prevent Type 2 Diabetes) or an accelerometer (Walking Away from Type 2 Diabetes) and expressed as steps per day. RESULTS This analysis included 1,163 individuals (571 control, 592 intervention) who had concurrent baseline and follow-up data for ambulatory activity, depression, and anxiety. The median depression score was 3 at baseline; 11% of individuals were classified as having mild to severe depression. Those with no depressive symptoms at baseline or during follow-up increased their ambulatory activity by 592 steps per day ( P < 0.001); this effect decayed by 88 steps per day (95% CI 21, 155) for every additional depressive symptom score at baseline, and each increase in the depressive symptom score between baseline and follow-up further attenuated the intervention effect by 99 steps per day (95% CI 2, 196). CONCLUSIONS Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.",2019,Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.,"['1,163 individuals (571 control, 592 intervention) who had concurrent baseline and follow-up data for ambulatory activity, depression, and anxiety', 'Primary Care', ""Type 2 Diabetes and Let's Prevent Type 2 Diabetes) that included individuals at high risk of type 2 diabetes who were recruited from primary care""]","['piezoelectric pedometer ', 'diabetes prevention programs']","['Depressive symptoms', 'ambulatory activity', 'depressive symptom score', 'median depression score', 'Hospital Anxiety and Depression Scale, and physical activity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",1163.0,0.137956,Both depressive symptom burden at baseline and change in this burden are associated with a graded reduction in the effectiveness of diabetes prevention programs at increasing physical activity in primary care.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K. ty20@le.ac.uk.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, U.K.'}]",Diabetes care,['10.2337/dc19-0400'] 1571,31399442,Effect of Linagliptin on Cognitive Performance in Patients With Type 2 Diabetes and Cardiorenal Comorbidities: The CARMELINA Randomized Trial.,"OBJECTIVE Type 2 diabetes is associated with cognitive dysfunction and an increased dementia risk, particularly in individuals with concomitant cardiovascular and/or kidney disease. Incretin therapies may modulate this risk via glycemic and nonglycemic pathways. We explored if the dipeptidyl peptidase 4 inhibitor linagliptin could prevent cognitive decline in people with type 2 diabetes with cardiorenal disease. RESEARCH DESIGN AND METHODS The CArdiovascular and Renal Microvascular outcomE study with LINAgliptin (CARMELINA)-COG substudy was an integral part of CARMELINA (NCT01897532) that randomized participants with cardiorenal disease to linagliptin 5 mg or placebo once daily (1:1), in addition to standard of care. The primary cognitive outcome was the occurrence of accelerated cognitive decline at the end of treatment, defined as a regression-based index score ≤16th percentile on the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning and analyzed in participants with a baseline MMSE ≥24. Effects across subgroups by baseline factors, as well as absolute cognitive changes, were also assessed. RESULTS Of the 6,979 participants in CARMELINA, CARMELINA-COG included 1,545 (mean ± SD age, 68 ± 8 years; MMSE, 28.3 ± 1.7; estimated glomerular filtration rate, 52 ± 23 mL/min/1.73 m 2 ; and HbA 1c , 7.8 ± 0.9% [61.4 ± 10.1 mmol/mol]). Over a median treatment duration of 2.5 years, accelerated cognitive decline occurred in 28.4% (linagliptin) vs. 29.3% (placebo) (odds ratio 0.96 [95% CI 0.77, 1.19]). Consistent effects were observed across subgroups by baseline characteristics. Absolute cognitive performance changes were also similar between treatment groups. CONCLUSIONS In a large international cardiovascular outcome trial in people with type 2 diabetes and cardiorenal disease, linagliptin did not modulate cognitive decline over 2.5 years.",2019,"Absolute cognitive performance changes were also similar between treatment groups. ","['people with type 2 diabetes and cardiorenal disease', 'individuals with concomitant cardiovascular and/or kidney disease', 'randomized participants with cardiorenal disease to', 'Patients With Type 2 Diabetes and Cardiorenal Comorbidities', '6,979 participants in CARMELINA', 'people with type 2 diabetes with cardiorenal disease']","['Linagliptin', 'LINAgliptin', 'linagliptin 5 mg or placebo', 'dipeptidyl peptidase 4 inhibitor linagliptin', 'linagliptin']","['accelerated cognitive decline', 'Absolute cognitive performance changes', 'occurrence of accelerated cognitive decline at the end of treatment, defined as a regression-based index score ≤16th percentile on the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning', 'cognitive decline', 'Cognitive Performance']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.508857,"Absolute cognitive performance changes were also similar between treatment groups. ","[{'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Biessels', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands g.j.biessels@umcutrecht.nl.'}, {'ForeName': 'Chloë', 'Initials': 'C', 'LastName': 'Verhagen', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'Janssen', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'van den Berg', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center, Dallas, TX.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Therapeutic Area Cardiometabolism, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Passera', 'Affiliation': 'HMS Analytical Software GmbH, Sulzbach, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim, Biberach, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0783'] 1572,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models. METHODS We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656. FINDINGS Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early. INTERPRETATION In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies. FUNDING Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9'] 1573,31425780,Phase 2 clinical study of delgocitinib ointment in pediatric patients with atopic dermatitis.,"BACKGROUND Topical delgocitinib (JTE-052), a novel Janus kinase inhibitor, had been shown to be clinically effective in adults with atopic dermatitis (AD). However, the efficacy of topical delgocitinib in pediatric patients with AD remained unclear. OBJECTIVE We sought to evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD. METHODS In this phase 2 clinical study (JapicCTI-173553) Japanese patients aged 2 through 15 years with AD were randomized in a 1:1:1 ratio to receive 0.25% or 0.5% delgocitinib ointment or vehicle ointment twice daily for 4 weeks. The primary efficacy end point was the percentage change from baseline in the modified Eczema Area and Severity Index score at the end of treatment (EOT). RESULTS At EOT, modified Eczema Area and Severity Index scores in both delgocitinib groups were significantly reduced compared with that in the vehicle group. The least-squares mean percentage change from baseline was -54.2% in the 0.25% group and -61.8% in the 0.5% group versus -4.8% in the vehicle group (P < .001 for both comparisons). Similarly, all other efficacy parameters, including Investigator's Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group at EOT. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported. CONCLUSIONS Delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. These study results indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.",2019,"At EOT, the mEASI scores in both delgocitinib groups were significantly reduced compared with those in the vehicle group.","['pediatric patients with AD remained unclear', 'adult patients with atopic dermatitis (AD', 'Japanese patients aged 2 through 15 years with AD', 'pediatric patients with atopic dermatitis', 'pediatric patients with AD']","['delgocitinib ointment', 'Delgocitinib ointment', 'Topical delgocitinib (JTE-052', 'topical delgocitinib']","['tolerated', 'Adverse events', 'clinical signs and symptoms', 'mEASI scores', ""Investigator's Global Assessment and pruritus scores"", 'efficacy and safety', 'modified Eczema Area and Severity Index (mEASI) score at the end of treatment (EOT']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4508502', 'cui_str': 'JTE-052'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.055258,"At EOT, the mEASI scores in both delgocitinib groups were significantly reduced compared with those in the vehicle group.","[{'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Oda', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco, Tokyo, Japan. Electronic address: takeshi.nagata@jt.com.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.004'] 1574,399624,Single-layer mass closure of major laparotomies by continuous suturing.,,1979,,[],['Single-layer mass closure of major laparotomies by continuous suturing'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441504', 'cui_str': 'Mass closure (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",[],,0.0134154,,"[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pollock', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Greenall', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1575,31855909,Changes on Tendon Stiffness and Clinical Outcomes in Athletes Are Associated With Patellar Tendinopathy After Eccentric Exercise.,"OBJECTIVE Eccentric exercise is commonly used as a form of loading exercise for individuals with patellar tendinopathy. This study investigated the change of mechanical properties and clinical outcomes and their interrelationships after a 12-week single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT). DESIGN Randomized controlled trial. SETTING Outpatient clinic of a university. PARTICIPANTS Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months were randomized into exercise and combined groups. INTERVENTIONS The exercise group received a 12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT in the initial 6 weeks. MAIN OUTCOME MEASURES Tendon stiffness and strain were examined using ultrasonography and dynamometry. Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score were used to assess pain and dysfunction. These parameters were measured at preintervention and postintervention. RESULTS Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed. Significant correlations between changes in tendon stiffness and VISA-p score (ρ = -0.58, P = 0.05); alteration in tendon strain, pain intensity (ρ = -0.63, P = 0.03); and VISA-p score (ρ = 0.60, P = 0.04) were detected after the exercise program. CONCLUSIONS Eccentric exercise-induced modulation on tendon mechanical properties and clinical symptoms are associated in athletes with patellar tendinopathy.",2020,"RESULTS Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","['Outpatient clinic of a university', 'athletes with patellar tendinopathy', 'individuals with patellar tendinopathy', 'Thirty-four male in-season athletes with patellar tendinopathy for more than 3 months']","['Eccentric exercise', 'single-legged decline-board exercise with and without extracorporeal shockwave therapy (ESWT', 'Eccentric exercise-induced modulation', '12-week single-legged decline-squat exercise, and the combined group performed an identical exercise program in addition to a weekly session of ESWT']","['Tendon Stiffness and Clinical Outcomes', 'pain and dysfunction', 'Visual analog scale and Victoria Institute of Sports Assessment-patella (VISA-p) score', 'Tendon stiffness and strain', 'reduction of intensity of pain', 'tendon stiffness and VISA-p score', 'tendon stiffness', 'tendon mechanical properties and clinical symptoms', 'tendon strain', 'tendon strain, pain intensity']","[{'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030647', 'cui_str': 'Kneecap'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0434303', 'cui_str': 'Tendon strain (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0305104,"RESULTS Significant time effect but no significant group effect on the outcome measures; significant reduction in tendon stiffness (P = 0.02) and increase in tendon strain (P = 0.00); and reduction of intensity of pain (P = 0.00) and dysfunction (P = 0.00) were observed.","[{'ForeName': 'Wai-Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Gabriel Yin-Fat', 'Initials': 'GY', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Physical Therapy, Luoyang Orthopedic Hospital of Henan Province, Luoyang, Henan, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Masci', 'Affiliation': 'Pure Sports Medicine, London, United Kingdom.'}, {'ForeName': 'Siu-Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000562'] 1576,31533913,"Effect of Empagliflozin on Endothelial Function in Patients With Type 2 Diabetes and Cardiovascular Disease: Results from the Multicenter, Randomized, Placebo-Controlled, Double-Blind EMBLEM Trial.",,2019,,['Patients With Type 2 Diabetes and Cardiovascular Disease'],"['Placebo', 'Empagliflozin']",['Endothelial Function'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}]",,0.56596,,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan tanakaa2@cc.saga-u.ac.jp node@cc.saga-u.ac.jp.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Shimabukuro', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Machii', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Teragawa', 'Affiliation': 'Department of Cardiovascular Medicine, JR Hiroshima Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Kosuke R', 'Initials': 'KR', 'LastName': 'Shima', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Hisauchi', 'Affiliation': 'Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, Mibu, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Yamaoka-Tojo', 'Affiliation': 'Department of Rehabilitation, Kitasato University School of Allied Health Sciences, Sagamihara, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Ikehara', 'Affiliation': 'Clinical Research and Quality Management Center, University of the Ryukyus Hospital, Nishihara, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus, Nishihara, Japan.'}, {'ForeName': 'Yukihito', 'Initials': 'Y', 'LastName': 'Higashi', 'Affiliation': 'Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-1177'] 1577,21938758,Dynamically changing effects of corticosteroids on human hippocampal and prefrontal processing.,"Stress has a powerful impact on memory. Corticosteroids, released in response to stress, are thought to mediate, at least in part, these effects by affecting neuronal plasticity in brain regions involved in memory formation, including the hippocampus and prefrontal cortex. Animal studies have delineated aspects of the underlying physiological mechanisms, revealing rapid, nongenomic effects facilitating synaptic plasticity, followed several hours later by a gene-mediated suppression of this plasticity. Here, we tested the hypothesis that corticosteroids would also rapidly upregulate and slowly downregulate brain regions critical for episodic memory formation in humans. To target rapid and slow effects of corticosteroids on neural processing associated with memory formation, we investigated 18 young, healthy men who received 20 mg hydrocortisone either 30 or 180 min before a memory encoding task in a double-blind, placebo-controlled, counter-balanced, crossover design. We used functional MRI to measure neural responses during these memory encoding sessions, which were separated by a month. Results revealed that corticosteroids' slow effects reduced both prefrontal and hippocampal responses, while no significant rapid actions of corticosteroids were observed. Thereby, this study provides initial evidence for dynamically changing corticosteroid effects on brain regions involved in memory formation in humans.",2012,"Here, we tested the hypothesis that corticosteroids would also rapidly upregulate and slowly downregulate brain regions critical for episodic memory formation in humans.","['18 young, healthy men who received 20 mg', 'humans']","['hydrocortisone either 30 or 180 min before a memory encoding task in a double-blind, placebo', 'corticosteroids']","['human hippocampal and prefrontal processing', 'prefrontal and hippocampal responses', 'rapid actions of corticosteroids']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",18.0,0.115537,"Here, we tested the hypothesis that corticosteroids would also rapidly upregulate and slowly downregulate brain regions critical for episodic memory formation in humans.","[{'ForeName': 'Marloes J A G', 'Initials': 'MJ', 'LastName': 'Henckens', 'Affiliation': 'Department of Memory and Emotion, Centre for Cognitive Neuroimaging, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, The Netherlands. m.henckens@donders.ru.nl'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Pu', 'Affiliation': ''}, {'ForeName': 'Erno J', 'Initials': 'EJ', 'LastName': 'Hermans', 'Affiliation': ''}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Joëls', 'Affiliation': ''}, {'ForeName': 'Guillén', 'Initials': 'G', 'LastName': 'Fernández', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21409'] 1578,32422244,"Implementation of basic life support training for school children: Online education for potential instructors? Results of a cluster randomised, controlled, non-inferiority trial.","AIM OF THE STUDY Comprehensive training of the population in basic life support (BLS) increases the chance of survival in cardiac arrest. To implement BLS trainings at schools a high number of instructors will be needed. This non-inferiority study investigated, if online education is effective to prepare instructors to teach BLS compared to face-to-face education. METHODS A cluster randomised, controlled, single blinded study was performed in 2018 in Hamburg, Germany. A mixed group of potential instructors were allocated alternately to either the intervention or control group and participated in a four-hour instructor training. The instructor training of the control group was realised by trained educators. The intervention group participated in a self-regulated online training with hands-on training supported by peers. Instructors provided BLS training for high school students. The primary endpoint was a mean score in the BLS skills assessment of the students. The secondary endpoint was teaching effectiveness of the instructors. RESULTS BLS assessments of 808 students of 46 classes, who were taught by 74 instructors could be analysed. The students trained by interventional instructors achieved 0.14 points less (95% CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48). The non-inferiority could not be confirmed. The teaching performance in the intervention group was better in some aspects compared to the control group. CONCLUSION Integrating all results of this study, online education may be an effective alternative to prepare potential BLS instructors. Using free online courses, motivated persons can independently acquire necessary skills to become instructors and autonomously realise low cost BLS trainings at schools.",2020,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"['808 students of 46 classes, who were taught by 74 instructors could be analysed', '2018 in Hamburg, Germany', 'high school students', 'school children']","['Basic life support training', 'BLS training', 'self-regulated online training with hands-on training supported by peers', 'intervention or control group and participated in a four-hour instructor training']","['mean score in the BLS skills assessment of the students', 'teaching effectiveness of the instructors']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",,0.042077,The students trained by interventional instructors achieved 0.14 points less (95%-CI: -0.27 to 0.56) compared to students trained by control instructors (9.34 vs. 9.48).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Napp', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Kosan', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hoffend', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Breitfeld', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'Department of Anaesthesiology, University Medical Center Hamburg-Eppendorf, Martini-Str. 52, 20246 Hamburg, Germany. Electronic address: st.beck@uke.de.'}]",Resuscitation,['10.1016/j.resuscitation.2020.04.041'] 1579,399634,Influence of depth of suture bite on integrity of single-layer large-bowel anastomoses: controlled trial.,,1979,,[],['suture bite'],[],[],"[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0005658', 'cui_str': 'Bites'}]",[],,0.058882,,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Greenall', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pollock', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1580,399639,Randomized clinical trials in cancer chemotherapy.,,1979,,[],[],[],[],[],[],,0.237652,,"[{'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Razis', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1581,22331673,The dynamics of change in striatal activity following updating training.,"Increases in striatal activity have been suggested to mediate training-related improvements in working-memory ability. We investigated the temporal dynamics of changes in task-related brain activity following training of working memory. Participants in an experimental group and an active control group, trained on easier tasks of a constant difficulty in shorter sessions than the experimental group, were measured before, after about 1 week, and after more than 50 days of training. In the experimental group an initial increase of working-memory related activity in the functionally defined right striatum and anatomically defined right and left putamen was followed by decreases, resulting in an inverted u-shape function that relates activity to training over time. Activity increases in the striatum developed slower in the active control group, observed at the second posttest after more than 50 days of training. In the functionally defined left striatum, initial activity increases were maintained after more extensive training and the pattern was similar for the two groups. These results shed new light on the relation between activity in the striatum (especially the putamen) and the effects of working memory training, and illustrate the importance of multiple measurements for interpreting effects of training on regional brain activity.",2013,"In the experimental group an initial increase of working-memory related activity in the functionally defined right striatum and anatomically defined right and left putamen was followed by decreases, resulting in an inverted u-shape function that relates activity to training over time.",[],[],"['Activity', 'striatal activity', 'working-memory related activity']",[],[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0201899,"In the experimental group an initial increase of working-memory related activity in the functionally defined right striatum and anatomically defined right and left putamen was followed by decreases, resulting in an inverted u-shape function that relates activity to training over time.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Department of Experimental Psychology and Ghent Institute for Functional and Metabolic Imaging, Ghent University, Henri Dunantlaan 2, 9000 Gent, Belgium. simone.kuhn@ugent.be'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schmiedek', 'Affiliation': ''}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Noack', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wenger', 'Affiliation': ''}, {'ForeName': 'Nils C', 'Initials': 'NC', 'LastName': 'Bodammer', 'Affiliation': ''}, {'ForeName': 'Ulman', 'Initials': 'U', 'LastName': 'Lindenberger', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövden', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22007'] 1582,31398997,Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc. ) in the prophylactic treatment of migraine.,"BACKGROUND Previous studies have shown an analgesic effect of ginger in the acute treatment of migraine, and there is anecdotal evidence of its efficacy in migraine prophylaxis. OBJECTIVE This study aimed to evaluate the potential of ginger to prevent migraine attacks. METHODS This double-blind, placebo-controlled randomized clinical trial took place at the Headache Clinic, Universidade Federal de Minas Gerais (Belo Horizonte, Minas Gerais, Brazil), involving 107 patients. Only subjects diagnosed with episodic migraine, aged between 18 and 60 years old, and who were not taking any prophylactic medication, were enrolled in the study. After one month of observation, subjects selected for the study were randomized 1:1 into placebo and treatment groups. Patients received capsules three times per day of 200 mg of dry extract of ginger (5% active ingredient) or placebo (cellulose) for three months. Visits were performed monthly and the patients were asked to fill in a migraine diary. The adherence to treatment was evaluated by counting capsules. RESULTS The percentage of patients who responded to treatment (i.e. a reduction of 50% in the number of migraine attacks at the end of treatment) did not differ between the groups. There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups. CONCLUSIONS Ginger provides no greater benefit in the prophylactic treatment of migraine when compared to placebo. This trial is registered at ClinicalTrials.gov (NCT02570633).",2020,"There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups. ","['Headache Clinic, Universidade Federal de Minas Gerais', '107 patients', 'Only subjects diagnosed with episodic migraine, aged between 18 and 60 years old, and who were not taking any prophylactic medication, were enrolled in the study']","['placebo', 'ginger ( Zingiber officinale Rosc. ', 'dry extract of ginger (5% active ingredient) or placebo (cellulose']","['number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks', 'number of migraine attacks']","[{'cui': 'C3839733', 'cui_str': 'Headache clinic (environment)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C1720167', 'cui_str': 'Dry extract (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]",107.0,0.513998,"There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups. ","[{'ForeName': 'Laís Bhering', 'Initials': 'LB', 'LastName': 'Martins', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Maria Dos Santos', 'Initials': 'AMDS', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Nayara Mussi', 'Initials': 'NM', 'LastName': 'Monteze', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Jenneffer Rayane Braga', 'Initials': 'JRB', 'LastName': 'Tibaes', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Matheus Henrique Alves', 'Initials': 'MHA', 'LastName': 'Amaral', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Rodrigo Santiago', 'Initials': 'RS', 'LastName': 'Gomez', 'Affiliation': 'University Hospital, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Santa Casa BH Ensino e Pesquisa, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Adaliene Versiani Matos', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Nursing School, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419869319'] 1583,22076808,Impairment of executive performance after transcranial magnetic modulation of the left dorsal frontal-striatal circuit.,"The dorsal frontal-striatal circuit is implicated in executive functions, such as planning. The Tower of London task, a planning task, in combination with off-line low-frequency repetitive transcranial magnetic stimulation (rTMS), was used to investigate whether interfering with dorsolateral prefrontal function would modulate executive performance, mimicking dorsal frontal-striatal dysfunction as found in neuropsychiatric disorders. Eleven healthy controls (seven females; mean age 25.5 years) were entered in a cross-over design: two single-session treatments of low-frequency (1 Hz) rTMS (vs. sham rTMS) for 20 min on the left dorsolateral prefrontal cortex (DLPFC). Directly following the off-line rTMS treatment, the Tower of London task was performed during MRI measurements. The low-frequency rTMS treatment impaired performance, but only when the subjects had not performed the task before: we found a TMS condition-by-order effect, such that real TMS treatment in the first session led to significantly more errors (P = 0.032), whereas this TMS effect was not present in subjects who received real TMS in the second session. At the neural level, rTMS resulted in decreased activation during the rTMS versus sham condition in prefrontal brain regions (i.e., premotor, dorsolateral prefrontal and anterior prefrontal cortices) and visuospatial brain regions (i.e., precuneus/cuneus and inferior parietal cortex). The results show that low-frequency off-line rTMS on the DLPFC resulted in decreased task-related activations in the frontal and visuospatial regions during the performance of the Tower of London task, with a behavioral effect only when task experience is limited.",2013,"The results show that low-frequency off-line rTMS on the DLPFC resulted in decreased task-related activations in the frontal and visuospatial regions during the performance of the Tower of London task, with a behavioral effect only when task experience is limited.",['Eleven healthy controls (seven females; mean age 25.5 years'],"['low-frequency (1 Hz) rTMS (vs. sham rTMS', 'planning task, in combination with off-line low-frequency repetitive transcranial magnetic stimulation (rTMS', 'real TMS', 'rTMS']","['executive performance', 'TMS effect', 'prefrontal brain regions (i.e., premotor, dorsolateral prefrontal and anterior prefrontal cortices) and visuospatial brain regions (i.e., precuneus/cuneus and inferior parietal cortex']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}]",11.0,0.0117958,"The results show that low-frequency off-line rTMS on the DLPFC resulted in decreased task-related activations in the frontal and visuospatial regions during the performance of the Tower of London task, with a behavioral effect only when task experience is limited.","[{'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Psychiatry, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Helene C', 'Initials': 'HC', 'LastName': 'Van Gorsel', 'Affiliation': ''}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': ''}, {'ForeName': 'Ysbrand D', 'Initials': 'YD', 'LastName': 'Van Der Werf', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21443'] 1584,31399378,"Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial.","BACKGROUND Patients who are immunocompromised because of malignancy have an increased risk of herpes zoster and herpes zoster-related complications. We aimed to investigate the efficacy and safety of an inactivated varicella zoster virus (VZV) vaccine for herpes zoster prevention in patients with solid tumour or haematological malignancies. METHODS This phase 3, two-arm, randomised, double-blind, placebo-controlled, multicentre trial with an adaptive design was done in 329 centres across 40 countries. The trial included adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy. Patients were randomly assigned (1:1) to receive four doses of VZV vaccine inactivated by γ irradiation or placebo approximately 30 days apart. The patients, investigators, trial site staff, clinical adjudication committee, and sponsor's clinical and laboratory personnel were masked to the group assignment. The primary efficacy endpoint was herpes zoster incidence in patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of inactivated VZV vaccine or placebo). The primary safety endpoint was serious adverse events up to 28 days after the fourth dose in patients with solid tumour malignancies receiving chemotherapy. Safety endpoints were assessed in all patients who received at least one dose of inactivated VZV vaccine or placebo and had follow-up data. This trial is registered (NCT01254630 and EudraCT 2010-023156-89). FINDINGS Between June 27, 2011, and April 11, 2017, 5286 patients were randomly assigned to receive VZV vaccine inactivated by γ irradiation (n=2637) or placebo (n=2649). The haematological malignancy arm was terminated early because of evidence of futility at a planned interim analysis; therefore, all prespecified haematological malignancy endpoints were deemed exploratory. In patients with solid tumour malignancies in the modified intention-to-treat population, confirmed herpes zoster occurred in 22 of 1328 (6·7 per 1000 person-years) VZV vaccine recipients and in 61 of 1350 (18·5 per 1000 person-years) placebo recipients. Estimated vaccine efficacy against herpes zoster in patients with solid tumour malignancies was 63·6% (97·5% CI 36·4 to 79·1), meeting the prespecified success criterion. In patients with solid tumour malignancies, serious adverse events were similar in frequency across treatment groups, occurring in 298 (22·5%) of 1322 patients who received the vaccine and in 283 (21·0%) of 1346 patients who received placebo (risk difference 1·5%, 95% CI -1·7 to 4·6). Vaccine-related serious adverse events were less than 1% in each treatment group. Vaccine-related injection-site reactions were more common in the vaccine group than in the placebo group. In the haematological malignancy group, VZV vaccine was well tolerated and estimated vaccine efficacy against herpes zoster was 16·8% (95% CI -17·8 to 41·3). INTERPRETATION The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies. FUNDING Merck & Co, Inc.",2019,"The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies. ","['patients with solid tumour malignancies receiving', 'Between June 27, 2011, and April 11, 2017', 'patients with solid tumour malignancies', '329 centres across 40 countries', '5286 patients', 'patients with haematological malignancies', 'patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of', 'adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy', 'immunocompromised patients with malignancies', 'patients with solid tumour or haematological malignancies']","['chemotherapy', 'inactivated varicella zoster virus vaccine', 'placebo', 'VZV vaccine inactivated by γ irradiation or placebo', 'inactivated varicella zoster virus (VZV) vaccine', 'VZV vaccine inactivated by γ irradiation (n=2637) or placebo', 'inactivated VZV vaccine or placebo']","['serious adverse events', 'tolerated and estimated vaccine efficacy against herpes zoster', 'Vaccine-related injection-site reactions', 'Safety and efficacy', 'herpes zoster incidence', 'herpes zoster', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1346.0,0.768375,"The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies. ","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Department of Medicine, Chicago, IL, USA. Electronic address: kmullane@medicine.bsd.uchicago.edu.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Morrison', 'Affiliation': 'University of Minnesota, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Camacho', 'Affiliation': 'Oncology Consultants, Houston, TX, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Arvin', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Durrand', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Campbell', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ivan S F', 'Initials': 'ISF', 'LastName': 'Chan', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Parrino', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Popmihajlov', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Paula W', 'Initials': 'PW', 'LastName': 'Annunziato', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30310-X'] 1585,21823209,Memory training impacts short-term changes in aging white matter: a longitudinal diffusion tensor imaging study.,"A growing body of research indicates benefits of cognitive training in older adults, but the neuronal mechanisms underlying the effect of cognitive intervention remains largely unexplored. Neuroimaging methods are sensitive to subtle changes in brain structure and show potential for enhancing our understanding of both aging- and training-related neuronal plasticity. Specifically, studies using diffusion tensor imaging (DTI) suggest substantial changes in white matter (WM) in aging, but it is not known whether cognitive training might modulate these structural alterations. We used tract-based spatial statistics (TBSS) optimized for longitudinal analysis to delineate the effects of 8 weeks intensive memory training on WM microstructure. 41 participants (mean age 61 years) matched for age, sex and education were randomly assigned to an intervention or control group. All participants underwent MRI-scanning and neuropsychological assessments at the beginning and end of the study. Longitudinal analysis across groups revealed significant increase in frontal mean diffusivity (MD), indicating that DTI is sensitive to WM structural alterations over a 10-week interval. Further, group analysis demonstrated positive effects of training on the short-term changes. Participants in the training group showed a relative increase in fractional anisotropy (FA) compared with controls. Further, a significant relationship between memory improvement and change in FA was found, suggesting a possible functional significance of the reported changes. The training effect on FA seemed to be driven by a relative decrease in radial diffusivity, which might indicate a role for myelin-related processes in WM plasticity.",2012,"Longitudinal analysis across groups revealed significant increase in frontal mean diffusivity (MD), indicating that DTI is sensitive to WM structural alterations over a 10-week interval.","['aging white matter', 'older adults', '41 participants (mean age 61 years) matched for age, sex and education']","['tract-based spatial statistics (TBSS', 'diffusion tensor imaging (DTI', 'Memory training', 'cognitive training']","['fractional anisotropy (FA', 'frontal mean diffusivity (MD', 'memory improvement and change in FA']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0682708'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0282411,"Longitudinal analysis across groups revealed significant increase in frontal mean diffusivity (MD), indicating that DTI is sensitive to WM structural alterations over a 10-week interval.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engvig', 'Affiliation': 'Center for the Study of Human Cognition, Department of Psychology, University of Oslo, Oslo, Norway. andreas.engvig@gmail.com'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Fjell', 'Affiliation': ''}, {'ForeName': 'Lars T', 'Initials': 'LT', 'LastName': 'Westlye', 'Affiliation': ''}, {'ForeName': 'Torgeir', 'Initials': 'T', 'LastName': 'Moberget', 'Affiliation': ''}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Sundseth', 'Affiliation': ''}, {'ForeName': 'Vivi Agnete', 'Initials': 'VA', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Kristine B', 'Initials': 'KB', 'LastName': 'Walhovd', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21370'] 1586,31399438,Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial.,"OBJECTIVE To explore gallbladder- and biliary tract-related events reported for the liraglutide and placebo groups in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial. RESEARCH DESIGN AND METHODS LEADER was an international, randomized, double-blind, controlled cardiovascular (CV) outcomes trial. Participants with type 2 diabetes at high risk for CV events ( n = 9,340) were randomized 1:1 to receive either liraglutide (≤1.8 mg daily; n = 4,668) or placebo ( n = 4,672), with both groups also receiving standard care (treatment period: 3.5-5 years). Acute gallstone disease was a medical event of special interest. This post hoc analysis categorized captured events of acute gallbladder or biliary disease into four groups: uncomplicated gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction. Time to first event by treatment group was analyzed using Cox regression. RESULTS There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001). Similar trends were observed for each of the four categories of gallbladder- or biliary tract-related events. Cholecystectomy was performed more frequently in liraglutide-treated patients (HR 1.56; 95% CI 1.10, 2.20; P = 0.013) but for similar proportions of the patients who experienced gallbladder- or biliary tract-related events (57% with liraglutide vs. 59% with placebo). CONCLUSIONS Although LEADER was not specifically designed to assess acute gallbladder or biliary disease, the trial showed an increased risk of gallbladder- or biliary tract-related events with liraglutide versus placebo, which appeared to be consistent across four categories of these events. Further studies should investigate the relevant mechanisms.",2019,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001).","['Participants with type 2 diabetes at high risk for CV events ( n = 9,340', 'Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Liraglutide', 'liraglutide', 'liraglutide and placebo', 'placebo', 'Placebo', 'liraglutide versus placebo']","['gallbladder- or biliary tract-related events', 'risk of acute gallbladder or biliary disease', 'gallbladder stones, complicated gallbladder stones, cholecystitis, and biliary obstruction', 'Acute Gallbladder or Biliary Disease']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0005423', 'cui_str': 'Biliary System'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0947622', 'cui_str': 'Cholecystolithiasis'}, {'cui': 'C0008325', 'cui_str': 'Gallbladder Inflammation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",4672.0,0.459866,"There was an increased risk of acute gallbladder or biliary disease with liraglutide versus placebo ( n = 141 of 4,668 vs. n = 88 of 4,672 patients, respectively; hazard ratio [HR] 1.60; 95% CI 1.23, 2.09; P < 0.001).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Muus Ghorbani', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0415'] 1587,21915941,Characterization of neuromagnetic brain rhythms over time scales of minutes using spatial independent component analysis.,"Independent component analysis (ICA) of electroencephalographic (EEG) and magnetoencephalographic (MEG) data is usually performed over the temporal dimension: each channel is one row of the data matrix, and a linear transformation maximizing the independence of component time courses is sought. In functional magnetic resonance imaging (fMRI), by contrast, most studies use spatial ICA: each time point constitutes a row of the data matrix, and independence of the spatial patterns is maximized. Here, we show the utility of spatial ICA in characterizing oscillatory neuromagnetic signals. We project the sensor data into cortical space using a standard minimum-norm estimate and apply a sparsifying transform to focus on oscillatory signals. The resulting method, spatial Fourier-ICA, provides a concise summary of the spatiotemporal and spectral content of spontaneous neuromagnetic oscillations in cortical source space over time scales of minutes. Spatial Fourier-ICA applied to resting-state and naturalistic stimulation MEG data from nine healthy subjects revealed consistent components covering the early visual, somatosensory and motor cortices with spectral peaks at ∼10 and ∼20 Hz. The proposed method seems valuable for inferring functional connectivity, stimulus-related modulation of rhythmic activity, and their commonalities across subjects from nonaveraged MEG data.",2012,"The proposed method seems valuable for inferring functional connectivity, stimulus-related modulation of rhythmic activity, and their commonalities across subjects from nonaveraged MEG data.",['nine healthy subjects'],"['spatial ICA', 'functional magnetic resonance imaging (fMRI']",['electroencephalographic (EEG) and magnetoencephalographic (MEG) data'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",[],9.0,0.0378079,"The proposed method seems valuable for inferring functional connectivity, stimulus-related modulation of rhythmic activity, and their commonalities across subjects from nonaveraged MEG data.","[{'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Ramkumar', 'Affiliation': 'Low Temperature Laboratory, Brain Research Unit, Aalto University School of Science, Aalto, Finland. pavan@neuro.hut.fi'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Parkkonen', 'Affiliation': ''}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Hari', 'Affiliation': ''}, {'ForeName': 'Aapo', 'Initials': 'A', 'LastName': 'Hyvärinen', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21303'] 1588,21618661,Overnight deprivation from smoking disrupts amygdala responses to fear.,"Cigarette smoking, a major, yet avoidable, cause of disability and premature death, is the most prevalent form of nicotine addiction. An emerging theme in the neurobiology of nicotine addiction is the integrity of the amygdala. Using functional MRI, amygdala responses during a face perception task were compared between 28 chronic smokers [14 females, 14 males; age, 26.3 (2.8) years; age at onset of smoking, 15.8 (2.6) years; years smoked, 9.1 (2.1); cigarettes per day, 17.1 (3.7); Fagerström test for nicotine dependence score, 4.1 (1.9); exhaled carbon-monoxide level, 17.8 (9.5) ppm] and 28 age- and education-matched nonsmokers [14 females, 14 males; age, 26.9 (2.4) years]. Subjects underwent imaging on two separate occasions 1 week apart: smoking satiety versus overnight smoking deprivation, in a randomized counterbalanced order. Our results show no difference in amygdala responses to faces between nonsmokers and satiated smokers. However, overnight deprivation from smoking was associated with a significantly lowered amygdala response to fear, an effect that was probabilistically mapped to the basolateral amygdala. We suggest that aberrant amygdala reactivity in overnight-deprived smokers may reflect a pre-existing vulnerability to smoking and/or increase the risk of smoking relapse after a cessation attempt.",2012,"However, overnight deprivation from smoking was associated with a significantly lowered amygdala response to fear, an effect that was probabilistically mapped to the basolateral amygdala.","['28 chronic smokers [14 females, 14 males; age, 26.3 (2.8) years; age at onset of smoking, 15.8 (2.6) years; years smoked, 9.1 (2.1); cigarettes per day, 17.1 (3.7); Fagerström test for nicotine dependence score, 4.1 (1.9); exhaled carbon-monoxide level, 17.8 (9.5) ppm] and 28 age- and education-matched nonsmokers [14 females, 14 males; age, 26.9 (2.4) years']",['smoking satiety versus overnight smoking deprivation'],"['amygdala responses', 'risk of smoking relapse']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517668', 'cui_str': 'Twenty-six point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",28.0,0.0123445,"However, overnight deprivation from smoking was associated with a significantly lowered amygdala response to fear, an effect that was probabilistically mapped to the basolateral amygdala.","[{'ForeName': 'Oezguer A', 'Initials': 'OA', 'LastName': 'Onur', 'Affiliation': 'Department of Psychiatry, University of Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Patin', 'Affiliation': ''}, {'ForeName': 'Yoan', 'Initials': 'Y', 'LastName': 'Mihov', 'Affiliation': ''}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Buecher', 'Affiliation': ''}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': ''}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Schlaepfer', 'Affiliation': ''}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Walter', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21293'] 1589,21630376,A brain-potential study of preparation for and execution of a task-switch with stimuli that afford only the relevant task.,"Behavioural and neurophysiological studies of task-switching have tended to employ 'bivalent' stimuli (which afford responses in two tasks). Using brain potential recordings, we investigated task-switching with 'univalent' stimuli affording responses in only one of the tasks, and compared the outcomes to those recently obtained with bivalent stimuli (Lavric et al. [2008]: Eur J Neurosci 1-14), in order to examine two phenomena. First, when only univalent stimuli are presented, the processing of task cues becomes optional. Our results showed that in these circumstances linguistic (but not pictorial) cues were still effective in eliciting at least some degree of preparation for a task-switch, as evidenced by the reduction in the error cost of switching at the longer preparation interval and by a posterior switch-induced ERP positivity at about 450-800 ms in the cue-stimulus interval. Second, single affordance stimuli not only reduced behavioural switch costs relative to bivalent stimuli; they also produced a smaller post-stimulus switch-induced negativity, consistent with the latter being a marker of conflict between task-sets. However, using stimuli not associated with responses in the alternative task did not completely eliminate the negativity. We speculate that the residue reflects other sources of conflict: attention to the irrelevant perceptual dimension and/or persistence of task goals.",2012,"Second, single affordance stimuli not only reduced behavioural switch costs relative to bivalent stimuli; they also produced a smaller post-stimulus switch-induced negativity, consistent with the latter being a marker of conflict between task-sets.",['2008'],[],"['behavioural switch costs relative to bivalent stimuli', 'ERP positivity']",[],[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}]",,0.0179778,"Second, single affordance stimuli not only reduced behavioural switch costs relative to bivalent stimuli; they also produced a smaller post-stimulus switch-induced negativity, consistent with the latter being a marker of conflict between task-sets.","[{'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Elchlepp', 'Affiliation': 'School of Psychology, University of Exeter, United Kingdom. h.elchlepp@ex.ac.uk'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': ''}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'Mizon', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Monsell', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21277'] 1590,21739525,Neural mechanisms underlying the grouping effect in short-term memory.,"Dividing auditory sequence into groups, or imposing rhythmic, tonal, or spatial structure during presentation, improves recall performance. Several competing computational models have been proposed to account for these effects, but little is known about the neural correlates of grouping and hence the representations that encode grouped sequences. The present study used functional magnetic resonance imaging (fMRI) to compare the auditory encoding of grouped and ungrouped lists of sub-span (six letters) and supra-span (nine letters) length in an immediate serial recall (ISR) task. Analysis of activation revealed an extensive premotor and prefrontal network, which was significantly less active when short-term memory (STM) span was exceeded during encoding. Only primary auditory cortex showed an increase in activation when memory span was exceeded. Comparison of activation for grouped and ungrouped lists showed that during the subspan phase bilateral planum temporale showed less activation for grouped stimuli, while during the supra-span phase supramarginal and inferior parietal areas were more active for grouped lists. The magnitude of both temporal and parietal activations predicted enhanced recall of grouped lists. Thus neural signatures of grouping seem to reflect more structured processing in parietal areas instead of reliance on perceptual-auditory processing in temporal regions.",2012,Only primary auditory cortex showed an increase in activation when memory span was exceeded.,[],"['auditory encoding of grouped and ungrouped lists of sub-span (six letters) and supra-span (nine letters) length in an immediate serial recall (ISR) task', 'functional magnetic resonance imaging (fMRI']","['activation when memory span', 'recall performance']",[],"[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.027556,Only primary auditory cortex showed an increase in activation when memory span was exceeded.,"[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Kalm', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, Cambridge, UK. kristjan.kalm@mrc-cbu.cam.ac.uk'}, {'ForeName': 'Matthew H', 'Initials': 'MH', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Norris', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21308'] 1591,21674691,Selective BOLD responses to individual finger movement measured with fMRI at 3T.,"Although the gross somatotopic organization of the posterior bank of the precentral gyrus is well established, a fine scale organization of the representations of the digits of the hand has not been fully characterized. Previous neuroimaging studies have failed to find clear evidence for a specificity of digit representations in motor cortex, but rather report a distributed network of control. Reported here are the results of two experiments; in Experiment 1 a sequential finger tapping task produced strong blood oxygen level dependent (BOLD) responses in the contralateral precentral gyrus, but there was a lack of specificity for distinguishing individual representations. A randomly ordered task did accomplish this goal. In the second experiment, a randomly ordered finger-tapping task was used and the findings demonstrated BOLD responses in clusters of voxels specific to movement of a single digit. The region of interest defined for each digit comprised several noncontiguous clusters. A ""selectivity index"" was developed to quantify the magnitude of the BOLD response to the movement of a specific digit, relative to BOLD response associated with movement of other digits. Strong evidence of BOLD selectivity (albeit not exclusivity) was found in the hemisphere contralateral to the cued digit; however, there was no evidence for an orderly spatial topography. These findings demonstrate that a selectivity of activation is quantifiable, supports a theory of noncontiguous distribution of control, and provides a method for comparing between healthy and impaired populations and investigating changes following training or intervention.",2012,"Strong evidence of BOLD selectivity (albeit not exclusivity) was found in the hemisphere contralateral to the cued digit; however, there was no evidence for an orderly spatial topography.",[],[],"['blood oxygen level dependent (BOLD) responses', 'BOLD selectivity']",[],[],"[{'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",,0.0230202,"Strong evidence of BOLD selectivity (albeit not exclusivity) was found in the hemisphere contralateral to the cued digit; however, there was no evidence for an orderly spatial topography.","[{'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Olman', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Pickett', 'Affiliation': ''}, {'ForeName': 'Michael-Paul', 'Initials': 'MP', 'LastName': 'Schallmo', 'Affiliation': ''}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21310'] 1592,21618664,fMRI investigation of speed-accuracy strategy switching.,"Switching between rapid and accurate responses is an important aspect of decision-making. However, the brain mechanisms important to smoothly change the speed-accuracy strategy remain mostly unclear. This issue was addressed here by using functional magnetic resonance imaging (fMRI). On each trial, right-handed healthy participants had to stress speed or accuracy in performing a color discrimination task on a target stimulus according to the instructions given by an initial cue. Participants were capable of trading speed for accuracy and vice versa. Analyses of cue-related fMRI activations revealed a significant recruitment of left middle frontal gyrus and right cerebellum when switching from speed to accuracy. The left superior parietal lobule was activated in the same switching condition but only after the target onset. The anterior cingulate cortex was more recruited, also after target presentation, when speed had to be maintained from one trial to the next. These results are interpreted within a theoretical framework that attributes a role in criterion-setting to the left lateral prefrontal cortex, perceptual evidence accumulation to the superior parietal lobule, and action energization to the anterior cingulate cortex, extending previous findings to the domain of speed-accuracy tradeoff regulations.",2012,Analyses of cue-related fMRI activations revealed a significant recruitment of left middle frontal gyrus and right cerebellum when switching from speed to accuracy.,[],['functional magnetic resonance imaging (fMRI'],['left middle frontal gyrus and right cerebellum'],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}]",,0.0157433,Analyses of cue-related fMRI activations revealed a significant recruitment of left middle frontal gyrus and right cerebellum when switching from speed to accuracy.,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Vallesi', 'Affiliation': 'Rotman Research Institute at Baycrest, Toronto, Canada. vallesi@sissa.it'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'McIntosh', 'Affiliation': ''}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Crescentini', 'Affiliation': ''}, {'ForeName': 'Donald T', 'Initials': 'DT', 'LastName': 'Stuss', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21312'] 1593,32493217,Cardiotoxicity evaluation using magnetic resonance imaging in breast Cancer patients (CareBest): study protocol for a prospective trial.,"BACKGROUND Cardiovascular disease is second only to cancer recurrence as a determinant of lifespan in cancer survivors, and cancer therapy-related cardiac dysfunction is a clinically important risk factor. We aim to investigate the use of cardiac magnetic resonance imaging (MRI) to evaluate early tissue changes and perform functional assessment of chemo- and radiation-induced cardiotoxicity and to identify MRI prognostic indicators of cardiotoxicity in breast cancer patients. METHODS A 3-min cardiac imaging protocol will be added to the breast MRI examination to diagnose cardiotoxicity in breast cancer patients. Standardized MRI-based evaluation of breast cancer and the left ventricular myocardium will be performed at baseline and at 3, 6, and 12 months and 2 years or more after cancer treatment. We will analyze both ventricular volume and ejection fraction (EF), strain of left ventricle (LV), native T1, extracellular volume fraction (ECV), and T2 values acquired in the mid LV. DISCUSSION The primary result of this study will be the comparison of the prognostic value of MRI parameters (native T1, ECV, both ventricular systolic function and LV strain) for cardiotoxicity. The endpoint is defined as the occurrence of a major adverse cardiac event (MACE). The secondary outcome will be an assessment of the temporal relationships between contractile dysfunction and microstructural injury over 4 years using MRI. This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment. TRIAL REGISTRATION The protocol was registered at clinicaltrials.gov (Clinical trial no. NCT03301389) on October 4, 2017.",2020,"This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment. ","['breast cancer patients', 'breast Cancer patients (CareBest']","['cardiac magnetic resonance imaging (MRI', 'chemo- and radiation-induced cardiotoxicity', 'magnetic resonance imaging']","['ventricular volume and ejection fraction (EF), strain of left ventricle (LV), native T1, extracellular volume fraction (ECV), and T2 values acquired in the mid LV', 'occurrence of a major adverse cardiac event (MACE', 'prognostic value of MRI parameters (native T1, ECV, both ventricular systolic function and LV strain) for cardiotoxicity', 'Cardiotoxicity evaluation', 'contractile dysfunction and microstructural injury over 4\u2009years using MRI']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0698136,"This study will assess the usefulness of quantitative MRI to diagnose cardiotoxicity and will clarify the temporal relationships between contractile dysfunction and microstructural injury of the LV myocardium using MRI during breast cancer treatment. ","[{'ForeName': 'Yoo Jin', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyunghwa', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Pan Ki', 'Initials': 'PK', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Su An', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'An', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Hye-Jeong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Hur', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. MINES@yuhs.ac.'}, {'ForeName': 'Byoung Wook', 'Initials': 'BW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. bchoi305@gmail.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01497-y'] 1594,21484950,Pramipexole modulates the neural network of reward anticipation.,"Pramipexole is widely prescribed to treat Parkinson's disease. It has been found to cause impulse control disorders such as pathological gambling. To examine how pramipexole modulates the network of reward anticipation, we carried out a pharmacological functional magnetic resonance imaging study with a double-blind, within-subject design. During the anticipation of monetary rewards, pramipexole increased the activity of the nucleus accumbens (NAcc), enhanced the interaction between the NAcc and the anterior insula, but weakened the interaction between the NAcc and the prefrontal cortex. These results suggest that pramipexole may exaggerate incentive and affective responses to possible rewards, but reduce the top-down control of impulses, leading to an increase in impulsive behaviors. This imbalance between the prefrontal-striatum connectivity and the insula-striatum connectivity may represent the neural mechanism of pathological gambling caused by pramipexole.",2011,"During the anticipation of monetary rewards, pramipexole increased the activity of the nucleus accumbens (NAcc), enhanced the interaction between the NAcc and the anterior insula, but weakened the interaction between the NAcc and the prefrontal cortex.",[],"['Pramipexole', 'pramipexole']","['impulsive behaviors', 'activity of the nucleus accumbens (NAcc', 'neural network of reward anticipation']",[],"[{'cui': 'C0074710', 'cui_str': 'Pramipexole'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.0419904,"During the anticipation of monetary rewards, pramipexole increased the activity of the nucleus accumbens (NAcc), enhanced the interaction between the NAcc and the anterior insula, but weakened the interaction between the NAcc and the prefrontal cortex.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Psychology, Peking University, Beijing, China.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': ''}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Camara', 'Affiliation': ''}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Münte', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21067'] 1595,21538705,Age-related changes in visually evoked electrical brain activity.,"Whereas much is known about the degenerative effects of aging on cortical tissue, less is known about how aging affects visually evoked electrical activity, and at what latencies. We compared visual processing in elderly and young controls using a visual masking paradigm, which is particularly sensitive to detect temporal processing deficits, while recording EEG. The results show that, on average, elderly have weaker visual evoked potentials than controls, and that elderly show a distinct scalp potential topography (microstate) at around 150 ms after stimulus onset. This microstate occurred irrespective of the visual stimulus presented. Electrical source imaging showed that the changes in the scalp potential resulted from decreased activity in lateral occipital cortex and increases in fronto-parietal areas. We saw, however, no evidence that increased fronto-parietal activity enhanced performance on the discrimination task, and no evidence that it compensated for decreased posterior activity. Our results show qualitatively different patterns of visual evoked potentials (VEPs) in the elderly, and demonstrate that increased fronto-parietal activity arises during visual processing in the elderly already between 150 and 200 ms after stimulus onset. The microstate associated with these changes is a potential diagnostic tool to detect age-related cortical changes.",2012,"We saw, however, no evidence that increased fronto-parietal activity enhanced performance on the discrimination task, and no evidence that it compensated for decreased posterior activity.",['elderly and young controls'],[],"['posterior activity', 'visual evoked potentials (VEPs', 'visual processing', 'activity in lateral occipital cortex']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3811911', 'cui_str': 'Cuneus'}]",,0.0175317,"We saw, however, no evidence that increased fronto-parietal activity enhanced performance on the discrimination task, and no evidence that it compensated for decreased posterior activity.","[{'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Plomp', 'Affiliation': 'Laboratory of Psychophysics, Brain Mind Institute, School of Life Sciences, Ecole Polytechnique Fédéral de Lausanne, Lausanne, Switzerland. gijs.plomp@unige.ch'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Kunchulia', 'Affiliation': ''}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Herzog', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21273'] 1596,32493213,Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial.,"BACKGROUND The application of bedside ultrasound to evaluate gastric content and volume can assist in determining aspiration risk. Applying positive pressure ventilation via supraglottic airway devices (SAD) can result in a degree of gastric insufflation. This study assessed and compared the antral cross-sectional area (CSA) in patients undergoing laparoscopic gynecological surgery when managed with different SAD. METHODS One hundred American Society of Anesthesiologists I or II female patients were assessed for inclusion in this study and divided into three groups of different ventilation devices. Patients were randomly allocated into three groups to receive LMA-Supreme (Group S), I-gel (Group I) or tracheal tube (Group T). The primary outcome was the antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting. RESULTS The antral CSA was not significantly different among three groups before induction (P = 0.451), after induction (P = 0.456) and at the end of surgery (P = 0.195). The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01). Sore throat was detected in none in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and fifteen patients (50%) in the tracheal tube group. Hoareness was detected in one (3.3%) in the I-gel group compare to two patients (6.7%) in the LMA-Supreme group and eleven patients (36.7%) in the tracheal tube group. CONCLUSIONS The SADs do not cause obvious gastric insufflation. Thus, LMA-Supreme and I-gel can be widely used as alternative to endotracheal intubation for the short laparoscopic gynecological surgery. TRIAL REGISTRATION This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1800018212, data of registration, September 2018).",2020,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"['One hundred American Society of Anesthesiologists', 'laparoscopic gynecological surgery by ultrasound', 'I or II female patients', 'patients undergoing laparoscopic gynecological surgery when managed with different SAD']","['LMA-Supreme (Group S), I-gel (Group I) or tracheal tube', 'positive pressure ventilation via supraglottic airway devices (SAD', 'LMA-supreme and I-gel versus tracheal intubation']","['antral cross-sectional area and secondary outcomes included haemodynamic parameters and postoperative morbidity such as sore throat, hoarseness, dry throat, nausea and vomiting', 'haemodynamic variables', 'Hoareness', 'Sore throat', 'antral CSA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0235234', 'cui_str': 'Pharyngeal dryness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",100.0,0.131033,The haemodynamic variables were significantly higher in the tracheal tube group than in the LMA-Supreme and I-gel groups after insertion (P < 0.0001) and after removal (P < 0.01).,"[{'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China.""}, {'ForeName': 'Gordon Tin Chun', 'Initials': 'GTC', 'LastName': 'Wong', 'Affiliation': ""Department of Anesthesiology, The University of Hong Kong, Hong Kong SAR, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Hefei, 230022, Anhui Province, People's Republic of China. luyao-mz@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01057-z'] 1597,19894215,Drug effect on EEG connectivity assessed by linear and nonlinear couplings.,"Quantitative analysis of human electroencephalogram (EEG) is a valuable method for evaluating psychopharmacological agents. Although the effects of different drug classes on EEG spectra are already known, interactions between brain locations remain unclear. In this work, cross mutual information function and appropriate surrogate data were applied to assess linear and nonlinear couplings between EEG signals. The main goal was to evaluate the pharmacological effects of alprazolam on brain connectivity during wakefulness in healthy volunteers using a cross-over, placebo-controlled design. Eighty-five pairs of EEG leads were selected for the analysis, and connectivity was evaluated inside anterior, central, and posterior zones of the scalp. Connectivity between these zones and interhemispheric connectivity were also measured. Results showed that alprazolam induced significant changes in EEG connectivity in terms of information transfer in comparison with placebo. Trends were opposite depending on the statistical characteristics: decreases in linear connectivity and increases in nonlinear couplings. These effects were generally spread over the entire scalp. Linear changes were negatively correlated, and nonlinear changes were positively correlated with drug plasma concentrations; the latter showed higher correlation coefficients. The use of both linear and nonlinear approaches revealed the importance of assessing changes in EEG connectivity as this can provide interesting information about psychopharmacological effects.",2010,"Linear changes were negatively correlated, and nonlinear changes were positively correlated with drug plasma concentrations; the latter showed higher correlation coefficients.",['healthy volunteers'],"['alprazolam', 'human electroencephalogram (EEG', 'placebo']","['brain connectivity', 'EEG connectivity', 'linear connectivity and increases in nonlinear couplings']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",85.0,0.0281139,"Linear changes were negatively correlated, and nonlinear changes were positively correlated with drug plasma concentrations; the latter showed higher correlation coefficients.","[{'ForeName': 'Joan F', 'Initials': 'JF', 'LastName': 'Alonso', 'Affiliation': 'Biomedical Engineering Research Center, Department of Automatic Control, Universitat Politècnica de Catalunya, Barcelona, Spain. joan.francesc.alonso@upc.edu'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Mañanas', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hoyer', 'Affiliation': ''}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Riba', 'Affiliation': ''}, {'ForeName': 'Manel J', 'Initials': 'MJ', 'LastName': 'Barbanoj', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20881'] 1598,21391283,"Effects of morphine and alcohol on functional brain connectivity during ""resting state"": a placebo-controlled crossover study in healthy young men.","A major challenge in central nervous system (CNS) drug research is to develop a generally applicable methodology for repeated measurements of drug effects on the entire CNS, without task-related interactions and a priori models. For this reason, data-driven resting-state fMRI methods are promising for pharmacological research. This study aimed to investigate whether different psychoactive substances cause drug-specific effects in functional brain connectivity during resting-state. In this double blind placebo-controlled (double dummy) crossover study, seven resting-state fMRI scans were obtained in 12 healthy young men in three different drug sessions (placebo, morphine and alcohol; randomized). Drugs were administered intravenously based on validated pharmacokinetic protocols to minimize the inter- and intra-subject variance in plasma drug concentrations. Dual-regression was used to estimate whole-brain resting-state connectivity in relation to eight well-characterized resting-state networks, for each data set. A mixed effects analysis of drug by time interactions revealed dissociable changes in both pharmacodynamics and functional connectivity resulting from alcohol and morphine. Post hoc analysis of regions of interest revealed adaptive network interactions in relation to pharmacokinetic and pharmacodynamic curves. Our results illustrate the applicability of resting-state functional brain connectivity in CNS drug research.",2012,A mixed effects analysis of drug by time interactions revealed dissociable changes in both pharmacodynamics and functional connectivity resulting from alcohol and morphine.,"['healthy young men', '12 healthy young men in three different drug sessions ']","['morphine', 'placebo', 'morphine and alcohol', 'placebo, morphine and alcohol']",['functional brain connectivity'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",12.0,0.0839765,A mixed effects analysis of drug by time interactions revealed dissociable changes in both pharmacodynamics and functional connectivity resulting from alcohol and morphine.,"[{'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Khalili-Mahani', 'Affiliation': 'Leiden Institute for Brain and Cognition, Leiden University, The Netherlands. n.mahani@lumc.nl'}, {'ForeName': 'Remco M W', 'Initials': 'RM', 'LastName': 'Zoethout', 'Affiliation': ''}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Beckmann', 'Affiliation': ''}, {'ForeName': 'Evelinda', 'Initials': 'E', 'LastName': 'Baerends', 'Affiliation': ''}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': ''}, {'ForeName': 'Roelof P', 'Initials': 'RP', 'LastName': 'Soeter', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'van Buchem', 'Affiliation': ''}, {'ForeName': 'Joop M A', 'Initials': 'JM', 'LastName': 'van Gerven', 'Affiliation': ''}, {'ForeName': 'Serge A R B', 'Initials': 'SA', 'LastName': 'Rombouts', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21265'] 1599,31537689,KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study.,"In recent years, the outcome of mantle cell lymphoma (MCL) has improved, especially in younger patients, receiving cytarabine-containing chemoimmunotherapy and autologous stem cell transplantation. Nevertheless, a proportion of MCL patients still experience early failure. To identify biomarkers anticipating failure of intensive chemotherapy in MCL, we performed target resequencing and DNA profiling of purified tumor samples collected from patients enrolled in the prospective FIL-MCL0208 phase 3 trial (high-dose chemoimmunotherapy followed by autologous transplantation and randomized lenalidomide maintenance). Mutations of KMT2D and disruption of TP53 by deletion or mutation associated with an increased risk of progression and death, both in univariate and multivariate analysis. By adding KMT2D mutations and TP53 disruption to the MIPI-c backbone, we derived a new prognostic index, the ""MIPI-genetic"" (""MIPI- g""). The ""MIPI-g"" improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-year progression free survival and overall survival of 72.0% and 94.5%); ii) inter-mediate-risk patients (4-year progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-year progression free survival and overall survival of 11.5% and 44.9%). Our results: i) confirm that TP53 disruption identifies a high-risk population characterized by poor sensitivity to conventional or intensified chemotherapy; ii) provide the pivotal evidence that patients harboring KMT2D mutations share the same poor outcome as patients harboring TP53 disruption; and iii) allow to develop a tool for the identification of high-risk MCL patients for whom novel therapeutic strategies need to be investigated. ( Trial registered at clinicaltrials.gov identifier: NCT02354313 ).",2020,"The MIPI-g improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-years progression free survival and overall survival of 72.0% and 94.5%); ii) intermediate-risk patients (4-years progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-years progression free survival and overall survival of 11.5% and 44.9%).","['mantle cell lymphoma', 'patients enrolled in the prospective FIL-MCL0208 phase III trial (high-dose chemoimmunotherapy followed by autologous transplantation and randomized lenalidomide maintenance']",['cytarabine-containing chemoimmunotherapy and autologous stem cell transplantation'],"['progression free survival and overall survival', 'risk of progression and death', 'model discrimination ability']","[{'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.034178,"The MIPI-g improved the model discrimination ability compared to the MIPI-c alone, defining three risk groups: i) low-risk patients (4-years progression free survival and overall survival of 72.0% and 94.5%); ii) intermediate-risk patients (4-years progression free survival and overall survival of 42.2% and 65.8%) and iii) high-risk patients (4-years progression free survival and overall survival of 11.5% and 44.9%).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy simone.ferrero@unito.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Rossi', 'Affiliation': 'Hematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rinaldi', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Bruscaggin', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Spina', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Eskelund', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Evangelista', 'Affiliation': 'Clinical Epidemiology, Città della Salute e della Scienza and CPO Piemonte, Torino, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Moia', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Kwee', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dahl', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Di Rocco', 'Affiliation': 'Department of Cellular Biotechnologies and Hematology, Policlinico Umberto I, ""Sapienza"" University of Rome, Roma, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Stefoni', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Fary', 'Initials': 'F', 'LastName': 'Diop', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Favini', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ghione', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy.'}, {'ForeName': 'Abdurraouf Mokhtar', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Schipani', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Kolstad', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Barbero', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences - Hematology Division, Università di Torino, Torino, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Novero', 'Affiliation': 'First Unit of Pathology, AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Paulli', 'Affiliation': 'Unit of Anatomic Pathology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and Università degli Studi di Pavia, Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zamò', 'Affiliation': 'Department of Oncology, Università di Torino, Torino, Italy.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Jerkeman', 'Affiliation': 'Department of Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Maria Gomes', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Department of Hematology, Instituto Português de Oncologia de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, Italy.'}, {'ForeName': 'Annalia', 'Initials': 'A', 'LastName': 'Molinari', 'Affiliation': 'Hematology, Ospedale degli Infermi, Rimini, Italy.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Ferreri', 'Affiliation': 'Lymphoma Unit, Department of Onco-Haematology, IRCCS San Raffaele Scientific Institute, Milano, Italy.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Piccin', 'Affiliation': 'Department of Hematology, Ospedale Generale, Bolzano, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cortelazzo', 'Affiliation': 'Oncology Unit, Humanitas/Gavazzeni Clinic, Bergamo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bertoni', 'Affiliation': ""Universita' della Svizzera italiana, Institute of Oncology Research, Bellinzona, Switzerland.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ladetto', 'Affiliation': 'SC Ematologia, Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gaidano', 'Affiliation': 'Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.'}]",Haematologica,['10.3324/haematol.2018.214056'] 1600,31539025,Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT).,"OBJECTIVES To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG). METHODS In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury. RESULTS In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed. CONCLUSIONS The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG. CLINICAL TRIAL REGISTRATION NUMBER ISRCTN02159606.",2020,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","['diabetic patients', '169 patients were randomized (84 VRT, 85 usual care; mean age 64\u2009years; 88% male', 'diabetic patients undergoing coronary artery bypass grafting (CABG', 'DIabetic patients undergoing coronary artery bypass grafting surgery', 'diabetic patients undergoing CABG']","['preoperative VRT', 'Preoperative VolumE Replacement therapy', ""preoperative VRT (1\u2009ml/kg/h of Hartmann's solution for 12\u2009h) or usual care"", 'preoperative volume replacement therapy (VRT']","['Postoperative acute kidney injury', 'Time to fitness for discharge', 'time to fitness for discharge', 'acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury', 'renal function, health outcome and time to fitness for discharge', 'secondary health outcomes', 'microalbumin/creatinine ratio [geometric mean ratio (GMR', 'C-reactive protein', 'QoL', 'Estimated glomerular filtration rate']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3811844'}]",169.0,0.370451,"Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR)","[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Sarkar', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Rosie A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Narayan', 'Affiliation': 'Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hillier', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Ascione', 'Affiliation': 'Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivz226'] 1601,31514107,Can radiomics help to predict skeletal muscle response to chemotherapy in stage IV non-small cell lung cancer?,"BACKGROUND Muscle depletion negatively impacts treatment efficacy and survival rates in cancer. Prevention and timely treatment of muscle loss require prediction of patients at risk. We aimed to investigate the potential of skeletal muscle radiomic features to predict future muscle loss. METHODS A total of 116 patients with stage IV non-small cell lung cancer included in a randomised controlled trial (NCT01171170) studying the effect of nitroglycerin added to paclitaxel-carboplatin-bevacizumab were enrolled. In this post hoc analysis, muscle cross-sectional area and radiomic features were extracted from computed tomography images obtained before initiation of chemotherapy and shortly after administration of the second cycle. For internal cross-validation, the cohort was randomly split in a training set and validation set 100 times. We used least absolute shrinkage and selection operator method to select features that were most significantly associated with muscle loss and an area under the curve (AUC) for model performance. RESULTS Sixty-nine patients (59%) exhibited loss of skeletal muscle. One hundred ninety-three features were used to construct a prediction model for muscle loss. The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62). Differences in intensity and texture radiomic features over time were seen between patients with and without muscle loss. CONCLUSIONS The present study shows that skeletal muscle radiomics did not predict future muscle loss during chemotherapy in non-small cell lung cancer. Differences in radiomic features over time might reflect myosteatosis. Future imaging analysis combined with muscle tissue analysis in patients and in experimental models is needed to unravel the biological processes linked to the radiomic features.",2019,"The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62).","['patients at risk', '116 patients with stage IV non-small cell lung cancer', 'cancer', 'One hundred ninety-three features']",['nitroglycerin added to paclitaxel-carboplatin-bevacizumab'],"['muscle loss and an area under the curve (AUC', 'average AUC', 'loss of skeletal muscle', 'intensity and texture radiomic features']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}]",193.0,0.130463,"The average AUC was 0.49 (95% confidence interval [CI]: 0.36, 0.62).","[{'ForeName': 'E E C', 'Initials': 'EEC', 'LastName': 'de Jong', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'K J C', 'Initials': 'KJC', 'LastName': 'Sanders', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Deist', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'van Elmpt', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jochems', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'van Timmeren', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'R T H', 'Initials': 'RTH', 'LastName': 'Leijenaar', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'J H R J', 'Initials': 'JHRJ', 'LastName': 'Degens', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A M W J', 'Initials': 'AMWJ', 'LastName': 'Schols', 'Affiliation': 'Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'A-M C', 'Initials': 'AC', 'LastName': 'Dingemans', 'Affiliation': 'Department of Respiratory Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lambin', 'Affiliation': 'The D-Lab: Decision Support for Precision Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: philippe.lambin@maastrichtuniversity.nl.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.023'] 1602,32430334,Polygenic risk for skin autoimmunity impacts immune checkpoint blockade in bladder cancer.,"PD-1 and PD-L1 act to restrict T cell responses in cancer and contribute to self-tolerance. Consistent with this role, PD-1 checkpoint inhibitors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be autoimmune in origin. Analyses of dermatological irAEs have identified an association with improved overall survival (OS) following anti-PD-(L)1 therapy, but the factors that contribute to this relationship are poorly understood. We collected germline whole-genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. We found that high vitiligo, high psoriasis, and low atopic dermatitis polygenic risk scores (PRSs) were associated with longer OS under anti-PD-L1 monotherapy as compared to chemotherapy, reflecting the Th17 polarization of these diseases. PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures. Shared genetic factors impact risk for dermatological autoimmunity and anti-PD-L1 monotherapy in bladder cancer.",2020,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.",['bladder cancer'],['atezolizumab (anti-PD-L1) monotherapy'],"['overall survival (OS', 'low atopic dermatitis polygenic risk scores (PRSs']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0526833,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.","[{'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Di Nucci', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kwan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hammer', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rouilly', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Fontes', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ley Acosta', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Chen-Harris', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhangale', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Mellman', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hunkapiller', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Chandler', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1922867117'] 1603,20522698,Effectiveness of an e-learning course in evidence-based medicine for foundation (internship) training.,"AIM To evaluate the educational effectiveness of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content. METHODS We conducted a cluster randomized controlled trial to compare a clinically integrated e-learning EBM course (intervention) to a lecture-based course (control) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midlands region. Knowledge gain among participants was measured with a validated instrument using multiple choice questions. Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations (GEE) model. RESULTS There were seven clusters involving teaching of 237 trainees (122 in the intervention and 115 in the control group). The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group. After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups. The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points (95% CI -1.2-1.4). CONCLUSION An e-learning course in EBM was as effective in improving knowledge as a standard lecture-based course. The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows standardization of teaching materials and is a potential cost-effective alternative to standard lecture-based teaching.",2010,"After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups.","['postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midlands region', 'postgraduate medical trainees']","['clinically integrated e-learning EBM course (intervention) to a lecture-based course (control', 'clinically integrated e-learning course for teaching basic evidence-based medicine (EBM']","['knowledge of EBM', 'Knowledge gain', 'total number of postgraduate trainees', 'educational effectiveness']","[{'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376537', 'cui_str': 'Evidence-Based Medicine'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",237.0,0.0588821,"After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hadley', 'Affiliation': 'Staffordshire University, Faculty of Health Staffordshire ST18 0AD, UK.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Kulier', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ''}, {'ForeName': 'Sjors F P J', 'Initials': 'SF', 'LastName': 'Coppus', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Weinbrenner', 'Affiliation': ''}, {'ForeName': 'Berrit', 'Initials': 'B', 'LastName': 'Meyerrose', 'Affiliation': ''}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Decsi', 'Affiliation': ''}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Horvath', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': ''}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Emparanza', 'Affiliation': ''}, {'ForeName': 'Theodoros N', 'Initials': 'TN', 'LastName': 'Arvanitis', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Burls', 'Affiliation': ''}, {'ForeName': 'Juan B', 'Initials': 'JB', 'LastName': 'Cabello', 'Affiliation': ''}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kaczor', 'Affiliation': ''}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Zanrei', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pierer', 'Affiliation': ''}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Kunz', 'Affiliation': ''}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Wilkie', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wall', 'Affiliation': ''}, {'ForeName': 'Ben Wj', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': ''}, {'ForeName': 'Khalid S', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,['10.1258/jrsm.2010.100036'] 1604,32493211,"Dural sac cross-sectional area is a highly effective parameter for spinal anesthesia in geriatric patients undergoing transurethral resection of the prostate: a prospective, double blinded, randomized study.","BACKGROUND Spinal anesthesia is optimal choice for transurethral resection of the prostate (TURP), but the sensory block should not cross the T10 level. With advancing age, the sensory blockade level increases after spinal injection in some patients with spinal canal stenosis. We optimize the dose of spinal anesthesia according to the decreased ratio of the dural sac cross-sectional area (DSCSA), the purpose of this study is to hypothesis that if DSCSA is an effective parameter to modify the dosage of spinal anesthetics to achieve a T10 blockade in geriatric patients undergoing TURP. METHODS Sixty geriatric patients schedule for TURP surgery were enrolled in this study. All subjects were randomized divided into two groups, the ultrasound (group U) and the control (group C) groups, patient receive either a dose of 2 ml of 0.5% isobaric bupivacaine in group C, or a modified dose of 0.5% isobaric bupivacaine in group U. We measured the sagittal anteroposterior diameter (D) of the dural sac at the L3-4 level with ultrasound, and calculated the approximate DSCSA (A) according to the following formula: A = π(D/2) 2 , ( π = 3.14). The modified dosage of bupivacaine was adjusted according to the decreased ratio of the DSCSA. RESULTS The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9). The dosage of bupivacaine was significantly decreased in group U compared with group C (P < 0.001). The regression times of the two segments were delay in group U compared with group C (P < 0.001). The maximal decrease in MAP was significantly higher in the group C than in group U after spinal injection (P < 0.001), without any modifications HR in either group. Eight patients in group C and two patients in group U required ephedrine (P = 0.038). CONCLUSIONS The DSCSA is a highly effective parameter for spinal anesthesia in geriatric patients undergoing TURP, a modified dose of local anesthetic is a critical factor for controlling the sensory level. TRIAL REGISTRATION This study was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR1800015566).on 8, April, 2018.",2020,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","['Sixty geriatric patients schedule for TURP surgery were enrolled in this study', 'geriatric patients undergoing transurethral resection of the prostate', 'geriatric patients undergoing TURP', 'geriatric patients undergoing', 'patients with spinal canal stenosis']","['TURP', 'bupivacaine', 'DSCSA', 'modified dose of 0.5% isobaric bupivacaine', 'patient receive either a dose of 2\u2009ml of 0.5% isobaric bupivacaine', 'spinal anesthesia', 'ephedrine']","['sagittal anteroposterior diameter (D) of the dural sac', 'cephalad spread of the sensory blockade level', 'maximal decrease in MAP']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1861329', 'cui_str': 'Spinal canal stenosis'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",60.0,0.0363662,"The cephalad spread of the sensory blockade level was significantly lower (P < 0.001) in group U (T10, range T7-T12) compared with group C (T3, range T2-T9).","[{'ForeName': 'Wei Bing', 'Initials': 'WB', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China. w2bwang@sina.com.'}, {'ForeName': 'Ai Jiao', 'Initials': 'AJ', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Hong Ping', 'Initials': 'HP', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Jing Chun', 'Initials': 'JC', 'LastName': 'Dong', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Affiliated AnQing Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui province, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01059-x'] 1605,20336685,Dehydration affects brain structure and function in healthy adolescents.,"It was recently observed that dehydration causes shrinkage of brain tissue and an associated increase in ventricular volume. Negative effects of dehydration on cognitive performance have been shown in some but not all studies, and it has also been reported that an increased perceived effort may be required following dehydration. However, the effects of dehydration on brain function are unknown. We investigated this question using functional magnetic resonance imaging (fMRI) in 10 healthy adolescents (mean age = 16.8, five females). Each subject completed a thermal exercise protocol and nonthermal exercise control condition in a cross-over repeated measures design. Subjects lost more weight via perspiration in the thermal exercise versus the control condition (P < 0.0001), and lateral ventricle enlargement correlated with the reduction in body mass (r = 0.77, P = 0.01). Dehydration following the thermal exercise protocol led to a significantly stronger increase in fronto-parietal blood-oxygen-level-dependent (BOLD) response during an executive function task (Tower of London) than the control condition, whereas cerebral perfusion during rest was not affected. The increase in BOLD response after dehydration was not paralleled by a change in cognitive performance, suggesting an inefficient use of brain metabolic activity following dehydration. This pattern indicates that participants exerted a higher level of neuronal activity in order to achieve the same performance level. Given the limited availability of brain metabolic resources, these findings suggest that prolonged states of reduced water intake may adversely impact executive functions such as planning and visuo-spatial processing.",2011,"Subjects lost more weight via perspiration in the thermal exercise versus the control condition (P < 0.0001), and lateral ventricle enlargement correlated with the reduction in body mass (r = 0.77, P = 0.01).","['healthy adolescents', '10 healthy adolescents (mean age = 16.8, five females']","['thermal exercise protocol and nonthermal exercise control condition', 'functional magnetic resonance imaging (fMRI']","['ventricular volume', 'body mass', 'cognitive performance', 'fronto-parietal blood-oxygen-level-dependent (BOLD) response', 'cerebral perfusion', 'neuronal activity', 'weight via perspiration', 'BOLD response']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}]",10.0,0.0620207,"Subjects lost more weight via perspiration in the thermal exercise versus the control condition (P < 0.0001), and lateral ventricle enlargement correlated with the reduction in body mass (r = 0.77, P = 0.01).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Kempton', 'Affiliation': ""Centre for Neuroimaging Sciences, Institute of Psychiatry, King's College London, London, SE5 8AF, United Kingdom. matthew.kempton@iop.kcl.ac.uk""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': ''}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': ''}, {'ForeName': 'Steven C R', 'Initials': 'SC', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Calvert', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hampshire', 'Affiliation': ''}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ''}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': ""O'Gorman"", 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'McMorris', 'Affiliation': ''}, {'ForeName': 'Adrian M', 'Initials': 'AM', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'Marcus S', 'Initials': 'MS', 'LastName': 'Smith', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20999'] 1606,20162580,Thalamocortical sensorimotor circuit in multiple sclerosis: an integrated structural and electrophysiological assessment.,"Demyelination and axonal damage are pathologic hallmarks of multiple sclerosis (MS), leading to loss of neuronal synchronization, functional disconnection amongst brain relays, and clinical sequelae. To investigate these properties, the primary component of the sensorimotor network was analyzed in mildly disabled Relapsing-Remitting MS patients without sensory symptoms at the time of the investigation. By magnetoencephalography (MEG), the recruitment pattern within the primary sensory (S1) and motor (M1) areas was estimated through the morphology of the early components of somatosensory evoked magnetic fields (SEFs), after evaluating the S1 responsiveness to sensory inputs from the contralateral arm. In each hemisphere, network recruitment properties were correlated with ispilateral thalamus volume, estimated by morphometric techniques upon high-resolution 3D structural magnetic resonance images (MRI). S1 activation was preserved, whereas SEF morphology was strikingly distorted in MS patients, marking a disruption of primary somatosensory network patterning. An unbalance of S1-M1 dynamic recruitment was documented and correlated with the thalamic volume reduction in the left hemisphere. These findings support the model of MS as a disconnection syndrome, with major susceptibility to damage experienced by nodes belonging to more frequently recruited and highly specialized networks.",2010,An unbalance of S1-M1 dynamic recruitment was documented and correlated with the thalamic volume reduction in the left hemisphere.,"['multiple sclerosis', 'mildly disabled Relapsing-Remitting MS patients without sensory symptoms at the time of the investigation']","['Thalamocortical sensorimotor circuit', 'By magnetoencephalography (MEG']","['S1 activation', 'SEF morphology']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}]",,0.0213597,An unbalance of S1-M1 dynamic recruitment was documented and correlated with the thalamic volume reduction in the left hemisphere.,"[{'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': ""Dell'Acqua"", 'Affiliation': 'Neurologia Clinica, Universitá Campus Bio-Medico, Roma, Italy.'}, {'ForeName': 'Doriana', 'Initials': 'D', 'LastName': 'Landi', 'Affiliation': ''}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Zito', 'Affiliation': ''}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Zappasodi', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Lupoi', 'Affiliation': ''}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Rossini', 'Affiliation': ''}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Filippi', 'Affiliation': ''}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Tecchio', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20961'] 1607,31588902,Use of a Web-Based Dietary Assessment Tool (RiksmatenFlex) in Swedish Adolescents: Comparison and Validation Study.,"BACKGROUND A Web-based dietary assessment tool-RiksmatenFlex-was developed for the national dietary survey of adolescents in Sweden. OBJECTIVE This study aimed to describe the Web-based method RiksmatenFlex and to test the validity of the reported dietary intake by comparing dietary intake with 24-hour dietary recalls (recall interviews), estimated energy expenditure, and biomarkers. METHODS Adolescents aged 11-12, 14-15, and 17-18 years were recruited through schools. In total, 78 students had complete dietary information and were included in the study. Diet was reported a few weeks apart with either RiksmatenFlexDiet (the day before and a random later day) or recall interviews (face-to-face, a random day later by phone) in a cross-over, randomized design. At a school visit, weight and height were measured and blood samples were drawn for biomarker analyses. Students wore an accelerometer for 7 days for physical activity measurements. Dietary intake captured by both dietary methods was compared, and energy intake captured by both methods was compared with the accelerometer-estimated energy expenditure (EEest). Intake of whole grain wheat and rye and fruit and vegetables by both methods was compared with alkylresorcinol and carotenoid concentrations in plasma, respectively. RESULTS The mean of the reported energy intake was 8.92 (SD 2.77) MJ by RiksmatenFlexDiet and 8.04 (SD 2.67) MJ by the recall interviews (P=.01). Intake of fruit and vegetables was 224 (169) g and 227 (150) g, and whole grain wheat and rye intake was 12.4 (SD 13.2) g and 12.0 (SD 13.1) g, respectively; the intakes of fruit and vegetables as well as whole grain wheat and rye did not differ between methods. Intraclass correlation coefficients ranged from 0.57 for protein and carbohydrates to 0.23 for vegetables. Energy intake by RiksmatenFlexDiet was overreported by 8% (P=.03) but not by the recall interviews (P=.53) compared with EEest. The Spearman correlation coefficient between reported energy intake and EEest was 0.34 (P=.008) for RiksmatenFlexDiet and 0.16 (P=.21) for the recall interviews. Spearman correlation coefficient between whole grain wheat and rye and plasma total alkylresorcinol homologs was 0.36 (P=.002) for RiksmatenFlexDiet and 0.29 (P=.02) for the recall interviews. Spearman correlations between intake of fruit and vegetables and plasma carotenoids were weak for both dietary tools. The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02). CONCLUSIONS RiksmatenFlexDiet provides information on energy, fruit, vegetables, and whole grain wheat and rye intake, which is comparable with intake obtained from recall interviews in Swedish adolescents. The results are promising for cost-effective dietary data collection in upcoming national dietary surveys and other studies in Sweden. Future research should focus on how, and if, new technological solutions could reduce dietary reporting biases.",2019,"The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02). ","['Adolescents aged 11-12, 14-15, and 17-18 years were recruited through schools', 'adolescents in Sweden', 'Swedish Adolescents', 'Swedish adolescents', '78 students had complete dietary information and were included in the study']","['Web-Based Dietary Assessment Tool (RiksmatenFlex', 'RiksmatenFlexDiet']","['Energy intake by RiksmatenFlexDiet', 'plasma total alkylresorcinol homologs', 'mean of the reported energy intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0334944,"The strongest correlations were observed between fruit and vegetable intake and lutein/zeaxanthin for RiksmatenFlexDiet (0.46; P<.001) and for recall interviews (0.28; P=.02). ","[{'ForeName': 'Anna Karin', 'Initials': 'AK', 'LastName': 'Lindroos', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Petrelius Sipinen', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Axelsson', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Leanderson', 'Affiliation': 'Occupational and Environmental Medicine Center, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Arnemo', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Warensjö Lemming', 'Affiliation': 'Swedish National Food Agency, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/12572'] 1608,31530665,Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.,"OBJECTIVE Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy. RESEARCH DESIGN AND METHODS LixiLan-G, a randomized, open-label, 26-week trial, compared switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA 1c 7-9% (53-75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors. Adherence to randomized treatment was closely monitored throughout the study. RESULTS iGlarLixi ( n = 257) reduced HbA 1c more than continued GLP-1 RA therapy ( n = 257) from a baseline 7.8% (62 mmol/mol) in both to 6.7% (50 mmol/mol) and 7.4% (57 mmol/mol), respectively, at 26 weeks (least squares mean difference -0.6%; P < 0.0001). More iGlarLixi patients achieved HbA 1c <7% (53 mmol/mol) (62% vs. 26%; P < 0.0001) and the composite of HbA 1c <7% without documented symptomatic hypoglycemia (<54 mg/dL). Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy. CONCLUSIONS Switching to iGlarLixi improves glucose control for patients with type 2 diabetes insufficiently controlled on a maximum tolerated dose of a GLP-1 RA plus oral antihyperglycemic agents.",2019,"Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy. ","['type 2 diabetes', 'patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy', 'patients with type 2 diabetes', 'patients with type 2 diabetes and HbA 1c 7-9% (53-75 mmol/mol) taking maximum tolerated doses of a']","['GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors', 'iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA', 'iGlarLixi versus continuing prior GLP-1 RA', 'iGlarLixi', 'GLP-1 RA therapy', 'titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi', 'basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA']","['Nausea and vomiting rates', 'symptomatic hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",75.0,0.0675775,"Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy. ","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA lblonde@ochsner.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'University of Pisa School of Medicine, Pisa, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henry', 'Affiliation': 'University of California, San Diego, and Center for Metabolic Research, Veterans Affairs San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Shehadeh', 'Affiliation': 'Endocrinology, Diabetes, and Metabolism Institute, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Souhami', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Sanofi, Beijing, China.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}]",Diabetes care,['10.2337/dc19-1357'] 1609,32076003,Short-term and long-term effects of a social network intervention on friendships among university students.,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education. Network interventions can aim at providing contact opportunities in school settings to prevent the social isolation of individuals and facilitate integration between otherwise segregated social groups. We investigate the short-term and long-term effects of one specific network intervention in an undergraduate cohort freshly admitted to an engineering department ([Formula: see text]). In this intervention, we randomly assigned students into small groups at an introduction event two months prior to their first day at university. The groups were designed to increase mixed-gender contact opportunities. Two months after the intervention, we find a higher rate of friendships, common friends, and mixed-gender friendships in pairs of students who were assigned to the same group than in pairs from different groups (short-term effects). These effects gradually diminish over the first academic year (long-term effects). Using stochastic actor-oriented models, we investigate the long-term trajectory of the intervention effects, while considering alternative network processes, such as reciprocity, transitivity, homophily, and popularity. The results suggest that even though the induced friendship ties are less stable than other friendships, they may serve as early seeds for complex social network processes. Our study shows that simple network interventions can have a pronounced short-term effect and indirect long-term effects on the evolution and structure of student communities.",2020,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education.","['undergraduate cohort freshly admitted to an engineering department ([Formula', 'friendships among university students']","['specific network intervention', 'social network intervention']",[],"[{'cui': 'C0014279', 'cui_str': 'Engineerings'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],,0.0271311,"Informal social relations, such as friendships, are crucial for the well-being and success of students at all levels of education.","[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Boda', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland. zsofia.boda@gess.ethz.ch.'}, {'ForeName': 'Timon', 'Initials': 'T', 'LastName': 'Elmer', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Vörös', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stadtfeld', 'Affiliation': 'Chair of Social Networks, Department of Humanities, Social and Political Sciences, ETH Zürich, Weinbergstrasse 109, Zürich, 8006, Switzerland. christoph.stadtfeld@ethz.ch.'}]",Scientific reports,['10.1038/s41598-020-59594-z'] 1610,20143387,Distortion correction for diffusion-weighted MRI tractography and fMRI in the temporal lobes.,"Single shot echo-planar imaging (EPI) sequences are currently the most commonly used sequences for diffusion-weighted imaging (DWI) and functional magnetic resonance imaging (fMRI) as they allow relatively high signal to noise with rapid acquisition time. A major drawback of EPI is the substantial geometric distortion and signal loss that can occur due to magnetic field inhomogeneities close to air-tissue boundaries. If DWI-based tractography and fMRI are to be applied to these regions, then the distortions must be accurately corrected to achieve meaningful results. We describe robust acquisition and processing methods for correcting such distortions in spin echo (SE) EPI using a variant of the reversed direction k space traversal method with a number of novel additions. We demonstrate that dual direction k space traversal with maintained diffusion-encoding gradient strength and direction results in correction of the great majority of eddy current-associated distortions in DWI, in addition to those created by variations in magnetic susceptibility. We also provide examples to demonstrate that the presence of severe distortions cannot be ignored if meaningful tractography results are desired. The distortion correction routine was applied to SE-EPI fMRI acquisitions and allowed detection of activation in the temporal lobe that had been previously found using PET but not conventional fMRI.",2010,The distortion correction routine was applied to SE-EPI fMRI acquisitions and allowed detection of activation in the temporal lobe that had been previously found using PET but not conventional fMRI.,[],"['EPI', 'Single shot echo-planar imaging (EPI) sequences']",[],[],"[{'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",[],,0.0360212,The distortion correction routine was applied to SE-EPI fMRI acquisitions and allowed detection of activation in the temporal lobe that had been previously found using PET but not conventional fMRI.,"[{'ForeName': 'Karl V', 'Initials': 'KV', 'LastName': 'Embleton', 'Affiliation': 'Imaging Science and Biomedical Engineering, School of Cancer and Imaging Sciences, University of Manchester, Manchester M13 9PT, United Kingdom. karl.embleton@manchester.ac.uk'}, {'ForeName': 'Hamied A', 'Initials': 'HA', 'LastName': 'Haroon', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Matthew A Lambon', 'Initials': 'MA', 'LastName': 'Ralph', 'Affiliation': ''}, {'ForeName': 'Geoff J M', 'Initials': 'GJ', 'LastName': 'Parker', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20959'] 1611,20127873,Individual differences in socioaffective skills influence the neural bases of fear processing: the case of alexithymia.,"Being exposed to fear signals makes us feel threatened and prompts us to prepare an adaptive response. In our previous studies, we suggested that amygdala (AMG) and premotor cortex (PM) play a role in the preparation of the observers' motor response required by the situation. The present experiment aimed at assessing how interindividual differences in alexithymia--a personality trait associated with deficits in emotional reactivity and regulation--influence the neural network associated with the perception of fear. Using fMRI, we scanned 34 healthy subjects while they were passively observing fearful body expressions. Applying a dimensional approach, we performed correlation analyses between fear-related brain areas and alexithymia scores among all participants. Using a categorical approach, we conducted a between-group comparison (13 high vs. 12 low-alexithymia subjects). Our results were threefold. First, the right AMG activity in response to fearful stimuli was negatively correlated with the level of difficulty to identify emotions. Second, PM activity was linked to reduced subjective emotional reactivity. Third, the between-group comparison revealed greater activity in anterior cingulate cortex (ACC) for high than low-alexithymia scorers. Moreover, the relationship between ACC and PM was in opposite direction in individuals with high (negative link) and low (positive link) alexithymia. Therefore, compared to our previous findings, we hereby further reveal how ACC interacts with PM to sustain self-regulation of one's own emotional state in response to threatening social signals. Moreover, this neural mechanism could account for the description of the ""cold-blooded"" personality of individuals with alexithymia.",2010,"Third, the between-group comparison revealed greater activity in anterior cingulate cortex (ACC) for high than low-alexithymia scorers.",['34 healthy subjects while they were passively observing fearful body expressions'],[],"['greater activity in anterior cingulate cortex (ACC', 'fear-related brain areas and alexithymia scores', 'subjective emotional reactivity', 'PM activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",34.0,0.0138662,"Third, the between-group comparison revealed greater activity in anterior cingulate cortex (ACC) for high than low-alexithymia scorers.","[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Pouga', 'Affiliation': 'Cognitives Neurosciences Laboratory, INSERM U960 and DEC-Ecole Normale Supérieure, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Berthoz', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'de Gelder', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grèzes', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20953'] 1612,20660280,Accelerator mass spectrometry can be used to assess vitamin A metabolism quantitatively in boys in a community setting.,"A survey indicated that high-dose vitamin A (HD-VA) supplements had no apparent effect on vitamin A (VA) status, assessed by serum retinol concentrations, of Zambian children lt 5 y of age. To explore possible reasons for the lack of response, we quantified absorption, retention, and urinary elimination of either a single HD-VA supplement (209.8 micromol; 60 mg) or a smaller dose of stable isotope (SI)-labeled VA (17.5 micromol; 5 mg), which was used to estimate VA pool size, in 3- to 4-y-old Zambian boys (n = 4 for each VA dose). A tracer dose of [(14)C(2)]-labeled VA (0.925 kBq; 25 nCi) was coadministered with the HD-VA supplement or SI-labeled VA, and 24-h stool and urine samples were collected for 3 and 7 consecutive days, respectively, and 24-h urine samples at 4 later time points. Accelerator MS was used to quantify (14)C in stool and urine. Estimates of absorption, retention, and the urinary elimination rate (UER) were 83.8 +/- 7.1%, 76.3 +/- 6.7%, and 1.9 +/- 0.6%/d, respectively, for the HD-VA supplement and 76.5 +/- 9.5%, 71.1 +/- 9.4%, and 1.8 +/- 1.2%/d, respectively, for the SI-labeled VA. Mean estimates of absorption, retention, and the UER did not differ by size of the VA dose administered. Estimated absorption and retention were negatively associated with reported fever (r = minus 0.83; P = 0.011). The HD-VA supplement and SI-labeled VA were adequately absorbed, retained, and utilized in apparently healthy Zambian preschool-age boys; absorption and retention may be affected by recent fever.",2010,Estimated absorption and retention were negatively associated with reported fever (r = minus 0.83; P = 0.011).,[],['stable isotope (SI)-labeled VA'],"['vitamin A (VA) status, assessed by serum retinol concentrations', 'Mean estimates of absorption, retention, and the UER', 'Estimated absorption and retention', 'absorption, retention, and the urinary elimination rate (UER', 'fever']",[],"[{'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.141613,Estimated absorption and retention were negatively associated with reported fever (r = minus 0.83; P = 0.011).,"[{'ForeName': 'Emmanuel K', 'Initials': 'EK', 'LastName': 'Aklamati', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Modest', 'Initials': 'M', 'LastName': 'Mulenga', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Dueker', 'Affiliation': ''}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buchholz', 'Affiliation': ''}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Peerson', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kafwembe', 'Affiliation': ''}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Haskell', 'Affiliation': ''}]",The Journal of nutrition,['10.3945/jn.110.125500'] 1613,31522033,Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours.,"BACKGROUND Brivanib is a selective inhibitor of vascular endothelial growth factor and fibroblast growth factor (FGF) signalling. We performed a phase II randomised discontinuation trial of brivanib in 7 tumour types (soft-tissue sarcomas [STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer and transitional cell carcinoma [TCC]). PATIENTS AND METHODS During a 12-week open-label lead-in period, patients received brivanib 800 mg daily and were evaluated for FGF2 status by immunohistochemistry. Patients with stable disease at week 12 were randomised to brivanib or placebo. A study steering committee evaluated week 12 response to determine if enrolment in a tumour type would continue. The primary objective was progression-free survival (PFS) for brivanib versus placebo in patients with FGF2-positive tumours. RESULTS A total of 595 patients were treated, and stable disease was observed at the week 12 randomisation point in all tumour types. Closure decisions were made for breast cancer, pancreatic cancer, NSCLC, gastric cancer and TCC. Criteria for expansion were met for STS and ovarian cancer. In 53 randomised patients with STS and FGF2-positive tumours, the median PFS was 2.8 months for brivanib and 1.4 months for placebo (hazard ratio [HR]: 0.58, p = 0.08). For all randomised patients with sarcomas, the median PFS was 2.8 months (95% confidence interval [CI]: 1.4-4.0) for those treated with brivanib compared with 1.4 months (95% CI: 1.3-1.6) for placebo (HR = 0.64, 95% CI: 0.38-1.07; p = 0.09). In the 36 randomised patients with ovarian cancer and FGF2-positive tumours, the median PFS was 4.0 (95% CI: 2.6-4.2) months for brivanib and 2.0 months (95% CI: 1.2-2.7) for placebo (HR: 0.56, 95% CI: 0.26-1.22). For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11). CONCLUSION Brivanib demonstrated activity in STS and ovarian cancer with an acceptable safety profile. FGF2 expression, as defined in the protocol, is not a predictive biomarker of the efficacy of brivanib.",2019,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11). ","['Patients with stable disease at week 12', '595 patients', '36 randomised patients with ovarian cancer and FGF2-positive tumours', '7 tumour types (soft-tissue sarcomas\xa0[STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer\xa0and transitional cell carcinoma [TCC', '53 randomised patients with STS and FGF2-positive tumours', 'patients with FGF2-positive tumours', 'patients with advanced solid tumours']","['brivanib or placebo', 'brivanib', 'placebo', 'brivanib 800\xa0mg daily and were evaluated for FGF2 status by immunohistochemistry', 'brivanib versus placebo']","['progression-free survival (PFS', 'median PFS', 'FGF2 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2700604', 'cui_str': 'brivanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",595.0,0.421179,"For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6-4.2) and was 2.0 months (95% CI: 1.2-2.7) in those randomised to placebo (HR = 0.54, 95% CI: 0.25-1.17; p = 0.11). ","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom. Electronic address: robin.jones4@nhs.net.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Medioni', 'Affiliation': 'Hôpital Européen Georges Pompidou, Paris, France; Paris-Descartes University, Paris, France.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'DeJonge', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rudin', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sawyer', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Khayat', 'Affiliation': 'Petrie-Salpetriere Hospital, Paris, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Judith M P G M', 'Initials': 'JMPGM', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'T R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Brockstein', 'Affiliation': 'North Shore University Health System, Evanston, IL, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'DeGreve', 'Affiliation': 'University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Baurain', 'Affiliation': 'Centre du Cancer, Cu Saint-Luc/UCL, Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Monter Cancer Center, Lake Success, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Adamo"", 'Affiliation': 'Eisai Inc, Woodcliff Lake, NJ Previously Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dickson', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Undevia', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Geary', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Janisch', 'Affiliation': 'University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Albiruni R', 'Initials': 'AR', 'LastName': 'Abdul Razak', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vitfell-Rasmussen', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Walters', 'Affiliation': 'Intensity Therapeutics Inc, Westport, CT Previously BMS, USA.'}, {'ForeName': 'Stan B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Royal Marsden Hospital, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.024'] 1614,30690731,The experience-based format of probability improves probability estimates: The moderating role of individual differences in numeracy.,"People with low statistical numeracy have difficulties understanding numerical information. For instance, they often misunderstand the probability of experiencing side effects, which could reduce adherence to medical treatments. We investigated whether presenting information about probability using a method based on the direct experience of events influences the accuracy of probability estimates compared to viewing a static numerical description of the same information. Participants completed a numeracy test and were randomly assigned to one of two conditions. In the description-based probability condition, participants were presented with 24 binomial distributions consisting of a target stimulus ""X"" and a distractor stimulus ""·"" in the form of odds (the distribution ""7 × 13 ·"" is an example of a 35% probability: here the target [distractor] stimulus was present 7[13] times in a 20-stimulus distribution). In the experience-based probability condition, participants observed the same information but the stimuli were randomly arranged and displayed sequentially. Participants in both conditions estimated the probability of the target stimulus in each trial. In the experience-based format participants with low numeracy made more accurate probability estimates in comparison to the description-based format. In contrast, accuracy in participants with high numeracy was similar in the two formats.",2020,In the experience-based format participants with low numeracy made more accurate probability estimates in comparison to the description-based format.,[],['target [distractor'],[],[],[],[],,0.0596456,In the experience-based format participants with low numeracy made more accurate probability estimates in comparison to the description-based format.,"[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Traczyk', 'Affiliation': 'Department of Economic Psychology, SWPS University of Social Sciences and Humanities, Wroclaw Faculty of Psychology, Wroclaw, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Sobkow', 'Affiliation': 'Department of Economic Psychology, SWPS University of Social Sciences and Humanities, Wroclaw Faculty of Psychology, Wroclaw, Poland.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Matukiewicz', 'Affiliation': 'Department of Economic Psychology, SWPS University of Social Sciences and Humanities, Wroclaw Faculty of Psychology, Wroclaw, Poland.'}, {'ForeName': 'Dafina', 'Initials': 'D', 'LastName': 'Petrova', 'Affiliation': 'Andalusian School of Public Health (EASP), Granada, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Garcia-Retamero', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12566'] 1615,18548559,Influence of ocular filtering in EEG data on the assessment of drug-induced effects on the brain.,"Ocular artifacts in EEG signals affect the interpretation of clinical study results. The aim of this study was to assess the influence of automatic ocular filtering procedures in the conclusions drawn from a pharmaco-EEG trial. Regression analysis, gold standard, and blind source separation (BSS), Second Order Blind Identification algorithm, ocular filtering procedures were compared using time, frequency, topographic and tomographic brain mapping approaches and pharmacokinetic-pharmacodynamic (PK-PD) relationships. Data consisted of EEGs obtained from 20 volunteers who received single oral doses of haloperidol 3 mg, risperidone 1 mg, olanzapine 5 mg and placebo in a randomized cross-over double-blind design. Although the BSS-based technique preserved brain activity more than regression analysis in anterior leads, in general, topographic significance probability maps globally showed similar results with both methods for most spectral variables. However, different results were obtained when using whole multi-channel information for studying drug effects in the brain: (i) higher correlations between PK and PD time courses showing that BSS allowed estimation of spectral variables more accurately related to drug effects and (ii) larger and more symmetric drug related tomographic LORETA maps showing that BSS led to results that were more neurophysiopharmacologically sound. Definitely, the BSS-based procedure is an effective and efficient preprocessing method to remove ocular artifacts from EEG data. The selection of the ocular filtering procedure could determine different results whose impact depends on the evaluating tool applied to analyze the pharmaco-EEG data.",2009,"Although the BSS-based technique preserved brain activity more than regression analysis in anterior leads, in general, topographic significance probability maps globally showed similar results with both methods for most spectral variables.",['20 volunteers who received single oral doses of'],"['haloperidol 3 mg, risperidone 1 mg, olanzapine 5 mg and placebo', 'automatic ocular filtering procedures']","['time, frequency, topographic and tomographic brain mapping approaches and pharmacokinetic-pharmacodynamic (PK-PD) relationships']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0989713', 'cui_str': 'Risperidone 1 MG'}, {'cui': 'C1597589', 'cui_str': 'olanzapine 5 MG [Zyprexa]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0006117', 'cui_str': 'Brain Mapping'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]",20.0,0.0252907,"Although the BSS-based technique preserved brain activity more than regression analysis in anterior leads, in general, topographic significance probability maps globally showed similar results with both methods for most spectral variables.","[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': 'Department of Automatic Control, Biomedical Engineering Research Center, Universitat Politècnica de Catalunya, C/Pau Gargallo 5, Barcelona, Spain. sergio.romero-lafuente@upc.edu'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Mañanas', 'Affiliation': ''}, {'ForeName': 'Manel J', 'Initials': 'MJ', 'LastName': 'Barbanoj', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20614'] 1616,31639813,Combined Internet-Based Cognitive-Behavioral and Chronobiological Intervention for Insomnia: A Randomized Controlled Trial.,,2020,,['Insomnia'],['Combined Internet-Based Cognitive-Behavioral and Chronobiological Intervention'],[],"[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.14954,,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dekker', 'Affiliation': 'Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen S', 'Initials': 'JS', 'LastName': 'Benjamins', 'Affiliation': 'Department of Social, Health and Organisational Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Maksimovic', 'Affiliation': 'Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Filardi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences - DIBINEM, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Winni F', 'Initials': 'WF', 'LastName': 'Hofman', 'Affiliation': 'Brain and Cognition Group, Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam and EMGO Institute for Health Care and Research, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'Van Someren', 'Affiliation': 'Netherlands Institute for Neuroscience, Amsterdam, The Netherlands, e.van.someren@nin.knaw.nl.'}]",Psychotherapy and psychosomatics,['10.1159/000503570'] 1617,31860101,"An Educational Intervention for Improving Infant Sleep Duration-Why Won't You Sleep, Baby?",,2019,,[],['Educational Intervention'],[],[],[],[],,0.0334539,,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""Health Services Research Group, Murdoch Children's Research Institute, Parkville, Australia.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.18061'] 1618,18571795,The salient characteristics of the central effects of acupuncture needling: limbic-paralimbic-neocortical network modulation.,"Human and animal studies suggest that acupuncture produces many beneficial effects through the central nervous system. However, the neural substrates of acupuncture actions are not completely clear to date. fMRI studies at Hegu (LI4) and Zusanli (ST36) indicated that the limbic system may play an important role for acupuncture effects. To test if this finding applies to other major classical acupoints, fMRI was performed on 10 healthy adults during manual acupuncture at Taichong (LV3), Xingjian (LV2), Neiting (ST44), and a sham point on the dorsum of the left foot. Although certain differences could be observed between real and sham points, the hemodynamic response (BOLD signal changes) and psychophysical response (sensory experience) to acupuncture were generally similar for all four points. Acupuncture produced extensive deactivation of the limbic-paralimbic-neocortical system. Clusters of deactivated regions were seen in the medial prefrontal cortex (frontal pole, pregenual cingulate), the temporal lobe (amygdala, hippocampus, and parahippocampus) and the posterior medial cortex (precuneus, posterior cingulate). The sensorimotor cortices (somatosensory cortices, supplementary motor cortex), thalamus and occasional paralimbic structures such as the insula and anterior middle cingulate cortex showed activation. Our results provide additional evidence in support of previous reports that acupuncture modulates the limbic-paralimbic-neocortical network. We hypothesize that acupuncture may mediate its antipain, antianxiety, and other therapeutic effects via this intrinsic neural circuit that plays a central role in the affective and cognitive dimensions of pain as well as in the regulation and integration of emotion, memory processing, autonomic, endocrine, immunological, and sensorimotor functions.",2009,"Clusters of deactivated regions were seen in the medial prefrontal cortex (frontal pole, pregenual cingulate), the temporal lobe (amygdala, hippocampus, and parahippocampus) and the posterior medial cortex (precuneus, posterior cingulate).",['10 healthy adults during'],"['Hegu (LI4) and Zusanli (ST36', 'acupuncture', 'acupuncture needling: limbic-paralimbic-neocortical network modulation', 'manual acupuncture at Taichong (LV3), Xingjian (LV2), Neiting (ST44', 'Acupuncture']","['hemodynamic response (BOLD signal changes) and psychophysical response (sensory experience', 'medial prefrontal cortex (frontal pole, pregenual cingulate), the temporal lobe (amygdala, hippocampus, and parahippocampus) and the posterior medial cortex (precuneus, posterior cingulate', 'sensorimotor cortices (somatosensory cortices, supplementary motor cortex), thalamus and occasional paralimbic structures such as the insula and anterior middle cingulate cortex showed activation']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0450533', 'cui_str': 'ST36 (body structure)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle, device (physical object)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0450541', 'cui_str': 'ST44 (body structure)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0521114', 'cui_str': 'Infrequent (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}]",10.0,0.082308,"Clusters of deactivated regions were seen in the medial prefrontal cortex (frontal pole, pregenual cingulate), the temporal lobe (amygdala, hippocampus, and parahippocampus) and the posterior medial cortex (precuneus, posterior cingulate).","[{'ForeName': 'Jiliang', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Radiology, Guang An Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China. fang@nmr.mgh.harvard.edu'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'Erika E', 'Initials': 'EE', 'LastName': 'Nixon', 'Affiliation': ''}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yanshuang', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kathleen Kin-Sang', 'Initials': 'KK', 'LastName': 'Hui', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20583'] 1619,18571794,Alcohol dose effects on brain circuits during simulated driving: an fMRI study.,"Driving while intoxicated remains a major public health hazard. Driving is a complex task involving simultaneous recruitment of multiple cognitive functions. The investigators studied the neural substrates of driving and their response to different blood alcohol concentrations (BACs), using functional magnetic resonance imaging (fMRI) and a virtual reality driving simulator. We used independent component analysis (ICA) to isolate spatially independent and temporally correlated driving-related brain circuits in 40 healthy, adult moderate social drinkers. Each subject received three individualized, separate single-blind doses of beverage alcohol to produce BACs of 0.05% (moderate), 0.10% (high), or 0% (placebo). 3 T fMRI scanning and continuous behavioral measurement occurred during simulated driving. Brain function was assessed and compared using both ICA and a conventional general linear model (GLM) analysis. ICA results replicated and significantly extended our previous 1.5T study (Calhoun et al. [2004a]: Neuropsychopharmacology 29:2097-2017). GLM analysis revealed significant dose-related functional differences, complementing ICA data. Driving behaviors including opposite white line crossings and mean speed independently demonstrated significant dose-dependent changes. Behavior-based factors also predicted a frontal-basal-temporal circuit to be functionally impaired with alcohol dosage across baseline scaled, good versus poorly performing drivers. We report neural correlates of driving behavior and found dose-related spatio-temporal disruptions in critical driving-associated regions including the superior, middle and orbito frontal gyri, anterior cingulate, primary/supplementary motor areas, basal ganglia, and cerebellum. Overall, results suggest that alcohol (especially at high doses) causes significant impairment of both driving behavior and brain functionality related to motor planning and control, goal directedness, error monitoring, and memory.",2009,"We report neural correlates of driving behavior and found dose-related spatio-temporal disruptions in critical driving-associated regions including the superior, middle and orbito frontal gyri, anterior cingulate, primary/supplementary motor areas, basal ganglia, and cerebellum.","['40 healthy, adult moderate social drinkers']","['0% (placebo', 'functional magnetic resonance imaging (fMRI) and a virtual reality driving simulator']","['Brain function', '3 T fMRI scanning and continuous behavioral measurement', 'brain circuits', 'driving behavior and brain functionality related to motor planning and control, goal directedness, error monitoring, and memory']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0337676', 'cui_str': 'Social drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0384212,"We report neural correlates of driving behavior and found dose-related spatio-temporal disruptions in critical driving-associated regions including the superior, middle and orbito frontal gyri, anterior cingulate, primary/supplementary motor areas, basal ganglia, and cerebellum.","[{'ForeName': 'Shashwath A', 'Initials': 'SA', 'LastName': 'Meda', 'Affiliation': 'Olin Neuropsychiatry Research Center, Institute of Living at Hartford Hospital, Connecticut, USA. smeda01@harthosp.org'}, {'ForeName': 'Vince D', 'Initials': 'VD', 'LastName': 'Calhoun', 'Affiliation': ''}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Astur', 'Affiliation': ''}, {'ForeName': 'Beth M', 'Initials': 'BM', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ruopp', 'Affiliation': ''}, {'ForeName': 'Godfrey D', 'Initials': 'GD', 'LastName': 'Pearlson', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20591'] 1620,19780041,Evidence for modulation of opioidergic activity in central vestibular processing: A [(18)F] diprenorphine PET study.,"Animal and functional imaging studies had identified cortical structures such as the parieto-insular vestibular cortex, the retro-insular cortex, or the anterior cingulate cortex belonging to a vestibular cortical network. Basic animal studies revealed that endorphins might be important transmitters involved in cerebral vestibular processing. The aim of the present study was therefore to analyse whether the opioid system is involved in vestibular neurotransmission of humans or not. Changes in opioid receptor availability during caloric air stimulation of the right ear were studied with [(18)F] Fluoroethyl-diprenorphine ([(18)F]FEDPN) PET scans in 10 right-handed healthy volunteers and compared to a control condition. Decrease in receptor availability to [(18)F]FEDPN during vestibular stimulation in comparison to the control condition was significant at the right posterior insular cortex and the postcentral region indicating more endogenous opioidergic binding in these regions during stimulation. These data give evidence that the opioidergic system plays a role in the right hemispheric dominance of the vestibular cortical system in right-handers.",2010,Decrease in receptor availability to [(18)F]FEDPN during vestibular stimulation in comparison to the control condition was significant at the right posterior insular cortex and the postcentral region indicating more endogenous opioidergic binding in these regions during stimulation.,['10 right-handed healthy volunteers'],['18)F] Fluoroethyl-diprenorphine ([(18)F]FEDPN) PET scans'],['receptor availability'],"[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0012572', 'cui_str': '6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha,alpha-dimethyl-, (5alpha,7alpha)-'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]",,0.0210196,Decrease in receptor availability to [(18)F]FEDPN during vestibular stimulation in comparison to the control condition was significant at the right posterior insular cortex and the postcentral region indicating more endogenous opioidergic binding in these regions during stimulation.,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Baier', 'Affiliation': 'Department of Neurology, University of Mainz, Langenbeckstr. 1, 55131 Mainz, Germany. baierb@uni-mainz.de'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bense', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Birklein', 'Affiliation': ''}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Buchholz', 'Affiliation': ''}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mischke', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schreckenberger', 'Affiliation': ''}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Dieterich', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20886'] 1621,31597669,"Effect of Methylprednisolone or Zoledronic Acid on Resolution of Active Charcot Neuroarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study.",,2019,,['Diabetes'],"['Placebo', 'Methylprednisolone or Zoledronic Acid']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]",[],,0.550114,,"[{'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Das', 'Affiliation': 'Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Bhansali', 'Affiliation': 'Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside Hospital NHS Foundation Trust and University of Manchester, Ashton under Lyne, U.K.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India ashuendo@gmail.com.'}]",Diabetes care,['10.2337/dc19-1659'] 1622,29757433,The Effects of Useful Field of View Training on Brain Activity and Connectivity.,"OBJECTIVES Useful Field of View training (UFOVt) is an adaptive computerized cognitive intervention that improves visual attention and transfers to maintained health and everyday functioning in older adults. Although its efficacy is well established, the neural mechanisms underlying this intervention are unknown. This pilot study used functional MRI (fMRI) to explore neural changes following UFOVt. METHOD Task-driven and resting-state fMRI were used to examine changes in brain activity and connectivity in healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10). RESULTS UFOVt resulted in reduced task-driven activity in the majority of regions of interest (ROIs) associated with task performance, CSA resulted in reduced activity in one ROI, and there were no changes within the NC group. Relative to NC, UFOVt reduced activity in ROIs involved in effortful information processing. There were no other significant between-group task-based differences. Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC. DISCUSSION UFOVt enhances connections needed for visual attention. Together with prior work, this study provides evidence that improvement of the brain's visual attention efficiency is one mechanism underlying UFOVt.",2019,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC. ","['healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10', 'older adults']","['functional MRI (fMRI', 'View Training', 'View training (UFOVt', 'Method\n\n\nTask-driven and resting-state fMRI']","['executive function and visual attention', 'Brain Activity and Connectivity', 'brain activity and connectivity', 'reduced task-driven activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",13.0,0.0373196,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC. ","[{'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': 'Department of Human Development and Family Studies, University Park.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Whitaker', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Hicks', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham.'}, {'ForeName': 'Shaadee', 'Initials': 'S', 'LastName': 'Samimy', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dennis', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Visscher', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby041'] 1623,31800558,"Letter to the Editor Following ""Prospective Clinical Trial Comparing Outcome Measures Between Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al. Annals of Plastic Surgery, 2011.",,2020,,[],[],"['Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al']",[],[],[],,0.0242814,,"[{'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Singapore Clinical Research Institute, Singapore qingshu.lu@scri.edu.sg Department of Plastic, Reconstructive, and Aesthetic Surgery, Singapore General Hospital, Singapore. Cleft and Craniofacial Centre, KK Women's and Children Hospital, Singapore. SingHealth Duke-NUS Academic Medical Centre, Singapore. Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.""}, {'ForeName': 'Seng Teik', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Selena Ee-Li', 'Initials': 'SE', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Say Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Machin', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002078'] 1624,31809290,CORR Insights®: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.186264,,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Grecula', 'Affiliation': 'M. J. Grecula, University of Texas Medical Branch, Department of Orthopaedic Surgery and Rehabilitation, Galveston, TX, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001050'] 1625,31678013,"Regarding the article entitled ""A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial"".",,2020,,['adults with cystic fibrosis'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],[],,0.180237,,"[{'ForeName': 'Zhe Hui', 'Initials': 'ZH', 'LastName': 'Hoo', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Sheffield Adult CF Centre, Northern General Hospital, Sheffield, UK. Electronic address: z.hoo@sheffield.ac.uk.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Wildman', 'Affiliation': 'Sheffield Adult CF Centre, Northern General Hospital, Sheffield, UK; School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. Electronic address: martin.wildman3@nhs.net.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.017'] 1626,18726908,Single dose of a dopamine agonist impairs reinforcement learning in humans: evidence from event-related potentials and computational modeling of striatal-cortical function.,"Animal findings have highlighted the modulatory role of phasic dopamine (DA) signaling in incentive learning, particularly in the acquisition of reward-related behavior. In humans, these processes remain largely unknown. In a recent study, we demonstrated that a single low dose of a D2/D3 agonist (pramipexole)-assumed to activate DA autoreceptors and thus reduce phasic DA bursts-impaired reward learning in healthy subjects performing a probabilistic reward task. The purpose of this study was to extend these behavioral findings using event-related potentials and computational modeling. Compared with the placebo group, participants receiving pramipexole showed increased feedback-related negativity to probabilistic rewards and decreased activation in dorsal anterior cingulate regions previously implicated in integrating reinforcement history over time. Additionally, findings of blunted reward learning in participants receiving pramipexole were simulated by reduced presynaptic DA signaling in response to reward in a neural network model of striatal-cortical function. These preliminary findings offer important insights on the role of phasic DA signals on reinforcement learning in humans and provide initial evidence regarding the spatiotemporal dynamics of brain mechanisms underlying these processes.",2009,"Compared with the placebo group, participants receiving pramipexole showed increased feedback-related negativity to probabilistic rewards and decreased activation in dorsal anterior cingulate regions previously implicated in integrating reinforcement history over time.","['healthy subjects performing a probabilistic reward task', 'humans']","['pramipexole', 'placebo', 'D2/D3 agonist (pramipexole)-assumed', 'dopamine agonist']",['phasic DA bursts-impaired reward learning'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0074710', 'cui_str': 'Pramipexole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}]","[{'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0521612,"Compared with the placebo group, participants receiving pramipexole showed increased feedback-related negativity to probabilistic rewards and decreased activation in dorsal anterior cingulate regions previously implicated in integrating reinforcement history over time.","[{'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Santesso', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02138, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'Erika C', 'Initials': 'EC', 'LastName': 'Schetter', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Bogdan', 'Affiliation': ''}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20642'] 1627,31567287,"CORR Insights®: Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.",,2020,,[],['CORR Insights®'],[],[],[],[],,0.24247,,"[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Dorr', 'Affiliation': 'L. D. Dorr, Dorr Institute for Research and Education, Pasadena, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000969'] 1628,31583947,The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements.,"Background. Previous research found that adding a single piece of quantitative information about prescription drug benefits to direct-to-consumer (DTC) ads helps consumers understand how well the drug works. However, drug information often includes quantitative information on multiple benefit outcomes and risks. Thus, we examined whether consumer understanding was similarly improved when DTC television ads include varying amounts of quantitative information. Methods. We randomly assigned participants (945 Internet panelists ≥ 60 years old) to view 1 of 9 fictitious prescription drug television ads that varied the presentation of quantitative information for benefits (none, single outcome, 2 outcomes) and risks (none, 1 risk category, 3 risk categories) and then measured gist and verbatim recall/estimation and drug perceptions. Results. Adding a single benefit outcome and a single risk category replicated past results. Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting 2 benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category. Limitations. This study may have limited generalizability because it examined an ad for only 1 medical condition. Conclusions. There are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug's risks.",2019,"Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions.",[],[],"['verbatim recall', 'gist and verbatim recall and affected drug perceptions']",[],[],"[{'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",945.0,0.0315478,"Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions.","[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Lynch', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'RTI International, Research Triangle Park, NC, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X19875946'] 1629,31625915,Pulmonary artery denervation - the time has come for a multicentre blinded randomised controlled trial.,,2019,,[],[],[],[],[],[],,0.36727,,"[{'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJV15I8A122'] 1630,31685555,Minimally invasive interval cytoreductive surgery: it's time for a randomized trial.,,2019,,[],['Minimally invasive interval cytoreductive surgery'],[],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}]",[],,0.0524414,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Department of Obstetrics and Gynecology and Herbert Irving Comprehensive Cancer Center, Columbia University, New York Presbyterian Hospital, New York City, New York, USA.'}, {'ForeName': 'Jose Alejandro', 'Initials': 'JA', 'LastName': 'Rauh-Hain', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States jarauh@mdanderson.org.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000971'] 1631,32067684,Extended induction chemotherapy does not improve the outcome for high-risk neuroblastoma patients: results of the randomized open-label GPOH trial NB2004-HR.,"BACKGROUND Long-term survival of high-risk neuroblastoma patients is still below 50% despite intensive multimodal treatment. This trial aimed to address whether the addition of two topotecan-containing chemotherapy courses compared to standard induction therapy improves event-free survival (EFS) of these patients. PATIENTS AND METHODS An open-label, multicenter, prospective randomized controlled trial was carried out at 58 hospitals in Germany and Switzerland. Patients aged 1-21 years with stage 4 neuroblastoma and patients aged 6 months to 21 years with MYCN-amplified tumors were eligible. The primary endpoint was EFS. Patients were randomly assigned to standard induction therapy with six chemotherapy courses or to experimental induction chemotherapy starting with two additional courses of topotecan, cyclophosphamide, and etoposide followed by standard induction chemotherapy (eight courses in total). After induction chemotherapy, all patients received high-dose chemotherapy with autologous hematopoietic stem cell rescue and isotretinoin for consolidation. Radiotherapy was applied to patients with active tumors at the end of induction chemotherapy. RESULTS Of 536 patients enrolled in the trial, 422 were randomly assigned to the control arm (n = 211) and the experimental arm (n = 211); the median follow-up time was 3.32 years (interquartile range 1.65-5.92). At data lock, the 3-year EFS of experimental and control patients was 34% and 32% [95% confidence Interval (CI) 28% to 40% and 26% to 38%; P = 0.258], respectively. Similarly, the 3-year overall survival of the patients did not differ [54% and 48% (95% CI 46% to 62% and 40% to 56%), respectively; P = 0.558]. The response to induction chemotherapy was not different between the arms. The median number of non-fatal toxicities per patient was higher in the experimental group while the median number of toxicities per chemotherapy course was not different. CONCLUSION While the burden for the patients was increased by prolonging the induction chemotherapy and the toxicity, the addition of two topotecan-containing chemotherapy courses did not improve the EFS of high-risk neuroblastoma patients and thus cannot be recommended. CLINICAL TRIALS. GOV NUMBER NCT number 03042429.",2020,"The median number of non-fatal toxicities per patient was higher in the experimental group while the median number of toxicities per chemotherapy course was not different. ","['536 patients enrolled in the trial', '58 hospitals in Germany and Switzerland', 'Patients aged 1-21 years with stage 4 neuroblastoma and patients aged 6 months to 21 years with MYCN-amplified tumors were eligible', 'high-risk neuroblastoma patients']","['Extended induction chemotherapy', 'topotecan-containing chemotherapy', 'standard induction therapy', 'standard induction therapy with six chemotherapy courses or to experimental induction chemotherapy starting with two additional courses of topotecan, cyclophosphamide, and etoposide followed by standard induction chemotherapy', 'high-dose chemotherapy with autologous hematopoietic stem cell rescue and isotretinoin for consolidation', 'Radiotherapy']","['median number of non-fatal toxicities', '3-year EFS', 'toxicity', '3-year overall survival', 'EFS', 'event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",422.0,0.189385,"The median number of non-fatal toxicities per patient was higher in the experimental group while the median number of toxicities per chemotherapy course was not different. ","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Berthold', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany. Electronic address: frank.berthold@uk-koeln.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Faldum', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ernst', 'Affiliation': 'Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Cologne, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boos', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Muenster, Muenster, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dilloo', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eggert', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Charité Universitätsmedizin Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Experimental Pediatric Oncology and Center for Molecular Medicine, Medical Faculty, University of Cologne, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frühwald', 'Affiliation': ""Swabian Children's Cancer Center, Children's Hospital, University Hospital Augsburg, Augsburg, Germany.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Henze', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Klingebiel', 'Affiliation': 'Department of Children and Adolescents, University Hospital, Goethe University Frankfurt (Main), Frankfurt am Main, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kratz', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Medicinal University, Hannover, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kremens', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Essen, Essen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Krug', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Leuschner', 'Affiliation': ""Children's Tumor Registry, Institute of Pathology, University of Kiel, Kiel, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schumacher-Kuckelkorn', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'von Schweinitz', 'Affiliation': 'Department of Pediatric Surgery, University of Munich, Munich, Germany.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Schilling', 'Affiliation': 'Department of Pediatric Oncology and Hematology, Olgahospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Theissen', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Volland', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hero', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.11.011'] 1632,18840867,"What errors do peer reviewers detect, and does training improve their ability to detect them?","OBJECTIVE To analyse data from a trial and report the frequencies with which major and minor errors are detected at a general medical journal, the types of errors missed and the impact of training on error detection. DESIGN 607 peer reviewers at the BMJ were randomized to two intervention groups receiving different types of training (face-to-face training or a self-taught package) and a control group. Each reviewer was sent the same three test papers over the study period, each of which had nine major and five minor methodological errors inserted. SETTING BMJ peer reviewers. MAIN OUTCOME MEASURES The quality of review, assessed using a validated instrument, and the number and type of errors detected before and after training. RESULTS The number of major errors detected varied over the three papers. The interventions had small effects. At baseline (Paper 1) reviewers found an average of 2.58 of the nine major errors, with no notable difference between the groups. The mean number of errors reported was similar for the second and third papers, 2.71 and 3.0, respectively. Biased randomization was the error detected most frequently in all three papers, with over 60% of reviewers rejecting the papers identifying this error. Reviewers who did not reject the papers found fewer errors and the proportion finding biased randomization was less than 40% for each paper. CONCLUSIONS Editors should not assume that reviewers will detect most major errors, particularly those concerned with the context of study. Short training packages have only a slight impact on improving error detection.",2008,"Biased randomization was the error detected most frequently in all three papers, with over 60% of reviewers rejecting the papers identifying this error.",['607 peer reviewers at the BMJ'],['intervention groups receiving different types of training (face-to-face training or a self-taught package) and a control group'],"['number of major errors', 'error detection', 'mean number of errors']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0318162,"Biased randomization was the error detected most frequently in all three papers, with over 60% of reviewers rejecting the papers identifying this error.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ BMA House, Tavistock Square, London, UK. sschroter@bmj.com'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Godlee', 'Affiliation': ''}, {'ForeName': 'Lyda', 'Initials': 'L', 'LastName': 'Osorio', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,['10.1258/jrsm.2008.080062'] 1633,32432339,Time course of 75%-100% efficacy response of adjunctive brivaracetam.,"BACKGROUND Time to sustained seizure frequency reduction can provide clinically meaningful epilepsy outcomes. AIMS OF THE STUDY To examine the time course of brivaracetam (BRV) efficacy in adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS). METHODS Post hoc analysis of data pooled from three randomized controlled trials of oral adjunctive BRV in adults with epilepsy. Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or placebo for 12 weeks were analyzed for time to sustained ≥75%, ≥90%, and 100% seizure reduction without interruption from first day until trial ends. RESULTS Evaluation included 1160 patients with focal seizures, including 352 patients with FBTCS. Sustained ≥75%, ≥90%, and 100% response in focal seizures was higher from day 1 for BRV 100 and 200 mg/d vs placebo (P < .01). Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P < .01). CONCLUSIONS The majority of patients achieving 75%-100% sustained seizure frequency reduction (all focal seizure types and the subpopulation with FBTCS) with oral BRV (100 or 200 mg/d) achieved this response on the first-treatment day.",2020,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01). ","['1160 patients with focal seizures, including 352 patients with FBTCS', 'Patients with focal epilepsy and a subpopulation with FBTCS receiving BRV 50, 100, or 200 mg/d (initiated without up-titration) or', 'adults with focal seizures and focal to bilateral tonic-clonic seizures (FBTCS', 'adults with epilepsy']","['oral adjunctive BRV', 'adjunctive brivaracetam', 'oral BRV', 'placebo']","['focal seizures', 'time course of brivaracetam (BRV) efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1160.0,0.262434,"Sustained ≥75% and 100% FBTCS reduction from day 1 was higher for BRV 100 and 200-mg/d groups vs placebo (P <.01). ","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA.'}]",Acta neurologica Scandinavica,['10.1111/ane.13287'] 1634,31366435,Strategies for Improving Influenza Vaccination Rates in Patients with Chronic Renal Disease.,"BACKGROUND The influenza vaccination rate among older and chronically ill patients in Germany has declined in the past decade in spite of vaccination campaigns. METHODS The influenza vaccination rate among persons with chronic renal disease was studied with the aid of billing data from various Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen, ASHIPs) in Germany. It was tested in a randomized controlled trial whether a written vaccination appeal, sent by physicians to patients, led to an increase in the vaccination rate. It was tested in a further such trial whether the vaccination rate among patients with renal disease could be improved by an appeal for vaccination that was sent by the ASHIPs to the treating nephrologists. Finally, it was also tested in a prospective interventional study whether the vaccination rate could be improved by an appeal for vaccination sent by a health- insurance carrier directly to the patients. RESULTS In 2012-2017, the vaccination rate among persons with chronically impaired renal function ranged from 41.1% to 46.9%; it ranged from 31.7% to 33.7% in kidney transplant recipients and from 42.7% to 44.7% in dialysis patients. An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13). On the other hand, an appeal for vaccination that was sent to the nephrologists lowered the vaccination rate by 0.8% in the intervention group compared to the control group. Finally, an appeal for vaccination that was sent by the health-insurance fund to the patients raised the vaccination rate by 3.2% (p<0.001; NNT: 32). CONCLUSION Fewer than half of all patients with chronic renal failure in Germany are vaccinated against influenza. The vaccination rate was found to be increased only after an appeal for vaccination that was sent directly to the patients. A letter sent to the treating physicians had no positive effect at all.",2019,An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13).,"['patients with renal disease', 'Patients with Chronic Renal Disease', 'older and chronically ill patients in Germany', 'persons with chronic renal disease was studied with the aid of billing data from various Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen, ASHIPs) in Germany']",[],"['Influenza Vaccination Rates', 'influenza vaccination rate', 'renal function', 'vaccination rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.022799,An appeal for vaccination that was sent from physicians to patients raised the vaccination rate by 8.3% in the intervention group compared to the control group (p = 0.03; number needed to treat [NNT]: 13).,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Schulte', 'Affiliation': 'Department of Nephrology and Hypertension. University Hospital Schleswig-Holstein; Department of Strategic Data Analysis and Health Policy North Rhine-Westphalia, North Rhine Association of Statutory Health Insurance Physicians, Düsseldorf; IKK Südwest, Saarbrücken; Medical Department, Division of Infectiology and Pneumology, Faculty of Medicine, Charite Berlin; Center for Renal, Hypertensive, and Metabolic Diseases, Hanover; Institute of Medical Informatics and Statistics, University of Kie; Division of Information Technology-Analysis and Development, Schleswig-Holstein Association of Statutory Health Insurance Physicians, Bad Segeberg; Thuringia Association of Statutory Health Insurance Physicians, Weimar.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schierke', 'Affiliation': ''}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Tamayo', 'Affiliation': ''}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Hager', 'Affiliation': ''}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Engehausen', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Raspe', 'Affiliation': ''}, {'ForeName': 'Ralf-Harto', 'Initials': 'RH', 'LastName': 'Hübner', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schlieper', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Borzikowsky', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Urbschat', 'Affiliation': ''}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Auerswald', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Kunzendorf', 'Affiliation': ''}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Feldkamp', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0413'] 1635,19072894,Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study.,"The aim of the study was to investigate, with an rTMS/PET protocol, the after-effects induced by 1-Hz repetitive transcranial magnetic stimulation (rTMS) in the regional cerebral blood flow (rCBF) of the primary motor cortex (M1) contralateral to that stimulated during a movement. Eighteen healthy subjects underwent a baseline PET scan followed, in randomized order, by a session of Real/Sham low-frequency (1 Hz) subthreshold rTMS over the right M1 for 23 min. The site of stimulation was fMRI-guided. After each rTMS session (real or sham), subjects underwent behavioral hand motor tests and four PET scans. During the first two scans, ten subjects (RH group) moved the right hand ipsilateral to the stimulated site and eight subjects (LH group) moved the left contralateral hand. All remained still during the last two scans (rest). Two stroke patients underwent the same protocol with rTMS applied on contralesional M1. Compared with Sham-rTMS, Real-rTMS over the right M1 was followed by a significant increase of rCBF during right hand movement in left S1M1, without any significant change in motor performance. The effect lasted less than 1 h. The same rTMS-induced S1M1 overactivation was observed in the two stroke patients. Commissural connectivity between right dorsal premotor cortex and left M1 after real-rTMS was observed with a psychophysiological interaction analysis in healthy subjects. No major changes were found for the left hand. These results give further arguments in favor of a plastic commissural connectivity between M1 both in healthy subjects and in stroke patients, and reinforce the potential for therapeutic benefit of low-frequency rTMS in stroke rehabilitation.",2009,"Compared with Sham-rTMS, Real-rTMS over the right M1 was followed by a significant increase of rCBF during right hand movement in left S1M1, without any significant change in motor performance.","['healthy subjects', 'healthy subjects and acute stroke patients', 'Two stroke patients', 'Eighteen healthy subjects']","['baseline PET scan', 'rTMS', 'Neural substrates of low-frequency repetitive transcranial magnetic stimulation', '1-Hz repetitive transcranial magnetic stimulation (rTMS']","['motor performance', 'regional cerebral blood flow (rCBF', 'S1M1 overactivation', 'rCBF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",18.0,0.0190199,"Compared with Sham-rTMS, Real-rTMS over the right M1 was followed by a significant increase of rCBF during right hand movement in left S1M1, without any significant change in motor performance.","[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Conchou', 'Affiliation': 'INSERM U 825 Toulouse, F-31059 France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Loubinoux', 'Affiliation': ''}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Castel-Lacanal', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Tinnier', 'Affiliation': ''}, {'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Gerdelat-Mas', 'Affiliation': ''}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Faure-Marie', 'Affiliation': ''}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Gros', 'Affiliation': ''}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Thalamas', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Calvas', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chollet', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simonetta Moreau', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20690'] 1636,31397289,"Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial.","BACKGROUND Inclusion body myositis is an idiopathic inflammatory myopathy and the most common myopathy affecting people older than 50 years. To date, there are no effective drug treatments. We aimed to assess the safety, efficacy, and tolerability of bimagrumab-a fully human monoclonal antibody-in individuals with inclusion body myositis. METHODS We did a multicentre, double-blind, placebo-controlled study (RESILIENT) at 38 academic clinical sites in Australia, Europe, Japan, and the USA. Individuals (aged 36-85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis. We randomly assigned participants (1:1:1:1) using a blocked randomisation schedule (block size of four) to either bimagrumab (10 mg/kg, 3 mg/kg, or 1 mg/kg) or placebo matched in appearance to bimagrumab, administered as intravenous infusions every 4 weeks for at least 48 weeks. All study participants, the funder, investigators, site personnel, and people doing assessments were masked to treatment assignment. The primary outcome measure was 6-min walking distance (6MWD), which was assessed at week 52 in the primary analysis population and analysed by intention-to-treat principles. We used a multivariate normal repeated measures model to analyse data for 6MWD. Safety was assessed by recording adverse events and by electrocardiography, echocardiography, haematological testing, urinalysis, and blood chemistry. This trial is registered with ClinicalTrials.gov, number NCT01925209; this report represents the final analysis. FINDINGS Between Sept 26, 2013, and Jan 6, 2016, 251 participants were enrolled to the study, of whom 63 were assigned to each bimagrumab group and 62 were allocated to the placebo group. At week 52, 6MWD change from baseline did not differ between any bimagrumab dose and placebo (least squares mean treatment difference for bimagrumab 10 mg/kg group, 17·6 m, SE 14·3, 99% CI -19·6 to 54·8; p=0·22; for 3 mg/kg group, 18·6 m, 14·2, -18·2 to 55·4; p=0·19; and for 1 mg/kg group, -1·3 m, 14·1, -38·0 to 35·4; p=0·93). 63 (100%) participants in each bimagrumab group and 61 (98%) of 62 in the placebo group had at least one adverse event. Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group). The most frequently reported adverse events with bimagrumab were muscle spasms (32 [51%] in the bimagrumab 10 mg/kg group, 43 [68%] in the 3 mg/kg group, 25 [40%] in the 1 mg/kg group, and 13 [21%] in the placebo group) and diarrhoea (33 [52%], 28 [44%], 20 [32%], and 11 [18%], respectively). Adverse events leading to discontinuation were reported in four (6%) participants in each bimagrumab group compared with one (2%) participant in the placebo group. At least one serious adverse event was reported by 21 (33%) participants in the 10 mg/kg group, 11 (17%) in the 3 mg/kg group, 20 (32%) in the 1 mg/kg group, and 20 (32%) in the placebo group. No significant adverse cardiac effects were recorded on electrocardiography or echocardiography. Two deaths were reported during the study, one attributable to subendocardial myocardial infarction (secondary to gastrointestinal bleeding after an intentional overdose of concomitant sedatives and antidepressants) and one attributable to lung adenocarcinoma. Neither death was considered by the investigator to be related to bimagrumab. INTERPRETATION Bimagrumab showed a good safety profile, relative to placebo, in individuals with inclusion body myositis but did not improve 6MWD. The strengths of our study are that, to the best of our knowledge, it is the largest randomised controlled trial done in people with inclusion body myositis, and it provides important natural history data over 12 months. FUNDING Novartis Pharma.",2019,"Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group).","['Individuals (aged 36-85 years) were eligible for the study if they met modified 2010 Medical Research Council criteria for inclusion body myositis', 'people older than 50 years', ' at 38 academic clinical sites in Australia, Europe, Japan, and the USA', 'Between Sept 26, 2013, and Jan 6, 2016, 251 participants were enrolled to the study, of whom 63 were assigned to each bimagrumab group and 62 were allocated to the', 'individuals with inclusion body myositis']","['intravenous bimagrumab', 'placebo', 'bimagrumab-a fully human monoclonal antibody', 'bimagrumab']","['diarrhoea', 'adverse cardiac effects', 'adverse events and by electrocardiography, echocardiography, haematological testing, urinalysis, and blood chemistry', 'Safety and efficacy', 'serious adverse event', 'subendocardial myocardial infarction', '6MWD', 'safety, efficacy, and tolerability', 'adverse event', 'muscle spasms', '6-min walking distance (6MWD']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0238190', 'cui_str': 'Myositis, Inclusion Body'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0262568', 'cui_str': 'Subendocardial myocardial infarction'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",251.0,0.673075,"Falls were the most frequent adverse event (48 [76%] in the bimagrumab 10 mg/kg group, 55 [87%] in the 3 mg/kg group, 54 [86%] in the 1 mg/kg group, and 52 [84%] in the placebo group).","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hanna', 'Affiliation': 'Medical Research Council (MRC) Centre for Neuromuscular Diseases, University College London (UCL) Institute of Neurology, London, UK. Electronic address: m.hanna@ucl.ac.uk.'}, {'ForeName': 'Umesh A', 'Initials': 'UA', 'LastName': 'Badrising', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Benveniste', 'Affiliation': 'Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lloyd', 'Affiliation': 'Department of Neuroscience, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Merrilee', 'Initials': 'M', 'LastName': 'Needham', 'Affiliation': 'Fiona Stanley Hospital, Institute for Immunology & Infectious Diseases Murdoch University and Notre Dame University, Perth, WA, Australia.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Chinoy', 'Affiliation': 'National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurology, Tohoku University School of Medicine, Sendai, Japan.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Machado', 'Affiliation': 'Medical Research Council (MRC) Centre for Neuromuscular Diseases, University College London (UCL) Institute of Neurology, London, UK; Centre for Rheumatology, Division of Medicine, UCL, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Reardon', 'Affiliation': 'Calvary Health Care Bethlehem, Caulfield South, VIC, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Visser', 'Affiliation': 'Department of Neurology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Ascherman', 'Affiliation': 'Department of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'James A L', 'Initials': 'JAL', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'UC Davis School of Medicine, Neuromuscular Research Center, Sacramento, CA, USA.'}, {'ForeName': 'Nanette C', 'Initials': 'NC', 'LastName': 'Joyce', 'Affiliation': 'UC Davis School of Medicine, Neuromuscular Research Center, Sacramento, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Bergh', 'Affiliation': 'Department of Neurology, University Hospital Saint-Luc, University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Baets', 'Affiliation': 'Neuromuscular Reference Centre, Department of Neurology, Antwerp University Hospital, and the Institute Born-Bunge, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jan L', 'Initials': 'JL', 'LastName': 'De Bleecker', 'Affiliation': 'Department of Neurology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Neuromuscular Diagnostic Center and Electromyography Laboratory, Boston, MA, USA.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mirabella', 'Affiliation': 'Department of Neurology, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Universitá Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Sharon P', 'Initials': 'SP', 'LastName': 'Nations', 'Affiliation': 'Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pegoraro', 'Affiliation': 'Department of Neurosciences, University of Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Maggi', 'Affiliation': 'Neuroimmunology and Neuromuscular Diseases Unit, Foundation IRCCS Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rodolico', 'Affiliation': 'Unit of Neurology and Neuromuscular Disorders, Azienda Ospedaliera Universitaria Policlinico G Martino, University of Messina, Messina, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Filosto', 'Affiliation': 'Center for Neuromuscular Diseases, Unit of Neurology, Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Center of Texas, Houston, TX, USA.'}, {'ForeName': 'Kumaraswamy', 'Initials': 'K', 'LastName': 'Sivakumar', 'Affiliation': 'Neuromuscular Research Center, Phoenix, AZ, USA.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California Irvine, Amyotrophic Lateral Sclerosis & Neuromuscular Center, Orange, CA, USA.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Mori-Yoshimura', 'Affiliation': 'Department of Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Neurology, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Katsuno', 'Affiliation': 'Department of Neurology, Nagoya University Hospital, Aichi, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nodera', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Ichizo', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Department of Neuromuscular Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Romano', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'Valerie S L', 'Initials': 'VSL', 'LastName': 'Williams', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lixin Zhang', 'Initials': 'LZ', 'LastName': 'Auberson', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Vera', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Dimitris A', 'Initials': 'DA', 'LastName': 'Papanicolaou', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30200-5'] 1637,31654434,In response to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['propofol', 'Dexmedetomidine']",[],[],"[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0283193,,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tonsy', 'Initials': 'T', 'LastName': 'Pandiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Otolaryngology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.28363'] 1638,31802697,Does the Healthy Body Image program improve lifestyle habits among high school students? A randomized controlled trial with 12-month follow-up.,"OBJECTIVES Positive embodiment and healthy lifestyle habits seem to be related; therefore, stimulating positive embodiment should promote healthy lifestyle habits. In the current study, we delivered the Healthy Body Image (HBI) intervention among Norwegian high school students and examined the effects on healthy lifestyle habits. METHODS The HBI intervention comprises three interactive workshops, with three overarching themes related to body image, social media literacy, and lifestyle. A total of 2446 boys (43%) and girls in grade 12 (mean age 16.8 years) from 30 high schools participated in this cluster-randomized controlled study. Schools were randomized to the HBI intervention or control study arm. Data on physical activity, eating habits, and sleep were collected at baseline, post intervention, and 3- and 12-month follow-up and analyzed using linear mixed regression models. RESULTS The intervention had a minor negative effect on physical activity levels in boys at 12-month follow-up and short-term small-to-moderate positive effects on consumption of breakfast and fruit and vegetables, and sleep duration on school days. CONCLUSIONS In future, the lack of satisfactorily long-term effects might be better addressed using a combination of cognitive and behavioral approaches to more optimally integrate positive embodiment and lifestyle changes in the daily life of adolescents. Trial registration: ClinicalTrials.gov ID: PRSNCT02901457. Approved by the Regional Committee for Medical and Health Research Ethics.",2019,,[],[],['lifestyle habits'],[],[],"[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.0322057,,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, Tromsø, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Monica K', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Kristiansand, Norway.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Engen', 'Affiliation': 'The Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, Tromsø, Norway.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT - The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, Tromsø, Norway.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, Kongsberg, Norway.'}]",The Journal of international medical research,['10.1177/0300060519889453'] 1639,32432384,Internet-based interpretation bias modification for body dissatisfaction: A three-armed randomized controlled trial.,"OBJECTIVE Appearance-related interpretation bias is postulated to play a role in the maintenance of body dissatisfaction (BD), a risk factor for body dysmorphic disorder (BDD), and eating disorders (ED). Cognitive bias modification for interpretation (CBM-I) has been shown to reduce maladaptive interpretation bias and symptoms in various emotional disorders. This study investigated the acceptability and efficacy of an easily disseminable, web-based CBM-I program for BD. METHODS Individuals with high BD (N = 318) were randomized to a multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition. Interpretation bias, BD and associated symptoms were assessed at baseline and post-intervention. Symptoms were monitored up to 1-week and 4-week follow-up. We further investigated transference effects to stress reactivity, as predicted by cognitive-behavioral models, at post-intervention. RESULTS Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18). Both CBM-I and control training reduced BD, BDD symptom severity, and depression. However, CBM-I (vs. control and waitlist) improved appearance-related quality of life (d = 0.51), self-esteem (d = 0.52), and maladaptive appearance-related beliefs (d = 0.47). State stress reactivity was overall reduced in the CBM-I condition (vs. waitlist). Intervention effects largely held stable up to follow-ups. Treatment satisfaction was comparable to other CBM-I studies, with low rates of adverse reactions. DISCUSSION These findings support assumptions of cognitive-behavioral models for BD, BDD, and ED, and suggest that web-based CBM-I is an efficacious and acceptable intervention option.",2020,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).",['Individuals with high BD (N = 318'],"['multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition', 'Internet-based interpretation bias modification']","['BD, BDD symptom severity, and depression', 'State stress reactivity', 'Treatment satisfaction', 'maladaptive appearance-related beliefs', 'self-esteem', 'acceptability and efficacy', 'appearance-related quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",318.0,0.0516419,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).","[{'ForeName': 'Fanny Alexandra', 'Initials': 'FA', 'LastName': 'Dietel', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Zache', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Paul-Christian', 'Initials': 'PC', 'LastName': 'Bürkner', 'Affiliation': 'Department of Computer Science, Aalto University, Espoo, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schulte', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bischof', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Buhlmann', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23280'] 1640,18580613,Early virological suppression with three-class antiretroviral therapy in HIV-infected African infants.,"OBJECTIVES Infants infected with HIV-1 perinatally despite single-dose nevirapine progress rapidly. Data on treatment outcome in sub-Saharan African infants exposed to single-dose nevirapine are urgently required. This feasibility study addresses efficacy of infant antiretroviral therapy in this setting. METHODS HIV-infected infants in Durban, South Africa, received randomized immediate or deferred (when CD4 cell count reached <20%) four-drug antiretroviral therapy (zidovudine/lamivudine/nelfinavir/nevirapine). Genotyping for non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance was undertaken pre-antiretroviral therapy. Monthly follow-up to 1-year post-antiretroviral therapy included viral load, CD4 cell count and verbal/measured adherence monitoring. RESULTS All 63 infants were exposed to single-dose nevirapine. Twenty-one out of 51 (39%) infants with baseline genotyping results had NNRTI resistance (most frequently Y181C; 20%). Forty-three infants were randomized to immediate antiretroviral therapy (ART): three withdrew pre-antiretroviral therapy; 36 out of 40 completed 1-year of ART. Twenty infants received deferred ART: 17 reached CD4 cell counts less than 20% (median d99) and 13 out of 17 started antiretroviral therapy in year 1. Verbal and measured adherence was 99% and 95%, respectively. One-year post-ART, 49 out of 49 (100%) infants had a viral load less than 400 copies/ml; 46 out of 49 (94%) had viral load less than 50 copies/ml. Ten infants (20%) required second-line ART due to virological failure or tuberculosis treatment, therefore 39 out of 49 (80%) achieved viral load less than 400 copies/ml by intention-to-treat. Time to viral load less than 50 copies/ml correlated with maternal CD4 cell count (r = -0.42; P = 0.005) and infant pre-ART viral load (r = 0.64; P < 0.001). NNRTI mutations had no significant effect on virological suppression. Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression. CONCLUSION Excellent adherence and virological suppression are achievable in infants, despite high-frequency NNRTI mutations and rapid disease progression. Infants remain relatively neglected in roll-out programmes and ART provision must be expanded.",2008,"Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression. ","['Forty-three infants', 'Twenty infants received', 'Infants infected with HIV-1 perinatally despite single-dose', 'HIV-infected African infants', 'sub-Saharan African infants', 'HIV-infected infants in Durban, South Africa']","['nevirapine', 'antiretroviral therapy (zidovudine/lamivudine/nelfinavir/nevirapine', 'deferred ART', 'immediate antiretroviral therapy (ART): three withdrew pre-antiretroviral therapy']","['CD4 cell counts', 'viral load less', 'virological suppression', 'maternal CD4 cell count', 'viral load, CD4 cell count and verbal/measured adherence monitoring', 'Verbal and measured adherence', 'NNRTI resistance', 'illness episodes', 'Excellent adherence and virological suppression']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0525005', 'cui_str': 'Nelfinavir'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}]",43.0,0.518457,"Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression. ","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK. andy.prendergast@gmail.com'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mphatswe', 'Affiliation': ''}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Tudor-Williams', 'Affiliation': ''}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Rakgotho', 'Affiliation': ''}, {'ForeName': 'Visva', 'Initials': 'V', 'LastName': 'Pillay', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Thobakgale', 'Affiliation': ''}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'McCarthy', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Goulder', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0b013e32830437df'] 1641,31988029,Effect of an upstream grid on the fluidization of pharmaceutical carrier powders.,"The influence of grid generated mixing on the fluidization of pharmaceutical carrier powders is studied in a channel-flow experiment using direct high-speed imaging and particle image velocimetry (PIV). Four different lactose powders with mass median diameters that range between 61 µm and 121 µm are used. The degree of powder mixing in the flow as a function of grid position relative to the powder bed and grid area blockage ratios (ranging from ~25% to ~40%) is studied for a range of flow-rates. The study presents comprehensive mappings of how pharmaceutical powders are fluidised under the influence of mixing, by examining powder bed morphology, powder emptying rate, and the local flow-field surrounding the pocket. The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology. Use of a grid can enable evacuation of powder at lower overall flow-rates, which may have important implications on respiratory drug delivery. PIV results show the trend of mean velocities with the mass median powder diameter and demonstrates how a grid with lower blockage ratio can increase the degree of mixing of the evacuating powder and make the evacuation process more rapid. This study contributes towards a better understanding of fluidization processes as relevant to dry powder inhaler devices and sheds light on how simple design alterations, such as adding an upstream grid, can be incorporated to optimise device effectiveness.",2020,The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology.,[],[],[],[],[],[],,0.0304694,The use of a grid results in higher evacuation percentages (void fraction) and a faster evacuation rate but is associated with randomized evacuation behaviour as observed from the powder bed morphology.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Elserfy', 'Affiliation': 'School of Engineering, Macquarie University, NSW 2109, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kourmatzis', 'Affiliation': 'School of Aerospace, Mechanical and Mechatronic Engineering, The University of Sydney, NSW 2006, Australia. Electronic address: agisilaos.kourmatzis@sydney.edu.au.'}, {'ForeName': 'H-K', 'Initials': 'HK', 'LastName': 'Chan', 'Affiliation': 'Advanced Drug Delivery Group, School of Pharmacy, The University of Sydney, NSW 2006, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Walenga', 'Affiliation': 'Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'School of Engineering, Macquarie University, NSW 2109, Australia.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119079'] 1642,32427638,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 1.,,2020,,[],[],[],[],[],[],,0.0179934,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'From the Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, New York, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000316'] 1643,31522082,Effects of timing of acute catechin-rich green tea ingestion on postprandial glucose metabolism in healthy men.,"Green tea polyphenols, particularly catechins, decrease fasting and postprandial glucose. However, no studies have compared the timing of green tea ingestion on glucose metabolism and changes in catechin concentrations. Here, we examined the effects of timing of acute catechin-rich green tea ingestion on postprandial glucose metabolism in young men. Seventeen healthy young men completed four trials involving blood collection in a fasting state and at 30, 60, 120, and 180 min after meal consumption in a random order: 1) morning placebo trial (09:00 h; MP trial), 2) evening placebo trial (17:00 h; EP trial), 3) morning catechin-rich green tea trial (09:00 h; MGT trial), and 4) evening catechin-rich green tea trial (17:00 h; EGT trial). The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials. Additionally, the concentration of glucose was significantly lower in EGT trials than in the EP trials at 60 min (P=.014). Moreover, the concentrations of glucose-dependent insulinotropic polypeptide were significantly lower in the green tea trials than in the placebo trials at 30 min (morning: P=.010, evening: P=.006) and 60 min (morning: P=.001, evening: P=.006) after meal intake in both the morning and evening trials. Our study demonstrated that acute ingestion of catechin-rich green tea in the evening reduced postprandial plasma glucose concentrations.",2019,The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials.,"['young men', 'healthy men', 'Seventeen healthy young men']","['placebo', 'acute catechin-rich green tea ingestion', 'catechin-rich green tea']","['postprandial plasma glucose concentrations', 'concentration of glucose', 'glucose metabolism and changes in catechin concentrations', 'concentrations of glucose', 'fasting and postprandial glucose', 'postprandial glucose metabolism', 'concentrations of glucose-dependent insulinotropic polypeptide']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1384640', 'cui_str': 'Green Tea'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}]",17.0,0.268856,The concentrations of glucose at 120 min (P=.031) and 180 min (P=.013) after meal intake were significantly higher in the MGT trials than in the MP trials.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Waseda Bioscience Research Institute in Singapore, Waseda University, 11 Biopolis Way, Singapore 138667, Singapore. Electronic address: m-takahashi@aoni.waseda.jp.'}, {'ForeName': 'Mamiho', 'Initials': 'M', 'LastName': 'Ozaki', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Miyashita', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, 2-579-15 Mikajima Tokorozawa, Saitama 3591192, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Fukazawa', 'Affiliation': 'Graduate School of Advanced Science and Engineering, Waseda University, 2-2 Wakamatsu-cho Shinjuku, Tokyo 1628480, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakaoka', 'Affiliation': ""Department of Medicine, Tokyo Women's Medical University, Medical Center East, 2-1-10 Nishiogu Arakawa, Tokyo 1168567, Japan.""}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Wakisaka', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Masanobu', 'Initials': 'M', 'LastName': 'Hibi', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Osaki', 'Affiliation': 'R&D, Core Technology, Biological Science Research, Kao Corporation, 2-1-3 Bunka Sumida, Tokyo 1318501, Japan.'}, {'ForeName': 'Shigenobu', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjuku, Tokyo 1628480, Japan.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.108221'] 1644,31937362,Long-term effects of a cluster randomized controlled kindergarten-based intervention trial on vegetable intake among Norwegian 3-5-year-olds: the BRA-study.,"OBJECTIVE To report on long-term effects of a cluster randomized controlled kindergarten-based intervention trial, which aimed to increase vegetable intake among Norwegian preschool children (3-5 years at baseline). The effects of the intervention at follow-up 1 (immediately post-intervention) have previously been published. This paper presents the effects of the intervention from baseline to follow-up 2 (12 months post-intervention). RESULTS Parental consents were obtained for 633 out of 1631 eligible children (response rate 38.8%). The effects of the intervention from baseline to follow-up 2 were assessed by mixed-model analyses taking the clustering effect of kindergartens into account. Children's vegetable intake was reported by the parents at baseline (spring 2015), at follow-up 1 (spring 2016) and at follow-up 2 (spring 2017). No significant long-term effects in child vegetable intake were found. A mean difference of - 0.1 times per day (95% CI - 0.5, 0.2) (P = 0.44) was found for the daily frequency of vegetable intake. A mean difference of - 0.2 different kinds of vegetables eaten over a month (95% CI - 1.0, 0.7) (P = 0.70) was found and for daily amount of vegetables a mean difference of - 15.0 g vegetables (95% CI - 38.0, 8.0) (P = 0.19) was found. Trial registration International Standard Randomised Controlled Trials ISRCTN51962956 (http://www.isrctn.com/ISRCTN51962956). Registered 21 June 2016 (retrospectively registered).",2020,"RESULTS Parental consents were obtained for 633 out of 1631 eligible children (response rate 38.8%).","['Norwegian 3-5-year-olds', 'Registered 21 June 2016 (retrospectively registered', 'Norwegian preschool children (3-5\xa0years at baseline']",[],"[""Children's vegetable intake"", 'child vegetable intake', 'vegetable intake']","[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]",1631.0,0.202953,"RESULTS Parental consents were obtained for 633 out of 1631 eligible children (response rate 38.8%).","[{'ForeName': 'Anne Lene', 'Initials': 'AL', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway. a.l.kristiansen@medisin.uio.no.'}, {'ForeName': 'Anine Christine', 'Initials': 'AC', 'LastName': 'Medin', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bjelland', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Himberg-Sundet', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lien', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Holst', 'Affiliation': 'Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, PO Box 1122, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Lene Frost', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}]",BMC research notes,['10.1186/s13104-020-4892-x'] 1645,31524498,"Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial.","BACKGROUND Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown. METHODS DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m 2 , and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP. RESULTS Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL (95% CI 1089-1304), P =0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal P =0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98-3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1-3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all P values for interaction=NS). CONCLUSIONS In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02653482.",2019,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"['≥30', 'patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown', 'Patients With Heart Failure', 'patients with type 2 diabetes mellitus', 'Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate', 'patients without type 2 diabetes mellitus', '263 patients']","['dapagliflozin 10 mg daily or placebo', 'dapagliflozin', 'placebo', 'HF (Dapagliflozin', 'Dapagliflozin', 'sodium-glucose co-transporter-2 inhibitors']","['elevated natriuretic peptides', 'NT-proBNP', 'mean NT-proBNP', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score', 'Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP', 'Biomarkers, Symptoms, and Functional Status', 'Ejection Fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3811844'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",263.0,0.228944,There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Nassif', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Windsor', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Fengming', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Khariton', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, Canada (M.H.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor (B.P.).'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Austin', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Drazner', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M., M.H.D.).'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles (M.W.F.).'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (B.M.S., M.M.G.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gordon', 'Affiliation': 'NorthShore University, Evanston, IL (R.A.G.).'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Jermyn', 'Affiliation': 'St. Francis Hospital, Roslyn, NY (R.J.).'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Katz', 'Affiliation': 'New York University Langone Health, New York (S.D.K.).'}, {'ForeName': 'Sumant', 'Initials': 'S', 'LastName': 'Lamba', 'Affiliation': 'First Coast Cardiovascular Institute, Jacksonville, FL (S.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Hospital, Detroit, MI (D.E.L.).'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'LaRue', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO (S.J.L.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University, Nashville, TN (J.L.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Malone', 'Affiliation': 'Charlotte Heart Group Research Center, Port Charlotte, FL (M.M.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Margulies', 'Affiliation': 'University of Pennsylvania, Philadelphia (K.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University, Durham, NC (R.J.M.).'}, {'ForeName': 'R Kannan', 'Initials': 'RK', 'LastName': 'Mutharasan', 'Affiliation': 'Northwestern University, Chicago, IL (R.K.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pursley', 'Affiliation': 'Heart Group of the Eastern Shore, Fairhope, AL (M.P.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University, Atlanta, GA (G.U.).'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (M.E.N., S.L.W., F.T., Y.K., B.A., M.K.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042929'] 1646,18095276,Functional neuroanatomy of CCK-4-induced panic attacks in healthy volunteers.,"Experimental panic induction with cholecystokinin tetrapeptide (CCK-4) is considered as a suitable model to investigate the pathophysiology of panic attacks. While only a few studies investigated the brain activation patterns following CCK-4, no data are available on the putative involvement of the amygdala in the CCK-4 elicited anxiety response. We studied the functional correlates of CCK-4-induced anxiety in healthy volunteers by means of functional magnetic resonance imaging (fMRI) and region of interest (ROI) analysis of the amygdala. Sixteen healthy volunteers underwent challenge with CCK-4 compared with placebo in a single-blind design. Functional brain activation patterns were determined for the CCK-4-challenge, the placebo response and anticipatory anxiety (AA). CCK-4-induced anxiety was accompanied by a strong and robust activation (random effects analysis, P < 0.00001, uncorrected for multiple testing) in the ventral anterior cingulate cortex (ACC), middle and superior frontal gyrus, precuneus, middle and superior temporal gyrus, occipital lobe, sublobar areas, cerebellum, and brainstem. In contrast, random effects group analysis for placebo and AA using the same level of significance generated no significant results. Using a more liberal level of significance, activations could be observed in some brain regions such as the dorsal part of the ACC during AA (random effects analysis, P < 0.005). Overall functional responses did not differ between panickers and nonpanickers. Only 5 of 11 subjects showed strong amygdala activation. However, ROI analysis pointed towards higher scores in fear items in these subjects. In conclusion, while overall brain activation patterns are not related to the subjective anxiety response to CCK-4, amygdala activation may be involved in the subjective perception of CCK-4-induced fear.",2009,"CCK-4-induced anxiety was accompanied by a strong and robust activation (random effects analysis, P < 0.00001, uncorrected for multiple testing) in the ventral anterior cingulate cortex (ACC), middle and superior frontal gyrus, precuneus, middle and superior temporal gyrus, occipital lobe, sublobar areas, cerebellum, and brainstem.","['Sixteen healthy volunteers', 'healthy volunteers']","['CCK-4', 'cholecystokinin tetrapeptide (CCK-4', 'placebo', 'functional magnetic resonance imaging (fMRI) and region of interest (ROI']","['ventral anterior cingulate cortex (ACC), middle and superior frontal gyrus, precuneus, middle and superior temporal gyrus, occipital lobe, sublobar areas, cerebellum, and brainstem', 'CCK-4-induced anxiety', 'Functional brain activation patterns', 'strong amygdala activation', 'Overall functional responses', 'placebo response and anticipatory anxiety (AA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039659', 'cui_str': 'Cholecystokinin-Tetrapeptide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0152309', 'cui_str': 'Gyrus Temporalis Superior'}, {'cui': 'C0028785', 'cui_str': 'Occipital Region'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006121', 'cui_str': 'Truncus Cerebri'}, {'cui': 'C0039659', 'cui_str': 'Cholecystokinin-Tetrapeptide'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}]",16.0,0.0265293,"CCK-4-induced anxiety was accompanied by a strong and robust activation (random effects analysis, P < 0.00001, uncorrected for multiple testing) in the ventral anterior cingulate cortex (ACC), middle and superior frontal gyrus, precuneus, middle and superior temporal gyrus, occipital lobe, sublobar areas, cerebellum, and brainstem.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Eser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany. daniela.eser@med.uni-muenchen.de'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leicht', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Lutz', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Wenninger', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Kirsch', 'Affiliation': ''}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Schüle', 'Affiliation': ''}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Karch', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Baghai', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pogarell', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Born', 'Affiliation': ''}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mulert', 'Affiliation': ''}]",Human brain mapping,[] 1647,18095278,"Late evening brain activation patterns and their relation to the internal biological time, melatonin, and homeostatic sleep debt.","Sleep propensity increases sharply at night. Some evidence implicates the pineal hormone melatonin in this process. Using functional magnetic resonance imaging, brain activation during a visual search task was examined at 22:00 h (when endogenous melatonin levels normally increase). The relationships between brain activation, endogenous melatonin (measured in saliva), and self-reported fatigue were assessed. Finally, the effects of exogenous melatonin administered at 22:00 h were studied in a double blind, placebo-controlled crossover manner. We show that brain activation patterns as well as the response to exogenous melatonin significantly differ at night from those seen in afternoon hours. Thus, activation in the rostro-medial and lateral aspects of the occipital cortex and the thalamus diminished at 22:00 h. Activation in the right parietal cortex increased at night and correlated with individual fatigue levels, whereas exogenous melatonin given at 22:00 h reduced activation in this area. The right dorsolateral prefrontal cortex, an area considered to reflect homeostatic sleep debt, demonstrated increased activation at 22:00 h. Surprisingly, this increase correlated with endogenous melatonin. These results demonstrate and partially differentiate circadian effects (whether mediated by melatonin or not) and homeostatic sleep debt modulation of human brain activity associated with everyday fatigue at night.",2009,"The right dorsolateral prefrontal cortex, an area considered to reflect homeostatic sleep debt, demonstrated increased activation at 22:00 h.",[],"['exogenous melatonin', 'placebo']","['internal biological time, melatonin, and homeostatic sleep debt', 'brain activation, endogenous melatonin (measured in saliva), and self-reported fatigue']",[],"[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0190484,"The right dorsolateral prefrontal cortex, an area considered to reflect homeostatic sleep debt, demonstrated increased activation at 22:00 h.","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Gorfine', 'Affiliation': 'Department of Neurobiochemistry, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Zisapel', 'Affiliation': ''}]",Human brain mapping,[] 1648,31982647,A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol.,"INTRODUCTION The transition from high school to college is a developmentally sensitive period that is high-risk for the escalation of alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. College alcohol interventions target drinking directly at a time when students may be uninterested in changing their drinking. Approaches that indirectly target drinking may be particularly effective. Behavioral activation (BA) is an intervention that indirectly addresses mental health conditions by guiding individuals to engage in reinforcing activities that align with their values (Lejuez et al., 2001). A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011). METHODS The cluster-randomized trial will test the efficacy of BA administered in a semester-long (16 week) freshman orientation course, compared to a standard orientation course in 540 freshmen spread over 36 course sections (18 sections each). A 5-month post-treatment assessment will measure durability of effects. DISCUSSION The study will test a promising BA intervention that addresses factors limiting participation in other programs by targeting alcohol use indirectly and by integrating an intervention into college curriculum. This study represents a first step toward developing an intervention course that could be widely disseminated to address the persistent college drinking problem and its consequences. CLINICAL TRIALS REGISTRATION NUMBER NCT04038190.",2020,"A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011). ",[],"['BA', 'Behavioral activation (BA', 'BA intervention', 'behavioral activation intervention']",['drinking-related problems'],[],[],"[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0191295,"A pilot study of a BA intervention administered in a semester-long freshman orientation course reported a significant decrease in drinking-related problems compared to students in standard orientation course (Reynolds et al., 2011). ","[{'ForeName': 'Tera L', 'Initials': 'TL', 'LastName': 'Fazzino', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America. Electronic address: tfazzino@ku.edu.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, United States of America; Department of Psychology, University of Kansas, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105950'] 1649,31522924,A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial.,"BACKGROUND Respiratory exacerbations impair lung function and health-related quality of life in people with CF, with delayed identification of exacerbations often resulting in worse outcomes. We developed a smartphone application (app) for adults with CF to report symptoms to the CF team, and investigated its impact on antibiotic use and other outcomes. METHODS Participants were randomised to intervention (use of the app weekly or sooner if symptoms had worsened) or control (usual care). The app comprised questions relating to symptoms suggestive of an exacerbation. If worsening symptoms were reported, the participant was contacted by the nurse practitioner. The primary outcome measure was the number of courses and days of intravenous (IV) antibiotics. RESULTS Sixty participants (29 female, aged [mean ± SD] 31 ± 9 years, FEV 1 60 ± 18% predicted) were recruited, with 29 (48%) allocated to the intervention group. Over the 12-month follow-up, there was no clear effect of the app on the number of courses of IV antibiotics (incidence rate ratio [IRR] 1; 95% confidence interval [CI] 0.6 to 1.7), however number of courses of oral antibiotics increased (IRR 1.5; 95% CI 1.0 to 2.2). The median [IQR] time to detection of exacerbation requiring oral or IV antibiotics was shorter in the intervention group compared with the control group (70 [123] vs. 141 [140] days; p = .02). No between-group differences were observed in other outcomes. CONCLUSION The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.",2020,"The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.","['Participants', 'adults with cystic fibrosis', 'Sixty participants (29 female, aged [mean\u202f±\u202fSD] 31\u202f±\u202f9\u202fyears, FEV 1 60\u202f±\u202f18% predicted) were recruited, with 29 (48%) allocated to the intervention group', 'people with CF', 'adults with CF to report symptoms to the CF team']","['smartphone application', 'app weekly or sooner if symptoms had worsened) or control (usual care']","['median [IQR] time to detection of exacerbation requiring oral or IV antibiotics', 'number of courses of IV antibiotics', 'detection of exacerbations', 'number of courses and days of intravenous (IV) antibiotics', 'number of courses of oral antibiotics']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]",60.0,0.412785,"The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Putrino', 'Affiliation': 'Abilities Research Center, Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Siobhain', 'Initials': 'S', 'LastName': 'Mulrennan', 'Affiliation': 'Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Morey', 'Affiliation': 'Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Clinical Research and Education, Child and Adolescent Health Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia. Electronic address: k.hill@curtin.edu.au.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.002'] 1650,31524116,A low-fat diet up-regulates expression of fatty acid taste receptor gene FFAR4 in fungiform papillae in humans: a co-twin randomised controlled trial.,"Fatty acid taste (FAT) perception is involved in the regulation of dietary fat intake, where impaired FAT is associated with increased fatty food intake. There are a number of FAT receptors identified on human taste cells that are potentially responsible for FAT perception. Manipulating dietary fat intake, and in turn FAT perception, would elucidate the receptors that are associated with long-term regulation of FAT perception. The present study aimed to assess associations between diet-mediated changes to FAT receptors and FAT perception in humans. A co-twin randomised controlled trial was conducted, where each matching twin within a pair were randomly allocated to either an 8-week low-fat (LF; <20 % energy fat) or an 8-week high-fat (HF; >35 % energy fat) diet. At baseline and week 8, fungiform papillae were biopsied in the fasted state and FAT receptor gene expressions (cluster of differentiation 36 (CD36), free fatty acid receptor 2 (FFAR2), FFAR4, G protein-coupled receptor 84 (GPR84) and a delayed rectifying K+ channel (K+ voltage-gated channel subfamily A member 2; KCNA2)) were measured using RT-PCR; and FAT threshold (FATT) was assessed using three-alternate forced choice methodology. Linear mixed models were fitted, adjusting for correlation between co-twins. Intake was compliant with the study design, with the LF and HF groups consuming 14·8 and 39·9 % energy from fat, respectively. Expression of FFAR4 increased by 38 % in the LF group (P = 0·023; time-diet interaction P = 0·063). ΔFFAR4 (Δ, week 8-baseline) was associated with Δfat intake (g) ( = -159·4; P < 0·001) and ΔFATT ( = -8·8; P = 0·016). In summary, FFAR4 is involved in long-term diet-mediated changes to FAT perception. Manipulating dietary fat intake, and therefore FFAR4 expression, might aid in reducing taste-mediated passive overconsumption of fatty foods.",2019,Expression of FFAR4 increased by 38% in the LF group (P=0.023; time-diet interaction P=0.063).,"['fungiform papillae in humans', 'humans']","['8-week low-fat (LF', 'Fatty acid taste (FAT) perception']",['Expression of FFAR4'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C2350521', 'cui_str': 'Gustatory Perception'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0304403,Expression of FFAR4 increased by 38% in the LF group (P=0.023; time-diet interaction P=0.063).,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Costanzo', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Dongli', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Nowson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Konsta', 'Initials': 'K', 'LastName': 'Duesing', 'Affiliation': 'Health & Biosecurity, Commonwealth Scientific and Industrial Research Organisation (CSIRO), North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Archer', 'Affiliation': 'Agriculture & Food, CSIRO, North Ryde, NSW 2113, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Bowe', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Keast', 'Affiliation': 'School of Exercise and Nutrition Sciences, Centre for Advanced Sensory Science, Deakin University, Geelong, VIC 3220, Australia.'}]",The British journal of nutrition,['10.1017/S0007114519002368'] 1651,31981566,Change in Clinical Practice Associated With a Large Randomized Controlled Trial Comparing RBC Transfusion Strategies.,,2020,,[],[],[],[],[],[],,0.109654,,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Trentino', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia; Data and Digital Innovation, East Metropolitan Health Service, Perth, Australia. Electronic address: kevin.trentino@uwa.edu.au.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Leahy', 'Affiliation': 'Department of Haematology, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Farmer', 'Affiliation': 'Medical School and Division of Surgery, University of Western Australia, Perth, Australia; School of Health Sciences and Graduate Studies, Curtin University, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilfillan', 'Affiliation': 'Department of Cardiothoracic Surgery, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",Chest,['10.1016/j.chest.2020.01.004'] 1652,32427667,Racial Differences in the Influence of Health Care System Factors on Informal Support for Cancer Care Among Black and White Breast and Lung Cancer Survivors.,"This retrospective, secondary qualitative analysis investigates whether health system factors influence social support among Black and white breast and lung cancer survivors and racial differences in support. These data come from race- and cancer-stratified focus groups (n = 6) and interviews (n = 2) to inform a randomized controlled trial utilizing antiracism and community-based participatory research approaches. Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted. Resources within individual support networks reflect broader sociostructural factors. Reliance on family/friends to fill gaps in cancer care may exacerbate racial disparities.",2020,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","['Cancer Care', 'Black and White Breast and Lung Cancer Survivors', 'Black and white breast and lung cancer survivors']",['health system factors influence social support'],[],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",[],6.0,0.0371642,"Findings indicate social support was helpful for overcoming treatment-related challenges, including symptom management and patient-provider communication; racial differences in support needs and provision were noted.","[{'ForeName': 'Katrina R', 'Initials': 'KR', 'LastName': 'Ellis', 'Affiliation': 'Greensboro Health Disparities Collaborative, North Carolina (Drs Ellis, Black, Baker, Davis, Doost, Lightfoot, Samuel, Schaal, and Eng and Mss Cothern, Goestch, Griesemer, Guerrab, Padilla, and Yongue); School of Social Work, University of Michigan, Ann Arbor (Dr Ellis); College of Health and Human Performance, East Carolina University, Greenville (Dr Black); Public Health Studies Program, Elon University, North Carolina (Dr Baker); School of Medicine, Washington University, St Louis, Missouri (Dr Davis); Departments of Health Behavior (Mss Griesemer and Guerrab and Drs Lightfoot and Eng) and Health Policy and Management (Ms Padilla and Dr Samuel), University of North Carolina, Chapel Hill; Center for Health Promotion and Disease Prevention, University of North Carolina (Dr Lightfoot); The Partnership Project, Inc, Greensboro, North Carolina (Dr Schaal); and Department of Public Health Education, University of North Carolina at Greensboro (Ms Yongue).'}, {'ForeName': 'Kristin Z', 'Initials': 'KZ', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cothern', 'Affiliation': ''}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Doost', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Goestch', 'Affiliation': ''}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': ''}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Guerrab', 'Affiliation': ''}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'Lightfoot', 'Affiliation': ''}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': ''}, {'ForeName': 'Cleo A', 'Initials': 'CA', 'LastName': 'Samuel', 'Affiliation': ''}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Schaal', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yongue', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Eng', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000264'] 1653,32434372,Efficacy of a Short-Term Low-Calorie Diet in Overweight and Obese Patients with Chronic Sciatica: A Randomized Controlled Trial.,"Objectives: Chronic sciatica is a common condition. According to Traditional Persian Medicine and recent studies, calorie reduction is thought to be helpful for this condition. The purpose of this work is to evaluate a short-term low-calorie diet (LCD) for ameliorating chronic sciatica in the context of pain relief and reduced disability for patients. Design: In this randomized controlled trial, 96 candidates for the nonsurgical treatment of chronic sciatica were randomly assigned to two groups to receive a 1-month LCD (intervention) or ordinary diet (control), both in combination with nonsteroidal anti-inflammatory drugs (NSAIDs). Afterward, patients were visited at baseline and on days 15, 30, and 60 after treatment. Pain and disability were evaluated using the short-form McGill pain questionnaire (SFMPQ) and the Roland-Morris disability questionnaire (RMDQ), respectively. Results: Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group. SFMPQ descriptor scale scores at baseline and on days 15, 30, and 60 in the LCD group were 7.71 ± 1.69, 6.63 ± 1.61, 5.54 ± 1.87, and 4.96 ± 2.02, respectively, and in the control group were 6.63 ± 1.44, 6.69 ± 1.32, 6.64 ± 1.98, and 6.62 ± 2.53, respectively ( p  = 0.001). RMDQ scores at baseline and on days 15, 30, and 60 in LCD group were 11.17 ± 3.90, 8.60 ± 1.97, 7.50 ± 2.71, and 6.77 ± 3.06, respectively, and in the control group, 10.00 ± 2.20, 9.98 ± 2.29, 9.94 ± 2.94, and 9.85 ± 3.32, respectively ( p  < 0.001). Conclusion: A short-term (1-month) LCD is effective in decreasing pain and disability in candidates for nonsurgical treatment of chronic sciatica.",2020,Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group.,"['patients', '96 candidates for the nonsurgical treatment of chronic sciatica', 'Overweight and Obese Patients with Chronic Sciatica']","['Short-Term Low-Calorie Diet', 'short-term low-calorie diet (LCD', 'LCD', 'LCD (intervention) or ordinary diet (control), both in combination with nonsteroidal anti-inflammatory drugs (NSAIDs']","['SFMPQ descriptor scale scores', 'pain and disability', 'mean RMDQ scores and SFMPQ scores', 'Pain and disability', 'short-form McGill pain questionnaire (SFMPQ) and the Roland-Morris disability questionnaire (RMDQ', 'RMDQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585052', 'cui_str': 'Chronic sciatica'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C1690006', 'cui_str': 'Lattice corneal dystrophy Type I'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0282354', 'cui_str': 'Descriptor'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",96.0,0.0627435,Both mean RMDQ scores and SFMPQ scores decreased significantly in the LCD group compared to the control group.,"[{'ForeName': 'Mir Bahram', 'Initials': 'MB', 'LastName': 'Safari', 'Affiliation': 'Department of Orthopaedics, Imam University Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Aisan', 'Initials': 'A', 'LastName': 'Nozad', 'Affiliation': 'Department of Traditional Persian Medicine, School of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ghaffari', 'Affiliation': 'School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Ghavamzadeh', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alijaniha', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0360'] 1654,32428865,"Remdesivir in COVID-19: A critical review of pharmacology, pre-clinical and clinical studies.","BACKGROUND & AIMS Remdesivir is a broad spectrum anti-viral drug that has shown to inhibit SARS-CoV-2, in vitro and in vivo. In absence of any effective treatment for SARS-CoV-2 infection (COVID-19), remdesivir has been tried for a compassionate use in severe COVID-19. Newer randomized controlled studies that have recently become available, showed a mixed result. We aimed to systematically search the literature to understand the pharmacology and clinical effects of remdesivir in patients with COVID-19. METHODS We systematically searched the PubMed, ClinicalTrial.Org and MedRxiv database up till May 5, 2020 using specific key words such as ""Remdesivir"" or 'GS-5734″ AND ""COVID-19"" or ""SARS-CoV-2"" and retrieved all the article published in English language, that have reported the pharmacology and the clinical outcomes of remdesivir in patients with COVID-19. RESULTS Initial compassionate use of remdesivir has shown a fairly good result, but difficult to quantify, in the absence of control arm. While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality. CONCLUSIONS Remdesivir has shown a mixed result in patients with COVID-19 with an acceptable side effect. However, jury is still out while awaiting the results from the forthcoming trials.",2020,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality. ","['Remdesivir in COVID-19', 'patients with COVID-19']",['placebo'],['mortality'],"[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.151411,"While the very first double-blind, placebo-controlled, randomized trial conducted in Wuhan, did not find any significant benefit compared to the control, the preliminary result of another similar multi-country trial has shown a significant faster time to recovery but without any difference in mortality. ","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India. Electronic address: draksingh_2001@yahoo.com.'}, {'ForeName': 'Akriti', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Gynaecology & Obstetrics, G.D Hospital & Diabetes Institute, Kolkata, West Bengal, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Fortis C-DOC Hospital for Diabetes and Allied Sciences, New Delhi, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.018'] 1655,3999081,Effects on upper gastrointestinal mucosa of three delivery systems of potassium as supplement to frusemide administration.,"Thirty healthy volunteers were recruited into a study to determine the effects on the gastrointestinal mucosa of 3 different delivery systems of oral potassium supplementation associated with diuretic therapy (Diumide-K ContinusR tablets, Napp; Lasikal tablets, Hoechst; Lasix and Slow-KR tablets, Hoechst, Ciba). The volunteers were gastroscoped initially and after one week of treatment with one of the three therapies. There was a 60% incidence of erosions in the Lasix + Slow-K group, a 40% incidence in the Lasikal group, but no erosions in the group receiving Diumide-K Continus tablets. It is therefore concluded that Diumide-K Continus tablets incorporate the potassium in a delivery system which is unlikely to cause disruption to the gastrointestinal mucosa.",1985,"There was a 60% incidence of erosions in the Lasix + Slow-K group, a 40% incidence in the Lasikal group, but no erosions in the group receiving Diumide-K Continus tablets.",['Thirty healthy volunteers'],"['oral potassium supplementation associated with diuretic therapy (Diumide-K ContinusR tablets, Napp; Lasikal tablets, Hoechst; Lasix and Slow-KR tablets, Hoechst, Ciba', 'potassium']",['incidence of erosions'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3541460', 'cui_str': 'Potassium supplement therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}, {'cui': 'C0058508', 'cui_str': 'Diumide-K continus'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0699992', 'cui_str': 'Lasix'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",30.0,0.0169348,"There was a 60% incidence of erosions in the Lasix + Slow-K group, a 40% incidence in the Lasikal group, but no erosions in the group receiving Diumide-K Continus tablets.","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'McLoughlin', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1656,32429848,A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.,"BACKGROUND Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual. METHODS We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later. RESULTS Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists. CONCLUSIONS Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.",2020,"RESULTS Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","['A higher proportion of responders vs. non-responders were young (ages 25-44\u2009years), men, and radiation or surgical (vs. medical) oncologists']","['Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online', 'mail and email recruitment strategies', 'American Medical Association MasterFile (n\u2009=\u200913,251) to mail- or email-based recruitment strategies']",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002461', 'cui_str': 'AMA - American Medical Association'}]",[],,0.0660322,"RESULTS Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment.","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA. caitlin.murphy@utsouthwestern.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Craddock Lee', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Geiger', 'Affiliation': 'Healthcare Delivery Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Cox', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Division of Epidemiology, Department of Population & Data Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.'}]",BMC medical research methodology,['10.1186/s12874-020-01014-x'] 1657,32111667,Double Crossed: CDKG1 Regulates Crossover Formation by Stabilizing Meiotic and Somatic Recombination Intermediates.,,2020,,[],[],[],[],[],[],,0.0426808,,"[{'ForeName': 'P William', 'Initials': 'PW', 'LastName': 'Hughes', 'Affiliation': 'Department of Ecology, Environment, and Plant SciencesStockholm UniversityStockholm, Sweden william.hughes@su.se.'}]",The Plant cell,['10.1105/tpc.20.00162'] 1658,32428636,Non-Pharmacological interventions for the anxiety in patients with dementia. A cross-over randomised controlled trial.,"BACKGROUND Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to be a crucial and big problem in dementia. Anxiety several times remains under-diagnosed because it is often considered to be a psychological response to cognitive decline. As only the 10 % of patients were correctly treated, the pharmacological treatment should be well- considered. The aim of this study was to evaluate three non-pharmacological interventions for the treatment of anxiety in dementia. METHODS A cross-over randomised controlled trial with 60 participants (different types and stages of dementia) conducted in Greece. The sample was randomly assigned to 6 different groups of 10 participants each. The non-pharmacological interventions that have been evaluated are: a) Music Therapy b) Exercise and c) Aromatherapy & Massage. The measurements that were used are: MMSE, ACE-R, GDS, FRSSD and NPI questionnaire. The interventions lasted 5 days and there was two days off as a wash-out period. There was no drop-out rate. RESULTS The study showed that the most effective intervention is Music therapy. The second most effective intervention is Exercise and the third one is Aromatherapy and Massage. In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results. (p = <0.05, p = 0.55, accordingly). Caregivers' burden also reduced with MT. In the parenthesis p results indicate Music Therapy's p is less than 0.05 in comparison with the two other interventions and therefore the sequence of the interventions does not interfere with the results, as well (p = <0.05, p = 0.19). CONCLUSIONS Our results are in accordance with the current literature. Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD. Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD, such as lack of sleep, lack of personal time, unhealthy lifestyle, lack of solutions on what to do with their patients etc. The type of music, the duration of the intervention and the long-term benefits remain unclear. There is a big need of further research with stronger possible evaluation methods.",2020,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"['60 participants (different types and stages of dementia) conducted in Greece', 'dementia (BPSD', 'patients with dementia', 'anxiety in dementia']","['Music Therapy', 'Music Therapy b) Exercise and c) Aromatherapy & Massage']","['MMSE, ACE-R, GDS, FRSSD and NPI questionnaire']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.0553418,In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results.,"[{'ForeName': 'Tatiana-Danai', 'Initials': 'TD', 'LastName': 'Dimitriou', 'Affiliation': 'Aristotle University of Thessaloniki, 44 Salaminos Street, Halandri, 15232, Athens, Greece. Electronic address: tt.kirxof@gmail.com.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Verykouki', 'Affiliation': 'Department of Hygiene, Social Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, University Campus, 54124, Thessaloniki, Makedonia, Greece. Electronic address: e.verykouki@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Papatriantafyllou', 'Affiliation': ""3rd Age Center IASIS, 2nd Neurology Dpt., University of Athens, 'Attikon' Hospital, 73 Krimeas Str., Glyfada, Athens, Greece. Electronic address: jpapatriantafyllou@gmail.com.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Konsta', 'Affiliation': '1st Department of Psychiatry, ""Papageorgiou"" General Hospital of Thessaloniki, Aristotle University of Thessaloniki, Greece. Electronic address: konstaa@auth.gr.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazis', 'Affiliation': '3rd Neurology Department, Aristotle University of Thessaloníki, Greece. Electronic address: dimitrios.kazis@gmail.com.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': '1st Department of Neurology, Aristotle University of Thessaloniki, Makedonia, 3 Despere Street, Thessaloniki, Greece. Electronic address: tsolakim1@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112617'] 1659,32429553,Effects of Cognitive Behavioral Group Program for Mental Health Promotion of University Students.,"This study aimed to explore the effects of a group cognitive behavioral program on depression, self-esteem, and interpersonal relations among undergraduate students. A non-equivalent control group pretest-posttest design was used. A convenient sample of 37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used. Data were collected from February 4, 2019 to June 18, 2019. The experimental group received eight sessions of the program, which were scheduled twice a week, with each session lasting 90 min. Collected data were analyzed using a chi-square test, Fisher's exact test, independent t -test, and repeated measures ANOVA by SPSS/WIN 23.0 (SPSS, Inc., Chicago, IL, USA). The interaction of group and time was significant, indicating that the experimental group showed an improvement in depression, self-esteem, and personal relationship compared to the control group. A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups. The study results revealed that the group cognitive behavioral program was effective in reducing depression and improving self-esteem and interpersonal relation. Therefore, the group cognitive behavioral program can be used for promoting the mental health of students as well as for preventing depression in a university setting.",2020,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","['37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used', 'undergraduate students', 'Mental Health Promotion of University Students', 'Data were collected from February 4, 2019 to June 18, 2019']","['Cognitive Behavioral Group Program', 'group cognitive behavioral program']","['depression and improving self-esteem and interpersonal relation', 'time interaction for depression, self-esteem, and personal relationship', 'depression, self-esteem, and interpersonal relations', 'depression, self-esteem, and personal relationship']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0129976,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","[{'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103500'] 1660,32434376,Comparison of Auricular Therapy with Sham in Children with Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.,"Objectives: Several studies have shown the clinical effects of auricular therapy for some neuropsychological disorders. The aim of this study is to compare the effectiveness of auricular therapy with the sham procedure in attention deficit hyperactivity disorder (ADHD). Design: Randomized sham-controlled trial. Settings/Location: Welfare Centers of Tehran (Iran). Subjects: Fifty children with ADHD (6-14 years old). Interventions: Patients were randomly assigned into two groups to receive either auricular therapy (Group A) or a sham procedure (Group B) once a week for 6 weeks. Outcome measures: The Children Symptom Inventory (CSI-4) and the parent's version of the Conners Comprehensive Behavior Rating Scale were used to assess the severity of symptoms of attention deficit (AD) and hyperactivity (HA). Outcome evaluation data was obtained at the first and seventh weeks after the interventions. Data were analyzed by SPSS software using Friedman and Mann-Whitney U tests. Results: There were 23 patients in group A and 21 patients in group B who completed the study. Based on the CSI-4 assessment, AD scores decreased from the mean (±standard deviation) of 18.39 (±5.44) to 15.39 (±5.89), p  = 0.006 in group A, whereas the mean AD scores for group B only changed from 15.0 (±6.4) to 14.9 (±5.94), p  = 0.55 in group B. In addition, the mean of the HA scores decreased from 18.0 (±6.73) to 13.3 (±6.75), p  = 0.001 in group A, whereas the change in HA scores in group B only diminished and from 11.85 (±6.44) to 11.45 (±5.44), p  = 0.74. The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed. Conclusion: Subjects who received auricular therapy in acupuncture points achieved a statistically significant greater reduction in AD and HA symptoms when compared with subjects who received sham acupuncture points.",2020,"The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed. ","['Subjects: Fifty children with ADHD (6-14 years old', 'Settings/Location: Welfare Centers of Tehran (Iran', '23 patients in group A and 21 patients in group B who completed the study', 'Children with Attention Deficit/Hyperactivity Disorder']","['auricular therapy', 'auricular therapy in acupuncture points', 'Auricular Therapy with Sham']","[""Children Symptom Inventory (CSI-4) and the parent's version of the Conners Comprehensive Behavior Rating Scale"", 'CSI-4 assessment, AD scores', 'AD and HA symptoms', 'mean AD scores', 'severity of symptoms of attention deficit (AD) and hyperactivity (HA', 'CSI-4 assessments and the scores on the Conners questionnaire', 'mean of the HA scores', 'change in HA scores', 'side effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3494227', 'cui_str': 'Spinocranial Irradiation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",50.0,0.0874341,"The CSI-4 assessments and the scores on the Conners questionnaire significantly decreased after the first week of intervention ( p  = 0.04) in group A, but not in group B. No side effects were observed. ","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Binesh', 'Affiliation': 'Department of Research, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Daghighi', 'Affiliation': 'Department of Psychiatry, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shirazi', 'Affiliation': 'Spiritual Health Research Center, Tehran Institute of Psychiatry, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Oleson', 'Affiliation': ""Department of Traditional Oriental Medicine, Emperor's College of Traditional Oriental Medicine, Santa Monica, CA, USA.""}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem-Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0477'] 1661,32434686,Corrigendum to 'Efficacy and safety of food fortification to improve Vitamin D intakes of older adults' [Nutrition 75-76 (2020)].,,2020,,"[""older adults' [Nutrition 75-76 (2020""]",['food fortification'],['Vitamin D intakes'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",,0.01844,,"[{'ForeName': 'Aislinn', 'Initials': 'A', 'LastName': 'McCourt', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Breige A', 'Initials': 'BA', 'LastName': 'McNulty', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Walton', 'Affiliation': 'School of Biological Sciences, Cork Institute of Technology, Cork, Ireland.'}, {'ForeName': 'Aifric', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland. Electronic address: Aifric.osullivan@ucd.ie.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110837'] 1662,32429406,Biomarkers of Muscle Metabolism in Peripheral Artery Disease: A Dynamic NIRS-Assisted Study to Detect Adaptations Following Revascularization and Exercise Training.,"We assessed whether muscle metabolism biomarkers (MMb) identified by near-infrared spectroscopy (NIRS) are valid for determining adaptations following revascularization or exercise training in peripheral artery disease (PAD). Eighteen patients (males n = 13; 69 ± 7 years) were randomized to receive revascularization (Rev = 6) or pain-free home-based exercise (Ex = 12). MMb were safely collected via a NIRS-assisted treadmill test as area-under-curve for the spectra of oxygenated (-oxy), deoxygenated (-deoxy), differential (-diff) and total (-tot) hemoglobin traces. MMb, ankle-brachial index (ABI), pain-free (PFWD) and 6-minute (6MWD) walking distances were assessed at baseline and after four months. MMb were correlated at baseline with ABI (MMb-oxy r = 0.46) and 6MWD (MMb-tot r = 0.51). After treatments, MMb-oxy showed an expected increase, which was more relevant for Rev group than the Ex (56% vs. 20%), with trends towards normalization for the other MMb. These changes were significantly correlated with variations in ABI (MMb-oxy r = 0.71; p = 0.002) and 6MWD (MMb-tot r = 0.58; p = 0.003). The MMb-diff in Rev group and MMb-deoxy in Ex group at baseline predicted clinical outcomes being correlated with PFWD improvements after 4-month ( r =-0.94; p = 0.005 and r = -0.57; p = 0.05, respectively). A noninvasive NIRS-based test, feasible in a clinical setting, identified muscle metabolism biomarkers in PAD. The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.",2020,"The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.","['Eighteen patients (males n = 13; 69 ± 7 years', 'Peripheral Artery Disease', 'peripheral artery disease (PAD']","['revascularization or exercise training', 'muscle metabolism biomarkers (MMb) identified by near-infrared spectroscopy (NIRS', 'revascularization (Rev = 6) or pain-free home-based exercise', 'Revascularization and Exercise Training']","['MMb', 'PFWD improvements', 'MMb, ankle-brachial index (ABI), pain-free (PFWD) and 6-minute (6MWD) walking distances']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.034182,"The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Section of Sports Sciences, Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Italy-Via Luigi Borsari 46, 44121 Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Section of Sports Sciences, Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Italy-Via Luigi Borsari 46, 44121 Ferrara, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ficarra', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Elpiniki', 'Initials': 'E', 'LastName': 'Tsolaki', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation; Department of Neurosciences/Rehabilitation, University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zamboni', 'Affiliation': 'Vascular Diseases Center, University of Ferrara, Italy-Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation; Department of Neurosciences/Rehabilitation, University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Gasbarro', 'Affiliation': 'Unit of Vascular and Endovascular Surgery; University Hospital of Ferrara. Via Aldo Moro 8, 44124 Ferrara, Italy.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10050312'] 1663,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS. METHODS The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period. RESULTS The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2 = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. CONCLUSIONS Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106'] 1664,2681770,Placental angiogenic and growth factors in the treatment of chronic varicose ulcers: preliminary communication.,A short-term clinical study on the effect of purified angiogenic and growth factors from human term placenta in the treatment of chronic varicose ulcers was carried out in 18 patients. Patients were randomly allocated to receive a maximum of two dressings containing or not containing these factors. The amount of granulation and epithelial tissue was clinically estimated 48 hours after each application. Patients treated with placental angiogenic and growth factors showed increased granulation and epithelial tissue. These results indicate that placental factors may be used for acceleration of wound healing.,1989,Patients treated with placental angiogenic and growth factors showed increased granulation and epithelial tissue.,"['chronic varicose ulcers was carried out in 18 patients', 'chronic varicose ulcers']",['purified angiogenic and growth factors from human term placenta'],"['amount of granulation and epithelial tissue', 'Placental angiogenic and growth factors', 'granulation and epithelial tissue']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}]","[{'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}]",18.0,0.0141359,Patients treated with placental angiogenic and growth factors showed increased granulation and epithelial tissue.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Burgos', 'Affiliation': 'Blond McIndoe Centre for Medical Research, Queen Victoria Hospital, East Grinstead, Sussex.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Herd', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Bennett', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1665,31811627,Effect of a Single-Session Communication Skills Training on Empathy in Medical Students.,"OBJECTIVE Empathy scores have been found to decline over the years spent in medical school. The authors aimed to evaluate the change in empathy levels in medical students following a single-session communication skills training. METHODS Eighty-two second-year medical students were randomized into intervention and control groups. The intervention comprised of a single-session empathetic communication skills training using PowerPoint, video clips, and roleplay. Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks. RESULTS The mean JSE score of the intervention group was 109.7 ± 11.8 at baseline, with significant improvement post-intervention (114.2 ± 10.6, p = 0.014). However, the score declined at the 3-week follow-up (106.8 ± 11.8). The mean baseline JSE score of the control group was 107.5 ± 12.4, with a decline at follow-up (101.8 ± 16.0). Though both groups showed a decline in the JSE score at follow-up, the decline was significant only for the control group (p = 0.020), which did not receive the training. CONCLUSIONS The study showed significant improvement immediately, and lower decline at follow-up, in empathy levels following a communication skills training. The findings suggest a need to incorporate a regular training program into the existing medical curriculum, to enhance empathy and prevent its decline over the years.",2020,"Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks. ","['Medical Students', 'Eighty-two second-year medical students', 'medical students following a single-session communication skills training']",['Single-Session Communication Skills Training'],"['Jefferson Scale of Empathy-Student version (JSE', 'JSE score', 'empathy levels', 'mean JSE score', 'mean baseline JSE score']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0212813,"Empathy was assessed using the Jefferson Scale of Empathy-Student version (JSE) at baseline, post-intervention (for the intervention group), and at follow up after 3 weeks. ","[{'ForeName': 'Prima Cheryl', 'Initials': 'PC', 'LastName': ""D'souza"", 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Smitha L', 'Initials': 'SL', 'LastName': 'Rasquinha', 'Affiliation': 'Father Muller Medical College, Mangalore, Karnataka, India. smithaljr@gmail.com.'}, {'ForeName': 'Trina Lucille', 'Initials': 'TL', 'LastName': ""D'souza"", 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Animesh', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Vaman', 'Initials': 'V', 'LastName': 'Kulkarni', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Keshava', 'Initials': 'K', 'LastName': 'Pai', 'Affiliation': 'Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry,['10.1007/s40596-019-01158-z'] 1666,32138957,Why the US Centers for Medicare and Medicaid Services (CMS) should have required a randomized trial of Foundation Medicine (F1CDx) before paying for it.,,2018,,[],[],[],[],[],[],,0.0267803,,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': 'Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, USA; Department of Preventive Medicine and Public Health, Oregon Health and Science University, Portland, USA; Center for Health Care Ethics, Oregon Health and Science University, Portland, USA. Electronic address: prasad@ohsu.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdx786'] 1667,17094121,Caffeine attenuates practice effects in word stem completion as measured by fMRI BOLD signal.,"Caffeine ingestion results in increased brain cell metabolism (Nehlig et al. [1992] Brain Res Brain Res Rev 17:139-170) and decreased cerebral blood flow (Field et al. [2003] Radiology 227:129-135; Mulderink et al. [2002] Neuroimage 15:37-44). The current study investigated the effect of caffeine in a word stem completion task using only novel word stems (no repeated stimuli). Resting perfusion was measured with arterial spin labeled perfusion MRI, along with blood oxygenation level-dependent (BOLD) signal before and after ingestion of regular coffee, decaffeinated coffee, and water. Based on previous research (Laurienti et al. [2002] Neuroimage 17:751-757; Mulderink et al. [2002] Neuroimage 15:37-44), we hypothesized that caffeine would result in increased BOLD signal intensity and extent of BOLD activation. As expected, caffeine resulted in a significant decrease in cerebral perfusion. However, both the control and caffeine groups showed an increase in BOLD signal amplitude across two sets of novel word stems. Additionally, the control group showed a 50% reduction in the extent of BOLD activation, while the caffeine group showed no change in activation extent. Neither group showed changes in BOLD baseline signal over time, which had been suggested to mediate caffeine-related BOLD signal changes. The results suggest that caffeine may attenuate general task practice effects that have been described in recent functional MRI studies of word stem completion (Buckner et al. [2000] Brain 123:620-640).",2007,"Neither group showed changes in BOLD baseline signal over time, which had been suggested to mediate caffeine-related BOLD signal changes.","['1992', '2000']","['caffeine', 'Caffeine ingestion', 'Caffeine']","['fMRI BOLD signal', 'extent of BOLD activation', 'blood oxygenation level-dependent (BOLD) signal', 'brain cell metabolism', 'BOLD signal intensity and extent of BOLD activation', 'BOLD signal amplitude', 'cerebral perfusion', 'cerebral blood flow', 'BOLD baseline signal']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",,0.0350523,"Neither group showed changes in BOLD baseline signal over time, which had been suggested to mediate caffeine-related BOLD signal changes.","[{'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Bendlin', 'Affiliation': 'Department of Psychology, Cognition and Neuroimaging Laboratories, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Trouard', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ryan', 'Affiliation': ''}]",Human brain mapping,[] 1668,17290373,Tyrosine depletion alters cortical and limbic blood flow but does not modulate spatial working memory performance or task-related blood flow in humans.,"Dopamine appears critical in regulating spatial working memory (SWM) within the PFC of non-human primates; however findings in humans are less clear. Recent studies of the effects of global depletion of dopamine via acute tyrosine/phenylalanine depletion (TPD) on SWM task performance have yielded inconsistent results, which may be partly related to task differences. These previous studies do not address whether TPD can directly impair PFC functioning. The current study investigated the effects of TPD on (1) regional cerebral blood flow (rCBF) during a SWM n-back task using H(2) (15)O Positron Emission Tomography (PET), and (2) behavioural performance on three different SWM tasks. Ten healthy males were scanned twice: once following a placebo (balanced) amino acid mixture and once following an equivalent mixture deficient in tyrosine/phenylalanine (TPD condition). Participants completed two additional delayed-response tasks to examine whether differences in response demands influenced TPD effects on performance. TPD resulted in widespread increases in rCBF, with maximum increases in the region of the parahippocampal gyrus bilaterally, left inferior frontal gyrus, and the putamen. TPD related rCBF reductions were observed in the medial frontal gyrus bilaterally, right inferior temporal gyrus and the pons. Despite widespread changes in blood flow following TPD, no specific effects on SWM neural networks or task performance were observed. The use of three different SWM tasks suggests that task differences are unlikely to account for the lack of effects observed. These findings question the capacity of TPD to consistently modulate dopamine function and SWM neural networks in humans.",2007,"TPD related rCBF reductions were observed in the medial frontal gyrus bilaterally, right inferior temporal gyrus and the pons.","['Ten healthy males', 'humans']","['TPD', 'Dopamine', 'dopamine via acute tyrosine/phenylalanine depletion (TPD', 'placebo (balanced) amino acid mixture and once following an equivalent mixture deficient in tyrosine/phenylalanine (TPD condition']","['regional cerebral blood flow (rCBF) during a SWM n-back task using H(2) (15)O Positron Emission Tomography (PET), and (2) behavioural performance', 'rCBF', 'TPD related rCBF reductions', 'SWM neural networks or task performance', 'blood flow']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",10.0,0.129288,"TPD related rCBF reductions were observed in the medial frontal gyrus bilaterally, right inferior temporal gyrus and the pons.","[{'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Brain Sciences Institute, Swinburne University of Technology, Melbourne, Australia. kellis@unimelb.edu.au'}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Naga Venkatesha Murthy', 'Affiliation': ''}, {'ForeName': 'Sarah F B', 'Initials': 'SF', 'LastName': 'McTavish', 'Affiliation': ''}, {'ForeName': 'Pradeep J', 'Initials': 'PJ', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Grasby', 'Affiliation': ''}]",Human brain mapping,[] 1669,17277261,What is the place for placebo in the management of psychogenic disease?,,2007,,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0290374,,"[{'ForeName': 'Erle C H', 'Initials': 'EC', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Raymond C S', 'Initials': 'RC', 'LastName': 'Seet', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1670,32089107,Lingering guilt and shame: Emotional burdens upon those who intended but failed to apologize.,"Prior research has shown that greater willingness to apologize for an offense is prompted by greater guilt but lesser shame. Yet little work examined whether apologies indeed resolve moral emotions. This study investigated how the absence of apology psychologically affects harm-doers when they recall a past offense. Undergraduates ( N = 284) were randomly assigned to one of the four experimental conditions wherein they recalled a past incident in which they hurt, offended, angered, or had some other negative effect on another person. Harm-doers who intended but failed to apologize reported greater PFQ-2 state guilt and shame, compared to others who refused to apologize or whose apologies were rejected. However, similar results were not found for ESS state shame. Results suggest that failing to apologize may impede transgressors from relieving moral emotional burdens, but only for those who intended to apologize.",2020,"Harm-doers who intended but failed to apologize reported greater PFQ-2 state guilt and shame, compared to others who refused to apologize or whose apologies were rejected.",['Undergraduates ( N =\xa0284'],[],"['PFQ-2 state guilt and shame', 'Lingering guilt and shame', 'Emotional burdens', 'ESS state shame']",[],[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",284.0,0.0215423,"Harm-doers who intended but failed to apologize reported greater PFQ-2 state guilt and shame, compared to others who refused to apologize or whose apologies were rejected.","[{'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of Texas at Austin.'}]",The Journal of social psychology,['10.1080/00224545.2020.1732857'] 1671,31741279,Using Animation to Self-Report Health: A Randomized Experiment with Children.,"BACKGROUND The Child Health Utility-9D (CHU-9D) is the only generic preference-based measure specifically developed to elicit health-related quality of life directly from children aged 7-11 years. The aim of this study was to investigate whether the use of animation on a touch screen device (tablet) is a better way of collecting health status information from children aged 4-14 years compared to a traditional paper questionnaire. The specific research questions were firstly, do young children (4-7 years) find an animated questionnaire easier to understand; secondly, independent of age, is completion of an animated questionnaire easier for sick children in hospital settings; and thirdly, do children's preferences for the different formats of the questionnaire vary by the age of the child. METHODS Using a balanced cross-over trial, we administered different formats of the CHU-9D to 221 healthy children in a school setting and 217 children with health problems in a hospital setting. The study tested five versions of the CHU-9D questionnaire: paper text, tablet text, tablet still image, paper image and tablet animation. RESULTS Our results indicated that the majority of the children aged 4-7 years found the CHU-9D questions easy to answer independent of the format of the questionnaire administered. Amongst children aged 7-14 with health problems, the format of questionnaire influenced understanding. Children aged 7-11 years found the tablet image and animation formats easier compared to text questionnaires, while the oldest children in hospital found text-based questionnaires easier compared to image and animation. CONCLUSION Children in all three age groups preferred animation on a tablet to other methods of assessment. Our results highlight the potential for using an animated preference-based measure to assess the health of children as young as 4 years.",2020,"CONCLUSION Children in all three age groups","['children aged 7-11\xa0years', 'children aged 7-14 with health problems', ""sick children in hospital settings; and thirdly, do children's preferences for the different formats of the questionnaire vary by the age of the child"", 'children aged 4-14\xa0years', 'Children', 'Children aged 7-11\xa0years', 'Children in all three age groups', '221 healthy children in a school setting and 217 children with health problems in a hospital setting', 'young children (4-7\xa0years']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]",[],[],221.0,0.0220765,"CONCLUSION Children in all three age groups","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Guerriero', 'Affiliation': ""Università degli Studi di Napoli Federico II, Via Cinthia Monte Sant'Angelo, 80122, Naples, Italy. carla.guerriero@unina.it.""}, {'ForeName': 'Neus Abrines', 'Initials': 'NA', 'LastName': 'Jaume', 'Affiliation': 'Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Diaz-Ordaz', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Katherine Loraine', 'Initials': 'KL', 'LastName': 'Brown', 'Affiliation': 'Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Wray', 'Affiliation': 'Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Ashworth', 'Affiliation': 'Animation, Royal College of Art, London, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Abbiss', 'Affiliation': 'Animation, Royal College of Art, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",The patient,['10.1007/s40271-019-00392-9'] 1672,31519466,Effects of an Evidence-Informed Healthy Eating Blog on Dietary Intakes and Food-Related Behaviors of Mothers of Preschool- and School-Aged Children: A Randomized Controlled Trial.,"BACKGROUND Although social media such as blogs are still considered innovative communication technologies, some registered dietitians (RDs) are using them to promote healthy eating; however, evidence regarding the effects of healthy eating blogs on users' diet is lacking. OBJECTIVE This study evaluated the effects of an evidence-informed healthy eating blog written by an RD on dietary intakes, with a focus on vegetables and fruit and milk and alternatives consumption, and food-related behaviors of Canadian mothers. DESIGN This study was a parallel, randomized, controlled trial. PARTICIPANTS/SETTING Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth. INTERVENTION The intervention was exclusively delivered through an evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption in mothers-for 6 months at a dose of one new post written by an RD each week. Mothers could engage with the RD and fellow participants by posting comments on the blog. MAIN OUTCOME MEASURES Main outcomes were daily intakes of vegetables and fruit and milk and alternatives. Outcome assessments were performed at baseline, 3 months, and at the end of the 6-month intervention. STATISTICAL ANALYSIS Differences between the groups were examined using mixed linear models. RESULTS At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). CONCLUSIONS A healthy eating blog, at a dose of 1 post per week, had no effects on dietary intakes, food-related behaviors, and body weight of mothers after 6 months. Methodologic issues are discussed to inform future health behavior research using blogs to promote healthy eating.",2020,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). ","['Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth', 'Mothers of Preschool- and School-Aged Children', 'Canadian mothers']","['evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption', 'Evidence-Informed Healthy Eating Blog']","['daily intakes of vegetables and fruit and milk and alternatives', 'dietary intakes, food-related behaviors, and body weight of mothers', 'intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.063081,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). ","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.016'] 1673,17082305,The first randomized trial of aspirin for heart attack and the advent of systematic overviews of trials.,,2006,,[],['aspirin'],[],[],"[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]",[],,0.0437443,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Elwood', 'Affiliation': 'Department of Epidemiology, Statistics and Public Health, Cardiff University, University Hospital of Wales, Cardiff CF14 4XN, UK. pelwood@doctors.org.uk'}]",Journal of the Royal Society of Medicine,[] 1674,17080442,Methylphenidate-induced activation of the anterior cingulate but not the striatum: a [15O]H2O PET study in healthy volunteers.,"The dopaminergic system has been implicated in the pathogenesis and treatment of a variety of neuropsychiatric disorders, such as schizophrenia, depression, and addiction. (Dys)function of the dopaminergic system may be studied by combining [15O]H2O PET with a dopaminergic drug challenge. In this pilot study we investigated the suitability of the dopamine reuptake blocker methylphenidate (MP) as a dopaminergic probe. Measurements of regional cerebral blood flow (rCBF) were made at 10 and 30 min after placebo and MP (0.25 mg/kg) injection to seven healthy volunteers. During scanning the behavioral condition of the subjects was standardized using a continuous performance task. Growth hormone levels were assessed and subjective ratings were obtained. MP significantly elevated growth hormone levels. After receiving MP, the subjective experience varied from neutral to highly pleasurable. Ten minutes after MP administration, significant relative increases in rCBF were found in the rostral anterior cingulate (AC), temporal poles, and the supplementary motor area. Significant reductions were seen in the superior temporal gyri, right medial frontal gyrus, and right inferior parietal cortex. At 30 min after MP administration, increases were seen in the AC, temporal pole, and right cerebellum. No changes were observed in the striatum. The activation in the right rostral AC was significantly higher in the subjects with the highest euphoria scores compared to the subjects with minimal MP-induced changes in euphoria. We suggest that the combined MP challenge with functional imaging, as described in our study, may be a useful tool to study the functional integrity of the dopaminergic system in psychiatric disorders.",2007,"Ten minutes after MP administration, significant relative increases in rCBF were found in the rostral anterior cingulate (AC), temporal poles, and the supplementary motor area.","['seven healthy volunteers', 'healthy volunteers']","['Methylphenidate', 'dopamine reuptake blocker methylphenidate (MP', 'placebo and MP']","['elevated growth hormone levels', 'superior temporal gyri, right medial frontal gyrus, and right inferior parietal cortex', 'rCBF', 'Growth hormone levels', 'euphoria', 'regional cerebral blood flow (rCBF', 'rostral anterior cingulate (AC), temporal poles, and the supplementary motor area']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202056', 'cui_str': 'Growth hormone measurement (procedure)'}, {'cui': 'C0152309', 'cui_str': 'Gyrus Temporalis Superior'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0458310', 'cui_str': 'Medial Frontal Gyrus'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0149552', 'cui_str': 'Structure of temporal pole'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}]",7.0,0.0348785,"Ten minutes after MP administration, significant relative increases in rCBF were found in the rostral anterior cingulate (AC), temporal poles, and the supplementary motor area.","[{'ForeName': 'Joanna I', 'Initials': 'JI', 'LastName': 'Udo de Haes', 'Affiliation': 'Department of Biological Psychiatry, University Medical Center Groningen, Groningen, The Netherlands. joanna2706@fastmail.fm'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Maguire', 'Affiliation': ''}, {'ForeName': 'Piet L', 'Initials': 'PL', 'LastName': 'Jager', 'Affiliation': ''}, {'ForeName': 'Anne M J', 'Initials': 'AM', 'LastName': 'Paans', 'Affiliation': ''}, {'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'den Boer', 'Affiliation': ''}]",Human brain mapping,[] 1675,31301135,HLA-I Associated Adaptation Dampens CD8 T-Cell Responses in HIV Ad5-Vectored Vaccine Recipients.,"HLA-I-associated human immunodeficiency virus (HIV) adaptation is known to negatively affect disease progression and CD8 T-cell responses. We aimed to assess how HLA-I-associated adaptation affects HIV vaccine-induced CD8 T-cell responses in 2 past vaccine efficacy trials. We found that vaccine-encoded adapted epitopes were less immunogenic than vaccine-encoded nonadapted epitopes, and adapted epitope-specific responses were less polyfunctional than nonadapted epitope-specific responses. Along those lines, vaccine recipients with higher HLA-I adaptation to the Gag vaccine insert mounted less polyfunctional CD8 T-cell responses at the protein level. Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation. These findings suggest that HLA-I-associated adaptation is an important consideration for strategies aiming to induce robust CD8 T-cell responses.",2019,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.",['HIV Ad5-Vectored Vaccine Recipients'],[],"['polyfunctional CD8 T-cell responses', 'HLA-I Associated Adaptation Dampens CD8 T-Cell Responses']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0528480', 'cui_str': 'Presenilin 2'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],"[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",,0.017682,"Breadth of response, which correlated with viral control in recipients who became infected, is also dampened by HLA-I adaptation.","[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Boppana', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sterrett', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Files', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kristen W', 'Initials': 'KW', 'LastName': 'Cohen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz368'] 1676,31517964,Effect of a Prize-Linked Savings Intervention on Savings and Healthy Behaviors Among Men in Kenya: A Randomized Clinical Trial.,"Importance Interventions to reduce men's alcohol use and risky sexual behaviors are essential for reducing new HIV infections in high-prevalence settings in sub-Saharan Africa. Prize-linked savings accounts can motivate savings and may decrease expenditures on risky behaviors, but few studies have examined the HIV prevention potential of such savings interventions among men. Objective To evaluate the effect of prize-linked savings accounts on savings behavior and expenditures on alcohol, gambling, and transactional sex among men in Kenya. Design, Setting, and Participants Randomized clinical trial among communities in Siaya County, Kenya. Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018. Interventions Eligible participants were offered savings accounts endowed with 1000 Kenya shillings (US $10) and randomized (1:1) to receive weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest. Main Outcomes and Measures The primary outcome was an indicator of whether a participant saved any money in the bank account (intent-to-treat analysis) during the study period. Secondary outcomes included total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex. Results A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts. Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23). During a mean (SD) follow-up of 9 (2) weeks, 37.3% (50 of 134) in the intervention group saved money in a bank account vs 27.2% (37 of 136) in the control group, although the difference was not statistically significant (odds ratio, 1.62; 95% CI, 0.96-2.74). The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant. The intervention did not have a significant effect on alcohol, gambling, and transactional sex expenditures. Conclusions and Relevance Prize-linked savings accounts modestly increased savings among high-risk men in Kenya over a 9-week period, but the difference compared with standard-interest savings accounts was not significant. Testing of more powerful savings products is needed to assess whether such savings-led interventions can reduce men's expenditures on alcohol, gambling, and transactional sex. Trial Registration Social Science Registry identifier: AEARCTR-0003224, and ClinicalTrials.gov identifier: NCT04013295.",2019,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[""Participants' mean age was 33.7 years (interquartile range, 13.5 years), 84.3% (253 of 300) were married, and the mean weekly earnings were US $30 (interquartile range, US $23"", 'A total of 425 men were screened, 329 (77.4%) met eligibility criteria, 300 (70.6%) were enrolled (with 152 randomized to the intervention group and 148 to the control group), and 270 of 300 (90.0%) opened bank accounts', 'Participants were men 21 years or older who owned a mobile phone, were engaged in fishing or transportation sector work, and were willing to open an account with a local bank; they were screened for eligibility between September 3 and October 5, 2018', 'men', 'Men in Kenya', 'communities in Siaya County, Kenya', 'men in Kenya']","['prize-linked savings', 'weekly lottery-based rewards contingent on growth in savings balance or to a control group that received standard interest', 'Prize-Linked Savings Intervention']","['total amount saved in the bank account, total amount saved in all sources, and expenditures on alcohol, gambling, and transactional sex', 'higher growth in bank savings balances', 'indicator of whether a participant saved any money in the bank account (intent-to-treat analysis', 'Savings and Healthy Behaviors', 'total savings', 'alcohol, gambling, and transactional sex expenditures', 'savings behavior and expenditures on alcohol, gambling, and transactional sex']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0080049', 'cui_str': 'Prizes'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4042872', 'cui_str': 'Bank Accounts'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",425.0,0.0919333,"The intervention group had higher growth in bank savings balances (US $10.26; 95% CI, US $5.00-US $58.20 vs US $4.87; 95% CI, US $0.67-US $9.00) and higher total savings from all sources (US $201; 95% CI, US $133-US $269 vs US $145; 95% CI, US $88-US $202), but neither difference was statistically significant.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moscoe', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.11162'] 1677,31513027,Comparison of Short-Term Efficacy Between Endoscopic Submucosal Tunnel Dissection and Endoscopic Submucosal Dissection in Treatment of Wide Esophageal Squamous Cell Carcinoma of Early Stage.,"GOAL The goal of this study was to compare the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) with endoscopic submucosal dissection (ESD) for the removal of early-stage esophageal squamous cancer wider than or equal to one half the circumference of the esophagus. BACKGROUND Although ESD has been successfully applied for resection of early-stage esophageal cancer, there are still technical challenges and postoperative stenosis when it is applied to treat large lesions. PATIENTS AND METHODS A total of 40 patients with early-stage esophageal cancer wider than or equal to one half its circumference were enrolled in this study and randomly assigned to an ESTD or ESD group for treatment of esophageal superficial squamous cell carcinoma. All of the patients received oral steroids after endoscopic dissection. We then compared the 2 groups in terms of average operating time, dissection speed, en bloc resection rate, R0 resection rate, and complications during a 1-year follow-up period. RESULTS The dissection speed in the ESTD group was significantly faster than that in the ESD group (P=0.047). There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively). There were also no significant differences in perforation, bleeding, or stenosis rates between the ESTD and ESD group (P=1.000, 0.748, 1.000, respectively). CONCLUSION Both ESTD and ESD are safe and effective therapies for early-stage esophageal cancer wider than or equal to one half the esophageal circumference. The dissection speed of ESTD is faster than that of ESD.",2020,"There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively).","['esophageal superficial squamous cell carcinoma', 'Wide Esophageal Squamous Cell Carcinoma of Early Stage', '40 patients with early-stage esophageal cancer wider than or equal to one half its circumference']","['endoscopic submucosal tunnel dissection (ESTD) with endoscopic submucosal dissection (ESD', 'ESTD or ESD', 'Endoscopic Submucosal Tunnel Dissection and Endoscopic Submucosal Dissection', 'ESD', 'oral steroids']","['operating time, en bloc resection rates, or R0 resection rates', 'efficacy and safety', 'perforation, bleeding, or stenosis rates', 'average operating time, dissection speed, en bloc resection rate, R0 resection rate, and complications', 'dissection speed']","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",40.0,0.0222927,"There were no significant differences in operating time, en bloc resection rates, or R0 resection rates between the ESTD and ESD group (P=0.319, 1.000, 1.000, respectively).","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Keyi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Thoracic Surgery.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Cui', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Hejun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Departments of Gastroenterology.'}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Departments of Gastroenterology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001266'] 1678,15229266,Scoring posters at scientific meetings: first impressions count.,"Many specialist societies present ""best poster"" prizes, yet without generally agreed assessment methods. 31 posters at a neurology meeting were divided randomly into two sets; 14 neurologists, randomized into two groups, were each assigned one poster set. They ""quick scored"" the first half, viewing posters for 10-15 seconds, and ""detailed scored"" the others. 11 administrators and pharmaceutical representatives quick scored all posters. Neurologists' quick score ranking correlated highly (r=0.75) with other neurologists' detailed score ranking, and identified four of their six top-ranked posters. Correlations were strongest for presentation (r=0.65), message (r=0.65) and star-quality (r=0.64), but weak for facts (r=0.09), originality (r=0.15) or science (r=0.02). Non-neurologists could not identify the posters ranked highest by neurologists. We conclude that quick ranking by specialists can efficiently identify the best posters for more detailed assessment. On this basis we offer poster-scoring guidelines for use at scientific meetings.",2004,"Neurologists' quick score ranking correlated highly (r=0.75) with other neurologists' detailed score ranking, and identified four of their six top-ranked posters.",['31 posters at a neurology meeting'],[],['star-quality'],"[{'cui': 'C0376675', 'cui_str': 'Poster'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",6.0,0.016873,"Neurologists' quick score ranking correlated highly (r=0.75) with other neurologists' detailed score ranking, and identified four of their six top-ranked posters.","[{'ForeName': 'Philip E M', 'Initials': 'PE', 'LastName': 'Smith', 'Affiliation': 'Department of Neurology, University Hospital of Wales, College of Medicine, Cardiff CF14 4XW, Wales, UK. SmithPE@cardiff.ac.uk'}, {'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Fuller', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Dunstan', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1679,30721985,Effect of Reactive Balance Training Involving Repeated Slips and Trips on Balance Recovery Among Older Adults: A Blinded Randomized Controlled Trial.,"BACKGROUND This study examined whether reactive balance training (exposures to slips and trips) could improve balance recovery and reduce perturbation-induced falls among older adults. METHODS Forty-four community-dwelling older adults participated in a parallel, blinded randomized controlled trial conducted in a research institute in Sydney, Australia in 2017-2018 (ACTRN12617000564358). The intervention group (n = 22) underwent three 40 minutes sessions (total 120 minutes) that exposed them to (1) 20 trips, (2) 20 slips, and (3) 10 trips and 10 slips in mixed order, over 2 days. The control group (n = 22) received one 40 minutes session of sham training. The primary outcome was falls (>30% body weight in harness) when exposed to trips and slips at post-assessment. RESULTS At post-assessment, a total of 51 falls (23 and 27 falls from induced slips and trips, respectively) were recorded in the laboratory. Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR] = 0.40, 95% confidence interval [CI] = 0.22-0.76), slip falls (RR = 0.33, 95% CI = 0.12-0.90) and trip falls (RR = 0.49, 95% CI = 0.21-1.12). Eight participants reported adverse events (5 in the intervention group and 3 in the control group) which were related mainly to discomfort caused by a suboptimal harness used in the initial stages of the trial. CONCLUSIONS The reactive balance training reduced perturbation-induced falls by 60% indicating improved balance recovery from trips and slips. A comfortable safety harness system is essential to prevent discomfort. Reactive balance training may complement traditional exercise programs in fall prevention interventions.",2019,"Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR]=0.40, 95% confidence interval [CI]=0.22-0.76), slip falls (RR=0.33, 95% CI=0.12-0.90) and trip falls (RR=0.49, 95% CI=0.21-1.12).","['Methods\n\n\nForty-four community-dwelling older adults', 'older adults']","['reactive balance training (exposures to slips and trips', 'reactive balance training', 'Reactive balance training', 'one 40-min session of sham training']","['trip falls', 'falls (>30% body weight in harness', 'adverse events', 'slip falls', 'total falls']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0221188', 'cui_str': 'Tripping (event)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0221188', 'cui_str': 'Tripping (event)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3873748', 'cui_str': 'Harness (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0337209', 'cui_str': 'Slipping (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.123032,"Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR]=0.40, 95% confidence interval [CI]=0.22-0.76), slip falls (RR=0.33, 95% CI=0.12-0.90) and trip falls (RR=0.49, 95% CI=0.21-1.12).","[{'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daina L', 'Initials': 'DL', 'LastName': 'Sturnieks', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Brodie', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lionne', 'Initials': 'L', 'LastName': 'Duran', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Falls, Balance and Injury Research Centre, Neuroscience Research Australia, Sydney, New South Wales, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz021'] 1680,31860160,Current intensity- and polarity-specific online and aftereffects of transcranial direct current stimulation: An fMRI study.,"Transcranial direct current stimulation (tDCS) induces polarity- and dose-dependent neuroplastic aftereffects on cortical excitability and cortical activity, as demonstrated by transcranial magnetic stimulation (TMS) and functional imaging (fMRI) studies. However, lacking systematic comparative studies between stimulation-induced changes in cortical excitability obtained from TMS, and cortical neurovascular activity obtained from fMRI, prevent the extrapolation of respective physiological and mechanistic bases. We investigated polarity- and intensity-dependent effects of tDCS on cerebral blood flow (CBF) using resting-state arterial spin labeling (ASL-MRI), and compared the respective changes to TMS-induced cortical excitability (amplitudes of motor evoked potentials, MEP) in separate sessions within the same subjects (n = 29). Fifteen minutes of sham, 0.5, 1.0, 1.5, and 2.0-mA anodal or cathodal tDCS was applied over the left primary motor cortex (M1) in a randomized repeated-measure design. Time-course changes were measured before, during and intermittently up to 120-min after stimulation. ROI analyses indicated linear intensity- and polarity-dependent tDCS after-effects: all anodal-M1 intensities increased CBF under the M1 electrode, with 2.0-mA increasing CBF the greatest (15.3%) compared to sham, while all cathodal-M1 intensities decreased left M1 CBF from baseline, with 2.0-mA decreasing the greatest (-9.3%) from sham after 120-min. The spatial distribution of perfusion changes correlated with the predicted electric field, as simulated with finite element modeling. Moreover, tDCS-induced excitability changes correlated more strongly with perfusion changes in the left sensorimotor region compared to the targeted hand-knob region. Our findings reveal lasting tDCS-induced alterations in cerebral perfusion, which are dose-dependent with tDCS parameters, but only partially account for excitability changes.",2020,"ROI analyses indicated linear intensity- and polarity-dependent tDCS after-effects: all anodal-M1 intensities increased CBF under the M1 electrode, with 2.0-mA increasing CBF the greatest (15.3%) compared to sham, while all cathodal-M1 intensities decreased left M1 CBF from baseline, with 2.0-mA decreasing the greatest (-9.3%) from sham after 120-min.",['separate sessions within the same subjects (n = 29'],"['2.0-mA anodal or cathodal tDCS', 'Transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation', 'tDCS']","['cortical excitability and cortical activity', 'cerebral blood flow (CBF', 'left M1 CBF', 'tDCS-induced excitability changes', 'Time-course changes']","[{'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}]",,0.0584778,"ROI analyses indicated linear intensity- and polarity-dependent tDCS after-effects: all anodal-M1 intensities increased CBF under the M1 electrode, with 2.0-mA increasing CBF the greatest (15.3%) compared to sham, while all cathodal-M1 intensities decreased left M1 CBF from baseline, with 2.0-mA decreasing the greatest (-9.3%) from sham after 120-min.","[{'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Giorgi', 'Initials': 'G', 'LastName': 'Batsikadze', 'Affiliation': 'Department of Neurology, Essen University Hospital, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Hsiao-I', 'Initials': 'HI', 'LastName': 'Kuo', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Raf L J', 'Initials': 'RLJ', 'LastName': 'Meesen', 'Affiliation': 'REVAL Research Institute, University of Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dechent', 'Affiliation': 'Department of Cognitive Neurology, University Medical Center, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}]",Human brain mapping,['10.1002/hbm.24901'] 1681,32493256,Differences in realized access to healthcare among newly arrived refugees in Germany: results from a natural quasi-experiment.,"BACKGROUND Germany has a statutory health insurance (SHI) that covers nearly the entire population and most of the health services provided. Newly arrived refugees whose asylum claim is still being processed are initially excluded from the SHI. Instead, their entitlements are restricted and parallel access models have been implemented. We assessed differences in realized access of healthcare services between these access models. METHODS In Germany's largest federal state, North Rhine-Westphalia, two different access models have been implemented in the 396 municipalities: the healthcare voucher (HcV) model and the electronic health card (eHC) model. As refugees are quasi-randomly assigned to municipalities, we were able to realize a natural quasi-experiment including all newly assigned refugees from six municipalities (three for each model) in 2016 and 2017. Using claims data, we compared the standardized incidence rates (SIR) of specialist services use, emergency services use, and hospitalization due to ambulatory care sensitive conditions (ACSC) between both models. We indirectly standardized utilization patterns first for age and then for the sex. RESULTS SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC (ranging from 1.40 to 1.71) and differed significantly from the expected rates derived from official health reporting. SIRs of emergency and specialist use in municipalities with eHC converged with the expected rates over time. There were no significant differences in standardized hospitalization rates for ACSC. CONCLUSION The results suggest that the eHC model is slightly better able to provide refugees with SHI-like access to specialist services and goes along with lower utilization of emergency services compared to the HcV model. No difference between the models was found for hospitalizations due to ACSC. Results might be slightly biased due to incompletely documented service use and due to (self-) selection on the level of municipalities with municipalities interested in facilitating access showing more interest in joining the project.",2020,"RESULTS SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC",[],['eHC'],"['standardized incidence rates (SIR) of specialist services use, emergency services use, and hospitalization due to ambulatory care sensitive conditions (ACSC', 'standardized hospitalization rates']",[],"[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0302105,"RESULTS SIRs of emergency use were higher in municipalities with HcV (ranging from 1.41 to 2.63) compared to emergency rates in municipalities with eHC","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wenner', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany. judith.wenner@uni-bielefeld.de.'}, {'ForeName': 'Kayvan', 'Initials': 'K', 'LastName': 'Bozorgmehr', 'Affiliation': 'Department of Population Medicine and Health Services Research, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Duwendag', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rolke', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Razum', 'Affiliation': 'Department of Epidemiology & International Public Health, School of Public Health, Bielefeld University, P.O. Box 10 01 31, 33501, Bielefeld, Germany.'}]",BMC public health,['10.1186/s12889-020-08981-2'] 1682,32493267,Effectiveness of a progressive resistance exercise program for industrial workers during breaks on perceived fatigue control: a cluster randomized controlled trial.,"BACKGROUND There is strong evidence that physical exercise in the workplace is effective for reducing workers' musculoskeletal complaints. Studies with industrial workers and studies on progressive resistance exercises during breaks are scarce. Our aim was to evaluate the effects of a resistance exercise program on perceived fatigue control among industrial workers. METHODS 204 employees from the dairy industry were allocated to two groups, the intervention group (IG) (n = 98) and the control group (CG) (n = 106). The primary outcome measures were perceived fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM), respectively. Secondary outcome measures were musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity. All outcomes were assessed at baseline and then again after 4 months. The IG performed resistance exercises using progressively greater loads while the CG performed general exercise using elastic bands. The exercise protocols were performed three times per week for 20 min. An intention-to-treat analysis was performed using the mixed linear model. Results were considered significant when p < 0.05. RESULTS The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace. There was also no significant difference between the groups for musculoskeletal complaints and other secondary variables analyzed. However, both groups showed significant improvements between baseline and after 4 months of intervention for all evaluated outcomes (p < 0.05). CONCLUSION The implementation of a progressive resistance exercise program during work breaks for perceived fatigue control was no more effective than exercises using elastic bands. However, resistance exercises during work breaks presented better results on all measured outcomes regardless of the exercise protocol used. TRIAL REGISTRATION U.S. National Institutes of Health, ClinicalTrials.gov Identifier: NCT02172053. Registered 19 June 2014.",2020,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[""workers' musculoskeletal complaints"", 'industrial workers during breaks on perceived fatigue control', 'industrial workers', '204 employees from the dairy industry']","['control group (CG', 'resistance exercise program', 'progressive resistance exercise program', 'physical exercise']","['fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one-repetition maximum contraction (1-RM', 'musculoskeletal complaints', 'fatigue control and muscle strength', 'progressive resistance exercises', 'musculoskeletal complaints, physical activity level, perceived risk factors, physical fitness (BMI, vital signs, and body fat percentage), and workers´ productivity']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4279966', 'cui_str': 'Dairy Industry'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",204.0,0.0894599,"The IG did not show to be superior to the CG, although both groups improved perceived fatigue control and muscle strength after the resistance physical exercise program in the worplace.","[{'ForeName': 'Hélio Gustavo', 'Initials': 'HG', 'LastName': 'Santos', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Luciana Dias', 'Initials': 'LD', 'LastName': 'Chiavegato', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Daniela Pereira', 'Initials': 'DP', 'LastName': 'Valentim', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Rosimeire Simprini', 'Initials': 'RS', 'LastName': 'Padula', 'Affiliation': 'Master and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), Rua Cesário Galeno, 448/475 Tatuapé, São Paulo, 03071-000, Brazil. rosimeire.padula@unicid.edu.br.'}]",BMC public health,['10.1186/s12889-020-08994-x'] 1683,32493318,Impact of take-home messages written into slide presentations delivered during lectures on the retention of messages and the residents' knowledge: a randomized controlled study.,"BACKGROUND Lectures with slide presentations are widely used to teach evidence-based medicine to large groups. Take-home messages (THMs) are poorly identified and recollected by students. We investigated whether an instruction to list THMs in written form on slides would improve the retention thereof by residents, and the residents' level of knowledge, 1 month after lectures. METHODS Prospective blinded randomized controlled study was conducted. Twelve lectures (6 control and 6 intervention lectures) were delivered to 73 residents. For the intervention lectures, the lecturers were instructed to incorporate clear written THMs into their slide presentations. The outcomes were ability of resident to recollect THMs delivered during a lecture (as assessed by accordance rate between the lecturers' and residents' THMs) and knowledge (as assessed by multiple choice questions (MCQs)). RESULTS Data for 3738 residents' THMs and 3410 MCQs were analyzed. The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75). In multivariable analyses performed with all THMs written on slides from the two groups, a superior knowledge was associated with notetaking during lectures (OR 1.88, 95% CI 1.41-2.51) and THMs retention (OR 2.17, 95% CI 1.54-3.04); and THMs retention was associated with written THMs (OR 2.94, 95% CI 2.20-3.93). CONCLUSIONS In lectures delivered to residents, a third of the THMs were not in written form. An intervention based on an explicit instruction to lecturers to provide THMs in written form in their slide presentations did not result in increased use of written THMs into the slide presentation or improvement of the THMs retention or level of knowledge. However, we showed that there was a strong positive association between writing THMs on a slide, retention of THMs and residents' knowledge. Further researches are needed to assess interventions to increase written THMs in lectures by faculty. TRIAL REGISTRATION ClinicalTrials.gov NCT01795651 (Fev 21, 2013).",2020,"The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75).","[""3738 residents' THMs and 3410 MCQs""]",[],"['THMs retention or level of knowledge', 'THMs retention', ""ability of resident to recollect THMs delivered during a lecture (as assessed by accordance rate between the lecturers' and residents' THMs) and knowledge (as assessed by multiple choice questions (MCQs"", 'number of THMs written on slides']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}]",,0.0987876,"The intervention did not significantly increase the number of THMs written on slides (77% (n = 20/26), 95% CI 56-91 vs 64% (n = 18/28), 95% CI 44-81, p = 0.31) nor THMs retention (13% (n = 238/1791), 95% CI 12-15 vs 17% (n = 326/1947), 95% 15-18, p = 0.40) nor knowledge (63.8 ± 26.2 vs 61.1 ± 31.4 /100 points, p = 0.75).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Intensive Care Medicine, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. alautrette@chu-clermontferrand.fr.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Boyer', 'Affiliation': 'Intensive Care Unit, Pellegrin-Tripode Hospital, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Gruson', 'Affiliation': 'Intensive Care Unit, Pellegrin-Tripode Hospital, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Argaud', 'Affiliation': 'Intensive Care Unit, Edouard Herriot Hospital, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Schwebel', 'Affiliation': 'Intensive Care Unit, Albert Michallon Hospital, University Hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Tardy', 'Affiliation': 'Clinical Investigation Center-CIC 1408, Nord Teaching Hospital, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vignon', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Dupuytren Hospital, University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'Department of Medical and Toxicological Critical Care, Lariboisière Hospital, Assistance Publique - Hopitaux de Paris, INSERM UMRS-1144, Paris-Diderot University, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Schoeffler', 'Affiliation': 'Intensive Care Unit, Department of Anaesthesiology, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chabrot', 'Affiliation': 'Department of Radiology, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jeannot', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Adult Emergency Department, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Nutrition Unit, Gabriel Montpied Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Guerin', 'Affiliation': 'Intensive Care Unit, Croix Rousse Hospital, University Hospital of Lyon, Lyon, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Darmon', 'Affiliation': 'Intensive Care Unit, Nord Teaching Hospital, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Intensive Care Unit, Lapeyronie Hospital, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'LMGE «Laboratoire Micro-organismes: Génome et Environnement», UMR CNRS 6023, Clermont-Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Intensive Care Unit, l'Archet Hospital, Cote d'Azur University, Nice, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics unit, Delegation à la Recherche Clinique (DRCI), University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medical education,['10.1186/s12909-020-02092-7'] 1684,31985516,Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial.,"PURPOSE NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data. METHODS Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm-6 cycles of gemcitabine. Gemcitabine+erlotinib arm-gemcitabine and erlotinib 100 mg/d. Two hundred deaths provided 90% power (1-sided α=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2. RESULTS From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ≤90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38). CONCLUSIONS The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.",2020,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","['Resected Cancer of the Pancreatic Head', 'From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2', 'Median age was 63 (39 to 86) years', 'patients with resected pancreatic head adenocarcinoma', 'Eligibility-within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180']","['Gemcitabine', 'fluoropyrimidine', 'gemcitabine and erlotinib', 'Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine', 'gemcitabine-based adjuvant chemotherapy', 'gemcitabine', 'Gemcitabine+erlotinib arm-gemcitabine and erlotinib']","['median and 3-year OS', 'survival', 'Hazard ratio', 'hypothesized OS signal']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",163.0,0.114886,"GI adverse events, arm 1: 22% grade ≥3 and arm 2: 28%, (P=0.22).","[{'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Abrams', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Winter', 'Affiliation': 'NRG Oncology Statistics and Data Management Center.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital.'}, {'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Goodman', 'Affiliation': 'University of Colorado Cancer Center, Denver, CO.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Regine', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Berger', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Gillin', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Lowy', 'Affiliation': 'UC San Diego Moores Cancer Center, San Diego.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'DiPetrillo', 'Affiliation': 'Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Corn', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Seaward', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Haddock', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Suisui', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'USC/Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, MD.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Fisher', 'Affiliation': 'London Regional Cancer Program, London, ON, Canada.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Katz', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Spartanburg Regional Medical Center, Spartanburg, SC.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Willett', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Crane', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000633'] 1685,31746766,An Interactive Mobile Phone App (SMART 5-A-DAY) for Increasing Knowledge of and Adherence to Fruit and Vegetable Recommendations: Development and Pilot Randomized Controlled Trial.,"BACKGROUND Fruit and vegetable consumption is important for health, but many individuals fail to consume adequate amounts for health benefits. Although many individuals are aware of current fruit and vegetable consumption recommendations, research suggests that adherence to these is hampered by low knowledge of the details of these recommendations. OBJECTIVE This paper reports the development and details of a pilot randomized controlled test of a novel interactive mobile phone app for addressing low knowledge of the UK 5-a-day fruit and vegetable recommendations. METHODS Requirements for the app were first defined by researchers and potential end users and prioritized using the MoSCoW (Must have, Should have, Could have, Won't have) method. Second, a prototype mobile phone app was developed using an agile approach. Third, the prototype app was tested in a randomized controlled pilot trial for impacts on knowledge and intake of fruit and vegetables. Volunteers were randomized to either receive (n=50) or not receive the app (n=44) for 2 or 4 weeks, and fruit and vegetable knowledge, intake, and behavior were assessed at the beginning of the study and after 1 and 2 weeks or after 2 and 4 weeks, respectively. App usage and qualitative feedback were also investigated. All findings then informed the development of a final app. RESULTS Low knowledge of consumption recommendations centered around portion sizes and the need for variety, and an interactive mobile phone app was considered a suitable tool for improving this knowledge in a practical manner that would be available both at time of consumption and outside of these times. The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures. Patterns of app usage and qualitative feedback also suggested a number of modifications. The resultant final app incorporates several behavior change techniques (goal-setting, self-monitoring, and personalized feedback) as well as aiming to improve knowledge. CONCLUSIONS A novel interactive mobile phone app was successfully developed based on requirements, and when tested in a pilot randomized controlled trial, this app was found to have some impacts on fruit and vegetable outcomes. Although benefits from the app were small, impacts will likely increase as a result of recent modifications. The final SMART 5-A-DAY app is available in the Google Play Store and now needs testing in the target population. TRIAL REGISTRATION ClinicalTrials.gov NCT02779491; https://www.clinicaltrials.gov/ct2/show/NCT02779491.",2019,"The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures.",[],"['MoSCoW', 'Interactive Mobile Phone App (SMART 5-A-DAY', 'fruit and vegetables']","['fruit and vegetable intakes', 'knowledge on fruit and vegetable recommendations']",[],"[{'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0717954,"The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures.","[{'ForeName': 'Katherine Marie', 'Initials': 'KM', 'LastName': 'Appleton', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Passmore', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Burn', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Pidgeon', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Nation', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boobyer', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14380'] 1686,31504699,"Prevotella Abundance Predicts Weight Loss Success in Healthy, Overweight Adults Consuming a Whole-Grain Diet Ad Libitum: A Post Hoc Analysis of a 6-Wk Randomized Controlled Trial.","BACKGROUND The key to effective weight loss may be to match diet and gut microbes, since recent studies have found that subjects with high Prevotella abundances in their gut microbiota lose more weight on diets rich in fiber than subjects with low Prevotella abundances. OBJECTIVES We reanalyzed a 6-wk, parallel, randomized trial to investigate difference in body weight changes when participants, stratified by fecal microbiota composition, consumed ad libitum a whole-grain (WG) or a refined-wheat (RW) diet. METHODS We stratified 46 (19 men, 27 women; ages 30-65 y) healthy, overweight adults by baseline Prevotella-to-Bacteroides ratios and Prevotella abundances. Subjects with no Prevotella were analyzed separately (n = 24). Compared with the RW diet (mean = 221 g/d), the WG diet (mean = 228 g/d) had a higher fiber content (33 g/d compared with 23 g/d). Linear mixed models and correlations were applied to link 6-wk changes in body weights and metabolic and microbiota markers, according to Prevotella groups and diets. RESULTS The Prevotella abundances correlated inversely with weight changes (r = -0.34; P = 0.043). Consequently, subjects with high Prevotella abundances (n = 15) spontaneously lost 1.80 kg (95% CI: -3.23, -0.37 kg; P = 0.013) more on the WG diet than on the RW diet, whereas those with low Prevotella abundances (n = 31) were weight stable (-0.22 kg; 95% CI: -1.40, 0.96 kg; P = 0.72). Thus, the mean difference between the Prevotella groups was 2.02 kg (95% CI: -3.87, -0.17 kg; P = 0.032). Subjects with no Prevotella lost 1.59 kg (95% CI: -2.65, -0.52 kg; P = 0.004) more on the WG diet than on the RW diet. No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups. CONCLUSIONS Healthy, overweight adults with high Prevotella abundances lost more weight than subjects with low Prevotella abundances when consuming a diet rich in WG and fiber ad libitum for 6 wk. This further supports enterotypes as a potential biomarker in personalized nutrition for obesity management. This t rial was registered at clinicaltrials.gov as NCT02358122.",2019,"No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups. ","['Healthy, Overweight Adults', 'Healthy, overweight adults with high Prevotella abundances lost more weight than subjects with low Prevotella abundances', 'We stratified 46 (19 men, 27 women; ages 30-65 y) healthy, overweight adults by baseline Prevotella-to-Bacteroides ratios and Prevotella abundances', 'Subjects with no Prevotella were analyzed separately (n\xa0=\xa024']",['ad libitum a whole-grain (WG) or a refined-wheat (RW) diet'],"['weight stable', 'body weight changes', 'appetite sensations, glucose metabolisms, or fecal SCFAs', 'body weights and metabolic and microbiota markers', 'weight changes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",27.0,0.0566069,"No 6-wk changes in appetite sensations, glucose metabolisms, or fecal SCFAs were associated with the Prevotella groups. ","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Vuholm', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Krych', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kristensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Denmark.'}]",The Journal of nutrition,['10.1093/jn/nxz198'] 1687,31925414,Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes.,"BACKGROUND Self-management of symptoms related to cancer and its treatment is important for maintaining treatment regimens and improving outcomes. PURPOSE To determine factors associated with engagement in a symptom self-management intervention among patients initiating oral anticancer treatment. METHODS This secondary analysis included 127 patients randomized to the medication adherence reminder and symptom management intervention in a recently completed trial. Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms. During eight automated telephone weekly calls, patients were asked to use the Toolkit to manage elevated symptoms. Toolkit use and symptoms were tracked weekly, and generalized linear mixed-effects models were used to determine factors predictive of Toolkit use. General linear modeling was used to relate the Toolkit use during intervention to postintervention symptom severity. RESULTS Better cognitive function at intake into the trial and higher symptom burden were predictive of the patients' initial decision to try the Toolkit during Week 1. In subsequent weeks, Toolkit use in the previous week and worsening of symptoms were associated with greater odds of Toolkit use. The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks. CONCLUSIONS Patients make realistic decisions regarding when to use a self-directed approach to self-management and are likely to use strategies when their symptoms are higher and to forego use once symptoms subside. CLINICAL TRIAL REGISTRATION NCT02043184.",2020,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks. ","['patients with higher levels of severity at intake', '127 patients randomized to the', 'patients initiating oral anticancer treatment', 'Patients were recruited from six Comprehensive Cancer Centers, interviewed at intake, and mailed a Symptom Management Toolkit (Toolkit) with self-care management strategies for 18 symptoms']","['Automated Telephone Symptom Management Intervention', 'medication adherence reminder and symptom management intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",[],127.0,0.0266875,"The extent of Toolkit use modified the relationship between intake and 8 week symptom severity: among patients with higher levels of severity at intake, use of the Toolkit conferred greater benefit at 8 weeks. ","[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry and Department of Statistics and Probability, Michigan, State University, East Lansing, MI, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Banik', 'Affiliation': 'Department of Statistics and Probability, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Krauss', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz067'] 1688,32493248,Prophylactic intra-aortic balloon pump in patients with left main disease undergoing off-pump coronary artery bypass grafting.,"BACKGROUND Preventive intra-aortic balloon pump (IABP) for high-risk patients with stable hemodynamics is controversial, and its definition of high-risk is still unclear. This study aimed to investigate the effect of prophylactic IABP on the early outcome of left main disease (LMD) patients receiving off-pump coronary artery bypass grafting (OPCABG) with stable hemodynamics. METHODS From January 2013 to April 2020, 257 consecutive patients who underwent OPCABG through sternotomy were enrolled in this study. All LMD patients (greater than 70%) had stable hemodynamics (BP>100 mmHg without vasoconstrictor substance infusion). Early outcomes of 125 patients with prophylactic IABP (IABP group) and 132 patients without IABP (Control group) were compared in this study. RESULTS IABP did not show favorable effect on the conversion to CPB (RR 0.63, 95%CI 0.05-7.89, P = 0.7211), perioperative MI (RR 0.69, 95%CI 0.22-2.12, P = 0.5163), mortality (RR 0.65, 95%CI 0.04-10.25, P = 0.7608) or the composite end of the conversion, MI and mortality (RR 0.63, 95%CI 0.23-1.74, P = 0.3747). There was greater incidence of prolonged ventilation in IABP after adjustment (RR2.16, 95%CI 1.12-4.18, P = 0.0221). There was no IABP-related mortality or limb ischemia. CONCLUSION No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group. Prophylactic IABP may be unnecessary in patients with LMD undergoing OPCABG.",2020,No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group.,"['left main disease (LMD) patients receiving off-pump coronary artery bypass grafting (OPCABG) with stable hemodynamics', 'high-risk patients with stable hemodynamics', '125 patients with prophylactic IABP (IABP group) and 132 patients without IABP (Control group', 'From January 2013 to April 2020, 257 consecutive patients who underwent OPCABG through sternotomy were enrolled in this study', 'patients with left main disease undergoing off-pump coronary artery bypass grafting', 'patients with LMD undergoing OPCABG']","['Prophylactic intra-aortic balloon pump', 'prophylactic IABP', 'Preventive intra-aortic balloon pump (IABP', 'Prophylactic IABP']","['stable hemodynamics', 'conversion, MI and mortality', 'mortality', 'IABP-related mortality or limb ischemia', 'prolonged ventilation in IABP', 'conversion to CPB', 'perioperative MI']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",257.0,0.109726,No significant difference in early outcomes was observed in hemodynamically stable patients with LMD between prophylactic IABP group and control group.,"[{'ForeName': 'Ju-Bing', 'Initials': 'JB', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Shao-You', 'Initials': 'SY', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Shi-Jun', 'Initials': 'SJ', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Juan-Juan', 'Initials': 'JJ', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Street, Chaoyang District, Beijing, 100029, China. dongran6618@126.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01554-6'] 1689,16388054,Do shock absorbing insoles in recruits undertaking high levels of physical activity reduce lower limb injury? A randomized controlled trial.,"OBJECTIVES To assess the benefits, if any, of the use of shock absorbing insoles in reducing lower limb injury among Air Force recruits, and to assess the differences, if any, in the efficacy of two commonly available shock absorbing insoles. DESIGN Randomized controlled trial. SETTING RAF Halton, UK. Site of all basic training for RAF personnel. PARTICIPANTS 1205 recruits participating in basic training between 17 September 2003 and 7 April 2004. INTERVENTIONS Participants were randomized to receive either standard issue Saran non-shock absorbing insoles, or shock absorbing Sorbothane or Poron insoles, on a 1:1:1 basis. MAIN OUTCOME MEASURES The primary outcome measure was withdrawal from training for lower limb injury. The two primary comparisons were shock absorbing insole versus non-shock absorbing insole, and Sorbothane versus Poron (comparison of different shock absorbing insoles). Secondary outcomes were medical withdrawals for reasons other than those qualifying for the primary outcome measure. RESULTS When comparing the non-shock absorbing insole to the shock absorbing insoles 72/401 participants (18.0%) allocated to Saran insoles were removed from training because of a qualifying lower limb injury, compared with 149/804 (18.5%) allocated to the shock absorbing insole (Sorbothane or Poron), odds ratio 1.04 (95% CI 0.75 to 1.44; P=0.87). When comparing the two shock absorbing insole 73/421 participants (17.3%) randomized to Sorbothane were removed from training because of a qualifying lower limb injury, compared with 76/383 for Poron (19.8%), odds ratio 0.85 (95% CI 0.58 to 1.23; P=0.37). CONCLUSIONS Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial. The trial provides no support for a change in policy to the use of shock absorbing insoles for military recruits.",2006,"CONCLUSIONS Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial.",['1205 recruits participating in basic training between 17 September 2003 and 7 April 2004'],"['standard issue Saran non-shock absorbing insoles, or shock absorbing Sorbothane or Poron insoles']","['lower limb injuries', 'shock absorbing insole versus non-shock absorbing insole, and Sorbothane versus Poron', 'withdrawal from training for lower limb injury', 'medical withdrawals for reasons']","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0074048', 'cui_str': 'Saran'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0074921', 'cui_str': 'sorbothane'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0074921', 'cui_str': 'sorbothane'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",,0.251835,"CONCLUSIONS Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Withnall', 'Affiliation': 'Regional Medical Centre & Regional Rehabilitation Unit, RAF Halton, Aylesbury, Bucks HP22 5PG, UK. richwithnall@doctors.org.uk'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Eastaugh', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1690,31510777,Dynamic Changes in the Molecular Signature of Adverse Left Ventricular Remodeling in Patients With Compensated and Decompensated Chronic Primary Mitral Regurgitation.,"BACKGROUND There is no proven medical therapy that attenuates adverse left ventricular remodeling in patients with chronic primary mitral regurgitation (CPMR). Identification of molecular pathways important in the progression of left ventricular remodeling in patients with CPMR may lead to development of new therapeutic strategies. METHODS AND RESULTS We performed baseline echocardiographic, cardiac catheterization, and serum NT-pro-BNP analysis in patients with severe CPMR awaiting mitral valve surgery and stratified the study population into compensated or decompensated CPMR. We obtained left ventricular endomyocardial biopsies (n=12) for mRNA expression analysis, and compared baseline transcript levels of 109 genes important in volume-overload left ventricular remodeling with levels in normal hearts (n=5) and between patients with compensated (n=6) versus decompensated (n=6) CPMR. Patients were then randomized to treatment with and without carvedilol and followed until the time of surgery (mean follow-up 8.3 months) when repeat endomyocardial biopsies were obtained to correlate transcriptional dynamics with indices of adverse remodeling. CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes. Decompensated CPMR was associated with downregulation of SERCA2 (0.77-fold, P =0.009) and mitochondrial gene expression levels and upregulation of genes related to inflammation, the extracellular matrix, and apoptosis, which were refractory to carvedilol therapy. CONCLUSIONS Transition to decompensated CPMR is associated with calcium dysregulation, increased expression of inflammatory, extracellular matrix and apoptotic genes, and downregulation of genes important in bioenergetics. These changes are not attenuated by carvedilol therapy and highlight the need for development of specific combinatorial therapies, targeting myocardial inflammation and apoptosis, together with urgent surgical or percutaneous valve interventions.",2019,"CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes.","['patients with chronic primary mitral regurgitation (CPMR', 'Patients With Compensated and Decompensated Chronic Primary Mitral Regurgitation', 'patients with severe CPMR awaiting mitral valve surgery and stratified the study population into compensated or decompensated CPMR', 'patients with CPMR', 'normal hearts (n=5) and between patients with compensated (n=6) versus decompensated (n=6) CPMR']",['carvedilol'],"['NPPA expression levels', 'decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026264', 'cui_str': 'Bicuspid Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}]","[{'cui': 'C0068273', 'cui_str': 'NPPA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0015350', 'cui_str': 'Extracellular Matrix'}]",,0.0290515,"CPMR was associated with increased NPPA expression levels (21.6-fold, P =0.004), decreased transcripts of genes important in cell survival, and enrichment of extracellular matrix genes.","[{'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'McCutcheon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'van Pelt', 'Affiliation': 'Department of Clinical Digestive Oncology, Faculty of Medicine, Katholieke Universiteit, Leuven and Leuven Cancer Institute, Leuven, Belgium (J.v.P.).'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Dix-Peek', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Grinter', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Atulkumar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiothoracic Surgery (A.P.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Department of Anatomical Pathology (M.H.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nqoba', 'Initials': 'N', 'LastName': 'Tsabedze', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Vachiat', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Zachariah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Duarte', 'Affiliation': 'Molecular Biology Laboratory, Department of Internal Medicine (C.D., T.D.-P., R.D.), University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., S.J.).'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Manga', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (K.M., S.G., L.M., N.T., A.V., D.Z., P.M.), Charlotte Maxeke Johannesburg Academic Hospital & University of the Witwatersrand, Johannesburg, South Africa.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.005974'] 1691,30883357,Rationale and Design of a Clinical Trial of Adapted Tango to Improve Negative Health Impacts in Middle Aged African-American Female Caregivers of Persons with Alzheimer's Disease (ACT Trial).,"Alzheimer's disease (AD) is a devastating progressive neurodegenerative disease resulting in memory loss and a severe reduction in ability to perform activities of daily living. The role of caring for someone with AD frequently falls to female family members, often daughters. The burden of caregiving can increase stress and anxiety and cause health decline in the caregiver. The combination of ethnicity-related genetic factors promoting the development of dementias among African-Americans (AA) and the increased risk among women for developing AD means that AA women who are caregivers of a parent with AD are at great risk for developing dementias including AD. The proposed study would compare the cognitive, motor, and psychosocial benefits of a well-established 12 week, 20-lesson adapted Argentine Tango intervention (N = 30) to a no-contact control group (N = 10) in middle-aged (45-65 years) AA women who are caregivers of a parent with AD in the metro Atlanta area.",2019,The combination of ethnicity-related genetic factors promoting the development of dementias among African-Americans (AA) and the increased risk among women for developing AD means that AA women who are caregivers of a parent with AD are at great risk for developing dementias including AD.,"[""Alzheimer's disease (AD"", ""Middle Aged African-American Female Caregivers of Persons with Alzheimer's Disease (ACT Trial"", 'AA women who are caregivers of a parent with AD in the metro Atlanta area', 'group (N\u200a=\u200a10) in middle-aged (45-65 years']","['20-lesson adapted Argentine Tango intervention', 'no-contact control']",['Negative Health Impacts'],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0430654,The combination of ethnicity-related genetic factors promoting the development of dementias among African-Americans (AA) and the increased risk among women for developing AD means that AA women who are caregivers of a parent with AD are at great risk for developing dementias including AD.,"[{'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Hackney', 'Affiliation': 'Department of Medicine, Division of General Medicine and Geriatrics, Emory School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'McCullough', 'Affiliation': 'Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Bay', 'Affiliation': 'Department of Medicine, Division of General Medicine and Geriatrics, Emory School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Hayley A', 'Initials': 'HA', 'LastName': 'Silverstein', 'Affiliation': 'Department of Medicine, Division of General Medicine and Geriatrics, Emory School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ariel R', 'Initials': 'AR', 'LastName': 'Hart', 'Affiliation': 'Department of Medicine, Division of General Medicine and Geriatrics, Emory School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Shin', 'Affiliation': 'Emory University College of Arts and Sciences, Atlanta, GA, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Wharton', 'Affiliation': 'Department of Neurology, Atlanta, Emory University School of Medicine, GA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181130'] 1692,31473505,A diet of U.S. military food rations alters gut microbiota composition and does not increase intestinal permeability.,"Interactions between gut microbes and dietary components modulate intestinal permeability (IP) and inflammation. Recent studies have reported altered fecal microbiota composition together with increased IP and inflammation in individuals consuming military food rations in austere environments, but could not isolate effects of the diet from environmental factors. To determine how the U.S. Meal, Ready-to-Eat food ration affects fecal microbiota composition, IP and inflammation, 60 adults (95% male,18-61 years) were randomized to consume their usual ad libitum diet for 31 days (CON) or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE). In both groups, fecal microbiota composition was measured before, during (INT, days 1-21) and after the intervention period. IP and inflammation [high-sensitivity C-reactive protein (hsCRP)] were measured on days 0, 10, 21 and 31. Longitudinal changes in fecal microbiota composition differed between groups (P=.005), and fecal samples collected from MRE during INT were identified with 88% accuracy using random forest models. The genera making the strongest contribution to that prediction accuracy included multiple lactic acid bacteria (Lactobacillus, Lactococcus, Leuconostoc), which demonstrated lower relative abundance in MRE, and several genera known to dominate the ileal microbiota (Streptococcus, Veillonella, Clostridium), the latter two demonstrating higher relative abundance in MRE. IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise. Findings demonstrate that a Meal, Ready-to-Eat ration diet alters fecal microbiota composition and does not increase IP or inflammation.",2019,"IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise.","['60 adults (95% male,18-61 years']","['IP and inflammation [high-sensitivity C-reactive protein (hsCRP', 'consume their usual ad libitum diet for 31 days (CON) or a strictly controlled Meal, Ready-to-Eat-only diet for 21 days followed by their usual diet for 10 days (MRE']","['intestinal permeability', 'IP or inflammation', 'fecal microbiota composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",60.0,0.0290759,"IP and hsCRP were both lower (34% and 41%, respectively) in MRE relative to CON on day 21 (P<.05) but did not differ otherwise.","[{'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: James.p.karl.civ@mail.mil.'}, {'ForeName': 'Nicholes J', 'Initials': 'NJ', 'LastName': 'Armstrong', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: Nicholes.j.armstrong.civ@mail.mil.'}, {'ForeName': 'Holly L', 'Initials': 'HL', 'LastName': 'McClung', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: holly.l.mcclung.civ@mail.mil.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Player', 'Affiliation': 'Johns Hopkins University Applied Physics Laboratory, 11100 Johns Hopkins Rd, Laurel, MD 20723, USA. Electronic address: Robert.player@jhuapl.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, USA. Electronic address: Jennifer.rood@pbrc.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Racicot', 'Affiliation': 'Combat Feeding Directorate, U.S. Army Combat Capabilities Development Command-Soldier Center, 15 General Greene Ave, Natick, MA 01760, USA. Electronic address: Kenneth.racicot.civ@mail.mil.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Soares', 'Affiliation': 'Soldier Performance Optimization Directorate, U.S. Army Combat Capabilities Development Command-Soldier Center, 15 General Greene Ave, Natick, MA 01760, USA. Electronic address: Jason.w.soares.civ@mail.mil.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': 'Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine, 10 General Greene Ave, Natick, MA 01760, USA. Electronic address: scott.j.montain.civ@mail.mil.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.108217'] 1693,31504868,Acute Experimental Pain Responses in Methadone- and Buprenorphine/Naloxone-Maintained Patients Administered Additional Opioid or Gabapentin: A Double-Blind Crossover Pilot Study.,"OBJECTIVE The study objective was to identify the analgesic efficacy of three different pharmacological strategies in patients receiving methadone or buprenorphine as opioid agonist treatment (OAT). The three pharmacological approaches, a) increasing maintenance methadone/buprenorphine dose by 30%, b) adding oxycodone, or c) adding a single dose of gabapentin, were compared with a control condition of the participant's usual OAT dose. DESIGN A randomized, controlled, double-blinded, double-dummy, within-subject crossover study. SUBJECTS Nine participants on stable doses of methadone and eight participants on stable doses of buprenorphine were recruited. SETTING An outpatient opioid treatment clinic in inner city Sydney, Australia. METHODS The cold pressor tolerance test was used to examine experimental pain threshold and tolerance. Ratings of subjective drug effects and safety measures (physiological and cognitive) were assessed. RESULTS There was no difference in the primary outcome measures of pain thresholds or tolerance between the conditions examined. Interindividual variability was evident. Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition. In the buprenorphine arm, increased drug liking and ""bad effects"" were detected with oxycodone administration, while increased subjective intoxication was identified with gabapentin. CONCLUSIONS There was no evidence of an objective improvement in analgesia with any condition compared with control. Further research is required to optimize pain management strategies in this population.",2020,"Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition.","['patients receiving methadone or buprenorphine as opioid agonist treatment (OAT', 'Nine participants on stable doses of methadone and eight participants on stable doses of', 'An outpatient opioid treatment clinic in inner city Sydney, Australia']","['methadone/buprenorphine', 'oxycodone, or c) adding a single dose of gabapentin', 'Methadone- and Buprenorphine/Naloxone-Maintained Patients Administered Additional Opioid or Gabapentin', 'buprenorphine', 'oxycodone']","['analgesic efficacy', 'Ratings of subjective drug effects and safety measures (physiological and cognitive', 'Acute Experimental Pain Responses', 'lower pain recall, lower ""bad effects,"" and higher global satisfaction', 'pain thresholds or tolerance', 'drug liking and ""bad effects', 'Interindividual variability', 'subjective intoxication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557849', 'cui_str': 'Inner city environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]",9.0,0.341347,"Differences in some subjective measures were identified, including lower pain recall, lower ""bad effects,"" and higher global satisfaction in the additional methadone condition.","[{'ForeName': 'Bridin Patricia', 'Initials': 'BP', 'LastName': 'Murnion', 'Affiliation': 'Drug and Alcohol Services, Central Coast Local Health District, Hamlyn Terrace, Australia.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Apo', 'Initials': 'A', 'LastName': 'Demirkol', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Hayes', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz178'] 1694,15083524,Enhancement of GABA-related signalling is associated with increase of functional connectivity in human cortex.,"Structural or operational synchrony analysis with EEG was conducted in order to detect functional interaction between cortical areas during an enhanced inhibition induced by the GABAergic agonist lorazepam in a double-blind, randomized, placebo-controlled, cross-over study in eight healthy human subjects. Specifically, we investigated whether a neuronal inhibitory system in the brain mediates functional decoupling of cortical areas. Single-dose lorazepam administration resulted in a widespread increase in the inter-area functional connectivity and an increase in the strength of functional long-range and interhemispheric connections. These results suggest that inhibition can be an efficient mechanism for synchronization of large neuronal populations.",2004,Single-dose lorazepam administration resulted in a widespread increase in the inter-area functional connectivity and an increase in the strength of functional long-range and interhemispheric connections.,['eight healthy human subjects'],"['lorazepam', 'placebo', 'GABAergic agonist lorazepam']","['strength of functional long-range and interhemispheric connections', 'inter-area functional connectivity']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",8.0,0.149858,Single-dose lorazepam administration resulted in a widespread increase in the inter-area functional connectivity and an increase in the strength of functional long-range and interhemispheric connections.,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science Brain & Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': ''}, {'ForeName': 'Reetta', 'Initials': 'R', 'LastName': 'Kivisaari', 'Affiliation': ''}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pekkonen', 'Affiliation': ''}, {'ForeName': 'Risto J', 'Initials': 'RJ', 'LastName': 'Ilmoniemi', 'Affiliation': ''}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Kähkönen', 'Affiliation': ''}]",Human brain mapping,[] 1695,31515355,"Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study.","Data on the impact of long term treatment with immunomodulatory drugs (IMiD) on health-related quality of life (HRQoL) is limited. The HOVON-87/NMSG18 study was a randomized, phase 3 study in newly diagnosed transplant ineligible patients with multiple myeloma, comparing melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R). The EORTC QLQ-C30 and MY20 questionnaires were completed at baseline, after three and nine induction cycles and six and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in HRQoL reporting. Patients reported clinically relevant improvement in global quality of life (QoL), future perspective and role and emotional functioning, and less fatigue and pain in both arms. The latter being of large effect size. In general, improvement occurred after 6-12 months of maintenance only and was independent of the World Health Organisation performance at baseline. Patients treated with MPR-R reported clinically relevant worsening of diarrhea, and patients treated with MPT-T reported a higher incidence of neuropathy. Patients who remained on lenalidomide maintenance therapy for at least three months reported clinically meaningful improvement in global QoL and role functioning at six months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, HRQoL improves both during induction and maintenance therapy with immunomodulatory drugs. The side effect profile of treatment did not negatively affect global QoL, but it was, however, clinically relevant for the patients. ( Clinicaltrials.gov identifier: NTR1630 ).",2020,"Patients reported clinically relevant improvement in global quality of life, future perspective and role and emotional functioning, and less fatigue and pain in both arms.","['596 patients participated in health-related quality of life reporting', 'newly diagnosed transplant ineligible patients with multiple myeloma, comparing', 'transplant ineligible newly diagnosed multiple myeloma patients treated with either']","['melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R', 'thalidomide or lenalidomide', 'thalidomide']","['global quality of life', 'global QoL and role functioning', 'global quality of life, future perspective and role and emotional functioning, and less fatigue and pain', 'neuropathy', 'diarrhea', 'Health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",596.0,0.0684156,"Patients reported clinically relevant improvement in global quality of life, future perspective and role and emotional functioning, and less fatigue and pain in both arms.","[{'ForeName': 'Lene Kongsgaard', 'Initials': 'LK', 'LastName': 'Nielsen', 'Affiliation': 'Quality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark lene.kongsgaard.nielsen@rsyd.dk.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Stege', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam, the Netherlands.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Section of Hematology and Coagulation, Department of Medicine, Sahlgrenska University Hospital, Gotheborg, Sweden.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Salomo', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bos', 'Affiliation': 'Department of Haematology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Visser-Wisselaar', 'Affiliation': 'HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hansson', 'Affiliation': 'Department of Haematology and Wallenberg Center for Molecular Medicine, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Velden', 'Affiliation': 'Department of Internal Medicine, Martini Ziekenhuis, Groningen, the Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Deenik', 'Affiliation': 'Department of Internal Medicine, Tergooi Ziekenhuis, Hilversum, the Netherlands.'}, {'ForeName': 'Juleon', 'Initials': 'J', 'LastName': 'Coenen', 'Affiliation': 'Department of Internal Medicine, Isala, Zwolle, the Netherlands.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hinge', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Vejle Hospital, Vejle, Denmark.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Department of Internal Medicine, Meander Medisch Centrum, Amersfoort, the Netherlands.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Tanis', 'Affiliation': 'Department of Internal Medicine, Groene Hart Ziekenhuis, Gouda, the Netherlands.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Szatkowski', 'Affiliation': 'Department of Oncology, Haematology and Palliative Care, Førde Central Hospital, Førde, Norway.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Brouwer', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Ziekenhuis, Delft, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Internal Medicine, Northwest Clinics, Alkmaar, the Netherlands.'}, {'ForeName': 'Rineke', 'Initials': 'R', 'LastName': 'Leys', 'Affiliation': 'Department of Internal Medicine, Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Sinnige', 'Affiliation': 'Department of Internal Medicine, Jeroen Bosch Ziekenhuis, Den Bosch, the Netherlands.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Haukås', 'Affiliation': 'Department of Haematology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Klaas', 'Initials': 'K', 'LastName': 'van der Hem', 'Affiliation': 'Department of Internal Medicine, Zaans Medisch Centrum, Zaandam, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Durian', 'Affiliation': 'Department of Internal Medicine, Tweesteden Ziekenhuis, Tilburg, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gimsing', 'Affiliation': 'Department of Haematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van de Donk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Haematology, Erasmus Medical Center Cancer Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': 'Department of Haematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Abildgaard', 'Affiliation': 'Quality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Hematology, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}]",Haematologica,['10.3324/haematol.2019.222299'] 1696,31816249,"The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response.","OBJECTIVE To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, randomized study (NCT02066415). METHODS Patients (n = 667) received (3:2:2) placebo or erenumab 70/140 mg once-monthly. The proportion of patients achieving a given response threshold was assessed. A post-hoc analysis was conducted to contextualize the actual treatment benefit in subgroups of patients achieving (or not) specified response thresholds. Outcome measures included MMD, acute migraine-specific medication treatment days (MSMD) and disability. RESULTS The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds. At month 3, 39.9% and 41.2% of patients on erenumab 70 and 140 mg, respectively, achieved ≥50% response versus placebo (23.5%). Similarly, at month 3, 17.0% and 20.9% of patients on erenumab 70 and 140 mg, respectively, achieved ≥75% response versus placebo (7.8%). Compared with the overall erenumab-treated population (change in MMD: -6.6 [both 70 and 140 mg]), ≥50% responders showed MMD reductions of -12.2/-12.5 for 70 mg/140 mg versus -2.6/-2.2 for those not achieving ≥50% response. ≥75% responders showed MMD reductions of -13.9/-14.8 for 70 mg/140 mg versus -5.0/-4.3 for those not achieving ≥75% response. Relative improvements in MSMD and disability were observed in responders versus overall erenumab-treated population. CONCLUSION For erenumab-treated patients achieving ≥50% response, the actual reduction in MMD was almost twice that of the overall population. These findings provide context for setting realistic expectations regarding actual treatment benefit experienced by patients responding to treatment.",2020,The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds.,"['patients with chronic migraine', 'patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response', 'Patients (n\u2009=\u2009667']","['placebo or erenumab 70/140\u2009mg once-monthly', 'placebo', 'MMD']","['MMD reductions', 'MSMD and disability', 'actual reduction in MMD', 'proportion of patients responding to erenumab', 'MMD, acute migraine-specific medication treatment days (MSMD) and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0585302', 'cui_str': 'Once monthly (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",667.0,0.0842084,The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds.,"[{'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group, NUMC, Vanderbilt University, Department of Neurology, Nashville, TN, USA.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Faculty of Medicine, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dolezil', 'Affiliation': 'Prague Headache Center, DADO MEDICAL s.r.o., Prague, Czech Republic.'}, {'ForeName': 'Marshall C', 'Initials': 'MC', 'LastName': 'Freeman', 'Affiliation': 'Headache Wellness Center, Greensboro, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, CT, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Winner', 'Affiliation': 'Palm Beach Headache Center, West Palm Beach, FL, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klatt', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Ritter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lenz', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419894559'] 1697,32433165,Effect of Different 131I Dose Strategies for Treatment of Hyperthyroidism on Graves' Ophthalmopathy.,"PURPOSE The study aims to define the effect of different dose strategies on ophthalmic complications in patients with Graves' disease (GD). METHODS All the patients with GD and no or inactive ophthalmopathy (clinical activity score; CAS < 3) underwent Snellen chart examination, measurement of proptosis, thyroid volume, and radioactive iodine uptake, and randomized into 1 of 3 groups. In group 1, all the patients received fixed low dose (FLD) of 259 MBq of I, whereas in group 2, all the patients received fixed high dose (FHD) of 555 MBq, and in group 3, calculated dose (CD) was administered to deliver 5.55 MBq/g (thyroid weight) of I. All examinations were repeated 6 months after treatment. The measurement of thyroid function tests and clinical examination were repeated after 12 months. RESULTS We studied 92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years. Overall, 29, 32, and 31 patients were studied in FLD, FHD, and CD groups, respectively. The patients in CD received a mean activity of 240.5 MBq. The 3 groups were not significantly different regarding age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis. The response rate 12 months after radioactive iodine therapy was 66.7%, 94.4%, and 92.9% in FLD, FHD, and CD groups, respectively (P = 0.05). Overall, CAS was increased significantly after treatment. Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05). The highest increment in proptosis was seen in FHD group. CONCLUSIONS The administration of 5.55 MBq/g of I has fewer ophthalmic complications compared with high fixed dose model and is more effective than low fixed dose strategy.",2020,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"['92 patients (58 female and 34 male) with mean age of 38.2 ± 12.0 years', ""patients with Graves' disease (GD""]",['radioactive iodine therapy'],"['Delta proptosis and delta CAS', 'response rate', 'ophthalmic complications', 'age, sex ratio, radioactive iodine uptake, smoking, visual acuity, and proptosis', 'CAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0203610', 'cui_str': 'Teleradiotherapy with iodine-125'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0015300', 'cui_str': 'Exophthalmos'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0203778', 'cui_str': 'Radionuclide imaging of thyroid using iodine radioisotope'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",92.0,0.0359855,Delta proptosis and delta CAS were increased significantly in FHD group compared with other groups (P < 0.05).,"[{'ForeName': 'Shahrara', 'Initials': 'S', 'LastName': 'Ariamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Narjess', 'Initials': 'N', 'LastName': 'Ayati', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mazloum Khorasani', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mousavi', 'Affiliation': 'Metabolic Syndrome Research Center.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Kiavash', 'Affiliation': 'Ophthalmology Department, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiamanesh', 'Affiliation': 'From the Nuclear Medicine Research Center.'}, {'ForeName': 'Seyed Rasoul', 'Initials': 'SR', 'LastName': 'Zakavi', 'Affiliation': 'From the Nuclear Medicine Research Center.'}]",Clinical nuclear medicine,['10.1097/RLU.0000000000003086'] 1698,31393651,Clinical evaluation of chairside Computer Assisted Design/Computer Assisted Machining nano-ceramic restorations: Five-year status.,"OBJECTIVES This investigation was a longitudinal, randomized clinical trial to measure the clinical performance of a nano-ceramic material (Lava Ultimate/3M) for chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) fabricated restorations. MATERIALS AND METHODS One hundred and twenty chairside CAD/CAM onlays were restored with a CEREC system randomly assigned to 60 leucite-reinforced ceramic (IPS EmpressCAD/Ivoclar Vivadent AGBendererstrasse 2FL-9494 SchaanLiechtenstein) onlays and 60 nano-ceramic (Lava Ultimate/3M) onlays. Equal groups of onlays were cemented using a self-etch and a total etch adhesive resin cement. The onlays were recalled for a period of 5 years. RESULTS At 1 week postoperatively, 10% of the onlays cemented with both the self-etch and total etch adhesive resin cements were reported as slightly sensitive. However, all patients were asymptomatic by the 4th week without treatment. Four leucite-reinforced onlays and one nano-ceramic onlay fractured and required replacement. CONCLUSIONS Adhesive retention with a self-etch or total etch cementation technique resulted in a similar clinical outcome with no reported debonds. The nano-ceramic onlays had a lower incidence of fracture compared to the leucite-reinforced ceramic onlays with both having a very low risk of fracture. Nano-ceramic onlays performed equally as well as glass ceramic onlays over 5 years of clinical service. CLINICAL SIGNIFICANCE Ceramic materials have been a mainstay for chairside CAD/CAM restorations for the past 30 years and a new category of resilient ceramics with a resin matrix has been introduced reported to offer ceramic-like durability and esthetics with resin-like efficiency in handling. There are no long-term clinical studies on the performance of these materials. This is a 5-year randomized clinical trial on the performance of nano-ceramic onlays.",2020,The nano-ceramic onlays had a lower incidence of fracture compared to the leucite-reinforced ceramic onlays with both having a very low risk of fracture.,['One hundred and twenty chairside CAD/CAM onlays'],"['chairside Computer Assisted Design/Computer', '60 leucite-reinforced ceramic (IPS EmpressCAD/Ivoclar Vivadent AGBendererstrasse 2FL-9494 SchaanLiechtenstein) onlays and 60 nano-ceramic (Lava Ultimate/3M) onlays', 'nano-ceramic material (Lava Ultimate/3M']",[],"[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0444744', 'cui_str': 'Chairside (environment)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}]","[{'cui': 'C0444744', 'cui_str': 'Chairside (environment)'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0211161', 'cui_str': 'leucite'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],,0.0371885,The nano-ceramic onlays had a lower incidence of fracture compared to the leucite-reinforced ceramic onlays with both having a very low risk of fracture.,"[{'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Fasbinder', 'Affiliation': 'Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gisele F', 'Initials': 'GF', 'LastName': 'Neiva', 'Affiliation': 'Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Heys', 'Affiliation': 'Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, Michigan.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12516'] 1699,32493290,Pre-application of dentin bonding agent prevents discoloration caused by mineral trioxide aggregate.,"BACKGROUND To evaluate tooth discoloration by newly developed calcium silicate-based materials, and to examine the pre-application of dentin bonding agent (DBA) for preventing discoloration caused by mineral trioxide aggregate (MTA). METHODS The roots of 50 premolars were randomly divided into five groups (n = 10) and cavities were prepared from resected root surfaces. MTA was placed in the cavities of teeth belonging to the ProRoot MTA (MTA) and RetroMTA (RMTA) groups. For teeth belonging to the ProRoot + DBA (MTA-B) and RetroMTA + DBA (RMTA-B) groups, DBA was first applied to the cavities prior to the addition of MTA. Teeth in the control group were restored with composite resin only (i.e., without MTA). After 12 weeks, MTA was removed from the MTA and RMTA groups and bleaching agents were applied for 3 additional weeks. Color assessments were recorded at baseline, and 1, 4, and 12 weeks, as well as after bleaching. A one-way ANOVA was performed to assess the differences between the two types of MTAs and color changes following DBA pre-application in each MTA group. A p-value of < 0.05 was considered indicative of statistical significance. RESULTS Following 12 weeks of MTA treatment, there was a significant difference between the discoloration in the MTA and RMTA groups (p < 0.05). However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05). Following bleaching, the color changes (ΔE values) of the MTA group were not significantly different from those of the MTA-B group (p > 0.05). The difference of ΔE between the RMTA group after internal bleaching and the RMTA-B group was also not significant (p > 0.05). CONCLUSIONS RetroMTA caused significantly less discoloration than ProRoot MTA. Pre-application of DBA reduced discoloration caused by ProRoot MTA. MTA discoloration was improved equally well between DBA pre-application and post-bleaching.",2020,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).",['50 premolars'],"['MTA', 'RetroMTA']","['discoloration', 'MTA discoloration']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C4310582', 'cui_str': 'RetroMTA'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}]",50.0,0.0141938,"However, no significant difference was observed between the RMTA and RMTA-B groups (p > 0.05).","[{'ForeName': 'Yoo-Lim', 'Initials': 'YL', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.'}, {'ForeName': 'Bom Sahn', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, College of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Yemi', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, College of Medicine, Ewha Womans University, 1071, Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea. yemis@ewha.ac.kr.'}]",BMC oral health,['10.1186/s12903-020-01151-1'] 1700,30189000,Engaging hospital patients in the medication reconciliation process using tablet computers.,"Objective Unintentional medication discrepancies contribute to preventable adverse drug events in patients. Patient engagement in medication safety beyond verbal participation in medication reconciliation is limited. We conducted a pilot study to determine whether patients' use of an electronic home medication review tool could improve medication safety during hospitalization. Materials and Methods Patients were randomized to use a tool before or after hospital admission medication reconciliation to review and modify their home medication list. We assessed the quantity, potential severity, and potential harm of patients' and clinicians' medication changes. We also surveyed clinicians to assess the tool's usefulness. Results Of 76 patients approached, 65 (86%) participated. Forty-eight (74%) made changes to their home medication list [before: 29 (81%), after: 19 (66%), p = .170]. Before group participants identified 57 changes that clinicians subsequently missed on admission medication reconciliation. Thirty-nine (74%) had a significant or greater potential severity, and 19 (36%) had a greater than 50-50 chance of harm. After group patients identified 68 additional changes to their reconciled medication lists. Fifty-one (75%) had a significant or greater potential severity, and 33 (49%) had a greater than 50-50 chance of harm. Clinicians reported believing that the tool would save time, and patients would supply useful information. Discussion The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed. Conclusion Engaging patients in admission medication reconciliation using an electronic home medication review tool may improve medication safety during hospitalization.",2018,"The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed. ","['76 patients approached, 65 (86%) participated', 'patients']",[],"['admission medication reconciliation', 'medication safety', 'potential severity', ""quantity, potential severity, and potential harm of patients' and clinicians' medication changes""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",[],"[{'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}]",76.0,0.0266847,"The results demonstrate a high willingness of patients to engage in medication reconciliation, and show that patients were able to identify important medication discrepancies and often changes that clinicians missed. ","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Prey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Polubriaginof', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Grossman', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Masterson Creber', 'Affiliation': 'School of Nursing, Columbia University, New York, New York, USA.'}, {'ForeName': 'Demetra', 'Initials': 'D', 'LastName': 'Tsapepas', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Perotte', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Restaino', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bakken', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hripcsak', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Efird', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': 'Value Institute at NewYork-Presbyterian Hospital, New York, New York, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Vawdrey', 'Affiliation': 'Department of Biomedical Informatics, Columbia University, New York, New York, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy115'] 1701,30216846,Extracellular vesicle-enriched microRNAs interact in the association between long-term particulate matter and blood pressure in elderly men.,"BACKGROUND Several studies have shown that exposure to particulate matter (PM) may lead to increased systemic blood pressure, but the underlying biological mechanisms remain unknown. Emerging evidence shows that extracellular vesicle-enriched miRNAs (evmiRNAs) are associated with PM exposure and cardiovascular risk. In this study, we investigated the role of evmiRNAs in the association between PM and blood pressure, as well as their epigenetic regulation by DNA methylation. METHODS Participants (n = 22, men) were randomly selected from the Veterans Affairs Normative Aging Study (NAS). Long-term (1-year and 6-month average) PM 2.5 exposure was estimated at 1 × 1-km resolution using spatio-temporal prediction models and BC was estimated using validated time varying land use regression models. We analyzed 31 evmiRNAs detected in ≥ 90% of all individuals and for statistical analysis, we used mixed effects models with random intercept adjusted for age, body mass index, smoking, C-reactive protein, platelets, and white blood cells. RESULTS We found that per each 2-standard deviations increase in 6-month PM 2.5 ambient levels, there was an increase in 0.19 mm Hg (95% Confidence Interval [95%CI]: 0.11, 0.28 mmHg; p < 0.001) in systolic blood pressure (SBP). Per each 2-standard deviations increase in 1-year PM 2.5 levels, there was an increase in 0.11 mm Hg (95% Confidence Interval [95% CI]: 0.03, 0.19 mmHg; p = 0.012) in SBP in older male individuals. We also found that both miR-199a/b (β = 6.13 mmHg; 95% CI: 0.87, 11.39; p interaction = 0.07) and miR-223-3p (β = 30.17 mmHg; 95% CI: 11.96, 48.39 mmHg; p interaction = 0.01) modified the association between 1-year PM 2.5 and SBP. When exploring DNA methylation as a potential mechanism that could epigenetically regulate expression of evmiRNAs, we found that PM 2.5 ambient levels were negatively associated with DNA methylation levels at CpG (cg23972892) near the enhancer region of miR-199a/b (β = -13.11; 95% CI: -17.70, -8.52; p Bonferroni < 0.01), but not miR-223-3p. CONCLUSIONS Our findings suggest that expression of evmiRNAs may be regulated by DNA methylation in response to long-term PM 2.5 ambient levels and modify the magnitude of association between PM 2.5 and systolic blood pressure in older individuals.",2018,"(β = -13.11; 95% CI: -17.70, -8.52; p Bonferroni < 0.01), but not miR-223-3p. ","['Participants (n\u202f=\u202f22, men) were randomly selected from the Veterans Affairs Normative Aging Study (NAS', 'elderly men', 'older male individuals']",[],"['systolic blood pressure (SBP', 'systolic blood pressure']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.106927,"(β = -13.11; 95% CI: -17.70, -8.52; p Bonferroni < 0.01), but not miR-223-3p. ","[{'ForeName': 'Rodosthenis S', 'Initials': 'RS', 'LastName': 'Rodosthenous', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Harvard University, 665 Huntington Ave, Boston, MA 02115, United States; Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA 02114, United States. Electronic address: rrodosth@hsph.harvard.com.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Kloog', 'Affiliation': 'Department of Geography and Environmental Development, Ben-Gurion University of the Negev, 663 Beer Sheva, Israel. Electronic address: ikloog@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Colicino', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Harvard University, 665 Huntington Ave, Boston, MA 02115, United States; Icahn School of Medicine, Mount Sinai Hospital, 1 Gustave L. Levy Place, New York, NY 10029-5674, United States. Electronic address: elena.colicino@mssm.edu.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Harvard University, 665 Huntington Ave, Boston, MA 02115, United States. Electronic address: Jia.zhong@analysisgroup.com.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Herrera', 'Affiliation': 'Unidad de Investigación Biomédica en Cáncer, Instituto Nacional de Cancerología - Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City 14080, Mexico. Electronic address: herreram@biomedicas.unam.mx.'}, {'ForeName': 'Pantel', 'Initials': 'P', 'LastName': 'Vokonas', 'Affiliation': 'Veterans Affairs Boston Healthcare System, 150 South Huntington Ave, Boston, MA 02130, United States; Department of Epidemiology, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, United States; Department of Medicine, Boston University School of Medicine, 72 East Concord Street, Boston, MA 02118, United States. Electronic address: Pantel.Vokonas@va.gov.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Harvard University, 665 Huntington Ave, Boston, MA 02115, United States. Electronic address: joel@hsph.harvard.edu.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Baccarelli', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY 10032, United States. Electronic address: ab4303@cumc.columbia.edu.'}, {'ForeName': 'Diddier', 'Initials': 'D', 'LastName': 'Prada', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Harvard University, 665 Huntington Ave, Boston, MA 02115, United States; Unidad de Investigación Biomédica en Cáncer, Instituto Nacional de Cancerología - Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City 14080, Mexico. Electronic address: dpradao@incan.edu.mx.'}]",Environmental research,['10.1016/j.envres.2018.09.002'] 1702,31779672,ReferencesEfficiency and safety of renal denervation via cryoablation (Cryo-RDN) in Chinese patients with uncontrolled hypertension: study protocol for a randomized controlled trial.,"BACKGROUND Clinical data show that due to the limited effects of lifestyle regulation and unsatisfactory drug adherence, only half of the hypertensive population have their blood pressure (BP) under control. In recent years, catheter-based renal denervation (RDN) has been used as a novel approach for treating uncontrolled hypertension. The safety and efficacy of catheter-based RDN have been confirmed by a number of studies and trials in which the participants were all non-Chinese and RDN was conducted via radiofrequency or ultrasound. METHODS/DESIGN This study is a prospective multicenter randomized sham-controlled trial that aims to investigate the safety and efficacy of cryoablation RDN (cryo-RDN) using a novel dedicated cryoablation balloon catheter (Cryofocus, China). A total of 200 Chinese patients who have uncontrolled hypertension despite standard medical treatment will be enrolled. With drug standardization, eligible participants will be randomized in a 1:1 ratio to undergo cryo-RDN treatment or renal angiography alone as a sham treatment. The primary endpoint is defined as the change in 24-h ambulatory systolic blood pressure from baseline to 6 months. Office BP and other 24-h ambulatory BP are included as secondary endpoints. Safety endpoints primarily include any adverse effects. DISCUSSION This study was designed to verify the safety and efficacy of cryo-RDN with Cryofocus balloon catheters in uncontrolled hypertensive patients on polypharmacy. The aim is to provide a new way to improve the control of hypertension in China as a complement to drug therapy. TRIAL REGISTRATION ChiCTR, ChiCTR1800017707. Registered on 10 August 2018.",2019,"This study is a prospective multicenter randomized sham-controlled trial that aims to investigate the safety and efficacy of cryoablation RDN (cryo-RDN) using a novel dedicated cryoablation balloon catheter (Cryofocus, China).","['uncontrolled hypertensive patients on polypharmacy', '200 Chinese patients who have uncontrolled hypertension despite standard medical treatment will be enrolled', 'Chinese patients with uncontrolled hypertension']","['catheter-based renal denervation (RDN', 'renal denervation via cryoablation (Cryo-RDN', 'cryo-RDN treatment or renal angiography alone', 'cryoablation RDN (cryo-RDN', 'cryo-RDN with Cryofocus balloon catheters', 'catheter-based RDN']","['change in 24-h ambulatory systolic blood pressure', 'adverse effects', 'blood pressure (BP', 'safety and efficacy', 'Office BP and other 24-h ambulatory BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202930', 'cui_str': 'Renal angiogram'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]",,0.193157,"This study is a prospective multicenter randomized sham-controlled trial that aims to investigate the safety and efficacy of cryoablation RDN (cryo-RDN) using a novel dedicated cryoablation balloon catheter (Cryofocus, China).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Lingjuan', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'CryoFocus MedTech (Shanghai) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China. shen.li1@zs-hospital.sh.cn.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China. ge.junbo2@zs-hospital.sh.cn.'}]",Trials,['10.1186/s13063-019-3693-9'] 1703,15449353,Functional neuroanatomy of perceiving surprised faces.,"Surprise is one of six emotions having a specific and universally recognized facial expression. Functional imaging and neuropsychologic studies have uncovered partly separable neural substrates for perceiving different facial expressions; however, the functional neuroanatomy of perceiving surprised faces has not yet been investigated. Using functional magnetic resonance imaging (fMRI), we aimed to identify the neural substrate of surprise perception from facial expressions. Based on the assumption of unexpectedness and novelty as elicitors of facial surprise reactions, we hypothesized recruitment of medial temporal lobe structures implicated in novelty detection during the perception of surprise in others. Healthy subjects were scanned while they were presented with surprised faces. As a control, they viewed faces depicting neutral or disgust expressions. Activations during the emotional conditions were contrasted with each other and with the neutral face condition. Compared to both control conditions, perception of surprised facial expressions yielded consistently increased signals in the parahippocampal region, an area associated previously with novelty detection. Our findings therefore suggest a close relation between perceiving surprise in others and the response to novel events. Additionally, we confirmed activation of the insula during perception of disgust expressions.",2004,"Compared to both control conditions, perception of surprised facial expressions yielded consistently increased signals in the parahippocampal region, an area associated previously with novelty detection.",['Healthy subjects'],['functional magnetic resonance imaging (fMRI'],['Functional neuroanatomy of perceiving surprised faces'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0027816', 'cui_str': 'Neuranatomy'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.0451753,"Compared to both control conditions, perception of surprised facial expressions yielded consistently increased signals in the parahippocampal region, an area associated previously with novelty detection.","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schroeder', 'Affiliation': 'Department of Neurology, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hennenlotter', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Erhard', 'Affiliation': ''}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haslinger', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stahl', 'Affiliation': ''}, {'ForeName': 'Klaus W', 'Initials': 'KW', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Andrés O', 'Initials': 'AO', 'LastName': 'Ceballos-Baumann', 'Affiliation': ''}]",Human brain mapping,[] 1704,31515716,Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures.,"Reductions in positive affect are a salient feature of preschool-onset major depressive disorder. Yet, little is known about the psychophysiological correlates of this blunted positive affect and whether reduced physiological responding to pleasant stimuli may differentiate depressed and healthy young children. 120 four-to-seven year old children with current depression and 63 psychiatrically healthy 4-to-7 year old children completed a simple picture-viewing task of pleasant and neutral pictures while event-related potentials (ERPs) were recorded. The early-childhood version of the Kiddie Schedule for Affective Disorders and Depression was used to establish psychiatric diagnoses. A one-way ANCOVA was used to test for group differences in response to pleasant and neutral pictures. Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02). The LPP for the children with preschool-onset depression (M = 0.99, SE = 0.65) was significantly smaller than the LPP in the healthy group of young children (M = 3.27, SE = 0.90). This difference did not vary as a function of depression or anhedonia severity within the group with depression or the healthy children. Similar to older children and adolescents with depression, young children with depression display reductions in responsivity to pleasant stimuli as indexed by the LPP. These findings extend prior findings indicating a blunted response to pleasant stimuli in preschool- onset depression. Given the greater neuroplasticity of emotional response and regulation, these findings suggest clinical attention to emotional response to pleasure is an important target in preschool-onset depression. Clinical trial registration information: A Randomized Control Trial of PCIT-ED for Preschool Depression; http://clinicaltrials.gov/;NCT02076425.",2020,"Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02).","['120 four-to-seven year old children with current depression and 63 psychiatrically healthy 4-to-7\xa0year old children completed a', 'Young children with depression', 'healthy young children', 'Preschool-Onset Major Depressive Disorder']","['PCIT-ED', 'simple picture-viewing task of pleasant and neutral pictures while event-related potentials (ERPs']","['reduced response to pleasant vs. neutral pictures (LPP', 'function of depression or anhedonia severity']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.104051,"Young children with depression showed a reduced response to pleasant vs. neutral pictures (LPP), after controlling for children's age (F(1,180) = 4.15, p = 0.04, η2 = 0.02).","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA. diana.whalen@wustl.edu.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Hajcak', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Kappenman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine in St. Louis, 4444 Forest Park, Suite 2100, St. Louis, MO, 63108, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00585-8'] 1705,32493276,The effect of intraoperative lidocaine infusion on opioid consumption and pain after totally extraperitoneal laparoscopic inguinal hernioplasty: a randomized controlled trial.,"BACKGROUND As a component of multimodal analgesia, the administration of systemic lidocaine is a well-known technique. We aimed to evaluate the efficacy of lidocaine infusion on postoperative pain-related outcomes in patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty. METHODS In this randomized controlled double-blind study, we recruited 64 patients to receive either lidocaine 2% (intravenous bolus 1.5 mg. kg - 1 followed by an infusion of 2 mg. kg - 1 . h - 1 ), or an equal volume of normal saline. The infusion was initiated just before the induction of anesthesia and discontinued after tracheal extubation. The primary outcome of the study was postoperative morphine equivalent consumption up to 24 h after surgery. Secondary outcomes included postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain. RESULTS The median (IQR) cumulative postoperative morphine equivalent consumption in the first 24 h was 0 (0-1) mg in the lidocaine group and 4 [1-8] mg in the saline group (p < 0.001). Postoperative pain intensity at rest and during movement at various time points in the first 24 h were significantly lower in the lidocaine group compared with the saline group (p < 0.05). Fewer patients reported PONV in the lidocaine group than in the saline group (p < 0.05). Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001). Patients receiving lidocaine were more satisfied with postoperative analgesia than those receiving saline (p = 0.02). No difference was detected in terms of postoperative sedation and chronic pain after surgery. CONCLUSIONS Intraoperative lidocaine infusion for laparoscopic TEP inguinal hernioplasty reduces opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction. TRIAL REGISTRATION ClinicalTrials.gov- NCT02601651. Date of registration: November 10, 2015.",2020,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"['patients undergoing totally extraperitoneal (TEP) laparoscopies inguinal hernioplasty', '64 patients to receive either', 'after totally extraperitoneal laparoscopic inguinal hernioplasty']","['lidocaine infusion', 'lidocaine', 'intraoperative lidocaine infusion', 'lidocaine 2% (intravenous bolus 1.5\u2009mg']","['postoperative morphine equivalent consumption', 'satisfied with postoperative analgesia', 'postoperative pain scores, nausea/vomiting (PONV), sedation, quality of recovery (scores based on QoR-40 questionnaire), patient satisfaction, and the incidence of chronic pain', 'median (IQR) cumulative postoperative morphine', 'postoperative pain-related outcomes', 'PONV', 'opioid consumption, pain intensity, PONV and improves the quality of recovery and patient satisfaction', 'Median QoR scores', 'opioid consumption and pain', 'Postoperative pain intensity', 'equivalent consumption', 'postoperative sedation and chronic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.699271,Median QoR scores at 24 h after surgery were significantly better in the lidocaine group (194 (194-196) than saline group 184 (183-186) (p < 0.001).,"[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Ghimire', 'Affiliation': 'Department of Anesthesiology, Nepal Mediciti Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Subedi', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal. asishsubedi19@gmail.com.'}, {'ForeName': 'Balkrishna', 'Initials': 'B', 'LastName': 'Bhattarai', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Birendra Prasad', 'Initials': 'BP', 'LastName': 'Sah', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, Dharan, Nepal.'}]",BMC anesthesiology,['10.1186/s12871-020-01054-2'] 1706,31500139,Systematic Assessment of Blood-Borne MicroRNAs Highlights Molecular Profiles of Endurance Sport and Carbohydrate Uptake.,"Multiple studies endorsed the positive effect of regular exercise on mental and physical health. However, the molecular mechanisms underlying training-induced fitness in combination with personal life-style remain largely unexplored. Circulating biomarkers such as microRNAs (miRNAs) offer themselves for studying systemic and cellular changes since they can be collected from the bloodstream in a low-invasive manner. In Homo sapiens miRNAs are known to regulate a substantial number of protein-coding genes in a post-transcriptional manner and hence are of great interest to understand differential gene expression profiles, offering a cost-effective mechanism to study molecular training adaption, and connecting the dots from genomics to observed phenotypes. Here, we investigated molecular expression patterns of 2549 miRNAs in whole-blood samples from 23 healthy and untrained adult participants of a cross-over study, consisting of eight weeks of endurance training, with several sessions per week, followed by 8 weeks of washout and another 8 weeks of running, using microarrays. Participants were randomly assigned to one of the two study groups, one of which administered carbohydrates before each session in the first training period, and switching the treatment group for the second training period. During running sessions clinical parameters as heartbeat frequency were recorded. This information was extended with four measurements of maximum oxygen uptake (VO 2 max) for each participant. We observed that multiple circulating miRNAs show expression changes after endurance training, leveraging the capability to separate the blood samples by training status. To this end, we demonstrate that most of the variance in miRNA expression can be explained by both common and known biological and technical factors. Our findings highlight six distinct clusters of miRNAs, each exhibiting an oscillating expression profile across the four study timepoints, that can effectively be utilized to predict phenotypic VO 2 max levels. In addition, we identified miR-532-5p as a candidate marker to determine personal alterations in physical training performance on a case-by-case analysis taking the influence of a carbohydrate-rich nutrition into account. In literature, miR-532-5p is known as a common down-regulated miRNA in diabetes and obesity, possibly providing a molecular link between cellular homeostasis, personal fitness levels, and health in aging. We conclude that circulating miRNA expression can be altered due to regular endurance training, independent of the carbohydrate (CHO) availability in the training timeframe. Further validation studies are required to confirm the role of exercise-affected miRNAs and the extraordinary function of miR-532-5p in modulating the metabolic response to a high availability of glucose.",2019,"In Homo sapiens miRNAs are known to regulate a substantial number of protein-coding genes in a post-transcriptional manner and hence are of great interest to understand differential gene expression profiles, offering a cost-effective mechanism to study molecular training adaption, and connecting the dots from genomics to observed phenotypes.","['23 healthy and untrained adult participants of a cross-over study, consisting of eight weeks of']","['endurance training', 'regular exercise']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]",[],6.0,0.0196868,"In Homo sapiens miRNAs are known to regulate a substantial number of protein-coding genes in a post-transcriptional manner and hence are of great interest to understand differential gene expression profiles, offering a cost-effective mechanism to study molecular training adaption, and connecting the dots from genomics to observed phenotypes.","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Kern', 'Affiliation': 'Chair for Clinical Bioinformatics, Saarland University, 66123 Saarbrücken, Germany. fabian.kern@ccb.uni-saarland.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ludwig', 'Affiliation': 'Department of Human Genetics, Saarland University Hospital, 66421 Homburg, Germany. n.ludwig@mx.uni-saarland.de.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Backes', 'Affiliation': 'Chair for Clinical Bioinformatics, Saarland University, 66123 Saarbrücken, Germany. c.backes@mx.uni-saarland.de.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Maldener', 'Affiliation': 'Department of Human Genetics, Saarland University Hospital, 66421 Homburg, Germany. Esther.Maldener@uks.eu.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Fehlmann', 'Affiliation': 'Chair for Clinical Bioinformatics, Saarland University, 66123 Saarbrücken, Germany. tobias.fehlmann@ccb.uni-saarland.de.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Suleymanov', 'Affiliation': 'Chair for Clinical Bioinformatics, Saarland University, 66123 Saarbrücken, Germany. artur.suleymanov@uni-saarland.de.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Meese', 'Affiliation': 'Department of Human Genetics, Saarland University Hospital, 66421 Homburg, Germany. Eckart.Meese@uks.eu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hecksteden', 'Affiliation': 'Department of Sports Medicine, Saarland University, 66123 Saarbrücken, Germany. a.hecksteden@mx.uni-saarland.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Keller', 'Affiliation': 'Chair for Clinical Bioinformatics, Saarland University, 66123 Saarbrücken, Germany. andreas.keller@ccb.uni-saarland.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Department of Sports Medicine, Saarland University, 66123 Saarbrücken, Germany. tim.meyer@mx.uni-saarland.de.'}]",Cells,['10.3390/cells8091045'] 1707,31498699,"Response by Schrage et al to Letter Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0575052,,"[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schrage', 'Affiliation': 'University Heart Centre Hamburg, Department of General and Interventional Cardiology, Germany (B.S., D.W.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen am Rhein, Germany (S.S., U.Z.).'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen am Rhein, Germany (S.S., U.Z.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Germany (H.T.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Westermann', 'Affiliation': 'University Heart Centre Hamburg, Department of General and Interventional Cardiology, Germany (B.S., D.W.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041637'] 1708,31502662,Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device for Acne Patients: A Prospective Randomized Controlled Study.,"BACKGROUND AND OBJECTIVES The selective electrothermolysis of the sebaceous glands was suggested as a novel therapeutic option for facial acne. However, there has been no randomized controlled trial to evaluate the effectiveness and safety of the monopolar radiofrequency (RF) device using single microneedle with proximal insulation. The objective of the study was to evaluate the efficacy and tolerability of intralesional electrothermolysis using monopolar RF device and proximally-insulated single microneedle in acne patients. STUDY DESIGN/MATERIALS AND METHODS The prospective randomized controlled clinical trial was performed to treat moderate-to-severe facial acne. Subjects randomized to the treatment group received three treatments at 4-week intervals with an RF device, whereas the control group received micro-needling and extraction. For efficacy evaluation, reduction rate of acne lesions were evaluated by two independent physicians. RESULTS Sixty-three patients completed the study and the results showed statistically significant improvement of inflammatory acne at 12 weeks. The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls. CONCLUSIONS Selective sebaceous gland electrothermolysis can be a safe and effective method of achieving consistent improvement in acne. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls. ","['Acne Patients', '2019', 'acne patients', 'moderate-to-severe facial acne']","['Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device', 'intralesional electrothermolysis', 'control group received micro-needling and extraction', 'monopolar RF device and proximally-insulated single microneedle', 'monopolar radiofrequency (RF) device']","['number of inflammatory lesions', 'inflammatory acne', 'efficacy and tolerability', 'reduction rate of acne lesions']","[{'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0036505', 'cui_str': 'Sebaceous Glands'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",63.0,0.0501248,"The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls. ","[{'ForeName': 'Ga Ram', 'Initials': 'GR', 'LastName': 'Ahn', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kapsok', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Lasers in surgery and medicine,['10.1002/lsm.23152'] 1709,31492095,Effect of pre-discharge cardiopulmonary fitness on outcomes in patients with ST-elevation myocardial infarction after percutaneous coronary intervention.,"BACKGROUND The purpose of this study was to analyze cardiopulmonary fitness in Phase I cardiac rehabilitation on the prognosis of patients with ST-Elevation Myocardial Infarction (STEMI) after percutaneous coronary intervention (PCI). METHODS The study enrolled a total of 499 STEMI patients treated with PCI between January 2015 and December 2015. Patients were assigned to individualized exercise prescriptions (IEP) group and non-individualized exercise prescriptions (NIEP) group according to whether they accept or refuse individualized exercise prescriptions. We compared the incidence of major cardiovascular events between the two groups. IEP group were further divided into two subgroups based on prognosis status, namely good prognosis (GP) group and poor prognosis (PP) group. Key cardio-pulmonary exercise testing (CPX) variables that may affect the prognosis of patients were identified through comparison of the cardio-respiratory fitness (CRF). RESULTS There is no significant difference in the incidence of cardio-genetic death, re-hospitalization, heart failure, stroke, or atrial fibrillation between the IEP and the NIEP group. But the incidence of total major adverse cardiac events (MACE) was significantly lower in the IEP group than in the NIEP group (P = 0.039). The oxygen consumption (VO 2 ) at ventilation threshold (VT), minute CO 2 ventilation (E-VCO 2 ), margin of minute ventilation carbon dioxide production (△CO 2 ) , rest partial pressure of end-tidal carbon dioxide(R-P ET CO 2 ), exercise partial pressure of end-tidal carbon dioxide(E-P ET CO 2 ) and margin of partial pressure of end-tidal carbon dioxide(△P ET CO 2 ) were significantly higher in the GP subgroup than in the PP subgroup; and the slope for minute ventilation/carbon dioxide production (V E /VCO 2 ) was significantly lower in GP subgroup than in PP subgroup (P = 0.010). The VO 2 at VT, V E /VCO 2 slope, E-VCO 2 , △CO 2 , R-P ET CO 2 , E-P ET CO 2 and margin of partial pressure of end-tidal carbon dioxide CO 2 (△P ET CO 2 ) were predictive of adverse events. The VO 2 at VT was an independent risk factor for cardiovascular disease prognosis. CONCLUSIONS Individualized exercise prescription of Phase I cardiac rehabilitation reduced the incidence of cardiovascular events in patients with STEMI after PCI. VO 2 at VT is an independent risk factor for cardiovascular disease prognosis, and could be used as an important evaluating indicator for Phase I cardiac rehabilitation.",2019,"There is no significant difference in the incidence of cardio-genetic death, re-hospitalization, heart failure, stroke, or atrial fibrillation between the IEP and the NIEP group.","['patients with ST-Elevation Myocardial Infarction (STEMI) after percutaneous coronary intervention (PCI', 'patients with ST-elevation myocardial infarction after percutaneous coronary intervention', '499 STEMI patients treated with PCI between January 2015 and December 2015', 'patients with STEMI after PCI']","['individualized exercise prescriptions (IEP) group and non-individualized exercise prescriptions (NIEP) group according to whether they accept or refuse individualized exercise prescriptions', 'NIEP', 'IEP', 'Key cardio-pulmonary exercise testing (CPX', 'I cardiac rehabilitation', 'pre-discharge cardiopulmonary fitness']","['oxygen consumption (VO 2 ) at ventilation threshold (VT), minute CO 2 ventilation (E-VCO 2 ), margin of minute ventilation carbon dioxide production (△CO 2 ) , rest partial pressure of end-tidal carbon dioxide(R-P ET CO 2 ), exercise partial pressure of end-tidal carbon dioxide(E-P ET CO 2 ) and margin of partial pressure of end-tidal carbon dioxide(△P ET CO 2 ', 'incidence of major cardiovascular events', 'incidence of cardiovascular events', 'slope for minute ventilation/carbon dioxide production', 'incidence of cardio-genetic death, re-hospitalization, heart failure, stroke, or atrial fibrillation', 'total major adverse cardiac events (MACE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020997', 'cui_str': 'Immunoelectrophoresis (procedure)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0033268'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",499.0,0.0235939,"There is no significant difference in the incidence of cardio-genetic death, re-hospitalization, heart failure, stroke, or atrial fibrillation between the IEP and the NIEP group.","[{'ForeName': 'He', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Zhaoxi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Wangshu', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Pengyu', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'The Cardiovascular Center, First Hospital of Jilin University, 71 Xinmin Road, Changchun, 130021, Jilin, China. caopy1979@outlook.com.'}]",BMC cardiovascular disorders,['10.1186/s12872-019-1189-x'] 1710,31493013,"The effect of balneotherapy and peloid therapy on changes in the functional state of patients with knee joint osteoarthritis: a randomized, controlled, single-blind pilot study.","The treatment of OA using pharmaceutical and non-pharmaceutical measures remains a topical subject. The purpose of this study is to assess the effect of natural factors (mineral water and mud) on changes in the functional state of patients with knee joint OA. Ninety-two adult people with grade I-III knee joint OA according to the Kellgren and Lawrence scoring system participated in the study. The subjects received 10 mineral water bath plus physical therapy or mud application procedures plus physical therapy or physical therapy alone every other day. The effectiveness of the treatment was assessed on the basis of anthropometric changes of data, VAS, SF-36, KOOS questionnaire indicators. Significantly greater walking speed, test of 5 sit downs/stand ups, circumference of a knee joint, flexion and extension range, flexor and extensor strength after treatment lasting 1 month were obtained in the intervention group. After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group. The positive changes in SF-36 were identified after 1 month after treatment: physical activity increased and pain decreased in the intervention groups. There was no significant difference between the averages of any KOOS subscale in groups. However, average percentages of symptoms, stiffness, and pain in the intervention groups were significantly better after treatment and lasting 1 month after treatment. Balneotherapy and peloid therapy effectively reduce pain and improve the functional state of patients with OA of a knee joint.",2020,After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group.,"['patients with knee joint OA', 'patients with OA of a knee joint', 'Ninety-two adult people with grade I-III knee joint OA according to the Kellgren and Lawrence scoring system participated in the study', 'patients with knee joint osteoarthritis']","['natural factors (mineral water and mud', 'balneotherapy and peloid therapy', '10 mineral water bath plus physical therapy or mud application procedures plus physical therapy or physical therapy alone every other day', 'Balneotherapy and peloid therapy']","['KOOS subscale', 'anthropometric changes of data, VAS, SF-36, KOOS questionnaire indicators', 'average percentages of symptoms, stiffness, and pain', 'functional state', 'pain intensity scores', 'pain', 'walking speed, test of 5 sit downs/stand ups, circumference of a knee joint, flexion and extension range, flexor and extensor strength', 'physical activity increased and pain', 'positive changes in SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0085867', 'cui_str': 'Balneotherapy'}, {'cui': 'C0026729', 'cui_str': 'Peloid Therapy'}, {'cui': 'C0150141'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0585841', 'cui_str': 'Application procedure (administrative) (procedure)'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560831', 'cui_str': 'Does sit down (finding)'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",92.0,0.0179924,After 1 month after treatment pain intensity scores over the past month and when changing position were significantly higher in the control group.,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Varzaityte', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, A. Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania. lina.varzaityte@gmail.com.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Lithuanian University of Health Sciences, A. Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania.'}, {'ForeName': 'Lolita', 'Initials': 'L', 'LastName': 'Rapoliene', 'Affiliation': 'Department of Nursing, Klaipeda University, H. Mantas str. 84, LT-92294, Klaipėda, Lithuania.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Bartuseviciute', 'Affiliation': 'Limited company Medical SPA Eglės Sanatorija, Eglės str. 1, LT-66251, Druskininkai, Lithuania.'}, {'ForeName': 'Arvydas', 'Initials': 'A', 'LastName': 'Balcius', 'Affiliation': 'Limited company Medical SPA Eglės Sanatorija, Eglės str. 1, LT-66251, Druskininkai, Lithuania.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Ramanauskas', 'Affiliation': 'Druskininkai Recreation and Health Centre, Vilniaus av. 11, LT-66119, Druskininkai, Lithuania.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Nedzelskiene', 'Affiliation': 'Department of Dental and Oral Pathology, Lithuanian University of Health Sciences, Mickevičiaus str. 9, LT-44307, Kaunas, Lithuania.'}]",International journal of biometeorology,['10.1007/s00484-019-01785-z'] 1711,31305927,Appetite Control Is Improved by Acute Increases in Energy Turnover at Different Levels of Energy Balance.,"BACKGROUND Weight control is hypothesized to be improved when physical activity and energy intake are both high [high energy turnover (ET)]. OBJECTIVE The impact of three levels of ET on short-term appetite control is therefore investigated at fixed levels of energy balance. DESIGN In a randomized crossover trial, 16 healthy adults (25.1 ± 3.9 y of age; body mass index, 24.0 ± 3.2 kg/m2) spent three daylong protocols for four times in a metabolic chamber. Four conditions of energy balance (ad libitum energy intake, zero energy balance, -25% caloric restriction, and +25% overfeeding) were each performed at three levels of ET (PAL 1.3 low, 1.6 medium, and 1.8 high ET; by walking on a treadmill). Levels of appetite hormones ghrelin, GLP-1, and insulin (total area under the curve) were measured during 14 hours. Subjective appetite ratings were assessed by visual analog scales. RESULTS Compared with high ET, low ET led to decreased GLP-1 (at all energy balance conditions: P < 0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: P < 0.001), which was consistent with higher feelings of hunger (zero energy balance: P < 0.001) and desire to eat (all energy balance conditions: P < 0.05) and a positive energy balance during ad libitum intake (+17.5%; P < 0.001). CONCLUSION Appetite is regulated more effectively at a high level of ET, whereas overeating and consequently weight gain are likely to occur at low levels of ET. In contrast to the prevailing concept of body weight control, the positive impact of physical activity is independent from burning up more calories and is explained by improved appetite sensations.",2019,"Compared to high ET, low ET led to decreased GLP-1 (at all energy balance conditions: p<0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: p<0.001) which was consistent with higher feelings of hunger (zero energy balance: p<0.001) and desire to eat (all energy balance conditions: p<0.05) and a positive energy balance during ad libitum intake (+17.5%; p<0.001). ",['16 healthy adults (25.1 ±3.9 y; BMI 24.0 ±3.2 kg/m2) spent 4 x 3 daylong protocols in a metabolic chamber'],"['energy balance (ad libitum energy intake, zero energy balance, -25% caloric restriction and +25% overfeeding']","['GLP-1', 'Visual Analogue Scales', 'Subjective appetite ratings', 'Levels of appetite hormones ghrelin, GLP-1 and insulin (tAUC', 'appetite sensations', 'ghrelin concentrations (caloric restriction and overfeeding']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}]",16.0,0.0554693,"Compared to high ET, low ET led to decreased GLP-1 (at all energy balance conditions: p<0.001) and increased ghrelin concentrations (caloric restriction and overfeeding: p<0.001) which was consistent with higher feelings of hunger (zero energy balance: p<0.001) and desire to eat (all energy balance conditions: p<0.05) and a positive energy balance during ad libitum intake (+17.5%; p<0.001). ","[{'ForeName': 'Franziska A', 'Initials': 'FA', 'LastName': 'Hägele', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Büsing', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Alessa', 'Initials': 'A', 'LastName': 'Nas', 'Affiliation': 'Department of Applied Nutritional Science and Dietetics, Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Hasler', 'Affiliation': 'Applied Statistics, Faculty of Agricultural and Nutritional Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'Manfred J', 'Initials': 'MJ', 'LastName': 'Müller', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': 'Institute of Psychological Sciences, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Bosy-Westphal', 'Affiliation': 'Department of Human Nutrition, Institute of Human Nutrition and Food Sciences, Christian-Albrechts University, Kiel, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-01164'] 1712,31549959,Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT.,"BACKGROUND Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. OBJECTIVES This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. DESIGN A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. SETTING Seven NHS hospitals. PARTICIPANTS Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. INTERVENTIONS Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. OUTCOMES The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. RESULTS The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n  = 11; plate, n  = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). CONCLUSIONS This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018; 22 (25)], which delivered to target and budget. FUTURE WORK A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. REGISTRATION Current Controlled Trials ISRCTN92089567. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.",2019,"The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month.","['Patients aged ≥\u200918 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible', 'Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation', 'Seven NHS hospitals', 'fracture of the distal femur', '23 participants', 'The sample was recruited between 29 September 2016 and 31 August 2017', 'adults with a fracture of the distal tibia']","['Intramedullary nail fixation versus locking plate fixation', 'fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture', 'Retrograde intramedullary nail fixation compared with fixed-angle plate fixation', 'plate or nail', 'UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate']","['Reduction and supplemental fixation', 'recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L', 'EQ-5D-5L', 'baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion', 'recruitment rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia (body structure)'}]","[{'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",23.0,0.204835,"The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month.","[{'ForeName': 'Xavier L', 'Initials': 'XL', 'LastName': 'Griffin', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Phelps', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tutton', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lerner', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'McGibbon', 'Affiliation': 'Patient and public representative, Coventry, UK.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23510'] 1713,32433138,Modeling Medical Education: The Impact of Three-Dimensional Printed Models on Medical Student Education in Plastic Surgery.,"PURPOSE Trainee exposure to craniofacial pathology can be limited due to rare disease presentation, revealing a need for tools that assist in visualizing complex 3D pathologic anatomy. 3D-printed models show potential as a useful aid, allowing for physical manipulation and hands-on experience. This study investigates their educational value in teaching craniofacial pathology and surgical repair. METHODS Forty-four medical students randomly assigned to a control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair. The model group was also provided with 3D-printed models of sagittal, metopic, and bicoronal synostosis, created using patient-specific preoperative computed tomography data. A survey using the Likert scale evaluated participants' learning experience. Pre- and postmodule scores on a 10-question multiple choice quiz were recorded. RESULTS The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = 0.0064), gaining an improved understanding of surgical approach (4.38 ± 0.37 versus 3.83 ± 0.29; P = 0.0266), which was more effectively taught (4.24 ± 0.33 versus 3.30 ± 0.38; P = 0.0007) with the 3D-printed models. The mean pre- and post-module quiz scores between groups were similar. CONCLUSION 3D-printed models demonstrated an improved learning experience for medical students as shown by survey. These findings suggest a potential use for 3D-printed models in medical education of craniofacial pathology and surgery.",2020,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"['Medical Student Education in Plastic Surgery', 'Modeling Medical Education', 'Forty-four medical students']",['control group or model group were given a PowerPoint presentation-based module on craniosynostosis and surgical repair'],"['learning experience', 'mean pre- and post-module quiz scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",44.0,0.0201991,The survey showed that students in the model group reported better understanding of the anatomy (4.86 ± 0.15 versus 4.26 ± 0.22; P = 0.0001) and visualization of the pathology (4.76 ± 0.23 versus 4.26 ± 0.25; P = ,"[{'ForeName': 'Jaina C', 'Initials': 'JC', 'LastName': 'Lane', 'Affiliation': 'Department of Plastic Surgery, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Black', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006567'] 1714,31846094,"Health utility of rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation.","OBJECTIVES Advanced nasal malignancies may require rhinectomy, which can have profound psychosocial impacts. Rhinectomy defects can be rehabilitated through surgery or prosthetics. We seek to understand the health utility of the rhinectomy defect, surgical, and prosthetic reconstruction, which have not been previously studied. STUDY DESIGN Prospective clinical study METHODS: Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation). Health utilities were measured using visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO). One-way analysis of variance (ANOVA) with post hoc Scheffe's test and the independent samples T-test for a priori comparisons were performed. Multiple linear regression was performed using participant demographics as independent predictors of utility scores. RESULTS Health utilities (VAS, SG, TTO) were reported as follows (mean ± SD): monocular blindness (0.71 ± 0.21, 0.84 ± 0.20, 0.85 ± 0.19), binocular blindness (0.48 ± 0.25, 0.68 ± 0.28, 0.63 ± 0.28), post-rhinectomy nasal defect (0.59 ± 0.24, 0.74 ± 0.24, 0.74 ± 0.24), postsurgical reconstruction (0.88 ± 0.16, 0.90 ± 0.18, 0.89 ± 0.13), and post-prosthetic rehabilitation (0.67 ± 0.22, 0.80 ± 0.23, 0.82 ± 0.20). Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility. SG and TTO utility scores were inversely associated with observer age (P < .001) and participants who identified themselves as non-Caucasians (P < .05) in post-rhinectomy nasal defect, post-nasal surgical reconstruction, and post-nasal prosthetic rehabilitation health states, while higher levels of education were directly associated with SG scores (P < .05), respectively. CONCLUSION This is the first study to demonstrate the significant negative impact of the rhinectomy nasal defect on health utility. Rehabilitation by surgical or prosthetic techniques significantly increases health utility as rated by naïve observers. Laryngoscope, 130:1674-1679, 2020.",2020,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"['Adult naïve observers (n = 273) ranked the utility of five randomized health states (monocular blindness, binocular blindness, post-rhinectomy nasal defect, postsurgical reconstruction, and post-prosthetic rehabilitation']","['rhinectomy, surgical nasal reconstruction, and prosthetic rehabilitation']","['prosthetic rehabilitation', 'SG scores', 'visual analogue scale (VAS), standard gamble (SG), and time trade-off (TTO', 'Health utilities (VAS, SG, TTO', 'postsurgical reconstruction', 'SG and TTO utility scores', 'Health utilities', 'health utility', 'binocular blindness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0750958', 'cui_str': 'Blindness, Monocular'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0176364', 'cui_str': 'Total rhinectomy (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}]","[{'cui': 'C0556028', 'cui_str': 'Prosthetic rehabilitation (regime/therapy)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",,0.0331634,Both surgical reconstruction (P < .001) and prosthetic rehabilitation (P < .001) significantly improved health utility.,"[{'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Faris', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Heiser', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Quatela', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Department of Otolaryngology Head & Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tessler', 'Affiliation': 'Elite Plastic Surgery, Phoenix, Arizona, U.S.A.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Jowett', 'Affiliation': 'Department of Otolaryngology, University of Antwerp Medical Center, Antwerp, Belgium, U.S.A.'}, {'ForeName': 'Linda N', 'Initials': 'LN', 'LastName': 'Lee', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28480'] 1715,31322672,Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial.,"CONTEXT Bone loss after bariatric surgery potentially could be mitigated by exercise. OBJECTIVE To investigate the role of exercise training (ET) in attenuating bariatric surgery-induced bone loss. DESIGN Randomized, controlled trial. SETTING Referral center for bariatric surgery. PATIENTS Seventy women with severe obesity, aged 25 to 55 years, who underwent Roux-en-Y gastric bypass (RYGB). INTERVENTION Supervised, 6-month, ET program after RYGB vs. standard of care (RYGB only). OUTCOMES Areal bone mineral density (aBMD) was the primary outcome. Bone microarchitecture, bone turnover, and biochemical markers were secondary outcomes. RESULTS Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P < 0.001); and increased bone turnover markers, including collagen type I C-telopeptide (CTX), procollagen type I N-propeptide (P1NP), sclerostin, and osteopontin (P < 0.05). Compared with RYGB only, exercise mitigated the percent loss of aBMD at femoral neck [estimated mean difference (EMD), -2.91%; P = 0.007;], total hip (EMD, -2.26%; P = 0.009), distal radius (EMD, -1.87%; P = 0.038), and cortical volumetric bone mineral density at distal radius (EMD, -2.09%; P = 0.024). Exercise also attenuated CTX (EMD, -0.20 ng/mL; P = 0.002), P1NP (EMD, -17.59 ng/mL; P = 0.024), and sclerostin levels (EMD, -610 pg/mL; P = 0.046) in comparison with RYGB. Exercise did not affect biochemical markers (e.g., 25(OH)D, calcium, intact PTH, phosphorus, and magnesium). CONCLUSION Exercise mitigated bariatric surgery-induced bone loss, possibly through mechanisms involving suppression in bone turnover and sclerostin. Exercise should be incorporated in postsurgery care to preserve bone mass.",2019,"RESULTS Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P<.001).","['Seventy women with severe obesity aged 25-55 years', 'women with severe obesity after Roux-en-Y gastric bypass', 'Referral center for bariatric surgery (Clinical Hospital, Sao Paulo, Brazil']","['exercise training', 'exercise training program (RYGB+ET) vs. standard of care (RYGB']","['Exercise mitigates bone loss', 'Bone microarchitecture, bone turnover and biochemical markers', 'femoral neck, total hip, distal radius, and whole body aBMD', 'total hip', 'sclerostin levels', 'cortical volumetric bone mineral density', 'biochemical markers (e.g., 25(OH)D, calcium, iPTH, phosphorus, and magnesium', 'distal radius', 'percent loss of aBMD at femoral neck', 'Areal bone mineral density (aBMD', 'bone turnover markers, including CTX, P1NP, sclerostin, and osteopontin (P<.05']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}]",70.0,0.0887808,"RESULTS Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P<.001).","[{'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Gastroenterology Department, Digestive Surgery Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Lima', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Gastroenterology Department, Digestive Surgery Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Metabolism Group, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology & Nutrition Research Group, Laboratory of Assessment and Conditioning in Rheumatology, School of Physical Education and Sport, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, University of São Paulo, São Paulo, Brazil.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2019-00074'] 1716,31498467,Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial.,"OBJECTIVES/HYPOTHESIS Voice rest is often prescribed following phonosurgery by most surgeons despite limited empiric evidence to support its practice. This study assessed the effect of postphonosurgery voice rest on vocal outcomes. STUDY DESIGN Prospective, randomized controlled trial. METHODS Patients with unilateral vocal fold lesions undergoing CO 2 laser excision were recruited in a prospective manner and randomized into one of two groups: 1) an experimental arm consisting of 7 days of absolute voice rest, or 2) a control arm consisting of no voice rest. The primary outcome measure was the Voice Handicap Index-10 (VHI-10) questionnaire. Secondary outcomes included aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures. Primary and secondary outcomes were assessed preoperatively and reassessed postoperatively at the 1- and 3-month follow-up. Patient compliance to voice rest instructions were controlled for using subjective and objective parameters. RESULTS Thirty patients were enrolled with 15 randomized to each arm of the study. Statistical analysis for the entire cohort showed a significant improvement in the mean preoperative VHI-10 compared to postoperative assessments at 1-month (19.0 vs. 7.3, P < .05) and 3-month (19.0 vs. 6.2, P < .05) follow-up. However, between-group comparisons showed no significant difference in postoperative VHI-10 at either time point. Similarly, secondary outcome measures yielded no significant difference in between-group comparisons. CONCLUSIONS Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis. LEVEL OF EVIDENCE 1b CLINICAL TRIAL NUMBER: NCT02788435 (clinicaltrials.gov) Laryngoscope, 130:1750-1755, 2020.",2020,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis. ","['Thirty patients were enrolled with 15 randomized to each arm of the study', 'Patients with unilateral vocal fold lesions undergoing CO 2 laser excision', 'vocal fold lesions']","['absolute voice rest, or 2) a control arm consisting of no voice rest', 'postphonosurgery voice rest', 'laser resection']","['postoperative VHI-10', 'Voice Handicap Index-10 (VHI-10) questionnaire', 'mean preoperative VHI-10', 'aerodynamic measurements (maximum phonation time), acoustic measures (fundamental frequency, jitter, shimmer, and harmonic-to-noise ratio), and auditory-perceptual measures']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time (observable entity)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]",30.0,0.185901,"Our study shows no significant benefit to voice rest on postoperative voice outcomes as determined by patient self-perception, acoustic variables, and auditory-perceptual analysis. ","[{'ForeName': 'Sandeep S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Doyle', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Failla', 'Affiliation': 'Voice Production and Perception Laboratory, and Department of Health and Rehabilitation Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hawkins', 'Affiliation': 'Department of Speech-Language Pathology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.'}]",The Laryngoscope,['10.1002/lary.28287'] 1717,31828166,Effectiveness of Dose Adjustment of Insulin in Type 2 Diabetes among Hemodialysis Patients with End-Stage Renal Disease: A Randomized Crossover Study.,"Determining insulin requirements for hemodialysis patients with end-stage renal disease (ESRD) is difficult. We performed a randomized crossover study among type 2 diabetes (T2DM) patients with ESRD on continuous hemodialysis and receiving standard insulin for glycemic control. The patients were randomized in 2 groups: daily insulin needed on the day after hemodialysis and a 25% decrease in daily insulin needed on the day after hemodialysis. A total of 51 T2DM patients with ESRD were enrolled. The adjusted-insulin group had higher plasma glucose levels at the 2nd hour of dialysis than those of the nonadjusted-insulin group. Incidence of hypoglycemia per dialysis session (3.3% vs. 0.7%, P = 0.02) and symptoms related to hypoglycemia (6.9% vs. 0.7%, P = 0.001) were more frequent in the nonadjusted-insulin group. A reduced insulin administration of 25% among T2DM patients undergoing hemodialysis on the day of dialysis was associated with sustained glycemic efficacy and the production of fewer hypoglycemic symptoms. This trial is registered with TCTR20180724002.",2019,"Incidence of hypoglycemia per dialysis session (3.3% vs. 0.7%, P = 0.02) and symptoms related to hypoglycemia (6.9% vs. 0.7%, P = 0.001) were more frequent in the nonadjusted-insulin group.","['type 2 diabetes (T2DM) patients with ESRD on continuous hemodialysis and receiving standard insulin for glycemic control', 'hemodialysis patients with end-stage renal disease (ESRD', '51 T2DM patients with ESRD were enrolled', 'Type 2 Diabetes among Hemodialysis Patients with End-Stage Renal Disease']",['Insulin'],"['hypoglycemic symptoms', 'Incidence of hypoglycemia per dialysis session', 'hypoglycemia', 'sustained glycemic efficacy', 'plasma glucose levels']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0472679', 'cui_str': 'Continuous hemodialysis (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.022963,"Incidence of hypoglycemia per dialysis session (3.3% vs. 0.7%, P = 0.02) and symptoms related to hypoglycemia (6.9% vs. 0.7%, P = 0.001) were more frequent in the nonadjusted-insulin group.","[{'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Singhsakul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok 10400, Thailand.'}, {'ForeName': 'Ouppatham', 'Initials': 'O', 'LastName': 'Supasyndh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok 10400, Thailand.'}, {'ForeName': 'Bancha', 'Initials': 'B', 'LastName': 'Satirapoj', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok 10400, Thailand.'}]",Journal of diabetes research,['10.1155/2019/6923543'] 1718,31828170,Prospective Randomized Controlled Study of Hemostatic Efficacy with Kaolin-Impregnated Dressings in Diabetic Foot Ulcers Taking Anticoagulants Undergoing Debridement in an Outpatient Clinic.,"Background The effective hemostasis after minor debridement in an outpatient clinic is important and essential. This study is aimed at evaluating the hemostatic efficacy and safety of the kaolin-impregnated dressing for diabetic foot ulcer patient who take an anticoagulant. Methods A prospective, randomized, clinical trial study was performed in twenty-six patients with diabetic foot ulcers who take an anticoagulant requiring minor debridement in an outpatient clinic. Minor debridement and removal of break down skin were performed by one orthopedic surgeon. Hemostasis on wound bed was achieved using kaolin-impregnated gauze (study group) and standard sterilized dry gauze (control group). Two randomized groups were compared for hemostatic efficacy and side effect. Results For the purpose of this study, the presence or absence of hemostasis was assessed at 5 and 10 minutes after the application of dressing material. Treatment was evaluated as successful if bleeding was ceased adequately, and no extra hemostatic measures were required within 10 minutes. At 5 minutes, 80% of patients using the kaolin-impregnated gauze successfully achieved complete hemostasis versus 40% in the control group that controlled bleeding partially. With kaolin-impregnated gauze, 100% of patients show complete hemostasis at 10 minutes versus 58.3% in the standard gauze ( P < .001). An adverse effect was not noted in all patients. Conclusions The use of kaolin-impregnated gauze appears to be a safe and feasible option in managing bleeding after debridement of diabetic foot ulcers, and merits to patient who had a bleeding tendency is high. This trial is registered with CRIS registration number KCT0003894.",2019,"At 5 minutes, 80% of patients using the kaolin-impregnated gauze successfully achieved complete hemostasis versus 40% in the control group that controlled bleeding partially.","['diabetic foot ulcer patient who take an anticoagulant', 'Diabetic Foot Ulcers Taking Anticoagulants Undergoing Debridement in an Outpatient Clinic', 'twenty-six patients with diabetic foot ulcers who take an anticoagulant requiring minor debridement in an outpatient clinic']","['kaolin-impregnated gauze (study group) and standard sterilized dry gauze (control group', 'kaolin-impregnated dressing', 'Kaolin-Impregnated Dressings', 'kaolin-impregnated gauze']","['hemostatic efficacy and side effect', 'hemostatic efficacy and safety', 'effective hemostasis', 'complete hemostasis', 'adverse effect', 'successful if bleeding']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]","[{'cui': 'C0022499', 'cui_str': 'Kaolin'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C1272974', 'cui_str': 'Impregnated dressing'}]","[{'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0504237,"At 5 minutes, 80% of patients using the kaolin-impregnated gauze successfully achieved complete hemostasis versus 40% in the control group that controlled bleeding partially.","[{'ForeName': 'Yeok Gu', 'Initials': 'YG', 'LastName': 'Hwang', 'Affiliation': 'Department of Orthopedic Surgery, Ewha Womans University Seoul Hospital, Ewha University College of Medicine, 260, Gonghang-daero, Gangseo-gu, Seoul 07804, Republic of Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Severance Hospital, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.'}, {'ForeName': 'Eun Ae', 'Initials': 'EA', 'LastName': 'Won', 'Affiliation': 'Department of Nursing, Gangnam Severance Hospital, Yonsei University College of Medicine, 211, Eonj-ro, Gangnam-gu, Seoul 06273, Republic of Korea.'}, {'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211, Eonju-ro, Gangnam-gu, Seoul 06273, Republic of Korea.'}]",Journal of diabetes research,['10.1155/2019/9316380'] 1719,31852711,Prospective multicentre open-label randomised controlled trial of 3-month versus 12-month dual antiplatelet therapy after implantation of the new generation biodegradable polymer sirolimus TARGET-eluting coronary stent: protocol of the TARGET DAPT trial.,"INTRODUCTION Dual antiplatelet therapy (DAPT) with aspirin and thienopyridine is required after placement of coronary stents to prevent thrombotic complications. However, current recommendation for duration of DAPT remains controversial. Firehawk is a biodegradable polymer applied to recessed abluminal grooves, sirolimus target-eluting stent associated with early excellent healing response and almost complete strut coverage, as well as possibly reduced myocardial ischaemic events. But the optimal DAPT duration for such a new generation stent is less known. Therefore, the present trial seeks to evaluate the safety and efficacy of 3-month versus 12-month DAPT in broad patients receiving Firehawk stents. METHODS AND ANALYSIS The TARGET DAPT study is designed to access the benefits and risks of short-term (3 months) versus long-term (12 months) DAPT in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention for the treatment of coronary artery obstructive lesions. The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents. The primary endpoint is net adverse clinical and cerebral events, a composite of all-cause death, myocardial infarction, cerebral vascular accident and major bleeding (BARC 2,3 or 5) at 18 months clinical follow-up postindex procedure. ETHICS AND DISSEMINATION Ethics approval was obtained from the Ethics Committee of Zhongshan Hospital, Shanghai. The reference number is B2018-146R. Study findings will be made available to interested participants. Study results will be submitted for publication in a peer-reviewed journal. Also the protocol will be submitted and approved by the institutional Ethics Committee at each participating clinical centre. TRIAL REGISTRATION NCT03008083.",2019,"The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents.","['2446 subjects treated with', 'subjects undergoing percutaneous coronary intervention for the treatment of coronary artery obstructive lesions', 'broad patients receiving Firehawk stents']","['aspirin and thienopyridine', 'DAPT', 'Firehawk stents']","['net adverse clinical and cerebral events, a composite of all-cause death, myocardial infarction, cerebral vascular accident and major bleeding (BARC 2,3 or 5', 'safety and efficacy']","[{'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C3872566', 'cui_str': 'Obstructive lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1120149', 'cui_str': 'thienopyridine'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2446.0,0.131564,"The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents.","[{'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': ""Ji'e"", 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Shanghai MicroPort Medical Group Co, Ltd, Shanghai, China.'}, {'ForeName': 'Ruifen', 'Initials': 'R', 'LastName': 'Cao', 'Affiliation': 'Shanghai MicroPort Medical Group Co, Ltd, Shanghai, China.'}, {'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University; Shanghai Institute of Cardiovascular Diseases, Shanghai, China jbge@zs-hospital.sh.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033774'] 1720,32433648,Pre-injury activity predicts outcomes following distal radius fractures in patients age 60 and older.,"INTRODUCTION One out of every 5 elderly patients will suffer a distal radius fracture and these injuries are often related to poor bone health. Several surgical subspecialties have demonstrated that pre-injury activity level can impact patient outcomes. To determine the importance of physical activity, we examined the relationship between pre-injury activity and patient-reported and functional outcomes among fracture patients. METHODS This is a retrospective analysis of prospectively collected data from participants enrolled in the Wrist and Radius Injury Surgical Trial (WRIST) from April 10, 2012 to December 31, 2016. This study included 304 adults, 60 years or older with isolated unstable distal radius fractures; 187 were randomized to one of three surgical treatments and 117 opted for casting. Participants opting for surgery were randomized to receive volar locking plate, percutaneous pinning, or external fixation. Participants who chose not to have surgery were treated with casting. All participants were stratified prior to analysis into highly and less-active groups based on pre-injury Rapid Assessment of Physical Activity Scores. RESULTS 280 patients had 12-month assessments of outcomes. Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05. Highly active participants demonstrated greater grip strength at the 3-month (p = 0.017) and 6-month (p = 0.007) time-points. Highly active participants treated with volar locking plate scored 10+ points greater on the Michigan Hand Questionnaire compared to the less-active group at the 6-week (p = 0.032), 3-month (p = 0.009) and 12-month (0.004) time points, with an effect size larger than 0.50, suggesting pre-injury level of activity had a significant clinical impact. CONCLUSIONS Higher levels of pre-injury activity are predictive of patient-reported and functional outcomes following distal radius fracture. Because of the greater PROs, the early mobility and lower risk of hardware infection reported in the literature, volar plating is preferable to other treatments for highly active patients who request and meet indications for surgery. TRIAL REGISTRATION clinicaltrials.gov identifier: NCT01589692.",2020,"Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05.","['Participants opting for surgery', '280 patients had 12-month assessments of outcomes', 'fracture patients', 'patients age 60 and older', 'Participants who chose not to have surgery were treated with casting', '304 adults, 60 years or older with isolated unstable distal radius fractures; 187', 'participants enrolled in the Wrist and Radius Injury Surgical Trial (WRIST) from April 10, 2012 to December 31, 2016']","['volar locking plate', 'volar locking plate, percutaneous pinning, or external fixation', 'distal radius fractures']","['Physical Activity Scores', 'grip strength', 'Michigan Hand Questionnaire']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",304.0,0.0768138,"Highly active participants scored 8 and 5 points greater on the Michigan Hand Questionnaire at 6 weeks and 3 months respectively, p<0.05.","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Hooper', 'Affiliation': 'Hand Surgery Fellow, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'PhD Candidate, Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Associate Professor, Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Shauver', 'Affiliation': 'Clinical Research Coordinator, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Chung', 'Affiliation': 'Charles B. G. de Nancrede Professor of Surgery, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232684'] 1721,31354089,"Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial.","Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335 .",2019,"At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001).","['692 patients with acute proximal deep vein thrombosis (DVT) to receive', 'patients with acute proximal DVT']","['pharmacomechanical catheter-directed thrombolysis', 'PCDT', 'anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT', 'Adjunctive Catheter-Directed Thrombolysis']","['Reflux DUS', 'popliteal vein', 'femoral vein', 'valvular reflux prevalence', 'residual thrombus', 'CFV non-compressibility', 'Valvular reflux', 'duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL', 'QOL', 'higher incidence of moderate-or-severe PTS', 'higher rates of any PTS', 'Compression DUS', 'venous valvular reflux']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0032652', 'cui_str': 'Popliteal Vein'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0277919', 'cui_str': 'Venous Stasis Syndrome'}, {'cui': 'C0034380'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}]",692.0,0.198204,"At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001).","[{'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Weinberg', 'Affiliation': 'Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Hadley', 'Affiliation': 'Vascular Ultrasound Core-Laboratory (VasCore), Boston, MA, USA.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'Division of Biostatistics, Washington University in St Louis, St Louis, MO, USA.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St Joseph's Hospital, Orange, CA, USA.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Gornik', 'Affiliation': 'Vascular Center, University Hospitals Harrington Heart & Vascular Institute, Cleveland, OH, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, VA, USA.'}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'Division of Blood Diseases & Resources, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH), Bethesda, MD, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Schainfeld', 'Affiliation': 'Vascular Medicine Section, Cardiology Division, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Angle', 'Affiliation': 'Department of Radiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Misra', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Schor', 'Affiliation': 'Staten Island University Hospital, New York, NY, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Hurst', 'Affiliation': 'Department of Radiology, St Elizabeth Healthcare, Edgewood, KY, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Vascular medicine (London, England)",['10.1177/1358863X19862043'] 1722,31894238,Developing preliminary blood metabolomics-based biomarkers of insufficient sleep in humans.,"STUDY OBJECTIVE Identify small molecule biomarkers of insufficient sleep using untargeted plasma metabolomics in humans undergoing experimental insufficient sleep. METHODS We conducted a cross-over laboratory study where 16 normal weight participants (8 men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9h sleep opportunity per night) followed by five day insufficient (5h sleep opportunity per night) and adequate (9h sleep opportunity per night) sleep conditions. Energy balanced diets were provided during baseline, with ad libitum energy intake provided during the insufficient and adequate sleep conditions. Untargeted plasma metabolomics analyses were performed using blood samples collected every 4h across the final 24h of each condition. Biomarker models were developed using logistic regression and linear support vector machine algorithms. RESULTS The top performing biomarker model was developed by linear support vector machine modeling, consisted of 65 compounds, and discriminated insufficient versus adequate sleep with 74% overall accuracy and a Matthew's Correlation Coefficient of 0.39. The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. CONCLUSION We identified potential metabolomics-based biomarkers of insufficient sleep in humans. Although our current biomarkers require further development and validation using independent cohorts, they have potential to advance our understanding of the negative consequences of insufficient sleep, improve diagnosis of poor sleep health, and could eventually help identify targets for countermeasures designed to mitigate the negative health consequences of insufficient sleep.",2020,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. ","['humans', 'humans undergoing experimental insufficient sleep', '16 normal weight participants (8 men; age 22 ± 5 years; body mass index < 25 kg/m2) completed three baseline days (9h sleep opportunity per night) followed by five day insufficient (5h sleep opportunity per night) and adequate (9h sleep opportunity per night) sleep conditions']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],[],65.0,0.0196736,"The compounds in the top performing biomarker model were associated with ATP Binding Cassette Transporters in Lipid Homeostasis, Phospholipid Metabolic Process, Plasma Lipoprotein Remodeling, and sphingolipid metabolism. ","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Depner', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Dasha T', 'Initials': 'DT', 'LastName': 'Cogswell', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bisesi', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Markwald', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Charmion', 'Initials': 'C', 'LastName': 'Cruickshank-Quinn', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Quinn', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Skaggs School of Pharmacology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Reisdorph', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': 'Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}]",Sleep,['10.1093/sleep/zsz321'] 1723,31746051,"The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial.","To explore the efficacy of regular penis-root masturbation (PRM) versus Kegel exercise (KE) in the treatment of primary premature ejaculation (PPE). This study was a prospective quasi-randomised controlled trial. Thirty-seven heterosexual males with PPE were selected according to the time sequence of outpatient consultations and the preliminary results of a pre-experiment and were assigned to an PRM group and a KE group. Differences in intravaginal ejaculatory latency times (IELTs) and premature ejaculation diagnostic tool (PEDT) scores were compared between the two groups. The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University. Among the 37 PPE patients, 18 performed PRM and 19 patients performed KE. The IELTs of patients who performed PRM and KE were significantly prolonged before treatment, and the difference after treatment was statistically significant (p < .05). Compared with the KE group, the IELT prolongation effect in the PRM group was more significant PRM (p < .05). The PEDT scores of patients after performing PRM and KE were significantly lower than those before performing these exercises (p < .05). Compared with the KE group, the PEDT scores of the PRM group exhibited a greater decrease (p < .05). Thus, both PRM and KE have therapeutic effects on PPE. Compared with KE, PRM is more effective in the treatment of PPE.",2020,"The IELTs of patients who performed PRM and KE were significantly prolonged before treatment, and the difference after treatment was statistically significant (p < .05).","['Thirty-seven heterosexual males with PPE', '37 PPE patients, 18 performed PRM and 19 patients performed KE', 'primary premature ejaculation (PPE', 'primary premature ejaculation']","['KE', 'KE, PRM', 'regular penis-root masturbation (PRM) versus Kegel exercise (KE', 'regular penis-root masturbation, versus Kegel exercise', 'PRM']","['PRM', 'PEDT scores', 'IELT prolongation effect', 'intravaginal ejaculatory latency times (IELTs) and premature ejaculation diagnostic tool (PEDT) scores']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0070932', 'cui_str': 'PPED'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0030851', 'cui_str': 'Penile structure (body structure)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0024906', 'cui_str': 'Masturbation'}, {'cui': 'C0262718', 'cui_str': 'Pelvic muscle exercises'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",18.0,0.0185694,"The IELTs of patients who performed PRM and KE were significantly prolonged before treatment, and the difference after treatment was statistically significant (p < .05).","[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Andrology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Guanqiang', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Huachu', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yunni', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Andrology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}]",Andrologia,['10.1111/and.13473'] 1724,30977089,"Effects of Chromium and Carnitine Co-supplementation on Body Weight and Metabolic Profiles in Overweight and Obese Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial.","The primary aim of our study was to determine the influence of taking chromium plus carnitine on insulin resistance, with a secondary objective of evaluating the influences on lipid profiles and weight loss in overweight subjects with polycystic ovary syndrome (PCOS). In a 12-week randomized, double-blind, placebo-controlled clinical trial, 54 overweight women were randomly assigned to receive either supplements (200 μg/day chromium picolinate plus 1000 mg/day carnitine) or placebo (27/each group). Chromium and carnitine co-supplementation decreased weight (- 3.6 ± 1.8 vs. - 1.0 ± 0.7 kg, P < 0.001), BMI (- 1.3 ± 0.7 vs. - 0.3 ± 0.3 kg/m 2 , P < 0.001), fasting plasma glucose (FPG) (- 5.1 ± 6.0 vs. - 1.1 ± 4.9 mg/dL, P = 0.01), insulin (- 2.0 ± 1.4 vs. - 0.2 ± 1.2 μIU/mL, P < 0.001), insulin resistance (- 0.5 ± 0.4 vs. - 0.04 ± 0.3, P < 0.001), triglycerides (- 18.0 ± 25.2 vs. + 5.5 ± 14.4 mg/dL, P < 0.001), total (- 17.0 ± 20.3 vs. + 3.6 ± 12.0 mg/dL, P < 0.001), and LDL cholesterol (- 13.3 ± 19.2 vs. + 1.4 ± 13.3 mg/dL, P = 0.002), and elevated insulin sensitivity (+ 0.007 ± 0.005 vs. + 0.002 ± 0.005, P < 0.001). In addition, co-supplementation upregulated peroxisome proliferator-activated receptor gamma (P = 0.02) and low-density lipoprotein receptor expression (P = 0.02). Overall, chromium and carnitine co-supplementation for 12 weeks to overweight women with PCOS had beneficial effects on body weight, glycemic control, lipid profiles except HDL cholesterol levels, and gene expression of PPAR-γ and LDLR. Clinical trial registration number: http://www.irct.ir: IRCT20170513033941N38.",2020,"In addition, co-supplementation upregulated peroxisome proliferator-activated receptor gamma (P = 0.02) and low-density lipoprotein receptor expression (P = 0.02).","['54 overweight women', 'overweight subjects with polycystic ovary syndrome (PCOS', 'Overweight and Obese Women with Polycystic Ovary Syndrome']","['Chromium and carnitine co-supplementation', 'placebo', 'chromium and carnitine co-supplementation', 'Placebo', 'supplements (200\xa0μg/day chromium picolinate plus 1000\xa0mg/day carnitine) or placebo', 'Chromium and Carnitine Co-supplementation', 'chromium plus carnitine']","['triglycerides', 'BMI', 'insulin resistance', 'low-density lipoprotein receptor expression', 'Body Weight and Metabolic Profiles', 'lipid profiles and weight loss', 'fasting plasma glucose (FPG', 'LDL cholesterol', 'peroxisome proliferator-activated receptor gamma', 'elevated insulin sensitivity', 'body weight, glycemic control, lipid profiles except HDL cholesterol levels, and gene expression of PPAR-γ and LDLR', 'weight']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0034821', 'cui_str': 'Lipoprotein LDL Receptors'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0166417', 'cui_str': 'PPAR gamma'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",54.0,0.686704,"In addition, co-supplementation upregulated peroxisome proliferator-activated receptor gamma (P = 0.02) and low-density lipoprotein receptor expression (P = 0.02).","[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'Gametogenesis Research Center, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kavossian', 'Affiliation': 'Gametogenesis Research Center, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Mersedeh', 'Initials': 'M', 'LastName': 'Kia', 'Affiliation': 'Department of Midwifery, Gorgan Branch, Islamic Azad University, Gorgan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Biological trace element research,['10.1007/s12011-019-01720-8'] 1725,31486407,A Mobile Phone App Designed to Support Weight Loss Maintenance and Well-Being (MotiMate): Randomized Controlled Trial.,"BACKGROUND Few people successfully maintain lost weight over the longer term. Mobile phones have the potential to deliver weight loss management programs that can encourage self-monitoring while also providing some behavioral therapy to assist users in developing personal skills that may be necessary for improved longer term weight loss maintenance. OBJECTIVE The aim of this study was to evaluate a program supporting weight maintenance, which uses a behaviorally based mobile phone app to manage weight, food, exercise, mood, and stress. METHODS In a randomized controlled trial over 24 weeks, the full version of the app (MotiMate) was compared with a control app (monitoring only; excluding mood and stress) for its effect on weight, diet, and psychological well-being. Both apps had the same visual appearance and were designed to deliver all intervention content without face-to-face contact. The control version included features to track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features. The intervention app included more persuasive and interactive features to help users track their weight, food intake, and physical activity and prompted users to enter data each day through notifications and included a mood and stress workshopping tool. Participants were recruited through advertising and existing databases. Clinic visits occurred at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. At all visits, the clinical trial manager recorded body weight, and participants then completed a computer-delivered survey, which measured psychological and lifestyle outcomes. Objective app usage data were recorded throughout the trial. RESULTS A total of 88 adults who had lost and maintained at least 5% of their body weight within the last 2 years were randomized (45 MotiMate and 43 control). Overall, 75% (66/88) were female, and 69% (61/88) completed week 24 with no differences in dropout by condition (χ 2 1,87 =0.7, P=.49). Mixed models suggested no significant changes in weight or psychological outcomes over 24 weeks regardless of condition. Of 61 completers, 53% (32/61) remained within 2% of their starting weight. Significant increases occurred over 24 weeks for satisfaction with life and weight loss self-efficacy regardless of app condition. Diet and physical activity behaviors did not vary by app or week. Negative binomial models indicated that those receiving the full app remained active users of the app for 46 days longer than controls (P=.02). Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). CONCLUSIONS Although some aspects of the intervention app such as usage and user feedback showed promise, there were few observable effects on behavioral and psychological outcomes. Future evaluation of the app should implement alternative research methods or target more specific populations to better understand the utility of the coping interface. TRIAL REGISTRATION Australia New Zealand Clinical Trials Registry ACTRN12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120.",2019,"Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). ",['88 adults who had lost and maintained at least 5% of their body weight within the last 2 years'],[],"['track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features', 'weight or psychological outcomes', 'Diet and physical activity behaviors', 'satisfaction with life and weight loss self-efficacy', 'Clinic visits', 'Support Weight Loss Maintenance and Well-Being (MotiMate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",88.0,0.146508,"Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). ","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brindal', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Adelaide, Australia.'}, {'ForeName': 'Gilly A', 'Initials': 'GA', 'LastName': 'Hendrie', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Adelaide, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Freyne', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Epping, Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Health and Biosecurity, Commonwealth Scientific and Industrial Research Organisation, Adelaide, Australia.'}]",JMIR mHealth and uHealth,['10.2196/12882'] 1726,31858966,Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT.,"BACKGROUND Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. OBJECTIVES The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. DESIGN This was a three-arm, single-blind, parallel randomised controlled trial. SETTING A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. PARTICIPANTS A total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. INTERVENTIONS The intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. RANDOMISATION Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. MAIN OUTCOME MEASURES The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. RESULTS The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. CONCLUSIONS Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. TRIAL REGISTRATION Current Controlled Trials ISRCTN84864870. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.",2019,"At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI)","['adults with high cardiovascular risk', 'A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited.\nPARTICIPANTS\n\n\nA total of 1742 participants aged 40-74 years with a ≥\u200920.0% risk of a CVD event in the following 10 years were randomised', 'patients at high risk of CVD in group settings versus', 'The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white']","['Enhanced motivational interviewing', 'enhanced lifestyle motivational interviewing intervention', 'individual settings and usual care (UC', 'Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs', 'integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators', 'UC']","['clinical effectiveness and cost-effectiveness', 'cost-effective', 'weight and increasing physical activity', 'weight and increasing physical activity (PA', 'changes in low-density lipoprotein cholesterol and CVD risk score', 'reductions in weight', 'change in weight (kg) from baseline and change in PA', 'reducing weight', 'PA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",1742.0,0.123281,"At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI)","[{'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Twist', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Department of Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'de Zoysa', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Health Services and Population Research, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23690'] 1727,31489842,Effects of Mobile Health Prompts on Self-Monitoring and Exercise Behaviors Following a Diabetes Prevention Program: Secondary Analysis From a Randomized Controlled Trial.,"BACKGROUND A number of mobile health (mHealth) apps exist that focus specifically on promoting exercise behavior. To increase user engagement, prompts, such as text messages, emails, or push notifications, are often used. To date, little research has been done to understand whether, and for how long, these prompts influence exercise behavior. OBJECTIVE This study aimed to assess the impact of prompts on mHealth self-monitoring and self-reported exercise in the days following a prompt and whether these effects differ based on exercise modality. METHODS Of the possible 99 adults at risk for developing type II diabetes who participated in a diabetes prevention program, 69 were included in this secondary analysis. Participants were randomly assigned to 1 of the following 2 exercise conditions: high-intensity interval training or moderate-intensity continuous training. In the year following a brief, community-based diabetes prevention program involving counseling and supervised exercise sessions, all participants self-monitored their daily exercise behaviors on an mHealth app in which they were sent personalized prompts at varying frequencies. mHealth self-monitoring and self-reported exercise data from the app were averaged over 1, 3, 5, and 7 days preceding and following a prompt and subsequently compared using t tests. RESULTS In the year following the diabetes prevention program, self-monitoring (t 68 =6.82; P<.001; d=0.46) and self-reported exercise (t 68 =2.16; P=.03; d=0.38) significantly increased in the 3 days following a prompt compared with the 3 days preceding. Prompts were most effective in the first half of the year, and there were no differences in self-monitoring or self-reported exercise behaviors between exercise modalities (P values >.05). In the first half of the year, self-monitoring was significant in the 3 days following a prompt (t 68 =8.61; P<.001; d=0.60), and self-reported exercise was significant in the 3 days (t 68 =3.7; P<.001; d=0.37), 5 days (t 67 =2.15; P=.04; d=0.14), and 7 days (t 68 =2.46; P=.02; d=0.15) following a prompt, whereas no significant changes were found in the second half of the year. CONCLUSIONS This study provides preliminary evidence regarding the potential influence of prompts on mHealth self-monitoring and self-reported exercise and the duration for which prompts may be effective as exercise behavior change tools. Future studies should determine the optimal prompting frequency for influencing self-reported exercise behaviors. Optimizing prompt frequency can potentially reduce intervention costs and promote user engagement. Furthermore, it can encourage consumers to self-monitor using mHealth technology while ensuring prompts are sent when necessary and effective. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR2-10.2196/11226.",2019,"Prompts were most effective in the first half of the year, and there were no differences in self-monitoring or self-reported exercise behaviors between exercise modalities (P values >.05).","['99 adults at risk for developing type II diabetes who participated in a diabetes prevention program, 69 were included in this secondary analysis']","['exercise conditions: high-intensity interval training or moderate-intensity continuous training', 'community-based diabetes prevention program involving counseling and supervised exercise sessions', 'Mobile Health']","['self-monitoring or self-reported exercise behaviors', 'Self-Monitoring and Exercise Behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",99.0,0.0431438,"Prompts were most effective in the first half of the year, and there were no differences in self-monitoring or self-reported exercise behaviors between exercise modalities (P values >.05).","[{'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'MacPherson', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Kohle J', 'Initials': 'KJ', 'LastName': 'Merry', 'Affiliation': 'Mechatronic Systems Engineering, School of Engineering Science, Simon Fraser University, Surrey, BC, Canada.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Locke', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Jung', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/12956'] 1728,31250540,Efficacy of two different doses of oral vitamin D supplementation on inflammatory biomarkers and maternal and neonatal outcomes.,"Hypovitaminosis D during pregnancy is suggested to have a link with complications in both mother and infant. We aimed to evaluate the efficacy of two doses of vitamin D3 supplementation during pregnancy on maternal and cord blood vitamin D status, inflammatory biomarkers, and maternal and neonatal outcomes. A total of 84 pregnant women (gestational age of <12 weeks) were randomly allocated to one of two groups: (a) 1,000-IU/d vitamin D and (b) 2,000 IU/d. Biochemical assessments (25-hydroxycalciferol (25(OH)D), hs-CRP, and cell-culture supernatant concentrations of IL-1β, IL-6, and TNF-α) of mothers were performed at the beginning and 34 weeks of gestation. Assessments of infants at delivery comprised cord blood serum concentrations of 25(OH)D, hs-CRP, IL-1β, IL-6, TNF-α, birth sizes, and Apgar score. Circulating concentrations of 25(OH)D increased in both intervention groups with more increment in 2,000 IU/d than in 1,000 IU/d (46.7 ± 30.7 vs. 24.0 ± 21.07 nmol L -1 , P = .001). Concentrations of TNF-α decreased significantly in group 2,000 (-913.1 ± 1261.3 ng L -1 , P = .01). The cord blood concentration of IL-6 in group 2,000 IU/d, compared with 1,000 IU/d, was significantly lower (25.9 ± 32.0 vs. 4.6 ± 1.4 ng L -1 , P = .03). The birth sizes including weight, length, and head circumference of the infants of group 2,000 IU/d were significantly higher than the infants' of group 1,000 IU/d. Supplementation with 2,000-IU/d vitamin D3 is more effective than 1,000 IU/d in pregnant women in terms of increasing circulating 25(OH)D, ameliorating pro-inflammatory markers notably TNF-α in mother and IL-6 in cord blood, and improving neonatal outcomes including the birth sizes.",2019,"Concentrations of TNF-α decreased significantly in group 2000 (-913.1±1261.3 ng/L, p=0.01).","['84 pregnant women (gestational age of <12 weeks', 'pregnant women']","['oral vitamin D supplementation', 'd vitamin D3', 'vitamin D3 supplementation']","['Biochemical assessments (25-hydroxycalciferol (25(OH)D), hs-CRP and cell-culture supernatant concentrations of IL-1β, IL-6 and TNF-α', 'maternal and cord blood vitamin D status, inflammatory biomarkers and maternal and neonatal outcomes', 'cord blood concentration of IL-6', 'Circulating concentrations of 25(OH)D', 'cord blood serum concentrations of 25(OH)D, hs-CRP, IL-1β, IL-6, TNF-α, birth sizes and Apgar score', 'weight, length and head circumference', 'Concentrations of TNF-α', 'inflammatory biomarkers, and maternal and neonatal outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0000343', 'cui_str': '25-Hydroxycalciferol'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture Techniques'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]",84.0,0.0958387,"Concentrations of TNF-α decreased significantly in group 2000 (-913.1±1261.3 ng/L, p=0.01).","[{'ForeName': 'Soudabe', 'Initials': 'S', 'LastName': 'Motamed', 'Affiliation': 'Department of Nutrition, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Maternal & child nutrition,['10.1111/mcn.12867'] 1729,31402321,"Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND Endocrine therapy-based neoadjuvant treatment for luminal breast cancer allows efficient testing of new combinations before surgery. The activation of the phosphatidylinositol-3-kinase (PI3K) pathway is a known mechanism of resistance to endocrine therapy. Taselisib is an oral, selective PI3K inhibitor with enhanced activity against PIK3CA-mutant cancer cells. The LORELEI trial tested whether taselisib in combination with letrozole would result in an increased proportion of objective responses and pathological complete responses. METHODS In this multicentre, randomised, double-blind, parallel-cohort, placebo-controlled phase 2, study, we enrolled postmenopausal women (aged ≥18 years) with histologically confirmed, oestrogen receptor (ER)-positive, HER2-negative, stage I-III, operable breast cancer, from 85 hospitals in 22 countries worldwide. To be eligible, patients had have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1, adequate organ function, and had to have evaluable tumour tissue for PIK3CA genotyping. Patients were randomly assigned (1:1) by means of a permuted block algorithm (block size of four) via an interactive voice or web-based response system, to receive letrozole (2·5 mg/day orally, continuously) with either 4 mg of oral taselisib or placebo (on a 5 days-on, 2 days-off schedule) for 16 weeks, followed by surgery. Randomisation was stratified by tumour size and nodal status. Site staff, patients, and the sponsor were masked to treatment assignment. Coprimary endpoints were the proportion of patients who achieved an objective response by centrally assessed breast MRI and a locally assessed pathological complete response in the breast and axilla (ypT0/Tis, ypN0) at surgery in all randomly assigned patients and in patients with PIK3CA-mutant tumours. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02273973, and is closed to accrual. FINDINGS Between Nov 12, 2014, and Aug 12, 2016, 334 participants were enrolled and randomly assigned to receive letrozole and placebo (n=168) or letrozole and taselisib (n=166). Median follow-up was 4·9 months (IQR 4·7-5·1). The study met one of its primary endpoints: the addition of taselisib to letrozole was associated with a higher proportion of patients achieving an objective response in all randomly assigned patients (66 [39%] of 168 patients in the placebo group vs 83 [50%] of 166 in the taselisib group; odds ratio [OR] 1·55, 95% CI 1·00-2·38; p=0·049) and in the PIK3CA-mutant subset (30 [38%] of 79 vs 41 [56%] of 73; OR 2·03, 95% CI 1·06-3·88; p=0·033). No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48). The most common grade 3-4 adverse events in the taselisib group were gastrointestinal (13 [8%] of 167 patients), infections (eight [5%]), and skin-subcutaneous tissue disorders (eight [5%]). In the placebo group, four (2%) of 167 patients had grade 3 or worse vascular disorders, two (1%) had gastrointestinal disorders, and two (1%) patients had grade 3 or worse infections and infestations. There was no grade 4 hyperglycaemia and grade 3 cases were asymptomatic. Serious adverse events were more common in the taselisib group (eight [5%] patients with infections and seven [4%] with gastrointestinal effects) than in the placebo group (one [1%] patient each with grade 3 postoperative wound and haematoma infection, grade 4 hypertensive encephalopathy, grade 3 acute cardiac failure, and grade 3 breast pain). One death occurred in the taselisib group, which was not considered to be treatment-related. INTERPRETATION The increase in the proportion of patients who achieved an objective response from the addition of taselisib to endocrine therapy in a neoadjuvant setting is consistent with the clinical benefit observed in hormone receptor-positive, HER2-negative, metastatic breast cancer. FUNDING Genentech and F Hoffmann-La Roche.",2019,"No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48).","['postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI', 'enrolled postmenopausal women (aged ≥18 years) with histologically confirmed, oestrogen receptor (ER)-positive, HER2-negative, stage I-III, operable breast cancer, from 85 hospitals in 22 countries worldwide', 'Between Nov 12, 2014, and Aug 12, 2016, 334 participants', 'patients had have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1, adequate organ function, and had to have evaluable tumour tissue for PIK3CA genotyping']","['letrozole and placebo', 'placebo', 'Neoadjuvant letrozole plus taselisib versus letrozole plus placebo', 'letrozole', 'Endocrine therapy-based neoadjuvant treatment', 'letrozole and taselisib', 'permuted block algorithm (block size of four) via an interactive voice or web-based response system, to receive letrozole (2·5 mg/day orally, continuously) with either 4 mg of oral taselisib or placebo']","['grade 3 postoperative wound and haematoma infection, grade 4 hypertensive encephalopathy, grade 3 acute cardiac failure, and grade 3 breast pain', 'One death', 'objective response', 'grade 3 or worse infections and infestations', 'proportion of objective responses and pathological complete responses', 'Serious adverse events', 'pathological complete response', 'grade 3 or worse vascular disorders', 'gastrointestinal disorders', 'proportion of patients who achieved an objective response by centrally assessed breast MRI and a locally assessed pathological complete response in the breast and axilla (ypT0/Tis, ypN0', 'skin-subcutaneous tissue disorders']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4053731'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002045'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0948087', 'cui_str': 'Haematoma infection'}, {'cui': 'C0151620', 'cui_str': 'Hypertensive Encephalopathy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0009450', 'cui_str': 'Infectious Diseases'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0278403', 'cui_str': 'Tela Subcutanea'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",334.0,0.665998,"No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain. Electronic address: csaura@vhio.net.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Hlauschek', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Zardavas', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrence, NJ, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Jallitsch-Halper', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'de la Peña', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ballestrero', 'Affiliation': 'University of Genoa - Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Policlinico San Martino, Genova; Gruppo Oncologico Italiano di Ricerca Clinica, Genova, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dubsky', 'Affiliation': 'Medical University of Vienna, Vienna, Austria; Hirslanden Klinik St Anna, Breast Centre, Lucerne, Switzerland.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Lombard', 'Affiliation': 'Breast Cancer Trials Australia New Zealand, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Breast Cancer Group, CHU Namur, Université Catholique de Louvain, Ottignies-Nouvain-la-Neuve, Belgium.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Castaneda', 'Affiliation': 'Grupo de Estudios Clinicos Oncologicos Peruano, Lima, Perú.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico and International Breast Cancer Study Group, Milan, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Santos Borges', 'Affiliation': 'Centro de Novos Tratamentos Itajaí, Itajaí, Brazil.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fornier', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Boer', 'Affiliation': 'Szent Margit Hospital, Budapest, Hungary.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Wilson', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stout', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Jerry Y', 'Initials': 'JY', 'LastName': 'Hsu', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Breast International Group, Brussels, Belgium; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria; Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30334-1'] 1730,31331699,"Pazopanib or methotrexate-vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study.","BACKGROUND Desmoid tumours are locally aggressive tumours associated with substantial morbidity. No systemic treatments are approved for this disease, with methotrexate-vinblastine the only chemotherapy regimen assessed in a clinical trial setting to date. VEGF overexpression is a common feature in aggressive desmoid tumours. Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases. We aimed to assess antitumour activity and safety of targeted therapy or combination chemotherapy in progressive desmoid tumours. METHODS DESMOPAZ was a non-comparative, randomised, open-label, phase 2 trial conducted at 12 centres from the French Sarcoma Group. We enrolled adults (≥18 years) with progressive desmoid tumours, normal organ function and centrally documented progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1 based on two imaging assessments obtained within less than a 6-month interval. Participants were randomly assigned (2:1) to oral pazopanib 800 mg per day for up to 1 year or to an intravenous regimen combining vinblastine (5 mg/m 2 per dose) and methotrexate (30 mg/m 2 per dose), administered weekly for 6 months and then every other week for 6 months. Randomisation was stratified according to inclusion centre and tumour location. The primary endpoint was the proportion of patients who had not progressed at 6 months in the first 43 patients who had received one complete or two incomplete cycles of pazopanib. This endpoint was also assessed as a prespecified exploratory endpoint in all patients who had received one complete or two incomplete cycles of methotrexate-vinblastane. Safety analyses were done for all patients who received at least one dose of allocated treatment. This trial was registered with ClinicalTrials.gov, number NCT01876082. FINDINGS From Dec 4, 2012, to Aug 18, 2017, 72 patients were enrolled and randomly assigned (n=48 in the pazopanib group; n=24 in the methotrexate-vinblastine group). Median follow-up was 23·4 months (IQR 17·1-25·5). 46 patients in the pazopanib group and 20 patients in the methotrexate-vinblastine group were assessable for activity. In the first 43 patients assessable for the primary endpoint in the pazopanib group, the proportion of patients who had not progressed at 6 months was 83·7% (95% CI 69·3-93·2). The proportion of patients treated with methotrexate-vinblastine who had not progressed at 6 months was 45·0% (95% CI 23·1-68·5). The most common grade 3 or 4 adverse events in the pazopanib group were hypertension (n=10, 21%) and diarrhoea (n=7, 15%) and in the methotrexate-vinblastine group were neutropenia (n=10, 45%) and liver transaminitis (n=4, 18%). 11 patients (23%) had at least one serious adverse event related to study treatment in the pazopanib group, as did and six patients (27%) in the methotrexate-vinblastine group. INTERPRETATION Pazopanib has clinical activity in patients with progressive desmoid tumours and could be a valid treatment option in this rare and disabling disease. FUNDING GlaxoSmithKline and Novartis.",2019,"Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases.","['From Dec 4, 2012, to Aug 18, 2017, 72 patients were enrolled and randomly assigned (n=48 in the pazopanib group; n=24 in the', 'patients with progressive desmoid tumours', 'adult patients with progressive desmoid tumours (DESMOPAZ', 'enrolled adults (≥18 years) with progressive desmoid tumours, normal organ function and centrally documented progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1 based on two imaging assessments obtained within less than a 6-month interval', '12 centres from the French Sarcoma Group', 'progressive desmoid tumours', '46 patients in the pazopanib group and 20 patients in the']","['combination chemotherapy', 'pazopanib', 'vinblastine', 'methotrexate', 'Pazopanib or methotrexate-vinblastine combination chemotherapy', 'oral pazopanib', 'methotrexate-vinblastane', 'methotrexate-vinblastine', 'Pazopanib']","['activity', 'diarrhoea', 'serious adverse event', 'neutropenia', 'antitumour activity and safety', 'hypertension', 'proportion of patients who had not progressed', 'liver transaminitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0079218', 'cui_str': 'Desmoid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C2242708', 'cui_str': 'Transaminitis'}]",72.0,0.205538,"Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases.","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Toulmonde', 'Affiliation': 'Department of Medicine, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pulido', 'Affiliation': 'Clinical and Epidemiology Department and Clinical Investigation Centre, INSERM, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Department of Medicine, Centre George-Francois Leclerc, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Department of Medicine, Oncopole, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Department of Medicine, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': ""Department of Medicine, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Department of Medicine, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': 'Department of Medicine, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbe', 'Affiliation': 'Department of Dermatology, Hôpital Saint-Louis, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Soulie', 'Affiliation': ""Department of Medicine, Institut de Cancérologie de l'Ouest, Angers, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Piperno-Neumann', 'Affiliation': 'Department of Medicine, Institut Curie, Paris, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sweet', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hembrough', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiology Department and Clinical Investigation Centre, INSERM, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Kind', 'Affiliation': 'Department of Radiology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Crombe', 'Affiliation': 'Department of Radiology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Lucchesi', 'Affiliation': 'Bioinformatics Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Le Loarer', 'Affiliation': 'Department of Pathology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Department of Medicine, Institut Bergonié, Bordeaux, France; University of Bordeaux, Bordeaux, France. Electronic address: a.italiano@bordeaux.unicancer.fr.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30276-1'] 1731,2041004,Psychomotor and clinical assessment of flumazenil as an antagonist of midazolam.,"The benzodiazepine antagonist flumazenil (0.01 mg/kg) has been compared with doxapram (1 mg/kg) and saline for the reversal of anaesthesia with intravenous midazolam, alfentanil, nitrous oxide in oxygen and isoflurane. The completeness of reversal was assessed by means of a four-choice reaction time test, 1 and 3 h following the antagonist. In addition, the level of sedation was graded using a five-point scale. Psychomotor testing showed that 60 min after administration of the antagonist, there were marked increases in reaction times (P less than 0.05) both in the control and doxapram groups, but not in those receiving flumazenil. At 180 min, however, reaction times in all groups had returned to baseline values. In contrast, there was a significant difference in the sedation scores between the saline and flumazenil groups throughout the study period (P less than 0.05). During the 4 h following midazolam, there was no evidence of re-sedation in any of the groups despite the relatively high midazolam dosage.",1991,"During the 4 h following midazolam, there was no evidence of re-sedation in any of the groups despite the relatively high midazolam dosage.",[],"['flumazenil', 'doxapram', 'midazolam, alfentanil, nitrous oxide in oxygen and isoflurane', 'midazolam', 'benzodiazepine antagonist flumazenil']","['reaction times', 're-sedation', 'level of sedation', 'sedation scores']",[],"[{'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0013084', 'cui_str': 'Doxapram'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0668255,"During the 4 h following midazolam, there was no evidence of re-sedation in any of the groups despite the relatively high midazolam dosage.","[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Bill', 'Affiliation': ""Department of Anaesthetics, Queen's University of Belfast.""}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Fee', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Clarke', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1732,31437754,"Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management.","BACKGROUND Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been associated with grade III pyrexia or photosensitivity depending on the combination used. The objective of this study was to fully describe adverse events from the COLUMBUS study evaluating the most recent BRAF/MEK inhibitor combination encorafenib+binimetinib. PATIENTS AND METHODS Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma were randomised to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily or vemurafenib 960 mg twice daily. Adverse events that represent known effects of available BRAFi and/or MEKi were evaluated. RESULTS The safety population included a total of 570 patients (encorafenib+binimetinib = 192; encorafenib = 192; vemurafenib = 186). Median duration of exposure was longer with encorafenib+binimetinib (51 weeks) than with encorafenib (31 weeks) or vemurafenib (27 weeks). Common BRAFi/MEKi toxicities with encorafenib+binimetinib were generally manageable, reversible and infrequently associated with discontinuation. Pyrexia was less frequent with encorafenib+binimetinib (18%) and encorafenib (16%) than with vemurafenib (30%) and occurred later in the course of therapy with encorafenib+binimetinib (median time to first onset: 85 days versus 2.5 days and 19 days, respectively). The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%). The incidence of serous retinopathy was higher with encorafenib+binimetinib (20%) than with encorafenib (2%) or vemurafenib (2%), but no patients discontinued encorafenib+binimetinib because of this event. CONCLUSION Encorafenib+binimetinib is generally well tolerated and has a low discontinuation rate in patients with BRAFV600-mutant melanoma, with a distinct safety profile as compared with other anti-BRAF/MEK targeted therapies. TRIAL REGISTRATION ClinicalTrials.gov (Identifier: NCT01909453) and with EudraCT (number 2013-001176-38).",2019,The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%).,"['Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma', '570 patients (encorafenib+binimetinib\xa0=\xa0192; encorafenib\xa0=\xa0192; vemurafenib\xa0=\xa0186', 'patients with BRAFV600-mutant melanoma']","['encorafenib+binimetinib', 'encorafenib 450\xa0mg once daily plus binimetinib 45\xa0mg twice daily, encorafenib 300\xa0mg once daily\xa0or vemurafenib 960', 'Encorafenib+binimetinib', 'EudraCT', 'encorafenib', 'vemurafenib', 'BRAF/MEK inhibitor (BRAFi/MEKi) therapy']","['Pyrexia', 'incidence of serous retinopathy', 'incidence of photosensitivity', 'Median duration of exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}]","[{'cui': 'C4079208', 'cui_str': 'encorafenib'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0349506', 'cui_str': 'Photosensitization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",570.0,0.142337,The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%).,"[{'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gogas', 'Affiliation': 'Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon Hospital, Athens, Greece. Electronic address: helgogas@gmail.com.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zürich Skin Cancer Center and University Zürich, Zürich, Switzerland.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma Unit, Cancer Immunotherapy and Innovative Therapies, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Dermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany, and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Krajsova', 'Affiliation': 'Department of Dermato-oncology, University Hospital Prague and Charles University First Medical Faculty, Prague, Czech Republic.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Department of Dermatology and Allergy, Skin Cancer Center Hannover, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Vanna Chiarion', 'Initials': 'VC', 'LastName': 'Sileni', 'Affiliation': 'Melanoma Cancer Unit, Oncology Institute of Veneto IRCCS, Padua, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Department of Oncologic Dermatology, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Jan Willem B', 'Initials': 'JWB', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, Isala, Zwolle, Netherlands.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Gollerkeri', 'Affiliation': 'Array BioPharma Inc., Boulder, CO, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pickard', 'Affiliation': 'Array BioPharma Inc., Boulder, CO, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Service of Dermatology, Department of Medicine and Paris-Sud University, Gustave Roussy, Villejuif, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.016'] 1733,31473598,"Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial.","OBJECTIVE To evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China. METHODS We conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome. RESULTS Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes. CONCLUSIONS The EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians. TRIAL REGISTRATION NUMBER ChiCTR-TRC-14004169.",2020,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","['insured patients with mild primary hypertension', 'two primary care centres in Shenzhen, a metropolitan city in China', 'insured patients with mild hypertension in China', 'Two hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively', 'Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs']","['individualised (EBI) counselling', 'individualised counselling']","['adherence rate', 'rate of medication use', '10-year CVD risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",210.0,0.163999,"At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36).","[{'ForeName': 'Mengyang', 'Initials': 'M', 'LastName': 'Di', 'Affiliation': 'Department of Medicine, Rhode Island Hospital, Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zuyao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Shuiming', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Longgang Center for Disease Control and Prevention, Shenzhen, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': ""Central City Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Kunhua', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': ""Ziwei Garden Community Healthcare Centre, Longgang People's Hospital, Shenzhen, China.""}, {'ForeName': 'Jinling', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Division of Epidemiology, School of Public Health and Primary Care, Chinese University of Hong Kong, New Territories, Hong Kong jltang@cuhk.edu.hk.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2019-111197'] 1734,31473510,Temporal changes in postprandial blood transcriptomes reveal subject-specific pattern of expression of innate immunity genes after a high-fat meal.,"White blood cells are among the first responders to dietary components and their metabolites absorbed from the gut. The objective of this study was to determine the whole blood transcriptome response to high-fat challenge meals. A total of 45 fasting and postprandial (3-h and 6-h) whole blood transcriptomes from 5 subjects in a crossover intervention trial of a high-fat meal supplemented with placebo, blueberry powder or docosahexaenoic acid (DHA) were analyzed using RNA sequencing. Select target genes were validated by quantitative reverse-transcription polymerase chain reaction in 180 samples from 20 subjects. The largest contributor to variance was the subject (13,856 genes differentially expressed), followed by the subject on a specific day (2276 genes), followed by the subject's postprandial response (651 genes). After determining the nonsignificance of individual dietary treatments (blueberry, DHA, placebo), treatments were used as replicates to examine postprandial responses to a high-fat meal. The universal postprandial response (95 genes) was associated with lipid utilization, fatty acid beta-oxidation and circadian rhythms. Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components. Genes involved in innate immune responses are differentially expressed in a subject-specific and time-dependent manner in response to the high-fat meals. These genes can serve as biomarkers to assess individual responsiveness to a high-fat diet in inducing postprandial inflammation. Furthermore, the dynamic temporal change in gene expression in postprandial blood suggests that monitoring these genes at multiple time points is necessary to reveal responders to dietary intervention.",2019,"Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components.",[],"['45 fasting and postprandial (3-h and 6-h) whole blood transcriptomes', 'placebo, blueberry powder or docosahexaenoic acid (DHA', 'individual dietary treatments (blueberry, DHA, placebo']","['lipid utilization, fatty acid beta-oxidation and circadian rhythms', 'universal postprandial response']",[],"[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}]",,0.0144234,"Subject-specific postprandial responses were enriched for genes involved in the innate immune response, particularly those of pattern recognition receptors and their downstream signaling components.","[{'ForeName': 'Danielle G', 'Initials': 'DG', 'LastName': 'Lemay', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616; Genome Center, University of California-Davis, 451 Health Sciences Dr., Davis, CA 95616. Electronic address: Danielle.Lemay@usda.gov.'}, {'ForeName': 'Shurong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Shurong.Huang@usda.gov.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: Liping.Huang@usda.gov.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Alkan', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Zeynep.Alkan@usda.gov.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kirschke', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: Catherine.Kirschke@usda.gov.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Burnett', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: Dustin.Burnett@usda.gov.'}, {'ForeName': 'Yining E', 'Initials': 'YE', 'LastName': 'Wang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616. Electronic address: yewang@ucdavis.edu.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Hwang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616; Department of Nutrition, University of California-Davis, One Shields Avenue, Davis, CA, 95616. Electronic address: dhhwang@ucdavis.edu.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.06.007'] 1735,32097286,Physical Activity in Healthcare Workers With Low Back Pain: Effects of the Back-FIT Randomized Trial.,"OBJECTIVE To evaluate the effects of physical activity program in healthcare workers with low back pain (LBP). METHODS A group of healthcare workers participated voluntarily to a meeting about LBP and to be accepted, were randomly allocated to workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website. Both programs consisted in 7 weeks of moderate intensity exercises adapted to LBP. RESULTS Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02). CONCLUSIONS Regular physical exercise, at home or at the workplace among healthcare workers with LBP, represents a great opportunity to improve health and reduce disability.",2020,"RESULTS Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02). ","['Healthcare Workers with Low Back Pain', 'A group of healthcare workers participated voluntarly to a meeting about LBP and to be accepted', 'healthcare workers with low back pain (LBP']","['Physical Activity program', 'workplace program or to home-based exercises, illustrated in a booklet and in a video available on the company intranet website', 'Regular physical exercise']","['Physical Activity', 'Oswestry Disability Index']","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0600191', 'cui_str': 'Intranets'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",,0.0569118,"RESULTS Most outcomes improved in both groups, however with larger improvement of the Oswestry Disability Index in the workplace group (P = 0.02). ","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Bernardelli', 'Affiliation': ""Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy (Dr Bernardelli, Dr Colonna); Occupational Health Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Dr Vigna, Dr Nava, Dr Consonni, Dr Riboldi); National Research Centre for the Working Environment, Copenhagen, Denmark (Dr Andersen).""}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Vigna', 'Affiliation': ''}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Nava', 'Affiliation': ''}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'De Gennaro Colonna', 'Affiliation': ''}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ''}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Riboldi', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001844'] 1736,32434104,Effect of the mobile phone-related background on inhibitory control of problematic mobile phone use: An event-related potentials study.,"The present study aims to provide electrophysiological evidence for deficient inhibitory control in problematic mobile phone use and to investigate whether reduced inhibition is more pronounced during exposure to a mobile phone related background cue. A screen scale of smartphone addiction was completed by 227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study. Event-related potentials were recorded during a backgrounded Go/NoGo task performed by those two groups, in which either a frequent Go signal (letter ""M"") or a rare NoGo signal (letter ""W"") was superimposed on three different background cues: neutral, mobile phone application-related and mobile phone using-related pictures. Results showed that problematic mobile phone users performed more commission errors than controls following mobile phone application background. Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background. The result might suggest that there is no general impairment of inhibitory control in problematic mobile phone use. The deficient inhibitory control on behavioral and psychophysiological level appeared merely in the mobile phone-related background. Such deficient stimuli-specific inhibitory control appears at the late stage of inhibitory control. Prevention programs should be designed to curtail exposure to the mobile phone-related stimulus and enhance cognitive control of potential problematic mobile phone users.",2020,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","['227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study']",['mobile phone-related background'],"['behavioral and psychophysiological level', 'commission errors', 'NoGo P3 amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0394788,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","[{'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Jingfu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Qingbai', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Zongkui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China. Electronic address: zhouzk@mail.ccnu.edu.cn.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106363'] 1737,31478763,A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible Acute Coronary Syndrome in the Emergency Department With High-Sensitivity Troponin T Study (RAPID-TnT).,"BACKGROUND High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P <0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P <0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P <0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.",2019,The 0/1-hour hs-TnT protocol was not inferior to standard care,"['Patients', 'Median age was 59 (49-70) years, and 47% were female', 'Suspected Acute Coronary Syndromes', 'patients with newly recognized troponin T elevation', 'suspected ACS patients presenting to the emergency department (ED', '3378 participants with an emergency presentation were randomized between August 2015 and April 2019', 'Ninety participants were deemed ineligible or withdrew consent', 'suspected ACS patients']","['0/1-hour high-sensitivity troponin T (hs-cTnT) protocol compared with a 0/3-hour masked hs-cTnT protocol', '0/1-hour hs-cTnT', '1-Hour Troponin T Protocol', 'care guided either by the 0 /1-hour hs-cTnT protocol (n=1646) or the 3-hour standard masked hs-cTnT protocol', 'Possible ACS']","['median ED length of stay', 'cause death and MI. Non-inferiority', 'myocardial injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",90.0,0.236706,The 0/1-hour hs-TnT protocol was not inferior to standard care,"[{'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Chew', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lambrakis', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blyth', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Seshadri', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Edmonds', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth (T.B.).'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Cullen', 'Affiliation': ""Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Australia (L.A.C.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia (S.Q.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Karnon', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chuang', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Nelson', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide (D.P.C., A.J.C.).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Horsfall', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'College of Medicine & Public Health, Flinders University of South Australia, Adelaide (D.P.C., A.B., A.S., J.K., A.C., E.M.).'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'French', 'Affiliation': 'Department of Cardiology, University of New South Wales, Sydney, Australia (J.K.F.).'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Papendick', 'Affiliation': 'South Australian Department of Health, Adelaide (D.P.C., K.L., A.B., A.S., M.J.R.E., A.C., D.W., M.H., C.P.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042891'] 1738,31474116,Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus.,"BACKGROUND Patients with type 2 diabetes mellitus (T2DM) are at increased risk of developing heart failure. Sodium-glucose cotransporter-2 inhibitors reduce the risk of hospitalization for heart failure (HHF) in patients with T2DM. We aimed to develop and validate a practical clinical risk score for HHF in patients with T2DM and assess whether this score can identify high-risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor. METHODS We developed a clinical risk score for HHF in 8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using multivariable Cox regression, and independent clinical risk indicators achieving statistical significance of P <0.001 were included in the risk score. We externally validated the score in 8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58). The relative and absolute risk reductions in HHF with the sodium-glucose cotransporter-2 inhibitor dapagliflozin were assessed by baseline HHF risk. RESULTS Five clinical variables were independent risk predictors of HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio. A simple integer-based score (0-7 points) using these predictors identified a >20-fold gradient of HHF risk ( P for trend <0.001) in both the derivation and validation cohorts, with C indices of 0.81 and 0.78, respectively. Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. CONCLUSIONS Risk stratification using a novel clinical risk score for HHF in patients with T2DM identifies patients at higher risk for HHF who derive greater absolute benefit from sodium-glucose cotransporter-2 inhibition. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01107886 and NCT01730534.",2019,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. ","['Patients', 'patients with T2DM', '8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58', 'risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor', 'Patients With Type 2 Diabetes Mellitus', 'Patients with type 2 diabetes mellitus (T2DM', '8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53']","['dapagliflozin', 'Sodium-Glucose Cotransporter-2 Inhibitors', 'Saxagliptin', 'Sodium-glucose cotransporter-2 inhibitors']","['HHF: prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio', 'risk of hospitalization for heart failure (HHF', 'absolute risk reductions', 'HHF risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C3811844'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.0836097,"Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively. ","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Canada (L.A.L.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (D.K.M.).'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'University of Liverpool, United Kingdom (J.P.H.W.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042685'] 1739,31446213,Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial.,"BACKGROUND The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). METHODS Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. RESULTS Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of 'improvement' in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). CONCLUSION HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.",2019,"Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035).","['Patients', 'patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer', 'patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving']","['olaparib versus chemotherapy', 'olaparib', 'single-agent TPC', 'TPC', 'olaparib monotherapy', 'chemotherapy TPC']","[""overall response of 'improvement' in global health status/QoL"", 'Median time to global health status/QoL deterioration', 'Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires', 'Overall questionnaire compliance rates', 'Symptoms and functioning domains, best overall response and time to deterioration of QoL', 'For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score', 'HRQoL', 'global health status/QoL score', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.169143,"Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus -3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: robsonm@mskcc.org.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Senkus', 'Affiliation': 'Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Basser Center, University of Pennsylvania, Philadelphia, PA, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Beth Israel Deaconess Medical Center, Dana-Farber Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bannister', 'Affiliation': 'AstraZeneca, Milton, Cambridge, UK.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Degboe', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hettle', 'Affiliation': 'AstraZeneca, Milton, Cambridge, UK.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'University of Padova, Padova, Italy; Istituto Oncologico Veneto IRCCS, Padova, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.023'] 1740,31476897,Comparison of a Complete Percutaneous versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results from the Randomized SURTAVI Trial.,"BACKGROUND For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach. METHODS The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years. RESULTS Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). CONCLUSIONS For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov Unique Identifier: NCT01586910.",2019,"No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). ","['risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016', '169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients', '1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization', 'patients with severe aortic stenosis (AS) and coronary artery disease (CAD', 'Patients at Intermediate Surgical Risk', 'For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22']","['Complete Percutaneous versus Surgical Approach to Aortic Valve Replacement and Revascularization', 'transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR', 'TAVR', 'SAVR group had coronary artery bypass grafting (CABG', 'percutaneous coronary intervention (PCI']","['TAVR and PCI and SAVR and CABG', 'STS risk score for mortality', 'rate of all-cause mortality or disabling stroke', 'TAVR and SAVR']","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",1660.0,0.0673896,"No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76). ","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Søndergaard', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiovascular Surgery, Methodist DeBakey Heart and Vascular Center, Houston, TX.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Department of Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'George', 'Affiliation': 'Department of Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'Departments of Medicine (Cardiology) and Cardiothoracic Surgery, NYU-Langone Medical Center, New York, NY.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'Department of Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, OH.'}, {'ForeName': 'Arie P', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Departments of Cardiology and Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands; Structural Heart, Medtronic plc, Minneapolis, MN.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Grube', 'Affiliation': 'Department of Medicine II, Heart Center Bonn, Bonn, Germany.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Schiltgen', 'Affiliation': 'Structural Heart, Medtronic plc, Minneapolis, MN.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Structural Heart, Medtronic plc, Minneapolis, MN.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.118.039564'] 1741,31307883,"Intermittent preventive treatment with dihydroartemisinin-piperaquine and risk of malaria following cessation in young Ugandan children: a double-blind, randomised, controlled trial.","BACKGROUND Intermittent preventive treatment (IPT) of malaria with dihydroartemisinin-piperaquine is a promising strategy for malaria prevention in young African children. However, the optimal dosing strategy is unclear and conflicting evidence exists regarding the risk of malaria after cessation of chemoprevention. We aimed to compare two dosing strategies of IPT with dihydroartemisinin-piperaquine in young Ugandan children, and to evaluate the risk of malaria after cessation of IPT. METHODS In this double-blind, randomised controlled phase 2 trial, women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda). Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks). Women and their unborn children were randomly assigned (1:1:1:1) to one of four treatment groups, all receiving dihydroartemisinin-piperaquine, on the basis of the IPT intervention received by the woman during pregnancy: women every 8 weeks, children every 4 weeks; women every 4 weeks, children every 4 weeks; women every 8 weeks, children every 12 weeks; and women every 4 weeks, children every 12 weeks. Block randomisation was done by an independent investigator using a computer-generated randomisation list (permuted block sizes of six and 12). We analysed children on the basis of their random assignment to receive dihydroartemisinin-piperaquine (20 mg/160 mg tablets) once daily for 3 consecutive days every 4 weeks or 12 weeks. Children received study drugs from age 8 weeks to 24 months and were followed-up to age 36 months. Participants and investigators were masked to treatment allocation. The primary outcome was the incidence of symptomatic malaria during the intervention and following cessation of the intervention, adjusted for potential confounders. The primary outcome and safety were assessed in the modified intention-to-treat population, which included all children who reached 8 weeks of age and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02163447. FINDINGS Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group). During the intervention, the incidence of symptomatic malaria was significantly lower among children treated every 4 weeks than children treated every 12 weeks; three episodes occurred among children treated every 4 weeks (incidence 0·018 episodes per person-year) compared with 61 episodes among children treated every 12 weeks (incidence 0·39 episodes per person-year; adjusted incidence rate ratio [aIRR] 0·041, 95% CI 0·012-0·150, p<0·0001). After cessation of IPT, children who had previously received dihydroartemisinin-piperaquine every 4 weeks had a lower incidence of symptomatic malaria than children who were treated every 12 weeks; 62 episodes occurred among children previously treated every 4 weeks (incidence 0·73 episodes per person-year) compared with 83 episodes among children treated every 12 weeks (incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028). In the 4-week group, 94 (98%) of 96 children had adverse events versus 87 (100%) of 87 children in the 12-week group. The most commonly reported adverse event was cough in both treatment groups (94 [98%] in the 4-week group vs 87 [100%] in the 12-week group). 16 children had severe adverse events (seven [7%] children in the 4-week group vs nine [10%] children in the 12-week group). No severe adverse events were thought to be related to study drug administration. One death occurred during the intervention (age 8 weeks to 24 months), which was due to respiratory failure unrelated to malaria. INTERPRETATION IPT with dihydroartemisinin-piperaquine given every 4 weeks was superior to treatment every 12 weeks for the prevention of malaria during childhood, and this protection was extended for up to 1 year after cessation of IPT. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development.",2019,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","['young African children', 'young Ugandan children', 'Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks', 'Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group', 'women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda', 'Women and their unborn children']","['IPT intervention', 'dihydroartemisinin-piperaquine', 'IPT with dihydroartemisinin-piperaquine', 'dihydroartemisinin-piperaquine and risk of malaria following cessation']","['incidence of symptomatic malaria', 'severe adverse events', 'One death', 'adverse events', 'symptomatic malaria', 'incidence rate ratio [aIRR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0443061', 'cui_str': 'Tororo (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",191.0,0.351502,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. Electronic address: marymkakuru@gmail.com.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Bishop', 'Initials': 'B', 'LastName': 'Opira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaffer', 'Initials': 'J', 'LastName': 'Okiring', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nalugo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Charlebois', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Feeney', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda; School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30299-3'] 1742,30449156,Low income as a determinant of exercise capacity in COPD.,"Exercise capacity (EC) is a critical outcome in chronic obstructive lung disease (chronic obstructive pulmonary disease (COPD)). It measures the impact of the disease and the effect of specific interventions like pulmonary rehabilitation (PR). EC determines COPD prognosis and is associated with health-care utilization and quality of life. Field walking tests and cardiopulmonary exercise test (CPET) are two ways to measure EC. The 6-minute walking test (6MWT) is the commonest and easiest field test. CPET has the advantage of assessing maximal aerobic capacity. Determinants of EC include age, gender, breathlessness, and lung function. Previous research suggests that socioeconomic status (SES), a meaningful factor in COPD, may also be associated with EC. However, those findings have not been replicated. We aimed to determine whether SES is an independent factor associated with EC in COPD. For this analysis, we used the National Emphysema Treatment Trial (NETT) database. NETT was a multicenter clinical trial where severe COPD patients were randomized to lung volume reduction surgery or medical therapy. Measures used were taken at baseline, postrehabilitation. Patients self-reported their income and were divided in two groups whether it was less or above US$30,000. Patients with a lower income had worse results in 6MWT ( p < 0.0001). We found an independent association between income and the 6MWT in patients with severe COPD after adjusting for age, gender, lung function, dyspnea, and living conditions ( p < 0.0007). One previous publication stated the relationship between income and EC. Our research confirms and extends previous publications associating EC with income by studying a large and well characterized cohort of severe COPD patients, also addressing EC by two different methods (maximal watts and 6MWT). Our results highlight the importance of addressing social determinants of health such as income when assessing COPD patients.",2019,"We found an independent association between income and the 6MWT in patients with severe COPD after adjusting for age, gender, lung function, dyspnea, and living conditions ( p < 0.0007).","['chronic obstructive lung disease (chronic obstructive pulmonary disease (COPD', 'severe COPD patients']","['Exercise capacity (EC', 'lung volume reduction surgery or medical therapy', 'Field walking tests and cardiopulmonary exercise test (CPET', 'CPET', 'SES', 'specific interventions like pulmonary rehabilitation (PR']","['6-minute walking test (6MWT', '6MWT']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0375931', 'cui_str': 'Lung volume reduction surgery'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0295325,"We found an independent association between income and the 6MWT in patients with severe COPD after adjusting for age, gender, lung function, dyspnea, and living conditions ( p < 0.0007).","[{'ForeName': 'Ana Sofia', 'Initials': 'AS', 'LastName': 'Porta', 'Affiliation': '1 Mindful Breathing Laboratory, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Nyanjok', 'Initials': 'N', 'LastName': 'Lam', 'Affiliation': '1 Mindful Breathing Laboratory, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novotny', 'Affiliation': '2 Health Sciences Research-Biomedical Statistics and Informatics, Mayo Clinic, MN, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Benzo', 'Affiliation': '1 Mindful Breathing Laboratory, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chronic respiratory disease,['10.1177/1479972318809491'] 1743,12518293,Ketamine and fMRI BOLD signal: distinguishing between effects mediated by change in blood flow versus change in cognitive state.,"No human fMRI studies have examined ketamine effects on the BOLD signal change associated with cognitive task performance. We wished to distinguish between effects on 1) cerebral blood flow, with resultant change in BOLD signal; and 2) cognition and neural mechanisms underlying BOLD signal change associated with task performance. Eight right-handed men (mean age 28.75 years) received ketamine or saline i.v. in a randomized, double-blind manner (bolus 0.23 mg/kg; 0.5 mg/kg over 45 min to a maximum 1 hr). Subjects viewed 10 alternating 30-sec blocks of faces with neutral expressions and a fixation cross and discriminated gender of faces. Gradient echo echoplanar images were acquired on a GE Signa 1.5 T Neurovascular system. One hundred T2-weighted images depicting BOLD contrast were acquired over 5 min (for each task) at each of 14 near-axial noncontiguous 7-mm thick planes. Ketamine significantly increased dissociative phenomena and negative symptoms, but did not affect performance of the gender discrimination task. Significant BOLD signal change was demonstrated predominantly in occipitotemporal cortex with both ketamine and placebo. Only two clusters in middle occipital gyrus (BA 18) and precentral gyrus (BA 4) showed significantly decreased BOLD signal change during ketamine compared to placebo. BOLD signal change was not significantly greater in any region during ketamine. Our findings demonstrate subtle rather than major differences between the effects of ketamine and placebo upon the BOLD signal change during perception of face-non face contrast. We suggest that they represent task-dependent effects of the drug/placebo, rather than task-independent effects of the drug per se, and indicate that the effects of ketamine on cerebral blood flow are predominantly focal and task-dependent, rather than global and task-independent.",2003,Only two clusters in middle occipital gyrus (BA 18) and precentral gyrus (BA 4) showed significantly decreased BOLD signal change during ketamine compared to placebo.,['Eight right-handed men (mean age 28.75 years'],"['ketamine or saline i.v', 'ketamine', 'Ketamine', 'placebo']","['BOLD signal change', 'dissociative phenomena and negative symptoms', 'Significant BOLD signal change', 'BOLD signal change associated with cognitive task performance', 'blood flow', 'cerebral blood flow']","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",100.0,0.134418,Only two clusters in middle occipital gyrus (BA 18) and precentral gyrus (BA 4) showed significantly decreased BOLD signal change during ketamine compared to placebo.,"[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Abel', 'Affiliation': 'Institute of Psychiatry, London, United Kingdom. kathryn.m.abel@man.ac.uk'}, {'ForeName': 'Matthew P G', 'Initials': 'MP', 'LastName': 'Allin', 'Affiliation': ''}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kucharska-Pietura', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Andrew', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': ''}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': ''}]",Human brain mapping,[] 1744,31315577,Can targeted cover letters improve participation in health surveys? Results from a randomized controlled trial.,"BACKGROUND Improving response rates in epidemiologic studies is important for the generalizability of the outcome. The aim of this study was to examine whether it can be advantageous for participation to target different versions of the cover letters to different sample subgroups. METHODS A randomized trial was incorporated in a cross-sectional health survey in Denmark (n = 25,000) where a motivational sentence in the cover letter intended to heighten perceptions of relevance of the survey was varied among 11 sample subgroups (treatment groups). Ten different versions of a sentence outlining questionnaire themes were tested: each mentioned three out of five themes: stress, alcohol, sex, sleep problems, and contact with family and friends. An eleventh group, the control group, omitted this sentence. RESULTS On average, the additional motivational sentence resulted in a significantly lower response rate overall compared to the control group. However, the additional motivational sentence was found to have heterogeneous effects on survey response. Furthermore, the nature of the heterogeneity differed between the versions of the sentence. Specifically, the additional sentence tended to produce a higher response rate among the youngest age group and a lower response rate in the oldest age group compared to the generic letter. The use of alcohol in the motivational sentence tended to have a positive effect on response in the age group 16-24 years, and stress tended to have a positive effect in the age group ≥65 years. On the contrary, sex tended to have a negative effect in the age groups 45-64 years and ≥ 65 years. However, a significant interaction was only found between the use of stress and age group (p = < 0.0001). CONCLUSION The findings of significant and heterogeneous effects suggest that there is potential for a targeted approach to improve both response rates and sample composition. The uneven effect of the separate themes across age groups suggests that the selection of themes to be included in the motivational sentence is important for the use of targeted appeals to be successful and warrants further research to better identify which themes works in which contexts, in which subgroups and under which circumstances. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT03046368 , retrospectively registered February 8th, 2017.",2019,"The use of alcohol in the motivational sentence tended to have a positive effect on response in the age group 16-24 years, and stress tended to have a positive effect in the age group ≥65 years.","['cross-sectional health survey in Denmark (n\xa0=\u200925,000']",['motivational sentence'],"['response rate', 'response rate overall']","[{'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0357732,"The use of alcohol in the motivational sentence tended to have a positive effect on response in the age group 16-24 years, and stress tended to have a positive effect in the age group ≥65 years.","[{'ForeName': 'Anne Illemann', 'Initials': 'AI', 'LastName': 'Christensen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, 1455, Copenhagen K, Denmark. ach@si-folkesundhed.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lynn', 'Affiliation': 'Institute for Social and Economic Research, University of Essex, Colchester, CO4 3SQ, UK.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, 1455, Copenhagen K, Denmark.'}]",BMC medical research methodology,['10.1186/s12874-019-0799-4'] 1745,30826311,Efficacy of topical clotrimazole vs. topical tolnaftate in the treatment of otomycosis. A randomized controlled clinical trial.,"INTRODUCTION Otomycosis, an infection of the ear canal by fungi, is prevalent in hot and humid weather. Nevertheless, there is not sufficient evidence for the effectiveness of different topical antifungal treatments. Tolnaftate, is a topical antifungal agent described to be effective in the treatment of otomycosis. Currently there are not sufficient studies that prove its efficacy. OBJECTIVES To compare the efficacy of clotrimazole and tolnaftate administration in the treatment of otomycosis. MATERIAL AND METHODS A controlled, randomized and open clinical trial included patients diagnosed with fungal external otitis who were treated with topical antifungals, randomized into two treatment groups: (1) clotrimazole cream; (2) tolnaftate solution. They were microscopically evaluated at one and two weeks of treatment to determine resolution of disease. Recurrence and complications were recorded. Demographic and clinical variables were collected and analyzed. Follow-up and final outcomes (absence of infection) were compared between groups. RESULTS Forty eight patients were included, 28 in the clotrimazole group and 20 in the tolnaftate group. Spring was the weather most commonly associated with otomycosis, while otic manipulation was the risk factor more common in both groups. Predominant symptoms were itching and otic fullness. Aspergillus niger organism was isolated most frequently. Treatment with clotrimazole resulted in 75% resolution vs 45% resolution with treatment with tolnaftate at one week of treatment (p=0.007). The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. CONCLUSIONS Clotrimazole cream treatment is more effective than tolnaftate for uncomplicated otomycosis. More studies are needed to corroborate our results.",2020,"The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. ","['Forty eight patients were included, 28 in the Clotrimazole group and 20 in the Tolnaftate group', 'patients diagnosed with fungal external otitis who were treated with']","['topical clotrimazole vs. topical tolnaftate', 'clotrimazole', 'topical antifungals', 'Clotrimazole cream']","['itching and otic fullness', 'recurrence rates and treatment failures', 'Recurrence and complications']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040379', 'cui_str': 'Tolnaftate'}, {'cui': 'C0029878', 'cui_str': 'External Otitis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0040379', 'cui_str': 'Tolnaftate'}, {'cui': 'C4552580', 'cui_str': 'Antifungal (disposition)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C4521969', 'cui_str': 'Otic'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0162643'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",48.0,0.127742,"The Tolnaftate treatment group demonstrated higher recurrence rates and treatment failures, 20% and 15% respectively. ","[{'ForeName': 'Lesly', 'Initials': 'L', 'LastName': 'Jimenez-Garcia', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Celis-Aguilar', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico. Electronic address: erikacelis@hotmail.com.'}, {'ForeName': 'Gaudencio', 'Initials': 'G', 'LastName': 'Díaz-Pavón', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Muñoz Estrada', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Mycology Department, Culiacán, Mexico.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Castro-Urquizo', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Nemiliztli', 'Initials': 'N', 'LastName': 'Hernández-Castillo', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Amaro-Flores', 'Affiliation': 'Universidad Autónoma de Sinaloa, Centro de Investigación y Docencia en Ciencias de la Salud, Otolaryngology Department, Culiacán, Mexico.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2018.12.007'] 1746,31288906,Lung Bioposy Without Pleural Drainage.,"BACKGROUND Video-assisted thoracoscopy and atypical resection of lung parenchyma is a surgical procedure that is carried out very commonly around the world, mainly to determine the degree of malignancy of a suspect pulmonary nodule. A pleural drain is routinely inserted at the end of the procedure. The goal of our study was to evaluate the outcomes of this procedure with and without pleural drainage. METHODS From June 2015 to January 2018, 74 patients were prospectively randomized to either the chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT group, 37 patients) and were followed up until the seventh day after surgery. The postoperative duration of hospital stay was the primary endpoint; the secondary endpoints were the rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption. Blinding was not possible. An intention- to-treat analysis was performed. (Study registration; DRKS00008194, www.drks.de/drks.). RESULTS Hospital stays were significantly shorter in the NCT group (means and first and fourth quartiles: 1.5 [1.5; 1.5] versus 2.5 [2.5, 2.5] days, p<0.001). The two groups did not differ significantly with respect to the frequency of postoperative complications. There were two occurrences of postoperative pneumothorax in the NCT group, with one patient needing drainage via chest tube and the other needing no treatment. Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). CONCLUSION Not inserting a chest tube after video-assisted thoracoscopic lung biopsy significantly shortens the postoperative hospital stay, and the complications in the chest-tube and no-chest-tube groups are similar. Postoperative pain and analgesic consumption are markedly less when no chest tube is inserted.",2019,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). ","['From June 2015 to January 2018, 74 patients']","['NCT', 'chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT']","['postoperative hospital stay', 'postoperative pneumothorax', 'Pain intensity and analgesic consumption', 'Postoperative pain and analgesic consumption', 'rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption', 'Hospital stays', 'cumulative oral intake of metamizole and acetaminophen', 'postoperative duration of hospital stay', 'frequency of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012586', 'cui_str': 'Metamizole'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",74.0,0.0546485,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lesser', 'Affiliation': 'Department of Thoracic-and Vascular Surgery, Lung Cancer Center DKG, SRH Wald-Klinikum Gera, Germany; Department of Cardiothoracic Surgery, University Hospital Jena, Germany; Institute for Medical Statistics, Computer Science, and Data Science, University Hospital Jena, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': ''}, {'ForeName': 'Jerar', 'Initials': 'J', 'LastName': 'Mukdessi', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0329'] 1747,31722694,STructured lifestyle education for people WIth SchizophrEnia (STEPWISE): mixed methods process evaluation of a group-based lifestyle education programme to support weight loss in people with schizophrenia.,"BACKGROUND STEPWISE is a theory-informed self-management education programme that was co-produced with service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia. We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised controlled trial (RCT) that evaluated its efficacy. METHODS Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity, using the programme theory and a pipeline logic model. We followed a modified version of Linnan and Steckler's framework and single case design. Qualitative data from semi-structured telephone interviews with service-users (n = 24), healthcare professionals delivering the intervention (n = 20) and interventionists (n = 7) were triangulated with quantitative process and RCT outcome data and with observations by interventionists, to examine convergence within logic model components. RESULTS Training and course materials were available although lacked co-ordination in some trusts. Healthcare professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) 'style' of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare professionals recognised the need to address antipsychotic-induced weight gain and reported potential value from the intervention (subject to the RCT results). However, some doubted senior management commitment and sustainability post-trial. Service-users found the intervention highly acceptable, especially being in a group of people with similar experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with 23% (n = 47) attending all group-sessions and 17% (n = 36) attending none. Service-users who lost weight wanted closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention. CONCLUSIONS This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of contact and objective monitoring can support people with schizophrenia to lose weight. TRIAL REGISTRATION ISRCTN, ISRCTN19447796. Registered 20 March 2014.",2019,"No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention. ","['people with schizophrenia', 'people WIth SchizophrEnia (STEPWISE']","['mixed methods process evaluation of a group-based lifestyle education programme', 'healthcare professionals delivering the intervention']","['RCT outcomes', 'weight loss']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0741741,"No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention. ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gossage-Worrall', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. r.gossage-worrall@sheffield.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hind', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Katharine D', 'Initials': 'KD', 'LastName': 'Barnard-Kelly', 'Affiliation': 'Faculty of Health & Social Science, Bournemouth University, Poole, Dorset, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Honorary Research Consultant, Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust and Honorary Reader in Early Psychosis, School of Health Sciences, Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Etherington', 'Affiliation': 'Patient Representative, Independent Service User Consultant, Manchester, UK.'}, {'ForeName': 'Lizzie', 'Initials': 'L', 'LastName': 'Swaby', 'Affiliation': 'Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.'}, {'ForeName': 'Richard I G', 'Initials': 'RIG', 'LastName': 'Holt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-019-2282-5'] 1748,31299663,"Interferon Alpha-2b Eye Drops Prevent Recurrence of Pterygium After the Bare Sclera Technique: A Single-Center, Sequential, and Controlled Study.","PURPOSE To investigate the efficacy and safety of interferon (IFN) alpha-2b eye drops in preventing pterygium recurrence after the bare sclera technique. METHODS Sixty eyes in 53 patients who underwent treatment for primary pterygium (the length of corneal invasion ranged from 2 to 4 mm) were enrolled in this prospective study. All patients were divided in chronological sequence into 2 groups. The control group included the first 30 eyes, whereas the treatment group included the next 30 eyes. After treatment with the bare sclera technique, levofloxacin and 0.1% fluorometholone eye drops were used 4 times a day for 3 months after surgical excision in both groups. In addition, IFN alpha-2b eye drops were applied in the treatment group 4 times a day for 3 months. Throughout an 18-month follow-up period, all patients in both groups were examined 1 day, 10 days, 1 month, 3 months, 6 months, 12 months, and 18 months after surgery. The main outcome measures were pterygium recurrence, conjunctival redness and thickness, and neovascularization and complications (ie, delayed conjunctival healing, persistent corneal epithelial defection, conjunctival granuloma, and scleral melting and necrosis). RESULTS The recurrence rates in the control group and the treatment group at the end of the sixth month were 29.2% and 3.7%, respectively, and the rates were significantly different between the 2 groups (P = 0.019). Up to 12 months after surgeries, the recurrence rate was 33.3% in the control group and 7.4% in the treatment group, and the difference between the 2 groups was statistically significant (P = 0.048). The rates at the end of 18 months were the same. During the follow-up period, no complications were observed except for 1 conjunctival granuloma (in the treatment group) and 2 corneal epithelial defects (one in the control group and the other in the treatment group). CONCLUSIONS Administration of IFN alpha-2b eye drops after the bare sclera technique appear safe and effective in reducing the recurrence of pterygium.",2019,"During the follow-up period, no complications were observed except for 1 conjunctival granuloma (in the treatment group) and 2 corneal epithelial defects (one in the control group and the other in the treatment group). ",['Sixty eyes in 53 patients who underwent treatment for primary pterygium (the length of corneal invasion ranged from 2 to 4 mm'],"['Interferon Alpha-2b Eye Drops', 'levofloxacin and 0.1% fluorometholone', 'interferon (IFN) alpha-2b eye drops']","['recurrence rate', 'corneal epithelial defects', 'Recurrence of Pterygium', 'recurrence of pterygium', 'pterygium recurrence', 'efficacy and safety', 'recurrence rates', 'pterygium recurrence, conjunctival redness and thickness, and neovascularization and complications (ie, delayed conjunctival healing, persistent corneal epithelial defection, conjunctival granuloma, and scleral melting and necrosis']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1299691', 'cui_str': 'Corneal epithelial defect'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0155165', 'cui_str': 'Granuloma of conjunctiva (disorder)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]",60.0,0.0244051,"During the follow-up period, no complications were observed except for 1 conjunctival granuloma (in the treatment group) and 2 corneal epithelial defects (one in the control group and the other in the treatment group). ","[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Science Key Lab, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yingnan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': ''}]",Cornea,['10.1097/ICO.0000000000001995'] 1749,31470735,The Use of Online Physician Training Can Improve Patient Experience and Physician Burnout.,"The authors tested the efficacy of an integrated approach to improving patient experience and physician burnout using a 24-week online training program coupled with a physician engagement strategy. Physicians from different disciplines were randomized to intervention (n = 30) and control (n = 33) groups. Patient experience, physician burnout, and satisfaction data were assessed using patient and provider surveys. Comparisons were made pre and post intervention, and between the groups. Intervention group mean scores increased (+1.40 points) while control group scores dropped (-0.11 points; P = .039). Scores on physician burnout surveys for the intervention group improved in all areas and changes in 2 domains were statistically significant. In all, 73.5% of physicians felt the program was effective. This integrated intervention enhanced patient experience scores and positively affected physicians' level of burnout, and physicians believed this exercise was useful.",2020,Intervention group mean scores increased (+1.40 points) while control group scores dropped (-0.11 points; P = .039).,[],['Online Physician Training'],"['Patient experience, physician burnout, and satisfaction data']",[],"[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0129183,Intervention group mean scores increased (+1.40 points) while control group scores dropped (-0.11 points; P = .039).,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Congiusta', 'Affiliation': 'Northwell Health, New Hyde Park, NY.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Ascher', 'Affiliation': 'Northwell Health, New Hyde Park, NY.'}, {'ForeName': 'Seungjun', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'Feinstein Institute for Medical Research, Northwell Health, Great Neck, NY.'}, {'ForeName': 'Ira S', 'Initials': 'IS', 'LastName': 'Nash', 'Affiliation': 'Northwell Health, New Hyde Park, NY.'}]",American journal of medical quality : the official journal of the American College of Medical Quality,['10.1177/1062860619869833'] 1750,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041'] 1751,31848172,"Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial).","INTRODUCTION Anastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children. METHODS AND ANALYSIS This is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist-blinded for randomisation-will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with <28 days' interval, which will be analysed with a linear-by-linear χ 2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6 months, with evaluation at 2-3 weeks, 3 and 6 months after the intervention. ETHICS AND DISSEMINATION Patients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018-1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences. TRIAL REGISTRATION NUMBERS 2018-002863-24 and NTR7726/NL7484.",2019,"We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children. ","['Children with OA type C (n=110', 'patients with oesophageal atresia']","['Intralesional steroid injections', 'intralesional steroid injection followed by balloon dilatation or dilatation only']","[""total number of dilatations needed with <28 days' interval, which will be analysed with a linear-by-linear χ 2 association test"", 'refractory strictures', 'level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014850', 'cui_str': 'Esophageal Atresia'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1318509', 'cui_str': 'Contrast radiography of esophagus (procedure)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.280462,"We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children. ","[{'ForeName': 'Chantal A', 'Initials': 'CA', 'LastName': 'Ten Kate', 'Affiliation': ""Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vlot', 'Affiliation': ""Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands john.vlot@erasmusmc.nl.""}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'IJsselstijn', 'Affiliation': ""Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Allegaert', 'Affiliation': ""Department of Paediatrics, Division of Neonatology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Manon C W', 'Initials': 'MCW', 'LastName': 'Spaander', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': 'Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Department of Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Erica L T', 'Initials': 'ELT', 'LastName': 'van den Akker', 'Affiliation': ""Department of Paediatric Endocrinology, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",BMJ open,['10.1136/bmjopen-2019-033030'] 1752,2647992,The reduction of low density lipoprotein cholesterol by metformin is maintained with long-term therapy.,"Changes in serum lipoproteins were studied in 14 non-insulin dependent diabetics on long-term metformin therapy, after 6 weeks' placebo, and again 6 weeks after restarting active drug therapy. Withdrawal of metformin resulted in a rise of fasting blood glucose, HbA1, serum total and low density lipoprotein (LDL) cholesterol. Restarting the drug reversed these changes. Multivariate analysis showed that serum total and LDL cholesterol varied with treatment but not with glycaemic control. Metformin can lower serum total and LDL cholesterol in non-insulin dependent diabetics and this effect is maintained long term.",1989,"Withdrawal of metformin resulted in a rise of fasting blood glucose, HbA1, serum total and low density lipoprotein (LDL) cholesterol.",[],"['Metformin', 'placebo', 'metformin']","['fasting blood glucose, HbA1, serum total and low density lipoprotein (LDL) cholesterol', 'serum lipoproteins', 'low density lipoprotein cholesterol', 'serum total and LDL cholesterol']",[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]",14.0,0.0406745,"Withdrawal of metformin resulted in a rise of fasting blood glucose, HbA1, serum total and low density lipoprotein (LDL) cholesterol.","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Rains', 'Affiliation': ""Department of Endocrinology, St Mary's Hospital, London.""}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Richmond', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Elkeles', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1753,31469303,Lixisenatide versus insulin glulisine on top of insulin glargine in patients with type 2 diabetes mellitus: a cost-per-responder analysis in China.,"Objective: To compare the cost per responder of lixisenatide versus insulin glulisine once daily (basal-plus) and three times daily (basal-bolus) on top of basal insulin for the treatment of patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin in China. Methods: The cost per responder was estimated based on clinical data obtained from the GetGoal Duo-2 clinical trial and direct medical costs from the perspective of the Chinese healthcare system over a 52-week time horizon. The response was assessed at week 26 in the clinical trial, which was extrapolated to 52 weeks to estimate the annual cost per responder. Responders were primarily defined using a composite endpoint that based on an HbA1c ≤ 7.0% threshold AND no weight gain With or Without no documented symptomatic hypoglycemia. Composite endpoints with varied HbA1c thresholds were defined in secondary analyses. Results: For the composite endpoint of HbA1c threshold ≤7.0% AND no weight gain, the annual cost per responder results were 96,722 CNY, 122,552 CNY and 135,926 CNY (14,616, 18,520 and 20,541 US dollars) for lixisenatide combined with basal insulin, basal-plus, and basal-bolus, respectively. For the composite endpoint of HbA1c threshold ≤7.0% AND no weight gain AND no documented symptomatic hypoglycemia, the annual cost per responder results were 136,290 CNY, 231,487 CNY and 222,424 CNY (20,596, 34,982 and 33,612 US dollars) for lixisenatide combined with basal insulin, basal-plus, and basal-bolus, respectively. The secondary analyses proved similar results. Conclusion: Lixisenatide combined with basal insulin is associated with a lower cost per responder compared with basal-plus and basal-bolus for T2DM patients inadequately controlled by basal insulin in China.",2020,Lixisenatide combined with basal insulin is associated with a lower cost per responder compared with basal-plus and basal-bolus for T2DM patients inadequately controlled by basal insulin in China.,"['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin in China']","['Lixisenatide versus insulin glulisine', 'Lixisenatide combined with basal insulin', 'insulin glargine', 'lixisenatide versus insulin glulisine']","['symptomatic hypoglycemia', 'weight gain', 'weight gain AND no documented symptomatic hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C1313386', 'cui_str': 'insulin glulisine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",,0.078482,Lixisenatide combined with basal insulin is associated with a lower cost per responder compared with basal-plus and basal-bolus for T2DM patients inadequately controlled by basal insulin in China.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Men', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Chaoyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Health Economics and Outcome Research, Sanofi, Shanghai, China.'}, {'ForeName': 'Suodi', 'Initials': 'S', 'LastName': 'Zhai', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'Real World Insights, IQVIA, Shanghai, China.'}]",Current medical research and opinion,['10.1080/03007995.2019.1662676'] 1754,32439603,The effects of imaginary eating on visual food cue reactivity: An event-related potential study.,"Previous research has demonstrated that imagining consumption of a specific type of food helps individuals to consume less of that food. The present event-related potential study aimed at investigating the underlying neural correlates of this appetite-reducing strategy. A total of 86 women (mean age = 23.65 years) were randomly assigned to one of three imagination conditions. In each condition, they listened to a guided imagery script that either described the eating of 30 colorful button-shaped chocolates (M&Ms), the sorting of 30 M&Ms by color, or the sorting of 30 marbles by color. Subsequently to the imagery task, the participants were presented with images of M&Ms and marbles while their electroencephalogram and craving ratings were recorded. The results showed that imaginary eating did not reduce the appetitive value of M&M pictures. The M&M sorting group reported enhanced craving and showed increased late positivity toward M&M pictures (300-600 ms after picture onset) compared to the two other groups. The present findings indicate that the imagined handling of food increases food cue reactivity and that imaginary eating is not a reliable method to reduce appetite.",2020,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,['86 women (mean age\u202f=\u202f23.65 years'],['imaginary eating'],"['enhanced craving', 'appetitive value of M&M pictures', 'visual food cue reactivity', 'electroencephalogram and craving ratings', 'late positivity toward M&M pictures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",86.0,0.0227251,The results showed that imaginary eating did not reduce the appetitive value of M&M pictures.,"[{'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria; Department of Psychology, Faculty of Arts, University of Maribor, Slovenia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Clinical Psychology, University of Graz, BioTechMed, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Appetite,['10.1016/j.appet.2020.104743'] 1755,30680738,Economic evaluation of simulated and traditional clinical placements in occupational therapy education.,"INTRODUCTION This economic evaluation complements results of the randomised controlled trial that established non-inferiority of the learning outcomes of a one-week simulated clinical placement (SCP) in occupational therapy qualifying degrees in comparison to an equivalent traditional clinical placement (TCP). This companion study presents detailed cost analyses of two placement alternatives and a cost-benefit study to assess the value for money of SCP. An economic evaluation of simulated versus traditional placements has not previously been conducted in Australia. METHODS Nine SCP/TCP rounds were conducted by six Australian universities. Costs were collected using study-specific instruments. Public health sector costs were sourced from available literature. Willingness-to-pay for SCP/TCP was estimated using both a Discrete Choice Experiment and a Contingent Valuation method. These methods were employed to assess a comparative 'value' of SCP/TCP from the perspective of heads of occupational therapy departments (N = 28), who were asked to put a monetary value on the broader range of benefits associated with SCP/TCP. RESULTS From the universities' perspective the average cost per student ranged from AUD$460 to AUD$1511 for simulated and AUD$144 to AUD$1112 for traditional placement. From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five. In the Discrete Choice Experiment respondents preferred traditional rather than simulated placement and would pay additional AUD$533. The estimated monetary value of simulated placements from a contingent valuation ranged from AUD$200 to AUD$1600. CONCLUSIONS For universities that procure TCPs predominately at public health care facilities and sustain high administrative overheads, the SCP program could be a cost-saving alternative. From a broader value-for-money perspective, respondents favoured TCP over SCP, yet placed importance on placement availability and opportunity to demonstrate competence for students during the placement. Results should be interpreted with caution and further research with larger sample sizes is required.",2019,"From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five.","['occupational therapy education', 'Nine SCP/TCP rounds were conducted by six Australian universities']",[],[],"[{'cui': 'C1444297', 'cui_str': 'Occupational therapy education (procedure)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",[],[],,0.0294318,"From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gospodarevskaya', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Imms', 'Affiliation': 'School of Allied Health, Australian Catholic University, Fitzroy, VIC, Australia.'}, {'ForeName': 'Eli Mang Yee', 'Initials': 'EMY', 'LastName': 'Chu', 'Affiliation': 'Monash University, Fitzroy, VIC, Australia.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Nicola-Richmond', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, VIC, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gribble', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Faculty of Health Sciences, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Elspeth', 'Initials': 'E', 'LastName': 'Froude', 'Affiliation': 'School of Allied Health, Australian Catholic University, Fitzroy, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Guinea', 'Affiliation': 'Faculty of Health Sciences, Australian Catholic University, Fitzroy, VIC, Australia.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Sheppard', 'Affiliation': 'School of Allied Health, Australian Catholic University, Fitzroy, VIC, Australia.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Iezzi', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Faculty of Health Sciences, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Centre for Health Economics, Monash Business School, Monash University, Clayton, VIC, Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12563'] 1756,30819457,Does dose of early intervention matter for preschoolers with externalizing behavior problems? A pilot randomized trial comparing intensive summer programming to school consultation.,"The goals of this study were to (a) isolate the ideal length (i.e., 4 or 8 weeks) of the Summer Treatment Program for Kindergarteners (STP-PreK) for improving school readiness and kindergarten success outcomes of preschool children with externalizing behavior problems (EBPs) during the transition to kindergarten; and (b) compare the STP-PreK model to a more standard approach in school settings (i.e., behavioral school consultation). Forty-five preschool children (82% boys; Mage = 5.16 years; 93% Hispanic/Latino background) were randomized to one of three intervention conditions: 1) 8-week STP-PreK (8W); 2) 4-week STP-PreK (4W); or 3) school year behavioral consultation (SC). Both STP-PreK groups included an 8-week parent training component. Baseline, post-intervention, and 6-month follow-up data were collected on children's school readiness and kindergarten success outcomes including parent, teacher, and objective assessment measures. Analyses using linear mixed models indicated that children's behavioral, academic, social-emotional, and self-regulation functioning significantly improved across groups. Few significant differences were found between children receiving the 4W and 8W programs, suggesting that both programs have the potential to prepare preschool children with EBP for the transition to school. Both 4W and 8W groups experienced greater initial growth across time in most domains compared to children in the SC group. However, by the end of the kindergarten year, children in the SC group caught up to children in both 4W and 8W groups on most domains. Overall, these findings suggest that all three intervention doses are effective in improving kindergarten year functioning, with some important considerations for intervention timing in preparation for the transition to elementary school. Clinical implications for school personnel are discussed.",2019,Both 4W and 8W groups experienced greater initial growth across time in most domains compared to children in the SC group.,"['preschool children with externalizing behavior problems (EBPs', 'preschoolers with externalizing behavior problems', 'Forty-five preschool children (82% boys; Mage\u202f=\u202f5.16\u202fyears; 93% Hispanic/Latino background']","['STP-PreK (4W); or 3) school year behavioral consultation (SC', '8-week STP-PreK (8W', 'STP-PreK']","[""children's school readiness and kindergarten success outcomes including parent, teacher, and objective assessment measures"", ""children's behavioral, academic, social-emotional, and self-regulation functioning"", 'initial growth across time']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",45.0,0.0246441,Both 4W and 8W groups experienced greater initial growth across time in most domains compared to children in the SC group.,"[{'ForeName': 'Katie C', 'Initials': 'KC', 'LastName': 'Hart', 'Affiliation': 'Center for Children and Families, Department of Psychology, Florida International University, United States of America. Electronic address: khart@fiu.edu.'}, {'ForeName': 'Andre V', 'Initials': 'AV', 'LastName': 'Maharaj', 'Affiliation': 'Center for Children and Families, Department of Psychology, Florida International University, United States of America.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Center for Children and Families, Department of Psychology, Florida International University, United States of America.'}]",Journal of school psychology,['10.1016/j.jsp.2018.12.007'] 1757,11559960,Localization of MDMA-induced brain activity in healthy volunteers using low resolution brain electromagnetic tomography (LORETA).,"3,4-Methylenedioxymethamphetamine (MDMA; 'Ecstasy') is a psychostimulant drug producing heightened mood and facilitated social communication. In animal studies, MDMA effects are primarily mediated by serotonin (5-HT), but also by dopamine (DA) and possibly noradrenaline (NA). In humans, however, the neurochemical and neurophysiological basis of acute MDMA effects remains unknown. The distribution of active neuronal populations after administration of a single dose of MDMA (1.7 mg/kg) or placebo was studied in 16 healthy, MDMA-naïve volunteers. Thirty-one-channel scalp EEGs during resting with open and closed eyes was analyzed in the different EEG frequency bands. Scalp maps of power showed significant, global differences between MDMA and placebo in both eye conditions and all frequency bands. Low resolution brain electromagnetic tomography (LORETA) was used to compute 3D, functional images of electric neuronal activity from the scalp EEG data. MDMA produced a widespread decrease of slow and medium frequency activity and an increase of fast frequency activity in the anterior temporal and posterior orbital cortex, concomitant with a marked enhancement of mood, emotional arousal and increased extraversion. This activation of frontotemporal areas indicates that the observed enhancement of mood and possibly the increased extroversion rely on modulation of limbic orbitofrontal and anterotemporal structures known to be involved in emotional processes. Comparison of the MDMA-specific EEG pattern with that of various 5-HT, DA, and NA agonists indicates that serotonin, noradrenaline, and, to a lesser degree, dopamine, contribute to the effects of MDMA on EEG, and possibly also on mood and behavior.",2001,"MDMA produced a widespread decrease of slow and medium frequency activity and an increase of fast frequency activity in the anterior temporal and posterior orbital cortex, concomitant with a marked enhancement of mood, emotional arousal and increased extraversion.","['healthy volunteers using low resolution brain electromagnetic tomography (LORETA', '16 healthy, MDMA-naïve volunteers']","['MDMA-induced brain activity', 'MDMA', '3,4-Methylenedioxymethamphetamine', 'placebo', 'Low resolution brain electromagnetic tomography (LORETA', 'MDMA and placebo']","['fast frequency activity', 'slow and medium frequency activity', 'mood, emotional arousal and increased extraversion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015382', 'cui_str': 'Extroversion'}]",16.0,0.0243121,"MDMA produced a widespread decrease of slow and medium frequency activity and an increase of fast frequency activity in the anterior temporal and posterior orbital cortex, concomitant with a marked enhancement of mood, emotional arousal and increased extraversion.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Frei', 'Affiliation': 'University Hospital of Psychiatry, Zurich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gamma', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pascual-Marqui', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lehmann', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hell', 'Affiliation': ''}, {'ForeName': 'F X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': ''}]",Human brain mapping,[] 1758,30819458,Do organizational conditions influence teacher implementation of effective classroom management practices: Findings from a randomized trial.,"Although there is a growing evidence base about effective classroom management practices, teacher implementation of these practices varies due to a number of factors. A school's organizational health is one aspect of the broader social environment that has been hypothesized to influence implementation of interventions. Yet, empirical evidence is limited on whether organizational contexts can influence teacher implementation of effective interventions and subsequently, classroom environments and student outcomes. In the present study, teachers in an urban school district were randomly assigned to receive training in the Incredible Years Teacher Classroom Management program (IY TCM), a classroom management intervention. We examined how teacher perceptions of their school environment moderated intervention effects for previously established treatment outcomes - implementation of effective classroom methods, students' social behaviors, emotional regulation, and social competence. Results showed that treatment effects on teacher implementation and student outcomes were moderated by teachers' sense of affiliation to their school. Specifically, main effects on implementation of effective classroom management strategies were only observed among teachers whose perceptions of initial teacher affiliation was low or average; whereas main effects on student outcomes were only found for teachers with initial high levels of affiliation.",2019,Results showed that treatment effects on teacher implementation and student outcomes were moderated by teachers' sense of affiliation to their school.,['teachers in an urban school district'],"['training in the Incredible Years Teacher Classroom Management program (IY TCM), a classroom management intervention']","['social behaviors, emotional regulation, and social competence']","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}]",,0.0227596,Results showed that treatment effects on teacher implementation and student outcomes were moderated by teachers' sense of affiliation to their school.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sebastian', 'Affiliation': 'University of Missouri, Columbia, USA. Electronic address: sebastianji@missouri.edu.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Herman', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Reinke', 'Affiliation': 'University of Missouri, Columbia, USA.'}]",Journal of school psychology,['10.1016/j.jsp.2018.12.008'] 1759,31425966,Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial.,"BACKGROUND Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results. PATIENTS AND METHODS Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m 2 d1) and fluorouracil (800 mg/m 2 d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m 2 cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population). RESULTS After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029). CONCLUSION IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients.",2019,"The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029). ","['locoregionally advanced nasopharyngeal carcinoma (NPC) patients', 'locoregionally advanced nasopharyngeal carcinoma', '476 randomised patients (intention-to-treat population', 'patients with stage III-IVB (except T3N0-1) NPC']","['Induction chemotherapy', 'chemoradiotherapy versus concurrent chemoradiotherapy alone', 'induction chemotherapy (IC) with cisplatin and fluorouracil', '80\xa0mg/m 2 cisplatin', 'concurrent chemoradiotherapy (CCRT) versus CCRT', 'radiotherapy', 'cisplatin', 'CCRT', 'fluorouracil']","['5-year DMFS rate', '5-year OS rate', '5-year DFS rate', 'distant metastasis-free survival (DMFS', 'DFS and DMFS', 'disease-free survival (DFS', 'proportion of patients with eye damage', 'locoregional relapse-free survival\xa0and overall survival (OS']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.259479,"The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029). ","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Su-Mei', 'Initials': 'SM', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Hua', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiao-Long', 'Initials': 'XL', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'You', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'You-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yu-Long', 'Initials': 'YL', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhi-Qiang', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hai-Qiang', 'Initials': 'HQ', 'LastName': 'Mai', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lin-Quan', 'Initials': 'LQ', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hao-Yuan', 'Initials': 'HY', 'LastName': 'Mo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ka-Jia', 'Initials': 'KJ', 'LastName': 'Cao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chao-Nan', 'Initials': 'CN', 'LastName': 'Qian', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yan-Qun', 'Initials': 'YQ', 'LastName': 'Xiang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xiu-Ping', 'Initials': 'XP', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zhi-Xiong', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Wei-Xiong', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: guoxiang@sysucc.org.cn.'}, {'ForeName': 'Ming-Huang', 'Initials': 'MH', 'LastName': 'Hong', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: hongmh@sysucc.org.cn.'}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: chenmy@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.007'] 1760,31270055,[Efficacy of erector spinae block versus retrolaminar block for postoperative analgesia following posterior lumbar surgery].,"OBJECTIVE To compare the effect of erector spinae plane block and retrolaminar block for relieving acute pain after posterior lumbar surgery. METHODS Eighty-nine patients undergoing selective posterior lumbar surgery under general anesthesia in our hospital between January and December, 2018, were recruited. Of these patients, 30 received total intravenous general anesthesia to serve as the control group, 28 received total intravenous general anesthesia (TIVA) combined with erector spinae plane block (ESPB), and 31 had TIVA combined with retrolaminar block (RLB). All the patients received patient-controlled intravenous analgesia (PCIA) for postoperative analgesia, and their heart rate, blood pressure, and pulse oximetry were routinely monitored during the anesthesia. VAS scores were evaluated before and at 2, 8, 12, 24, and 48 h after the surgery. Sufentanil consumption during the operation and PCIA were also recorded. The postoperative complications such as nausea and vomiting, urinary retention, itching and respiratory depression within 48 h after the surgery were also recorded. RESULTS At 2, 8 and 12 h postoperatively, VAS scores in the ESPB group and RLB group were significantly lower than those in the control group; the scores were significantly lower in RLB group than in ESPB group ( P < 0.05). Compared with that in the control group, sufentanil consumption during the operation and PCIA were significantly decreased in both ESPB and RLB groups, particularly in the latter group ( P < 0.05). Two patients experienced nausea and vomiting and 1 patient complained of pruritus in control group; 1 patient had over sedation and 1 had urinary retention in ESPB group; 1 patient had urinary retention in RLB group. CONCLUSIONS Ultrasound-guided RLB has better analgesic effect than ESPB for management of perioperative pain following posterior lumbar surgery.",2019,"At 2, 8 and 12 h postoperatively, VAS scores in the ESPB group and RLB group were significantly lower than those in the control group; the scores were significantly lower in RLB group than in ESPB group ( P < 0.05).","['posterior lumbar surgery', 'Eighty-nine patients undergoing selective posterior lumbar surgery under general anesthesia in our hospital between January and December, 2018, were recruited']","['total intravenous general anesthesia (TIVA) combined with erector spinae plane block (ESPB), and 31 had TIVA combined with retrolaminar block (RLB', 'patient-controlled intravenous analgesia (PCIA', 'ESPB', 'erector spinae block versus retrolaminar block', 'erector spinae plane block and retrolaminar block']","['postoperative complications such as nausea and vomiting, urinary retention, itching and respiratory depression', 'heart rate, blood pressure, and pulse oximetry', 'analgesic effect', 'Sufentanil consumption', 'VAS scores', 'nausea and vomiting and 1 patient complained of pruritus', 'sufentanil consumption', 'urinary retention']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",89.0,0.0356343,"At 2, 8 and 12 h postoperatively, VAS scores in the ESPB group and RLB group were significantly lower than those in the control group; the scores were significantly lower in RLB group than in ESPB group ( P < 0.05).","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Tao', 'Affiliation': ""Department of Anesthesiology, Zhanjiang Central People's Hospital, Zhanjiang 524045, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Zhanjiang Central People's Hospital, Zhanjiang 524045, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2019.06.17'] 1761,31283407,Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study.,"PURPOSE Infant acute lymphoblastic leukemia (ALL) is characterized by KMT2A ( MLL ) gene rearrangements and coexpression of myeloid markers. The Interfant-06 study, comprising 18 national and international study groups, tested whether myeloid-style consolidation chemotherapy is superior to lymphoid style, the role of stem-cell transplantation (SCT), and which factors had independent prognostic value. MATERIALS AND METHODS Three risk groups were defined: low risk (LR): KMT2A germline; high risk (HR): KMT2A -rearranged and older than 6 months with WBC count 300 × 10 9 /L or more or a poor prednisone response; and medium risk (MR): all other KMT2A -rearranged cases. Patients in the MR and HR groups were randomly assigned to receive the lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE). RESULTS A total of 651 infants were included, with 6-year event-free survival (EFS) and overall survival of 46.1% (SE, 2.1) and 58.2% (SE, 2.0). In West European/North American groups, 6-year EFS and overall survival were 49.4% (SE, 2.5) and 62.1% (SE, 2.4), which were 10% to 12% higher than in other countries. The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P = .47). The 6-year EFS rate of patients in the HR group was 20.9% (SE, 3.4) with the intention to undergo SCT; only 46% of them received SCT, because many had early events. KMT2A rearrangement was the strongest prognostic factor for EFS, followed by age, WBC count, and prednisone response. CONCLUSION Early intensification with postinduction myeloid-type chemotherapy courses did not significantly improve outcome for infant ALL compared with the lymphoid-type course IB. Outcome for infant ALL in Interfant-06 did not improve compared with that in Interfant-99.",2019,"The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P =","['651 infants', 'Younger Than 1 Year', 'Infant acute lymphoblastic leukemia (ALL', 'Infants', 'Patients in the MR and HR groups', 'KMT2A germline; high risk (HR): KMT2A -rearranged and older than 6 months with WBC count 300 × 10 9 /L or more or a poor prednisone response; and medium risk (MR']","['lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE', 'Interfant-06 Protocol', 'myeloid-style consolidation chemotherapy']","['6-year event-free survival (EFS) and overall survival', '6-year probability of disease-free survival', '6-year EFS and overall survival', '6-year EFS rate']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",651.0,0.0796176,"The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P =","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Dutch Childhood Oncology Group, Utrecht, the Netherlands.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'De Lorenzo', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ancliffe', 'Affiliation': 'United Kingdom Children Cancer Study Group, London, United Kingdom.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Aversa', 'Affiliation': 'GATLA, Buenos Aires, Argentina.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Brethon', 'Affiliation': 'French Acute Lymphoblastic Leukemia Study Group, Paris, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Chilean National Pediatric Oncology Group, Santiago, Chile.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Escherich', 'Affiliation': 'German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia, Hamburg, Germany.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Children Leukemia Group, Brussels, Belgium.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gardner', 'Affiliation': ""Seattle Children's Hospital and Research Institute, Seattle, WA.""}, {'ForeName': 'Rishi Sury', 'Initials': 'RS', 'LastName': 'Kotecha', 'Affiliation': ""Australian and New Zealand Children's Haematology/Oncology Group, Perth, Australia.""}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Lausen', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Chi Kong', 'Initials': 'CK', 'LastName': 'Li', 'Affiliation': ""The Chinese University of Hong Kong, Shatin, Hong Kong, Special Administrative Region, People's Republic of China.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Andishe', 'Initials': 'A', 'LastName': 'Attarbaschi', 'Affiliation': ""St Anna Children's Hospital, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Children Cancer Research Institute, Vienna, Austria.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lewis B', 'Initials': 'LB', 'LastName': 'Silverman', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stary', 'Affiliation': 'Czech Working Group for Pediatric Hematology, Prague, Czech Republic.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szczepanski', 'Affiliation': 'Polish Pediatric Leukemia/Lymphoma Study Group, Zabrze, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Vora', 'Affiliation': 'United Kingdom Children Cancer Study Group, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Berlin-Frankfurt-Münster Group Germany, Kiel, Germany.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Valsecchi', 'Affiliation': 'University of Milano-Bicocca, Monza, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00261'] 1762,31082269,NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto.,"PURPOSE The GeparSepto trial demonstrated that weekly nanoparticle albumin-bound (NAB)-paclitaxel significantly improves the pathologic complete remission rate compared with weekly solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide as neoadjuvant treatment in patients with primary breast cancer (BC). Here, we report data on long-term outcomes. METHODS Patients with histologically confirmed primary BC were randomly assigned in a 1:1 ratio to 12 times weekly NAB-paclitaxel 150 mg/m 2 (after study amendment, 125 mg/m 2 ) or weekly sb-paclitaxel 80 mg/m 2 followed in both arms by four times epirubicin 90 mg/m 2 plus cyclophosphamide 600 mg/m 2 every 3 weeks. Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received dual antibody treatment with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) concurrently to chemotherapy and continued for 1 year. RESULTS A total of 1,206 patients started treatment, 606 with NAB-paclitaxel and 600 with sb-paclitaxel. After a median follow-up of 49.6 months (range, 0.5 to 64.0 months), 243 invasive disease-free survival (iDFS) events were reported (143 in the sb-paclitaxel and 100 in the NAB-paclitaxel arm). At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m 2 compared with NAB-paclitaxel 150 mg/m 2 . CONCLUSION The significantly higher pathologic complete response rate with NAB-paclitaxel translated into a significantly improved iDFS in patients with early BC as compared with sb-paclitaxel. PSN improved much faster under NAB-paclitaxel 125 mg/m 2 compared with NAB-paclitaxel 150 mg/m 2 .",2019,"At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260).","['patients with primary breast cancer (BC', 'Early Breast Cancer', 'Patients with histologically confirmed primary BC', '1,206 patients started treatment, 606 with', 'Patients with human epidermal growth factor receptor 2 (HER2)-positive BC received']","['nanoparticle albumin-bound (NAB)-paclitaxel', 'dual antibody treatment with trastuzumab', 'sb-paclitaxel 80 mg/m 2 followed in both arms by four times epirubicin 90 mg/m 2 plus cyclophosphamide', 'NAB-paclitaxel and 600 with sb-paclitaxel', 'pertuzumab', 'sb-paclitaxel', 'NAB-paclitaxel', 'solvent-based (sb) paclitaxel followed by epirubicin plus cyclophosphamide', 'NAB-Paclitaxel']","['pathologic complete remission rate', '243 invasive disease-free survival (iDFS) events', 'median time to resolve PSN', 'overall survival', 'iDFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0037638', 'cui_str': 'Solvents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1206.0,0.0837363,"At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Nationales Centrum für Tumorerkrankungen, Heidelberg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'St Elisabeth Krankenhaus Kassel, Kassel, Germany.'}, {'ForeName': 'Bahriye', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': 'Klinik und Poliklinik für Frauenheilkunde Leipzig, Leipzig, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Universitätsklinikum Kiel, Kiel, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wiebringhaus', 'Affiliation': 'St Barbara-Klinik Hamm-Heessen, Hamm, Germany.'}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Warm', 'Affiliation': 'Brustzentrum im Krankenhaus Köln-Holweide, Cologne, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Just', 'Affiliation': 'Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Klinikum zum Roten Kreuz, Munich, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hackmann', 'Affiliation': 'Marien Hospital Witten, Witten, Germany.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Klinik für Gynäkologie am Campus Charité Mitte, Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Uniklinik Köln, Cologne, Germany.'}, {'ForeName': 'Wolfgang D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Universitäts-Frauenklinik, Rostock, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01842'] 1763,31468553,A Positive Youth Development Approach to Improving Mental Health Outcomes for Maltreated Children in Foster Care: Replication and Extension of an RCT of the Fostering Healthy Futures Program.,"Preventing the negative impact of maltreatment on children's mental health requires interventions to be contextually sensitive, grounded in theory and research, and effective in reaching and retaining children and families. This study replicates and extends previous findings of the Fostering Healthy Futures (FHF) program, a 30-week mentoring and skills group intervention for preadolescent maltreated children in foster care. Participants included 426 children recently placed in out-of-home care who were randomized to intervention or control conditions. Outcomes measured 6-10 months postintervention included a multi-informant (child, caregiver, teacher) index of mental health problems as well as measures of posttraumatic stress symptoms, dissociative symptoms, quality of life, and use of mental health services and psychotropic medications. There were high rates of program initiation, retention, and engagement; 95% of those randomized to FHF started the program, 92% completed it, and over 85% of the mentoring visits and skills groups were attended. The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization. These program effects were consistent across almost all subgroups, suggesting that FHF confers benefit for diverse children. Results indicate that positive youth development programming is highly acceptable to children and families and that it can positively impact trauma and its sequelae.",2019,"The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization.","['Maltreated Children in Foster Care', 'Participants included 426 children recently placed in out-of-home care who were randomized to', ""children's mental health"", 'preadolescent maltreated children in foster care']","['FHF', 'intervention or control conditions', 'Fostering Healthy Futures (FHF) program, a 30-week mentoring and skills group intervention']","['multi-informant (child, caregiver, teacher) index of mental health problems as well as measures of posttraumatic stress symptoms, dissociative symptoms, quality of life, and use of mental health services and psychotropic medications', 'Mental Health Outcomes', 'mental health symptomatology, especially trauma symptoms, and mental health service utilization']","[{'cui': 'C0580719', 'cui_str': 'Child in foster care (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0042153', 'cui_str': 'use'}]",426.0,0.0520039,"The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization.","[{'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Taussig', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota - Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Garrido', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Rhodes', 'Affiliation': 'Colorado Department of Education, Denver, CO, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Boat', 'Affiliation': 'The Improve Group, St Paul, MN, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Fadell', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}]",American journal of community psychology,['10.1002/ajcp.12385'] 1764,32030723,A feasibility study of microwave therapy for precancerous actinic keratosis.,"BACKGROUND Actinic keratosis (AK) is a common premalignant skin lesion that can progress to cutaneous squamous cell carcinoma (cSCC). Microwave therapy is an established cancer treatment and has been used for plantar viral warts. OBJECTIVES To evaluate the efficacy and feasibility of microwave as a treatment for AK. METHODS Stage I was a dose-setting study, in which seven participants had the dielectric properties of 12 thick and 22 thin AKs assessed for optimization of the microwave dose used for treatment in Stage II. Stage II was a randomized, internally controlled trial evaluating 179 AKs in 11 patients (93 treated, 86 untreated controls) on the scalp/forehead or dorsal hand. Participants received one treatment initially and a repeat treatment to unresolved AKs at week 4. The response was assessed at six visits over 4 months. The primary outcome was partial or complete resolution of the treated AKs. RESULTS A significantly higher proportion of treated AK areas responded than untreated (90% vs. 15%; P < 0·001). Thin AKs were more responsive than thick AKs. The site did not affect efficacy. Pain was severe, but brief (80% reported pain lasting 'a few seconds only'). Adverse effects were minimal (erythema, n = 6; flaking, n = 3; itch, n = 3). All participants who would chose microwave therapy over their current treatment cited the shorter discomfort period. CONCLUSIONS Microwave therapy is a portable, safe and effective treatment for AK. An easy-to-deliver, acceptable therapy for AK is attractive as a prevention strategy. While these results are promising, a larger randomized controlled trial is needed against an effective comparator to confirm clinical efficacy and patient acceptability. What is already known about this topic? Actinic keratoses (AKs) are common precancerous skin lesions. Successful treatment of AK can prevent cutaneous squamous cell carcinoma (cSCC). Most topical therapies for AK require repeated application over weeks and drive local skin inflammation, leading to poor compliance. An easy-to-deliver and effective treatment for AK, suitable for use in primary care, could reduce cSCC. What does this study add? Microwave therapy is a feasible, effective treatment for AK. Ninety per cent of treated AKs showed full or partial resolution at 120 days post-treatment. Microwave therapy was painful, but the pain was short-lived (seconds) and this short discomfort period was cited as the main reason that microwave was preferred to their current treatment.",2020,"Adverse effects were minimal (redness n=6, flaking n=3, itching n=3).","['11 patients (93 treated, 86 untreated controls) on the scalp/forehead or dorsal hand', 'Stage 1 was a dose-setting study, where seven participants had the dielectric properties of 12 thick and 22 thin AK assessed for optimisation of the microwave dose used for treatment in Stage 2', 'cutaneous squamous cell carcinoma (cSCC', 'Actinic keratosis (AK', 'precancerous actinic keratoses']",['microwave therapy'],"['Pain', 'partial or complete resolution of the treated AK', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin (disorder)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0438673', 'cui_str': 'Microwave diathermy (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",179.0,0.0432819,"Adverse effects were minimal (redness n=6, flaking n=3, itching n=3).","[{'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Jackson', 'Affiliation': 'Department of Dermatology, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Hogarth', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sutherland', 'Affiliation': 'Clinical Research Centre, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Holmes', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, Population Health and Genomics, School of Medicine, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, Population Health and Genomics, School of Medicine, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Proby', 'Affiliation': 'Department of Dermatology, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}]",The British journal of dermatology,['10.1111/bjd.18935'] 1765,31422713,"Effects of vortioxetine on functional capacity across different levels of functional impairment in patients with major depressive disorder: a University of California, San Diego Performance-based Skills Assessment (UPSA) analysis.","Objective: To evaluate the consistency of vortioxetine's effects on functional capacity in adults with major depressive disorder (MDD) and self-reported cognitive symptoms at different levels of functional impairment. Methods: An exploratory analysis of data from a randomized, placebo-controlled, duloxetine-referenced study (NCT01564862) involving 529 patients with moderate to severe MDD treated once-daily with vortioxetine 10/20 mg, duloxetine 60 mg, or placebo for 8 weeks. Analysis of the University of California, San Diego Performance-based Skills Assessment (UPSA) composite scores stratified patients into subgroups by baseline functional impairment and assessed clinically important differences using several cutoffs for change from baseline (CFB) (least-square means) in UPSA composite score. A path analysis was also conducted to determine the proportion of direct versus indirect effects of vortioxetine on functional capacity. Results: Vortioxetine significantly separated from placebo across different baseline levels of functional impairment, particularly at the ≤70 cutoff (mean difference = 5.9, 95% confidence interval, 1.5-10.4). A greater proportion of patients treated with vortioxetine than placebo exhibited UPSA composite score response at each threshold analyzed and were classified as responders based on UPSA CFB of ≥7 ( p  = 0.006) or ≥9 ( p  = 0.016). No significant effects were observed for duloxetine versus placebo for any baseline levels of functional impairment or response thresholds. Path analysis demonstrated that 96.9% of the effects on functional capacity can be directly attributed to the treatment effect of vortioxetine and are not mediated by improvements in depressive symptoms as measured by MADRS. Conclusion: The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD. The effect on functional capacity was largely independent of the effect on depressive symptoms. Trial Registration: ClinicalTrials.gov identifier: NCT01564862: https://clinicaltrials.gov/ct2/show/NCT01564862; European Clinical Trials Database [EudraCT] Number 2011-005298-22: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005298-22/DE.",2020,The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD.,"['patients with major depressive disorder', '529 patients with moderate to severe MDD treated once-daily with', 'patients with MDD', 'adults with major depressive disorder (MDD']","['duloxetine', 'placebo', 'vortioxetine', 'vortioxetine 10/20\u2009mg, duloxetine 60\u2009mg, or placebo', 'Vortioxetine', 'placebo-controlled, duloxetine']","['functional capacity', 'depressive symptoms', 'University of California, San Diego Performance-based Skills Assessment (UPSA) composite scores', 'UPSA composite score response', 'functional impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1702579', 'cui_str': 'duloxetine 60 MG [Cymbalta]'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",529.0,0.625104,The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacobson', 'Affiliation': 'Clinical Science, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'CNS Statistics, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Nomikos', 'Affiliation': 'Clinical Science, Takeda Development Center Americas, Inc, Deerfield, IL, USA.'}, {'ForeName': 'Michael Cronquist', 'Initials': 'MC', 'LastName': 'Christensen', 'Affiliation': 'Trintellix® Medical Affairs, H. Lundbeck a/S, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kurre Olsen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, FL, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, FL, USA.'}]",Current medical research and opinion,['10.1080/03007995.2019.1657692'] 1766,30674700,Adherence therapy for schizophrenia: a randomised controlled trial.,,2019,,['schizophrenia'],['Adherence therapy'],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.26051,,"[{'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'Nethersole School of Nursing, The Chinese University of Hong Kong.'}, {'ForeName': 'E F C', 'Initials': 'EFC', 'LastName': 'Cheung', 'Affiliation': 'Castle Peak Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'J H C', 'Initials': 'JHC', 'LastName': 'Mui', 'Affiliation': 'Castle Peak Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Faculty of Medicine & Health Sciences, University of East Anglia, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ip', 'Affiliation': 'Kwai Chung Hospital, Hospital Authority, Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 1767,30674705,Combined electroacupuncture and auricular acupuncture for primary insomnia: a randomised controlled trial of dose-response effect.,,2019,,['primary insomnia'],['electroacupuncture and auricular acupuncture'],[],"[{'cui': 'C0033139', 'cui_str': 'Primary Insomnia'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0752217', 'cui_str': 'Auricular Acupuncture'}]",[],,0.362996,,"[{'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong.'}, {'ForeName': 'W F', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}, {'ForeName': 'B Y M', 'Initials': 'BYM', 'LastName': 'Yu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University.'}, {'ForeName': 'Z J', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 1768,31462136,Home-based tele-rehabilitation presents comparable positive impact on self-reported functional outcomes as usual care: The Singapore Tele-technology Aided Rehabilitation in Stroke randomised trial.,"INTRODUCTION The aim of this research was to evaluate the impact of a novel tele-rehabilitation system on self-reported functional outcomes compared to usual care during the first three months after stroke. METHODS A parallel, two-arm, evaluator-blinded, randomised controlled trial was conducted. Adults aged ≥40 years who had suffered a stroke within four weeks of the start of the study were recruited from the general community. The intervention group received access to a novel tele-rehabilitation system and programme for three months. The primary outcome measures utilised were the frequency and limitation total scores of the Late-Life Function and Disability Instrument (LLFDI) at three months. RESULTS A total of 124 individuals were recruited. The mean differences in the LLDFI frequency and limitation total scores at three months comparing the intervention and control groups were -3.30 (95% confidence interval (CI) -7.81 to 1.21) and -6.90 (95% CI -15.02 to 1.22), respectively. Adjusting for the respective baseline covariates and baseline Barthel Index also showed no significant difference between interventions in the LLFDI outcomes. DISCUSSION The intervention and control groups self-reported similar improvements in functional outcomes. Tele-rehabilitation may be a viable option to provide post-stroke rehabilitation services in Singapore while reducing barriers to continue rehabilitation conventionally after discharge from hospital and encouraging more participation.",2019,,[],['Home-based tele-rehabilitation'],[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}]",[],,0.0492954,,"[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Asano', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Bee C', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Felicity Yt', 'Initials': 'FY', 'LastName': 'Yeo', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}, {'ForeName': 'Shi C', 'Initials': 'SC', 'LastName': 'Yen', 'Affiliation': 'Department of Electrical and Computer Engineering, National University of Singapore, Singapore.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Department of Electrical and Computer Engineering, National University of Singapore, Singapore.'}, {'ForeName': 'Yee S', 'Initials': 'YS', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Deidre A', 'Initials': 'DA', 'LastName': 'De Silva', 'Affiliation': 'Department of Neurology, National Neuroscience Institute, Singapore.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Caves', 'Affiliation': 'Department of Surgery, Duke University Medical Center, USA.'}, {'ForeName': 'Eiffie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': 'Department of Rehabilitation Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hoenig', 'Affiliation': 'Physical Medicine and Rehabilitation Service, Durham Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Gerald C', 'Initials': 'GC', 'LastName': 'Koh', 'Affiliation': 'National University of Singapore, Saw Swee Hock School of Public Health, Singapore.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19868905'] 1769,10911825,Randomized controlled trial of nettle sting for treatment of base-of-thumb pain.,"There are numerous published references to use of nettle sting for arthritis pain but no randomized controlled trials have been reported. We conducted a randomized controlled double-blind crossover study in 27 patients with osteoarthritic pain at the base of the thumb or index finger. Patients applied stinging nettle leaf (Urtica dioica) daily for one week to the painful area. The effect of this treatment was compared with that of placebo, white deadnettle leaf (Lamium album), for one week after a five-week washout period. Observations of pain and disability were recorded for the twelve weeks of the study. After one week's treatment with nettle sting, score reductions on both visual analogue scale (pain) and health assessment questionnaire (disability) were significantly greater than with placebo (P = 0.026 and P = 0.0027).",2000,"After one week's treatment with nettle sting, score reductions on both visual analogue scale (pain) and health assessment questionnaire (disability) were significantly greater than with placebo (P = 0.026 and P = 0.0027).",['27 patients with osteoarthritic pain at the base of the thumb or index finger'],"['placebo', 'placebo, white deadnettle leaf (Lamium album']","['visual analogue scale (pain) and health assessment questionnaire (disability', 'pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0230388', 'cui_str': 'Index finger structure'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0242724', 'cui_str': 'Plant Leaves'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",27.0,0.161051,"After one week's treatment with nettle sting, score reductions on both visual analogue scale (pain) and health assessment questionnaire (disability) were significantly greater than with placebo (P = 0.026 and P = 0.0027).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Randall', 'Affiliation': 'Department of Primary Health Care and General Practice, Plymouth Postgraduate Medical School, University of Plymouth, Devon, UK. colin@cfrandall.freeserve.co.uk'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Randall', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dobbs', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hutton', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sanders', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1770,31194613,Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR -Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study.,"PURPOSE To assess the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as neoadjuvant/adjuvant therapies in locally advanced EGFR mutation-positive non-small-cell lung cancer. PATIENTS AND METHODS This was a multicenter (17 centers in China), open-label, phase II, randomized controlled trial of erlotinib versus gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non-small-cell lung cancer with EGFR mutations in exon 19 or 21 (EMERGING). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m 2 plus cisplatin 75 mg/m 2 (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postsurgery. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability. RESULTS Of 386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment). The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54.1% versus 34.3% (odds ratio, 2.26; 95% CI, 0.87 to 5.84; P = .092). No pathologic complete response was identified in either arm. Three (9.7%) of 31 patients and zero of 23 patients in the erlotinib and GC chemotherapy arms, respectively, had a major pathologic response. Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67; P < .001). Observed adverse events reflected those most commonly seen with the two treatments. CONCLUSION The primary end point of ORR with 42 days of neoadjuvant erlotinib was not met, but the secondary end point PFS was significantly improved.",2019,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67; P < .001).","['multicenter (17 centers in China), open-label, phase II', 'patients with stage IIIA-N2 non-small-cell lung cancer with EGFR mutations in exon 19 or 21', '386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment']","['erlotinib versus gemcitabine plus cisplatin (GC chemotherapy', 'epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors', 'Erlotinib Versus Gemcitabine Plus Cisplatin', 'erlotinib 150 mg/d (neoadjuvant therapy', 'GC chemotherapy', 'gemcitabine 1,250 mg/m 2 plus cisplatin 75 mg/m 2 (neoadjuvant therapy']","['major pathologic response', 'objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors', 'pathologic complete response', 'ORR', 'pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability', 'Median PFS']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2978152', 'cui_str': 'erlotinib 150 MG [Tarceva]'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",72.0,0.11076,"Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67; P < .001).","[{'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Chun-Dong', 'Initials': 'CD', 'LastName': 'Gu', 'Affiliation': ""First Affiliated Hospital of Dalian Medical University, Dalian, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': ""Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Zhongshan Hospital, Shanghai, People's Republic of China.""}, {'ForeName': 'Gui-Bin', 'Initials': 'GB', 'LastName': 'Qiao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Jilin Provincial Tumor Hospital, Changchun, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Jiangsu Cancer Institute and Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Chang-Li', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Chen', 'Affiliation': ""First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xiaozheng', 'Initials': 'X', 'LastName': 'Kang', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wanpu', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ri-Qiang', 'Initials': 'RQ', 'LastName': 'Liao', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jin-Ji', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xu-Chao', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00075'] 1771,10844878,A randomized controlled study of reviewer bias against an unconventional therapy.,"A study was designed to test the hypothesis that experts who review papers for publication are prejudiced against an unconventional form of therapy. Two versions were produced (A and B) of a 'short report' that related to treatments of obesity, identical except for the nature of the intervention. Version A related to an orthodox treatment, version B to an unconventional treatment. 398 reviewers were randomized to receive one or the other version for peer review. The primary outcomes were the reviewers' rating of 'importance' on a scale of 1-5 and their verdict regarding rejection or acceptance of the paper. Reviewers were unaware that they were taking part in a study. The overall response rate was 41.7%, and 141 assessment forms were suitable for statistical evaluation. After dichotomization of the rating scale, a significant difference in favour of the orthodox version with an odds ratio of 3.01 (95% confidence interval, 1.03 to 8.25), was found. This observation mirrored that of the visual analogue scale for which the respective medians and interquartile ranges were 67% (51% to 78.5%) for version A and 57% (29.7% to 72.6%) for version B. Reviewers showed a wide range of responses to both versions of the paper, with a significant bias in favour of the orthodox version. Authors of technically good unconventional papers may therefore be at a disadvantage in the peer review process. Yet the effect is probably too small to preclude publication of their work in peer-reviewed orthodox journals.",2000,"This observation mirrored that of the visual analogue scale for which the respective medians and interquartile ranges were 67% (51% to 78.5%) for version A and 57% (29.7% to 72.6%) for version B. Reviewers showed a wide range of responses to both versions of the paper, with a significant bias in favour of the orthodox version.",['398 reviewers'],['unconventional therapy'],"["" rating of 'importance' on a scale of 1-5 and their verdict regarding rejection or acceptance of the paper"", 'overall response rate', 'visual analogue scale']",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",398.0,0.0308147,"This observation mirrored that of the visual analogue scale for which the respective medians and interquartile ranges were 67% (51% to 78.5%) for version A and 57% (29.7% to 72.6%) for version B. Reviewers showed a wide range of responses to both versions of the paper, with a significant bias in favour of the orthodox version.","[{'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Resch', 'Affiliation': 'Forschungsinstitut für Balneologie und Kurortwissenschaft, Bad Elster, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garrow', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1772,31460693,"Incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: Data from the CTO-IVUS randomized trial.","OBJECTIVES To evaluate the incidence, predictors, and outcomes of distal vessel expansion on intravascular ultrasound (IVUS) after recanalization of chronic total occlusion (CTO) particularly using new-generation drug-eluting stent (DES). BACKGROUND The luminal changes of narrowed vessels distal to CTO segments after recanalization using new-generation DES have rarely been studied. METHODS This substudy of the CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents) trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up. The predictors of distal vessel expansion, any increase of lumen area at the distal reference (LA distal ) on 1-year follow-up IVUS, were evaluated by multivariable binary logistic analyses. RESULTS Distal vessel expansion was identified in 46 (67%). Independent determinants of distal vessel expansion were proximal CTO, a smaller LA distal at the index PCI, a greater minimal stent area-to-LA distal (MSA-to-LA distal ) ratio, and a greater lumen area at the distal stent edge-to-LA distal (LA edge -to-LA distal ) ratio. The cut-off values of a MSA-to-LA distal ratio and a LA edge -to-LA distal ratio predicting the distal vessel expansion by receiver operating characteristic curve analysis were 1.0 and 1.1, respectively. During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups. CONCLUSION After opening CTO with new-generation DES, two-thirds of patients exhibited distal vessel expansion on 1-year follow-up IVUS. Expansion determinants were a proximal CTO, lower LA distal , and larger stent areas relative to the LA distal (modifiable procedural predictors).",2020,"During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups. ",['trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up'],"['intravascular ultrasound (IVUS', 'CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents']","['exhibited distal vessel expansion', 'distal vessel expansion', 'Distal vessel expansion', 'rates of target vessel revascularization, cardiac death, and stent thrombosis']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}]","[{'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.0320893,"During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups. ","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung-Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'Hee-Yeol', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': ""Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, South Korea.""}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Doonghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28461'] 1773,17021304,The MRC randomized trial of streptomycin and its legacy: a view from the clinical front line.,,2006,,[],['streptomycin and its legacy'],[],[],"[{'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C2979241', 'cui_str': 'Legacy'}]",[],,0.0212347,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Crofton', 'Affiliation': '13 Spylaw Bank Road, Colinton, Edinburgh EH13 0JW, UK. eapretty@breathemail.net'}]",Journal of the Royal Society of Medicine,[] 1774,31460865,A contingency management intervention to reduce cannabis use and time to relapse in early psychosis: the CIRCLE RCT.,"BACKGROUND Cannabis is the most prevalent illicit substance among people with psychosis, and its use is associated with poorer clinical and social outcomes. However, so far, there has been limited evidence that any treatment is effective for reducing use. Contingency management (CM) is an incentive-based intervention for substance misuse that has a substantial evidence base across a range of substances and cohorts. However, to date there have been no randomised controlled trials (RCTs) of CM as a treatment for cannabis use specifically in psychosis. OBJECTIVE To conduct a RCT investigating the clinical effectiveness and cost-effectiveness of CM in reducing cannabis use among Early Intervention in Psychosis (EIP) service users. DESIGN The CIRCLE (Contingency Intervention for Reduction of Cannabis in Early Psychosis) trial was a rater-blinded, multicentre RCT with two arms. Participants were randomised 1 : 1 to either an CM arm, in which participants received CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only. SETTING EIP services across the Midlands and the south-east of England. PARTICIPANTS The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks. INTERVENTION The CM intervention offered financial incentives (i.e. shopping vouchers) for cannabis abstinence over 12 once-weekly sessions, confirmed using urinalysis. The maximum value in vouchers that participants could receive was £240. MAIN OUTCOME MEASURES The main outcome was time to relapse, operationalised as admission to an acute mental health service or hospital. The primary outcome was assessed at 18 months post inclusion using electronic patient records. Secondary outcomes assessed the clinical effectiveness and cost-effectiveness of the intervention, for which data were collected at 3 and 18 months. RESULTS A total of 278 participants were randomised to the CM arm and 273 were randomised to the control arm. In total, 530 (96%) participants were followed up for the primary outcome. There was no significant difference in time to admission between trial arms by 18 months following consent (hazard ratio 1.03, 95% confidence interval 0.76 to 1.40). There were no statistically significant differences in most secondary outcomes, including cannabis use, at either follow-up assessment. There were 58 serious adverse events, comprising 52 inpatient episodes, five deaths and one arrest. LIMITATIONS Participant retention was low at 18 months, limiting the assessment of secondary outcomes. A different CM intervention design or reward level may have been effective. CONCLUSIONS The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use. FUTURE WORK Cannabis use is still a significant clinical concern in this population. A pressing need remains to identify suitable treatments. A wider perspective on the social circumstances of young people with psychosis may be needed for a successful intervention to be found. TRIAL REGISTRATION Current Controlled Trials ISRCTN33576045. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 45. See the NIHR Journals Library website for further project information.",2019,"The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use. ","['278 participants', 'early psychosis', 'Psychosis (EIP) service users', 'young people with psychosis', 'The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks', 'EIP services across the Midlands and the south-east of England']","['CM', 'CIRCLE (Contingency Intervention', 'CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only', 'contingency management intervention', 'Contingency management (CM']","['clinical effectiveness and cost-effectiveness of the intervention, for which data', '58 serious adverse events', 'time to admission', '52 inpatient episodes, five deaths and one arrest', 'cannabis use and acute relapse', 'time to relapse, operationalised as admission to an acute mental health service or hospital']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3887134', 'cui_str': 'History of psychosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",278.0,0.342918,"The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use. ","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Luke Sheridan', 'Initials': 'LS', 'LastName': 'Rains', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Marwaha', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Mental Health, Social Work and Interprofessional Learning, Middlesex University, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Health Service and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Clinical Psychology and Clinical Effectiveness, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health and PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Rumana Z', 'Initials': 'RZ', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Spencer', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hinton', 'Affiliation': 'Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23450'] 1775,32441302,Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial.,"Ultrasound-guided costoclavicular block (CC-approach) is a recently described brachial plexus block (BPB) and an alternative approach to the supraclavicular approach (SC-approach). The relevant sonoanatomy is analogous in terms of the brachial plexus and its adjacent artery for both approaches. In the present study, we hypothesized that the two approaches will result in similar block dynamics when used the modified double-injection (MDI) technique. One hundred and twelve patients were randomly allocated to receive either a SC- or CC-approach with MDI technique. In the CC group, half the volume was injected adjacent to the medial cord of the brachial plexus, the procedure was guided by ultrasound and verified by nerve stimulator, subsequently the second half was injected close to the lateral cord. In the SC group, the MDI technique was carried out as described in our previous study. Sensory and motor blockade of all four terminal nerves were assessed with a 3-point scale. The primary outcome was the proportion of complete sensory blockade at 15 min with a predefined non-inferiority margin of -13%. The proportion of subjects at 15 min was comparable between the SC group and the CC group (91 vs 87%, absolute difference: -3%). No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05). We conclude that the MDI technique applied to a costoclavicular and supraclavicular block resulted in similar block dynamics. In addition, it may provide a promising alternative technique when considering the use of multipoint injection.",2020,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).",['112 patients'],"['SC- or CC-approach with MDI technique', 'ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique', 'Ultrasound-guided costoclavicular block (CC-approach']","['proportion of complete sensory blockade', 'complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.0308918,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).","[{'ForeName': 'Quehua', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'HaiHua', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}]",Bioscience reports,['10.1042/BSR20200084'] 1776,30768394,A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual.,"OBJECTIVE This single-blind, randomized, multisite, intent-to-treat study was designed to replicate and extend Dawson et al.'s (Pediatrics. 2010;125: e17-e23) randomized controlled trial testing the effects of the Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings. METHOD A randomized controlled trial was conducted at 3 universities. One hundred eighteen children 14 to 24 months old with autism spectrum disorder were enrolled and randomly assigned to ESDM or community interventions for 27 months. Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses. Children assigned to the ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist. RESULTS For the primary analyses, there were time-by-group and time-by-group-by-site interactions for language outcome. In the significant 3-way interaction involving site, 2 sites showed a significant ESDM advantage and the third site showed no significant group differences. In the planned 2-way analysis that pooled data across all 3 sites, there was a significant advantage found for the ESDM group. For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior. The treatment effect of group on language outcomes was not moderated by baseline developmental quotient, autism severity, or language. CONCLUSION Results of the primary analysis provide a partial replication of Dawson et al.'s 2010 language findings. CLINICAL TRIAL REGISTRATION INFORMATION Intensive Intervention for Toddlers with Autism; https://clinicaltrials.gov/; NCT00698997.",2019,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","['Toddlers with Autism', 'One hundred eighteen children 14 to 24 months old with autism spectrum disorder', 'Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses']","['ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist', 'Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings', 'ESDM or community interventions']","['baseline developmental quotient, autism severity, or language', 'partial replication of Dawson et', 'developmental quotient, autism severity, or adaptive behavior']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}]",118.0,0.195291,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","[{'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento. Electronic address: sjrogers@ucdavis.edu.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lord', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greenson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Colombi', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Whelan', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.004'] 1777,31290573,"A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).","BACKGROUND Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval. STUDY DESIGN AND METHODS The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought. RESULTS A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group. CONCLUSION In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.",2019,"There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function.","['73 patients', 'high-risk cardiothoracic surgical patients in four Australian hospitals', 'A total of 121 patients']","['cryopreserved platelets', 'Cryopreserved vs. Liquid Platelet (CLIP', 'cryopreserved PLTs and 18 received liquid-stored PLTs']","['perioperative surgical bleeding', 'blood loss', 'Red blood cell transfusion requirements', 'Adverse events', 'postoperative hemorrhage in cardiac surgery composite bleeding endpoint', 'postoperative length of stay', 'feasibility and safety', 'transfused fresh-frozen plasma', 'potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",121.0,0.428619,"There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Reade', 'Affiliation': 'Joint Health Command, Australian Defence Force, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Denese C', 'Initials': 'DC', 'LastName': 'Marks', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Deans', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Faulke', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Holley', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Irving', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bronwyn L', 'Initials': 'BL', 'LastName': 'Pearse', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alistair G', 'Initials': 'AG', 'LastName': 'Royse', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15423'] 1778,31451351,Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis.,"BACKGROUND Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung. METHODS Eligible patients with forced expiratory volume in 1 s (FEV 1 ) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV 1 (per-protocol population). Secondary endpoints included change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R). RESULTS The study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1 (L) from baseline. The mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms. Treatment-emergent adverse events (TEAEs) were reported in most patients (ALIS, 84.5%; TIS, 78.8%). Serious TEAEs occurred in 17.6% and 19.9% of patients, respectively; most were hospitalisations for infective pulmonary exacerbation of CF. CONCLUSIONS Cyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.",2020,"ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1 (L) from baseline.","['February 2012 to September 2013', 'chronic Pseudomonas aeruginosa infection in cystic fibrosis', 'Eligible patients with forced expiratory volume in 1\u202fs (FEV 1 ) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection', 'patients with cystic fibrosis (CF']","['Amikacin liposome inhalation suspension', 'inhaled antibiotic treatments', 'amikacin liposome inhalation suspension (ALIS, 590\u202fmg QD) or tobramycin inhalation solution (TIS, 300\u202fmg BID']","['change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R', 'noninferiority of ALIS vs TIS', 'Serious TEAEs', 'lung function', 'CFQ-R score']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1154181', 'cui_str': 'Inhalation Solution'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.117115,"ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1 (L) from baseline.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bilton', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Tacjana', 'Initials': 'T', 'LastName': 'Pressler', 'Affiliation': 'Rigshospitalet (Hospital), Copenhagen, Denmark.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fajac', 'Affiliation': 'AP-HP, Université Paris Descartes, Paris, France.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Clancy', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Sands', 'Affiliation': 'Cystic Fibrosis Department, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Minic', 'Affiliation': 'Institute for Mother and Child Health Care, Department of Pulmonology, Medical School University of Belgrade, Serbia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cipolli', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Galeva', 'Affiliation': 'Pediatric Clinic, Infants Department, Alexandrovska University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Solé', 'Affiliation': 'Lung Transplant and Cystic Fibrosis Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Quittner', 'Affiliation': 'University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McGinnis', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Eagle', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Konstan', 'Affiliation': ""Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH, USA. Electronic address: Michael.Konstan@case.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.08.001'] 1779,31445582,Intradialytic nutrition and exercise: convenience versus efficacy.,"Jeong et al. reported the results of a randomized controlled trial in patients on hemodialysis in which intradialytic protein supplementation, with or without exercise, failed to show any beneficial effect on physical function, vascular health, and nutritional markers. These data provide an opportunity to reconsider the appropriate strategy to gain the most benefit from these otherwise proven interventions, that is, prescribing the right intervention for the right patient, at the right dose and at the right time.",2019,"These data provide an opportunity to reconsider the appropriate strategy to gain the most benefit from these otherwise proven interventions, that is, prescribing the right intervention for the right patient, at the right dose and at the right time.",[],[],"['physical function, vascular health, and nutritional markers']",[],[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0338793,"These data provide an opportunity to reconsider the appropriate strategy to gain the most benefit from these otherwise proven interventions, that is, prescribing the right intervention for the right patient, at the right dose and at the right time.","[{'ForeName': 'T Alp', 'Initials': 'TA', 'LastName': 'Ikizler', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA. Electronic address: alp.ikizler@vanderbilt.edu.'}]",Kidney international,['10.1016/j.kint.2019.04.037'] 1780,31449735,Radiofrequency ablation of turbinates after septoplasty has no effect on allergic rhinitis symptoms other than nasal obstruction.,"BACKGROUND In this study we evaluated the effects of inferior turbinate radiofrequency ablation (RFA), performed after septoplasty, on patients with allergic rhinitis (AR) symptoms. METHODS This was a prospective, randomized, controlled study involving 60 patients with both a deviated nasal septum (DNS) and AR. Those who underwent septoplasty/sham surgery constituted the Septo-Sham group and those who underwent septoplasty/RFA formed the Septo-RFA group. Demographic factors, pre- and postoperative symptom scores for allergic rhinitis (SFARs), and Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) scores were calculated. We subdivided the total SFAR (tSFAR) scores into scores for nasal obstruction (SFAR-NO) and scores for symptoms other than nasal obstruction (SFAR-SONO); the latter included rhinorrhea, itching, and sneezing. RESULTS The baseline characteristics were similar between the groups. The 2 types of surgery improved both the NOSE and SFAR scores. In subgroup analysis according to the type of symptoms, both types of surgery showed improvement in SFAR-NO and SFAR-SONO scores. However, the extent of improvement did not differ between the groups, regardless of the type of symptoms. CONCLUSION For patients with both DNS and AR, both types of surgery afford postoperative symptomatic improvement. Both types of surgery yielded improvement in both nasal obstruction and symptoms other than nasal obstruction. However, performing RFA after septoplasty did not afford further short-term symptomatic improvements. Thus, septoplasty without RFA may be optimal for patients with both DNS and AR.",2019,The 2 types of surgery improved both the NOSE and SFAR scores.,"['patients with both DNS and AR', '60 patients with both a deviated nasal septum (DNS) and AR', 'patients with allergic rhinitis (AR) symptoms']","['septoplasty/sham surgery constituted the Septo-Sham group and those who underwent septoplasty/RFA', 'inferior turbinate radiofrequency ablation (RFA', 'Radiofrequency ablation']","['allergic rhinitis symptoms', 'total SFAR (tSFAR) scores into scores for nasal obstruction (SFAR-NO) and scores for symptoms other than nasal obstruction (SFAR-SONO); the latter included rhinorrhea, itching, and sneezing', 'SFAR-NO and SFAR-SONO scores', 'nasal obstruction and symptoms', 'Demographic factors, pre- and postoperative symptom scores for allergic rhinitis (SFARs), and Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) scores', 'NOSE and SFAR scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum (disorder)'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0225434', 'cui_str': 'Inferior turbinated bone'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0037383', 'cui_str': 'Sneezings'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0028429', 'cui_str': 'Nose'}]",60.0,0.0363327,The 2 types of surgery improved both the NOSE and SFAR scores.,"[{'ForeName': 'Taegu', 'Initials': 'T', 'LastName': 'Kang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Chonnam National University Medical School and Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Chung Man', 'Initials': 'CM', 'LastName': 'Sung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Chonnam National University Medical School and Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Hyung Chae', 'Initials': 'HC', 'LastName': 'Yang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Chonnam National University Medical School and Chonnam National University Hospital, Gwangju, South Korea.'}]",International forum of allergy & rhinology,['10.1002/alr.22420'] 1781,31451419,"Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study.","BACKGROUND Use of single-bed rooms for control of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae is under debate; the added value when applying contact precautions has not been shown. We aimed to assess whether an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae. METHODS We did a cluster-randomised, crossover, non-inferiority study on medical and surgical wards of 16 Dutch hospitals. During two consecutive study periods, either contact precautions in a single-bed room or contact precautions in a multiple-bed room were applied as the preferred isolation strategy for patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients). Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram. Hospitals were randomly assigned in a 1:1 ratio by computer to one of two sequences of isolation strategies, stratified by university or non-university hospital. Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients. The primary outcome was transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBL-producing Enterobacteriaceae isolate that was clonally related to the index patient's isolate in at least one wardmate. The primary analysis was done in the per-protocol population, which included patients who were adherent to the assigned room type. A 10% non-inferiority margin for the risk difference was used to assess non-inferiority. This study is registered with Nederlands Trialregister, NTR2799. FINDINGS 16 hospitals were randomised, eight to each sequence of isolation strategies. All hospitals randomised to the sequence single-bed room then multiple-bed room and five of eight hospitals randomised to the sequence multiple-bed room then single-bed room completed both study periods and were analysed. From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12 875 wardmates were assessed for eligibility. Of those, 693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population. Transmission of ESBL-producing Enterobacteriaceae to at least one wardmate was identified for 11 (4%) of 275 index patients during the single-bed room strategy period and for 14 (7%) of 188 index patients during the multiple-bed room strategy period (crude risk difference 3·4%, 90% CI -0·3 to 7·1). INTERPRETATION For patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample, an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae. Non-inferiority of the multiple-bed room strategy might change the current single-bed room preference for isolation of patients with ESBL-producing Enterobacteriaceae and, thus, broaden infection-control options for ESBL-producing Enterobacteriaceae in daily clinical practice. FUNDING Netherlands Organisation for Health Research and Development.",2019,"Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients.","['patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients', '693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population', '16 hospitals', 'medical and surgical wards of 16 Dutch hospitals', 'patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals', 'Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram', 'From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12\u2008875 wardmates were assessed for eligibility']",[],"['transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBL-producing Enterobacteriaceae isolate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1720786', 'cui_str': 'Antibiogram'}, {'cui': 'C4517897', 'cui_str': '875'}]",[],"[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1444096', 'cui_str': 'Extended spectrum beta-lactamase producing bacteria'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}]",693.0,0.091772,"Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients.","[{'ForeName': 'Marjolein F Q', 'Initials': 'MFQ', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Department of Infection Control, Amphia Hospital, Breda, Netherlands; Amphia Academy Infectious Disease Foundation, Amphia Hospital, Breda, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands. Electronic address: marjoleinkluytmans@gmail.com.'}, {'ForeName': 'Patricia C J', 'Initials': 'PCJ', 'LastName': 'Bruijning-Verhagen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Christina M J E', 'Initials': 'CMJE', 'LastName': 'Vandenbroucke-Grauls', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Els I G B', 'Initials': 'EIGB', 'LastName': 'de Brauwer', 'Affiliation': 'Department of Medical Microbiology, Atrium Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'Anton G M', 'Initials': 'AGM', 'LastName': 'Buiting', 'Affiliation': 'Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Bram M', 'Initials': 'BM', 'LastName': 'Diederen', 'Affiliation': 'Regional Laboratory of Public Health, Haarlem, Netherlands; Microvida Laboratory for Microbiology, Bravis Hospital, Roosendaal, Netherlands.'}, {'ForeName': 'Erika P M', 'Initials': 'EPM', 'LastName': 'van Elzakker', 'Affiliation': 'Department of Microbiology, Haga Hospital, The Hague, Netherlands.'}, {'ForeName': 'Alex W', 'Initials': 'AW', 'LastName': 'Friedrich', 'Affiliation': 'Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Hopman', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Nashwan', 'Initials': 'N', 'LastName': 'Al Naiemi', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Ziekenhuisgroep Twente, Almelo/Hengelo, Netherlands.'}, {'ForeName': 'John W A', 'Initials': 'JWA', 'LastName': 'Rossen', 'Affiliation': 'Department of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Gijs J H M', 'Initials': 'GJHM', 'LastName': 'Ruijs', 'Affiliation': 'Laboratory for Microbiology and Infectious Diseases, Isala Clinics, Zwolle, Netherlands.'}, {'ForeName': 'Paul H M', 'Initials': 'PHM', 'LastName': 'Savelkoul', 'Affiliation': 'Department of Medical Microbiology and Infection Control, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Medical Microbiology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Verhulst', 'Affiliation': 'Microvida Laboratory for Microbiology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Voss', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, Netherlands; Department of Medical Microbiology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Jan A J W', 'Initials': 'JAJW', 'LastName': 'Kluytmans', 'Affiliation': 'Department of Infection Control, Amphia Hospital, Breda, Netherlands; Microvida Laboratory for Microbiology, Amphia Hospital, Breda, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30262-2'] 1782,31424957,"The Evaluation of TUNEL, PCNA and SOX2 Expressions in Lens Epithelial Cells of Cataract Patients with Pseudoexfoliation Syndrome.","Purpose : This study aims to determine the expression patterns of terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling (TUNEL), proliferating cell nuclear antigen (PCNA) and SOX2 in lens epithelial cells (LEC) of cataract patients with pseudoexfoliation syndrome (PEX), and to determine the effect of apoptosis, proliferative activity and stem/progenitor cells on cataract formation in patients with PEX. This is a prospective, randomized clinical trial. Materials and Methods : Setting: institutional. 50 eyes of 50 patients were included. Anterior capsule samples were obtained during phacoemulsification surgery. The specimens of LEC were also examined using the TUNEL, PCNA and SOX2 immunohistochemical staining method. To detect the number of immunopositive cells, the total number of cells in a 3 mm 2 area was counted using a microscope under x20 magnification and the percentage of cells stained positive was determined. Results : In Group 1, increased expression was observed with TUNEL, while decreased expression was detected with PCNA ( p = .008, p = .015). The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44). Apoptosis rates were 61.75 ± 14.5% and 36.91 ± 14.6% in Groups 1 and 2, respectively. Proliferation rates were 40.96 ± 16.8% and 65.45 ± 16.9% in Groups 1 and 2, respectively. Conclusion : We found increased apoptosis and decreased proliferation of LECs in cataract patients with PEX. We suspected that this could be related to oxidative stress.",2020,"The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44).","['cataract patients with PEX', '50 eyes of 50 patients were included', 'patients with PEX', 'Cataract Patients with Pseudoexfoliation Syndrome', 'cataract patients with pseudoexfoliation syndrome (PEX']","['Materials and Methods ', 'terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling (TUNEL), proliferating cell nuclear antigen (PCNA) and SOX2']","['Proliferation rates', 'expression', 'average percentage of TUNEL immunopositive cells', 'proliferation of LECs', 'Apoptosis rates', 'meaningful SOX2 expression', 'number of immunopositive cells, the total number of cells', 'increased expression']","[{'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0687124', 'cui_str': 'Terminal deoxynucleotidyl transferase stain'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0072108', 'cui_str': 'PCNA'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0600528', 'cui_str': 'TUNEL'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",50.0,0.0445749,"The average percentage of TUNEL immunopositive cells was significantly higher in Group 1 than in Group 2, but there was no statistically meaningful SOX2 expression in Group 1 and Group 2 ( P = .44).","[{'ForeName': 'Gulay', 'Initials': 'G', 'LastName': 'Turan', 'Affiliation': 'Faculty of Medicine, Department of Pathology, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Meydan', 'Initials': 'M', 'LastName': 'Turan', 'Affiliation': 'Department of Ophthalmology, Balikesir Ataturk City Hospital, Balikesir, Turkey.'}]",Current eye research,['10.1080/02713683.2019.1657463'] 1783,31155474,Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial.,"BACKGROUND Dietary self-monitoring (DSM) of foods and beverages is associated with weight loss in behavioral interventions; however, DSM may be burdensome, and adherence may decrease over time. Novel methods of DSM, including apps that track food using photographs, may decrease burden, increase DSM adherence, and improve weight loss. OBJECTIVE The objective was to test a mobile photo DSM app compared to a calorie-tracking DSM app on tracking frequency and weight loss in a remotely delivered behavioral weight-loss intervention. DESIGN This was a 6-month (October 2016 to April 2017) randomized trial. PARTICIPANTS/SETTING Participants were adults (n=41) classified as overweight or obese (body mass index 25 to 49.9) from South Carolina. INTERVENTION Participants received remotely delivered twice-weekly behavioral weight-loss podcasts and tracked diet using a calorie-tracking DSM app (Calorie Group) or a photo DSM app (Photo Group). MAIN OUTCOME MEASURES Main outcomes were the number of days diet was tracked, podcasts downloaded, and weight change at 6 weeks and 6 months. STATISTICAL ANALYSES Researchers used nonparametric Wilcoxon rank sum tests and χ 2 analysis to test for differences between groups at baseline; repeated-measures models to estimate weight change and Spearman correlations to determine relationships between DSM frequency, podcasts downloaded, and weight change at 6 months. RESULTS There were no differences between groups for the number of days that diet was recorded (P=0.18), which was low overall (<30% of days) but was statistically significantly and strongly correlated with weight change for all participants pooled (r=0.63; P<0.001) and for the calorie tracking group (r=0.70; P=0.004), but not the photo tracking group (r=0.51; P=0.06). Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74). CONCLUSIONS As part of a remotely delivered weight loss intervention, frequency of DSM was significantly associated with overall weight loss for participants using a calorie DSM app but not a photo DSM app. DSM was low regardless of group and weight loss was significant, although minimal. Increasing user engagement with any DSM may be important to increase self-monitoring and improve weight loss.",2019,"Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74). ",['Participants were adults (n=41) classified as overweight or obese (body mass index 25 to 49.9) from South Carolina'],"['Participants received remotely delivered twice-weekly behavioral weight-loss podcasts and tracked diet using a calorie-tracking DSM app (Calorie Group) or a photo DSM app (Photo Group', 'calorie-tracking DSM']","['number of days diet was tracked, podcasts downloaded, and weight change', 'weight loss', 'DSM adherence', 'Weight Loss', 'overall weight loss', 'weight change', 'number of days that diet']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}]","[{'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0313166,"Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74). ","[{'ForeName': 'Caroline Glagola', 'Initials': 'CG', 'LastName': 'Dunn', 'Affiliation': ''}, {'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.013'] 1784,30611756,The effect of expectation on transcranial direct current stimulation (tDCS) to suppress food craving and eating in individuals with overweight and obesity.,"Transcranial direct current stimulation (tDCS) is a neuromodulation technique with potential to treat eating disorders and obesity. As for any potential treatment, it is important to assess the degree to which expectation effects contribute to its reported efficacy. This study assessed the effect of tDCS on amount of food craving and eating while tightly controlling treatment expectation. N = 74 adults with overweight or obesity were informed of the known effects of tDCS to suppress craving and eating. Once electrodes were on the head, half of the participants were told they were receiving real, and the other half sham tDCS. Within these groups, approximately half actually received real and the other half sham tDCS. Stimulation parameters used were those previously found to reduce craving and eating, including in our lab: 2 mA, anode right/cathode left targeting the dorsolateral prefrontal cortex for 20 min (real), or only for the first and last minute (sham). Analyses controlled for demographics, hunger, trait impulsiveness, eating motives, dieting, binge eating, suggestibility, and baseline craving and eating. Participants told they were receiving real tDCS craved and ate less than participants told they were receiving sham tDCS (both p < 0.01), regardless of tDCS condition administered. There was no main effect of real vs. sham tDCS on craving or eating or an interaction between tDCS condition and expectation. The scientific validation of tDCS as a treatment for eating-related conditions hinges on controlling for the powerful effects of expectation. This can include the type of information provided on consent forms and participants' ability to guess real from sham conditions.",2019,There was no main effect of real vs. sham tDCS on craving or eating or an interaction between tDCS condition and expectation.,"['N\u202f=\u202f74 adults with overweight or obesity', 'individuals with overweight and obesity']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'transcranial direct current stimulation (tDCS']","['craving or eating', 'demographics, hunger, trait impulsiveness, eating motives, dieting, binge eating, suggestibility, and baseline craving and eating']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0233423', 'cui_str': 'Suggestibility, function (observable entity)'}]",74.0,0.0492521,There was no main effect of real vs. sham tDCS on craving or eating or an interaction between tDCS condition and expectation.,"[{'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Sylvester', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Helton', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Bethany R', 'Initials': 'BR', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Wagstaff', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tommy R', 'Initials': 'TR', 'LastName': 'McRae', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Turan', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Fontaine', 'Affiliation': 'Department of Health Behavior, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Franklin R', 'Initials': 'FR', 'LastName': 'Amthor', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Boggiano', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: boggiano@uab.edu.'}]",Appetite,['10.1016/j.appet.2018.12.044'] 1785,31068298,[Postoperative low-dose sufentanil combined with transversus abdominis plane block promotes recovery following laparoscopic hysterectomy].,"OBJECTIVE To compare the efficacy and safety of postoperative analgesia with low-dose sufentanil combined with transversus abdominis plane (TAP) block and with sufentanil alone in promoting patients'recovery following laparoscopic hysterectomy. METHODS Sixty patients undergoing laparoscopic hysterectomy in our hospital between September, 2016 and August, 2017 were randomly allocated into two equal groups. In group A, the patients were given postoperative analgesia with 1 μg/kg sufentanil, 9.96 mg tropisetronmesylate, and 200 mg flurbiprofen axetil (diluted with 0.9% NaCl solution to 100 mL, pumped at the rate of 2 mL/h) combined with TAP block; in group B, the patients received similar postoperative analgesia but at a higher dose of sufentanil (2 μg/kg) without TAP block. Visual analogue scale (VAS) was used to evaluate pain at 15 min and at 4, 8, 12, 24 and 48 h postoperatively, and the first off-bed time, the length of postoperative hospital stay and the incidence of postoperative nausea and vomiting (PONV) were recorded in all the patients. RESULTS Compared with those in group B, the patients in group A had significantly lower VAS scores at 15 min, 4 h, 8 h, and 12 h postoperatively ( P < 0.01) with also statistically shorter first off-bed time and postoperative hospital stay ( P < 0.01). Two (6.7%) patients in group A had mild PONV, and 6 (20.0%) in group B had PONV (including 4 with mild and 2 with moderate PONV). CONCLUSIONS Lowdose sufentanil combined with TAP block is effective for postoperative analgesia after laparoscopic hysterectomy and helps to reduce the incidence of PONV and shorten the first off-bed time and postoperative hospital stay to promote the recovery of the patients.",2019,"Compared with those in group B, the patients in group A had significantly lower VAS scores at 15 min, 4 h, 8 h, and 12 h postoperatively ( P < 0.01) with also statistically shorter first off-bed time and postoperative hospital stay ( P < 0.01).","['Sixty patients undergoing laparoscopic hysterectomy in our hospital between September, 2016 and August, 2017', 'laparoscopic hysterectomy']","['sufentanil (2 μg/kg) without TAP block', 'postoperative analgesia with low-dose sufentanil combined with transversus abdominis plane (TAP) block and with sufentanil alone', 'sufentanil combined with TAP block', 'postoperative analgesia with 1 μg/kg sufentanil, 9.96 mg tropisetronmesylate', 'sufentanil combined with transversus abdominis plane block', 'flurbiprofen axetil (diluted with 0.9% NaCl solution to 100 mL, pumped at the rate of 2 mL/h) combined with TAP block']","['postoperative hospital stay', 'mild PONV', 'PONV', 'Visual analogue scale (VAS', 'length of postoperative hospital stay and the incidence of postoperative nausea and vomiting (PONV', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0846266,"Compared with those in group B, the patients in group A had significantly lower VAS scores at 15 min, 4 h, 8 h, and 12 h postoperatively ( P < 0.01) with also statistically shorter first off-bed time and postoperative hospital stay ( P < 0.01).","[{'ForeName': 'Xuexia', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Guobin', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2019.03.17'] 1786,31416897,Heterogeneity of Treatment Effects From an Intensive Lifestyle Weight Loss Intervention on Cardiovascular Events in Patients With Type 2 Diabetes: Data From the Look AHEAD Trial.,"OBJECTIVE To explore the presence of heterogeneity of treatment effect (HTE) of an intensive lifestyle intervention on the occurrence of major cardiovascular events (MACE) in overweight or obese patients with type 2 diabetes, and to identify patient characteristics associated with individual treatment effect. RESEARCH DESIGN AND METHODS In 4,901 participants from the Action for Health in Diabetes (Look AHEAD) trial, a penalized Cox regression model to predict treatment effect of intensive lifestyle intervention for the risk of MACE was derived, including all possible treatment-by-covariate interaction terms. The ability of the model to predict HTE was confirmed by calculating hazard ratios (HRs) and absolute risk change in quartiles of predicted treatment effect, and baseline patient characteristics were compared between quartiles. RESULTS In quartile 1 of predicted treatment effect, with the highest predicted risk reduction, there was a significant treatment benefit of intensive lifestyle intervention (HR 0.64 [95% CI 0.49-0.83]), whereas there was no effect from treatment in quartiles 2 and 3 (HR 0.81 [95% CI 0.58-1.14] and 1.13 [95% CI 0.80-1.60], respectively) and a detrimental effect in quartile 4 (HR 1.37 [95% CI 1.09-1.73]). Several patient characteristics in demographics, medical history, physical examination, and laboratory values were associated with the level of treatment effect. CONCLUSIONS This post hoc analysis of the Look AHEAD trial showed that an intensive lifestyle intervention aimed at weight loss may reduce cardiovascular events in selected patients but may have a detrimental treatment effect in others.",2019,,['Patients With Type 2 Diabetes'],['Intensive Lifestyle Weight Loss Intervention'],['Cardiovascular Events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.172102,,"[{'ForeName': 'Tamar I', 'Initials': 'TI', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jannick A N', 'Initials': 'JAN', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'van der Graaf', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Frank L J', 'Initials': 'FLJ', 'LastName': 'Visseren', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands j.westerink-3@umcutrecht.nl.'}]",Diabetes care,['10.2337/dc19-0776'] 1787,9673660,Dissociation of mnemonic and perceptual processes during spatial and nonspatial working memory using fMRI.,"Neuroimaging studies in humans have consistently found robust activation of frontal, parietal, and temporal regions during working memory tasks. Whether these activations represent functional networks segregated by perceptual domain is still at issue. Two functional magnetic resonance imaging experiments were conducted, both of which used multiple-cycle, alternating task designs. Experiment 1 compared spatial and object working memory tasks to identify cortical regions differentially activated by these perceptual domains. Experiment 2 compared working memory and perceptual control tasks within each of the spatial and object domains to determine whether the regions identified in experiment 1 were driven primarily by the perceptual or mnemonic demands of the tasks, and to identify common brain regions activated by working memory in both perceptual domains. Domain-specific activation occurred in the inferior parietal cortex for spatial tasks, and in the inferior occipitotemporal cortex for object tasks, particularly in the left hemisphere. However, neither area was strongly influenced by task demands, being nearly equally activated by the working memory and perceptual control tasks. In contrast, activation of the dorsolateral prefrontal cortex and the intraparietal sulcus (IPS) was strongly task-related. Spatial working memory primarily activated the right middle frontal gyrus (MFG) and the IPS. Object working memory activated the MFG bilaterally, the left inferior frontal gyrus, and the IPS, particularly in the left hemisphere. Finally, activation of midline posterior regions, including the cingulate gyrus, occurred at the offset of the working memory tasks, particularly the shape task. These results support a prominent role of the prefrontal and parietal cortices in working memory, and indicate that spatial and object working memory tasks recruit differential hemispheric networks. The results also affirm the distinction between spatial and object perceptual processing in dorsal and ventral visual pathways.",1998,"Domain-specific activation occurred in the inferior parietal cortex for spatial tasks, and in the inferior occipitotemporal cortex for object tasks, particularly in the left hemisphere.",[],[],"['activation of the dorsolateral prefrontal cortex and the intraparietal sulcus (IPS', 'spatial and object perceptual processing in dorsal and ventral visual pathways']",[],[],"[{'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0228213', 'cui_str': 'Intraparietal Sulcus'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0042829', 'cui_str': 'Visual Pathways'}]",,0.0162686,"Domain-specific activation occurred in the inferior parietal cortex for spatial tasks, and in the inferior occipitotemporal cortex for object tasks, particularly in the left hemisphere.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Belger', 'Affiliation': 'Cognitive Neuroscience Laboratory, VA Medical Center, West Haven, Connecticut 06516, USA. Belger@npl.med.yale.edu'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Puce', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gore', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Goldman-Rakic', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McCarthy', 'Affiliation': ''}]",Human brain mapping,[] 1788,9673663,Robot-aided functional imaging: application to a motor learning study.,"The purpose of this study was to examine the neural activity underlying an implicit motor learning task. In particular, our goals were to determine whether initial phases of procedural learning of a motor task involve areas of the brain distinct from those involved in later phases of learning the task, and what changes in neural activity coincide with performance improvement. We describe a novel integration of robotic technology with functional brain imaging and its use in this study of implicit motor learning. A portable robotic device was used to generate forces that disturbed the subjects' arm movements, thereby generating a ""virtual mechanical environment"" that the subjects learned to manipulate. Positron emission tomography (PET) was used to measure indices of neural activity underlying learning of the motor task. Eight health, right-handed male subjects participated in the study. Results support the hypothesis that different stages of implicit learning (early and late implicit learning) occur in an orderly fashion, and that distinct neural structures may be involved in these different stages. In particular, neuroimaging results indicate that the cortico-striatal loop may play a significant role during early learning, and that the cortico-cerebellar loop may play a significant role during late learning.",1998,"A portable robotic device was used to generate forces that disturbed the subjects' arm movements, thereby generating a ""virtual mechanical environment"" that the subjects learned to manipulate.","['Eight health, right-handed male subjects participated in the study']","['Robot-aided functional imaging', 'implicit motor learning task', 'Positron emission tomography (PET']",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",[],,0.0175386,"A portable robotic device was used to generate forces that disturbed the subjects' arm movements, thereby generating a ""virtual mechanical environment"" that the subjects learned to manipulate.","[{'ForeName': 'H I', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Department of Ocean Engineering, MIT, Cambridge, Massachusetts 02139, USA. hikrebs@mit.edu'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Brashers-Krug', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Rauch', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Savage', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hogan', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Fischman', 'Affiliation': ''}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Alpert', 'Affiliation': ''}]",Human brain mapping,[] 1789,9659302,Does 'healing' benefit patients with chronic symptoms? A quasi-randomized trial in general practice.,"This study was designed to examine the effects of a healer seeing chronically ill patients in a large semirural practice. The 57 patients were allocated alternately either to receive ten weekly healing sessions or to become waiting-list controls. Two weeks after completion of 'healing' 22 (81%) of the 27 study patients thought their symptoms had improved and 15 of these thought they had improved substantially. Study patients scored better than controls on both measures of symptoms (P < 0.05, P < 0.01), on anxiety and depression ratings (P < 0.01, P < 0.05) and on general function measured by the Nottingham Health Profile (P < 0.01). Treatment differences were still evident three months later for one of the measures of symptom change (P < 0.05) and for both anxiety and depression ratings (P < 0.01, P < 0.05). The percentages of natural killer cells (CD16, CD56) did not change greatly in either group. These results suggest that healing may be an effective adjunct for the treatment of chronically ill patients presenting in general practice. They do not distinguish between any specific effects of spiritual healing and non-specific effects such as relaxation; for further investigation, randomized controlled trials will be needed.",1998,"Study patients scored better than controls on both measures of symptoms (P < 0.05, P < 0.01), on anxiety and depression ratings (P < 0.01, P < 0.05) and on general function measured by the Nottingham Health Profile (P < 0.01).","['57 patients', 'healer seeing chronically ill patients in a large semirural practice', 'chronically ill patients presenting in general practice']",['healing sessions or to become waiting-list controls'],"['percentages of natural killer cells (CD16, CD56', 'anxiety and depression ratings', 'symptom change', 'general function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",57.0,0.0193925,"Study patients scored better than controls on both measures of symptoms (P < 0.05, P < 0.01), on anxiety and depression ratings (P < 0.01, P < 0.05) and on general function measured by the Nottingham Health Profile (P < 0.01).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dixon', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1790,31415787,A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial.,"OBJECTIVE The aim of this split-mouth, triple-blind, randomized clinical trial was to evaluate the long-term clinical efficacy of experimental potassium oxalate concentration (10%) in relieving dentin hypersensitivity (DH), after a four-session application protocol. METHODS Potassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design. The desensitizers were applied following a four-session protocol, one session every 48 h. The primary outcome was the assessment of pain level with the visual analog scale (VAS, 0-10), at baseline, immediately after each desensitizing session, and also after the seventh day and along 1-,3-, 6-, 9- and 12-months follow-ups. Statistical analyses were performed using Friedman repeated measures and Wilcoxon signed rank tests (α = 0.05). RESULTS For both groups, the minimum of three sessions were required for the achievement of lower DH levels. Regardless of the concentration, the desensitizing effect was maintained all the way to the end of the 6-month follow-up. The 10%-potassium oxalate group was more effective for both 9 and 12-months follow-up periods (p < 0.001). No complications and adverse effects were observed. CONCLUSIONS When a four-session protocol is applied, both concentrations of potassium oxalate (5 and 10%) proved to be effective on DH reduction for up to six months. However, the higher concentration promoted better long-term results. CLINICAL SIGNIFICANCE The DH is an increasing condition in clinical practice, which affects the patient's life quality. This study provides primary clinical evidence, suggesting that multiple application sessions and higher concentrations of potassium oxalate may result in maintenance of the desensitizing effect for more extended periods. Trial registered under number: ClinicalTrials.gov NCT03083496.",2019,"No complications and adverse effects were observed. ","['dentin hypersensitivity reduction', 'Potassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design']",[],"['relieving dentin hypersensitivity (DH', 'DH reduction', 'assessment of pain level with the visual analog scale (VAS, 0-10', 'complications and adverse effects']","[{'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032837', 'cui_str': 'Potassium Oxalate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}]",[],"[{'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.188804,"No complications and adverse effects were observed. ","[{'ForeName': 'Alexia da Mata', 'Initials': 'ADM', 'LastName': 'Galvão', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: alexiamgalvao@gmail.com.'}, {'ForeName': 'Livia Fávaro', 'Initials': 'LF', 'LastName': 'Zeola', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: liviazeola@gmail.com.'}, {'ForeName': 'Guilherme Faria', 'Initials': 'GF', 'LastName': 'Moura', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: guifamo@gmail.com.'}, {'ForeName': 'Daniela Navarro Ribeiro', 'Initials': 'DNR', 'LastName': 'Teixeira', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: dnrteixeira@gmail.com.'}, {'ForeName': 'Ramon Corrêa de Queiroz', 'Initials': 'RCQ', 'LastName': 'Gonzaga', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: ramonfoufu@gmail.com.'}, {'ForeName': 'Gisele Rodrigues', 'Initials': 'GR', 'LastName': 'da Silva', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: giselerosilva@yahoo.com.br.'}, {'ForeName': 'Paulo Vinícius', 'Initials': 'PV', 'LastName': 'Soares', 'Affiliation': 'Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil. Electronic address: paulovsoares@yahoo.com.br.'}]",Journal of dentistry,['10.1016/j.jdent.2019.103180'] 1791,31436165,The Elusive Path Toward Measuring Health Outcomes: Lessons Learned From a Pseudo-Randomized Controlled Trial of a Large-Scale Mobile Health Initiative.,"Mobile health (mHealth) offers new opportunities to improve access to health services and health information. It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors. The availability of data from a multitude of sources (paper-based and electronic) provides the conditions to facilitate making stronger connections between self-reported data and clinical outcomes. This commentary shares lessons and important considerations based on the experience of applying new research frameworks and incorporating maternal and child health records data into a pseudo-randomized controlled trial to evaluate the impact of mMitra, a stage-based voice messaging program to improve maternal, newborn, and child health outcomes in urban slums in India.",2019,"It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors.",['urban slums in India'],[],['Health Outcomes'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0516516,"It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Washington, DC, United States.'}, {'ForeName': 'Nadi Nina', 'Initials': 'NN', 'LastName': 'Kaonga', 'Affiliation': 'All of Us Research Program, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Chandrasekharan', 'Affiliation': 'All of Us Research Program, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Muthu Perumal', 'Initials': 'MP', 'LastName': 'Prakash', 'Affiliation': 'Foundation for Research in Health Systems, Chennai, India.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Johnson & Johnson, Cape Town, South Africa.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Ganju', 'Affiliation': 'Saati Health, Mumbai, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Murthy', 'Affiliation': 'Foundation for Research in Health Systems, Bengaluru, India.'}]",JMIR mHealth and uHealth,['10.2196/14668'] 1792,31246132,Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis.,"BACKGROUND Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache. METHODS Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2-4 to 0 for ACT2. RESULTS The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype ( p  < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p  < 0.01). Only four patients discontinued the studies due to adverse events. CONCLUSIONS nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. TRIAL REGISTRATION The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).",2019,nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p  < 0.01).,"['episodic and chronic cluster headache', '225 participants (episodic: n\u2009=\u2009112; chronic: n\u2009=\u2009113) from ACT1 (n\u2009=\u2009133) and ACT2 (n\u2009=\u200992) in the nVNS (n\u2009=\u2009108) and sham (n\u2009=\u2009117) groups']","['sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS', 'non-invasive vagus nerve stimulation']","['chronic cluster headache', 'pain intensity']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",225.0,0.234538,nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p  < 0.01).,"[{'ForeName': 'Ilse F', 'Initials': 'IF', 'LastName': 'de Coo', 'Affiliation': '1 Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Juana Ca', 'Initials': 'JC', 'LastName': 'Marin', 'Affiliation': ""2 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': '3 Department of Neurology, Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': '4 Department of Neurology, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': '5 Migraine and Headache Clinic, Königstein, Germany.'}, {'ForeName': 'Candace K', 'Initials': 'CK', 'LastName': 'McClure', 'Affiliation': '6 North American Science Associates Inc., Minneapolis, MN, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': '7 Neurology Department, The Southern Hospital, Glasgow, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Liebler', 'Affiliation': '8 electroCore, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': '9 Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Ferrari', 'Affiliation': '1 Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""2 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419856607'] 1793,31930119,Impact of Health-Promoting Lifestyle Education Intervention on Health-Promoting Behaviors and Health Status of Postmenopausal Women: A Quasi-Experimental Study from Sri Lanka.,"Health promotion through lifestyle education is an important measure to enhance health status of postmenopausal women (PMW). This study evaluated the effectiveness of health-promoting lifestyle education intervention (HPLEI) on adhering to health-promoting behaviors (HPB) and enhancing the health status in a group of Sri Lankan PMW. A quasi-experimental study was conducted with randomly selected, sociodemographic status matched, 72 PMW from two geographically separated areas in Galle District, Sri Lanka, allocated as experimental ( n  = 37, 54.6 ± 4.5 years) and control ( n  = 35, 56.5 ± 3.4 years) groups. Education intervention focused on postmenopausal health management including lifestyle modifications was performed only for the experimental group during 8 weeks, and a health education package was provided. The control group was not given any planned education programme. Both groups were followed up for a 6-month period. HPB and menopausal symptoms severity were evaluated by validated Health Promoting Lifestyle Profile-II and Menopause Rating Scale, respectively. Anthropometric adiposity indices (AAIs) including weight, body mass index (BMI), waist (WC) and hip (HC) circumferences, and waist to hip ratio (WHR); cardiovascular disease risk indicators (CVDRI) including systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood sugar (FBS), total cholesterol and triglycerides, muscle strength; hand grip strength (HGS) and physical performance (PP); gait speed (GS) were measured. All parameters were evaluated before the intervention (baseline) and after follow-up of 6 months. All evaluated parameters were not different between experimental and control groups ( p > 0.05) at the baseline. In the follow-up evaluation, HPB ( p < 0.001), menopausal symptom scores ( p < 0.001), AAI ( p < 0.001), CVDRI (SBP, DBP, and FBS) ( p < 0.05) and HGS and GS ( p < 0.001) were significantly improved in the experimental group but not in the control group. Health education intervention focused on health-promoting lifestyle modifications is effective in improving the adherence to HPB and enhances the health status in PMW. This provides positive impact in lifestyle medicine.",2019,"In the follow-up evaluation, HPB ( p < 0.001), menopausal symptom scores ( p < 0.001), AAI ( p < 0.001), CVDRI (SBP, DBP, and FBS) ( p < 0.05) and HGS and GS ( p < 0.001) were significantly improved in the experimental group but not in the control group.","['A quasi-experimental study was conducted with randomly selected, sociodemographic status matched, 72 PMW from two geographically separated areas in Galle District, Sri Lanka, allocated as experimental ( n \u2009=\u200937, 54.6\u2009±\u20094.5 years) and control ( n \u2009=\u200935, 56.5\u2009±\u20093.4 years) groups', 'Postmenopausal Women', 'postmenopausal women (PMW']","['health-promoting lifestyle education intervention (HPLEI', 'Health education intervention', 'Health-Promoting Lifestyle Education Intervention', 'Education intervention']","['Anthropometric adiposity indices (AAIs) including weight, body mass index (BMI), waist (WC) and hip (HC) circumferences, and waist to hip ratio (WHR); cardiovascular disease risk indicators (CVDRI) including systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood sugar (FBS), total cholesterol and triglycerides, muscle strength; hand grip strength (HGS) and physical performance (PP); gait speed (GS', 'validated Health Promoting Lifestyle Profile-II and Menopause Rating Scale', 'CVDRI (SBP, DBP, and FBS', 'HGS and GS', 'HPB and menopausal symptoms severity', 'AAI', 'menopausal symptom scores', 'Health-Promoting Behaviors and Health Status']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038088', 'cui_str': 'Ceylon'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0018701'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C2607857'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.0148967,"In the follow-up evaluation, HPB ( p < 0.001), menopausal symptom scores ( p < 0.001), AAI ( p < 0.001), CVDRI (SBP, DBP, and FBS) ( p < 0.05) and HGS and GS ( p < 0.001) were significantly improved in the experimental group but not in the control group.","[{'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rathnayake', 'Affiliation': 'Department of Nursing, Faculty of Allied Health Sciences, Matara, University of Ruhuna, Sri Lanka.'}, {'ForeName': 'Gayani', 'Initials': 'G', 'LastName': 'Alwis', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, University of Ruhuna, Matara, Sri Lanka.'}, {'ForeName': 'Janaka', 'Initials': 'J', 'LastName': 'Lenora', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Ruhuna, Matara, Sri Lanka.'}, {'ForeName': 'Sarath', 'Initials': 'S', 'LastName': 'Lekamwasam', 'Affiliation': 'Population Health Research Centre, Department of Medicine, Faculty of Medicine, University of Ruhuna, Matara, Sri Lanka.'}]",BioMed research international,['10.1155/2019/4060426'] 1794,31427850,Long-Term Outcome of a Brief Intervention to Address Adolescent Drug Abuse in a School Setting.,"The present study used data from a randomized controlled trial on brief interventions with adolescents to identify distinct longitudinal patterns of substance use and identify predictors, as well as outcomes associated with those use patterns. Data were originally collected for the purpose of evaluating two brief intervention conditions with adolescents who had been identified in a school setting as abusing alcohol or other drugs (total sample, N = 315). Adolescents were randomly assigned to a two-session adolescent only brief intervention (BI-A), a two-session adolescent- plus an additional parent session (BI-AP), or an assessment only control session (CON). We located 74 participants to assess them at approximately 3.5 years post-intervention. Three distinct cluster patterns were identified, including a low decreasing, moderate increasing, and high decreasing pattern of use. The low decreasing cluster was associated with the BI-A condition, mono-substance use, and comorbid anxiety symptoms at baseline. The moderate increasing cluster was associated with the BI-AP condition, polysubstance use, and comorbid conduct disorder symptoms at baseline. No variables were found to be predictive of membership within the high decreasing cluster. There were also no differences found between clusters on adjustment outcomes in young adulthood. Overall findings from this study support the long-term efficacy of a brief intervention, without parent involvement, for adolescents experiencing mild to moderate substance abuse problems. Findings also highlight the importance of early intervention and the tailoring of interventions to meet the unique needs of adolescents.",2019,There were also no differences found between clusters on adjustment outcomes in young adulthood.,"['adolescents experiencing mild to moderate substance abuse problems', '74 participants to assess them at approximately 3.5 years post-intervention', 'adolescents who had been identified in a school setting as abusing alcohol or other drugs (total sample, N = 315', 'Adolescents', 'Adolescent Drug Abuse in a School Setting']","['two-session adolescent only brief intervention (BI-A), a two-session adolescent- plus an additional parent session (BI-AP), or an assessment only control session (CON', 'Brief Intervention']","['BI-A condition, mono-substance use, and comorbid anxiety symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",74.0,0.0209805,There were also no differences found between clusters on adjustment outcomes in young adulthood.,"[{'ForeName': 'Behin', 'Initials': 'B', 'LastName': 'Abedi', 'Affiliation': 'Argosy University Twin Cities College of Psychology and Behavioral Sciences, Eagan, MN, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Reardon', 'Affiliation': 'Argosy University Twin Cities College of Psychology and Behavioral Sciences, Eagan, MN, USA.'}, {'ForeName': 'Ken C', 'Initials': 'KC', 'LastName': 'Winters', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Journal of child & adolescent substance abuse,['10.1080/1067828X.2019.1623146'] 1795,31437295,Impact of Repetitive Text Messages on Retention of Knowledge.,"BACKGROUND Because of frequent changes in health care, nursing requires lifelong learning. Information learned in nursing school is not enough. To deliver quality patient care throughout their career, nurses need to keep up with these changes. METHOD This quantitative study explored using repetitive text messaging to improve retention of information to help nurses keep up with the perpetual changes in nursing. Participants attended a class, took an examination, and then were placed randomly in either a control or an experimental group. The experimental group received text messages with key details from the class, whereas the control group did not receive text messages. Participants took the examination again and group pretest-posttest scores were compared. RESULTS The experimental group showed statistically significant improvement in the final examination scores, whereas the control group showed no significant difference. CONCLUSION The results demonstrated that repetitive text messaging can be used to enhance retention of information. [J Contin Educ Nurs. 2019;50(9):399-403.].",2019,"The experimental group showed statistically significant improvement in the final examination scores, whereas the control group showed no significant difference. ",[],"['repetitive text messaging', 'Repetitive Text Messages', 'text messages with key details from the class, whereas the control group did not receive text messages']","['final examination scores', 'Retention of Knowledge']",[],"[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.018354,"The experimental group showed statistically significant improvement in the final examination scores, whereas the control group showed no significant difference. ","[{'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bowling', 'Affiliation': ''}]",Journal of continuing education in nursing,['10.3928/00220124-20190814-05'] 1796,31437124,Aromatherapy reduces fatigue among women with hypothyroidism: A randomized placebo-controlled clinical trial.,"Background This randomized, blinded, placebo-controlled clinical trial identifies the effect of an aromatherapy blend of essential oils on fatigue, which is one of the most commonly unaddressed symptoms of hypothyroidism, by evaluating the effects of daily aromatherapy inhalation. Methods Participants included women aged 18-55 with a diagnosis of hypothyroidism. Women who had a history of thyroid cancer were excluded, due to the confounding effects of cancer on fatigue as the outcome of interest. Participants were randomized into two groups: the aromatherapy group, treated with inhalation of the essential oil blend, and the control group, treated with an odorless vegetable oil blend. The primary outcome was change from baseline in fatigue scores as measured by the Multidimensional Fatigue Symptom Inventory (MFSI), a validated instrument which measures multiple patterns of fatigue. Results After adjusting for baseline scores, no significant difference was found between the aromatherapy group and the control group at midpoint. Both groups experienced a reduction in symptoms during the first week of the intervention. At the endpoint, participants in the aromatherapy group had improved fatigue scores across all ten subscales, as compared to the control group. Not all improvements achieved statistical significance, indicating that the aromatherapy treatment has a greater effect on the subscales of global, affective, and general fatigue. Conclusions This is the first study to evaluate the effects of aromatherapy on fatigue among women with hypothyroidism. These findings provide evidence that regular inhalation of an aromatherapy blend may reduce fatigue among women with hypothyroidism, particularly in the areas of global, affective, and general fatigue.",2019,"At the endpoint, participants in the aromatherapy group had improved fatigue scores across all ten subscales, as compared to the control group.","['Methods Participants included women aged 18-55 with a diagnosis of hypothyroidism', 'Women who had a history of thyroid cancer', 'women with hypothyroidism']","['aromatherapy blend of essential oils', 'aromatherapy', 'placebo', 'aromatherapy group, treated with inhalation of the essential oil blend, and the control group, treated with an odorless vegetable oil blend', 'Aromatherapy']","['fatigue', 'Multidimensional Fatigue Symptom Inventory (MFSI), a validated instrument which measures multiple patterns of fatigue', 'change from baseline in fatigue scores', 'fatigue scores', 'subscales of global, affective, and general fatigue']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}]","[{'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.106045,"At the endpoint, participants in the aromatherapy group had improved fatigue scores across all ten subscales, as compared to the control group.","[{'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Hawkins', 'Affiliation': 'Franklin School of Integrative Health Sciences, Aromatherapy, 504 Autumn Springs Ct ste 6, 37067 Franklin, United States of America.'}, {'ForeName': 'Christy Y', 'Initials': 'CY', 'LastName': 'Hires', 'Affiliation': 'Franklin School of Integrative Health Sciences, Aromatherapy, 504 Autumn Springs Ct ste 6, 37067 Franklin, United States of America.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Dunne', 'Affiliation': 'Franklin School of Integrative Health Sciences, University of Alabama in Birmingham, 504 Autumn Springs Ct ste 6, 37067 Franklin, United States of America.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Keenan', 'Affiliation': 'Middle Tennessee State University, 1301 E Main Street, Murfreesboro, TN37132, USA.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2018-0229'] 1797,31434508,Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial.,"BACKGROUND SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. METHODS Between November 2016 and April 2018, we recruited 97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5% to 10.0%, known coronary artery disease, and estimated glomerular filtration rate ≥60mL/min/1.73m 2 . The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). RESULTS Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m 2 , LV mass indexed to body surface area 60.7 [11.9] g/m 2 ), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35 g/m 2 ; 95% CI, -5.9 to -0.81g/m 2 , P =0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference -6.8mmHg, 95% CI -11.2 to -2.3mmHg, P =0.003), diastolic blood pressure (adjusted difference -3.2mmHg; 95% CI, -5.8 to -0.6mmHg, P =0.02) and elevation of hematocrit ( P =0.0003). CONCLUSIONS Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02998970.",2019,"Mean LVMi regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35","['97 participants (90 men [93%], mean [SD] age 62.8 [9.0] years, T2DM duration 11.0 [8.2] years, eGFR 88.4', 'people with T2DM and coronary artery disease (CAD', '97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5 to 10.0%, known CAD and estimated glomerular filtration rate (eGFR) ≥60mL/min/1.73m 2 ', 'Patients with Type 2 Diabetes and Coronary Artery Disease', 'type 2 diabetes (T2DM', 'Between November 2016 and April 2018']","['empagliflozin', 'Sodium-glucose co-transporter 2', 'placebo', 'Empagliflozin']","['left ventricular (LV) mass', 'LVMi', 'diastolic blood pressure', 'elevation of hematocrit', '6-month change in LV mass indexed (LVMi) to body surface area (BSA', 'overall ambulatory systolic blood pressure', '6-month changes in LV end-diastolic and -systolic volumes indexed to BSA (LVEDVi and LVESVi), ejection fraction (LVEF), 24-h ambulatory blood pressure, hematocrit and N-terminal pro b-type natriuretic peptide (NT-proBNP', 'Mean LVMi regression', 'Left Ventricular Mass']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]",97.0,0.492749,"Mean LVMi regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia (C.D.M.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tamique', 'Initials': 'T', 'LastName': 'Mason', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Garg', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Hwee', 'Initials': 'H', 'LastName': 'Teoh', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quan', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Department of Medicine (A.T.Y., V.G., M.E.F., D.H.F., S.G.G., R.E.G., L.A.L., P.J., B.Z., K.A.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Goldenberg', 'Affiliation': 'LMC Diabetes & Endocrinology, Concord, Ontario, Canada (R.M.G.).'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omran', 'Affiliation': ""Division of Vascular Surgery (M.A.O.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Gilbert', 'Affiliation': ""Division of Endocrinology and Metabolism (H.T., R.E.G., L.A.L.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Division of Endocrinology and Metabolism (H.T., R.E.G., L.A.L.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine (A.T.Y., V.G., M.E.F., D.H.F., S.G.G., R.E.G., L.A.L., P.J., B.Z., K.A.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042375'] 1798,31434111,A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome.,"BACKGROUND In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS). METHODS In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat. RESULTS A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group (0.443 [standard deviation, SD, 0.32] to 0.287 [SD, 0.20]) compared to placebo (0.426 [SD, 0.34] to 0.340 [SD, 0.39]); p  = 0.043. CONCLUSIONS Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.",2019,"CONCLUSIONS Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo.","['Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included', 'Women with Premenstrual Syndrome', 'Forty-three women in the active medicine group and 53 in the', 'A total of 105 women were included: 49', 'In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ', 'women with premenstrual syndrome (PMS']","['homeopathic medicines', 'Individualized Homeopathic Treatment', 'active medicine and 56 to placebo', 'placebo', 'Placebo', 'homeopathic prescription', 'active medicine or placebo']","['PM scores', 'mean daily premenstrual symptom (PM) scores', 'mean PM scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232959', 'cui_str': 'Symptom occurs premenstrually (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232959', 'cui_str': 'Symptom occurs premenstrually (finding)'}]",43.0,0.738947,"CONCLUSIONS Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Yakir', 'Affiliation': 'Israeli Association for Classical Homeopathy, Tel Aviv, Israel.'}, {'ForeName': 'Christien T', 'Initials': 'CT', 'LastName': 'Klein-Laansma', 'Affiliation': 'Louis Bolk Institute, Health and Nutrition, Bunnik, The Netherlands.'}, {'ForeName': 'Shulamith', 'Initials': 'S', 'LastName': 'Kreitler', 'Affiliation': 'Psycho-oncology Research Center, Sheba Medical Center, Tel HaShomer, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Brzezinski', 'Affiliation': 'Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Menachem', 'Initials': 'M', 'LastName': 'Oberbaum', 'Affiliation': 'The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Vithoulkas', 'Affiliation': 'International Homeopathic Academy, Allonisos, Greece.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Bentwich', 'Affiliation': 'Rosetta Genomics, Rehovot, Israel.'}]",Homeopathy : the journal of the Faculty of Homeopathy,['10.1055/s-0039-1691834'] 1799,23761529,Adoption of the double dummy trial design to reduce observer bias in testing treatments.,,2013,,[],[],[],[],[],[],,0.396094,,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Marušić', 'Affiliation': 'Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Stella Fatović', 'Initials': 'SF', 'LastName': 'Ferenčić', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,['10.1177/0141076813485350'] 1800,32011015,"Long-term clinical and radiographic results after treatment or no treatment of small buccal bone dehiscences at posterior dental implants: A randomized, controlled clinical trial.","AIM To test whether or not buccal vertical bone dehiscences (≤5 mm) around posterior implants left for spontaneous healing (SH) result in the same clinical and radiologic outcome as dehiscences treated with guided bone regeneration (GBR) at 7.5 years after implant placement (IMPL). MATERIALS AND METHODS Twenty-two patients receiving 28 posterior implants with a small non-contained buccal bone dehiscence (≤5 mm) were randomly assigned to the SH or the GBR group. Implants were loaded at 6 months. Clinical parameters (probing depths, sulcus bleeding index, plaque index) and approximal marginal radiographic bone levels were assessed regularly up to at least 6.8 years. The vertical extension of the dehiscences was measured clinically at IMPL and abutment connection and radiographically on cone beam computed tomographys at a mean follow-up time of 7.5 years. RESULTS Twenty patients with a total of 26 implants were recalled at 7.5 years (9.1% dropout). The implant/crown survival rates were 100% in both groups. Stable peri-implant tissues were observed in both groups showing only minimal signs of inflammation. During the entire study period (IMPL-7.5-year follow-up), the median buccal vertical bone gain measured 1.61 mm for the GBR group and 0.62 for the SH group showing no significant difference between the groups. Also, at 7.5 years, the median approximal marginal bone levels (GBR: 0.53; SH: 0.68) were not significantly different between the two groups (p = .61) while the remaining median buccal vertical dehiscences were larger in the SH group (2.51 mm) compared to the GBR group (1.66 mm; p = .02). CONCLUSIONS Implants with small non-contained buccal bone dehiscences exhibited high implant survival rates and healthy peri-implant tissues at 7.5 years. In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.",2020,"In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.","['small buccal bone dehiscences at posterior dental implants', '22 patients receiving 28 posterior implants with a small non-contained buccal bone dehiscence (≤5 mm', '20 patients with a total of 26 implants were recalled at 7.5 years (9.1% drop-out']","['guided bone regeneration (GBR', 'buccal vertical bone dehiscences (≤5 mm) around posterior implants left']","['buccal vertical bone levels', 'implant/crown survival rates', 'spontaneous healing (SH', 'median buccal vertical bone gain', 'implant survival rates', 'median buccal vertical dehiscences', 'median approximal marginal bone levels', 'Clinical parameters (PD, SBI, PI) and approximal marginal radiographic bone levels']","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",26.0,0.0310598,"In the GBR group, the buccal vertical bone levels were higher compared to the SH group but remained stable over the entire study period for both treatments.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Waller', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Herzog', 'Affiliation': 'Private Practice, Affoltern a.A., Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hüsler', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13588'] 1801,31433785,"Effects of treadmill training on the balance, functional capacity and quality of life in Parkinson's disease: A randomized clinical trial.","Background There is growing evidence that exercise modalities have considerable effects on Parkinson's disease (PD). This trial aimed to provide a more detailed viewpoint of short-term and long-term treadmill training (TT) effects on some motor and non-motor features of PD. Methods In this prospective, randomized, single-blind clinical trial, 20 mild to moderate PD patients, admitted in Rasoul-e-Akram hospital in Tehran, Iran, were randomly allocated in case (11) and control (9) groups. Treadmill intervention was performed at moderate intensity with 60% of heart rate reserved (HRR) in two 30-min sessions/week for a duration of 10 weeks. Both the groups were evaluated for three times; at the baseline, 2 months later and then 2 months after the second evaluation. We assigned the Timed Up and Go test (TUG), 6-min walk test (6MW), and the SF-8 healthy questionnaire, for assessment of balance, functional capacity, and Quality of life (QoL), respectively. Results Balance and functional capacity were significantly improved in the case group after the intervention (TUG p-value: 0.003, 6MW p-value: 0.003). Moreover, the long-term analysis revealed significant results as well (TUG p-value: 0.001, 6MW p-value: 0.004). Mental condition's scores of SF-8 in cases were not statistically different in short-term follow-up (F/U). However, analysis illustrated p-value: 0.016 for long-term assessment. The intervention induced significant changes in physical condition's scores in both of the F/Us (PC p-value: 0.013). Conclusions This study provides evidence that a TT of mild to moderate intensity has significant and persistent benefits for the balance, functional capacity, and QoL in PD.",2019,The intervention induced significant changes in physical condition's scores in both of the F/Us (PC p-value: 0.013).,"['20 mild to moderate PD patients, admitted in Rasoul-e-Akram hospital in Tehran, Iran', ""Parkinson's disease""]","['Treadmill intervention', 'treadmill training', 'short-term and long-term treadmill training (TT']","['Results Balance and functional capacity', ""physical condition's scores"", ""Mental condition's scores of SF-8"", 'balance, functional capacity and quality of life', 'Timed Up and Go test (TUG), 6-min walk test (6MW), and the SF-8 healthy questionnaire, for assessment of balance, functional capacity, and Quality of life (QoL']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0800348,The intervention induced significant changes in physical condition's scores in both of the F/Us (PC p-value: 0.013).,"[{'ForeName': 'Paria', 'Initials': 'P', 'LastName': 'Arfa-Fatollahkhani', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Safar Cherati', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Amir Hasan', 'Initials': 'SAH', 'LastName': 'Habibi', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholam Ali', 'Initials': 'GA', 'LastName': 'Shahidi', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sohrabi', 'Affiliation': 'Golestan University of Medical Sciences and Health Services, Gorgan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Zamani', 'Affiliation': 'Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2018-0245'] 1802,32438071,Baseline urinary metabolites predict albuminuria response to spironolactone in type 2 diabetes.,"The mineralocorticoid receptor antagonist spironolactone significantly reduces albuminuria in subjects with diabetic kidney disease, albeit with a large variability between individuals. Identifying novel biomarkers that predict response to therapy may help to tailor spironolactone therapy. We aimed to identify a set of metabolites for prediction of albuminuria response to spironolactone in subjects with type 2 diabetes. Systems biology molecular process analysis was performed a priori to identify metabolites linked to molecular disease processes and drug mechanism of action. Individual subject data and urine samples were used from 2 randomized placebo controlled double blind clinical trials (NCT01062763, NCT00381134). A urinary metabolite score was developed to predict albuminuria response to spironolactone therapy using penalized ridge regression with leave-one-out cross validation. Bioinformatic analysis identified a set of 18 metabolites linked to a diabetic kidney disease molecular model and potentially affected by spironolactone mechanism of action. Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively. In the test cohort, UACR reduction was higher in the lowest tertile of the baseline urinary metabolite score compared with middle and upper tertiles -58% (25th to 75% percentile -78 to 33), -28% (25th to 75% percentile -46 to 8), -40% (25th to 75% percentile -52% to 31), respectively, P = 0.001 for trend). In the replication cohort, UACR reduction was -54% (25th to 75% percentile -65 to -50), -41 (25th to 75% percentile -46% to 30), and -17% (25th to 75% percentile -36 to 5), respectively, P = 0.010 for trend). We identified a set of 18 urinary metabolites through systems biology to predict albuminuria response to spironolactone in type 2 diabetes. These data suggest that urinary metabolites may be used as a tool to tailor optimal therapy and move in the direction of personalized medicine.",2020,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","['subjects with diabetic kidney disease', 'type 2 diabetes', 'subjects with type 2 diabetes']","['spironolactone', 'mineralocorticoid receptor antagonist spironolactone', 'Spironolactone', 'spironolactone therapy', 'placebo']","['baseline urinary metabolite score', 'UACR reduction', 'albuminuria response', 'UACR relative']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0356557,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perco', 'Affiliation': 'Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Oxlund', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Uzma F', 'Initials': 'UF', 'LastName': 'Mehdi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Ib A', 'Initials': 'IA', 'LastName': 'Jacobsen', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: m.pena@umcg.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.04.010'] 1803,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens. METHODS Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar. RESULTS Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75). CONCLUSIONS Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75). ","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016'] 1804,32438041,"Corrigendum to ""Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial"" [Papillomavirus Res. 9 (2020) 100194].",,2020,"This difference remained significant after adjusting for covariates (age category, education level, time interval since last Pap smear, past Pap smear-taker). ","['cervical cancer screening', 'women who are currently not screened', 'Eighty-eight consenting women', 'Women aged 25-64 who did not have a Pap smear since three years and consulted a GP practice in a Flemish municipality between November, 2014 and April, 2015']",['vaginal self-sampling kit or control arm where women were encouraged to make an appointment for having a Pap smear taken by a clinician'],"['education level, time interval since last Pap smear, past Pap smear-taker']","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0376242', 'cui_str': 'Flemish language'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C1444637', 'cui_str': 'Past'}]",88.0,0.039767,"This difference remained significant after adjusting for covariates (age category, education level, time interval since last Pap smear, past Pap smear-taker). ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice, Oetingen, Gooik, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cammu', 'Affiliation': 'Department Uro-gynaecology, UZ Brussels, Brussels, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Primary and Interdisciplinary Care (ELIZA), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100201'] 1805,9014880,Educating psychiatric patients about their treatment: do fact sheets work?,"Psychiatric patients are sometimes given fact sheets about their treatment but the benefits of these are uncertain. We tested three strategies in three cohorts of psychiatric inpatients--fact sheets alone, fact sheets and subsequent discussion, and control. Knowledge of medication was assessed by questionnaire. For various reasons, only 33 of the 77 patients were included in the study or analysis. Of the patients who had been given fact sheets, 87% independently read them and reported finding them helpful whilst all asked for more information. Receiving a fact sheet alone had no significant effect, whereas having discussed it with a health care professional was associated with a significant increase in knowledge about medication. Patients receiving fact sheets selectively learned more about side-effects than about drug action or precautions. This strategy for patient education could be used by ward nurses and deserves further evaluation.",1996,"Receiving a fact sheet alone had no significant effect, whereas having discussed it with a health care professional was associated with a significant increase in knowledge about medication.","['Psychiatric patients', '33 of the 77 patients were included in the study or analysis']",[],['knowledge about medication'],"[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",77.0,0.0292045,"Receiving a fact sheet alone had no significant effect, whereas having discussed it with a health care professional was associated with a significant increase in knowledge about medication.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Department of Mental Health, University of Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Macpherson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Babiker', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1806,32437703,"Reactions to graphic and text health warnings for cigarettes, sugar-sweetened beverages, and alcohol: An online randomized experiment of US adults.","We aimed to examine reactions to graphic versus text-only warnings for cigarettes, SSBs, and alcohol. A convenience sample of US adults completed an online survey in 2018 (n = 1352 in the analytic sample). We randomly assigned participants to view a: 1) text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information. Participants viewed their assigned warning on cigarettes, SSBs, and alcohol, in a random order. Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ. Compared to SSB and alcohol warnings, cigarette warnings led to higher perceived message effectiveness, believability, fear, thinking about harms, policy support, and greater reductions in product appeal (all p < .05). The efficacy information did not influence any outcomes. Graphic warnings out-performed text-only warnings on key predictors of behavior despite causing more reactance.",2020,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","['A convenience sample of US adults completed an online survey in 2018 (n\u202f=\u202f1352 in the analytic sample', 'cigarettes, sugar-sweetened beverages, and alcohol', 'US adults']","[""text-only warning without efficacy information (i.e., message intended to increase consumers' confidence in their ability to stop using the product), 2) text-only warning with efficacy information, 3) graphic warning without efficacy information, or 4) graphic warning with efficacy information""]","['message effectiveness, believability, fear, thinking about harms, policy support', 'lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332288', 'cui_str': 'Without'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0359166,"Across product types, graphic warnings were perceived as more effective than text-only warnings (p < .001) and led to lower believability, greater reactance (i.e., resistance), more thinking about harms, and lower product appeal (all p < .05); policy support did not differ.","[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Population and Development Studies, Harvard TH Chan School of Public Health, Cambridge, MA, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK; MRC Integrative Epidemiology Unit (IEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA; Carolina Population Center, University of North Carolina, Chapel Hill, NC, USA; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106120'] 1807,31433573,The effect of olfactory training on odor identification in patients with traumatic anosmia.,"BACKGROUND This study investigates the effect of olfactory training on odor identification in patients with traumatic anosmia. METHODS Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection thresholds remained at -1 after steroid and zinc treatment, were included in this study between July 2016 and July 2018. They were randomly divided into 2 groups, with patients in the 4-odorant group given 4 bottles of PEA, lemon, eucalyptus, and clove oils and those in the PEA group given a bottle of PEA for 6-month olfactory training. After 3-month and 6-month training, the olfactory function was evaluated by both the PEA threshold test and the traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Magnetic resonance imaging was performed to measure the volume of olfactory bulbs after training. RESULTS There were 45 patients completing 4-odorant training and another 45 completing PEA training. The birhinal PEA threshold decreased significantly in both groups after 6-month training, but the decrease was not significantly different between the 2 groups. The UPSIT-TC score increased significantly in the PEA group but not in the 4-odorant group. The volume of olfactory bulbs was not significantly different between these 2 groups. CONCLUSION Our results show that olfactory training can slightly improve odor threshold levels in patients with traumatic anosmia, but did not improve the odor identification ability. Nevertheless, clinical improvement or benefit in quality of life from olfactory training needs further investigation.",2019,"The birhinal PEA threshold decreased significantly in both groups after 6-month training, but the decrease was not significantly different between the 2 groups.","['patients with traumatic anosmia', 'Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection thresholds remained at -1 after steroid and zinc treatment, were included in this study between July 2016 and July 2018', '45 patients completing 4-odorant training and another 45 completing PEA training']","['4-odorant group given 4 bottles of PEA, lemon, eucalyptus, and clove oils and those in the PEA group given a bottle of PEA for 6-month olfactory training', 'olfactory training', 'Magnetic resonance imaging', 'PEA']","['volume of olfactory bulbs', 'olfactory function', 'UPSIT-TC score', 'birhinal PEA threshold']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393780', 'cui_str': 'Traumatic anosmia'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0003126', 'cui_str': 'Anosmia'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0031398', 'cui_str': 'Phenylethyl Alcohol'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2985522', 'cui_str': 'Odorants'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030738', 'cui_str': 'Peas'}]","[{'cui': 'C2985522', 'cui_str': 'Odorants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0939864', 'cui_str': 'Lemon extract'}, {'cui': 'C0015148', 'cui_str': 'Eucalyptus'}, {'cui': 'C0028906', 'cui_str': 'Clove oil'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0028936', 'cui_str': 'Bulbus Olfactorius'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",,0.0174243,"The birhinal PEA threshold decreased significantly in both groups after 6-month training, but the decrease was not significantly different between the 2 groups.","[{'ForeName': 'Rong-San', 'Initials': 'RS', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chih-Wen', 'Initials': 'CW', 'LastName': 'Twu', 'Affiliation': 'Department of Otolaryngology, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Kai-Li', 'Initials': 'KL', 'LastName': 'Liang', 'Affiliation': 'Department of Otolaryngology, Taichung Veterans General Hospital, Taichung, Taiwan.'}]",International forum of allergy & rhinology,['10.1002/alr.22409'] 1808,31400634,Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.,"BACKGROUND Since 2015, adjuvant therapy with ipilimumab is an approved treatment for stage III melanoma based on a significantly prolonged recurrence-free survival (RFS). At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events. We present now long-term follow-up results of this European Organisation for Research and Treatment of Cancer 18071 trial. PATIENTS, METHODS AND RESULTS A total of 99 sites randomised 951 patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) with adequate resection of lymph nodes to receive intravenous infusions of ipilimumab 10 mg/kg or placebo, every 3 weeks for 4 doses, then every 3 months for up to 3 years. The RFS, DMFS and OS, as reported by the local investigators, were assessed by the intention-to-treat analysis. Among 431 patients randomised at 63 sites and who were still alive at the analysis reported in 2016, recent follow-up information could be obtained for 264 patients. The median OS follow-up was 6.9 years. The RFS (hazard ratio [HR] 0.75, 95% confidence interval 0.63-0.88; P < 0.001), DMFS (HR 0.76, 0.64-0.90; P = 0.002) and OS (HR 0.73, 0.60-0.89; P = 0.002) benefit observed in the ipilimumab group was durable with an 8.7% absolute difference at 7 years for OS. The benefit was consistent across subgroups. CONCLUSIONS Adjuvant therapy with ipilimumab prolongs RFS, DMFS and OS significantly. The benefit is sustained long term and consistent across subgroups.",2019,"At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events.","['431 patients randomised at 63 sites and who were still alive at the analysis reported in 2016, recent follow-up information could be obtained for 264 patients', 'after complete resection of stage III melanoma', 'A total of 99 sites randomised 951 patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1\xa0mm or in-transit metastasis) with adequate resection of lymph nodes to receive']","['intravenous infusions of ipilimumab 10\xa0mg/kg or placebo', 'placebo', 'ipilimumab', 'Adjuvant ipilimumab']","['RFS, distant metastasis-free survival (DMFS) and overall survival (OS', 'DMFS ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",951.0,0.692446,"At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events.","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Insitute and University Paris-Sud, France. Electronic address: alexander.eggermont@gustaveroussy.fr.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'AIX-Marseille University, Marseille, France.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University of Zurich Hospital, Zurich, Switzerland.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Melanoma Department, Gustave Roussy Institute and Univerity Paris-Sud, France.'}, {'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Richards', 'Affiliation': 'Oncology Specialists, SC, Park Ridge, IL, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbe', 'Affiliation': 'Dermatology and CIC Department, AP-HP, Saint-Louis Hospital, Université de Paris, INSERM U976, Paris, France.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'New York University Perlmutter Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'de Pril', 'Affiliation': ""Bristol-Myers Squibb, Braine-L'alleud, Belgium.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Formerly at European Institute of Oncology, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.001'] 1809,32437664,"First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial.","BACKGROUND Addition of trastuzumab to first-line chemotherapy improves overall survival in patients with HER2-positive metastatic gastric cancer. We assessed the safety and activity of pembrolizumab in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer. METHODS This study was an investigator-initiated, open-label, non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer. Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53%. Patients were eligible to receive an initial induction cycle of 200 mg flat dose of intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab. For subsequent cycles, patients received 130 mg/m 2 of intravenous oxaliplatin or 80 mg/m 2 of cisplatin on day 1, 850 mg/m 2 of oral capecitabine twice a day for 2 weeks followed by 1 week off (or intravenous 5-fluorouracil, 800 mg/m 2 per day on days 1-5), and a 200 mg flat dose of intravenous pembrolizumab, and 6 mg/kg of trastuzumab, administered on day 1 of each 3-week cycle. The primary endpoint was 6-month progression-free survival, defined as the proportion of patients alive and free of progression at 6 months, assessed in patients who received at least one dose of trastuzumab and pembrolizumab. The regimen would be considered worthy of further investigation if 26 or more of 37 patients were progression-free at 6 months. This trial is registered with ClinicalTrials.gov, NCT02954536, and is ongoing, but closed to enrolment. FINDINGS Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled. At the time of data cutoff on Aug 6, 2019, median follow-up among survivors was 13·0 months (IQR 11·7-23·5). The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. The most common treatment-related adverse event of any grade was neuropathy, which was reported in 36 (97%) of 37 patients. The most common grade 3 or 4 adverse events were lymphocytopenia (seven [19%] patients with grade 3 and two [5%] with grade 4), grade 3 decreased electrolytes (six [16%] patients), and grade 3 anaemia (four [11%] patients). Serious adverse events occurred in two patients patients (both grade 3 nephritis leading to treatment discontinuation). Four patients discontinued pembrolizumab because of immune-related adverse events. There were no treatment-related deaths. INTERPRETATION Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway. FUNDING Merck & Co.",2020,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"['HER2-positive metastatic oesophagogastric cancer', 'Eligible patients had measurable or evaluable non-measurable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and left ventricular ejection fraction of at least 53', 'patients aged 18 years or older with HER2-positive metastatic oesophagogastric cancer', 'first-line HER2-positive metastatic oesophagogastric cancer', 'HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer', 'Between Nov 11, 2016, and Jan 23, 2019, 37 patients were enrolled', 'first-line HER2-positive metastatic oesophagogastric (gastric, oesophageal, or gastroesophageal junction) cancer', 'patients with HER2-positive metastatic gastric cancer']","['oxaliplatin', 'intravenous pembrolizumab and 8 mg/kg loading dose of intravenous trastuzumab', 'trastuzumab and pembrolizumab', 'trastuzumab to first-line chemotherapy', 'trastuzumab and chemotherapy', 'capecitabine', 'cisplatin', 'pembrolizumab, and 6 mg/kg of trastuzumab', 'pembrolizumab versus placebo', 'First-line pembrolizumab and trastuzumab', '5-fluorouracil', 'pembrolizumab']","['safety and activity', '6-month progression-free survival, defined as the proportion of patients alive and free of progression', 'overall survival', 'grade 3 decreased electrolytes', 'grade 3 anaemia', 'efficacy and safety', 'Serious adverse events']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0740464', 'cui_str': 'Electrolytes NOS decreased'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",37.0,0.193351,The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months.,"[{'ForeName': 'Yelena Y', 'Initials': 'YY', 'LastName': 'Janjigian', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA. Electronic address: janjigiy@mskcc.org.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Maron', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Walid K', 'Initials': 'WK', 'LastName': 'Chatila', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Tri-Institutional Program in Computational Biology and Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Millang', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Shweta S', 'Initials': 'SS', 'LastName': 'Chavan', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Alterman', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Michal F', 'Initials': 'MF', 'LastName': 'Segal', 'Affiliation': 'Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marc Z', 'Initials': 'MZ', 'LastName': 'Simmons', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Momtaz', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Shcherba', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zervoudakis', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Won', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kelsen', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Ilson', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Nagy', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lanman', 'Affiliation': 'Guardant Health, Redwood City, CA, USA.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Ptashkin', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark T A', 'Initials': 'MTA', 'LastName': 'Donoghue', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Taylor', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Solit', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Schultz', 'Affiliation': 'Marie-Josée & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jaclyn F', 'Initials': 'JF', 'LastName': 'Hechtman', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30169-8'] 1810,8778430,Randomized comparison of oral and intravenous fluid regimens after gallbladder surgery.,"Numerous studies of post-operative fluid status have utilized sophisticated measurements of electrolyte distribution and fluid shift without relating results to clinical practice. The aim of this prospective randomized study was to investigate the response of patients undergoing abdominal surgery of moderate severity to conservative post-operative fluid administration. Forty-five patients undergoing open cholecystectomy were randomized to receive 2.51 of fluid (1 l normal saline and 1.51 5% dextrose), 1 l of normal saline, or free oral fluids (groups 1, 2, 3, respectively). Serum and urine osmolality and electrolytes were measured pre-operatively and at 24 and 48 h post-operatively. Patients remained in the study irrespective of the urine output. Plasma electrolytes and osmolality remained within normal limits in all three groups despite significant changes in urine electrolyte and osmolality in groups 2 and 3. This confirms that a conservative approach to fluid administration has no detrimental effect on hydration in fit patients with uncomplicated surgery.",1996,Plasma electrolytes and osmolality remained within normal limits in all three groups despite significant changes in urine electrolyte and osmolality in groups 2 and 3.,"['after gallbladder surgery', 'Forty-five patients undergoing open cholecystectomy', 'patients undergoing abdominal surgery of moderate severity to conservative post-operative fluid administration', 'patients with uncomplicated surgery']","['oral and intravenous fluid regimens', 'fluid (1 l normal saline and 1.51 5% dextrose), 1 l of normal saline, or free oral fluids']","['Serum and urine osmolality and electrolytes', 'Plasma electrolytes and osmolality', 'urine electrolyte and osmolality']","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine (procedure)'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0587362', 'cui_str': 'Electrolytes measurement, urine (procedure)'}]",45.0,0.132884,Plasma electrolytes and osmolality remained within normal limits in all three groups despite significant changes in urine electrolyte and osmolality in groups 2 and 3.,"[{'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Cassell', 'Affiliation': 'Department of Surgery, Royal Hallamshire Hospital, Sheffield, England.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Oakley', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Forrest', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Dennison', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1811,8683491,Evaluation of the effect of colloid (Haemaccel) on the bleeding time in the trauma patient.,,1996,,['trauma patient'],['colloid (Haemaccel'],['bleeding time'],"[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0918273', 'cui_str': 'Haemaccels'}]","[{'cui': 'C0005729', 'cui_str': 'Bleeding Time'}]",,0.0338671,,"[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Evans', 'Affiliation': 'Department of Accident and Emergency, Leicester Royal Infirmary, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Boffard', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kirkman', 'Affiliation': ''}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Jacobson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1812,8683517,How can acute mountain sickness be quantified at moderate altitude?,"Reports of acute mountain sickness (AMS) at moderate altitude show a wide variability, possibly because of different investigation methods. The aim of our study was to investigate the impact of investigation methods on AMS incidence. Hackett's established AMS score (a structured interview and physical examination), the new Lake Louise AMS score (a self-reported questionnaire) and oxygen saturation were determined in 99 alpinists after ascent to 2.94 km altitude. AMS incidence was 8% in Hackett's AMS score and 25% in the Lake Louise AMS score. Oxygen saturation correlated inversely with Hackett's AMS score with no significant correlation with the Lake Louise AMS score. At moderate altitude, the new Lake Louise AMS score overestimates AMS incidence considerably. Hackett's AMS score remains the gold standard for evaluating AMS incidence.",1996,Oxygen saturation correlated inversely with Hackett's AMS score with no significant correlation with the Lake Louise AMS score.,[],[],"[""Hackett's established AMS score"", 'AMS incidence', 'Oxygen saturation', 'new Lake Louise AMS score (a self-reported questionnaire) and oxygen saturation']",[],[],"[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",99.0,0.0157699,Oxygen saturation correlated inversely with Hackett's AMS score with no significant correlation with the Lake Louise AMS score.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roeggla', 'Affiliation': 'Department of Emergency Medicine, University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roeggla', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Podolsky', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Laggner', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1813,31238784,Can WeChat group-based intervention reduce reperfusion time in patients with ST-segment myocardial infarction? A controlled before and after study.,"BACKGROUND Pre-hospital identification of acute ST-elevation myocardial infarction and activation of the catheterization laboratory can reduce first medical contact to wire-crossing times. We conducted a study on providing 24-hour tele-electrocardiography services via the WeChat group application, aiming to reduce the time taken for diagnosis and treatment of ST-elevation myocardial infarction. METHODS A controlled before and after study was conducted on 140 ST-elevation myocardial infarction patients who were initially seen in non-percutaneous coronary intervention-capable hospital and transferred for primary percutaneous coronary intervention at our percutaneous coronary intervention centre from 1 February to 31 October 2018. The WeChat group had 70 patients with pre-hospital electrocardiography transmission via WeChat and the control group had 70 patients who did not transfer pre-hospital electrocardiography. The reperfusion time of the two groups was compared to evaluate the effect of the WeChat group intervention. RESULTS In the WeChat group versus the control group, the median symptom onset to first medical contact time was similar (129 vs 150 min, p  > 0.05), but the median first medical contact to wire, door to wire and first medical contact to catheterization laboratory activity were significantly shorter (132 vs 171 minutes, p  < 0.001; 60 vs 95 minutes, p  < 0.001; 29 vs 74 minutes, p  < 0.001, respectively). CONCLUSIONS Pre-hospital electrocardiography transfer via a WeChat group resulted in earlier reperfusion of ST-elevation myocardial infarction patients who were transferred from the non-percutaneous coronary intervention centre.",2019,,['patients with ST-segment myocardial infarction'],[],['reperfusion time'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],"[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0102293,,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Haojia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Shushuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856473'] 1814,8505747,The effectiveness of low dose slow release aspirin as an antiplatelet agent.,"An open, randomized, parallel group study of three different aspirin preparations was carried out. The objective of this study was to compare their ability to inhibit the production of thromboxane A2 (measured as thromboxane B2 [TXB2]) from platelets. Three aspirin preparations were studied: Acetard 300 mg, Acetard 100 mg and Platet 100 mg. The study was conducted in 45 healthy adult volunteers and treatment continued once daily for 7 days. The results of the TXB2 assay show that the administration of all three treatment preparations produced a rapid drop in TXB2 levels of all volunteers. The baseline TXB2 level was reduced by 95% for all groups by day 3. Analysis by day showed a significant difference (P < 0.05) between treatments at day 1, with Acetard 100 mg having higher TXB2 levels than the other two groups. Analysis of changes from baseline showed a significant reduction (P < 0.05) in TXB2 levels at Days 1 to 14 for all three groups. Platelet aggregation also showed a significant reduction, being reduced to 10% of control at 7 days. It then reverted back to baseline by 28 days for all treatment groups. In conclusion, low dose aspirin is very effective as an antiplatelet agent and in a slow release form loses none of its patency.",1993,"Analysis by day showed a significant difference (P < 0.05) between treatments at day 1, with Acetard 100 mg having higher TXB2 levels than the other two groups.",['45 healthy adult volunteers and treatment continued once daily for 7 days'],"['aspirin preparations', 'aspirin']","['baseline TXB2 level', 'Platelet aggregation', 'TXB2 levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0040059', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",45.0,0.0486386,"Analysis by day showed a significant difference (P < 0.05) between treatments at day 1, with Acetard 100 mg having higher TXB2 levels than the other two groups.","[{'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Budd', 'Affiliation': 'Department of Surgery, University of Leicester, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Bell', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1815,31801563,"A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol.","BACKGROUND Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa. METHODS/DESIGN The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5-12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019. DISCUSSION This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.",2019,"Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality.","['child mortality in Burkina Faso, West Africa', 'children attending primary healthcare facilities during the first 5-12\u2009weeks of life for a healthy child visit (e.g., for vaccination']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin distribution or placebo', 'azithromycin or placebo']","['cause mortality', 'under-5 all-cause mortality']","[{'cui': 'C0008083', 'cui_str': 'Child Mortality'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.55982,"Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Ouattara', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Bountogo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Cheik', 'Initials': 'C', 'LastName': 'Bagagnan', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Boudo', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Brogdon', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg, Germany.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3855-9'] 1816,31427205,"Individualised axitinib regimen for patients with metastatic renal cell carcinoma after treatment with checkpoint inhibitors: a multicentre, single-arm, phase 2 study.","BACKGROUND Checkpoint inhibitor therapy is a standard of care for patients with metastatic renal cell carcinoma. Treatment options after checkpoint inhibitor therapy include vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitors, although no prospective data regarding their use in this setting exist. Axitinib is a VEGF-R inhibitor with clinical data supporting increased activity with dose titration. We aimed to investigate the activity of dose titrated axitinib in patients with metastatic renal cell carcinoma who were previously treated with checkpoint inhibitor. METHODS We did a multicentre, phase 2 trial of axitinib given on an individualised dosing algorithm. Patients at least 18 years of age with histologically or cytologically confirmed locally recurrent or metastatic renal cell carcinoma with clear cell histology, a Karnofsky Performance Status of 70% or more, and measurable disease who received checkpoint inhibitor therapy as the most recent treatment were eligible. There was no limit on number of previous therapies received. Patients received oral axitinib at a starting dose of 5 mg twice daily with dose titration every 14 days in 1 mg increments (ie, 5 mg twice daily to 6 mg twice daily, up to 10 mg twice daily maximum dose) if there was no axitinib-related grade 2 or higher mucositis, diarrhoea, hand-foot syndrome, or fatigue. If one or more of these grade 2 adverse events occurred, axitinib was withheld for 3 days before the same dose was resumed. Dose reductions were made if recurrent grade 2 adverse events despite treatment breaks or grade 3-4 adverse events occurred. The primary outcome was progression-free survival. Analyses were done per protocol in all patients who received at least one dose of axitinib. Recruitment has been completed and the trial is ongoing. This trial is registered with ClincalTrials.gov, number NCT02579811. FINDINGS Between Jan 5, 2016 and Feb 21, 2018, 40 patients were enrolled and received at least one dose of study treatment. With a median follow-up of 8·7 months (IQR 3·7-14·2), the median progression-free survival was 8·8 months (95% CI 5·7-16·6). Fatigue (83%) and hypertension (75%) were the most common all-grade adverse events. The most common grade 3 adverse event was hypertension (24 patients [60%]). There was one (3%) grade 4 adverse event (elevated lipase) and no treatment-related deaths occurred. Serious adverse events that were likely related to therapy occurred in eight (20%) patients; the most common were dehydration (n=4) and diarrhoea (n=2). INTERPRETATION Individualised axitinib dosing in patients with metastatic renal cell inoma previously treated with checkpoint inhibitors did not meet the prespecified threshold for progression free survival, but these data show that this individualised titration scheme is feasible and has robust clinical activity. These prospective results warrant consideration of axitinib in this setting. FUNDING Pfizer.",2019,There was one (3%) grade 4 adverse event (elevated lipase) and no treatment-related deaths occurred.,"['Patients at least 18 years of age with histologically or cytologically confirmed locally recurrent or metastatic renal cell carcinoma with clear cell histology, a Karnofsky Performance Status of 70% or more, and measurable disease who received checkpoint inhibitor therapy as the most recent treatment were eligible', 'patients with metastatic renal cell carcinoma who were previously treated with checkpoint inhibitor', 'patients with metastatic renal cell inoma previously treated with', 'patients with metastatic renal cell carcinoma after treatment with', 'Between Jan 5, 2016 and Feb 21, 2018, 40 patients were enrolled and received at least one dose of study treatment', 'patients with metastatic renal cell carcinoma']","['Checkpoint inhibitor therapy', 'titrated axitinib', 'oral axitinib', 'Individualised axitinib regimen', 'axitinib', 'checkpoint inhibitors', 'checkpoint inhibitor therapy']","['progression-free survival', 'hypertension', 'median progression-free survival', 'Serious adverse events', 'grade 4 adverse event (elevated lipase', 'Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",40.0,0.103481,There was one (3%) grade 4 adverse event (elevated lipase) and no treatment-related deaths occurred.,"[{'ForeName': 'Moshe C', 'Initials': 'MC', 'LastName': 'Ornstein', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA. Electronic address: ornstem@ccf.org.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Wood', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Jackie M', 'Initials': 'JM', 'LastName': 'Tomer', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Xuefei S', 'Initials': 'XS', 'LastName': 'Jia', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Allman', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olencki', 'Affiliation': 'Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Davis', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Gilligan', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mortazavi', 'Affiliation': 'Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'W Kimryn', 'Initials': 'WK', 'LastName': 'Rathmell', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt Ingram Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic-Taussig Cancer Institute, Cleveland, OH, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30513-3'] 1817,32438600,Increasing Physical Activity in Empty Nest and Retired Populations Online: A Randomized Feasibility Trial Protocol.,"Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.",2020,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","['older adults', 'Empty Nest and Retired Populations Online', 'Participants are recruited by online and print flyers as well as in-person at community events']",[],"['recruitment, attrition, data collection, intervention delivery, and acceptability', 'risk of disease, mortality, falls, and cognitive and functional decline']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.103504,"The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cox', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, Department of Education, University of Victoria, Victoria, BC V8W 3N4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17103544'] 1818,32438192,MicroRNA expression in response to bisphenol A is associated with high blood pressure.,"Bisphenol A (BPA) is a ubiquitous environmental contaminant that is known to be associated with the risk of arterial hypertension. However, the underlying mechanisms describing how BPA exposure leads to high blood pressure (BP) and the role of epigenetics are still unclear. Therefore, we evaluated associations among BPA exposure, microRNA (miRNA) expression, and BP in a randomized crossover trial with 45 non-smoking females over 60 years of age. The participants visited the study site 3 times and were dose-dependently exposed to BPA. Two hours after exposure to BPA, urine and whole blood were collected for BPA measurement and miRNA profiling, and BP was measured. Relationships among urinary BPA level, miRNA expression, and BP were estimated using the mixed effect model. Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP. The core functional network from BPA exposure to increased BP was found to be on the pathway through these six miRNAs and their predicted BP-related target genes. Our results suggest that epigenetic biomarkers for BPA exposure and hypertension provide mechanistic data to explain hypertension exacerbation as well as key information for predicting the health effects of BPA exposure.",2020,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.",['45 non-smoking females over 60\xa0years of age'],['Bisphenol A (BPA'],"['urinary BPA level, miRNA expression, and BP', 'blood pressure (BP', 'BPA exposure, microRNA (miRNA) expression, and BP', 'BPA measurement and miRNA profiling, and BP']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}]","[{'cui': 'C0053800', 'cui_str': 'bisphenol A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",45.0,0.0257088,"Decreases in miR-30a-5p, miR-580-3p, miR-627-5p, and miR-671-3p and increases in miR-636 and miR-1224-3p attributable to BPA exposure were associated with high BP.","[{'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Integrative Bioscience & Biotechnology, Sejong University, Seoul 05006, Republic of Korea. Electronic address: jhkim777@sejong.ac.kr.'}, {'ForeName': 'Yoon Hee', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Department of Biomedical and Pharmaceutical Sciences, The University of Montana, Montana 59812-1552, USA. Electronic address: unicho3@gmail.com.'}, {'ForeName': 'Yun-Chul', 'Initials': 'YC', 'LastName': 'Hong', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, Seoul 110-799, Republic of Korea.'}]",Environment international,['10.1016/j.envint.2020.105791'] 1819,8410889,Complications following general anaesthesia for cataract surgery: a comparison of the laryngeal mask airway with tracheal intubation.,"The incidence of airway complications following general anaesthesia using either a tracheal tube or a laryngeal mask airway was compared in a prospective, randomized study of 79 patients undergoing elective cataract surgery using a standard anaesthetic technique. Assessment was made both at extubation (which was taken to include removal of the laryngeal mask airway) and for 25 min afterwards. There was a significantly greater incidence of coughing prior to extubation (P < 0.001), at extubation (P < 0.001) and after extubation (P < 0.001) in the tracheal group than in the laryngeal mask airway group. No other airway complications were seen in either group.",1993,"There was a significantly greater incidence of coughing prior to extubation (P < 0.001), at extubation (P < 0.001) and after extubation (P < 0.001) in the tracheal group than in the laryngeal mask airway group.","['79 patients undergoing', 'cataract surgery']","['general anaesthesia', 'elective cataract surgery using a standard anaesthetic technique', 'general anaesthesia using either a tracheal tube or a laryngeal mask airway', 'laryngeal mask airway with tracheal intubation']","['incidence of coughing prior to extubation', 'airway complications', 'Complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube (physical object)'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",79.0,0.0160013,"There was a significantly greater incidence of coughing prior to extubation (P < 0.001), at extubation (P < 0.001) and after extubation (P < 0.001) in the tracheal group than in the laryngeal mask airway group.","[{'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Denny', 'Affiliation': 'Department of Anaesthesia, Queen Elizabeth Hospital, Norfolk, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gadelrab', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1820,8371245,The effectiveness of suction drainage in total hip arthroplasty.,,1993,,['total hip arthroplasty'],['suction drainage'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}]",[],,0.0148524,,"[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Murphy', 'Affiliation': 'Westminster Hospital, London.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Scott', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1821,31417322,Blood pressure lowering effects of a novel isometric exercise device following a 4-week isometric handgrip intervention.,"Background: Hypertension is the leading risk factor for global mortality. Isometric resistance exercise training reduces blood pressure (BP). However, the protocols used are often limited by cost/immobility and the use of rigid exercise modalities. In response, a novel more versatile, isometric exercise (IE) device, the IsoBall (IB) was created. Purpose: The aim of this study was to test the BP-lowering effectiveness of this prototype. Methods: Twenty-three healthy participants (29.10±2.19 years old, 173.95±3.83 cm, 75.43±5.06 kg, SBP 127.10±10.37 mmHg, DBP 70.40±6.77 mmHg) were randomly allocated to either a control group (CON) or 2 isometric handgrip (IHG) training groups that used the Zona plus (ZON) and IB devices. The intervention groups completed 3 sessions each week of 4, 2 min IHG at 30% maximal voluntary contraction, with a 1-min rest, for 4 weeks. Resting BP, heart rate (HR) and IHG strength were measured in all groups at baseline and postintervention. Results: Postintervention systolic BP (SBP) was significantly lower in both ZON (114.5±8.2 mmHg, p  = 0.000) and IB (119.9±7.0 mmHg, p  = 0.000) compared to control (131.0±12.4 mmHg). Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg). Mean arterial pressure (MAP) was reduced in both groups (ZON 82.6±6.8 mmHg, p  = 0.000; IB 84.3±9.1 mmHg, p  = 0.000) compared to control (91.0±9.7 mmHg). No significant changes were seen in HR or strength ( p > 0.05). Conclusion: The results of this study indicate that both the ZON and IB devices elicit significant SBP, DBP and MAP reductions. Despite the ZON group having larger reductions in BP, no significant differences were found between the two devices. Thus, this study indicates the IB device to be an effective alternative to the ZON that can also be used to perform other IE modalities.",2019,"Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg).","['Methods: Twenty-three healthy participants (29.10±2.19 years old, 173.95±3.83 cm, 75.43±5.06 kg, SBP 127.10±10.37 mmHg, DBP 70.40±6.77']","['novel isometric exercise device', 'ZON', 'control group (CON) or 2 isometric handgrip (IHG) training groups that used the Zona plus (ZON) and IB devices', 'Isometric resistance exercise training']","['Mean arterial pressure (MAP', 'Postintervention systolic BP (SBP', 'HR or strength', 'SBP, DBP and MAP reductions', 'Resting BP, heart rate (HR) and IHG strength', 'Postintervention diastolic BP (DBP', 'blood pressure (BP']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",23.0,0.0242792,"Postintervention diastolic BP (DBP) was reduced in both intervention groups (ZON 66.6±7.4 mmHg, p  = 0.004; IB 65.7±10.0 mmHg, p  = 0.012) compared to CON (71.1±8.8 mmHg).","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Baddeley-White', 'Affiliation': 'Department of Life & Sport Sciences, University of Greenwich, Medway Campus, London, UK.'}, {'ForeName': 'Cheri L', 'Initials': 'CL', 'LastName': 'McGowan', 'Affiliation': 'Department of Kinesiology, Faculty of Human Kinetics, University of Windsor, Windsor, ON, Canada.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Howden', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte, Charlotte, NC, USA.'}, {'ForeName': 'Benjamin Dh', 'Initials': 'BD', 'LastName': 'Gordon', 'Affiliation': 'Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Slippery Rock, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kyberd', 'Affiliation': 'Department of Engineering Science, University of Greenwich, Medway Campus, London, UK.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Swaine', 'Affiliation': 'Department of Life & Sport Sciences, University of Greenwich, Medway Campus, London, UK.'}]",Open access journal of sports medicine,['10.2147/OAJSM.S193008'] 1822,7769597,Postoperative analgesia following total hip replacement: a comparison of intrathecal morphine and diamorphine.,"Sixty patients undergoing elective total hip replacement under spinal anaesthesia were randomly assigned to receive either intrathecal (IT) diamorphine 0.75 mg (n = 30) or IT morphine 1.0 mg (n = 30). Postoperative pain scores, analgesic requirements and side effects were assessed by a blinded observer. Postoperative pain scores were broadly similar and satisfactory for both groups but the amount of additional IV morphine required to achieve this was significantly reduced in the morphine compared with the diamorphine group (P < 0.05). Twelve of the morphine group required no postoperative analgesics compared with four in the diamorphine group (P < 0.02). There were no differences between the groups in the incidence of side effects such as emesis and pruritus. No significant postoperative respiratory depression was noted. In the doses used intrathecal morphine provided superior postoperative analgesia to that of intrathecal diamorphine.",1995,Twelve of the morphine group required no postoperative analgesics compared with four in the diamorphine group (P < 0.02).,"['Sixty patients undergoing elective total hip replacement under spinal anaesthesia', 'total hip replacement']","['intrathecal (IT) diamorphine', 'morphine', 'diamorphine', 'intrathecal morphine and diamorphine', 'intrathecal diamorphine', 'intrathecal morphine', 'IT morphine']","['Postoperative pain scores, analgesic requirements and side effects', 'postoperative respiratory depression', 'Postoperative analgesia', 'incidence of side effects such as emesis and pruritus', 'postoperative analgesics', 'Postoperative pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}]",60.0,0.0533815,Twelve of the morphine group required no postoperative analgesics compared with four in the diamorphine group (P < 0.02).,"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Fogarty', 'Affiliation': ''}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Milligan', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1823,31422028,Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.,"BACKGROUND Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival. METHODS We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab. FINDINGS Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52 (0·37-0·71) for nivolumab and 0·80 (0·61-1·04) for docetaxel. Long-term data did not show any new safety signals. INTERPRETATION Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage. FUNDING Bristol-Myers Squibb.",2019,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","['patients with previously treated advanced non-small-cell lung cancer (NSCLC', 'patients from the phase 3 CheckMate 017 and 057 studies', 'patients who did not have a radiographic tumour assessment at 6 months', 'patients with previously treated advanced non-small-cell lung cancer', 'patients who received at least one dose of nivolumab', 'patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003', 'Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included']","['docetaxel', 'nivolumab versus docetaxel', 'nivolumab or docetaxel', 'nivolumab']","['survival outcomes', 'duration of response', '4-year overall survival with nivolumab', '4-year overall survival', 'Survival subsequent to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}]",664.0,0.50406,"Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0·18 (95% 0·12-0·27) for nivolumab and 0·43 (0·29-0·65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0·52","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA. Electronic address: scott.antonia@duke.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Castro Carpeño', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pluzanski', 'Affiliation': 'Klinika Nowotworow Pluca i Klatki Piersiowej, Centrum Onkologii-Instytut Im Marii Sklodowskiej-Curie, Warsaw, Poland.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Burgio', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garassino', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, CT, USA.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Crinò', 'Affiliation': 'Medical Oncology Unit, Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori (IRST) IRCSS, Meldola, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Butts', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wojcik-Tomaszewska', 'Affiliation': 'Wojewodzkie Centrum Onkologii, Gdańsk, Poland.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Otterson', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Penrod', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brahmer', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30407-3'] 1824,32438639,"Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial.","Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments. We investigated whether the consumption of Concord grape juice (CGJ), rich in anti-inflammatory flavonoids, would be tolerated and safe in individuals with GWI and explored improvement in cognitive function and fatigue. Thirty-six veterans with GWI enrolled in a 24-week randomized, double-blind, Phase I/IIA clinical trial to explore safety, tolerability, and feasibility of 16 ounces daily of commercially available CGJ compared to placebo. Participants completed neurocognitive tests and self-reported surveys at baseline, 12 and 24 weeks. Thirty-one participants (86%) completed the study; no dropouts were related to side effects. Thirty participants (83%) documented ≥80% adherence. There were no statistically significant unadjusted differences between CGJ and placebo groups in change in efficacy measures from baseline to endpoint. We employed general linear regression models controlling for baseline differences between groups which indicated statistically significant improvement in the Halstead Category Test-Russell Revised Version (RCAT) at endpoint in the CGJ group compared to placebo (8.4 points, p = 0.04). Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p = 0.67). CGJ was safe and well-tolerated by veterans with GWI. Our data suggest high tolerability and potential benefit from CGJ in veterans with GWI and can be used to inform future studies of efficacy.",2020,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p = 0.67).","['Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990-1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments', 'Thirty-six veterans with GWI enrolled', 'Gulf War Veterans with Gulf War Illness', 'veterans with GWI']","['CGJ', 'Placebo', 'Dietary Supplementation with Concord Grape Juice', 'consumption of Concord grape juice (CGJ', 'placebo']","['Safety, Tolerability and Efficacy', 'cognitive functioning', 'safe and well-tolerated', 'tolerated and safe', 'Halstead Category Test-Russell Revised Version (RCAT']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C4224777', 'cui_str': 'Concord grape juice'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4505444', 'cui_str': 'Halstead Category Test'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.431748,"Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses ( p -values: 0.09-0.32), nor did the fatigue variable ( p = 0.67).","[{'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Helmer', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Van Doren', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Litke', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Chin-Lin', 'Initials': 'CL', 'LastName': 'Tseng', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Lap', 'Initials': 'L', 'LastName': 'Ho', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}, {'ForeName': 'Omowunmi', 'Initials': 'O', 'LastName': 'Osinubi', 'Affiliation': 'War Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.'}, {'ForeName': 'Giulio Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17103546'] 1825,7884770,Wound drains in proximal femoral fracture surgery: a randomized prospective trial of 177 patients.,We report on the effect of wound drains on wound healing following surgery for proximal femoral fractures. One hundred and seventy-seven patients undergoing AO dynamic hip screw (DHS) or hemiarthroplasty were randomized whether or not to receive wound drainage. Patients who received wound drainage showed statistically better wound healing in terms of the ASEPSIS wound scoring system and a reduced infection rate. This study conflicts with previous smaller studies which failed to show an effect of wound drainage upon wound healing.,1995,Patients who received wound drainage showed statistically better wound healing in terms of the ASEPSIS wound scoring system and a reduced infection rate.,"['surgery for proximal femoral fractures', '177 patients', 'One hundred and seventy-seven patients undergoing AO dynamic hip screw (DHS) or hemiarthroplasty', 'proximal femoral fracture surgery']","['wound drains', 'Wound drains', 'wound drainage']","['wound healing', 'infection rate']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015802', 'cui_str': 'Femoral Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0180503', 'cui_str': 'Wound drain (physical object)'}, {'cui': 'C0920263', 'cui_str': 'Wound drainage'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",177.0,0.0618305,Patients who received wound drainage showed statistically better wound healing in terms of the ASEPSIS wound scoring system and a reduced infection rate.,"[{'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Varley', 'Affiliation': 'Royal Air force Hospital, Wroughton, Near Swindon, Wiltshire, UK.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Milner', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1826,31429912,Comparing Web-Based and Classroom-Based Memory Training for Older Adults: The ACTIVE Memory Works™ Study.,"OBJECTIVES To compare the efficacy of a web-based versus a classroom-based memory training program in enhancing cognition and everyday functioning in older adults, and program satisfaction and acceptability. METHOD Participants (N = 208; mean age = 71.1) were randomly assigned to a web-based or classroom-based training, or to a wait-list control condition. Cognitive and everyday functioning measures were administered at baseline, immediate, and 6 months post-training; both training groups evaluated program satisfaction and acceptability at immediate post-training. Repeated-measures analyses of variance assessed training effects on cognitive and functioning outcomes; independent-samples t tests assessed group differences in program satisfaction and acceptability. RESULTS Compared to controls, neither training group showed a significant improvement on measures of memory or everyday functioning as assessed by dependence or difficulty on instrumental activities of daily living over time. Training effects did not transfer to non-trained cognitive abilities. The web-based group was as satisfied with the training as the classroom-based group (p > .05). DISCUSSION Although no significant training effects were found, we demonstrated that a web-based platform is an acceptable and feasible mode to provide memory training to healthy older adults. Further studies are needed to investigate the potential of web-based memory training programs for improving cognition and function in cognitively healthy older adults.",2020,"The web-based group was as satisfied with the training as the classroom-based group (p>.05). ","['healthy older adults', 'Older Adults', 'older adults', 'Participants (N=208', 'cognitively healthy older adults']","['web-based versus a classroom-based memory training program', 'web-based or classroom-based training, or to a wait-list control condition', 'Web-based and Classroom-based Memory Training']","['transfer to non-trained cognitive abilities', 'Cognitive and everyday functioning measures', 'instrumental activities of daily living over time', 'program satisfaction and acceptability', 'measures of memory or everyday functioning']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0183112,"The web-based group was as satisfied with the training as the classroom-based group (p>.05). ","[{'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Tzuang', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'Parisi', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz107'] 1827,31427204,"Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.","BACKGROUND In the ongoing phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma, with a manageable safety profile. In this study, we aimed to assess efficacy and safety after extended follow-up to inform the long-term clinical benefit of nivolumab plus ipilimumab versus sunitinib in this setting. METHODS In the phase 3, randomised, controlled CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to open-label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, followed by nivolumab (3 mg/kg intravenously) every 2 weeks; or sunitinib (50 mg orally) once daily for 4 weeks (6-week cycle). Randomisation was done through an interactive voice response system, with a block size of four and stratified by risk status and geographical region. The co-primary endpoints for the trial were overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients. Secondary endpoints were overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events in all treated patients. In this Article, we report overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety after extended follow-up. Efficacy outcomes were assessed in all randomly assigned patients; safety was assessed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but now closed to recruitment. FINDINGS Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-treat population; 425 vs 422 intermediate-risk or poor-risk patients, and 125 vs 124 favourable-risk patients). With extended follow-up (median follow-up 32·4 months [IQR 13·4-36·3]), in intermediate-risk or poor-risk patients, results for the three co-primary efficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in terms of overall survival (median not reached [95% CI 35·6-not estimable] vs 26·6 months [22·1-33·4]; hazard ratio [HR] 0·66 [95% CI 0·54-0·80], p<0·0001), progression-free survival (median 8·2 months [95% CI 6·9-10·0] vs 8·3 months [7·0-8·8]; HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001). Similarly, in intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with sunitinib in terms of overall survival (median not reached [95% CI not estimable] vs 37·9 months [32·2-not estimable]; HR 0·71 [95% CI 0·59-0·86], p=0·0003), progression-free survival (median 9·7 months [95% CI 8·1-11·1] vs 9·7 months [8·3-11·1]; HR 0·85 [95% CI 0·73-0·98], p=0·027), and the proportion of patients achieving an objective response (227 [41%] of 550 vs 186 [34%] of 546 p=0·015). In all treated patients, the most common grade 3-4 treatment-related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547), increased amylase (31 [6%]), and increased alanine aminotransferase (28 [5%]), whereas in the sunitinib group they were hypertension (90 [17%] of 535), fatigue (51 [10%]), and palmar-plantar erythrodysaesthesia (49 [9%]). Eight deaths in the nivolumab plus ipilimumab group and four deaths in the sunitinib group were reported as treatment-related. INTERPRETATION The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories. FUNDING Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","['patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to', 'advanced renal cell carcinoma', 'patients with previously untreated advanced renal cell carcinoma across all risk categories', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients', 'patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma']","['nivolumab plus ipilimumab or sunitinib', 'Nivolumab plus ipilimumab versus sunitinib', 'open-label nivolumab (3 mg/kg intravenously) plus ipilimumab', 'sunitinib', 'nivolumab plus ipilimumab']","['Efficacy outcomes', 'fatigue', 'alanine aminotransferase', 'overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients', 'overall survival', 'adverse events', 'increased amylase', 'progression-free survival', 'overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events', 'progression-free survival ', 'efficacy', 'efficacy and safety', 'hypertension', 'palmar-plantar erythrodysaesthesia', 'proportion of patients achieving an objective response', 'overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",1390.0,0.285576,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology and Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Department of Medical Oncology, Centro de Invetigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Beuselinck', 'Affiliation': 'Department of Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare, Charlotte, NC, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Department of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel; Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, IstitutoToscanoTumori, Arezzo, Italy.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': 'Oncology Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sjoukje F', 'Initials': 'SF', 'LastName': 'Oosting', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redman', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Department of Cancer Services: Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Service de Cancérologie Médicale Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pook', 'Affiliation': 'Department of Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30413-9'] 1828,8459374,Postoperative nausea and vomiting: a comparison of anti-emetic drugs used alone or in combination.,"Drugs with anti-emetic properties can exert their actions at more than one receptor site, histamine H1, muscarinic cholinergic or dopaminergic D2 receptors. This study was designed to test the hypothesis that a combination of drugs acting at different receptor sites in lower than standard doses would be at least as effective as a standard therapeutic dose of a single anti-emetic agent. A combination of droperidol, hyoscine and metoclopramide in subtherapeutic doses has been shown to be at least as effective as droperidol (1.25 mg) alone. In both groups there was a low incidence of emetic sequelae in the first 3 hours postoperatively.",1993,In both groups there was a low incidence of emetic sequelae in the first 3 hours postoperatively.,[],"['droperidol', 'droperidol, hyoscine and metoclopramide']","['emetic sequelae', 'Postoperative nausea and vomiting']",[],"[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0013973', 'cui_str': 'Emetic Agents'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",,0.0162606,In both groups there was a low incidence of emetic sequelae in the first 3 hours postoperatively.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Michaloudis', 'Affiliation': 'Department of Anaesthesia, Withington Hospital, Manchester.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': ""O'Keeffe"", 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': ''}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Healy', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1829,31376781,Fostering adolescent curiosity through a question brainstorming intervention.,"INTRODUCTION High adolescent curiosity is associated with several positive outcomes, yet questioning, a common behavioral manifestation of curiosity, declines once children enter formal schooling. The present quasi-experimental study empirically investigated whether directly teaching students to question helps to foster students' more enduring, dispositional tendency towards curiosity. METHOD The study explored the impact of a direct-instruction student-brainstorming intervention, the Question Formulation Technique (QFT), on adolescents' curiosity. The study's sample included adolescents (N = 3173) in four public high schools in the United States nested within 43 educators' English/Language Arts classrooms. Teachers (N = 43) were randomly assigned to two groups, one of which received professional development in the QFT in fall 2015 and the other in the winter of 2016. The study utilized student self-report questionnaires and teacher fidelity checks at three time points (fall, winter, and spring) to consider the impact of the QFT on participating adolescents' curiosity. RESULTS Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth. CONCLUSIONS The study suggests that adolescent dispositional curiosity can be significantly increased by directly teaching students to question.",2019,"RESULTS Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth. ","['Teachers (N\u202f=\u202f43', ""adolescents' curiosity"", ""study's sample included adolescents (N\u202f=\u202f3173) in four public high schools in the United States nested within 43 educators' English/Language Arts classrooms""]","['direct-instruction student-brainstorming intervention, the Question Formulation Technique (QFT', 'professional development in the QFT', 'QFT']",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0010472', 'cui_str': 'Curiosity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0023010', 'cui_str': 'Language Arts'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0243107', 'cui_str': 'development'}]",[],,0.029311,"RESULTS Multilevel modeling results indicated a positive treatment effect of the QFT on adolescents' curiosity, a positive adherence effect on adolescents' curiosity growth, and a positive dosage effect on adolescents' curiosity growth. ","[{'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Harvard University, United States. Electronic address: shelby_clark@gse.harvard.edu.'}, {'ForeName': 'Allen G', 'Initials': 'AG', 'LastName': 'Harbaugh', 'Affiliation': 'Boston University, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Seider', 'Affiliation': 'Boston College, United States.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.07.007'] 1830,31801584,"Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial.","BACKGROUND Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Ethiopia in 2016 reported doing so at a health facility. Maternity waiting homes (MWHs) have been introduced to overcome geographical and financial barriers to institutional births but there is no conclusive evidence as to their effectiveness. We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. METHODS A parallel, three-arm, stratified, cluster-randomized controlled trial design is being employed to evaluate intervention effects on institutional births, which is the primary outcome. Trial arms are: (1) upgraded MWH + religious/community leader training; (2) leader training alone; and (3) standard care. Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round. Outcome assessments will be made using repeat cross-sectional surveys at baseline and 24 months postintervention. An intention to treat approach will be used and the primary outcome analysed using generalized linear mixed models with a random effect for cluster and time. A cost-effectiveness analysis will also be conducted from a societal perspective. DISCUSSION This is one of the first trials to evaluate the effectiveness of upgraded MWHs and will provide much needed evidence to policy makers about aspects of functionality and the community engagement required as they scale-up this programme in Ethiopia. TRIAL REGISTRATION ClinicalTrial.gov, NCT03299491. Retrospectively registered on 3 October 2017.",2019,"We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. ","['institutional births among women in the Jimma zone, Ethiopia', 'institutional births in the Jimma zone of Ethiopia', 'Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round', 'Maternity waiting homes (MWHs']","['upgraded maternity waiting homes and local leader training', 'upgraded MWH\u2009+\u2009religious/community leader training; (2) leader training alone; and (3) standard care', 'upgraded MWHs and local leader training']",['maternal mortality'],"[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0419373', 'cui_str': 'Livebirth (finding)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0024923', 'cui_str': 'Maternal Mortality'}]",24.0,0.265289,"We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. ","[{'ForeName': 'Jaameeta', 'Initials': 'J', 'LastName': 'Kurji', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, K1G 5Z3, Canada. jkurj022@uottawa.ca.'}, {'ForeName': 'Manisha A', 'Initials': 'MA', 'LastName': 'Kulkarni', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, K1G 5Z3, Canada.'}, {'ForeName': 'Lakew Abebe', 'Initials': 'LA', 'LastName': 'Gebretsadik', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Muluemebet Abera', 'Initials': 'MA', 'LastName': 'Wordofa', 'Affiliation': 'Department of Population & Family Health, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Morankar', 'Affiliation': 'Department of Health, Behaviour & Society, Jimma University, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kunuz Haji', 'Initials': 'KH', 'LastName': 'Bedru', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Gebeyehu', 'Initials': 'G', 'LastName': 'Bulcha', 'Affiliation': 'Jimma Zone Health Office, Jimma Town, Jimma Zone, Ethiopia.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ontario Hospital Research Institute, The Ottawa Hospital - General Campus, Ottawa, ON, Canada.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Labonte', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, ON, K1G 5Z3, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ontario Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Ave, Civic Box 693, Admin Services Building, ASB 2-004, Ottawa, ON, K1Y 4E9, Canada.'}]",Trials,['10.1186/s13063-019-3755-z'] 1831,31801593,Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial.,"BACKGROUND Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis being the primary manifestation during the remission stage. Patients often have a slow course and long history of the disease. The refractory type of psoriasis is a stubborn rash that does not subside easily. We designed this randomized controlled trial to compare the effectiveness and relapse rates of plaque psoriasis in patients treated with either acupuncture, moxibustion or calcipotriol ointment. The ultimate aim of the study is to select an effective traditional Chinese medicine therapy for patients with plaque psoriasis. METHODS The study will be a multicenter, prospective, randomized controlled trial that compares the effectiveness of fire needle therapy, moxibustion and calcipotriol ointment. In total, 160 patients with plaque psoriasis who meet the inclusion criteria will be recruited from three hospitals in Beijing and then randomly assigned to receive either fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment (group B). All participants will receive an 8-week treatment and will then be followed up for another 24 weeks, with time points at weeks 12 and 24 after treatment completion. The primary outcomes to be measured are relapse rates and psoriasis area and severity index score of the target lesions. In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured. Adverse events will be recorded for safety assessment. DISCUSSION The aim of this study is to determine whether fire needle therapy or moxibustion could improve the clinical effectiveness for psoriasis lesions and reduce the relapse rate. Once completed, it will provide information regarding therapeutic evaluation on fire needle therapy or moxibustion for plaque psoriasis, which will assist clinicians in selecting the most effective treatment options for patients. TRIAL REGISTRATION International Clinical Trials Registry Platform (ICTRP), ChiCTR1800019588. Registered on 19 November 2018.",2019,"In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured.","['160 patients with plaque psoriasis who meet the inclusion criteria will be recruited from three hospitals in Beijing', 'Patients often have a slow course and long history of the disease', 'patients with plaque psoriasis', 'patients treated with either', 'chronic plaque psoriasis']","['Fire needle acupuncture or moxibustion', 'fire needle therapy or moxibustion', 'fire needle therapy, moxibustion and calcipotriol ointment', 'acupuncture, moxibustion or calcipotriol ointment', 'Chinese medicine therapy', 'fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment']","['relapse rates and psoriasis area and severity index score of the target lesions', 'target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion', 'relapse rate']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",160.0,0.143199,"In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured.","[{'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Haibing', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': 'Gulou Hospital of Traditional Chinese Medicine of Beijing, Beijing, 100009, China.'}, {'ForeName': 'Xingwu', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Bohua', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Di', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Jinchao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China. fengshuo_1988@126.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China. liping411@126.com.'}]",Trials,['10.1186/s13063-019-3736-2'] 1832,31801597,"Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.","BACKGROUND Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy (PPV) under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery. METHODS Ninety-six patients will be randomly assigned to either the control group, in whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. DISCUSSION This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy. TRIAL REGISTRATION Clinical Trials Register EudraCT, 2018-000753-45. Registered on 11 November 2018.",2019,"BACKGROUND Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy.","['Ninety-six patients', 'anticoagulated patients', 'patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery']","['oral anticoagulant therapy before pars plana vitrectomy (PPV', 'vitreoretinal surgery with and without oral anticoagulants', 'subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy', 'oral anticoagulant therapy']","['perioperative thromboembolic events', 'haemorrhagic complications']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",96.0,0.15619,"BACKGROUND Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy.","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Andonegui', 'Affiliation': 'Department of Ophthalmology, Complejo Hospitalario de Navarra, 31007, Pamplona, Spain. jandonen@cfnavarra.es.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Zubicoa', 'Affiliation': 'Department of Ophthalmology, Complejo Hospitalario de Navarra, 31007, Pamplona, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}]",Trials,['10.1186/s13063-019-3805-6'] 1833,31046521,"Sildenafil enhances central hemodynamic responses to exercise, but not V̇o 2peak , in people with diabetes mellitus.","Exercise capacity is frequently reduced in people with diabetes mellitus (DM), and the contribution of pulmonary microvascular dysfunction remains undefined. We hypothesized that pulmonary microvascular disease, measured by a novel exercise echocardiography technique termed pulmonary transit of agitated contrast (PTAC), would be greater in subjects with DM and that the use of pulmonary vasodilator agent sildenafil would improve exercise performance by reducing right ventricular afterload. Forty subjects with DM and 20 matched controls performed cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion in a double-blind randomized crossover design. The primary efficacy end point was exercise capacity (V̇o 2peak ) while secondary measures included pulmonary vascular resistance, cardiac output, and change in PTAC. DM subjects were aged 44 ± 13 yr, 73% male, with 16 ± 10 yr DM history. Sildenafil caused marginal improvements in echocardiographic measures of biventricular systolic function in DM subjects. Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved. However, the degree of PTAC did not change ( P = 0.93) and V̇o 2peak did not increase following sildenafil as compared with placebo (V̇o 2peak : 31.8 ± 9.7 vs. 32.1 ± 9.5 ml·min -1 ·kg -1 , P = 0.42). We conclude that sildenafil administration causes modest acute improvements in central hemodynamics but does not improve exercise capacity. This may be due to the mismatch in action of sildenafil on the pulmonary arteries rather than the distal pulmonary microvasculature and potential adverse effects on peripheral oxygen extraction. NEW & NOTEWORTHY This is one of the largest and most comprehensive studies of cardiopulmonary exercise performance in people with diabetes mellitus and to our knowledge the first to assess the effect of sildenafil using detailed echocardiographic measures during incremental exercise. Sildenafil attenuated the rise in pulmonary vascular resistance while augmenting cardiac output and intriguingly heart rate, without conferring any improvement in exercise capacity. The enhanced central hemodynamic indexes may have been offset by reduced peripheral O 2 extraction.",2019,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved.","['DM subjects were aged 44\u2009±\u200913 yr, 73% male, with 16\u2009±\u200910 yr DM history', 'Forty subjects with DM and 20 matched controls performed', 'people with diabetes mellitus (DM', 'DM subjects', 'people with diabetes mellitus']","['placebo', 'Sildenafil', 'sildenafil', 'cardiopulmonary exercise performance', 'cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion']","['cardiac output', 'heart rate', 'exercise performance', 'echocardiographic measures of biventricular systolic function', 'pulmonary artery systolic pressure and pulmonary vascular resistance', 'pulmonary vascular resistance', 'exercise capacity', 'pulmonary vascular resistance, cardiac output, and change in PTAC', 'Exercise capacity', 'exercise capacity (V̇o 2peak ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure (observable entity)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0760635', 'cui_str': 'PTAC'}]",40.0,0.431972,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Roberts', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Burns', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': ""St. Vincent's Department of Medicine, University of Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Prior', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00947.2018'] 1834,7636819,"Analgesia for venous cannulation: a comparison of EMLA (5 minutes application), lignocaine, ethyl chloride, and nothing.","Three commonly available local anaesthetics were compared, in a controlled trial, for use before venous cannulation. The pain of application of the local anaesthetic, the pain of cannulation, and the rate of successful cannulations were compared. The value of EMLA cream applied for 5 min was questioned. Venous cannulation with a 20G venflon was found to be significantly more painful than the application of any of the local anaesthetics (P < 0.01). Lignocaine 1%, injected subcutaneously, and ethyl chloride spray significantly reduced the pain of venous cannulation (P < 0.01). The use of lignocaine did not result in significantly more failed cannulations than the control group. It was concluded that local anaesthesia should be used before venous cannulation, even for 20G cannulae.",1995,"Lignocaine 1%, injected subcutaneously, and ethyl chloride spray significantly reduced the pain of venous cannulation (P < 0.01).",[],"['EMLA cream', 'EMLA', 'lignocaine', 'lignocaine, ethyl chloride, and nothing', 'ethyl chloride spray', 'Lignocaine']","['pain of venous cannulation', 'pain of application of the local anaesthetic, the pain of cannulation, and the rate of successful cannulations']",[],"[{'cui': 'C0360032', 'cui_str': 'EMLA Cream'}, {'cui': 'C0059079', 'cui_str': 'EMLA'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015058', 'cui_str': 'Ethyl Chloride'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0169982,"Lignocaine 1%, injected subcutaneously, and ethyl chloride spray significantly reduced the pain of venous cannulation (P < 0.01).","[{'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Selby', 'Affiliation': 'Anaesthetic Department, Hope Hospital, Lancashire, UK.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Bowles', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1835,31420960,A Mobile Phone App Featuring Cue Exposure Therapy As Aftercare for Alcohol Use Disorders: An Investigator-Blinded Randomized Controlled Trial.,"BACKGROUND Cue exposure therapy (CET) is a psychological approach developed to prepare individuals with alcohol use disorder (AUD) for confronting alcohol and associated stimuli in real life. CET has shown promise when treating AUD in group sessions, but it is unknown whether progressing from group sessions to using a mobile phone app is an effective delivery pathway. OBJECTIVE The objectives of this study were to investigate (1) whether CET as aftercare would increase the effectiveness of primary treatment with cognitive behavior therapy, and (2) whether CET delivered through a mobile phone app would be similarly effective to CET via group sessions. METHODS A total of 164 individuals with AUD were randomized to one of three groups: CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual. Study outcomes were assessed face-to-face at preaftercare, postaftercare, and again at 6 months after aftercare treatment. Generalized mixed models were used to compare the trajectories of the groups over time on drinking, cravings, and use of urge-specific coping skills (USCS). RESULTS In all, 153 of 164 individuals (93%) completed assessments both at posttreatment and 6-month follow-up assessments. No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time. Both CET group (predicted mean difference 5.99, SE 2.59, z=2.31, P=.02) and the CET app (predicted mean difference 4.90, SE 2.26, z=2.31, P=.02) showed increased use of USCS compared to aftercare as usual at posttreatment, but this effect was reduced at the 6-month follow-up. No differences were detected between the two experimental CET groups on any outcomes. CONCLUSIONS CET with USCS delivered as aftercare either via group sessions or a mobile phone app did not increase the effectiveness of primary treatment. This suggests that CET with USCS may not be an effective psychological approach for the aftercare of individuals treated for AUD. TRIAL REGISTRATION ClinicalTrials.gov NCT02298751; https://clinicaltrials.gov/ct2/show/NCT02298751.",2019,No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time.,['164 individuals with AUD'],"['CET as group aftercare (CET group), CET as fully automated mobile phone app aftercare (CET app), or aftercare as usual', 'CET', 'CET with USCS', 'Cue exposure therapy (CET', 'Mobile Phone App Featuring Cue Exposure Therapy', 'USCS']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]",[],164.0,0.0788876,No differences in the trajectories of predicted means were found between the experimental groups (CET group and app) compared with aftercare as usual on drinking and craving outcomes over time.,"[{'ForeName': 'Angelina Isabella', 'Initials': 'AI', 'LastName': 'Mellentin', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Technology Entrepreneurship and Innovation section, Mads Clausen Institute, University of Southern Denmark, Sønderborg, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mejldal', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Dorthe Grüner', 'Initials': 'DG', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}, {'ForeName': 'Elsebeth', 'Initials': 'E', 'LastName': 'Stenager', 'Affiliation': 'Brain Research-Inter-Disciplinary Guided Excellence, Department of Clinical Research, University of Southern Denmark, Odense Center, Denmark.'}]",JMIR mHealth and uHealth,['10.2196/13793'] 1836,32495306,Development of an Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake for Preventing Hypertension and Chronic Disease in Filipino Americans.,"Hypertension is a common chronic health condition affecting Filipino Americans. This pilot study examined the feasibility of addressing high rates of hypertension among Filipino Americans through the implementation of a culturally tailored education intervention. Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework. The study included pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake. The intervention to promote physical activity and reduce salt intake was conducted through two educational sessions and was accompanied by follow-up at 3 months and by the collection of urine samples for 24-h urinary sodium intake biomarker analysis. Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups. For systolic blood pressure, a reduction of 12.6 mmHg and an increase in 5.3 mmHg was observed in the intervention and control groups, respectively. Diastolic pressure decreased 3.8 mmHg for the intervention group and increased 5.6 mmHg among controls. The culturally tailored education intervention reported here represents a promising tool for blood pressure reduction in high-risk ethnic populations. The methods used were effective for the recruitment and retention of ethnic minorities in a community-based setting.",2020,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","['Filipino Americans', 'Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework']","['Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake', 'culturally tailored education intervention']","['Diastolic pressure', 'pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake', 'systolic blood pressure', 'urine sodium']","[{'cui': 'C0597918', 'cui_str': 'Filipino Americans'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}]",,0.0143801,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","[{'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA. grace.ma@temple.edu.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Bhimla', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Beeber', 'Affiliation': 'Hunter College, The City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Aczon', 'Affiliation': 'Filipino American Society of South Jersey Inc., Mount Laurel, NJ, 08084, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Sally Boyle', 'Initials': 'SB', 'LastName': 'Quinn', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Crystal A', 'Initials': 'CA', 'LastName': 'Gadegbeku', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00781-z'] 1837,32438316,Using simulation to teach undergraduate nursing and midwifery students research design.,"Whilst it is widely accepted that the ability to critique, interpret and integrate research is an integral part of the evidence-based practice of nursing and midwifery, teaching such skills to undergraduate students is equally recognised as challenging. From a student's perspective the theoretical aspects, concepts and language of research design may seem far removed from the imperative of developing skills and gaining clinical experience. Simulation has been widely demonstrated as an effective pedagogical approach to engage students in learning and developing practical skills. The 'hands-on' approach provides a cognitive link between theory and practice that is immediately relevant to the student. Simulation training has also been used in other areas of healthcare such as communication and ethics. However, the use of simulation to demonstrate the theoretical and practical aspects of research design to midwifery and nursing students has not been explored. This paper describes a novel approach to teaching undergraduate students fundamental concepts of randomised controlled trial design through their participation in a simulated research trial. Students experienced aspects such as consent, randomisation, intervention, data collection, analysis and interpretation. Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",2020,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.",[],['Simulation training'],[],[],"[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]",[],,0.0187677,"Post workshop evaluations suggest that students found the approach engaging, increased their knowledge and understanding of research and evidenced-based practice.","[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: nigel.lee@uq.edu.au.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Peacock', 'Affiliation': 'Chamberlain Building University of Queensland, St Lucia, 4072, Queensland, Australia. Electronic address: a.peacock2@uq.edu.au.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102804'] 1838,7069684,Work of the clinical psychologist in general practice: preliminary communication.,"A randomized, controlled trial to assess the value of a health centre-based clinical psychology service is described. Outcome is measured by means of (1) psychosocial rating scales; (2) drug costs; and (3) the costs of relevant hospital referrals. At the end of the first year, the six general practitioners had admitted 239 patients to the trial and of these 81 had been followed up for 34 weeks after entry. This preliminary report reviews the data obtained from these patients. The main finding is a tendency, which reaches statistical significance at some points, for those patients with access to a clinical psychologist to improve more rapidly on the psychosocial measures than the controls.",1982,"The main finding is a tendency, which reaches statistical significance at some points, for those patients with access to a clinical psychologist to improve more rapidly on the psychosocial measures than the controls.",['six general practitioners had admitted 239 patients to the trial and of these 81 had been followed up for 34 weeks after entry'],[],['means of (1) psychosocial rating scales; (2) drug costs; and (3) the costs of relevant hospital referrals'],"[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}]",239.0,0.0300875,"The main finding is a tendency, which reaches statistical significance at some points, for those patients with access to a clinical psychologist to improve more rapidly on the psychosocial measures than the controls.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'France', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1839,7007641,Moynihan needle--surgeons'choice.,,1981,,[],[],[],[],[],[],,0.0157132,,"[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pollock', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1840,7017122,Importance of adding neomycin to metronidazole for bowel preparation.,"A prospective randomized trial has investigated whether it is necessary to add oral neomycin to oral metronidazole as a means of preventing sepsis in elective colonic resection. Seventy-three patients completed the study; 41 received metronidazole and placebo neomycin and 32 received metronidazole and active neomycin. There was a significant reduction in the incidence of wound infection in patients receiving neomycin and metronidazole (22%) compared with metronidazole alone (51%, P<0.02). There was also a significant reduction in anaerobic infections in the group receiving metronidazole and neomycin compared with metronidazole alone (P<0.05). These results indicate that oral metronidazole alone is of no benefit for patients requiring elective colonic operations and that if oral metronidazole is advised it should always be given in combination with oral neomycin.",1980,"There was a significant reduction in the incidence of wound infection in patients receiving neomycin and metronidazole (22%) compared with metronidazole alone (51%, P<0.02).","['elective colonic resection', 'patients requiring elective colonic operations', 'Seventy-three patients completed the study; 41 received']","['metronidazole and placebo neomycin', 'metronidazole and active neomycin', 'metronidazole']","['incidence of wound infection', 'anaerobic infections']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",73.0,0.0165749,"There was a significant reduction in the incidence of wound infection in patients receiving neomycin and metronidazole (22%) compared with metronidazole alone (51%, P<0.02).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vallance', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Keighley', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1841,7017139,Value of an anal dilator after anal stretch for haemorrhoids.,"A prospective randomized trial compared anal stretch with or without continued dilatation for three months in 89 consecutive patients with haemorrhoids. Complications of therapy occurred in only 4 patients, 3 of whom had transient incontinence of flatus. When patients were reviewed four months after treatment, only 4 of 44 patients (9%) who used a dilator had not been improved and required additional therapy, compared with 15 of 42 patients (36%) who had anal stretch alone (P less than 0.02). It is concluded that the use of an anal dilator improves the results of anal stretch.",1981,"When patients were reviewed four months after treatment, only 4 of 44 patients (9%) who used a dilator had not been improved and required additional therapy, compared with 15 of 42 patients (36%) who had anal stretch alone (P less than 0.02).","['89 consecutive patients with haemorrhoids', 'haemorrhoids']",['anal stretch with or without continued dilatation'],"['transient incontinence of flatus', 'Complications of therapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}]","[{'cui': 'C0400300', 'cui_str': 'Forced manual dilatation of anus (procedure)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",89.0,0.0412356,"When patients were reviewed four months after treatment, only 4 of 44 patients (9%) who used a dilator had not been improved and required additional therapy, compared with 15 of 42 patients (36%) who had anal stretch alone (P less than 0.02).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Greca', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nevah', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hares', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Keighley', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1842,7040659,Effects of acupuncture in bronchial asthma: preliminary communication.,"Twenty patients randomly assigned to an experimental and a control group participated in a double blind study to assess the effectiveness of acupuncture in bronchial asthma, using the peak expiratory flow rate (PEFR) as an index of bronchial patency. All patients in the control group showed a significant improvement in their PEFR while only 3 patients in the treated group showed an improvement. A subjective improvement and a reduction in drug dosages were observed in both groups. It is concluded that acupuncture has a placebo effect in bronchial asthma.",1982,All patients in the control group showed a significant improvement in their PEFR while only 3 patients in the treated group showed an improvement.,['bronchial asthma'],['acupuncture'],"['PEFR', 'peak expiratory flow rate (PEFR']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}]",20.0,0.053265,All patients in the control group showed a significant improvement in their PEFR while only 3 patients in the treated group showed an improvement.,"[{'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Dias', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': ''}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Lionel', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1843,31416896,Pizza Leavening Technique Influences Postprandial Glucose Response: A Randomized Controlled Trial in Patients With Type 1 Diabetes.,,2019,,['Patients With Type 1 Diabetes'],[],['Pizza Leavening Technique Influences Postprandial Glucose Response'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0453577', 'cui_str': 'Pizza (substance)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.0734291,,"[{'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Cavagnuolo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Franco', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy annuzzi@unina.it.'}]",Diabetes care,['10.2337/dc19-0778'] 1844,31801622,Protocol for a phase III wait-listed cluster randomised controlled trial of an intervention for mental well-being through enhancing mental health literacy and improving work friendliness in Hong Kong.,"BACKGROUND Mental health has long been recognised as a major global health issue. Some work-related characteristics have been identified to be associated with common mental health problems, and thus the workplace is an important venue for the prevention of mental health problems and promoting mental wellness. Burnout is one of the important aspects of workplace organisational stressors and, in recent years, the lack of mental health literacy has also been identified as a fundamental issue. Studies have demonstrated that an improvement in mental health literacy is an effective measure for enhancing mental well-being. It would be prudent to combine an organisation-directed component and the enhancement of mental health literacy in an intervention programme. This trial will examine the novel approach of an intervention aiming to provide an evidence-based prevention programme. METHODS This study utilised a wait-listed cluster randomised control trial design. Using branch offices as the primary sampling units, employees from three large companies in different industries will be recruited. Upon enrolment and after the baseline assessment of the outcome measures, participants nested in the branch offices will be allocated to the intervention or wait-listed arms. The intervention programme comprises of two main elements: an organisation-directed component and individual-directed psychoeducation training. This intervention will be delivered by a senior social worker well-versed in workplace issues over a period of 3 months. The trial will determine whether an integrated workplace mental health literacy and well-being programme is effective in increasing the mental health literacy scores and reducing burnout and stress scores, as measured by standardised and validated scales. DISCUSSION If the trial results are in line with the hypothesis that supports the efficacy of the intervention programme, this will provide an evidence-based approach for an effective workplace mental well-being intervention programme that could not only enhance the understanding of mental health issues, but also reduce work-related burnout and stress as well as increase workers' quality of life. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000464167. Registered prospectively on 20 March 2019.",2019,"The trial will determine whether an integrated workplace mental health literacy and well-being programme is effective in increasing the mental health literacy scores and reducing burnout and stress scores, as measured by standardised and validated scales. ",[],['organisation-directed component and individual-directed psychoeducation training'],[],[],"[{'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0951915,"The trial will determine whether an integrated workplace mental health literacy and well-being programme is effective in increasing the mental health literacy scores and reducing burnout and stress scores, as measured by standardised and validated scales. ","[{'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Lam', 'Affiliation': 'Tung Wah College, 31 Wyloe Road, Homintin, Hong Kong SAR, Kowloon, China. Lawrence.Lam@uts.edu.au.'}, {'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Mental Health Association Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Lam', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 235 Jones Street, Ultimo, Sydney, Australia.'}]",Trials,['10.1186/s13063-019-3748-y'] 1845,7241426,Comparison of the effects of atropine and glycopyrrolate on various end-organs.,"Atropine and glycopyrrolate (glycopyrronium bromide), a quaternary ammonium drug, were evaluated in volunteers following intramuscular administration with respect to effects on various end-organs with cholinergic innervation. Glycopyrrolate appears to be five to six times more potent than atropine in its antisialogogue effect and also exhibits a selective, though prolonged, effect on salivary secretion and sweat gland activity. It has minimal cardiovascular, ocular and central nervous system effects.",1980,"Glycopyrrolate appears to be five to six times more potent than atropine in its antisialogogue effect and also exhibits a selective, though prolonged, effect on salivary secretion and sweat gland activity.",[],"['Atropine and glycopyrrolate (glycopyrronium bromide', 'atropine and glycopyrrolate', 'Glycopyrrolate', 'atropine']",['salivary secretion and sweat gland activity'],[],"[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0036104', 'cui_str': 'Salivation'}, {'cui': 'C0038989', 'cui_str': 'Sweat Glands'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0193141,"Glycopyrrolate appears to be five to six times more potent than atropine in its antisialogogue effect and also exhibits a selective, though prolonged, effect on salivary secretion and sweat gland activity.","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Mirakhur', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Dundee', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1846,7241435,Simple instructions for using pressurized aerosol bronchodilators.,"Although the manufacturers of pressurized aerosol bonchodilators issue instructions for using the inhalers, little or no experimental verification exists. Bronchodilatation has been measured after controlled inhalations of 500 μg terbutaline sulphate given in a systematic series of investigations to 8 patients with reversible airways obstruction at 2 different inhalation flow rates (25 1/min and 80 1/min), 3 different lung volumes (20%, 50% and 80% vital capacity) and followed by 2 different breath-holding pauses (4 and 10 seconds). The results indicate that patients may release the aerosol at any time during the course of a slow deep inhalation which should be followed by 10 seconds of breath-holding. This will ensure an optimal bronchodilator response.",1980,"Bronchodilatation has been measured after controlled inhalations of 500 μg terbutaline sulphate given in a systematic series of investigations to 8 patients with reversible airways obstruction at 2 different inhalation flow rates (25 1/min and 80 1/min), 3 different lung volumes (20%, 50% and 80% vital capacity) and followed by 2 different breath-holding pauses (4 and 10 seconds).","['8 patients with reversible airways obstruction at 2 different inhalation flow rates (25 1/min and 80 1/min), 3 different lung volumes (20%, 50% and 80% vital capacity) and followed by 2 different breath-holding pauses (4 and 10 seconds']",['terbutaline sulphate'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0235744', 'cui_str': 'Breath Holding'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0039543', 'cui_str': 'Terbutaline Sulfate'}]",[],8.0,0.0398986,"Bronchodilatation has been measured after controlled inhalations of 500 μg terbutaline sulphate given in a systematic series of investigations to 8 patients with reversible airways obstruction at 2 different inhalation flow rates (25 1/min and 80 1/min), 3 different lung volumes (20%, 50% and 80% vital capacity) and followed by 2 different breath-holding pauses (4 and 10 seconds).","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pavia', 'Affiliation': ''}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Clarke', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1847,7241441,Anaesthesia for bronchoscopy: examination of a standard technique.,"An anaesthetic technique for bronchoscopy is described, based on increments of methohexitone given in strict relation to body weight and time, suxamethonium being used to produce relaxation. There was no awareness in the 75 patients studied, while the recovery was rapid and unrelated to the duration of bronchoscopy. The efficacy of small aliquots of lignocaine in reducing injection pain was the same whether given before, or mixed with, the initial methohexitone injection. Other sequelae relating to the anaesthetic technique were minimal.",1980,"The efficacy of small aliquots of lignocaine in reducing injection pain was the same whether given before, or mixed with, the initial methohexitone injection.",[],['lignocaine'],"['duration of bronchoscopy', 'injection pain']",[],"[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0135948,"The efficacy of small aliquots of lignocaine in reducing injection pain was the same whether given before, or mixed with, the initial methohexitone injection.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Newell', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Collis', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1848,7040657,Saline flush: a simple method of reducing diazepam-induced thrombophlebitis.,"Five hundred outpatients undergoing endoscopy were admitted into a controlled trial comparing the incidence of thrombophlebitis following intravenous diazepam administered in the way, with the effects of either a saline flush following the diazepam or diluting the drug with the patient's own blood before injection ('barbotage'). The results were assessed using a questionnaire completed by patients two weeks after endoscopy; 80% replied. A saline flush reduced the incidence of side effects, particularly pain (P less than 0.05). 'Barbotage' gave the highest incidence of side effects. Saline flush is therefore recommended as a means of reducing the thrombophlebitis which may follow intravenous diazepam.",1982,"A saline flush reduced the incidence of side effects, particularly pain (P less than 0.05). '",['Five hundred outpatients undergoing endoscopy'],"['Saline flush', 'diazepam', 'diazepam-induced thrombophlebitis']","['incidence of side effects, particularly pain', 'side effects']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0040046', 'cui_str': 'Thrombophlebitis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",500.0,0.0627995,"A saline flush reduced the incidence of side effects, particularly pain (P less than 0.05). '","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Dutt', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1849,6971940,Expectation and patient preference -- does it matter?,"Admission to clinical trials is often based on the assumption of homogeneity of the population. A group of 60 patients, all with pain in the neck or shoulder of at least 3 months duration, were studied. Expectation was graded before treatments were started by sharing out 100 points between freedom from side effects, pain relief, depression relief, improved mobility, improved sleep and speed of action. A double-blind crossover study of two established anti-inflammatory analgesics and placebo was carried out. Using analogue scales, patients were asked to grade their response. Side effects were recorded, and preference was established at the end of the study.Although all the patients were in sufficient pain to require medical attention, some rated relief of depression, improvement in sleep or lack of side effects as more important than pain relief. Differences between drug and placebo were most clearly demonstrated in those patients whose main concern was improved mobility. In our view it is important to select patients who are in need of a dominant property of a drug for a trial of this property and this may have ramifications across the medical spectrum.",1980,Differences between drug and placebo were most clearly demonstrated in those patients whose main concern was improved mobility.,"['A group of 60 patients, all with pain in the neck or shoulder of at least 3 months duration, were studied']","['established anti-inflammatory analgesics and placebo', 'placebo']","['Side effects', 'pain relief, depression relief, improved mobility, improved sleep and speed of action', 'mobility']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0002773', 'cui_str': 'Analgesics, Anti-Inflammatory'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",100.0,0.0511351,Differences between drug and placebo were most clearly demonstrated in those patients whose main concern was improved mobility.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bloom', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molloy', 'Affiliation': ''}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Mace', 'Affiliation': ''}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Hamilton', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1850,31801600,Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial.,"BACKGROUND Knee osteoarthritis (KOA) is one of the most common bone and joint diseases. As one of the main non-drug therapies, acupuncture is widely used to treat KOA, although the evidence for its efficacy is inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of fire acupuncture in the treatment of mild to moderate KOA and to provide high-quality data for further research. METHODS/DESIGN This study is a prospective randomized controlled pilot trial in which 120 patients with mild to moderate KOA will be randomly allocated in equal proportions to a fire acupuncture group or a general acupuncture group. They will receive acupuncture for six sessions over 2 weeks. The primary end point is success rate, which will be calculated based on the change from baseline of the pain and function scores in the Western Ontario and McMaster Universities Osteoarthritis Index at 4 weeks. Secondary end points include the proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1β, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation from patients. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1800019162. Registered on 29 October 2018.",2019,"Secondary end points include the proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1β, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation from patients. ","['mild to moderate knee osteoarthritis', 'Knee osteoarthritis (KOA', '120 patients with mild to moderate KOA']","['fire acupuncture', 'acupuncture', 'Fire acupuncture', 'fire acupuncture group or a general acupuncture group']","['proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1β, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation', 'pain and function scores in the Western Ontario and McMaster Universities Osteoarthritis Index', 'success rate']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0005768'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}]",120.0,0.142329,"Secondary end points include the proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1β, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation from patients. ","[{'ForeName': 'Yuan-Bo', 'Initials': 'YB', 'LastName': 'Fu', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'San-Feng', 'Initials': 'SF', 'LastName': 'Sun', 'Affiliation': 'Beijing Huairou District Hospital of Traditional Chinese Medicine, No. 1 Houheng Street, Huairou District, Beijing, 101400, China.'}, {'ForeName': 'Hui-Lin', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Shao-Song', 'Initials': 'SS', 'LastName': 'Wang', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Du-Juan', 'Initials': 'DJ', 'LastName': 'Ge', 'Affiliation': 'Beijing Huairou District Hospital of Traditional Chinese Medicine, No. 1 Houheng Street, Huairou District, Beijing, 101400, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Beijing Huairou District Hospital of Traditional Chinese Medicine, No. 1 Houheng Street, Huairou District, Beijing, 101400, China.'}, {'ForeName': 'Rui-Li', 'Initials': 'RL', 'LastName': 'Liang', 'Affiliation': 'Beijing Huairou District Hospital of Traditional Chinese Medicine, No. 1 Houheng Street, Huairou District, Beijing, 101400, China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': 'Beijing Huairou District Hospital of Traditional Chinese Medicine, No. 1 Houheng Street, Huairou District, Beijing, 101400, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Jing-Qing', 'Initials': 'JQ', 'LastName': 'Sun', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China. sjqdoctor@163.com.'}, {'ForeName': 'Jun-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'The Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China. 847431304@qq.com.'}]",Trials,['10.1186/s13063-019-3744-2'] 1851,7005439,Role of suprapubic catheterization in retention of urine.,One hundred and nine male patients took part in a randomized trial of elective suprapubic or urethral catheterization in retention of urine. The self-retaining trocar suprapubic catheter proved safe and reliable in trained hands and its use was associated with a low incidence of side effects. The suprapubic catheter when used to allow continuous flow resection appeared to lead to decreased blood loss and reduced resection time. No decrease in urinary infection rate over the period of hospital stay was noted in the suprapubic group. The suprapubic catheter was more comfortable than the urethral and also allowed a trial of voiding prior to removal. Use of the suprapubic catheter was not associated with an increased hospital stay.,1980,The suprapubic catheter when used to allow continuous flow resection appeared to lead to decreased blood loss and reduced resection time.,['One hundred and nine male patients'],"['suprapubic catheter', 'suprapubic catheterization', 'elective suprapubic or urethral catheterization']","['blood loss and reduced resection time', 'urinary infection rate', 'hospital stay']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0150798', 'cui_str': 'Suprapubic catheter (physical object)'}, {'cui': 'C0205498', 'cui_str': 'Suprapubic approach (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1455681', 'cui_str': 'Insertion of urethral catheter (procedure)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",109.0,0.0177789,The suprapubic catheter when used to allow continuous flow resection appeared to lead to decreased blood loss and reduced resection time.,"[{'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Abrams', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Gaches', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Ashken', 'Affiliation': ''}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Green', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1852,31416692,"Safety and immunogenicity of the chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.","BACKGROUND Chlamydia is the most common sexually transmitted bacterial infection worldwide. National screening programmes and antibiotic treatment have failed to decrease incidence, and to date no vaccines against genital chlamydia have been tested in clinical trials. We aimed to assess the safety and immunogenicity, in humans, of a novel chlamydia vaccine based on a recombinant protein subunit (CTH522) in a prime-boost immunisation schedule. METHODS This phase 1, first-in-human, double-blind, parallel, randomised, placebo-controlled trial was done at Hammersmith Hospital in London, UK, in healthy women aged 19-45 years. Participants were randomly assigned (3:3:1) to three groups: CTH522 adjuvanted with CAF01 liposomes (CTH522:CAF01), CTH522 adjuvanted with aluminium hydroxide (CTH522:AH), or placebo (saline). Participants received three intramuscular injections of 85 μg vaccine (with adjuvant) or placebo to the deltoid region of the arm at 0, 1, and 4 months, followed by two intranasal administrations of 30 μg unadjuvanted vaccine or placebo (one in each nostril) at months 4·5 and 5·0. The primary outcome was safety and the secondary outcome was humoral immunogenicity (anti-CTH522 IgG seroconversion). This study is registered with Clinicaltrials.gov, number NCT02787109. FINDINGS Between Aug 15, 2016, and Feb 13, 2017, 35 women were randomly assigned (15 to CTH522:CAF01, 15 to CTH522:AH, and five to placebo). 32 (91%) received all five vaccinations and all participants were included in the intention-to-treat analyses. No related serious adverse reactions were reported, and the most frequent adverse events were mild local injection-site reactions, which were reported in all (15 [100%] of 15) participants in the two vaccine groups and in three (60%) of five participants in the placebo group (p=0·0526 for both comparisons). Intranasal vaccination was not associated with a higher frequency of related local reactions (reported in seven [47%] of 15 participants in the active treatment groups vs three [60%] of five in the placebo group; p=1·000). Both CTH522:CAF01 and CTH522:AH induced anti-CTH522 IgG seroconversion in 15 (100%) of 15 participants after five immunisations, whereas no participants in the placebo group seroconverted. CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH. INTERPRETATION CTH522 adjuvanted with either CAF01 or aluminium hydroxide appears to be safe and well tolerated. Both vaccines were immunogenic, although CTH522:CAF01 had a better immunogenicity profile, holding promise for further clinical development. FUNDING European Commission and The Innovation Fund Denmark.",2019,"CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH. ","['Between Aug 15, 2016, and Feb 13, 2017', '35 women', 'healthy women aged 19-45 years']","['CTH522 adjuvanted with CAF01 liposomes (CTH522:CAF01), CTH522 adjuvanted with aluminium hydroxide (CTH522:AH), or placebo (saline', 'CTH522:CAF01, 15 to CTH522:AH, and five to placebo', 'placebo', 'chlamydia vaccine candidate CTH522 adjuvanted with CAF01 liposomes or aluminium hydroxide', 'recombinant protein subunit (CTH522', 'CTH522:CAF01', 'intramuscular injections of 85 μg vaccine (with adjuvant) or placebo', 'vaccine or placebo', 'CAF01 or aluminium hydroxide']","['accelerated seroconversion, increased IgG titres', 'higher frequency of related local reactions', 'safe and well tolerated', 'safety and immunogenicity', 'humoral immunogenicity (anti-CTH522 IgG seroconversion', 'serious adverse reactions', 'anti-CTH522 IgG seroconversion']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",35.0,0.702909,"CTH522:CAF01 showed accelerated seroconversion, increased IgG titres, an enhanced mucosal antibody profile, and a more consistent cell-mediated immune response profile compared with CTH522:AH. ","[{'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Helene B', 'Initials': 'HB', 'LastName': 'Juel', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bang', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Cheeseman', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Dohn', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Max P', 'Initials': 'MP', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Korsholm', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anja W', 'Initials': 'AW', 'LastName': 'Olsen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'McFarlane', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Moen', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Ruhwald', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark. Electronic address: pa@ssi.dk.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Shattock', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Follmann', 'Affiliation': 'Department of Infectious Disease Immunology, Statens Serum Institut, Copenhagen, Denmark.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30279-8'] 1853,30987842,"Re: Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.155659,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soria', 'Affiliation': 'Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gontero', 'Affiliation': 'Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy. Electronic address: paolo.gontero@unito.it.'}]",European urology,['10.1016/j.eururo.2019.03.042'] 1854,31416685,"Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial.","BACKGROUND Transoral robotic surgery (TORS) with concurrent neck dissection has supplanted radiotherapy in the USA as the most common treatment for oropharyngeal squamous cell carcinoma (OPSCC), yet no randomised trials have compared these modalities. We aimed to evaluate differences in quality of life (QOL) 1 year after treatment. METHODS The ORATOR trial was an investigator-initiated, multicentre, international, open-label, parallel-group, phase 2, randomised study. Patients were enrolled at six hospitals in Canada and Australia. We randomly assigned (1:1) patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology). Following stratification by p16 status, patients were randomly assigned using a computer-generated randomisation list with permuted blocks of four. The primary endpoint was swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10-point improvement (a clinically meaningful change) in the TORS plus neck dissection group. All analyses were done by intention to treat. This study is registered with ClinicalTrials.gov (NCT01590355) and is active, but not currently recruiting. FINDINGS 68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017. Median follow-up was 25 months (IQR 20-33) for the radiotherapy group and 29 months (23-43) for the TORS plus neck dissection group. MDADI total scores at 1 year were mean 86·9 (SD 11·4) in the radiotherapy group versus 80·1 (13·0) in the TORS plus neck dissection group (p=0·042). There were more cases of neutropenia (six [18%] of 34 patients vs none of 34), hearing loss (13 [38%] vs five [15%]), and tinnitus (12 [35%] vs two [6%]) reported in the radiotherapy group than in the TORS plus neck dissection group, and more cases of trismus in the TORS plus neck dissection group (nine [26%] vs one [3%]). The most common adverse events in the radiotherapy group were dysphagia (n=6), hearing loss (n=6), and mucositis (n=4), all grade 3, and in the TORS plus neck dissection group, dysphagia (n=9, all grade 3) and there was one death caused by bleeding after TORS. INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Toxicity patterns differed between the groups. Patients with OPSCC should be informed about both treatment options. FUNDING Canadian Cancer Society Research Institute Grant (#701842), Ontario Institute for Cancer Research Clinician-Scientist research grant, and the Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers grant.",2019,"INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change.","['Patients were enrolled at six hospitals in Canada and Australia', 'oropharyngeal squamous cell carcinoma (OPSCC', 'patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to', '68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017', 'Patients with OPSCC', 'oropharyngeal squamous cell carcinoma (ORATOR']","['radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology', 'Radiotherapy', 'radiotherapy', 'transoral robotic surgery and neck dissection', 'Transoral robotic surgery (TORS) with concurrent neck dissection']","['Toxicity patterns', 'dysphagia', 'hearing loss', 'superior swallowing-related QOL scores', 'neutropenia', 'swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score', 'cases of trismus', 'dysphagia (n=6), hearing loss (n=6), and mucositis', 'quality of life (QOL', 'MDADI total scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Radiochemotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",68.0,0.207144,"INTERPRETATION Patients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change.","[{'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada. Electronic address: anthony.nichols@lhsc.on.ca.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, ON, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Prisman', 'Affiliation': 'Department of Otolaryngology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berthelet', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': 'Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Goldstein', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hier', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Sultanem', 'Affiliation': 'Department of Radiation Oncology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Richardson', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mlynarek', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Suren', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Hien', 'Initials': 'H', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'J Alex', 'Initials': 'JA', 'LastName': 'Hammond', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medical Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Corsten', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Johnson-Obaseki', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Department of Radiation Oncology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odell', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Department of Audiology, London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Bret', 'Initials': 'B', 'LastName': 'Wehrli', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Kwan', 'Affiliation': 'Department of Pathology, Western University, London, ON, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Radiation Oncology, Western University, London, ON, Canada.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30410-3'] 1855,31418424,Counseling With Guided Use of a Mobile Well-Being App for Students Experiencing Anxiety or Depression: Clinical Outcomes of a Feasibility Trial Embedded in a Student Counseling Service.,"BACKGROUND Anxiety and depression continue to be prominent experiences of students approaching their university counseling service. These services face unique challenges to ensure that they continue to offer quality support with fewer resources to a growing student population. The convenience and availability of mobile phone apps offer innovative solutions to address therapeutic challenges and expand the reach of traditional support. OBJECTIVE The primary aim of this study was to establish the feasibility of a trial in which guided use of a mobile phone well-being app was introduced into a student counseling service and offered as an adjunct to face-to-face counseling. METHODS The feasibility trial used a two-arm, parallel nonrandomized design comparing counseling alone (treatment as usual, or TAU) versus counseling supplemented with guided use of a mobile phone well-being app (intervention) for 38 university students experiencing moderate anxiety or depression. Students in both conditions received up to 6 sessions of face-to-face counseling within a 3-month period. Students who approached the counseling service and were accepted for counseling were invited to join the trial. Feasibility factors evaluated include recruitment duration, treatment preference, randomization acceptability, and intervention fidelity. Clinical outcomes and clinical change were assessed with routine clinical outcome measures administered every counseling session and follow-up phases at 3 and 6 months after recruitment. RESULTS Both groups demonstrated reduced clinical severity by the end of counseling. This was particularly noticeable for depression, social anxiety, and hostility, whereby clients moved from elevated clinical to low clinical or from low clinical to nonclinical by the end of the intervention. By the 6-month follow-up, TAU clients' (n=18) anxiety had increased whereas intervention clients' (n=20) anxiety continued to decrease, and this group difference was significant (Generalized Anxiety Disorder-7: t 22 =3.46, P=.002). This group difference was not replicated for levels of depression: students in both groups continued to decrease their levels of depression by a similar amount at the 6-month follow-up (Physical Health Questionnaire-9: t 22 =1.30, P=.21). CONCLUSION Supplementing face-to-face counseling with guided use of a well-being app is a feasible and acceptable treatment option for university students experiencing moderate anxiety or depression. The feasibility trial was successfully embedded into a university counseling service without denying access to treatment and with minimal disruption to the service. This study provides preliminary evidence for using a well-being app to maintain clinical improvements for anxiety following the completion of counseling. The design of the feasibility trial provides the groundwork for the development of future pilot trials and definitive trials embedded in a student counseling service. TRIAL REGISTRATION ISRCTN registry ISRCTN55102899; http://www.isrctn.com/ISRCTN55102899.",2019,"This group difference was not replicated for levels of depression: students in both groups continued to decrease their levels of depression by a similar amount at the 6-month follow-up (Physical Health Questionnaire-9: t 22 =1.30, P=.21). ","['students approaching their university counseling service', 'Students Experiencing Anxiety or Depression', 'Students who approached the counseling service and were accepted for counseling were invited to join the trial', 'university students experiencing moderate anxiety or depression', '38 university students experiencing moderate anxiety or depression']","['Student Counseling Service', 'Counseling With Guided Use of a Mobile Well-Being App', 'counseling alone (treatment as usual, or TAU) versus counseling supplemented with guided use of a mobile phone well-being app (intervention']","['clinical severity', ""intervention clients' (n=20) anxiety"", 'levels of depression', 'depression, social anxiety, and hostility', 'recruitment duration, treatment preference, randomization acceptability, and intervention fidelity']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0542296', 'cui_str': 'Counselling service'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0231402', 'cui_str': 'Moderate anxiety (finding)'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0542296', 'cui_str': 'Counselling service'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0020039', 'cui_str': 'Hostility'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0409424,"This group difference was not replicated for levels of depression: students in both groups continued to decrease their levels of depression by a similar amount at the 6-month follow-up (Physical Health Questionnaire-9: t 22 =1.30, P=.21). ","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Broglia', 'Affiliation': 'Research Department, British Association for Counselling and Psychotherapy, Leicestershire, United Kingdom.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Millings', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barkham', 'Affiliation': 'Department of Psychology, University of Sheffield, Sheffield, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14318'] 1856,7014886,Adjuvant chemotherapy and immunotherapy for colorectal cancer: preliminary communication.,"Following surgical resection of Dukes' B or C colorectal cancers 72 patients have been randomly allocated to receive: 5-fluorouracil; or 5-fluorouracil and levamisole; or no treatment. Adjuvant treatment was continued for one year. 66 patients remain evaluable for up to 24 months. Preliminary results show no significant differences in survival or recurrence rates. Two patients receiving 5-fluorouracil and levamisole developed severe, but reversible, neutropenia. Other side effects were uncommon.",1980,Preliminary results show no significant differences in survival or recurrence rates.,"['colorectal cancer', '66 patients remain evaluable for up to 24 months', 'cancers 72 patients']","['5-fluorouracil and levamisole', ""surgical resection of Dukes' B or C colorectal"", 'Adjuvant chemotherapy and immunotherapy', '5-fluorouracil']","['survival or recurrence rates', 'reversible, neutropenia']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023556', 'cui_str': 'Levamisole'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",72.0,0.0177043,Preliminary results show no significant differences in survival or recurrence rates.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bancewicz', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Calman', 'Affiliation': ''}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Macpherson', 'Affiliation': ''}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'McArdle', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'McVie', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Soukop', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1857,6834370,Effect of pindolol on stress-related disturbances of musical performance: preliminary communication.,The effect of 5 mg pindolol on stress-induced disturbances of performance were assessed in 30 professional musicians. An overall inverse relationship was found between anxiety and musical performance. Reduction in anxiety by administration of pindolol was associated with a subjective improvement in performance. A stress-related tachycardia and increase in systolic blood pressure were attenuated. Pindolol had no effect on peak flow measurements.,1983,Pindolol had no effect on peak flow measurements.,['30 professional musicians'],"['Pindolol', 'pindolol']","['anxiety and musical performance', 'anxiety', 'systolic blood pressure', 'peak flow measurements', 'stress-related disturbances of musical performance', 'stress-induced disturbances of performance']",[],"[{'cui': 'C0031937', 'cui_str': 'Pindolol'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",30.0,0.0363081,Pindolol had no effect on peak flow measurements.,"[{'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Burgoyne', 'Affiliation': ''}, {'ForeName': 'I T', 'Initials': 'IT', 'LastName': 'Savage', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1858,6864702,Intravenous glycopyrrolate and atropine at induction of anaesthesia: a comparison.,"In unpremedicated patients presenting for general anaesthesia for electroconvulsive therapy (ECT), the use of atropine combined with methohexitone as an intravenous induction agent was found to produce a significantly greater increase in heart rate than glycopyrrolate in similar combination. There was no difference in the antisialogogue effect of the two drugs at the doses used, and both drugs provided similar protection against the effects of suxamethonium and ECT on heart rate.",1983,"There was no difference in the antisialogogue effect of the two drugs at the doses used, and both drugs provided similar protection against the effects of suxamethonium and ECT on heart rate.",['unpremedicated patients presenting for general anaesthesia for electroconvulsive therapy (ECT'],"['atropine combined with methohexitone', 'suxamethonium and ECT', 'glycopyrrolate', 'glycopyrrolate and atropine']","['antisialogogue effect', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025668', 'cui_str': 'Methohexital'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0184012,"There was no difference in the antisialogogue effect of the two drugs at the doses used, and both drugs provided similar protection against the effects of suxamethonium and ECT on heart rate.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Greenan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dewar', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Jones', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1859,31809358,Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.,"BACKGROUND Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety. SETTING Two high-volume facilities providing MC near Harare, Zimbabwe. METHODS A prospective, unblinded, noninferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n = 362) responded to a daily text with in-person follow-up only if desired or an adverse event (AE) was suspected. The control group (n = 359) received routine in-person visits. All men were asked to return on postoperative day 14 for review. AEs at ≤day 14 visit and the number of in-person visits were compared between the groups. RESULTS Cumulative AEs were identified in 0.84% [95% confidence interval (CI): 0.28 to 2.43] among routine care men as compared with 1.88% (95% CI: 0.86 to 4.03) of 2wT participants. Noninferiority cannot be ruled out (95% CI: -∞ to +2.72); however, AE rates did not differ between the groups (P = 0.32). 2wT men attended an average of 0.30 visits as compared with 1.69 visits among routine care men, a significant reduction (P < 0.001). CONCLUSIONS Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up.",2020,"Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment.","['722 adult MC clients with cell phones randomized 1:1', '2wT clients (n = 362', ""Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program"", '2wT']",['routine in-person visits'],"['Provider Workload', 'AE rates', 'number of in-person visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",722.0,0.139752,"Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment.","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Patricia T', 'Initials': 'PT', 'LastName': 'Gundidza', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002198'] 1860,31805981,Effects of combining functional exercises with exercise training on daily physical activities and functionality in patients with COPD: a protocol for a randomized clinical trial.,"INTRODUCTION Functional training has been shown to be a viable alternative for the elderly and patients with chronic obstructive pulmonary disease (COPD). However, whether the combination of this type of training with aerobic and resistance training, commonly performed in pulmonary rehabilitation (PR) programs, induces more pronounced effects on daily physical activities and functionality remains unclear. The aims of the study will be to evaluate the short-term and sustained effects of the combination of a functional circuit program with a training program consisting of aerobic and resistance exercise. METHODS In this randomized controlled trial, patients with COPD will be randomly assigned (1:1:1) to an 8-week training program to follow one of the three a priori defined groups: (I) resistance and aerobic and functional exercises, (II) a conventional program including only resistance and aerobic exercises, or (III) a usual care program. Patients will be evaluated before and upon completion of 8 weeks of training regarding physical activity in daily life (PADL) using an activity monitor (accelerometer), activities of daily living (London Chest Activity of Daily Living), functional exercise capacity (6-minute walk test), and muscle strength (dynamometry). Additionally, the sustained effects of the interventions will be evaluated 22 weeks after commencing the study. DISCUSSION The inclusion of a protocol of functional physical training in the training conventionally performed by patients with COPD as an alternative to increase PADL and functionality may provide subsidies for the treatment of these patients, representing an advance and impacting on the physical training of patients with COPD. TRIAL REGISTRATION Brazilian Clinical Trials Registry (ReBEC) ID: RBR-3zmh3r. Registered: March 7, 2018.",2019,"Patients will be evaluated before and upon completion of 8 weeks of training regarding physical activity in daily life (PADL) using an activity monitor (accelerometer), activities of daily living (London Chest Activity of Daily Living), functional exercise capacity (6-minute walk test), and muscle strength (dynamometry).","['patients with COPD', 'elderly and patients with chronic obstructive pulmonary disease (COPD']","['functional circuit program', 'functional exercises with exercise training', 'functional physical training', 'RBR-3zmh3r', 'resistance and aerobic and functional exercises, (II) a conventional program including only resistance and aerobic exercises, or (III) a usual care program']","['daily physical activities and functionality', 'activity monitor (accelerometer), activities of daily living (London Chest Activity of Daily Living), functional exercise capacity (6-minute walk test), and muscle strength (dynamometry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0556323,"Patients will be evaluated before and upon completion of 8 weeks of training regarding physical activity in daily life (PADL) using an activity monitor (accelerometer), activities of daily living (London Chest Activity of Daily Living), functional exercise capacity (6-minute walk test), and muscle strength (dynamometry).","[{'ForeName': 'Fabiano Francisco', 'Initials': 'FF', 'LastName': 'de Lima', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil. fabiano_ffl@hotmail.com.'}, {'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Camillo', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Rehabilitation Sciences, State University of Londrina (UEL), Avenida Robert Koch, 60 - Vila Operária, 86038-350, Londrina, Brazil.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'Grigoletto', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Juliana Souza', 'Initials': 'JS', 'LastName': 'Uzeloto', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Franciele Marques', 'Initials': 'FM', 'LastName': 'Vanderlei', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Dionei', 'Initials': 'D', 'LastName': 'Ramos', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}, {'ForeName': 'Ercy Mara Cipulo', 'Initials': 'EMC', 'LastName': 'Ramos', 'Affiliation': 'Department of Physiotherapy, Postgraduate Program in Physiotherapy, São Paulo State University (UNESP), Rua Roberto Simonsen, No. 305, Presidente Prudente, São Paulo, 19060-900, Brazil.'}]",Trials,['10.1186/s13063-019-3780-y'] 1861,6457152,Effect of inhaled alpha-blocker on airflow obstruction in asthma.,A controlled study of the effect on airflow obstruction of 30 mg of the alpha-blocker thymoxamine given by inhalation is reported in 10 patients with chronic stable asthma. No significant change in peak expiratory flow rate was seen with either thymoxamine or placebo in any patient. Alpha-adrenergic receptors are therefore unlikely to contribute significantly to resting bronchomotor tone in chronic stable asthma.,1981,No significant change in peak expiratory flow rate was seen with either thymoxamine or placebo in any patient.,"['10 patients with chronic stable asthma', 'airflow obstruction in asthma']","['alpha-blocker thymoxamine', 'inhaled alpha-blocker', 'thymoxamine or placebo']",['peak expiratory flow rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0040108', 'cui_str': 'thymoxamine'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}]",10.0,0.0195885,No significant change in peak expiratory flow rate was seen with either thymoxamine or placebo in any patient.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ayres', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Cochrane', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1862,6737407,Controlled study of self-exposure treatment for phobics: preliminary communication.,"Patients with phobic disorder (mainly agoraphobics ) of minimum one year duration were treated by self-administered exposure in vivo treatment. Seventy-one patients were randomly assigned to one of three groups: (A) book-instructed, (B) computer-instructed, or (C) therapist-instructed. All three groups improved significantly to a similar extent on various phobic measures at the end of the treatment and maintained their treatment gains at 6-month follow up. Mean clinicians' time spent with each patient was 40 minutes, 4.2 hours and 3.2 hours in group A, B and C respectively. Similar small numbers of patients defaulted from each group.",1984,All three groups improved significantly to a similar extent on various phobic measures at the end of the treatment and maintained their treatment gains at 6-month follow up.,"['Patients with phobic disorder (mainly agoraphobics ) of minimum one year duration', 'phobics', 'Seventy-one patients']","['book-instructed, (B) computer-instructed, or (C) therapist-instructed']",['various phobic measures'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}]","[{'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",71.0,0.0125399,All three groups improved significantly to a similar extent on various phobic measures at the end of the treatment and maintained their treatment gains at 6-month follow up.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Marks', 'Affiliation': ''}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1863,6737408,Controlled comparison of three interventions for mother and toddler problems: preliminary communication.,"This paper summarizes the preliminary thinking, the hypotheses and design and some preliminary results of a large community-based intervention project which is currently underway in the North East of England.",1984,"This paper summarizes the preliminary thinking, the hypotheses and design and some preliminary results of a large community-based intervention project which is currently underway in the North East of England.",['mother and toddler problems'],[],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",[],[],,0.011608,"This paper summarizes the preliminary thinking, the hypotheses and design and some preliminary results of a large community-based intervention project which is currently underway in the North East of England.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Nicol', 'Affiliation': ''}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Stretch', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Davison', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fundudis', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1864,32141968,Parameterization of the mid-trimester drop in blood pressure trajectory during pregnancy and its utility for predicting preeclampsia.,"OBJECTIVES The purpose of this study was to parameterize mid-trimester drop in blood pressure (BP) trajectory during pregnancy and to evaluate its utility for predicting preeclampsia. METHODS To develop parametric models for BP trajectory during pregnancy, we used data from 7923 Chinese pregnant women with 24 810 routine antenatal care visits. Then, we evaluated the utility of BP trajectory parameters for predicting clinician-diagnosed preeclampsia in a separate sample of 3524 pregnant women from a randomized controlled trial of prenatal vitamin supplementation conducted in the same area. We focused on parameters related to the mid-trimester BP drop, including the gestational age and BP value at the nadir (lowest point), change in BP, velocity, and area under curve during two periods (from 12 weeks of gestation to the nadir and from the nadir to 33 weeks of gestation). RESULTS All participants in our analysis had a mid-pregnancy drop in their SBP, DBP, and mean arterial pressure (MAP) trajectories. There were high correlations (|r| > 0.90) among trajectory parameters of the same BP measure. The final prediction model included selective parameters of SBP, DBP, and MAP trajectories, prepregnancy BMI and gestational age at the first antenatal care visit. The area under the receiver-operating curve for predicting preeclampsia was 0.886 (95% confidence interval 0.846--0.926) in the training dataset and 0.802 (0.708--0.895) in the validation dataset. CONCLUSION Our novel BP trajectory parameters are informative and can predict preeclampsia at a clinically acceptable level.",2020,The area under the receiver-operating curve for predicting preeclampsia was 0.886,"['3524 pregnant women', '7923 Chinese pregnant women with 24\u200a810 routine antenatal care visits']",['prenatal vitamin supplementation'],"['gestational age and BP value at the nadir (lowest point), change in BP, velocity, and area under curve', 'blood pressure (BP) trajectory', 'blood pressure trajectory', 'selective parameters of SBP, DBP, and MAP trajectories, prepregnancy BMI and gestational age at the first antenatal care visit', 'SBP, DBP, and mean arterial pressure (MAP) trajectories']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}]","[{'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",3524.0,0.0408078,The area under the receiver-operating curve for predicting preeclampsia was 0.886,"[{'ForeName': 'Baibing', 'Initials': 'B', 'LastName': 'Mi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Division of Behavioral Medicine, Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, New York, USA.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Danmeng', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Fangliang', 'Initials': 'F', 'LastName': 'Lei', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Xuelan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology and Obstetrics, First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Abdal Aziz T', 'Initials': 'AAT', 'LastName': 'Shittu', 'Affiliation': 'Division of Behavioral Medicine, Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, New York, USA.'}, {'ForeName': 'Shaonong', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}]",Journal of hypertension,['10.1097/HJH.0000000000002395'] 1865,32200848,Re: Ahmed et al.: A prospective randomized trial comparing Hydrus and iStent micro-invasive glaucoma surgery implants for standalone treatment of open-angle glaucoma: The COMPARE Study (Ophthalmology. 2020;127:52-61).,,2020,,['open-angle glaucoma'],['Hydrus and iStent micro-invasive glaucoma surgery implants'],[],"[{'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1706188', 'cui_str': 'Glaucoma surgery specialty'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]",[],,0.0225743,,"[{'ForeName': 'Albert S', 'Initials': 'AS', 'LastName': 'Khouri', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey. Electronic address: albert.khouri@rutgers.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.034'] 1866,31211691,Task-related fMRI BOLD response to hyperinsulinemia in healthy older adults.,"BACKGROUND There is growing evidence to suggest that the brain is an important target for insulin action, and that states of insulin resistance may extend to the CNS with detrimental effects on cognitive functioning. Although the effect of systemic insulin resistance on peripheral organs is well-studied, the degree to which insulin impacts brain function in vivo remains unclear. METHODS This randomized, single-blinded, 2-way-crossover, sham-controlled, pilot study determined the effects of hyperinsulinemia on fMRI brain activation during a 2-back working memory task in 9 healthy older adults (aged 57-79 years). Each participant underwent two clamp procedures (an insulin infusion and a saline placebo infusion, with normoglycemia maintained during both conditions), to examine the effects of hyperinsulinemia on task performance and associated blood-oxygen-level dependent (BOLD) signal using fMRI. RESULTS Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task. Further, the degree of increased task-related activation in select brain regions correlated with greater systemic insulin sensitivity, as well as decreased reaction times and performance accuracy between experimental conditions. CONCLUSION Together, these findings provide evidence of insulin action in the CNS among older adults during periods of sustained cognitive demand, with the greatest effects noted for individuals with highest systemic insulin sensitivity. FUNDING This work was funded by the National Institutes of Health (5R21AG051958, 2016).",2019,"RESULTS Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task.","['9 healthy older adults (aged 57-79 years', 'healthy older adults']","['clamp procedures (an insulin infusion and a saline placebo', 'hyperinsulinemia']","['Task-related fMRI BOLD response', 'spatial extent and relative strength of task-related BOLD signal', 'reaction times and performance accuracy', 'blood-oxygen-level dependent (BOLD) signal using fMRI']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",9.0,0.108205,"RESULTS Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task.","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Williams', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Bianca A', 'Initials': 'BA', 'LastName': 'Trombetta', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Rabab Z', 'Initials': 'RZ', 'LastName': 'Jafri', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Koenig', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Chase D', 'Initials': 'CD', 'LastName': 'Wennick', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Becky C', 'Initials': 'BC', 'LastName': 'Carlyle', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'Rexford S', 'Initials': 'RS', 'LastName': 'Ahima', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Russell', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Salat', 'Affiliation': 'Brain Aging and Dementia Laboratory, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Arnold', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}]",JCI insight,['10.1172/jci.insight.129700'] 1867,31411963,Neutrophil-to-lymphocyte Ratio as a Predictive Marker of Response to Abiraterone Acetate: A Retrospective Analysis of the COU302 Study.,"BACKGROUND The neutrophil-lymphocyte ratio (NLR) is an inexpensive and accessible prognostic marker for many cancers, including metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE In this study, we assess the role of NLR as a predictive biomarker through a retrospective analysis of the pivotal COU302 study of abiraterone acetate (AA) as first-line therapy for men with asymptomatic or minimally symptomatic mCRPC. DESIGN, SETTING, AND PARTICIPANTS The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive AA plus prednisone or prednisone as first-line treatment. Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival were evaluated. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Descriptive statistics, as well as Kaplan-Meier and Cox survival models were used to assess the effect of baseline NLR and changes in NLR on response to AA plus prednisone versus prednisone, with adjustment for important covariates. RESULTS AND LIMITATIONS Among the 1082 patients who received treatment, baseline NLR values showed no significant differences according to baseline covariates except for albumin. Baseline variables were similar between dichotomous groups with an NLR cutoff of 2.5, except for a lower proportion of patients with >10 bone metastases in the NLR <2.5 group. Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models. No significant differences were seen in time to radiographic progression. In separate analyses, an increase or decrease in NLR by 2 from treatment baseline did not clearly signal subsequent lack of benefit with continued AA. CONCLUSIONS Our results suggest that baseline NLR may be able to predict response to AA in men with asymptomatic mCRPC but that changes in NLR during treatment are insufficient to guide treatment. Further validation studies are warranted. PATIENT SUMMARY In this report, we look at the ratio of circulating immune cells as a predictor of response to abiraterone acetate (AA), using data from a large trial. Our results suggest that this ratio derived from routinely obtained bloodwork can predict which patients respond better to AA.",2020,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","['The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive', 'men with asymptomatic or minimally symptomatic mCRPC', '1082 patients']","['prednisone', 'placebo', 'Abiraterone Acetate', 'abiraterone acetate (AA', 'AA plus prednisone or prednisone']","['Kaplan-Meier and Cox survival models', 'Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival', 'time to radiographic progression', 'overall survival and PSA response', 'NLR']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",1082.0,0.217367,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Loubersac', 'Affiliation': 'Centre Hospitalier Universitaire Nantes, Nantes, France.'}, {'ForeName': 'Molière', 'Initials': 'M', 'LastName': 'Nguile-Makao', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pouliot', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fradet', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Toren', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada. Electronic address: paul.toren@crchudequebec.ulaval.ca.'}]",European urology oncology,['10.1016/j.euo.2019.01.009'] 1868,6173480,Buscopan or glucagon for endoscopic cannulation of ampulla of vater?,The number of intravenous injections of hyoscine-N-butylbromide (Buscopan) or glucagon required to maintain relaxation of the duodenum during endoscopic retrograde cholangiopancreatography (ERCP) were compared in a double blind trial of 55 patients. There was no significant difference in the number of injections. Serum amylase levels after the use of both relaxants were compared in 50 patients undergoing ERCP. No significant difference in the levels of hyperamylasaemia were found.,1982,The number of intravenous injections of hyoscine-N-butylbromide (Buscopan) or glucagon required to maintain relaxation of the duodenum during endoscopic retrograde cholangiopancreatography (ERCP) were compared in a double blind trial of 55 patients.,"['55 patients', '50 patients undergoing ERCP']","['hyoscine-N-butylbromide (Buscopan) or glucagon', 'Buscopan or glucagon', 'endoscopic retrograde cholangiopancreatography (ERCP']","['levels of hyperamylasaemia', 'number of injections', 'Serum amylase levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0006519', 'cui_str': 'butylscopolamine bromide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0701019', 'cui_str': 'Buscopan'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0221773', 'cui_str': 'Hyperamylasemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0428349', 'cui_str': 'Serum amylase (pancreatic) measurement'}]",50.0,0.0713823,The number of intravenous injections of hyoscine-N-butylbromide (Buscopan) or glucagon required to maintain relaxation of the duodenum during endoscopic retrograde cholangiopancreatography (ERCP) were compared in a double blind trial of 55 patients.,"[{'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Hannigan', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Axon', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Avery', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1869,32134720,Digital Cognitive Behavioral Therapy for Insomnia for Adolescents With Mental Health Problems: Feasibility Open Trial.,"BACKGROUND Insomnia in adolescents is common, persistent, and associated with poor mental health including anxiety and depression. Insomnia in adolescents attending child mental health services is seldom directly treated, and the effects of digital cognitive behavioral therapy (CBT) for insomnia (CBTi) on the mental health of adolescents with significant mental health problems are unknown. OBJECTIVE This open study aimed to assess the feasibility of adding supported Web-based CBT for insomnia to the usual care of young people aged 14 to 17 years attending specialist child and adolescent mental health services (CAMHS). METHODS A total of 39 adolescents with insomnia aged 14 to 17 years attending specialist CAMHS were assessed and offered digital CBTi. The digital intervention was Sleepio, an evidence-based, self-directed, fully automated CBTi that has proven effective in multiple randomized controlled trials with adults. Self-report assessments of sleep (Sleep Condition Indicator [SCI], Insomnia Severity Scale, and Web- or app-based sleep diaries), anxiety (Revised Child Anxiety and Depression Scale [RCADS]), and depression (Mood and Feelings Questionnaire [MFQ]) were completed at baseline and post intervention. Postuse interviews assessed satisfaction with digital CBTi. RESULTS Average baseline sleep efficiency was very poor (53%), with participants spending an average of 9.6 hours in bed but only 5.1 hours asleep. All participants scored less than 17 on the SCI, with 92% (36/39) participants scoring 15 or greater on the Insomnia Severity Scale, suggesting clinical insomnia. Of the 39 participants, 36 (92%) scored 27 or greater on the MFQ for major depression and 20 (51%) had clinically elevated symptoms of anxiety. The majority of participants (38/49, 78%) were not having any treatment for their insomnia, with the remaining 25% (12/49) receiving medication. Sleepio was acceptable, with 77% (30/39) of the participants activating their account and 54% (21/39) completing the program. Satisfaction was high, with 84% (16/19) of the participants finding Sleepio helpful, 95% (18/19) indicating that they would recommend it to a friend, and 37% (7/19) expressing a definite preference for a digital intervention. Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety (RCADS: P=.005). CONCLUSIONS Our study has a number of methodological limitations, particularly the small sample size, absence of a comparison group and no follow-up assessment. Nonetheless, our findings are encouraging and suggest that digital CBTi for young people with mental health problems might offer an acceptable and an effective way to improve both sleep and mental health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.2196/11324.",2020,"Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety","['adolescents attending child mental health services', 'young people aged 14 to 17 years attending specialist child and adolescent mental health services (CAMHS', 'Adolescents With Mental Health Problems', '39 adolescents with insomnia aged 14 to 17 years attending specialist CAMHS', 'young people with mental health problems']","['RCADS', 'Digital Cognitive Behavioral Therapy', 'digital cognitive behavioral therapy (CBT', 'adding supported Web-based CBT']","['weekly diaries of sleep efficiency', 'anxiety', 'Insomnia', 'clinically elevated symptoms of anxiety', 'Insomnia Severity Scale, suggesting clinical insomnia', 'Self-report assessments of sleep (Sleep Condition Indicator [SCI], Insomnia Severity Scale, and Web- or app-based sleep diaries), anxiety (Revised Child Anxiety and Depression Scale [RCADS]), and depression (Mood and Feelings Questionnaire [MFQ', 'Satisfaction', 'sleep quality']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4305166', 'cui_str': ""Revised Children's Anxiety and Depression Scale (assessment scale)""}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",39.0,0.0612398,"Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety","[{'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Cliffe', 'Affiliation': 'Department of Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Croker', 'Affiliation': 'Child and Adolescent Mental Health Service, Oxford Health NHS Foundation Trust, Temple House, Keynsham, United Kingdom.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Denne', 'Affiliation': 'Child and Adolescent Mental Health Service, Oxford Health NHS Foundation Trust, Temple House, Keynsham, United Kingdom.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Child and Adolescent Mental Health Service, Oxford Health NHS Foundation Trust, Temple House, Keynsham, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stallard', 'Affiliation': 'Department of Health, University of Bath, Bath, United Kingdom.'}]",JMIR mental health,['10.2196/14842'] 1870,6512802,Chemoprophylaxis in major head and neck surgery.,Wound infections are a significant complication following major oncological head and neck surgery. In view of the controversy surrounding the use of chemoprophylaxis a controlled trial was designed. Intravenous Augmentin (amoxycillin and clavulanic acid) was shown to reduce significantly (P less than 0.025) the incidence of postoperative sepsis.,1984,Intravenous Augmentin (amoxycillin and clavulanic acid) was shown to reduce significantly (P less than 0.025) the incidence of postoperative sepsis.,"['major oncological head and neck surgery', 'major head and neck surgery']","['Chemoprophylaxis', 'Intravenous Augmentin (amoxycillin and clavulanic acid']",['incidence of postoperative sepsis'],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0591132', 'cui_str': 'Augmentin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3698200', 'cui_str': 'Postoperative sepsis'}]",,0.0398979,Intravenous Augmentin (amoxycillin and clavulanic acid) was shown to reduce significantly (P less than 0.025) the incidence of postoperative sepsis.,"[{'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Raine', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Bartzokas', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Stell', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gallway', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Corkill', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1871,32138607,Cluster vs. traditional training programmes: changes in the force-velocity relationship.,"This randomised controlled study examined the force-velocity relationship changes (force and velocity axis intercepts, slope and estimated maximum power) in response to 5-week training programmes differing in the set configuration. For each session, the traditional group performed 4 sets of 8 repetitions with 5 min of rest between sets and exercises, while the cluster group completed 16 sets of 2 repetitions with 1 min of rest between sets and 5 min between exercises. Both programmes were performed with the 10-repetition maximum load, including bench press, parallel squat, lat pull-down and leg curl exercises. Individual force-velocity profiles were obtained for bench press and squat using a linear velocity transducer before and after the intervention, along with lactate and mechanical performance during the intervention. Results showed in bench press similar changes of the force-velocity profile after both protocols (no shift of the slope and higher force and velocity axis intercept values). For the squat, significant changes in the slope (P = 0.001) and the velocity intercept (P = 0.002) towards a velocity profile were observed after cluster but not after traditional training. These results suggest that set configuration may modulate changes of force-velocity relationship, especially for squat.",2020,"Individual force-velocity profiles were obtained for bench press and squat using a linear velocity transducer before and after the intervention, along with lactate and mechanical performance during the intervention.",[],[],"['velocity intercept', 'velocity profile', 'force-velocity profile']",[],[],"[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",,0.0200481,"Individual force-velocity profiles were obtained for bench press and squat using a linear velocity transducer before and after the intervention, along with lactate and mechanical performance during the intervention.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rial-Vázquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group , A Coruña, Spain.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Mayo', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group , A Coruña, Spain.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University , Prague, Czech Republic.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fariñas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group , A Coruña, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Rúa-Alonso', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group , A Coruña, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sports Sciences and Physical Education, University of A Coruna, Performance and Health Group , A Coruña, Spain.'}]",Sports biomechanics,['10.1080/14763141.2020.1718197'] 1872,32140719,Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study.,"BACKGROUND In animal models cis-palmitoleic acid (9-hexadecenoic acid; 16:1n-7c), a lipokine, improves insulin sensitivity, inflammation, and lipoprotein profiles; in humans trans-palmitoleic acid (16:1n-7t) has been associated with lower incidence of type 2 diabetes. The response to dose-escalation of supplements containing cis- and trans-palmitoleic acid has not been evaluated. OBJECTIVES We examined dose-escalation effects of oral supplementation with seabuckthorn oil and seabuckthorn oil augmented in 16:1n-7t on serum phospholipid fatty acids (PLFAs). METHODS Thirteen participants (7 women and 6 men; age 48 ± 16 y, BMI 30.4 ± 3.7 kg/m2) participated in a randomized, double-blind, crossover, dose-escalation trial of unmodified seabuckthorn oils relatively high in 16:1n-7c (380, 760, and 1520 mg 16:1n-7c/d) and seabuckthorn oils augmented in 16:1n-7t (120, 240, and 480 mg 16:1n-7t/d). Each of the 3 escalation doses was provided for 3 wk, with a 4-wk washout period between the 2 supplements. At the end of each dose period, fasting blood samples were used to determine the primary outcomes (serum concentrations of the PLFAs 16:1n-7t and 16:1n-7c) and the secondary outcomes (glucose homeostasis, serum lipids, and clinical measures). Trends across doses were evaluated using linear regression. RESULTS Compared with baseline, supplementation with seabuckthorn oil augmented in 16:1n-7t increased phospholipid 16:1n-7t by 26.6% at the highest dose (P = 0.0343). Supplementation with unmodified seabuckthorn oil resulted in a positive trend across the dose-escalations (P-trend = 0.0199). No significant effects of either supplement were identified on blood glucose, insulin, lipids, or other clinical measures, although this dosing study was not powered to detect such effects. No carryover or adverse effects were observed. CONCLUSIONS Supplementation with seabuckthorn oil augmented in 16:1n-7t and unmodified seabuckthorn oil moderately increased concentrations of their corresponding PLFAs in metabolically healthy adults, supporting the use of supplementation with these fatty acids to test potential clinical effects in humans.This trial was registered at clinicaltrials.gov as NCT02311790.",2020,"No carryover or adverse effects were observed. ","['Metabolically Healthy Adults', 'metabolically healthy adults', 'Thirteen participants (7 women and 6 men; age 48\xa0±\xa016']","['seabuckthorn oils', 'unmodified seabuckthorn oil', 'oral supplementation with seabuckthorn oil and seabuckthorn oil', 'unmodified seabuckthorn oils', 'seabuckthorn oil', 'Seabuckthorn Oil', 'supplements containing cis- and trans-palmitoleic acid']","['insulin sensitivity, inflammation, and lipoprotein profiles', 'blood glucose, insulin, lipids, or other clinical measures', 'serum phospholipid fatty acids (PLFAs', 'secondary outcomes (glucose homeostasis, serum lipids, and clinical measures', 'carryover or adverse effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0069966', 'cui_str': 'C16:1n7'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",7.0,0.142098,"No carryover or adverse effects were observed. ","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Huang', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa060'] 1873,31937856,Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,"Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold (visit II nd compared to visit III rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.",2020,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","['prediabetic and vitamin D deficient overweight/obese Asian Indian women', 'Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat', '121 females (aged 20-60 years) with prediabetes and vitamin D deficiency']","['Placebo', 'Vitamin D deficiency', 'vitamin D supplementation', 'Vitamin D Supplementation', 'placebo']","['FBG', 'fasting glucose (IFG', 'subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold', 'normal glucose tolerance', 'hemoglobin A1c', 'glycemic category based on\xa0FBG', 'FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia', 'glycemic profile and body composition', 'fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia', '25(OH']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0943356,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-019-56904-y'] 1874,31619181,"Do ultrathin strut bare-metal stents with passive coating improve efficacy in large coronary arteries? Insights from the randomized, multicenter BASKET-PROVE trials.","BACKGROUND The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest higher rates of symptomatic restenosis in patients receiving the newer generation BMS. We investigated the efficacy of a newer generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0 mm). METHODS All patients randomized to SCC- (n = 761) or UC-BMS (n = 765) in the two BASKET-PROVE trials were included. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST) were also assessed. We used inverse probability weighted proportional hazards Cox regressions adjusting for known confounders. RESULTS Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. The risk for clinically driven TVR was increased om the SCC-BMS group compared to the UC-BMS group (cumulative incidence, 10.6% vs. 8.4%; adjusted relative hazard [HR], 1.49 [95% CI, 1.05-2.10]). No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30-1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83-2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39-3.50]). Differences in strut thickness between the two stents did not explain the association between stent type and clinically driven TVR. CONCLUSIONS In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of clinically driven repeat revascularization compared to the UC-BMS with no signs of an offsetting safety benefit.",2019,"No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30-1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83-2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39-3.50]).","['n\u2009=\u2009761) or', 'patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0\u2009mm', 'patients receiving the newer generation BMS', 'patients requiring stenting of large coronary arteries']","['SCC', 'dual antiplatelet therapy', 'generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS', 'UC-BMS', 'CoCr BMS (UC-BMS', 'new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS']","['safety endpoints', 'non-fatal MI', 'strut thickness', 'cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST', 'cardiac death', 'risk for clinically driven TVR', 'symptomatic restenosis', 'clinically driven target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0074523', 'cui_str': 'silicon carbide'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0556614', 'cui_str': 'Thinners (substance)'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",765.0,0.0890265,"No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30-1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83-2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39-3.50]).","[{'ForeName': 'Kim Wadt', 'Initials': 'KW', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, University Hospital Bispebjerg and Frederiksberg, DK-2400, Copenhagen, NV, Denmark. kim.wadt.hansen@regionh.dk.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Sørensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pfisterer', 'Affiliation': 'Department of Cardiology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Louise Hougesen', 'Initials': 'LH', 'LastName': 'Bjerking', 'Affiliation': 'Department of Cardiology, University Hospital Bispebjerg and Frederiksberg, DK-2400, Copenhagen, NV, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Galatius', 'Affiliation': 'Department of Cardiology, University Hospital Bispebjerg and Frederiksberg, DK-2400, Copenhagen, NV, Denmark.'}]",BMC cardiovascular disorders,['10.1186/s12872-019-1199-8'] 1875,6164789,Evaluation of CEA in patients with known residual disease after resection of colonic cancer.,"Serial carcinoembryonic antigen (CEA) levels were measured in 43 patients following incomplete excision of colorectal cancer. Twenty-seven patients received chemotherapy. In the majority the subsequent elevation of CEA could be related to clinical progression, but some patients receiving chemotherapy may have a suppressed rate of CEA rise and may have a more prolonged survival.The clinical application of serial CEA estimations remains of dubious value. However, one area which may be worthy of study is to determine whether suppression of the CEA slope by chemotherapy is attended by clinical control and an improved survival.",1980,Serial carcinoembryonic antigen (CEA) levels were measured in 43 patients following incomplete excision of colorectal cancer.,"['patients with known residual disease after resection of colonic cancer', '43 patients following incomplete excision of colorectal cancer']","['CEA', 'chemotherapy']",['Serial carcinoembryonic antigen (CEA) levels'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",43.0,0.0394672,Serial carcinoembryonic antigen (CEA) levels were measured in 43 patients following incomplete excision of colorectal cancer.,"[{'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Lawton', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Giles', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Cooper', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1876,32179181,Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear taken - A randomised controlled trial.,,2020,,['cervical cancer screening'],[],[],"[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],[],,0.0359161,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Peeters', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cornet', 'Affiliation': 'De Groet, General Practice Oetingen, Gooik, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Devroey', 'Affiliation': 'General Medicine, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arbyn', 'Affiliation': 'Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium. Electronic address: marc.arbyn@sciensano.be.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100194'] 1877,32163431,Preliminary Efficacy of a Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence: A Randomized Clinical Trial.,"TRIAL REGISTRATION This trial was registered with ClinicalTrials.gov, NCT02603471.",2020,"This trial was registered with ClinicalTrials.gov, NCT02603471.",[],['Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence'],[],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],,0.399739,"This trial was registered with ClinicalTrials.gov, NCT02603471.","[{'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Chokron Garneau', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ang', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Mansfield, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0229557'] 1878,32493359,Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.,"BACKGROUND Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing SG and RYGB has been performed in adolescents. OBJECTIVE Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity. METHODS A multicenter randomized controlled non-inferiority trial. Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex) will be included. Adolescents agreeing to participate will be randomized to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at 3 years postoperatively. Secondary outcomes include (i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition. Follow-up will extend into the long term. RESULTS Not applicable. DISCUSSION This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity. TRIAL REGISTRATION The trial is registered at the Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020).",2020,"OBJECTIVE Determine whether SG is non-inferior to RYGB in terms of total body weight","['Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020', 'adolescents', 'adolescents with severe obesity following unsuccessful non-surgical treatments', 'teenagers with severe obesity - TEEN-BEST', 'Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex', 'adolescents with severe obesity']","['Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB', 'RYGB or SG', 'SG and RYGB', 'bariatric surgery', 'Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy', 'SG']","['proportion of participants achieving 20% TBW loss', 'total body weight', 'TBW) loss', 'i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition']","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0335730', 'cui_str': 'Tanner'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",264.0,0.176438,"OBJECTIVE Determine whether SG is non-inferior to RYGB in terms of total body weight","[{'ForeName': 'Daniëlle S', 'Initials': 'DS', 'LastName': 'Bonouvrie', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands. danielle.bonouvrie@mmc.nl.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Department of Gastrosurgical Research and Education - Institute of Clinical Sciences, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Wouter K G', 'Initials': 'WKG', 'LastName': 'Leclercq', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}, {'ForeName': 'Edgar G A H', 'Initials': 'EGAH', 'LastName': 'van Mil', 'Affiliation': ""Department of Pediatrics - Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Arijan A P M', 'Initials': 'AAPM', 'LastName': 'Luijten', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Anita C E', 'Initials': 'ACE', 'LastName': 'Vreugdenhil', 'Affiliation': 'Department of Pediatrics, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Olbers', 'Affiliation': 'Department of Biomedical and Clinical Sciences and Wallenberg Center for Molecular Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'François M H', 'Initials': 'FMH', 'LastName': 'van Dielen', 'Affiliation': 'Obesity Center Máxima - Máxima Medical Center, Eindhoven/Veldhoven, The Netherlands.'}]",BMC surgery,['10.1186/s12893-020-00778-9'] 1879,32493387,Multi-ingredient pre-workout supplementation changes energy system contribution and improves performance during high-intensity intermittent exercise in physically active individuals: a double-blind and placebo controlled study.,"BACKGROUND Nutritional ergogenic aids are commonly used to boost physiological adaptations to exercise and promote greater fitness gains. However, there is a paucity of data about multi-ingredient pre-workout supplementation (MIPS). Therefore, the aim of the present study was to investigate the acute effects of MIPS on the oxidative, glycolytic and ATP-CP energy systems contribution, time spent above 90% V̇O 2max (T90% V̇O 2max ), excess post-exercise oxygen consumption (EPOC) magnitude, number of efforts and time to exhaustion during a high-intensity interval exercise (HIIE) session. METHODS Twelve physically-active and healthy men completed the HIIE sessions that involved running bouts of 15 s on the treadmill at 120% of the maximum aerobic speed (MAS), interspersed with 15 s of passive recovery. Blood lactate was collected at immediately post, 3, 5, and 7 min post exercise. The contribution of ATP-CP, glycolytic and oxidative systems was analyzed at rest, during the HIIE sessions and for 20 min post. Performance variables (time to exhaustion, number of efforts) and oxygen consumption were also analyzed. RESULTS MIPS significantly increased the number of efforts performed (MIPS: 41 ± 10 vs Placebo: 36 ± 12, p = 0.0220) and time to exhaustion (MIPS: 20.1 ± 6 min vs Placebo: 17 ± 5 min, p = 0.0226). There was no difference between supplements for both T90% V̇O 2max (p = 0.9705) and EPOC (p = 0.4930). Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo. There was only a non-significant tendency for a higher glycolytic system contribution after MIPS ingestion (p = 0.0683). CONCLUSION Acute MIPS ingestion appears effective at increasing both aerobic and anaerobic alactic energy contribution and time to exhaustion during a HIIE protocol.",2020,Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo.,"['physically active individuals', 'Twelve physically-active and healthy men']","['MIPS', 'Placebo', 'HIIE sessions that involved running bouts of 15\u2009s on the treadmill at 120% of the maximum aerobic speed (MAS), interspersed with 15\u2009s of passive recovery', 'placebo']","['Blood lactate', 'absolute oxidative energy system contribution', 'oxidative, glycolytic and ATP-CP energy systems contribution, time spent above 90% V̇O 2max (T90% V̇O 2max ), excess post-exercise oxygen consumption (EPOC', 'Performance variables (time to exhaustion, number of efforts) and oxygen consumption', 'absolute ATP-CP contribution', 'magnitude, number of efforts and time to exhaustion']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0280558', 'cui_str': 'COPE regimen'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",12.0,0.210464,Consuming MIPS significantly increased the absolute oxidative energy system contribution by 23.8% (p = 0.0163) and the absolute ATP-CP contribution by 28.4% (p = 0.0055) compared to placebo.,"[{'ForeName': 'Caique', 'Initials': 'C', 'LastName': 'Figueiredo', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Fábio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Fabricio Eduardo', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Immunometabolism of Skeletal Muscle and Exercise Research Group, Department of Physical Education and Associate Graduate Program in Health Science, Federal University of Piauí (UFPI), Teresina, PI, Brazil.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Billaut', 'Affiliation': 'Department of Kinesiology, Laval University, Laval, Quebec, QC, Canada.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Loschi', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Padilha', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, School of Technology and Sciences, Presidente Prudente, São Paulo, Brazil; Post Graduation Program in Physical Therapy, São Paulo State University (UNESP), São Paulo, Brazil. camilapersonal@yahoo.com.br.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00357-6'] 1880,32493335,Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial.,"BACKGROUND The EXAMINE trial tested the efficacy and safety of alogliptin, an inhibitor of dipeptidyl peptidase 4, compared with placebo in 5380 patients with type 2 diabetes and a recent acute coronary syndrome. Because alogliptin is cleared by the kidney, patients were stratified according to screening renal function within two independently randomized strata: (1) estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m 2 and (2) eGFR < 60 ml/min/1.73m 2 . We aim to assess the efficacy and safety of alogliptin vs. placebo according to the renal function strata. METHODS Cox-proportional hazard models with an interaction term by renal function strata were used. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke. RESULTS Patient characteristics were balanced within each renal function strata. In total, 3946 patients were randomized within the eGFR ≥ 60 stratum, and 1434 patients within the eGFR < 60 stratum. The effect of alogliptin was modified by the renal function strata. PRIMARY OUTCOME eGFR ≥ 60 HR = 0.81, 95%CI, 0.65-0.99, and eGFR < 60 HR = 1.20, 95%CI, 0.95-1.53; interaction p  = 0.014. Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p  = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p  = 0.013. CONCLUSIONS Alogliptin may benefit patients with eGFR ≥ 60, but may be detrimental to patients with eGFR < 60 ml/min/1.73m 2 . These hypothesis-generating findings require further validation to assess the potential benefit and risk of alogliptin across the renal function spectrum among patients with type 2 diabetes and a recent acute coronary syndrome. TRIAL REGISTRATION ClinicalTrials.gov, NCT00968708.",2020,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p  = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p  = 0.013. ","['5380 patients with type 2 diabetes and a recent acute coronary syndrome', '3946 patients were randomized within the eGFR ≥\u200960 stratum, and 1434 patients within the eGFR <\u200960 stratum', 'patients with type 2 diabetes and a recent acute coronary syndrome', 'patients with type 2 diabetes']","['alogliptin', 'eGFR', 'alogliptin vs. placebo', 'Alogliptin', 'placebo']","['efficacy and safety', 'composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'glomerular filtration rate (eGFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",5380.0,0.140347,"Cardiovascular death: eGFR ≥ 60 HR = 0.61, 95%CI, 0.42-0.88, and eGFR < 60 HR = 1.16, 95%CI, 0.82-1.65; interaction p  = 0.013. Non-fatal MI: eGFR ≥ 60 HR = 0.86, 95%CI, 0.66-1.13, and eGFR < 60 HR = 1.48, 95%CI, 1.07-2.06; interaction p  = 0.013. ","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Cytel Corportation, Cambridge, MA, USA.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.""}]",BMC medicine,['10.1186/s12916-020-01616-8'] 1881,6122738,Ranitidine and duodenal ulceration: a short-term and maintenance study.,"Forty-eight patients successfully completed a six-week, double blind, placebo controlled trial of ranitidine hydrochloride 200mg twice daily for active duodenal ulceration. Following endoscopy 68% of the patients taking ranitidine had healed, compared to 35% of those who were taking placebo. Nineteen of the patients who had not healed then took a further six weeks of open active treatment; of these, 14 were successfully treated. Thirty-one of the patients who had healed duodenal ulcers then took ranitidine hydrochloride 100mg at night as a maintenance treatment for one year: 71% remained endoscopically and symptomatically in remission. No serious side effects were encountered.",1982,"Following endoscopy 68% of the patients taking ranitidine had healed, compared to 35% of those who were taking placebo.","['Nineteen of the patients who had not healed then took a further six weeks of open active treatment; of these, 14 were successfully treated']","['ranitidine', 'ranitidine hydrochloride', 'placebo', 'Ranitidine']","['healed duodenal ulcers', 'duodenal ulceration']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0700466', 'cui_str': 'Ranitidine Hydrochloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0013295', 'cui_str': 'Duodenal Ulcer'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}]",,0.0434351,"Following endoscopy 68% of the patients taking ranitidine had healed, compared to 35% of those who were taking placebo.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sheers', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 1882,32493344,"Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial.","BACKGROUND Endothelial Progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Cellular mechanisms of DPP4 inhibitors such as linagliptin (LG) on CVD risk, in patients with T2DM with established CKD has not been established. Linagliptin, a DPP4 inhibitor when added to insulin, metformin or both may improve endothelial dysfunction in a diabetic kidney disease (DKD) population. METHODS 31 subjects taking metformin and/or Insulin were enrolled in this 12 weeks, double blind, randomized placebo matched trial, with 5 mg LG compared to placebo. Type 2 diabetes subjects (30-70 years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included. CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition were measured. Data were collected at week 0, 6 and 12. A mixed model regression analysis was done with p value < 0.05 considered significant. RESULTS A double positive CD34/CD184 cell count had a statistically significant increase (p < 0.02) as determined by flow cytometry in LG group where CD184 is SDF1a cell surface receptor. Though mRNA differences in CD34+ve was more pronounced CD34- cell mRNA analysis showed increase in antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3). Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group. A reduction in LDL: HDL ratio was noted in treatment group (p < 0.04). Urinary exosome protein examining podocyte health (podocalyxin, Wilms tumor and nephrin) showed reduction or improvement. CONCLUSIONS In DKD subjects, Linagliptin promotes an increase in CXCR4 expression on CD34 + progenitor cells with a concomitant improvement in vascular and renal parameters at 12 weeks. Trial Registration Number NCT02467478 Date of Registration: 06/08/2015.",2020,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"['patients with T2DM with established CKD', 'Type 2 diabetes subjects (30-70\xa0years old), HbA1c of 6.5-10%, CKD Stage 1-3 were included', '31 subjects taking', 'type 2 diabetes subjects with chronic kidney disease taking']","['Linagliptin', 'linagliptin (LG', 'metformin', 'Endothelial Progenitor cells (EPCs', 'metformin and/or insulin', 'placebo']","['Arterial stiffness measures such as augmentation Index (AI', 'LDL: HDL ratio', 'endothelial dysfunction', 'CXCR4 expression', 'CD34+ cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, biochemistry, resting energy expenditure and body composition', 'pulse wave analysis (PWV', 'antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and prominent endothelial markers (PECAM1, VEGF-A, vWF and NOS3', 'CD34+ve endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C2316401', 'cui_str': 'Chronic kidney disease stage 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.207918,Arterial stiffness measures such as augmentation Index (AI) (p < 0.04) and pulse wave analysis (PWV) were improved (reduced in stiffness) in LG group.,"[{'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Cleyton C', 'Initials': 'CC', 'LastName': 'Domingues', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Fiona J', 'Initials': 'FJ', 'LastName': 'Dore', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Neeki', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Safai', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 I St NW, SMHS Room 462, Washington, DC, 20052, USA.'}, {'ForeName': 'Magan', 'Initials': 'M', 'LastName': 'Fosso', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, 2300 M Street NW, Washington, DC, 20037, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01046-z'] 1883,32493372,Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial.,"BACKGROUND Several neuraxial techniques have demonstrated effective post-cesarean section analgesia. According to previous reports, it is likely that patient-controlled epidural analgesia (PCEA) without opioids is inferior to intrathecal morphine (IM) alone for post-cesarean section analgesia. However, little is known whether adding PCEA to IM is effective or not. The aim of this study was to compare post-cesarean section analgesia between IM with PCEA and IM alone. METHODS Fifty patients undergoing elective cesarean section were enrolled in this prospective randomized study. Patients were randomized to one of two groups: IM group and IM + PCEA group. All patients received spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine, 10 μg of fentanyl, and 150 μg of morphine. Patients in IM + PCEA group received epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine infusion rate of 6 mL/h, bolus dose of 3 mL in lockout interval of 30 min) was commenced at the end of surgery. A numerical rating scale (NRS) at rest and on movement at 4,8,12,24,48 h after the intrathecal administration of morphine were recorded. In addition, we recorded the incidence of delayed ambulation and the number of patients who requested rescue analgesics. We examined NRS using Bonferroni's multiple comparison test following repeated measures analysis of variance; p < 0.05 was considered as statistically significant. RESULTS Twenty-three patients in each group were finally analyzed. Mean NRS at rest was significantly higher in IM group than in IM + PCEA group at 4 (2.7 vs 0.6), 8 (2.2 vs 0.6), and 12 h (2.5 vs 0.7), and NRS during mobilization was significantly higher in IM group than in IM + PCEA group at 4 (4.9 vs 1.5), 8 (4.8 vs 1.9), 12 (4.9 vs 2), and 24 h (5.7 vs 3.5). The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group. No significant difference was observed between the groups in incidence of delayed ambulation. CONCLUSIONS The combined use of PCEA with IM provided better post-cesarean section analgesia compared to IM alone. TRIAL REGISTRATION UMIN-CTR (Registration No. UMIN000032475). Registered 6 May 2018 - Retrospectively registered.",2020,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"['Fifty patients undergoing elective cesarean section', 'post-cesarean section analgesia']","['PCEA and IM alone', 'PCEA', 'IM group and IM\u2009+\u2009PCEA', 'morphine', 'intrathecal morphine alone', 'epidural catheterization through Th11-12 or Th12-L1 before spinal anesthesia and PCEA (basal 0.167% levobupivacaine', 'intrathecal morphine', 'IM\u2009+\u2009PCEA', 'spinal anesthesia with 12\u2009mg of 0.5% hyperbaric bupivacaine']","['numerical rating scale (NRS', 'Mean NRS at rest', 'incidence of delayed ambulation', 'NRS during mobilization', 'delayed ambulation and the number of patients who requested rescue analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",50.0,0.0935582,The number of patients who required rescue analgesics during the first 24 h was significantly higher in IM group compared to IM + PCEA group.,"[{'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan. iwasakih@asahikawa-med.ac.jp.'}, {'ForeName': 'Sarah Kyuragi', 'Initials': 'SK', 'LastName': 'Luthe', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kanda', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan.'}]",BMC anesthesiology,['10.1186/s12871-020-01050-6'] 1884,32493383,MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial.,"INTRODUCTION In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC). We aim to assess the non-inferiority of YEARS compared to current guidelines to rule out PE among PERC-positive ED patients with suspicion of PE. METHODS/DESIGN The MODIGLIANI study is a multicenter, European, non-inferiority, cluster-randomized, two periods cross-over, controlled trial. Each center will be randomized for the sequence of two 4-month periods: intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1 month of ""wash-out"" between the two periods. In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients). In the MODS period, the threshold of D-dimers to rule out PE will be raised to 1000 ng/ml if no item of the YEARS score is present or will remain unchanged otherwise. Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability. ETHICS AND DISSEMINATION The study has received the following approvals: Comité de protection des personnes Ile de France XI (France) and Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona (Spain). Results will be made available to all included participants and other researchers. TRIAL REGISTRATION ClinicalTrials.gov, NCT04032769. Registered on 24 July 2019.",2020,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","['Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability', 'PERC-positive ED patients with suspicion of PE', 'patients aged 50 years or younger and age ×\u200910 for older patients']","['YEARS', 'intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1\u2009month of ""wash-out"" between the two periods']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]",[],,0.159928,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","[{'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Philippon', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Dumont', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jimenez', 'Affiliation': 'Emergency Department, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salhi', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Cachanado', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'Sorbonne Université, Paris, France.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Yonathan', 'Initials': 'Y', 'LastName': 'Freund', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France. yonathanfreund@gmail.com.'}]",Trials,['10.1186/s13063-020-04379-y'] 1885,31287046,Persistent Hotspots in Schistosomiasis Consortium for Operational Research and Evaluation Studies for Gaining and Sustaining Control of Schistosomiasis after Four Years of Mass Drug Administration of Praziquantel.,"Control of schistosomiasis presently relies largely on preventive chemotherapy with praziquantel through mass drug administration (MDA) programs. The Schistosomiasis Consortium for Operational Research and Evaluation has concluded five studies in four countries (Côte d'Ivoire, Kenya, Mozambique, and Tanzania) to evaluate alternative approaches to MDA. Studies involved four intervention years, with final evaluation in the fifth year. Mass drug administration given annually or twice over 4 years reduced average prevalence and intensity of schistosome infections, but not all villages that were treated in the same way responded similarly. There are multiple ways by which responsiveness to MDA, or the lack thereof, could be measured. In the analyses presented here, we defined persistent hotspots (PHS) as villages that achieved less than 35% reduction in prevalence and/or less than 50% reduction in infection intensity after 4 years of either school-based or community-wide MDA, either annually or twice in 4 years. By this definition, at least 30% of villages in each of the five studies were PHSs. We found no consistent relationship between PHSs and the type or frequency of intervention, adequacy of reported MDA coverage, and prevalence or intensity of infection at baseline. New research is warranted to identify PHSs after just one or a few rounds of MDA, and new adaptive strategies need to be advanced and validated for turning PHSs into responder villages.",2019,"Mass drug administration given annually or twice over 4 years reduced average prevalence and intensity of schistosome infections, but not all villages that were treated in the same way responded similarly.",[],['Praziquantel'],"['average prevalence and intensity of schistosome infections', 'infection intensity']",[],"[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036315', 'cui_str': 'Bilharzia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0692036,"Mass drug administration given annually or twice over 4 years reduced average prevalence and intensity of schistosome infections, but not all villages that were treated in the same way responded similarly.","[{'ForeName': 'Nupur', 'Initials': 'N', 'LastName': 'Kittur', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation (SCORE), Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Campbell', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation (SCORE), Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'National Institute for Medical Research, Mwanza Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Pauline N M', 'Initials': 'PNM', 'LastName': 'Mwinzi', 'Affiliation': 'Center for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Diana M S', 'Initials': 'DMS', 'LastName': 'Karanja', 'Affiliation': 'Neglected Tropical Diseases Branch, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Eliezer K', 'Initials': 'EK', 'LastName': ""N'Goran"", 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Phillips', 'Affiliation': 'Department of Infectious Disease Epidemiology, London Centre for Neglected Tropical Disease Research, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Pedro H', 'Initials': 'PH', 'LastName': 'Gazzinelli-Guimaraes', 'Affiliation': 'Department of Infectious Disease Epidemiology, Schistosomiasis Control Initiative, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Section for Parasitology and Aquatic Pathobiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Magnussen', 'Affiliation': 'Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Secor', 'Affiliation': 'Parasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Montgomery', 'Affiliation': 'Parasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Juerg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Walker', 'Affiliation': 'Odum School of Ecology, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Binder', 'Affiliation': 'Schistosomiasis Consortium for Operational Research and Evaluation (SCORE), Center for Tropical and Emerging Global Diseases, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Colley', 'Affiliation': 'Department of Microbiology, University of Georgia, Athens, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0193'] 1886,32192407,Ablation of the great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy: Double-blinded prospective study.,"OBJECTIVES F-care (endovenous radiofrequency, F Care Systems, Antwerp, Belgium) is a relatively new radiofrequency ablation technique for the treatment of venous insufficiency. There is a lack of published data about F-care in literature. This study aimed to prospectively compare the F-care method with conventional endovenous radiofrequency ablation Closurefast method for the management of incompetent great saphenous veins. METHODS Between June 2015 and December 2018, 114 patients with incompetent varicose veins were treated either with the F-care or Closurefast. The pre-, intra-, postprocedural, and follow-up data of the patients were collected and prospectively compared. RESULTS The average ablated vein length was 23.1 ± 4 cm in the F-care group and 26.6 ± 4 cm in the Closurefast group ( P  =   0.01). The average procedure time was 17.4 ± 4 min (range: 10-30 min) in the F-care group, and 17.1 ± 3 min (range: 11-27 min) in the Closurefast group ( P  =   0.77). The one-month total occlusion rates in the F-care and Closurefast groups were 96.2% and 98.1%, respectively ( P  =   0.5). The one-year full occlusion rates in the F-care and Closurefast groups were 71.7% and 90.6%, respectively ( P  =   0.013). In both the F-care and Closurefast groups, the venous clinical severity scores declined significantly with no difference between groups. There was no significant difference between adverse events following F-care treatment compared with Closurefast treatment ( P  ≤   0.05). CONCLUSIONS The F-care system was as safe and fast, but the one-year closure rate was significantly lower when compared to the other method. There was no significant difference between the adverse effects of both approaches. Further large-scale, multi-center prospective studies with long-term outcomes are required to identify the effectiveness of F-care treatment modality for patients with saphenous vein insufficiency.",2020,,[],['great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy'],[],[],"[{'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}]",[],,0.0709942,,"[{'ForeName': 'Macit', 'Initials': 'M', 'LastName': 'Bitargil', 'Affiliation': 'Department of Cardiovascular Surgery, Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Helin E', 'Initials': 'HE', 'LastName': 'Kılıç', 'Affiliation': 'Department of Cardiovascular Surgery, Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.'}]",Phlebology,['10.1177/0268355520913389'] 1887,32493401,Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan.,"BACKGROUND The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease. An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks. METHODS/DESIGN The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end on 30 June 2020. The primary outcome measure of the trial is the urinary albumin excretion level measured at 48 weeks of treatment. This statistical analysis plan presents an update to the published trial protocol and provides a comprehensive description of the statistical methods that will be used for the analysis of the data from this trial. In doing so, we follow the ""Guidelines for the content of statistical analysis plans in clinical trials"" to support transparency and reproducibility of the trial findings. DISCUSSION With the use of this prior statistical analysis plan, we aim to minimise bias in the reporting of the findings of this trial, which evaluates the investigational medicinal product GKT137831. The results of the trial are expected to be published in 2022. TRIAL REGISTRATION ANZCTR registry: ACTRN12617001187336. Registered on 14 July 2017. Universal Trial Number: U1111-1187-2609; Protocol number: T1DGKT137831; Genkyotex trial number: GSN000241.",2020,"BACKGROUND The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","['adults with type 1 diabetes and persistently elevated urinary albumin excretion', 'adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48\u2009weeks']","['GKT13783', 'placebo']","['efficacy and safety', 'urinary albumin excretion level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.413203,"BACKGROUND The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","[{'ForeName': 'Alysha M', 'Initials': 'AM', 'LastName': 'De Livera', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia. alyshad@unimelb.edu.au.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Reutens', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jandeleit-Dahm', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Salim', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}]",Trials,['10.1186/s13063-020-04404-0'] 1888,32493407,"A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol.","BACKGROUND Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd. METHODS/DESIGN REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months. DISCUSSION It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. TRIAL REGISTRATION Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.",2020,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","['Acute otitis media (AOM', 'Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered', 'children with AOMd', 'acute otitis media with discharge in children', '175 GP practices across the United Kingdom (UK', '399 patients from 175 practices in the UK', 'children, with around 2.8 million cases presenting to primary care in England and Wales annually', '399 children aged (≥\u200912\u2009months and\u2009<\u200916\u2009years) presenting to their GP with AOMd']","['amoxicillin (clarithromycin', 'ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin', 'immediate topically administered or delayed orally administered antibiotics', 'ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin', 'antibiotics']","['time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ', 'cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3853088', 'cui_str': 'Moderately bad'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",399.0,0.285734,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Curtis', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University Of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vasa', 'Initials': 'V', 'LastName': 'Curcin', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vibhore', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schilder', 'Affiliation': 'evidENT, UCL Ear Institute, Royal National Throat, Nose and Ear Hospital, 330 Grays Inn Road, London, WC1X 8DA, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sciences Complex, City Campus, Chester Road, Sunderland, SR1 3SD, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK. j.taylor@bristol.ac.uk.'}]",Trials,['10.1186/s13063-020-04419-7'] 1889,32493398,CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins.,"BACKGROUND Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins. METHODS/DESIGN This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period. DISCUSSION This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins. TRIAL REGISTRATION Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.",2020,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.",['incompetent saphenous veins'],"['CASS (CyanoAcrylate closure versus Surgical Stripping', 'cyanoacrylate', 'Endovenous thermal ablation', 'cyanoacrylate closure group or the surgical-stripping group', 'cyanoacrylate closure and surgical stripping', 'cyanoacrylate closure', 'cyanoacrylate closure with the VenaSeal™ closure system', 'ligation and stripping of the saphenous vein', 'surgical stripping']","['absence of venous reflux or residual venous tissue after surgical stripping', 'perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates', 'complete closure rate of the target vein']","[{'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0643514', 'cui_str': '6-chloropenicillanic acid S-sulfoxide'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0618221,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.","[{'ForeName': 'Sungsin', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyung Sub', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Taeseung', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Byun', 'Affiliation': 'Department of Surgery, Wonkwang University Hospital, Wonkwang University School of Medicine, Iksan, South Korea.'}, {'ForeName': 'Woo-Sung', 'Initials': 'WS', 'LastName': 'Yun', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Shin-Seok', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyangkyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University Hospital, Chung-Ang School of Medicine, Dongjak-gu, South Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jin Hyun', 'Initials': 'JH', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'In Mok', 'Initials': 'IM', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, 07061 20 Boramae-ro, Dongjak-gu, Seoul, South Korea. sboy5240@gmail.com.'}]",Trials,['10.1186/s13063-020-04393-0'] 1890,32493411,Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial.,"BACKGROUND Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP). METHODS/DESIGN This study is a randomized, sham-controlled, patient- and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist. CONCLUSION This study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress. TRIAL REGISTRATION Chinese Clinical Trial Registry, ID: ChiCTR1800017581. Registered on 5 August 2018. URL: http://www.chictr.org.cn.",2020,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"['postmenopausal osteoporosis (PMOP', 'postmenopausal women', 'osteoporotic postmenopausal women', 'women with PMOP', '104 women aged 45-70\u2009years with a diagnosis of PMOP']","['acupuncture', 'acupuncture (OA', 'real herbal medicine treatment', 'OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping', 'Acupuncture', 'OA group and the sham acupuncture (SA', 'OA versus SA', 'OA']","['bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1333633', 'cui_str': 'FOXO3A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",104.0,0.305839,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Ren', 'Affiliation': 'Nanjing University of Chinese Medicine, No.138 Xianlin Road, Nanjing, 210046, China.'}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Ao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture, Kunming Municipal Hospital of Traditional Chinese Medicine, 25 Dongfeng Road, Panlong District, Kunming, 650011, Yunnan Province, China.'}, {'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Lai', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Yunnan University of Chinese Medicine, No.120 Guanghua Road, Wuhua District, Kunming, 650032, Yunnan Province, China. kmzhaorong@qq.com.'}]",Trials,['10.1186/s13063-020-04435-7'] 1891,32224318,Perspectives on the model-based approach to proton therapy trials: A retrospective study of a lung cancer randomized trial.,"PURPOSE The goal of this study was to assess whether a model-based approach applied retrospectively to a completed randomized controlled trial (RCT) would have significantly altered the selection of patients of the original trial, using the same selection criteria and endpoint for testing the potential clinical benefit of protons compared to photons. METHODS AND MATERIALS A model-based approach, based on three widely used normal tissue complication probability (NTCP) models for radiation pneumonitis (RP), was applied retrospectively to a completed non-small cell lung cancer RCT (NCT00915005). It was assumed that patients were selected by the model-based approach if their expected ΔNTCP value was above a threshold of 5%. The endpoint chosen matched that of the original trial, the first occurrence of severe (grade ≥3) RP. RESULTS Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for lung cancer using RP as the normal tissue endpoint. The analyzed lung trial showed that less than 19% (32/165) of patients enrolled in the completed trial would have been enrolled in a model-based trial, prescribing photon therapy to all other patients. The number of patients enrolled was also found to be dependent on the type of NTCP model used for evaluating RP, with the three models enrolling 3%, 13% or 19% of patients. This result does show limitations in NTCP models which would affect the success of a model-based trial approach. No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. CONCLUSIONS Uncertainties in the outcome models to predict NTCP are the inherent drawback of a model-based approach to clinical trials. The impact of these uncertainties on enrollment in model-based trials depends on the predicted difference between the two treatment arms and on the set threshold for patient stratification. Our analysis demonstrates that NTCP differences between proton and photon therapy treatments may be too small to support a model-based trial approach for specific treatment sites, such as lung cancer, depending on the chosen normal tissue endpoint.",2020,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ",[],[],[],[],[],[],,0.0324994,"No conclusion regarding the development of RP in patients randomized by the model-based approach could statistically be made. ","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA. Electronic address: amcnamara2@mgh.harvard.edu.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Shusharina', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ajdari', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Paganetti', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.02.022'] 1892,32493447,Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals TRIAL DESIGN: Single centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trial PARTICIPANTS: Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency. INTERVENTION AND COMPARATOR Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical. CONTROL GROUP placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran). MAIN OUTCOMES Confirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose. RANDOMISATION The randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a block size of six. Allocation to the two treatment groups will be conducted by this researcher using paper labels (random 10-digit codes) in a 1:1 ratio t The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according to the randomization list. BLINDING (MASKING) Participants and caregivers are blinded to group assignment and the data will be analyzed by an independent statistical expert who is unaware of the treatment allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the placebo control group TRIAL STATUS: The protocol version number is 99-1-101-47091 and the approval ID is IR.TUMS.VCR.REC.1399.001 and recruitment began April 7, 2020, and is anticipated to be complete by August 7, 2020. TRIAL REGISTRATION The name of the trial register is Iranian registry of clinical trial (IRCT), registration number is IRCT20120826010664N6, date of trial registration is April 7, 2020, FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","['282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the', 'healthcare professionals', ' Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study']","['GROUP\n\n\nplacebo', 'hydroxychloroquine', 'hydroxychloroquine with placebo', 'placebo control', 'Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical', 'placebo']",['COVID-19 virus infection using Polymerase chain reaction (PCR) test'],"[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",282.0,0.426417,"Single centre, 2-arm, double-blind randomised (ratio 1:1)","[{'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Pirjani', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. pirjani@razi.tums.ac.ir.""}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Soori', 'Affiliation': 'Department of Infectious Diseases, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Reza', 'Initials': 'AR', 'LastName': 'Dehpour', 'Affiliation': 'Department of Pharmacology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Department of Obstetrics and Gynecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Arshia', 'Initials': 'A', 'LastName': 'Shizarpour', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh Mohammad', 'Initials': 'RM', 'LastName': 'Jafari', 'Affiliation': 'Experimental Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04439-3'] 1893,32493441,Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome. TRIAL DESIGN A phase 3 prospective, multi-center, interventional, open label, 6-arm 2x2 factorial design study. PARTICIPANTS Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals. Only adult (≥18y old) patients will be recruited with recent (≤16 days) COVID-19 infection and acute hypoxia (defined as PaO2/FiO2 below 350mmHg or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation) and signs of systemic cytokine release syndrome characterized by high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those, who have not been on mechanical ventilation for more than 24 hours before randomisation. Patients should have had a chest X-ray and/or CT scan showing bilateral infiltrates within the last 2 days before randomisation. Patients with active bacterial or fungal infection will be excluded. INTERVENTION AND COMPARATOR Patients will be randomized to 1 of 5 experimental arms versus usual care. The experimental arms consist of Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab in addition to standard care. Patients treated with Anakinra will receive a daily subcutaneous injection of 100mg for a maximum of 28 days or until hospital discharge, whichever comes first. Siltuximab (11mg/kg) or Tocilizumab (8mg/kg, with a maximum dose of 800mg) are administered as a single intravenous injection immediately after randomization. MAIN OUTCOMES The primary end point is the time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death. This ordinal scale is composed of (1) Death; (2) Hospitalized, on invasive mechanical ventilation or ECMO; (3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized. RANDOMISATION Patients will be randomized using an Interactive Web Response System (REDCap). A 2x2 factorial design was selected with a 2:1 randomization regarding the IL-1 blockade (Anakinra) and a 1:2 randomization regarding the IL-6 blockade (Siltuximab and Tocilizumab). BLINDING (MASKING) In this open-label trial neither participants, caregivers, nor those assessing the outcomes are blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive Siltuximab alone, 76 patients will receive Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab. TRIAL STATUS COV-AID protocol version 3.0 (15 Apr 2020). Participant recruitment is ongoing and started on April 4 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment. TRIAL REGISTRATION The trial was registered on Clinical Trials.gov on April 1st, 2020 (ClinicalTrials.gov Identifier: NCT04330638) and on EudraCT on April 3rd 2020 (Identifier: 2020-001500-41). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients with active bacterial or fungal infection will be excluded', 'severely ill COVID-19 patients with anti-interleukin drugs (COV-AID', '342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive', '3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized', 'on April 3rd 2020 (Identifier: 2020-001500-41', 'Only adult (≥18y old) patients will be recruited with recent (≤16 days', 'patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome', 'Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals']","['Interactive Web Response System (REDCap', 'Siltuximab alone', 'EudraCT', 'Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab', 'Tocilizumab', 'individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care', 'Siltuximab', 'invasive mechanical ventilation or ECMO', 'IL-6 blockade (Siltuximab and Tocilizumab', 'Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab']","['time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death', 'COVID-19 infection and acute hypoxia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1609931', 'cui_str': 'siltuximab'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",342.0,0.275166,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04453-5'] 1894,32493434,Community-based program to increase use of hearing conservation practices among farm and rural youth: a cluster randomized trial of effectiveness.,"BACKGROUND Noise exposure and associated hearing loss affects an estimated 2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors. Risk factors for farm youth include frequent exposure to high farm noise; farm work from an early age, and exposure to high recreational noise (e.g., firearms, ATVs, and personal listening devices). METHODS This study compared the effectiveness of two interventions and control. The programs included a community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control (Group C). The study used a cluster randomized control design, with equal allocation ratio to each cluster, without blinding. Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling. A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N = 662 in 13 sites (Group A), N = 680 in 12 sites (Group B), and N = 637 in 11 sites (Group C). RESULTS Comparison with pre-intervention data showed no difference in intent to use hearing conservation strategies in experimental groups. However, knowledge and attitudes toward hearing conservation were improved in the groups receiving the Internet-based booster. Participants reported frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices). CONCLUSIONS It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth. The program was adopted by the partner agency for dissemination to up to 100,000 youth annually. Results of this study inform future intervention studies, interventions aimed at farm youth, and interventions to increase use of hearing conservation strategies, as well as offer a base for developing programs for non-English speaking children. TRIAL REGISTRATION Clinicaltrials.gov registration CT02472821. Date of trial registration: 06/09/2015 (retrospectively registered).",2020,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"['hearing conservation practices among farm and rural youth', 'A total of 1979 youth were enrolled at 36 sites distributed across the 3 study arms in the following distribution: N\xa0=\u2009662 in 13 sites (Group A), N\xa0=\u2009680 in 12 sites (Group B), and N\xa0', '2 million farm youth who are exposed as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, and farm visitors', 'Inclusion criteria included enrollment in grade 4, parental consent, English speaking, and attending a community-based educational event included in the cluster sampling']","['Community-based program', 'community-based interactive youth educational program alone (Group A), a community-based interactive youth educational program followed by an Internet-based booster (Group B), and a no-interaction control']","['knowledge and attitudes toward hearing conservation', 'frequent exposure to sources of hazardous noise (e.g., loud sporting events, firecrackers, personal listening devices']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0336696', 'cui_str': 'Firecracker'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0391096,It is feasible and acceptable to incorporate hearing health education into an already existing system designed to deliver health and safety educational programming to farm and rural youth.,"[{'ForeName': 'Marjorie C', 'Initials': 'MC', 'LastName': 'McCullagh', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA. mcculla@umich.edu.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cohen', 'Affiliation': 'School of Nursing, University of Michigan, 400 North Ingalls Street, Ann Arbor, MI, 48109-5482, USA.'}]",BMC public health,['10.1186/s12889-020-08972-3'] 1895,32228143,Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial.,"INTRODUCTION Early in-home care is increasingly being used in Scandinavian countries for clinically stable premature infants. Due to challenges with travel and hospital resources, alternative ways to support parents during early in-home care are being considered. The aim of this study was to test whether the proportion of mothers exclusively breastfeeding, parental confidence and mother-infant interaction increased after early in-home care with premature infants, and to compare the outcomes of in-home care involving the use of video communication and a mobile application with those of in-home care involving in-hospital consultations. METHODS This study was conducted in four neonatal wards offering premature infant in-home care in Denmark. Premature infants were randomised using 1:1 block randomisation. During early in-home care, families had planned consultations two to three times a week, during which they received support from nurses: the intervention group had video consultations, while the control group had in-hospital consultations. RESULTS The proportion of exclusively breastfeeding mothers at discharge was 66.7% in the intervention group vs 66% in the control group and decreased to 49.4% vs 55%, respectively, 1 month after discharge. No significant improvements were found in the intervention group compared with the control group. In the intervention group, some video consultations were changed to telephone consultations due to problems with the video function, or to in-hospital consultations due to infants' requirement for medical services. No significant differences in secondary outcomes were observed. DISCUSSION The study showed similar breastfeeding proportions at discharge. No unfavourable effects of video consultation compared with in-hospital consultation were found, indicating that video consultation could be a viable option and an important supplement during early in-home care. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT02581800.",2020,,['premature infants and their families'],[],[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],[],,0.0407363,,"[{'ForeName': 'Mai-Britt', 'Initials': 'MB', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Paediatrics, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Ram B', 'Initials': 'RB', 'LastName': 'Dessau', 'Affiliation': 'Department of Clinical Microbiology, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Norlyk', 'Affiliation': 'Department of Public Health, Faculty of Health, Aarhus University, 8000 Aarhus, Denmark.'}, {'ForeName': 'Hristo', 'Initials': 'H', 'LastName': 'Stanchev', 'Affiliation': 'Department of Paediatrics, Slagelse Hospital, 4200 Slagelse, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Kronborg', 'Affiliation': 'Department of Public Health, Faculty of Health, Aarhus University, 8000 Aarhus, Denmark.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20913411'] 1896,32493459,Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial.,"OBJECTIVES Objective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS. HYPOTHESIS Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties. TRIAL DESIGN Pilot, parallel design randomised controlled trial. PARTICIPANTS The trial will recruit 24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia. INTERVENTION AND COMPARATOR Intervention: Intravenous injection of expanded umbilical cord blood cells at a dose of 5 million cells/kg (maximum dose - 500 million cells). Cell infusion will occur over 30-60 minutes through a peripheral intravenous cannula. Standard supportive care will continue as needed. Comparator: Standard supportive care. MAIN OUTCOMES Safety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale. RANDOMISATION Randomisation will be done using computer generated allocation to intervention/ control groups in a 1:1 ratio (in blocks of 6) using sealed opaque envelopes. BLINDING (MASKING) This will be an unblinded study, given that it is the first study using expanded cord blood cells in COVID-19 patients. There will be no placebo infusion. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Twelve participants in each group. Total n=24. TRIAL STATUS CBC-19 protocol v2, dated 23 rd April 2020. Recruitment has not started yet. Estimated recruitment timeline is between 1st July - 31st December 2020. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ACTRN12620000478910, registered 16th April 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"HYPOTHESIS Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties. ","['Total n=24', 'COVID-19 patients', 'adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS', '24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia', 'CBC-19 protocol v2, dated 23 rd April 2020']","['umbilical cord blood derived cell therapy', 'Umbilical cord blood therapy', 'Comparator', 'Intravenous injection of expanded umbilical cord blood cells']",['Safety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",24.0,0.481327,"HYPOTHESIS Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties. ","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': ""Monash Children's Hospital, Melbourne, Australia. atul.malhotra@monash.edu.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ernest', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haylock', 'Affiliation': 'Kabeth Consulting, Melbourne, Australia.'}, {'ForeName': 'Ashalyn', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': 'Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Moeneclaey', 'Affiliation': 'Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jenkin', 'Affiliation': 'Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.'}]",Trials,['10.1186/s13063-020-04387-y'] 1897,31410475,"Exploring the Specificity, Synergy, and Durability of Auditory and Visual Computer Gameplay Transfer Effects in Healthy Older Adults.","OBJECTIVES To determine whether auditory and visual computer games yield transfer effects that (a) are modality-specific to verbal memory (auditory stimulus presentation) and visual-processing tests, (b) affect working memory and processing speed, (c) are synergistic for combined game-type play, and (d) are durable. METHOD A Pilot Study (N = 44) assessed visual transfer effects in a two-group pre-post design. The Main Study (N = 151) employed a 2 (visual games: yes, no) × 2 (auditory games: yes, no) × 3 (test session: pretest, post-test, follow-up) design, allowing different training groups to act as active controls for each other. Neuropsychological test scores were aggregated into verbal-memory (auditory presentation), visual-processing, working-memory, and processing-speed indexes. RESULTS Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups. Visual training yielded modality-specific transfer effects in both samples, transfer to working memory in the main sample, and transfer to processing speed in the pilot sample. There were no comparable transfer effects for auditory training. Combined-visual-and-auditory training failed to yield synergistic effects or any significant transfer effects. Visual-processing transfer effects remained significant at follow-up. DISCUSSION Visual and auditory games differentially modulated transfer effects. Domain-specific visual transfer effects were found at post-test and were durable at follow-up. Visual gameplay holds potential to ameliorate age-related cognitive decline in visual cognition.",2020,"RESULTS Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups.",['Healthy Older Adults'],"['2 (visual games: yes, no) x 2 (auditory games: yes, no', 'Combined-visual-and-auditory training']","['verbal-memory (auditory presentation), visual-processing, working-memory, and processing-speed indexes', 'Visual-processing and working-memory pre-post-training change scores', 'Neuropsychological test scores', 'visual transfer effects', 'Visual-processing transfer effects', 'Domain-specific visual transfer effects']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0355473,"RESULTS Visual-processing and working-memory pre-post-training change scores were differentially modulated across the four gameplay groups in the main sample, demonstrating transfer effects differing across both active- and passive-control groups.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Faust', 'Affiliation': 'Department of Psychological Science, University of North Carolina at Charlotte, North Carolina.'}, {'ForeName': 'Kristi S', 'Initials': 'KS', 'LastName': 'Multhaup', 'Affiliation': 'Department of Psychology, Davidson College, North Carolina.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Ong', 'Affiliation': 'Iredell Memorial Hospital, Statesville, North Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Demakis', 'Affiliation': 'Department of Psychological Science, University of North Carolina at Charlotte, North Carolina.'}, {'ForeName': 'Kelly G', 'Initials': 'KG', 'LastName': 'Balz', 'Affiliation': 'Department of Psychology, Davidson College, North Carolina.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz096'] 1898,31410473,Nurse-led care is preferred over GP-led care of gout and improves gout outcomes: results of Nottingham Gout Treatment Trial follow-up study.,"OBJECTIVES To explore patient satisfaction, gout knowledge, medication adherence and flares among participants receiving nurse-led or general practitioner (GP)-led care of gout in the Nottingham Gout Treatment Trial phase-II (NGTT-II). METHODS A total of 438 participants of NGTT-II were sent a questionnaire enquiring about gout knowledge, satisfaction with health-care practitioner, urate-lowering treatment being undertaken, and gout flares ⩾1 year after their final visit. Nurse-led care participants were asked about their preference for receiving gout treatment from either a GP or a nurse. RESULTS Completed questionnaires were returned by 82% of participants. Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0 (0-0) vs 1 (0-3), P < 0.001] than those receiving GP-led care. Of participants receiving nurse-led care, 41-63% indicated preference for receiving gout treatment from a nurse, while only 5-20% indicated preference for receiving treatment from GPs. CONCLUSION The results of this study favour nurse-led care, involving individualized patient education and engagement and a treat-to-target strategy, in terms of patient acceptability, long-term adherence, and flares. Further research is required to evaluate the feasibility of implementing such a model of care in clinical practice.",2020,"Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0","['participants receiving nurse-led or general practitioner (GP)-led care of gout in the Nottingham Gout Treatment Trial phase-II (NGTT-II', '438 participants of NGTT-II were sent a questionnaire enquiring about gout knowledge, satisfaction with health-care practitioner, urate-lowering treatment being undertaken, and gout flares ⩾1 year after their final visit']",[],"['satisfaction with health-care practitioner', 'gout knowledge']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",438.0,0.0840752,"Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fuller', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Jenkins', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez333'] 1899,31411147,Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial.,"BACKGROUND Mobile health (mHealth) apps represent a promising approach for improving health outcomes in patients with chronic illness, but surprisingly few mHealth interventions have investigated the association between user engagement and health outcomes. We aimed to examine the efficacy of a recommended, commercially available gout self-management app for improving self-care behaviors and to assess self-reported user engagement of the app in a sample of adults with gout. OBJECTIVE Our objective was to examine differences in self-reported user engagement between a recommended gout app (treatment group) and a dietary app (active control group) over 2 weeks as well as to examine any differences in self-care behaviors and illness perceptions. METHODS Seventy-two adults with gout were recruited from the community and three primary and secondary clinics. Participants were randomized to use either Gout Central (n=36), a self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan (n=36), an app based on a diet developed for hypertension, for 2 weeks. The user version of the Mobile Application Rating Scale (uMARS, scale: 1 to 5) was used after the 2 weeks to assess self-reported user engagement, which included an open-ended question. Participants also completed a self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise) and illness perceptions (scale: 0-10) at baseline and after the 2-week trial. Independent samples t tests and analysis of covariance were used to examine differences between groups at baseline and postintervention. RESULTS Participants rated the gout app as more engaging (mean difference -0.58, 95% CI -0.96 to -0.21) and more informative (mean difference -0.34, 95% CI -0.67 to -0.01) than the dietary app at the 2-week follow-up. The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up. There were no significant differences in self-care behaviors between the two groups postintervention. The gout app group also demonstrated stronger negative beliefs regarding the impact of gout (mean difference -2.43, 95% CI -3.68 to -1.18), stronger beliefs regarding the severity of symptoms (mean difference -1.97, 95% CI -3.12 to -0.82), and a stronger emotional response to gout (mean difference -2.38, 95% CI -3.85 to -0.90) at follow-up. Participant feedback highlighted the importance of tracking health-related information, customizing to the target group/individual, providing more interactive features, and simplifying information. CONCLUSIONS Participants found the commercially available gout app more engaging. However, these findings did not translate into differences in self-care behaviors. The gout app group also demonstrated stronger negative illness perceptions at the follow-up. Overall, these findings suggest that the development of gout apps would benefit from a user-centered approach with a focus on daily, long-term self-care behaviors as well as modifying illness beliefs. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12617001052325; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373217.",2019,"The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up.","['adults with gout', 'patients with chronic illness', 'Self-Care Behaviors', 'Seventy-two adults with gout were recruited from the community and three primary and secondary clinics']","['self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise', 'Gout Central', 'self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan']","['stronger negative illness perceptions', 'stronger beliefs regarding the severity of symptoms', 'Mobile Application Rating Scale', 'higher knowledge/understanding of gout', 'self-care behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0222045'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",72.0,0.135377,"The gout app group also reported a higher awareness of the importance of gout (mean difference -0.64, 95% CI -1.27 to -0.003) and higher knowledge/understanding of gout (mean difference -0.70, 95% CI -1.30 to -0.09) than the diet app group at follow-up.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kiralee', 'Initials': 'K', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anel', 'Initials': 'A', 'LastName': 'Kieser', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Arroll', 'Affiliation': 'General Practice and Primary Healthcare, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Bone and Joint Research Group, Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/15021'] 1900,32493460,"A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES Entertainment-education (E-E) media can improve behavioral intent toward health-related practices. In the era of COVID-19, millions of people can be reached by E-E media without requiring any physical contact. We have designed a short, wordless, animated video about COVID-19 hygiene practices-such as social distancing and frequent hand washing-that can be rapidly distributed through social media channels to a global audience. The E-E video's effectiveness, however, remains unclear. The study aims to achieve the following objectives. To: 1.Quantify people's interest in watching a short, animated video about COVID-19 hygiene (abbreviated to CoVideo).2.Establish the CoVideo's effectiveness in increasing behavioural intent toward COVID-19 hygiene.3.Establish the CoVideo's effectiveness in improving COVID-19 hygiene knowledge. TRIAL DESIGN The present study is a multi-site, parallel group, randomized controlled trial (RCT) comparing the effectiveness of the CoVideo against an attention placebo control (APC) video or no video. The trial has an intervention arm (CoVideo), placebo arm (APC), and control arm (no video). Nested in each trial arm is a list experiment and questionnaire survey, with the following ordering. Arm 1: the CoVideo, list experiment, and questionnaire survey. Arm 2: the APC video, list experiment, questionnaire survey, and CoVideo. Arm 3: the list experiment, questionnaire survey, and CoVideo. For each list experiment, participants will be randomized to a control or treatment group. The control group will receive a list of five items and the treatment group will receive the same five items plus one item about COVID-19 hygiene. We will use the list experiment to reduce response bias associated with socially desirable answers to COVID-19 questions. The questionnaire survey will include items about the participant's age, sex, country of residence, highest education, and knowledge of COVID-19 spread. After completing the list experiment and questionnaire survey, participants in Arms 2 and 3 will receive the CoVideo to ensure post-trial access to treatment. PARTICIPANTS This will be an online study setting. We will use Prolific Academic (ProA: https://www.prolific.co) to recruit participants and host our study on the Gorilla™ platform (www.gorilla.sc). To be eligible, participants must be between the age of 18 and 59 years (male, female, or other) and have current residence in the United States, the United Kingdom, Germany, Spain, Mexico, or France. Participants will be excluded from the study if they cannot speak English, German, French, or Spanish (since the instructions and survey questions will be available in these 4 languages only). INTERVENTION AND COMPARATOR The intervention is an E-E video about COVID-19 hygiene (CoVideo). Developed by our co-author (MA) for Stanford Medicine, the CoVideo is animated with sound effects, and has no words, speech, or text. The CoVideo shows how the novel coronavirus is spread (airborne, physical contact) and summarizes the public's response to the COVID-19 outbreak. Key components of the CoVideo are the promotion of five hygiene practices: i) social distancing and avoiding group gatherings, ii) frequently washing hands with soap and water or sanitizer, iii) cleaning surfaces at home (e.g., kitchen counters), iv) not sharing eating utensils, and v) avoidance of stockpiling essential goods (such as toilet paper and face masks). The CoVideo, which was designed for universal reach and optimized for release on social media channels, can be viewed at https://www.youtube.com/watch?v=rAj38E7vrS8. The comparators are an APC video (Arm 2) or no video (Arm 3). The APC video is similar in style to the CoVideo; it is also animated with a duration of 2.30 minutes, has sound effects but no words, speech, or text. The video message is about how small choices become actions, which become habits, which become a way of life. It is available at https://www.youtube.com/watch?v=_HEnohs6yYw. Each list experiment will have a control list as the comparator. The control list is needed to measure the prevalence of behavioral intent toward COVID-19 hygiene. MAIN OUTCOMES This study will measure primary and secondary outcomes related to COVID-19 hygiene. By hygiene, we mean the adoption of behaviors or practices that reduce the chances of being infected or spreading COVID-19. As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods. As a secondary outcome, we will measure knowledge about behaviors that can prevent the spread of COVID-19. RANDOMIZATION Using a web-based randomization algorithm, Gorilla will randomly allocate participants to the intervention (CoVideo), placebo (APC), or control (no video) arm (sequence generation) at a 1:1:1 ratio. Within each trial arm, Gorilla will randomly allocate participants at a 1:1 ratio to the control or treatment group. Items in the lists will be randomly ordered to avoid order effects. The presentation order of the list experiments will also be randomized. BLINDING Because ProA handles the interaction between the study investigators and participants, the participants will be completely anonymous to the study investigators. The outcome measures will be self-reported and submitted anonymously. All persons in the study team will be blinded to the group allocation. NUMBERS TO BE RANDOMIZED The Gorilla algorithm will randomize 6,700 participants to each trial arm, giving a total sample size of 20,100. TRIAL STATUS The protocol version number is 1.0 and the date is 18 May 2020. Recruitment is expected to end by 22 June 2020. Thus far, the study investigators have recruited 2,500 participants on ProA. Of these participants, 800 have completed the study on the Gorilla platform. TRIAL REGISTRATION The study and its outcomes were registered at the German Clinical Trials Register (www.drks.de) on May 12 th , 2020, protocol number: #DRKS00021582. The study was registered before any data was collected. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods.","['6,700 participants to each trial arm, giving a total sample size of 20,100', '2,500 participants on ProA. Of these participants, 800 have completed the study on the Gorilla platform', 'participants must be between the age of 18 and 59 years (male, female, or other) and have current residence in the United States, the United Kingdom, Germany, Spain, Mexico, or France']","['placebo (APC), or control (no video) arm (sequence generation', 'CoVideo against an attention placebo control (APC) video or no video', 'placebo arm (APC), and control arm (no video', 'social distancing and avoiding group gatherings, ii) frequently washing hands with soap and water or sanitizer, iii) cleaning surfaces at home (e.g., kitchen counters), iv) not sharing eating utensils, and v) avoidance of stockpiling essential goods (such as toilet paper and face masks']","['behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods', 'good COVID-19 hygiene practices', 'knowledge about behaviors that can prevent the spread of COVID-19']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018090', 'cui_str': 'Gorilla gorilla'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0079260', 'cui_str': 'Eating Utensils'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0700382', 'cui_str': 'Washing hands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0079260', 'cui_str': 'Eating Utensils'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",,0.0892525,"As our primary outcome, we will measure changes in behavioral intent toward five hygiene practices: social distancing, washing hands, cleaning household surfaces, not sharing eating utensils, and not stockpiling essential goods.","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vandormael', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany. alain.vandormael@uni-heidelberg.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Adam', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Greuel', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04449-1'] 1901,32493462,"Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial.","BACKGROUND Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to the stimulated brain area and the type of exercise performed. METHODS/DESIGN This is a double-blind crossover study, organised into two parts: the first is to assess the effects of tDCS on explosive performance (jump task) and the second is to assess the effects on endurance performance (cycling time trial task). Participants, who are recreationally active or athletes (parkour practitioners, cyclists), will receive two active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions over 5 days (part B). Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B). DISCUSSION This study investigates the acute and repeated effects of tDCS on the motor and cognitive performance of healthy subjects. It will try to evaluate if tDCS could be considered as a neuroenhancement technology according to the physical task investigated (endurance versus explosive). TRIAL REGISTRATION ClinicalTrials.gov, NCT03937115. Registered on 3 May 2019; retrospectively registered.",2020,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B). ","['Participants, who are recreationally active or athletes (parkour practitioners, cyclists', 'healthy subjects', 'sports performance for two profiles of athletes (power and endurance']","['Transcranial direct current stimulation (tDCS', 'active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions', 'tDCS', 'transcranial direct current stimulation']",['Motor and cognitive performance'],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],,0.0921396,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B). ","[{'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Grandperrin', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France. ygrandperrin@chu-besancon.fr.""}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Grosprêtre', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Nicolier', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gimenez', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': ""Centre d'Investigation Clinique, INSERM CIC 1431, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Haffen', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Bennabi', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}]",Trials,['10.1186/s13063-020-04412-0'] 1902,31789348,Ergocalciferol improves endothelial vasodilatory and vasoconstrictor function in an in vivo model of mild uraemia.,"Endothelial dysfunction and vitamin D deficiency are prevalent in patients with cardiovascular disease (CVD) and chronic kidney disease (CKD). Both are risk factors for cardiovascular events in patients with CKD. No studies have investigated the effect of nutritional forms of vitamin D on endothelial function in earlier stages of CKD, when vascular endothelium may be more amenable to this therapy. We studied the effect of ergocalciferol in a pre-clinical model of mild uraemia. Male Wistar rats underwent either a 5/6th nephrectomy or sham surgery. Four weeks after the final stage of the surgery, these two groups were randomly allocated to placebo or an oral dose of 1000 iu of ergocalcfierol at day 7 and 2 pre sacrifice. Vascular responses to acetylcholine, Spermine NONOate and phenylephrine were determined in aortic rings. Blood pressure, calcium, phosphate and parathyroid hormone were measured in all groups. Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals. Ergocalciferol improved the contractile response to potassium chloride in uraemic, but not sham animals. All effects occurred independently of changes to calcium, phosphate, parathyroid hormone and systolic blood pressure. There were no differences in endothelium-independent relaxation to Spermine NONOate. In summary, in a model of mild uraemia, ergocalciferol improved vasodilator and vasoconstrictor tone independently of blood pressure and bone mineral parameters suggesting a direct effect of ergocalciferol on the endothelium.",2019,Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals.  ,"['patients with cardiovascular disease (CVD) and chronic kidney disease (CKD', 'Male Wistar rats', 'patients with CKD']","['acetylcholine, Spermine NONOate and phenylephrine', 'nephrectomy or sham surgery', 'placebo', 'Ergocalciferol', 'ergocalciferol', 'vitamin D']","['Blood pressure, calcium, phosphate and parathyroid hormone', 'contractile response', 'calcium, phosphate, parathyroid hormone and systolic blood pressure', 'blood pressure and bone mineral parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034716', 'cui_str': 'Rats, Wistar'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0293944', 'cui_str': 'spermine NONOate'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014696', 'cui_str': 'Calciferols'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.122966,Ergocalciferol significantly improved the endothelium-dependent responses to acetylcholine and overcame the blunting of the contractile response to phenylephrine seen in uraemic animals.  ,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Dreyer', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Kieswich', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Harwood', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Vascular Pharmacology, William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Yaqoob', 'Affiliation': 'William Harvey Research Institute of Queen Mary University, John Vane Science Building, Charterhouse Square Campus, London EC1B 6BQ, U.K.'}]",Bioscience reports,['10.1042/BSR20190711'] 1903,32493502,Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.,"BACKGROUND Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.",2020,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","['hypertensive patients', 'Responders with persistent hypertension', 'hypertensive patients treated in an urban, safety net Emergency Department (Aim 2', 'Emergency Department patient population']","['primary care provider appointment assistance', 'healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no', 'behavioral intervention', 'facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center']","['blood pressure', 'systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0358591,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA. wmeurer@med.umich.edu.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Flood', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Whitfield', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Trimble', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cowdery', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Borgialli', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Montas', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cunningham', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lorraine R', 'Initials': 'LR', 'LastName': 'Buis', 'Affiliation': 'Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli', 'Initials': 'L', 'LastName': 'Skolarus', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}]",Trials,['10.1186/s13063-020-04340-z'] 1904,32493473,"Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial.","OBJECTIVES The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Secondary objectives are to determine the effects of MSCs on important clinical outcomes, as described below. TRIAL DESIGN REALIST COVID 19 is a randomised, placebo-controlled, triple blinded trial. PARTICIPANTS The study will be conducted in Intensive Care Units in hospitals across the United Kingdom. Patients with moderate to severe ARDS as defined by the Berlin definition, receiving invasive mechanical ventilation and with a diagnosis of COVID-19 based on clinical diagnosis or PCR test will be eligible. Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12); Do Not Attempt Resuscitation order in place; treatment withdrawal imminent within 24 hours; prisoners; declined consent; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial. INTERVENTION AND COMPARATOR Intervention: Allogeneic donor CD362 enriched human umbilical cord derived mesenchymal stromal cells (REALIST ORBCEL-C) supplied as sterile, single-use cryopreserved cell suspension of a fixed dose of 400 x10 6 cells in 40ml volume, to be diluted in Plasma-Lyte 148 to a total volume of 200mls for administration. Comparator (placebo): Plasma-Lyte 148 Solution for Infusion (200mls). The cellular product (REALIST ORBCEL-C) was developed and patented by Orbsen Therapeutics. MAIN OUTCOMES The primary safety outcome is the incidence of serious adverse events. The primary efficacy outcome is Oxygenation Index (OI) at day 7. Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality. RANDOMISATION After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen). Randomisation will be stratified by recruitment centre and by vasopressor use and patients will be allocated to REALIST ORBCEL-C or placebo control in a 1:1 ratio. BLINDING (MASKING) The investigator, treating physician, other members of the site research team and participants will be blinded. The cell therapy facility and clinical trials pharmacist will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A sample size of 60 patients with 30 patients randomised to the intervention and 30 to the control group. If possible, recruitment will continue beyond 60 patients to provide more accurate and definitive trial results. The total number of patients recruited will depend on the pandemic and be guided by the data monitoring and ethics committee (DMEC). TRIAL STATUS REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic. This was an open label dose escalation study of REALIST ORBCEL-C in patients with ARDS. The COVID-19 pandemic emerged as REALIST Phase 2 was planned to commence and the investigator team decided to repurpose the Phase 2 trial as a COVID-19 specific trial. This decision was discussed and approved by the Trial Steering Committee (TSC) and DMEC. Submissions were made to the Research Ethics Committee (REC) and MHRA to amend the protocol to a COVID-19 specific patient population and the protocol amendment was accepted by the REC on 27 th March 2020 and MHRA on 30 th March 2020 respectively. Other protocol changes in this amendment included an increase in the time of onset of ARDS from 48 to 72 hours, inclusion of clinical outcomes as secondary outcomes, the provision of an option for telephone consent, an indicative sample size and provision to continue recruitment beyond this indicative sample size. The current protocol in use is version 4.0 23.03.2020 (Additional file 1). Urgent Public Health status was awarded by the NIHR on 2 April 2020 and the trial opened to recruitment and recruited the first participant the same day. At the time of publication the trial was open to recruitment at 5 sites across the UK (Belfast Health and Social Care Trust, King's College London, Guys and St Thomas' Hospital London, Birmingham Heartlands Hospital and the Queen Elizabeth Hospital Birmingham) and 12 patients have been recruited across these sites. Additional sites are planned to open and appropriate approvals for these are being obtained. It is estimated recruitment will continue for 6 months. TRIAL REGISTRATION ClinicalTrials.gov NCT03042143 (Registered 3 Feb 2017). EudraCT 2017-000585-33 (Registered 28 Nov 2017). FULL PROTOCOL The full protocol (version 4.0 23.03.2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality. RANDOMISATION After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","['2017-000585-33', 'Intensive Care Units in hospitals across the United Kingdom', 'Patients with moderate to severe ARDS', '60 patients with 30 patients randomised to the intervention and 30 to the control group', 'REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic', 'Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12', 'patients with ARDS', 'English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial', 'patients with Acute Respiratory Distress Syndrome (ARDS']","['Comparator (placebo', 'Allogeneic donor CD362', 'Stromal Cell Administration in COVID-19 (REALIST-COVID-19', 'EudraCT', 'Mesenchymal Stromal Cells (MSCs', 'placebo']","['time of onset of ARDS', ' OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality', 'incidence of serious adverse events', 'Oxygenation Index (OI']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0150646', 'cui_str': 'Interpreter'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.415432,"Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO 2 /FiO 2 ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality. RANDOMISATION After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust London and School of Immunology and Microbial Sciences, King's College London, London, UK.""}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': ""Research and Development lead in Critical Care, Kings Trauma Centre, King's College London, London, UK.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Tunnicliffe', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silversides', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McGuigan', 'Affiliation': 'Royal Victoria Hospital, Belfast, UK.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'McFerran', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McFarland', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Smythe', 'Affiliation': 'NHS Blood and Transplant Service, London, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'NHS Blood and Transplant Service, London, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Patient and Public Representative, Belfast, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Curley', 'Affiliation': 'Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Laffey', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': ""O'Kane"", 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK. d.f.mcauley@qub.ac.uk.""}]",Trials,['10.1186/s13063-020-04416-w'] 1905,32498328,The Effect of Low-Carbohydrate Diet on Macrovascular and Microvascular Endothelial Function is Not Affected by the Provision of Caloric Restriction in Women with Obesity: A Randomized Study.,"Obesity impairs both macro- and microvascular endothelial function due to decreased bioavailability of nitric oxide. Current evidence on the effect of low-carbohydrate (LC) diet on endothelial function is conflicting and confounded by the provision of caloric restriction (CR). We tested the hypothesis that LC without CR diet, but not LC with CR diet, would improve macro- and microvascular endothelial function in women with obesity. Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM) were randomly assigned to receive either a LC diet (~10% carbohydrate calories) with CR ( n = 12; 500 calorie/day deficit) or a LC diet without CR ( n = 9) and completed the 6-week diet intervention. After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7). On the other hand, following the LC diet intervention, regardless of CR, blocking nitric oxide production decreased microvascular endothelial function, measured by arteriolar flow-induced dilation ( p ≤ 0.02 for both diets) and the magnitude was more than baseline ( p ≤ 0.04). These data suggest improved NO contributions following the intervention. In conclusion, a 6-week LC diet, regardless of CR, may improve microvascular, but not macrovascular endothelial function, via increasing bioavailability of nitric oxide in women with obesity.",2020,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7).","['women with obesity', 'Women with Obesity', 'Twenty-one healthy women with obesity (age: 33 ± 2 years, body mass index: 33.0 ± 0.6 kg/m 2 ; mean ± SEM']","['LC diet without CR ( n = 9) and completed the 6-week diet intervention', 'LC with CR diet', 'Low-Carbohydrate Diet', 'low-carbohydrate (LC) diet', 'LC diet (~10% carbohydrate calories) with CR']","['brachial artery flow-mediated dilation', 'microvascular endothelial function', 'Macrovascular and Microvascular Endothelial Function', 'macro- and microvascular endothelial function', 'macrovascular endothelial function', 'arteriolar flow-induced dilation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",21.0,0.0299143,"After the intervention, macrovascular endothelial function, measured as brachial artery flow-mediated dilation did not change (7.3 ± 0.9% to 8.0 ± 1.1%, p = 0.7).","[{'ForeName': 'Chueh-Lung', 'Initials': 'CL', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ranieri', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Szczurek', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Assem M', 'Initials': 'AM', 'LastName': 'Ellythy', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elokda', 'Affiliation': 'Department of Rehabilitation Sciences, Florida Gulf Coast University, Fort Myers, FL 33965, USA.'}, {'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL 60612, USA.'}]",Nutrients,['10.3390/nu12061649'] 1906,32499552,"Subjective versus objective, polymer bur-based selective carious tissue removal: 1-year interim analysis of a randomized clinical trial.","We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60 S/55 O). The cluster was the child, with eligible molars being treated identically (91 S/86 O). Cavities were prepared and carious tissue on pulpo-proximal walls selectively removed using hand instruments (S), or a self-limiting polymer bur (Polybur P1, Komet). Cavities were restored using glass-hybrid material (Equia Forte, GC). Treatment times and children's satisfaction were recorded. Generalized-linear models (GLM) and multi-level Cox-regression analysis were applied. Initial treatment times were not significantly different between protocols (mean; 95%CI S: 433; 404-462 sec; O: 412; 382-441 sec; p = 0.378/GLM). There was no significant difference in patients' satisfaction (p = 0.164). No pulpal exposures occurred. 113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%). Pulpal complications occurred in 5(6%) O and 2(2.2%) S molars, respectively. Risk of failure was not significantly associated with the removal protocol, age, sex, dental arch or tooth type (p > 0.05/Cox), but was nearly 5-times higher in multi-surface than single-surface restorations (HR: 4.60; 95% CI: 1.70-12.4). Within the limitations of this interim analysis, there was no significant difference in treatment time, satisfaction and risk of failure between O and S.",2020,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"['113 children', '115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60\u2009S/55\u2009O']",['polymer bur-based selective carious tissue removal'],"[""Treatment times and children's satisfaction"", ""patients' satisfaction"", 'Risk of failure', 'Pulpal complications', 'treatment time, satisfaction and risk of failure between O and S']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",115.0,0.0819157,113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%).,"[{'ForeName': 'Marta Gomes', 'Initials': 'MG', 'LastName': 'Marques', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Leandro Augusto', 'Initials': 'LA', 'LastName': 'Hilgert', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Larissa Ribeiro', 'Initials': 'LR', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Karine Medeiros', 'Initials': 'KM', 'LastName': 'Demarchi', 'Affiliation': 'Graduate Program in Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Patrícia Magno', 'Initials': 'PM', 'LastName': 'Dos Santos Matias', 'Affiliation': 'Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ana Paula Dias', 'Initials': 'APD', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Restorative Dental Sciences, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Soraya Coelho', 'Initials': 'SC', 'LastName': 'Leal', 'Affiliation': 'Department of Dentistry, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Paris', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Department of Oral Diagnostics, Digital Health, Health Services Research, Charité- Universitätsmedizin, Berlin, Germany. falk.schwendicke@charite.de.'}]",Scientific reports,['10.1038/s41598-020-66074-x'] 1907,32501276,"Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.","BACKGROUND Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS A moderate decrease was detected in PHQ-9 scores from HLP (β=-3.05; P=.01) and MP (β=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s12888-015-0475-0.",2020,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","['Depression in Primary Care', 'n=56), and MP (n=54', 'March 2015 and March 2016, with a follow-up of 12 months', 'patients with depression', '221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions']","['HLP', 'Three Low-Intensity, Internet-Based Psychological Interventions', 'PAPP intervention', 'iTAU', 'PAPP', '3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP', 'internet-based psychological interventions (HLP and MP']","['physical SF-12 scores', 'Spanish version of the Patient Health Questionnaire-9', 'PHQ-9 scores', 'visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0270456', 'cui_str': 'Moderate major depression'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0263420', 'cui_str': 'Hyperkeratosis lenticularis perstans'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",221.0,0.0776652,"PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression.","[{'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Adoración', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Mayoral-Cleries', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Department of Clinical and Basic Psychology and Biopsychology, Faculty of Health Sciences, Univeristy Jaume I, Castellón, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Barceló-Soler', 'Affiliation': 'Aragón Institute for Health Research (IIS Aragon), Zaragoza, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Hurtado', 'Affiliation': 'Mental Heath Unit, Hospital Regional of Malaga, Biomedicine Research Institute (IBIMA), Málaga, Spain.'}, {'ForeName': 'MªTeresa', 'Initials': 'M', 'LastName': 'Navarro', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Mental Health Unit of Pozoblaco, Hospital Los Pedroches, Córdoba, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Pérez-Ara', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Riera-Serra', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Rosa Mª', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Biomedical Research Center Network (CIBER) Physiopathology Obesity and Nutrition (CIBERobn), Carlos III Health Institute, Madrid, Spain.'}]",Journal of medical Internet research,['10.2196/15845'] 1908,32501339,Senegal to trial $1 speedy test for covid-19.,,2020,,[],[],[],[],[],[],,0.0487405,,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': ''}]",New scientist (1971),['10.1016/S0262-4079(20)30914-3'] 1909,32497553,A randomised controlled trial investigating efficacy of a novel toothpaste containing calcium silicate and sodium phosphate in dentine hypersensitivity pain reduction compared to a fluoride control toothpaste.,"OBJECTIVES To compare a calcium silicate and sodium phosphate toothpaste (CSSP) with a fluoride negative control toothpaste for dentine hypersensitivity (DH) pain reduction after 14, 28 and 29 days. METHODS This was a double blind, parallel study in 247 healthy adults with DH (Schiff score >2, tactile 10-20 g) in 2 teeth in different quadrants of the mouth. After acclimatisation, participants were randomised to CSSP or control toothpaste. After measuring baseline sensitivity products were applied twice-daily by toothbrushing, and once daily massaging into the sensitive teeth. Sensitivity was assessed following airblast (Schiff and VAS) and tactile (Yeaple probe) stimuli at baseline, 14 and 28 days, and at 29 days, 12 h after last product application. Participants completed a quality of life questionnaire at each study visit up to day 28. RESULTS After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001). Quality of life scores improved in both groups, but no significant differences between groups were observed. CONCLUSIONS The CSSP toothpaste was more effective than the fluoride control toothpaste at reducing DH pain with benefit persisting 12 h following application. CLINICAL SIGNIFICANCE This novel calcium silicate and sodium phosphate toothpaste (CSSP) toothpaste is an effective twice-daily treatment when brushed on the teeth for dentine hypersensitivity sufferers compared to brushing with a conventional fluoride paste. Twice-daily brushing provides a sustained effect for long-lasting pain relief from dentine hypersensitivity.",2020,"After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001).","['dentine hypersensitivity (DH) pain reduction after 14, 28 and 29 days', '247 healthy adults with DH (Schiff score >2, tactile 10-20\u2009g) in 2 teeth in different quadrants of the mouth']","['CSSP', 'fluoride negative control toothpaste', 'calcium silicate and sodium phosphate toothpaste (CSSP', 'sodium phosphate toothpaste (CSSP) toothpaste', 'novel toothpaste containing calcium silicate and sodium phosphate', 'fluoride control toothpaste', 'CSSP toothpaste', 'CSSP or control toothpaste']","['airblast (Schiff and VAS) and tactile (Yeaple probe) stimuli', 'Quality of life scores', 'DH pain', 'lower Schiff, lower VAS and higher Yeaple probe scores', 'quality of life questionnaire', 'Sensitivity', 'dentine hypersensitivity pain reduction']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",247.0,0.192859,"After 14, 28 and 29 days the CSSP group had significantly lower Schiff, lower VAS and higher Yeaple probe scores compared to control (VAS at 14 days, p < 0.04; all other comparisons, p < 0.001).","[{'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Newcombe', 'Affiliation': 'Institute of Primary Care & Public Health, Cardiff University, Cardiff, CF10 3AT, UK. Electronic address: newcombe@cardiff.ac.uk.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Matheson', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, CH63 3JU, UK. Electronic address: Jane.Matheson@unilever.com.'}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Weddell', 'Affiliation': 'Unilever Oral Care, Quarry Road East, Bebington, CH63 3JU, UK. Electronic address: Lynnette.Weddell@unilever.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Unilever Oral Care, Unilever House, 100 Victoria Embankment, London, EC4Y 0DY, UK. Electronic address: Mark.Edwards@unilever.com.'}, {'ForeName': 'Nicola X', 'Initials': 'NX', 'LastName': 'West', 'Affiliation': 'Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK. Electronic address: n.x.west@bristol.ac.uk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103320'] 1910,32500094,Impact of Ketorolac on Opioid Consumption after Knee Arthroscopy.,"Purpose The objective of this study was to examine postoperative opioid consumption in outpatients undergoing knee arthroscopy after a single dose of intravenous ketorolac. Methods Patients ages 18-65 years old, weighing over 50kg and scheduled for knee arthroscopy were randomized to one of the four groups of preoperative ketorolac (0mg, 7.5mg, 15mg, 30mg). The primary outcome measured was postoperative opioid consumption. Secondary outcomes included visual analog scale pain scores, patient satisfaction scores, side effects and total postoperative anesthesia care unit time. Equivalency between ketorolac groups in opioid reduction relative to placebo was evaluated for each dose pair (7.5 vs. 15mg, 7.5 vs. 30mg, and 15 vs. 30mg). Linear regression models were used to examine associations between ketorolac dose with postoperative length of stay and patient satisfaction. A linear mixed model was used to evalaute the association between ketorolac dose and pain scores over time. Results A total of 112 patients with comparable patient and procedural characteristics were enrolled. Equivalency in opioid reduction relative to placebo was not demonstrated between any examined ketorlac doses (7.5 vs. 15mg, P = 0.167; 7.5 vs. 30mg, P = 0.451; 15 vs. 30mg, P = 0.515). Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012). Patient satisfaction and postoperative duration did not vary with ketorolac dose. Conclusions Although all ketorolac doses decreased PACU pain scores, equivalency in PACU opioid reduction between ketorolac doses was not demonstrated.",2018,"Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012).","['Methods\n\n\nPatients ages 18-65 years old, weighing over 50kg and scheduled for knee arthroscopy', '112 patients with comparable patient and procedural characteristics were enrolled', 'outpatients undergoing knee arthroscopy after a single dose of intravenous', 'after Knee Arthroscopy']","['Ketorolac', 'preoperative ketorolac', 'ketorolac', 'placebo']","['Opioid Consumption', 'pain scores', 'postoperative pain scores', 'PACU pain scores, equivalency in PACU opioid reduction', 'postoperative opioid consumption', 'Patient satisfaction and postoperative duration', 'visual analog scale pain scores, patient satisfaction scores, side effects and total postoperative anesthesia care unit time']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",112.0,0.115964,"Compared to placebo, all ketorlac doses decreased postoperative pain scores (global P=0.012).","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Wilson', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Slone', 'Affiliation': 'Department of Orthopedics, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Furse', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Epperson', 'Affiliation': 'Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Austin journal of anesthesia and analgesia,[] 1911,32497099,Redesign and validation of a computer programming course using Inductive Teaching Method.,"Inductive Teaching Method (ITM) promotes effective learning in technological education (Felder & Silverman, 1988). Students prefer ITM more as it makes the subject easily understandable (Goltermann, 2011). The ITM motivates the students to actively participate in class activities and therefore could be considered a better approach to teach computer programming. There has been little research on implementing ITM in computer science courses despite its potential to improve effective learning. In this research, an existing computer programming lab course is taught using a traditional Deductive Teaching Method (DTM). The course is redesigned and taught by adopting the ITM instead. Furthermore, a comprehensive plan has been devised to deliver the course content in computer labs. The course was evaluated in an experiment consisting of 81 undergraduate students. The students in the Experimental Group (EG) (N = 45) were taught using the redesigned ITM course, whereas the students in the Control Group (CG) (N = 36) were taught using the DTM course. The performance of both groups was compared in terms of the marks obtained by them. A pre-test conducted to compare pre-course mathematical and analytical abilities showed that CG was better in analytical reasoning with no significant differences in mathematical abilities. Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG. The results of this research could help computer programming educators to implement inductive strategies that could improve the learning of the computer programming.",2020,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.",['81 undergraduate students'],['Inductive Teaching Method (ITM'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]",[],45.0,0.0100507,"Three post-tests were used to evaluate the groups theoretical and practical competence in programming and showed EG improved performance with large, medium, and small effect sizes as compared to CG.","[{'ForeName': 'Iftikhar Ahmed', 'Initials': 'IA', 'LastName': 'Khan', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Iftikhar', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Syed Sajid', 'Initials': 'SS', 'LastName': 'Hussain', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Attiqa', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Nosheen', 'Initials': 'N', 'LastName': 'Gul', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Jadoon', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Nazir', 'Affiliation': 'Department of Computer Science, COMSATS University Islamabad, Abbottabad, Pakistan.'}]",PloS one,['10.1371/journal.pone.0233716'] 1912,32502164,Effect of practice exergames on the mood states and self-esteem of elementary school boys and girls during physical education classes: A cluster-randomized controlled natural experiment.,"Reduced physical exercise can impact children's mental health. Use of active electronic games can help promote psychological health. Physical education (PE class) uses different resources, methods, and contents to promote student health. We investigated the effect of exergames on the mood and self-esteem of children and compare it that of with traditional PE classes. From a sample of 213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years), allocated to an experimental group (EG; n = 68; five clusters) and a PE group (PE; n = 72; five clusters), participated in this experimental controlled study. The EG practiced exergames during three 40-minute classes, and the PE group held three routine curricular PE classes. Brunel's Mood Scale and Rosenberg's Self-Esteem Scale were applied. Repeated measures ANOVA identified differences between sexes and groups. The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05). Regarding sex comparisons, anger was lower in girls (F: 4.57; p <0.05; ES: 0.61; 95% CI: 0.11-1.11) in the EG. Vigor was higher in girls in the EG than in those in the PE group (F: 5.46; p <0.05; ES: 0.56; 95% CI: 0.12-1.01). The main results of the PE group indicated increased self-esteem in boys (p <0.05; ES: 0.58; 95% CI: 0.08-1.07) and reduction of girls' mental confusion (p <0.05; ES 0.58; 95% CI 0.15-1.06). Thus, exergames impact boys' and girls' self-esteem and mood, as well as traditional physical education classes. Further study on exergames in schools is essential, with long-term effects on physical and mental health. Exergames bring interesting, varied content, technology, and innovation that can increase the attractiveness of physical education.",2020,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"['213 children (7-11 years old), 140 from 10 classes of the fourth and fifth grades of elementary school (59 boys, 81 girls; mean age 9.41±0.48 years', 'elementary school boys and girls during physical education classes']","['physical exercise', 'Physical education (PE class', 'practice exergames', 'active electronic games']","[""Brunel's Mood Scale and Rosenberg's Self-Esteem Scale"", 'Vigor', ""reduction of girls' mental confusion"", 'mood states and self-esteem', 'self-esteem']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",213.0,0.0680954,The main results of the EG demonstrated reduced tension in girls (p <0.05; ES: 0.62; 95% CI: 0.17-1.05).,"[{'ForeName': 'Alexandro', 'Initials': 'A', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Whyllerton Mayron da', 'Initials': 'WMD', 'LastName': 'Cruz', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Clara Knierim', 'Initials': 'CK', 'LastName': 'Correia', 'Affiliation': 'Laboratory of Aquatic Biomechanics, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Ana Luiza Goya', 'Initials': 'ALG', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Guilherme Guimarães', 'Initials': 'GG', 'LastName': 'Bevilacqua', 'Affiliation': 'Laboratory of Sport and Exercise Psychology, Santa Catarina State University, Florianópolis, Brazil.'}]",PloS one,['10.1371/journal.pone.0232392'] 1913,32502179,"Efficacy of topical bevacizumab 0.05% eye drops in dry eye disease: A double-masked, randomized trial.","The objective of this double-masked, placebo-controlled, randomized trial was to assess the efficacy and safety of bevacizumab 0.05% eye drops in dry eye patients. This study included Dry Eye Workshop Study (DEWS) Grade 3-4 dry eye participants (n = 31) whose tear break-up time (TBUT) was ≤5 seconds(s). Participants were randomized to undergo treatment with either bevacizumab 0.05% eye drops (n = 19) or placebo (n = 12). The primary outcome was TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade were secondary outcomes. All outcomes were measured at 1-, 4- and 12 weeks. TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001). Moreover, the improvement of TBUT in bevacizumab group versus placebo group at 4- and 12 weeks differed significantly from that difference at baseline (P = 0.002 and P = 0.003, respectively). The proportion of participants achieving increase of 3 seconds or more of TBUT at week 12 in the bevacizumab group was significantly greater than that in the placebo group (P = 0.02). Oxford scheme grade at 1-, 4- and 12 weeks differed significantly from the values at baseline in bevacizumab group (P = 0.001, P = 0.01, and P = 0.03, respectively). OSDI scores at 1-, 4- and 12-week follow-ups were significantly lower than that at baseline in bevacizumab group (P<0.001 at each follow-up). Schirmer test were not significantly different within or between groups (the lowest P = 0.92). No adverse events occurred in this study. Patients treated with bevacizumab 0.05% eye drops showed significant improvement in tear film stability, corneal staining and symptoms.",2020,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"['dry eye patients', 'dry eye disease']","['bevacizumab 0.05% eye drops', 'topical bevacizumab', 'bevacizumab', 'placebo']","['tear film stability, corneal staining and symptoms', 'OSDI scores', 'proportion of participants achieving increase of 3 seconds or more of TBUT', 'efficacy and safety', 'TBUT, and the proportion of responders (increase of ≥3s in TBUT at week 12), ocular surface disease index (OSDI) score, Schirmer test, and Oxford scheme grade', 'adverse events']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",31.0,0.52162,TBUT in bevacizumab group differed significantly from TBUT in placebo group within 12 weeks (P = 0.001).,"[{'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanawat', 'Initials': 'K', 'LastName': 'Chantaralawan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Uthaithammarat', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0234186'] 1914,32502206,Digital versus analogue record systems for mass casualty incidents at sea-Results from an exploratory study.,"OBJECTIVE Mis-triage may have serious consequences for patients in mass casualty incidents (MCI) at sea. The purpose of this study was to assess outcome, reliability and validity of an analogue and a digital recording system for triage of a MCI at sea. METHODS The study based on a triage exercise conducted with a cross-over-design. Forty-eight volunteers were presented a fictional MCI with 50 cases. The volunteers were randomly assigned to start with the analogue (Group A, starting with the analogue followed by the digital system) or digital system (Group B, starting with the digital followed by the analogue system). Triage score distribution and agreement between the triage methods and a predefined standard were reported. Reliability was analysed using Cronbach's Alpha and Cohen's Kappa. Validity was measured through sensitivity, specificity and predictive value. Treatment, period and carry-over-effects were analysed using a linear mixed-effects model. RESULTS The number of patients triaged (total: n = 3545) with the analogue system (n = 1914; 79.75%) was significantly higher (p = 0.001) than with the digital system (n = 1631; 67.96%). A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282). Ratio of under-triage was significantly smaller with the digital system (p = 0.001). Validity measured with Cronbach's Alpha and Cohen's Kappa was higher with the digital system. So was sensitivity (category; green: 80.67%, yellow: 73.24%, red: 83.54%; analogue: green: 93.28%, yellow: 82.36%, red: 94.04%) and specificity of the digital system (green: 78.07%, yellow: 63.75%, red: 66.25%; analogue: green: 85.50%, yellow: 79.88%, red: 91.50%). Comparing the predictive values and accuracy, the digital system showed higher scores than the analogue system. No significant patterns of carry-over-effects were observed. CONCLUSIONS Significant differences were found for the number of triages comparing the analogue and digital recording system. The digital system has a slightly higher reliability and validity than the analogue triage system.",2020,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"['patients in mass casualty incidents (MCI) at sea', 'Forty-eight volunteers were presented a fictional MCI with 50 cases']","['analogue (Group A, starting with the analogue followed by the digital system) or digital system', 'analogue']","['Ratio of under-triage', 'specificity of the digital system ', 'sensitivity, specificity and predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1955957', 'cui_str': 'Mass Casualty Incidents'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",3545.0,0.0347985,A trend towards a higher percentage of correct triages with the digital system was observed (p = 0.282).,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Henning', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Mustafa Sinan', 'Initials': 'MS', 'LastName': 'Bakir', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Lyubomir', 'Initials': 'L', 'LastName': 'Haralambiev', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schulz-Drost', 'Affiliation': 'Department of Trauma Surgery, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hinz', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Institute for Community Medicine, Section Methods in Community Medicine, University Medicine Greifswald, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ekkernkamp', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gümbel', 'Affiliation': 'Department of Trauma, Reconstructive Surgery and Rehabilitation Medicine, University Medicine Greifswald, Greifswald, Germany.'}]",PloS one,['10.1371/journal.pone.0234156'] 1915,32493720,Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials.,"A maternal vaccine capable of boosting neutralizing antibody (NAb) responses directed against circulating viruses in HIV-infected pregnant women could effectively decrease mother-to-child transmission of HIV. However, it is not known if an HIV envelope (Env) vaccine administered to infected pregnant women could enhance autologous virus neutralization and thereby reduce this risk of vertical HIV transmission. Here, we assessed autologous virus NAb responses in maternal plasma samples obtained from AIDS Vaccine Evaluation Group (AVEG) protocols 104 and 102, representing historical phase I safety and immunogenicity trials of recombinant HIV Env subunit vaccines administered to HIV-infected pregnant women (ClinicalTrials registration no. NCT00001041). Maternal HIV Env-specific plasma binding and neutralizing antibody responses were characterized before and after vaccination in 15 AVEG 104 ( n  = 10 vaccine recipients, n  = 5 placebo recipients) and 2 AVEG 102 ( n  = 1 vaccine recipient, n  = 1 placebo recipient) participants. Single-genome amplification (SGA) was used to obtain HIV env gene sequences of autologous maternal viruses for pseudovirus production and neutralization sensitivity testing in pre- and postvaccination plasma of HIV-infected pregnant vaccine recipients ( n  = 6 gp120, n  = 1 gp160) and placebo recipients ( n  = 3). We detected an increase in Env subunit MN gp120-specific IgG binding in the group of vaccine recipients between the first immunization visit and the last visit at delivery ( P  = 0.027, 2-sided Wilcoxon test). While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy. Immunization strategies capable of further enhancing these autologous virus NAb responses in pregnant women will be important to block vertical transmission of HIV. IMPORTANCE Maternal antiretroviral therapy (ART) has effectively reduced but not eliminated the burden of mother-to-child transmission of HIV across the globe, as an estimated 160,000 children were newly infected with HIV in 2018. Thus, additional preventive strategies beyond ART will be required to close the remaining gap and end the pediatric HIV epidemic. A maternal active immunization strategy that synergizes with maternal ART could further reduce infant HIV infections. In this study, we found that two historic HIV Env vaccines did not enhance the ability of HIV-infected pregnant women to neutralize autologous viruses. Therefore, next-generation maternal HIV vaccine candidates must employ alternate approaches to achieve potent neutralizing antibody and perhaps nonneutralizing antibody responses to effectively impede vertical virus transmission. Moreover, these approaches must reflect the broad diversity of HIV strains and widespread availability of ART worldwide.",2020,"While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy.","['160,000 children were newly infected with HIV in 2018', 'HIV-infected pregnant women', 'HIV-infected pregnant women (ClinicalTrials registration no', 'pregnant women']","['Maternal antiretroviral therapy (ART', 'Single-genome amplification (SGA', 'recombinant HIV Env subunit vaccines', 'AVEG 102 ( n \u2009=\u20091 vaccine recipient, n \u2009=\u20091 placebo', 'placebo']","['Env subunit MN gp120-specific IgG binding', 'levels of autologous virus neutralization potency', 'Maternal HIV Env-specific plasma binding and neutralizing antibody responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0887892', 'cui_str': 'Vaccines, Subunit'}, {'cui': 'C0085432', 'cui_str': 'AIDS Vaccines'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0019691', 'cui_str': 'env Protein gp120, HIV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]",160000.0,0.230413,"While no difference was observed in the levels of autologous virus neutralization potency between groups, in both groups maternal plasma collected at delivery more effectively neutralized autologous viruses from early pregnancy than late pregnancy.","[{'ForeName': 'Eliza D', 'Initials': 'ED', 'LastName': 'Hompe', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jesse F', 'Initials': 'JF', 'LastName': 'Mangold', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Eudailey', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'McGuire', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Barton F', 'Initials': 'BF', 'LastName': 'Haynes', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'M Anthony', 'Initials': 'MA', 'LastName': 'Moody', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Wright', 'Affiliation': 'Department of Pediatrics, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Genevieve G', 'Initials': 'GG', 'LastName': 'Fouda', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Elena E', 'Initials': 'EE', 'LastName': 'Giorgi', 'Affiliation': 'Los Alamos National Laboratory, Los Alamos, New Mexico, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Sallie R', 'Initials': 'SR', 'LastName': 'Permar', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA sallie.permar@duke.edu.'}]",mSphere,['10.1128/mSphere.00254-20'] 1916,32498699,"The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol.","INTRODUCTION Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones. METHODS The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation. DISCUSSION The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options. TRIAL REGISTRATION ISRCTN: ISRCTN98970319. Registered on 11 November 2015.",2020,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","['Flank pain from stones (renal colic', 'lower pole kidney stones', 'Patients aged ≥16\u2009years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder\xa0(CTKUB) and requiring treatment for a stone ≤10\u2009mm', 'stones in the lower pole of the kidney']","['percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy', 'ESWL or PCNL', 'FURS or PCNL (RCT2', 'PUrE (PCNL, FURS and ESWL', 'FURS', 'FURS or ESWL (RCT1', 'shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy', 'surgical interventions', 'FURS versus ESWL or PCNL']","['health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire', 'incremental cost per quality-adjusted life year gained at 12\u2009months post-randomisation']","[{'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.185133,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'McClinton', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK. pure@abdn.ac.uk.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Starr', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Anson', 'Affiliation': ""St George's Hospital, London, UK.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'Stone Patient Advisory Group, Section of Endourology, British Association of Urological Surgeons, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'MacLennan', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Daron', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Turney', 'Affiliation': 'Oxford University Hospitals NHS Trust, Headley Way, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Addenbrooke's NHS Trust, Hills Road, Cambridge, UK.""}]",Trials,['10.1186/s13063-020-04326-x'] 1917,32496736,Exercise Training Impacts Skeletal Muscle Clock in Adults with Prediabetes.,"PURPOSE Disruption of the skeletal muscle molecular clock leads to metabolic disease, while exercise may be restorative, leading to improvements in metabolic health. The purpose of this study was to evaluate the effects of a 12-week exercise intervention on skeletal muscle molecular clock machinery in adults with obesity and prediabetes, and determine whether these changes were related to exercise-induced improvements in metabolic health. METHODS Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week exercise intervention and were fully provided isoenergetic diets. Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy) were assessed at baseline and after intervention. Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER 1/2 were measured by quantitative real-time PCR and Western blot, respectively. RESULTS Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max) all improved (P<0.005) with exercise training. Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged. The fold change in BMAL1 correlated with post GDR (r=0.43, P=0.044), BMI (r=-0.44, P=0.042), and body weight changes (r=-0.44, P=0.039) expressed as percent delta. CONCLUSION Exercise training impacts skeletal muscle molecular clock machinery in a clinically-relevant cohort of adults with obesity and prediabetes. Skeletal muscle BMAL1 gene expression may improve insulin sensitivity. Future studies are needed to determine the physiological significance of exercise-induced alterations in skeletal muscle clock machinery.",2020,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","['Twenty-six adults (age: 66 ± 4.5 yrs; BMI: 34 ± 3.4 kg/m, FPG: 105 ± 15 mg/dL) participated in a 12-week', 'adults with obesity and prediabetes', 'Adults with Prediabetes']","['exercise intervention', 'Exercise training', 'Exercise Training', 'exercise intervention and were fully provided isoenergetic diets']","['Body composition (DXA), abdominal adiposity (CT scans), peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp), exercise capacity (VO2max), and skeletal muscle molecular clock machinery (vastus lateralis biopsy', 'Body composition (BMI, DXA, CT), peripheral insulin sensitivity (glucose disposal rate; GDR), and exercise capacity (VO2max', 'Skeletal muscle BMAL1 gene', 'PER2 protein expression', 'BMAL1', 'BMI', 'while CLOCK, CRY1/2 and PER1', 'Gene and protein expression of skeletal muscle BMAL1, CLOCK, CRY1/2, and PER', 'body weight changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0337076', 'cui_str': 'Industrial machine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",26.0,0.0285188,"Skeletal muscle BMAL1 gene (fold change: 1.62 ± 1.01; P=0.027) and PER2 protein expression (fold change: 1.35 ± 0.05; P=0.02) increased, while CLOCK, CRY1/2 and PER1 were unchanged.","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Erickson', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Mey', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002368'] 1918,32497779,"Effects of a synbiotic on symptoms, and daily functioning in attention deficit hyperactivity disorder - A double-blind randomized controlled trial.","Some prebiotics and probiotics have been proposed to improve psychiatric symptoms in children with autism. However, few studies were placebo-controlled, and there is no study on persons with an attention deficit hyperactivity disorder (ADHD) diagnosis. Our aim was to study effects of Synbiotic 2000 on psychiatric symptoms and functioning in children and adults with ADHD without an autism diagnosis. Children and adults (n = 182) with an ADHD diagnosis completed the nine weeks randomized double-blind parallel placebo-controlled trial examining effects of Synbiotic 2000 on the primary endpoints ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16. Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery. Synbiotic 2000 and placebo improved ADHD symptoms equally well, and neither active treatment nor placebo had any statistically significant effect on functioning or sub-diagnostic autism symptoms. However, Synbiotic 2000, specifically, reduced sub-diagnostic autism symptoms in the domain restricted, repetitive and stereotyped behaviors in children, and improved emotion regulation in the domain of goal-directed behavior in adults. In children with elevated sVCAM-1 levels at baseline as well as in children without ADHD medication, Synbiotic 2000 reduced both the total score of autism symptoms, and the restricted, repetitive and stereotyped behaviors. In adults with elevated sVCAM-1 at baseline, Synbiotic 2000 significantly improved emotion regulation, both the total score and four of the five subdomains. To conclude, while no definite Synbiotic 2000-specific effect was detected, the analysis of those with elevated plasma sVCAM-1 levels proposed a reduction of autism symptoms in children and an improvement of emotion regulation in adults with ADHD. Trial registration number: ISRCTN57795429.",2020,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","['children with autism', 'persons with an attention deficit hyperactivity disorder (ADHD) diagnosis', 'children and adults with ADHD without an autism diagnosis', 'Children and adults (n=182) with an ADHD diagnosis', 'Attention deficit hyperactivity disorder ', 'adults with ADHD']","['placebo', 'Synbiotic 2000 and placebo', 'Synbiotic 2000', 'synbiotic']","['psychiatric symptoms and functioning', 'plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses', 'emotion regulation', 'total score of autism symptoms', 'reduced sub-diagnostic autism symptoms', 'elevated sVCAM-1 levels', 'ADHD symptoms, autism symptoms and daily functioning, and the secondary endpoint emotion regulation, measured using the questionnaires SNAP-IV, ASRS, WFIRS, SCQ, AQ and DERS-16', 'ADHD symptoms', 'functioning or sub-diagnostic autism symptoms', 'psychiatric symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1177045', 'cui_str': 'Snap'}]",,0.53757,"Levels at baseline of plasma C-reactive protein and soluble vascular cell adhesion molecule-1 (sVCAM-1), central to leukocyte-endothelial cell adhesion facilitating inflammatory responses in tissues, were measured using Meso Scale Discovery.","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Skott', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Liu L', 'Initials': 'LL', 'LastName': 'Yang', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Stiernborg', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Söderström', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Rȕegg', 'Affiliation': 'Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden; Uppsala University, Department of Organismal Biology, Uppsala, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schalling', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Karolinska Institutet, Department of Global Public Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'MaiBritt', 'Initials': 'M', 'LastName': 'Giacobini', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Lavebratt', 'Affiliation': 'Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm, Sweden; Karolinska University Hospital Solna, Center for Molecular Medicine, Stockholm, Sweden. Electronic address: catharina.lavebratt@ki.se.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.05.056'] 1919,32501914,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population. METHODS Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications. RESULTS The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group. CONCLUSIONS There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients. LEVEL OF EVIDENCE Level I.",2020,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480'] 1920,32501985,Influences of different dose of tirofiban for acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention.,"Tirofiban is widely used in patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). This drug can efficiently improve myocardial perfusion and cardiac function, but its dose still remains controversial. We here investigated the effects of different dose of tirofiban on myocardial reperfusion and heart function in patients with STEMI. A total of 312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018 were enrolled and randomly divided into control group (75 cases, 0 μg/kg), low-dose group (79 cases, 5 μg/kg), medium-dose group (81 cases, 10 μg/kg) and high-dose group (77 cases, 20 μg/kg). The infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution were recorded. At Day 7 and Day 30 after PCI, the left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia were also evaluated. After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05). Moreover, the LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter of high-dose group were significantly improved than those of other groups, and the LVEF of medium-dose group was significantly superior to that of low-dose group (P < .05). However, the incidence of major adverse cardiac events in high-dose group was significantly decreased, while the hemorrhage and incidence of thrombocytopenia of high-dose group were significantly higher than those of other 3 groups (P < .05). The tirofiban can effectively alleviate the myocardial ischemia-reperfusion injury and promote the recovery of cardiac function in STEMI patients underwent PCI. Although the high-dose can enhance the clinical effects, it also increased the hemorrhagic risk. Therefore, the rational dosage application of tirofiban become much indispensable in view of patient's conditions and hemorrhagic risk, and a medium dose of 10 μg/kg may be appropriate for patients without high hemorrhagic risk.",2020,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","['acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention', 'patients without high hemorrhagic risk', 'patients with STEMI', '312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018', 'patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI']","['tirofiban', 'Tirofiban']","['infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution', 'left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia', 'incidence of major adverse cardiac events', 'myocardial perfusion and cardiac function', 'rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution', 'hemorrhage and incidence of thrombocytopenia', 'LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter', 'myocardial reperfusion and heart function', 'hemorrhagic risk']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",312.0,0.0198557,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department Pharmacy, the Second Clinical Hospital of Shanxi Medical University, Taiyuan, Shanxi.'}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'AstraZeneca (Wuxi) trading co. LTD, Wuxi, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000020402'] 1921,32502040,"The research of Tuna Huichun Gong on pulmonary function, exercise tolerance, and quality of life in patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation.","INTRODUCTION Chronic obstructive pulmonary disease (COPD) is a common high-burden and highly disabling lung disease. The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles. Although recommended by the global initiative for chronic obstructive lung disease guidelines, pulmonary rehabilitation (PR) has not been used widely because of its inherent limitations. Tuna-Hui-Chun-Gong (TNHCG) is a popular traditional exercise used to treat COPD in China. We aim to evaluate the safety and efficacy of TNHCG for PR of COPD. METHODS The provided protocol is for a single-blind randomized controlled trial in which 120 COPD patients will be randomly and equally divided into the experimental or control group. The control group will be treated with standard COPD drugs while the experimental group will perform TNHCG exercises apart from standard drug treatment. The duration of treatment will be 24 weeks and a follow-up for 48 weeks. The primary outcome will be the 6-Minute Walk Test. The secondary outcomes will include the pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency. A safety assessment will also be performed during the trial. DISCUSSION Our study will provide evidence to support TNHCG exercise as an additional measure for PR of COPD. TRIAL REGISTRATION ChiCTR1900028332, Registered December 29, 2019. ETHICS AND DISSEMINATION Ethics approval has been granted by the Sichuan Traditional Chinese Medicine Regional Ethics Review Committee (No. 2019KL-050).",2020,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"['Chronic obstructive pulmonary disease (COPD', '120 COPD patients', 'patients with chronic obstructive pulmonary disease based on the concept of early pulmonary rehabilitation', 'patients with COPD', 'Registered December 29, 2019']","['Tuna Huichun Gong', 'Tuna-Hui-Chun-Gong (TNHCG', 'TNHCG', 'TNHCG exercise', 'standard COPD drugs while the experimental group will perform TNHCG exercises']","['pulmonary function, exercise tolerance, and quality of life', '6-Minute Walk Test', 'quality of life and exercise endurance', 'safety and efficacy', ""pulmonary function test, St George's respiratory questionnaire, COPD assessment test, modified medical research council dyspnea scale, Hospital Anxiety and Depression Scale, and exacerbation frequency""]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0041382', 'cui_str': 'Tuna'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",120.0,0.106714,The quality of life and exercise endurance of patients with COPD is often low because of atrophy of the respiratory and skeletal muscles.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Su', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianming', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Respiratory Medicine, AVIC 363 Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020625'] 1922,32502043,A retrospective study of probiotics for the treatment of children with antibiotic-associated diarrhea.,"This retrospective study aimed to explore the benefits and safety of probiotics (live combined Bacillus subtilis and Enterococcus faecium granules with multivitamines) for the treatment of children with antibiotic-associated diarrhea (AAD).A total of 72 children with AAD were analyzed in this study. Of these, 36 children received routine treatment plus probiotics, and were assigned to a treatment group. The other 36 children underwent routine treatment alone, and were assigned to a control group. Patients in both groups were treated for a total of 7 days. The efficacy and safety were evaluated by duration of diarrhea (days), number of dressings needed daily, abdominal pain intensity, stool consistency (as assessed by Bristol Stool Scale (BSS)), and any adverse events.After treatment, probiotics showed encouraging benefits in decreasing duration of diarrhea (days) (P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01). In addition, no adverse events were documented in this study.The findings of this study demonstrated that probiotics may provide promising benefit for children with AAD. Further studies are still needed to warrant theses findings.",2020,"(P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01).","['36 children received', 'children with antibiotic-associated diarrhea (AAD).A total of 72 children with AAD', 'children with AAD', '36 children underwent', 'children with antibiotic-associated diarrhea']","['probiotics (live combined Bacillus subtilis and Enterococcus faecium granules with multivitamines', 'probiotics', 'routine treatment plus probiotics', 'routine treatment alone']","['abdominal pain intensity', 'stool consistency (BSS', 'number of dressings needed every day', 'efficacy and safety', 'adverse events', 'duration of diarrhea (days), number of dressings needed daily, abdominal pain intensity, stool consistency (as assessed by Bristol Stool Scale (BSS)), and any adverse events', 'duration of diarrhea (days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0005129', 'cui_str': 'Bernard Soulier syndrome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",72.0,0.0269625,"(P < .01), number of dressings needed every day (P < .01), abdominal pain intensity (P < .01), and stool consistency (BSS (3-5), P < .01; BSS (6-7), P < .01).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Rui', 'Affiliation': 'Department of Microecology, School of Basic Medical Science, Jiamusi University, Jiamusi, China.'}, {'ForeName': 'Shu-Xia', 'Initials': 'SX', 'LastName': 'Ma', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020631'] 1923,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients. MATERIALS AND METHODS This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery. RESULTS The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05). CONCLUSIONS The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073'] 1924,32502969,Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial.,"BACKGROUND The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. OBJECTIVE The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. METHODS A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. RESULTS This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. CONCLUSIONS At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. TRIAL REGISTRATION Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/16170.",2020,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"['10 individuals using computer-generated random sequence numbers', 'obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake', 'Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants', 'children aged 7 to 12 years']",[],"['diet quality and energy consumption', 'body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference', 'childhood obesity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]",,0.0560747,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"[{'ForeName': 'Joana Maia', 'Initials': 'JM', 'LastName': 'Brandao', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Simone Augusta', 'Initials': 'SA', 'LastName': 'Ribas', 'Affiliation': 'Department of Nutrition and Public Health, School of Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eliseu', 'Initials': 'E', 'LastName': 'Verly-Jr', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosangela Alves', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Inês Rugani Ribeiro De', 'Initials': 'IRR', 'LastName': 'Castro', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bruna Kulik', 'Initials': 'BK', 'LastName': 'Hassan', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandra Silva Dias De', 'Initials': 'ASD', 'LastName': 'Oliveira', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Emanuele Souza', 'Initials': 'ES', 'LastName': 'Marques', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Diana Barbosa', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",JMIR research protocols,['10.2196/16170'] 1925,32503004,"Effect of exercise training on insulin sensitivity, hyperinsulinemia and ectopic fat in black South African women: a randomized controlled trial.","Objective We investigated the effects of a 12-week exercise intervention on insulin sensitivity (SI) and hyperinsulinemia and associated changes in regional and ectopic fat. Research design and methods Healthy, black South African women with obesity (mean age 23 ± 3.5 years) and of isiXhosa ancestry were randomised into a 12-week aerobic and resistance exercise training group (n = 23) and a no exercise group (control, n = 22). Pre and post-intervention testing included assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI) (frequently sampled i.v. glucose tolerance test); fat mass and regional adiposity (dual-energy X-ray absorptiometry); hepatic, pancreatic and skeletal muscle fat content and abdominal s.c. and visceral adipose tissue volumes (MRI). Results Exercise training increased VO2peak (mean ± s.d.: 24.9 ± 2.42 to 27.6 ± 3.39 mL/kg/min, P < 0.001), SI (2.0 (1.2-2.8) to 2.2 (1.5-3.7) (mU/l)-1 min-1, P = 0.005) and DI (median (interquartile range): 6.1 (3.6-7.1) to 6.5 (5.6-9.2) × 103 arbitrary units, P = 0.028), and decreased gynoid fat mass (18.5 ± 1.7 to 18.2 ± 1.6%, P < 0.001) and body weight (84.1 ± 8.7 to 83.3 ± .9.7 kg, P = 0.038). None of these changes were observed in the control group, but body weight increased (P = 0.030). AIRg, ISR and FEL, VAT, SAT and ectopic fat were unaltered after exercise training. The increase in SI and DI were not associated with changes in regional or ectopic fat. Conclusion Exercise training increased SI independent from changes in hyperinsulinemia and ectopic fat, suggesting that ectopic fat might not be a principal determinant of insulin resistance in this cohort.",2020,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","['black South African women', 'Healthy, black South African women with obesity (mean', 'age 23 ± 3.5 years) and of isiXhosa ancestry']","['exercise training', 'Conclusion\n\n\nExercise training', 'no exercise', 'exercise intervention', 'aerobic and resistance exercise training']","['insulin sensitivity (SI) and hyperinsulinemia', 'hyperinsulinemia and ectopic fat', 'body weight', 'AIRg, ISR and FEL, VAT, SAT and ectopic fat', 'insulin sensitivity, hyperinsulinemia and ectopic fat', 'SI', 'SI and DI', 'gynoid fat mass', 'assessment of SI, insulin response to glucose (AIRg), insulin secretion rate (ISR), hepatic insulin extraction (FEL) and disposition index (DI) (AIRg × SI', 'glucose tolerance test); fat mass and regional adiposity']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0272199', 'cui_str': 'Familial hemophagocytic lymphohistiocytosis'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0228643,"None of these changes were observed in the control group, but body weight increased (P = 0.030).","[{'ForeName': 'Melony C', 'Initials': 'MC', 'LastName': 'Fortuin-de Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hauksson', 'Affiliation': 'Department of Radiation Sciences, Radiation Physics and Biomedical Engineering, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olah', 'Initials': 'O', 'LastName': 'Hakim', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Clinical Studies, New Bolton Center, University of Pennsylvania, School of Veterinary Medicine, Kennett Square, Pennsylvania, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lindokuhle', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Swart', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Goff', 'Affiliation': ""Department of Diabetes, School of Life Course Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Micklesfield', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]",European journal of endocrinology,['10.1530/EJE-19-0957'] 1926,32503005,Psychological well-being and personality in relation to weight loss following behavioral modification intervention in obese women with polycystic ovary syndrome: a randomized controlled trial.,"Objective Little is known about how lifestyle affects psychological well-being in overweight women with polycystic ovary syndrome (PCOS). We investigated the effects of behavioral modification on psychological well-being and the impact of well-being and personality traits on successful weight loss. Design A 4-month randomized controlled trial with a 12-month follow-up at a University Hospital. Methods Sixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2, were randomized (1:1) into a behavioral modification program (intervention) or minimal intervention (control). The outcome measures were the psychological well being index and the Swedish universities scales of personality. Results At baseline, 60% had a global psychological well being index corresponding to severe distress and 40% to moderate distress. There was no significant change in mean global well-being score at 4 months within or between groups. However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033). Anxiety and general health tended to differ between groups (P = .06, respectively) favoring intervention. In the whole population, women achieving ≥5% weight loss at 12 months (n = 18) were less anxious at baseline compared to those who had not (P = .004). Personality trait-analysis showed that the weight-loss group had higher social desirability (P = .033) and lower embitterment (P = .023). Conclusions Psychological well-being is severely impacted in overweight women with PCOS. Behavioral modification can positively impact dimensions of well-being, although not fully significant, compared to control treatment. Personality factors could contribute to the understanding of successful weight loss.",2020,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","['obese women with polycystic ovary syndrome', 'overweight women with polycystic ovary syndrome (PCOS', 'Methods\n\n\nSixty-eight women with PCOS, aged 18 to 40 years with a BMI ≥27 kg/m2', 'overweight women with PCOS']","['behavioral modification intervention', 'behavioral modification program (intervention) or minimal intervention (control']","['global psychological well being index corresponding to severe distress', 'anxiety', 'weight loss', 'general health', 'Anxiety and general health', 'mean global well-being score', 'psychological well being index and the Swedish universities scales of personality', 'social desirability']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}]",68.0,0.0840157,"However, after 4 months, the intervention group expressed less anxiety (P = .035), higher general health (P = .012) and lower depressed mood (P = .033).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Oberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Liselott', 'Initials': 'L', 'LastName': 'Blomberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Sebastian B', 'Initials': 'SB', 'LastName': 'Gidlöf', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Petra Tollet', 'Initials': 'PT', 'LastName': 'Egnell', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}]",European journal of endocrinology,['10.1530/EJE-20-0066'] 1927,32503556,"Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan.","BACKGROUND Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. In Afghanistan, where most births take place at home without the assistance of a skilled birth attendant, there is a need for options to manage PPH in community-based settings. Misoprostol, a uterotonic that has been used as prophylaxis at the household level and has also been proven to be effective in treating PPH in hospital settings, is one possible option. METHODS A double-blind, randomized placebo-controlled trial was conducted in six districts in Badakhshan Province, Afghanistan to test the effectiveness and safety of administering 800mcg sublingual misoprostol to women after a home birth for treatment of excessive blood loss. Consenting women were enrolled prior to delivery and given 600mcg misoprostol to self-administer orally as prophylaxis. Community health workers (CHW) were trained to observe for signs of PPH after delivery and if PPH was diagnosed, administer the study medication (misoprostol or placebo) and immediately refer the woman. A hemoglobin (Hb) decline of 2 g/dL or greater, measured pre- and post-delivery, served as the primary outcome; side effects, additional interventions, and transfer rates were also analyzed. RESULTS Among the 1884 women who delivered at home, nearly all (98.7%) reported self-use of misoprostol for PPH prevention. A small fraction was diagnosed with PPH (4.4%, 82/1884) and was administered treatment. Hb outcomes, including the proportion of women with a Hb drop of 2 g/dL or greater, were similar between the study groups (misoprostol: 56.4% (22/39), placebo: 60.6% (20/33), p = 0.45). Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03). Other side effects were similar between study groups and none required treatment, including among the subset of 39 women, who received misoprostol for both of its PPH indications. CONCLUSIONS While the study did not document a clinical benefit associated with misoprostol for treatment of PPH, study findings suggest that use of misoprostol for both prevention and treatment in the same birth as well as its use by lay level providers in home births does not result in any safety concerns. TRIAL REGISTRATION This trial was registered with ClinicalTrials.gov, number NCT01508429 Registered on December 1, 2011.",2020,"Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03).","['Badakhshan province, Afghanistan', 'postpartum hemorrhage', 'to women after a home birth for treatment of excessive blood loss', 'Community health workers (CHW', 'Consenting women were enrolled prior to delivery and given 600mcg', 'six districts in Badakhshan Province, Afghanistan', '1884 women who delivered at home, nearly all (98.7%) reported self-use of']","['medication (misoprostol or placebo', 'Misoprostol', 'misoprostol to self-administer orally as prophylaxis', 'sublingual misoprostol', 'misoprostol', 'placebo']","['proportion of women with a Hb drop of 2\u2009g/dL', 'side effects, additional interventions, and transfer rates', 'A hemoglobin (Hb) decline', 'shivering']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019857', 'cui_str': 'Home birth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}]",,0.667159,"Significantly more women randomized to receive misoprostol experienced shivering (82.5% vs. placebo: 61.5%, p = 0.03).","[{'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Abbas', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}, {'ForeName': 'Shafiq', 'Initials': 'S', 'LastName': 'Mirzazada', 'Affiliation': 'Academic Projects Afghanistan, Aga Khan University, Co French Medical Institute for Children, Ali Abad, Kabul, Afghanistan.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Durocher', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA. jdurocher@gynuity.org.'}, {'ForeName': 'Shahfaqir', 'Initials': 'S', 'LastName': 'Pamiri', 'Affiliation': 'Aga Khan Health Services Afghanistan (AKHS-A), An Agency of the Aga Khan Development Network (AKDN), Baghlan, Afghanistan.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Byrne', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Winikoff', 'Affiliation': 'Gynuity Health Projects, 220 East 42nd Street Suite 710, New York, NY, 10017, USA.'}]",Reproductive health,['10.1186/s12978-020-00933-8'] 1928,32503599,Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial.,"BACKGROUND This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy. METHODS IMPACT was a 52-week, randomized, double-blind, multicenter Phase III study comparing the efficacy and safety of FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC/VI 62.5/25 mcg in patients ≥40 years of age with symptomatic chronic obstructive pulmonary disease (COPD) and ≥1 moderate/severe exacerbation in the previous year. The inclusion criteria for the study were intentionally designed to permit the enrollment of patients with significant concurrent CV disease/risk. CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death. RESULTS Baseline CV risk factors were similar across treatment groups. Overall, 68% of patients (n = 7012) had ≥1 CV risk factor and 40% (n = 4127) had ≥2. At baseline, 29% of patients reported a current/past cardiac disorder and 58% reported a current/past vascular disorder. The proportion of patients with on-treatment CVAESI was 11% for both FF/UMEC/VI and UMEC/VI, and 10% for FF/VI. There was no statistical difference for FF/UMEC/VI versus FF/VI or UMEC/VI in TTF CVAESI (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.85, 1.11; p = 0.711 and HR: 0.92, 95% CI: 0.78, 1.08; p = 0.317, respectively) nor TTF CVAESI leading to hospitalization/prolonged hospitalization or death (HR: 1.19, 95% CI: 0.93, 1.51; p = 0.167 and HR: 0.96, 95% CI: 0.72, 1.27; p = 0.760, respectively). On-treatment MACE occurred in ≤3% of patients across treatment groups, with similar prevalence and rates between treatments. CONCLUSIONS In a symptomatic COPD population with a history of exacerbations and a high rate of CV disease/risk, the proportion of patients with CVAESI and MACE was 10-11% and 1-3%, respectively, across treatment arms, and the risk of CVAESI was low and similar across treatment arms. There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI. TRIAL REGISTRATION NCT02164513 (GSK study number CTT116855).",2020,"There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI. ","['patients with COPD', 'patients ≥40\u2009years of age with symptomatic chronic obstructive pulmonary disease (COPD) and\u2009≥1 moderate/severe exacerbation in the previous year']","['Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol', 'FF/UMEC/VI 100/62.5/25 mcg with FF/VI 100/25 mcg or UMEC', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy']","['cardiovascular (CV) safety', 'CV risk', 'efficacy and safety', 'CV safety assessments included proportion of patients with and exposure-adjusted rates of on-treatment CV adverse events of special interest (CVAESI) and major adverse cardiac events (MACE), as well as time-to-first (TTF) CVAESI, and TTF CVAESI resulting in hospitalization/prolonged hospitalization or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.678148,"There was no statistically significant increased CV risk associated with the use of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI. ","[{'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK. nicola.x.day@gsk.com.'}, {'ForeName': 'Subramanya', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]",Respiratory research,['10.1186/s12931-020-01398-w'] 1929,32503602,Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials.,"OBJECTIVES The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination. TRIAL DESIGN Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment. INTERVENTION AND COMPARATOR For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine. MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. RANDOMISATION Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre. BLINDING (MASKING) Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800). TRIAL STATUS HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing. TRIAL REGISTRATION The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547. FULL PROTOCOL The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","['N=1600 elderly persons randomised to', 'The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547', 'Recruitment began 25-03-2020 and was completed on the 23-04-2020', 'patients with the COVID-19 infection and (2) elderly ≥60 years', 'HCW: version 4.0, 24-04-2020', 'health care workers and hospital admission by elderly persons during the COVID-19 pandemic']","['Bacillus Calmette-Guérin Vaccination', 'BCG vaccine', 'BCG vaccine or placebo', 'placebo']","['cumulative incidence of hospital admission', '1) Number of days of unplanned work absenteeism in HCWs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.395304,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Ten Doesschate', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands. t.tendoesschate@umcutrecht.nl.'}, {'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'van der Vaart', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Taks', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Debisarun', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Ten Oever', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Patricia Bruijning', 'Initials': 'PB', 'LastName': 'Verhagen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Arief', 'Initials': 'A', 'LastName': 'Lalmohamed', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ter Heine', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Axel B', 'Initials': 'AB', 'LastName': 'Janssen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04389-w'] 1930,32503606,Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics.,"BACKGROUND Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal breast cancer for every 5 kg/m 2 increase in body mass index (BMI). Despite this evidence there are few lifestyle programmes directed towards breast cancer risk reduction. This paper describes the process of optimising of the ActWELL programme which aims to support weight management in women invited to attend routine National Health Service (NHS) breast screening clinics. METHODS A feasibility study of a prototype programme aiming to change lifestyle behaviours was successfully undertaken. The programme used educational approaches and behaviour change techniques delivered by lifestyle coaches using individual face to face meetings and telephone sessions. To optimise the intervention for a definitive randomised controlled trial of weight management, data from the feasibility trial, focus group discussions conducted with the target population, feedback from the trial public advisory group and comments from peer reviewers were obtained. Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group. RESULTS The results from the feasibility trial were considered appropriate for moving on to a full trial with 70% of participants finding the programme acceptable. The primary outcomes (weight loss and physical activity) provided an important focus for design input from the target group. The contributions highlighted the need to review programme duration, coach contact time, content and use of behaviour change techniques and communications generally (e.g. science and evidence, non-judgemental approaches and avoiding guilt). In addition, the need for emphasis on support rather than education became apparent. The recommendations from peer reviewers focussed on the magnitude of effort required to achieve the intended weight loss and weight loss maintenance. Implementation science supported the use of the capability/opportunity/motivation (COM-B)model in overall design. CONCLUSIONS The optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women. TRIAL REGISTRATION ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.",2020,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group. ","['women attending routine NHS breast screening clinics', 'women invited to attend routine National Health Service (NHS) breast screening clinics', 'post-menopausal women']","['lifestyle intervention programme', 'prototype programme']","['weight loss and physical activity', 'body mass index (BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0584181,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group. ","[{'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.s.anderson@dundee.ac.uk.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'McAdam', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Macaskill', 'Affiliation': 'Department of Breast Surgery, NHS Tayside, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McKell', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Stead', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}]",Trials,['10.1186/s13063-020-04405-z'] 1931,32505126,Striatal activation to monetary reward is associated with alcohol reward sensitivity.,"One well-known phenotypic risk factor for the development of alcohol use disorder is sensitivity to the rewarding effects of alcohol. In the present study, we examined whether individuals who are sensitive to alcohol reward are also sensitive to nondrug rewards, thereby reflecting a broader individual difference risk factor. Specifically, we tested the hypothesis that subjective response to acute rewarding effects of alcohol would be related to neural activation during monetary reward receipt relative to loss (in the absence of alcohol). Community-recruited healthy young social drinkers (N = 58) completed four laboratory sessions in which they received alcohol (0.8 g/kg) and placebo in alternating order under double-blind conditions, providing self-report measures of subjective response to alcohol at regular intervals. At a separate visit 1-3 weeks later, they completed a reward-guessing game, the 'Doors' task, during fMRI in a drug-free state. Participants who reported greater motivation (i.e., wanting) to consume more alcohol after a single moderate dose of alcohol also exhibited greater neural activation in the bilateral ventral caudate and the nucleus accumbens during reward receipt relative to loss. Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking). Our study is the first to show that measures of alcohol reward are related to neural indices of monetary reward in humans. These results support growing evidence that individual differences in responses to drug and nondrug reward are linked and together form a risk profile for drug use or abuse, particularly in young adults.",2020,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","['young adults', 'Community-recruited healthy young social drinkers (N\u2009=\u200958']","['alcohol', 'placebo']","['neural activation', 'subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0330504,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Radoman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA. mradom3@uic.edu.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive, Lexington, KY, 40506, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 50N Medical Drive, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841S Maryland Avenue, Chicago, IL, 60637, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0728-6'] 1932,32506233,Does acute stress influence the Pavlovian-to-instrumental transfer effect? Implications for substance use disorders.,"RATIONAL The ability of conditioned stimuli to affect instrumental responding is a robust finding from animal as well as human research and is assumed as a key factor regarding the development and maintenance of addictive behaviour. OBJECTIVES While it is well known that stress is an important factor for relapse after treatment, little is known about the impact of stress on conditioned substance-associated stimuli and their influence on instrumental responding. METHODS We administered in the present study a Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points in a token economy to light to moderate smokers who also indicated to like eating chocolate. After completion of the first two phases of the PIT paradigm (i.e. Pavlovian training and instrumental trainings), participants were randomly allocated to the socially evaluated cold pressor test or a control condition before the final phase of the PIT paradigm, the transfer phase, was administered. RESULTS The presentation of a smoking-related stimulus enhanced instrumental responding for a smoking-related reward (i.e. 'smoking-PIT' effect) and presentation of a chocolate-related stimulus for a chocolate-related reward (i.e. 'chocolate-PIT' effect) in participants aware of the experimental contingencies as indicated by expectancy ratings. However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants. CONCLUSIONS The established role of stress in addiction appears not to be driven by an augmenting effect on the ability of drug stimuli to promote drug-seeking.",2020,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants. ",[],"['PIT paradigm (i.e. Pavlovian training and instrumental trainings', 'socially evaluated cold pressor test', 'Pavlovian-to-instrumental transfer (PIT) paradigm with stimuli associated with smoking- and chocolate-related rewards using points']","['acute stress', 'tobacco choice']",[],"[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0217592,"However, acute stress did not change (i.e. neither enhanced nor attenuated) the 'smoking-PIT' effect or the 'chocolate-PIT' effect, and no overall effect of acute stress on tobacco choice was observed in aware participants. ","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany. sabine.steins-loeber@uni-bamberg.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lörsch', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'van der Velde', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Otto-Friedrich-University of Bamberg, Markusplatz 3, 96047, Bamberg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition, University of Duisburg-Essen, Duisburg, Germany.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Duka', 'Affiliation': 'Sussex Addiction Research and Intervention Centre, School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Ruhr University Bochum, Bochum, Germany.'}]",Psychopharmacology,['10.1007/s00213-020-05534-8'] 1933,32506275,"Preoperative meloxicam versus postoperative meloxicam for pain control, patients' satisfaction and function recovery in hip osteoarthritis patients who receive total hip arthroplasty: a randomized, controlled study.","This study aimed to compare the analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery by preoperative meloxicam versus postoperative meloxicam in treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA). 132 hip OA patients who underwent THA surgery were allocated into postoperative analgesia (POST) and preoperative analgesia (PRE) groups at a 1:1 ratio. In the PRE group, patients took meloxicam 15 mg at 24 h pre-operation, 7.5 mg at 4 h, 24 h, 48 h and 72 h post-operation; in the POST group, patients received meloxicam 15 mg at 4 h post-operation, then 7.5 mg at 24 h, 48 h and 72 h post-operation. Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events were evaluated within 96 h post-operation; meanwhile, Harris hip score was assessed within 6 months post-operation. Pain VAS at rest at 6 h, 12 h, 24 h, and pain VAS at passive movement at 6 h, 12 h were decreased in PRE group compared to POST group. In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group. Additionally, overall satisfaction in PRE group was higher at 24 h, 48 h and 72 h compared to POST group. While Harris hip score was of no difference between POST group and PRE group at M3 or M6. Besides, no difference in adverse events incidence was found between the two groups. In conclusion, preoperative meloxicam achieves better efficacy and similar tolerance compared to postoperative meloxicam in hip OA patients post THA.",2020,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","['hip osteoarthritis patients who receive total hip arthroplasty', '132 hip OA patients who underwent THA surgery', 'treating hip osteoarthritis (OA) patients receiving total hip arthroplasty (THA']","['postoperative analgesia (POST) and preoperative analgesia (PRE', 'meloxicam 15\xa0mg at 4\xa0h post-operation', 'meloxicam', 'Preoperative meloxicam versus postoperative meloxicam', 'meloxicam versus postoperative meloxicam']","['overall satisfaction', 'total consumption of PCA', 'Pain VAS', 'efficacy and similar tolerance', 'adverse events incidence', 'pain VAS at passive movement', ""analgesic effect, patients' satisfaction, tolerance and hip-joint function recovery"", 'Furthermore, postoperative pain, consumption of patient-controlled analgesia (PCA), overall satisfaction and adverse events']","[{'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1128682', 'cui_str': 'meloxicam 15 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",132.0,0.0274409,"In addition, additional consumption of PCA and the total consumption of PCA were both reduced in PRE group compared to POST group.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China. haodunye9398649@163.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, No. 26, Shengli Street, Wuhan, 430014, People's Republic of China.""}]",Inflammopharmacology,['10.1007/s10787-020-00718-2'] 1934,32506278,The effect of systemic erythropoietin and oral prednisolone on recent-onset non-arteritic anterior ischemic optic neuropathy: a randomized clinical trial.,"BACKGROUND To evaluate the effect of systemic erythropoietin, as well as oral steroids, in the management of recent-onset non-arteritic anterior ischemic optic neuropathy (NAION). METHOD Patients diagnosed with NAION within 5 days were randomized into group A (systemic erythropoietin), group B (oral steroids), and group C (control). Group A received 10,000 units of erythropoietin twice a day for 3 days. Group B received oral prednisone 75 mg daily tapered off in 6 weeks. RESULTS The mean best-corrected visual acuity (± SD) at the time of presentation was 1 ± 0.56, 1.01 ± 0.6, and 0.94 ± 0.47 logMAR in groups A, B, and C, respectively (P = 0.140); corresponding values at 6-month follow-up were 0.70 ± 0.44, 0.73 ± 0.35, and 0.75 ± 0.39 logMAR, respectively (P = 0.597). Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04). Peripapillary retinal nerve fiber layers at presentation were 189 ± 58, 193 ± 64, and 199 ± 62 micrometers, respectively (P = 0.779), which decreased to 88 ± 12, 74 ± 25, and 71 ± 18, respectively at 6-month follow-up (P = 0.041). CONCLUSION The findings of our study indicate the beneficial effects of systemic erythropoietin in preserving the function and structure of the optic nerve in recent-onset NAION. TRIAL REGISTRATION Clinical registration number: IR.SBMU.ORC.REC.1397.18.",2020,Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04).,['Patients diagnosed with NAION within 5 days'],"['systemic erythropoietin), group B (oral steroids', 'systemic erythropoietin and oral prednisolone', 'erythropoietin', 'systemic erythropoietin', 'oral prednisone']","['visual acuity values', 'mean best-corrected visual acuity (± SD', 'Peripapillary retinal nerve fiber layers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2242711', 'cui_str': 'Arteritic anterior ischemic optic neuropathy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}]",,0.182408,Fifty-five percent of patients in group A versus 34.3% in group B and 31.2% in group C had an improvement of at least 3 lines in the best-corrected visual acuity values at the 6th month of follow-up visit (P = 0.04).,"[{'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Nikkhah', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahya', 'Initials': 'M', 'LastName': 'Golalipour', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Doozandeh', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pakravan', 'Affiliation': 'Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Esfandiari', 'Affiliation': 'Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, USA. hmdesfandiary@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04781-x'] 1935,32506309,"Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.","INTRODUCTION Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug-drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety. OBJECTIVES The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo. METHODS This 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4] 0-8 ). Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs) were also assessed. RESULTS In total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4] 0-8 (all p < 0.001) but not significantly different from ibuprofen 400 mg. Median TMPR with FDCs and ibuprofen (44.5-54.1 and 56.2 min, respectively) was faster than with placebo (> 720 min; all p < 0.001 vs. placebo). Duration of pain relief was similar with the FDCs and ibuprofen 400 mg (9.7 -11.1 h) and longer than with placebo (1.6 h; all p < 0.001). AE incidence was comparable with all treatments. CONCLUSION Each IBU/APAP FDC provided analgesic efficacy comparable to that with ibuprofen 400 mg and superior to that with placebo. Each FDC provided MPR in < 1 h, duration of pain relief > 9 h, and tolerability similar to that with ibuprofen and placebo. CLINICALTRIALS. GOV REGISTRATION NCT01559259.",2020,All active treatments were superior to placebo for SPRID[4] 0-8 (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"['patients with moderate-to-severe pain following third molar extraction', '394 patients were randomized']","['ibuprofen 400\xa0mg and placebo', 'ibuprofen/acetaminophen (IBU/APAP', 'placebo', 'FDCs and ibuprofen', 'Ibuprofen and Acetaminophen', 'APAP', 'ibuprofen', 'Ibuprofen and acetaminophen']","['Median TMPR with FDCs and ibuprofen', 'time-weighted sum of pain relief and pain intensity difference scores', 'Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs', 'Duration of pain relief', 'duration of pain relief', 'analgesic efficacy', 'AE incidence', 'Postsurgical Dental Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}]",394.0,0.565432,All active treatments were superior to placebo for SPRID[4] 0-8 (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA. david.kellstein@gmail.com.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00310-7'] 1936,32506325,Postoperative online follow-up improves the quality of life of patients who undergo extraction of impacted madibular third molars: a randomized controlled trial.,"OBJECTIVE To evaluate the effect of online follow-up on the quality of life of patients who undergo extraction of impacted mandibular third molars. MATERIALS AND METHODS This study enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups. The test group received an online follow-up on the first, third, and fifth days after tooth extraction, while the control group was not followed up with. Patients in both groups were reexamined on the postoperative seventh day, completing the postoperative symptom severity (PoSSe) scale to comprehensively and quantitatively evaluate their quality of life after tooth extraction. A visual analogue scale (VAS) was used to evaluate the degree of approval for an online follow-up after tooth extraction by 20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old). RESULTS The PoSSe scale scores of the remaining options in the test group were significantly lower than those in the control group. The VAS score of senior doctors for online follow-up was significantly lower than that of young doctors. CONCLUSIONS A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars. Compared with senior doctors, young doctors were more likely to approve an online follow-up after tooth extraction. CLINICAL RELEVANCE Online medical care can be considered as an auxiliary tool to improve the effect of oral treatment.",2020,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"['patients who undergo extraction of impacted mandibular third molars', 'patients who undergo extraction of impacted madibular third molars', 'enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups', '20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old', 'patients who underwent extraction of impacted mandibular third molars']",[],"['quality of life', 'visual analogue scale (VAS', 'PoSSe scale scores', 'postoperative symptom severity (PoSSe) scale', 'VAS score of senior doctors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0438377,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"[{'ForeName': 'Xianghuai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaoqiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Center of Oral Implantology, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China. 654365980@qq.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03388-0'] 1937,32506368,Impact of neurosurgical enhanced recovery after surgery (ERAS) program on health-related quality of life in glioma patients: a secondary analysis of a randomized controlled trial.,"INTRODUCTION A novel neurosurgical enhanced recovery after surgery (ERAS) program shortens postoperative hospital stay and accelerates functional recovery in elective craniotomy patients. There is a need to evaluate the impact of ERAS program on patients' health-related quality of life (HRQOL). METHODS In a single-center randomized controlled trial, patients were randomized 1:1 to receive perioperative ERAS or conventional care. As a secondary outcome, HRQOL was measured with the EORTC QLQ-C30/BN20 prior to randomization (baseline), at discharge, and at 3- and 6-month follow-up. RESULTS A total of 65 patients (ERAS: n = 36, conventional care: n = 29) with pathologically confirmed glioma (WHO grade 2-4) were included in the analysis. Progression-free survival at 6 months and HRQOL at baseline were similar between the two groups. Changes of scores did not vary significantly over time, but differed significantly between intervention groups. A clinically relevant better QoL (at 3-month follow-up), physical functioning (at 6-month follow-up) and role functioning (at discharge) was observed in patients in the ERAS group. Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness (at 3- and 6-month follow-up), weakness of legs (at 3-month follow-up), and nausea/vomiting (at discharge and 6-month follow-up) were significantly lower in the ERAS group. CONCLUSIONS The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care. The intervention has a significant main effect HRQOL changes without significant interaction with time. Future well-powered multicenter studies are warranted to confirm this result and address long-term benefits. This study has been registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=16480) with registration number ChiCTR-INR-16009662.",2020,The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care.,"['conventional care: n\u2009=\u200929) with pathologically confirmed glioma (WHO grade 2-4', 'elective craniotomy patients', '65 patients (ERAS: n\u2009=\u200936', 'glioma patients']","['perioperative ERAS or conventional care', 'neurosurgical enhanced recovery after surgery (ERAS) program', 'surgery (ERAS) program', 'ERAS program']","['HRQOL', 'functioning and symptoms scores', 'health-related quality of life', 'weakness of legs', 'physical functioning', 'nausea/vomiting', 'postoperative hospital stay', 'Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness', 'Progression-free survival']","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427068', 'cui_str': 'Monoparesis - leg'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",65.0,0.095925,The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care.,"[{'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China. he-shiming@163.com.""}]",Journal of neuro-oncology,['10.1007/s11060-020-03548-y'] 1938,32506371,Repeat radiation with bevacizumab and minocycline in bevacizumab-refractory high grade gliomas: a prospective phase 1 trial.,"INTRODUCTION There are no effective treatments for gliomas after progression on radiation, temozolomide, and bevacizumab. Microglia activation may be involved in radiation resistance and can be inhibited by the brain penetrating antibiotic minocycline. In this phase 1 trial, we examined the safety and effect on survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab. METHODS The trial used a 3 + 3 design for dose escalation followed by a ten person dose expansion. Patients received reirradiation with dosing based on radiation oncologist judgment, bevacizumab 10 mg/kg IV every two weeks, and oral minocycline twice a day. Symptom burden was measured using MDASI-BT. Neurocognitive function was measured using the COGSTATE battery. RESULTS The maximum tolerated dose of minocycline was 400 mg twice a day with no unexpected toxicities. The PFS3 was 64.6%, and median overall survival was 6.4 months. Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression. CONCLUSIONS Minocycline 400 mg orally twice a day with bevacizumab and reirradiation is well tolerated by physician and patient reported outcomes in people with gliomas that progress on bevacizumab.",2020,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression. ",['refractory high grade gliomas'],"['temozolomide, and bevacizumab', 'bevacizumab', 'Minocycline 400\xa0mg orally twice a day with bevacizumab and reirradiation', 'minocycline', 'bevacizumab and minocycline']","['toxicities', 'median overall survival', 'Neurocognitive function', 'Symptom burden', 'Symptom burden and neurocognitive function', 'survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",,0.0873686,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression. ","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Cohen', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA. Adam.cohen@hci.utah.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Anker', 'Affiliation': 'Division of Radiation Oncology, University of Vermont Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Burt', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Shrieve', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salzman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Boucher', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03551-3'] 1939,32506421,Author response to: Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.573461,,"[{'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Steinemann', 'Affiliation': 'Clarunis, Pelvic Floor Unit, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.'}]",The British journal of surgery,['10.1002/bjs.11744'] 1940,32506458,Comment on: Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT).,,2020,,['proctological surgery'],"['ropivacaine', 'placebo']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.651947,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parello', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ratto', 'Affiliation': 'Proctology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCSS.'}]",The British journal of surgery,['10.1002/bjs.11745'] 1941,32506481,Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery.,"BACKGROUND It remains uncertain whether individualization of pneumoperitoneum pressures during laparoscopic surgery improves postoperative recovery. This study compared an individualized pneumoperitoneum pressure (IPP) strategy with a standard pneumoperitoneum pressure (SPP) strategy with respect to postoperative recovery after laparoscopic colorectal surgery. METHODS This was a multicentre RCT. The IPP strategy comprised modified patient positioning, deep neuromuscular blockade, and abdominal wall prestretching targeting the lowest intra-abdominal pressure (IAP) that maintained acceptable workspace. The SPP strategy comprised patient positioning according to the surgeon's preference, moderate neuromuscular blockade and a fixed IAP of 12 mmHg. The primary endpoint was physiological postoperative recovery, assessed by means of the Postoperative Quality of Recovery Scale. Secondary endpoints included recovery in other domains and overall recovery, the occurrence of intraoperative and postoperative complications, duration of hospital stay, and plasma markers of inflammation up to postoperative day 3. RESULTS Of 166 patients, 85 received an IPP strategy and 81 an SPP strategy. The IPP strategy was associated with a higher probability of physiological recovery (odds ratio (OR) 2·77, 95 per cent c.i. 1·19 to 6·40, P = 0·017; risk ratio (RR) 1·82, 1·79 to 1·87, P = 0·049). The IPP strategy was also associated with a higher probability of emotional (P = 0·013) and overall (P = 0·011) recovery. Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029). Other endpoints were not affected. CONCLUSION In this cohort of patients undergoing laparoscopic colorectal surgery, an IPP strategy was associated with faster recovery, fewer intraoperative complications and less inflammation than an SPP strategy. Registration number: NCT02773173 ( http://www.clinicaltrials.gov).",2020,Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029).,"['Of 166 patients, 85 received an IPP strategy and 81 an SPP strategy']","['individualized versus standard pneumoperitoneum pressure strategy', 'laparoscopic colorectal surgery', 'individualized pneumoperitoneum pressure (IPP) strategy with a\u2009standard\u2009pneumoperitoneum pressure (SPP']","['Intraoperative adverse events', 'intraoperative complications', 'postoperative recovery', 'plasma neutrophil-lymphocyte ratio', '0·017; risk ratio (RR', 'physiological postoperative recovery, assessed by means of the Postoperative Quality of Recovery Scale', 'recovery in other domains and overall recovery, the occurrence of intraoperative and postoperative complications, duration of hospital stay, and\u2009plasma markers of inflammation up to postoperative day 3']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",166.0,0.537918,Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029).,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Díaz-Cambronero', 'Affiliation': 'Research Group in Perioperative Medicine, Castellón, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mazzinari', 'Affiliation': 'Research Group in Perioperative Medicine, Castellón, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Flor Lorente', 'Affiliation': 'Department of Colorectal Surgery, Castellón, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'García Gregorio', 'Affiliation': 'Research Group in Perioperative Medicine, Castellón, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Robles-Hernandez', 'Affiliation': 'Hospital General Universitario de Castellón, Castellón, Spain.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Olmedilla Arnal', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martin de Pablos', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care and Laboratory of Experimental Intensive Care and Anaesthesiology, Amsterdam University Medical Centre, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Errando', 'Affiliation': 'Department of Anaesthesiology, Consorcio Hospital General Universitario de Valencia, Valencia, and Departments of Anaesthesiology, Castellón, Spain.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Argente Navarro', 'Affiliation': 'Research Group in Perioperative Medicine, Castellón, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11736'] 1942,32506558,Telephone-based motivational interviewing enhanced with individualised personality-specific coping skills training for young people with alcohol-related injuries and illnesses accessing emergency or rest/recovery services: A randomized controlled trial (QuikFix).,"BACKGROUND AND AIMS Recent meta-analyses of motivational interviewing (MI) for reducing risky alcohol use in young people have reported modest effects. Few studies have targeted individual patient factors to increase MI effectiveness. This study determined if MI enhanced with individualised personality-specific coping skills training (QuikFix) was more efficacious than standard MI or an Assessment Feedback/Information (AF/I) control among young people with alcohol-related injuries or illnesses. DESIGN Single-centre, single-blind, three-group superiority randomized controlled trial with 1-, 3-, 6- and 12-month follow ups SETTING: Telephone-intervention, Brisbane, Australia PARTICIPANTS: 398 young people (16-25 years; Mage=20.30 years, SD=2.12; 54% female) with alcohol-related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS). MEASURES The primary outcome was total standard (10 grams ethanol) drinks in the past month (Timeline Followback, TLFB) at 12 months (primary timepoint). Secondary outcomes were total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol-related problems in the past 3 months (Rutgers Alcohol Problem Index). INTERVENTIONS Young people were randomized to two sessions of QuikFix enhanced with individualised personality-specific coping skills training (n=132), two sessions of MI (n=136) or one session of AF/I (n = 130), all delivered by telehealth. FINDINGS QuikFix resulted in greater reductions (all p< 0.0017) in the primary outcome of total standard drinks (M=19.50, CI 99.75%=[11.31-27.68]) than both MI (M=32.61, CI 99.75%=[24.82-40.40];Cohen's D=0.40) and AF/I (M=34.12, CI 99.75%=[26.59-41.65];D=0.45) at 12 months (retention n=324/398, 81%). QuikFix had greater reductions on drinking days (M=3.16, CI 99.75%=[2.37-3.96]) than both MI (M=4.53, CI 99.75%=[3.57-5.48];D=0.38) and AF/I (M=4.69, CI 99.75%=[3.73-5.65];D=0.42) and fewer drinks per drinking day (M=5.02, CI 99.75%=[3.71-6.33]) than AF/I (M=7.15, CI 99.75%=[5.93-8.38;D=0.47) at 12 months. CONCLUSIONS Young people with alcohol-related injuries and/or illnesses who attended emergency department and rest/recovery services and received an individualised personality-specific coping skills training intervention (QuikFix) had greater reductions in the amount of alcohol consumed at 12 months compared with those who received motivational interviewing or an assessment feedback/information intervention.",2020,"FINDINGS QuikFix resulted in greater reductions (all p< 0.0017) in the primary outcome of total standard drinks (M=19.50, CI 99.75%=[11.31-27.68]) than both MI (M=32.61, CI 99.75%=[24.82-40.40];Cohen's D=0.40) and AF/I (M=34.12, CI 99.75%=[26.59-41.65];D=0.45) at 12 months (retention n=324/398, 81%).","['young people with alcohol-related injuries or illnesses', 'Young people with alcohol-related injuries and/or illnesses who attended emergency department and rest/recovery services', 'Young people', '398 young people (16-25 years; Mage=20.30 years, SD=2.12; 54% female) with alcohol-related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS', 'young people with alcohol-related injuries and illnesses accessing emergency or rest/recovery services']","['individualised personality-specific coping skills training intervention (QuikFix', 'motivational interviewing or an assessment feedback/information intervention', 'motivational interviewing (MI', 'Telephone-based motivational interviewing enhanced with individualised personality-specific coping skills training', 'MI enhanced with individualised personality-specific coping skills training (QuikFix', 'QuikFix enhanced with individualised personality-specific coping skills training']","['MI effectiveness', 'total standard drinks', 'total standard (10 grams ethanol) drinks in the past month (Timeline Followback, TLFB', 'total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol-related problems in the past 3 months (Rutgers Alcohol Problem Index', 'drinking days']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",398.0,0.107775,"FINDINGS QuikFix resulted in greater reductions (all p< 0.0017) in the primary outcome of total standard drinks (M=19.50, CI 99.75%=[11.31-27.68]) than both MI (M=32.61, CI 99.75%=[24.82-40.40];Cohen's D=0.40) and AF/I (M=34.12, CI 99.75%=[26.59-41.65];D=0.45) at 12 months (retention n=324/398, 81%).","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'School of Psychology, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Orygen The National Centre of Excellence in Youth Mental Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Pocuca', 'Affiliation': 'School of Psychology, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, Center on Alcoholism, Substance Abuse and Addictions (CASAA), University of New Mexico, Albuquerque, New Mexico, United States.'}, {'ForeName': 'Mark R C', 'Initials': 'MRC', 'LastName': 'Daglish', 'Affiliation': 'Discipline of Psychiatry, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Ross Mc D', 'Initials': 'RMD', 'LastName': 'Young', 'Affiliation': 'School of Psychology & Counselling and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Stoyan', 'Initials': 'S', 'LastName': 'Stoyanov', 'Affiliation': 'School of Psychology, Centre for Youth Substance Abuse Research, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kavanagh', 'Affiliation': 'School of Psychology & Counselling and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.15146'] 1943,32506563,A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care.,"This randomized controlled trial assessed the efficacy of a five-session version of Skills Training in Affective and Interpersonal Regulation (STAIR) among veterans obtaining treatment in primary care. Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26) were enrolled and randomized into either five-session STAIR or treatment as usual (TAU). Assessments of PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2) were assessed at pretreatment, posttreatment, and 3-month follow-up assessments. Participants assigned to the five-session STAIR condition reported significant improvements on all measures, whereas those assigned to TAU showed no change. Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2. The results indicate that five-session STAIR, a brief, skills-focused treatment, may be effective in reducing a range of symptoms and in improving social functioning among veterans treated in primary care settings.",2020,"Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2.","['veterans obtaining treatment in primary care', 'Veterans in Primary Care', 'Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26']","['five-session version of Skills Training', 'Brief Skills Training', 'five-session STAIR or treatment as usual (TAU']","['social functioning', 'Affective and Interpersonal Regulation (STAIR', 'PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",26.0,0.0135656,"Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2.","[{'ForeName': 'Shaili', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gimeno', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Denine A', 'Initials': 'DA', 'LastName': 'Baldor', 'Affiliation': 'Integrated Care Team, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Weiss', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Marylène', 'Initials': 'M', 'LastName': 'Cloitre', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22523'] 1944,32506579,A critical food system program in South Australia and the effects on consumer knowledge and attitudes.,"ISSUE ADDRESSED This study investigated the effects of food system literacy on knowledge and attitudes of food consumers. METHODS A two-week online course critically discussed the food system through three lenses of environmental sustainability, equity and health. Participants were randomly allocated into one Control and two Intervention groups (A & B). Data collection was by online questionnaire pre- and post-intervention, addressing self-perceived food system knowledge, attitudes towards food purchasing behaviours, demographic characteristics, and course evaluation. Differences in knowledge and attitude scores between control and intervention groups were assessed. Subjects were staff and students of XXXXXX University in XXXXXX. [removed for blind peer review] RESULTS: Forty-seven participants completed the course. The completion rate was 71.2%. Knowledge about the food system improved significantly for both Intervention groups when compared to the Control group (p=<0.001). Although attitudes towards food purchasing behaviours also improved significantly for both Intervention groups (p<0.001 and p=0.005 for interventions A and B respectively), the improvements were not significant when compared to the Control group (p=0.065 and p=0.43 for interventions A and B respectively). The on-line methodology received positive feedback from participants. CONCLUSION This two-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption. SO WHAT?: It provides encouraging indications of the potential of food system literacy to empower citizens to make healthier as well as, more environmentally and socially sustainable food choices.",2020,This two-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption.,['Subjects were staff and students of XXXXXX University in XXXXXX'],['food system literacy'],"['completion rate', 'attitudes towards food purchasing behaviours', 'knowledge and attitude scores']","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0230884,This two-week online food system course showed that the pedagogy was appropriate and successful in improving self-perceived knowledge and attitudes towards food consumption.,"[{'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Rohrlach', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Coveney', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ward', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Booth', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Bedford Park, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.370'] 1945,32506663,Novel delivery of cellular therapy to reduce ischaemia reperfusion injury in kidney transplantation.,"Ex-vivo normothermic machine perfusion (NMP) of donor kidneys prior to transplantation provides a platform for direct delivery of cellular therapeutics to optimise organ quality prior to transplantation. Multipotent Adult Progenitor Cells (MAPC ® ) possess potent immunomodulatory properties which could minimise ischaemia reperfusion injury. We investigated the potential capability of MAPC cells in kidney NMP. Pairs (5) of human kidneys, from the same donor, were simultaneously perfused for 7-hours. Kidneys were randomly allocated to receive MAPC treatment or control. Serial samples of perfusate, urine and tissue biopsies were taken for comparison. MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050). A chemotaxis model demonstrated decreased neutrophil recruitment when stimulated with perfusate from MAPC-treated kidneys (p<0.001). Immunofluorescence revealed pre-labelled MAPC cells in the perivascular space of kidneys during NMP. We report the first successful delivery of cellular therapy to a human kidney during NMP. Kidneys treated with MAPC cells demonstrate improvement in clinically relevant parameters and injury biomarkers. This novel method of cell therapy delivery provides an exciting opportunity to recondition organs prior to transplantation.",2020,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","['kidney transplantation', 'human kidney during NMP', 'kidney NMP']","['MAPC treatment or control', 'cellular therapy', 'MAPC cells', 'Ex-vivo normothermic machine perfusion (NMP', 'Multipotent Adult Progenitor Cells (MAPC ® ']","['Immunofluorescence revealed pre-labelled MAPC cells', 'urine-output', 'neutrophil recruitment', 'expression of injury biomarker NGAL', 'microvascular perfusion', 'downregulation of IL-1β (p=0.050) and upregulation of IL-10']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0751982', 'cui_str': 'Neutrophil Recruitment'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.0198533,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Thompson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bates', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ibrahim K', 'Initials': 'IK', 'LastName': 'Ibrahim', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Sewpaul', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stenberg', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Girdlestone', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Georgina C', 'Initials': 'GC', 'LastName': 'Wilkins', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Tingle', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Scott', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Lamos', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Mellor', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Valerie D', 'Initials': 'VD', 'LastName': 'Roobrouck', 'Affiliation': 'ReGenesys, Leuven, Belgium.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Ting', 'Affiliation': 'Athersys Inc, Cleveland, OH, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hosgood', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Nicholson', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fisher', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simi', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Sheerin', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Wilson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16100'] 1946,32506665,The association between serum sex steroid hormone concentrations and intraprostatic inflammation in men without prostate cancer and irrespective of clinical indication for biopsy in the placebo arm of the Prostate Cancer Prevention Trial.,"BACKGROUND Intraprostatic inflammation is an emerging prostate cancer risk factor. Estrogens are pro-inflammatory while androgens are anti-inflammatory. Thus, we investigated whether serum sex steroid hormone concentrations are associated with intraprostatic inflammation to inform mechanistic links among hormones, inflammation, and prostate cancer. METHODS We conducted a cross-sectional study among 247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol. Serum estradiol, estrone, and testosterone were previously measured by immunoassay in pooled baseline and Year 3 serum. Free estradiol and free testosterone were calculated. Inflammation was visually assessed (median of three prostate biopsy cores per man). Polytomous or logistic regression was used to estimate the odds ratio (OR) and 95% confidence interval (CI) of some or all cores inflamed (both vs none) or any core inflamed (vs none) by hormone tertile, adjusting for age, race, and family history. We evaluated effect modification by waist circumference and body mass index (BMI). RESULTS In all, 51.4% had some and 26.3% had all cores inflamed. Free (P-trend = .11) but not total estradiol was suggestively inversely associated with all cores inflamed. In men with waist circumference greater than or equal to 102 cm (P-trend = .021) and BMI ≥ 27.09 kg/m 2 (P-trend = .0037) free estradiol was inversely associated with any core inflamed. Estrone was inversely associated with all cores inflamed (T3: OR = 0.36, 95% CI 0.14-0.95, P-trend = .036). Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05) testosterone were positively associated with any core inflamed, especially free testosterone in men with waist circumference less than 102 cm (T3: OR = 3.51, 95% CI 1.03-12.11, P-trend = .05). CONCLUSIONS In this first study in men without prostate cancer and irrespective of clinical indication for biopsy, contrary to the hypothesis, circulating estrogens appeared to be inversely associated, especially in heavy men, whereas androgens appeared to be positively associated with intraprostatic inflammation.",2020,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","['247 men in the placebo arm of the Prostate Cancer Prevention Trial who had a negative end-of-study biopsy, most (92.7%) performed without clinical indication per trial protocol', 'men without prostate cancer']",[],"['Free estradiol and free testosterone', 'testosterone', 'Inflammation', 'total estradiol', 'waist circumference and body mass index (BMI', 'Serum estradiol, estrone, and testosterone', 'Estrone']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]",[],"[{'cui': 'C0369189', 'cui_str': 'Free estradiol'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",247.0,0.209464,"Total (T3: OR = 1.91, 95% CI 0.91-4.02, P-trend = .11) and free (T3: OR = 2.19, 95% CI 1.01-4.74, P-trend = .05)","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chadid', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Barber', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Nelson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'Gurel', 'Affiliation': 'The Institute of Cancer Research, The Royal Marsden, London, UK.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'The Cancer Therapy and Research Center, CHRISTUS Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'Departments of Obstetrics and Gynecology, and Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Lippman', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Platz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",The Prostate,['10.1002/pros.24023'] 1947,32506733,Methylene blue vs. methyl aminolevulinate photodynamic therapy in combination with oral terbinafine in the treatment of severe dermatophytic toenail onychomycosis: short- and long-term effects.,"BACKGROUND Photodynamic therapy (PDT) kills target microorganisms via reactive oxygen species (ROS) production. PDT seems to be a good alternative treatment option for onychomycosis. OBJECTIVE To compare the efficacy of combined therapies based on oral terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN+MB/PDT) or methyl aminolevulinate (MAL) (TN+MAL/PDT) in the treatment of onychomycosis. METHODS Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly were randomly allocated to receive 9 sessions, separated by 2-week intervals, of urea (40%) plus a PDT protocol mediated by MB (TN+MB/PDT: group I) or mediated by MAL (TN+MAL/PDT: group II). Clinical and mycological efficacy was evaluated at 16, 40 and 52-week follow-up. RESULTS Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II). No side effects or complications were reported in any of the combinations used. Mycological cure rates were significantly higher during the last third of the evaluated period of time, reaching 100% and 90% in group I and group II, respectively, at the 52-week follow-up. In both modalities, complete cure was achieved in 70% of the patients at the 52-week follow-up. CONCLUSIONS TN+MB/PDT and TN+MAL/PDT show similar outcomes in the treatment of toenails with severe onychomycosis. PDT is an effective method to accelerate the TN-mediated healing process.",2020,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","['toenails with severe onychomycosis', 'severe dermatophytic toenail onychomycosis', 'Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly']","['PDT protocol mediated by MB (TN+MB/PDT: group I) or mediated by MAL (TN+MAL/PDT', 'Photodynamic therapy (PDT', 'TN+MB/PDT and TN+MAL/PDT', 'terbinafine', 'PDT', 'Methylene blue vs. methyl aminolevulinate photodynamic therapy', 'terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN+MB/PDT) or methyl aminolevulinate (MAL) (TN+MAL/PDT']","['Onychomycosis Severity Index (OSI) scores', 'Mycological cure rates', 'complete cure', 'Clinical and mycological efficacy', 'side effects or complications']","[{'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0011635', 'cui_str': 'Arthrodermataceae'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0600157', 'cui_str': 'Aminolevulinate'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0247545,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alberdi', 'Affiliation': 'Private clinic of Dr. Alberdi, Aviador Zorita 25, 28020, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Institute of Physical Chemistry Rocasolano, CSIC, Serrano 119, 28006, Madrid, Spain.'}]",Mycoses,['10.1111/myc.13125'] 1948,32506738,Evaluation of the Effect of Maribavir on Cardiac Repolarization in Healthy Participants: Thorough QT/QTc Study.,"Maribavir is an orally bioavailable benzimidazole riboside in clinical development for treatment of cytomegalovirus infection in transplant patients. Maribavir was evaluated in a thorough QT (TQT) study to determine any effects on cardiac repolarization. The effect of maribavir 100 and 1200 mg oral doses on the baseline- and placebo-adjusted QTc interval (delta delta QTc [ddQTc]) and other electrocardiogram (ECG) parameters was assessed in a randomized, phase I, placebo-controlled, 4-period crossover study in healthy participants (males and females ages 18-50). Additionally, maribavir pharmacokinetics, safety, and tolerability were investigated. Moxifloxacin (400 mg) was used as a positive control to demonstrate the study's ability to detect QT prolongation. Digital 12-lead Holter ECG monitoring was performed over 22 hours following study drug administration. Individual (QTcIb), Fridericia's (QTcF), and Bazett's (QTcB) QTc intervals were calculated. Of 52 randomized participants (29 ± 8.1 years old; 31 [60%] males), 50 (96%) completed the study. For both 100-mg and 1200-mg doses of maribavir, analysis of ddQTc demonstrated that the upper bound of the two-sided 90% confidence interval was below the 10-ms threshold at all time points. The concentration-effect analysis demonstrated no relationship between ddQTc and plasma concentrations of maribavir (and its metabolite). There were no clinically meaningful changes in heart rate and systolic blood pressure. The most common adverse event was dysgeusia; no serious adverse events were reported. This TQT study demonstrated that maribavir did not have impact on cardiac repolarization.",2020,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"['Of 52 randomized participants (29 ± 8.1 years old; 31 [60%] males), 50 (96%) completed the study', 'Healthy Participants', 'healthy participants (males and females ages 18-50', 'transplant patients']","['baseline- and placebo-adjusted QTc interval (delta delta QTc [ddQTc]) and other electrocardiogram (ECG', 'Moxifloxacin', 'Maribavir', 'bioavailable benzimidazole riboside', 'placebo']","['Cardiac Repolarization', 'heart rate and systolic blood pressure', 'ddQTc and plasma concentrations of maribavir (and its metabolite', 'maribavir pharmacokinetics, safety, and tolerability', 'cardiac repolarization', ""Individual (QTcIb), Fridericia's (QTcF), and Bazett's (QTcB) QTc intervals""]","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0005050', 'cui_str': 'Benzimidazoles'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",52.0,0.108432,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ilic', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, 02421, USA.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, 02421, USA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, 02421, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, 02421, USA.'}]",Clinical and translational science,['10.1111/cts.12814'] 1949,32493475,A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Primary objective: to evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Secondary objectives: To evaluate the efficacy of melatonin as a prophylactic treatment on prevention of asymptomatic SARS-CoV-2 infection.To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.To evaluate the duration of COVID-19 symptoms in participants receiving melatonin before the infection.To evaluate seroconversion timing post-symptom onset. Exploratory objectives:To compare severity of COVID-19 between men and women.To evaluate the influence of sleep and diet on prevention from SARS-CoV-2 infection.To evaluate the effect of melatonin on the incidence and characteristics of lymphopenia and increase of inflammatory cytokines related to COVID-19. TRIAL DESIGN This is a two-arm parallel randomised double-blind controlled trial to evaluate the efficacy of melatonin versus placebo in the prophylaxis of coronavirus disease 2019 among healthcare workers. PARTICIPANTS Inclusion Criteria: Male or female participants ≥ 18 and ≤ 80 years of age.Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection.Not having a previous COVID19 diagnosis.Understanding the purpose of the trial and not having taken any pre-exposure prophylaxis (PrEP) including HIV PrEP from March 1 st 2020 until study enrolment.Having a negative SARS-CoV 2 reverse-transcription PCR (RT-PCR) result or a negative serologic rapid test (IgM/IgG) result before randomization.Premenopausal women must have a negative urinary pregnancy test in the 7 days before starting the trial treatment.Premenopausal women and males with premenopausal couples must commit to using a high efficiency anticonceptive method. EXCLUSION CRITERIA HIV infection.Active hepatitis B infection.Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis.Osteoporosis.Myasthenia gravis.Pre-existent maculopathy.Retinitis pigmentosa.Bradycardia (less than 50 bpm).Weight less than 40 Kg.Participant with any immunosuppressive condition or hematological disease.Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.Hereditary intolerance to galactose, Lapp lactase deficiency or glucose or galactose malabsorption.Treatment with fluvoxamine.Treatment with benzodiazepines or benzodiazepine analogues such as zolpidem, zopiclone or zaleplon.Pregnancy.Breastfeeding.History of potentially immune derived diseases such as: lupus, Crohn's disease, ulcerative colitis, vasculitis or rheumatoid arthritis.Insulin-dependent diabetes mellitus.Known history of hypersensitivity to the study drug or any of its components.Patients that should not be included in the study at the judgment of the research team. Participants will be recruited from the following eight hospitals in Madrid, Spain: Hospital Universitario La Paz, Hospital Ramón y Cajal, Hospital Infanta Sofía, Hospital 12 de Octubre, Hospital Clínico San Carlos, Hospital Central de la defensa Gómez Ulla,Hospital de La Princesa and Hospital Infanta Leonor. INTERVENTION AND COMPARATOR Experimental: Melatonin (Circadin®, Exeltis Healthcare, Spain): 2 mg of melatonin orally before bedtime for 12 weeks. Comparator: Identical looking placebo (Laboratorios Liconsa, Spain) orally before bedtime for 12 weeks. MAIN OUTCOMES Number of SARS-CoV-2 (COVID-19) symptomatic infections confirmed by polymerase chain reaction (PCR) test or serologic test or according to each centre diagnosis protocol. Primary outcome will be measured until the end of treatment for each participant (until the date of the last dose taken by each patient). RANDOMISATION Patients who meet all inclusion and no exclusion criteria will be randomised, stratified by centres, sex and age (<50 and ≥ 50 years old). The randomisation sequence was created using SAS version 9.4 statistical software (procedure 'PROC PLAN') with a 1:1 allocation. No randomisation seed was specified. The randomisation seed was generated taking the hour of the computer where the program was executed. Randomization will be done centrally through the electronic system RedCAP® in order to conceal the sequence until interventions are assigned BLINDING (MASKING): Participants, caregivers, and those assessing the outcomes are blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm. TRIAL STATUS Protocol version 3.0, 17th of April 2020. Recruitment ongoing. First participant was recruited on the 21st of April 2020. The final participant is anticipated to be recruited on the 31st of May 2020. As of May 18th, 2020, a total of 312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofía and 73 at Hospital 12 de Octubre). TRIAL REGISTRATION EU Clinical Trials Register: 2020-001530-35; Date of trial registration: 13th of April 2020; https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001530-35/ES FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.,"['high-risk contacts (MeCOVID Trial', 'Premenopausal women', 'participants enrolled in this study who develop SARS-CoV-2 infection along the trial', 'Inclusion Criteria: Male or female participants ≥ 18 and ≤ 80 years of age', 'Premenopausal women and males with premenopausal couples', 'Participants will be recruited from the following eight hospitals in Madrid, Spain: Hospital Universitario La Paz, Hospital Ramón y Cajal, Hospital Infanta Sofía, Hospital 12 de Octubre, Hospital Clínico San Carlos, Hospital Central de la defensa Gómez Ulla,Hospital de La Princesa and Hospital Infanta Leonor', 'Participant with any immunosuppressive condition or hematological disease', 'Protocol version 3.0, 17th of April 2020', 'Healthcare workers from the public and private Spanish hospital network at risk of SARS-CoV 2 infection', 'men and women', 'Retinitis pigmentosa', 'participants receiving melatonin before the infection', '312 participants have been enrolled (154 at Hospital La Paz, 85 at Hospital Infanta Sofía and 73 at Hospital 12 de Octubre', 'coronavirus disease 2019 among healthcare workers', '450 participants are planned to be enrolled in this clinical trial, 225 in the experimental arm and 225 in the placebo arm', 'healthcare workers at high risk of SARS-CoV-2 exposure', 'Myasthenia gravis']","['azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone', 'fluvoxamine', 'Comparator', 'Identical looking placebo (Laboratorios Liconsa, Spain', 'Melatonin (Circadin®', 'melatonin', 'benzodiazepines or benzodiazepine', 'placebo']","['Bradycardia', 'Number of SARS-CoV-2 (COVID-19) symptomatic infections confirmed by polymerase chain reaction (PCR) test or serologic test or according to each centre diagnosis protocol', 'Renal failure', 'duration of COVID-19 symptoms', 'Insulin-dependent diabetes mellitus']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0445462', 'cui_str': 'Carlos'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035334', 'cui_str': 'Retinitis pigmentosa'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0072916', 'cui_str': 'Cisapride'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0030863', 'cui_str': 'Pentamidine'}, {'cui': 'C0033216', 'cui_str': 'Procainamide'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}, {'cui': 'C0052585', 'cui_str': 'sparfloxacin'}, {'cui': 'C0039943', 'cui_str': 'Thioridazine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]",312.0,0.378359,To evaluate the efficacy of melatonin to prevent the development of severe COVID-19 in the participants enrolled in this study who develop SARS-CoV-2 infection along the trial.,"[{'ForeName': 'Irene García', 'Initials': 'IG', 'LastName': 'García', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez-Rubio', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Amelia Rodríguez', 'Initials': 'AR', 'LastName': 'Mariblanca', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Lucía Martínez', 'Initials': 'LM', 'LastName': 'de Soto', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Lucía Díaz', 'Initials': 'LD', 'LastName': 'García', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Jaime Monserrat', 'Initials': 'JM', 'LastName': 'Villatoro', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Javier Queiruga', 'Initials': 'JQ', 'LastName': 'Parada', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Enrique Seco', 'Initials': 'ES', 'LastName': 'Meseguer', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Rosales', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'González', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Carcas', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Oliva', 'Affiliation': 'School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. pedro.oliva@salud.madrid.org.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Borobia', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, La Paz University Hospital - IdiPAZ, Paseo de la Castellana, 261, 28046, Madrid, Spain. alberto.borobia@salud.madrid.org.'}]",Trials,['10.1186/s13063-020-04436-6'] 1950,32493478,Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES Primary Objective • To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection Secondary objectives • To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults • To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection • To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group • To test the efficacy of HCQ to prevent incident COVID-19 TRIAL DESIGN: This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus. PARTICIPANTS This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC). Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a.Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)b.Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case5.Access to device and internet for Telehealth visits6.Not planning to take HCQ in addition to the study medication Exclusion criteria Participants are excluded from the study if any of the following criteria apply: 1.Known hypersensitivity to HCQ or other 4-aminoquinoline compounds2.Currently hospitalized3.Symptomatic with subjective fever, cough, or shortness of breath4.Current medications exclude concomitant use of HCQ5.Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.6.History of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period INTERVENTION AND COMPARATOR: Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies: •HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days MAIN OUTCOMES: The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group. RANDOMISATION Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker). BLINDING (MASKING) This is a blinded study. HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour. The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The sample size for the study is N=2 000 participants randomized 1:1 to either HCZ (n=1 000) and ascorbic acid (n=1 000). TRIAL STATUS Protocol version: 1.2 05 April 2020 Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020. TRIAL REGISTRATION ClinicalTrials.gov, Protocol Registry Number: NCT04328961 Date of registration: April 1, 2020, retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group •,"['2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test', 'Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection', 'adults •', 'Protocol version: 1.2 05 April 2020', '1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a', 'of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of', 'adults exposed to the virus', 'severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19', 'Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply']","['placebo-equivalent (ascorbic acid', 'HCZ', 'hydroxychloroquine', 'chloroquine, mefloquine, artemether, or lumefantrine.6.History', 'HCQ', 'HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP', '•HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid', 'digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine', 'HCQ or ascorbic acid', 'HCQ PEP', 'HCQ and ascorbic acid', 'Hydroxychloroquine (HCQ', 'ascorbic acid']","['incidence of SARS-CoV-2 infection', 'safety and tolerability']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0052429', 'cui_str': 'artemether'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.289709,To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group •,"[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA. rbarnaba@uw.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wener', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wesche', 'Affiliation': 'Certara, Princeton, NJ, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04446-4'] 1951,32493494,"Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial.","BACKGROUND SARS-CoV-2 infection presents a high transmission in the group of health professionals in Spain (12-15% infected). Currently there is no accepted chemoprophylaxis but hydroxychloroquine (HDQ) is known to inhibit the coronavirus in vitro. Our hypothesis is that oral administration of hydroxychloroquine to healthcare professionals can reduce the incidence and prevalence of infection as well as its severity in this group. METHODS Design: Prospective, single center, double blind, randomised, controlled trial (RCT). PARTICIPANTS Adult health-care professionals (18-65 years) working in areas of high exposure and high risk of transmission of SARS-COV-2 (COVID areas, Intensive Care Unit -ICUs-, Emergency, Anesthesia and all those performing aerosol-generating procedures) will be included. Exclusion criteria include previous infection with SARS CoV2 (positive SARS-CoV-2 PCR or IgG serology), pregnancy or lactation, any contraindication to hydroxychloroquine or evidence of unstable or clinically significant systemic disease. INTERVENTIONS Patients will be randomized (1:1) to receive once-daily oral Hydroxychloroquine 200mg for two months (HC group) or placebo (P group) in addition to the protective measures appropriate to the level of exposure established by the hospital. A serological evaluation will be carried out every 15 days with PCR in case of seroconversion, symptoms or risk exposure. Primary outcome is the percentage of subjects presenting infection (seroconversion and/or PCR +ve) by the SARS-Cov-2 virus during the observation period. Additionally, both the percentage of subjects in each group presenting Pneumonia with severity criteria (Curb 65 ≥2) and that of subjects requiring admission to ICU will be determined. DISCUSSION While awaiting a vaccine, hygiene measures, social distancing and personal protective equipment are the only primary prophylaxis measures against SARS-CoV-2, but they have not been sufficient to protect our healthcare professionals. Some evidence of the in vitro efficacy of hydroxychloroquine against this virus is known, along with some clinical data that would support the study of this drug in the chemoprophylaxis of infection. However, there are still no data from controlled clinical trials in this regard. If our hypothesis is confirmed, hydroxychloroquine can help professionals fight this infection with more guarantees. PARTICIPANTS This is a single-center study that will be carried out at the Marqués de Valdecilla University Hospital. 450 health professionals working at the Hospital Universitario Marqués de Valdecilla in areas of high exposure and high risk of transmission of SARS COV2 (COVID hospital areas, Intensive Care Unit, Emergency, Anesthesia and all those performing aerosol-generating procedures) will be included. INCLUSION CRITERIA 1) Health professionals aged between 18 and 65 years (inclusive) at the time of the first screening visit; 2) They must provide signed written informed consent and agree to comply with the study protocol; 3) Active work in high exposure areas during the last two weeks and during the following weeks. EXCLUSION CRITERIA 1) Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation. INTERVENTION AND COMPARATOR Two groups will be analyzed with a 1: 1 randomization rate. 1)Intervention: (n = 225): One 200 mg hydroxychloroquine sulfate coated tablet once daily for two months.2)Comparator (control group) (n = 225): One hydroxychloroquine placebo tablet (identical to that of the drug) once daily for two months MAIN OUTCOMES: The primary outcome of this study will be to evaluate: number and percentage of healthcare personnel presenting symptomatic and asymptomatic infection (see ""Diagnosis of SARS CoV2 infection"" below) by the SARS-Cov2 virus during the study observation period (8 weeks) in both treatment arms;number and percentage of healthcare personnel in each group presenting with Pneumonia with severity criteria (Curb 65 ≥2) and number and percentage of healthcare personnel requiring admission to the Intensive Care Unit (ICU) in both treatment arms. DIAGNOSIS OF SARS COV2 INFECTION: Determination of IgA, IgM and IgG type antibodies against SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA kit (EUROIMMUN Medizinische Labordiagnostika AG, Germany) every two weeks. In cases of seroconversion, a SARS-CoV-2 PCR will be performed to rule out / confirm an active infection (RT-PCR in One Step: RT performed with mastermix (Takara) and IDT probes, following protocol published and validated by the CDC Evaluation of COVID-19 in case of SARS-CoV-2 infection RANDOMISATION: Participants will be allocated to intervention and comparator groups according to a balanced randomization scheme (1: 1). The assignment will be made through a computer-generated numeric sequence for all participants BLINDING (MASKING): Both participants and investigators responsible for recruiting and monitoring participants will be blind to the assigned arm. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Taking into account the current high prevalence of infection in healthcare personnel in Spain (up to 15%), to detect a difference equal to or greater than 8% in the percentage estimates through a two-tailed 95% CI, with a statistical power of 80% and a dropout rate of 5%, a total of 450 participants will need to be included (250 in each arm). TRIAL STATUS The protocol approved by the health authorities in Spain (Spanish Agency for Medicines and Health Products ""AEMPS"") and the Ethics and Research Committee of Cantabria (CEIm Cantabria) corresponds to version 1.1 of April 2, 2020. Currently, recruitment has not yet started, with the start scheduled for the second week of May 2020. TRIAL REGISTRATION Eudra CT number: 2020-001704-42 (Registered on 29 March 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation. ","['450 health professionals working at the Hospital Universitario Marqués de Valdecilla in areas of high exposure', 'Eudra CT number: 2020-001704-42 (Registered on 29 March 2020', '1)Intervention: (n = 225', 'Adult health-care professionals (18-65 years) working in areas of high exposure and high risk of transmission of SARS-COV-2 (COVID areas, Intensive Care Unit -ICUs-, Emergency, Anesthesia and all those performing aerosol-generating procedures', 'Health professionals aged between 18 and 65 years (inclusive) at the time of the first screening visit; 2', 'healthcare personnel in the hospital setting']","['hydroxychloroquine chemoprophylaxis', 'hydroxychloroquine placebo', 'Hydroxychloroquine 200mg for two months (HC group) or placebo', 'hydroxychloroquine or chloroquine', 'hydroxychloroquine', 'hydroxychloroquine (HDQ', 'hydroxychloroquine sulfate', 'tamoxifen or raloxifene']","[' number and percentage of healthcare personnel presenting symptomatic and asymptomatic infection (see ""Diagnosis of SARS CoV2 infection"" below', 'efficacy and safety', 'number and percentage of healthcare personnel requiring admission to the Intensive Care Unit (ICU', 'Determination of IgA, IgM and IgG type antibodies against SARS-CoV-2', 'percentage of subjects presenting infection (seroconversion and/or PCR +ve) by the SARS-Cov-2 virus']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C1171177', 'cui_str': 'Adult care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0275522', 'cui_str': 'Subclinical infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]",450.0,0.193721,"Previous infection with SARS CoV2 (positive coronavirus PCR or positive serology with SARS Cov2 negative PCR and absence of symptoms); 2) Current treatment with hydroxychloroquine or chloroquine; 3) Hypersensitivity, allergy or any contraindication for taking hydroxychloroquine, in the technical sheet; 4) Previous or current treatment with tamoxifen or raloxifene; 5) Previous eye disease, especially maculopathy; 6) Known heart failure (Grade III to IV of the New York Heart Association classification) or prolonged QTc; 7) Any type of cancer (except basal cell) in the last 5 years; 6) Refusal to give informed consent; 8) Evidence of any other unstable or clinically significant untreated immune, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness; 9) Antibodies positive for the human immunodeficiency virus; 10) Significant kidney or liver disease; 11) Pregnancy or lactation. ","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cuadrado-Lavín', 'Affiliation': 'Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Av. Valdecilla, 25, 39008, Santander, Cantabria, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Olmos', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Cifrian', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gimenez', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Gandarillas', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'García-Saiz', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Maria Henar', 'Initials': 'MH', 'LastName': 'Rebollo', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Martínez-Taboada', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'López-Hoyos', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Fariñas', 'Affiliation': 'Marqués de Valdecilla Research Institute (IDIVAL), s/n, Calle Cardenal Herrera Oria, 39011, Santander, Cantabria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Crespo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, School of Medicine, University of Cantabria, Av. Valdecilla, 25, 39008, Santander, Cantabria, Spain. javiercrespo1991@gmail.com.'}]",Trials,['10.1186/s13063-020-04400-4'] 1952,32493500,The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial.,"BACKGROUND Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer, Nanoseal, commonly used in Japan. METHODS/DESIGN This study protocol is a two-arm, parallel, pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses. DISCUSSION CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin-collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor. TRIAL REGISTRATION UMIN Clinical Trials Registry (UMIN-CTR), ID: UMIN000038072. Registered on 21 September 2019. TRIAL STATUS This study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (Hanke, Am Dent Assoc 27:1379-1393, 1940).",2020,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses. ","['Japan', 'Forty DH patients']",['novel zinc-containing desensitizer'],"['quality of life', 'dentin hypersensitivity', 'reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0917467,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses. ","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan. matsuurat@nagasaki-u.ac.jp.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Mae', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohira', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Nakazono', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kajiro', 'Initials': 'K', 'LastName': 'Yanagiguchi', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}]",Trials,['10.1186/s13063-020-04426-8'] 1953,32502358,Cognitive behavioral therapy as an adjuvant therapy in acne excoriée: a randomized controlled clinical trial.,"Background: Acne excoriée (AE) is a difficult challenge in dermatology practice. AE is mostly associated with some psychiatric disorders particularly mood disorders. Thus, patients generally continue to manipulate their lesions. It was aimed to compare the effectiveness of cognitive behavioral therapy (CBT) as an adjuvant treatment for AE in a randomized controlled clinical trial. Methods: Thirty-two adults with AE were randomly assigned to CBT or control group. Both the groups received similar standard medication. Furthermore, eight sessions of CBT were held during 2 months in CBT group. Self-reported Skin Picking Scale (SPS), clinical severity rating, beck anxiety and depression inventories were determined at the baseline and after 2-month follow-up. Results: Participants in CBT group showed significantly more improvement on clinical severity score ( p =.01) as well as SPS score ( p =.02) after 2-month follow-up, in comparison to the control group. Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls ( p value .01 for both anxiety and depression). Conclusion: CBT constitutes a utile treatment option for AE and should be considered as an adjuvant therapy in clinical setting.",2020,Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls (p value 0.01 for both anxiety and depression). ,"['Methods : Thirty-two adults with AE', 'Acne excoriée']","[' ', 'Acne excoriée (AE', 'CBT', 'Cognitive behavioral therapy', 'cognitive behavioral therapy (CBT']","['Self-reported Skin Picking Scale (SPS), clinical severity rating, beck anxiety and depression inventories', 'SPS score', 'clinical severity score', 'Depression and anxiety scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1696701', 'cui_str': 'Dermatillomania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",32.0,0.0318528,Depression and anxiety scores were significantly diminished after two months among CBT group in comparison to controls (p value 0.01 for both anxiety and depression). ,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mashayekhi Goyonlo', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam Saeidi', 'Initials': 'MS', 'LastName': 'Sardabi', 'Affiliation': 'Department of Industrial and Organizational Psychology, Faculty of Educational Sciences and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Arezoo Moradi', 'Initials': 'AM', 'LastName': 'Tavalaei', 'Affiliation': 'Department of Psychology, Faculty of Educational Sciences and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khoshnevisan', 'Affiliation': 'Khorasan Higher Education Institution, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Razmara', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1776207'] 1954,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma. METHODS GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment. FINDINGS In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths. INTERPRETATION Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial. FUNDING F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X'] 1955,32503869,Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.,"OBJECTIVES Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC). DESIGN AND SETTING This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST). PARTICIPANTS Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252). PRIMARY OUTCOMES Primary outcomes were psychosocial consequences measured at five time points. RESULTS False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives. CONCLUSIONS Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes. TRIAL REGISTRATION NUMBER NCT00496977.",2020,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","['Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire', 'Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group']",['false-positive lung cancer CT screening'],"['lung cancer mortality', 'psychosocial consequences measured at five time points', 'lung cancer screening', 'Psychosocial consequences of false positives', 'true positives and false positives', 'negative psychosocial consequences', 'false positives or true positives']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0269201,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","[{'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034682'] 1956,32503877,Inhibition of Bruton tyrosine kinase in patients with severe COVID-19.,"Patients with severe COVID-19 have a hyperinflammatory immune response suggestive of macrophage activation. Bruton tyrosine kinase (BTK) regulates macrophage signaling and activation. Acalabrutinib, a selective BTK inhibitor, was administered off-label to 19 patients hospitalized with severe COVID-19 (11 on supplemental oxygen; 8 on mechanical ventilation), 18 of whom had increasing oxygen requirements at baseline. Over a 10-14 day treatment course, acalabrutinib improved oxygenation in a majority of patients, often within 1-3 days, and had no discernable toxicity. Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation. At the end of acalabrutinib treatment, 8/11 (72.7%) patients in the supplemental oxygen cohort had been discharged on room air, and 4/8 (50%) patients in the mechanical ventilation cohort had been successfully extubated, with 2/8 (25%) discharged on room air. Ex vivo analysis revealed significantly elevated BTK activity, as evidenced by autophosphorylation, and increased IL-6 production in blood monocytes from patients with severe COVID-19 compared with blood monocytes from healthy volunteers. These results suggest that targeting excessive host inflammation with a BTK inhibitor is a therapeutic strategy in severe COVID-19 and has led to a confirmatory international prospective randomized controlled clinical trial.",2020,"Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation.","['19 patients hospitalized with severe COVID-19 (11 on supplemental oxygen; 8 on mechanical ventilation), 18 of whom had increasing oxygen requirements at baseline', 'patients with severe COVID-19']","['Bruton tyrosine kinase (BTK', 'BTK inhibitor']","['inflammation - C-reactive protein and IL-6 - normalized quickly', 'elevated BTK activity', 'discernable toxicity', 'IL-6 production in blood monocytes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}]",,0.111792,"Measures of inflammation - C-reactive protein and IL-6 - normalized quickly in most patients, as did lymphopenia, in correlation with improved oxygenation.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Roschewski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Michail S', 'Initials': 'MS', 'LastName': 'Lionakis', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Roswarski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'M Andrew', 'Initials': 'MA', 'LastName': 'Monticelli', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roshon', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Wrzesinski', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jigar V', 'Initials': 'JV', 'LastName': 'Desai', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Zarakas', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Collen', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamdy', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Wright', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Chung', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'Staudt', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD.""}, {'ForeName': 'Wyndham H', 'Initials': 'WH', 'LastName': 'Wilson', 'Affiliation': ""Lymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD; Fungal Pathogenesis Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, MD; Willamette Valley Cancer Institute and Research Center, US Oncology, Eugene, OR; Hematology-Oncology Department, Walter Reed National Military Medical Center, Bethesda, MD; John Theurer Cancer Center, Hackensack Meridian and School of Medicine at Seton Hall, NJ; Rocky Mountain Cancer Center, US Oncology, Colorado Springs, CO; Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado Springs, CO; US Acute Care Solutions, Canton, OH; Department of Medicine, St. Peter's Hospital and US Oncology, Albany, NY; Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; Acerta Pharma, South San Francisco, CA; Biometric Research Branch, Division of Cancer Diagnosis and Treatment, National Cancer Institute, Bethesda, MD, USA AstraZeneca, One MedImmune Way, Gaithersburg, MD wilsonw@mail.nih.gov.""}]",Science immunology,['10.1126/sciimmunol.abd0110'] 1957,32503946,Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.,"BACKGROUND We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety. METHODS This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS. RESULTS At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively. CONCLUSIONS This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies. TRIAL REGISTRATION NUMBER NCT01515189.",2020,"In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","['patients with advanced melanoma', 'patients with untreated or previously treated unresectable stage III or IV melanoma', 'patients with advanced melanoma who started metastatic treatment with']","['ipilimumab monotherapy', 'ipilimumab']","['OS', 'median OS', 'Overall survival', 'sustained long-term survival', 'median OS of patients with asymptomatic brain metastasis', 'overall survival (OS', 'incidence of grade 3/4 treatment-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.585321,"In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","[{'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Unit of Melanoma Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan Medical University, Poznan, Poland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Villejuif and Paris-Sud-University, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': ""Hospital Clinic and Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM, Dermatology and CIC, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie Institute-Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': ""Clinique de Dermatologie, Unité d'Onco-Dermatologie, INSERM U1189, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.""}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Center, The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Oncodermatology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Eberhard Karls Universitat Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancers Department, Aix-Marseille University, APHM, Marseille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Oncodermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoeller', 'Affiliation': 'Division of General Dermatology and Dermato-Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Unit of Medical Oncology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'Department of Dermatology, University Hospital Centre Reims, Reims, Champagne-Ardenne, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Operative Dermatology and Dermato-Oncology, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Department of Oncology, Wojewodzkie Centrum Oncologii, Gdańsk, Poland.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Instituto Toscano Tumori, Siena, Italy.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391'] 1958,32503948,Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.,"BACKGROUND Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs. METHODS The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis. RESULTS ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS). CONCLUSIONS ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.",2020,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS). ","['patients with advanced melanoma', 'patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs', 'patients with lung cancer treated with', 'patients with NSCLC']","['atezolizumab', 'POPLAR (atezolizumab vs docetaxel', 'docetaxel', 'Atezolizumab-treated patients achieving ETS']","['modest OS', 'PFS', 'OS', 'effect size for ETS', 'overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF', 'TDD in HRQoL', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0183841', 'cui_str': 'TDD'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.160724,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS). ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000500'] 1959,32506861,Effect of Huatan Jieyu granules in treatment of Parkinson's disease patients with sleep disorder identified as symptom pattern of phlegma-heat-stirring wind.,"OBJECTIVE To investigate the safety and efficacy of Huatan Jieyu granules in treatment of Parkinson's disease (PD) patients with sleep disorder identified as symptom pattern of phlegma-heat-stirring wind in terms of the theory of Traditional Chinese Medicine. METHODS In total, 107 Parkinson's disease patients with sleep disorders identified as symptom pattern of phlegma-heat-stirring wind were selected and randomly divided into the experimental group (55 cases) and the control group (52 cases). Both groups were given basic treatment with prednisone. The experimental group of patients was treated with Huatan Jieyu granules and the control group of patents was treated with only the basic treatment. Treatment lasted for 4 weeks. Sleep polygraph were recorded before the study as well as 3 months and 6 months after treatment. RESULTS After treated with Huatan Jieyu granules, the total sleep time, and the percentage of non rapid eye movement 2 (NREM 2), non rapid eye movement 3 (NREM 3) and rapid eye movement (REM) sleep period increased significantly, while the percentage of NREM1 sleep period decreased significantly compared with before treatment (P < 0.05). CONCLUSION The treatment of PD patients with sleep disorder by Huatan Jieyu granules can improve their sleep structure and their sleep quality.",2020,"After treated with Huatan Jieyu granules, the total sleep time, and the percentage of non rapid eye movement 2 (NREM 2), non rapid eye movement 3 (NREM 3) and rapid eye movement (REM) sleep period increased significantly, while the percentage of NREM1 sleep period decreased significantly compared with before treatment (P < 0.05). ","['PD patients with sleep disorder', ""107 Parkinson's disease patients with sleep disorders identified as symptom pattern of phlegma-heat-stirring wind"", ""Parkinson's disease (PD) patients with sleep disorder identified as symptom pattern of phlegma-heat-stirring wind in terms of the theory of Traditional Chinese Medicine"", ""Parkinson's disease patients with sleep disorder identified as symptom pattern of phlegma-heat-stirring wind""]","['prednisone', 'Huatan Jieyu granules']","['total sleep time', 'sleep structure and their sleep quality', 'Sleep polygraph', 'safety and efficacy', 'percentage of non rapid eye movement 2 (NREM 2), non rapid eye movement 3 (NREM 3) and rapid eye movement (REM) sleep', 'percentage of NREM1 sleep period']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0436318', 'cui_str': 'Symptom pattern'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0182338', 'cui_str': 'Polygraph'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}]",107.0,0.0116982,"After treated with Huatan Jieyu granules, the total sleep time, and the percentage of non rapid eye movement 2 (NREM 2), non rapid eye movement 3 (NREM 3) and rapid eye movement (REM) sleep period increased significantly, while the percentage of NREM1 sleep period decreased significantly compared with before treatment (P < 0.05). ","[{'ForeName': 'Meijun', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Chongshan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Yaodan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Qizheng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Honghui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Surgical Department of Neurosurgery, Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province, Chengdu 610072, China.'}, {'ForeName': 'Shuoguo', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}, {'ForeName': 'Dongdong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Medical Department of Neurology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.03.015'] 1960,32506882,Use of a probiotic mixture containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3 as prophylaxis to reduce the incidence of acute gastroenteritis and upper respiratory tract infections in children.,"BACKGROUND For healthy children, attending communities such as nurseries, kindergartens or schools, exposes them to the risk of acute gastroenteritis (AGE) and/or upper respiratory tract infections (URTIs). We therefore evaluated whether the use of a well-documented probiotic formula could act as prophylaxis for AGE and URTIs, reducing the risk of occurrence. METHODS In a randomized study, we tested a probiotic mixture containing Bifidobacterium animalis subspecies lactis BB-12 and Enterococcus faecium L3 on 94 healthy children, comparing the incidence and duration of episodes of AGE and the incidence of URTIs to those of a control group of 109 healthy, untreated subjects. In a subgroup consisting of 34 healthy, treated children, we also evaluated salivary IgA levels. RESULTS The use of the probiotic formula significantly reduced the incidence and duration of episodes of AGE by 82% and 45%, respectively, and the incidence and duration of episodes of URTIs by 84% and 50%. Salivary IgA levels significantly increased three-fold after 90 days of probiotic treatment. The probiotic formula was well tolerated and no side effects occurred. CONCLUSIONS According to our results, use of the probiotic strains BB-12 and L3 statistically reduced the risk of AGE and URTIs in healthy children and increased levels of salivary IgA.",2020,"The use of the probiotic formula significantly reduced the incidence and duration of episodes of AGE by 82% and 45%, respectively, and the incidence and duration of episodes of URTIs by 84% and 50%.","['109 healthy, untreated subjects', 'children', 'healthy children', '94 healthy children', 'healthy children, attending communities such as nurseries, kindergartens or schools']","['probiotic mixture containing Bifidobacterium animalis subspecies lactis BB-12 and Enterococcus faecium L3', 'probiotic mixture containing Bifidobacterium animalis subsp']","['incidence and duration of episodes of AGE', 'risk of AGE and URTIs', 'incidence and duration of episodes of URTIs', 'Salivary IgA levels', 'tolerated and no side effects', 'salivary IgA levels', 'levels of salivary IgA']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0085495', 'cui_str': 'Enterococcus faecium'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C1277748', 'cui_str': 'Salivary IgA measurement'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",94.0,0.0255789,"The use of the probiotic formula significantly reduced the incidence and duration of episodes of AGE by 82% and 45%, respectively, and the incidence and duration of episodes of URTIs by 84% and 50%.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Pierro', 'Affiliation': 'Velleja Research, Milan, Italy - f.dipierro@vellejaresearch.com.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Lo Russo', 'Affiliation': 'ATS Milano, Milan, Italy.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Danza', 'Affiliation': 'ATS Milano, Milan, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Basile', 'Affiliation': 'ATS Milano, Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Soardo', 'Affiliation': 'ATS Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Capocasale', 'Affiliation': 'ASP Crotone, Crotone, Italy.'}, {'ForeName': 'Sandro B', 'Initials': 'SB', 'LastName': 'Paparone', 'Affiliation': 'ASP Messina, Messina, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Paletta', 'Affiliation': 'ASP Cosenza, Cosenza, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Lanza', 'Affiliation': 'ASP Cosenza, Cosenza, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Schiavone', 'Affiliation': 'ASP Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Risso', 'Affiliation': 'Health Sciences Department, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': 'ATS Milano, Milan, Italy.'}]",Minerva pediatrica,['10.23736/S0026-4946.20.05925-3'] 1961,32506922,Exploratory Analysis of the Impact of an mHealth Medication Adherence Intervention on Tacrolimus Trough Concentration Variability: Post Hoc Results of a Randomized Controlled Trial.,"Background: Medication nonadherence is a leading cause of late allograft loss in kidney transplantation (KT). Tacrolimus trough coefficient of variation (CV), measured using the coefficient of variation, is strongly correlated with acute rejection, graft function, and graft loss. Objective: The objective of this study was to determine if this mobile health (mHealth) intervention aimed at improving medication adherence in a nonadherent KT population would affect high intrapatient tacrolimus variability. Methods: A 6-month, prospective, parallel-arm, randomized controlled clinical trial was conducted to determine the effects of an mHealth intervention on tacrolimus CV. Intervention arm participants utilized an electronic medication tray and an mHealth app to monitor home-based adherence. Tailored motivational reinforcement messages were delivered to promote competence for adherence. Tacrolimus CV was measured using a 12-month rolling average, assessed at monthly intervals (6-month intervention period and 6 months after completion of the study); 80 were included, 40 in each arm. Results: At baseline, tacrolimus CV was similar between arms (37% ± 15% intervention, 37% ± 13% control, P = 0.894). Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. Conclusion and Relevance: High tacrolimus CV is a risk factor for acute rejection and graft loss; these results offer the potential promise of improved medication adherence and clinical outcomes through the use of innovative technology.",2020,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. ",['kidney transplantation (KT'],"['mHealth intervention', 'mHealth Medication Adherence Intervention', 'tacrolimus CV', 'Tacrolimus CV', 'electronic medication tray and an mHealth app to monitor home-based adherence']","['proportion achieving low tacrolimus CV', 'Tacrolimus trough coefficient of variation (CV', 'tacrolimus CV', 'mean 12-month tacrolimus CVs', 'acute rejection, graft function, and graft loss']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}]",,0.159573,"Patients randomized to the intervention had a significant reduction in mean 12-month tacrolimus CVs ( P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV (tacrolimus CV < 40%; P = 0.001), as compared with the control arm. ","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'McGillicuddy', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Chandler', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Luke R', 'Initials': 'LR', 'LastName': 'Sox', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028020931806'] 1962,32506940,Twelve-week intradialytic cycling exercise improves physical functional performance with gain in muscle strength and endurance: a randomized controlled trial.,"OBJECTIVE To evaluate the effect of intradialytic cycling exercise on physical functional performance with gain in muscle strength and endurance in end-stage renal disease patients with haemodialysis. DESIGN Randomized controlled trial, with repeated measurements at baseline and after 4, 8, and 12 weeks of intradialytic cycling exercise. SETTING A 50-bed haemodialysis centre in a regional hospital in Taiwan. SUBJECTS Seventy-six regular haemodialysis patients, recruited and equally and randomly assigned to exercise and control groups. INTERVENTION The intradialytic cycling exercise was performed for 12 weeks and comprised warm-up, main, and cool-down exercise phases. A stationary cycling equipment was used, which involved aerobic and resistance modalities. The intensity was maintained at somewhat hard exertion. Each intradialytic cycling exercise was implemented for 30 minutes, starting at the second hour of treatment. MAIN MEASURE Measured outcomes were 6-minute walk distance, time taken to complete 10 sit-to-stand-to-sit cycles and number of sit-to-stand-to-sit cycles in 60 seconds. RESULTS Average (standard deviation) participant age was 55.47 (13.00) years. Therefore, the 6-minute walk distance was significantly different at weeks 8 ( P  = 0.01) and 12 ( P  < 0.001) in the exercise group compared with that in the control group at baseline. Notably, sit-to-stand-to-sit outcomes ( P  = 0.01) significantly influenced the 6-minute walk distance. Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). CONCLUSION Twelve-week intradialytic exercise for patients on haemodialysis can improve physical functional performance with gain muscle strength and endurance. This is a safe and effective method for improving health.",2020,"Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). ","['muscle strength and endurance', 'end-stage renal disease patients with haemodialysis', 'Seventy-six regular haemodialysis patients', 'A 50-bed haemodialysis centre in a regional hospital in Taiwan']",['intradialytic cycling exercise'],"['6-minute walk distance, time taken to complete 10 sit-to-stand-to-sit cycles and number of sit-to-stand-to-sit cycles in 60\u2009seconds', '6-minute walk distance', 'Sit-to-stand-to-sit outcomes', 'physical functional performance']","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}]",76.0,0.0517663,"Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). ","[{'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei.'}, {'ForeName': 'Mei-Hua', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, Taipei.'}, {'ForeName': 'Chin-Che', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'Heng Chun Christian Hospital, Kaohsiung.'}, {'ForeName': 'Yueh-Min', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': 'Ching Kuo Institute of Management and Health, Keelung.'}]",Clinical rehabilitation,['10.1177/0269215520921923'] 1963,32507128,Evaluation of the effect of naltrexone coadministration on the pharmacokinetics of oxycodone in a randomized phase 1 clinical trial
.,"OBJECTIVE Oxycodone is a centrally acting µ-opioid agonist used as a strong analgesic. The opioid receptor antagonist -naltrexone is often coadministered to healthy subjects in clinical trials evaluating the pharmacokinetics (PK) of oxycodone to minimize its pharmacodynamic opioid effects. One objective of this relative bioavailability trial in healthy subjects was to investigate the effect of naltrexone on the PK of oxycodone. MATERIALS AND METHODS A randomized, single-dose, parallel-group, within-groups crossover, clinical trial was conducted in 24 healthy subjects. 12 subjects were to receive a new oxycodone prolonged-release (PR) tablet (test) with naltrexone (T+) and without naltrexone (T) in the fasted state. Additionally, 12 subjects were to receive an Oxygesic PR tablet (reference) with naltrexone (R+) and without naltrexone (R) in the fasted state. Naltrexone was given orally 1.5 hours prior to each oxycodone administration. Pharmacokinetics, safety, and tolerability were assessed. RESULTS The PK parameters of either oxycodone formulation were not changed with naltrexone administration under fasted conditions (point estimate T+/T (corresponding 90% confidence interval): C max : 103% (88 - 119%), AUC 0-t : 97% (87 - 108%), AUC: 97% (88 - 108%); point estimate R+/R (corresponding 90% confidence interval): C max : 104% (97 - 112%), AUC 0-t : 95% (88 - 102%), AUC: 94% (87 - 100%)). The safety and tolerability of both formulations was not qualitatively affected by naltrexone coadministration; however, treatment with naltrexone coadministration showed lower frequencies of adverse events. CONCLUSION Oral naltrexone does not affect the PK of oral oxycodone under fasted conditions. A naltrexone block can be applied in oxycodone PK trials to minimize adverse opioid effects.
.",2020,"The PK parameters of either oxycodone formulation were not changed with naltrexone administration under fasted conditions (point estimate T+/T (corresponding 90% confidence interval): C max : 103% (88 - 119%), AUC 0-t : 97% (87 - 108%), AUC: 97% (88 - 108%); point estimate R+/R (corresponding 90% confidence interval): C max : 104% (97 - 112%), AUC 0-t : 95% (88 - 102%), AUC: 94% (87 - 100%)).","['24 healthy subjects', 'healthy subjects', '12 subjects']","['naltrexone', 'Naltrexone', 'Oxygesic PR tablet (reference) with naltrexone (R+) and without naltrexone (R', 'new oxycodone prolonged-release (PR) tablet (test) with naltrexone (T+) and without naltrexone (T', 'naltrexone coadministration']","['frequencies of adverse events', 'safety and tolerability', 'Pharmacokinetics, safety, and tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",24.0,0.0949344,"The PK parameters of either oxycodone formulation were not changed with naltrexone administration under fasted conditions (point estimate T+/T (corresponding 90% confidence interval): C max : 103% (88 - 119%), AUC 0-t : 97% (87 - 108%), AUC: 97% (88 - 108%); point estimate R+/R (corresponding 90% confidence interval): C max : 104% (97 - 112%), AUC 0-t : 95% (88 - 102%), AUC: 94% (87 - 100%)).","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kleideiter', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Buller', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nemeth', 'Affiliation': ''}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Terlinden', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Rengelshausen', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203706'] 1964,32268801,"The Coronary ARteriogenesis with combined Heparin and EXercise therapy in chronic refractory Angina (CARHEXA) trial: A double-blind, randomized, placebo-controlled stress echocardiographic study.","BACKGROUND Coronary collateral circulation exerts protective effects on myocardial ischaemia due to coronary artery disease and can be promoted by exercise with heparin co-administration. Whether this arteriogenetic effect is accompanied by functional improvement of left ventricle during stress and lessening of angina symptoms remains unknown. AIMS To evaluate the anti-ischaemic efficacy of heparin plus exercise in coronary artery disease. METHODS In a prospective, single-centre, randomized, double-blind study we recruited 32 'no-option' patients (27 males; mean age 61 ± 8 years) with stable angina, exercise-induced ischaemia and coronary artery disease not suitable for revascularization. All underwent a two-week cycle of exercise (two exercise sessions per day, five days per week) and were randomized ( n  = 16 per group) to intravenous placebo (0.9% saline) versus unfractionated heparin (5.000 IU intravenously), 10 min prior to exercise. We assessed Canadian Cardiovascular Society angina class, stress electrocardiogram and echo parameters (wall motion score index) and computed tomography angiography for collaterals. RESULTS After two-week cycle, Canadian Cardiovascular Society class statistically decreased in both groups (heparin plus exercise group: 2.6 ± 0.7 to 1.9 ± 0.7, p  < 0.001, exercise group: 2.4 ± 0.7 to 2.1 ± 0.9, p  = 0.046). Only the heparin plus exercise group improved time-to-ST segment depression (before 270, 228-327 s vs . after 339, 280-360 s, p  = 0.012) and wall motion score index (before 1.38 ± 0.25 vs . after 1.28 ± 0.18, p  = 0.005). By multi-slice computed tomography angiography, collaterals improved in 12/15 (80%) in the heparin plus exercise group versus 2/16 (12.5%) in the exercise group ( p  < 0.001). CONCLUSION A two-week, 10-test cycle of heparin plus exercise is better than exercise in improving angina class, myocardial ischaemia and collaterals by computed tomography angiography.",2020,,[],"['placebo', 'Heparin and EXercise therapy']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.503596,,"[{'ForeName': 'Marija T', 'Initials': 'MT', 'LastName': 'Petrovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Djordjevic-Dikic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vojislav', 'Initials': 'V', 'LastName': 'Giga', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Boskovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vladan', 'Initials': 'V', 'LastName': 'Vukcevic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Cvetic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Mladenovic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Radmili', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Zeljko', 'Initials': 'Z', 'LastName': 'Markovic', 'Affiliation': 'Radiology Department, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Dobric', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Aleksandric', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Milorad', 'Initials': 'M', 'LastName': 'Tesic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Juricic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Nedeljkovic Beleslin', 'Affiliation': 'Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Stojkovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Miodrag C', 'Initials': 'MC', 'LastName': 'Ostojic', 'Affiliation': 'Institute for Cardiovascular Diseases Dedinje, Serbia.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Beleslin', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, School of Medicine, University of Belgrade, Serbia.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Picano', 'Affiliation': 'Institute of Clinical Physiology, CNR - Consiglio Nazionale Ricerche, Italy.'}]",European journal of preventive cardiology,['10.1177/2047487320915661'] 1965,32497956,Metacognitions about problematic Smartphone use: Development of a self-report measure.,"BACKGROUND AND AIMS Recent research has suggested that metacognitions may play a role across the spectrum of addictive behaviours, including problematic use of technological devices. Metacognitions associated with problematic Smartphone use (PSU) have been scarcely investigated and measures to assess these beliefs are not yet available. The goal of the present study was: (i) to develop the first self-report scale of metacognitions about Smartphone use; and (ii) to investigate its predictive validity with respect to PSU. METHODS Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F = 66.2%; mean age: 28.08 ± 9.81; age range: 15-70). An exploratory factor analysis was first performed in a randomly allocated subsample of 350 participants. A confirmative factor analysis was then computed on a second subsample of 351 participants to test the fit of the factor structure identified. RESULTS Findings revealed a 3-factor solution consisting of positive metacognitions concerning emotional and cognitive regulation, positive metacognitions concerning social advantages, and negative metacognitions about uncontrollability and cognitive harm of Smartphone use. Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire (MSUQ) factors were significantly associated to PSU independently of anxiety and depressive symptoms. CONCLUSIONS The MSUQ might be a promising self-report measure and further support research into the role of metacognition in technological addictions.",2020,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"['350 participants', 'Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F\xa0=\xa066.2%; mean age: 28.08\xa0±\xa09.81; age range: 15-70']",[],"['anxiety and depressive symptoms', 'Metacognitions about Smartphone Use Questionnaire']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",701.0,0.0366231,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Casale', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy. Electronic address: silvia.casale@unifi.it.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Caponi', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Fioravanti', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106484'] 1966,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8'] 1967,32499757,Aromatase Inhibitors Plus Weight Loss Improves the Hormonal Profile of Obese Hypogonadal Men Without Causing Major Side Effects.,"Objective: In obese men, the increased expression of the aromatase enzyme in adipose tissue leads to high conversion of androgens to estrogens contributing to hypogonadotropic hypogonadism (HHG). Our objective is to evaluate efficacy and safety of weight loss (WL) plus aromatase inhibitor (AI) therapy in severely obese men with HHG. We hypothesize that AI+WL will be more effective as compared to WL alone in improving the hormonal profile, thus muscle strength and symptoms of HHG (primary outcomes), with no significant adverse effects on lean mass, metabolic profile, and bone mineral density (secondary outcomes). Design: Randomized double-blind placebo-controlled pilot trial. Methods: Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old, were randomized to weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo (PBO+WL, n = 11) for 6 months. Inclusion criteria: total testosterone <300 ng/mL (average of 2 measurements), estradiol≥10.9 pg/ml, LH <9 IU/l. Symptoms of hypogonadism by questionnaires; muscle strength by Biodex dynamometer; body composition and bone mineral density by dual-energy X-ray absorptiometry; bone microarchitecture and finite element analysis by high resolution peripheral quantitative-computed tomography. Results: After 6 months of therapy, AI+WL group had higher testosterone ( p = 0.003) and lower estradiol ( p = 0.001) compared to PBO+WL. Changes in symptoms and muscle strength did not differ between groups. AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass. Total and LDL cholesterol reduced more in the PBO+WL group compared to AI+WL ( p = 0.03 for both), who experienced a minimal increase with unlikely meaningful clinical impact. Tibial trabecular bone area decreased more in PBO+WL than AI+WL group for which it remained stable ( p = 0.03). Conclusions: Although AI+WL is effective in reversing the hormonal profile of HHG in severely obese men without causing major side effects, it does not lead to greater improvements in muscle strength and symptoms of hypogonadism compared to WL alone. Clinical Trial Registration : www.ClinicalTrials.gov, identifier: NCT02959853.",2020,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"['severely obese men', 'severely obese men with HHG', 'obese men', 'Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old', 'Obese Hypogonadal Men']","['weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo', 'estradiol≥10.9 pg/ml, LH', 'weight loss (WL) plus aromatase inhibitor (AI) therapy', 'Aromatase Inhibitors Plus Weight Loss', 'placebo']","['lower estradiol', 'Tibial trabecular bone area', 'muscle strength and symptoms of hypogonadism', 'Total and LDL cholesterol', 'higher testosterone', 'lean mass, metabolic profile, and bone mineral density', 'Changes in symptoms and muscle strength']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0860850', 'cui_str': 'Oestradiol decreased'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",23.0,0.267862,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Colleluori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Vigevano', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Division of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, United States.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Research Pharmacy, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mediwala', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00277'] 1968,32500862,D-PLEX500: a local biodegradable prolonged release doxycycline-formulated bone graft for the treatment for peri-implantitis. A randomized controlled clinical study.,"OBJECTIVES In the present pilot, multicenter, randomized, single-blinded, controlled study, surgical treatment with or without the administration of D-PLEX500 (a biodegradable prolonged release local doxycycline formulated with β-tricalcium phosphate bone graft) was accessed for the treatment of peri-implantitis. METHOD AND MATERIALS Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation were randomly assigned, to adjunct D-PLEX500 placement group or to control group. Clinical and radiographic parameters were measured at 6 and 12 months. RESULTS Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants) were randomized to the test group and 13 (14 implants) to the control group. There was no difference in plaque scores between the groups. There was no difference in the changes of mean periodontal probing depth between the test and control groups between baseline and the 6-month follow-up, whereas statistically significant difference was observed after 12 months' follow-up when analyzed for all sites averaged. There was a statistically significant difference in the changes of clinical attachment levels and radiographic bone levels between the groups between baseline and 12 months. These improvements were demonstrated when analyzed at both implant and subject levels. Only D-PLEX500 treatment led to improved bone levels at both time points. The improvement in bone levels was significant in the D-PLEX500 treatment group already after 6 months, and further improved over the 12-month follow-up. Implants were lost only in the control group (14%). CONCLUSIONS D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions. The antibacterial component of the bone graft material might create favorable conditions that enable implant surface decontamination and soft and hard tissue healing over a prolonged period.",2020,D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions.,"['Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants', 'peri-implantitis', 'Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation']","['doxycycline-formulated bone graft', 'adjunct D-PLEX500 placement group or to control group', 'D-PLEX500']","['mean periodontal probing depth', 'bone levels', 'Clinical and radiographic parameters', 'plaque scores', 'clinical attachment levels and radiographic bone levels']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",27.0,0.0378858,D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions.,"[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Emanuel', 'Affiliation': ''}, {'ForeName': 'Eli E', 'Initials': 'EE', 'LastName': 'Machtei', 'Affiliation': ''}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Reichart', 'Affiliation': ''}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44629'] 1969,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM). METHODS In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. RESULTS At least 296 participants and approximately 75 peer supporters will be enrolled. DISCUSSION Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes. TRIAL REGISTRATION The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048'] 1970,32497927,Influence of type 1 diabetes on the postural control of women in the third gestational trimester.,"BACKGROUND Diabetes can cause biomechanical alterations that may be responsible for additional changes to those existing in a regular gestational period. The way a maternal body responds when affected by diabetes has not been clearly understood. This study aimed to describe the influence of type 1 diabetes on pregnant women's postural control. METHODS Forty pregnant women in their third gestational trimester were allocated in two equal groups - the control group and the type 1 diabetic group. The variables related to postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure). FINDINGS The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles. In the baropodometry, the anteroposterior distance and the amplitude of the center of pressure displacement with eyes open and closed were higher. INTERPRETATION The findings suggest that type 1 diabetes mellitus in the third trimester of pregnancy is associated with postural changes, a decrease in the active ankle range of motion and increase in the anteroposterior oscillation of the center of pressure, with negative repercussions for postural control.",2020,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","['Forty pregnant women in their third gestational trimester', 'women in the third gestational trimester', ""pregnant women's postural control""]",[],"['postural analysis, lower head protrusion and pelvic anteversion angles', 'postural control and balance were assessed using photogrammetry (head protrusion; cervical lordosis; thoracic kyphosis; lumbar lordosis; pelvic anteversion, knee flexion, tibiotarsal and foot inclination angles were measured), and baropodometry (anteroposterior and mediolateral distance trajectory of the center of pressure, amplitude and average speed of displacement of the center of pressure', 'cervical lordosis, thoracic kyphosis, and lumbar lordosis angles']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",[],"[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",40.0,0.0325439,"The results of the type 1 diabetic group showed, in the postural analysis, lower head protrusion and pelvic anteversion angles, while there was higher cervical lordosis, thoracic kyphosis, and lumbar lordosis angles.","[{'ForeName': 'Paola Marini', 'Initials': 'PM', 'LastName': 'Valerio', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: paola.marini@usp.br.'}, {'ForeName': 'Vanessa Ellen', 'Initials': 'VE', 'LastName': 'Gonçalves', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: vanessa.ellen.goncalves@usp.br.'}, {'ForeName': 'Catarina Clapis', 'Initials': 'CC', 'LastName': 'Zordão', 'Affiliation': 'Physical Therapy Course, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: catarina.zordao@usp.br.'}, {'ForeName': 'Monique Silva', 'Initials': 'MS', 'LastName': 'Rezende', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: moniquerezende@usp.br.'}, {'ForeName': 'Elaine Christine Dantas', 'Initials': 'ECD', 'LastName': 'Moisés', 'Affiliation': 'Postgraduate Program in Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: elainemoises@fmrp.usp.br.'}, {'ForeName': 'Elaine Caldeira de Olveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900, Ribeirão Preto, São Paulo CEP: 14049-900, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105062'] 1971,31808664,Changes in plasma volume before and after major abdominal surgery following stroke volume variation-guided fluid therapy: a randomized controlled trial.,"BACKGROUND The aim of intraoperative fluid therapy is to avoid both hypovolemia and hypervolemia; however, the patient's exact volume status is difficult to determine during surgery. Fluid optimization guided by stroke volume variation (SVV) has been widely used in patients undergoing major open abdominal surgery. The aim of this study was to evaluate the changes in plasma volume before and after surgery following SVV-guided fluid therapy. METHODS Patients were randomly allocated into one of two groups according to the SVV criteria for fluid administration during surgery. In the fixed SVV fluid strategy group, fluid was administered to maintain the SVV below 13%. In the individual SVV group, individual SVV values of each patient were maintained until the end of surgery. Plasma volume, body weight, and extracellular water (ECW) were measured before and after surgery. Plasma volume was estimated using the indocyanine green dilution technique. RESULTS A total of 118 patients were included. Median (25-75%) plasma volumes in the preoperative and postoperative period were 2.46 (2.20-2.88) L and 2.69 (2.33-3.12) L for the fixed SVV group (N.=57, P=0.133), respectively, and 2.56 (2.23-2.90) L and 2.89 (2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively. CONCLUSIONS Fluid administration during surgery to maintain SVV below 13% was effective for maintaining the preoperative plasma volume until the end of surgery in patients undergoing major open stomach or colorectal surgery. This result supports the validity of SVV-guided fluid therapy, which maintains the SVV value below 13%, in terms of maintaining patient volume status.",2020,"(2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively. ","['A total of 118 patients were included', 'patients undergoing major open stomach or colorectal surgery', 'patients undergoing major open abdominal surgery', 'Patients']","['SVV-guided fluid therapy', 'intraoperative fluid therapy', 'Fluid optimization guided by stroke volume variation (SVV']","['Plasma volume, body weight, and extracellular water (ECW', 'plasma volume', 'individual SVV values', 'Plasma volume', 'plasma volumes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",118.0,0.0506117,"(2.48-3.19) L for the individual SVV group (N.=61, P<0.001), respectively. ","[{'ForeName': 'Yong-Hun', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hye-Won', 'Initials': 'HW', 'LastName': 'Jang', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chan-Hye', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang-Mee', 'Initials': 'SM', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun-Kyoung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gyu-Jeong', 'Initials': 'GJ', 'LastName': 'Noh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea - nohgj@amc.seoul.kr.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.13952-1'] 1972,32502445,"Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial. METHODS The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211. FINDINGS Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). INTERPRETATION Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer. FUNDING MD Anderson Cancer Center and Medtronic.",2020,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). ","['patients with early stage cervical cancer', '496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group', 'patients with cervical cancer after', '631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group', '33 centres worldwide', 'Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy', 'Between Jan 31, 2008, and June 22, 2017']","['open versus minimally invasive radical hysterectomy (LACC', 'radical hysterectomy', 'open or minimally invasive radical hysterectomy']","['quality of life', 'validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical', 'mean FACT-Cx total scores', 'postoperative quality of life', 'Quality of life', 'disease-free survival at 4·5 years, and quality of life', 'mean FACT-Cx total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0346202', 'cui_str': 'Adenosquamous carcinoma of cervix'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",631.0,0.221146,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mfrumovitz@mdanderson.org.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, Colombia; Clínica de Oncología Astorga, Medellín, Colombia.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribero', 'Affiliation': 'Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rendon', 'Affiliation': 'Instituto de Cancerologia-Las Americas, Medellín, Colombia.'}, {'ForeName': 'Marcus Q', 'Initials': 'MQ', 'LastName': 'Bernadini', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, ON, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marquez', 'Affiliation': 'Hospital Israelita Albert Einstein, Centro de Oncologia e Hematologia, São Paulo, Brazil.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Zevallos', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Marcelo A', 'Initials': 'MA', 'LastName': 'Vieira', 'Affiliation': 'Barretos Cancer Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Land', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30081-4'] 1973,32503093,Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS.,"OBJECTIVE To assess the safety of ocrelizumab (OCR) shorter duration infusion in patients with MS. METHODS ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early stage relapsing-remitting MS received OCR 600 mg initially as two 300 mg IV infusions 2 weeks apart and subsequently as a single 3.5-hour 600 mg infusion every 24 weeks for 192 weeks. In ENSEMBLE PLUS, OCR 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration). The primary end point was the proportion of patients with infusion-related reactions (IRRs) after the first randomized dose (assessed during and up to 24 hours postinfusion). RESULTS From November 1, 2018, to September 27, 2019, 580 patients were randomized 1:1 to the conventional or shorter infusion group. After the first randomized dose, 67 of 291 patients (23.1%) in the conventional and 71 of 289 patients (24.6%) in the shorter infusion group experienced IRRs. Most IRRs were mild or moderate in both groups; one patient in each group experienced a severe IRR, and in both groups, 98.6% (136 of 138) of all IRRs resolved without sequelae. No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuation occurred. During the first randomized dose, 14 of 291 (4.8%) and 25 of 289 (8.7%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. CONCLUSION The frequency and severity of IRRs were similar between conventional and shorter OCR infusions. Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. CLASSIFICATION OF EVIDENCE This interventional study provides Class I evidence that the frequency and severity of IRRs were similar at the first randomized dose using OCR (600 mg) infusions of conventional and shorter duration in patients with relapsing-remitting MS. CLINICAL TRIAL IDENTIFIER NUMBER NCT03085810.",2020,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. ","['patients with MS', 'From November 1, 2018, to September 27, 2019, 580 patients', 'patients with relapsing-remitting MS', 'patients with early stage relapsing-remitting MS']","['OCR', 'conventional or shorter infusion group', 'Ocrelizumab', 'ocrelizumab (OCR']","['serious, life-threatening, or fatal', 'IRRs leading to infusion slowing/interruption', 'total infusion site stay time and lessens the overall patient and site staff burden', 'IRRs', 'severe IRR', 'proportion of patients with infusion-related reactions (IRRs', 'frequency and severity of IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",580.0,0.17746,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. ","[{'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'From the Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany. hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000807'] 1974,32503194,Acupuncture Treatment Modulates the Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems in Patients with Chronic Low Back Pain.,"Chronic low back pain (cLBP) is a common disorder with unsatisfactory treatment options. Acupuncture has emerged as a promising method for treating cLBP. However, the mechanism underlying acupuncture remains unclear. In this study, we investigated the modulation effects of acupuncture on resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA) in patients with cLBP. Seventy-nine cLBP patients were recruited and assigned to four weeks of real or sham acupuncture. Resting state functional magnetic resonance imaging data were collected before the first and after the last treatment. Fifty patients completed the study. We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture. We also found that real acupuncture can increase VTA/PAG rsFC with the amygdala, and the increased rsFC was associated with decreased pain bothersomeness scores. Baseline PAG-amygdala rsFC could predict four-week treatment response. Our results suggest that acupuncture may simultaneously modulate the rsFC of key regions in the descending pain modulation (PAG) and reward systems (VTA), and the amygdala may be a key node linking the two systems to produce antinociceptive effects. Our findings highlight the potential of acupuncture for chronic low back pain management.",2020,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","['Patients with Chronic Low Back Pain', 'Fifty patients completed the study', 'patients with cLBP', 'Seventy-nine cLBP patients']","['acupuncture', 'real or sham acupuncture', 'Acupuncture']","['remission of pain bothersomeness', 'pain relief', 'resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA', 'Chronic low back pain (cLBP', 'pain bothersomeness scores', 'Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems', 'VTA/PAG rsFC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0175405', 'cui_str': 'Ventral Tegmental Area of Tsai'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",79.0,0.121085,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA 15206, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02467, USA.""}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}]",Journal of clinical medicine,['10.3390/jcm9061719'] 1975,32503243,Randomized Trial of General Strength and Conditioning Versus Motor Control and Manual Therapy for Chronic Low Back Pain on Physical and Self-Report Outcomes.,"Exercise and spinal manipulative therapy are commonly used for the treatment of chronic low back pain (CLBP) in Australia. Reduction in pain intensity is a common outcome; however, it is only one measure of intervention efficacy in clinical practice. Therefore, we evaluated the effectiveness of two common clinical interventions on physical and self-report measures in CLBP. Participants were randomized to a 6‑month intervention of general strength and conditioning (GSC; n = 20; up to 52 sessions) or motor control exercise plus manual therapy (MCMT; n =20; up to 12 sessions). Pain intensity was measured at baseline and fortnightly throughout the intervention. Trunk extension and flexion endurance, leg muscle strength and endurance, paraspinal muscle volume, cardio‑respiratory fitness and self-report measures of kinesiophobia, disability and quality of life were assessed at baseline and 3- and 6-month follow-up. Pain intensity differed favoring MCMT between-groups at week 14 and 16 of treatment (both, p = 0.003), but not at 6-month follow‑up. Both GSC (mean change (95%CI): -10.7 (-18.7, -2.8) mm; p = 0.008) and MCMT (-19.2 (-28.1, -10.3) mm; p < 0.001) had within-group reductions in pain intensity at six months, but did not achieve clinically meaningful thresholds (20mm) within- or between‑group. At 6-month follow-up, GSC increased trunk extension (mean difference (95% CI): 81.8 (34.8, 128.8) s; p = 0.004) and flexion endurance (51.5 (20.5, 82.6) s; p = 0.004), as well as leg muscle strength (24.7 (3.4, 46.0) kg; p = 0.001) and endurance (9.1 (1.7, 16.4) reps; p = 0.015) compared to MCMT. GSC reduced disability (-5.7 (‑11.2, -0.2) pts; p = 0.041) and kinesiophobia (-6.6 (-9.9, -3.2) pts; p < 0.001) compared to MCMT at 6‑month follow-up. Multifidus volume increased within-group for GSC ( p = 0.003), but not MCMT or between-groups. No other between-group changes were observed at six months. Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months. These results show that GSC may provide a more diverse range of treatment effects compared to MCMT.",2020,"Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months.",['chronic low back pain (CLBP) in Australia'],"['GSC', 'Exercise and spinal manipulative therapy', '6‑month intervention of general strength and conditioning (GSC; n = 20; up to 52 sessions) or motor control exercise plus manual therapy (MCMT', 'General Strength and Conditioning Versus Motor Control and Manual Therapy']","['MCMT', 'endurance', 'Multifidus volume', 'flexion endurance', 'pain intensity', 'Trunk extension and flexion endurance, leg muscle strength and endurance, paraspinal muscle volume, cardio‑respiratory fitness and self-report measures of kinesiophobia, disability and quality of life', 'Pain intensity', 'Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia', 'kinesiophobia', 'leg muscle strength', 'GSC reduced disability', 'trunk extension']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1621352', 'cui_str': 'DNMT1 Enzyme'}]","[{'cui': 'C1621352', 'cui_str': 'DNMT1 Enzyme'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0653155,"Overall, GSC improved trunk endurance, leg muscle strength and endurance, self-report disability and kinesiophobia compared to MCMT at six months.","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Tagliaferri', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Clint T', 'Initials': 'CT', 'LastName': 'Miller', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Jon J', 'Initials': 'JJ', 'LastName': 'Ford', 'Affiliation': 'Advance HealthCare, 157 Scoresby Rd, Boronia, VIC 3155, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Hahne', 'Affiliation': 'Low Back Research Team, College of Science, Health & Engineering, La Trobe University, Bundoora, VIC 3083, Australia.'}, {'ForeName': 'Luana C', 'Initials': 'LC', 'LastName': 'Main', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Connell', 'Affiliation': 'Imaging@Olympic Park, AAMI Park, 60 Olympic Boulevard, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Simson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Owen', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Belavy', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, VIC 3220, Australia.'}]",Journal of clinical medicine,['10.3390/jcm9061726'] 1976,32503294,A Mixed Methods Evaluation of a Randomized Control Trial to Evaluate the Effectiveness of the Pure Prairie Living Program in Type 2 Diabetes Participants.,"The primary objective of this randomized control trial was to evaluate the effectiveness of the Pure Prairie Living Program (PPLP) in a primary care setting. Adults with type 2 diabetes were randomized into intervention (PPLP, n = 25) and wait-listed controls (CON, n = 24). The PPLP group participated in education sessions. The intervention yielded no significant within-group changes in HbA1c at three-month (-0.04 (-0.27 to 0.17) and -0.15 (-0.38 to 0.08)) or six-month (-0.09 (-0.41 to 0.22) and 0.06 (-0.26 to 0.38)) follow ups in either CON or PPLP groups, respectively. Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison. No changes in diabetes self-efficacy scores were detected. In the qualitative analysis, participants described the program as clear and easy to understand. Knowledge acquired influenced their everyday decision making but participants faced barriers that prevented them from fully applying what they learned. Healthcare professionals enjoyed delivering the program but described the ""back-stage"" workload as detrimental. In conclusion, while some positive effects of the PPLP intervention were observed, they were not comparable to those previously attained by our group in an academic setting or to what the guidelines recommend, which reflects the challenge of translating lifestyle intervention to real-world settings.",2020,Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison.,"['Type 2 Diabetes Participants', 'Adults with type 2 diabetes']","['Pure Prairie Living Program (PPLP', 'PPLP', 'Pure Prairie Living Program']","['Dietary adherence scores', 'diabetes self-efficacy scores']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0442534', 'cui_str': 'Prairie'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0301551,Dietary adherence scores improved in the PPLP group ( p < 0.05) at three and six months but were not different in the between-group comparison.,"[{'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Archundia-Herrera', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}, {'ForeName': 'Fatheema B', 'Initials': 'FB', 'LastName': 'Subhan', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB T6G 2T4, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sakowsky', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Watkins', 'Affiliation': 'Sherwood Park Primary Care Network, 150 Broadway Crescent, Suite 108, Sherwood Park, AB T8H 0V3, Canada.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Chan', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science, University of Alberta, 6-002 Li Ka Shing Centre for Health Innovation Research, Edmonton, AB T6G 2E1, Canada.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020153'] 1977,32503652,The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes.,"BACKGROUND The objective of this study was to investigate the effects of Anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in patients with type 2 diabetes. MATERIALS AND METHODS In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3 g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms were measured in all of the subjects at baseline and postintervention. RESULTS The dill powder supplementation significantly decreased the mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde in the intervention group in comparison with the baseline measurements (P < 0.05). Furthermore, the mean serum levels of high-density lipoprotein and total antioxidant capacity were significantly increased in the intervention group in comparison with the baseline measurement (P < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde were significantly lower in the intervention group than in the control group (P < 0.05). In addition, the mean changes in high-density lipoprotein were significantly higher in the intervention group than in the control group (P < 0.05). CONCLUSION Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative and gastrointestinal symptoms in patients with type 2 diabetes. TRIAL REGISTRATION Iran Clinical Trials Registry: IRCT20120704010181N12. Registered on 12 May 2018.",2020,Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01).,"['42 patients with type 2 diabetes', 'patients with type 2 diabetes']","['Anethum graveolens (dill) powder supplementation', '3\u2009g/day dill powder or placebo']","['glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms', 'clinical and metabolic status', 'mean changes in high-density lipoprotein', 'Colonic motility disorder', 'glycemic, lipid, stress oxidative and gastrointestinal symptoms', 'mean serum levels of high-density lipoprotein and total antioxidant capacity', 'Fasting blood sugar, insulin, homeostatic model assessment of insulin resistance, lipid profile, high-sensitivity C-reactive protein, total antioxidant capacity, malondialdehyde and gastrointestinal symptoms', 'mean changes in insulin, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde', 'mean serum levels of insulin, homeostatic model assessment of insulin resistance, low-density lipoprotein cholesterol, total cholesterol and malondialdehyde']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1260544', 'cui_str': 'Dill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",42.0,0.0588679,Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Zakerkish', 'Affiliation': 'Health Research Institute, Diabetes Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Borazjani', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi Angali', 'Affiliation': 'Department of Biostatistic, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Amoochi Foroushani', 'Affiliation': 'Health Research Institute, Diabetes Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. golnazamoochi@gmail.com.'}]",Trials,['10.1186/s13063-020-04401-3'] 1978,32503654,Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial.,"BACKGROUND Recent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no consistent international treatment guidelines supporting a ketogenic diet as an adjuvant therapy for metastatic breast cancer. Therefore, this trial was designed to observe whether irinotecan with a ketogenic diet can promote sensitivity to chemotherapy and remit target lesions in locally recurrent or metastatic Her-2-negative breast cancer patients. METHODS/DESIGN This trial aims to recruit 518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China. All patients will be randomly assigned into the combined intervention group (n = 259) or the control group (n = 259), followed by treatment with irinotecan + ketogenic diet or irinotecan + normal diet, respectively. The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness. The endpoints will be evaluated at baseline (before drug administration), during treatment, 4 weeks after treatment completion, and every 3months (beginning 2 months after treatment completion). DISCUSSION This trial attempts to investigate whether irinotecan treatment with a ketogenic diet for locally recurrent or metastatic breast cancer among women in northeast China can enhance the disease's sensitivity to chemotherapy and reduce target lesions. TRIAL REGISTRATION Chinese Clinical Trial Registry, ID: ChiCTR1900024597. Registered on 18 July 2019. Protocol Version: 1.1, 24 February 2017.",2020,"The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness.","['518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China', 'locally recurrent or metastatic Her-2-negative breast cancer patients', 'cancer patients', 'patients with locally recurrent or metastatic Her-2-negative breast cancer', 'locally recurrent or metastatic breast cancer among women in northeast China']","['chemotherapy and radiotherapy', 'ketogenic diet', 'irinotecan + ketogenic diet or irinotecan + normal diet, respectively', 'irinotecan', 'irinotecan with a ketogenic diet']","['sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",518.0,0.103465,"The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Ming-Xi', 'Initials': 'MX', 'LastName': 'Jing', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Jia', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ying', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Xiang-Yu', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, 44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning Province, 110042, P.R. China. jianong@126.com.'}]",Trials,['10.1186/s13063-020-04429-5'] 1979,32503657,"The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES A variety of possible mechanisms can make the nucleic acid test of patients who meet the discharge conditions positive again, including reinfection, reactivation of the original virus, lack of strict discharge criteria, new infection, and so on. Different reasons will correspond to different prevention and control measures. We will enroll patients who are discharged after treatment, whose nucleic acid test has changed from negative to positive during the screening visit, regardless of the severity of the symptoms, to investigate the mechanism, clinical outcome and therapeutic efficacy with Favipiravir patients with Corona virus Disease 2019. Favipiravir is an anti-viral agent that selectively and potently inhibits the RNA-dependent RNA polymerase, it has been used for treatment of some life-threatening infections such as Ebola virus, Lassa virus and rabies. Its therapeutic efficacy has been proven in these diseases. TRIAL DESIGN This is a multi-center, two arm, open label, parallel group, randomized controlled trial. PARTICIPANTS Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge), The nucleic acid test of COVID-19 is positive in any one of the following samples: sputum, throat swabs, blood, feces or other specimens. Regardless of whether or not they had symptoms and the severity of symptoms.4.Volunteer to participate in the research and sign the Informed Consent Form. EXCLUSION CRITERIA 1.Allergic to Favipiravjr;2.Pregnant or lactating women3.Uncontrolled diseases of the blood and cardiovascular system, liver or kidney.4.History of mental disorders, drug abuse or dependence;5.Researchers consider it inappropriate for adults to participate;6.Participating in other clinical studies. Loss to Follow up: Cases that do not complete the clinical trial program will be regarded as lost to follow up. Including the withdrawal of patients by themselves (such as poor compliance, etc.), or the withdrawal of patients ordered by the researcher (those who need other drugs which affect the judgment of the curative effect, and those who need to stop taking drugs for severe adverse events) Study setting: The participating hospitals are some of the designated hospitals that have been or may be admitting patients who meet the eligibility criteria, mainly in Hubei, Shenzhen, Anhui and Beijing. Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei; The Second People's Hospital of Fuyang, Anhui; The First Affiliated Hospital of USTC, Anhui; Beijing Youan Hospital, Beijing; Capital Medical University Beijing Institute of Hepatology, Beijing; Ezhou Hospital of Traditional Chinese Medicine, Hubei; Zhongnan Hospital of Wuhan University, Hubei; The Fifth Hospital of ShiJiazhuang, Hebei; Jinan Infectious Diseases Hospital, Shandong; Public Health Clinical Center of Chengdu, Sichuan; Wuxi No.5 People's Hospital, Jiangsu; The Third People's Hospital of Shenzhen, Guangdong; The First Affiliated Hospital of Bengfu Medical College, AnHui. INTERVENTION AND COMPARATOR Favipiravir group (experimental): Favipiravir 1600mg each dose, twice a day on the 1st day; 600mg each dose, twice a day from the 2nd to the 7th day, Oral administration, the maximum number of days taken will be no more than 14 days plus routine treatment for COVID-19. Regular treatment group (control): Treatments other than Antiviral drugs can be given. Routine treatment for patients with the corona virus will be administered, this includes oxygen therapy, drugs that reduced phlegm and relieve cough, including thymosin, proprietary Chinese medicine, etc. MAIN OUTCOMES: Primary Outcome Measures: Viral nucleic acid test negative [Time Frame: 5 months]: Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours). SECONDARY OUTCOME MEASURES Clinical cure [Time Frame: 5 months]: 1.Body temperature returned to normal for more than 3 days;2.Lung image improved.3.Clinical manifestation improved;4.The viral nucleic acid test of respiratory specimens was negative for two consecutive times (sampling time interval of at least 24 hours). RANDOMIZATION The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1. In this study, block randomization will be used, in blocks of 6. BLINDING (MASKING) This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment. NUMBERS TO BE RANDOMISED 210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140): 1(regular treatment group, n=70). TRIAL STATUS Protocol version number 3.0, 10 th April 2020 First Patient, first visit 17 th March 2020; recruitment end date anticipated June 1, 2020. TRIAL REGISTRATION ClinicalTrials.gov, NCT04333589, April 3, 2020. Registered April 3, 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","['patients with Corona Virus Disease 2019', 'patients with the corona virus', 'Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei', 'patients with Corona virus Disease 2019', ""Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge"", 'Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours', '210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140', 'Protocol version number 3.0, 10 th April 2020']","['Favipiravir', 'Regular treatment group (control']","['Clinical cure', 'severe adverse events', 'Viral nucleic acid test negative']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0854545,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","[{'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. haohong_pufh@bjmu.edu.cn.'}]",Trials,['10.1186/s13063-020-04430-y'] 1980,32503661,Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2).,"BACKGROUND The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools. METHODS We will conduct a hybrid type 2 stepped wedge pragmatic cluster randomized clinical trial to evaluate a guideline-informed enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) care model. Teams of clinicians at five hospitals that care for patients with various cancers will be randomly assigned in steps to the E2C2 intervention. The E2C2 intervention will have two levels of care: level 1 will offer low-touch, automated self-management support for patients reporting moderate sleep disturbance, pain, anxiety, depression, and energy deficit symptoms or limitations in physical function (or both). Level 2 will offer nurse-managed collaborative care for patients reporting more intense (severe) symptoms or functional limitations (or both). By surveying and interviewing clinical staff, we will also evaluate whether the use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 technologies improves patient and clinical outcomes. Finally, we will conduct a mixed methods evaluation to identify disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer. DISCUSSION The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients. Since discrete EHR-imbedded algorithms drive defining aspects of the intervention, the approach can be efficiently disseminated and updated by specifying and modifying these centralized EHR algorithms. TRIAL REGISTRATION ClinicalTrials.gov, NCT03892967. Registered on 25 March 2019.",2020,"The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients.","['elderly and rural-dwelling patients with cancer', 'Teams of clinicians at five hospitals that care for patients with various cancers', 'cancer patients']","['enhanced EHR-facilitated cancer symptom control (E2C2', 'E2C2 intervention']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.151335,"The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients.","[{'ForeName': 'Lila J', 'Initials': 'LJ', 'LastName': 'Finney Rutten', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. rutten.lila@mayo.edu.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Chlan', 'Affiliation': 'Department of Nursing, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Griffin', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jeph', 'Initials': 'J', 'LastName': 'Herrin', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Leppin', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Deirdre R', 'Initials': 'DR', 'LastName': 'Pachman', 'Affiliation': 'Center for Palliative Care, Mayo Clinic, Minnesota, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Ridgeway', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Parvez A', 'Initials': 'PA', 'LastName': 'Rahman', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Curtis B', 'Initials': 'CB', 'LastName': 'Storlie', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cheville', 'Affiliation': 'Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}]",Trials,['10.1186/s13063-020-04335-w'] 1981,32503662,Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) when compared to standard care. Furthermore, we hypothesize that early treatment with hydroxychloroquine sulphate is associated with more rapid resolve of clinical symptoms as assessed by the National Early Warning Score 2 (NEWS2), decreased admission rate to intensive care units and mortality, and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide). TRIAL DESIGN The study is a two-arm, open label, pragmatic randomised controlled group sequential adaptive trial designed to assess the effect on viral loads and clinical outcome of hydroxychloroquine sulphate therapy in addition to standard care compared to standard care alone in patients with established Covid-19. By utilizing resources already paid for by the hospitals (physicians and nurses in daily clinical practice), this pragmatic trial can include a larger number of patients over a short period of time and at a lower cost than studies utilizing traditional randomized controlled trial designs with an external study organization. The pragmatic approach will enable swift initiation of randomisation and allocation to treatment. PARTICIPANTS Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway. Electronic real-time surveillance of laboratory reports from the Department of Microbiology will be examined regularly for SARS-CoV-2 positive subjects. All of the following conditions must apply to the prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations. Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5) Prolonged corrected QT interval (>450 ms). Clinical data, including standard hospital biochemistry, medical therapy, vital signs, NEWS2, and microbiology results (including blood culture results and reverse transcriptase polymerase chain reaction [RT-PCR] for other upper airway viruses), will be automatically extracted from the hospital electronic records and merged with the study specific database. INTERVENTION AND COMPARATOR Included patients will be randomised in a 1:1 ratio to (1) standard care with the addition of 400 mg hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone. MAIN OUTCOMES The primary endpoint of the study is the rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization and administration of drug for the intervention arm. Secondary endpoints include change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation [3] Hospitalised, on non-invasive ventilation or high flow oxygen devices [4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization. RANDOMISATION Eligible patients will be allocated in a 1:1 ratio, using a computer randomisation procedure. The allocation sequence has been prepared by an independent statistician. BLINDING (MASKING) Open label randomised controlled pragmatic trial without blinding, no active or placebo control. The virologist assessing viral load in the oropharyngeal samples and the statistician responsible for analysis of the data will be blinded to the treatment allocation for the statistical analyses. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) This is a group sequential adaptive trial where analyses are planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to intervention and standard care and 101 patients allocated to standard care alone). TRIAL STATUS Protocol version 1.3 (March 26, 2020). Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020. Study recruitment is anticipated to be completed by July 2020. TRIAL REGISTRATION ClinicalTrials.gov number, NCT04316377. Trial registered March 20, 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Prolonged corrected QT interval (>450 ms).,"['Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020', 'prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations', 'moderately severe hospitalised patients with coronavirus disease 2019', 'patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5', '4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization', 'hospitalised patients with coronavirus disease 2019 (Covid-19', 'patients with established Covid-19', 'Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway', 'planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to', 'Norwegian Coronavirus Disease 2019']","['hydroxychloroquine sulphate therapy', 'non-invasive ventilation or high flow oxygen devices', 'intervention and standard care and 101 patients allocated to standard care alone', 'placebo control', 'hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone', 'hydroxychloroquine sulphate']","['rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR', 'Prolonged corrected QT interval', 'change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation', 'virological clearance rate']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0455567', 'cui_str': 'H/O: psoriasis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}]","[{'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699177', 'cui_str': 'Plaquenil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",,0.36269,Prolonged corrected QT interval (>450 ms).,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Trials,['10.1186/s13063-020-04420-0'] 1982,32507157,Influence of the order of aerobic and resistance exercise on hemodynamic responses and arterial stiffness in young normotensive individuals.,"AIMS To investigate the effects of a combination of aerobic and resistance exercises and the inverse sequence on the hemodynamic parameters and indicators of arterial stiffness in healthy young adult subjects. METHODS Fifteen subjects were randomized in a crossover procedure according to two experimental conditions: combined aerobic exercise (30 min of treadmill running, 75-80% - peak VO 2 ) followed by resistance exercise (5 exercises, 3 sets - 10 RM) (AR) or vice versa (RA). Data of the hemodynamic parameters and arterial stiffness were obtained at baseline and after exercise (post-10, post-20, and post-30 min). Two-way ANOVA for repeated measurements was performed with the Newman-Keuls post-hoc. The significance level adopted was p < 0.05. RESULTS The results of the two-way ANOVA for repeated measures were not statistically significant for brachial and central systolic and diastolic blood pressure, respectively, or arterial stiffness indicators: reflected wave indicators and pulse wave velocity (P > 0.05). Statistically significant interactions were observed before and after the exercise sessions for heart rate and rate pressure product (P = < 0.001). CONCLUSION The performance order of aerobic exercise followed by resistance exercise (AR) and the reverse order (RA) present similar changes in blood pressure (BP) and arterial stiffness. However, resistance exercise before aerobic exercise promotes increases in heart rate and rate product pressure.",2020,"Statistically significant interactions were observed before and after the exercise sessions for heart rate and rate pressure product (P = < 0.001). ","['healthy young adult subjects', 'young normotensive individuals', 'Fifteen subjects']","['combined aerobic exercise (30\u202fmin of treadmill running, 75-80% - peak VO 2 ) followed by resistance exercise (5 exercises, 3 sets - 10 RM) (AR) or vice versa (RA', 'aerobic and resistance exercises', 'aerobic exercise followed by resistance exercise (AR) and the reverse order (RA', 'aerobic and resistance exercise']","['blood pressure (BP) and arterial stiffness', 'heart rate and rate product pressure', 'hemodynamic responses and arterial stiffness', 'brachial and central systolic and diastolic blood pressure', 'heart rate and rate pressure product']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",15.0,0.0449737,"Statistically significant interactions were observed before and after the exercise sessions for heart rate and rate pressure product (P = < 0.001). ","[{'ForeName': 'Wagner Jorge Ribeiro', 'Initials': 'WJR', 'LastName': 'Domingues', 'Affiliation': 'Federal University of Amazonas, Institute of Social Sciences, Education and Animal Science, Parintins Macurany Road, 1805, Parintins, Amazonas, 69152-240, Brazil. Electronic address: wjrdomingues@ufam.edu.br.'}, {'ForeName': 'Antonio Henrique', 'Initials': 'AH', 'LastName': 'Germano-Soares', 'Affiliation': 'Associated Graduate Program in Physical Education UPE/UFPB, University of Pernambuco, Brazil. Electronic address: henrique_soares1991@hotmail.com.'}, {'ForeName': 'Bruno Remígio', 'Initials': 'BR', 'LastName': 'Cavalcante', 'Affiliation': 'Associated Graduate Program in Physical Education UPE/UFPB, University of Pernambuco, Brazil. Electronic address: br_13remigio@outlook.com.'}, {'ForeName': 'Rinaldo Ramos', 'Initials': 'RR', 'LastName': 'Matias da Silva', 'Affiliation': 'Nove de Julho University - UNINOVE, Sao Paulo, Brazil. Electronic address: rinaldo.ramos@outlook.com.'}, {'ForeName': 'Pollyana Mayara', 'Initials': 'PM', 'LastName': 'Nunhes', 'Affiliation': 'State University of Maringa - UEM, Maringa, Brazil. Electronic address: polly_nunhes@hotmail.com.'}, {'ForeName': 'Gustavo Marçal', 'Initials': 'GM', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'University Institute of Maia - ISMAI, Porto, Portugal. Electronic address: gugonsilva@gmail.com.'}, {'ForeName': 'Ewertton', 'Initials': 'E', 'LastName': 'Bezerra', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Federal University of Amazonas, Manaus, Amazonas, Brazil. Electronic address: ewsbezerra@yahoo.com.br.'}, {'ForeName': 'Nórton Luís', 'Initials': 'NL', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Sport, University of Porto, Portugal. Electronic address: nloedfisica@gmail.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Sport, University of Porto, Porto, Portugal. Electronic address: joliveira@fade.up.pt.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.09.005'] 1983,32507159,Impact of hippotherapy for balance improvement and flexibility in elderly people.,"INTRODUCTION The decrease in functional ability, strength, balance, flexibility, agility, and coordination owing to neurological and muscular changes is one of the characteristic features of the human aging process. Hippotherapy has been highlighted as a therapeutic approach with physical and psychological benefits for this section of the population. However, the effects of hippotherapy in elderly people need to be further studied by assessing their balance and flexibility. METHODS Thirty elderly people were recruited and divided into two groups; 15 in the Hippotherapy Group (HG), and 15 in the control group (CG) (aged 66.07 ± 5.80 and 68.47 ± 5.85 years, respectively). The HG received ten 30-min sessions of hippotherapy once a week. Assessment included the Berg Balance Scale (BBS), the Timed Up and Go test (TUG), the Functional Reach Test (FRT)and the Sit-and-Reach Test with the Well's box before the first and after the tenth session of hippotherapy; and the Sit-and-Reach Test before and after each session. RESULTS The HG demonstrated a significant difference in the TUG test execution time and the FRT scores before and after the hippotherapy sessions (p = 0.036, p = 0.030, respectively), indicating an improvement in functional range. The examination of flexibility with the Wells's box also revealed a significant difference in the rates (cm) before and after 10 sessions of the hippotherapy for the HG (p = 0.033). CONCLUSIONS The present findings showthat hippotherapy improved elderly people's functional mobility, dynamic balance, and flexibility. These results will guide professionals who treat this population.",2020,"The HG demonstrated a significant difference in the TUG test execution time and the FRT scores before and after the hippotherapy sessions (p = 0.036, p = 0.030, respectively), indicating an improvement in functional range.","['Thirty elderly people were recruited and divided into two groups; 15 in the Hippotherapy Group (HG), and 15 in the control group (CG) (aged 66.07\u202f±\u202f5.80 and 68.47\u202f±\u202f5.85 years, respectively', 'elderly people']","['Hippotherapy', 'hippotherapy']","['functional range', 'TUG test execution time and the FRT scores', 'functional ability, strength, balance, flexibility, agility, and coordination owing to neurological and muscular changes', ""Berg Balance Scale (BBS), the Timed Up and Go test (TUG), the Functional Reach Test (FRT)and the Sit-and-Reach Test with the Well's box"", ""elderly people's functional mobility, dynamic balance, and flexibility""]","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",30.0,0.0177894,"The HG demonstrated a significant difference in the TUG test execution time and the FRT scores before and after the hippotherapy sessions (p = 0.036, p = 0.030, respectively), indicating an improvement in functional range.","[{'ForeName': 'Luanna Honorato', 'Initials': 'LH', 'LastName': 'Diniz', 'Affiliation': 'Concentration Area Human Pathology - Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: luannahd@hotmail.com.'}, {'ForeName': 'Edneia Corrêa', 'Initials': 'EC', 'LastName': 'de Mello', 'Affiliation': 'Concentration Area Human Pathology - Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: edneia.mello38@gmail.com.'}, {'ForeName': 'Mariane Fernandes', 'Initials': 'MF', 'LastName': 'Ribeiro', 'Affiliation': 'Concentration Area Human Pathology - Universidade Federal do TriânguloMineiro - UFTM, PhysicalTherapistat Associação de Pais e Amigos dos Excepcionais de Uberaba - APAE, Uberaba, Minas Gerais, Brazil. Electronic address: maryanefernandes@yahoo.com.br.'}, {'ForeName': 'Janaine Brandão', 'Initials': 'JB', 'LastName': 'Lage', 'Affiliation': 'Concentration Area Human Pathology - Universidade Federal do TriânguloMineiro - UFTM, PhysicalTherapistat Associação de Pais e Amigos dos Excepcionais de Uberaba - APAE, Uberaba, Minas Gerais, Brazil. Electronic address: ja.bl@terra.com.br.'}, {'ForeName': 'Domingos Emanuel', 'Initials': 'DE', 'LastName': 'Bevilacqua Júnior', 'Affiliation': 'Concentration Area Human Pathology - Universidade Federal do TriânguloMineiro - UFTM, PhysicalTherapistat Associação de Pais e Amigos dos Excepcionais de Uberaba - APAE, Uberaba, Minas Gerais, Brazil. Electronic address: domingos_fisio@hotmail.com.'}, {'ForeName': 'Alex Abadio', 'Initials': 'AA', 'LastName': 'Ferreira', 'Affiliation': 'Associação de Pais e Amigos dos Excepcionais de Uberaba - APAE, Uberaba, Minas Gerais, Brazil. Electronic address: alexabferreira@hotmail.com.'}, {'ForeName': 'Mara Lúcia da Fonseca', 'Initials': 'MLDF', 'LastName': 'Ferraz', 'Affiliation': 'Concentration Area General Pathology, Biologist and Lecturer at Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: mara@patge.uftm.edu.br.'}, {'ForeName': 'Rodrigo César', 'Initials': 'RC', 'LastName': 'Rosa', 'Affiliation': 'Senior Lecturer of the Discipline of Human Anatomy -Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: rodrigo.rosa@uftm.edu.br.'}, {'ForeName': 'Vicente de Paula Antunes', 'Initials': 'VPA', 'LastName': 'Teixeira', 'Affiliation': 'Concentration Area General Pathology, Senior Lecturer of the Discipline of General Pathology - Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: vicenteantunes54@gmail.com.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Espindula', 'Affiliation': 'Concentration Area Human Pathology e Post Doctorate Student and Lecturer at Universidade Federal do TriânguloMineiro - UFTM, Uberaba, Minas Gerais, Brazil. Electronic address: anapaulaespindula@yahoo.com.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.10.002'] 1984,32507160,"The effect of aerobic and resistance exercise training on the health related quality of life, physical function, and muscle strength among hemodialysis patients with Type 2 diabetes.","INTRODUCTION Diabetic patients who undergo hemodialysis commonly suffer from reduction of both exercise capacity and muscle strength. These factors may have a negative effect on health related quality of life (HRQoL) and physical function. We investigated the effect of aerobic and resistance exercise training on the HRQoL, physical function, and muscle strength among hemodialysis patients with Type 2 diabetes. METHODS Twenty-eight diabetic patients who were on hemodialysis in the Milad Hospital (Tehran, Iran) were recruited for the study. Subjects were randomized into control (n = 13) and exercise training groups (n = 15). The exercise training group performed combined aerobic and resistance exercise training at moderate intensity (11-15/20 on the Borg scale) during hemodialysis treatment, 3 times a week for 8 weeks. The primary outcomes consisted of physical function measured by a 6-min walk test (6MWT), HR-QoL measured by the Short Form Health Survey (SF-36), and lower limb muscle strength measured using a hand-held Digital Dynamometer. RESULTS The 6MWT distance increased significantly in the exercise training group (36%). Bilateral hip flexor strength (right, 24.5%; left, 30.4%) and abductor strength (right, 27.6%; left, 25.2%) decreased significantly in the non-exercising control group but no significant change was found in the exercise group (P > 0.05). There were no significant changes in any of the 8 generic subscales of HR-QoL neither in the exercise training group nor controls following an 8- week study. CONCLUSIONS 8 weeks of combined aerobic-resistance exercise training among diabetic hemodialysis patients seem to be effective in improvement of physical function and lower limb muscle strength.",2020,"There were no significant changes in any of the 8 generic subscales of HR-QoL neither in the exercise training group nor controls following an 8- week study. ","['Diabetic patients who undergo hemodialysis commonly suffer from reduction of both exercise capacity and muscle strength', 'hemodialysis patients with Type 2 diabetes', 'diabetic hemodialysis patients', 'Twenty-eight diabetic patients who were on hemodialysis in the Milad Hospital (Tehran, Iran) were recruited for the study']","['exercise training', 'combined aerobic-resistance exercise training', 'aerobic and resistance exercise training', 'exercise training group performed combined aerobic and resistance exercise training']","['6MWT distance', 'physical function measured by a 6-min walk test (6MWT), HR-QoL measured by the Short Form Health Survey (SF-36), and lower limb muscle strength measured using a hand-held Digital Dynamometer', 'abductor strength', 'Bilateral hip flexor strength', 'generic subscales of HR-QoL', 'physical function and lower limb muscle strength', 'HRQoL, physical function, and muscle strength', 'health related quality of life, physical function, and muscle strength']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",28.0,0.011937,"There were no significant changes in any of the 8 generic subscales of HR-QoL neither in the exercise training group nor controls following an 8- week study. ","[{'ForeName': 'Boshra', 'Initials': 'B', 'LastName': 'Jamshidpour', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Bahrpeyma', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Electronic address: bahrpeyf@modares.ac.ir.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Khatami', 'Affiliation': 'Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.10.003'] 1985,32507285,[Comparison of two supraglottic airway devices on postoperative sore throat in children: a prospective randomized controlled trial].,"BACKGROUND AND OBJECTIVE Sore throat is well recognized complaint after receiving general anesthesia. This study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery - following the use of Ambu laryngeal mask airway) or I-gel® - who are able to self-report postoperative sore throat. METHOD Seventy children, 6 to 16 years-old, undergoing elective surgery randomly allocated to either Ambu laryngeal mask (Ambu Group) or I-gel® (I-gel Group). After the procedure, patients were interviewed in the recovery room immediately, after one hour, 6 and 24 hours postoperatively by an independent observer blinded to the device used intra-operatively. RESULTS On arrival in the recovery room 17.1% (n=6) of children of the Ambu Group complained of postoperative sore throat, against 5.7% in I-gel Group (n=2). After one hour, the results were similar. After 6 hours, postoperative sore throat was found in 8.6% (n=3) of the children in Ambu group vs. 2.9% (n=1) in I-gel Group. After 24hours, 2.9% (n=1) of the kids in Ambu Group compared to none in I-gel Group. There was no significant difference found in the incidence of postoperative sore throat in both devices on arrival (p=0.28); after 1 hour (p=0.28); after 6 hours (p=0.30); and after 24 hours (p=0.31). The duration of the insertion was shorter in Ambu Group and it was easier to insert the I-gel® (p=0.029). Oropharyngeal seal pressure of I-gel® was higher than that of Ambu laryngeal mask (p=0.001). CONCLUSION The severity and frequency of postoperative sore throat in children is not statistically significant in the I-gel Group compared to Ambu Group.",2020,The duration of the insertion was shorter in Ambu Group,"['children undergoing elective surgery - following the use of Ambu laryngeal mask airway) or I-gel® - who are able to self-report postoperative sore throat', 'Seventy children, 6 to 16 years-old, undergoing elective surgery randomly allocated to either', 'children']","['Ambu laryngeal mask (Ambu Group) or I-gel® (I-gel Group', 'supraglottic airway devices']","['severity and frequency of postoperative sore throat', 'incidence of postoperative sore throat', 'duration of the insertion', 'Oropharyngeal seal pressure of I-gel®', 'postoperative sore throat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",70.0,0.0754609,The duration of the insertion was shorter in Ambu Group,"[{'ForeName': 'Malika', 'Initials': 'M', 'LastName': 'Hameed', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan. Electronic address: malika.hameed@gmail.com.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Samad', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan.'}, {'ForeName': 'Hameed', 'Initials': 'H', 'LastName': 'Ullah', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.006'] 1986,32507332,Efficacy of Exercise Therapy Initiated in the Early Phase After Kidney Transplantation: A Pilot Study.,"OBJECTIVE In patients with kidney transplant (KT), frailty is a predictor of adverse outcomes. Outcomes of exercise therapy in patients with KT, particularly the efficacy of early exercise after KT, have not been evaluated. We investigated the effect of exercise intervention beginning early after KT on physical performance, physical activity, quality of life, and kidney function in patients with KT. METHODS KT recipients who underwent surgery with usual care plus exercise training from a prospective cohort (exercise group; n = 10) and those with usual care alone from a historical cohort (control group; n = 14) were included in this study. Early exercise comprised supervised aerobic training and physical activity instruction from day 6 to 2 months after KT. The following outcomes were measured: 6-minute walking distance, isometric knee extensor strength, gait speed, physical activity, quality of life, and estimated glomerular filtration rate. RESULTS Analyses of covariance, adjusted for baseline values, revealed significant mean differences between exercise and control groups at 2 months after KT in 6-minute walking distance (+44.4 m, P = .03) and isometric knee extensor strength (+8.1%body weight, P = .03). No significant between-group differences were found in gait speed, physical activity, and quality of life. The analysis of variance for comparison of the area under the recovery curves of estimated glomerular filtration rate after KT revealed no significant difference between groups. CONCLUSION Supervised aerobic training and physical activity instruction initiated in the early phase after KT can improve physical performance without adversely affecting kidney function.",2020,Supervised aerobic training and physical activity instruction initiated in the early phase after KT can improve physical performance without adversely affecting kidney function.,"['After Kidney Transplantation', 'patients with KT.\nMETHODS\n\n\nKT recipients who underwent surgery with', 'patients with kidney transplant (KT', 'patients with KT']","['usual care plus exercise training', 'Supervised aerobic training and physical activity instruction', 'exercise therapy', 'exercise intervention', 'Early exercise comprised supervised aerobic training and physical activity instruction', 'Exercise Therapy', 'exercise group; n\xa0=\xa010) and those with usual care alone from a historical cohort (control group; n\xa0=\xa014']","['6-minute walking distance', 'isometric knee extensor strength', 'physical performance, physical activity, quality of life, and kidney function', 'gait speed, physical activity, and quality of life', '6-minute walking distance, isometric knee extensor strength, gait speed, physical activity, quality of life, and estimated glomerular filtration rate', 'physical performance', 'glomerular filtration rate']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",14.0,0.0460617,Supervised aerobic training and physical activity instruction initiated in the early phase after KT can improve physical performance without adversely affecting kidney function.,"[{'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rehabilitation Sciences, Kitasato University Graduate School of medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Matsuzawa', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation, Hyogo University of Health Sciences, Kobe, Hyogo, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Kamitani', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Keika', 'Initials': 'K', 'LastName': 'Hoshi', 'Affiliation': 'Center for Public Health Informatics, National Institute of Public Health, Wako, Japan; Department of Hygiene, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ishii', 'Affiliation': 'Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Fumino', 'Initials': 'F', 'LastName': 'Noguchi', 'Affiliation': 'Department of Transplant Support Center, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Hamazaki', 'Affiliation': 'Department of Rehabilitation, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nozaki', 'Affiliation': 'Department of Rehabilitation, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Rehabilitation, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Maekawa', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Atsuhiko', 'Initials': 'A', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Rehabilitation Sciences, Kitasato University Graduate School of medical Sciences, Sagamihara, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Organ Transplant Medicine, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: kyoshida@med.kitasato-u.ac.jp.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.11.005'] 1987,32507357,A randomized open label efficacy clinical trial of oral guava leaf decoction in patients with acute infectious diarrhoea.,"BACKGROUND Diarrhoea is amongst the first ten causes of death and its treatment faces an increased threat of drug resistance. Previous studies on the guava leaf decoction (GLD) revealed its suitability for use in infectious diarrhoea of unknown etiology. OBJECTIVE The objective of this trial was to establish efficacy, dose and safety of GLD prepared from the Indian Sardar variety in adults with acute infectious diarrhoea. METHODS The current trial was an open efficacy randomized 5-day, parallel group multi-arm interventional study. Amongst 137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males). Three doses of GLD (6-leaf, 10-leaf and 14-leaf) were compared with controls receiving oral rehydration solution. Decrease in stool frequency and improvement in consistency were the outcomes measured. The data was analyzed using ANOVA, Tukey's post-hoc test, Kruscal-Wallis test and Chi-Square test where applicable. RESULTS The trial showed that the 14-leaf (7.4 g) decoction was the most effective. Administration of the decoction, thrice daily helped the patients regain normalcy in 72 h as opposed to 120 h in controls. Safety of the intervention was reflected by normal levels of haemoglobin, liver and kidney parameters. No adverse events were reported. CONCLUSION The 14 leaves decoction was a safe treatment for adult acute uncomplicated diarrhoea of unknown etiology. Moreover due to component synergy and divergent mechanisms of action, it could possibly combat the generation of drug resistance and destruction of gut microbiota. Hence GLD has the potential for development as a first line treatment for diarrhoea. TRIAL REGISTRATION Trial was registered with Clinical Trials Registry - India (CTRI registration number: CTRI/2016/07/007095). The trial was retrospectively registered.",2020,"No adverse events were reported. ","['137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males', 'adults with acute infectious diarrhoea', 'patients with acute infectious diarrhoea']","['GLD', 'guava leaf decoction (GLD', 'decoction', 'oral guava leaf decoction']","['adverse events', 'normal levels of haemoglobin, liver and kidney parameters', 'stool frequency']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453279', 'cui_str': 'Guava'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",137.0,0.145841,"No adverse events were reported. ","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Birdi', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India. Electronic address: fmr@fmrindia.org.'}, {'ForeName': 'G Geetha', 'Initials': 'GG', 'LastName': 'Krishnan', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Kataria', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Gholkar', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Daswani', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.04.001'] 1988,32507424,Mindfulness training for healthcare professional students: A waitlist controlled pilot study on psychological and work-relevant outcomes.,"OBJECTIVES To fill gaps in the literature on the effects of mindfulness for healthcare professionals (HCPs), the current pragmatic trial investigated feasibility, acceptability, and effectiveness of Mindfulness for Interdisciplinary Healthcare Professional (MIHP) students on stress and work-relevant outcomes in the absence of offering school-based incentives. DESIGN A partially randomized waitlist-controlled design (intention-to-treat sample: 22 in the mindfulness group, 26 in the control group) was employed. INTERVENTION MIHP is an eight-week intervention that incorporates meditation training, yoga, and discussion on the application of mindfulness principles to stressors commonly faced by HCPs and students. MAIN OUTCOME MEASURES Domains of feasibility and acceptability; Maslach Burnout Inventory and other validated measures of psychological functioning; cognitive task performance on the Trail Making Test A & B; and the Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire. RESULTS Results supported the feasibility and acceptability of MIHP but found randomization to be unacceptable. Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment. No effect of MIHP was found on cognitive performance or work productivity outcomes. CONCLUSIONS Preferential group allocation improved retention relative to randomization in the absence of school-based incentives. Results suggest that MIHP is feasible and acceptable and may have benefit for improving mindfulness and reducing burnout, stress, and activity impairment. Cognitive performance, work absenteeism, and work impairment did not change following MIHP. Results support future investigations into the effects of participant compensation on MIHP's dissemination and effectiveness.",2020,"Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment.",['healthcare professional students'],"['MIHP', 'Mindfulness training']","['Cognitive performance, work absenteeism, and work impairment', 'cognitive performance or work productivity outcomes', 'Domains of feasibility and acceptability; Maslach Burnout Inventory and other validated measures of psychological functioning; cognitive task performance on the Trail Making Test A & B; and the Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire', 'feasibility and acceptability of MIHP', 'outcomes of burnout, perceived stress, mindfulness, and activity impairment']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0305863,"Small to large effects were found for MIHP, relative to the control group, on outcomes of burnout, perceived stress, mindfulness, and activity impairment.","[{'ForeName': 'Sarah Ellen', 'Initials': 'SE', 'LastName': 'Braun', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States; Charleston Consortium Psychology Internship Program, United States. Electronic address: braunse2@vcu.edu.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Dow', 'Affiliation': 'Virginia Commonwealth University, Department of Internal Medicine, United States.'}, {'ForeName': 'Ashlee', 'Initials': 'A', 'LastName': 'Loughan', 'Affiliation': 'Virginia Commonwealth University, Department of Neurology, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Mladen', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'MaryKate', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rybarczyk', 'Affiliation': 'Virginia Commonwealth University, Department of Psychology, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kinser', 'Affiliation': 'Virginia Commonwealth University, School of Nursing, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102405'] 1989,32507426,Efficacy of Sweet Violet (Viola odorata) flower oil on the symptoms of adults with allergic rhinitis: A double-blind randomized placebo-controlled clinical trial.,,2020,,['adults with allergic rhinitis'],"['Sweet Violet (Viola odorata) flower oil', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.602706,,"[{'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Yazdi', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kardooni', 'Affiliation': 'Department of otolaryngology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Namjuyan', 'Affiliation': 'Ph.D of Pharmacognosy.'}, {'ForeName': 'Hossein Molavi', 'Initials': 'HM', 'LastName': 'Vardanjani', 'Affiliation': 'MPH Department, Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Tafazoli', 'Affiliation': 'Department of Traditional Medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Jaladat', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: drjaladat@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102408'] 1990,32507430,Effects of ear and body acupressure on labor pain and duration of labor active phase: A randomized controlled trial.,"OBJECTIVES This study sought to compare the effects of multi-point ear and body acupressure on labor pain and the duration of labor active phase. DESIGN Three-armed randomized controlled trial. SETTING Kowsar Hospital, Qazvin, Iran. INTERVENTION Participants in the body acupressure group received acupressure on GB21, GB30, BL32, LI4, and SP6 points, each for two minutes, at cervical dilation of four, six, and eight centimeters. For participants in the ear acupressure group, adhesive auriculotherapy-specific Vaccaria seeds were attached to their auricles on the zero, genitalia, Shen Men, thalamic, and uterine 1 and 2 acupoints. The seeds were compressed every thirty minutes, each time for thirty seconds. Participants in the control group received routine care services. MAIN OUTCOME MEASURES Labor pain intensity was assessed using a visual analogue scale at cervical dilation of four and ten centimeters. RESULTS While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001). However, the difference between the acupressure groups was not statistically significant (P = 0.12). Moreover, the duration of labor active phase in the ear acupressure group was significantly less than those in the body acupressure and the control groups (P < 0.001). CONCLUSION Ear acupressure was significantly effective in reducing labor pain and shortening labor active phase. However, body acupressure solely reduces labor pain. Therefore, ear acupressure can be used to reduce labor pain and shorten labor active phase.",2020,"While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001).","['Kowsar Hospital, Qazvin, Iran']","['routine care services', 'Ear acupressure', 'ear and body acupressure', 'multi-point ear and body acupressure', 'Participants in the body acupressure group received acupressure']","['duration of labor active phase', 'labor pain and shortening labor active phase', 'labor pain and duration of labor active phase', 'mean score of labor pain', 'mean scores of pain', 'labor pain', 'labor pain and the duration of labor active phase', 'Labor pain intensity', 'visual analogue scale at cervical dilation of four and ten centimeters']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0475210', 'cui_str': 'cm'}]",,0.0415952,"While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001).","[{'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Zainabalimoradi@yahoo.com.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: Faridehkazemi21@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gorji', 'Affiliation': 'Velayat Clinical & Educational Center, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: maryam.gorji580@gmail.com.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Valiani', 'Affiliation': 'Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: valiani@nm.mui.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102413'] 1991,32507432,"The beneficial effects of therapeutic craniofacial massage on quality of life, mental health and menopausal symptoms and body image: A randomized controlled clinical trial.","OBJECTIVE The objective of this study was to determine the effect of massage in the craniofacial area in menopausal women after the treatment and one month after its completion, and to measure its influence on quality of life in relation to symptoms of menopause, mental health, and body image perception. DESIGN 50 participants with menopause, aged 45-65 years, participated in a single-blind randomized controlled trial. Participants were randomly assigned to two groups: craniofacial massage group (CMG), who received massage treatment (n = 25), and control group (CG), without treatment (n = 25). Prior to randomization, all participants provided demographic and clinical information. Quality of life, mental health and body image perception were evaluated at three time points: at the beginning of the study, at the end, and one month after finishing the treatment. RESULTS A repeated-measures multivariate analysis of variance (RM-MANOVA) was used to determine if mean scores in the criteria differed significantly between time points within subjects. The results obtained indicate that the cranial massage techniques had a large, positive between-subjects effect on our three criteria (Wilks Λ = .83, F( 3, 44 ) = 3.04, p. <.05; Partial η = .17; ƒ = .45) as well as a large, positive between-within subjects effect (Wilks Λ = .64, F( 6, 41 ) = 3.91, p. <.01; Partial η = .36; ƒ = .76). In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores. CONCLUSIONS The craniofacial massage protocol, applied to the craniofacial sphere, constitutes a complementary and valid therapy-based therapeutic option for clinicians in the treatment of different symptoms that occur in the climacteric period.",2020,"In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores. ","['menopausal women', '50 participants with menopause, aged 45-65 years']","['therapeutic craniofacial massage', 'craniofacial massage group (CMG), who received massage treatment']","[""participants' mental health"", 'quality of life, mental health and menopausal symptoms and body image', ""Body Image perception's scores"", 'Menopause Rating Scale', 'Quality of life, mental health and body image perception', 'quality of life in relation to symptoms of menopause, mental health, and body image perception']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",50.0,0.0713743,"In short, our treatment improved participants' mental health, partially ameliorated the decrease in scores on the Menopause Rating Scale and stopped the decrease in Body Image perception's scores. ","[{'ForeName': 'Gemma V', 'Initials': 'GV', 'LastName': 'Espí-López', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: gemma.espi@uv.es.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Monzani', 'Affiliation': 'Ivey Business School at Western University, Canada. Electronic address: lmonzani@ivey.ca.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gabaldón-García', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: elenagabaldongarcia@gmail.com.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Zurriaga', 'Affiliation': 'University Research Institute of Human Resources Psychology, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Spain. Electronic address: Rosario.Zurriaga@uv.es.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102415'] 1992,32507434,The effects of acupressure on the symptoms severity and function status and electrodiagnostic findings in patients with carpal tunnel syndrome.,"OBJECTIVE This study aimed to evaluate the effects of acupressure on the symptoms severity, function status and electrodiagnostic findings in patients with Carpal tunnel syndrome (CTS). DESIGN This double blind, randomized, controlled clinical trial study was conducted on 57 patients with CTS that selected through convenience sampling. The patients were randomly assigned to three groups, including (1) acupressure; (2) placebo acupressure; and (3) control. SETTING The study was conducted in the medical centers affiliated to Semnan University of Medical Sciences, Iran. INTERVENTION The intervention groups received acupressure or placebo for one month. The control group received only routine cares (splints and analgesics) with no additional intervention. PRIMARY OUTCOMES The severity of symptoms and hand function were evaluated by the Boston Carpal Tunnel Syndrome Questionnaire, and electrodiagnostic findings, including Nerve Conduction Velocity (NCV), Distal Sensory Latency (DSL), and Distal Motor Latency (DML) were measured by Electromyography device before and after the intervention. RESULTS The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05). Significant differences were also observed between the means difference in severity of symptoms, hand function, and NCV, DSL, and DML before and after the intervention in the three groups (P < 0.05). CONCLUSION According to the results, acupressure was effective in reducing the severity of clinical symptoms, improving the hand function, and improving the electrodiagnostic findings. Therefore, the application of acupressure can be recommended for improving clinical symptoms of patients with CTS.",2020,"The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05).","['medical centers affiliated to Semnan University of Medical Sciences, Iran', '57 patients with CTS that selected through convenience sampling', 'patients with CTS', 'patients with Carpal tunnel syndrome (CTS', 'patients with carpal tunnel syndrome']","['routine cares (splints and analgesics) with no additional intervention', 'acupressure or placebo', 'acupressure; (2) placebo acupressure; and (3) control', 'acupressure']","['severity of clinical symptoms, improving the hand function, and improving the electrodiagnostic findings', 'mean severity of symptoms, hand function, NCV, DSL, and DML', 'Boston Carpal Tunnel Syndrome Questionnaire, and electrodiagnostic findings, including Nerve Conduction Velocity (NCV), Distal Sensory Latency (DSL), and Distal Motor Latency (DML', 'severity of symptoms, hand function, and NCV, DSL, and DML', 'severity of symptoms and hand function']","[{'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0429381', 'cui_str': 'Nerve conduction velocity'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",57.0,0.0170938,"The results showed significant differences in the mean severity of symptoms, hand function, NCV, DSL, and DML before and after the intervention in the acupressure group (P < 0.05).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Asgari', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Saeideh Sadat', 'Initials': 'SS', 'LastName': 'Mosaviinejad', 'Affiliation': 'Student Research Committee, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Ebrahimian', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Aminianfar', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Physiotherapy, School of Rehabilitation Sciences, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Epidemiology and Biostatistics, Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Babamohamadi', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Nursing, Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: babamohamadi@semums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102420'] 1993,32507479,High early phase hemoglobin level is associated with favorable neurological outcome in patients with severe traumatic brain injury.,"BACKGROUND The appropriate hemoglobin (Hb) level threshold for the early phase (i.e. from Emergency Department to ICU admission) in patients with severe traumatic brain injury (TBI) is still unknown. Therefore, we aimed to examine the association between Hb levels during the early phase and neurological outcomes in patients with severe TBI using data from the Brain Hypothermia (B-HYPO) Study Group. METHODS We performed a post-hoc analysis of the B-HYPO study (a prospective, multicenter, randomized controlled trial on patients with severe TBI who received either mild therapeutic hypothermia [MTH; 32.0 °C-34.0 °C] or fever control [35.5 °C-37.0 °C]). We calculated Hb levels during early phase by the formula: (admission Hb + Hb on day 1) / 2. The primary outcome was the association between during early phase Hb levels and 6-month neurological outcome after the TBI based on the Glasgow Outcome Scale scores (a measure of functional recovery defined as moderate disability or good recovery). RESULTS We reviewed data from 130 patients and found favorable neurological outcomes in 48.5% of them. We found significant differences between the favorable and unfavorable neurological outcome groups in terms of their Hb levels on admission and on day 1. But, we found no Hb level differences after day 3 (including 1 day after rewarming). Our multivariable analysis showed that Hb levels during early phase were significantly associated with favorable neurological outcomes (odds ratio, 1.387; 95% confidence interval, 1.057-1.858; P = 0.018). CONCLUSIONS High early phase Hb levels are associated with favorable neurological outcomes after severe TBI.",2020,"Our multivariable analysis showed that Hb levels during early phase were significantly associated with favorable neurological outcomes (odds ratio, 1.387; 95% confidence interval, 1.057-1.858; P = 0.018). ","['patients with severe traumatic brain injury', 'patients with severe TBI who received either mild therapeutic hypothermia [MTH; 32.0\xa0°C-34.0\xa0°C] or fever control ', 'patients with severe TBI using data from the Brain Hypothermia (B-HYPO', '35.5\xa0°C-37.0', 'patients with severe traumatic brain injury (TBI']",[],"['favorable neurological outcomes', 'association between during early phase Hb levels and 6-month neurological outcome after the TBI based on the Glasgow Outcome Scale scores (a measure of functional recovery defined as moderate disability or good recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0026234', 'cui_str': 'Plicamycin'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]",[],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",130.0,0.0633272,"Our multivariable analysis showed that Hb levels during early phase were significantly associated with favorable neurological outcomes (odds ratio, 1.387; 95% confidence interval, 1.057-1.858; P = 0.018). ","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hifumi', 'Affiliation': ""Emergency and Critical Care Medicine, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan; Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan. Electronic address: hifumitoru@gmail.com.""}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kuroda', 'Affiliation': 'Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Kawakita', 'Affiliation': 'Department of Emergency, Disaster and Critical Care Medicine, Kagawa University Hospital, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University School of Medicine, 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Emergency Medicine, Tokuyama Central Hospital, 1-1 Kouda, Shunan, Yamaguchi 745-8522, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Emergency, Disaster and Critical Care Medicine, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kobata', 'Affiliation': 'Osaka Mishima Emergency Critical Care Center, 11-1 Minamiakutagawacho, Takatsuki, Osaka 569-1124, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Suehiro', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University School of Medicine, 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Maekawa', 'Affiliation': 'Yamaguchi Prefectural University, 3-2-1 Sakurabatake, Yamaguchi City, Yamaguchi 753-8502, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.04.065'] 1994,32507490,Comparison of Preadministered and Coadministered Lidocaine for Treating Pain and Distress Associated With Intranasal Midazolam Administration in Children: A Randomized Clinical Trial.,"STUDY OBJECTIVE The pain and distress associated with intranasal midazolam administration can be decreased by administering lidocaine before intranasal midazolam (preadministered lidocaine) or combining the lidocaine with midazolam in a single solution (coadministered lidocaine). We hypothesize that coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration. METHODS We conducted a randomized, outcome assessor-blinded, noninferiority trial. Children aged 6 months to 7 years undergoing laceration repair received intranasal midazolam with preadministered or coadministered lidocaine. Pain and distress was evaluated with the Observational Scale of Behavioral Distress-Revised (OSBD-R) (primary outcome; noninferiority margin +1.8 units) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS); Faces, Legs, Activity, Cry, Consolability (FLACC) scale; and cry duration (secondary outcomes). Secondary outcomes also included adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration. RESULTS Fifty-one patients were analyzed, with a median age of 2 years. Difference in OSBD-R scores was -0.6 units (95% confidence interval -2.8 to 1.7 units), favoring preadministered lidocaine. CHEOPS and FLACC scores and cry duration were similar between groups. OSBD-R, CHEOPS, FLACC scores, and cry duration associated with the administration of intranasal lidocaine alone were 3.8, 9.9, and 6 units, and 56 seconds, respectively. Clinicians preferred coadministered lidocaine and considered it easier to administer. CONCLUSION Coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration and was preferred by clinicians. Administration of intranasal lidocaine was associated with a measurable degree of pain and distress.",2020,Coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration and was preferred by clinicians.,"['Fifty-one patients were analyzed, with a median age of 2 years', 'Children', 'Children aged 6 months to 7 years undergoing laceration repair received']","['midazolam (preadministered lidocaine', 'Midazolam', 'intranasal lidocaine', 'lidocaine', 'Coadministered lidocaine', 'Preadministered and Coadministered Lidocaine', 'preadministered lidocaine', 'midazolam', 'lidocaine with midazolam', 'intranasal midazolam with preadministered or coadministered lidocaine']","[""Children's Hospital of Eastern Ontario Pain Scale (CHEOPS); Faces, Legs, Activity, Cry, Consolability (FLACC) scale; and cry duration (secondary outcomes"", 'OSBD-R, CHEOPS, FLACC scores, and cry duration', 'OSBD-R scores', 'pain and distress', 'Observational Scale of Behavioral Distress-Revised (OSBD-R', 'CHEOPS and FLACC scores and cry duration', 'adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration', 'Pain and distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3701948', 'cui_str': 'Laceration repair'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",51.0,0.201182,Coadministered lidocaine is noninferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration and was preferred by clinicians.,"[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; Department of Emergency Medicine, Westchester Medical Center, Valhalla, NY. Electronic address: noconnell07@gmail.com.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Woodward', 'Affiliation': ""Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; NewYork-Presbyterian Morgan Stanley Children's Hospital, New York, NY.""}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Flores-Sanchez', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Son H', 'Initials': 'SH', 'LastName': 'McLaren', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ieni', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'McKinley', 'Affiliation': ""Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY; Division of Emergency Medicine, Children's National Hospital, Washington, DC.""}, {'ForeName': 'Sripriya T', 'Initials': 'ST', 'LastName': 'Shen', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Dayan', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Tsze', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.04.025'] 1995,32507535,The effect of inhalation aromatherapy with damask rose essence on pain intensity and anxiety in burned patients: A single-blind randomized clinical trial.,"INTRODUCTION Pain and anxiety are a major problem of burn patients. Despite the use of different medications, patients still suffer from these two problems. Aromatherapy along with medication may help in alleviating these symptoms. This study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on pain and anxiety in burn patients. METHODS This three group clinical trial was conducted on 120 patients with burns less than 30% TBSA. The patients were randomly allocated into three groups, aromatherapy damask rose essence, placebo, and control. The pain intensity was assessed using visual analogue scale prior to intervention, immediately before, and 15 min after dressing. Anxiety was measured using Spielberger Inventory at before intervention and 15 min after dressing, also the prolonged effect of intervention on pain was assessed by number of the analgesics drugs received for four hours after dressing change. The intervention included inhalation of 6 drops of 40% damask rose essential oil in the damask group, and six drops of distilled water in placebo group one hour before dressing change. The control group received no intervention. RESULTS Baseline state-trait anxiety and pain intensity were similar in these three groups (p > 0.05). We found a significant reduction in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups (p < 0.001). However, we found no significant difference between the placebo and control groups in terms of these variables at these times (p > 0.05). Also, we found no significant difference among three groups in frequency of analgesics drugs and trait anxiety after intervention (p > 0.05). CONCLUSION Inhaled aromatherapy with Damask rose essence reduces subjective pain intensity and state anxiety in burned patients. Therefore, it is recommended considering use of damask rose essence, as an easy and affordable method along with other treatments.",2020,We found a significant reduction in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups (p < 0.001).,"['burned patients', 'burn patients', '120 patients with burns less than 30% TBSA']","['Aromatherapy', 'no intervention', 'aromatherapy damask rose essence, placebo, and control', 'inhalation of 6 drops of 40% damask rose essential oil in the damask group, and six drops of distilled water in placebo', 'inhalation aromatherapy with damask rose essence', 'Inhaled aromatherapy with Damask rose essence', 'placebo']","['pain intensity and anxiety', 'pain and anxiety', 'pain intensity', 'frequency of analgesics drugs and trait anxiety', 'Anxiety', 'subjective pain intensity and state anxiety', 'pain', 'Baseline state-trait anxiety and pain intensity', 'state anxiety']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1290922', 'cui_str': 'Baseline state'}]",120.0,0.0466098,We found a significant reduction in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups (p < 0.001).,"[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Sadeghi', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Azizi', 'Affiliation': 'Chronic Diseases (Home Care) Research Center, Malayer Nursing School, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: Azimazizi1360@gmail.com.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Malayer Nursing School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.05.006'] 1996,32507538,Vitamin D Supplementation Improves Health-Related Quality of Life and Physical Performance in Children with Sickle Cell Disease and in Healthy Children.,"INTRODUCTION No study determined if vitamin D supplementation improves health-related quality of life (HRQL) using pediatric Patient-Reported Outcomes Measurement Information System or physical functioning in type SS sickle cell disease (HbSS). METHOD Subjects with HbSS (n = 21) and healthy subjects (n = 23) were randomized to daily oral doses (4,000 vs. 7,000 IU) of cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning. RESULTS In subjects with HbSS, significant reductions in pain, fatigue, and depressive symptoms and improved upper-extremity function were observed. In healthy subjects, significant reductions in fatigue and improved upper-extremity function were observed. Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups. In subjects with HbSS, improved plantar flexion isometric maximal voluntary contraction torques were observed. Both groups saw significant improvement in their total Bruininks-Oseretsky Test of Motor Proficiency score. DISCUSSION Daily high-dose vitamin D supplementation for African American children with and without HbSS improved HRQL and physical performance.",2020,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"['African American children', 'type SS sickle cell disease (HbSS', 'Subjects with HbSS (n\u202f=\u202f21) and healthy subjects (n\u202f=\u202f23', 'Children with Sickle Cell Disease and in Healthy Children']","['Vitamin D Supplementation', 'cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning', 'vitamin D supplementation']","['Health-Related Quality of Life and Physical Performance', 'health-related quality of life (HRQL', 'pain, fatigue, and depressive symptoms and improved upper-extremity function', 'HRQL and physical performance', 'total Bruininks-Oseretsky Test of Motor Proficiency score', 'peak power and dorsiflexion isometric maximal voluntary contraction torques', 'fatigue and improved upper-extremity function', 'plantar flexion isometric maximal voluntary contraction torques']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}]",23.0,0.0773497,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Dougherty', 'Affiliation': ''}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bertolaso', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': ''}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.007'] 1997,32507551,Prevalence of NAFLD in Guatemala following exposure to a protein-energy nutrition intervention in early life.,"INTRODUCTION AND OBJECTIVES The global prevalence of non-alcoholic fatty liver disease (NAFLD) is approximately 25%, with Hispanic populations at greatest risk. We describe the prevalence of NAFLD in a cohort of Guatemalan adults and examine whether exposure to a protein-energy supplement from conception to two years is associated with lower prevalence of NAFLD. MATERIALS AND METHODS From 1969 to 1977, four villages in Guatemala were cluster-randomized to receive a protein-energy supplement (Atole) or a no-protein, low-energy beverage (Fresco). We conducted a follow-up of participants from 2015 to 2017. We assessed blood samples (n=1093; 61.1% women; aged 37-53 years) for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and estimated NAFLD prevalence using the liver fat score. We used generalized linear and logistic models to estimate the difference-in-difference effect of Atole from conception to two years on NAFLD. RESULTS Median ALT and AST were 19.7U/L (interquartile range, IQR: 14.1, 27.4) and 26.0U/L (IQR: 21.4, 32.8), respectively. The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001). The prevalence of NAFLD was 67.4% among women and 39.5% among men (p<0.0001). The association between Atole exposure from conception to two years and NAFLD was not significant (OR: 0.90, 95% CI: 0.50-1.63). CONCLUSIONS NAFLD prevalence among Guatemalan adults exceeds the global average. Protein-energy supplementation in early life was not associated with later NAFLD. There is a need for further studies on the causes and onset of NAFLD throughout the life course.",2020,"The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001).","['participants from 2015 to 2017', 'From 1969 to 1977, four villages in Guatemala', 'n=1093; 61.1% women; aged 37-53 years) for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and estimated NAFLD prevalence using the liver fat score']","['Protein-energy supplementation', 'protein-energy nutrition intervention', 'protein-energy supplement (Atole) or a no-protein, low-energy beverage (Fresco']","['blood samples', 'prevalence of NAFLD', 'median NAFLD liver fat score']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0556077', 'cui_str': 'Energy supplementation'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0835527,"The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001).","[{'ForeName': 'Ahlia', 'Initials': 'A', 'LastName': 'Sekkarie', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA. Electronic address: asekkar@emory.edu.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Welsh', 'Affiliation': 'Department of Pediatrics, Emory School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': 'Department of Pediatrics, Emory School of Medicine, Atlanta, GA, USA.'}]",Annals of hepatology,['10.1016/j.aohep.2020.04.004'] 1998,32493468,"Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill. TRIAL DESIGN This is a single center, open label, randomized, controlled, parallel group, clinical trial that will be conducted at Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences. PARTICIPANTS Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9 th to April 14 th 2020. Patients will be randomly assigned to the intervention groups or the control group with the following eligibility criteria: ≥ 18 years of age AND (oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24) AND at least one of the following: Contactless infrared forehead thermometer temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission, and time of onset of the symptoms should be acute (Days ≤ 14). Although Hydroxychloroquine will be administered in a single dose, patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes) will be excluded. Other exclusion criteria include using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β 1b, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results and refusal to participate. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services. INTERVENTION AND COMPARATOR COVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra). MAIN OUTCOMES Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. Secondary outcomes include mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. If any patient dies, we have reached an important secondary outcome. SpO2 Improvement between the last and first day of hospitalization, using pulse-oximetry. Duration of hospitalization from date of randomization until the date of hospital discharge or date of death from any cause, whichever comes first. Incidence of new mechanical ventilation uses from date of randomization until the last day of the study. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Statistical analysis will be performed by R version 3.6.1 software. We will use Kaplan-Meier to analyze the time to clinical improvement (compared with a log-rank test). Hazard ratios with 95% confidence intervals will be calculated using the Cox proportional-hazards model in crude and adjusted analysis. RANDOMIZATION Eligible patients will be randomly assigned in a 1:1:1 ratio to receive either Interferon Beta 1a, Interferon Beta 1b or standard care only. Patients will be randomly allocated to three therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases. BLINDING (MASKING) The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) Of the 60 patients who underwent randomization, 20 patients were assigned to receive Interferon beta-1a, 20 patients were assigned to receive Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone. TRIAL STATUS Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on 9 th April 2020 and the end date was on 14 th April 2020. Last point of data collection will be the last day on which all of the 60 participants have had an outcome of clinical improvement or death, completing the study's follow-up time window. TRIAL REGISTRATION This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1.","['adults with moderate to severe COVID-19', '20 patients', 'patients that have tested positive and are moderately to severely ill', 'Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences', 'registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020', 'Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services', 'Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9 th to April 14 th 2020', '60 patients who underwent randomization', 'patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes']","['Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen', 'Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon', 'Interferon Beta 1a, Interferon Beta 1b or standard care only', 'Hydroxychloroquine', 'Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β', 'Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra', 'Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone', 'Interferon Beta 1a, compared to Interferon Beta', 'Interferon']","['Hazard ratios', 'SpO2 Improvement', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040479', 'cui_str': 'Torsades de pointes'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",20.0,0.114249,"The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1.","[{'ForeName': 'Seyed Sina Naghibi', 'Initials': 'SSN', 'LastName': 'Irvani', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Golmohammadi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ilad Alavi', 'Initials': 'IA', 'LastName': 'Darazam', 'Affiliation': 'Department of Infectious Diseases, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ilad.alavi@sbmu.ac.ir.'}]",Trials,['10.1186/s13063-020-04382-3'] 1999,32500016,Prediction of Gestational Diabetes by Measuring the Levels of Pregnancy Associated Plasma Protein-A (PAPP-A) During Gestation Weeks 11-14.,"Background The present study aimed to determine the association between pregnancy-associated plasma protein A (PAPP-A) and Gestational Diabetes Methods (GDM) to detect a risk factor for predicting GDM at gestational weeks 11-14. Methods This analytical prospective study recruited 284 pregnant women presenting to six healthcare centers of Qazvin, Iran from February to December 2016. PAPP-A was measured at gestational weeks 11-14 and glucose tolerance test was conducted at gestational weeks 24-28. The participants were assigned into two groups of exposure (reduced PAPP-A) and non-exposure (normal PAPP-A). The association between GDM and PAPP-A was studied. The number of women in exposure group were 201 and 83 in the non-exposure group. Differences between groups were assessed by the Mann-Whitney, Chi-square, T test, logistic regression analysis and ROC Curve with a significance level of 0.05. Results Twenty eight (33.73%) patients of the exposure group and 17 (8.46%) of non-exposure group developed GDM. There was a significant difference between the two groups in terms of GDM (p<0.001) and the risk of GDM was 3.98 fold higher in the exposure group (reduced PAPPA mu/L ) than that of the non-exposure group (CI=2.39-6.65, p<0.001). Also, 53.3% of the exposure group and 46.7% of the nonexposure group were diagnosed with GDM (p=0.02). There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020). According to the ROC curve results, PAPP-A and MOM are acceptable indicators for predicting GDM. Conclusion A low PAPP-A level (MOM, MU/L) as a new risk factor for GDM can help early prediction and prevent maternal and fetal complication by timely treatment.",2020,"There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020).","['284 pregnant women presenting to six healthcare centers of Qazvin, Iran from February to December 2016']","['PAPP', 'exposure (reduced PAPP-A) and non-exposure (normal PAPP-A']","['GDM', 'risk of GDM', 'PAPPA MOM', 'Levels of Pregnancy Associated Plasma Protein-A (PAPP-A']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0135262', 'cui_str': '1-(2-(4-aminophenyl)ethyl)-4-(3-trifluoromethylphenyl)piperazine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0232989', 'cui_str': 'Normal pregnancy'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",284.0,0.0325339,"There was a significant difference in GDM between the groups and the risk of GDM was 1.85 times higher in the exposure group (reduced PAPPA MOM) than that in the control group (CI=1.09-3.15, p=0.020).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ramezani', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboubeh Ahmadi', 'Initials': 'MA', 'LastName': 'Doulabi', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Saqhafi', 'Affiliation': 'School of Paramedical Sciences, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Alipoor', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Journal of reproduction & infertility,[] 2000,32501595,Metformin monotherapy for adults with type 2 diabetes mellitus.,"BACKGROUND Worldwide, there is an increasing incidence of type 2 diabetes mellitus (T2DM). Metformin is still the recommended first-line glucose-lowering drug for people with T2DM. Despite this, the effects of metformin on patient-important outcomes are still not clarified. OBJECTIVES To assess the effects of metformin monotherapy in adults with T2DM. SEARCH METHODS We based our search on a systematic report from the Agency for Healthcare Research and Quality, and topped-up the search in CENTRAL, MEDLINE, Embase, WHO ICTRP, and ClinicalTrials.gov. Additionally, we searched the reference lists of included trials and systematic reviews, as well as health technology assessment reports and medical agencies. The date of the last search for all databases was 2 December 2019, except Embase (searched up 28 April 2017). SELECTION CRITERIA We included randomised controlled trials (RCTs) with at least one year's duration comparing metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs in adults with T2DM. DATA COLLECTION AND ANALYSIS Two review authors read all abstracts and full-text articles/records, assessed risk of bias, and extracted outcome data independently. We resolved discrepancies by involvement of a third review author. For meta-analyses we used a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall certainty of the evidence by using the GRADE instrument. MAIN RESULTS We included 18 RCTs with multiple study arms (N = 10,680). The percentage of participants finishing the trials was approximately 58% in all groups. Treatment duration ranged from one to 10.7 years. We judged no trials to be at low risk of bias on all 'Risk of bias' domains. The main outcomes of interest were all-cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD). Two trials compared metformin (N = 370) with insulin (N = 454). Neither trial reported on all-cause mortality, SAE, CVM, NFMI, NFS or ESRD. One trial provided information on HRQoL but did not show a substantial difference between the interventions. Seven trials compared metformin with sulphonylureas. Four trials reported on all-cause mortality: in three trials no participant died, and in the remaining trial 31/1454 participants (2.1%) in the metformin group died compared with 31/1441 participants (2.2%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on SAE: in two trials no SAE occurred (186 participants); in the other trial 331/1454 participants (22.8%) in the metformin group experienced a SAE compared with 308/1441 participants (21.4%) in the sulphonylurea group (very low-certainty evidence). Two trials reported on CVM: in one trial no CVM was observed and in the other trial 4/1441 participants (0.3%) in the metformin group died of cardiovascular reasons compared with 8/1447 participants (0.6%) in the sulphonylurea group (very low-certainty evidence). Three trials reported on NFMI: in two trials no NFMI occurred, and in the other trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 15/1441 participants (1.0%) in the sulphonylurea group (very low-certainty evidence). One trial reported no NFS occurred (very low-certainty evidence). No trial reported on HRQoL or ESRD. Seven trials compared metformin with thiazolidinediones (very low-certainty evidence for all outcomes). Five trials reported on all-cause mortality: in two trials no participant died; the overall RR was 0.88, 95% CI 0.55 to 1.39; P = 0.57; 5 trials; 4402 participants). Four trials reported on SAE, the RR was 0,95, 95% CI 0.84 to 1.09; P = 0.49; 3208 participants. Four trials reported on CVM, the RR was 0.71, 95% CI 0.21 to 2.39; P = 0.58; 3211 participants. Three trial reported on NFMI: in two trials no NFMI occurred and in one trial 21/1454 participants (1.4%) in the metformin group experienced a NFMI compared with 25/1456 participants (1.7%) in the thiazolidinedione group. One trial reported no NFS occurred. No trial reported on HRQoL or ESRD. Three trials compared metformin with dipeptidyl peptidase-4 inhibitors (one trial each with saxagliptin, sitagliptin, vildagliptin with altogether 1977 participants). There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes). One trial compared metformin with a glucagon-like peptide-1 analogue (very low-certainty evidence for all reported outcomes). There was no substantial difference between the interventions for all-cause mortality, CVM, NFMI and NFS. One or more SAEs were reported in 16/268 (6.0%) of the participants allocated to metformin compared with 35/539 (6.5%) of the participants allocated to a glucagon-like peptide-1 analogue. HRQoL or ESRD were not reported. One trial compared metformin with meglitinide and two trials compared metformin with no intervention. No deaths or SAEs occurred (very low-certainty evidence) no other patient-important outcomes were reported. No trial compared metformin with placebo or a behaviour changing interventions. Four ongoing trials with 5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024. Furthermore, 24 trials with 2369 participants are awaiting assessment. AUTHORS' CONCLUSIONS There is no clear evidence whether metformin monotherapy compared with no intervention, behaviour changing interventions or other glucose-lowering drugs influences patient-important outcomes.",2020,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","['adults with type 2 diabetes mellitus', 'N = 370) with insulin (N = 454', '18 RCTs with multiple study arms (N = 10,680', 'people with T2DM', 'with altogether 1977 participants', '2369 participants are awaiting assessment', '5824 participants are likely to report one or more of our outcomes of interest and are estimated to be completed between 2018 and 2024', 'adults with T2DM']","['metformin monotherapy', 'Metformin', 'SAE', 'metformin with placebo', 'sulphonylurea', 'Metformin monotherapy', 'saxagliptin, sitagliptin, vildagliptin', 'glucagon-like peptide-1 analogue', 'metformin', 'CVM', 'thiazolidinedione', 'NFMI', 'metformin with dipeptidyl peptidase-4 inhibitors', 'metformin monotherapy with no intervention, behaviour changing interventions or other glucose-lowering drugs', 'metformin with thiazolidinediones']","['cause mortality, SAE, CVM, NFMI and NFS', 'HRQoL or ESRD', 'cause mortality, SAE, CVM, NFMI, NFS or ESRD', 'deaths or SAEs', 'died of cardiovascular reasons', 'CVM', 'NFMI', 'cause mortality, serious adverse events (SAEs), health-related quality of life (HRQoL), cardiovascular mortality (CVM), non-fatal myocardial infarction (NFMI), non-fatal stroke (NFS), and end-stage renal disease (ESRD', 'cause mortality', 'overall RR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007872', 'cui_str': 'Cervical mucus'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",370.0,0.173295,"There was no substantial difference between the interventions for all-cause mortality, SAE, CVM, NFMI and NFS (very low-certainty evidence for all outcomes).","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Gnesin', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Department 7652, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anne Cathrine Baun', 'Initials': 'ACB', 'LastName': 'Thuesen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lise Katrine Aronsen', 'Initials': 'LKA', 'LastName': 'Kähler', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012906.pub2'] 2001,32501761,"Open-label, randomised, multicentre crossover trial assessing two-layer compression bandaging for chronic venous insufficiency: results of the APRICOT trial.","Compression bandaging is the mainstay therapy for chronic venous insufficiency and venous leg ulcers, but patient compliance can be challenging due to associated discomfort. The study discussed here aimed to compare AndoFlex TLC Calamine and Coban2 compression bandaging in relation to patient comfort and pruritus symptomology, with severity of pruritus as the primary outcome. This was a multi-centre, prospective, non-blinded, randomised controlled crossover trial involving 39 randomised patients with chronic venous insufficiency patients. In two periods, the patients wore AndoFlex TLC Calamine or Coban2 for 3 weeks each. No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test). However, after trying both bandages, 21 of the 35 patients (60%) definitely preferred AndoFlex TLC Calamine, whereas 4 patients (11%) definitely preferred Coban2. Thus, AndoFlex TLC Calamine compression bandage therapy was preferred by most patients, although this observation could not be confirmed using validated patient-reported outcome measures for pruritus. Further research is indicated to establish if patient preference translates into favourable clinical outcomes. ISRCTN number: ISRCTN95282887.",2020,"No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test).","['chronic venous insufficiency', '39 randomised patients with chronic venous insufficiency patients']","['AndoFlex TLC Calamine and Coban2 compression bandaging', 'Compression bandaging', 'layer compression bandaging', 'AndoFlex TLC Calamine compression bandage therapy']",['severity of pruritus scale'],"[{'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0357929', 'cui_str': 'Calamine'}, {'cui': 'C1533146', 'cui_str': 'Compression bandaging'}, {'cui': 'C0677875', 'cui_str': 'Compression Bandage'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",39.0,0.098107,"No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test).","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Jonker', 'Affiliation': 'Science and Innovation Manager, North Cumbria Integrated Care NHS Foundation Trust, Carlisle.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Todhunter', 'Affiliation': 'Specialist Vascular Nurse, North Cumbria Integrated Care NHS Trust.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Specialist Vascular Nurse, North Cumbria Integrated Care NHS Trust.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Research GP, North Cumbria Integrated Care NHS Trust.'}]",British journal of community nursing,['10.12968/bjcn.2020.25.Sup6.S6'] 2002,32502772,The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.,"OBJECTIVE To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS). DESIGN Single centre double blind randomised controlled trial. PARTICIPANTS Women aged 18 years or over who had a CS. INTERVENTIONS All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group). MAIN OUTCOME MEASURES The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate. RESULTS 324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups. CONCLUSIONS This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.",2020,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","['Women aged 18 years or over who had a CS', '324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group', 'surgical site infection following caesarean section']","['caesarean section (CS', 'copper impregnated wound dressings', 'copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group']","['SSI rates', 'infection rate', 'length of hospital stay, and readmission rate', 'incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire', 'surgical site infection (SSI) rate', 'Length of hospital stay, and readmission rate', 'incidence of superficial/deep SSI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",324.0,0.239103,"The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002).","[{'ForeName': 'Linda P', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Research Fellow, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: l.p.arendsen@gmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Consultant Obstetrician and Urogynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, United Kingdom. Electronic address: ranee.thakar@nhs.net.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, Amersham, United Kingdom. Electronic address: paul@statsconsultancy.co.uk.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Consultant Obstetrician and UroGynaecologist, Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, Croydon, CR7 7YE, United Kingdom Honorary Reader, St George's University of London. Electronic address: abdulsultan@nhs.net.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.016'] 2003,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA). DESIGN Randomized equivalence trial. SETTING University Hospital. PATIENTS Sixty patients undergoing primary THA. INTERVENTIONS Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h. MEASUREMENTS A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale. MAIN RESULTS No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048). CONCLUSIONS For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907'] 2004,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities. RESEARCH QUESTION Is underwater gait training or overground gait training more effective in severe stroke patients? METHODS A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training. RESULTS Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm). SIGNIFICANCE In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking. CLINICAL TRIAL REGISTRATION NUMBER KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022'] 2005,32503494,Effects of trimetazidine on ventricular remodeling in coronary artery disease patients with left ventricular hypertrophy: the rationale and design of a randomized controlled trial.,"BACKGROUND Trimetazidine is a metabolic anti-ischemic agent, which increases the tolerance of cardiomyocytes to ischemia. However, few studies have explored the effect of trimetazidine on ventricular remodeling in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH). METHODS It is a randomized, placebo-controlled trial, and we propose to recruit one hundred and twenty-four CAD patients undergoing PCI with LVH during a 12-month period. They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI. Blood tests, echocardiography, symptom of angina and major adverse cardiovascular events (MACEs) will be collected at follow-up visit at 3 and 12 months. The primary end point will be the left ventricular remodeling measured by left ventricular mass index (LVMI) at 3- and 12-month follow-up compared with the baseline. The secondary end points will be the symptom of angina assessed by Seattle Angina Questionnaire, myocardial ischemia measured by 6-min walk test and exercise electrocardiography test, as well as MACEs (defined as a composite of death, myocardial infarction, stroke, recurrent angina, re-hospitalization, change of viable myocardium). DISCUSSION This study aims to demonstrate the effect of trimetazidine on left ventricular remodeling and myocardial ischemia in CAD patients undergoing PCI with LVH. Trimetazidine treatment is likely to improve the left ventricular remodeling, symptoms of angina and myocardial ischemia. It might also reduce the risk of MACEs in CAD patients undergoing PCI with LVH. TRIAL REGISTRATION http://www.chictr.org.cn, Chinese Clinical Trial Registry (ChiCTR1800017876). Registered on 19 Aug 2018.",2020,They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI.,"['coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with left ventricular hypertrophy (LVH', 'coronary artery disease patients with left ventricular hypertrophy', 'recruit one hundred and twenty-four CAD patients undergoing PCI with LVH during a 12-month period', 'CAD patients undergoing PCI with LVH']","['Trimetazidine', 'trimetazidine', 'placebo']","['left ventricular remodeling, symptoms of angina and myocardial ischemia', 'left ventricular remodeling measured by left ventricular mass index (LVMI', 'Blood tests, echocardiography, symptom of angina and major adverse cardiovascular events (MACEs', 'left ventricular remodeling and myocardial ischemia', 'ventricular remodeling', 'symptom of angina assessed by Seattle Angina Questionnaire, myocardial ischemia measured by 6-min walk test and exercise electrocardiography test, as well as MACEs (defined as a composite of death, myocardial infarction, stroke, recurrent angina, re-hospitalization, change of viable myocardium', 'risk of MACEs']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.187267,They will be randomized to receive either trimetazidine (35 mg twice a day) or placebo in the following 12 months after PCI.,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luan', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Chongying', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 310016, P.R. China. 3313011@zju.edu.cn.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01557-3'] 2006,32503502,"Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial.","BACKGROUND Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. METHODS A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. RESULTS The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. CONCLUSIONS Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. TRIAL REGISTRATION This trial was registered at www.clinicaltrials.gov under the name ""Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent"" with date 2nd November 2017, code NCT03343275, and URL.",2020,Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91,['105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain'],['placebo'],"['Mean encrustation score', 'urine pH decrease, stent removal, and incidence of adverse events', 'global encrustation rate of stent ends', 'efficacy and safety', 'urine pH decreases', 'degree of stent ends encrustation, defined by a 4-point score (0 - none; 3 - global encrustation) using macroscopic and electron microscopy analysis of crystals', 'incidence of adverse events']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0854059', 'cui_str': 'pH urine decreased'}, {'cui': 'C0522778', 'cui_str': 'Removal of stent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",105.0,0.781105,Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Torrecilla', 'Affiliation': 'Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Fernández-Concha', 'Affiliation': 'Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Cansino', 'Affiliation': 'La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Mainez', 'Affiliation': 'La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'José H', 'Initials': 'JH', 'LastName': 'Amón', 'Affiliation': 'Rio Hortega University Hospital, Valladolid, Spain.'}, {'ForeName': 'Simbad', 'Initials': 'S', 'LastName': 'Costas', 'Affiliation': 'Mateu Orfila Hospital, Maó, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Angerri', 'Affiliation': 'Puigvert Foundation, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Emiliani', 'Affiliation': 'Puigvert Foundation, Barcelona, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Arrabal Martín', 'Affiliation': 'San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Arrabal Polo', 'Affiliation': 'San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Virgen de Valme University Hospital, Sevilla, Spain.'}, {'ForeName': 'Manuel C', 'Initials': 'MC', 'LastName': 'Reina', 'Affiliation': 'Virgen de Valme University Hospital, Sevilla, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Sánchez', 'Affiliation': 'Álvaro Cunqueiro Hospital, Vigo, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Budía', 'Affiliation': 'University and Polytechnic La Fe Hospital, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pérez-Fentes', 'Affiliation': 'University Hospital Complex of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Grases', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain. fgrases@uib.es.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Costa-Bauzá', 'Affiliation': 'Laboratory of Renal Lithiasis Research, University Institute of Health Sciences Research (IUNICS- IDISBA), University of Balearic Islands (UIB), Palma de Mallorca, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuñé', 'Affiliation': 'Devicare S.L., Cerdanyola del Vallès, Spain.'}]",BMC urology,['10.1186/s12894-020-00633-2'] 2007,32503515,"Comparison of ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide in treatment for patients with community-acquired pneumonia without risk factors for aspiration: an open-label, quasi-randomized, controlled trial.","BACKGROUND Ceftriaxone (CTRX) and ampicillin/sulbactam (ABPC/SBT) are recommended by various guidelines as the first-line antibiotics for community-acquired pneumonia (CAP). However, which of these antibiotics is more effective for treating non-aspiration CAP remains unclear. METHODS This study was a prospective, single-center, open-label, quasi-randomized controlled trial. Patients with adult CAP without risk for aspiration were allocated to either a CTRX or ABPC/SBT group based on the date of hospital admission. Macrolide was added to patients in each group. The primary outcome was the clinical response in the validated per-protocol (VPP) population at end of treatment (EOT). The secondary outcomes were clinical response during treatment and at end of study (EOS) in the VPP population, and mortality rate at day 30 in the modified intention-to-treat (MITT) population. RESULTS Of 696 screened patients, 433 patients were excluded and 263 patients were allocated to receive either of the treatments. Males comprised 54% of patients and mean age and PSI were 62.1 ± 19.8 years and 69.3 ± 30.0, respectively, with 124 patients allocated to the CTRX group and 138 patients allocated to the ABPC/SBT group. The clinical effectiveness rate for the VPP population at EOT was 90% in the CTRX and 96% in the ABPC/SBT group (p = 0.072, 95% confidence interval [CI] of risk difference [RD]: - 12.6-0.8%). No significant difference in effectiveness at day 4 was observed between the CTRX and ABPC/SBT groups (p = 0.079, 95%CI of RD: - 12.1-0.4%), but at day 7, ABPC/SBT was significantly more effective than CTRX in the VPP population (p = 0.047, 95%CI of RD: - 13.3--0.4%). No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053). Deaths within 30 days in MITT population was higher in CTRX group (4 [3%]) than in ABPC/SBT group (0 [0%]) (p = 0.048, 95%CI of RD: 0.1-6.3%). CONCLUSION No significant difference in effectiveness was found between ABPC/SBT and CTRX at EOT. However, ABPC/SBT might be more effective in the early phase of treatment. TRIAL REGISTRATION UMIN-CTR, UMIN000037464. Registered 25 July 2019 - Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042262.",2020,"No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053).","['696 screened patients, 433 patients were excluded and 263 patients', 'Males comprised 54% of patients and mean age and PSI were 62.1\u2009±\u200919.8\u2009years and 69.3\u2009±\u200930.0, respectively, with 124 patients allocated to the CTRX group and 138 patients allocated to the', 'patients with community-acquired pneumonia without risk factors for aspiration', 'Patients with adult CAP without risk for aspiration']","['CTRX or ABPC/SBT', 'Ceftriaxone (CTRX) and ampicillin/sulbactam (ABPC/SBT', 'Macrolide', 'ABPC/SBT', 'CTRX', 'ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide']","['clinical response during treatment and at end of study (EOS) in the VPP population, and mortality rate', 'failure', 'late response at EOS', 'clinical effectiveness rate', 'clinical response in the validated per-protocol (VPP) population at end of treatment (EOT', 'Deaths', 'relapse']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150012', 'cui_str': 'At risk for aspiration'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0036782', 'cui_str': 'Serum bactericidal titer test'}, {'cui': 'C2930041', 'cui_str': 'sultamicillin'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",433.0,0.115557,"No significant difference in late response at EOS was seen between CTRX and ABPC/SBT groups: cure (89 [86%] and 102 [94%]), relapse (5 [5%] and 1 [1%]) and failure (10 [10%] and 5 [5%]; p = 0.053).","[{'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Hamao', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan. isaoito@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Konishi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shirata', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Oi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Tsukino', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Yasutomo', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Seizo', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo, 675-1332, Japan.'}, {'ForeName': 'Toyohiro', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaracho, Sakyo, Kyoto, 606-8507, Japan.'}]",BMC pulmonary medicine,['10.1186/s12890-020-01198-4'] 2008,32503517,Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial.,"BACKGROUND About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a ""stretch and tone"" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health. METHODS Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable. RESULTS Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control). CONCLUSIONS This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial. TRIAL REGISTRATION ClinicalTrials.gov. NCT02925481. Registered 10-04-16.",2020,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","['women after stillbirth', 'women who have experienced stillbirth', 'Participants (N\xa0=\u200990', 'stillbirth mothers']","['online yoga intervention', 'stretch and tone"" control', 'Online yoga', 'yoga or exercise (low dose (LD), 60\u2009min per week; moderate dose (MD), 150\u2009min per week; and stretch-and-tone control group (STC']","['depression scores', 'symptoms of post traumatic stress disorder (PTSD), depression, and anxiety', 'symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health', 'grief intensity', 'PTSD and depression, and improvements in self-rated health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.104793,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Tempe, USA. Jhuberty@asu.edu.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kurka', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Leiferman', 'Affiliation': 'Colorado School of Public Health, Denver, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gold', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cacciatore', 'Affiliation': 'Arizona State University, Tempe, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02926-3'] 2009,32503545,Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis.,,2020,,['homeless people in Denmark'],[],[],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]",[],[],,0.129307,,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Bring', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark. camillabring@hotmail.com.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Mikkel Z', 'Initials': 'MZ', 'LastName': 'Ankarfeldt', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Brünés', 'Affiliation': 'Patient Care, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Amager and Hvidovre, Kettegaard Alle 30, 2650, Hvidovre, Denmark.'}]",BMC health services research,['10.1186/s12913-020-05358-4'] 2010,32504284,"N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer.","BACKGROUND The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC). METHODS In this single-arm, 2-stage, phase II study, patients with stages I-III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety. RESULTS Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. CONCLUSION TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.",2020,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. ","['early-stage HER2-positive breast cancer (HER2+\u2009BC', 'Thirty eligible patients were enrolled', 'early-stage HER2-positive breast cancer']","['standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen', 'TCH plus L', 'lapatinib (L) to trastuzumab (T', 'docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy', 'N083E', 'TCHL']","['safety and tolerability', 'rate of diarrhea', 'Cardiovascular AE', 'congestive heart failure', 'Diarrhea', 'adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",30.0,0.0277203,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. ","[{'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Leon-Ferre', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Celyne', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of General Oncology, MD Anderson Cancer Center Bay Area, Nassau Bay, TX, USA.'}, {'ForeName': 'Alejandra T', 'Initials': 'AT', 'LastName': 'Perez', 'Affiliation': 'Breast Cancer Centers, Memorial Cancer Institute, Hollywood, FL, USA.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Hematology/Oncology, Wichita Community Clinical Oncology Program, Wichita, KS, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Carolla', 'Affiliation': 'Department of Hematology/Oncology, Cancer Research for the Ozarks, Springfield, MO, USA.'}, {'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Zon', 'Affiliation': 'Department of Oncology, North Indiana Cancer Research Consortium CCOP, South Bend, IN, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. morenoaspitia.alvaro@mayo.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05709-z'] 2011,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type. METHODS 579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group. RESULTS 124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. CONCLUSION We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154'] 2012,32509467,A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women.,"Background Stress reactivity can be different in women compared to men, which might consequently influence disease risk.Stress in women may also generate adverse physiological effects on their offspring during pregnancy or lactation. The objective of this study was to compare the effects of different relaxation interventions on physiological outcomes and perceived relaxation in healthy young women, to assist in identifying the most appropriate intervention(s) for use in a subsequent trial for mothers who deliver prematurely. Methods A within-subject study was conducted in 17 women of reproductive age comparing five different relaxation interventions (guided-imagery meditation audio (GIM), music listening (ML), relaxation lighting (RL), GIM+RL, ML+RL), with control (silence/sitting), assigned in random order over a 3-6 week period. Subjective feelings of relaxation (10-point scale), heart rate (HR), systolic and diastolic blood pressure (SBP, DBP), and fingertip temperature (FT) were measured before and after each technique. Results All interventions significantly increased perceived relaxation and FT, while music also significantly reduced SBP ( p  < 0.05). Compared to control, HR significantly decreased following GIM (mean difference = 3.2 bpm, p  < 0.05), and FT increased (mean difference = 2.2 °C, p  < 0.05) and SBP decreased (mean difference = 3.3 mmHg, p  < 0.01) following ML. GIM + RL followed by GIM were the most preferred interventions. Conclusions Based on preference, simplicity, and the physiological and psychological effects, GIM and ML were identified as the most effective tools for reducing stress and improving relaxation. These techniques warrant further research in larger samples and other populations.",2020,"Results All interventions significantly increased perceived relaxation and FT, while music also significantly reduced SBP ( p  < 0.05).","['mothers who deliver prematurely', '17 women of reproductive age comparing five different', 'young women', 'healthy young women']","['relaxation interventions (guided-imagery meditation audio (GIM), music listening (ML), relaxation lighting (RL), GIM+RL, ML+RL), with control (silence/sitting', 'relaxation interventions', 'GIM + RL', 'relaxation therapies']","['perceived relaxation and FT, while music also significantly reduced SBP', 'FT', 'SBP', 'Subjective feelings of relaxation (10-point scale), heart rate (HR), systolic and diastolic blood pressure (SBP, DBP), and fingertip temperature (FT']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0522165', 'cui_str': 'Feeling calm'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",17.0,0.0327117,"Results All interventions significantly increased perceived relaxation and FT, while music also significantly reduced SBP ( p  < 0.05).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dib', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Jonathan C K', 'Initials': 'JCK', 'LastName': 'Wells', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}]",PeerJ,['10.7717/peerj.9217'] 2013,32509626,"Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars.","Introduction Stainless steel crowns are the most successful restoration for multisurface carious lesions in primary molars. The esthetics has been poorly accepted which led to the introduction of zirconia crowns. Objectives The aim of the study was to evaluate and compare the clinical success, parental satisfaction, and child satisfaction of stainless steel and zirconia crowns in primary molars. Methods Thirty healthy patients aged 6-8 years bilateral pulp therapy treated primary molars were randomly divided into two equal groups of stainless steel and zirconia crowns. Tooth preparation was done according to the manufacturers' recommendations depending upon the crown each patient would receive. All crowns were cemented with Type I GIC luting cement. Patients were evaluated at 6 months, 12 months, 18 months, 24 months, and 36 months. Results Clinical success for stainless steel crowns and zirconia crowns were similar with no statistical difference between them. Zirconia accumulated less plaque than stainless steel crowns ( P = 0.047). The parental satisfaction was high with both crowns. A highly significant statistical difference existed between the 2 groups in relation to the acceptance of color ( P < 0.001) and child's satisfaction ( P < 0.001). Conclusion Zirconia can be considered as an esthetic alternative in the future.",2020,Zirconia accumulated less plaque than stainless steel crowns ( P = 0.047).,"['All crowns were cemented with Type', 'Stainless Steel Crowns and Zirconia Crowns in Primary Molars', 'Thirty healthy patients aged 6-8 years bilateral pulp therapy treated primary molars']",['stainless steel and zirconia crowns'],"['Clinical Success, Parental and Child Satisfaction', ""child's satisfaction"", 'acceptance of color', 'clinical success, parental satisfaction, and child satisfaction', 'parental satisfaction']","[{'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",30.0,0.035567,Zirconia accumulated less plaque than stainless steel crowns ( P = 0.047).,"[{'ForeName': 'Mebin George', 'Initials': 'MG', 'LastName': 'Mathew', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Korishettar Basavaraj', 'Initials': 'KB', 'LastName': 'Roopa', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, College of Dental Sciences, Davangere, Karnataka, India.'}, {'ForeName': 'Ashu Jagdish', 'Initials': 'AJ', 'LastName': 'Soni', 'Affiliation': ""Department of Pediatric Dentistry, Dr. Ashu's Dental Clinic, Vadodara, India.""}, {'ForeName': 'Md Muzammil', 'Initials': 'MM', 'LastName': 'Khan', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Bapuji Dental College and Hospital, Davangere, India.'}, {'ForeName': 'Afreen', 'Initials': 'A', 'LastName': 'Kauser', 'Affiliation': 'Department of Orthodontics, College of Dental Sciences, Davangere, Karnataka, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1006_19'] 2014,32509658,Role of natural salivary defenses in the maintenance of healthy oral microbiota in children and adolescents.,"Aim The present study served the purpose of assessing the levels of salivary immunoglobulin A (IgA), immunoglobulin G (IgG), proteins, calcium, inorganic phosphorus, and alkaline phosphatase levels in caries-free and caries active children. Materials and Methods Stratified randomized sampling method was used to include 40 subjects in the age group 12-15 years having a full complement of permanent dentition except for third molars. The selected pediatric subjects were further divided into two groups of 20 each based on DMFS score, Group-I - Caries free (DMFS score = 0) and Group-II - Caries active (DMFS score ≥10). Unstimulated midmorning saliva samples were collected and analyzed colorimetrically and by radial immunodiffusion method for constituents of saliva understudy. Results The mean salivary IgA levels in children in Group-I (caries-free children) was 10.63 ± 2.85 mg/dL which was statistically higher as compared to caries active children in Group-II (8.50 ± 1.43 mg/dL).The mean salivary protein level in children of Group-II was statistically higher at 3.28 ± 0.12 mg/dL as compared to Group-I (2.89 ± 0.11 mg/dL). Conclusion The present study showed decreased levels of salivary immunoglobulin A and high concentration of salivary protein in children with increased caries experience which is indicative of the protective role of salivary constituents in caries-free children.",2020,The present study showed decreased levels of salivary immunoglobulin A and high concentration of salivary protein in children with increased caries experience which is indicative of the protective role of salivary constituents in caries-free children.,"['children with increased caries experience', 'selected pediatric subjects', 'caries-free and caries active children', '40 subjects in the age group 12-15 years having a full complement of permanent dentition except for third molars', 'healthy oral microbiota in children and adolescents']",[],"['salivary protein level', 'salivary immunoglobulin A (IgA), immunoglobulin G (IgG), proteins, calcium, inorganic phosphorus, and alkaline phosphatase levels', 'mean salivary IgA levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0429170', 'cui_str': 'Caries active'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0036100', 'cui_str': 'Salivary Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0371998,The present study showed decreased levels of salivary immunoglobulin A and high concentration of salivary protein in children with increased caries experience which is indicative of the protective role of salivary constituents in caries-free children.,"[{'ForeName': 'Mohammed Ahsan', 'Initials': 'MA', 'LastName': 'Razi', 'Affiliation': 'Department of Periodontology, Hazaribag College of Dental Sciences and Hospital, Hazaribag, Jharkhand, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Qamar', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Hazaribag College of Dental Sciences and Hospital, Hazaribag, Jharkhand, India.'}, {'ForeName': 'Adya', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Department of Periodontology, Hazaribag College of Dental Sciences and Hospital, Hazaribag, Jharkhand, India.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Periodontology, Goverment Dental College Shimla, Snowdown, Himachal Pradesh, India.'}, {'ForeName': 'Shandar', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Hazaribag College of Dental Sciences and Hospital, Hazaribag, Jharkhand, India.'}, {'ForeName': 'Ruchi Staffy', 'Initials': 'RS', 'LastName': 'Mohina Minz', 'Affiliation': 'Department of Periodontology, Hazaribag College of Dental Sciences and Hospital, Hazaribag, Jharkhand, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1134_19'] 2015,32509676,Investigating the impact of silymarin on liver oxidative injury.,"Introduction Various drugs affect liver problems caused by general hypoxia, including silymarin. Due to the fungal killer toxins, nowadays, silymarin (milk thistle) is used as an effective drug in the prevention and treatment of liver diseases and liver toxicity. In addition, silymarin protects the liver cells from solvents and chemical substances. The aim of this paper is to investigate the impact of silymarin on liver problems induced by general hypoxia. Material and Methods This study was a double-blinded clinical trial on patients with hypoxia who referred to the hospital emergency department. Patients were randomly divided into case and control groups. The case group was treated with silymarin at a dose of 280 mg with orally gavage technique and the control group was treated with a placebo every 8 h for 3 days. To investigate the leukocytosis, liver enzymes levels of alanine transaminase (ALT), aspartate aminotransferase (AST), creatine phosphokinase (CPK), prothrombin time (PT), partial thromboplastin (PTT), international normalized ratio (INR), and white blood cell (WBC) were measured before and after the intervention. SPSS 21 software was used to analyze the data. Results In the silymarin group, liver enzymes were lower than the placebo group on the third day after treatment ( P < 0.05). There was no significant difference between the two groups in terms of coagulation factors and WBC count on the third day after treatment ( P > 050). On the third day after treatment, the amount of GGT was lower in the silymarin group ( P < 0.05). Conclusion Silymarin decreased liver enzymes (ALT, AST, and CPK) and the level of GGT. Therefore, it is recommended to be used in patients with hypoxic liver injury.",2020,There was no significant difference between the two groups in terms of coagulation factors and WBC count on the third day after treatment ( P > 050).,"['patients with hypoxic liver injury', 'patients with hypoxia who referred to the hospital emergency department']","['silymarin', 'placebo']","['leukocytosis, liver enzymes levels of alanine transaminase (ALT), aspartate aminotransferase (AST), creatine phosphokinase (CPK), prothrombin time (PT), partial thromboplastin (PTT), international normalized ratio (INR), and white blood cell (WBC', 'coagulation factors and WBC count', 'amount of GGT', 'liver enzymes', 'liver enzymes (ALT, AST, and CPK) and the level of GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0288837,There was no significant difference between the two groups in terms of coagulation factors and WBC count on the third day after treatment ( P > 050).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Jamalian', 'Affiliation': 'Department of Forensic Medicine and Poisoning, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Mahmodiyeh', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Saveiee', 'Affiliation': 'Department of Forensic Medicine and Poisoning, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Solhi', 'Affiliation': 'Department of Forensic Medicine and Poisoning, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_929_19'] 2016,32508129,Effects on shoulder pain and disability of teaching patients with shoulder pain a home-based exercise program: a randomized controlled trial.,"OBJECTIVE To investigate the effect on shoulder pain and disability of teaching patients with shoulder pain how to undertake a home-based exercise program. DESIGN A randomized controlled trial conducted from September 2015 to January 2016. SETTING Participants' home. PARTICIPANTS Sixty participants with shoulder pain who were waiting for physiotherapeutic treatment. INTERVENTIONS The control group ( n  = 30) received minimal education about their shoulder condition and instructions to continue their activities as normal. The intervention group ( n  = 30) received a two-month home exercise program with one-hour sessions delivered by a physiotherapist to begin and one month after the program for exercise instructions. MAIN MEASURES The primary outcome was change in the Shoulder Pain and Disability Index (SPADI). The secondary outcomes included change in the numeric pain rating scale and medication intake for pain relief. RESULTS The patients' average age was 54.3 (13.8) years. SPADI scores at baseline were 60.9 (16.5) in the intervention and 64.7 (15.3) in the control group. After two months, the SPADI scores decreased to 18.8 (28.6) and to 61.4 (24.0), respectively, in the intervention and control groups with an estimated mean difference of 40.0, effect size: 1.61. The intervention group showed a reduced pain intensity (estimated mean difference: 3.7, effect size: 2.43) and medication intake (chi-square: 0.001). The number needed to treat was 1.2 for one patient to have a SPADI score <20. CONCLUSION Teaching patients with shoulder pain how to undertake a home-based exercise program improved shoulder function and reduced pain intensity and medication intake over two months.",2020,"The intervention group showed a reduced pain intensity (estimated mean difference: 3.7, effect size: 2.43) and medication intake (chi-square: 0.001).","['teaching patients with shoulder pain a home-based exercise program', 'Teaching patients with shoulder pain', 'Sixty participants with shoulder pain who were waiting for physiotherapeutic treatment', ""Participants' home"", 'teaching patients with shoulder pain', 'September 2015 to January 2016', ""patients' average age was 54.3 (13.8)\u2009years""]",['minimal education about their shoulder condition and instructions to continue their activities as normal'],"['Shoulder Pain and Disability Index (SPADI', 'shoulder function and reduced pain intensity and medication intake', 'SPADI scores', 'shoulder pain and disability', 'reduced pain intensity', 'numeric pain rating scale and medication intake for pain relief', 'medication intake']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",60.0,0.106214,"The intervention group showed a reduced pain intensity (estimated mean difference: 3.7, effect size: 2.43) and medication intake (chi-square: 0.001).","[{'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Santello', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Denise Martineli', 'Initials': 'DM', 'LastName': 'Rossi', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Martins', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Thiele de Cássia', 'Initials': 'TC', 'LastName': 'Libardoni', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Anamaria Siriani', 'Initials': 'AS', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215520930790'] 2017,32508141,"Countering demand for ineffective health remedies: Do consumers respond to risks, lack of benefits, or both?","Objective: We tested whether targeting the illusion of causality and/or misperceptions about health risks had the potential to reduce consumer demand for an ineffective health remedy (multivitamin supplements). Design: We adopted a 2 (contingency information: no/yes) × 2 (fear appeal: no/yes) factorial design, with willingness-to-pay as the dependent variable. The contingency information specified, in table format, the number of people reporting a benefit vs. no benefit from both multivitamins and placebo, plus a causal explanation for lack of efficacy over placebo. The fear appeal involved a summary of clinical-trial results that indicated multivitamins can cause health harms. The control condition received only irrelevant information. Main outcome measure: Experimental auctions measured people's willingness-to-pay for multivitamins. Experiment 1 ( N  = 260) elicited hypothetical willingness-to-pay online. Experiment 2 ( N  = 207) elicited incentivised willingness-to-pay in the laboratory. Results: Compared to a control group, we found independent effects of contingency information (-22%) and the fear appeal (-32%) on willingness-to-pay. The combination of both interventions had the greatest impact (-50%) on willingness-to-pay. Conclusion: We found evidence that consumer choices are influenced by both perceptions of efficacy and risk. The combination of both elements can provide additive effects that appear superior to either approach alone.",2020,"Compared to a control group, we found independent effects of contingency information (-22%) and the fear appeal (-32%) on willingness-to-pay.",[],"['hypothetical willingness-to-pay online', 'placebo']","['fear appeal', "" Experimental auctions measured people's willingness-to-pay for multivitamins""]",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}]",,0.0506924,"Compared to a control group, we found independent effects of contingency information (-22%) and the fear appeal (-32%) on willingness-to-pay.","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'MacFarlane', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hurlstone', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Ullrich K H', 'Initials': 'UKH', 'LastName': 'Ecker', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, Australia.'}]",Psychology & health,['10.1080/08870446.2020.1774056'] 2018,32508183,"App-based supplemental exercise in rehabilitation, adherence, and effect on outcomes: a randomized controlled trial.","QUESTION To determine the uptake of an app-based supplemental exercise programme in a rehabilitation setting and the effect of such a programme on length of stay and function compared to usual care physiotherapy. DESIGN Randomized controlled trial with random allocation and assessor blinding. PARTICIPANTS A total of 144 individuals with mixed diagnoses (orthopaedic, neurological, reconditioning) admitted for inpatient sub-acute rehabilitation. INTERVENTIONS Participants were randomly allocated to usual care physiotherapy (control group) or usual care physiotherapy with the addition of an app-based supplemental exercise programme (intervention group). OUTCOME MEASURES The primary measure of interest was total supplementary exercise dosage completed by the intervention group. The primary between-group outcome measure was length of stay with secondary measures including walking endurance (Six-Minute Walk Test), walking speed (10-Metre Walk Test), functional mobility (Timed Up and Go Test) and level of disability (Functional Independence Measure). RESULTS Participants in the intervention group performed 7 minutes (SD: 9) or 49 repetitions (SD: 48) of supplementary exercise using the app each day. There were no differences between the groups for length of stay (mean difference (MD): -0.5 days, 95% confidence interval (CI): -3.2 to 2.2) or change in any secondary functional outcome measures, including walking speed (MD: -0.1 m/s, 95% CI: -0.2 to 0.0) and disability (MD: -0.9, 95% CI: -3.6 to 1.8). CONCLUSION A small supplementary exercise dose was achieved by participants in the intervention group. However, such a programme did not affect length of stay or functional outcomes when compared to usual care.",2020,"There were no differences between the groups for length of stay (mean difference (MD): -0.5 days, 95% confidence interval (CI): -3.2 to 2.2) or change in any secondary functional outcome measures, including walking speed (MD: -0.1 m/s, 95% CI: -0.2 to 0.0) and disability (MD: -0.9, 95% CI: -3.6 to 1.8). ","['A total of 144 individuals with mixed diagnoses (orthopaedic, neurological, reconditioning) admitted for inpatient sub-acute rehabilitation']","['usual care physiotherapy (control group) or usual care physiotherapy with the addition of an app-based supplemental exercise programme (intervention group', 'app-based supplemental exercise programme', 'App-based supplemental exercise']","['length of stay or functional outcomes', 'disability', 'length of stay', 'length of stay and function', 'walking speed', 'length of stay with secondary measures including walking endurance (Six-Minute Walk Test), walking speed (10-Metre Walk Test), functional mobility (Timed Up and Go Test) and level of disability (Functional Independence Measure']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}]",144.0,0.122362,"There were no differences between the groups for length of stay (mean difference (MD): -0.5 days, 95% confidence interval (CI): -3.2 to 2.2) or change in any secondary functional outcome measures, including walking speed (MD: -0.1 m/s, 95% CI: -0.2 to 0.0) and disability (MD: -0.9, 95% CI: -3.6 to 1.8). ","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Li', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Tram', 'Initials': 'T', 'LastName': 'Bui', 'Affiliation': 'Royal Rehab, Sydney, NSW, Australia.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Phan', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Llado', 'Affiliation': 'Royal Rehab, Sydney, NSW, Australia.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Royal Rehab, Sydney, NSW, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Scrivener', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, NSW, Australia.'}]",Clinical rehabilitation,['10.1177/0269215520928119'] 2019,32508191,The Contribution of Therapeutic Horseback Riding to the Improvement of Executive Functions and Self-Esteem Among Children With ADHD.,"Background: Attention deficit hyperactive disorder (ADHD) is associated with difficulties in executive functions (EFs), ( assessed by questionnaires ) and self-esteem. Objective: To examine the contribution of therapeutic horseback riding to the EFs' improvement and self-esteem. Method: In total, 123 Israeli children diagnosed with ADHD participated in the study. The study group participated in 20 weeks of therapeutic horseback riding sessions in addition to receiving medication, whereas the control group received only medication. The children and their mothers filled out questionnaires before treatment, at the end of treatment, and 12 weeks after the treatment ended. To examine changes in the children's EFs and self-esteem, a series of latent growth models (LGMs) were conducted. Results: Therapeutic horseback riding contributed to the improvement of EFs and self-esteem. Improved self-esteem predicted subsequent improvement in EFs. Conclusion: Therapeutic horseback riding is an effective therapeutic method to improve EFs and self-esteem among children with ADHD.",2020,Therapeutic horseback riding is an effective therapeutic method to improve EFs and self-esteem among children with ADHD.,"['Children With ADHD', '123 Israeli children diagnosed with ADHD participated in the study', 'children with ADHD']","['therapeutic horseback riding sessions', 'control group received only medication']","['Executive Functions and Self-Esteem', 'Improved self-esteem predicted subsequent improvement in EFs', 'EFs and self-esteem']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0336962', 'cui_str': 'Horseback riding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",123.0,0.0149459,Therapeutic horseback riding is an effective therapeutic method to improve EFs and self-esteem among children with ADHD.,"[{'ForeName': 'Tal-Li Matild', 'Initials': 'TM', 'LastName': 'Aviv', 'Affiliation': 'Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Yaacov J', 'Initials': 'YJ', 'LastName': 'Katz', 'Affiliation': 'Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Ety', 'Initials': 'E', 'LastName': 'Berant', 'Affiliation': 'Interdisciplinary Center Herzliya, Israel.'}]",Journal of attention disorders,['10.1177/1087054720925898'] 2020,32508201,Attentional bias to diabetes cues mediates disease management improvements in a pilot randomized controlled trial for adolescents with type 1 diabetes.,"For type 1 diabetes management, the role of attentional bias remains unclear. This secondary analysis examined type 1 diabetes attentional bias and adolescent type 1 diabetes management prior to and during a cognitive and behavioral intervention. Youth with type 1 diabetes and above target glycemic control were assigned to intervention or usual care control. Participants completed baseline and follow-up type 1 diabetes Stroop tasks, HbA1c tests, and blood glucose meter downloads. Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors. Type 1 diabetes attentional bias is a potential target to improve type 1 diabetes management.",2020,"Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors.","['Youth with type 1 diabetes and above target glycemic control', 'adolescents with type 1 diabetes']",['intervention or usual care control'],"['diabetes Stroop tasks, HbA1c tests, and blood glucose meter downloads', 'diabetes management behaviors', 'type 1 diabetes attentional bias']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",,0.0201172,"Intervention was associated with greater reductions in type 1 diabetes attentional bias than control, and these reductions partially mediated the effect of treatment on diabetes management behaviors.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Drexel University, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hughes Lansing', 'Affiliation': 'University of Nevada, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Carracher', 'Affiliation': 'Geisel School of Medicine at Dartmouth, USA.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Vaid', 'Affiliation': 'Pennsylvania State University, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanger', 'Affiliation': 'Geisel School of Medicine at Dartmouth, USA.'}]",Journal of health psychology,['10.1177/1359105320926535'] 2021,32508338,The effects of hemiplegic shoulder pain on upper extremity motor function and proprioception.,"BACKGROUND Hemiplegic shoulder pain (HSP) after stroke has negative effects on functional use of hemiplegic arm. OBJECTIVE This study aimed to investigate the effects of HSP on upper extremity motor function and proprioception. METHODS A hundred and twenty-two patients with hemiplegia were included in this study. The patients' shoulder pain was evaluated by Visual Analog Scale. According to pain scores, patients were divided into two groups as group with HSP (Group 1, n = 76) and group without HSP (Group 2, n = 46). Upper extremity motor function level and proprioception were assessed by using Fugl Meyer Motor Function Scale and the Laser-pointer Assisted Angle Reproduction Test for the 45°, 60° and 90° of shoulder flexion. RESULTS Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005). Correlation analysis revealed a significant positive correlation between HSP severity, and upper extremity motor dysfunction and proprioceptive impairment (p < 0.005). CONCLUSIONS Presence of HSP is one of the main determinators of upper extremity motor function level and proprioceptive ability at different angles. Management of HSP can make a significant contribution to sensorimotor integration by leading to recovery in the motor function and proprioceptive acuity.",2020,"RESULTS Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005).",['A hundred and twenty-two patients with hemiplegia'],"['HSP', 'hemiplegic shoulder pain']","[""Upper extremity motor function and shoulder's proprioceptive sense"", 'Visual Analog Scale', 'shoulder pain', 'HSP severity, and upper extremity motor dysfunction and proprioceptive impairment']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0395128,"RESULTS Upper extremity motor function and shoulder's proprioceptive sense at each angles of group 1 were found significantly worse than group 2's (p≤0.005).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Duray', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Süleyman Demirel University, Isparta, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Baskan', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}]",NeuroRehabilitation,['10.3233/NRE-203049'] 2022,32508339,Robot-assisted gait training promotes brain reorganization after stroke: A randomized controlled pilot study.,"BACKGROUND Robot-assisted gait training (RAGT) can improve walking ability after stroke but the underlying mechanisms are unknown. OBJECTIVE We evaluated the changes in the injured brain after RAGT and compared the effects of early start and late start of RAGT. METHODS Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset and were randomly assigned into two groups. Group 1 started RAGT with conventional physiotherapy immediately after enrollment, whereas Group 2 underwent conventional physiotherapy for 4 weeks before starting RAGT. We acquired diffusion tensor imaging data after enrollment and at 4 and 8 weeks after treatment. Fractional anisotropy (FA) and mean diffusivity (MD) maps were used to analyze the neural changes. RESULTS Repeated measures analysis of variance of the data at 4 weeks after treatment showed a significant interaction between time and groups (RAGT versus control) for the FA and MD values in the non-lesioned hemisphere, indicating that the non-lesioned hemisphere was significantly reorganized by RAGT compared with conventional physiotherapy. Analysis of the data at 8 weeks after treatment showed a significant interaction between time and groups (early and late start of RAGT) for the MD values in the motor-related areas bilaterally, indicating that early start of RAGT significantly accelerated bi-hemispheric reorganization as compared with late start of RAGT. CONCLUSIONS Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri. Furthermore, early start of RAGT can accelerate bi-hemispheric reorganization in the motor-related brain regions.",2020,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.",['Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset'],"['conventional physiotherapy', 'Robot-assisted gait training (RAGT', 'Robot-assisted gait training', 'RAGT']",['Fractional anisotropy (FA) and mean diffusivity (MD) maps'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",11.0,0.0447341,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.","[{'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Chang Soon', 'Initials': 'CS', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Kyeong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203054'] 2023,32508341,"Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial.","BACKGROUND Backward walking is recommended to improve the components of physiological gait in neurological disease. Botulinum toxin type A is an effective safe first line-treatment for post-stroke spasticity. OBJECTIVE To compare the effects of backward treadmill training (BTT) versus standard forward treadmill training (FTT) on motor impairment in patients with chronic stroke receiving botulinum toxin type A therapy. METHODS Eighteen chronic stroke patients were randomly assigned to receive BTT (n = 7) or FTT (n = 11) as adjunct to botulinum toxin type A therapy. A total of twelve 40-minute sessions (3 sessions/week for 4 weeks) of either BTT or FTT were conducted. A blinded assessor evaluated the patients before and after treatment. The primary outcome was the 10-meter Walking Test (10 MWT). Secondary outcomes were the modified Ashworth Scale, gait analysis, and stabilometric assessment. RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. CONCLUSIONS Greater improvement in gait and balance was noted after BTT than after FTT as an adjunct to botulinum toxin therapy in patients with chronic stroke.",2020,"RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. ","['patients with chronic stroke receiving botulinum toxin type A therapy', 'Eighteen chronic stroke patients', 'patients with chronic stroke']","['BTT or FTT', 'BTT', 'backward treadmill training (BTT) versus standard forward treadmill training (FTT', 'backward treadmill training and botulinum toxin type', 'botulinum toxin type A therapy', 'Botulinum toxin type A', 'FTT', 'botulinum toxin therapy']","['length of CoP', 'stabilometric assessment [length of centre of pressure CoP', 'modified Ashworth Scale, gait analysis, and stabilometric assessment', '10\u200aMWT', '10-meter Walking Test (10\u200aMWT', 'gait and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.0763676,"RESULTS Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment. ","[{'ForeName': 'Munari', 'Initials': 'M', 'LastName': 'Daniele', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Serina', 'Initials': 'S', 'LastName': 'Anna', 'Affiliation': 'Department of Neurosciences, Neuromotor and Cognitive Rehabilitation Centre, Physical and Rehabilitation Medicine Section, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Disarò', 'Initials': 'D', 'LastName': 'Jacopo', 'Affiliation': 'Department of Neurosciences, Neuromotor and Cognitive Rehabilitation Centre, Physical and Rehabilitation Medicine Section, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Modenese', 'Initials': 'M', 'LastName': 'Angela', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Filippetti', 'Initials': 'F', 'LastName': 'Mirko', 'Affiliation': 'Department of Neurosciences, Neuromotor and Cognitive Rehabilitation Centre, Physical and Rehabilitation Medicine Section, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Gandolfi', 'Initials': 'G', 'LastName': 'Marialuisa', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Smania', 'Initials': 'S', 'LastName': 'Nicola', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Picelli', 'Initials': 'P', 'LastName': 'Alessandro', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203067'] 2024,32508363,Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder at Any Phase of Illness and at least Mild Symptom Severity.,"Objectives To sequentially study the effectiveness of lithium and divalproex monotherapy and adjunctive therapy with quetiapine or lamotrigine in the acute and continuation treatment of bipolar I or II disorder at any phase of illness and at least mild symptom severity. Methods From June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3 were randomized to receive lithium or divalproex monotherapy for 2 weeks. Patients who had CGI-S-depression ⩾ 3 for 2 weeks at any time after 2-week monotherapy were randomly assigned to receive quetiapine or lamotrigine, or remaining on monotherapy for a total of 26 weeks. Results The rates of early termination due to lack of efficacy and side effects and changes in BISS (Bipolar Inventory of Symptoms Scale) and CGI-S total score were not significantly different between lithium and divalproex. The completion rate was significantly higher with adjunctive therapy than with monotherapy. BISS and CGI-S total scores, and their sub-scores were significantly reduced with adjunctive therapy compared to monotherapy. Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), and the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7). Patients who did not need the 2nd randomization and remained on monotherapy had a significantly reduced hazard for discontinuation (hazard ratio = 3.8). Conclusions The efficacy of lithium and divalproex as monotherapy was modest. Adjunctive lamotrigine and quetiapine to either one was well-tolerated and equally effective in reducing bipolar symptomatology, but adjunctive therapy should be initiated as early as possible when depression symptoms are present.",2020,"Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), and the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7).","['bipolar I or II disorder at any phase of illness and at least mild symptom severity', 'Patients who had CGI-S-depression ⩾ 3 for 2 weeks at any time after 2-week monotherapy', 'Methods\n\n\nFrom June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3']","['lithium and divalproex', 'quetiapine or lamotrigine', 'divalproex', 'lithium and divalproex monotherapy', 'lithium or divalproex monotherapy', 'quetiapine or lamotrigine, or remaining on monotherapy', 'Adjunctive lamotrigine and quetiapine']","['BISS and CGI-S total scores, and their sub-scores', 'bipolar symptomatology', 'survival times', 'completion rate', 'rates of early termination due to lack of efficacy and side effects and changes in BISS (Bipolar Inventory of Symptoms Scale) and CGI-S total score']","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0500405,"Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), and the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7).","[{'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Jodi G', 'Initials': 'JG', 'LastName': 'Arnold', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Prihoda', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Quinones', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Schinagle', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Conroy', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': ""D'Arcangelo"", 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Yuanhan', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': ""Gao, MD, PhD, Schinagle, MD, Calabrese, MD, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Case Western Reserve University School of Medicine, Cleveland, Ohio. Arnold, PhD, Bowden, MD, Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Prihoda, PhD, Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. Quinones, MD, IKARE Mood, Trauma, and Recovery Clinic, San Antonio, Texas. Singh, MD, Department of Psychiatry, Texas Tech University Health Sciences Center at El Paso, El Paso, Texas. Conroy, MPH, D'Arcangelo, MSW, Case Western Reserve University School of Medicine. Cleveland, Ohio. Bai, MD, MS, Mood and Anxiety Clinic in the Mood Disorders Program, Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, and Shenzhen Kangning Hospital, Shenzhen, Guandong Province, China.""}]",Psychopharmacology bulletin,[] 2025,32508377,Postactivation potentiation effect of two lower body resistance exercises on repeated jump performance measures.,"This study examined the postactivation potentiation effects of combining squat and deadlift exercises on subsequent repeated jump performance. Fifteen, resistance-trained youth wrestlers were randomly allocated to either undertake back squats (BSq), deadlift (DL) or BSq and DL as supersets (BSq+DL), with a repeated jump protocol performed 8-minutes post-exercise in each session. Thereafter, a control condition (CON) was completed involving a general warm-up, followed by the repeated jump protocols. Power outputs, flight time, contact time and reactive strength index were recorded from each repeated jump protocol. Measures were compared between the BSq, DL and BSq+DL sessions and between sessions that generated the best power output (BEST) with CON via inferential statistics and effect size (ES) calculations. The BSq condition exhibited significantly greater power output compared to the CON condition (p<0.05, ES = 1.07), although no differences were identified for the other conditioning activities. Furthermore, power output, flight time and reactive strength index were significantly greater for the BEST compared to the CON condition (p<0.05, ES = 0.97-1.47). Results indicated that BSq was the optimal conditioning activity to increase power output during a repeated jump protocol. However, greater improvement during the BEST condition suggests that the type of conditioning activity should also be considered on an individual-basis.",2020,"The BSq condition exhibited significantly greater power output compared to the CON condition (p<0.05, ES = 1.07), although no differences were identified for the other conditioning activities.","['Fifteen, resistance-trained youth wrestlers']","['two lower body resistance exercises', 'undertake back squats (BSq), deadlift (DL) or BSq and DL as supersets (BSq+DL), with a repeated jump protocol performed 8-minutes post-exercise', 'combining squat and deadlift exercises']","['best power output (BEST) with CON via inferential statistics and effect size (ES) calculations', 'power output, flight time and reactive strength index', 'Power outputs, flight time, contact time and reactive strength index']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15.0,0.0159951,"The BSq condition exhibited significantly greater power output compared to the CON condition (p<0.05, ES = 1.07), although no differences were identified for the other conditioning activities.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'Mehdi A', 'Initials': 'MA', 'LastName': 'Moghadam', 'Affiliation': 'Sport Sciences Department, Literature & Human Sciences Faculty, Lorestan University, Khorramabad, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Hoseininejad', 'Affiliation': 'Sport Sciences Department, Literature & Human Sciences Faculty, Lorestan University, Khorramabad, Iran.'}, {'ForeName': 'Vahid V', 'Initials': 'VV', 'LastName': 'Dehnou', 'Affiliation': 'Sport Sciences Department, Literature & Human Sciences Faculty, Lorestan University, Khorramabad, Iran.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Connor', 'Affiliation': 'College of Healthcare Sciences, Division of Tropical Health & Medicine, James Cook University, Townsville, Australia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Sciences, Division of Tropical Health & Medicine, James Cook University, Townsville, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Centre of Excellence for Coaches Education and Sport Science, Department of Sport, Exercise, Recreation and Kinesiology, East Tennessee State University, Tennessee, USA.'}]",Biology of sport,['10.5114/biolsport.2020.93034'] 2026,32502050,Effect of video-guided educational intervention on school engagement of adolescent students with hearing impairment: Implications for health and physical education.,"BACKGROUND/OBJECTIVE Hearing impaired students still face stigmatization and marginalization especially in inclusive classrooms in developing regions. This negatively impacts their school engagement. The present study aimed at ascertaining the effect of video-guided educational intervention on school engagement of hearing impaired students. METHOD Randomized controlled trial design was adopted for the present study. A total of 46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study. The students were randomly assigned to groups - intervention group and care-as-usual control group. A video-guided educational intervention package which consists of 13-minutes captioned video clips with school engagement themes served as the treatment intervention. Data were collected at 3 different times (pre-test, post-test and follow up) using School Engagement Scale created by Fredericks, Blumenfeld, Friedel and Paris (2005). Data were analyzed using independent sample t-test, paired sample t-test, Cohen d and Chi-square. RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = -9.305, P < .001; Emotional: t(24) = -7.772, P < .001; Cognitive: t(24) = -7.330 P < .001) as well as total student engagement (t(24) = 12.022, P < .001, Δ = 5.362). Also, the students who took part in the video-guided educational intervention maintained improved school engagement at follow-up. CONCLUSION Video-guided educational intervention is an effective intervention for improving school engagement of hearing impaired adolescent students. Since acquiring relevant education is essential for leading a quality life especially among the special needs population, it was recommended that students with hearing impairment should be helped to acquire life skills through education by fostering their school engagement.",2020,"RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","['students with hearing impairment', 'hearing impaired adolescent students', '46 junior secondary school students with hearing impairment and low school engagement symptoms participated in this study', 'school engagement of hearing impaired students', 'adolescent students with hearing impairment']","[' intervention group and care-as-usual control group', 'video-guided educational intervention', 'Video-guided educational intervention']","['total student engagement', 'school engagement level', 'school engagement']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0308663,"RESULTS Results showed that the video-guided educational intervention significantly improved school engagement level among hearing impaired adolescent students in the intervention group in comparison with the students in the care-as-usual control group as measured by the Student Engagement Scale [Behavioral: t(24) = ","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Ngozi O', 'Initials': 'NO', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': 'Department Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': 'Department of Sociology/Criminology and Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria.'}, {'ForeName': 'Chinedozie', 'Initials': 'C', 'LastName': 'Uwakwe', 'Affiliation': 'Department of Arts Education.'}, {'ForeName': 'Benedict C', 'Initials': 'BC', 'LastName': 'Eze', 'Affiliation': 'Department of Arts Education.'}]",Medicine,['10.1097/MD.0000000000020643'] 2027,32503395,Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care.,"This study evaluates the impact of a 6-month care management intervention for 206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices. Practices were cluster-randomized to Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC). Chart reviews documented higher rates of service delivery, prescription of medication for ADHD, and titration in DOCC (vs EUC). Based on complex conditional models, DOCC showed greater acute improvement in individualized ADHD treatment goals and follow-up improvements in quality of life and ADHD and oppositional defiant disorder goals. Medication use had a significant effect on acute and follow-up ADHD symptom reduction and quality of life. Medication continuity was associated with some long-term gains. A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.",2020,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"['Children', 'Comorbid Attention Deficit Hyperactivity Disorder', '206 children diagnosed with comorbid attention deficit hyperactivity disorder (ADHD) from a sample of 321 five- to 12-year-old children recruited for treatment of behavior problems in 8 pediatric primary care offices']","['Collaborative Care', 'care management intervention', 'Doctor Office Collaboration Care (DOCC) or Enhanced Usual Care (EUC']","['quality of life and ADHD and oppositional defiant disorder goals', 'acute and follow-up ADHD symptom reduction and quality of life', 'Medication continuity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}]",206.0,0.0862828,A collaborative care intervention for behavior problems that incorporated treatment guidelines for ADHD in primary care was more effective than psychoeducation and facilitated referral to community treatment.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Hart', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campo', 'Affiliation': 'Ohio State University, Morgantown, WV, USA.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rounds', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Wolraich', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Clinical pediatrics,['10.1177/0009922820920013'] 2028,32503465,Feasibility and safety of high-intensity interval training for the rehabilitation of geriatric inpatients (HIITERGY) a pilot randomized study.,"BACKGROUND High-intensity interval training (HIIT) has been shown to be more effective than moderate-intensity continuous training (MICT) for the physical rehabilitation. However, data on its suitability for older hospitalized patients is scarce. METHODS Randomized controlled trial in a hospital setting. Inclusion of 100 patients, ≥65 years old, hospitalized for rehabilitation after an acute medical condition, in a two-week rehabilitation program of either four HIIT or three MICT sessions per week. Completion was defined as participation in all but two planned sessions accomplishing ≥50% of each session. We assessed: upper-limb muscle strength (handgrip isometric strength test), lower-limb muscle strength (quadriceps and ankle flexion and extension tests); gait speed and spatio-temporal parameters (instrumented walkway), and exercise capacity (6-min walk test). All adverse events were recorded as safety endpoints. RESULTS An intention-to-treat analysis showed a 44% completion rate for the HIIT group (95% CI, 30-59) and 77% for MICT (95% CI, 55-82). A modified intention-to-treat analysis restricted to patients who participated in ≥1 session showed an 88% completion rate in the HIIT group (95%CI, 69-97) and an 80% completion rate in MICT (95%CI, 65-90). The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%). There were no significant differences in the various measures. No serious adverse events occurred. CONCLUSION A HIIT rehabilitation program for this population was feasible, safe and had a high adherence rate. TRIAL REGISTRATION NUMBER Clinicatrials.gov ID: NCT02318459. Trial registration date: November 7th, 2014. Retrospectively registered. This study adheres to the CONSORT guidelines.",2020,The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%).,"['100 patients, ≥65\u2009years old, hospitalized for rehabilitation after an acute medical condition, in a two-week rehabilitation program of either four HIIT or three MICT sessions per week', 'geriatric inpatients (HIITERGY', 'older hospitalized patients']","['high-intensity interval training', 'High-intensity interval training (HIIT', 'MICT']","['Feasibility and safety', 'upper-limb muscle strength (handgrip isometric strength test), lower-limb muscle strength (quadriceps and ankle flexion and extension tests); gait speed and spatio-temporal parameters (instrumented walkway), and exercise capacity (6-min walk test']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",,0.141577,The exercises most frequently undertaken were the pedal exerciser (54%) and the NuStep (32%).,"[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pires Peixoto', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Trombert', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Poncet', 'Affiliation': 'Division of clinical epidemiology, Geneva University Hospitals and Geneva Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Kizlik', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gold', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ehret', 'Affiliation': 'Division of Cardiology, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Trombetti', 'Affiliation': 'Division of Bone Diseases, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Reny', 'Affiliation': 'Division of Internal Medicine for the elderly, Trois-Chêne, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. jean-luc.reny@hcuge.ch.'}]",BMC geriatrics,['10.1186/s12877-020-01596-7'] 2029,32503469,INFORM2 NivEnt: The first trial of the INFORM2 biomarker driven phase I/II trial series: the combination of nivolumab and entinostat in children and adolescents with refractory high-risk malignancies.,"BACKGROUND Pediatric patients with relapsed or refractory disease represent a population with a desperate medical need. The aim of the INFORM (INdividualized Therapy FOr Relapsed Malignancies in Childhood) program is to translate next generation molecular diagnostics into a biomarker driven treatment strategy. The program consists of two major foundations: the INFORM registry providing a molecular screening platform and the INFORM2 series of biomarker driven phase I/II trials. The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II). METHODS This is an exploratory non-randomized, open-label, multinational and multicenter seamless phase I/II trial in children and adolescents with relapsed / refractory or progressive high-risk solid tumors and CNS tumors. The phase I is divided in 2 age cohorts: 12-21 years and 6-11 years and follows a 3 + 3 design with two dose levels for entinostat (2 mg/m 2 and 4 mg/m 2 once per week) and fixed dose nivolumab (3 mg/kg every 2 weeks). Patients entering the trial on RP2D can seamlessly enter phase II which consists of a biomarker defined four group basket trial: high mutational load (group A), high PD-L1 mRNA expression (group B), focal MYC(N) amplification (group C), low mutational load and low PD-L1 mRNA expression and no MYC(N) amplification (group D). A Bayesian adaptive design will be used to early stop cohorts that fail to show evidence of activity. The maximum number of patients is 128. DISCUSSION This trial intends to exploit the immune enhancing effects of entinostat on nivolumab using an innovative biomarker driven approach in order to maximize the chance of detecting signs of activity. It prevents exposure to unnecessary risks by applying the Bayesian adaptive design for early stopping for futility. The adaptive biomarker driven design provides an innovative approach accelerating drug development and reducing exposure to investigational treatments in these vulnerable children at the same time. TRIAL REGISTRATION ClinicalTrials.gov, NCT03838042. Registered on 12 February 2019.",2020,"The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II). ","['Pediatric patients with relapsed or refractory disease represent a population with a desperate medical need', 'children and adolescents with refractory high-risk malignancies', 'children and adolescents with relapsed / refractory or progressive high-risk solid tumors and CNS tumors', '2 age cohorts: 12-21\u2009years and 6-11\u2009years']","['entinostat (2\u2009mg/m 2 and 4\u2009mg/m 2 once per week) and fixed dose nivolumab', 'nivolumab and entinostat', 'INFORM2', 'high PD-L1 mRNA expression']",['activity and safety (phase II'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0085136', 'cui_str': 'Neoplasm of central nervous system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2743752', 'cui_str': 'entinostat'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",,0.0548795,"The INFORM2 NivEnt trial aims to determine the recommended phase 2 dose (RP2D) of the combination treatment of nivolumab and entinostat (phase I) and to evaluate activity and safety (phase II). ","[{'ForeName': 'Cornelis M', 'Initials': 'CM', 'LastName': 'van Tilburg', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany. cornelis.vantilburg@kitz-heidelberg.de.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Witt', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Heiss', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Kristian W', 'Initials': 'KW', 'LastName': 'Pajtler', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Plass', 'Affiliation': 'Division of Cancer Epigenomics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Poschke', 'Affiliation': 'DKTK Immune Monitoring Unit, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'DKTK Immune Monitoring Unit, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Harting', 'Affiliation': 'Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sedlaczek', 'Affiliation': 'Radiology Cooperation Uni/DKFZ, Division of Radiology, NCT, Heidelberg, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Freitag', 'Affiliation': 'NCT Trial Center, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meyrath', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Pharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gnana Prakash', 'Initials': 'GP', 'LastName': 'Balasubramanian', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Division of Pediatric Neurooncology, German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jäger', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Division of Pediatric Neurooncology, German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Pfaff', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Department of Pediatric Hematology and Oncology, Heidelberg University Hospital, Heidelberg, Germany.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Jones', 'Affiliation': ""Hopp Children's Cancer Center Heidelberg (KiTZ), Department of Pediatric Hematology and Oncology, Heidelberg University Hospital, Heidelberg, Germany.""}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Milde', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pfister', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}, {'ForeName': 'David T W', 'Initials': 'DTW', 'LastName': 'Jones', 'Affiliation': ""Pediatric Glioma Research Group, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and German Cancer Consortium (DKTK), Heidelberg, Germany.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Kopp-Schneider', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Witt', 'Affiliation': ""KiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.""}]",BMC cancer,['10.1186/s12885-020-07008-8'] 2030,32503473,The effect of physical activity on cognition relative to APOE genotype (PAAD-2): study protocol for a phase II randomized control trial.,"BACKGROUND By 2050, the prevalence of Alzheimer's disease (AD) in the United States is predicted to reach 13.8 million. Despite worldwide research efforts, a cure for AD has not been identified. Thus, it is critical to identify preventive strategies that can reduce the risk of or delay the onset of AD. Physical activity (PA) has potential in this regard. This randomized clinical trial aims to (a) test the causal relationship between PA and AD-associated cognitive function for persons with a family history of AD (FH+), (b) determine the moderating role of apolipoprotein epsilon 4 (APOE4) carrier status on cognition, and (c) assess cerebral structure, cerebral function, and putative biomarkers as mediators of the effects of PA on cognition. METHODS We are recruiting cognitively normal, middle aged (40-65 years) sedentary adults with FH+. Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle. Saliva samples are taken at pre-test to determine APOE genotype. At pre-, mid-, and post-tests, participants complete a series of cognitive tests to assess information-processing speed, verbal and visual episodic memory, constructional praxis, mnemonic discrimination, and higher-order executive functions. At pre- and post-tests, brain imaging and blood biomarkers are assessed. DISCUSSION We hypothesize that 1) the PA group will demonstrate improved cognition compared with controls; 2) PA-derived cognitive changes will be moderated by APOE4 status; and 3) PA-induced changes in neural and blood biomarkers will contribute to cognitive changes and differ as a function of APOE4 status. Our results may provide important insights into the potential of PA to preserve neurocognitive function in people with a heightened risk of AD due to FH+ and as moderated by APOE4 status. By using sophisticated analytic techniques to assess APOE as a moderator and neurobiological mechanisms as mediators across trajectories of cognitive change in response to PA, we will advance our understanding of the potential of PA in protecting against AD. TRIAL REGISTRATION ClinicalTrials.gov NCT03876314. Registered March 15, 2019.",2020,Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle.,"['persons with a family history of AD (FH', 'cognitively normal, middle aged (40-65\u2009years) sedentary adults with FH']","['control group maintaining their normal lifestyle', 'PA intervention', 'physical activity', 'PA and AD-associated cognitive function']","['Physical activity (PA', 'information-processing speed, verbal and visual episodic memory, constructional praxis, mnemonic discrimination, and higher-order executive functions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1271045', 'cui_str': ""FH: Alzheimer's disease""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0760556,Participants are randomly assigned to a 12-month PA intervention for 3 days/week or to a control group maintaining their normal lifestyle.,"[{'ForeName': 'Kyoung Shin', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Ganesh', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Nathaniel T', 'Initials': 'NT', 'LastName': 'Berry', 'Affiliation': 'Under Armour, Baltimore, MD, 21209, USA.'}, {'ForeName': 'Yashonda P', 'Initials': 'YP', 'LastName': 'Mobley', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Karper', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Wahlheim', 'Affiliation': 'Department of Psychology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Tomika M', 'Initials': 'TM', 'LastName': 'Williams', 'Affiliation': 'Department of Advanced Nursing Practice and Education, East Carolina University, Greenville, NC, 27858, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Wideman', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, NC, 27402, USA. jletnier@uncg.edu.'}]",BMC neurology,['10.1186/s12883-020-01732-1'] 2031,32503663,Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeostasis in the lung with acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. Sargramostim is a man-made form of the naturally-occurring protein GM-CSF. TRIAL DESIGN A phase 4 academic, prospective, 2 arm (1:1 ratio), randomized, open-label, controlled trial. PARTICIPANTS Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen. Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels > 2000 μg/mL. INTERVENTION AND COMPARATOR Inhaled sargramostim 125 μg twice daily for 5 days in addition to standard care. Upon progression of disease requiring mechanical ventilation or to acute respiratory distress syndrome (ARDS) and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125 μg/m 2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. Intervention will be compared to standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards in the standard of care group will have the option (clinician's decision) to initiate IV sargramostim 125m μg/m 2 body surface area once daily for 5 days. MAIN OUTCOMES The primary endpoint of this intervention is measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen). RANDOMISATION Patients will be randomized in a 1:1 ratio. Randomization will be done using REDCap (electronic IWRS system). BLINDING (MASKING) In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group. TRIAL STATUS SARPAC protocol Version 2.0 (April 15 2020). Participant recruitment is ongoing in 5 Belgian Hospitals (i.e. University Hospital Ghent, AZ Sint-Jan Bruges, AZ Delta Roeselare, University Hospital Brussels and ZNA Middelheim Antwerp). Participant recruitment started on March 26 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment. TRIAL REGISTRATION The trial was registered on Clinical Trials.gov on March 30 th , 2020 (ClinicalTrials.gov Identifier: NCT04326920) - retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT on March 24th, 2020 (Identifier: 2020-001254-22). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a', 'on March 24th, 2020', 'Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels ', '2000', 'patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC', '80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group']","['https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT', 'Sargramostim', 'Inhaled sargramostim', 'PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen']","['measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0232010', 'cui_str': 'Alveolar pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",80.0,0.333777,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04451-7'] 2032,32503727,Adenosine A2A receptor agonist (regadenoson) in human lung transplantation.,"BACKGROUND Currently, there are no clinically approved treatments for ischemia-reperfusion injury after lung transplantation. Pre-clinical animal models have demonstrated a promising efficacy of adenosine 2A receptor (A 2A R) agonists as a treatment option for reducing ischemia-reperfusion injury. The purpose of this human study, is to conduct a Phase I clinical trial for evaluating the safety of continuous infusion of an A 2A R agonist in lung transplant recipients. METHODS An adaptive, two-stage continual reassessment trial was designed to evaluate the safety of regadenoson (A 2A R agonist) in the setting of lung transplantation. Continuous infusion of regadenoson was administered to lung transplant recipients that was started at the time of skin incision. Adverse events and dose-limiting toxicities, as pre-determined by a study team and assessed by a clinical team and an independent safety monitor, were the primary end-points for safety in this trial. RESULTS Between January 2018 and March 2019, 14 recipients were enrolled in the trial. Of these, 10 received the maximum infused dose of 1.44 µg/kg/min for 12 hours. No dose-limiting toxicities were observed. The steady-state plasma regadenoson levels sampled before the reperfusion of the first lung were 0.98 ± 0.46 ng/ml. There were no mortalities within 30 days. CONCLUSIONS Regadenoson, an A 2A R agonist, can be safely infused in the setting of lung transplantation with no dose-limiting toxicities or drug-related mortality. Although not powered for the evaluation of secondary end-points, the results of this trial and the outcome of pre-clinical studies warrant further investigation with a Phase II randomized controlled trial.",2020,"There were no mortalities within 30 days. ","['lung transplant recipients', 'Between January 2018 and March 2019, 14 recipients were enrolled in the trial', 'human lung transplantation']","['2A R agonist', 'regadenoson', 'regadenoson (A 2A R agonist', 'Adenosine A2A receptor agonist (regadenoson']","['No dose-limiting toxicities', 'steady-state plasma regadenoson levels', 'Adverse events and dose-limiting toxicities']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1698215', 'cui_str': 'regadenoson'}, {'cui': 'C2936552', 'cui_str': 'Adenosine A2A Receptor Agonists'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1698215', 'cui_str': 'regadenoson'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",14.0,0.0547169,"There were no mortalities within 30 days. ","[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, University of Maryland, Baltimore, Maryland. Electronic address: CLLau@som.umaryland.edu.'}, {'ForeName': 'Jared P', 'Initials': 'JP', 'LastName': 'Beller', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Boys', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Department of Surgery, University of California, San Diego, California.'}, {'ForeName': 'Yunge', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Surgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cosner', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Charles', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Mehaffey', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Mannem', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Irving L', 'Initials': 'IL', 'LastName': 'Kron', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia; Department of Surgery, University of Arizona Health Sciences, Tucson, Arizona.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Krupnick', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Linden', 'Affiliation': 'Division of Developmental Immunology, La Jolla Institute for Immunology and Department of Pharmacology, University of California, San Diego, California.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.02.003'] 2033,32503866,Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.,"INTRODUCTION Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.",2020,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","['peripheral artery disease', 'patients with PAD', '1760 patients diagnosed with PAD at Fontaine stage II']","['Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach', 'usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle', 'TeGeCoach or care-as-usual', 'TeGeCoach']","['walking ability based on the Walking Impairment Questionnaire', 'quality of life, health literacy and health behaviour', 'walking impairment']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",1760.0,0.109017,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany f.rezvani@uke.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bienert', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kramer', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Steinisch', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Freudenstein', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Terhalle', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Grosse', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bock', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Posselt', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Beutel', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Reif', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kirchhoff', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Neuschwander', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Löffler', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brunner', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dickmeis', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenthal', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Daniela Patricia', 'Initials': 'DP', 'LastName': 'Chase', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seelenmeyer', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Mark Dominik', 'Initials': 'MD', 'LastName': 'Alscher', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Department of Sports Medicine, Hannover Medical School, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032146'] 2034,32503867,"Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application.","INTRODUCTION With the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing. METHODS AND ANALYSIS Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later. ETHICS AND DISSEMINATION This protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER ClinicalTrials.gov registry (NCT03793946). Stage; pre-results.",2020,"METHODS AND ANALYSIS Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","['hospitals', 'At participating wards, patients of at least 18 years of age using antimicrobials will be included']","['smartphone-based digital stewardship applications', 'digital antimicrobial stewardship smartphone application']","['antimicrobial use metrics, clinical and process outcomes']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",15.0,0.275037,"METHODS AND ANALYSIS Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Helou', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gaud', 'Initials': 'G', 'LastName': 'Catho', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Peyravi Latif', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hulscher', 'Affiliation': 'Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conly', 'Affiliation': 'Department of Medicine, University of Calgary and Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Benedikt D', 'Initials': 'BD', 'LastName': 'Huttner', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tängdén', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands a.verbon@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-033640'] 2035,32509699,"Effect of combined aquatic and cognitive training on quality of life, fall self-efficacy, and motor performance in aged with varying cognitive status: a proof-of-concept study.","With the increasing number of aged individuals, research pertaining to their cognitive functions and physical-motor has become exponentially imperative. The purpose of the study was to investigate the effect com-bined aquatic and cognitive training on quality of life (QoL), fall self-effi-cacy and motor performance (static and dynamic balance) in aged with varying cognitive status levels. Thirty participants were assigned to a high cognitive status group (n=10), low cognitive status group (n=10), or nonintervention control group (n=10). Participants completed a 6-week motor-cognitive training regime with increasing intensity. QoL, fall self-efficacy, static balance, and dynamic balance were assessed. Preliminary results suggest proof-of-concept significant ( P <0.05) im-provements were found in both the high and low cognitive status groups for static and dynamic balance and fall self-efficacy. However, QoL was only found to be significantly improved in the low cognitive status group. Aqua training along with cognitive training can effectively be used to prevent falls in the elderly and to improve their physical-motor perfor-mance. However, when attempting to improve QoL, the cognitive status of the individual should be considered.",2020,Aqua training along with cognitive training can effectively be used to prevent falls in the elderly and to improve their physical-motor perfor-mance.,"['Thirty participants were assigned to a high cognitive status group (n=10', 'aged with varying cognitive status', 'aged with varying cognitive status levels']","['combined aquatic and cognitive training', 'low cognitive status group', 'bined aquatic and cognitive training', '6-week motor-cognitive training regime with increasing intensity', 'nonintervention control group', 'Aqua training along with cognitive training']","['QoL, fall self-efficacy, static balance, and dynamic balance', 'quality of life, fall self-efficacy, and motor performance', 'quality of life (QoL), fall self-effi-cacy and motor performance (static and dynamic balance', 'static and dynamic balance and fall self-efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574497', 'cui_str': 'Edo language'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",30.0,0.0101941,Aqua training along with cognitive training can effectively be used to prevent falls in the elderly and to improve their physical-motor perfor-mance.,"[{'ForeName': 'Mahnoosh Salari', 'Initials': 'MS', 'LastName': 'Nahand', 'Affiliation': 'Department of Pedagogy, Farhangian University, Alborz, Iran.'}, {'ForeName': 'Mahboubeh Ghayour', 'Initials': 'MG', 'LastName': 'Najafababdi', 'Affiliation': 'Department of Motor Behavior, Faculty of Physical Education and Sport Science, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Naghdi', 'Affiliation': 'Department of Physiology and Pharmacology, Pasteur Institute of Iran, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Sheikh', 'Affiliation': 'Department of Motor Behavior, Faculty of Physical Education and Sport Science, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Brandon S', 'Initials': 'BS', 'LastName': 'Shaw', 'Affiliation': 'Department of Human Movement Science, University of Zululand, KwaDlangezwa, South Africa.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040076.038'] 2036,32509700,"Effect of playing soccer on stress, sociality, and physical fitness in alienated youth: a retrospective study.","This study was to analyze bullying experiences, physical fitness, and stress and social support in young students who have taken part in a soccer program for approximately 3 years. Fifty-two participants who were divided into two groups: a control group that had not experienced alienation (NAG; n=45, 86.5%) and an experimental group that had ex-perienced alienation (AG; n=7, 13.5%). The frequency of alienation in AG was '1-2 times' or 'a few times' per week. NAG believed their in-volvement in the soccer program helped them improve their relation-ships with friends, cope with alienation, and overcome bullying. Muscle mass and basal metabolic rate of NAG showed higher levels than those of AG. Strength of NAG was significantly higher than that of AG. Stress levels of NAG were significantly lower than those of AG. Although so-cial support was not significantly different between groups, there was a higher tendency in NAG to have stronger social support compared to AG. In conclusion, this study suggests that physical fitness and stress levels can be improved by playing soccer. In particular, participating in a soccer program for an extended period of time can benefit individuals who are socially alienated.",2020,"Although so-cial support was not significantly different between groups, there was a higher tendency in NAG to have stronger social support compared to AG.","['Fifty-two participants who were divided into two groups: a control group that had not experienced alienation (NAG; n=45, 86.5%) and an experimental group that had ex-perienced alienation (AG; n=7, 13.5', 'young students who have taken part in a soccer program for approximately 3 years', 'alienated youth']",['playing soccer'],"['stress, sociality, and physical fitness', 'Stress levels of NAG', 'frequency of alienation in AG', 'Muscle mass and basal metabolic rate', 'Strength of NAG', 'bullying experiences, physical fitness, and stress and social support']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1431698', 'cui_str': 'NAG protein, human'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C1431698', 'cui_str': 'NAG protein, human'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",52.0,0.0141771,"Although so-cial support was not significantly different between groups, there was a higher tendency in NAG to have stronger social support compared to AG.","[{'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Physical Education, Chungbuk National University, Chungju, Korea.'}, {'ForeName': 'Jaewan', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan, Korea.'}, {'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Yoo', 'Affiliation': 'Department of Health and Human Performance, Sahmyook University, Seoul, Korea.'}, {'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan, Korea.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040156.078'] 2037,32509702,A temporary forward head posture decreases function of cervical proprioception.,"Increased use of smartphones can cause abnormal alignment of head and neck, resulting in forward head posture (FHP). This can lead to change in the structures and function of the cervical vertebrae. The purpose of this study was to determine the impact on deep neck flexor muscles, proprioception, vestibular function, and balance of subjects with induced FHP by using smartphone. Twenty-two healthy persons were randomly divided into two groups. The FHP group maintained a craniovertebral angle (CVA) of <49° and a normal head posture group maintained a CVA of >50° watching the smartphone for 40 min. We measured the area of the longus colli and longus capitis muscles, cervical joint position sense, Romberg test, subjective visual vertical test, and subjective visual horizontal test. There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups. However, there was a significant difference in the cervical proprioception ( P <0.05). Proprioception may be considered to be the most influential factor in induced FHP by smartphone viewing.",2020,"There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups.","['subjects with induced FHP by using smartphone', 'Twenty-two healthy persons']","['normal head posture group maintained a CVA of >50° watching the smartphone', 'FHP']","['deep neck flexor muscles, vestibular function, and static balance', 'cervical proprioception', 'deep neck flexor muscles, proprioception, vestibular function, and balance', 'area of the longus colli and longus capitis muscles, cervical joint position sense, Romberg test, subjective visual vertical test, and subjective visual horizontal test']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439780', 'cui_str': 'Forward'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0224169', 'cui_str': 'Longus colli muscle structure'}, {'cui': 'C0224107', 'cui_str': 'Structure of longus capitis muscle'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0278127', 'cui_str': 'Romberg sign'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",22.0,0.0156369,"There was no significant difference in the deep neck flexor muscles, vestibular function, and static balance between the groups.","[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ha', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Changwon, Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Sung', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Changwon, Korea.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040106.053'] 2038,32506228,Alteration of Streptococcus salivarius in Buccal Mucosa of Oral Lichen Planus and Controlled Clinical Trial in OLP Treatment.,"Oral lichen planus (OLP) is a T cell-mediated common chronic inflammatory mucosal disease, with limited therapies available for long-term use. Previous study showed that ratio of genus Streptococcus decreased significantly in OLP patients when compared with controls. Buccal cotton swab samples of 43 OLP patients and 48 healthy individuals were collected for real-time quantitative polymerase chain reaction (RT-PCR) to investigate relative abundance alteration of Streptococcus salivarius in OLP lesions. Bacterial supernatants of S. salivarius ATCC® BAA-2593™ were collected by centrifugation and added to HSC-3 cells, and quantitative analysis of expression of IL-1β, IL-6, IL-8, and TNF-α in the HSC-3 cells was determined by RT-PCR. Then, a randomized, non-blinded, controlled study was conducted. Forty patients with symptomatic OLP were randomly allocated into two groups and received topical treatment of 0.1% triamcinolone acetonide dental paste (group A) and S. salivarius K12 lozenge (group B), respectively, for 4 weeks. Sign scores, visual analogue scale (VAS), and adverse reactions were recorded. Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05). After treated with 0.1% supernatants of S. salivarius ATCC® BAA-2593™, the expression level of IL-6 in the HSC-3 cells significantly reduced (P < 0.001), while IL-1β, IL-8, and TNF- α showed a decreasing tendency (P > 0.05). There was significant reduction in sign scores and VAS scores in both groups after the 4-week treatment, with no significant difference between two groups. No adverse reaction was observed. S. salivarius might maintain local immune balance by inhibiting the NF-κB pathway. Topical application of Streptococcus salivarius K12 seemed to be effective in treatment of symptomatic OLP, especially with promising potential in long-term use. More detailed clinical studies with long follow-up period and standardized usage/dosage are expected to acquire definite conclusions.",2020,Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05).,"['Forty patients with symptomatic OLP', '43 OLP patients and 48 healthy individuals']","['Oral lichen planus (OLP', 'Streptococcus salivarius', 'topical treatment of 0.1% triamcinolone acetonide dental paste (group A) and S. salivarius K12 lozenge']","['expression level of IL-6 in the HSC-3 cells', 'adverse reaction', 'ratio of genus Streptococcus', 'sign scores and VAS scores', 'Sign scores, visual analogue scale (VAS), and adverse reactions', 'Relative abundance of S. salivarius']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C4706462', 'cui_str': 'Dental paste'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",40.0,0.0766109,Relative abundance of S. salivarius in the OLP group was lower than that of control group (P < 0.05).,"[{'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Fangyang', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Saiwei', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Oral Medicine, Shanghai Engineering Research Center of Tooth Restoration and Regeneration, School & Hospital of Stomatology, Tongji University, Middle Yanchang Road 399, Shanghai, People's Republic of China, 200072. drheyuan@tongji.edu.cn.""}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09664-5'] 2039,32508386,Eight months of school-based soccer improves physical fitness and reduces aggression in high-school children.,"School-based programmes have shown promising results in the reduction of aggressive behaviour, but the effectiveness of physical activity modalities among adolescents remains to be determined. The aim of this study was to determine the effects of a school-based soccer programme on physical fitness and aggression in adolescent students. One hundred and five high school students were randomized to a small-sided soccer training group (SG) or a control group (CG). In addition to the regular physical education classes performed as part of a curriculum, the SG completed eight months of small-sided soccer training twice a week after school. Aerobic fitness (YYIR1), vertical jump (VJ), backward overhead medicine ball throw (BOMBT), and Buss and Perry's aggression questionnaire were evaluated before and after eight months of training. Greater improvements were observed in the SG than in the CG in the BOMBT (%diff=4.3, ŋ p 2 =.308) and YYIR1 tests (%diff=2.2, ŋ p 2 =.159), and physical aggression subscale (%diff=-12.1, ŋ p 2 =.144). Extra, school-based recreational soccer for adolescents was accompanied by a significant improvement in physical fitness, compared to physical education classes only. Moreover, the implementation of recreational soccer into regular physical education classes seems to be a potentially appropriate stimulus for reducing aggression in high-school students.",2020,"Aerobic fitness (YYIR1), vertical jump (VJ), backward overhead medicine ball throw (BOMBT), and Buss and Perry's aggression questionnaire were evaluated before and after eight months of training.","['One hundred and five high school students', 'high-school children', 'adolescent students']","['small-sided soccer training group (SG) or a control group (CG', 'school-based soccer programme']","['YYIR1 tests', 'physical fitness and reduces aggression', ""Aerobic fitness (YYIR1), vertical jump (VJ), backward overhead medicine ball throw (BOMBT), and Buss and Perry's aggression questionnaire"", 'BOMBT', 'physical aggression subscale', 'physical fitness', 'physical fitness and aggression']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression'}]",105.0,0.0119493,"Aerobic fitness (YYIR1), vertical jump (VJ), backward overhead medicine ball throw (BOMBT), and Buss and Perry's aggression questionnaire were evaluated before and after eight months of training.","[{'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Serbia.'}, {'ForeName': 'Dejan M', 'Initials': 'DM', 'LastName': 'Madić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Serbia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Milanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Serbia.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Padulo', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), Faculty of Health Sciences, University of Southern Denmark, Denmark.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Chamari', 'Affiliation': 'Athlete Health and Performance Research Centre, Aspetar, Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}]",Biology of sport,['10.5114/biolsport.2020.94240'] 2040,32508444,Clinicomicrobiological evaluation of the efficacy of local delivery of moxifloxacin and ibuprofen gel as an adjunct to scaling and root planing in chronic periodontitis patients.,"Aims To evaluate the clinical and microbiological effects of local drug delivery of moxifloxacin and ibuprofen gel as an adjunct to conventional periodontal therapy in chronic periodontitis patients. Subjects and Methods Twenty patients with moderate-to-severe chronic generalized periodontitis with probing pocket depth (PPD) of ≥5 mm and <8 mm were randomly assigned to one of the following two treatment modalities: scaling and root planing (SRP) group and moxifloxacin and ibuprofen combination gel as an adjunct to SRP group. Clinical parameters include plaque index (PI), gingival index (GI), probing depths and clinical attachment level (CAL) that were recorded at baseline and 1 and 3 months after the treatment, and microbiologic assessment was done using dark-field microscopy. Results A statistically significant difference in mean PI and GI scores and reduction in PPD and gain in CAL were observed at different study intervals with greater difference in the test group. On microbiological examination, the percentage of cocci increased, while a statistically significant decrease in the mean percentage of bacilli and spirochetes was observed in both groups at given intervals. In-vitro dissolution showed controlled release of both the drugs. Conclusions Among the two treatment modalities, treatment with moxifloxacin and ibuprofen local delivery as an adjunct to SRP gave superior results in clinical and microbiological parameters compared to SRP group.",2020,A statistically significant difference in mean PI and GI scores and reduction in PPD and gain in CAL were observed at different study intervals with greater difference in the test group.,"['chronic periodontitis patients', 'Subjects and Methods\n\n\nTwenty patients with moderate-to-severe chronic generalized periodontitis with probing pocket depth (PPD) of ≥5 mm and <8 mm']","['moxifloxacin', 'moxifloxacin and ibuprofen gel', 'scaling and root planing (SRP) group and moxifloxacin and ibuprofen combination gel']","['mean percentage of bacilli and spirochetes', 'percentage of cocci', 'plaque index (PI), gingival index (GI), probing depths and clinical attachment level (CAL', 'mean PI and GI scores and reduction in PPD and gain in CAL']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0037973', 'cui_str': 'Order Spirochaetales'}, {'cui': 'C0314746', 'cui_str': 'Cocci'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0396851,A statistically significant difference in mean PI and GI scores and reduction in PPD and gain in CAL were observed at different study intervals with greater difference in the test group.,"[{'ForeName': 'Ramyasri', 'Initials': 'R', 'LastName': 'Kadadasu', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Atchuta', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}, {'ForeName': 'Rajababu', 'Initials': 'R', 'LastName': 'Palaparthy', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}, {'ForeName': 'S Harinath', 'Initials': 'SH', 'LastName': 'Reddy', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}, {'ForeName': 'Vidyasagar', 'Initials': 'V', 'LastName': 'Sisinty', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}, {'ForeName': 'Mounika', 'Initials': 'M', 'LastName': 'Beeravolu', 'Affiliation': 'Department of Periodontics, Kamineni Institute of Dental Sciences, Nalgonda, Telangana, India.'}]",Journal of oral and maxillofacial pathology : JOMFP,['10.4103/jomfp.JOMFP_253_19'] 2041,32508552,Menopause uncertainty: the impact of two educational interventions among women during menopausal transition and beyond.,"Introduction Menopause is a natural part of women's lives, which is associated with physical and mental changes and can lead to uncertainty and consequent undesirable effects in the lives of menopausal women. The present study was conducted to compare the impact of multimedia and booklet educational methods on the uncertainty about menopause during this transition period. Materials and methods In a cluster randomized trial 68 women aged 45-55 years were randomly allocated into two groups: multimedia and booklet. Data were collected using knowledge and uncertainty questionnaires about menopause in three stages, i.e. before intervention, immediately after intervention (two weeks later), and one month later. Repeated-measures analysis of variance (rANOVA) was used to compare knowledge and uncertainty scores between two groups for the duration of the study. Data were analysed using SPSS software and p values < 0.05 were considered as statistically significant. Results The results of the study indicated a high level of uncertainty in both groups before the implementation of the educational program. There was no significant difference between groups in terms of knowledge and uncertainty about menopause over time ( p > 0.05). However, we found a significant increase in knowledge and a significant decrease in uncertainty scores in both groups ( p < 0.001) after the interventions. Conclusions Although the findings of this study did not show a significant difference between the effect of multimedia and booklet educational methods in postmenopausal women, the high level of uncertainty of women before intervention and its significant reduction after the implementation of the educational programs indicated the importance of education throughout this period.",2020,There was no significant difference between groups in terms of knowledge and uncertainty about menopause over time ( p > 0.05).,"['women during menopausal transition and beyond', '68 women aged 45-55 years', 'postmenopausal women']","['multimedia and booklet', 'multimedia and booklet educational methods']","['uncertainty scores', 'knowledge', 'knowledge and uncertainty about menopause over time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",68.0,0.0398475,There was no significant difference between groups in terms of knowledge and uncertainty about menopause over time ( p > 0.05).,"[{'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Afshari', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing, Gonabad University of Medical Science, Gonabad, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Bahri', 'Affiliation': 'Department of Midwifery, Faculty of Medicine, Social Development and Health Promotion Centre, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Moosa', 'Initials': 'M', 'LastName': 'Sajjadi', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing, Social Development and Health Promotion Centre, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mansoorian', 'Affiliation': 'Department of Management and Community Health Nursing, Gonabad University of Medical Sciences, Gonabad, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Tohidinik', 'Affiliation': 'HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Przeglad menopauzalny = Menopause review,['10.5114/pm.2020.95305'] 2042,32508553,Abandoning the blind legacy passed on horde of routine intra-abdominal drain insertion in cesarean section.,"Introduction Cesarean section (CS) delivery is the most common major obstetrical surgical operation carried out in and is increasing in incidence throughout the world. The major involves some risks that might include: infection, coagulation problem, loss of blood, bowel or bladder injury, abnormalities of the placenta in subsequent pregnancies. Aim of the study To evaluate the clinical effectiveness of postoperative CS intra-abdominal drain insertion. Material and methods A prospective study was conducted on 245 patients in labor, at the Department of Obstetrics and Gynecology, Jordan University Hospital, between January 2017 and January 2018. Participants were divided into two groups: group I including those who had abdominal drains insertion during surgery and group II including women who had no abdominal drain inserted before closure. All patients on both groups were term pregnancies, underwent elective vs. emergency CS, and had no subcutaneous drains inserted. Results Clinical and surgical parameters were comparable in both groups. Postoperative hospital stay was significantly shorter in group II, whereas specific postoperative complication rate was significantly higher in group I. Drain site infection was noted in 2 (1.6%), organ herniation in 2 (1.6%), drain avulsion in 2 (1.6%), severe pain at the site of insertion in 2 (1.6%) patients. Conclusions Routine prophylactic intra-abdominal drain insertion post CS has no benefits and therefore should be stopped.",2020,"Postoperative hospital stay was significantly shorter in group II, whereas specific postoperative complication rate was significantly higher in group I. Drain site infection was noted in 2 (1.6%), organ herniation in 2 (1.6%), drain avulsion in 2 (1.6%), severe pain at the site of insertion in 2 (1.6%) patients. ","['245 patients in labor, at the Department of Obstetrics and Gynecology, Jordan University Hospital, between January 2017 and January 2018', 'All patients on both groups were term pregnancies, underwent elective vs. emergency CS, and had no subcutaneous drains inserted']","['Introduction\n\n\nCesarean section (CS', 'postoperative CS intra-abdominal drain insertion', 'abdominal drains insertion during surgery and group II including women who had no abdominal drain inserted before closure']","['drain avulsion', 'Postoperative hospital stay', 'severe pain', 'specific postoperative complication rate', 'organ herniation']","[{'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0185044', 'cui_str': 'Surgical avulsion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",,0.0267501,"Postoperative hospital stay was significantly shorter in group II, whereas specific postoperative complication rate was significantly higher in group I. Drain site infection was noted in 2 (1.6%), organ herniation in 2 (1.6%), drain avulsion in 2 (1.6%), severe pain at the site of insertion in 2 (1.6%) patients. ","[{'ForeName': 'Kamil M', 'Initials': 'KM', 'LastName': 'Fram', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Shawqi', 'Initials': 'S', 'LastName': 'Saleh', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Fidaa', 'Initials': 'F', 'LastName': 'Thikerallah', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Farah K', 'Initials': 'FK', 'LastName': 'Fram', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Rand K', 'Initials': 'RK', 'LastName': 'Fram', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Darwish', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Othman', 'Affiliation': 'Department of Obstetrics and Gynecology, Jordan University Hospital, Amman, Jordan.'}]",Przeglad menopauzalny = Menopause review,['10.5114/pm.2020.95332'] 2043,32509113,Effect of Acute High-intensity Interval Exercise on Whole-body Fat Oxidation and Subcutaneous Adipose Tissue Cell Signaling in Overweight Women.,"Exercise-induced alterations in adipose tissue insulin and/or β-adrenergic signaling may contribute to increases in whole-body fat oxidation following acute exercise. Thus, we examined changes in insulin (Akt, AS160) and β-adrenergic (PKA) signaling proteins in subcutaneous adipose tissue and whole-body fat oxidation in overweight women following acute high-intensity interval exercise (HIIE). Overweight females completed two experimental sessions in a randomized order: 1) control (bed rest) and 2) HIIE (10 × 4 min running intervals at 90% HR max , 2-min recovery). Subcutaneous abdominal adipose tissue biopsies were obtained from 10 participants before (pre-), immediately (0hr) after (post-), 2hr post-, and 4hr post-exercise. Plasma glucose and insulin levels were assessed in venous blood samples obtained at each biopsy time-point from a different group of 5 participants (BMI-matched to biopsy group). Fat oxidation rates were estimated using the respiratory exchange ratio (RER) in all participants using indirect calorimetry pre-, 2hr post-, and 4hr post-exercise. RER was decreased ( p < 0.05) at 2hr post-exercise after HIIE (0.77 ± 0.04) compared to control (0.84 ± 0.04). Despite higher plasma glucose ( p < 0.01) and insulin ( p < 0.05) levels at 0hr post-exercise versus control, no significant interaction effects were observed for Akt or AS160 phosphorylation ( p > 0.05). Phosphorylation of PKA substrates was unaltered in both conditions ( p > 0.05). Collectively, altered β-adrenergic and insulin signaling in subcutaneous adnominal adipose tissue does not appear to explain increased whole-body fat oxidation following acute HIIE.",2020,"Despite higher plasma glucose ( p < 0.01) and insulin ( p < 0.05) levels at 0hr post-exercise versus control, no significant interaction effects were observed for Akt or AS160 phosphorylation ( p > 0.05).","['overweight women following acute high-intensity interval exercise (HIIE', 'Overweight Women', 'Overweight females']",['Acute High-intensity Interval Exercise'],"['insulin (Akt, AS160) and β-adrenergic (PKA) signaling proteins', 'Subcutaneous abdominal adipose tissue biopsies', 'RER', 'Fat oxidation rates', 'plasma glucose', 'Plasma glucose and insulin levels', 'Akt or AS160 phosphorylation', 'Phosphorylation of PKA substrates']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0010531', 'cui_str': 'Cyclic AMP-Dependent Protein Kinase'}]",,0.0331204,"Despite higher plasma glucose ( p < 0.01) and insulin ( p < 0.05) levels at 0hr post-exercise versus control, no significant interaction effects were observed for Akt or AS160 phosphorylation ( p > 0.05).","[{'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Islam', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}, {'ForeName': 'Marysa M W', 'Initials': 'MMW', 'LastName': 'Smith', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}, {'ForeName': 'Trisha D', 'Initials': 'TD', 'LastName': 'Scribbans', 'Affiliation': 'Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, MANITOBA, CANADA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McCrady', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Castellani', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ONTARIO, CANADA.'}, {'ForeName': 'Matti D', 'Initials': 'MD', 'LastName': 'Allen', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, ONTARIO, CANADA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Simpson', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Gurd', 'Affiliation': ""School of Kinesiology of Health Studies, Queen's University, Kingston, ONTARIO, CANADA.""}]",International journal of exercise science,[] 2044,32509115,The Effect of Beetroot Supplementation on High-Intensity Functional Training Performance.,"Nitrate supplementation (NO 3 - ) has been shown to improve athletic performance for short-duration, vigorous activity, as well as long-duration, aerobic activity. The purpose was to explore the effects of beetroot supplementation (BR) on high-intensity functional training (HIFT) performance. Twenty-four HIFT participants (25 ± 6.5 years, 175.17 ± 8.1 cm, 84.94 ± 12.09 kg), who attended HIFT classes at least 3 days per week for the past 3 months, performed a benchmark performance test (5 rounds of a 400-m run followed by 15 overhead squats with a 95-lb (for males)/65-lb (for females) barbell). In a randomized order, 72 hrs apart, participants were tested under a control session and once after consuming 70 mL beetroot nitrate supplement, Beet It ® , 2 hours prior to beginning the assigned benchmark test. For both benchmark tests, time to completion, pre- and post-exercise blood lactate levels, RPE, and pre-, during, and post-exercising heart rates were measured. There was no significant difference ( p < 0.05) between the control (930 ± 192.6 sec) and supplement (952.8 ± 205.8 sec) on time to complete the performance test. Post-exercise blood lactate (11.14 ± 2.84 mm/dL) was not significantly different ( p < 0.05) than the control (12.00 ± 2.53 mm/dL). Additionally, mean RPE for BR supplement (14.78 ± 2.50) was not significantly different ( p < 0.05) than the control (14.92 ± 2.12). The short duration and high intensity of the workout, which included both anaerobic and aerobic components, may have mitigated the cardiovascular effect of beetroot nitrates unlike previous research that found significant positive effects between beetroot nitrates and exercise performance.",2020,There was no significant difference ( p < 0.05) between the control (930 ± 192.6 sec) and supplement (952.8 ± 205.8 sec) on time to complete the performance test.,"['Twenty-four HIFT participants (25 ± 6.5 years, 175.17 ± 8.1 cm, 84.94 ± 12.09 kg), who attended HIFT classes at least 3 days per week for the past 3 months, performed a benchmark performance test (5 rounds of a 400-m run followed by 15 overhead squats with a 95-lb (for males)/65-lb (for females) barbell']","['beetroot supplementation (BR', 'Nitrate supplementation (NO 3 - ', 'Beetroot Supplementation']","['time to completion, pre- and post-exercise blood lactate levels, RPE, and pre-, during, and post-exercising heart rates', 'High-Intensity Functional Training Performance', 'high-intensity functional training (HIFT) performance', 'athletic performance', 'Post-exercise blood lactate']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",24.0,0.0910752,There was no significant difference ( p < 0.05) between the control (930 ± 192.6 sec) and supplement (952.8 ± 205.8 sec) on time to complete the performance test.,"[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Collins', 'Affiliation': 'Exercise Physiology Department, University of Lynchburg, Lynchburg, VA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kearns', 'Affiliation': 'Exercise Physiology Department, University of Lynchburg, Lynchburg, VA, USA.'}]",International journal of exercise science,[] 2045,32509116,Muscle Sentry® has No Effect on Total Work Performed and Estimated MVO 2 after High Intensity Short Duration Resistance Training.,"Supplements are widely used in recreational and professional participants; however, their claimed benefits are hardly to test. This study compared the total lifted numbers and post-exercise estimated MVO 2 while subjects were treated with either Muscle Sentry ® (MS) or placebo (PL), in a 7-day washout period. Participants (11 women, 10 men, 20-24 years) performed 3 sets to failure chest and leg press exercises at 8 RM with 2 min rest between sets. Each exercise was performed four times (2 × MS, 2 × PL) at the same time of the day separated by 48 h. The supplementation was ingested 40 min prior to perform the exercise. Prior to the exercise and immediately after each set, both HR and BP were obtained. The rate pressure product (RPP) was then calculated to determine estimated MVO 2 . Daily RPP and total weight lifted (chest + leg) for each supplementation were averaged. Normalized RPP was the ratio of averaged RPP and averaged total weight lifted. No treatment effect on chest, leg and total lift numbers, normalized post RPP (NPRPP), normalized RPP diff (NRPP diff ) (p=0.94, 0.86, 0.87, 0.87, 0.43 respectively); No treatment effect on total lift numbers, NPRPP, NRPP diff for gender (p=0.87, 0.95, 0.96 respectively). Ingestion of Muscle Sentry ® 40 min prior to do 3 sets to failure of both chest and leg presses had no effect upon either total lift numbers or estimated MVO 2 . This suggests that, in some instances, the benefits of Muscle Sentry ® are less than those claimed by the manufacturer.",2020,"No treatment effect on total lift numbers, NPRPP, NRPP diff for gender (p=0.87, 0.95, 0.96 respectively).","['Participants (11 women, 10 men, 20-24 years']",['Muscle Sentry ® (MS) or placebo (PL'],"['Normalized RPP', 'chest, leg and total lift numbers, normalized post RPP (NPRPP), normalized RPP diff (NRPP diff ', 'rate pressure product (RPP', 'Daily RPP and total weight lifted (chest + leg', 'total lift numbers, NPRPP, NRPP diff for gender']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",,0.0288,"No treatment effect on total lift numbers, NPRPP, NRPP diff for gender (p=0.87, 0.95, 0.96 respectively).","[{'ForeName': 'Junhai', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Farney', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA.'}, {'ForeName': 'Arnold G', 'Initials': 'AG', 'LastName': 'Nelson', 'Affiliation': 'School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA.'}]",International journal of exercise science,[] 2046,32509117,Acute Capsaicin Analog Supplementation Improves 400 M and 3000 M Running Time-Trial Performance.,"Objectives Performance in running-based sport depends on the ability to perform repetitive high intensity muscle contractions. Previous studies have shown that capsaicin analog (CAP) (i.e. Capsiate) supplementation may improve this performance. The purpose of this study was to investigate the acute effect of CAP supplementation on short (400 m) and middle distance (3000 m) running time-trial performance, maximum heart rate (HR), and rate of perceived exertion (RPE). Methods Twelve physically active men completed four randomized, double-blind trials: CAP condition (12 mg) or a placebo condition. Forty-five minutes after supplementation, the participants performed a 400- or 3000-meter running time trial. Time (in seconds) was recorded. HR was analyzed at rest and immediately post-exercise, and RPE was collected immediately after exercise. Results For both the 400 m time-trial (CAP = 66.4 + 4.2 sec vs Placebo = 67.1 + 4.8 sec, p = 0.046) and the 3000 m time-trial (CAP = 893.9 ± 46.8 sec vs Placebo = 915.2 ± 67.6 sec, p = 0.015), the time in seconds was significantly less in the CAP compared to placebo conditions. There were no statistically significant differences for HR and RPE in any condition. Conclusion In summary, acute CAP supplementation improved 400 m and 3000 m running time-trial performance in a distance-dependent way but without modifying the HR and RPE.",2020,"In summary, acute CAP supplementation improved 400 m and 3000 m running time-trial performance in a distance-dependent way but without modifying the HR and RPE.",['Methods\n\n\nTwelve physically active men'],"['placebo condition', 'Acute Capsaicin Analog Supplementation', 'CAP condition', 'capsaicin analog (CAP) (i.e. Capsiate) supplementation', 'CAP supplementation']","['HR and RPE', 'short (400 m) and middle distance (3000 m) running time-trial performance, maximum heart rate (HR), and rate of perceived exertion (RPE']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1173367', 'cui_str': 'capsiate'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}]",12.0,0.668504,"In summary, acute CAP supplementation improved 400 m and 3000 m running time-trial performance in a distance-dependent way but without modifying the HR and RPE.","[{'ForeName': 'Lásaro A', 'Initials': 'LA', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education, Federal University of Piauí (UFPI), Teresina, PI, BRAZIL.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Freitas', 'Affiliation': 'Department of Nutrition, University of Western São Paulo (UNOESTE), Presidente Prudente, SP, BRAZIL.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Cholewa', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Conway, SC, USA.'}, {'ForeName': 'Valéria L G', 'Initials': 'VLG', 'LastName': 'Panissa', 'Affiliation': 'Department of Sport, School of Physical Education and Sport, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Associate Graduate Program in Physical Education UPE/UFPB, João Pessoa, PB, BRAZIL.'}, {'ForeName': 'Vilton E L M', 'Initials': 'VELM', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Federal University of Piauí (UFPI), Teresina, PI, BRAZIL.'}, {'ForeName': 'Alcione M', 'Initials': 'AM', 'LastName': 'Sá', 'Affiliation': 'Department of Physical Education, Federal University of Piauí (UFPI), Teresina, PI, BRAZIL.'}, {'ForeName': 'Priscila A Q', 'Initials': 'PAQ', 'LastName': 'Rossi', 'Affiliation': 'Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, BRAZIL.'}, {'ForeName': 'Sergio L G', 'Initials': 'SLG', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Physical Education, Federal University of Piauí (UFPI), Teresina, PI, BRAZIL.'}, {'ForeName': 'Marcos A P', 'Initials': 'MAP', 'LastName': 'Santos', 'Affiliation': 'Department of Biophysics and Physiology, Federal University of Piaui, Campus Minister Petrônio Portela, Ininga, Teresina, PI, BRAZIL.'}, {'ForeName': 'Nelo E', 'Initials': 'NE', 'LastName': 'Zanchi', 'Affiliation': 'Department of Physical Education, Federal University of Maranhão, São Luís, BRAZIL.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, BRAZIL.'}, {'ForeName': 'Fabrício E', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Department of Physical Education, Federal University of Piauí (UFPI), Teresina, PI, BRAZIL.'}]",International journal of exercise science,[] 2047,32509120,"Acute Physiologic Effects of Performing Yoga in The Heat on Energy Expenditure, Range of Motion, and Inflammatory Biomarkers.","Performing yoga in a heated environment (HY) is a popular exercise mode purported to improve range of motion (ROM), body composition, and aerobic fitness. The purpose of this investigation was to compare a session of HY to room temperature yoga (RTY) with regards to ROM, oxygen consumption, caloric expenditure, and biomarkers of acute stress and inflammation. Sixteen experienced yoga practitioners (F14, M2; 40 ± 11yr; 22.6 ± 1.8 kg/m 2 ) completed a 1-hour standardized Bikram sequence in HY (105°F, 40°C) and RTY (74°F, 23.3°C) conditions (order of conditions randomized, humidity standardized at 40%). Intra-exercise metabolic gas exchange and heart rate (HR) was monitored using a metabolic cart. ROM measures were taken pre and post-exercise at the elbow, shoulder, hip, and knee. Cytokines interleukin 6,10 (IL-6, IL-10) and tumor-necrosis-factor alpha (TNF-α) were analyzed from blood samples collected pre- and 30-minutes post-exercise. Intra-exercise metabolic gas exchange and heart rate (HR) was monitored using a metabolic cart. Both bouts elicited similar acute changes in ROM although HY elicited a greater increase in hip abduction (RTYΔ° = 2.3 ± 1.3|HYΔ° = 6.6 ± 1.5; p < 0.05). Mean VO 2 , peak VO 2 , %VO 2 max, HR, and kcal expenditure did not differ between conditions. RER was lower during the HY (RTY = 0.95 ± 0.02| HY = 0.89 ± 0.02; p < 0.05) with a concomitant elevation in fat oxidation (RTY = 0.05 ± 0.01|HY = 0.09 ± 0.01, g·min -1 ; p < 0.05) and decrease in carbohydrate oxidation (RTY = 0.51 ± 0.04|HY = 0.44 ± 0.03, g·min -1 ; p < 0.05). Serum IL-6 was increased (15.5 ± 8.0-fold) following HY only ( p < 0.05). HY does not significantly elevate aerobic energy cost compared to RTY but may acutely increase fat substrate utilization and hip ROM. Future studies remain needed to establish dose-response relationships for including HY or RTY into well-rounded fitness programs.",2020,HY does not significantly elevate aerobic energy cost compared to RTY but may acutely increase fat substrate utilization and hip ROM.,"['Sixteen experienced yoga practitioners (F14, M2; 40 ± 11yr; 22.6 ± 1.8 kg/m 2 ) completed a']","['1-hour standardized Bikram sequence in HY', 'HY to room temperature yoga (RTY']","['fat substrate utilization and hip ROM', 'Energy Expenditure, Range of Motion, and Inflammatory Biomarkers', 'RER', 'aerobic energy cost', 'ROM measures', 'range of motion (ROM), body composition, and aerobic fitness', 'ROM, oxygen consumption, caloric expenditure, and biomarkers of acute stress and inflammation', 'Mean VO 2 , peak VO 2 , %VO 2 max, HR, and kcal expenditure', 'Cytokines interleukin 6,10 (IL-6, IL-10) and tumor-necrosis-factor alpha (TNF-α', 'hip abduction', 'Serum IL-6', 'carbohydrate oxidation', 'fat oxidation', 'Intra-exercise metabolic gas exchange and heart rate (HR']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",16.0,0.0751324,HY does not significantly elevate aerobic energy cost compared to RTY but may acutely increase fat substrate utilization and hip ROM.,"[{'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Lambert', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Domenica A', 'Initials': 'DA', 'LastName': 'Delgado', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Chaliki', 'Affiliation': 'Department of Kinesiology, Rice University, Houston, TX, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Rice University, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bauza', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Taraballi', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Ennio', 'Initials': 'E', 'LastName': 'Tasciotti', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'McCulloch', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Houston Methodist Hospital, Houston, TX, USA.'}]",International journal of exercise science,[] 2048,32509124,Comparison of Post-Activation Potentiating Stimuli on Jump and Sprint Performance.,"Post-activation potentiation (PAP) is a phenomenon characterized by improved muscle performance based on the previous contractile activity of the muscle. The purpose of this study was to determine the effect of different potentiating stimuli on jump and sprint performance in 13 resistance trained, college-aged men and women. After determining back squat 1 repetition max, subjects returned for testing on separate days to complete one of four interventions (dynamic resistance, weighted plyometric, isometric, or control) in a randomized order. A standardized warmup was performed, followed by a baseline countermovement jump (CMJ) and 20m sprint. Following warm-up and baseline measurements, subjects performed one of the four experimental conditions. CMJ and 20m sprint measurements were completed again at 20-seconds, 4, 8, 12, 16, and 20-minutes. Results revealed significantly faster 0-20m sprint times ( p < .05) at the 4, 8, 12, 16, and 20-minute time points compared to baseline and 20-second time points. Significantly faster 0-20m sprint times ( p < .05) were also shown for the squat intervention compared to control at 4-minutes, the plyometric and squat intervention compared to control at 8-minutes, the isometric intervention compared to control at 12 and 16-minutes, and the isometric intervention compared to the squat at 20-minutes. These findings indicate that while all PAP stimuli utilized can be effective at improving sprint performance, specific optimal time points may exist.",2020,"Significantly faster 0-20m sprint times ( p < .05) were also shown for the squat intervention compared to control at 4-minutes, the plyometric and squat intervention compared to control at 8-minutes, the isometric intervention compared to control at 12 and 16-minutes, and the isometric intervention compared to the squat at 20-minutes.","['13 resistance trained, college-aged men and women']",['Post-activation potentiation (PAP'],"['faster 0-20m sprint times', 'jump and sprint performance', 'Jump and Sprint Performance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",,0.0177431,"Significantly faster 0-20m sprint times ( p < .05) were also shown for the squat intervention compared to control at 4-minutes, the plyometric and squat intervention compared to control at 8-minutes, the isometric intervention compared to control at 12 and 16-minutes, and the isometric intervention compared to the squat at 20-minutes.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Piper', 'Affiliation': 'Michael Johnson Performance, McKinney, TX, USA.'}, {'ForeName': 'Dustin P', 'Initials': 'DP', 'LastName': 'Joubert', 'Affiliation': 'Department of Kinesiology and Health Science, Stephen F. Austin State University, Nacogdoches, TX, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Jones', 'Affiliation': 'Department of Kinesiology and Health Science, Stephen F. Austin State University, Nacogdoches, TX, USA.'}, {'ForeName': 'Malcolm T', 'Initials': 'MT', 'LastName': 'Whitehead', 'Affiliation': 'Department of Kinesiology and Health Science, Stephen F. Austin State University, Nacogdoches, TX, USA.'}]",International journal of exercise science,[] 2049,32509134,"Three Weeks of Detraining Does Not Decrease Muscle Thickness, Strength or Sport Performance in Adolescent Athletes.","The purpose of this study was to examine the effects of detraining following a block (BLOCK) or daily undulating periodized (DUP) resistance training (RT) on hypertrophy, strength, and athletic performance in adolescent athletes. Twenty-one males (age = 16 ± 0.7 years; range 15-18 years) were randomly assigned to one of two 12-week intervention groups (three full-body RT sessions per week): BLOCK ( n = 9); DUP ( n = 12). Subsequently a three-week detraining period was applied. Body mass, fat mass (FM), fat-free mass (FFM), muscle mass, muscle thickness (rectus femoris, vastus lateralis and triceps brachii), one-repetition maximum squat and bench press, countermovement jump (CMJ), peak power calculated from CMJ (Ppeak), medicine ball put distance, and 36.58m sprint were recorded before and after RT as well as after detraining. BLOCK and DUP were equally effective for improvements of athletic performance in young athletes. Both groups displayed significantly ( ρ ≤ 0.05) higher values of all measures after RT except FM, which was unchanged. Only FM increased ( p = 0.010; ES = 0.14) and FFM decreased ( p = 0.018; ES = -0.18) after detraining. All other measurements were unaffected by the complete cessation of training. Values were still elevated compared to pre-training. Linear regression showed a strong correlation between the percentage change by resistance training and the decrease during detraining for CMJ (R2 = 0.472) and MBP (R2 = 0.629). BLOCK and DUP RT seem to be equally effective in adolescent athletes for increasing strength, muscle mass, and sport performance. In addition, three weeks of detraining did not affect muscle thickness, strength, or sport performance in adolescent athletes independent of previous resistance training periodization model used.",2020,"Both groups displayed significantly ( ρ ≤ 0.05) higher values of all measures after RT except FM, which was unchanged.","['Adolescent Athletes', 'young athletes', 'adolescent athletes', 'Twenty-one males (age = 16 ± 0.7 years; range 15-18 years']",['detraining following a block (BLOCK) or daily undulating periodized (DUP) resistance training (RT'],"['FFM', 'Muscle Thickness, Strength or Sport Performance', 'athletic performance', 'muscle thickness, strength, or sport performance', 'Body mass, fat mass (FM), fat-free mass (FFM), muscle mass, muscle thickness (rectus femoris, vastus lateralis and triceps brachii), one-repetition maximum squat and bench press, countermovement jump (CMJ), peak power calculated from CMJ (Ppeak), medicine ball put distance, and 36.58m sprint', 'hypertrophy, strength, and athletic performance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",21.0,0.0132455,"Both groups displayed significantly ( ρ ≤ 0.05) higher values of all measures after RT except FM, which was unchanged.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gavanda', 'Affiliation': 'Institute of Fitness and Health, IST University of Applied Sciences, Düsseldorf, NORDRHEINWESTFALEN, GERMANY.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Geisler', 'Affiliation': 'Institute of Fitness and Health, IST University of Applied Sciences, Düsseldorf, NORDRHEINWESTFALEN, GERMANY.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Quitmann', 'Affiliation': 'Institute of Movement and Neurosciences, German Sport University Cologne, Cologne, NORDRHEIN-WESTFALEN, GERMANY.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bauhaus', 'Affiliation': 'Institute of Biochemistry, German Sport University Cologne, Cologne, NORDRHEIN-WESTFALEN, GERMANY.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schiffer', 'Affiliation': 'Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, Cologne, Nordrhein-Westfalen, Germany.'}]",International journal of exercise science,[] 2050,32509137,Step Count Reliability and Validity of Five Wearable Technology Devices While Walking and Jogging in both a Free Motion Setting and on a Treadmill.,"Wearable technology devices are used by millions of people who use daily step counts to promote healthy lifestyles. However, the accuracy of many of these devices has not been determined. The purpose was to determine reliability and validity of the Samsung Gear 2, FitBit Surge, Polar A360, Garmin Vivosmart HR+, and the Leaf Health Tracker when walking and jogging in free motion and treadmill conditions. Forty volunteers completed walking and jogging free motion and treadmill protocols of 5-minute intervals. The devices were worn simultaneously in randomized configurations. The mean of two manual steps counters was used as the criterion measure. Test-retest reliability was determined via Intraclass Correlation Coefficient (ICC). Validity was determined via a combination of Pearson's Correlation Coefficient, mean absolute percent error (MAPE: free motion ≤ 10.0%, treadmill ≤ 5.00%), and Bland-Altman analysis (device bias and limits of agreement). Significance was set at p < 0.05. The Samsung Gear 2 was deemed to be both reliable and valid for the jogging conditions, but not walking. The Fitbit Surge was reliable and valid for all conditions except for treadmill walking (deemed reliable, ICC = 0.76; but not valid). The Polar A360 was found to be reliable for one condition (treadmill jog ICC = 0.78), but not valid for any condition. The Garmin Vivosmart HR+ and Leaf Health Tracker were found to be both reliable and valid for all situations. While each device returned some level of consistency and accuracy during either free motion or treadmill exercises, the Garmin Vivosmart HR+ and the Leaf Health Tracker were deemed to be reliable and valid for all conditions tested.",2020,The Garmin Vivosmart HR+ and Leaf Health Tracker were found to be both reliable and valid for all situations.,['Forty volunteers completed'],"['walking and jogging free motion and treadmill protocols of 5-minute intervals', 'Five Wearable Technology Devices']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],40.0,0.0252858,The Garmin Vivosmart HR+ and Leaf Health Tracker were found to be both reliable and valid for all situations.,"[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Montes', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tandy', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Szu-Ping', 'Initials': 'SP', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}]",International journal of exercise science,[] 2051,32509241,Helicobacter pylori eradication in the management of glaucoma.,"Background To investigate the possibility that the eradication of H pylori infection is associated with a reduction in the risk of glaucoma. Methods Sixty-five successive patients with elevated intraocular pressure (IOP) or glaucoma were included in the study. Serum samples from all subjects were analyzed for the presence of H pylori - antibodies using ELISA. Forty patients with positive serologic test were included. Half of the patients enrolled into intervention group and the other half registered as control. Intervention arm was referred to the Gastroenterology Clinic for eradication of H pylori and evaluated for the effect of H pylori regimen eradication on IOP and glaucoma over 2 months of follow-up. The age-matched controls did not receive treatment. Urea breath test was applied to confirm eradication. Results There was a significant (p=0.005) reduction in IOP after complete eradication in the intervention group. This value was not significant in control patients (p=0.08). The mean IOP before treatment of glaucoma in the control group was 23.60±2.37 mmHg and after treatment with anti-glaucoma drugs was 14.25±1.48 mmHg on the onset of study, and 13.55±2.01 mmHg after follow up. The mean IOP before treatment of glaucoma in the intervention group was 24.55±3.6 mmHg and after treatment with anti-glaucoma drugs was 15.15±1.8 mmHg, and 14.3±1.6 mmHg after the eradication of H pylori with a drug regimen. However, after the treatment of glaucoma in all patients, the overall comparison of mean IOP differences showed no statistical difference (P=0.65). Conclusion H pylori eradication therapy may have a positive effect on the management of glaucoma.",2020,There was a significant (p=0.005) reduction in IOP after complete eradication in the intervention group.,"['Forty patients with positive serologic test were included', 'Methods\n\n\nSixty-five successive patients with elevated intraocular pressure (IOP) or glaucoma were included in the study']",[],"['IOP and glaucoma', 'Helicobacter pylori eradication', 'IOP', 'mean IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0270756,There was a significant (p=0.005) reduction in IOP after complete eradication in the intervention group.,"[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Iradj', 'Initials': 'I', 'LastName': 'Maleki', 'Affiliation': 'Department of Internal Medicine, Imam Khomeini Hospital, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sanjari Araghi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Sahebnasagh', 'Affiliation': 'Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Shahraki', 'Affiliation': 'Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Caspian journal of internal medicine,['10.22088/cjim.11.2.143'] 2052,32509244,Comparison of two manual therapy techniques in patients with carpal tunnel syndrome: A randomized clinical trial.,"Background Manual therapy techniques are part of physiotherapy treatment of carpal tunnel syndrome (CTS) which are classified into two groups including nerve mobilization and mechanical interface mobilization. The aim of the study was to find which manual therapy method-technique directed to mechanical interface and nerve mobilization-has superior beneficial effects on clinical and electrophysiological findings in conservative management of patients with CTS. Methods Thirty patients with CTS participated into two groups namely: mechanical interface and nerve mobilization in this randomized clinical trial. The intervention was performed three times weekly for 4 weeks. Mechanical interface mobilization was directed to structures around the median nerve at the forearm and wrist. Techniques of median nerve gliding and tension were used in the nerve mobilization group. The outcome measures included visual analogue scale (VAS), symptom severity scale (SSS), hand functional status scale (FSS) and motor and sensory distal latencies of median nerve. Paired t-test and ANCOVA were used for statistical analysis. Results At the end of the 4 th week of the treatment, the mean of VAS, SSS and FSS significantly improved in both groups (p<0.05), but the difference was not significant between the two groups (P>0.05). Although the mean of motor and sensory distal latencies of median nerve at the end of the treatment period only improved in the nerve mobilization group (p<0.05), the difference was not significant between the two groups (P>0.05). Conclusion Mechanical interface mobilization and nerve mobilization techniques are not superior to each other in reducing pain and improving hand symptoms and functional status.",2020,"At the end of the 4 th week of the treatment, the mean of VAS, SSS and FSS significantly improved in both groups (p<0.05), but the difference was not significant between the two groups (P>0.05).","['Thirty patients with CTS participated into two groups namely', 'patients with CTS', 'patients with carpal tunnel syndrome', 'carpal tunnel syndrome (CTS']",['mechanical interface and nerve mobilization'],"['mean of motor and sensory distal latencies of median nerve', 'visual analogue scale (VAS), symptom severity scale (SSS), hand functional status scale (FSS) and motor and sensory distal latencies of median nerve', 'mean of VAS, SSS and FSS']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",30.0,0.0256565,"At the end of the 4 th week of the treatment, the mean of VAS, SSS and FSS significantly improved in both groups (p<0.05), but the difference was not significant between the two groups (P>0.05).","[{'ForeName': 'Ghadam Ali', 'Initials': 'GA', 'LastName': 'Talebi', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Saadat', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Javadian', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Taghipour', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Caspian journal of internal medicine,['10.22088/cjim.11.2.163'] 2053,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002'] 2054,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. METHODS Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity. RESULTS 763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. CONCLUSION This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027'] 2055,32502940,"The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial.","BACKGROUND Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET) can reduce pre-operative tumour burden in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer. This prospective translational study assessed the ability of a 12-gene molecular score (MS; EndoPredict®) to predict response to NaCT or NET within the ABCSG-34 trial. PATIENTS AND METHODS Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase II trial were selected and EndoPredict testing was performed to generate a 12-gene MS. ABCSG-34 patients were assigned to receive either NaCT or NET based on menopausal status, HR expression, grade and Ki67. Response was measured by residual cancer burden (RCB). RESULTS Patients selected for NaCT generally had high-risk disease by 12-gene MS (125/134), while slightly more patients treated with NET had low-risk disease (44/83). Low-risk NaCT-treated and high-risk NET-treated tumours responded poorly (NPV 100% [95% CI 66.4%-100%] and NPV 92.3% [95% CI 79.1%-98.4%], respectively]. The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]). CONCLUSIONS The 12-gene MS predicted RCB after treatment with neoadjuvant therapies for patients with HR-positive, HER2-negative early-stage breast cancer. Tumours with low MS were unlikely to benefit from NaCT, whereas a high MS predicted resistance to NET. This additional biologic information can aid personalized treatment selection in daily practice and builds a strong rationale to use EndoPredict in biomarker-driven studies in the neoadjuvant setting.",2020,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]). ","['patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer', 'Hormone receptor (HR)-positive, HER2-negative samples from patients in the ABCSG-34 randomized phase', 'patients with HR-positive, HER2-negative early-stage breast cancer']","['neoadjuvant chemotherapy and neoendocrine therapy', 'NaCT', 'Neoadjuvant chemotherapy (NaCT) and neoadjuvant endocrine therapy (NET', 'NaCT or NET']","['residual cancer burden (RCB', 'high-risk disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0845297,"The 12-gene MS significantly predicted treatment response for NaCT (AUC 0.736 [95% CI 0.63-0.84]) and NET (AUC 0.726 [95% CI 0.60-0.85]). ","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Dubsky', 'Affiliation': 'Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breast Center St. Anna, Lucerne, Switzerland. Electronic address: peter.dubsky@hirslanden.ch.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Egle', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Wette', 'Affiliation': 'Breast Center, Brustzentrum Kärnten, St. Veit, Austria.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Pichler', 'Affiliation': 'Department of Hemato-Oncology, LKH Hochsteiermark-Leoben, Leoben, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular Cancer Research, Paracelsus Medical University, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Petzer', 'Affiliation': 'Internal Medicine I, Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinkum Linz Barmherzige Schwestern, Elisabethinen, Linz, Austria.'}, {'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fesl', 'Affiliation': 'Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Meek', 'Affiliation': 'Myriad Genetics, Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Kronenwett', 'Affiliation': 'Myriad International GmbH, Cologne, Germany.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.020'] 2056,32503608,"Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial.","INTRODUCTION Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%. METHODS This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment. DISCUSSION Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.",2020,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","['Chronic hepatitis B (CHB', 'hepatitis B cirrhosis', '802 patients', 'chronic hepatitis B']","['YQSH combined with entecavir', 'Antiviral therapy', 'YinQiSanHuang-antiviral decoction (YQSH', 'entecavir', 'YQSH', 'placebo with entecavir', 'traditional Chinese medicine (TCM', 'YinQiSanHuang-antiviral decoction with entecavir', 'YinQiSanHuang-antiviral decoction', 'placebo']","['efficacy and safety', ""hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment"", 'annual incidence of cirrhosis', 'Efficacy and safety']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0919711', 'cui_str': 'Hepatitis B surface antigen negative'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]",5.0,0.721903,"The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment.","[{'ForeName': 'Qing-Juan', 'Initials': 'QJ', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Liang', 'Initials': 'WL', 'LastName': 'Lv', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China. wenlianglv@126.com.""}, {'ForeName': 'Juan-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Zhou', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiu-Chong', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Ruo-Xuan', 'Initials': 'RX', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Si-Tong', 'Initials': 'ST', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Gao-Hui', 'Initials': 'GH', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zheng-Min', 'Initials': 'ZM', 'LastName': 'Cao', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.""}]",Trials,['10.1186/s13063-020-04395-y'] 2057,32503611,Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project.,"BACKGROUND After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment of a secure attachment between the children and their primary caregivers. Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being. In order to prevent a transgenerational transmission of mental disorders, it is necessary to evaluate psychotherapeutic interventions that target psychologically burdened parents of infants or toddlers. The aim of this trial is to investigate the efficacy of Parent-Infant-Psychotherapy (PIP) for mothers with postpartum mental disorder and their infants (0-12 months). METHODS/DESIGN In this open, randomized controlled intervention trial 180 mother-infant-dyads will be included and randomly allocated to 12 sessions of PIP or care as usual. The interventions take place either in inpatient adult psychiatric departments or in outpatient settings with home visits. The primary outcome is the change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions after 6 weeks. Secondary outcomes are maternal psychopathology, stress, parental reflective functioning, infant development and attachment after 6 weeks and 12 months. In addition, maternal attachment (AAI) and reflective functioning (AAI) will be analyzed as potential moderators, and resource usage in the German health system as well as associated costs will be evaluated. DISCUSSION There is increasing demand for well-controlled studies on psychotherapeutic interventions in the postpartum period that do not only focus on particular risk groups. This randomized controlled trial (RCT) represents one of the first studies to investigate the efficacy of PIP in inpatient psychiatric departments and outpatient care centers in Germany. The results will fill knowledge gaps on the factors contributing to symptom reduction in postpartum mental disorders and improvements in mother-child relationships and help in developing preventive and therapeutic strategies for the fragmented German health care system. TRIAL REGISTRATION German Register for Clinical Trials, ID: DRKS00016353.",2020,Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being.,"['inpatient psychiatric departments and outpatient care centers in Germany', 'psychologically burdened parents of infants or toddlers', 'mothers with postpartum mental disorder', 'inpatient adult psychiatric departments or in outpatient settings with home visits', '180 mother-infant-dyads', 'mothers with postpartum mental disorder and their infants (0-12\u2009months']","['Parent-Infant-Psychotherapy (PIP', 'Parent-Infant-Psychotherapy', 'PIP']","['Efficacy', 'maternal attachment (AAI) and reflective functioning (AAI', 'maternal psychopathology, stress, parental reflective functioning, infant development and attachment', 'change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3839606', 'cui_str': 'Parent-infant psychotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.12825,Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mattheß', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany. janna.matthess@ipu-berlin.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eckert', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Koch', 'Affiliation': 'International Psychoanalytic University, Stromstr. 3b, 10555, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reinhold', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vienhues', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berghöfer', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Keil', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schlensog-Schuster', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'von Klitzing', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ludwig-Körner', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kuchinke', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Diakonissenkrankenhaus Flensburg, Flensburg, Germany.'}]",Trials,['10.1186/s13063-020-04443-7'] 2058,32503620,Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial.,"OBJECTIVES Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reducing Intereukin-6, Interleukin-8, Tumour Necrosis Factor-alpha besides controlling oxidative stress pathways which all are important and pathologic components in the clinical course and outcome of patients infected with COVID-19. This study aims to assess the anti-inflammatory effects of colchicine in non-severe hospitalized COVID-19 patients. TRIAL DESIGN Prospective, randomized (1:1 ratio), double blind study with parallel group design. PARTICIPANTS Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia. The patients are not severely hypoxic, do not need intubation or invasive oxygenation. EXCLUSION CRITERIA known hypersensitivity to colchicine; known hepatic failure; estimated glomerular filtration rate (eGFR)<30 ml/min/1.73m 2 (by the CKD-EPI Creatinine Equation for Glomerular Filtration Rate (GFR) which estimates GFR based on serum creatinine. ; kidney transplant recipients, using Digoxin, QTc >450 msec. Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran. INTERVENTION AND COMPARATOR Eligible enrolled patients will be randomized into two groups. Group A will receive the antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine 1.5 mg loading then 0.5 mg twice daily orally. All patients in both groups will receive the same amounts of essential minerals, vitamins as antioxidants, and antibiotics. Patients of both groups will be treated under optimal treatment based on the CDC and WHO guidelines and national consensus proposed in Iran including the same dosages of Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine will be added on top of this protocol. MAIN OUTCOMES Primary: Time for clinical improvement and lung CT score changes 14 days after treatment. Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels reduction - Percentage of patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION: Patients will be allocated to each group (ratio 1:1) by using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm BLINDING (MASKING): This will be a double-blind study in which participants and those assessing the final outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Regarding the pandemic crisis and our center capacity to hospitalize confirmed COVID-19 patients, a total of 80 patients was found to be logical to be randomized into two groups of 40- patients. TRIAL STATUS Recruitment is ongoing. Recruitment began on 20/03/2020 and the date by which the recruitment is anticipated to be completed is 30/05/2020. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04360980, registered 24/04/2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[' kidney transplant recipients, using Digoxin, QTc >450 msec', 'Hospitalized Patients with Non-Severe Covid-19 Pneumonia', 'Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia', '80 patients was found to be logical to be randomized into two groups of 40- patients', 'non-severe hospitalized COVID-19 patients', 'Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran', 'patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION']","['Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra', 'Colchicine', 'essential minerals, vitamins as antioxidants, and antibiotics', 'colchicine', 'Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine', 'antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine']","['glomerular filtration rate', 'Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels', 'clinical improvement and lung CT score changes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0202202', 'cui_str': 'Protein measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.454787,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[{'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Dalili', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran. drn.dalili@sbmu.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kashefizadeh', 'Affiliation': 'Department of Pulmonology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nafar', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Poorrezagholi', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Firouzan', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Samadian', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Samavat', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ziaie', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Fatemizadeh', 'Affiliation': 'Department of Internal Medicine, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04455-3'] 2059,32503649,The effects of mindfulness-based cognitive therapy on risk and protective factors of depressive relapse - a randomized wait-list controlled trial.,"BACKGROUND The aim of this randomized wait-list controlled trial was to explore the effects of Mindfulness-Based Cognitive Therapy (MBCT) on risk and protective factors for depressive relapse within the domains of cognition, emotion and self-relatedness. METHODS Sixty-eight individuals with recurrent depressive disorder were randomized to MBCT or a wait-list control condition (WLC). RESULTS Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018). In the Intention To Treat sample, findings were attenuated, but there were still significant results on measures of rumination, self-compassion and depression. CONCLUSIONS Findings from the present trial contribute to evidence that MBCT can lead to reduction in risk factors of depressive relapse, and strengthening of factors known to be protective of depressive relapse. The largest changes were found in the domain of self-relatedness, in the form of large effects on the participants' ability to be less self-judgmental and more self-compassionate. TRIAL REGISTRATION ISRCTN, ISRCTN18001392. Registered 29 June 2018.",2020,"RESULTS Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018).",['Sixty-eight individuals with recurrent depressive disorder'],"['MBCT', 'Mindfulness-Based Cognitive Therapy (MBCT', 'MBCT or a wait-list control\xa0condition (WLC', 'mindfulness-based cognitive therapy']","['emotion regulation', 'measures of rumination', 'rumination, self-compassion and depression', 'emotional reactivity to stress', 'measures assessing risk and protective factors of recurrent depression', 'self-compassion', 'depression']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0349218', 'cui_str': 'Recurrent depressive disorder, unspecified'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}]",68.0,0.0637137,"RESULTS Completers of MBCT (N = 26) improved significantly on measures assessing risk and protective factors of recurrent depression compared to WLC (N = 30) on measures of rumination (d = 0.59, p = .015), emotion regulation (d = 0.50, p = .028), emotional reactivity to stress (d = 0.32, p = .048), self-compassion (d = 1.02, p < .001), mindfulness (d = 0.59, p = .010), and depression (d = 0.40, p = .018).","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schanche', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway. elisabeth.schanche@uib.no.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Vøllestad', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Endre', 'Initials': 'E', 'LastName': 'Visted', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Julie Lillebostad', 'Initials': 'JL', 'LastName': 'Svendsen', 'Affiliation': 'Kronstad District Psychiatric Centre (DPS), Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Berge', 'Initials': 'B', 'LastName': 'Osnes', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Per Einar', 'Initials': 'PE', 'LastName': 'Binder', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Franer', 'Affiliation': 'Kronstad District Psychiatric Centre (DPS), Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Sørensen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",BMC psychology,['10.1186/s40359-020-00417-1'] 2060,32504574,"Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.","BACKGROUND In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies. METHODS We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov, NCT02607930 and NCT02607956. FINDINGS 629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide). At week 144, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference -2·6%, 95% CI -8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (difference -1·9%, -7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (-0·1 vs -0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study. INTERPRETATION These long-term data support the use of bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance. FUNDING Gilead Sciences.",2020,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","['people with HIV, with no emergent resistance', 'HLA-B*5701-negative adults without hepatitis B virus co-infection', '629 participants were randomly assigned and treated in study 1 (314 to']","['alafenamide', 'coformulated bictegravir, emtricitabine, and tenofovir alafenamide', 'direct LDL', 'bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide', 'tenofovir alafenamide', 'bictegravir, emtricitabine, and tenofovir', 'bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg', 'Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens', 'bictegravir, emtricitabine, and tenofovir alafenamide', 'coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine', 'lamivudine', 'bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine']","['fasting total cholesterol', 'plasma HIV-1 RNA less', 'total cholesterol to HDL ratio', 'Weight gain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0440557', 'cui_str': 'B*5701'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",629.0,0.25769,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK; Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario La Paz, IdiPaz Madrid, Spain.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Martorell', 'Affiliation': 'The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Hans-Jurgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Unit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Infectious Disease Department, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Flamm', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente Medical Group, Sacramento, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Elton John Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30099-0'] 2061,32504575,"Population uptake of HIV testing, treatment, viral suppression, and male circumcision following a community-based intervention in Botswana (Ya Tsie/BCPP): a cluster-randomised trial.","BACKGROUND In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana. METHODS The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov (NCT01965470). FINDINGS In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02-1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029). INTERPRETATION It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas. FUNDING US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.",2020,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029). ","['In the same communities, 10\u2008791 (86%) of 12\u2008489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities', 'residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates', '15 communities', 'people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised', '30 communities across Botswana done from Oct 30, 2013, to June 30, 2018', 'six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015', '1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities']","['community-based intervention in Botswana (Ya Tsie/BCPP', 'HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care']","['Population levels of ART, viral suppression, and male circumcision']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]",15.0,0.247072,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029). ","[{'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA. Electronic address: kathleen.wirth@gmail.com.'}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Pretorius Holme', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mompati', 'Initials': 'M', 'LastName': 'Mmalane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Kadima', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Unoda', 'Initials': 'U', 'LastName': 'Chakalisa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlo', 'Initials': 'K', 'LastName': 'Manyake', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Atang', 'Initials': 'A', 'LastName': 'Matildah Mbikiwa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Selebaleng V', 'Initials': 'SV', 'LastName': 'Simon', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Letlhogile', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlwano', 'Initials': 'K', 'LastName': 'Mukokomani', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Widenfelt', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Sikhulile', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting, Ballston Lake, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leidner', 'Affiliation': 'Goodtables Data Consulting, Norman, Oklahoma, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Powis', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Alwano', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Dryden-Peterson', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Coulson', 'Initials': 'C', 'LastName': 'Kgathi', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Raizes', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA; Intellectual Concepts, Atlanta, GA, USA.'}, {'ForeName': 'Baraedi', 'Initials': 'B', 'LastName': 'Sento', 'Affiliation': 'Tebelopele Voluntary Counseling and Testing Center, Gaborone, Botswana.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Novitsky', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Shenaaz', 'Initials': 'S', 'LastName': 'El-Halabi', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Sexton', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Pals', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Shapiro', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Tchetgen Tchetgen', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Statistics, The Wharton School at the University of Pennsylvania, Philadelphia, PA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30103-X'] 2062,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995'] 2063,32506498,Negative-pressure wound therapy does not reduce superficial SSI in pancreatectomy and hepatectomy procedures.,"INTRODUCTION Surgical site infections (SSIs) lead to increased morbidity and cost. Negative-pressure wound therapy (NPWT) removes wound exudate and improves local blood flow, but its effect on SSI is unproven following hepatectomy and pancreatectomy. The aim of this trial was to evaluate the effect of NPWT on SSI in this population. METHODS Patients were randomized to incisional NPWT or sterile island dressing following surgery. SSI predictive factors were recorded as well as patient comorbidities. Wound complications and type of SSI were recorded prospectively. RESULTS Forty patients received the standardized perioperative bundle. Twenty patients received sterile island: 11 hepatic and 9 pancreatic resections; 20 patients received NPWT: 11 hepatic and 9 pancreatic resections; 23 patients were male; mean age 60.8 years (SD ±10.3); mean BMI 31.7 (SD ±7.0). There were three incisional wound infections: two with sterile island, one with NPWT; six organ space infections: four sterile island and two NPWT. There were no significant differences in SSI rates between groups (P = .57). CONCLUSION NPWT does not improve SSI rates over simple sterile dressing following hepatectomy or pancreatectomy. Improvements in SSI must be directed toward organ-space infections, which are unaffected by NPWT.",2020,"There were no significant differences in SSI rates between groups (P = .57). ","['Twenty patients received sterile island: 11 hepatic and 9 pancreatic resections; 20 patients received NPWT: 11 hepatic and 9 pancreatic resections; 23 patients were male; mean age 60.8 years (SD ±10.3); mean BMI 31.7 (SD ±7.0', 'Forty patients received the standardized perioperative bundle', 'Patients']","['Negative-pressure wound therapy', 'NPWT', 'Negative-pressure wound therapy (NPWT', 'incisional NPWT or sterile island dressing following surgery']","['incisional wound infections', 'SSI rates', 'superficial SSI', 'Wound complications and type of SSI', 'local blood flow', 'SSI predictive factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4708784', 'cui_str': '31.7'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",23.0,0.083828,"There were no significant differences in SSI rates between groups (P = .57). ","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': ""O'Neill"", 'Affiliation': 'Hiram Polk Jr. MD, Department of Surgery, Division of Surgical Oncology, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Robert C G', 'Initials': 'RCG', 'LastName': 'Martin', 'Affiliation': 'Hiram Polk Jr. MD, Department of Surgery, Division of Surgical Oncology, University of Louisville, Louisville, Kentucky.'}]",Journal of surgical oncology,['10.1002/jso.25980'] 2064,32506504,Zero-fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography: A single-center experience.,"BACKGROUND Right atrial electroanatomical mapping may be combined with SoundStar 3D diagnostic ultrasound catheter (EAM-ICE) as a zero-fluoroscopy procedure for radiofrequency catheter ablation (RFCA). We aimed to evaluate the efficiency and safety of zero-fluoroscopy transseptal puncture guided by EAM-ICE and fluoroscopy combined with intracardiac echocardiography (F-ICE) in patients with paroxysmal atrial fibrillation (PAF). HYPOTHESIS Zero-fluoroscopy transseptal puncture is an effective and safe procedure. METHODS This study had a prospective design. A total of 57 patients with PAF were enrolled and assigned to two groups. Twenty-seven patients were enrolled in the EAM-ICE group, and 30 patients were enrolled in the F-ICE group. RESULTS There were no statistically significant differences in baseline patient characteristics between groups. Transseptal puncture was successful in all patients (57/57, 100%). Total procedure time and duration of transseptal puncture were lower in the F-ICE group (199.4 ± 26.0 minutes vs 150.7 ± 22.1 minutes, P = 0.000; 118.4 ± 19.7 vs 70.5 ± 13.5 minutes, P = 0.000). There was no use of fluoroscopy in the EAM-ICE group (0 mGy vs 70.5 ± 13.5 mGy); the duration of fluoroscopy in the EAM-ICE group was negligible (0 minutes vs 5.4 ± 1.9 minutes). No procedural complication occurred in either group. CONCLUSIONS EAM-ICE guided zero-fluoroscopy transseptal puncture is an effective and safe procedure.",2020,"No procedural complication occurred in either group. ","['57 patients with PAF', 'patients with paroxysmal atrial fibrillation (PAF', 'Twenty-seven patients were enrolled in the EAM-ICE group, and 30 patients were enrolled in the F-ICE group']","['zero-fluoroscopy transseptal puncture guided by EAM-ICE and fluoroscopy combined with intracardiac echocardiography (F-ICE', 'SoundStar 3D diagnostic ultrasound catheter (EAM-ICE', 'fluoroscopy transseptal puncture', 'EAM-ICE guided zero-fluoroscopy transseptal puncture', 'Zero-fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography', 'Transseptal puncture']","['efficiency and safety', 'Total procedure time and duration of transseptal puncture', 'procedural complication', 'duration of fluoroscopy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1719788', 'cui_str': 'Episodic ataxia type 1'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729936', 'cui_str': 'Cardiac chamber structure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1719788', 'cui_str': 'Episodic ataxia type 1'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729936', 'cui_str': 'Cardiac chamber structure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",57.0,0.0322906,"No procedural complication occurred in either group. ","[{'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Junmeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruiqing', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': ""Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Hang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xinlu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zefeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}]",Clinical cardiology,['10.1002/clc.23401'] 2065,32506513,Use of Metabolic Syndrome Severity to Assess Treatment with Vitamin-E and Pioglitazone for Non-alcoholic Steatohepatitis.,"BACKGROUND AND AIM Non-alcoholic steatohepatits (NASH), which can lead to liver failure, requires liver biopsies to follow and is difficult to treat. Our goal was to assess metabolic syndrome (MetS) severity as a predictor of treatment success and a marker of response. METHODS We assessed data from the Pioglitazone, Vitamin-E or Placebo NASH Study (PIVENS), in which individuals with biopsy-confirmed NASH were randomized to receive pioglitazone, vitamin-E or placebo for 96 weeks. We assessed associations of a sex- and race/ethnicity-specific MetS-severity Z-score (MetS-Z) at baseline and 48 weeks with biopsy-determined endpoint of NASH resolution at 96 weeks. RESULTS Baseline MetS-Z was inversely associated with odds of NASH resolution (odds ratio [OR] per 1-SD of MetS-Z-score: 0.47, 95% confidence interval [CI] 0.28,0.79). Decrease in MetS-Z during initial 48-week intervention was greatest for pioglitazone treatment (effect-size: -0.31, CI -0.15,-0.48) and for vitamin-E tended toward being greater for those with vs. without NASH resolution (-0.18 vs. -0.05). Overall, 48-week change in MetS-Z was associated with NASH resolution (OR of per 1-SD change: 0.53, CI 0.33,0.85), though this was attenuated in models that included transaminases, which remained linked to treatment success (OR by change-in-AST Z-score: 0.38, CI 0.19,0.76). CONCLUSIONS Individuals with more severe metabolic derangement at baseline were less likely to exhibit NASH resolution, suggesting that individuals may have a threshold of MetS-severity beyond which successful treatment is unlikely. As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.",2020,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","['Non-alcoholic Steatohepatitis', 'individuals with biopsy-confirmed NASH']","['pioglitazone', 'Vitamin-E and Pioglitazone', 'pioglitazone, vitamin-E or placebo', 'Pioglitazone, Vitamin-E or Placebo NASH Study (PIVENS']","['NASH resolution', 'MetS-Z', 'metabolic syndrome (MetS) severity']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.680429,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, United States.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Mack', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, United States.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, United States.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology, PO Box 800386, University of Virginia, Charlottesville, Virginia, United States.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15131'] 2066,32506539,Neurodevelopmental outcomes of a randomised trial of intact cord resuscitation.,"AIM It has been suggested that intact cord resuscitation can reduce the risk of brain damage. We investigated the effects on neurodevelopment at two years of age. METHODS This study was performed in Kathmandu, Nepal. In 2016, 231 late preterm and term infants born vaginally and not breathing were randomised to resuscitation with an intact cord or the standard practice of early cord clamping (CC). At two years of age, the World Health Organization's Infant and Young Child Development tool was used to assess the child's neurodevelopment, during telephone interviews with caregivers. RESULTS We followed up 138 infants (59.7%) at a mean age of 24.8 ±0.8 months. A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC. The median (range) scores were 1.0 (0.1-2.1) versus. 0.9 (-2.0-1.8), respectively (p=0.04). There were no difference in the motor, language-cognitive and socio-emotional domains. CONCLUSION Neurodevelopment improvements were observed at two years of age in infants resuscitated with an intact rather than early clamped umbilical cord. No definitive conclusions could be drawn due to protocol violations and a low follow-up rate. More research is needed.",2020,"A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC.","['138 infants (59.7%) at a mean age of 24.8 ±0.8 months', 'In 2016, 231 late preterm and term infants born vaginally and not breathing']","['intact cord resuscitation', 'resuscitation with an intact cord or the standard practice of early cord clamping (CC']","['median (range) scores', 'motor, language-cognitive and socio-emotional domains']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.119022,"A significant difference was seen in the development for age Z-score, between the group resuscitated with an intact umbilical cord and the group resuscitated with early CC.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Isacson', 'Affiliation': 'Department of Clinical Sciences, Pediatrics/Neonatology, Lund University, Lund, Sweden.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Gurung', 'Affiliation': 'Golden community, Kathmandu, Nepal.'}, {'ForeName': 'Omkar', 'Initials': 'O', 'LastName': 'Basnet', 'Affiliation': 'Golden community, Kathmandu, Nepal.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences, Pediatrics/Neonatology, Lund University, Lund, Sweden.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kc', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15401'] 2067,32509712,"Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12-32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.","Objective: We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. Design: Randomized, double-blind, placebo-controlled trial. Setting and subjects: Children aged 12-32 months in Japan. Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom. Results: One hundred nine participants were randomized. Eight participants were lost to follow-up, withdrew consent, or were deemed inappropriate for the trial, with 101 participants receiving complete analyses (placebo group, n = 48; LF group, n = 53). Outcomes: The prevalence of acute gastrointestinal symptoms was significantly less in the LF group (22/53 [41.5%]) than in the placebo group (30/48 [62.5%], p = 0.046). The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030). Harms: The rate of adverse events was similar between the groups. No adverse drug reactions were found. Conclusions: LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12-32 months.",2020,"The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030). ","['children', 'Setting and subjects: Children aged 12-32 months in Japan', 'children aged 12-32 months', 'Results: One hundred nine participants were randomized', 'Children Aged 12-32 Months', 'Eight participants were lost to follow-up, withdrew consent, or were deemed inappropriate for the trial, with 101 participants receiving complete analyses (placebo group, n = 48; LF group, n = 53']","['lactoferrin (LF)-fortified formula', 'Placebo', 'placebo or LF', 'Lactoferrin-Fortified Formula', 'placebo']","['LF intake', 'rate of adverse events', 'acute gastrointestinal and respiratory symptoms', 'Prevalence of acute gastrointestinal and respiratory symptom', 'acute gastrointestinal symptoms', 'total number of days having acute respiratory symptoms', 'adverse drug reactions', 'prevalence of acute gastrointestinal symptoms', 'Acute Gastrointestinal Symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",109.0,0.760503,"The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030). ","[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Motoki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mizuki', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Teruomi', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Miyakawa', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Shutaro', 'Initials': 'S', 'LastName': 'Kubo', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamauchi', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Food Ingredients and Technology Institute, R&D Division, Morinaga Milk Industry, Co., Ltd., Zama, Kanagawa, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Preventive Medicine and Public Health, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00233'] 2068,32509796,Effects of a Low-Dose Spirulina/Turmeric Supplement on Cardiometabolic and Antioxidant Serum Markers of Patients With Abdominal Obesity.,"Obesity is one of the greatest public health problems worldwide. It is associated with underlying low-grade inflammation, thus is a risk factor for the development of cardiometabolic alterations. Functional foods, such as spirulina and turmeric, in the form of nutraceutics have been considered to exert not only an antioxidant effect but also modulate mechanisms in the metabolic pathways underlying cardiometabolic disruptions. We aimed to study the effectiveness of supplementation with a Spirulina maxima / Turmeric longa mixture (266 mg/156.6 mg) on body composition, lipemic, and antioxidant status in patients with abdominal obesity. To achieve this, 43 patients were included (control group, n = 21, and experimental, n = 22), in a double-blind randomized controlled trial. Both groups were daily supplemented, orally, for 12 weeks. After 3-month supplementation (altogether with individualized dietary management), both groups showed a decrease in body weight, fat mass, and abdominal circumference; however, no intergroup statistical differences were found. The same phenomenon was observed concerning biochemical metabolic markers; nevertheless, an obvious trend favoring spirulina/turmeric supplementation can be appreciated. Finally, both groups significantly increased their serum antioxidant status, although the supplemented groups showed a two-fold accrue vs. placebo.",2020,"After 3-month supplementation (altogether with individualized dietary management), both groups showed a decrease in body weight, fat mass, and abdominal circumference; however, no intergroup statistical differences were found.","['Patients With Abdominal Obesity', 'patients with abdominal obesity', '43 patients were included (control group, n = 21, and experimental, n = 22']","['placebo', 'Low-Dose Spirulina/Turmeric Supplement', 'supplementation with a Spirulina maxima / Turmeric longa mixture']","['body composition, lipemic, and antioxidant status', 'body weight, fat mass, and abdominal circumference', 'Cardiometabolic and Antioxidant Serum Markers', 'serum antioxidant status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1062691', 'cui_str': 'Spirulina maxima'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0460077', 'cui_str': 'Sample lipemic'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",43.0,0.0595482,"After 3-month supplementation (altogether with individualized dietary management), both groups showed a decrease in body weight, fat mass, and abdominal circumference; however, no intergroup statistical differences were found.","[{'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Gómez-Téllez', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad del Valle de Toluca, Mexico City, México.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Sierra-Puente', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Anáhuac México, Mexico City, México.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Muñoz-Gómez', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Anáhuac México, Mexico City, México.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Ibarra-Pitts', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Anáhuac México, Mexico City, México.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Guevara-Cruz', 'Affiliation': 'Departamento de Fisiología de la Nutrición, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, México.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Hernández-Ortega', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Anáhuac México, Mexico City, México.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Gutiérrez-Salmeán', 'Affiliation': 'Centro de Investigación en Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Anáhuac México, Mexico City, México.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00065'] 2069,32509870,RIRS with Vacuum-Assisted Ureteral Access Sheath versus MPCNL for the Treatment of 2-4 cm Renal Stone.,"Objective Comparison of outcomes between RIRS with vacuum-assisted ureteral access sheath (V-UAS) and MPCNL in the treatment of renal stone. Materials and Methods 28 patients with 2-4 cm renal stone were treated using RIRS with 14/16 F V-UAS. The outcomes were compared to those who underwent MPCNL with 16 F Amplatz sheath using a matched-pair analysis in a 1 : 2 scenario. Matching criteria included stone size, location and laterality, gender, age, BMI, and degree of hydronephrosis. Patients' demographics, perioperative and postoperative characteristics, complications, stone-free rate (SFR), and auxiliary procedures were compared. Results Mean operative times for the RIRS and MPCNL groups were 72.4 ± 21.3 minutes and 67.4 ± 25 minutes ( P = 0.042). Postoperative pain was significantly less in the RIRS group. The initial SFR was 50% for the RIRS group and 73.2% for the MPCNL group ( P = 0.035). The final SFR at postoperative three months improved to 89.3% for the RIRS group and 92.9% for the MPCNL group ( P = 0.681). The auxiliary procedure rates were higher in the RIRS group (42.9% vs. 25%, P = 0.095). The overall complication rate in the RIRS group was lower, but the significant difference was not found. Conclusion In the treatment of 2-4 cm renal stone, using V-UAS in RIRS can improve surgical efficiency with lower postoperative early pain scores. Comparing with MPCNL, its initial SFR was more depressed, and there is still a trend towards requiring more auxiliary procedures to achieve comparable final SFR.",2020,"The auxiliary procedure rates were higher in the RIRS group (42.9% vs. 25%, P = 0.095).",['28 patients with 2-4\u2009cm renal stone'],"['MPCNL', 'RIRS with vacuum-assisted ureteral access sheath (V-UAS) and MPCNL', 'RIRS with Vacuum-Assisted Ureteral Access Sheath versus MPCNL']","[""Patients' demographics, perioperative and postoperative characteristics, complications, stone-free rate (SFR), and auxiliary procedures"", 'initial SFR', 'overall complication rate', 'auxiliary procedure rates', 'Mean operative times', 'surgical efficiency', 'Postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",28.0,0.0327614,"The auxiliary procedure rates were higher in the RIRS group (42.9% vs. 25%, P = 0.095).","[{'ForeName': 'Dehui', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Urology, Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xingrong', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'College of Materials Science and Engineering, Key Lab of Guangdong Province for High Property and Functional Polymer Materials, South China University of Technology, Guangzhou, China.'}]",BioMed research international,['10.1155/2020/8052013'] 2070,32509889,Comparison of trauma-focused cognitive-behavioral therapy and theory of mind on increasing social competence among abused children.,"BACKGROUND In recent decades, the use of psychological methods has been considered to improve the barriers and challenges of abuse adolescent females. This study focuses on comparing the efficacy of trauma-focused cognitive-behavioral therapy (TF-CBT) and theory of mind (ToM) on social competence among abused children. MATERIALS AND METHODS A clinical trial was performed with 39 abused children as the subjects of the study. Participants are residents in Ahvaz (Iran) host-family centers and were randomly divided into two groups of experimental subjects and control subjects. The data collection method utilized the Social Competence Questionnaire. Descriptive statistics, covariance analysis, and Tukey's post hoc test were used for the data analysis. RESULTS Comparison of the groups showed that the average behavioral and cognitive competence increased in both TF-CBT and ToM groups, but the average emotional, social competence is significantly higher in the ToM group. It is also found that the average social motivational competence is significantly higher in the TF-CBT group than in the ToM group. CONCLUSION TF-CBT and ToM can be effectively used to improve the social competence of abused adolescent females.",2020,"Comparison of the groups showed that the average behavioral and cognitive competence increased in both TF-CBT and ToM groups, but the average emotional, social competence is significantly higher in the ToM group.","['abuse adolescent females', 'Participants are residents in Ahvaz (Iran) host-family centers', 'abused adolescent females', '39 abused children as the subjects of the study', 'abused children']","['TF-CBT and ToM', 'trauma-focused cognitive-behavioral therapy', 'trauma-focused cognitive-behavioral therapy (TF-CBT) and theory of mind (ToM', 'TF-CBT']","['social competence', 'average emotional, social competence', 'average behavioral and cognitive competence', 'average social motivational competence']","[{'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0562389', 'cui_str': 'Victim of child abuse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",39.0,0.00924666,"Comparison of the groups showed that the average behavioral and cognitive competence increased in both TF-CBT and ToM groups, but the average emotional, social competence is significantly higher in the ToM group.","[{'ForeName': 'Abdulzahra', 'Initials': 'A', 'LastName': 'Naami', 'Affiliation': 'Department of Psychology, University of Shahid Chamran Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Yadollah', 'Initials': 'Y', 'LastName': 'Zargar', 'Affiliation': 'Department of Psychology, University of Shahid Chamran Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Iran', 'Initials': 'I', 'LastName': 'Davoodi', 'Affiliation': 'Department of Psychology, University of Shahid Chamran Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Safora', 'Initials': 'S', 'LastName': 'Salemi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Faeze', 'Initials': 'F', 'LastName': 'Tatari', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khanegi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_380_19'] 2071,32509907,The effectiveness of metacognition therapy on the marital quality of the women.,"INTRODUCTION Marital quality is an important predictor of marital continuity, which can lead to mental health, well-being, and happiness for couples, and marital quality is equivalent to marital satisfaction and adjustment. This study was carried out to purpose the effectiveness of metacognition therapy on marital quality of women in the city of Isfahan. MATERIALS AND METHODS The research method was quasi-experimental with a pretest-posttest and control group design. The study population included all married women visiting consultation centers in the city of Isfahan during March 2018-March 2019. The sampling method was nonrandom voluntary sampling used to select 30 participants who were then randomly divided into experiment and control groups (15 individuals each). The research tool was the Revised Dyadic Adjustment Scale(RDAS). The experiment group participated in eight sessions of metacognition therapy, each lasting 90 min. Covariance analysis method was used to analyze the data via SPSS21. RESULTS The result of covariance analysis showed that metacognition therapy has been effective in improving the marital quality of the women in the city of Isfahan ( P < 0.01). CONCLUSION The results of this study emphasize that metacognition therapy is effective on the marital quality of the women in the city of Isfahan. Using this treatment plan can result in improved marital quality and marital satisfaction and therefore improve the relationship of couples. Therefore, the results of the current study can provide empirical support for the use of metacognition therapy to improve marital quality.",2020,"The result of covariance analysis showed that metacognition therapy has been effective in improving the marital quality of the women in the city of Isfahan ( P < 0.01). ","['women in the city of Isfahan', 'married women visiting consultation centers in the city of Isfahan during March 2018-March 2019', 'women']",['metacognition therapy'],"['marital quality and marital satisfaction', 'marital quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0193112,"The result of covariance analysis showed that metacognition therapy has been effective in improving the marital quality of the women in the city of Isfahan ( P < 0.01). ","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Aghabeygi', 'Affiliation': 'Department of Psychology, Khomeini Shahr Branch, Islamic Azad University, Khomeini Shahr, Isfahan, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Khanjani', 'Affiliation': 'Department of Psychology and Educational Science, Faculty of Humanities, Arak University, Arak,Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_5_20'] 2072,32509908,Using an educational program based on health belief model to improve the preventive behaviors of nurses against cardiovascular diseases.,"BACKGROUND An unhealthy lifestyle can threaten the health of nursing staff, especially in the context of cardiovascular diseases (CVDs). Considering the importance of health education in promoting preventive behaviors against these diseases, this study aimed to evaluate the effect of an educational program based on the health belief model (HBM) on improving preventive behaviors of nurses against CVDs. MATERIALS AND METHODS This is a randomized controlled trial with a pretest-posttest design conducted on 104 nursing staff of Imam Khomeini Hospital in Kuhdasht, Lorestan, Iran, in 2017. They were randomly assigned into two groups of HBM ( n = 52) and control ( n = 52). The HBM group received the educational intervention for 6 weeks, one session per week each for 30-40 min. They were measured before and after the intervention using a demographic form, a researcher-made HBM questionnaire, Baecke Habitual Physical Activity Questionnaire, and the 3-day food intake record all in Persian. The collected data were analyzed in the Statistical Package for the Social Sciences (SPSS) v. 24 software using the Chi-squared test and paired t -test. RESULTS The educational program could only increase the perceived severity (22.64 ± 2.22), perceived benefits (50.83 ± 5.22), and perceived self-efficacy (42.37 ± 5.93) of nurses in the HBM group compared to the controls ( P < 0.05). The nurses' perceived sensitivity was also increased, but it was not significant ( P > 0.05). In the HBM group, a significant change was found in the food intake level for energy ( t = 4.79, P = 0.000), protein ( t = -2.99, P = 0.004), and unsaturated fat ( t = -2.94, P = 0.005) after intervention. No significant difference was observed in the total physical activity score after the intervention ( P > 0.05). CONCLUSION An educational program based on the HBM model can be used to increase the severity, benefits, and self-efficacy of the nurses' preventive behaviors against CVDs and modify their dietary regime.",2020,"The educational program could only increase the perceived severity (22.64 ± 2.22), perceived benefits (50.83 ± 5.22), and perceived self-efficacy (42.37 ± 5.93) of nurses in the HBM group compared to the controls ( P < 0.05).","['nurses against cardiovascular diseases', '104 nursing staff of Imam Khomeini Hospital in Kuhdasht, Lorestan, Iran, in 2017']","['HBM', 'educational intervention']","['total physical activity score', 'food intake level for energy', 'HBM questionnaire, Baecke Habitual Physical Activity Questionnaire', 'unsaturated fat', 'perceived self-efficacy']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0243256,"The educational program could only increase the perceived severity (22.64 ± 2.22), perceived benefits (50.83 ± 5.22), and perceived self-efficacy (42.37 ± 5.93) of nurses in the HBM group compared to the controls ( P < 0.05).","[{'ForeName': 'Shahram Ghasemi', 'Initials': 'SG', 'LastName': 'Amraei', 'Affiliation': 'Department of Internal Medicine and Surgery, School of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Malekshahi', 'Affiliation': 'Department of Social Medicine, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Goudarzi', 'Affiliation': 'Social Determinants of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_620_19'] 2073,32509909,The effect of emotion regulation training on family relationships of hyperactive children.,"INTRODUCTION One of the psychiatric disorders related to childhood is attention deficit hyperactivity disorder that can negatively affect the family interactions of these children. Parents of these children, especially the mother as the main caregiver, need comprehensive training to make a positive difference in their attitudes and behaviors with these children. The purpose of this study was to investigate the effect of emotion regulation training on family relationships in hyperactive children. METHODS This was a randomized clinical trial study with a control group performed on eighty mothers of hyperactive children who were selected randomly. The intervention group members attended emotion regulation skills training sessions for one session of 90 min each week for 8 weeks. During the training course in the intervention group, the control group did not receive any training. Data collection tools included demographic information questionnaires, Mother-Child Relationship Evaluation, and Rahim Organizational Conflict Inventory-II. Data analysis was performed by descriptive statistics and the analysis of covariance. RESULTS The mean scores of the mother-child relationship in the intervention group showed a significant improvement in the subscales of acceptance, overprotection, facilitation, and rejection ( P < 0.0001). The results of this research also showed improvements in all the five communication styles of integrating, avoiding, compromising, obliging ( P < 0.0001), and dominating ( P < 0.012) between spouses. CONCLUSION It seems that the emotion regulation training approach in mothers with hyperactive children improved both the mother-child relationship and the interactive spousal styles and can be considered by the managers of treatment and rehabilitation field as an adjunctive therapy for the families of these children.",2020,"The mean scores of the mother-child relationship in the intervention group showed a significant improvement in the subscales of acceptance, overprotection, facilitation, and rejection ( P < 0.0001).","['mothers with hyperactive children', 'eighty mothers of hyperactive children who were selected randomly', 'hyperactive children']","['intervention group members attended emotion regulation skills training sessions', 'emotion regulation training', 'emotion regulation training approach', 'control group did not receive any training']","['demographic information questionnaires, Mother-Child Relationship Evaluation, and Rahim Organizational Conflict Inventory-II', 'subscales of acceptance, overprotection, facilitation, and rejection']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",,0.0240111,"The mean scores of the mother-child relationship in the intervention group showed a significant improvement in the subscales of acceptance, overprotection, facilitation, and rejection ( P < 0.0001).","[{'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Arabi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Ladan Fattah', 'Initials': 'LF', 'LastName': 'Moghaddam', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebalzamani', 'Affiliation': 'Department of Management, Faculty of Health, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_738_19'] 2074,32509972,Evaluation of an augmented reality platform for austere surgical telementoring: a randomized controlled crossover study in cricothyroidotomies.,"Telementoring platforms can help transfer surgical expertise remotely. However, most telementoring platforms are not designed to assist in austere, pre-hospital settings. This paper evaluates the system for telementoring with augmented reality (STAR), a portable and self-contained telementoring platform based on an augmented reality head-mounted display (ARHMD). The system is designed to assist in austere scenarios: a stabilized first-person view of the operating field is sent to a remote expert, who creates surgical instructions that a local first responder wearing the ARHMD can visualize as three-dimensional models projected onto the patient's body. Our hypothesis evaluated whether remote guidance with STAR could lead to performing a surgical procedure better, as opposed to remote audio-only guidance. Remote expert surgeons guided first responders through training cricothyroidotomies in a simulated austere scenario, and on-site surgeons evaluated the participants using standardized evaluation tools. The evaluation comprehended completion time and technique performance of specific cricothyroidotomy steps. The analyses were also performed considering the participants' years of experience as first responders, and their experience performing cricothyroidotomies. A linear mixed model analysis showed that using STAR was associated with higher procedural and non-procedural scores, and overall better performance. Additionally, a binary logistic regression analysis showed that using STAR was associated to safer and more successful executions of cricothyroidotomies. This work demonstrates that remote mentors can use STAR to provide first responders with guidance and surgical knowledge, and represents a first step towards the adoption of ARHMDs to convey clinical expertise remotely in austere scenarios.",2020,"A linear mixed model analysis showed that using STAR was associated with higher procedural and non-procedural scores, and overall better performance.",['austere surgical telementoring'],['augmented reality platform'],['higher procedural and non-procedural scores'],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.019447,"A linear mixed model analysis showed that using STAR was associated with higher procedural and non-procedural scores, and overall better performance.","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Rojas-Muñoz', 'Affiliation': 'School of Industrial Engineering, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Computer Science, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Sanchez-Tamayo', 'Affiliation': 'School of Industrial Engineering, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Cabrera', 'Affiliation': 'Paul G. Allen School of Computer Science and Engineering, University of Washington, Seattle, WA USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Andersen', 'Affiliation': 'Department of Computer Science, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Voicu', 'Initials': 'V', 'LastName': 'Popescu', 'Affiliation': 'Department of Computer Science, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Barragan', 'Affiliation': 'School of Industrial Engineering, Purdue University, West Lafayette, IN USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Zarzaur', 'Affiliation': 'Department of Surgery, School of Medicine, Indiana University, Indianapolis, IN USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'Department of Surgery, School of Medicine, Indiana University, Indianapolis, IN USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Department of Surgery, School of Medicine, Indiana University, Indianapolis, IN USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Douglas', 'Affiliation': 'Naval Medical Center Portsmouth, Portsmouth, VA USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffis', 'Affiliation': 'Naval Medical Center Portsmouth, Portsmouth, VA USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McKee', 'Affiliation': 'Department of Surgery, and the Regional Trauma Services, University of Calgary, Calgary, AB Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Surgery, and the Regional Trauma Services, University of Calgary, Calgary, AB Canada.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wachs', 'Affiliation': 'School of Industrial Engineering, Purdue University, West Lafayette, IN USA.'}]",NPJ digital medicine,['10.1038/s41746-020-0284-9'] 2075,32510011,Topical Bromfenac Sodium in Femtosecond Laser-Assisted Cataract Surgery.,"Purpose To evaluate the effect of preoperative 0.09% bromfenac ophthalmic solution for the reduction of intraoperative miosis and pain in patients who have undergone femtosecond laser-assisted cataract surgery. Methods This prospective randomized clinical study included 65 patients with senile cataracts in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery, and pain quantification was assessed by an analogous pain scale after one day of follow-up. Results A total of 65 patients were randomly divided into two groups. Five patients were excluded due to defective coupling with the laser interface. Each of the 60 patients was randomized to receive preoperative topical treatment with either 0.09% bromfenac or 0.1% sodium hyaluronate. Baseline characteristics were similar between groups for age and gender. The mean change in horizontal and vertical pupil diameter from the preoperative to post-femtosecond laser measurements were significantly less in the bromfenac group than in the placebo group (0.43 ± 0.6 vs. 1.71 ± 0.9, P < 0.001 and 0.40 ± 0.6 vs. 1.78 ± 0.9, P < 0.001, respectively). Compared with untreated patients, the quantification of pain one day after the procedure was significantly lower in the 0.09% bromfenac group (46.7% with a score of 3 vs. 50% with a score of 1, P < 0.001, respectively). Conclusions The maintenance of pupil dilation and the prevention of miosis were more effective in the 0.09% bromfenac group than in the control group. Likewise, the greater control of postoperative pain represented an additional significant benefit.",2020,"The mean change in horizontal and vertical pupil diameter from the preoperative to post-femtosecond laser measurements were significantly less in the bromfenac group than in the placebo group (0.43 ± 0.6 vs. 1.71 ± 0.9, P < 0.001 and 0.40 ± 0.6 vs. 1.78 ± 0.9, P < 0.001, respectively).","['patients who have undergone femtosecond laser-assisted cataract surgery', 'Five patients were excluded due to defective coupling with the laser interface', '65 patients with senile cataracts in the absence of significant ocular comorbidity', '60 patients', '65 patients']","['preoperative 0.09% bromfenac ophthalmic solution', 'bromfenac ophthalmic solution or control placebo', 'Femtosecond Laser-Assisted Cataract Surgery', 'preoperative topical treatment with either 0.09% bromfenac or 0.1% sodium hyaluronate', 'Topical Bromfenac Sodium', 'placebo']","['pain quantification', 'quantification of pain', 'mean change in horizontal and vertical pupil diameter', 'postoperative pain', 'intraoperative miosis and pain', 'pain scale', 'Pupil diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0036646', 'cui_str': 'Senile cataract'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C1618765', 'cui_str': 'bromfenac Ophthalmic Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0107211', 'cui_str': 'Bromfenac sodium'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1626415', 'cui_str': 'Intraoperative miosis'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",65.0,0.129903,"The mean change in horizontal and vertical pupil diameter from the preoperative to post-femtosecond laser measurements were significantly less in the bromfenac group than in the placebo group (0.43 ± 0.6 vs. 1.71 ± 0.9, P < 0.001 and 0.40 ± 0.6 vs. 1.78 ± 0.9, P < 0.001, respectively).","[{'ForeName': 'María Camila', 'Initials': 'MC', 'LastName': 'Aguilar Sierra', 'Affiliation': 'Anterior Segment Department, Fundacion Hospital Nuestra Señora de la Luz, Mexico.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Alvarado-Villacorta', 'Affiliation': 'Cornea and Refractive Department, Asociacion Para Evitar la Ceguera en Mexico, Mexico.'}, {'ForeName': 'Claudia Palacio', 'Initials': 'CP', 'LastName': 'Pastrana', 'Affiliation': 'Anterior Segment Department, Fundacion Hospital Nuestra Señora de la Luz, Mexico.'}]",Journal of current ophthalmology,['10.1016/j.joco.2019.07.007'] 2076,32510158,Nondigestible Carbohydrates Affect Metabolic Health and Gut Microbiota in Overweight Adults after Weight Loss.,"BACKGROUND The composition of diets consumed following weight loss (WL) can have a significant impact on satiety and metabolic health. OBJECTIVE This study was designed to test the effects of including a nondigestible carbohydrate to achieve weight maintenance (WM) following a period of WL. METHODS Nineteen volunteers [11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42] consumed a 3-d maintenance diet (15%:30%:55%), followed by a 21-d WL diet (WL; 30%:30%:40%), followed by 2 randomized 10-d WM diets (20%:30%:50% of energy from protein:fat:carbohydrate) containing either resistant starch type 3 (RS-WM; 22 or 26 g/d for females and males, respectively) or no RS (C-WM) in a within-subject crossover design without washout periods. The primary outcome, WM after WL, was analyzed by body weight. Secondary outcomes of fecal microbiota composition and microbial metabolite concentrations and gut hormones were analyzed in fecal samples and blood plasma, respectively. All outcomes were assessed at the end of each dietary period. RESULTS Body weight was similar after the RS-WM and C-WM diets (90.7 and 90.8 kg, respectively), with no difference in subjectively rated appetite. During the WL diet period plasma ghrelin increased by 36% (P < 0.001), glucose-dependent insulinotropic polypeptide (GIP) decreased by 33% (P < 0.001), and insulin decreased by 46% (P < 0.001), but no significant differences were observed during the RS-WM and C-WM diet periods. Fasting blood glucose was lower after the RS-WM diet (5.59 ± 0.31 mmol/L) than after the C-WM diet [5.75 ± 0.49 mmol/L; P = 0.015; standard error of the difference between the means (SED): 0.09]. Dietary treatments influenced the fecal microbiota composition (R2 = 0.054, P = 0.031) but not diversity. CONCLUSIONS The metabolic benefits, for overweight adults, from WL were maintained through a subsequent WM diet with higher total carbohydrate intake. Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite. This trial was registered at clinicaltrials.gov as NCT01724411.",2020,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","['Overweight Adults after Weight Loss', 'Nineteen volunteers', '11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42']","['Nondigestible Carbohydrates', 'nondigestible carbohydrate', 'resistant starch type 3 (RS-WM']","['glucose-dependent insulinotropic polypeptide (GIP', 'weight maintenance (WM', 'fecal samples and blood plasma', 'plasma ghrelin', 'insulin', 'Fasting blood glucose', 'appetite', 'Body weight', 'fecal microbiota composition and microbial metabolite concentrations and gut hormones', 'fecal microbiota composition', 'gut microbiota composition', 'subjectively rated appetite', 'lower fasting glucose']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",19.0,0.0602516,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Reyna', 'Initials': 'R', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McKinnon', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fyfe', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Naslund', 'Affiliation': 'Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Lopez-Nicolas', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bonnema', 'Affiliation': 'Cargill R&D Centre NA, Minneapolis, MN, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Frontela-Saseta', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Gaspar', 'Initials': 'G', 'LastName': 'Ros-Berruezo', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, United Kingdom.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Ze', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Harrold', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Halford', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Silvia W', 'Initials': 'SW', 'LastName': 'Gratz', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Sylvia H', 'Initials': 'SH', 'LastName': 'Duncan', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Shirazi-Beechey', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Flint', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa124'] 2077,32510169,A study on clinical effect of Arbidol combined with adjuvant therapy on COVID-19.,"OBJECTIVES This study aims to explore the clinical effect of Arbidol (ARB) combined with adjuvant therapy on patients with coronavirus disease 2019 (COVID-19). METHODS The study included 62 patients with COVID-19 admitted to the First Hospital of Jiaxing from January to March, 2020, and all patients were divided into the test group and the control group according to whether they received ARB during hospitalization. Various indexes in the two groups before and after treatment were observed and recorded, including fever, cough, hypodynamia, nasal obstruction, nasal discharge, diarrhea, C-reactive protein (CRP), procalcitonin (PCT), blood routine indexes, blood biochemical indexes, time to achieve negative virus nucleic acid and so on. RESULTS The fever and cough in the test group were relieved markedly faster than those in the control group (p<0.05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5 ± 7.14) d and (18.55 ± 7.52) d, respectively. CONCLUSION ARB combined with adjuvant therapy might be able to relieve the fever of COVID-19 sufferers faster and accelerate the cure time to some degree, hence it's recommended for further research clinically. This article is protected by copyright. All rights reserved.",2020,"The fever and cough in the test group were relieved markedly faster than those in the control group (p<0.05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5 ± 7.14) d and (18.55 ± 7.52) d, respectively. ","['patients with coronavirus disease 2019 (COVID-19', '62 patients with COVID-19 admitted to the First Hospital of Jiaxing from January to March, 2020, and all patients']","['Arbidol (ARB) combined with adjuvant therapy', 'ARB combined with adjuvant therapy', 'Arbidol combined with adjuvant therapy']","['fever, cough, hypodynamia, nasal obstruction, nasal discharge, diarrhea, C-reactive protein (CRP), procalcitonin (PCT), blood routine indexes, blood biochemical indexes, time to achieve negative virus nucleic acid and so on', 'abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests', 'fever and cough']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0242684', 'cui_str': 'Hypodynamia'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",62.0,0.0182083,"The fever and cough in the test group were relieved markedly faster than those in the control group (p<0.05); there was no obvious difference between the two groups concerning the percentage of patients with abnormal CRP, PCT, blood routine indexes, aspartate aminotransferase and alanine aminotransferase (p>0.05); the time for two consecutive negative nucleic acid tests in the test group were shorter than that in the control group; the hospitalization period of the patients in the test group and control group were (16.5 ± 7.14) d and (18.55 ± 7.52) d, respectively. ","[{'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'The Department of Respiration in Affiliated Hospital of Jiaxing University /The First Hospital of Jiaxing, Jiaxing, 314000, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Center for Pain Medicine in Affiliated Hospital of Jiaxing University/The First Hospital of Jiaxing, Jiaxing, 314000, China.'}, {'ForeName': 'Zhixian', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'The Department of Respiration in Affiliated Hospital of Jiaxing University /The First Hospital of Jiaxing, Jiaxing, 314000, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'The Department of Respiration in Affiliated Hospital of Jiaxing University /The First Hospital of Jiaxing, Jiaxing, 314000, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Deng', 'Affiliation': 'The Department of Infectious Disease in Affiliated Hospital of Jiaxing University /The First Hospital of Jiaxing, Jiaxing, 314000, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'The Department of Orthopedics, Tongde Hospital of Zhejiang Province, Hangzhou, 310012, China.'}]",Journal of medical virology,['10.1002/jmv.26142'] 2078,32510238,Evaluation of abdominal exercises after stoma surgery: a descriptive study.,"Purpose: To evaluate the feasibility of exercises for the abdominal muscles in patients after colostomy or ileostomy formation on the following parameters: muscle activity, pain, discomfort, and difficulty of performing the exercises. Materials and methods: Patients with a new stoma were divided into groups based on time after surgery: Early group, 0-2 weeks ( n  = 12); Intermediate group, 2-6 weeks ( n  = 15); and Late group, 6-12 weeks ( n  = 10). During a single individual test session, participants in each group performed a different set of 10-11 abdominal coordination and strengthening exercises for the abdominal muscles. Activity of the abdominal muscles was measured with electromyography. Pain, discomfort, and difficulty were rated for each exercise. Results: For the Early group, muscle activity reaching a predetermined threshold was measured for half of the participants in a few exercises. In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises. Both strengthening and coordinating exercises were feasible based on low ratings of pain, discomfort, and difficulty. Conclusions: This study identified feasible exercises that activated the abdominal muscles at different time points after stoma formation. The observations can be used as guidance for the choice of exercises in clinical practice and future research.Implications for rehabilitationThe findings of this study can be used in clinical practice as guidance for choice of exercise at different time points after surgery.This study identified useful exercises for activating the abdominal muscles in rehabilitation after stoma surgery from two weeks on.In the first two postoperative weeks, there was limited involvement of the abdominal muscles with the evaluated exercises.Most of the evaluated abdominal exercises were feasible after stoma surgery based on pain, discomfort, and difficulty.",2020,"In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises.","['patients after colostomy or ileostomy formation on the following parameters', 'after stoma surgery', 'Patients with a new stoma']","['abdominal exercises', '10-11 abdominal coordination and strengthening exercises']","['muscle activity', 'muscle activity, pain, discomfort, and difficulty of performing the exercises', 'Pain, discomfort, and difficulty', 'muscle activity reaching', 'Activity of the abdominal muscles', 'pain, discomfort, and difficulty']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0454354', 'cui_str': 'Abdominal exercises'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}]",,0.0217735,"In both the Intermediate group and the Late group, muscle activity reaching the onset criteria was measured for all muscles for a high percentage of participants in several exercises.","[{'ForeName': 'Rune Martens', 'Initials': 'RM', 'LastName': 'Andersen', 'Affiliation': 'Department of Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thordis', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Department of Anesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kjærgaard', 'Initials': 'AK', 'LastName': 'Danielsen', 'Affiliation': 'Department of Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Alkjær', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tyge', 'Initials': 'T', 'LastName': 'Nordentoft', 'Affiliation': 'Department of Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Possfelt-Møller', 'Affiliation': 'Department of Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Vinther', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte, Copenhagen, Denmark.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1771620'] 2079,32510462,Effectiveness of a 3-Month Mobile Phone-Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial.,"BACKGROUND Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking. OBJECTIVE The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA). METHODS For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months. RESULTS No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day. CONCLUSIONS No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA. TRIAL REGISTRATION ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s12889-018-5658-4.",2020,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","['254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone', 'Adults', '254 participants']","['3-Month Mobile Phone-Based Behavior Change Program', '3-month behavior change program to promote AT (TravelVu Plus app', 'mobile phone app to promote AT (TravelVu Plus', 'MVPA']","['MVPA', 'Active Transportation and Physical Activity', 'AT, attitudes toward AT, and health-related quality of life at 3 and 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",254.0,0.218912,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Department of Clinical Science Intervention and Technology, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Emmie', 'Initials': 'E', 'LastName': 'Söderström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'eHealth Institute, Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Delisle Nyström', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Direito', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Eriksson', 'Affiliation': 'Strömstad Academy, Strömstad, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Department of Medicine, Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/18531'] 2080,32510573,Hyperhidrosis Quality of Life Index (HidroQoL©): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III RCT.,"BACKGROUND The Hyperhidrosis Quality of Life Index (HidroQoL©) is a validated patient-reported outcome measure capturing the quality of life of people affected by hyperhidrosis. We aimed to extend the validity evidence to physician-confirmed diagnosis of primary axillary hyperhidrosis. METHODS Data from a phase 3 randomized placebo-controlled clinical trial were used (n = 171). Confirmatory factor analysis was carried out to confirm a priori two-factor structure of the HidroQoL. Internal consistency was assessed using Cronbach's alpha. Intraclass correlation coefficients (ICCs) were calculated to evaluate test-retest reliability after 4 to 7 days. Convergent validity was assessed using correlations with the Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS) and gravimetric sweat production. Known groups were analyzed to evaluate discriminative validity. Responsiveness after 29 days was assessed and minimal important difference (MID) values were calculated using both anchor- and distribution-based approaches. All analyses were carried out for total HidroQoL and its two domains. RESULTS The two-factor structure of the HidroQoL could be confirmed. Internal consistency and test-retest reliability were strong (Cronbach's α: 0.81-0.90; ICCs: 0.89-0.93). Correlations with other outcome measures were in line with a priori hypotheses. The HidroQoL discriminated between different severity groups (p ≤ .001) and showed sensitivity to change towards improvement (p < .001). An MID value of 4 is proposed for the total scale. CONCLUSION This study supports excellent measurement properties including clinical applicability of the HidroQoL in primary axillary hyperhidrosis and suggests an MID of 4 to be applied to clinical trial data.",2020,The HidroQoL discriminated between different severity groups (p ≤ .001) and showed sensitivity to change towards improvement (p < .001).,['patients with axillary hyperhidrosis using data from a phase III RCT'],"['HidroQoL', 'placebo']","['Dermatology Life Quality Index (DLQI), the Hyperhidrosis Disease Severity Scale (HDSS) and gravimetric sweat production', 'Internal consistency and test-retest reliability', 'Intraclass correlation coefficients (ICCs', 'minimal important difference (MID) values', 'Hyperhidrosis Quality of Life Index (HidroQoL©', 'Life Index (HidroQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",171.0,0.0777212,The HidroQoL discriminated between different severity groups (p ≤ .001) and showed sensitivity to change towards improvement (p < .001).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gabes', 'Affiliation': 'Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jourdan', 'Affiliation': 'FGK Clinical Research GmbH, Munich, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schramm', 'Affiliation': 'FGK Clinical Research GmbH, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Masur', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Abels', 'Affiliation': 'Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kamudoni', 'Affiliation': 'Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salek', 'Affiliation': 'School of Life and Medical Sciences, University of Hertfordshire, Hertfordshire, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Apfelbacher', 'Affiliation': 'Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19300'] 2081,32506744,Altered activation in sensorimotor network after applying rTMS over the primary motor cortex at different frequencies.,"INTRODUCTION Repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex (M1) can modulate brain activity both in the stimulated site and remote brain areas of the sensorimotor network. However, the modulatory effects of rTMS at different frequencies remain unclear. Here, we employed finger-tapping task-based fMRI to investigate alterations in activation of the sensorimotor network after the application of rTMS over the left M1 at different frequencies. MATERIALS AND METHODS Forty-five right-handed healthy participants were randomly divided into three groups by rTMS frequency (HF, high-frequency, 3 Hz; LF, low-frequency, 1 Hz; and SHAM) and underwent two task-fMRI sessions (RH, finger-tapping with right index finger; LH, finger-tapping with left index finger) before and after applying rTMS over the left M1. We defined regions of interest (ROIs) in the sensorimotor network based on group-level activation maps (pre-rTMS) from RH and LH tasks and calculated the percentage signal change (PSC) for each ROI. We then assessed the differences of PSC within HF or LF groups and between groups. RESULTS Application of rTMS at different frequencies resulted in a change in activation of several areas of the sensorimotor network. We observed the increased PSC in M1 after high-frequency stimulation, while we detected the reduced PSC in the primary sensory cortex (S1), ventral premotor cortex (PMv), supplementary motor cortex (SMA), and putamen after low-frequency stimulation. Moreover, the PSC in the SMA, dorsal premotor cortex (PMd), and putamen in the HF group was higher than in the LF group after stimulation. CONCLUSION Our findings suggested that activation alterations within sensorimotor network are dependent on the frequency of rTMS. Therefore, our findings contribute to understanding the effects of rTMS on brain activation in healthy individuals and ultimately may further help to suggest mechanisms of how rTMS could be employed as a therapeutic tool.",2020,"Moreover, the PSC in the SMA, dorsal premotor cortex (PMd), and putamen in the HF group was higher than in the LF group after stimulation. ","['Forty-five right-handed healthy participants', 'healthy individuals']","['rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS frequency (HF, high-frequency, 3\xa0Hz; LF, low-frequency, 1\xa0Hz; and SHAM) and underwent two task-fMRI sessions (RH, finger-tapping with right index finger; LH, finger-tapping with left index finger']","['SMA, dorsal premotor cortex (PMd), and putamen', 'primary sensory cortex (S1), ventral premotor cortex (PMv), supplementary motor cortex (SMA), and putamen after low-frequency stimulation']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0230388', 'cui_str': 'Index finger structure'}]","[{'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",45.0,0.0177725,"Moreover, the PSC in the SMA, dorsal premotor cortex (PMd), and putamen in the HF group was higher than in the LF group after stimulation. ","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, China.'}, {'ForeName': 'Guo-Feng', 'Initials': 'GF', 'LastName': 'Huang', 'Affiliation': 'School of Information and Electronics Technology, Jiamusi University, Jiamusi, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Information and Electronics Technology, Jiamusi University, Jiamusi, China.'}, {'ForeName': 'Hui-Bin', 'Initials': 'HB', 'LastName': 'Ma', 'Affiliation': 'School of Information and Electronics Technology, Jiamusi University, Jiamusi, China.'}, {'ForeName': 'Yating', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, China.'}]",Brain and behavior,['10.1002/brb3.1670'] 2082,32506827,"Safety, Pharmacokinetics and Pharmacodynamics of TD-0714, a Novel Potent Neprilysin Inhibitor in Healthy Adult and Elderly Subjects.","TD-0714 is an orally active, potent, and selective inhibitor of human neprilysin (hNEP) in development for the treatment of chronic heart failure. Oral administration of TD-0714 in rats resulted in dose-dependent and sustained increases in plasma cyclic guanosine monophosphate (cGMP) over 24 hours consistent with NEP target engagement. Randomized, double-blind, placebo controlled, single ascending dose (SAD; 50 to 600 mg TD-0714) and multiple ascending dose (MAD; 10 to 200 mg TD-0714 QD for 14 days) studies were conducted in healthy volunteers. TD-0714 was generally well tolerated and no serious adverse events (SAEs) or clinically significant effects on vital signs or electrocardiogram parameters were observed. TD-0714 exhibited dose-proportional pharmacokinetics with high oral bioavailability, minimal accumulation after once daily dosing and negligible renal elimination. Pharmacodynamic (PD) responses were observed at all dose levels studied as reflected by statistically significant increases in plasma cGMP concentrations. The increases in cGMP were significantly above the baseline (~50-100%) on Day 14 for the entire 24 hr interval indicating that sustained cGMP elevations are achieved at steady state. Maximal steady-state cGMP response was observed in plasma and urine at doses ≥50 mg. The TD-0714 PK-PD relationship and safety profile was similar in elderly vs. younger adult subjects. The TD-0714 PK and PD profiles support further clinical development of TD-0714 and suggest the potential for once-daily administration and predictable exposure in patients with cardiorenal diseases regardless of their renal function.",2020,Pharmacodynamic (PD) responses were observed at all dose levels studied as reflected by statistically significant increases in plasma cGMP concentrations.,"['patients with cardiorenal diseases regardless of their renal function', 'Healthy Adult and Elderly Subjects', 'elderly vs. younger adult subjects', 'healthy volunteers']","['TD-0714', 'selective inhibitor of human neprilysin (hNEP', 'placebo']","['plasma cGMP concentrations', 'TD-0714 PK-PD relationship and safety profile', 'vital signs or electrocardiogram parameters', 'tolerated and no serious adverse events (SAEs', 'cGMP', 'plasma cyclic guanosine monophosphate (cGMP', 'Pharmacodynamic (PD) responses', 'Maximal steady-state cGMP response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0319265,Pharmacodynamic (PD) responses were observed at all dose levels studied as reflected by statistically significant increases in plasma cGMP concentrations.,"[{'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kanodia', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Lo', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}, {'ForeName': 'R Michael', 'Initials': 'RM', 'LastName': 'Baldwin', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Colley', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bourdet', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, USA.'}]",Clinical and translational science,['10.1111/cts.12831'] 2083,32506857,"""Effectiveness of Jinying capsule on pelvic inflammatory disease in patients with symptom pattern of damp and heat accumulation: a double-blinded, multicenter, randomized, placebo-controlled clinical trial"".","OBJECTIVE To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease (PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine (TCM). METHODS We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group (n = 78) and control group (n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d. They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge, and pelvic ultrasound. RESULTS Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant (P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1 (P = 0.0131), and 73.33% of the experimental group and 56.94% of the control group at week 4 (P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes (all P > 0.05). No adverse events or reactions occurred in the experimental groups. CONCLUSION Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.",2020,"No adverse events or reactions occurred in the experimental groups. ","['patients with symptom pattern of damp and heat accumulation', '155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation', 'patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine (TCM']","['Jinying capsule', 'Jinying capsule placebo', 'Jinying capsules and oral levofloxacin plus oral metronidazole', 'oral levofloxacin and metronidazole and Jinying capsule placebo', 'levofloxacin placebo and metronidazole placebo', 'placebo']","['cure rate', 'TCM symptom pattern scores', 'total effective rate', 'Physicochemical indexes', 'pelvic inflammatory disease (PID', 'McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge, and pelvic ultrasound', 'curative effect rate', 'curative effect', 'pelvic inflammatory disease', 'adverse events or reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0436318', 'cui_str': 'Symptom pattern'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242172', 'cui_str': 'Female pelvic inflammatory disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0436318', 'cui_str': 'Symptom pattern'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242172', 'cui_str': 'Female pelvic inflammatory disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0948766', 'cui_str': 'Ultrasound pelvis'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.060729,"No adverse events or reactions occurred in the experimental groups. ","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Clinical Pharmacological Base, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Deping', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Emergency Gynecology, Chongqing health center for women and children, Chongqing 401147, China.'}, {'ForeName': 'Fenglan', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': 'Department of Obstetrics and Gynecology, Chinese medicine hospital of Handan, Hebei 056000, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology and Reproductive Medicine, The secondary hospital affiliated to Shanxi university of Chinese Medicine, Shanxi 712000, China.'}, {'ForeName': 'Shuqiong', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecology, Hunan Health Center for Women and Children, Changsha 410008, China.'}, {'ForeName': 'Qiufeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Chinese medicine hospital of Luohe, Luohe 462000, China.'}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics, People's Hospital of Xinzhou, Xinzhou 034000, China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Gynecology, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecology, Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.03.011'] 2084,32506858,Comparative efficacy of honey 12.5% and chlorhexidine 0.2% mouthwashes on the oropharyngeal bacterial colonization in mechanically-ventilated patients: a randomized controlled trial.,"OBJECTIVE To compare the efficacy of honey mouthwash 12.5% and chlorhexidine solution 0.2% to reduce the rate of oropharyngeal bacterial colonization in mechanically-ventilated patients. METHODS This study was a randomized, single blind, phase Ⅲ controlled clinical trial. Sixty patients newly admitted to internal and trauma Intensive Care Units of the two educational hospitals of Sanandaj city affiliated with Kurdistan University of Medical Sciences were selected by convenience sampling and allocated to two groups of 30 patients using random blocks design. In each group, the mouthwash was applied twice a day for four consecutive days. Swab samples were taken from the mouth and throat of all patients three times a day (pre- intervention, two days, and four days after the intervention) and then the samples were transferred onto the blood agar and eosin methylene blue (EMB) culture plates and investigated for bacterial growth and colonization after 24-48 h. RESULTS The findings showed that oropharyngeal colonization was not significantly different between the two groups, pre-intervention, two days, and four days after the intervention (P > 0.05). Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. CONCLUSION None of the studied solutions contributed to the reduction of oropharyngeal bacterial colonization. It seems that the growth inhibition of Staphylococcus aureus and Pseudomonas aeruginosa by the honey 12.5% mouthwash in mechanically-ventilated patients need further investigation.",2020,"Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. ","['mechanically-ventilated patients', 'Sixty patients newly admitted to internal and trauma Intensive Care Units of the two educational hospitals of Sanandaj city affiliated with Kurdistan University of Medical Sciences']","['chlorhexidine 0.2% mouthwashes', 'chlorhexidine solution']","['oropharyngeal bacterial colonization', 'rate of oropharyngeal bacterial colonization', 'oropharyngeal colonization']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C4047661', 'cui_str': 'Trauma intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}]",60.0,0.0831672,"Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. ","[{'ForeName': 'Amiri', 'Initials': 'A', 'LastName': 'Halimeh', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan 4515613191, Iran.'}, {'ForeName': 'Ramezani-Badr', 'Initials': 'RB', 'LastName': 'Farhad', 'Affiliation': 'Department of Critical Care Nursing, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan 4515613191, Iran.'}, {'ForeName': 'Sigari', 'Initials': 'S', 'LastName': 'Naseh', 'Affiliation': 'Department of Intrenal Medicine, Kurdistan University of Medical Sciences, Sanandaj 66614713446, Iran.'}, {'ForeName': 'Nasseri', 'Initials': 'N', 'LastName': 'Karim', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj 66614713446, Iran.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.03.012'] 2085,32506859,Effectiveness and clinical benefit of a therapy of combined non-pharmaceutical Traditional Chinese Medicine for knee osteoarthritis: a randomized controlled study.,"OBJECTIVE To compare the efficacy of honey mouthwash 12.5% and chlorhexidine solution 0.2% to reduce the rate of oropharyngeal bacterial colonization in mechanically-ventilated patients. METHODS This study was a randomized, single blind, phase Ⅲ controlled clinical trial. Sixty patients newly admitted to internal and trauma Intensive Care Units of the two educational hospitals of Sanandaj city affiliated with Kurdistan University of Medical Sciences were selected by convenience sampling and allocated to two groups of 30 patients using random blocks design. In each group, the mouthwash was applied twice a day for four consecutive days. Swab samples were taken from the mouth and throat of all patients three times a day (pre- intervention, two days, and four days after the intervention) and then the samples were transferred onto the blood agar and eosin methylene blue (EMB) culture plates and investigated for bacterial growth and colonization after 24-48 h. RESULTS The findings showed that oropharyngeal colonization was not significantly different between the two groups, pre-intervention, two days, and four days after the intervention (P > 0.05). Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. CONCLUSION None of the studied solutions contributed to the reduction of oropharyngeal bacterial colonization. It seems that the growth inhibition of Staphylococcus aureus and Pseudomonas aeruginosa by the honey 12.5% mouthwash in mechanically-ventilated patients need further investigation.",2020,"Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. ","['knee osteoarthritis', 'mechanically-ventilated patients', 'Sixty patients newly admitted to internal and trauma Intensive Care Units of the two educational hospitals of Sanandaj city affiliated with Kurdistan University of Medical Sciences']","['chlorhexidine solution', 'combined non-pharmaceutical Traditional Chinese Medicine']","['oropharyngeal bacterial colonization', 'rate of oropharyngeal bacterial colonization', 'oropharyngeal colonization']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C4047661', 'cui_str': 'Trauma intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}]",60.0,0.0828009,"Rinsing with honey mouthwash 12.5% led to the inhibition of Staphylococcus aureus and Pseudomonas aeruginosa on the fourth day of the intervention in all samples. ","[{'ForeName': 'Lele', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional Chinese Medicine, the First Affiliated Hospital of Henan University of Science and Technology, Clinical Medical College of Henan University of Science and Technology, Luoyang 471003, China.'}, {'ForeName': 'Haixin', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Traditional Chinese Medicine, the First Affiliated Hospital of Henan University of Science and Technology, Clinical Medical College of Henan University of Science and Technology, Luoyang 471003, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.03.013'] 2086,32506860,Wrist-ankle acupuncture and Fluoxetine in the treatment of post-stroke depression: a randomized controlled clinical trial.,"OBJECTIVE To investigate the effects of WAA combined with fluoxetine in the clinical treatment of post-stroke depression (PSD) . METHODS In this randomized, controlled and single-blind trial, 105 PSD patients who met the inclusion criteria were randomly divided into three equal groups: Thin wrist-ankle acupuncture (WAA) group (Thin WAA needle + Fluoxetine), Thick WAA group (Thick WAA needle + Fluoxetine), and Sham WAA group (sham WAA needle + Fluoxetine). In this trial, the primary outcome was Hamilton Depression Scale (HAMD), while the secondary outcomes included Zung self-rating depression scale (SDS) and World Health Organization Quality of Life BREF (QQL). RESULTS Ninety nine PSD patients completed all the treatment. The HAMD scores and SDS scores of all the three groups decreased after treatment (P < 0.05); thick WAA group and thin WAA group decreased more obviously than the sham WAA group (P < 0.05). There was no significant difference between the QQL scores of the three groups (P > 0.05). There was no significant difference in the scores of the three scales between the thick wrist ankle needles and the thin wrist ankle needles (P > 0.05). CONCLUSION The present study showed that WAA combined with fluoxetine can relieve the symptoms of depression after stroke. WAA therapy could improve the antidepressant effect of fluoxetine.",2020,"There was no significant difference in the scores of the three scales between the thick wrist ankle needles and the thin wrist ankle needles (P > 0.05). ","['105 PSD patients who met the inclusion criteria', 'post-stroke depression (PSD) ', 'Ninety nine PSD patients', 'post-stroke depression']","['fluoxetine', 'Thin wrist-ankle acupuncture (WAA) group (Thin WAA needle + Fluoxetine), Thick WAA group (Thick WAA needle + Fluoxetine), and Sham WAA group (sham WAA needle + Fluoxetine', 'Wrist-ankle acupuncture and Fluoxetine', 'WAA combined with fluoxetine']","['Hamilton Depression Scale (HAMD', 'HAMD scores and SDS scores', 'QQL scores', 'thick wrist ankle needles and the thin wrist ankle needles', 'Zung self-rating depression scale (SDS) and World Health Organization Quality of Life BREF (QQL']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",105.0,0.0264817,"There was no significant difference in the scores of the three scales between the thick wrist ankle needles and the thin wrist ankle needles (P > 0.05). ","[{'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University, Shanghai 200433, China.'}, {'ForeName': 'Tianfang', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University, Shanghai 200433, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Shu', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University, Shanghai 200433, China.'}, {'ForeName': 'Xiaolu', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Department of Traditional Chinese Medicine, Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University, Shanghai 200433, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture-Moxibustion and Tuina, Shanghai university of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yao', 'Affiliation': 'Acupuncture-Moxibustion and Tuina, Shanghai university of Traditional Chinese Medicine, Shanghai 201203, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.03.014'] 2087,32506975,Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease.,"INTRODUCTION Interstitial lung disease (ILD) is a leading cause of death in patients with systemic sclerosis (SSc). Nonspecific immunosuppressants have been the first-line treatment for SSc-associated ILD (SSc-ILD). Nintedanib, an oral triple kinase inhibitor targeting profibrotic pathways, has been employed for the treatment of idiopathic pulmonary fibrosis and has recently received marketing approval in the United States and Japan, based on the results of a placebo-controlled randomized controlled trial. In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo. AREAS COVERED This review covers current pharmacotherapies for SSc-ILD, drug profiles of nintedanib, and efficacy and safety profiles of nintedanib in patients with idiopathic pulmonary fibrosis and SSc-ILD observed in randomized controlled trails. EXPERT OPINION Currently, we have two treatment options for SSc-ILD, i.e., immunosuppressants and antifibrotic agents. However, appropriate utilization of antifibrotic agents in clinical practice remains challenging, i.e., in which cases they are to be used, timing of use, how to use them properly, and whether in combination with immunosuppressants.",2020,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo. ","['systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis (SSc', 'patients with idiopathic pulmonary fibrosis and SSc-ILD']","['Nintedanib', 'placebo']",[],"[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0547629,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo. ","[{'ForeName': 'Yoshioki', 'Initials': 'Y', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1777857'] 2088,32506992,"Changing Cognitive Risk Factors for Sexual Aggression: Risky Sexual Scripts, Low Sexual Self-Esteem, Perception of Pornography, and Acceptance of Sexual Coercion.","Sexual aggression is a problem among college students worldwide, and a growing body of research has identified variables associated with an increased risk of victimization and perpetration. Among these, sexuality-related cognitions, such as sexual scripts, sexual self-esteem, perceived realism of pornography, and acceptance of sexual coercion, play a major role. The current experimental study aimed to show that these cognitive risk factors of sexual aggression victimization and perpetration are amenable to change, which is a critical condition for evidence-based intervention efforts. College students in Germany ( N = 324) were randomly assigned to one of three groups: a treatment group designed to change participants' sexual scripts for consensual sex with regard to the role of alcohol consumption, casual sex, and ambiguous communication of sexual intentions as risk factors for sexual aggression (EG1), a treatment group designed to promote sexual self-esteem, challenge the perceived realism of pornography, and reduce the acceptance of sexual coercion (EG2), and a non-treatment control group (CG). Baseline (T1), post-experimental (T2), and follow-up (T3) measures were taken across an eight-week period. Sexual scripts contained fewer risk factors for sexual aggression in EG1 than in EG2 and CG at T3. Sexual self-esteem was enhanced in EG2 at T2 relative to the other two groups. Acceptance of sexual coercion was lower in EG2 than in EG1 and CG at T2 and T3. No effect was found for perceived realism of pornography. The findings are discussed in terms of targeting cognitive risk factors as a basis for intervention programs.",2020,Acceptance of sexual coercion was lower in EG2 than in EG1 and CG at T2 and T3.,['College students in Germany ( N = 324'],"[""treatment group designed to change participants' sexual scripts for consensual sex with regard to the role of alcohol consumption, casual sex, and ambiguous communication of sexual intentions as risk factors for sexual aggression (EG1), a treatment group designed to promote sexual self-esteem, challenge the perceived realism of pornography, and reduce the acceptance of sexual coercion (EG2), and a non-treatment control group (CG""]","['Acceptance of sexual coercion', 'Baseline (T1), post-experimental (T2), and follow-up (T3) measures', 'Sexual self-esteem']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0556472', 'cui_str': 'Casual sexual relationship'}, {'cui': 'C3539086', 'cui_str': 'Ambiguous'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032702', 'cui_str': 'Pornography'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",324.0,0.0159017,Acceptance of sexual coercion was lower in EG2 than in EG1 and CG at T2 and T3.,"[{'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Schuster', 'Affiliation': 'University of Potsdam, Germany.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Tomaszewska', 'Affiliation': 'University of Potsdam, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Krahé', 'Affiliation': 'University of Potsdam, Germany.'}]",Journal of interpersonal violence,['10.1177/0886260520922341'] 2089,32507027,Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke.,"Background and Purpose . Previous studies suggest that individuals poststroke can achieve substantial gains in walking function following high-intensity locomotor training (LT). Recent findings also indicate practice of variable stepping tasks targeting locomotor deficits can mitigate selected impairments underlying reduced walking speeds. The goal of this study was to investigate alterations in locomotor biomechanics following 3 different LT paradigms. Methods . This secondary analysis of a randomized trial recruited individuals 18 to 85 years old and >6 months poststroke. We compared changes in spatiotemporal, joint kinematics, and kinetics following up to 30 sessions of high-intensity (>70% heart rate reserve [HRR]) LT of variable tasks targeting paretic limb and balance impairments (high-variable, HV), high-intensity LT focused only on forward walking (high-forward, HF), or low-intensity LT (<40% HRR) of variable tasks (low-variable, LV). Sagittal spatiotemporal and joint kinematics, and concentric joint powers were compared between groups. Regressions and principal component analyses were conducted to evaluate relative contributions or importance of biomechanical changes to between and within groups. Results . Biomechanical data were available on 50 participants who could walk ≥0.1 m/s on a motorized treadmill. Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV. Resultant principal component analyses were characterized by paretic powers and kinematic consistency following HV, while HF and LV were characterized by nonparetic powers. Conclusion . High-intensity LT results in greater changes in kinematics and kinetics as compared with lower-intensity interventions. The results may suggest greater paretic-limb contributions with high-intensity variable stepping training that targets specific biomechanical deficits. Clinical Trial Registration . https://clinicaltrials.gov/ Unique Identifier: NCT02507466.",2020,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","['individuals 18 to 85 years old and >6 months poststroke', '50 participants who could walk ≥0.1 m/s on a motorized treadmill']","['high-intensity variable stepping training', 'High-Intensity Stepping Training', 'https://clinicaltrials.gov']","['locomotor biomechanics', 'Sagittal spatiotemporal and joint kinematics, and concentric joint powers', 'spatiotemporal parameters, kinematic consistency, and kinetics']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",50.0,0.0846158,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Gordhan', 'Initials': 'G', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connolly', 'Affiliation': 'University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320929675'] 2090,32507029,Effect of pineapple juice on the pharmacokinetics of celecoxib and montelukast in humans.,"Aim: To study the influence of pineapple juice on the pharmacokinetics of celecoxib and montelukast in humans. Experimental methods: The research comprised two separate arms. Each arm was randomized, two-crossover periods separated by a 2-week washout period. Subjects received a single dose of celecoxib or montelukast after pretreatment with either water or pineapple juice for 4 days before the study beginning. Results & conclusion: Pineapple juice enhanced the systemic exposure of both drugs without any noticeable adverse effects. For celecoxib, C max and AUC 0-∞ were increased significantly by 40 and 60%, respectively. Cl/F was decreased by 45% without affecting its t 1/2 . For montelukast, C max and AUC 0-∞ were significantly increased by 21 and 48%, respectively, along with 25% decrease in clearance and 13% increase in t 1/2 .",2020,"For montelukast, C max and AUC 0-∞ were significantly increased by 21 and 48%, respectively, along with 25% decrease in clearance and 13% increase in t 1/2 .",['humans'],"['celecoxib or montelukast', 'pineapple juice', 'celecoxib and montelukast']","['Cl/F', 'C max and AUC 0-∞', 'clearance']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0452459', 'cui_str': 'pineapple juice'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0757675,"For montelukast, C max and AUC 0-∞ were significantly increased by 21 and 48%, respectively, along with 25% decrease in clearance and 13% increase in t 1/2 .","[{'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Helmy', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'El-Bedaiwy', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}, {'ForeName': 'Soha M', 'Initials': 'SM', 'LastName': 'El-Masry', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}]",Therapeutic delivery,['10.4155/tde-2020-0020'] 2091,32507057,"Effect of a Spinomed orthosis on balance performance, spinal alignment, joint position sense and back muscle endurance in elderly people with hyperkyphotic posture: A randomized controlled trial.","BACKGROUND Hyperkyphosis may cause balance impairment in elderly people. Although the effectiveness of orthoses for improving balance in hyperkyphotic elderly people has received much attention, the mechanisms by which devices affect balance remain unknown. OBJECTIVES The objective of this study was to evaluate changes in balance performance, thoracic kyphosis angle, craniovertebral angle, back muscle endurance and joint position sense after 3 months of wearing a Spinomed orthosis. The study also included a secondary exploratory analysis to determine whether changes in any of the above-mentioned outcome measures can predict balance performance improvement in elderly people with hyperkyphosis. STUDY DESIGN Parallel group randomized controlled trial. METHODS In total, 44 hyperkyphotic elderly people were randomly allocated to an experimental group, who wore a Spinomed orthosis and a control group, who did not. No other treatment or change in physical activity was permitted during the study. A blinded assessor evaluated thoracic kyphosis angle, joint position sense, craniovertebral angle, back muscle endurance, Timed Up and Go Test time and Berg Balance Scale score at baseline and after 5, 9 and 13 weeks. All dependent variables were measured without the orthosis and analyzed separately using a 2 × 4 (time × group) mixed model analysis of variance. Based on the results of correlation analysis, thoracic kyphosis angle, back muscle endurance and joint position sense were selected as independent variables in a stepwise multiple regression model. RESULTS The two-way (group × time) interactions were significant in terms of Berg Balance Scale ( F  = 11.6, P  ⩽ 0.001, η p 2 = 0 . 59 ), Timed Up and Go Test ( F  = 3.74, P  = 0.013, η p 2 = 0 . 46 ), thoracic kyphosis angle ( F  = 43.39, P  ⩽ 0.001, η p 2 = 0 . 96 ), craniovertebral angle ( F  = 5.245, P  = 0.002, η p 2 = 0 . 59 ) and joint position sense ( F  = 4.44, P  = 0.005, [Formula: see text] ). The two-way interaction was not significant in terms of back muscle endurance; however, the main effect of group was significant for this variable ( F  = 3.85, P  = 0.025). Stepwise multiple regression showed that thoracic kyphosis angle and joint position sense were significant determinants of Timed Up and Go Test time ( R 2  = 0.155, P  = 0.037 and R 2  = 0.292, P  = 0.012, respectively). CONCLUSION Wearing a Spinomed orthosis for 3 months improved the posture, position sense and muscle performance of hyperkyphotic elderly people. Orthoses may improve balance performance by correcting spinal alignment and increasing proprioceptive information.",2020,"Stepwise multiple regression showed that thoracic kyphosis angle and joint position sense were significant determinants of Timed Up and Go Test time ( R 2  = 0.155, P  = 0.037 and R 2  = 0.292, P  = 0.012, respectively). ","['hyperkyphotic elderly people', '44 hyperkyphotic elderly people', 'elderly people', 'elderly people with hyperkyphotic posture', 'elderly people with hyperkyphosis']",['Spinomed orthosis'],"['thoracic kyphosis angle, back muscle endurance and joint position sense', 'Timed Up and Go Test', 'thoracic kyphosis angle and joint position sense', 'Timed Up and Go Test time', 'balance performance, spinal alignment, joint position sense and back muscle endurance', 'Berg Balance Scale', 'posture, position sense and muscle performance', 'balance performance, thoracic kyphosis angle, craniovertebral angle, back muscle endurance and joint position sense', 'balance performance', 'joint position sense', 'physical activity', 'craniovertebral angle', 'back muscle endurance', 'thoracic kyphosis angle', 'thoracic kyphosis angle, joint position sense, craniovertebral angle, back muscle endurance, Timed Up and Go Test time and Berg Balance Scale score']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}]","[{'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.10268,"Stepwise multiple regression showed that thoracic kyphosis angle and joint position sense were significant determinants of Timed Up and Go Test time ( R 2  = 0.155, P  = 0.037 and R 2  = 0.292, P  = 0.012, respectively). ","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hosseinabadi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kamyab', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Azadinia', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Sarrafzadeh', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",Prosthetics and orthotics international,['10.1177/0309364620923816'] 2092,32507103,Structural Relationship Study of Octanol-Water Partition Coefficient of Some Sulfa Drugs Using GA-MLR and GA-ANN Methods.,"AIM AND OBJECTIVE Sulfonamides (sulfa drugs) are compounds with a wide range of biological activities and they are the basis of several groups of drugs. Quantitative Structure-Property Relationship (QSPR) models are derived to predict the logarithm of water/ 1-octanol partition coefficients (logP) of sulfa drugs. MATERIALS AND METHODS A data set of 43 sulfa drugs was randomly divided into 3 groups: training, test and validation sets consisting of 70%, 15% and 15% of data point, respectively. A large number of molecular descriptors were calculated with Dragon software. The Genetic Algorithm - Multiple Linear Regressions (GA-MLR) and genetic algorithm -artificial neural network (GAANN) were employed to design the QSPR models. The possible molecular geometries of sulfa drugs were optimized at B3LYP/6-31G* level with Gaussian 98 software. The molecular descriptors derived from the Dragon software were used to build a predictive model for prediction logP of mentioned compounds. The Genetic Algorithm (GA) method was applied to select the most relevant molecular descriptors. RESULTS The R2 and MSE values of the MLR model were calculated to be 0.312 and 5.074 respectively. R2 coefficients were 0.9869, 0.9944 and 0.9601for the training, test and validation sets of the ANN model, respectively. CONCLUSION Comparison of the results revealed that the application the GA-ANN method gave better results than GA-MLR method.",2020,The molecular descriptors derived from the Dragon software were used to build a predictive model for prediction logP of mentioned compounds.,['43 sulfa drugs'],[],['R2 and MSE values of the MLR model'],"[{'cui': 'C0599503', 'cui_str': 'Sulfonamide antibiotic product'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023509', 'cui_str': 'Mixed lymphocyte reaction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",,0.0219194,The molecular descriptors derived from the Dragon software were used to build a predictive model for prediction logP of mentioned compounds.,"[{'ForeName': 'Etratsadat', 'Initials': 'E', 'LastName': 'Dadfar', 'Affiliation': 'Department of Chemistry, Arak Branch, Islamic Azad University, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shafiei', 'Affiliation': 'Department of Chemistry, Arak Branch, Islamic Azad University, Arak, Iran.'}, {'ForeName': 'Tahereh M', 'Initials': 'TM', 'LastName': 'Isfahani', 'Affiliation': 'Department of Chemistry, Arak Branch, Islamic Azad University, Arak, Iran.'}]",Current computer-aided drug design,['10.2174/1573409915666190301124714'] 2093,32507144,Osteopathic manipulative treatment combined with exercise improves pain and disability in individuals with non-specific chronic neck pain: A pragmatic randomized controlled trial.,"PURPOSE To determine effectiveness of osteopathic manipulative treatment combined with stretching and strengthening exercises in the cervical region on pain and disability in individuals with non-specific chronic neck pain. METHODS 90 adults with non-specific chronic neck pain were randomized to either exercises group (EG, n = 45) or osteopathic manipulative treatment associated with exercises group (OMT/EG, n = 45). The primary outcomes were obtained by the use of Numeric Pain-Rating Scale (NPRS), Pressure Pain Threshold (PPT) and Neck Disability Index (NDI). Secondary outcomes included range of motion (ROM) for cervical spine rotation, Fear-Avoidance Beliefs Questionnaire Work/Physical Activity (FABQ-W/PA) and Pain-self efficacy at two different moments: baseline and 4 weeks after the first treatment. Techniques and dosages of OMT were selected pragmatically by a registered osteopath. Generalized Estimating Equations model (GEE), complemented by the Least Significant Difference (LSD) and the intention-to-treat analysis, was used to assess the clinical outcomes. RESULTS Analysis with GEE indicated that OMT/EG reduced pain and disability more than the EG alone after 4 weeks of treatment with statistically significant difference (p < 0,05), as well as cervical active rotation was significantly improved (p = 0.03). There were no between-group differences observed in Pressure Pain Threshold (PPT) measure, Fear-Avoidance Beliefs Questionnaire and Pain-self efficacy. CONCLUSION The association between OMT and exercises reduces pain and improves functional disability more than only exercise for individuals with non-specific chronic neck pain.",2020,"There were no between-group differences observed in Pressure Pain Threshold (PPT) measure, Fear-Avoidance Beliefs Questionnaire and Pain-self efficacy. ","['individuals with non-specific chronic neck pain', '90 adults with non-specific chronic neck pain']","['OMT and exercises', 'osteopathic manipulative treatment combined with stretching and strengthening exercises', 'Osteopathic manipulative treatment combined with exercise', 'OMT', 'exercises group (EG, n\u202f=\u202f45) or osteopathic manipulative treatment associated with exercises group (OMT/EG, n\u202f=\u202f45']","['Numeric Pain-Rating Scale (NPRS), Pressure Pain Threshold (PPT) and Neck Disability Index (NDI', 'pain and disability', 'cervical active rotation', 'range of motion (ROM) for cervical spine rotation, Fear-Avoidance Beliefs Questionnaire Work/Physical Activity (FABQ-W/PA) and Pain-self efficacy', 'Pressure Pain Threshold (PPT) measure, Fear-Avoidance Beliefs Questionnaire and Pain-self efficacy', 'OMT/EG reduced pain and disability', 'functional disability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",90.0,0.103638,"There were no between-group differences observed in Pressure Pain Threshold (PPT) measure, Fear-Avoidance Beliefs Questionnaire and Pain-self efficacy. ","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Groisman', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Instituto Brasileiro de Osteopatia (IBO), Brazil. Electronic address: sandrogroisman@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Malysz', 'Affiliation': 'Graduate Program in Neuroscience, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Department of Morphological Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza da Silva', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rocha Ribeiro Sanches', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Camargo Bragante', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Franciele', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Cleder', 'Initials': 'C', 'LastName': 'Pontel Vigolo', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Vaccari', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Homercher Rosa Francisco', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Monteiro Steigleder', 'Affiliation': 'Instituto Brasileiro de Osteopatia (IBO), Brazil.'}, {'ForeName': 'Geraldo Pereira', 'Initials': 'GP', 'LastName': 'Jotz', 'Affiliation': 'Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Department of Morphological Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.11.002'] 2094,32507145,Evaluating the short term effects of kinesiology taping and stretching of gastrocnemius on postural control: A randomized clinical trial.,"INTRODUCTION The ability to maintain balance is essential for both remaining in the standing position and preventing falls. Physical therapy techniques such as kinesiology taping (KT) and stretching are considered to be effective measures in ameliorating balance issues. However, there is no available study comparing the effects of these two methods on postural control. Thus, the current study aims to investigate and compare the efficacy of interventions accomplished through these methods on young and elderly subjects. METHOD In a single-blind randomized clinical trial, 40 young subjects (<30 years) and 40 elderly subjects (>60 years) were randomly assigned to two groups of KT and stretching. In the first group, inhibitory tape was applied to the gastrocnemius muscle. In the second group, 60 s of stretch was repeated 4 times. The static balance was evaluated before and after the interventions using the single-leg standing (SLS) test along with measurements of the velocity and displacement of the center of pressure by the force plate. RESULTS Based on the Mann-Whitney test, there were no significant differences between the tape and stretching techniques in the study variables of either group of participants, before and after the interventions (p > 0.05). However, the results of the Wilcoxon test showed a significant increase in single-leg stance time in the stretching group in the elderly subjects (p = 0.03). MANOVA results demonstrated significant group and time effects only in the SLS parameter (p < 0.05). CONCLUSION Stretching the gastrocnemius seems to be more efficacious than KT for improving balance problems in older adults. LEVEL OF EVIDENCE II.",2020,"Based on the Mann-Whitney test, there were no significant differences between the tape and stretching techniques in the study variables of either group of participants, before and after the interventions (p > 0.05).","['young and elderly subjects', 'older adults', '40 young subjects (<30 years) and 40 elderly subjects (>60 years']","['KT and stretching', 'kinesiology taping and stretching of gastrocnemius', 'KT', 'Physical therapy techniques such as kinesiology taping (KT) and stretching']","['static balance', 'single-leg stance time']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.0179115,"Based on the Mann-Whitney test, there were no significant differences between the tape and stretching techniques in the study variables of either group of participants, before and after the interventions (p > 0.05).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Shafizadegan', 'Affiliation': 'Musculoskeletal Research Center, Department of Physiotherapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: z.shafizadegan@rehab.mui.ac.ir.'}, {'ForeName': 'Hamzeh', 'Initials': 'H', 'LastName': 'Baharlouei', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur Univesity of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Khoshavi', 'Affiliation': 'Musculoskeletal Research Center, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Garmabi', 'Affiliation': 'Student Research Committee, Rehabilitation School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Fereshtenejad', 'Affiliation': 'Musculoskeletal Research Center, Instructor at Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.11.003'] 2095,32507146,Adding Temporomandibular joint treatments to routine physiotherapy for patients with non-specific chronic neck pain: A randomized clinical study.,"INTRODUCTION Neck Pain can be related to the disorders of other adjacent areas such as the Temporomandibular Joint (TMJ). This study aimed to investigate whether there is value in adding TMJ treatments to routine physiotherapy in patients with non-specific chronic neck pain compared with a control group. METHODS A randomized, single-blind, clinical study desined including two groups of patients. Group A (20 people) received routine physiotherapy for neck pain and group B (20 people) received TMJ manual therapy plus exercise therapy in addition to routine physiotherapy for neck pain. The Treatment program included six sessions for two days a week over a period of 21 days. Assessments were performed during the first session, in the last session and one month after treatment as a follow-up. Outcome measures included neck range of motion (ROM), neck disability index (NDI) and visual analogue scale (VAS). Before starting the study, the reliability of methods for measuring neck ROM was evaluated. RESULTS Participants were 21 women and 19 men. Initially, a pilot study was carried out on the 40 volunteers to assess the reliability of the measurement methods, and the results were acceptable. With both the control group and the intervention group, the indexes showed significant improvement (p < 0.001), although the intervention group showed more improvement (p < 0.001). CONCLUSION This result means adding treatments of TMJ to routine neck physiotherapy can magnify the effect of the intervention, a significant change still in evidence at follow up. Moreover, given the clinically important differences, our results for VAS and NDI were acceptable.",2020,"With both the control group and the intervention group, the indexes showed significant improvement (p < 0.001), although the intervention group showed more improvement (p < 0.001). ","['Participants were 21 women and 19 men', 'patients with non-specific chronic neck pain', '40 volunteers', 'patients with non-specific chronic neck pain compared with a control group', 'two groups of patients']","['TMJ', 'routine physiotherapy', 'TMJ manual therapy plus exercise therapy', 'Temporomandibular joint treatments', 'routine physiotherapy for neck pain']","['neck range of motion (ROM), neck disability index (NDI) and visual analogue scale (VAS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C1319209', 'cui_str': 'Neck joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",21.0,0.0405683,"With both the control group and the intervention group, the indexes showed significant improvement (p < 0.001), although the intervention group showed more improvement (p < 0.001). ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghodrati', 'Affiliation': 'Health and Rehabilitation Sciences Program, University of Western Ontario, London, Canada.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physical Therapy and Research Center of Aging, University of Social Welfare and Rehabilitation Sciences (USWR), Tehran, Iran. Electronic address: zmosallanezhad@yahoo.com.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Shati', 'Affiliation': 'Mental Health Research Center, School of Behavioral Sciences and Mental Health, Tehran Institute of Psychiatry, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Noroozi', 'Affiliation': 'Psychosis Research Center, University of Social Welfare and Rehabilitation Sciences (USWR), Tehran, Iran.'}, {'ForeName': 'Afsun Nodehi', 'Initials': 'AN', 'LastName': 'Moghadam', 'Affiliation': 'Department of Physical Therapy and Research Center of Aging, University of Social Welfare and Rehabilitation Sciences (USWR), Tehran, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Department of Physical Therapy and Research Center of Aging, University of Social Welfare and Rehabilitation Sciences (USWR), Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Physical Therapy, University of the North Georgia, GA, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.11.004'] 2096,32507149,Acute effects of whole-body vibration on spinal excitability level and ankle plantar flexion spasticity in post-stroke individuals: A randomized controlled trial.,"INTRODUCTION This study aimed to evaluate the acute effects (up to 30 min) of whole-body vibration (WBV) on spinal excitability level and ankle plantar flexion spasticity in chronic stroke subjects. METHODS Twenty-one subjects (age 30-70 years old) with chronic stroke and ankle plantar flexion spasticity were randomly assigned to the vibration group (VG, n = 11) or the control group (CG, n = 10). Subjects in the VG underwent 10 minutes of WBV with a frequency of 35 Hz and amplitude of 2 mm. Subjects in the CG remained on the platform for 10 min without receiving vibratory stimulus. The spinal excitability level was estimated by the Hmax/Mmax ratio extracted from the H-reflex with simple stimulus examination. The value of the second/first wave ratio (H2/H1 ratio) at the peak of the first facilitation was also considered through the recovery curve with double stimulation. Spasticity was estimated by the Modified Ashworth Scale (MAS) and global perception of change. All outcomes were assessed before and at 10, 20, and 30 min after the WBV, except for MAS, which was evaluated only 10 min after WBV. RESULTS No between-group differences were found in either the spinal excitability level or plantar flexor spasticity at the three evaluated moments after WBV. CONCLUSION These results suggest that WBV does not reduce spinal excitability level or spasticity of the plantar flexor muscles in chronic stroke patients in the first 30 min after vibratory stimulus.",2020,"No between-group differences were found in either the spinal excitability level or plantar flexor spasticity at the three evaluated moments after WBV. ","['post-stroke individuals', 'Twenty-one subjects (age 30-70 years old) with chronic stroke and ankle plantar flexion spasticity', 'chronic stroke subjects']","['whole-body vibration', 'vibration group (VG, n\u202f=\u202f11) or the control group (CG', 'WBV', 'whole-body vibration (WBV']","['spinal excitability level or spasticity of the plantar flexor muscles', 'spinal excitability level and ankle plantar flexion spasticity', 'Spasticity', 'spinal excitability level or plantar flexor spasticity', 'spinal excitability level', 'Modified Ashworth Scale (MAS) and global perception of change']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0236033,"No between-group differences were found in either the spinal excitability level or plantar flexor spasticity at the three evaluated moments after WBV. ","[{'ForeName': 'Rafael Moreira', 'Initials': 'RM', 'LastName': 'Sales', 'Affiliation': 'Department of Physical Therapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Mikhail Santos', 'Initials': 'MS', 'LastName': 'Cerqueira', 'Affiliation': 'Department of Physical Therapy, Federal University of Pernambuco, Recife, Brazil. Electronic address: mikalsantosc@hotmail.com.'}, {'ForeName': 'André Terácio', 'Initials': 'AT', 'LastName': 'Bezerra de Morais', 'Affiliation': 'Department of Physical Therapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Claúdia Regina O', 'Initials': 'CRO', 'LastName': 'de Paiva Lima', 'Affiliation': 'Department of Statistics, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lemos', 'Affiliation': 'Department of Physical Therapy, Federal University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galvão de Moura Filho', 'Affiliation': 'Department of Physical Therapy, Federal University of Pernambuco, Recife, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.018'] 2097,32510741,Effectiveness of postpartum sexual health education programme structured according to Levine's conservation model: An interventional study.,"AIM This study aimed to determine the effects of a postpartum sexual health education programme structured according to Levine's conservation model on postpartum women. METHODS The interventional study was completed with 67 postpartum women. The intervention group was given the postpartum sexual health education programme structured according to Levine's conservation model. The control group received routine discharge training. The data were collected using a personal information form, The Index of Female Sexual Function, Arizona Sexual Experience Scale and Golombok-Rust Inventory of Sexual Satisfaction. RESULTS It has been determined that the decrease in sexual arousal and desire is the first among postpartum sexual problems experienced by women. This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters. After the programme, the intervention group had more adequate sexual function, and they developed a strong, easy and satisfactory sexual response than the control group (p < 0.05). CONCLUSION This programme was effective in increasing the sexual functions and satisfaction of the postpartum women. Models provide guidance to nurses for provision of care in a systematic manner.",2020,"This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters.","['nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters', 'postpartum women', '67 postpartum women']","['routine discharge training', 'postpartum sexual health education programme', ""postpartum sexual health education programme structured according to Levine's conservation model""]","['sexual function, sexual satisfaction and sexual response', 'adequate sexual function', 'sexual functions and satisfaction', 'Index of Female Sexual Function, Arizona Sexual Experience Scale and Golombok-Rust Inventory of Sexual Satisfaction', 'sexual arousal and desire', 'satisfactory sexual response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0319862', 'cui_str': 'Order Uredinales'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}]",67.0,0.019486,"This study demonstrated that sexual function, sexual satisfaction and sexual response were higher in nonbreastfeeding women, women who had sexual intercourse one to three times a week and women who could talk to health care professionals on sexual matters.","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Evcili', 'Affiliation': 'Vocational School of Health Care Services, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Gulbahtiyar', 'Initials': 'G', 'LastName': 'Demirel', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Bekar', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Guler', 'Affiliation': 'Faculty of Health Sciences, Midwifery Department, Cumhuriyet University, Sivas, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12855'] 2098,32510754,Effect of Nigella sativa oil supplement on risk factors for cardiovascular diseases in patients with type 2 diabetes mellitus.,"This study aimed to evaluate the effects of Nigella sativa oil on serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile in patients with type 2 diabetes mellitus (T2DM). This double-blind randomized clinical trial study was based on 50 patients with T2DM. Patients were allocated randomly to either N. sativa oil or placebo groups. The intervention group received 1,000 mg N. sativa oil as two capsules, daily for 8 weeks, whereas the placebo group received a corresponding placebo. At baseline and the end of the study, 5 ml blood was collected from each patient after 14-hour fasting for measuring serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile. Analyses covariance was performed to compare investigated parameters between two groups, controlled for relevant covariates. Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group. Nigella sativa oil supplement has cardiovascular protective effects in patients with T2DM, by improving the lipid profile and glycemia, by reducing the C-reactive protein level and the lipid peroxidation.",2020,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","['patients with T2DM', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM', '50 patients with T2DM']","['1,000\u2009mg N. sativa oil', 'Nigella sativa oil', 'Nigella sativa oil supplement', 'sativa oil or placebo', 'placebo']","['total cholesterol', 'serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile', 'low-density lipoprotein cholesterol', 'serum hs-CRP, MDA', 'triglyceride', 'serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile', 'cardiovascular protective effects', 'FBS', 'serum level of high-density lipoprotein cholesterol', 'risk factors for cardiovascular diseases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",50.0,0.281672,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Nutrition & Biochemistry, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Tofighiyan', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rastgoo', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Rakhshani', 'Affiliation': 'Iranian Research Center on Healthy Aging, Department of Biostatistics and Epidemiology, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Miri', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Environmental Health, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6707'] 2099,32505171,The effect of 1% glucose loading on metabolism in the elderly patients during remifentanil-induced anesthesia: a randomized controlled trial.,"BACKGROUND Previous studies showed that remifentanil-induced anesthesia can inhibit surgical stress response in non-diabetic adult patients and that low-dose glucose loading during anesthesia may attenuate fat catabolism. However, little is known about the influence of glucose loading on metabolism in elderly patients, whose condition may be influenced by decreased basal metabolism and increased insulin resistance. We hypothesized that, in elderly patients, intraoperative low glucose infusion may attenuate the catabolism of fat without causing harmful hyperglycemia during remifentanil-induced anesthesia. METHODS Elderly, non-diabetic patients scheduled to undergo elective surgery were enrolled and randomized to receive no glucose (0G group) or low-dose glucose infusion (0.1 g/kg/hr. for 1 h followed by 0.05 g/kg/hr. for 1 h; LG group) during surgery. Glucose, adrenocorticotropic hormone (ACTH), 3-methylhistidine (3-MH), insulin, cortisol, free fatty acid (FFA), creatinine (Cr), and ketone body levels were measured pre-anesthesia, 1 h post-glucose infusion, at the end of surgery, and on the following morning. RESULTS A total of 31 patients (aged 75-85) were included (0G, n = 16; LG, n = 15). ACTH levels during anesthesia decreased significantly in both groups. In the LG group, glucose levels increased significantly after glucose loading but hyperglycemia was not observed. During surgery, ketone bodies and FFA were significantly lower in the LG group than the 0G group. There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups. CONCLUSION Remifentanil-induced anesthesia inhibited surgical stress response in elderly patients. Intraoperative low-dose glucose infusion attenuated catabolism of fat without inducing hyperglycemia. TRIAL REGISTRATION This study has been registered with the University hospital Medical Information Network Center (http://www.umin.ac.jp/english/). TRIAL REGISTRATION NUMBER UMIN000016189. The initial registration date: January 12th 2015.",2020,"There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups. ","['31 patients (aged 75-85', 'elderly patients during remifentanil-induced anesthesia', 'Elderly, non-diabetic patients scheduled to undergo elective surgery', 'elderly patients', 'non-diabetic adult patients']","['Remifentanil-induced anesthesia', 'remifentanil-induced anesthesia', 'no glucose (0G group) or low-dose glucose infusion', 'glucose loading']","['Glucose, adrenocorticotropic hormone (ACTH), 3-methylhistidine (3-MH), insulin, cortisol, free fatty acid (FFA), creatinine (Cr), and ketone body levels', 'insulin, Cr, 3-MH, and 3-MH/Cr', 'glucose levels', 'ACTH levels during anesthesia', 'surgical stress response', 'hyperglycemia', 'ketone bodies and FFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0047600', 'cui_str': '3-methyl histidine'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",31.0,0.0680124,"There were no significant differences in insulin, Cr, 3-MH, and 3-MH/Cr between the two groups. ","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Fukuta', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan. kouhei_f_1983@yahoo.co.jp.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Kasai', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Niki', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Kakuta', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Sakai', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi Minami, Hiroshima, 774-8551, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8503, Japan.'}]",BMC anesthesiology,['10.1186/s12871-020-01061-3'] 2100,32505177,Effects of dexmedetomidine on stress hormones in patients undergoing cardiac valve replacement: a randomized controlled trial.,"BACKGROUND Stress response always occurs in cardiac valve replacement patients undergoing cardiopulmonary bypass (CPB). METHODS 60 patients undergoing cardiac valve replacement were recruited and randomized into control and Dex groups. Dex group received 1.0 μg·kg-1 of Dex for 10 min intravenously before anesthesia, followed by 0.5 μg·kg-1·h-1 of Dex, steadily administered throughout the procedure. And controlled group received the identical velocity of saline as Dex group. Plasma level of cortisol (Cor), epinephrine (E), norepinephrine (NE), and serotonin (5-HT) were evaluated at four timepoints: Before administration (T0), sawn sternum (T1), end of extracorporeal circulation (T2), and 24 h post operation (T3). General data of operation and recovery such as heart rate (HR), mean arterial pressure (MAP), intraoperative bispectral index (BIS), and hospitalization time in the intensive care unit (ICU) were also compared. RESULTS Increase of Cor, E, NE, and 5-HT for the Dex group was significant lesser than that in the control group (P < 0.05), and ICU hospitalization time and ventilator support time was significantly shorter in the Dex group. The proportion of patients discharged from the hospital with better prognosis was significantly higher than that in the control group, while there were no significant differences in hospitalization costs and vasoactive drugs use between the two groups. CONCLUSIONS Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement. TRIAL REGISTRATION China Clinical Trial Registry (No. ChiCTR-IPR-17010954) March 22rd, 2017.",2020,"Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement. ","['cardiac valve replacement patients undergoing cardiopulmonary bypass (CPB', 'patients undergoing cardiac valve replacement', '60 patients undergoing cardiac valve replacement']","['1.0\u2009μg·kg-1 of Dex', 'dexmedetomidine', 'Dex']","['heart rate (HR), mean arterial pressure (MAP), intraoperative bispectral index (BIS), and hospitalization time in the intensive care unit (ICU', 'Cor, E, NE, and 5-HT', 'proportion of patients discharged from the hospital with better prognosis', 'ICU hospitalization time and ventilator support time', 'Plasma level of cortisol (Cor), epinephrine (E), norepinephrine (NE), and serotonin (5-HT', 'hospitalization costs and vasoactive drugs use', 'plasma Cor, E and NE elevations', 'stress hormones']","[{'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",60.0,0.070869,"Dex reduces plasma Cor, E and NE elevations in patients after CPB, alleviates the stress reaction of the body, shortens the hospitalization time and ventilator support time in ICU, and plays a positive role in the rehabilitation of patients undergoing cardiac valve replacement. ","[{'ForeName': 'Hanhua', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Jinqing', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, Third Affiliated Hospital of Zunyi Medical University, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Jiamei', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, No. 149 Dalian Road, Huichuan District, Zunyi, 563003, Guizhou Province, China. zhzmcc@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-00993-0'] 2101,32505436,Specific model for the coordination of primary and hospital care for patients with diabetes mellitus. Evaluation of two-year results (2015-2017).,"INTRODUCTION Diabetes mellitus (DM) is one of the most prevalent chronic diseases and has a significant health and social impact. Strict control of blood glucose levels and other risk factors for vascular disease reduces complications and mortality and is related to the quality of care received. Although care should be interdisciplinary, based on the coordination of primary care (PC) and hospital care (HC), little information is available on the effectiveness of the different existing intervention models. OBJECTIVE To assess, in a population with DM from a healthcare area, the impact on health, quality of care, and effectiveness in the use of resources of a specific model of shared management of patients with DM (Instrument for Evaluation of Models of Chronic Care in Diabetes Mellitus; IEMAC-DM). PATIENTS AND METHODS A quasi-experimental before-after intervention study in patients with DM in the Cádiz-San Fernando Healthcare Area (Andalusia, Spain) that allows for identifying the capacity of the program to improve the quality indicators both in the whole population with DM and in that referred to HC. For this, a working group consisting of healthcare professionals of different profiles and care levels was set up. An initial self-assessment was done using the IEMAC-DM tool and, after analysis of the preliminary results, improvement strategies were established and implemented. Finally, the clinical and resource management results were assessed before and two years after the implementation of the model. RESULTS During the study period, no significant changes were seen in process indicators related to laboratory practices or examinations in the health area. The proportion of patients with acceptable metabolic control [glycosylated hemoglobin (HbA1c) level<8%] was 49% in 2015 and 45% in 2017. The number of admissions related to acute myocardial infarction and stroke remained constant, but there was an increase in the standardized ratio of major lower limb amputations (1.5 vs. 1.9). Of the 295 patients referred from PC to HC, the proportion of adequate referrals increased from 40% in 2015 to 76% in 2017 (p=0.001). In the referred patients, a significant improvement was seen in the mean difference in glycosylated hemoglobin levels (HbA1c; 1.14±1.73%; 95% CI: 0.73-1.55; p=0.0001) and cholesterol (11.28±40mg/dL; 95% CI: 2.07-20.48; p=0.012). CONCLUSIONS This study shows that an intervention based on a chronicity care model adapted to patients with DM improves certain aspects related to the quality of care and the degree of metabolic control. Improving health outcomes will require long-term evaluation and, probably, other additional interventions.",2020,"During the study period, no significant changes were seen in process indicators related to laboratory practices or examinations in the health area.","['A quasi-experimental before-after intervention study in patients with DM in the Cádiz-San Fernando Healthcare Area (Andalusia, Spain', 'patients with diabetes mellitus', 'patients with DM (Instrument for Evaluation of Models of Chronic Care in Diabetes Mellitus; IEMAC-DM']",[],"['standardized ratio of major lower limb amputations', 'number of admissions related to acute myocardial infarction and stroke remained constant', 'cholesterol', 'proportion of adequate referrals', 'glycosylated hemoglobin levels']","[{'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",[],"[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0574846', 'cui_str': 'Number of admissions'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",295.0,0.0324473,"During the study period, no significant changes were seen in process indicators related to laboratory practices or examinations in the health area.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mateo-Gavira', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Instituto de Investigación e Innovación Biomédica de Cádiz (INIBICA). Hospital Universitario Puerta del Mar, Cádiz, España.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Carrasco-García', 'Affiliation': 'Departamento de Medicina, Facultad de Medicina, Universidad de Cádiz, Cádiz, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Larran', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Instituto de Investigación e Innovación Biomédica de Cádiz (INIBICA). Hospital Universitario Puerta del Mar, Cádiz, España.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Fierro', 'Affiliation': 'Centro de Salud del Olivillo, Cádiz, España.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Zarallo', 'Affiliation': 'Centro de Salud Dr. Cayetano Roldán, San Fernando, Cádiz, España.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mayoral Sánchez', 'Affiliation': 'Plan Integral de Diabetes Mellitus de Andalucía, Consejería de Salud, Sevilla, España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Aguilar-Diosdado', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Instituto de Investigación e Innovación Biomédica de Cádiz (INIBICA). Hospital Universitario Puerta del Mar, Cádiz, España; Departamento de Medicina, Facultad de Medicina, Universidad de Cádiz, Cádiz, España. Electronic address: manuel.aguilar.sspa@juntadeandalucia.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.12.010'] 2102,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177'] 2103,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial Alternating Current Stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 minutes) for the active stimulation and 30 seconds for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: nemeth@nemethlab.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733'] 2104,32505701,Effect of Parent Training on Health-Related Quality of Life in Preschool Children With Attention-Deficit/Hyperactivity Disorder: A Secondary Analysis of Data From a Randomized Controlled Trial.,"OBJECTIVE School-aged children with attention-deficit/hyperactivity disorder (ADHD) have reduced health related quality of life (HRQoL) but it is unclear whether this also applies to preschool children. It is unknown whether parent training (PT) improves HRQoL. This study compared HRQoL in preschool children with ADHD with age-matched children from the general population, examined whether PT improves HRQoL, and tested if treatment-related changes in HRQoL are mediated by improvements in ADHD, parent efficacy (PE) and family stress (FS). METHOD Parents of 164 children, aged 3-7 years diagnosed with ADHD, participated in a randomized controlled trial, comparing the New Forest Parenting Programme (NFPP) and Treatment As Usual (TAU). Measures of HRQoL, ADHD, PE and FS were completed at baseline (T1), post treatment (T2) and 36 weeks follow-up (T3). Child baseline HRQoL was compared with two general population-based reference groups. PT effects were analyzed using linear models and mediation analyses. RESULTS Preschoolers with ADHD had lower HRQoL than the reference groups. NFPP, but not TAU, was associated with improvement in the psychosocial HRQoL at T2 (2.28, 95% CI [0.78; 3.77]) and at T3 (2.05, 95% CI [0.56; 3.54]). This difference between treatment arms was not statistically significant. PE and FS scores at T2 significantly mediated improvements in HRQoL at T3. ADHD scores at T2 did not. CONCLUSION ADHD negatively impacts HRQoL in early childhood. PT for ADHD has the potential to improve HRQoL independently of its effects on ADHD symptoms.",2020,"NFPP, but not TAU, was associated with improvement in the psychosocial HRQoL at T2 (2.28, 95% CI [0.78; 3.77]) and at T3 (2.05, 95% CI [0.56; 3.54]).","['With Attention-Deficit/Hyperactivity Disorder', 'Preschool Children', 'School-aged children with attention-deficit/hyperactivity disorder (ADHD', 'Parents of 164 children, aged 3-7 years diagnosed with ADHD', 'Preschoolers with ADHD', 'preschool children with ADHD with age-matched children from the general population']","['Parent Training', 'New Forest Parenting Programme (NFPP) and Treatment', 'HRQoL', 'parent training (PT']","['psychosocial HRQoL', 'ADHD scores', 'HRQoL', 'PE and FS scores', 'Health-Related Quality of Life', 'PT effects', 'HRQoL, ADHD, PE and FS', 'efficacy (PE) and family stress (FS']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0577730', 'cui_str': 'Family tension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",164.0,0.325556,"NFPP, but not TAU, was associated with improvement in the psychosocial HRQoL at T2 (2.28, 95% CI [0.78; 3.77]) and at T3 (2.05, 95% CI [0.56; 3.54]).","[{'ForeName': 'Liva Bundgaard', 'Initials': 'LB', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Daley', 'Affiliation': ''}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Sonuga-Barke', 'Affiliation': ''}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': ''}, {'ForeName': 'Charlotte Ulrikka', 'Initials': 'CU', 'LastName': 'Rask', 'Affiliation': ''}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.04.014'] 2105,32505861,The affect of goserelin on the QoL of women having chemotherapy for EBC: Results from the OPTION trial.,"BACKGROUND The OPTION trial results showed that premenopausal women with early stage breast cancer (EBC) receiving chemotherapy benefited from ovarian function protection with goserelin. The impact of treatments on patient reported Quality of Life (QoL) were also examined. PATIENTS AND METHODS 227 pre-menopausal women with EBC, were randomly assigned to chemotherapy±goserelin (C±G); 132 (58%) were ER-ve. Patients were stratified by age (≤40 years and >40 years). QoL was assessed with the Functional Assessment of Cancer Therapy - Breast, and Endocrine Symptom checklist at baseline (pre-treatment), 3, 6, 12, 18 and 24 months, then annually to 5 years. Treatment Outcome Index (TOI) score was the primary outcome. RESULTS 213 patients were available for QoL analysis. There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time. The C + G group experienced higher levels of vasomotor symptoms generally during the treatment phase; by 24 months, the short-term negative effect of goserelin was reversed, with hot flushes twice as frequent in the chemotherapy only group (40.9% vs 21.3%). CONCLUSIONS These results show that young women diagnosed with breast cancer experienced only a short-term decrease in QoL from the addition of goserelin, in order to preserve ovarian function during chemotherapy treatment.",2020,"There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time.","['213 patients were available for QoL analysis', 'Patients were stratified by age (≤40 years and >40 years', 'women having chemotherapy for EBC', '227 pre-menopausal women with EBC', 'young women diagnosed with breast cancer', 'premenopausal women with early stage breast cancer (EBC) receiving']","['chemotherapy', 'chemotherapy±goserelin (C±G', 'goserelin']","['Functional Assessment of Cancer Therapy - Breast, and Endocrine Symptom checklist', 'Quality of Life (QoL', 'ovarian function', 'vasomotor symptoms', 'TOI scores', 'Treatment Outcome Index (TOI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",213.0,0.103562,"There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time.","[{'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'R', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Yellowlees', 'Initials': 'Y', 'LastName': 'A', 'Affiliation': 'Quantics Consulting Ltd, Edinburgh, United Kingdom.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'J', 'Affiliation': ""Department of Oncology, Guy's and St Thomas' NHS Foundation Hospital, London, United Kingdom.""}, {'ForeName': 'Fallowfield', 'Initials': 'F', 'LastName': 'L', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE -C) University of Sussex, United Kingdom.'}, {'ForeName': 'Jenkins', 'Initials': 'J', 'LastName': 'V', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE -C) University of Sussex, United Kingdom. Electronic address: val@sussex.ac.uk.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.05.009'] 2106,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007'] 2107,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Trenité', 'Initials': 'T', 'LastName': 'Dorothée Kasteleijn-Nolst', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377'] 2108,32507132,Whole body vibration improves symptoms of diabetic peripheral neuropathy.,"Whole Body Vibration (WBV) is an innovative therapy that may be effective for reducing chronic pain associated with diabetic peripheral neuropathy (DPN), Current treatments for DPN pain have demonstrated questionable efficacy and significant risk of adverse events. Preliminary research has indicated that WBV may be effective for controlling chronic pain symptoms of DPN. METHODS 20 participants (9 male, 11 female), 58.51 ± 10.69 years old, and BMI of 33.60 ± 8.20 kg/m2 were randomly assigned to a sham-treatment (n = 8) or WBV treatment (n = 12) group in a pre-post design. Pain was assessed with a 10-point verbal analog pain scale (VAS). Treatment consisted of three sessions/week with at least one day between sessions, 12 min/session (four bouts of 3 min), for four weeks. Control was established with a sham vibration protocol for two weeks in which the participants were blinded to the treatment. RESULTS VAS scores of the treatment group decreased significantly at both 2 and 4 weeks (p = 0.019). The treatment group was found to have a significantly lower VAS score than the controls at two weeks (p = 0.033). After cessation of WBV vibration treatment, participants reported reduced DPN-related pain from 1 to 5 weeks later. CONCLUSION WBV is effective for reducing DPN-associated pain over a two- and four-week interval. This was the first study to demonstrate this using a sham vibration control. We further saw a persistence in pain reduction beyond the day of treatment, indicating a potential chronic effect of WBV treatment.",2020,"RESULTS VAS scores of the treatment group decreased significantly at both 2 and 4 weeks (p = 0.019).","[' 58.51\xa0±\xa010.69 years old, and BMI of 33.60\xa0±\xa08.20\xa0kg/m2', '20 participants (9 male, 11 female']","['Whole body vibration', 'sham-treatment (n\xa0=\xa08) or WBV treatment', 'WBV vibration', 'Whole Body Vibration (WBV']","['reduced DPN-related pain', 'VAS score', 'pain reduction', '10-point verbal analog pain scale (VAS', 'Pain', 'DPN-associated pain', 'VAS scores']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0002777', 'cui_str': 'Analog Pain Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",20.0,0.0384436,"RESULTS VAS scores of the treatment group decreased significantly at both 2 and 4 weeks (p = 0.019).","[{'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Kessler', 'Affiliation': 'Department of Exercise and Health Science, Willamette University, USA; Western University of the Health Sciences COMP-NW, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Lockard', 'Affiliation': 'Department of Exercise and Health Science, Willamette University, USA. Electronic address: mlockard@willamette.edu.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Fischer', 'Affiliation': 'Western University of the Health Sciences COMP-NW, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.004'] 2109,32507135,Effect of Pilates Method on muscular trunk endurance and hamstring extensibility in adolescents during twelve weeks training and detraining.,"BACKGROUND Thoracic hyperkyphosis and lumbar hyperlordosis have been associated with low values of flexibility in the hamstring muscle and endurance of the trunk musculature. These are areas that are worked using the Pilates Method (PM), however, there are only two studies that assess its effect on these variables in adolescence, and none that measure the retention time of the acquired improvements. The main objective of this research was to assess the effect of 10 min of adapted exercise program from PM in a Physical Education class (PE) for 12 weeks, on trunk muscle endurance and hamstring flexibility, and to evaluate the retention of resulting changes. METHODS The sample consisted of 441 adolescents (age = 13.9 ± 1.3 years). The experimental group (EG) performed two weekly 10-min sessions of PM for 12 weeks. The control group (CG) performed its usual sessions of PE. The endurance of the trunk flexor muscles and trunk extensor muscles, toe touch test (TT), bench trunk curl test (BTC) and the Biering-Sörensen test (SOR), were used to evaluate hamstring flexibility, before application of the program, at the end, 12 weeks later. RESULTS A significant improvement was found in the EG for all variables analyzed, with an average improvement of 9.37 repetitions in the BTC test, 19.4 s in the SOR test and 2.75 in the TT test. The CG did not show significant changes. The EG's improvements were retained 12 weeks later, except in the SOR test. CONCLUSION The inclusion of 10 min of adapted exercise program from PM in PE classes, for two weekly sessions over 12 weeks, produces improvements in trunk muscle endurance and hamstring flexibility, and these gains are retained in the flexor and hamstring muscles 12 weeks later.",2020,"A significant improvement was found in the EG for all variables analyzed, with an average improvement of 9.37 repetitions in the BTC test, 19.4 s in the SOR test and 2.75 in the TT test.","['441 adolescents (age\xa0=\xa013.9\xa0±\xa01.3 years', 'adolescents during twelve weeks training and detraining']","['10\xa0min of adapted exercise program', 'control group (CG) performed its usual sessions of PE', 'Pilates Method']","['trunk muscle endurance and hamstring flexibility', 'endurance of the trunk flexor muscles and trunk extensor muscles, toe touch test (TT), bench trunk curl test (BTC) and the Biering-Sörensen test (SOR', 'muscular trunk endurance and hamstring extensibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",441.0,0.0226033,"A significant improvement was found in the EG for all variables analyzed, with an average improvement of 9.37 repetitions in the BTC test, 19.4 s in the SOR test and 2.75 in the TT test.","[{'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'González-Gálvez', 'Affiliation': 'Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vaquero-Cristóbal', 'Affiliation': 'Catholic University San Antonio of Murcia (UCAM), Murcia, Spain.'}, {'ForeName': 'Pablo Jorge', 'Initials': 'PJ', 'LastName': 'Marcos-Pardo', 'Affiliation': 'Catholic University San Antonio of Murcia (UCAM), Murcia, Spain. Electronic address: pmarcos@ucam.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.002'] 2110,32507136,Effects of the Russian current in the treatment of low back pain in women: A randomized clinical trial.,"BACKGROUND Low back pain (LBP) is a high impact condition that affects the working population, generating social and economic repercussions, the most relevant symptoms being pain and functional disability. Conservative treatment is often based on stabilizing spinal muscles with exercises: the Russian current (RC) is reported as an alternative, because it promotes muscle contraction, providing muscle strengthening and hypertrophy. OBJECTIVE To assess the effectiveness of the RC in aiding the treatment of low back pain. METHODS This randomized study included 23 women aged 18-30 years, divided into two groups: the control group (CG) and the Russian current group (RCG), for four weeks. Pain (visual analogue scale, VAS; pressure algometer, PA), function (Oswestry Low Back Disability Index), resistance (trunk resistance [TR] test) and thickness changes in the muscle (ultrasound image) were evaluated before and after the RC protocol and at one-month follow-up. RESULTS There were significant VAS reductions in both groups, but at follow-up these had only been maintained in the RCG, which presented lower values than the CG in the second evaluation. For PA, Oswestry and TR, there were differences only in the RCG. In a comparison of LBP between the groups, the initial difference disappeared in subsequent evaluations; TR presented higher values in evaluation 2 and 3 in the RCG group. In terms of thickness changes, differences between the groups were reduced after treatment. CONCLUSION The proposed treatment was effective in the reduction of LBP, with short-term improvement in resistance and thickness changes of the multifidus.",2020,"There were significant VAS reductions in both groups, but at follow-up these had only been maintained in the RCG, which presented lower values than the CG in the second evaluation.","['23 women aged 18-30 years', 'low back pain in women']","['control group (CG) and the Russian current group (RCG', 'Russian current']","['Pain (visual analogue scale, VAS; pressure algometer, PA), function (Oswestry Low Back Disability Index), resistance (trunk resistance [TR] test) and thickness changes in the muscle (ultrasound image', 'VAS reductions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",23.0,0.0336222,"There were significant VAS reductions in both groups, but at follow-up these had only been maintained in the RCG, which presented lower values than the CG in the second evaluation.","[{'ForeName': 'Carla Elis', 'Initials': 'CE', 'LastName': 'Batistella', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: c-arlaeli-s@hotmail.com.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Bidin', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: fernandabidin@hotmail.com.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Giacomelli', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: isabela.giacomelli1997@gmail.com.'}, {'ForeName': 'Milena Aparecida', 'Initials': 'MA', 'LastName': 'Nunez', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: milenaapnunez@gmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gasoto', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: eduardo_gmoreira@outlook.com.'}, {'ForeName': 'Carlos Eduardo de', 'Initials': 'CE', 'LastName': 'Albuquerque', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: ceafit@yahoo.com.'}, {'ForeName': 'Lucinar Jupir Forner', 'Initials': 'LJF', 'LastName': 'Flores', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: lucinar05@gmail.com.'}, {'ForeName': 'Gladson Ricardo Flor', 'Initials': 'GRF', 'LastName': 'Bertolini', 'Affiliation': 'Universidade Estadual Do Oeste Do Paraná - UNIOESTE, Universitaria St. 2069, Cascavel, Paraná, 85819-110, Brazil. Electronic address: gladson.bertolini@unioeste.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.10.009'] 2111,32507151,Contract-relax technique compared to static stretching in treating migraine in women: A randomized pilot trial.,"INTRODUCTION Physical therapy is often used by patients with headache, including modalities such as muscle stretching exercises. OBJECTIVES To evaluate the feasibility of a pilot trial aimed at determining the efficacy of the proprioceptive neuromuscular facilitation (PNF) contract-relax technique compared to static stretching for treating migraineurs. METHODS This pilot trial allocated 30 migraineur women (23 ± 4 years) into PNF (n = 15) and static stretching groups (n = 15). The interventions were performed twice a week (16 sessions, 8 weeks). The feasibility outcomes included successful random allocation of 30 patients during a 12-month period, the proportion of eligible patients randomly assigned to each group, and the proportion of those who completed the 30-day follow-up. The outcomes of headache characteristics; medication intake; severity of migraine-related disability; neck disability; cervical mobility; pressure pain threshold; adverse effects and global perception of change were evaluated at baseline, after the end of treatment and after 30-day follow-up. RESULTS The recruitment rate was 4.66% participants/month. The proportion of eligible patients randomly assigned to each group and for those who completed the 30-day follow-up was 88.23% and 100%, respectively. Both groups improved in headache-related outcomes. The perception of change was important for 67% of the PNF group and 47% of the static stretching group. No differences were found between groups regarding the studied outcomes. CONCLUSION This is a feasible pilot trial. The PNF contract-relax technique was no more effective than static stretching for treating migraine, but both techniques improved the headache, the severity of migraine-related disability and the satisfaction after treatment.",2020,"The PNF contract-relax technique was no more effective than static stretching for treating migraine, but both techniques improved the headache, the severity of migraine-related disability and the satisfaction after treatment.","['30 migraineur women (23\u202f±\u202f4 years) into', 'women']","['Contract-relax technique', 'static stretching', 'PNF', 'proprioceptive neuromuscular facilitation (PNF) contract-relax technique']","['recruitment rate', 'headache characteristics; medication intake; severity of migraine-related disability; neck disability; cervical mobility; pressure pain threshold; adverse effects and global perception of change']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0454483', 'cui_str': 'Contract relax technique'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0423781,"The PNF contract-relax technique was no more effective than static stretching for treating migraine, but both techniques improved the headache, the severity of migraine-related disability and the satisfaction after treatment.","[{'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Wanderley', 'Affiliation': 'Physical Therapy Department, Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: deborawanderley84@hotmail.com.'}, {'ForeName': 'Marcelo Moraes', 'Initials': 'MM', 'LastName': 'Valença', 'Affiliation': 'Neuropsychiatry Department, Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: mmvalenca@yahoo.com.br.'}, {'ForeName': 'Joaquim José', 'Initials': 'JJ', 'LastName': 'de Souza Costa Neto', 'Affiliation': 'Clinic Medicine Department, Universidade de Pernambuco, Recife, PE, Brazil. Electronic address: joaqcosta@yahoo.com.br.'}, {'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'Martins', 'Affiliation': 'Physical Therapy Department, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: josevicentepnf@terra.com.br.'}, {'ForeName': 'Maria Cristina Falcão', 'Initials': 'MCF', 'LastName': 'Raposo', 'Affiliation': 'Statistic Department, Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: cristina@de.ufpe.br.'}, {'ForeName': 'Daniella Araújo', 'Initials': 'DA', 'LastName': 'de Oliveira', 'Affiliation': 'Physical Therapy Department, Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: sabinodaniellaufpe@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.023'] 2112,32507152,Does whole body vibration training improve heart rate variability in kidney transplants patients? A randomized clinical trial.,"BACKGROUND Whole-body vibration (WBV) is an exercise modality that can promote improvements in heart rate variability (HRV) with lower patient overload, and consequently reduce cardiovascular risk in renal transplant patients. The aim of this study was to evaluate the effects of a 12-week WBV training program of two weekly sessions on HRV. METHODS A double-blind, randomized controlled clinical trial with 12 kidney transplant recipients of both genders who underwent WBV training (35 Hz) twice a week for 12 weeks on alternate days (WBV Group) and training with sub-therapeutic WBV (8 Hz) (Sham Group). Variables were evaluated in time and frequency domains of HRV through the 24-h Holter monitor, heart rate (HR), blood pressure (BP) and maximum oxygen consumption (VO 2max ) through an exercise stress test. RESULTS The delta between Sham and WBV groups showed an increase in the low frequency (Δ = 959.05 Hz; p = 0.01) and in the high frequency (Δ = 204.42 Hz; p = 0.04) of the HRV compared to Sham group. No changes in the ergometric variables were observed for any of the groups. CONCLUSION The present study evidenced an increase in the low and high frequency of HRV in individuals who participated in the Sham WBV group. There was no improvement in the autonomic balance in the groups, in the other HRV parameters, or the exercise test after the WBV training period.",2020,"There was no improvement in the autonomic balance in the groups, in the other HRV parameters, or the exercise test after the WBV training period.","['renal transplant patients', 'kidney transplants patients', 'individuals who participated in the Sham WBV group', '12 kidney transplant recipients of both genders who underwent']","['body vibration training', 'Whole-body vibration (WBV', 'WBV training (35\u202fHz) twice a week for 12 weeks on alternate days (WBV Group) and training with sub-therapeutic WBV (8\u202fHz) (Sham Group']","['time and frequency domains of HRV through the 24-h Holter monitor, heart rate (HR), blood pressure (BP) and maximum oxygen consumption (VO 2max ) through an exercise stress test', 'ergometric variables', 'low frequency', 'heart rate variability (HRV', 'heart rate variability', 'autonomic balance']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.066364,"There was no improvement in the autonomic balance in the groups, in the other HRV parameters, or the exercise test after the WBV training period.","[{'ForeName': 'Tuíra O', 'Initials': 'TO', 'LastName': 'Maia', 'Affiliation': 'Post-Graduation Program Health Sciences, Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: tuiraomaia@gmail.com.'}, {'ForeName': 'Dulciane N', 'Initials': 'DN', 'LastName': 'Paiva', 'Affiliation': 'Post-Graduation Program in Health Promotion, Universidade de Santa Cruz do Sul, Santa Cruz do Sul, RS, Brazil. Electronic address: dulciane@unisc.br.'}, {'ForeName': 'Dário C', 'Initials': 'DC', 'LastName': 'Sobral Filho', 'Affiliation': 'Coronary Care Unit of Pernambuco Cardiac Emergency Hospital, Universidade de Pernambuco, Recife, PE, Brazil. Electronic address: dsobral@uol.com.br.'}, {'ForeName': 'Frederico C B', 'Initials': 'FCB', 'LastName': 'Cavalcanti', 'Affiliation': 'Real Portuguese Hospital of Beneficence of Pernambuco, Recife, PE, Brazil. Electronic address: frcastelo@uol.com.br.'}, {'ForeName': 'Lívia G', 'Initials': 'LG', 'LastName': 'Rocha', 'Affiliation': 'Post-Graduation Program in Physical Therapy, Universidade Federal de Pernambuco, Recife, Brazil. Electronic address: liviagomesrocha@hotmail.com.'}, {'ForeName': 'Camila C A', 'Initials': 'CCA', 'LastName': 'Andrade', 'Affiliation': 'Integrated Multiprofessional Residency Program in Health, Clinics Hospital of Universidade Federal de Pernambuco, Brazil. Electronic address: camilaalvesccaa@gmail.com.'}, {'ForeName': 'Aluísio R A', 'Initials': 'ARA', 'LastName': 'Macedo Júnior', 'Affiliation': 'Clinics Hospital of Universidade Federal de Pernambuco, Recife, PE, Brazil. Electronic address: alumacedojr@hotmail.com.'}, {'ForeName': 'Patrícia E M', 'Initials': 'PEM', 'LastName': 'Marinho', 'Affiliation': 'Post-Graduation Program Health Sciences, Universidade Federal de Pernambuco, Recife, PE, Brazil; Post-Graduation Program in Physical Therapy, Universidade Federal de Pernambuco, Recife, Brazil. Electronic address: patmarinho@yahoo.com.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.031'] 2113,32507154,The effect of 8 weeks proprioception training without visual input on single-limb standing balance time in deaf students: A randomized controlled trial.,"INTRODUCTION The aim of this study was to determine the effects of 8 weeks proprioception training without visual input on the proprioception of the knee and ankle and single standing balance time in deaf students. METHODS Twenty male deaf students participated in this study and were randomly assigned into control (n = 10) and experimental (n = 10) groups. Subjects' proprioception was measured using an electrogoniometer. In addition, balance performance was evaluated through single-limb standing performance test under four sensory conditions (condition 1: eyes open on one leg; condition 2: eyes closed on one leg; condition 3: eyes open on foam; condition 4: eyes closed on foam). RESULTS The findings showed that proprioception training without visual input induced meaningful, significant effects in knee and ankle proprioception (p ≤ 0.001), and single-limb standing time of deaf students at condition 1 (p ≤ 0.03) and 2 (p ≤ 0.001). However, training programs did not have any significant effects on single-limb standing time in conditions 3 (p ≤ 0.41) and 4(p ≤ 0.22). CONCLUSIONS Proprioception training without visual input improves proprioception of ankle, knee and single-limb standing balance time in deaf students.",2020,"The findings showed that proprioception training without visual input induced meaningful, significant effects in knee and ankle proprioception (p ≤ 0.001), and single-limb standing time of deaf students at condition 1 (p ≤ 0.03) and 2 (p ≤ 0.001).","['Twenty male deaf students', 'deaf students']","['Proprioception training without visual input', 'proprioception training without visual input', 'single-limb standing performance test under four sensory conditions (condition 1: eyes open on one leg; condition 2: eyes closed on one leg; condition 3: eyes open on foam; condition 4: eyes closed on foam']","['proprioception of ankle, knee and single-limb standing balance time', 'knee and ankle proprioception', 'single-limb standing time of deaf students', 'single-limb standing time']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",20.0,0.0367565,"The findings showed that proprioception training without visual input induced meaningful, significant effects in knee and ankle proprioception (p ≤ 0.001), and single-limb standing time of deaf students at condition 1 (p ≤ 0.03) and 2 (p ≤ 0.001).","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Zarei', 'Affiliation': 'Master of Physical Education (corrective Exercise and Sport Injuries), Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Zareei.h@yahoo.com.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Norasteh', 'Affiliation': 'Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Asgharnorasteh@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.09.002'] 2114,32507156,Effect of push-up variations performed with Swiss ball on muscle electromyographic amplitude in trained men: A cross-sectional study.,"PURPOSE To compare the use of three variations of push-ups: traditional (stable surface), performed with hands on the Swiss ball (Swiss ball-hands), and performed with feet on the Swiss ball (Swiss ball-feet) on surface electromyography activity (sEMG) in the agonist and stabilizer muscles. METHODS Ten trained men (26 ± 5 years, 76.8 ± 8.7 kg, 1.70 ± 0.06 m) performed one experimental protocol within-subjects in a randomized design. Each subject performed one set of 10 of each of the push-up variations (5-min rest between sets). The sEMG activity was assessed for pectoralis major, triceps brachii, anterior deltoids, and rectus abdominis. One-way repeated-measures ANOVA (Bonferroni) compared push-up variations within-muscles (p < 0.05). RESULTS Pectoralis major sEMG was similar between exercises. Anterior deltoid sEMG activity was greater for stable surface than for Swiss ball-hands (p = 0.001). Triceps brachii sEMG activity was greater during Swiss ball-hands than during stable surface (p = 0.001) and Swiss ball-feet (p = 0.043), and Swiss ball-feet was greater than stable surface (p = 0.001). Rectus abdominis sEMG activity was greater during Swiss ball-hands than during stable surface (p = 0.0001) and Swiss ball-feet (p = 0.036), while Swiss ball-feet was greater than stable surface (p = 0.046). CONCLUSIONS Push-ups performed with hands on the Swiss ball may be considered an advanced variation that should be used when the goal is to achieve greater challenge of the rectus abdominis and triceps brachii. Novice subjects or those with weakness/injury should perform push-ups with hands on a stable surface, and with progression, push-ups with feet on Swiss ball could be adopted before hands on Swiss ball.",2020,"Triceps brachii sEMG activity was greater during Swiss ball-hands than during stable surface (p = 0.001) and Swiss ball-feet (p = 0.043), and Swiss ball-feet was greater than stable surface (p = 0.001).","['trained men', 'Ten trained men (26\u202f±\u202f5 years, 76.8\u202f±\u202f8.7\u202fkg']","['push-up variations performed with Swiss ball', 'push-ups: traditional (stable surface), performed with hands on the Swiss ball (Swiss ball-hands']","['surface electromyography activity (sEMG', 'Rectus abdominis sEMG activity', 'muscle electromyographic amplitude', 'Triceps brachii sEMG activity', 'Anterior deltoid sEMG activity']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517880', 'cui_str': '8.7'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2721273', 'cui_str': 'Balance ball exerciser'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}]",10.0,0.0148488,"Triceps brachii sEMG activity was greater during Swiss ball-hands than during stable surface (p = 0.001) and Swiss ball-feet (p = 0.043), and Swiss ball-feet was greater than stable surface (p = 0.001).","[{'ForeName': 'Ewertton de Souza', 'Initials': 'ES', 'LastName': 'Bezerra', 'Affiliation': 'Laboratório de Estudo do Desempenho Humano, Faculdade de Educação Física e Fisioterapia, Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Lucas Bet da Rosa', 'Initials': 'LBDR', 'LastName': 'Orssatto', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Electronic address: l.betdarosaorssatto@qut.edu.au.'}, {'ForeName': 'Leonardo C', 'Initials': 'LC', 'LastName': 'Werlang', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Arthur Miranda', 'Initials': 'AM', 'LastName': 'Generoso', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Moraes', 'Affiliation': 'Extreme Performance LTDA, Manaus, Brazil.'}, {'ForeName': 'Raphael L', 'Initials': 'RL', 'LastName': 'Sakugawa', 'Affiliation': 'Laboratório de Biomecânica, Centro de Desportos, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.09.004'] 2115,32507383,Thrombin Generation in a patient with Triple Positive Antiphospholipid Syndrome Treated with Three Different Anticoagulants.,"INTRODUCTION Venous and arterial thrombosis is one of the hallmarks of Antiphospholipid Antibody Syndrome (APS). The traditional treatment for individuals with APS and venous thrombosis has been vitamin K antagonists. However, with the widespread use of direct oral anticoagulants (DOACs) there has been conflicting evidence regarding their safety and failure rate as alternatives to warfarin. Reasons for this failure remain elusive. We utilized the thrombin generation assay (TGA) to investigate the anticoagulation efficacy of three different agents in a patient with triple-positive APS to acquire a better understanding of the pathophysiology of APS. METHODS Blood samples were obtained from a single patient with APS at five distinct time points while on three different anticoagulants: rivaroxaban, warfarin, and enoxaparin. The effects of these anticoagulants on TG potential were evaluated using the TGA. RESULTS In the presence of thrombomodulin, rivaroxaban had the highest endogenous thrombin potential, thrombin peak, velocity index, and thrombin inactivation velocity (821.9 nMmin, 121.5 nM, 36.44 nM/min, 7.19 nM/min) when compared to warfarin (121-367 nMmin, 13.85-121.5 nM, 3.02-3.85 nM/min, 0.64-4.55 nM/min) and enoxaparin (242-378.8 nM min, 21.33-23.78 nM, 2.87-3.85 nM/min, 0.747-0.784 nM/min). This trend was also observed in the absence of thrombomodulin. CONCLUSIONS These results suggest that patients with APS treated with rivaroxaban may be at greater risk for thrombosis compared to warfarin or enoxaparin. The findings may provide insight into the recent studies in patients with triple positive APS randomized to different anticoagulants demonstrating high rates of thrombosis with rivaroxaban. Further studies are necessary to elucidate the clinical significance.",2020,"In the presence of thrombomodulin, rivaroxaban had the highest endogenous thrombin potential, thrombin peak, velocity index, and thrombin inactivation velocity (821.9 nMmin, 121.5 nM, 36.44 nM/min, 7.19 nM/min) when compared to warfarin (121-367 nMmin, 13.85-121.5 nM, 3.02-3.85 nM/min, 0.64-4.55 nM/min) and enoxaparin (242-378.8 nM min, 21.33-23.78 nM, 2.87-3.85 nM/min, 0.747-0.784 nM/min).","['patients with APS treated with', 'individuals with APS and venous thrombosis', 'patients with triple positive APS', 'Blood samples were obtained from a single patient with APS at five distinct time points while on three different anticoagulants']","['thrombomodulin, rivaroxaban', 'Thrombin Generation', 'warfarin', 'thrombin generation assay (TGA', 'rivaroxaban', 'enoxaparin', 'rivaroxaban, warfarin, and enoxaparin']","['highest endogenous thrombin potential, thrombin peak, velocity index, and thrombin inactivation velocity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0370686,"In the presence of thrombomodulin, rivaroxaban had the highest endogenous thrombin potential, thrombin peak, velocity index, and thrombin inactivation velocity (821.9 nMmin, 121.5 nM, 36.44 nM/min, 7.19 nM/min) when compared to warfarin (121-367 nMmin, 13.85-121.5 nM, 3.02-3.85 nM/min, 0.64-4.55 nM/min) and enoxaparin (242-378.8 nM min, 21.33-23.78 nM, 2.87-3.85 nM/min, 0.747-0.784 nM/min).","[{'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Bergstrom', 'Affiliation': 'Department of Internal Medicine, Dallas, TX, United States. Electronic address: Colin.Bergstrom@phhs.org.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Zia', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Dallas, TX, United States.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Sarode', 'Affiliation': 'Division of Transfusion Medicine and Hemostasis, Department of Pathology, Dallas, TX, United States; Division of Hematology/Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Nagalla', 'Affiliation': 'Division of Hematology/Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2020.102815'] 2116,32507389,Pretreatment Reward Sensitivity and Frontostriatal Resting-State Functional Connectivity Are Associated With Response to Bupropion After Sertraline Nonresponse.,"BACKGROUND Standard guidelines recommend selective serotonin reuptake inhibitors as first-line antidepressants for adults with major depressive disorder, but success is limited and patients who fail to benefit are often switched to non-selective serotonin reuptake inhibitor agents. This study investigated whether brain- and behavior-based markers of reward processing might be associated with response to bupropion after sertraline nonresponse. METHODS In a two-stage, double-blinded clinical trial, 296 participants were randomized to receive 8 weeks of sertraline or placebo in stage 1. Individuals who responded continued on another 8-week course of the same intervention in stage 2, while sertraline and placebo nonresponders crossed over to bupropion and sertraline, respectively. Data from 241 participants were analyzed. The stage 2 sample comprised 87 patients with major depressive disorder who switched medication and 38 healthy control subjects. A total of 116 participants with major depressive disorder treated with sertraline in stage 1 served as an independent replication sample. The probabilistic reward task and resting-state functional magnetic resonance imaging were administered at baseline. RESULTS Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline. Null findings for sertraline were replicated in the stage 1 sample. CONCLUSIONS Pretreatment reward sensitivity and frontostriatal connectivity may identify patients likely to benefit from bupropion following selective serotonin reuptake inhibitor failures. Results call for a prospective replication based on these biomarkers to advance clinical care.",2020,"RESULTS Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline.","['adults with major depressive disorder', '241 participants were analyzed', '296 participants', '87 patients with major depressive disorder who switched medication and 38 healthy control subjects', '116 participants with major depressive disorder treated with sertraline in stage 1 served as an independent replication sample']","['sertraline', 'Bupropion', 'sertraline and placebo', 'sertraline or placebo', 'bupropion and sertraline']","['Pretreatment Reward Sensitivity and Frontostriatal Resting-State Functional Connectivity', 'reward sensitivity and higher resting-state functional connectivity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205250', 'cui_str': 'High'}]",296.0,0.273947,"RESULTS Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline.","[{'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Roselinde', 'Initials': 'R', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, Texas.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deldin', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bruder', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Cherise R', 'Initials': 'CR', 'LastName': 'Chin Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.04.009'] 2117,32507404,Presentation and short-term evaluation of an all-in-one patient-specific implant for cranial reconstruction: A randomized controlled trial.,"Cranial reconstruction after bone graft harvesting remains a challenge. A patient-specific implant (PSI) to guide harvesting and reconstruction was evaluated and compared with the use of a free-hand procedure with calcium phosphate cement (C). Patients were randomized to either the PSI or C group. The outcome was measured clinically and radiographically as the primary endpoint. Secondary endpoints were ease of application, patient and surgeon satisfaction, and the complication rate. Twenty patients were randomized to the PSI (n=10) and C (n=10) groups. Two PSI patients were switched to the cement group due to a poor fit of the PSI. There was a non-significant trend towards more successful outcomes in the PSI group. Two PSI patients presented palpable screws, and one cement patient had a palpable dimple. Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001). The total surgical manipulation time was significantly higher in the PSI group. At 10 days postoperative, three PSI and two C patients presented with minor postoperative complications. There was no significant difference in patient or surgeon satisfaction. PSIs are a reliable alternative to cement. This PSI is novel as it also serves as a guide for harvesting the bone blocks required for reconstructive purposes.",2020,Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001).,"['cranial reconstruction', 'Twenty patients were randomized to the PSI (n=10) and C (n=10) groups']",['calcium phosphate cement (C'],"['patient or surgeon satisfaction', 'total surgical manipulation time', 'ease of application, patient and surgeon satisfaction, and the complication rate', 'postoperative complications', 'successful outcomes', 'median volume discrepancy']","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}]",20.0,0.029954,Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'De Cuyper', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium. Electronic address: brecht.decuyper@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pottel', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Würsching', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abeloos', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'De Ceulaer', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Neyt', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamoral', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Swennen', 'Affiliation': 'Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende, Bruges, Belgium.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.04.002'] 2118,32507421,"Efficacy of the plantago major L. syrup on radiation induced oral mucositis in head and neck cancer patients: A randomized, double blind, placebo-controlled clinical trial.","INTRODUCTION Oral mucositis is a complication of radiation therapy in cancer patients. We designed a trial to evaluate efficacy of plantago major on symptoms of radiation induced mucositis in cancer patients. METHODS In this randomized double blind, placebo-controlled trial 23 patients received plantago major syrup as intervention group and 23 patients received placebo syrup as control group for 7 weeks. Outcome measures were severity of mucositis according to WHO scale and severity of patients' pain assessed by visual analogue scale. RESULTS Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05). Also patients in intervention group experienced significantly less pain compared to placebo group during radiotherapy period (p value<0.05) CONCLUSION: Plantago major L syrup was effective on the reduction of the symptoms of radiation induced mucositis in patients with head and neck cancers.",2020,"RESULTS Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05).","['head and neck cancer patients', 'cancer patients', 'patients with head and neck cancers']","['placebo syrup', 'plantago major syrup', 'plantago major L. syrup', 'Plantago major L syrup', 'placebo']","['Severity of mucositis', ""severity of mucositis according to WHO scale and severity of patients' pain assessed by visual analogue scale"", 'oral mucositis', 'pain']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C3488573', 'cui_str': 'Plantago major extract'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.29297,"RESULTS Severity of mucositis were significantly lower in intervention group compared to placebo group (p value<0.05).","[{'ForeName': 'Gholamreza Mohammad', 'Initials': 'GM', 'LastName': 'Soltani', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: Gsoltani@arakmu.ac.ir.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hemati', 'Affiliation': 'Department of Radiation Oncology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: hematti@med.mui.ac.ir.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sarvizadeh', 'Affiliation': 'Department of Radiation Oncology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sarvizadeh83@arakmu.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran. Electronic address: mkamalinejad@sbmu.ac.ir.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Tafazoli', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Stud4469948004@sums.ac.ir.'}, {'ForeName': 'Seied AmirHossein', 'Initials': 'SA', 'LastName': 'Latifi', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: Sah.latifi@arakmu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102397'] 2119,32507436,"Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial.","BACKGROUND Obesity is a global health problem and its incidence is on the rise. Euiiyin-tang is an herbal medicinal formula that is often used in the clinical treatment of obesity. The purpose of the present study was to evaluate the efficacy and safety of Euiiyin-tang in obesity treatment. METHODS A randomized, double-blind, placebo-controlled, multicenter trial was conducted. Participants with obesity were randomly assigned to receive Euiiyin-tang or placebo 3 times daily for 12-weeks. The primary outcome was weight reduction between the baseline and 12 weeks. The secondary outcomes included the rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet. Safety factors, such as vital signs and laboratory parameters, were also measured. RESULTS A total of 149 participants were randomly distributed to either the Euiiyin-tang group (n = 76) or the placebo group (n = 73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50 kg in the Euiiyin-tang group vs. 0.82 kg in the placebo group). The participant response rates of ≥3% weight loss compared to baseline was 36.8 % in the Euiiyin-tang group and 17.8 % in the placebo group. Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group). Questionnaires, lipid profiles, and safety factors did not show significant differences between groups. CONCLUSION The results of this study suggest that Euiiyin-tang has beneficial effects on weight loss. TRIAL REGISTRATION Clinicaltrials.gov NCT01724099.",2020,"Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group).","['Korean women with obesity', 'Participants with obesity', 'A total of 149 participants']","['Euiiyin-tang or placebo', 'Euiiyin-tang', 'placebo']","['response rates of ≥3% weight loss', 'Efficacy and safety', 'Body mass index, waist circumference, and hip circumference', 'efficacy and safety', 'weight loss', 'rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet', 'Weight reduction', 'weight reduction', 'Questionnaires, lipid profiles, and safety factors']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",149.0,0.597809,"Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group).","[{'ForeName': 'Chunhoo', 'Initials': 'C', 'LastName': 'Cheon', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea. Electronic address: hreedom35@gmail.com.'}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Department of Korean Medicine Rehabilitation, College of Korean Medicine, Gachon University, 1342 Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea. Electronic address: lyricsong@naver.com.'}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Kyungheedae-ro 26, Dongdaemun-gu, Seoul 02447, Republic of Korea. Electronic address: epiko@khu.ac.kr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102423'] 2120,32507439,"Effects of garlic powder supplementation on insulin resistance, oxidative stress, and body composition in patients with non-alcoholic fatty liver disease: A randomized controlled clinical trial.","BACKGROUND Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Insulin resistance, oxidative stress, and obesity are major contributors to NAFLD pathogenesis. The effects of garlic powder supplementation on these risk factors in patients with NAFLD was investigated. METHODS In this 12-wk, randomized controlled clinical trial, ninety patients with NAFLD were randomly assigned to two groups. The treatment group received four tablets of garlic (each coated tablet contained 400 mg garlic powder) daily and the control group received four tablets of placebo (each coated tablet contained 400 mg starch). RESULTS A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001). CONCLUSION Garlic powder supplementation improved risk factors of NAFLD. Further studies are needed to determine the effects of garlic on hepatic features in patients with NAFLD. The study protocol was registered at Iranian clinical trials website under code IRCT20170206032417N4.",2020,"A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001). ","['patients with NAFLD', 'patients with NAFLD was investigated', 'ninety patients with NAFLD', 'patients with non-alcoholic fatty liver disease']","['placebo', 'Garlic powder supplementation', 'garlic powder supplementation', 'garlic']","['insulin resistance, oxidative stress, and body composition', 'waist circumference', 'risk factors of NAFLD', 'serum concentration of superoxide dismutase', 'serum concentration of fasting blood sugar', 'skeletal muscle mass', 'homeostatic model assessment for insulin resistance', 'total antioxidant capacity', 'Insulin resistance, oxidative stress, and obesity', 'body fat percent']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1119842', 'cui_str': 'GARLIC POWDER'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",90.0,0.430577,"A significant decrease was seen in the treatment group compared to the control group in waist circumference (P = 0.001), body fat percent (P < 0.001), serum concentration of fasting blood sugar (P = 0.01), insulin (P < 0.001), homeostatic model assessment for insulin resistance (P < 0.001), and malondialdehyde (P < 0.001), as well as significant increase in skeletal muscle mass (P = 0.002), serum concentration of superoxide dismutase (P < 0.001), and total antioxidant capacity (P < 0.001). ","[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Sangouni', 'Affiliation': 'Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammad Hosseini Azar', 'Affiliation': 'Gastroenterology and Hepatology Subdivision of Internal Medicine, Imam Khomeini Hospital, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alizadeh', 'Affiliation': 'Food and Beverages Safety Research Center, Urmia University of Medical Sciences, Urmia, Iran; Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: alizadeh.m@umsu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102428'] 2121,32507443,"Effects of dry needling on pain, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis: Secondary analysis of a randomized controlled trial.","OBJECTIVE To determine the changes produced by dry needling in active myofascial trigger points in hip muscles compared to a sham needling on pain intensity, main pain area, pressure pain threshold and psychological distress in patients with hip osteoarthritis. DESIGN Secondary analysis of a single-centre, randomized, double-blinded, clinical trial. INTERVENTION 30 participants with mild to moderate hip osteoarthritis were randomly assigned to DN group (n = 15) or sham DN group (n = 15). DN group received three sessions of penetrating DN, and sham DN group received three sessions of non-penetrating DN in hip muscles. MAIN OUTCOME MEASURES Pain intensity (Visual Analogue Scale), main pain area (body chart), pressure pain threshold (algometry), psychological distress (Hospital Anxiety and Depression Scale) and self-reported improvement (Global Rate of Change) were measured before and after treatment. RESULTS DN group showed statistically significant improvements with large effect sizes for pain intensity (p < 0.001; E.S: 2.7), pressure pain thresholds (p < 0.05; E.S: 1.3-1.8) and psychological distress (p = 0.002; E.S: 1.5) compared to sham DN group. The DN group described a self-reported improvement categorised as quite a bit, great or very great deal better (n = 12, 80%). No statistically significant differences were found between baseline and postintervention in the sham DN group in any variable (p > 0.05). CONCLUSIONS Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.",2020,"CONCLUSIONS Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.","['30 participants with mild to moderate hip osteoarthritis', 'patients with hip osteoarthritis', 'patients with mild to moderate hip osteoarthritis']","['penetrating DN, and sham DN group received three sessions of non-penetrating DN in hip muscles', 'dry needling', 'sham DN', 'sham needling']","['Pain intensity (Visual Analogue Scale), main pain area (body chart), pressure pain threshold (algometry), psychological distress (Hospital Anxiety and Depression Scale) and self-reported improvement (Global Rate of Change', 'pain intensity, main pain area, pressure pain threshold and psychological distress', 'pain, pressure pain threshold and psychological distress', 'pain intensity, pressure pain threshold and psychological distress', 'pain intensity', 'pressure pain thresholds', 'psychological distress']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.401098,"CONCLUSIONS Three sessions of dry needling were more effective than sham dry needling for improving pain intensity, pressure pain threshold and psychological distress in patients with mild to moderate hip osteoarthritis in the short term.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ceballos-Laita', 'Affiliation': 'Department of Surgery, Ophtalmology and Physiotherapy, University of Valladolid.c/Universidad s/n 42004, Soria, Spain. Electronic address: luis.ceballos@uva.es.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jiménez-Del-Barrio', 'Affiliation': 'Department of Surgery, Ophtalmology and Physiotherapy, University of Valladolid.c/Universidad s/n 42004, Soria, Spain. Electronic address: Sandra.jimenez.barrio@uva.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Zurdo', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: jjmarin@unizar.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Moreno-Calvo', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: alexmor1993@hotmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Marín-Boné', 'Affiliation': 'ID_ERGO Research group, I3A, Department: Design and Manufacturing Engineering. University of Zaragoza, Spain. Electronic address: javiermar1993@gmail.com.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Albarova-Corral', 'Affiliation': 'Department of Physiatrist and Nursey, Faculty of Health Sciencies, University of Zaragoza, c/Domingo Miral s/n, 50010, Zaragoza, Spain. Electronic address: isabelalbarova@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Estébanez-de-Miguel', 'Affiliation': 'Department of Physiatrist and Nursey, Faculty of Health Sciencies, University of Zaragoza, c/Domingo Miral s/n, 50010, Zaragoza, Spain. Electronic address: elesteba@unizar.es.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102443'] 2122,32507446,"A pilot study of the effect of curcumin on epigenetic changes and DNA damage among patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled, clinical trial.","BACKGROUND The enhancement of oxidative stress in non-alcoholic fatty liver disease (NAFLD) patients may cause mutation in DNA by deamination of cytosine to 5-hydroxyuracil or uracil. This study aimed to discover the effects of curcumin on NAFLD progress, DNA damage caused by oxidative stress, and promoter methylation of mismatch repair enzymes. MATERIAL AND METHODS in this study, 54 NAFLD patients were randomly devided into two groups, according to a double blind parallel design either phytosomal curcumin (250 mg/day) or placebo for 8 weeks. Fasting blood samples and anthropometric measures were taken twice, once at the baseline and once at the end of the study. Promoter methylation and 8-hydroxy-2' -deoxyguanosine (8-OHdG) concentration as DNA damage mediator were measured by restriction enzymes and enzyme-linked immunosorbent assay, respectively. RESULT Analysis was performed on 44 patients. According to our between groups analysis, curcumin significantly reduced the methylation in MutL homolog 1 (MLH1) and MutS homolog 2 (MSH2) promoter regions. The within-group comparison revealed that anthropometric variables significantly decreased. However, the result of the between groups comparison indicated no significant changes in the anthropometric variables except for BMI. Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group. CONCLUSION Curcumin might be able to reduce the risk of mismatch base pair in DNA among the NAFLD patients. However, it did not change the DNA damage mediator and liver enzymes. For confirming these results, more studies with longer duration, more numbers of examined genes, higher dose of curcumin, and larger sample size are required.",2020,"Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group. ","['44 patients', '54 NAFLD patients', 'non-alcoholic fatty liver disease (NAFLD) patients', 'patients with non-alcoholic fatty liver disease']","['curcumin', 'phytosomal curcumin', 'placebo']","['DNA damage mediator and liver enzymes', 'Fasting blood samples and anthropometric measures', 'Liver enzymes and 8-OHdG', 'epigenetic changes and DNA damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C1516924', 'cui_str': 'Epigenetic Process'}]",54.0,0.27031,"Liver enzymes and 8-OHdG did not significantly change at the end of the study, neither in curcumin group nor in placebo group. ","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Hariri', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran. Electronic address: Haririm1@nums.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gholami', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran; Department of Epidemiology & Biostatistics, School of Public Health, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mirhafez', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bidkhori', 'Affiliation': 'Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102447'] 2123,32406064,Short-term skin reactions following use of N95 respirators and medical masks.,"BACKGROUND In the context of the COVID-19 pandemic, cases of adverse skin reactions related to the wearing of masks have been observed. OBJECTIVES To analyze the short-term effects of N95 respirators and medical masks, respectively, on skin physiological properties and to report adverse skin reactions caused by the protective equipment. METHODS This study used a randomized crossover design with repeated measurements. Twenty healthy Chinese volunteers were recruited. Skin parameters were measured on areas covered by the respective masks and on uncovered skin 2 and 4 hours after donning, and 0.5 and 1 hour after removing the masks, including skin hydration, transepidermal water loss (TEWL), erythema, pH, and sebum secretion. Adverse reactions were clinically assessed, and perceived discomfort and non-compliance measured. RESULTS Skin hydration, TEWL, and pH increased significantly with wearing the protective equipment. Erythema values increased from baseline. Sebum secretion increased both on the covered and uncovered skin with equipment-wearing. There was no significant difference in physiological values between the two types of equipment. More adverse reactions were reported following a N95 mask use than the use of a medical mask, with a higher score of discomfort and non-compliance. CONCLUSIONS This study demonstrates that skin biophysical characters change as a result of wearing a mask or respirator. N95 respirators were associated with more skin reactions than medical masks.",2020,"More adverse reactions were reported following a N95 mask use than the use of a medical mask, with a higher score of discomfort and",['Twenty healthy Chinese volunteers'],['N95 respirators and medical masks'],"['skin reactions', 'Sebum secretion', 'Skin hydration, TEWL, and pH increased significantly with wearing the protective equipment', 'perceived discomfort and non-compliance measured', 'physiological values', 'Erythema values', 'adverse reactions', 'Skin parameters', 'Adverse reactions', 'skin hydration, transepidermal water loss (TEWL), erythema, pH, and sebum secretion']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0232436', 'cui_str': 'Sebaceous gland activity'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0221106', 'cui_str': 'Alkalemia'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031845', 'cui_str': 'Physiological process'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.0210399,"More adverse reactions were reported following a N95 mask use than the use of a medical mask, with a higher score of discomfort and","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ruoyu', 'Initials': 'R', 'LastName': 'Wan', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Cosmetic Safety and Efficacy Evaluation Center of West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Cosmetic Safety and Efficacy Evaluation Center of West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Cosmetic Safety and Efficacy Evaluation Center of West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Cosmetic Safety and Efficacy Evaluation Center of West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}]",Contact dermatitis,['10.1111/cod.13601'] 2124,32511143,No Difference in Pain After Spine Surgery with Local Wound Filtration of Morphine and Ketorolac: A Randomized Controlled Trial.,"BACKGROUND Controlling postoperative pain after spinal surgery is important for rehabilitation and patient satisfaction. Wound infiltration with local anesthetics may improve postoperative pain, but true multimodal approaches for achieving analgesia after spinal surgery remain unknown. QUESTIONS/PURPOSES In this randomized, controlled, double-blind trial after lumbar interbody fusion, we asked: (1) Does multimodal analgesia reduce VAS pain scores by a clinically important amount? (2) Does this analgesic approach reduce the amount of morphine patients consume after surgery? (3) Is this approach associated with fewer opioid-related side effects after surgery? METHODS This study included 80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine 100 mg (20 mL) and epinephrine 0.5 mg (0.5 mL), and the multimodal group (n = 40), who received wound infiltration with the same approach but with different medications: 0.5% bupivacaine 92.5 mg (18.5 mL), ketorolac 30 mg (1 mL), morphine 5 mg (0.5 mL), and epinephrine 0.5 mg (0.5 mL). There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time. All treatments were administered by one surgeon. All patients, the surgeon, and the researchers were blinded to the allocation of patients to each group. Pain at rest was recorded using the VAS. Postoperative morphine consumption (administered using a patient-controlled analgesia pump) and opiod-associated side effects including nausea/vomiting, pruritus, urinary retention, and respiratory depression were assessed; this study was analyzed according to intention-to-treat principles. No loss to follow-up or protocol deviations were noted. We considered a 2-cm change on a 10-cm scale on the VAS as the minimum clinically important difference (MCID). Differences smaller than this were considered unlikely to be important. RESULTS At no point were there between-group differences in the VAS scores that exceeded the MCID, indicating no clinically important reductions in pain associated with administering multimodal injections. The highest treatment effect was observed at 3 hours that showed only a -1.3 cm mean difference between the multimodal and the control groups (3.2 ± 1.8 versus 4.5 ± 1.9 [95% CI -1.3 to -0.3]; p < 0.001), which was below the MCID. Morphine consumption was very slightly higher in the control group than in the multimodal group (2.8 ± 2.8 versus 0.3 ± 1.0, mean difference 2.47; p < 0.001). The percentage of patients reporting opioid-related side effects was lower in the multimodal group than in the control group. The proportions of nausea and vomiting were higher in the control group (30% [12 of 40] than in the multimodal group (3% [1 of 40]; p = 0.001). All of these side effects were transient and none was severe. CONCLUSIONS Multimodal wound infiltration with an NSAID and morphine did not yield any clinically important reduction in pain or opioid consumption. Since no substantial benefit of adding these drugs to a patient's aftercare regimen was achieved, and considering the potential risks of administering opioids and NSAIDs (such as, polypharmacy in older patients, serious adverse effects of NSAIDs), we recommend against routine use of this approach in clinical practice. LEVEL OF EVIDENCE Level I, therapeutic study.",2020,"There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time.",['80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received'],"['ketorolac 30 mg (1 mL), morphine', 'Morphine and Ketorolac', 'NSAID and morphine', 'local anesthetics', 'infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine', 'wound infiltration with the same approach but with different medications: 0.5% bupivacaine', 'Postoperative morphine consumption', 'epinephrine', 'morphine']","['Pain at rest', 'nausea/vomiting, pruritus, urinary retention, and respiratory depression', 'height, weight, preoperative pain score, or surgical time', 'postoperative pain', 'Pain', 'nausea and vomiting', 'Morphine consumption', 'pain', 'VAS pain scores', 'percentage of patients reporting opioid-related side effects', 'pain or opioid consumption', 'VAS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.351157,"There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time.","[{'ForeName': 'Weerasak', 'Initials': 'W', 'LastName': 'Singhatanadgige', 'Affiliation': 'W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand S. Honsawek, Osteoarthritis and Musculoskeleton Research Unit, Department of Biochemistry, Faculty of Medicine, KingChulalongkorn Memorial Hospital, Thai Red Cross Society, Chulalongkorn University, Bangkok, Thailand V. Kotheeranurak, Spine Unit, Department of Orthopaedics, Queen Savang Vadhana Memorial Hospital, Sriracha, Chonburi, Thailand.'}, {'ForeName': 'Todsapon', 'Initials': 'T', 'LastName': 'Chancharoenchai', 'Affiliation': ''}, {'ForeName': 'Sittisak', 'Initials': 'S', 'LastName': 'Honsawek', 'Affiliation': ''}, {'ForeName': 'Vit', 'Initials': 'V', 'LastName': 'Kotheeranurak', 'Affiliation': ''}, {'ForeName': 'Chotetawan', 'Initials': 'C', 'LastName': 'Tanavalee', 'Affiliation': ''}, {'ForeName': 'Worawat', 'Initials': 'W', 'LastName': 'Limthongkul', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001354'] 2125,32511152,Storytelling Through Music to Improve Well-being in Oncology Nurses: A Feasibility Study.,"BACKGROUND Professional grief is one cause of psychosocial stress that, if not attended to, may contribute to burnout and compassion fatigue. Oncology nurses often avoid their emotions and learn to cope with professional grief in isolation. Interventions aimed at professional grief are limited. OBJECTIVES To determine the feasibility of implementing a multidimensional intervention, Storytelling Through Music, with oncology nurses. INTERVENTION/METHODS This was a 2-group, quasi-experimental design utilizing both qualitative and quantitative methods. The 6-week intervention combined storytelling, reflective writing, music, and psychoeducation. Descriptive statistics and conventional content analysis were used to analyze the feasibility data. RESULTS Most participants (n = 43) were female, white, working full-time in the outpatient oncology setting, with an average 8.5 years (range, 2-36 years) of oncology experience. Ninety-eight percent of the intervention was completed, and 98% of participants were retained. Analysis indicates that the intervention was acceptable, the participants learned they were not alone in their feelings, and they were supported by the group. CONCLUSIONS Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses. IMPLICATIONS FOR PRACTICE In 2017, the National Academy of Medicine stated clinician well-being must be a priority. Participation in this study was independently sought out by the oncology nurses and completed during their personal time. A future policy recommendation is to make participation in wellness interventions part of the mandatory competency training required by accrediting bodies so that institutions ensure the well-being of clinicians as a priority.",2020,"CONCLUSIONS Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses. ","['Oncology Nurses', 'Most participants (n = 43) were female, white, working full-time in the outpatient oncology setting, with an average 8.5 years (range, 2-36 years) of oncology experience']","['intervention combined storytelling, reflective writing, music, and psychoeducation']",[],"[{'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]",[],43.0,0.021103,"CONCLUSIONS Results indicate that Storytelling Through Music is a feasible and acceptable intervention to address work-related emotions and psychosocial stress in this group of oncology nurses. ","[{'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Phillips', 'Affiliation': 'Author Affiliations: The Phyllis F. Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, Massachusetts (Dr Phillips); and Schools of Nursing (Drs Volker and Becker) and Law (Dr Davidson), The University of Texas at Austin.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Volker', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Davidson', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000836'] 2126,32511154,Virtual Reality Intervention Targeting Pain and Anxiety Among Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation: A Randomized Controlled Trial.,"BACKGROUND Peripheral intravenous cannulation (PIC) is commonly performed in cancer treatment and causes pain and anxiety to children with cancer. OBJECTIVE The aim of this study was to determine whether virtual reality distraction intervention can alleviate pain and anxiety and reduce length of procedure among pediatric cancer patients undergoing PIC. METHODS One hundred eight pediatric cancer patients aged 6 to 17 years were recruited from a regional public hospital in Hong Kong to participate in this randomized controlled trial. The intervention group received virtual reality distraction intervention, and the control group received standard care. The primary outcome was child-reported pain. Secondary outcomes included child-reported anxiety, pulse rate, and length of procedure. Outcome measurements were conducted at 5 minutes before, during, and immediately after the procedure. RESULTS Pediatric cancer patients in the intervention group demonstrated a significantly greater reduction in pain (estimated mean difference = -1.69, P = .007) and anxiety levels (estimated mean difference = -3.50, P < .001) compared with the control group. The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017). However, no significant difference was observed in pulse rate during and after the procedure between groups. CONCLUSIONS Findings indicate that virtual reality is safe and effective to alleviate pain and anxiety among pediatric cancer patients undergoing PIC procedure. IMPLICATIONS FOR PRACTICE Virtual reality can be considered as an adjunctive treatment to manage pain and anxiety in pediatric cancer patients before and during PIC procedure.",2020,"The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017).","['pediatric cancer patients before and during PIC procedure', 'pediatric cancer patients undergoing PIC procedure', 'pediatric cancer patients undergoing PIC', 'One hundred eight pediatric cancer patients aged 6 to 17 years were recruited from a regional public hospital in Hong Kong to participate', 'children with cancer', 'Pediatric cancer patients', 'Pediatric Cancer Patients Undergoing Peripheral Intravenous Cannulation']","['virtual reality distraction intervention, and the control group received standard care', 'Virtual Reality Intervention', 'virtual reality distraction intervention', 'Peripheral intravenous cannulation (PIC', 'virtual reality intervention']","['mean duration', 'pain and anxiety and reduce length of procedure', 'pain and anxiety', 'Pain and Anxiety', 'pulse rate', 'child-reported pain', 'pain', 'anxiety levels', 'child-reported anxiety, pulse rate, and length of procedure']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1299418', 'cui_str': 'Length of procedure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",108.0,0.142381,"The mean duration (in minutes) for the PIC procedure was significantly shorter among participants receiving virtual reality intervention compared with the control counterparts (estimated mean difference = -0.75, P = .017).","[{'ForeName': 'Cho Lee', 'Initials': 'CL', 'LastName': 'Wong', 'Affiliation': 'Author Affiliations: The Nethersole School of Nursing (Dr Wong, Prof Chan, Drs Choi and Chen, and Miss Yeung and Chan) and Department of Paediatrics (Dr Li), Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chi Kong', 'Initials': 'CK', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Carmen W H', 'Initials': 'CWH', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Man Ting', 'Initials': 'MT', 'LastName': 'Yeung', 'Affiliation': ''}, {'ForeName': 'On Na', 'Initials': 'ON', 'LastName': 'Chan', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000844'] 2127,32511165,Repeatability and Validity of Peripheral Refraction with Two Different Autorefractors.,"SIGNIFICANCE The Welch Allyn SureSight (Welch Allyn, Skaneateles Falls, NY) and Plusoptix PowerRefractor (Plusoptix, Nuremberg, Germany) are often used with infants, but little is known about the repeatability and validity of their peripheral refractive error measurements. Selecting the best instrument will support future refractive error and emmetropization studies. PURPOSE The purpose of this study was to determine the validity and repeatability of peripheral refractive error measurements and peripheral refraction profiles measured with the Welch Allyn SureSight and Plusoptix PowerRefractor compared with the criterion standard Grand Seiko WR-5100K (Grand Seiko Co., Hiroshima, Japan). METHODS Cycloplegic (tropicamide 1%) autorefraction was measured in the right eyes of 21 adult subjects (31.4 ± 10.4 years) with the three instruments in randomized order on two separate visits, at least 24 hours apart, centrally, and at 30 and 20° temporal and nasal gaze. RESULTS The SureSight measurements were within 0.24 D and not significantly different from the Grand Seiko WR-5100K in any gaze (P < .65), whereas the PowerRefractor measurements were more myopic by as much as -0.97 D and significantly different in four of the five gaze directions (P < .04). The 95% limits of agreement between occasions by gaze ranged from ±0.38 to ±0.61 D for the SureSight, similar to or slightly better than the WR-5100K (±0.31 to ±1.51 D) and the PowerRefractor (±0.72 to ±1.71 D). There were no significant differences between visits for any instrument in any gaze (P < .94). The repeatability of the SureSight was also better than that for the Grand Seiko when peripheral refraction was represented by quadratic fits to the data. CONCLUSIONS These findings suggest that the Welch Allyn SureSight is the most suitable portable autorefractor to use to monitor peripheral autorefraction based on better repeatability between occasions and better validity compared with the criterion standard Grand Seiko WR-5100K.",2020,There were no significant differences between visits for any instrument in any gaze (P < .94).,['right eyes of 21 adult subjects (31.4 ± 10.4 years'],['Cycloplegic (tropicamide 1%) autorefraction'],"['peripheral refraction', 'Repeatability and Validity of Peripheral Refraction']","[{'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",21.0,0.0342989,There were no significant differences between visits for any instrument in any gaze (P < .94).,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Mutti', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, Ohio.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001520'] 2128,32511226,"Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study.","In Haiti, 22 communes still require mass drug administration (MDA) to eliminate lymphatic filariasis (LF) as a public health problem. Several clinical trials have shown that a single oral dose of ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA) is more effective than DEC plus ALB (DA) for clearing Wuchereria bancrofti microfilariae (Mf). We performed a cluster-randomized community study to compare the safety and efficacy of IDA and DA in an LF-endemic area in northern Haiti. Ten localities were randomized to receive either DA or IDA. Participants were monitored for adverse events (AE), parasite antigenemia, and microfilaremia. Antigen-positive participants were retested one year after MDA to assess treatment efficacy. Fewer participants (11.0%, 321/2917) experienced at least one AE after IDA compared to DA (17.3%, 491/2844, P<0.001). Most AEs were mild, and the three most common AEs reported were headaches, dizziness and abdominal pain. Serious AEs developed in three participants who received DA. Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001). Of those with positive antigenemia, 17.6% (42/239) in IDA localities and 20.9% (72/344, P = 0.25) in DA localities were microfilaremic. One year after treatment, 84% percent of persons with positive filarial antigen tests at baseline could be retested. Clearance rates for filarial antigenemia were 20.5% (41/200) after IDA versus 25.4% (74/289) after DA (P = 0.3). However, 94.4% (34/36) of IDA recipients and 75.9% (44/58) of DA recipients with baseline microfilaremia were Mf negative at the time of retest (P = 0.02). Thus, MDA with IDA was at least as well tolerated and significantly more effective for clearing Mf compared to the standard DA regimen in this study. Effective MDA coverage with IDA could accelerate the elimination of LF as a public health problem in the 22 communes that still require MDA in Haiti.",2020,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"['lymphatic filariasis in Haiti', 'LF-endemic area in northern Haiti']","['IDA and DA', 'ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA', 'DA or IDA', 'diethylcarbamazine, albendazole and ivermectin', 'DEC plus ALB (DA']","['Clearance rates for filarial antigenemia', 'filarial antigenemia', 'Safety and efficacy', 'headaches, dizziness and abdominal pain', 'adverse events (AE), parasite antigenemia, and microfilaremia']","[{'cui': 'C0013884', 'cui_str': 'Lymphatic filariasis'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1621857', 'cui_str': 'Filarial worm'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}]",10.0,0.218718,Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001).,"[{'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Dubray', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Anita D', 'Initials': 'AD', 'LastName': 'Sircar', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Valery Madsen', 'Initials': 'VM', 'LastName': 'Beau de Rochars', 'Affiliation': 'University of Florida, Gainsville, Florida, United States of America.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bogus', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Abdel N', 'Initials': 'AN', 'LastName': 'Direny', 'Affiliation': 'RTI International, Washington, District of Columbia, United States of America.'}, {'ForeName': 'Jean Romuald', 'Initials': 'JR', 'LastName': 'Ernest', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'Fayette', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Hast', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Kobie', 'Initials': 'K', 'LastName': ""O'Brian"", 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Guy Emmanuel', 'Initials': 'GE', 'LastName': 'Pavilus', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Daniel Frantz', 'Initials': 'DF', 'LastName': 'Sabin', 'Affiliation': 'IMA World Health, Port-au-Prince, Haiti.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Weil', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri, United States of America.'}, {'ForeName': 'Jean Frantz', 'Initials': 'JF', 'LastName': 'Lemoine', 'Affiliation': 'Ministère de la Santé et de la Population, Port-au-Prince, Haïti.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008298'] 2129,32511726,Intra-Individual Variability in Sleep Schedule: Effects of an Internet-Based Cognitive-Behavioral Therapy for Insomnia Program and its Relation with Symptom Remission.,"STUDY OBJECTIVES Sleep schedule consistency is fundamental to cognitive behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intra-individual variability (IIV) in sleep schedule, and (2) sleep schedule IIV predicts insomnia symptom remission. METHODS This secondary analysis compares participants (N=303) randomized to an Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on ten online sleep diaries collected over two weeks at baseline and nine-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and six-month follow-up; symptom remission was defined by ISI<8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission. RESULTS At post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps<.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12). CONCLUSIONS Findings demonstrate that an Internet-delivered CBT-I program can effectively increase users' sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.",2020,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12). ",[],"['Internet-based CBT-I program (SHUTi - Sleep Healthy Using the Internet) or Internet-based patient education (PE', 'Internet-Based Cognitive-Behavioral Therapy', 'SHUTi']","['daily bedtimes and rising times on ten online sleep diaries', 'insomnia symptom remission', 'rising time variability', 'Insomnia Severity Index (ISI', 'symptom remission', 'Bedtime and rising time']",[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",303.0,0.0636908,"IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps>.18), nor did sleep schedule IIV moderate treatment response (ps>.12). ","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Shaffer', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'University of Chicago, Department of Public Health Sciences, Chicago, IL, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Laval University, Department of Psychology, Québec, QC, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ingersoll', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Thorndike', 'Affiliation': 'Pear Therapeutics, Inc, [department n/a], Boston, MA, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Ritterband', 'Affiliation': 'University of Virginia, Center for Behavioral Health and Technology, Charlottesville, VA, USA.'}]",Sleep,['10.1093/sleep/zsaa115'] 2130,32511749,Clinical outcomes and safety profile of Tenecteplase in wake-up stroke.,"BACKGROUND Tenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There is lacking data about safety and efficacy of tenecteplase in wake up stroke (WUPS). AIMS To investigate safety and efficacy of Tenecteplase compared to Alteplase in WUPS patients included in NOR-TEST. METHODS WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified RankinScale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24h as compared to admission NIHSS or NIHSS 0 at 24h. RESULTS Of 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, p=0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis. CONCLUSIONS In WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase or tenecteplase treated patients.",2020,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"['1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients', 'WUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch', 'WUPS patients included in NOR-TEST']",['intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase'],"['early neurological improvement', 'number of patients achieving a good clinical outcome', 'clinical outcomes', 'favorable functional outcome at 90 days modified RankinScale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS', 'safety and efficacy', 'ICH events or deaths', 'Neurological improvement']","[{'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1100.0,0.0389672,There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group.,"[{'ForeName': 'Hassan Khan', 'Initials': 'HK', 'LastName': 'Ahmed', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Logallo', 'Affiliation': 'Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Thomassen', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Novotny', 'Affiliation': 'Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Mathisen', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Kurz', 'Affiliation': 'Department of Neurology, Stavanger University Hospital, Stavanger, Norway.'}]",Acta neurologica Scandinavica,['10.1111/ane.13296'] 2131,32511774,Dietary Sodium Intake and Cortisol Measurements.,"Context There is substantial intraindividual variation in cortisol and dietary sodium intake. OBJECTIVE To assess the influence of a dietary sodium intake intervention on cortisol measurements within the general population. DESIGN Cross-over intervention. PATIENTS AND MEASUREMENTS 630 adults without known Cushing syndrome, cardiovascular or renal disease completed a restricted dietary sodium diet (10 mmol/day, 230 mg/day) followed by cross-over to a liberalized dietary sodium diet (200 mmol/day, 4600 mg/day). 24-hour urine collection and biochemical investigations were performed at the end of each dietary intervention. RESULTS Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001). Nearly all participants (84%) had an increase in the urinary free cortisol following liberalized sodium intake. This translated to a substantial difference in the proportion of participants exceeding categorical thresholds of urinary cortisol on liberalized vs restricted sodium intake: 62% vs 27% for 138 nmol/day (50 mcg/day), 46% vs 17% for 166 nmol/day (60 mcg/day), 32% vs 10% for 193 nmol/day (70 mcg/day), 23% vs 6% for 221 nmol/day (80 mcg/day), 17% vs 4% for 248 nmol/day (90 mcg/day). In parallel, there was a small decrease in morning total serum cortisol with liberalized sodium intake (303.0 ± 117.3 vs. 326.4 ± 162.5 nmol/L, p<0.001). CONCLUSIONS Increased dietary sodium intake increases urinary free cortisol excretion and may increase the risk for false-positive results. Variations in dietary sodium intake may influence the interpretations of cortisol measurements performed to evaluate for hypercortisolism.",2020,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","['630 adults without known Cushing syndrome, cardiovascular or renal disease completed a']","['restricted dietary sodium diet (10 mmol/day, 230 mg/day) followed by cross-over to a liberalized dietary sodium diet', 'dietary sodium intake intervention']","['Mean 24-hour urinary free cortisol', 'Dietary Sodium Intake and Cortisol Measurements', 'morning total serum cortisol', 'urinary free cortisol', 'cortisol measurements']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439433', 'cui_str': 'mmol/24h'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}]",630.0,0.0210742,"Mean 24-hour urinary free cortisol increased with liberalized sodium intake when compared with restricted sodium intake (178.0 ± 89.7 vs. 121.3 ± 65.6 nmol/day, p<0.001).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrea V', 'Initials': 'AV', 'LastName': 'Haas', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Williams', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical endocrinology,['10.1111/cen.14262'] 2132,32511775,Effects of adjunctive probiotic L. reuteri lozenges on S/RSD outcomes at molar sites with deep pockets.,"AIM To evaluate effects of probiotic Lactobacillus reuteri (L. reuteri) lozenges as an S/RSD adjunct on site-level changes at molars with deep pockets. MATERIALS AND METHODS 447 molar sites with pockets ≥ 5mm from a previous randomized clinical trial of adjunctive L. reuteri lozenges for 28 days were analyzed. Multilevel mixed-effect models (MLM) were constructed to analyze site-level outcomes 'change in CAL' and 'pocket closure' (residual PPD <5 mm) in placebo and probiotic groups at 90 and 180 days. Possible patient-, tooth-, and site-level predictors were analyzed as fixed-effects. RESULTS Estimated change in CAL in probiotic (90 day: 0.87 mm, 180 day: 0.68 mm) was greater than placebo treated molar sites (90 day: 0.73 mm, 180 day: 0.66 mm) and the relative risk (RR) of pocket closure in the probiotic group (90 day: 1.7, 180 day: 1.6) was higher as compared to placebo. Furcation involvement and BOP at site predicted significantly worse treatment outcomes. CONCLUSION As compared to S/RSD with placebo, a 28-day course of adjunctive probiotic L. reuteri lozenges improved CAL change at molar sites with ≥ 5mm deep pockets and conferred a higher probability of shallow residual pocket depth. Presence of furcation-involvement and bleeding on probing worsened treatment outcomes.",2020,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes. ","['at molar sites with deep pockets', '447 molar sites with pockets ≥ 5mm from a previous randomized clinical trial of', 'site-level changes at molars with deep pockets']","['adjunctive L. reuteri lozenges', 'probiotic Lactobacillus reuteri (L. reuteri) lozenges', 'adjunctive probiotic L. reuteri lozenges', 'placebo']","['Furcation involvement and BOP', 'CAL change', 'S/RSD outcomes', 'relative risk (RR) of pocket closure']","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",,0.290731,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes. ","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Pelekos', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nemoto', 'Affiliation': 'Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Wai Keung', 'Initials': 'WK', 'LastName': 'Leung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13329'] 2133,32511937,The effect of high vs. low intensity neuropsychological treatment on working memory in patients with acquired brain injury.,"AIM To evaluate the combined effect of compensation therapy and functional training on working memory (WM) in patients with acquired injury and chronic cognitive deficits by investigating the dose-response relationship and specificity of transfer effects. RESEARCH DESIGN Double-blind randomized controlled trial. METHODS All patients underwent 4 weeks of compensation therapy in a day-care setting. In addition, they received either 20 sessions of computer-based WM training (n = 11) or attention training (n = 9). Transfer effects on cognition and their functional relevance in daily life were assessed before treatment, after 2 weeks (10 additional training sessions), and after 4 weeks (20 additional training sessions) of therapy. RESULTS The combined treatment led to significant improvements in WM performance, verbal memory, and self-reported changes in daily life. The amount of training was identified to modulate efficacy: Significant improvements showed only in the later training phase. We observed no differences between the two training schemes (WM vs. attentional training). CONCLUSIONS Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.",2020,Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.,"['patients with acquired brain injury', 'patients with acquired injury and chronic cognitive deficits']","['compensation therapy and functional training', 'computer-based WM training (n\xa0=\xa011) or attention training', 'compensation therapy', 'high vs. low intensity neuropsychological treatment']","['working memory (WM', 'cognition and their functional relevance in daily life', 'WM performance, verbal memory, and self-reported changes in daily life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0373474,Even in the chronic phase after brain lesion WM performance can be enhanced by the combination of compensation therapy and computerized cognitive training when applied intensely; both a more general attention and a specific WM training regimen are effective.,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Weicker', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hudl', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences , Leipzig, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Psychology, Carl Von Ossietzky University of Oldenburg , Oldenburg, Germany.'}, {'ForeName': 'Hellmuth', 'Initials': 'H', 'LastName': 'Obrig', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Psychology, Carl Von Ossietzky University of Oldenburg , Oldenburg, Germany.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Thöne-Otto', 'Affiliation': 'Clinic of Cognitive Neurology, University of Leipzig , Leipzig, Germany.'}]",Brain injury,['10.1080/02699052.2020.1773536'] 2134,32511981,"Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND Resistance to approved inhibitors of KIT proto-oncogene, receptor tyrosine kinase (KIT), and platelet-derived growth factor receptor α (PDGFRA) is a clinical challenge for patients with advanced gastrointestinal stromal tumours. We compared the efficacy and safety of ripretinib, a switch-control tyrosine kinase inhibitor active against a broad spectrum of KIT and PDGFRA mutations, with placebo in patients with previously treated, advanced gastrointestinal stromal tumours. METHODS In this double-blind, randomised, placebo-controlled, phase 3 study, we enrolled adult patients in 29 specialised hospitals in 12 countries. We included patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Eligible patients were randomly assigned (2:1) to receive either oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo group). Randomisation was done via an interactive response system using randomly permuted block sizes of six and stratified according to number of previous therapies and ECOG performance status. Patients, investigators, research staff, and the sponsor study team were masked to a patient's treatment allocation until the blinded independent central review (BICR) showed progressive disease for the patient. The primary endpoint was progression-free survival, assessed by BICR. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of study drug. Patients randomly assigned to placebo were permitted to cross over to ripretinib 150 mg at the time of disease progression. The INVICTUS study is registered with ClinicalTrials.gov, number NCT03353753, and with WHO International Clinical Trials Registry Platform, number EUCTR2017-002446-76-ES; follow-up is ongoing. FINDINGS Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients were randomly assigned to receive either ripretinib (n=85) or placebo (n=44). At data cutoff (May 31, 2019), at a median follow-up of 6·3 months (IQR 3·2-8·2) in the ripretinib group and 1·6 months (1·1-2·7) in the placebo group, 51 patients in the ripretinib group and 37 in the placebo group had had progression-free survival events. In the double-blind period, median progression-free survival was 6·3 months (95% CI 4·6-6·9) with ripretinib compared with 1·0 months (0·9-1·7) with placebo (hazard ratio 0·15, 95% CI 0·09-0·25; p<0·0001). The most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events in the ripretinib group (n=85) included lipase increase (four [5%]), hypertension (three [4%]), fatigue (two [2%]), and hypophosphataemia (two (2%]); in the placebo group (n=43), the most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events were anaemia (three [7%]), fatigue (one [2%]), diarrhoea (one [2%]), decreased appetite (one [2%]), dehydration (one [2%]), hyperkalaemia (one [2%]), acute kidney injury (one [2%]), and pulmonary oedema (one [2%]). Treatment-related serious adverse events were reported in eight (9%) of 85 patients who received ripretinib and three (7%) of 43 patients who received placebo. Treatment-related deaths occurred in one patient in the placebo group (septic shock and pulmonary oedema) and one patient in the ripretinib group (cause of death unknown; the patient died during sleep). INTERPRETATION Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. FUNDING Deciphera Pharmaceuticals.",2020,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. ","['enrolled adult patients in 29 specialised hospitals in 12 countries', 'patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments', 'Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients', 'patients with previously treated, advanced gastrointestinal stromal tumours', 'patients with advanced gastrointestinal stromal tumours (INVICTUS', 'patients with advanced gastrointestinal stromal tumours', 'Eligible patients']","['ripretinib', 'oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo', 'placebo']","['lipase increase', 'median progression-free survival', 'progression-free survival events', 'intention-to-treat population and safety', 'fatigue', 'hyperkalaemia', 'acute kidney injury', 'septic shock and pulmonary oedema', 'diarrhoea', 'dehydration', 'serious adverse events', 'pulmonary oedema', 'hypertension', 'deaths', 'decreased appetite', 'progression-free survival, assessed by BICR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.788248,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. ","[{'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France; Headquarters, Unicancer, Paris, France; LYRICAN, Lyon, France; Faculte Lyon Est, Université Claude Bernard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine, Portland VA Health Care System, Portland, OR, USA; OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology and Preventative Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, Essen, Germany; German Consortium for Translational Cancer Research (DKTK), Partner Site Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Leuven Cancer Institute and Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK; Division of Clinical Studies, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30168-6'] 2135,32512056,Ranibizumab in Diabetic Retinopathy with or without Diabetic Macular Edema.,"In these post-hoc analyses of data from the Protocol S study, ranibizumab 0.5 mg produced similar clinically meaningful improvements in eyes with diabetic retinopathy irrespective of diabetic macular edema at baseline.",2020,"In these post-hoc analyses of data from the Protocol S study, ranibizumab 0.5 mg produced similar clinically meaningful improvements in eyes with diabetic retinopathy irrespective of diabetic macular edema at baseline.",['Diabetic Retinopathy with or without Diabetic Macular Edema'],"['Ranibizumab', 'ranibizumab']",['diabetic macular edema'],"[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]",,0.0283317,"In these post-hoc analyses of data from the Protocol S study, ranibizumab 0.5 mg produced similar clinically meaningful improvements in eyes with diabetic retinopathy irrespective of diabetic macular edema at baseline.","[{'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye Ear Nose and Throat Associates, Charlotte, North Carolina. Electronic address: ana@ceenta.com.'}, {'ForeName': 'Kathleen Wade', 'Initials': 'KW', 'LastName': 'Tarnowski', 'Affiliation': 'Genentech, Inc., South San Francisco, California, at the time of the study; Ocular Therapeutix, Inc., Bedford, Massachusetts.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basu', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Ehrlich', 'Affiliation': 'Genentech, Inc., South San Francisco, California, at the time of the study; Kodiak Sciences Inc., Palo Alto, California.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Haskova', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.05.020'] 2136,32512067,Comparison of the biocidal efficacy of sodium dichloroisocyanurate and calcium hydroxide as intra-canal medicaments over a seven-day contact time: an ex-vivo study.,"INTRODUCTION The use of medicaments has been recommended for the treatment of root canal infection. This study evaluated the antimicrobial effect of a well-known biocidal agent, sodium dichloroisocyanurate (NaDCC), by comparing it with calcium hydroxide (Ca(OH) 2 ) using an engineered 3-species biofilm root canal model. METHOD ology: 38 human single-rooted teeth were decoronated and chemo-mechanically prepared before inoculation using Enterococcus faecalis, Actinomyces viscosus, and Streptococcus mutans using a flow-cell model for 4 weeks for biofilm formation. The samples were randomly divided into 3 groups: NaDCC (n=12), Ca(OH) 2 (n=12) and positive control (no medicament) (n=14). The medicaments were placed using a lentulo spiral. After a contact time of 7 days, the roots were crushed, and plated on selective media. Bacterial identities were confirmed with the use of selective media. Colony-forming units (CFU/ml) were calculated. Descriptive statistics [mean and standard deviations (SD)] were calculated. RESULTS 7 days dressing with NaDCC or Ca(OH) 2 presented with no growth. For the positive control CFU/ml mean were 2.97E4 ± 3.42E4. All previously inoculated strains were recovered in the control group. CONCLUSIONS NaDCC and Ca(OH) 2 when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model. NaDCC deserves further investigation as an intracanal medicament.",2020,"CONCLUSIONS NaDCC and Ca(OH) 2 when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.",['ology: 38 human single-rooted teeth'],"['NaDCC or Ca(OH', 'calcium hydroxide (Ca(OH', 'sodium dichloroisocyanurate and calcium hydroxide', 'well-known biocidal agent, sodium dichloroisocyanurate (NaDCC', 'Ca(OH) 2 (n=12) and positive control (no medicament', 'NaDCC']",['Descriptive statistics [mean and standard deviations (SD'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0142834', 'cui_str': 'Sodium dichloroisocyanurate'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.0118599,"CONCLUSIONS NaDCC and Ca(OH) 2 when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.","[{'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Neelika Roy', 'Initials': 'NR', 'LastName': 'Chowdhury', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia; Private practice, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zilm', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Rossi-Fedele', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia. Electronic address: giampiero.rossi-fedele@adelaide.edu.au.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.011'] 2137,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Basic Psychological Research and Research Methods, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Basic Psychological Research and Research Methods, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Basic Psychological Research and Research Methods, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010 Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024'] 2138,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025'] 2139,32507624,Beetroot juice supplementation increases concentric and eccentric muscle power output. Original investigation.,"OBJECTIVES Beetroot juice (BJ) supplementation has been reported to enhance skeletal muscle contractile function; however, it is currently unclear whether BJ supplementation elicits comparable improvements in power output during different types of skeletal muscle contractions. The purpose of the current study was to assess the effect of BJ supplementation on power output during concentric (CON) and eccentric (ECC) muscle contractions during a half-squat. DESIGN In a randomized, double-blind placebo-controlled crossover design, eighteen adult males (age: 22.8±4.9y) completed two experimental testing sessions 2.5h following the acute ingestion of 140mL nitrate-rich BJ concentrate or a placebo. METHODS Each experimental session comprised four sets of eight all-out half-squat repetitions with each set completed with a different moment intertia (0.025, 0.050, 0.075 and 0.100kg·m -2 ). RESULTS Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent. Moreover, comparable increases in peak power output (PP) during the CON (ES: 0.86-1.24) and ECC (ES: 0.6-1.08; all p<0.05) movement phases were observed following BJ supplementation. CONCLUSION Acute BJ supplementation increased mean and peak lower limb power output in the concentric and eccentric movement phases of a half-squat. These findings improve understanding of the effects of BJ supplementation on skeletal muscle contractile function and might have implications for enhancing sports performance in events where muscle power output is a key performance determinant.",2020,"Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent.",['eighteen adult males (age: 22.8±4.9y'],"['140mL nitrate-rich BJ concentrate or a placebo', 'Beetroot juice (BJ) supplementation', 'BJ supplementation', 'placebo, BJ supplementation', 'Beetroot juice supplementation', 'Acute BJ supplementation', 'placebo']","['peak power output (PP', 'mean and peak lower limb power output', 'mean power output (MP', 'concentric and eccentric muscle power output', 'power output during concentric (CON) and eccentric (ECC) muscle contractions']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C1562259', 'cui_str': 'Eccentric muscle contraction'}]",18.0,0.17935,"Compared to placebo, BJ supplementation increased mean power output (MP) during the CON (ES: 0.61-1.01) and ECC (ES: 0.54-0.89; all p<0.05) movement phases to a similar extent.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castillo', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain. Electronic address: danicasti5@gmail.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Raya-González', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Domínguez', 'Affiliation': 'Faculty of Health Sciences, University Isabel I, Spain.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, United Kingdom.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.05.018'] 2140,32507638,A randomized clinical trial in improving pulmonary function and functional capacity in pediatric open abdominal surgery.,"PURPOSE Pulmonary function and functional capacity gets compromised and reduced after open abdominal surgery. We assessed whether Preoperative physiotherapy education (POPE) along with postoperative physiotherapy (POP) preserve pulmonary function and functional capacity after open abdominal surgery among Pediatric population. Hence, the goal of this study was to determine the effectiveness of POPE combined with POP against the standard treatment care of, Postoperative physiotherapy (POP) only in improving pulmonary function and functional capacity in pediatric open abdominal surgery. METHODS Twenty one children aged, 5-17 years old undergoing the open abdominal surgery were randomized to POPE and POP group (Intervention arm 1) and Postoperative physiotherapy group (POP) only group (Intervention arm 2). Primary outcome measure was pulmonary function measured by computerized spirometry. Six minute walk test (6MWT), Ten meter walk test (10mWT), Timed up and go test (TUGT) and Nine stair climbing test (9SCT) were used as secondary outcome measures to measure functional capacity along with chest expansion. Pulmonary function measured by spirometery, 10mWT, TUG and chest expansion were measured 1 day before undergoing abdominal surgery (Pre-OP), post-operative day 1 (POD1) and post-operative day 5 (POD5) while 6MWT and 9SCT were measured only at POD1 and POD5. RESULTS Eighteen children who were undergoing open abdominal surgery completed this trial. No statistical difference were noted in Spirometric parameters from Pre-OP to POD5 in both the groups, they are almost approximate to preoperative values, but from POD1 to POD5, statistical difference were noted in all the Spirometric parameters in Intervention arm 1 as compared to Intervention arm 2. Statistical significant improvement (p < 0.05) were noted in TUGT, 10mWT, 9SCT from Pre-OP to POD5 and from POD1 to POD5 also in Intervention arm 1 as compared to Intervention arm 2. CONCLUSION There is sufficient evidence to confirm that POPE combined with POP might improve pulmonary function and functional capacity in children undergoing open abdominal surgery. TYPE OF STUDY Treatment study. LEVEL OF EVIDENCE Level I.",2020,"Statistical significant improvement (p < 0.05) were noted in TUGT, 10mWT, 9SCT from Pre-OP to POD5 and from POD1 to POD5 also in Intervention arm 1 as compared to Intervention arm 2. ","['Eighteen children who were undergoing open abdominal surgery completed this trial', 'Twenty one children aged, 5-17\u202fyears old undergoing the open abdominal surgery', 'pediatric open abdominal surgery', 'Pediatric population', 'children undergoing open abdominal surgery']","['postoperative physiotherapy (POP', 'POPE and POP group (Intervention arm 1) and Postoperative physiotherapy group (POP', 'Preoperative physiotherapy education (POPE', 'Timed up and go test (TUGT) and Nine stair climbing test (9SCT', 'POPE combined with POP', 'Postoperative physiotherapy (POP']","['pulmonary function and functional capacity', 'Six minute walk test (6MWT), Ten meter walk test (10mWT', 'pulmonary function measured by computerized spirometry', 'Pulmonary function measured by spirometery, 10mWT, TUG and chest expansion', 'POD1 and POD5', 'Spirometric parameters']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430519', 'cui_str': 'Stair-climbing test'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",21.0,0.0712071,"Statistical significant improvement (p < 0.05) were noted in TUGT, 10mWT, 9SCT from Pre-OP to POD5 and from POD1 to POD5 also in Intervention arm 1 as compared to Intervention arm 2. ","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Ambala, Haryana, India. Electronic address: neha_sharma@mmumullana.org.'}, {'ForeName': 'Balija Satya', 'Initials': 'BS', 'LastName': 'Sree', 'Affiliation': 'Department of Pediatric surgery, Maharishi Markandeshwar Institute of Medical science and research, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Ambala, Haryana, India; Department of Pediatric Surgery, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh-249203, Uttarakhand, India.. Electronic address: dr.bsatyasree61@gmail.com.'}, {'ForeName': 'Asir John', 'Initials': 'AJ', 'LastName': 'Samuel', 'Affiliation': 'Department of Pediatric and Neonatal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-133207, Ambala, Haryana, India; Department of Physiotherapy, Maharishi Markandeshwar Medical College and Hospital, Maharishi Markandeshwar University, Kumarhatti-173229, Solan, Himachal Pradesh, India. Electronic address: asirjohnsamuel@mmumullana.org.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.04.007'] 2141,32507672,"Corrigendum to 'Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE)': Annals of Oncology, Volume 31, Issue 1, 2020, Pages 79-87.",,2020,,"['2020, Pages 79-87']","['istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine', 'placebo']",[],"[{'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}]","[{'cui': 'C3641662', 'cui_str': 'MM-141'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0987186,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundranda', 'Affiliation': 'Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Gracian', 'Affiliation': 'Medical Oncology, Centro Integral Oncologico Clara Campal, Universidad CEU San Pablo, Madrid, Spain; Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, Madrid, Spain.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Zafar', 'Affiliation': 'Hematology and Oncology, Florida Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meiri', 'Affiliation': 'Medical Oncology, Comprehensive Care and Research Center, Atlanta, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'TUM School of Medicine, Klinikum rechts der Isar, Medizinische Klinik II, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Ahn', 'Affiliation': 'Medical Oncology, Cancer Treatment Centers of America Chicago, Zion, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Charu', 'Affiliation': 'Hematology/Oncology, Pacific Cancer Medical Center, Anaheim, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zalutskaya', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kuesters', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Pipas', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santillana', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Askoxylakis', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Hematology/Oncology, University of California San Francisco Cancer Center, San Francisco, USA. Electronic address: andrew.ko@ucsf.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.011'] 2142,32507682,"Re: Farha Pirani, Salima S. Makhani, Frances Y. Kim, et al. Prospective Randomized Trial Comparing the Safety and Clarity of Water Versus Saline Irrigant in Ureteroscopy. Eur Urol Focus. In press. https://doi.org/10.1016/j.euf.2020.02.009.",,2020,,[],['Water Versus Saline Irrigant'],[],[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]",[],,0.0300504,,"[{'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Ventimiglia', 'Affiliation': ""Service d'Urologie, AP-HP Hôpital Tenon, Sorbonne Université, Paris, France; Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, Sorbonne Université, Paris, France; Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.""}, {'ForeName': 'Steeve', 'Initials': 'S', 'LastName': 'Doizi', 'Affiliation': ""Service d'Urologie, AP-HP Hôpital Tenon, Sorbonne Université, Paris, France; Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, Sorbonne Université, Paris, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salonia', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': ""Service d'Urologie, AP-HP Hôpital Tenon, Sorbonne Université, Paris, France; Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, Sorbonne Université, Paris, France. Electronic address: olivier.traxer@aphp.fr.""}]",European urology focus,['10.1016/j.euf.2020.04.013'] 2143,32507863,Moxifloxacin versus amoxicillin plus metronidazole as adjunctive therapy for generalized aggressive periodontitis: a pilot randomized controlled clinical trial.,"OBJECTIVE Adjunctive antimicrobials improve probing depth and clinical attachment loss compared with subgingival debridement (SD) alone in patients with aggressive periodontitis. The microbiologic and clinical effectiveness of moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME) as adjunctive therapies for generalized aggressive periodontitis were compared. METHOD AND MATERIALS This pilot randomized controlled clinical trial included 36 patients who were assigned to one of three therapy groups: SD plus systemic MOX (400 mg QD for 7 days), SD plus systemic AMOX+ME (500 mg TID each for 7 days), or SD plus placebo. Probing depth, clinical attachment loss, bleeding on probing, and plaque were recorded at baseline and 3 and 6 months after treatment. Subgingival plaque samples were analyzed. RESULTS All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001). There was a significant reduction in the occurrence of gingival pockets ≥ 6 mm at 6 months in all treatment groups (P < .0001), favoring the MOX and AMOX+ME groups. Adjunctive MOX diminished subgingival Aggregatibacter actinomycetemcomitans to unnoticeable stages, after the follow-up period. Adverse events were noted only in some patients of the AMOX+ME group. CONCLUSIONS This pilot clinical trial proposes that using MOX and AMOX+ME as adjuncts to SD improves the clinical and microbiologic parameters in comparison to mechanical therapy alone; however, the MOX protocol did not cause adverse events and decreased subgingival A actinomycetemcomitans to imperceptible levels.",2020,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","['generalized aggressive periodontitis', '36 patients who were assigned to one of three therapy groups', 'patients with aggressive periodontitis']","['SD plus systemic AMOX+ME', 'subgingival debridement (SD) alone', 'AMOX+ME', 'Moxifloxacin', 'MOX and AMOX+ME', 'amoxicillin plus metronidazole', 'SD plus systemic MOX', 'moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME', 'placebo']","['Adverse events', 'significant probing depth and clinical attachment loss reduction', 'Probing depth, clinical attachment loss, bleeding on probing, and plaque', 'probing depth and clinical attachment loss', 'occurrence of gingival pockets']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0017571', 'cui_str': 'Gingival pocket'}]",36.0,0.171925,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Ardila', 'Affiliation': ''}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Flórez-Flórez', 'Affiliation': ''}, {'ForeName': 'Luis-David', 'Initials': 'LD', 'LastName': 'Castañeda-Parra', 'Affiliation': ''}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Guzmán', 'Affiliation': ''}, {'ForeName': 'Jader A', 'Initials': 'JA', 'LastName': 'Bedoya-García', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44715'] 2144,32507989,[Timing of androgen-deprivation therapy and radical radiotherapy in localized prostate cancer: a phase III randomized controlled trial].,,2020,,['localized prostate cancer'],['androgen-deprivation therapy and radical radiotherapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0915835,,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Nieder', 'Affiliation': 'Dept. of Oncology and Palliative Medicine, Nordland Hospital Trust, P.O. Box 1480, 8092, Bodø, Norwegen. carsten.nieder@nlsh.no.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01645-5'] 2145,32507991,Changes in ocular biomechanics after treatment for active Graves' orbitopathy.,"PURPOSE To evaluate the changes in ocular biomechanical properties in active moderate-to-severe Graves' orbitopathy (GO) after intravenous glucocorticoids (IVGCs), and to clarify correlations between clinical findings and ocular biomechanical properties. METHODS A prospective study. A total of 20 consecutive GO patients and 20 age- and sex-matched healthy control subjects were included. GO was diagnosed on the basis of the recommendation by the European Group on Graves' Orbitopathy (EUGOGO), and disease activity was assessed by the clinical activity score (CAS). Patients were assigned to receive once weekly IVGCs (0.5 g, then 0.25 g, 6 weeks each). All participants received a full ophthalmic examination and biomechanical evaluation was performed with dynamic Scheimpflug analyzer (Corvis ST) at baseline and 12th weeks after therapy. RESULTS The biomechanically corrected intraocular pressure (bIOP) in GO patients was significantly higher than that in healthy subjects. In contrast, the whole eye movement (WEM) in GO patients was significantly lower than in healthy subjects after adjusting for bIOP. The CAS, NOSPECS score, and exophthalmos were significantly positively correlated with the bIOP and negatively correlated with the WEM after adjusting for bIOP, CCT and age. The WEM significantly increased, whereas bIOP significantly decreased after IVGCs (P < 0.001, P = 0.001 respectively). The overall response rate at the 12th week was 85% (17 of 20). CONCLUSIONS The changes of ocular biomechanical properties measured by Corvis ST were an objective indicator of inflammatory activity and severity of GO. Combining CAS and ocular biomechanical properties could better evaluate the therapeutic outcome of active moderate-to-severe GO.",2020,"The WEM significantly increased, whereas bIOP significantly decreased after IVGCs (P < 0.001, P = 0.001 respectively).",['20 consecutive GO patients and 20 age- and sex-matched healthy control subjects were included'],"['IVGCs', 'full ophthalmic examination and biomechanical evaluation was performed with dynamic Scheimpflug analyzer (Corvis ST', 'intravenous glucocorticoids (IVGCs']","['inflammatory activity and severity of GO', 'ocular biomechanics', 'ocular biomechanical properties', 'clinical activity score (CAS', 'overall response rate', 'biomechanically corrected intraocular pressure (bIOP', 'CAS, NOSPECS score, and exophthalmos']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",20.0,0.0181607,"The WEM significantly increased, whereas bIOP significantly decreased after IVGCs (P < 0.001, P = 0.001 respectively).","[{'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Li', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Zhao', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Mu', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Hospital, Tianjin Eye Institute, No 4. Gansu Road, He-ping District, Tianjin, 300020, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Hospital, Tianjin Eye Institute, No 4. Gansu Road, He-ping District, Tianjin, 300020, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China. wangyan7143@vip.sina.com.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01322-5'] 2146,32508043,Randomized trial of a hospice video educational tool for patients with advanced cancer and their caregivers.,"BACKGROUND Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse. METHODS The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use. RESULTS Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P < .001). After the intervention, caregivers assigned to view the video were more likely to prefer hospice for their loved ones (94.4% vs 65.4%; P = .031), reported greater knowledge concerning hospice (9.7% vs 8.0%; P = .001), and were less likely to endorse that hospice is only about death (0.0% vs 23.1%; P = .066). CONCLUSIONS A hospice video did not significantly impact patients' preferences for hospice care. Patients with advanced cancer and their caregivers who were assigned to view the video were more informed regarding hospice and reported more favorable perceptions of hospice. Patients were more likely to use hospice and to have a longer hospice length of stay.",2020,Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010).,"['150 hospitalized patients with advanced cancer and their caregivers', 'Intervention participants (75 patients and 18 caregivers', 'patients with advanced cancer and their caregivers', 'Control participants (75 patients and 26 caregivers', 'Patients without a caregiver were eligible', 'Patients with advanced cancer and their caregivers', 'Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled']","['verbal description identical to the video narrative', '6-minute video depicting hospice', 'video educational tool versus a verbal description of hospice', 'hospice video educational tool']","['hospice length of stay', 'knowledge regarding hospice', 'patient preference for hospice', 'patient and/or caregiver knowledge and perceptions of hospice, and hospice use', 'knowledge concerning hospice', 'longer hospice length of stay']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",150.0,0.102002,Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010).,"[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Vanbenschoten', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Netana', 'Initials': 'N', 'LastName': 'Markovitz', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cashavelly', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lee Ann', 'Initials': 'LA', 'LastName': 'Tata', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Reynolds', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhatt', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fishman', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Horick', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'University of Florida at Gainesville, Gainesville, Florida, USA.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Volandes', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Department of Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Cancer,['10.1002/cncr.32967'] 2147,32508211,The Influence of Evidence-Based Exercise and Age Reattribution on Physical Function in Hispanic Older Adults: Results From the ¡Caminemos! Randomized Controlled Trial.,"Older Hispanics routinely exhibit unhealthy beliefs about ""normal"" aging trajectories, particularly related to exercise and physical function. We evaluated the prospective effects of age reattribution on physical function in older Hispanics. Participants ( n = 565, ≥60 years) were randomly assigned into (a) treatment group-attribution-retraining, or (b) control group-health education. Each group separately engaged in four weekly 1-hr group discussions and 1-hr exercise classes, followed by monthly maintenance sessions. The Short Physical Performance Battery (SPPB) measured physical function throughout the 24-month intervention. No significant difference in physical function between intervention arms was evident over time. However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]). Participating in the exercise intervention was associated with improvements in physical function, although no additional gains were apparent for age attribution-retraining. Future research should consider strengthening or modifying intervention content for age reattribution or dosage received.",2020,"However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]).","['older Hispanics', 'Participants ( n = 565, ≥60 years', 'Older Hispanics', 'Hispanic Older Adults']","['exercise intervention', 'treatment group-attribution-retraining, or (b) control group-health education', 'Evidence-Based Exercise and Age Reattribution']","['physical function', 'Short Physical Performance Battery (SPPB) measured physical function']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0233899,"However, both groups experienced significant improvements in physical function at 24 months (β = 0.43, 95% confidence interval [CI] = [0.16, 0.70]).","[{'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Burrows', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Flavia Cristina Drumond', 'Initials': 'FCD', 'LastName': 'Andrade', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Lissette', 'Initials': 'L', 'LastName': 'Piedra', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Aguiñaga', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Nessa', 'Initials': 'N', 'LastName': 'Steinberg', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sarkisian', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820927171'] 2148,32508218,The Effects of Algebraic Equation Solving Intervention for Students With Mathematics Learning Difficulties.,"The purpose of this study was to examine the effects of algebraic equation solving intervention for sixth graders with mathematics learning difficulties (MD). A total of 48 students with MD were randomly assigned to either the algebraic equation solving intervention, Mystery Math ( n = 24) or control condition ( n = 24). The multicomponent intervention was based on the principles of explicit instruction and focused on improving conceptual and procedural knowledge of algebraic equation solving using concrete manipulatives. Students in the intervention group received instruction in pairs, 30 min per session, 3 sessions per week for 5 weeks (i.e., 15 sessions). The results indicated that the main effect of intervention was significant for 2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving with large effect sizes. However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations. The findings demonstrate that grade-level standards can be successfully taught to students with MD. Implications for practice are discussed.",2020,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","['sixth graders with mathematics learning difficulties (MD', 'Students With Mathematics Learning Difficulties', '48 students with MD']","['Algebraic Equation Solving Intervention', 'algebraic equation solving intervention, Mystery Math ( n = 24) or control condition', 'algebraic equation solving intervention']","['2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0424939', 'cui_str': 'Learning difficulties'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",48.0,0.0172868,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Namkung', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bricko', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}]",Journal of learning disabilities,['10.1177/0022219420930814'] 2149,32508221,Acute ingestion of beetroot juice does not improve short-duration repeated sprint running performance in male team sport athletes.,"The effects of acute ingestion of nitrate on short-duration repeated sprint performance (RSP) are unclear. This study investigated the effect of acute ingestion of beetroot juice on a test of RSP in team sport athletes. Sixteen male team sport athletes undertook four trials using a 40 m maximum shuttle run test (MST), which incorporates 10 × 40 m shuttle sprints with 30 s between the start of each sprint. Two familiarisation trials, followed by nitrate-rich beetroot juice (BR; ~6 mmol nitrate) and nitrate-depleted beetroot juice (PLA; ~0.0034 mmol nitrate) trials were completed in a randomised, double-blind manner. Ingestion of beetroot juice 3 h prior to exercise elevated plasma nitrate concentrations ~6-fold in BR (BR, 413 ± 56 μM; PLA, 69 ± 30 μM; P < 0.001). RSP, assessed by sprint performance decrement (S dec ; %), did not differ (P = 0.337) between BR (5.31 ± 2.49%) and PLA (5.71 ± 2.61%). There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109). Therefore, acute ingestion of beetroot juice did not improve a test of short-duration RSP in team sport athletes.",2020,"There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109).","['male team sport athletes', 'Sixteen male team sport athletes', 'team sport athletes']","['nitrate-rich beetroot juice (BR; ~6\xa0mmol nitrate) and nitrate-depleted beetroot juice (PLA; ~0.0034\xa0mmol nitrate', '40 m maximum shuttle run test (MST', 'beetroot juice']","['total sprint time', 'slowest sprint', 'post-exercise blood lactate concentration', 'sprint performance decrement', 'fastest sprint']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",16.0,0.220199,"There was no difference between trials for total sprint time (P = 0.806), fastest sprint (P = 0.341), slowest sprint (P = 0.787), or post-exercise blood lactate concentration (BR, 11.8 ± 2.5 mM; PLA, 12.2 ± 2.3 mM; P = 0.109).","[{'ForeName': 'Ciara M E', 'Initials': 'CME', 'LastName': 'Reynolds', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Halpenny', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Caoimhe', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jordan', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Quinn', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hone', 'Affiliation': 'School of Health and Human Performance, Dublin City University , Dublin, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'UCD Institute for Sport & Health, School of Public Health, Physiotherapy, and Sports Science, University College Dublin , Dublin, Ireland.'}]",Journal of sports sciences,['10.1080/02640414.2020.1770409'] 2150,32508270,The Influence of Gender on Perceptions of Culpability and Victim Status in Statutory Rape Offenses Involving Teachers.,"Perceptions of child sexual abuse and statutory rape vary based on the gender of the victim, the perpetrator, and the combination of both. We extend existing research to examine attributions of responsibility and punitive preferences for student victims in student-teacher sexual relationships contingent on the gender dyad of the student and teacher and the interaction between the gender dyad and respondent gender. Participants ( N = 648) were randomly assigned to vignettes wherein the gender of the student and teacher were manipulated (female teacher/male student; female teacher/female student; male teacher/female student; male teacher/male student). Overall, respondents were ""pro-victim,"" though results indicate significant differences in respondent gender and how the gender dyads were perceived. Students in the male same-sex dyads were attributed less responsibility than other students. Furthermore, men were less likely to perceive the student as a victim, and women were more likely to indicate the student should be punished.",2020,"Overall, respondents were ""pro-victim,"" though results indicate significant differences in respondent gender and how the gender dyads were perceived.","['Participants ( N = 648) were randomly assigned to vignettes wherein the gender of the student and teacher were manipulated (female teacher/male student; female teacher/female student; male teacher/female student; male teacher/male student', 'Students in the male same-sex dyads']",[],[],"[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],[],648.0,0.0206259,"Overall, respondents were ""pro-victim,"" though results indicate significant differences in respondent gender and how the gender dyads were perceived.","[{'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Muniz', 'Affiliation': 'The University of Texas at El Paso, USA.'}, {'ForeName': 'Ráchael A', 'Initials': 'RA', 'LastName': 'Powers', 'Affiliation': 'University of South Florida, Tampa, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Leili', 'Affiliation': 'Rhodes College, Memphis, USA.'}]",Sexual abuse : a journal of research and treatment,['10.1177/1079063220928955'] 2151,32508277,"A randomized controlled pilot study evaluating Worry Less, Live More: The Mindful Way Through Anxiety Workbook .","Effective interventions for generalized anxiety exist, but barriers to treatment prevent their broad dissemination. Commercially available self-help materials may help bridge this gap, but few have been empirically evaluated. This study compared self-reported change in generalized anxiety symptomology and associated problems between community members with excessive worry who were randomly assigned to receive the Worry Less, Live More: The Mindful Way through Anxiety Workbook ( n = 35) and those in a delayed condition ( n = 29). Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η 2 =.15), general anxiety/tension ( η 2 =.13), and anxiety ( η 2 =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected. This pilot study provides support for continued research examining the efficacy of acceptance-based behavioral therapy delivered in a self-help format.",2020,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η 2 =.15), general anxiety/tension ( η 2 =.13), and anxiety ( η 2 =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","['community members with excessive worry', 'Worry Less, Live More']",['acceptance-based behavioral therapy'],"['depression, functional impairment or acceptance', 'generalized anxiety symptomology', 'general anxiety/tension', 'anxiety']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",,0.0306532,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η 2 =.15), general anxiety/tension ( η 2 =.13), and anxiety ( η 2 =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, Department of Psychiatry, Yale University School of Medicine , New Haven, CT, USA.'}, {'ForeName': 'Lizabeth', 'Initials': 'L', 'LastName': 'Roemer', 'Affiliation': 'Psychology Department, University of Massachusetts , Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Suvak', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Liverant', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Orsillo', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1765858'] 2152,32508281,Mindfulness Predicts Psycho-behavioral Improvement after Breast Cancer Diagnosis: Influence of Childhood Adversity.,"Mindfulness-based interventions provide psychological benefit after breast cancer diagnosis. The aims of this study were to determine whether within-person change in facets of mindfulness predict psycho-behavioral improvements in women with breast cancer, and to assess the influence of childhood adversity on those improvements. Women randomized to the mindfulness arm of a larger trial were evaluated. Psychometric instruments and the Five Facets of Mindfulness Questionnaire were completed pre-, mid-, at completion, one, and six months post program. A subsample completed the Childhood Trauma Questionnaire. Hierarchical linear modeling revealed that significant change in nonjudgment and nonreactivity to inner experience were associated with more rapid decrease in stress, depressive symptoms, fatigue, sleep disturbance, and more rapid increase in quality of life. For women with greater exposure to childhood adversity, a greater increase in nonreactivity to inner experience significantly associated with greater improvements in stress, depressive symptoms, and quality of life.",2020,"Hierarchical linear modeling revealed that significant change in nonjudgment and nonreactivity to inner experience were associated with more rapid decrease in stress, depressive symptoms, fatigue, sleep disturbance, and more rapid increase in quality of life.","['after Breast Cancer Diagnosis', 'women with breast cancer']",[],"['quality of life', 'Childhood Trauma Questionnaire', 'stress, depressive symptoms, and quality of life', 'Mindfulness Predicts Psycho-behavioral Improvement', 'stress, depressive symptoms, fatigue, sleep disturbance']","[{'cui': 'C0678222', 'cui_str': 'Carcinoma of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",,0.0237427,"Hierarchical linear modeling revealed that significant change in nonjudgment and nonreactivity to inner experience were associated with more rapid decrease in stress, depressive symptoms, fatigue, sleep disturbance, and more rapid increase in quality of life.","[{'ForeName': 'Linda Witek', 'Initials': 'LW', 'LastName': 'Janusek', 'Affiliation': 'Department of Health Promotion, Marcella Niehoff School of Nursing, Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Tell', 'Affiliation': 'Department of Health Promotion, Marcella Niehoff School of Nursing, Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Mathews', 'Affiliation': 'Department of Microbiology and Immunology, Stritch School of Medicine, Loyola University Chicago, Maywood, IL, USA.'}]",Western journal of nursing research,['10.1177/0193945920932290'] 2153,32508297,Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial - Corrigendum.,,2020,,['women with polycystic ovary syndrome'],"['synbiotic supplementation', 'placebo']",['metabolic parameters and apelin'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3542402', 'cui_str': 'Apelin'}]",,0.796448,,"[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi', 'Affiliation': ''}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': ''}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Shirzad', 'Affiliation': ''}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': ''}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Hossein-Boroujerdi', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Javad Hosseinzadeh-Attar', 'Affiliation': ''}]",The British journal of nutrition,['10.1017/S0007114520001488'] 2154,32508318,Eight-gene signature predicts recurrence in lung adenocarcinoma.,"Recurrence significantly influences the survival in lung patients with adenocarcinoma (LUAD). However, there are less gene signatures that predict recurrence risk of LUAD. We performed this study to construct a model to predict risk of recurrence in LUAD. RNA-seq data from 426 patients with LUAD were downloaded from The Cancer Genome Atlas (TCGA) and were randomly assigned into the training (n= 213) and validation set (n= 213). Differentially expressed genes (DEGs) between recurrent and non-recurrent tumors in the training set were identified. Recurrence-associated DEGs were selected using multivariate Cox regression analysis. The recurrence risk model that identifies patients at low and high risk for recurrence was constructed, followed by the validation of its performance in the validation set and a microarray dataset. Totally, 378 DEGs, including 20 recurrence-associated DEGs were identified between the recurrent and non-recurrent tumors in the training set. The signatures of 8 genes (including AZGP1, INPP5J, MYBPH, SPIB, GUCA2A, HTR1B, SLC15A1 and TNFSF11) were used to construct the prognostic model to assess the risk of recurrence. This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores. ROC curve analysis of this model showed it had high predictive accuracy (AUC > 0.8) to predict LUAD recurrence in the TCGA cohort (the training and validation sets) and GSE50081 dataset. This prognostic model showed high predictive power and performance in predicting recurrence in LUAD. We concluded that this model might be of great value for evaluating the risk of recurrence of LUAD in clinics.",2020,This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores.,"['lung patients with adenocarcinoma (LUAD', '426 patients with LUAD were downloaded from The Cancer Genome Atlas (TCGA', 'lung adenocarcinoma']",[],"['20 recurrence-associated DEGs', 'recurrence-free survival time', 'LUAD recurrence']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}]",[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2919551', 'cui_str': 'Duration of recurrence-free survival'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]",426.0,0.0320685,This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores.,"[{'ForeName': 'Yongjian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology Radiology, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Koujun', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}]",Cancer biomarkers : section A of Disease markers,['10.3233/CBM-190329'] 2155,32508323,Volume Analysis of Brain Cognitive Areas in Alzheimer's Disease: Interim 3-Year Results from the ASCOMALVA Trial.,"BACKGROUND Cerebral atrophy is a common feature of several neurodegenerative disorders, including Alzheimer's disease (AD). In AD, brain atrophy is associated with loss of gyri and sulci in the temporal and parietal lobes, and in parts of the frontal cortex and cingulate gyrus. OBJECTIVE The ASCOMALVA trial has assessed, in addition to neuropsychological analysis, whether the addition of the cholinergic precursor choline alphoscerate to treatment with donepezil has an effect on brain volume loss in patients affected by AD associated with cerebrovascular injury. METHODS 56 participants to the randomized, placebo-controlled, double-blind ASCOMALVA trial were assigned to donepezil + placebo (D + P) or donepezil + choline alphoscerate (D + CA) treatments and underwent brain magnetic resonance imaging and neuropsychological tests every year for 4 years. An interim analysis of 3-year MRI data was performed by voxel morphometry techniques. RESULTS The D + P group (n = 27) developed atrophy of the gray and white matter with concomitant increase in ventricular space volume. In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala. These morphological data are consistent with the results of the neuropsychological tests. CONCLUSION Our findings indicate that the addition of choline alphoscerate to standard treatment with the cholinesterase inhibitor donepezil counters to some extent the loss in volume occurring in some brain areas of AD patients. The observation of parallel less pronounced decrease in cognitive and functional tests in patients with the same treatment suggests that the morphological changes observed may have functional relevance.",2020,"In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala.","['patients affected by AD associated with cerebrovascular injury', '56 participants to the randomized', ""Alzheimer's Disease""]","['donepezil\u200a+\u200aplacebo (D\u200a+\u200aP) or donepezil\u200a+\u200acholine alphoscerate (D\u200a+\u200aCA) treatments and underwent brain magnetic resonance imaging and neuropsychological tests', 'donepezil', 'placebo']","['ventricular space volume', 'cognitive and functional tests', 'brain volume loss', 'gray matter atrophy']","[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017889', 'cui_str': 'choline alfoscerate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]",56.0,0.228653,"In the D + CA group (n = 29) the gray matter atrophy was less pronounced compared to the D + P group in frontal and temporal lobes, hippocampus, and amygdala.","[{'ForeName': 'Enea', 'Initials': 'E', 'LastName': 'Traini', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carotenuto', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}, {'ForeName': 'Angiola Maria', 'Initials': 'AM', 'LastName': 'Fasanaro', 'Affiliation': 'Neurology Unit, National Hospital ""A. Cardarelli"", Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Amenta', 'Affiliation': 'Clinical Research, Telemedicine and Telepharmacy Centre, University of Camerino, Camerino, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190623'] 2156,32508327,"Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease.","BACKGROUND Open-HART was an open-label extension of HART, a randomized, double-blind, placebo-controlled study of pridopidine in Huntington disease (HD). Previously, we reported safety and exploratory efficacy data after 36 months of treatment with pridopidine 45 mg twice daily. In the interim, emerging data suggests pridopidine may have neuroprotective effects mediated by sigma-1 receptor agonism. OBJECTIVE To report additional safety and exploratory efficacy data for continued open-label use of 45 mg BID pridopidine at 48 and 60 months. METHODS Patients in Open-HART were followed up to or greater than 60 months. Adverse events, concomitant medications, vital signs, laboratory values, and ECG data were monitored. Rates of decline in total functional capacity (TFC) and total motor score (TMS) over 60 months were evaluated in an exploratory analysis and compared between Open-HART and placebo recipients from the 2CARE trial. To account for missing data, sensitivity analyses were performed. RESULTS Of the original Open-HART baseline cohort (N = 118), 40 remained in the study at 48 months and 33 at 60 months. Pridopidine remained safe and well tolerated over the 60-month interval. TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial. TFC differences at 48 and 60 months observed remained nominally significant after sensitivity analysis. CONCLUSION The 45 mg BID pridopidine dosage remained safe and tolerable over 60 months. Exploratory analyses show TFC and TMS stability at 48 and 60 months, in contrast to placebo historical controls from the 2CARE trial. Results are consistent with data reported from the recent Phase 2 PRIDE-HD trial showing less functional decline in the pridopidine 45 mg BID treated group at 52 weeks.",2020,"TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial.","['Huntington disease (HD', 'N\u200a=\u200a118', 'Patients in Open-HART were followed up to or greater than 60 months', 'in Huntington Disease']","['TFC and TMS', '45\u200amg BID pridopidine', 'pridopidine', 'Pridopidine', 'placebo']","['TFC and TMS stability', 'total functional capacity (TFC) and total motor score (TMS', 'safe and well tolerated', 'TFC differences', 'Adverse events, concomitant medications, vital signs, laboratory values, and ECG data']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C1741584', 'cui_str': 'pridopidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",,0.101185,"TFC and TMS at 48 and 60 months remained stable, showing less decline at these timepoints compared to historical placebo controls from the 2CARE trial.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Cooper University Health Care at Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kieburtz', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Geva', 'Affiliation': 'Prielnia Therapeutics, Herzliya, Israel.'}, {'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Mehra', 'Affiliation': 'Tigermed Data Solutions, Bengaluru, Karnataka, IN, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Abler', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Grachev', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Mark Forrest', 'Initials': 'MF', 'LastName': 'Gordon', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Juha-Matti', 'Initials': 'JM', 'LastName': 'Savola', 'Affiliation': 'Teva Pharmaceuticals International GmbH, Basel, Switzerland.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gandhi', 'Affiliation': 'Teva Pharmaceutical Industries, Kansas City, MO, USA.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Papapetropoulos', 'Affiliation': 'Teva Pharmaceutical Industries, Frazer, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayden', 'Affiliation': 'Prielnia Therapeutics, Herzliya, Israel.'}]",Journal of Huntington's disease,['10.3233/JHD-190393'] 2157,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143'] 2158,32512380,Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial.,"BACKGROUND To evaluate the efficacy of continuous wound infiltration with ropivacaine to reduce acute postoperative pain in patients undergoing mastectomy for carcinoma of the breast. MATERIALS AND METHODS A randomized, double-blind, placebo-controlled trial was conducted. One hundred fifty patients were randomly assigned to receive continuous ropivacaine (0.2%) (group A, n = 74) or saline solution (0.9%) (group B, n = 76) at 10 mL/h for 48 h through a multilumen catheter placed during the surgical procedure. Postoperative morphine consumption and visual analog scale (VAS) pain scores were recorded. A quality of life score (Quality of life questionnaire Core 30) and a VAS score were obtained at 1, 3, and 6 mo after surgery. RESULTS The difference in mean morphine consumption between the two groups was close to significance during the first 48 h postsurgery (P = 0.056; 10.8 ± 16.5 versus 4.8 ± 10.4 mg). At day 1, patients in the ropivacaine-infusion group had lower morphine consumption than the control group (P = 0.0026). The link between local ropivacaine infiltration and a decrease in mean postoperative VAS scores reached significance for the first 24 h postsurgery (P = 0.039). No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo. CONCLUSIONS Continuous wound infiltration with ropivacaine is efficacious in reducing postoperative pain. Quality of life and chronic pain at 1, 3, and 6 mo were not improved by ropivacaine wound infiltration.",2020,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo. ","['patients undergoing mastectomy for carcinoma of the breast', 'One hundred fifty patients']","['ropivacaine-infusion', 'ropivacaine', 'Mastectomy', 'saline solution', 'continuous ropivacaine', 'Ropivacaine', 'placebo']","['Quality of life and chronic pain', 'acute postoperative pain', 'A quality of life score (Quality of life questionnaire Core 30) and a VAS score', 'postoperative pain', 'mean morphine consumption', 'mean postoperative VAS scores', 'morphine consumption', 'quality of life (overall QLQ-C30 score', 'VAS pain scores', 'Postoperative morphine consumption and visual analog scale (VAS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0238033', 'cui_str': 'Carcinoma of male breast'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",150.0,0.396965,"No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo. ","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beguinot', 'Affiliation': ""Département d'oncologie, Médipôle Hôpital Mutualiste Lyon Villeurbanne, Villeurbanne, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Monrigal', 'Affiliation': 'Département de Chirurgie Sénologique, Montpellier Institut du Sein, Clinique Clémentville, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': 'Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Angeline', 'Initials': 'A', 'LastName': 'Ginzac', 'Affiliation': ""Délégation Recherche Clinique & Innovation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France; Université Clermont Auvergne, Centre Jean Perrin, INSERM, U1240 Imagerie Moléculaire et Stratégies Théranostiques, Clermont-Ferrand, France; Centre d'Investigation Clinique, UMR501, Clermont-Ferrand, France. Electronic address: Angeline.ginzac@clermont.unicancer.fr.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Joly', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Gayraud', 'Affiliation': ""Département d'anesthésie-réanimation, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Le Bouedec', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gimbergues', 'Affiliation': 'Département de Chirurgie Oncologique, Centre Jean Perrin, Centre de Lutte contre le Cancer, Clermont-Ferrand, France.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.006'] 2159,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG). METHODS Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test. RESULTS Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05). CONCLUSIONS It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572'] 2160,32512498,"Assessing the effectiveness of a pediatrician-led newborn parenting class on maternal newborn-care knowledge, confidence and anxiety: A quasi-randomized controlled trial.","BACKGROUND The postpartum hospital stay is a unique opportunity for clinicians to educate parents on the importance of promoting early child development. Pediatricians are well-positioned to address both medical and developmental concerns during critical periods of development, yet very few parenting interventions are led by pediatricians. AIMS To assess the impact of a novel one-hour long pediatrician-led Newborn Class on maternal knowledge, confidence, and anxiety. METHODS We conducted a quasi-randomized controlled trial to evaluate the effectiveness of the Newborn Class. First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited. Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls. OUTCOME MEASURES Maternal self-perceived parental confidence and anxiety were measured using standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD)]. Knowledge on newborn care was assessed using a novel scale. RESULTS A total of 84 participants (intervention n = 36, control n = 48) were included in the study. Mothers who attended the class showed significantly higher levels of knowledge compared to the control group (Knowledge test, Two-tailed t-test, mean [SD], 8.08 [1.06] vs 6.78 [1.25]; P<0.001) as well as significantly higher parenting confidence levels (KPCS, Two-tailed t-test, mean [SD], 39.31 [3.88] vs 35.20 [3.99]; P<0.001). No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164). CONCLUSIONS A short pediatrician-led parenting intervention may be an effective tool in improving maternal confidence and newborn care knowledge. Given the importance of the newborn period in establishing healthy developmental trajectories, there is a crucial need for cost- and time-effective intervention that can be widely implemented to promote parental knowledge and confidence with the ultimate goal of fostering healthy development in children.",2020,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164). ","['Mothers who expressed a desire to attend the class but were discharged before a class was offered served as controls', 'First-time mothers who delivered a full-term singleton vaginally with no major complications and attended the class were recruited', '84 participants (intervention n\xa0=\xa036, control n\xa0=\xa048) were included in the study']","['pediatrician-led newborn parenting class', 'novel one-hour long pediatrician-led Newborn Class', 'Newborn Class']","['maternal knowledge, confidence, and anxiety', 'levels of knowledge', 'standardized scales [Karitane Parenting Confidence Scale (KPCS) and State-Trait Anxiety Inventory for Adults (STAI-AD', 'overall level of anxiety (STAI-AD', 'Maternal self-perceived parental confidence and anxiety', 'parenting confidence levels (KPCS', 'maternal newborn-care knowledge, confidence and anxiety']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}]",84.0,0.0881763,"No change was observed in the overall level of anxiety (STAI-AD, Two-tailed t-test, mean [SD], 35.50 [8.73] vs 38.5 [9.53]; P=0.164). ","[{'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Gozali', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: ag3827@columbia.edu.'}, {'ForeName': 'Sherika', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: sherikagibson95@gmail.com.'}, {'ForeName': 'Lianna R', 'Initials': 'LR', 'LastName': 'Lipton', 'Affiliation': ""Boston Children's Hospital, Department of Pediatrics - Division of Developmental Medicine, 300 Longwood Avenue, Boston, MA 02115, United States. Electronic address: lianna.lipton@childrens.harvard.edu.""}, {'ForeName': 'Aliza W', 'Initials': 'AW', 'LastName': 'Pressman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: aliza.pressman@gmail.com.'}, {'ForeName': 'Blair S', 'Initials': 'BS', 'LastName': 'Hammond', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States. Electronic address: blair.hammond@mssm.edu.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Dumitriu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Pediatrics, One Gustave L. Levy Place, New York, NY 10029, United States; Columbia University Irving Medical Center, Departments of Pediatrics and Psychiatry, Pardes Rm 4932, 1051 Riverside Drive, New York, NY 10032, United States. Electronic address: dani.dumitriu@columbia.edu.'}]",Early human development,['10.1016/j.earlhumdev.2020.105082'] 2161,32512690,Attentiveness and Fidgeting While Using a Stand-Biased Desk in Elementary School Children.,"Standing desks are a viable option to decrease sedentary time in the classroom. However, it is important that standing desks are not detrimental to classroom behavior or learning. The purpose of this study was to evaluate the impact of stand-biased desks on fidgeting and attentiveness. Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study. The intervention employed a within-classroom crossover design, with teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks. Direct observation of student's attentive and fidgeting behaviors occurred at three assessment periods, at baseline when all students were in a sitting desk condition and at the end of each nine-week intervention. Stand-biased desks did not influence fidgeting behavior, but did have an impact on attentive behavior. Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention. While fidgeting and non-attentive episodes ( p = 0.034) were significantly related, the type of desk did not significantly moderate this relationship ( p = 0.810). Standing desks can be incorporated into the classroom without negatively influencing classroom behavior.",2020,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"['Elementary School Children', 'Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study']",['teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks'],"['Attentiveness and Fidgeting', 'sedentary time']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0424235', 'cui_str': 'Fidgeting'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.0251875,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Tokarek', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Lisdahl', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Chi C', 'Initials': 'CC', 'LastName': 'Cho', 'Affiliation': 'Center for Aging and Translational Research, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113976'] 2162,32512691,Daily School Physical Activity Improves Academic Performance.,"Physical activity (PA) may improve brain development, cognition, concentration and academic performance. In this prospective controlled intervention study, we increased the level of PA in 338 children aged 6-8 years at study start, from the Swedish standard of 60 min per week to 200 min per week (40 min daily). The intervention continued in all nine compulsory school years until the students graduated between 2007-2012. All other 689,881 Swedish children who graduated the same years were included as a control group. We registered at graduation eligibility rate for upper secondary school and the final grade score (from 0 to 320 grade points). We also registered the same end points in the 295 students in the index school and in all other 471,926 Swedish students who graduated in 2003-2006, that is, those who graduated before the intervention study started. Before the intervention, academic performance was similar among children in the index school as for all other Swedish boys and girls. With the intervention, the eligibility rate increased for boys in the index school by 7.3 percentage points and the mean grade scores by 13.3 points. This should be compared with a decrease of 0.8 percentage points in eligibility rate and an increase by 2.7 points in grade score in other Swedish boys. No changes were seen for intervention girls, neither in eligibility rates or grade scores. By introducing daily school-based PA in compulsory school, more boys would probably reach the eligibility rate for higher education.",2020,"No changes were seen for intervention girls, neither in eligibility rates or grade scores.","['689,881 Swedish children who graduated the same years were included as a control group', '338 children aged 6-8 years at study start, from the Swedish standard of 60 min per week to 200 min per week (40 min daily', '295 students in the index school and in all other 471,926 Swedish students who graduated in 2003-2006, that is, those who graduated before the intervention study started']",['Physical activity (PA'],"['eligibility rate', 'Daily School Physical Activity Improves Academic Performance', 'eligibility rates or grade scores', 'academic performance', 'brain development, cognition, concentration and academic performance']","[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",689881.0,0.0199294,"No changes were seen for intervention girls, neither in eligibility rates or grade scores.","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Fritz', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Lund University, 20502 Malmö, Sweden.'}, {'ForeName': 'Marcus E', 'Initials': 'ME', 'LastName': 'Cöster', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Lund University, 20502 Malmö, Sweden.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Rosengren', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Lund University, 20502 Malmö, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Karlsson', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Lund University, 20502 Malmö, Sweden.'}, {'ForeName': 'Magnus K', 'Initials': 'MK', 'LastName': 'Karlsson', 'Affiliation': 'Clinical and Molecular Osteoporosis Research Unit, Department of Orthopedics and Clinical Sciences, Lund University, 20502 Malmö, Sweden.'}]","Sports (Basel, Switzerland)",['10.3390/sports8060083'] 2163,32512710,"Effect of Porcine Placenta Extract Supplement on Skin Condition in Healthy Adult Women: A Randomized, Double-Blind Placebo-Controlled Study.","Placenta extract has been used as a component of ointments for skin dryness and beautification. However, little is known about the effect of oral intake of placenta extract on skin condition. The current study aimed to clinically explore the effect of oral intake of porcine placenta extract on human skin quality. A randomized controlled double-blind trial was performed on healthy women aged 40-59 years (n = 20), who were randomly assigned to receive either placebo or 200 mg of porcine placenta extract once daily for 4 weeks from 28 January 2019 to 25 February 2019. Skin quality parameters and the Simplified Menopausal Index (SMI) were assessed at baseline and after 4 weeks. After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group. These results suggest that porcine placenta extract can be used as a health food ingredient to maintain humans' skin condition in the dry winter season.",2020,"After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group.","['healthy women aged 40-59 years (n = 20', 'Healthy Adult Women']","['Placebo', 'placebo or 200 mg of porcine placenta extract', 'Porcine Placenta Extract Supplement', 'porcine placenta extract', 'Placenta extract', 'placebo']","['human skin quality', 'Skin quality parameters and the Simplified Menopausal Index (SMI', 'Skin Condition', 'skin quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]",,0.422736,"After 4 weeks, three parameters of skin quality were significantly improved in the porcine placenta group compared with the placebo group.","[{'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Nagae', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yamakawa', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Matsuki', 'Affiliation': 'Healthcare Business Unit, Kasyu Industries Co., Ltd., 2-5-3 Minami-Futajima, Wakamatsu-ku, Kitakyusyu, Fukuoka 808-0109, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ohnuki', 'Affiliation': 'Department of Biological and Environmental Chemistry, Kinki University Kyushu, Kayanomori, Izuka, Fukuoka 820-8555, Japan.'}, {'ForeName': 'Kuniyoshi', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Faculty of Agriculture, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan.'}]",Nutrients,['10.3390/nu12061671'] 2164,32512752,The Effect of Three Mediterranean Diets on Remnant Cholesterol and Non-Alcoholic Fatty Liver Disease: A Secondary Analysis.,"BACKGROUND Elevated fasting remnant cholesterol (REM-C) levels have been associated with an increased cardiovascular risk in patients with metabolic syndrome (Mets) and Non-Alcoholic Fatty Liver Disease (NAFLD). We aimed to estimate the effect of different diets on REM-C levels in patients with MetS, as well as the association between NAFLD and REM-C. METHODS This is a secondary analysis of the MEDIDIET study, a parallel-arm Randomized Clinical Trial (RCT). We examined 237 people with MetS who underwent Liver Ultrasound (LUS) to assess the NAFLD score at baseline, 3-, and 6-months follow-up. Subjects were randomly assigned to the Mediterranean diet (MD), Low Glycemic Index diet (LGID), or Low Glycemic Index Mediterranean diet (LGIMD). REM-C was calculated as [total cholesterol-low density lipoprotein cholesterol (LDL-C)-high density lipoprotein cholesterol (HDL-C)]. RESULTS REM-C levels were higher in subjects with moderate or severe NAFLD than in mild or absent ones. All diets had a direct effect in lowering the levels of REM-C after 3 and 6 months of intervention. In adherents subjects, this effect was stronger among LGIMD as compared to the control group. There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months. CONCLUSIONS fasting REM-C level is independently associated with the grade of severity of NAFLD. LGIMD adherence directly reduced the fasting REM-C in patients with MetS.",2020,"There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months. ","['237 people with MetS who underwent', 'Remnant Cholesterol and Non-Alcoholic Fatty Liver Disease', 'patients with metabolic syndrome (Mets) and Non-Alcoholic Fatty Liver Disease (NAFLD', 'patients with MetS']","['Liver Ultrasound (LUS', 'Mediterranean diet (MD), Low Glycemic Index diet (LGID), or Low Glycemic Index Mediterranean diet (LGIMD', 'Three Mediterranean Diets']","['total cholesterol-low density lipoprotein cholesterol (LDL-C)-high density lipoprotein cholesterol (HDL-C', 'LGIMD adherence', 'REM-C levels', 'NAFLD score', 'levels of REM-C', 'fasting REM-C']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0412534', 'cui_str': 'Ultrasonography of liver'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",237.0,0.0442918,"There was also a significant increase in REM-C levels among Severe NAFLD subjects at 3 months and a decrease at 6 months. ","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Campanella', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Palma A', 'Initials': 'PA', 'LastName': 'Iacovazzi', 'Affiliation': 'Department of Clinical Pathology, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Misciagna', 'Affiliation': 'Scientific and Ethical Committee, University Hospital Policlinico, 70124 Bari, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Bonfiglio', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mirizzi', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Franco', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sorino', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Caruso', 'Affiliation': 'Ambulatory of Clinical Nutrition, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Cisternino', 'Affiliation': 'Ambulatory of Clinical Nutrition, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buongiorno', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Liuzzi', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}, {'ForeName': 'Alberto R', 'Initials': 'AR', 'LastName': 'Osella', 'Affiliation': 'Laboratory of Epidemiology and Biostatistics, National Institute of Gastroenterology, ""S. de Bellis"" Research Hospital, Castellana Grotte (Bari), Via Turi 27, 70013 Castellana Grotte, Italy.'}]",Nutrients,['10.3390/nu12061674'] 2165,32513049,Effectiveness of the transcutaneous tibial nerve stimulation and pelvic floor muscle training with biofeedback in women with multiple sclerosis for the management of overactive bladder.,"BACKGROUND Overactive bladder (OAB) is common in patients with multiple sclerosis (MS) with a limited number of treatment options. OBJECTIVE To investigate the effect of transcutaneous tibial nerve stimulation (TTNS) and pelvic floor muscle training (PFMT) with biofeedback on OAB symptoms in female MS patients. METHODS This study was conducted at the outpatient MS clinic in Istanbul. At baseline bladder diary, post-voiding residue (PVR), OAB, and Qualiveen Scales (QoL: Quality of Life; Siup: Specific Impact of Urinary Problems on QoL) were assessed. Patients were allocated to receive TTNS or PFMT daily for 6 weeks and reevaluated using the same tests. RESULTS Fifty-five patients (TTNS = 28, PFMT = 27) were included. Compared with baseline, both TTNS and PFMT groups improved in terms of OAB ( p  = 0.0001, p  = 0.0001), Qualiveen-siup ( p  = 0.0001, p  = 0.0001), Qualiveen-QoL ( p  = 0.002, p  = 0.006), PVR ( p  = 0.0001, p  = 0.21), frequency ( p  = 0.0001, p  = 0.69), nocturia ( p  = 0.0001, p  = 0.19), urgency ( p  = 0.0001, p  = 0.0001), and urge incontinence ( p  = 0.0001, p  = 0.0001). Between-group comparisons showed significant differences in 24-hour frequency ( p  = 0.002) in favor of TTNS. CONCLUSION Our study demonstrates the efficacy of both TTNS and PFMT for managing OAB symptoms in MS, associated with a significant impact on QoL, but did not show superiority of the methods. Further studies are needed to explore differences between these two non-invasive treatments.",2020,"Compared with baseline, both TTNS and PFMT groups improved in terms of OAB ( p  = 0.0001, p  = 0.0001), Qualiveen-siup ( p  = 0.0001, p  = 0.0001), Qualiveen-QoL ( p  = 0.002, p  = 0.006), PVR ( p  = 0.0001, p  = 0.21), frequency ( p  = 0.0001, p  = 0.69), nocturia ( p  = 0.0001, p  = 0.19), urgency ( p  = 0.0001, p  = 0.0001), and urge incontinence ( p  = 0.0001, p  = 0.0001).","['outpatient MS clinic in Istanbul', 'women with multiple sclerosis for the management of overactive bladder', 'Fifty-five patients (TTNS\u2009=\u200928, PFMT\u2009=\u200927) were included', 'patients with multiple sclerosis (MS', 'female MS patients']","['TTNS and PFMT', 'transcutaneous tibial nerve stimulation (TTNS) and pelvic floor muscle training (PFMT', 'TTNS or PFMT', 'transcutaneous tibial nerve stimulation and pelvic floor muscle training with biofeedback']","['OAB', 'baseline bladder diary, post-voiding residue (PVR), OAB, and Qualiveen Scales (QoL: Quality of Life; Siup: Specific Impact of Urinary Problems on QoL', 'nocturia', 'urge incontinence', '24-hour frequency', 'OAB symptoms', 'urgency', 'PVR', 'Qualiveen-QoL']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}]",55.0,0.139033,"Compared with baseline, both TTNS and PFMT groups improved in terms of OAB ( p  = 0.0001, p  = 0.0001), Qualiveen-siup ( p  = 0.0001, p  = 0.0001), Qualiveen-QoL ( p  = 0.002, p  = 0.006), PVR ( p  = 0.0001, p  = 0.21), frequency ( p  = 0.0001, p  = 0.69), nocturia ( p  = 0.0001, p  = 0.19), urgency ( p  = 0.0001, p  = 0.0001), and urge incontinence ( p  = 0.0001, p  = 0.0001).","[{'ForeName': 'Cansu', 'Initials': 'C', 'LastName': 'Polat Dunya', 'Affiliation': 'Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Tulek', 'Affiliation': 'Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kürtüncü', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Jalesh N', 'Initials': 'JN', 'LastName': 'Panicker', 'Affiliation': 'Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery and UCL Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'Mefkure', 'Initials': 'M', 'LastName': 'Eraksoy', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520926666'] 2166,32513069,"Naringin reduces body weight, plasma lipids and increases adiponectin levels in patients with dyslipidemia.","Naringin is a citrus-flavonoid which has been shown to have positive metabolic and anti-inflammatory effects. For this reason, we believe it would be interesting to study the effects of Naringin administration on body weight, BMI, lipid profile and adiponectin levels in patients with dyslipidemia, especially considering that dyslipidemias along with obesity and subsequent cardiometabolic complications are some of the most important public health issues plaguing our society today. A double-blind, randomized clinical trial was conducted in a group of 28 adult patients previously diagnosed with dyslipidemia who attended the Institute of Experimental and Clinical Therapeutics. Patients were divided into two groups; the first group (n = 14) received 450 mg of naringin every 24 hours, in the mornings, while the second group (n = 14) was given a homologated placebo over the course of a 90-day period. Significant differences were observed in naringin group compared to the placebo group in terms of decreased BMI (30.6 ± 3.19 vs 33.3 ± 3.23 kg/m 2 ; p = 0.03), total cholesterol (182 ± 20.2 vs 245 ± 24.1 mg/dl; p < 0.01), LDL cholesterol (100 ± 17.5 vs 125 ± 38.3 mg/dl; p = 0.03) and an increase in adiponectin levels (0.82 ± 0.25 vs 0.59 ± 0.19 μg/ml; p = 0.01). Our results support the use of Naringin as a potential therapeutic agent which could play an important role in the management of metabolic disorders.",2020,"Significant differences were observed in naringin group compared to the placebo group in terms of decreased BMI (30.6 ± 3.19 vs 33.3 ± 3.23 kg/m 2 ; p = 0.03), total cholesterol (182 ± 20.2 vs 245 ± 24.1 mg/dl; p < 0.01), LDL cholesterol (100 ± 17.5 vs 125 ± 38.3 mg/dl; p = 0.03) and an increase in adiponectin levels (0.82 ± 0.25 vs 0.59 ± ","['28 adult patients previously diagnosed with dyslipidemia who attended the Institute of Experimental and Clinical Therapeutics', 'patients with dyslipidemia']","['placebo', 'homologated placebo', '450\xa0mg of naringin', 'Naringin administration']","['total cholesterol', 'body weight, plasma lipids and increases adiponectin levels', 'LDL cholesterol', 'BMI', 'body weight, BMI, lipid profile and adiponectin levels', 'adiponectin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0068451', 'cui_str': 'naringin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",28.0,0.0529183,"Significant differences were observed in naringin group compared to the placebo group in terms of decreased BMI (30.6 ± 3.19 vs 33.3 ± 3.23 kg/m 2 ; p = 0.03), total cholesterol (182 ± 20.2 vs 245 ± 24.1 mg/dl; p < 0.01), LDL cholesterol (100 ± 17.5 vs 125 ± 38.3 mg/dl; p = 0.03) and an increase in adiponectin levels (0.82 ± 0.25 vs 0.59 ± ","[{'ForeName': 'Jessica Lucia', 'Initials': 'JL', 'LastName': 'Barajas-Vega', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}, {'ForeName': 'Abdel Kerim', 'Initials': 'AK', 'LastName': 'Raffoul-Orozco', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hernandez-Molina', 'Affiliation': 'Tonalá University Center, University of Guadalajara, Tonalá, México.'}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Ávila-González', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}, {'ForeName': 'Teresa Arcelia', 'Initials': 'TA', 'LastName': 'García-Cobian', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}, {'ForeName': 'Edy David', 'Initials': 'ED', 'LastName': 'Rubio-Arellano', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}, {'ForeName': 'Ernesto Javier', 'Initials': 'EJ', 'LastName': 'Ramirez-Lizardo', 'Affiliation': 'Institute of Experimental and Clinical Therapeutics, Department of Physiology, Health Sciences University Center, University of Guadalajara, Guadalajara, México.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000658'] 2167,32513111,Effect of caudal ketamine on minimum local anesthetic concentration of ropivacaine in children: a prospective randomized trial.,"BACKGROUND Caudal ketamine has been shown to provide an effective and prolonged post-operative analgesia with few adverse effects. However, the effect of caudal ketamine on the minimum local anesthetic concentration (MLAC) of ropivacaine for intra-operative analgesia is unclear. METHODS One hundred and sixty-nine children were randomized to five groups: Group C (caudal ropivacaine only), Group K 0.25 (caudal ropivacaine plus 0.25 mg/kg ketamine), Group K 0.5 (caudal ropivacaine plus 0.5 mg/kg ketamine), Group K 0.75 (caudal ropivacaine plus 0.75 mg/kg ketamine), and Group K 1.0 (caudal ropivacaine plus 1.0 mg/kg ketamine). The primary outcome was the MLAC values of ropivacaine with/without ketamine for caudal block. RESULTS The MLAC values of ropivacaine were 0.128% (0.028%) in the control group, 0.112% (0.021%) in Group K 0.25 , 0.112% (0.018%) in Group K 0.5 , 0.110% (0.019%) in Group K 0.75 , and 0.110% (0.020%) in Group K 1.0 . There were no significant differences among the five groups for the MLAC values (p = 0.11). During the post-operative period the mean durations of analgesia were 270, 381, 430, 494, and 591 min in the control, K 0.25 , K 0. 5 , K 0.75 , and K 1.0 groups respectively, which shown that control group is significantly different from all ketamine groups. Also there were significant differences between K 0.25 and K 0.75 groups, and between K 1.0 groups and the other ketamine groups. CONCLUSIONS Adding caudal ketamine to ropivacaine prolong the duration of post-operative analgesia; however, it does not decrease the MLAC of caudal ropivacaine for intra-operative analgesia in children. CLINICAL TRIAL REGISTRATION ChiCTR-TRC-13003492. Registered on 13 August 2013.",2020,There were no significant differences among the five groups for the MLAC values (p = 0.11).,"['One hundred and sixty-nine children', 'children']","['Group C (caudal ropivacaine only), Group K 0.25 (caudal ropivacaine plus 0.25\u2009mg/kg ketamine), Group K 0.5 (caudal ropivacaine plus 0.5\u2009mg/kg ketamine), Group K 0.75 (caudal ropivacaine plus 0.75\u2009mg/kg ketamine), and Group K 1.0 (caudal ropivacaine plus 1.0\u2009mg/kg ketamine', 'ropivacaine', 'caudal ketamine']","['MLAC values of ropivacaine with/without ketamine for caudal block', 'mean durations of analgesia', 'MLAC values of ropivacaine', 'duration of post-operative analgesia', 'minimum local anesthetic concentration', 'MLAC values']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441845', 'cui_str': 'Group K'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",169.0,0.0585345,There were no significant differences among the five groups for the MLAC values (p = 0.11).,"[{'ForeName': 'Huai-Zhen', 'Initials': 'HZ', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Ling-Yu', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Hui-Hong', 'Initials': 'HH', 'LastName': 'Liang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Fan', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Xing-Rong', 'Initials': 'XR', 'LastName': 'Song', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China.""}, {'ForeName': 'Ying-Jun', 'Initials': 'YJ', 'LastName': 'She', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, 9# Jinsui Road, Guangzhou, 510623, China. yjsheh@yeah.net.""}]",BMC anesthesiology,['10.1186/s12871-020-01058-y'] 2168,32513116,Supporting anticoagulant treatment decision making to optimise stroke prevention in complex patients with atrial fibrillation: a cluster randomised trial.,"BACKGROUND Anticoagulation for preventing stroke in atrial fibrillation is under-utilised despite evidence supporting its use, resulting in avoidable death and disability. We aimed to evaluate an intervention to improve the uptake of anticoagulation. METHODS We carried out a national, cluster randomised controlled trial in the Australian primary health care setting. General practitioners received an educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation or for whom anticoagulation was considered challenging. General practitioners were randomised to receive feedback from a medical specialist about the cases (expert decisional support) either before or after completing a post-test audit. The primary outcome was the proportion of patients reported as receiving oral anticoagulation. A secondary outcome assessed antithrombotic treatment as appropriate against guideline recommendations. RESULTS One hundred and seventy-nine general practitioners participated in the trial, contributing information about 590 cases. At post-test, 152 general practitioners (84.9%) completed data collection on 497 cases (84.2%). A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42). Sixty-one percent of patients in both groups received appropriate antithrombotic management according to evidence-based guidelines at post-test (Adjusted Relative Risk = 1.0; 95% CI = 0.85 to 1.19) (p = 0.97). CONCLUSIONS Specialist feed-back in addition to an educational session did not increase the uptake of anticoagulation in patients with AF. TRIAL REGISTRATION ANZCTRN12611000076976 Retrospectively registered.",2020,"A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42).","['Australian primary health care setting', 'General practitioners', 'complex patients with atrial fibrillation', 'One hundred and\xa0seventy-nine general practitioners participated in the trial, contributing information about 590 cases', 'patients with AF']","['educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation']","['proportion of patients reported as receiving oral anticoagulation', 'uptake of anticoagulation']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.336073,"A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42).","[{'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Gattellari', 'Affiliation': 'Department of Neurology, Institute for Clinical Neurosciences, Neuroscience Research, Royal Prince Alfred Hospital, Missenden Road, Sydney Local Health District, Camperdown (Sydney), New South Wales, 2050, Australia. melina.gattellari@health.nsw.gov.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 15 Broadway, Ultimo, New South Wales, 2007, Australia.'}, {'ForeName': 'Dominic Y C', 'Initials': 'DYC', 'LastName': 'Leung', 'Affiliation': 'South Western Sydney Clinical School UNSW, Liverpool, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health, Sciences and Medicine, Bond University, 14 University Drive, Robina, Queensland, 4226, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Institute for Clinical Neurosciences, Neuroscience Research, Royal Prince Alfred Hospital, Missenden Road, Sydney Local Health District, Camperdown (Sydney), New South Wales, 2050, Australia.'}]",BMC family practice,['10.1186/s12875-020-01175-0'] 2169,32513138,"Whole-brain irradiation with hippocampal sparing and dose escalation on metastases: neurocognitive testing and biological imaging (HIPPORAD) - a phase II prospective randomized multicenter trial (NOA-14, ARO 2015-3, DKTK-ROG).","BACKGROUND Whole brain radiation therapy (WBRT) is the standard therapy for multiple brain metastases. However, WBRT has a poor local tumor control and is associated with a decline in neurocognitive function (NCF). Aim of this trial is to assess the efficacy and safety of a new treatment method, the WBRT with hippocampus avoidance (HA) combined with the simultaneous integrated boost (SIB) on metastases/resection cavities (HA-WBRT+SIB). METHODS This is a prospective, randomized, two-arm phase II multicenter trial comparing the impact of HA on NCF after HA-WBRT+SIB versus WBRT+SIB in patients with multiple brain metastases. The study design is double-blinded. One hundred thirty two patients are to be randomized with a 1:1 allocation ratio. Patients between 18 and 80 years old are recruited, with at least 4 brain metastases of solid tumors and at least one, but not exceeding 10 metastases ≥5 mm. Patients must be in good physical condition and have no metastases/resection cavities in or within 7 mm of the hippocampus. Patients with dementia, meningeal disease, cerebral lymphomas, germ cell tumors, or small cell carcinomas are excluded. Previous irradiation and resection of metastases, as well as the number and size of metastases to be boosted have to comply with certain restrictions. Patients are randomized between the two treatment arms: HA-WBRT+SIB and WBRT+SIB. WBRT is to be performed with 30 Gy in 12 daily fractions and the SIB with 51 Gy/42 Gy in 12 daily fractions on 95% of volume for metastases/resection cavities. In the experimental arm, the dose to the hippocampi is restricted to 9 Gy in 98% of the volume and 17Gy in 2% of the volume. NCF testing is scheduled before WBRT, after 3 (primary endpoint), 9, 18 months and yearly thereafter. Clinical and imaging follow-ups are performed 6 and 12 weeks after WBRT, after 3, 9, 18 months and yearly thereafter. DISCUSSION This is a protocol of a randomized phase II trial designed to test a new strategy of WBRT for preventing cognitive decline and increasing tumor control in patients with multiple brain metastases. TRIAL REGISTRATION The HIPPORAD trial is registered with the German Clinical Trials Registry (DRKS00004598, registered 2 June 2016).",2020,"However, WBRT has a poor local tumor control and is associated with a decline in neurocognitive function (NCF).","['Patients between 18 and 80\u2009years old are recruited, with at least 4 brain metastases of solid tumors and at least one, but not exceeding 10 metastases ≥5\u2009mm', 'Patients with dementia, meningeal disease, cerebral lymphomas, germ cell tumors, or small cell carcinomas are excluded', 'patients with multiple brain metastases', 'One hundred thirty two patients']","['HA-WBRT+SIB and WBRT+SIB', 'Whole-brain irradiation with hippocampal sparing and dose escalation', 'HA-WBRT+SIB versus WBRT+SIB', 'Whole brain radiation therapy (WBRT', 'WBRT', 'WBRT with hippocampus avoidance (HA) combined with the simultaneous integrated boost (SIB']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0240803', 'cui_str': 'Primary cerebral lymphoma'}, {'cui': 'C0205851', 'cui_str': 'Germ cell tumor'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0535481,"However, WBRT has a poor local tumor control and is associated with a decline in neurocognitive function (NCF).","[{'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frings', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Bentsalo', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Oehlke', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Brenner', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Bilger', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Jamina Tara', 'Initials': 'JT', 'LastName': 'Fennell', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rothe', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schneider-Fuchs', 'Affiliation': 'Clinical Trials Unit, Faculty of Medicine, Medical Center - University of Freiburg, Elsässer Straße 2, 79110, Freiburg, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine, Medical Center - University of Freiburg, Stefan-Meier-Str. 26, 79104, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schmoor', 'Affiliation': 'Clinical Trials Unit, Faculty of Medicine, Medical Center - University of Freiburg, Elsässer Straße 2, 79110, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Medical Center - University of Freiburg, Breisacher Str. 64, 79106, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Department of Palliative Care, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': 'German Cancer Consortium (DKTK), Partner Site Freiburg, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Egger', 'Affiliation': 'Department of Neuroradiology, Faculty of Medicine, Medical Center - University of Freiburg, Breisacher Straße 64, 79106, Freiburg, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Urbach', 'Affiliation': 'Department of Neuroradiology, Faculty of Medicine, Medical Center - University of Freiburg, Breisacher Straße 64, 79106, Freiburg, Germany.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Lahmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, Hauptstraße 8, 79104, Freiburg, Germany.'}, {'ForeName': 'Ilinca', 'Initials': 'I', 'LastName': 'Popp', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center - University of Freiburg, Robert-Koch-Str. 3, 79106, Freiburg, Germany. ilinca.popp@uniklinik-freiburg.de.'}]",BMC cancer,['10.1186/s12885-020-07011-z'] 2170,32513143,Personalising screening of sight-threatening diabetic retinopathy - qualitative evidence to inform effective implementation.,"BACKGROUND Internationally, systematic screening for sight-threatening diabetic retinopathy (STDR) usually includes annual recall. Researchers and policy-makers support extending screening intervals, citing evidence from observational studies with low incidence rates. However, there is little research around the acceptability to people with diabetes (PWD) and health care professionals (HCP) about changing eye screening intervals. METHODS We conducted a qualitative study to explore issues surrounding acceptability and the barriers and enablers for changing from annual screening, using in-depth, semistructured interviews analysed using the constant comparative method. PWD were recruited from general practices and HCP from eye screening networks and related specialties in North West England using purposive sampling. Interviews were conducted prior to the commencement of and during a randomised controlled trial (RCT) comparing fixed annual with variable (6, 12 or 24 month) interval risk-based screening. RESULTS Thirty PWD and 21 HCP participants were interviewed prior to and 30 PWD during the parallel RCT. The data suggests that a move to variable screening intervals was generally acceptable in principle, though highlighted significant concerns and challenges to successful implementation. The current annual interval was recognised as unsustainable against a backdrop of increasing diabetes prevalence. There were important caveats attached to acceptability and a need for clear safeguards around: the safety and reliability of calculating screening intervals, capturing all PWD, referral into screening of PWD with diabetic changes regardless of planned interval. For PWD the 6-month interval was perceived positively as medical reassurance, and the 12-month seen as usual treatment. Concerns were expressed by many HCP and PWD that a 2-year interval was too lengthy and was risky for detecting STDR. There were also concerns about a negative effect upon PWD care and increasing non-attendance rates. Amongst PWD, there was considerable conflation and misunderstanding about different eye-related appointments within the health care system. CONCLUSIONS Implementing variable-interval screening into clinical practice is generally acceptable to PWD and HCP with important caveats, and misconceptions must be addressed. Clear safeguards against increasing non-attendance, loss of diabetes control and alternative referral pathways are required. For risk calculation systems to be safe, reliable monitoring and clear communication is required.",2020,Concerns were expressed by many HCP and PWD that a 2-year interval was too lengthy and was risky for detecting STDR.,"['Thirty PWD and 21 HCP participants', 'PWD were recruited from general practices and HCP from eye screening networks and related specialties in North West England using purposive sampling']",[],[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]",[],[],,0.0705146,Concerns were expressed by many HCP and PWD that a 2-year interval was too lengthy and was risky for detecting STDR.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Byrne', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK. paula.byrne@liverpool.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thetford', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gabbay', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Doncaster', 'Affiliation': 'ISDR Public Involvement Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': ""Eye and Vision Science, University of Liverpool and St. Paul's Eye Unit, Royal Liverpool University Hospital, Preston, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-08974-1'] 2171,32513153,The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.,"BACKGROUND Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health. METHODS/DESIGN This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care. Data are gathered at baseline (T0), at four months (T1) and eight months (T2) follow-up. Most outcomes will be assessed with validated patient-reported questionnaires. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as patients. DISCUSSION The trial is expected to result in a more effective physical therapy process for working patients with MSDs. This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism. TRIAL REGISTRATION Netherlands Trial Register, registration number: NL8518, date of registration 9 April 2020, URL registration: https://www.trialregister.nl/trial/8518.",2020,"This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism. ","['working patients with MSDs', '221 patients in each arm (442 in total', 'Working patients with MSDs visiting a physical therapy practice', 'patients with MSDs']","[""physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care"", 'normal physical therapy treatment', 'physical therapy']","['limitations in specific work-related activities and pain during work', 'limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3887623', 'cui_str': 'Job Performance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0831669,"This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism. ","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hutting', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands. Nathan.Hutting@han.nl.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Oswald', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands.'}, {'ForeName': 'Maria W G', 'Initials': 'MWG', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud Institute for Health Sciences, IQ healthcare, Radboud university medical centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Filart', 'Affiliation': 'School of Health, Physical Therapy, Saxion University of Applied Sciences, Enschede, The Netherlands.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Raaijmakers', 'Affiliation': 'Centre Work Health, Amersfoort, The Netherlands.'}, {'ForeName': 'Hendrik J', 'Initials': 'HJ', 'LastName': 'Bieleman', 'Affiliation': 'Saxion University of Applied Sciences, Research Group Health and Physical Activity, Enschede, The Netherlands.'}, {'ForeName': 'J Bart', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': 'Radboud Institute for Health Sciences, IQ healthcare, Radboud university medical centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne F', 'Initials': 'YF', 'LastName': 'Heerkens', 'Affiliation': 'School of Organisation and Development, Research Group Occupation & Health, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, The Netherlands.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03375-2'] 2172,32513161,"Acceptability of the ""MOVEdiabetes"" physical activity intervention in diabetes primary care settings in Oman: findings from participants and practitioners.","BACKGROUND Adequate physical activity (PA) is considered essential in diabetes management. However, evidence on the best method of promoting PA within diabetes care is inconclusive. The current work identifies perceptions on the acceptability of Intervention Group Participants (IGP) and Project Officers (POs) about the ""MOVEdiabetes"" intervention programme aimed at increasing PA in adults with type 2 diabetes in Oman (a retrospectively registered trial). METHODS The ""MOVEdiabetes"" programme (PA consultations, pedometers and WhatsApp messages) was delivered by the POs (primary health care practitioners) in four primary care centres within a one-year cluster randomised control trial. Recruitment and retention were measured from trial attendance records. Programme satisfaction, appropriateness, and content suitability were assessed using exit surveys for both the IGP (interview based) and POs (self-administered). Open text questions on perceptions to the study programme were also included. RESULTS Participants were randomised to an intervention group (IG, n = 122) or comparison group (CG, n = 110). The overall retention rate at three and 12 months was 92.7% [110(90.2%) IG vs 105(95.5%) CG] and 75% [82(67.2%) IG vs 92(83.6%) CG] respectively. Most (n = 14, 87.5%) POs and more than half (n = 49, 59.8%) IGP perceived the programme as very appropriate and many reported that they were ""quite/ very satisfied"" with the programme (n = 16, 100% PO's and n = 71, 86.6% IGP). Two thirds (n = 55, 66.0%) of IGP were very/quite likely to recommend the programme to others. PA consultations, use of pedometers and Whatsapp messages were well perceived by all. Participants recommended the inclusion of dietary advice and PA promotion for the general public. Exploring PA facilities within the community was suggested by POs. CONCLUSIONS The ""MOVEdiabetes"" programme achieved a high retention rate and was perceived as satisfactory and appropriate. Results from this study suggest that it is worthwhile exploring the use of the ""MOVEdiabetes"" programme in clinical practice and further community links. TRIAL REGISTRATION International Standard Randomised Controlled Trials No: ISRCTN14425284. Registered retrospectively on 12th April 2016.",2020,"IGP perceived the programme as very appropriate and many reported that they were ""quite/ very satisfied"" with the programme (n = 16, 100% PO's and n = 71, 86.6% IGP).","['diabetes primary care settings in Oman', 'adults with type 2 diabetes in Oman (a retrospectively registered trial']","['MOVEdiabetes"" physical activity intervention', 'MOVEdiabetes"" programme (PA consultations, pedometers and WhatsApp messages) was delivered by the POs (primary health care practitioners', 'IG vs 105(95.5%) CG', 'Intervention Group Participants (IGP) and Project Officers (POs) about the ""MOVEdiabetes"" intervention programme']","['Programme satisfaction, appropriateness, and content suitability', 'overall retention rate', 'retention rate']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.118228,"IGP perceived the programme as very appropriate and many reported that they were ""quite/ very satisfied"" with the programme (n = 16, 100% PO's and n = 71, 86.6% IGP).","[{'ForeName': 'Thamra S', 'Initials': 'TS', 'LastName': 'Alghafri', 'Affiliation': 'Directorate General of Health Services, Ministry of Health, Muscat, Oman & University of Dundee, PO Box 2723, Postal Code 112, Muscat, Oman. thamra74@yahoo.com.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Al Harthi', 'Affiliation': 'Directorate General of Health Services, Ministry of Health, Muscat, Oman.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Al-Ajmi', 'Affiliation': 'Directorate General of Health Services, Ministry of Health, Muscat, Oman.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Al-Farsi', 'Affiliation': 'Department of Family Medicine and Public Health, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Public Health Nutrition Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Bannerman', 'Affiliation': 'Global Academy of Agriculture & Food Security, The Royal (Dick) School of Veterinary Studies, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Public Health Nutrition Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.'}]",BMC public health,['10.1186/s12889-020-09029-1'] 2173,32513163,Findings from a pilot randomised trial of a social network self-management intervention in COPD.,"BACKGROUND Self-Management Support (SMS), refers to the actions taken by individuals to recognise and manage their own health. It is increasingly recognised that individuals with chronic obstructive pulmonary disease (COPD) require additional support with their Self-management. Emerging evidence suggests that the use of a social network intervention can improve health outcomes and increase quality of life. In order to understand the potential benefits of SMS in COPD, the GENIE (Generating Engagement in Network Support) SMS tool was implemented and evaluated in a COPD primary care context. The GENIE intervention is a social networking tool that consists of 3 parts; a concentric circle modelling to map existing social networks; a questions sections to elicit preferences for activities; a map of selected resources is then produced, aligned with the user's interests and suggestions for connections to existing network members and to new resources. METHODS A pilot, parallel, single blind, block randomised controlled trial. Patients with COPD ranging from mild-very severe were recruited. Participants provided written consent and were then randomised to either the intervention or usual care. The primary aim was to understand the clinical benefit through the analysis of health status, symptom burden and quality of life. The secondary outcome measure was health utilisation. NHS cost differences were reported between groups using the GENIE intervention over usual care. RESULTS The GENIE pilot results demonstrate maintenance in health status and clinical symptoms with a decrease in anxiety. An overall increase in quality of life was observed, these findings did not reach significance. A cost reduction was demonstrated in inpatient stay with no difference in primary care costs. Overall a cost reduction in NHS service utilisation was indicated in the intervention group. CONCLUSION This pilot study indicated that using a social network intervention can encourage the development of new social connections and extend existing support networks for COPD patients. Increasing network support in this population is of benefit to both patients and NHS providers in terms of cost reductions and enhancing wellbeing. This broadens the understanding of possible new approaches to SMS in community COPD patients, which could now be investigated in a larger population over a longer period. TRIAL REGISTRATION Clinical Trials.gov PRS National Library of Medicine. Protocol ID number: 19175, Clinical Trial ID: NCT02935452.",2020,"Overall a cost reduction in NHS service utilisation was indicated in the intervention group. ","['Patients with COPD ranging from mild-very severe were recruited', 'individuals with chronic obstructive pulmonary disease (COPD', 'community COPD patients', 'COPD patients']","['social network self-management intervention', 'social network intervention']","['quality of life', 'health status, symptom burden and quality of life', 'anxiety', 'health utilisation', 'health status and clinical symptoms', 'NHS service utilisation', 'health outcomes and increase quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0816965,"Overall a cost reduction in NHS service utilisation was indicated in the intervention group. ","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Welch', 'Affiliation': 'NIHR Wessex CLARHC, Southampton, UK. lw1c16@soton.ac.uk.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Orlando', 'Affiliation': 'NIHR Wessex CLARHC, Southampton, UK.'}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Lin', 'Affiliation': 'NIHR Wessex CLARHC, Southampton, UK.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Vassilev', 'Affiliation': 'NIHR Wessex CLARHC, Southampton, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'NIHR Wessex CLARHC, Southampton, UK.'}]",BMC pulmonary medicine,['10.1186/s12890-020-1130-1'] 2174,32513164,"The influence of mobile phone-based health reminders on patient adherence to medications and healthy lifestyle recommendations for effective management of diabetes type 2: a randomized control trial in Dhaka, Bangladesh.","BACKGROUND In 2017, 80% of 425 million adults with diabetes worldwide were living in low and middle-income countries. Diabetes affected 6.9 million adults in Bangladesh and accounted for 3% of the country's total mortality. Proper management of diabetes is the key to positive health outcomes. This study investigated how mobile phone-based health intervention could increase patient adherence and thereby improve the disease outcomes for diabetes type 2 in Bangladesh. METHODS A mobile phone-based health project (including mobile phone reminders and 24/7 call center) was implemented in Dhaka District, Bangladesh from January to December 2014. A randomized control trial was carried out, recruiting randomly in intervention and control groups among the patients receiving treatment for type 2 diabetes at the Bangladesh Institute of Health Sciences Hospital, Dhaka, Bangladesh. A total of 320 patients from both groups at baseline and 273 at endline were interviewed. RESULTS A significant improvement in patient adherence to diet, physical exercise, the cessation of use of tobacco and betel nut, and blood glycaemic control was found in the intervention group, whereas no such significant improvement was found in the control group. Cost and other co-morbidities were found to be the main reasons for non-adherence. CONCLUSION A mobile-health intervention should be considered as an additional option for non-communicable disease programs.",2020,"A significant improvement in patient adherence to diet, physical exercise, the cessation of use of tobacco and betel nut, and blood glycaemic control was found in the intervention group, whereas no such significant improvement was found in the control group.","['diabetes type 2 in Bangladesh', 'patients receiving treatment for type 2 diabetes at the Bangladesh Institute of Health Sciences Hospital, Dhaka, Bangladesh', 'A mobile phone-based health project (including mobile phone reminders and 24/7 call center) was implemented in Dhaka District, Bangladesh from January to December 2014', 'In 2017, 80% of 425 million adults with diabetes worldwide were living in low and middle-income countries', '320 patients from both groups at baseline and 273 at endline were interviewed', 'diabetes type 2']","['mobile phone-based health reminders', 'mobile phone-based health intervention']","['patient adherence to diet, physical exercise, the cessation of use of tobacco and betel nut, and blood glycaemic control']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0331487', 'cui_str': 'Areca catechu'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",0.0,0.0214823,"A significant improvement in patient adherence to diet, physical exercise, the cessation of use of tobacco and betel nut, and blood glycaemic control was found in the intervention group, whereas no such significant improvement was found in the control group.","[{'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Yasmin', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Germany. farzana.yasmin@uni-wh.de.'}, {'ForeName': 'Nazmun', 'Initials': 'N', 'LastName': 'Nahar', 'Affiliation': 'Independent Consultant, Marburg, Germany.'}, {'ForeName': 'Bilkis', 'Initials': 'B', 'LastName': 'Banu', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Liaquat', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Pothikrit Institute of Health Studies, Dhaka, Bangladesh.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sauerborn', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Aurélia', 'Initials': 'A', 'LastName': 'Souares', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Germany.'}]",BMC health services research,['10.1186/s12913-020-05387-z'] 2175,32513182,Caffeine supplementation is ergogenic in soccer players independent of cardiorespiratory or neuromuscular fitness levels.,"BACKGROUND Equivocal findings examining the influence of caffeine on performance and biological responses to exercise may be due to inter-individual variability in cardiorespiratory or neuromuscular fitness. This study examined whether the effects of caffeine ingestion on exercise performance and biological responses to prolonged intermittent exercise to exhaustion depend on cardiorespiratory or neuromuscular fitness. METHODS Twenty male soccer players, separated according to either cardiorespiratory fitness (high vs medium) or neuromuscular fitness (high vs medium) underwent two trials simulating the cardiovascular demands of a soccer game to exhaustion on treadmill after ingesting either caffeine (6 mg∙kg - 1 ) or placebo. Physical performance, cardiorespiratory and metabolic parameters and blood metabolites were evaluated. RESULTS Time to exhaustion (719 ± 288 vs 469 ± 228 s), jump height (42.7 ± 4.2 vs 38.6 ± 4.4 cm), heart rate (163 ± 12 vs 157 ± 13 b∙min - 1 ), mean arterial blood pressure (98 ± 8 vs 92 ± 10 mmHg), plasma glucose (5.6 ± 0.7 vs 5.3 ± 0.6 mmol∙l - 1 ) and lactate (3.3 ± 1.2 vs 2.9 ± 1.2 mmol∙l - 1 ) were higher, while rating of perceived exertion (12.6 ± 1.7 vs 13.3 ± 1.6) was lower with caffeine vs placebo (p < 0.01), independent of cardiorespiratory or neuromuscular fitness level. Reaction time; plasma glycerol, non-esterified fatty acids and epinephrine; carbohydrate and fat oxidation rates; and energy expenditure were not affected by caffeine (p > 0.05). CONCLUSIONS Caffeine was effective in improving endurance and neuromuscular performance in athletes with either high or medium cardiorespiratory and neuromuscular fitness. Cardiorespiratory and neuromuscular fitness do not appear to modulate the ergogenic effects of caffeine supplementation in well-trained athletes.",2020,Cardiorespiratory and neuromuscular fitness do not appear to modulate the ergogenic effects of caffeine supplementation in well-trained athletes.,"['athletes with either high or medium cardiorespiratory and neuromuscular fitness', 'soccer players', 'Twenty male soccer players, separated according to either cardiorespiratory fitness (high vs medium) or neuromuscular fitness (high vs medium) underwent two trials simulating the cardiovascular demands of a soccer game to exhaustion on treadmill after ingesting either']","['caffeine ingestion', 'caffeine supplementation', 'caffeine vs placebo', 'caffeine', 'Caffeine supplementation', 'Caffeine', 'placebo']","['Reaction time; plasma glycerol, non-esterified fatty acids and epinephrine; carbohydrate and fat oxidation rates; and energy expenditure', 'plasma glucose', 'heart rate', 'jump height', 'endurance and neuromuscular performance', 'mean arterial blood pressure', 'Physical performance, cardiorespiratory and metabolic parameters and blood metabolites']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",20.0,0.0447245,Cardiorespiratory and neuromuscular fitness do not appear to modulate the ergogenic effects of caffeine supplementation in well-trained athletes.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Apostolidis', 'Affiliation': 'Human Performance Laboratory, Department of Life & Health Sciences, University of Nicosia, 46 Makedonitissas Ave., P.O. Box 24005, 1700, Nicosia, Cyprus.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Mougios', 'Affiliation': 'Laboratory of Evaluation of Human Biological Performance, School of Physical Education & Sport Science, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Smilios', 'Affiliation': 'School of Physical Education & Sports Science, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Frangous', 'Affiliation': 'Nicosia General Hospital, Nicosia, Cyprus.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Hadjicharalambous', 'Affiliation': 'Human Performance Laboratory, Department of Life & Health Sciences, University of Nicosia, 46 Makedonitissas Ave., P.O. Box 24005, 1700, Nicosia, Cyprus. hadjicharalambous.m@unic.ac.cy.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00360-x'] 2176,32513192,"Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda.","BACKGROUND Despite initial high motivation, individuals receiving antiretroviral therapy (ART) for several years may experience incomplete adherence over time, increasing their risk of HIV-related morbidity and mortality. Habits, defined as automatic and regular practices, do not rely on conscious effort, and may therefore support high long-term ART adherence. METHODS This qualitative study contributes to the evidence on how clients with adherence problems remember and form habits to take ART medications. Free-listing and unstructured interviewing were used among 42 clinic-enrolled adults in Kampala, Uganda who were receiving ART and participating in a randomized clinical trial for treatment adherence (clinicaltrials.gov: NCT03494777). Data were coded and analyzed using inductive content analysis. RESULTS Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times. Efforts to improve ART habits included having a relative to ask about pill-taking, re-packaging medications, leaving medications in view, using alarms, carrying water, or linking pill-taking to radio/prayer schedules. Reported challenges were adhering to ART schedules during changing employment hours, social activities, and travel. CONCLUSION While habit-forming interventions have the potential to improve ART adherence, targeting treatment-mature clients' existing routines may be crucial in this population.",2020,"RESULTS Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times.","['clinic-enrolled HIV-infected adults', '42 clinic-enrolled adults in Kampala, Uganda who were receiving']","['ART', 'Free-listing and unstructured interviewing', 'antiretroviral therapy (ART']",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",[],,0.0592003,"RESULTS Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, Center for Sexual Health Promotion, 1025 E. 7th Street, Bloomington, IN, USA. ljmayowi@iu.edu.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Devoto', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Mildmay Hospital and Institute of Health Sciences, Box 24985, Kampala, Uganda.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Shelton', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of International Health, Social and Behavioral Interventions Program, 615\xa0N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Uzaib', 'Initials': 'U', 'LastName': 'Saya', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Mildmay Hospital and Institute of Health Sciences, Box 24985, Kampala, Uganda.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00283-2'] 2177,32513226,Evaluating dose delivered of a behavioral intervention for childhood obesity prevention: a secondary analysis.,"BACKGROUND Current recommendations for intensive behavioral interventions for childhood obesity treatment do not account for variable participant attendance, optimal duration of the intervention, mode of delivery (phone vs. face-to-face), or address obesity prevention among young children. A secondary analysis of an active one-year behavioral intervention for childhood obesity prevention was conducted to test how ""dose delivered"" was associated with body mass index z-score (BMI-Z) across 3 years of follow-up. METHODS Parent-child pairs were eligible if they qualified for government assistance and spoke English or Spanish. Children were between three and 5 years old and were at risk for but not yet obese (BMI percentiles ≥50th and < 95th). The intended intervention dose was 18 h over 3-months via 12 face-to-face ""intensive sessions"" (90 min each) and 6.75 h over the next 9 months via 9 ""maintenance phone calls"" (45 min each). Ordinary least-squares multivariable regression was utilized to test for associations between dose delivered and child BMI-Z immediately after the 1-year intervention, and at 2-, and 3-year follow-up, including participants who were initially randomized to the control group as having ""zero"" dose. RESULTS Among 610 parent-child pairs (intervention n = 304, control n = 306), mean child age was 4.3 (SD = 0.9) years and 51.8% were female. Mean dose delivered was 10.9 (SD = 2.5) of 12 intensive sessions and 7.7 (SD = 2.4) of 9 maintenance calls. Multivariable linear regression models indicated statistically significant associations of intensive face-to-face contacts (B = -0.011; 95% CI [- 0.021, - 0.001]; p = 0.029) and maintenance calls (B = -0.015; 95% CI [- 0.026, - 0.004]; p = 0.006) with lower BMI-Z immediately following the 1-year intervention. Their interaction was also significant (p = 0.04), such that parent-child pairs who received higher numbers of both face-to-face intensive sessions (> 6) and maintenance calls (> 8) were predicted to have lower BMI-Z. Sustained impacts were not statistically significant at 2- or 3-year follow-up. CONCLUSIONS In a behavioral intervention for childhood obesity prevention, the combination of a modest dose of face-to-face sessions (> 6 h over 3 months) with sustained maintenance calls (> 8 calls over 9 months) was associated with improved BMI-Z at 1-year for underserved preschool aged children, but sustained impacts were not statistically significant at 2 or 3 year follow-up. CLINICAL TRIAL REGISTRATION The trial was registered on ClinicalTrials.gov (NCT01316653) on March 16, 2011, which was prior to participant enrollment.",2020,"Multivariable linear regression models indicated statistically significant associations of intensive face-to-face contacts (B = -0.011; 95% CI [- 0.021, - 0.001]; p = 0.029) and maintenance calls (B = -0.015; 95% CI [- 0.026, - 0.004]; p = 0.006) with lower BMI-Z immediately following the 1-year intervention.","['childhood obesity prevention', '610 parent-child pairs (intervention n\u2009=\u2009304, control n\u2009=\u2009306), mean child age was 4.3 (SD\u2009=\u20090.9) years and 51.8% were female', 'young children', 'Parent-child pairs were eligible if they qualified for government assistance and spoke English or Spanish']","['control group as having ""zero"" dose', 'behavioral intervention']",['BMI-Z'],"[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.0378767,"Multivariable linear regression models indicated statistically significant associations of intensive face-to-face contacts (B = -0.011; 95% CI [- 0.021, - 0.001]; p = 0.029) and maintenance calls (B = -0.015; 95% CI [- 0.026, - 0.004]; p = 0.006) with lower BMI-Z immediately following the 1-year intervention.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA. bill.heerman@vumc.org.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Qi', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, 2525 West End Ave., Nashville, TN, 37203-1741, USA.'}, {'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, 230 Appleton Place, Nashville, TN, 37203-5721, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave., Nashville, TN, 37212-3504, USA.'}]",BMC public health,['10.1186/s12889-020-09020-w'] 2178,32513229,"Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.","BACKGROUND The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal including a vitrectomy followed by peeling of the ERM using a microforceps. As the internal limiting membrane (ILM) is adherent to the ERM, it is sometimes removed with it (spontaneous peeling). If ILM remains in place, it can be removed to reduce ERM recurrence. However, it is important to clarify the safety of ILM peeling, while it increases surgical risks and cause histological disorganization of the retina that can lead to microscotomas, may be responsible for definitive visual discomfort. METHODS PEELING is a prospective, randomized, controlled, single-blind, and multicentered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling. Randomization is done in the operating room after ERM removal if ILM remains in place. After randomization, the two groups-""active peeling of the ILM"" and ""no peeling of the ILM""-are compared during a total of three follow-up visits scheduled at month 1, month 6, and month 12. Primary endpoint is the difference in microscotomas before surgery and 6 months after surgery. Patients with spontaneous peeling are not randomized and are included in the ancillary study with the same follow-up visits and the same examinations as the principal study. Relevant inclusion criteria involve individuals aged > 18 years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts. The calculated sample size corresponds to 53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling). DISCUSSION ILM peeling is often practiced in ERM surgery to reduce ERM recurrence. It does not impair postoperative visual acuity, but it increases the surgical risks and causes anatomical damages. If active ILM peeling is significantly associated with more microscotomas, it may contraindicate the ILM peeling during primitive idiopathic ERM surgery. TRIAL REGISTRATION ClinicalTrials.gov, NCT02146144. Registered on 22 May 2014. Recruitment is still ongoing.",2020,This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling.,"['Patients with spontaneous peeling', 'individuals undergoing ERM surgery without spontaneous ILM peeling', 'Relevant inclusion criteria involve individuals aged >\u200918\u2009years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts', '53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling']",[],"['surgical risks', 'ERM recurrence', 'postoperative visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",106.0,0.255661,This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling.,"[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Ducloyer', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Ivan', 'Affiliation': 'Clinical Investigation Centre CIC1413, INSERM and CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, INSERM and CHU Nantes, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lebreton', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bonissent', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fossum', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Ophthalmology Department, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Creuzot-Garchet', 'Affiliation': 'Ophthalmology Department, CHU Dijon, Dijon, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Le Mer', 'Affiliation': 'Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Perol', 'Affiliation': ""Ophthalmology Department, Polyclinique de l'Atlantique, Saint-Herblain, France.""}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Fortin', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Billaud', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ivan', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Department of Ophthalmology, CHU Nantes, Nantes, France.'}]",Trials,['10.1186/s13063-020-04433-9'] 2179,32513231,Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES To determine the efficacy of Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide in reducing the need for invasive mechanical ventilatory support for patients with COVID-19. Hydroxychloroquine is currently being used in multiple trials with varying doses in an attempt to treat COVID-19. Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS. Dual therapy by combining appropriate doses of these two medications with diverse activities against COVID-19 is expected to be better than monotherapy with hydroxychloroquine. TRIAL DESIGN This is a single centre, randomized, controlled, single blinded, 2 arm (ratio 1:1) parallel group trial. PARTICIPANTS 86 COVID-19 positive patients that are being treated at the Health Institute of the State of Mexico (ISEM) in Toluca, State of Mexico will be recruited from May 14 to December 31, 2020. INCLUSION CRITERIA 1)Age older than 18 years.2)Hospitalised COVID-19 PCR test positive patients.3)Within the first 72 hours after performing the PCR test.4)Presence of risk factors for complications (at least one): over 60 years, history of diabetes mellitus, hypertension, and morbid obesity. EXCLUSION CRITERIA 1)Patients with corrected QT interval (QTc) greater than 500ms at hospital admission.2)Patients who have inherent contraindications to each drug.3)Patients who are unable to consent.4)Patients who have previously received chloroquine.5)Patients already intubated. Elimination criteria: 1)Patients whose clinical follow-up is lost or who decide not to continue in the study INTERVENTION AND COMPARATOR: The two management alternatives will be: Control - Hydroxychloroquine 200 mg taken orally every 12 hours for 7 days. Dual therapy - Hydroxychloroquine 400 mg taken orally every 12 hours for two days and then 200 mg taken orally every 12 hours for four days + Nitazoxanide 500 mg orally every 6 hours taken with food, for seven days. MAIN OUTCOMES Primary: Mechanical ventilation requirement assessed at one week. Percentage of COVID-19 positive patients who require mechanical ventilation . All patients will be monitored till hospital discharge or death. RANDOMISATION Patients will be randomly allocated using allocation papers and opaque sealed envelopes to either receive the placebo or the dual therapy intervention treatment in a 1:1 ratio until we have recruited the required number of patients for each group. BLINDING (MASKING) Trial participants will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 86 participants will be randomized to each group, with 43 in the control group and 43 in the dual therapy group. TRIAL STATUS Protocol version: 2, recruitment will begin on May 14 until sample size is reached , with the analysis deadline of December 31st 2020. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04341493. Date of trial registration: April 10, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS.,"['patients with COVID-19', 'COVID-19 patients with risk factors for poor prognosis', '1)Patients with corrected QT interval (QTc) greater than 500ms at hospital admission.2)Patients who have inherent contraindications to each drug.3)Patients who are unable to consent.4)Patients who have previously received chloroquine.5)Patients already intubated', '86 COVID-19 positive patients that are being treated at the Health Institute of the State of Mexico (ISEM) in Toluca, State of Mexico will be recruited from May 14 to December 31, 2020', '86 participants will be randomized to each group, with 43 in the control group and 43 in the dual therapy group']","['Nitazoxanide', 'Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide', 'hydroxychloroquine', 'Hydroxychloroquine', 'Control - Hydroxychloroquine', 'Dual therapy - Hydroxychloroquine', 'placebo or the dual therapy intervention treatment', 'Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide']",['hospital discharge or death'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",86.0,0.38205,Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS.,"[{'ForeName': 'José Meneses', 'Initials': 'JM', 'LastName': 'Calderón', 'Affiliation': 'Internal Medicine, Intensive Care Unit, ""Lic. Adolfo López Mateos"" General Hospital, Toluca, Mexico.'}, {'ForeName': 'Hugo Mendieta', 'Initials': 'HM', 'LastName': 'Zerón', 'Affiliation': 'Autonomous University of the State of Mexico (UAEMex), Internal Medicine and Medical Sciences (UNAM), Endocrinology, University of Santiago de Compostela, Santiago de Compostela, Spain. hmendietaz@uaemex.mx.'}, {'ForeName': 'Srivatsan', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Internal Medicine, St. Joseph Medical Center, Tacoma, WA, USA.'}]",Trials,['10.1186/s13063-020-04448-2'] 2180,32513245,Study protocol for prognosis and treatment strategy of peripheral persistent avascular retina after intravitreal anti-VEGF therapy in retinopathy of prematurity.,"BACKGROUND Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents. However, there are doubts regarding the necessity of this prophylactic action regardless of fundus fluorescein angiography (FFA) results. The adverse prognosis for persistent avascular retina after anti-VEGF therapy in ROP patients is not well understood. The relationship between vascular leakage and an adverse prognosis is also unknown. Therefore, it would be of value to study the above issues to shape the treatment strategy of persistent avascular retina after intravitreal anti-VEGF therapy in ROP patients. METHODS/DESIGN This is a prospective study of ROP patients with persistent avascular retina who have received anti-VEGF intravitreal therapy and have never received laser therapy. All the eyes being studied will be followed up and examined by FFA after anti-VEGF treatment and categorized into two groups, a leakage group and a non-leakage group according to the extent of vascular leakage from FFA results. The eyes being studied in the leakage group will be further randomized into two groups, a laser group and a non-laser group. A cohort study (observational) will be conducted on the non-leakage group and the non-laser group (with leakage) to investigate the incidence of an adverse prognosis for reactivation, retinal tear and retinal detachment; as well as to investigate the relationship between vascular leakage from FFA results and the abovementioned pathological changes. A randomized controlled study (experimental) will be conducted on the leakage group to compare the prognosis between the laser group and the non-laser group. DISCUSSION The present study aims to investigate the occurrence rates of an adverse prognosis including reactivation, retinal tear and retinal detachment after anti-VEGF therapy in ROP patients with persistent avascular retina; to assess the relationship between vascular leakage from FFA results and the abovementioned pathological changes; to compare the prognosis of persistent avascular retina with or without prophylactic peripheral photocoagulation in these patients; to shape the treatment strategy and provide evidence for the indications of prophylactic photocoagulation. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR-ROC-17013253. Registered on 5 November 2017. http://www.chictr.org.cn/showproj.aspx?proj=22703.",2020,"BACKGROUND Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents.","['ROP patients with persistent avascular retina who have received', 'ROP patients with persistent avascular retina', 'retinopathy of prematurity']","['prophylactic peripheral photocoagulation', 'laser therapy', 'laser group and a non-laser group', 'intravitreal anti-VEGF therapy', 'VEGF therapy', 'Prophylactic peripheral photocoagulation', 'anti-VEGF intravitreal therapy']",[],"[{'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0311809,"BACKGROUND Prophylactic peripheral photocoagulation has been proposed to be applied to persistent, peripheral, avascular retina for retinopathy of prematurity (ROP) patients who have received an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Jianxun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Wensi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China.""}, {'ForeName': 'Daoman', 'Initials': 'D', 'LastName': 'Xiang', 'Affiliation': ""Department of Ophthalmology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510230, China. xiangdm35@126.com.""}]",Trials,['10.1186/s13063-020-04371-6'] 2181,32513251,"Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"['HER2-positive, locally advanced or metastatic breast cancer']","['Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane']",[],"[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C2608038', 'cui_str': 'Eribulin mesylate'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]",[],,0.0233853,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, 241-8515, Japan. tyamashita@kcch.jp.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka, 540-0006, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Department of Medical Oncology, Fukeushima Medical University, 1 Hikarigaoka Fukushima, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Araki', 'Affiliation': 'Department of Breast Surgery, Gunma Prefectural Cancer Center, 617-1 Takahayashinishicho, Ota, Gunma, 373-8550, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology, Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Breast Surgery, NHO Hokkaido Cancer Center, 2-3-54 Yonjyo Kikusui Shiraishi-ku, Sapporo-shi, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Department of Medical Oncology, Showa University Hospital, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, 142-8666, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kitada', 'Affiliation': 'Breast Disease Center, Asahikawa Medical University Hospital, 1-1 Higashi 2-jyo 1-chome, Midorigaoka, Asahikawa-shi, Hokkaido, 078-8510, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Department of Breast Surgery, St. Marianna University School of Medicine Hospital, 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Breast Surgical Oncology, Sagara Hospital, 3-31 Matsubaracho Kagoshima-shi, Kagoshima, 892-0833, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Breast and Endocrine Surgical Oncology, Tohoku University Hospital, 1-1 Seiryocho Aoba-ku, Sendai-shi, Miyagi, 980-8574, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Iwasa', 'Affiliation': 'Oncology Internal Medicine, Kindai University Hospital, 377-2 Ohnohigashi Sayama-shi Osaka, Osaka, 589-8511, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kadoya', 'Affiliation': 'Breast Surgery, Hiroshima University Hospital, 1-2-3 Kasumi Minami-ku Hiroshima-shi, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Tsuguo', 'Initials': 'T', 'LastName': 'Iwatani', 'Affiliation': 'Department of Breast Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Eisai Co., Ltd., 4-6-10 Koishikawa Bunkyo-ku, Tokyo, 112-8088, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Breast Oncology Center, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake Koto-ku, Tokyo, 135-8550, Japan.'}]",Trials,['10.1186/s13063-020-04408-w'] 2182,32513252,Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial.,"BACKGROUND Intraarticular distal humeral fractures of AO/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results vary and are sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semi-constrained TEA. No studies have compared the results of EHA to that of ORIF, but case series have reported promising results. METHODS/DESIGN This is a study protocol describing an investigator-initiated, non-blinded randomized controlled trial comparing the outcome of EHA with ORIF for AO/OTA type 13 C2 and C3 fractures of the distal humerus in patients who are 50 years or older. Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus will be randomized to either EHA or ORIF. The Oxford Elbow Score (OES) will be used as primary outcome. Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes. Reoperations, complications, and the length of sick leave will be recorded. The patients will be examined after the operation and at 3 months and 1, 2, 5, and 10 years. DISCUSSION The main objective of this study is to investigate the best treatment option for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above. We hypothesize that EHA results in fewer complications and superior functional outcome compared with ORIF and that the mechanical complications related to the linked articulation of TEA can be avoided. TRIAL REGISTRATION ClinicalTrials.gov, PRS, NCT04163172. Registered November 13, 2019. https://clinicaltrials.gov/ct2/results?cond=&term=evori&cntry=&state=&city=&dist= (Table 2). The protocol has been approved by The Scientific Ethics Committee of the Capital Region of Denmark (Jr. no.: H - 19,035,590 ). The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). Inclusion started on February 1, 2020.",2020,"Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes.","['patients aged 50\u2009years or above', 'Forty-four patients with AO/OTA type 13 C2 and C3 fractures of distal humerus', 'patients who are 50\u2009years or older']","['internal fixation (ORIF', 'Elbow hemiarthroplasty versus open reduction and internal fixation', 'EHA or ORIF', 'EHA with ORIF', 'Total elbow arthroplasty (TEA', 'Elbow hemiarthroplasty (EHA']","['Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction', 'Reoperations, complications, and the length of sick leave', 'Oxford Elbow Score (OES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0186781', 'cui_str': 'Total elbow replacement'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C2960719', 'cui_str': 'Oxford elbow score'}]",44.0,0.0605465,"Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Hamdani', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. akhamdani@hotmail.com.'}, {'ForeName': 'Jeppe V', 'Initials': 'JV', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Holtz', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo S', 'Initials': 'BS', 'LastName': 'Olsen', 'Affiliation': 'Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04418-8'] 2183,32513257,"Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study.","BACKGROUND Diabetic foot ulcers (DFUs) are the most common cause of leg amputations and their management is extremely challenging. Despite many advances and expensive therapies, there has been little success in improving outcomes of DFUs. In prior work our laboratory has examined the effects of beta-adrenergic antagonists (βAAs) on skin and skin-derived cells. We have shown that βAAs enhance the rate of keratinocyte migration, promote angiogenesis, and hasten wound healing in scratch wounds in vitro, in animal wound models, and in anecdotally reported cases of chronic wounds that healed successfully after topical application of the βAA timolol. Thus, we propose to test timolol directly on DFUs to determine if it improves healing above the current standard of care (SOC). This study will examine the efficacy and safety of topically applied beta-antagonist Timoptic-XE® (timolol maleate ophthalmic gel forming solution) in subjects with DFUs. METHODS/DESIGN This is a phase two, randomized, double-blinded, controlled, and parallel-group clinical trial with two treatment arms, SOC plus topical Timoptic-XE® and SOC plus a non-biologically active gel (hydrogel, as placebo drug). Study subjects with a DFU will be selected from the Veterans Affairs Northern California Health Care System (VANCHCS). Study duration is up to 31 weeks, with three phases (screening phase for two weeks, active phase for up to 12 weeks, with an additional second consecutive confirmatory visit after 2 weeks, and follow-up phase comprising monthly visits for 4 months). Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first. Measurements of wound size and other data will be collected at baseline, followed by weekly visits for 12 weeks, and then a monthly follow-up period. DISCUSSION This is a clinical translation study, moving the investigators' pre-clinical laboratory research into a translational study in which we will analyze clinical outcomes to assess for safety and estimate the efficacy of a topical beta-antagonist in healing of DFUs. The results from this trial may establish new treatment paradigms and safety profile for DFU treatment. TRIAL REGISTRATION ClinicalTrials.gov, NCT03282981. Registered on June 14th, 2018.",2020,"Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first.","['subjects with DFUs', 'chronic diabetic foot ulcers', 'Diabetic foot ulcers (DFUs', 'Study subjects with a DFU will be selected from the Veterans Affairs Northern California Health Care System (VANCHCS']","['Beta-adrenergic antagonist', 'beta-antagonist Timoptic-XE® (timolol maleate ophthalmic gel forming solution', 'βAA timolol', 'SOC plus topical Timoptic-XE® and SOC plus a non-biologically active gel (hydrogel, as placebo', 'timolol', 'topical beta-antagonist', 'placebo']","['efficacy and safety', 'healing above the current standard of care (SOC']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0040235', 'cui_str': 'Timoptic'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0991531', 'cui_str': 'Eye gel'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205460', 'cui_str': 'Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",,0.264798,"Subjects will apply daily either the topical study drug or the placebo on the foot ulcer for 12 weeks or until healed, whichever comes first.","[{'ForeName': 'Ramanjot', 'Initials': 'R', 'LastName': 'Kaur', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tchanque-Fossuo', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'West', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Hadian', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gallegos', 'Affiliation': 'Department of Dermatology, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Yoon', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Ligia', 'Initials': 'L', 'LastName': 'Ismailyan', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Schaefer', 'Affiliation': 'Department of Internal Medicine, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Dahle', 'Affiliation': 'Department of Dermatology, UC Davis Medical Center, Sacramento, CA, USA. sara.dahle@va.gov.'}, {'ForeName': 'R Rivkah', 'Initials': 'RR', 'LastName': 'Isseroff', 'Affiliation': 'Dermatology Service, VA Northern California Health Care System, Mather, CA, USA. rrisseroff@ucdavis.edu.'}]",Trials,['10.1186/s13063-020-04413-z'] 2184,32513260,Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial.,"BACKGROUND A wound that does not heal in the orderly stages of the healing process or does not heal within 3 months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and protease inhibitors in the wound bed; bacterial colonization and the presence of biofilm; and oxidative stress. Recently, wound management has improved significantly. A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine. This dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation. The primary aim of this study is to compare the effect of the antioxidant dressing on chronic wound healing against the use of a standard wound dressing in patients with hard-to-heal wounds. METHODS We will conduct a multicentre, single-blind, randomized controlled trial with parallel groups. Participants will be selected from three primary public health care centres located in Andalucía (southern Spain). Patients will be randomized into an intervention group (antioxidant dressing) or a control group (standard wound dressing). Assessments will be carried out at weeks 2, 4, 6 and 8. Follow-up will be for a period of 8 weeks or until complete healing if this occurs earlier. DISCUSSION The findings from this study should provide scientific evidence on the efficacy of the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills some of the gaps in the existing knowledge about patients with hard-to-heal wounds. TRIAL REGISTRATION ClinicalTrials.gov: NCT03934671. Registered on 2 May 2019.",2020,"A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine.","['Participants will be selected from three primary public health care centres located in Andalucía (southern Spain', 'patients with hard-to-heal wounds']","['antioxidant dressing', 'standard wound dressing', 'Antioxidant dressing therapy', 'intervention group (antioxidant dressing) or a control group (standard wound dressing']",['Wound healing'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.119934,"A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from locust bean gum galactomannan and a hydration solution with curcumin and N-acetylcysteine.","[{'ForeName': 'Inés María', 'Initials': 'IM', 'LastName': 'Comino-Sanz', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain. icomino@ujaen.es.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'López-Franco', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Castro', 'Affiliation': 'Histocell S.L., Bizkaia Science and Technology Park, Derio, Bizkaia, Spain.'}, {'ForeName': 'Pedro Luis', 'Initials': 'PL', 'LastName': 'Pancorbo-Hidalgo', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, Las Lagunillas S/N, 23071, Jaén, Spain.'}]",Trials,['10.1186/s13063-020-04445-5'] 2185,32513273,The effect of transtheoretical model-lead intervention for knee osteoarthritis in older adults: a cluster randomized trial.,"BACKGROUND Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms, and knee function in older adults with KOA. METHODS A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018. The present study lasted 48 weeks, with an intervention duration of 0-24 weeks and follow-up time of 24-48 weeks. The intervention was a two-stage and 24-week TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise adherence interventions. The primary outcome was exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0 = not at all through and 10 = completely as instructed) self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee function (lower limb muscle strength and balance) was measured using the Five-Times-Sit-to-Stand Test (FTSST) and the Timed Up and Go Test (TUG) at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA, and independent t test were the main statistical tests used. RESULTS A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, the TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function. CONCLUSION Over time, TTM-HEI could improve participants' exercise adherence, KOA symptoms, and knee function. TRIAL REGISTRATION This study was approved by the ethics committee (IRB00001052-17066) in July 2017 and was registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn, registry number: ChiCTR1800015458).",2020,"The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48.","['Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018', 'knee osteoarthritis in older adults', 'older adults with KOA', '189 older adults (intervention group: n\u2009=\u2009103, control group: n\u2009=\u200986) were enrolled', 'people over 60\u2009years old']","['transtheoretical model-lead home exercise intervention (TTM-HEI) program', 'TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise adherence interventions', 'Exercise therapy', 'transtheoretical model-lead intervention']","['growth rate of exercise adherence', 'exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0\u2009=\u2009not at all through and 10\u2009=\u2009completely as instructed) self-rating scale', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee function (lower limb muscle strength and balance', ""participants' exercise adherence, KOA symptoms, and knee function"", 'relieving KOA symptoms and improving knee function', 'exercise adherence, KOA symptoms, and knee function', 'exercise adherence', 'KOA symptoms (pain intensity and joint stiffness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040953', 'cui_str': 'Trichotillomania'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}]",189.0,0.106611,"The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48.","[{'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Yunlin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Jieru', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Recovery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'Qiaoqin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China.'}, {'ForeName': 'Shaomei', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'School of Nursing, Peking University, 38 Xueyuan Road, Hai Dian District, Beijing, China. shangshaomei@126.com.'}]",Arthritis research & therapy,['10.1186/s13075-020-02222-y'] 2186,32513277,"Effect of household water treatment with chlorine on diarrhea among children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia: a cluster randomized controlled trial.","BACKGROUND Diarrheal disease is a leading cause of child mortality and morbidity worldwide. Household water treatment with chlorine significantly reduces morbidity due to waterborne diseases. However, the effect of point-of-use (POU) water treatment in improving the quality of water in areas where POU is not provided free of charge and the effectiveness of home visits in inspiring household members to use POU regularly have not been studied. The objective of this study was to evaluate the effectiveness of drinking water disinfection by chlorination on diarrheal disease reduction among children under the age of 5 years in rural eastern Ethiopia. METHODS A cluster randomized controlled trial was carried out in rural Dire Dawa from October 2018 through January 2019. The 405 households were randomized to intervention and control arms and intervention materials were distributed after conducting a baseline survey. This trial evaluated the effectiveness of household drinking water disinfection by chlorination in reducing incidence of diarrhea among children under the age of 5 years. Intervention households received 1.2% sodium hypochlorite with demonstration of its proper use. Participants in the control households continued with their usual habits of water collection and water storage. Generalized estimation equation (GEE) with log link Poisson distribution family and exchangeable correlation matrix was used to compute crude incidence rate ratio (IRR), adjusted IRR and the corresponding 95% confidence intervals. RESULTS In the intervention households, in total, 281 cases of diarrhea were documented (8.7 cases per 100 person-weeks observation); in the control households, in total 446 cases of diarrhea were documented (13.8 cases per 100 person-weeks observation). A 36.0% (adjusted IRR = 0.64, 95% CI: 0.57-0.73) reduction in incidence of diarrhea was observed in the intervention arm when compared with the control arm. The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively. Adherence to the intervention was 81.3% as measured by free residual chlorine test. CONCLUSIONS In rural areas where diarrhea is the second leading cause of morbidity, water chlorination at the household level using liquid bleach considerably reduced episodes of diarrhea among children under the age of 5 years. Therefore, chlorinating drinking water at the household level may be a valuable interim solution for reducing the incidence of diarrheal diseases until potable water is made accessible to the majority of the population in Dire Dawa Administration and other Ethiopian communities. TRIAL REGISTRATION PACTR, PACTR201807815961394. Registered 16 July 2018, www.pactr.org.",2020,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","['Participants in the control households continued with their usual habits of water collection and water storage', 'children under the age of 5 years', '405 households', 'children under the age of 5 years in rural eastern Ethiopia', 'rural Dire Dawa from October 2018 through January 2019', 'children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia']","['drinking water disinfection by chlorination', 'household drinking water disinfection', 'household water treatment with chlorine']","['diarrhea', 'diarrheal disease reduction', 'incidence rate ratio (IRR), adjusted IRR', 'incidence of diarrhea', 'morbidity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0175961', 'cui_str': 'Chlorination'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",405.0,0.0647436,"The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively.","[{'ForeName': 'Ephrem Tefera', 'Initials': 'ET', 'LastName': 'Solomon', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia. ephtesol@gmail.com.'}, {'ForeName': 'Sirak', 'Initials': 'S', 'LastName': 'Robele', 'Affiliation': 'Ethiopian Institute of Water Resources, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Kloos', 'Affiliation': 'Haramaya University, College of Health and Medical Sciences, Harar, Ethiopia.'}, {'ForeName': 'Bezatu', 'Initials': 'B', 'LastName': 'Mengistie', 'Affiliation': 'University of California, San Francisco Medical Center, San Francisco, CA, USA.'}]",Infectious diseases of poverty,['10.1186/s40249-020-00680-9'] 2187,32513288,"Clinical application of the AUC-guided dosage adjustment of docetaxel-based chemotherapy for patients with solid tumours: a single centre, prospective and randomised control study.","BACKGROUND Docetaxel (DTX) is a widely used anti-tumour drug, and its dosage is solely determined by body surface area (BSA). Adverse events, such as neutropenia or unsatisfied efficacy, likely occur because of differences in the pharmacokinetics (PK) and pharmacodynamics of patients. Thus, a feasible dosage adjustment method is needed. METHODS A total of 209 eligible patients who provided consent were enrolled and randomised into two groups to receive the BSA- and PK-guided dosage adjustments of DTX-based chemotherapy (3 weeks per cycle). The AUC of DTX was detected, and the therapeutic window for Chinese patients was determined. The proportion of patients within the therapeutic window was evaluated. Neutropenia was examined in accordance with the toxicity grading standard suggested by the World Health Organisation. Tumour response was assessed in accordance with Response Evaluation Criteria in Solid Tumors version 1.1. The primary endpoint was the incidence of neutropenia, and the secondary endpoints were disease control rate (DCR) and 3-year survival rate. RESULTS The therapeutic window for Chinese patients was 1.7-2.5 mg·h/L. The proportion of patients within the therapeutic window was 63.89% versus 28.33% (P < 0.0001), and the incidence of neutropenia was 68.33% versus 38.89% (P = 0.001) in the experimental group versus the control group in the sixth cycle, respectively. DCR was 72% versus 85% (P = 0.018) in the control group versus the experimental group. The 3-year survival rate of the PK group was significantly higher than that of the BSA group (P = 0.034). CONCLUSIONS The PK-guided dosage adjustment of DTX could significantly increase the proportion of patients within the therapeutic window, decrease the incidence of neutropenia and increase the DCR and the 3-year survival rate. The PK-guided dosage adjustment based on the dynamic monitoring of AUC could be a useful method for oncologists to improve individualised treatment options, optimise drug efficacy and reduce drug toxicity.",2020,DCR was 72% versus 85% (P = 0.018) in the control group versus the experimental group.,"['209 eligible patients who provided consent', 'Chinese patients was 1.7-2.5\xa0mg·h/L', 'patients with solid tumours']","['BSA', 'docetaxel-based chemotherapy', 'BSA- and PK-guided dosage adjustments of DTX-based chemotherapy', 'Docetaxel (DTX']","['DCR and the 3-year survival rate', 'incidence of neutropenia', 'Tumour response', '3-year survival rate', 'Adverse events, such as neutropenia or unsatisfied efficacy', 'Neutropenia', 'pharmacokinetics (PK) and pharmacodynamics', 'disease control rate (DCR) and 3-year survival rate', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]","[{'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",209.0,0.0288337,DCR was 72% versus 85% (P = 0.018) in the control group versus the experimental group.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Huayun', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Geyu', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering, Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Deliang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, No. 42, Baiziting, Nanjing, 210009, China. zhangyanonco@outlook.com.'}]",Journal of translational medicine,['10.1186/s12967-020-02394-w'] 2188,32508378,Effects on performance of active and passive hypoxia as a re-warm-up routine before a 100-metre swimming time trial: a randomized crossover study.,"Passive and active hypoxia could be used as a tool during a transitional phase to maintain the effects of warm-up and optimize athletic performance. Our purpose was to evaluate and compare the effects of four different re-warm-up strategies, i.e. rest in normoxia (RN) at FiO 2 = 20.9%, rest in hypoxia (RH) at FiO 2 = 15%, active (5 minutes dryland-based exercise circuit) in normoxia (AN) and active in hypoxia (AH), during the transitional phase, on subsequent 100 m maximal swimming performance. Thirteen competitive swimmers (n = 7 males; n = 6 females; age: 15.1±2.1 years; height: 164.7±8.8 cm; weight: 58.1±9.7 kg; 100 m season's best time 72.0±11.8 s) completed a 20-minute standardized in-water warm-up followed by a 30-minute randomized transitional phase and 100 m freestyle time trial. Compared to AH (73.4±6.2 s), 100 m swim time trials were significantly ( p = 0.002; η 2 = 0.766) slower in RN (75.7±6.7 s; p = 0.01), AN (75.2±6.7 s; p = 0.038) and RH (75.0±6.4 s; p = 0.009). Moreover, compared to AH (36.3±0.4ºC), tympanic temperature was significantly lower ( p <0.001; η 2 = 0.828) at the end of the transitional phase in passive conditions (RN: 35.9±0.6; p = 0.032; RH: 36.0±0.4; p = 0.05). In addition, countermovement jump height at the end of the transitional phase was significantly higher in active than in passive conditions (p = 0.001; η2 = 0.728). A dryland-based circuit under hypoxia could be useful to swimmers, once it has attenuated the decline in tympanic temperature during a 30-minute transitional phase after warm-up, improving 100 m swimming performance in young amateur swimmers.",2020,"Moreover, compared to AH (36.3±0.4ºC), tympanic temperature was significantly lower ( p <0.001; η 2 = 0.828) at the end of the transitional phase in passive conditions (RN: 35.9±0.6; p = 0.032; RH: 36.0±0.4; p = 0.05).","[""Thirteen competitive swimmers (n = 7 males; n = 6 females; age: 15.1±2.1 years; height: 164.7±8.8 cm; weight: 58.1±9.7 kg; 100 m season's best time 72.0±11.8 s) completed a 20-minute standardized in-water warm-up followed by a 30-minute randomized transitional phase and 100 m freestyle time trial"", 'young amateur swimmers']",[],"['countermovement jump height', 'performance of active and passive hypoxia', 'tympanic temperature']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}]",,0.0359727,"Moreover, compared to AH (36.3±0.4ºC), tympanic temperature was significantly lower ( p <0.001; η 2 = 0.828) at the end of the transitional phase in passive conditions (RN: 35.9±0.6; p = 0.032; RH: 36.0±0.4; p = 0.05).","[{'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, UCAM, Catholic University San Antonio, Murcia, Spain.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Batalha', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciência e Tecnologia, Universidade de Évora, Évora, Portugal.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Parraca', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciência e Tecnologia, Universidade de Évora, Évora, Portugal.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Sousa', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciência e Tecnologia, Universidade de Évora, Évora, Portugal.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tomas-Carus', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciência e Tecnologia, Universidade de Évora, Évora, Portugal.'}]",Biology of sport,['10.5114/biolsport.2020.93035'] 2189,32508379,"Effects of strength training under hypoxic conditions on muscle performance, body composition and haematological variables.","The addition of a hypoxic stimulus during resistance training is suggested to increase the metabolic responses, enhancing hypertrophy and muscle strength. The purpose of this study was to investigate the effects of resistance training performed at submaximal intensities combined with normobaric hypoxia on muscular performance, body composition and haematological parameters. Thirty-two untrained subjects participated in this study (weight: 74.68±12.89 kg; height: 175±0.08 cm; BMI: 24.28±3.80 kg/m 2 ). They were randomized to two groups: hypoxia (FiO 2 = 13%) or normoxia (FiO 2 = 20.9%). The training programme lasted 7 weeks (3 d/w) and several muscle groups were exercised (3 sets x 65-80% 1RM to failure). Measurements were taken before, after the training and after a 3-week detraining period. Body composition and muscle mass were assessed through skinfolds and muscle girths. Muscle strength was evaluated by the 1RM estimated test. Finally, haemoglobin and haematocrit were taken from the antecubital vein. Both groups improved their strength performance and muscle perimeters, but the hypoxia group obtained a greater increase in muscle mass (hypoxia: +1.80% vs. normoxia: +0.38%; p <0.05) and decrease in fat mass (hypoxia: -6.83% vs. normoxia: +1.26%; p <0.05) compared to the normoxia group. Additionally, haematocrit values were also higher for the hypoxia group after the detraining period (hypoxia: +2.20% vs. normoxia: -2.22%; p <0.05). In conclusion, resistance training under hypoxic conditions could increase muscle mass and decrease fat mass more effectively than training performed in normoxia, but without contributing to greater muscle strength.",2020,"Both groups improved their strength performance and muscle perimeters, but the hypoxia group obtained a greater increase in muscle mass (hypoxia: +1.80% vs. normoxia: +0.38%; p <0.05) and decrease in fat mass (hypoxia: -6.83% vs. normoxia: +1.26%; p <0.05) compared to the normoxia group.",['Thirty-two untrained subjects participated in this study (weight: 74.68±12.89 kg; height: 175±0.08 cm; BMI: 24.28±3.80 kg/m 2 '],"['strength training', 'resistance training performed at submaximal intensities combined with normobaric hypoxia']","['metabolic responses, enhancing hypertrophy and muscle strength', 'haemoglobin and haematocrit', 'Muscle strength', 'muscle performance, body composition and haematological variables', 'strength performance and muscle perimeters', 'muscle mass', 'haematocrit values', 'Body composition and muscle mass', 'fat mass', 'muscular performance, body composition and haematological parameters']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",32.0,0.0149122,"Both groups improved their strength performance and muscle perimeters, but the hypoxia group obtained a greater increase in muscle mass (hypoxia: +1.80% vs. normoxia: +0.38%; p <0.05) and decrease in fat mass (hypoxia: -6.83% vs. normoxia: +1.26%; p <0.05) compared to the normoxia group.","[{'ForeName': 'Ismael Martínez', 'Initials': 'IM', 'LastName': 'Guardado', 'Affiliation': 'GAEDAF Research Group. Faculty of Sport Science, University of Extremadura, Spain.'}, {'ForeName': 'Braulio Sánchez', 'Initials': 'BS', 'LastName': 'Ureña', 'Affiliation': 'School of Human Movement Sciences and Quality of Life, National University of Costa Rica, Costa Rica.'}, {'ForeName': 'Alba Camacho', 'Initials': 'AC', 'LastName': 'Cardenosa', 'Affiliation': 'GAEDAF Research Group. Faculty of Sport Science, University of Extremadura, Spain.'}, {'ForeName': 'Marta Camacho', 'Initials': 'MC', 'LastName': 'Cardenosa', 'Affiliation': 'GAEDAF Research Group. Faculty of Sport Science, University of Extremadura, Spain.'}, {'ForeName': 'Guillermo Olcina', 'Initials': 'GO', 'LastName': 'Camacho', 'Affiliation': 'GAEDAF Research Group. Faculty of Sport Science, University of Extremadura, Spain.'}, {'ForeName': 'Rafael Timón', 'Initials': 'RT', 'LastName': 'Andrada', 'Affiliation': 'GAEDAF Research Group. Faculty of Sport Science, University of Extremadura, Spain.'}]",Biology of sport,['10.5114/biolsport.2020.93037'] 2190,32508384,"Running-based high-intensity interval training vs. small-sided game training programs: effects on the physical performance, psychophysiological responses and technical skills in young soccer players.","This study aimed to compare the effects of 5-week running-based high-intensity interval training (HIIT) vs. small-sided game training (SSG) on the physical performance, psychophysiological responses and technical skills in young soccer players. Twenty young male soccer players (age: 14.2±0.5 years, height: 161.8±7.9 cm) participated in this study and were assigned to two groups: the HIIT group (n=10) and SSG group (n=10). Both groups trained twice per week with a similar total training duration. The SSG consisted of two 5-9 minutes of 2-a-side with 2-minute passive rest periods, whereas the HIIT consisted of 12-20 minutes of continuous runs at intensities (90 to 95%) related to the velocity obtained in the 30-15 intermittent fitness test. Before and after the 5-week training periods the following tests were completed: maximum oxygen consumption (VO 2max ) from the Yo-Yo Intermittent Recovery Test level 1 (YYIRTL-1), 10-30-m sprint test, countermovement jump [CMJ], squat jump [SJ], and drop jump [DJ]), 1000-m run test, zigzag agility, repeated sprint ability, 30-15 intermittent fitness test and speed dribbling ability test. Our results revealed meaningful improvements in YYIRTL-1 performance (SSG: +12.8%, standardized effect size [ d ]=-1.46; HIIT: +16.4%, d =3.27 and VO 2max (SSG: +3.3%, d =-1.48; HIIT: +4.3%, d =2.61). There was a meaningful greater improvement in agility and technical test performances following the SSG training compared with the HIIT (p ≤ 0.05, d =ranging from 0.92 to 1.99). By contrast, the HIIT group showed meaningfully higher performance responses in terms of the 1000-m running time and repeated sprint test ability (p ≤ 0.05, d =ranging from 0.90 to 2.06). These results confirmed that SSG training might be a more effective training regime to improve technical ability and agility with greater enjoyment, whereas HIIT might be more suitable for speed-based conditioning in young soccer players.",2020,"There was a meaningful greater improvement in agility and technical test performances following the SSG training compared with the HIIT (p ≤ 0.05, d =ranging from 0.92 to 1.99).","['young soccer players', 'Twenty young male soccer players (age: 14.2±0.5 years, height: 161.8±7.9 cm) participated in this study']","['5-week running-based high-intensity interval training (HIIT) vs. small-sided game training (SSG', 'SSG training', 'SSG', 'Running-based high-intensity interval training vs. small-sided game training programs']","['YYIRTL-1 performance', '1000-m running time and repeated sprint test ability', 'performance responses', 'agility and technical test performances', 'maximum oxygen consumption (VO 2max ) from the Yo-Yo Intermittent Recovery Test level 1 (YYIRTL-1), 10-30-m sprint test, countermovement jump [CMJ], squat jump [SJ], and drop jump [DJ]), 1000-m run test, zigzag agility, repeated sprint ability, 30-15 intermittent fitness test and speed dribbling ability test', 'physical performance, psychophysiological responses and technical skills']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0013132', 'cui_str': 'Dribbling from mouth'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",20.0,0.0183499,"There was a meaningful greater improvement in agility and technical test performances following the SSG training compared with the HIIT (p ≤ 0.05, d =ranging from 0.92 to 1.99).","[{'ForeName': 'Ersan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Siirt University, School of Physical Education and Sports, Siirt, Turkey.'}, {'ForeName': 'Gamze Erikoglu', 'Initials': 'GE', 'LastName': 'Orer', 'Affiliation': 'Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Sport Sciences, Ankara, Turkey.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal.""}]",Biology of sport,['10.5114/biolsport.2020.94237'] 2191,32508570,Transcranial Static Magnetic Field Stimulation of the Motor Cortex in Children.,"Background Non-invasive neuromodulation is an emerging therapy for children with early brain injury but is difficult to apply to preschoolers when windows of developmental plasticity are optimal. Transcranial static magnetic field stimulation (tSMS) decreases primary motor cortex (M1) excitability in adults but effects on the developing brain are unstudied. Objective/Hypothesis We aimed to determine the effects of tSMS on cortical excitability and motor learning in healthy children. We hypothesized that tSMS over right M1 would reduce cortical excitability and inhibit contralateral motor learning. Methods This randomized, sham-controlled, double-blinded, three-arm, cross-over trial enrolled 24 healthy children aged 10-18 years. Transcranial Magnetic Stimulation (TMS) assessed cortical excitability via motor-evoked potential (MEP) amplitude and paired pulse measures. Motor learning was assessed via the Purdue Pegboard Test (PPT). A tSMS magnet (677 Newtons) or sham was held over left or right M1 for 30 min while participants trained the non-dominant hand. A linear mixed effect model was used to examine intervention effects. Results All 72 tSMS sessions were well tolerated without serious adverse effects. Neither cortical excitability as measured by MEPs nor paired-pulse intracortical neurophysiology was altered by tSMS. Possible behavioral effects included contralateral tSMS inhibiting early motor learning ( p < 0.01) and ipsilateral tSMS facilitating later stages of motor learning ( p < 0.01) in the trained non-dominant hand. Conclusion tSMS is feasible in pediatric populations. Unlike adults, tSMS did not produce measurable changes in MEP amplitude. Possible effects of M1 tSMS on motor learning require further study. Our findings support further exploration of tSMS neuromodulation in young children with cerebral palsy.",2020,Neither cortical excitability as measured by MEPs nor paired-pulse intracortical neurophysiology was altered by tSMS.,"['children with early brain injury', 'young children with cerebral palsy', 'healthy children', '24 healthy children aged 10-18 years', 'Children']","['Transcranial Static Magnetic Field Stimulation', 'tSMS', 'Transcranial static magnetic field stimulation (tSMS', '\n\n\nNon-invasive neuromodulation', 'Transcranial Magnetic Stimulation (TMS', 'M1 tSMS']","['tolerated without serious adverse effects', 'MEPs nor paired-pulse intracortical neurophysiology', 'ipsilateral tSMS facilitating later stages of motor learning', 'Motor learning', 'cortical excitability', 'cortical excitability and motor learning', 'contralateral tSMS inhibiting early motor learning', 'cortical excitability via motor-evoked potential (MEP) amplitude and paired pulse measures', 'MEP amplitude']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.336761,Neither cortical excitability as measured by MEPs nor paired-pulse intracortical neurophysiology was altered by tSMS.,"[{'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Hollis', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Zewdie', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Hilderley', 'Affiliation': 'Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Hsing-Ching', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Carlson', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kirton', 'Affiliation': 'Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00464'] 2192,32508602,"Corrigendum: The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis.",[This corrects the article DOI: 10.3389/fnint.2018.00041.].,2020,[This corrects the article DOI: 10.3389/fnint.2018.00041.].,[],['Therapeutic Touch and Deep Touch Pressure'],"['Range of Motion, Interoceptive Accuracy and Heart Rate Variability']",[],"[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0665528,[This corrects the article DOI: 10.3389/fnint.2018.00041.].,"[{'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Johnston', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}]",Frontiers in integrative neuroscience,['10.3389/fnint.2020.00028'] 2193,32508677,Short-Term Effect of Different Taping Methods on Local Skin Temperature in Healthy Adults.,"Background There were limited studies on the effect of skin temperature and local blood flow using kinesio tape (KT) adhered to the skin in different taping methods. This study aimed to determine the short-term effect of KT and athletic tape (AT) on skin temperature in the lower back and explore the possible effect of different taping methods (Y-strip and fan-strip taping) on local microcirculation. Materials and Methods Twenty-six healthy participants completed the test-retest reliability measurement of the infrared thermography (IRT), intraclass correlation coefficient (ICC), and standard error of measurement (SEM) were calculated to evaluate the reliability. Then, 21 healthy participants received different taping condition randomly for 5 times, including Y-strip of kinesio taping (KY), fan-strip of kinesio taping (Kfan), Y-strip of athletic taping (AY), fan-strip of athletic taping (Afan), and no taping (NT). Above taping methods were applied to the participants' erector spinae muscles on the same side. Skin temperature of range of interest (ROI) was measured in the taping area through IRT at pre taping and 10 min after taping. Additionally, participants completed self-perceived temperature evaluation for different taping methods through visual analog scaling. One-way repeated-measured analysis of variance was used to compare the temperature difference among different taping methods. Bonferroni test was used for post hoc analysis. Results There was a good test-retest reliability (ICC = 0.82, 95% CI = 0.60-0.92; SEM = 0.33; and MD = 0.91) of the IRT. Significant differences were observed in the short-term effect on skin temperature among all different taping methods ( p = 0.012, F = 3.435, and η p 2 = 0.147), post hoc test showed a higher significantly skin temperature difference in Kfan taping compared to no taping ( p = 0.026, 95% CI = 0.051-1.206); However, no significant differences were observed among self-perceived temperature ( p = 0.055, F = 2.428, and η p 2 = 0.108). Conclusion This study showed that the fan-strip of KT increased significantly the skin temperature of the waist after taping for 10 min. The application of KT may modify the skin temperature of the human body and promote local microcirculation, although it remained unclear for the real application.",2020,"Significant differences were observed in the short-term effect on skin temperature among all different taping methods ( p = 0.012, F = 3.435, and η p 2 = 0.147), post hoc test showed a higher significantly skin temperature difference in Kfan taping compared to no taping ( p = 0.026, 95% CI = 0.051-1.206);","['21 healthy participants', 'Healthy Adults']","['Different Taping Methods', 'KT and athletic tape (AT', 'kinesio tape (KT', 'taping methods (Y-strip and fan-strip taping', 'taping condition randomly for 5 times, including Y-strip of kinesio taping (KY), fan-strip of kinesio taping (Kfan), Y-strip of athletic taping (AY), fan-strip of athletic taping (Afan), and no taping (NT']","['Local Skin Temperature', 'skin temperature difference', 'skin temperature', 'good test-retest reliability', 'skin temperature and local blood flow', 'Skin temperature of range of interest (ROI', 'self-perceived temperature', 'test-retest reliability measurement of the infrared thermography (IRT), intraclass correlation coefficient (ICC), and standard error of measurement (SEM']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C2350263', 'cui_str': 'Orthotic Tape'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",21.0,0.0743608,"Significant differences were observed in the short-term effect on skin temperature among all different taping methods ( p = 0.012, F = 3.435, and η p 2 = 0.147), post hoc test showed a higher significantly skin temperature difference in Kfan taping compared to no taping ( p = 0.026, 95% CI = 0.051-1.206);","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Zhouying', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Department of Rehabilitation, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, Shanghai Fifth Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Zixing', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Shengqun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Qu', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.'}]",Frontiers in physiology,['10.3389/fphys.2020.00488'] 2194,32508897,The Effects of Cerebral Vasospasm on Cerebral Blood Flow and the Effects of Induced Hypertension: A Mathematical Modelling Study.,"Background Induced hypertension has been used to promote cerebral blood flow under vasospastic conditions although there is no randomised clinical trial to support its use. We sought to mathematically model the effects of vasospasm on the cerebral blood flow and the effects of induced hypertension. Methods The Anatomically Detailed Arterial Network (ADAN) model is employed as the anatomical substrate in which the cerebral blood flow is simulated as part of the simulation of the whole body arterial circulation. The pressure drop across the spastic vessel is modelled by inserting a specific constriction model within the corresponding vessel in the ADAN model. We altered the degree of vasospasm, the length of the vasospastic segment, the location of the vasospasm, the pressure (baseline mean arterial pressure [MAP] 90 mm Hg, hypertension MAP 120 mm Hg, hypotension), and the presence of collateral supply. Results Larger decreases in cerebral flow were seen for diffuse spasm and more severe vasospasm. The presence of collateral supply could maintain cerebral blood flow, but only if the vasospasm did not occur distal to the collateral. Induced hypertension caused an increase in blood flow in all scenarios, but did not normalise blood flow even in the presence of moderate vasospasm (30%). Hypertension in the presence of a complete circle of Willis had a marginally greater effect on the blood flow, but did not normalise flow. Conclusion Under vasospastic condition, cerebral blood flow varies considerably. Hypertension can raise the blood flow, but it is unable to restore cerebral blood flow to baseline.",2020,"Induced hypertension caused an increase in blood flow in all scenarios, but did not normalise blood flow even in the presence of moderate vasospasm (30%).","['Induced Hypertension', 'Conclusion\n\n\nUnder vasospastic condition']",['Cerebral Vasospasm'],"['Cerebral Blood Flow', 'cerebral blood flow', 'blood flow', 'cerebral flow', 'severe vasospasm']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}]",,0.0189244,"Induced hypertension caused an increase in blood flow in all scenarios, but did not normalise blood flow even in the presence of moderate vasospasm (30%).","[{'ForeName': 'Pervinder', 'Initials': 'P', 'LastName': 'Bhogal', 'Affiliation': 'Department of Interventional Neuroradiology, The Royal London Hospital, London, United Kingdom.'}, {'ForeName': 'Leonard Leong', 'Initials': 'LL', 'LastName': 'Yeo', 'Affiliation': 'Division of Neurology, Department of Medicine, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Lucas O', 'Initials': 'LO', 'LastName': 'Müller', 'Affiliation': 'National Laboratory for Scientific Computing, LNCC/MCTIC, Petrópolis, Brazil.'}, {'ForeName': 'Pablo J', 'Initials': 'PJ', 'LastName': 'Blanco', 'Affiliation': 'National Laboratory for Scientific Computing, LNCC/MCTIC, Petrópolis, Brazil.'}]",Interventional neurology,['10.1159/000496616'] 2195,32508953,"Efficacy and Safety of Bushenjiangya-Optimized Granule for Left Ventricular Diastolic Dysfunction in Hypertensive Patients: A Double-Blind, Randomized, Placebo-Controlled Trial.","Objective The study aimed to evaluate the efficacy and safety of Bushenjiangya-optimized (BSJYO) granule on left ventricular diastolic dysfunction (LVDD) in hypertensive (HTN) patients. Methods 120 patients diagnosed with HTN plus LVDD were randomly assigned to the BSJYO granule group and placebo group, and all patients received basal western medicine (WM) treatment. After eight weeks of treatment, we evaluated echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events. Major adverse cardiovascular events (MACEs) were collected at 6-month follow-up. Results Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P < 0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P < 0.01). There were no differences between treatment groups in kidney and liver function, early adverse events, or MACE. Conclusion BSJYO granule plus basal WM is an effective and safe therapy for HTN patients with LVDD.",2020,"Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P < 0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P < 0.01).","['hypertensive (HTN) patients', 'Hypertensive Patients', '120 patients diagnosed with HTN plus LVDD', 'HTN patients with LVDD']","['Placebo', 'Bushenjiangya-Optimized Granule', 'Bushenjiangya-optimized (BSJYO) granule', 'basal western medicine (WM) treatment', 'placebo']","['Efficacy and Safety', 'effective response (SER), effective response (ER), and total effective response (TER\u2009=\u2009SER\u2009+\u2009ER) in TCM symptom scores', 'left ventricular diastolic dysfunction (LVDD', 'kidney and liver function, early adverse events, or MACE', 'Left Ventricular Diastolic Dysfunction', 'E/Ea (Doppler-derived index of filling pressure and worsening LVDD', 'echocardiography, traditional Chinese medicine (TCM) syndromes, 24-hour ambulatory blood pressure, liver and kidney functions, and adverse events', 'Major adverse cardiovascular events (MACEs']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273070', 'cui_str': 'Left ventricular diastolic dysfunction'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",120.0,0.0678889,"Compared with pretreatment, E/Ea (Doppler-derived index of filling pressure and worsening LVDD) significantly decreased significantly after 8 weeks of treatment in the BSJYO granule plus basal WM group (10.52 ± 1.87 vs. 9.49 ± 1.49, P < 0.01), alongside reductions in significantly effective response (SER), effective response (ER), and total effective response (TER = SER + ER) in TCM symptom scores (21.59% vs. 71.70%, P < 0.01).","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100070, China.'}, {'ForeName': 'Xiao-Yun', 'Initials': 'XY', 'LastName': 'Cui', 'Affiliation': 'Department of Cardiology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Wen-Ying', 'Initials': 'WY', 'LastName': 'Fan', 'Affiliation': 'Department of Acupuncture, Qinghai Hospital of Traditional Chinese Medicine, Xining 810000, China.'}, {'ForeName': 'Pin-Hui', 'Initials': 'PH', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou 570203, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Jin-Jin', 'Initials': 'JJ', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Hainan Provincial Hospital of Traditional Chinese Medicine, Haikou 570203, China.'}, {'ForeName': 'Wen-Bai', 'Initials': 'WB', 'LastName': 'Qu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing 100029, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Scientific Research Division, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100070, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7190352'] 2196,32508970,Prospective randomized study evaluating the usefulness of a surgical smoke evacuation system in operating rooms for breast surgery.,"Background No prospective evaluation of surgical smoke evacuation systems has yet been conducted anywhere in the world. A prospective randomized study was conducted to clarify the usefulness of a surgical smoke evacuation system in terms of reducing the quantity of environmental pollutants found in operating room air and reducing the occupational exposure of doctors and nurses involved in surgical procedures to surgical smoke, volatile organic compounds, formaldehyde, etc. Methods Operating room environment conditions with and without the use of a surgical smoke evacuation system were measured, and the personal exposure levels of doctors and nurses involved in surgical procedures were also surveyed. Use of the evacuation system was determined randomly, and the procedures involved were breast-conserving surgery and mastectomy, which were treated as stratification factors. Results The average total volatile organic compound concentration in the operating room was significantly lower when the evacuation system was used compared with when it was not used. The findings were similar for formaldehyde concentration. Multiple regression analysis for healthcare professionals' personal exposure levels showed that the evacuation system was a factor that significantly impacted their formaldehyde and acetaldehyde personal exposure levels, which were greatly reduced by the use of the system. Conclusion This study's findings demonstrate the effectiveness of the evacuation systems, which should increase awareness that their benefits take priority over the drawbacks. Trial registration The study was conducted after explaining to participants that it was a study of operating room environments in which their participation was voluntary and obtaining their consent. The study was also approved by the Tokai University Hospital clinical research review committee (no. 5R-022) and registered with the UMIN registry (UMIN000029092) on 13, September, 2017- retrospectively registered.",2020,"Multiple regression analysis for healthcare professionals' personal exposure levels showed that the evacuation system was a factor that significantly impacted their formaldehyde and acetaldehyde personal exposure levels, which were greatly reduced by the use of the system. ",['operating rooms for breast surgery'],"['surgical smoke evacuation system', 'surgical smoke evacuation systems']",['average total volatile organic compound concentration'],"[{'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0192272,"Multiple regression analysis for healthcare professionals' personal exposure levels showed that the evacuation system was a factor that significantly impacted their formaldehyde and acetaldehyde personal exposure levels, which were greatly reduced by the use of the system. ","[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Tokuda', 'Affiliation': 'Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Takuho', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Maruta', 'Affiliation': 'Tokai University Hospital Department of Nursing, Isehara, Japan.'}, {'ForeName': 'Mutsuko', 'Initials': 'M', 'LastName': 'Orita', 'Affiliation': 'Tokai University Hospital Department of Nursing, Isehara, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Department of Materials and Life Sciences, Seikei University, Musashino, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Matsuki', 'Affiliation': 'Department of Nursing, Tokai University School of Medicine, Isehara, Japan.'}]","Journal of occupational medicine and toxicology (London, England)",['10.1186/s12995-020-00259-y'] 2197,32508977,Development and Application of One Separation-Free Safety Tube on the Disposable Infusion Needle.,"Objective To develop a new type infusion set and apply it to the clinic, as well as explore its effectiveness in the prevention from needle stick injuries. Methods A total of 200 inpatients who were in need of intravenous infusion with a disposable infusion needle were included and randomly divided into two groups: intervention group and control group. Disposable infusion needles with a separation-free safety tube were used in the intervention group, whereas conventional ones were used in the control group. Then, effects of the two types of infusion sets were observed and compared. Results As for the operation time for infusion, it was (82.19 ± 1.80) seconds in the intervention group and (83.02 ± 1.83) seconds in the control group, with the difference statistically significant ( P < 0.05). Besides, the exposure time of the needles after infusion in the intervention group was (3.36 ± 0.17) seconds while (18.85 ± 1.18) seconds in the control group; the difference between which was statistically significant ( P < 0.05). In terms of the time for needle disposal, (18.60 ± 0.84) seconds was required in the intervention group, while for the control group, it took (18.85 ± 1.18) seconds, and the difference between two groups was of statistical significance as well ( P < 0.05). Nevertheless, there was no statistically significant difference in the accidental slip rate of the needles as that turned out 0% in both groups ( P > 0.05). It was worth noting that the block rate of the disposed needles in the intervention group was 100%. Conclusion The separation-free safety tube on the disposable infusion needle could instantly block the sharp needle after infusion, which reduces the needle exposure time and lowers the risk of needle stick injuries. In the meantime, the safety tube is convenient to use, and its application can shorten the time for infusion and needle disposal, consequently improving the working efficiency of nurses. As the new type safety tube has above advantages and would not raise the risk of needle slippage, it is worthy of clinical promotion.",2020,"Nevertheless, there was no statistically significant difference in the accidental slip rate of the needles as that turned out 0% in both groups ( P > 0.05).",['200 inpatients who were in need of intravenous infusion with a disposable infusion needle'],['intervention group and control group'],"['exposure time of the needles', 'accidental slip rate', 'block rate of the disposed needles']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",200.0,0.0163946,"Nevertheless, there was no statistically significant difference in the accidental slip rate of the needles as that turned out 0% in both groups ( P > 0.05).","[{'ForeName': 'Weifen', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Respiration, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}, {'ForeName': 'Qianli', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': 'Department of Respiration, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}, {'ForeName': 'Yinxin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiration, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Respiration, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiration, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Cardiothoracic Surgery, First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), 314000 Jiaxing, China.'}]",Computational and mathematical methods in medicine,['10.1155/2020/6896517'] 2198,32509046,Ultrasound-Guided Inactivation of Trigger Points Combined with Muscle Fascia Stripping by Liquid Knife in Treatment of Postherpetic Neuralgia Complicated with Abdominal Myofascial Pain Syndrome: A Prospective and Controlled Clinical Study.,"Objective To evaluate ultrasound-guided inactivation of myofascial trigger points (MTrPs) combined with abdominal muscle fascia stripping by liquid knife in the treatment of postherpetic neuralgia (PHN) complicated with abdominal myofascial pain syndrome (AMPS). Methods From January 2015 to July 2018, non-head-and-neck PHN patients in the Pain Department, The First Affiliated Hospital of Soochow University, were treated with routine oral drugs and weekly paraspinal nerve block for two weeks. Patients with 2 < VAS (visual analogue scale) score < 6 were subjects of the study. They were assigned into control group 1 (C1, n  = 33) including those with PHN and without myofascial pain syndrome (MPS) and control group 2 (C2, n  = 33) including those with PHN complicated with MPS and observation group 1 (PL, n  = 33) including those with PHN complicated with limb myofascial pain syndrome (LMPS) and observation group 2 (PA, n  = 33) including those with PHN complicated with AMPS. All groups received zero-grade treatment: routine oral drugs and weekly paraspinal nerve block. PL and PA groups were also treated step by step once a week: primary ultrasound-guided inactivation of MTrPs with dry needling, secondary ultrasound-guided inactivation of MTrPs with dry and wet needling, and tertiary ultrasound-guided dry and wet needling combined with muscle fascia stripping by liquid knife. At one week after primary treatment, patients with a VAS score > 2 proceeded to secondary treatment. If the VAS score was <2, the treatment was maintained, and so on, until the end of the four treatment cycles. Pain assessment was performed by specialized nurses at one week after each treatment, including VAS score, McGill pain questionnaire (MPQ) score, pressure pain sensory threshold (PPST), and pressure pain tolerance threshold (PPTT). VAS score was used as the main index and VAS <2 indicated effective treatment. At 3 months after treatment, outpatient and/or telephone follow-up was performed. The recurrence rate was observed and VAS > 2 was regarded as recurrence. Results At one week after primary treatment, the effective rate was 66.7% in PL group, significantly higher than that in PA group (15.2%, P < 0.05). At one week after secondary treatment, the effective rate was 100% and 37.5% in PL and PA groups, respectively, with significant difference between the groups ( P < 0.05). The effective rate increased to 90.6% in PA group at one week after tertiary treatment. At one week after the end of treatment cycles, the scores of VAS and MPQ were significantly lower in C1, PL, and PA groups than in C2 group ( P < 0.05), while PPST and PPTT were significantly higher than in C2 group ( P < 0.05). There was no significant difference between C1 group and PL group ( P > 0.05). At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). Conclusion About 57% of PHN patients with mild to moderate pain are complicated with MPS, and ultrasound-guided inactivation of MTrPs with dry and wet needling can effectively treat PHN patients complicated with LMPS. However, patients with PHN complicated with AMPS need to be treated with ultrasound-guided MTrPs inactivation combined with muscle fascia stripping by liquid knife as soon as possible.",2020,"At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). ","['Patients with 2\u2009<\u2009VAS (visual analogue scale) score < 6 were subjects of the study', 'postherpetic neuralgia (PHN) complicated with abdominal myofascial pain syndrome (AMPS', 'Postherpetic Neuralgia Complicated with Abdominal Myofascial Pain Syndrome', 'From January 2015 to July 2018, non-head-and-neck PHN patients in the Pain Department, The First Affiliated Hospital of Soochow University', 'patients with PHN complicated with AMPS']","['ultrasound-guided inactivation of myofascial trigger points (MTrPs) combined with abdominal muscle fascia stripping by liquid knife', 'Muscle Fascia Stripping by Liquid Knife', 'PHN and without myofascial pain syndrome (MPS) and control group 2 (C2, n \u2009=\u200933) including those with PHN complicated with MPS and observation group 1 (PL, n \u2009=\u200933) including those with PHN complicated with limb myofascial pain syndrome (LMPS) and observation group 2 (PA, n \u2009=\u200933) including those with PHN complicated with AMPS', 'ultrasound-guided MTrPs inactivation combined with muscle fascia stripping by liquid knife', 'Ultrasound-Guided Inactivation of Trigger Points', 'primary ultrasound-guided inactivation of MTrPs with dry needling, secondary ultrasound-guided inactivation of MTrPs with dry and wet needling, and tertiary ultrasound-guided dry and wet needling combined with muscle fascia stripping by liquid knife', 'zero-grade treatment: routine oral drugs and weekly paraspinal nerve block']","['VAS score', 'VAS score, McGill pain questionnaire (MPQ) score, pressure pain sensory threshold (PPST), and pressure pain tolerance threshold (PPTT', 'scores of VAS and MPQ', 'effective rate', 'Pain assessment', 'recurrence rate', 'PPST and PPTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0000739', 'cui_str': 'Skeletal muscle structure of abdomen'}, {'cui': 'C0185460', 'cui_str': 'Stripping of fascia'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4305047', 'cui_str': 'McGill Pain Questionnaire score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0157686,"At follow-up at 3 months after treatment, the recurrence rate was low in each group, with no significant difference between the groups ( P > 0.05). ","[{'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Lan', 'Initials': 'XL', 'LastName': 'Chang', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Si-Lan', 'Initials': 'SL', 'LastName': 'Liu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Jing-Ya', 'Initials': 'JY', 'LastName': 'Xu', 'Affiliation': 'Anesthesia Surgery Department, The First Affiliated Hospital of Suzhou University, Suzhou 215006, China.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Gou', 'Affiliation': 'Central Laboratory, Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai, Shanghai 201999, China.'}]",Pain research & management,['10.1155/2020/4298509'] 2199,32509107,"A Comparison of Muscle Activation Among the Front Squat, Overhead Squat, Back Extension and Plank.","The purpose of this study was to compare the muscle activation of the scapula, leg, and trunk among the front squat (FS), overhead squat (OHS), back extension (BE) and plank (PL). Seven recreationally trained men (age: 28 ± 3.6 years, body mass: 92 ± 26.1 kg, height: 175 ± 5.3 cm, 3-RM front squat test: 125 ± 49.8 kg, 3-RM overhead squat test: 91 ± 15.5 kg) participated in this within-subject crossover design. Two isometric exercises (plank and Biering-Sorenson back extension) were also included for trunk musculature comparisons. Neuromuscular activitation of the vastus lateralis (VL), biceps femoris (BF), thoracic region of erector spinae (ES), middle trapezius (MT), rectus abdominis (RA), external oblique (EO), serratus anterior (SA), and anterior deltoid (AD). The neuromuscular activity of the FS and OHS were analyzed using a 2 × 3 (squat variation X intensity) repeated measures analysis of variance (ANOVA). Effects were further analyzed by Bonferroni corrected paired t-tests. Results showed that AD activity was significantly greater (p < .05) during the FS compared to OHS at 65 and 95% of the 3-RM, while MT activity was significantly greater (p < .05) during the OHS than the FS at 80 and 95% of the 3-RM. ES activity was significantly greater (p< .05) during both the FS and OHS compared to the BE, but PL elicited significantly greater EO and RA activity than both the FS and OHS. These findings reveal that the FS and OHS can help facilitate the activation of muscles supporting the shoulder complex, scapula and lower back.",2020,"ES activity was significantly greater (p< .05) during both the FS and OHS compared to the BE, but PL elicited significantly greater EO and RA activity than both the FS and OHS.","['Seven recreationally trained men (age: 28 ± 3.6 years, body mass: 92 ± 26.1 kg, height: 175 ± 5.3 cm, 3-RM front squat test: 125 ± 49.8 kg, 3-RM overhead squat test: 91 ± 15.5 kg) participated in this within-subject crossover design']",['Two isometric exercises (plank and Biering-Sorenson back extension'],"['EO and RA activity', 'Neuromuscular activitation of the vastus lateralis (VL), biceps femoris (BF), thoracic region of erector spinae (ES), middle trapezius (MT), rectus abdominis (RA), external oblique (EO), serratus anterior (SA), and anterior deltoid (AD', 'MT activity', 'ES activity', 'muscle activation of the scapula, leg, and trunk among the front squat (FS), overhead squat (OHS), back extension (BE) and plank (PL', 'neuromuscular activity of the FS and OHS', 'AD activity']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0224375', 'cui_str': 'External Oblique Muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",2.0,0.0311073,"ES activity was significantly greater (p< .05) during both the FS and OHS compared to the BE, but PL elicited significantly greater EO and RA activity than both the FS and OHS.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bautista', 'Affiliation': 'Physiology of Exercise and Sport (PEXS) Laboratory, Department of Kinesiology, California State University Long Beach, Long Beach, CA, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Durke', 'Affiliation': 'Physiology of Exercise and Sport (PEXS) Laboratory, Department of Kinesiology, California State University Long Beach, Long Beach, CA, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cotter', 'Affiliation': 'Physiology of Exercise and Sport (PEXS) Laboratory, Department of Kinesiology, California State University Long Beach, Long Beach, CA, USA.'}, {'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'Escobar', 'Affiliation': 'Physiology of Exercise and Sport (PEXS) Laboratory, Department of Kinesiology, California State University Long Beach, Long Beach, CA, USA.'}, {'ForeName': 'Evan E', 'Initials': 'EE', 'LastName': 'Schick', 'Affiliation': 'Physiology of Exercise and Sport (PEXS) Laboratory, Department of Kinesiology, California State University Long Beach, Long Beach, CA, USA.'}]",International journal of exercise science,[] 2200,32509112,The Effects of Machine-Weight and Free-Weight Resistance Exercise on Hemodynamics and Vascular Function.,"The purpose of this study was to examine hemodynamic and vascular responses between machine-weight and free-weight exercise. Resistance-trained individuals were assigned to a machine-weight ( n = 13) or free-weight ( n = 15) group. Groups completed two visits consisting of their assigned exercise condition and a control (CON). A 2 × 2 × 3 repeated measures ANOVA was used to test the effects of group across condition and time on the hemodynamic parameters [cardiac output (CO), heart rate (HR), total peripheral resistance (TPR), mean arterial pressure (MAP), and stroke volume (SV)]. A 2 × 2 × 2 repeated measures ANOVA was used to test the effects of group across condition and time on the hemodynamic variable, forearm vascular conductance (FVC), as well as on vascular measures [forearm blood flow (FBF), blood flow peak, and total reactive hyperemia (RH)]. Main effects were analyzed using pairwise comparisons. The results of the present study demonstrate that both machine-weight and free-weight exercise produce similar ( p > 0.05) alterations in hemodynamics and vascular function. Specifically, during recovery both groups demonstrated significant ( p ≤ 0.05) increases in measures of hemodynamics such as CO, HR and FVC, as well as significant ( p ≤ 0.05) decreases in TPR, MAP, and SV. Measures of vascular function such as FBF, blood flow peak, and total RH were also significantly ( p ≤ 0.05) increased during recovery. Therefore, this study suggests that either machine weight or free-weight exercise may induce acute hemodynamic and vascular benefits, which may reduce the risk of cardiovascular disease (CVD) and CVD events.",2020,"Specifically, during recovery both groups demonstrated significant ( p ≤ 0.05) increases in measures of hemodynamics such as CO, HR and FVC, as well as significant ( p ≤ 0.05) decreases in TPR, MAP, and SV.",[],"['machine weight or free-weight exercise', 'machine-weight and free-weight exercise', 'Machine-Weight and Free-Weight Resistance Exercise', 'exercise condition and a control (CON']","['hemodynamic variable, forearm vascular conductance (FVC), as well as on vascular measures [forearm blood flow (FBF), blood flow peak, and total reactive hyperemia (RH', 'hemodynamic and vascular responses', 'vascular function such as FBF, blood flow peak, and total RH', 'hemodynamic parameters [cardiac output (CO), heart rate (HR), total peripheral resistance (TPR), mean arterial pressure (MAP), and stroke volume (SV', 'hemodynamics and vascular function', 'measures of hemodynamics such as CO, HR and FVC', 'TPR, MAP, and SV', 'Hemodynamics and Vascular Function']",[],"[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429854', 'cui_str': 'Vascular measure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C1098484', 'cui_str': 'TPR protein, human'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",,0.0429813,"Specifically, during recovery both groups demonstrated significant ( p ≤ 0.05) increases in measures of hemodynamics such as CO, HR and FVC, as well as significant ( p ≤ 0.05) decreases in TPR, MAP, and SV.","[{'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Marshall', 'Affiliation': 'Cardiovascular Dynamics Laboratory, School of Health Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Parks', 'Affiliation': 'Cardiovascular Dynamics Laboratory, School of Health Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Yu Lun', 'Initials': 'YL', 'LastName': 'Tai', 'Affiliation': 'Cardiovascular Dynamics Laboratory, School of Health Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'J Derek', 'Initials': 'JD', 'LastName': 'Kingsley', 'Affiliation': 'Cardiovascular Dynamics Laboratory, School of Health Sciences, Kent State University, Kent, OH, USA.'}]",International journal of exercise science,[] 2201,32509290,Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh.,"Background Topical emollient therapy can improve neonatal health and growth and potentially provides an additional avenue for augmenting the provision of nutrition to children with severe acute malnutrition (SAM). We hypothesised that topical treatment of hospitalised children with SAM using sunflower seed oil (SSO), in addition to standard-of-care for SAM, would improve skin barrier function and weight gain, reduce risk of infection, and accelerate clinical recovery. Methods We conducted a randomised, two-arm, controlled, unblinded clinical trial in 212 subjects aged 2 to 24 months who were admitted for care of SAM at the 'Dhaka Hospital' of icddr,b during January 2016 to November 2017. Enrollment was age-stratified into 2 to <6 months and 6 to 24 months age groups in a 1:2 ratio. All children received SAM standard-of-care, and the SSO group was also treated with 3 g of SSO per kg body weight three times daily for 10 days. Primary outcome was rate of weight gain over the 10-day study period. Secondary endpoints included rate of nosocomial infection, time to recovery from acute illness, skin condition score, rate of transepidermal water loss (TEWL) and C-reactive protein (CRP) level. Results Rate of weight gain was higher in the SSO than the control group (adjusted mean difference, AMD = 0.90 g/kg/d, 95% confidence interval (CI) = -1.22 to 3.03 in the younger age stratum), but did not reach statistical significance. Nosocomial infection rate was significantly lower in the SSO group in the older age stratum (adjusted odds ratio (OR) = 0.41, 95% CI = 0.19 to 0.85; P  = 0.017), but was comparable in the younger age stratum and overall. Skin condition score improved (AMD = -14.88, 95% CI = -24.12 to -5.65, P  = 0.002) and TEWL was reduced overall (AMD = -2.59, 95% CI = -3.86 to -1.31, P  < 0.001) in the SSO group. Reduction in CRP level was significantly greater in the SSO group (median: -0.28) than the control group (median 0.00) ( P  = 0.019) in the younger age stratum. Conclusions Topical therapy with SSO was beneficial for children with SAM when applied as adjunctive therapy. A community-based trial with a longer intervention period is recommended to validate these results. Trial registration ClinicalTrials.gov: NCT02616289.",2020,"Reduction in CRP level was significantly greater in the SSO group (median: -0.28) than the control group (median 0.00) ( P  = 0.019) in the younger age stratum. ","['severe acute malnutrition in children under two', 'children with SAM', 'hospitalised children with SAM using', ""212 subjects aged 2 to 24 months who were admitted for care of SAM at the 'Dhaka Hospital' of icddr,b during January 2016 to November 2017"", 'children with severe acute malnutrition (SAM']","['Topical emollient therapy', 'SSO', 'sunflower seed oil (SSO']","['Nosocomial infection rate', 'TEWL', 'Rate of weight gain', 'CRP level', 'rate of nosocomial infection, time to recovery from acute illness, skin condition score, rate of transepidermal water loss (TEWL) and C-reactive protein (CRP) level', 'rate of weight gain', 'skin barrier function and weight gain, reduce risk of infection', 'Skin condition score']","[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013983', 'cui_str': 'Emollient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",212.0,0.22856,"Reduction in CRP level was significantly greater in the SSO group (median: -0.28) than the control group (median 0.00) ( P  = 0.019) in the younger age stratum. ","[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Shahunja', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Iqbal', 'Initials': 'MI', 'LastName': 'Hossain', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Mahfuz', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Kendall', 'Affiliation': 'GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Krishan', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Crowther', 'Affiliation': 'JMC Scientific Consulting Ltd, Egham, Surrey, UK.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Darmstadt', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.'}]",Journal of global health,['10.7189/jogh.10.010414'] 2202,32509293,"Impact of mobile health-enhanced supportive supervision and supply chain management on appropriate integrated community case management of malaria, diarrhoea, and pneumonia in children 2-59 months: A cluster randomised trial in Eastern Province, Zambia.","Background Despite progress made over the past twenty years, child mortality remains high, with 5.3 million children under five years having died in 2018 globally. Pneumonia, diarrhoea, and malaria remain among the commonest causes of under-five mortality; contributing 15%, 8%, and 5% of global mortality respectively. Recent evidence shows that integrated community case management (iCCM) of pneumonia, diarrhoea, and malaria can reduce under-five mortality. However, despite growing evidence of the effectiveness of iCCM, there are implementation challenges, especially stock out of iCCM commodities and inadequate supportive supervision of community health workers (CHWs). This study aimed to address these two key challenges to successful iCCM implementation by using mobile health (mHealth) technology. Methods This cluster randomised controlled trial compared health centre catchment areas (clusters) where CHWs and their supervisors implemented mHealth-enhanced iCCM supportive supervision and supply chain management vs clusters implementing iCCM as per current Zambian guidelines. CHWs in intervention clusters used community DHIS2 platform on mobile phones to report on a weekly basis children with iCCM conditions and make requisitions for iCCM commodities. Their supervisors received electronic reports on disease caseloads and monthly automated supervision reminders. The supervisors on receipt of requisitions, organized the medical supplies and notified CHWs for collection. Intention-to-treat analysis on the primary outcome, the percentage of children aged 2-59 months receiving appropriate treatment for malaria, pneumonia, or diarrhoea from an iCCM trained CHW, was performed using a generalized linear model. Prevalence ratios and 95% confidence intervals comparing the prevalence of appropriate treatment in the intervention and control groups were calculated using log binomial regression with an exchangeable correlation matrix, adjusted for clustering by health facility. Results In the intervention clusters, 61.3% (98/160) of expected monthly supervision visits took place vs 52.0% (78/150) in the controls. A total of 3690 children 2-59 months old presented with malaria, diarrhoea, or pneumonia. In the intervention group, 65.9% (1,252/1,899) of children received appropriate care for iCCM conditions, compared to 63.3% (1,134/1,791) in the control group. The mHealth intervention was associated with 18.0% improvement in supportive supervision and 21.0% increase in appropriate treatment for pneumonia; these changes were not statistically significant. There was a 2-3-fold increase in the proportion of CHWs receiving supplies ordered: prevalence ratios ranged from 2.82 (confidence interval (CI) = 1.50, 5.30) to 3.01 (95% CI = 1.29, 7.00) depending on the particular commodity. Conclusion This study was unable to determine whether using mHealth technology would strengthen supervision and supply chain management of iCCM commodities for community-level workers. There was no statistically significant effect of mHealth enhanced iCCM on appropriate diagnosis and treatment for children with malaria, pneumonia, and diarrhoea in rural Zambia. Longer term longitudinal studies are required to determine the impact of mHealth enhanced iCCM on health outputs and outcomes. Trial registration ClinicalTrials.gov, NCT02866097.",2020,"There was no statistically significant effect of mHealth enhanced iCCM on appropriate diagnosis and treatment for children with malaria, pneumonia, and diarrhoea in rural Zambia.","['malaria, diarrhoea, and pneumonia in children 2-59 months', '3690 children 2-59 months old presented with malaria, diarrhoea, or pneumonia', 'community-level workers', 'Eastern Province, Zambia', 'children with malaria, pneumonia, and diarrhoea in rural Zambia']",['mobile health-enhanced supportive supervision and supply chain management'],"['Prevalence ratios', 'malaria, pneumonia, or diarrhoea', 'supportive supervision', 'Pneumonia, diarrhoea, and malaria remain']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]",3690.0,0.0792636,"There was no statistically significant effect of mHealth enhanced iCCM on appropriate diagnosis and treatment for children with malaria, pneumonia, and diarrhoea in rural Zambia.","[{'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Biemba', 'Affiliation': 'National Health Research Authority, Lusaka, Zambia.'}, {'ForeName': 'Boniface', 'Initials': 'B', 'LastName': 'Chiluba', 'Affiliation': 'Zambian Center for Applied Health Research and Development (ZCAHRD), Lusaka, Zambia.'}, {'ForeName': 'Kojo', 'Initials': 'K', 'LastName': 'Yeboah-Antwi', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Vichael', 'Initials': 'V', 'LastName': 'Silavwe', 'Affiliation': 'Ministry of Health, Child Health Unit, Lusaka, Zambia.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lunze', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Centre, Massachusetts, USA.'}, {'ForeName': 'Rodgers K', 'Initials': 'RK', 'LastName': 'Mwale', 'Affiliation': ""United Nations Children's Fund (UNICEF), Lusaka, Zambia.""}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'MacLeod', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.'}]",Journal of global health,['10.7189/jogh.10.010425'] 2203,32509319,Evaluation of pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia [EVADE]: a randomised controlled feasibility trial.,"Background The valsalva manoeuvre is an internationally recommended initial treatment for supraventricular tachycardia (SVT). The pre-hospital use of a valsalva assist device, to help deliver this manoeuvre, could improve cardioversion rates and reduce the need for patients to attend hospital. Methods We conducted a randomised controlled feasibility trial comparing ambulance clinician use of a valsalva assist device versus standard care to treat adult patients presenting to an ambulance service in the south west of England. Eligible consenting participants were randomised 1:1 to device or standard care with trial procedures mirroring a proposed definitive trial.Feasibility was assessed upon ambulance clinician and participant recruitment rates and feedback, data completeness and potential future primary outcome rates. Results Over a 6 months period (1 July to 31 December 2018), 276 (23%) of 1183 eligible ambulance clinicians were trained and they recruited 34 participants; approximately 10% of patients presenting with suspected SVT during that time. Seventeen participants were randomised to each arm and all underwent their allocated valsalva strain method. All trial data and 63/68 (93%) of pre and post-valsalva ECGs were available. Seven (21%) participants had ineligible initial rhythms on retrospective expert ECG review. Valsalva assist device use was associated with cardioversion and non-conveyance in 4 (24%) and 2 (12%) participants respectively. No participants assigned to standard care were cardioverted and all were conveyed. Participant feedback highlighted the challenges of retaining trial information during an SVT attack. Conclusions The trial achieved efficient clinician training, randomisation and data collection, and there was an encouraging effect signal associated with device use. However, trial design changes should be considered to address the relatively small proportion of eligible patients recruited and challenges identified with consent and confirmation of cardioversion as a primary outcome. Trial registration The trial was registered with ClinicalTrials.gov (NCT03514628) on 2 May 2018.",2020,"The trial achieved efficient clinician training, randomisation and data collection, and there was an encouraging effect signal associated with device use.","['eligible ambulance clinicians were trained and they recruited 34 participants; approximately 10% of patients presenting with suspected SVT during that time', 'adult patients presenting to an ambulance service in the south west of England', 'Seven (21%) participants had ineligible initial rhythms on retrospective expert ECG review', 'Seventeen participants', 'Eligible consenting participants']","['valsalva assist device versus standard care', 'valsalva assist device']","['cardioversion rates', 'ambulance clinician and participant recruitment rates and feedback, data completeness and potential future primary outcome rates']","[{'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",17.0,0.265604,"The trial achieved efficient clinician training, randomisation and data collection, and there was an encouraging effect signal associated with device use.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Appelboam', 'Affiliation': ""University of Exeter Medical School, St Luke's, Exeter, Devon UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'South West Ambulance Service Foundation Trust, Abbey Court, Eagle Way, Exeter, Devon UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ewings', 'Affiliation': ""University of Exeter Medical School, St Luke's, Exeter, Devon UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': 'South West Ambulance Service Foundation Trust, Abbey Court, Eagle Way, Exeter, Devon UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-020-00616-y'] 2204,32513290,A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol.,"OBJECTIVES To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protocol, Additional file 1). The rationale is that TPE can remove interleukins-3, 6, 8, 10, interferon-gamma and tumor necrosis factor-alpha. Thus, it may reduce the cytokine release syndrome associated with fulminant COVID-19 disease. TRIAL DESIGN Pilot, interventional, open-label, randomized controlled multicenter trial. PARTICIPANTS Inclusion criteria are: 1) age ≥ 18 years old; 2) intubation and intensive care unit (ICU) admission; 3) serious and/or life-threatening COVID-19 (please, refer to the full protocol, Additional file 1). SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland). Exclusion criteria are: 1) previous allergic reaction to plasma exchange or its ingredients (i.e., sodium citrate), 2) two consecutive negative RT-PCR tests for SARS-CoV-2 at least 24 hours apart, 3) mild COVID-19 not requiring ICU admission and 4) terminally ill patients receiving palliative care. The primary site will be King Saud Medical City (KSMC), Riyadh, Kingdom of Saudi Arabia (KSA). Also, the study will run in ICUs (Ministry of Health Cluster 1; Riyadh) and other centers in KSA pending their institutional review board (IRB) approval. INTERVENTIONS AND COMPARATOR The intervention group will receive TPE, plus empiric treatment for COVID-19. TPE is administered using the Spectra Optia TM Apheresis System equipped with the Depuro D2000 Adsorption Cartridge (Terumo BCT Inc., USA). The first dose is 1.5 plasma volumes, followed by one plasma volume on alternate days or daily for five to seven total treatments. Spectra Optia TM Apheresis System operates with acid-citrate dextrose anticoagulant (ACDA) as per Kidney Disease Improving Global Outcomes (KDIGO) 2019 guidelines. Plasma is replaced with albumin 5% or fresh frozen plasma in patients with coagulopathy (prothrombin time >37 seconds; international normalized ratio >3; activated partial thromboplastin time >100 or fibrinogen level <100 mg/d). TPE sessions are performed daily over four hours and laboratory markers measured daily. The comparators are controls not receiving TPE but usual empiric treatment for COVID-19 as per institutional, national and international recommendations. Both groups will receive standard ICU supportive care. MAIN OUTCOMES Primary study end-point is 28-day mortality and safety of TPE in serious and/or life-threatening COVID-19. Safety will be evaluated by the documentation of any pertinent adverse and/or serious adverse effects related to TPE as per institutional, national and international (Food and Drug Administration) guidelines. Secondary outcomes are: i) improvement in Sequential Organ Function Assessment (SOFA) score ; ii) changes in inflammatory markers: serum C-reactive protein, lactate dehydrogenase, ferritin, d-dimers and interleukin-6; iii) days on mechanical ventilation and ICU length of stay. RANDOMIZATION Eligible consented patients are randomized (1:1 allocation) after stratification by ICU center and two PaO2/FIO2 ratio categories (> 150 and ≤ 150). Randomization occurs in variable block sizes of four to eight patients. A web-based randomization service, randomize.net, is used to allocate patients to their respective strata prior to the intervention or control therapy. BLINDING (MASKING) Given the visibility of TPE machinery, the intervention will be unblinded; hence, no enrollment concealment will be expedited. The lack of allocation concealment will be mitigated by several measures (please, refer to the full protocol, Additional file 1). NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) This pilot randomized trial aims to recruit a convenience sample of patients with serious and/or life-threatening COVID-19. Therefore, at least 20 patients are to be randomized to each group per participating center. We are hoping to consent and randomize approximately 60 patients in each group over a 3 to 6 months period giving a total of 120 participants. TRIAL STATUS The protocol version 1 was approved 29/04/2020. Recruitment is ongoing, and began on 01/05/2020. We estimate completion by 29/10/2020. TRIAL REGISTRATION Registered at ISRCTN on 18/05/2020 (ISRCTN21363594; doi.10.1186/ ISRCTN21363594). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland).","['Exclusion criteria are: 1) previous allergic reaction to plasma exchange or its ingredients (i.e., sodium citrate), 2) two consecutive negative RT-PCR tests for SARS-CoV-2 at least 24 hours apart, 3) mild COVID-19 not requiring ICU admission and 4) terminally ill patients receiving palliative care', 'Inclusion criteria are: 1) age ≥ 18 years old; 2) intubation and intensive care unit (ICU) admission; 3) serious and/or life-threatening COVID-19 (please, refer to the full protocol, Additional file 1', '60 patients in each group over a 3 to 6 months period giving a total of 120 participants', 'serious SARS CoV-2 disease (COVID-19', 'patients with serious and/or life-threatening COVID-19', 'adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality']","['TPE', 'acid-citrate dextrose anticoagulant (ACDA', 'TPE, plus empiric treatment for COVID-19', 'therapeutic plasma exchange (TPE']","['28-day mortality and safety of TPE in serious and/or life-threatening COVID-19', 'i) improvement in Sequential Organ Function Assessment (SOFA) score ; ii) changes in inflammatory markers: serum C-reactive protein, lactate dehydrogenase, ferritin, d-dimers and interleukin-6; iii) days on mechanical ventilation and ICU length of stay']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0142825', 'cui_str': 'sodium citrate'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0050552', 'cui_str': 'acid citrate dextrose'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0749647', 'cui_str': 'Empiric treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",120.0,0.272786,"SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland).","[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Faqihi', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alharthy', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alodat', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Daood', 'Initials': 'D', 'LastName': 'Asad', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Aletreby', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsogiannis', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Brindley', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Karakitsos', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. karakitsosdimitrios@gmail.com.'}]",Trials,['10.1186/s13063-020-04454-4'] 2205,32513291,"A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial (""MoVo-App"").","BACKGROUND Interventions designed to increase the level of physical activity are crucial in the treatment of patients with musculoskeletal conditions. The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity. The aim of this study is to evaluate whether a MoVo-based app (MoVo-App) subsequent to MoVo-LISA during orthopedic inpatient care can support people to increase and maintain their amount of physical activity. METHODS/DESIGN In this parallel-group randomized controlled trial, patients with musculoskeletal disorders will be randomized to either (a) a combination of the group-based intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app. The intervention group will receive the MoVo-App after discharge from inpatient rehabilitation. They receive help to increase and maintain their level of physical activity (initiated by the group program) by tracking their health goals, activity plans, major barriers, and barrier management that were developed during the group-based program. We will recruit 224 initially minimally active participants during orthopedic rehabilitation care. Outcomes are assessed at clinic admission; discharge; 6 weeks; and 3 (post-treatment), 6, and 12 months after discharge (follow-up). The primary outcome is sport activity (active/inactive and minutes of activity) at 6-month follow-up. Secondary outcomes are movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression). To evaluate intervention effects, linear mixed effects models (both on intention-to-treat basis with an additional per-protocol analysis) will be conducted with each outcome variable and with time as the within-subjects factor and group as the between-subjects factor, along with all two-way interactions and accounting for covariates as fixed effects. DISCUSSION This is the first evaluation of the effectiveness of an app in combination with a face-to-face group intervention to promote physical activity. The approach of using an app in addition to an effective face-to-face intervention program, both based on the MoVo model, might sustain positive intervention effects introduced in routine health care. TRIAL REGISTRATION The trial ""A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomized controlled trial"" is registered at the World Health Organization International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS), DRKS00014814. Registered on 18 October 2018; URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014814.",2020,The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity.,"['patients with musculoskeletal disorders', '224 initially minimally active participants during orthopedic rehabilitation care', 'patients with musculoskeletal conditions']","['smartphone-based psychological intervention', 'MoVo-based app (MoVo-App) subsequent to MoVo-LISA', 'intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app']","['sport activity (active/inactive and minutes of activity', 'physical activity', 'movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",224.0,0.0913607,The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity.,"[{'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry and Psychotherapy Medical Center, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Wurst', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Paganini', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany. sarah.paganini@sport.uni-freiburg.de.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hohberg', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kinkel', 'Affiliation': 'Schwarzwaldkliniken Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Göhner', 'Affiliation': 'Department of Health Psychology, Catholic University of Applied Sciences, Freiburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ramsenthaler', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Fuchs', 'Affiliation': 'Department of Sport Psychology, Institute of Sports and Sport Science, University of Freiburg, Schwarzwaldstrasse 175, 79117, Freiburg, Germany.'}]",Trials,['10.1186/s13063-020-04438-4'] 2206,32513294,Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design.,"BACKGROUND The symptom severity of a substantial group of schizophrenia patients (30-40%) does not improve through pharmacotherapy with antipsychotic medication, indicating a clear need for new treatment options to improve schizophrenia outcome. Meta-analyses, genetic studies, randomized controlled trials, and post-mortem studies suggest that immune dysregulation plays a role in the pathophysiology of schizophrenia. Some anti-inflammatory drugs have shown beneficial effects on the symptom severity of schizophrenia patients. Corticosteroids are effective in various chronic inflammatory and autoimmune disorders. Prednisolone, a potent glucocorticosteroid, has minor mineral-corticosteroid potencies and can adequately pass the blood-brain barrier and its side effects and safety profile are well known. Therefore, the effect of prednisolone can be studied as a proof of concept for immune modulation as a treatment for schizophrenia. METHODS/DESIGN In total, 90 subjects aged 18-70 years and diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.x) or psychosis not otherwise specified (NOS; 298.9) will be included. The time interval between the onset of psychosis and study entry should not exceed 7 years. Patients will be randomized 1:1 to either prednisolone or placebo daily for a period of 6 weeks in addition to a stable dose of antipsychotic medication. Study medication will be initiated at 40 mg for 3 days, after which it will be tapered down within 6 weeks after initiation, following inflammatory bowel diseases treatment guidelines. Primary outcome is change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of treatment. Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers. Secondary outcomes are a 4- and 6-month follow-up assessment of PANSS, BACS, and GAF scores and immunological biomarkers. Additionally, a subgroup of patients will be included in the magnetic resonance imaging (MRI) part of the study where MR spectroscopy and structural, functional, and diffusion MRI will be conducted. DISCUSSION It is expected that prednisolone addition to current antipsychotic medication use will reduce symptom severity and will improve cognition when compared to placebo. TRIAL REGISTRATION ClinicalTrials.gov, NCT02949232 and NCT03340909. Registered 31 October 2016 and 14 November 2017. EudraCT-number 2014-000520-14 and 2017-000163-32.",2020,"Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers.","['patients with recent-onset psychotic disorder', 'schizophrenia patients', 'Registered 31 October 2016\xa0and 14 November 2017', '90 subjects aged 18-70\u2009years and diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.x) or psychosis not otherwise specified (NOS; 298.9']","['Corticosteroids', 'Prednisolone', 'prednisolone or placebo', 'prednisolone', 'antipsychotic medication', 'placebo']","['4- and 6-month follow-up assessment of PANSS, BACS, and GAF scores and immunological biomarkers', 'Calgary Depression Scale for Schizophrenia (CDS', 'Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms', 'Cognitive functioning', 'change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",90.0,0.285186,"Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers.","[{'ForeName': 'Lyliana G', 'Initials': 'LG', 'LastName': 'Nasib', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Lnasib@umcutrecht.nl.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Cognitive Neurosciences, Department of Biomedical Sciences of Cells & Systems, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter-van Rossum', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': ""Reinier van Arkel, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Shiral S', 'Initials': 'SS', 'LastName': 'Gangadin', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Priscilla P', 'Initials': 'PP', 'LastName': 'Oomen', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Gurmeet', 'Initials': 'G', 'LastName': 'Judge', 'Affiliation': 'GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Renske E', 'Initials': 'RE', 'LastName': 'Blom', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jurjen J', 'Initials': 'JJ', 'LastName': 'Luykx', 'Affiliation': 'Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nico J M', 'Initials': 'NJM', 'LastName': 'van Beveren', 'Affiliation': 'Antes Center for Mental Health Care, Rotterdam, The Netherlands.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Veen', 'Affiliation': 'GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Rune A', 'Initials': 'RA', 'LastName': 'Kroken', 'Affiliation': 'Norment, Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Erik L', 'Initials': 'EL', 'LastName': 'Johnsen', 'Affiliation': 'Norment, Division of Psychiatry, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway.'}]",Trials,['10.1186/s13063-020-04365-4'] 2207,32513299,"Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES Patients with severe COVID-19 often suffer from significant pulmonary fibrosis. Although the pathogenesis of pulmonary fibrosis has not been fully explained, the signal pathways and cytokines involved are very similar to hepatic fibrosis. This has been successfully treated with the Anluohuaxian Pill, a proprietary Chinese medicine composed of a variety of Chinese herbal medicines. The aim of this study is to evaluate the efficacy and safety of Anluohuaxian in the treatment of pulmonary fibrosis in patients with severe COVID-19. TRIAL DESIGN This is a prospective, multicenter, open, randomized controlled trial. The distribution ratio was 2:1, 500 cases in the experimental group and 250 cases in the control group. PARTICIPANTS Minimum Age: 18 Years Maximum Age: 80 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Inclusion Criteria: 1.Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);2.Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;3.High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);4.Voluntarily participate in research and sign informed consent. EXCLUSION CRITERIA 1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or dependence;5.Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;6.Researchers consider it inappropriate to participate in research;7.Participating in other clinical research. This mutli-centre RCT will be undertaken in 9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital. INTERVENTION AND COMPARATOR The research drug is Anluohuaxian Pill, which is provided by Senlong Pharmaceutical Co., Ltd. The basic therapeutic drugs for COVID-19 involved in the study include antiviral drugs. Brands can be selected according to the treatment routines of each research center to facilitate the improvement of treatment compliance. MAIN OUTCOMES Primary Outcome Measure: 1.Changes in high-resolution computer tomography of the lung Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography [Time Frame: 3 months] 2.Change in 6-minute walking distance [Time Frame: 3 months] RANDOMISATION: In this study, the central randomization system (IWRS, an interactive network response system based on network) is used to randomise the groups. The subjects who met the entry criteria were randomly divided into the experimental group and the control group according to the proportion of 2:1. In this study, the block randomized grouping method is used, and the block length is 6. The random grouping program is set up by statistical and computer professionals in the randomization process. BLINDING (MASKING) This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2 (Anluohuaxian combined with regular treatment group):1 (regular treatment group). TRIAL STATUS Protocol version number 3.0, 10th April 2020. The recruitment has not yet started. Actual Study Start Date: April 1, 2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04334265. Registered on 3 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,is negative twice after the treatment,"['subjects who met the entry criteria', 'patients with severe Coronavirus disease 2019- a multicenter', 'Patients with severe COVID-19 often suffer from significant pulmonary fibrosis', 'Registered on 3 April 2020', '1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or', 'Protocol version number 3.0, 10th April 2020', 'Minimum Age: 18 Years Maximum Age', ""9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital"", '750 patients', 'Healthy Volunteers', '2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION', 'patients with severe COVID-19', '80 Years Sex']","['Anluohuaxian', 'azathioprine, cyclophosphamide, interferon-γ', 'Anluohuaxian combined with regular treatment group):1 (regular treatment group', 'dependence;5.Have']","['distribution ratio', 'efficacy and safety', 'Efficacy and safety', '6-minute walking distance']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0859004,is negative twice after the treatment,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Que', 'Affiliation': 'Department of Respiratory Disease, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. zhaohong_pufh@bjmu.edu.cn.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}]",Trials,['10.1186/s13063-020-04399-8'] 2208,32513424,"Glutamatergic Contribution to Probabilistic Reasoning and Jumping to Conclusions in Schizophrenia: A Double-Blind, Randomized Experimental Trial.","BACKGROUND Impaired probabilistic reasoning and the jumping-to-conclusions reasoning bias are hallmark features of schizophrenia (SCZ), yet the neuropharmacological basis of these deficits remains unclear. Here we tested the hypothesis that glutamatergic neurotransmission specifically contributes to jumping to conclusions and impaired probabilistic reasoning in SCZ. METHODS A total of 192 healthy participants received either NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo in a randomized, double-blind, between-subjects design. In addition, we tested 32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission. All experiments employed two versions of a probabilistic reasoning (beads) task, which required participants to either sample individual amounts of sensory information to infer correct decisions or provide explicit probability estimates for presented sensory information. Our task instantiations assessed both information sampling and explicit probability estimates in different probabilistic contexts (easy vs. difficult conditions) and changing sensory information through random transitions among easy, difficult, and ambiguous trial types. RESULTS Following administration of D-cycloserine, haloperidol, and bromocriptine, healthy participants displayed data-gathering behavior that was normal compared with placebo and was adequate in the context of all employed task conditions and trial level difficulties. However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information. These effects were mirrored in patients with SCZ performing the same versions of the beads task. CONCLUSIONS Our findings provide novel neuropharmacological evidence linking reduced glutamatergic neurotransmission to impaired information sampling and to disrupted probabilistic reasoning, namely to overweighting of sensory evidence, in patients with SCZ.",2020,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","['32 healthy control participants matched to 32 psychotic inpatients with SCZ-a state associated with compromised probabilistic reasoning due to reduced glutamatergic neurotransmission', 'Schizophrenia', '192 healthy participants', 'healthy participants receiving', 'patients with SCZ']","['probabilistic reasoning (beads) task', 'NMDA receptor agonists/antagonists (D-cycloserine/dextromethorphan), dopamine type 2 receptor agonists/antagonists (bromocriptine/haloperidol), or placebo', 'D-cycloserine, haloperidol, and bromocriptine', 'dextromethorphan', 'placebo']","['data-gathering behavior', 'probability estimates, and overweighting of sensory information']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",192.0,0.404789,"However, healthy participants receiving dextromethorphan displayed a jumping-to-conclusions bias, abnormally increased probability estimates, and overweighting of sensory information.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany. Electronic address: wolfgang.strube@med.uni-muenchen.de.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marshall', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Quattrocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Department of Neurology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Camelia Lucia', 'Initials': 'CL', 'LastName': 'Cimpianu', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ulbrich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schneider-Axmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig Maximillian University, Munich, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics of the University Augsburg, Bezirkskrankenhaus Augsburg, University of Augsburg, Augsburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bestmann', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom; Wellcome Centre for Human Neuroimaging, UCL Queen Square Institute of Neurology, Queen Square, London, United Kingdom.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.03.018'] 2209,32513460,Effect of Korean folk music intervention on schizophrenia inpatients' emotional behavior and interpersonal relationship functioning.,"Schizophrenia can lead to inappropriate emotional behavior and issues with interpersonal relationship functioning as it becomes chronic. This study aimed to determine the effects of a Korean folk music therapy program on the emotional behavior and interpersonal relationship functioning of patients with schizophrenia. Twenty inpatients with schizophrenia in a psychiatric ward in Daegu and North Gyeongsang Province were included in the experimental group, and 24 in the control group. The experimental group participated in a 15-session music therapy program, with two 50-minute sessions per week. For hypothesis testing, Wilks' Lambda based on sphericity testing was used to perform repeated measures ANOVA. The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.",2020,"The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.","['patients with schizophrenia', 'Twenty inpatients with schizophrenia in a psychiatric ward in Daegu and North Gyeongsang Province were included in the experimental group, and 24 in the control group']","['Korean folk music intervention', 'Korean folk music therapy program', '15-session music therapy program']","['interpersonal relationship functioning', 'emotional behavior and interpersonal relationship functioning', 'levels of emotional behavior', ""schizophrenia inpatients' emotional behavior and interpersonal relationship functioning""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",20.0,0.0259774,"The experimental group showed statistically significantly higher levels of emotional behavior (F = 5.814, p < .020) and interpersonal relationship functioning (F = 21.72, p < .001) than the control group, indicating that the Korean folk music therapy program was an effective intervention.","[{'ForeName': 'Kyung Ja', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Han-Il Hospital, South Korea. Electronic address: byoung7273@hanmail.net.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: khl645@kmu.ac.kr.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.02.002'] 2210,32513473,Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research.,"Intervention studies conducted in caregivers often focus on improving mental health. Consequently, researchers may discover incidental findings like elevated depressive symptoms. Researchers have an ethical obligation to report incidental findings to participants, but no protocols exist for reporting behavioral health symptoms. The purpose of this paper was to describe a protocol for reporting elevated depressive symptoms to participants, based on the protocol used in a national randomized clinical trial of stress-reduction methods for 348 grandmothers raising grandchildren. Each questionnaire included the CES-D scale, and was scored immediately after completion. We established a cut-off score of 30 based on previous research. A registered nurse on the research team called participants with scores over 30 and ascertained whether the participant 1) was aware of the problem and 2) had sought help, and then offered additional resources. Overall, 94 (27%) participants had a CES-D score > 30. The majority (91%) were aware of the problem. About a third of the participants were on medication for their symptoms, and a third were seeing a therapist. Nine participants were not aware they had depressive symptoms. This paper outlines the ethical premise for developing our protocol, details of protocol development, and discussion for how research teams can apply this protocol to their work.",2020,The majority (91%) were aware of the problem.,['348 grandmothers raising grandchildren'],[],"['CES-D scale', 'mental health', 'depressive symptoms']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0337548', 'cui_str': 'Grandchild'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",9.0,0.122803,The majority (91%) were aware of the problem.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Wallace', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America. Electronic address: Mkw47@case.edu.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Jeanblanc', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Musil', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.04.005'] 2211,32513480,The efficacy of early postoperative enteral immunonutrition on T-lymphocyte count: A randomised control study in low-risk cardiac surgery patients.,"BACKGROUND Patients undergoing cardiac surgery have a pronounced immune response that leads to a reduction in cellular immunity. Immune-modulating nutritional supplements are considered to be beneficial for patients undergoing major surgery. However, due to the lack of studies in the cardiac surgery population, the effect of immunonutrition remains unclear in this patient group. OBJECTIVE Our purpose was to research the efficacy of early postoperative enteral immunonutrition on T-lymphocyte count in the cardiac surgery population. METHODS This was a randomised control study of low operative risk adult patients, who underwent elective cardiac surgery. These patients were randomised into immunonutrition and control groups. The immunonutrition group was supplemented with immune nutrients for five postoperative days. The counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations were determined on the day of surgery and on the sixth postoperative day. RESULTS Fifty-five patients were enrolled in the study, the mean age was 69.7 ± 6.3 years, 28 (50.9%) of them were males, the median operative risk was 1.75%. Twenty-seven (49.1%) were randomised into the immunonutrition group. The control and the immunonutrition groups were similar before the intervention. The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56 (∗10 9 /l), p = 0.035 and 1.02 ± 0.36 vs. 0.80 ± 0.43 (∗10 9 /l), p = 0.048, respectively. Regression analysis was performed to determine the efficacy of the immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts were increased to 0.264 (∗10 9 /l), p = 0.039 and 0.232 (∗10 9 /l), p = 0.021, respectively. CONCLUSIONS Early postoperative immunonutrition increases the count of the CD3+ and CD4+ T cells in cardiac surgical patients. Clinical trials identifier number: NCT04047095.",2020,The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56,"['Twenty-seven (49.1', 'patients undergoing major surgery', 'cardiac surgery population', 'low operative risk adult patients, who underwent elective cardiac surgery', 'cardiac surgical patients', 'Patients undergoing cardiac surgery', 'low-risk cardiac surgery patients', 'Fifty-five patients were enrolled in the study, the mean age was 69.7\xa0±\xa06.3 years, 28 (50.9%) of them were males']","['Immune-modulating nutritional supplements', 'early postoperative enteral immunonutrition']","['counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations', 'counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts', 'count of the CD3+ and CD4+ T cells', 'counts of the CD3+ T cells and CD4+ T cells', 'median operative risk', 'T-lymphocyte count']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1167909', 'cui_str': 'T lymphocyte count'}]",55.0,0.043517,The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56,"[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Svetikiene', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: marija.svetikiene@santa.lt.'}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Ringaitiene', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: donata.ringaitiene@santa.lt.'}, {'ForeName': 'Jevgenija', 'Initials': 'J', 'LastName': 'Vezeliene', 'Affiliation': 'Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: jevgenija.vezeliene@santa.lt.'}, {'ForeName': 'Viktoras', 'Initials': 'V', 'LastName': 'Isajevas', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: viktoras.isajevas@santa.lt.'}, {'ForeName': 'Dainius', 'Initials': 'D', 'LastName': 'Trybe', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: trybe.dainus@gmail.com.'}, {'ForeName': 'Vaidas', 'Initials': 'V', 'LastName': 'Vicka', 'Affiliation': 'Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania; Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: vaidas555@gmail.com.'}, {'ForeName': 'Radvile', 'Initials': 'R', 'LastName': 'Malickaite', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: radvile.malickaite@santa.lt.'}, {'ForeName': 'Laimute', 'Initials': 'L', 'LastName': 'Jurgauskiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: laimute.jurgauskiene@santa.lt.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Norkuniene', 'Affiliation': 'Department of Mathematical Statistics, Faculty of Fundamental Sciences, Vilnius Gediminas Technical University, Vilnius, Lithuania. Electronic address: j.norkuniene1@gmail.com.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Serpytis', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: mindaugas.serpytis@santa.lt.'}, {'ForeName': 'Jurate', 'Initials': 'J', 'LastName': 'Sipylaite', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: jurate.sipylaite@santa.lt.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.009'] 2212,32513881,"Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial.","INTRODUCTION Children of incarcerated parents comprise a greatly disadvantaged group in society and positive parenting constitutes an important factor for children's healthy development. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.This study aims to investigate the effects of the parenting programme currently offered in prisons in Sweden, For Our Children's Sake (FOCS), through a controlled trial with a parallel implementation process evaluation. METHODS AND ANALYSIS The effectiveness trial is carried out as a non-blinded controlled trial with a parallel investigation of the implementation process using mixed methods. Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents. Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent. The FOCS intervention is carried out in group format over 10 weeks. The primary outcome is closeness in parent-child relationship measured with the Child Parent Relationship Scale. Secondary outcomes comprise parent-child contact, parental criminal attitude and interest in other treatment programmes. Mediators comprise attitude to parenting, and self-efficacy. Outcome data are self-reported and collected over four time points: baseline (September to December 2019), mid and after intervention, and at 3 months follow-up. Implementation data is collected during and after intervention. Intervention fidelity is monitored through audio recordings, dose is registered per participant, reach comprise included versus eligible number of parents and acceptability is investigated through semi-structured interviews. Factors influencing implementation will be investigated using a questionnaire. ETHICS AND DISSEMINATION Ethical permission has been obtained by the Swedish Ethical Review Authority 2019-04227. Findings will be published in peer-reviewed journals, presented at scientific conferences and presented to participants in writing. TRIAL REGISTRATION NUMBER NCT04101799; Pre-results.",2020,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[""prisons in Sweden, For Our Children's Sake (FOCS"", 'Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents', 'Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent', ""children's healthy development""]","['FOCS intervention', 'parenting programme']","['parent-child contact, parental criminal attitude and interest in other treatment programmes', 'closeness in parent-child relationship measured with the Child Parent Relationship Scale']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.235758,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[{'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden asa.norman@ki.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Enebrink', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034834'] 2213,32513895,Does delaying discharge from intensive care until after tracheostomy removal affect 30-day mortality? Propensity score matched cohort study.,"OBJECTIVE To investigate the short-term mortality effect of discharge from an intensive care unit (ICU) with a tracheostomy in place in comparison to delaying discharge until after tracheostomy removal. DESIGN A propensity score matched cohort study using data from the TracMan study. SETTING Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated). PARTICIPANTS 622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008. 144 patients left ICU with a tracheostomy. 999 days of observation from 294 patients were included in the control pool. INTERVENTIONS We matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place. Propensity models were developed according to discharge destination, accounting for likely confounding factors. PRIMARY OUTCOME MEASURE The primary outcome was 30-day mortality from the matching day. For the 'discharged with a tracheostomy' group, this was death within 30 days after the discharge day. For the 'remained in ICU' group, this was death within 30 days after the matched day. RESULTS 22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23). CONCLUSION Keeping patients on an ICU to provide tracheostomy care was not found to affect mortality. Tracheostomy presence may indicate a higher risk of mortality due to underlying diseases and conditions rather than posing a risk in itself.The TracMan trial was registered on the ISRCTN database (ISRCTN28588190).",2020,"RESULTS 22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23). ","['Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated', 'matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place', '294 patients were included in the control pool', '622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008', '144 patients left ICU with a tracheostomy']",['intensive care unit (ICU'],['30-day mortality'],"[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",294.0,0.23793,"RESULTS 22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23). ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vollam', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK sarah.vollam@ndcn.ox.ac.uk.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Watkinson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037762'] 2214,32513936,Investigating resting brain perfusion abnormalities and disease target-engagement by intranasal oxytocin in women with bulimia nervosa and binge-eating disorder and healthy controls.,"Advances in the treatment of bulimia nervosa and binge-eating disorder (BN/BED) have been marred by our limited understanding of the underpinning neurobiology. Here we measured regional cerebral blood flow (rCBF) to map resting perfusion abnormalities in women with BN/BED compared with healthy controls and investigate whether intranasal oxytocin (OT), proposed as a potential treatment, can restore perfusion in disorder-related brain circuits. Twenty-four women with BN/BED and 23 healthy women participated in a randomized, double-blind, crossover, placebo-controlled study. We used arterial spin labelling MRI to measure rCBF and the effects of an acute dose of intranasal OT (40 IU) or placebo over 18-26 min post dosing, as we have previously shown robust OT-induced changes in resting rCBF in men in a similar time-window (15-36 min post dosing). We tested for effects of treatment, diagnosis and their interaction on extracted rCBF values in anatomical regions-of-interest previously implicated in BN/BED by other neuroimaging modalities, and conducted exploratory whole-brain analyses to investigate previously unidentified brain regions. We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally. Hyperperfusion in these areas specifically correlated with eating symptoms severity in patients. Our data did not support a normalizing effect of intranasal OT on perfusion abnormalities in these patients, at least for the specific dose (40 IU) and post-dosing interval (18-26 min) examined. Our findings enhance our understanding of resting brain abnormalities in BN/BED and identify resting rCBF as a non-invasive potential biomarker for disease-related changes and treatment monitoring. They also highlight the need for a comprehensive investigation of intranasal OT pharmacodynamics in women before we can fully ascertain its therapeutic value in disorders affecting predominantly this gender, such as BN/BED.",2020,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","['Twenty-four women with BN/BED and 23 healthy women', 'women with BN/BED compared with healthy controls', 'bulimia nervosa and binge-eating disorder (BN/BED', 'women with bulimia nervosa and binge-eating disorder and healthy controls']","['intranasal OT', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']","['perfusion abnormalities', 'medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally', 'resting rCBF', 'regional cerebral blood flow (rCBF', 'eating symptoms severity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0018427', 'cui_str': 'Structure of cingulate gyrus'}, {'cui': 'C0228261', 'cui_str': 'Structure of long insular gyrus'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",24.0,0.231848,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rodan', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00871-w'] 2215,32514007,Prenatal consults with illustrated literature (PnCIL): a RCT studying visual aids during prenatal consults.,"OBJECTIVE We hypothesize that addition of illustrated handouts during prenatal consultations decreases maternal anxiety and improves maternal knowledge. STUDY DESIGN Inpatient gravid women at 25 0/7-34 6/7 weeks gestation were randomized to Standard or Illustrated consults, verbal consults supplemented with a visual handout. Post consult surveys were administered assessing maternal anxiety and knowledge acquisition. RESULT We enrolled 82 women; 54 to Standard Consult, 28 to Illustrated Consult. Consult duration was the same across arms. Anxiety and knowledge were not impacted by the intervention overall. We found higher mean knowledge by 17% for consults ≥31 min (P = 0.006; 95% CI 0.67-3.82), and 13% in primigravids (P = 0.032; 95% CI 0.15-3.21) in the intervention arm. CONCLUSIONS Using illustrated handouts is feasible and does not increase duration of prenatal consults. It may improve knowledge acquisition in long consults and in primigravida women, although it does not impact anxiety and knowledge overall.",2020,"We found higher mean knowledge by 17% for consults ≥31 min (P = 0.006; 95% CI 0.67-3.82), and 13% in primigravids (P = 0.032; 95% CI 0.15-3.21) in the intervention arm. ","['Inpatient gravid women at 25 0/7-34 6/7 weeks gestation', 'We enrolled 82 women; 54 to Standard Consult, 28 to Illustrated Consult']","['illustrated literature (PnCIL', 'Standard or Illustrated consults, verbal consults supplemented with a visual handout']","['Anxiety and knowledge', 'knowledge acquisition', 'maternal anxiety and knowledge acquisition', 'maternal\xa0anxiety and improves maternal knowledge', 'mean knowledge']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",82.0,0.0820501,"We found higher mean knowledge by 17% for consults ≥31 min (P = 0.006; 95% CI 0.67-3.82), and 13% in primigravids (P = 0.032; 95% CI 0.15-3.21) in the intervention arm. ","[{'ForeName': 'Namrita J', 'Initials': 'NJ', 'LastName': 'Odackal', 'Affiliation': 'Division of Neonatology, St. Vincent Hospital, Billings, MT, USA. namrita.j.odackal@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conaway', 'Affiliation': 'Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Cha', 'Affiliation': 'School of Arts and Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swanson', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Virginia, Charlottesville, VA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0709-y'] 2216,32514040,A registered replication study on oxytocin and trust.,"In an influential paper, Kosfeld et al. (2005) showed that intranasal administration of oxytocin (OT) increases the transfers made by investors in the trust game-suggesting that OT increases trust in strangers. Subsequent studies investigating the role of OT in the trust game found inconclusive effects on the trusting behaviour of investors but these studies deviated from the Kosfeld et al. study in an important way-they did not implement minimal social contact (MSC) between the investors and the trustees in the trust game. Here, we performed a large double-blind and placebo-controlled replication study of the effects of OT on trusting behaviour that yields a power of more than 95% and implements an MSC condition as well as a no-social-contact (NoC) condition. We find no effect of OT on trusting behaviour in the MSC condition. Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",2020,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.",[],"['OT', 'oxytocin', 'oxytocin (OT', 'placebo']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0573493,"Exploratory post hoc analyses suggest that OT may increase trust in individuals with a low disposition to trust in the NoC condition, but this finding requires confirmation in future research.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Declerck', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boone', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Pauwels', 'Affiliation': 'Faculty of Business and Economics, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Chair in Empirical Economics and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich, Zurich, Switzerland. ernst.fehr@econ.uzh.ch.'}]",Nature human behaviour,['10.1038/s41562-020-0878-x'] 2217,32514060,"Commentary on ""A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial"".",,2020,,[],['international scientific SCI exercise guidelines'],['SCI chronic pain'],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.242921,,"[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Mulroy', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, USA. smulroy@dhs.lacounty.gov.'}]",Spinal cord,['10.1038/s41393-020-0494-7'] 2218,32509320,Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study.,"Background A stroke is a sudden, life-altering event with potentially devastating consequences for survivors and their loved ones. Despite advances in endovascular and neurocritical care approaches to stroke treatment and recovery, there remains a considerable unmet need for interventions targeting the emotional impact of stroke for both patients and their informal caregivers. This is important because untreated emotional distress becomes chronic and negatively impacts quality of life in both patients and caregivers. Our team previously used mixed methods to iteratively develop a six-session modular dyadic intervention to prevent chronic emotional distress in patients with stroke and their informal caregivers called ""Recovering Together"" (RT) using feedback from dyads and the medical team. The aim of the current study is to test the feasibility of recruitment, acceptability of screening and randomization methods, acceptability of RT, satisfaction with RT, feasibility of the assessment process at all time points, and acceptability of outcome measures. Secondarily, we aimed to explore within-treatment effect sizes and change in clinically significant symptoms of depression, anxiety, and post-traumatic stress (PTS). The larger goal was to strengthen methodological rigor before a subsequent efficacy trial. Methods We conducted a feasibility randomized controlled trial to evaluate the RT intervention relative to minimally enhanced usual care (MEUC) in stroke patients admitted to a Neurosciences Intensive Care Unit (Neuro-ICU). Dyads were enrolled within 1 week of hospitalization if they met specific eligibility criteria. Assessments were done via paper and pencil at baseline, and electronically via REDCap or over the phone at post-intervention (approximately 6 weeks after baseline), and 3 months later. Assessments included demographics, resiliency intervention targets (mindfulness, coping, self-efficacy, and interpersonal bond), and emotional distress (depression, anxiety, and PTS). Primary outcomes were feasibility and acceptability markers. Secondary outcomes were depression, anxiety, PTS, mindfulness, coping, self-efficacy, and interpersonal bond. Results We consented 20 dyads, enrolled 17, and retained 16. Although many patients were missed before we could approach them, very few declined to participate or dropped out once study staff made initial contact. Feasibility of enrollment (87% of eligible dyads enrolled), acceptability of screening, and randomization (all RT dyads retained after randomization) were excellent. Program satisfaction (RT post-test M = 11.33/12 for patients M = 12/12 for caregivers), and adherence to treatment sessions (six of seven RT dyads attending 4/6 sessions) were high. There were no technical difficulties that affected the delivery of the intervention. There was minimal missing data. For both patients and caregivers, participation in RT was generally associated with clinically significant improvement in emotional distress symptoms from baseline to post-test. Participation in MEUC was associated with clinically significant worsening in emotional distress. Although some of the improvement in emotional distress symptoms decreased in the RT group between post-test to 3 months, these changes were not clinically significant. RT was also associated with substantial decrease in frequency of individuals who met criteria for clinically significant symptoms, while the opposite was true for MEUC. There were many lessons that informed current and future research. Conclusions This study provided evidence of feasibility and signal of improvement in RT, as well as necessary methodological changes to increase recruitment efficiency before the future hybrid efficacy-effectiveness trial. Trial registration NCT02797509.",2020,"For both patients and caregivers, participation in RT was generally associated with clinically significant improvement in emotional distress symptoms from baseline to post-test.","['stroke patients admitted to a Neurosciences Intensive Care Unit (Neuro-ICU', 'We consented 20 dyads, enrolled 17, and retained 16', 'dyads of stroke patients and their caregivers at risk for chronic emotional distress', 'patients with stroke and their informal caregivers called ""Recovering Together"" (RT) using feedback from dyads and the medical team']",['RT intervention relative to minimally enhanced usual care (MEUC'],"['chronic emotional distress', 'feasibility and acceptability markers', 'depression, anxiety, and post-traumatic stress (PTS', 'emotional distress', 'emotional distress symptoms', 'depression, anxiety, PTS, mindfulness, coping, self-efficacy, and interpersonal bond', 'demographics, resiliency intervention targets (mindfulness, coping, self-efficacy, and interpersonal bond), and emotional distress (depression, anxiety, and PTS']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.162205,"For both patients and caregivers, participation in RT was generally associated with clinically significant improvement in emotional distress symptoms from baseline to post-test.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA 02114 USA.'}, {'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA 02114 USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA 02114 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McCurley', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, 100 Cambridge St, Suite 1600, Boston, MA 02114 USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA 02114 USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosand', 'Affiliation': 'Henry and Allison McCance Center for Brain Health, Department of Neurology, Massachusetts General Hospital, Boston, MA USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Suite 100, Boston, MA 02114 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00615-z'] 2219,32509321,Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial.,"Background Complications after major surgery are a significant cause of morbidity and mortality. Neck dissection is one of the most commonly performed major operations in Head and Neck Surgical Oncology. Significant surgical complications occur in approximately 10-20% of all patients, increasing to 40% in patients who have had previous treatment to the area or have multiple co-morbidities and/or polypharmacy.Current evidence suggests that fibrin sealants (FS) may have potential clinical advantages in Head and Neck Surgery through the reduction of complications, volume of wound drainage and retention time of the drains. However, a paucity of high-quality trial-based evidence means that a surgical trial to determine the effectiveness of FS in reducing the rate and severity of complications in patients undergoing lateral neck dissection is warranted. The DEFeND randomised external pilot trial will address critical questions on how well key components of the proposed study design work together as well as the feasibility of a future phase III trial. Methods The study design that is being piloted is that of a two-arm, parallel group, superiority trial with block randomisation in a 1:1 allocation ratio. The interventional arm will constitute the application of FS (Artiss, Baxter Healthcare Ltd.) to the surgical wound following completion of a neck dissection procedure, in addition to standard of care (SOC). The control arm will constitute SOC alone. Eligible patients will include patients who require a lateral neck dissection with a minimum of three cervical nodal levels. Patients who require bilateral neck procedures or undergoing immediate reconstruction with free or regional flaps will be excluded. The outcomes being assessed will be recruitment rate, screened to randomisation rate, fidelity of blinding process using blinding indices, number of missing or incomplete data entries, number of protocol deviations and number of losses to follow-up. Suitability of the outcome measures proposed for the future phase III trial will also be assessed. Discussion The anticipated challenges for this study will be recruitment, complexity of the intervention and adherence to the protocol. The outcomes will inform the design, feasibility and conduct of a future phase III surgical trial. Trial registration First participant randomised: November 06, 2018; UKCRN Portfolio ID: 37896; ISRCTN99181100.",2020,"The outcomes being assessed will be recruitment rate, screened to randomisation rate, fidelity of blinding process using blinding indices, number of missing or incomplete data entries, number of protocol deviations and number of losses to follow-up.","['Patients who require bilateral neck procedures or undergoing immediate reconstruction with free or regional flaps will be excluded', 'Eligible patients will include patients who require a lateral neck dissection with a minimum of three cervical nodal levels', 'patients undergoing lateral neck dissection', 'patients undergoing lateral neck dissection (DEFeND']","['fibrin sealants', 'fibrin sealants (FS']","['morbidity and mortality', 'randomisation rate, fidelity of blinding process using blinding indices, number of missing or incomplete data entries, number of protocol deviations and number of losses to follow-up', 'rate and severity of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0406025', 'cui_str': 'Procedure on neck'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.239999,"The outcomes being assessed will be recruitment rate, screened to randomisation rate, fidelity of blinding process using blinding indices, number of missing or incomplete data entries, number of protocol deviations and number of losses to follow-up.","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Bajwa', 'Affiliation': 'Liverpool Head and Neck Centre, University of Liverpool and Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Carruthers', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hanson', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Braithwaite', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catrin Tudur', 'Initials': 'CT', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Liverpool Head and Neck Centre, University of Liverpool and Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Schache', 'Affiliation': 'Liverpool Head and Neck Centre, University of Liverpool and Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00618-w'] 2220,32509322,A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial.,"Background In the NICU, interventions intended to enhance maternal sensitivity are indicated in order to optimize preterm infant development and long-term mother-infant attachment. A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit). The primary objective of this study is to evaluate the feasibility and acceptability of (i) the study design; and (ii) the experimental GP_Posit nursing intervention during NICU hospitalization. The secondary objective is to estimate the preliminary effects of GP_Posit on maternal and preterm infant outcomes. Methods A pilot parallel-group randomized clinical trial (RCT) was designed where mother-preterm infant dyads are being recruited and randomized to a control group (usual care) or experimental group (GP_Posit intervention). Data collection includes feasibility and acceptability data as well as preliminary effects on maternal sensitivity and infant neurodevelopment. Ethical approval from the University Hospital ethical board was obtained in January 2018 (2017-1540). Discussion Data collection for this pilot study is expected to end in 2020. Results of this pilot study will inform about the feasibility and acceptability of the study design and GP_Posit intervention, a nursing intervention having the potential to favor maternal sensitivity and infant neurodevelopment in the NICU and guide the elaboration of a large-scale RCT. Trial registration clinicaltrial.gov, NCT03677752. Registered 19 September 2018.",2020,A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit).,"['mothers of preterm infants', 'mother-preterm infant dyads', 'January 2018 (2017-1540']","['GP_Posit intervention', 'control group (usual care) or experimental group (GP_Posit intervention', 'GP_Posit', 'NICU', 'GP_Posit nursing intervention', 'guided participation nursing intervention to theraupeutic positioning and care (GP_Posit']",['maternal sensitivity and infant neurodevelopment'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.112264,A novel nursing intervention was developed following a theory-oriented methodology and is based upon the guided participation theory for mothers to participate in their preterm infant's therapeutic POSITioning and care (GP_Posit).,"[{'ForeName': 'Andréane', 'Initials': 'A', 'LastName': 'Lavallée', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Aita', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Quebec Network on Nursing Intervention Research (RRISIQ), Quebec, Canada.'}, {'ForeName': 'Thuy Mai', 'Initials': 'TM', 'LastName': 'Luu', 'Affiliation': 'CHU Sainte-Justine Research Centre, Montréal, Canada.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00601-5'] 2221,32509340,Comparison between the Express Implant and Transscleral Diode Laser in Neovascular Glaucoma.,"Purpose To compare the outcomes of Ex-PRESS glaucoma filtration device and transscleral cyclophotocoagulation (TSCP) in the management of neovascular glaucoma (NVG). Patients and Methods . A total of 30 eyes (12 express shunts and 18 TSCP) of 28 patients were included. The eyes had NVG with intraocular pressure (IOP) more than 21 mmHg of the maximally tolerated medication treatment after previous panretinal photocoagulation and antivascular endothelial growth factor (anti-VEGF) injection, with no previous history of a cyclodestruction procedure or glaucoma surgery, were randomized either for Ex-PRESS glaucoma filtration device or TSCP. The patients were followed up weekly for the first month and then monthly for 12 months as regard to the IOP, number of topical antiglaucoma drugs required, visual outcome, and postoperative complications. Results IOP was successfully controlled with both techniques in 83.3% of the eyes. Both techniques had fewer complications and required fewer subsequent procedures. Conclusion Both the Ex-PRESS glaucoma filtration device and TSCP might constitute safe and alternative therapeutic tools for patients with NVG. However, TSCP is an easier procedure, less time consuming, and does not require a learning curve.",2020,"Both techniques had fewer complications and required fewer subsequent procedures. ","['patients with NVG', 'A total of 30 eyes (12 express shunts and 18 TSCP) of 28 patients were included', 'Neovascular Glaucoma', 'neovascular glaucoma (NVG']","['NVG with intraocular pressure (IOP', 'Ex-PRESS glaucoma filtration device and transscleral cyclophotocoagulation (TSCP', 'panretinal photocoagulation and antivascular endothelial growth factor (anti-VEGF) injection', 'TSCP', 'Transscleral Diode Laser']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017609', 'cui_str': 'Neovascular glaucoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0017609', 'cui_str': 'Neovascular glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C0079280', 'cui_str': 'Endothelial Growth Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]",[],30.0,0.0452651,"Both techniques had fewer complications and required fewer subsequent procedures. ","[{'ForeName': 'Faried Mohammed', 'Initials': 'FM', 'LastName': 'Wagdy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt.'}, {'ForeName': 'Adel Galal', 'Initials': 'AG', 'LastName': 'Zaky', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt.'}]",Journal of ophthalmology,['10.1155/2020/3781249'] 2222,32509351,Immediate Effect on Ground Reaction Forces Induced by Step Training Based on Discrete Skill during Gait in Poststroke Individuals: A Pilot Study.,"Methods Twenty-two community-dwelling patients with chronic hemiplegia participated in this study. Eight participants performed only discrete-skill step training during the loading response phase, focusing on paretic hip extension movement (LR group). Another eight performed only discrete-skill step training during the preswing phase, focusing on paretic swing movement (PSw group). The remaining six were trained using both training methods, with at least 6 months in each group to washout the influence of previous training. Therefore, the final number of participants in each group was 14. The braking and propulsive forces of GRFs were measured during gait before and after 30 repetitions of the discrete-skill step training. Results Although both groups showed a significant increase in stride length, walking speed was increased only in the LR group. The PSw group showed an increase in braking forces of both sides without any change in propulsion. In the LR group, paretic braking impulse did not change, while nonparetic propulsion increased. Conclusion The discrete-skill step training during loading response phase induced an increase in nonparetic propulsion, resulting in increased walking speed. This study provides a clear understanding of immediate effects of the discrete-skill step training in patients with chronic stroke and helps improve interventions in long-term rehabilitation.",2020,The PSw group showed an increase in braking forces of both sides without any change in propulsion.,"['Methods\n\n\nTwenty-two community-dwelling patients with chronic hemiplegia participated in this study', 'Poststroke Individuals', 'patients with chronic stroke']","['Ground Reaction Forces Induced by Step Training', 'discrete-skill step training']","['stride length, walking speed', 'braking forces', 'nonparetic propulsion, resulting in increased walking speed', 'nonparetic propulsion increased', 'paretic braking impulse']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}]",8.0,0.0174273,The PSw group showed an increase in braking forces of both sides without any change in propulsion.,"[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Wakida', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Science, Gunma Paz University, Gunma, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Department of Rehabilitation, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Kimitaka', 'Initials': 'K', 'LastName': 'Hase', 'Affiliation': 'Department of Rehabilitation, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Shigehito', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Rehabilitation research and practice,['10.1155/2020/2397374'] 2223,32509383,Predicting long-term multicategory cause of death in patients with prostate cancer: random forest versus multinomial model.,"The majority of patients with prostate cancer die of non-cancer causes of death (COD). It is thus important to accurately predict multi-category COD in these patients. Random forest (RF), a popular machine learning model, has been shown useful for predicting binary cancer-specific deaths. However, its accuracy for predicting multi-category COD in cancer patients is unclear. We included patients in Surveillance, Epidemiology, and End Results-18 cancer registry-program with prostate cancer diagnosed in 2004 (followed-up through 2016). They were randomly divided into training and testing sets with equal sizes. We evaluated prediction accuracies of RF and conventional statistical/multinomial models for 6-category COD by data-encoding types using the 2-fold cross-validation approach. Among 49,864 prostate cancer patients, 29,611 (59.4%) were alive at the end of follow-up, and 5,448 (10.9%) died of cardiovascular disease, 4,607 (9.2%) of prostate cancer, 3,681 (7.4%) of non-prostate cancer, 717 (1.4%) of infection, and 5,800 (11.6%) of other causes. We predicted 6-category COD among these patients with a mean accuracy of 59.1% (n=240, 95% CI, 58.7%-59.4%) in RF models with one-hot encoding, and 50.4% (95% CI, 49.7%-51.0%) in multinomial models. Tumor characteristics, prostate-specific antigen level, and diagnosis confirmation-method were important in RF and multinomial models. In RF models, no statistical differences were found between the accuracies of training versus cross-validation phases, and those of categorical versus one-hot encoding. We here report that RF models can outperform multinomial logistic models (absolute accuracy-difference, 8.7%) in predicting long-term 6-category COD among prostate cancer patients, while pathology diagnosis itself and tumor pathology remain important factors.",2020,"COD among these patients with a mean accuracy of 59.1% (n=240, 95% CI, 58.7%-59.4%) in RF models with one-hot encoding, and 50.4% (95% CI, 49.7%-51.0%) in multinomial models.","['patients in Surveillance, Epidemiology, and End Results-18 cancer registry-program with prostate cancer diagnosed in 2004 (followed-up through 2016', 'patients with prostate cancer', 'cancer patients', '49,864 prostate cancer patients', 'patients with prostate cancer die of non-cancer causes of death (COD']",[],['died of cardiovascular disease'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",[],"[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",49864.0,0.0242271,"COD among these patients with a mean accuracy of 59.1% (n=240, 95% CI, 58.7%-59.4%) in RF models with one-hot encoding, and 50.4% (95% CI, 49.7%-51.0%) in multinomial models.","[{'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Jishuitan Hospital, The Fourth Medical College of Peking University Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'School of Electrical and Electronic Engineering, Shanghai Institute of Technology Shanghai, China.'}, {'ForeName': 'Fuqing', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Department of Urology, Wuhan Union Hospital of Tongji Medical Collage, Huazhong University of Science and Technology Wuhan, China.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Shanahan', 'Affiliation': 'Department of Medicine, Princeton Medical Center Plainsboro, NJ, USA.'}, {'ForeName': 'Wei Vivian', 'Initials': 'WV', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health Piscataway, NJ, USA.'}, {'ForeName': 'Lanjing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, Princeton Medical Center Plainsboro, NJ, USA.'}]",American journal of cancer research,[] 2224,32509392,"Preventive effect of celecoxib in sorafenib-related hand-foot syndrome in hepatocellular carcinoma patients, a single-center, open-label, randomized, controlled clinical phase III trial.","Skin toxicity, especially hand-foot syndrome (HFS), is one of the most common sorafenib-induced adverse events (AEs) in hepatocellular carcinoma (HCC) patients, leading to treatment interruption and failure. Mucocutaneous inflammation may cause HFS; therefore, we investigated whether celecoxib can alleviate HFS, improve patients' quality of life and increase survival when administered in conjunction with active therapy. Our randomized, open-label study prospectively enrolled 116 advanced HCC patients receiving sorafenib as targeted therapy from July 2015 to July 2016. All patients were randomly assigned (1:1) via a computer-generated sequence to receive sorafenib with or without celecoxib. Sorafenib-related AEs were recorded, Survival was compared between the two groups. Compared to the Sorafenib group, the SoraCele group had lower incidence rates of ≥ grade 2 and grade 3 HFS (63.8% vs 29.3%, P < 0.001; 19.0% vs 3.4%, P = 0.008, respectively), hair loss, rash and abdominal pain. Kaplan-Meier analysis revealed a lower risk of ≥ grade 2 HFS (HR, 0.384; P = 0.002) and a lower dose reduction/interruption rate (46.6% to 15.5%, P < 0.001) in the SoraCele group. Cox proportional hazards regression analysis demonstrated that celecoxib was the only independent predictive factor of developing ≥ grade 2 HFS (HR, 0.414; P = 0.004). Longer progression-free survival (PFS) was also observed in the SoraCele group ( P = 0.039), although overall survival was not prolonged ( P = 0.305). These results suggest that sorafenib + Celecoxib administration alleviated sorafenib-related skin toxicity. Longer PFS was achieved in clinical practice, although overall survival was not prolonged (ClinicalTrials.gov: NCT02961998).",2020,"Longer progression-free survival (PFS) was also observed in the SoraCele group ( P = 0.039), although overall survival was not prolonged (","['hepatocellular carcinoma patients', 'hepatocellular carcinoma (HCC) patients', '116 advanced HCC patients receiving sorafenib as targeted therapy from July 2015 to July 2016']","['sorafenib with or without celecoxib', 'Sorafenib', 'celecoxib', 'sorafenib + Celecoxib']","['Longer progression-free survival (PFS', 'Longer PFS', 'incidence rates of ≥ grade 2 and grade 3 HFS', 'overall survival', 'sorafenib-related skin toxicity', 'Survival', 'interruption rate', 'Skin toxicity', 'hair loss, rash and abdominal pain']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",116.0,0.227487,"Longer progression-free survival (PFS) was also observed in the SoraCele group ( P = 0.039), although overall survival was not prolonged (","[{'ForeName': 'Jian-Cong', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Jun-Cheng', 'Initials': 'JC', 'LastName': 'Wang', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Yang-Xun', 'Initials': 'YX', 'LastName': 'Pan', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Min-Jiang', 'Initials': 'MJ', 'LastName': 'Yi', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Jin-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Yi-Zhen', 'Initials': 'YZ', 'LastName': 'Fu', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Min-Shan', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}, {'ForeName': 'Rong-Xin', 'Initials': 'RX', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Guangzhou, P. R. China.'}, {'ForeName': 'Zhong-Guo', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Department of Liver Surgery, Sun Yat-sen University Cancer Center Guangzhou, P. R. China.'}]",American journal of cancer research,[] 2225,32171767,Endothelial Safety and Efficacy of Ex Vivo Collagen Cross-linking of Human Corneal Transplants.,"PURPOSE To assess endothelial safety and efficacy of ex vivo corneal collagen cross-linking (CXL) in human corneal transplants stored in 2 different culture media. DESIGN Fellow-eye controlled laboratory study of ex vivo human donor corneas. METHODS Three sets of paired human donor corneas, 5 pairs each, were stored in organ culture medium before deswelling either at 31 C or at room temperature. One eye of each pair was cross-linked by 0.1% riboflavin in hydroxylpropyl methylcellulose (HPMC) instillation for 10 minutes followed by 10 minutes of ultraviolet-A (9 mW/cm 2 ) irradiation while contralateral eyes served as controls. In Set 1, endothelial cell densities were determined. In Set 2, paired samples were assigned to the 2 deswelling media and CXL efficacy was assessed comparing to untreated controls using collagenase-A-assisted enzymatic digestion. In Set 3, biomechanical testing was performed in the eye pairs (treated vs control) by stress/strain measurements. RESULTS There was no difference in endothelial cell counts between CXL samples and controls (P = .21). No statistically significant difference in digestion dynamics was found between tissues stored in the 2 different culture media. Complete enzymatic digestion was slowed down by 3 hours in the cross-linked samples (P = .036). Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). CONCLUSIONS Ex vivo CXL of human donor tissue is an effective and safe procedure with no difference regarding efficacy between 2 commercially available deswelling media. Biochemical and biomechanical resistance were significantly increased after CXL. Patients requiring keratoplasty owing to corneal melting might benefit from the strengthening effect of preoperative CXL of donor tissue.",2020,"Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). ","['Human Corneal Transplants', 'Three sets of paired human donor corneas, 5 pairs each, were stored in organ culture medium before deswelling either at 31 C or at room temperature', 'Fellow-eye controlled laboratory study of ex\xa0vivo human donor corneas', 'human corneal transplants stored in 2 different culture media']","['ex\xa0vivo corneal collagen cross-linking (CXL', 'riboflavin']","['Endothelial Safety and Efficacy', 'Stress needed for a 12% strain', 'digestion dynamics', 'Complete enzymatic digestion', 'Biochemical and biomechanical resistance', 'CXL efficacy', 'endothelial cell densities', 'endothelial cell counts', 'endothelial safety and efficacy']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}]",,0.0228488,"Stress needed for a 12% strain was increased by 34% in the treatment group compared to control (P = .04). ","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lammer', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. Electronic address: jan.lammer@meduniwien.ac.at.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Laggner', 'Affiliation': 'Division of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Vienna Business Agency Project 2343727 ""APOSEC to Clinic"", Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Pircher', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Isaak', 'Initials': 'I', 'LastName': 'Fischinger', 'Affiliation': 'Department of Ophthalmology, Augentagesklinik Spreebogen Berlin, Berlin, Germany; Department of Ophthalmology, Johannes Kepler Universität, Kepler Universitätsklinikum Linz, Linz, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hofmann', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Schmidinger', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.024'] 2226,32509895,Effect of sexual health education on sexual function and resumption of sexual intercourse after childbirth in primiparous women.,"INTRODUCTION A large number of women experience sexual health problems during the postpartum period. This study aimed to evaluate the effect of sexual health education on sexual function and time of sexual intercourse resumption after childbirth in primiparous women in Southeast Iran. MATERIALS AND METHODS This randomized clinical trial was conducted on 94 primiparous women randomly divided into two groups of intervention and control. The intervention group was subjected to three training sessions 3-5, 10-14, and 30-45 days after childbirth (first session lasting 20 min and other sessions 60 min). On the other hand, the participants in the control group only received the routine postpartum training. The Female Sexual Function Index (FSFI) was completed by all participants before and 8 weeks after the intervention. Data were analyzed in SPSS software (version 22) using descriptive and inferential statistics, such as Chi-square test, independent t -test, and paired sample t -test. P < 0.05 was considered statistically significant. RESULTS The mean score of FSFI in the intervention group was increased from 12.70 ± 6.166 before the onset of the intervention to 17.36 ± 5.407 after 8 weeks ( P = 0.01). In the control group, the mean score of FSFI was decreased from 13.09 ± 4.306 to 12.29 ± 3.511 on the 8 th week postpartum ( P = 0.06). The mean times of sexual intercourse resumption in the intervention and control groups were 5.82 ± 0.17 and 5.81 ± 0.22 weeks, respectively, which were not significantly different between the two groups ( P = 0.879). CONCLUSION Sexual health education for women in the postpartum period could improve their sexual function after childbirth. However, it is recommended to use sexual health education programs in women during the postpartum period to promote female sexual function.",2020,"The mean times of sexual intercourse resumption in the intervention and control groups were 5.82 ± 0.17 and 5.81 ± 0.22 weeks, respectively, which were not significantly different between the two groups ( P = 0.879). ","['primiparous women in Southeast Iran', 'primiparous women', '94 primiparous women randomly divided into two groups of']","['sexual health education', 'Sexual health education', 'intervention and control', 'routine postpartum training']","['mean times of sexual intercourse resumption', 'Female Sexual Function Index (FSFI', 'sexual function', 'sexual function and resumption of sexual intercourse', 'sexual function and time of sexual intercourse resumption', 'mean score of FSFI']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0291692,"The mean times of sexual intercourse resumption in the intervention and control groups were 5.82 ± 0.17 and 5.81 ± 0.22 weeks, respectively, which were not significantly different between the two groups ( P = 0.879). ","[{'ForeName': 'Zahra Pahlavani', 'Initials': 'ZP', 'LastName': 'Sheikhi', 'Affiliation': 'Pregnancy Health Research Center, Zahedan University of Medical Science, Department of Counseling Midwifery, Nursing and Midwifery School, Zahedan University of Medical Science, Zahedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Pregnancy Health Research Center, Zahedan University of Medical Science, Department of Counseling Midwifery, Nursing and Midwifery School, Zahedan University of Medical Science, Zahedan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rigi', 'Affiliation': 'Student of Midwifery Counseling, School of Nursing and Midwifery Zahedan University of Medical Science, Zahedan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_591_19'] 2227,32509898,Effectiveness of a curriculum-based educational intervention on oral health behavior and dental caries experience among Indian schoolchildren.,"BACKGROUND The high incidence of dental diseases among Indian children can be attributed to low awareness regarding the oral health maintenance. The school health curriculum in India is deficient of an oral health component, and there are no organized oral health programs for schoolchildren existing at present. Therefore, the present study was conducted to assess the effectiveness of an oral health curriculum in improving the oral health behavior and dental caries experience in schoolchildren. METHODS A nonrandomized trial with pretest/posttest design was conducted among 600 schoolchildren. Two intervention arms were designed with one group receiving health education from a dental health professional and other from a school teacher. The oral health curriculum was customized for three sections of different age groups (lower primary [LP], upper primary [UP], high school [HS]) and implemented for a period of 1 year. Oral health behaviors were recorded using a Knowledge, Attitude and Practice (KAP) questionnaire and were evaluated at baseline, 6 months, and 1 year of the educational intervention. Dental caries experience was measured Pre and Post - intervention using deft and decayed, missing, and filled teeth indices. Descriptive statistics were calculated for continuous data, and the change in KAP scores and dental caries experience was analyzed using the repeated measures of ANOVA, independent t -tests, and paired t -tests. RESULTS There were significant improvements in KAP regarding oral health among Indian schoolchildren. Significant reductions in decayed primary teeth were observed in LP and UP schoolchildren post-intervention. However, there was no significant difference in primary outcome between the two intervention arms. CONCLUSIONS A curriculum-based health education intervention customized for different age groups was found to be effective in improving oral health behavior and dental caries experience among Indian schoolchildren.",2020,Significant reductions in decayed primary teeth were observed in LP and UP schoolchildren post-intervention.,"['schoolchildren', 'Indian schoolchildren', 'Indian children', '600 schoolchildren']","['curriculum-based educational intervention', 'one group receiving health education from a dental health professional and other from a school teacher', 'oral health curriculum']","['Oral health behaviors', 'oral health behavior and dental caries experience', 'Knowledge, Attitude and Practice (KAP) questionnaire', 'KAP regarding oral health', 'KAP scores and dental caries experience']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0227768,Significant reductions in decayed primary teeth were observed in LP and UP schoolchildren post-intervention.,"[{'ForeName': 'Vineetha', 'Initials': 'V', 'LastName': 'Karuveettil', 'Affiliation': 'Department of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'S Vijay', 'Initials': 'SV', 'LastName': 'Kumar', 'Affiliation': 'Department of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Chandrashekar', 'Initials': 'C', 'LastName': 'Janakiram', 'Affiliation': 'Department of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Department of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_619_19'] 2228,32509899,The effect of direct observation of procedural skills method on learning clinical skills of midwifery students of medical sciences.,"INTRODUCTION Clinical education is one of the most important parts of medical students' education, and it is a major part of the education of qualified and professional people. Therefore, this study was conducted to determine the effect of applying Direct Observation of Procedural Skills (DOPS) on midwifery students' clinical skills. MATERIALS AND METHODS This is a quasi-experimental, two-group study conducted as a pre- and post-study on midwifery students in 2017-2018. Cluster and randomized sampling method was used. The processors involved in this study were three main skills of vaginal examination, pelvic examination, and vaginal delivery. The DOPS method was used to assess the practical skills in the interventional group during three times the process at day, 1 day, and at least 1 week later; the usual logbook method was used in the control group. Two groups were evaluated at the end of the midwifery course by Comprehensive Final Midwifery checklist. The tools were checked for validity and reliability, and data were analyzed using descriptive and analytical statistics. RESULTS There was no statistically significant difference between the two groups in terms of important demographic variables such as age, grade, marital status, and initial assessment score ( P > 0.05). The mean of final scores in the normal delivery, vaginal examination, and pelvimetry was statistically significantly higher in the interventional group ( P < 0.001). On the other hand, the functional field of the students in the interventional group was statistically significantly improved in normal delivery and pelvimetry ( P < 0.05), and this difference was not significant in the vaginal examination. In addition, the mean scores of students before and after the DOPS method were statistically significantly different in every skill in Comprehensive Final Midwifery checklist ( P < 0/05). CONCLUSIONS The DOPS assessment methodology is not only a useful tool of clinical evaluation, but also an effective tool for clinical learning of students. For this purpose, it is suggested that educational members of midwifery take enough time to design DOPS method in the same process.",2020,"There was no statistically significant difference between the two groups in terms of important demographic variables such as age, grade, marital status, and initial assessment score ( P > 0.05).","['midwifery students of medical sciences', ""midwifery students' clinical skills"", 'midwifery students in 2017-2018']",['Direct Observation of Procedural Skills (DOPS'],"['vaginal examination, pelvic examination, and vaginal delivery', 'mean of final scores in the normal delivery, vaginal examination, and pelvimetry', 'normal delivery and pelvimetry', 'vaginal examination']","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0200048', 'cui_str': 'Examination of vagina'}, {'cui': 'C0200045', 'cui_str': 'Manual pelvic examination'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0030796', 'cui_str': 'Pelvimetry'}]",3.0,0.0215237,"There was no statistically significant difference between the two groups in terms of important demographic variables such as age, grade, marital status, and initial assessment score ( P > 0.05).","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Mohamadirizi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Mardanian', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Torabi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_672_19'] 2229,32509904,The effect of an educational intervention based on the theory of planned behavior on childbearing intentions in women: A quasi-experimental study.,"BACKGROUND Childbearing is an important biological and social event in the life of most women. It is a voluntary behavior that can be affected by many factors. Behavioral theories are a potential path way to study and influence childbearing behavior. The present study was conducted to determine the effect of an educational intervention based on the theory of planned behavior (TPB) on childbearing intentions in women presenting to premarital counseling centers in Tehran. MATERIALS AND METHODS This randomized controlled quasi-experimental study was conducted on 150 women aged 20-35 years presenting to premarital counseling centers. The participating women were randomly divided into an intervention ( n = 75) and a control ( n = 75) group using randomized sampling in Excel. The intervention group received two 90-min sessions of training. The effect of training was assessed 6 weeks after the intervention using the researcher-made questionnaire based on the components of the TPB. The questionnaires included subjects' demographic details, knowledge (11 items), attitude (13 items), subjective norms (10 items), perceived behavioral control (8 items), and behavioral intention (4 items). Data were analyzed by SPSS software (version 22) and independent t -test, Chi-square, Mann-Whitney U-test, and Wilcoxon test. P <0.05 was considered statistically significant. RESULTS There were significant differences between the intervention and control group after the intervention in the Mean ± SD scores of knowledge (6.73 ± 2.63 vs. 4.73 ± 2.85, P = 0.001), attitude (48.23 ± 7.19 vs. 40.13 ± 5.80, P = 0.001), perceived behavioral control (33.19 ± 5.28 vs. 23.59 ± 3.47, P = 0.001), and behavioral intention (13.84 ± 2.95 vs. 11.77 ± 2.12, P = 0.027). CONCLUSION The findings showed that an education based on the TPB increased women's childbearing intentions by affecting their knowledge, attitude, perceived behavioral control, and intention. It is therefore essential to implement better public policies, create a more conducive educational setting for women of different age groups, and build a social support system.",2020,"The findings showed that an education based on the TPB increased women's childbearing intentions by affecting their knowledge, attitude, perceived behavioral control, and intention.","['participating women', 'women presenting to premarital counseling centers in Tehran', 'childbearing intentions in women', '150 women aged 20-35 years presenting to premarital counseling centers']","['planned behavior (TPB', 'educational intervention', 'TPB']","[""subjects' demographic details, knowledge (11 items), attitude (13 items), subjective norms (10 items), perceived behavioral control (8 items), and behavioral intention (4 items"", 'behavioral intention', 'Mean ± SD scores of knowledge', 'perceived behavioral control']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199398', 'cui_str': 'Premarital counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0329153,"The findings showed that an education based on the TPB increased women's childbearing intentions by affecting their knowledge, attitude, perceived behavioral control, and intention.","[{'ForeName': 'Nourossadat', 'Initials': 'N', 'LastName': 'Kariman', 'Affiliation': 'Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyedeh Sara Baki', 'Initials': 'SSB', 'LastName': 'Hashemi', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Ghanbari', 'Affiliation': 'Department of Health Education and Promotion, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Pourhoseingholi', 'Affiliation': 'Department of Health System Research, Research Institute for Gastroenterology and Liver Disease, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Qazvin University of Medical Science, Qazvin, Iran.'}, {'ForeName': 'Farzaneh Rashidi', 'Initials': 'FR', 'LastName': 'Fakari', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_2_20'] 2230,32510046,Increased weight loading reduces body weight and body fat in obese subjects - A proof of concept randomized clinical trial.,"Background Recently we provided evidence for a leptin-independent homeostatic regulation, the gravitostat , of body weight in rodents. The aim of the present translational proof of concept study was to test the gravitostat hypothesis in humans. Methods We conducted a randomized controlled single center trial (ClinicalTrial.gov number, NCT03672903), to evaluate the efficacy of artificially increased weight loading on body weight in subjects with mild obesity (BMI 30-35 kg/m 2 ). Subjects were either treated with a heavy (=high load; 11% of body weight) or light (=low load; 1% of body weight) weight vest for eight hours per day for three weeks. The primary outcome was change in body weight. Secondary outcomes included change in body fat mass and fat-free mass as measured using bioelectrical impedance analysis. Findings In total 72 participants underwent randomization and 69 (36 high load and 33 low load) completed the study for the primary outcome. High load treatment resulted in a more pronounced relative body weight loss compared to low load treatment (mean difference -1.37%, 95% confidence interval (CI), -1.96 to -0.79; p  = 1.5 × 10 -5 ). High load treatment reduced fat mass (-4.04%, 95% CI, -6,53 to -1.55; p  = 1.9 × 10 -3 ) but not fat free mass (0.43%, 95% CI, -1.47 to 2.34; p  = 0.65) compared to low load treatment. Interpretation Increased weight loading reduces body weight and fat mass in obese subjects in a similar way as previously shown in obese rodents. These findings demonstrate that there is weight loading dependent homeostatic regulation of body weight, the gravitostat, also in humans. Funding Funded by Jane and Dan Olsson (JADO) Foundation, the Torsten Söderberg Foundation, The Knut and Alice Wallenberg's Foundation and the Novo Nordisk Foundation.",2020,"High load treatment reduced fat mass (-4.04%, 95% CI, -6,53 to -1.55; p  = 1.9 ","['In total 72 participants underwent randomization and 69 (36 high load and 33 low load) completed the study for the primary outcome', 'humans', 'subjects with mild obesity (BMI 30-35\xa0kg/m 2 ', 'obese subjects ', 'obese subjects']",['Funding\n\n\nFunded by Jane and Dan Olsson (JADO'],"['body weight', 'change in body weight', 'change in body fat mass and fat-free mass as measured using bioelectrical impedance analysis', 'fat mass', 'relative body weight loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",72.0,0.258745,"High load treatment reduced fat mass (-4.04%, 95% CI, -6,53 to -1.55; p  = 1.9 ","[{'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ohlsson', 'Affiliation': 'Centre for Bone and Arthritis Research, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Gidestrand', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bellman', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Larsson', 'Affiliation': 'Department of Food and Nutrition, and Sport Science, University of Gothenburg, Sweden.'}, {'ForeName': 'Vilborg', 'Initials': 'V', 'LastName': 'Palsdottir', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägg', 'Affiliation': 'Centre for Bone and Arthritis Research, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Jansson', 'Affiliation': 'Wallenberg Laboratory, Department of Molecular and Clinical Medicine, Institute of Medicine, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'John-Olov', 'Initials': 'JO', 'LastName': 'Jansson', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100338'] 2231,32510111,Effects of Health Risk Assessment and Counselling on Fruit and Vegetable Intake in Older People: A Pragmatic Randomised Controlled Trial.,"OBJECTIVES Interventions to increase fruit and vegetable intake among community-dwelling older people have shown mixed effects. We investigated whether an intervention based on an initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling has favourable effects on dietary intake among community-dwelling older people. DESIGN Randomised controlled trial comparing the intervention versus usual care. SETTING AND PARTICIPANTS Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups. INTERVENTION Participants received a computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption. MEASUREMENTS Fruit and vegetable intake at baseline and at 6-month follow-up. RESULTS At baseline, fruit and vegetable intake was below the recommended five portions per day in most study participants (85% in the intervention group, and 86% among controls, respectively). At six months, intake increased in the intervention group from a median of 3.8 to 4.6 portions per day, and decreased in the control group due to a seasonal effect from a median of 3.8 to 3.1 portions per day. At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls (median difference 1.4 portions per day, 95% confidence interval 1.1-1.7, p<0.001). CONCLUSION Personalised food-based dietary guidance, delivered as part of multidimensional preventive health counselling during geriatric clinic visits, results in relevant improvement of fruit and vegetable intake in community-dwelling older adults.",2020,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","['Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups', 'community-dwelling older adults', 'community-dwelling older people', 'Older People']","['Health Risk Assessment and Counselling on Fruit and Vegetable Intake', 'computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption', 'initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling']","['Fruit and vegetable intake', 'fruit and vegetable consumption', 'fruit and vegetable intake']","[{'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0373016,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Herghelegiu', 'Affiliation': 'Andreas Ernst Stuck, Department of Geriatrics, Inselspital, University Hospital Bern, and University of Bern, Bern, Switzerland, andreas.stuck@insel.ch.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moser', 'Affiliation': ''}, {'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Prada', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Nuta', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Stuck', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1373-9'] 2232,32510130,Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with polycystic ovary syndrome.,"STUDY QUESTION What is the role of the hypothalamic neuropeptide neurokinin B (NKB) and its interaction with kisspeptin on GnRH/LH secretion in women with polycystic ovary syndrome (PCOS)? SUMMARY ANSWER Administration of neurokinin 3 receptor antagonist (NK3Ra) for 7 days reduced LH and FSH secretion and LH pulse frequency in women with PCOS, whilst the stimulatory LH response to kisspeptin-10 was maintained. WHAT IS KNOWN ALREADY PCOS is characterized by abnormal GnRH/LH secretion. NKB and kisspeptin are master regulators of GnRH/LH secretion, but their role in PCOS is unclear. STUDY DESIGN, SIZE, DURATION The NK3Ra MLE4901, 40 mg orally twice a day, was administered to women with PCOS for 7 days (n = 8) (vs no treatment, n = 7). On the last day of NK3Ra administration or the equivalent day in those not treated, women were randomized to 7-h kisspeptin-10 (4 µg/kg/h i.v.) or vehicle infusion. This was repeated with the alternate infusion in a subsequent cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS Subjects were women with PCOS, studied in a Clinical Research Facility. Reproductive hormones were measured before and after NK3Ra administration. On the last day of NK3Ra administration (or the equivalent cycle day in untreated women), all women attended for an 8-h frequent blood sampling to allow analysis of the pulsatile LH secretion. MAIN RESULTS AND THE ROLE OF CHANCE NK3Ra reduced LH secretion (4.0 ± 0.4 vs 6.5 ± 0.8 IU/l, P < 0.05) and pulse frequency (0.5 ± 0.1 vs 0.8 ± 0.1 pulses/h, P < 0.05); FSH secretion was also reduced (2.0 ± 0.3 vs 2.5 ± 0.4 IU/l, P < 0.05). Without NK3Ra pre-treatment, kisspeptin-10 increased LH secretion (5.2 ± 0.5 to 7.8 ± 1.0 IU/L, P < 0.05), with a positive relationship to oestradiol concentrations (r2 = 0.59, P < 0.05). After NK3Ra administration, the LH response to kisspeptin-10 was preserved (vehicle 3.5 ± 0.3 vs 9.0 ± 2.2 IU/l with kisspeptin-10, P < 0.05), but the positive correlation with oestradiol concentrations was abolished (r2 = 0.07, ns. after NK3Ra). FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. LIMITATIONS, REASONS FOR CAUTION The study did not explore the dose relationship of the effect of NK3R antagonism. The impact of obesity or other aspects of the variability of the PCOS phenotype was not studied due to the small number of subjects. WIDER IMPLICATIONS OF THE FINDINGS These data demonstrate the interactive regulation of GnRH/LH secretion by NKB and kisspeptin in PCOS, and that the NKB system mediates aspects of oestrogenic feedback. STUDY FUNDING/COMPETING INTEREST(S) Wellcome Trust through Scottish Translational Medicine and Therapeutics Initiative (102419/Z/13/A) and MRC grants (G0701682 to R.P.M. and R.A.A.) and MR/N022556/1 to the MRC Centre for Reproductive Health. This work was performed within the Edinburgh Clinical Research Facility. J.T.G. has undertaken consultancy work for AstraZeneca and Takeda Pharmaceuticals and is an employee of Boehringer Ingelheim. R.P.M. has consulted for Ogeda and was CEO of Peptocrine. R.A.A. has undertaken consultancy work for Merck, Ferring, NeRRe Therapeutics and Sojournix Inc. J.D.V. and K.S. have nothing to disclose. TRIAL REGISTRATION NUMBER N/A.",2020,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","['women with polycystic ovary syndrome (PCOS', 'Subjects were women with PCOS, studied in a Clinical Research Facility', 'women with PCOS', 'women with polycystic ovary syndrome']","['hypothalamic neuropeptide neurokinin B (NKB', 'Kisspeptin and neurokinin B interactions', 'NK3Ra', 'NK3Ra MLE4901', 'kisspeptin']","['pulse frequency', 'LH response to kisspeptin-10', 'NK3Ra reduced LH secretion', 'FSH secretion', 'LH and FSH secretion and LH pulse frequency', 'oestradiol concentrations', 'Reproductive hormones', 'positive correlation with oestradiol concentrations', 'LH secretion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0027847', 'cui_str': 'Neurokinin beta'}, {'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1721258', 'cui_str': 'kisspeptin-10 protein, human'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.109421,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skorupskaite', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Warwick Medical School, Coventry CV4 7AL, UK.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Center for Translational Science Activities, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Millar', 'Affiliation': 'Centre for Neuroendocrinology and Mammal Research Institute, University of Pretoria, 0028 Pretoria, South Africa.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa104'] 2233,32510144,Blood Orange Juice Consumption Increases Flow-Mediated Dilation in Adults with Overweight and Obesity: A Randomized Controlled Trial.,"BACKGROUND Epidemiological studies have indicated an inverse association between citrus fruit consumption and cardiovascular disease (CVD) risk. There is, however, a paucity of data concerning effects of blood orange juice (BOJ) intake on endothelial function and cardiovascular risk biomarkers. OBJECTIVES We examined short-term effects of BOJ on endothelial function, blood pressure, lipid profile, and inflammatory markers in healthy participants of European origin who were overweight or obese. METHODS In a randomized, controlled, single-blind, crossover trial, 15 men and women (age: 28.7 ± 6.5 y; BMI: 28.3 ± 3.1 kg/m2) consumed BOJ or a sugar-matched control drink (CD) (200 mL twice daily) for 2 wk with a washout period of 1 wk. Endothelial function, measured as flow-mediated dilation (FMD) (primary outcome), and the secondary outcomes blood pressure, anthropometric measures, lipid profile, inflammatory markers, markers of vasodilation and vasoconstriction, and urinary flavanone metabolites were evaluated prior to and at the end of each treatment period following an overnight fast. Changes between treatments over time were assessed using repeated-measures ANOVA. RESULTS The results demonstrate a significant increase in FMD following BOJ consumption (pre: 8.15% ± 2.92%; post: 10.2% ± 3.31%; P = 0.002) compared with CD (pre: 8.11% ± 2.52%; post: 7.77% ± 2.43%; time × treatment interaction: P = 0.001). Concurrent significant increases in urinary hesperetin-3'-glucuronide and hesperetin-7-glucuronide were observed following BOJ supplementation only (time × treatment interaction: P ≤ 0.01). Baseline blood pressure, lipid profile, high-sensitivity C-reactive protein, and endothelin-1 were generally within healthy ranges and unaffected by the intervention. CONCLUSIONS A 2-wk consumption of BOJ exerted favorable effects on endothelial function in healthy women and men who were overweight or obese, which is likely mediated by the combined actions of anthocyanin and flavanone metabolites on mechanisms that contribute to enhancing NO bioavailability. This trial was registered at clinicaltrials.gov as NCT03611114.",2020,Concurrent significant increases in urinary hesperetin-3'-glucuronide and hesperetin-7-glucuronide were observed following BOJ supplementation only (time × treatment interaction: P ≤ 0.01).,"['15 men and women (age: 28.7\xa0±\xa06.5 y; BMI: 28.3\xa0±\xa03.1 kg/m2) consumed', 'healthy women and men who were overweight or obese', 'healthy participants of European origin who were overweight or obese', 'Adults with Overweight and Obesity']","['Blood Orange Juice Consumption Increases Flow-Mediated Dilation', 'BOJ supplementation', 'blood orange juice (BOJ) intake', 'BOJ', 'BOJ or a sugar-matched control drink (CD']","['endothelial function', 'Baseline blood pressure, lipid profile, high-sensitivity C-reactive protein, and endothelin-1', 'FMD following BOJ consumption', ""urinary hesperetin-3'-glucuronide and hesperetin-7-glucuronide"", 'endothelial function, blood pressure, lipid profile, and inflammatory markers', 'Endothelial function, measured as flow-mediated dilation (FMD) (primary outcome), and the secondary outcomes blood pressure, anthropometric measures, lipid profile, inflammatory markers, markers of vasodilation and vasoconstriction, and urinary flavanone metabolites']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0425355', 'cui_str': 'European origin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0062585', 'cui_str': 'hesperetin'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C0060425', 'cui_str': 'flavanone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",15.0,0.250322,Concurrent significant increases in urinary hesperetin-3'-glucuronide and hesperetin-7-glucuronide were observed following BOJ supplementation only (time × treatment interaction: P ≤ 0.01).,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, Beijing Technology and Business University, Beijing, China.'}, {'ForeName': 'Gemma K', 'Initials': 'GK', 'LastName': 'Lyall', 'Affiliation': 'School of Biomedical Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Martinez-Blazquez', 'Affiliation': 'Quality, Safety and Bioactivity of Plant Foods, Centre for Soil Science and Applied Biology-Spanish Council for Scientific Resarch (CEBAS-CSIC), Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Vallejo', 'Affiliation': 'Quality, Safety and Bioactivity of Plant Foods, Centre for Soil Science and Applied Biology-Spanish Council for Scientific Resarch (CEBAS-CSIC), Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'A Tomas-Barberan', 'Affiliation': 'Quality, Safety and Bioactivity of Plant Foods, Centre for Soil Science and Applied Biology-Spanish Council for Scientific Resarch (CEBAS-CSIC), Murcia, Spain.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Birch', 'Affiliation': 'School of Biomedical Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Boesch', 'Affiliation': 'School of Food Science and Nutrition, University of Leeds, Leeds, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa158'] 2234,32514369,The impact of summer programming on the obesogenic behaviors of children: behavioral outcomes from a quasi-experimental pilot trial.,"Background Children from low-income families experience accelerated BMI gain and learning loss during summer. Healthy Summer Learners (HSL) addresses accelerated BMI gain and academic learning loss during summer by providing academic- and health-focused programming. This manuscript reports the effects of HSL on underlying obesogenic behaviors (i.e., physical activity, screen time, sleep, diet) that lead to accelerated summer BMI gain, a necessary first step to informing a future randomized controlled trial of HSL. Methods In the summer of 2018 and 2019 using a quasi-experimental study design, 180 children (90 per summer, 7.9 years [SD = 1.0], 94% non-Hispanic Black, 40% male) at two schools (i.e., one per summer) who were struggling academically (25-75% on a standardized reading test) were provided a free, school-based 6-week health- and academic-focused summer program (i.e., HSL, n = 60), a 4- to 6-week academic-focused summer program (i.e., 21st Century Summer Learning program (21C), n = 60), or no summer program ( n = 60). Children wore the Fitbit Charge 2™ over a 10-week period during the summers (June-Aug) of 2018-2019. Differences within (within child days attend vs. not attend) and between (differences between groups attend vs. not attend) were evaluated using mixed effects linear regression. Results Regression estimates indicated that, on days attending, HSL children experienced a greater reduction in sedentary minutes (- 58.6 [95% CI = - 92.7, - 24.4]) and a greater increase in moderate-to-vigorous physical activity (MVPA) (36.2 [95% CI = 25.1, 47.3]) and steps (2799.2 [95% CI = 2114.2, 3484.2]) compared to 21C children. However, both HSL and 21C children were more active (i.e., greater MVPA, total steps) and less sedentary (i.e., less sedentary minutes and total screen time) and displayed better sleeping patterns (i.e., earlier and less variability in sleep onset and offset) on days they attended than children in the control. Conclusions HSL produced greater changes in physical activity than 21C. However, attendance at either HSL or 21C leads to more healthy obesogenic behaviors. Based on the behavioral data in this pilot study, a larger trial may be warranted. These results must be considered along with the pending primary outcomes (i.e., academics and BMI z -score) of the HSL pilot to determine if a full-scale trial is warranted. Trial registration NIH-NCT03321071. Registered 25 October 2017.",2020,"Results Regression estimates indicated that, on days attending, HSL children experienced a greater reduction in sedentary minutes (- 58.6 [95% CI = - 92.7, - 24.4]) and a greater increase in moderate-to-vigorous physical activity (MVPA) (36.2 [95% CI = 25.1, 47.3]) and steps (2799.2","['Healthy Summer Learners (HSL', '180 children (90 per summer, 7.9\u2009years [SD = 1.0], 94% non-Hispanic Black, 40% male) at two schools (i.e., one per summer) who were struggling academically (25-75% on a standardized reading test) were provided a free, school-based 6-week', 'children']","['HSL', 'health- and academic-focused summer program (i.e., HSL, n = 60), a 4- to 6-week academic-focused summer program (i.e., 21st Century Summer Learning program (21C), n = 60), or no summer program']","['BMI gain and academic learning loss', 'BMI gain and learning loss', 'sedentary minutes and total screen time', 'physical activity', 'sedentary minutes', 'moderate-to-vigorous physical activity (MVPA', 'healthy obesogenic behaviors']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",180.0,0.0614473,"Results Regression estimates indicated that, on days attending, HSL children experienced a greater reduction in sedentary minutes (- 58.6 [95% CI = - 92.7, - 24.4]) and a greater increase in moderate-to-vigorous physical activity (MVPA) (36.2 [95% CI = 25.1, 47.3]) and steps (2799.2","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dugger', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brazendale', 'Affiliation': 'Department of Health Sciences, University of Central Florida, Orlando, Florida USA.'}, {'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Hunt', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'Department of Implementation Science, Wake Forest School of Medicine, Winston-Salem, North Carolina USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vogler', 'Affiliation': 'Department of Instruction and Teacher Education, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Beets', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Weaver', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, South Carolina USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00617-x'] 2235,32514439,Efficacy and safety of chloroquine plus prednisone for the treatment of autoimmune hepatitis in a randomized trial.,"Background and Aim Standard treatment for autoimmune hepatitis (AIH) consists of predniso(lo)ne and azathioprine. However, alternative therapy is required for non- or partial responders and in cases of side effects. The aim of this study was to evaluate the treatment outcomes associated with chloroquine plus prednisone in AIH patients. Methods Fifty-seven patients were recruited to receive either azathioprine or chloroquine, both with prednisone, in a randomized trial. The primary end-point was complete remission, based on normalization of aminotransferase levels in the first 6 months of treatment plus maintenance for at least 18 months, with minimal or no inflammatory activity in the liver biopsy. Secondary end-points were partial and nonresponse, severe side effects, and treatment withdrawal. Results There were no differences between groups regarding clinical, serological, histological, and treatment characteristics at baseline. There were no significant differences in the biochemical response rate (67.7 vs 53.8%, P = 0.41) or the complete remission rate (32.26 vs 15.38%, P = 0.217). However, despite the long study period, the sample size was smaller than that required for a noninferiority study. The mean prednisone dose was similar in both groups. There was a nonsignificantly higher rate of adverse effects and a tendency toward improvement in glycemic and cholesterol profiles in the chloroquine group ( P = 0.09 and P = 0.07, respectively). Conclusions The combination of chloroquine and prednisone exhibited potentially beneficial effects in AIH patients (https://ClinicalTrials.gov: NCT02463331).",2020,"There were no significant differences in the biochemical response rate (67.7 vs 53.8%, P = 0.41) or the complete remission rate (32.26 vs 15.38%, P = 0.217).","['AIH patients', 'Methods\n\n\nFifty-seven patients']","['azathioprine', 'chloroquine and prednisone', 'azathioprine or chloroquine, both with prednisone', 'chloroquine', 'chloroquine plus prednisone']","['partial and nonresponse, severe side effects, and treatment withdrawal', 'complete remission', 'complete remission rate', 'Efficacy and safety', 'biochemical response rate', 'rate of adverse effects', 'glycemic and cholesterol profiles', 'normalization of aminotransferase levels']","[{'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1701941', 'cui_str': 'Treatment withdrawal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",57.0,0.235792,"There were no significant differences in the biochemical response rate (67.7 vs 53.8%, P = 0.41) or the complete remission rate (32.26 vs 15.38%, P = 0.217).","[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'T de Moraes Falcão', 'Affiliation': 'Division of Gastroenterology and Hepatology Hospital das Clinicas, University of São Paulo School of Medicine São Paulo Brazil.'}, {'ForeName': 'Debora R B', 'Initials': 'DRB', 'LastName': 'Terrabuio', 'Affiliation': 'Division of Gastroenterology and Hepatology Hospital das Clinicas, University of São Paulo School of Medicine São Paulo Brazil.'}, {'ForeName': 'Marcio A', 'Initials': 'MA', 'LastName': 'Diniz', 'Affiliation': 'Biostatistics and Bioinformatics Research Center Samuel Oschin Comprehensive Cancer Institute, Cedars Sinai Medical Center Los Angeles California USA.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'da Silva Evangelista', 'Affiliation': 'Division of Gastroenterology and Hepatology Hospital das Clinicas, University of São Paulo School of Medicine São Paulo Brazil.'}, {'ForeName': 'Fabricio G', 'Initials': 'FG', 'LastName': 'Souza', 'Affiliation': 'Division of Gastroenterology and Hepatology Hospital das Clinicas, University of São Paulo School of Medicine São Paulo Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'R Cancado', 'Affiliation': 'Division of Gastroenterology and Hepatology Hospital das Clinicas, University of São Paulo School of Medicine São Paulo Brazil.'}]",JGH open : an open access journal of gastroenterology and hepatology,['10.1002/jgh3.12258'] 2236,32514449,Hepatitis B surface antigen reduction as a result of switching from long-term entecavir administration to tenofovir.,"Background and Aim Loss of hepatitis B surface antigen (HBsAg) is an important goal in the treatment of chronic hepatitis B. We investigated whether switching from long-term entecavir (ETV) administration to tenofovir (TFV) (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF]) could contribute to the reduction of HBsAg levels. Methods The degree of HBsAg reduction by 48 weeks in 30 patients following switching from ETV to TFV was compared with results from 147 patients who continued ETV as a control. Results TFV group switched to TFV after mean 6.79 years of ETV administration. HBV-DNA levels remained below 1.0 log IU/mL in all cases in both groups during 48 weeks. Median HBsAg reduction at 48 weeks was 0.075 (-0.05 to 0.38) log/IU/mL in the TFV switch group, and 0.070 (-0.28 to 0.50) in the ETV continuation group, which was not statistically significant ( p = 0.5). In a subgroup of hepatitis B e antigen negative patients whose HBsAg had not been reduced (HBsAg reduction ≤0 log IU/mL) in the 48 weeks prior to entry into the study, HBsAg reduction was significantly higher in the TFV switch group than in the ETV continuation group (0.15 [0.07-0.135] in TFV, 0.09 [-0.14 to 0.25] log IU/mL in ETV, p = 0.04). Conclusion Although HBsAg reduction is equivalent with ETV continuation and switching to TFV in all patients at 48 weeks, switching from ETV to TFV could provide an alternative therapeutic strategy toward HBsAg elimination in a specific subpopulation of patients.",2020,"Median HBsAg reduction at 48 weeks was 0.075 (-0.05 to 0.38) log/IU/mL in the TFV switch group, and 0.070 (-0.28 to 0.50) in the ETV continuation group, which was not statistically significant ( p = 0.5).",['chronic hepatitis B'],"['switching from long-term entecavir (ETV) administration to tenofovir (TFV) (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF', 'TFV', 'hepatitis B surface antigen (HBsAg', 'tenofovir']","['degree of HBsAg reduction', 'HBsAg reduction', 'HBV-DNA levels', 'Median HBsAg reduction']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",147.0,0.0421379,"Median HBsAg reduction at 48 weeks was 0.075 (-0.05 to 0.38) log/IU/mL in the TFV switch group, and 0.070 (-0.28 to 0.50) in the ETV continuation group, which was not statistically significant ( p = 0.5).","[{'ForeName': 'Nobuharu', 'Initials': 'N', 'LastName': 'Tamaki', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kurosaki', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Kirino', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Osawa', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Higuchi', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Takaura', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Maeyashiki', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nakanishi', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Itakura', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Enomoto', 'Affiliation': 'First Department of Internal Medicine, Faculty of Medicine University of Yamanashi Kofu Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.'}]",JGH open : an open access journal of gastroenterology and hepatology,['10.1002/jgh3.12273'] 2237,32514678,Reductions of cardiovascular and metabolic risk factors after a 14-week periodized training model in patients with knee osteoarthritis: a randomized controlled trial.,"INTRODUCTION/OBJECTIVE To evaluate the effects of a periodized circuit training (CT) compared with a conventional strength training (ST) and an educational protocol (EP) on body composition, metabolic parameters, muscle strength, pain, and physical performance in patients with knee osteoarthritis (KOA). METHOD This study followed a randomized controlled trial design. A sample of sixty-one patients with KOA, 40-65 years old and BMI < 30 kg/m 2 , were randomly divided into three 14-week protocols: CT, ST, or EP. The CT performed whole body exercises organized in circuit, 3 times a week. The ST performed conventional resistance exercises also 3 times a week, and the EP joined in educational meetings twice a month. Body composition (dual-energy X-ray absorptiometry (DXA)); metabolic parameters (abdominal obesity, triglyceride, HDL, blood pressure and fasting glucose), knee maximal isometric voluntary contraction (MIVC) extension and flexion, performance-based tests (40-m walk test, 30-s chair test, and stair climb test), self-reported pain, stiffness, and physical function (WOMAC) and pain catastrophism were evaluated at baseline and follow-up. Repeated measures ANOVA were used to compare differences between groups (CTxSTxEP) at the different times of assessment (baseline × follow-up). When group-time interaction was found, a one-way ANOVA, followed by a Bonferroni post hoc test, was used to compare groups in each time point; while a paired t test was used to verify the time effect in each group. Additionally, the training effect was analyzed in terms of the percent change (Δ%). Effect size was calculated for post intervention (week 14) between groups. For all analyses a significance level of 5% was adopted (p < 0.05). RESULTS The CT was the only protocol that presented significant lower body mass (p = 0.018; Δ% = - 1.4), fat mass (p = 0.017; Δ% = - 10.3), %fat mass (p < 0.001; Δ% = - 13.9), adipose indices (%fat trunk/%fat legs p = 0.031; Δ% = 7.8; fat mass/height 2 p = 0.011; Δ% = - 15.1; trunk/limb fat mass p = 0.012; Δ% = - 8.2; visceral adipose tissue (VAT) volume (cm 3 ) p = 0.039; Δ% = - 11.6; VAT area (cm 2 ) p = 0.044; Δ% = - 12.2), blood pressure levels (SBP p = 0.042; Δ% = - 3.4 and DBP p = 0.001; Δ% = - 4.9), higher lean mass and HDL (p < 0.001; Δ% = 5.9) compared to baseline. CT and ST presented lower WOMAC pain, stiffness and physical function (p < 0.001; Δ% = - 64.0 for CT and p < 0.001; Δ% = 0.001; Δ% = - 46.4 for ST in WOMAC total score, pain catastrophizing (p < 0.001; Δ% = - 66.7 for CT and p < 0.001; Δ% = - 61.5 for ST) a higher functional performance (30 s chair test: p < 0.001; Δ% = 45.7 for CT and p < 0.001; Δ% = 26.9 for ST; 40 m walk test: p < 0.001; Δ% = 26.7 for CT and p < 0.001; Δ% = 12.5 for ST; stair climb test: p = 0.002; Δ% = - 33.9 for CT and p < 0.001; Δ% = - 18.8 for ST) and knee extension MIVC (p < 0.001; Δ% = 21.92 for CT and p < 0.001; Δ% = 30.25 for ST). CONCLUSION A periodized CT model reduces visceral adipose tissue, SBP and DBP, and improves HDL, important cardiovascular and metabolic risk factors, in patients with KOA. Both trained groups (CT and ST) improve self-reported clinical symptoms, muscle strength, and physical performance in this sample. TRIAL REGISTRATION NUMBER ClinicalTrials.gov, NCT02761590 (registered on May 4, 2016). KEY POINTS • A 14-week periodized circuit training reduces visceral adipose tissue, systolic and diastolic blood pressure, and improves HDL blood levels in patients with knee osteoarthritis.• Both periodized circuit training and conventional strength training improve clinical symptoms, functional performance and muscle strength in this sample.",2020,"CT and ST presented lower WOMAC pain, stiffness and physical function (p < 0.001; Δ% = - 64.0 for CT and p < 0.001; Δ% = 0.001; Δ% = - 46.4 for ST in WOMAC total score, pain catastrophizing (p < 0.001; Δ% = - 66.7 for CT and p < 0.001; Δ% = - 61.5 for ST) a higher functional performance (30 s chair test: p < 0.001; Δ% = 45.7 for CT and p < 0.001; Δ% = 26.9 for ST; 40 m walk test: p < 0.001; Δ% = 26.7 for CT and p < 0.001; Δ% = 12.5 for ST; stair climb test: p = 0.002; Δ% = - 33.9 for CT and p < 0.001; Δ% = - 18.8 for ST) and knee extension MIVC (p < 0.001; Δ% = 21.92 for CT and p < 0.001; Δ% = 30.25 for ST). ","['patients with knee osteoarthritis (KOA', 'patients with knee osteoarthritis.• Both', 'A sample of sixty-one patients with KOA, 40-65\xa0years old and BMI <\u200930\xa0kg/m 2', 'patients with KOA', 'patients with knee osteoarthritis']","['periodized circuit training and conventional strength training', 'periodized circuit training', 'CT, ST, or EP', 'periodized circuit training (CT', 'conventional strength training (ST) and an educational protocol (EP']","['body mass', 'visceral adipose tissue (VAT) volume', 'WOMAC pain, stiffness and physical function', 'body composition, metabolic parameters, muscle strength, pain, and physical performance', 'functional performance', 'self-reported clinical symptoms, muscle strength, and physical performance', 'adipose indices', 'visceral adipose tissue, SBP and DBP, and improves HDL, important cardiovascular and metabolic risk factors', 'fat mass', 'visceral adipose tissue, systolic and diastolic blood pressure, and improves HDL blood levels', 'Reductions of cardiovascular and metabolic risk factors', 'Body composition (dual-energy X-ray absorptiometry (DXA)); metabolic parameters (abdominal obesity, triglyceride, HDL, blood pressure and fasting glucose), knee maximal isometric voluntary contraction (MIVC) extension and flexion, performance-based tests (40-m walk test, 30-s chair test, and stair climb test), self-reported pain, stiffness, and physical function (WOMAC) and pain catastrophism', 'knee extension MIVC', 'blood pressure levels', 'WOMAC total score, pain catastrophizing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",61.0,0.0306132,"CT and ST presented lower WOMAC pain, stiffness and physical function (p < 0.001; Δ% = - 64.0 for CT and p < 0.001; Δ% = 0.001; Δ% = - 46.4 for ST in WOMAC total score, pain catastrophizing (p < 0.001; Δ% = - 66.7 for CT and p < 0.001; Δ% = - 61.5 for ST) a higher functional performance (30 s chair test: p < 0.001; Δ% = 45.7 for CT and p < 0.001; Δ% = 26.9 for ST; 40 m walk test: p < 0.001; Δ% = 26.7 for CT and p < 0.001; Δ% = 12.5 for ST; stair climb test: p = 0.002; Δ% = - 33.9 for CT and p < 0.001; Δ% = - 18.8 for ST) and knee extension MIVC (p < 0.001; Δ% = 21.92 for CT and p < 0.001; Δ% = 30.25 for ST). ","[{'ForeName': 'Aline Castilho', 'Initials': 'AC', 'LastName': 'de Almeida', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil. calmeida.aline@gmail.com.'}, {'ForeName': 'Jéssica Bianca', 'Initials': 'JB', 'LastName': 'Aily', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil.'}, {'ForeName': 'Maria Gabriela', 'Initials': 'MG', 'LastName': 'Pedroso', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil.'}, {'ForeName': 'Glaucia Helena', 'Initials': 'GH', 'LastName': 'Gonçalves', 'Affiliation': 'Integrated Health Institute, Federal University of Mato Grosso do Sul (UFMS), Campo Grande, MS, Brazil.'}, {'ForeName': 'Carlos Marcelo', 'Initials': 'CM', 'LastName': 'Pastre', 'Affiliation': 'Department of Physiotherapy, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'Stela Marcia', 'Initials': 'SM', 'LastName': 'Mattiello', 'Affiliation': 'Department of Physiotherapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil.'}]",Clinical rheumatology,['10.1007/s10067-020-05213-1'] 2238,32514702,Injection route affects intra-articular hyaluronic acid distribution and clinical outcome in viscosupplementation treatment for knee osteoarthritis: a combined cadaver study and randomized clinical trial.,"The coverage of hyaluronic acid (HA) on the impaired cartilage should be the precondition to exert its beneficial effect on knee osteoarthritis (KOA) according to the pharmacological mechanism. However, the intra-articular distribution of HA might be correlated with the route of drug delivery. Forty-two cadaver knees with radiographic evidence of osteoarthritis were given anteromedial (AM) or medial midpatellar (MMP) injection of HA (molecular weight 600-1500 kD) followed by gait stimulation. Although 2.5 ml HA delivered through both routes failed to cover the entire cartilage, HA covered 96.12% cartilage of patellofemoral joint (PFJ) and 71.44% of medial femorotibial joint (FTJ) through MMP route, whereas mainly distributed into FTJ and posterior condyles through AM route. HA in the MMP group distributed more in PFJ than that in the AM group (P < 0.001), but no significant difference presented in medial FTJ (P = 0.084). The clinical efficacy was also associated with the route of drug delivery. One hundred patients with unilateral mild-to-moderate KOA were recruited and randomly assigned to receive five weekly HA injections with AM route (n = 50) or MMP route (n = 50). Patients in the MMP group obtained better improvement in WOMAC index total score, pain score, stiffness score, and Lequesne index total score over the entire follow-up period, as compared to patients in the AM group (all P < 0.01). More patients in the MMP group claimed pain relief (71.7%, P = 0.024) and felt satisfying (63.1%, P = 0.007) than in the AM group at the end of follow-up. Therefore, intra-articular HA injection through MMP route is recommended in treating mild-to-moderate KOA. Graphical Abstract .",2020,"Patients in the MMP group obtained better improvement in WOMAC index total score, pain score, stiffness score, and Lequesne index total score over the entire follow-up period, as compared to patients in the AM group (all P < 0.01).","['knee osteoarthritis', 'Forty-two cadaver knees with radiographic evidence of osteoarthritis were given', 'One hundred patients with unilateral mild-to-moderate KOA']","['HA injections with AM route (n = 50) or MMP route', 'anteromedial (AM) or medial midpatellar (MMP) injection of HA (molecular weight 600-1500 kD) followed by gait stimulation', 'hyaluronic acid (HA', 'MMP']","['medial FTJ', 'felt satisfying', 'pain relief', 'WOMAC index total score, pain score, stiffness score, and Lequesne index total score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0447796', 'cui_str': 'Medial femorotibial joint'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}]",100.0,0.0388985,"Patients in the MMP group obtained better improvement in WOMAC index total score, pain score, stiffness score, and Lequesne index total score over the entire follow-up period, as compared to patients in the AM group (all P < 0.01).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China. orthopaedxj@163.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong.'}, {'ForeName': 'Zhi-Fa', 'Initials': 'ZF', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Wei-Zhou', 'Initials': 'WZ', 'LastName': 'Jiang', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Yu-Qiang', 'Initials': 'YQ', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Meng-Yan', 'Initials': 'MY', 'LastName': 'Jia', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Research Center for Human Tissues and Organs Degeneration Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, 518055, Guangdong Province, China.'}, {'ForeName': 'Zhan-Jun', 'Initials': 'ZJ', 'LastName': 'Shi', 'Affiliation': ""Department of Orthopaedics & Traumatology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong Province, People's Republic of China.""}]",Drug delivery and translational research,['10.1007/s13346-020-00793-6'] 2239,32514756,"Effect of zinc supplementation on quality of life and sleep quality in young women with premenstrual syndrome: a randomized, double-blind, placebo-controlled trial.","INTRODUCTION Premenstrual syndrome is a prevalent disorder affecting a large number of women in their reproductive ages. Nutritional importance of zinc has been known for a long time and studies have shown that zinc can positively affect psychological disorders. PURPOSE The aim of this study was to evaluate the effects of zinc supplementation on quality of life and sleep quality of young women diagnosed with premenstrual syndrome. METHODS This randomized, double-blind, placebo-controlled trial was carried out on 60 young university women that were allocated into two groups of intervention who took 30 mg/day of elemental zinc or placebo for three months. Pre- and post-intervention, participants completed the questionnaires of quality of life and Pittsburgh sleep quality. RESULTS After supplementation, quality of life score in the intervention group was increased (+ 9.185 ± 7.29, P < 0.001), however, in comparison with the control group, results were not significant; Physical aspects of quality of life score were significantly enhanced (+ 5.55 ± 3.71 vs. + 0.13 ± 2.87, P < 0.001). Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07). CONCLUSION Zinc supplementation for 12 weeks had beneficial effects on physical aspects of quality of life in young women with premenstrual syndrome.",2020,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07). ","['60 young university women', 'young women with premenstrual syndrome', 'young women diagnosed with premenstrual syndrome']","['Zinc supplementation', 'elemental zinc or placebo', 'zinc supplementation', 'Pre- and post-intervention', 'placebo']","['quality of life', 'questionnaires of quality of life and Pittsburgh sleep quality', 'quality of life score', 'quality of life and sleep quality', 'Physical aspects of quality of life score', 'Sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.426181,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07). ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Farhang', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05628-w'] 2240,32514794,"Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.","INTRODUCTION Many commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes. METHODS This randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon. RESULTS Of the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient. CONCLUSION Nasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia. TRIAL REGISTRATION NCT03339453, ClinicalTrials.gov.",2020,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes']","['Insulin-Induced Hypoglycaemia', 'Glucagon preparations', 'Glucagon', 'Nasal glucagon', 'intramuscular glucagon (IMG', 'Nasal glucagon (NG']",['Hypoglycaemia (plasma glucose [PG'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.229767,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Suico', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': 'Endocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00845-7'] 2241,32511015,Accommodation of Anxiety in Youth with Autism Spectrum Disorder: Results from the TAASD Study.,"OBJECTIVE Accommodation, or the ways in which families modify their routines and expectations in response to a child's anxiety, is common and interferes with anxiety treatment outcomes. However, little research has examined family accommodation among youth with autism spectrum disorder and anxiety. The current study aimed to (a) identify pre-treatment correlates of accommodation, (b) examine changes in accommodation after treatment, and (c) assess relationships between accommodation and post-treatment anxiety severity. METHOD The sample consisted of 167 youth ( mean age  = 9.90 years; 79.6% male; 18% Latinx) with clinically significant anxiety and a diagnosis of autism spectrum disorder who were enrolled in a randomized clinical trial comparing two cognitive behavioral therapy interventions for anxiety and treatment-as-usual. Participants were evaluated for symptom severity and family accommodation at pre- and post-treatment. RESULTS Results indicated that clinician-rated anxiety severity and parent-rated externalizing behaviors and autism spectrum disorder severity significantly predicted pre-treatment accommodation. Accommodation significantly decreased from pre- to post-treatment and non-responders showed significantly higher accommodation at post-treatment compared to responders. Finally, youth with higher pre-treatment accommodation had higher post-treatment anxiety. CONCLUSIONS Findings indicate that accommodation for anxiety is common among youth with autism spectrum disorder and anxiety. Furthermore, accommodation is implicated in treatment outcomes and should be targeted in treatment for youth with autism spectrum disorder and anxiety.",2020,Accommodation significantly decreased from pre- to post-treatment and non-responders showed significantly higher accommodation at post-treatment compared to responders.,"['167 youth ( mean age\xa0 =\xa09.90\xa0years; 79.6% male; 18% Latinx) with clinically significant anxiety and a diagnosis of autism spectrum disorder', 'Youth with Autism', 'youth with autism spectrum disorder and anxiety']",['cognitive behavioral therapy interventions'],"['clinician-rated anxiety severity and parent-rated externalizing behaviors and autism spectrum disorder severity', 'Accommodation of Anxiety', 'Accommodation', 'symptom severity and family accommodation']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",167.0,0.0311315,Accommodation significantly decreased from pre- to post-treatment and non-responders showed significantly higher accommodation at post-treatment compared to responders.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University.'}, {'ForeName': 'Elana R', 'Initials': 'ER', 'LastName': 'Kagan', 'Affiliation': 'Department of Psychology, Temple University.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Wood', 'Affiliation': 'Department of Education, University of California , Los Angeles.'}, {'ForeName': 'Connor M', 'Initials': 'CM', 'LastName': 'Kerns', 'Affiliation': 'Department of Psychology, University of British Columbia.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'Pediatrics and Psychiatry & Biobehavioral Sciences, University of South Florida.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'School of Aging Studies, University of South Florida.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1759075'] 2242,32511110,Effectiveness of a Home-Based Telehealth Exercise Training Program for Patients With Cardiometabolic Multimorbidity: A Randomized Controlled Trial.,"BACKGROUND Exercise training has positive effects on the management of cardiometabolic conditions. Little is known about the effectiveness of home-based telehealth exercise training programs among patients with cardiometabolic multimorbidity, which is associated with functional decline and decreased health-related quality of life. OBJECTIVE The aim of this study was to determine the effectiveness of a 12-week home-based telehealth exercise training program designed to increase physical activity and exercise capacity and improve health-related quality of life in patients with cardiometabolic multimorbidity. METHODS A randomized controlled trial was conducted. Fifty eligible patients with 2 or more cardiometabolic conditions from outpatient clinics of a medical center in Northern Taiwan were randomized to either an experimental group (EG; received a 12-week home-based telehealth exercise training program) or a control group (CG; maintained usual lifestyles). The home-based telehealth exercise training program consisted of 36 individualized home-based exercise training sessions and a weekly reminder for maintenance of exercise and providing patient support. Amounts of physical activity, exercise capacity, and health-related quality of life were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group. RESULTS The EG had higher amounts of physical activity (β = 1333, P = .004) and moderate-intensity physical activity (β = 330, P = .04) than the CG after the intervention. The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG. CONCLUSIONS A 12-week home-based telehealth exercise training program is feasible and effective in increasing amounts of physical activity, elevating exercise capacity, and improving health-related quality of life in patients with cardiometabolic multimorbidity.",2020,"The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG. ","['Fifty eligible patients with 2 or more cardiometabolic conditions from outpatient clinics of a medical center in Northern Taiwan', 'Patients With Cardiometabolic Multimorbidity', 'patients with cardiometabolic multimorbidity']","['home-based telehealth exercise training program', 'Exercise training', '36 individualized home-based exercise training sessions and a weekly reminder for maintenance of exercise and providing patient support', 'experimental group (EG; received a 12-week home-based telehealth exercise training program) or a control group (CG; maintained usual lifestyles', 'Home-Based Telehealth Exercise Training Program']","['physical activity, exercise capacity, and health-related quality of life', 'physical activity and exercise capacity and improve health-related quality of life', 'exercise capacity', 'physical activity', 'moderate-intensity physical activity', 'improved health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",50.0,0.0281242,"The EG had increased exercise capacity (VO2peak, β = 4.43, P = .04), as well as improved health-related quality of life (physical function, β = 7.55, P = .03; and physical component summary, β = 4.42, P = .03) compared with those in the CG. ","[{'ForeName': 'Shang-Lin', 'Initials': 'SL', 'LastName': 'Chiang', 'Affiliation': 'Shang-Lin Chiang, MD, PhD Assistant Professor, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. Chien-Lung Shen, PhD Director, Taiwan Textile Research Institute, Taipei, Taiwan, ROC. Liang-Cheng Chen, MD Professor, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. Yi-Pang Lo, RN, MSN Assistant Head Nurse, Department of Nursing, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, ROC. Chueh-Ho Lin, PT, PhD Assistant Professor, Master Program in Long-Term Care, Taipei Medical University; Center for Nursing and Healthcare Research in Clinical Practice Application, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan, ROC. Chia-Huei Lin, RN, PhD Assistant Professor, School of Nursing, National Defense Medical Center, and Supervisor, Department of Nursing, Songshan Branch of Tri-Service General Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yi-Pang', 'Initials': 'YP', 'LastName': 'Lo', 'Affiliation': ''}, {'ForeName': 'Chueh-Ho', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chia-Huei', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000693'] 2243,32511114,Comparing the Efficacy of Resuscitation Educational Modalities: A Randomized Study.,"This study evaluated the efficacy of online versus instructor-led advanced cardiac life support for first-time registered nurse participants. Participants were randomized into online or instructor-led courses, with learning outcomes measured in the cognitive, psychomotor, and affective domains. The instructor-led group showed statistically significant better performance during simulated megacode. Further analysis identified key areas where instructor-led participants out-performed the online group, enabling educators to articulate risk and benefit of the two learning modalities.",2020,The instructor-led group showed statistically significant better performance during simulated megacode.,['first-time registered nurse participants'],"['Resuscitation Educational Modalities', 'online versus instructor-led advanced cardiac life support']",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0887907', 'cui_str': 'Advanced cardiac life support'}]",[],,0.0524608,The instructor-led group showed statistically significant better performance during simulated megacode.,"[{'ForeName': 'Mandi D', 'Initials': 'MD', 'LastName': 'Walker', 'Affiliation': 'Mandi D. Walker, DNP, RN, CCRN-K, NPD-BC, NEA-BC, is System Executive Director of Professional Practice, University of Louisville Health, Kentucky. Bridget Nuxoll, MSN, RN, PCCN-K, NPD-BC, is Professional Development Coordinator, University of Louisville Health, Kentucky. Sherle Niner, MSN, RN-BC, is Ancillary Staff Educator, University of Louisville Hospital, Kentucky. Thomas L. Hagan, MSN, RN, CCRN-K, NPD-BC, is Resuscitation and Simulation Educator, Robley Rex Veterans Affairs Medical Center, Louisville, Kentucky.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Nuxoll', 'Affiliation': ''}, {'ForeName': 'Sherle', 'Initials': 'S', 'LastName': 'Niner', 'Affiliation': ''}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Hagan', 'Affiliation': ''}]",Journal for nurses in professional development,['10.1097/NND.0000000000000645'] 2244,31996717,Gut microbiota plasticity is correlated with sustained weight loss on a low-carb or low-fat dietary intervention.,"While low-carbohydrate and low-fat diets can both lead to weight-loss, a substantial variability in achieved long-term outcomes exists among obese but otherwise healthy adults. We examined the hypothesis that structural differences in the gut microbiota explain a portion of variability in weight-loss using two cohorts of obese adults enrolled in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) study. A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56). An additional 157 fecal samples were sequenced from the discovery cohort after 10 weeks of dietary intervention. We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts. However, the gut microbiota plasticity (i.e. variability), was correlated with long-term (12-month) weight loss in a diet-dependent manner; on the low-fat diet subjects with higher pre-diet daily plasticity had higher sustained weight loss, whereas on the low-carbohydrate diet those with higher plasticity over 10 weeks of dieting had higher 12-month weight loss. Our findings suggest the potential importance of gut microbiota plasticity for sustained weight-loss. We highlight the advantages of evaluating kinetic trends and assessing reproducibility in studies of the gut microbiota.",2020,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"['A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56', 'obese but otherwise healthy adults']",['Diet Intervention Examining'],"['weight loss', 'sustained weight loss', 'long-term (12-month) weight loss', 'gut microbiota plasticity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",161.0,0.0139624,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Grembi', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, 318 Campus Drive E250 Clark Center, Stanford, CA, 94305, United States. jgrembi@stanford.edu.'}, {'ForeName': 'Lan H', 'Initials': 'LH', 'LastName': 'Nguyen', 'Affiliation': 'Institute for Computational and Mathematical Engineering, Stanford University, 475 Via Ortega, Stanford, CA, 94305, United States.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Haggerty', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305, United States.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, 390 Serra Mall, Stanford, CA, 94305, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}]",Scientific reports,['10.1038/s41598-020-58000-y'] 2245,31812185,Challenges experienced with early introduction and sustained consumption of allergenic foods in the Enquiring About Tolerance (EAT) study: A qualitative analysis.,"BACKGROUND The early introduction group participants of the Enquiring About Tolerance study were asked to undertake a proscriptive regimen of early introduction and sustained consumption of 6 allergenic foods. It was envisaged that this might be challenging, and early introduction group families were presented with an open-text question to express any problems they were experiencing with the regimen in recurring online questionnaires. OBJECTIVE We sought to analyze these open-text questionnaire responses with the aim of identifying challenges associated with the introduction and regular consumption of allergenic foods. METHODS Three combinations of interim questionnaire responses were selected for analysis, representing the early period (4, 5, and 6 months), middle period (8 and 12 months), and late period (24 and 36 months) of participation in the Enquiring About Tolerance study. Responses were assigned a code to describe their content and subsequently grouped into themes to portray key messages. A thematic content analysis allowed for conversion of qualitative codes into quantitative summaries. RESULTS Three main challenges to allergenic food consumption were identified. First, some children refused the allergenic food, causing a sense of defeat among caregivers. Second, caregivers were concerned that allergenic foods might be causing a reaction, triggering a need for reassurance. Third, practical problems associated with the regimen compromised caregivers' capacity to persist. CONCLUSION Understanding the challenges experienced with allergenic food introduction and sustained consumption is the necessary precursor to developing specific communication and support strategies that could be used by caregivers, practitioners, policymakers, and key stakeholders to address these problems.",2019,"Understanding the challenges experienced with allergenic food introduction and sustained consumption is the necessary precursor to developing specific communication and support strategies that could be used by caregivers, practitioners, policymakers, and key stakeholders to address these problems.","['Three combinations of interim questionnaire responses were selected for analysis, representing the early period (4, 5, and 6\xa0months), middle period (8 and 12\xa0months), and late period (24 and 36\xa0months) of participation in the Enquiring About Tolerance study']",[],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0240322', 'cui_str': 'Menstrual period late'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0215001,"Understanding the challenges experienced with allergenic food introduction and sustained consumption is the necessary precursor to developing specific communication and support strategies that could be used by caregivers, practitioners, policymakers, and key stakeholders to address these problems.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Voorheis', 'Affiliation': 'Executive Office, London School of Hygiene and Tropical Medicine, London, United Kingdom; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelsen', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Quaife', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom. Electronic address: m.perkin@sgul.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.09.004'] 2246,31820841,Assessing the association between optimal energy intake and all-cause mortality in older patients with diabetes mellitus using the Japanese Elderly Diabetes Intervention Trial.,"AIM Selecting optimal energy intake during diet therapy for older patients with diabetes mellitus is difficult because of the large differences in physical function and comorbid diseases. In Japan, although requirements for total energy intake are calculated by multiplying a person's standard bodyweight (BW) by the amount of physical activity, evidence supporting the application of this method among older people is limited. Therefore, we aimed to assess optimal energy intake by evaluating the relationship between energy intake and mortality in older patients. METHODS We evaluated data from a 6-year prospective follow up of 756 older patients with diabetes mellitus, and the association between baseline nutrient intake and mortality. Total energy intake and nutrients were evaluated, and energy intake per actual BW was categorized into quartiles (Q). Cox regression analysis was used for statistical analyses. Energy intake per standard BW or age-related target BW was statistically analyzed using the same protocol. RESULTS Analysis of energy intake per actual BW showed that hazard ratios for mortality was significantly higher in Q1 and Q4. Similar associations were found for energy intake per standard or target BW. Subgroup analysis showed that mortality rate was the lowest in Q2 in the young-old population and in Q3 in the old-old population. CONCLUSIONS A U-shaped relationship was observed between energy intake per BW and mortality in older patients with diabetes mellitus, which suggests that the optimal energy intake per actual or target BW should encompass a wide range to prevent malnutrition and excessive nutrition in these patients. Geriatr Gerontol Int 2020; 20: 59-65.",2020,"RESULTS Analysis of energy intake per actual BW showed that hazard ratios for mortality was significantly higher in Q1 and Q4.","['older patients with diabetes mellitus', 'older patients with diabetes mellitus using the Japanese Elderly Diabetes Intervention Trial', '756 older patients with diabetes mellitus, and the association between baseline nutrient intake and mortality', 'older patients']",[],"['mortality rate', 'Energy intake per standard BW or age-related target BW', 'hazard ratios for mortality', 'Total energy intake and nutrients']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0326255,"RESULTS Analysis of energy intake per actual BW showed that hazard ratios for mortality was significantly higher in Q1 and Q4.","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Omura', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Training Department of Administrative Dietitians, Faculty of Human Life Science, Shikoku University, Tokushima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Center for Comprehensive Care and Research on Demented Disorders, National Center for Geriatrics and Gerontology, Aichi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatric Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Chiemi', 'Initials': 'C', 'LastName': 'Kamada', 'Affiliation': 'Training Department of Administrative Dietitians, Faculty of Human Life Science, Shikoku University, Tokushima, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iimuro', 'Affiliation': 'Innovation and Research Support Center, International University of Health and Welfare, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Araki', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Geriatrics & gerontology international,['10.1111/ggi.13820'] 2247,29676600,Searching Online for Information About Vaccination: Assessing the Influence of User-Specific Cognitive Factors Using Eye-Tracking.,"In Germany, the Internet is gaining increasing importance for laypeople as a source of health information, including information about vaccination. While previous research has focused on the characteristics of online information about vaccination, this study investigated the influence of relevant user-specific cognitive factors on users' search behavior for online information about vaccination. Additionally, it examined how searching online for information about vaccination influences users' attitudes toward vaccination. We conducted an experimental study with 56 undergraduate students from a German university that consisted of a survey and eye-tracking while browsing the Internet, followed by a content analysis of the eye-tracking data. The results show that the users exposed themselves to balanced and diverse online information about vaccination. However, none of the examined cognitive factors (attitude toward vaccination, attitude salience, prior knowledge about vaccination, need for cognition, and cognitive involvement) influenced the amount of time users spent searching the Internet for information about vaccination. Our study was not able to document any effects of attitude-consistent selective exposure to online information about vaccination. In addition, we found no effect on attitude change after having searched the Internet for vaccine-related information. Thus, users' search behavior regarding vaccination seems to be relatively stable.",2019,"In Germany, the Internet is gaining increasing importance for laypeople as a source of health information, including information about vaccination.","['56 undergraduate students from a German university that consisted of a survey and eye-tracking while browsing the Internet, followed by a content analysis of the eye-tracking data']",[],"['cognitive factors (attitude toward vaccination, attitude salience, prior knowledge about vaccination, need for cognition, and cognitive involvement', 'attitude change']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}]",56.0,0.0295355,"In Germany, the Internet is gaining increasing importance for laypeople as a source of health information, including information about vaccination.","[{'ForeName': 'Sabrina Heike', 'Initials': 'SH', 'LastName': 'Kessler', 'Affiliation': 'a IKMZ - Department of Communication and Media Research, Division Science, Crisis & Risk Communication, University of Zurich.'}, {'ForeName': 'Arne Freya', 'Initials': 'AF', 'LastName': 'Zillich', 'Affiliation': 'b Institute of Communication Research, Chair of Mediated Communication and Media Effects, Friedrich Schiller University Jena.'}]",Health communication,['10.1080/10410236.2018.1465793'] 2248,30140069,Surfactant status and respiratory outcome in premature infants receiving late surfactant treatment.,"BACKGROUND Many premature infants with respiratory failure are deficient in surfactant, but the relationship to occurrence of bronchopulmonary dysplasia (BPD) is uncertain. METHODS Tracheal aspirates were collected from 209 treated and control infants enrolled at 7-14 days in the Trial of Late Surfactant. The content of phospholipid, surfactant protein B, and total protein were determined in large aggregate (active) surfactant. RESULTS At 24 h, surfactant treatment transiently increased surfactant protein B content (70%, p < 0.01), but did not affect recovered airway surfactant or total protein/phospholipid. The level of recovered surfactant during dosing was directly associated with content of surfactant protein B (r = 0.50, p < 0.00001) and inversely related to total protein (r = 0.39, p < 0.0001). For all infants, occurrence of BPD was associated with lower levels of recovered large aggregate surfactant, higher protein content, and lower SP-B levels. Tracheal aspirates with lower amounts of recovered surfactant had an increased proportion of small vesicle (inactive) surfactant. CONCLUSIONS We conclude that many intubated premature infants are deficient in active surfactant, in part due to increased intra-alveolar metabolism, low SP-B content, and protein inhibition, and that the severity of this deficit is predictive of BPD. Late surfactant treatment at the frequency used did not provide a sustained increase in airway surfactant.",2019,"At 24 h, surfactant treatment transiently increased surfactant protein B content (70%, p < 0.01), but did not affect recovered airway surfactant or total protein/phospholipid.","['Tracheal aspirates were collected from 209 treated and control infants enrolled at 7-14 days in the Trial of Late Surfactant', 'premature infants receiving late surfactant treatment', 'premature infants with respiratory failure']",[],"['total protein', 'surfactant protein B content', 'airway surfactant', 'content of phospholipid, surfactant protein B, and total protein', 'Surfactant status and respiratory outcome', 'airway surfactant or total protein/phospholipid', 'proportion of small vesicle (inactive) surfactant']","[{'cui': 'C2919642', 'cui_str': 'Specimen from trachea obtained by aspiration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]",[],"[{'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C3544277', 'cui_str': 'Surfactant protein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0333262', 'cui_str': 'Vesicle'}]",,0.0187286,"At 24 h, surfactant treatment transiently increased surfactant protein B content (70%, p < 0.01), but did not affect recovered airway surfactant or total protein/phospholipid.","[{'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Ballard', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA. Phil.ballard@ucsf.edu.'}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Keller', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospitals and Clinics/University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Chapin', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Hart', 'Initials': 'H', 'LastName': 'Horneman', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Segal', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Roberta A', 'Initials': 'RA', 'LastName': 'Ballard', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric research,['10.1038/s41390-018-0144-3'] 2249,30409792,"Age and the Risk of Paclitaxel-Induced Neuropathy in Women with Early-Stage Breast Cancer (Alliance A151411): Results from 1,881 Patients from Cancer and Leukemia Group B (CALGB) 40101.","PURPOSE A few previous studies report a direct relationship between older age and chemotherapy-induced neuropathy. This study further evaluated this adverse event's age-based risk. METHODS CALGB 40101 investigated adjuvant paclitaxel (80 mg/m 2 once per week or 175 mg/m 2 every 2 weeks) in patients with breast cancer and served as a platform for the current study that investigated age-based differences in neuropathy. Grade 2 or worse neuropathy, as per Common Terminology Criteria for Adverse Events version 4, was the primary endpoint; patients were assessed at baseline, every 6 months for 2 years, and then annually for 15 years. RESULTS Among these 1,881 patients, 230 were 65 years of age or older, 556 were 55-64 years, and 1,095 were younger than 55; 1,226 neuropathy events (commonly grade 1 or 2) were reported in 65% of the cohort. The number of grade 2 or worse events was 63 (27%), 155 (28%), and 266 (24%) within respective age groups ( p = .14). In univariate analysis, only motor neuropathy had a higher age-based incidence: 19 (8%), 43 (8%), and 60 (5%), respectively ( p = .04); in multivariate analyses, this association was no longer statistically significant. Other endpoints, such as time to onset of neuropathy (time from trial enrollment to neuropathy development) and time to improvement (time from maximal grade sensory neuropathy to a one-category improvement), showed no statistically significant age-based differences. In contrast, obesity was associated with neuropathy, and every 2-week paclitaxel was associated with trends toward neuropathy. CONCLUSION Although paclitaxel-induced neuropathy is common, older age is not an independent risk factor. Clinical trial identification number . NCT00041119 (CALGB 40101). IMPLICATIONS FOR PRACTICE Age alone is not an independent risk factor for paclitaxel-induced neuropathy.",2019,"In univariate analysis, only motor neuropathy had a higher age-based incidence: 19 (8%), 43 (8%), and 60 (5%), respectively ( p = .04); in multivariate analyses, this association was no longer statistically significant.","['Women with Early-Stage Breast Cancer (Alliance A151411', 'patients with breast cancer and served as a platform for the current study that investigated age-based differences in neuropathy', 'older age and chemotherapy-induced neuropathy', '1,881 Patients from Cancer and Leukemia Group B (CALGB) 40101', '1,881 patients, 230 were 65 years of age or older, 556 were 55-64 years, and 1,095 were younger than 55; 1,226 neuropathy events (commonly grade 1 or 2) were reported in 65% of the cohort']",['adjuvant paclitaxel'],"['Grade 2 or worse neuropathy', 'number of grade 2 or worse events', 'time to onset of neuropathy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",,0.0583383,"In univariate analysis, only motor neuropathy had a higher age-based incidence: 19 (8%), 43 (8%), and 60 (5%), respectively ( p = .04); in multivariate analyses, this association was no longer statistically significant.","[{'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Barginear', 'Affiliation': 'Northwell Health Cancer Institute, New York New York, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona, USA.'}, {'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Allred', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Bunnell', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Center for the Study of Aging and Human Development and, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': 'City of Hope, Duarte, California, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Kimmick', 'Affiliation': 'Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lichtman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Commack, New York, USA.'}, {'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lawrence N', 'Initials': 'LN', 'LastName': 'Shulman', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'M Sitiki', 'Initials': 'MS', 'LastName': 'Copur', 'Affiliation': 'Saint Francis Cancer Treatment Center, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Biggs', 'Affiliation': 'Christiana Care Health System-Christiana Hospital, Newark, Delaware, USA.'}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lafky', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Jatoi', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA jatoi.aminah@mayo.edu.'}]",The oncologist,['10.1634/theoncologist.2018-0298'] 2250,30465187,Future Liver Remnant (FLR) Increase in Patients with Colorectal Liver Metastases Is Highest the First Week After Portal Vein Occlusion : FLR Increase in Patients with CRLM Is Highest the First Week After PVO.,"BACKGROUND Portal vein occlusion (PVO) is an established method to increase the volume of the future liver remnant (FLR). The main reasons for not proceeding to radical hepatectomy are lack of volume increase and tumor progression due to a wait-time interval of up to 8 weeks. The hypothesis was that the increase in FLR volume is not linear and is largest during the first weeks. METHODS Patients with colorectal liver metastases (CRLM) and standardized future liver remnant (sFLR) < 30% treated with PVO were prospectively included. All patients had at least one CT evaluation before radical hepatectomy. RESULTS Forty-eight patients were included. During the first week after PVO, the kinetic growth rate (KGR) was 5.4 (± 4), compared to 1.5 (± 2) between the first and second CT (p < 0.05). For patients reaching adequate FLR and therefore treated with radical hepatectomy, the KGR was 7 (± 4) the first week, compared to 4.3 (± 2) for patients who failed to reach a sufficient volume (p = 0.4). During the interval between the first and second CT, the KGR was 2.2 (± 2), respectively (± 0.1) (p = 0.017). DISCUSSION The increase in liver volume after PVO is largest during the first week. As KGR decreases over time, it is important to shorten the interval between PVO and the first volume evaluation; this may aid in decision-making and reduce unnecessary waiting time.",2019,"For patients reaching adequate FLR and therefore treated with radical hepatectomy, the KGR was 7 (± 4) the first week, compared to 4.3 (± 2) for patients who failed to reach a sufficient volume (p = 0.4).","['All patients had at least one CT evaluation before radical hepatectomy', '\u200930% treated with PVO', 'Forty-eight patients were included', 'Patients with CRLM', 'Patients with colorectal liver metastases (CRLM) and standardized future liver remnant (sFLR', 'Patients with Colorectal Liver Metastases']","['Portal vein occlusion (PVO', 'radical hepatectomy']","['liver volume', 'FLR volume', 'kinetic growth rate (KGR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0265029', 'cui_str': 'Portal vein obstruction'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]","[{'cui': 'C0265029', 'cui_str': 'Portal vein obstruction'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",48.0,0.0129208,"For patients reaching adequate FLR and therefore treated with radical hepatectomy, the KGR was 7 (± 4) the first week, compared to 4.3 (± 2) for patients who failed to reach a sufficient volume (p = 0.4).","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Hasselgren', 'Affiliation': 'Departments of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sandström', 'Affiliation': 'Departments of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Bård Ingvald', 'Initials': 'BI', 'LastName': 'Røsok', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Sparrelid', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Lindell', 'Affiliation': 'Department of Surgery, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter Nørgaard', 'Initials': 'PN', 'LastName': 'Larsen', 'Affiliation': 'Department of Surgical Gastroenterology and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anna Lindhoff', 'Initials': 'AL', 'LastName': 'Larsson', 'Affiliation': 'Departments of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Nicolai A', 'Initials': 'NA', 'LastName': 'Schultz', 'Affiliation': 'Department of Surgical Gastroenterology and Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bjorn Atle', 'Initials': 'BA', 'LastName': 'Björnbeth', 'Affiliation': 'Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Isaksson', 'Affiliation': 'Department of Surgery, Akademiska University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rizell', 'Affiliation': 'Department of Transplantation and Liver Surgery, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bergthor', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Departments of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. bergthor.bjornsson@liu.se.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-4031-3'] 2251,30714500,Controlled comparative clinical trial of hearing benefit outcomes for users of the Cochlear™ Nucleus ® 7 Sound Processor with mobile connectivity.,"OBJECTIVES To assess subjective benefits and objective speech recognition performance following a take-home trial with the new Cochlear™ Nucleus ® 7 Sound Processor (SP), in experienced users of compatible cochlear implants from Cochlear Limited. METHODS A total of 37 adult participants were fitted with the Nucleus 7 SP and used the device for up to one year. Baseline speech recognition was assessed at the initial fitting session, using each participant's own SP, and Client Oriented Scale of Improvement (COSI) goals were identified. Speech recognition was measured after 3 months of device use and outcomes of the COSI and a non-validated Processor Comparison Questionnaire (PCQ) were collected. After 11 months, a subset of subjects were tested on speech recognition delivered via direct wireless streaming from an Apple ® smartphone to the SP and compatible hearing aid on the opposite side (if worn). RESULTS The COSI and PCQ instruments both indicated significant improvement in perceived subjective benefits in comparison to the participants' previous SPs. Direct streaming via an Apple mobile phone showed improvements when compared with the acoustic alone condition. Standard speech recognition in quiet and noise was equivalent to that obtained using a previous generation SP which uses the same basic processing as the Nucleus 7 Sound Processor. CONCLUSIONS The incremental refinements provided by the Nucleus 7 Sound Processor provide real-world benefits in key areas such as upgraded wireless connectivity. The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.",2019,The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.,"['users of the Cochlear™ Nucleus ® 7 Sound Processor with mobile connectivity', '37 adult participants', 'experienced users of compatible cochlear implants from Cochlear Limited']","['Direct streaming via an Apple mobile phone', 'new Cochlear™ Nucleus ® 7 Sound Processor (SP']","['subjective benefits and objective speech recognition performance', 'Speech recognition', 'COSI and a non-validated Processor Comparison Questionnaire (PCQ', 'subjective benefits', 'Baseline speech recognition']","[{'cui': 'C0009195', 'cui_str': 'Cochlear structure'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009195', 'cui_str': 'Cochlear structure'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",37.0,0.0405595,The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.,"[{'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Warren', 'Affiliation': 'a Cochlear Ltd , Sydney , Australia.'}, {'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Nel', 'Affiliation': 'a Cochlear Ltd , Sydney , Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Boyd', 'Affiliation': 'a Cochlear Ltd , Sydney , Australia.'}]",Cochlear implants international,['10.1080/14670100.2019.1572984'] 2252,30950636,Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation.,,2019,,['Individuals with Idiopathic Pulmonary Fibrosis'],['Pirfenidone'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}]",[],,0.0202373,,"[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': '1 Royal Brompton Hospital London, United Kingdom.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lancaster', 'Affiliation': '3 Vanderbilt University Medical Center Nashville, Tennessee.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': '4 Pontchaillou University Hospital Rennes, France.'}, {'ForeName': 'Lake', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': '6 Duke University Medical Center Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': '7 Columbia University Medical Center New York, New York.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Molina-Molina', 'Affiliation': ""8 Institut d'Investigació Biomèdica de Bellvitge Barcelona, Spain.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': '10 Aarhus University Hospital Aarhus, Denmark.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': '11 F. Hoffmann-La Roche, Ltd. Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': '11 F. Hoffmann-La Roche, Ltd. Basel, Switzerland.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Axmann', 'Affiliation': '11 F. Hoffmann-La Roche, Ltd. Basel, Switzerland.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Petzinger', 'Affiliation': '12 Accovion GmbH Eschborn, Germany and.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Noble', 'Affiliation': '13 Cedars-Sinai Medical Center Los Angeles, California.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201810-720RL'] 2253,31092548,Low systemic arterial compliance is associated with increased cardiovascular morbidity and mortality in aortic valve stenosis.,"OBJECTIVE Lower systemic arterial compliance (SAC) is associated with increased cardiovascular morbidity and mortality in hypertension, but this has not been assessed in a prospective study in aortic valve stenosis (AS). METHODS Data from 1641 patients (38% women) with initially asymptomatic mild-moderate AS enrolled in the Simvastatin and Ezetimibe in Aortic Stenosis study was used. Median follow-up was 4.3 years. SAC was assessed from Doppler stroke volume index to central pulse pressure ratio and considered low if ≤0.64 mL/m², corresponding to the lower tertile in the population. The association of SAC with outcome was assessed in Cox regression analysis and reported as HR and 95% CI. RESULTS Low SAC at baseline was characterised by older age, female sex, hypertension, obesity, presence of a small aortic root, lower mean aortic gradient and more severe AS by effective aortic valve area (all p<0.01). In Cox regression analysis adjusting for factors, low SAC was associated with higher HRs for cardiovascular death (HR 2.13(95% CI 1.34 to 3.40) and all-cause mortality (HR 1.71(95% CI 1.23 to 2.38)), both p=0.001). The results did not change when systolic or diastolic blood pressure, other measures of AS severity or presence of discordantly graded AS were included in subsequent models. Presence of low SAC did not improve mortality prediction in reclassification analysis. CONCLUSIONS In patients with AS without diabetes and known cardiovascular disease, but a high prevalence of hypertension, low SAC was associated with higher cardiovascular and all-cause mortality independent of well-known prognosticators. TRIAL REGISTRATION NUMBER NCT00092677; Post-results.",2019,"In Cox regression analysis adjusting for factors, low SAC was associated with higher HRs for cardiovascular death (HR 2.13(95% CI 1.34 to 3.40) and all-cause mortality (HR 1.71(95% CI 1.23 to 2.38)), both p=0.001).","['Data from 1641 patients (38% women) with initially asymptomatic mild-moderate AS enrolled in the', 'aortic valve stenosis (AS', 'in Aortic Stenosis study was used', 'aortic valve stenosis']",['Simvastatin and Ezetimibe'],"['cardiovascular death', 'cardiovascular morbidity and mortality', 'Doppler stroke volume index to central pulse pressure ratio', 'systolic or diastolic blood pressure', 'mortality prediction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1532737', 'cui_str': 'simvastatin and ezetimibe'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",1641.0,0.128182,"In Cox regression analysis adjusting for factors, low SAC was associated with higher HRs for cardiovascular death (HR 2.13(95% CI 1.34 to 3.40) and all-cause mortality (HR 1.71(95% CI 1.23 to 2.38)), both p=0.001).","[{'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Bahlmann', 'Affiliation': 'Department of Cardiology, Asklepios Clinic St. Georg, Hamburg, Germany.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Cramariuc', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Sahrai', 'Initials': 'S', 'LastName': 'Saeed', 'Affiliation': 'Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Chambers', 'Affiliation': 'Department of Cardiology, Cardiothoracic Centre, Guys and St Thomas Hospital, London, UK.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Nienaber', 'Affiliation': 'Department of Cardiology, Imperial College, the Royal Brompton and Harefield Trust, Cardiology and Aortic Centre, London, UK.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'Department of Cardiology, Asklepios Clinic St. Georg, Hamburg, Germany.'}, {'ForeName': 'Mai Tone', 'Initials': 'MT', 'LastName': 'Lønnebakken', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gerdts', 'Affiliation': ''}]",Heart (British Cardiac Society),['10.1136/heartjnl-2018-314386'] 2254,32510644,Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 2-year results of an RCT using 3D digital measuring for volumetric comparison of gingival dimensions.,"AIM The aim of this randomized clinical trial (RCT) was to compare clinical and volumetric outcomes of tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD) 2 years after gingival recession (GR) treatment. MATERIALS AND METHODS 23 patients contributed 45 Miller class I or II GR. At baseline and follow-up examinations, study models were collected. Their three-dimensional scans allowed precise computer-assisted measurement of recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness. Clinical examination delivered probing depths (PPD) and height of keratinized tissue (HKT). RESULTS 24 months after surgery, digitally evaluated CRC was present in 60.0% of the TUN+CTG and 0.0% of the CAF+EMD treated sites (p<0.0001), meaning a certain relapse of the gingival margin ragarding both approaches. RC amounted to 94.0% (TUN+CTG) and 57.3% (CAF+EMD) respectively (p<0.0001). REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001). pTHK and aTHK values were significantly greater in the TUN+CTG group (1.41±0.35mm and 1.11±0.26 mm) than in the CAF+EMD group (0.78±0.32mm and 0.60±0.26mm) (p<0.0001). Statistical analysis detected positive correlations between THK and both RC and RECred (p<0.001). CONCLUSIONS Two years post-operatively, CTG showed better clinical and volumetric outcomes than EMD. Increased THK values were associated with improved outcomes regarding RC and RECred.",2020,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,['23 patients contributed 45 Miller class I or II GR'],"['TUN+CTG', 'Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate', 'tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD']","['REC reduction (RECred', 'Clinical examination delivered probing depths (PPD) and height of keratinized tissue (HKT', 'RC', 'recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness', 'pTHK and aTHK values', 'Increased THK values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C0080232', 'cui_str': 'Transplantation, Tissue'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0465349,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,"[{'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Zuhr', 'Affiliation': 'Dentist, Private Practice Hürzeler/Zuhr, Munich, Germany.'}, {'ForeName': 'Stephan F', 'Initials': 'SF', 'LastName': 'Rebele', 'Affiliation': 'Dentist, Private Practice Rebele, Dinkelsbühl, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Mathematician & Research Associate, Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Germany.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Petsos', 'Affiliation': 'Research Assistent, Department of Periodontology, Center of Dentistry and Oral Health (Carolinum), Johann Wolfgang Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Hürzeler', 'Affiliation': 'Dentist, Private Practice Hürzeler/Zuhr, Munich, Germany.'}]",Journal of clinical periodontology,['10.1111/jcpe.13328'] 2255,32510696,"Biomarkers of oxidative stress and inflammation in people witha physical disability treated with a standardized extract of Nasturtium officinale: A randomized, double-blind, and placebo-controlled trial.","It is well established that plants from the Brassicaceae family, particularly watercress, have been associated to reduce oxidative DNA damage. Nasturtium officinale R. Br (watercress) contains glucosinolates, with anti-inflammatory action and protective effect on human health against oxidative stress. We aimed to evaluate whether the standardized extract of Nasturtium officinale (SENO) is capable of changing biomarkers of oxidative stress and inflammation in people with physical disabilities. 65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750 mg/kg/day of SENO, and 25 people with physical disabilities using 750 mg/kg/day of placebo-control for 5 weeks. Biomarkers of oxidative stress and inflammation were analyzed on day 0 and 36. The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein. Furthermore, the cytokine kit demonstrated below and out of invertible range, which was impossible to detect the inflammatory process. Despite the cytokine kit was not able to detect the inflammation; these data might provide supportive evidence that SENO, have affected positively people with physical disabilities decreasing their biomarkers of oxidative stress and C-reactive protein. Further studies are required.",2020,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","['people witha physical disability treated with a standardized extract of Nasturtium officinale', 'people with physical disabilities', '65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750\u2009mg/kg/day of SENO, and 25 people with physical disabilities using 750\u2009mg/kg/day of']","['SENO', 'standardized extract of Nasturtium officinale (SENO', 'placebo-control for 5\u2009weeks', 'placebo']","['levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",65.0,0.179116,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","[{'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Marilis D', 'Initials': 'MD', 'LastName': 'Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Felipe', 'Affiliation': 'Department of Biochemistry, Federal University of Parana, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gribner', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'F Moura', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Ana Angelica', 'Initials': 'AA', 'LastName': 'R Rigoni', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'B Parisotto', 'Affiliation': 'School of Pharmaceutical Sciences, Food and Nutrition, Federal University of Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'T Piltz', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Glaucio', 'Initials': 'G', 'LastName': 'Valdameri', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Railson', 'Initials': 'R', 'LastName': 'Henneberg', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'B Schonhofen', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'S Carvalho', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Luiz Claudio', 'Initials': 'LC', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Federal University of Parana, Brazil.'}, {'ForeName': 'Obdúlio', 'Initials': 'O', 'LastName': 'G Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6718'] 2256,32510734,Azithromycin and COVID-19Prompt Early Use at First Signs of this Infection in Adults and Children An Approach Worthy of Consideration.,"The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually-randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide (ACTION)"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2 g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for four days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for four days. This article is protected by copyright. All rights reserved.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics & Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California.'}]",Dermatologic therapy,['10.1111/dth.13785'] 2257,32505193,Exercise training alone or in combination with high-protein diet in patients with late onset Pompe disease: results of a cross over study.,"BACKGROUND Late onset Pompe disease (LOPD) is a lysosomal neuromuscular disorder which can progressively impair the patients' exercise tolerance, motor and respiratory functions, and quality of life. The available enzyme replacement therapy (ERT) does not completely counteract disease progression. We investigated the effect of exercise training alone, or associated with a high-protein diet, on the exercise tolerance, muscle and pulmonary functions, and quality of life of LOPD patients on long term ERT. METHODS The patients were asked to participate to a crossover randomized study comprehending a control period (free diet, no exercise) followed by 2 intervention periods: exercise or exercise + diet, each lasting 26 weeks and separated by 13 weeks washout periods. Exercise training included moderate-intensity aerobic exercise on a cycle ergometer, stretching and balance exercises, strength training. The diet was composed by 25-30% protein, 30-35% carbohydrate and 35-40% fat. Before and after each period patients were assessed for: exercise tolerance test on a cycle-ergometer, serum muscle enzymes, pulmonary function tests and SF36 questionnaire for quality of life. Compliance was evaluated by training and dietary diaries. Patients were contacted weekly by researchers to optimize adherence to treatments. RESULTS Thirteen LOPD patients, median age 49 ± 11 years, under chronic ERT (median 6.0 ± 4.0 years) were recruited. Peak aerobic power (peak pulmonary O 2 uptake) decreased after control, whereas it increased after exercise, and more markedlyafter exercise + diet. Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise. Pulmonary function showed no changes after control and exercise, whereas a significant improvement of forced expiratory volume in 1 sec (FEV1) was observed after exercise + diet. SF36 showed a slight improvement in the ""mental component"" scale after exercise, and a significant improvement in ""general health"" and ""vitality"" after exercise + diet. The compliance to prescriptions was higher than 70% for both diet and exercise. CONCLUSIONS Exercise tolerance (as evaluated by peak aerobic power) showed a tendency to decrease in LOPD patients on long term ERT. Exercise training, particularly if combined with high-protein diet, could reverse this decrease and result in an improvement, which was accompanied by improved quality of life. The association of the two lifestyle interventions resulted also in a reduction of muscle enzyme levels and improved pulmonary function.",2020,Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise.,"['Thirteen LOPD patients, median age 49\u2009±\u200911\u2009years, under chronic ERT (median 6.0\u2009±\u20094.0\u2009years) were recruited', 'patients with late onset Pompe disease']","['exercise training alone', 'Exercise training', 'enzyme replacement therapy (ERT', 'control period (free diet, no exercise) followed by 2 intervention periods: exercise or exercise\u2009+\u2009diet', 'Exercise training alone or in combination with high-protein diet', 'Exercise training included moderate-intensity aerobic exercise on a cycle ergometer, stretching and balance exercises, strength training']","['quality of life', 'exercise tolerance test on a cycle-ergometer, serum muscle enzymes, pulmonary function tests and SF36 questionnaire for quality of life', 'general health"" and ""vitality', 'Peak aerobic power (peak pulmonary O 2 uptake', 'Serum levels of lactate dehydrogenase (LDH', 'exercise tolerance, muscle and pulmonary functions, and quality of life', 'mental component"" scale', 'creatine kinase (CK) and LDH levels', 'muscle enzyme levels and improved pulmonary function', 'forced expiratory volume in 1 sec (FEV1']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0342753', 'cui_str': 'Glycogen storage disease due to acid maltase deficiency, late-onset'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141895', 'cui_str': 'Muscle enzyme'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",13.0,0.0120145,Serum levels of lactate dehydrogenase (LDH) significantly decreased after exercise + diet; both creatine kinase (CK) and LDH levels were significantly reduced after exercise + diet compared to exercise.,"[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Sechi', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy. annalisa.sechi@asufc.sanita.fvg.it.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Zuccarelli', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Frangiamore', 'Affiliation': 'Neuroimmunology and Muscle Pathology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'De Amicis', 'Affiliation': 'International Center for the Assessment of Nutritional Status (ICANS), Department of Food Environmental and Nutritional Sciences (DeFENS), University of Milan, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Marzorati', 'Affiliation': 'Institute of Biomedical Technologies, National Research Council, Segrate, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Porcelli', 'Affiliation': 'Institute of Biomedical Technologies, National Research Council, Segrate, Italy.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Tullio', 'Affiliation': 'Institute of Hygiene and Clinical Epidemiology, Academic hospital of Udine, Udine, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bacco', 'Affiliation': 'Division of Endocrinology, Metabolic Diseases and Nutrition, Academic Hospital of Udine, Udine, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bertoli', 'Affiliation': 'International Center for the Assessment of Nutritional Status (ICANS), Department of Food Environmental and Nutritional Sciences (DeFENS), University of Milan, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dardis', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Biasutti', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Maria Barbara', 'Initials': 'MB', 'LastName': 'Pasanisi', 'Affiliation': 'Neuroimmunology and Muscle Pathology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Devigili', 'Affiliation': 'Neurological Unit 1, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bembi', 'Affiliation': 'Regional Coordinator Center for Rare Diseases, Academic hospital of Udine, p.zzale SM della Misericordia 15, 33100, Udine, Italy.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01416-6'] 2258,32505213,"A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA.","BACKGROUND Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is the current standard therapy for diffuse large B cell lymphoma (DLBCL). Obinutuzumab (G), a glycoengineered, type II anti-CD20 monoclonal antibody, has shown activity and an acceptable safety profile when combined with CHOP (G-CHOP) in patients with advanced DLBCL. We present the final analysis results of the Phase III GOYA study (NCT01287741), which compared the efficacy and safety of G-CHOP versus R-CHOP in patients with previously untreated DLBCL. METHODS Patients aged ≥ 18 years with previously untreated advanced DLBCL were randomly assigned to receive eight 21-day cycles of R or G, plus six or eight cycles of CHOP. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS by cell of origin subgroup was an exploratory endpoint. RESULTS A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710). Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48). The results of the secondary efficacy endpoints did not show a benefit of G-CHOP over R-CHOP. In the exploratory analysis, a trend towards benefit with G-CHOP over R-CHOP was apparent in the patients with germinal center B cell DLBCL. The safety profile of G-CHOP was as expected, and no new safety signals were observed. More grade 3-5 (75.1% vs 65.8%), serious (44.4% vs 38.4%), and fatal (6.1% vs 4.4%) adverse events (AEs) were observed in the G-CHOP arm compared with the R-CHOP arm, respectively, with the most common fatal AEs being infections. A higher incidence of late-onset neutropenia occurred in the G-CHOP arm (8.7%) versus the R-CHOP arm (4.9%). CONCLUSIONS The final analysis, similar to the primary analysis, did not show a PFS benefit of G-CHOP over R-CHOP in previously untreated patients with DLBCL. The results of the secondary endpoints were consistent with the primary endpoint. Further exploratory analyses and investigation of biomarkers are ongoing.",2020,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","['patients with advanced DLBCL', 'patients with germinal center B cell DLBCL', 'patients with previously untreated DLBCL', 'A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710', 'diffuse large B cell lymphoma (DLBCL', 'patients with previously untreated diffuse large B-Cell lymphoma', 'Patients aged ≥ 18\u2009years with previously untreated advanced DLBCL']","['obinutuzumab or rituximab plus CHOP', 'Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP', 'R or G, plus six or eight cycles of CHOP', 'G-CHOP', 'G-CHOP versus R-CHOP', 'CHOP (G-CHOP', 'Obinutuzumab (G']","['investigator-assessed progression-free survival (PFS', 'overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS', 'benefit of G-CHOP over R-CHOP', 'PFS benefit of G-CHOP', 'efficacy and safety', 'late-onset neutropenia', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0282491', 'cui_str': 'Structure of germinal center of lymph node'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3805247', 'cui_str': 'Late onset neutropenia'}]",1418.0,0.285844,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, BC, Canada. Lsehn@bccancer.bc.ca.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Martelli', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trněný', 'Affiliation': 'Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Roche Pharma Development, Shanghai, China.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Sahin', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Sellam', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Candiolo Cancer Institute, FPO-IRCCS, (Turin), Candiolo, Italy.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00900-7'] 2259,32505378,[Impact of post-thoracotomy analgesia with dexmedetomidine and morphine on immunocytes: a randomized clinical trial].,"OBJECTIVE This study aimed to investigate the impact of post-thoracotomy analgesia with dexmedetomidine and morphine on immunocytes. METHODS A total of 118 patients with post-thoracotomy Patient-Controlled Intravenous Analgesia (PCIA) in our hospital from March 2016 to July 2018 were randomly selected and divided into the Composite (COM) Group (57 patients administered with dexmedetomidine [1.0 μg.kg -1 body weight] and morphine [0.48 mg.kg -1 body weight]) and the Morphine (MOR) Group (61 patients administered with morphine [0.48 mg.kg -1 ]). The values of lymphocyte subsets (CD3+, CD4+, and CD8+) and Natural Killer cells in the peripheral blood of these two groups were detected by FACSCalibur flow cytometry at different time points (before anesthesia induction [T0], immediately after tracheal extubation [T1], 12 hours after surgery [T2], 24 hours after surgery [T3], 48 hours after surgery [T4], 72 hours after surgery [T5], and 7 days after surgery [T6]). The doses of morphine at T3 to T5 and the adverse reactions between the two groups were also recorded and compared. RESULTS The CD3+ level and the CD4+/CD8+ ratio at T2 to T5 and the CD4+ level and NK cells at T3 to T5 were significantly higher in the COM Group than in the MOR Group (p < 0.05). The postoperative morphine dose and the incidence of postoperative itching, nausea, and vomiting were significantly lower in the COM Group than in the MOR Group (p < 0.05). CONCLUSIONS Dexmedetomidine combined with morphine for post-thoracotomy PCIA can improve the function of immunocytes, reduce morphine consumption, and reduce the adverse reactions during analgesia induction.",2020,"The postoperative morphine dose and the incidence of postoperative itching, nausea, and vomiting were significantly lower in the COM Group than in the MOR Group (p < 0.05). ",['118\xa0patients with post-thoracotomy Patient-Controlled Intravenous Analgesia (PCIA) in our hospital from March\xa02016 to July\xa02018'],"['Dexmedetomidine', 'Morphine (MOR', 'COM', 'dexmedetomidine and morphine', 'dexmedetomidine', 'morphine']","['CD4+ level and NK cells', 'function of immunocytes, reduce morphine consumption', 'postoperative itching, nausea, and vomiting', 'CD3+ level and the CD4+/CD8+ ratio', 'adverse reactions', 'values of lymphocyte subsets (CD3+, CD4+, and CD8+) and Natural Killer cells', 'immunocytes']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1138348', 'cui_str': 'moira protein, Drosophila'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0312737', 'cui_str': 'Immunologic cell'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}]",,0.073553,"The postoperative morphine dose and the incidence of postoperative itching, nausea, and vomiting were significantly lower in the COM Group than in the MOR Group (p < 0.05). ","[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Shenzhen University General Hospital, Operation Department, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.""}, {'ForeName': 'Weichun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China. Electronic address: cnpengfeilei@163.com.""}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Shan', 'Affiliation': ""Department of Emergency, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, China. Electronic address: abv236@126.com.""}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.017'] 2260,32505379,"Corrigendum to Rounding, but not randomization method, non-normality, or correlation, affected baseline P-value distributions in randomized trials. J Clin Epidemiol 2019;110:50-62.",,2020,,[],[],[],[],[],[],,0.0725512,,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Bolland', 'Affiliation': 'Department of Medicine, University of Auckland, Private Bag 92 019, Auckland 1142, New Zealand. Electronic address: m.bolland@auckland.ac.nz.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, University of Auckland, Private Bag 92 019, Auckland 1142, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, Scotland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grey', 'Affiliation': 'Department of Medicine, University of Auckland, Private Bag 92 019, Auckland 1142, New Zealand.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.05.017'] 2261,32505383,"Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial.","OBJECTIVE To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP). DESIGN A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial. SETTING Clinical centers. PATIENT(S) Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP. INTERVENTION(S) The interventions were 50, 75, 100, or 200 mg linzagolix (or matching placebo) administered once daily for 24 weeks. MAIN OUTCOME MEASURE(S) The primary endpoint was the number of responders (≥30% reduction in overall pelvic pain) after 12 weeks. Other endpoints included dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD). RESULT(S) Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively). A similar pattern was seen for dysmenorrhea and non-menstrual pelvic pain. The effects were maintained or increased at 24 weeks. Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion. Mean BMD loss (spine) at 24 weeks was <1% at doses of 50 and 75 mg and increased in a dose-dependent fashion up to 2.6% for 200 mg. BMD of femoral neck and total hip showed a similar pattern. CONCLUSION(S) Linzagolix significantly reduced EAP and improved QoL at doses of 75-200 mg and decreased BMD dose-dependently. CLINICAL TRIAL REGISTRATION NUMBER NCT02778399.",2020,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","['Clinical centers', 'Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP']","['oral gonadotropin-releasing hormone-antagonist', 'linzagolix (or matching placebo', 'gonadotropin-releasing hormone antagonist, linzagolix', 'placebo']","['EAP and improved QoL', 'Mean BMD loss (spine', 'BMD of femoral neck and total hip', 'proportion of responders for overall pelvic pain', 'number of responders', 'rate of amenorrhea', 'overall pelvic pain', 'dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD', 'dysmenorrhea and non-menstrual pelvic pain', 'Serum estradiol']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.615483,"Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively).","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donnez', 'Affiliation': ""Société de recherche pour l'infertilité, Catholic University of Louvain, Belgium.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Akin', 'Affiliation': 'Austin Area Obstetrics Gynecology and Fertility, Austin, Texas.'}, {'ForeName': 'Tatyana F', 'Initials': 'TF', 'LastName': 'Tatarchuk', 'Affiliation': 'Department of Endocrine Gynecology, Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': 'Vita Longa Sp. z o.o, Katowice, Poland.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Gotteland', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Lecomte', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Bestel', 'Affiliation': 'ObsEva S.A, Geneva, Switzerland. Electronic address: elke.bestel@obseva.ch.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.02.114'] 2262,32505710,Inter-individual differences in the responses to aerobic exercise in Alzheimer's disease: Findings from the FIT-AD trial.,"BACKGROUND Despite the strong evidence of aerobic exercise as a disease-modifying treatment for Alzheimer's disease (AD) in animal models, its effects on cognition are inconsistent in human studies. A major contributor to these findings is inter-individual differences in the responses to aerobic exercise, which was well documented in the general populations but not in AD. The purpose of this study was to examine inter-individual differences in aerobic fitness and cognitive responses to a 6-month aerobic exercise intervention in community-dwelling older adults with mild-to-moderate AD dementia. METHODS This study was a secondary analysis of the FIT-AD Trial data. Aerobic fitness was measured with the shuttle walk test (SWT), 6-minute walk test (6MWT), and maximal oxygen consumption (VO 2max ) test, and cognition with the AD Assessment Scale-Cognition (ADAS-Cog). Inter-individual differences were calculated as the differences in the standard deviation of 6-month change (SD R ) in the SWT, 6MWT, VO 2max , and ADAS-Cog between the intervention and control groups. RESULTS Seventy-eight participants were included in this study (77.4 ± 6.3 years old, 15.7 ± 2.8 years of education, mean ± SD; 41% women). VO2max was available in 26 participants (76.2 ± 8.0 years old, 14.8 ± 2.7 years of education, mean ± SD; 31% women). The SD R was 37.0, 121.1, 1.7, and 2.3 for SWT, 6MWT, VO 2max, and ADAS-Cog, respectively. CONCLUSION There are true inter-individual differences in aerobic fitness and cognitive responses to aerobic exercise in older adults with mild-to-moderate AD dementia. These inter-individual differences likely underline the inconsistent cognitive benefits in human studies.",2020,"The SD R was 37.0, 121.1, 1.7, and 2.3 for SWT, 6MWT, VO 2max, and ADAS-Cog, respectively. ","['26 participants (76.2 ± 8.0 years old, 14.8 ± 2.7 years of education, mean ± SD; 31% women', ""Alzheimer's disease"", 'older adults with mild-to-moderate AD dementia', 'community-dwelling older adults with mild-to-moderate AD dementia', 'Seventy-eight participants were included in this study (77.4 ± 6.3 years old, 15.7 ± 2.8 years of education, mean ± SD; 41% women']","['aerobic exercise intervention', 'aerobic exercise']","['Aerobic fitness', 'standard deviation of 6-month change (SD R ) in the SWT, 6MWT, VO 2max , and ADAS-Cog', 'aerobic fitness and cognitive responses', 'shuttle walk test (SWT), 6-minute walk test (6MWT), and maximal oxygen consumption (VO 2max ) test, and cognition with the AD Assessment Scale-Cognition (ADAS-Cog']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319697', 'cui_str': '6.3'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}]",78.0,0.129868,"The SD R was 37.0, 121.1, 1.7, and 2.3 for SWT, 6MWT, VO 2max, and ADAS-Cog, respectively. ","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Adult and Gerontological Health Cooperative, University of Minnesota School of Nursing, Minneapolis, Minnesota, 55455, USA. Electronic address: yuxxx244@umn.edu.'}, {'ForeName': 'Dereck', 'Initials': 'D', 'LastName': 'Salisbury', 'Affiliation': 'Adult and Gerontological Health Cooperative, University of Minnesota School of Nursing, Minneapolis, Minnesota, 55455, USA.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Mathiason', 'Affiliation': 'Adult and Gerontological Health Cooperative, University of Minnesota School of Nursing, Minneapolis, Minnesota, 55455, USA.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.05.007'] 2263,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity. STUDY DESIGN Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests. RESULTS The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10. CONCLUSION These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996'] 2264,32505810,nImproving Oral Health and Modulating the Oral Microbiome to Reduce Blood Stream Infections from Oral Organisms in Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients: A Randomized Controlled Trial.,"BACKGROUND Bloodstream infections (BSI) from oral organisms are a significant cause of morbidity and mortality in hematopoietic stem cell transplant (HSCT) recipients. There are no proven strategies to decrease BSI from oral organisms. The aim of this study was to evaluate the impact of daily xylitol wipes in improving oral health, decreasing BSI from oral organisms and modulating the oral microbiome in pediatric HSCT recipients. METHODS This was a single center 1:1 randomized controlled trial in pediatric HSCT recipients older than 2 years. Age matched healthy children were enrolled to compare the oral microbiome. The oral hygiene standard of care (SOC) group continued to receive the standard oral hygiene regimen. The xylitol group received daily oral xylitol wipes (with 0.7gm xylitol) in addition to the SOC. The intervention started from the beginning of the transplant chemotherapy regimen to 28 days following transplantation. The primary outcome was oral health at interval time points, and secondary outcomes included blood stream infections from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance. RESULTS The study was closed early due to efficacy after an interim analysis of the first 30 HSCT recipients was performed (SOC group (n=16) and xylitol group (n=14)). The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group. The xylitol group had no BSI from oral organisms compared to SOC group which had four (p=0.04). The xylitol group had significantly lower abundance of potential BSI pathogens such as Staphylococcus aureus (p=0.036), Klebsiella pneumoniae (p=0.033), and Streptococcus species (p=0.011) at day following transplantation compared to the SOC group. Healthy children and young adults had significantly increased oral microbiome diversity compared to all HSCT recipients (<0.001). CONCLUSIONS AND RELEVANCE The addition of xylitol to standard oral care significantly improves oral health, decreases BSI from oral organisms and decreases pathogenic oral organism abundance in pediatric and young adult HSCT recipients.",2020,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","['hematopoietic stem cell transplant (HSCT) recipients', 'Age matched healthy children', 'pediatric HSCT recipients older than 2 years', 'Healthy children and young adults', 'pediatric and young adult HSCT recipients', 'Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients', 'pediatric HSCT recipients']","['daily oral xylitol wipes (with 0.7gm xylitol', 'oral hygiene standard of care (SOC', 'xylitol']","['Klebsiella pneumoniae', 'oral health', 'oral ulcers', 'rate of gingivitis', 'oral microbiome diversity', 'abundance of potential BSI pathogens such as Staphylococcus aureus', 'oral plaque', 'oral health at interval time points, and secondary outcomes included blood stream infections from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance', 'pathogenic oral organism abundance']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",30.0,0.10366,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Badia', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center; Department of Pediatrics, University of Cincinnati College of Medicine; Department of Hematology and Oncology, Phoenix Children's Hospital. Electronic address: pbadia@phoenixchildrens.com.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haslam', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'S Nelson', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Pate', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Golkari', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Teusink-Cross', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flesch', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Ashely', 'Initials': 'A', 'LastName': 'Bedel', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hickey', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Kramer', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'M Davies', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center; Department of Pediatrics, University of Cincinnati College of Medicine.""}, {'ForeName': 'Sarat', 'Initials': 'S', 'LastName': 'Thikkurissy', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'E Dandoy', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center; Department of Pediatrics, University of Cincinnati College of Medicine.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.019'] 2265,32505857,Impact of Retained Cystoscopy Fluid Following Laparoscopic Hysterectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE To investigate the impact of retained cystoscopy fluid following laparoscopic hysterectomy on time to spontaneous void, time to discharge, urinary retention, bladder discomfort, and patient satisfaction. DESIGN Single-blind, randomized controlled trial SETTING: An academic medical center PATIENTS: One hundred and twenty patients who underwent laparoscopic hysterectomy with universal cystoscopy for benign indications, excluding pelvic organ prolapse and urinary incontinence indications. INTERVENTION From October 2018 to October 2019 we compared 200-mL retained cystoscopy fluid versus complete bladder emptying following laparoscopic hysterectomy with universal cystoscopy. MEASUREMENTS AND MAIN RESULTS A total of 120 patients were enrolled and randomized (59 in the retained cystoscopy fluid group, 61 in the emptied fluid group). The primary outcome was time to first spontaneous void. Secondary outcomes were time to discharge, urinary retention rates, bladder discomfort, and patient satisfaction. A sample size of 120 was calculated to detect a 57 minute difference in time to spontaneous void. There were minimal differences in baseline demographics and surgery characteristics between the groups. There was an apparent although not significant difference in time to void of 25 minutes (143 minutes versus 168 minutes, p = .20). Time to discharge and urinary retention rate did not differ (199 minutes versus 214 minutes, p = .40 and 13.6% versus 8.2%, p = .51). There was no difference in postoperative bladder discomfort and patient satisfaction. CONCLUSION Retained cystoscopy fluid following laparoscopic hysterectomy did not significantly impact time to first spontaneous void, time to discharge, urinary retention, bladder discomfort, or patient satisfaction.",2020,"Time to discharge and urinary retention rate did not differ (199 minutes versus 214 minutes, p = .40 and 13.6% versus 8.2%, p = .51).","['120 patients were enrolled and randomized (59 in the retained cystoscopy fluid group, 61 in the emptied fluid group', 'One hundred and twenty patients who underwent']","['Retained Cystoscopy Fluid Following Laparoscopic Hysterectomy', 'laparoscopic hysterectomy', 'laparoscopic hysterectomy with universal cystoscopy']","['time to spontaneous void, time to discharge, urinary retention, bladder discomfort, and patient satisfaction', 'postoperative bladder discomfort and patient satisfaction', 'time to discharge, urinary retention rates, bladder discomfort, and patient satisfaction', 'time to first spontaneous void', 'Time to discharge and urinary retention rate', 'baseline demographics and surgery characteristics', 'impact time to first spontaneous void, time to discharge, urinary retention, bladder discomfort, or patient satisfaction']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",120.0,0.560774,"Time to discharge and urinary retention rate did not differ (199 minutes versus 214 minutes, p = .40 and 13.6% versus 8.2%, p = .51).","[{'ForeName': 'Rachael B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery University of Arizona College of Medicine - Phoenix, Banner University Medical Center - Phoenixm 1111 East McDowell Road, Phoenix, AZ 85006. Electronic address: rachaelsmith.DO@gmail.com.'}, {'ForeName': 'Nichole D', 'Initials': 'ND', 'LastName': 'Mahnert', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery University of Arizona College of Medicine - Phoenix, Banner University Medical Center - Phoenixm 1111 East McDowell Road, Phoenix, AZ 85006. Electronic address: nichole.mahnert@gmail.com.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, 1295 N Martin Ave, Tucson, AZ 85724. Electronic address: hucc@arizona.edu.'}, {'ForeName': 'Kayvahn', 'Initials': 'K', 'LastName': 'Steck-Bayat', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery University of Arizona College of Medicine - Phoenix, Banner University Medical Center - Phoenixm 1111 East McDowell Road, Phoenix, AZ 85006. Electronic address: kayvahn@gmail.com.'}, {'ForeName': 'Ashley S', 'Initials': 'AS', 'LastName': 'Womack', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery University of Arizona College of Medicine - Phoenix, Banner University Medical Center - Phoenixm 1111 East McDowell Road, Phoenix, AZ 85006. Electronic address: awomackmd@gmail.com.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Mourad', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery University of Arizona College of Medicine - Phoenix, Banner University Medical Center - Phoenixm 1111 East McDowell Road, Phoenix, AZ 85006. Electronic address: swwcjm@mac.com.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.05.024'] 2266,32506083,Efficacy of Intra-peritoneal Tramadol Instillation for Postoperative Pain Management after Laparoscopic Cholecystectomy.,"Gall stone disease is one of the most common conditions encountered in general surgical practices in adult population. The gold standard treatment for symptomatic gall stone disease is laparoscopic cholecystectomy. It results in less post-operative pain as compared to open cholecystectomy but post-operative pain may be mild, moderate or even severe in some patients. This Randomized control trail was conducted to In-patient department of Surgery, Mymensingh Medical College & Hospital (MMCH), Mymensingh, Bangladesh from April 2018 to September 2018. It was undertaken to evaluate the analgesic effect of intra-peritoneal tramadol instillation in patients undergoing laparoscopic cholecystectomy. Total 70 patients with symptomatic gallstone disease undergoing laparoscopic cholecystectomy were randomized equally in two groups. Then patients were selected in according to the inclusion and exclusion criteria. In first group (Group A), patients were received intra-peritoneal tramadol 100mg (diluted in 20.0ml distilled water). Sprayed 10.0ml diluted tramadol into the sub diaphragmatic area, 5.0ml into the area of gall bladder bed and 5.0ml into the space between the liver and kidney under direct vision just before removal of trocars. In second group (Group B) the conventional operative procedure was followed. Postoperatively, patient was extubated and shifted to recovery room. Data recorded and analyzed, such as post-operative pain score at 1, 4, 8, and 24 hour; cumulative 1, 8 and 24 hour analgesic consumption. In addition that postoperative hospital period monitoring of heart rate, blood pressure, respiratory rate, temperature at 0, 4, 8, 24 hours was also analyzed. Intensity of pain was assessed by Visual Analogue Scale (VAS) scoring system. Patients showed a VAS ≥3 or patients who requested for analgesia was administrated a supplemental dose of analgesic. In the present study the mean pain scores in Group A were found to be low at1hourpost-operative was 0.60±0.56 and there was a gradual increase in score in respect of time interval with peak of 2.07±0.91 at 24 hours. Whereas, in Group B the mean pain scores immediate post-operative period were at its peak was, 2.50±0.82 which decreased to 1.30±0.84 at 1 hour and further there was rise at 4 hours (2.10±0.71) and 24 hours (2.33±0.0.71). But at any point of time the mean VAS remained significantly low (p<0.050) in patients with Group A compared to Group B except at 1st 24 hours (p=0.210). Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.",2020,Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.,"['patient department of Surgery, Mymensingh Medical College & Hospital (MMCH), Mymensingh, Bangladesh from April 2018 to September 2018', 'Postoperative Pain Management after Laparoscopic Cholecystectomy', 'patients undergoing laparoscopic cholecystectomy', 'Total 70 patients with symptomatic gallstone disease undergoing', 'laparoscopic cholecystectomy']","['Sprayed 10.0ml diluted tramadol', 'intra-peritoneal tramadol 100mg (diluted in 20.0ml distilled water', 'laparoscopic cholecystectomy', 'tramadol', 'Intra-peritoneal Tramadol Instillation', 'intra-peritoneal tramadol instillation']","['mean VAS', 'Intensity of pain', 'mean pain scores', 'mean pain scores immediate post-operative period', 'Visual Analogue Scale (VAS) scoring system', 'postoperative pain relief', 'heart rate, blood pressure, respiratory rate, temperature']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",70.0,0.025355,Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reza', 'Affiliation': 'Dr Ehsanur Reza, Associate Professor, Department of Surgery, Mymensingh Medical College (MMC), Mymensingh, Bangladesh.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bhuiyan', 'Affiliation': ''}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Emon', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Biplob', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kader', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Chaudary', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hasan', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Nisa', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[] 2267,32506088,Effect of Intravenous Paracetamol with Bupivacaine Scalp Nerve Block on Haemodynamics Response as Well as Anaesthetic Requirements during Supratentorial Craniotomies.,"Noxious stimuli during craniotomy may encourage hypertension and tachycardia, which may rise to morbidity in patients with intracranial hypertension. After craniotomy a moderate level of postoperative pain observed. The objective of this study was to observe the effect of intravenous paracetamol with bupivacaine scalp nerve block (SNB) on haemodynamics response as well as anaesthetic & analgesic requirements during supratentorial craniotomies. This is a single-blind, placebo-controlled, randomized clinical trial carried out in the Neurosurgery operation theatre from August 2015 to July 2017 under supervision of Department of Anaesthesia, Analgesia and Intensive Care Medicine of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. A total of 40 patients aged 18-60 years with supratentorial space occupying lesion undergoing craniotomy under general anaesthesia who were attended in the department of Neurosurgery, BSMMU were enrolled in this study and they were divided randomly into two groups, 20 patients in each. The Group A received 100ml normal saline infusion and 0.25% bupivacaine (20ml) in scalp block, while the Group B received intravenous injection paracetamol (1gm) and 0.25% bupivacaine (total 20ml) in scalp block. Statistical analyses were obtained Statistical Packages for Social Sciences (SPSS-22). The mean systolic blood pressure varied within the normal range in both groups. The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision. However, mean MAP of Group B remained significantly lower than that of Group A in different time interval. The mean heart rate of Group B remained significantly lower than that of Group A. The mean intraoperative propofol as well as fentanyl requirements were significantly decreased in Group B in comparison to Group A. The combination of intravenous paracetamol with bupivacaine scalp nerve block provides better intra-operative haemodynamic stability and neurosurgical compliances for the patients undergoing supratentorial craniotomies under general anaesthesia.",2020,The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision.,"['patients undergoing supratentorial craniotomies under general anaesthesia', '40 patients aged 18-60 years with supratentorial space occupying lesion undergoing craniotomy under general anaesthesia who were attended in the department of Neurosurgery, BSMMU were enrolled in this study and they were divided randomly into two groups, 20 patients in each', 'Neurosurgery operation theatre from August 2015 to July 2017 under supervision of Department of Anaesthesia, Analgesia and Intensive Care Medicine of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'supratentorial craniotomies', 'Supratentorial Craniotomies', 'patients with intracranial hypertension']","['Intravenous Paracetamol', 'bupivacaine scalp nerve block', 'bupivacaine scalp nerve block (SNB', 'paracetamol', 'intravenous injection paracetamol (1gm) and 0.25% bupivacaine (total 20ml) in scalp block', '100ml normal saline infusion and 0.25% bupivacaine (20ml) in scalp block', 'Bupivacaine Scalp Nerve Block', 'placebo']","['mean systolic blood pressure', 'fentanyl requirements', 'mean DBP', 'Haemodynamics Response', 'mean intraoperative propofol', 'mean heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",40.0,0.0442747,The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Kamal', 'Affiliation': 'Dr Md Mustafa Kamal, Associate Professor, Department of Anaesthesia, Analgesia and Intensive Care Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh; E-mail: kamalanaes64@gmail.com.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'Chowdhury', 'Affiliation': ''}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Islam', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hossain', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Akhtaruzzaman', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[] 2268,32506089,Efficacy of Itraconazole in the Prevention of Recurrence of Tinea Versicolor: A Three Year Follow Up.,"Pityriasis versicolor (PV) also known as tinea versicolor, which is chronic and superficial fungal skin disease caused by Malassezia yeasts. A permanent cure may difficult to achieve and this may explain the long-term nature of the disease. Consequently, a preventive treatment regimen may help to prevent the recurrence of pityriasis versicolor. Whether, the recurrence of tinea versicolor could be prevented by monthly itraconazole treatment regimen after a short course of itraconazole therapy. Open treatment followed by a randomized, single blind placebo control trial. Multi-center trial was characterized by an open, active treatment phase with itraconazole followed by a randomized placebo controlled treatment for prevention of recurrence. A total 200 patients (150 male and 50 female) were included in this study and was given 200mg itraconazole daily for 7 days (treatment phase). Patients in whom tinea versicolor was mycologically cured divided into Group A and Group B. Active open treatment was followed by preventive itraconazole treatment 200mg twice daily in Group A and placebo in Group B monthly for 6 consecutive months. The patients were diagnosed clinically and confirmed by Wood's lamp examination and KOH microscopy. Clinical improvement in 90%, negative Wood's lamp examination in 86.5% and Mycological cure in 85.5% were found at the end of open treatment. The mycological cure, 171 subjects were taken into this study for preventive treatment phase and divided into two groups- Group A & Group B. Preventive treatment was given in Group A and placebo in Group B. After the preventive treatment, the end point (After 6 months), clinical improvement, negative Wood's lamp examination and mycological cure were found in 81(90%), 76(84.4%) and 75(83.3%) in Group A and 44(55%), 41(51.3%) and 42(52.5%) in Group B respectively. In preventive treatment phase, 1 patient in Group A did not complete the study. No patient experienced any serious adverse effects. Prevention of recurrence of Pityriasis versicolor with itraconazole is as effective as treatment.",2020,No patient experienced any serious adverse effects.,"['A total 200 patients (150 male and 50 female', ""patients were diagnosed clinically and confirmed by Wood's lamp examination and KOH microscopy"", 'Patients in whom tinea versicolor', '171 subjects', 'Tinea Versicolor']","['itraconazole', 'Itraconazole', 'itraconazole treatment 200mg twice daily in Group A and placebo', 'itraconazole therapy', 'groups- Group A & Group B. Preventive treatment was given in Group A and placebo', 'placebo']","[""clinical improvement, negative Wood's lamp examination and mycological cure"", ""negative Wood's lamp examination"", 'recurrence of pityriasis versicolor', 'Mycological cure', 'serious adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0040262', 'cui_str': 'Pityriasis versicolor'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040262', 'cui_str': 'Pityriasis versicolor'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",200.0,0.0235956,No patient experienced any serious adverse effects.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Wahab', 'Affiliation': 'Professor Lt Col Md Abdul Wahab, Professor, Department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh; E-mail: wahab_skinvd@yahoo.com.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kamal', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Shahin', 'Affiliation': ''}, {'ForeName': 'R U', 'Initials': 'RU', 'LastName': 'Siddique', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Hassan', 'Affiliation': ''}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Hassan', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Haque', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Nandi', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[] 2269,32515067,Compassion Focused Therapy for Body Weight Shame: A Mixed Methods Pilot Trial.,"Individuals with bigger bodies (Body Mass Index > 30) often experience body weight shame, and are at increased risk for mental health vulnerabilities such as depression and anxiety. To date, there have been no studies specifically designed and pilot tested to help with body weight shame for individuals with bigger bodies that do not have a diagnosed clinical condition. The aim of current study is to investigate the initial feasibility of Compassion Focused Therapy (CFT) as a 12-session group intervention for the reduction in body weight shame for individuals with bigger bodies. The study used a mixed methods repeated measures design, with both quantitative and qualitative measures, to assess the initial feasibility of the CFT group based intervention. Participants (N = 5) attended a 12-session/2-hour group CFT program aimed to directly target body weight shame by cultivating compassion. Measurements were conducted at three time points (pre-, post-, and three-month follow-up intervention). Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion, and improving health engaging behaviors. Qualitative feedback indicated the importance of the group dynamics to help with the de-shaming of body appearance for individuals. Results from this feasibility trial are promising and future research using randomized controlled trial methodologies should be conducted to evaluate the effectiveness of CFT as a treatment option for body weight shame for individuals with bigger bodies.",2020,"Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion, and improving health engaging behaviors.","['Individuals with bigger bodies (Body Mass Index > 30) often experience body weight shame', 'individuals with bigger bodies', 'Body Weight Shame']","['CFT', 'Compassion Focused Therapy (CFT', '12-session/2-hour group CFT program']","['body weight shame', 'body weight shame, increasing compassion, and improving health engaging behaviors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036938', 'cui_str': 'Shame'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0357485,"Results indicated that CFT had a positive impact on reducing body weight shame, increasing compassion, and improving health engaging behaviors.","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': 'University of Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gilbert', 'Affiliation': 'Derby University, United Kingdom.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Kirby', 'Affiliation': 'University of Queensland, Australia.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2488'] 2270,32515099,Alcohol use and injury risk in Thailand: A case-crossover emergency department study.,"INTRODUCTION AND AIMS While injuries and alcohol contribute to a large proportion of the disease burden in Thailand, no well-designed underlying study has yet been published. This study aims to evaluate the relationship between acute alcohol consumption and injury risk in Thailand. DESIGN AND METHODS Using the case-crossover design, this study examined 520 injured patients aged 18 years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016. The case period was defined as 6 h prior to injury, the two control periods as the same 6-h period at 1 day and 7 days prior to injury. Alcohol exposure and the amount consumed were measured for these periods. RESULTS Twenty percent of injured patients consumed alcohol within the 6 h prior to injury, averaging 6.9 drinks during that time. The odds of injury for those individuals consuming alcoholic beverages was 5.0 (95% confidence interval 3.0, 8.2) times greater compared to non-exposure individuals; every additional drink consumed increased the odds of injury by 1.3 (95% confidence interval 1.2, 1.4). Alcohol use significantly increased the odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury (among drivers). The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers). DISCUSSION AND CONCLUSIONS Exposure to alcohol increased the odds of injury in a dose-dependent fashion; hence, comprehensive, cost-effective strategies should be implemented in Thailand to reduce alcohol exposure, binge drinking and drunk driving.",2020,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers). ","['520 injured patients aged 18\u2009years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016', 'Thailand']",[],"['risks of unintentional injury and road traffic injuries', 'odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0151737', 'cui_str': 'Intentional injury'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",520.0,0.0189327,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers). ","[{'ForeName': 'Bundit', 'Initials': 'B', 'LastName': 'Sornpaisarn', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Sarnti', 'Initials': 'S', 'LastName': 'Sornpaisarn', 'Affiliation': 'Faculty of Health Science, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Shield', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Drug and alcohol review,['10.1111/dar.13094'] 2271,32515119,"The effect of preoperative pentoxifylline on postoperative pain and development of secondary hyperalgesia in patients undergoing laparoscopic appendectomy; a randomized, double-blind, placebo-controlled trial study.","BACKGROUND After surgery and loss of anesthetic effect, postoperative pain can annoy the patient and affect patient satisfaction with treatment. This study was aimed at evaluating the effect of preoperative pentoxifylline (PTX) on postoperative pain and development of secondary hyperalgesia in patients undergoing laparoscopic appendectomy (LA). METHODS This randomized, double-blind, placebo-controlled clinical trial study was conducted on 91 eligible subjects with acute appendicitis referred to Shahid Beheshti hospital of Sabzevar, Iran in 2018. The intervention and control groups were administered with a single oral dose of PTX (10 mg kg-1) and placebo an hour before surgery respectively. Postoperative pain was measured within 24 hours after surgery using a Visual Analog Score (VAS) and the area of secondary hyperalgesia was measured 24 hours after surgery using Stubhaug et al. method. RESULTS The mean age of the subjects was 26.74±9.99 and 57.14% were female. Pain intensity during rest was significantly greater in the control group as compared to PTX at 24 th hours after surgery (2.19±0.49 and 3.13±0.66; P <0.001 respectively). Moreover, pain intensity during cough was substantially lower in the PTX compared with the control group at 24 th hours after surgery (2.65±1.90 and 4.10±2.60; P = 0.003 in turn). The dynamic hyperalgesia was significantly greater in the control group as compared with the PTX group (3.80±1.82 and 7.43 ±2.38; P <0.001). CONCLUSIONS Findings suggest that oral administration of PTX one hour before surgery in patients undergoing LA can reduce postoperative pain in patients and prevent secondary hyperalgesia at a surgical site.",2020,"Moreover, pain intensity during cough was substantially lower in the PTX compared with the control group at 24 th hours after surgery (2.65±1.90 and 4.10±2.60; P = 0.003 in turn).","['patients undergoing laparoscopic appendectomy (LA', 'mean age of the subjects was 26.74±9.99 and 57.14% were female', '91 eligible subjects with acute appendicitis referred to Shahid Beheshti hospital of Sabzevar, Iran in 2018', 'patients undergoing laparoscopic appendectomy']","['PTX', 'preoperative pentoxifylline', 'preoperative pentoxifylline (PTX', 'placebo']","['pain intensity during cough', 'postoperative pain and development of secondary hyperalgesia', 'postoperative pain', 'Pain intensity', 'dynamic hyperalgesia', 'Visual Analog Score (VAS) and the area of secondary hyperalgesia', 'Postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",91.0,0.557522,"Moreover, pain intensity during cough was substantially lower in the PTX compared with the control group at 24 th hours after surgery (2.65±1.90 and 4.10±2.60; P = 0.003 in turn).","[{'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Nazemi', 'Affiliation': 'Physiologist, Cellular and Molecular Research Center, Department of Physiology and Pharmacology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Taherian', 'Affiliation': 'MSc in Nursing, Department of Nursing, School of Nursing, Islamic Azad University, Kashmar Branch, Kashmar, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': 'General Surgeon, Department of Surgery and Orthopedics, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': 'MSc in Epidemiology, Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Jafarpour', 'Affiliation': 'General Practitioner, Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Abdolalizadeh', 'Affiliation': 'General Practitioner, Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'MSc in Epidemiology, Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12925'] 2272,32515124,Comparison of life-behavior-promoting mobilization care with walking-only mobilization care in post-gastrointestinal surgery patients: A quasi-experimental study.,"AIM This study evaluated the effects of a new form of mobilization care called life-behavior-promotion care by comparing its effectiveness with that of conventional mobilization care, which promotes only walking. METHODS This was a quasi-experimental study that non-randomly allocated post-gastrointestinal surgery patients from a surgical ward into two groups: conventional care and life-behavior-promotion care. The participants received their respective care from ward nurses for the first 3 postoperative days and were asked to wear a pedometer and answer a self-administered questionnaire concerning these first 3 days. In addition, time to recover gastrointestinal function, time to completion of oxygen administration, and the number of days to achieve discharge criteria were collected from medical records. RESULTS Overall, 23 participants in the conventional-care group and 19 in the life-behavior-promotion-care group were analyzed. The latter group performed significantly more types of out-of-bed life behaviors during the 3 postoperative days. Among the questionnaire items concerning awareness of recovery, an interaction between intervention and length of postoperative days was confirmed for items reading ""I was interested in surrounding events"" and ""I could spend a day like myself."" In addition, in the life-behavior-promotion-care group, time to completion of oxygen administration was significantly shorter, and it took fewer days to achieve discharge criteria. CONCLUSIONS The results of this study suggest that life-behavior-promotion care may promote out-of-bed life behaviors during the early postoperative period, and may improve mental and physical recovery in patients who have undergone gastrointestinal surgery. CLINICAL TRIAL REGISTRATION The study was registered in the UMIN Clinical Trials Registry (trial ID: UMIN000021883).",2020,"In addition, in the life-behavior-promotion-care group, time to completion of oxygen administration was significantly shorter, and it took fewer days to achieve discharge criteria. ","['post-gastrointestinal surgery patients', 'patients who have undergone gastrointestinal surgery', '23 participants in the conventional-care group and 19 in the life-behavior-promotion-care group were analyzed', 'non-randomly allocated post-gastrointestinal surgery patients from a surgical ward into two groups']","['life-behavior-promoting mobilization care with walking-only mobilization care', 'conventional care and life-behavior-promotion care']","['types of out-of-bed life behaviors', 'time to recover gastrointestinal function, time to completion of oxygen administration, and the number of days to achieve discharge criteria', 'time to completion of oxygen administration']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",23.0,0.0673131,"In addition, in the life-behavior-promotion-care group, time to completion of oxygen administration was significantly shorter, and it took fewer days to achieve discharge criteria. ","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Katogi', 'Affiliation': 'School of Nursing, Faculty of Health and Social Services, Kanagawa University of Human Services, Kanagawa, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12348'] 2273,32515134,"Effectiveness of Natural Frequency Technology ® on cognition, sleep, and mood of adults with high perceived stress: A randomized, double-blind, placebo-controlled crossover study.","INTRODUCTION NexQuest Natural Frequency Technology ® (NFT ® ), intended to enhance biological function using naturally occurring frequencies, may be a nonpharmacological intervention to improve stress and health. The study purpose was to determine the effectiveness of NFT ® for improving stress, sleep quality, mood, and cognition in adults. METHODS Using a double-blind placebo-controlled crossover design, participants with high perceived stress (N = 42, M age = 43.8) were assessed at baseline (BL) and assigned to either the Placebo Watch (PW) or Wellness Watch (WW) condition for 2 weeks, and then 2 weeks in the alternate condition. Participants completed the following self-report surveys of Perceived Stress Scale, Pittsburgh Sleep Quality Index, Insomnia Severity Index, Food Craving Questionnaire, and Profile of Mood States, as well as the CNS Vital Signs neurocognitive test at BL and following each condition. RESULTS The WW condition had significant improvements in sleep duration and Complex Attention compared to the PW group. Compared to BL, both conditions had significant improvements for perceived stress, food cravings, mood, sleep quality, and several cognitive tests, p's < .05. CONCLUSION Despite the placebo effect, NFT ® may be a natural alterative for improving stress and health. Research is needed examining the efficacy of NFT ® in a variety of populations and environments.",2020,"Compared to BL, both conditions had significant improvements for perceived stress, food cravings, mood, sleep quality, and several cognitive tests, p's < .05. ","['in adults', 'adults with high perceived stress', 'participants with high perceived stress (N\xa0=\xa042, M age\xa0=\xa043.8']","['Placebo Watch (PW) or Wellness Watch (WW) condition', 'Natural Frequency Technology ®', 'NFT ®', 'placebo']","['Perceived Stress Scale, Pittsburgh Sleep Quality Index, Insomnia Severity Index, Food Craving Questionnaire, and Profile of Mood States, as well as the CNS Vital Signs neurocognitive test', 'sleep duration and Complex Attention', 'perceived stress, food cravings, mood, sleep quality, and several cognitive tests', 'stress, sleep quality, mood, and cognition', 'cognition, sleep, and mood']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085400', 'cui_str': 'Neurofibrillary degeneration'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.209476,"Compared to BL, both conditions had significant improvements for perceived stress, food cravings, mood, sleep quality, and several cognitive tests, p's < .05. ","[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Hausenblas', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, FL, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hooper', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, FL, USA.'}, {'ForeName': 'Ashlyn', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Center for Health and Human Performance, Jacksonville University, Jacksonville, FL, USA.'}]",Brain and behavior,['10.1002/brb3.1712'] 2274,32515156,A 12-month pilot study outcomes of vagus nerve stimulation in Crohn's disease.,"BACKGROUND The vagus nerve has anti-inflammatory properties. We aimed to investigate vagus nerve stimulation (VNS) as a new therapeutic strategy targeting an intrinsic anti-inflammatory pathway in a pilot study in Crohn's disease patients. The main objectives addressed the questions of long-term safety, tolerability, and anti-inflammatory effects of this therapy. This study is the continuation of previous reported findings at 6 months. METHODS Nine patients with moderate active disease underwent VNS. An electrode wrapped around the left cervical vagus nerve was continuously stimulated over 1 year. Clinical, biological, endoscopic parameters, cytokines (plasma, gut), and mucosal metabolites were followed-up. KEY RESULTS After 1 year of VNS, five patients were in clinical remission and six in endoscopic remission. C-reactive protein (CRP) and fecal calprotectin decreased in six and five patients, respectively. Seven patients restored their vagal tone and decreased their digestive pain score. The patients' cytokinergic profile evolved toward a more ""healthy profile"": Interleukins 6, 23, 12, tumor necrosis factor α, and transforming growth factorβ1 were the most impacted cytokines. Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate. VNS was well tolerated. CONCLUSION & INFERENCES Vagus nerve stimulation appears as an innovative and well-tolerated treatment in moderate Crohn's disease. After 12 months, VNS has restored a homeostatic vagal tone and reduced the inflammatory state of the patients. VNS has probably a global modulatory effect on the immune system along with gut metabolic regulations. This pilot study needs replication in a larger randomized double-blinded control study.",2020,"Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate.","['patients\' cytokinergic profile evolved toward a more ""healthy profile', ""Crohn's disease patients"", ""Crohn's disease"", 'Nine patients with moderate active disease underwent VNS']","['vagus nerve stimulation', 'vagus nerve stimulation (VNS']","['vagal tone', 'clinical remission and six in endoscopic remission', 'tolerated', 'CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate', 'C-reactive protein (CRP) and fecal calprotectin', 'digestive pain score', 'tumor necrosis factor α, and transforming growth factorβ1', 'homeostatic vagal tone', 'Clinical, biological, endoscopic parameters, cytokines (plasma, gut), and mucosal metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",5.0,0.0874017,"Correlations were observed between CRP and tumor necrosis factor α, and some gut mucosa metabolites as taurine, lactate, alanine, and beta-hydroxybutyrate.","[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Sinniger', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pellissier', 'Affiliation': 'University of Grenoble Alpes, University of Savoie Mont Blanc and LIP/PC2S, Grenoble, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Fauvelle', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Trocmé', 'Affiliation': 'BEP Laboratory Building, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hoffmann', 'Affiliation': 'Neurosurgery Department, Grenoble Alpes Hospital, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vercueil', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Cracowski', 'Affiliation': 'INSERM CIC1406, University of Grenoble Alpes Hospital, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'David', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bonaz', 'Affiliation': 'Inserm, U1216, Grenoble Institute Neurosciences, University of Grenoble Alpes, Grenoble, France.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13911'] 2275,32515245,"Feasibility, acceptability, and preliminary impact of telemedicine-administered cognitive behavioral therapy for adherence and depression among African American women living with HIV in the rural South.",Women living with HIV are disproportionally affected by depression and mental healthcare access. A pilot feasibility trial using videoconferencing compared cognitive behavioral therapy for antiretroviral therapy adherence and depression ( N  = 11) to supportive psychotherapy ( N  = 11). Participants completed 10-12 weekly therapy sessions and 6-month follow-up. Retention at 6 months was 95 percent. Depression symptoms significantly decreased in both arms; antiretroviral therapy adherence remained high as measured via self-report and Wisepill. Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling. This study demonstrates the feasibility of telemedicine-administered psychotherapy addressing mental health needs among women living with HIV.,2020,Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling.,"['Women living with HIV', 'African American women living with HIV in the rural South', 'women living with HIV']","['videoconferencing compared cognitive behavioral therapy', 'telemedicine-administered cognitive behavioral therapy', 'supportive psychotherapy', 'telemedicine-administered psychotherapy']","['adherence and depression', 'Depression symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0794594,Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Junkins', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Psaros', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Corilyn', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Crystal Chapman', 'Initials': 'CC', 'LastName': 'Lambert', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cropsey', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Savage', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Mirjam-Colette', 'Initials': 'MC', 'LastName': 'Kempf', 'Affiliation': 'The University of Alabama at Birmingham, USA.'}]",Journal of health psychology,['10.1177/1359105320926526'] 2276,32515426,The Effect of CO2 Laser Irradiation Combined with TiF4 and NaF Varnishes on Enamel Hardness: An In Vitro Study.,"PURPOSE To assess the effects of experimental titanium tetrafluoride (TiF4) varnish and commercial sodium fluoride (NaF) varnish with CO2 laser on enamel hardness. MATERIALS AND METHODS Ninety human enamel samples were randomly assigned to one of the following groups: 1. control (no treatment) (CO); 2. NaF varnish (2.26%) (NF); 3. TiF4 varnish (2.45%) (TF); 4. CO2 laser (La); 5. NaF varnish (2.26%) with CO2 laser (NFL); 6. TiF4 varnish (2.45%) with CO2 laser (TFL). Enamel surface changes were determined by Vickers microhardness (VH) test with a load of 1000 g and a dwell time of 12 s. Each sample was indented three times. Data were analysed using one-way ANOVA and Tukey's test. RESULTS The mean surface microhardness was 245.5 VH in the CO group, 280.3 VH in group NF, 338.7 VH group TF, 277.0 VH in group La, 345.3 VH in group NFL, and 368.0 VH in group TFL. Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05). CONCLUSION The microhardness of enamel treated with TiF4 varnish with or without laser irradiation was statistically significantly greater than that of the control group. Thus, using TiF4 to increase enamel surface microhardness can be recommended.",2020,"Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05). ","['Enamel Hardness', 'Ninety human enamel samples']","['TiF4 varnish with or without laser irradiation', 'CO2 laser (La', 'NaF varnish', 'CO2 laser (NFL', 'TiF4 varnish', 'CO2 Laser Irradiation Combined with TiF4 and NaF Varnishes', 'CO', 'CO2 laser (TFL', 'control (no treatment', 'experimental titanium tetrafluoride (TiF4) varnish and commercial sodium fluoride (NaF) varnish with CO2 laser']",['surface hardness'],"[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0076741', 'cui_str': 'titanium tetrafluoride'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0194982,"Statistical analysis showed that groups TF, NFL, and TFL had statistically significantly higher surface hardness than the control group (p < 0.05). ","[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Dehghan', 'Affiliation': ''}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Mojarad', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Serajzadeh', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fekrazad', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44690'] 2277,32515543,Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials.,"Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM) and new generation basal insulins may improve patient outcomes. This post-hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomised, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1, and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomised to Gla-300 and Gla-100, HbA 1c reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than Gla-100 (9.3%). From baseline to Month 6, the risk of a first SH event was lower with Gla-300: hazard ratio, 0.65 (95% confidence interval [CI] 0.44-0.98; stratified log-rank test, P = 0.038). SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]). Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period. This article is protected by copyright. All rights reserved.",2020,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,['Participants with Type 1 Diabetes'],"['Glargine 100', 'SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL', 'Insulin Glargine']","['incidence and time to first occurrence of SH', 'Severe hypoglycaemia (SH', '≥1 SH event with Gla-300', 'risk of a first SH event', 'SH event rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0663423,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sussebach', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, PG, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14109'] 2278,32515694,Discrepancy between post-treatment infarct volume and 90-day outcome in the ESCAPE randomized controlled trial.,"BACKGROUND Some patients with ischemic stroke have poor outcomes despite small infarcts after endovascular thrombectomy, while others with large infarcts sometimes fare better. AIMS We explored factors associated with such discrepancies between post-treatment infarct volume (PIV) and functional outcome. METHODS We identified patients with small PIV (volume ≤ 25th percentile) and large PIV (volume ≥ 75th percentile) on 24-48-h CT/MRI in the ESCAPE randomized-controlled trial. Demographics, comorbidities, baseline, and 24-48-h stroke severity (NIHSS), stroke location, treatment type, post-stroke complications, and other outcome scales like Barthel Index, and EQ-5D were compared between ""discrepant cases"" - those with 90-day modified Rankin Scale(mRS) ≤ 2 despite large PIV or mRS ≥ 3 despite small PIV - and ""non-discrepant cases"". Multi-variable logistic regression was used to identify pre-treatment and post-treatment factors associated with small-PIV/mRS ≥ 3 and large-PIV/mRS ≤ 2. Sensitivity analyses used different definitions of small/large PIV and good/poor outcome. RESULTS Among 315 patients, median PIV was 21 mL; 27/79 (34.2%) patients with PIV ≤ 7 mL (25th percentile) had mRS ≥ 3; 12/80 (15.0%) with PIV ≥ 72 mL (75th percentile) had mRS ≤ 2. Discrepant cases did not differ by CT versus MRI-based PIV ascertainment, or right versus left-hemisphere involvement ( p  = 0.39, p  = 0.81, respectively, for PIV ≤ 7 mL/mRS ≥ 3). Pre-treatment factors independently associated with small-PIV/mRS ≥ 3 included older age ( p  = 0.010), cancer, and vascular risk-factors; post-treatment factors included 48-h NIHSS ( p  = 0.007) and post-stroke complications ( p  = 0.026). Absence of vascular risk-factors ( p  = 0.004), CT-based lentiform nucleus sparing ( p  = 0.002), lower 24-hour NIHSS ( p  = 0.001), and absence of complications ( p  = 0.013) were associated with large-PIV/mRS ≤ 2. Sensitivity analyses yielded similar results. CONCLUSIONS Discrepancies between functional ability and PIV are likely explained by differences in age, comorbidities, and post-stroke complications, emphasizing the need for high-quality post-thrombectomy stroke care. CLINICAL TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT01778335 .",2020,"treatment factors independently associated with small-PIV/mRS ≥ 3 included older age ( p  = 0.010), cancer, and vascular risk-factors; post-treatment factors included 48-h NIHSS ( p  = 0.007) and post-stroke complications ( p  = 0.026).","['patients with small PIV (volume\u2009≤\u200925th percentile) and large PIV (volume\u2009≥\u200975th percentile) on 24-48-h CT/MRI in the ESCAPE randomized-controlled trial', 'patients with ischemic stroke']",[],"['absence of complications', 'median PIV', 'Demographics, comorbidities, baseline, and 24-48-h stroke severity (NIHSS), stroke location, treatment type, post-stroke complications, and other outcome scales like Barthel Index, and EQ-5D', 'post-stroke complications', 'Absence of vascular risk-factors', 'lower 24-hour NIHSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",[],"[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}]",315.0,0.132678,"treatment factors independently associated with small-PIV/mRS ≥ 3 included older age ( p  = 0.010), cancer, and vascular risk-factors; post-treatment factors included 48-h NIHSS ( p  = 0.007) and post-stroke complications ( p  = 0.026).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Ganesh', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bijoy K', 'Initials': 'BK', 'LastName': 'Menon', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Zarina A', 'Initials': 'ZA', 'LastName': 'Assis', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Fahad S', 'Initials': 'FS', 'LastName': 'Al-Ajlan', 'Affiliation': 'Department of Neurosciences, King Faisal Specialist Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Al-Mekhlafi', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'Department of Radiology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Shuaib', 'Affiliation': 'Stroke Program and Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Blaise W', 'Initials': 'BW', 'LastName': 'Baxter', 'Affiliation': 'Department of Radiology, University of Tennessee, Erlanger Hospital, Knoxville, TN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Devlin', 'Affiliation': 'Department of Neurology, University of Tennessee, Erlanger Hospital, Knoxville, TN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Department of Neuroradiology, Beaumont Hospital and the Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'Department of Geriatric & Stroke Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Alexandre Y', 'Initials': 'AY', 'LastName': 'Poppe', 'Affiliation': ""Department of Neurosciences, Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Department of Radiology, CHUM, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Krings', 'Affiliation': 'Department of Medical Imaging, University Health Network, University of Toronto, Toronto Western Hospital, Toronto, Canada.'}, {'ForeName': 'Leanne K', 'Initials': 'LK', 'LastName': 'Casaubon', 'Affiliation': 'Division of Neurology, Stroke Program, University Health Network, University of Toronto, Toronto Western Hospital, Toronto, Canada.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Kashani', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Canada.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020929943'] 2279,32515696,"Effect of emergent carotid stenting during endovascular therapy for acute anterior circulation stroke patients with tandem occlusion: A multicenter, randomized, clinical trial (TITAN) protocol.","BACKGROUND AND HYPOTHESIS There is no consensus on the optimal endovascular management of the extracranial internal carotid artery steno-occlusive lesion in patients with acute ischemic stroke due to tandem occlusion. We hypothesized that intracranial mechanical thrombectomy plus emergent internal carotid artery stenting (and at least one antiplatelet therapy) is superior to intracranial mechanical thrombectomy alone in patients with acute tandem occlusion. STUDY DESIGN TITAN is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) study. Eligibility requires a diagnosis of acute ischemic stroke, pre-stroke modified Rankin Scale (mRS)≤2 (no upper age limit), National Institutes of Health Stroke Scale (NIHSS)≥6, Alberta Stroke Program Early Computed Tomography Score (ASPECTS)≥6, and tandem occlusion on the initial catheter angiogram. Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion. Patients are randomized in two balanced parallel groups (1:1) to receive either intracranial mechanical thrombectomy plus internal carotid artery stenting (and at least one antiplatelet therapy) or intracranial mechanical thrombectomy alone within 8 h of stroke onset. Up to 432 patients are randomized after tandem occlusion confirmation on angiogram. STUDY OUTCOMES The primary outcome measure is complete reperfusion rate at the end of endovascular procedure, assessed as a modified Thrombolysis in Cerebral Infarction (mTICI) 3, and ≥4 point decrease in NIHSS at 24 h. Secondary outcomes include infarct growth, recurrent clinical ischemic event in the ipsilateral carotid territory, type and dose of antiplatelet therapy used, mRS at 90 (±15) days and 12 (±1) months. Safety outcomes are procedural complications, stent patency, intracerebral hemorrhage, and death. Economics analysis includes health-related quality of life, and costs utility comparison, especially with the need or not of endarterectomy. DISCUSSION TITAN is the first randomized trial directly comparing two types of treatment in patients with acute ischemic stroke due to anterior circulation tandem occlusion, and especially assessing the safety and efficacy of emergent internal carotid artery stenting associated with at least one antiplatelet therapy in the acute phase of stroke reperfusion. TRIAL REGISTRATION ClinicalTrials.gov NCT03978988.",2020,"Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion.","['432 patients', 'patients with acute ischemic stroke due to anterior circulation tandem occlusion', 'patients with acute tandem occlusion', 'patients with acute ischemic stroke due to tandem occlusion', 'acute anterior circulation stroke patients with tandem occlusion']","['endovascular therapy', 'intracranial mechanical thrombectomy plus emergent internal carotid artery stenting (and at least one antiplatelet therapy', 'intracranial mechanical thrombectomy plus internal carotid artery stenting (and at least one antiplatelet therapy) or intracranial mechanical thrombectomy alone', 'emergent carotid stenting']","['complete reperfusion rate at the end of endovascular procedure, assessed as a modified Thrombolysis in Cerebral Infarction (mTICI) 3, and ≥4 point decrease in NIHSS', 'procedural complications, stent patency, intracerebral hemorrhage, and death', 'infarct growth, recurrent clinical ischemic event in the ipsilateral carotid territory, type and dose of antiplatelet therapy used, mRS at 90 (±15) days and 12 (±1) months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C2936204', 'cui_str': 'Intravascular Techniques'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.118466,"Tandem occlusion is defined as large vessel occlusion (intracranial internal carotid artery , M1 and/or M2 segment) and extracranial severe internal carotid artery stenosis ≥90% (NASCET) or complete occlusion.","[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Hossu', 'Affiliation': 'CIC 1433, Technological Innovation, IADI, INSERM U1254, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Soudant', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Richard', 'Affiliation': 'CIC 1433 Plurithematic, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Achit', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Beguinet', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Department of Interventional Neuroradiology, CHRU Gui de Chauliac, Montpellier, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Arquizan', 'Affiliation': 'Department of Neurology, CHRU Gui de Chauliac, Montpellier, France.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Neurology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Rouchaud', 'Affiliation': 'Department of Interventional Neuroradiology, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Macian-Montoro', 'Affiliation': 'Department of Neurology, CHU Dupuytren, Limoges, France.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Neuroradiology and Endovascular Therapy, Besançon University Hospital, Besancon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Moulin', 'Affiliation': 'Department of Neurology, Besançon University Hospital, Besancon, France.'}, {'ForeName': 'Gaultier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Department of Neuroradiology, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sibon', 'Affiliation': 'Department of Neurology, Stroke Center, University Hospital of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Paya', 'Affiliation': 'Department of Neuroradiology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Vannier', 'Affiliation': 'Department of Neurology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cognard', 'Affiliation': 'Department of Neuroradiology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Viguier', 'Affiliation': 'Department of Neurology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Department of Neurology, Stroke Unit, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Wagih B', 'Initials': 'WB', 'LastName': 'Hassen', 'Affiliation': 'Department of Neuroradiology, Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Turc', 'Affiliation': 'Department of Neurology, Stroke Unit, Saint-Anne Hospital, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Clarençon', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': 'Department of Neurology, Stroke Unit, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dumas-Duport', 'Affiliation': 'Department of Neuroradiology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Preterre', 'Affiliation': 'Department of Neurology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Barbier', 'Affiliation': 'Department of Neuroradiology, Caen University Hospital, Caen, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Boulanger', 'Affiliation': 'Department of Neurology, Caen University Hospital, Caen, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Janot', 'Affiliation': 'Department of Neuroradiology, Tours University Hospital, Lille, France.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Annan', 'Affiliation': 'Department of Neurology, Tours University Hospital, Lille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bricout', 'Affiliation': 'Department of Neuroradiology, Lille University Hospital, Lille, France.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Henon', 'Affiliation': 'Department of Neurology, Lille University Hospital, Lille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Soize', 'Affiliation': 'Department of Neuroradiology, Reims University Hospital, Lille, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Moulin', 'Affiliation': 'Department of Neurology, Reims University Hospital, Lille, France.'}, {'ForeName': 'Marc-Antoine', 'Initials': 'MA', 'LastName': 'Labeyrie', 'Affiliation': 'Department of Neuroradiology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Reiner', 'Affiliation': 'Department of Neurology, Lariboisière Hospital, Paris, France.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Pop', 'Affiliation': 'Department of Neuroradiology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Wolff', 'Affiliation': 'Department of Neurology, Stroke Unit, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Ognard', 'Affiliation': 'Department of Neuroradiology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Timsit', 'Affiliation': 'Department of Neurology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Reyre', 'Affiliation': 'Department of Neuroradiology, Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Perot', 'Affiliation': 'Department of Neurology, Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Papagiannaki', 'Affiliation': 'Department of Neuroradiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Triquenot-Bagan', 'Affiliation': 'Department of Neurology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Anxionnat', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Derelle', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Tonnelet', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Schmitt', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Planel', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Guillemin', 'Affiliation': 'CIC 1433 Clinical Epidemiology, Nancy University Hospital, Université de Lorraine, Nancy, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, Nancy University Hospital, Nancy, France.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020929948'] 2280,32515748,Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study.,"BACKGROUND Adolescents are highly susceptible to negative self-perceptions, likely due to their social cues and environment. The presence of these negative self-perceptions has been shown to adversely impact levels of physical activity (PA). Although PA has the ability to foster improved self-perceptions, the rates of PA among adolescents continue to descend, with girls appearing to be most susceptible to these declines. At-risk adolescent girls, who may experience a number of negative preceding lifestyle conditions, may be exceptionally vulnerable to declines in PA. There are a high number of adolescent girls from low-income and abusive households in British Columbia, Canada, thus indicating a need for a program to relay the importance of PA and healthy lifestyle behaviors. OBJECTIVE This paper aims to describe the protocol of the Girls United and on the Move (GUM) pragmatic intervention, an integrated PA and psychosocial program aimed at improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls. METHODS Using a quasi-experimental mixed methods approach, the GUM intervention was conducted in 5 schools in British Columbia, Canada. Adolescent girls aged 11 to 15 years who were identified as at risk were included in the study. The 9-week intervention, co-delivered by a PA/health promotion-trained researcher and a registered social worker, involved a PA component and a psychosocial component with evidence-based topics addressing the concerns of the adolescent girls. The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment. Program acceptability and satisfaction was also examined. Outcome measures were assessed at baseline (week 1), week 6, and postintervention (week 9), and interview data concerning program acceptability and satisfaction were collected at postintervention from a subsample of participants. RESULTS A total of 101 participants were invited to participate in the GUM intervention. Reporting of the results is projected for the fall of 2020. CONCLUSIONS It is anticipated that the GUM intervention will enhance PA while also improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls. The findings of this research will contribute to the literature concerning PA and various psychosocial factors that impact the physical and mental health of at-risk adolescent girls. TRIAL REGISTRATION Clinicaltrials.gov NCT03567200; https://clinicaltrials.gov/ct2/show/NCT03567200. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15302.",2020,"The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment.","['risk adolescent girls', 'At-risk adolescent girls', 'Adolescent girls aged 11 to 15 years who were identified as at risk were included in the study', '101 participants were invited to participate in the GUM intervention', '5 schools in British Columbia, Canada']","['Integrated Physical Activity and Psychosocial Program', '9-week intervention, co-delivered by a PA/health promotion-trained researcher and a registered social worker, involved a PA component and a psychosocial component with evidence-based topics addressing the concerns of the adolescent girls', 'GUM intervention']","['Program acceptability and satisfaction', 'interview data concerning program acceptability and satisfaction', 'PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}]",101.0,0.0129728,"The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment.","[{'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Caperchione', 'Affiliation': 'School of Sport, Exercise and Rehabilitation, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hargreaves', 'Affiliation': 'School of Health and Exercise Science, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Okanagan School of Education, University of British Columbia Okanagan, Kelowna, BC, Canada.'}, {'ForeName': 'Kent C', 'Initials': 'KC', 'LastName': 'Kowalski', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Ferguson', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada.'}]",JMIR research protocols,['10.2196/15302'] 2281,32515840,"Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study.","The aim of this study was to compare seroma production in breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient. The patients were randomized to biological mesh in one breast and synthetical in the other. Twenty-four breasts were included. The total drain production and the daily drain production were similar in the two groups. After drain removal, there were more seroma aspirations in the biological group. During the exchange to a permanent implant, there was significantly more seroma in the biological group. Seroma formation is different in synthetic and biological meshes.",2020,The total drain production and the daily drain production were similar in the two groups.,['Twenty-four breasts were included'],['biological mesh'],"['total drain production and the daily drain production', 'Drain secretion and seroma formation', 'seroma', 'seroma production', 'Seroma formation', 'seroma aspirations']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",24.0,0.0234151,The total drain production and the daily drain production were similar in the two groups.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hansson', 'Affiliation': 'Department of Clinical Sciences, Plastic and Reconstructive Surgery, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Chatrin', 'Initials': 'AC', 'LastName': 'Edvinsson', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Hallberg', 'Affiliation': 'Department of Clinical Sciences, Plastic and Reconstructive Surgery, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}]",The breast journal,['10.1111/tbj.13921'] 2282,32515868,A randomized clinical trial for neck pain among adults.,,2020,,['neck pain among adults'],[],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.231617,,"[{'ForeName': 'Maryam M K', 'Initials': 'MMK', 'LastName': 'Bashir', 'Affiliation': 'College of Medicine and Health Sciences, Institute of Public Health, United Arab Emirates University, Al Ain, UAE.'}, {'ForeName': 'Elpidoforos S', 'Initials': 'ES', 'LastName': 'Soteriades', 'Affiliation': 'College of Medicine and Health Sciences, Institute of Public Health, United Arab Emirates University, Al Ain, UAE.'}]",Journal of occupational health,['10.1002/1348-9585.12119'] 2283,32515879,"Author Reply to ""A randomized clinical trial for neck pain among adults"".",,2020,,['neck pain among adults'],[],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.129782,,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Minami Seikyo Hospital, Nagoya-shi, Aichi-ken, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12127'] 2284,32515888,"Effects of obesity, metabolic syndrome, and non-alcoholic or alcoholic elevated liver enzymes on incidence of diabetes following lifestyle intervention: A subanalysis of the J-DOIT1.","OBJECTIVES Using annual health check-up data, the aim of this study was to identify target populations for lifestyle interventions to effectively prevent diabetes in a real-world setting. METHODS The Japan Diabetes Outcome Intervention Trial-1, a prospective, cluster-randomized controlled trial, was launched to test if year-long telephone-delivered lifestyle support by health professionals can prevent the development of type 2 diabetes (T2D) in people with impaired fasting glucose (IFG) identified at health check-ups. A total of 2607 participants aged 20-65 years with IFG were randomized to an intervention arm (n = 1240) or a control arm (n = 1367). We performed subgroup analysis to examine the effects of the intervention on the incidence of T2D in participants with body mass index (BMI) ≥25, metabolic syndrome (MetS), and non-alcoholic or alcoholic elevated liver enzymes at the baseline. Cox regression analysis adjusted for sex was used to calculate the hazard ratios (HRs). RESULTS In addition to IFG, the presence of BMI ≥25, MetS, and elevated liver enzymes increased the incidence of diabetes by two- or three-fold. During a median follow-up period of 4.9 years, only the non-alcoholic elevated liver enzyme group showed a low incidence rate owing to lifestyle interventions (adjusted HR: 0.42, 95% confidence interval: 0.18-0.98). CONCLUSION The results suggest that people who have IFG and non-alcoholic elevated liver enzymes are a good target population for lifestyle interventions to effectively reduce the incidence of diabetes in a real-world setting.",2020,"During a median follow-up period of 4.9 years, only the non-alcoholic elevated liver enzyme group showed a low incidence rate owing to lifestyle interventions (adjusted HR: 0.42, 95% confidence interval: 0.18-0.98). ","['people with impaired fasting glucose (IFG) identified at health check-ups', 'participants with body mass index (BMI) ≥25, metabolic syndrome (MetS), and non-alcoholic or alcoholic elevated liver enzymes at the baseline', '2607 participants aged 20-65\xa0years with IFG']",['telephone-delivered lifestyle support by health professionals'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",[],2607.0,0.14301,"During a median follow-up period of 4.9 years, only the non-alcoholic elevated liver enzyme group showed a low incidence rate owing to lifestyle interventions (adjusted HR: 0.42, 95% confidence interval: 0.18-0.98). ","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sakane', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Kotani', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Suganuma', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Juichi', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Department of General Medicine/Family & Community Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Sadao', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Health Management Center and Diagnostic Imaging Center, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Ichikawa Hospital, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nirengi', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Kuzuya', 'Affiliation': 'Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.'}]",Journal of occupational health,['10.1002/1348-9585.12109'] 2285,32515891,"Exercise training reduces workload, improves physical performance, and promotes overall health in welders.","OBJECTIVES Welders demonstrate a significant prevalence of work-related musculoskeletal disorders as indicated by high rates of illness-related absenteeism. The aim of the study was to investigate the effects of a 24-week exercise program on workload, physical performance, and overall health in welders. METHODS Seventy-seven professional welders were assigned to either a control group (CG), an endurance training group (ETG), or a strength training group (STG). Both groups conducted a 24-week, standardized and progressive endurance or resistance exercise training program. Before (TP1) and after training (TP2) all participants performed an experimental welding task (EWT) in order to test the hypothesis that training would reduce the relative load (%MVC) of eight skeletal muscles measured by surface electromyography. Secondary outcome measures included further EWT-induced stress parameters and a series of health-related outcome measures. RESULTS Results revealed a lower muscle load in participants of the ETG and STG for trapezius muscle at TP2 compared to T1 (P < .05 vs CG). Rate of perceived exertion and visual analogue scale were decreased, while increase of maximum EWT duration was found in participants of the ETG and STG after training (P < .05 vs CG). At T2, body fat (%) decreased and physical performance (bicycle exercise test, isometric strength of core muscles) increased in ETG and STG (P < .05). CONCLUSION Both regular endurance and strength training represent effective strategies for reducing workload and improving physical performance of welders. The results emphasize the importance of physical fitness for welders and might motivate health professionals in steel-industry to offer access to exercise training programs.",2020,"RESULTS Results revealed a lower muscle load in participants of the ETG and STG for trapezius muscle at TP2 compared to T1 (P < .05 vs CG).",['Seventy-seven professional welders'],"['standardized and progressive endurance or resistance exercise training program', '24-week exercise program', 'Exercise training', 'Before (TP1) and after training (TP2) all participants performed an experimental welding task (EWT', 'control group (CG), an endurance training group (ETG), or a strength training group (STG', 'regular endurance and strength training']","['workload, physical performance, and overall health in welders', 'physical performance (bicycle exercise test, isometric strength of core muscles) increased in ETG and STG (P', 'physical performance', 'Rate of perceived exertion and visual analogue scale', 'maximum EWT duration', 'further EWT-induced stress parameters and a series of health-related outcome measures']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336106', 'cui_str': 'Gas and electric welder (general)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336106', 'cui_str': 'Gas and electric welder (general)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",77.0,0.0187201,"RESULTS Results revealed a lower muscle load in participants of the ETG and STG for trapezius muscle at TP2 compared to T1 (P < .05 vs CG).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weyh', 'Affiliation': 'Department of Sports Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pilat', 'Affiliation': 'Department of Sports Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Sports Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Krüger', 'Affiliation': 'Department of Sports Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reichel', 'Affiliation': 'Department of Sports Exercise Physiology and Sports Therapy, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Frank-Christoph', 'Initials': 'FC', 'LastName': 'Mooren', 'Affiliation': 'Department of Rehabilitation Science, Witten/Herdecke University, Witten, Germany.'}]",Journal of occupational health,['10.1002/1348-9585.12122'] 2286,31500444,Duration of Heart Failure and Effect of Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure.,"BACKGROUND Patients with nonischemic systolic heart failure (HF) have increased risk of sudden cardiac death (SCD) and death from progressive pump failure. Whether the risk of SCD changes over time is unknown. We seek here to investigate the relation between duration of HF, mode of death, and effect of implantable cardioverter-defibrillator implantation. METHODS AND RESULTS We examined the risk of all-cause death and SCD according to the duration of HF among patients with nonischemic systolic HF enrolled in the DANISH (Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality). In all, 1116 patients were included. Patients were divided according to quartiles of HF duration (≤8, 9≤18, 19≤65, and ≥66 months). Patients with the longest duration of HF were older, more often men, had more comorbidity, and more often received a cardiac resynchronization therapy device. Doubling of HF duration was an independent predictor of both all-cause mortality (hazard ratio [HR], 1.27; 95% CI, 1.17-1.38; P<0.0001), and SCD (HR, 1.29; 95% CI, 1.11-1.50; P=0.0007). The proportion of deaths caused by SCD was not different between HF quartiles (P=0.91), and the effect of implantable cardioverter-defibrillator implantation on all-cause mortality was not modified by the duration of HF (P=0.59). CONCLUSIONS Duration of HF predicted both all-cause mortality and risk of SCD independently of other risk indicators. However, the proportion of death caused by SCD did not change with longer duration of HF, and the effect of implantable cardioverter-defibrillator was not modified by the duration of HF. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00542945.",2019,"The proportion of deaths caused by SCD was not different between HF quartiles (P=0.91), and the effect of implantable cardioverter-defibrillator implantation on all-cause mortality was not modified by the duration of HF (P=0.59). ","['Patients With Nonischemic Systolic Heart Failure', 'Patients with Non-ischemic Systolic Heart Failure on Mortality', '1116 patients were included', 'patients with nonischemic systolic HF enrolled in the DANISH (Danish Study', 'Patients with nonischemic systolic heart failure (HF']","['cardiac resynchronization therapy device', 'Defibrillator Implantation']","['Doubling of HF duration', 'proportion of deaths', 'proportion of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C2936377', 'cui_str': 'Cardiac Resynchronization Therapy Devices'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1116.0,0.0544628,"The proportion of deaths caused by SCD was not different between HF quartiles (P=0.91), and the effect of implantable cardioverter-defibrillator implantation on all-cause mortality was not modified by the duration of HF (P=0.59). ","[{'ForeName': 'Marie Bayer', 'Initials': 'MB', 'LastName': 'Elming', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Cardiology (A.M.T.), Aalborg University Hospital, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Denmark (L.V.).'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Faculty of Health and Medical Sciences (M.B.E., N.E.B., F.G., J.H.S., L.K., J.J.T.), University of Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Denmark (H.E., J.C.N.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark (J.H.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Egstrup', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Svendborg, Denmark (K.E.).'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hastrup Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Denmark (H.E., J.C.N.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet (M.B.E., J.H.S., F.G., D.E.H., S.P., L.K.), University of Copenhagen, Denmark.'}, {'ForeName': 'Jens Jakob', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Faculty of Health and Medical Sciences (M.B.E., N.E.B., F.G., J.H.S., L.K., J.J.T.), University of Copenhagen, Denmark.'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006022'] 2287,31502886,Platelet function in lung cancer patients undergoing lobectomy.,"A growing interest concerns arterial thromboembolic disease in cancer patients. As platelets may be key players in this process, investigation of platelet aggregation in cancer patients is of importance. We aimed to investigate platelet aggregation in patients with lung cancer prior to surgery and during video-assisted thoracoscopic surgery (VATS) lobectomy compared with lobectomy performed through a thoracotomy. We included 93 patients (VATS + low molecular weight heparin (LMWH), n  = 32; VATS no LMWH, n  = 31; thoracotomy + LMWH, n  = 30). Data obtained from 121 healthy individuals were used for comparison prior to surgery. Platelet aggregation was analysed by impedance aggregometry using adenosine diphosphate 6.5 μM (ADPtest) and collagen 3.2 μg/mL (COLtest) as agonists. Prior to surgery, platelet aggregation was significantly increased in both VATS-patients (ADPtest, p  < .0001; COLtest, p  = .0002) and patients undergoing thoracotomy (ADPtest, p  < .0001; COLtest, p  < .0001) compared with healthy individuals. Platelet aggregation did not differ between VATS-patients and thoracotomy patients prior to surgery ( p -values >.11). At the first postoperative day, VATS-patients demonstrated significantly higher collagen-induced platelet aggregation than preoperatively ( p  = .001), but the increase in platelet aggregation did not differ significantly between VATS and thoracotomy patients ( p -values ≥.24). At the second postoperative day, platelet aggregation was significantly reduced in thoracotomy patients compared with the preoperative level (ADPtest, p  = .002; COLtest, p  = .05). In conclusion, platelet aggregation was significantly increased in patients with primary lung cancer prior to surgery compared with healthy individuals. At the first postoperative day, platelet aggregation was significantly higher than the preoperative level in VATS-patients; however, this increase did not differ between patient groups.",2019,"Prior to surgery, platelet aggregation was significantly increased in both VATS-patients (ADPtest, p  < .0001; COLtest, p  = .0002) and patients undergoing thoracotomy (ADPtest, p  < .0001; COLtest, p  < .0001) compared with healthy individuals.","['cancer patients', 'lung cancer patients undergoing lobectomy', '93 patients (VATS\u2009+\u2009low molecular weight heparin (LMWH), n \u2009=\u200932; VATS no LMWH, n \u2009=\u200931; thoracotomy\u2009+\u2009LMWH, n \u2009=\u200930', 'patients with primary lung cancer', 'patients with lung cancer prior to surgery and during', '121 healthy individuals']",['video-assisted thoracoscopic surgery (VATS) lobectomy compared with lobectomy performed through a thoracotomy'],"['platelet aggregation', 'Platelet function', 'collagen-induced platelet aggregation', 'Platelet aggregation']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0369863', 'cui_str': 'Collagen induced platelet aggregation'}]",121.0,0.0187172,"Prior to surgery, platelet aggregation was significantly increased in both VATS-patients (ADPtest, p  < .0001; COLtest, p  = .0002) and patients undergoing thoracotomy (ADPtest, p  < .0001; COLtest, p  < .0001) compared with healthy individuals.","[{'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Biochemistry & Institute of Clinical Medicine, Aarhus University Hospital , Aarhus N , Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Vad', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital , Aarhus N , Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Pedersen', 'Affiliation': 'Department of Clinical Medicine, Aarhus University Hospital , Aarhus N , Denmark.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Licht', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Odense University Hospital , Odense C , Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Nybo', 'Affiliation': 'Department of Clinical Biochemistry, Odense University Hospital , Odense C , Denmark.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Hornbech', 'Affiliation': 'Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital , Copenhagen , Denmark.'}, {'ForeName': 'Nora Elisabeth', 'Initials': 'NE', 'LastName': 'Zois', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen University Hospital , Copenhagen , Denmark.'}, {'ForeName': 'Thomas Decker', 'Initials': 'TD', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital , Aarhus N , Denmark.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2019.1663555'] 2288,31520679,Exacerbation-prone asthma in the context of race and ancestry in Asthma Clinical Research Network trials.,"BACKGROUND Minority groups of African descent experience disproportionately greater asthma morbidity compared with other racial groups, suggesting that genetic variation from a common ancestry could influence exacerbation risk. OBJECTIVE We evaluated clinical trial measures in the context of self-reported race and genetic ancestry to identify risk factors for asthma exacerbations. METHODS One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n = 760). RESULTS Twenty-four percent of 1840 subjects self-identified as black. Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects. In the combined multiethnic cohort, neither race (P = .30) nor percentage of genetic African ancestry as a continuous variable associated with exacerbation risk (adjusted rate ratio [RR], 1.26 [95% CI, 0.94-1.70; P = .13]; RR per 1-SD change [32% ancestry], 0.97 [95% CI, 0.78-1.19; P = .74]). However, in 161 black subjects with genetic data, those with African ancestry greater than the median (≥82%) had a significantly greater risk of exacerbation (RR, 3.06 [95% CI, 1.09-8.6; P = .03]). CONCLUSION Black subjects have unique risk factors for asthma exacerbations, of which global African genetic ancestry had the strongest effect.",2019,"Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects.","['Twenty-four percent of 1840 subjects self-identified as black', 'One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n\xa0=\xa0760', '161 black subjects with genetic data']",[],"['exacerbation risk', 'asthma morbidity', 'risk of exacerbation', 'chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]",161.0,0.138303,"Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Grossman', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary and Critical Care, Lahey Hospital and Medical Center, Burlington, Mass.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. Electronic address: vortega@wakehealth.edu.'}, {'ForeName': 'Tonya S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University School of Medicine, Hershey, Pa.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Department of Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ampleford', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'Deparment of Internal Medicine, Divison of Allergy and Immunology, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tara F', 'Initials': 'TF', 'LastName': 'Carr', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary Diseases and Critical Care Medicine, University of Kansas, Kansas City, Kan.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine, Madison, Wis.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Denson', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fandino', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Pediatrics, Emory University, Atlanta, Ga.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hawkins', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, Colo.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Department of Medicine, University of Illinois Hospital & Health Sciences System, Chicago, Ill.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Sharmilee M', 'Initials': 'SM', 'LastName': 'Nyenhuis', 'Affiliation': 'Department of Medicine, University of Illinois Hospital & Health Sciences System, Chicago, Ill.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Sima K', 'Initials': 'SK', 'LastName': 'Ramratnam', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine, Madison, Wis.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Meyers', 'Affiliation': 'Department of Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.033'] 2289,31522562,Mild impairment of renal function (shrunken pore syndrome) is associated with increased risk for future surgery for aortic stenosis.,"Recently, a new approach was proposed to detect mild impairment in renal function: a reduced ratio between estimated glomerular filtration rate (eGFR) calculated by cystatin C and eGFR calculated by creatinine. We aimed to evaluate if this ratio is associated with aortic stenosis (AS) requiring surgery. We identified 336 patients that first participated in population surveys and later underwent surgery for AS (median age [interquartile range] 59.8 [10.3] years at survey and 68.3 [12.7] at surgery, 48% females). For each patient, two matched referents were allocated. Cystatin C and creatinine were determined in stored plasma. eGFR cystatin C and eGFR creatinine and their ratio were estimated. Conditional logistic regression analyses were used to estimate the risk (odds ratio (OR) with [95% confidence interval (CI)]) related to one (ln) standard deviation increase in the ratio between eGFR cystatin C and eGFR creatinine . A high ratio was associated with lower risk for AS requiring surgery (OR [95% CI]) (OR 0.84 [0.73-0.97]), especially in women (0.74 [0.60-0.92] vs. 0.93 [0.76-1.13] in men). After further stratification for coronary artery disease (CAD), the association remained in women with CAD but not in women without CAD (0.60 [0.44-0.83] and 0.89 [0.65-1.23], respectively). In conclusion, a high ratio between eGFR cystatin C and eGFR creatinine was associated with lower risk for surgery for AS, especially in women. Mild impairment of renal function is thus associated with future risk for AS requiring surgery.",2019,A high ratio was associated with lower risk for AS requiring surgery (OR [95% CI]),"['336 patients that first participated in population surveys and later underwent surgery for AS (median age [interquartile range] 59.8 [10.3] years at survey and 68.3 [12.7] at surgery, 48% females', 'Mild impairment of renal function (shrunken pore syndrome']",[],"['Mild impairment of renal function', 'eGFR cystatin C and eGFR creatinine and their ratio', 'Cystatin C and creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0658369,A high ratio was associated with lower risk for AS requiring surgery (OR [95% CI]),"[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ljungberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine and Heart Centre, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine and Heart Centre, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Ingvar A', 'Initials': 'IA', 'LastName': 'Bergdahl', 'Affiliation': 'Department of Biobank Research, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holmgren', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine and Heart Centre, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Näslund', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine and Heart Centre, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Hultdin', 'Affiliation': 'Department of Medical Biosciences, Clinical Chemistry, Umeå University , Umeå , Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Söderberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine and Heart Centre, Umeå University , Umeå , Sweden.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2019.1664761'] 2290,31554489,Validation of an Emotion Regulation Training Program on Mental Well-Being.,"This research aimed to validate an Emotion Regulation Training program cultivating resilience, strengthening interpersonal communication, and enhancing emotional intelligence. A community sample of 104 participants were assigned to either an intervention ( n  =   51) or nonactive control ( n  =   53) group matched by age and gender. In addition, data were gathered via a cognitive performance test conducted pre- and postmeasurement in a subset of the larger sample ( n  =   19 intervention, n  =   19 control). Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.",2019,"Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.",['A community sample of 104 participants'],"['Emotion Regulation Training Program', 'nonactive control']","['depressive symptomology, worry, and suppression']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",104.0,0.0281302,"Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Uzun', 'Affiliation': 'Department of Guidance and Counseling, Bahcesehir University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'Faculty of Educational Sciences, Bahcesehir University, Istanbul, Turkey.'}, {'ForeName': 'Changiz', 'Initials': 'C', 'LastName': 'Mohiyeddini', 'Affiliation': 'Department of Applied Psychology, Northeastern University, Boston, MA, USA.'}]",Psychological reports,['10.1177/0033294119878399'] 2291,31564217,"Effects of a Self-Compassion Break Induction on Self-Reported Stress, Self-Compassion, and Depressed Mood.","INTRODUCTION The objective of the study was to determine whether practicing a self-compassion induction would reduce self-reported stress, depressed mood, and increase self-compassion in a randomized controlled study measuring variables of interest at two time points spanning three weeks. METHOD Participants were 129 students (91 females and 38 males, M age  = 19.47, SD  = 3.20) divided into three groups: Self-compassion Break, Time Management Control Group, and a No-Induction Control Group. Participants were part of the general student body and were not diagnosed or screened for clinical depression. Self-compassion, stress, and depressed mood were assessed at baseline and follow-up. Participants practiced their respective inductions over three weeks after being guided through their respective inductions at Time 1. RESULTS There were no significant differences between groups in outcome variables. Results of this study may indicate the importance of weekly group check-in meetings to facilitate positive change as findings in this study did not mirror those of similar studies using frequent meetings.",2019,There were no significant differences between groups in outcome variables.,"['Participants were 129 students (91 females and 38 males, M age \u2009=\u200919.47, SD \u2009=\u20093.20) divided into three groups', 'Participants were part of the general student body and were not diagnosed or screened for clinical depression']","['Self-compassion Break, Time Management Control Group, and a No-Induction Control Group', 'Self-Compassion Break Induction']","['Self-Reported Stress, Self-Compassion, and Depressed Mood', 'Self-compassion, stress, and depressed mood']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]",129.0,0.0197939,There were no significant differences between groups in outcome variables.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychology, California State University, Bakersfield, Bakersfield, CA, USA.'}]",Psychological reports,['10.1177/0033294119877817'] 2292,31609869,A Pilot Study of the Effects of Chair Yoga and Chair-Based Exercise on Biopsychosocial Outcomes in Older Adults With Lower Extremity Osteoarthritis.,"This pilot study examined whether chair yoga and chair-based exercise are effective in managing biopsychosocial outcomes for older adults with lower extremity osteoarthritis. Both interventions improved physical function and mobility over time, although no significant differences between the 2 interventions were identified.",2019,"Both interventions improved physical function and mobility over time, although no significant differences between the 2 interventions were identified.","['Older Adults With Lower Extremity Osteoarthritis', 'older adults with lower extremity osteoarthritis']","['Chair Yoga and Chair-Based Exercise', 'chair yoga and chair-based exercise']","['Biopsychosocial Outcomes', 'physical function and mobility over time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0146791,"Both interventions improved physical function and mobility over time, although no significant differences between the 2 interventions were identified.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McCaffrey', 'Affiliation': 'Georgia Baptist College of Nursing (Dr McCaffrey), Physical Therapy, College of Health Professions (Dr Taylor), and Department of Clinical Psychology, College of Health Professions (Dr Marker), Mercer University, Dahlonega, Georgia; and Phyllis and Harvey Sandler School of Social Work, Florida Atlantic University, Boca Raton (Dr Park).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Marker', 'Affiliation': ''}, {'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}]",Holistic nursing practice,['10.1097/HNP.0000000000000355'] 2293,32520439,Cost-utility and cost-effectiveness analysis of a clinical medication review focused on personal goals in older persons with polypharmacy compared to usual care; economic evaluation of the DREAMeR study.,"BACKGROUND The ageing society may lead to increasing healthcare expenditure. A clinical medication review (CMR) could potentially reduce costs. OBJECTIVES To perform a cost-utility and cost-effectiveness analysis from a societal perspective of a patient-centred CMR. METHODS A trial-based cost-utility and cost-effectiveness analysis was performed as part of the DREAMeR study, a pragmatic controlled trial that randomised patients aged ≥70 years using ≥7 drugs to either CMR or usual care. Over six months, healthcare consumption and drug use were collected to estimate costs, and effects were collected in terms of quality-adjusted life years (QALYs) measured with EQ-5D-5L and EQ-VAS and as reduced health-related complaints with impact on patients' daily lives. RESULTS The total mean costs per patient (n=588) over six months were €4189±6596 for control group (n=294) and €4008±6678 for intervention group (n=294) including estimated interventions costs of €199±67, which resulted in a mean incremental total cost savings of €181 for the intervention group compared to the control group. Compared to control group, for the intervention group, the mean incremental QALYs over six months were: -0.00217 measured with EQ-5D and 0.003 measured with EQ-VAS.The incremental effect of reduced health-related complaints with impact was -0.34. There was a likelihood of >90% that the intervention was cost-saving. CONCLUSIONS The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives. Additionally, a CMR could potentially be cost saving from a societal perspective.",2020,The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives.,"['older persons with polypharmacy', 'patients aged ≥70 years using ≥7 drugs to either CMR or usual care']",['CMR'],"['total mean costs', 'mean incremental QALYs', 'mean incremental total cost savings', 'cost-saving', 'Cost-utility and cost-effectiveness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0718277,The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives.,"[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Verdoorn', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van de Pol', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.'}, {'ForeName': 'Anke M', 'Initials': 'AM', 'LastName': 'Hövels', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.'}, {'ForeName': 'Henk-Frans', 'Initials': 'HF', 'LastName': 'Kwint', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, the Netherlands.'}, {'ForeName': 'Jeanet W', 'Initials': 'JW', 'LastName': 'Blom', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14421'] 2294,32520445,Effect of long-term use of unfractionated or low-molecular-weight heparin on bone mineral density in maintenance hemodialysis patients.,"INTRODUCTION Long-term use of unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) causes bone loss and osteoporosis in patients not receiving hemodialysis. This study aimed to investigate the effect of UFH and LMWH on bone mineral density (BMD) in patients undergoing maintenance hemodialysis (MHD). METHODS Patients undergoing MHD using UFH or LMWH as anticoagulants were enrolled. BMD (in g/cm 2 ), T-score and Z-score (BMDs) were measured at the lumbar spine and femur neck using dual-energy X-ray absorptiometry (DXA) at baseline and 2 years later. Patient demographics and clinical indices were collected. Correlation analysis was used to identify significant predictors of bone loss. Multiple linear regression was used to explore the relationship between heparin type and bone loss progression. FINDINGS A total of 104 patients were enrolled and completed the baseline BMD test; 72 completed the test again 2 years later. Six patients were excluded because they used both UFH and LMWH. Although BMD decreased in some patients in the UFH group, a slight increase in the BMD was observed on an average in the LMWH group after 2 years. The mean change in BMD (in g/cm 2 ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group. Femur neck BMD did not change significantly. In a linear regression model, after adjusting for diabetes mellitus, parathyroid hormone, and serum phosphate, we did not find an association between heparin substances and BMD. DISCUSSION UFH might be associated with loss of lumbar spine BMD in patients undergoing MHD.",2020,"The mean change in BMD (in g/cm 2 ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group.","['Patients undergoing MHD using UFH or LMWH as anticoagulants were enrolled', '104 patients were enrolled and completed the baseline BMD test; 72 completed the test again 2\u2009years later', 'patients undergoing maintenance hemodialysis (MHD', 'patients undergoing MHD', 'maintenance hemodialysis patients', 'patients not receiving hemodialysis']","['LMWH', 'UFH and LMWH', 'unfractionated or low-molecular-weight heparin', 'UFH', 'unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH']","['bone mineral density', 'mean change in BMD', 'Femur neck BMD', 'BMD', 'bone mineral density (BMD', 'T-score and Z-score (BMDs', 'lumbar spine', 'lumbar spine BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",104.0,0.0402643,"The mean change in BMD (in g/cm 2 ) [0(-0.03,0.04) vs. 0.04(0,0.06), P = 0.023], T-score [0(-0.40,0.30) vs. 0.35(-0.03,0.53), P = 0.038], and Z-score [0.10(-0.30,0.40) vs. 0.45(0.08,0.63), P = 0.031] in the lumbar spine in the UFH group was lower than those in the LMWH group.","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Niu', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Liangying', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Lingxue', 'Initials': 'L', 'LastName': 'Tu', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12854'] 2295,32516009,Changes in EEG complexity with neurofeedback and multi-sensory learning in children with dyslexia: A multiscale entropy analysis.,"Multiscale entropy analysis (MSE) is a novel entropy-based approach for measuring dynamical complexity in physiological systems over a range of temporal scales. MSE has been successfully applied in the literature when measuring autism traits, Alzheimer's, and schizophrenia. However, until now, there has been no research on MSE applied to children with dyslexia. In this study, we have applied MSE analysis to the EEG data of an experimental group consisting of children with dyslexia as well as a control group consisting of typically developing children and compared the results. The experimental group comprised 16 participants with dyslexia who visited Ankara University Medical Faculty Child Neurology Department, and the control group comprised 20 age-matched typically developing children with no reading or writing problems. MSE was calculated for one continuous 60-s epoch for each experimental and control group's EEG session data. The experimental group showed significantly lower complexity at the lowest temporal scale and the medium temporal scales than the typically developing group. Moreover, the experimental group received 60 neurofeedback and multi-sensory learning sessions, each lasting 30 min, with Auto Train Brain. Post-treatment, the experimental group's lower complexity increased to the typically developing group's levels at lower and medium temporal scales in all channels.",2020,"Post-treatment, the experimental group's lower complexity increased to the typically developing group's levels at lower and medium temporal scales in all channels.","['children with dyslexia', '16 participants with dyslexia who visited Ankara University Medical Faculty Child Neurology Department, and the control group comprised 20 age-matched typically developing children with no reading or writing problems']","['Multiscale entropy analysis (MSE', 'neurofeedback and multi-sensory learning', '60 neurofeedback and multi-sensory learning sessions', 'MSE']",['MSE'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0587475', 'cui_str': 'Neurology department'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",16.0,0.0213465,"Post-treatment, the experimental group's lower complexity increased to the typically developing group's levels at lower and medium temporal scales in all channels.","[{'ForeName': 'Günet', 'Initials': 'G', 'LastName': 'Eroğlu', 'Affiliation': 'Faculty of Engineering and Natural Sciences, Sabancı University, Istanbul, Turkey.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Gürkan', 'Affiliation': 'Faculty of Engineering and Natural Sciences, Sabancı University, Istanbul, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Teber', 'Affiliation': 'Medical Faculty, Child Neurology Department, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Ertürk', 'Affiliation': 'HMS Health Mobile Software A.S., Ankara, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Kırmızı', 'Affiliation': 'Neuro Brain Academy, Izmir, Turkey.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Ekici', 'Affiliation': 'Özel Çocuk Nörolojisi Kliniği, Istanbul, Turkey.'}, {'ForeName': 'Fehim', 'Initials': 'F', 'LastName': 'Arman', 'Affiliation': 'Neurology Department, Acıbadem Hastanesi Kadıköy, Istanbul, Turkey.'}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Balcisoy', 'Affiliation': 'Faculty of Engineering and Natural Sciences, Sabancı University, Istanbul, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Özgüz', 'Affiliation': 'Faculty of Engineering and Natural Sciences, Sabancı University, Istanbul, Turkey.'}, {'ForeName': 'Müjdat', 'Initials': 'M', 'LastName': 'Çetin', 'Affiliation': 'Faculty of Engineering and Natural Sciences, Sabancı University, Istanbul, Turkey.'}]",Applied neuropsychology. Child,['10.1080/21622965.2020.1772794'] 2296,32516094,Comparison of individual and group-based load-velocity profiling as a means to dictate training load over a 6-week strength and power intervention.,"This study compared the effects of dictating load using individual (ILVP) or group (GLVP) load-velocity profiles on lower-body strength and power. Nineteen trained males (23.6 ± 3.7 years) completed a back squat one-repetition maximum (1-RM), load-velocity profiling (LVP), and countermovement (CMJ), static-squat (SSJ) and standing-broad (SBJ) jump tests before and after 6 weeks of resistance training. Participants were randomly assigned to an ILVP, or GLVP intervention with intra-session load dictated through real-time velocity monitoring and prediction of current relative performance using either the participant's LVP (ILVP) or a LVP based on all participant data (GLVP). Training resulted in significant increases in back squat 1-RM for the ILVP and GLVP group ( p < 0.01; 9.7% and 7.2%, respectively), with no group-by-time interaction identified between training groups ( p = 0.06). All jump performance significantly increased for the ILVP group ( p < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p < 0.05; 4.3%). Despite no significant group-by-time interaction across all variables, the ILVP intervention induced a greater magnitude of adaptation when compared to a GLVP approach. Additionally, an individualised approach may lead to greater positive transfer to power-based movements, specifically vertical and horizontal jumps.",2020,"All jump performance significantly increased for the ILVP group ( p < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p < 0.05; 4.3%).",['Nineteen trained males (23.6\xa0±\xa03.7\xa0years) completed a'],"['dictating load using individual (ILVP) or group (GLVP) load-velocity profiles', 'ILVP', ""ILVP, or GLVP intervention with intra-session load dictated through real-time velocity monitoring and prediction of current relative performance using either the participant's LVP (ILVP) or a LVP based on all participant data (GLVP""]","['back squat one-repetition maximum (1-RM), load-velocity profiling (LVP), and countermovement (CMJ), static-squat (SSJ) and standing-broad (SBJ) jump tests', 'back squat 1-RM']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",19.0,0.0213899,"All jump performance significantly increased for the ILVP group ( p < 0.01; CMJ: 6.6%; SSJ: 4.6%; SBJ: 6.7%), with only CMJ and SSJ improving for the GLVP group ( p < 0.05; 4.3%).","[{'ForeName': 'Harry F', 'Initials': 'HF', 'LastName': 'Dorrell', 'Affiliation': 'School of Sport and Exercise Science, College of Social Sciences, University of Lincoln , Lincoln, UK.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Moore', 'Affiliation': 'School of Sport, Health and Exercise Science, Faculty of Science and Health, University of Portsmouth , Portsmouth, UK.'}, {'ForeName': 'Thomas I', 'Initials': 'TI', 'LastName': 'Gee', 'Affiliation': 'School of Sport and Exercise Science, College of Social Sciences, University of Lincoln , Lincoln, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1767338'] 2297,32516149,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial: Erratum.,,2020,,['after Ambulatory Surgery'],['Olanzapine'],['Postdischarge Nausea and Vomiting'],"[{'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.139129,,[],Anesthesiology,['10.1097/ALN.0000000000003438'] 2298,32516182,Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation: A randomised controlled trial.,,2020,,[],['Oblique versus longitudinal axis/in-plane approaches for ultrasound-guided radial arterial cannulation'],[],[],"[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",[],,0.165901,,"[{'ForeName': 'Chao-Kun', 'Initials': 'CK', 'LastName': 'Zeng', 'Affiliation': 'From the Department of Anaesthesiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, PR China (Z-CK, Z-GF, D-JH, L-DW).'}, {'ForeName': 'Gao-Feng', 'Initials': 'GF', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jin-He', 'Initials': 'JH', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'De-Wei', 'Initials': 'DW', 'LastName': 'Li', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001186'] 2299,32516184,Acute pain after serratus anterior plane or thoracic paravertebral blocks for video-assisted thoracoscopic surgery: A randomised trial. Retraction.,,2020,,[],"['serratus anterior plane or thoracic paravertebral blocks', 'video-assisted thoracoscopic surgery']",['Acute pain'],[],"[{'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}]",,0.259756,,[],European journal of anaesthesiology,['10.1097/EJA.0000000000001258'] 2300,32516227,Methadone for postoperative analgesia: contribution of N-methyl-D-aspartate receptor antagonism: A randomised controlled trial.,"BACKGROUND Over the past number of years, N-methyl-D-aspartate (NMDA) inhibitory drugs, like ketamine, have been introduced as adjuvant treatments for postoperative acute pain, within a multimodal approach. A further extension of this strategy could be the use of opioids with NMDA receptor (NMDAr) antagonism activity for control of postoperative pain. Methadone has a unique pharmacodynamic profile: it is both a μ-agonist and an NMDAr-blocker. OBJECTIVE We designed this study to investigate the precise contribution of NMDAr antagonism in methadone-induced analgesia. DESIGN Single-centre, prospective, randomised, double-blind study. SETTING National Cancer Center - Fondazione IRCCS Istituto Nazionale Tumori Milano; patients were recruited between March 2010 and June 2012. PATIENTS Ninety-six patients scheduled for an open laparotomy for anterior resection of the rectum. INTERVENTIONS We randomly assigned patients to four groups: 0-Mo (placebo and morphine), K-Mo [S(+)-ketamine and morphine], 0-Me (placebo and methadone), K-Me [S(+)-ketamine and methadone]. MAIN OUTCOME MEASURES The primary end-point was the extent of mechanical static (punctuate) hyperalgesia to von Frey hair stimulation lateral to the surgical incision. RESULTS Peri-incisional hyperalgesia was 8.4 cm (95% confidence interval, 1.5 to 15.41) lower in the treatment group (K-Me) compared with the control group (0-Mo) at 24 h after surgery (P = 0.02). No significant differences were observed between the groups at 48 h after surgery (P = 0.86). Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h. At 48 h, only the movement Numerical Rating Scale was significantly lower. No difference occurred in opioid consumption. CONCLUSION Methadone provides effective control of acute postoperative pain, independently, by modulation of the hyperalgesia mechanism. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, no.: NCT01594047.",2020,"Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h.","['Ninety-six patients scheduled for an open laparotomy for anterior resection of the rectum', 'National Cancer Center - Fondazione IRCCS Istituto Nazionale Tumori Milano; patients were recruited between March 2010 and June 2012']","['placebo and morphine), K-Mo', 'N-methyl-D-aspartate receptor antagonism', '0-Mo', 'placebo and methadone), K-Me', 'S(+)-ketamine and morphine', 'methadone', 'Methadone', 'S(+)-ketamine and methadone']","['movement Numerical Rating Scale', 'mechanical static (punctuate) hyperalgesia to von Frey hair stimulation lateral to the surgical incision', 'Numerical Rating Scale', 'opioid consumption', 'pain', 'Peri-incisional hyperalgesia']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",96.0,0.486354,"Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h.","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tognoli', 'Affiliation': 'From the Department of Anesthesiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy (ET, PLP, FV), the Department of Anesthesiology ASST Vimercate Monza-Brianza, Italy (GM), the Department of Clinical Science and Comunity, University of Milan, Milano, Italy (CG), the Unit of Clinical epidemiology and Trial organization, Fondazione IRCCS Istituto nazionale dei Tumori, Milano, Italy (LM), and the Department of Oncology and Onco-Hematology, University Of Milan, Milano, Italy (FV).'}, {'ForeName': 'Paolo L', 'Initials': 'PL', 'LastName': 'Proto', 'Affiliation': ''}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Galeone', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': ''}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Valenza', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001217'] 2301,32516270,"Crossover associations of alcohol and smoking, craving and biochemically verified alcohol and nicotine use in heavy drinking smokers.","OBJECTIVES This study examined associations between drinking and smoking prior to treatment (biochemically measured at baseline), alcohol and tobacco craving, and biochemical alcohol and tobacco use during the analog trial period. METHODS We conducted a secondary data analysis of a randomized clinical analog trial where participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited. A generalized estimation equation model for longitudinal binary outcomes was created (N = 34) to determine the predictive effects of baseline tobacco use, alcohol craving, and tobacco craving on alcohol use over the 4 weeks of the trial. RESULTS Baseline smoking was significantly (*p < 0.05) associated with drinking over time [odds ratio (OR) = 3.09*], while baseline drinking was associated with smoking (OR = 4.17*). Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92*, respectively) but were negatively associated with alcohol use over time (OR = 0.79* and OR = 0.57*, respectively). CONCLUSION Heavier use of either tobacco or alcohol preceding treatment may require more intensive interventions in order to reduce tobacco and alcohol use. Future trials designed to address mechanisms of behavior change in the context of novel treatments could promote a better understanding of the cross-rewarding effects related to the co-use of these substances and lead to the development of more integrated and appropriately intense treatments for individuals with concomitant tobacco and alcohol use disorders.",2020,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"['individuals with concomitant tobacco and alcohol use disorders', 'heavy drinking smokers', 'participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited']",['tobacco or alcohol'],"['Baseline alcohol and tobacco craving', 'alcohol and tobacco craving, and biochemical alcohol and tobacco use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]",,0.0128751,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"[{'ForeName': 'Crystal Lederhos', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Jenkins', 'Affiliation': 'Prevention Science.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Burduli', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Tham', 'Affiliation': 'Elson S. Floyd College of Medicine.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Miguel', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'Mcpherson', 'Affiliation': 'Program of Excellence in Addictions Research.'}]",Behavioural pharmacology,['10.1097/FBP.0000000000000568'] 2302,32516282,"Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2).","BACKGROUND Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor that has previously demonstrated efficacy in the treatment of influenza in adults and adolescents. We assessed the safety and efficacy of baloxavir in otherwise healthy children with acute influenza. METHODS MiniSTONE-2 (Clinicaltrials.gov: NCT03629184) was a double-blind, randomized, active controlled trial enrolling children 1-<12 years old with a clinical diagnosis of influenza. Children were randomized 2:1 to receive either a single dose of oral baloxavir or oral oseltamivir twice daily for 5 days. The primary endpoint was incidence, severity and timing of adverse events (AEs); efficacy was a secondary endpoint. RESULTS In total, 173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group. Characteristics of participants were similar between treatment groups. Overall, 122 AEs were reported in 84 (48.6%) children. Incidence of AEs was similar between baloxavir and oseltamivir groups (46.1% vs. 53.4%, respectively). The most common AEs were gastrointestinal (vomiting/diarrhea) in both groups [baloxavir: 12 children (10.4%); oseltamivir: 10 children (17.2%)]. No deaths, serious AEs or hospitalizations were reported. Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir. CONCLUSIONS Oral baloxavir is well tolerated and effective at alleviating symptoms in otherwise healthy children with acute influenza. Baloxavir provides a new therapeutic option with a simple oral dosing regimen.",2020,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir. ","['otherwise healthy children with acute influenza', 'children 1-<12 years old with a clinical diagnosis of influenza', 'adults and adolescents', '12 children (10.4', 'Influenza-infected Children', '10 children (17.2', '173 children were randomized and dosed, 115 to the baloxavir group and 58 to the oseltamivir group']","['oseltamivir', 'Baloxavir', 'baloxavir', 'Baloxavir Marboxil Single-dose Treatment', 'oral baloxavir or oral oseltamivir', 'Baloxavir marboxil (baloxavir']","['alleviation of signs and symptoms of influenza', 'incidence, severity and timing of adverse events (AEs); efficacy', 'No deaths, serious AEs or hospitalizations', 'safety and efficacy', 'Incidence of AEs', 'Median time', 'gastrointestinal (vomiting/diarrhea']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",173.0,0.517593,"Median time (95% confidence interval) to alleviation of signs and symptoms of influenza was similar between groups: 138.1 (116.6-163.2) hours with baloxavir versus 150.0 (115.0-165.7) hours with oseltamivir. ","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'From the Clinical Research Prime, Idaho Falls, Idaho.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Block', 'Affiliation': 'Kentucky Pediatric and Adult Research Inc., Bardstown, Kentucky.'}, {'ForeName': 'Balpreet', 'Initials': 'B', 'LastName': 'Matharu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burleigh Macutkiewicz', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wildum', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dimonaco', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Collinson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Clinch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Welwyn Garden City, Hertfordshire, United Kingdom.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002747'] 2303,32516291,Effects of dapagliflozin and gliclazide on the cardiorenal axis in people with type 2 diabetes.,"OBJECTIVES There is a bidirectional relationship between cardiovascular and renal disease. The drug-class of SGLT2 inhibitors improves outcomes at both ends of this so called cardiorenal axis. We assessed the effects of SGLT2 inhibition and sulfonylurea treatment on systemic hemodynamic function and investigated whether SGLT2 inhibitor-induced changes in systemic hemodynamics correlate with changes in renal hemodynamics. METHODS Forty-four people with type 2 diabetes were randomized to 12 weeks of dapagliflozin 10 mg/day or gliclazide 30 mg/day treatment. Systemic hemodynamic function, autonomic nervous system activity, and vascular stiffness were measured noninvasively, whereas renal hemodynamics, glomerular filtration rate (GFR) and effective renal plasma flow, were assessed with gold-standard urinary clearances of inulin or iohexol and para-aminohippuric acid, respectively. Correlation analyses were performed to assess relationships between dapagliflozin-induced changes in cardiovascular and renal variables. RESULTS Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%. Despite similar improvements in glycemic control by dapagliflozin and gliclazide (-0.5 ± 0.5 versus-0.7 ± 0.5%; P = 0.12), gliclazide did not affect any of these measurements. There was no clear association between the dapagliflozin-induced changes in cardiovascular and renal physiology. CONCLUSION Dapagliflozin seemingly influences systemic and renal hemodynamics independently and beyond glucose lowering in people with type 2 diabetes.This clinical trial was registered at https://clinicalTrials.gov (ID: NCT02682563).",2020,"RESULTS Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%.","['people with type 2 diabetes', 'Forty-four people with type 2 diabetes']","['gliclazide', 'dapagliflozin and gliclazide', 'dapagliflozin', 'SGLT2 inhibitors', 'SGLT2 inhibition and sulfonylurea', 'dapagliflozin 10\u200amg/day or gliclazide', 'Dapagliflozin']","['heart rate or sympathetic activity', 'cardiovascular and renal physiology', 'stroke volume', 'cardiac output', 'systemic and renal hemodynamics', 'vascular stiffness', 'mean arterial pressure', 'glomerular filtration rate', 'renal hemodynamics, glomerular filtration rate (GFR) and effective renal plasma flow', 'cardiovascular and renal variables', 'glycemic control', 'Systemic hemodynamic function, autonomic nervous system activity, and vascular stiffness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206088', 'cui_str': 'Effective renal plasma flow'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",44.0,0.164568,"RESULTS Dapagliflozin reduced stroke volume by 4%, cardiac output by 5%, vascular stiffness by 11%, and mean arterial pressure by 5% from baseline, without increasing heart rate or sympathetic activity, while simultaneously lowering glomerular filtration rate by 8%.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Danique', 'Initials': 'D', 'LastName': 'Ruiter', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Amsterdam.'}]",Journal of hypertension,['10.1097/HJH.0000000000002480'] 2304,32516300,Improving Spatiotemporal Gait Asymmetry Has Limited Functional Benefit for Individuals Poststroke.,"BACKGROUND AND PURPOSE Prior literature suggests a relationship between spatiotemporal gait asymmetry and metabolic cost of walking, balance, endurance, quality of life, and physical activity in people with chronic stroke. Our purpose was to determine whether targeting spatiotemporal gait symmetry would concomitantly improve these measures. METHODS This study represents secondary outcome measures from a trial in which 48 participants with chronic stroke were randomized to groups that all targeted spatiotemporal gait asymmetry. Measures of balance, daily step count, endurance (6-minute walk test [6MWT), metabolic cost of walking, quality of life (Stroke Impact Scale [SIS]), and overground spatiotemporal asymmetries were collected 1 week prior to and following training. Separate analyses were performed for those who trained for spatial versus temporal asymmetry. The effect of time (pre/post) was examined for all measures and correlational analyses evaluated the potential relationships between changes in spatiotemporal asymmetry and all other measures. RESULTS Individuals who trained to target step length asymmetry improved balance, 6MWT distance, metabolic cost of walking, and SIS-Mobility. Individuals who trained to target stance time asymmetry improved balance, 6MWT distance, SIS-Mobility, and SIS-Global recovery scores. However, step length asymmetry improvements were only related to improved 6MWT distance (P = 0.025; r = -0.49). Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558). DISCUSSION AND CONCLUSIONS Despite a targeted training approach and noted improvements in most measures, these changes did not appear to arise from improved spatiotemporal gait asymmetry. Furthermore, improvements in gait function observed in the laboratory setting did not appear to translate to increased community mobility.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A316).",2020,"Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558). ","['48 participants with chronic stroke', 'people with chronic stroke']",[],"['balance, 6MWT distance, SIS-Mobility, and SIS-Global recovery scores', 'spatiotemporal gait asymmetry and metabolic cost of walking, balance, endurance, quality of life, and physical activity', 'spatiotemporal gait asymmetry', '6MWT distance', 'metabolic cost of walking', 'community mobility', 'balance, 6MWT distance, metabolic cost of walking, and SIS-Mobility', 'gait function', 'balance, daily step count, endurance (6-minute walk test [6MWT), metabolic cost of walking, quality of life (Stroke Impact Scale [SIS]), and overground spatiotemporal asymmetries']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",48.0,0.0316495,"Stance time asymmetry improvements were only related to improved metabolic cost of walking (P = 0.031; r = 0.558). ","[{'ForeName': 'Hannah P', 'Initials': 'HP', 'LastName': 'Ryan', 'Affiliation': 'Division of Physical Therapy, Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Carty', 'Initials': 'C', 'LastName': 'Husted', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lewek', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000321'] 2305,32516410,Impact of myoglobin oxygenation level on color stability of frozen beef steaks.,"The emerging market of frozen meat emphasizes the need to better understand beef surface discoloration and the ideal parameters of freezing beef to retain an acceptable color. The objectives of this study were to determine the impacts of myoglobin oxygenation level prior to freezing and frozen storage duration on frozen beef color. USDA Choice strip loins (n=36) were aged for 4 d or 20 d. Steaks were randomly assigned to a myoglobin oxygenation level [deoxymyoglobin (DeOxy; immediately packaged after cutting), oxygenation (Oxy; oxygenated in air for 30 minutes), or high oxygenation (HiOxy; packaged for 24 h in 80% O2)]. Steaks were then vacuum packaged in oxygen permeable or impermeable film and immediately frozen (-5°C). Following either 0, 2, 4, or 6 months of frozen storage, steaks were removed from the packaging and immediately analyzed for instrumental color (L*, a*, b*), percent oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, a*:b* ratio, hue angle, subjective discoloration, and lipid oxidation. The HiOxy steaks had greater oxygen penetration and the greatest a* values compared to DeOxy and Oxy steaks, regardless of packaging (P < 0.0005). With 4 d of aging, HiOxy steaks had greater a* values than DeOxy and Oxy at all storage times (P = 0.0118). The HiOxy steaks aged for 20 d and frozen for 6 months had significantly higher delta E values than all other myoglobin oxygenation levels and postmortem aging periods (P < 0.0001). Redness and percent oxymyoglobin were highest for HiOxy steaks within each storage period (P < 0.0002). The HiOxy steaks had the highest percent oxymyoglobin and DeOxy had the lowest percent oxymyoglobin within each aging and storage period (P < 0.01). Conversely, DeOxy steaks had the highest percent metmyoglobin and HiOxy had the lowest percent metmyoglobin when packaged in impermeable film (P < 0.0001). The HiOxy steaks from 20 d of aging had the highest discoloration compared to 4 d aging and more discoloration than all other myoglobin treatments at 6 months of storage (P < 0.0001). The HiOxy 20 d aged steaks exhibited the highest lipid oxidation values at 2, 4, and 6 months (P = 0.0224) and HiOxy steaks exhibited a brighter and deeper cherry red color compared to the DeOxy steaks. The HiOxy steaks were greater in redness or similar when compared to Oxy steaks, but experienced more detrimental effects when frozen storage was extended.",2020,"The HiOxy steaks had greater oxygen penetration and the greatest a* values compared to DeOxy and Oxy steaks, regardless of packaging (P < 0.0005).","['n=36) were aged for 4 d or 20 d. Steaks', 'frozen beef steaks']","['myoglobin oxygenation level', 'USDA Choice strip loins', 'myoglobin oxygenation level [deoxymyoglobin (DeOxy; immediately packaged after cutting), oxygenation (Oxy; oxygenated in air for 30 minutes), or high oxygenation (HiOxy']","['discoloration', 'delta E values', 'oxygen penetration', 'highest lipid oxidation values', 'percent oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, a*:b* ratio, hue angle, subjective discoloration, and lipid oxidation', 'Redness and percent oxymyoglobin', 'HiOxy steaks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0452850', 'cui_str': 'Beef steak'}]","[{'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085410', 'cui_str': 'Department of Agriculture (U.S.)'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0446502', 'cui_str': 'Loin (surface region)'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0851043', 'cui_str': 'Increased lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0069830', 'cui_str': 'oxymyoglobin'}, {'cui': 'C0025852', 'cui_str': 'Metmyoglobin'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.0302624,"The HiOxy steaks had greater oxygen penetration and the greatest a* values compared to DeOxy and Oxy steaks, regardless of packaging (P < 0.0005).","[{'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Henriott', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}, {'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Herrera', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}, {'ForeName': 'Kellen B', 'Initials': 'KB', 'LastName': 'Hart', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bland', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Calkins', 'Affiliation': 'Department of Animal Science, University of Nebraska - Lincoln.'}]",Journal of animal science,['10.1093/jas/skaa193'] 2306,32516483,Cycling-specific isometric resistance training improves peak power output in elite sprint cyclists.,"INTRODUCTION This study aimed to assess the efficacy of a six-week cycling-specific, isometric resistance training programme on peak power output (PPO) in elite cyclists. METHODS Twenty-four elite track sprint cyclists were allocated to EXP (n=13, PPO, 1537 ± 307 W) and CON (n=11, PPO, 1541 ± 389 W) groups. All participants completed a six-week training programme; training content was identical except participants in the EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus. Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture were assessed pre- and post-training. RESULTS In EXP, absolute and relative PPO increased (46 ± 62 W and 0.8 ± 0.7 W⋅kg -1 , p < 0.05), and the change in relative PPO was different to CON (-0.1 ± 1.0 W⋅kg -1 , group × time interaction p = 0.02). The increase in PPO was concurrent with an increase in extrapolated maximal torque in EXP (7.1 ± 6.5 N⋅m, p = 0.007), but the effect was not different from the change in CON (2.4 ± 9.7 N⋅m, group × time p = 0.14). Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002). There were no other between-group differences in response to training. CONCLUSION A six-week novel, cycling-specific isometric resistance training period improved PPO in a group of elite sprint cyclists by 3-4%. These data support the use of a cycling-specific isometric resistance training stimulus in the preparation programmes of world-class cyclists.",2020,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"['elite cyclists', 'world-class cyclists', 'elite\xa0sprint cyclists', 'Twenty-four elite track sprint cyclists']","['EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus', 'Cycling-specific isometric resistance training', 'EXP', 'CON', 'six-week cycling-specific, isometric resistance training programme']","['Cycling-specific isometric strength', 'change in relative PPO', 'PPO', 'absolute and relative PPO', 'peak power output (PPO', 'Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture', 'extrapolated maximal torque']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",,0.0195751,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"[{'ForeName': 'Authors Mehdi', 'Initials': 'AM', 'LastName': 'Kordi', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Folland', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Leics, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Menzies', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Tejal Sarika', 'Initials': 'TS', 'LastName': 'Patel', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The Football Association, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13742'] 2307,32516486,A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension.,"Interactive voice response and text message (IVR-T) technology may improve hypertension control in under-resourced settings. We conducted a randomized clinical trial to determine whether an IVR-T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety-five participants were randomly assigned to IVR-T (N = 148) or to usual care (N = 147). The IVR-T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self-reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12-month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self-reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.",2020,Hg in the intervention group (P values = .57,"['adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico', 'individuals with hypertension', 'Two hundred and ninety-five participants']","['IVR-T', 'IVR-T intervention', 'interactive voice response and text message intervention', 'Interactive voice response and text message (IVR-T) technology']","['change in SBP between baseline and 6\xa0months, change in diastolic BP (DBP) at 6 and 12\xa0months, self-reported adherence', 'change in systolic BP (SBP', 'blood pressure (BP), medication adherence and visit keeping', 'percentage of kept visits', 'Self-reported medication adherence', 'SBP or DBP', 'SBP/DBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}]",295.0,0.0501178,Hg in the intervention group (P values = .57,"[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Moore', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Spero M', 'Initials': 'SM', 'LastName': 'Manson', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Baldwin', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Goodrich', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Allen S', 'Initials': 'AS', 'LastName': 'Malone', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Pieper', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Meredith P', 'Initials': 'MP', 'LastName': 'Fort', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Son-Stone', 'Affiliation': 'First Nations Community HealthSource, Albuquerque, NM, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'First Nations Community HealthSource, Albuquerque, NM, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Steiner', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13909'] 2308,32516494,The Impact of Treatment Description Format on Patient Preferences for Posttraumatic Stress Disorder Treatment.,"The present study examined how the format in which treatment information is presented impacts individuals' preferences for posttraumatic stress disorder (PTSD) treatments. Adults who screened positive for PTSD (N = 301) were randomized into groups to learn about five first-line treatments; participants either read sequential text descriptions or reviewed a comparison chart that presented side-by-side information. Participants rated treatment acceptability, rank ordered treatments from most to least preferred, and indicated their confidence in this ranking. Compared with participants in the text group, those in the chart group assigned more favorable acceptability ratings to prolonged exposure therapy (PE) and more moderate ratings to medications. Cognitive processing therapy was the most common first-choice treatment (43.6%). Forced-choice treatment rankings were similar across conditions, although participants in the chart group ranked PE more favorably than those in the text group, odds ratio (OR) = 0.54, 95% CI [0.35, 0.82], p = .004. Confidence in treatment rankings did not differ across conditions. The results suggest that perceptions of treatment acceptability can be influenced by the format in which treatment information is presented. In settings where the goal is to increase treatment acceptability, side-by-side formats may offer an advantage over sequential descriptions of each treatment.",2020,Confidence in treatment rankings did not differ across conditions.,"['Patient Preferences for Posttraumatic Stress Disorder Treatment', 'Adults who screened positive for PTSD (N = 301']","['learn about five first-line treatments; participants either read sequential text descriptions or reviewed a comparison chart that presented side-by-side information', 'Cognitive processing therapy']",['favorable acceptability ratings'],"[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",301.0,0.0278761,Confidence in treatment rankings did not differ across conditions.,"[{'ForeName': 'Juliette M', 'Initials': 'JM', 'LastName': 'Harik', 'Affiliation': 'National Center for PTSD-Executive Division, White River Junction, Vermont, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hamblen', 'Affiliation': 'National Center for PTSD-Executive Division, White River Junction, Vermont, USA.'}]",Journal of traumatic stress,['10.1002/jts.22528'] 2309,32516497,Usefulness of home-use microneedle devices in the treatment of pattern hair loss.,"BACKGROUND Microneedle devices have been used to reduce scarring and wrinkling as well as for the treatment of pattern hair loss. OBJECTIVE Here, we investigated the efficacy and safety of a newly developed home-use microneedle device for the treatment of pattern hair loss. METHODS Twenty-nine patients were assigned into three groups based on block randomization: home-use microneedle device only, a combination of home-use microneedle device and 5% minoxidil solution and 5% minoxidil topical solution only. Each treatment was performed twice a week. The study outcomes included hair counts, patient self-assessments and adverse events at baseline and at 6 months. Statistical analyses were performed using analysis of variance (ANOVA), repeated measures ANOVA and Kruskal Wallis test. RESULTS The improvements in hair count were seen in the combination group at month 6, but the differences observed did not reach statistical significance in each group and among the three groups. The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups. Mild and transient pruritus was reported by one patient who was using the microneedle device only. CONCLUSIONS Our study shows that the home-use microneedle device may be a safe and 5% minoxidil solution penetration-enhancing therapeutic modality for stimulating hair growth.",2020,"The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups.","['pattern hair loss', 'Twenty-nine patients']","['block randomization: home-use microneedle device only, a combination of home-use microneedle device and 5% minoxidil solution and 5% minoxidil topical solution only']","['efficacy and safety', 'Mild and transient pruritus', 'hair count', 'hair counts, patient self-assessments and adverse events']","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0307514', 'cui_str': 'Minoxidil Topical Solution [Rogaine]'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",29.0,0.0324985,"The patient self-assessment showed the highest score in the combination group, but it did not reveal a statistically significant difference among the three groups.","[{'ForeName': 'Chihyeon', 'Initials': 'C', 'LastName': 'Sohng', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Soo Kyeong', 'Initials': 'SK', 'LastName': 'Woo', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Jun Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Seok-Jong', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13540'] 2310,32516507,Influence of hand and rotary files for endodontic treatment of primary teeth on immediate outcomes: secondary analysis of a randomized controlled trial.,"BACKGROUND Endodontic treatment of primary teeth can be time consuming. AIM To compare hand and rotary files regarding the time for root canal chemical-mechanical preparation, child's behavior, apical limit of the obturation, and postoperative pain. DESIGN This secondary data from a randomized clinical trial with two parallel arms evaluated endodontic instrumentation in 88 children aged four to nine years. Stratified and block randomization was performed into two groups: K-file hand and ProDesign Logic rotary files. The evaluated outcomes were the chemical-mechanical preparation time, child's behavior using the Frankl scale, apical limit of the obturation, and postoperative pain using the Faces Pain Scale-Revised. One operator and all outcome appraisers were blinded to the chemical-mechanical technique. Multiple linear regression, Chi-square, and Fisher´s exact test were performed. RESULTS The mean time for chemical-mechanical preparation using hand files was 24.5 (SD 4.0) minutes, and using rotary files it was 17.0 (SD 2.5) minutes (p < 0.001). No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or postoperative pain. CONCLUSIONS The ProDesign Logic file reduced the average procedure time but presented no difference in the other variables studied when compared to the K-file.",2020,"No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or postoperative pain. ",['88 children aged four to nine years'],[],"[""child's behavior, apical limit of the obturation, or postoperative pain"", 'mean time for chemical-mechanical preparation', ""chemical-mechanical preparation time, child's behavior using the Frankl scale, apical limit of the obturation, and postoperative pain using the Faces Pain Scale-Revised""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",88.0,0.124704,"No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or postoperative pain. ","[{'ForeName': 'Jéssica Copetti', 'Initials': 'JC', 'LastName': 'Barasuol', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Delfino Conti Street, Trindade, Zip code: 88040-900, Florianópolis, SC, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Massignan', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Delfino Conti Street, Trindade, Zip code: 88040-900, Florianópolis, SC, Brazil.'}, {'ForeName': 'Eduardo Antunes', 'Initials': 'EA', 'LastName': 'Bortoluzzi', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Delfino Conti Street, Trindade, Zip code: 88040-900, Florianópolis, SC, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Delfino Conti Street, Trindade, Zip code: 88040-900, Florianópolis, SC, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Delfino Conti Street, Trindade, Zip code: 88040-900, Florianópolis, SC, Brazil.'}]",International journal of paediatric dentistry,['10.1111/ipd.12682'] 2311,32516725,"Inflammatory cytokines and DNA methylation in healthy young adults exposure to fine particulate matter: A randomized, double-blind crossover trial of air filtration.","Benefits of indoor air filtration in heavily polluted areas are not fully understood. This study aims to examine whether short-term air filtration intervention could attenuate the hazards from acute exposure to fine particulate matter (PM 2.5 ), and investigate the potential impact on inflammatory cytokines and DNA methylation. A randomized, double-blind crossover trial of true or sham indoor air filtration was conducted among 29 healthy young adults in Beijing, China. Each episode covered a typical air pollution wave, and 38 cytokines and DNAm of 20 genes were measured at 3 time points: pre-smog, during smog, and post-smog. Linear mixed-effect models were used to evaluate the associations. The indoor PM 2.5 concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3 vs. 42.8 μg/m 3 ). Air filtration was significantly associated with the decreases in 9 cytokines, from 6.61 % to 21.24 %. PM 2.5 exposure was significantly associated with elevated levels of 9 cytokines and changed methylation at 7 CpG sites. Notably, PM 2.5 was significantly associated with GM-CSF, sCD40L, MCP-1, and FGF-2, as well as methylation in corresponding genes, but no mediation effect was observed. This trial suggested that indoor air filtration might attenuate the adverse effects of PM 2.5 exposure through changing cytokines and DNAm.",2020,The indoor PM 2.5 concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3,"['29 healthy young adults in Beijing, China', 'healthy young adults exposure to fine particulate matter']","['short-term air filtration intervention', 'sham indoor air filtration']","['GM-CSF, sCD40L, MCP-1, and FGF-2', 'Air filtration', 'Inflammatory cytokines and DNA methylation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]",29.0,0.181912,The indoor PM 2.5 concentration with true filtration was 67.8 % lower than sham filtration (13.8 μg/m 3,"[{'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Qisijing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Chunyue', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Bingxiao', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing, 100191, PR China; Key Laboratory of Molecular Cardiovascular Sciences of Ministry of Education, Peking University Health Science Center, Beijing, 100191, PR China. Electronic address: shaowei_wu@bjmu.edu.cn.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, 100069, PR China. Electronic address: zlilyepi@ccmu.edu.cn.'}]",Journal of hazardous materials,['10.1016/j.jhazmat.2020.122817'] 2312,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE. METHODS In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each. RESULTS At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period. CONCLUSION People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148'] 2313,32516765,"The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial.","INTRODUCTION Menopause is the termination of menstruation and fertility. Women commonly experience sleeping problems during the menopausal period. Aromatherapy is among the complementary therapies used to remedy sleeping problems. METHODS This study aims to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. This study was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). RESULTS For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001). CONCLUSION It was found that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.",2020,"For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001).","['Menopausal Women with Sleeping Problems', 'menopausal women through steam inhalation', 'women with sleep deprivation problems during menopause', '57 women, 27 of whom were subject to aromatherapy and 30 to a']","['placebo', 'Aromatherapy', 'Placebo', 'lavender oil']","['Sleep and Quality of Life', 'sleep and quality of life', 'Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL', 'total median MENQOL scores', 'sleep quality and quality of life', 'PSQI median scores']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0454515', 'cui_str': 'Steam inhalations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",57.0,0.102608,"For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001).","[{'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Gürler', 'Affiliation': 'Health Services Vocational School, Ahi Evran University, Kırşehir, Turkey.'}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Kızılırmak', 'Affiliation': 'Department of Gynaecology and Obstetrics Nursing, Semra and Vefa Küçük Health Science Faculty, Nevşehir Hacı Bektaş Veli University, Nevşehir, Turkey, aynur268@gmail.com.'}, {'ForeName': 'Mürüvvet', 'Initials': 'M', 'LastName': 'Baser', 'Affiliation': 'Department of Gynaecology and Obstetrics Nursing, Health Science Faculty, Erciyes University, Kayseri, Turkey.'}]",Complementary medicine research,['10.1159/000507751'] 2314,32516769,Amount of Dentifrice and Fluoride Concentration Influence Salivary Fluoride Concentrations and Fluoride Intake by Toddlers.,"The present study evaluated fluoride (F) concentrations in saliva of toddlers after brushing with dentifrices containing different F concentrations, applied in different quantities, and estimated F intake from toothbrushing. The study comprised a double-blind, crossover protocol, in which toddlers (n = 18, 2-3 years old) were randomly assigned into six groups, according to possible combinations of dentifrices (0/550/1,100 ppm F, as NaF) and amounts (rice grain, pea size, and transverse technique). Volunteers used a F-free dentifrice during 1 week. On the 7th day, saliva samples were collected before (baseline), and at 5/15/30/60 min after toothbrushing. All dentifrice expectorated after brushing was collected. F concentrations (saliva and expectorate) were determined with an ion-specific electrode. Data were submitted to ANOVA or Kruskal-Wallis test, followed by Fisher's LSD or Student-Newman-Keuls' tests (p <0.05). Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain). The highest AUC and salivary F at 5 min after brushing were achieved by 1,100 ppm F (pea size), followed by 550 ppm F (transversal technique). Regarding F intake, the highest values were observed for 550 ppm F (transversal technique), followed by 1,100 ppm F (pea size). It is possible to conclude that the amount of dentifrice and F concentration in the product significantly affected both salivary F concentrations and F intake during toothbrushing.",2020,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","['toddlers (n = 18, 2-3 years old', 'Toddlers']","['Dentifrice and Fluoride', 'F-free dentifrice', 'Brushing with 550 ppm F dentifrice (pea size or transversal technique']","['salivary F concentrations and F intake', 'F concentrations (saliva and expectorate']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0232515', 'cui_str': 'Spitting'}]",,0.0436303,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","[{'ForeName': 'Caio', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Alberto Carlos Botazzo', 'Initials': 'ACB', 'LastName': 'Delbem', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Mayra Frasson', 'Initials': 'MF', 'LastName': 'Paiva', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Zen', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Danelon', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Robson Frederico', 'Initials': 'RF', 'LastName': 'Cunha', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Juliano Pelim', 'Initials': 'JP', 'LastName': 'Pessan', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil, juliano.pessan@unesp.br.'}]",Caries research,['10.1159/000503780'] 2315,32516810,Effect of the proton-pump Inhibitor pantoprazole on MycoPhenolic ACid exposure in kidney and liver transplant recipienTs (IMPACT study): a randomized trial.,"BACKGROUND Mycophenolic acid (MPA) is widely utilized as an immunosuppressant in kidney and liver transplantation, with reports suggesting an independent relationship between MPA concentrations and adverse allograft outcome. Proton-pump inhibitors (PPIs) may have variable effects on the absorption of different MPA formulations leading to differences in MPA exposure. METHODS A multicentre, randomized, prospective, double-blind placebo-controlled cross-over study was conducted to determine the effect of the PPI pantoprazole on the MPA and its metabolite MPA-glucuronide (MPA-G) area under the curve (AUC) >12 h (MPA-AUC12 h) in recipients maintained on mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS). We planned a priori to examine separately recipients maintained on MMF and EC-MPS for each pharmacokinetic parameter. The trial (and protocol) was registered with the Australian New Zealand Clinical Trials Registry on 24 March 2011, with the registration number of ACTRN12611000316909 ('IMPACT' study). RESULTS Of the 45 recipients screened, 40 (19 MMF and 21 EC-MPS) were randomized. The mean (standard deviation) recipient age was 58 (11) years with a median (interquartile range) time post-transplant of 43 (20-132) months. For recipients on MMF, there was a significant reduction in the MPA-AUC12 h [geometric mean (95% confidence interval) placebo: 53.9 (44.0-65.9) mg*h/L versus pantoprazole: 43.8 (35.6-53.4) mg*h/L; P = 0.004] when pantoprazole was co-administered compared with placebo. In contrast, co-administration with pantoprazole significantly increased MPA-AUC12 h [placebo: 36.1 (26.5-49.2) mg*h/L versus pantoprazole: 45.9 (35.5-59.3) mg*h/L; P = 0.023] in those receiving EC-MPS. Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group. CONCLUSIONS The co-administration of pantoprazole substantially reduced the bioavailability of MPA in patients maintained on MMF and had the opposite effect in patients maintained on EC-MPS, and therefore, clinicians should be cognizant of this drug interaction when prescribing the different MPA formulations.",2020,"Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group. ","['recipients maintained on mycophenolate mofetil (MMF) or enteric-coated', 'kidney and liver transplant recipienTs (IMPACT study', '45 recipients screened, 40 (19 MMF and 21 EC-MPS']","['mycophenolate sodium (EC-MPS', 'proton-pump\xa0Inhibitor pantoprazole', 'pantoprazole', 'Mycophenolic acid (MPA', 'PPI pantoprazole', 'Proton-pump inhibitors (PPIs', 'Pantoprazole', 'placebo']","['MPA and its metabolite MPA-glucuronide (MPA-G) area under the curve (AUC', 'pharmacokinetic profiles of MPA-G', 'MPA-AUC12', 'MPA-AUC12\u2009h [geometric mean', 'MycoPhenolic ACid exposure', 'bioavailability of MPA']","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}]","[{'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid glucuronide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.35859,"Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group. ","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sunderland', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Department of Nephrology & Transplantation Services, Royal\xa0Adelaide Hospital, and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Sallustio', 'Affiliation': 'Discipline of Pharmacology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cervelli', 'Affiliation': 'Department of Pharmacy, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joyce', 'Affiliation': 'School of Biomedical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ooi', 'Affiliation': 'School of Biomedical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Jeffrey', 'Affiliation': 'Faculty of Health and Medical Sciences, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Chakera', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Gursharan', 'Initials': 'G', 'LastName': 'Dogra', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa111'] 2316,32516811,[Planning and design of European prospective randomized trial on the value of drain in parotidectomy].,"INTRODUCTION There are no valid clinical studies on the value of wound drains in parotid surgery. The aim of the current trial is to analyze the influence of the closed wound drain (redon) on the incidence of postoperative complications such as bleeding, wound healing problems, infection, as well as salivary cyst and fistula after superficial or partial partidectomy. METHODS A European-wide multicenter prospective randomized study was planned. The study protocol was prepared by the leading study center (ENT University Hospital Cologne) in cooperation with the ENT University Hospitals Jena and Göttingen. The calculation of the number of cases was carried out with G*Power. The study includes test persons with an indication for parotidectomy for a benign tumor without known coagulation disorder or ongoing anticoagulation. Preoperative randomization and data management is software-supported (REDCap 9.1.24, Vanderbilt University). RESULTS The study has been approved by the leading ethics committee in 10/2019 and is open since 04/2019. Currently, nine (9) ENT hospitals are participating in the study, 6 of them in Germany and 3 in Austria. Enrollment of patients is ongoing in 7 centers. With a calculated follow-up-to-treat population of 800 test persons, the planned duration of the study is 4 years. CONCLUSIONS The Redon-study is the first prospective randomized study worldwide to investigate the effect of a drain in parotidectomy. In order to achieve the recruitment goal within the planned time frame, the participation of further specialized study centers is needed. We also encourage all ENT physicians to make their patients aware of the Redon study, inform them about the possibility of participating in the study and refer them to one of the participating centers.",2020,The study protocol was prepared by the leading study center (ENT University Hospital Cologne) in cooperation with the ENT University Hospitals Jena and Göttingen.,"['nine (9) ENT hospitals are participating in the study, 6 of them in Germany and 3 in Austria', 'leading study center (ENT University Hospital Cologne) in cooperation with the ENT University Hospitals Jena and Göttingen', 'persons with an indication for parotidectomy for a benign tumor without known coagulation disorder or ongoing anticoagulation']",['closed wound drain (redon'],[],"[{'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0193317', 'cui_str': 'Parotidectomy'}, {'cui': 'C0086692', 'cui_str': 'Neoplasm, benign'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0679319', 'cui_str': 'Closed wound'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",[],,0.030101,The study protocol was prepared by the leading study center (ENT University Hospital Cologne) in cooperation with the ENT University Hospitals Jena and Göttingen.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Grosheva', 'Affiliation': 'HNO Uniklinik Köln, Medizinische Fakultät, University of Cologne, Köln, Germany.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Klußmann', 'Affiliation': 'HNO Uniklinik Köln, Medizinische Fakultät, University of Cologne, Köln, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Beutner', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Georg-August-Universität Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Formanek', 'Affiliation': 'HNO und Phoniatrie, Krankenhaus der Barmherzigen Brüder, Wien, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lill', 'Affiliation': 'Institut für Kopf- und Halserkrankungen, Evangelisches Krankenhaus Wien, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Laskawi', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Georg-August-Universität Göttingen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Zenk', 'Affiliation': 'Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Augsburg, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Pick', 'Affiliation': 'HNO Uniklinik Köln, Medizinische Fakultät, University of Cologne, Köln, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Erlacher', 'Affiliation': 'HNO und Phoniatrie, Krankenhaus der Barmherzigen Brüder, Wien, Austria.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Bemmer', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Georg-August-Universität Göttingen, Germany.'}, {'ForeName': 'Jovanna', 'Initials': 'J', 'LastName': 'Thielker', 'Affiliation': 'Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Universitätsklinikum Jena, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Jering', 'Affiliation': 'Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Augsburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Tostmann', 'Affiliation': 'Klinik für Hals-Nasen-Ohrenheilkunde, Georg-August-Universität Göttingen, Germany.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Guntinas-Lichius', 'Affiliation': 'Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Jena, Germany.'}]",Laryngo- rhino- otologie,['10.1055/a-1178-0800'] 2317,32505932,Audiological assessment of neonatal hyperbilirubinemia.,"OBJECT To evaluate the hearing of infants with history of neonatal hyperbilirubinemia using ABR. METHODS A prospective randomized study carried on 100 infants whose hearing was assessed by ABR. Infants were allocated into two groups; case group which involve 60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17 mg/dl and less than 30 mg/dl) and control group involve 40 healthy infants. Each group was divided into 3 groups based on their age i.e. ≤ 6 months, > 6-9 months &> 9-12 months. The evaluated variables were latency time & inter peak latency time. RESULTS The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave I did not show a significant difference between the two study groups (P > 0.05). The mean inter wave latencies I-III, I-V& III-V of ABR were significantly higher in the case group compared with the controls. There was a negative correlation between age and the studied variables. CONCLUSION Hyperbilirubinemia have an adverse effect on neonatal hearing which was reflected by ABR parameters of this study.",2020,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"['40 healthy infants', '60 infants with history of neonatal hyperbilirubinemia (bilirubin more than17', 'neonatal hyperbilirubinemia', '100 infants whose hearing was assessed by ABR', 'hearing of infants with history of neonatal hyperbilirubinemia using ABR']",[],"['mean latencies of wave III&V of ABR', 'mean latencies of wave', 'mean inter wave latencies I-III, I-V& III-V of ABR', 'latency time & inter peak latency time']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",100.0,0.0141002,The mean latencies of wave III&V of ABR were significantly higher in the case group compared with the controls (P < 0.001) while the mean latencies of wave,"[{'ForeName': 'Yasser Mohammad', 'Initials': 'YM', 'LastName': 'Mandour', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghader_massoud@yahoo.com.'}, {'ForeName': 'Mohamed Aly', 'Initials': 'MA', 'LastName': 'El Sayed', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: drmohamedalyelsayed@yahoo.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'El Sayed Morgan', 'Affiliation': 'Faculty of Medicine, Department of Audio Vestibular Medicine, Mansoura University, Mansoura Faculty of Medicine, Egypt. Electronic address: ashraf_morgan75@yahool.com.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Bassam', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: ghadeer_masoud@yahoo.com.'}, {'ForeName': 'Hamada', 'Initials': 'H', 'LastName': 'Fadl', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: fadl_hamada@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elrefae', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Benha University, Benha Faculty of Medicine, Egypt. Electronic address: refae_ahmed@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110126'] 2318,32506100,"Home Based Pulmonary Rehabilitation on Oxygenation Status, Dyspnea and Fatigue in Stable Patients with COPD.","Pulmonary rehabilitation (PR) program of a sufficient duration has impact on consequence of COPD. To evaluate the effects of combination of pursed lip breathing (PLB), diaphragmatic breathing (DB) and lower extremity endurance training (LEET) as part of PR program in stable patients with COPD on oxygenation status, dyspnea and fatigue. This prospective interventional study was performed in the Department of Physiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from July 2010 to June 2011 and was performed on 116 male stable moderate COPD patients aged 50 to 65 years. Among them, 56 patients were without PR (control group) and 60 patients were intervened with PR (experimental group). The experimental patients were advised to perform the home based PR program (PLB, DB and LEET) for 30 minutes duration per session at home twice per day, along with standard drug treatment of COPD for uninterrupted 60 days. The control patients continued their treatment of COPD with standard drug for successive 60 days were advised. To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups. Independent sample 't' test and paired Student's 't' test were done with SPSS software. In the interpretation of results, p value of <0.05 was considered as statistically significant. In the present study, we found less decrement of SpO₂ and less increment of level of dyspnea as well as level of fatigue after 6MWT in the COPD patients with PR on 60th day of follow up. The study reveals that oxygenation status, dyspnea and fatigue improve after execution of regular home based PR program in patients with moderate stable COPD.",2020,"To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups.","['patients with moderate stable COPD', '56 patients were without PR (control group) and 60 patients were intervened with PR (experimental group', 'stable patients with COPD on oxygenation status, dyspnea and fatigue', 'Stable Patients with COPD', 'Department of Physiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from July 2010 to June 2011 and was performed on 116 male stable moderate COPD patients aged 50 to 65 years']","['pursed lip breathing (PLB), diaphragmatic breathing (DB) and lower extremity endurance training (LEET', 'Pulmonary rehabilitation (PR) program', 'Home Based Pulmonary Rehabilitation', 'home based PR program (PLB, DB and LEET']","['Oxygenation Status, Dyspnea and Fatigue', 'PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale', 'oxygenation status, dyspnea and fatigue', 'level of dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}]",116.0,0.015404,"To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups.","[{'ForeName': 'N U', 'Initials': 'NU', 'LastName': 'Ahmed', 'Affiliation': 'Major (Dr) Mohammad Nesar Uddin Ahmed, Medical Officer, 21 Field Ambulance, Bogura Cantonment, Bogura, Bangladesh. E-mail ID: nesarj9@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Begum', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Suhana', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[] 2319,32506124,"A Randomized, Blinded, Prospective Clinical Study Comparing Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers for the Treatment of Perioral Rhytids.","BACKGROUND Perioral rhytids are a bothersome sign of aging for many patients. While multiple treatments exist, choosing an optimal modality may be difficult taking into consideration that rhytids in this region are fine and the anatomy dynamic. OBJECTIVE To compare the efficacy and safety, and patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk®) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance®) in reducing uperficial perioral rhytids. METHODS The study was double-blinded, and 48 subjects with moderate to severe superficial perioral rhytids were enrolled. Subjects were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right, or vice versa. Rhytid severity was measured by patients using a linear analog scale, and for investigators a validated 5-point scale, for 180 days following treatment. RESULTS Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL compared to CPM-HA and remained so at 180 days (p < 0.05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, while SP-HAL was associated with one post-inflammatory nodule and two occurrences of Tyndall effect. CONCLUSION While both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect.",2020,Investigator-reported scores for rhytid severity were significantly better for SP-HAL compared to CPM-HA and remained so at 180 days (p < 0.05).,"['Perioral Rhytids', '48 subjects with moderate to severe superficial perioral rhytids were enrolled']","['CPM-HA', 'small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk®) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance®', 'Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers']","['safety profiles', 'efficacy and safety, and patient satisfaction', 'Rhytid severity', 'perioral rhytid severity', 'rash and mild acne for CPM-HA, while SP-HAL', 'rhytid severity']","[{'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0720810', 'cui_str': 'Halotestin'}, {'cui': 'C1101698', 'cui_str': 'Restylane'}, {'cui': 'C0074529', 'cui_str': 'Silk'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C3711916', 'cui_str': 'belotero balance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0720810', 'cui_str': 'Halotestin'}]",,0.0557328,Investigator-reported scores for rhytid severity were significantly better for SP-HAL compared to CPM-HA and remained so at 180 days (p < 0.05).,"[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Polacco', 'Affiliation': ''}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Singleton', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Luu', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Maas', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa161'] 2320,32506135,Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: a Controlled Dietary Intervention Study.,"CONTEXT Although dietary potassium and sodium intake may influence calcium-phosphate metabolism, and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23) are unclear. OBJECTIVE Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters. DESIGN setting, participants: We performed a post-hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Pre-hypertensive individuals not using antihypertensive medication (n=36) received capsules containing potassium chloride (3 grams/day), sodium chloride (3 grams/day) or placebo. Linear mixed-effect models were used to estimate treatment effects. RESULTS Potassium supplementation increased plasma phosphate (from 1.10±0.19 to 1.15±0.19 mmol/L, P=0.004), in line with increase in tubular maximum of phosphate reabsorption (TmP/GFR; from 0.93±0.21 to 1.01±0.20 mmol/L, P<0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, [P=0.01]), without change in parathyroid hormone and 25(OH)-vitamin D3. Fractional calcium excretion decreased (from 1.25±0.50 to 1.11±0.46 %, P=0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02). Urinary and fractional calcium excretion increased (from 4.28±1.91 to 5.45±2.51 mmol/24 hrs, P<0.001, and from 1.25±0.50 to 1.44±0.54 %, P=0.004, respectively). CONCLUSIONS Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23.",2020,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).",['hypertensive individuals not using antihypertensive medication (n=36) received'],"['Potassium or Sodium Supplementation', 'sodium chloride', 'capsules containing potassium chloride', 'Potassium supplementation', 'dietary potassium and sodium intake', 'potassium and sodium intake', 'potassium or sodium supplementation', 'Sodium supplementation', 'placebo']","['parathyroid hormone and 25(OH)-vitamin D3', 'Fractional calcium excretion', 'bone mineral parameters, including FGF23', 'Mineral Homeostasis', 'Urinary and fractional calcium excretion', 'plasma calcium', 'bone mineral parameters', 'plasma phosphate', 'FGF23', 'plasma phosphate and decreased calcium excretion', 'tubular maximum of phosphate reabsorption', 'fractional calcium excretion']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}, {'cui': 'C0162800', 'cui_str': 'Dietary Potassium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1272114', 'cui_str': 'Plasma calcium level'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]",,0.11207,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Stanley M H', 'Initials': 'SMH', 'LastName': 'Yeung', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Gijsbers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Ineke J', 'Initials': 'IJ', 'LastName': 'Riphagen', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Gerjan', 'Initials': 'G', 'LastName': 'Navis', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'De Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa359'] 2321,32506227,"The efficacy in treatment of facial melasma with thulium 1927-nm fractional laser-assisted topical tranexamic acid delivery: a split-face, double-blind, randomized controlled pilot study.","This split-face, double-blind, randomized controlled study examines the efficacy of fractional thulium laser (FTL)-assisted delivery of topical tranexamic acid (TXA) compared with FTL alone as a treatment option for melasma. Forty-six adults with Fitzpatrick skin types III-V and recalcitrant melasma underwent four weekly treatments with fractional 1927-nm thulium laser on both sides of the face. Immediately after treatment, TXA was applied to one side of the face and normal saline solution (NSS) to the contralateral side as control under occlusion. Melanin index (MI), modified MASI (mMASI), and patients' self-assessed improvement scores were measured at baseline, 1 week, 4 weeks, and 3- and 6 months after the final treatment and were examined statistically with a paired sample t test with significance set at p ≤ 0.05. The majority of the participants (95.7%, n = 44) were female with Fitzpatrick skin type IV (82.6%) and a mean age of 48.0 ± 10.0 years. Twenty-nine individuals were able to be followed up until the 6-month assessment. Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides. By the 6th month, significant differences in MI and mMASI scores from baseline were still noted, except in the MI for controls. The patients' self-assessment showed similar patterns. No serious adverse events were reported for either group. A regimen of FTL-assisted delivery of TXA over a 4-week period is a safe and effective treatment option for melasma, producing significant improvement up to 3 months. Results further would suggest a repeat regimen every 3 months could be useful for treatment of recalcitrant melasma.",2020,"Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides.","['participants (95.7%, n = 44) were female with Fitzpatrick skin type IV (82.6%) and a mean age of 48.0 ± 10.0 years', 'facial melasma with thulium 1927-nm', 'melasma', 'Forty-six adults with Fitzpatrick skin types III-V and recalcitrant melasma', 'Twenty-nine individuals']","['fractional 1927-nm thulium laser', 'TXA', 'fractional thulium laser (FTL)-assisted delivery of topical tranexamic acid (TXA', 'fractional laser-assisted topical tranexamic acid delivery', 'normal saline solution (NSS', 'FTL alone', 'FTL']","['MI and mMASI scores', 'serious adverse events', ""Melanin index (MI), modified MASI (mMASI), and patients' self-assessed improvement scores""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0877233', 'cui_str': 'Assisted delivery'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",46.0,0.0463113,"Significant improvement from baseline was seen in both the MI and mMASI scores for both the TXA and control sides at 3 months, with no statistically significant difference between sides.","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand. rungsima.wan@mahidol.ac.th.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Sy-Alvarado', 'Affiliation': 'Section of Dermatology, Department of Medicine, Philippine General Hospital, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Poramin', 'Initials': 'P', 'LastName': 'Patthamalai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, 2 Pran-nok Road, Bangkok, 10700, Thailand.'}]",Lasers in medical science,['10.1007/s10103-020-03045-8'] 2322,32511251,Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea.,"BACKGROUND Anemia is the most common and serious cancer-related complication. This study aimed to evaluate the efficacy of administration of ferric carboxymaltose without erythropoiesis-stimulating agents for treating anemia in cancer patients. Moreover, we identified the biomarkers of hemoglobin response to predict the need for iron therapy. METHODS AND FINDINGS We enrolled patients with solid cancers who were treated at a single institute (Samsung Medical Center, South Korea), from April 2015 to July 2017, in this prospective single-arm Phase II clinical trial. Patients received intravenous ferric carboxymaltose (1,000 mg) infusion on the first day (visit 1) of treatment. The primary end point was the number of hemoglobin responders, defined as patients with an increase in hemoglobin level ≥ 1.0 g/dL from the baseline, a hemoglobin level ≥ 11.0 g/dL, or both, within an 8-week observation period (week 3, 6, or 8). Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit. Of the 103 recruited patients, 92 were eligible for analysis. The mean patient age was 57.3 ± 12.5 years, and 54.3% of the patients were women. The most common diagnoses were breast cancer (n = 23, 25.1%), lung cancer (n = 21, 22.9%), gastrointestinal cancer (n = 20, 20.9%), and lymphoma (n = 16, 17.7%). A hemoglobin response was observed in 36 (39.1%), 53 (57.6%), and 61 (66.3%) patients in the third, fifth, and eighth weeks, respectively. The mean increase in hemoglobin levels from the baseline to the end of treatment was 1.77 ± 1.30 g/dL. Baseline values of hepcidin (p = 0.008), total iron binding capacity (p = 0.014), ferritin (p = 0.048), and CRP (p = 0.044) were significantly different between the responder and nonresponder groups. Multiple logistic regression analysis for baseline anemia-related biochemical variable significantly associated with the hemoglobin response showed that only baseline hepcidin level was a significant factor for hemoglobin response (odds ratio = 0.95, 95% confidence interval 0.90-1.0, p = 0.045). Hemoglobin responders had significantly lower hepcidin levels than nonresponders (mean [±standard deviation], 13.45 [±14.71] versus 35.22 [±40.470 ng/ml]; p = 0.007). However, our analysis had some limitations such as the different patient characteristics in the studies that were included, institutional differences in the measurement of hepcidin level, and missing data on long-term safety. Therefore, our findings need further validation. CONCLUSIONS Intravenous ferric carboxymaltose (1,000 mg) monotherapy increases hemoglobin levels without serious adverse events in patients with cancer. Hepcidin is a useful biomarker for predicting iron requirement in cancer patients. TRIAL REGISTRATION Clinicaltrials.gov NCT02599012.",2020,"Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit.","['103 recruited patients, 92 were eligible for analysis', 'patients with cancer', 'The mean patient age was 57.3 ± 12.5 years, and 54.3% of the patients were women', 'cancer patients', 'chemotherapy-induced anemia', 'enrolled patients with solid cancers who were treated at a single institute (Samsung Medical Center, South Korea), from April 2015 to July 2017']","['Hepcidin', 'ferric carboxymaltose without erythropoiesis-stimulating agents', 'Intravenous ferric carboxymaltose', 'intravenous ferric carboxymaltose', 'intravenous iron treatment']","['CRP', 'lung cancer', 'hepcidin levels', 'gastrointestinal cancer', 'Efficacy', 'hemoglobin levels', 'total iron binding capacity', 'hemoglobin level', 'changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP', 'number of hemoglobin responders', 'hemoglobin response']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",103.0,0.0792099,"Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit.","[{'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ""Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul Won', 'Initials': 'CW', 'LastName': 'Jung', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University of School of Medicine, Seoul, South Korea.'}]",PLoS medicine,['10.1371/journal.pmed.1003091'] 2323,32511450,Protocol for a randomized controlled trial testing inhaled nitric oxide therapy in spontaneously breathing patients with COVID-19.,"Introduction the current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health. The number of infected patients is continuously increasing and the need for Intensive Care Unit admission ranges from 5 to 26%. The mortality is reported to be around 3.4% with higher values for the elderly and in patients with comorbidities. Moreover, this condition is challenging the healthcare system where the outbreak reached its highest value. To date there is still no available treatment for SARS-CoV-2. Clinical and preclinical evidence suggests that nitric oxide (NO) has a beneficial effect on the coronavirus-mediated acute respiratory syndrome, and this can be related to its viricidal effect. The time from the symptoms' onset to the development of severe respiratory distress is relatively long. We hypothesize that high concentrations of inhaled NO administered during early phases of COVID-19 infection can prevent the progression of the disease. Methods and analysis This is a multicenter randomized controlled trial. Spontaneous breathing patients admitted to the hospital for symptomatic COVID-19 infection will be eligible to enter the study. Patients in the treatment group will receive inhaled NO at high doses (140-180 parts per million) for 30 minutes, 2 sessions every day for 14 days in addition to the hospital care. Patient in the control group will receive only hospital care. The primary outcome is the percentage of patients requiring endotracheal intubation due to the progression of the disease in the first 28 days from enrollment in the study. Secondary outcomes include mortality at 28 days, proportion of negative test for SARS-CoV-2 at 7 days and time to clinical recovery. Ethics and dissemination The trial protocol has been approved at the Investigation Review Boards of Xijing Hospital (Xi'an, China) and The Partners Human Research Committee of Massachusetts General Hospital (Boston, USA) is pending. Recruitment is expected to start in March 2020. Results of this study will be published in scientific journals, presented at scientific meetings, and on related website or media in fighting this widespread contagious disease.",2020,"Introduction the current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health.","['Spontaneous breathing patients admitted to the hospital for symptomatic COVID-19 infection', 'spontaneously breathing patients with COVID-19']","['nitric oxide therapy', 'nitric oxide (NO']","['mortality at 28 days, proportion of negative test for SARS-CoV-2 at 7 days and time to clinical recovery', 'mortality', 'percentage of patients requiring endotracheal intubation due to the progression of the disease']","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.106312,"Introduction the current worldwide outbreak of Coronavirus disease 2019 (COVID-19) due to a novel coronavirus (SARS-CoV-2) is seriously threatening the public health.","[{'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University. Xi'an, Shaanxi, China.""}, {'ForeName': 'Binxiao', 'Initials': 'B', 'LastName': 'Su', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University. Xi'an, Shaanxi, China.""}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University. Xi'an, Shaanxi, China.""}, {'ForeName': 'Bijan Safaee', 'Initials': 'BS', 'LastName': 'Fakhr', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Luigi Giuseppe', 'Initials': 'LG', 'LastName': 'Grassi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Di Fenza', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gianni', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pinciroli', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Vassena', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Caio Cesar Araujo', 'Initials': 'CCA', 'LastName': 'Morais', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bellavia', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Spina', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berra', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",medRxiv : the preprint server for health sciences,['10.1101/2020.03.10.20033522'] 2324,32511534,Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2).,"INTRODUCTION Severe acute respiratory syndrome due to novel Coronavirus (SARS-CoV-2) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In has also shown in-vitro and clinical evidence that inhaled nitric oxide gas (iNO) has antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic COVID-19. This is a multicenter randomized controlled trial with 1:1 individual allocation. Patients will be blinded to the treatment. Methods and analysis. Intubated patients admitted to the intensive care unit with confirmed SARS-CoV-2 infection and severe hypoxemia will be randomized to receive inhalation of NO (treatment group) or not (control group). Treatment will be stopped when patients are free from hypoxemia for more than 24 hours. The primary outcome evaluates levels of oxygenation between the two groups at 48 hours. Secondary outcomes include rate of survival rate at 28 and 90 days in the two groups, time to resolution of severe hypoxemia, time to achieve negativity of SARS-CoV-2 RT-PCR tests. Ethics and dissemination. The study protocol has been approved by the Investigational Review Board of Xijing Hospital (Xian, China) and by the Partners Human Research Committee (Boston, USA). Recruitment will start after approval of both IRBs and local IRBs at other enrolling centers. Results of this study will be published in scientific journals, presented at scientific meetings, reported through flyers and posters, and published on related website or media in combating against this widespread contagious diseases. TRIAL REGISTRATION Clinicaltrials.gov. NCT04306393.",2020,"Secondary outcomes include rate of survival rate at 28 and 90 days in the two groups, time to resolution of severe hypoxemia, time to achieve negativity of SARS-CoV-2 RT-PCR tests.","['mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2', 'patients with hypoxic COVID-19', 'Intubated patients admitted to the intensive care unit with confirmed SARS-CoV-2 infection and severe hypoxemia']","['inhaled nitric oxide gas (iNO', 'Nitric Oxide']","['time to resolution of severe hypoxemia, time to achieve negativity of SARS-CoV-2 RT-PCR tests', 'rate of survival rate', 'levels of oxygenation', 'oxygenation']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.290613,"Secondary outcomes include rate of survival rate at 28 and 90 days in the two groups, time to resolution of severe hypoxemia, time to achieve negativity of SARS-CoV-2 RT-PCR tests.","[{'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Binxiao', 'Initials': 'B', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bellavia', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Di Fenza', 'Affiliation': ''}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Safaee Fakhr', 'Affiliation': ''}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gianni', 'Affiliation': ''}, {'ForeName': 'Luigi Giuseppe', 'Initials': 'LG', 'LastName': 'Grassi', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kacmarek', 'Affiliation': ''}, {'ForeName': 'Caio Cesar', 'Initials': 'CC', 'LastName': 'Araujo Morais', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pinciroli', 'Affiliation': ''}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Vassena', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berra', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.03.09.20033530'] 2325,32511687,Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials.,"Importance Accumulation of disability in multiple sclerosis may occur as relapse-associated worsening (RAW) or steady progression independent of relapse activity (PIRA), with PIRA regarded as a feature of primary and secondary progressive multiple sclerosis. Objective To investigate the contributions of relapse-associated worsening vs relapse-independent progression to overall confirmed disability accumulation (CDA) and assess respective baseline prognostic factors and outcomes of 2 treatments. Design, Setting, and Participants Analyses occurred from July 2015 to February 2020 on pooled data from the intention-to-treat population of 2 identical, phase 3, multicenter, double-blind, double-dummy, parallel-group randomized clinical trials (OPERA I and II) conducted between August 2011 and April 2015. In the trials, patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria, were randomized from 307 trial sites in 56 countries; resulting data were analyzed in the pooled data set. Interventions Participants were randomized 1:1 to receive 600 mg of ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a 3 times a week at a dose of 44 μg throughout a 96-week treatment period. Main Outcomes and Measures Confirmed disability accumulation was defined by an increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test), confirmed after 3 or 6 months, and classified per temporal association with confirmed clinical relapses (PIRA or RAW). Results In the pooled OPERA I and II population (1656 of 2096 eligible participants), baseline demographics and disease characteristics were similar for patients randomized to interferon β-1a vs ocrelizumab (mean [SD] age, 37.2 [9.2] vs 37.1 [9.2] years; 552 [66.6%] vs 541 women [65.4%]). After 96 weeks, 12-week composite CDA had occurred in 223 (29.6% by Kaplan-Meier estimate) randomized to interferon β-1a and 167 (21.1%) randomized to ocrelizumab; 24-week composite CDA had occurred in 170 (22.7%) taking interferon β-1a and 129 (16.2%) taking ocrelizumab. The PIRA events were the main contributors to 12-week and 24-week composite CDA after 96 weeks in patients treated with interferon β-1a (174 of 223 [78.0%] and 137 of 170 [80.6%], respectively) and ocrelizumab (147 of 167 [88.0%] and 115 of 129 [89.1%], respectively); a minority had CDA explained by RAW events (69 of 390 [17.7%] and 52 of 299 [17.4%], respectively). Very few patients with composite CDA experienced both RAW and PIRA events (17 of 390 [4.4%] for 12-week and 15 of 299 [5.0%] for 24-week composite CDA). Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events. Conclusions and Relevance Most disability accumulation in RMS is not associated with overt relapses. This indicates an underlying progression in this typical RMS population and challenges the current clinical distinction of relapsing and progressive forms of multiple sclerosis. Ocrelizumab was superior to interferon β-1a in preventing both RAW and PIRA. Trial Registration ClinicalTrials.gov Identifiers: OPERA I (NCT01247324) and OPERA II (NCT01412333).",2020,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events. ","['patients with relapsing multiple sclerosis (RMS), diagnosed using the 2010 revised McDonald criteria']","['ocrelizumab by intravenous infusion every 24 weeks or subcutaneous interferon β-1a', 'Ocrelizumab (vs interferon β-1a', 'interferon β-1a vs ocrelizumab', 'Ocrelizumab']","['CDA explained by RAW events', 'reduced risk of composite CDA', 'baseline demographics and disease characteristics', 'RAW and PIRA events', 'confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events', 'disability accumulation', 'increase in 1 or more of 3 measures (Expanded Disability Status Scale, timed 25-ft walk, or 9-hole peg test', 'clinical relapses (PIRA or RAW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4517480', 'cui_str': '0.78'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",2096.0,0.167426,"Ocrelizumab (vs interferon β-1a) was associated with reduced risk of composite CDA (hazard ratio [HR], 0.67) and confirmed PIRA (HR, 0.78) and RAW (HR, 0.47) events. ","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston, Houston.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Bernasconi', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Model', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shibeshih', 'Initials': 'S', 'LastName': 'Belachew', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Weill Institute for Neurosciences, University of California, San Francisco, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1568'] 2326,32511792,Prophylactic clipping is not effective in preventing post-polypectomy bleeding for <20-mm colon polyps: A multicenter open-label randomized controlled trial.,"BACKGROUND AND AIM Prophylactic clipping (PC) after polypectomy has the potential to prevent post-polypectomy bleeding (PPB). We aimed to evaluate the effectiveness of PC in preventing PPB for <20-mm polyps. METHODS This multicenter, open-labeled, randomized controlled trial conducted from December 2013 to June 2017 at 10 institutions randomly assigned 1080 patients with <20-mm colon polyps to the non-PC and PC groups. Allocation factors were institution, antiplatelet drug use, and polyp number. The primary endpoint was differences in PPB rates between the groups. The severity of PPB and post-procedure abdominal symptoms were also investigated. These endpoints in intention-to-treat (ITT) and per-protocol (PP) analyses were evaluated. RESULTS We investigated 1039 patients with 2960 lesions. There was no significant difference between the groups in characteristics including age, sex, hypertension, diabetes, hyperlipidemia, antiplatelet drug use, and lesion characteristics such as type and size. Excluding the clip used in the non-PC group, intraoperative bleeding, and deviation of protocol, 903 patients were investigated in PP analysis. There was no significant difference in the PPB rate between the non-PC and PC groups [2.7% vs. 2.3%, p=0.6973 (ITT analysis); 3.0 vs. 2.4%, p=0.7353 (PP analysis)]. Severe PPB (≥grade 3) was similar between the groups. Total procedure time was significantly shorter in the non-PC group than in the PC group (31 min vs. 36 min, p=0.0002). Post-procedure abdominal fullness was less common in the non-PC group than in the PC group (20.8% vs. 25.6%, p=0.0833). CONCLUSION PC is not effective in preventing post-polypectomy bleeding for <20-mm colon polyps. (UMIN000012163).",2020,"Total procedure time was significantly shorter in the non-PC group than in the PC group (31 min vs. 36 min, p=0.0002).","['1039 patients with 2960 lesions', 'from December 2013 to June 2017 at 10 institutions randomly assigned 1080 patients with <20-mm colon polyps to the non-PC and PC groups']","['PC', 'Prophylactic clipping', 'Prophylactic clipping (PC']","['intraoperative bleeding', 'PPB rates', 'Total procedure time', 'severity of PPB and post-procedure abdominal symptoms', 'PPB rate', 'Post-procedure abdominal fullness', 'intention-to-treat (ITT) and per-protocol (PP) analyses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0235318', 'cui_str': 'Fullness abdominal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",1080.0,0.158608,"Total procedure time was significantly shorter in the non-PC group than in the PC group (31 min vs. 36 min, p=0.0002).","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Ishihara', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Center, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Gastroenterology, Toyonaka Municipal Hospital, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Center, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Nakamatsu', 'Affiliation': 'Department of Gastroenterology, Toyonaka Municipal Hospital, Japan.'}, {'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Ogiyama', 'Affiliation': 'Department of Gastroenterology, Itami City Hospital, Japan.'}, {'ForeName': 'Shinjiro', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, Kansai Rosai Hospital, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterology, Japan Community Health care Organization Osaka Hospital, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterology, Sumitomo Hospital, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology, Otemae Hospital, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yakushijin', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka General Medical Center, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Iijima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Takehara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Japan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15134'] 2327,32511803,Improving outcomes among young adults with type 1 diabetes: the D1 Now randomized pilot study protocol.,"BACKGROUND Young adults (aged 18-25 years) living with type 1 diabetes mellitus often have sub-optimal glycaemic levels, which can increase their risk of long-term diabetes complications. Informed by health psychology theory and using a young adult-centred approach (public and patient involvement), we have developed a complex intervention, entitled D1 Now, to improve outcomes in this target group. The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations. AIMS To gather and analyse acceptability and feasibility data to allow us to (1) refine the D1 Now intervention, and (2) determine the feasibility of a definitive randomized controlled trial of the intervention. METHODS Diabetes clinics on the island of Ireland will be recruited and randomized to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be aged 18-25 years and living with type 1 diabetes for at least 12 months. RESULTS AND DISCUSSION Participant outcomes (influenced by a core outcome set) include change in HbA 1c , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes. These outcomes will be measured at baseline and after 12 months of follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study.",2020,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations. ","['Young adults (aged 18-25 years) living with type 1 diabetes mellitus', 'young adults with type 1 diabetes', 'Diabetes clinics on the island of Ireland will be recruited and randomized to a D1', 'aged 18-25 years and living with type 1 diabetes for at least 12 months']",[],"['change in HbA 1c , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.094398,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations. ","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Casey', 'Affiliation': 'Physical Activity for Health Cluster, Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, Galway, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Casey', 'Affiliation': 'School of Nursing and Midwifery, Galway, Ireland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'Health Economics and Policy Analysis Centre, Centre for Research in Medical Devices, Galway, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hobbins', 'Affiliation': 'Centre for Research in Medical Devices (Cúram) and Health Economics and Policy Analysis Centre (HEPAC), Galway, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Newell', 'Affiliation': 'School of Mathematics, Statistics and Applied Mathematics, Galway, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, Galway, Ireland.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Dinneen', 'Affiliation': 'School of Medicine, National University of Ireland Galway, Galway, Ireland.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14337'] 2328,32511829,The Acute Muscular Response to Passive Movement and Blood Flow Restriction.,"PURPOSE To compare the acute effects of passive movement combined with blood flow restriction (PM+BFR) to passive movement (PM) or blood flow restriction alone (BFR). METHODS 20 healthy participants completed: time control (TC), PM, BFR, and PM+BFR (one per leg, over 2 days; randomized). For PM, a dynamometer moved the leg through 3 sets of 15 knee extensions/flexions (90° at 45°/second). For BFR, a cuff was inflated to 80% arterial occlusion pressure on the upper leg. Measurements consisted of: anterior muscle thickness at 60% and 70% of the upper leg before and after (-0, -5, and -10 minutes) conditions, ratings of perceived effort and discomfort before conditions and after each set, and of the vastus lateralis during conditions. Data, presented as mean (SD), were compared using Bayesian RMANOVA, except for perceived effort and discomfort, which were compared using a Friedman's Test (non-parametric). RESULTS 60% [∆cm before-after-0: TC=0.04 (0.09), PM=-0.01 (0.15), BFR=0.00 (0.11), PM+BFR=0.01 (0.22)] and 70% [∆cm before-after-0: TC=0.01 (0.09), PM=-0.01 (0.15), BFR=0.02 (0.11), PM+BFR=-0.03 (0.22)] muscle thickness did not change. Perceived effort was greater than TC following PM (p=0.05) and PM+BFR (p=.001). Perceived discomfort was greater following BFR and PM+BFR compared to TC (all p≤0.002) and PM (all p≤0.010). Changes in deoxygenation [e.g. channel 1; ∆μM start set 1-end set 3: TC=0.9 (1.2), PM=-1.2 (1.9), BFR=10.3 (2.7), PM+BFR=10.3 (3.0)] were generally greater with BFR and PM+BFR (BF inclusion =1.210e+13). CONCLUSION Acute muscular responses to PM+BFR are not augmented over the effect of BFR alone.",2020,Perceived discomfort was greater following BFR and PM+BFR compared to TC (all p≤0.002) and PM (all p≤0.010).,['20 healthy participants completed'],['passive movement combined with blood flow restriction (PM+BFR) to passive movement (PM) or blood flow restriction alone (BFR'],"['Perceived discomfort', 'Acute Muscular Response to Passive Movement and Blood Flow Restriction', 'time control (TC), PM, BFR, and PM+BFR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",20.0,0.0243963,Perceived discomfort was greater following BFR and PM+BFR compared to TC (all p≤0.002) and PM (all p≤0.010).,"[{'ForeName': 'Joonsun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Applied Physiology Laboratory, School of Kinesiology and Nutrition, The University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Daphney M', 'Initials': 'DM', 'LastName': 'Stanford', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Buckner', 'Affiliation': 'USF Muscle Laboratory, Division of Exercise Science, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Jessee', 'Affiliation': 'Applied Human Health and Physical Function Laboratory, Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, University, MS, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12649'] 2329,32511900,Effects of Vitamin D on Apoptosis and Quality of Sperm in Asthenozoospermia.,"OBJECTIVE Vitamin D receptor (VDR) is expressed in human spermatozoa. However, the role of vitamin D (VD) in human male reproduction has not yet been clarified. In this study, effects of VD on sperm parameters and its apoptosis in asthenozoospermic and healthy men were evaluated. METHODS The study was carried out on discharged semen samples of 80 asthenozoospermic and healthy men. The samples were divided into control and experimental groups (received 20 µMol of VD). This study assessed sperm motility using the Makler chamber, their morphology by Diff quick, apoptosis and necrosis by Annexin-V and TUNEL assays, and their chromatin integrity was assessed by Aniline blue and Toluidine blue staining, according to WHO guidelines. RESULTS The results revealed that: 1) the total number of motile sperms was increased by VD in both groups, but it was only significant in the asthenozoospermia group. 2) The progressive motility was increased with significant difference in both groups.3) Morphology of sperm did not show any changes due to VD in any of the groups. 4) Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups. 5) The percentage of positive toluidine blue was significantly decreased after using VD in the asthenozoospermia group. CONCLUSION VD could improve motility, early apoptosis, and sperm necrosis, especially in asthenozoospermic men and it could be used for therapeutic opportunities.",2020,"Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups.","['asthenozoospermic and healthy men', 'discharged semen samples of 80 asthenozoospermic and healthy men']","['Vitamin D receptor (VDR', 'Vitamin D', 'vitamin D (VD']","['percentage of positive toluidine blue', 'progressive motility', 'motility, early apoptosis, and sperm necrosis', 'Early apoptosis and necrosis of sperms', 'total number of motile sperms', 'Apoptosis and Quality of Sperm in Asthenozoospermia']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444176', 'cui_str': 'Seminal fluid specimen'}]","[{'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]",,0.0152186,"Early apoptosis and necrosis of sperms were reduced in both groups, but the results of late apoptosis showed no statistical difference in these groups.","[{'ForeName': 'Mahin Taheri', 'Initials': 'MT', 'LastName': 'Moghadam', 'Affiliation': 'Cellular and Molecular Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Ghazal', 'Initials': 'G', 'LastName': 'Hosseini', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences,Ahvaz, Iran.'}, {'ForeName': 'Forouzan', 'Initials': 'F', 'LastName': 'Absalan', 'Affiliation': 'Department of anatomical sciences, Abadan School of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Mahmoud Hashemi', 'Initials': 'MH', 'LastName': 'Tabar', 'Affiliation': 'Department of Anatomical Sciences, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences,Ahvaz, Iran.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Nikbakht', 'Affiliation': 'Fertility, Infertility and Perinatology Center, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200009'] 2330,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes. OBJECTIVES We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL). METHODS 46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS. RESULTS There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion. CONCLUSIONS Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015'] 2331,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients. METHODS Eleven non-depleted patients with COPD (FEV 1 65.5 ± 4.3%) performed two EET (room-air or O 2 -Suppl-100%), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 hours after EET. RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4% vs. 400.1 ± 384.9%; p = 0.003). CONCLUSIONS O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1 65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO(2)Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475'] 2332,32512248,"Level of pain intensity, cytokine profiling and microbial load after photodynamic therapy in acute severe pericoronitis.","AIM We evaluated the efficacy of antimicrobial photodynamic therapy (A-PDT) in the reduction of pain intensity and performed cytokine profiling and measurement of microbiological parameters in patients with acute pericoronitis. METHODS Sixty patients with age range 14-19 years were randomized into two groups: 'A-PDT group' which received additional A-PDT with conventional protocol, and 'conventional protocol group' (CPG) without A-PDT. Present pain intensity (PPI) were investigated using McGill Pain Questionnaire (MPQ) and Visual Analogue Scale (VAS). Gingival crevicular fluid were sampled to evaluate the levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α) and quantified using enzyme-linked immunosorbent assay. Microbial plaque was collected to evaluate total counts of Porphyromonas gingivalis and Tannerella forsythia expressed as log colony forming unit (CFU)/mL. Level of pain intensity, cytokine profiling and microbial load were assessed at baseline (B0), and post treatment F 7 (Day 7) and F 14 (Day 14). RESULTS A total of 59 patients (30 CPG and 29 A-PDT) completed the clinical trial. Present pain intensity scores statistically significantly reduced from B 0 to F 7 in both treatment groups (p < 0.05). For VAS, both groups showed statistically significant reduction in pain scores at F 14 only when compared with baseline (p < 0.05). There was no inter-group significant difference at any time point for either pain scores (p > 0.05). Only TNF-α showed statistically significant reduction with A-PDT compared to CPG at both F 7 and F 14 . CPG group showed significant reduction for only T. forsythia at both follow-up points. The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7 and F 14 . CONCLUSION The results of this study indicate that A-PDT may be a reliable treatment option in pericoronitis for the reduction of TNF-α and microbial load. However, A-PDT does not have any effect in the reduction of pain.",2020,"The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7 and F 14 . ","['acute severe pericoronitis', 'Sixty patients with age range 14-19 years', '59 patients (30 CPG and 29 A-PDT) completed the clinical trial', 'patients with acute pericoronitis']","['photodynamic therapy', ""PDT group' which received additional A-PDT with conventional protocol, and 'conventional protocol group' (CPG) without A-PDT"", 'CPG', 'antimicrobial photodynamic therapy (A-PDT']","['pain scores', 'pain intensity scores', 'levels of interleukin (IL)-6 and tumor necrosis factor-alpha (TNF-α) and quantified using enzyme-linked immunosorbent assay', 'reduction of pain', 'microbial counts for P. gingivalis and T. forsythia', 'Level of pain intensity, cytokine profiling and microbial load', 'total counts of Porphyromonas gingivalis and Tannerella forsythia expressed as log colony forming unit (CFU)/mL. Level of pain intensity, cytokine profiling and microbial load', 'pain intensity and performed cytokine profiling and measurement of microbiological parameters', 'McGill Pain Questionnaire (MPQ) and Visual Analogue Scale (VAS', 'Present pain intensity (PPI']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031055', 'cui_str': 'Pericoronitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0341006', 'cui_str': 'Acute pericoronitis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",60.0,0.0549293,"The microbial counts for P. gingivalis and T. forsythia significantly reduced in A-PDT groups compared to CPG group at both F 7 and F 14 . ","[{'ForeName': 'Mohamed Farouk', 'Initials': 'MF', 'LastName': 'Elsadek', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia; Nutrition and Food Science Department, Helwan University, Cairo, Egypt. Electronic address: mofaelsadek2@gmail.com.'}, {'ForeName': 'Badreldin Mohamed', 'Initials': 'BM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Rayan M', 'Initials': 'RM', 'LastName': 'Eskandrani', 'Affiliation': 'Clinical Specialist in Restorative Dentistry, Department of Restorative Dentistry, Ministry of Health Riyadh, Riyadh, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101830'] 2333,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question. METHODS RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline. RESULTS 108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group. CONCLUSION Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy. REGISTRATION NUMBER ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014'] 2334,32517353,Silibinin and SARS-CoV-2: Dual Targeting of Host Cytokine Storm and Virus Replication Machinery for Clinical Management of COVID-19 Patients.,"COVID-19, the illness caused by infection with the novel coronavirus SARS-CoV-2, is a rapidly spreading global pandemic in urgent need of effective treatments. Here we present a comprehensive examination of the host- and virus-targeted functions of the flavonolignan silibinin, a potential drug candidate against COVID-19/SARS-CoV-2. As a direct inhibitor of STAT3-a master checkpoint regulator of inflammatory cytokine signaling and immune response-silibinin might be expected to phenotypically integrate the mechanisms of action of IL-6-targeted monoclonal antibodies and pan-JAK1/2 inhibitors to limit the cytokine storm and T-cell lymphopenia in the clinical setting of severe COVID-19. As a computationally predicted, remdesivir-like inhibitor of RNA-dependent RNA polymerase (RdRp)-the central component of the replication/transcription machinery of SARS-CoV-2-silibinin is expected to reduce viral load and impede delayed interferon responses. The dual ability of silibinin to target both the host cytokine storm and the virus replication machinery provides a strong rationale for the clinical testing of silibinin against the COVID-19 global public health emergency. A randomized, open-label, phase II multicentric clinical trial (SIL-COVID19) will evaluate the therapeutic efficacy of silibinin in the prevention of acute respiratory distress syndrome in moderate-to-severe COVID-19-positive onco-hematological patients at the Catalan Institute of Oncology in Catalonia, Spain.",2020,"COVID-19, the illness caused by infection with the novel coronavirus SARS-CoV-2, is a rapidly spreading global pandemic in urgent need of effective treatments.","['COVID-19 Patients', 'acute respiratory distress syndrome in moderate-to-severe COVID-19-positive onco-hematological patients at the Catalan Institute of Oncology in Catalonia, Spain']","['Silibinin and SARS-CoV-2', 'silibinin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0600334', 'cui_str': 'silybin'}]",[],,0.028084,"COVID-19, the illness caused by infection with the novel coronavirus SARS-CoV-2, is a rapidly spreading global pandemic in urgent need of effective treatments.","[{'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology (ICO), Dr. Josep Trueta Hospital of Girona, 17007 Girona, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Martin-Castillo', 'Affiliation': 'Unit of Clinical Research, Catalan Institute of Oncology, 17007 Girona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buxó', 'Affiliation': 'Girona Biomedical Research Institute, 17190 Salt, Girona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology (ICO), Dr. Josep Trueta Hospital of Girona, 17007 Girona, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Encinar', 'Affiliation': 'Institute of Research, Development and Innovation in Biotechnology of Elche (IDiBE) and Molecular and Cell Biology Institute (IBMC), Miguel Hernández University (UMH), 03202 Elche, Spain.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Menendez', 'Affiliation': 'Girona Biomedical Research Institute, 17190 Salt, Girona, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9061770'] 2335,32517382,Post-Exercise Recovery of Ultra-Short-Term Heart Rate Variability after Yo-Yo Intermittent Recovery Test and Repeated Sprint Ability Test.,"This study aimed to examine the agreement and acceptance of ultra-short-term heart rate (HR) variability (HRV UST ) measures during post-exercise recovery in college football players. Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study. The participants completed both a repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1) in a randomized order and separated by 7 days. Electrocardiographic signals (ECG) were recorded in a supine position 10 min before and 30 min after the exercise protocols. The HR and HRV data were analyzed in the time segments of baseline 5~10 min (Baseline), post-exercise 0~5 min (Post 1), post-exercise 5~10 min (Post 2), and post-exercise 25~30 min (Post 3). The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment. The correlation of time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio were calculated. The results showed that the HRV UST of LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio showed trivial to small effect sizes (ES) (-0.00~0.49), very large and nearly perfect interclass correlation coefficients (ICC) (0.74~0.95), and relatively small values of bias (RSA: 0.01~-0.12; YYIR1: -0.01~-0.16) to the HRV criterion in both exercise protocols. In addition, the HRV UST of LnLF, LnHF, and LnLF:LnHF showed trivial to small ES (-0.04~-0.54), small to large ICC (-0.02~0.68), and relatively small values of bias (RSA: -0.02~0.65; YYIR1: 0.03~-0.23) to the HRV criterion in both exercise protocols. Lastly, the 1-min LnSDNN:LnRMSSD ratio was significantly correlated to the 5-min LnLF:LnHF ratio with moderate~high level ( r = 0.43~0.72; p < 0.05) during 30-min post-exercise recovery. The post-exercise 1-min HRV assessment in LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio was acceptable and accurate in the RSA and YYIR1 tests, compared to the 5-min time segment of measurement. The moderate to high correlation coefficient of the HRV UST LnSDNN:LnRMSSD ratio to the HRV criterion LnLF:LnHF ratio indicated the capacity to facilitate the post-exercise shortening duration of HRV measurement after maximal anaerobic or aerobic shuttle running. Using ultra-short-term record of LnSDNN:LnRMSSD ratio as a surrogate for standard measure of LnLF:LnHF ratio after short-term bouts of maximal intensity field-based shuttle running is warranted.",2020,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment.","['college football players', 'Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study']",['repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1'],"['natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio', 'Electrocardiographic signals (ECG', 'agreement and acceptance of ultra-short-term heart rate (HR) variability', 'HRV UST ) measures', 'HR and HRV data', 'time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517489', 'cui_str': '1.08'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",25.0,0.0701879,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST and 5-min criterion (HRV criterion ) of each time segment.","[{'ForeName': 'Chin-Hwai', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Chien', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Crowley-McHattan', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore 2480, Australia.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114070'] 2336,32517389,"Intermediate Cervical Plexus Block in the Management of Persistent Postoperative Pain Post Carotid Endarterectomy: A Prospective, Randomized, Controlled, Clinical Trial.","BACKGROUND The mechanisms of persistent postoperative pain (PPP) with neuropathic features after carotid endarterectomy (CEA) are multifaceted and are incompletely understood. OBJECTIVES The aim of this research was to assess whether the ultrasound-guided (USG) intermediate cervical plexus block (ICPB) could provide better control of PPP and neuropathic disturbances (NPDs) after CEA than the USG superficial cervical plexus block (SCPB). STUDY DESIGN Prospective, randomized, controlled, clinical trial. SETTING This clinical trial was conducted at the SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy). METHODS Patients who were scheduled for primary CEA were chosen. In the experimental group, the USG-ICPB was performed unilaterally, at the level of the third cervical vertebra. The needle was inserted into the deep lamina of the deep fascia of the neck, between the posterior border of the middle scalene muscle and the anterior border of the posterior scalene muscle. Three milliliters saline solution was injected into the opening of the deep lamina, and 20 mL 0.375% levobupivacaine was injected. In the control group, the anesthetic target was located at the inferior border of the sternocleidomastoid muscle at the level of the third cervical vertebra. The needle was superficially inserted below the skin, and 2 to 3 mL saline solution was injected into the opening of the superficial lamina of the deep fascia of the neck. A total of 20 mL 0.375% isobaric levobupivacaine was subsequently injected.The primary outcome measure was the proportion of patients with PPP on movement and at rest 3 months after surgery. The secondary outcome measures were NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption. Adverse effects were also recorded. RESULTS A total of 98 consecutive patients were enrolled and randomized to receive either a USG-SCPB (control group, n = 49) or a USG-ICPB (experimental group, n = 49). The sensory blockade was longer in the experimental group. Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063). The proportions of patients with NPDs were not different between the groups, whereas the sizes of the areas of interest (cm2) were significantly different. LIMITATIONS A limitation of this study is that we assessed NPDs for only 3 months using the von Frey hair test and the Lindblom test without additional instrumental techniques. Additionally, there are many risk factors for NPDs after CEA. For this reason, another limitation of this research is that we neglected to consider the relationship between the choice of anesthetic block and the presence of these risk factors. CONCLUSIONS The USG-ICPB provided long-lasting analgesia during the postoperative period and might mitigate the development of NPDs, thereby decreasing the analgesic drug requirement. KEY WORDS Carotid endarterectomy, intermediate cervical plexus block, myofascial planes of neck, neuropathic disturbances, persistent postoperative pain, superficial cervical plexus blocks, ultrasound guidance, vascular disease.",2020,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","['98 consecutive patients', 'Patients who were scheduled for primary CEA were chosen', ""SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy""]","['Intermediate Cervical Plexus Block', 'carotid endarterectomy (CEA', 'levobupivacaine', 'ultrasound-guided (USG) intermediate cervical plexus block (ICPB', 'isobaric levobupivacaine', 'USG-SCPB (control group, n = 49) or a USG-ICPB']","['proportions of patients with pain', 'proportion of patients with PPP on movement', 'NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption', 'Adverse effects', 'sensory blockade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0068515', 'cui_str': 'neodymium pyrocatechin disulfonate'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]",98.0,0.0787637,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Petrucci', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Cofini', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pizzi', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Coletta', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Angelo Geremia', 'Initials': 'AG', 'LastName': 'Blasetti', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Necozione', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Fusco', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Marinangeli', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}]",Pain physician,[] 2337,32517435,Comparison of glucose degradation product and receptor levels in dıabetic and normal pregnancy.,"Objectives The aim of our study was to asses the diagnostic values of new biochemical markers which can be alternative to OGTT and determine the differences between our groups. Materials and Methods A total 180 women were included into this prospective randomized study. The patients were divided into three groups. All the women were screened with 50 gr and 100 gr GDM screening tests. All three groups were evaluated in terms of biochemical parameters such as serum human advanced glycation end products (AGEs) levels, carboxymethyl lysine (CML) levels and receptor for advanced glycation end product levels (RAGE/AGER), body mass index (BMI), age, fasting glucose levels, obstetrics' parameters and gestational age. Results Age found as statistically insignificant in the control group, impaired glucose tolerance group and gestational diabetes group. Whereas fasting glucose levels and BMI in 3 groups found as statistically significant. AGEs, CML, RAGE/AGER levels found as statistically significant (p=0,000). Conclusion In this study AGEs, CML, RAGE/AGER levels usage for diagnosis and screening of gestational diabetes investigated. In this study, we appointed that advanced glycation products significantly higher in impaired glucose tolerance and gestational diabetes cases.",2020,"All three groups were evaluated in terms of biochemical parameters such as serum human advanced glycation end products (AGEs) levels, carboxymethyl lysine (CML) levels and receptor for advanced glycation end product levels (RAGE/AGER), body mass index (BMI), age, fasting glucose levels, obstetrics' parameters and gestational age. ","['A total 180 women', 'dıabetic and normal pregnancy', 'All the women were screened with 50 gr and 100 gr GDM screening tests']",[],"['AGEs, CML, RAGE/AGER levels', ""biochemical parameters such as serum human advanced glycation end products (AGEs) levels, carboxymethyl lysine (CML) levels and receptor for advanced glycation end product levels (RAGE/AGER), body mass index (BMI), age, fasting glucose levels, obstetrics' parameters and gestational age"", 'fasting glucose levels and BMI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232989', 'cui_str': 'Normal pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}]",[],"[{'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C4508788', 'cui_str': 'carboxymethyllysine'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C3812151', 'cui_str': 'RAGE receptor protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0101725', 'cui_str': 'Receptor for Advanced Glycation Endproducts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]",180.0,0.0126504,"All three groups were evaluated in terms of biochemical parameters such as serum human advanced glycation end products (AGEs) levels, carboxymethyl lysine (CML) levels and receptor for advanced glycation end product levels (RAGE/AGER), body mass index (BMI), age, fasting glucose levels, obstetrics' parameters and gestational age. ","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Şimşek Tanin', 'Affiliation': 'Clinic of Obstetrics and Gynecology, Boğazlıyan State Hospital, Yozgat, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kara', 'Affiliation': 'Department of Obstetrics and Gynecology, Kırşehir Ahi Evran University Faculty of Medicine, Kırşehir, Turkey.'}, {'ForeName': 'Yaprak', 'Initials': 'Y', 'LastName': 'Engin-Üstün', 'Affiliation': 'Clinic of Obstetrics and Gynecology, Etlik Zübeyde Hanım Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ayşe Yeşim', 'Initials': 'AY', 'LastName': 'Göçmen', 'Affiliation': 'Department of Medical Biochemistry, Bozok University Faculty of Medicine, Yozgat, Turkey.'}, {'ForeName': 'Ethem Serdar', 'Initials': 'ES', 'LastName': 'Yalvaç', 'Affiliation': 'Department of Obstetrics and Gynecology, Bozok University Faculty of Medicine, Yozgat, Turkey.'}]",Journal of the Turkish German Gynecological Association,['10.4274/jtgga.galenos.2019.2020.0051'] 2338,32517453,[A Prospective Study of Da Vinci Surgical Robotic System with Chest Wall External Nursing Interventions].,"BACKGROUND Minimally invasive and rapid recovery are trends in surgical treatment of lung cancer, and Da Vinci Surgical Robotic System plays an important role in them. This study was planned to explore the effect of chest wall external nursing interventions on reducing postoperative thoracic drainage and promoting rapid recovery of patients. METHODS The patients who underwent robotic radical lung cancer resection in our hospital from November 2017 to April 2018were randomly divided into two groups. The control group received robotic radical lung cancer resection with abdominal bands wrapped around the chest. The experimental group underwent Da Vinci robotic radical lung cancer surgery and assisted chest wall external nursing interventions after surgery. RESULTS The total and average daily drainage of the experimental group were less than those of the control group. Both the extubation time and the hospitalization time were shorter than those of the control group, but there was no significant difference. The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference. For patients whose chest wall thickness is less than 4 cm, mirabilite external application can significantly reduce the average daily and total drainage volume, but there is no significant difference in extubation time and hospitalization time. CONCLUSIONS Chest wall external nursing interventions are beneficial to the recovery of patients undergoing Vinci robotic lung cancer surgery. Especially for patients with thinner chest wall. It can reduce postoperative drainage, shorten tube retention time and accelerate discharge. Further improvement is expected to achieve better clinical results.",2020,"The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference.","['patients', 'patients with thinner chest wall', 'patients undergoing Vinci robotic lung cancer surgery']","['chest wall external nursing interventions', 'Da Vinci robotic radical lung cancer surgery and assisted chest wall external nursing interventions after surgery', 'Da Vinci Surgical Robotic System with Chest Wall External Nursing Interventions', 'Chest wall external nursing interventions', 'robotic radical lung cancer resection with abdominal bands wrapped around the chest', 'robotic radical lung cancer resection']","['extubation time and the hospitalization time', 'postoperative drainage, shorten tube retention time and accelerate discharge', 'postoperative thoracic drainage', 'total and average daily drainage', 'average daily and total drainage volume', 'extubation time and hospitalization time', 'pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0110548,"The pain score in the second days after operation of the experimental group was slightly higher than that of the control group, with no significant statistical difference.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Meng', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Xinxing', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.101.07'] 2339,32517477,Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial.,"BACKGROUND Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). METHOD This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. RESULTS Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. CONCLUSION This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.",2020,"No serious harms were reported. ","['women with moderate to severe menopausal symptoms', 'Seventy participants were included in the study']","['acupuncture treatment', 'standardised acupuncture', 'standardised acupuncture approach']","['menopause-relevant outcomes', 'menopausal symptoms', 'DNS and MSSP scale scores', 'HF scale scores', 'validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",70.0,0.244172,"No serious harms were reported. ","[{'ForeName': 'Kamma Sundgaard', 'Initials': 'KS', 'LastName': 'Lund', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christine Winther', 'Initials': 'CW', 'LastName': 'Bang', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920280'] 2340,32517482,Impact of timing of intraaortic balloon counterpulsation on mortality in cardiogenic shock - a subanalysis of the IABP-SHOCK II trial.,"BACKGROUND Conflicting results exist on whether initiation of intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI) has an impact on outcome in this setting. Our aim was to assess the outcome of patients undergoing IABP insertion before versus after primary PCI in acute myocardial infarction complicated by cardiogenic shock. METHODS The IABP-SHOCK II-trial randomized 600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control. We analysed the outcome of patients randomized to the intervention group regarding timing of IABP implantation before or after PCI. RESULTS Of 600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support. We analysed the 275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure. IABP insertion was performed before PCI in 33 (12%) and after PCI in 242 (88%) patients. There were no differences in baseline arterial lactate ( p  = 0.70), Simplified Acute Physiology Score-II-score ( p  = 0.60) and other relevant baseline characteristics. No differences were observed for short- and long-term mortality (pre vs . post 30-day mortality: 36% vs . 37%, odds ratio 0.99, 95% confidence interval (CI) 0.47-2.12, p  = 0.99; one-year mortality: 56% vs . 48%, hazard ratio 1.08, 95% CI 0.65-1.80, p  = 0.76; six-year-mortality: 64% vs . 65%, hazard ratio 1.00, 95% CI 0.63-1.60, p  = 0.99). In multivariable Cox regression analysis timing of IABP-implantation was no predictor for long-term outcome (hazard ratio 1.08, 95% CI 0.66-1.78, p  = 0.75). CONCLUSIONS Timing of IABP-implantation pre or post primary PCI had no impact on outcome in patients with acute myocardial infarction complicated by cardiogenic shock.",2020,"There were no differences in baseline arterial lactate ( p  = 0.70), Simplified Acute Physiology Score-II-score ( p  = 0.60) and other relevant baseline characteristics.","['600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support', 'patients with acute myocardial infarction complicated by cardiogenic shock', '275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure', '600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control', 'patients undergoing']","['intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI', 'IABP implantation', 'intraaortic balloon counterpulsation', 'IABP insertion']","['IABP insertion', 'short- and long-term mortality', 'post 30-day mortality', 'Simplified Acute Physiology Score-II-score', 'baseline arterial lactate']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}]","[{'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",600.0,0.558127,"There were no differences in baseline arterial lactate ( p  = 0.70), Simplified Acute Physiology Score-II-score ( p  = 0.60) and other relevant baseline characteristics.","[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine), University Heart Centre Lübeck, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Ledwoch', 'Affiliation': 'Department of Cardiology, Pulmonology and Critical Care, München Klinik Neuperlach, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine), University Heart Centre Lübeck, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Thelemann', 'Affiliation': 'Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine), University Heart Centre Lübeck, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine), University Heart Centre Lübeck, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Pöss', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Centre Leipzig at University of Leipzig and Leipzig Heart Institute, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Centre Leipzig at University of Leipzig and Leipzig Heart Institute, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Centre Leipzig at University of Leipzig and Leipzig Heart Institute, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Werdan', 'Affiliation': 'Clinic for Internal Medicine III, University Hospital Halle (Saale), Martin-Luther University Halle-Wittenberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Centre Leipzig at University of Leipzig and Leipzig Heart Institute, Germany.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872620930509'] 2341,32517513,The effects of a dialogue-based intervention to promote psychosocial well-being after stroke: a randomized controlled trial.,"OBJECTIVE To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. DESIGN Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. SETTING Community. SUBJECTS Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group ( n  = 166) or control group ( n  = 156). INTERVENTIONS The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1-1½ hour sessions delivered during the first six months post-stroke. MAIN MEASURES The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. RESULTS The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: -0.74, 95% confidence interval (CI): -3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. CONCLUSION The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.",2020,The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.,"['The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group', 'Three-hundred and twenty-two adults (⩾18\u2009years) with stroke within the last four weeks', 'Community']","['dialogue-based intervention to promote psychosocial well-being', 'dialogue-based intervention']","['health-related quality of life, sense of coherence, or depression', 'emotional distress and anxiety or higher levels of health-related quality of life', 'Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire', 'General Health Questionnaire-28 (GHQ-28', 'mean (SE) GHQ-28 score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",322.0,0.103993,The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.,"[{'ForeName': 'Line Kildal', 'Initials': 'LK', 'LastName': 'Bragstad', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ellen Gabrielsen', 'Initials': 'EG', 'LastName': 'Hjelle', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Zucknick', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Department of Biostatistics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Unni', 'Initials': 'U', 'LastName': 'Sveen', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Thommessen', 'Affiliation': 'Department of Neurology, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Berit Arnesveen', 'Initials': 'BA', 'LastName': 'Bronken', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Martinsen', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Kitzmüller', 'Affiliation': 'Department of Health and Care Sciences, Faculty of Health Sciences, UiT, The Arctic University of Norway, Narvik, Norway.'}, {'ForeName': 'Margrete', 'Initials': 'M', 'LastName': 'Mangset', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kari Johanne', 'Initials': 'KJ', 'LastName': 'Kvigne', 'Affiliation': 'Department of Health and Nursing Sciences, Faculty of Social and Health Sciences, Inland Norway University of Applied Sciences, Elverum, Norway.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Sciences Research, School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'C Elizabeth', 'Initials': 'CE', 'LastName': 'Lightbody', 'Affiliation': 'School of Nursing, University of Central Lancashire, Lancashire, UK.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Kirkevold', 'Affiliation': 'Research Center for Habilitation and Rehabilitation Services and Models (CHARM), Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",Clinical rehabilitation,['10.1177/0269215520929737'] 2342,32517564,Exploring the Impact of Informal Rape Myth Education in a Nonstudent Sample.,"Sexual assault has come to the forefront in terms of prevention and education for many social institutions such as college campuses. However, with a growing body of research highlighting the importance and effectiveness of interventions, research examining the impact of sexual assault education (SAE) on altering rape myth acceptance (RMA) among nonstudent populations is severely lacking. This is particularly problematic when considering that the issue of sexual assault extends well beyond academia in the United States. Accordingly, this study aims to fill this gap by employing an experimental design with repeated measures. Using a sample of 137 nonstudents surveyed via Amazon's Mechanical Turk, participants were randomly assigned to a treatment (rape myth intervention) or control (unrelated video content) group. To detect changes in RMA after a short rape myth education intervention, pretest and posttest RMA scores were generated for all participants using an altered version of the Updated Illinois Rape Myth Adherence scale. The treatment video was roughly 10 min in length and constructed by the lead author for the current research. All participants were presented with common rape myths, and then, the treatment group was provided with information (e.g., available research and statistics) to ""debunk"" these myths, and ultimately decrease acceptance of myths. Analyses indicate support for a significant change in RMA scores from pretest to posttest in the treatment group, finding support for the use of informal rape myth education in altering immediate RMA scores of a nonstudent sample. The RMA difference scores were also examined through a demographic lens to determine if the inclusion could further explain score changes. Demographics were not deemed significant predictors. Limitations and implications are discussed.",2020,"Analyses indicate support for a significant change in RMA scores from pretest to posttest in the treatment group, finding support for the use of informal rape myth education in altering immediate RMA scores of a nonstudent sample.","[""137 nonstudents surveyed via Amazon's Mechanical Turk, participants""]",['treatment (rape myth intervention) or control (unrelated video content) group'],"['RMA scores', 'immediate RMA scores']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034668', 'cui_str': 'Forcible intercourse'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",137.0,0.0263505,"Analyses indicate support for a significant change in RMA scores from pretest to posttest in the treatment group, finding support for the use of informal rape myth education in altering immediate RMA scores of a nonstudent sample.","[{'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Reddy', 'Affiliation': 'Portland State University, OR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Portland State University, OR, USA.'}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Morczek', 'Affiliation': 'Nevada State College, Henderson, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520927496'] 2343,32517582,Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial.,"BACKGROUND AND PURPOSE Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source. METHODS Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily. RESULTS During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7-4.3]), East Asia region (HR, 2.5 [95% CI, 1.6-3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2-3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m 2 decrease, [95% CI, 1.0-1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin. CONCLUSIONS Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02313909.",2020,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","['Patients With Embolic Strokes of Undetermined Source', 'patients with recent embolic stroke of undetermined source', 'Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial) embolic stroke', '15 patients with intracerebral hemorrhage, 2 (13%) were fatal']","['rivaroxaban', 'rivaroxaban 15 mg daily with aspirin 100 mg daily']","['annualized rate of intracerebral hemorrhage', 'systolic blood pressure, and impaired renal function', 'systolic blood pressure', 'glomerular filtration rate', 'Distribution of bleeding sites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3247999', 'cui_str': 'rivaroxaban 15 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}]","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",15.0,0.431584,"The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2-18.0]).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulík', 'Affiliation': ""International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University Brno, Czech Republic (R.M.).""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eckstein', 'Affiliation': 'Department of Internal Medicine, University Hospital Basel, Switzerland (J.E.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rudilosso', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience, Hospital Clinic, Barcelona, Spain. (S.R.).'}, {'ForeName': 'Veroníca V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Department of Neurology and Psychiatry, Faculty of Medicine, Universidad del Desarrollo, Clínica Alemana de Santiago, Santiago, Chile (V.V.O.).'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Chamorro', 'Affiliation': 'Comprehensive Stroke Center, Department of Neuroscience, Hospital Clinic, Barcelona, Spain. (A.C.).'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Hospital de La Santa Creu Isant Pau, Barcelona, Spain (J.M.-F.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Imperial College London, United Kingdom (R.V.).'}, {'ForeName': 'Şerefnur', 'Initials': 'Ş', 'LastName': 'Öztürk', 'Affiliation': 'Department of Neurology, Selcuk University Faculty of Medicine, Turkey (S.O.).'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden (T.T.).'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Baylor College of Medicine, Houston, TX (W.F.P.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ (S.D.B.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).'}]",Stroke,['10.1161/STROKEAHA.119.027995'] 2344,32517596,Comparing Blended Learning with Faculty-Led Ultrasound Training: Protocol for a Randomised Controlled Trial (The SIGNATURE Trial).,"Background: Ultrasound is increasingly used in clinical practice as a bedside tool. As medical graduates first encounter the technique in early residency, ultrasound training needs to be integrated into the undergraduate curriculum. In Switzerland, abdominal ultrasound skills have been taught by a faculty-led, 21-hour course. However, this course does not have sufficient capacity to meet the increasing demand, and there have been doubts about its effectiveness as a teaching method. We therefore developed a 21-hour blended-learning course, comprising five hours of e-learning and 16 hours of near-peer tutoring. This study investigates whether this new teaching format is as good as, or superior to, the faculty-led method. Methods: The SIGNATURE study is an investigator-initiated, two-arm, randomised controlled trial, enrolling 152 medical students at the Universities of Bern, Fribourg and Zurich. Stratified by study site, students are 1:1 randomised to either the blended-learning course or the faculty-led 2.5-day ultrasound course. Students undergo a six-station objective structured clinical examination (OSCE) and complete an online questionnaire immediately after the course and 6 months later. Discussion: If demonstrated to be effective, the blended-learning course would allow an increase in the number of undergraduate medical students that can acquire ultrasound skills before starting their residencies.",2020,"If demonstrated to be effective, the blended-learning course would allow an increase in the number of undergraduate medical students that can acquire ultrasound skills before starting their residencies.","['enrolling 152 medical students at the Universities of Bern, Fribourg and Zurich', 'Discussion']",['blended-learning course or the faculty-led 2.5-day ultrasound course'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",[],152.0,0.0832832,"If demonstrated to be effective, the blended-learning course would allow an increase in the number of undergraduate medical students that can acquire ultrasound skills before starting their residencies.","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hari', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Kälin', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Walter', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Clinic of General Internal Medicine and Nephrology, Klinik Hirslanden Zurich, Switzerland.'}]",Praxis,['10.1024/1661-8157/a003497'] 2345,32517654,Impact of protein supplementation during endurance training on changes in skeletal muscle transcriptome.,"BACKGROUND Protein supplementation improves physiological adaptations to endurance training, but the impact on adaptive changes in the skeletal muscle transcriptome remains elusive. The present analysis was executed to determine the impact of protein supplementation on changes in the skeletal muscle transcriptome following 5-weeks of endurance training. RESULTS Skeletal muscle tissue samples from the vastus lateralis were taken before and after 5-weeks of endurance training to assess changes in the skeletal muscle transcriptome. One hundred and 63 genes were differentially expressed after 5-weeks of endurance training in both groups (q-value< 0.05). In addition, the number of genes differentially expressed was higher in the protein group (PRO) (892, q-value< 0.05) when compared with the control group (CON) (440, q-value< 0.05), with no time-by-treatment interaction effect (q-value> 0.05). Endurance training primarily affected expression levels of genes related to extracellular matrix and these changes tended to be greater in PRO than in CON. CONCLUSIONS Protein supplementation subtly impacts endurance training-induced changes in the skeletal muscle transcriptome. In addition, our transcriptomic analysis revealed that the extracellular matrix may be an important factor for skeletal muscle adaptation in response to endurance training. This trial was registered at clinicaltrials.gov as NCT03462381, March 12, 2018. TRIAL REGISTRATION This trial was registered at clinicaltrials.gov as NCT03462381.",2020,One hundred and 63 genes were differentially expressed after 5-weeks of endurance training in both groups (q-value< 0.05).,[],"['Protein supplementation', 'endurance training', 'protein supplementation', 'Endurance training']","['number of genes differentially expressed', 'skeletal muscle transcriptome']",[],"[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C3178810', 'cui_str': 'Transcriptomes'}]",,0.0548763,One hundred and 63 genes were differentially expressed after 5-weeks of endurance training in both groups (q-value< 0.05).,"[{'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Knuiman', 'Affiliation': 'Division of Human Nutrition, Wageningen University & Research, Stippeneng 4, 6708, WE, Wageningen, The Netherlands. P.Knuiman@leeds.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Hangelbroek', 'Affiliation': 'Division of Human Nutrition, Wageningen University & Research, Stippeneng 4, 6708, WE, Wageningen, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boekschoten', 'Affiliation': 'Division of Human Nutrition, Wageningen University & Research, Stippeneng 4, 6708, WE, Wageningen, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Division of Human Nutrition, Wageningen University & Research, Stippeneng 4, 6708, WE, Wageningen, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition, Wageningen University & Research, Stippeneng 4, 6708, WE, Wageningen, The Netherlands.'}]",BMC genomics,['10.1186/s12864-020-6686-x'] 2346,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective. METHODS A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups. RESULTS Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011'] 2347,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010'] 2348,32512314,Women's unmet needs in early labour: Qualitative analysis of free-text survey responses in the M@NGO trial of caseload midwifery.,"OBJECTIVE to analyse women's experiences of early labour care in caseload midwifery in Australia. DESIGN this study sits within a multi-site randomised controlled trial of caseload midwifery versus standard care. Participant surveys were conducted at 6-weeks and 6-months after birth. Free-text responses about experiences of care were subject to critical thematic analysis in NVivo 11 software. SETTING two urban Australian hospitals in different states. PARTICIPANTS women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial. INTERVENTIONS participants were randomised to caseload midwifery or standard care for antenatal, labour and birth and postpartum care. MEASUREMENTS AND FINDINGS The 6-week survey response rate was 58% (n = 1,019). The survey included five open questions about women's experiences of pregnancy, labour and birth, and postnatal care. Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories. The category of early labour contained data from 84 individual participants (caseload care n = 44; standard care n = 40). Descriptive themes were: (1) needing permission; (2) doing the 'wrong' thing; and (3) being dismissed. Analytic themes were: (1) Seeking: women wanting to be ""close to those who know what's going on""; and (2) Shielding: midwives defending resources and normal birth. KEY CONCLUSIONS Regardless of model of care, early labour care was primarily described in negative terms. This could be attributed to reporting bias, because women who were neutral about early labour care may not comment. Nevertheless, the findings demonstrate a gap in knowledge about early labour care in caseload midwifery models. IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.",2020,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","['two urban Australian hospitals in different states', 'Nine-hundred and one respondents (88%) provided free text comments which were coded to generate 10 categories', '84 individual participants (caseload care n\xa0=\xa044; standard care n\xa0=\xa040', ""Women's unmet needs in early labour"", ""women's experiences of early labour care in caseload midwifery in Australia"", ""women 18 years and over, with a singleton pregnancy, less than 24 weeks' pregnant, not planning a caesarean section or already booked with a care provider; were eligible to participate in the trial""]","['caseload midwifery versus standard care', 'caseload midwifery or standard care for antenatal, labour and birth and postpartum care']","['pregnancy, labour and birth, and postnatal care']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]",,0.0808094,"IMPLICATIONS FOR PRACTICE Maternity services that offer caseload midwifery are ideally placed to evaluate how early labour home visiting impacts women's experiences of early labour.","[{'ForeName': 'Jyai', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; School of Nursing and Midwifery, Griffith University, Meadowbrook, Queensland, Australia. Electronic address: jyai.allen@griffith.edu.au.'}, {'ForeName': 'Bec', 'Initials': 'B', 'LastName': 'Jenkinson', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia. Electronic address: bec.jenkinson@mater.uq.edu.au.'}, {'ForeName': 'Sally K', 'Initials': 'SK', 'LastName': 'Tracy', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia. Electronic address: sally.tracy@sydney.edu.au.""}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Hartz', 'Affiliation': ""Midwifery and Women's Health Research Unit, University of Sydney, Royal Hospital for Women, Randwick, New South Wales, Australia; College of Nursing and Midwifery, Charles Darwin University, Sydney Campus, New South Wales, Australia. Electronic address: donna.hartz@cdu.edu.au.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': ""Department of Paediatrics and Child health Westmead Children's Clinical School, The University of Sydney, Westmead, New South Wales, Australia; Westmead Neonatal Intensive Care Unit, Westmead Hospital, Western Sydney Local Health District, New South Wales, Australia. Electronic address: mark.tracy@sydney.edu.au.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Mater Research Institute-The University of Queensland, Brisbane, Queensland, Australia; Molly Wardaguga Research Centre, College of Nursing and Midwifery, Charles Darwin University, Queensland, Australia. Electronic address: sue.kildea@cdu.edu.au.'}]",Midwifery,['10.1016/j.midw.2020.102751'] 2349,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139'] 2350,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking. METHODS We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions. FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation. INTERPRETATION Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809'] 2351,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa. METHODS In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality. FINDINGS 2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10 copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10 copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant. INTERPRETATION In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era. FUNDING This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815'] 2352,32512782,"Further Evidence of Benefits to Mood and Working Memory from Lipidated Curcumin in Healthy Older People: A 12-Week, Double-Blind, Placebo-Controlled, Partial Replication Study.","Curcumin (a flavonoid isolated from turmeric) affects several processes involved in neurocognitive aging. We have previously reported that short term (4-weeks) administration of a highly bioavailable curcumin preparation (Longvida©) improved working memory and reduced fatigue and stress reactivity in a healthy older cohort. The present trial (ACTRN12616000484448) was a partial replication study, evaluating similar effects at 4 and 12-weeks Longvida© supplementation. A double-blind, placebo-controlled, parallel-groups trial was conducted. Eighty participants aged 50-80 years (mean = 68.1, SD = 6.34) were randomised to receive Longvida© (400 mg daily containing 80 mg curcumin) or a matching placebo. Assessment took place at baseline then following 4 and 12 weeks treatment. Outcome measures included cognitive performance, mood and biomarkers. Compared with placebo, curcumin was associated with several significant effects. These included better working memory performance at 12-weeks (Serial Threes, Serial Sevens and performance on a virtual Morris Water Maze), and lower fatigue scores on the Profile of Mood States (POMS) at both 4 and 12-weeks, and of tension, anger, confusion and total mood disturbance at 4-weeks only. The curcumin group had significantly elevated blood glucose. These results confirm that Longvida© improves aspects of mood and working memory in a healthy older cohort. The pattern of results is consistent with improvements in hippocampal function and may hold promise for alleviating cognitive decline in some populations.",2020,The curcumin group had significantly elevated blood glucose.,"['healthy older cohort', 'Healthy Older People', 'Eighty participants aged 50-80 years (mean = 68.1, SD = 6.34']","['Longvida© (400 mg daily containing 80 mg curcumin) or a matching placebo', 'Placebo', 'highly bioavailable curcumin preparation (Longvida©', 'placebo']","['working memory and reduced fatigue and stress reactivity', 'working memory performance', 'elevated blood glucose', 'hippocampal function', 'tension, anger, confusion and total mood disturbance', 'cognitive performance, mood and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",80.0,0.539035,The curcumin group had significantly elevated blood glucose.,"[{'ForeName': 'Katherine H M', 'Initials': 'KHM', 'LastName': 'Cox', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipingas', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Kaylass', 'Initials': 'K', 'LastName': 'Poorun', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Hawthorn, Victoria 3122, Australia.'}]",Nutrients,['10.3390/nu12061678'] 2353,32512785,Changes in Muscle Contractile Properties after Cold- or Warm-Water Immersion Using Tensiomyography: A Cross-Over Randomised Trial.,"Muscle contractile properties in clinical practice are often measured using either subjective scales or high-cost, inaccessible equipment. In this randomised cross-over study, we aimed to explore the use of tensiomyography (TMG) to assess changes in muscle contractile properties after cold- and warm-water immersion. The muscle contractile properties of the biceps femoris (BF) were assessed using TMG in 12 healthy active men (mean age 23 ± 3 years, Body Mass Index 22.9 ± 1.3 kg/m 2 ) before and after a 20-min warm- or cold-water immersion over a period of 40 min. Muscle displacement (Dm) and contraction time (Tc) were registered as the main variables of the study. There was a significant condition by time interaction for Dm ( p < 0.01). Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01). No significant effect was found for Tc. Our results indicate that muscle contractile properties are affected by water temperature and time after the immersion; therefore, these factors should be taken into account when water-immersion is used as a recovery strategy.",2020,"Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01).","['12 healthy active men (mean age 23 ± 3 years, Body Mass Index 22.9 ± 1.3 kg/m 2 ) before and after a 20-min warm- or cold-water immersion over a period of 40 min']","['tensiomyography (TMG', 'Cold- or Warm-Water Immersion Using Tensiomyography']","['Muscle displacement (Dm) and contraction time (Tc', 'Muscle Contractile Properties']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",12.0,0.0264037,"Post hoc analysis showed that, compared to the baseline, there was an increase in Dm 40 min after warm-water immersion ( p < 0.01) and a decrease at 10 min after cold-water immersion ( p < 0.01).","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mur Gimeno', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, 47921 Rimini, Italy.'}, {'ForeName': 'Georgian', 'Initials': 'G', 'LastName': 'Badicu', 'Affiliation': 'Department of Physical Education and Special Motricity, University Transilvania of Brasov, 500068 Brasov, Romania.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Castizo-Olier', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Palomera-Fanegas', 'Affiliation': 'Unitat de Recerca i Bioestadística, Consorci Sanitari del Maresme, 08304 Mataró, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Sebio-Garcia', 'Affiliation': 'School of Health Sciences, TecnoCampus, Pompeu Fabra University, 08302 Mataró, Spain.'}]","Sensors (Basel, Switzerland)",['10.3390/s20113193'] 2354,32512862,Effect of Serum SPARC Levels on Survival in Patients with Digestive Tract Cancer: A Post Hoc Analysis of the AMATERASU Randomized Clinical Trial.,"Observational studies suggest that physical activity may improve, whereas sarcopenia may worsen the survival of cancer patients. It has been suggested that secreted protein acidic and rich in cysteine (SPARC), one of the myokines that is secreted into the bloodstream by muscle contraction, has tumor-suppressive effects. Based on the hypothesis that serum SPARC level may be a potential prognostic biomarker, a post hoc analysis of the AMATERASU randomized, double-blind, placebo-controlled trial of postoperative oral vitamin D supplementation (2000 IU/day) in patients with stage I-III digestive tract cancer from the esophagus to the rectum (UMIN000001977) was conducted with the aim of exploring the association between serum SPARC levels after operation and survival. On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05; p = 0.007), whereas there were no significant associations with other outcomes including recurrence. However, on the same multivariate analyses, sarcopenia was not a risk factor for death and/or relapse. These results suggest that serum SPARC levels may be a potential biomarker for death but not cancer relapse.",2020,"On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05; p = 0.007), whereas there were no significant associations with other outcomes including recurrence.","['Patients with Digestive Tract Cancer', 'patients with stage I-III digestive tract cancer from the esophagus to the rectum (UMIN000001977']","['Serum SPARC Levels', 'postoperative oral vitamin D supplementation', 'placebo']","['recurrence', 'serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",,0.378942,"On multivariate analyses adjusting serum 25-hydroxyvitamin D, vitamin D supplementation, sarcopenia, body mass index, age, sex, cancer loci, stage, and adjuvant chemotherapy, patients with SPARC levels lower than the median level had a significantly higher risk for death than those with higher levels (hazard ratio, 2.25; 95% confidence interval, 1.25-4.05; p = 0.007), whereas there were no significant associations with other outcomes including recurrence.","[{'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Akutsu', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo 105-8461, Japan.'}, {'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Ito', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Mitsuo', 'Initials': 'M', 'LastName': 'Narita', 'Affiliation': 'Department of Radiology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ohdaira', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi 329-2763, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Urashima', 'Affiliation': 'Division of Molecular Epidemiology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo 105-8461, Japan.'}]",Cancers,['10.3390/cancers12061465'] 2355,32512930,The Development and Effectiveness of a Clinical Training Violence Prevention Program for Nursing Students.,"The study aimed to develop and evaluate a violence prevention program for nursing students to improve communication self-efficacy, problem-focused coping style, emotion-focused coping style, and the ability to cope with violence. Using an eight-session violence prevention program, the study was designed as quasi experimental, with a pretest, posttest, and follow-up assessment with a nonequivalent control group. Nursing students from the fourth year of a university were selected as participants; 22 students were assigned to the experimental group and 23 to the control group. Data analysis included Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA. Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group. Thus, the workplace violence prevention program was effective for nursing students.",2020,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group.","['Nursing students from the fourth year of a university were selected as participants; 22 students', 'nursing students', 'Nursing Students']","['Clinical Training Violence Prevention Program', 'workplace violence prevention program', 'violence prevention program']","['coping style', ""Chi-square, Fisher's exact test, Levene's Test, Mann-Whitney U-test, and repeated measures ANOVA"", 'ability to cope with violence', 'intra-individual and interaction effects for the emotion-focused coping style']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658335', 'cui_str': 'Workplace Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",22.0,0.0137831,"Results showed that the experimental group showed significantly higher posttest scores for the problem-focused coping style (F = 20.77, p < 0.001), intra-individual and interaction effects for the emotion-focused coping style (F = 12.03, p < 0.001), and the ability to cope with violence (U = 70, p < 0.001) than the control group.","[{'ForeName': 'Yunhwa', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'Department of Nursing and Kyongbuk Science College, Gyeongsangbuk-do 39913, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Keimyung University, Daegu 42601, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114004'] 2356,32512963,"[Influences of acute hypervolemic hemodilution on serum levels of S-100β protein, NSE and POCD in elderly patients with spinal surgery].","OBJECTIVE To explore the influences of acute hypervolemic hemodilution(AHH) on serum levels of S-100β protein, neuron specific enolase(NSE) and postoperative cognitive dysfunction POCD in elderly patients with spinal surgery. METHODS A total of 80 cases elderly patients requiring elective spinal operation were divided into AHH group and C group according to random digits table, 40 cases in each group, with ASA grade I-II. The patients in AHH group were infused 6% hydroxyethyl starch 130/0.4 at a rate of 20 ml/min after anesthesia induction, and blood volume increased by about 20%, the patients in C group were not received AHH, anesthesia and surgical methods were the same as those in AHH group. Intraoperative blood volume, allogeneic blood transfusion and urine volume were recorded. Mean arterial pressure(MAP), heart rate(HR), central venous pressure(CVP) at preoperative 1 d, 1 h after the start of surgery, end of operation, 12 h after surgery were observed. Arterial blood oxygen content (CaO₂), venous blood oxygen content (CjvO₂), arteriovenous oxygen content difference (Da-jvO₂), and cerebral oxygen uptake(CERO₂) were measured at 1 d before surgery, 15 min after surgery, 45 min after surgery, end of surgery. Mini-mental state examination(MMSE) score and serum levels of S-100β protein, NSE were measured at 1 d before surgery, 1, 3, 7 d after surgery. POCD rates of two groups were recorded. RESULTS Intraoperative blood loss and allogeneic blood transfusion in AHH group was significantly lower than those in C group( P <0.05), and the urine volume was significantly higher than that in C group ( P <0.05). Compared with preoperative 1 day, MAP was decreased and CVP was increased at end of surgery in AHH group, compared with C group at the same time, MAP was lower and CVP was higher in AHH group, but both were in normal range. Compared with preoperative 1 day and C group, the levels of Da-jvO₂ and CERO₂ in AHH group was decreased at 15, 45 min after the start of the operation and end of surgery( P <0.05). Compared with preoperative 1 day, MMSE scores of two groups at 1 day after surgery was decreased ( P <0.05), the levels of S-100β protein and NSE were increased( P <0.05), and restored at 3, 7 days after surgery. There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05). There was no statistical difference in POCD rate between two groups( P >0.05). CONCLUSIONS AHH can significantly reduce intraoperative blood loss and blood transfusion in elderly patients with spinal surgery, and decrease the levels of S-100β protein and NSE, does not increase the risk of the occurrence of POCD.",2019,"There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05).","['elderly patients with spinal surgery', '80 cases elderly patients requiring elective spinal operation']","['hydroxyethyl starch', 'acute hypervolemic hemodilution', 'acute hypervolemic hemodilution(AHH']","['Intraoperative blood loss and allogeneic blood transfusion', 'Mini-mental state examination(MMSE) score and serum levels of S-100β protein, NSE', 'levels of S-100β protein and NSE', 'serum levels of S-100β protein, NSE and POCD', 'Mean arterial pressure(MAP), heart rate(HR), central venous pressure(CVP', 'Arterial blood oxygen content (CaO₂), venous blood oxygen content (CjvO₂), arteriovenous oxygen content difference (Da-jvO₂), and cerebral oxygen uptake(CERO₂', 'POCD rates', 'MMSE scores', 'blood volume', 'MMSE scores, the levels of S-100β protein, NSE', 'intraoperative blood loss and blood transfusion', 'levels of Da-jvO₂ and CERO₂', 'CVP', 'urine volume', 'Intraoperative blood volume, allogeneic blood transfusion and urine volume', 'POCD rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0185908', 'cui_str': 'Operative procedure on spinal structure'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0444466', 'cui_str': 'Central venous'}, {'cui': 'C0042486', 'cui_str': 'Venous pressure'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",80.0,0.0408016,"There was statistical difference in MMSE scores, the levels of S-100β protein, NSE at 1 day after surgery between two groups ( P <0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China; qw6654359@163.com.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Qi', 'Affiliation': 'Department of Bone Surgery, the Second Hospital of Bazhou City, Bazhou 065700, Hebei, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.3969/j.issn.1003-0034.2019.10.010'] 2357,32512985,The efficacy and complications of several bleaching techniques in patients after fixed orthodontic therapy. A randomized clinical trial.,"This study aimed to evaluate the efficacy and complications of several bleaching methods in patients with discolored teeth after orthodontic treatment. This randomized clinical trial involved 60 volunteers (31 women, 29 men) aged 14 to 30 years, who finished fixed orthodontic therapy at least three months before the study commencement and complained of discoloration on upper front teeth. The subjects were divided into four groups by treatment. The patients in group 1 received home bleaching, whereas those in groups 2 to 4 underwent in-office bleaching using a diode laser, a plasma arc and no light source, respectively. Tooth color was measured at baseline, one hour after the end of the bleaching procedure, and one week later, and the color alteration between different stages was compared among the groups. The severity of tooth sensitivity and the occurrence of other post-treatment complications were recorded. The color change between baseline and one week after treatment was greatest in the home-bleaching and the laser-assisted bleaching groups, and lowest in the plasma-arc bleaching group, although the difference between the groups was not significant (p > 0.05). Tooth sensitivity over 24 hours after bleaching was lowest in subjects who had undergone laser-assisted bleaching and highest in those who had received in-office bleaching without light (p < 0.05). All methods were effective in managing tooth discoloration after orthodontic treatment. Home bleaching produced favorable color alteration. Amongst the in-office approaches, laser-assisted bleaching should be considered as the best option, as it produced effective results with lowest tooth sensitivity and over a shorter period of time.",2020,"The color change between baseline and one week after treatment was greatest in the home-bleaching and the laser-assisted bleaching groups, and lowest in the plasma-arc bleaching group, although the difference between the groups was not significant (p > 0.05).","['patients with discolored teeth after orthodontic treatment', '60 volunteers (31 women, 29 men) aged 14 to 30 years, who finished fixed orthodontic therapy at least three months before the study commencement and complained of discoloration on upper front teeth', 'patients after fixed orthodontic therapy']","['home bleaching', 'office bleaching using a diode laser, a plasma arc and no light source, respectively']","['severity of tooth sensitivity and the occurrence of other post-treatment complications', 'favorable color alteration', 'Tooth sensitivity', 'managing tooth discoloration', 'Tooth color']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0181633', 'cui_str': 'Light source'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}]",60.0,0.0254742,"The color change between baseline and one week after treatment was greatest in the home-bleaching and the laser-assisted bleaching groups, and lowest in the plasma-arc bleaching group, although the difference between the groups was not significant (p > 0.05).","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ahrari', 'Affiliation': 'Associate Professor of Orthodontics, Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Akbari', 'Affiliation': 'Professor of Restorative and Cosmetic Dentistry, Dental Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamideh Sadat', 'Initials': 'HS', 'LastName': 'Mohammadipour', 'Affiliation': 'Assistant Professor of Restorative and Cosmetic Dentistry, Dental Materials Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fallahrastegar', 'Affiliation': 'Dentist, Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Salehe', 'Initials': 'S', 'LastName': 'Sekandari', 'Affiliation': 'Postgraduate Student, Department of Restorative and Cosmetic Dentistry, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Swiss dental journal,[] 2358,32513018,The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial.,"OBJECTIVES To evaluate and compare the efficacy of high-intensity laser therapy (HILT) and low-level laser therapy (LLLT) for plantar fasciitis. DESIGN A participant blind randomized controlled trial with parallel group design and an active comparator with follow-up at four weeks. SETTINGS Outpatient, University hospital. SUBJECTS Unilateral plantar fasciitis participants ( n  = 102) were randomly assigned into two groups. Recruitment period was from January 2017 to April 2019. INTERVENTIONS Interventions included eight sessions of laser therapy over three weeks and single session of patient education. The HILT group ( n  = 51) received HILT and the LLLT group ( n  = 51) received LLLT. MAIN MEASURES Primary outcomes: visual analogue scale; secondary outcomes: pressure algometry, sonography of plantar fascia thickness (time frame: baseline to three-week and four-week follow-up) and numeric rating scale (0%-100%) for opinion of participants on effect of treatment (time frame: three weeks). Data presented: mean (SD) or n (%). RESULTS There was no statistically significant difference between the groups according to visual analogue scale (pain in general reduction in three weeks: 2.57(3.45) vs. 2.88(3.28) cm), pressure algometry (pain threshold difference between healthy and affected heel reduction in three weeks: 1.80(6.39) vs. 1.77(2.85) kg) and sonography measurements (plantar fascia thickness difference between healthy and affected heel reduction in three weeks: 0.19(0.56) vs. 0.30(0.57) mm). There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)). CONCLUSION No statistically significant difference between groups was observed.",2020,"There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)). ","['Outpatient, University hospital', 'plantar fasciitis', 'Unilateral plantar fasciitis participants ( n \u2009=\u2009102']","['Interventions included eight sessions of laser therapy', 'LLLT', 'high-intensity versus low-level laser therapy', 'HILT and the LLLT', 'high-intensity laser therapy (HILT) and low-level laser therapy (LLLT']","['visual analogue scale (pain in general reduction', 'visual analogue scale; secondary outcomes: pressure algometry, sonography of plantar fascia thickness (time frame: baseline to three-week and four-week follow-up) and numeric rating scale', 'pressure algometry (pain threshold difference between healthy and affected heel reduction']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]",,0.152495,"There was a statistically significant difference between the groups in participants' opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)). ","[{'ForeName': 'Dovile', 'Initials': 'D', 'LastName': 'Naruseviciute', 'Affiliation': 'Department of Rehabilitation, The Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, The Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical rehabilitation,['10.1177/0269215520929073'] 2359,32513043,Assessing school-lunch feeding and nutrition education strategy for healthier kids in selected Philippine public schools.,"BACKGROUND Nutrition interventions during the early years of a child's life are anchored on the need to provide good nutrition and proper health care to optimize their growth potential as adults. In the Philippines, undernutrition is a persistent problem among 0-10 year old Filipino children. In this age group, children consume a diet poor in quantity and quality. AIM This study aimed to assess the effects of a school-lunch and nutrition education intervention among schoolchildren in terms of attaining good nutrition. METHOD Using a quasi-experimental design, children aged 7-9 years from public elementary schools in the province of Laguna, Philippines were categorized into three intervention groups and one non-intervention group. Anthropometric measurements; nutrition knowledge, attitude and behavior; and food intake among children and households were collected at baseline and endline periods. SPSS for Windows version 16 and Stata version 15 were utilized for data analysis. RESULTS Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05). Protein requirement was met by more children and households than the energy requirement. Most children with normal nutritional status after the interventions (25.3%) belonged to the group with the complete intervention of school-lunch and nutrition education. CONCLUSIONS The provision of both school-lunch feeding and nutrition education is effective in improving the knowledge, attitude and behavior scores and nutritional status of schoolchildren. The adoption and institutionalization of complete intervention with school-lunch and nutrition education in elementary public schools should be pursued.",2020,"Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05).","['elementary public schools', 'children aged 7-9 years from public elementary schools in the province of Laguna, Philippines', 'children and households', 'healthier kids in selected Philippine public schools', '0-10 year old Filipino children']","['school-lunch and nutrition education intervention', 'school-lunch and nutrition education']","['Anthropometric measurements; nutrition knowledge, attitude and behavior; and food intake', 'Mean scores on knowledge, attitude and behavior of schoolchildren', 'knowledge, attitude and behavior scores and nutritional status of schoolchildren']","[{'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",,0.0149952,"Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05).","[{'ForeName': 'Julieta B', 'Initials': 'JB', 'LastName': 'Dorado', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Glenda P', 'Initials': 'GP', 'LastName': 'Azaña', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Rowena V', 'Initials': 'RV', 'LastName': 'Viajar', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Ma Anna Rita M', 'Initials': 'MARM', 'LastName': 'Ramirez', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Eldridge B', 'Initials': 'EB', 'LastName': 'Ferrer', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Nesrianne G', 'Initials': 'NG', 'LastName': 'Buyco', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Divorah V', 'Initials': 'DV', 'LastName': 'Aguila', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Mario V', 'Initials': 'MV', 'LastName': 'Capanzana', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}]",Nutrition and health,['10.1177/0260106020930466'] 2360,32517729,Modulation of gut microbiota through nutritional interventions in Behçet's syndrome patients (the MAMBA study): study protocol for a randomized controlled trial.,"BACKGROUND Behçet's syndrome (BS) is a systemic inflammatory disorder of unknown etiology, and it is characterized by a wide range of potential clinical manifestations. Recent evidence suggests that the gut microbiota (GM) in BS has low biodiversity with a significant depletion in butyrate producers. The aim of the present project is to investigate whether a dietary intervention could ameliorate the clinical manifestations and modulate the GM of individuals with BS. METHODS This is a randomized, open, cross-over study that involves 90 individuals with BS, who will be randomly assigned to one of three different diets for 3 months: a lacto-ovo-vegetarian diet (VD), a Mediterranean diet (MD), or a Mediterranean diet supplemented with butyrate (MD-Bt). The VD will contain inulin-resistant and resistant-starch-rich foods, eggs, and dairy in addition to plant-based food, but it will not contain meat, poultry, or fish. The MD will contain all food categories and will provide two portions per week of fish and three portions per week of fresh and processed meat. The MD-Bt will be similar to the MD but supplemented with 1.8 g/day of oral butyrate. The three different diets will be isocaloric and related to the participants' nutritional requirements. Anthropometric measurements, body composition, blood, and fecal samples will be obtained from each participant at the beginning and the end of each intervention phase. The primary outcomes will be represented by the change from baseline of the BS gastrointestinal and systemic symptoms. Changes from baseline in GM composition, short-chain fatty acid (SCFA) production, and the inflammatory and antioxidant profile will be considered as secondary outcomes. DISCUSSION BS is a rare disease, and, actually, not all the available treatments are target therapies. A supportive treatment based on dietary and lifestyle issues, able to restore immune system homeostasis, could have a high impact on cost sustainability for the treatment of such a chronic and disabling inflammatory condition. TRIAL REGISTRATION clinicaltrials.gov: NCT03962335. Registered on 21 May 2019.",2020,"Changes from baseline in GM composition, short-chain fatty acid (SCFA) production, and the inflammatory and antioxidant profile will be considered as secondary outcomes. ","['90 individuals with BS', ""Behçet's syndrome patients"", 'individuals with BS']","['lacto-ovo-vegetarian diet (VD), a Mediterranean diet (MD), or a Mediterranean diet supplemented with butyrate (MD-Bt', 'dietary intervention', 'gut microbiota through nutritional interventions']","['Anthropometric measurements, body composition, blood, and fecal samples', 'BS gastrointestinal and systemic symptoms', 'GM composition, short-chain fatty acid (SCFA) production']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0311165', 'cui_str': 'Lacto-ovo-vegetarian diet'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004943', 'cui_str': ""Behcet's syndrome""}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}]",90.0,0.107448,"Changes from baseline in GM composition, short-chain fatty acid (SCFA) production, and the inflammatory and antioxidant profile will be considered as secondary outcomes. ","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. giuditta.pagliai@gmail.com.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Fiorillo', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, Florence, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Becatti', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, Florence, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Turroni', 'Affiliation': 'Department of Pharmacy and Biotechnology, Unit of Holobiont Microbiome and Microbiome Engineering, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Emmi', 'Affiliation': 'Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}]",Trials,['10.1186/s13063-020-04444-6'] 2361,32517739,"Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection.","BACKGROUND Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections are two commonly used modalities to manage symptoms associated with knee OA. METHODS A prospective 1:1 randomized study was conducted in 177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12 months. HA subjects with unsatisfactory outcomes at 6-months were allowed to crossover and receive CRFA. Knee pain (numeric rating scale = NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect = GPE, EQ-5D-5 L), and adverse events were measured. RESULTS At 12-months, 65.2% of subjects in the CRFA cohort reported ≥50% pain relief from baseline. Mean NRS pain score was 2.8 ± 2.4 at 12 months (baseline 6.9 ± 0.8). Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint. 64.5% of subjects in the crossover cohort reported ≥50% pain relief from baseline, with a mean NRS pain score of 3.0 ± 2.4 at 12 months (baseline 7.0 ± 1.0). After receiving CRFA, subjects in the crossover cohort had a 27.5% improvement in total WOMAC score. All subjects receiving CRFA reported significant improvement in quality of life. There were no serious adverse events related to either procedure and overall adverse event profiles were similar. CONCLUSION A majority of subjects treated with CRFA demonstrated sustained knee pain relief for at least 12-months. Additionally, CRFA provided significant pain relief for HA subjects who crossed over 6 months after treatment. TRIAL REGISTRATION This trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017.",2020,Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint.,"['knee osteoarthritis', '177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12\u2009months', 'HA subjects with unsatisfactory outcomes at 6-months']","['CRFA', 'Cooled radiofrequency ablation', 'cooled radiofrequency ablation', 'Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections', 'hyaluronic acid injection']","['quality of life', 'mean NRS pain score', 'pain relief', 'Knee pain (numeric rating scale\u2009=\u2009NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect\u2009=\u2009GPE, EQ-5D-5\u2009L), and adverse events', 'sustained knee pain relief', 'Mean NRS pain score', 'total WOMAC score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",177.0,0.0637305,Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint.,"[{'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics, Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, USA. afchen@bwh.harvard.edu.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Khalouf', 'Affiliation': 'University Orthopedics Center, 3000 Fairway Dr, Altoona, PA, 16602, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Zora', 'Affiliation': 'University Orthopedics Center, 476 Rolling Ridge Drive, State College, PA, 16801, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, 9020 Stony Point Pkwy #140, Richmond, VA, 23235, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kohan', 'Affiliation': 'University of Virginia School of Medicine, 545 Ray C Hunt Drive, Charlottesville, VA, 22903, USA.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Guirguis', 'Affiliation': 'Ochsner Clinic Foundation, 2820 Napoleon Ave, Ste 210A, New Orleans, LA, 70115, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Beall', 'Affiliation': 'Clinical Investigations, 1800 Renaissance Blvd Suite 110, Edmond, OK, 73013, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loudermilk', 'Affiliation': 'PCPMG Clinical Research Unit LLC, 100 Healthy Way #1260, Anderson, SC, 29621, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pingree', 'Affiliation': 'Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Badiola', 'Affiliation': 'University of Pennsylvania, 3737 Market Street Room 6113, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lyman', 'Affiliation': ""Institute for Orthopedic Research and Innovation, 1110 W Park Place, Suite 212, Coeur d'Alene, ID, 83814, USA.""}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03380-5'] 2362,32517785,Implementing self-management: a mixed methods study of women's experiences of a postpartum hypertension intervention (SNAP-HT).,"BACKGROUND Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management in women with medicated hypertensive disorders of pregnancy. METHODS A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews at 4 weeks and 6 months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of normalisation process theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. RESULTS Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. CONCLUSIONS Interviews and quantitative data showed that self-management enhanced women's sense of control and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible and reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum and reinforce the effectiveness of the intervention used in this study. TRIAL REGISTRATION ClinicalTrials.gov: NCT02333240. Prospectively registered on 7 January 2015.",2020,"In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. ","[""women's experiences of a postpartum hypertension intervention (SNAP-HT"", 'postnatal women with medicated gestational hypertension or pre-eclampsia', 'women with medicated hypertensive disorders of pregnancy']","['usual care or blood pressure self-management', 'postpartum blood pressure self-management', 'Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring']",['blood pressure-related anxiety'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0341934', 'cui_str': 'Transient hypertension of pregnancy'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.101051,"In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. ","[{'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Cairns', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. alexandra.cairns@doctors.org.uk.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Tucker', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Crawford', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-020-04394-z'] 2363,32518039,Progressive rehabilitation of the sprained ankle: A novel treatment method.,"OBJECTIVES This randomised, single blinded cohort study was designed to assess the immediate effect of manual fascial manipulation on walking pain and the range of ankle dorsiflexion within the first 4 days after ankle trauma. METHODS Measurements were taken from 19 subjects, 5 female and 14 male, who presented with grade I-III ankle sprains. Ankle dorsiflexion was photographed in a standardised position and calculated by means of the Dartfish® Advanced Video Analysis Software and SPSS® (version 17) was used to compare the pre- and post-treatment data. RESULTS After one treatment session 13 of the 19 subjects were walking pain free and 3 of the 19 where walking with only little pain. The highly significant (p<0.001) mean improvement of ankle dorsiflexion was 7.9° (±5.8°). All, apart from one subject, whom were walking pain free after treatment showed a minimum of 4° increased dorsiflexion. CONCLUSION Early fascia work around the injured ankle improves ankle dorsiflexion and reduces walking pain. It may reduce the delay of tissue healing and, thus, optimise further rehabilitation of the sprained ankle which may also reduce socio-economic costs.",2020,The highly significant (p<0.001) mean improvement of ankle dorsiflexion was 7.9° (±5.8°).,"['Measurements were taken from 19 subjects, 5 female and 14 male, who presented with grade I-III ankle sprains', 'Progressive rehabilitation of the sprained ankle']",['manual fascial manipulation'],"['walking pain and the range of ankle dorsiflexion', 'ankle dorsiflexion and reduces walking pain', 'walking pain free', 'ankle dorsiflexion', 'Ankle dorsiflexion']","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",19.0,0.0611123,The highly significant (p<0.001) mean improvement of ankle dorsiflexion was 7.9° (±5.8°).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maetzler', 'Affiliation': 'Praxisgemeinschaft Reha Med, Hof 368b, 6866 Andelsbuch, Austria; Institute of Motion Analysis and Research (IMAR), Department of Orthopaedics & Trauma Surgery, TORT Centre, Ninewells Hospital & Medical School, Dundee DD1 9SY, Scotland, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruescher', 'Affiliation': 'Praxisgemeinschaft Reha Med, Hof 368b, 6866 Andelsbuch, Austria.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Punzenberger', 'Affiliation': 'Praxisgemeinschaft Reha Med, Hof 368b, 6866 Andelsbuch, Austria.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Institute of Motion Analysis and Research (IMAR), Department of Orthopaedics & Trauma Surgery, TORT Centre, Ninewells Hospital & Medical School, Dundee DD1 9SY, Scotland, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Abboud', 'Affiliation': 'Faculty of Engineering, University of Balamand, Koura, Lebanon. Electronic address: rjabboud@balamand.edu.lb.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2019.09.007'] 2364,32518042,Population Pharmacokinetics Analysis of Quetiapine Extended-release Formulation in Japanese Patients with Bipolar Depression.,"PURPOSE The objectives of this study were to explore covariates of plasma quetiapine concentrations after oral administration of quetiapine extended-release formulation (XR), and to examine the exposure-response relationship in Japanese patients with bipolar depression, using population pharmacokinetics (PopPK) modeling. METHODS In a multicenter, randomized, double-blind, placebo-controlled study of quetiapine XR in patients with bipolar depression, plasma for the measurement of quetiapine concentration was collected at weeks 2, 4, 8, 12, 20, 28, and 52 during oral administration of 150 or 300 mg once daily of quetiapine XR before bedtime. A PopPK model of quetiapine XR was developed using nonlinear mixed-effects modeling with first-order conditional estimation with interactions. The exposure-response relationship was examined using post-hoc exposures. The post-hoc AUC estimate was plotted against the change in the Montgomery-Åsberg Depression Rating Scale (ΔMADRS) total score from baseline to 8 weeks following once-daily doses at 300 mg. FINDINGS The final PopPK analysis dataset contained 322 patients and 1162 observations (cutoff data at week 28; cutoff date, February 2016). The plasma quetiapine concentration-time profile in patients with bipolar depression after oral administration of quetiapine XR was represented well using a 1-compartment with first-order absorption model. Covariate analysis led to the selection of γ-glutamyl transpeptidase on apparent oral clearance and body weight on apparent volume of distribution as covariates. The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. IMPLICATIONS The effects of covariates on PK parameters were not large compared with the interindividual variability. In addition, there was no clear relationship between the AUC and ΔMADRS. ClinicalTrials.gov identifier: NCT01725308.",2020,"The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. ","['patients with bipolar depression, plasma for the measurement of quetiapine concentration was collected at weeks 2, 4, 8, 12, 20, 28, and 52 during oral administration of 150 or 300\xa0mg once daily of', 'Japanese Patients with Bipolar Depression', 'Japanese patients with bipolar depression, using population pharmacokinetics (PopPK) modeling', 'patients with bipolar depression after oral administration of']","['quetiapine extended-release formulation (XR', 'quetiapine XR', 'Quetiapine', 'placebo']","['oral clearance and apparent volume of distribution', 'plasma quetiapine concentrations', 'Montgomery-Åsberg Depression Rating Scale (ΔMADRS) total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1997945', 'cui_str': 'Measurement of quetiapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1135768', 'cui_str': 'Extended Release Formulations'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0397568,"The final population mean values of apparent oral clearance and apparent volume of distribution were 87.7 L/h and 277 L, respectively, and the interindividual %CVs were 32.6% and 75.0%, respectively. ","[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Fukushi', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. Electronic address: risa.fukushi@astellas.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Kanji', 'Initials': 'K', 'LastName': 'Komatsu', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}, {'ForeName': 'Akitsugu', 'Initials': 'A', 'LastName': 'Takada', 'Affiliation': 'Astellas Pharma Global Development Inc, Northbrook, IL, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.006'] 2365,32518060,A protocol for a pilot randomized controlled trial of guided self-help Behavioral Activation intervention for geriatric depression.,"BACKGROUND Aging is a social concern. The increased incidence of depression in Chinese older populations poses a challenge to our health care system. Depressed older adults often suffer from lack of motivation. Evidence-based guided self-help behavioral activation (BA) treatment is effective in reducing anhedonia and amotivation symptoms, however the efficacy of guided self-help BA in elderly depressed patients are unknown yet. OBJECTIVE So the current study aim to pilot the self-help guided intervention for the treatment of depression in elderly patients. METHODS A pilot randomized controlled trial with 30 elderly inpatients with major depressive disorder will be conducted. Participants attending clinical psychological clinics at Mental Health Center of Chongqing will be randomized to receive guided self-help BA intervention or to a 6-week waiting list control. Participants in the treatment group will receive 6 sessions of guided self-help BA intervention delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 6 weeks. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than depression or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Chinese Research Ethics Committee. Our hypothesis is that guided self-help BA will effective when compared with the waiting-list intervention. RESULTS Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use). We also examine mediators of outcomes in terms of patient variables (behavioral activation/inhibition motivation). Results will be disseminated to patients, the wider public, clinicians and researchers through publication in journals and presentation at conferences. CONCLUSIONS This is the first study to investigate guided self-help interventions for China geriatric depressed patients, a group which is currently under-represented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression (BATD). The generalizability and broad inclusion criteria are strengths but may also lead to some weaknesses. CLINICALTRIAL ChiCTR1900026066.",2020,"RESULTS Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","['geriatric depression', 'Chinese older populations', 'elderly depressed patients', 'China geriatric depressed patients, a group which is currently under-represented in mental health research', 'Participants attending clinical psychological clinics at Mental Health Center of Chongqing', 'elderly patients', '30 elderly inpatients with major depressive disorder', 'Depressed older adults']","['Evidence-based guided self-help behavioral activation (BA) treatment', 'guided self-help interventions', 'guided self-help BA intervention or to a 6-week waiting list control', '6 sessions of guided self-help BA intervention delivered over the telephone', 'guided self-help Behavioral Activation intervention']","['three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",30.0,0.053098,"RESULTS Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Army Medical University, 30 # Gaotanyan Main Street, Shapingba District, Chongqing, CN.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center of Chongqing, Chongqing, CN.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Mental Health Center of Chongqing, Chongqing, CN.'}]",JMIR research protocols,['10.2196/18259'] 2366,32518063,Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial.,"INTRODUCTION The present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS In this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates. RESULTS Forty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: -0.46% (-5.0 mmol/mol), p<0.001; SMBG: -0.17% (-1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference -0.29% (-3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group. CONCLUSIONS Glycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes. TRIAL REGISTRATION NUMBER UMIN000026452, jRCTs041180082.",2020,"The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks.","['patients with non-insulin-treated type 2 diabetes', 'non-insulin-treated type 2 diabetes', 'Forty-eight participants in the FGM group and 45 in the SMBG group completed the study', 'patients with non-insulin-treated type 2 diabetes at five hospitals in Japan']","['FGM', 'Flash glucose monitoring', 'SMBG', 'flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG', 'conventional self-monitoring of blood glucose']","['glycated hemoglobin (HbA1c) level', 'Diabetes Treatment Satisfaction Questionnaire score', 'mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia', 'FGM', 'mean HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0597915,"The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (-0.43% (-4.7 mmol/mol), p<0.001) and SMBG groups (-0.30% (-3.3 mmol/mol), p=0.001) at 12 weeks.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Wada', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan t-onoue@med.nagoya-u.ac.jp arima105@med.nagoya-u.ac.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Handa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Hayase', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Furukawa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okuji', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Iwama', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Tsunekawa', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Hagiwara', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Suga', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Banno', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yachiyo', 'Initials': 'Y', 'LastName': 'Kuwatsuka', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Motomitsu', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan t-onoue@med.nagoya-u.ac.jp arima105@med.nagoya-u.ac.jp.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001115'] 2367,32518064,GIP and GLP-1 Potentiate Sulfonylurea-Induced Insulin Secretion in Hepatocyte Nuclear Factor 1-Alpha Mutation Carriers.,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia. Treatment based on the incretin hormones, glucose-dependent insulinotropic peptide (GIP) and glucagon-like-peptide 1 (GLP-1), are characterized by their glucose-dependent insulinotropic actions without risk of hypoglycemia. The effect of SUs together with GIP or GLP-1, respectively, on insulin and glucagon secretion in patients with HNF1A-diabetes is currently unknown. To investigate this, ten HNF1A mutation carriers and ten non-diabetic controls were recruited for a double-blinded, placebo-controlled, crossover study including six experimental days in a randomized order involving 2h euglycemic-hyperglycemic clamps with co-administration of 1) SU (glimepiride 1 mg) or placebo, combined with 2) infusions of either GIP (1.5 pmol/kg/min), GLP-1 (0.5 pmol/kg/min) or saline (NaCl). In HNF1A mutation carriers we observed: 1) hypoinsulinemia, 2) insulinotropic effects of both GIP and GLP-1, 3) additive to supra-additive effects on insulin secretion when combining SU+GIP and SU+GLP1, respectively, and 4) increased fasting and arginine-induced glucagon levels compared to non-diabetic controls. Our study suggests that a combination of SU and incretin-based treatment may be efficacious in patients with HNF1A-diabetes via potentiation of glucose-stimulated insulin secretion.",2020,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","['patients with HNF1A-diabetes', 'patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes', 'ten HNF1A mutation carriers and ten non-diabetic controls']","['GIP and GLP-1', 'euglycemic-hyperglycemic clamps with co-administration of 1) SU (glimepiride 1 mg) or placebo, combined with 2) infusions of either GIP', 'GLP-1 (0.5 pmol/kg/min) or saline (NaCl', 'Sulfonylureas (SUs', 'placebo']","['fasting and arginine-induced glucagon levels', 'insulin and glucagon secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0209278', 'cui_str': 'Liver-Specific Transcription Factor LF-B1'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0986239', 'cui_str': 'glimepiride 1 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0574518', 'cui_str': 'Susu language'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.0900443,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0074'] 2368,32518098,Phosphorylated Acetyl-CoA Carboxylase is associated with clinical benefit with Regorafenib in relapsed glioblastoma: REGOMA Trial Biomarker Analysis.,"PURPOSE Pre-clinical studies show that anti-angiogenic therapy exacerbates tumor glycolysis and activates liver kinase B1 (LKB1)/AMP kinase (AMPK), a pathway involved in regulation of tumor metabolism. We investigated whether certain metabolism-related in situ biomarkers could predict benefit to regorafenib in the phase 2 randomized REGOMA trial. EXPERIMENTAL DESIGN Immunohistochemistry and digital pathology analysis were used to investigate expression in GBM sections of monocarboxylate transporter 1 and 4 (MCT1, MCT4), associated with OXPHOS and glycolysis, respectively, phosphorylated AMPK (pAMPK) and phosphorylated acetyl-CoA carboxylase (pACC), a canonical target of AMPK activity. The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression free survival (PFS) in patients (PTS) with relapsed GBM treated either with regorafenib or lomustine. RESULTS Between November 2015 and February 2017, 119 PTS were enrolled (n=59 regorafenib; n=60 lomustine) and stratified for surgery at recurrence; baseline characteristics were balanced. Biomarker analysis was performed in 84 PTS (71%), including 42 PTS of the regorafenib arm and 42 PTS of the lomustine arm. Among all markers analyzed, only pACC showed predictive value in terms of OS. In fact, median OS was 9.3 months (m) (95% CI 5.6-13.2) for regorafenib and 5.5m (95% CI 4.2-6.6) for lomustine for pACC positive patients, HR 0.37 (95% CI 0.20-0.70), log rank p-value = 0.0013; Test for interaction = 0.0453. No statistically significant difference was demonstrated about PFS according to pACC status. CONCLUSIONS We found that AMPK pathway activation is associated with clinical benefit from treatment with regorafenib in relapsed GBM.",2020,"The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression free survival (PFS) in patients (PTS) with relapsed GBM treated either with regorafenib or lomustine. ","['patients (PTS) with relapsed GBM treated either with', '119 PTS were enrolled (n=59 regorafenib; n=60 lomustine) and stratified for surgery at recurrence; baseline characteristics were balanced', 'Between November 2015 and February 2017']","['Phosphorylated Acetyl-CoA Carboxylase', 'regorafenib or lomustine', 'lomustine']","['median OS', 'overall survival (OS) and progression free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0001022', 'cui_str': 'Acetyl-CoA carboxylase'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.150143,"The status of each biomarker was associated with clinical endpoints, including overall survival (OS) and progression free survival (PFS) in patients (PTS) with relapsed GBM treated either with regorafenib or lomustine. ","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Indraccolo', 'Affiliation': 'Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV-IRCCS stefano.indraccolo@unipd.it.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IRCCS.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Verza', 'Affiliation': 'Immunology Molecular Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Caccese', 'Affiliation': 'Department of Oncology Oncology 1, Veneto Institute of Oncology IOV-IRCSS.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Piga', 'Affiliation': 'Istituto Oncologico Veneto IOV - IRCCS.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Del Bianco', 'Affiliation': 'Clinical Research Unit, Istituto Oncologico Veneto IOV - IRCCS.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pizzi', 'Affiliation': 'University of Padua.'}, {'ForeName': 'Marina Paola', 'Initials': 'MP', 'LastName': 'Gardiman', 'Affiliation': 'Surgical Pathology & Cytopathology Unit, University Hospital, Padova.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Molecular Neuro-Oncology Unit, Fondazione IRCCS Istituto Neurologico Besta.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rudà', 'Affiliation': 'Department of Neuro-Oncology, City of Health and Science and University of Turin, Italys.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology, AUSL/IRCCS Institute of Neurological Sciences.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology & Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rizzato', 'Affiliation': 'Department of Oncology, Azienda Sanitaria-Universitaria Integrata.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lolli', 'Affiliation': 'Department of Oncology, IRCSS Saverio de Bellis.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'U.O.C. Oncologia Medica 1, Istituto Oncologico Veneto, IRCCS.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lombardi', 'Affiliation': 'Department of Oncology, Istituto Oncologico Veneto.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4055'] 2369,32518394,Effect of brimonidine tartrate 0.15% on scotopic pupil size and upper eyelid position: controlled trial.,"BACKGROUND To evaluate the effect of brimonidine tartrate 0.15% ophthalmic solution on pupil size under scotopic condition and upper eyelid position. METHODS This study comprised 72 eyes of 36 healthy subjects. A single drop of brimonidine tartrate 0.15% ophthalmic solution was instilled in the right eye and artificial tear was instilled in the left eye. Pupil size was measured using an infra-red pupillometer under scotopic condition before and at 30 min, 2, 4, 6, 8 and 10 h after instillation. Measurement of margin reflex distance 1 (MRD1) was performed using a millimetre ruler before and after at 10 min after instillation. RESULTS The mean age of the subjects was 32.19 ± 11.43 years (range 10-52 years), 17 were female and 19 were male. Before brimonidine instillation, the mean pupil size was 6.09 ± 1.03 mm in the brimonidine eyes and 6.06 ± 1.04 mm in the control eyes. There was a significant decrease in mean pupil size at 30 min (4.45 ± 1.04), 2 h (4.49 ± 1.06), 4 h (4.59 ± 1.06), 6 h (4.89 ± 1.06) and 8 h (5.38 ± 1.02) after instillation compared to before in brimonidine eyes (p < 0.001 for all). There was a significant miosis continued for at least 6 h (5.95 ± 1.03) in control eyes (p < 0.001). There was no significant change in MRD1, before and after instillation both in brimonidine and control eyes. CONCLUSIONS Brimonidine tartrate 0.15% had a significant miosis under scotopic condition for at least 8 h after instillation and had a significant miosis on the untreated eye for at least 6 h.",2020,"There was no significant change in MRD1, before and after instillation both in brimonidine and control eyes. ","['72 eyes of 36 healthy subjects', 'The mean age of the subjects was 32.19\u2009±\u200911.43 years (range 10-52 years), 17 were female and 19 were male', 'pupil size under scotopic condition and upper eyelid position']","['brimonidine tartrate 0.15% ophthalmic solution', 'brimonidine tartrate', 'brimonidine', 'Brimonidine tartrate']","['mean pupil size', 'scotopic pupil size and upper eyelid position', 'Pupil size', 'Measurement of margin reflex distance 1 (MRD1', 'MRD1', 'significant miosis', 'miosis under scotopic condition']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C1164784', 'cui_str': 'Brimonidine tartrate 1.5 mg/mL eye solution'}, {'cui': 'C0077768', 'cui_str': 'Brimonidine tartrate'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1827217', 'cui_str': 'Margin reflex distance'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",36.0,0.0623986,"There was no significant change in MRD1, before and after instillation both in brimonidine and control eyes. ","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Tuncer', 'Affiliation': 'Alfa Medical Center, Izmir, Turkey. ibrahimtuncer106@gmail.com.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Medifema Hospital, Izmir, Turkey.'}, {'ForeName': 'Mehmet Özgür', 'Initials': 'MÖ', 'LastName': 'Zengin', 'Affiliation': 'Izmir Katip Celebi University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Mehmet Serhat', 'Initials': 'MS', 'LastName': 'Mangan', 'Affiliation': 'Haydarpasa Numune Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'Alfa Medical Center, Izmir, Turkey.'}, {'ForeName': 'Cezmi', 'Initials': 'C', 'LastName': 'Doğan', 'Affiliation': 'Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Esat', 'Initials': 'E', 'LastName': 'Çınar', 'Affiliation': 'Ekol Hospital, Izmir, Turkey.'}]","Eye (London, England)",['10.1038/s41433-020-1007-9'] 2370,32519235,The long-term consequence of salivary contamination at various stages of adhesive application and clinically feasible remedies to decontaminate.,"OBJECTIVE To analyse the bond quality in dentine post-ageing after salivary contamination and decontamination at different stages of dental adhesive application. MATERIALS AND METHODS A total of 1120 human dentine specimens were randomly allocated to 14 groups for four intervals (n = 20) to be treated with a self-etching (SE) and universal (U) adhesive. The saliva contamination and decontamination were implemented after surface preparation, after primer application (for SE) and after adhesive curing. The decontamination groups were either rinsed and air-dried or rinsed, air-dried and reapplied with adhesive. They were stored (37 °C, distilled water) for four intervals (1 week, 1 month, 3 months and 1 year) and subjected to shear bond strength (SBS) test at a crosshead speed of 0.5 mm/min. RESULT One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application. However, decontamination improved the SBS in SE but not in U adhesive. The univariate analysis confirmed significant influences (p < 0.0001) seen by treatment procedure ([Formula: see text]=0.075), type of adhesive ([Formula: see text] = 0.328), ageing ([Formula: see text] = 0.13), experimental groups ([Formula: see text] = 0.518), and the stage of influence ([Formula: see text] = 0.60). CONCLUSION Saliva contamination is detrimental after primer application in SE but, decontamination regained the SBS and maintained it over time. In U adhesive, SBS deteriorated over time irrespective of the contamination. CLINICAL RELEVANCE Salivary contamination showed different influences on SBS at various stages of restoration with contemporary dental adhesives.",2020,One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application.,['1120 human dentine specimens'],"['self-etching (SE) and universal (U) adhesive', 'rinsed and air-dried or rinsed, air-dried and reapplied with adhesive']",['SBS'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",1120.0,0.024381,One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application.,"[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, Goethestraße 70, 80336, Munich, Germany. poojanair8888@gmail.com.'}, {'ForeName': 'Nicoleta', 'Initials': 'N', 'LastName': 'Ilie', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, Goethestraße 70, 80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03307-3'] 2371,32519236,Analysis of the smear layer generated by different activation systems: an in vitro study.,"OBJECTIVES To evaluate via scanning electron microscopy the amount of smear layer generated during the use of sonic and ultrasonic activation systems with standardized short-term intentional contacts with the canal walls. METHODOLOGY Seventy single-root human teeth were randomly assigned to 2 control (n = 5 each): NC (negative control), PC (positive control) and four experimental groups (n = 15 each): NC (negative control), PC (positive control), G1 (passive ultrasonic irrigation with Irrisafe), G2 (ultrasonic irrigation with EndoUltra), G3 (sonic irrigation with Endoactivator), G4 (sonic irrigation with Eddy). Samples were instrumented with ProTaper Next®. An irrigation protocol with sodium hypochlorite (NaOCl) and ethylenediaminetetraacetic acid (EDTA) was followed for both PC and the experimental groups. Standardized intentional contacts were made in the mesial walls during 5 s at WL - 2 mm in all experimental groups. Two calibrated evaluators scored the smear layer generated with an ordinal scale by scanning electron microscopy. The weighted kappa coefficient (K w ) was calculated to determine the inter-observer agreement. Post-consensus ordinal data were analyzed using the ordinal (linear) chi-square test. RESULTS When the agitation file is in contact with dentine walls, Irrisafe® significantly generated the least amount of smear layer in the coronal third (p < 0.05). Both in the middle and apical third, activation with Irrisafe® also showed statistically significant better results than Eddy™ and EndoUltra®. Endoactivator® showed significant better results than EndoUltra® and Eddy™ in the apical third (p < 0.05). CONCLUSIONS Irrisafe generated the least amount of smear layer in the entire canal and similar to Endoactivator in the apical third when the agitation file is in contact with dentine walls. CLINICAL RELEVANCE The smear layer is generated during activation. It is common to apply irrigation protocols where after the removal of the smear layer using chelants, a final rinse and activation is carried out but there are no previous studies analyzing the possible creation of a new smear layer with this final activation.",2020,"Endoactivator® showed significant better results than EndoUltra® and Eddy™ in the apical third (p < 0.05). ",['Seventy single-root human teeth'],"['NC (negative control), PC (positive control), G1 (passive ultrasonic irrigation with Irrisafe), G2 (ultrasonic irrigation with EndoUltra), G3 (sonic irrigation with Endoactivator), G4 (sonic irrigation with Eddy', 'sodium hypochlorite (NaOCl) and ethylenediaminetetraacetic acid (EDTA']",['weighted kappa coefficient (K w '],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",,0.0217025,"Endoactivator® showed significant better results than EndoUltra® and Eddy™ in the apical third (p < 0.05). ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rius', 'Affiliation': 'School of Dentistry, Universidad Rey Juan Carlos (URJC), Av. Atenas, S/N, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arias', 'Affiliation': 'School of Dentistry, Universidad Complutense (UCM), Madrid, Spain.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Aranguren', 'Affiliation': 'School of Dentistry, Universidad Rey Juan Carlos (URJC), Av. Atenas, S/N, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Romero', 'Affiliation': 'School of Dentistry, Universidad Rey Juan Carlos (URJC), Av. Atenas, S/N, 28922, Alcorcón, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'de Gregorio', 'Affiliation': 'School of Dentistry, Universidad Rey Juan Carlos (URJC), Av. Atenas, S/N, 28922, Alcorcón, Madrid, Spain. cesargre@icloud.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03355-9'] 2372,32519238,A comparative study of initial changes in pulpal blood flow between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.,"OBJECTIVES To evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016 × 0.022 NiTi as alignment archwire. MATERIALS AND METHODS Twenty-two patients (16 females and 6 males) aged 19.00 ± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. The intervention (self-ligating brackets) was randomly allocated to the right or left side of the patient using the permuted random block size of 2 with 1:1 allocation ratio. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients. Two alignment archwires; 0.016″ NiTi and 0.016 × 0.022″ NiTi were used in this study. PBF was measured for the lower right and left sides using laser Doppler flowmetry at different time intervals (20 min, 24 h, 72 h, 1 week, and 1 month) RESULTS: PBF started to decrease 20 min after insertion of both archwires using both types of brackets. Maximum decrease was reached after 72 h of archwire insertion. After 1 week of force application, PBF started to increase to restore its original values after 1 month. Differences between the 2 groups were not significant (P > 0.05). CONCLUSIONS In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month. Changes in PBF at the measured time intervals in the two groups were similar. CLINICAL RELEVANCE The use of 0.016 × 0.022″ NiTi immediately after 0.016″ NiTi for alignment does not produce any damaging effect on the teeth.",2020,"In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month.",['Twenty-two patients (16 females and 6 males) aged 19.00 ± 2.53 years who presented with mild lower arch crowding were selected to participate in the study'],['conventional and self-ligating fixed orthodontic brackets'],"['pulpal blood flow', 'pulpal blood flow (PBF', 'PBF']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.026219,"In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month.","[{'ForeName': 'Elham S', 'Initials': 'ES', 'LastName': 'Abu Alhaija', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan.'}, {'ForeName': 'Nessrin A', 'Initials': 'NA', 'LastName': 'Taha', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan. n.taha@just.edu.jo.'}]",Clinical oral investigations,['10.1007/s00784-020-03386-2'] 2373,32519327,The Effect of Video-Assisted Education Prior Intrathecal Chemotherapy on Anxiety and Knowledge Enhancement.,"Intrathecal chemotherapy procedures are stressful to patients and caregivers, especially the first time. Providing the patient and caregiver with sufficient information to address their concerns before the scheduled procedure is necessary. This study aims to determine whether the use of video instructions could enhance learning outcomes and decrease anxiety levels in patients' caregivers. A prospective trial was conducted in pediatric hematology for 1 year. Thirty-seven respondents were randomly assigned to two groups wherein one group was given conventional educational leaflets and verbal instructions, while the other group received the same information through an educational video presentation before the intrathecal chemotherapy procedure. Knowledge enhancement in the two groups was evaluated using the summative assessment method and measured by a 10-point Likert scale. The validated Arabic version of the Beck Anxiety Inventory (BAI) scale was used to assess anxiety levels. The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91). Similarly, the overall Beck scale score revealed that palpitation, frightening, lightheadedness, and hot/cold sweat levels were decreased in the video presentation group. Additionally, a significant difference in knowledge enhancement was noted between the two groups, as knowledge enhancement in the video presentation group (7.61 ± 1.88) was better than that in the conventional group (6.00 ± 1.00). This produced a domino effect on the anxiety level scores of both groups. An educational video presentation before the intrathecal chemotherapy procedure is effective since both visual and auditory senses are involved. This could be considered a good source of an interventional approach before a therapeutic procedure.",2020,The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91).,"['Thirty-seven respondents', 'pediatric hematology for 1\xa0year', ""patients' caregivers""]","['Intrathecal chemotherapy procedures', 'conventional educational leaflets and verbal instructions, while the other group received the same information through an educational video presentation before the intrathecal chemotherapy procedure', 'Video-Assisted Education Prior Intrathecal Chemotherapy', 'video instructions']","['anxiety level scores', 'validated Arabic version of the Beck Anxiety Inventory (BAI) scale', 'anxiety level', 'overall Beck scale score revealed that palpitation, frightening, lightheadedness, and hot/cold sweat levels', 'knowledge enhancement', 'Anxiety and Knowledge Enhancement', 'anxiety levels', 'learning outcomes']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C1690538', 'cui_str': 'Pediatric hematology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C3665472', 'cui_str': 'Chemotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0232431', 'cui_str': 'Cold sweat'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",37.0,0.0290394,The anxiety level (12.31 ± 8.84) in the video presentation group was significantly higher than that in the conventional group (6.16 ± 5.91).,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Bany Hamdan', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia. ahamdan@kfmc.med.sa.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Ballourah', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Assem', 'Initials': 'A', 'LastName': 'Elghazaly', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sherwynn', 'Initials': 'S', 'LastName': 'Javison', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Alshammary', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Erlandez', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Garatli', 'Affiliation': 'National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Mohammed', 'Affiliation': 'National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Alharbi', 'Affiliation': 'Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01787-1'] 2374,32519368,Effect of cyclopentolate versus tropicamide on anterior segment angle parameters in three refractive groups.,"CLINICAL RELEVANCE Frequent clinical application of cycloplegia in clinical practice makes it essential to assess how this condition influences anterior segment angle parameters. BACKGROUND This study aims to compare the effects of cyclopentolate and tropicamide on anterior segment angle parameters in three adult refractive groups. METHODS Sixty healthy individuals were recruited and assigned into three refractive groups according to inclusion criteria. At baseline visit, anterior segment angle parameters were measured using anterior segment optical coherence tomography in the right eye. All measurements were repeated at two separate visits, one week apart, after administration of tropicamide 1% and cyclopentolate 1% at similar conditions. Main outcome measures were angle-opening distance, trabecular iris angle, trabecular iris space area and anterior chamber depth. Anterior segment angle parameters were recorded at temporal areas (180 degrees). RESULTS Sixty participants (29 men and 31 women, age: 27.82 ± 4.71 years) completed the experiment. Baseline mean spherical equivalents were +1.52 ± 1.20 D, -0.04 ± 0.33 D and -1.91 ± 0.91 D in hyperopic, emmetropic and myopic groups, respectively. No statistically significant differences were found between tropicamide and cyclopentolate for all angle parameters in three refractive groups. Both drops induced an increase in all parameters in three refractive groups. Analysis between refractive groups revealed that a more hyperopic refraction was associated with less trabecular iris angle, angle-opening distance and anterior chamber depth parameters in baseline, after tropicamide and cyclopentolate instillations. CONCLUSIONS Topical application of cycloplegic eye drops in healthy individuals leads to small but significant changes in anterior chamber depth and anterior segment angle parameters, regardless of refractive status. Moreover, lower values of anterior chamber depth and anterior segment angle parameters in hyperopic individuals after administration of cycloplegic drops should be taken into account during biometric measurement and phakic intraocular lens implantation. Due to shorter effect and recovery time and less ocular/systemic reaction of tropicamide versus cyclopentolate, tropicamide could be a recommended cycloplegic agent for diagnostic and therapeutic procedures.",2020,No statistically significant differences were found between tropicamide and cyclopentolate for all angle parameters in three refractive groups.,"['three adult refractive groups', 'Sixty healthy individuals', 'Sixty participants (29 men and 31 women, age: 27.82\u2009±\u20094.71\u2009years) completed the experiment', 'healthy individuals']","['cyclopentolate', 'cyclopentolate and tropicamide', 'cyclopentolate, tropicamide', 'tropicamide and cyclopentolate', 'tropicamide', 'tropicamide 1% and cyclopentolate']","['anterior chamber depth and anterior segment angle parameters', 'trabecular iris angle, angle-opening distance and anterior chamber depth parameters', 'angle-opening distance, trabecular iris angle, trabecular iris space area and anterior chamber depth', 'anterior segment angle parameters', 'hyperopic refraction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}]","[{'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",3.0,0.034341,No statistically significant differences were found between tropicamide and cyclopentolate for all angle parameters in three refractive groups.,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Moghadas Sharif', 'Affiliation': 'Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Shoeibi', 'Affiliation': 'Eye Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Heydari', 'Affiliation': 'Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Negareh', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': 'Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ghasemi-Moghaddam', 'Affiliation': 'Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Asieh', 'Initials': 'A', 'LastName': 'Ehsaei', 'Affiliation': 'Department of Optometry, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Clinical & experimental optometry,['10.1111/cxo.13103'] 2375,32519585,Treatments and outcomes of encapsulating peritoneal sclerosis in patients undergoing peritoneal dialysis: 295 cases from a nationwide inpatient database in Japan.,"BACKGROUND The number of patients undergoing renal replacement therapy is increasing. We evaluated the practice patterns and outcomes of encapsulating peritoneal sclerosis (EPS) in patients undergoing peritoneal dialysis. METHODS Using a Japanese national inpatient database, we identified 295 patients with EPS who were hospitalized from July 2010 to March 2017. We categorized them into four groups: those who underwent surgery only ( n = 39), those who received corticosteroid treatment only ( n = 70), those who underwent both ( n = 30), and those who underwent neither ( n = 156). We investigated their characteristics, treatments, and outcomes. RESULTS More than half of patients were males and never-smokers and had a normal body mass index. Patients tended to undergo parenteral nutrition for 2 months. The proportions of emergency admission, intensive care unit (ICU) admission, central venous catheterization, catecholamine use, mechanical ventilation, and continuous hemodiafiltration were significantly different among the four groups (61%, 8.1%, 37.0%, 44.0%, 8.8%, and 5.8%, respectively). The both-treatment group had a significantly longer hospital stay (37.0 vs. 37.5 vs. 72.5 vs. 31.0 days, p < 0.001) and higher costs (US$16,554 vs. US$17,029 vs. US$33,757 vs. US$13,983, p < 0.001) than the other groups. In total, 52 patients (18%) died during hospitalization. There was no significant difference in inhospital complications and death, discharge status, 30-day readmission, or length of ICU stay among the four groups. CONCLUSIONS Our findings provide useful information for clinicians and patients hospitalized for treatment of EPS.",2020,"There was no significant difference in inhospital complications and death, discharge status, 30-day readmission, or length of ICU stay among the four groups. ","['patients undergoing', 'patients undergoing peritoneal dialysis', 'patients undergoing peritoneal dialysis: 295 cases from a nationwide inpatient database in Japan', '295 patients with EPS who were hospitalized from July 2010 to March 2017']","['renal replacement therapy', 'corticosteroid treatment']","['longer hospital stay', 'inhospital complications and death, discharge status, 30-day readmission, or length of ICU stay', 'proportions of emergency admission, intensive care unit (ICU) admission, central venous catheterization, catecholamine use, mechanical ventilation, and continuous hemodiafiltration', 'higher costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2717860', 'cui_str': 'Encapsulating peritoneal sclerosis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0586514', 'cui_str': 'Discharge status'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0472686', 'cui_str': 'Continuous hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",52.0,0.0322671,"There was no significant difference in inhospital complications and death, discharge status, 30-day readmission, or length of ICU stay among the four groups. ","[{'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Konishi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Michimasa', 'Initials': 'M', 'LastName': 'Fujiogi', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Michihata', 'Affiliation': 'Department of Health Services Research, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Morita', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Matsui', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fushimi', 'Affiliation': 'Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Tanabe', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Seto', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Yasunaga', 'Affiliation': 'Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Japan.'}]",Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.1177/0896860820930635'] 2376,32519588,Does mental fatigue impair physical performance? A replication study.,"Objective : to replicate the hypothesis that mental fatigue impairs physical performance. Design : a pre-registered (https://osf.io/wqkap/), randomized, within-subject experiment. Methods : 30 recreationally active adults completed a time-to-exhaustion test (TTE) at 80% VO 2 max in two separate sessions, after completing a mental fatigue task or watching a documentary for 90 min. We measured power output, heart rate, (session) RPE and subjective mental fatigue state. Results : Bayes factor analyses revealed extreme evidence supporting the alternative hypothesis that the mental fatigue task was more mentally fatiguing than the control task, BF 01 = 0.009. However, we found moderate-to-strong evidence for the null hypothesis (i.e., no evidence of reduced performance) for average time in TTE (BF 01 = 9.762) and anecdotal evidence for the null hypothesis in (session) RPE (BF 01 = 2.902) and heart rate (BF 01 = 2.587). Conclusions : our data seem to challenge the idea that mental fatigue has a negative influence on exercise performance. Although we did succeed at manipulating subjective mental fatigue, this did not impair physical performance. However, we cannot discard the possibility that mental fatigue may have a negative influence under conditions not explored here, e.g., individualizing mentally fatiguing tasks. In sum, further research is warranted to determine the role of mental fatigue on exercise and sport performance.",2020,"Bayes factor analyses revealed extreme evidence supporting the alternative hypothesis that the mental fatigue task was more mentally fatiguing than the control task, BF 01 = 0.009.",[],['mental fatigue task or watching a documentary for 90 min'],"['subjective mental fatigue', 'power output, heart rate, (session) RPE and subjective mental fatigue state', 'mental fatigue task', 'heart rate', 'time-to-exhaustion test (TTE']",[],"[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}]",,0.0379538,"Bayes factor analyses revealed extreme evidence supporting the alternative hypothesis that the mental fatigue task was more mentally fatiguing than the control task, BF 01 = 0.009.","[{'ForeName': 'Darías', 'Initials': 'D', 'LastName': 'Holgado', 'Affiliation': 'Centro de Investigación, Mente, Cerebro y Comportamiento. Departamento de Psicología Experimental, Universidad de Granada, España.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Troya', 'Affiliation': 'Centro de Investigación, Mente, Cerebro y Comportamiento. Departamento de Psicología Experimental, Universidad de Granada, España.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Perales', 'Affiliation': 'Centro de Investigación, Mente, Cerebro y Comportamiento. Departamento de Psicología Experimental, Universidad de Granada, España.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Vadillo', 'Affiliation': 'Departamento de Psicología Básica, Universidad Autónoma de Madrid. España.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sanabria', 'Affiliation': 'Centro de Investigación, Mente, Cerebro y Comportamiento. Departamento de Psicología Experimental, Universidad de Granada, España.'}]",European journal of sport science,['10.1080/17461391.2020.1781265'] 2377,32519599,Patients' and caregivers' experiences of driving with chronic breathlessness before and after regular low-dose sustained-release morphine: A qualitative study.,"BACKGROUND Chronic breathlessness is a disabling syndrome that profoundly impacts patients' and caregivers' lives. Driving is important for most people, including those with advanced disease. Regular, low-dose, sustained-release morphine safely reduces breathlessness, but little is known about its impact on driving. AIM To understand patients' and caregivers' (1) perspectives and experiences of driving with chronic breathlessness; and (2) perceived impact of regular, low-dose, sustained-release morphine on driving. DESIGN A qualitative study embedded in a pragmatic, phase III, randomised, placebo-controlled trial of low-dose, sustained-release morphine (⩽32 mg/24 h) for chronic breathlessness. Semi-structured interviews were conducted immediately after participants withdrew or completed the randomised, placebo-controlled trial. Informed by grounded theory, a constant comparative approach to analysis was adopted. SETTING/PARTICIPANTS Participants were recruited from an outpatients palliative care service in Adelaide, Australia. Participants included patients ( n  = 13) with severe breathlessness associated with chronic obstructive pulmonary disease and their caregivers ( n  = 9). RESULTS Participants were interviewed at home. Eleven received morphine 8-32 mg. Three themes emerged: (1) independence; (2) breathlessness' impact on driving; and (3) driving while taking regular, low-dose, sustained-release morphine. CONCLUSION Driving contributed to a sense of identity and independence. Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being. Patients reported breathlessness at rest may impair driving skills, while the introduction of sustained-release morphine seemed to have no self-reported impact on driving. Investigating this last perception objectively, especially in terms of safety, is the subject of ongoing work.",2020,"Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being.","['Participants included patients ( n \u2009=\u200913) with severe breathlessness associated with chronic obstructive pulmonary disease and their caregivers ( n \u2009=\u20099', 'Participants were interviewed at home', ""Patients' and caregivers' experiences of driving with chronic breathlessness before and after regular low-dose sustained-release"", 'Participants were recruited from an outpatients palliative care service in Adelaide, Australia']","['placebo', 'sustained-release morphine', 'morphine']","[""independence; (2) breathlessness' impact on driving; and (3) driving while taking regular, low-dose, sustained-release morphine""]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",,0.0508524,"Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being.","[{'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Ferreira', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Boland', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, NSW, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Honson', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, NSW, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}]",Palliative medicine,['10.1177/0269216320929549'] 2378,32519676,Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information: Randomized Experiment With Laypersons.,"BACKGROUND The written format and literacy competence of screen-based texts can interfere with the perceived trustworthiness of health information in online forums, independent of the semantic content. Unlike in professional content, the format in unmoderated forums can regularly hint at incivility, perceived as deliberate rudeness or casual disregard toward the reader, for example, through spelling errors and unnecessary emphatic capitalization of whole words (online shouting). OBJECTIVE This study aimed to quantify the comparative effects of spelling errors and inappropriate capitalization on ratings of trustworthiness independently of lay insight and to determine whether these changes act synergistically or additively on the ratings. METHODS In web-based experiments, 301 UK-recruited participants rated 36 randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider. A total of 9 control excerpts were compared with matching error-containing excerpts. Each matching error-containing excerpt included 5 instances of misspelling, or 5 instances of inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors. Data were analyzed in a linear mixed effects model. RESULTS The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100). Compared with the control excerpts, excerpts containing only misspellings were rated as being 8.86 points less trustworthy, those containing inappropriate capitalization were rated as 6.41 points less trustworthy, and those containing the combination of misspelling and capitalization were rated as 14.33 points less trustworthy (P<.001 for all). Misspelling and inappropriate capitalization show an additive effect. CONCLUSIONS Distinct indicators of incivility independently and additively penalize the perceived trustworthiness of online text independently of lay insight, eliciting a medium effect size.",2020,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,['301 UK-recruited participants rated 36'],"['inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors', 'spelling errors and inappropriate capitalization', 'randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider']",['mean trustworthiness ratings'],"[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C1005353', 'cui_str': 'Trachemys'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0768117,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,"[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Witchel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Georgina A', 'Initials': 'GA', 'LastName': 'Thompson', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Carina E I', 'Initials': 'CEI', 'LastName': 'Westling', 'Affiliation': 'Faculty of Media and Communication, Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Maag', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/15171'] 2379,32519680,"The assessment of the impact of a training process on the habituation of the vestibular-vegetative system, using a special rotational test as a condition of maintaining flight safety.","OBJECTIVES The authors formulated a hypothesis that, on completion of the training program by cadets, their vestibular habituation would increase, measured by the time of the duration of the test on the unlocked looping, in contrast to the initial values and the control group. MATERIAL AND METHODS The research involved 35 male cadets, first-year students of the Polish Air Force Academy in Dęblin. The examined persons were on average 20 years of age. They were divided into 2 groups. Group A (N = 25, tested) continued training on Special Aviation Gymnastic Instruments (SAGI). The cadets were a homogeneous group of participants in the jet pilot course, selected by the Military Aeromedical Board. Group B (N = 10, control) conducted the standard physical military education program. Groups A and B were tested on the unlocked looping before and after the training process. In the training process, the groups had heart rate (HR) monitored. RESULTS The cadets in group A on the test in the unlocked looping, at the beginning of the training period, had an average score of 468.5±96.6 s, and on completion of the training period 575.6±47.9 s, which is a statistically significant difference at p < 0.000001. Similarly, the examined individuals in group B received an average score of 396.2±31.8 s, and at the end of the training period 473.4±72.0 s, which is a statistically significant difference at p < 0.01. In group A, a statistically significant decrease in the average HR value was observed. In group B, there was a statistically significant increase in the average HR value. CONCLUSIONS The exercises on SAGI have a beneficial impact on improving the habituation of the vestibular organ in training cadets in examination II, as opposed to examination I and the control group.",2020,"In group B, there was a statistically significant increase in the average HR value. ","['35 male cadets, first-year students of the Polish Air Force Academy in Dęblin']",['standard physical military education program'],"['heart rate (HR) monitored', 'average HR value']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0000876', 'cui_str': 'Academies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",35.0,0.0136962,"In group B, there was a statistically significant increase in the average HR value. ","[{'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Wochyński', 'Affiliation': 'Polish Air Force University, Dęblin, Poland (Department of Aviation Safety Transport).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Krawczyk', 'Affiliation': 'Polish Air Force University, Dęblin, Poland (Department of Aviation).'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Cur', 'Affiliation': '3rd Airlift Wing, Powidz, Poland.'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01515'] 2380,32519824,Influence of two different methods of nutrition education on the quality of life in children and adolescents with type 1 diabetes mellitus - a randomized study.,"Background. Nutrition education is one of the most important factors determining the effectiveness of treatment and maintaining an adequate quality of life (QoL) in children and adolescents with type 1 diabetes. Material and Methods. A randomized single-blind study was conducted between October 2017 and April 2019 at the Children's Clinical Hospital in Warsaw. The study included 170 patients (aged 8-17) with at least 1-year history of type 1 diabetes, treated with insulin pumps. The participants were randomly divided into two groups: a control group (C) - traditional/ informative education methods, and an experimental group (E) - modern/interactive methods. PedsQL Diabetes Module 3.0 questionnaire was used in the assessment of the QoL. Total PedsQL score was the primary outcome. The secondary outcomes included the results obtained in five subscales of the questionnaire. The relationships between selected variables and changes in scores were also verified. Results. Data obtained from 136 patients were analyzed. In both groups no significant changes regarding total PedsQL were noted 6 months after the intervention. However, a significant reduction occurred as regards the scores of 'Communication' subscale in group C. Analyzing other determinants of the QoL, significant dependencies were observed between: the level of physical activity and a change in 'Diabetes symptoms' subscale, and the level of parents' education and a change in 'Treatment barriers' subscale. Conclusions. Both methods of nutrition education exerted a comparable influence on the total QoL. However, modern methods were more effective in terms of the improvement in the aspect of communication. Additionally, moderate physical activity and parents' tertiary education constituted valid determinants of various aspects of the QoL in children and adolescents with type 1 diabetes.",2020,In both groups no significant changes regarding total PedsQL were noted 6 months after the intervention.,"[""October 2017 and April 2019 at the Children's Clinical Hospital in Warsaw"", 'children and adolescents with type 1 diabetes', 'children and adolescents with type 1 diabetes mellitus', '170 patients (aged 8-17) with at least 1-year history of type 1 diabetes, treated with insulin pumps', '136 patients were analyzed']","['nutrition education', 'control group (C) - traditional/ informative education methods, and an experimental group (E) - modern/interactive methods', 'PedsQL Diabetes Module']","['quality of life', ""level of physical activity and a change in 'Diabetes symptoms' subscale, and the level of parents' education and a change in 'Treatment barriers' subscale"", 'total QoL', 'total PedsQL', ""scores of 'Communication' subscale""]","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",170.0,0.0326154,In both groups no significant changes regarding total PedsQL were noted 6 months after the intervention.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Dłużniak-Gołaska', 'Affiliation': 'Department of Clinical Dietetics, Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Panczyk', 'Affiliation': 'Department of Education and Research in Health Sciences, Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Pediatrics, The First Faculty of Medicine, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Sińska', 'Affiliation': 'Department of Human Nutrition, Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Szostak-Węgierek', 'Affiliation': 'Department of Clinical Dietetics, Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland.'}]",Roczniki Panstwowego Zakladu Higieny,['10.32394/rpzh.2020.0117'] 2381,32519832,The Effect of a Single Session of Plyometric Training Per Week on Fitness Parameters in Professional Female Soccer Players: A Randomized Controlled Trial.,"Nonnato, A, Hulton, AT, Brownlee, TE, and Beato, M. The effect of a single session of plyometric training per week on fitness parameters in professional female soccer players. A randomized controlled trial. J Strength Cond Res XX(X): 000-000, 2020-As the interest and popularity of female soccer has increased over the last few decades, there still lacks research conducted with the elite population, specifically ecological training interventions during the competitive season. Therefore, the aim of this study was to compare the effectiveness of 12 weeks (undertaken once a week) of plyometric (PLY) training on physical performance in professional female soccer players during the season. Using a randomized controlled trial design, 16 players were included in the current study (mean ± SD; age 23 ± 4 years, weight 60.3 ± 4.9 kg, height 167 ± 3.7 cm) and randomized in PLY (n = 8) and Control groups (CON, n = 8), respectively. Squat jump (SJ), counter movement jump (CMJ), long jump (LJ), single-leg triple jump distance test (triple jump test), changes of direction 505 test (505-COD), and sprint 10 and 30 m were performed before and after 12 weeks of PLY training. Significant within-group differences were found in triple jump test dominant (p = 0.031, effect size [ES] = moderate) and nondominant limb (p = 0.021, ES = moderate) and sprint 10 m (p = 0.05, ES = large), whereas the CON did not report any positive variation. However, neither group reported significant variation in SJ, CMJ, LJ, 505-COD, and sprint 30 m (underlining the difficulties in obtain meaningful variation in season). These findings have strong practical applications because this study showed for the first time that a single session a week of plyometric training can significantly increase sport-specific fitness parameters in professional female soccer players during the season.",2020,"Significant within-group differences were found in triple jump test dominant (p = 0.031, effect size [ES] = moderate) and nondominant limb (p = 0.021, ES = moderate) and sprint 10 m (p = 0.05, ES = large), whereas the CON did not report any positive variation.","['professional female soccer players during the season', 'professional female soccer players', 'Professional Female Soccer Players', '16 players were included in the current study (mean ± SD; age 23 ± 4 years, weight 60.3 ± 4.9 kg, height 167 ± 3.7 cm) and randomized in PLY (n = 8) and Control groups (CON, n = 8), respectively']","['J Strength Cond Res XX(X', 'Plyometric Training', 'plyometric (PLY) training', 'plyometric training', 'CON']","['Squat jump (SJ), counter movement jump (CMJ), long jump (LJ), single-leg triple jump distance test (triple jump test), changes of direction 505 test (505-COD), and sprint 10 and 30 m', 'sport-specific fitness parameters', 'SJ, CMJ, LJ, 505-COD, and sprint 30 m (underlining the difficulties in obtain meaningful variation in season', 'effect size [ES] = moderate) and nondominant limb']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",16.0,0.0518052,"Significant within-group differences were found in triple jump test dominant (p = 0.031, effect size [ES] = moderate) and nondominant limb (p = 0.021, ES = moderate) and sprint 10 m (p = 0.05, ES = large), whereas the CON did not report any positive variation.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nonnato', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk, Ipswich, United Kingdom.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hulton', 'Affiliation': 'School of Biosciences and Medicine, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Brownlee', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, LJMU, Liverpool, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Beato', 'Affiliation': 'School of Health and Sports Sciences, University of Suffolk, Ipswich, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003591'] 2382,32519878,"Response to Letter Regarding Article, ""Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial"".",,2020,,['Patients With Intermittent Claudication'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]",[],[],,0.220695,,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Djerf', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Millinger', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Falkenberg', 'Affiliation': 'Department of Radiology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Sweden (M.F.).'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Jivegård', 'Affiliation': 'HTA Centrum (Health Technology Assessment Center) Västra Götaland (L.J.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Department of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden (M.S.).'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Nordanstig', 'Affiliation': 'Department of Vascular Surgery (H.D., J.M., J.N.), Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009385'] 2383,32519889,Exercise Capacity and Ventricular Remodeling After Transcatheter Ventricular Septal Defect Closure in Asymptomatic or Minimally Symptomatic Adolescents and Adults.,"BACKGROUND Transcatheter ventricular septal defect (VSD) closure is a safe and efficacious alternative to surgery. However, its benefits in asymptomatic or minimally symptomatic patients remain unknown. METHODS Sixty patients with VSD aged 12 to 60 years underwent cardiopulmonary exercise test and echocardiography 1 day before transcatheter VSD closure and 6 months after intervention (closure group). Thirty patients who did not receive the intervention underwent the same evaluations over 6 months (observation group). RESULTS No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat). Left ventricular end-diastolic dimension and mitral peak early filling velocity-to-early diastolic annular velocity ratio decreased (absolute decrease: 0.3±0.6 cm and 0.7±1.9, respectively). Despite unchanged overall peak O 2 consumption, 33% of closure group patients exhibited clinically significant improvements in peak O 2 consumption (>10% increase relative to baseline). This was not related to the pulmonary flow-to-systemic flow ratio or baseline exercise capacity. By contrast, all exercise function parameters deteriorated significantly in the observation group. Subgroup analysis revealed that patients with a baseline left ventricular end-diastolic dimension Z score of >2 exhibited a significantly greater improvement in peak O 2 consumption, peak O 2 pulse, and oxygen uptake efficiency slope than did the observation group. CONCLUSIONS Compared with conservative management, transcatheter VSD closure prevents deterioration in exercise capacity and promotes left ventricular reverse remodeling in asymptomatic or minimally symptomatic patients. These benefits are most prominent in patients whose left ventricular end-diastolic dimension Z score before intervention is >2, irrespective of baseline peak O 2 consumption and pulmonary flow/systemic flow ratio. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03127748.",2020,"No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat).","['Thirty patients who did not receive the intervention underwent the same evaluations over 6 months (observation group', 'Asymptomatic or Minimally Symptomatic Adolescents and Adults', 'asymptomatic or minimally symptomatic patients', 'Sixty patients with VSD aged 12 to 60 years underwent']","['Transcatheter ventricular septal defect (VSD', 'transcatheter VSD closure', 'Transcatheter Ventricular Septal Defect Closure', 'cardiopulmonary exercise test and echocardiography 1 day before transcatheter VSD closure and 6 months after intervention (closure group']","['peak O 2 consumption', 'Exercise Capacity and Ventricular Remodeling', 'peak oxygen (O 2 ) pulse', 'exercise function', 'Left ventricular end-diastolic dimension and mitral peak early filling velocity-to-early diastolic annular velocity ratio', 'pulmonary flow-to-systemic flow ratio or baseline exercise capacity', 'peak O 2 consumption, peak O 2 pulse, and oxygen uptake efficiency slope']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0190023', 'cui_str': 'Closure of ventricular septal defect'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",60.0,0.0378883,"No significant change in exercise function was observed after VSD closure, except for increased peak oxygen (O 2 ) pulse (absolute increase: 0.4±1.4 mL/beat).","[{'ForeName': 'Chun-An', 'Initials': 'CA', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Jou-Kou', 'Initials': 'JK', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Ming-Tai', 'Initials': 'MT', 'LastName': 'Lin', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Hsin-Hui', 'Initials': 'HH', 'LastName': 'Chiu', 'Affiliation': 'Department of Pediatrics, Taipei Tzu Chi Hospital, New Taipei City, Taiwan (H.-H.C.).'}, {'ForeName': 'Jui-Yu', 'Initials': 'JY', 'LastName': 'Hsu', 'Affiliation': 'Dianthus MFM clinic, Taipei, Taiwan (J.-Y.H., Y.-M.C.).'}, {'ForeName': 'Shu-Man', 'Initials': 'SM', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, National Yang-Ming University, Taipei, Taiwan (S.-M.L.).'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Chang', 'Affiliation': 'Dianthus MFM clinic, Taipei, Taiwan (J.-Y.H., Y.-M.C.).'}, {'ForeName': 'Shuenn-Nan', 'Initials': 'SN', 'LastName': 'Chiu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Chun-Wei', 'Initials': 'CW', 'LastName': 'Lu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Mei-Hwan', 'Initials': 'MH', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, National Taiwan University Children's Hospital, Taipei, Taiwan (C.-A.C., J.-K.W., M.-T.L., S.-N.C., C.-W.L., M.-H.W.).""}, {'ForeName': 'Ming-Chun', 'Initials': 'MC', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, E-DA Hospital, Kaoshiung, Taiwan (M.-C.Y.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008813'] 2384,32519891,"Letter by Ng and Choong Regarding Article, ""Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial"".",,2020,,['Patients With Intermittent Claudication'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]",[],[],,0.22088,,"[{'ForeName': 'Jun Jie', 'Initials': 'JJ', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore. Division of Vascular and Endovascular Surgery, National University Heart Centre Singapore. Singapore Vascular Surgical Collaborative.'}, {'ForeName': 'Andrew M T L', 'Initials': 'AMTL', 'LastName': 'Choong', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore. Division of Vascular and Endovascular Surgery, National University Heart Centre Singapore. Singapore Vascular Surgical Collaborative.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009322'] 2385,32519957,Polidocanol versus phenol in oil injection sclerotherapy in treatment of internal hemorrhoids: A randomized controlled trial.,"BACKGROUND/AIMS Management of Haemorrhoids is suboptimal and is largely based on traditional practices in the Indian population. Though injection sclerotherapy is a well-accepted treatment modality in early grade haemorrhoids, there is no consensus on the effectiveness of the drugs used for sclerotherapy. The study was done to compare the safety and efficacy of a standard sclerosant (polidocanol) and the conventionally used phenol in oil in bleeding grade-1 and 2 internal haemorrhoids. MATERIALS AND METHODS All patients with grade-1 and 2 hemorrhoids, were selected and randomised into two groups, 3% polidocanol and 5% phenol group. All patients were followed-up for three months and observed for ""free of bleeding"" or ""persistent bleeding."" Pain, pruritus and patient satisfaction following the procedure was also assessed. RESULTS A total of 150 patients were enrolled, 75 in each group. At the end of the first sclerotherapy session with polidocanol, 60.6% of patients versus 38.1% in phenol group had stopped per rectal bleeding (p=0.009). After the second sclerotherapy session, 94.7% of patients in the polidocanol group and 84% of patients in the phenol group were treated successfully. Polidocanol group required significantly fewer treatment sessions than the phenol group (1.39±0.49 vs. 1.62±0.49; p=0.035), and the total volume of injected sclerosant was also less (3.30±0.96 mL vs. 4.86±1.46 mL; p=0.001). The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). CONCLUSION 3% polidocanol is safe and more effective than 5% phenol in oil when used as injection sclerotherapy in the treatment of first and second-degree internal hemorrhoids.",2020,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","['All patients with grade-1 and 2 hemorrhoids', 'A total of 150 patients were enrolled, 75 in each group', 'internal hemorrhoids']","['polidocanol and 5% phenol group', 'polidocanol', 'standard sclerosant (polidocanol', 'Polidocanol versus phenol in oil injection sclerotherapy', 'injection sclerotherapy', 'Polidocanol']","['Pain, pruritus and patient satisfaction', 'total volume of injected sclerosant', 'patient satisfaction', 'safety and efficacy', 'free of bleeding"" or ""persistent bleeding', 'stopped per rectal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0265034', 'cui_str': 'Internal hemorrhoids'}]","[{'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0036426', 'cui_str': 'Sclerosing agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}]",150.0,0.0796908,"The patient satisfaction was 87% in polidocanol group versus 73% in phenol group (p=0.040). ","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'Sahoo', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Thirthar Palanivelu', 'Initials': 'TP', 'LastName': 'Elamurugan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Sadasivan', 'Initials': 'S', 'LastName': 'Jagdish', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.19276'] 2386,32519966,Technical and Psychosocial Challenges of mHealth Usage for Antiretroviral Therapy Adherence Among People Living With HIV in a Resource-Limited Setting: Case Series.,"BACKGROUND Mobile communication has been found to improve antiretroviral therapy (ART) adherence among people living with HIV. In an ongoing randomized clinical trial, 2 mobile communication strategies (ie, sending SMS text messages and real-time medication monitoring [RTMM]) were used to improve adherence to ART among people living with HIV in Tanzania. We noticed remarkable discrepancies between self-reported adherence and adherence recorded by SMS text messaging or RTMM among some of the first trial participants. OBJECTIVE Our objective was to describe these cases and the observed discrepancies in more detail, to serve as a useful illustration of some of the challenges in using mobile health in resource-limited settings. METHODS In an ongoing randomized trial, adults living with HIV from two HIV treatment centers in Tanzania who were suspected of low levels of adherence were randomly assigned in a 1:1:1 ratio to receive (1) SMS text message reminders, (2) an RTMM device, or (3) no additional intervention to standard HIV care. During bimonthly study visits, the participants self-reported their level of adherence, received feedback about their level of adherence based on SMS text messaging or RTMM, and discussed strategies to overcome adherence problems with nurses providing HIV care. For the purpose of this report, we selected people living with HIV who had completed 5 follow-up visits and consistently reported more than 95% adherence, while SMS text messaging or RTMM recorded lower than 75% adherence. The participants were invited for a short, face-to-face in-depth interview to explore reasons for this discrepancy. RESULTS At the time of this analysis, 26 participants had completed follow-up. Six of these evidenced the above-mentioned discrepancies, with an average adherence of 46% based on SMS text messaging or RTMM, while self-reported adherence was 98%. Five of these 6 participants insisted that their adherence to ART was good, with 4 reporting that their adherence to properly using the monitoring device was low. Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device. Two participants were still depending on other reminder cues despite receiving SMS text message or RTMM reminders. Poor network coverage caused low adherence in 1 participant. CONCLUSIONS Psychosocial barriers were reported as importantly contributing to low adherence, both with respect to use of ART and proper use of the adherence-monitoring device. This case series illustrates that when introducing new digital adherence monitoring technology, researchers should consider psychosocial barriers and distinguish between adherence to device use and adherence to treatment. TRIAL REGISTRATION Pan African Clinical Trials Registry PACTR201712002844286; https://tinyurl.com/y98q4p3l.",2020,Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device.,"['selected people living with HIV who had completed 5 follow-up visits and consistently reported more than 95% adherence, while SMS text messaging or RTMM recorded lower than 75% adherence', 'Two participants were still depending on other reminder cues despite receiving SMS text message or RTMM reminders', 'People Living With HIV in a Resource-Limited Setting', '26 participants had completed follow-up', 'people living with HIV in Tanzania', 'people living with HIV', 'adults living with HIV from two HIV treatment centers in Tanzania who were suspected of low levels of adherence']","['mobile communication strategies (ie, sending SMS text messages and real-time medication monitoring [RTMM', 'SMS text message reminders, (2) an RTMM device, or (3) no additional intervention to standard HIV care', 'Antiretroviral Therapy']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],2.0,0.136054,Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device.,"[{'ForeName': 'Kennedy Michael', 'Initials': 'KM', 'LastName': 'Ngowi', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Furaha', 'Initials': 'F', 'LastName': 'Lyamuya', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muro', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Zawadiel', 'Initials': 'Z', 'LastName': 'Hillu', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Shirima', 'Affiliation': 'Majengo Dispensary, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Radboud Institute for Health Sciences & Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Ag Sprangers', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Pythia T', 'Initials': 'PT', 'LastName': 'Nieuwkerk', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reiss', 'Affiliation': 'Department of Global Health and Division of infectious Diseases, Amsterdam institute of Global Health and Development, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Sumari-de Boer', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}]",JMIR formative research,['10.2196/14649'] 2387,32519972,Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.,"BACKGROUND Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices. OBJECTIVE This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP). METHODS In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices. RESULTS A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices. CONCLUSIONS Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward. TRIAL REGISTRATION Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.",2020,"No differences related to psychological distress and usability were found between randomization groups or devices. ","['90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands', '60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed']","['Wearable Devices', 'continuous vital sign monitoring using VM or HP and a control group', 'two wearable devices: ViSi Mobile (VM) and HealthPatch (HP']","['feelings of safety, and VM lines and electrodes', 'State Trait Anxiety Inventory and the Pain Catastrophizing Scale', 'Psychological distress', 'psychological distress and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",90.0,0.0887291,"No differences related to psychological distress and usability were found between randomization groups or devices. ","[{'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Weenk', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Bredie', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Koeneman', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Hesselink', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'van de Belt', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/15471'] 2388,32520071,Intensive support recommendations for critically-ill patients with suspected or confirmed COVID-19 infection.,"In December 2019, a series of patients with severe pneumonia were identified in Wuhan, Hubei province, China, who progressed to severe acute respiratory syndrome and acute respiratory distress syndrome. Subsequently, COVID-19 was attributed to a new betacoronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Approximately 20% of patients diagnosed as COVID-19 develop severe forms of the disease, including acute hypoxemic respiratory failure, severe acute respiratory syndrome, acute respiratory distress syndrome and acute renal failure and require intensive care. There is no randomized controlled clinical trial addressing potential therapies for patients with confirmed COVID-19 infection at the time of publishing these treatment recommendations. Therefore, these recommendations are based predominantly on the opinion of experts (level C of recommendation).",2020,"Subsequently, COVID-19 was attributed to a new betacoronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).","['critically-ill patients with suspected or confirmed COVID-19 infection', 'patients with severe pneumonia were identified in Wuhan, Hubei province, China, who progressed to severe acute respiratory syndrome and acute respiratory distress syndrome']",[],"['acute hypoxemic respiratory failure, severe acute respiratory syndrome, acute respiratory distress syndrome and acute renal failure and require intensive care']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]",[],"[{'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",,0.183024,"Subsequently, COVID-19 was attributed to a new betacoronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).","[{'ForeName': 'Thiago Domingos', 'Initials': 'TD', 'LastName': 'Corrêa', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Gustavo Faissol Janot de', 'Initials': 'GFJ', 'LastName': 'Matos', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Bruno de Arruda', 'Initials': 'BA', 'LastName': 'Bravim', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Ricardo Luiz', 'Initials': 'RL', 'LastName': 'Cordioli', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Alejandra Del Pilar Gallardo', 'Initials': 'ADPG', 'LastName': 'Garrido', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Murillo Santucci Cesar de', 'Initials': 'MSC', 'LastName': 'Assuncao', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Carmen Silvia Valente', 'Initials': 'CSV', 'LastName': 'Barbas', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Karina Tavares', 'Initials': 'KT', 'LastName': 'Timenetsky', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Roseny Dos Reis', 'Initials': 'RDR', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Hélio Penna', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rabello Filho', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Frederico Polito', 'Initials': 'FP', 'LastName': 'Lomar', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Farah Christina de La Cruz', 'Initials': 'FCC', 'LastName': 'Scarin', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Carla Luciana', 'Initials': 'CL', 'LastName': 'Batista', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Adriano José', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'João Carlos de Campos', 'Initials': 'JCC', 'LastName': 'Guerra', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Bárbara Vieira', 'Initials': 'BV', 'LastName': 'Carneiro', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Ricardo Kenji', 'Initials': 'RK', 'LastName': 'Nawa', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Rodrigo Martins', 'Initials': 'RM', 'LastName': 'Brandão', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Antônio Eduardo Pereira', 'Initials': 'AEP', 'LastName': 'Pesaro', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Moacyr', 'Initials': 'M', 'LastName': 'Silva Júnior', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Fabricio Rodrigues Torres de', 'Initials': 'FRT', 'LastName': 'Carvalho', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Cilene Saghabi de Medeiros', 'Initials': 'CSM', 'LastName': 'Silva', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Ana Claudia Ferraz de', 'Initials': 'ACF', 'LastName': 'Almeida', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Franken', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Marcele Liliane', 'Initials': 'ML', 'LastName': 'Pesavento', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Raquel Afonso Caserta', 'Initials': 'RAC', 'LastName': 'Eid', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}, {'ForeName': 'Leonardo José Rolim', 'Initials': 'LJR', 'LastName': 'Ferraz', 'Affiliation': 'Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .'}]","Einstein (Sao Paulo, Brazil)",['10.31744/einstein_journal/2020AE5793'] 2389,32520132,Surgical cricothyroidostomy. Analysis and comparison between teaching and validation models of simulator models.,"OBJECTIVE to compare the acquisition and retention of knowledge about surgical cricothyroidostomy by the rapid four-step technique (RFST), when taught by expository lecture, low fidelity and high-fidelity simulation models. METHODS ninety medical students at UFPR in the first years of training were randomized assigned into 3 groups, submitted to different teaching methods: 1) expository lectures, 2) low-fidelity simulator model, developed by the research team or 3) high-fidelity simulator model (commercial). The procedure chosen was surgical cricothyroidostomy using the RFST. Soon after lectures, the groups were submitted to a multiple-choice test with 20 questions (P1). Four months later, they underwent another test (P2) with similar content. Analysis of Variance was used to compare the grades of each group in P1 with their grades in P2, and the grades of the 3 groups 2 by 2 in P1 and P2. A multiple comparisons test (post-hoc) was used to check differences within each factor (test and group). Statistical significance was considered when p<0.05. Statistical analysis was performed in the statistical software R version 3.6.1. RESULTS each group was composed of 30 medical students, without demographic differences between them. The mean scores of the groups of the expositive lecture, of the simulator of low fidelity model and of high-fidelity simulator model in P1 were, respectively, 75.00, 76.09, and 68.79, (p<0.05). In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). CONCLUSIONS the simulation of low fidelity model was more effective in learning and knowledge retention, being feasible for RFST cricothyroidostomy training in inexperienced students.",2020,"In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). ",['ninety medical students at UFPR in the first years of training'],"['RFST cricothyroidostomy training', 'expository lectures, 2) low-fidelity simulator model, developed by the research team or 3) high-fidelity simulator model (commercial', 'Surgical cricothyroidostomy']",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],90.0,0.0201946,"In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). ","[{'ForeName': 'Akihito Inca Atahualpa', 'Initials': 'AIA', 'LastName': 'Urdiales', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Integrated Medicine - Curitiba - PR - Brazil.'}, {'ForeName': 'Gabriela Tulio', 'Initials': 'GT', 'LastName': 'Struck', 'Affiliation': '- Federal University of Paraná, Medical Course - Curitiba - PR - Brazil.'}, {'ForeName': 'Camila Roginski', 'Initials': 'CR', 'LastName': 'Guetter', 'Affiliation': '- Federal University of Paraná, Medical Course - Curitiba - PR - Brazil.'}, {'ForeName': 'Cecilia Hissai', 'Initials': 'CH', 'LastName': 'Yaegashi', 'Affiliation': '- Cajuru University Hospital- Pontifical Catholic University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Kassio Silva', 'Initials': 'KS', 'LastName': 'Temperly', 'Affiliation': '- Pontifical Catholic University of Paraná, Course of Medicina - Curitiba - PR - Brazil.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Abreu', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Flavio Saavedra', 'Initials': 'FS', 'LastName': 'Tomasich', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Antônio Carlos Ligocki', 'Initials': 'ACL', 'LastName': 'Campos', 'Affiliation': '- Federal University of Paraná, Postgraduate Program in Surgical Clinic - Curitiba - PR - Brazil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202522'] 2390,32520316,Association of Naturalistic Administration of Cannabis Flower and Concentrates With Intoxication and Impairment.,"Importance The rapidly growing legal cannabis market includes new and highly potent products, the effects of which, to our knowledge, have not previously been examined in biobehavioral research studies because of federal restrictions on cannabis research. Objective To use federally compatible, observational methods to study high-∆9-tetrahydrocannabinol (THC) legal market forms of cannabis. Design, Setting, and Participants In this cohort study with a between-groups design that was conducted in a community and university setting, cannabis flower users and concentrate users were randomly assigned to higher- vs lower-THC products within user groups. Participants completed a baseline and an experimental mobile laboratory assessment that included 3 points: before, immediately after, and 1 hour after ad libitum legal market flower and concentrate use. Of the 133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes. Exposures Flower users were randomly assigned to use either 16% or 24% THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary. Main Outcomes and Measures Primary outcome measures included plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance. Results A total of 121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3 [10.4] years; 30 women [45%]). Concentrate users compared with flower users exhibited higher plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite) across all points. After ad libitum cannabis administration, mean plasma THC levels were 1016 (SE = 1380) μg/mL in concentrate users (to convert to millimoles per liter, multiply by 3.18) and 455 (SE = 503) μg/mL in flower users. Most neurobehavioral measures were not altered by short-term cannabis consumption. However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use. Differing outcomes for the type of product (flower vs concentrate) or potency within products were not observed. Conclusions and Relevance This study provides information about the association of pharmacological and neurobehavioral outcomes with legal market cannabis. Short-term use of concentrates was associated with higher levels of THC exposure. Across forms of cannabis and potencies, users' domains of verbal memory and proprioception-focused postural stability were primarily associated with THC administration.",2020,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","['community and university setting, cannabis flower users and concentrate users', 'Exposures\n\n\nFlower users', ""133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes"", '121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3']","['THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary', 'higher- vs lower-THC products']","[""plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite"", 'mean plasma THC levels', 'verbal memory and proprioception-focused postural stability', 'balance function', 'THC exposure', 'delayed verbal memory', 'plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0589137', 'cui_str': 'Delayed verbal memory'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",121.0,0.322435,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","[{'ForeName': 'L Cinnamon', 'Initials': 'LC', 'LastName': 'Bidwell', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Ellingson', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Hollis C', 'Initials': 'HC', 'LastName': 'Karoly', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'YorkWilliams', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Hitchcock', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Tracy', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Klawitter', 'Affiliation': 'Division of Substance Dependence, Department of Psychiatry, University of Colorado, Aurora.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sempio', 'Affiliation': 'Department of Anesthesiology, University of Colorado, Aurora.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Kent E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0927'] 2391,32520346,Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study.,"BACKGROUND Dietary Guidelines for Americans recommend the consumption of 3 servings/d of low-fat/nonfat dairy. The effects of higher dairy consumption and its fat content are unknown in patients with type 2 diabetes. OBJECTIVE Evaluate the impact of higher consumption of high- compared with low-fat dairy on glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors in patients with type 2 diabetes. METHODS We enrolled 111 subjects with type 2 diabetes (aged 58.5 ± 8.9 y, 47% females, diabetes duration 13.2 ± 8.3 y, HbA1c 8.09 ± 0.96%) who consumed <3 servings of dairy/d. We randomly assigned them into 3 groups: control group maintained baseline dairy intake, low-fat (LF) group incorporated ≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated ≥3 servings/d of HF dairy. We evaluated HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake at baseline, and after 12 and 24 wk. RESULTS At 24 wk, percent energy from saturated fat increased from baseline in the HF group by 3.6%, (95% CI: 2.2, 5.1) and decreased in the LF group by -1.9% (95% CI: -3.3, -0.4). The LF group increased their percent energy from protein by 4.5% (95% CI: 2.6, 6.4), whereas the HF group decreased their percent energy from carbohydrates by -3.4% (95% CI: -0.2, -6.7). There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk. CONCLUSION In patients with type 2 diabetes, increased dairy consumption to ≥3 servings/d compared with <3 servings/d, irrespective of its fat content, while maintaining energy intake has no effect on HbA1c, body weight, body composition, lipid profile, or BP. This trial was registered at clinicaltrials.gov as NCT02895867.",2020,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk. CONCLUSION ","['111 subjects with type 2 diabetes (aged 58.5\xa0±\xa08.9 y, 47% females, diabetes duration 13.2\xa0±\xa08.3 y, HbA1c 8.09\xa0±\xa00.96%) who consumed\xa0<3 servings of dairy/d', 'patients with type 2 diabetes']","['dairy consumption and its fat content', 'control group maintained baseline dairy intake, low-fat (LF) group incorporated\xa0≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated\xa0≥3 servings/d of HF dairy', 'high- compared with low-fat dairy']","['glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors', 'HbA1c, body weight, body composition, lipid profile, or BP', 'glycemic control and cardiovascular disease risk factors', 'percent energy from protein', 'mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP', 'dairy consumption', 'percent energy from saturated fat', 'HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",111.0,0.0619029,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk. CONCLUSION ","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Tomah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Adham', 'Initials': 'A', 'LastName': 'Mottalib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Salsberg', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Ashrafzadeh', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pober', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Eldib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Mhd Wael', 'Initials': 'MW', 'LastName': 'Tasabehji', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa138'] 2392,32520354,Autologous bone marrow cell transplantation in the treatment of HIV patients with compensated cirrhosis.,"Liver stem cell therapy is a promising tool to improve decompensated liver cirrhosis (DLC). Especially in patients infected with human immunodeficiency virus (HIV), the condition of the liver may be aggravated by antiretroviral therapy. A total of 21 patients diagnosed with DLC and HIV infection were divided into two groups as follows: those who received (combination therapy group, 14 patients) and those who did not receive (routine therapy group, 7 patients) bone marrow cell transplantation through the portal vein. Two patients died of surgery-related complications in the combination therapy group. The results showed that the survival rate was 85.7% in the combination therapy group after 2 years of follow-up, which was significantly higher than the 14.3% in the conventional therapy group (P<0.01). After treatment, the liver function score decreased significantly in the combination therapy group at 1 (t=4.276, P=0.000), 3 (t=9.153, P=0.000), and 12 (t=13.536, P=0.000) months, the levels of albumin were significantly increased, and the total bilirubin level and prothrombin time were significantly reduced or shortened as compared to the routine therapy group (P<0.05 or <0.01). The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01). In summary, the combination therapy is effective in HIV-infected patients with DLC and useful for the recovery of liver function and cellular immune function but may increase the risk of severe complications after surgery.",2020,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","['patients infected with human immunodeficiency virus (HIV', 'HIV patients with compensated cirrhosis', '21 patients diagnosed with DLC and HIV infection']","['Liver stem cell therapy', 'Autologous bone marrow cell transplantation', 'bone marrow cell transplantation through the portal vein']","['total bilirubin level and prothrombin time', 'liver function score', 'levels of albumin', 'white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels', 'survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1258861', 'cui_str': 'Transplantation, Bone Marrow Cell'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}]","[{'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",21.0,0.0173503,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","[{'ForeName': 'Baochi', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Shanghai Public Health Clinical Center; Fudan University, Shanghai, China.'}, {'ForeName': 'Mingrong', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': ""Jiading Branch of Shanghai First People's Hospital, Shanghai, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Shanghai Public Health Clinical Center; Fudan University, Shanghai, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'Shanghai Public Health Clinical Center; Fudan University, Shanghai, China.'}, {'ForeName': 'Shijia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences/Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Bioscience reports,['10.1042/BSR20191316'] 2393,32520410,"First-in-human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of SAR247799, a selective G-protein-biased Sphingosine-1 phosphate receptor-1 agonist for endothelial protection.","AIM SAR247799 is a selective G-protein-biased sphingosine-1 phosphate receptor-1 (S1P 1 ) agonist with potential to restore endothelial function in vascular pathologies. SAR247799, a first-in-class molecule differentiated from previous S1P 1 -desensitizing molecules developed for multiple sclerosis, can activate S1P 1 without desensitization and consequent lymphopenia. The aim was to characterize SAR247799 for its safety, tolerability, pharmacokinetics and pharmacodynamics (activation and desensitization). METHODS SAR247799 was administered orally to healthy subjects in a double-blind, randomized, placebo-controlled study with single (2.5-37.5 mg) or 2-week once-daily (0.5-15 mg) doses. An open-label single dose pilot food-interaction arm with 10 mg SAR247799 in cross-over design was also performed. RESULTS SAR247799 was well tolerated and, at the higher end of the dose ranges, caused the expected dose-dependent pharmacodynamics associated with S1P 1 activation (heart rate reduction) and S1P 1 desensitization (lymphocyte count reduction). SAR247799 demonstrated dose-proportional increases in exposure and was eliminated with an apparent terminal half-life of 31.2-33.1 hours. Food had a small effect on the pharmacokinetics of SAR247799. SAR247799 had a low volume of distribution (7-23 L), indicating a potential to achieve dose separation for endothelial versus cardiac S1P 1 activation pharmacology. A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1 activation without tachyphylaxis. Sub-lymphocyte-reducing doses (≤ 5 mg) of SAR247799, which based on preclinical data are projected to activate S1P 1 and exhibit endothelial-protective properties, had minimal-to-no heart rate reduction and displayed no marked safety findings. CONCLUSION SAR247799 is suitable for exploring the biological role of endothelial S1P 1 activation without causing receptor desensitization.",2020,"A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1 activation without tachyphylaxis.",['healthy subjects'],"['placebo', 'SAR247799']","['safety, tolerability, pharmacokinetics and pharmacodynamics (activation and desensitization', 'sustained heart rate reduction', 'safety, tolerability, pharmacokinetics and pharmacodynamics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0378777,"A supratherapeutic dose (10 mg) of SAR247799 produced sustained heart rate reduction over 14 days, demonstrating cardiac S1P 1 activation without tachyphylaxis.","[{'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bergougnan', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Armani', 'Affiliation': 'Parexel International GmBH, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmBH, Berlin, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tardat', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vitse', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Hurbin', 'Affiliation': 'Sanofi R&D, 371 Rue du Professeur Blayac, 34080, Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Scemama', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Poitiers', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Radzik', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Gaudin', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Hovsepian', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Muslin', 'Affiliation': 'Sanofi US Services, 640 Memorial Drive, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Kirkesseli', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385, Chilly Mazarin, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deutsch', 'Affiliation': 'Sanofi US Services, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.'}, {'ForeName': 'Ashfaq A', 'Initials': 'AA', 'LastName': 'Parkar', 'Affiliation': 'Sanofi US Services, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14422'] 2394,32520418,Grapefruit juice enhances the systolic blood pressure-lowering effects of dietary nitrate-containing beetroot juice.,"INTRODUCTION Dietary nitrate from sources such as beetroot juice lowers blood pressure (BP) via the nitrate-nitrite-nitric oxide (NO) pathway. However, NO and nitrite are inactivated via re-oxidation to nitrate, potentially limiting their activity. Cytochrome P450-3A4 inhibition with troleandomycin prevents nitrite re-oxidation to nitrate in rodent liver. Grapefruit juice contains the CYP3A4 inhibitor furanocoumarin. We therefore hypothesized that grapefruit juice would enhance BP-lowering with beetroot juice by maintaining circulating [nitrite]. METHODS We performed a randomized, placebo-controlled, 7-hour crossover study in 11 healthy volunteers, attending on 3 occasions, receiving: a 70ml-shot of active beetroot juice (Beet-It®) and either (i) 250 ml grapefruit juice (""Active Beet+GFJ""), or (ii) 250 ml water (Buxton®, ""Active Beet+H 2 O""); or (iii) Placebo Beet+GFJ. RESULTS The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ versus Active Beet+H 2 O (P=0.02), and pulse pressure, PP (P=0.0003). Peak mean differences in SBP and PP were seen at T=5 hours: -3.3mmHg (95% CI -6.43 to -0.15) and at T=2.5 hours: -4.2 mmHg (95% CI -0.3 to -8.2), respectively. Contrary to the hypothesis, plasma [nitrite] was lower with Active Beet+GFJ versus Active Beet+H 2 O (P=0.006), as was salivary nitrite production (P=0.002) and saliva volume (-0.34 ml/min (95% CI -0.05 to -0.68)). The taste score of Beet+GFJ was 1.4/10 points higher than Beet+H 2 O (P=0.03). CONCLUSIONS Grapefruit juice enhanced beetroot juice's effect on lowering SBP and PP despite decreasing plasma [nitrite]. Besides suggesting more complex mechanisms, there is potential for maximising the clinical benefit of dietary nitrate and targeting isolated systolic hypertension.",2020,"The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ versus Active Beet+H 2 O (P=0.02), and pulse pressure, PP (P=0.0003).","['11 healthy volunteers, attending on 3 occasions, receiving: a 70ml-shot of active beetroot juice (Beet-It®) and either (i) 250']","['troleandomycin', 'ml grapefruit juice (""Active Beet+GFJ""), or (ii) 250 ml water (Buxton®, ""Active Beet+H 2 O""); or (iii) Placebo Beet+GFJ', 'dietary nitrate-containing beetroot juice', 'Grapefruit juice', 'placebo']","['plasma [nitrite', 'blood pressure (BP', 'saliva volume', 'systolic blood pressure', 'taste score of Beet+GFJ', 'salivary nitrite production', 'systolic BP (SBP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0330391', 'cui_str': 'Beta vulgaris'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0041165', 'cui_str': 'Troleandomycin'}, {'cui': 'C0452456', 'cui_str': 'GRAPEFRUIT JUICE'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",11.0,0.119771,"The addition of grapefruit juice to active beetroot juice lowered systolic BP (SBP): Active Beet+GFJ versus Active Beet+H 2 O (P=0.02), and pulse pressure, PP (P=0.0003).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': ""O'Gallagher"", 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borg Cardona', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Callum', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Saedi', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shahed', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Floyd', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McNeill', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Mills', 'Affiliation': ""Biomedical Research Centre, Clinical Research Facility, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre of Research Excellence, London, UK.""}]",British journal of clinical pharmacology,['10.1111/bcp.14420'] 2395,31973631,"Effects of graduated compression stockings, local vibration and their combination on popliteal venous blood velocity.","OBJECTIVES The purpose of this pilot study was to examine and compare the effects of graduated compression stockings, local vibration, and combined graduated compression stockings and local vibration on popliteal venous blood velocity. METHOD Twenty-four healthy subjects received four 15 min interventions (control, graduated compression stockings alone, local vibration alone, and combined graduated compression stockings and local vibration), while resting inactive in the prone position. Popliteal vein blood velocity was investigated before (PRE) and at the end (POST) of each intervention using Doppler ultrasound. RESULTS At POST, peak velocity was reported to be 26.3 ± 53.5% ( p  <   0.05) greater for local vibration than control (CONT). Peak velocity was 46.2 ± 54.6% ( p  <   0.001) and 21.1 ± 37.6% ( p  <   0.01) higher for graduated compression stockings than CONT and local vibration, respectively. Graduated compression stockings + local vibration presented 64.1 ± 58.0% ( p  <   0.001), 38.4 ± 52.4% ( p  <   0.001) and 15.0 ± 31.6% ( p  <   0.05) greater values than CONT, local vibration and graduated compression stockings, respectively. CONCLUSIONS This study demonstrated an increase in popliteal venous blood velocity after graduated compression stockings and local vibration application. Their combination provided the greatest effects.",2020,"Graduated compression stockings + local vibration presented 64.1 ± 58.0% ( p  <   0.001), 38.4 ± 52.4% ( p  <   0.001) and 15.0 ± 31.6% ( p  <   0.05) greater values than CONT, local vibration and graduated compression stockings, respectively. ",['Twenty-four healthy subjects'],"['graduated compression stockings, local vibration, and combined graduated compression stockings and local vibration', '15\u2009min interventions (control, graduated compression stockings alone, local vibration alone, and combined graduated compression stockings and local vibration', 'graduated compression stockings, local vibration and their combination']","['Popliteal vein blood velocity', 'peak velocity', 'Peak velocity', 'popliteal venous blood velocity', 'local vibration']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032652', 'cui_str': 'Structure of popliteal vein'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]",24.0,0.0238083,"Graduated compression stockings + local vibration presented 64.1 ± 58.0% ( p  <   0.001), 38.4 ± 52.4% ( p  <   0.001) and 15.0 ± 31.6% ( p  <   0.05) greater values than CONT, local vibration and graduated compression stockings, respectively. ","[{'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Espeit', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lapole', 'Affiliation': 'Univ Lyon, UJM Saint-Etienne, Laboratoire Interuniversitaire de Biologie de la Motricité, Saint-Etienne, France.'}]",Phlebology,['10.1177/0268355520902000'] 2396,32228137,The Effects of Expert and Augmented Feedback on Learning a Complex Medical Skill.,"Many medical skills are complex due to their requirements for integration of declarative (biomedical) knowledge with perceptual-motor and perceptual-cognitive proficiency. While feedback generally helps learners guide their actions, it is unclear how feedback supports the integration of declarative knowledge with skills. Thus, we investigated the effect of expert and augmented feedback on acquisition and retention of a complex medical skill (acquiring a transthoracic echocardiogram) in a simulation study. We randomly assigned 36 medical undergraduate students to one of three feedback sources: Expert (EF), Augmented visual (HS), and Expert plus Help Screen (EF + HS). Participants practiced until reaching proficiency. Outcome measures (knowledge test and practical skill ratings on a 5-point scale), were gathered at initial acquisition and at retention after 11 days, the time needed to obtain the images and the quality of images obtained. We divided the knowledge test into three topics: names of the images, manipulation of the probe, and anatomy of the heart. At acquisition, immediately after training, EF group participants were faster at obtaining images than participants in the two other groups. On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality. Thus, expert feedback best assisted initial acquisition and combined augmented and expert feedback best assisted retention of this complex medical task. Expert assistance reduced learners' cognitive load during initial practice, helping learners integrate declarative knowledge with physical skills.",2020,"On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality.",['36 medical undergraduate students to one of three'],"['feedback sources: Expert (EF), Augmented visual (HS), and Expert plus Help Screen (EF\u2009+\u2009HS', 'Expert and Augmented Feedback']","['time needed to obtain the images and the quality of images obtained', 'Outcome measures (knowledge test and practical skill ratings on a 5-point scale']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",36.0,0.0200039,"On the retention test, there were no group differences for speed of obtaining images, but the EF + HS group scored significantly higher than the other two groups on image quality.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cecilio-Fernandes', 'Affiliation': 'Center for Education Development and Research in Health Professions, research group LEARN, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'Fokie', 'Initials': 'F', 'LastName': 'Cnossen', 'Affiliation': 'Institute of Artificial Intelligence and Cognitive Engineering, University of Groningen.'}, {'ForeName': 'Jenifer', 'Initials': 'J', 'LastName': 'Coster', 'Affiliation': 'Department of Cardiology, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'Ad Debbie C', 'Initials': 'ADC', 'LastName': 'Jaarsma', 'Affiliation': 'Center for Education Development and Research in Health Professions, research group LEARN, University of Groningen and University Medical Center Groningen.'}, {'ForeName': 'René A', 'Initials': 'RA', 'LastName': 'Tio', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.'}]",Perceptual and motor skills,['10.1177/0031512520914680'] 2397,29926432,Using Film to Disseminate Information on Cervical Cancer Prevention in Lusaka: Results from a Small Intervention Study.,"In order to prevent the spread of cervical cancer, people must be aware and knowledgeable about the available preventive practices such as screening and vaccination. The purpose of this study was to determine the extent that film is effective in disseminating information on cervical cancer and its prevention to women and men in Lusaka. A pilot intervention study was carried out at churches in Lusaka city from August to September 2017. A sample size of 38 women and 43 men filled in both baseline and follow-up questionnaires. A knowledge grade (range, 1-10 points) which linked causes to risk factors for cervical cancer was used to assess the knowledge of a respondent. Significant results (p < 0.01) were obtained at follow-up for watching the film and having awareness and knowledge. The main finding is that a short informational film can be an effective means of disseminating information on cervical cancer and its prevention to women and men.",2019,Significant results (p < 0.01) were obtained at follow-up for watching the film and having awareness and knowledge.,"['churches in Lusaka city from August to September 2017', 'Cervical Cancer Prevention in Lusaka', '38 women and 43 men filled in both baseline and follow-up questionnaires', 'women and men in Lusaka']",[],[],"[{'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],[],38.0,0.0193975,Significant results (p < 0.01) were obtained at follow-up for watching the film and having awareness and knowledge.,"[{'ForeName': 'Anayawa', 'Initials': 'A', 'LastName': 'Nyambe', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. anayawa@gmail.com.'}, {'ForeName': 'Jarl K', 'Initials': 'JK', 'LastName': 'Kampen', 'Affiliation': 'Biometris, Wageningen University, Wageningen, Netherlands.'}, {'ForeName': 'Stridutt K', 'Initials': 'SK', 'LastName': 'Baboo', 'Affiliation': 'Department of Public Health and Tropical Medicine, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Van Hal', 'Affiliation': 'Department of Epidemiology and Social Medicine, University of Antwerp, Antwerp, Belgium.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1383-z'] 2398,30222051,Lolland-Falster Health Study: Study protocol for a household-based prospective cohort study.,"Introduction: Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population. It is a mixed rural-provincial area with approximately 100,000 inhabitants. The Lolland-Falster Health Study was initiated to gain knowledge on the determinants of health in this disadvantaged area. Methods: The study is a household-based prospective cohort study including people of all ages. The entire household of randomly selected inhabitants is allocated either to an invited group or to an uninvited, non-contacted control group. The data collection encompasses questionnaires, physical examination and biological samples, i.e. blood and urine for same-day analysis and biobank storage, and saliva and faeces also for biobank storage. The civil registration number links collected data for each individual, family and household, with information in Danish registers. The data collection started in February 2016 and is estimated to end by 2019 after the enrolment of 20,000 people. Analysis: A number of in-depth sub-studies are planned. Emphasis will be given to analysis of intra- and inter-family variations in health determinants, genetics, lifestyle and health status. Ethics: Region Zealand's Ethical Committee on Health Research (SJ-421) and the Danish Data Protection Agency (REG-24-2015) approved the study. Trial registration: Clinicaltrials.gov (NCT02482896). Strength and limitations of this study: The strength of this study is that Lolland-Falster Health Study is a useful scientific resource for investigating cross-sectional difference and time trends within and between individuals, families and households. LOFUS adds diversity to the previously collected Danish population studies in urbanized areas. The limitation is that data collection is expensive. Conclusions: LOFUS will contribute to the knowledge on health in disadvantaged, rural-provincial areas.",2020,Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population.,"['household-based prospective cohort study including people of all ages', 'Lolland-Falster Health Study']",['LOFUS'],[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0607072,Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population.,"[{'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Jepsen', 'Affiliation': 'Lolland-Falster Health Study, Nykøbing Falster Hospital, Nykøbing F., Denmark.'}, {'ForeName': 'Cecilie Lindström', 'Initials': 'CL', 'LastName': 'Egholm', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'Centre of Research and Education in General Practice, Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Simonsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Grarup', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Cyron', 'Affiliation': 'Medical Department, Amager and Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ellervik', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}, {'ForeName': 'Knud', 'Initials': 'K', 'LastName': 'Rasmussen', 'Affiliation': 'Production, Research and Innovation, Region Zealand, Sorø, Denmark.'}]",Scandinavian journal of public health,['10.1177/1403494818799613'] 2399,30534955,"A Preliminary Clinical Trial Comparing Split Treatments to the Face and Hand With Autologous Fat Grafting and Platelet-Rich Plasma (PRP): A 3D, IRB-Approved Study.","BACKGROUND Numerous methodologies have been suggested to enhance fat graft survival, but few long-term studies are available. OBJECTIVES The authors of this institutional review board-approved study investigated the safety and efficacy of utilizing platelet-rich plasma (PRP). METHODS Each of 10 patients received equal volumes of syringe-harvested, centrifuged fat to opposing midfaces with a lateral submuscular aponeurotic system-plication or no face lift and hands that were combined with equal volumes of either concentrated PRP or normal saline. Comparable assessments of fat retention/baseline values by 3D Vectra Analysis, VISIA, and Cortex facial skin analyses were performed. Clinical results were judged on a visual analogue scale. RESULTS The average percent change in mean volume assessments at the fat/PRP sites from baseline values, as profiled by 3D Vectra Analysis, demonstrated a higher, but statistically nonsignificant value over 1 year than the percent value changes at the fat/normal saline sites in the opposing face or hand. Three independent evaluators were able to assess volume restorations to the malar fat pad, naso-jugal groove, and nasolabial fold as well as to intermetacarpal hollowness with reduction of visible veins and tendons in the anterior midface and hands with both treatments. No adverse events were observed over the year-long study. Perioperative edema, erythema, bruising, and tenderness lasted up to 1 to 2 weeks at most. CONCLUSIONS Autologous fat grafting continues to be a safe and effective adjunct in facial and hand aesthetic surgery. This study will require more patients and longer follow-up periods to determine whether PRP has a potential role to increase fat graft retention in aesthetic patients. LEVEL OF EVIDENCE: 3 ",2019,No adverse events were observed over the year-long study.,['10 patients received'],"['Autologous Fat Grafting and Platelet-Rich Plasma (PRP', 'utilizing platelet-rich plasma (PRP', 'PRP', 'equal volumes of syringe-harvested, centrifuged fat to opposing midfaces with a lateral submuscular aponeurotic system-plication or no face lift and hands that were combined with equal volumes of either concentrated PRP or normal saline']","['fat graft survival', 'visual analogue scale', 'fat retention/baseline values by 3D Vectra Analysis, VISIA, and Cortex facial skin analyses', 'Perioperative edema, erythema, bruising, and tenderness', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0179834', 'cui_str': 'Centrifuge'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035519', 'cui_str': 'Facial rhytidoplasty'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0964960', 'cui_str': 'liquid crystal polymer'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0406158,No adverse events were observed over the year-long study.,"[{'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Sasaki', 'Affiliation': 'Department of Plastic Surgery, Loma Linda Medical University, Loma Linda, CA.'}]",Aesthetic surgery journal,['10.1093/asj/sjy254'] 2400,30817466,Optimal SBP targets in routine clinical care.,"OBJECTIVE Compare outcomes of intensive treatment of SBP to less than 120 mmHg versus standard treatment to less than 140 mmHg in the US clinical Systolic Blood Pressure Intervention Trial (SPRINT) with similar hypertensive patients managed in routine primary care in the United Kingdom. METHODS Hypertensive patients aged 50-90 without diabetes or chronic kidney disease (CKD) were selected in SPRINT and The Health Improvement Network (THIN) database. Patients were enrolled in 2010-2013 and followed-up to 2015 (SPRINT N = 4112; THIN N = 8631). Cox's proportional hazards regressions were fitted to estimate the hazard of all-cause mortality or CKD (main adverse effect) associated with intensive treatment, adjusted for sex, age, ethnicity, smoking, blood pressure, cardiovascular disease, aspirin, statin, number of antihypertensive drugs at baseline, change in number of antihypertensive drugs at trial entry, and clinical site. RESULTS Almost half of the patients had intensive treatment (43-45%). In SPRINT, intensive treatment was associated with a decreased hazard of mortality of 0.63 (0.43-0.92), while in THIN with an increased hazard of 1.66 (1.28-2.15). In THIN, this effect was time-dependent. Intensive treatment was associated with an increased hazard of CKD of 2.67 (1.74-4.11) in SPRINT and 1.35 (1.08-1.70) in THIN. In THIN, this effect differed by the number of antihypertensive drugs prescribed at baseline. CONCLUSION It appears that intensive treatment of SBP may be harmful in the general population where all have access to routine healthcare as with the UK National Health Services, but could be beneficial in high-risk patients who are closely monitored.",2019,Intensive treatment was associated with an increased hazard of CKD of 2.67 (1.74-4.11) in SPRINT and 1.35 (1.08-1.70) in THIN.,"['Hypertensive patients aged 50-90 without diabetes or chronic kidney disease (CKD', 'SBP to less than 120\u200ammHg versus standard treatment to less than 140\u200ammHg in the US clinical Systolic Blood Pressure Intervention Trial (SPRINT) with similar hypertensive patients managed in routine primary care in the United Kingdom', 'Patients were enrolled in 2010-2013 and followed-up to 2015 (SPRINT N\u200a=\u200a4112; THIN N\u200a=\u200a8631']",[],"['hazard of CKD', 'hazard of mortality']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",[],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0865356,Intensive treatment was associated with an increased hazard of CKD of 2.67 (1.74-4.11) in SPRINT and 1.35 (1.08-1.70) in THIN.,"[{'ForeName': 'Lisanne A', 'Initials': 'LA', 'LastName': 'Gitsels', 'Affiliation': 'School of Computing Sciences.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Kulinskaya', 'Affiliation': 'School of Computing Sciences.'}, {'ForeName': 'Ilyas', 'Initials': 'I', 'LastName': 'Bakbergenuly', 'Affiliation': 'School of Computing Sciences.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Steel', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}]",Journal of hypertension,['10.1097/HJH.0000000000001947'] 2401,30933748,Predictors of attendance and dropout in three randomized controlled trials of PTSD treatment for active duty service members.,"Dropout from first-line posttraumatic stress disorder (PTSD) treatments is a significant problem. We reported rates and predictors of attendance and dropout in three clinical trials of evidence-based PTSD treatments in military service members (N = 557). Service members attended 81.0% of treatment sessions and 30.7% dropped out. Individually delivered treatment was associated with greater attendance rates (β = 0.23, p < .001) than group therapy; trauma-focused treatments were associated with higher dropout (β = 0.19, p < .001) than Present-Centered Therapy. Age was a significant predictor of session attendance (β = 0.17, p < .001) and drop out (β = -0.23, p < .001). History of traumatic brain injury (TBI) predicted lower attendance rates (β = -0.26, p < .001) and greater dropout (β = 0.19, p < .001). Regardless of treatment type or format, patients who did not drop out were more likely to experience clinically significant gains (d = 0.49, p < .001). Results demonstrate that dropout from PTSD treatments in these trials was significantly associated with treatment outcome and suggest that strategies are needed to mitigate dropout, particularly in group and trauma-focused therapies, and among younger service members and those with TBI.",2019,"Individually delivered treatment was associated with greater attendance rates (β = 0.23, p < .001) than group therapy; trauma-focused treatments were associated with higher dropout (β = 0.19, p < .001) than Present-Centered Therapy.","['active duty service members', 'military service members (N\u202f=\u202f557']",['PTSD'],"['session attendance', 'attendance rates']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0735453,"Individually delivered treatment was associated with greater attendance rates (β = 0.23, p < .001) than group therapy; trauma-focused treatments were associated with higher dropout (β = 0.19, p < .001) than Present-Centered Therapy.","[{'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Berke', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA. Electronic address: db2800@hunter.cuny.edu.'}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'Kline', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Boston, MA, USA. Electronic address: nkline@clarku.edu.'}, {'ForeName': 'Jennifer Schuster', 'Initials': 'JS', 'LastName': 'Wachen', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA; National Center for PTSD, VA Boston Healthcare System, Boston, MA, USA. Electronic address: jennifer.wachen@va.gov.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, VA Palo Alto Healthcare System, Menlo Park, CA, USA; Stanford University School of Medicine, Stanford, CA, USA. Electronic address: carmen.mclean4@va.gov.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Fort Hood, TX, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: mintz@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Research and Development Service, South Texas Veterans Health Care System, San Antonio, TX, USA; Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA. Electronic address: foa@pennmedicine.upenn.edu.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Duke University Medical Center, USA. Electronic address: patricia.resick@duke.edu.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Boston, MA, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA; Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA. Electronic address: brett.litz@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Behaviour research and therapy,['10.1016/j.brat.2019.03.003'] 2402,31645444,Cross-Reactive CD8 T-Cell Responses Elicited by Adenovirus Type 5-Based HIV-1 Vaccines Contributed to Early Viral Evolution in Vaccine Recipients Who Became Infected.,"Because of HIV's vast sequence diversity, the ability of the CD8 T-cell response to recognize several variants of a single epitope is an important consideration for vaccine design. Cross-recognition of viral epitopes by CD8 T cells is associated with viral control during HIV-1 infection, but little is known about CD8 cross-reactivity in the context of HIV-1 vaccination. Here, we evaluated vaccine-induced CD8 cross-reactivity in two preventative HIV-1 vaccine efficacy trials, the MRKAd5 and DNA/rAd5 studies. Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection. Although responses directed against variant epitopes were less avid than responses to vaccine-matched epitopes, we did not detect any difference in response polyfunctionality (the proportion of cells producing multiple effector molecules). And while depth, or the frequency of cross-reactive responses, did not correlate with viral loads in recipients who became infected, cross-reactivity did appear to influence early viral evolution. In comparing viral sequences of placebo versus vaccine recipients, we found that viral sequences from vaccinees encoded CD8 epitopes with more substitutions and greater biochemical dissimilarity. In other words, breakthrough sequences of vaccinees would be less cross-recognized by vaccine-induced responses. Additionally, vaccine-induced CD8 T cells poorly cross-recognized variant epitopes encoding HLA-I-associated adaptations, further supporting our conclusion that these responses play a role in driving early HIV-1 viral evolution. IMPORTANCE HIV-1 has exceptionally high sequence diversity, much of which is found within CD8 epitopes. Therefore, the ability of CD8 T cells to recognize multiple versions of a single epitope could be important for an effective vaccine. Here, we show that two previously tested vaccines induced a similar level of CD8 cross-reactivity to that seen in acute HIV-1 infection. Although this cross-reactivity did not seem to affect viral control in vaccine recipients who became infected, we identified several ways in which CD8 cross-reactivity appeared to influence HIV-1 viral evolution. First, we saw that strains isolated from infected vaccine recipients would likely be poorly cross-recognized by the vaccine-induced response. Second, we saw that adapted CD8 epitopes were poorly cross-recognized in both vaccination and infection. Collectively, we believe these results show that CD8 cross-reactivity could be an important consideration in future HIV-1 vaccine design.",2020,Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection.,['Vaccine Recipients'],['placebo'],['Cross-Reactive CD8 T-Cell Responses'],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}]",2.0,0.0438501,Cross-reactive CD8 responses elicited by vaccination were similar in magnitude and frequency to those induced during acute HIV-1 infection.,"[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Boppana', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fiore-Gartland', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA pgoepfert@uabmc.edu.'}]",Journal of virology,['10.1128/JVI.01632-19'] 2403,31814419,Music Training Improves Depressed Mood Symptoms in Elderly People: A Randomized Controlled Trial.,"The effectiveness of music training on depressed mood and general cognitive function in elderly participants is verified in this study. Music activities consisted of improvisation exercises for stimulating interpersonal skills, mood, and cognitive functions. A mixed research method was adopted, including standardized measures (Mini-Mental State Examination and Geriatric Depression Scale) and follow-up semistructured interviews. The research design included pre- and postevaluation with randomized experimental and control groups. Participants were 45 care residents aged 62 to 95, healthy and with cognitive impairment. Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t  = 1.450; p  < .005; d  = 0.453) while the control group had no improvement ( t  = 0.080; p  > .1; d  = 0.025). In addition, a significant improvement was found in the cognitive level (Mini-Mental State Examination) for the experimental ( t  = 2.300; p  < .005; d  =   0.668) than the control group that had a significant reduction ( t  = 1.240; p  < .05; d  = 0.273). This study provides evidence that music training has a positive impact on depressed mood and general cognitive function in elderly participants. These types of music training sessions could provide aid to control the symptoms of depression, delay the deterioration of cognitive function, and enhance social-cognitive function, especially in individuals presenting with cognitive impairment.",2019,Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t  = 1.450; p  < .005; d  = 0.453) while the control group had no improvement ( t  = 0.080; p  > .1; d  = 0.025).,"['individuals presenting with cognitive impairment', 'Elderly People', 'elderly participants', 'Participants were 45 care residents aged 62 to 95, healthy and with cognitive impairment']","['music training sessions', 'music training', 'Music Training', 'Music activities consisted of improvisation exercises']","['standardized measures (Mini-Mental State Examination and Geriatric Depression Scale', 'stimulating interpersonal skills, mood, and cognitive functions', 'depressed mood and general cognitive function', 'cognitive level (Mini-Mental State Examination', 'depression index (Geriatric Depression Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0360057,Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t  = 1.450; p  < .005; d  = 0.453) while the control group had no improvement ( t  = 0.080; p  > .1; d  = 0.025).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Biasutti', 'Affiliation': 'Department of Philosophy, Sociology, Pedagogy, and Applied Psychology, University of Padova, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mangiacotti', 'Affiliation': 'Department of Philosophy, Sociology, Pedagogy, and Applied Psychology, University of Padova, Italy.'}]",International journal of aging & human development,['10.1177/0091415019893988'] 2404,31820274,Dalfampridine to Improve Balance in Multiple Sclerosis: Substudy from a Randomized Placebo-Controlled Trial.,"This was a substudy of a randomized, double-blind, placebo-controlled trial originally designed to explore the effect of dalfampridine on information processing speed (2013-002558-64 EU Clinical Trials Register) in patients with multiple sclerosis (MS). A total of 120 patients were originally randomized in a 2:1 ratio to receive dalfampridine 10 mg or placebo twice daily for 12 weeks. Here, we sought to explore the effect of dalfampridine on static balance in single-task and dual-task conditions in a subgroup of 41 patients. They underwent static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task) at randomization (baseline), after 12 weeks and after a 4-week wash-out period. Baseline characteristics of active group (n = 27) did not differ from those of placebo group (n = 14). Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2 = 0.122-0.162). The beneficial effect of dalfampridine was not retained 4 weeks after its discontinuation. The rate of accidental falls per month did not differ between the two groups (p = 0.12). Our preliminary findings suggest that dalfampridine can be considered a potential option to treat balance impairment due to MS. Larger sample sizes are needed to verify if the beneficial effect of dalfampridine on balance can be translated into a reduced risk of accidental falls.",2020,"Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2 = 0.122-0.162).","['A total of 120 patients', 'a subgroup of 41 patients', 'patients with multiple sclerosis (MS', 'Multiple Sclerosis']","['Placebo', 'static posturography in quiet standing (single-task) and while performing the Stroop test (dual-task', 'dalfampridine 10 mg or placebo', 'dalfampridine', 'Dalfampridine', 'placebo']","['balance control', 'rate of accidental falls', 'static balance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2732148', 'cui_str': 'dalfampridine 10 MG'}, {'cui': 'C0000477', 'cui_str': 'dalfampridine'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",120.0,0.478695,"Dalfampridine treatment was associated with better balance control than placebo in both single-task (F = 4.80, p = 0.034) and dual-task (F = 6.42, p = 0.015) conditions, with small-to-moderate effect sizes (Cohen's f 2 = 0.122-0.162).","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Prosperini', 'Affiliation': 'Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Castelli', 'Affiliation': 'Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Fondazione Don Carlo Gnocchi, -, Piazzale Morandi 6, 20121, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Giglio', 'Affiliation': 'Neurology Unit, S. Filippo Neri Hospital, Via G. Martinotti 20, 00135, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Bonanno', 'Affiliation': 'S. Andrea Hospital, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gasperini', 'Affiliation': 'Dept. of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'S. Andrea Hospital, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-019-00813-5'] 2405,32518480,The First Additional Port During Single-Incision Laparoscopic Cholecystectomy.,"Background and Objectives Single-incision laparoscopic cholecystectomy (SILC) has become increasingly popular. Regarding the difficulties of SILC in acute cholecystitis, additional port insertion is sometimes required. However, appropriate locations for additional port insertion have not been well studied. In the present study, the safety and effectiveness of the first additional port insertion in the epigastric region during SILC was assessed. Methods Additional port insertions were needed in 52 of 113 patients who underwent SILC for acute cholecystitis. The first port was inserted in the epigastric region and the second (if required) was inserted in the right lateral subcostal area. A drainage catheter was positioned through the epigastric port. Results One additional port was inserted in 43 patients and two additional ports were inserted in 9 patients. Mean operation time was 45.0 minutes in the Pure SILC group and 83.3 minutes in Additional Port group. Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group. There was no open conversion. Intra-operative (n = 5) and postoperative bile leakages (n = 2) were identified in six patients. Timing of operation after onset of symptoms was significantly greater in the group with bile duct injury than in those without bile duct injury in patients who required additional ports. Conclusions The first additional port in the epigastric area during SILC for acute cholecystitis helps to complete the operation without open conversion. However, the procedure can be performed safely in selective patients with relatively short duration of symptoms.",2020,Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group.,"['43 patients and two additional ports were inserted in 9 patients', '113 patients who underwent SILC for acute cholecystitis']","['incision laparoscopic cholecystectomy (SILC', 'Single-Incision Laparoscopic Cholecystectomy']","['safety and effectiveness', 'Mean operation time', 'postoperative bile leakages', 'Mean hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",2.0,0.0261793,Mean hospital stay was 3.7 days in the Pure SILC group and 5.9 days in Additional Port group.,"[{'ForeName': 'Ju-Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, College of Medicine, Hanyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gangmi', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Dongguk University Medical Center, Gyeongju, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00024'] 2406,32518499,Risk factors for mortality among Tanzanian infants and children.,"Background During the era of the Millennium Development Goals, under 5 mortality rates decreased significantly worldwide; however, reductions were not equally distributed. Children in sub-Saharan Africa still account for more than 50% of the world's annual childhood deaths among children under 5 years of age. Understanding upstream risk factors for mortality among children may reduce the large burden of childhood mortality in sub-Saharan Africa. Our objective was to identify risk factors for mortality among infants and children in Tanzania. Methods We conducted a secondary analysis of data pooled from two randomized-controlled micronutrient supplementation trials. A total of 4787 infants were enrolled in the two trials ( n = 2387 HIV-exposed and n = 2400 HIV-unexposed). Predictors of mortality were assessed using unadjusted and adjusted hazard ratios (aHRs). Results There were 307 total deaths, 262 (11%) among children who were HIV-exposed and 45 (2%) among children who were HIV-unexposed ( P < 0.001). The most common cause of death was respiratory diseases ( n = 109, 35.5%). Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children. In adjusted regression analyses, children with birth weight <2500 g (aHR 1.75, 95% CI 1.21-2.54), Apgar score of ≤7 at 5 min (aHR 2.16, 95% CI 1.29-3.62), or who were HIV-exposed but not infected (aHR 3.35, 95% CI 2.12-5.28) or HIV-infected (aHR 27.56, 95% CI 17.43-43.58) had greater risk of mortality. Conclusions Infection with HIV, low birthweight, or low Apgar scores were associated with higher mortality risk. Early identification and modification of determinants of mortality among infants and children may be the first step to reducing such deaths.",2020,Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children.,"['Tanzanian infants and children', 'infants and children', 'A total of 4787 infants were enrolled in the two trials ( n = 2387', 'infants and children in Tanzania']",[],"['Apgar score', 'risk of mortality', 'Causes of death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",4787.0,0.364443,Causes of death did not significantly differ between HIV-exposed and HIV-unexposed children.,"[{'ForeName': 'Rodrick R', 'Initials': 'RR', 'LastName': 'Kisenge', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rees', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA USA.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lauer', 'Affiliation': ""Clinical Research Centre, Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA USA.""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA USA.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard School of Public Health, Boston, MA USA.'}, {'ForeName': 'Karim P', 'Initials': 'KP', 'LastName': 'Manji', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.'}]",Tropical medicine and health,['10.1186/s41182-020-00233-8'] 2407,32518518,Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial.,"Background Intermittent claudication (IC) is a classic symptom of peripheral arterial disease, and strongly associated with coronary heart disease and cerebrovascular disease. Treatment of IC and secondary prevention of vascular events include best medical treatment (BMT), changes in lifestyle, most importantly smoking cessation and increased physical exercise, and in appropriate cases surgery. A person-centred and health promotion approach might facilitate breaking barriers to lifestyle changes and increasing adherence to secondary prevention therapy. The FASTIC study aims to evaluate a nurse-led, person-centred, health-promoting follow-up programme compared with standard follow-up by a vascular surgeon after surgical treatment for IC. Methods The FASTIC-study is a multicentre randomised controlled clinical trial. Patients will be recruited from two hospitals in Stockholm, Sweden after surgical treatment of IC through open and/or endovascular revascularisation and will be randomly assigned into two groups. The intervention group is offered a nurse-led, person-centred, health-promoting programme, which includes two telephone calls and three visits to a vascular nurse the first year after surgical treatment. The control group is offered standard care, which consists of a visit to a vascular surgeon 4-8 weeks after surgery and a visit to the outpatient clinic 1 year after surgical treatment. The primary outcome is adherence to BMT 1 year after surgical treatment and will be measured using The Swedish Prescribed Drug Registry. Clinical assessments, biomarkers, and questionnaires will be used to evaluate several secondary outcomes, such as predicted 10-year risk of cardiovascular and cerebrovascular events, health-related quality of life, and patients' perceptions of care quality. Discussion The FASTIC study will provide important information about interventions aimed at improving adherence to medication, which is an unexplored field among patients with IC. The study will also contribute to knowledge on how to implement person-centred care in a clinical context. Trial registration ClinicalTrials.govNCT03283358, registration date 06/13/2016.",2020,"The control group is offered standard care, which consists of a visit to a vascular surgeon 4-8 weeks after surgery and a visit to the outpatient clinic 1 year after surgical treatment.","['Patients will be recruited from two hospitals in Stockholm, Sweden after surgical treatment of IC through open and/or endovascular revascularisation', 'patients with IC']","['nurse-led, person-centred, health-promoting programme, which includes two telephone calls and three visits to a vascular nurse the first year after surgical treatment', '\n\n\nIntermittent claudication (IC']","[""10-year risk of cardiovascular and cerebrovascular events, health-related quality of life, and patients' perceptions of care quality"", 'adherence to BMT 1\u2009year after surgical treatment and will be measured using The Swedish Prescribed Drug Registry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]",,0.15236,"The control group is offered standard care, which consists of a visit to a vascular surgeon 4-8 weeks after surgery and a visit to the outpatient clinic 1 year after surgical treatment.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Haile', 'Affiliation': 'Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, and Department of Surgery, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Linné', 'Affiliation': 'Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, and Department of Surgery, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Unn-Britt', 'Initials': 'UB', 'LastName': 'Johansson', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Joelsson-Alm', 'Affiliation': 'Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, and Department of Anaesthesiology and Intensive Care, Södersjukhuset, Stockholm, Sweden.'}]",BMC nursing,['10.1186/s12912-020-00437-7'] 2408,32518558,Combination Therapy with 1% Nanocurcumin Gel and 0.1% Triamcinolone Acetonide Mouth Rinse for Oral Lichen Planus: A Randomized Double-Blind Placebo Controlled Clinical Trial.,"Objectives This study aimed to evaluate the efficacy of a combination of 1% nanocurcumin gel with 0.1% triamcinolone acetonide mouth rinse for oral lichen planus (OLP). Materials and Methods This double-blind randomized clinical trial was conducted on 31 patients with erosive or ulcerative OLP. All patients received 0.1% triamcinolone mouth rinse and were then randomly divided into two groups for combination therapy with (I) %1 nanocurcumin gel or (II) placebo gel. The reticular-erosive-ulcerative (REU) score was calculated at baseline and at two and four weeks after the intervention. The changes in the mean REU score and the efficacy index were calculated to determine the level of improvement after two and four weeks. Data were analyzed using independent t -test, repeated measures ANCOVA, Mann-Whitney test, and chi-square test. P < 0.05 was considered statistically significant. Results There were 14 patients in the nanocurcumin and 17 patients in the placebo group. A significantly higher decrease in the mean REU score was observed in the nanocurcumin compared with the placebo group ( P < 0.001). The efficacy index was significantly higher in the nanocurcumin group ( P < 0.001). Conclusion Application of 1% nanocurcumin in combination with 0.1% triamcinolone acetonide can serve as an effective treatment strategy to enhance the level of improvement of lesions compared with the use of triamcinolone acetonide alone.",2020,A significantly higher decrease in the mean REU score was observed in the nanocurcumin compared with the placebo group ( P < 0.001).,"['14 patients in the nanocurcumin and 17 patients in the placebo group', 'Oral Lichen Planus', '31 patients with erosive or ulcerative OLP']","['Placebo', 'Nanocurcumin Gel and 0.1% Triamcinolone Acetonide Mouth Rinse', 'combination therapy with (I) %1 nanocurcumin gel or (II) placebo gel', 'triamcinolone mouth rinse', 'triamcinolone acetonide', 'nanocurcumin gel with 0.1% triamcinolone acetonide mouth rinse', 'placebo']","['mean REU score and the efficacy index', 'efficacy index', 'mean REU score', 'reticular-erosive-ulcerative (REU) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",31.0,0.328247,A significantly higher decrease in the mean REU score was observed in the nanocurcumin compared with the placebo group ( P < 0.001).,"[{'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Gholami', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mahboubi', 'Affiliation': 'Food Safety Research Center, Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Jaafari', 'Affiliation': 'Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Namdari', 'Affiliation': 'Department of Community Oral Health, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Dermatology research and practice,['10.1155/2020/4298193'] 2409,32518560,"The Quality of Recovery after Dexamethasone, Ondansetron, or Placebo Administration in Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal Morphine. A Randomized Controlled Trial.","Intrathecal morphine is widely and successfully used to prevent postoperative pain after orthopedic surgery, but it is frequently associated with side effects. The aim of this study was to evaluate the effect of dexamethasone or ondansetron when compared to placebo to reduce the occurrence of these undesirable effects and, consequently, to improve the quality of recovery based on patient's perspective. Methods . One hundred and thirty-five patients undergoing lower extremity orthopedic surgery under spinal anesthesia using bupivacaine and morphine were randomly assigned to receive IV dexamethasone, ondansetron, or saline. On the morning following surgery, a quality of recovery questionnaire (QoR-40) was completed. Results . No differences were detected in the global and dimensional QoR-40 scores following surgery; however, following postanesthesia care unit (PACU) discharge, pain scores were higher in patients receiving ondansetron compared with patients who received dexamethasone. Conclusion . Neither ondansetron nor dexamethasone improves the quality of recovery after lower limbs orthopedic surgery under spinal anesthesia using intrathecal morphine.",2020,Neither ondansetron nor dexamethasone improves the quality of recovery after lower limbs orthopedic surgery under spinal anesthesia using intrathecal morphine.,"['One hundred and thirty-five patients undergoing lower extremity orthopedic surgery under spinal anesthesia using', 'Patients Undergoing Lower Limbs Orthopedic Surgery under Spinal Anesthesia Using Intrathecal', 'after lower limbs orthopedic surgery under spinal anesthesia using intrathecal']","['Dexamethasone, Ondansetron', 'Placebo', 'dexamethasone', 'morphine', 'Intrathecal morphine', 'IV dexamethasone, ondansetron, or saline', 'ondansetron', 'bupivacaine and morphine', 'Morphine', 'placebo']","['postoperative pain', 'quality of recovery questionnaire (QoR-40', 'global and dimensional QoR-40 scores', 'postanesthesia care unit (PACU) discharge, pain scores', 'quality of recovery']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",135.0,0.707056,Neither ondansetron nor dexamethasone improves the quality of recovery after lower limbs orthopedic surgery under spinal anesthesia using intrathecal morphine.,"[{'ForeName': 'Eduardo Toshiyuki', 'Initials': 'ET', 'LastName': 'Moro', 'Affiliation': 'Department of Surgery, School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, Sorocaba, São Paulo, Brazil.'}, {'ForeName': 'Miguel Antônio Teixeira', 'Initials': 'MAT', 'LastName': 'Ferreira', 'Affiliation': 'Department of Surgery, School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, Sorocaba, São Paulo, Brazil.'}, {'ForeName': 'Renyer Dos Santos', 'Initials': 'RDS', 'LastName': 'Gonçalves', 'Affiliation': 'Department of Surgery, School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, Sorocaba, São Paulo, Brazil.'}, {'ForeName': 'Roberta Costa', 'Initials': 'RC', 'LastName': 'Vargas', 'Affiliation': 'School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Samira Joverno', 'Initials': 'SJ', 'LastName': 'Calil', 'Affiliation': 'School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Alice', 'Initials': 'MA', 'LastName': 'Soranz', 'Affiliation': 'School of Medical and Health Sciences, Pontifical Catholic University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bloomstone', 'Affiliation': 'University of Arizona College of Medicine-Phoenix, Phoenix, AZ, USA.'}]",Anesthesiology research and practice,['10.1155/2020/9265698'] 2410,32518572,The Effects of a Peer-Counseling Program on Increase Rate and Continuity of Lactation in Tehran Nursing Mothers.,"Objective: The practice of breastfeeding is considered a blessing since its effects on health are well recognized and applies to both mothers and infants. The objective of this study was to evaluate the effectiveness of peer support and training on breastfeeding initiation, duration and exclusivity. Materials and methods: This community-based clinical trial, (IRCT No: 201504049568N12), was conducted during 2015 in the Municipality of Tehran 19 District. First, a total of 150 mothers with their infants from 4 to 20 months of age were asked to complete a questionnaire, which included the demographic characteristics, educational level, and the type of lactation, the initial age of infant for breastfeeding, and the duration of exclusive breastfeeding. Afterwards, 25 volunteer women were selected for lactation counseling. After 6 months, another sample of 116 nursing mothers in the region who had received peer counseling was selected and questioned through the previously mentioned questionnaire. Finally, the results, which were collected from the behavior of the target population before and after the intervention, were compared. Results: The results of the present study indicated that the nursing mothers who received peer counseling proved to have longer durations of breastfeeding (P-value = 0.039), and higher frequency of first hour initiation of breastfeeding (P-value = 0.003) however, the volunteer counselors were mainly housewives who had lower levels of education (P-value = 0.009) and were younger (P-value = 0.009) than those of untrained control group. Conclusion: The study demonstrated the significant effect of peer counseling on breastfeeding initiation and continuation. It is suggested that lactation training could be initiated during the prenatal period along with the conventional methods of training.",2019,"The results of the present study indicated that the nursing mothers who received peer counseling proved to have longer durations of breastfeeding (P-value = 0.039), and higher frequency of first hour initiation of breastfeeding (P-value = 0.003) however, the volunteer counselors were mainly housewives who had lower levels of education (P-value = 0.009) and were younger (P-value = 0.009) than those of untrained control group. ","['150 mothers with their infants from 4 to 20 months of age were asked to complete a questionnaire, which included the demographic characteristics, educational level, and the type of lactation, the initial age of infant for breastfeeding, and the duration of exclusive breastfeeding', 'Tehran Nursing Mothers', '116 nursing mothers in the region who had received', '25 volunteer women were selected for lactation counseling', ' 201504049568N12), was conducted during 2015 in the Municipality of Tehran 19 District']","['IRCT', 'peer counseling', 'peer support and training', 'Peer-Counseling Program']","['breastfeeding initiation, duration and exclusivity', 'Increase Rate and Continuity of Lactation', 'longer durations of breastfeeding', 'higher frequency of first hour initiation of breastfeeding']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",150.0,0.0313768,"The results of the present study indicated that the nursing mothers who received peer counseling proved to have longer durations of breastfeeding (P-value = 0.039), and higher frequency of first hour initiation of breastfeeding (P-value = 0.003) however, the volunteer counselors were mainly housewives who had lower levels of education (P-value = 0.009) and were younger (P-value = 0.009) than those of untrained control group. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nayeri', 'Affiliation': 'Breastfeeding Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Farrokhzad', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Esmaeilnia', 'Affiliation': 'Breastfeeding Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nikoo', 'Initials': 'N', 'LastName': 'Niknafs', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Dalili', 'Affiliation': 'Breastfeeding Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Atarod', 'Affiliation': 'Department of Pediatrics, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hasti', 'Initials': 'H', 'LastName': 'Charousaei', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mamak', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Institute of Family Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of family & reproductive health,[] 2411,32518587,Positive intervention for depression and teacher-student relationship in Iranian high school girl students with moderate/mild depression: a pilot randomized controlled trial.,"Background Positive intervention (PI) is a modern and therapeutic approach broadly based on the principles of positive psychology (Rashid in J Posit Psychol 1:25-40, 2014). PI effects at schools have received little attention to date. However, since PI offers a focus on the positive aspects of human experience (Seligman and Csikszentmihalyi in Am Psychol 55:5-14, 2000), we hypothesized that it could exert positive changes in the teacher-student relationship (TSR) and depression symptoms. Therefore, the mentioned pilot study conducted in this article aimed at evaluating PI effects on depression and TSR among Iranian high school girl students with moderate/mild depression. Method In this research, 60 eligible female students (aged 15-18) with a Beck Depression Inventory-II (BDI-II) mild-moderate depression diagnosis, were randomly divided into PI ( n  = 30) and control groups ( n  = 30) at the time of entering the study and 2 months later following their assessments through the Inventory of TSR (IT-SR) and BDI-II. The intervention group participated in 8-week 2 h group sessions of PI and the control group was evaluated without any intervention. Results The study was completed with a total number of 49 girls [PI group ( n  = 24), and control group ( n  = 25)] and everybody participate in 8 sessions. The intervention group was effective on the variables of BDI-II and IT-SR in a way that the involved girls increased their communication ( p  = 0.001, d  = 0.17), trust ( p  = 0.001 d  = 0.14) after PI training and decreased alienation ( p  = 0.012, d  = 0.11) and depression ( p  = 0.001, d  = 0.15) among other high school students. Conclusion This intervention could function as an unspecific component of a stepped care approach for teenage girls suffering from depression. This study recommends more RCT with large sample sizes among high school boys students and follow-up.",2020,"p  = 0.001 d  = 0.14) after PI training and decreased alienation ( p  = 0.012, d  = 0.11) and depression ( p  = 0.001, d  = 0.15) among other high school students. ","['60 eligible female students (aged 15-18) with a Beck Depression Inventory-II (BDI-II) mild-moderate depression diagnosis', 'Iranian high school girl students with moderate/mild depression', 'teenage girls suffering from depression', '49 girls [PI group ( n\u2009 =\u200924), and control group ( n\u2009 =\u200925)] and everybody participate in 8 sessions']","['\n\n\nPositive intervention (PI', 'Positive intervention']","['BDI-II and IT-SR', 'depression', 'alienation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0588006', 'cui_str': 'Mild depression'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0309167,"p  = 0.001 d  = 0.14) after PI training and decreased alienation ( p  = 0.012, d  = 0.11) and depression ( p  = 0.001, d  = 0.15) among other high school students. ","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghvaienia', 'Affiliation': 'Department of Education and Psychology, Faculty of Humanities, Yasouj University, Yasouj, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Zonobitabar', 'Affiliation': 'Department of Education and Psychology, Faculty of Humanities, Yasouj University, Yasouj, Iran.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-020-00331-9'] 2412,32518655,Effect of high-intensity interval training in young heart transplant recipients: results from two randomized controlled trials.,"Background Little is known about the effect of exercise in young heart transplant recipients, and results on group level is lacking. This study summarizes the findings of the youngest participants in two previous randomized controlled trials. Method This is a hypothesis-generating study reporting the main results from the youngest participants in two larger randomized controlled trials investigating the effect of high-intensity interval training (HIT). The article summarizes the main results from 28 young participants (< 40 year of age) who have participated in two previous studies which evaluated the effect of HIT vs. controls in adult heart transplant recipients. One of the studies included de novo heart transplant recipients and the other included maintenance heart transplant recipients.All study tests were performed in-hospital, in the specialist health care setting, but the exercise intervention was carried out locally, in cooperation with the primary health care. In both studies the exercise intervention lasted for 9-12 months. In one study, HIT (85-95% of peak effort) was compared to controls (no specific intervention), and in the other study HIT was compared to moderate, continuous exercise (MICT , 60-80% of peak effort). The main outcome measure was peak oxygen uptake (VO 2peak ) and a secondary endpoint was muscle strength. Results The summarized findings from the youngest heart transplant recipients in these two studies demonstrated mainly that the improvement in peak oxygen uptake among the younger recipients (< 40 years) was much larger (4.7 vs. 1.2 ml/kg/min and 7.0 vs. 2.2 ml/kg/min) compared to the improvement among the older recipients (≥ 40 years), and in accordance with results from adult heart transplant populations: HIT, compared to MICT, induced the largest improvement in peak oxygen consumption, also in the younger heart transplant recipients. Conclusions These results suggest that young heart transplant recipients have a greater effect of HIT than of MICT and may also suggest that younger recipients benefit more from high-intensity interval training than their older co-patients. However, larger randomized studies focusing on the young heart transplant population is strongly needed to confirm this hypothesis. Trial registration Clinical trial registrations: NCT01796379 and NCT01091194.",2020,"In one study, HIT (85-95% of peak effort) was compared to controls (no specific intervention), and in the other study HIT was compared to moderate, continuous exercise (MICT , 60-80% of peak effort).","['28 young participants (<\u200940\u2009year of age) who have participated in two previous studies which evaluated the effect of HIT vs. controls in adult heart transplant recipients', 'young heart transplant population', 'young heart transplant recipients']","['exercise intervention', 'high-intensity interval training', 'high-intensity interval training (HIT', 'MICT']","['peak oxygen uptake (VO 2peak ) and a secondary endpoint was muscle strength', 'peak oxygen uptake', 'peak oxygen consumption']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",28.0,0.0469679,"In one study, HIT (85-95% of peak effort) was compared to controls (no specific intervention), and in the other study HIT was compared to moderate, continuous exercise (MICT , 60-80% of peak effort).","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, postbox 4950, Nydalen, 0424 Oslo, Norway.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, postbox 4950, Nydalen, 0424 Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, postbox 4950, Nydalen, 0424 Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, postbox 4950, Nydalen, 0424 Oslo, Norway.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00180-1'] 2413,32518663,Asthma management with breath-triggered inhalers: innovation through design.,"Background Asthma affects the lives of hundred million people around the World. Despite notable progresses in disease management, asthma control remains largely insufficient worldwide, influencing patients' wellbeing and quality of life. Poor patient handling of inhaling devices has been identified as a major persistent problem that significantly reduces inhaled drugs' efficacy and is associated with poor adherence to treatment, impairing clinical results such as asthma control and increasing disease-related costs. We herein review key research and development (R&D) innovation in inhaler devices, highlighting major real-world critical errors in the handling and inhalation technique with current devices and considering potential solutions. Furthermore, we discuss current evidence regarding breath-triggered inhalers (BTI). Main body The two most common significant problems with inhalers are coordinating actuation and inhalation with pressurized metered-dose inhalers (pMDIs), and the need to inhale forcibly with a dry powder inhaler. BTI R&D plans were designed to overcome these problems. Its newest device k-haler® has several other important features, generating a less forceful aerosol plume than previous pMDIs, with efficient drug delivery and lung deposition, even in patients with low inspiratory flow. The local and systemic bioavailability of fluticasone propionate and formoterol (FP/FORM) administered via k-haler® has been shown to be therapeutically equivalent when administered via the previous FP/FORM pMDI. This device requires very few steps and has been considered easy to use (even at first attempt) and preferred by the patients in a randomized crossover study. In our country, FP/FORM k-haler is available without additional costs compared to FP/FORM pMDI. All devices continue to require education and regular checking of the correct inhalation technique. Conclusion BTI R&D can bring advantage over current available inhalers, avoiding the two most common identified critical errors in inhalation technique. K-haler® BTI is currently available, without an increased cost, and approved for adolescents and adults with asthma in whom treatment with inhaled combined therapy with long-acting beta 2 -agonists and corticosteroids is indicated. Its attractive and practical design to facilitate its use has been awarded. K-haler® represents added value through innovation to fulfill actual asthma patient needs, thus with potential relevant impact in asthma management and effective control.",2020,The local and systemic bioavailability of fluticasone propionate and formoterol (FP/FORM) administered via k-haler® has been shown to be therapeutically equivalent when administered via the previous FP/FORM pMDI.,"['adolescents and adults with asthma in whom treatment with inhaled combined therapy with long-acting beta 2 -agonists and corticosteroids', 'patients with low inspiratory flow']",['fluticasone propionate and formoterol (FP/FORM'],['local and systemic bioavailability'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0416382,The local and systemic bioavailability of fluticasone propionate and formoterol (FP/FORM) administered via k-haler® has been shown to be therapeutically equivalent when administered via the previous FP/FORM pMDI.,"[{'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Morais-Almeida', 'Affiliation': 'Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pité', 'Affiliation': 'Allergy Center, CUF Descobertas Hospital and CUF Infante Santo Hospital, Lisbon, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Cardoso', 'Affiliation': 'Pulmonology Department, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Family Medicine, Porto, Portugal.'}, {'ForeName': 'Carlos Robalo', 'Initials': 'CR', 'LastName': 'Cordeiro', 'Affiliation': 'Pulmonology Department, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Eurico', 'Initials': 'E', 'LastName': 'Silva', 'Affiliation': 'Family Medicine USF João Semana, Aveiro, Ovar, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Todo-Bom', 'Affiliation': 'Immunoallergology Department, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Vicente', 'Affiliation': 'Family Medicine UCSP Soure, Coimbra, Portugal.'}, {'ForeName': 'José Agostinho', 'Initials': 'JA', 'LastName': 'Marques', 'Affiliation': 'Pulmonology Department, Centro Hospitalar de São João, Porto, Portugal.'}]",Asthma research and practice,['10.1186/s40733-020-00057-7'] 2414,32518670,A pilot open-label feasibility trial examining an adjunctive mindfulness intervention for adolescents with obesity.,"Background Obesity in adolescence is predictive of obesity in adulthood and risk for chronic disease. Traditional behavioral approaches to addressing obesity in adolescence rarely yield meaningful changes in body mass index (BMI), suggesting that adjunctive treatments are necessary. Herein, we describe a study examining whether it is feasible to integrate a brief mindfulness intervention with the usual recommended care for adolescent obesity in a pediatric weight management clinic. Methods We conducted a single arm open-label trial with 11 adolescent patients with obesity. Participants received the recommended standard of medical management of obesity (usual care) plus a six-week mindfulness intervention. To assess our primary aim of feasibility, we examined recruitment, retention, and satisfaction rates. Participants also completed measures of mindfulness, emotion regulation, disordered eating, quality of life, and executive functioning, and had their BMI and blood pressure measured. Results We recruited 11 adolescents to participate in the intervention, with 8 (73%) completing the entire program. Attendance rates (85%) and satisfaction rates (100%) were promising for a larger trial. While preliminary analyses of changes in health outcomes should be examined with caution, effect sizes ranged from small to large with some promising trends in eating behaviors. Discussion It might be feasible to augment existing behavioral interventions for adolescents with obesity with brief mindfulness; however, some adaptations are needed to enhance recruitment and retention. The lessons learned in this feasibility study can inform an adequately powered efficacy trial. Trial registration This research is registered on ClinicalTrials.gov (NCT03874377).",2020,Attendance rates (85%) and satisfaction rates (100%) were promising for a larger trial.,"['11 adolescents to participate in the intervention, with 8 (73%) completing the entire program', 'adolescents with obesity', '11 adolescent patients with obesity', 'adolescents with obesity with brief mindfulness']","['standard of medical management of obesity (usual care) plus a six-week mindfulness intervention', 'adjunctive mindfulness intervention']","['Attendance rates', 'satisfaction rates', 'retention, and satisfaction rates', 'mindfulness, emotion regulation, disordered eating, quality of life, and executive functioning, and had their BMI and blood pressure measured']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",11.0,0.0547532,Attendance rates (85%) and satisfaction rates (100%) were promising for a larger trial.,"[{'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Cotter', 'Affiliation': 'Department of Health Studies, American University, 4400 Massachusetts Ave NW, Washington DC, 20016 USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hornack', 'Affiliation': ""Division of Psychology and Behavioral Health, Children's National Health System, 111 Michigan Avenue NW, Washington DC, 20010 USA.""}, {'ForeName': 'Jenny P', 'Initials': 'JP', 'LastName': 'Fotang', 'Affiliation': 'Department of Psychology, American University, 4400 Massachusetts Ave NW, Washington DC, 20016 USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pettit', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, 2300 Eye Street, NW, Washington DC, 20037 USA.'}, {'ForeName': 'Nazrat M', 'Initials': 'NM', 'LastName': 'Mirza', 'Affiliation': ""IDEAL Pediatric Weight Management Clinic, Children's National Health System, 111 Michigan Avenue NW, Washington DC, 20010 USA.""}]",Pilot and feasibility studies,['10.1186/s40814-020-00621-1'] 2415,32518673,"Does dog acquisition improve physical activity, sedentary behaviour and biological markers of cardiometabolic health? Results from a three-arm controlled study.","Objectives Dog ownership has been associated with improved cardiometabolic risk factors, including physical activity. Most of the evidence originates from cross-sectional studies or populations with established disease. This study investigated changes in physical activity and other cardiometabolic risk factors following dog acquisition in a sample of 71 community-dwelling adults. Methods Participants self-allocated to three groups: 17 individuals acquired a dog within 1 month of baseline (dog acquisition), 29 delayed dog acquisition until study completion (lagged control) and 25 had no interest in dog acquisition (community control). Self-reported and thigh-worn accelerometer-based physical activity patterns, systolic and diastolic blood pressures, resting heart rate and VO 2 max were measured three times: baseline, 3 months and 8 months. Data were analysed using repeated measures analysis of covariance with owner age, season, sex and education included as covariates. Post hoc between-group tests were performed where there were significant overall effects (p<0.05). Results We found significant effects in mean daily steps (F (4,64)=3.02, p=0.02) and sit-to-stand transitions ( F (4,66)=3.49, p=0.01). The dog acquisition group performed an additional 2589 steps (p=0.004) and 8.2 sit-to-stand transitions (p=0.03) per day at 3 months, although these effects were not maintained at 8 months. We found a significant effect in self-reported weekly walking duration ( F (4,130)=2.84, p=0.03) among the lagged control group with an 80 min increase between 3 and 8 months (p=0.04). Other cardiometabolic risk factors were unchanged following dog acquisition. Conclusion Our study provides encouraging results that suggest a positive influence of dog acquisition on physical activity in the short term but larger and more generalisable controlled studies are needed. Trial registration number ACTRN12617000967381.",2020,"We found significant effects in mean daily steps (F (4,64)=3.02, p=0.02) and sit-to-stand transitions ( F (4,66)=3.49, p=0.01).","['dog acquisition in a sample of 71 community-dwelling adults', 'Participants self-allocated to three groups: 17 individuals acquired a dog within 1\u2009month of baseline (dog acquisition), 29 delayed dog acquisition until study completion (lagged control) and 25 had no interest in dog acquisition (community control']",[],"['physical activity, sedentary behaviour and biological markers of cardiometabolic health', 'cardiometabolic risk factors', 'Self-reported and thigh-worn accelerometer-based physical activity patterns, systolic and diastolic blood pressures, resting heart rate and VO', 'physical activity']","[{'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",2.0,0.0524948,"We found significant effects in mean daily steps (F (4,64)=3.02, p=0.02) and sit-to-stand transitions ( F (4,66)=3.49, p=0.01).","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Powell', 'Affiliation': 'Charles Perkins Centre, Prevention Research Collaboration, Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Charles Perkins Centre, Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Charles Perkins Centre, Prevention Research Collaboration, Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McGreevy', 'Affiliation': 'Sydney School of Veterinary Science, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Podberscek', 'Affiliation': 'Charles Perkins Centre, Sydney School of Veterinary Science, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Neilly', 'Affiliation': 'Royal Society for the Prevention of Cruelty to Animals (RSPCA), Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Charles Perkins Centre, Prevention Research Collaboration, Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2019-000703'] 2416,32518674,Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised clinical trial.,"Study design Pilot, multicentre randomised clinical trial (RCT). Objectives Assess viability of performing a definitive RCT and compare preliminary effects of movement pattern training (MoveTrain) and strengthening/flexibility (Standard) to improve function in people with chronic hip-related groin pain (HRGP). Background To determine the best physical therapist-led intervention for patients with HRGP, we must understand treatment effects of different treatment modes. Methods Forty-six patients (17M:29F; 29±5.3 years; body mass index 25.6±6.3 kg/m 2 ) with HRGP were randomised. MoveTrain included task-specific training to optimise biomechanics during daily tasks. Standard included strengthening/flexibility. Treatment included 10 visits/12 weeks and home exercise programme (HEP). Primary outcomes for feasibility were recruitment, retention, treatment adherence and treatment fidelity. Secondary outcomes were patient-reported function (Hip disability and Osteoarthritis Outcome Score (HOOS)), lower extremity kinematics and hip muscle strength. Results We achieved target recruitment, and retention was excellent (91%). Patient session attendance was high (93%); however, reported HEP adherence (62%) was lower than expected. Physical therapists' adherence to treatment protocols was high (90%). Patients demonstrated high treatment receipt; 91% of exercises performed were rated independent. Both groups demonstrated clinically important improvements in function (HOOS) and muscle strength; however, there were no between-group differences (HOOS subscales, p≥0.13, strength, p≥0.34). Compared with Standard, MoveTrain demonstrated greater reductions in hip adduction (p=0.016) and pelvic drop (p=0.026) during a single leg squat. No adverse events were noted. Conclusion Our experience in completing this RCT confirmed that a larger, multicentre RCT is feasible and highlighted modifications we will implement to optimise the future RCT. Trial registration number NCT02913222.",2020,"Compared with Standard, MoveTrain demonstrated greater reductions in hip adduction (p=0.016) and pelvic drop (p=0.026) during a single leg squat.","['Methods\n\n\nForty-six patients (17M:29F; 29±5.3 years; body mass index 25.6±6.3\u2009kg/m 2 ) with HRGP were randomised', 'patients with hip-related groin pain', 'patients with HRGP', 'people with chronic hip-related groin pain (HRGP']","['movement pattern training (MoveTrain) and strengthening/flexibility (Standard', 'Movement pattern training', 'standard strengthening and flexibility', 'home exercise programme (HEP']","['hip adduction', 'HEP adherence', 'Patient session attendance', 'function (HOOS) and muscle strength', 'feasibility were recruitment, retention, treatment adherence and treatment fidelity', 'patient-reported function (Hip disability and Osteoarthritis Outcome Score (HOOS)), lower extremity kinematics and hip muscle strength', 'adverse events']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]","[{'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.163156,"Compared with Standard, MoveTrain demonstrated greater reductions in hip adduction (p=0.016) and pelvic drop (p=0.026) during a single leg squat.","[{'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Harris-Hayes', 'Affiliation': 'Department of Physical Therapy, Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steger-May', 'Affiliation': 'Division of Biostatistics, Washington University in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Allyn M', 'Initials': 'AM', 'LastName': 'Bove', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stefanie N', 'Initials': 'SN', 'LastName': 'Foster', 'Affiliation': 'Department of Physical Therapy, Washington University in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mueller', 'Affiliation': 'Department of Physical Therapy, Washington University in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Clohisy', 'Affiliation': 'Department of Orthopaedic Surgery, Washington University in Saint Louis, Saint Louis, Missouri, USA.'}, {'ForeName': 'G Kelley', 'Initials': 'GK', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",BMJ open sport & exercise medicine,['10.1136/bmjsem-2019-000707'] 2417,32518682,Effect of ferric-carboxy maltose on oxygen kinetics and functional status in heart failure patients with iron deficiency.,"There is a very high prevalence of iron deficiency anemia in patients with systolic heart failure. The present study is a prospective, parallel, 1:1 randomized controlled trial of intravenous ferric-carboxy maltose compared with standard of care in patients with heart failure. A total of 70 patients who presented to us with symptomatic chronic heart failure were included and randomly assigned to either groups (35 per group). Post 12 weeks, there were improvements noticed in peak VO 2 , New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score in the ferric-carboxy maltose as compared with standard of care group. However, no improvement in ejection fraction was noticed.",2020,"Post 12 weeks, there were improvements noticed in peak VO 2 , New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score in the ferric-carboxy maltose as compared with standard of care group.","['70 patients who presented to us with symptomatic chronic heart failure', 'patients with systolic heart failure', 'patients with heart failure', 'heart failure patients with iron deficiency']","['ferric-carboxy maltose', 'intravenous ferric-carboxy maltose']","['oxygen kinetics and functional status', 'ejection fraction', 'peak VO 2 , New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0024658', 'cui_str': 'Maltose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.0879056,"Post 12 weeks, there were improvements noticed in peak VO 2 , New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score in the ferric-carboxy maltose as compared with standard of care group.","[{'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Dhoot', 'Affiliation': 'Department of Cardiology, Dedanta, The Medicity Hospital, Gurgaon, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Dedanta, The Medicity Hospital, Gurgaon, India.'}, {'ForeName': 'Simar Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiology, Dedanta, The Medicity Hospital, Gurgaon, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Chelsea & Westminster Hospital NHS Foundation Trust, West Middlesex University Hospital Site, Isleworth, UK.'}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Kasliwal', 'Affiliation': 'Department of Cardiology, Dedanta, The Medicity Hospital, Gurgaon, India.'}, {'ForeName': 'Varshil', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'Chelsea & Westminster Hospital NHS Foundation Trust, West Middlesex University Hospital Site, Isleworth, UK.'}]",Future science OA,['10.2144/fsoa-2019-0156'] 2418,32518696,"Comment on ""Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial"".",,2020,,['Chronic Obstructive Pulmonary Disease'],['Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique'],[],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],,0.0301672,,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bordoni', 'Affiliation': 'Foundation Don Carlo Gnocchi IRCCS, Department of Cardiology, Institute of Hospitalization and Care with Scientific, Via Capecelatro 66, Milan 20100, Italy.'}]",Pulmonary medicine,['10.1155/2020/7437019'] 2419,32518704,Virtual Nature as an Intervention for Reducing Stress and Improving Mood in People with Substance Use Disorder.,"Substance use disorder (SUD) afflicts a large percentage of the United States population, with negative implications that cost more than $420 billion annually. This population often experiences negative emotions throughout the recovery process, including anxiety, depression, stress, and negative affect. Currently, evidence-based treatment strategies for SUD include cognitive behavioral therapy, motivational interviewing, 12-step programs, and mindfulness-based treatment. One intervention that has not been studied at length among individuals with SUD is use of the natural environment as treatment. Among other patient populations, nature has been shown to reduce stress and anxiety by regulating autonomic nervous system function, reducing symptoms of depression, and improving mood. The purpose of this study was to investigate whether viewing nature videos could similarly reduce stress and improve mood in individuals with SUD. A crossover design was used to compare viewing a nature scene and practicing mindfulness-based activities for women with SUD at a residential treatment facility. Over four weeks, participants engaged in the two activities for the first 10 minutes of their daily program. Immediately before and after each 10 minute session, measures were taken for heart rate, in beats per minute (BPM); affect, using the Positive and Negative Affect Scale (PANAS); and overall mood, using a 10-point rating scale from ""very unpleasant"" to ""pleasant."" Thirty-six women completed the study. For viewing a nature scene and practicing the mindfulness-based activities, there were statistically significant reductions in mean negative affect scores ( p =0.001) and heart rate ( p ≤ 0.001). In addition, for participants in both conditions, overall mood improved significantly ( p =0.030). The results from this study provide initial evidence that viewing nature has similar benefits to MBT in the treatment of stress and negative mood associated with the SUD recovery process and may be an additional, cost-effective treatment strategy for individuals with SUD.",2020,"For viewing a nature scene and practicing the mindfulness-based activities, there were statistically significant reductions in mean negative affect scores ( p =0.001) and heart rate ( p ≤ 0.001).","['People with Substance Use Disorder', 'individuals with SUD', 'Thirty-six women completed the study', 'women with SUD at a residential treatment facility']","['viewing nature videos', 'MBT']","['overall mood', 'mean negative affect scores', 'heart rate, in beats per minute (BPM); affect, using the Positive and Negative Affect Scale (PANAS); and overall mood, using a 10-point rating scale from ""very unpleasant"" to ""pleasant', 'heart rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}]",,0.0370421,"For viewing a nature scene and practicing the mindfulness-based activities, there were statistically significant reductions in mean negative affect scores ( p =0.001) and heart rate ( p ≤ 0.001).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Reynolds', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Oaklee', 'Initials': 'O', 'LastName': 'Rogers', 'Affiliation': 'Faculty Lead for the Community Health Mentor Program (CHMP), 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Benford', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Ammie', 'Initials': 'A', 'LastName': 'Ingwaldson', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Vu', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Holstege', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Korinna', 'Initials': 'K', 'LastName': 'Alvarado', 'Affiliation': 'Department of Occupational Therapy, Northern Arizona University, 435 N 5th Street, Phoenix, AZ 85004, USA.'}]",Journal of addiction,['10.1155/2020/1892390'] 2420,32518777,Ligliptin for treatment of type 2 diabetes mellitus with early renal injury: Efficacy and impact on endogenous hydrogen sulfide and endothelial function.,"BACKGROUND Diabetes is a clinically common chronic disease, and its incidence has been increasing in recent years. Diabetes is believed to accelerate the process of atherosclerosis in patients, and abnormal endothelial function is an important factor leading to diabetic kidney damage. AIM To investigate the efficacy of ligliptin in the treatment of type 2 diabetes mellitus (T2DM) with early renal injury and its effect on serum endogenous hydrogen sulfide (H 2 S), endothelial cell particles, and endothelial function. METHODS From January 2018 to April 2019, 110 patients with T2DM and early kidney injury treated at our hospital were divided into an observation group (receiving ligliptin treatment, n = 54) and a control group (receiving gliquidone therapy, n = 56). Blood glucose and renal function before and after treatment were compared between the two groups. RESULTS The differences in fasting blood glucose, 2 h blood glucose, and glycated hemoglobin were not statistically significant between the two groups after treatment. The urinary albumin excretion rate after treatment in the ligliptin group was 70.32 ± 11.21 µg/min, which was significantly lower than that of the gliquidone group ( P = 0.000). Serum endogenous H 2 S and endothelial cell microparticles of the ligliptin treatment group were 40.04 ± 8.82 mol/L and 133.40 ± 34.39, respectively, which were significantly lower than those of the gliquidone treatment group ( P = 0.000 for both); endothelin-dependent diastolic function and nitric oxide after treatment in the ligliptin group were 7.98% ± 1.22% and 190.78 ± 30.32 mol/L, significantly higher than those of the gliquidone treatment group ( P = 0.000 for both). CONCLUSION Ligliptin treatment of T2DM with early renal injury has the same glucose-lowering effect as gliquidone treatment. Ligliptin treatment has a better effect and it can significantly improve the renal function and vascular endothelial function of patients, and reduce serum endogenous H 2 S and endothelial cell particle levels.",2020,"The differences in fasting blood glucose, 2 h blood glucose, and glycated hemoglobin were not statistically significant between the two groups after treatment.","['From January 2018 to April 2019, 110 patients with T2DM and early kidney injury treated at our hospital', 'type 2 diabetes mellitus (T2DM) with early renal injury', 'type 2 diabetes mellitus with early renal injury']","['ligliptin', 'Ligliptin', 'gliquidone', 'observation group (receiving ligliptin treatment, n = 54) and a control group (receiving gliquidone therapy']","['diastolic function and nitric oxide', 'renal function and vascular endothelial function', 'Serum endogenous H 2 S and endothelial cell microparticles', 'fasting blood glucose, 2 h blood glucose, and glycated hemoglobin', 'Blood glucose and renal function', 'serum endogenous hydrogen sulfide (H 2 S), endothelial cell particles, and endothelial function', 'urinary albumin excretion rate']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0061328', 'cui_str': 'gliquidone'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0020282', 'cui_str': 'Hydrogen sulfide'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}]",110.0,0.014449,"The differences in fasting blood glucose, 2 h blood glucose, and glycated hemoglobin were not statistically significant between the two groups after treatment.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, China.'}, {'ForeName': 'Yong-Li', 'Initials': 'YL', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, Tai'an Central Hospital, Tai'an 271000, Shandong Province, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Rheumatology, Tai'an Central Hospital, Tai'an 271000, Shandong Province, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Sui', 'Affiliation': ""Department of Geriatrics, Tai'an Central Hospital, Tai'an 271000, Shandong Province, China.""}, {'ForeName': 'Wei-Kai', 'Initials': 'WK', 'LastName': 'Hou', 'Affiliation': 'Department of Endocrinology, Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, China. pro.hwk@163.com.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i10.1878'] 2421,32518854,"Fecal microbiota transplantation for patients on antibiotic treatment with C. difficile infection history (GRAFT): Study protocol for a phase II, randomized, double-blind, placebo-controlled trial to prevent recurrent C. difficile infections.","Recurrent Clostridiodes difficile infections (rCDIs) are a burdensome problem. Patients with a history of CDI that are prescribed antibiotics are at a high risk for recurrence. Fecal microbiota transplantation (FMT) has been shown to be an effective treatment for rCDI, though there is little information on the impact of FMT with antibiotics on the gut microbiome. We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics. Our primary objective is to determine the effect of FMT on the gut microbiome during antibiotic exposure. Our secondary aim is to assess safety and feasibility of using FMT as a prophylaxis for CDI. We plan to enroll 30 patients into a phase II randomized, double-blind, placebo-controlled trial with three arms: (1) 5 FMT capsules per day during antibiotic treatment and for 7 days post antibiotic cessation, (2) a one-time dose of 30 FMT capsules 48-72 h post cessation of antibiotic treatment, or (3) 5 placebo capsules per day during antibiotic treatment and for 7 days post antibiotic treatment. Patients provide stool samples throughout the duration of the study and are cultured C. difficile. Sequencing of the V4 region of the 16S rRNA gene will be carried out to assess the gut microbiota. Results of this study will provide information on the impact of FMT on the gut microbiome as well as the necessary data to examine whether or not prophylactic FMT should be explored further as a way to prevent CDI recurrence.",2020,We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics.,"['patients with a history of CDI currently taking antibiotics', 'patients on antibiotic treatment with C. difficile infection history (GRAFT', 'recurrent C. difficile infections']","['FMT capsules per day during antibiotic treatment and for 7 days post antibiotic cessation, (2) a one-time dose of 30 FMT capsules 48-72\xa0h post cessation of antibiotic treatment, or (3) 5 placebo', 'FMT', 'Fecal microbiota transplantation (FMT', 'placebo']",['Fecal microbiota transplantation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}]",,0.33438,We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics.,"[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Kates', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Ilsa', 'Initials': 'I', 'LastName': 'Gaulke', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'De Wolfe', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Zimbric', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Haight', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Watson', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Garret', 'Initials': 'G', 'LastName': 'Suen', 'Affiliation': 'Department of Bacteriology, College of Agricultural and Life Sciences, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Kyungmann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics & Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Nasia', 'Initials': 'N', 'LastName': 'Safdar', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100576'] 2422,32518861,A Randomized Trial of Modified-Release Versus Immediate-Release Tolvaptan in ADPKD.,"Introduction Tolvaptan, for treatment of autosomal dominant polycystic kidney disease (ADPKD), is provided as immediate-release (IR) tablets administered twice daily in split-dose regimens to suppress urine osmolality to <300 mOsm/kg. A modified-release (MR) formulation was developed for once-daily (QD) dosing to increase compliance and mitigate urinary symptom burden. This phase 2, dose-ranging study (NCT01210560) compared pharmacokinetics, pharmacodynamics, and tolerability of several MR regimens with IR in patients with ADPKD. Methods This was a multicenter, parallel-arm, randomized, crossover, double-blind, placebo-controlled trial. Each of 2 study arms had 12 subjects and 3 crossover periods. Dose regimens were administered for 7 days; placebo-masked QD versus split-dose treatments. Endpoints included pharmacokinetic parameters, percentage of subjects with urine osmolality <300 mOsm/kg, urine volume, number of daily urine voids, and tolerability. Results Tolvaptan MR 20 to 120 mg exhibited dose-proportional pharmacokinetics. Percentage of subjects with spot urine osmolality <300 mOsm/kg increased with dose, with tolvaptan MR 120 mg and IR 90+30 mg each suppressing 91.7% of subjects below this level. Urinary burden on the ADPKD Nocturia Quality of Life, ADPKD Urinary Urgency, and ADPKD Urinary Frequency Questionnaires correlated with tolvaptan exposure, with high interindividual variability in responses. Changes in questionnaire scores were sensitive to changes in urine volume but not proportional to volume change, reflecting differences in subject tolerance to increased urine volume. Conclusion Tolvaptan MR exhibited predictable and dose-proportional pharmacokinetics and no improvement in tolerability versus tolvaptan IR. Tolerability of the urinary effects of treatment within the high-dose MR and IR groups exhibited substantial interindividual variability.",2020,"Changes in questionnaire scores were sensitive to changes in urine volume but not proportional to volume change, reflecting differences in subject tolerance to increased urine volume. ","['autosomal dominant polycystic kidney disease (ADPKD', 'patients with ADPKD', 'Each of 2 study arms had 12 subjects and 3 crossover periods']","['Tolvaptan MR', 'tolvaptan MR', 'placebo-masked QD', 'Modified-Release Versus Immediate-Release Tolvaptan', 'placebo']","['pharmacokinetic parameters, percentage of subjects with urine osmolality\xa0<300 mOsm/kg, urine volume, number of daily urine voids, and tolerability', 'ADPKD Nocturia Quality of Life, ADPKD Urinary Urgency, and ADPKD Urinary Frequency Questionnaires', 'questionnaire scores', 'pharmacokinetics, pharmacodynamics, and tolerability', 'Tolerability']","[{'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439353', 'cui_str': 'mosmol/kg'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.0326344,"Changes in questionnaire scores were sensitive to changes in urine volume but not proportional to volume change, reflecting differences in subject tolerance to increased urine volume. ","[{'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Department of Internal Medicine, Emory University School of Medicine, Atlanta, Georgia, USA; Section of Nephrology, University of Chicago School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Oberdhan', 'Affiliation': 'Health Outcomes, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': 'Clinical Development, Goldfinch Bio Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sergeyeva', 'Affiliation': 'Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Shoaf', 'Affiliation': 'Quantitative Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}]",Kidney international reports,['10.1016/j.ekir.2020.03.013'] 2423,32518862,The NOCTURNE Randomized Trial Comparing 2 Tolvaptan Formulations.,"Introduction Tolvaptan, a treatment for autosomal dominant polycystic kidney disease (ADPKD), inhibits vasopressin V2 receptor signaling, which causes aquaretic adverse events (AAEs). The short-term efficacy and tolerability of a once-daily, modified-release (MR) formulation was assessed relative to the twice-daily, immediate-release (IR) formulation. Methods This Phase 2 multicenter, randomized (1:1:1:1), placebo-controlled, double-blind, placebo-masked, parallel-group study (NCT01451827) compared tolvaptan MR 50 mg once daily or tolvaptan MR 80 mg once daily with tolvaptan IR 60/30 mg daily split dose and placebo over 8 weeks in 177 subjects. The primary endpoint was percent change from baseline in total kidney volume (TKV) at week 3. Other endpoints included tolerability, assessed by adverse events and quality of life (QOL) measures. Results Mean percentage decreases in TKV at week 3 were observed for the pooled group of all (MR+IR) tolvaptan-treated subjects (-2.07%), tolvaptan MR 80 mg (-2.55%), and tolvaptan MR 50 mg (-2.46%) versus placebo (0.09%; P  < 0.02 for each comparison with placebo), whereas the decrease with tolvaptan IR 60/30 mg (-1.17%; P  = 0.24) did not reach significance. All tolvaptan regimens were associated with AAEs, but scores on ADPKD-specific and generic patient-reported outcome assessments showed little impact based on dosage on overall health-related QOL versus placebo. Conclusion Tolvaptan MR and tolvaptan IR demonstrated similar short-term efficacy, tolerability, and safety, with low impact on multiple measures of QOL. Conclusions regarding long-term efficacy are limited by the short duration of follow-up.",2020,"Mean percentage decreases in TKV at week 3 were observed for the pooled group of all (MR+IR) tolvaptan-treated subjects (-2.07%), tolvaptan MR 80 mg (-2.55%), and tolvaptan MR 50 mg (-2.46%) versus placebo (0.09%; P  < 0.02 for each comparison with placebo), whereas the decrease with tolvaptan IR 60/30 mg (-1.17%; P  = 0.24) did not reach significance.","['autosomal dominant polycystic kidney disease (ADPKD', '177 subjects']","['tolvaptan MR', 'tolvaptan IR 60/30 mg daily split dose and placebo', 'placebo']","['tolerability, assessed by adverse events and quality of life (QOL) measures', 'Tolvaptan MR and tolvaptan IR demonstrated similar short-term efficacy, tolerability, and safety', 'total kidney volume (TKV', 'TKV']","[{'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",177.0,0.242103,"Mean percentage decreases in TKV at week 3 were observed for the pooled group of all (MR+IR) tolvaptan-treated subjects (-2.07%), tolvaptan MR 80 mg (-2.55%), and tolvaptan MR 50 mg (-2.46%) versus placebo (0.09%; P  < 0.02 for each comparison with placebo), whereas the decrease with tolvaptan IR 60/30 mg (-1.17%; P  = 0.24) did not reach significance.","[{'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Department of Internal Medicine, Emory University School of Medicine, Atlanta, Georgia, USA Section of Nephrology, University of Chicago School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Oberdhan', 'Affiliation': 'Health Outcomes, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': 'Goldfinch Bio Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sergeyeva', 'Affiliation': 'Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Shoaf', 'Affiliation': 'Clinical Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Rockville, Maryland, USA.'}]",Kidney international reports,['10.1016/j.ekir.2020.03.011'] 2424,32518865,Hemodialysis Does Not Induce Detectable Activation of the Contact System of Coagulation.,"Introduction Systemic anticoagulation is administered during hemodialysis to prevent clotting of the extracorporeal circuit. The role of contact system activation in thrombin generation during hemodialysis using current era dialyzer membranes is unknown. Methods We performed a single-center randomized crossover study. Ten patients treated with hemodialysis underwent 3 standardized hemodialysis sessions. For every patient, each session was performed with a different type of dialyzer membrane (polyphenylene [PP], polymethylmetacrylate [PMMA], polyethylenimine-coated polyacrylonitrile [AN69ST]). Blood samples were collected before and 5, 15, 30, 90, and 240 minutes after blood pump start to evaluate coagulation activation (thrombin-antithrombin complex [TAT], prothrombin fragment 1+2 [PF1+2], activated factor XII [FXIIa], kallikrein, activated factor XI [FXIa]). Plasma of healthy volunteers (n = 20) was used as a reference. Results Baseline TAT and PF1+2 levels were higher in hemodialysis patients compared to healthy controls (median [interquartile range] for TAT: 3.3 [2.9-4.2] vs. 2.4 [2.3-2.5] μg/l [ P  = 0.0002] and for PF1+2: 647 [478-737] vs. 138 [125-254] pmol/l [ P  < 0.0002]). Despite the use of systemic anticoagulation, TAT further increased during treatment, with the increase starting after 30 minutes (median TAT at t240: 9.0 μg/l (PP), 5.5 μg/l (PMMA), and 7.2 μg/l (AN69ST), all P  < 0.05 vs. baseline). Contact system markers FXIIa and kallikrein did not differ significantly between dialysis patients and healthy controls, whereas baseline FXIa levels were significantly lower in dialysis patients compared to healthy controls ( P  = 0.001). Levels of all contact system markers remained unchanged during hemodialysis with all types of dialyzer membranes. Conclusion Routine hemodialysis using systemic heparin anticoagulation induces coagulation activation without measurable contact system activation.",2020,"Results Baseline TAT and PF1+2 levels were higher in hemodialysis patients compared to healthy controls (median [interquartile range] for TAT: 3.3 [2.9-4.2] vs. 2.4 [2.3-2.5] μg/l [ P  = 0.0002] and for PF1+2: 647 [478-737] vs. 138 [125-254] pmol/l [ P  < 0.0002]).","['healthy volunteers (n\xa0= 20', 'Ten patients treated with hemodialysis underwent 3 standardized hemodialysis sessions']","['l', 'dialyzer membrane (polyphenylene [PP], polymethylmetacrylate [PMMA], polyethylenimine-coated polyacrylonitrile [AN69ST']","['baseline FXIa levels', 'Levels of all contact system markers', 'Baseline TAT and PF1+2 levels', 'Contact system markers FXIIa and kallikrein']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C1721154', 'cui_str': 'polyphenylene'}, {'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0032486', 'cui_str': 'Polyethylenimine'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0071503', 'cui_str': 'polyacrylonitrile'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0022478', 'cui_str': 'Kininogenase'}]",10.0,0.024575,"Results Baseline TAT and PF1+2 levels were higher in hemodialysis patients compared to healthy controls (median [interquartile range] for TAT: 3.3 [2.9-4.2] vs. 2.4 [2.3-2.5] μg/l [ P  = 0.0002] and for PF1+2: 647 [478-737] vs. 138 [125-254] pmol/l [ P  < 0.0002]).","[{'ForeName': 'Karlien', 'Initials': 'K', 'LastName': 'François', 'Affiliation': 'Division of Nephrology and Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Orlando', 'Affiliation': 'Department of Hematology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Jochmans', 'Affiliation': 'Department of Hematology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Cools', 'Affiliation': 'Interfaculty Center for Data Processing & Statistics, Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'De Meyer', 'Affiliation': 'Division of Nephrology and Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tielemans', 'Affiliation': 'Division of Nephrology and Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Karl Martin', 'Initials': 'KM', 'LastName': 'Wissing', 'Affiliation': 'Division of Nephrology and Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}]",Kidney international reports,['10.1016/j.ekir.2020.03.010'] 2425,32518867,A Cost-Minimization Analysis of Nurse-Led Virtual Case Management in Late-Stage CKD.,"Introduction Interventions are needed to improve early detection of indications for dialysis before development of severe symptoms or complications. This may reduce suboptimal dialysis starts, prevent hospitalizations, and decrease costs. Our objectives were to explore assumptions around a nurse-led virtual case management intervention for patients with late-stage chronic kidney disease (CKD) with a 2-year Kidney Failure Risk Equation (KFRE) estimated risk of kidney failure ≥80% and to estimate how these assumptions affect potential cost savings. Methods We performed a cost-minimization analysis by developing a decision analytic microsimulation model constructed from the perspective of the health payer. Our primary outcome was the break-even point, defined as the maximum amount a health payer could spend on the intervention without incurring any net financial loss or gain. The intervention group received remote telemonitoring, including daily measurement of several health metrics (blood pressure, oxygen saturation, and weight), and a validated symptom questionnaire accompanied by nurse-led case management, whereas the comparator group received usual care. We assumed patients received the intervention for a maximum of 2 years. Results The break-even point was $7339 per late-stage CKD patient enrolled in the intervention. Based on the distribution of time receiving the intervention, we determined a maximum monthly intervention cost of $703.37. In probabilistic sensitivity analyses, we found that 75% of simulations produced break-even points between $3929 and $9460. Conclusion Nurse-led virtual home monitoring interventions in patients with CKD at high risk of kidney failure have the potential for significant cost savings from the perspective of the health payer.",2020,"The intervention group received remote telemonitoring, including daily measurement of several health metrics (blood pressure, oxygen saturation, and weight), and a validated symptom questionnaire accompanied by nurse-led case management, whereas the comparator group received usual care.","['patients with CKD at high risk of kidney failure', 'patients with late-stage chronic kidney disease (CKD) with a 2-year Kidney Failure Risk Equation (KFRE) estimated risk of kidney failure\xa0≥80', 'Late-Stage CKD']","['nurse-led virtual case management intervention', 'remote telemonitoring, including daily measurement of several health metrics (blood pressure, oxygen saturation, and weight), and a validated symptom questionnaire accompanied by nurse-led case management, whereas the comparator group received usual care']",['net financial loss or gain'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0376243', 'cui_str': 'finances'}]",,0.034392,"The intervention group received remote telemonitoring, including daily measurement of several health metrics (blood pressure, oxygen saturation, and weight), and a validated symptom questionnaire accompanied by nurse-led case management, whereas the comparator group received usual care.","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Ferguson', 'Affiliation': 'Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Hager', 'Affiliation': 'Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Reid H', 'Initials': 'RH', 'LastName': 'Whitlock', 'Affiliation': 'Seven Oaks Hospital Chronic Disease Innovation Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Di Nella', 'Affiliation': 'Seven Oaks Hospital Chronic Disease Innovation Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Komenda', 'Affiliation': 'Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rigatto', 'Affiliation': 'Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",Kidney international reports,['10.1016/j.ekir.2020.03.016'] 2426,32518866,Sepsis-Associated Acute Kidney Disease.,"Introduction About one-third of critically ill patients with acute kidney injury (AKI) develop persistently decreased kidney function, known as acute kidney disease (AKD), which may progress to chronic kidney disease (CKD). Although sepsis is the most common cause of AKI, little is known about sepsis-associated AKD. Methods Using data from a large randomized trial including 1341 patients with septic shock, we studied patients with stage 2 or 3 AKI on day 1 of hospitalization. We defined AKD as a persistently reduced glomerular filtration rate for >7 days. In addition to clinical data, we measured several urinary biomarkers (tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 [TIMP-2∗IGFBP7], neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], liver-type fatty acid binding protein, and type 4 collagen) at 0, 6, and 24 hours, to predict AKD. Results Of 598 patients, 119 (19.9%) died within 7 days, 318 (53.2%) had early reversal of AKI within the first 7 days, whereas 161 (26.9%) developed AKD. In patients with early reversal, 45 (14.2%) had relapsed AKI after early reversal, and only about one-third of these recovered. Among patients developing AKD, only 15 (9.3%) recovered renal function prior to discharge. Male sex, African American race, and underlying CKD were more predominant in patients developing AKD. None of the biomarkers tested performed well for prediction of AKD, although NGAL modestly increased the performance of a clinical model. Conclusions AKD is common in patients with septic shock, especially among African American males and those with underlying CKD. Existing AKI biomarkers have limited utility for predicting AKD but might be useful together with clinical variables. Novel predictive biomarkers for renal recovery are needed.",2020,"None of the biomarkers tested performed well for prediction of AKD, although NGAL modestly increased the performance of a clinical model. ","['critically ill patients with acute kidney injury (AKI', 'patients with septic shock', '1341 patients with septic shock, we studied patients with stage 2 or 3 AKI on day 1 of hospitalization']",[],"['early reversal of AKI', 'renal function prior to discharge', 'glomerular filtration rate', 'several urinary biomarkers (tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 [TIMP-2∗IGFBP7], neutrophil gelatinase-associated lipocalin [NGAL], kidney injury molecule-1 [KIM-1], liver-type fatty acid binding protein, and type 4 collagen', 'relapsed AKI']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",[],"[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0532025', 'cui_str': 'insulin-like growth factor binding protein-related protein 1'}, {'cui': 'C0145988', 'cui_str': 'TIMP Proteins'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C1312700', 'cui_str': 'FABP1 protein, human'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",1341.0,0.0910354,"None of the biomarkers tested performed well for prediction of AKD, although NGAL modestly increased the performance of a clinical model. ","[{'ForeName': 'Sadudee', 'Initials': 'S', 'LastName': 'Peerapornratana', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Priyanka', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'Department of Medicine, Veterans Affairs Medical Center, San Diego, California, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The CRISMA (Clinical Research, Investigation and Systems Modeling of Acute Illness) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international reports,['10.1016/j.ekir.2020.03.005'] 2427,32518870,Randomized Clinical Trial on the Effect of Bardoxolone Methyl on GFR in Diabetic Kidney Disease Patients (TSUBAKI Study).,"Introduction Bardoxolone methyl significantly increases estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease (CKD). However, the phase 3 study, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus: the Occurrence of Renal Events (BEACON), was terminated prematurely because bardoxolone methyl increased the risk for early-onset fluid overload in patients with identifiable risk factors for heart failure (elevated baseline B-type natriuretic peptide levels >200 pg/ml and prior history of hospitalization for heart failure). The Phase 2 Study of Bardoxolone Methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI) study aimed to determine if patients without risk factors can mitigate the risk for fluid overload and whether changes in eGFR with bardoxolone methyl reflect true increases in GFR. Methods This phase 2, randomized, multicenter, double-blind, placebo-controlled study enrolled patients with type 2 diabetes and stage 3-4 CKD. Patients were randomized 1:1 to bardoxolone methyl (n = 41) or placebo (n = 41) (cohort G3), or 2:1 to bardoxolone methyl (n = 24) or placebo (n = 14) (cohort G4), administered orally once daily for 16 weeks using a dose-titration scheme. The primary efficacy endpoint was change from baseline in GFR measured by inulin clearance at week 16 in the cohort G3. Results A total of 40 patients were evaluated for the prespecified primary efficacy analysis. Mean change (95% confidence interval [CI]) from baseline in GFR was 5.95 (2.29 to 9.60) and -0.69 (-3.83 to 2.45) ml/min per 1.73 m 2 for patients randomized to bardoxolone methyl and placebo, respectively, with a significant intergroup difference of 6.64 ml/min per 1.73 m 2 ( P  = 0.008). Increases in the albumin/creatinine ratio were observed in the bardoxolone methyl group vs the placebo group. The most common adverse events (≥15% in either group) were viral upper respiratory tract infection, increased alanine aminotransferase, increased aspartate aminotransferase, increased γ-glutamyltransferase, and constipation. Peripheral edema was reported by 4 patients receiving bardoxolone methyl and by 1 patient receiving placebo; all events were mild and self-limiting. No patient died or experienced heart failure. The study discontinuation rate was higher in the bardoxolone methyl group (cohort G3, n = 8; cohort G4, n = 7) than the placebo group (cohort G3, n = 1; cohort G4, n = 0). Conclusion Bardoxolone methyl significantly increased measured GFR, and further investigation is ongoing to evaluate whether it provides clinical benefit without major safety concerns in selected patients with CKD.",2020,"The most common adverse events (≥15% in either group) were viral upper respiratory tract infection, increased alanine aminotransferase, increased aspartate aminotransferase, increased γ-glutamyltransferase, and constipation.","['enrolled patients with type 2 diabetes and stage 3-4 CKD', 'selected patients with CKD', 'Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI', 'Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus', 'patients with chronic kidney disease (CKD', '40 patients', 'Diabetic Kidney Disease Patients (TSUBAKI Study', 'patients with identifiable risk factors for heart failure (elevated baseline B-type natriuretic peptide levels >200 pg/ml and prior history of hospitalization for heart failure']","['Bardoxolone methyl', 'bardoxolone methyl', 'Bardoxolone Methyl Evaluation', 'bardoxolone methyl and placebo', 'Bardoxolone Methyl', 'placebo']","['albumin/creatinine ratio', 'viral upper respiratory tract infection, increased alanine aminotransferase, increased aspartate aminotransferase, increased γ-glutamyltransferase, and constipation', 'discontinuation rate', 'GFR measured by inulin clearance', 'glomerular filtration rate (eGFR', 'Mean change', 'patient died or experienced heart failure', 'Peripheral edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1100924', 'cui_str': 'methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0339916', 'cui_str': 'Viral upper respiratory tract infection'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1533636', 'cui_str': 'Inulin renal clearance measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}]",40.0,0.407772,"The most common adverse events (≥15% in either group) were viral upper respiratory tract infection, increased alanine aminotransferase, increased aspartate aminotransferase, increased γ-glutamyltransferase, and constipation.","[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Division of Nephrology and Endocrinology, University of Tokyo School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Kanda', 'Affiliation': 'Research & Development Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Takama', 'Affiliation': 'Research & Development Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ichikawa', 'Affiliation': 'Research & Development Division, Kyowa Kirin Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hase', 'Affiliation': 'Department of Nephrology, Toho University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Showa University School of Medicine, Tokyo, Japan.'}]",Kidney international reports,['10.1016/j.ekir.2020.03.030'] 2428,32518883,"Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial.","Background Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic. Methods The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. Dissemination The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences.",2020,"The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. ",['Patients who underwent'],"['open incisional hernia repair (IHR', 'incisional hernia repair', 'physical activity restrictions']","['quality of life', 'recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications', 'duration of sick leave that patients require to return to work', 'recurrence rate, physical activity restrictions (PAR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0950396,"The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. ","[{'ForeName': 'Katherina R', 'Initials': 'KR', 'LastName': 'Boettge', 'Affiliation': 'No Insurance Surgery, 653 N Town Center Drive, 89144 Las Vegas, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Croner', 'Affiliation': 'Department of General, Visceral, Vascular and Transplant Surgery, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Lefering', 'Affiliation': 'Department of General, Visceral, Vascular and Transplant Surgery, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lorenz', 'Affiliation': 'Department of General, Visceral, Vascular and Transplant Surgery, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Paasch', 'Affiliation': 'Department of General, Visceral, Vascular and Transplant Surgery, University Hospital Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.05.001'] 2429,32518891,"Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults.","This study was a phase III, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a seasonal trivalent split, inactivated influenza vaccine (TIV) in healthy Serbian adults between the ages of 18 and 65 years. This egg-based vaccine was manufactured by the Institute of Virology, Vaccines and Sera, Torlak, Belgrade, Serbia. A total of 480 participants were assigned randomly in a ratio of 2:1 to receive a single intramuscular dose (0.5 ml) of the vaccine (15 µg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Participants were monitored for safety, including solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs). No SAEs related to vaccination were reported. Injection site pain (51.3%), injection site tenderness (40.4%), tiredness (17.0%), and headache (15.1%) were the most commonly reported solicited events in the vaccine group. Incidence of related unsolicited AEs was low (1.3%) among vaccinees. Hemagglutinin inhibition (HAI) titers were measured before and 21 days after vaccination in 151 participants. Overall, HAI seroconversion rates to H1 and H3 were observed in 90.1% and 76.2% of vaccinees, respectively. For B antigen, it was 51.5%, likely due to high pre-vaccination titers. Post-vaccination seroprotection rates were in the range of 78.2-95.0% for the three antigens. Post-vaccination geometric mean titers (GMT) were at least 3.8 times higher than baseline levels for all the three strains among vaccinees. Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains. ClinicalTrials.gov identifier: NCT02935192, October 17, 2016.",2020,"Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains.","['151 participants', 'healthy Serbian adults between the ages of 18 and 65 years', 'A total of 480 participants', 'healthy Serbian adults']","['vaccine', 'vaccine (15 µg of hemagglutinin per strain) or placebo (phosphate-buffered saline', 'seasonal trivalent split, inactivated influenza vaccine (TIV', 'seasonal trivalent inactivated split influenza vaccine', 'placebo']","['headache', 'Injection site pain', 'Safety and immunogenicity', 'Post-vaccination seroprotection rates', 'Overall, HAI seroconversion rates to H1 and H3', 'safety and immunogenicity', 'safety, including solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs', 'tiredness', 'safe and well tolerated', 'injection site tenderness', 'Post-vaccination geometric mean titers (GMT', 'Incidence of related unsolicited AEs', 'Hemagglutinin inhibition (HAI) titers']","[{'cui': 'C2919513', 'cui_str': 'Serbian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0863083', 'cui_str': 'Injection site tenderness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",480.0,0.522828,"Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains.","[{'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stevanovic', 'Affiliation': 'Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade Faculty of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Obradovic', 'Affiliation': 'Jevremova Special gynecology hospital with maternity, Belgrade, Serbia.'}, {'ForeName': 'Snezana', 'Initials': 'S', 'LastName': 'Ristic', 'Affiliation': ""Institute for Students' Healthcare, Belgrade, Serbia.""}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Petrovic', 'Affiliation': 'Institute of Health Care of Workers of the Ministry of Internal Affairs, Belgrade, Serbia.'}, {'ForeName': 'Branislava', 'Initials': 'B', 'LastName': 'Milenkovic', 'Affiliation': 'Clinical Center of Serbia, Clinic for Pulmonology, Belgrade, Serbia.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Mitrovic', 'Affiliation': 'General Hospital Vrsac, Belgrade, Serbia.'}, {'ForeName': 'Svetlana Filipovic', 'Initials': 'SF', 'LastName': 'Vignjevic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ilic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Stoiljkovic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Lavadinovic', 'Affiliation': 'Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade Faculty of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Mijomir', 'Initials': 'M', 'LastName': 'Pelemis', 'Affiliation': 'Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade Faculty of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Petrovic', 'Affiliation': ""Institute for Students' Healthcare, Belgrade, Serbia.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vidmanic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Popovic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Eremic', 'Affiliation': 'Institute of Virology, Vaccines and Sera ""Torlak"", Belgrade, Serbia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Sparrow', 'Affiliation': 'The World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Torelli', 'Affiliation': 'The World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Socquet', 'Affiliation': 'PATH Switzerland, Geneva, Switzerland.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'PATH US, Seattle, WA, USA.'}, {'ForeName': 'Yordanka', 'Initials': 'Y', 'LastName': 'Ilieva-Borisova', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'PATH US, Seattle, WA, USA.'}, {'ForeName': 'Francesco Berlanda', 'Initials': 'FB', 'LastName': 'Scorza', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH US, Washington DC, USA.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Rathi', 'Affiliation': 'PATH India, 15th Floor, Dr Gopal Das Bhawan, 28, Barakhamba Road, Connaught Place, New Delhi, Delhi 110001, India.'}]",Therapeutic advances in vaccines and immunotherapy,['10.1177/2515135520925336'] 2430,32518895,"Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy.","Background Our study aimed to compare efficacy and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy. Methods Patients ( n  = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints-C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints. Results Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [- 6.0, 6.0], p  = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of - 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [- 0.03, 0.07], p  = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p  > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported. Conclusion Results demonstrated Hetero's adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy. Trial registration CTRI/2016/04/006884, Registered on 28/04/2016.",2020,No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p  > 0.05).,"['Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy', 'patients with active rheumatoid arthritis on concomitant methotrexate therapy', 'Total of 54 patients reported 88 AEs during the study', 'patients with active RA concomitantly on MTX therapy', 'Methods\n\n\nPatients ( n \u2009=\u2009168', '34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab']","[""Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc"", ""Hetero's adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc"", 'test or reference product for 24\u2009weeks with concomitant MTX']","['DAS28-CRP and HAQ-DI', 'serious adverse events (Sinusitis and Viral infection', 'Disease Activity Score of 28 joints-C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI', 'effective and well tolerated']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1171255', 'cui_str': 'Humira'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",168.0,0.142231,No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p  > 0.05).,"[{'ForeName': 'Shubhadeep', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Biswadip', 'Initials': 'B', 'LastName': 'Ghosh', 'Affiliation': 'Department of Rheumatology, Institute of Post Graduate Medical Education & Research & SSKM Hospital, 244, AJC Bose Road, Kolkata, West Bengal 700020 India.'}, {'ForeName': 'Syamasis', 'Initials': 'S', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Apollo Gleneagles Hospitals, Kolkata 58, Canal Circular Road, Kolkata, West Bengal 700054 India.'}, {'ForeName': 'Firdaus', 'Initials': 'F', 'LastName': 'Fatima', 'Affiliation': 'Vasavi Medical & Research Centre, 2nd floor, No.6-1-91, Opposite Meera talkies, Khairatabad, Hyderabad, Telangana 500004 India.'}, {'ForeName': 'Vamsi Krishna', 'Initials': 'VK', 'LastName': 'Bandi', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Thakur', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Bala', 'Initials': 'B', 'LastName': 'Reddy', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Sreenivasa', 'Initials': 'S', 'LastName': 'Chary', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Leela', 'Initials': 'L', 'LastName': 'Talluri', 'Affiliation': 'Hetero Biopharma Limited, Hyderabad, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Opp. MLB Medical College, Nirmal Hospital, Gate no-3, Jhansi, Uttar Pradesh 284128 India.'}, {'ForeName': 'Amit Ramchandra', 'Initials': 'AR', 'LastName': 'Kale', 'Affiliation': 'B. J. Medical College, Sassoon General Hospital, Pune, Maharashtra 411011 India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'GSVM Medical College, Swaroopa Nagar, Kanpur, U.P 208002 India.'}, {'ForeName': 'Ashok Kumar', 'Initials': 'AK', 'LastName': 'P', 'Affiliation': 'Andhra Medical College, Department of Orthopedics, King George Hospital, Visakhapatnam, Andhra Pradesh 530002 India.'}, {'ForeName': 'Diwakar', 'Initials': 'D', 'LastName': 'Reddy', 'Affiliation': ""St.Theresa's Hospital Erragadda, Sanathnagar, Hyderabad, Andhra Pradesh 500018 India.""}, {'ForeName': 'Younus', 'Initials': 'Y', 'LastName': 'Mohammed', 'Affiliation': 'M.Jeevan Jyoti Multispecialty hospital & Infertility Research Centre, 162 Bai Ka Bagh, Lowther Road, Allahabad, Uttar Pradesh 211003 India.'}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Shekar', 'Affiliation': 'Gurushree Hi-Tech Multi speicality Hopsital No.1558 Opp. Chandra layout Bus Stand Chandra Layout Vijaynagar, Bangalore, Karnataka 560040 India.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'T', 'Affiliation': 'Department of Orthopedics, Rajiv Gandhi Insititute of Medical Sciences & RIMS Government General Hospital, Srikakulam, 532001 India.'}, {'ForeName': 'Vijay G', 'Initials': 'VG', 'LastName': 'Goni', 'Affiliation': 'Department of orthopedic surgery, Post graduate institute of medical education & Research, Sect, Chandigarh, or-12 India.'}, {'ForeName': 'Vishnu', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'B.J. Medical College, Civil Hospital, Asarva, Ahmedabad, Gujarat 380016 India.'}, {'ForeName': 'Vishwanath', 'Initials': 'V', 'LastName': 'Yeligod', 'Affiliation': 'Sapthagiri Institute of Medical Sciences and Research Center #15, Chikkasandra, Hesaraghatta Main Road, Bangalore, Karnataka 560090 India.'}]",BMC rheumatology,['10.1186/s41927-020-00124-9'] 2431,32518906,The effects of cavity disinfection on the nanoleakage of compomer restorations: an in vitro study.,"Purpose Cavity disinfection, in addition to routine caries removal methods, is recommended to eliminate the microorganisms. The aim of this study was to compare the effect of various systems Er,Cr:YSGG lasers, diode lasers and FotoSan and agents Corsodyl; Cervitec and Cervitec Plus and Fluor Protector-on the nanoleakage of compomer restorations when used for cavity disinfection. Materials and methods A total of 40 intact human deciduous molar teeth containing Black V cavities (3×2×1.5 mm) on the buccal and lingual surfaces parallel to the cementoenamel junction were randomly divided into 8 groups according to the cavity disinfection methods. The antibacterial agents and systems were applied according to the manufacturer's instructions. Restorations were completed using a compomer. The restored teeth were then subjected to thermocycling for 500 cycles in a water bath at 5°C and 55°C with a dwell time of 30 seconds. After the thermocycling procedures, 1-mm sticks were obtained from the center of each cavity to prepare for the nanoleakage test. After the teeth were sectioned, they were immersed in 50 wt % ammoniacal silver nitrate solution for 24 hours and dipped in photo-developing solutions for 8 hours with fluorescent light irradiation. The samples were examined under a scanning electron microscope (SEM). The non-parametric Kruskal-Wallis and Mann-Whitney U test (p<0.05) were applied. Results The Er,Cr:YSGG laser group showed significantly less nanoleakage than all of the tested groups (p<0.01). The diode laser, Fluor protector and FotoSan groups showed similar nanoleakage to that of the control group (p>0.05). The Corsodyl (p<0.01) and Cervitec (p<0.001) groups showed significantly higher nanoleakage than the control group. Conclusion Er,Cr:YSGG laser irradiation which showed lower nanoleakage scores from either control or tested groups can be recommended for cavity disinfection Additionally, a diode laser and FotoSan, which have antibacterial effects and no negative effect on leakage, can be used for cavity disinfection.",2020,YSGG laser group showed significantly less nanoleakage than all of the tested groups (p<0.01).,['40 intact human deciduous molar teeth containing Black V cavities (3×2×1.5 mm) on the buccal and lingual surfaces parallel to the cementoenamel junction'],"['ammoniacal silver nitrate solution', 'diode laser, Fluor protector and FotoSan', 'YSGG lasers, diode lasers and FotoSan and agents Corsodyl; Cervitec and Cervitec Plus and Fluor Protector', 'cavity disinfection', 'Er,Cr', 'YSGG laser irradiation', 'YSGG laser']","['nanoleakage of compomer restorations', 'nanoleakage scores']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0227108', 'cui_str': 'Structure of deciduous molar tooth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0447311', 'cui_str': 'Structure of lingual surface of tooth'}, {'cui': 'C0227011', 'cui_str': 'Structure of cementoenamel junction'}]","[{'cui': 'C0051702', 'cui_str': 'ammoniacal silver'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0060511', 'cui_str': 'Fluor Protector'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0212384', 'cui_str': 'Cervitec'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0752145', 'cui_str': 'Polyacid-Modified Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.026676,YSGG laser group showed significantly less nanoleakage than all of the tested groups (p<0.01).,"[{'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Arslan', 'Affiliation': 'Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Pediatric Dentistry, Rize,Turkey.'}, {'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Baygin', 'Affiliation': 'Karadeniz Technical University, Faculty of Dentistry, Department of Pediatric Dentistry, Trabzon, Turkey.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Tuzuner', 'Affiliation': 'Karadeniz Technical University, Faculty of Dentistry, Department of Pediatric Dentistry, Trabzon, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Erdemir', 'Affiliation': 'Karadeniz Technical University, Faculty of Engineering, Department of Metallurgical and Materials Engineering, Trabzon,Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Canakci', 'Affiliation': 'Karadeniz Technical University, Faculty of Engineering, Department of Metallurgical and Materials Engineering, Trabzon,Turkey.'}, {'ForeName': 'Fatih Mehmet', 'Initials': 'FM', 'LastName': 'Korkmaz', 'Affiliation': 'Karadeniz Technical University, Faculty of Dentistry, Department of Prosthodontic, Trabzon,Turkey.'}]",European oral research,['10.26650/eor.20200053'] 2432,32518910,Horizontal continuous and apical stretching sutures does not reduce FGG shrinkage: a split-mouth randomized controlled clinical trial.,"Purpose This study aimed to evaluate whether horizontal continuous and apical stretching sutures could reduce FGG shrinkage. Materials and methods In this randomized controlled clinical trial ten patients (20 sites, seven females and three males) ranging from 18 to 53 years (average 39 years) with insufficient keratinized and attached gingiva received FGG in two quadrants of mandible (splitmouth design). Horizontal continuous and apical stretching sutures were used in test sites in addition to common suturing techniques. Clinical parameters including probing depth (PD), the width of keratinized and attached gingiva (KG, AG), the horizontal and vertical dimension of the graft (HD, VD), and graft area (GA) were recorded at baseline and 1, 3, and six months after the operation. Results PD did not differ significantly for six months. The average change of other parameters in test and control sites respectively was as follows: KG increased 5.5 mm and 5.1 mm, AG increased 5.3 mm and 5.1 mm, HD shrinkage was 21.6% and 15.8%, VD shrinkage was 33.7% and 33.2%, GA shrinkage was 47.3% and 43.3%. There were no significant differences between test and control sites in clinical parameters six months after surgery. Conclusion Application of horizontal continuous and apical stretching sutures does not reduce FGG shrinkage.",2020,"There were no significant differences between test and control sites in clinical parameters six months after surgery. ","['patients (20 sites, seven females and three males) ranging from 18 to 53 years (average 39 years) with insufficient keratinized and attached gingiva received FGG in two quadrants of mandible (splitmouth design']","['horizontal continuous and apical stretching sutures', 'Horizontal continuous and apical stretching sutures']","['HD shrinkage', 'VD shrinkage', 'FGG shrinkage', 'probing depth (PD), the width of keratinized and attached gingiva (KG, AG), the horizontal and vertical dimension of the graft (HD, VD), and graft area (GA', 'GA shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0688781,"There were no significant differences between test and control sites in clinical parameters six months after surgery. ","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shammas', 'Affiliation': 'University of Medical Sciences, Dental School, Department of Periodontics, Birjand, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Ranjbar', 'Affiliation': 'Iran University of Medical Sciences, Tehran Institute of Psychiatry- School of Behavioral Sciences and Mental Health, Mental Health Research Center, Tehran,Iran.'}, {'ForeName': 'Mohadeseh Arab', 'Initials': 'MA', 'LastName': 'Solghar', 'Affiliation': 'Kerman University of Medical Sciences, Dental School, Department of Periodontics, Kerman,Iran.'}, {'ForeName': 'Najme', 'Initials': 'N', 'LastName': 'Asghari', 'Affiliation': 'Kerman University of Medical Sciences, Kerman,Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Kerman University of Medical Sciences, Dental School, Department of Periodontics, Kerman,Iran.'}]",European oral research,['10.26650/eor.20200080'] 2433,32518932,"Effect of preoperative gabapentin after transurethral prostate resection under general anesthesia. A randomized double-blind, placebo-controlled trial.","OBJECTIVES To investigate whether preoperative oral gabapentin could reduce postoperative pain, analgesic consumption and the occurrence of catheter-related bladder discomfort (CRBD). Methods: In this study, participants randomly received either 600 mg gabapentin or placebo orally 2 h prior to transurethral prostate resection. Visual analogue scale and Ramsay sedation scale was utilized to assess pain intensity and sedation status after surgery. Intravenous 1.5 mg.kg-1 tramadol was used for postoperative analgesia. Pain intensity, sedation status, CRBD, tramadol consumption, side effects and the overall satisfaction degree were assessed and recorded for 48 h after tracheal extubation.  Results: Ninety participants given gabapentin and 91 participants given placebo completed the study. Lower visual analogue scale scores, less tramadol consumption, longer time to the first analgesic requirement, lower incidence of CRBD and nausea and higher satisfaction degree were detected in the patients receiving gabapentin compared with the patients receiving placebo.  Conclusion: Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.",2020,"Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.","['Ninety participants given', 'transurethral prostate resection under general anesthesia', 'and 91 participants given']","['Intravenous 1.5 mg.kg-1 tramadol', 'gabapentin', 'gabapentin or placebo', 'preoperative gabapentin', 'placebo']","['pain intensity and sedation status', ""postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction"", 'Visual analogue scale and Ramsay sedation scale', 'tramadol consumption, longer time to the first analgesic requirement, lower incidence of CRBD and nausea and higher satisfaction degree', 'postoperative pain, analgesic consumption and the occurrence of catheter-related bladder discomfort (CRBD', 'Pain intensity, sedation status, CRBD, tramadol consumption, side effects and the overall satisfaction degree', 'postoperative analgesia', 'Lower visual analogue scale scores']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",,0.349184,"Preoperative oral gabapentin reduced postoperative visual analogue scale scores, tramadol consumption and the occurrence rate of CRBD and nausea, and consequently, increased the degree of patients' satisfaction after transurethral prostate resection.","[{'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Hospital of Jilin University, Jilin, China. E-mail. wangjinguolily@163.com.'}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.6.25132'] 2434,31445454,Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer.,"BACKGROUND We assessed long-term cardiac safety and efficacy in patients with human epidermal growth factor receptor 2-positive early breast cancer treated with a trastuzumab biosimilar (SB3) or its reference product, trastuzumab (TRZ), in a phase 3 study. METHODS Patients who completed the phase 3 study could be enrolled in this extension study. The outcomes included the incidence of symptomatic congestive heart failure (CHF), asymptomatic significant left ventricular ejection fraction (LVEF) decrease, incidence of other cardiac events, event-free survival (EFS), and overall survival. In post hoc analysis, the Cox proportional hazards regression model was used to assess factors associated with EFS. RESULTS A total of 367 patients were enrolled in the study (SB3, n = 186; TRZ, n = 181). The median follow-up duration from the main study enrolment was 40.8 and 40.5 months for SB3 and TRZ, respectively. During the two-year follow-up after adjuvant therapy, incidence of asymptomatic significant LVEF decrease was rare (SB3, n = 1; TRZ, n = 2), with all patients recovering with LVEF ≥ 50%, and no cases of symptomatic CHF or other cardiac events were reported. At 3 years, the EFS was 91.9% with SB3 and 85.2% with TRZ. The number of patients with events was 17 (9.1%) with SB3 and 31 (17.1%) with TRZ [hazard ratio: 0.47, 95% confidence interval: 0.26-0.87]. Antibody-dependent cell-mediated cytotoxicity (ADCC) activity and the breast pathologic complete response rate were the factors associated with EFS. CONCLUSION Cardiotoxicity was rare in this extension study. EFS was higher with SB3 versus TRZ, with post hoc analysis suggesting that a downward drift in ADCC activity was a contributing factor. CLINICAL TRIAL REGISTRATION NUMBERS NCT02771795 (EudraCT 2015-005663-17).",2019,"EFS was higher with SB3 versus TRZ, with post hoc analysis suggesting that a downward drift in ADCC activity was a contributing factor. ","['367 patients were enrolled in the study (SB3, n\xa0=\xa0186', 'patients with human epidermal growth factor receptor 2-positive early breast cancer treated with a', 'human epidermal growth factor receptor 2-positive breast cancer', 'Patients who completed the phase 3 study could be enrolled in this extension study']","['SB3 versus TRZ', 'trastuzumab biosimilar (SB3) or its reference product, trastuzumab (TRZ', 'SB3 (a trastuzumab biosimilar) versus reference trastuzumab', 'TRZ']","['number of patients with events', 'EFS', 'symptomatic CHF\xa0or other cardiac events', 'incidence of symptomatic congestive heart failure (CHF), asymptomatic significant left ventricular ejection fraction (LVEF) decrease, incidence of other cardiac events, event-free survival (EFS), and overall survival', 'Antibody-dependent cell-mediated cytotoxicity (ADCC) activity and the breast pathologic complete response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0742758', 'cui_str': 'Symptomatic congestive heart failure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",367.0,0.0754379,"EFS was higher with SB3 versus TRZ, with post hoc analysis suggesting that a downward drift in ADCC activity was a contributing factor. ","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Paul Strauss Center, Strasbourg, France. Electronic address: xpivot@strasbourg.unicancer.fr.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pegram', 'Affiliation': 'Stanford Comprehensive Cancer Institute, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""Vall D'Hebron Institute of Oncology (VHIO), Barcelona and Ramon y Cajal University Hospital, Madrid, Spain.""}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lüftner', 'Affiliation': 'Charité Campus Benjamin Franklin, Humboldt University, Berlin, Germany.'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Lyman', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milano, Italy; University of Milano, Milano, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Ye Chan', 'Initials': 'YC', 'LastName': 'Yoon', 'Affiliation': 'Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.'}, {'ForeName': 'Younsoo', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.07.015'] 2435,32520718,Dose-response relationship of a Web-based Tailored Intervention Promoting HPV Vaccination: Process Evaluation.,"BACKGROUND In the Netherlands, HPV vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, Web-based tailored intervention for mothers of Dutch girls to-be-invited. OBJECTIVE The aim of this study is to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with (a) program acceptability, and (b) intervention effects (i.e., dose-response). METHODS Only mothers from the intervention arm of a randomized controlled study (RCT) that assessed the effectiveness of the Web-based, tailored intervention were included. They were invited to visit the Web-based intervention between baseline (January 2015, just before access to the intervention) and follow-up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (i.e., duration of intervention exposure) and completeness (i.e., the proportion of all available webpages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were informed decision-making (IDM), decisional conflict, and social psychological determinants of HPV vaccination uptake. RESULTS From the 3995 invited mothers, 2509 mothers (62.80%) logged in. Of these, 2239 mothers (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes on the website (SD = 12.41 minutes) and completed 50.04% (SD = 26.18%) of the website. Participants rated the website with a 7.64 on a 10-point scale (SD = 1.39). Program acceptability was significantly associated with completeness (β = 4.36, P < .001), but not with time of website use (β = -.07, P =.77). Intention-to-treat analysis (N = 3,995) showed a significant positive effect of completeness on all outcome measures (P's <.003; Bonferroni corrected alpha=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013). CONCLUSIONS Program use and acceptability of the intervention was adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (i.e., dose-response effects) were found of completeness and time of website use on the mothers IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the Web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. CLINICALTRIAL Trialregister.nl NTR4795; https://www.trialregister.nl/trial/4795.",2020,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013). ","['mothers of Dutch girls to-be-invited', '3995 invited mothers, 2509 mothers (62.80%) logged in', '2239 mothers (89.24%) visited at least one page of the intervention components']",[],"['decision-making (IDM), decisional conflict, and social psychological determinants of HPV vaccination uptake', 'Program acceptability', 'risk perception', 'HPV vaccination uptake', 'HPV vaccination uptake, acceptability, and IDM', 'completeness and time of website use on the mothers IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability', 'subjective norms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",[],"[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",3995.0,0.0847614,"Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013). ","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, NL.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Mollema', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, NL.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hofstra', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'Van Keulen', 'Affiliation': 'Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, NL.'}]",Journal of medical Internet research,['10.2196/14822'] 2436,32520721,"Interleukin-2 drives cortisol secretion in an age-, dose- and body composition-dependent way.","BACKGROUND Interleukin-2 (IL-2), one of the proinflammatory cytokines, is used in the treatment of certain malignancies. In some studies, transient increases in cortisol and ACTH secretion occurred. Thus, this agent may be used as an experimental probe of adrenal cortisol secretion. OBJECTIVE This study quantifies effects of low and moderate doses of IL-2 on cortisol secretion, and assesses the modulation by age, dose and body composition. Site: Mayo Clinical Translational Research Unit. SUBJECTS Study comprised 35 healthy men, 17 young and 18 older. METHODS Randomized prospective double-blind saline-controlled study of IL-2 administration in 2 doses with concurrent 10-min blood sampling for 24 h. OUTCOME MEASURES Deconvolution analysis and Approximate Entropy of cortisol secretion. RESULTS Low dose IL-2 administration increased nocturnal pulsatile cortisol secretion from 1460±160 to 2120±220 nmol/L/8h in young subjects and from 1680±105 to 1960±125 nmol/L/8h (treatment P<0.0001, but more in young than older, P=0.02). Comparable results were obtained for total cortisol secretion (P treatment <0.0001, age effect P=0.005). The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects. This dose also increased approximate entropy from 0.877±0.041 to 1.024±0.049 (P=0.008), pointing to reduced secretory orderliness. Incremental cortisol (nocturnal) secretion correlated negatively with visceral fat mass (R=-0.41, P=0.019). CONCLUSION In healthy men, IL-2 injection drives pulsatile cortisol secretion in a dose-dependent way in young, but not older, individuals, and erodes cortisol secretory orderliness at a higher dose in young subjects. Cortisol responses are diminished with increasing abdominal visceral fat mass.",2020,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","['35 healthy men, 17 young and 18 older', 'healthy men', 'Site']","['IL-2', 'IL-2 injection']","['Cortisol responses', 'nocturnal pulsatile cortisol secretion', 'Incremental cortisol (nocturnal) secretion', 'Deconvolution analysis and Approximate Entropy of cortisol secretion', 'visceral fat mass', 'total cortisol secretion', 'cortisol and ACTH secretion', 'Interleukin-2 drives cortisol secretion']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",35.0,0.0249157,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'F Roelfsema, Endocrinology and Metabolism, Leiden University Medical Center, Leiden, 2333ZA, Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'P Liu, Medicine, David Geffen School of Medicine, Los Angeles, United States.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'R Yang, Endocrine Research Unit, Mayo Clinic Rochester, Rochester, United States.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'P Takahashi, Endocrine Research Unit, Mayo Clinic, Rochester, United States.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'J Veldhuis, Endocrine Research Unit, Mayo Clinic, Rochester, 55905, United States.'}]",Endocrine connections,['10.1530/EC-20-0211'] 2437,32520816,The Effects of a Pain Psychology and Neuroscience Self-Evaluation Internet Intervention: A Randomized Controlled Trial.,"OBJECTIVES Many patients' chronic musculoskeletal pain is strongly influenced by central nervous system processes such as sensitization or amplification. Education about pain neuroscience can change patients' beliefs but has less consistent effects on pain outcomes. Patients may have greater clinical benefits if the educational intervention is personalized, and they evaluate various psychosocial risk factors with respect to their pain. We developed and tested a brief, internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention. METHODS From a patient registry, 104 adults reporting chronic musculoskeletal pain were randomized to the PPN intervention or a matched, active, education control condition. At baseline and 1-month (primary endpoint) and 10-month follow-ups, participants reported pain severity (primary outcome) and multiple secondary outcomes. Primary analyses compared the two experimental conditions using ANCOVAs; post-hoc exploratory analyses compared the effects of PPN in subgroups of patients who met criteria for fibromyalgia (FM; n=50) or who did not (n=54; primarily spinal pain). RESULTS At 1-month follow-up, compared to the control condition, PPN led to significantly lower pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management (ηp=0.08). Effects on distress, pain catastrophizing, kinesiophobia, and life satisfaction were not significant. Exploratory analyses showed that the PPN intervention was especially beneficial for patients without FM but was of less benefit for those with FM. Most of the effects (except attributions) were lost at 10 months. DISCUSSION A brief pain psychology and neuroscience self-evaluation intervention, presented on-line, can yield short-term improvements in musculoskeletal pain severity and interference, especially for people with spinal/localized pain rather than FM, perhaps because the psychology/neuroscience perspective is more novel for such patients.",2020,"At 1-month follow-up, compared to the control condition, PPN led to significantly lower pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management (ηp=0.08).","['104 adults reporting chronic musculoskeletal pain', ""patients' chronic musculoskeletal pain"", 'From a patient registry']","['internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention', 'PPN intervention or a matched, active, education control condition', 'PPN intervention', 'Pain Psychology and Neuroscience Self-Evaluation Internet Intervention', 'PPN']","['pain outcomes', 'pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management', 'distress, pain catastrophizing, kinesiophobia, and life satisfaction', 'pain severity']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",104.0,0.06102,"At 1-month follow-up, compared to the control condition, PPN led to significantly lower pain severity (ηp=0.05) and interference (ηp=0.04), greater brain (ηp=0.07) and psychological (ηp=0.07) attributions for pain, and greater readiness for pain self-management (ηp=0.08).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kohns', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Urbanik', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Geisser', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Providence Hospital and Michigan State University, Southfield, Michigan, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000857'] 2438,32520828,"""Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine vs Cyclosporine: A Randomized Trial"".","OBJECTIVE To study the outcome and adverse effects of two initial treatments in children with autoimmune hepatitis (AIH), prednisone (PRED) plus azathioprine (AZA) vs cyclosporine (CsA). STUDY DESIGN Between 12/2008-2/2012, 50 consecutive patients were centrally randomized to one of two treatment arms. Group 1: PRED was indicated at a dose of 1-2 mg/kg/day (up to 60 mg/day) and AZA at a dose of 1-2 mg/kg/day. Group 2: CsA was administered at a dose of 4 mg/kg/day orally divided into two doses. After remission, all patients were given a combination of PRED at 0.3 - 0.5 mg/kg/day and AZA at 1-2 mg/kg/day. Children presenting liver failure (LF) were placed on a triple immunosuppressive regimen if this condition persisted after one week of treatment, after liver function normalization they were switched back to their initial scheme. RESULTS 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081). All children recovered liver function in a mean time of 32 ± 26 days. Cushingoid syndrome was more frequently observed with PRED-AZA (p < 0.001) and gingival hypertrophy with CsA (p < 0.001). A significant increase in body mass index (BMI) was observed in all patients from initial treatment to remission, being greater with PRED-AZA. CONCLUSIONS Similar outcomes were obtained with PRED plus AZA or CsA treatments. Either therapeutic strategy could be used according to the particular characteristics of each patient. Triple immunosuppression was beneficial in patients with liver failure at onset.",2020,"RESULTS 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","['Children presenting liver failure (LF', '50 consecutive patients', 'Autoimmune Hepatitis in Children', 'patients with liver failure at onset', 'Between 12/2008-2/2012', 'children with autoimmune hepatitis (AIH']","['prednisone (PRED) plus azathioprine (AZA) vs cyclosporine (CsA', 'Cyclosporine', 'Triple immunosuppression', 'AZA', 'Prednisone Plus Azathioprine', 'CsA']","['Cushingoid syndrome', 'effectiveness and safety', 'PRED', 'gingival hypertrophy with CsA', 'liver function', 'body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0332601', 'cui_str': 'Cushingoid facies'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0017567', 'cui_str': 'Hypertrophy of gingiva'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.0972557,"RESULTS 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Cuarterolo', 'Affiliation': 'Hepatology Unit, Gastroenterology Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Ciocca', 'Affiliation': 'Hepatology Unit, Gastroenterology Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'López', 'Affiliation': 'Hepatology Unit, Gastroenterology Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'Nutrition Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Álvarez', 'Affiliation': 'Department of Pediatrics, CHU-Sainte Justine, University of Montreal, Canada.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002776'] 2439,32520870,Sedentary Time and Physical Activity in Older Women Undergoing Exercise Training.,"Older adults have low rates meeting the physical activity (PA) guidelines and high sedentary time. Low PA and excessive sedentary time have been linked to adverse health outcomes. Less is known about whether exercise training influences sedentary time and PA in various intensities. PURPOSE To examine the effects of a 16-week aerobic exercise training on time spent being sedentary and on PA time of light (LPA) and moderate-to-vigorous (MVPA) intensities, and step numbers in older women. METHODS Inactive women (n = 61; age = 65.5 ± 4.3 years) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively). They wore a SenseWear Mini Armband at baseline and at end-intervention to determine sedentary, LPA, and MVPA time, and step numbers. RESULTS Time being sedentary, or spent on LPA and MVPA, did not change differently by exercise groups with different doses (all p values for group by time interaction > 0.580). Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003). MVPA time increased (p < 0.001), which was primarily accounted for by the supervised exercise. Interestingly, daily steps increased more in the moderate-dose than the low-dose group (p = 0.023 for group by time interaction; 33.6% and 19.8% median increase in moderate- and low-dose groups, respectively). Also, there were individual differences in these changes. CONCLUSION Results indicated that on average, older women did not reduce time of LPA or MVPA outside of the exercise program, or increase sedentary time as a result of participating in the exercise program.",2020,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","['older women', 'Older Women Undergoing Exercise Training', 'Older adults', 'Inactive women (n = 61; age = 65.5 ± 4.3 years) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively']","['exercise training', 'aerobic exercise training']","['sedentary time', 'time spent being sedentary and on PA time of light (LPA) and moderate-to-vigorous (MVPA) intensities, and step numbers', 'Sedentary Time and Physical Activity', 'MVPA time', 'LPA']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}]",61.0,0.0344794,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","[{'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Charity B', 'Initials': 'CB', 'LastName': 'Breneman', 'Affiliation': ''}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sparks', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002407'] 2440,32520874,Effects of the Turbine™ on Ventilatory and Sensory Responses to Incremental Cycling.,"INTRODUCTION The Turbine™ is a nasal dilator marketed to athletes to increase airflow, which may serve to reduce dyspnea and improve exercise performance, presumably via reductions in the work of breathing (WOB). However, the unpublished data supporting these claims were collected in individuals at rest that were exclusively nasal breathing. These data are not indicative of how the device influences breathing during exercise at higher ventilations when a larger proportion of breathing is through the mouth. Accordingly, the purpose of this study was to empirically test the efficacy of the Turbine™ during exercise. We hypothesized that the Turbine™ would modestly reduce the WOB at rest and very low exercise intensities but would have no impact on the WOB at moderate-to-high exercise intensities. METHODS We conducted a randomized, cross-over study in young, healthy individuals (7M:1F; age=27±5yrs) with normal lung function. Each participant performed two incremental cycle exercise tests to exhaustion with a Turbine™ device or under a sham control condition. For the sham control condition, participants were told they were breathing a low-density gas to reduce the WOB, but were actually breathing room air. The WOB was determined through the integration of ensemble averaged esophageal pressure-volume loops. Standard cardio-respiratory measures were recorded using a commercially available metabolic cart. Dyspnea was assessed throughout exercise using the 0-10 Borg scale. RESULTS Peak V[Combining Dot Above]O2 and work rate were not different between conditions (p=0.70 and p=0.35, respectively). Additionally, there was no interaction or main effect of condition on dyspnea (p=0.71), ventilation (p=0.22) or WOB (p=0.30) throughout exercise. CONCLUSION These findings suggest that the Turbine™ does not reduce the WOB and has no effect on dyspnea or exercise capacity.",2020,"Dot Above]O2 and work rate were not different between conditions (p=0.70 and p=0.35, respectively).","['young, healthy individuals (7M:1F; age=27±5yrs) with normal lung function']","['Turbine', 'incremental cycle exercise tests to exhaustion with a Turbine™ device or under a sham control condition', 'V[Combining']","['Dyspnea', 'Dot Above]O2 and work rate', 'dyspnea (p=0.71), ventilation (p=0.22) or WOB', 'dyspnea or exercise capacity', 'WOB', 'Ventilatory and Sensory Responses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0438186', 'cui_str': 'Lung function testing normal'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",,0.0588261,"Dot Above]O2 and work rate were not different between conditions (p=0.70 and p=0.35, respectively).","[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Schaeffer', 'Affiliation': ""Centre for Heart Lung Innovation, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'McBride', 'Affiliation': 'Life Science Division, Quest University Canada, Squamish, BC, Canada.'}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': ""Centre for Heart Lung Innovation, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Kyle G', 'Initials': 'KG', 'LastName': 'Boyle', 'Affiliation': ""Centre for Heart Lung Innovation, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': ""Centre for Heart Lung Innovation, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Puyat', 'Affiliation': ""Centre for Health Evaluation & Outcome Sciences, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}, {'ForeName': 'Meaghan J', 'Initials': 'MJ', 'LastName': 'MacNutt', 'Affiliation': 'Life Science Division, Quest University Canada, Squamish, BC, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': ""Centre for Heart Lung Innovation, Providence Health Care Research Institute, The University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002427'] 2441,32520876,Exercise and Protein Effects on Strength and Function with Weight Loss in Older Women.,"Obesity negatively impacts lower extremity physical function (LEPF) in older adults. Exercise and a higher protein diet are both known to positively and independently impact body composition, muscle strength and LEPF during weight loss; however, their potential interactive effects have not been well characterized in older women. PURPOSE The aim of this study was to determine the relative efficacy of a higher protein diet with or without exercise to improve body composition, muscle strength, and LEPF in older inactive overweight/obese women after weight loss. METHODS Postmenopausal women (BMI=31.1±5.1 kg/m, 69.2±3.6 y) completed a 6-month weight loss program after randomization to three groups (n=72 randomized; 15% drop-out): 1) higher protein diet (PRO, ~30% energy from protein; n=20), 2) PRO plus exercise (PRO+EX; n=19), or 3) a conventional protein control diet plus EX (CON+EX, ~18% energy from protein; n=22). EX was supervised, multicomponent (aerobic, muscle strengthening, balance, flexibility) and 3 sessions/week. Body composition was measured via dual-energy X-ray absorptiometry; leg strength by isokinetic dynamometry; and LEPF via 6-minute walk, 8-foot up and go, and 30-second chair stand tests. RESULTS Changes in weight (-7.5±4.1 kg; -9.2±4.8%), fat mass, and leg lean mass did not differ among groups (all P>0.50). Despite weight loss, muscle strength improved in the exercise groups (PRO+EX and CON+EX) whereas it declined in the PRO group (P=0.008). For all LEPF measures, the PRO group had attenuated improvements compared to both PRO+EX and CON+EX (all P<0.01). CONCLUSION Exercise during weight loss is critical to preserve strength and enhance LEPF; however, a higher protein diet does not appear to influence body composition, muscle strength or LEPF changes when combined with multicomponent exercise.",2020,"For all LEPF measures, the PRO group had attenuated improvements compared to both PRO+EX and CON+EX (all P<0.01). ","['older women', 'Older Women', 'older adults', 'Postmenopausal women (BMI=31.1±5.1 kg/m, 69.2±3.6 y) completed a 6-month weight loss program after randomization to three groups (n=72 randomized; 15% drop-out): 1', 'older inactive overweight/obese women after weight loss']","['higher protein diet with or without exercise', 'higher protein diet (PRO, ~30% energy from protein; n=20), 2) PRO plus exercise (PRO+EX; n=19), or 3) a conventional protein control diet plus EX (CON+EX']","['Body composition', 'extremity physical function (LEPF', 'fat mass, and leg lean mass', 'Strength and Function with Weight Loss', 'Despite weight loss, muscle strength', 'body composition, muscle strength, and LEPF']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0205205,"For all LEPF measures, the PRO group had attenuated improvements compared to both PRO+EX and CON+EX (all P<0.01). ","[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Evans', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA.'}, {'ForeName': 'Chad R', 'Initials': 'CR', 'LastName': 'Straight', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA.'}, {'ForeName': 'Rachelle A', 'Initials': 'RA', 'LastName': 'Reed', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Berg', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, GA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rowe', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Johnson', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska Lincoln, Lincoln, NE.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002429'] 2442,32520891,Effects of Different Doses of Remote Ischemic Preconditioning on Kidney Damage Among Patients Undergoing Cardiac Surgery: A Single-Center Mechanistic Randomized Controlled Trial.,"OBJECTIVES We have previously shown that remote ischemic preconditioning reduces acute kidney injury (acute kidney injury) in high-risk patients undergoing cardiopulmonary bypass and that the protective effect is confined to patients who exhibit an increased urinary tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 in response to remote ischemic preconditioning. The purpose of this study was to determine the optimal intensity of remote ischemic preconditioning to induce required [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] changes and further explore mechanisms of remote ischemic preconditioning. DESIGN Observational and randomized controlled, double-blind clinical trial. SETTING University Hospital of Muenster, Germany. PATIENTS High-risk patients undergoing cardiac surgery as defined by the Cleveland Clinic Foundation Score. INTERVENTIONS In the interventional part, patients were randomized to receive either one of four different remote ischemic preconditioning doses (3 × 5 min, 3 × 7 min, 3 × 10 min remote ischemic preconditioning, or 3 × 5 min remote ischemic preconditioning + 2 × 10 min remote ischemic preconditioning in nonresponders) or sham-remote ischemic preconditioning (control). MEASUREMENTS AND MAIN RESULTS The primary endpoint of the interventional part was change in urinary [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] between pre- and postintervention. To examine secondary objectives including acute kidney injury incidence, we included an observational cohort. A total of 180 patients were included in the trial (n = 80 observational and n = 100 randomized controlled part [20 patients/group]). The mean age was 69.3 years (10.5 yr), 119 were men (66.1%). Absolute changes in [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] were significantly higher in all remote ischemic preconditioning groups when compared with controls (p < 0.01). Although we did not observe a dose-response relationship on absolute changes in [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] across the four different remote ischemic preconditioning groups, in the 15 patients failing to respond to the lowest dose, nine (60%) responded to a subsequent treatment at a higher intensity. Compared with controls, fewer patients receiving remote ischemic preconditioning developed acute kidney injury within 72 hours after surgery as defined by both Kidney Disease: Improving Global Outcomes criteria (30/80 [37.5%] vs 61/100 [61.0%]; p = 0.003). CONCLUSIONS All doses of remote ischemic preconditioning significantly increased [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] and significantly decreased acute kidney injury compared with controls. High-dose remote ischemic preconditioning could stimulate [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] increases in patients refractory to low-dose remote ischemic preconditioning.",2020,"Compared with controls, fewer patients receiving remote ischemic preconditioning developed acute kidney injury within 72 hours after surgery as defined by both Kidney Disease: Improving Global Outcomes criteria (30/80 [37.5%] vs 61/100 [61.0%]; p = 0.003). ","['University Hospital of Muenster, Germany', 'High-risk patients undergoing cardiac surgery as defined by the Cleveland Clinic Foundation Score', 'A total of 180 patients were included in the trial (n = 80 observational and n = 100 randomized controlled part [20 patients/group', 'The mean age was 69.3 years (10.5 yr), 119 were men (66.1', 'Patients', 'Undergoing Cardiac Surgery', 'high-risk patients undergoing', 'acute kidney injury incidence']","['cardiopulmonary bypass', 'metalloproteinases-2]*[insulin-like growth factor-binding protein 7', 'remote ischemic preconditioning doses (3 × 5 min, 3 × 7 min, 3 × 10 min remote ischemic preconditioning, or 3 × 5 min remote ischemic preconditioning + 2 × 10 min remote ischemic preconditioning in nonresponders) or sham-remote ischemic preconditioning (control', 'Remote Ischemic Preconditioning']","['acute kidney injury', 'Kidney Damage', 'urinary [tissue inhibitor of metalloproteinases-2]*[insulin-like growth factor-binding protein 7] between pre- and postintervention']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",180.0,0.22112,"Compared with controls, fewer patients receiving remote ischemic preconditioning developed acute kidney injury within 72 hours after surgery as defined by both Kidney Disease: Improving Global Outcomes criteria (30/80 [37.5%] vs 61/100 [61.0%]; p = 0.003). ","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Pavenstädt', 'Affiliation': 'Department of Medicine, Division D, Nephrology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rossaint', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiac Surgery, University of Münster, Münster, Germany.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Klausmeyer', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Elisa A', 'Initials': 'EA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kerschke', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.'}]",Critical care medicine,['10.1097/CCM.0000000000004415'] 2443,32520897,Dynamic Impact of Transfusion Ratios on Outcomes in Severely Injured Patients: Targeted Machine Learning Analysis of the PROPPR Randomized Clinical Trial.,"BACKGROUND Massive transfusion protocols to treat post-injury hemorrhage are based on pre-defined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury. METHODS The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 level-I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semi-parametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different time-points during the first 24 hours after admission. RESULTS In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma:PRBC and high platelet:PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% CI = 1.19-5.22) during the 3 hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis. CONCLUSIONS Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission. LEVEL OF EVIDENCE Prognostic, level III.",2020,"Overall, the transfusion ratios had no significant impact on mortality over time.","['680 severely injured patients required massive transfusion', 'Severely Injured Patients', '12 level-I trauma centers in North America']",['Transfusion Ratios'],"['relative risk of achieving hemostasis', 'mortality', 'probability of hemostasis', 'actual ratios and mortality']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",680.0,0.326126,"Overall, the transfusion ratios had no significant impact on mortality over time.","[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley New affiliation since the work was done: Center for Biomedical Informatics Research, Department of Biomedical Data Science, School of Medicine, Stanford University Department of Anesthesia and Perioperative Care, School of Medicine, University of California, San Francisco Department of Surgery, School of Medicine, University of California, San Francisco Department of Surgery, School of Medicine, University of California, San Francisco Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston Center for Translational Injury Research, Department of Surgery, Medical School, University of Texas Health Science Center, Houston Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland Center for Translational Injury Research, Department of Surgery, Medical School, University of Texas Health Science Center, Houston Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley Department of Surgery, School of Medicine, University of Colorado Division of Epidemiology and Biostatistics, School of Public Health, University of California, Berkeley.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pirracchio', 'Affiliation': ''}, {'ForeName': 'Lucy Z', 'Initials': 'LZ', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Callcut', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002819'] 2444,32520900,Associations of pituitary-ovarian hormones and white matter hyperintensities in recently menopausal women using hormone therapy.,"OBJECTIVE Little is known about how menopausal hormone treatment (HT) may influence the development of white matter hyperintensities (WMHs) in the brain. This study evaluated the associations of changes in levels of pituitary-ovarian hormones during HT and changes in WMH. METHODS Women (n = 78 adherent to treatment) enrolled in the Kronos Early Estrogen Prevention Study underwent brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45 mg/d oral conjugated equine estrogen (oCEE) daily, 50 μg/d transdermal 17β estradiol (tE2), or placebo pills and patches. Women in the active treatment groups also received oral 200 mg/d micronized progesterone the first 12 days of the month. Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum by high sensitivity liquid chromatography/mass spectrometry at baseline and following 48 months of HT. Longitudinal change in WMH volume was determined from fluid-attenuated inversion recovery magnetic resonance imaging using a semiautomated image segmentation algorithm. RESULTS Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline. After 48 months of treatment, smaller increases in WMH associated with decreases in FSH from baseline in the tE2 group and increases in E1 in both tE2 and oCEE groups. Changes in LH did not associate with changes in WMH in any group. CONCLUSIONS Circulating levels of pituitary-ovarian hormones associate with changes in WMH volume in recently menopausal women using HT. Whether these relationships would be influenced by different doses of tE2 or oCEE remains to be determined. : Video Summary:http://links.lww.com/MENO/A590.",2020,"RESULTS Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","['Women (n\u200a=\u200a78 adherent to treatment) enrolled in the Kronos', '50']","['transdermal 17β estradiol (tE2), or placebo pills and patches', ' Video Summary:http://links.lww.com/MENO/A590', 'brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45\u200amg/d oral conjugated equine estrogen (oCEE', 'hormone therapy', 'menopausal hormone treatment (HT', 'oral 200\u200amg/d micronized progesterone']","['Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'WMH', 'Serum levels of FSH, LH, E1, or E2', 'levels of pituitary-ovarian hormones', 'FSH', 'WMH volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0729511', 'cui_str': 'Ovarian hormone'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.216075,"RESULTS Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","[{'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Kling', 'Affiliation': ""Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, 13737 North 92nd Street, Scottsdale, AZ 85260.""}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nirubol', 'Initials': 'N', 'LastName': 'Tosakulwong', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lesnick', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, MN.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001557'] 2445,32520909,Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.,"BACKGROUND Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age. METHODS This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation. FINDINGS Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. CONCLUSIONS POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.",2020,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. ","['18 health facilities', 'Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC', 'Early Infant Diagnosis of HIV']","['routine POC versus laboratory-based EID', 'Routine Point-of-Care Versus Laboratory Testing']",['time to antiretroviral therapy initiation'],"[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",9539.0,0.210826,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. ","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sacks', 'Affiliation': 'Department of Global Health, George Washington School of Public Health, Washington, DC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ochuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Haurovi', 'Initials': 'H', 'LastName': 'Mafaune', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Addmore', 'Initials': 'A', 'LastName': 'Chadambuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Odhiambo', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Masaba', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Githuka', 'Affiliation': 'Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mahomva', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mushavi', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Lemaire', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Bianchi', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}, {'ForeName': 'Rhoderick', 'Initials': 'R', 'LastName': 'Machekano', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002383'] 2446,32520984,Effect of various exercises on frailty among older adults with subjective cognitive concerns: a randomised controlled trial.,"BACKGROUND Physical exercise has been linked to reduced frailty, but there is insufficient evidence of beneficial effects in community-dwelling older adults with subjective cognitive concerns. OBJECTIVE This study aimed to clarify the effects of physical exercise in this population. DESIGN Single-blind randomised controlled trial. SETTING Community sports centres. PARTICIPANTS Residents aged 65-85 years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomised. METHODS This trial investigated the effects of aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs on reducing frailty. All participants were randomised into one of the three intervention groups or the control group. Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. A 95-item frailty index (FI) was utilised to determine the effects of training. Participants were followed up at weeks 26 and 52. RESULTS At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean FI score of 0.3 ± 0.1. Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52. No significant differences in FI were found in RT and AT+RT groups at weeks 26 and 52. CONCLUSIONS A 26-week AT reduced frailty modestly, especially in the depression and anxiety component, in older adults with subjective cognitive concerns.",2020,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","['Community sports centres', 'older adults with subjective cognitive concerns', '415 community-dwelling older adults', 'Residents aged 65-85\xa0years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment', 'community-dwelling older adults with subjective cognitive concerns']","['various exercises', 'lectures about health promotion', 'aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs', 'physical exercise', 'group training program and self-paced home training']","['FI', 'total FI', 'depression and anxiety component of FI']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",415.0,0.0634744,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","[{'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu City, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Age and ageing,['10.1093/ageing/afaa086'] 2447,32520991,"l-Serine and EPA Relieve Chronic Low-Back and Knee Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND Multisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life. OBJECTIVES This study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo. METHODS This was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates. RESULTS The JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P < 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11-27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed. CONCLUSIONS l-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment.This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.",2020,"No adverse events were observed. ","['120 participants aged\xa0≥20 y (36 men and 84 women: mean\xa0±\xa0SD age = 40.8\xa0±\xa010.9 y', 'Adults', 'adults with pain in at least the low back and knee for\xa0≥3 mo']","['Placebo', 'l-Serine and EPA', 'l-serine', 'l-Serine and EPA Relieve', 'mg l-serine and 149\xa0mg EPA', 'active group (daily ingestion of 594', 'placebo']","['Chronic Low-Back and Knee Pain', 'JKOM scores', 'BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving', 'BPI5D', 'pain relief', 'Brief Pain Inventory (BPI) and safety evaluation', 'JLEQ scores', 'adverse events', 'Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.682536,"No adverse events were observed. ","[{'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Sasahara', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Suga', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Nishikata', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Takada', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Direct Marketing Department, Ajinomoto Co, Inc, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Mine', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kobuna', 'Affiliation': 'Kobuna Orthopedic Clinic, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa156'] 2448,32521007,HOME2: Household vs. Personalized Decolonization in Households of Children with Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection - A Randomized Clinical Trial.,"BACKGROUND A household approach to decolonization decreases skin and soft tissue infection (SSTI) incidence, though this is burdensome and costly. As prior SSTI increases risk for SSTI, we hypothesized the effectiveness of decolonization measures to prevent SSTI when targeted to household members with prior year SSTI would be non-inferior to decolonizing all household members. METHODS Upon completion of our 12-month observational HOME study, 102 households were enrolled in HOME2, a 12-month, randomized non-inferiority trial. Pediatric index patients with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) SSTI, their household contacts, and pets were enrolled. Households were randomized 1:1 to the Personalized (decolonization performed only by household members who experienced SSTI during the HOME study) or Household (decolonization performed by all household members) approaches. The 5-day regimen included hygiene education, twice-daily intranasal mupirocin, and daily bleach-water baths. At 5 follow-up visits in participants' homes, swabs to detect S. aureus were collected from participants, environmental surfaces, and pets; incident SSTI were ascertained. RESULTS Non-inferiority of the Personalized Approach was established for the primary outcome 3-month cumulative SSTI: 23 of 212 (10.8%) participants reported SSTI in Household Approach households, while 23 of 236 (9.7%) participants reported SSTI in Personalized Approach households; difference in proportions -1.1% (95% CI -6.7%, 4.5%). In multivariable analyses, prior year SSTI and baseline MRSA colonization were associated with cumulative SSTI. CONCLUSIONS The Personalized Approach was non-inferior to the Household Approach in preventing SSTI. Future studies should interrogate longer durations of decolonization and/or decontamination of the household environment to reduce household MRSA burden.",2020,"RESULTS Non-inferiority of the Personalized Approach was established for the primary outcome 3-month cumulative SSTI: 23 of 212 (10.8%) participants reported SSTI in Household Approach households, while 23 of 236 (9.7%) participants reported SSTI in Personalized Approach households; difference in proportions -1.1% (95% CI -6.7%, 4.5%).","['102 households were enrolled in HOME2, a 12-month, randomized non-inferiority trial', 'Households of Children with Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection ', 'Pediatric index patients with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) SSTI, their household contacts, and pets were enrolled']","['HOME2', 'hygiene education, twice-daily intranasal mupirocin, and daily bleach-water baths', 'Personalized (decolonization performed only by household members who experienced SSTI during the HOME study) or Household (decolonization performed by all household members) approaches']",[],"[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0204945', 'cui_str': 'Hygiene education'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],102.0,0.162972,"RESULTS Non-inferiority of the Personalized Approach was established for the primary outcome 3-month cumulative SSTI: 23 of 212 (10.8%) participants reported SSTI in Household Approach households, while 23 of 236 (9.7%) participants reported SSTI in Personalized Approach households; difference in proportions -1.1% (95% CI -6.7%, 4.5%).","[{'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Hogan', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Katelyn L', 'Initials': 'KL', 'LastName': 'Parrish', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Mork', 'Affiliation': 'Graduate Program in the Biophysical Sciences, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'Boyle', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Muenks', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Ryley M', 'Initials': 'RM', 'LastName': 'Thompson', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Morelli', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hunstad', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Juliane Bubeck', 'Initials': 'JB', 'LastName': 'Wardenburg', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Rzhetsky', 'Affiliation': 'Department of Human Genetics, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Gehlert', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Carey-Ann D', 'Initials': 'CD', 'LastName': 'Burnham', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Fritz', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa752'] 2449,32521015,"An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis.","OBJECTIVE The objective of this study was to investigate whether diacerein has comparable efficacy with celecoxib in pain reduction for treatment in symptomatic knee OA patients. METHODS This randomized double-blind multicentre non-inferiority trial evaluated diacerein vs celecoxib treatment in patients with Kellgren-Lawrence grade 2-3 and pain scoring ≥4 (10-cm VAS). Patients were randomized to 6 months of treatment with diacerein 50 mg (n = 187) once daily for 1 month and twice daily thereafter, or celecoxib 200 mg (n = 193) once daily. The primary outcome was the change in WOMAC pain score (0-50 cm) at 6 months, and the secondary outcomes were WOMAC sub-scores, VAS pain score, and the OMERACT-OARSI responder rate. RESULTS In the per protocol population, the adjusted mean change from baseline in the WOMAC pain score was -11.1 ( 0.9) with diacerein (n = 140) and -11.8 (0.9) with celecoxib (n = 148). The intergroup difference was 0.7 (95% CI: -1.8, 3.2; P = 0.597), meeting the non-inferiority margin. Supportive analysis of the intention-to-treat population gave similar results. Other outcomes showed no significant difference between treatment groups. The incidence of treatment-related adverse events was low and balanced between groups, but a greater incidence of diarrhoea occurred with diacerein (10.2% vs 3.7%). Diarrhoea was considered mild-to-moderate in all but one case with complete resolution. CONCLUSIONS Diacerein was non-inferior to celecoxib in reducing knee OA pain and improving physical function. Diacerein also demonstrated a good safety profile. TRIAL REGISTRATION A multicentre study on the effect of DIacerein on Structure and Symptoms vs Celecoxib in Osteoarthritis is a National Institutes of Health (NCT02688400) and European Clinical Trial Database (2015-002933-23) registered phase III (Canada) or IV (Europe) study.",2020,"The intergroup difference was 0.7 (95% CI: -1.8, 3.2; P = 0.597), meeting the non-inferiority margin.","['knee osteoarthritis', 'patients with Kellgren-Lawrence grade 2-3 and pain scoring ≥4 (10-cm VAS', 'symptomatic knee OA patients']","['Celecoxib', 'diacerein vs celecoxib', 'celecoxib', 'diacerein 50\u2009mg (n\u2009=\u2009187) once daily for 1\u2009month and twice daily thereafter, or celecoxib', 'diacerein', 'DIacerein']","['Diarrhoea', 'pain reduction', 'incidence of treatment-related adverse events', 'diarrhoea', 'WOMAC sub-scores, VAS pain score, and the OMERACT-OARSI responder rate', 'change in WOMAC pain score', 'knee OA pain and improving physical function', 'WOMAC pain score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0057678', 'cui_str': 'diacetylrhein'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.722927,"The intergroup difference was 0.7 (95% CI: -1.8, 3.2; P = 0.597), meeting the non-inferiority margin.","[{'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montréal Hospital Research Centre (CRCHUM), Québec, Canada.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Raynauld', 'Affiliation': 'Institut de Rhumatologie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dorais', 'Affiliation': ""StatSciences Inc., Notre-Dame-de-l'Île-Perrot, Québec, Canada.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Groupe de Recherche en Rhumatologie et Maladies Osseuses, Sainte-Foy, Québec, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilova', 'Affiliation': 'MEDICAL PLUS s.r.o., Uherske Hradiste, Faculty of Pharmacy, Department of Pharmaceutics, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Centre de Recherche Musculosquelettique, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Pavelka', 'Affiliation': 'Institute of Rheumatology and Clinic of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Paiement', 'Affiliation': 'Imaging Research & Development, ArthroLab Inc, Montréal, Québec, Canada.'}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Martel-Pelletier', 'Affiliation': 'Osteoarthritis Research Unit, University of Montréal Hospital Research Centre (CRCHUM), Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa072'] 2450,32521022,Outcomes Comparison Between Wavefront-Optimized and Topography-Guided PRK in Contralateral Eyes With Myopia and Myopic Astigmatism.,"PURPOSE To compare clinical outcomes between topography-guided customized ablation treatment (TCAT) and wavefront-optimized (WFO) photorefractive keratectomy (PRK) in fellow eyes of myopic patients. METHODS Forty-six eyes of 23 patients who underwent PRK were included. WFO ablation was performed in one eye (WFO group) and TCAT in the fellow eye (TCAT group). The customized treatment plan was based on the Topolyzer Vario topography system (Alcon Laboratories, Inc) data. The patients were observed for 12 months after the procedure. RESULTS One year after the surgery, there was no significant difference in the manifest refraction spherical equivalent, sphere, or cylinder variables between the two groups (P > .05). In both groups, 96% of eyes achieved an uncorrected distance visual acuity of 20/20 or better at 12 months postoperatively. Accuracy, safety, and efficacy of the refractive and visual outcomes were similar in the two groups. The postoperative higher order aberrations magnitude was lower in the TCAT group, but this was not statistically significant (P > .05). During the 12-month follow-up, no patient described any symptoms related to glare, halos, or starbursts in either eye. Other postoperative complications, such as infection or cor-neal infiltrates, did not occur in either group. CONCLUSIONS TCAT and WFO ablations provided similar outcomes after PRK for myopia and myopic astigmatism correction. There were no statistically significant differences in postoperative corneal wavefront analysis. [J Refract Surg. 2020;36(6):358-365.].",2020,"The postoperative higher order aberrations magnitude was lower in the TCAT group, but this was not statistically significant (P > .05).","['Contralateral Eyes', 'Forty-six eyes of 23 patients who underwent PRK were included', 'fellow eyes of myopic patients']","['Wavefront-Optimized and Topography-Guided PRK', 'TCAT', 'topography-guided customized ablation treatment (TCAT) and wavefront-optimized (WFO) photorefractive keratectomy (PRK', 'TCAT and WFO ablations']","['WFO ablation', 'Accuracy, safety, and efficacy of the refractive and visual outcomes', 'uncorrected distance visual acuity', 'postoperative corneal wavefront analysis', 'manifest refraction spherical equivalent, sphere, or cylinder variables', 'postoperative complications, such as infection or cor-neal infiltrates', 'postoperative higher order aberrations magnitude']","[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1532953', 'cui_str': 'Wavefront analysis'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",,0.043422,"The postoperative higher order aberrations magnitude was lower in the TCAT group, but this was not statistically significant (P > .05).","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Faria-Correia', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ribeiro', 'Affiliation': ''}, {'ForeName': 'Bernardo T', 'Initials': 'BT', 'LastName': 'Lopes', 'Affiliation': ''}, {'ForeName': 'Marcella Q', 'Initials': 'MQ', 'LastName': 'Salomão', 'Affiliation': ''}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Ambrósio', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20200416-01'] 2451,32521053,Cost-effectiveness of sigmoid resection with primary anastomosis or end colostomy for perforated diverticulitis: an analysis of the randomized Ladies trial.,"BACKGROUND Several studies have been published favouring sigmoidectomy with primary anastomosis over Hartmann's procedure for perforated diverticulitis with purulent or faecal peritonitis (Hinchey grade III or IV), but cost-related outcomes were rarely reported. The present study aimed to evaluate costs and cost-effectiveness within the DIVA arm of the Ladies trial. METHODS This was a cost-effectiveness analysis of the DIVA arm of the multicentre randomized Ladies trial, comparing primary anastomosis over Hartmann's procedure for Hinchey grade III or IV diverticulitis. During 12-month follow-up, data on resource use, indirect costs (Short Form Health and Labour Questionnaire) and quality of life (EuroQol Five Dimensions) were collected prospectively, and analysed according to the modified intention-to-treat principle. Main outcomes were incremental cost-effectiveness (ICER) and cost-utility (ICUR) ratios, expressed as the ratio of incremental costs and the incremental probability of being stoma-free or incremental quality-adjusted life-years respectively. RESULTS Overall, 130 patients were included, of whom 64 were allocated to primary anastomosis (46 and 18 with Hinchey III and IV disease respectively) and 66 to Hartmann's procedure (46 and 20 respectively). Overall mean costs per patient were lower for primary anastomosis (€20 544, 95 per cent c.i. 19 569 to 21 519) than Hartmann's procedure (€28 670, 26 636 to 30 704), with a mean difference of €-8126 (-14 660 to -1592). The ICER was €-39 094 (95 per cent bias-corrected and accelerated (BCa) c.i. -1213 to -116), indicating primary anastomosis to be more cost-effective. The ICUR was €-101 435 (BCa c.i. -1 113 264 to 251 840). CONCLUSION Primary anastomosis is more cost-effective than Hartmann's procedure for perforated diverticulitis with purulent or faecal peritonitis.",2020,"Overall mean costs per patient were lower for primary anastomosis (€20 544, 95 per cent c.i.","[""130 patients were included, of whom 64 were allocated to primary anastomosis (46 and 18 with Hinchey III and IV disease respectively) and 66 to Hartmann's procedure (46 and 20 respectively"", '636 to 30\u2009704), with a mean difference of €-8126', '094', ""primary anastomosis over Hartmann's procedure for Hinchey grade III or IV diverticulitis"", ""19\u2009569 to 21\u2009519) than Hartmann's procedure (€28\u2009670, 26"", '113\u2009264 to 251\u2009840']",['sigmoid resection with primary anastomosis or end colostomy for perforated diverticulitis'],"['Cost-effectiveness', 'resource use, indirect costs (Short Form Health and Labour Questionnaire) and quality of life (EuroQol Five Dimensions', 'incremental cost-effectiveness (ICER) and cost-utility (ICUR) ratios, expressed as the ratio of incremental costs and the incremental probability of being stoma-free or incremental quality-adjusted life-years respectively', 'Overall mean costs per patient', 'costs and cost-effectiveness', 'cost-effective']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C4708913', 'cui_str': '840'}]","[{'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0400074', 'cui_str': 'Construction of end colostomy'}, {'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",130.0,0.166953,"Overall mean costs per patient were lower for primary anastomosis (€20 544, 95 per cent c.i.","[{'ForeName': 'D P V', 'Initials': 'DPV', 'LastName': 'Lambrichts', 'Affiliation': 'Departments of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Amsterdam University Medical Centre, AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Amsterdam University Medical Centre, AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Departments of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}]",The British journal of surgery,['10.1002/bjs.11715'] 2452,32521054,Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery.,"OBJECTIVES To evaluate the efficacy and safety of the Shikani optical stylet (SOS) versus fiberoptic bronchoscope (FOB) for awake nasal intubation in head and neck surgery patients with an anticipated difficult airway. STUDY DESIGN Prospective randomized clinical trial. METHODS This study involved 50 adult patients scheduled for elective head and neck surgery and presented with an anticipated difficult airway. Patients planned for awake nasotracheal intubation were randomly divided into two groups: FOB (n = 25) and SOS (n = 25). Patients were intubated under local anesthesia and sedation using the randomly assigned intubation device by anesthetists proficient in both airway devices. The time to successful intubation was regarded as the primary endpoint. RESULTS The median time (interquartile range) to tracheal intubation in the FOB group was 74 seconds (57-108) and 38 seconds (27-60) in the SOS group (P < .001). Intubation success rates on the first attempt in the FOB and SOS groups were 96% and 92%, respectively (P > .999). Airway assisted maneuvers were required in six (24%) SOS intubations compared to 21 (84%) FOB intubations (P < .001). There were no significant differences between the groups in the incidences of oxygen desaturation and postoperative complications related to intubation. CONCLUSION Compared to the FOB group, awake nasal intubation in the SOS group required significantly less time and fewer airway-assisted maneuvers on adult head and neck surgery patients with anticipated difficult airway. LEVEL OF EVIDENCE 2 Laryngoscope, 2020.",2020,Airway assisted maneuvers were required in six (24%),"['Patients were intubated under', 'awake nasal intubation in head and neck surgery patients with an anticipated difficult airway', 'Patients Undergoing Head and Neck Surgery', '50 adult patients scheduled for elective head and neck surgery and presented with an anticipated difficult airway', 'Patients planned for awake nasotracheal intubation']","['local anesthesia and sedation using the randomly assigned intubation device by anesthetists proficient in both airway devices', 'FOB', 'Shikani Optical Stylet for Awake Nasal Intubation', 'Shikani optical stylet (SOS) versus fiberoptic bronchoscope (FOB']","['oxygen desaturation and postoperative complications', 'median time (interquartile range) to tracheal intubation', 'FOB intubations', 'time to successful intubation', 'Intubation success rates', 'efficacy and safety', 'awake nasal intubation', 'SOS intubations', 'time and fewer airway-assisted maneuvers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",50.0,0.0690683,Airway assisted maneuvers were required in six (24%),"[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Cheng', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Li-Kuan', 'Initials': 'LK', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Hai-Yin', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': ""Department of Anesthesiology, Peking University School and Hospital of Stomatology, Beijing, People's Republic of China.""}]",The Laryngoscope,['10.1002/lary.28763'] 2453,32521096,Comparing Exposure- and Coping Skills-Based Treatments on Trauma-Related Guilt in Veterans with Co-Occurring Alcohol Use and Posttraumatic Stress Disorders.,"Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) commonly co-occur, and this comorbidity (PTSD-SUD) is associated with more severe symptoms and functional impairment than either disorder alone. Growing evidence indicates that trauma-related guilt, typically concerning negative appraisals of one's actions or inaction during a traumatic event, is associated with PTSD, depression, suicidality, and, possibly, substance use. The present study examined whether integrated treatment for PTSD-SUD was effective in reducing trauma-related guilt as measured by the Trauma-Related Guilt Inventory. Data were drawn from a randomized clinical trial comparing the effectiveness of two integrated therapies on treatment outcomes in a sample of U.S. veterans (N = 119) with comorbid PTSD and SUD. Participants were randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE; n = 63) or Seeking Safety (SS; n = 56). The results indicated that global guilt decreased over time for the whole sample. However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498. To our knowledge, this was the first study to examine the effects of integrated PTSD-SUD treatment on trauma-related guilt. The findings highlight that exposure-based, trauma-focused treatment for comorbid PTSD-SUD can be more effective in decreasing trauma-related guilt, with potentially longer-lasting effects, than non-exposure-based treatment, adding evidence that patients with PTSD-SUD should be offered such treatment.",2020,"However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498.","['Veterans with Co-Occurring Alcohol Use and Posttraumatic Stress Disorders', 'a sample of U.S. veterans (N = 119) with comorbid PTSD and SUD']","['integrated PTSD-SUD', 'Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE; n = 63) or Seeking Safety (SS', 'Exposure- and Coping Skills-Based Treatments']","['global guilt', 'rates of global guilt']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",119.0,0.017374,"However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498.","[{'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Capone', 'Affiliation': 'Providence VA Medical Center, Providence, Rhode Island, USA.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': 'James A Haley Veterans Hospital, Tampa, Florida, USA.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22538'] 2454,32521097,Narrative Reconstruction as an Intervention for Posttraumatic Stress Disorder: A Pilot Delayed Intervention Quasi-Randomized Controlled Trial.,"Although empirically supported treatments for posttraumatic stress disorder (PTSD) exist, many patients fail to complete therapy, are nonresponsive, or remain symptomatic following treatment. This paper presents the results of a delayed intervention quasi-randomized controlled study that evaluated the efficacy of narrative reconstruction as an integrative intervention for PTSD. During narrative reconstruction, the patient and therapist reconstruct an organized, coherent, and detailed written narrative of the patient's traumatic experience. Additionally, narrative reconstruction focuses on arriving at the subjective meaning of the traumatic experience for the patient as related to their personal history. Thus, the therapist asks the patient about associations between the traumatic event and other memories and life events. In the present study, 30 participants with PTSD were randomly assigned to an immediate (n = 17) or delayed (n = 13) 15-session narrative reconstruction intervention. Participants in the immediate narrative reconstruction group were evaluated using self-report measures and structured interviews at baseline, posttreatment, and 15-week follow-up. Participants in the delayed narrative reconstruction group were evaluated at baseline, postwaitlist/pretreatment, and posttreatment assessments. Data from the pretreatment evaluation showed no significant differences between groups. Mixed linear models showed significant intervention effects for posttraumatic symptom severity, d = 1.17, from pre- to posttreatment. Although preliminary, these promising findings suggest that narrative reconstruction may be an effective standalone therapy or an add-on to current effective treatment strategies.",2020,"Mixed linear models showed significant intervention effects for posttraumatic symptom severity, d = 1.17, from pre- to posttreatment.","['Posttraumatic Stress Disorder', '30 participants with PTSD were randomly assigned to an immediate (n = 17) or delayed (n = 13']","['Narrative Reconstruction', 'narrative reconstruction', '15-session narrative reconstruction intervention']",[],"[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],30.0,0.0173915,"Mixed linear models showed significant intervention effects for posttraumatic symptom severity, d = 1.17, from pre- to posttreatment.","[{'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Gofman', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Bar-Kalifa', 'Affiliation': 'Psychology Department, Ben Gurion University, Beersheba, Israel.'}, {'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Vidan', 'Affiliation': 'Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Hasson Ohayon', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Rivka', 'Initials': 'R', 'LastName': 'Tuval-Mashiach', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Tuvia', 'Initials': 'T', 'LastName': 'Peri', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat Gan, Israel.'}]",Journal of traumatic stress,['10.1002/jts.22537'] 2455,32521100,Social Support Moderates the Association Between Posttraumatic Stress Disorder Treatment Duration and Treatment Outcomes in Telemedicine-Based Treatment Among Rural Veterans.,"For patients participating in trauma-focused psychotherapies for posttraumatic stress disorder (PTSD), such as cognitive processing therapy (CPT), pretreatment characteristics may moderate treatment effectiveness. For instance, preexisting supportive relationships may encourage skill utilization or provide contrasts to maladaptive cognitive biases highlighted in trauma-focused treatments for PTSD. Such pretreatment characteristics are important to study in rural individuals, who may experience barriers to initiating and completing treatment. The aim of this study was to examine whether pretreatment social support, measured using the Medical Outcomes Study Social Support Survey, would moderate the association between CPT duration (i.e., number of sessions attended) and change in PTSD symptoms, using data from a pragmatic randomized controlled trial of a telemedicine-based collaborative care intervention for rural veterans (N = 225). Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support. This effect was found for overall and emotional support but not tangible support. Additionally, on average, among participants who attended eight or more CPT sessions, only those at or above 1 standard deviation above the mean social support score demonstrated a reliable change in PTSD symptoms. The results indicate that the link between CPT treatment duration and treatment outcomes may be stronger for veterans with higher levels of pretreatment social support.",2020,"Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support.","['Rural Veterans', 'rural veterans (N = 225', 'patients participating in trauma-focused psychotherapies for posttraumatic stress disorder (PTSD', 'rural individuals']","['cognitive processing therapy (CPT', 'CPT', 'telemedicine-based collaborative care intervention']","['PTSD symptoms', 'CPT duration and PTSD symptom change', 'PTSD symptom change']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",225.0,0.0143797,"Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support.","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Minneapolis VA Health Care System, Center for Chronic Disease Outcomes Research, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Grubbs', 'Affiliation': 'VA San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fortney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22542'] 2456,32521115,Randomized Comparison of Techniques for Control of the Dorsal Venous Complex During Robotic-assisted Laparoscopic Radical Prostatectomy.,"OBJECTIVE To prospectively compare the effects of endoscopic stapling, division and suture ligation, and suture ligation with suspension of the dorsal venous complex (DVC) on continence during RARP PATIENTS AND METHODS: 300 consecutive patients undergoing RARP by a single surgeon were randomized to three groups: endoscopic stapling, cut and suture ligation, and suture ligation with suspension. The only difference between the groups was the technique to control the DVC. Pad-free continence (PFC) and overall continence (0 pads/day with or without security pad) was assessed with patient reported pad usage records and validated questionnaires (EPIC) at 3, 12, and 15 months. Secondary endpoints were erectile function recovery (defined as erections sufficient for sexual activity) and the rate of apical surgical margins. Univariate and multivariate analyses were conducted to determine predictors for recovery of both urinary continence and erectile function. RESULTS The three groups were comparable in terms of age, BMI, prostate size, AUA symptom score, SHIM, and clinical stage. There were no differences found in terms of operative times, EBL, pathological stage, and positive apical margin. There was no difference between the three groups with regard to overall continence or pad-fee continence at 3 months. However, overall continence at 15 months for ligation and suspension was 99% and was superior to stapler (88%) (p=0.002) and cut and suture ligation (88%) (p=0.002). Additionally, pad-free continence at 15 months was superior for ligation and suspension (87%) as compared to stapler (73%) and cut and suture ligation (75%) (p=0.045). The technique of DVC control did not impact erectile function. Men with nerve sparing had better continence compared to no nerve sparing at 3 months (62 vs 42%, p=0.045) but not at 15 months. Median time to continence was 2 months for patients receiving nerve sparing compared to 4.5 months for non-nerve sparing (p=0.02). CONCLUSION Suture suspension of the DVC during RARP contributes to higher overall continence rates compared to stapling and cut and sew. Nerve sparing contributes to earlier return of continence than non-nerve sparing.",2020,There was no difference between the three groups with regard to overall continence or pad-fee continence at 3 months.,[' 300 consecutive patients undergoing RARP by a single surgeon'],"['endoscopic stapling, division and suture ligation, and suture ligation with suspension of the dorsal venous complex (DVC', 'Robotic-assisted Laparoscopic Radical Prostatectomy', 'endoscopic stapling, cut and suture ligation, and suture ligation with suspension']","['overall continence or pad-fee continence', 'operative times, EBL, pathological stage, and positive apical margin', 'Median time to continence', 'age, BMI, prostate size, AUA symptom score, SHIM, and clinical stage', 'overall continence', 'overall continence rates', 'Pad-free continence (PFC) and overall continence', 'erectile function recovery (defined as erections sufficient for sexual activity) and the rate of apical surgical margins', 'pad-free continence']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0185016', 'cui_str': 'Suture ligation'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0426731', 'cui_str': 'Prostate size'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0142223', 'cui_str': 'SHIMS'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}]",300.0,0.0246818,There was no difference between the three groups with regard to overall continence or pad-fee continence at 3 months.,"[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Heulitt', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}, {'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}, {'ForeName': 'Hsin-Fang', 'Initials': 'HF', 'LastName': 'Li', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Porter', 'Affiliation': 'Swedish Medical Center, Department of Urology, Seattle, WA.'}]",BJU international,['10.1111/bju.15133'] 2457,32521121,Cinematic Rendering in Anatomy: A Crossover Study Comparing a Novel 3D Reconstruction Technique to Conventional Computed Tomography.,"Integration of medical imaging into preclinical anatomy courses is already underway in many medical schools. However, interpretation of two-dimensional grey scale images is difficult and conventional volume rendering techniques provide only images of limited quality. In this regard, a more photorealistic visualization provided by Cinematic Rendering (CR) may be more suitable for anatomical education. A randomized, two-period crossover study was conducted from July to December 2018, at the University Hospital of Erlangen, Germany to compare CR and conventional computed tomography (CT) imaging for speed and comprehension of anatomy. Sixteen students were randomized into two assessment sequences. During each assessment period, participants had to answer 15 anatomy-related questions that were divided into three categories: parenchymal, musculoskeletal and vascular anatomy. After a washout period of 14 days, assessments were crossed over to the respective second reconstruction technique. The mean interperiod differences for the time to answer differed significantly between the CR-CT sequence (-204.21 ± 156.0 seconds) and the CT-CR sequence (243.33 ± 113.83 seconds; P < 0.001). Overall time reduction by CR was 65.56%. Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001). No carryover effects were observed. A questionnaire revealed that students consider CR to be beneficial for medical education. These results suggest that CR has a potential to enhance knowledge acquisition and transfer from medical imaging data in medical education.",2020,"Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001).","['July to December 2018, at the University Hospital of Erlangen, Germany to compare CR and conventional computed tomography (CT) imaging for speed and comprehension of anatomy', 'Cinematic Rendering in Anatomy', 'participants had to answer 15 anatomy-related questions that were divided into three categories: parenchymal, musculoskeletal and vascular anatomy', 'Sixteen students']",['Novel 3D Reconstruction Technique to Conventional Computed Tomography'],"['Cinematic Rendering visualization of musculoskeletal and vascular anatomy', 'carryover effects', 'CT visualization of parenchymal anatomy']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",16.0,0.0209936,"Cinematic Rendering visualization of musculoskeletal and vascular anatomy was higher rated compared to CT visualization (P < 0.001 and P = 0.003), whereas CT visualization of parenchymal anatomy received a higher scoring than CR visualization (P < 0.001).","[{'ForeName': 'Johannes S', 'Initials': 'JS', 'LastName': 'Binder', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Institut für Funktionelle und Klinische Anatomie, Friedrich-Alexander-Universtät Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ellmann', 'Affiliation': 'Institut für Radiologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Institut für Radiologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}]",Anatomical sciences education,['10.1002/ase.1989'] 2458,32513289,"The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial.","OBJECTIVES The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment. The secondary objectives are: 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment.2.To assess the efficacy of ivermectin to improve symptom progression in treated patients.3.To assess the proportion of seroconversions in treated patients at day 21.4.To assess the safety of ivermectin at the proposed dose.5.To determine the magnitude of immune response against SARS-CoV-2.6.To assess the early kinetics of immunity against SARS-CoV-2. TRIAL DESIGN SAINT is a single centre, double-blind, randomized, placebo-controlled, superiority trial with two parallel arms. Participants will be randomized to receive a single dose of 400 μg/kg ivermectin or placebo, and the number of patients in the treatment and placebo groups will be the same (1:1 ratio). PARTICIPANTS The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity. Vulnerable populations such as pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old) will be excluded. Inclusion criteria 1. Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR. 2. Residents of the Pamplona basin (""Cuenca de Pamplona""). 3. The patient must be between the ages of 18 and 60 years of age. 4. Negative pregnancy test for women of child bearing age*. 5. The patient or his/her representative, has given informed consent to participate in the study. 6. The patient should, in the PI's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation). Exclusion criteria 1. Known history of ivermectin allergy. 2. Hypersensitivity to any component of ivermectin. 3. COVID-19 pneumonia. Diagnosed by the attending physician.Identified in a chest X-ray. 4. Fever or cough present for more than 48 hours. 5. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 6. Age under 18 or over 60 years. 7. The following co-morbidities (or any other disease that might interfere with the study in the eyes of the PI): Immunosuppression.Chronic Obstructive Pulmonary Disease.Diabetes.Hypertension.Obesity.Acute or chronic renal failure.History of coronary disease.History of cerebrovascular disease.Current neoplasm. 8. Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan). 9. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin. *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study). The trial is currently planned at a single center, Clínica Universidad de Navarra, in Navarra (Spain), and the immunology samples will be analyzed at the Barcelona Institute for Global Health (ISGlobal), in Barcelona (Spain). Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN. They will remain in the trial for a period of 28 days at their homes since they will be patients with mild disease. In the interest of public health and to contain transmission of infection, follow-up visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members. Home visits will assess clinical and laboratory parameters of the patients. INTERVENTION AND COMPARATOR Ivermectin will be administered to the treatment group at a 400μg/Kg dose (included in the EU approved label of Stromectol and Scabioral). The control group will receive placebo. There is no current data on the efficacy of ivermectin against the virus in vivo, therefore the use of placebo in the control group is ethically justified. MAIN OUTCOMES Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28. RANDOMISATION Eligible patients will be allocated in a 1:1 ratio using a randomization list generated by the trial statistician using blocks of four to ensure balance between the groups. A study identification code with the format ""SAINT-##"" (##: from 01 to 24) will be generated using a sequence of random numbers so that the randomization number does not match the subject identifier. The sequence and code used will be kept in an encrypted file accessible only to the trial statistician. A physical copy will be kept in a locked cabinet at the CUN, accessible only to the person administering the drug who will not enrol or attend to patient care. A separate set of 24 envelopes for emergency unblinding will be kept in the study file. BLINDING (MASKING) The clinical trial team and the patients will be blinded. The placebo will not be visibly identical, but it will be administered by staff not involved in the clinical care or participant follow up. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The sample size is 24 patients: 12 participants will be randomised to the treatment group and 12 participants to the control group. TRIAL STATUS Current protocol version: 1.0 dated 16 of April 2020. Recruitment is envisioned to begin by May 14th and end by June 14th. TRIAL REGISTRATION EudraCT number: 2020-001474-29, registered April 1 st . Clinicaltrials.gov: submitted, pending number FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28","['2020-001474-29, registered April 1 st ', 'Acute or chronic renal failure', 'women of child bearing age*. 5', 'The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity', 'pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old', 'low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset', '24 patients: 12 participants', 'patients with mild disease', 'Chronic Obstructive Pulmonary Disease', 'Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN', 'Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR', 'Residents of the Pamplona basin (""Cuenca de Pamplona', 'Age under 18 or over 60 years']","['ivermectin', 'Ivermectin', 'quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat', 'ivermectin or placebo', 'placebo']","['fever and cough', 'SARS-CoV-2 viral load', 'positive SARS-CoV-2 PCR', 'PCR cycle threshold (Ct', 'symptom progression', 'IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels', 'Negative pregnancy test', 'Fever or cough', 'severe disease or death']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0179226', 'cui_str': 'Basin'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0376637', 'cui_str': 'Indinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",12.0,0.246002,"Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chaccour', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain. carlos.chaccour@isglobal.org.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ruiz-Castillo', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Richardson', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Aina', 'Initials': 'A', 'LastName': 'Casellas', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carmona-Torre', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Giráldez', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juana Schwartz', 'Initials': 'JS', 'LastName': 'Mota', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Yuste', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Azanza', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Reina', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brew', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Sadaba', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hammann', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Rabinovich', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}]",Trials,['10.1186/s13063-020-04421-z'] 2459,32513307,Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study.,"BACKGROUND Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women's personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful. METHODS/DESIGN A randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decision-making and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study. DISCUSSION The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. TRIAL REGISTRATION {2A}: DRKS-ID: DRKS00015527. Registered 30 October 2019.",2020,"Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept.","['398 women', 'healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers']","['usual care with structured decision support alongside usual care', 'nurse-led decision-coaching program']","['knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept', 'congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0646838,"Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Isselhard', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany. anna.isselhard@uk-koeln.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Töpper', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vitinius', 'Affiliation': 'Department of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beifus', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wiedemann', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schmutzler', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-020-04431-x'] 2460,32513308,Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING) The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","['hospitalized patients with COVID-19', 'patients hospitalized with severe COVID-19 used a similar ordinal scale', 'severely ill adults with COVID-19', 'Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6', 'enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm', 'hospitalized adults with severe SARS-CoV-2 infection', 'Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so', 'Columbia University Irving Medical Center in New York, USA']","['lopinavir- ritonavir', 'possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO', 'human anti-SARS-CoV-2 convalescent plasma', 'anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform', 'anti-SARS-CoV-2 plasma versus one unit']","['efficacy and safety', 'time to clinical improvement', 'Death', 'cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.269262,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberg', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04422-y'] 2461,32513312,Dietary supplementation with seed oil from transgenic Camelina sativa induces similar increments in plasma and erythrocyte docosahexaenoic acid and eicosapentaenoic acid to fish oil in healthy humans.,"EPA and DHA are required for normal cell function and can also induce health benefits. Oily fish are the main source of EPA and DHA for human consumption. However, food choices and concerns about the sustainability of marine fish stocks limit the effectiveness of dietary recommendations for EPA+DHA intakes. Seed oils from transgenic plants that contain EPA+DHA are a potential alternative source of EPA and DHA. The present study investigated whether dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA was as effective as fish oil (FO) in increasing EPA and DHA concentrations when consumed as a dietary supplement in a blinded crossover study. Healthy men and women (n 31; age 53 (20-74) yrs) were randomised to consume 450 mg/day EPA+DHA provided either as either CSO or FO for 8 weeks, followed by 6 weeks washout and then switched to consuming the other test oil. Fasting venous blood samples were collected at the start and end of each supplementation period. Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters. There were no significant differences between test oils in the increments of EPA and DHA. There was no significant difference between test oils in the increase in the proportion of erythrocyte EPA+DHA (CSO, 12%; P < 0.0001 and FO, 8%; P = 0.02). Together these findings show that consuming CSO is as effective as FO for increasing EPA and DHA concentrations in humans.",2020,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","['healthy humans', 'Healthy men and women (n 31; age 53 (20-74) yrs']","['dietary supplementation with transgenic Camelina sativa seed oil (CSO) that contained EPA and DHA', 'consume 450 mg/day EPA+DHA provided either as either CSO or FO']","['EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters', 'EPA and DHA', 'proportion of erythrocyte EPA+DHA', 'Fasting venous blood samples']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0003069', 'cui_str': 'Transgenic Animals'}, {'cui': 'C3474157', 'cui_str': 'CAMELINA SATIVA SEED OIL'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",,0.0929784,"Consuming the test oils significantly (P < 0.05) increased EPA and DHA concentrations in plasma triacylglycerol, phosphatidylcholine and cholesteryl esters.","[{'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'West', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Miles', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Centre for Biological Sciences, Faculty of Natural and Environmental Sciences, University of Southampton, SouthamptonSO17 1BJ, UK.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Johnathan A', 'Initials': 'JA', 'LastName': 'Napier', 'Affiliation': 'Department of Plant Sciences, Rothamsted Research, HarpendenAL5 2JQ, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002044'] 2462,32513313,Dried fruit consumption and cardiometabolic health: a randomized crossover trial.,"Fruit intake is associated with lower risk of cardiometabolic diseases. However, effects of dried fruits on cardiometabolic health are not well researched. We investigated the effect of daily dried fruit consumption compared to a carbohydrate-rich snack on cardiometabolic disease risk factors in adults with increased cardiometabolic risk. A two-period randomized crossover trial was conducted in adults (n=55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup/d mixed dried fruits (plums, figs, dates, and raisins) or a calorie- and carbohydrate-matched control snack for 4 weeks. The primary outcome was low-density lipoprotein cholesterol (LDL-C); secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure, and vascular stiffness. Linear mixed models were used for data analysis. Lipid and lipoprotein concentrations did not differ between conditions, however dried fruit increased LDL-C (0.10 mmol/L, 95% CI: 0.01, 0.20) compared to baseline. Compared to the control, dried fruit increased mean fasting glucose (0.08 mmol/L, 95% CI: 0.005, 0.16; P=0.038). Vascular outcomes, fasting insulin, and C-reactive protein did not differ between conditions. Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75). Thus, short-term daily consumption of a large portion of mixed dried plums, figs, dates, and raisins, without structured dietary guidance, did not improve cardiometabolic risk factors, compared to carbohydrate-rich snacks, in adults with increased baseline cardiometabolic risk.",2020,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","['adults (n=55) with elevated BMI and at least one additional risk factor for cardiometabolic disease to compare the effects of consuming 3/4 cup', 'adults with increased cardiometabolic risk']","['dried fruits', 'daily dried fruit consumption', 'carbohydrate-rich snack', 'd mixed dried fruits (plums, figs, dates, and raisins) or a calorie- and carbohydrate-matched control snack']","['Dried fruit consumption and cardiometabolic health', 'cardiometabolic health', 'mean fasting glucose', 'Vascular outcomes, fasting insulin, and C-reactive protein', 'baseline cardiometabolic risk', 'Lipid and lipoprotein concentrations', 'Mean weight changes', 'cardiometabolic risk factors', 'low-density lipoprotein cholesterol (LDL-C); secondary outcomes included other lipids and lipoproteins, glucose and insulin, C-reactive protein, blood pressure, and vascular stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0349966', 'cui_str': 'Figs'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0453296', 'cui_str': 'Dried fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0916874,"Mean weight changes did not differ (P=0.55) but tended to increase after both conditions (dried fruit: 0.3 kg, 95% CI: -0.09, 0.65; control: 0.4 kg, 95% CI: 0.01, 0.75).","[{'ForeName': 'Valerie K', 'Initials': 'VK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Nutritional Sciences, 110 Chandlee Laboratory, The Pennsylvania State University, University Park, PA16802.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, 110 Chandlee Laboratory, The Pennsylvania State University, University Park, PA16802.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, 110 Chandlee Laboratory, The Pennsylvania State University, University Park, PA16802.'}]",The British journal of nutrition,['10.1017/S0007114520002007'] 2463,32513317,Cracker shape modifies ad libitum snack intake of crackers with cheese dip.,"Food and energy intake can be effectively lowered by changing food properties, but little is known whether modifying food shape is sufficient to influence intake. This study investigated the influence of cracker shape and cheese viscosity on ad libitum intake of cracker-cheese combinations. Forty-four participants (13 males, 23±3 years, BMI 21±2 kg/m2) participated in four late afternoon snack sessions [2x2 randomized crossover design]. Iso-caloric crackers were baked into flat squares and finger-shape cylindrical sticks and combined with a cheese dip varying in viscosity. Approximately 80 crackers and 500 g cheese dip were served in separate large bowls. Participants consumed crackers with cheese dip ad libitum while watching a movie of 30 minutes. Dipping behaviour and oral processing behaviour were measured simultaneously by hidden balances under the cheese bowls and video recordings. Cracker intake (28±1 crackers) of cracker-cheese combinations was not influenced by cracker shape. Cheese intake of cracker-cheese combinations was 15% higher for flat squared than finger-shape crackers (131 kJ, p=0.016), as a larger amount of cheese was scooped with flat squared crackers (2.9±0.2 vs. 2.3±0.1 g cheese per dip, p<0.001), and showed higher eating rate and energy intake rate (p<0.001). Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12). Larger energy intake from condiments was facilitated by increased cracker surface, and this did not trigger earlier satiation. Changing food carrier surface may be a promising approach to moderate energy intake of often high energy dense condiments, sauces and toppings.",2020,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"['crackers with cheese dip', 'Forty-four participants (13 males, 23±3 years, BMI 21±2 kg/m2) participated in four late afternoon snack sessions [2x2 randomized crossover design']",[],"['Eating rate over snacking time', 'Dipping behaviour and oral processing behaviour', 'eating rate and energy intake rate', 'Cheese intake of cracker-cheese combinations', 'bite frequency']","[{'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]",[],"[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0585041', 'cui_str': 'Snack time'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0556187', 'cui_str': 'Cheese intake'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",44.0,0.0651299,Eating rate over snacking time decreased by reducing bite frequency (p<0.001) while cheese dip size remained fairly constant (p=0.12).,"[{'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'van Eck', 'Affiliation': 'TiFN, P.O. Box 557, 6700 AN Wageningen, The Netherlands.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'van Stratum', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700 AA Wageningen, The Netherlands.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Achlada', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700 AA Wageningen, The Netherlands.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Goldschmidt', 'Affiliation': ""BEL group, Structure-Function Research 7- bd de l'Industrie - BP40077 41102 VENDÔME CEDEX, France.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Scholten', 'Affiliation': 'TiFN, P.O. Box 557, 6700 AN Wageningen, The Netherlands.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Fogliano', 'Affiliation': 'TiFN, P.O. Box 557, 6700 AN Wageningen, The Netherlands.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'TiFN, P.O. Box 557, 6700 AN Wageningen, The Netherlands.'}, {'ForeName': 'Dieuwerke', 'Initials': 'D', 'LastName': 'Bolhuis', 'Affiliation': 'Food Quality and Design, Wageningen University, P.O. Box 17, 6700 AA Wageningen, The Netherlands.'}]",The British journal of nutrition,['10.1017/S0007114520002056'] 2464,32513334,The effect of 12 weeks of equicaloric high protein diet in regulating appetite and body composition of women with Normal Weight Obesity: a randomized controlled trial.,"Normal weight obesity (NWO) syndrome is associated with metabolic diseases. The present study aimed to investigate the effects of 12 weeks of a high-protein (HP) versus a standard protein (SP) diet on appetite, anthropometry, and body composition in NWO women. In this clinical trial, 50 NWO women were randomly allocated to an HP (n=25) or an SP (n=25) diet groups. Women in the HP and SP groups consumed 25% and 15% of their total energy intake from protein for 12 weeks. Weight, fat mass (FM), lean body mass (LBM), waist circumference (WC), and appetite were evaluated at baseline and following their three-month intervention. After 12 weeks, the LBM was higher in HP compared to no significant changes in the SP group [mean between-group difference= 1.5 kg (95% confidence interval {CI}, 3.1 to 0.01, effect size {d}= 0.4)]. Furthermore, the HP group had lower FM [mean between-group difference, -1.1 kg (95% CI, 1 to -3.3; d= -0.2)], body fat percentage (BFP) [mean between-group difference, -2 % (95% CI, 0.7 to -5.2; d= -0.3)] and WC [mean between-group difference, -1.4 cm (95% CI, 0.6 to -3.6; d= -0.2)] at the end of the study in comparison to the SP group. In both groups, weight and appetite were unchanged over time without significant differences between groups. 12 weeks of eucaloric diets with different dietary protein content resulted in no significant weight loss in women with NWO. However, an HP diet significantly improved body composition (LBM, FM, BFP, and WC) in this population.",2020,12 weeks of eucaloric diets with different dietary protein content resulted in no significant weight loss in women with NWO.,"['50 NWO women', 'women with NWO', 'women with Normal Weight Obesity', 'NWO women']","['HP diet', 'HP', 'SP', 'equicaloric high protein diet', 'high-protein (HP) versus a standard protein (SP) diet']","['body composition (LBM, FM, BFP, and WC', 'Normal weight obesity (NWO) syndrome', 'weight and appetite', 'weight loss', 'LBM', 'body fat percentage (BFP', 'appetite and body composition', 'FM', 'Weight, fat mass (FM), lean body mass (LBM), waist circumference (WC), and appetite']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0045933', 'cui_str': '2-benzyl-3-formylpropanoic acid'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",50.0,0.102932,12 weeks of eucaloric diets with different dietary protein content resulted in no significant weight loss in women with NWO.,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haghighat', 'Affiliation': 'Laparascopy Research Center, School of medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mahmoodi', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Majdadin', 'Initials': 'M', 'LastName': 'Rajaei', 'Affiliation': 'Department of Radiotherapy and Oncology, School of medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Alipour', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Kooti', 'Affiliation': 'Lung Diseases & Allergy Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammdi', 'Affiliation': 'Department of Nutrition, Khalkhal University of Medical Sciences, Khalkhal, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, United States.'}]",The British journal of nutrition,['10.1017/S0007114520002019'] 2465,32513359,Glycerol Preserved Amnion: A Viable Source of Biological Dressing for Superficial Partial Thickness Facial Burns.,"OBJECTIVES To evaluate the role of amnion as a biological dressing in superficial partial thickness facial burns. STUDY DESIGN Randomized controlled trial. PLACE AND DURATION OF STUDY Jinnah Burn and Reconstructive Surgery Centre, Lahore, from January 2017 to December 2018. METHODS Sixty two patients with superficial partial thickness facial burns were randomly divided into two groups (A and B). Ointment containing Polymyxin B and Bacitracin was applied in group A (n=28) while amnion was applied in group B (n=34). The patients were monitored for the pain related to burns needing analgesia, time of healing of burns, and cosmetic outcome of the facial scarring over a period of six months. RESULTS The mean age of the patients was 26.5 ±12.2 years. 39 (62.9%) patients were male and 23 (37.1%) were females. The mean percent total facial surface area burned was 2.7% ±1. None of the patients developed facial wound infections. The average healing time was 6 ±2 days. The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups. No significant difference was observed in VAS score at 1, 3 and 6 month follow up between both groups. CONCLUSION Amnion is a safe, cost effective and most readily available biological dressing for superficial partial thickness facial burn management. Key Words: Amnion, Facial burn, Biological dressing, Scarring, Partial thickness burn.",2020,The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups.,"['superficial partial thickness facial burns', 'patients were male and 23 (37.1%) were females', 'Sixty two patients with superficial partial thickness facial burns', 'Jinnah Burn and Reconstructive Surgery Centre, Lahore, from January 2017 to December 2018', 'Superficial Partial Thickness Facial Burns']","['Biological Dressing', 'Glycerol Preserved Amnion', 'Polymyxin B and Bacitracin']","['mean percent total facial surface area burned', 'VAS score', 'average healing time', 'infection rate', 'pain related to burns needing analgesia, time of healing of burns, and cosmetic outcome of the facial scarring', 'mean frequency of analgesia', 'facial wound infections']","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness'}, {'cui': 'C0433163', 'cui_str': 'Burn of face'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005513', 'cui_str': 'Dressing, Biological'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}]",62.0,0.0146394,The mean frequency of analgesia for 3 days of group B was less as compared to group A. infection rate was similar in both groups.,"[{'ForeName': 'Muhammad Umar', 'Initials': 'MU', 'LastName': 'Asif', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Farrukh Aslam', 'Initials': 'FA', 'LastName': 'Khalid', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Ilyas', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Moazzam Nazeer', 'Initials': 'MN', 'LastName': 'Tarar', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Zain Ul', 'Initials': 'ZU', 'LastName': 'Abidin', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Sheraz', 'Initials': 'MS', 'LastName': 'Raza', 'Affiliation': 'Department of Plastic Surgery, Jinnah Burn and Reconstructive Surgery Center, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.04.394'] 2466,32513495,Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture.,"PURPOSE Current treatment guidelines recommend treatment for postmenopausal women with a T score <2.5 regardless of age. This subgroup analysis evaluated the efficacy and safety of abaloparatide in younger postmenopausal women considered to be at high risk for fracture. METHODS Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization). FINDINGS A total of 296 women (age range, 49-64 years) were included. Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites). Fracture rates were numerically lower for abaloparatide versus placebo, consistent with the overall trial results, although the differences were not statistically significant. The number needed to treat to prevent 1 additional vertebral fracture after 18 months of treatment versus placebo was 18 for abaloparatide and 21 for teriparatide. The number needed to treat had nonsignificant trends toward lower values with abaloparatide versus teriparatide for nonvertebral fractures (23 vs 40) and clinical fractures (16 vs 73) and similar for major osteoporotic fractures (24 vs 27). The safety profile was consistent with the overall ACTIVE population. IMPLICATIONS Findings of this subgroup (post hoc) analysis are consistent with the overall ACTIVE population. Abaloparatide appears to be effective and well tolerated in this subgroup of younger postmenopausal women. ClinicalTrials.gov identifier: NCT01343004.",2020,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","['Women with Osteoporosis at High Risk for Fracture', 'postmenopausal women with a T score <2.5 regardless of age', 'Younger Postmenopausal', 'younger postmenopausal women', 'Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization', '296 women (age range, 49-64 years) were included']","['placebo', 'teriparatide', 'abaloparatide versus teriparatide', 'Abaloparatide']","['bone mineral density', 'Fracture rates', 'clinical fractures', 'number needed to treat to prevent 1 additional vertebral fracture', 'Bone Mineral Density and Fracture Incidence', 'major osteoporotic fractures', 'efficacy and safety of abaloparatide', 'nonvertebral fractures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]",296.0,0.32921,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","[{'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Setareh A', 'Initials': 'SA', 'LastName': 'Williams', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Weiss', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA. Electronic address: rweiss@radiuspharm.com.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.012'] 2467,32513518,Combinatorial PharmacogenomicTesting Improves Outcomes for Older Adults With Depression.,"OBJECTIVE Evaluate the clinical utility of combinatorial pharmacogenomic testing for informing medication selection among older adults who have experienced antidepressant medication failure for major depressive disorder (MDD). DESIGN Post hoc analysis of data from a blinded, randomized controlled trial comparing two active treatment arms. SETTING Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites. PARTICIPANTS Adults age 65 years or older at baseline (n = 206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode. INTERVENTION Combinatorial pharmacogenomic testing to inform medication selection (guided-care), compared with treatment as usual (TAU). OUTCOMES Mean percent symptom improvement, response rate, and remission rateat week 8, measured using the 17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis. RESULTS At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU. By week 8, more than twice as many patients in guided-care than in TAU were on medications predicted to have no gene-drug interactions (χ 2  = 19.3, df = 2; p <0.001). Outcomes in the guided-care arm showed consistent improvement through the end of the open-design 24-week trial, indicating durability of the effect. Differences in outcomes between arms were not significantly impacted by comorbidities. CONCLUSIONS Combinatorial pharmacogenomic test-informed medication selection improved outcomes over TAU among older adults with depression.",2020,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","['older adults with depression', 'older adults who have experienced antidepressant medication failure for major depressive disorder (MDD', 'Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites', 'Older Adults With Depression', 'Adults age 65 years or older at baseline (n\u202f=\u202f206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode']","['combinatorial pharmacogenomic testing', 'Combinatorial PharmacogenomicTesting']","['Mean percent symptom improvement, response rate, and remission rateat', 'symptom improvement', '17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis', 'remission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0861888,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","[{'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA. Electronic address: bforester@mclean.harvard.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weisenbach', 'Affiliation': 'Stony Brook University, Department of Psychiatry & Behavioral Health (SW), Stony Brook, NY.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'University of Illinois at Chicago, School of Public Health/Psychiatric Institute (OJ), Chicago, IL.'}, {'ForeName': 'Ipsit', 'Initials': 'I', 'LastName': 'Vahia', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare (AJR), Worcester, MA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, the Corporal Michael Crescenz VAMC (MET), Philadelphia, PA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences (BWD), Atlanta, GA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences (CDB), Stanford, CA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Washington University School of Medicine, Department of Psychiatry, and the John Cochran Veteran's Administration Hospital (CRC), St. Louis, MO.""}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychiatry and School of Medicine (RCS), Birmingham, AL.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Psychiatry and Behavioral Sciences (MM), Wichita, KS.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Traxler', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dechairo', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.005'] 2468,32513562,Maternal mental health and partner-delivered massage: A pilot study.,"BACKGROUND Anxiety and depression affects many pregnant women. Massage may be beneficial for supporting mental wellbeing during this time. The aim of this study was to assess the feasibility and acceptability of a partner-delivered relaxation massage program for pregnant women, and its impact on symptoms of antenatal anxiety, stress and depression. METHODS A feasibility randomised controlled trial was conducted to compare partner-delivered relaxation massage (intervention) with self-directed stress management (control). Women attended an initial workshop at 28-32 weeks gestation followed by completion of a self-directed massage or stress management program. Qualitative data about the feasibility and acceptability (primary outcomes) were collected via online participant diaries and post-birth interviews. Anxiety, depression and stress symptoms (secondary outcomes) were assessed using the Depression and Anxiety Stress Scale (DASS-21). Birth outcomes were collected at the post- birth interview. RESULTS A total of 14 women/partner dyads in the massage group and 13 women in the self-directed stress management group, attended the initial workshops. When interviewed, participants from both groups reported that the programs were feasible and acceptable. Women's mean scores on all subscales of the DASS-21significantly decreased over time in both the intervention and the control group. CONCLUSION Pregnant women found the partner-delivered massage program to be feasible and acceptable. Both programs decreased women's symptoms of anxiety, depression and stress with no significant differences identified between the two groups. An adequately powered experimental study with a large representative sample is needed to determine whether partner-delivered relaxation massage reduces pregnant women's symptoms of anxiety, depression and stress.",2020,"Women's mean scores on all subscales of the DASS-21significantly decreased over time in both the intervention and the control group. ","['14 women/partner dyads in the massage group and 13 women in the self-directed stress management group, attended the initial workshops', 'Pregnant women found the partner-delivered', 'pregnant women']","['Maternal mental health and partner-delivered massage', 'partner-delivered relaxation massage program', 'relaxation massage', 'Massage', 'massage program', 'partner-delivered relaxation massage (intervention) with self-directed stress management (control', 'self-directed massage or stress management program']","['feasibility and acceptability', 'Anxiety, depression and stress symptoms', ""women's symptoms of anxiety, depression and stress"", 'Depression and Anxiety Stress Scale (DASS-21']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]",14.0,0.0381907,"Women's mean scores on all subscales of the DASS-21significantly decreased over time in both the intervention and the control group. ","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hall', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia; Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia. Electronic address: helen.hall@monash.edu.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Munk', 'Affiliation': 'Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia; Indiana University School of Health & Human Sciences, IUPUI, Indianapolis, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fogarty', 'Affiliation': 'Western Sydney University, School of Medicine, Penrith NSW, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Cant', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Holton', 'Affiliation': 'School of Nursing and Midwifery, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Weller', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Lauche', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia; Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia; Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany; National Centre in Naturopathic Medicine, Southern Cross University, Lismore NSW, Australia.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2020.05.003'] 2469,32513581,Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients.,"BACKGROUND AND AIM Lipid abnormalities are common in peritoneal dialysis (PD) patients and no effective treatment to decrease serum lipoprotein (a) [Lp(a)] in dialysis patients is known so far. Therefore, this research was designed to investigate the effects of soy isoflavone supplement on serum lipids and Lp(a) in PD patients. METHODS & RESULTS In this randomized, double-blind, placebo-controlled trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The patients in the isoflavone group received 100 mg soy isoflavone daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of the 8th week, 7 mL of blood was obtained from each patient and serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a) were measured. Serum Lp(a) reduced significantly up to 10% in the isoflavone group at the end of week 8 compared to baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). Serum HDL-C increased significantly up to 11.5% in the isoflavone group at the end of week 8 compared to baseline (P = 0.05), and the increment was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C. CONCLUSIONS This study indicates that daily administration of 100 mg soy isoflavones reduces serum Lp(a) and increases HDL-C concentration which are two determinants of cardiovascular disease in PD patients. CLINICALTRIALS.GOV: NCT03773029. REGISTRATION NUMBER AND DATE NCT03773029 - 2018.",2020,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C. ","['peritoneal dialysis (PD) patients', 'PD patients', 'peritoneal dialysis patients', '40 PD patients']","['soy isoflavone supplement', 'placebos', 'isoflavone', '100\xa0mg soy isoflavones', 'soy isoflavones', '100\xa0mg soy isoflavone', 'placebo']","['serum lipoprotein (a) [Lp(a', 'HDL-C concentration', 'mean changes of serum triglycerides, total cholesterol, and LDL-C', 'Serum Lp(a', 'serum lipids and lipoprotein (a', 'Serum HDL-C', 'serum triglycerides, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and Lp(a', 'serum Lp(a', 'serum lipids and Lp(a']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",40.0,0.329101,"There were no significant differences between the two groups in mean changes of serum triglycerides, total cholesterol, and LDL-C. ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: zahrayari_nut@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: hadtabibi@yahoo.com.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: NAJAFI63800@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: Hedayati@endocrine.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. Electronic address: nutritionist1993@gmail.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.04.023'] 2470,32513646,Development And Preliminary Evaluation Of The Effects Of An mHealth Web-based Platform (HappyAir™) on Adherence To a Maintenance Program After Pulmonary Rehabilitation In COPD Patients: Randomized Controlled Trial.,"BACKGROUND Pulmonary rehabilitation (PR) is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after PR by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease. OBJECTIVE This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir™) on adherence to a 1-year maintenance program applied after PR in COPD patients. METHODS COPD patients from three hospitals were randomized to a control group (CG) or an intervention group (HappyAir™ group [HG]). Patients from both groups received an 8-week program of PR and educational sessions about their illness. After completion of the process, only the HG performed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The CG only underwent the scheduled check-ups. Adherence to the program was rated using the CAP FISIO questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (CAT, SGRQ and EuroQOL-5D), exercise capacity (6MWT) and lung function. RESULTS In total, 44 patients were recruited and randomized in the CG (n=24) and HG (n=20). Eight patients dropped out for different reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR. CONCLUSIONS mHealth systems designed for COPD patients improve adherence to maintenance programs, as long as they are accompanied by disease awareness and patient involvement in management. CLINICALTRIAL ",2020,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR. ","['44 patients were recruited and randomized in the CG (n=24) and HG (n=20', 'COPD patients from three hospitals', 'COPD patients', 'COPD Patients']","['control group (CG) or an intervention group (HappyAir™ group [HG', 'mHealth Web-based Platform (HappyAir™', 'integrated care plan based on an mHealth web-based platform (HappyAir™', 'Maintenance Program', 'Pulmonary rehabilitation (PR']","['adherence to physical activity (Morisky-Green Test), quality of life (CAT, SGRQ and EuroQOL-5D), exercise capacity (6MWT) and lung function', 'adherence', 'Adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",44.0,0.0421553,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR. ","[{'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Jiménez-Reguera', 'Affiliation': 'CEU San Pablo University, Madrid, ES.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maroto López', 'Affiliation': 'Lovexair Foundation, Madrid, ES.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Fitch', 'Affiliation': 'Lovexair Foundation, Madrid, ES.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Juarros-Monteagudo', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, ES.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sánchez-Cortés', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, ES.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Rodríguez-Hermosa', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, ES.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Calle-Rubio', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, ES.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Hernández-Criado', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, ES.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Martín', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, ES.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Angulo-Díaz Parreño', 'Affiliation': 'CEU San Pablo University, Madrid, ES.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'CEU San Pablo University, Madrid, ES.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Vilaró', 'Affiliation': 'Ramon Llull University, Padilla 326, Barcelona, ES.'}]",JMIR mHealth and uHealth,['10.2196/18465'] 2471,32513785,BIOMARKER MODULATION STUDY OF CELECOXIB FOR CHEMOPREVENTION IN WOMEN AT INCREASED RISK FOR BREAST CANCER: A Phase II Pilot Study.,"In preclinical studies, celecoxib has been associated with reduced risk of breast cancer. In this study, the aim was to assess the biomodulatory effect of celecoxib on blood and benign breast tissue biomarkers in women at increased risk for breast cancer. Women at increased risk for breast cancer (5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma in situ, or previous ER-negative breast cancer) were treated with celecoxib at 400 mg orally twice daily for 6 months. Participants underwent random periareolar fine needle aspiration and blood draw at baseline and at 6 months for analysis of biomarkers: serum levels of insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER; as well as cytology. Forty-nine patients were eligible for analysis. Median IGFBP-1 levels increased significantly from 6.05 (ng/ml) at baseline to 6.93 (ng/ml) at 6 months (p=0.04), and median IGFBP-3 levels decreased significantly from 3593 to 3420 (ng/ml) (p=0.01). We also detected favorable changes in cytology of 52% of tested sites after 6 months' of celecoxib therapy. No changes in tissue Ki-67 and ER expression levels were observed. No grade 3 or 4 toxicity was recorded. Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial. A phase IIb placebo-controlled study with celecoxib could be considered for women at increased risk for breast cancer.",2020,Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial.,"['Women at increased risk for breast cancer (5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma in situ, or previous ER-negative breast cancer', 'IN WOMEN AT INCREASED RISK FOR BREAST CANCER', 'Forty-nine patients were eligible for analysis', 'women at increased risk for breast cancer']","['celecoxib', 'Celecoxib', 'placebo']","['insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER', 'tissue Ki-67 and ER expression levels', 'tolerated', 'grade 3 or 4 toxicity', 'Median IGFBP-1 levels', 'median IGFBP-3 levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517511', 'cui_str': '1.67'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0333977', 'cui_str': 'Atypical hyperplasia'}, {'cui': 'C0279563', 'cui_str': 'Lobular carcinoma in situ of breast'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",49.0,0.0559728,Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial.,"[{'ForeName': 'Soley', 'Initials': 'S', 'LastName': 'Bayraktar', 'Affiliation': 'Hematology/Oncology, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Baghaki', 'Affiliation': 'Hematology/Oncology, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Biostatistics, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Liu', 'Affiliation': 'Department of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Cente.'}, {'ForeName': 'Angelica M', 'Initials': 'AM', 'LastName': 'Gutierrez-Barrera', 'Affiliation': 'Breast Medical Oncology, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Division of Cancer Prevention and Population Science, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'Department of Breast Medical Oncology--424, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Sneige', 'Affiliation': 'Pathology, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Banu K', 'Initials': 'BK', 'LastName': 'Arun', 'Affiliation': 'Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center barun@mdanderson.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0095'] 2472,32513836,"Multicenter Phase 1 Trial of a DNA Vaccine Encoding the Androgen Receptor Ligand Binding Domain (pTVG-AR, MVI-118) in Patients with Metastatic Prostate Cancer.","PURPOSE Preclinical studies demonstrated that a DNA vaccine (pTVG-AR, MVI-118) encoding the androgen receptor ligand-binding domain (AR LBD) augmented antigen-specific CD8+ T cells, delayed prostate cancer progression and emergence of castration-resistant disease, and prolonged survival of tumor-bearing mice. This vaccine was evaluated in a multicenter phase 1 trial. EXPERIMENTAL DESIGN Patients with metastatic castration sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy were randomly assigned to receive pTVG-AR on one of two treatment schedules over one year, and with or without GM-CSF as a vaccine adjuvant. Patients were followed for 18 months. Primary objectives were safety and immune response. Secondary objectives included median time to PSA progression, and 18-month PSA-progression-free survival (PPFS). RESULTS Forty patients were enrolled at three centers. Twenty-seven patients completed treatment and 18 months of follow-up. Eleven patients (28%) had a PSA progression event before the 18-month timepoint. No grade 3 or 4 adverse events were observed. Of 30 patients with samples available for immune analysis, 14 (47%) developed Th1-type immunity to the AR LBD, as determined by IFNγ and/or granzyme B ELISPOT. Persistent IFNγ immune responses were observed irrespective of GM-CSF adjuvant. Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003). CONCLUSIONS pTVG-AR was safe and immunologically active in patients with mCSPC. Association between immunity and PPFS suggests that treatment may delay the time to castration resistance, consistent with preclinical findings, and will be prospectively evaluated in future trials.",2020,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003). ","['Patients with Metastatic Prostate Cancer', 'Patients with metastatic castration sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy', 'Forty patients were enrolled at three centers', 'patients with mCSPC']","['pTVG-AR', 'DNA', 'Vaccine Encoding the Androgen Receptor Ligand Binding Domain (pTVG-AR, MVI-118', 'DNA vaccine (pTVG-AR, MVI-118']","['safety and immune response', 'grade 3 or 4 adverse events', 'PSA progression event', 'median time to PSA progression, and 18-month PSA-progression-free survival (PPFS', 'PPFS', 'Persistent IFNγ immune responses', 'Th1-type immunity to the AR LBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",40.0,0.0764183,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003). ","[{'ForeName': 'Christos E', 'Initials': 'CE', 'LastName': 'Kyriakopoulos', 'Affiliation': 'Medicine, Hematology/Oncology, University of Wisconsin-Madison.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Eickhoff', 'Affiliation': 'BIOSTATISTICS AND MEDICAL INFORMATICS, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferrari', 'Affiliation': 'Medicine, Oncology, Montefiore Einstein Center for Cancer Care.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Schweizer', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin Carbone Cancer Center.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Olson', 'Affiliation': 'Department of Hematology and Medical Oncology, and Department of Urology, Emory University.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'Medicine, University of Wisconsin Carbone Cancer Center dm3@medicine.wisc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0945'] 2473,32521284,The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study.,"BACKGROUND The purpose of this study was to evaluate the effect of low-frequency self-administered vibration therapy into myofascial trigger points in the upper trapezius and levator scapulae on patients with chronic non-specific neck pain. METHODS Twenty-eight patients with chronic non-specific neck pain were randomly assigned into a vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention. Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold were assessed at baseline and after the first, fifth and 10th treatment sessions. FINDINGS Significant differences were found in the vibration group when compared to the control group after the treatment period: the vibration group reached lower Neck Disability Index scores (F = 4.74, P = .033, η 2  = 0.07) and greater pressure pain threshold values (F = 7.56, P = .01, η 2  = 0.10) than the control group. The vibration group reported a significant reduction in Neck Disability Index scores (χ2 = 19,35, P = .00, Kendall's W = 0.28) and an increase in pressure pain threshold (χ2 = 87,10, P = .00, Kendall's W = 0.73) between the assessment times over the course of the treatment. The mean increase in pressure pain threshold in the vibration group after the 10 sessions was 8.54 N/cm2, while the mean reduction in Neck Disability Index scores was 4.53 points. INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain. This tool could be recommended for people with non-specific neck pain.",2020,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","['people with non-specific neck pain', 'patients with chronic non-specific neck pain', 'Twenty-eight patients with chronic non-specific neck pain']","['low-frequency self-administered vibration therapy', 'vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention', 'vibration therapy']","['Neck Disability Index scores', 'Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold', 'pressure pain threshold', 'neck myofascial trigger points', 'pressure pain threshold values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0224475,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: lirios.duenas@uv.es.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'European Sleep Care Institute, San Vicente 16, 46023, Valencia, Spain. Electronic address: innovation@escinstitute.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain; ""Pain in Motion"" international research group, Belgium. Electronic address: enrique.lluch@uv.es.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Artacho-Ramírez', 'Affiliation': 'Department of Engineering Projects, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: miarra@dpi.upv.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mayoral', 'Affiliation': 'Physical Therapy Unit, Hospital Provincial de Toledo, Toledo, Spain. Electronic address: orlando.mayoral@uclm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balasch', 'Affiliation': 'Departamento de Estadística e Investigación Operativa Aplicadas y Calidad, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: sbalasch@eio.upv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balasch-Bernat', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: merce.balasch@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105071'] 2474,32521287,Evaluating the actual and perceived effectiveness of E-cigarette prevention advertisements among adolescents.,"BACKGROUND The efficacy of e-cigarette prevention ads among adolescents has seldom been studied. We examined the impact of ads from the The Real Cost vaping prevention media campaign on what adolescents think and believe about vaping. We also sought to test whether perceived message effectiveness (PME) served as a proxy for ad impact. METHODS Participants were 543 U.S. adolescents ages 13-17. In an online experiment, we randomized participants to either: 1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition). Participants in each condition viewed 2 videos in a random order. After ad exposure, the survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape. RESULTS The FDA's The Real Cost ads led to higher beliefs about the harms of vaping (p < .001), more negative attitudes toward vaping (p < .001), and lower intentions to vape (p < .05) compared to the control videos. The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos. Effects perceptions were associated with all three outcomes (all ps < 0.001, adjusting for both types of PME and covariates), but message perceptions did not offer additional predictive value. CONCLUSIONS Exposure to The Real Cost vaping prevention ads gave adolescents a more negative view of vaping and lowered their intentions to vape compared to control videos. Effects perceptions may be superior to message perceptions as a proxy for e-cigarette prevention ad impact.",2020,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"['Participants were 543 U.S. adolescents ages 13-17', 'adolescents']","[""1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition"", 'E-cigarette prevention advertisements']","['survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",543.0,0.0210644,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: noar@email.unc.edu.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Rohde', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Prentice-Dunn', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kresovich', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106473'] 2475,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS. METHODS Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events. RESULTS All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups. CONCLUSIONS BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups. ","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups. ","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554'] 2476,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities. METHODS Prospective, randomized, controlled, open, 12-month trial (NCT02374749). PARTICIPANTS consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group). MAIN OUTCOME change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management). RESULTS 502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). CONCLUSIONS AND RELEVANCE This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012'] 2477,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. METHODS The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. ETHICS AND DISSEMINATION The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132'] 2478,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty. PATIENTS AND METHODS Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device. RESULTS VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups. CONCLUSIONS Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983'] 2479,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended. METHOD To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website. RESULTS Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). CONCLUSION Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177'] 2480,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown. RESEARCH QUESTION To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces? METHODS Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position. RESULTS Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). SIGNIFICANCE It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044'] 2481,32521538,"Colon-delivered short-chain fatty acids attenuate the cortisol response to psychosocial stress in healthy men: a randomized, placebo-controlled trial.","Short-chain fatty acids (SCFAs) are products of microbial fermentation of dietary fiber in the colon and may mediate microbiota-gut-brain communication. However, their role in modulating psychobiological processes that underlie the development of stress- and anxiety-related disorders is not mechanistically studied in humans. In this triple-blind, randomized, placebo-controlled intervention trial, we examine in a parallel group design the effects of 1-week colonic SCFA-mixture delivery in doses equivalent to fermentation of 10 g or 20 g of arabinoxylan oligosaccharides on responses to psychosocial stress and fear tasks in 66 healthy men. We demonstrate that low and high doses of SCFAs significantly attenuate the cortisol response to psychosocial stress compared to placebo. Both doses of SCFAs increase serum SCFA levels and this increase in circulating SCFAs co-varies significantly with the attenuation of the cortisol response to psychosocial stress. Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings. These results demonstrate that colon-delivered SCFAs modulate hypothalamic-pituitary-adrenal axis reactivity to psychosocial stress, thereby supporting their hypothesized role in microbiota-gut-brain communication.",2020,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","['healthy men', '66 healthy men']","['Short-chain fatty acids (SCFAs', 'colonic SCFA-mixture delivery', 'SCFAs', 'Colon-delivered short-chain fatty acids', 'arabinoxylan oligosaccharides', 'placebo']","['fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings', 'cortisol response to psychosocial stress', 'serum SCFA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.031091,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Laboratory of Biological Psychology, Brain & Cognition, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Department of Gastrointestinal Health, Nestlé Research, Société des produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium. lukas.vanoudenhove@kuleuven.be.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0732-x'] 2482,32521556,A Randomized Trial of Voice-Generated Inpatient Progress Notes: Effects on Professional Fee Billing.,"BACKGROUND Prior evaluations of automated speech recognition (ASR) to create hospital progress notes have not analyzed its effect on professional revenue billing codes. As ASR becomes a more common method of entering clinical notes, clinicians, hospital administrators, and payers should understand whether this technology alters charges associated with inpatient physician services. OBJECTIVES This study aimed to measure the difference in professional fee charges between using voice and keyboard to create inpatient progress notes. METHODS In a randomized trial of a novel voice with ASR system, called voice-generated enhanced electronic note system (VGEENS), to generate physician notes, we compared 1,613 notes created using intervention (VGEENS) or control (keyboard with template) created by 31 physicians. We measured three outcomes, as follows: (1) professional fee billing levels assigned by blinded coders, (2) number of elements within each note domain, and (3) frequency of organ system evaluations documented in review of systems (ROS) and physical exam. RESULTS Participants using VGEENS generated a greater portion of high-level (99233) notes than control users (31.8 vs. 24.3%, p  < 0.01). After adjustment for clustering by author, the finding persisted; intervention notes were 1.43 times more likely (95% confidence interval [CI]: 1.14-1.79) to receive a high-level code. Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76). The number of physical exam components was unchanged. CONCLUSION Using this voice with ASR system as tested slightly increases documentation of patient symptom details without reliance on copy and paste and may raise physician charges. Increased provider reimbursement may encourage hospital and provider group to offer use of voice and ASR to create hospital progress notes as an alternative to usual methods.",2020,Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76).,[],"['1,613 notes created using intervention (VGEENS) or control (keyboard with template) created by 31 physicians', 'novel voice with ASR system, called voice-generated enhanced electronic note system (VGEENS', 'automated speech recognition (ASR']","['professional fee billing levels assigned by blinded coders, (2) number of elements within each note domain, and (3) frequency of organ system evaluations documented in review of systems (ROS) and physical exam', 'greater portion of high-level', 'number of physical exam components']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0460002', 'cui_str': 'Body system structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0489633', 'cui_str': 'Review of systems'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",99233.0,0.0952634,Notes created using voice contained an average of 1.34 more history of present illness components (95% CI: 0.14-2.54) and 1.62 more review of systems components (95% CI: 0.48-2.76).,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Garrison', 'Affiliation': 'Department of Health Services, University of Washington School of Public Health, and Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, United States.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Payne', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States.'}]",Applied clinical informatics,['10.1055/s-0040-1713134'] 2483,32521561,Factors Associated with Formula Feeding among Late Preterm Neonates.,"OBJECTIVE Late preterm births (delivery at 34-36 weeks) account for nearly three quarters of the preterm births and among them there is a knowledge gap about an important aspect of infant care: breast versus formula feeding. The aim of this study was to assess factors associated with formula feeding in late preterm neonates. STUDY DESIGN Secondary analysis of a multicenter randomized trial of antenatal corticosteroids for women at risk for late preterm birth. All women with a singleton pregnancy who delivered at 34 0/7 to 36 6/7 weeks were included. Women with no information on neonatal feeding or known fetal anomalies were excluded. The outcome evaluated was the type of neonatal feeding during hospital stay. Maternal and neonatal characteristics were compared among women who initiated breast versus formula feeding. Adjusted relative risks (aRRs) for formula feeding with 95% confidence intervals (CIs) were calculated. RESULTS Of the 2,831 women in the parent trial, 2,329 (82%) women met inclusion criteria and among them, 696 (30%) were formula feeding. After multivariable regression, the following characteristics were associated with an increased risk of formula feeding: maternal age < 20 years (aRR: 1.47, 95% CI: 1.20-1.80) or ≥35 years (aRR: 1.19, 95% CI: 1.02-1.40), never married status (aRR: 1.39, 95% CI: 1.20-1.60), government-assisted insurance (aRR: 1.41, 95% CI: 1.16-1.70), chronic hypertension (aRR: 1.19, 95% CI: 1.01-1.40), smoking (aRR: 1.51, 95% CI: 1.31-1.74), cesarean delivery (aRR: 1.16, 95% CI: 1.03-1.32), and admission to neonatal intensive care unit (aRR: 1.31, 95% CI: 1.16-1.48). Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding. CONCLUSION In this geographically diverse cohort of high-risk deliveries, 3 out 10 late preterm newborns were formula fed. Smoking cessation was a modifiable risk factor that may diminish the rate of formula feeding among late preterm births. KEY POINTS · Three of ten late preterm do not benefit from breastfeeding.. · Demographic characteristics are associated with type of feeding.. · Smoking cessation may improve the rate of breastfeeding..",2020,"Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding. ","['Late Preterm Neonates', 'late preterm neonates', 'Women with no information on neonatal feeding or known fetal anomalies', '2,831 women in the parent trial, 2,329 (82', 'All women with a singleton pregnancy who delivered at 34 0/7 to 36 6/7 weeks were included', 'women met inclusion criteria and among them, 696 (30%) were formula feeding', 'aRR', 'women at risk for late preterm birth']","['aRR', 'antenatal corticosteroids']","['chronic hypertension', 'cesarean delivery', 'risk of formula feeding: maternal age\u2009<\u200920 years (aRR', 'Hispanic ethnicity', 'rate of breastfeeding', 'type of neonatal feeding during hospital stay', 'Maternal and neonatal characteristics', 'government-assisted insurance ']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",2831.0,0.239817,"Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding. ","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Fishel Bartal', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0040-1712952'] 2484,32521605,"Growth, Physiology and Nutrient Use Efficiency in Eugenia dysenterica DC under Varying Rates of Nitrogen and Phosphorus.","The production of high-quality seedlings and their use in commercial planting reduce pressure on natural areas. Eugenia dysenterica DC is a native fruit tree from the Brazilian Cerrado, whose nutritional requirements are still unclear. This study aimed to evaluate the effects of nitrogen (N) and phosphorus (P) supplementation on the physiology, growth and nutrient uptake, and use efficiencies of E. dysenterica seedlings grown in glasshouse conditions. The following rates were used in separate experiments: 0, 50, 100, 200, and 400 mg dm -3 N and 0, 100, 200, 400, and 600 mg dm -3 P. The experiment was conducted in a randomized block with four replications. The lowest N rate (50 mg dm -3 ) increased the stomatal conductance (g S ) and, consequently, resulted in the highest transpiration ( E ), electron transport (ETR), and photosynthetic ( A ) rates. Also, rates of 50 mg dm -3 and 100 mg dm -3 N increased the Root Uptake Efficiency (RUE) and plant Nutrient Use Efficiency (NUE) for macronutrients and the RUE for micronutrients, stimulating plant growth. Phosphorous fertilization resulted in the maximum values for photosynthesis, electron transport rate, total dry mass, and NUE at the 200 mg dm -3 rate. The results of this study suggest that fertilization with 50 mg dm -3 N and 200 mg dm -3 P is suitable for the development of E. dysenterica seedlings.",2020,"N increased the Root Uptake Efficiency (RUE) and plant Nutrient Use Efficiency (NUE) for macronutrients and the RUE for micronutrients, stimulating plant growth.",[],['nitrogen (N) and phosphorus (P) supplementation'],"['stomatal conductance', 'maximum values for photosynthesis, electron transport rate, total dry mass, and NUE', 'highest transpiration ( E ), electron transport (ETR), and photosynthetic ( A ) rates', 'Root Uptake Efficiency (RUE) and plant Nutrient Use Efficiency (NUE) for macronutrients and the RUE for micronutrients, stimulating plant growth', 'Eugenia dysenterica']",[],"[{'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031764', 'cui_str': 'Photosynthesis'}, {'cui': 'C0013846', 'cui_str': 'Electron transfer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0763953', 'cui_str': 'NUE protein, silkworm'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0330928', 'cui_str': 'Ruta'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0597252', 'cui_str': 'Plant Development'}, {'cui': 'C1186984', 'cui_str': 'Eugenia'}]",,0.0481211,"N increased the Root Uptake Efficiency (RUE) and plant Nutrient Use Efficiency (NUE) for macronutrients and the RUE for micronutrients, stimulating plant growth.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Nogueira Dos Reis', 'Affiliation': 'Plant Tissue Culture Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Guimarães Silva', 'Affiliation': 'Plant Tissue Culture Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}, {'ForeName': 'Reginaldo', 'Initials': 'R', 'LastName': 'da Costa Santana', 'Affiliation': 'Plant Tissue Culture Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}, {'ForeName': 'Thales', 'Initials': 'T', 'LastName': 'Caetano de Oliveira', 'Affiliation': 'Plant Tissue Culture Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}, {'ForeName': 'Mariângela', 'Initials': 'M', 'LastName': 'Brito Freiberger', 'Affiliation': 'Plant Tissue Culture Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}, {'ForeName': 'Fábia', 'Initials': 'F', 'LastName': 'Barbosa da Silva', 'Affiliation': 'Plants Stress Study Laboratory, University of São Paulo, Luiz de QueirózAgriculture School, P.O. Box 9, 13418-900 Piracicaba, SP, Brazil.'}, {'ForeName': 'Elídio', 'Initials': 'E', 'LastName': 'Monteiro Júnior', 'Affiliation': 'Biodiversity Laboratory, Minas South Federal Institute of Science and Technology-Campus Poços de Caldas, 37713-100 Poços de Caldas, MG, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Ecophysiology and Plant Productivity Laboratory, Goiano Federal Institute of Science and Technology-Campus Rio Verde, P.O. Box 66, 75901-970 Rio Verde, GO, Brazil.'}]","Plants (Basel, Switzerland)",['10.3390/plants9060722'] 2485,32521736,"The Effect of Escitalopram on Central Serotonergic and Dopaminergic Systems in Patients with Cervical Dystonia, and Its Relationship with Clinical Treatment Effects: A Double-Blind Placebo-Controlled Trial.","Purpose: The pathophysiology of cervical dystonia (CD) is thought to be related to changes in dopamine and serotonin levels in the brain. We performed a double-blind trial with escitalopram (selective serotonin reuptake inhibitor; SSRI) in patients with CD. Here, we report on changes in dopamine D 2/3 receptor (D2/3R), dopamine transporter (DAT) and serotonin transporter (SERT) binding potential (BP ND ) after a six-week treatment course with escitalopram or placebo. Methods: CD patients had [123I]FP-CIT SPECT (I-123 fluoropropyl carbomethoxy-3 beta-(4-iodophenyltropane) single-photon emission computed tomography) scans, to quantify extrastriatal SERT and striatal DAT, and [123I]IBZM SPECT (I-123 iodobenzamide SPECT) scans to quantify striatal D2/3R BPND before and after six weeks of treatment with either escitalopram or placebo. Treatment effect was evaluated with the Clinical Global Impression scale for dystonia, jerks and psychiatric symptoms, both by physicians and patients. Results: In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND . Comparing scans after treatment with escitalopram (n = 8) to placebo (n = 8) showed a trend ( p = 0.13) towards lower extrastriatal SERT BPND in the SSRI group (median SERT occupancy of 64.6%). After treatment with escitalopram, patients who reported a positive effect on dystonia or psychiatric symptoms had significantly higher SERT occupancy compared to patients who did not experience an effect. Conclusion: Higher extrastriatal SERT occupancy after treatment with escitalopram is associated with a trend towards a positive subjective effect on dystonia and psychiatric symptoms in CD patients.",2020,"In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND .","['patients with CD', 'Patients with Cervical Dystonia, and Its Relationship with Clinical Treatment Effects', 'cervical dystonia (CD', 'CD patients']","['Placebo', '123I]FP-CIT SPECT (I-123 fluoropropyl carbomethoxy-3 beta-(4-iodophenyltropane) single-photon emission computed tomography) scans', 'escitalopram', 'escitalopram or placebo', 'escitalopram (selective serotonin reuptake inhibitor; SSRI', 'Escitalopram', 'placebo']","['SERT, DAT or D2/3R BP ND ', 'Clinical Global Impression scale for dystonia, jerks and psychiatric symptoms', 'Central Serotonergic and Dopaminergic Systems', 'dystonia and psychiatric symptoms', 'dystonia or psychiatric symptoms', 'SERT occupancy', 'extrastriatal SERT BPND', 'extrastriatal SERT occupancy', 'dopamine D 2/3 receptor (D2/3R), dopamine transporter (DAT) and serotonin transporter (SERT) binding potential (BP ND ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C3495673', 'cui_str': 'IODIDE ION I-123'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0170657', 'cui_str': 'Serotonin Transporter'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}]",,0.388244,"In both patients treated with escitalopram and placebo there were no significant differences after treatment in SERT, DAT or D2/3R BP ND .","[{'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Zoons', 'Affiliation': 'Department of Neurology, Zaans Medisch Centrum, 1502 DV Zaandam, The Netherlands.'}, {'ForeName': 'Marina A J', 'Initials': 'MAJ', 'LastName': 'Tijssen', 'Affiliation': 'Department of Neurology, University Medical Centre, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Yasmine E M', 'Initials': 'YEM', 'LastName': 'Dreissen', 'Affiliation': 'Department of Neurosurgery, Amsterdam University Medical Centre, location Academic Medical Centre, 1100 DD Amsterdam, The Netherlands.'}, {'ForeName': 'Marenka', 'Initials': 'M', 'LastName': 'Smit', 'Affiliation': 'Department of Neurology, University Medical Centre, 9713 GZ Groningen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Booij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, location Academic Medical Centre, 1100 DD Amsterdam, The Netherlands.'}]",Biomolecules,['10.3390/biom10060880'] 2486,32521745,"Effects of 6 Weeks of Traditional Resistance Training or High Intensity Interval Resistance Training on Body Composition, Aerobic Power and Strength in Healthy Young Subjects: A Randomized Parallel Trial.","Consistent practice of physical activity has well known positive effects on general health; however, time for exercise remains one major barrier for many. An acute bout of high intensity interval resistance training (HIIRT) increases acute resting energy expenditure (REE) and decreases respiratory ratio (RR), suggesting its potential role on weight loss and increased fatty acid oxidation. The aim of this study was to test the long-term effect of HIIRT on body composition, lipid profile and muscle strength using a randomized parallel trial. Twenty healthy young adults (22.15 1.95 years) were randomized to perform either a HIIRT ( N = 11) protocol, consisting of three sets of 6 repetitions at 6 repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2'30″ rest between sets or a traditional training (TRT, N = 9) protocol of 3 sets of 15 reps with 75 sec of rest between sets. Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements were taken before and after 8 weeks of training. Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05). REE and RR were unaltered as lipid profile. HIIRT represents a valid training method to improve muscle strength and mass, but its role on body weight control was not confirmed.",2020,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05).","['Twenty healthy young adults (22.15 1.95 years', 'Healthy Young Subjects']","['high intensity interval resistance training (HIIRT', 'HIIRT', 'Traditional Resistance Training or High Intensity Interval Resistance Training']","['Body Composition, Aerobic Power and Strength', 'Body composition, resting energy metabolism, aerobic capacity, muscle strength and blood measurements', 'endurance strength performance', 'lean body mass', 'weight loss and increased fatty acid oxidation', 'body composition, lipid profile and muscle strength', 'muscle strength', 'REE and RR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0429743', 'cui_str': 'Respiratory ratio'}]",20.0,0.041387,"Both protocols enhanced muscle strength, but only HIIRT improved endurance strength performance (+22.07%, p < 0.05) and lean body mass (+2.82%, p < 0.05).","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marcolin', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Psychology, Educational Science and Human Movement, University of Palermo, 90133 Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolzetta', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Berton', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sergi', 'Affiliation': 'Department of Medicine, University of Padova, 35122 Padova, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, 35122 Padova, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17114093'] 2487,32521782,"Effect of Morning vs. Evening Turmeric Consumption on Urine Oxidative Stress Biomarkers in Obese, Middle-Aged Adults: A Feasibility Study.","The circadian rhythm of biological systems is an important consideration in developing health interventions. The immune and oxidative defense systems exhibit circadian periodicity, with an anticipatory increase in activity coincident with the onset of the active period. Spice consumption is associated with enhanced oxidative defense. The objective of this study was to test the feasibility of a protocol, comparing the effects of morning vs. evening consumption of turmeric on urine markers of oxidative stress in obese, middle-aged adults. Using a within-sample design, participants received each of four clock time x treatment administrations, each separated by one week: morning turmeric; evening turmeric; morning control; evening control. Participants prepared for each lab visit by consuming a low-antioxidant diet for two days and fasting for 12 h. Urine was collected in the lab at baseline and one-hour post-meal and at home for the following five hours. The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions. The findings also revealed that the spice treatment did not elicit the expected antioxidant effect and that the six-hour post-treatment urine collection period did not detect differences in urine endpoints across treatments. This feasibility study revealed that modifications to the spice treatment and urine sampling timeline are needed before implementing a larger study.",2020,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"['obese, middle-aged adults', 'Obese, Middle-Aged Adults']","['morning vs. evening consumption of turmeric', 'Morning vs. Evening Turmeric Consumption']","['Urine Oxidative Stress Biomarkers', 'antioxidant effect']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3179302', 'cui_str': 'Antioxidant Effects'}]",,0.0773991,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gordon', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17114088'] 2488,32521785,An Exploration of the Effectiveness of a Peer-Led Pain Management Program (PAP) for Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences: A Pilot Randomized Controlled Trial.,"Background: 80% of nursing home residents have reported chronic pain, which is often accepted by older adults as part of aging. Peer support models are being used to help individuals manage their chronic conditions and overcome the challenges of limited healthcare resources. The aims of this study were: (i) to examine the effectiveness of a 12 week peer-led pain management program (PAP) for nursing home residents and (ii) to evaluate their experiences. Methods: A cluster randomized controlled trial (RCT) was used. The 12 week pain management program was provided for the experimental group. Outcomes were measured at three time points. The participants' satisfaction and acceptance were evaluated by a semi-structured interview after the program was completed. Results: Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels improved after the completion of the 12 week peer-led PAP. The pain-intensity level reported at week 12 was significantly lower in the experimental group than in the control group. Semi-structured interviews showed that the nursing home residents were satisfied with the pain education that they received. Conclusions: The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",2020,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.",['Nursing Home Residents with Chronic Pain and an Evaluation of Their Experiences'],"['12 week peer-led pain management program (PAP', 'Peer-Led Pain Management Program (PAP']","['pain-related and psychological outcome measures', 'pain-intensity level', 'chronic pain', 'Pain self-efficacy, pain intensity, pain interference, pain knowledge, and depression levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",,0.0648035,"The 12 week peer-led PAP appeared to improve the pain-related and psychological outcome measures in nursing home residents, and the feedback on the peer-led PAP from the nursing home residents was positive.","[{'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shuk Kwan', 'Initials': 'SK', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Shamay S M', 'Initials': 'SSM', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lo', 'Affiliation': 'Department of Geriatrics and Palliative Medicine, Shatin Hospital, Hospital Authority, Kowloon, Hong Kong, China.'}, {'ForeName': 'Suey Shuk Yu', 'Initials': 'SSY', 'LastName': 'Yeung', 'Affiliation': 'Department of Human Movement Sciences, Vrije Universiteit Amsterdam, 1081 HV Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17114090'] 2489,32521810,The Bluegreen Algae (AFA) Consumption over 48 Hours Increases the Total Number of Peripheral CD34+ Cells in Healthy Patients: Effect of Short-Term and Long-Term Nutritional Supplementation (Curcumin/AFA) on CD34+ Levels (Blood).,"Several active principles from plants could trigger the release of stem cells from the bone marrow. Stem cell mobilizers have shown side effects in patients. Thus, the purpose of this paper is to find the natural products from plants (curcuminoids, glycosinolate of sulforaphane, AFA bluegreen algae), which could be potential stem mobilizes without adverse side effects. The antioxidant curcumin [1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-2,5-dione], glycosinolate of sulforaphane (broccoli) or AFA ( Aphanizomenon flos ) extract promote beneficial effects in patients. The number of circulating stem cells were monitored by HSC marker-CD34 by flow cytometry in peripheral blood from healthy subjects. CD34 is a hematological stem cells (HSC) marker. A double-blind study was conducted in 22 healthy subjects. We have evaluated whether short-term AFA- Aphanizomenon flos aquae -algae or curcuminoids consumption (powder or liquid formulation) over 48 consecutive hours could increase the total number of peripheral CD34+ blood cells ( n = 22, n = 5 subjects/group). The total number of circulating CD34 + cells were quantified after short-term and long-term nutritional supplementation; their levels were compared with their own basal levels ( n = 5/group, controls: before taking any supplement) or placebo-treated patients ( n = 7); their average age was 54 years old. We also evaluated whether long-term nutritional supplementation with several nutraceuticals could enhance HSC mobilization by increasing the total number of peripheral CD-34+ cell after seven or 38 consecutive days of administration ( n = 5, with seven placebo-treated patients). The long-term administration take place with these doses/day [curcuminoids: 2000 mg/day, equivalent to 120 mg of curcuminoids/day), glycosinolate of sulforaphane (66 mg/day), plus AFA Algae bluegreen extract (400 mg/day)]. On the last day (10 A.M.) of treatment, blood samples were collected six hours after taking these supplements; the average age was 54 years old. Notably, the blue green AFA algae extract consumption over 48 h enhances HSC mobilization by increasing the total number of peripheral CD34+ cells. The long-term administration with curcuminoids, glycosinolate of sulforaphane, and AFA bluegreen algae extract also increased the total number of CD34-HSC cells after seven or 38 days of consecutive of administration in healthy subjects.",2020,The number of circulating stem cells were monitored by HSC marker-CD34 by flow cytometry in peripheral blood from healthy subjects.,"['Healthy Patients', 'treated patients ( n = 7); their average age was 54 years old', 'healthy subjects', '22 healthy subjects', 'patients']","['AFA Algae bluegreen extract', 'glycosinolate of sulforaphane', 'placebo', 'curcuminoids, glycosinolate of sulforaphane, and AFA bluegreen algae extract', 'antioxidant curcumin [1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-2,5-dione], glycosinolate of sulforaphane (broccoli) or AFA ( Aphanizomenon flos ) extract', 'blue green AFA algae extract consumption']","['total number of circulating CD34 + cells', 'total number of CD34-HSC cells', 'CD34+ Levels (Blood', 'Bluegreen Algae (AFA) Consumption', 'HSC mobilization', 'number of circulating stem cells', 'Total Number of Peripheral CD34+ Cells', 'total number of peripheral CD34+ cells', 'total number of peripheral CD34+ blood cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1565999', 'cui_str': '(11C)2-(2-(dimethylaminomethylphenylthio))-5-fluoromethylphenylamine'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0331720', 'cui_str': 'Aphanizomenon'}, {'cui': 'C1319009', 'cui_str': 'Blue green color'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}]",22.0,0.0700897,The number of circulating stem cells were monitored by HSC marker-CD34 by flow cytometry in peripheral blood from healthy subjects.,"[{'ForeName': 'José Joaquín', 'Initials': 'JJ', 'LastName': 'Merino', 'Affiliation': 'Department Farmacologia, Farmacognosia y Botánica, Facultad de Farmacia, Universidad Complutense de Madrid, 28040 \u200eMadrid\u200e, Spain.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Cabaña-Muñoz', 'Affiliation': 'Private Dentist Practice, Private Clinic, 30001 Murcia, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Pelaz', 'Affiliation': 'Stem Cell S.A Laboratory, 47151 Valladolid, Spain.'}]",Journal of personalized medicine,['10.3390/jpm10020049'] 2490,32521864,"Influences of neoadjuvant chemotherapy on clinical indicators, prognosis and neutrophil/lymphocyte ratio of stage IB2-IIB cervical cancer.","PURPOSE To investigate the influence of neoadjuvant chemotherapy on the efficacy, clinical indicators, prognosis and neutrophil/lymphocyte ratio (NLR) of stage IB2-IIB cervical cancer. METHODS 120 cervical cancer patients were selected and randomly divided into the control group (n=60) and the observation group (n=60). The patients in the observation group were treated with neoadjuvant chemotherapy combined with surgery, while those in the control group received treatment with surgery alone. The serum tumor markers [matrix metalloproteinase-9 (MMP-9), carcino-embryonic antigen (CEA) and cancer antigen 125 (CA-125)], immunoglobulins (Igs) (IgA and IgM), T-lymphocyte subsets [cluster of differentiation (CD) 4+, CD8+ and CD4+/CD8+], NLR, quality of life, change in cancer-related fatigue degree and clinical efficacy were compared before and after treatment between the two groups. RESULTS The levels of MMP-9, CEA, CA-125, NLR, IgA, IgM, CD4+ CD8+, CD4+/CD8+ and Cancer Fatigue Scale (CFS) were decreased, while the World Health Organization Quality of Life Scale Brief (WHOQOL-BREF) score was increased in both groups after treatment, and the observation group exhibited more apparent changes in those levels than the control group (p<0.05). The effective rate was higher, but the incidence rates of postoperative lymphatic metastasis, vascular invasion, parametrial invasion and positive margin were lower in the observation group than those in the control group (p<0.05). The observation group had longer survival time than the control group (p<0.05). CONCLUSION Neoadjuvant chemotherapy can effectively lower the levels of serum tumor markers and NLR, reduce the metastasis rate of cancer cells and the degree of cancer-related fatigue after operation, improve the quality of life and prolong the survival time.",2020,"The effective rate was higher, but the incidence rates of postoperative lymphatic metastasis, vascular invasion, parametrial invasion and positive margin were lower in the observation group than those in the control group (p<0.05).",['120 cervical cancer patients'],"['neoadjuvant chemotherapy combined with surgery', 'neoadjuvant chemotherapy', 'surgery alone']","['clinical indicators, prognosis and neutrophil/lymphocyte ratio of stage IB2-IIB cervical cancer', 'quality of life and prolong the survival time', 'incidence rates of postoperative lymphatic metastasis, vascular invasion, parametrial invasion and positive margin', 'serum tumor markers [matrix metalloproteinase-9 (MMP-9), carcino-embryonic antigen (CEA) and cancer antigen 125 (CA-125)], immunoglobulins (Igs) (IgA and IgM), T-lymphocyte subsets [cluster of differentiation (CD) 4+, CD8+ and CD4+/CD8+], NLR, quality of life, change in cancer-related fatigue degree and clinical efficacy', 'levels of MMP-9, CEA, CA-125, NLR, IgA, IgM, CD4+ CD8+, CD4+/CD8+ and Cancer Fatigue Scale (CFS', 'efficacy, clinical indicators, prognosis and neutrophil/lymphocyte ratio (NLR) of stage IB2-IIB cervical cancer', 'metastasis rate of cancer cells', 'longer survival time', 'effective rate', 'World Health Organization Quality of Life Scale Brief (WHOQOL-BREF) score']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024232', 'cui_str': 'Lymphatic Metastasis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C1332836', 'cui_str': 'Cancer fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0334227', 'cui_str': 'Tumor cells, malignant'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0281274,"The effective rate was higher, but the incidence rates of postoperative lymphatic metastasis, vascular invasion, parametrial invasion and positive margin were lower in the observation group than those in the control group (p<0.05).","[{'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, Ningbo No.6 Hospital, Ningbo, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Minbo', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2491,32521866,Efficacy of neoadjuvant chemotherapy combined with intraperitoneal hyperthermic chemotherapy in advanced ovarian cancer.,"PURPOSE To explore the efficacy and safety of neoadjuvant chemotherapy (NAC) combined with cytoreductive surgery (CRS) and postoperative intraperitoneal hyperthermic chemotherapy (IPHC) in the treatment of advanced ovarian cancer. METHODS 132 patients with advanced ovarian cancer admitted to our hospital from May 2013 to May 2016 were enrolled and randomly divided into control group (n=44), IPHC group (n=44) and NAC+IPHC group (n=44). The patients in the control group underwent CRS and postoperative TP chemotherapy (iv. drip of paclitaxel + peritoneal perfusion of cisplatin), those in IPHC group underwent the CRS and postoperative IPHC+TP chemotherapy, and those in the NAC+IPHC group received two cycles of preoperative NAC and postoperative IPHC+TP chemotherapy. The surgery indexes (operation time, amount of intraoperative bleeding, diameter of tumor and number of metastatic foci) were recorded. The clinical effective rate, changes in levels of serum tumor markers and adverse reactions were evaluated. Moreover, the tumor recurrence and survival of patients after treatment were recorded. RESULTS In NAC + IPHC group, the operation time, amount of intraoperative bleeding and of ascites, diameter of tumor and number of metastatic foci were all significantly reduced, and the optimal cytoreduction rate was increased compared with IPHC group and control group. The clinical effective rate was 43.2% (19/44), 61.4% (27/44) and 72.7% (32/44), respectively, in the three groups, with significant differences, and the clinical effective rate was obviously higher in NAC+IPHC group than in control group, while it had no significant difference in IPHC group compared with NAC+IPHC group or control group. After treatment, the levels of serum human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125) were evidently higher in NAC + IPHC group than in IPHC group, while they were also evidently higher in IPHC group than in control group. According to the follow-up results, the 1-year recurrence rate in NAC+IPHC group was remarkably lower than in control group, and the median progression-free survival in NAC+IPHC group and IPHC group was remarkably longer than in control group, while it had no significant difference between NAC+IPHC group and IPHC group. The median overall survival had no statistically significant differences among the three groups. CONCLUSIONS NAC combined with IPHC can significantly reduce the perioperative risk, increase the optimal cytoreduction rate and raise the clinical effective rate of CRS in the treatment of advanced ovarian cancer. Moreover, patients have good tolerance, and both tumor progression and survival of patients are significantly improved.",2020,"According to the follow-up results, the 1-year recurrence rate in NAC+IPHC group was remarkably lower than in control group, and the median progression-free survival in NAC+IPHC group and IPHC group was remarkably longer than in control group, while it had no significant difference between NAC+IPHC group and IPHC group.","['132 patients with advanced ovarian cancer admitted to our hospital from May 2013 to May 2016', 'advanced ovarian cancer']","['NAC + IPHC', 'NAC combined with IPHC', 'CRS and postoperative TP chemotherapy', 'neoadjuvant chemotherapy (NAC) combined with cytoreductive surgery (CRS) and postoperative intraperitoneal hyperthermic chemotherapy (IPHC', 'IPHC', 'neoadjuvant chemotherapy combined with intraperitoneal hyperthermic chemotherapy', 'CRS and postoperative IPHC+TP chemotherapy', 'paclitaxel + peritoneal perfusion of cisplatin', 'preoperative NAC and postoperative IPHC+TP chemotherapy', 'NAC+IPHC']","['clinical effective rate', '1-year recurrence rate', 'perioperative risk', 'levels of serum human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125', 'median progression-free survival', 'optimal cytoreduction rate', 'clinical effective rate, changes in levels of serum tumor markers and adverse reactions', 'efficacy and safety', 'median overall survival', 'surgery indexes (operation time, amount of intraoperative bleeding, diameter of tumor and number of metastatic foci', 'operation time, amount of intraoperative bleeding and of ascites, diameter of tumor and number of metastatic foci', 'tumor recurrence and survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4552183', 'cui_str': 'Hyperthermic chemotherapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0903042', 'cui_str': 'Human epididymis protein 4'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}]",132.0,0.0288807,"According to the follow-up results, the 1-year recurrence rate in NAC+IPHC group was remarkably lower than in control group, and the median progression-free survival in NAC+IPHC group and IPHC group was remarkably longer than in control group, while it had no significant difference between NAC+IPHC group and IPHC group.","[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, Yantaishan Hospital, Yantai 264001 China.'}, {'ForeName': 'Xingping', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': ''}, {'ForeName': 'Tianmei', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2492,32521871,Analysis of efficacy and prognosis of Osimertinib combined with docetaxel for non-small cell lung cancer.,"PURPOSE To explore the therapeutic effects and prognosis of osimertinib combined with docetaxel for non-small cell lung cancer (NSCLC). METHODS A total of 94 patients with NSCLC diagnosed in the oncology department of our hospital were selected and randomly divided into two groups of 47 patients each. Patients in the control group took osimertinib tablets, while patients in the drug combination group were given intravenous docetaxel in addition to the oral administration of osimertinib. The therapeutic effects, inflammatory factors, toxic and side effects and factors affecting prognosis were analyzed in the two groups. RESULTS The overall response rate (RR) and disease control rate (DCR) in the drug combination group were 25.53% and 57.44%, respectively, which were higher than those in the control group. Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients. After treatment, the levels of the above indicators were lower in the drug combination group than in the control group. Patients in the two groups demonstrated significantly different degrees of side effects during treatment, including fatigue, thrombocytopenia and neutropenia. Smoking history, Karnofsky performance scale (KPS) score and TNM staging were important indicators affecting the prognosis of NSCLC patients. KPS score <70 and TNM stage IV were independent risk factors for the prognosis of NSCLC patients. After follow-up for 2 years, it was found that the survival rate was remarkably different between the two groups. The survival rate was notably higher in the drug combination group than in the control group. CONCLUSIONS The therapeutic effect of osimertinib combined with docetaxel is better than that of osimertinib alone, but the toxic and side effects of combined use are significantly higher, suggesting that enteral administration should be conducted during the medication period. Patients with smoking history, advanced TNM stage and high KPS score tend to have a poor prognosis.",2020,"Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients.","['non-small cell lung cancer (NSCLC', 'Patients with smoking history, advanced TNM stage and high KPS score', 'non-small cell lung cancer', '94 patients with NSCLC diagnosed in the oncology department of our hospital were selected and randomly divided into two groups of 47 patients each']","['Osimertinib combined with docetaxel', 'docetaxel', 'intravenous docetaxel', 'osimertinib combined with docetaxel', 'osimertinib tablets']","['overall response rate (RR) and disease control rate (DCR', 'therapeutic effects, inflammatory factors, toxic and side effects and factors affecting prognosis', 'levels of the above indicators', 'fatigue, thrombocytopenia and neutropenia', 'Smoking history, Karnofsky performance scale (KPS) score and TNM staging', 'survival rate', 'levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1', 'side effects']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1515169', 'cui_str': 'TNM Staging System'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",94.0,0.0450507,"Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients.","[{'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, the affiliated No.2 People's Hospital of Nanjing Medical University, Changzhou, Nanjing 213003, China.""}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2493,32521872,Effect of molecular targeted therapy combined with radiotherapy on the expression and prognostic value of COX-2 and VEGF in bone metastasis of lung cancer.,"PURPOSE This study aimed to explore the effect of molecular targeted therapy combined with radiotherapy on the expression and prognostic value of cyclooxygenase-2 (COX-2) and vascular endothelial growth factor (VEGF) in bone metastasis of lung cancer. METHODS 82 patients with bone metastases of lung cancer who underwent targeted therapy combined with radiotherapy in Hubei Cancer Hospital were regarded as the experimental group, and another 64 patients with bone metastases of lung cancer who underwent conventional radiotherapy were regarded as the control group. Serum VEGF and COX-2 levels were measured by enzyme-linked immunosorbent assay (ELISA) before and after the treatment. The efficacy and adverse reactions of both groups were compared. RESULTS The levels of COX-2 and VEGF in serum of both groups were significantly lower than those before treatment (p<0.05). The effective rate and local tumor efficiency of the experimental group were significantly higher than those of the control group (p<0.05). The diarrhea and asthenia and vomiting events in the experimental group were significantly lower than those in the control group (p<0.05). No significant differences were found between the two groups in other adverse reactions (p>0.05). A significant positive correlation was found between COX-2 and VEGF in serum in the two groups before and after treatment; the survival rate of COX-2 and VEGF high expression group was significantly lower than in the low expression group (p<0.05); ECOG score, pathological type, COX-2 and VEGF level were independent risk factors of death in the experimental group. CONCLUSION Targeted therapy combined with radiotherapy has a strong inhibitory effect on the expression of COX-2 and VEGF in bone metastasis of lung cancer. There was a significant positive correlation between the expression of COX-2 and VEGF, and the use of targeted therapy combined with radiotherapy can significantly improve the efficacy and quality of life and to prolong survival.",2020,No significant differences were found between the two groups in other adverse reactions (p>0.05).,"['bone metastasis of lung cancer', '82 patients with bone metastases of lung cancer who underwent', 'in Hubei Cancer Hospital were regarded as the experimental group, and another 64 patients with bone metastases of lung cancer who underwent']","['conventional radiotherapy', 'targeted therapy combined with radiotherapy', 'cyclooxygenase-2 (COX-2) and vascular endothelial growth factor (VEGF', 'radiotherapy']","['survival rate of COX-2 and VEGF', 'levels of COX-2 and VEGF in serum', 'efficacy and quality of life and to prolong survival', 'efficacy and adverse reactions', 'Serum VEGF and COX-2 levels', 'effective rate and local tumor efficiency', 'ECOG score, pathological type, COX-2 and VEGF level', 'adverse reactions', 'COX-2 and VEGF in serum', 'diarrhea and asthenia and vomiting events']","[{'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",82.0,0.0195552,No significant differences were found between the two groups in other adverse reactions (p>0.05).,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan 430079, P.R.China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Caibao', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Youying', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2494,32521876,A randomized study comparing two hypofractioned 3-D conformal radiotherapy for stage IIIb-IV non small cell lung cancer.,"PURPOSE We compared the safety and efficacy of two hypofractionated irradiation schedules for elderly and low performance status patients with inoperable symptomatic non-small cell lung cancer (NSCLC). METHODS Patients that entered the study were either unfit or without response concerning chemotherapy. We randomized 14 patients (group A) vs 15 patients (group B) who underwent two different hypofractionated radiotherapy schedules. Group Α patients underwent a scheme of 13x3 Gy, while group B patients received 2x8.5 Gy and one fraction of 6 Gy one week apart. Efficacy was assessed in terms of disease-free survival (DFS), tumor response and overall survival (OS).Toxicity according to RTOG/EORTC criteria and duration of symptoms were also evaluated. RESULTS Median follow up was 3 years. Median age was 64.5 years (group A) and 73 years (group B). Mean values for symptom palliation were higher for group B vs group A (3.20±1.21 vs 2.21±0.97, p=0.037), respectively. EORTC/RTOG toxicity was significantly higher (p=0.046) for group A (1.57±0.51) vs group B (1.13±0.35). Duration of toxicity was significantly lower in group B compared to group A (p=0.001). Median OS was similar between groups, while DFS was better in group B than group A (p=0.023). CONCLUSIONS Although safe conclusions are difficult to be ascertained, hypofractionated schedule B might be an alternative scheme in elderly and low performance status patients offering adequate palliation, good tumor control and acceptable toxicity.",2020,"Median OS was similar between groups, while DFS was better in group B than group A (p=0.023). ","['Patients that entered the study were either unfit or without response concerning chemotherapy', '14 patients (group A) vs 15 patients (group B) who underwent two different hypofractionated radiotherapy schedules', 'Median age was 64.5 years (group A) and 73 years (group B', 'elderly and low performance status patients with inoperable symptomatic non-small cell lung cancer (NSCLC', 'stage IIIb-IV non small cell lung cancer']",['hypofractioned 3-D conformal radiotherapy'],"['EORTC/RTOG toxicity', 'Median OS', 'disease-free survival (DFS), tumor response and overall survival (OS).Toxicity according to RTOG/EORTC criteria and duration of symptoms', 'Duration of toxicity', 'safety and efficacy', 'Efficacy', 'Mean values for symptom palliation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",14.0,0.0608404,"Median OS was similar between groups, while DFS was better in group B than group A (p=0.023). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zygogianni', 'Affiliation': 'National and Kapodistrian University of Athens, Medical School, 1st Department of Radiology, Radiotherapy Unit, Aretaieion University Hospital, Athens, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Platoni', 'Affiliation': ''}, {'ForeName': 'Eyridiki', 'Initials': 'E', 'LastName': 'Patriki', 'Affiliation': ''}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Nikoloudi', 'Affiliation': ''}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Kougioumtzopoulou', 'Affiliation': ''}, {'ForeName': 'Eyfrosini', 'Initials': 'E', 'LastName': 'Kypraiou', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Trogkanis', 'Affiliation': ''}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Efstathopoulos', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Georgakopoulos', 'Affiliation': ''}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Karaiskos', 'Affiliation': ''}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Malagari', 'Affiliation': ''}, {'ForeName': 'Maria Aggeliki', 'Initials': 'MA', 'LastName': 'Kalogeridi', 'Affiliation': ''}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kelekis', 'Affiliation': ''}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Kouloulias', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2495,32521888,Effectiveness of a large-calibre transanal drainage tube on the prevention of anastomotic leakage after anterior resection for rectal cancer.,"PURPOSE Anastomotic leakage (AL) is one of the most serious complications of colorectal surgery. We investigated whether the large-calibre transanal drainage tube (LTDT) placement could reduce AL after anterior resection for rectal cancer. METHODS We restrospectively analyzed 222 patients who underwent anterior resection at our institution. The patients were divided into the large-calibre transanal drainage tube (LTDT) and non-transanal drainage tube (NTDT) groups according to whether the large-calibre transanal drainage tube was placed in the operation. Clinical characteristics and postoperative complication were compared between the LTDT and NTDT groups. RESULTS In the LTDT group, AL occurred in 0 patient, whereas it occurred in 9 patients in the NTDT group. The rate of AL was significantly lower in the LTDT group (0 vs. 6.6%; p=0.015). Eight cases of AL were treated conservatively. One case developed severe peritonitis and underwent re-operation receiving temporary stoma.No perioperative death occurred in this series. CONCLUSIONS The large-calibre transanal drainage tube effectively prevented the occurrence of anastomotic leakage after anterior resection for rectal cancer and increased the safety of the surgery.",2020,The large-calibre transanal drainage tube effectively prevented the occurrence of anastomotic leakage after anterior resection for rectal cancer and increased the safety of the surgery.,"['222 patients who underwent anterior resection at our institution', 'after anterior resection for rectal cancer']","['large-calibre transanal drainage tube', 'LTDT', 'large-calibre transanal drainage tube (LTDT) placement', 're-operation receiving temporary stoma', 'large-calibre transanal drainage tube (LTDT) and non-transanal drainage tube (NTDT']","['severe peritonitis', 'anastomotic leakage', 'AL', 'rate of AL', 'Clinical characteristics and postoperative complication', 'perioperative death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1301895', 'cui_str': 'Perioperative death'}]",222.0,0.017529,The large-calibre transanal drainage tube effectively prevented the occurrence of anastomotic leakage after anterior resection for rectal cancer and increased the safety of the surgery.,"[{'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'No. 2 Department of Gastrointestinal Surgery, the affiliated Hospital of Putian University, Putian, China.'}, {'ForeName': 'Feiteng', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2496,32521890,Sorafenib combined with transarterial chemoembolization prolongs survival of patients with advanced hepatocellular carcinoma.,"PURPOSE To explore the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma. METHODS 118 patients with advanced hepatocellular carcinoma treated in our hospital from June 2014 to June 2016 were collected and randomly divided into the Sorafenib+TACE group (treated with Sorafenib combined with TACE, n=59) and the TACE group (n=59). The clinical efficacy, the changes in levels of serum vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF) and alpha fetoprotein (AFP) before and after treatment, adverse reactions and postoperative survival of patients were observed and recorded. RESULTS The objective response rate (ORR) and the disease control rate (DCR) were 55.9% (33/59) and 86.4% (51/59) in the Sorafenib+TACE group, and 37.3% (22/59) and 67.8% (40/59) in the TACE group. Both ORR and DCR in the Sorafenib+TACE group were significantly superior to those in the TACE group (p=0.022, p=0.027). Main adverse reactions after treatment included myelosuppression, fever, rash, gastrointestinal reactions, hepatalgia, hypertension and hand-foot syndrome, mostly of grade I-II, which were all improved after dose reduction and symptomatic treatment. The incidence rates of rash, diarrhea, hypertension and hand-foot syndrome in the Sorafenib+TACE group were obviously higher than those in the TACE group (p<0.001, p=0.002, p=0.002, p<0.001). The levels of serum VEGF, bFGF and AFP declined significantly in both groups after treatment compared with those before treatment (p=0.013, p<0.001, p<0.001), while they were evidently lower in the Sorafenib+TACE group than in the TACE group after treatment (p<0.001, p=0.016, p<0.001). Follow-up results showed that the overall survival in the Sorafenib+TACE group was significantly longer than in the TACE group (p=0.030). CONCLUSION Compared with TACE alone, Sorafenib combined with TACE can significantly improve ORR and DCR, obviously reduce the levels of serum VEGF, bFGF and AFP, and prolong the survival of patients with advanced hepatocellular carcinoma, while the adverse reactions are tolerable, so it is worthy of clinical popularization and application.",2020,"The levels of serum VEGF, bFGF and AFP declined significantly in both groups after treatment compared with those before treatment (p=0.013, p<0.001, p<0.001), while they were evidently lower in the Sorafenib+TACE group than in the TACE group after treatment (p<0.001, p=0.016, p<0.001).","['advanced hepatocellular carcinoma', '118 patients with advanced hepatocellular carcinoma treated in our hospital from June 2014 to June 2016', 'patients with advanced hepatocellular carcinoma']","['TACE', 'sorafenib combined with transarterial chemoembolization (TACE', 'TACE alone, Sorafenib combined with TACE', 'Sorafenib combined with TACE', 'Sorafenib+TACE', 'Sorafenib combined with transarterial chemoembolization']","['ORR and DCR', 'adverse reactions and postoperative survival', 'overall survival', 'efficacy and safety', 'incidence rates of rash, diarrhea, hypertension and hand-foot syndrome', 'levels of serum VEGF, bFGF and AFP', 'myelosuppression, fever, rash, gastrointestinal reactions, hepatalgia, hypertension and hand-foot syndrome', 'objective response rate (ORR) and the disease control rate (DCR', 'levels of serum vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF) and alpha fetoprotein (AFP']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0380603', 'cui_str': 'Fibroblast Growth Factor-2'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",118.0,0.0291935,"The levels of serum VEGF, bFGF and AFP declined significantly in both groups after treatment compared with those before treatment (p=0.013, p<0.001, p<0.001), while they were evidently lower in the Sorafenib+TACE group than in the TACE group after treatment (p<0.001, p=0.016, p<0.001).","[{'ForeName': 'Quanguo', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2497,32521891,Efficacy of transcatheter arterial chemoembolization combined with 125I seed implantation and three-dimensional conformal radiotherapy in advanced primary hepatocellular carcinoma.,"PURPOSE To investigate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with iodine-125 (125I) seed implantation and three-dimensional conformal radiotherapy (3DCRT) in treating primary hepatocellular carcinoma (HCC) in the advanced stage. METHODS A total of 110 primary HCC patients in the advanced stage without operative indications admitted to and treated in our hospital from March 2014 to March 2016 were selected and divided into two groups using randomized single-blind method to receive TACE and 125I seed implantation combined with 3DCRT (TACE + 125I + 3DCRT group, n=55) as well as TACE combined with 3DCRT (TACE + 3DCRT group, n=55) separately. The short-term clinical efficacy, changes in the levels of alpha fetoprotein (AFP), insulin-like growth factor-II (IGF-II) and insulin-like growth factor binding protein-2 (IGFBP-2) in the serum before and after treatment, adverse reactions and long-term survival of the patients were observed and recorded. RESULTS TACE + 125I + 3DCRT group had significantly higher objective response rate (ORR) and disease control rate (DCR) than TACE + 3DCRT group [83.6% (46/55) vs. 63.6% (35/55), 96.4% (53/55) vs. 83.6% (46/55)] (p=0.029, p=0.043). The levels of serum AFP, IGF-II and IGFBP-2 declined markedly after treatment in both groups compared with those before treatment (p<0.001), while they were evidently lower in TACE + 125I + 3DCRT group than TACE + 3DCRT group (p=0.008, p=0.004, p=0.018). The major adverse reactions in the patients after treatment included bone marrow suppression, fever, gastrointestinal reaction, transaminase elevation, radiodermatitis, radiation-induced hepatitis and radiation-induced gastric ulcer, most of which were in I-II grade. There was no statistically significant difference in the incidence rate of adverse reactions between the two groups of patients after chemoradiotherapy (p>0.05). The results of follow-up indicated that TACE + 125I + 3DCRT group had notably longer overall survival (OS) and progression-free survival (PFS) than TACE + 3DCRT group (p=0.030, p=0.016). CONCLUSION The treatment scheme of TACE and 125I seed implantation combined with 3DCRT have exact efficacy in advanced primary HCC, which can distinctly increase the ORR and DCR, prominently reduce the levels of serum AFP, IGF-II and IGFBP-2 and prolong the survival time of the patients without increasing adverse reactions compared with TACE + 3DCRT, so it is worthy of clinical popularization and application.",2020,There was no statistically significant difference in the incidence rate of adverse reactions between the two groups of patients after chemoradiotherapy (p>0.05).,"['110 primary HCC patients in the advanced stage without operative indications admitted to and treated in our hospital from March 2014 to March 2016', 'primary hepatocellular carcinoma (HCC) in the advanced stage', 'advanced primary hepatocellular carcinoma']","['TACE', 'transcatheter arterial chemoembolization (TACE) combined with iodine-125 (125I) seed implantation and three-dimensional conformal radiotherapy (3DCRT', '3DCRT', 'TACE + 3DCRT', 'transcatheter arterial chemoembolization combined with 125I seed implantation and three-dimensional conformal radiotherapy', 'TACE and 125I seed implantation combined with 3DCRT (TACE + 125I + 3DCRT', 'TACE + 125I + 3DCRT', 'TACE combined with 3DCRT (TACE + 3DCRT']","['overall survival (OS) and progression-free survival (PFS', 'ORR and DCR', 'survival time', 'bone marrow suppression, fever, gastrointestinal reaction, transaminase elevation, radiodermatitis, radiation-induced hepatitis and radiation-induced gastric ulcer', 'efficacy and safety', 'adverse reactions and long-term survival', 'objective response rate (ORR) and disease control rate (DCR', 'levels of alpha fetoprotein (AFP), insulin-like growth factor-II (IGF-II) and insulin-like growth factor binding protein-2 (IGFBP-2', 'incidence rate of adverse reactions', 'levels of serum AFP, IGF-II and IGFBP-2']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0021666', 'cui_str': 'insulin-like growth factor 2'}, {'cui': 'C0123257', 'cui_str': 'Insulin-like growth factor binding protein 2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0373538', 'cui_str': 'Alpha-1-fetoprotein measurement, serum'}]",110.0,0.0451957,There was no statistically significant difference in the incidence rate of adverse reactions between the two groups of patients after chemoradiotherapy (p>0.05).,"[{'ForeName': 'Huanyun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiotherapy, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Aiyan', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2498,32521896,Efficacy and prognosis analyses of apatinib combined with S-1 in third-line chemotherapy for advanced gastric cancer.,"PURPOSE To explore the efficacy and safety of apatinib (an anti-angiogenic drug) combined with S-1 (a fluorouracil drug) in the third-line chemotherapy for advanced gastric cancer, and to analyze the factors influencing the prognosis. METHODS Eighty-four patients with advanced gastric cancer, who did not respond to second-line or above chemotherapy and were treated in our hospital were enrolled and divided into Apatinib+S-1 group (n=42) and S-1 group (n=42), based on different treatments applied. Next, the clinical responses and adverse reactions of patients were observed and recorded. The patients were followed up through the outpatient service and telephone to record their survival and disease progression. Additionally, the factors affecting the prognosis of patients were analyzed. RESULTS The objective response rate (ORR) and disease control rate (DCR) in the Apatinib+S-1 group were 9.5% (4/42) and 71.4% (30/42), respectively, which were significantly higher than those in the S-1 group. The main adverse reactions after therapy included neutropenia, thrombocytopenia, anemia, stomatitis, hypertension, proteinuria, hand-foot syndrome and gastrointestinal reaction, which were mostly of grade I-II. The incidence rates of hypertension, proteinuria and hand-foot syndrome were 42.9%, 26.2%, and 23.8%, respectively, in the Apatinib+S-1 group, which were overtly higher than those in the S-1 group. There was no statistically significant difference in the overall survival (OS) of patients between two groups (p=0.063), while the progression free survival (PFS) of patients was overtly longer in the Apatinib + S-1 group than that in S-1 group. Univariate analysis of PFS showed that the PFS of patients with high differentiation of tumor or post-treatment proteinuria or hand-foot syndrome was evidently higher than that of patients without high differentiation of tumor or post-treatment proteinuria or hand-foot syndrome. CONCLUSION Patients with advanced gastric cancer achieve relatively satisfactory short-term therapeutic effects after treatment with apatinib combined with S-1 in the third-line therapy, whose PFS is notably better than those treated with S-1 alone, and they are tolerant to adverse reactions. Highly differentiated tumors and post-treatment proteinuria and hand-foot syndrome are predictable factors for the PFS of patients.",2020,"There was no statistically significant difference in the overall survival (OS) of patients between two groups (p=0.063), while the progression free survival (PFS) of patients was overtly longer in the Apatinib + S-1 group than that in S-1 group.","['Eighty-four patients with advanced gastric cancer, who did not respond to second-line or above chemotherapy and were treated in our hospital were enrolled and divided into Apatinib+S-1 group (n=42) and S-1 group (n=42', 'advanced gastric cancer', 'Patients with advanced gastric cancer']","['apatinib combined with S-1 in third-line chemotherapy', 'apatinib (an anti-angiogenic drug) combined with S-1 (a fluorouracil drug']","['progression free survival (PFS', 'neutropenia, thrombocytopenia, anemia, stomatitis, hypertension, proteinuria, hand-foot syndrome and gastrointestinal reaction', 'incidence rates of hypertension, proteinuria and hand-foot syndrome', 'efficacy and safety', 'objective response rate (ORR) and disease control rate (DCR', 'clinical responses and adverse reactions', 'overall survival (OS']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",84.0,0.0317805,"There was no statistically significant difference in the overall survival (OS) of patients between two groups (p=0.063), while the progression free survival (PFS) of patients was overtly longer in the Apatinib + S-1 group than that in S-1 group.","[{'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xi', 'Affiliation': ''}, {'ForeName': 'Guangling', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2499,32521920,Comparison of efficacy and long-term survival of laparoscopic radical nephrectomy with partial nephrectomy in the treatment of patients with early renal cell carcinoma Running title: laparoscopic radical nephrectomy.,"PURPOSE To compare the efficacy and long-term survival of laparoscopic radical nephrectomy (LRN) with laparoscopic partial nephrectomy (LPN) in the treatment of patients with early renal cell carcinoma (RCC). METHODS A retrospective analysis was performed on the medical records of 146 patients, aged 40-60 years, with T1bN0M0 RCC admitted to Chongqing Three Gorges Central Hospital. The patients were divided into a study group (n=62) treated with LPN and a control group (n=84) treated with LRN according to surgical methods. The renal function, one month after operation and surgery-related indicators and the incidence of postoperative complications were analyzed. RESULTS One month after operation GFR was significantly higher in the study group than in the control group (p<0.05), which was lower than that before operation in the two groups (p<0.05). CONCLUSION The short- and long-term efficacy of LPN is similar to that of LRN in the treatment of T1bN0M0 RCC, but LPN better preserves the renal function, which has a potential value in reducing cardiovascular events.",2020,"One month after operation GFR was significantly higher in the study group than in the control group (p<0.05), which was lower than that before operation in the two groups (p<0.05). ","['patients with early renal cell carcinoma', 'patients with early renal cell carcinoma (RCC', '146 patients, aged 40-60 years, with T1bN0M0 RCC admitted to Chongqing Three Gorges Central Hospital']","['laparoscopic radical nephrectomy (LRN', 'Running title: laparoscopic radical nephrectomy', 'LPN', 'LPN and a control group (n=84) treated with LRN', 'laparoscopic partial nephrectomy (LPN', 'laparoscopic radical nephrectomy with partial nephrectomy', 'LRN']","['renal function', 'postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0563005', 'cui_str': 'Gorge'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2584683', 'cui_str': 'Laparoscopic radical nephrectomy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",146.0,0.017637,"One month after operation GFR was significantly higher in the study group than in the control group (p<0.05), which was lower than that before operation in the two groups (p<0.05). ","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Department of Urology, Chongqing Three Gorges Central Hospital, Chongqing 404000, P.R. China.'}, {'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Zhihai', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2500,32521927,"Clinical significance of changes in AFP, HTATIP2/TIP30, B7-H4 and inflammatory cytokines after transcatheter arterial chemoembolization.","PURPOSE To explore the clinical significance of changes in alpha-fetoprotein (AFP), HIV-1 TAT interactive protein 2/TAT interactive protein 30 (HTATIP2/TIP30), B7-H4 and inflammatory cytokines after transcatheter arterial chemoembolization (TACE). METHODS A total of 84 hepatocellular carcinoma (HCC) patients admitted to the Department of Hepatobiliary Surgery and the Department of Interventional Radiology of our hospital from January 1, 2017 to December 31, 2018 were randomly enrolled and divided into an experimental group and a control group according to treatment methods. The expression levels of AFP mRNA, HTATIP2/TIP30, B7-H4 and inflammatory cytokines were detected before and after treatment, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed. RESULTS The AFP expression level in the two groups of patients was lower after treatment than before treatment, this reduction being more obvious in the experimental group (receiving TACE) than in the control group. Although the levels of serum HTATIP2/TIP30 and B7-H4 were decreased after treatment in both groups, and they were lower after treatment than those before treatment in the control group, lower levels were registered in the control group. Both groups of patients had lower expression levels of tumor necrosis factor-alpha (TNF-α) and interleukin 6 (IL-6) after treatment compared with those before treatment, this decrease being more significant in the experimental group than in the control group. Moreover, the total short-term efficacy rate and the improvement rate of the quality of life were higher in the experimental group than in the control group, although no statistical difference in the survival rate was found between the two groups after 1-year follow-up. The serum level of B7-H4 in the group with good efficacy was lower than in the group with poor efficacy before treatment, and it declined in both groups after treatment, with a lower level in the former than in the latter. Furthermore, the group with good efficacy had a lower level of serum HTATIP2/TIP30 than the group with poor efficacy, while both groups had a decreased level after treatment, with a lower level in the former than in the latter. CONCLUSION Interventional therapy for primary HCC has good short-term efficacy. It can reduce the levels of serum HTATIP2/TIP30, B7-H4, AFP and inflammation-related indexes, improve the liver function and the patients' quality of life.",2020,"The expression levels of AFP mRNA, HTATIP2/TIP30, B7-H4 and inflammatory cytokines were detected before and after treatment, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed. ","['84 hepatocellular carcinoma (HCC) patients admitted to the Department of Hepatobiliary Surgery and the Department of Interventional Radiology of our hospital from January 1, 2017 to December 31, 2018']",['transcatheter arterial chemoembolization (TACE'],"['alpha-fetoprotein (AFP), HIV-1 TAT interactive protein 2/TAT interactive protein 30 (HTATIP2/TIP30), B7-H4 and inflammatory cytokines', 'expression levels of tumor necrosis factor-alpha (TNF-α) and interleukin 6 (IL-6', 'improvement rate of the quality of life', 'expression levels of AFP mRNA, HTATIP2/TIP30, B7-H4 and inflammatory cytokines', 'AFP expression level', 'levels of serum HTATIP2/TIP30, B7-H4, AFP and inflammation-related indexes, improve the liver function', 'levels of serum HTATIP2/TIP30 and B7-H4', 'total short-term efficacy rate', 'survival rate', 'serum level of B7-H4', 'AFP, HTATIP2/TIP30, B7-H4 and inflammatory cytokines', 'level of serum HTATIP2/TIP30']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034602', 'cui_str': 'Interventional radiology - specialty'}]","[{'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C1336632', 'cui_str': 'KAT5 protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",84.0,0.0192198,"The expression levels of AFP mRNA, HTATIP2/TIP30, B7-H4 and inflammatory cytokines were detected before and after treatment, the short-term efficacy was followed up and analyzed, and the correlation between the two was statistically analyzed. ","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatobiliary Surgery, the second affiliated Hospital of Nantong University; the first People's Hospital of Nantong City, Nantong, China.""}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zang', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': ''}, {'ForeName': 'Wenyang', 'Initials': 'W', 'LastName': 'Niu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 2501,32521976,[Effect of an oral nutritional supplementation on nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy: A multi-center prospective randomized control trial].,"Objective: To evaluate the effect of oral nutritional supplementation (ONS) on the nutritional status and quality of life in patients with colorectal cancer and postoperative adjuvant chemotherapy. Methods: This study was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13003798). A multi-center randomized controlled trial was conducted. Colorectal cancer patients who underwent radical surgery and postoperative adjuvant chemotherapy, and had nutritional risk (nutrition risk screening 2002 score ≥3) when discharge from hospital in six hospitals (Beijing Hospital, Peking University Third Hospital, Guangzhou Nanfang Hospital, Shanghai Xinhua Hospital, Shanghai Ruijin Hospital, and Shanghai The Sixth People's Hospital) from June 2013 to August 2015 were prospectively enrolled. These patients were randomly divided into the ONS group and control group. Patients in the ONS group received dietary guidance and oral nutritional supplements (2092 kJ/day, whole protein enteral nutrition) for 90 days after discharge from hospital, while patients in the control group only received dietary guidance. Anthropometric measurements (body weight, body mass index [BMI], upper arm circumference, gripping power of the dominant hand, triceps skin fold), nutrition-related laboratory tests (hemoglobin, albumin, prealbumin, total cholesterol, triglyceride), gastrointestinal function scores and quality of life (evaluated by EuroQol five dimensions questionnaire) were collected and compared at baseline (at discharge), and at 30-day, 60-day and 90-day after discharge. Results: A total of 90 patients were included into this multi-center study, of whom 5 patients dropped out, 43 patients were assigned to the ONS group and 42 patients to the control group. Compared with baseline, the body weight of patients in the ONS group increased by (1.523±0.525) kg at 60-day and (1.967±0.661) kg at 90-day, which were significantly higher than those of patients in the control group [60-day: (-0.325±0.518) kg, P =0.015; 90-day: (-0.224±0.705) kg, P =0.027, respectively]. A similar pattern was observed for BMI, the ONS group increased by (0.552±0.203) kg/m(2) at 60-day and (0.765±0.205) kg/m(2) at 90-day, which were significantly higher than those of patients in control group [60-day: (-0.067±0.202) kg/m(2), P =0.034; 90-day: (0.022±0.210) kg/m(2), P =0.013]. No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all P >0.05). Furthermore, there were no significant differences of improvement in gastrointestinal function and quality of life between two groups (all P >0.05). Conclusion: Oral nutritional supplements can improve the body weight and BMI of colorectal cancer patients with nutritional risk receiving postoperative adjuvant chemotherapy, though it does not improve the quality of life.",2020,No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all P >0.05).,"['A total of 90 patients were included into this multi-center study, of whom 5 patients dropped out, 43 patients were assigned to the ONS group and 42 patients to the control group', ""Colorectal cancer patients who underwent radical surgery and postoperative adjuvant chemotherapy, and had nutritional risk (nutrition risk screening 2002 score ≥3) when discharge from hospital in six hospitals (Beijing Hospital, Peking University Third Hospital, Guangzhou Nanfang Hospital, Shanghai Xinhua Hospital, Shanghai Ruijin Hospital, and Shanghai The Sixth People's Hospital) from June 2013 to August 2015 were prospectively enrolled"", 'patients with colorectal cancer and postoperative adjuvant chemotherapy', 'colorectal cancer patients with nutritional risk receiving postoperative adjuvant chemotherapy']","['Oral nutritional supplements', 'control group only received dietary guidance', 'dietary guidance and oral nutritional supplements (2092 kJ/day, whole protein enteral nutrition', 'oral nutritional supplementation (ONS', 'ONS', 'oral nutritional supplementation']","['quality of life', 'nutritional status and quality of life', 'body weight and BMI', 'body weight', 'Anthropometric measurements (body weight, body mass index [BMI', 'anthropometric measurements and nutrition-related laboratory tests', 'gastrointestinal function and quality of life', ' upper arm circumference, gripping power of the dominant hand, triceps skin fold), nutrition-related laboratory tests (hemoglobin, albumin, prealbumin, total cholesterol, triglyceride), gastrointestinal function scores and quality of life (evaluated by EuroQol five dimensions questionnaire']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0456646', 'cui_str': 'kJ/day'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}]",43.0,0.042548,No significant differences of other anthropometric measurements and nutrition-related laboratory tests were found between the two groups (all P >0.05).,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200093, China.'}, {'ForeName': 'G X', 'Initials': 'GX', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, Nanfang Hospital of Nanfang Medical University, Guangzhou, Guangdong 510920, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, The Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China.""}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Cui', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20190724-00287'] 2502,32521977,[Application of convolutional neural network to risk evaluation of positive circumferential resection margin of rectal cancer by magnetic resonance imaging].,"Objective: To explore the feasibility of using faster regional convolutional neural network (Faster R-CNN) to evaluate the status of circumferential resection margin (CRM) of rectal cancer in the magnetic resonance imaging (MRI). Methods: This study was registered in the Chinese Clinical Trial Registry (ChiCTR-1800017410). Case inclusion criteria: (1) the positive area of CRM was located between the plane of the levator ani, anal canal and peritoneal reflection; (2) rectal malignancy was confirmed by electronic colonoscopy and histopathological examination; (3) positive CRM was confirmed by postoperative pathology or preoperative high-resolution MRI. Exclusion criteria: patients after neoadjuvant therapy, recurrent cancer after surgery, poor quality images, giant tumor with extensive necrosis and tissue degeneration, and rectal tissue construction changes in previous pelvic surgery. According to the above criteria, MRI plain scan images of 350 patients with rectal cancer and positive CRM in The Affiliated Hospital of Qingdao University from July 2016 to June 2019 were collected. The patients were classified by gender and tumor position, and randomly assigned to the training group (300 cases) and the validation group (50 cases) at a ratio of 6:1 by computer random number method. The CRM positive region was identified on the T2WI image using the LabelImg software. The identified training group images were used to iteratively train and optimize parameters of the Faster R-CNN model until the network converged to obtain the best deep learning model. The test set data were used to evaluate the recognition performance of the artificial intelligence platform. The selected indicators included accuracy, sensitivity, positive predictive value, receiver operating characteristic (ROC) curves, areas under the ROC curves (AUC), and the time taken to identify a single image. Results: The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CRM status determined by the trained Faster R-CNN artificial intelligence approach were 0.884, 0.857, 0.898, 0.807, and 0.926, respectively; the AUC was 0.934 (95% CI: 91.3% to 95.4%). The Faster R-CNN model's automatic recognition time for a single image was 0.2 s. Conclusion: The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by in-situ tumor invasion and has the application value of preliminary screening.",2020,"The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by in-situ tumor invasion and has the application value of preliminary screening.","['350 patients with rectal cancer and positive CRM in The Affiliated Hospital of Qingdao University from July 2016 to June 2019 were collected', 'Exclusion criteria: patients after neoadjuvant therapy, recurrent cancer after surgery, poor quality images, giant tumor with extensive necrosis and tissue degeneration, and rectal tissue construction changes in previous pelvic surgery']","['faster regional convolutional neural network (Faster R-CNN', 'magnetic resonance imaging (MRI', 'convolutional neural network', 'magnetic resonance imaging']","['accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the CRM status determined by the trained Faster R-CNN artificial intelligence approach', 'accuracy, sensitivity, positive predictive value, receiver operating characteristic (ROC) curves, areas under the ROC curves (AUC), and the time taken to identify a single image', ""Faster R-CNN model's automatic recognition time""]","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0549379', 'cui_str': 'Recurrent cancer'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",350.0,0.035935,"The artificial intelligence model based on Faster R-CNN for the identification and segmentation of CRM-positive MRI images of rectal cancer is established, which can complete the risk assessment of CRM-positive areas caused by in-situ tumor invasion and has the application value of preliminary screening.","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'X X', 'Initials': 'XX', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Shandong Key Laboratory of Digital Medicine and Computer Assisted Surgery, Qingdao, Shandong 266003, China.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20191023-00460'] 2503,32522040,Goal achievement and adaptive goal adjustment in a behavioral intervention for participants with prediabetes.,"Participants with prediabetes were supported to achieve and maintain weight loss with a stage-based behavior change group program named PREview behavior Modification Intervention Toolbox (PREMIT). The tendency to engage in a process of goal adjustment was examined in relation to PREMIT attendance. Analyses were based on 1857 participants who had achieved ⩾8percent weight loss. Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance. Instead, results suggested that when unsure about reaching an intervention goal, participants were more likely to engage in a process of goal adjustment, possibly lessening distress due to potentially unachievable goals, either weight loss or maintenance.",2020,Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance.,"['participants with prediabetes', '1857 participants who had achieved ⩾8percent weight loss', 'Participants with prediabetes']",['PREview behavior Modification Intervention Toolbox (PREMIT'],['weight loss or maintenance'],"[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",1857.0,0.0240008,Tendency to engage in a process of goal adjustment appeared not to be influenced by PREMIT attendance.,"[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Huttunen-Lenz', 'Affiliation': 'University of Education Schwäbisch Gmünd, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'University of Stuttgart, Germany.'}, {'ForeName': 'Pia Siig', 'Initials': 'PS', 'LastName': 'Vestentoft', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meinert Larsen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Adam', 'Affiliation': 'Maastricht University, The Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Macdonald', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simpson', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'University of Navarra, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'University of Navarra, Spain.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Medical University of Sofia, Bulgaria.'}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Martha P', 'Initials': 'MP', 'LastName': 'Silvestre', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'University of Helsinki, Finland.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Jalo', 'Affiliation': 'University of Helsinki, Finland.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Brodie', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Brand-Miller', 'Affiliation': 'The University of Sydney, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schlicht', 'Affiliation': 'University of Stuttgart, Germany.'}]",Journal of health psychology,['10.1177/1359105320925150'] 2504,32522060,Feasibility and acceptability of a nutritional intervention testing the effects of nitrate-rich beetroot juice and folic acid on blood pressure in Tanzanian adults with elevated blood pressure.,"Sub-Saharan African countries are experiencing an alarming increase in hypertension prevalence. This study evaluated the feasibility and acceptability of nitrate-rich beetroot and folate supplementation, alone or combined, for the reduction of blood pressure (BP) in Tanzanian adults with elevated BP. This was a three-arm double-blind, placebo-controlled, parallel randomised clinical trial. Forty-eight participants were randomised to one of three groups to follow a specific 60-day intervention which included a: (1) combined intervention (beetroot juice + folate), (2) single intervention (beetroot juice + placebo), and (3) control group (nitrate-depleted beetroot juice + placebo). Forty-seven participants (age: 50-70 years) completed the study. The acceptability of the interventions was high. Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms. This study provides important information for the design of high-nitrate interventions to reduce BP in Sub-Saharan African countries.",2020,Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms.,"['Tanzanian adults with elevated BP', 'Tanzanian adults with elevated blood pressure', 'Forty-seven participants (age: 50-70\u2009years) completed the study', 'Forty-eight participants', 'Sub-Saharan African countries']","['nitrate-rich beetroot and folate supplementation', 'specific 60-day intervention which included a: (1) combined intervention (beetroot juice\u2009+\u2009folate), (2) single intervention (beetroot juice\u2009+\u2009placebo), and (3) control group (nitrate-depleted beetroot juice\u2009+\u2009placebo', 'nitrate-rich beetroot juice and folic acid', 'placebo']","['blood pressure', 'nitrate and folate concentrations in plasma and saliva samples', 'blood pressure (BP', 'hypertension prevalence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0454695', 'cui_str': 'African country'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C4551652', 'cui_str': 'Folate supplementation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",48.0,0.137876,Self-reported compliance to the interventions was more than 90% which was confirmed by the significant increase in nitrate and folate concentrations in plasma and saliva samples in the treatment arms.,"[{'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kandhari', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhakar', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fostier', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koehl', 'Affiliation': 'Human Nutrition Research Centre, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Rogathi', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Blossom C M', 'Initials': 'BCM', 'LastName': 'Stephan', 'Affiliation': 'Institute of Mental Health, The University of Nottingham Medical School, Nottingham, UK.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Gray', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Haule', 'Affiliation': 'District Medical Officer, Hai District Hospital, Bomangombe, Tanzania.'}, {'ForeName': 'Stella-Maria', 'Initials': 'SM', 'LastName': 'Paddick', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Kilimanjaro Christian Medical University College, Tanzania, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, UK.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': ""School of Life Sciences, Queen's Medical Centre, The University of Nottingham Medical School, Nottingham, UK.""}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1776226'] 2505,32522066,"Refined Deep Seawater Improves Serum Lipid Profile in Hypercholesterolemia: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.","Deep seawater (DSW) has been investigated for its lipid-lowering effects, but clinical evidence is still far from conclusive. Therefore, this study was conducted to examine the effects of refined DSW (RDSW) on hypercholesterolemia. In this randomized, double-blind, placebo-controlled trial, 78 Korean participants were randomized to either an RDSW group that drank RDSW for 8 weeks or a placebo group. Clinical laboratory information was collected from all subjects at 0, 4, and 8 weeks. Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study. Stratified analysis of both groups revealed a significant reduction of TC in the moderately high TC subgroup. However, only the RDSW exhibited a significant decline of LDL-c in the high LDL-c subgroup. In addition, lipoprotein(a) decreased significantly in the RDSW group, but not in the placebo. RDSW did not affect other lipid profiles, including high-density lipoprotein cholesterol (HDL-c), triglyceride, free fatty acid, apolipoproteins, and other markers including inflammation marker, hematological parameters, blood and urine chemistry, and vital signs. RDSW improved lipid profiles by decreasing TC and LDL-c while maintaining HDL-c levels in people with hypercholesterolemia.",2020,"Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study.","['people with hypercholesterolemia', 'Hypercholesterolemia', '78 Korean participants']","['refined DSW (RDSW', 'Placebo', 'RDSW group that drank RDSW', 'placebo']","['high-density lipoprotein cholesterol (HDL-c), triglyceride, free fatty acid, apolipoproteins, and other markers including inflammation marker, hematological parameters, blood and urine chemistry, and vital signs', 'total cholesterol (TC', 'low-density lipoprotein cholesterol (LDL-c', 'LDL-c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",78.0,0.384953,"Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study.","[{'ForeName': 'Min-Jee', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine of Korean Medicine, Dongguk University, Goyang, Korea.'}, {'ForeName': 'Chi-Yeon', 'Initials': 'CY', 'LastName': 'Lim', 'Affiliation': 'Department of Biostatistics, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Kyu-Shik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacology and Intractable Disease Research Center, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Kyung-Soo', 'Initials': 'KS', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology and Intractable Disease Research Center, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Hojun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine of Korean Medicine, Dongguk University, Goyang, Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4658'] 2506,32522090,Decision Regret among Informal Caregivers Making Housing Decisions for Older Adults with Cognitive Impairment: A Cross-Sectional Analysis.,"Background . Informal caregivers are regularly faced with difficult housing decisions for older adults with cognitive impairment. They often regret the decision they made. We aimed to identify factors associated with decision regret among informal caregivers engaging in housing decisions for cognitively impaired older adults. Methods . We performed a secondary analysis of cross-sectional data collected from a cluster-randomized trial. Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults. Decision regret was assessed after caregivers' enrollment in the study using the Decision Regret Scale (DRS), scored from 0 to 100. We used a conceptual framework of potential predictors of regret to identify independent variables. We performed multilevel analyses using a mixed linear model by estimating fixed effects (β) and 95% confidence intervals (CIs). Results . The mean (SD) DRS score of 296 informal caregivers (mean [SD] age, 62 [12] years) was 12.4 (18.4). Factors associated with less decision regret were having a college degree compared to primary education (β [95% CI]: -11.14 [-18.36, -3.92]), being married compared to being single (-5.60 [-10.05, -1.15]), informal caregivers' perception that a joint process occurred (-0.14 [-0.25, -0.02]), and older adults' not having a specific housing preference compared to preferring to stay at home (-4.13 [-7.40, -0.86]). Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). Limitations . Our analysis may not illustrate all predictors of decision regret among informal caregivers. Conclusions . Our findings will allow risk-mitigation strategies for informal caregivers at risk of experiencing regret.",2020,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","['Older Adults with Cognitive Impairment', 'older adults with cognitive impairment', 'Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults', 'cognitively impaired older adults']",[],"['mean (SD) DRS score', 'decision regret', ""informal caregivers' perception that a joint process"", 'higher burden of care', 'Decision regret', 'higher decisional conflict', 'Decision Regret Scale (DRS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.118618,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Elidor', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ben Charif', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20925368'] 2507,32522095,Loading doses of ticagrelor versus clopidogrel in preventing periprocedural myocardial infarction in Asian patients with acute coronary syndrome.,"BACKGROUND Periprocedural myocardial infarction is a common complication following percutaneous coronary intervention. The present study was conducted with an aim to compare the safety and efficacy of loading doses of ticagrelor versus clopidogrel in preventing periprocedural myocardial infarction in Asian patients with acute coronary syndrome undergoing elective percutaneous coronary intervention. METHODS A total of 114 patients with acute coronary syndrome undergoing elective percutaneous coronary intervention were assigned to clopidogrel group (n = 57, the loading and maintenance doses were 300 and 75 mg qd for clopidogrel, and 300 and 100 mg qd for aspirin), or ticagrelor group (n = 57, the loading and maintenance doses were 180 and 90 mg bid for ticagrelor, and 300 and 100 mg qd for aspirin). Cardiac biomarkers were measured before, 8 hours, and 24 hours after percutaneous coronary intervention. The percutaneous coronary intervention-related periprocedural myocardial infarction was defined according to the fourth universal definition of myocardial infarction (2018). RESULTS The overall incidence of percutaneous coronary intervention-related periprocedural myocardial infarction was 21.1%. The ticagrelor group showed a significantly lower incidence of periprocedural myocardial infarction (12.3% vs 29.8%, p = 0.022) and numerically lower bleeding events (3.5% vs 8.8%, p = 0.242) as compared with clopidogrel group. No patient had major adverse cardiovascular events during the 1-month follow-up. The levels of high-sensitivity C-reactive protein did not differ significantly between the two groups (p > 0.05), indicating that the benefits of ticagrelor were not from its anti-inflammatory effects. Multivariable analysis showed that the use of ticagrelor (odds ratio: 0.50; 95% confidence interval: 0.29-0.87; p = 0.014) and number of stents (odds ratio: 2.75; 95% confidence interval: 1.25-6.06; p = 0.012) were independent predictors of periprocedural myocardial infarction. CONCLUSION Pretreatment with a loading dose of ticagrelor seems to be superior in reducing the incidence of percutaneous coronary intervention-related periprocedural myocardial infarction in Asian patients with acute coronary syndrome as compared with clopidogrel.",2020,Multivariable analysis showed that the use of ticagrelor (odds ratio: 0.50; 95% confidence interval: 0.29-0.87; p = 0.014) and number of stents (odds ratio: 2.75; 95% confidence interval: 1.25-6.06; p = 0.012),"['114 patients with acute coronary syndrome undergoing elective percutaneous coronary intervention', 'Asian patients with acute coronary syndrome undergoing elective percutaneous coronary intervention', 'Asian patients with acute coronary syndrome']","['ticagrelor versus clopidogrel', 'percutaneous coronary intervention', 'clopidogrel group (n\u2009=\u200957, the loading and maintenance doses were 300 and 75\u2009mg qd for clopidogrel, and 300 and 100\u2009mg qd for aspirin', 'clopidogrel', 'ticagrelor group (n\u2009=\u200957, the loading and maintenance doses were 180 and 90\u2009mg bid for ticagrelor, and 300 and 100\u2009mg qd for aspirin', 'ticagrelor']","['overall incidence of percutaneous coronary intervention-related periprocedural myocardial infarction', 'levels of high-sensitivity C-reactive protein', 'number of stents', 'bleeding events', 'safety and efficacy', 'major adverse cardiovascular events', 'Cardiac biomarkers', 'periprocedural myocardial infarction']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449958', 'cui_str': 'Number of stent(s)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",114.0,0.0271782,Multivariable analysis showed that the use of ticagrelor (odds ratio: 0.50; 95% confidence interval: 0.29-0.87; p = 0.014) and number of stents (odds ratio: 2.75; 95% confidence interval: 1.25-6.06; p = 0.012),"[{'ForeName': 'Ya-Ru', 'Initials': 'YR', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Zheng-Kai', 'Initials': 'ZK', 'LastName': 'Xue', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kang-Yin', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ling-Xia', 'Initials': 'LX', 'LastName': 'Xu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Wei-Ding', 'Initials': 'WD', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Hua-Yue', 'Initials': 'HY', 'LastName': 'Tao', 'Affiliation': 'The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong-', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing-Jin', 'Initials': 'JJ', 'LastName': 'Che', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jia-Rui', 'Initials': 'JR', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Peng-', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China.'}]",Perfusion,['10.1177/0267659120927857'] 2508,32522106,Association of high TUBB3 with resistance to adjuvant docetaxel-based chemotherapy in gastric cancer: translational study of ITACA-S.,"BACKGROUND No predictive markers for chemotherapy activity have been validated in gastric cancer (GC). The potential value of class III β-tubulin (TUBB3) as biomarker for prognosis and resistance to taxane-based therapy was reported. METHODS We analyzed GC samples of patients enrolled in the Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S), a randomized adjuvant study comparing 5-fluorouracil/leucovorin (5-FU/LV) and docetaxel-based sequential chemotherapy. TUBB3 was quantitated by selected reaction monitoring mass spectrometry and patients were stratified using a threshold of 750 attomoles per microgram (amol/µg). Cox proportional modeling and Kaplan-Meier survival analysis were used to assess the impact of TUBB3 expression on overall survival (OS) and disease-free survival. RESULTS Patients with TUBB3 protein levels >750 and <750 amol/µg were 21.9% and 78.1%, respectively, and were well-balanced between treatment arms. TUBB3 protein levels were not prognostic. Whereas no survival differences according to the 2 arms were observed in the subgroup with low TUBB3 expression (5-year OS 47% vs 40%; p = 0.44), patients with high TUBB3 had a clinically meaningful poorer OS when receiving docetaxel-based versus 5-FU/LV chemotherapy (5-year OS 31% vs 54%; p = 0.09), with a statistically significant interaction between TUBB3 and treatment ( p = 0.049). CONCLUSIONS The quantification of TUBB3 might be considered as a negative predictive biomarker of benefit from taxane-based therapy in GC. Studies are needed to evaluate its role in the neoadjuvant setting.",2020,TUBB3 protein levels were not prognostic.,"['gastric cancer (GC', 'gastric cancer', 'patients enrolled in the Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S']","['5-fluorouracil/leucovorin (5-FU/LV) and docetaxel-based sequential chemotherapy', 'docetaxel-based chemotherapy', '5-FU/LV chemotherapy', 'class III β-tubulin (TUBB3']","['TUBB3 expression on overall survival (OS) and disease-free survival', 'survival differences', 'TUBB3 protein levels', 'TUBB3', 'low TUBB3 expression']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0041348', 'cui_str': 'Tubulin'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0306529,TUBB3 protein levels were not prognostic.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'NantOmics, Rockville, MD.'}, {'ForeName': 'Daniel V T', 'Initials': 'DVT', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'NantOmics, Rockville, MD.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Sellappan', 'Affiliation': 'NantOmics, Rockville, MD.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'NantOmics, Rockville, MD.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Department of Medical Statistics, Biometry, and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pellegrinelli', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Giommoni', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera-Università Careggi, Firenze, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Aitini', 'Affiliation': 'Medical Oncology, Ospedale di Suzzara, Mantova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Spada', 'Affiliation': 'Gastrointestinal Oncology and Neuroendocrine Tumors, Istituto Oncologico Europeo, Milan, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera ""San Carlo,"" Potenza, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marchet', 'Affiliation': 'Surgery, Oncology and Gastroenterology Department, Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pucci', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Parma, Parma, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Oncology Department, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamberi', 'Affiliation': 'Oncology Department, AUSL Romagna, Ravenna, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Pressiani', 'Affiliation': 'Medical Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Sanna', 'Affiliation': ""Medical Oncology, Istituto Ospedaliero dell'Università di Sassari, Sassari, Italy.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera ""Carlo Poma,"" Mantova, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Mosconi', 'Affiliation': 'Medical Oncology, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Bolzoni', 'Affiliation': 'Medical Oncology, Presidio Ospedaliero ""Serbelloni"" di Gorgonzola, Melegnano, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Medical Oncology, Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Landi', 'Affiliation': 'Medical Oncology, Presidio Ospedaliero di Livorno, Livorno, Italy.'}, {'ForeName': 'Hector Josè', 'Initials': 'HJ', 'LastName': 'Soto Parra', 'Affiliation': 'Medical Oncology, Policlinico Vittorio Emanuele, Presidio Gaspare Rodolico, Catania, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Oncology-Hematology Department, Ospedale Civile ""Guglielmo da Saliceto,"" Piacenza, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Hembrough', 'Affiliation': 'NantOmics, Rockville, MD.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Tumori,['10.1177/0300891620930803'] 2509,32522155,Cardiovascular risk factor mapping and distribution among adults in Mukono and Buikwe districts in Uganda: small area analysis.,"BACKGROUND Sub-Saharan Africa (SSA) is experiencing an increasing burden of Cardiovascular Diseases (CVDs). Modifiable risk factors including hypertension, diabetes, obesity, central obesity, sedentary behaviours, smoking, poor diet (characterised by inadequate vegetable and fruit consumption), and psychosocial stress are attributable to the growing burden of CVDs. Small geographical area mapping and analysis of these risk factors for CVD is lacking in most of sub-Saharan Africa and yet such data has the potential to inform monitoring and exploration of patterns of morbidity, health-care use, and mortality, as well as the epidemiology of risk factors. In the current study, we map and describe the distribution of the CVD risk factors in 20 parishes in two neighbouring districts in Uganda. METHODS A baseline survey benchmarking a type-2 hybrid stepped wedge cluster randomised trial design was conducted in December 2018 and January 2019. A sample of 4372 adults aged 25-70 years was drawn from 3689 randomly selected households across 80 villages in 20 parishes in Mukono and Buikwe districts in Uganda. Descriptive statistics and generalized linear modelling controlled for clustering were conducted for this analysis in Stata 13.0, and a visual map showing risk factor distribution developed in QGIS. RESULTS Mapping the prevalence of selected CVD risk factors indicated substantial gender and small area geographic heterogeneity which was masked on aggregate analysis. Patterns and clustering were observed for hypertension, physical inactivity, smoking, alcohol consumption and risk factor combination. Prevalence of unhealthy diet was very high across all parishes with no significant observable differences across areas. CONCLUSION Modifiable cardiovascular risk factors are common in this low-income context. Moreover, across small area geographic setting, it appears significant differences in distribution of risk factors exist. These differences suggest that underlying drivers such as sociocultural, environmental and economic determinants may be promoting or inhibiting the observed risk factor prevalences which should be further explored. In addition, the differences emphasize the value of small geographical area mapping and analysis to inform more targeted risk reduction interventions.",2020,"Prevalence of unhealthy diet was very high across all parishes with no significant observable differences across areas. ","['adults in Mukono and Buikwe districts in Uganda', 'December 2018 and January 2019', '20 parishes in two neighbouring districts in Uganda', '4372 adults aged 25-70\u2009years was drawn from 3689 randomly selected households across 80 villages in 20 parishes in Mukono and Buikwe districts in Uganda']",[],"['hypertension, physical inactivity, smoking, alcohol consumption and risk factor combination', 'hypertension, diabetes, obesity, central obesity, sedentary behaviours, smoking, poor diet']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}]",[],"[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0588012', 'cui_str': 'Diet poor'}]",4372.0,0.0557498,"Prevalence of unhealthy diet was very high across all parishes with no significant observable differences across areas. ","[{'ForeName': 'Geofrey', 'Initials': 'G', 'LastName': 'Musinguzi', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda. mgeof@musph.ac.ug.'}, {'ForeName': 'Rawlance', 'Initials': 'R', 'LastName': 'Ndejjo', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Ssinabulya', 'Affiliation': 'Department of Medicine, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Bastiaens', 'Affiliation': 'Department of Primary and Interdisciplinary care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Marwijk', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex University Medical School, Sussex, UK.'}, {'ForeName': 'Rhoda K', 'Initials': 'RK', 'LastName': 'Wanyenze', 'Affiliation': 'Department of Disease Control and Environmental Health, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01573-3'] 2510,32522156,Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial.,"BACKGROUND Loss of resistance (LOR) technique is a widely used method to identify the epidural space. However, cases of inadequate epidural anesthesia in cesarean section were frequently reported. Also, the success rate of epidural anesthesia with LOR technique varied depending on the proficiency of the practitioner. The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section for novices or clinicians with recent gap in experience. METHODS Pregnant women scheduled for elective cesarean section were randomly allocated to two groups. Groups were classified based on the methods used for identifying the epidural space: the LOR group (group L) and the LOR with epidural electrical stimulation group (group E). Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section. In the group E, a RegionalStim® conductive catheter was inserted through the Tuohy needle, and the guidewire passing through the catheter was connected to a peripheral nerve stimulator. The intensity of the stimulation was gradually increased from 0.25 mA to 1.5 mA until paresthesia was elicited and radiated. We assessed the success of epidural anesthesia (complete success, partial success or failure). Other clinical parameters including maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events were compared between the two groups. RESULTS Except for 6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E). The demographic data showed no difference between the two groups. There was no adverse event resulted from electrical stimulation. The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively). The other clinical parameters showed no differences between the two groups. CONCLUSION In addition to the conventional LOR technique, identifying epidural spaces using electrical stimulation led to better outcomes without additional risks for novices as well as clinicians with recent gap in experience. TRIAL REGISTRATION This study was retrospectively registered in the ClinicalTrials.gov Registry (NCT03443466) on February 23, 2018.",2020,"The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively).","['Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section', '6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E', 'cesarean section for novices or clinicians with recent gap in experience', 'epidural anesthesia for cesarean section', 'Pregnant women scheduled for elective cesarean section']","['electrical stimulation', 'conventional LOR technique', 'LOR with epidural electrical stimulation']","['higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction', 'success of epidural anesthesia (complete success, partial success or failure', 'efficacy and safety', 'intensity of the stimulation', 'maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events']","[{'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0587268', 'cui_str': 'Loss of resistance technique'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0014537', 'cui_str': 'Structure of epidural space'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",54.0,0.087104,"The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively).","[{'ForeName': 'Young Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Hyo Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Chung Hun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Mi Kyoung', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea.'}, {'ForeName': 'Sang Sik', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul, 08308, South Korea. clonidine@empal.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01063-1'] 2511,32522171,"A comparison among PCNL, Miniperc and Ultraminiperc for lower calyceal stones between 1 and 2 cm: a prospective, comparative, multicenter and randomised study.","BACKGROUND Conventional Percutaneous Lithotripsy (PCNL) has been an effective, successful and easy approach for especially > 1 cm sized calyceal stones however risks of complications and nephron loss are inevitable. Our aim is to compare the efficacy and safety of PCNL, MiniPerc (MP) and UltraMiniPerc (UMP) for lower calyceal stones between 1 and 2 cm with a multicenter prospective randomized study. METHODS Between January 2015 and June 2018, 132 consecutive patients with single lower calyceal stone were enrolled. Patients were randomized in three groups; A: PCNL; B: MP; C: UMP. 44 patients for the Group A, 47 for Group B and 41 for Group C. Exclusion criterias were the presence of coagulation impairments, age of < 18 or > 75, presence of infection or serious comorbidities. Patients were controlled with computerized tomography scan after 3 months. A negative CT or an asymptomatic patient with stone fragments < 3 mm size were the criteria to assess the stone-free status. Patient characteristics, stone free rates (SFR) s, complications and re-treatment rates were analyzed. RESULTS The mean stone size were 16.38, 16.82 and 15.23 mm respectively in Group A, B and C(p = 0.34). The overall SFR was significantly higher in Group A (86.3%) and B (82.9%) as compared to Group C (78%)(p < 0.05). The re-treatment rate was significantly higher in Group C (12.1%) and complication rates was higher in Group A (13.6%) as compared to others(p < 0.05). The hospitalization was significantly shorter in Group C compared to Group A (p = 0.04). CONCLUSIONS PCNL and MP showed higher efficacy than UMP to obtain a better SFR. Auxiliary and re-treatment rates were higher in UMP. On the other hand for such this kind of stones PCNL had more complications. Overall evaluation favors MP as a better indication in stones 1-2 cm size.",2020,"The mean stone size were 16.38, 16.82 and 15.23 mm respectively in Group A, B and C(p = 0.34).","['Between January 2015 and June 2018, 132 consecutive patients with single lower calyceal stone were enrolled', '44 patients for the Group A, 47 for Group B and 41 for Group C. Exclusion criterias were the presence of coagulation impairments, age of <\u200918 or\u2009>\u200975, presence of infection or serious comorbidities']","['PCNL, Miniperc and Ultraminiperc', 'PCNL, MiniPerc (MP) and UltraMiniPerc (UMP', 'PCNL; B: MP; C: UMP', 'Conventional Percutaneous Lithotripsy (PCNL']","['complication rates', 'mean stone size', 'hospitalization', 're-treatment rate', 'SFR) s, complications and re-treatment rates', 'Patient characteristics, stone free rates', 'overall SFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449970', 'cui_str': 'Presence of infection'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",132.0,0.0494778,"The mean stone size were 16.38, 16.82 and 15.23 mm respectively in Group A, B and C(p = 0.34).","[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bozzini', 'Affiliation': 'Department of Urology, ASST Valle Olona Busto Arsizio, Varese, Italy.'}, {'ForeName': 'Tahsin Batuhan', 'Initials': 'TB', 'LastName': 'Aydogan', 'Affiliation': 'Department of Urology, University of Modena and Reggio Emilia, Modena, Italy. drbatu@hotmail.com.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Urology, Spital Limmattal, Schlieren, Switzerland.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Sighinolfi', 'Affiliation': 'Department of Urology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Besana', 'Affiliation': 'Department of Urology, ASST Valle Olona Busto Arsizio, Varese, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Calori', 'Affiliation': 'Department of Urology, ASST Valle Olona Busto Arsizio, Varese, Italy.'}, {'ForeName': 'Berti', 'Initials': 'B', 'LastName': 'Lorenzo', 'Affiliation': 'Department of Urology, ASST Valle Olona Busto Arsizio, Varese, Italy.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Govorov', 'Affiliation': 'Department of Urology, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia.'}, {'ForeName': 'Dmitry Y', 'Initials': 'DY', 'LastName': 'Pushkar', 'Affiliation': 'Department of Urology, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia.'}, {'ForeName': 'Giovannalberto', 'Initials': 'G', 'LastName': 'Pini', 'Affiliation': 'Department of Urology, San Raffaele Turro Hospital, Milan, Italy.'}, {'ForeName': 'Antonio Luigi', 'Initials': 'AL', 'LastName': 'Pastore', 'Affiliation': 'Department of Urology, ICOT Latina, Latina, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Romero-Otero', 'Affiliation': 'Department of Urology, Hospital Universitario 12 de Octobre, Madrid, Spain.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Rocco', 'Affiliation': 'Department of Urology, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Buizza', 'Affiliation': 'Department of Urology, ASST Valle Olona Busto Arsizio, Varese, Italy.'}]",BMC urology,['10.1186/s12894-020-00636-z'] 2512,32522198,Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction (METOCARD-CNIC randomized clinical trial substudy).,"BACKGROUND We aimed to evaluate the effect of early intravenous metoprolol treatment, microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV) remodeling on the evolution of infarct and remote zone circumferential strain after acute anterior ST-segment elevation myocardial infarction (STEMI) with feature-tracking cardiovascular magnetic resonance (CMR). METHODS A total of 191 patients with acute anterior STEMI enrolled in the METOCARD-CNIC randomized clinical trial were evaluated. LV infarct zone and remote zone circumferential strain were measured with feature-tracking CMR at 1 week and 6 months after STEMI. RESULTS In the overall population, the infarct zone circumferential strain significantly improved from 1 week to 6 months after STEMI (- 8.6 ± 9.0% to - 14.5 ± 8.0%; P < 0.001), while no changes in the remote zone strain were observed (- 19.5 ± 5.9% to - 19.2 ± 3.9%; P = 0.466). Patients who received early intravenous metoprolol had significantly more preserved infarct zone circumferential strain compared to the controls at 1 week (P = 0.038) and at 6 months (P = 0.033) after STEMI, while no differences in remote zone strain were observed. The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001). In patients who developed adverse LV remodeling (defined as ≥ 20% increase in LV end-diastolic volume) remote zone circumferential strain worsened between 1 week and 6 months after STEMI (P = 0.036), while in the absence of adverse LV remodeling no significant changes in remote zone strain were observed. CONCLUSIONS Regional LV circumferential strain with feature-tracking CMR allowed comprehensive evaluation of the sequelae of an acute STEMI treated with primary percutaneous coronary intervention and demonstrated long-lasting cardioprotective effects of early intravenous metoprolol. TRIAL REGISTRATION ClinicalTrials.gov, NCT01311700. Registered 8 March 2011 - Retrospectively registered.",2020,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","['191 patients with acute anterior STEMI enrolled', 'Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction']",['metoprolol'],"['preserved infarct zone circumferential strain', 'LV infarct zone and remote zone circumferential strain', 'adverse LV remodeling', 'remote zone strain', 'LV end-diastolic volume) remote zone circumferential strain', 'infarct zone circumferential strain', 'MVO or IMH', 'microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",191.0,0.133452,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Greif', 'Affiliation': 'Faculty of Medicine University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nina Ajmone', 'Initials': 'NA', 'LastName': 'Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. v.delgado@lumc.nl.'}]",Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance,['10.1186/s12968-020-00638-8'] 2513,32522244,Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra).,"BACKGROUND Syphilis is a sexually and vertically transmitted infection caused by the bacteria Treponema pallidum for which there are few proven alternatives to penicillin for treatment. For pregnant women infected with syphilis, penicillin is the only WHO-recommended treatment that will treat the mother and cross the placenta to treat the unborn infant and prevent congenital syphilis. Recent shortages, national level stockouts as well as other barriers to penicillin use call for the urgent identification of alternative therapies to treat pregnant women infected with syphilis. METHODS This prospective, randomized, non-comparative trial will enroll non-pregnant women aged 18 years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16. Women will be a, domized in a 2:1 ratio to receive the oral third generation cephalosporin cefixime at a dose of 400 mg two times per day for 10 days (n = 140) or benzathine penicillin G 2.4 million units intramuscularly based on the stage of syphilis infection (n = 70). RPR titers will be collected at enrolment, and at three, six, and nine months following treatment. Participants experiencing a 4-fold (2 titer) decline by 6 months will be considered as having an adequate or curative treatment response. DISCUSSION Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis. TRIAL REGISTRATION Trial identifier: www.Clinicaltrials.gov, NCT03752112. Registration Date: November 22, 2018.",2020,"DISCUSSION Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis. ","['pregnant women infected with', 'pregnant women infected with syphilis', 'non-pregnant women', 'pregnant women with active syphilis', 'pregnant women aged 18\u2009years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16', 'Participants experiencing a 4-fold (2 titer) decline by 6\u2009months will be considered as having an adequate or curative treatment response', 'non-pregnant women in Brazil (CeBra']","['benzathine penicillin', 'cefixime', 'cephalosporin cefixime', 'syphilis, penicillin']",['RPR titers'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0030829', 'cui_str': 'benzathine benzylpenicillin'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}]","[{'cui': 'C0201405', 'cui_str': 'Rapid plasma reagin test'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.230271,"DISCUSSION Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis. ","[{'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Taylor', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland. mtaylor@who.int.'}, {'ForeName': 'Edna Oliveira', 'Initials': 'EO', 'LastName': 'Kara', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Maria Alix Leite', 'Initials': 'MAL', 'LastName': 'Araujo', 'Affiliation': 'University of Fortaleza (UNIFOR), Fortaleza, Brazil.'}, {'ForeName': 'Mariangela Freitas', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Post-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Angelica Espinosa', 'Initials': 'AE', 'LastName': 'Miranda', 'Affiliation': 'Federal University of Espírito Santo, Vitória, Brazil.'}, {'ForeName': 'Ivo Castelo', 'Initials': 'IC', 'LastName': 'Branco Coelho', 'Affiliation': 'Federal University of Ceará, Ambulatório de IST do Hospital Universitário da Universidade Federal do Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Maria Luiza', 'Initials': 'ML', 'LastName': 'Bazzo', 'Affiliation': 'Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Gerson Fernando', 'Initials': 'GF', 'LastName': 'Mendes Pereira', 'Affiliation': 'Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Pereira Giozza', 'Affiliation': 'Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.'}, {'ForeName': 'Ximena Pamela Díaz', 'Initials': 'XPD', 'LastName': 'Bermudez', 'Affiliation': 'University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Maeve B', 'Initials': 'MB', 'LastName': 'Mello', 'Affiliation': 'University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ndema', 'Initials': 'N', 'LastName': 'Habib', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'My Huong', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Soe Soe', 'Initials': 'SS', 'LastName': 'Thwin', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Broutet', 'Affiliation': 'Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}]",BMC infectious diseases,['10.1186/s12879-020-04980-1'] 2514,32522251,"Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies.","BACKGROUND The interleukin-6 receptor inhibitor sarilumab demonstrated efficacy in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or as monotherapy in patients with moderately to severely active rheumatoid arthritis (RA) with an inadequate response (IR) or intolerant (INT) to methotrexate (MTX) or tumour necrosis factor (TNF)-α inhibitors. This analysis investigated the efficacy and safety of sarilumab in patient subgroups. METHODS Data were included from phase III studies: two placebo-controlled studies of subcutaneous sarilumab 150/200 mg every 2 weeks (q2w) either + MTX in MTX-IR patients (52 weeks) or + csDMARDs in TNF-IR/INT patients (24 weeks), and a monotherapy study of sarilumab 200 mg q2w vs. adalimumab 40 mg q2w in MTX-IR/INT patients (24 weeks). Prespecified and post hoc subgroups included patient demographics, disease characteristics, and prior treatments. Prespecified and post hoc endpoints included clinical, radiographic, and physical function measures, and p values are considered nominal. Safety was assessed during double-blind treatment. RESULTS The superiority of sarilumab (either as monotherapy vs. adalimumab or in combination with csDMARDs vs. placebo + csDMARDs) across clinical endpoints was generally consistent across subgroups defined by patient demographics, disease characteristics, and prior treatments, demonstrating the benefit of sarilumab treatment for a wide range of patient types. Interaction p values of < 0.05 were consistently observed across studies only for baseline anti-cyclic citrullinated peptide antibody (ACPA) status for American College of Rheumatology 20% response, but not American College of Rheumatology 50% or 70% response. Adverse events and worsening laboratory parameters occurred more frequently in sarilumab-treated vs. placebo-treated patients and were more frequent in the small number of patients ≥ 65 years (n = 289) vs. patients < 65 years (n = 1819). Serious infections occurred in six patients aged ≥ 65 years receiving sarilumab, although the incidence of serious infections was generally higher in patients aged ≥ 65 years regardless of treatment. CONCLUSIONS Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed. Sarilumab demonstrated consistent efficacy and safety across a wide range of patients with RA. TRIAL REGISTRATION ClinicalTrials.gov NCT01061736, registered on February 03, 2010; ClinicalTrials.gov NCT01709578, registered on October 18, 2012; ClinicalTrials.gov NCT02332590, registered on January 07, 2015.",2020,"Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed.","['patient subgroups', 'patients with moderately to severely active rheumatoid arthritis (RA) with an inadequate response (IR) or intolerant (INT) to', 'Data were included from phase III studies: two', 'registered on February 03, 2010', 'subpopulations of patients with moderately to severely active rheumatoid arthritis', 'six patients aged ≥']","['subcutaneous sarilumab 150/200\u2009mg every 2\u2009weeks (q2w) either + MTX in MTX-IR patients (52\u2009weeks) or + csDMARDs in TNF-IR/INT', 'methotrexate (MTX) or tumour necrosis factor (TNF)-α inhibitors', 'sarilumab (either as monotherapy vs. adalimumab or in combination with csDMARDs vs. placebo', 'sarilumab 200\u2009mg q2w vs. adalimumab 40\u2009mg q2w in MTX-IR/INT', 'sarilumab in combination with csDMARDs or as monotherapy', 'placebo']","['Safety', 'Adverse events and worsening laboratory parameters', 'Efficacy and safety', 'incidence of serious infections', 'efficacy and safety', 'Serious infections', 'clinical, radiographic, and physical function measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1257890', 'cui_str': 'Group'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.386519,"Apart from ACPA status, there were no consistent signals indicating differential effects of sarilumab in any of the subpopulations assessed.","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA. genovese@stanford.edu.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern and Metroplex Clinical Research Center, Dallas, TX, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Eun-Bong', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'St John', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Mangan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité-University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany.'}]",Arthritis research & therapy,['10.1186/s13075-020-02194-z'] 2515,32522263,ICT-based adherence monitoring in kidney transplant recipients: a randomized controlled trial.,"BACKGROUND Prior studies have explored the use of regular reminders to improve adherence among kidney transplant recipients (KTRs), but none have included real-time alarms about drug dosage, frequency, and interval. In the present study, we aimed to evaluate the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system for increasing medication adherence among Korean KTRs. METHODS In this prospective, multicenter, randomized controlled study, enrolled KTRs were randomized to either the ICT-based centralized monitoring group or control group. The ICT-based centralized monitoring system alerted both patients and medical staff with texts and pill box alarms if there was a missed dose or a dosage/time error. We compared the two groups in terms of medication adherence and transplant outcomes over 6 months, and evaluated patient satisfaction with the ICT-based monitoring system. RESULTS Among 114 enrolled KTRs, 57 were assigned to the ICT-based centralized monitoring group and 57 to the control group. The two groups did not significantly differ in mean adherence at each follow-up visit. The intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes did not differ between the intervention and control groups, or between the intervention group with feedback generation and the intervention group without feedback generation. Patients showed high overall satisfaction with the ICT-based centralized monitoring system, which significantly improved across the study period (p = 0.012). CONCLUSIONS Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs. However, patients were highly satisfied with the system. Our results suggest that the ICT-based centralized monitoring system could be successfully applied in clinical trials. TRIAL REGISTRATION ClinicalTrials.gov, NCT03136588. Registered 20 April 2017 - Retrospectively registered.",2020,"CONCLUSIONS Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs.","['kidney transplant recipients (KTRs', '114 enrolled KTRs', 'kidney transplant recipients', 'Registered 20 April 2017 - Retrospectively registered', 'Korean KTRs']","['ICT-based centralized monitoring system', 'ICT-based centralized monitoring', 'ICT-based centralized monitoring group or control group', 'ICT-based adherence monitoring', 'information and communication technology (ICT)-based centralized monitoring system']","['intrapatient variability of tacrolimus and mycophenolic acid levels, renal function, and adverse transplant outcomes', 'overall satisfaction', 'mean adherence', 'medication adherence and transplant outcomes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0490329,"CONCLUSIONS Due to high baseline adherence, the ICT-based centralized monitoring system did not maximize medication adherence or enhance transplant outcomes among Korean KTRs.","[{'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Biomedical Science and Clinical Trial Center, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jung Ju', 'Initials': 'JJ', 'LastName': 'Seo', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Se-Hee', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Konyang University College of Medicine, Daejeon, South Korea.'}, {'ForeName': 'Jong Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, 41944, South Korea. ylkim@knu.ac.kr.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01146-6'] 2516,32522268,Association of Modic change types and their short tau inversion recovery signals with clinical characteristics- a cross sectional study of chronic low back pain patients in the AIM-study.,"BACKGROUND Modic Changes (MCs, magnetic resonance imaging (MRI) signal changes in the vertebral bone marrow extending from the vertebral endplate) may represent a subgroup of nonspecific chronic low back pain that could benefit from a specific management. The primary aim was to compare clinical characteristics between patients with type 1 versus type 2 MCs. The secondary aim was to explore associations between clinical characteristics and MC related short tau inversion recovery (STIR) signals. METHODS This cross-sectional study used baseline data prospectively collected between 2015 and 2017 on the 180 patients included in the AIM-study (Antibiotics In Modic changes), a randomized controlled trial in a Norwegian hospital out-patient setting of patients with chronic low back pain, a lumbar disc herniation within the last 2 years, low back pain intensity score ≥ 5 (on a 0-10 scale) and current type 1 or type 2 MCs at the previously herniated lumbar disc level. We used prespecified clinical characteristics including self-report measures, physiologic measures and functional measures from clinical history and examination. The diagnostic accuracy of various clinical characteristics to discriminate between patients with type 1 MCs (with or without additional type 2 MCs) and patents with type 2 MCs only (not type 1) were assessed by calculating the area under the receiver-operating curve. We assessed the correlations of clinical characteristics with details of MC related STIR signal increase. RESULTS No clinical characteristic differed between patients with type 1 (n = 118) versus type 2 (but not type 1) (n = 62) MCs. The clinical characteristics showed no/minor differences or no/weak correlations with MC related STIR signal increase. Patients with a positive Springing test (at any lumbar level) had slightly less volume of STIR signal increase than those with a negative test (mean difference 1.3 on a 0-48 scale, 95% CI 0.3 to 2.3). CONCLUSION Clinical characteristics were similar for patients with type 1 MCs and patients with type 2 MCs, and showed no clinically relevant correlations with MC related STIR signal increase. TRIAL REGISTRATION ClinicalTrials.gov NCT02323412, First registered 23 December 2014.",2020,"Patients with a positive Springing test (at any lumbar level) had slightly less volume of STIR signal increase than those with a negative test (mean difference 1.3 on a 0-48 scale, 95% CI 0.3 to 2.3). ","['patients with type 1 versus type 2 MCs', '2015 and 2017 on the 180 patients included in the AIM-study (Antibiotics In Modic changes), a randomized controlled trial in a Norwegian hospital out-patient setting of patients with chronic low back pain, a lumbar disc herniation within the last 2\u2009years, low back pain intensity score\u2009≥\u20095 (on a 0-10 scale) and current type 1 or type 2 MCs at the previously herniated lumbar disc level', 'chronic low back pain patients', 'patients with type 1 MCs (with or without additional type 2 MCs) and patents with type 2 MCs only (not type 1']",[],['volume of STIR signal increase'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]",[],"[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.128798,"Patients with a positive Springing test (at any lumbar level) had slightly less volume of STIR signal increase than those with a negative test (mean difference 1.3 on a 0-48 scale, 95% CI 0.3 to 2.3). ","[{'ForeName': 'Lars Christian Haugli', 'Initials': 'LCH', 'LastName': 'Bråten', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Ullevål, Postbox 4956, Nydalen, 0424, Oslo, Norway. l.c.h.braten@studmed.uio.no.'}, {'ForeName': 'Elina Iordanova', 'Initials': 'EI', 'LastName': 'Schistad', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Anne Julsrud', 'Initials': 'AJ', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.'}, {'ForeName': 'Gunn Hege', 'Initials': 'GH', 'LastName': 'Marchand', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Postbox 3250, Torgarden, NO-7006, Trondheim, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Vetti', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Postbox 4950, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Thomas Istvan', 'Initials': 'TI', 'LastName': 'Kadar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.'}, {'ForeName': 'Jan Sture', 'Initials': 'JS', 'LastName': 'Skouen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University, PO box 4 St. Olavs plass, NO-0130, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Ullevål, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ullevål, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Research and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Ullevål, Postbox 4956, Nydalen, 0424, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03381-4'] 2517,32522273,Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial.,"BACKGROUND Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (IR). Traditional Chinese medicine (TCM) has showed potential benefits in the management of NAFLD. Lingguizhugan decoction (LGZG) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. METHODS/DESIGN This study will be a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 patients with NAFLD will be recruited and randomly assigned to the standard dose LGZG (SLGD) group, low dose LGZG (LLGD) group, or the placebo group based on a ratio of 1:1:1. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the proportions of participants with at least a 1-unit decrease of HOMA-IR from baseline to 12 weeks. Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales. Biological samples will also be collected for future researches on mechanism exploration. DISCUSSION This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern and promote its application in community healthcare centers. In addition, potential mechanisms will be explored based on studies of oral and gut microbiota. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1800014364. Registered on 1 January 2018. The final protocol version was V3.0.",2020,"Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales.","['non-alcoholic fatty liver disease with spleen-yang deficiency pattern', '243 patients with NAFLD']","['LGZG', 'Lingguizhugan decoction (LGZG', 'Traditional Chinese medicine Lingguizhugan decoction treating', 'standard dose LGZG (SLGD) group, low dose LGZG (LLGD', 'Traditional Chinese medicine (TCM', 'placebo']","['proportions of participants with at least a 1-unit decrease of HOMA-IR', 'changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",243.0,0.486143,"Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales.","[{'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Shengfu', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South Wanping Road, Shanghai, 200032, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Peiyong', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South Wanping Road, Shanghai, 200032, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China. jiliver@vip.sina.com.'}, {'ForeName': 'Baocheng', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China. baochliu@shutcm.edu.cn.'}]",Trials,['10.1186/s13063-020-04362-7'] 2518,32522282,Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as ""days alive and out of hospital"" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death. TRIAL DESIGN This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. PARTICIPANTS 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals. INCLUSION CRITERIA • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily. INTERVENTION AND COMPARATOR Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) (""Days alive and out of hospital"") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No). BLINDING (MASKING) Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) This study requires 226 patients randomised 1:1 with 113 in each group. TRIAL STATUS Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020). TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms).,"['Men or non-fertile women', 'Neurogenic hearing loss •', 'Hospitalized ≤48 hours •', 'Psoriasis •', 'Age≥ 18 years •', '226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals', 'Hospitalised Patients With COVID-19 (ProPAC-COVID', 'Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments •', '226 patients randomised 1:1 with 113 in each group', 'Protocol version 1.8, from April 16, 2020', 'Myasthenia gravis •', 'Exclusion criteria']","['standard care', 'Placebo', 'Azithromycin and HydroxyChloroquine', 'azithromycin', 'hydroxychloroquine', 'Azithromycin', 'Hydroxychloroquine', 'azithromycin or hydroxychloroquine', 'ergot alkaloids', 'amiodarone', 'standard treatment + placebo', 'antibiotic azithromycin and hydroxychloroquine', 'digoxin* •', 'clarithromycin', 'digoxin']","['Porphyria • Hypoglycaemia (Blood glucose', 'Severe linguistic problems', 'Severe mental illness', 'Glucose-6-phosphate dehydrogenase deficiency •', 'Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR', 'cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0033518', 'cui_str': 'PROPAC'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0587456', 'cui_str': 'Respiratory medicine department'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C4546716', 'cui_str': 'Indium-113'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0014707', 'cui_str': 'Ergot Alkaloids'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0264886', 'cui_str': 'Conduction disorder of the heart'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",226.0,0.205118,Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms).,"[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Rasmus Dahlin', 'Initials': 'RD', 'LastName': 'Bojesen', 'Affiliation': 'Department of Surgery, Næstved-Slagelse- Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Therese Sophie', 'Initials': 'TS', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Josefin Viktoria', 'Initials': 'JV', 'LastName': 'Eklöf', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Kjell Erik Julius', 'Initials': 'KEJ', 'LastName': 'Håkansson', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzki', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Tidemansen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Jon Torgny', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Gottlieb', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Howraman', 'Initials': 'H', 'LastName': 'Meteran', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Porsbjerg', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte Lindegaard', 'Initials': 'BL', 'LastName': 'Madsen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Pedersen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Lars', 'Initials': 'TL', 'LastName': 'Benfield', 'Affiliation': 'Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Jens Dilling', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip Krag', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Muzhda', 'Initials': 'M', 'LastName': 'Ghanizada', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tine Peick', 'Initials': 'TP', 'LastName': 'Sonne', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Uffe Christian Steinholtz', 'Initials': 'UCS', 'LastName': 'Bødtger', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Sidse Graff', 'Initials': 'SG', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Daniel Bech', 'Initials': 'DB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Oliver Djurhuus', 'Initials': 'OD', 'LastName': 'Tupper', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Susanne Wiemann', 'Initials': 'SW', 'LastName': 'Sørensen', 'Affiliation': 'Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Alstrup', 'Affiliation': 'Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.'}, {'ForeName': 'Christian Borbjerg', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ulla Weinrich', 'Initials': 'UW', 'LastName': 'Møller', 'Affiliation': 'Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Sverrild', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark. jens.ulrik.jensen@regionh.dk.'}]",Trials,['10.1186/s13063-020-04409-9'] 2519,32522320,"Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth.","Purposes: The purposes of this prospective trial were to: (1) compare the clinical and radiographic outcomes of three restorative methods -modified atraumatic restorative treatment (mART), the Hall technique (HT), and stainless steel crown (SSC)-in primary molars with multi-surface carious lesions; and (2) assess child behavior throughout these treatments. Methods: In this randomized controlled trial (RCT), 123 primary molars in four- to nine-year-old children were randomly divided into treatment groups (HT, mART, and SSC). Variables, including signs of failure, treatment time, child's discomfort, child's behavior, and canine overbite relationship in HT, were recorded immediately after the treatment and at six- and 12-month recalls. Results: Failures occurred most significantly for mART at all recalls (P=0.001). The treatment time was significantly higher in SSC. There was no significant difference in the child-assessment of discomfort (P=0.814). The child's behavior, as evaluated by the dentist, however, was significantly better for the SSC group. Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001). Conclusions: The high success and shorter treatment time of the Hall technique support its consideration as an alternative to the conventional technique for the treatment of carious primary teeth with multisurface lesions. The results for modified atraumatic restorative treatment were not as satisfying.",2020,Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001). ,"['123 primary molars in four- to nine-year-old children', 'primary molars with multi-surface carious lesions']","['restorative methods -modified atraumatic restorative treatment (mART), the Hall technique (HT), and stainless steel crown (SSC)-in']","['Success and Behavior', ""signs of failure, treatment time, child's discomfort, child's behavior, and canine overbite relationship in HT"", 'Failures', 'child-assessment of discomfort']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",123.0,0.0299207,Alterations to the canine overbite relationship of HT decreased significantly during recalls (P<0.001). ,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Ebrahimi', 'Affiliation': 'Dr. Ebrahimi is an associate professor of pediatric dentistry, Dental Material Research Center, Faculty of Dentistry, at the Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Alireza Sarraf', 'Initials': 'AS', 'LastName': 'Shirazi', 'Affiliation': 'Dr. Sarraf Shirazi is a full professor of pediatric dentistry, Dental Material Research Center, Faculty of Dentistry, at the Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Afshari', 'Affiliation': 'Dr. Afshari is an assistant professor of pediatric dentistry, Golestan University of Medical Sciences, Gorgan, Iran;, Email: dr.afshari@goums.ac.ir.'}]",Pediatric dentistry,[] 2520,32522396,Reply to correspondence: Intradermal sterile water injection (ISWI) versus diclofenac sodium in acute renal colic pain: A randomized controlled trial. MS 23153.,,2020,,['acute renal colic pain'],"['diclofenac sodium', 'correspondence: Intradermal sterile water injection (ISWI']",[],"[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0253166', 'cui_str': 'ISWI protein'}]",[],,0.103522,,"[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'Head of Urology Department, Zahraa Hospital, University Medical Center, Beirut, Lebanon. Electronic address: mohamadamoussa@hotmail.com.'}, {'ForeName': 'Athanasios G', 'Initials': 'AG', 'LastName': 'Papatsoris', 'Affiliation': '2nd Department of Urology, School of Medicine, Sismanoglio Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Mohamed Abou', 'Initials': 'MA', 'LastName': 'Chakra', 'Affiliation': 'Department of Urology, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.05.057'] 2521,32522414,"Immunogenicity and safety of two-visit, intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine in children living in rabies and Japanese encephalitis endemic country.","BACKGROUND Reducing the number of doses required for pre-exposure prophylaxis (PrEP) would make it more feasible and cost-effective to implement in children at the highest risk of rabies exposure in Asia. We studied immune response of 2-site intradermal (ID) injection of rabies vaccine on days 0 and 28 for rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) for children living in endemic area. RESEARCH DESIGN AND METHODS Seronegative children (n = 49) aged 12-16 months were randomized 2:1 into two groups: Group A subjects were vaccinated with 0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV), each at two sites on day (D) 0 and D28; Group B subjects were vaccinated with conventional 0.5-mL intramuscular PVRV on D0, D7 and D28. Both groups received one dose of JE-CV subcutaneously on D0 and D365. Rabies virus neutralizing antibody (RVNA) titers were measured on D0, D42 and D365 after vaccination; Japanese Encephalitis (JE) neutralizing antibody titers were determined on D0, D42, D365 and D379. RESULTS All children had RVNA ≥ 0.5 IU/mL on D42 (geometric mean titers [GMTs] of RVNA 14.35 IU/mL [Group A] and 14.83 IU/mL [Group B], p > 0.05]). On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL (p > 0.05), respectively. All children had seroprotection following booster dose of JE-CV. There were no vaccine-related SAEs observed. CONCLUSION The 2-site ID PrEP with PVRV on days 0 and 28 co-administrated with JE-CV are safe and immunogenic.",2020,"On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL","['All children had RVNA\xa0≥', 'children at the highest risk of rabies exposure in Asia', 'Seronegative children (n\xa0=\xa049) aged 12-16\xa0months', 'children living in rabies and Japanese encephalitis endemic country', 'children living in endemic area']","['pre-exposure prophylaxis (PrEP', 'rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV', 'two-visit, intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine', '2-site intradermal (ID) injection of rabies vaccine', 'JE-CV subcutaneously on D0 and D365', '0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV', '14.83\xa0IU/mL', 'IU/mL']",['Immunogenicity and safety'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034497', 'cui_str': 'Rabies virus'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0014057', 'cui_str': 'Japanese encephalitis virus disease'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014057', 'cui_str': 'Japanese encephalitis virus disease'}, {'cui': 'C0008109', 'cui_str': 'Chimera'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1320204', 'cui_str': 'Rabies prophylaxis'}, {'cui': 'C0771080', 'cui_str': 'Japanese Encephalitis Vaccines'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",49.0,0.0692663,"On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL","[{'ForeName': 'Piyada', 'Initials': 'P', 'LastName': 'Angsuwatcharakon', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand. Electronic address: Terapong.T@chula.ac.th.'}, {'ForeName': 'Natchaya', 'Initials': 'N', 'LastName': 'Ratananpinit', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Sutee', 'Initials': 'S', 'LastName': 'Yoksan', 'Affiliation': 'Center for Vaccine Development, Institute of Molecular Biosciences, Mahidol University, Bangkok 10700, Thailand.'}, {'ForeName': 'Wachiraporn', 'Initials': 'W', 'LastName': 'Saengseesom', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Roongrawee', 'Initials': 'R', 'LastName': 'Sriaksorn', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Nattasri', 'Initials': 'N', 'LastName': 'Raksahket', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand.'}, {'ForeName': 'Terapong', 'Initials': 'T', 'LastName': 'Tantawichien', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok 10330, Thailand; Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkon University, Bangkok 10330, Thailand. Electronic address: terapong_tantawichien@hotmail.com.'}]",Vaccine,['10.1016/j.vaccine.2020.05.054'] 2522,32522422,Feasibility and impact of Fit & Strong! Program in Portuguese older adults with osteoarthritis: A pilot randomized controlled trial.,"This pilot study used a small randomized trial to examine the feasibility and the impact of an 8-week multicomponent program among Portuguese older adults with osteoarthritis. Participants were identified from the electronic registers from three primary healthcare centers. Thirty-one older adults (50+ years) with osteoarthritis were randomly assigned to experimental (n= 23) and control conditions (n= 8). Acceptance, attendance and retention rates were measured. The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months. The acceptance rate was 34%, and 90.4% attended all sessions of the program. The posttest retention rate in experimental group was 69.6% and 100% in control group. Findings demonstrated benefits of the Program on physical performance, function, anxiety, and fear of movement among participants. In the future, it will be important to improve the acceptance rate, however, the high attendance rate and observed effects indicate that the program is an attractive and effective intervention for Portuguese older adults with osteoarthritis.",2020,"The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months.","['Thirty-one older adults (50+ years) with osteoarthritis', 'Portuguese older adults with osteoarthritis', 'Participants were identified from the electronic registers from three primary healthcare centers']","['multicomponent program', 'Fit & Strong']","['acceptance rate', 'posttest retention rate', 'physical performance, function, anxiety, and fear of movement', 'physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement', 'Acceptance, attendance and retention rates']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424139', 'cui_str': 'Anxiety and fear'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",31.0,0.0263707,"The effect of the program on physical performance, osteoarthritis symptomatology (pain and stiffness), functionality, physical activity, depression, anxiety and fear of movement were assessed at baseline, posttest, and 4-months.","[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Duarte', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313 Porto, Portugal. Electronic address: nataliascduarte@gmail.com.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Santos', 'Affiliation': 'University of Porto, USF Argoncilhe, Portugal. Electronic address: catarinaalmeidasantos@gmail.com.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Community Health Sciences, School of Public Health, Center for Research on Health and Aging, Institute for Health Research and Policy, University of Illinois at Chicago (MC 275), 345 Westside Research Office Bldg., 1747 West Roosevelt Road, Chicago, IL 60608. Electronic address: shughes@uic.edu.'}, {'ForeName': 'Constança', 'Initials': 'C', 'LastName': 'Paúl', 'Affiliation': 'ICBAS, CINTESIS, University of Porto, Rua Jorge Viterbo Ferreira, 228, 4050-313 Porto, Portugal. Electronic address: paul@icbas.up.pt.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.04.005'] 2523,32522495,"Re ""Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial"".",,2020,,['Vascular Surgery'],"['Re ""Gentamicin Containing Collagen Implants']",[],"[{'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0590992', 'cui_str': 'Collagen implant'}]",[],,0.162808,,"[{'ForeName': 'Barend M E', 'Initials': 'BME', 'LastName': 'Mees', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands. Electronic address: barend.mees@mumc.nl.'}, {'ForeName': 'Lina F', 'Initials': 'LF', 'LastName': 'Wübbeke', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Jan Willem H C', 'Initials': 'JWHC', 'LastName': 'Daemen', 'Affiliation': 'Department of Vascular Surgery, Maastricht UMC+, Maastricht, the Netherlands.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.04.023'] 2524,32522498,Randomized phase 2 trial and open-label extension of domagrozumab in Duchenne muscular dystrophy.,"We report results from a phase 2, randomized, double-blind, 2-period trial (48 weeks each) of domagrozumab and its open-label extension in patients with Duchenne muscular dystrophy (DMD). Of 120 ambulatory boys (aged 6 to <16 years) with DMD, 80 were treated with multiple ascending doses (5, 20, and 40 mg/kg) of domagrozumab and 40 treated with placebo. The primary endpoints were safety and mean change in 4-stair climb (4SC) time at week 49. Secondary endpoints included other functional tests, pharmacokinetics, and pharmacodynamics. Mean (SD) age was 8.4 (1.7) and 9.3 (2.3) years in domagrozumab- and placebo-treated patients, respectively. Difference in mean (95% CI) change from baseline in 4SC at week 49 for domagrozumab vs placebo was 0.27 (-7.4 to 7.9) seconds (p = 0.94). There were no significant between-group differences in any secondary clinical endpoints. Most patients had ≥1 adverse event in the first 48 weeks; most were mild and not treatment-related. Median serum concentrations of domagrozumab increased with administered dose within each dose level. Non-significant increases in muscle volume were observed in domagrozumab- vs placebo-treated patients. Domagrozumab was generally safe and well tolerated in patients with DMD. Efficacy measures did not support a significant treatment effect. Clinicaltrials.gov identifiers: NCT02310763 and NCT02907619.",2020,There were no significant between-group differences in any secondary clinical endpoints.,"['patients with Duchenne muscular dystrophy (DMD', '120 ambulatory boys (aged 6 to <16 years) with DMD, 80 were treated with multiple ascending doses (5, 20, and 40 mg/kg) of', 'patients with DMD', 'Duchenne muscular dystrophy']","['Domagrozumab', 'domagrozumab and 40 treated with placebo', 'domagrozumab and its open-label extension', 'domagrozumab', 'domagrozumab vs placebo', 'placebo']","['muscle volume', 'Median serum concentrations of domagrozumab', 'Mean (SD) age', 'functional tests, pharmacokinetics, and pharmacodynamics', 'safe and well tolerated', 'safety and mean change in 4-stair climb (4SC) time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",120.0,0.665564,There were no significant between-group differences in any secondary clinical endpoints.,"[{'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Wagner', 'Affiliation': 'Center for Genetic Muscle Disorders, Baltimore, Kennedy Krieger Institute, Departments of Neurology and Neuroscience, Johns Hopkins School of Medicine, Baltimore, MD, USA. Electronic address: wagnerk@kennedykrieger.org.'}, {'ForeName': 'Hoda Z', 'Initials': 'HZ', 'LastName': 'Abdel-Hamid', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': ""Cumming School of Medicine, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': ""Department of Pediatrics, Clinical Neurological Sciences and Epidemiology, University of Western Ontario, Children's Hospital London Health Sciences Centre, London, ON, Canada.""}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Guglieri', 'Affiliation': 'The John Walton Muscular Dystrophy Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'NIHR Great Ormond Street Hospital Biomedical Research Centre, Great Ormond Street Institute of Child Health, University College London, & Great Ormond Street Hospital Trust, London, UK.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Takeshima', 'Affiliation': 'Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""Lawson Health Research Institute: Children's Hospital, London, ON, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'Department of Neurology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Karachunski', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Butterfield', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Paediatric Neurology, Catholic University, Rome, Italy; Centro Clinico Nemo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fiorillo', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Enrico S', 'Initials': 'ES', 'LastName': 'Bertini', 'Affiliation': ""Bambino Gesu Children's Research Hospital IRCCS, Rome, Italy.""}, {'ForeName': 'Cuixia', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': ""Cincinnati Children's Hospital Medical Center; College of Medicine University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Alesia B', 'Initials': 'AB', 'LastName': 'Sadosky', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Sherlock', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Binks', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Charnas', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Marraffino', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Wong', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, USA.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.05.002'] 2525,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511'] 2526,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757'] 2527,32522756,Treatment switch in Fabry disease- a matter of dose?,"BACKGROUND Patients with Fabry disease (FD) on reduced dose of agalsidase-beta or after switch to agalsidase-alfa show a decline in chronic kidney disease epidemiology collaboration-based estimated glomerular filtration rate (eGFR) and a worsened plasma lyso-Gb3 decrease. Hence, the most effective dose is still a matter of debate. METHODS In this prospective observational study, we assessed end-organ damage and clinical symptoms in 78 patients who had received agalsidase-beta (1.0 mg/kg) for >1 year, which were assigned to continue this treatment (agalsidase-beta, regular-dose group, n=17); received a reduced dose of agalsidase-beta and subsequent switch to agalsidase-alfa (0.2 mg/kg) or a direct switch to 0.2 mg/kg agalsidase-alfa (switch group, n=22); or were re-switched to agalsidase-beta after receiving agalsidase-alfa for 12 months (re-switch group, n=39) with a follow-up of 88±25 months. RESULTS No differences for clinical events were observed for all groups. Patients within the re-switch group started with the worst eGFR values at baseline (p=0.0217). Overall, eGFR values remained stable in the regular-dose group (p=0.1052) and decreased significantly in the re-switch and switch groups (p<0.0001 and p=0.0052, respectively). However, in all groups males presented with an annual loss of eGFR by -2.9, -2.5 and -3.9 mL/min/1.73 m² (regular-dose, re-switch, switch groups, all p<0.05). In females, eGFR decreased significantly only in the re-switch group by -2.9 mL/min/1.73 m² per year (p<0.01). Lyso-Gb3 decreased in the re-switch group after a change back to agalsidase-beta (p<0.05). CONCLUSIONS Our data suggest that a re-switch to high dosage of agalsidase results in a better biochemical response, but not in a significant renal amelioration especially in classical males.",2020,"Overall, eGFR values remained stable in the regular-dose group (p=0.1052) and decreased significantly in the re-switch and switch groups (p<0.0001 and p=0.0052, respectively).","['Patients with Fabry disease (FD', '78 patients who had received agalsidase-beta (1.0 mg/kg) for >1 year']","['agalsidase-beta and subsequent switch to agalsidase-alfa (0.2 mg/kg) or a direct switch to 0.2 mg/kg agalsidase-alfa (switch group, n=22); or were re-switched to agalsidase-beta after receiving agalsidase-alfa']","['eGFR', 'Overall, eGFR values', 'annual loss of eGFR', 'glomerular filtration rate (eGFR', 'Lyso-Gb3', 'clinical events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002986', 'cui_str': ""Fabry's disease""}, {'cui': 'C1137427', 'cui_str': 'agalsidase beta'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1137427', 'cui_str': 'agalsidase beta'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0962517', 'cui_str': 'agalsidase alfa'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0082711', 'cui_str': 'globotriaosyl lysosphingolipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",78.0,0.0290459,"Overall, eGFR values remained stable in the regular-dose group (p=0.1052) and decreased significantly in the re-switch and switch groups (p<0.0001 and p=0.0052, respectively).","[{'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Lenders', 'Affiliation': 'Internal Medicine D, Department of Nephrology, Hypertension and Rheumatology and Interdisciplinary Fabry Center Münster (IFAZ), University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'Department of Internal Medicine I, Divisions of Cardiology and Nephrology, Comprehensive Heart Failure Center, Fabry Center for Interdisciplinary Therapy (FAZIT), University Hospital and University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Canaan-Kühl', 'Affiliation': 'Department of Medicine, Division of Nephrology, Charité, Universitätsmedizin Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kreul', 'Affiliation': 'Department of Internal Medicine I, Divisions of Cardiology and Nephrology, Comprehensive Heart Failure Center, Fabry Center for Interdisciplinary Therapy (FAZIT), University Hospital and University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Duning', 'Affiliation': 'Department of Neurology, and Interdisciplinary Fabry Center Münster (IFAZ), University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Lorenz', 'Affiliation': 'Department of Internal Medicine I, Divisions of Cardiology and Nephrology, Comprehensive Heart Failure Center, Fabry Center for Interdisciplinary Therapy (FAZIT), University Hospital and University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pogoda', 'Affiliation': 'Department of Cardiology I - Coronary and Peripheral Vascular Disease, Heart Failure, and Interdisciplinary Fabry Center Münster (IFAZ), University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Stefan-Martin', 'Initials': 'SM', 'LastName': 'Brand', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, and Interdisciplinary Fabry Center Münster (IFAZ), University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Internal Medicine I, Divisions of Cardiology and Nephrology, Comprehensive Heart Failure Center, Fabry Center for Interdisciplinary Therapy (FAZIT), University Hospital and University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brand', 'Affiliation': 'Internal Medicine D, Department of Nephrology, Hypertension and Rheumatology and Interdisciplinary Fabry Center Münster (IFAZ), University Hospital Münster, Münster, Germany Eva.Brand@ukmuenster.de.'}]",Journal of medical genetics,['10.1136/jmedgenet-2020-106874'] 2528,32522771,Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study.,"BACKGROUND Concurrent chemoradiotherapy is the first-line treatment for FIGO stage IIB cervical cancer. Neoadjuvant chemotherapy followed by radical surgery may provide another treatment option. PRIMARY OBJECTIVE To compare the therapeutic outcomes of neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy for stage IIB cervical cancer. STUDY HYPOTHESIS We hypothesize that the therapeutic effect of neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment will be superior to that of concurrent chemoradiotherapy in stage IIB cervical cancer. TRIAL DESIGN Patients with stage IIB cervical cancer will be randomized 1:1 to neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy (Arm B). In arm A, patients will receive three cycles of paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic ±paraaortic lymphadenectomy. Patients showing progression after neoadjuvant chemotherapy will be referred to concurrent chemoradiotherapy. Adjuvant therapy will be recommended according to the presence of pathological risks. In Arm B, all patients will receive definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy. MAJOR INCLUSION/EXCLUSION CRITERIA Patients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma. PRIMARY ENDPOINT The primary endpoint is 2-year disease-free survival. SAMPLE SIZE An estimated sample size of 240 is required to fulfill the study objectives. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS As of February 2020, 115 eligible patients from four institutions have been enrolled. Enrollment is expected to be completed by December 2022. TRIAL REGISTRATION NUMBER ClinicalTrials. gov identifier: NCT02595554.",2020,"The primary endpoint is 2-year disease-free survival. ","['Patients with stage IIB cervical cancer', '115 eligible patients from four institutions have been enrolled', 'stage IIB cervical cancer', 'Patients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma', 'FIGO stage IIB cervical cancer', 'patients with FIGO stage IIB cervical cancer']","['definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy', 'neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy', 'paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic ±paraaortic lymphadenectomy', 'Neoadjuvant chemotherapy', 'neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy', 'radical surgery versus concurrent chemoradiotherapy', 'neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment']",['2-year disease-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278583', 'cui_str': 'Cervical carcinoma stage IIB'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",115.0,0.150011,"The primary endpoint is 2-year disease-free survival. ","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Cancer Prevention, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Bingna', 'Initials': 'B', 'LastName': 'Xian', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecology, Tongji Hospital of Tongji Medical College, Wuhan, China.'}, {'ForeName': 'Yuanming', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Gynecologic Oncology, Women's hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China liujih@mail.sysu.edu.cn.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001357'] 2529,32522793,"Presentation, surgery and 1-year outcomes of childhood cataract surgery in Tanzania.","BACKGROUND Recent reports have suggested a significant change in the causes of blindness in children in low-income countries cataract becoming the leading cause. We aimed to investigate the presentations and surgical outcomes in children with cataract operated at different ages in Tanzania. METHODS We conducted a prospective study of 228 children aged ≤192 months at three tertiary centres, 177 with bilateral cataracts and prospectively followed them for 1-year postsurgery. We collected demographic, surgical, preoperative and postoperative clinical characteristics using the standard childhood cataract surgical assessment questionnaire. Families were encouraged to return for follow-up by phone with travel reimbursement where necessary. RESULTS Preoperatively, 76% bilateral children were blind in the better eye. 86% of children were followed up at 1 year and 54% bilateral children achieved visual acuity of 0.48 logMAR or better in the better eye and 5% were blind. 33% of unilateral children achieved visual acuity of 0.48 logMAR or better and 17% were blind. Preoperative blindness (adjusted OR (AOR) 14.65; 95% CI 2.21 to 97.20), preoperative nystagmus/strabismus (AOR 9.22; 95% CI 2.66 to 31.97) and aphakia (AOR, 5.32; 95% CI 1.05 to 26.97) predicted poor visual outcome in bilateral cases. 9% of 342 refracted eyes had initial postoperative cylinder of 1.5 D or more, as did a similar proportion (11%) of 315 eyes refracted 1 year after surgery. Acute fibrinous uveitis occurred in 41 (12%) eyes. CONCLUSION Three-quarters of children were blind preoperatively whereas over half had good vision 1-year postoperatively. Preoperative blindness, nystagmus/strabismus and aphakia predicted poor visual outcome, suggesting that cataract density determines density of amblyopia.",2020,"Preoperative blindness (adjusted OR (AOR) 14.65; 95% CI 2.21 to 97.20), preoperative nystagmus/strabismus (AOR 9.22; 95% CI 2.66 to 31.97) and aphakia (AOR, 5.32; 95% CI 1.05 to 26.97) predicted poor visual outcome in bilateral cases.","['228 children aged ≤192 months at three tertiary centres, 177 with bilateral cataracts and prospectively followed them for 1-year postsurgery', 'children with cataract operated at different ages in Tanzania']","['standard childhood cataract surgical assessment questionnaire', 'childhood cataract surgery in Tanzania']","['visual acuity', 'initial postoperative cylinder', 'Acute fibrinous uveitis', 'visual outcome', 'preoperative nystagmus/strabismus', 'Preoperative blindness, nystagmus/strabismus and aphakia predicted poor visual outcome', 'Preoperative blindness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302254', 'cui_str': 'Juvenile cataract'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443215', 'cui_str': 'Fibrinous'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",228.0,0.331838,"Preoperative blindness (adjusted OR (AOR) 14.65; 95% CI 2.21 to 97.20), preoperative nystagmus/strabismus (AOR 9.22; 95% CI 2.66 to 31.97) and aphakia (AOR, 5.32; 95% CI 1.05 to 26.97) predicted poor visual outcome in bilateral cases.","[{'ForeName': 'Furahini Godfrey', 'Initials': 'FG', 'LastName': 'Mndeme', 'Affiliation': 'Ophthalmology, Kilimanjaro Christian Medical University Collage, Moshi, Tanzania, United Republic of Furahini.Mndeme@lshtm.ac.uk.'}, {'ForeName': 'Blandina Theophyl', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Paediatrics, Kilimanjaro Clinical Research Institute, Kilimanjaro Christian medical Centre, Moshi, Tanzania, United Republic of.'}, {'ForeName': 'Mchikirwa', 'Initials': 'M', 'LastName': 'Msina', 'Affiliation': 'Ophthalmology, Kilimanjaro Christian Medical University Collage, Moshi, Tanzania, United Republic of.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Mwende', 'Affiliation': 'Ophthalmology, Muhimbili National Hospital, Dar-Es-Salaam, Dar-Es-Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Sonia J', 'Initials': 'SJ', 'LastName': 'Vaitha', 'Affiliation': 'Ophthalmology, Comprehensive Community Based Rehabilitation in Tanzania, Dar-Es-Salaam, Tanzania, United Republic of.'}, {'ForeName': 'Min J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Tropical Epidemiology Group, Faculty of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Gilbert', 'Affiliation': 'Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bowman', 'Affiliation': 'Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316042'] 2530,32522811,Interventions supporting long term adherence and decreasing cardiovascular events after myocardial infarction (ISLAND): pragmatic randomised controlled trial.,"OBJECTIVE To test a scalable health system intervention to improve long term adherence to secondary prevention treatments among patients who have had a recent myocardial infarction. DESIGN Three arm, pragmatic randomised controlled trial with blinded outcome assessment. SETTING Nine cardiac centres in Ontario, Canada. PARTICIPANTS 2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry. INTERVENTIONS Participants were randomised 1:1:1 to receive usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls. The phone calls were delivered first by an interactive automated system to screen for non-adherence to treatment. Trained lay health workers followed up as necessary. Interventions were coordinated centrally but delivered from each patient's hospital site. MAIN OUTCOME MEASURES Co-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors through patient report and from administrative health databases at 12 months. RESULTS 2632 patients (mean age 66, 71% male) were randomised: 878 to the full intervention (mail plus phone calls), 878 to mail only, and 876 to usual care. Of the respondents, 174 (27%) of 643 in the usual care group, 200 (32%) of 628 in the mail only group, and 196 (37%) of 531 allocated to the full intervention completed cardiac rehabilitation (adjusted odds ratio 1.55, 95% confidence interval 1.18 to 2.03). In the mail plus phone group, 11.7%, 6.0%, 14.4%, 32.9%, and 35.0% reported adherence to 0, 1, 2, 3, and 4 drug classes after one year, respectively, in comparison with 12.5%, 6.8%, 13.6%, 30.2%, and 36.8% in the mail only group, and 12.2%, 8.4%, 13.1%, 30.3%, and 36.1% in the usual care group, respectively (mail only v usual care, odds ratio 0.98, 95% confidence interval 0.81 to 1.19; full intervention v usual care, 0.99, 0.82 to 1.20). CONCLUSIONS Scalable interventions delivered by mail plus phone can increase completion of cardiac rehabilitation after myocardial infarction but not adherence to medication. More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. TRIAL REGISTRATION ClinicalTrials.gov NCT02382731, registered 9 March 2015 before any patient enrolment.",2020,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. ","['2632 patients with obstructive coronary artery disease after a myocardial infarction, identified from a centralised cardiac registry', 'Nine cardiac centres in Ontario, Canada', '2632 patients (mean age 66, 71% male) were randomised: 878 to the', 'patients who have had a recent myocardial infarction']","['full intervention (mail plus phone calls', 'usual care, five mail-outs developed through a user centred design process, or mail-outs plus phone calls']","['cardiovascular events', 'cardiac rehabilitation', 'completion of cardiac rehabilitation and adherence to recommended medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",2632.0,0.141035,"More intensive interventions should be tested to improve adherence to medication and to evaluate the association between attendance at cardiac rehabilitation and adherence to medication. ","[{'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Department of Family and Community Medicine, Women's College Hospital, 76 Grenville Street, Toronto, ON, M5S1B2, Canada noah.ivers@utoronto.ca.""}, {'ForeName': 'Jon-David', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Grace', 'Affiliation': 'Faculty of Health, York University, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cunningham', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bosiak', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Suskin', 'Affiliation': ""Cardiac Rehabilitation and Secondary Prevention Programme of St Joseph's Health Care London, ON, Canada.""}, {'ForeName': 'Harindra C', 'Initials': 'HC', 'LastName': 'Wijeysundera', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Atzema', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'R Sacha', 'Initials': 'RS', 'LastName': 'Bhatia', 'Affiliation': ""Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m1731'] 2531,32523035,Who's a good boy? Effects of dog and owner body weight on veterinarian perceptions and treatment recommendations.,"BACKGROUND Weight bias against persons with obesity impairs health care delivery and utilization and contributes to poorer health outcomes. Despite rising rates of pet obesity (including among dogs), the potential for weight bias in veterinary settings has not been examined. SUBJECTS/METHODS In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2). In both studies, participants were randomly assigned to view one of four vignettes of a dog and owners with varying weight statuses (lean vs. obesity). Dependent measures included emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations. Other clinical practices, such as terms to describe excess weight in dogs, were also assessed. RESULTS Veterinarians and students both reported feeling more blame, frustration, and disgust toward dogs with obesity and their owners than toward lean dogs and their owners (p values < 0.001). Interactions between dog and owner body weight emerged for perceived causes of obesity, such that owners with obesity were perceived as causing the dog with obesity's weight, while lean owners were perceived as causing the lean dog's weight. Participants were pessimistic about treatment compliance from owners of the dog with obesity, and weight loss treatment was recommended for the dog with obesity when presenting with a medical condition ambiguous in its relationship to weight. Veterinarians and students also reported use of stigmatizing terms to describe excess weight in dogs. CONCLUSIONS Findings from this investigation, with replication, have implications for training and practice guidelines in veterinary medicine.",2020,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).",['205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2'],[],"[""emotion/liking ratings toward the dog and owners; perceived causes of the dog's weight; and treatment recommendations and compliance expectations""]","[{'cui': 'C0242856', 'cui_str': 'Veterinarian'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",205.0,0.0204946,"In two online, 2 × 2 experimental studies, the effects of dog and owner body weight on perceptions and treatment recommendations were investigated in 205 practicing veterinarians (Study 1) and 103 veterinary students (Study 2).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. rpearl@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bach', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Leonard', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Michel', 'Affiliation': 'Department of Clinical Sciences and Advanced Medicine, University of Pennsylvania School of Veterinary Medicine, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0622-7'] 2532,32514196,"Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial.","Objective To investigate cost changes for health systems and participants, resulting from switching to short treatment regimens for multidrug-resistant (MDR) tuberculosis. Methods We compared the costs to health systems and participants of long (20 to 22 months) and short (9 to 11 months) MDR tuberculosis regimens in Ethiopia and South Africa. Cost data were collected from participants in the STREAM phase-III randomized controlled trial and we estimated health-system costs using bottom-up and top-down approaches. A cost-effectiveness analysis was performed by calculating the incremental cost per unfavourable outcome avoided. Findings Health-care costs per participant in South Africa were 8340.7 United States dollars (US$) with the long and US$ 6618.0 with the short regimen; in Ethiopia, they were US$ 6096.6 and US$ 4552.3, respectively. The largest component of the saving was medication costs in South Africa (67%; US$ 1157.0 of total US$ 1722.8) and social support costs in Ethiopia (35%, US$ 545.2 of total US$ 1544.3). In Ethiopia, trial participants on the short regimen reported lower expenditure for supplementary food (mean reduction per participant: US$ 225.5) and increased working hours (i.e. 667 additional hours over 132 weeks). The probability that the short regimen was cost-effective was greater than 95% when the value placed on avoiding an unfavourable outcome was less than US$ 19 000 in Ethiopia and less than US$ 14 500 in South Africa. Conclusion The short MDR tuberculosis treatment regimen was associated with a substantial reduction in health-system costs and a lower financial burden for participants.",2020,The short MDR tuberculosis treatment regimen was associated with a substantial reduction in health-system costs and a lower financial burden for participants.,"['multidrug-resistant tuberculosis, Ethiopia and South Africa', 'participants of long (20 to 22\xa0months) and short (9 to 11\xa0months) MDR tuberculosis regimens in Ethiopia and South Africa']",[],"['health-system costs', 'cost-effective']","[{'cui': 'C0206526', 'cui_str': 'Multidrug resistant tuberculosis'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0599748,The short MDR tuberculosis treatment regimen was associated with a substantial reduction in health-system costs and a lower financial burden for participants.,"[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Madan', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, England.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rosu', 'Affiliation': 'Centre for Applied Health Research and Delivery, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, England.'}, {'ForeName': 'Mamo Girma', 'Initials': 'MG', 'LastName': 'Tefera', 'Affiliation': 'Department of Business Management, Addis Ababa Science & Technology University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'van Rensburg', 'Affiliation': 'Health Economics and Epidemiology Research Office, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Health Economics and Epidemiology Research Office, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Langley', 'Affiliation': 'Centre for Applied Health Research and Delivery, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, England.'}, {'ForeName': 'Ewan M', 'Initials': 'EM', 'LastName': 'Tomeny', 'Affiliation': 'Centre for Applied Health Research and Delivery, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, England.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nunn', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials & Methodology, London, England.'}, {'ForeName': 'Patrick Pj', 'Initials': 'PP', 'LastName': 'Phillips', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, United States of America (USA).'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Rusen', 'Affiliation': 'Division of Research and Development, Vital Strategies, New York, USA.'}, {'ForeName': 'S Bertel', 'Initials': 'SB', 'LastName': 'Squire', 'Affiliation': 'Centre for Applied Health Research and Delivery, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Bulletin of the World Health Organization,['10.2471/BLT.19.243584'] 2533,32514277,Augmented reality-assisted training with selected Tai-Chi movements improves balance control and increases lower limb muscle strength in older adults: A prospective randomized trial.,"Background Tai-Chi benefits older adults by enhancing balance control and increasing the muscle strength of the lower limbs. However, a complete set of traditional Tai-Chi exercises is sometimes too difficult for beginners. We investigated whether practicing augmented reality-assisted training with selected Tai-Chi movements tailored to the practitioner's ability (selected Tai-Chi, or sTC) is as effective as performing a complete set of Tai-Chi sequences (complete traditional Tai-Chi, or tTC). Methods In this prospective randomized trial carried out in the Beitou District of Taipei City, Taiwan, community-dwelling adults aged ≥65 and without any debilitating diseases (n = 28) were included. Participants were randomly assigned to the sTC group (n = 14) or the tTC group (n = 14). Participants in the sTC group practiced selected Tai-Chi movements using the augmented reality Tai-Chi training system. Participants of the tTC group were asked to complete the 24-form Yang-style Tai-Chi following the instructions of Tai-Chi masters. Each training session lasted 30 min, with 3 sessions per week for 8 weeks. Pre- and post-intervention evaluations included functional balance tests, comprising the Berg Balance Scale (BBS), Timed Up and Go test (TUG), and Functional Reach Test (FRT), as well as muscle strength measurements of the lower extremities. Results Pre-intervention evaluations showed significant differences in FRT ( p  = 0.034) and left hip abductor muscle strength ( p  = 0.046) between the sTC and tTC groups. After 8 weeks of training, the BBS, TUG, and FRT scores in the sTC group showed significant improvement overall. Although all three functional balance test scores improved in the tTC group, only the improvement in BBS was statistically significant ( p  = 0.001). After 8 weeks, all muscle strength measurements increased by an average of 3.1 ± 1.0 kgw in the sTC group and 1.6 ± 0.8 kgw in the tTC group. Conclusions The augmented reality-assisted training with selected Tai-Chi movements, designed based on objective measurements of the practitioner's capability, improved balance control and muscle strength of lower limbs at least as effectively as the complete sequence of traditional Tai-Chi exercises. Trial registration This study was approved by the Institutional Review Board of National Yang-Ming University (IRB number: 1000087). Written informed consent was obtained from all participants.",2020,Pre-intervention evaluations showed significant differences in FRT ( p  = 0.034) and left hip abductor muscle strength ( p  = 0.046) between the sTC and tTC groups.,"['older adults', 'Beitou District of Taipei City, Taiwan, community-dwelling adults aged ≥65 and without any debilitating diseases (n\xa0=\xa028) were included']","['tTC', ""practicing augmented reality-assisted training with selected Tai-Chi movements tailored to the practitioner's ability (selected Tai-Chi, or sTC"", 'Augmented reality-assisted training with selected Tai-Chi movements', 'sTC group practiced selected Tai-Chi movements using the augmented reality Tai-Chi training system', 'sTC']","['functional balance tests, comprising the Berg Balance Scale (BBS), Timed Up and Go test (TUG), and Functional Reach Test (FRT), as well as muscle strength measurements of the lower extremities', 'BBS', 'FRT', 'limb muscle strength', 'BBS, TUG, and FRT scores', 'muscle strength measurements', 'left hip abductor muscle strength', 'functional balance test scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0524471', 'cui_str': 'Left hip region structure'}]",28.0,0.0386653,Pre-intervention evaluations showed significant differences in FRT ( p  = 0.034) and left hip abductor muscle strength ( p  = 0.046) between the sTC and tTC groups.,"[{'ForeName': 'Po-Jung', 'Initials': 'PJ', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, 11221, Taiwan.'}, {'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Penn', 'Affiliation': 'School of Medicine, Fu Jen Catholic University, New Taipei City, 24205, Taiwan.'}, {'ForeName': 'Shun-Hwa', 'Initials': 'SH', 'LastName': 'Wei', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, 11221, Taiwan.'}, {'ForeName': 'Long-Ren', 'Initials': 'LR', 'LastName': 'Chuang', 'Affiliation': 'Department of Chinese Martial Arts, Chinese Culture University, Taipei, 11114, Taiwan.'}, {'ForeName': 'Wen-Hsu', 'Initials': 'WH', 'LastName': 'Sung', 'Affiliation': 'Department of Physical Therapy and Assistive Technology, National Yang-Ming University, Taipei, 11221, Taiwan.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.05.003'] 2534,32514278,The effects of one session of roller massage on recovery from exercise-induced muscle damage: A randomized controlled trial.,"Background/objective Roller massage has become a popular intervention in sports settings in order to treat muscle soreness and stiffness, as well as improving post-exercise recovery, although there is limited evidence for these assumptions. Therefore, the purpose of this study was to evaluate the effects of a single session of roller massage, applied with a controlled force after an exercise-induced muscle damage protocol, on muscle recovery. Methods A randomized controlled study was performed using a repeated-measures design. Thirty-six young men completed four sets of six eccentric actions of elbow flexors at 90°/s with a 90s rest interval between sets. Participants were randomly assigned into one of three groups: 1) Roller massage (n = 12), 2) Sham (n = 12), and 3) Control (n = 12). Maximal isometric voluntary contraction (MIVC), delayed-onset muscle soreness (DOMS), range of motion (ROM), and muscle thickness were measured at baseline, and at 24, 48, and 72 h post exercise. Results There was no significant group by time interaction for MIVC (p = 0.090) and ROM (p = 0.416). Also, although there was a significant group by time interaction for muscle thickness (p = 0.028), post hoc test did not find significant difference between groups (p > 0.05). DOMS was recovered at 72 h for roller massage (p < 0.001) and control (p < 0.001) groups, while the Sham group did not recover from DOMS across 72 h (p < 0.001). There was also no significant difference between groups in DOMS at any time (p > 0.05). Conclusions A single session of roller massage applied on elbow flexors had no effect on recovery of MIVC, muscle swelling, ROM and DOMS.",2020,"A single session of roller massage applied on elbow flexors had no effect on recovery of MIVC, muscle swelling, ROM and DOMS.",['Thirty-six young men'],"['roller massage', 'Roller massage']","['DOMS', 'time interaction for muscle thickness', 'recovery of MIVC, muscle swelling, ROM and DOMS', 'Maximal isometric voluntary contraction (MIVC), delayed-onset muscle soreness (DOMS), range of motion (ROM), and muscle thickness', 'time interaction for MIVC ']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0281913', 'cui_str': 'Swelling of skeletal muscle'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",36.0,0.163452,"A single session of roller massage applied on elbow flexors had no effect on recovery of MIVC, muscle swelling, ROM and DOMS.","[{'ForeName': 'Flávia V A', 'Initials': 'FVA', 'LastName': 'Medeiros', 'Affiliation': 'College of Physical Education, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Wagner R', 'Initials': 'WR', 'LastName': 'Martins', 'Affiliation': 'Department of Physiotherapy, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Deise L F', 'Initials': 'DLF', 'LastName': 'Ribeiro', 'Affiliation': 'College of Physical Education, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Emmanuela B A', 'Initials': 'EBA', 'LastName': 'Marinho', 'Affiliation': 'College of Physical Education, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Viana', 'Affiliation': 'Faculty of Physical Education and Dance, Federal University of Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'João B', 'Initials': 'JB', 'LastName': 'Ferreira-Junior', 'Affiliation': 'Department of Education, Federal Institute of Sudeste of Minas Gerais, Rio Pomba, MG, Brazil.'}, {'ForeName': 'Jake C', 'Initials': 'JC', 'LastName': 'Carmo', 'Affiliation': 'College of Physical Education, University of Brasilia - UnB, Brasilia, Federal District, Brazil.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.05.002'] 2535,32514290,"Efficacy of acupuncture in the prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: a multi-center, single-blind, randomized, sham-controlled clinical research.","Background Chemotherapy-induced nausea and vomiting (CINV) is a common and distressing side effect. We conducted this clinical trial to compare the effectiveness of true acupuncture vs. sham acupuncture in controlling chemotherapy-induced nausea and vomiting (CINV) among patients with advanced cancer. Methods A total of 134 participants were randomly allocated into true acupuncture (TA) (n = 68) and sham acupuncture (SA) (n = 66) groups. Participants in both groups received acupuncture session twice on the first day of chemotherapy, and once consecutively on the following 4 days. The primary outcome was using the Common Terminology Criteria for Adverse Events (CTCAE) to assess CINV. The secondary outcome measures were the Eastern Cooperative Oncology Group score (ECOG), Simplified Nutritional Appetite Questionnaire (SNAQ), and Hospital Anxiety and Depression scale (HADS). Results Compared to the SA group, the TA group didn't show significant improvement in complete response rates of chemotherapy-induced nausea and vomiting (all P > 0.05). However, the TA group could modestly reduce the severity of nausea (from day-3 to day-21, P < 0.05) or vomiting (from day-4 to day-21, P < 0.05), which is notably superior to the control group. Besides, TA promoted the nutritional status of patients with a significantly higher score comparing to the SA group on day 14 (21.82 vs.20.12, P = 0.003) and day 21 (22.39 vs. 20.43, P = 0.001). No apparent differences were found in anxiety and depression assessment between these groups. Participants in both groups were well tolerant of acupuncture therapy. There was no adverse event occurs in our study. Conclusion Acupuncture as an adjunctive approach could alleviate the severity of chemotherapy-induced nausea and vomiting compared to the sham control, even though the effect of acupuncture in preventing CINV occurring is relatively modest.",2020,"Compared to the SA group, the TA group didn't show significant improvement in complete response rates of chemotherapy-induced nausea and vomiting (all P > 0.05).","['134 participants', 'patients with advanced cancer']","['acupuncture', 'true acupuncture (TA) (n\u2009=\u200968) and sham acupuncture (SA', 'acupuncture session', 'acupuncture vs. sham acupuncture', 'Acupuncture', 'acupuncture therapy']","['severity of nausea', 'Eastern Cooperative Oncology Group score (ECOG), Simplified Nutritional Appetite Questionnaire (SNAQ), and Hospital Anxiety and Depression scale (HADS', 'nausea and vomiting (CINV', 'anxiety and depression assessment', 'the Common Terminology Criteria for Adverse Events (CTCAE) to assess CINV', 'complete response rates of chemotherapy-induced nausea and vomiting', 'nausea and vomiting', 'vomiting']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",134.0,0.059844,"Compared to the SA group, the TA group didn't show significant improvement in complete response rates of chemotherapy-induced nausea and vomiting (all P > 0.05).","[{'ForeName': 'Qi-Wei', 'Initials': 'QW', 'LastName': 'Li', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Yu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Guo-Wang', 'Initials': 'GW', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Chen-Xi', 'Initials': 'CX', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xue', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Wei-Ru', 'Initials': 'WR', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Cheng', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing, 100010 China.'}]",Chinese medicine,['10.1186/s13020-020-00333-x'] 2536,32514451,"Colonoscopy using back brace support belt: A randomized, prospective trial.","Background and Aim Looping is a major problem in colonoscopy, and it prolongs procedure time. We evaluated the efficacy and safety of an external abdominal compression device (back brace support belt; Maxbelt) with respect to cecal insertion time and other outcomes. Methods We performed a prospective study on outpatients undergoing elective colonoscopy in Toyoshima Endoscopy Clinic. Subjects were randomly assigned to groups and were subjected to either Maxbelt ( n = 39) or no device (control, n = 38) during colonoscopy. The colonoscopist was blinded to the study. The primary outcome that was observed was insertion time. Results The intubation time of the Maxbelt group was shorter than that of the no device group, but the difference was not significant (3.29 vs 4.49 min, P = 0.069). After stratifying by age, the use of Maxbelt significantly decreased cecal intubation time in elderly participants (age ≥ 45) compared to no device group (3.27 vs 5.00 min, P = 0.032). The use of the Maxbelt significantly decreased insertion difficulty encountered by the colonoscopist ( P = 0.01). There was no difference in adenoma detection rate, manual pressure, position change, and adverse event. Conclusions The use of a back brace support belt could be a viable approach for colonoscopy in elderly patients. (University Hospital Medical Information Network: UMIN000029361).",2020,The use of the Maxbelt significantly decreased insertion difficulty encountered by the colonoscopist ( P = 0.01).,"['elderly patients', 'outpatients undergoing elective colonoscopy in Toyoshima Endoscopy Clinic']","['Maxbelt ( n = 39) or no device (control, n = 38) during colonoscopy', 'external abdominal compression device (back brace support belt; Maxbelt', 'Colonoscopy']","['efficacy and safety', 'adenoma detection rate, manual pressure, position change, and adverse event', 'intubation time', 'insertion time', 'cecal intubation time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0179188', 'cui_str': 'Back braces'}, {'cui': 'C0336622', 'cui_str': 'Support belt'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444793', 'cui_str': 'Position change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}]",,0.0634259,The use of the Maxbelt significantly decreased insertion difficulty encountered by the colonoscopist ( P = 0.01).,"[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Toyoshima', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Sakitani', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Tadahiro', 'Initials': 'T', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Fukagawa', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Department of Gastroenterology Graduate School of Medicine, The University of Tokyo, Toyoshima Endoscopy Clinic Tokyo Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ishihara', 'Affiliation': 'Department of Surgical Oncology, Graduate School of Medicine The University of Tokyo Tokyo Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology and Hepatology Tokai University School of Medicine Tokyo Japan.'}]",JGH open : an open access journal of gastroenterology and hepatology,['10.1002/jgh3.12276'] 2537,32514590,Time to intra-arrest therapeutic hypothermia in out-of-hospital cardiac arrest patients and its association with neurologic outcome: a propensity matched sub-analysis of the PRINCESS trial.,"PURPOSE To study the association between early initiation of intra-arrest therapeutic hypothermia and neurologic outcome in out-of-hospital cardiac arrest. METHODS A prespecified sub-analysis of the PRINCESS trial (NCT01400373) that randomized 677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival. Early cooling (intervention) was defined as intra-arrest cooling initiated < 20 min from collapse (i.e., ≤ median time to cooling in PRINCESS). Propensity score matching established comparable control patients. Primary outcome was favorable neurologic outcome, Cerebral Performance Category (CPC) 1-2 at 90 days. Complete recovery (CPC 1) was among secondary outcomes. RESULTS In total, 300 patients were analyzed and the proportion with CPC 1-2 at 90 days was 35/150 (23.3%) in the intervention group versus 24/150 (16%) in the control group, odds ratio (OR) 1.92, 95% confidence interval (CI) 0.95-3.85, p = .07. In patients with shockable rhythm, CPC 1-2 was 29/57 (50.9%) versus 17/57 (29.8%), OR 3.25, 95%, CI 1.06-9.97, p = .04. The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02. In patients with shockable rhythms, the proportion with CPC 1 was 27/57 (47.4%) versus 12/57 (21.1%), OR 5.33, 95% CI 1.55-18.3, p = .008. CONCLUSIONS In the whole study population, intra-arrest cooling initiated < 20 min from collapse compared to cooling initiated at hospital was not associated with improved favorable neurologic outcome. In the subgroup with shockable rhythms, early cooling was associated with improved favorable outcome and complete recovery.",2020,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.",[],"['677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival', 'Time to intra-arrest therapeutic hypothermia']","['favorable outcome and complete recovery', 'favorable neurologic outcome, Cerebral Performance Category (CPC', 'favorable neurologic outcome']",[],"[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",677.0,0.16917,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.","[{'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Awad', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jonsson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Anatolij', 'Initials': 'A', 'LastName': 'Truhlar', 'Affiliation': 'Emergency Medical Services of the Hradec Kralove Region, Hradec Králové, Czech Republic.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Ringh', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'The Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lance B', 'Initials': 'LB', 'LastName': 'Becker', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, 11030, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Svensson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden. per.nordberg@sll.se.'}]",Intensive care medicine,['10.1007/s00134-020-06024-3'] 2538,32514607,"Effects of 3-month high-intensity interval training vs. moderate endurance training and 4-month follow-up on fat metabolism, cardiorespiratory function and mitochondrial respiration in obese adults.","PURPOSE The purpose of this study was to investigate, in obese adults, changes in body composition, physical capacities, fat oxidation and ex vivo mitochondrial respiration induced by a 3-month either moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT); afterwards, the patients were followed for four months. METHODS Thirty-two patients (mean age 39 years; mean body mass index [BMI] 36 kg∙m -2 ) participated in this study attending ~ 34 sessions of training. At baseline (PRE), at the end of the program (POST) and after follow-up, body composition, peak O 2 uptake (V'O 2 peak) and fat oxidation rate were measured. Vastus lateralis biopsies for the evaluation of mitochondrial respiration were performed only at PRE and POST. RESULTS At POST, body mass (BM) and fat mass (FM) decreased (- 6 and - 14%, respectively, P < 0.05) in MICT and HIIT; V'O 2 peak increased in both groups (+ 6 and + 16%, respectively, P < 0.05). Maximal fat oxidation rate increased only after HIIT (P < 0.001). Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference. After follow-up, BM and FM were still lower (- 4 and - 20%, respectively, P < 0.050) compared with baseline in both groups. Only after HIIT, V'O 2 peak (+ 8%) and maximal fat oxidation rate were still higher (P < 0.05). CONCLUSIONS HIIT was more effective in improving and maintaining V'O 2 peak and fat oxidation. These results may be relevant for an appropriate prescription of training programs designed to optimize aerobic fitness in obese subjects.",2020,"Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference.","['obese subjects', 'Thirty-two patients (mean age 39\xa0years', 'obese adults']","['moderate-intensity continuous training (MICT) or high-intensity interval training (HIIT', '3-month high-intensity interval training vs. moderate endurance training']","['body mass (BM) and fat mass (FM', 'fat metabolism, cardiorespiratory function and mitochondrial respiration', 'body composition, physical capacities, fat oxidation and ex vivo mitochondrial respiration', 'Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase', 'maximal fat oxidation rate', ""body composition, peak O 2 uptake (V'O 2 peak) and fat oxidation rate"", 'Maximal fat oxidation rate', 'BM and FM', ""effective in improving and maintaining V'O 2 peak and fat oxidation""]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0008855', 'cui_str': 'Citrate(si)-synthase'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",-2.0,0.024213,"Maximal ADP-stimulated mitochondrial respiration normalized by citrate synthase increased (P < 0.05) by 67% and 36% in MICT and HIIT, respectively, without significant difference.","[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Vaccari', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy. vaccari.filippo@spes.uniud.it.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Passaro', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': ""D'Amuri"", 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Juana Maria', 'Initials': 'JM', 'LastName': 'Sanz', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Di Vece', 'Affiliation': 'Department of Medicine, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Capatti', 'Affiliation': 'Department of Medicine, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Magnesa', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Comelli', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Mavelli', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Grassi', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fiori', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bravo', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Avancini', 'Affiliation': 'Biomedical, Clinical and Experimental Sciences, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Parpinel', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Lazzer', 'Affiliation': 'Department of Medicine, University of Udine, P.le Kolbe 4, 33100, Udine, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04409-2'] 2539,32514638,Invited Discussion on: Effect of Photobiomodulation on Ecchymosis After Rhinoplasty-A Randomized Single-Blind Controlled Trial.,,2020,,[],['Photobiomodulation'],['Ecchymosis'],[],[],"[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",,0.0949956,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Iran University of Medical Sciences, St. Fatima Hospital and Burn Research Center, Suite 12, Number 33, Asef St., Zaferanieh, Tehran, 1988893337, Iran. fhafezi32@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01795-y'] 2540,32514677,Impact of core stability exercises on bone mineralization and functional capacity in children with polyarticular juvenile idiopathic arthritis: a randomized clinical trial.,"BACKGROUND Juvenile idiopathic arthritis (JIA) is the most prevalent rheumatic disease in children. The core stability exercises ensure proper muscular strength and balance around the lumbo-pelvic-hip complex. OBJECTIVE This study evaluated whether the use of core stability exercises would increase the effectiveness of conventional physical therapy (PT) in enhancing bone mineralization and improving functional capacity in children with polyarticular JIA. METHODS Thirty-three children with polyarticular JIA (age; 10-14 years) assigned randomly into two groups: the control group (n = 16) received the conventional PT, and the study group (n = 17) received the core stability exercises in addition to the same conventional PT program. Both core stability and conventional PT exercises continued for 3 months. The measures of bone mineralization and functional ability were investigated by dual-energy X-ray absorptiometry (DXA) device and 6-min walk test (6MWT), respectively, at baseline and immediately post-treatment. RESULTS Analysis of covariance (ANCOVA) revealed significant differences between groups in favor of the study group regarding measures of bone mineralization of lumbar spine and femoral neck regions as P < 0.05, except for volumetric bone mineral density of lumbar spine the P > 0.05. There was a significant difference between the two groups concerning functional capacity measured in 6MWT (P < 0.05), where children in the study group walked 531.71 ± 90.59 m compared with the control group 509.31 ± 73.10 m. CONCLUSION Core stability exercises are an effective adjunctive therapy to enhance bone health status and improve functional capacity in children with polyarticular JIA.Key Points• In addition to conventional physical therapy, core stability exercises had a definite effect on improving bone health status and quality of life in children with polyarticular juvenile idiopathic arthritis.• Improved bone mineralization and functional capacity due to core stability exercises contain two parts: strengthening training and controlling equilibrium.",2020,"There was a significant difference between the two groups concerning functional capacity measured in 6MWT (P < 0.05), where children in the study group walked 531.71 ± 90.59 m compared with the control group 509.31 ± 73.10 m. CONCLUSION ","['children with polyarticular JIA', 'children with polyarticular juvenile idiopathic arthritis', 'children with polyarticular JIA.Key Points•', 'children with polyarticular juvenile idiopathic', 'Thirty-three children with polyarticular JIA (age; 10-14\xa0years']","['core stability exercises in addition to the same conventional PT program', 'conventional PT', 'conventional physical therapy (PT', 'conventional physical therapy, core stability exercises', 'Core stability exercises', 'core stability exercises', 'conventional PT exercises']","['functional capacity measured in 6MWT', 'bone health status and quality of life', 'dual-energy X-ray absorptiometry (DXA) device and 6-min walk test (6MWT', 'bone mineralization and functional capacity', 'volumetric bone mineral density of lumbar spine', 'functional capacity', 'bone mineralization and functional ability', 'bone mineralization of lumbar spine and femoral neck regions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4521004', 'cui_str': 'Polyarticular juvenile idiopathic arthritis'}, {'cui': 'C0240789', 'cui_str': 'Polyarticular'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",33.0,0.0407548,"There was a significant difference between the two groups concerning functional capacity measured in 6MWT (P < 0.05), where children in the study group walked 531.71 ± 90.59 m compared with the control group 509.31 ± 73.10 m. CONCLUSION ","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Riyadh, Saudi Arabia. waleeds306@yahoo.com.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Clinical rheumatology,['10.1007/s10067-020-05219-9'] 2541,32514802,A Multicenter Phase 2 Trial to Evaluate the Efficacy of mFOLFOX6 + Cetuximab as Induction Chemotherapy to Achieve R0 Surgical Resection for Advanced Colorectal Liver Metastases (NEXTO Trial).,"BACKGROUND The effect of cetuximab plus mFOLFOX on downsizing of the tumors for curative resection has yet to be assessed for patients with advanced colorectal liver metastases (CRLMs). This study aimed to assess the oncologic benefit of cetuximab plus mFOLFOX for wild-type KRAS patients with advanced CRLMs. METHODS In this multicenter phase 2 trial, patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS were treated with mFOLFOX plus cetuximab. The patients were assessed for resectability after 4 treatments, and then every 2 months up to 12 treatments. Patients with resectable disease were offered surgery after a waiting period of 1 month. The primary end point of the study was the R0 resection rate. The secondary end points were safety, progression-free survival (PFS), and overall survival (OS). The study is registered with the University Hospital Medical Information Network-Clinical Trials Registry Clinical Trials Registry (no. C000007923). RESULTS Between 2012 and 2015, 50 patients from 13 centers were enrolled in this trial. Two patients were excluded because they had not received induction therapy. The 48 patients had a complete response rate of 0% and a partial response rate of 64.6%. For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred. During a median follow-up period of 31 months, the median OS for all the patients was calculated to be 41 months (95% confidence interval, 28-not reached). The 3-year OS rate was 59%. CONCLUSION For patients with advanced CRLMs harboring wild-type KRAS, cetuximab administered in combination with mFOLFOX yields high response rates, leading to significantly high R0 resection rates and favorable prognoses.",2020,"For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred.","['Two patients were excluded because they had not received induction therapy', 'patients with advanced colorectal liver metastases (CRLMs', 'Between 2012 and 2015', '50 patients from 13 centers were enrolled in this trial', 'wild-type KRAS patients with advanced CRLMs', 'patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS', 'Patients with resectable disease']","['mFOLFOX plus cetuximab', 'cetuximab plus mFOLFOX', 'mFOLFOX6\u2009+\u2009Cetuximab']","['median OS', 'partial response rate', 'R0 resection rate', 'complete response rate', '3-year OS rate', 'safety, progression-free survival (PFS), and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",2.0,0.0996801,"For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred.","[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Mise', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan. kihase-tky@umin.ac.jp.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Saiura', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Oba', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yamamoto', 'Affiliation': 'National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Asahi General Hospital, Asahi, Japan.'}, {'ForeName': 'Tadatoshi', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Nihon University School of Medicine, Itabashi City, Japan.'}, {'ForeName': 'Yojiro', 'Initials': 'Y', 'LastName': 'Hashiguchi', 'Affiliation': 'Teikyo University School of Medicine, Itabashi City, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shibasaki', 'Affiliation': 'JCHO Tokyo Yamate Medical Center, Shinjuku City, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'Saitama Cancer Center Hospital, Ina, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yamagata', 'Affiliation': 'JCHO Tokyo Shinjuku Medical Center, Shinjuku City, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aoyanagi', 'Affiliation': 'Kohnodai Hospital, National Center for Global-Health and Medicine, Shinjuku City, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Kaneko', 'Affiliation': 'Toho University Faculty of Medicine, Ota City, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Koyama', 'Affiliation': 'JCHO Tokyo Takanawa Hospital, Minato City, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nozawa', 'Affiliation': 'Colon and Rectal Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}]",Annals of surgical oncology,['10.1245/s10434-020-08627-y'] 2542,32510976,Single-Session Bronchial Thermoplasty Guided by 129 Xe Magnetic Resonance Imaging: A Pilot Randomized Clinical Trial.,"RATIONALE Adverse events have limited the use of bronchial thermoplasty (BT) in severe asthma. OBJECTIVES We sought to evaluate the effectiveness and safety of using 129Xe MRI to prioritize the most involved airways for guided BT. METHODS Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects. Subjects were randomized to treatment of the six most involved airways in the first session (guided group) or a standard three-session BT (unguided). The primary outcome was the change in Asthma Quality of Life Questionnaire (AQLQ) score from baseline after the first BT for the guided group compared to after three treatments for the unguided group. MEASUREMENTS AND MAIN RESULTS There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201). After one BT, the guided group had a greater reduction in the percent of poorly/non-ventilated lung from baseline when compared to unguided (-17.2%, P=0.009). At one year, both AQLQ and asthma control tests (ACT) improved from baseline (ΔAQLQ=1.50±1.63 P=<0.001, ΔACT=5.61±5.24 P<0.001) and there was no significant difference between groups. Thirty-three percent experienced asthma exacerbations after one guided BT compared to 73% after three unguided BT (P=0.028). CONCLUSION Results of this pilot study suggest that similar short-term improvements with improved safety can be achieved with one BT treatment guided by 129Xe MRI when compared to standard BT.",2020,"MEASUREMENTS AND MAIN RESULTS There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).",['Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects'],"['standard three-session BT (unguided', '129 Xe Magnetic Resonance Imaging', 'Single-Session Bronchial Thermoplasty Guided by']","['quality of life', 'percent of poorly/non-ventilated lung', 'change in Asthma Quality of Life Questionnaire (AQLQ) score', 'asthma exacerbations', 'AQLQ and asthma control tests (ACT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}]",30.0,0.171046,"MEASUREMENTS AND MAIN RESULTS There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).","[{'ForeName': 'Chase S', 'Initials': 'CS', 'LastName': 'Hall', 'Affiliation': 'University of Kansas Medical Center, 21638, Pulmonary/Critical Care Medicine, Kansas City, Kansas, United States.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Quirk', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Radiology, Saint Louis, Missouri, United States.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Biostatistics, Saint Louis, Missouri, United States.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Biostatistics, Saint Louis, Missouri, United States.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kozlowski', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Biostatistics, Saint Louis, Missouri, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Thomen', 'Affiliation': 'University of Missouri Columbia, 14716, Columbia, Missouri, United States.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Woods', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, 2518, Pediatrics & Radiology, Cincinnati, Ohio, United States.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'University of Virginia, 2358, Radiology and Medical Imaging, Charlottesville, Virginia, United States.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mugler', 'Affiliation': 'University of Virginia, 2358, Radiology and Medical Imaging, Charlottesville, Virginia, United States.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Gallagher', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Radiology, Saint Louis, Missouri, United States.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Pulmonary and Critical Care Medicine, Saint Louis, Missouri, United States.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Washington University in Saint Louis School of Medicine, 12275, Biostatistics, Saint Louis, Missouri, United States.'}, {'ForeName': 'Iulian C', 'Initials': 'IC', 'LastName': 'Ruset', 'Affiliation': 'XeMed, LLC, Durham, New Hampshire, United States.'}, {'ForeName': 'F William', 'Initials': 'FW', 'LastName': 'Hersman', 'Affiliation': 'XeMed, LLC, Durham, New Hampshire, United States.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, 12251, Pulmonary/Critical Care Medicine, Kansas City, Kansas, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-1021OC'] 2543,32510985,Large Drill Holes Are Still Present in the Long Term After Arthroscopic Bankart Repair With Absorbable Tacks: An 18-Year Randomized Prospective Study.,"BACKGROUND Studies have demonstrated the development of an osseous reaction at the drill sites of anchors after arthroscopic shoulder surgery. PURPOSE To investigate the drill-hole size at 18 years after arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks and to compare the functional outcomes and development of osteoarthritis. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS 40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair, were randomized into the PGA group (n = 20) or the PLLA group (n = 20). Plain radiographs of both shoulders, as well as computed tomography (CT) images of the operated shoulder, were used to evaluate the drill-hole size, volume, and degenerative changes. Functional outcomes were assessed by use of the Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index. RESULTS Of the 40 patients, 32 patients returned for the follow-up (15 PGA and 17 PLLA). No significant differences were found in the population characteristics between the study groups. The mean follow-up time was 18 years for both groups. No significant differences were seen in range of motion, strength in abduction, or Constant, Rowe, and WOSI scores between the groups. Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07). The drill-hole appearance on plain radiographs (invisible/hardly visible/visible/cystic) was 11/2/2/0 and 6/5/5/1 for the PGA and PLLA groups, respectively ( P = .036). The mean ± SD drill-hole volume as estimated on CT images was 89 ± 94 and 184 ± 158 mm 3 in the PGA and PLLA groups, respectively ( P = .051). Degenerative changes (normal/minor/moderate/severe) on plain radiographs were 7/4/4/0 and 3/8/5/1 for the PGA and PLLA groups, respectively ( P = .21), and on CT images were 5/7/3/0 and 2/6/6/3 for the PGA and PLLA groups, respectively ( P = .030). CONCLUSION This long-term follow-up study demonstrated that the PLLA group had significantly more visible drill holes than the PGA group on plain radiographs. However, this difference was not evident on CT imaging, with both groups having several visible cystic drill holes and a substantial drill-hole volume defect. No significant differences were found between the study groups in terms of clinical outcomes.",2020,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07).,"['40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair', '40 patients']","['arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks', 'Arthroscopic Bankart Repair With Absorbable Tacks', 'PGA', 'PLLA']","['Degenerative changes', 'plain radiographs', 'Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index', 'CT images', 'range of motion, strength in abduction, or Constant, Rowe, and WOSI scores', 'Recurrence rate', 'visible drill holes', 'drill-hole appearance on plain radiographs', 'mean ± SD drill-hole volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1101255', 'cui_str': 'polylevolactic acid'}, {'cui': 'C3874006', 'cui_str': 'Tack'}]","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.0322059,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07).,"[{'ForeName': 'Christina Chrysanthou', 'Initials': 'CC', 'LastName': 'Constantinou', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}, {'ForeName': 'Ninni', 'Initials': 'N', 'LastName': 'Sernert', 'Affiliation': 'Department of Research and Development, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rostgård-Christensen', 'Affiliation': 'Department of Radiology, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Kartus', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}]",The American journal of sports medicine,['10.1177/0363546520922191'] 2544,32510984,Genotype-Guided Dosing of Warfarin in Chinese Adults: A Multicenter Randomized Clinical Trial.,"Background - Warfarin is an effective treatment for thromboembolic disease but has a narrow therapeutic index; optimal anticoagulation dosage can differ tremendously among individuals. We aimed to evaluate whether genotype-guided warfarin dosing is superior to routine clinical dosing for the outcomes of interest in Chinese patients. Methods - We conducted a multicenter, randomized, single-blind, parallel-controlled trial from September 2014 to April 2017 in 15 hospitals in China. Eligible patients were 18 years or older, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder. Nine follow-up visits were performed during the 12-week study period. The primary outcome measure was the percentage of time in the therapeutic range (%TTR) of the international normalized ratio (INR) during the first 12 weeks after starting warfarin therapy. Results - A total of 660 participants were enrolled and randomly assigned to a genotype-guided dosing group or a control group under standard dosing. The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01). The genotype-guided dosing group also achieved the target INR sooner than the control group. In subgroup analyses, warfarin normal sensitivity group had an even higher %TTR during the first 12 weeks compared to the control group (60.8% vs. 48.9%; 95% CI: 1.1-24.4). The incidence of adverse events was low in both groups. Conclusions - The outcomes of genotype-guided warfarin dosing were superior to those of clinical standard dosing. These findings raise the prospect of precision warfarin treatment in China.",2020,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","['Chinese patients', '660 participants', 'Eligible patients were 18 years or older, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder', 'September 2014 to April 2017 in 15 hospitals in China', 'Chinese Adults']","['genotype-guided dosing group or a control group under standard dosing', 'Genotype-Guided Dosing of Warfarin', 'genotype-guided warfarin', ' - Warfarin']","['percentage of time in the therapeutic range (%TTR) of the international normalized ratio (INR', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",660.0,0.107551,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","[{'ForeName': 'Chengxian', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Center of Clinical Pharmacology, Department of Pharmacy, the Third Xiangya Hospital, Central South University & Research Center of Drug Clinical Evaluation of Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University & Research Center of Drug Clinical Evaluation of Central South University, Changsha, China.'}, {'ForeName': 'Honghao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jingle', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chee M', 'Initials': 'CM', 'LastName': 'Ng', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital & Institute of Clinical Pharmacology, Hunan Key Laboratory of Pharmacogenetics, Central South University, Changsha, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital & Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center on the Early Life Origins of Disease, Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health & Division of General Pediatrics & Adolescent Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Miao', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, the Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zewei', 'Initials': 'Z', 'LastName': 'Ouyang', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, Shaoyang, China.'}, {'ForeName': 'Xiangjiang', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, Shaoyang, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, Shaoyang, China.""}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, Shaoyang, China.""}, {'ForeName': 'Guozuo', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Vascular Surgery, the Second Affiliated Hospital of University of South China, Hengyang, China.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of University of South China, Hengyang, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, Xiangtan Central Hospital, Xiangtan, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, Hunan Provincial People's Hospital, Changsha, China.""}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, the Third Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fanghua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Xiangtan City, Xiangtan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of University of South China, Hengyang, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chenzhou First People's Hospital, Chenzhou, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiology, the Fourth Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Loudi Central Hospital, Loudi, China.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Yiyang Central Hospital, Yiyang, China.'}, {'ForeName': 'Qiulian', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'School of Mathematics and Statistics, Central South University, Changsha, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Mathematics and Statistics, Central South University, Changsha, China.'}, {'ForeName': 'Haigang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Changsha Medical University, Changsha, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shanjie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Department of Pharmacy, the Third Xiangya Hospital, Central South University & Research Center of Drug Clinical Evaluation of Central South University, Changsha, China.'}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002602'] 2545,32523295,A prospective study of two methods of analgesia in shoulder arthroscopic procedures as day case surgery.,"Background & purpose The recent advances in anaesthesia and analgesia have significantly improved the early recovery and effective post-operative pain control in day care surgery e.g. shoulder arthroscopic procedures. Adequate analgesia improves the early rehabilitation for a better outcome. We prospectively evaluated the post-operative pain relief following the two methods of analgesia i.e. regional Inter-scalene block (ISB) vs Intra-articular (IA) injection using 0.5% Chirocaine in various therapeutic arthroscopic shoulder procedures. Methods A prospective comparative study was performed on a group of 105 patients (ASA grade I or II) who underwent the following procedures at two different hospitals: diagnostic arthroscopy, subacromial decompression (SAD) alone, SAD in combination with mini open cuff repairs or distal clavicle excision, anterior stabilization (Bankart's repair) and inferior capsular shift. A successful Inter-scalene block (0.5% Chirocaine-30mls) preceded the general anaesthesia (Group 1-52 patients). Local intra-articular infiltration (0.5% Chirocaine - 20 mls) was given postoperatively (Group 2-53 patients). Post operatively visual analogue scores (VAS) from 0 (no pain) to 10 (severe pain) were assessed in post-anaesthesia care unit (PACU), at 4hrs, at 24hrs and at 48 h. The amount of morphine consumption for the first 2 days after surgery was recorded. Results Patient characteristics were similar in both groups at both the hospitals. The median postoperative pain score of VAS <3 was observed in both groups. Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals. The mean length of adequate sensory block in group 1 was significantly higher than in group 2 [20.5 h: 4.2 h] (p < 0.001). The mean analgesic (morphine) consumption was lower in Group 1 as compared to Group 2 [4.6 mg/24 h: 18.8mg/24 h](p < 0.0001). Bone shaving procedures e.g. SAD, SAD + Rotator Cuff repair, SAD + Lateral clavicular excision required significantly higher analgesia in both groups compared to the soft tissue procedures. Conclusion Single dose ISB provided longer and effective postoperative analgesia. The bone shaving procedures required more analgesia in IA Group as compared to ISB Group.",2020,Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals.,"['105 patients (ASA grade I or II) who underwent the following procedures at two different hospitals', 'shoulder arthroscopic procedures as day case surgery']","['Bone shaving procedures', ""diagnostic arthroscopy, subacromial decompression (SAD) alone, SAD in combination with mini open cuff repairs or distal clavicle excision, anterior stabilization (Bankart's repair) and inferior capsular shift"", 'analgesia i.e. regional Inter-scalene block (ISB) vs Intra-articular (IA) injection using 0.5% Chirocaine', 'analgesia']","['e.g. SAD, SAD\xa0+\xa0Rotator Cuff repair, SAD\xa0+\xa0Lateral clavicular excision', 'mean analgesic (morphine) consumption', 'Local intra-articular infiltration', 'effective postoperative analgesia', 'analgesia', 'median postoperative pain score of VAS <3', 'mean length of adequate sensory block', 'Post operatively visual analogue scores (VAS) from 0 (no pain) to 10 (severe pain', 'VAS scores']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0567344', 'cui_str': 'Shave excision'}, {'cui': 'C0407864', 'cui_str': 'Diagnostic arthroscopy of joint'}, {'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0473639', 'cui_str': 'Stabilization of joint by repair of capsule'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0875986', 'cui_str': 'Chirocaine'}]","[{'cui': 'C0408159', 'cui_str': 'Anterior decompression of shoulder joint'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",105.0,0.0307327,Significant difference (p < 0.0001) was observed in the VAS scores between the two groups at all the time intervals.,"[{'ForeName': 'Ujjwal K', 'Initials': 'UK', 'LastName': 'Debnath', 'Affiliation': 'Dept of Orthopaedics, MMIMSR, Mullana, Ambala, 133107, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': ""Dept of Orthopaedics, King's Mill Hospital, Mansfield Road, Sutton-In-Ashfield, Nottinghamshire, NG17 4JL, UK.""}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Saini', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Neev', 'Initials': 'N', 'LastName': 'Trehan', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Trehan', 'Affiliation': 'Dept of Orthopaedics, Lincoln County Hospital, Greetwell Road, Lincoln, Lincolnshire, LN2 5QY, UK.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.06.008'] 2546,32523337,Effectiveness and Economic Evaluation of Hospital-Outreach Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease.,"Objective Hospital-outreach pulmonary rehabilitation (PR) can improve health status and reduce health-care utilization by patients with chronic obstructive pulmonary disease (COPD). However, its long-term effects and costs versus benefits are still not clear. This study was conducted to develop, deliver, and evaluate the effects and monetary savings of a hospital-outreach PR program for patients with COPD. Methods A randomized controlled trial was conducted. Patients with COPD (n=208) were randomly assigned to the hospital-outreach PR program (treatment) or treatment as usual (control). The treatment group received a 3-month intensive intervention, including supervised physical exercise, smoking cessation, self-management education, and psychosocial support, followed by long-term access to a nurse through telephone follow-up and home visits up to 24 months. The control group received routine care, including discharge education and a self-management education brochure. Main outcomes were collected at 3, 6, 12, and 24 -months postrandomization. Primary outcomes included health-care utilization (ie, readmission rates, times, and days, and emergency department visits) and medical costs. Secondary outcomes included lung function (ie, FEV 1 , FEV 1 % predicted, FVC), dyspnea (mMCR), exercise capacity (6MWD), impact on quality of life (CAT), and self-management (CSMS). Results At the end of 24 months, 85 (81.7%) in the treatment group and 89 (85.6%) in the control group had completed the whole program. Compared with the control group, patients in the treatment group had lower readmission rates, times, and days at 6 and 12 months and during 12-24 months. Regarding costs during the 2 years, the program achieved CN¥3,655.94 medical  savings per patient per year, and every ¥1 spent on the program led to ¥3.29 insavings. Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management. It also achieved relief of dyspnea symptoms and improvement in COPD's impact on quality of life. Conclusion The hospital-outreach PR program for patients with COPD achieved reductions in health-care utilization, monetary savings, and improvements in patient health outcomes. The effects of the program were sustained for at least 2 years. Trial Registration This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-TRC-14005108).",2020,"Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management.","['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with COPD (n=208', 'Patients with Chronic Obstructive Pulmonary Disease']","['routine care, including discharge education and a self-management education brochure', 'Hospital-Outreach Pulmonary Rehabilitation', '3-month intensive intervention, including supervised physical exercise, smoking cessation, self-management education, and psychosocial support, followed by long-term access to a nurse through telephone follow-up and home visits up to 24 months', 'Hospital-outreach pulmonary rehabilitation (PR', 'hospital-outreach PR program', 'hospital-outreach PR program (treatment) or treatment as usual (control']","['health-care utilization (ie, readmission rates, times, and days, and emergency department visits) and medical costs', 'quality of life', 'health-care utilization, monetary savings, and improvements in patient health outcomes', 'lung function (ie, FEV 1 , FEV 1 % predicted, FVC), dyspnea (mMCR), exercise capacity (6MWD), impact on quality of life (CAT), and self-management (CSMS', 'relief of dyspnea symptoms', 'FEV 1 , FEV 1 % predicted, exercise capacity, and self-management', 'lower readmission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",208.0,0.0443092,"Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management.","[{'ForeName': 'Aidi', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Lianhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The First Affiliated Hospital of Zunyi Medical University, Zunyi 563003, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Respiratory Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Sucui', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Xiaowan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Center for Health Policy and Management, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S239841'] 2547,32523380,Development and Validation of Pre- and Post-Operative Models to Predict Recurrence After Resection of Solitary Hepatocellular Carcinoma: A Multi-Institutional Study.,"Background The ideal candidates for resection are patients with solitary hepatocellular carcinoma (HCC); however, postoperative recurrence rate remains high. We aimed to establish prognostic models to predict HCC recurrence based on readily accessible clinical parameters and multi-institutional databases. Patients and Methods A total of 485 patients undergoing curative resection for solitary HCC were recruited from two independent institutions and the Cancer Imaging Archive database. We randomly divided the patients into training (n=323) and validation cohorts (n=162). Two models were developed: one using pre-operative and one using pre- and post-operative parameters. Performance of the models was compared with staging systems. Results Using multivariable analysis, albumin-bilirubin grade, serum alpha-fetoprotein and tumor size were selected into the pre-operative model; albumin-bilirubin grade, serum alpha-fetoprotein, tumor size, microvascular invasion and cirrhosis were selected into the postoperative model. The two models exhibited better discriminative ability (concordance index: 0.673-0.728) and lower prediction error (integrated Brier score: 0.169-0.188) than currently used staging systems for predicting recurrence in both cohorts. Both models stratified patients into low- and high-risk subgroups of recurrence with distinct recurrence patterns. Conclusion The two models with corresponding user-friendly calculators are useful tools to predict recurrence before and after resection that may facilitate individualized management of solitary HCC.",2020,The two models exhibited better discriminative ability (concordance index: 0.673-0.728) and lower prediction error (integrated Brier score: 0.169-0.188) than currently used staging systems for predicting recurrence in both cohorts.,"['485 patients undergoing curative resection for solitary HCC were recruited from two independent institutions and the Cancer Imaging Archive database', 'Solitary Hepatocellular Carcinoma', 'patients with solitary hepatocellular carcinoma (HCC']",[],"['discriminative ability', 'albumin-bilirubin grade, serum alpha-fetoprotein and tumor size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0373538', 'cui_str': 'Alpha-1-fetoprotein measurement, serum'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]",485.0,0.026273,The two models exhibited better discriminative ability (concordance index: 0.673-0.728) and lower prediction error (integrated Brier score: 0.169-0.188) than currently used staging systems for predicting recurrence in both cohorts.,"[{'ForeName': 'Ming-Yu', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': ""Department of Hepatobiliary Surgery, Wuxi People's Hospital, Wuxi, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': ""Department of Hepatobiliary Surgery, Wuxi People's Hospital, Wuxi, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Gu-Wei', 'Initials': 'GW', 'LastName': 'Ji', 'Affiliation': ""Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': ""Department of Hepatobiliary Surgery, Wuxi People's Hospital, Wuxi, People's Republic of China.""}, {'ForeName': 'Xiang-Cheng', 'Initials': 'XC', 'LastName': 'Li', 'Affiliation': ""Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S251413'] 2548,32523510,Transcutaneous Vagus Nerve Stimulation May Enhance Only Specific Aspects of the Core Executive Functions. A Randomized Crossover Trial.,"Background Individuals are able to perform goal-directed behaviors thanks to executive functions. According to the neurovisceral integration model, executive functions are upregulated by brain areas such as the prefrontal and cingulate cortices, which are also crucially involved in controlling cardiac vagal activity. An array of neuroimaging studies already showed that these same brain areas are activated by transcutaneous vagus nerve stimulation (tVNS). Despite evidence toward effects of tVNS on specific executive functions such as inhibitory control, there have been no studies investigating what type of inhibition is improved by tVNS by systematically addressing them within the same experiment. Furthermore, the effect of tVNS on another core executive function, cognitive flexibility, has not yet been investigated. Objective We investigated the effects of tVNS on core executive functions such as inhibitory control and cognitive flexibility. Methods Thirty-two participants (nine women, M age = 23.17) took part in this study. Vagally mediated heart rate variability parameters (root mean square of successive differences, RMSSD, and high frequency, HF) were measured while participants performed four different cognitive tasks that mainly rely on different aspects of both the aforementioned executive functions. Results Despite clear conflict effects in the four tasks, only performance on the task used to measure set-shifting paradigm was improved by tVNS, with switch costs being lower during tVNS than during sham stimulation. Furthermore, HF increased during each of the cognitive flexibility tasks, although HF during tVNS did not differ from HF during sham stimulation. Conclusion The results indicate for the first time (a) that tVNS can increase cognitive flexibility in a set-shifting paradigm, and (b) that tVNS may exert a stronger effect on cognitive flexibility than inhibition. The present study provides only partial evidence for the neurovisceral integration model. Future studies should address further paradigms that demand cognitive flexibility, thus investigating this new hypothesis on the specificity of the tVNS effects on cognitive flexibility.",2020,An array of neuroimaging studies already showed that these same brain areas are activated by transcutaneous vagus nerve stimulation (tVNS).,"['Methods\n\n\nThirty-two participants (nine women, M age = 23.17) took part in this study']",['tVNS'],"['heart rate variability parameters (root mean square of successive differences, RMSSD, and high frequency, HF', 'cognitive flexibility']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",32.0,0.0211423,An array of neuroimaging studies already showed that these same brain areas are activated by transcutaneous vagus nerve stimulation (tVNS).,"[{'ForeName': 'Uirassu', 'Initials': 'U', 'LastName': 'Borges', 'Affiliation': 'Institute of Psychology, German Sport University, Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Knops', 'Affiliation': 'Institute of Clinical Neuroscience and Medical Psychology, Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Laborde', 'Affiliation': 'Institute of Psychology, German Sport University, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Klatt', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Raab', 'Affiliation': 'Institute of Psychology, German Sport University, Cologne, Germany.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00523'] 2549,32523714,"Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.","Setting Bariatric surgery is indicated for patients diagnosed with obesity and type 2 diabetes. Many patients achieve type 2 diabetes remission soon after bariatric surgery. Even though most maintain good glycemic control, remission is not maintained in all patients, and as a result, some patients may relapse. Type 2 diabetes relapse is common in patients who regain weight; weight regain is prevalent 1 to 2 years after surgery. Additional pharmacotherapy may be required to aid bariatric surgery in fostering weight loss and reducing blood glucose levels. Objectives The purpose of this clinical trial was to determine the effects of canagliflozin in participants who initially achieved type 2 diabetes remission but subsequently relapsed. Methods The double-blinded, randomized, and prospective study recruited participants (n = 16) roughly 3 years after bariatric surgery. The participants were followed for 6 months. Results Body mass index (-1.24 kg/m 2 ) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo. There were improvements in body fat composition as denoted by reductions in android (-3.00%) and truncal (-2.67%) fat. Also, there were differences in blood glucose and hemoglobin A1C at 6 months. Conclusion After bariatric surgery, canagliflozin improved weight loss and glycemic outcomes in participants with type 2 diabetes. Canagliflozin also facilitated improvements in body fat composition.",2020,"Results Body mass index (-1.24 kg/m 2 ) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo.","['after bariatric surgery', 'participants who initially achieved type 2 diabetes remission but subsequently relapsed', 'participants with type 2 diabetes', 'participants (n = 16) roughly 3 years after bariatric surgery', 'patients diagnosed with obesity and type 2 diabetes']","['Canagliflozin', 'canagliflozin therapy versus placebo', 'canagliflozin', 'bariatric surgery, canagliflozin']","['Results\n\n\nBody mass index', 'body weight', 'body fat composition', 'blood glucose and hemoglobin A1C', 'weight loss and glycemic outcomes']","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",16.0,0.137241,"Results Body mass index (-1.24 kg/m 2 ) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo.","[{'ForeName': 'Sangeeta R', 'Initials': 'SR', 'LastName': 'Kashyap', 'Affiliation': 'Endocrinology and Metabolism Institute Cleveland Clinic Cleveland Ohio.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Kheniser', 'Affiliation': 'Endocrinology and Metabolism Institute Cleveland Clinic Cleveland Ohio.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Bariatric and Metabolic Institute Cleveland Clinic Cleveland Ohio.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Schauer', 'Affiliation': 'Bariatric and Metabolic Institute Cleveland Clinic Cleveland Ohio.'}, {'ForeName': 'Carel', 'Initials': 'C', 'LastName': 'Le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute University College Dublin Dublin Ireland.'}, {'ForeName': 'Bartolome', 'Initials': 'B', 'LastName': 'Burguera', 'Affiliation': 'Endocrinology and Metabolism Institute Cleveland Clinic Cleveland Ohio.'}]",Obesity science & practice,['10.1002/osp4.409'] 2550,32523715,"Examining barriers, physical activity, and weight change among parents and nonparents in a weight loss intervention.","Introduction Little is known about the influence of children in the home on physical activity and weight among adults in weight loss interventions. This study evaluated the association between number of children in the home, weight loss, and weight regain in a behavioural weight loss intervention, and whether those relationships were mediated in sequence by physical activity barriers and physical activity changes. Methods The sample included 267 participants from a randomized trial who had complete data on study variables. Variables at baseline, 6, and 18 months included physical activity barriers, objectively measured minutes of moderate-to-vigorous physical activity (MVPA), and objectively measured weight used to calculate percent weight loss (PWL) from baseline to 6 months and percent weight regained (PWG) from 6 to 18 months. Results A greater number of children in the home was associated with less PWL at 6 months. This relationship was mediated by greater baseline physical activity barriers and a smaller increase in MVPA at 6 months. The mediated effect was no longer significant when controlling for changes in dietary intake. There was no relationship between number of children and PWG from 6 to 18 months. Conclusions Parents may need unique intervention supports to overcome barriers to initiation of physical activity to help them reach optimal weight loss.",2020,The mediated effect was no longer significant when controlling for changes in dietary intake.,['267 participants from a randomized trial who had complete data on study variables'],[],"['physical activity barriers, objectively measured minutes of moderate-to-vigorous physical activity (MVPA), and objectively measured weight used to calculate percent weight loss (PWL']","[{'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",267.0,0.0265904,The mediated effect was no longer significant when controlling for changes in dietary intake.,"[{'ForeName': 'Brooke T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition University of North Carolina at Chapel Hill North Carolina.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, Healthy Lifestyle Institute, Physical Activity and Weight Management Research Center University of Pittsburgh Pittsburgh Pennsylvania.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': 'UniversitätsSpital Zürich, Zentrum Alter und Mobilität Stadtspital Waid Zurich Switzerland.'}, {'ForeName': 'Kelliann', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Department of Health and Physical Activity, Physical Activity and Weight Management Research Center University of Pittsburgh Pittsburgh Pennsylvania.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Departments of Health Behavior and Nutrition University of North Carolina at Chapel Hill North Carolina.'}]",Obesity science & practice,['10.1002/osp4.401'] 2551,32523717,"Modeling interactions between brain function, diet adherence behaviors, and weight loss success.","Introduction Obesity is linked to altered activation in reward and control brain circuitry; however, the associated brain activity related to successful or unsuccessful weight loss (WL) is unclear. Methods Adults with obesity (N = 75) completed a baseline functional magnetic resonance imaging (fMRI) scan before entering a WL intervention (ie,3-month diet and physical activity [PA] program). We conducted an exploratory analysis to identify the contributions of baseline brain activation, adherence behavior patterns, and the associated connections to WL at the conclusion of a 3-month WL intervention. Food cue-reactivity brain regions were functionally identified using fMRI to index brain activation to food vs nonfood cues. Food consumption, PA, and class attendance were collected weekly during the 3-month intervention. Results The left middle frontal gyrus (L-MFG, BA 46) and right middle frontal gyrus (R-MFG; BA 9) were positively activated when viewing food compared with nonfood images. Structural equation modeling with bootstrapping was used to investigate a hypothesized path model and revealed the following significant paths: (1) attendance to 3-month WL, (2) R-MFG to attendance, and (3) indirect effects of R-MFG through attendance on WL. Conclusion Findings suggest that brain activation to appetitive food cues predicts future WL through mediating session attendance, diet, and PA. This study contributes to the growing evidence of the importance of food cue reactivity and self-regulation brain regions and their impact on WL outcomes.",2020,"The left middle frontal gyrus (L-MFG, BA 46) and right middle frontal gyrus (R-MFG; BA 9) were positively activated when viewing food compared with nonfood images.",['Adults with obesity (N = 75'],"['baseline functional magnetic resonance imaging (fMRI) scan before entering a WL intervention (ie,3-month diet and physical activity [PA] program']","['Food consumption, PA, and class attendance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",75.0,0.0224824,"The left middle frontal gyrus (L-MFG, BA 46) and right middle frontal gyrus (R-MFG; BA 9) were positively activated when viewing food compared with nonfood images.","[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health Health University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Hung-Wen', 'Initials': 'HW', 'LastName': 'Yeh', 'Affiliation': 'Department of Biostatistics University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Graduate School of Social Work University of Denver Denver Colorado.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Lepping', 'Affiliation': 'Hoglund Brain Imaging Center University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Trisha M', 'Initials': 'TM', 'LastName': 'Patrician', 'Affiliation': 'Department of Biostatistics University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Florance J', 'Initials': 'FJ', 'LastName': 'Breslin', 'Affiliation': 'Center for Brain, Biology and Behavior University of Nebraska-Lincoln Lincoln Nebraska.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine University of Kansas Medical Center Kansas City Kansas.'}, {'ForeName': 'Cary R', 'Initials': 'CR', 'LastName': 'Savage', 'Affiliation': 'Department of Biostatistics University of Kansas Medical Center Kansas City Kansas.'}]",Obesity science & practice,['10.1002/osp4.403'] 2552,32523720,Exercise plus caloric restriction lowers soluble RAGE in adults with chronic kidney disease.,"Introduction The incidence of chronic kidney disease (CKD) has increased in recent years. CKD is associated with obesity, type 2 diabetes, and cardiovascular disease, although the mechanism remains unclear. Elevated soluble form of the receptor for advanced glycation end products ( RAGE) is related to proinflammatory signaling pathways that may promote diabetic nephropathy and vascular dysfunction. Because lifestyle modification reduces systematic inflammation in adults with obesity and hyperglycaemia, the hypothesis that exercise plus caloric restriction would lower soluble RAGE in adults with CKD was tested in this study. Methods Eight adults (n = 6 females; age: 56.3 ± 2.8 y; BMI: 43.7 ± 2.2 kg/m 2 ; 2-h OGTT glucose: 215 ± 9.8 mg/dL; eGFR: 49.6 ± 3.3 mL/min/1.73 m 2 ) were enrolled in a 12-week pilot lifestyle intervention (supervised aerobic exercise [5 d/wk, up to 60 min/d at approximately 65%-85% HR max ] plus low-fat dietary counseling). Body composition (DXA), aerobic fitness (VO 2 max), insulin sensitivity (120 min 75 g OGTT; Matsuda Index), plasma levels of soluble RAGE and fetuin-A were measured before and after the intervention. Results Exercise reduced body weight, fasting glucose, and fetuin-A as well as increased VO 2 max, glucose tolerance, and insulin sensitivity (all P < .05). Lifestyle intervention decreased plasma soluble RAGE (pre: 1018.1 ± 163 vs post: 810.6 ± 119.6 ng/mL; P = .02), and the decrease was associated with a lower 2-hour blood glucose ( r = 0.76, P = .03) and with increased insulin sensitivity ( r = -0.90, P < .01). Conclusions Exercise and caloric restriction are effective at lowering soluble RAGE in relation to glucose regulation in patients with CKD.",2020,"Lifestyle intervention decreased plasma soluble RAGE (pre: 1018.1 ± 163 vs post: 810.6 ± 119.6 ng/mL; P = .02), and the decrease was associated with a lower 2-hour blood glucose (","['Methods\n\n\nEight adults (n = 6 females; age: 56.3 ± 2.8 y; BMI: 43.7 ± 2.2 kg/m 2 ; 2-h OGTT glucose: 215 ± 9.8 mg/dL; eGFR: 49.6 ± 3.3 mL/min/1.73 m 2 ', 'adults with obesity and hyperglycaemia', 'patients with CKD', 'adults with chronic kidney disease', 'adults with CKD']","['pilot lifestyle intervention (supervised aerobic exercise', 'CKD', 'Exercise plus caloric restriction']","['plasma soluble RAGE', 'Body composition (DXA), aerobic fitness (VO 2 max), insulin sensitivity (120 min 75 g OGTT; Matsuda Index), plasma levels of soluble RAGE and fetuin-A', 'soluble RAGE', 'insulin sensitivity', 'body weight, fasting glucose, and fetuin-A as well as increased VO 2 max, glucose tolerance, and insulin sensitivity', '2-hour blood glucose ', 'chronic kidney disease (CKD']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",8.0,0.0221929,"Lifestyle intervention decreased plasma soluble RAGE (pre: 1018.1 ± 163 vs post: 810.6 ± 119.6 ng/mL; P = .02), and the decrease was associated with a lower 2-hour blood glucose (","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology University of Virginia Charlottesville VA USA.'}, {'ForeName': 'Sankar D', 'Initials': 'SD', 'LastName': 'Navaneethan', 'Affiliation': 'Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine Baylor College of Medicine Houston TX USA.'}, {'ForeName': 'Ciaran E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Department of Pathobiology, Lerner Research Institute Cleveland Clinic Cleveland OH USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Scelsi', 'Affiliation': 'Department of Pathobiology, Lerner Research Institute Cleveland Clinic Cleveland OH USA.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Pathobiology, Lerner Research Institute Cleveland Clinic Cleveland OH USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rocco', 'Affiliation': 'Heart and Vascular Institute Cleveland Clinic Cleveland OH USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center Louisiana State University Baton Rouge LA USA.'}]",Obesity science & practice,['10.1002/osp4.408'] 2553,32523839,L-Carnitine as a Diet Supplement in Patients With Type II Diabetes.,"INTRODUCTION L-Carnitine is a very important component of the human body which is involved in cardiac function and generally in the proper functioning of the muscular system. Also, it contributes to the proper use of glucose by the cell, thereby improving the regulation of glucose metabolism of the diabetic patient and preventing complications such as fatigue, insomnia, and mental activity. In this paper we would like to show the therapeutic effect of L-carnitine on type II diabetic patients after 2 g/day oral administration of L-carnitine. METHODS In this study 181 Greek patients, 84 men and 97 women, aged 50-65 years, Type II diabetics, were administered L-carnitine for six months. All of them were euglycemic, under the proposed treatment, with no diabetic complications or cardiovascular problems. They were under the Mediterranean diet trying to keep their body mass index (BMI) constant. They were neither smokers nor alcohol drinkers. They were administered 2 g/day L-carnitine, orally, once daily for six months, on an empty stomach. The blood tests included fasting glucose, glycated hemoglobin (HBA1c), total cholesterol, and triglycerides and they were performed before, three months after, and six months after the treatment initiation. We also evaluated their tiredness, insomnia, and mental activity at these time points; the participants were given forms to fill out (regarding the distance they are able to brisk walk thrice/week, the duration of their calm uninterrupted sleep and their performance in a cognitive screening test, respectively) and based on the results of their answers, they were allocated to graded groups and scale analysis was performed in each one of them. RESULTS Fasting glucose mean decrease was 17.51 after three months of medication (p<0.05); the decrease though noted after six months was not statistically significant. HbA1c showed a statistically significant mean decrease in both three- and six-month milestones (0.335, p<0.05 and 0.623, p<0.05 respectively). Changes noted in cholesterol levels were not statistically significant. Triglyceride measurements showed a significant decrease; -15.38 after three months (p<0.05) and -31.39 after six months of treatment (p<0.05). Finally, significant changes were found in both time periods for tiredness (three months: -0.49, p<0.05, six months: -0.88, p<0.05), insomnia (three months: -0.49, p<0.05, six months: -0.88, p<0.05), and mental activity (three months: +0.25, p<0.05, six months: +0.89, p<0.05). CONCLUSION L-Carnitine could be a valuable dietary supplement in patients with type II diabetes who follow a Mediterranean diet and are under recommended treatment. Research in this field though is at an early stage and more studies should be performed.",2020,"RESULTS Fasting glucose mean decrease was 17.51 after three months of medication (p<0.05); the decrease though noted after six months was not statistically significant.","['181 Greek patients, 84 men and 97 women, aged 50-65 years, Type II diabetics', 'Patients With Type II Diabetes', 'patients with type II diabetes who follow a Mediterranean diet and are under recommended treatment']","['L-Carnitine', 'L-carnitine']","['cholesterol levels', 'mental activity', 'diabetic complications or cardiovascular problems', 'Fasting glucose mean decrease', 'Triglyceride measurements', 'insomnia', 'tiredness, insomnia, and mental activity', 'time periods for tiredness', 'blood tests included fasting glucose, glycated hemoglobin\xa0(HBA1c), total cholesterol, and triglycerides']","[{'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",181.0,0.0188419,"RESULTS Fasting glucose mean decrease was 17.51 after three months of medication (p<0.05); the decrease though noted after six months was not statistically significant.","[{'ForeName': 'Dimitrios T', 'Initials': 'DT', 'LastName': 'Karalis', 'Affiliation': 'Nutrition and Dietetics, University of Thessaly, Volos, GRC.'}, {'ForeName': 'Tilemachos', 'Initials': 'T', 'LastName': 'Karalis', 'Affiliation': 'Obstetrics and Gynecology, General Hospital of Trikala, Trikala, GRC.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Karalis', 'Affiliation': 'Internal Medicine, General Hospital of Trikala, Trikala, GRC.'}, {'ForeName': 'Angeliki S', 'Initials': 'AS', 'LastName': 'Kleisiari', 'Affiliation': 'Nutrition and Dietetics, University of Thessaly, Trikala, GRC.'}]",Cureus,['10.7759/cureus.7982'] 2554,32523873,A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial.,"Adjustment disorder with anxiety (ADA) is a common psychiatric pathology worldwide, but it is often undertreated. Cognitive behavioral therapy (CBT) is the first-line treatment, but very few studies have been carried out for the treatment of ADA. Internet-delivered CBT (iCBT) appears to be an effective treatment option, with the potential to reach a larger proportion of individuals suffering from ADA. Guidance is a beneficial feature of iCBT, provided in most studies by email or telephone (traditional guided iCBT). Blended CBT, which combines an online intervention and therapeutic guidance provided in person (face-to-face), could be a way to benefit from both the advantages of face-to-face CBT regarding human interactional quality and the advantages of internet-based CBT in terms of improved access to treatment. In this randomized controlled trial, the effectiveness of two forms of administration of Seren@ctif , a 5-week CBT program for patients with ADA according the DSM-5, was examined: one delivered through face-to-face sessions (face-to-face CBT) and the other delivered online and guided with face-to-face contact with a nurse (blended CBT); these formats were compared with a wait-list control group (WLC). A total of 120 patients were included and randomized to one of these three conditions. Measures were administered before treatment, after treatment and 6 months after inclusion in the study. Both treatment conditions displayed significant decreases in anxiety, depression, worry and perceived stress at posttreatment when compared to the WLC group. The decrease in symptoms was mostly maintained 6 months after inclusion for the two experimental groups. Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures. We conclude that both face-to-face CBT and blended CBT are effective treatments for patients with ADA, and we suggest that blended CBT may be slightly more effective than classical face-to-face CBT. Trial Registration: Clinicaltrials.gov NCT02621775;https://clinicaltrials.gov/ct2/show/NCT02621775(Archived by WebCite at http://www.webcitation.org/6tQrkPs1u).",2020,Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures.,"['patients with ADA according the DSM-5', 'A total of 120 patients', 'patients with adjustment disorder with anxiety', 'patients with ADA', 'Adjustment disorder with anxiety (ADA']","['Internet-delivered CBT (iCBT', 'Seren@ctif , a 5-week CBT program', 'blended cognitive behavioral intervention', 'online and guided with face-to-face contact with a nurse (blended CBT); these formats were compared with a wait-list control group (WLC', 'Cognitive behavioral therapy (CBT', 'Blended CBT']","['anxiety, depression, worry and perceived stress', 'anxiety and depression', 'symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154587', 'cui_str': 'Adjustment disorder with anxious mood'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.0349629,Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures.,"[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Leterme', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Behal', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Demarty', 'Affiliation': ""Univ. Lille, Inserm, CHU Lille, CIC1403 - Centre d'Investigation Clinique, F-59000 Lille, France.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Barasino', 'Affiliation': 'Stress and Anxiety Unit, Department of Psychiatry, Lille University Hospital, Lille, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rougegrez', 'Affiliation': 'Stress and Anxiety Unit, Department of Psychiatry, Lille University Hospital, Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vaiva', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Servant', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}]",Internet interventions,['10.1016/j.invent.2020.100329'] 2555,32523878,Therapeutic effects of HESA-A (a herbal-marine compound) in acute organophosphorus pesticide poisoning.,"Objective Organophosphorus compounds (OPs) are common causes of poisonings. Atropine and oximes are pharmacological antidotes of OPs. However, because of their adverse effects and insufficient performance, several other compounds have been evaluated as adjuvant therapy. HESA-A is a herbal-marine drug that contains material from Carum carvi  (Persian cumin),  Penaeus latisculatus  (king prawn), and  Apium graveolens (celery) with anti-inflammatory and antioxidants properties, which has shown useful effects as adjuvant therapy on some diseases. We have evaluated the effect of HESA-A on 69 moderate to severe acute OPs poisoned patients (44 HESA-A treated and 25 controls) as an adjuvant drug. Materials and Methods Two randomized age and sex matched groups of OPs poisoned patients were treated in Medical Toxicology Center of Imam Reza hospital, Mashhad, by conventional therapy with or without HESA-A (50 mg/kg/day orally). The evaluation criteria were total administrated doses of atropine and pralidoxime, intensive care unit (ICU) admission rate, mechanical respiration need, number of hospitalization days and mortality. Results There were no significant differences between the morbidity and mortality rate criteria of the two groups; moreover, we did not observe significant adverse effects for HESA-A. Conclusion HESA-A did not reduce morbidity and mortality of OPs poisoning and did not induce any major side effect in the patients.",2020,"There were no significant differences between the morbidity and mortality rate criteria of the two groups; moreover, we did not observe significant adverse effects for HESA-A. Conclusion HESA-A did not reduce morbidity and mortality of OPs poisoning and did not induce any major side effect in the patients.","['acute organophosphorus pesticide poisoning', '69 moderate to severe acute OPs poisoned patients (44 HESA-A treated and 25 controls) as an adjuvant drug']","['HESA-A (a herbal-marine compound', 'atropine and pralidoxime', 'Medical Toxicology Center of Imam Reza hospital, Mashhad, by conventional therapy with or without HESA-A', 'HESA-A', 'Atropine and oximes']","['morbidity and mortality of OPs poisoning', 'intensive care unit (ICU) admission rate, mechanical respiration need, number of hospitalization days and mortality', 'morbidity and mortality rate criteria']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0275009', 'cui_str': 'Pesticide poisoning'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029254', 'cui_str': 'Organic phosphorus compound'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0071808', 'cui_str': 'pralidoxime'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030020', 'cui_str': 'Oxime'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0029254', 'cui_str': 'Organic phosphorus compound'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",2.0,0.076527,"There were no significant differences between the morbidity and mortality rate criteria of the two groups; moreover, we did not observe significant adverse effects for HESA-A. Conclusion HESA-A did not reduce morbidity and mortality of OPs poisoning and did not induce any major side effect in the patients.","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mousavi', 'Affiliation': 'Medical Toxicology Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Moshiri', 'Affiliation': 'Medical Toxicology Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Emadodin', 'Initials': 'E', 'LastName': 'Darchini-Maragheh', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Emam Reza Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Khosro', 'Initials': 'SK', 'LastName': 'Ghasempouri', 'Affiliation': 'Department of Forensic Medicine and Toxicology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Dadpour', 'Affiliation': 'Medical Toxicology Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Sardar Antighechi', 'Affiliation': 'Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Balali-Mood', 'Affiliation': 'Medical Toxicology and Drug Abuse Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]",Avicenna journal of phytomedicine,[] 2556,32523884,"Effects of Valeriana officinalis (Valerian) on tension-type headache: A randomized, placebo-controlled, double-blind clinical trial.","Objective Tension-type headache is the most frequent type of headache. Considering the effectiveness of Valeriana officinalis (Valerian) in treatment of some types of headache, the effect of valerian root was studied in patients with tension-type headache. Materials and Methods The current study is a double-blind randomized clinical trial that was conducted in Shams Hospital of Mashhad University of Medical Sciences, Mashhad, Iran, from January to June 2018. We included 88 participants with tension-type headache and randomly assigned them to intervention and control group by block randomization in a 1:1 ratio. The intervention group received Sedamin® capsule (530 mg of valerian root extraction) while the placebo group received 500 mg of breadcrumbs both given as two capsules daily for a month -after dinner. The headache impact on activity of daily livings performance, headache disability, and headache severity were measured using questionnaires in baseline and one month after intervention in both groups. Results The average age (±SD) of the participants was 34.9 (±8.7) years old. After one month, the impact of headache on daily livings performance, significantly reduced in intervention group (mean=51.2) versus the placebo (mean=57.0), (p<0.001). There was a significant reduction in disability in intervention group (mean=22.9) compared to the placebo (mean=27.4) (p<0.001) and the severity score showed significant reductions in intervention group (mean=3.5) versus the placebo group (mean=5.1) (p<0.001). Conclusion The present trial showed that valerian capsule could reduce the headache impact on daily livings performance, disability and severity of tension-type headache.",2020,"After one month, the impact of headache on daily livings performance, significantly reduced in intervention group (mean=51.2) versus the placebo (mean=57.0), (p<0.001).","['88 participants with tension-type headache and randomly assigned them to', 'The average age (±SD) of the participants was 34.9 (±8.7) years old', 'patients with tension-type headache', 'Shams Hospital of Mashhad University of Medical Sciences, Mashhad, Iran, from January to June 2018']","['Sedamin® capsule', 'intervention and control group by block randomization', 'Valeriana officinalis (Valerian', 'placebo']","['severity score', 'tension-type headache', 'headache on daily livings performance', 'disability', 'headache impact on daily livings performance, disability and severity of tension-type headache', 'headache impact on activity of daily livings performance, headache disability, and headache severity']","[{'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0993600', 'cui_str': 'Valeriana officinalis'}, {'cui': 'C0042281', 'cui_str': 'Valeriana'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",88.0,0.441066,"After one month, the impact of headache on daily livings performance, significantly reduced in intervention group (mean=51.2) versus the placebo (mean=57.0), (p<0.001).","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Azizi', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Asie', 'Initials': 'A', 'LastName': 'Shojaii', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Hashem-Dabaghian', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Noras', 'Affiliation': 'Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Boroumand', 'Affiliation': 'Department of Neurology, Shams Hospital, Mashhad, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Ebadolahzadeh Haghani', 'Affiliation': 'Faculty of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Ghods', 'Affiliation': 'Research Institute for Islamic and Complementary Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Avicenna journal of phytomedicine,[] 2557,32524054,Daily listening to Mozart reduces seizures in individuals with epilepsy: A randomized control study.,"Objective Epilepsy is one of the most common neurological disorders . Many individuals continue to have seizures despite medical and surgical treatments, suggesting adjunctive management strategies are required. Promising effects of daily listening to Mozart on reducing seizure frequency in individuals with epilepsy have been demonstrated over the last 20 years, but not in a rigorously controlled manner. In this study, we compared the effect on seizure frequency of daily listening to either Mozart K.448 or a spectrally similar, yet non-rhythmic control piece. We hypothesized that there would be no difference in seizure counts when participants listened to Mozart K.448 vs when they listened to the control piece. Methods We employed a randomized crossover design, in which each participant was exposed to both three months of daily listening to the first six minutes of Sonata for two pianos in D major by Mozart (Mozart K.448; treatment period) and three months of daily listening to phase-scrambled version (control period). There was a three-month baseline and a three-month follow-up period before and after the six-month listening period, respectively. Change in seizure counts obtained from the seizure diaries was considered as the main study outcome. Results Using three methodologies to investigate the existence of the treatment effect (paired t test, estimation statistics and plots, and Cohen's d ), our results revealed a reduction in seizure counts during the treatment period, which was not observed for the control period ( P-value  < .001). Significance Using a spectrally similar control piece, our study advances previous reports that were limited by a ""no music"" control condition. Daily listening to Mozart K.448 was associated with reducing seizure frequency in adult individuals with epilepsy. These results suggest that daily Mozart listening may be considered as an adjunctive therapeutic option to reduce seizure burden in individuals with epilepsy.",2020,Daily listening to Mozart K.448 was associated with reducing seizure frequency in adult individuals with epilepsy.,"['individuals with epilepsy', 'adult individuals with epilepsy']","['Daily listening to Mozart', 'daily listening to Mozart']","['seizure frequency', 'seizure counts']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.250683,Daily listening to Mozart K.448 was associated with reducing seizure frequency in adult individuals with epilepsy.,"[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Rafiee', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Kramay', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Groppe', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Andrade', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Bercovici', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Carlen', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tai', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Weaver', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wennberg', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}, {'ForeName': 'Taufik A', 'Initials': 'TA', 'LastName': 'Valiante', 'Affiliation': 'Krembil Brain Institute Toronto ON Canada.'}]",Epilepsia open,['10.1002/epi4.12400'] 2558,32524118,[Effect of ultrasonic scaling on micro-leakage of all-ceramic crowns].,"PURPOSE To investigate the effect of ultrasonic scaling on micro-leakage of all-ceramic crowns. METHODS 48 first premolars of the similar shape and size were collected and prepared by one attending doctor. Two groups were randomly divided (zirconia crown group and glass ceramic crown group, with 24 in each group), and each group was randomly divided into two subgroups (resin cement group and resin modified glass cement subgroup, n=6). After the crowns were bonded and solidified for 24 h, 3 samples were randomly selected from each subgroup for ultrasonic scaling for 60 s, and the other 3 samples were used as the negative control group. After all samples were soaked in 5% fuchsin solution at room temperature for 48 h, buccal and lingual incisions were made, and double-blind scoring was performed for micro-leakage at the crown edge of each sample. SPSS 17.0 software package was used for statistical analysis. RESULTS There were significant differences between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin modified glass cement(P<0.05), but there was no significant difference between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin cement(P>0.05). When the same adhesive was used, there was significant difference in microleakage between the zirconia crown and the glass-ceramic crown, whether ultrasonic supragingival scaling was performed or not(P<0.05). CONCLUSIONS Ultrasonic scaling had significant effect on micro-leakage of crowns which were cemented with resin modified glass cement, and but had no significant effect on micro-leakage of crowns which were cemented with resin cement.",2020,"There were significant differences between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin modified glass cement(P<0.05), but there was no significant difference between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin cement(P>0.05).",['48 first premolars of the similar shape and size were collected and prepared by one attending doctor'],"['ultrasonic scaling', 'zirconia crown group and glass ceramic crown', 'resin cement group and resin modified glass cement']","['micro-leakage', 'microleakage']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0440171', 'cui_str': 'Dental ceramic crown material'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",,0.0237634,"There were significant differences between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin modified glass cement(P<0.05), but there was no significant difference between the negative group and the ultrasonic group in micro-leakage of crowns which were cemented with resin cement(P>0.05).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'School and Hospital of Stomatology, Fujian Medical University; Fujian Biological Materials Engineering and Technology Center of Stomatology. Fuzhou 350002, China. E-mail:jiangleidentist@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Ya-Hong', 'Initials': 'YH', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ye-Xin', 'Initials': 'YX', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Chang-Yuan', 'Initials': 'CY', 'LastName': 'Zhang', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[] 2559,32524120,[Effect of dental varnish containing fluoride either with CPP-ACP or bioglass on root caries].,"PURPOSE To investigate the effect of dental varnish containing fluoride either with casein phosphopeptide-amorphous calcium phosphate(CPP-ACP) or bioglass on root caries. METHODS The active roots collected in Peking University People's Hospital from April 2017 to October 2018 were randomly divided into group A, group B, group C, and group D, each with 18 teeth. All groups received toothbrushing containing fluoride, in addition, group B received another 5% sodium fluoride, group C added 5% sodium fluoride + CPP-ACP, and group D added 5% sodium fluoride + bioglass. The severity, surface roughness and mineral concentration of root caries before and after brushing were observed. SPSS 23.0 software package was used to determine the correlation between root severity and surface roughness. RESULTS After 50 days of brushing, the hardness of group B, C and D was significantly improved (P<0.05), and was significantly better than that of group A (P<0.05). The hardness was the highest in group D after 50 days of brushing, followed by group C and B, with significant difference(P<0.05). The surface roughness scores of group B and C were significantly higher than those of group A and D after 7 days of brushing(P<0.05). The surface roughness scores of group B were significantly higher than those of group A, C and D after 14 days of brushing(P<0.05). The surface roughness scores of group D were significantly higher than those of group B and C after 50 days of brushing(P<0.05). The severity score of root caries in group A was negatively correlated with surface roughness (P<0.05). The mineral concentration of each group was increased 50 days after brushing (P<0.05). CONCLUSIONS Application of dental varnish containing fluoride either with CPP-ACP or bioglass can effectively prevent root caries. Compared with CPP-ACP, bioglass is more stable, and can effectively improve the mineral concentration on tooth surface.",2020,The surface roughness scores of group D were significantly higher than those of group B and C after 50 days of brushing(P<0.05).,"[""The active roots collected in Peking University People's Hospital from April 2017 to October 2018""]","['dental varnish containing fluoride either with CPP-ACP or bioglass', 'toothbrushing containing fluoride, in addition, group B received another 5% sodium fluoride, group C added 5% sodium fluoride + CPP-ACP, and group D added 5% sodium fluoride + bioglass', 'dental varnish containing fluoride either with casein phosphopeptide-amorphous calcium phosphate(CPP-ACP']","['mineral concentration', 'severity, surface roughness and mineral concentration of root caries', 'root caries', 'severity score of root caries', 'surface roughness scores']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0440150', 'cui_str': 'Dental varnish'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0053629', 'cui_str': 'Bioglass'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0176897,The surface roughness scores of group D were significantly higher than those of group B and C after 50 days of brushing(P<0.05).,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Stomatology, Peking University People's Hospital. Beijing 100044, China. E-mail:zhidu8858@163.com.""}, {'ForeName': 'Chen-Zhi', 'Initials': 'CZ', 'LastName': 'Gao', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[] 2560,32524129,"[Effects of dynamic nutrition support on energy metabolism, immune function and stress response after oral and maxillofacial tumor surgery].","PURPOSE To observe the effect of dynamic nutrition support on postoperative energy metabolism, immune function and stress response in patients with oral and maxillofacial tumors. METHODS Fifty-six patients with oral and maxillofacial tumor surgery were randomly divided into experimental group and control group (28 in each group). Patients in the experimental group received dynamic enteral and parenteral nutrition support according to the stress period after surgery, ω-3 fish oil fat milk injection and glutamine were added in the nutrition support program. Patients in the control group were given routine postoperative enteral and parenteral camp support. Energy metabolism, immune function and stress indexes were detected 1 day before surgery, 2 days after surgery and 7 days after surgery, respectively. SPSS 19.0 software package was used to analyze the data. RESULTS Energy metabolism indexes in the experimental group were higher than the control group on day 2 after PA surgery and day 7 after ALB and PA surgery, while energy metabolism indexes in the experimental group were lower than the control group on day 2 and day 7 after FPG and TG surgery with significant difference(P<0.05). The levels of IgA, IgG, IgM, CD3+, CD4+ and CD4+/CD8+ in the experimental group were higher than those in the control group 7 days after surgery, with significant differences (P<0.05). The levels of CRP, TNF- and IL-6 in the experimental group were lower than those in the control group 7 days after surgery, and the difference was significant(P<0.05). There was no significant difference in postoperative complications between the two groups. CONCLUSIONS Dynamic nutrition support can improve postoperative energy metabolism of patients with oral and maxillofacial tumors, improve immune function, and alleviate stress response.",2020,"The levels of CRP, TNF- and IL-6 in the experimental group were lower than those in the control group 7 days after surgery, and the difference was significant(P<0.05).","['Fifty-six patients with oral and maxillofacial tumor surgery', 'patients with oral and maxillofacial tumors']","['dynamic nutrition support', 'routine postoperative enteral and parenteral camp support', 'dynamic enteral and parenteral nutrition support according to the stress period after surgery, ω-3 fish oil fat milk injection and glutamine were added in the nutrition support program']","['postoperative energy metabolism', 'energy metabolism, immune function and stress response', 'levels of IgA, IgG, IgM, CD3+, CD4+ and CD4+/CD8', 'levels of CRP, TNF- and IL-6', 'postoperative energy metabolism, immune function and stress response', 'energy metabolism indexes', 'postoperative complications', 'Energy metabolism, immune function and stress indexes', 'Energy metabolism indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",56.0,0.0276141,"The levels of CRP, TNF- and IL-6 in the experimental group were lower than those in the control group 7 days after surgery, and the difference was significant(P<0.05).","[{'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Huo', 'Affiliation': 'Qingdao Central Hospital. Qingdao 266042, China. E-mail:jayh20@sina.com.'}, {'ForeName': 'Yong-Hai', 'Initials': 'YH', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yan-Pei', 'Initials': 'YP', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ning-Yi', 'Initials': 'NY', 'LastName': 'Li', 'Affiliation': ''}]",Shanghai kou qiang yi xue = Shanghai journal of stomatology,[] 2561,32524145,Clinical Efficacy of Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery for the Treatment of Allodynia Caused by Herpes Zoster.,"OBJECTIVE To investigate the efficacy of ultrasound-mediated drug delivery for allodynia caused by herpes zoster. DESIGN Unblinded randomized controlled study with two treatment groups and an additional control group. SUBJECTS Patients hospitalized with allodynia caused by herpes zoster were enrolled. METHODS Patients were randomly assigned to three groups: ultrasound-mediated transdermal drug delivery (group U), lidocaine intradermal injection (group I), or control group (group C). The primary outcome was pain intensity associated with allodynia, assessed with the visual analog scale (VAS) while brushing the skin with clothing after treatment stimulated allodynia. The secondary outcomes included an emotional functioning score (ES), average gabapentin consumption, and incidence of adverse events of each group. RESULTS Sixty patients were enrolled in the study, but two of them failed to complete the treatment process. Therefore, 58 patients were included in the final analysis. All groups had lower VAS and ES scores after treatment compared with baseline. The VAS scores in groups U and I decreased significantly more than in group C (P < 0.05). Mean VAS scores in group U on days 1, 2, and 3 were lower than in group C (P < 0.01). ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001). Average gabapentin consumption and incidence of adverse events in group C were higher than in the other two groups. CONCLUSIONS In this study of treatment of allodynia caused by herpetic zoster, ultrasound-mediated lidocaine and capsaicin delivery provided better pain relief and improved emotional functioning compared with intradermal blockade with local anesthetics.",2020,ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001).,"['Allodynia Caused by Herpes Zoster', '58 patients were included in the final analysis', 'Patients', 'Sixty patients', 'Patients hospitalized with allodynia caused by herpes zoster were enrolled']","['Ultrasound-Mediated Transdermal Lidocaine and Capsaicin Delivery', 'lidocaine intradermal injection', 'ultrasound-mediated drug delivery', 'ultrasound-mediated transdermal drug delivery', 'lidocaine and capsaicin']","['pain intensity associated with allodynia, assessed with the visual analog scale (VAS', 'ES', 'Average gabapentin consumption and incidence of adverse events', 'pain relief and improved emotional functioning', 'Mean VAS scores', 'VAS and ES scores', 'emotional functioning score (ES), average gabapentin consumption, and incidence of adverse events of each group', 'VAS scores']","[{'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",60.0,0.0551121,ES was significantly lower in group U compared with groups I and C after treatment (P < 0.001).,"[{'ForeName': 'Yue-E', 'Initials': 'YE', 'LastName': 'Dai', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Shao-Xing', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Chengdu Second People's Hospital, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Pain Management, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Yun-Xia', 'Initials': 'YX', 'LastName': 'Zuo', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, Sichuan, People's Republic of China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa137'] 2562,32524226,"Hypoxic training improves blood pressure, nitric oxide and hypoxia-inducible factor-1 alpha in hypertensive patients.","PURPOSE To examine the effects of intermittent hypoxic breathing at rest (IHR) or during exercise (IHT) on blood pressure and nitric oxide metabolites (NOx) and hypoxia-inducible factor-1 alpha levels (HIF-1α) over a 6-week period. METHODS 47 hypertensive patients were randomly allocated to three groups: hypertensive control (CON: n = 17; IHR: n = 15 and IHT: n = 15. The CON received no intervention; whereas, IH groups received eight events of hypoxia (F I O 2 0.14), and normoxia (F I O 2 0.21), 24-min hypoxia and 24-min normoxia, for 6 weeks. The baseline data were collected 2 days before the intervention; while, the post-test data were collected at days 2 and 28 after the 6-week intervention. RESULTS We observed a significant decrease of the SBP in both IH groups: IHR (- 12.0 ± 8.0 mmHg, p = 0.004 and - 9.9 ± 8.8 mmHg, p = 0.028, mean ± 95% CI) and IHT (- 13.0 ± 7.8 mmHg, p = 0.002 and - 10.0 ± 8.4 mmHg, p = 0.016) at days 2 and 28 post-intervention, respectively. Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001). At 2 days post-intervention, NOx and HIF-1α were negatively correlated with SBP in IHT. CONCLUSION IH programs may act as an alternative therapeutic strategy for hypertension patients probably through elevation of NOx and HIF-1α production.",2020,"Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001).","['hypertensive patients', 'hypertension patients', '47 hypertensive patients']","['Hypoxic training', 'intermittent hypoxic breathing at rest (IHR) or during exercise (IHT', 'hypertensive control (CON: n\u2009=\u200917; IHR: n\u2009=\u200915 and IHT: n\u2009=\u200915']","['blood pressure and nitric oxide metabolites (NOx) and hypoxia-inducible factor-1 alpha levels (HIF-1α', 'SBP', 'blood pressure, nitric oxide and hypoxia-inducible factor-1 alpha']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1528322', 'cui_str': 'HIF1A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",47.0,0.0282204,"Compared to CON, IHR and IHT had increased of NOx (IHR; 8.5 ± 7.6 μmol/L, p = 0.031 and IHT; 20.0 ± 9.1 μmol/L, p < 0.001) and HIF-1α (IHR; 170.0 ± 100.0 pg/mL, p = 0.002 and IHT; 340.5 ± 160.0 pg/mL, p < 0.001).","[{'ForeName': 'Nattha', 'Initials': 'N', 'LastName': 'Muangritdech', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hamlin', 'Affiliation': 'Department of Tourism, Sport and Society, Lincoln University, Lincoln, New Zealand.'}, {'ForeName': 'Kittisak', 'Initials': 'K', 'LastName': 'Sawanyawisuth', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Piya', 'Initials': 'P', 'LastName': 'Prajumwongs', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Wisutthida', 'Initials': 'W', 'LastName': 'Saengjan', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Preetiwat', 'Initials': 'P', 'LastName': 'Wonnabussapawich', 'Affiliation': 'Sport and Exercise Science Program, Faculty of Science and Technology, Nakhonratchasima Rajabhat University, Nakhon Ratchasima, Thailand.'}, {'ForeName': 'Nuttaset', 'Initials': 'N', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Apiwan', 'Initials': 'A', 'LastName': 'Manimmanakorn', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. mapiwa@kku.ac.th.'}]",European journal of applied physiology,['10.1007/s00421-020-04410-9'] 2563,32524230,Pharmacokinetics and bioavailability of hydroxytyrosol are dependent on the food matrix in humans.,"PURPOSE Several studies have demonstrated the properties of hydroxytyrosol, a phenolic compound present in olive oils and olives with a well-characterized impact on human health. Nevertheless, some knowledge gaps remain on its bioavailability and metabolism; overall concerning to the real rate per cent of absorption and biovailability of dietary hydroxytyrosol and the influence of the dietary food-containing hydroxytyrosol on it. METHODS A double-blind study was performed including 20 volunteers who ingested 5 mg of hydroxytyrosol through diverse food matrices, to discover the influence on pharmacokinetics and bioavailability of HT metabolites (hydroxytyrosol acetate, 3,4-dihydroxyphenylacetic acid (DOPAC), tyrosol, and homovanillic alcohol) of the distinct matrices by UHPLC-ESI-QqQ-MS/MS. RESULTS The HT pharmacokinetics after consumption of different food matrices was strongly dependent on the food matrix. In this aspect, the intake of extra virgin olive exhibited significantly higher plasma concentrations after 30 min of oral intake (3.79 ng/mL) relative to the control. Regarding the hydroxytyrosol bioavailability, the intake of extra virgin olive oil, as well as fortified refined olive, flax, and grapeseed oils provided significantly higher urinary contents (0.86, 0.63, 0.55, and 0.33 µg/mg creatinine, respectively) compared with basal urine, whereas hydroxytyrosol metabolites showed no significant changes. No differences were found between men and women. CONCLUSIONS The metabolic profile of hydroxytyrosol is influenced by the food matrix in which is incorporated, with the oily nature for the final bioavailability being relevant. Extra virgin olive oil was identified as the best matrix for this compound. The results described contribute to the understanding of the relevance of the food matrices for the final absorption of hydroxytyrosol and hence, the achievement of the highest health protection potential.",2020,"The results described contribute to the understanding of the relevance of the food matrices for the final absorption of hydroxytyrosol and hence, the achievement of the highest health protection potential.","['20 volunteers who ingested 5\xa0mg of', 'humans']","['Extra virgin olive oil', 'hydroxytyrosol']","['plasma concentrations', 'pharmacokinetics and bioavailability of HT metabolites (hydroxytyrosol acetate, 3,4-dihydroxyphenylacetic acid (DOPAC), tyrosol, and homovanillic alcohol) of the distinct matrices by UHPLC-ESI-QqQ-MS/MS', 'urinary contents']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0000376', 'cui_str': 'Dihydroxyphenylacetic acid'}, {'cui': 'C0048386', 'cui_str': '4-hydroxyphenylethanol'}, {'cui': 'C2605391', 'cui_str': 'homovanillic alcohol'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",20.0,0.0255358,"The results described contribute to the understanding of the relevance of the food matrices for the final absorption of hydroxytyrosol and hence, the achievement of the highest health protection potential.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Alemán-Jiménez', 'Affiliation': 'E.U. Human and Dietetic Nutrition, San Antonio Catholic University, Campus Los Jerónimos, s/n, 30107, Murcia, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Domínguez-Perles', 'Affiliation': 'Research Group on Quality, Safety, and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Edif. 25, 30100, Espinardo, Murcia, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety, and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Edif. 25, 30100, Espinardo, Murcia, Spain. smescudero@cebas.csic.es.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Prgomet', 'Affiliation': 'Centre for the Research and Technology of Agro-Environmental and Biological Sciences, CITAB, University of Trás-Os-Montes e Alto Douro, UTAD, Quinta de Prados, 5000-801, Vila Real, Portugal.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'López-González', 'Affiliation': 'Research Group on Quality, Safety, and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Edif. 25, 30100, Espinardo, Murcia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Simonelli-Muñoz', 'Affiliation': 'E.U. Human and Dietetic Nutrition, San Antonio Catholic University, Campus Los Jerónimos, s/n, 30107, Murcia, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Campillo-Cano', 'Affiliation': 'E.U. Human and Dietetic Nutrition, San Antonio Catholic University, Campus Los Jerónimos, s/n, 30107, Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Auñón', 'Affiliation': 'Department of Food Technology and Nutrition, Molecular Recognition and Encapsulation Group (REM), San Antonio Catholic University, Campus Los Jerónimos, s/n, 30107, Murcia, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferreres', 'Affiliation': 'Research Group on Quality, Safety, and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Edif. 25, 30100, Espinardo, Murcia, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety, and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Edif. 25, 30100, Espinardo, Murcia, Spain. angelgil@cebas.csic.es.'}]",European journal of nutrition,['10.1007/s00394-020-02295-0'] 2564,32524231,Effects of low-dose milk protein supplementation following low-to-moderate intensity exercise training on muscle mass in healthy older adults: a randomized placebo-controlled trial.,"PURPOSE The purpose of this study was to examine whether long-term ingestion of low-dose milk protein supplementation causes a greater increase in muscle mass and strength of older adults during low-to-moderate intensity exercise training intervention than isocaloric carbohydrate. METHODS In a randomized, double-blind, and placebo-controlled design, 122 healthy older adults (60-84 year) received either an acidified milk protein drink containing 10 g of milk protein (MILK; n = 61) or an isocaloric placebo drink (PLA; n = 61) daily throughout 6 months of body weight and medicine ball exercise training. Measurements before and after the intervention included body composition, physical performance and blood biochemistry. RESULTS Lean body mass significantly increased in the MILK group (+ 0.54 kg, p < 0.001), but did not change in the PLA group (- 0.10 kg, p = 0.534). The increases in the MILK group were significantly greater than in the PLA group (p = 0.004). Fat mass (- 0.77 kg) and plasma uric acid levels (- 0.3 mg/dL) significantly decreased only in the MILK group (p < 0.001), with a significant group difference (p = 0.002 and p < 0.001, respectively). Most of the physical performance tests significantly improved in both groups, but no group differences were found. CONCLUSION We conclude that low-dose milk protein supplementation (10 g of protein/day) combined with low-to-moderate intensity exercise training is associated with increased muscle mass, but not improved physical performance compared to carbohydrate combined with exercise in healthy older adults. This study was registered in the UMIN Clinical Trials Registry (UMIN000032189).",2020,"RESULTS Lean body mass significantly increased in the MILK group (+ 0.54 kg, p < 0.001), but did not change in the PLA group (- 0.10 kg, p = 0.534).","['older adults during low-to-moderate', 'healthy older adults', '122 healthy older adults (60-84\xa0year']","['intensity exercise training intervention', 'carbohydrate combined with exercise', 'acidified milk protein drink containing 10\xa0g of milk protein (MILK; n\u2009=\u200961) or an isocaloric placebo drink (PLA; n\u2009=\u200961) daily throughout 6\xa0months of body weight and medicine ball exercise training', 'PLA', 'low-dose milk protein supplementation', 'milk protein supplementation (10\xa0g of protein/day) combined with low-to-moderate intensity exercise training', 'intensity exercise training', 'placebo']","['Lean body mass', 'Fat mass', 'plasma uric acid levels', 'physical performance', 'muscle mass and strength', 'body composition, physical performance and blood biochemistry']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}]",122.0,0.148647,"RESULTS Lean body mass significantly increased in the MILK group (+ 0.54 kg, p < 0.001), but did not change in the PLA group (- 0.10 kg, p = 0.534).","[{'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Nakayama', 'Affiliation': 'R & D Division, Meiji Co., Ltd., 1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan. kyousuke.nakayama@meiji.com.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'R & D Division, Meiji Co., Ltd., 1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Sanbongi', 'Affiliation': 'R & D Division, Meiji Co., Ltd., 1-29-1 Nanakuni, Hachioji, Tokyo, 192-0919, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Department of Human Sciences, Obihiro University of Agriculture and Veterinary Medicine, Inada-cho, Obihiro, Hokkaido, 080-8555, Japan.'}, {'ForeName': 'Tadasu', 'Initials': 'T', 'LastName': 'Urashima', 'Affiliation': 'Department of Food Science, Obihiro University of Agriculture and Veterinary Medicine, Inada-cho, Obihiro, Hokkaido, 080-8555, Japan.'}]",European journal of nutrition,['10.1007/s00394-020-02302-4'] 2565,32524260,Developing a Sound Body: Open Trial Results of a Group Healthy Lifestyle Intervention for Young Adults with Psychosis.,"The mortality disparity for persons with schizophrenia spectrum disorders (SSDs) due to cardiovascular disease is a devastating problem. Many risk factors are present in young adults with psychosis that may be ameliorated with lifestyle interventions. Sixteen participants with SSDs enrolled in an 11-week open trial of a novel lifestyle intervention comprised of group high intensity interval training exercise and health and wellness education. The aims were to evaluate (1) feasibility and (2) impact on sedentary behavior, physical activity, nutritional knowledge, physiological outcomes, and psychological well-being at end of intervention and 11-week follow-up. Attendance rates were 70% or higher for both intervention components and participants reported increased learning about healthy eating and exercise habits. Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up. Meaningful changes were not observed in other domains.",2020,Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up.,"['Sixteen participants with SSDs enrolled in an 11-week open trial of a', 'young adults with psychosis', 'Young Adults with Psychosis', 'persons with schizophrenia spectrum disorders (SSDs']","['Group Healthy Lifestyle Intervention', 'novel lifestyle intervention comprised of group high intensity interval training exercise and health and wellness education']","['sedentary behavior, physical activity, nutritional knowledge, physiological outcomes, and psychological well-being', 'physical activity and sedentary behavior', 'sedentary behavior', 'mortality disparity', 'learning about healthy eating and exercise habits', 'Attendance rates']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",16.0,0.0175961,Moderate to large effect sizes were observed for physical activity and sedentary behavior with sustained improvements in sedentary behavior at follow-up.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. jbrowne@mgh.harvard.edu.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Vanya', 'Initials': 'V', 'LastName': 'Zvonar', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thayer', 'Affiliation': 'Department of Psychiatry, Mount Auburn Hospital, Cambridge, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Skiest', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Arntz', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kritikos', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Schnitzer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Donovan', 'Affiliation': 'Center of Excellence for Psychosocial and Systemic Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Community mental health journal,['10.1007/s10597-020-00655-y'] 2566,32524297,Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial.,"INTRODUCTION In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT; ClinicalTrials.gov number NCT01994889), tafamidis reduced the risk of all-cause mortality in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus placebo. Median overall survival was not achieved in either treatment arm (57.1 and 70.5% of patients in the placebo and tafamidis groups, respectively, survived at 30 months), limiting assessment of the potential survival benefits of treatment. METHODS A survival extrapolation analysis was conducted following technical support guidelines from the National Institute for Health and Care Excellence. Multiple models (i.e., exponential, Weibull, gamma, log-logistic, log-normal, Gompertz, generalized gamma, and generalized F) were applied to systematically fit different candidate curves to existing patient-level data from the 30-month treatment period in ATTR-ACT. The relative goodness-of-fit for each candidate curve was then tested by Akaike's and Bayesian information criteria to select a single model that was fitted to the placebo and pooled tafamidis treatment arms. RESULTS A gamma distribution was selected as best fitting model and fitted to both treatment arms. The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months). CONCLUSIONS This extrapolation of survival data from ATTR-ACT further supports the efficacy of tafamidis in patients with ATTR-CM. Owing to the limitations of this analysis, these survival estimates should be interpreted with caution; however, they are consistent with recently presented findings from a combined analysis of data from ATTR-ACT and interim data from an ongoing long-term extension study (median follow-up 36 months; ClinicalTrials.gov number NCT02791230). TRIAL REGISTRATION ClinicalTrials.gov: NCT01994889.",2020,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months). ","['patients with transthyretin amyloid cardiomyopathy (ATTR-CM) by 30% versus', 'patients with ATTR-CM', 'Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis']",['placebo'],"['Median overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis'}, {'cui': 'C2745274', 'cui_str': 'tafamidis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.496993,"The resulting estimated median overall survival was 35.16 months for placebo and 52.64 months for tafamidis (difference 17.48 months). ","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Pfizer, New York, NY, USA. Benjamin.Li@pfizer.com.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Alvir', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer, Groton, CT, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00179-2'] 2567,32524309,Measurable residual disease after the first consolidation predicts the outcomes of patients with acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy.,"We stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of ≥ 3 × 10 9 /L (high risk) or < 3 × 10 9 /L (low risk) before administering risk-adapted chemotherapy in combination with all-trans retinoic acid (ATRA). In total, 27 low-risk and 23 high-risk patients were assigned to receive induction and three courses of consolidation with ATRA and anthracycline, followed by 2-year maintenance regimen. High-risk group additionally received cytarabine during 1st consolidation and another one-shot idarubicin treatment during 3rd consolidation. We prospectively monitored measurable residual disease (MRD) after induction and each consolidation. In the low-risk and high-risk groups, 5-year disease-free survival (DFS) rates were 86.5% and 81.2% (p = 0.862), and 5-year overall survival rates were 100% and 84.8% (p = 0.062), respectively. In the MRD-negative and MRD-positive groups, 5-year DFS rates were 91.7% and 78.4% (p = 0.402) and 84.7% and 60.0% (p = 0.102) after induction and 1st consolidation, respectively. Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively. Achieving MRD-negativity after 1st consolidation, rather than after induction, was a potential predictor of relapse and DFS in patients with APL treated with ATRA + chemotherapy.",2020,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","['stratified patients with newly diagnosed acute promyelocytic leukemia (APL) according to a white blood cell (WBC) count of\u2009≥\u20093\u2009×\u200910 9', 'patients with APL treated with ATRA\u2009+\u2009chemotherapy', 'In total, 27 low-risk and 23 high-risk patients', 'patients with acute promyelocytic leukemia']","['cytarabine', 'ATRA and anthracycline']","['5-year DFS rates', 'residual disease (MRD', '5-year disease-free survival (DFS) rates', '5-year overall survival rates', 'Achieving MRD-negativity', 'Relapse rates']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",27.0,0.0290423,"Relapse rates were 8.3% and 13.3% (p = 0.570) and 9.0% and 40.0% (p = 0.076) after induction and 1st consolidation, respectively.","[{'ForeName': 'Hideho', 'Initials': 'H', 'LastName': 'Henzan', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takase', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kamimura', 'Affiliation': 'Department of Hematology, Harasanshin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Goichi', 'Initials': 'G', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Nagafuji', 'Affiliation': 'Department of Hematology, Kurume University Hospital, Kurume, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ogawa', 'Affiliation': 'Department of Hematology, Japan Community Health Care Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujisaki', 'Affiliation': 'Department of Hematology, Matsuyama Red Cross Hospital, Ehime, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yoshikane', 'Initials': 'Y', 'LastName': 'Kikushige', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Akashi', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. toshmiya@intmed1.med.kyushu-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of hematology,['10.1007/s12185-020-02911-z'] 2568,32524330,Improving primary care identification of familial breast cancer risk using proactive invitation and decision support.,"Family history of breast cancer is a key risk factor, accounting for up to 10% of cancers. We evaluated the proactive assessment of familial breast cancer (FBC) risk in primary care. Eligible women (30 to 60 years) were recruited from eight English general practices. Practices were trained on FBC risk assessment. In four randomly-assigned practices, women were invited to complete a validated, postal family history questionnaire, which practice staff inputted into decision support software to determine cancer risk. Those with increased risk were offered specialist referral. Usual care was observed in the other four practices. In intervention practices, 1127/7012 women (16.1%) returned family history questionnaires, comprising 1105 (98%) self-reported white ethnicity and 446 (39.6%) educated to University undergraduate or equivalent qualification, with 119 (10.6%) identified at increased breast cancer risk and offered referral. Sixty-seven (56%) women recommended referral were less than 50 years old. From 66 women attending specialists, 26 (39.4%) were confirmed to have high risk and recommended annual surveillance (40-60 years) and surgical prevention; while 30 (45.5%) were confirmed at moderate risk, with 19 offered annual surveillance (40-50 years). The remaining 10 (15.2%) managed in primary care. None were recommended chemoprevention. In usual care practices, only ten women consulted with concerns about breast cancer family history. This study demonstrated proactive risk assessment in primary care enables accurate identification of women, including many younger women, at increased risk of breast cancer. To improve generalisability across the population, more active methods of engagement need to be explored.Trial registration: CRUK Clinical Trials Database 11779.",2020,"From 66 women attending specialists, 26 (39.4%) were confirmed to have high risk and recommended annual surveillance (40-60 years) and surgical prevention; while 30 (45.5%) were confirmed at moderate risk, with 19 offered annual surveillance (40-50 years).","['66 women attending specialists, 26 (39.4%) were confirmed to have high risk and recommended annual surveillance (40-60\xa0years) and surgical prevention; while 30 (45.5%) were confirmed at moderate risk, with 19 offered annual surveillance (40-50\xa0years', '1127/7012 women (16.1%) returned family history questionnaires, comprising 1105 (98%) self-reported white ethnicity and 446 (39.6%) educated to University undergraduate or equivalent qualification, with 119 (10.6%) identified at increased breast cancer risk and offered referral', 'Sixty-seven (56%) women recommended referral were less than 50\xa0years old', 'ten women consulted with concerns about breast cancer family history', 'Eligible women (30 to 60\xa0years) were recruited from eight English general practices', 'familial breast cancer (FBC) risk in primary care']",['proactive invitation and decision support'],['Usual care'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0346153', 'cui_str': 'Familial cancer of breast'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0306869,"From 66 women attending specialists, 26 (39.4%) were confirmed to have high risk and recommended annual surveillance (40-60 years) and surgical prevention; while 30 (45.5%) were confirmed at moderate risk, with 19 offered annual surveillance (40-50 years).","[{'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Qureshi', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK. nadeem.qureshi@nottingham.ac.uk.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Dutton', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Weng', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sheehan', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Chorley', 'Affiliation': 'University Hospitals Derby & Burton NHS Foundation Trust, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kai', 'Affiliation': 'Division of Primary Care, NIHR School for Primary Care Research, School of Medicine, University of Nottingham, 13th Floor, Tower Building, Nottingham, NG7 2RD, UK.'}]",Familial cancer,['10.1007/s10689-020-00188-z'] 2569,32524360,Impact of a Preoperative Video-Based Educational Intervention on Postoperative Outcomes in Elective Major Abdominal Surgery: a Randomized Controlled Trial.,,2020,,['Elective Major Abdominal Surgery'],['Preoperative Video-Based Educational Intervention'],['Postoperative Outcomes'],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.142779,,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campagna', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Clari', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy. marco.clari@unito.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delfino', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rolfo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04667-7'] 2570,32524424,High efavirenz levels but not neurofilament light plasma levels are associated with poor neurocognitive functioning in asymptomatic HIV patients.,"The aim of this study is to assess the effect of efavirenz exposure on neurocognitive functioning and investigate plasma neurofilament light (Nfl) as a biomarker for neurocognitive damage. Sub-analysis of the ESCAPE-study, a randomised controlled trial where virologically suppressed, cognitively asymptomatic HIV patients were randomised (2:1) to switch to rilpivirine or continue on efavirenz. At baseline and week 12, patients underwent an extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels were measured. Subgroups of elevated (≥ 4.0 mg/L) and therapeutic (0.74 to< 4.0 mg/L) baseline efavirenz concentration were made. Differences between these groups in baseline NPA Z-scores and in delta scores after efavirenz discontinuation were assessed. Nfl level was measured using an ELISA analysis using single molecule array (Simoa) technology. Correlation of plasma NFL with NPA Z-scores was evaluated using a linear mixed model. The elevated group consisted of 6 patients and the therapeutic group of 48. At baseline, the elevated group showed lower composite Z-scores (median - 1.03; IQR 0.87 versus 0.27; 0.79. p 0.02). This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01). In the switch group, the elevated group improved more on composite scores after discontinuing efavirenz (mean 0.58; SD 0.32 versus 0.22; 0.54, p 0.15). No association between plasma Nfl and composite Z-score was found. High efavirenz exposure is associated with worse cognitive functioning compared with patients with therapeutic concentrations. Plasma Nfl is not a suitable biomarker to measure cognitive damage in this group.",2020,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","['cognitively asymptomatic HIV patients', 'asymptomatic HIV patients']","['efavirenz', 'rilpivirine or continue on efavirenz']","['plasma Nfl and composite Z-score', 'subdomains verbal', 'executive functioning', 'composite scores', 'cognitive functioning', 'extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels', 'lower composite Z-scores', 'plasma NFL with NPA Z-scores']","[{'cui': 'C0343751', 'cui_str': 'Asymptomatic human immunodeficiency virus infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",6.0,0.0736464,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Hakkers', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands. c.s.hakkers@umcutrecht.nl.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hermans', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Division of Laboratory and Pharmacy, Clinical Pharmacy, University Medical Center (UMC) Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge M W', 'Initials': 'IMW', 'LastName': 'Verberk', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Joop E', 'Initials': 'JE', 'LastName': 'Arends', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",Journal of neurovirology,['10.1007/s13365-020-00860-1'] 2571,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers. METHODS A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study. RESULTS Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups. CONCLUSIONS Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT02629289 (C1221001); NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x'] 2572,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients. METHODS Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed. RESULTS Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively. CONCLUSION Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x'] 2573,32524511,A novel approach to medicines optimisation post-discharge from hospital: pharmacist-led medicines optimisation clinic.,"Background There is a major drive within healthcare to reduce patient readmissions, from patient care and cost perspectives. Pharmacist-led innovations have been demonstrated to enhance patient outcomes. Objective To assess the impact of a post-discharge, pharmacist-led medicines optimisation clinic on readmission parameters. Assessment of the economic, clinical and humanistic outcomes were considered. Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland. Method Randomised, controlled trial. Blinded random sequence generation; a closed envelope-based system, with block randomisation. Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic. Analysis was carried out for intention-to-treat and per-protocol perspectives. Main Outcome Measure 30-day readmission rate. Results Readmission rate reduction at 30 days was 9.6% (P = 0.42) and the reduction in multiple readmissions over 180-days was 29.1% (P = 0.003) for the intention-to-treat group (n = 31) compared to the control group (n = 31). Incidence rate ratio for control patients for emergency department visits was 1.65 (95% CI 1.05-2.57, P = 0.029) compared with the intention-to-treat group. For unplanned GP consultations the equivalent incident rate ratio was 2.00 (95% CI 1.18-3.58, P = 0.02). Benefit to cost ratio in the intention-to-treat and per-protocol groups was 20.72 and 21.85 respectively. Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points. A positive impact was also demonstrated in relation to patient beliefs about their medicines and medication adherence. Conclusion A pharmacist-led post-discharge medicines optimisation clinic was beneficial from a patient care and cost perspective.",2020,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","['Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic', 'Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland']",[],"['Readmission rate reduction', 'Patient Health Related Quality of Life', 'multiple readmissions', 'Incidence rate ratio', '30-day readmission rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730261', 'cui_str': 'Attending clinic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.208605,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","[{'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Odeh', 'Affiliation': 'Pharmacy Management and Pharmaceutical Care Innovation Centre, Hashemite University, 13133 Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scullin', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hogg', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Fleming', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Scott', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'McElnay', 'Affiliation': ""Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK. j.mcelnay@qub.ac.uk.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01059-4'] 2574,32524512,Cost-effectiveness of atezolizumab plus chemotherapy for advanced non-small-cell lung cancer.,"Background Adding atezolizumab to carboplatin/nab-paclitaxel improved progression-free survival and overall survival in patients with advanced non-squamous non-small-cell lung cancer. However, estimating the economy of atezolizumab/carboplatin/nab-paclitaxel is urgent on account of the high cost of atezolizumab. Objective This study aimed to evaluate the cost-effectiveness of atezolizumab plus carboplatin/nab- paclitaxel for untreated advanced non-squamous non-small-cell lung cancer from the United States payer perspective. Setting This study was based on randomized clinical trial data from the IMpower130 (NCT02367781) published in Lancet Oncology (May 2019). Method A Markov model was constructed to estimate the health expenditure on atezolizumab in combination with carboplatin/nab-paclitaxel for advanced non-small-cell lung cancer treatment. Drug costs were collected from Red Book Wholesale Acquisition Cost, and health state utility values were obtained from the literature. Uncertainty was evaluated via one-way and probabilistic sensitivity analyses. Main outcome measure The main outcomes were cost, life years, quality-adjusted life years, and incremental cost-effectiveness ratio. Results Over a 10-year horizon, atezolizumab/carboplatin/nab-paclitaxel treatment was associated with an expected 1.76 life years and 0.99 quality-adjusted life years compared to the 1.21 life years and 0.67 quality-adjusted life years for carboplatin/nab-paclitaxel alone. Compared to carboplatin/nab-paclitaxel, atezolizumab/carboplatin/nab-paclitaxel produced an incremental cost of $105,617. The resultant incremental cost-effectiveness ratio was $333,199 per quality-adjusted life year, which exceeded the willingness-to-pay threshold of $180,000 per quality-adjusted life year. The price of atezolizumab and utility values were the parameters that greatly impacted the incremental cost-effectiveness ratio. Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year. However, reducing atezolizumab acquisition cost by 43.4% could make atezolizumab/carboplatin/nab-paclitaxel more cost-effective than carboplatin/nab-paclitaxel. Conclusion Adding atezolizumab to carboplatin/nab-paclitaxel was not cost-effective for advanced non-squamous non-small-cell lung cancer in the base-case scenario. Decreasing atezolizumab acquisition cost might enhance the cost-effectiveness.",2020,"Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year.","['patients with advanced non-squamous non-small-cell lung cancer', 'advanced non-small-cell lung cancer', 'untreated advanced non-squamous non-small-cell lung cancer from the United States payer perspective']","['atezolizumab plus chemotherapy', 'atezolizumab to carboplatin/nab-paclitaxel', 'atezolizumab/carboplatin/nab-paclitaxel', 'carboplatin/nab-paclitaxel', 'atezolizumab plus carboplatin/nab- paclitaxel', 'atezolizumab in combination with carboplatin/nab-paclitaxel', 'carboplatin/nab-paclitaxel, atezolizumab/carboplatin/nab-paclitaxel', 'Carboplatin/nab-paclitaxel']","['atezolizumab acquisition cost', 'cost, life years, quality-adjusted life years, and incremental cost-effectiveness ratio', 'Red Book Wholesale Acquisition Cost, and health state utility values', 'incremental cost-effectiveness ratio', 'Drug costs', 'cost-effectiveness', 'progression-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0725535,"Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year.","[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Lixian', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'College of Pharmacy, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Zeng', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Rao', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Pinfang', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China. 2363869908@qq.com.""}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China. wxh001@fjmu.edu.cn.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01076-3'] 2575,32524538,Upper extremity rehabilitation using video games in cerebral palsy: a randomized clinical trial.,"INTRODUCTION The aim of the present study was to compare the effects of neurodevelopmental therapy (NDT)-based upper extremity rehabilitation and video game-based therapy (VGBT) using Nintendo ® wii and leap motion controller (LMC) games on upper extremity function in patients with cerebral palsy (CP). The 30 patients included in the present study were randomized to two groups: VGBT group (VGBT using Nintendo® Wii and LMC games) and control group (NDT-based upper extremity rehabilitation). Both groups trained 3 days a week for 8 weeks. Manual dexterity was evaluated using the ""Minnesota Manual Dexterity Test (MMDT)"", functional ability using the ""Childhood Health Assessment Questionnaire (CHAQ)"" and the ""Duruoz Hand Index (DEI)"" and grip and pinch strengths using a dynamometer. Following treatment, significant changes were found, MMDT, grip and pinch strength, CHAQ, and DHI scores in both groups (p < 0.05); however, VGBT group was statistically superior to group II with respect to changes in MMDT (p < 0.05). VGBT using Nintendo ® Wii and LMC games had slightly superior effects on manual dexterity in patients with CP while compared with NDT-based upper extremity rehabilitation. Futhermore, the effects of both treatment programs on grip strengths and functional ability were similar beneficial.",2020,"Following treatment, significant changes were found, MMDT, grip and pinch strength, CHAQ, and DHI scores in both groups (p < 0.05); however, VGBT group was statistically superior to group II with respect to changes in MMDT (p < 0.05).","['patients with cerebral palsy (CP', 'cerebral palsy', 'patients with CP while compared with NDT-based upper extremity rehabilitation', '30 patients included in the present study']","['neurodevelopmental therapy (NDT)-based upper extremity rehabilitation and video game-based therapy (VGBT) using Nintendo ® wii and leap motion controller (LMC) games', 'VGBT using Nintendo ® Wii and LMC games', 'VGBT', 'Upper extremity rehabilitation using video games', 'VGBT group (VGBT using Nintendo® Wii and LMC games) and control group (NDT-based upper extremity rehabilitation']","['Minnesota Manual Dexterity Test (MMDT)"", functional ability using the ""Childhood Health Assessment Questionnaire (CHAQ)"" and the ""Duruoz Hand Index (DEI)"" and grip and pinch strengths', 'manual dexterity', 'MMDT, grip and pinch strength, CHAQ, and DHI scores', 'grip strengths and functional ability', 'Manual dexterity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C2732494', 'cui_str': 'Childhood health assessment questionnaire'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0527811', 'cui_str': 'bakumondo-to'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",30.0,0.0243632,"Following treatment, significant changes were found, MMDT, grip and pinch strength, CHAQ, and DHI scores in both groups (p < 0.05); however, VGBT group was statistically superior to group II with respect to changes in MMDT (p < 0.05).","[{'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Avcil', 'Affiliation': 'Institute of Health Sciences, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Department of Ergotherapy, Faculty of Health Sciences, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Istanbul, Turkey. saimenilayarman@istanbul.edu.tr.'}, {'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01400-8'] 2576,32524605,An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: a stepped-wedge cluster randomized trial.,"To evaluate the impact of an intervention package on maternal and newborn health indicators. A randomized stepped-wedge non-blind trial was conducted across six subdistricts within two districts in Guatemala from January 2014 to January 2017. Data on outcomes were collected on all deliveries in all 33 health centers. The intervention package included distribution of promotional materials encouraging health center delivery; education for traditional birth attendants about the importance of health center delivery; and provider capacity building using simulation training. Main outcomes were number of health center deliveries, maternal morbidity, and perinatal morbidity and mortality. Overall, there were 24 412 deliveries. Health center deliveries per 1000 live births showed an overall increase, although after adjustment for secular trends and clustering, the relative risk for the treatment effect was not statistically significant (aRR, 1.04; 95% confidence interval [CI], 0.97-1.11, P=0.242). Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease. The present study represents one of the few randomized evaluations of an integrated approach to improve birth outcomes in a low-income setting.",2020,"Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.","['six subdistricts within two districts in Guatemala from January 2014 to January 2017', 'rural Guatemala']","['promotional materials encouraging health center delivery; education for traditional birth attendants about the importance of health center delivery; and provider capacity building using simulation training', 'intervention package']","['maternal morbidity', 'perinatal morbidity', 'birth outcomes', 'number of health center deliveries, maternal morbidity, and perinatal morbidity and mortality']","[{'cui': 'C0018367', 'cui_str': 'Guatemala'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040600', 'cui_str': 'Traditional Birth Attendant'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",24412.0,0.143651,"Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Kestler', 'Affiliation': 'Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ambrosio', 'Affiliation': 'Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'University of Washington, Seattle, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Matute', 'Affiliation': 'Centro de Investigaciones en Nutrición y Salud, Guatemala City, Guatemala.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Moreno', 'Affiliation': 'USAID, Guatemala, Monitoring and Evaluation Program, Guatemala City, Guatemala.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Madriz', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'University of California, San Francisco, San Francisco, USA.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13262'] 2577,32524612,Impact of labelled glasses in a bar-laboratory setting: no effect on ad libitum alcohol consumption.,"AIMS Information provided on glass labels may be an effective method to reduce alcohol consumption. The aim of this study was to assess the impact of glass labels conveying unit information and a health warning in reducing ad libitum alcohol consumption. METHODS A cluster randomised experimental study was conducted to measure the efficacy of a labelled glass in reducing alcohol consumption in a semi-naturalistic bar-laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers. Pairs were randomised to receive two 340 ml glasses of beer or wine: labelled or plain (control). Alcohol consumption was assessed in an ad libitum drinking period and urge to drink was measured at baseline and post drinking period. Focus groups (n = 2) were conducted and thematic analysis was used to gain an insight into the acceptability and the perceived effectiveness of the glasses. RESULTS Mean unit consumption was 1.62 (SD ± 0.83) units in the labelled glass condition and 1.69 (SD ± 0.82) units in the non-labelled glass condition. There were no significant effects of the labelled glasses on ad libitum alcohol consumption (95% CI -0.25 to 0.37, p = 0.35), despite participants (85%) noticing the information. Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. CONCLUSIONS Labelled glasses did not change alcohol consumption in the current study, potentially due to ineffectiveness of this type of message in a young adult population. The information on the glasses was attended to, highlighting that glasses could be a feasible tool for providing information.",2020,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. ","['a semi-naturalistic bar-laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers']","['labelled glass', '340 ml glasses of beer or wine: labelled or plain (control', 'labelled glasses']","['alcohol consumption', 'Mean unit consumption', 'labelled glasses on ad libitum alcohol consumption', 'Alcohol consumption']","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",2.0,0.0811205,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. ","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'University of Cambridge Institute of Public Health, Forvie Site, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Abigail K', 'Initials': 'AK', 'LastName': 'Rose', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, UK.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14392'] 2578,32524803,"[Obstacles, difficulties, and facilitators in setting up a research project funded by the Hospital Program for Nursing and Paramedical Research : Lessons learned from a mental health research project]","Nursing research continues to grow and become self-sustaining. It was in this context that we received funding from the Hospital Program for Nursing and Paramedical Research for our research project on schizophrenia. Schizophrenia is a mental disorder that affects 1% of the general population, and is a crippling disease both cognitively and socially. Cognitive remediation and therapeutic education are nursing practices deemed suitable for the psychosocial rehabilitation of schizophrenia patients. We hypothesized that a therapeutic education program placed upstream of cognitive remediation would have beneficial effects. We planned to include eighty patients aged eighteen to sixty, randomized into two groups, one combining cognitive remediation and therapeutic education, the second using just cognitive remediation. Each patient was assessed using a range of neuropsychological scales. Due to difficulties encountered in including and following up with participants, our statistical results could not be used. We therefore turned our focus to the factors that facilitate and hinder the setting up of a nursing research project. We organized these factors into three areas : those related to the nurse ; those related to the care facility and the organization ; and those related to the research. The results were consistent with the literature and show how important it is to encourage nurses to be more involved in a scientific approach.",2020,The results were consistent with the literature and show how important it is to encourage nurses to be more involved in a scientific approach.,"['schizophrenia patients', 'eighty patients aged eighteen to sixty']",[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715206', 'cui_str': '18'}]",[],[],80.0,0.0143253,The results were consistent with the literature and show how important it is to encourage nurses to be more involved in a scientific approach.,"[{'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Mastracci', 'Affiliation': ''}, {'ForeName': 'Bilitys', 'Initials': 'B', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Serna', 'Affiliation': ''}, {'ForeName': 'Pierrette', 'Initials': 'P', 'LastName': 'Estingoy', 'Affiliation': ''}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Perrin-Niquet', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bagur', 'Affiliation': ''}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bechet', 'Affiliation': ''}]",Recherche en soins infirmiers,['10.3917/rsi.140.0069'] 2579,32524827,An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study.,"Chronic pain and heavy drinking are common comorbid conditions among people living with HIV/AIDS (PLWHA). An integrated approach to address these co-occurring conditions in a manner that facilitates treatment utilization would represent an important advance in HIV-care. This study examined the acceptability and feasibility of a tailored, videoconferencing intervention to reduce chronic pain and heavy drinking among PLWHA. Participants in HIV-care (n = 8) completed baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions. Acceptability and feasibility were assessed with patient satisfaction ratings and interview responses 8 weeks following baseline along with videoconferencing use during the intervention period. Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format. All participants successfully enabled videoconferencing on their own smartphones and completed a median number of 4.5 (out of 6) video-sessions. Changes in heavy drinking and pain provided additional support for the potential utility of this approach. Results suggest that this videoconferencing intervention is an acceptable and feasible method of addressing chronic pain and heavy drinking among PLWHA. Findings provide the basis for future work to examine the efficacy of this approach in a Stage 1b trial.",2020,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","['patients in HIV-care', 'Participants in HIV-care (n\u2009=\u20098) completed', 'people living with HIV/AIDS (PLWHA']","['integrated videoconferencing intervention', 'baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions', 'videoconferencing intervention']","['Acceptability and feasibility', 'chronic pain and heavy drinking', 'Chronic pain and heavy drinking', 'Treatment satisfaction and comprehensibility ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0421099,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","[{'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maya P L', 'Initials': 'MPL', 'LastName': 'Kratzer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Otis', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1776825'] 2580,32524850,Effects of a brief multimodal online intervention on the intention to conduct sun protective behaviours through targeting illness representations about skin cancer: a randomized controlled trial.,"Objective: The incidence of skin cancer can be reduced by increasing sun protective behaviours. Based on the Common-Sense Model and the Intervention Mapping approach, a brief intervention targeting illness representations about skin cancer to increase the intention to conduct sun protective behaviours was developed and evaluated regarding its effectiveness. Design: A randomized pre-post control group design with 509 healthy participants (69% women, mean age 39 years). Main outcome measures: Changes in illness representations about skin cancer (emotional representations, illness coherence, and prevention control) and the intention to conduct sun protective behaviours, i.e. UV protection and sun avoidance. Results: ANCOVAs showed that the intervention increased illness coherence and perceived prevention control as well as the intention to conduct sun protective behaviours. Mediation analyses revealed that the increase in illness coherence and/or perceived prevention control partially mediated the effect of the intervention on the increase of the intention to use UV protection (indirect effects: .02*, .06*) and to avoid sun exposure (indirect effects: .01 ns, .04*). Conclusion: The intervention was successful in changing illness representations and thereby increasing the intention to conduct sun protective behaviours. The findings provide evidence for the usefulness of the Common-Sense Model in the context of illness prevention.",2020,Mediation analyses revealed that the increase in illness coherence and/or perceived prevention control partially mediated the effect of the intervention on the increase of the intention to use UV protection (indirect effects: .02,"['skin cancer', '509 healthy participants (69% women, mean age 39\u2009years']",['multimodal online intervention'],"['illness coherence', 'illness coherence and perceived prevention control', 'incidence of skin cancer', 'illness representations about skin cancer (emotional representations, illness coherence, and prevention control) and the intention to conduct sun protective behaviours, i.e. UV protection and sun avoidance']","[{'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]",509.0,0.129381,Mediation analyses revealed that the increase in illness coherence and/or perceived prevention control partially mediated the effect of the intervention on the increase of the intention to use UV protection (indirect effects: .02,"[{'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Vollmann', 'Affiliation': 'Department of Socio-Medical Sciences, Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, University of Hagen, Hagen, Germany.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Salewski', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, University of Hagen, Hagen, Germany.'}]",Psychology & health,['10.1080/08870446.2020.1775831'] 2581,32524862,Effect of clarithromycin pre-treatment on the pharmacokinetics of metoclopramide after their simultaneous oral intake.,"OBJECTIVE The objective of this study was to assess the influence of enzyme suppression on the values of various pharmacokinetic factors of orally-administered metoclopramide. METHOD This study was conducted in two phases and a 4-week duration was adopted for drug wash out. This randomized study involved twelve healthy human volunteers who received a single oral dose of metoclopramide 20 mg. After the washout period, volunteers received clarithromycin 500 mg two times per day for consecutive five days. On test day (fifth day), a single oral dose of metoclopramide 20 mg was also given to the volunteers and collection of blood samples was conducted at pre-decided time points. Various pharmacokinetic parameters such as C max, T max , and AUC 0-∞ of metoclopramide were determined analyzing the blood samples using a validated HPLC-UV method. RESULTS Clarithromycin increased the mean values of C max , AUC 0-∞ and T 1/2 of metoclopramide by 46%, 78.6%, and 9.8%, respectively. CONCLUSION Clarithromycin noticeably increased the concentration of plasma metoclopramide. This study's results provide in vivo confirmation of the CYP3A4 involvement in metoclopramide metabolism, in addition to CYP2D6. Therefore, metoclopramide pharmacokinetics may be clinically affected by clarithromycin and other potent enzyme inhibitors.",2020,"RESULTS Clarithromycin increased the mean values of C max , AUC 0-∞ and T 1/2 of metoclopramide by 46%, 78.6%, and 9.8%, respectively. ",['twelve healthy human volunteers who received a single oral dose of'],"['metoclopramide 20 mg', 'metoclopramide', 'clarithromycin', 'Clarithromycin']","['mean values of C max , AUC 0-∞ and T 1/2 of metoclopramide', 'concentration of plasma metoclopramide', 'C max, T max , and AUC 0-∞ of metoclopramide']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",12.0,0.034377,"RESULTS Clarithromycin increased the mean values of C max , AUC 0-∞ and T 1/2 of metoclopramide by 46%, 78.6%, and 9.8%, respectively. ","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Syed Nisar Hussain', 'Initials': 'SNH', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Zelal Jaber', 'Initials': 'ZJ', 'LastName': 'Kharaba', 'Affiliation': 'Department of Clinical Sciences, College of Pharmacy, Al-Ain University of Science and Technology , Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Manal Ali', 'Initials': 'MA', 'LastName': 'Buabeid', 'Affiliation': 'Department of Clinical Sciences, Ajman University , Ajman 346, United Arab Emirates.'}, {'ForeName': 'Yaseen Abd', 'Initials': 'YA', 'LastName': 'Alfoteih', 'Affiliation': 'City University College of Ajman , Ajman 18484, United Arab Emirates.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS Institute of Information Technology , Lahore 54000, Pakistan.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1779699'] 2582,32524888,Elective replacement of peripheral intravenous cannulas in neonates.,"BACKGROUND Newborns admitted to neonatal units often require vascular access. Peripheral intravenous cannulas allow essential medication, fluids, and/or parenteral nutrition to be delivered. Peripheral intravenous cannulas are often associated with complications, such as extravasation, infiltration, phlebitis, leakage, spontaneous dislodgement, and catheter-associated blood stream infection. METHODS A secondary analysis of a randomized controlled trial evaluating standard replacement versus elective replacement (72-96 h) of peripheral intravenous cannula was conducted in a tertiary-level neonatal unit in Melbourne, Australia. The main outcome of this analysis was to assess the risk of combined adverse events associated with elective replacement of peripheral intravenous cannula. A cost analysis of the intervention was also conducted. RESULTS Combined adverse outcomes noted per infant were 48 (87.27%) in the standard replacement group versus 44 (75.86%) in the elective replacement group (RR 0.87; 95% CI 0.71-1.04, p = 0.15). In terms of combined adverse outcome per 1000 intravenous hours, there was a significant risk ratio of 0.81 in the elective group compared with the standard group (95% CI 0.65-0.98, p = 0.04). Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events. There were also significantly higher costs involved with elective replacement. CONCLUSION Elective replacement of peripheral intravenous cannulas was not shown to reduce the risk of combined adverse events. Elective peripheral intravenous cannula replacement also incurred a higher cost.",2020,"Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events.","['neonates', 'Newborns admitted to neonatal units often require vascular access', '72-96 h) of peripheral intravenous cannula was conducted in a tertiary-level neonatal unit in Melbourne, Australia']","['Elective replacement of peripheral intravenous cannulas', 'Elective peripheral intravenous cannula replacement', 'standard replacement versus elective replacement']","['total number of re-sites', 'elective replacement', 'risk of combined adverse events', 'risk of combined adverse events associated with elective replacement of peripheral intravenous cannula', 'risk ratio']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.27204,"Gestation (adjusted odds ratio (AOR) 0.58; 95% CI 0.35-0.96, p = 0.03), male gender (AOR 4.65; 95% CI 1.07-20.28, p = 0.04), elective replacement (AOR 0.12; 95% CI 0.03-0.68, p = 0.01), and the total number of re-sites (AOR 27.84; 95% CI 4.61-168.18, p < 0.001) were significant risk factors associated with adverse events.","[{'ForeName': 'Darien Daojuin', 'Initials': 'DD', 'LastName': 'Liew', 'Affiliation': 'Department of Paediatrics, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Li Yen', 'Initials': 'LY', 'LastName': 'Chin', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Davies-Tuck', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Paediatrics, Monash University, Melbourne, VIC, Australia.'}]",The journal of vascular access,['10.1177/1129729820927235'] 2583,32524889,Changes in hand grip strength and body weight after a dynamic exercise program and Mediterranean diet in women with rheumatoid arthritis: a randomized clinical trial.,"BACKGROUND In patients with rheumatoid arthritis (RA) exercise improves muscle strength and decreases fat mass, whereas the consumption of a Mediterranean diet (MD) also has been associated with higher grip strength. Therefore, it is important to explore the combined effects of these interventions on hand grip strength and weight in RA. OBJECTIVE To determine the combined effect of an MD and a dynamic exercise program (DEP) on hand grip strength in women with RA. METHOD In a randomized clinical trial, 106 women with RA were included and assigned to the DEP-MD, DEP and MD groups. Weight, body circumferences, Disease Activity Score-28, Health Assessment Questionnaire Disability Index [HAQ-DI], and hand grip strength were measured at baseline and 24 weeks after the interventions. RESULTS After 24 weeks, hand grip strength showed a significant increase in the DEP group (median 2 kg) compared with DEP-MD (median 0.5 kg) and MD (median -0.5 kg) groups ( p = 0.03). In the MD group weight and waist circumference showed a significant decrease (-2.2 kg and -4.3 cm) compared with DEP-MD (0.85 kg and 1.9 cm) and DEP (0.35 kg and 0.5 cm) groups ( p < 0.01). Finally, a significant decrease was observed in the HAQ-DI after treatment in the DEP-MD group of -0.5 and the DEP group of -0.25 compared with the MD group with no change ( p = 0.03). CONCLUSION In women with RA, in addition to pharmacological treatment, DEP increases hand grip strength and an MD decreases weight and waist circumferences, while the combination of DEP and MD improves disability.",2020,"After 24 weeks, hand grip strength showed a significant increase in the DEP group (median 2 kg) compared with DEP-MD (median 0.5 kg) and MD (median -0.5 kg) groups ( p = 0.03).","['106 women with RA', 'patients with rheumatoid arthritis (RA', 'women with rheumatoid arthritis', 'women with RA']","['dynamic exercise program and Mediterranean diet', 'MD and a dynamic exercise program (DEP']","['Weight, body circumferences, Disease Activity Score-28, Health Assessment Questionnaire Disability Index [HAQ-DI], and hand grip strength', 'HAQ-DI', 'DEP-MD', 'muscle strength and decreases fat mass', 'weight and waist circumference', 'disability', 'hand grip strength', 'grip strength and an MD decreases weight and waist circumferences', 'hand grip strength and body weight', 'DEP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",106.0,0.0966444,"After 24 weeks, hand grip strength showed a significant increase in the DEP group (median 2 kg) compared with DEP-MD (median 0.5 kg) and MD (median -0.5 kg) groups ( p = 0.03).","[{'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pineda-Juárez', 'Affiliation': 'Research Coordination, Centro Médico Nacional 20 de Noviembre, ISSSTE , Mexico City, Mexico.'}, {'ForeName': 'Mariel', 'Initials': 'M', 'LastName': 'Lozada-Mellado', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hinojosa-Azaola', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'García-Morales', 'Affiliation': 'Physioteraphy Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Ogata-Medel', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Llorente', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alcocer-Varela', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Orea-Tejeda', 'Affiliation': 'Heart and Respiratory Failure Clinic, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas , Mexico City, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martín-Nares', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Castillo-Martínez', 'Affiliation': 'Clinical Nutrition Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1777605'] 2584,32524895,Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial.,"BACKGROUND Skilled birth attendants must be competent to provide prompt resuscitation to save newborn lives at birth. Both knowledge and skills (competence) decline with time after training but the optimal duration for refresher training among frontline-skilled birth attendants in low-resource settings is unknown. OBJECTIVES We assessed the effect of an innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention among skilled birth attendants in Northern Uganda. METHODS A total of 26 health facilities with 86 birth attendants were equally randomised to intervention and control arms. The 2nd edition of the American Association of Pediatrics Helping-Babies-Breathe curriculum was used for training and assessment. Knowledge and skills were assessed pre- and post-training, and during follow-up at 6 months. A mixed effects linear regression model for repeated measures was used to assess the short and long-term effects of the intervention on neonatal resuscitation practices while accounting for clustering. RESULTS Eighty-two (95.3%) skilled birth attendants completed follow-up at 6 months. Approximately 80% of these had no prior Helping-Babies-Breathe training and 75% reported practicing neonatal resuscitation routinely. Standard Helping-Babies-Breathe training with video-debriefing improved knowledge and skills attainment post-training [adjusted mean difference: 5.34; 95% CI: 0.82-10.78] and retention [adjusted mean difference: 2.97; 95% CI: 1.52-4.41] over 6 months post-training compared to standard training after adjusting for confounding and clustering. Factors that reduced knowledge and skills retention among birth attendants were monthly resuscitation of one neonate or more and being in service for more than 5 years. CONCLUSION Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda. However, more research is needed to justify the proposed intervention in this context.",2020,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"['A total of 26 health facilities with 86 birth attendants', 'skilled birth attendants in Northern Uganda', 'health workers in Uganda']","['innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention', 'video-debriefing to standard Helping-Babies-Breathe training']",['knowledge and skills retention'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0374356,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Odongkara', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pejovic', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Vincentina', 'Initials': 'V', 'LastName': 'Achora', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mukunya', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ndeezi', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nankabirwa', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}]",Global health action,['10.1080/16549716.2020.1743496'] 2585,32524912,Improving the Wellbeing of Female Prisoners via Psychological Skills Training: A Feasibility Study.,"Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population. The integration of positive psychological interventions in offender supervision has received recent advocacy. The aim of the current pre-post pilot study was to determine the short-term effects of group-based resilience training on mental health outcomes for female offenders and explore intervention acceptability. Offenders ( n  = 24) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities. The training was taught in nine sessions of 1.5 hr each. Baseline and follow-up measurements of mental wellbeing and psychological distress were collected and focus groups conducted to investigate participants' experiences, acceptability, and appropriateness of the training. Moderate to large effect sizes indicating significant improvements were observed for wellbeing, g  = 0.75 and distress, g  = 0.56. Training was well received by participants and staff and was delivered feasibly within the prison context. The results are encouraging, and a future well-powered study using a rigorous controlled design is warranted.",2020,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"['female offenders', 'Female Prisoners via Psychological Skills Training', 'Offenders ( n \u2009=\u200924) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities']",['group-based resilience training'],"['rates of mental disorders and lower mental wellbeing', 'mental health outcomes', 'mental wellbeing and psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0242408,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Iasiello', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'van Agteren', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X20928029'] 2586,32524934,"Examining child intake frequency, mothers' own liking and child early exposure as potential predictors of child liking for restricted foods and drinks at 5 years old.","OBJECTIVE To examine longitudinal patterns of child introduction to foods and drinks targeted for restriction by parents and associations between child intake frequency, mother's own liking, child early exposure and child liking for restricted foods and drinks at 5 years old. DESIGN The study involved secondary analyses of longitudinal data from mothers and children participating in the NOURISH randomised controlled trial. Patterns of descriptive data were examined, and a binary logistic regression model tested for prediction of child liking of a selection of restricted foods and drinks. SETTING Brisbane and Adelaide, Australia. PARTICIPANTS Two hundred and eleven mothers and their first born 5-year-old children. RESULTS The proportion of children who had tried the selected restricted foods and drinks progressively increased from 14 months to 5 years old. Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old. Child high intake frequency at 5 years old also predicted child high liking for sweet foods and drinks, but child early exposure did not predict child liking for the restricted items examined. CONCLUSIONS These results challenge the belief that limiting children's intake of foods high in sugar, fat and/or salt will increase their liking for them. Findings instead suggest that restricting children's access to such foods may be beneficial. While further research is required, mothers should be made aware that their own food preferences may inadvertently influence their child's liking for the very foods they are trying to restrict.",2020,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"['Two hundred and eleven mothers and their first born 5-year-old children', 'Brisbane and Adelaide, Australia', 'mothers and children participating in the NOURISH randomised controlled trial']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],211.0,0.0156282,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Kimberley M', 'Initials': 'KM', 'LastName': 'Mallan', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Public health nutrition,['10.1017/S1368980020000312'] 2587,32524948,Rapid Reduction of Campylobacter Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three Campylobacter species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in Campylobacter species after azithromycin treatment, generating the hypothesis that a decrease in Campylobacter may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three Campylobacter species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three Campylobacter species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940'] 2588,32514830,Handheld robotic needle holder training: slower but better.,"BACKGROUND Handheld robotic laparoscopic instruments fill the gap between robotic and conventional instruments, combining the advantages of degrees of freedom and low price. The difficulty and value in learning these new instruments require detailed investigation. METHODS Forty novice surgeons with no laparoscopic experience were randomly assigned to two groups: conventional instrument group (Group Conv) and robotic instrument group (Group Rob). The same training protocol was used in both groups: after viewing a standard operation film, laparoscopic suture training was administered using the corresponding instruments. After each training period, surgeons were tested using a force-sensing test platform. Maximum force (MF) and impulse (IMP) of operators through each ring were recorded. Learning curves based on MF and IMP for both instruments were compared. Institutional review board approval is not needed for this study. RESULTS MF and IMP of both groups decreased with increased training time; the learning curve of Group Conv decreased faster than that of Group Rob. When training time reached 13 h, the MF of Group Rob was significantly lower than that of Group Conv (P < 0.05), while IMP showed no significant difference between the two groups. CONCLUSIONS Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders. Group Rob took longer to reach a plateau, but subsequently had lower suture tension than did Group Conv. MF is more sensitive than IMP for measuring performance progress.",2020,"CONCLUSIONS Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders.",['Forty novice surgeons with no laparoscopic experience'],"['laparoscopic suture training', 'conventional instrument group (Group Conv) and robotic instrument group (Group Rob', 'Handheld robotic needle holder training']","['MF of Group Rob', 'suture tension', 'training time; the learning curve', 'Maximum force (MF) and impulse (IMP']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181952', 'cui_str': 'Needle holder'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}]",,0.0168976,"CONCLUSIONS Effective training reduces operator MF and IMP, possibly decreasing damage to tissues with both conventional and handheld robotic needle holders.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Robotics and System, Harbin Institute of Technology, No. 92, Xidazhi Street, Nangang District, Harbin, 150000, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'XiaoJia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China.'}, {'ForeName': 'Zhijiang', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Robotics and System, Harbin Institute of Technology, No. 92, Xidazhi Street, Nangang District, Harbin, 150000, China. Duzj01@hit.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, ZhongNan Hospital, Wuhan University, No. 169 Donghu Road, Wuhan, 430071, Hubei, China. jesuisking198411@hotmail.com.'}]",Surgical endoscopy,['10.1007/s00464-020-07550-3'] 2589,32514990,Effect of water composition and timing of ingestion on urinary lithogenic profile in healthy volunteers: a randomized crossover trial.,"Kidney stone disease is a common condition with a high recurrence rate and elevated costs. Despite the well-known positive effects of high fluid intake, there are little data about the roles of water composition and timing of ingestion during the day. This study examines the effect of two different waters [calcium-bicarbonate water (CBW) and oligomineral water (OW)] consumed at different times during the day on urine composition in a group of healthy volunteers. In a cross-over randomized trial, 12 healthy volunteers were assigned to a different sequence of four combined interventions (1 L of water consumed during fasting and 1 L of water consumed with meals): CBW/OW; OW/CBW; CBW/CBW; OW/OW. Participants were instructed to follow the same diet and to avoid smoking, caffeine and other beverages during the day of intervention, and to collect their urine every 2 h during the day, followed by a single overnight collection. The relative supersaturation for calcium oxalate was higher for CBW/CBW compared with all other interventions, while relative supersaturation for calcium phosphate was lower for the combination OW/CBW with meals. Urinary excretion of oxalate was lower in all interventions including CBW, while no significant differences were found for urinary calcium. Water composition and timing of ingestion have complex and interacting effects on lithogenic risk. Depending on individual characteristics, a strategy involving either OW or a mix of CBW during meals and OW outside of meals could be effective in modulating the lithogenic profile.Trial registered at clinicaltrial.gov: Protocol ID NCT03447847.",2020,"Urinary excretion of oxalate was lower in all interventions including CBW, while no significant differences were found for urinary calcium.","['12 healthy volunteers', 'healthy volunteers']","['water composition and timing of ingestion', 'combined interventions (1 L of water consumed during fasting and 1 L of water consumed with meals): CBW/OW; OW/CBW; CBW/CBW; OW/OW', 'waters [calcium-bicarbonate water (CBW) and oligomineral water (OW']","['urinary calcium', 'lithogenic risk', 'urinary lithogenic profile', 'Urinary excretion of oxalate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C4553624', 'cui_str': 'With meals'}, {'cui': 'C0054465', 'cui_str': 'calcium bicarbonate'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}]",12.0,0.052003,"Urinary excretion of oxalate was lower in all interventions including CBW, while no significant differences were found for urinary calcium.","[{'ForeName': 'Pietro Manuel', 'Initials': 'PM', 'LastName': 'Ferraro', 'Affiliation': 'U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. pietromanuel.ferraro@unicatt.it.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Baccaro', 'Affiliation': 'U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Baroni', 'Affiliation': 'U.O.C. Chimica, Biochimica e Biologia Molecolare, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': ""D'Alessandri"", 'Affiliation': 'U.O.C. Nutrizione Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Carpenito', 'Affiliation': 'BioHealth Italia, Turin, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Di Daniele', 'Affiliation': 'U.O.C. Medicina Interna, Università di Roma Tor Vergata, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Urbani', 'Affiliation': 'U.O.C. Chimica, Biochimica e Biologia Molecolare, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambaro', 'Affiliation': 'Renal Unit, Division of Nephrology and Dialysis, Department of Medicine, University of Verona, Verona, Italy.'}]",Journal of nephrology,['10.1007/s40620-020-00769-2'] 2590,32515040,"Effects of low-dose Aloe sterol supplementation on skin moisture, collagen score and objective or subjective symptoms: 12-week, double-blind, randomized controlled trial.","Daily oral intake of 40 μg Aloe sterol was shown in a double-blind clinical trial to significantly increase skin barrier function, moisture and elasticity. Ultrasonographic results also suggested that the intake of Aloe sterol increases collagen content in the dermis. Here, we evaluate the effects of a much smaller dose of Aloe sterol, approximately half that used previously, on skin functions in more detail. This is a monocentric, double-blind, randomized, placebo-controlled, supplementation study of the effects of low-dose Aloe sterol on skin transepidermal water loss, hydration, collagen score, evaluation of objective or subjective symptoms, and safety after 12 weeks of daily intake. We randomly administrated either Aloe sterol or placebo to 122 healthy volunteers. Transepidermal water loss was significantly reduced and collagen score was increased in the Aloe sterol group compared with the placebo group at week 12. In the Aloe sterol group, there was significant improvement of objective skin condition (face erythema and pruritus of inner and outer arms) at week 12 compared with week 0, but not in the placebo group. Subjectively, there was significant improvement of visual analog scale of skin acne, fingernail brittleness and constipation in the Aloe sterol group. According to subgroup analysis, although not planned before the study initiation, subjects with dry skin in the Aloe sterol group had significantly increased skin hydration values at week 12 compared with the placebo group. Our results confirmed that even low-dose Aloe sterol ingestion improves skin moisture by promoting skin barrier function and dermal collagen production, which contributes to maintenance of healthy skin.",2020,Transepidermal water loss was significantly reduced and collagen score was increased in the Aloe sterol group compared with the placebo group at week 12.,['122 healthy volunteers'],"['low-dose Aloe sterol supplementation', 'Aloe sterol ingestion', '40\xa0μg Aloe sterol', 'Aloe sterol or placebo', 'low-dose Aloe sterol', 'Aloe sterol', 'placebo']","['objective skin condition (face erythema and pruritus of inner and outer arms', 'skin moisture, collagen score and objective or subjective symptoms', 'skin barrier function, moisture and elasticity', 'skin transepidermal water loss, hydration, collagen score, evaluation of objective or subjective symptoms, and safety', 'Transepidermal water loss', 'visual analog scale of skin acne, fingernail brittleness and constipation', 'skin hydration values', 'collagen score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0222001', 'cui_str': 'Fingernails'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",122.0,0.26538,Transepidermal water loss was significantly reduced and collagen score was increased in the Aloe sterol group compared with the placebo group at week 12.,"[{'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Kaminaka', 'Affiliation': 'Department of Dermatology, Wakayama Medical University Graduate School of Medicine, Wakayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Dermatology, Wakayama Medical University Graduate School of Medicine, Wakayama, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Sakata', 'Affiliation': 'Department of Dermatology, Wakayama Medical University Graduate School of Medicine, Wakayama, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Dermatology, Wakayama Medical University Graduate School of Medicine, Wakayama, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Misawa', 'Affiliation': 'Functional Food Ingredients Department, Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd, Zama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nabeshima', 'Affiliation': 'Functional Food Ingredients Department, Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd, Zama, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Functional Food Ingredients Department, Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd, Zama, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Functional Food Ingredients Department, Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd, Zama, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Abe', 'Affiliation': 'Functional Food Ingredients Department, Food Ingredients and Technology Institute, Morinaga Milk Industry Co., Ltd, Zama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Jinnin', 'Affiliation': 'Department of Dermatology, Wakayama Medical University Graduate School of Medicine, Wakayama, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15428'] 2591,32515058,Randomized controlled trial of social cognition and interaction training compared to befriending group.,"BACKGROUND Deficits in social cognition are common in people with schizophrenia and are associated with impaired functioning. Finding effective interventions to address these deficits is a priority. Social Cognition Interaction Training (SCIT) is a psychosocial intervention that has demonstrated acceptability and feasibility in various health care settings. Larger, well-designed randomized controlled trials are needed to examine the effectiveness of this intervention. DESIGN A randomized controlled trial. METHODS One hundred and twenty adults diagnosed with schizophrenia spectrum disorder were randomized to receive SCIT (n = 61) or Befriending Therapy (BT) (n = 59). Both intervention groups were delivered weekly for 2 hr over 12 weeks. Neurocognitive assessment was completed at baseline. Participants completed assessments of social cognition, social functioning, and meta-cognition at baseline, post-intervention, and 3-month follow-up. RESULTS There were no clinically significant differences between group outcomes on any measure of social cognition or social functioning. There was a trend for both groups to improve over time but not at a level of statistical significance. CONCLUSIONS SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder. The findings are discussed in terms of potential improvements to the programme. PRACTITIONER POINTS Effective interventions for the social cognitive deficits of schizophrenia spectrum disorders are still being refined. Social Cognition Interaction Training is a promising therapy but requires further modifications to improve its effectiveness.",2020,"CONCLUSIONS SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder.","['people with schizophrenia spectrum disorder', 'One hundred and twenty adults diagnosed with schizophrenia spectrum disorder', 'people with schizophrenia']","['SCIT', 'Social Cognition Interaction Training', 'Social Cognition Interaction Training (SCIT', 'social cognition and interaction training', 'Befriending Therapy (BT']","['Neurocognitive assessment', 'social cognition, social functioning, and meta-cognition', 'social cognition', 'social cognition or social functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}]",120.0,0.0376513,"CONCLUSIONS SCIT did not show any additional benefits on measures of social cognition compared to Befriending Therapy for people with schizophrenia spectrum disorder.","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Dark', 'Affiliation': 'Metro South Addiction and Mental Health Services, Metro South Addiction and Mental Health Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Scott', 'Affiliation': 'Faculty of Medicine, Level 3 UQ Centre for Clinical Research (UQCCR), Herston, Queensland, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Queensland Centre for Mental Health Research, Clinical Support Unit, The Park-Centre for Mental Health, Archerfield, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Postgraduate Training in Psychiatry, Addiction and Mental Health Services I Metro South Health Blg 23, Garden City Office Park, Eight Mile Plains, Queensland, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Early Psychosis Service, Metro North Mental Health, Herston, Queensland, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Newman', 'Affiliation': 'St Kilda Road Clinic Community Adult Mental Health, Alfred Psychiatry, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gore-Jones', 'Affiliation': 'Metro South Addiction and Mental Health Services, Metro South Addiction and Mental Health Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Carmen C W', 'Initials': 'CCW', 'LastName': 'Lim', 'Affiliation': 'Queensland Centre for Mental Health Research, Clinical Support Unit, The Park-Centre for Mental Health, Archerfield, Queensland, Australia.'}, {'ForeName': 'Lyndall', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Pine Rivers Community Health Centre, Strathpine, Queensland, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The British journal of clinical psychology,['10.1111/bjc.12252'] 2592,32515065,The effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography during exercise in healthy males.,"KEY POINTS Diaphragm fatigue may increase the intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea, which may partially explain why diaphragm fatigue negatively affects exercise performance. We hypothesized that diaphragm fatigue would negatively affect exercise performance via increases in both the intensity and unpleasantness of dyspnoea, and that the increase in dyspnoea would be mechanistically linked to an increase in diaphragmatic EMG (EMG di ), a surrogate measure of neural respiratory drive. Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea. The change in submaximal dyspnoea unpleasantness was significantly correlated with the change in cycling performance. Pre-fatigue of the diaphragm did not increase EMG di during exercise and is therefore unrelated to the increase in either the sensory or affective dimension of exertional dyspnoea. ABSTRACT The purpose of this study was to examine the effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography (EMG di ) during cycling. Sixteen healthy males (age = 27 ± 5 yr, V ̇ O 2 max  = 45.8 ± 9.8 ml kg -1  min -1 ) completed two high-intensity, time-to-exhaustion cycling tests in randomized order: (i) inspiratory pressure threshold loading (PTL) prior to exercise to induce diaphragm fatigue (pre-DF) and (ii) no PTL (control). Diaphragm fatigue after PTL was confirmed via cervical magnetic stimulation of the phrenic nerves. Dyspnoea intensity and unpleasantness were measured throughout exercise with the 0-10 category-ratio Borg scale and following exercise using the Multidimensional Dyspnoea Profile (MDP). EMG di was continuously recorded via a multipair oesophageal electrode catheter. Time-to-exhaustion decreased with pre-DF vs. control (9.0 ± 5.5 vs. 10.7 ± 7.5 min, P = 0.023). Pre-DF increased dyspnoea intensity ratings by 0.6 ± 1.0 Borg 0-10 units at the highest equivalent submaximal exercise time (HESET) a participant could achieve in both conditions (P = 0.020). Dyspnoea unpleasantness ratings increased with pre-DF by 0.5 ± 1.0, 0.7 ± 1.2 and 0.9 ± 1.4 (all P < 0.05) Borg 0-10 units during the 2nd, 3rd and 4th minutes of exercise, respectively. There was a significant correlation between the change in breathing unpleasantness ratings at HESET and the change in time-to-exhaustion (r = 0.66, P = 0.006). The immediate perception domain, a combination of peak unpleasantness and specific dyspnoea descriptor intensity ratings, was the only component of the MDP that was significantly increased with pre-DF (4.3 ± 1.9 vs. 3.6 ± 1.8, P = 0.04). There were no significant differences in EMG di . In conclusion, diaphragm fatigue has negative effects on multiple domains of dyspnoea, which may partially explain why exercise performance decreases with it.",2020,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"['healthy males', 'Sixteen healthy males (age\xa0=\xa027\xa0±']",['i) inspiratory pressure threshold loading (PTL) prior to exercise'],"['diaphragmatic EMG (EMG di ', 'intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea', 'dyspnoea and diaphragm electromyography (EMG di ', 'submaximal dyspnoea unpleasantness', 'Diaphragm fatigue', 'Dyspnoea intensity and unpleasantness', 'Dyspnoea unpleasantness ratings', 'breathing unpleasantness ratings', 'Time-to-exhaustion', 'time-to-exhaustion', 'diaphragm fatigue (pre-DF) and (ii', 'peak unpleasantness and specific dyspnoea descriptor intensity ratings', 'intensity and unpleasantness of dyspnoea', 'dyspnoea intensity ratings']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282354', 'cui_str': 'Descriptor'}]",16.0,0.0454686,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"[{'ForeName': 'Kyle G', 'Initials': 'KG', 'LastName': 'Boyle', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Schaeffer', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}]",The Journal of physiology,['10.1113/JP279755'] 2593,32515246,Novel Insights Into the Effects of Interleukin 6 Antagonism in Non-ST-Segment-Elevation Myocardial Infarction Employing the SOMAscan Proteomics Platform.,"Background Interleukin 6 concentration is associated with myocardial injury, heart failure, and mortality after myocardial infarction. In the Norwegian tocilizumab non-ST-segment-elevation myocardial infarction trial, the first randomized trial of interleukin 6 blockade in myocardial infarction, concentration of both C-reactive protein and troponin T were reduced in the active treatment arm. In this follow-up study, an aptamer-based proteomic approach was employed to discover additional plasma proteins modulated by tocilizumab treatment to gain novel insights into the effects of this therapeutic approach. Methods and Results Plasma from percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48 hours postrandomization were randomly selected for analysis with the SOMAscan assay. Employing slow off-rate aptamers, the relative abundance of 1074 circulating proteins was measured. Proteins identified as being significantly different between groups were subsequently measured by enzyme immunoassay in the whole trial cohort (117 patients) at all time points (days 1-3 [7 time points] and 3 and 6 months). Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration. The acute-phase proteins lipopolysaccharide-binding protein, hepcidin, and insulin-like growth factor-binding protein 4 were all reduced during the hospitalization phase, as was the monocyte chemoattractant C-C motif chemokine ligand 23. Proteinase 3, released primarily from neutrophils, was significantly elevated. Conclusions Employing the SOMAscan aptamer-based proteomics platform, 5 proteins were newly identified that are modulated by interleukin 6 antagonism and may mediate the therapeutic effects of tocilizumab in non-ST-segment-elevation myocardial infarction.",2020,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","['percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48\xa0hours postrandomization', 'Non-ST-Segment-Elevation Myocardial Infarction']",['tocilizumab'],"['myocardial infarction, concentration of both C-reactive protein and troponin T']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",5.0,0.0679143,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'George', 'Affiliation': 'Department of Clinical Pharmacology University College London London United Kingdom.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Palmen', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lovering', 'Affiliation': 'Functional Gene Annotation, Preclinical and Fundamental Science Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}, {'ForeName': 'Jorgen', 'Initials': 'J', 'LastName': 'Engmann', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Centre of Molecular Inflammation Research Department of Clinical and Molecular Medicine NTNU Trondheim Norway.'}, {'ForeName': 'Aroon D', 'Initials': 'AD', 'LastName': 'Hingorani', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Institute of Clinical Medicine University of Oslo Norway.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Casas', 'Affiliation': 'Institute of Health Informatics University College London London United Kingdom.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015628'] 2594,32515255,"Correction to: Oxygen Exposure During Cardiopulmonary Resuscitation Is Associated With Cerebral Oxidative Injury in a Randomized, Blinded, Controlled, Preclinical Trial.",,2020,,[],['Oxygen Exposure During Cardiopulmonary Resuscitation'],[],[],"[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],,0.130556,,[],Journal of the American Heart Association,['10.1161/JAHA.119.014549'] 2595,32515412,Are Information Technologies Capable of Stimulating the Use of Dental Floss by Adolescents? A Cluster Randomised Clinical Trial.,"PURPOSE To analyse the effect of information technologies on improving the frequency of the use of dental floss among adolescents. MATERIALS AND METHODS A randomised, controlled clinical trial was conducted with 291 adolescents (mean age: 16.1 years) in three phases. Phase I involved the application of a questionnaire and clinical examinations using the simplified Oral Hygiene Index and gingival bleeding index. In phase II, the adolescents were randomly allocated to four groups: oral counseling (OR) and the use of an application (App) for smartphones; OR without the app; video (VD) and app; and VD without app. Messages were set through the app for 30 days. Phase III involved the second administration of the questionnaire and clinical examination. The frequency of dental floss use was evaluated in phases I and III. The groups were categorised into the use of technology (VD and/or App) and non-use of technology (OR alone). RESULTS Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001). Moreover, information technologies were associated with an improvement in the frequency of dental floss use (p < 0.033). CONCLUSION All methods were effective at improving clinical indicators. The use of information technologies can be considered an effective tool for improving dental floss use among adolescents.",2020,Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001).,"['291 adolescents (mean age: 16.1 years) in three phases', 'adolescents']","['technology (VD and/or App) and non-use of technology (OR alone', 'oral counseling (OR) and the use of an application (App) for smartphones; OR without the app; video (VD) and app; and VD without app']","['frequency of dental floss use', 'simplified Oral Hygiene Index and gingival bleeding index']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029165', 'cui_str': 'Oral Hygiene Indexes'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}]",291.0,0.0390319,Statistically significant reductions in the clinical indices were found with all educational methods (p < 0.005) and improvements were found in the use of dental floss (p < 0.001).,"[{'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': ''}, {'ForeName': 'Luciana Reichert da Silva', 'Initials': 'LRDS', 'LastName': 'Assunção', 'Affiliation': ''}, {'ForeName': 'Geisla Mary Silva', 'Initials': 'GMS', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'Fabian Calixto', 'Initials': 'FC', 'LastName': 'Fraiz', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44684'] 2596,32515413,Preoperative Mouthwash in Subjects with Different Periodontal Status: A Randomised Controlled Clinical Trial.,"PURPOSE The effects of three preoperative mouthwashes on salivary bacterial levels were evaluated and compared between subjects with differing periodontal status. MATERIALS AND METHODS Based on periodontal parameters, periodontally healthy individuals (n = 60) and those with gingivitis (n = 60) and periodontitis (n = 60) were randomly assigned to a single preoperative dose of chlorhexidine (CHX), essential oils (EO), cetylpyridinium chloride (CPC) or negative control mouthwashes. Saliva samples were collected between 8:00 and 11:00 a.m., before and after a single-dose rinse with the respective mouthwash. Total bacterial load and levels of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Streptococcus oralis were determined by qPCR. Data were statistically analysed using paired t- and Student's t-tests (p < 0.05). RESULTS CHX, EO and CPC showed greater antimicrobial efficacy than did the negative control. CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]). CHX provided greater reductions of simultaneous levels of Pg [106326.00], Td [3335841] and Tf [61557.47] in the healthy group, as did EO in the diseased groups. CPC provided the greatest reduction [3775319.36] in the periodontitis group. CONCLUSION Periodontal status influenced the antimicrobial efficacy of preoperative mouthwashes. Therefore, periodontal status should be taken into consideration by clinicians. The antimicrobial efficacy differed among the agents tested. CHX and EO showed the greatest efficacy. The recognition of periodontal condition by clinicians is mandatory to select the most effective preoperative mouthwash.",2020,CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]).,"['subjects with differing periodontal status', 'periodontally healthy individuals (n = 60) and those with gingivitis (n = 60) and periodontitis (n = 60', 'Subjects with Different Periodontal Status', 'healthy group, as did EO in the diseased groups']","['chlorhexidine (CHX), essential oils (EO), cetylpyridinium chloride (CPC) or negative control mouthwashes', 'CPC', 'CHX']","['Saliva samples', 'Tannerella forsythia, Treponema denticola and Streptococcus oralis', 'salivary bacterial levels', 'antimicrobial efficacy', 'Total bacterial load and levels of Porphyromonas gingivalis']","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0007907', 'cui_str': 'Cetylpyridinium chloride'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0318174', 'cui_str': 'Streptococcus oralis'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}]",60.0,0.027328,CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]).,"[{'ForeName': 'Priscila de Macedo', 'Initials': 'PM', 'LastName': 'Máximo', 'Affiliation': ''}, {'ForeName': 'Sheila Cavalca', 'Initials': 'SC', 'LastName': 'Cortelli', 'Affiliation': ''}, {'ForeName': 'Davi Romeiro', 'Initials': 'DR', 'LastName': 'Aquino', 'Affiliation': ''}, {'ForeName': 'Taís Browne', 'Initials': 'TB', 'LastName': 'de Miranda', 'Affiliation': ''}, {'ForeName': 'Fernando Oliveira', 'Initials': 'FO', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'José Roberto', 'Initials': 'JR', 'LastName': 'Cortelli', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44308'] 2597,32515424,Quantitative and Qualitative Evaluation of Enamel Erosion Following Air Abrasion with Bioactive Glass 45S5.,"PURPOSE To evaluate the effect of pre-treatment air abrasion of surfaces using bioactive glass 45S5 on the progression of erosion in bovine enamel induced by a common soft drink. MATERIALS AND METHODS Twelve intact bovine incisors were selected and 24 enamel samples were prepared and randomly assigned to two groups (n = 12): 1. control group, no anti-erosive treatment; 2. experimental group: samples were air abraded with bioglass 45S5 before the erosive challenge. The enamel samples were submitted to erosive cycling using a common soft drink. Enamel surface loss was evaluated using optical profilometry; surface microhardness and roughness changes were determined using Vickers method and Vertical Scanning Interferometry, respectively. In addition, SEM observations and EDS analysis were performed to detect any alterations in surface morphology and mineral content. The data were statistically analysed using one-way ANOVA and Tukey's post-hoc test at a significance level of α = 0.05. RESULTS The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05). However, neither group showed a statistically significant change in surface roughness (p > 0.05). After the treatments, changes in surface morphology and mineral content of enamel were observed. CONCLUSIONS Surface pre-treatment using air abrasion bioglass 45S5 may help prevent enamel erosion induced by excessive consumption of soft drinks. Further clinical trials are needed to confirm the effectiveness of this method and its clinical significance.",2020,"The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05).",['Twelve intact bovine incisors were selected and 24 enamel samples'],"['control group, no anti-erosive treatment; 2. experimental group: samples were air abraded with bioglass 45S5 before the erosive challenge']","['Quantitative and Qualitative Evaluation of Enamel Erosion', 'surface roughness', 'surface morphology and mineral content of enamel', 'surface microhardness', 'Enamel surface loss', 'surface loss']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1302752', 'cui_str': 'Abrasion'}, {'cui': 'C0965947', 'cui_str': 'bioactive glass 45S5'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0238772,"The experimental group exhibited less (18.7%) surface loss than did the control group (p < 0.05), while also presenting a statistically significantly smaller decrease in surface microhardness compared to the control group after erosive cycling (p < 0.05).","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Dionysopoulos', 'Affiliation': ''}, {'ForeName': 'Kosmas', 'Initials': 'K', 'LastName': 'Tolidis', 'Affiliation': ''}, {'ForeName': 'Effrosyni', 'Initials': 'E', 'LastName': 'Tsitrou', 'Affiliation': ''}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Kouros', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Naka', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a44689'] 2598,32515703,[The Effects of Preventive Counseling Followed by Remote Support Via Telephone on the Motivation to Change Lifestyle in Patients With High and Very High Cardiovascular Risk].,"Aim To evaluate effectiveness of preventive telephone counseling with a nutritional component and distance support for three months with respect of motivation for lifestyle modification in patients with high and very high cardiovascular risk (CVR).Material and methods This prospective, controlled, randomized clinical study in two parallel groups included patients with high and very high CVR (5-9 % and ≥10 % according to the SCORE scale) who had at least two criteria of metabolic syndrome. Patients were randomized to the main and control groups in a 1:1 ratio with age and gender stratification. The main group received comprehensive preventive counseling with a nutritional component and distant support via telephone once in two weeks for three months (total 6 consultations). Patients of the control group received standard counseling by a health center physician. Patients' motivation for lifestyle changes was evaluated with a questionnaire at baseline and at 6 and 12 months.Results The study included a total of 100 patients (mean age, 59.85±4.47 years, 80 % females). At baseline, 81 % of patients had high and 19% of patients had very high CVR. Patients of the study groups did not differ in major demographic and clinical characteristics. At 6 month of follow-up, the main group showed a significantly more pronounced positive changes in motivation and healthier lifestyle (50 % in the main group vs. 12% in the control group, р<0.01). At 12 months of follow-up, the number of such patients somewhat decreased to 38%. In this process, a vast majority of patients in the control group (82 %) continued theoretically considering the expediency of lifestyle modification.Conclusions Preventive counseling with nutritional component and further distance support via telephone for three months for patients with high and very high CVR provided increased motivation for healthier lifestyle and positive behavioral changes.",2020,"At 6 month of follow-up, the main group showed a significantly more pronounced positive changes in motivation and healthier lifestyle (50 % in the main group vs. 12% in the control group, р<0.01).","['patients with high and very high cardiovascular risk (CVR).Material', 'Patients', '100 patients (mean age, 59.85±4.47 years, 80\u200a% females', 'two parallel groups included patients with high and very high CVR (5-9\u200a% and ≥10\u200a% according to the SCORE scale) who had at least two criteria of metabolic syndrome']","['standard counseling by a health center physician', 'Preventive Counseling Followed by Remote Support', 'preventive telephone counseling with a nutritional component and distance support', 'comprehensive preventive counseling with a nutritional component and distant support via telephone']",['motivation and healthier lifestyle'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0443203', 'cui_str': 'Distant'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]",100.0,0.0250074,"At 6 month of follow-up, the main group showed a significantly more pronounced positive changes in motivation and healthier lifestyle (50 % in the main group vs. 12% in the control group, р<0.01).","[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Yusubova', 'Affiliation': ""Children's Center for the diagnosis and treatment N. A. Semashko Russian Federation.""}, {'ForeName': 'Yu M', 'Initials': 'YM', 'LastName': 'Yufereva', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Ausheva', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Karpova', 'Affiliation': 'National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Vygodin', 'Affiliation': 'National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia.'}]",Kardiologiia,['10.18087/cardio.2020.5.n1009'] 2599,32515738,Bioresorbable scaffolds versus everolimus-eluting metallic stents: Five years clinical outcomes of the randomised ABSORB II trial.,,2020,,[],['everolimus-eluting metallic stents'],[],[],"[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}]",[],,0.0641064,,"[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': ''}, {'ForeName': 'Àngel', 'Initials': 'À', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': ''}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rapoza', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Reith', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de Sousa Almeida', 'Affiliation': ''}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': ''}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Íñiguez-Romo', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00024'] 2600,32515740,Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial.,"BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was -3.6 (SD 6.6) in the intervention group and -3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t 91 =-0.37; P=.72, 95% CI -3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t 84 =-2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ 2 1 =6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. TRIAL REGISTRATION ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733.",2020,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"['95 participants were enrolled (intervention, n=47; control, n=48', 'patients on a waitlist to receive secondary mental health care services for depression', 'Patients Referred to Secondary Mental Health Care for Depression']","['web-based therapy guided by a coach who had a background in social work', 'leaflet of mental health resources they could access', 'guided web-based therapy', 'Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources']","['depressive symptoms', 'change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9', 'higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score', 'mean change in PHQ-9 scores']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",95.0,0.1837,The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLean', 'Affiliation': 'School of Journalism and Communication, Carleton University, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Corsi', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Litchfield', 'Affiliation': 'Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kucharski', 'Affiliation': 'Department of Psychiatry, The Ottawa Hospital, Ottawa, ON, Canada.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Genise', 'Affiliation': 'Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Selaman', 'Affiliation': 'Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Testa', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/15001'] 2601,32515747,Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study.,"BACKGROUND Persons with multiple sclerosis (MS) often experience dexterous difficulties during the performance of activities of daily living, such as fastening buttons, handling coins, or writing, therefore impacting their health-related quality of life. Mobile health (mHealth) solutions, such as tablet apps, may be used to train impaired dexterous skills. The feasibility of a tablet app-based dexterity home-based intervention in MS (TAD-MS) has not been explored yet in persons with MS. OBJECTIVE The aim of this pilot study was to evaluate the feasibility and usability of home-based dexterity training with a tablet app in both persons with MS and healthy subjects. METHODS A total of 9 persons with MS, aged 35-71 years, with an Expanded Disability Status Scale score between 2 and 7.5, performed the TAD-MS for 4 weeks, five times a week, with each training session lasting approximately 30 minutes. Participants' impaired dexterity was measured by the Nine-Hole Peg Test. A total of 10 age-matched healthy subjects also tested and rated the usability of the app. Outcome measures were the adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ). RESULTS High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8). High system usability scores (ie, mean 85.39%, SD 11.67) and overall high scores given in the CUEQ (ie, mean 8.2/10, SD 1.4) further point to high usability of the app. Neither demographic variables nor dexterity levels affected the use of the app. CONCLUSIONS This pilot study is the first to demonstrate high feasibility and usability of a new tablet app-based dexterity home-based training program among both persons with MS and healthy individuals. Whether this kind of training improves dexterity will need to be evaluated in a randomized controlled trial.",2020,"RESULTS High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","['A total of 10 age-matched healthy subjects', '9 persons with MS, aged 35-71 years', 'persons with MS', 'persons with MS and healthy subjects', 'Persons with multiple sclerosis (MS', 'persons with MS and healthy individuals', 'Multiple Sclerosis']","['new tablet app-based dexterity home-based training program', 'home-based dexterity training', 'tablet app-based dexterity home-based intervention in MS (TAD-MS', 'Home-Based Tablet App']","['Expanded Disability Status Scale score', 'High system usability scores', 'feasibility and usability', 'dexterity', 'adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0057150', 'cui_str': 'DAT protocol 1'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",9.0,0.0233663,"RESULTS High feasibility of the tablet app-based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8).","[{'ForeName': 'Judith Jantine Willemijn', 'Initials': 'JJW', 'LastName': 'van Beek', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Erwin Everardus Henri', 'Initials': 'EEH', 'LastName': 'van Wegen', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Marc Berend', 'Initials': 'MB', 'LastName': 'Rietberg', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Multiple Sclerosis Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyffeler', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bohlhalter', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Christian Philipp', 'Initials': 'CP', 'LastName': 'Kamm', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nef', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanbellingen', 'Affiliation': 'Neurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}]",JMIR mHealth and uHealth,['10.2196/18204'] 2602,32515894,"GreenLight HPS laser 120 W vs diode laser 300 W vaporization of the prostate for the treatment of benign prostatic hyperplasia in Japanese patients: A prospective, single-center, randomized clinical trial.","OBJECTIVES This study aimed to compare the safety and efficacy of laser vaporization with 532 nm GreenLight High Performance System (HPS) laser 120 W (PVP) and 980 nm diode laser 300 W (CVP) for the treatment of benign prostatic hyperplasia (BPH) in a prospective, single-center, randomized clinical trial. METHODS A total of 153 consecutive patients with symptomatic BPH were included; 79 patients were treated with PVP and 74 with CVP. Patients were assessed preoperatively and at 3, 6, and 12 months postoperatively using the International Prostate Symptom Score, quality of life index, peak urinary flow rate, and postvoid residual urine volume. All perioperative and postoperative complications were noted. RESULTS There were significant and comparable improvements in each of the outcome variables over a follow-up period of 12 months in both groups. The mean operation/vaporization duration (minutes) was comparable at 74/38 (PVP) and 76/34 (CVP), whereas the mean applied laser energy was significantly higher with CVP than with PVP at 260 vs 195 (kJ), respectively. The mean vaporization rate (mL/min) was not significantly different between the two groups (0.53 PVP vs 0.56 CVP). Immediately after surgery, the rate of recatheterization for urinary retention was significantly higher with CVP than with PVP (17.6% vs 6.8%; P < 0.05). CONCLUSIONS Both laser systems provided comparable improvement in the subjective and objective parameters with excellent hemostatic properties. Although our results suggest that both procedures are useful treatment choices, further follow-up is needed to draw definitive conclusions regarding the most ideal laser for treating patients with symptomatic BPH.",2020,There were significant and comparable improvements in each of the outcome variables over a follow-up period of 12 months in both groups.,"['benign prostatic hyperplasia (BPH', 'patients with symptomatic BPH', '153 consecutive patients with symptomatic BPH were included; 79 patients were treated with PVP and 74 with CVP', 'Japanese patients']","['GreenLight HPS laser 120\u2009W vs diode laser 300\u2009W vaporization of the prostate', 'laser vaporization with 532\u2009nm GreenLight High Performance System (HPS) laser 120\u2009W (PVP) and 980\u2009nm diode laser 300\u2009W (CVP']","['mean vaporization rate', 'All perioperative and postoperative complications', 'rate of recatheterization for urinary retention', 'safety and efficacy', 'International Prostate Symptom Score, quality of life index, peak urinary flow rate, and postvoid residual urine volume', 'mean operation/vaporization duration (minutes', 'mean applied laser energy']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]",153.0,0.0375958,There were significant and comparable improvements in each of the outcome variables over a follow-up period of 12 months in both groups.,"[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Urology, Kyushu Central Hospital, Fukuoka, Japan.'}, {'ForeName': 'Narihito', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Department of Urology, Kyushu Central Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoo H', 'Initials': 'YH', 'LastName': 'Song', 'Affiliation': 'Department of Urology, Kyushu Central Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Dejima', 'Affiliation': 'Department of Urology, Kyushu Central Hospital, Fukuoka, Japan.'}]",Lower urinary tract symptoms,['10.1111/luts.12324'] 2603,31272294,Embodying the Police: The Effects of Enclothed Cognition on Shooting Decisions.,"The theory of enclothed cognition proposes that wearing physical articles of clothing can trigger psychological processes and behavioral tendencies connected to their symbolic meaning. Furthermore, past research has found that increases in power are associated with greater approach orientation and action tendencies. In this study, we integrate these two literatures to examine how embodying the role of a police officer through wearing a uniform would affect responses on a reaction-time measure known as the Shooter Task. This first-person video game simulation requires participants to shoot or not shoot targets holding guns or objects. The task typically elicits a stereotypical pattern of responses, such that unarmed Black versus White targets are more likely to be mistakenly shot and armed Black versus White targets are more likely to be correctly shot. Based on the relationship between power and action, we hypothesized that participants who were randomly assigned to wear a police uniform would show more shooting errors, particularly false alarms, than control participants. Consistent with our hypotheses, participants in uniform were more likely to shoot unarmed targets, regardless of their race. Moreover, this pattern was partially moderated by attitudes about the police and their abuse of power. Specifically, uniformed participants who justified police use of power were more likely to shoot innocent targets than those who were wary of it. We discuss implications for police perceptions and the theory of enclothed cognition more broadly.",2019,"Specifically, uniformed participants who justified police use of power were more likely to shoot innocent targets than those who were wary of it.",[],[],[],[],[],[],,0.0167261,"Specifically, uniformed participants who justified police use of power were more likely to shoot innocent targets than those who were wary of it.","[{'ForeName': 'Saaid A', 'Initials': 'SA', 'LastName': 'Mendoza', 'Affiliation': 'Providence College, Providence, RI, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Parks-Stamm', 'Affiliation': 'University of Southern Maine, Portland, ME, USA and Grand Canyon University, Phoenix, AZ, USA.'}]",Psychological reports,['10.1177/0033294119860261'] 2604,31298923,"Complex Tears, Extrusion, and Larger Excision Are Prognostic Factors for Worse Outcomes 1 and 2 Years After Arthroscopic Partial Meniscectomy for Degenerative Meniscal Tears: A Secondary Explorative Study of the Surgically Treated Group From the Odense-Oslo Meniscectomy Versus Exercise (OMEX) Trial.","BACKGROUND Few studies have examined morphological findings from preoperative magnetic resonance imaging (MRI) and arthroscopic findings as prognostic factors for outcomes 1 and 2 years after arthroscopic partial meniscectomy (APM). PURPOSE/HYPOTHESIS The purpose was to evaluate prognostic factors of preoperative findings from MRI and arthroscopic evaluation on lower extremity performance at 1 year and patient-reported outcomes at 1 to 2 years after APM. The hypothesis was that medial compartment abnormalities would be prognostic for 1- and 2-year functional outcomes. STUDY DESIGN Cohort study; Level of evidence, 2. METHODS This secondary analysis from the OMEX (Odense-Oslo Meniscectomy Versus Exercise) trial included 40 patients treated surgically. Regression analyses with adjustments for age, sex, and body mass index explored associations between MRI findings (tear complexity and extrusion), arthroscopic findings (tear length, cartilage injury, and amount of excised meniscal tissue), and the following: lower extremity performance tests and thigh muscle strength at 1 year and the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales at 1 and 2 years. RESULTS A complex meniscal tear was a significant and clinically relevant prognostic factor for worse KOOS Symptoms subscores at 2 years (mean, 14.1 points [95% CI, 6.1-22.2]). Meniscal extrusion of at least 11%, 25%, and 20% were significant and clinically relevant prognostic factors for worse KOOS Activities of Daily Living (ADL) subscores at 1 year and worse KOOS Sports and Recreation (Sports/Rec) subscores at 1 and 2 years, respectively. Tear lengths of at least 7.0 mm, 6.7 mm, and 6.5 mm were significant and clinically relevant prognostic factors for better KOOS Symptoms subscores at 1 year and better KOOS Sports/Rec subscores at 1 and 2 years, respectively. A cartilage injury in the medial compartment was a significant and clinically relevant prognostic factor for worse KOOS ADL and Quality of Life (QoL) subscores at 2 years (mean, 10.4 and 19.4 points, respectively [95% CI, 3.4-17.4 and 7.7-31.1, respectively]). More than 20% meniscal tissue excised was a significant and clinically relevant prognostic factor for worse KOOS Pain, Symptoms, ADL, and Sports/Rec subscores at 1 and 2 years (mean, 8.9-41.5 points [95% CI, 2.2-15.5 to 21.0-62.0]) and worse KOOS QoL subscores at 2 years (mean, 25.3 points [95% CI, 13.6-37.0]). CONCLUSION Complex meniscal tears, larger extrusion, cartilage injuries, and larger meniscal excision were significant and clinically relevant prognostic factors for worse outcomes 1 and 2 years after APM. REGISTRATION NCT01002794 (ClinicalTrials.gov identifier).",2019,"A complex meniscal tear was a significant and clinically relevant prognostic factor for worse KOOS Symptoms subscores at 2 years (mean, 14.1 points [95% CI, 6.1-22.2]).","['40 patients treated surgically', 'Degenerative Meniscal Tears']","['Odense-Oslo Meniscectomy Versus Exercise (OMEX', 'preoperative magnetic resonance imaging (MRI', 'MRI and arthroscopic evaluation', 'Arthroscopic Partial Meniscectomy']","['KOOS Symptoms subscores', 'extremity performance tests and thigh muscle strength at 1 year and the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales', 'worse KOOS QoL subscores', 'KOOS ADL and Quality of Life (QoL) subscores', 'lower extremity performance', 'KOOS Pain, Symptoms, ADL, and Sports/Rec subscores', 'MRI findings (tear complexity and extrusion), arthroscopic findings (tear length, cartilage injury, and amount of excised meniscal tissue', 'KOOS Activities of Daily Living (ADL) subscores at 1 year and worse KOOS Sports and Recreation (Sports/Rec) subscores', 'Tear lengths', 'Meniscal extrusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}]","[{'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0852694', 'cui_str': 'Injury of cartilage'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",40.0,0.095433,"A complex meniscal tear was a significant and clinically relevant prognostic factor for worse KOOS Symptoms subscores at 2 years (mean, 14.1 points [95% CI, 6.1-22.2]).","[{'ForeName': 'Nina Jullum', 'Initials': 'NJ', 'LastName': 'Kise', 'Affiliation': 'Department of Orthopaedic Surgery, Martina Hansens Hospital, Sandvika, Norway.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Aga', 'Affiliation': 'Department of Orthopaedic Surgery, Martina Hansens Hospital, Sandvika, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Engebretsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ewa M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Tariq', 'Affiliation': 'Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'May Arna', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",The American journal of sports medicine,['10.1177/0363546519858602'] 2605,31449915,Decreased expression of type I (IFN-β) and type III (IFN-λ) interferons and interferon-stimulated genes in patients with chronic rhinosinusitis with and without nasal polyps.,"BACKGROUND Little is known about antiviral responses in the sinonasal mucosal tissue of patients with chronic rhinosinusitis (CRS). OBJECTIVE we investigated the presence of virus and the expression of Toll-like receptor (TLR) 3, TLR7, and interferon and interferon-stimulated genes (ISGs) in healthy mucosal tissue of control subjects and the inflammatory sinus mucosal tissue of CRS patients, and evaluated whether levels of interferons and ISGs might be affected by CRS-related cytokines and by treatment with macrolides, dexamethasone, or TLR3 and TLR7 agonists. METHODS The presence of virus in the sinonasal mucosa was evaluated with real-time PCR. The expression of interferons and ISGs in the sinonasal mucosa and in cultured epithelial cells treated with T H 1 and T H 2 cytokines, macrolides, dexamethasone, or TLR3 and TLR7 agonists were evaluated with real-time PCR and Western blotting. The expression of TLR3 and TLR7 in the sinonasal mucosa were evaluated with immunohistochemistry. RESULTS Respiratory viruses were detected in 15% of samples. Interferons and ISGs are expressed in normal mucosa, but their levels were decreased in patients with CRS. Interferon and ISG levels were upregulated in cells treated with macrolides, dexamethasone, or TLR3 agonist, but some were decreased in cytokine-treated cells. TLR3 and TLR7 levels showed no significant difference between normal and inflammatory sinus mucosal tissue. CONCLUSION These results suggest that decreased levels of interferons and ISGs in patients with CRS might contribute to impairment of the antiviral innate response in inflammatory sinonasal epithelial cells. Macrolides and glucocorticoids might provide positive effects on the treatment of CRS by upregulating interferon and ISG expression.",2019,"The expression of interferons and ISGs in the sinonasal mucosa and in cultured epithelial cells treated with T H 1 and T H 2 cytokines, macrolides, dexamethasone, or TLR3 and TLR7 agonists were evaluated with real-time PCR and Western blotting.","['patients with chronic rhinosinusitis (CRS', 'patients with chronic rhinosinusitis with and without nasal polyps', 'healthy mucosal tissue of control subjects and the inflammatory sinus mucosal tissue of CRS patients', 'patients with CRS']","['dexamethasone', 'Toll-like receptor (TLR) 3, TLR7, and interferon and interferon-stimulated genes (ISGs']","['TLR3 and TLR7 levels', 'levels of interferons and ISGs', 'Interferon and ISG levels', 'Decreased expression of type I (IFN-β) and type III (IFN-λ) interferons and interferon-stimulated genes', 'normal and inflammatory sinus mucosal tissue', 'expression of interferons and ISGs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0544791', 'cui_str': 'Inflammatory fistula'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C1313494', 'cui_str': 'TLR3 protein, human'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0544791', 'cui_str': 'Inflammatory fistula'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}]",,0.0321921,"The expression of interferons and ISGs in the sinonasal mucosa and in cultured epithelial cells treated with T H 1 and T H 2 cytokines, macrolides, dexamethasone, or TLR3 and TLR7 agonists were evaluated with real-time PCR and Western blotting.","[{'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Hwang', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Ki Jeong', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'In Hak', 'Initials': 'IH', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Hye Min', 'Initials': 'HM', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'Sang Hag', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head & Neck Surgery, College of Medicine, Korea University, Seoul, Korea. Electronic address: sanghag@kumc.or.kr.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.010'] 2606,32525416,"Effect of Hypertonic Saline during Flexible Nasopharyngeal Laryngoscopy: A Double-Blinded, Randomized, Controlled Trial.","Objectives: Flexible nasopharyngeal laryngoscopy (NPL) is a cost-effective, simple procedure that provides visualization of the nasal airways. However, it involves a number of challenges for both the clinician and the patient. Hypertonic saline nasal wash is used to prevent nasal secretion in acute/chronic sinusitis and after nasal surgery. We aimed to determine the efficacy of hypertonic saline by comparing the clinician's and patients' experiences during NPL. Methods: This prospective, double-blinded, randomized, controlled study was performed at a tertiary referral university hospital. Two hundred patients were randomly divided into hypertonic saline, lidocaine, xylometazoline, and isotonic saline groups. During NPL, the clinician's experiences in terms of the quality of the field of view and the patients' experiences in terms of pain and discomfort resulting from the 4 premedication drugs were compared. Results: The groups differed significantly in terms of the clinician's field of view, and patients' pain scores and levels of discomfort ( P  < 0.025). The field of view results were the highest in the hypertonic saline group, and the lowest in the lidocaine group. The pain scores were the lowest in the lidocaine group, whereas they were the highest in the hypertonic saline group. The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups. Conclusion: The use of hypertonic saline facilitated the NPL procedure by improving the clinician's field of view. Moreover, intranasal hypertonic saline reduced the patient's discomfort. Intranasal hypertonic saline can be a good alternative to premedication before NPL.",2020,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","['tertiary referral university hospital', 'acute/chronic sinusitis and after nasal surgery', 'Two hundred patients', 'Flexible Nasopharyngeal Laryngoscopy']","['hypertonic saline, lidocaine, xylometazoline, and isotonic saline', 'intranasal hypertonic saline', 'lidocaine', 'xylometazoline', 'Intranasal hypertonic saline', 'Flexible nasopharyngeal laryngoscopy (NPL', 'Hypertonic Saline', 'Hypertonic saline nasal', 'hypertonic saline']","[""clinician's field of view, and patients' pain scores and levels of discomfort"", 'pain scores', 'discomfort scores', ""patient's discomfort"", 'pain and discomfort', 'nasal secretion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",200.0,0.0720424,"The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups.","[{'ForeName': 'Merih', 'Initials': 'M', 'LastName': 'Onal', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Keles', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Erdur', 'Affiliation': 'Department of Otorhinolaryngology, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alatas', 'Affiliation': 'Department of Otorhinolaryngology, Konya Educational and Training Hospital, Konya, Turkey.'}, {'ForeName': 'Ozkan', 'Initials': 'O', 'LastName': 'Onal', 'Affiliation': 'Anesthesiology Institute, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1777490'] 2607,32525452,Analysis of Scapular Muscle EMG Activity During Elastic Resistance Oscillation Exercises From the Perspective of Different Arm Positions.,"BACKGROUND Little is known about the optimal exercise intensity and the effects of arm position on elastic resistance exercise. The purpose of this study was to investigate scapular muscle activity in different arm positions utilized during standing elastic resistance exercise. HYPOTHESIS Lower trapezius (LT), serratus anterior (SA), and infraspinatus (IS) muscle activity will vary across arm positions above shoulder level. Also, oscillation resistance exercise will result in increased muscle activity compared with isometric contraction. STUDY DESIGN Controlled laboratory study. LEVEL OF EVIDENCE Level 4. METHODS A total of 19 uninjured male collegiate baseball players volunteered to participate in this study. The electromyography (EMG) activity of the LT, upper trapezius (UT), middle deltoid (MD), SA, and IS muscles was determined using surface EMG in 3 arm positions: diagonal pattern 1 (D1), 120° of shoulder abduction (120), and 90° shoulder abduction with external rotation and elbow flexion (90/90) during both isometric contraction and oscillation resistance exercise. RESULTS No difference in EMG activity of the LT muscle was found between the 120 and 90/90 position. However, the 120 position increased UT and MD muscle activity significantly more than those of the 90/90 position. The D1 arm position significantly increased SA muscle activity more than the 120 and 90/90 positions while the LT muscle activity was nearly silent. CONCLUSION The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. CLINICAL RELEVANCE The use of oscillation movements under elastic loading can create high muscle activation in the LT muscle without an adverse effect of the humeral head position and scapular rotation.",2020,"The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. ",['19 uninjured male collegiate baseball players volunteered to participate in this study'],"['90° shoulder abduction with external rotation and elbow flexion (90/90) during both isometric contraction and oscillation resistance exercise', 'Elastic Resistance Oscillation Exercises']","['UT and MD muscle activity', 'Lower trapezius (LT), serratus anterior (SA), and infraspinatus (IS) muscle activity', 'scapular muscle activity', 'muscle activity', 'EMG activity of the LT muscle', 'LT muscle activity', 'SA muscle activity', 'Scapular Muscle EMG Activity', 'electromyography (EMG) activity of the LT, upper trapezius (UT), middle deltoid (MD), SA, and IS muscles']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",19.0,0.0260439,"The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. ","[{'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tsuruike', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, San José State University, San Jose, California.'}, {'ForeName': 'Todd S', 'Initials': 'TS', 'LastName': 'Ellenbecker', 'Affiliation': 'Rehab Plus Sports Therapy Scottsdale and ATP Tour, Scottsdale, Arizona.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Kanagawa Prefecture, Japan.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Lemings', 'Affiliation': 'Conte Sport Performance Therapy, Scottsdale, Arizona.'}]",Sports health,['10.1177/1941738120929305'] 2608,32525464,"Controlling Hypertension After Severe Cerebrovascular Event (CHASE): A randomized, multicenter, controlled study.","BACKGROUND The optimal blood pressure lowering target in the acute phase of severe stroke is uncertain. Our aim was to compare the efficacy and safety of individualized blood pressure lowering with standard blood pressure lowering in severe stroke. METHODS Five-hundred consecutive patients with acute severe stroke and elevated BP were recruited from 26 Chinese hospitals. Eligible patients were randomized into an individualized blood pressure lowering group (with 10-15% reduction in systolic blood pressure from admission level or standard blood pressure lowering group (with a target SBP of <200 mm Hg in acute ischemic stroke and <180 mm Hg in intracerebral hemorrhage). The primary outcome was the proportion of patients with a poor functional outcome at day 90 of enrolment. RESULTS Of 483 participants included in the analysis, 242 received individualized blood pressure lowering treatment and 241 received standard treatment. The primary outcome event was observed in 71.1% of the participants in the individualized treatment group and in 73.4% of the standard treatment group (odds ratio with individualized treatment for primary outcome, 0.75; 95% confidence interval, 0.47 to 1.19; p  = 0.222). The rates of serious adverse events in the two groups were similar (27.7% vs. 28.2%). CONCLUSIONS In patients with acute severe stoke, individualized blood pressure lowering treatment did not significantly reduce the rate of three-month death or dependence. TRIAL REGISTRATION Clinicaltrials.gov, NCT02982655. Registered in 5 December 2016, https://clinicaltrials.gov/ct2/show/NCT02982655.",2020,"The rates of serious adverse events in the two groups were similar (27.7% vs. 28.2%). ","['Eligible patients', 'Five-hundred consecutive patients with acute severe stroke and elevated BP were recruited from 26 Chinese hospitals', '483 participants included in the analysis, 242 received']","['individualized blood pressure lowering with standard blood pressure lowering', 'individualized blood pressure lowering treatment', 'individualized blood pressure lowering group (with 10-15% reduction in systolic blood pressure from admission level or standard blood pressure lowering group (with a target SBP of <200\u2009mm Hg']","['proportion of patients with a poor functional outcome', 'rate of three-month death or dependence', 'Controlling Hypertension', 'rates of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",500.0,0.301686,"The rates of serious adverse events in the two groups were similar (27.7% vs. 28.2%). ","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Fu', 'Affiliation': 'Department of Neurology, Shaanxi 215 Hospital, Xianyang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Ankang Central Hospital, Ankang, China.'}, {'ForeName': 'Changhu', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Department of Neurology, Xianyang Central Hospital, Xianyang, China.'}, {'ForeName': 'Kangjun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Hanzhong Central Hospital, Hanzhong, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, Weinan Central Hospital, Weinan, China.'}, {'ForeName': 'Dingan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Hanzhong Central Hospital, Hanzhong, China.'}, {'ForeName': 'Qiuwu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Xi'an 141 Hospital, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': ""Department of Neurology, Xi'an Gaoxin Hospital, Xi'an, China.""}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Neurology, Xi'an XD Group Hospital, Xi'an, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Shangluo Central Hospital, Shangluo, China.'}, {'ForeName': 'Xiaocheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Yulin No.2 Central Hospital, Yulin, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': ""Department of Neurology, Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Huo', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhuanhui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, 521 Hospital of NORINCO Group, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The First Affiliated Hospital of Xi'an Medical University, Xi'an, China.""}, {'ForeName': 'Chengkai', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Tongchuan People's Hospital, Tongchuan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Hongzeng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493020932784'] 2609,32525474,Thoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT.,"BACKGROUND There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However, some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective. OBJECTIVE This trial tested the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at 3 months post procedure, compared with chest drain insertion and talc slurry. DESIGN This was a multicentre, open-label, randomised controlled trial with embedded economic evaluation. Follow-up took place at 1, 3 and 6 months. SETTING This trial was set in 17 NHS hospitals in the UK. PARTICIPANTS A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included. Those adults needing a tissue diagnosis or with evidence of lung entrapment were excluded. INTERVENTIONS Allocation took place following minimisation with a random component, performed by a web-based, centralised computer system. Participants in the control arm were treated with a bedside chest drain insertion and 4 g of talc slurry. In the intervention arm, participants underwent local anaesthetic thoracoscopy with 4 g of talc poudrage. MAIN OUTCOME MEASURES The primary outcome measure was pleurodesis failure at 90 days post randomisation. Secondary outcome measures included mortality and patient-reported symptoms. A cost-utility analysis was also performed. RESULTS A total of 166 and 164 patients were allocated to poudrage and slurry, respectively. Participants were well matched at baseline. For the primary outcome, no significant difference in pleurodesis failure was observed between the treatment groups at 90 days, with rates of 36 out of 161 (22%) and 38 out of 159 (24%) noted in the poudrage and slurry groups, respectively (odds ratio 0.91, 95% confidence interval 0.54 to 1.55; p  = 0.74). No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70]. At £20,000 per quality-adjusted life-year gained, poudrage would have a 0.36 probability of being cost-effective compared with slurry. LIMITATIONS Entry criteria specified that patients must be sufficiently fit to undergo thoracoscopy, which may make the results less applicable to those patients presenting with a greater degree of frailty. Furthermore, the trial was conducted on an open-label basis, which may have influenced the results of patient-reported measures. CONCLUSIONS The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion. TRIAL REGISTRATION Current Controlled Trials ISRCTN47845793. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 26. See the NIHR Journals Library website for further project information.",2020,"No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70].","['A total of 166 and 164 patients', '17 NHS hospitals in the UK', 'A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included', 'adults needing a tissue diagnosis or with evidence of lung entrapment were excluded']","['intercostal drainage and talc slurry infusion', 'thoracoscopy and talc poudrage', 'bedside chest drain insertion and 4\u2009g of talc slurry', 'TAPPS', 'local anaesthetic thoracoscopy with 4\u2009g of talc poudrage', 'Thoracoscopy and talc poudrage']","['proportion of patients with successful pleurodesis', 'mortality and patient-reported symptoms', 'cause mortality', 'adverse events', 'mean number of nights in hospital', 'pleurodesis failure']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1285497', 'cui_str': 'Entrapment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",330.0,0.337884,"No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p  = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p  = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p  = 0.70].","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatnagar', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24260'] 2610,32525564,Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature.,"The randomized ""Testicular cancer and Aerobic- and Strength Training trial"" (TAST-trial) aimed to evaluate the effect of high-intensity interval training (HIIT) on cardiorespiratory fitness during cisplatin-based chemotherapy (CBCT) for testicular cancer (TC). Here, we report on an unexpected high number of thromboembolic (TE) events among patients randomized to the intervention arm, and on a review of the literature on TE events in TC patients undergoing CBCT. Patients aged 18-60 years with a diagnosis of metastatic germ cell TC, planned for 3-4 CBCT cycles, were randomized to a 9-12 weeks exercise intervention, or to a single lifestyle counseling session. The exercise intervention included two weekly HIIT sessions, each with 2-4 intervals of 2-4 minutes at 85-95% of peak heart rate. The study was prematurely discontinued after inclusion of 19 of the planned 94 patients, with nine patients randomized to the intervention arm and 10 to the control arm. Three patients in the intervention arm developed TE complications; two with pulmonary embolism and one with myocardial infarction. All three patients had clinical stage IIA TC. No TE complications were observed among patients in the control arm. Our observations indicate that high-intensity aerobic training during CBCT might increase the risk of TE events in TC patients, leading to premature closure of the TAST-trial.",2020,No TE complications were observed among patients in the control arm.,"['Patients aged 18-60\u2009years with a diagnosis of metastatic germ cell TC, planned for 3-4 CBCT cycles', 'testicular cancer (TC', 'testicular cancer', 'TC patients undergoing CBCT']","['cisplatin-based chemotherapy (CBCT', 'exercise intervention, or to a single lifestyle counseling session', 'high-intensity interval training (HIIT', 'cisplatin-based chemotherapy']","['TE complications', 'risk of TE events', 'thromboembolic (TE) events', 'Thromboembolic events', 'cardiorespiratory fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0017471', 'cui_str': 'Germ cell'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",9.0,0.0580454,No TE complications were observed among patients in the control arm.,"[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Thorsen', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hege S', 'Initials': 'HS', 'LastName': 'Haugnes', 'Affiliation': 'Department of Oncology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Fosså', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brydøy', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Torgrim', 'Initials': 'T', 'LastName': 'Tandstad', 'Affiliation': 'Clinic of Oncology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Wisløff', 'Affiliation': 'Institute of Clinical Medicine, University of Tromsø - The Arctic University, Tromsø, Norway.'}, {'ForeName': 'Gunhild M', 'Initials': 'GM', 'LastName': 'Gjerset', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karl-Otto', 'Initials': 'KO', 'LastName': 'Larsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Sandset', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Carola E', 'Initials': 'CE', 'LastName': 'Henriksson', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Helene F S', 'Initials': 'HFS', 'LastName': 'Negaard', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33151'] 2611,32520594,Fast-Acting Insulin Aspart Use with the MiniMed™ 670G System.,"BACKGROUND This study assessed the efficacy and safety of ultra-rapid insulin Fiasp® in the hybrid closed-loop MiniMed™ 670G system. METHODS This was a pilot randomized, double-blinded, cross-over study among established MiniMed™ 670G users comparing percent time in range (TIR) and hypoglycemia for Novolog® and Fiasp®. Following two weeks optimization with their home insulin, participants were randomized to receive Novolog® or Fiasp® for two weeks, followed by the other insulin for the next two weeks. Data from the second week of blinded insulin use was analyzed to allow one week for 670G adaptation. During the second week, individuals were asked to eat the same breakfast for three days to assess differences in meal pharmacodynamics. RESULTS Nineteen adults were recruited with mean age of 40±18 years, diabetes duration of 27±12 years and median HbA1c of 7.1 (6.9,7.5)%, using 0.72 (0.4,1.2) units/kg/day. For Novolog® and Fiasp® respectively the %TIR (70-180mg/dL) was 75.3±9.5 and 78.4 ±9.3; %time <70mg/dL was 3.1±2.1 and 2.3±2.0; %time >180mg/dL was 21.6±9.0 and 19.3±8.9; mean glucose was 147±12 and 146±12mg/dL; coefficient of variation was 28.6±4.5% and 26.8±4.4%; %time in Auto Mode 86.4±9.2 and 84.4±9.2. All comparisons were non-significant for insulin type. Total daily dose (Novolog® 48.8±28.4 vs. Fiasp® 52.4±31.7 units; p=0.01) and daily basal (Novolog® 17.6 (15.5,33.8) vs. Fiasp® 19.1 (15.3,38.5) units; p=0.07) correlated with TIR and %time >180mg/dL. For insulin delivery in Auto Mode there was no statistical difference in total daily dose or daily basal between arms. Paired analysis for matched breakfast meals revealed no significant differences in time to maximum glucose, peak glucose or glucose excursion. CONCLUSIONS In this pilot study the use of either Novolog® or Fiasp® in a commercially available MiniMed™ 670G system operating in Auto Mode resulted in clinically similar glycemic outcomes, with a slight increase in daily insulin requirements using Fiasp®.",2020,"Paired analysis for matched breakfast meals revealed no significant differences in time to maximum glucose, peak glucose or glucose excursion.","['Nineteen adults were recruited with mean age of 40±18 years, diabetes duration of 27±12 years and median HbA1c of 7.1 (6.9,7.5)%, using 0.72 (0.4,1.2) units/kg/day', 'established MiniMed™ 670G users comparing percent time in range (TIR) and hypoglycemia for Novolog® and Fiasp®']","['ultra-rapid insulin Fiasp®', 'Novolog® or Fiasp®']","['total daily dose or daily basal', 'time to maximum glucose, peak glucose or glucose excursion', 'mean glucose', 'daily insulin requirements']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517475', 'cui_str': '0.72'}, {'cui': 'C1532634', 'cui_str': 'U/kg/day'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",19.0,0.289761,"Paired analysis for matched breakfast meals revealed no significant differences in time to maximum glucose, peak glucose or glucose excursion.","[{'ForeName': 'Liana J', 'Initials': 'LJ', 'LastName': 'Hsu', 'Affiliation': 'Stanford University, 6429, Division of Endocrinology, Department of Pediatrics, Stanford, California, United States.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Stanford University, 6429, Division of Endocrinology, Department of Pediatrics, Stanford, California, United States.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Basina', 'Affiliation': 'Stanford University, 6429, Division of Endocrinology, Department of Medicine, Stanford, California, United States.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Stanford University, 6429, Division of Endocrinology, Department of Pediatrics, Stanford, California, United States.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'von Eyben', 'Affiliation': 'Stanford University, 6429, Department of Radiation Oncology, Stanford, California, United States; rieve@stanford.edu.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Stanford University, 6429, Stanford Diabetes Research Center, Stanford, California, United States; jjwang01@stanford.edu.'}, {'ForeName': 'Rayhan Adi', 'Initials': 'RA', 'LastName': 'Lal', 'Affiliation': 'Stanford University, 6429, Division of Endocrinology, Department of Pediatrics, Stanford, California, United States.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0083'] 2612,32520602,Use of Indirect Laryngeal Biopsy Forceps to Treat Epiglottic Abscess.,"OBJECTIVES To evaluate the efficacy of indirect laryngeal biopsy forceps in the treatment of epiglottic abscess (EA). METHODS Twenty patients were diagnosed with EA in our department and were randomly divided into group A (indirect laryngeal biopsy forceps combined antibiotics) and group B (antibiotics only). Demographics, the degree of epiglottic and arytenoid swelling, and inflammatory cells were collected for analysis. The drainage of EA was performed under local anesthesia in conscious patients with indirect laryngeal biopsy forceps and 70° direct laryngoscopes. The length of symptomatic relief and length of hospitalization were assessed. RESULTS Ten patients were treated with indirect laryngeal biopsy forceps under the view of the 70° direct laryngoscopes combined with intravenous antibiotics, whereas the other 10 patients were treated with antibiotics only. The differences between the 2 groups had no statistical significance in age, gender, white blood cell count, neutrophils count, and the percent of neutrophils, abscess size, and scope classification at the time of diagnosis. The length of hospitalization and length of symptomatic relief was significantly lower in patients treated with indirect laryngeal biopsy forceps combined antibiotics than those treated with antibiotics only. CONCLUSIONS Indirect laryngeal biopsy forceps are safe and effective method to treat EA, which shorten the hospitalization and has the advantages of cost savings and convenience.",2020,"The length of hospitalization and length of symptomatic relief was significantly lower in patients treated with indirect laryngeal biopsy forceps combined antibiotics than those treated with antibiotics only. ","['conscious patients with indirect laryngeal biopsy forceps and 70° direct laryngoscopes', 'Twenty patients were diagnosed with EA in our department', 'epiglottic abscess (EA']","['Indirect Laryngeal Biopsy Forceps', 'indirect laryngeal biopsy forceps', 'indirect laryngeal biopsy forceps combined antibiotics', 'indirect laryngeal biopsy forceps combined antibiotics) and group B (antibiotics only', 'indirect laryngeal biopsy forceps under the view of the 70° direct laryngoscopes combined with intravenous antibiotics']","['length of hospitalization and length of symptomatic relief', 'length of symptomatic relief and length of hospitalization', 'degree of epiglottic and arytenoid swelling, and inflammatory cells']","[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C3877733', 'cui_str': 'Laryngeal biopsy forceps'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C3877733', 'cui_str': 'Laryngeal biopsy forceps'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0003943', 'cui_str': 'Arytenoid cartilage structure'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}]",20.0,0.0164763,"The length of hospitalization and length of symptomatic relief was significantly lower in patients treated with indirect laryngeal biopsy forceps combined antibiotics than those treated with antibiotics only. ","[{'ForeName': 'Xiufa', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Departments of Facial Plastic and Reconstructive Surgery, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Fang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Chunsheng', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Eye, Ear, Nose, and Throat Hospital of Fudan University, Shanghai, People's Republic of China.""}]","Ear, nose, & throat journal",['10.1177/0145561320930644'] 2613,32520613,Cardiovascular Event Risks Associated With Masked Nocturnal Hypertension Defined by Home Blood Pressure Monitoring in the J-HOP Nocturnal Blood Pressure Study.,"There is no information regarding the potential association between cardiovascular disease (CVD) event risks and masked nocturnal hypertension defined by home blood pressure (BP) monitoring. We sought to examine this association in a general practice population. For this purpose, we used data from the J-HOP (Japan Morning Surge-Home Blood Pressure) Nocturnal BP Study, which recruited 2745 high-cardiovascular-risk participants (mean [SD] age, 63.6 [10.4] years; 48.7% men; 82.7% on antihypertensive medications). Nocturnal home BPs (HBPs) were measured at 2:00, 3:00, and 4:00 AM using a validated, automated HBP device for 14 consecutive days. The average (SD) of nocturnal HBP measures was 17.1 (13.5). The percentages of participants with controlled BP (nocturnal HBP <120/70 mm Hg and average morning and evening BP <135/85 mm Hg), daytime hypertension (nocturnal HBP <120/70 mm Hg and average morning and evening BP ≥135/85 mm Hg), masked nocturnal hypertension (nocturnal HBP ≥120/70 mm Hg and average morning and evening BP <135/85 mm Hg), and sustained hypertension (nocturnal HBP ≥120/70 mm Hg and average morning and evening BP ≥135/85 mm Hg) were 31.7%, 7.9%, 26.7%, and 33.7%, respectively. During a median 7.6-year follow-up (19 519 person-years), 162 CVD events occurred. The cumulative incidence of CVD events was higher in those with masked nocturnal hypertension and sustained hypertension than in the controlled BP group. Results from Cox models suggested that masked nocturnal hypertension (adjusted hazard ratio, 1.57 [95% CI, 1.00-2.46]) and sustained hypertension (adjusted hazard ratio, 1.97 [95% CI, 1.26-3.06]) were associated with increased risk of CVD events. Participants with masked nocturnal hypertension defined by HBP monitoring are at high risk of future CVD events.",2020,The cumulative incidence of CVD events was higher in those with masked nocturnal hypertension and sustained hypertension than in the controlled BP group.,"['Participants with masked nocturnal hypertension defined by HBP monitoring are at high risk of future CVD events', 'Nocturnal BP Study, which recruited 2745 high-cardiovascular-risk participants (mean [SD] age, 63.6 [10.4] years; 48.7% men; 82.7% on antihypertensive medications']",['J-HOP (Japan Morning Surge-Home Blood Pressure'],"['masked nocturnal hypertension', 'average (SD) of nocturnal HBP measures', 'cumulative incidence of CVD events', 'sustained hypertension', 'risk of CVD events', 'daytime hypertension (nocturnal HBP', 'Nocturnal home BPs (HBPs', 'Cardiovascular Event Risks']","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}]",,0.169557,The cumulative incidence of CVD events was higher in those with masked nocturnal hypertension and sustained hypertension than in the controlled BP group.,"[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan (T.F., S.H., H.K., K.K.).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan (T.F., S.H., H.K., K.K.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kanegae', 'Affiliation': 'From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan (T.F., S.H., H.K., K.K.).'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'From the Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan (T.F., S.H., H.K., K.K.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14790'] 2614,32312152,Cyberbullying and cybervictimization: Does gender matter?,"The purpose of the present study was to evaluate gender effects on college students' judgements about a hypothetical episode of cyberbullying on Facebook that resulted in the suicide of a cybervictim. A total of 176 undergraduate students at a midsize public university in the Northeast served as participants. Four one-page versions of a hypothetical trial transcript detailing a cyberbullying case were utilized. Participants were randomly assigned to one of four conditions: male cyberbully/male cybervictim, male cyberbully/female cybervictim, female cyberbully/male cybervictim, and female cyberbully/female cybervictim. After reading one of the trial transcripts, participants rated eight variables, including criminal guilt and intent of the cyberbully, responsibility of entities involved, and appropriate punishment for the cyberbully. Results revealed significant differences in judgments based on the gender of the cyberbully, cybervictim, and participant.",2020,"Results revealed significant differences in judgments based on the gender of the cyberbully, cybervictim, and participant.","['176 undergraduate students at a midsize public university in the Northeast served as participants', ""college students' judgements"", 'Participants were randomly assigned to one of four conditions: male cyberbully/male cybervictim, male cyberbully/female cybervictim, female cyberbully/male cybervictim, and female cyberbully/female cybervictim']",['Cyberbullying and cybervictimization'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],176.0,0.0551653,"Results revealed significant differences in judgments based on the gender of the cyberbully, cybervictim, and participant.","[{'ForeName': 'Kristy L', 'Initials': 'KL', 'LastName': 'Marr', 'Affiliation': 'Department of Psychology, University of Massachusetts Lowell, MA, USA.'}, {'ForeName': 'Mary N', 'Initials': 'MN', 'LastName': 'Duell', 'Affiliation': 'Department of Psychology, University of Massachusetts Lowell, MA, USA.'}]",Psychological reports,['10.1177/0033294120916868'] 2615,32321288,Low frequency activation of the sphenopalatine ganglion does not induce migraine-like attacks in migraine patients.,"INTRODUCTION Cephalic autonomic symptoms occur in 27‒73% of migraine patients during attacks. The role of parasympathetic activation in migraine attack initiation remains elusive. Low frequency stimulation of the sphenopalatine ganglion increases parasympathetic outflow. In this study, we hypothesized that low frequency stimulation of the sphenopalatine ganglion would provoke migraine-like attacks in migraine patients. METHODS In a double-blind randomized sham-controlled crossover study, 12 migraine patients with a sphenopalatine ganglion neurostimulator received low frequency or sham stimulation for 30 min on two separate days. We recorded headache characteristics, cephalic autonomic symptoms, ipsilateral mechanical perception and pain thresholds, mean blood flow velocity in the middle cerebral artery (V MCA ) and diameter of the superficial temporal artery during and after stimulation. RESULTS Five patients (42%) reported a migraine-like attack after low frequency stimulation compared to six patients (50%) after sham ( p  = 1.000). We found a significant increase in mechanical detection thresholds during low frequency stimulation compared to baseline ( p  = 0.007). Occurrence of cephalic autonomic symptoms and changes in mechanical perception thresholds, V MCA and diameter of the superficial temporal artery showed no difference between low frequency stimulation compared to sham ( p  = 0.533). CONCLUSION Low frequency stimulation of the sphenopalatine ganglion did not induce migraine-like attacks or autonomic symptoms in migraine patients. These data suggest that increased parasympathetic outflow by the sphenopalatine ganglion neurostimulator does not initiate migraine-like attacks. Study protocol: ClinicalTrials.gov registration number NCT02510742.",2020,We found a significant increase in mechanical detection thresholds during low frequency stimulation compared to baseline ( p  = 0.007).,"['12 migraine patients with a sphenopalatine ganglion neurostimulator received low frequency or sham stimulation for 30 min on two separate days', 'migraine patients']",['sphenopalatine ganglion'],"['migraine-like attacks or autonomic symptoms', 'migraine-like attacks', 'Occurrence of cephalic autonomic symptoms and changes in mechanical perception thresholds, V MCA and diameter of the superficial temporal artery', 'headache characteristics, cephalic autonomic symptoms, ipsilateral mechanical perception and pain thresholds, mean blood flow velocity in the middle cerebral artery (V MCA ) and diameter of the superficial temporal artery during and after stimulation', 'mechanical detection thresholds', 'migraine-like attack', 'parasympathetic outflow']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229062', 'cui_str': 'Structure of sphenopalatine ganglion'}, {'cui': 'C0582124', 'cui_str': 'Neurostimulator'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0229062', 'cui_str': 'Structure of sphenopalatine ganglion'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",12.0,0.0541007,We found a significant increase in mechanical detection thresholds during low frequency stimulation compared to baseline ( p  = 0.007).,"[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Henrik Winther', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Caparso', 'Affiliation': 'Aurea Medical, LLC, Cleveland, OH, USA.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420921156'] 2616,32326749,Acceptability and feasibility of a Japanese version of STrAtegies for RelaTives (START-J): A manualized coping strategy program for family caregivers of relatives living with dementia.,"The rising older population in Japan is associated with a rise in cases of dementia. Support for the increased number of family caregivers of people living with dementia is crucial, as caring may negatively affect a family caregiver's health. This study seeks to evaluate the feasibility and applicability of a recently developed Japanese version of START (STrAtegies for RelaTives). START is a psychosocial coping intervention program developed in the United Kingdom that has been shown to improve caregivers' mood and quality of life in a randomized controlled trial. We made changes to START (e.g., idioms, linguistic nuance, and providing care insurance information suited for Japan) to make it culturally appropriate. Fourteen Japanese female family caregivers of relatives with mild dementia (n = 10) or mild cognitive impairment (n = 4) were referred to the study, but six were excluded owing to illness and busyness. This single-arm study had a before-after trial evaluating psychological outcomes including depression, anxiety, quality of life, and subjective care burden. The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions. The mean program satisfaction score was 30.25 (standard deviation = 2.25) out of a potential 32. The results suggest that it is feasible and acceptable to deliver START in Japanese and based on the results of analysis using a linear mixed model, there is initial indication that the intervention improved family caregivers' quality of life, depressive symptoms, and care burden.",2020,"The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions.","['family caregivers of relatives living with dementia', 'RelaTives (START-J', 'Fourteen Japanese female family caregivers of relatives with mild dementia (n\u2009=\u200910) or mild cognitive impairment (n\u2009=\u20094) were referred to the study, but six were excluded owing to illness and busyness', 'RelaTives']","['manualized coping strategy program', 'Japanese version']","[""family caregivers' quality of life, depressive symptoms, and care burden"", 'mean program satisfaction score', 'depression, anxiety, quality of life, and subjective care burden', 'acceptance retention and satisfaction rate']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0557089', 'cui_str': 'Relatives surviving - finding'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",14.0,0.0494264,"The acceptance retention and satisfaction rate suggest the feasibility and acceptability of the START program; 8/14 (>55%) eligible, prospective participants consented and were included in this study, all (8/8) of whom completed all START sessions.","[{'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Kashimura', 'Affiliation': 'Department of Medical Psychology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Rapaport', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'Department of Medical Psychology, Nippon Medical School, Tokyo, Japan; Dementia Centre, Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Ishiwata', 'Affiliation': 'Department of Neurology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Tateno', 'Affiliation': 'Department of Psychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Nogami', 'Affiliation': 'Department of Neurology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Research Team for Social Participation and Community Health, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Kawanishi', 'Affiliation': 'Department of Clinical Psychology, Graduate School of Education, Naruto University of Education, Tokushima, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kawashima', 'Affiliation': 'Department of Psycho-Social Studies, School of Arts and Letters, Meiji University, Tokyo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kitamura', 'Affiliation': 'Dementia Centre, Nippon Medical SchoolMusashi Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, UK; Camden and Islington NHS Foundation Trust, London, UK.'}]","Dementia (London, England)",['10.1177/1471301220919938'] 2617,32340471,Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine.,"BACKGROUND This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials. METHODS Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug antibody status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the potential relationship between treatment-emergent antidrug antibodies and hypersensitivity events or adverse events related to injection sites. FINDINGS Across studies, 5.9-11.2% of patients had baseline antidrug antibodies. The incidence of treatment-emergent antidrug antibodies was 2.6-12.4% in the galcanezumab group and 0.5-1.7% in the placebo group. The majority of treatment-emergent antidrug antibodies were detected approximately 3-6 months after first study drug dose. Overall, the observed antidrug antibody titer did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy. There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. INTERPRETATION These data showed that immunogenicity did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or the efficacy and hypersensitivity profile of galcanezumab in patients with migraine.",2020,"There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. ","['patients with episodic or chronic migraine', 'patients with migraine']","['galcanezumab', 'placebo']","['hypersensitivity events or adverse events', 'efficacy and hypersensitivity profile of galcanezumab', 'galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy', 'incidence of treatment-emergent antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0430344', 'cui_str': 'Allergy profile'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.0992328,"There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies. ","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hindiyeh', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Anglin', 'Affiliation': 'Eli Lilly Canada Inc, Toronto, ON, Canada.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kalidas', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Hodsdon', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kielbasa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Moser', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garces', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420920642'] 2618,32430908,Changes in perampanel levels during de-induction: Simulations following carbamazepine discontinuation.,"OBJECTIVE To evaluate the time course of changes in perampanel levels when co-administered with carbamazepine, and following carbamazepine discontinuation, using a physiologically based pharmacokinetic (PBPK) model. METHODS The PBPK model was developed, verified using clinical PK data, and used to simulate the effect of abrupt discontinuation and down-titration (75 mg twice daily [bid]/wk) of co-administered carbamazepine 300 mg bid on the PK of perampanel once daily (qd). Perampanel dose tapering (8-4 mg) and up-titration (2-6 mg) were simulated during abrupt carbamazepine 300 mg bid discontinuation to identify a titration schedule that minimizes changes in perampanel plasma concentrations. RESULTS The PBPK model accurately reproduced perampanel plasma concentration-time profiles from clinical studies in single- and multiple-dose regimen simulations, including multiple-dose carbamazepine co-administration. The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days). Perampanel dose tapering (8-4 mg) at abrupt carbamazepine discontinuation produced minimal changes in steady-state concentrations, which returned to the levels observed during carbamazepine co-administration in ~15 days from the time of carbamazepine discontinuation. When perampanel was up-titrated in the presence of carbamazepine, return to steady state occurred more slowly when carbamazepine was down-titrated weekly (~45 days) vs abrupt discontinuation (~24 days). CONCLUSION This PBPK model simulated and predicted optimal perampanel dose tapering and up-titration schedules for maintaining perampanel levels during conversion to monotherapy. These results may guide physicians when managing conversion from perampanel polytherapy with concomitant enzyme-inducing anti-seizure medications to monotherapy.",2020,The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days).,[],"['carbamazepine', 'carbamazepine 300\xa0mg bid on the PK of perampanel', 'Perampanel', 'perampanel']","['time course of return to pre-induced perampanel levels', 'steady-state concentrations', 'perampanel levels']",[],"[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0984515', 'cui_str': 'Carbamazepine 300 MG'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]","[{'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0293076,The time course of return to pre-induced perampanel levels occurred more slowly following carbamazepine down-titration (~48 days after first down-titration) vs abrupt discontinuation (~25 days).,"[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Schuck', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Ferry', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hussein', 'Affiliation': 'Eisai Ltd., Hatfield, Hertfordshire, UK.'}]",Acta neurologica Scandinavica,['10.1111/ane.13286'] 2619,31617430,Therapeutic effect of one-time root canal treatment for irreversible pulpitis.,"OBJECTIVE To compare the therapeutic effects of one-time root canal treatment versus two-time treatment in patients with irreversible pulpitis. METHODS We classified 130 patients into a one-time treatment group (group A; n = 68) and a two-time treatment group (group B; n = 62) according to the number of patient visits. Clinical efficacy at 6 months and 1 year follow-ups as well as serum levels of interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein before and 1 week after endodontic treatment were observed. Additionally, the level of treatment satisfaction between the two groups was compared, and the degree of pain was evaluated using the visual analogue scale. RESULT One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B. CONCLUSION One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.",2019,"One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B. CONCLUSION One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.","['patients with irreversible pulpitis', 'irreversible pulpitis']",['time root canal treatment'],"['Clinical efficacy', 'level of treatment satisfaction', 'visual analogue scale', 'postoperative pain', 'degree of pain', 'serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels', 'visual analogue scale scores', 'serum levels of interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",130.0,0.0149998,"One week after treatment, serum interleukin-6, tumor necrosis factor alpha, and high-sensitivity C-reactive protein levels were significantly decreased in the two groups; however, levels in group B were significantly lower than those in group A. Additionally, visual analogue scale scores of patients in group A were significantly higher than those of patients in group B. CONCLUSION One-time root canal therapy can effectively improve postoperative pain and the expression of inflammatory factors in the serum of patients undergoing treatment.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chengxia', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Endodontics, Stomatological Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}]",The Journal of international medical research,['10.1177/0300060519879287'] 2620,31653175,Clinical associations of an updated medication effect score for measuring diabetes treatment intensity.,"OBJECTIVES The medication effect score reflects overall intensity of a diabetes regimen by consolidating dosage and potency of agents used. Little is understood regarding how medication intensity relates to clinical factors. We updated the medication effect score to account for newer agents and explored associations between medication effect score and patient-level clinical factors. METHODS Cross-sectional analysis of baseline data from a randomized controlled trial involving 263 Veterans with type 2 diabetes and hemoglobin A1c levels ≥8.0% (≥7.5% if under age 50). Medication effect score was calculated for all patients at baseline, alongside additional measures including demographics, comorbid illnesses, hemoglobin A1c, and self-reported psychosocial factors. We used multivariable regression to explore associations between baseline medication effect score and patient-level clinical factors. RESULTS Our sample had a mean age of 60.7 ( SD  = 8.2) years, was 89.4% male, and 57.4% non-White. Older age and younger onset of diabetes were associated with a higher medication effect score, as was higher body mass index. Higher medication effect score was significantly associated with medication nonadherence, although not with hemoglobin A1c, self-reported hypoglycemia, diabetes-related distress, or depression. DISCUSSION We observed several expected associations between an updated medication effect score and patient-level clinical factors. These associations support the medication effect score as an appropriate measure of diabetes regimen intensity in clinical and research contexts.",2019,"Higher medication effect score was significantly associated with medication nonadherence, although not with hemoglobin A1c, self-reported hypoglycemia, diabetes-related distress, or depression. ","['263 Veterans with type 2 diabetes and hemoglobin A1c levels ≥8.0% (≥7.5% if under age 50', 'Our sample had a mean age of 60.7 ( SD \u2009=\u20098.2) years, was 89.4% male, and 57.4% non-White']",[],"['demographics, comorbid illnesses, hemoglobin A1c, and self-reported psychosocial factors', 'Medication effect score', 'hemoglobin A1c, self-reported hypoglycemia, diabetes-related distress, or depression']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",263.0,0.0350983,"Higher medication effect score was significantly associated with medication nonadherence, although not with hemoglobin A1c, self-reported hypoglycemia, diabetes-related distress, or depression. ","[{'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, WI, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sagalla', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barton Bradley', 'Affiliation': 'Richmond Diabetes and Endocrinology, Bon Secours Medical Group, Richmond, VA, USA.'}, {'ForeName': 'Moahad', 'Initials': 'M', 'LastName': 'Dar', 'Affiliation': 'Division of Endocrinology and Metabolism, East Carolina University, Greenville NC, USA.'}, {'ForeName': 'Stéphanie B', 'Initials': 'SB', 'LastName': 'Mayer', 'Affiliation': 'Hunter Holmes McGuire Veterans Affairs Medical Center, Division of Endocrinology and Metabolism, Richmond, VA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Medical Center, Durham, NC, USA.'}]",Chronic illness,['10.1177/1742395319884096'] 2621,31674216,Exploring the utility of self-determination theory in complex interventions in multimorbidity: A qualitative analysis of patient experiences of the CARE Plus intervention.,"OBJECTIVES CARE Plus is a primary-care-based complex intervention for patients with multimorbidity living in areas of high socioeconomic deprivation. This study explores patients' experience of the intervention and whether self-determination theory is useful to understand reported impacts. METHOD Thematic analysis of semistructured interviews of 14 participants conducted during a randomised controlled trial of CARE Plus. Improvement in wellbeing in daily lives following CARE Plus was estimated from participants' accounts of their experiences of the intervention. FINDINGS Participants valued the CARE Plus consultations irrespective of perceived improvements. Six participants reported changes in wellbeing that improved daily life, three reported slight improvement (not impacting daily life) and five no improvement. Evidence of satisfaction of the three major self-determination theory psychological needs - relatedness, competence and autonomy - was prominent in the accounts of those experiencing improved wellbeing in daily life; this group also spoke in ways congruent with more self-determined motivational regulation. These changes were not evident in those with little or no improvement in wellbeing. DISCUSSION This study suggests self-determination theory has utility in understanding the impact of CARE Plus on patients and may be a useful theory to inform development of future interventions to improve outcomes for patients with multimorbidity.",2019,"Evidence of satisfaction of the three major self-determination theory psychological needs - relatedness, competence and autonomy - was prominent in the accounts of those experiencing improved wellbeing in daily life; this group also spoke in ways congruent with more self-determined motivational regulation.","['patients with multimorbidity living in areas of high socioeconomic deprivation', 'patients with multimorbidity', 'multimorbidity', 'Thematic analysis of semistructured interviews of 14 participants conducted during a randomised controlled trial of CARE Plus']",[],"['changes in wellbeing that improved daily life', 'wellbeing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",14.0,0.0747707,"Evidence of satisfaction of the three major self-determination theory psychological needs - relatedness, competence and autonomy - was prominent in the accounts of those experiencing improved wellbeing in daily life; this group also spoke in ways congruent with more self-determined motivational regulation.","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'McCallum', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hanlon', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychology, Glasgow Caledonian University, Glasgow, Scotland.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'Mercer', 'Affiliation': 'Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, University of Edinburgh, Old Medical School, Edinburgh, Scotland.'}]",Chronic illness,['10.1177/1742395319884106'] 2622,31707844,Australian long-term care personnel's knowledge and attitudes regarding palliative care for people with advanced dementia.,"This study aimed to describe Australian long-term care (LTC) personnel's knowledge and attitudes concerning palliative care for residents with advanced dementia, and explore relationships with LTC facility/personnel characteristics. An analysis was undertaken of baseline data from a cluster randomised controlled trial of facilitated family case conferencing for improving palliative care of LTC residents with advanced dementia (the 'IDEAL Study'). Participants included any LTC personnel directly involved in residents' care. Knowledge and attitudes concerning palliative care for people with advanced dementia were measured using the questionnaire on Palliative Care for Advanced Dementia. Univariate and multivariate analyses explored relationships between personnel knowledge/attitudes and facility/personnel characteristics. Of 307 personnel in the IDEAL Study, 290 (94.5%) from 19/20 LTCFs provided sufficient data for inclusion. Participants included 9 (2.8%) nurse managers, 59 (20.5%) registered nurses, 25 (8.7%) enrolled nurses, 187 (64.9%) assistants in nursing/personal care assistants and 9 (3.1%) care service employees. In multivariate analyses, a facility policy not to rotate personnel through dementia units was the only variable associated with more favourable overall personnel knowledge and attitudes. Other variables associated with favourable knowledge were a designation of nursing manager or registered or enrolled nurse, and having a preferred language of English. Other variables associated with favourable attitudes were tertiary level of education and greater experience in dementia care. Like previous international research, this study found Australian LTC personnel knowledge and attitudes regarding palliative care for people with advanced dementia to be associated with both facility and personnel characteristics. Future longitudinal research is needed to better understand the relationships between knowledge and attitudes, as well as between these attributes and quality of care.",2019,"Like previous international research, this study found Australian LTC personnel knowledge and attitudes regarding palliative care for people with advanced dementia to be associated with both facility and personnel characteristics.","[""Participants included any LTC personnel directly involved in residents' care"", 'residents with advanced dementia', 'people with advanced dementia', ""LTC residents with advanced dementia (the 'IDEAL Study"", 'Participants included 9 (2.8%) nurse managers, 59 (20.5%) registered nurses, 25 (8.7%) enrolled nurses, 187 (64.9%) assistants in nursing/personal care assistants and 9 (3.1%) care service employees']",['facilitated family case conferencing'],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454680', 'cui_str': 'Nurse manager'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",[],,0.0787066,"Like previous international research, this study found Australian LTC personnel knowledge and attitudes regarding palliative care for people with advanced dementia to be associated with both facility and personnel characteristics.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Luckett', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Luscombe', 'Affiliation': 'School of Rural Health, The University of Sydney, Orange/Dubbo, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beattie', 'Affiliation': 'School of Nursing, Queensland University of Technology, Herston, Australia.'}, {'ForeName': 'Lynnette', 'Initials': 'L', 'LastName': 'Chenoweth', 'Affiliation': 'Centre for Healthy Brain Ageing, University of New South Wales, Randwick, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Davidson', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Ultimo, Australia; School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Centre for Health Research and Evaluation (CHERE), Faculty of Business, University of Technology Sydney, Haymarket, Australia.'}, {'ForeName': 'Dimity', 'Initials': 'D', 'LastName': 'Pond', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Medicine, The University of Queensland, St Lucia, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Ultimo, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Ingham Institute for Applied Medical Research, Liverpool, Australia.'}]","Dementia (London, England)",['10.1177/1471301219886768'] 2623,31760855,"The sustained effects of extending cardiac rehabilitation with a six-month telemonitoring and telecoaching programme on fitness, quality of life, cardiovascular risk factors and care utilisation in CAD patients: The TeleCaRe study.","INTRODUCTION The aim of this study was to assess the acute and sustained effects of a six-month heart-rate-based telerehabilitation programme, following the completion of cardiac rehabilitation (CR), on peak oxygen uptake (peakVO 2 ), quality of life (QoL), cardiovascular risk factors and care utilisation in patients with coronary artery disease (CAD). METHODS A total of 122 patients with CAD were randomised, after the completion of CR, to an intervention group with six months of telemonitoring and telecoaching (TELE) or a control group with a traditional six-month follow-up programme with monthly calls (CON). The primary outcome was peakVO 2 at 12 months, to assess the sustained effects of TELE. The secondary outcomes included QoL, cardiovascular risk factors (lipid spectrum), major adverse cardiovascular events (MACE) and habitual physical activity. RESULTS PeakVO 2 increased significantly from baseline to 12 months in TELE (+2.5 mL·kg -1 min -1 (95% CI 1.5-3.2)) and CON (+1.9 mL·kg -1 min -1 (95% CI 1.0-2.5)), and did not differ between groups (P = 0.28). Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time. DISCUSSION Extending CR with a heart-rate-based telerehabilitation programme did not yield additional sustainable health benefits compared with regular care with monthly telephone calls. These observations highlight that both telerehabilitation and regular care with monthly telephone calls may prevent the typically observed reductions in peakVO 2 following the completion of a CR programme.Trial registration: Dutch Trial Register NL4140 (registered 6 December 2014).",2019,"Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time. ","['122 patients with CAD', 'patients with coronary artery disease (CAD', 'CAD patients']","['TELE', 'telecoaching programme', 'telemonitoring and telecoaching (TELE) or a control group with a traditional six-month follow-up programme with monthly calls (CON', 'six-month heart-rate-based telerehabilitation programme', 'CON', 'cardiac rehabilitation (CR']","['QoL, cardiovascular risk factors (lipid spectrum), major adverse cardiovascular events (MACE) and habitual physical activity', 'sustained effects of TELE', 'total cholesterol', 'peak oxygen uptake (peakVO 2 ), quality of life (QoL), cardiovascular risk factors and care utilisation', 'fitness, quality of life, cardiovascular risk factors and care utilisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",122.0,0.22025,"Similarly, QoL (P = 0.31), total cholesterol (P = 0.45), MACE (P = 0.86) did not differ between groups and in time. ","[{'ForeName': 'Johan A', 'Initials': 'JA', 'LastName': 'Snoek', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}, {'ForeName': 'Esther P', 'Initials': 'EP', 'LastName': 'Meindersma', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}, {'ForeName': 'Leonie F', 'Initials': 'LF', 'LastName': 'Prins', 'Affiliation': 'Diagram, Zwolle, The Netherlands.'}, {'ForeName': 'Arnoud Wj', 'Initials': 'AW', 'LastName': ""Van't Hof"", 'Affiliation': 'Cardiology Department, Maastricht UMC, Maastricht, The Netherlands.'}, {'ForeName': 'Menko-Jan', 'Initials': 'MJ', 'LastName': 'de Boer', 'Affiliation': 'Cardiology Department, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Thijs Mh', 'Initials': 'TM', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Ed P', 'Initials': 'EP', 'LastName': 'de Kluiver', 'Affiliation': '*Authors contributed equally to the study. Isala Heart Centre, Zwolle, The Netherlands.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19885793'] 2624,31802692,Effects of probiotics combined with early enteral nutrition on endothelin-1 and C-reactive protein levels and prognosis in patients with severe traumatic brain injury.,"OBJECTIVE To investigate the effects of probiotics combined with early enteral nutrition on levels of endothelin-1 (ET-1), C-reactive protein (CRP), and inflammatory factors, and on the prognosis of patients with severe traumatic brain injury (TBI). METHODS We enrolled 76 adults with severe TBI. The patients were divided randomly into two equal groups administered enteral nutrition with and without probiotics, respectively. Demographic and clinical data including age, sex, Glasgow Coma Scale score, Sequential Organ Failure Score, Acute Physiology, Chronic Health Score, hospitalization, mortality, and infections were recorded. RESULTS Serum levels of inflammatory factors gradually decreased with increasing treatment time in both groups. However, ET-1 at 15 days, and interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α, and CRP at 7 and 15 days decreased significantly more in the combined treatment group. Hospitalization duration and pulmonary infection rates were also significantly reduced in the combined compared with the enteral nutrition alone group. GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group. CONCLUSION Probiotics combined with early enteral nutrition could reduce serum levels of ET-1, CRP, and IL-6, IL-10, and TNF-α, and could thus improve the recovery of patients with severe TBI.",2019,"GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group. ","['patients with severe traumatic brain injury', '76 adults with severe TBI', 'patients with severe traumatic brain injury (TBI']","['probiotics combined with early enteral nutrition', 'enteral nutrition with and without probiotics']","['Demographic and clinical data including age, sex, Glasgow Coma Scale score, Sequential Organ Failure Score, Acute Physiology, Chronic Health Score, hospitalization, mortality, and infections', 'Hospitalization duration and pulmonary infection rates', 'Serum levels of inflammatory factors', 'levels of endothelin-1 (ET-1), C-reactive protein (CRP), and inflammatory factors', 'interleukin (IL)-6, IL-10, tumor necrosis factor (TNF)-α, and CRP', 'serum levels of ET-1, CRP, and IL-6, IL-10, and TNF-α', 'GCS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",76.0,0.0303593,"GCS scores at 15 days were significantly lower in the combined compared with the enteral nutrition group. ","[{'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Wan', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Guanhong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Joint Surgery, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Hepatobiliary Surgery, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Nutrition, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Sinopec Group Shengli Petroleum Administration Shengcai Hospital, Dongying, China.'}, {'ForeName': 'Xinhao', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Scientific Education Section, Shengli Oilfield Central Hospital, Dongying, China.'}]",The Journal of international medical research,['10.1177/0300060519888112'] 2625,31816075,"Morning Bright Light Treatment for Chronic Low Back Pain: Potential Impact on the Volatility of Pain, Mood, Function, and Sleep.","OBJECTIVES Most treatment outcome studies for people with chronic low back pain (CLBP) have based analyses on and reported only the mean levels of these factors. However, high levels of pain, mood, function, and sleep volatility may represent unique factors contributing to diminished quality of life. Our goal was to determine whether bright light treatment affected both mean levels of pain, mood, function, and sleep and reduced volatility in these outcomes. METHODS US military veterans with CLBP (N = 22) underwent an open trial with a seven-day baseline, followed by 13 days of a one-hour morning bright light treatment self-administered at their home and a 30-day follow-up. Participants completed daily diary measures at 12 Pm and 6 Pm every day during the three study epochs. RESULTS Using location scale modeling, results suggested that, in addition to being associated with changes in mean levels of pain intensity, pain interference, negative affect, and sleep quality, bright light treatment was also related to reductions in the volatility of pain intensity and negative affect, reductions that were largely maintained during follow-up. CONCLUSIONS Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares."" These findings underscore the potential importance of volatility as a future treatment target.",2020,"CONCLUSIONS Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","['US military veterans with CLBP (N\u2009=\u200922', 'people with chronic low back pain (CLBP', 'Chronic Low Back Pain']",['Morning Bright Light Treatment'],"['volatility of pain intensity', 'daily diary measures', 'pain flares', 'mean levels of pain intensity, pain interference, negative affect, and sleep quality', 'mean levels of pain, mood, function, and sleep and reduced volatility']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",22.0,0.0561542,"CONCLUSIONS Changes in mean levels and volatility were independent factors, suggesting that bright light treatment was related to participants experiencing fewer ""pain flares.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerhart', 'Affiliation': 'Department of Psychology, Central Michigan University, Mount Pleasant, Michigan.'}, {'ForeName': 'Muneer', 'Initials': 'M', 'LastName': 'Rizvydeen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kimura', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz235'] 2626,31854221,Sparing the pronator quadratus for volar plating of distal radius fractures: a comparative study of two methods.,"OBJECTIVES The objective of this study was to compare the results of two methods for sparing the pronator quadratus in volar plating of distal radius fractures. METHODS A total of 110 patients were randomized to volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method (Group B, 55 people). The operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications were recorded. RESULTS There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups. We found no significant differences in range of motion, grip strength, VAS scores, and DASH scores at any of the study intervals between the groups. Although neurapraxia of the superficial branch of the radial nerve was more common in Group B than in Group A (6.7% vs. 0%), the difference was not significant. CONCLUSIONS Both methods were efficient approaches for sparing the pronator quadratus and had similar clinical outcomes, but they had different indications.",2019,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","['110 patients', 'distal radius fractures']","['volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method']","['range of motion, grip strength, VAS scores, and DASH scores', 'mean operative time, radiation time, mean bone union time, or total complication rate', 'operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0224264', 'cui_str': 'Structure of brachioradialis muscle'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",110.0,0.0516226,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yun-Qiang', 'Initials': 'YQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gang-Qiang', 'Initials': 'GQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ya-Di', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060519893851'] 2627,31885300,Effect of metronidazole combined with autolytic debridement for the management of malignant wound malodor.,"OBJECTIVE To explore the effect of metronidazole combined with autolytic debridement for the management of malignant wound malodor. METHODS Patients with malignant wounds who underwent dressing change at a wound outpatient clinic from September 2016 to February 2019 were randomized to an observation group (36 patients) or a control group (37 patients). The observation group was treated with metronidazole combined with debridement gel while the control group received wet dressing therapy combined with silver sulfadiazine. Malodor control was compared between the two groups from treatment initiation to days 3 and 12 after dressing change, and the social impact scale was used to compare stigma caused by malodor between the groups before and after treatment. RESULTS The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group. There was no difference in stigma between the two groups before treatment, but stigma in the observation group was significantly lower than that in the control group after treatment. CONCLUSION Metronidazole combined with autolytic debridement can effectively reduce the malodor of cancerous wounds while controlling infection, and alleviate patient stigma caused by malodor.",2019,The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group.,"['malignant wound malodor', 'Patients with malignant wounds who underwent dressing change at a wound outpatient clinic from September 2016 to February 2019']","['Metronidazole combined with autolytic debridement', 'metronidazole combined with autolytic debridement', 'metronidazole combined with debridement gel while the control group received wet dressing therapy combined with silver sulfadiazine']","['stigma', 'social impact scale']","[{'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004372', 'cui_str': 'Autolysis'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0162468', 'cui_str': 'Social Impact'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0351736,The observation group had significantly superior malodor control on days 3 and 12 after dressing change compared with the control group.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The Journal of international medical research,['10.1177/0300060519889746'] 2628,32516820,Improving Pediatric Hearing Testing for Children with Developmental Delays: The Effects of Video Modeling on Child Compliance and Caregiver Stress.,"BACKGROUND For children with developmental delays (DDs) of any kind (e.g., global DDs, autism spectrum disorder, and Down syndrome), it is essential to understand if a hearing loss may be contributing to these delays. However, toddlers with DDs may have difficulty understanding directions, may be uncomfortable with a new situation, or may simply not want to complete the hearing testing tasks. Regardless of the reasons, noncompliant behaviors have a negative impact on hearing testing, which requires reliable behavioral responses from the child. PURPOSE The purpose of this study was to test a video intervention to improve hearing testing compliance in toddlers with developmental disabilities. RESEARCH DESIGN Double-blind randomized clinical trial. STUDY SAMPLE Twenty-four children with DDs between 24 and 36 months of age. INTERVENTION Video model of the hearing testing procedures. DATA COLLECTION AND ANALYSIS The primary child outcome measure was the number of hearing tests completed by the audiologist. Caregiver outcome included a parent survey of perceived stress level before and after the evaluation. RESULTS There was no significant difference between treatment and control groups regarding the number of hearing tests that were completed. Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group. CONCLUSIONS Pre-exposure to the hearing testing procedures did not significantly improve patient compliance but may reduce caregiver stress. Given the high rates of noncompliance in toddlers with DDs, audiologists may benefit from multiple strategies to help improve testing compliance.",2020,"Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group. ","['toddlers with developmental disabilities', 'Children with Developmental Delays', 'children with developmental delays (DDs', 'Twenty-four children with DDs between 24 and 36 months of age']","['video intervention', 'Video model of the hearing testing procedures', 'Video Modeling']","['patient compliance', 'Child Compliance and Caregiver Stress', 'number of hearing tests', 'stress', 'number of hearing tests completed by the audiologist', 'hearing testing compliance']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424605', 'cui_str': 'Developmental delay'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175838', 'cui_str': 'Audiologist'}, {'cui': 'C0018786', 'cui_str': 'Hearing examination'}]",24.0,0.0472382,"Parents in the treatment group reported less stress following the evaluation as compared with parents of children in the control group. ","[{'ForeName': 'Megan Y', 'Initials': 'MY', 'LastName': 'Roberts', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rosenwasser', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Phelan', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Hampton', 'Affiliation': 'The Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.18070'] 2629,32516821,Influence of Provider Interaction on Patient's Readiness Toward Audiological Services and Technology.,"BACKGROUND Patients and providers recognize the importance of patient-centered care. Clinical interactions, however, suggest that audiologists maintain their traditional provider-centered approach. PURPOSE The primary purpose of this study was to assess the degree to which provider interaction influenced patient readiness toward audiological services using the neobehavioral concept of need recognition described in consumer decision-making. RESEARCH DESIGN We used a randomized, within-group experimental approach using survey responses to quantify predisposed expectations on ten dimensions toward service and technology provision 2 weeks before and 2 weeks after an audiological assessment. Responses were also categorized as a function of the respondent-perceived professional setting of the provider (medical, rehabilitation, and consumer electronics). STUDY SAMPLE Survey respondents included 618 adults {186 males (mean age = 63.1 years; standard deviation [SD] = 5.3) and 432 females [mean age = 58.4 years; SD = 6.2]} from across the United States. DATA COLLECTION AND ANALYSIS Data were analyzed using two approaches. First, we used a two-step cluster analysis procedure that revealed natural groupings (i.e., profiles) of respondent characteristics of the ten dimensions. Second, we compared within-group mean differences between pre- and postappointment responses using a univariate analysis of variance, with mean differences reported as a function of professional setting and preappointment responses serving as the control condition. RESULTS Results revealed that the predisposed expectation profiles among the ten dimensions differed among the professional settings, with rehabilitation having the highest mean response values and consumer electronics having the least mean response values. A descriptive analysis indicated that respondents in the rehabilitation and medical settings presented the greatest interest in amplification before the patient-provider interaction, but the least interest afterward. In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings. CONCLUSIONS Overall, most respondents' predisposed expectations were unmet during their interaction with an audiologist. These expectations differed across professional settings, with the greatest unmet expectations observed in the rehabilitative and medical settings. Patient readiness is influenced by the behavior of the provider which, at present, appears to be a barrier to patients' acceptance of treatment options.",2020,"In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings. ",['SAMPLE\n\n\nSurvey respondents included 618 adults {186 males (mean age\u2009=\u200963.1 years; standard deviation [SD]\u2009=\u20095.3) and 432 females [mean age\u2009=\u200958.4 years; SD\u2009=\u20096.2]} from across the United States'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],[],618.0,0.0199614,"In addition, postappointment analyses revealed that providers failed statistically to meet patients' predisposed expectations in all three settings. ","[{'ForeName': 'Amyn M', 'Initials': 'AM', 'LastName': 'Amlani', 'Affiliation': 'Audigy Group, Vancouver, WA.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.19051'] 2630,32516832,MABp1 targeting interleukin-1alpha in hidradenitis suppurativa non-eligible for adalimumab treatment: Results of the open-label extension period.,"The emerging situation of patients with moderate-to-severe hidradenitis suppurativa (HS) non-eligible for or not responding to adalimumab generates the unmet need for new therapies. In a previous small-scale randomized clinical trial, MABp1 (also known as bermekimab) showed 60% treatment efficacy compared to 10% of placebo in such patient population. Eight of patients originally randomized to placebo treatment were allowed to participate in an open-label extension (OLE) treatment with MABp1 7.5mg/kg intravenously every other week. HS clinical response (HiSCR) was achieved at the end of the 12-week treatment in six patients (75%). The total number of inflammatory lesions and the international HS4 score were significantly decreased compared to the blinded placebo treatment period. Results support the use of bermekimab as treatment alternative for patients non-eligible or non-responding to adalimumab.",2020,The total number of inflammatory lesions and the international HS4 score were significantly decreased compared to the blinded placebo treatment period.,"['patients non-eligible or non-responding to', 'patients with moderate-to-severe hidradenitis suppurativa (HS) non-eligible for or not responding to', 'hidradenitis suppurativa non-eligible for adalimumab treatment']","['adalimumab', 'placebo']","['HS clinical response (HiSCR', 'total number of inflammatory lesions and the international HS4 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C2675212', 'cui_str': 'Spherocytosis, Type 4'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0312115,The total number of inflammatory lesions and the international HS4 score were significantly decreased compared to the blinded placebo treatment period.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kanni', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Argyropoulou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Dinarello', 'Affiliation': 'Department of Medicine, The University of Colorado in Denver, Denver, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simard', 'Affiliation': 'XBiotech, Austin, Texas, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Clinical and experimental dermatology,['10.1111/ced.14333'] 2631,32516894,Effectiveness of a Real-Time Ventilation Feedback Device for Guiding Adequate Minute Ventilation: A Manikin Simulation Study.,"Background and objectives: It is often challenging even for skilled rescuers to provide adequate positive pressure ventilation consistently. This study aimed to investigate the effectiveness of a newly developed real-time ventilation feedback device (RTVFD) that estimates tidal volume (TV) and ventilation interval (VI) in real time. Materials and methods: We conducted a randomised, crossover, manikin simulation study. A total of 26 medical providers were randomly assigned to the RTVFD-assisted ventilation (RAV) first group ( n = 13) and the non-assisted ventilation (NV) first group ( n = 13). Participants provided ventilation using adult and paediatric bag valves (BVs) for 2 min each. After a washout period, the simulation was repeated by exchanging the participants' groups. Results: The primary outcome was optimal TV in the RAV and NV groups using adult and paediatric BVs. A secondary outcome was optimal VI in the RAV and NV groups using adult and paediatric BVs. The proportions of optimal TV values were higher for the RAVs when using both adult and paediatric BVs (adult BV: 47.29% vs. 18.46%, p < 0.001; paediatric BV: 89.51% vs. 72.66%, p < 0.001) than for the NVs. The proportions of optimal VI were significantly higher in RAVs when using both adult and paediatric BVs than that in NVs (adult BV: 95.64% vs. 50.20%, p < 0.001; paediatric BV: 95.83% vs. 57.14%, p < 0.001). Additionally, we found that with paediatric BVs, the simulation had a higher OR for both optimal TV (13.26; 95% CI, 9.96-17.65; p < 0.001) and VI (1.32; 1.08-1.62, p = 0.007), regardless of RTVFD use. Conclusion: Real-time feedback using RTVFD significantly improves the TV and VI in both adult and paediatric BVs in a manikin simulation study.",2020,Conclusion: Real-time feedback using RTVFD significantly improves the TV and VI in both adult and paediatric BVs in a manikin simulation study.,['26 medical providers'],"['RTVFD', 'newly developed real-time ventilation feedback device (RTVFD', 'Real-Time Ventilation Feedback Device', 'RTVFD-assisted ventilation (RAV) first group ( n = 13) and the non-assisted ventilation (NV) first group']","['optimal VI in the RAV and NV groups using adult and paediatric BVs', 'estimates tidal volume (TV) and ventilation interval (VI) in real time', 'proportions of optimal TV values', 'optimal TV in the RAV and NV groups using adult and paediatric BVs']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",26.0,0.166221,Conclusion: Real-time feedback using RTVFD significantly improves the TV and VI in both adult and paediatric BVs in a manikin simulation study.,"[{'ForeName': 'Sejin', 'Initials': 'S', 'LastName': 'Heo', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Jongchul', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biomedical Engineering, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Hye Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Seoul 06351, Korea.'}, {'ForeName': 'Hee', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Won Chul', 'Initials': 'WC', 'LastName': 'Cha', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Taerim', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56060278'] 2632,32516959,Betaine Supplementation Does Not Improve Muscle Hypertrophy or Strength Following 6 Weeks of Cross-Fit Training.,"We aim to investigate the effect of 6 weeks of betaine supplementation on body composition and muscle performance during CrossFit© training. Twenty-nine subjects matched for training status (4.16 0.95 day/week) and body fat mass (12.66 4.08%) were randomly assigned to a betaine (BET; N = 14) or placebo group (PLA; N = 15). Body composition and cellular hydration were estimated with skinfolds measurement and bioelectrical impendence before and after 6 weeks of training. Muscle performance was assessed using three different tests: 3-RM back-squat for muscle strength, 2 km rowing test for aerobic capacity and Bergeron Beep Test for anaerobic capacity. Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups. Although not significant, fat mass was reduced in BET compared to PLA. Overall, body composition and cell hydration measurements did not change in response to training or betaine supplementation. Short-term (6 weeks) betaine supplementation supports muscle strength but was not ergogenic for trained subjects to aerobic and anaerobic performance in the CrossFit©-specific test.",2020,"Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups.",['Twenty-nine subjects matched for training status (4.16 0.95 day/week) and body fat mass (12.66 4.08'],"['placebo', 'betaine supplementation', 'Betaine Supplementation']","['Body composition and cellular hydration', 'Overall, body composition and cell hydration measurements', 'Muscle performance', 'Muscle Hypertrophy or Strength', 'body composition and muscle performance', 'fat mass', 'Muscle strength assessed during back squat significantly increased in BET']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}]",29.0,0.086445,"Muscle strength assessed during back squat significantly increased in BET (p = 0.04) but not in the PLA group, however, there were no statistical differences between groups.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Moro', 'Affiliation': 'Department of Biomedical Science, University of Padova, 35100 Padova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Badiali', 'Affiliation': 'iF srl Faenza, \u200e48100 Ravenna, Italy.'}, {'ForeName': 'Iader', 'Initials': 'I', 'LastName': 'Fabbri', 'Affiliation': 'iF srl Faenza, \u200e48100 Ravenna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Science, University of Padova, 35100 Padova, Italy.'}]",Nutrients,['10.3390/nu12061688'] 2633,32517117,Manipulating Self-Avatar Body Dimensions in Virtual Worlds to Complement an Internet-Delivered Intervention to Increase Physical Activity in Overweight Women.,"Virtual reality has been found to be a useful tool for positively influencing relevant psychological variables in order to increase physical activity (PA), especially in the overweight population. This study investigates the use of avatars and their physical variations to extend the effectiveness of existing interventions to promote PA. The main objective is to analyze the influence of the avatars' body dimensions on the efficacy of an Internet intervention to increase PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals). A total of 42 overweight women received a brief online intervention, and they were randomly assigned to one of three conditions: the ""Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC: participants are represented by avatars with participants' current body dimensions); and the ""Non avatar"" (NAC: participants are not represented by avatars). Results showed that the online intervention was effective in increasing PA practice and self-efficacy expectations. However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.",2020,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","['Overweight Women', '42 overweight women']","['Internet intervention', 'Non avatar"" (NAC', 'brief online intervention', 'Ideal avatar"" (IAC: participants are represented by avatars with ideal body dimensions); the ""Real avatar"" (RAC']","['PA practice and self-efficacy expectations', 'PA levels and improve other relevant variables (motivation toward PA, enjoyment, anxiety, self-efficacy, and PA goals']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0668624', 'cui_str': 'AKT1 protein, human'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",42.0,0.0140915,"However, manipulating the body dimensions of avatars did not improve this intervention, although ideal avatars helped to reduce the anxiety experienced during PA in this population.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de investigación e Innovación en Bioingenieria, Universitat Politécnica de Valencia, 46022 Valencia, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114045'] 2634,32517123,Lactobacillus rhamnosus GG (ATCC 53103) for the Management of Infantile Colic: A Randomized Controlled Trial.,"BACKGROUND The aim of this study was to investigate the efficacy of Lactobacillus rhamnosus ATCC 53103 together with the maternal diet avoidance of cow's milk in treating infantile colic. METHODS Forty-five colicky breastfed infants were consecutively randomized to receive L. rhamnosus for 28 days at a dosage of 5 × 10 9 cfu per day or placebo. Faecal samples were collected from each subject before starting supplementation and at the end of the study period and were immediately analysed. Faecal calprotectin was detected via a quantitative assay. The total bacterial load and selected bacterial species were evaluated using real-time TaqMan PCR. RESULTS After supplementation for 28 days with Lactobacillus rhamnosus ATCC 53103, median full-force daily crying was reduced (104 versus 242 min, p < 0.001) and the values of faecal calprotectin decreased significantly ( p = 0.026). Furthermore, the probiotic increased the abundance of Lactobacillus ( p = 0.048) and total bacteria ( p = 0.040); all these effects were not observed in the placebo group. CONCLUSION Infants treated with Lactobacillus rhamnosus ATCC 53103 for 28 days, in association with the elimination of cow's milk from the maternal diet, presented some interesting features related to the effect of this probiotic treatment: reductions in crying time and faecal calprotectin, with increased total bacteria and Lactobacillus. To validate these results, a double-blind, placebo-controlled trial on a larger cohort is required.",2020,"Furthermore, the probiotic increased the abundance of Lactobacillus ( p = 0.048) and total bacteria ( p = 0.040); all these effects were not observed in the placebo group. ","['Forty-five colicky breastfed infants', 'Infantile Colic']","['Lactobacillus rhamnosus', 'Lactobacillus rhamnosus GG (ATCC 53103', 'ATCC', 'Lactobacillus rhamnosus ATCC', 'placebo']","['total bacterial load and selected bacterial species', 'total bacteria', 'abundance of Lactobacillus', 'values of faecal calprotectin', 'crying time and faecal calprotectin', 'total bacteria and Lactobacillus', 'median full-force daily crying', 'Faecal calprotectin']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0857334', 'cui_str': 'Colicky sensation quality'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0266836', 'cui_str': 'Infantile colic'}]","[{'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",53103.0,0.178844,"Furthermore, the probiotic increased the abundance of Lactobacillus ( p = 0.048) and total bacteria ( p = 0.040); all these effects were not observed in the placebo group. ","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savino', 'Affiliation': 'Department of Pediatrics, S.S.D. Subintensive Neonatal Care, Children Hospital ""Regina Margherita"", A.U.O. Città della Salute e della Scienza di Torino, 10126 Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Montanari', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Galliano', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Daprà', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Bergallo', 'Affiliation': 'Dipartimento delle Scienze di Sanità Pubblica e Pediatriche, Università degli Studi di Torino, Scuola di Medicina, 10126 Torino, Italy.'}]",Nutrients,['10.3390/nu12061693'] 2635,32517165,When Do Good Deeds Lead to Good Feelings? Eudaimonic Orientation Moderates the Happiness Benefits of Prosocial Behavior.,"Engaging in prosocial behavior is considered an effective way to increase happiness in a sustainable manner. However, there is insufficient knowledge about the conditions under which such a happiness effect occurs. From a person-activity congruence perspective, we proposed that an individual's eudaimonic orientation moderates the effect of prosocial behavior on happiness, whereas hedonic orientation does not. For this purpose, 128 participants were assigned to play a game in which half of them were explained the benevolence impact of playing the game (the benevolence condition), and the other half played the same game without this knowledge (the control condition). Participants' eudaimonic and hedonic orientations were assessed before the game, and their post-task happiness were measured after the game. The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition. Furthermore, this happiness effect was moderated by participants' eudaimonic orientation-participants with high eudaimonic orientation reaped greater benefits from benevolence, and their hedonic orientation did not moderate the relationship between benevolence and happiness. The importance of the effect of person-activity congruence on happiness is discussed, along with the implications of these findings for sustainably pursuing happiness.",2020,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,['128 participants'],[],"['eudaimonic and hedonic orientations', 'higher post-task positive affect']",[],[],"[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",128.0,0.0317442,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,"[{'ForeName': 'Weipeng', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Qionghan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Hezhi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17114053'] 2636,32517188,Effect of the Fat Eaten at Breakfast on Lipid Metabolism: A Crossover Trial in Women with Cardiovascular Risk.,"Recent studies point out that not only the daily intake of energy and nutrients but the time of day when they are ingested notably regulates lipid metabolism and cardiovascular risk (CVR). Therefore, the aim of the study was to assess if the type of fat ingested at breakfast can modify lipid metabolism in women with CVR. A randomized, crossover clinical trial was performed. Sixty volunteers were randomly assigned to a (A) polyunsaturated fatty acid (PUFA)-rich breakfast, (B) saturated fatty acid (SFA)-rich breakfast, or (C) monounsaturated fatty acid (MUFA)-rich breakfast. Plasma lipoprotein and apolipoprotein subfractions were determined. Our data showed that the PUFA-rich breakfast decreased lipoprotein (a) (Lp(a)), very low-density lipoproteins (VLDL), and intermediate-density lipoproteins (IDL), and increased high-density lipoproteins (HDL). A similar trend was observed for the MUFA-rich breakfast, whereas the SFA-rich breakfast, although it decreased VLDL, also increased IDL and reduced HDL. The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B. In summary, varying the type of fat eaten at breakfast is enough to significantly modify the lipid metabolism of women with CVR, which can be of great relevance to establish new therapeutic strategies for the treatment of these subjects.",2020,The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B.,"['women with CVR', 'Sixty volunteers', 'Women with Cardiovascular Risk']","['Fat Eaten at Breakfast', 'polyunsaturated fatty acid (PUFA)-rich breakfast, (B) saturated fatty acid (SFA)-rich breakfast, or (C) monounsaturated fatty acid (MUFA)-rich breakfast']","['Lipid Metabolism', 'lipid metabolism and cardiovascular risk (CVR', 'lipid metabolism', 'Plasma lipoprotein and apolipoprotein subfractions', 'IDL and reduced HDL', 'PUFA-rich breakfast decreased lipoprotein (a) (Lp(a)), very low-density lipoproteins (VLDL), and intermediate-density lipoproteins (IDL), and increased high-density lipoproteins (HDL', 'β-lipoproteins and apolipoprotein-B']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0065063', 'cui_str': 'Intermediate density lipoprotein'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}]",60.0,0.0268842,The PUFA-rich breakfast also decreased β-lipoproteins and apolipoprotein-B.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Delgado-Alarcón', 'Affiliation': 'Health Science PhD program, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Hernández Morante', 'Affiliation': 'Eating Disorder Research Unit., Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Francisco V', 'Initials': 'FV', 'LastName': 'Aviles', 'Affiliation': 'Service of Biochemistry, Hospital Universitario Virgen de la Arrixaca, 30120 Murcia, Spain.'}, {'ForeName': 'María D', 'Initials': 'MD', 'LastName': 'Albaladejo-Otón', 'Affiliation': 'Service of Biochemistry, Hospital Universitario Santa Lucia of Cartagena, 30202 Murcia, Spain.'}, {'ForeName': 'Juana M', 'Initials': 'JM', 'LastName': 'Morillas-Ruíz', 'Affiliation': 'Food Technology and Nutrition Department, Catholic University of Murcia, 30107 Murcia, Spain.'}]",Nutrients,['10.3390/nu12061695'] 2637,32517192,Effect of Magnesium Supplementation on Circulating Biomarkers of Cardiovascular Disease.,"(1) Background: Magnesium supplementation may be effective for the prevention of cardiometabolic diseases, but the mechanisms are unclear. Proteomic approaches can assist in identifying the underlying mechanisms. (2) Methods: We collected repeated blood samples from 52 individuals enrolled in a double-blind trial which randomized participants 1:1 to oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo for 10 weeks. Plasma levels of 91 proteins were measured at baseline with follow-up samples using the Olink Cardiovascular Disease III proximity extension assay panel and were modeled as arbitrary units in a log 2 scale. We evaluated the effect of oral magnesium supplementation for changes in protein levels and the baseline association between serum magnesium and protein levels. The Holm procedure was used to adjust for multiple comparisons. (3) Results: Participants were 73% women, 94% white, and had a mean age of 62. Changes in proteins did not significantly differ between the two intervention groups after correction for multiple comparisons. The most statistically significant effects were on myoglobin [difference -0.319 log 2 units, 95% confidence interval (CI) (-0.550, -0.088), p = 0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045), p = 0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031), p = 0.019), ST2 protein (-0.198, (-0.363, -0.032), p = 0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015), p = 0.029). Similarly, none of the associations of baseline serum magnesium with protein levels were significant after correction for multiple comparisons. (4) Conclusions: Although we did not identify statistically significant effects of oral magnesium supplementation in this relatively small study, this study demonstrates the value of proteomic approaches for the investigation of mechanisms underlying the beneficial effects of magnesium supplementation. Clinical Trials Registration: ClinicalTrials.gov NCT02837328.",2020,"The most statistically significant effects were on myoglobin [difference -0.319 log 2 units, 95% confidence interval (CI) (-0.550, -0.088), p = 0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045), p = 0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031), p = 0.019), ST2 protein (-0.198, (-0.363, -0.032), p = 0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015), p = 0.029).","['Participants were 73% women, 94% white, and had a mean age of 62', '52 individuals enrolled']","['Magnesium Supplementation', 'oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo', 'oral magnesium supplementation', 'Magnesium supplementation']","['Plasma levels of 91 proteins', 'Circulating Biomarkers of Cardiovascular Disease', 'ST2 protein', 'tartrate-resistant acid phosphatase type']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",73.0,0.469746,"The most statistically significant effects were on myoglobin [difference -0.319 log 2 units, 95% confidence interval (CI) (-0.550, -0.088), p = 0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045), p = 0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031), p = 0.019), ST2 protein (-0.198, (-0.363, -0.032), p = 0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015), p = 0.029).","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Lin Y', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Faye L', 'Initials': 'FL', 'LastName': 'Norby', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Rooney', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}]",Nutrients,['10.3390/nu12061697'] 2638,32517390,Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial.,"BACKGROUND Hemiplegic shoulder pain is one of the most common complications after stroke. Although there are many treatment strategies for this complication, sometimes very resistant cases are also seen. OBJECTIVES To evaluate the effect of suprascapular nerve pulsed radiofrequency (PRF) treatment for hemiplegic shoulder pain (HSP). STUDY DESIGN A prospective randomized-controlled trial. SETTING University hospital. METHODS This study included 30 patients with HSP following stroke. The patients were randomly assigned to receive PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB group, n = 15). The patients were randomized into 2 groups (n = 15 both). In addition, the patients received physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise (5 days per week for 3 weeks in a total of 15 sessions). Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM) were assessed at baseline, 1 month, and 3 months after the procedure. RESULTS Between the groups, comparison revealed that decrease in the VAS score was statistically significantly higher at the first (3.5 1.9 vs. 1.2 1.0) and third month (4.2 1.7 vs. 1.2 0.9) in the PRF group compared with the NB group (P < 0.01). The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05). LIMITATION There is a need for further studies with a longer follow-up period. CONCLUSIONS In light of these findings, the combination of PRF applied to the suprascapular nerve and physical therapy was superior to the combination of suprascapular NB and physical therapy. KEY WORDS Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve.",2020,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05). ","['30 patients with HSP following stroke', 'Hemiplegic Shoulder Pain', 'hemiplegic shoulder pain (HSP', 'University hospital']","['physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise', 'Suprascapular Nerve Pulsed Radiofrequency Treatment', 'suprascapular nerve pulsed radiofrequency (PRF', 'PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB']","['VAS score', 'GAS score', 'shoulder ROM', 'Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM', 'Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C3179076', 'cui_str': 'Pulsed Radio Frequency Treatment'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}]",30.0,0.0551158,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05). ","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Alanbay', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kesan State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Berke', 'Initials': 'B', 'LastName': 'Aras', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kastamonu Rehabilitation Centre, Kastamonu, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Kesikburun', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Selvinaz', 'Initials': 'S', 'LastName': 'Kizilirmak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Gülhane Medical School, Gaziler Physical Therapy and Rehabilitation Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Yasar', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Arif Kenan', 'Initials': 'AK', 'LastName': 'Tan', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}]",Pain physician,[] 2639,32517391,Conservative Treatment Versus Ultrasound-Guided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial.,"BACKGROUND Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient. OBJECTIVES The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy. STUDY DESIGN A prospective, randomized, sham-controlled study. SETTING Health Sciences University Training and Research Hospital in Turkey. METHODS Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) US-guided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period. RESULTS A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05). LIMITATIONS The limitation of the study was a short follow-up period. CONCLUSIONS US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment. KEY WORDS Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation.",2020,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"['Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study', 'A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period', 'patients with neuropathic pain symptoms', 'Meralgia Paresthetica', 'Health Sciences University Training and Research Hospital in Turkey']","['transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy', 'ultrasound (US)-guided LFCN injection', 'conventional TENS', 'US-guided injection group, (2) TENS group, and (3) sham TENS', 'Conservative Treatment Versus Ultrasound-Guided Injection', 'Meralgia paresthetica (MP', 'LFCN injection and TENS', 'Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation']","['VAS, SF-36, and PSQI scores', 'SF-36 and PSQI scores', 'mean changes in painDETECT and SWMt scores', 'Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0394678', 'cui_str': 'Conventional transcutaneous electrical nerve stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",3.0,0.0400468,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Kiliç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gebze Fatih State Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Feyza Ünlü', 'Initials': 'FÜ', 'LastName': 'Özkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Duygu Geler', 'Initials': 'DG', 'LastName': 'Külcü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Haydarpasa Numune Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Öztürk', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Akpinar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Aktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}]",Pain physician,[] 2640,32517392,Clinical Study of Spinal Cord Stimulation and Pulsed Radiofrequency for Management of Herpes Zoster-Related Pain Persisting Beyond Acute Phase in Elderly Patients.,"BACKGROUND Postherpetic neuralgia (PHN) occurs in 9% to 34% of herpes zoster (HZ) patients, and the incidence of PHN is positively correlated with age. A number of patients suffer from poor therapeutic effects or intolerable side effects and need to accept minimally invasive analgesia. OBJECTIVES This study aimed to investigate the effects of spinal cord stimulation (SCS) and pulsed radiofrequency (PRF) on the treatment of elderly patients with HZ-related pain persisting beyond the acute phase. STUDY DESIGN A prospective, randomized-controlled trial. SETTING Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China). METHODS We selected 63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset. They were randomly divided into an SCS group and a PRF group. In the SCS group, the stimulus electrodes were placed in the affected spinal ganglion segment of the epidural space for 2 weeks. In the PRF group, the radiofrequency needle was percutaneously punctured in the affected dorsal root ganglion. The main outcome measures were the Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate. The secondary endpoint was defined as the use of analgesics and calcium channel antagonists. RESULTS The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) . The effective rate of pain management was in the range of 56.67% to 81.25%, and the complete pain relief rate ranged from 37% to 71%. The number of patients still using analgesics and calcium channel antagonists after operation were significantly less than those pre-operation (P < .001). Univariate and multivariate logistic regression analyses showed that the operation method, age, gender, and course of disease did not affect surgical efficacy. LIMITATIONS The main limitation of this study is that all the cases were from the same center. CONCLUSION It therefore can be concluded that SCS and PRF can effectively relieve PHN. KEY WORDS Spinal cord stimulation, pulsed radiofrequency, postherpetic neuralgia.",2020,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","['Elderly Patients', 'Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China', 'elderly patients with HZ-related pain persisting beyond the acute phase', '63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset']","['Spinal Cord Stimulation and Pulsed Radiofrequency', 'spinal cord stimulation (SCS) and pulsed radiofrequency (PRF', 'radiofrequency needle', 'SCS']","['Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate', 'complete pain relief rate', 'NRS-11 score', 'use of analgesics and calcium channel antagonists', 'effective rate of pain management']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",63.0,0.0296937,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","[{'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pain Medicine, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'Haining', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sima', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}]",Pain physician,[] 2641,32517393,Dexmedetomidine Added to Bupivacaine versus Bupivacaine in Transincisional Ultrasound-Guided Quadratus Lumborum Block in Open Renal Surgeries: A Randomized Trial.,"BACKGROUND General anesthesia (GA) is the preferred anesthetic modality for open renal surgeries to ensure a patent airway while the patient is in the lateral decubitus position. However, these surgeries are usually accompanied by severe postoperative pain with increased requirements for multimodal pain management strategies. Regional blocks provide better postoperative pain control with less systemic opioid consumption. OBJECTIVES The aim of this study was to describe the ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB) as a new approach, and to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine alone for TiQLB in combination with GA regarding postoperative analgesia and adverse effects in open renal surgery. STUDY DESIGN A prospective, randomized, double-blind, controlled trial. SETTING Ain Shams University Hospitals. METHODS Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status I to II were enrolled in the study. They were randomly allocated into 2 equal groups: group dexmedetomidine-bupivacaine (DB) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine (B) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% only. The primary outcome was the total morphine consumption among both groups, whereas the secondary outcomes were the Visual Analog Scale (VAS) scores and the time to first analgesic requirement during the first 24 hours. Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression, were also recorded. RESULTS Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001). Time to first analgesic requirement was prolonged in patients in the DB group (18.6 ± 2.4 hours) in comparison to patients in the B group (7.3 ± 1.1 hours). Ten minutes after the block there was a significant reduction in mean blood pressure and heart rate in the DB group than in the B group. Regarding postoperative adverse effects, sedation scores were higher in the DB group than in the B group, postoperative nausea, vomiting, and shivering were significantly higher in the B group than in the DB group. Bradycardia was significantly more frequent among the DB group. Although nonsignificant, pruritus was more frequent in the B group than in the DB group. No cases of respiratory depression were reported in both groups. LIMITATIONS The used technique US-guided TiQLB could be performed in open renal surgeries only. CONCLUSIONS The new approach US-guided TiQLB was effective and easy to be performed. Adding dexmedetomidine to bupivacaine in TiQLB was associated with potent and prolonged postoperative analgesia with fewer postoperative adverse effects. KEY WORDS Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine.",2020,"RESULTS Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","['Ain Shams University Hospitals', 'Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status', 'Open Renal Surgeries']","['Bupivacaine', 'bupivacaine', 'dexmedetomidine-bupivacaine (DB', 'combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine', 'Dexmedetomidine', 'General anesthesia (GA', 'ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB', 'dexmedetomidine', 'combined GA plus TiQLB']","['total morphine consumption and lower VAS scores', 'Bradycardia', 'Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression', 'Visual Analog Scale (VAS) scores and the time to first analgesic requirement', 'postoperative adverse effects, sedation scores', 'total morphine consumption', 'Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine', 'respiratory depression', 'Time to first analgesic requirement', 'postoperative nausea, vomiting, and shivering', 'mean blood pressure and heart rate', 'pruritus']","[{'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",80.0,0.0898718,"RESULTS Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","[{'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Marwa A K', 'Initials': 'MAK', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Pain physician,[] 2642,32517490,Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: a randomized controlled trial.,"OBJECTIVE To investigate the effectiveness and safety of Baduanjin training on the cognitive function in stroke survivors with cognitive impairment. DESIGN A randomized, two-arm parallel controlled trial with allocation concealment and assessors blinding. SETTING Community centre of Fuzhou city, China. SUBJECTS A total of 48 participants were recruited and randomly allocated into the Baduanjin exercise intervention or control group. INTERVENTIONS The control group maintained original medication and rehabilitation treatment. The Baduanjin training group received 24-week Baduanjin training with a frequency of three days a week and 40 minutes a day based on original medication and rehabilitation treatment. MAIN OUTCOME MEASURES The primary outcome was global cognitive function. Secondary outcome measures included the specific domains of cognition (i.e. memory, processing speed, execution, attention and visuospatial ability) and activities daily living. RESULTS In total, 41 (Baduanjin n  = 22, control n  = 19) participants completed 24-week treatment and data collection. Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: -42.4 (-75.0 to -9.8); TMT-B: -71.3 (-130.6 to -12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: -245.5 (-387 to -104)) and activities of daily living (modified Barthel Index). CONCLUSION Regular Baduanjin training is associated with less loss of cognitive function in patients after stroke.",2020,"Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: -42.4 (-75.0 to -9.8); TMT-B: -71.3 (-130.6 to -12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: -245.5 (-387 to -104)) and activities of daily living (modified Barthel Index). ","['A total of 48 participants', 'patients with post-stroke cognitive impairment', 'patients after stroke', 'stroke survivors with cognitive impairment', 'Community centre of Fuzhou city, China']","['Baduanjin training', 'control group maintained original medication and rehabilitation treatment', 'Regular Baduanjin training', 'Baduanjin exercise intervention or control group', 'Baduanjin exercise']","['activities of daily living (modified Barthel Index', 'global cognitive function', 'specific domains of cognition (i.e. memory, processing speed, execution, attention and visuospatial ability) and activities daily living', 'cognitive function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",48.0,0.0905076,"Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: -42.4 (-75.0 to -9.8); TMT-B: -71.3 (-130.6 to -12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: -245.5 (-387 to -104)) and activities of daily living (modified Barthel Index). ","[{'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zheng', 'Affiliation': 'College of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, China.'}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Xiong', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Bingzhao', 'Initials': 'B', 'LastName': 'Ye', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}]",Clinical rehabilitation,['10.1177/0269215520930256'] 2643,32517492,Intraoperative Effect of 2D vs 3D Fluoroscopy on Quality of Reduction and Patient-Related Outcome in Calcaneal Fracture Surgery.,"BACKGROUND Three-dimensional (3D) fluoroscopy is thought to be advantageous in the open reduction and internal fixation (ORIF) of calcaneal fractures. The goal of this multicenter randomized controlled trial was to investigate the clinical effect of additional intraoperative 3D fluoroscopy on postoperative quality of reduction and fixation and patient-reported outcome as compared to conventional 2-dimensional (2D) fluoroscopy in patients with intra-articular fractures of the calcaneus. METHODS Patients were randomized to 3D or conventional 2D fluoroscopy during operative treatment of calcaneal fractures. Primary outcome was the difference in quality of fracture reduction and implant position on postoperative computed tomography (CT). Secondary endpoints included intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure). Function and patient-reported outcome were evaluated after surgery and included range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification. A total of 102 calcaneal fractures were included in the study in 100 patients. Fifty fractures were randomized to the 3D group and 52 to the 2D group. RESULTS There was a statistically significant difference in duration of surgery between the groups (2D 125 min vs 3D 147 min; P < .001). After 3D fluoroscopy, a total of 57 intraoperative corrections were performed in 28 patients (56%). The postoperative CT scan revealed an indication for additional revision of reduction or implant position in 69% of the 3D group vs 60% in the 2D fluoroscopy group. At 2 years, there was no difference in number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis. CONCLUSION The use of intraoperative 3D fluoroscopy in the treatment of intra-articular calcaneal fractures prolongs the operative procedures without improving the quality of reduction and fixation. There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. Level of Evidence: Level I, prospective randomized controlled study.",2020,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. ","['patients with intra-articular fractures of the calcaneus', 'Calcaneal Fracture Surgery', '102 calcaneal fractures were included in the study in 100 patients', 'Fifty fractures were randomized to the 3D group and 52 to the 2D group', 'Patients']","['conventional 2-dimensional (2D) fluoroscopy', 'conventional 2D fluoroscopy', 'intraoperative 3D fluoroscopy', '2D vs 3D Fluoroscopy', 'additional intraoperative 3D fluoroscopy']","['postoperative CT scan', 'number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis', 'postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis', 'additional revision of reduction or implant position', 'duration of surgery', 'quality of fracture reduction and implant position on postoperative computed tomography (CT', 'quality of reduction and fixation', 'range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification', 'intraoperative 3D fluoroscopy', 'Quality of Reduction and Patient-Related Outcome', 'intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332715', 'cui_str': 'Fracture, intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",50.0,0.0919927,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. ","[{'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Halm', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'M Suzan H', 'Initials': 'MSH', 'LastName': 'Beerekamp', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'de Muinck-Keijzer', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}]",Foot & ankle international,['10.1177/1071100720926111'] 2644,32517497,Icare versus Goldmann in a randomised middle-aged population: The influence of central corneal thickness and refractive errors.,"PURPOSE The aim of this study was to compare the measurements of intraocular pressure by two tonometers, the Icare rebound tonometer and the Goldmann applanation tonometer, in a randomised screening study. The influence of refraction and central corneal thickness on the measurements was also evaluated. METHODS Intraocular pressure was measured with rebound tonometer and Goldmann applanation tonometer in 1266 participants; refraction and central corneal thickness were also determined. One randomised eye of each participant was selected for this report's analysis. A Bland-Altman plot was used to compare the values obtained with the two devices. RESULTS The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 ( p  < 0.001). The mean difference (rebound tonometer-Goldmann applanation tonometer) was 0.11 ± 2.3 mmHg. The difference was not statistically significant (95% confidence interval: 0.11 to 0.13, p  = 0.09). With increasing central corneal thickness, not only did intraocular pressure values with both devices increase, but the difference between them also increased. Refraction (spherical equivalent) did not influence intraocular pressure or the rebound tonometer-Goldmann applanation tonometer difference. However, high astigmatism (≥2D) exerted an influence on intraocular pressure values taken with Goldmann applanation tonometer. CONCLUSION Measurements with rebound tonometer and Goldmann applanation tonometer are relatively uniform although rebound tonometer slightly overestimated intraocular pressure. Both rebound tonometer and Goldmann applanation tonometer and the difference between these devices were affected by central corneal thickness but not by refraction. Higher astigmatism affected Goldmann applanation tonometer more than rebound tonometer. It is concluded that rebound tonometer is a reliable method for measuring intraocular pressure in a population-based screening study.",2020,The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 (,['1266 participants'],"['Icare versus Goldmann', 'Icare rebound tonometer and the Goldmann applanation tonometer', 'rebound tonometer and Goldmann applanation tonometer']","['Goldmann applanation tonometer', 'intraocular pressure or the rebound tonometer-Goldmann applanation tonometer difference', 'mean difference (rebound tonometer-Goldmann applanation tonometer', 'intraocular pressure values', 'rebound tonometer and Goldmann applanation tonometer', 'intraocular pressure', 'central corneal thickness', 'refraction and central corneal thickness']",[],"[{'cui': 'C0183969', 'cui_str': 'Tonometer'}, {'cui': 'C1271528', 'cui_str': 'Goldmann applanation tonometer'}]","[{'cui': 'C1271528', 'cui_str': 'Goldmann applanation tonometer'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0183969', 'cui_str': 'Tonometer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",1266.0,0.0730484,The correlation between rebound tonometer and Goldmann applanation tonometer was good: the intraclass correlation coefficient (r) between the two methods was 0.735 (,"[{'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Stoor', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Karvonen', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'M Johanna', 'Initials': 'MJ', 'LastName': 'Liinamaa', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Saarela', 'Affiliation': 'Department of Ophthalmology, Oulu University Hospital, Oulu, Finland.'}]",European journal of ophthalmology,['10.1177/1120672120921380'] 2645,32517498,"Comparison of efficacy of a supervised versus non-supervised physical therapy exercise program on the pain, functionality and quality of life of patients with non-specific chronic low-back pain: a randomized controlled trial.","OBJECTIVE To compare the effectiveness of supervised physical therapy program versus non-supervised on pain, functionality, fear of movement and quality of life in patients with non-specific chronic low back pain. DESIGN A randomized double-blind clinical trial. SETTING Clinical outpatient unit; home. SUBJECTS A total of 64 participants with non-specific chronic low back pain were randomized into either supervised exercise group ( n  = 32) or non-supervised home exercise group ( n  = 32). INTERVENTIONS The supervised group was treated with therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home. Both groups received three weekly sessions for eight weeks. MAIN MEASURES Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion were assessed at baseline, two, and six months of follow-up. RESULTS Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. CONCLUSION Patients with chronic low back pain who received supervised exercise showed more improvement in both the short and long term in all patient-rated outcomes over the non-supervised group, but the differences were small and not clinically significant.",2020,"Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. ","['patients with non-specific chronic low back pain', '64 participants with non-specific chronic low back pain', 'patients with non-specific chronic low-back pain']","['supervised exercise', 'supervised exercise group ( n \u2009=\u200932) or non-supervised home exercise group', 'supervised versus non-supervised physical therapy exercise program', 'supervised physical therapy program versus non-supervised', 'therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home']","['pain, functionality and quality of life', 'disability for Roland-Morris Disability Questionnaire', 'Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion', 'pain', 'patient-rated pain, functionality, fear of movement and quality of life', 'Oswestry Disability Index', 'pain, functionality, fear of movement and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0333043', 'cui_str': 'Anterior displacement'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",64.0,0.0799912,"Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. ","[{'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Matarán-Peñarrocha', 'Affiliation': 'Andalusian Health Service, Family Medicine and Primary Care, Distrito Sanitario Málaga, Granada, Spain.'}, {'ForeName': 'Inmaculada Carmen', 'Initials': 'IC', 'LastName': 'Lara Palomo', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Antequera Soler', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Gil-Martínez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Adelaida María', 'Initials': 'AM', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520927076'] 2646,31256633,Feasibility of a Lifestyle Physical Activity Intervention to Prevent Memory Loss in Older Women With Cardiovascular Disease: A Mixed-Methods Approach.,"BACKGROUND Memory loss in older age affects women more than men and cardiovascular disease is a leading risk factor. Physical activity can improve memory in healthy older adults; however, few physical activity interventions have targeted women with cardiovascular disease, and none utilized lifestyle approaches. PURPOSE The purpose of this study was to examine feasibility, acceptability, and preliminary effects of a 24-week lifestyle physical activity intervention (physical activity prescription, five group meetings, and nine motivational interviewing calls). METHODS A sequential mixed-methods approach was used. Participants were 18 sedentary women ≥65 years with cardiovascular disease and without cognitive impairment recruited in August 2017. Feasibility, acceptability, self-reported health, accelerometer-assessed physical activity, and neurocognitive memory tests were measured using a pre-post test design. Two post-intervention focus groups ( n  = 8) were conducted in June 2018. Concept analysis was used to identify barriers/motivators of intervention participation. RESULTS Meeting attendance was >72% and retention was 94%. Participants rated the program with high satisfaction. There were significant improvements at 24 weeks in self-rated physical health, objective daily steps, and estimated cardiorespiratory fitness ( d  = .30-.64). Focus group themes generated recommendations for modifying the intervention. CONCLUSION Findings support adapting the intervention further for women with cardiovascular disease and testing it in an efficacy trial.",2019,"There were significant improvements at 24 weeks in self-rated physical health, objective daily steps, and estimated cardiorespiratory fitness ( d  = .30-.64).","['Participants were 18 sedentary women ≥65 years with cardiovascular disease and without cognitive impairment recruited in August 2017', 'women with cardiovascular disease', 'healthy older adults', 'Older Women With Cardiovascular Disease']","['Lifestyle Physical Activity Intervention', 'Physical activity', '24-week lifestyle physical activity intervention (physical activity prescription, five group meetings, and nine motivational interviewing calls']","['self-rated physical health, objective daily steps, and estimated cardiorespiratory fitness', 'Feasibility, acceptability, self-reported health, accelerometer-assessed physical activity, and neurocognitive memory tests', 'Memory Loss']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}]",18.0,0.0834212,"There were significant improvements at 24 weeks in self-rated physical health, objective daily steps, and estimated cardiorespiratory fitness ( d  = .30-.64).","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Halloway', 'Affiliation': 'Department of Community, Systems and Mental Health Nursing, Rush University, Chicago, IL, USA.'}, {'ForeName': 'JoEllen', 'Initials': 'J', 'LastName': 'Wilbur', 'Affiliation': 'Department of Women, Children and Family Nursing, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Schoeny', 'Affiliation': 'Department of Community, Systems and Mental Health Nursing, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Lynne T', 'Initials': 'LT', 'LastName': 'Braun', 'Affiliation': 'Department of Adult Health and Gerontological Nursing, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Neelum T', 'Initials': 'NT', 'LastName': 'Aggarwal', 'Affiliation': ""Department of Neurological Sciences, Rush Medical College; Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.""}, {'ForeName': 'Arlene M', 'Initials': 'AM', 'LastName': 'Miller', 'Affiliation': 'Department of Community, Systems and Mental Health Nursing, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Crane', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Annabelle S', 'Initials': 'AS', 'LastName': 'Volgman', 'Affiliation': 'Department of Internal Medicine, Rush Medical College; Rush Heart Center for Women, Rush University Medical Center, Chicago, IL, USA.'}]",The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres,['10.1177/0844562119856233'] 2647,31299912,A community-based intervention to increase participation in cervical cancer screening among immigrants in Norway.,"BACKGROUND The attendance to cervical cancer screening is low among immigrants in many high-income countries. Although several interventions have been experimentally tested,implementation remains a challenge. Several factors are an impediment, including the lack of methodological descriptions of the development and implementation of such interventions. In this paper,we present in detail the development, methodological challenges and practical implementation of a community based intervention aimed to increase the participation of immigrant women in cervical cancer screening in Norway. METHODS This study was initially designed as a cluster randomized trial to be carried out in four geographical areas near Oslo between Feb-October 2017. Participants were immigrant women aged 25-69 years from Pakistan and Somalia. This paper describes the theoretical background for the development of the intervention,followed by challenges,the changes in the original design and solutions adopted related to the study design,recruitment and implementation of the intervention. The intervention was developed based on two theoretical frameworks, the Ecological and the Heron's six categories intervention framework. An oral 20-25 min presentation in the language of participants encompassing topics of cervical cancer and screening was given according to the needs detected in focus groups conducted at the beginning of the study,followed by an opportunity to raise questions and answering a short questionnaire. RESULTS Contrary to the initial study design, this had to be converted into a non-randomised trial due to the difficulties associated with randomization of immigrant families who are finely scattered in heavily populated towns and a high risk of contamination. We therefore adopted a pragmatic approach and recruited women in the intervention areas through a variety of channels and institutions. Neighboring areas were considered to be non-randomised controls. Female researchers with Pakistani and Somali background invited as many women as possible in the intervention areas. Among the women who were invited to participate,42% of the Pakistani and 78% of Somali attended the meetings. CONCLUSION Despite the careful development of a culturally adapted health intervention in collaboration with the community; randomization and recruitment of immigrants for community trials remains challenging. Nevertheless, sharing strategies to overcome specific challenges related to promoting health interventions for immigrants, can be of potential help to scale-up interventions and for building new research projects. TRIAL REGISTRATION NCT03155581 . Retrospectively registered, on 16 May 2017.",2019,"Contrary to the initial study design, this had to be converted into a non-randomised trial due to the difficulties associated with randomization of immigrant families who are finely scattered in heavily populated towns and a high risk of contamination.","['Participants were immigrant women aged 25-69\u2009years from Pakistan and Somalia', 'cervical cancer screening among immigrants in Norway', 'women who were invited to participate,42% of the Pakistani and 78% of Somali attended the meetings', 'four geographical areas near Oslo between Feb-October 2017', 'immigrant women in cervical cancer screening in Norway']",[],[],"[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0337847', 'cui_str': 'Somalis'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}]",[],[],,0.0358667,"Contrary to the initial study design, this had to be converted into a non-randomised trial due to the difficulties associated with randomization of immigrant families who are finely scattered in heavily populated towns and a high risk of contamination.","[{'ForeName': 'Samera A', 'Initials': 'SA', 'LastName': 'Qureshi', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway. sameraazeem.qureshi@fhi.no.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Gele', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Prabhjot', 'Initials': 'P', 'LastName': 'Kour', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Kathy A', 'Initials': 'KA', 'LastName': 'Møen', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Norwegian Centre for Migrant & Minority Health (NAKMI), Norwegian Institute of Public Health (NIPH), P.O.Box 222 Skøyen, 0213, Oslo, Norway.'}]",BMC medical research methodology,['10.1186/s12874-019-0795-8'] 2648,31345172,Using joint models to disentangle intervention effect types and baseline confounding: an application within an intervention study in prodromal Alzheimer's disease with Fortasyn Connect.,"BACKGROUND Many prodromal Alzheimer's disease trials collect two types of data: the time until clinical diagnosis of dementia and longitudinal patient information. These data are often analysed separately, although they are strongly associated. By combining the longitudinal and survival data into a single statistical model, joint models can account for the dependencies between the two types of data. METHODS We illustrate the major steps in a joint modelling approach, motivated by data from a prodromal Alzheimer's disease study: the LipiDiDiet trial. RESULTS By using joint models we are able to disentangle baseline confounding from the intervention effect and moreover, to investigate the association between longitudinal patient information and the time until clinical dementia diagnosis. CONCLUSIONS Joint models provide a valuable tool in the statistical analysis of clinical studies with longitudinal and survival data, such as in prodromal Alzheimer's disease trials, and have several added values compared to separate analyses.",2019,"RESULTS By using joint models","[""prodromal Alzheimer's disease with Fortasyn Connect""]",[],[],"[{'cui': 'C3805054', 'cui_str': ""Prodromal Alzheimer's disease""}, {'cui': 'C4309713', 'cui_str': 'Fortasyn Connect'}]",[],[],,0.0549832,"RESULTS By using joint models","[{'ForeName': 'Floor M', 'Initials': 'FM', 'LastName': 'van Oudenhoven', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Sophie H N', 'Initials': 'SHN', 'LastName': 'Swinkels', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hartmann', 'Affiliation': 'German Institute for Dementia Prevention (DIDP), Saarland University, Homburg, Germany.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Anneke M J', 'Initials': 'AMJ', 'LastName': 'van Hees', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Rizopoulos', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands.'}]",BMC medical research methodology,['10.1186/s12874-019-0791-z'] 2649,31351084,Influence of desensitizing and anti-erosive toothpastes on dentine permeability: An in vitro study.,"OBJECTIVE This study analyzed the effect of desensitizing and/or anti-erosive toothpastes on dentine permeability. METHODS One-mm dentin discs were prepared from human molars and exposed to EDTA solution (5 min, 17%). Initial dentine permeability was measured, under constant pressure. Specimens were randomly allocated into 10 groups: four anti-erosive toothpastes (calcium silicate + sodium phosphate, potassium nitrate, stannous chloride + chitosan, oligopeptide-104); four desensitizing toothpastes (arginine + calcium carbonate, calcium sodium phosphosilicate, strontium acetate, stannous fluoride); and two controls (regular fluoridated toothpaste, and human saliva). They were submitted to a 5-day erosion-abrasion cycling model. Erosion consisted of immersion in citric acid (2 min, 0.3%, natural pH ˜ 2.6, 4x/day), followed by 1 h exposure to human saliva. Specimens were brushed for 15 s (2 N, 45 strokes) with the toothpaste slurries (total exposure time of 2 min). After 5 cycles, the final dentine permeability was determined. Dentine permeability change was calculated as a percentage of the initial hydraulic conductance (%Lp). Data were analyzed with one-way ANOVA and Tukey tests (α=0.05). RESULTS The toothpastes calcium silicate + sodium phosphate and potassium nitrate, showed significant decrease in %Lp, with no difference between them. The regular fluoridated toothpaste also decreased the %Lp, not differing from potassium nitrate. No desensitizing toothpaste showed change in %Lp. Human saliva, oligopeptide-104 and stannous chloride + chitosan presented significant increase in %Lp, without difference between them. CONCLUSION Calcium silicate + sodium phosphate, potassium nitrate, and the regular fluoridated toothpaste decreased dentine permeability, whereas the desensitizing toothpastes tested did not. CLINICAL RELEVANCE Toothpastes had distinct impacts on dentine permeability, which may reflect a variable effect on the treatment of dentine hypersensitivity. Within the limitations of a laboratory-based study, toothpastes with an anti-erosive claim could also be effective in reducing the pain in dentine hypersensitivity.",2019,"The toothpastes calcium silicate + sodium phosphate and potassium nitrate, showed significant decrease in %Lp, with no difference between them.",['One-mm dentin discs were prepared from human molars and exposed to'],"['Calcium silicate\u2009+\u2009sodium phosphate, potassium nitrate', 'desensitizing toothpaste', 'desensitizing and anti-erosive toothpastes', 'anti-erosive toothpastes (calcium silicate\u2009+\u2009sodium phosphate, potassium nitrate, stannous chloride\u2009+\u2009chitosan, oligopeptide-104); four desensitizing toothpastes (arginine\u2009+\u2009calcium carbonate, calcium sodium phosphosilicate, strontium acetate, stannous fluoride); and two controls (regular fluoridated toothpaste, and human saliva', 'immersion in citric acid', 'EDTA solution', 'desensitizing and/or anti-erosive toothpastes']","['dentine permeability', 'final dentine permeability', 'Dentine permeability change', 'Initial dentine permeability']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0028954', 'cui_str': 'Oligopeptides'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0540547', 'cui_str': 'strontium acetate'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",45.0,0.0182529,"The toothpastes calcium silicate + sodium phosphate and potassium nitrate, showed significant decrease in %Lp, with no difference between them.","[{'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'João-Souza', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo, Av. Prof. Lineu Prestes 2227, Cidade Universitária, São Paulo, Brazil. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo, Av. Prof. Lineu Prestes 2227, Cidade Universitária, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bühler Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University - UNESP, Av. Eng. Francisco José Longo 777, São José dos Campos, Brazil. Electronic address: alessandra@ict.unesp.br.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lussi', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7, Bern, Switzerland. Electronic address: adrian.lussi@zmk.unibe.ch.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Saads Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7, Bern, Switzerland. Electronic address: thiago.saads@zmk.unibe.ch.'}, {'ForeName': 'Ana Cecília', 'Initials': 'AC', 'LastName': 'Corrêa Aranha', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo, Av. Prof. Lineu Prestes 2227, Cidade Universitária, São Paulo, Brazil. Electronic address: acca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2019.07.014'] 2650,30782974,Role of Human Ventromedial Prefrontal Cortex in Learning and Recall of Enhanced Extinction.,"Standard fear extinction relies on the ventromedial prefrontal cortex (vmPFC) to form a new memory given the omission of threat. Using fMRI in humans, we investigated whether replacing threat with novel neutral outcomes (instead of just omitting threat) facilitates extinction by engaging the vmPFC more effectively than standard extinction. Computational modeling of associability (indexing surprise strength and dynamically modulating learning rates) characterized skin conductance responses and vmPFC activity during novelty-facilitated but not standard extinction. Subjects who showed faster within-session updating of associability during novelty-facilitated extinction also expressed better extinction retention the next day, as expressed through skin conductance responses. Finally, separable patterns of connectivity between the amygdala and ventral versus dorsal mPFC characterized retrieval of novelty-facilitated versus standard extinction memories, respectively. These results indicate that replacing threat with novel outcomes stimulates vmPFC involvement on extinction trials, leading to a more durable long-term extinction memory. SIGNIFICANCE STATEMENT Psychiatric disorders characterized be excessive fear are a major public health concern. Popular clinical treatments, such as exposure therapy, are informed by principles of Pavlovian extinction. Thus, there is motivation to optimize extinction strategies in the laboratory so as to ultimately develop more effective clinical treatments. Here, we used functional neuroimaging in humans and found that replacing (rather than just omitting) expected aversive events with novel and neutral outcomes engages the ventromedial prefrontal cortex during extinction learning. Enhanced extinction also diminished activity in threat-related networks (e.g., the insula, thalamus) during immediate extinction and a 24 h extinction retention test. This is new evidence for how behavioral protocols designed to enhance extinction affects neurocircuitry underlying the learning and retention of extinction memories.",2019,"Enhanced extinction also diminished activity in threat-related networks (e.g., the insula, thalamus) during immediate extinction and a 24 h extinction retention test.",[],[],[],[],[],[],,0.0186073,"Enhanced extinction also diminished activity in threat-related networks (e.g., the insula, thalamus) during immediate extinction and a 24 h extinction retention test.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'Department of Psychiatry, University of Texas at Austin, Austin, Texas 78712, joseph.dunsmoor@austin.utexas.edu.'}, {'ForeName': 'Marijn C W', 'Initials': 'MCW', 'LastName': 'Kroes', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behaviour and Mental Health, Peking University, Beijing, China.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Daw', 'Affiliation': 'Princeton Neuroscience Institute and Department of Psychology, Peking University, Princeton, New Jersey 08544.'}, {'ForeName': 'Helen B', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York 10032.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Phelps', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts 02138.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2713-18.2019'] 2651,32528374,Online Simulation Training of Child Sexual Abuse Interviews With Feedback Improves Interview Quality in Japanese University Students.,"Although previous research has confirmed the effectiveness of simulated child sexual abuse interviews with feedback, its validation is limited to Western contexts and face-to-face settings. The present study aims to extend this research to non-Western and online/remote training conditions. Thirty-two Japanese undergraduate students were randomly assigned to a control or feedback group. The feedback group conducted a set of six online simulated child sexual abuse interviews while receiving feedback after each interview in an attempt to improve the quality of their questioning style. The feedback consisted of the outcome of the alleged cases and the quality of the questions asked in the interviews. The control group conducted the interviews without feedback. The feedback (vs. control) increased the proportion of recommended questions (first interview: 45%; last interview: 65% vs. first: 43%; last: 42%, respectively) by using fewer not-recommended questions and eliciting fewer incorrect details. Furthermore, only participants in the feedback group (7 out of 17) demonstrated a reliable change in the proportion of recommended questions. The present study explores the efficacy of simulated interview training with avatars in a different cultural setting and in the context of remote administration. The differences between the present study and previous research are discussed in light of cultural and logistical aspects.",2020,"Furthermore, only participants in the feedback group (7 out of 17) demonstrated a reliable change in the proportion of recommended questions.","['Japanese University Students', 'Thirty-two Japanese undergraduate students', 'Child Sexual Abuse Interviews']","['control or feedback group', 'simulated interview training']","['Interview Quality', 'proportion of recommended questions']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0117674,"Furthermore, only participants in the feedback group (7 out of 17) demonstrated a reliable change in the proportion of recommended questions.","[{'ForeName': 'Shumpei', 'Initials': 'S', 'LastName': 'Haginoya', 'Affiliation': 'Faculty of Arts and Sciences, New York University (NYU) Shanghai, Shanghai, China.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Faculty of Arts, Psychology, and Theology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pompedda', 'Affiliation': 'School of Natural & Social Sciences, University of Gloucestershire, Cheltenham, United Kingdom.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Naka', 'Affiliation': 'Department of Comprehensive Psychology, Ritsumeikan University, Kyoto, Japan.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Antfolk', 'Affiliation': 'Faculty of Arts, Psychology, and Theology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Santtila', 'Affiliation': 'Faculty of Arts and Sciences, New York University (NYU) Shanghai, Shanghai, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00998'] 2652,32528389,Dog-Assisted Therapy for Children and Adolescents With Fetal Alcohol Spectrum Disorders a Randomized Controlled Pilot Study.,"Objective The rationale of this study was to evaluate the efficacy of dog-assisted therapy (DAT) combined with pharmacological treatment in children and adolescents with fetal alcohol spectrum disorder (FASD). Method We conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants were randomly assigned either to DAT group ( n = 17) or Treatment as Usual (TAU control group) ( n = 16). Results Of the initial 39 participants enrolled, 33 completed treatment. A mixed-effects model analysis revealed that participants who were assigned to the DAT group experienced significantly improvements on social skills (SSIS-P social skills: p = 0.02, d = 0.8), reductions on externalizing symptoms (CBCL externalizing: p = 0.03; d = 0.56), and lower scores on FASD severity (CGI-S clinician: p = 0.001, d = 0.5). Conclusion DAT is a promising adjunctive treatment for children and adolescents with FASD. Clinical Trial Registration Dog-assisted therapy for children and adolescents with fetal alcohol spectrum disorders: a randomized controlled pilot study; http://clinicaltrials.gov/, identifier NCT04038164.",2020,"A mixed-effects model analysis revealed that participants who were assigned to the DAT group experienced significantly improvements on social skills (SSIS-P social skills: p = 0.02, d = 0.8), reductions on externalizing symptoms (CBCL externalizing: p = 0.03; d = 0.56), and lower scores on FASD severity (CGI-S clinician: p = 0.001, d = 0.5). ","['Children and Adolescents With Fetal Alcohol Spectrum Disorders', 'children and adolescents with fetal alcohol spectrum disorder (FASD', '33 children and adolescents with FASD', 'children and adolescents with FASD', '39 participants enrolled, 33 completed treatment', 'children and adolescents with fetal alcohol spectrum disorders']","['DAT', 'Dog-Assisted Therapy', 'dog-assisted therapy (DAT) combined with pharmacological treatment', 'Usual (TAU control group', 'Dog-assisted therapy']","['FASD severity', 'externalizing symptoms', 'social skills (SSIS-P social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]",33.0,0.111525,"A mixed-effects model analysis revealed that participants who were assigned to the DAT group experienced significantly improvements on social skills (SSIS-P social skills: p = 0.02, d = 0.8), reductions on externalizing symptoms (CBCL externalizing: p = 0.03; d = 0.56), and lower scores on FASD severity (CGI-S clinician: p = 0.001, d = 0.5). ","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Vidal', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vidal', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Ristol', 'Affiliation': 'Centre de Terapia Assistida amb Cans, Barcelona, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Domènec', 'Affiliation': 'Centre de Terapia Assistida amb Cans, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Segú', 'Affiliation': 'Fundación Probitas, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vico', 'Affiliation': 'Fundación Probitas, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Gomez-Barros', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Josep Antoni', 'Initials': 'JA', 'LastName': 'Ramos-Quiroga', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",Frontiers in psychology,['10.3389/fpsyg.2020.01080'] 2653,32528390,"""Are You Telling the Truth?"" - Testing Individuals' Ability to Differentiate Between Truth and Deceit in Soccer.","In the present paper, we tested the ability of individuals to judge correctly whether athletes are lying or telling the truth. For this purpose, we first generated 28 videos as stimulus material: in half of the videos, soccer players were telling the truth, while in the other half, the same soccer players were lying. Next, we tested the validity of these video clips by asking N = 65 individuals in a laboratory experiment (Study 1a) and N = 52 individuals in an online experiment (Study 1b) to rate the level of veracity of each video clip. Results suggest that participants can distinguish between true and false statements, but only for some clips and not for others, indicating that some players were better at deceiving than others. In Study 2, participants again had to make veracity estimations, but we manipulated the level of information given, as participants ( N = 145) were randomly assigned to one of three conditions (regular video clips, mute video clips, and only the audio stream of each statement). The results revealed that participants from the mute condition were less accurate in their veracity ratings. The theoretical and practical implications of these findings are discussed.",2020,The results revealed that participants from the mute condition were less accurate in their veracity ratings.,"['participants again had to make veracity estimations, but we manipulated the level of information given, as participants ( N = 145', '65 individuals in a laboratory experiment (Study 1a) and N = 52 individuals in an online experiment (Study 1b) to rate the level of veracity of each video clip', '28 videos as stimulus material: in half of the videos, soccer players were telling the truth, while in the other half, the same soccer players were lying', 'Soccer']",[],['veracity ratings'],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]",[],[],145.0,0.0316056,The results revealed that participants from the mute condition were less accurate in their veracity ratings.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Englert', 'Affiliation': 'Institute of Sports Sciences, Department of Sports Psychology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Schweizer', 'Affiliation': 'Institute of Sports Sciences, Department of Sports Psychology, Heidelberg University, Heidelberg, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01082'] 2654,32517660,The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial.,"BACKGROUND The rate of multiple pregnancies in IVF/ICSI ranges from 20 to 30%. The incidence of preterm birth in multiple pregnancies is as high as 60% and is even higher in pregnancies conceived after IVF & ICSI. The effect of progesterone on prevention of preterm birth in twins is controversial. Our group has proven a positive effect in reduction of preterm birth, by starting progesterone from the mid-trimester, in exclusively IVF/ICSI singleton pregnancies but not twins. The purpose of our current study was to explore the effect of earlier administration of natural progesterone, in IVF/ICSI twin pregnancies starting at 11-14 weeks for prevention of preterm birth. METHODS This is a double-blind, placebo controlled, single center, randomized clinical trial. Women with dichorionic twin gestations, having an IVF/ICSI trial were randomized to receive natural rectal progesterone (800 mg daily) vs placebo, starting early from 11 to 14 weeks. They also received oral and vaginal antimicrobial agents as part of our routine treatment for vaginitis and urinary tract infection. They were randomized regardless of cervical length and had no previous history of preterm birth or known Mullerian anomalies. The primary outcome was spontaneous preterm birth rate before 37 weeks. The secondary outcome was; spontaneous preterm birth before 34, 32, 28 weeks and neonatal outcome. RESULTS A total of 203 women were randomized to both groups, final analysis included 199 women as 4 were lost to follow up. The base line characteristics as well as gestational age at delivery were not significantly different between the study and the placebo group (34.7 ± 3.6 vs 34.5 ± 4.5, P = 0.626). Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks. CONCLUSIONS Rectal natural progesterone starting from the first trimester in IVF/ICSI twin pregnancies did not reduce spontaneous preterm birth. TRIAL REGISTRATION The trial was registered on 31 January 2014 at www.ISRCTN.com, number 69810120.",2020,"Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks. ","['IVF/ICSI twin pregnancies starting at 11-14\u2009weeks for prevention of preterm birth', 'A total of 203 women were randomized to both groups, final analysis included 199 women as 4 were lost to follow up', 'IVF/ICSI twin pregnancies on the preterm birth rate', 'Women with dichorionic twin gestations, having an IVF/ICSI trial', '31 January 2014 at www']","['IVF/ICSI', 'natural rectal progesterone', 'natural progesterone', 'progesterone', 'Progesterone', 'oral and vaginal antimicrobial agents', 'rectal progesterone', 'placebo']","['spontaneous preterm birth rates', 'spontaneous preterm birth rate', 'spontaneous preterm birth', 'preterm birth', 'neonatal outcome']","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1136254', 'cui_str': 'Antimicrobial-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",203.0,0.81216,"Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks. ","[{'ForeName': 'Mona Mohamed', 'Initials': 'MM', 'LastName': 'Aboulghar', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Monaaboulghar71@gmail.com.'}, {'ForeName': 'Yahia', 'Initials': 'Y', 'LastName': 'El-Faissal', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Kamel', 'Affiliation': 'Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Serour', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Aboulghar', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.'}, {'ForeName': 'Yomna', 'Initials': 'Y', 'LastName': 'Islam', 'Affiliation': 'The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03033-4'] 2655,32517663,Adjuvant VACcination against HPV in surgical treatment of Cervical Intra-epithelial Neoplasia (VACCIN study) a study protocol for a randomised controlled trial.,"BACKGROUND Cervical cancer is caused by Human Papilloma viruses (HPV) and is preceded by precursor stages: Cervical Intraepithelial Neoplasia (CIN). CIN is mostly found in women in their reproductive age and treated with a Loop Electrosurgical Excision Procedure (LEEP). The recurrence or residual disease rate after treatment is up to 17%. These women have a lifelong increased risk of recurrent CIN, cervical cancer and other HPV related malignancies. Furthermore, LEEP treatments are associated with complications such as premature birth. Limited data show that prophylactic HPV vaccination at the time of LEEP reduces recurrence rates, therefore leading to a reduction in repeated surgical interventions and side effect like preterm birth. The primary study objective is to evaluate the efficacy of the nonavalent HPV vaccination in women with a CIN II-III (high-grade squamous intraepithelial lesion (HSIL) lesion who will undergo a LEEP in preventing recurrent CIN II-III after 24 months. METHODS This study is a randomised, double blinded, placebo controlled trial in 750 patients without prior HPV vaccination or prior treatment for CIN and with histologically proven CIN II-III (independent of their hrHPV status) for whom a LEEP is planned. Included patients will be randomised to receive either three injections with nonavalent (9 HPV types) HPV vaccine or placebo injections (NaCL 0.9%) as a comparator. Treatment and follow-up will be according the current Dutch guidelines. Primary outcome is recurrence of a CIN II or CIN III lesion at 24 months. A normal PAP smear with negative hrHPV test serves as surrogate for absence of CIN. At the start and throughout the study HPV typing, quality of life and cost effectiveness will be tested. DISCUSSION Although prophylactic HPV vaccines are highly effective, little is known about the effectivity of HPV vaccines on women with CIN. Multiple LEEP treatments are associated with complications. We would like to evaluate the efficacy of HPV vaccination in addition to LEEP treatment to prevent residual or recurrent cervical dysplasia and decrease risks of repeated surgical treatment. TRIAL REGISTRATION Medical Ethical Committee approval number: NL66775.078.18. Affiliation: Erasmus Medical Centre. Dutch trial register: NL 7938. Date of registration 2019-08-05.",2020,CIN is mostly found in women in their reproductive age and treated with a Loop Electrosurgical Excision Procedure (LEEP).,"['women with a CIN II-III (high-grade squamous intraepithelial lesion (HSIL) lesion who will undergo a LEEP in preventing recurrent CIN II-III after 24\u2009months', '750 patients without prior HPV vaccination or prior treatment for CIN and with histologically proven CIN II-III (independent of their hrHPV status) for whom a LEEP is planned', 'women with CIN', 'Affiliation']","['LEEP', 'HPV vaccine or placebo injections (NaCL 0.9%) as a comparator', 'Loop Electrosurgical Excision Procedure (LEEP', 'nonavalent HPV vaccination', 'Adjuvant VACcination against HPV', 'placebo']","['recurrence of a CIN II or CIN III lesion', 'quality of life and cost effectiveness', 'recurrence or residual disease rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}]",750.0,0.333607,CIN is mostly found in women in their reproductive age and treated with a Loop Electrosurgical Excision Procedure (LEEP).,"[{'ForeName': 'R L O', 'Initials': 'RLO', 'LastName': 'van de Laar', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, PO Box: 2040, 3000 CA, Rotterdam, The Netherlands. r.vandelaar@erasmusmc.nl.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hofhuis', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Gasthuis, PO Box: 10900, 3004 BA, Rotterdam, The Netherlands.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Clinical trials unit of the Dutch Society for Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Center for Medical Decision Sciences, Erasmus MC- University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'W J G', 'Initials': 'WJG', 'LastName': 'Melchers', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Centre, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'van Kemenade', 'Affiliation': 'Department of Pathology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, 3000 CA, The Netherlands.'}, {'ForeName': 'R L M', 'Initials': 'RLM', 'LastName': 'Bekkers', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, the Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Van Beekhuizen', 'Affiliation': 'Department of Gynecologic Oncology, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, PO Box: 2040, 3000 CA, Rotterdam, The Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07025-7'] 2656,32517674,Reducing stigma and increasing workplace productivity due to mental health difficulties in a large government organization in the UK: a protocol for a randomised control treatment trial (RCT) of a low intensity psychological intervention and stigma reduction programme for common mental disorder (Prevail).,"BACKGROUND Common mental disorders are the leading cause of workplace absences. While the reasons for this are multifarious, there is little doubt that stigma related to common mental disorder plays a large role in sickness absence and in poor help-seeking. Frequently both managers and staff are unsure of how to approach and intervene with mental health related problems. We have therefore devised a mental health intervention programme (Prevail) that aims to reduce stigma and to educate staff about evidence-based low intensity psychological interventions. These can be used by the individual, as well as in collaboration with managers via co-production of problem-focussed solutions, with the aim of improving mental health, reducing sickness absence, and increasing workplace productivity. METHODS This two-armed cluster randomised control trial (RCT) will evaluate the effectiveness of Prevail. Eighty managers at a large UK government institution (the DVLA) and their teams (approximately 960 employees) will be randomised into the active intervention group or control (employment as usual) arms of the study. All participants will be invited to complete a series of questionnaires related to mental health stigma, their current and past mental health, and their recent workplace productivity (absenteeism and presenteeism). All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder. The managers in the active arm will also receive the Prevail Managers programme which covers communication skills, problem formulation, and problem-solving skills. The questionnaire battery will then be given to both groups again 4 weeks post training, and 12 months post-training. Official records of absenteeism from Human Resources will also be gathered from both active and control groups at 12 months post-training. DISCUSSION The treatment trial aims to evaluate if Prevail reduces mental health related stigma (of a number of forms), increases help-seeking behaviours, and increases workplace productivity (via decreased absenteeism and presenteeism). TRIAL REGISTRATION ISRCTN12040087. Retrospectively registered 04/05/2020.",2020,"All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder.","['common mental disorder (Prevail', 'All participants will be invited to complete a series of questionnaires related to mental health stigma, their current and past mental health, and their recent workplace productivity (absenteeism and presenteeism', 'Eighty managers at a large UK government institution (the DVLA) and their teams (approximately 960 employees']","['active intervention group or control (employment as usual', 'low intensity psychological intervention and stigma reduction programme', 'psychoeducation about evidence-based low intensity psychological interventions']",['workplace productivity'],"[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.21631,"All employees in the active arm will receive the Prevail Staff intervention, which covers stigma reduction and includes psychoeducation about evidence-based low intensity psychological interventions for common mental disorder.","[{'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Gray', 'Affiliation': 'Department of Psychology, College of Human and Health Sciences, Swansea University, Swansea, Wales, SA2 8PP, UK. Nicola.s.gray@swansea.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Davies', 'Affiliation': 'Driver and Vehicle Licensing Agency (DVLA), Swansea, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Snowden', 'Affiliation': 'School of Psychology, Cardiff University, Cardiff, UK.'}]",BMC public health,['10.1186/s12889-020-09054-0'] 2657,32517727,"LIVE@Home.Path-innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial.","BACKGROUND The global health challenge of dementia is exceptional in size, cost and impact. It is the only top ten cause of death that cannot be prevented, cured or substantially slowed, leaving disease management, caregiver support and service innovation as the main targets for reduction of disease burden. Institutionalization of persons with dementia is common in western countries, despite patients preferring to live longer at home, supported by caregivers. Such complex health challenges warrant multicomponent interventions thoroughly implemented in daily clinical practice. This article describes the rationale, development, feasibility testing and implementation process of the LIVE@Home.Path trial. METHODS The LIVE@Home.Path trial is a 2-year, multicenter, mixed-method, stepped-wedge randomized controlled trial, aiming to include 315 dyads of home-dwelling people with dementia and their caregivers, recruited from 3 municipalities in Norway. The stepped-wedge randomization implies that all dyads receive the intervention, but the timing is determined by randomization. The control group constitutes the dyads waiting for the intervention. The multicomponent intervention was developed in collaboration with user-representatives, researchers and stakeholders to meet the requirements from the national Dementia Plan 2020. During the 6-month intervention period, the participants will be allocated to a municipal coordinator, the core feature of the intervention, responsible for regular contact with the dyads to facilitate L: Learning, I: Innovation, V: Volunteering and E: Empowerment (LIVE). The primary outcome is resource utilization. This is measured by the Resource Utilization in Dementia (RUD) instrument and the Relative Stress Scale (RSS), reflecting that resource utilization is more than the actual time required for caring but also how burdensome the task is experienced by the caregiver. DISCUSSION We expect the implementation of LIVE to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. TRIAL REGISTRATION ClinicalTrials.gov: NCT04043364. Registered on 15 March 2019.",2020,"We expect the implementation of LIVE to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. ","['persons with dementia', '315 dyads of home-dwelling people with dementia and their caregivers, recruited from 3 municipalities in Norway', 'home-dwelling people with dementia and their caregivers']",['regular contact with the dyads to facilitate L'],['resource utilization'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0978429,"We expect the implementation of LIVE to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. ","[{'ForeName': 'Bettina Sandgathe', 'Initials': 'BS', 'LastName': 'Husebo', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Allore', 'Affiliation': 'Department of Internal Medicine, Section of Geriatrics, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wilco', 'Initials': 'W', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Renira Corinne', 'Initials': 'RC', 'LastName': 'Angeles', 'Affiliation': 'NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Frøydis Kristine', 'Initials': 'FK', 'LastName': 'Bruvik', 'Affiliation': 'Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Stein Erik', 'Initials': 'SE', 'LastName': 'Fæø', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Marie Hidle', 'Initials': 'MH', 'LastName': 'Gedde', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirin', 'Initials': 'E', 'LastName': 'Hillestad', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Frode Fadnes', 'Initials': 'FF', 'LastName': 'Jacobsen', 'Affiliation': 'Vid Specialized University, Bergen, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Kirkevold', 'Affiliation': 'Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Lillehamner, Norway.'}, {'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Kjerstad', 'Affiliation': 'NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Reidun Lisbeth Skeide', 'Initials': 'RLS', 'LastName': 'Kjome', 'Affiliation': 'Centre for Pharmacy, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Mannseth', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Naik', 'Affiliation': 'Haraldsplass Deaconess Hospital, Bergen, Norway.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University, Tohoku, Japan.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Puaschitz', 'Affiliation': 'Centre for Care Research, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Samdal', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Tranvåg', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Tzoulis', 'Affiliation': 'Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ipsit Vihang', 'Initials': 'IV', 'LastName': 'Vahia', 'Affiliation': 'McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maarja', 'Initials': 'M', 'LastName': 'Vislapuu', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Line Iden', 'Initials': 'LI', 'LastName': 'Berge', 'Affiliation': 'Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway. Line.Berge@uib.no.'}]",Trials,['10.1186/s13063-020-04414-y'] 2658,32517806,Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial.,"BACKGROUND Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. METHODS Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness. DISCUSSION We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs. TRIAL REGISTRATION ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.",2020,The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months.,"['hypertension control in Guatemala', '18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total']","['multicomponent program', 'protocol-based hypertension\xa0treatment using a\xa0standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback']","['systolic and diastolic blood pressure', 'proportion of patients with controlled hypertension', 'implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",44.0,0.0630916,The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months.,"[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Paniagua-Avila', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Meredith P', 'Initials': 'MP', 'LastName': 'Fort', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Department of Family Medicine, and Adult and Child Center for Health Outcomes Research and Delivery Science, University of Colorado, Aurora, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Gulayin', 'Affiliation': 'Department of Research in Chronic Diseases, Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hernández-Galdamez', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Kristyne', 'Initials': 'K', 'LastName': 'Mansilla', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Palacios', 'Affiliation': 'Programa Nacional de Enfermedades Crónicas, Ministerio de Salud y Asistencia Social (MSPAS), Guatemala City, Guatemala.'}, {'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'Peralta', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Roche', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Rubinstein', 'Affiliation': 'Programa Nacional de Enfermedades Crónicas, Ministerio de Salud y Asistencia Social (MSPAS), Guatemala City, Guatemala.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine and Tulane University Translational Science Institute, New Orleans, LA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala. mramirez@incap.int.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine and Tulane University Translational Science Institute, New Orleans, LA, USA.'}]",Trials,['10.1186/s13063-020-04345-8'] 2659,32517847,Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy.,"BACKGROUND Epicutaneous immunotherapy is a potential novel immunotherapy that utilizes unique cutaneous immunologicproperties. In a phase III, randomized, double-blind, placebo controlled clinical trial, an epicutaneous patch (DBV712) with 250 micrograms of peanut protein applied once daily for 12-months was statistically superior to placebo in desensitizing children with peanut allergy (ages 4-11 years) (N = 356). OBJECTIVE To assess the relationship between the hours of daily application time and the efficacy of DBV712 250 micrograms. METHODS DBV712 250 micrograms was applied to 30 nonallergic volunteers for various durations from 2 to 24 hours and thenassayed for residual peanut protein. Patch application data from the phase III clinical trial were analyzed post hoc accordingto prespecified responder rates and changes in the eliciting dose (ED), as measured by the geometric mean (GM) ED ratio (12months/baseline). RESULTS Following application, there was a marked decrease in peanut protein on the patches from 2 to 12 hours. After 12 hours, the median peanut protein recovered was below quantification limits. The median daily patch application duration in subjects from the phase III clinical trial was 21.1 hours (DBV712 250 micrograms) and 22.4 hours (placebo). Ninety-five percent of the treated population achieved >10 hours per day mean application. Response rates and GM ED ratios were similar among subjects across a range of application durations; e.g., in those with a mean duration of >10 hours, the response rate was 36.6% and the GM ED ratio was 3.8, comparable with 42.6% and 4.0, respectively, in those with a mean duration of >20 hours. In DBV712 250 micrograms subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). CONCLUSION An evaluation of residual peanut protein on patches following application and post hoc analysis of phase IIIdata strongly suggest that allergen delivery is attained with 12-16 hours of daily patch application time, sufficient to driveclinically meaningful desensitization to peanut after 12 months.",2020,"In DBV712 250 micrograms subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). ","['desensitizing children with peanut allergy (ages 4-11 years', '30 nonallergic volunteers for various durations from 2 to 24 hours and thenassayed for residual peanut protein', 'peanut allergy']","['epicutaneous patch (DBV712) with 250 micrograms of peanut protein', 'DBV712 250 micrograms', 'placebo']","['geometric mean (GM) ED ratio (12months/baseline', 'response rate', 'median peanut protein', 'median daily patch application duration', 'peanut protein', 'Response rates and GM ED ratios']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",356.0,0.140751,"In DBV712 250 micrograms subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). ","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Spergel', 'Affiliation': ''}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Bee', 'Affiliation': ''}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lambert', 'Affiliation': ''}, {'ForeName': 'Terrance', 'Initials': 'T', 'LastName': 'Ocheltree', 'Affiliation': ''}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': ''}]",Allergy and asthma proceedings,['10.2500/aap.2020.41.200045'] 2660,32518012,A multimodality triage algorithm to improve cytoreductive outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center team ovary initiative.,"OBJECTIVE To describe outcomes using a multimodal algorithm to triage patients with advanced epithelial ovarian cancer (EOC) to primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT). METHODS All patients with EOC treated at our institution from 04/2015-08/2018 were identified. We included patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score. A low risk score for suboptimal cytoreduction was defined as ≤6, and a high risk score ≥7. Patients were triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score. RESULTS Among 299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score. For patients with a low risk score, management included laparotomy/PDS, 181 (80%); LSC, 43 (19%) (with subsequent triage: PDS, 31; NACT, 12); and NACT, 2 (1%). For patients with a high risk score, management included laparotomy/PDS, 9 (12%); LSC, 51 (70%) (with subsequent triage: PDS, 28; NACT, 23); and NACT, 13 (18%). Overall, 83% underwent PDS, with a 75% CGR rate and 94% optimal cytoreduction rate. Use of the algorithm resulted in a 31% LSC rate and a 6% rate of suboptimal PDS. CONCLUSIONS The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.",2020,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","['triage patients with advanced epithelial ovarian cancer (EOC', 'patients undergoing primary debulking surgery for advanced ovarian cancer', '299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score', 'All patients with EOC treated at our institution from 04/2015-08/2018 were identified', 'patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score']",['primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT'],"['cytoreductive outcomes', 'triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score']","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",299.0,0.0508146,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","[{'ForeName': 'Alli M', 'Initials': 'AM', 'LastName': 'Straubhar', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Olga T', 'Initials': 'OT', 'LastName': 'Filippova', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Cowan', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lakhman', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Nikolovski', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Torrisi', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Weining', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kara Long', 'Initials': 'KL', 'LastName': 'Roche', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA. Electronic address: longrock@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.041'] 2661,32519005,Hypertonic saline for fluid resuscitation in ICU patients post-cardiac surgery (HERACLES): a double-blind randomized controlled clinical trial.,"PURPOSE Recent evidence questions a liberal approach to fluid resuscitation in intensive care unit (ICU) patients. Here, we assess whether use of hypertonic saline applied as single infusion at ICU admission after cardiac surgery can reduce cumulative perioperative fluid volume. METHODS Prospective randomized double-blind single-center clinical trial investigates effects of a single infusion of hypertonic saline (HS) versus normal saline (comparator). Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay). Upon ICU admission, patients received a single infusion of 5 ml/kg body weight of 7.3% NaCl (or 0.9% NaCl) over 60 min. Patients undergoing cardiac surgery for elective valvular and/or coronary heart disease were included. Patients with advanced organ dysfunction, infection, and/or patients on chronic steroid medication were excluded. RESULTS A total of 101 patients were randomized to receive the study intervention (HS n = 53, NS n = 48). Cumulative fluid intake on the ICU (primary endpoint) did not differ between the HS and the NS groups [median 3193 ml (IQR 2052-4333 ml) vs. 3345 ml (IQR 2332-5043 ml)]. Postoperative urinary output until ICU discharge was increased in HS-treated patients [median 2250 ml (IQR 1640-2690 ml) vs. 1545 ml (IQR 1087-1976 ml)], and ICU fluid balance was lower in the HS group when compared to the NS group [296 ml (IQR - 441 to 1412 ml) vs. 1137 ml (IQR 322-2660 ml)]. CONCLUSION In a monocentric prospective double-blind randomized clinical trial, we observed that hypertonic saline did not reduce the total fluid volume administered on the ICU in critically ill cardiac surgery patients. Hypertonic saline infusion was associated with timely increase in urinary output. Variations in electrolyte and acid-base homeostasis were transient, but substantial in all patients.",2020,Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay).,"['ICU patients post-cardiac surgery (HERACLES', 'intensive care unit (ICU) patients', 'Patients with advanced organ dysfunction, infection, and/or patients on chronic steroid medication were excluded', '101 patients', 'critically ill cardiac surgery patients', 'Patients undergoing cardiac surgery for elective valvular and/or coronary heart disease']","['hypertonic saline (HS) versus normal saline (comparator', 'hypertonic saline', 'Hypertonic saline']","['Postoperative urinary output until ICU discharge', 'cumulative amount of fluid', 'ICU fluid balance', 'total fluid volume', 'urinary output', 'Cumulative fluid intake']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}]",101.0,0.791992,Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay).,"[{'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Pfortmueller', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland. Carmen.Pfortmueller@insel.ch.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Kindler', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Schenk', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Messmer', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hess', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Wenger', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Waskowski', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zuercher', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Stoehr', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Englberger', 'Affiliation': 'Department of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Joerg C', 'Initials': 'JC', 'LastName': 'Schefold', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}]",Intensive care medicine,['10.1007/s00134-020-06132-0'] 2662,32519140,"Oral IBGard™ Before Colonoscopy: A Single-Center Double-Blinded, Randomized, Placebo-Controlled Trial.","BACKGROUND Peppermint oil is well known to inhibit smooth muscle contractions, and its topical administration during colonoscopy is reported to reduce colonic spasms. AIMS We aimed to assess whether oral administration of IBGard™, a sustained-release peppermint oil formulation, before colonoscopy reduces spasms and improves adenoma detection rate (ADR).  METHODS: We performed a single-center randomized, double-blinded, placebo-controlled trial. Patients undergoing screening or surveillance colonoscopies were randomized to receive IBGard™ or placebo. The endoscopist graded spasms during insertion, inspection, and polypectomy. Bowel preparation, procedure time, and time of drug administration were documented. Statistical analysis was performed using the Student's t test and Wilcoxon rank-sum test. RESULTS There was no significant difference in baseline characteristics or dose-timing distribution between IBGard™ and placebo groups. Similarly, there was no difference in ADR (IBGard™ = 47.8%, placebo = 43.1%, p = 0.51), intubation spasm score (1.23 vs 1.2, p = 0.9), withdrawal spasm score (1.3 vs 1.23, p = 0.72), or polypectomy spasm score (0.52 vs 0.46, p = 0.69). Limiting the analysis to patients who received the drug more than 60 min prior to the start of the procedure did not produce any significant differences in these endpoints. CONCLUSIONS This randomized controlled trial failed to show benefit of orally administered IBGard™ prior to colonoscopy on the presence of colonic spasms or ADR. Because of its low barrier to widespread adoption, the use of appropriately formulated and timed oral peppermint oil warrants further study to determine its efficacy in reducing colonic spasms and improving colonoscopy quality.",2020,This randomized controlled trial failed to show benefit of orally administered IBGard™ prior to colonoscopy on the presence of colonic spasms or ADR.,['Patients undergoing screening or surveillance colonoscopies'],"['Oral IBGard™', 'Placebo', 'IBGard™ or placebo', 'placebo']","['ADR', 'withdrawal spasm score', 'intubation spasm score', 'polypectomy spasm score', 'adenoma detection rate (ADR', 'colonic spasms or ADR', 'Bowel preparation, procedure time, and time of drug administration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]",,0.763835,This randomized controlled trial failed to show benefit of orally administered IBGard™ prior to colonoscopy on the presence of colonic spasms or ADR.,"[{'ForeName': 'James Y', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Moosvi', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA. zmoosvi@uci.edu.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Duh', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Albers', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Samarasena', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Karnes', 'Affiliation': 'Department of Medicine, H. H. Chao Comprehensive Digestive Disease Center, University of California: Irvine Medical Center, Orange, CA, 92868, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06383-3'] 2663,32519208,Assessment of Psychosocial Functioning in a Large Cohort of Patients with Schizophrenia.,"BACKGROUND This study addresses the question of whether psychosocial functioning measured by the Personal and Social Performance (PSP) Scale is related to various psychopathological measures in a cohort of patients with schizophrenia. METHODS The 'Neuroleptic Strategy Study' (NeSSy) performed at 14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs. Secondary end-points were the two PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS). RESULTS 149 patients were randomised. There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP. There were differences in doctors' assessments regarding psychosocial functioning compared with patients' own assessments. Furthermore, there were relationships between the PSP and quality of life, level of skills (ICF), and severity of disease (PANSS), level of sexual activities and poor well-being under antipsychotic medication but not with cognitive changes. CONCLUSIONS The findings on psychosocial functioning of patients with schizophrenia related to severity and skill level could be confirmed. Further findings were the correlation between psychosocial functioning and quality of life, well-being under treatment, and sexuality what emphasizes the substantial importance of a reduced psychosocial functioning.",2020,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"['patients with schizophrenia', 'Patients with Schizophrenia', '14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs', '149 patients were randomised']",[],"['PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS', ""doctors' assessments regarding psychosocial functioning"", 'Personal and Social Performance (PSP', 'psychosocial functioning and quality of life', 'PSP and quality of life, level of skills (ICF), and severity of disease (PANSS), level of sexual activities and poor well-being under antipsychotic medication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C5191071', 'cui_str': '149'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",149.0,0.0268036,There was no difference between the two treatment strategies (first-generation versus second-generation antipsychotics) with regard to the PSP.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kossmann', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Heller', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brüne', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heinze', 'Affiliation': 'Brandenburg Medical School, University Clinic for Psychiatry and Psychotherapy, Immanuel Klinik Rüdersdorf, Rüdersdorf, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mühlbauer', 'Affiliation': 'Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rüther', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Timm', 'Affiliation': 'Competence Centre for Clinical Trials - Biometry, University of Bremen, Bremen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gründer', 'Affiliation': 'Department of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry, Ruhr University Bochum, LWL University Hospital, Alexandrinenstr. 1-3, 44791, Bochum, Germany. georg.juckel@rub.de.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09773-y'] 2664,32519221,The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus.,"AIMS Although strategies to prevent premature sensor loss for flash glucose monitoring (FGM) systems may have substantial benefit, limited data are available. This study among youth with high-risk type 1 diabetes evaluated whether an additional adhesive patch over FGM sensors would reduce premature sensor loss frequency and not cause additional cutaneous adverse events (AEs). METHODS This is a six-month, open-label, randomized crossover trial. Participants were recruited at completion of prior 'Managing Diabetes in a Flash' randomized controlled trial and allocated to three months of Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention), before crossing over to the opposite study arm. Participants self-reported patch use or non-use, premature sensor loss and cutaneous AEs fortnightly via an electronic questionnaire. RESULTS Thirty-four participants were enrolled: mean age (± SD) 17.0 (± 2.2) years; mean HbA1c (± SD) 89 (± 16) mmol/mol (10.3% ± 1.4%). The response rate of questionnaires was 77% (314/408). Premature sensor loss was reported in 18% (58/314) of questionnaires: 20% (32/162) from intervention and 17% (26/152) from control (p = 0.56). Thirty-eight percent (118/314) of questionnaires were non-compliant to protocol allocation. However, per-protocol analysis showed similar findings. No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27). CONCLUSIONS The adhesive patch investigated in this study does not appear to prevent premature FGM sensor loss. However, the low risk of AEs and low cost of an adhesive patch suggest an individualized approach to their use may still be warranted. Further research is needed to explore alternative strategies to prevent sensor loss.",2020,"No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27). ","['youth with high-risk type 1 diabetes', 'mean age (±\u2009SD) 17.0 (±\u20092.2)\xa0years; mean', 'Thirty-four participants were enrolled', 'youth with type 1 diabetes mellitus']","['additional adhesive patch', 'additional adhesive patch over FGM sensors', 'Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention']","['Premature sensor loss', 'response rate of questionnaires', 'freestyle libre sensor life']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",34.0,0.0932723,"No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27). ","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Lange', 'Affiliation': 'Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Elbalshy', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand. ben.wheeler@otago.ac.nz.""}]",Acta diabetologica,['10.1007/s00592-020-01556-y'] 2665,32519431,Optimizing patient expectations to improve therapeutic response to medical treatment: A randomized controlled trial of iron infusion therapy.,"OBJECTIVES Patient expectations have the ability to influence health outcomes and have been shown to play an important role as part of the placebo effect to influence the response to medical treatments. Increasing positive expectations have been proposed as an intervention to improve treatment response, although evidence for this to date is limited. We investigated whether a brief 10-min intervention directly targeting patient expectations prior to an iron infusion could enhance expectations and improve treatment response, in terms of patients' reported fatigue. DESIGN Randomized controlled trial. METHODS Forty-three patients diagnosed with iron deficiency anaemia were randomized to a brief expectation intervention or active control group prior to an intravenous iron infusion. Chalder Fatigue Scale scores were assessed prior to randomization and at one and four weeks. RESULTS The expectation intervention significantly improved patients' expectations about the effectiveness of the intravenous iron infusion, t(21) = -3.95, p = .001. While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019. This was largely influenced by a significant reduction in physical, as opposed to mental fatigue scores. CONCLUSIONS Boosting patients' positive expectations may be an effective way of enhancing patient response to treatment. In particular, targeting patient expectations with a brief intervention prior to medical treatments may result in a greater and longer therapeutic effect.",2020,"While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019.",['Forty-three patients diagnosed with iron deficiency anaemia'],['brief expectation intervention or active control group prior to an intravenous iron infusion'],"['Chalder Fatigue Scale scores', 'fatigue']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.104222,"While there were no significant differences between groups in fatigue at the one-week follow-up, fatigue was significantly lower in the intervention group at the four-week follow-up compared to the control group, F(1, 25) = 6.25, p = .019.","[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Akroyd', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Kerry N', 'Initials': 'KN', 'LastName': 'Gunn', 'Affiliation': 'Department of Anaesthesia, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rankin', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Meihana', 'Initials': 'M', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Division of Clinical Psychology, University of Marburg, Germany.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}]",British journal of health psychology,['10.1111/bjhp.12435'] 2666,32519507,Role of vitamin D in oxidative stress modulation in end-stage renal disease patients: A double-blind randomized clinical trial.,"INTRODUCTION Oxidative stress is considered as important actor in uremia-associated morbidity and mortality in hemodialysis (HD) patients. We aimed to evaluate the role of vitamin D supplementation on oxidative stress parameters in this group. METHODS This double-blind randomized clinical trial was conducted on HD patients who were randomly allocated into intervention (n = 40) or control groups (n = 38) for 10 weeks. Blood samples were taken before and at the end of the trial to measure serum 25-hydroxyvitamin D (25(OH)D), malondialdehyde (MDA), glutathione peroxidase (GPx), catalase (CAT), and superoxide dismutase (SOD). Data were analyzed using SPSS, and P value <0.05 was considered to be statistically significant. FINDINGS Out of the 78 patients with a mean age of 44.7 ± 13.0 years, 55.1% were men. At the commencement of the study, there was no difference with respect to serum 25(OH)D levels in our groups (P = 0.575), but during the study it was significantly elevated in the intervention group (18.1 ± 9.1 vs. 31.7 ± 12.9, P < 0.0001). Serum antioxidative enzymes activity (GPx, CAT, and SOD) had significantly increased after vitamin D supplementation in the intervention group (P < 0.05). Furthermore, MDA levels was significantly reduced only in the intervention group (31.7 ± 18.0 vs. 24.7 ± 7.7, P = 0.018). DISCUSSION Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients. Since no adverse effects of vitamin D supplementation was reported by the patients; hence, it can be prescribed for HD patients.",2020,"Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients.","['end-stage renal disease patients', 'HD patients who were randomly allocated into intervention (n =\u200940) or control groups (n =\u200938) for 10\u2009weeks', '78 patients with a mean age of 44.7\u2009±\u200913.0\u2009years, 55.1% were men', 'HD patients', 'hemodialysis (HD) patients']","['vitamin D', 'vitamin D supplementation']","['Serum antioxidative enzymes activity (GPx, CAT, and SOD', 'oxidative stress parameters', 'serum 25-hydroxyvitamin D (25(OH)D), malondialdehyde (MDA), glutathione peroxidase (GPx), catalase (CAT), and superoxide dismutase (SOD', 'MDA plasma levels', 'MDA levels', 'serum 25(OH)D levels']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",78.0,0.151614,"Regular consumption of vitamin D can increase the GPx, CAT, SOD, and reduce the MDA plasma levels in HD patients.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Malekmakan', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mansourian', 'Affiliation': 'Department of Anesthesiology, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Pakfetrat', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Roozbeh', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khojaste', 'Initials': 'K', 'LastName': 'Rahimi Jaberi', 'Affiliation': 'Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12849'] 2667,32519525,Assessment of eating behaviours in adult residents of Greece and Poland - an original research.,"Background The length and the quality of life are determined by, among other things, environmental factors. The place of residence is associated with certain differences in nutritional culture, with food traditions and customs being of great importance. Also, the location of a given country in a specific climate zone has an impact on the choice of food products and their preparation. Objective The aim of the study was to analyse eating behaviours among adult residents of Greece and Poland as well as to investigate to what extent these behaviours are impacted by the place of residence of respondents. Materials and methods A total of 633 randomized respondents at the age of 50 or older (312 Greeks and 321 Poles) were included in the study. The author's questionnaire was used in the research. Results A total of 41.07% of respondents, including 31.09% of Greeks and 50.78% of Poles, declared having 4-5 meals per day. Fish was consumed 1-2 times a week by 29.27% of respondents, including 23.40% of Greeks and 15.26% of Poles. Whole wheat bread was consumed several times daily by 20.7% of respondents, including 19.55% of Greeks and 21.81% of Poles. Coarse groats and pasta were consumed a few times weekly by 23.06% of respondents, including 25.64% of Greeks and 20.56% of Poles. Conclusions Eating behaviours in adult Poles and Greeks are varied, with healthier eating habits in the latter group. There are significant differences between the intake of food products rich in fibre and omega-3 fatty acids by residents of Greece and Poland.",2020,There are significant differences between the intake of food products rich in fibre and omega-3 fatty acids by residents of Greece and Poland.,"['adult residents of Greece and Poland - an original research', '633 randomized respondents at the age of 50 or older (312 Greeks and 321 Poles', 'adult residents of Greece and Poland']",[],"['eating behaviours', 'length and the quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0337815', 'cui_str': 'Poles'}]",[],"[{'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",633.0,0.0554397,There are significant differences between the intake of food products rich in fibre and omega-3 fatty acids by residents of Greece and Poland.,"[{'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Szczepańska', 'Affiliation': 'Department of Human Nutrition, School of Health Sciences in Bytom, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rzepecka', 'Affiliation': 'Scientific Society of Young Educators, Department of Human Nutrition, School of Health Sciences in Bytom, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Góra', 'Affiliation': 'Scientific Society of Young Educators, Department of Human Nutrition, School of Health Sciences in Bytom, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janion', 'Affiliation': 'Department of Nutrition-Related Disease Prevention, Department of Metabolic Disease Prevention, School of Health Sciences in Bytom, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Urbańczyk', 'Affiliation': 'Scientific Society of Young Educators, Department of Human Nutrition, School of Health Sciences in Bytom, Medical University of Silesia in Katowice, Poland.'}]",Roczniki Panstwowego Zakladu Higieny,['10.32394/rpzh.2020.0108'] 2668,32519569,Randomised clinical study of the impact of routine preoperative Doppler ultrasound for the outcome of autologous arteriovenous fistulas for haemodialysis.,"BACKGROUND Arteriovenous fistulas are the gold standard of vascular accesses in haemodialysis; however, they have a considerable primary failure rate. This study evaluated the comparative reliability of routine preoperative Doppler ultrasound with an isolated physical examination of autologous arteriovenous fistulas within the Single Health System of Brazil and analysed the potential clinical benefit, improvement in primary failure rates and its economic impact. METHODS A non-blind randomised clinical study group of patients undergoing a vessel mapping with preoperative Doppler ultrasound (ultrasound group) and a control group who had undergone only a physical examination (clinical group) before the vascular procedures was performed. The role of the arteriovenous fistula in dialysis and possible alterations was evaluated in both the groups and followed up for 6 months. RESULTS Of the initial 248 eligible patients, there was a randomisation of 230 patients, 228 of whom were submitted for surgery, 114 in each group. In the clinical group, a significantly higher rate of primary failure was recorded, with 13.6% versus 4.4% in the ultrasound group ( p = 0.002). The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042). Regarding the cost-effectiveness of the use of Doppler ultrasound, there was no increase in the final cost compared to the physical examination (US$1.28/fistula day × US$1.29/fistula day). CONCLUSION It was concluded that Doppler ultrasound contributed to the reduction of primary failure, leading to a significantly superior primary patency of arteriovenous fistulas, and no increase in the final cost. This justifies its routine preoperative use in the Single Health System. Registration number RBR-474xhn ( http://www.ensaiosclinicos.gov.br ).",2020,The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042).,"['230 patients, 228 of whom were submitted for surgery, 114 in each group', 'patients undergoing a vessel mapping with preoperative Doppler ultrasound (ultrasound group) and a control group who had undergone only a physical examination (clinical group) before the vascular procedures was performed', 'autologous arteriovenous fistulas for haemodialysis', '248 eligible patients']","['routine preoperative Doppler ultrasound', 'Doppler ultrasound', 'routine preoperative Doppler ultrasound with an isolated physical examination of autologous arteriovenous fistulas']","['Registration number RBR-474xhn ( http://www.ensaiosclinicos.gov.br ', 'final cost', 'primary patency', 'rate of primary failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0303405', 'cui_str': 'Indium-114'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0279572,The Kaplan-Meier curve with log-rank analysis showed a significantly higher primary patency in the ultrasound group ( p = 0.042).,"[{'ForeName': 'Jocefábia Reika Alves', 'Initials': 'JRA', 'LastName': 'Lopes', 'Affiliation': 'Department of Vascular Surgery, Centro Universitário Saúde ABC, Santo André, Brazil.'}, {'ForeName': 'Ana Lígia de Barros', 'Initials': 'ALB', 'LastName': 'Marques', 'Affiliation': 'Department of Endocrinology, Federal University of Maranhão, Imperatriz, Brazil.'}, {'ForeName': 'João Antonio', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Vascular Surgery, Centro Universitário Saúde ABC, Santo André, Brazil.'}]",The journal of vascular access,['10.1177/1129729820927273'] 2669,32528635,Customers' perception of the attributes of different formats of menu labeling: a comparison between Korea and the U.S.,"BACKGROUND/OBJECTIVES This study compared the perception of customers from Korea and the U.S. on the attributes of different formats of menu labeling The specific objectives were 1) to compare the customers' perceived usefulness, ease-of-understanding, clarity, and attractiveness of different formats of menu labeling between Korea and the U.S.; and 2) to compare the customers' use intention to different formats of menu labeling between Korea and the U.S. SUBJECTS/METHODS A survey was conducted in Korea and the U.S. The participants were allocated randomly to view 1 of the 7 restaurant menus that varied according to the following types of menu labeling formats: (type 1) kcal format, (type 2) traffic-light format, (type 3) percent daily intake (%DI) format, (type 4) kcal + traffic-light format, (type 5) kcal + %DI format, (type 6) traffic-light + %DI format, and (type 7) kcal + traffic-light + %DI format. A total of 279 Koreans and 347 Americans were entered in the analysis. An independent t-test and 1-way analysis of variance were performed. RESULTS Koreans rated type 4 format (kcal + traffic light) the highest for usefulness and attractiveness. In contrast, Americans rated type 7 (kcal + traffic light + %DI) the highest for usefulness, ease-of-understanding, attractiveness, and clarity. Significant differences were found in the customers' perceived attributes to menu labeling between Korea and the U.S. Americans perceived higher for all the 4 attributes of menu labeling than Koreans. CONCLUSIONS The study is unique in identifying the differences in the attributes of different formats of menu labeling between Korea and the U.S. Americans rated the most complicated type of menu labeling as the highest perception for the attributes, and showed a higher use intention of menu labeling than Koreans. This study contributes to academia and industry for practicing menu labeling in different countries using different formats.",2020,"Significant differences were found in the customers' perceived attributes to menu labeling between Korea and the U.S. Americans perceived higher for all the 4 attributes of menu labeling than Koreans. ","['A survey was conducted in Korea and the U.S', 'A total of 279 Koreans and 347 Americans']","['menu labeling formats: (type 1) kcal format, (type 2) traffic-light format, (type 3) percent daily intake (%DI) format, (type 4) kcal + traffic-light format, (type 5) kcal + %DI format, (type 6) traffic-light + %DI format, and (type 7) kcal + traffic-light + %DI format']",[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C1960442', 'cui_str': 'Type 6'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],347.0,0.0351109,"Significant differences were found in the customers' perceived attributes to menu labeling between Korea and the U.S. Americans perceived higher for all the 4 attributes of menu labeling than Koreans. ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bosselman', 'Affiliation': 'Department of Apparel, Events & Hospitality Management, College of Human Sciences, Iowa State University, Ames, IA 50011, USA.'}, {'ForeName': 'Hyung-Min', 'Initials': 'HM', 'LastName': 'Choi', 'Affiliation': 'International Center for Hospitality Research & Development, Dedman School of Hospitality, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Keum Sil', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Tourism Management, Jangan University, Hwaseong 18331, Korea.'}, {'ForeName': 'Eojina', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Hospitality & Tourism Management, Pamplin College of Business, Virginia Tech, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Jaebin', 'Initials': 'J', 'LastName': 'Cha', 'Affiliation': 'Department of Health & Medical Administration, Kyungmin University, Uijeongbu 11618, Korea.'}, {'ForeName': 'Jin-Yi', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': 'Department of Food & Nutrition, Institute of Symbiotic Life-TECH, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Jo', 'Affiliation': 'Division of Hotel & Tourism, College of Economics & Business Administration, The University of Suwon, Hwaseong 18323, Korea.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Department of Food & Nutrition, Institute of Symbiotic Life-TECH, College of Human Ecology, Yonsei University, Seoul 03722, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.3.286'] 2670,32528643,Epinephrine delivery via EpiPen ® Auto-Injector or manual syringe across participants with a wide range of skin-to-muscle distances.,"Background Intramuscular (IM) injection of epinephrine (adrenaline) at the mid-anterolateral (AL) thigh is the international standard therapy for acute anaphylaxis. Concerns exist regarding implications of epinephrine auto-injector needles not penetrating the muscle in patients with greater skin-to-muscle-distances (STMD). Methods This open-label, randomized, crossover study investigated pharmacokinetics and pharmacodynamics following injection of epinephrine in healthy volunteers. Individuals were stratified by maximally compressed STMD (low, < 15 mm; moderate, 15-20 mm; high, > 20 mm). Participants received epinephrine injections via EpiPen ® Auto-Injector (EpiPen; 0.3 mg/0.3 mL) or IM syringe (0.3 mg/0.3 mL) at mid-AL thigh or received saline by IM syringe in a randomized order. Eligible participants received a fourth treatment (EpiPen [0.3 mg/0.3 mL] at distal-AL thigh). Model-independent pharmacokinetic parameters and pharmacodynamics were assessed. Results There were numerical trends toward higher peak epinephrine concentrations (0.52 vs 0.35 ng/mL; geometric mean ratio, 1.40; 90% CI 117.6-164.6%) and more rapid exposure (time to peak concentration, 20 vs 50 min) for EpiPen vs IM syringe at mid-AL thigh across STMD groups. Absorption was faster over the first 30 min for EpiPen vs IM syringe (partial area under curve [AUC] over first 30 min: geometric mean ratio, 2.13; 90% CI 159.0-285.0%). Overall exposure based on AUC to the last measurable concentration was similar for EpiPen vs IM syringe (geometric mean ratio, 1.13; 90% CI 98.8-129.8%). Epinephrine pharmacokinetics after EpiPen injection were similar across STMD groups. Treatments were well tolerated. Conclusions Epinephrine delivery via EpiPen resulted in greater early systemic exposure to epinephrine vs IM syringe as assessed by epinephrine plasma levels. Delivery via EpiPen was consistent across participants with a wide range of STMD, even when the needle may not have penetrated the muscle. Trial registrations This trial was registered with the German Clinical Trials Register (DRKS-ID: DRKS00011263; secondary ID, EudraCT 2016-000104-29) on 23 March 2017.",2020,"Conclusions Epinephrine delivery via EpiPen resulted in greater early systemic exposure to epinephrine vs IM syringe as assessed by epinephrine plasma levels.","['patients with greater skin-to-muscle-distances (STMD', 'healthy volunteers', 'across participants with a wide range of skin-to-muscle distances']","['epinephrine auto-injector needles', 'epinephrine injections via EpiPen ® Auto-Injector', '\n\n\nIntramuscular (IM) injection of epinephrine (adrenaline', 'saline by IM syringe', 'epinephrine', 'epinephrine vs IM syringe', 'IM syringe', 'Epinephrine delivery via EpiPen ® Auto-Injector or manual syringe']","['tolerated', 'epinephrine plasma levels', 'Epinephrine pharmacokinetics', 'peak epinephrine concentrations', 'Absorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C4047001', 'cui_str': 'Epinephrine Auto-Injector [Epipen]'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0730534', 'cui_str': 'Injection of epinephrine'}, {'cui': 'C0591454', 'cui_str': 'Epipen'}, {'cui': 'C2984091', 'cui_str': 'Auto-Injector'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.453707,"Conclusions Epinephrine delivery via EpiPen resulted in greater early systemic exposure to epinephrine vs IM syringe as assessed by epinephrine plasma levels.","[{'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology and Allergy, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'DucTung', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'Meda Pharma GmbH & Co KG, Bad Homburg vor der Hӧhe, Germany.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Rackley', 'Affiliation': 'Mylan Inc, Canonsburg, PA USA.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre, Department of Woman and Child Health, Padua University Hospital, Padua, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Du Toit', 'Affiliation': ""Children's Allergy Service, Evelina London, Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'Mylan Inc, Canonsburg, PA USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Mylan Inc, Canonsburg, PA USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Brumbaugh', 'Affiliation': 'Mylan Inc, Canonsburg, PA USA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Wickman', 'Affiliation': 'Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.'}]",Clinical and translational allergy,['10.1186/s13601-020-00326-x'] 2671,32528650,Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).,"Background: Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy. Methods: This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebanon. Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable, who has not been randomised before, for whom there are no known contraindications. Randomisation - stratified (by ward) randomisation and concealed in closed opaque envelope by independent parties. Procedure - if the clinical situation arises requiring rapid tranquilisation, medical residents overseeing the patient will open a TREC-Lebanon envelope in which will be notification of which group of treatments should be preferred [Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP)], along with forms for primary, secondary and serious adverse effects. Treatment is not given blindly. Outcome - primary outcome is calm or tranquil at 20 minutes post intervention. Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward. Follow-up will be up to two weeks post randomisation. Discussion: Findings from this study will compare the HPC versus HP combination used in Lebanon's psychiatry emergency routine practice. Trial registration: ClinicalTrials.gov NCT03639558. Registration date, August 21, 2018.",2019,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","['Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable', 'agitated psychiatric patients in the emergency setting (TREC-Lebanon']","['haloperidol, promethazine and chlorpromazine combination', 'HPC versus HP combination', 'haloperidol plus promethazine plus chlorpromazine', 'haloperidol plus promethazine', 'Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP']","['calm or tranquil at 20 minutes post intervention', 'calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",,0.351427,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dib', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, NG1 1NU, UK.'}, {'ForeName': 'Clive E', 'Initials': 'CE', 'LastName': 'Adams', 'Affiliation': 'Institution of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Werner Henry', 'Initials': 'WH', 'LastName': 'Ikdais', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Atallah', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Hiba Edward', 'Initials': 'HE', 'LastName': 'Yaacoub', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Tony Jean', 'Initials': 'TJ', 'LastName': 'Merheb', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Kazour', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Tahan', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Marouan', 'Initials': 'M', 'LastName': 'Zoghbi', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Azar', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Chadia', 'Initials': 'C', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Hallit', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik, Beirut, Lebanon.'}]",F1000Research,['10.12688/f1000research.19933.1'] 2672,32528665,"Impact of mobile technologies on cervical cancer screening practices in Lagos, Nigeria (mHealth-Cervix): Protocol for a randomised controlled trial.","Background: Incidence and mortality from cervical cancer have remained high due to many obstacles facing the implementation of organized screening programs in resource-constrained countries such as Nigeria. The application of mobile technologies (mHealth) to health services delivery has the potential to reduce inequalities, empower patients to control their health, and improve the cost-effectiveness of health care delivery. Aim: To assess the efficacy of mobile technology intervention on Pap test screening adherence compared to a control condition and also determine the factors affecting the uptake of Pap smear screening practices among women in Lagos. Methods: This is a multi-center randomized controlled trial that will involve women aged 25 to 65 years attending the General Outpatient clinics of the two tertiary health institutions in Lagos, Nigeria between April and December 2020. At baseline, a total of 200 National Health Insurance Scheme (NHIS) enrollees will be randomized to either a text message arm or usual care (control) arm. The primary outcome is the completion of a Pap smear within 6 months of enrolment in the study. The associations between any two groups of continuous variables will be tested using the independent sample t-test (normal distribution) or the Mann-Whitney U test (skewed data) and that of two groups of categorical variables with Chi-square X 2 or Fisher's exact test where appropriate. Using binary logistic regression model, we will adjust for age and other relevant sociodemographic and clinical variables and adherence to Pap test screening. Statistical significance will be defined as P -value less than 0.05. Discussion: The mHealth-Cervix study will evaluate the impact of mobile technologies on cervical cancer screening practices in Lagos, Nigeria as a way of contributing to the reduction in the wide disparities in cervical cancer incidence through early detection facilitated using health promotion to improve Pap smear screening adherence. Registration : PACTR202002753354517 13/02/2020.",2020,"The application of mobile technologies (mHealth) to health services delivery has the potential to reduce inequalities, empower patients to control their health, and improve the cost-effectiveness of health care delivery. ","['women aged 25 to 65 years attending the General Outpatient clinics of the two tertiary health institutions in Lagos, Nigeria between April and December 2020', 'cervical cancer screening practices in Lagos, Nigeria', 'Registration ', 'women in Lagos', 'cervical cancer screening practices in Lagos, Nigeria (mHealth-Cervix', '200 National Health Insurance Scheme (NHIS) enrollees']","['mobile technologies', 'mobile technology intervention', 'text message arm or usual care (control) arm']","['completion of a Pap smear', 'Pap test screening adherence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0773288,"The application of mobile technologies (mHealth) to health services delivery has the potential to reduce inequalities, empower patients to control their health, and improve the cost-effectiveness of health care delivery. ","[{'ForeName': 'Kehinde S', 'Initials': 'KS', 'LastName': 'Okunade', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Lagos, Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Omolola', 'Initials': 'O', 'LastName': 'Salako', 'Affiliation': 'Department of Radiation Biology, Radiotherapy and Radiodiagnosis, University of Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Adebola A', 'Initials': 'AA', 'LastName': 'Adejimi', 'Affiliation': 'Department of Community Health and Primary Care, University of Lagos, Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Oluwatosin J', 'Initials': 'OJ', 'LastName': 'Akinsola', 'Affiliation': 'Department of Community Health and Primary Care, University of Lagos, Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Omolara', 'Initials': 'O', 'LastName': 'Fatiregun', 'Affiliation': 'Department of Clinical and Radiation Oncology, Lagos State University Teaching Hospital,, Ikeja, Lagos, 2345, Nigeria.'}, {'ForeName': 'Muisi A', 'Initials': 'MA', 'LastName': 'Adenekan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital,, Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Olusanjo E', 'Initials': 'OE', 'LastName': 'Moses', 'Affiliation': 'Department of Obstetrics and Gynaecology, State University Teaching Hospital, Ikeja, Lagos, 2345, Nigeria.'}, {'ForeName': 'Bassey', 'Initials': 'B', 'LastName': 'Ebenso', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Allsop', 'Affiliation': 'Academic Unit of Palliative Care, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Rose I', 'Initials': 'RI', 'LastName': 'Anorlu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Lagos, Lagos, Lagos, 2345, Nigeria.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Berek', 'Affiliation': ""Stanford Women's Cancer Center, Stanford Cancer Institute, Stanford University School of Medicine, Palo Alto, California, 94304, USA.""}]",F1000Research,['10.12688/f1000research.22991.1'] 2673,32523153,"Clinical Evaluation of a Self-Adhering Flowable Resin Composite in Minimally Invasive Class I Cavities: 5-year Results of a Double Blind Randomized, Controlled Clinical Trial.","Objective The aim of this study was to evaluate the long-term clinical performance of a self-adhering flowable resin composite compared to a conventional flowable resin composite used with an etch&rinse adhesive system in minimally invasive Class I cavities. Materials and Methods Twenty-five patients received at least one pair of Class I restorations (n=65). After class I cavities had been prepared, they were randomly restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) [Group-1 (n=33)], or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse adhesive (Teco/DMG) [Group-2 (n=32)] according to the manufacturers' instructions. The restorations were evaluated at baseline and yearly during 5 years according to the FDI criteria by two evaluators. A statistical analysis was carried out using the Pearson Chi-Square test and the Cochran Q-test followed by the Mc Nemar's test (p=0.05). Results After 5 years a total of 47 restorations were evaluated with a recall rate of 68%. At 4-year, 3 (11.5%) VR and 2 LX (7.6%) restorations exhibited a cumulative retention loss. Seventeen (73.9%) VR and 14 LX (58.3%) restorations exhibited clinically acceptable (2) scores for marginal adaptation. At 5-year evaluations VR and LX showed similar results regarding all evaluated criteria ( p > 0.05). The cumulative retention loss rates of VR and LX were 15.3% and 7.6%, respectively. None of the restorations demonstrated a recurrence of caries and post operative sensitivity. Both materials showed significant changes at 4 and 5 years regarding marginal staining when compared to baseline (p<0.001). Furthermore, significant changes were observed for VR and LX at 1, 2, 3, 4 and 5 years for marginal adaptation according to baseline (p<0.001). Conclusion The use of both materials for the restoration of Class-I cavities demonstrated clinically acceptable performance at the end of 5-year. The self-adhering flowable composite exhibited a clinical performance similar to the conventional flowable applied with an etch&rinse adhesive.",2020,The self-adhering flowable composite exhibited a clinical performance similar to the conventional flowable applied with an etch&rinse adhesive.,"['Materials and Methods\n\n\nTwenty-five patients received at least one pair of Class I restorations (n=65', 'minimally invasive Class I cavities', 'Minimally Invasive Class I Cavities']","[""self-adhering flowable resin composite (VertiseFlow/Kerr-VR) [Group-1 (n=33)], or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch&rinse adhesive (Teco/DMG) [Group-2 (n=32)] according to the manufacturers' instructions"", 'Self-Adhering Flowable Resin Composite']","['cumulative retention loss', 'cumulative retention loss rates of VR and LX', 'recurrence of caries and post operative sensitivity']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",47.0,0.0466333,The self-adhering flowable composite exhibited a clinical performance similar to the conventional flowable applied with an etch&rinse adhesive.,"[{'ForeName': 'Fatma Dilsad', 'Initials': 'FD', 'LastName': 'Oz', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, TURKEY.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ergin', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, TURKEY.'}, {'ForeName': 'Filiz Yalcin', 'Initials': 'FY', 'LastName': 'Cakir', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, TURKEY.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Gurgan', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, TURKEY.'}]",Acta stomatologica Croatica,['10.15644/asc54/1/2'] 2674,32523156,Salivary Cortisol Levels and Burning Symptoms in Patients with Burning Mouth Syndrome before and after Low Level Laser Therapy: a Double Blind Controlled Randomized Clinical Trial.,"Objectives Burning mouth syndrome (BMS) is a disorder which is described as burning sensation of the oral mucosa without pathological changes. Most of the patients have some underlying stressful conditions. Stress induces an increase in secretion of different endocrine glands resulting in higher levels of glucocorticoids. One of the options for treatment of BMS includes low level laser therapy (LLLT). The aim of this research was to determine salivary cortisol levels and intensity of burning symptoms in BMS patients before and after LLLT. Materials and Methods Twenty-three participants were allocated by randomization in two groups: 12 patients in the study group and 11 patients in the placebo group. Cortisol levels in all patients were analyzed from the sample of saliva collected without stimulation. In both groups, the LLLT was performed once a day for ten consecutive days (excluding weekend) with Ga-Al-As light-emitting diode type of laser, with a wavelength of 685nm. In the control group, LLLT was done with inactive laser probe which was only emitting audio signal. The intensity of burning symptoms was measured by a visual analogue scale (VAS). The VAS and unstimulated saliva were measured at baseline and on the last day of the LLLT. A quantitative analysis of saliva was performed using competitive commercial ELISA-kit. Results VAS scores and salivary cortisol levels were significantly lower in both groups after LLLT. Conclusions LLLT can be useful in patients with BMS for reducing burning symptoms and salivary cortisol level. Future studies on a larger number of patients should clarify whether the positive results are an outcome of laser effectiveness or of placebo effect.",2020,"Results VAS scores and salivary cortisol levels were significantly lower in both groups after LLLT. ","['Materials and Methods\n\n\nTwenty-three participants were allocated by randomization in two groups: 12 patients in the study group and 11 patients in the', 'BMS patients before and after LLLT', 'Patients with Burning Mouth Syndrome before and after Low Level Laser Therapy']","['LLLT', 'placebo']","['visual analogue scale (VAS', 'intensity of burning symptoms', 'VAS and unstimulated saliva', 'Cortisol levels', 'salivary cortisol levels and intensity of burning symptoms', 'Salivary Cortisol Levels and Burning Symptoms', 'burning symptoms and salivary cortisol level', 'VAS scores and salivary cortisol levels']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",23.0,0.291696,"Results VAS scores and salivary cortisol levels were significantly lower in both groups after LLLT. ","[{'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Škrinjar', 'Affiliation': 'Department of Oral Medicine, University Hospital Center Zagreb, Gundulićeva 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'Božana', 'Initials': 'B', 'LastName': 'Lončar Brzak', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Vidranski', 'Affiliation': 'Department of Oncology and Nuclear Medicine, University Clinical Hospital Sisters of Mercy, Vinogradska cesta 29, 10000 Zagreb, Croatia.'}, {'ForeName': 'Vanja', 'Initials': 'V', 'LastName': 'Vučićević Boras', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine University of Zagreb and University Clinical Hospital Zagreb, Gundulićeva 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'Ana Andabak', 'Initials': 'AA', 'LastName': 'Rogulj', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'Božidar', 'Initials': 'B', 'LastName': 'Pavelić', 'Affiliation': 'Department of Restorative Dentistry, School of Dental Medicine, University of Zagreb and University Hospital Zagreb, Gundulićeva 5, 10000 Zagreb, Croatia.'}]",Acta stomatologica Croatica,['10.15644/asc54/1/5'] 2675,32523251,Effects of a short-term increase in physical activity on arterial stiffness during hyperglycemia.,"We examined the effects of increasing physical activity on arterial stiffness during hyperglycemia. Nineteen glucose-intolerant elderly participated in the study. We randomly assigned 10 participants to increase their daily activity in everyday life, regardless of the time or intensity, for 1 month (PAI group) (age, 74.6 ± 1.3 years; mean ± SE) and nine participants to maintain their level of activity (CON group) (age, 79.2 ± 2.1 years; mean ± SE). The 75-g oral glucose tolerance test was conducted in each participant in both groups before and after the start of the intervention to confirm glucose intolerance. Brachial-ankle pulse wave velocity and cardio-ankle vascular index significantly increased from baseline at 30, 60, and 90 min after the 75-g glucose ingestion after the intervention in the CON group ( p <0.05), but not in the PAI group. Heart-brachial pulse wave velocity did not change compared to baseline after the 75-g glucose ingestion in either group and did not change from baseline at 30, 60, and 90 min after the 75-g glucose ingestion before and after the intervention in both groups. The present findings indicate that a short-term increase in physical activity suppresses the increase in arterial stiffness after glucose intake.",2020,"Heart-brachial pulse wave velocity did not change compared to baseline after the 75-g glucose ingestion in either group and did not change from baseline at 30, 60, and 90 min after the 75-g glucose ingestion before and after the intervention in both groups.","['Nineteen glucose-intolerant elderly participated in the study', 'nine participants to maintain their level of activity (CON group) (age, 79.2\xa0±\xa02.1 years; mean\xa0±\xa0SE']",[],"['Heart-brachial pulse wave velocity', 'arterial stiffness', 'physical activity', 'Brachial-ankle pulse wave velocity and cardio-ankle vascular index', 'daily activity in everyday life, regardless of the time or intensity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1096531', 'cui_str': 'Brachial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",10.0,0.015224,"Heart-brachial pulse wave velocity did not change compared to baseline after the 75-g glucose ingestion in either group and did not change from baseline at 30, 60, and 90 min after the 75-g glucose ingestion before and after the intervention in both groups.","[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science, 2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo 120-0045, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'College of Liberal Arts, International Christian University, 3-10-2 Osawa, Mitaka-shi, Tokyo 181-8585, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Adachi-ku Track and Field Association, 1-33-22 Yanaka, Adachi-ku, Tokyo 120-0006, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Asaki', 'Affiliation': 'Department of Tokyo Judo Therapy, Teikyo University of Science, 2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo 120-0045, Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Iwanuma', 'Affiliation': 'Department of School Education, Teikyo University of Science, 2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo 120-0045, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Ohashi', 'Affiliation': 'Department of School Education, Teikyo University of Science, 2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo 120-0045, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of School Education, Teikyo University of Science, 2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo 120-0045, Japan.'}]",Journal of clinical biochemistry and nutrition,['10.3164/jcbn.19-69'] 2676,32523266,A Randomized Trial Comparing the Efficacy of Methylene Blue Dye Alone Versus Combination of Methylene Blue Dye and Radioactive Sulfur Colloid in Sentinel Lymph Node Biopsy for Early Stage Breast Cancer Patients.,"Although sentinel lymph node biopsy (SLNB) has become a standard of care for management of axilla in breast cancer patients, the technique of SLNB is still not well defined. Unlike radioactive sulfur colloid which requires nuclear medicine facilities, methylene blue dye is readily available. The purpose of this study is to validate the use of methylene blue dye alone for SLNB in early breast cancer patients. 60 patients of early breast cancer were randomized to receive either methylene blue alone (Group A-30 patients) or a combination of both methylene blue and radioactive colloid (Group B-30 patients) for detection of sentinel lymph nodes. Sentinel lymph node biopsy was done followed by complete axillary dissection in all patients. In both Groups A and B, sentinel node was identified in all 30 patients, giving identification rate of 100%. In group A, sentinel node was the only positive node in 1 patient, with a false-positive rate of 14.2%. The negative predictive value was 91.3%. The sensitivity of the procedure in predicting further axillary disease was 75% with a specificity of 95.45%. The overall accuracy was 90%. In group B, sentinel node was the only positive node in 2 cases, giving a false-positive rate of 28.7%. The negative predictive value was 95.65%. The sensitivity of the procedure in predicting further axillary disease was 83.33% with a specificity of 91.67%. The overall accuracy was 90%. Although the false-negative rate was slightly higher with methylene blue alone than that using combination (8.6%-4.3%), it was statistically insignificant. Similarly the sensitivity (75%-83.33%), specificity (95.45-91.67%), and negative predictive value (91.3%-95.67%) were also comparable between groups A and B, respectively. Negative predictive value and false-negative rates are comparable, whether blue dye is used alone or a combination of blue dye and radioactive colloid is used. Sentinel lymph node biopsy with blue dye alone is reliable and can be put to clinical practice more widely, even if nuclear medicine facilities are not available in resource constrained centers, so as to reduce long-term morbidity of axillary dissection, with similar oncological outcomes.",2020,The sensitivity of the procedure in predicting further axillary disease was 83.33% with a specificity of 91.67%.,"['60 patients of early breast cancer', 'breast cancer patients', 'Early Stage Breast Cancer Patients', 'early breast cancer patients']","['methylene blue alone (Group A-30 patients) or a combination of both methylene blue and radioactive colloid (Group B-30 patients) for detection of sentinel lymph nodes', 'Alone Versus Combination of Methylene Blue Dye and Radioactive Sulfur Colloid', 'Methylene Blue Dye', 'methylene blue alone', 'methylene blue dye alone', 'sentinel lymph node biopsy (SLNB']","['false-negative rate', 'sensitivity', 'specificity', 'overall accuracy', 'negative predictive value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0301352', 'cui_str': 'Colloid sulfur'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0278785,The sensitivity of the procedure in predicting further axillary disease was 83.33% with a specificity of 91.67%.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'Kvvn', 'Initials': 'K', 'LastName': 'Raju', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'T Subramanyeshwar', 'Initials': 'TS', 'LastName': 'Rao', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Naidu', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Hariharan', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'Ramachandra', 'Initials': 'R', 'LastName': 'Nagarajuch', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Madhunarayana', 'Affiliation': 'Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.'}]",Indian journal of surgical oncology,['10.1007/s13193-019-01023-3'] 2677,32523284,Comparison of Hilar Clamping Techniques in Partial Nephrectomy: Is Artery Only Clamping Beneficial?,"Hilar clamping is widely adopted in open partial nephrectomy, which is a treatment option for small renal cancer to reduce blood loss and improve surgical exposure, but whether to clamp either only artery or both artery and vein remains controversial. The purpose of this study is to determine whether artery only (AO) clamping is more beneficial than en bloc clamping by comparing perioperative variables in patients who underwent partial nephrectomy with either AO clamping or en bloc clamping. Eighty-eight patients with T1 renal tumor who underwent open partial nephrectomy with either AO or en bloc clamping between 2015 and 2018 at our institution were enrolled. They were randomly divided into two groups: AO group ( n  = 43) and artery and vein (AV) group ( n  = 45). Renal function was evaluated by serum creatinine (SCr) and differential renal function as determined by mercaptoacetyltriglycine renogram. AO clamping was associated with less total renal functional decrease until postoperative 7th day ( P  < 0.05). After postoperative 15th day, however, there was no significant difference in total renal functional impairment between AO and AV groups. There was also no significant difference in differential renal function change. Furthermore, AO clamping caused more blood loss and hemoglobin (Hb) decrease than en bloc clamping ( P  < 0.05). AO clamping is no more beneficial than en bloc clamping in partial nephrectomy, presenting with not significantly better long-term postoperative renal function than en bloc clamping.",2020,AO clamping was associated with less total renal functional decrease until postoperative 7th day ( P  < 0.05).,"['Partial Nephrectomy', 'Eighty-eight patients with T1 renal tumor who underwent open partial nephrectomy with either AO or en bloc clamping between 2015 and 2018 at our institution were enrolled', 'patients who underwent partial nephrectomy with either AO clamping or en bloc clamping']","['AO clamping', 'Hilar Clamping Techniques', 'artery only (AO) clamping']","['total renal functional', 'differential renal function change', 'serum creatinine (SCr) and differential renal function', 'total renal functional impairment', 'Renal function', 'blood loss and hemoglobin (Hb']","[{'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0430198', 'cui_str': 'Differential renal function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",88.0,0.0118631,AO clamping was associated with less total renal functional decrease until postoperative 7th day ( P  < 0.05).,"[{'ForeName': 'Kil-Hun', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': ""Urology Department, the Pyongyang Medical College, Kim Il Sung University, Ryonhwa-dong, Central District, Pyongyang, Democratic People's Republic of Korea.""}, {'ForeName': 'Wol-Song', 'Initials': 'WS', 'LastName': 'Jang', 'Affiliation': ""Urology Department, the Pyongyang Medical College, Kim Il Sung University, Ryonhwa-dong, Central District, Pyongyang, Democratic People's Republic of Korea.""}]",Indian journal of surgical oncology,['10.1007/s13193-020-01064-z'] 2678,32523292,"A comparative study of a new ""off-centre:off-centre"" technique of transtibial ACL reconstruction with ""centre:centre"" transportal ACL reconstruction.","Background & introduction A Single Bundle ACL Reconstruction aims at placing Tibial and Femoral attachment sites of graft from Centre of Native Tibial Foot-print to Centre of Native Femoral Footprint. In tibial tunnel independent Transportal Reconstruction, where the two points are chosen separately, the objective is easily achievable. In Tibial tunnel dependent Transtibial ACL reconstruction, Capture of Centre of femoral tunnel is dictated by Trajectory of Tibial Tunnel. Heming et al. remarked that a TT technique could produce tunnel centred in the both the tibial and femoral footprint but only if a starting point ""prohibitively close"" to the joint line with a correspondingly short tibial tunnel were used. A new technique wherein authors aim to place the mouths of Tibial & Femoral tunnel at off-centre location, taking care to contain these tunnels still within native footprints to achieve a tunnel which is of adequate length and does not come too close to the joint and saves MCL from violation. Objective To study the clinic-radiological outcome of a new ""Off-centre to Off-centre"" method of Transtibial Reconstruction and compare the results with ""centre to centre"" method of Transportal reconstruction. Methods A prospective randomised comparative study of consecutive 75 clinico-radiological cases of ACL tear with definitive clinical symptoms of knee instability who underwent arthroscopic ACL reconstruction by Same Arthroscopy Surgeon was conducted between 2016 and 2018. A modification, as described herein below, was used in Transtibial technique with placement of centre of mouth of internal opening of tibial tunnel ""off-centre"" that allowed a predictable capture of Femoral Footprint in ""off-centre"" location without tunnel being too close to joint line. Only those cases were included in which the mouths of tunnel were completely contained within footprints. Capture of footprints was verified during arthroscopy. 11 cases were excluded because either the native footprint was not clearly delineated, or surgeon failed to completely contain the mouth of tunnel/socket within the delineated footprint of tibia or femur. Hence 64 patients, 32 each in Transtibial & Transportal group were enrolled into the study. The results were analysed with the objective to arrive at recommendations for improving capture of anatomical footprints at both ends by Transtibial technique. Results There were no statistically significant differences in Clinical outcome scores. However there were statistically significant differences in length of Femoral Tunnel, Obliquity of Femoral tunnel as well as Femoral Tunnel Placements. Likewise, Tibial Tunnel Angle in AP & Lateral View as well as Tibial tunnel placement were also significantly different. Conclusion It is concluded that tunnels follow much different trajectories in the bones in two techniques and trying to apply ""Centre of Tibial footprint to Centre of Femoral footprint"" philosophy of Transportal technique may be imprudent for Transtibial Technique. An ""Off-centre to Off-centre but contained within Footprints"" may afford a more predictable and reliable capture of anatomical foot prints without any adverse effect on outcomes.",2020,"However there were statistically significant differences in length of Femoral Tunnel, Obliquity of Femoral tunnel as well as Femoral Tunnel Placements.","['11 cases were excluded because either the native footprint was not clearly delineated, or surgeon failed to completely contain the mouth of tunnel/socket within the delineated footprint of tibia or femur', 'Hence 64 patients, 32 each in Transtibial & Transportal group were enrolled into the study', 'consecutive 75 clinico-radiological cases of ACL tear with definitive clinical symptoms of knee instability who underwent arthroscopic ACL reconstruction by Same Arthroscopy Surgeon was conducted between 2016 and 2018', 'graft from Centre of Native Tibial Foot-print to Centre of Native Femoral Footprint']","[' & introduction\n\n\nA Single Bundle ACL Reconstruction', 'TT technique', 'new ""Off-centre to Off-centre"" method of Transtibial Reconstruction', 'transtibial ACL reconstruction with ""centre:centre"" transportal ACL reconstruction']","['Likewise, Tibial Tunnel Angle in AP & Lateral View as well as Tibial tunnel placement', 'length of Femoral Tunnel, Obliquity of Femoral tunnel as well as Femoral Tunnel Placements']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0427262', 'cui_str': 'Unstable knee'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",11.0,0.0203455,"However there were statistically significant differences in length of Femoral Tunnel, Obliquity of Femoral tunnel as well as Femoral Tunnel Placements.","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Manocha', 'Affiliation': 'Northern Railway Central Hospital New Delhi, India.'}, {'ForeName': 'I D', 'Initials': 'ID', 'LastName': 'Bhoumik', 'Affiliation': 'Northern Railway Central Hospital New Delhi, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Modi', 'Affiliation': 'Northern Railway Central Hospital New Delhi, India.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2020.02.009'] 2679,32523554,"Effects of a 6-Week Internet-Based Stress Management Program on Perceived Stress, Subjective Coping Skills, and Sleep Quality.","Occupational stress management intervention programs are known to be effective in preventing stress-related health burden. Two essential mechanisms underlie this effect: (i) a reduction in perceived stress (e.g., via relaxation-oriented techniques), and (ii) an improvement in coping skills (e.g., via cognitive-behavioral interventions). While relaxation-oriented interventions are more frequently employed in occupational settings, cognitive-behavioral stress management interventions reveal stronger effects on stress-related outcomes. As an effective and economic strategy, the dissemination of stress management programs via the internet is soaring, but most internet-based programs focus on relaxation or reducing perceived stress. In the present study, we examined the effects of a self-guided, cognitive-behavioral 6-week Internet-Based Stress Management (IBSM) program on perceived stress, coping skills, emotional exhaustion, depressive symptoms, and sleep quality. The IBSM consists of six modules focusing on the improvement of stress management skills such as dealing with acute stress, building up resources, or reappraising stress-facilitating cognitions. The participants have to work through the content on a weekly basis, requiring about 30 min per week followed by a transfer task lasting another 30 min. Healthy employees reporting elevated stress were recruited over the Internet and then randomly assigned to the IBSM group or a waiting list control group. A total of 134 participants completed all assessments before and after the training or waiting period. The IBSM group reported lower subjective stress levels after the program than the control group. In addition, the IBSM group exhibited improved coping skills and better sleep quality. Emotional exhaustion was reduced in both groups, while depressive symptoms did not change. These results suggest that a brief, 6-week, cognitive-behavioral internet-based stress management program improves coping skills, sleep quality, and well-being, and reduces the perceived stress of employees. Our results might encourage large-scale studies on the long-term stability and clinical efficacy of internet-based programs. The trial is registered in the German Clinical Trials Register (DRKS00014837) URL. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014837.",2020,"These results suggest that a brief, 6-week, cognitive-behavioral internet-based stress management program improves coping skills, sleep quality, and well-being, and reduces the perceived stress of employees.","['134 participants completed all assessments before and after the training or waiting period', 'Healthy employees reporting elevated stress']","['IBSM group or a waiting list control group', '6-Week Internet-Based Stress Management Program', 'self-guided, cognitive-behavioral 6-week Internet-Based Stress Management (IBSM) program', 'cognitive-behavioral internet-based stress management program', 'IBSM']","['coping skills and better sleep quality', 'Emotional exhaustion', 'subjective stress levels', 'coping skills, sleep quality, and well-being, and reduces the perceived stress of employees', 'perceived stress, coping skills, emotional exhaustion, depressive symptoms, and sleep quality', 'depressive symptoms', 'Perceived Stress, Subjective Coping Skills, and Sleep Quality']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",134.0,0.0198482,"These results suggest that a brief, 6-week, cognitive-behavioral internet-based stress management program improves coping skills, sleep quality, and well-being, and reduces the perceived stress of employees.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Stächele', 'Affiliation': 'Laboratory for Biological and Personality Psychology, Department of Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Biological and Clinical Psychology, University of Trier, Trier, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wekenborg', 'Affiliation': 'Department of Biological Psychology, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Penz', 'Affiliation': 'Department of Biological Psychology, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Kirschbaum', 'Affiliation': 'Department of Biological Psychology, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Laboratory for Biological and Personality Psychology, Department of Psychology, University of Freiburg, Freiburg, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00463'] 2680,32523556,Psychiatric Acute Day Hospital as an Alternative to Inpatient Treatment.,"For the first time in the Swiss health care system, this evaluation study examined whether patients with acute psychiatric illness who were admitted for inpatient treatment could be treated in an acute day hospital instead. The acute day hospital is characterized by the possibility of direct admission of patients without preliminary consultation or waiting time and is open every day of the week. In addition, it was examined whether and to what extent there are cost advantages for day hospital treatment. Patients who were admitted to the hospital with a referral to an inpatient admission were treated randomly either fully inpatient or in the acute day hospital. As a pilot study, 44 patients were admitted to the study. Evidence of efficacy could be provided for both treatment settings based on significant reduction in psychopathological symptoms and improvement in functional level in the course of treatment. There were no significant differences between the two settings in terms of external assessment of symptoms, subjective symptom burden, functional level, quality of life, treatment satisfaction, and number of treatment days. Treatment in the day hospital was about 45% cheaper compared to inpatient treatment. The results show that acutely ill psychiatric patients of different symptom severity can be treated just as well in an acute day hospital instead of being admitted to the hospital. In addition, when direct treatment costs are considered, there are clear cost advantages for day hospital treatment.",2020,"There were no significant differences between the two settings in terms of external assessment of symptoms, subjective symptom burden, functional level, quality of life, treatment satisfaction, and number of treatment days.","['Patients who were admitted to the hospital with a referral to an inpatient admission', 'acutely ill psychiatric patients', '44 patients were admitted to the study', 'patients with acute psychiatric illness who were admitted for inpatient treatment could be treated in an acute day hospital instead']",[],"['functional level', 'psychopathological symptoms', 'external assessment of symptoms, subjective symptom burden, functional level, quality of life, treatment satisfaction, and number of treatment days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",44.0,0.0181077,"There were no significant differences between the two settings in terms of external assessment of symptoms, subjective symptom burden, functional level, quality of life, treatment satisfaction, and number of treatment days.","[{'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Heekeren', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Habermeyer', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caitriona', 'Initials': 'C', 'LastName': 'Obermann', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kirschner', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Rössler', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Zurich, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00471'] 2681,32523648,An exploratory study of metformin with or without rapamycin as maintenance therapy after induction chemotherapy in patients with metastatic pancreatic adenocarcinoma.,"PURPOSE Metformin combined with the mTOR inhibitor rapamycin showed potential synergistic anti-tumor activity in preclinical studies in pancreatic ductal adenocarcinoma (PDA). This phase 1b study (NCT02048384) was conducted to evaluate the feasibility and activity of metformin +/- rapamycin in the maintenance setting for unselected patients with metastatic PDA (mPDA) treated with chemotherapy. MATERIALS AND METHODS Eligible patients with stable or responding mPDA after ≥ 6 months on chemotherapy were randomized 1:1 to metformin alone (Arm A) or with rapamycin (Arm B), stratified by prior treatment with FOLFIRINOX. Fluorodeoxyglucose (FDG) PET scans and peripheral blood mononuclear cells were obtained for exploratory analyses. RESULTS 22 subjects (11 per arm) received treatment per protocol. Median PFS/OS were 3.5 and 13.2 months respectively, with 2 year OS rate of 37%; there were no differences between arms. No responses were observed by RECIST; however, decreases in FDG avidity and/or CA19-9 were observed in several long-term survivors. Treatment related adverse events of Grade ≥ 3 occurred in 0% vs 27% of patients in Arm A vs B and were asymptomatic hematologic or electrolyte abnormalities that were not clinically significant. Improved survival was associated with low baseline neutrophil: lymphocyte ratio, baseline lack of assessable disease by PET, and greater expansion of dendritic cells following treatment. CONCLUSIONS Metformin +/- rapamycin maintenance for mPDA was well-tolerated and several patients achieved stable disease associated with exceptionally long survival. Further prospective studies are needed to clarify the role of these agents in the maintenance setting and to enhance patient selection for such approaches.",2020,"No responses were observed by RECIST; however, decreases in FDG avidity","['unselected patients with metastatic PDA (mPDA) treated with chemotherapy', 'patients with metastatic pancreatic adenocarcinoma', 'pancreatic ductal adenocarcinoma (PDA', 'Eligible patients with stable or responding mPDA after ≥ 6 months on chemotherapy']","['Metformin', 'metformin ', 'rapamycin', 'mTOR inhibitor rapamycin', 'metformin alone (Arm A) or with rapamycin', 'Metformin ', 'metformin with or without rapamycin', 'Fluorodeoxyglucose (FDG']","['PET scans and peripheral blood mononuclear cells', 'adverse events of Grade ≥ 3', 'FDG avidity', 'asymptomatic hematologic or electrolyte abnormalities', 'Improved survival', 'Median PFS/OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0634473', 'cui_str': ""3-(2'-pyridyldithio)benzyldiazoacetate""}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}]","[{'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0241209,"No responses were observed by RECIST; however, decreases in FDG avidity","[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bever', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Erkut H', 'Initials': 'EH', 'LastName': 'Borazanci', 'Affiliation': 'Virginia Piper Cancer Center at HonorHealth, Scottsdale, AZ, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pinero', 'Affiliation': 'Virginia Piper Cancer Center at HonorHealth, Scottsdale, AZ, USA.'}, {'ForeName': 'Gayle S', 'Initials': 'GS', 'LastName': 'Jameson', 'Affiliation': 'Virginia Piper Cancer Center at HonorHealth, Scottsdale, AZ, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Vrana', 'Affiliation': 'Virginia Piper Cancer Center at HonorHealth, Scottsdale, AZ, USA.'}, {'ForeName': 'Meizheng', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Wilt', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Yafu', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Nuclear Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai City, China.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Leal', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Ana De', 'Initials': 'A', 'LastName': 'Jesus-Acosta', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Von Hoff', 'Affiliation': 'Virginia Piper Cancer Center at HonorHealth, Scottsdale, AZ, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Powell', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}]",Oncotarget,['10.18632/oncotarget.27586'] 2682,32523721,"Effects of a novel combination of orlistat and acarbose on tolerability, appetite, and glucose metabolism in persons with obesity.","Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m -2 or BMIs 30 to 32 kg m -2 and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.",2020,"In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group.","['persons with obesity', 'Methods\n\n\nSixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m -2 or BMIs 30 to 32 kg m -2 and waist circumference above 102 cm were included']","['conventional orlistat (CO', 'orlistat and acarbose', 'formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat', 'orlistat and acarbose (MR-OA']","['hunger', 'postprandial plasma glucose concentration', 'appetite and reduces postprandial glucose', 'faecal incontinence', 'gastric distension and flatulence', 'tolerability', 'tolerability, appetite, and glucose metabolism', 'Tolerability', 'tolerability, appetite and glucose metabolism']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0732649', 'cui_str': 'Xenical'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",67.0,0.050229,"In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group.","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Holmbäck', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism Uppsala University Uppsala Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Forslund', 'Affiliation': ""Department of Women's and Children's Health Uppsala University Uppsala Sweden.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Grudén', 'Affiliation': 'Empros Pharma AB Solna Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Alderborn', 'Affiliation': 'Department of Pharmacy Uppsala University Uppsala Sweden.'}, {'ForeName': 'Arvid', 'Initials': 'A', 'LastName': 'Söderhäll', 'Affiliation': 'Empros Pharma AB Solna Sweden.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Hellström', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lennernäs', 'Affiliation': 'Department of Pharmacy Uppsala University Uppsala Sweden.'}]",Obesity science & practice,['10.1002/osp4.405'] 2683,32523724,School health education program in Pakistan (SHEPP)-a threefold health education feasibility trial in schoolchildren from a lower-middle-income country.,"Background The school environment plays an essential role in promoting health education and physical activity for children and adolescence, and they are more likely to adapt it into their adulthood. School health education program has been endorsed and emphasized by the World Health Organization has not been implemented in true spirit in Pakistan yet. We aim to test feasibility of threefold health education program in children and its potential efficacy on physical activity and diet and cardiometabolic risk factors by including BP, BMI, and waist circumference. Methods It is a parallel-group feasibility intervention trial. It is being conducted in two schools from lower to middle-income areas, at different locations but having the same school curriculum under the Aga Khan Education Service, Pakistan (AKESP). All children aged 9-11 years enrolled from the schools mentioned above were included. Children with any physical disability were excluded. One school received threefold intervention (focused on children, parents, and teachers) of school health education program in Pakistan (SHEPP) while the other school continued routine activity. Intervention of SHEPP is directed towards educating children, parents, and teachers about healthy behaviors. Children will receive interactive educational sessions and specially designed physical activity sessions. A 3-h health education session focusing on same healthy behaviors as for children will be conducted for both parents and teachers. Primary outcome is feasibility of SHEPP in terms of recruitment, retention, and treatment fidelity. Secondary outcomes are physical activity levels, dietary intake (of fruits, vegetable), and cardiometabolic risk factors (blood pressure, BMI, and waist circumference (WC)). The total number of children recruited were 982 (82.5 %); 505 from school A and 477 from school B and 496 (50.5) were boys. Conclusion SHEPP is a unique health education program for children as it focuses on children while involving the parents and teachers in the behavior change process. If found feasible and demonstrating potential efficacy on physical activity, dietary behaviors, and cardiometabolic parameters, we will be able to replicate this on a larger scale in public sector schools also. Trial registration NCT03303287.",2020,"The total number of children recruited were 982 (82.5 %); 505 from school A and 477 from school B and 496 (50.5) were boys. ","['total number of children recruited were 982 (82.5 %); 505 from school A and 477 from school B and 496 (50.5) were boys', 'All children aged 9-11\u2009years enrolled from the schools mentioned above were included', 'School health education program in Pakistan (SHEPP)-a threefold health education feasibility trial in schoolchildren from a lower-middle-income country', 'Children with any physical disability were excluded', 'two schools from lower to middle-income areas, at different locations but having the same school curriculum under the Aga Khan Education Service, Pakistan (AKESP']","['SHEPP', 'threefold health education program', 'interactive educational sessions and specially designed physical activity sessions', 'school health education program in Pakistan (SHEPP']","['BP, BMI, and waist circumference', 'physical activity levels, dietary intake (of fruits, vegetable), and cardiometabolic risk factors (blood pressure, BMI, and waist circumference (WC', 'physical activity, dietary behaviors, and cardiometabolic parameters', 'feasibility of SHEPP in terms of recruitment, retention, and treatment fidelity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036372', 'cui_str': 'Nursing, School'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0235881,"The total number of children recruited were 982 (82.5 %); 505 from school A and 477 from school B and 496 (50.5) were boys. ","[{'ForeName': 'Aysha', 'Initials': 'A', 'LastName': 'Almas', 'Affiliation': 'Department of Medicine, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Romaina', 'Initials': 'R', 'LastName': 'Iqbal', 'Affiliation': 'Department of Medicine and Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Sabir', 'Affiliation': 'Department of Medicine, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Ghani', 'Affiliation': 'Department of Medicine and Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Khawar', 'Initials': 'K', 'LastName': 'Kazmi', 'Affiliation': 'National Institute of Cardiovascular Diseases, Karachi, Pakistan.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00625-x'] 2684,32523793,"Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial.","There have been many studies suggesting that probiotics are effective in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). However, its mechanism of action as well as prediction of response is still to be elucidated. In the present study, to find out metabolomic characteristics of probiotic effect in IBS-D, we compared IBS symptom changes and metabolomic characteristics in the subjects' urine samples between multi-strain probiotics (one strain of Lactobacillus sp. and four strains of Bifidobacterium sp.) group (n = 32) and placebo group (n = 31). After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved. Also, probiotics group had significantly changed seven metabolites including palmitic acid methyl ester (PAME) and 4,6-dihydroxyquinoline, 4-(2-aminophenyl)-2,4-dioxobutanoic acid (DOBA). According to IBS-SSS and IBS-QoL questionnaires, IBS-SSS responders showed higher PAME levels and IBS-QoL responders showed lower DOBA levels. This suggests potential role of these metabolites as a biomarker to predict probiotics effect in IBS-D patients.",2020,"After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved.",['patients with diarrhea-predominant irritable bowel syndrome (IBS-D'],"['Probiotic treatment', 'placebo']","['palmitic acid methyl ester (PAME) and 4,6-dihydroxyquinoline, 4-(2-aminophenyl)-2,4-dioxobutanoic acid (DOBA', 'dissatisfaction in bowel habits and stool frequencies', 'inflammation related metabolites', 'DOBA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0066275', 'cui_str': 'methyl palmitate'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.131296,"After 8 weeks' administration (3 times/day), dissatisfaction in bowel habits and stool frequencies were significantly improved.","[{'ForeName': 'Jinjoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Kumsun', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Joo Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Hyun Chae', 'Initials': 'HC', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Bumsik', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Food and Nutrition, Yeonsung University, Anyang, Gyeonggi 14011 Republic of Korea.'}, {'ForeName': 'Myeong Soo', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Bifodo Co., Hongcheon, Gangwon 25117 Republic of Korea.'}, {'ForeName': 'Geun Eog', 'Initials': 'GE', 'LastName': 'Ji', 'Affiliation': 'Bifodo Co., Hongcheon, Gangwon 25117 Republic of Korea.'}, {'ForeName': 'Joo-Youn', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, 03080 Republic of Korea.'}, {'ForeName': 'Kyoung Sup', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Gastroenterology, Mediplex Sejong Hospital, 20, Gyeyangmunhwa-ro, Gyeyang-gu, Incheon, 21080 Republic of Korea.'}]",Food science and biotechnology,['10.1007/s10068-019-00717-2'] 2685,32523825,Evaluation of the Effects of Preoperative Dexamethasone Administration on Postoperative Patient Comfort in Laparoscopic Cholecystectomy.,"Objective Postoperative recovery process following laparoscopic cholecystectomy depends on many factors such as pain, fatigue and exhaustion. The objective of this study was to investigate whether the administration of dexamethasone, a glucocorticoid, has positive effects of postoperative patient comfort in patients who underwent laparoscopic cholecystectomy in our clinic. Methods Patients who presented to the general surgery clinic of our hospital and scheduled for laparoscopic cholecystectomy due to cholelithiasis were included in this study. Patients in Group 1 received dexamethasone 90 minutes before the skin incision, while patients in Group 2 were given placebo (normal saline). Pain scores, presence of nausea and vomiting in the postoperative period were compared between the study and control groups. Results No statistically significant difference was observed between the groups in terms of incisional pain at rest and in motion and visceral pain at rest at postoperative 6th, 12th and 24th hours. Although there was a difference between the groups in terms of visceral pain in motion at the postoperative 12th and 24th hours, this was not statistically significant (p > 0.05). Although the need for additional analgesics and antiemetic drugs was lower in the study group compared to the control group, the difference between the groups was not statistically significant (p > 0.05). Conclusion We can expect better results with the use of multimodal analgesic and anti-emetic combination instead of a single agent in studies to be performed about the prevention of postoperative pain, nausea and vomiting.",2020,"No statistically significant difference was observed between the groups in terms of incisional pain at rest and in motion and visceral pain at rest at postoperative 6th, 12th and 24th hours.","['Laparoscopic Cholecystectomy', 'Methods Patients who presented to the general surgery clinic of our hospital and scheduled for laparoscopic cholecystectomy due to cholelithiasis were included in this study', 'patients who underwent laparoscopic cholecystectomy in our clinic']","['dexamethasone', 'Preoperative Dexamethasone Administration', 'placebo (normal saline', 'laparoscopic cholecystectomy']","['Pain scores, presence of nausea and vomiting', 'visceral pain', 'postoperative pain, nausea and vomiting', 'Postoperative Patient Comfort', 'incisional pain at rest and in motion and visceral pain', 'pain, fatigue and exhaustion']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.053964,"No statistically significant difference was observed between the groups in terms of incisional pain at rest and in motion and visceral pain at rest at postoperative 6th, 12th and 24th hours.","[{'ForeName': 'Gungor', 'Initials': 'G', 'LastName': 'Gul', 'Affiliation': 'General Surgery, Private Goztepe Hospital, Istanbul, TUR.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Bilgic', 'Affiliation': 'Medical Service and Techniques, Nisantasi University Vocational High School, Istanbul, TUR.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Aydin', 'Affiliation': 'General Surgery, Altinbas University Faculty of Medicine, Medical Park Bahcelievler Hospital, Istanbul, TUR.'}]",Cureus,['10.7759/cureus.7968'] 2686,32523885,Effects of conjugated linoleic acid supplementation on serum levels of interleukin-6 and sirtuin 1 in COPD patients.,"Objective Chronic obstructive pulmonary disease (COPD) is characterized by systemic inflammation and accelerated inflammaging of the lungs. Some studies showed that conjugated linoleic acid (CLA) has anti-inflammatory effects. The aim of the present study was to evaluate the effect of CLA supplementation on serum levels of interleukin (IL)-6 and sirtuin1 (SIRT1) in patients with COPD. Materials and Methods 82 patients with stable COPD were enrolled in a double blind clinical trial. Subjects were randomly assigned to two groups: placebo (n=42) and 3.2 g CLA daily supplementation (n=40). Forced expiratory volume in one second (FEV1%), BODE index, and serum levels of IL-6, and SIRT1 were measured at the baseline and six weeks after the intervention. In addition, the study parameters in the two groups were compared based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Results After supplementation with CLA, serum levels of IL-6 and BODE index significantly decreased (p<0.05 and p<0.001, respectively). In addition, serum levels of SIRT1 (p<0.01) and FEV1 (p<0.001) significantly increased in the supplementation group. Based on GOLD criteria, the increase in SIRT1 and the decrease in IL-6 serum levels were found to be statistically significant in stages III and IV in the supplementation group (p<0.05 and p<0.01, respectively). Conclusion Supplementation with CLA can modify the inflammatory markers and improve the health status of COPD patients. The results suggest that CLA supplementation in COPD patients can be useful in the management of the disease.",2020,"After supplementation with CLA, serum levels of IL-6 and BODE index significantly decreased (p<0.05 and p<0.001, respectively).","['Objective\n\n\nChronic obstructive pulmonary disease (COPD', 'patients with COPD', 'COPD patients', '82 patients with stable COPD']","['conjugated linoleic acid supplementation', 'CLA supplementation', 'CLA', 'CLA daily supplementation', 'conjugated linoleic acid (CLA', 'placebo']","['serum levels of interleukin (IL)-6 and sirtuin1 (SIRT1', 'IL-6 serum levels', 'serum levels of IL-6 and BODE index', 'Forced expiratory volume in one second (FEV1%), BODE index, and serum levels of IL-6, and SIRT1', 'serum levels of interleukin-6 and sirtuin 1', 'serum levels of SIRT1 (p<0.01) and FEV1']","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}]",82.0,0.281374,"After supplementation with CLA, serum levels of IL-6 and BODE index significantly decreased (p<0.05 and p<0.001, respectively).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Aslani', 'Affiliation': 'Lung Inflammatory Diseases Research Center, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Somaieh', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nemati', 'Affiliation': 'Biochemistry and Nutrition Department, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Mesgari-Abbasi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Ghorbani', 'Affiliation': 'Medical student, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ghobadi', 'Affiliation': 'Internal Medicine Department (Pulmonary Division), Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}]",Avicenna journal of phytomedicine,[] 2687,32523972,"Efficacy of Bezlotoxumab in Participants Receiving Metronidazole, Vancomycin, or Fidaxomicin for Treatment of Clostridioides ( Clostridium ) difficile Infection.","Background In phase 3 MODIFY I/II trials, bezlotoxumab significantly reduced recurrence of Clostridioides ( Clostridium ) difficile infection (rCDI) over 12 weeks. Choice of CDI antibacterial treatment may affect CDI-related outcomes; therefore, this prespecified analysis assessed if the magnitude of bezlotoxumab-induced rCDI reduction was influenced by the antibiotic administered. Methods In MODIFY I/II (NCT01241552/NCT01513239), participants received a single infusion of bezlotoxumab (10 mg/kg) or placebo during anti-CDI treatment. Using pooled data from MODIFY I/II, initial clinical cure (ICC) and rCDI were assessed in metronidazole-, vancomycin-, and fidaxomicin-treated subgroups. Results Of 1554 participants in MODIFY I/II, 753 (48.5%) received metronidazole, 745 (47.9%) vancomycin, and 56 (3.6%) fidaxomicin. Fewer participants receiving metronidazole had a prior CDI episode in the previous 6 months (12.9%) or ≥1 risk factor for rCDI (66.0%) vs participants receiving vancomycin (41.2% and 83.6%, respectively) and fidaxomicin (55.4% and 89.3%, respectively). ICC rates were similar in the bezlotoxumab (metronidazole, 81.0%; vancomycin, 78.5%; fidaxomicin, 86.7%) and placebo groups (metronidazole, 81.3%; vancomycin, 79.6%; fidaxomicin, 76.9%). In placebo-treated participants, the rCDI was lower in the metronidazole subgroup vs the vancomycin and fidaxomicin subgroups (metronidazole, 28.0%; vancomycin, 38.4%; fidaxomicin, 35.0%). When analyzed by subsets based on history of CDI, rCDI rates were similar in the metronidazole and vancomycin groups. rCDI rates were lower in all antibiotic subgroups for bezlotoxumab vs placebo (metronidazole: rate difference [RD], -9.7%; 95% confidence interval [CI], -16.4% to -3.1%; vancomycin: RD, -15.4%; 95% CI, -22.7% to -8.0%; fidaxomicin: RD, -11.9%; 95% CI, -38.1% to 14.3%). Conclusion Bezlotoxumab reduces rCDI vs placebo in participants receiving metronidazole and vancomycin, with a similar effect size in participants receiving fidaxomicin.",2020,"In placebo-treated participants, the rCDI was lower in the metronidazole subgroup vs the vancomycin and fidaxomicin subgroups (metronidazole, 28.0%; vancomycin, 38.4%; fidaxomicin, 35.0%).","['Participants Receiving', 'participants receiving fidaxomicin', 'participants receiving', '1554 participants in MODIFY']","['metronidazole and vancomycin', 'Metronidazole, Vancomycin, or Fidaxomicin', 'vancomycin', 'fidaxomicin', 'bezlotoxumab (metronidazole', 'bezlotoxumab vs placebo (metronidazole', 'bezlotoxumab', 'metronidazole', 'Bezlotoxumab', 'placebo']","['rCDI rates', 'ICC rates', 'recurrence of', 'history of CDI, rCDI rates', 'initial clinical cure (ICC) and rCDI', 'fidaxomicin', 'rCDI', 'rCDI reduction']","[{'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}, {'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",1554.0,0.407997,"In placebo-treated participants, the rCDI was lower in the metronidazole subgroup vs the vancomycin and fidaxomicin subgroups (metronidazole, 28.0%; vancomycin, 38.4%; fidaxomicin, 35.0%).","[{'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Dubberke', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Edward Hines, Jr. VA Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Ciarán P', 'Initials': 'CP', 'LastName': 'Kelly', 'Affiliation': 'BIDMC & Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Garey', 'Affiliation': 'University of Houston College of Pharmacy, Houston, Texas, USA.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Rahav', 'Affiliation': 'Sheba Medical Center and The Sackler Faculty of Medicine, Tel Hashomer, Israel.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Mosley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tipping', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa157'] 2688,32524033,Retinal arteriolar oxygen saturation predicts the need for intravitreal aflibercept in patients with diabetic macular oedema.,"Objective Given the increasing burden of repetitive intravitreal injections in diabetic macular oedema (DMO) treatment, non-invasive markers of treatment outcome are needed. Hence, we aimed to examine retinal oximetry parameters as markers of need for intravitreal aflibercept in patients with DMO. Methods This study was based on data from a 12-month clinical trial including 35 eyes of 25 patients with centre involving DMO. Retinal oximetry, visual acuity (VA) and central retinal thickness (CRT) were performed at baseline (BL). Patients then received 3 monthly injections of aflibercept followed by focal/grid laser photocoagulation. From month 4 (M4) through 12 (M12), patients were followed monthly and additional injections were given pro re nata if criteria of retreatment were met. We evaluated the difference in need for intravitreal aflibercept in groups of eyes with the highest and lowest retinal arteriolar and venular oxygen saturations, respectively. Results From BL-M12, overall VA letter score improved by 8.7 (7.2-10.2). Likewise CRT reduced by 100.7 (68.2-133.3) µm and the mean number of injections was 4.3 (3.8-4.8). Overall retinal arteriolar and venular oxygen saturations were 95.7 (93.0-98.4)% and 62.7 (59.4-65.9)% at BL. Eyes with the highest retinal arteriolar oxygen saturations had significantly more injections between BL and M12 compared with eyes with the lowest retinal arteriolar oxygen saturations (5.0 (4.2-5.8) vs 3.6 (3.1-4.0), p=0.002). Conclusion Higher retinal arteriolar oxygen saturation independently predicted the need for more intravitreal aflibercept during the first year of DMO treatment and may serve as a valuable adjunctive to established procedures for retinal imaging in terms of individualised treatment plans. Trial registration number NCT02554747.",2020,Likewise CRT reduced by 100.7 (68.2-133.3) µm and the mean number of injections was 4.3 (3.8-4.8).,"['35 eyes of 25 patients with centre involving DMO', 'patients with diabetic macular oedema', 'patients with DMO', 'diabetic macular oedema (DMO']","['Retinal arteriolar oxygen saturation', 'intravitreal aflibercept', 'aflibercept followed by focal/grid laser photocoagulation']","['Retinal oximetry, visual acuity (VA) and central retinal thickness (CRT', 'retinal arteriolar oxygen saturation', 'retinal arteriolar oxygen saturations', 'Overall retinal arteriolar and venular oxygen saturations', 'overall VA letter score', 'Likewise CRT']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.0890123,Likewise CRT reduced by 100.7 (68.2-133.3) µm and the mean number of injections was 4.3 (3.8-4.8).,"[{'ForeName': 'Søren Leer', 'Initials': 'SL', 'LastName': 'Blindbæk', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Grauslund', 'Affiliation': 'Department of Ophthalmology, Odense University Hospital, Odense, Denmark.'}]",BMJ open ophthalmology,['10.1136/bmjophth-2019-000382'] 2689,32524048,Open-label long-term treatment of add-on triheptanoin in adults with drug-resistant epilepsy.,"Objective To investigate feasibility, safety, and tolerability of long-term (48 weeks) add-on treatment with triheptanoin (UX007), the triglyceride of heptanoate, in adults with drug-resistant epilepsy. Methods This extension study was offered to adult participants with drug-resistant epilepsy who completed a 12-week randomized controlled trial of add-on medium-chain triglycerides (MCT) vs triheptanoin. Participants were asked to titrate triheptanoin to their maximum tolerated dose over 3 weeks, followed by 48-week maintenance before tapering or treatment extension. The primary aims were to assess retention and safety of the triheptanoin treatment, and secondary aims to assess the tolerated doses and changes in seizure frequency. Results Eleven adults were enrolled and ten people were analyzed (because one patient was diagnosed as having nonepileptic seizures while on the study). Two adults finished the study and extended their treatment. Eight participants withdrew from the study, due to lack of efficacy (n = 3), unknown reasons (n = 2), belief of weight gain (n = 1), wanting to try a different treatment (n = 1), and a colonoscopy (n = 1). Diarrhea in two people and bloating in one person were deemed possibly related to treatment, but other adverse events were not. The duration of maintenance treatment dose was 27-513 days (median 247 days, range 27-513 days), and 0.49 -1.1 mL/kg triheptanoin was taken per day (0.77 ± 0.19 mL/kg, mean ± standard deviation, 40-100 mL/d). Two participants experienced >90% and three people >50% reduction in seizure frequency, and all had focal seizures. The median seizure reduction was 48% (average 38%). Significance Our results indicate antiseizure effects of triheptanoin on focal seizures in 5 out of 10 adults. However, only two people finished and extended the 48-week add-on treatment phase, despite lack of safety or tolerability issues.More studies focused on improved treatment formulations, the potential of lower dosages, and efficacy are needed. Trial registration number: ACTRN12615000406505.",2020,"The duration of maintenance treatment dose was 27-513 days (median 247 days, range 27-513 days), and 0.49 -1.1 ","['5 out of 10 adults', 'adult participants with drug-resistant epilepsy', 'adults with drug-resistant epilepsy', 'Eleven adults were enrolled and ten people were analyzed (because one patient was diagnosed as having nonepileptic seizures while on the study', 'Eight participants withdrew from the study, due to lack of efficacy (n\xa0=\xa03), unknown reasons (n\xa0=\xa02), belief of weight gain (n\xa0=\xa01), wanting to try a different treatment (n\xa0=\xa01), and a colonoscopy (n\xa0=\xa01']","['mL/kg triheptanoin', 'Open-label long-term treatment of add-on triheptanoin', 'medium-chain triglycerides (MCT) vs triheptanoin', 'triheptanoin (UX007', 'triheptanoin']","['median seizure reduction', 'seizure frequency', 'feasibility, safety, and tolerability', 'retention and safety', 'bloating', 'Diarrhea', 'tolerated doses and changes in seizure frequency', 'focal seizures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3495874', 'cui_str': 'Non-Epileptic Seizures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]",11.0,0.180051,"The duration of maintenance treatment dose was 27-513 days (median 247 days, range 27-513 days), and 0.49 -1.1 ","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Borges', 'Affiliation': 'School of Biomedical Sciences Faculty of Medicine The University of Queensland St. Lucia QLD Australia.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Kaul', 'Affiliation': 'Department of Allied Health (Clinical Nutrition) Royal Melbourne Hospital University of Melbourne Parkville Vic Australia.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Germaine', 'Affiliation': 'Departments of Neuroscience and Neurology The Central Clinical School Monash University and The Alfred Hospital Melbourne Vic Australia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Carrasco-Pozo', 'Affiliation': 'Discovery Biology Griffith Institute for Drug Discovery Griffith University Nathan QLD Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kwan', 'Affiliation': 'Departments of Medicine and Neurology Royal Melbourne Hospital University of Melbourne Parkville Vic Australia.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Medicine and Neurology Royal Melbourne Hospital University of Melbourne Parkville Vic Australia.'}]",Epilepsia open,['10.1002/epi4.12391'] 2690,32529206,Effects of oily fish intake on cognitive and socioemotional function in healthy 8-9-year-old children: the FiSK Junior randomized trial.,"BACKGROUND Long-chain n-3 PUFAs (n-3 LCPUFAs) accrete in the brain during childhood and affect brain development. Randomized trials in children show inconsistent effects of n-3 LCPUFAs on cognitive and socioemotional function, and few have investigated effects of fish per se. OBJECTIVES We aimed to investigate the effects of oily fish consumption on overall and domain-specific cognitive and socioemotional scores and explore sex differences. METHODS Healthy 8-9-y-old children (n = 199) were randomly allocated to receive ∼300 g/wk oily fish or poultry (control) for 12 ± 2 wk. At baseline and endpoint, we assessed attention, processing speed, executive functions, memory, emotions, and behavior with a large battery of tests and questionnaires and analyzed erythrocyte fatty acid composition. RESULTS One hundred and ninety-seven (99%) children completed the trial. Children in the fish group consumed 375 (25th-75th percentile: 325-426) g/wk oily fish resulting in 2.3 (95% CI: 1.9, 2.6) fatty acid percentage points higher erythrocyte n-3 LCPUFA than in the poultry group. The overall cognitive performance score tended to improve by 0.17 (95% CI: -0.01, 0.35) points in children who received fish compared with poultry, supported by n-3 LCPUFA dose dependency. This was driven mainly by fewer errors [-1.9 (95% CI: -3.4, -0.3)] in an attention task and improved cognitive flexibility measured as faster reaction time [-51 ms (95% CI: -94, -7 ms)] in a complex relative to a simple task (""mixing cost""). The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89 (95% CI: -1.60, -0.18) points mainly due to a -0.63 (95% CI: -1.11, -0.16) points reduction in internalizing problems that was reflected in tendency to a decrease in the overall socioemotional problems score of -0.13 (95% CI: -0.26, 0.01) points. The overall effects were similar in boys and girls. CONCLUSIONS Oily fish dose-dependently improved cognitive function, especially attention and cognitive flexibility, and reduced socioemotional problems. The results support the importance of n-3 LCPUFAs for optimal brain function and fish intake recommendations in children.The trial was registered at www.clinicaltrials.gov as NCT02809508.",2020,The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89,"['One hundred and ninety-seven (99%) children completed the trial', 'Healthy 8-9-y-old children (n\xa0=\xa0199', 'healthy 8-9-year-old children', 'children']","['n-3 LCPUFA', 'n-3 LCPUFAs', 'oily fish intake', 'oily fish consumption', '∼300 g/wk oily fish or poultry (control']","['overall and domain-specific cognitive and socioemotional scores and explore sex differences', 'overall effects', 'attention task and improved cognitive flexibility', 'reaction time ', 'cognitive function, especially attention and cognitive flexibility, and reduced socioemotional problems', 'overall cognitive performance score', 'cognitive and socioemotional function', 'attention, processing speed, executive functions, memory, emotions, and behavior with a large battery of tests and questionnaires and analyzed erythrocyte fatty acid composition', 'parent-rated Strength and Difficulties Questionnaire total difficulties', 'overall socioemotional problems score']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0556218', 'cui_str': 'Fatty fish intake'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0032850', 'cui_str': 'Fowls, Domestic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036866', 'cui_str': 'Sex Differences'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",199.0,0.37571,The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89,"[{'ForeName': 'Marie N', 'Initials': 'MN', 'LastName': 'Teisen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Vuholm', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Niclasen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Aristizabal-Henao', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Ken D', 'Initials': 'KD', 'LastName': 'Stark', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Svend S', 'Initials': 'SS', 'LastName': 'Geertsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla T', 'Initials': 'CT', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Lauritzen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa050'] 2691,32529343,Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer.,"PURPOSE The diagnosis and treatment of cancer negatively affect patients' physical, functional and psychological wellbeing. Patients' needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics. METHODS 113 patients with stage I-IIIB breast cancer treated with chemotherapy were included in this randomized controlled trial. Patients were randomly allocated to receive either usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit. Patients completed questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication. From the 2nd visit onwards, patients in the intervention arm and their HCPs received a copy of the QoL overview and results were shown in patients' medical files. Audio-recordings and patients' self-reports were used to investigate effects on communication, patient management and patient-wellbeing. A composite score for communication was calculated by summing the number of QoL-topics discussed during each consultation. RESULTS Use of the QoL-monitor resulted in a higher communication score (0.7 topics increase per visit, p = 0.04), especially regarding the disease-specific and psychosocial issues (p < 0.01). There were no differences in patient management, QoL, illness perceptions or distress. Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05). CONCLUSIONS Use of a QoL-monitor during chemotherapy in patients with early breast cancer might result in a more frequent discussion of QoL-topics, associated with high levels of patients' satisfaction.",2020,"Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05). ","['Dutch patients with early breast cancer', 'patients with early breast cancer', '113 patients with stage I-IIIB breast cancer treated with']","['chemotherapy', 'usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit']","['disease-specific and psychosocial issues', 'satisfaction with communication', 'higher communication score', 'questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication', 'patient management, QoL, illness perceptions or distress']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",113.0,0.0328797,"Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05). ","[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Lugtenberg', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. r.t.lugtenberg@lumc.nl.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Fischer', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Jongh', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Saitama International Medical Center, Saitama, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Matsuda', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University Graduate School of Public Health, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Nippon Medical School, Saitama, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Weijl', 'Affiliation': 'Department of Medical Oncology, HMC Bronovo Hospital, The Hague, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University Graduate School of Public Health, Tokyo, Japan.'}, {'ForeName': 'S R S', 'Initials': 'SRS', 'LastName': 'Ramai', 'Affiliation': 'Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Kaptein', 'Affiliation': 'Department of Medical Psychology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02549-8'] 2692,32529506,Left atrial mechanics and aortic stiffness following high intensity interval training: a randomised controlled study.,"PURPOSE High intensity interval training (HIIT) has been shown to improve important health parameters, including aerobic capacity, blood pressure, cardiac autonomic modulation and left ventricular (LV) mechanics. However, adaptations in left atrial (LA) mechanics and aortic stiffness remain unclear. METHODS Forty-one physically inactive males and females were recruited. Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20). The HIIT protocol consisted of 3 × 30-s maximal cycle ergometer sprints with a resistance of 7.5% body weight, interspersed with 2-min of active unloaded recovery, three times per week. Speckle tracking imaging of the LA and M-Mode tracing of the aorta was performed pre and post HIIT and control period. RESULTS Following HIIT, there was significant improvement in LA mechanics, including LA reservoir (13.9 ± 13.4%, p = 0.033), LA conduit (8.9 ± 11.2%, p = 0.023) and LA contractile (5 ± 4.5%, p = 0.044) mechanics compared to the control condition. In addition, aortic distensibility (2.1 ± 2.7 cm 2  dyn -1  10 3 , p = 0.031) and aortic stiffness index (- 2.6 ± 4.6, p = 0.041) were improved compared to the control condition. In stepwise linear regression analysis, aortic distensibility change was significantly associated with LA stiffness change R 2 of 0.613 (p = 0.002). CONCLUSION A short-term programme of HIIT was associated with a significant improvement in LA mechanics and aortic stiffness. These adaptations may have important health implications and contribute to the improved LV diastolic and systolic mechanics, aerobic capacity and blood pressure previously documented following HIIT.",2020,Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20).,['Forty-one physically inactive males and females were recruited'],"['HIIT', 'High intensity interval training (HIIT', '4-week HIIT intervention (n\u2009=\u200921) or 4-week control period', '3\u2009×\u200930-s maximal cycle ergometer sprints', 'high intensity interval training']","['LA mechanics, including LA reservoir', 'aortic stiffness index', 'LA conduit', 'aortic distensibility', 'LA contractile', 'aortic distensibility change', 'aerobic capacity, blood pressure, cardiac autonomic modulation and left ventricular (LV) mechanics', 'LV diastolic and systolic mechanics, aerobic capacity and blood pressure', 'Left atrial mechanics and aortic stiffness', 'LA mechanics and aortic stiffness']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",41.0,0.0203641,Participants were randomised to either a 4-week HIIT intervention (n = 21) or 4-week control period (n = 20).,"[{'ForeName': 'Navazh', 'Initials': 'N', 'LastName': 'Jalaludeen', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Bull', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Katrina A', 'Initials': 'KA', 'LastName': 'Taylor', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Wiles', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Damian A', 'Initials': 'DA', 'LastName': 'Coleman', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Howland', 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mukhtar', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': ""Department of Cardiology, St George's Healthcare NHS Trust, Blackshaw Road, Tooting, London, UK.""}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': ""O'Driscoll"", 'Affiliation': 'School of Human and Life Sciences, Canterbury Christ Church University, Kent, CT1 1QU, UK. jamie.odriscoll@canterbury.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-020-04416-3'] 2693,32529563,Biofeedback versus electrical stimulation for sexual dysfunction: a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS Sexual dysfunction is a common problem in the general population. We compared the effects of biofeedback and electrical stimulation on the symptoms of sexual pain dysfunction in women with urinary stress incontinence. METHODS We carried out a parallel randomized clinical trial in an outpatient department for physical medicine and rehabilitation at a university hospital. Based on DSM-5 criteria for sexual dysfunction, 22 patients with sexual dysfunction and stress incontinence were included and randomly allocated to each study arm. The primary outcome measure was the total score on the Female Sexual Function Index. Each group underwent pertinent treatment for 100 min, two times a week for 6 weeks. RESULTS Both groups showed favorable outcomes in increasing Female Sexual Function Index mean scores and their domains. However, for improving sexual function, women in the biofeedback group benefited more than those receiving electrical stimulation. Biofeedback raised desire, arousal, lubrication, orgasm, and satisfaction scores more than electrical stimulation (all p ≤ 0.025). Both interventions decreased pain during or following vaginal penetration similarly (p = 0.985). CONCLUSIONS Both biofeedback and electrical stimulation increased the Female Sexual Function Index score. However, to improve sexual function, women undergoing biofeedback seem to benefit more than those receiving electrical stimulation. We recommend considering the prescription of biofeedback for the treatment of sexual dysfunction because of its efficacy, lack of adverse effects, and easy application.",2020,Both groups showed favorable outcomes in increasing,"['22 patients with sexual dysfunction and stress incontinence', 'outpatient department for physical medicine and rehabilitation at a university hospital', 'sexual dysfunction', 'women with urinary stress incontinence']","['Biofeedback versus electrical stimulation', 'biofeedback and electrical stimulation']","['total score on the Female Sexual Function Index', 'sexual function', 'Female Sexual Function Index score', 'sexual pain dysfunction', 'pain', 'Female Sexual Function Index mean scores', 'Biofeedback raised desire, arousal, lubrication, orgasm, and satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",22.0,0.0595574,Both groups showed favorable outcomes in increasing,"[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Aalaie', 'Affiliation': 'School of Medicine, Department of Physical Medicine and Rehabilitation, Aja University of Medical Sciences, Etemadzadeh St, Western Fatemi, Tehran, Islamic Republic of Iran, Postal code 1411718541.'}, {'ForeName': 'Behroz', 'Initials': 'B', 'LastName': 'Tavana', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Aalaei', 'Affiliation': 'School of Medicine, Department of Psychiatry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Ghaderi', 'Affiliation': 'School of Medicine, Department of Psychiatry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': 'School of Medicine, Department of Physical Medicine and Rehabilitation, Aja University of Medical Sciences, Etemadzadeh St, Western Fatemi, Tehran, Islamic Republic of Iran, Postal code 1411718541. a.dadarkhah@ajaums.ac.ir.'}]",International urogynecology journal,['10.1007/s00192-020-04373-7'] 2694,32529574,"It's not you, it's me - disgust sensitivity towards body odor in deaf and blind individuals.","Disgust might be elicited by various sensory channels, including the sense of smell. It has been previously demonstrated that unpleasant odors emitted by an external source are more disgusting than those emitted by oneself (the source effect). As disgust's main purpose is to help organisms avoid potentially dangerous, contaminating objects, individuals with visual or hearing sensory impairment (thus, with an impeded ability to detect cues indicating pathogen threat) might have developed an increased levels of olfactory disgust sensitivity (modality compensation in disgust sensitivity). We set out to investigate disgust sensitivity in olfaction using the Body Odor Disgust Scale (BODS) on a large sample of 74 deaf and 98 blind participants, with comparison to control groups without sensory impairment (N = 199 in total). The results did not support the hypothesis of modality compensation in disgust sensitivity. Contrary to previous research, neither sex nor age influenced the outcomes. Evidence for the source effect was found. Acquired data are interpreted in the light of social desirability. The emphasis put on the olfaction by blind and deaf individuals is discussed.",2020,The results did not support the hypothesis of modality compensation in disgust sensitivity.,"['large sample of 74 deaf and 98 blind participants, with comparison to control groups without sensory impairment (N = 199 in total']",[],['Body Odor Disgust Scale (BODS'],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0085595', 'cui_str': 'Body odor'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0179141,The results did not support the hypothesis of modality compensation in disgust sensitivity.,"[{'ForeName': 'Michal Mikolaj', 'Initials': 'MM', 'LastName': 'Stefanczyk', 'Affiliation': 'Institute of Psychology, University of Wroclaw, ul. Dawida 1, 50-527, Wroclaw, Poland. michal.m.stefanczyk@gmail.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oleszkiewicz', 'Affiliation': 'Institute of Psychology, University of Wroclaw, ul. Dawida 1, 50-527, Wroclaw, Poland.'}]","Attention, perception & psychophysics",['10.3758/s13414-020-02075-2'] 2695,32529588,Combination effects of diode laser and resin-modified tricalcium silicate on direct pulp capping treatment of caries exposures in permanent teeth: a randomized clinical trial.,"OBJECTIVE The purpose of this randomized clinical trial was to evaluate efficiency of diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA) in direct pulp capping in caries exposures of permanent teeth over a period of 6 months. MATERIAL AND METHODS In this randomized clinical trial, a total of 20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation. At the 1-, 3-, and 6-month recall examinations, the loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes were considered failure. The samples were randomly divided using runs test. Measurements on the digitized radiograph were performed at the recalls. The data were analyzed by repeated measurements ANOVA using SPSS 25. RESULTS Analysis had indicated that at the end of follow-ups, a statistically significant increase in dentin thickness with both groups (p value < 0.001) was found. Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56). In both groups, the highest thickness of dentin formed was at the first month; 0.40 mm ± 0.19 mm (p value < 0.001). CONCLUSION Diode laser 808 nm under proper parameters combined with TheraCal LC can be recommended for direct pulp therapy in caries exposure of permanent teeth. CLINICAL TRIAL REGISTRATION This research was approved by Esfahan Medical University, Dental School, Azad Branch (KHUISF)) Esfahan, Iran [IR.IAU.KHUISF.REC.1397.261].",2020,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","['Esfahan Medical University, Dental School, Azad Branch (KHUISF', 'caries exposures in permanent teeth', '20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with']","['diode laser and resin-modified tricalcium silicate', 'TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation', 'diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA', 'diode laser', 'Diode laser 808 nm under proper parameters combined with TheraCal LC']","['dentin thickness', 'loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes', 'highest thickness of dentin']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0443204', 'cui_str': 'Divergence'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0229986', 'cui_str': 'Application site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1100963', 'cui_str': 'bis(terpyridine)cobalt(II) chloride'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}]",10.0,0.0676895,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","[{'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Yazdanfar', 'Affiliation': 'Laser in Dentistry, RWTH University, Aachen, Germany.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Barekatain', 'Affiliation': 'Department of Restorative and Conservative Dentistry, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran. mehrbarekat@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zare Jahromi', 'Affiliation': 'Department of Endodontic, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}]",Lasers in medical science,['10.1007/s10103-020-03052-9'] 2696,32529596,Nordic Walking and Walking in Parkinson's disease: a randomized single-blind controlled trial.,"INTRODUCTION Non-pharmacological interventions are increasingly being acknowledged as valuable options to overcome or reduce functional problems in patients with Parkinson's disease. In the last decades, Nordic Walking was employed and investigated by rehabilitation specialists. Clinical trials on the effect of Nordic Walking on motor and non-motor Parkinson's disease symptoms are few, small, and heterogeneous for inclusion criteria and intervention protocols. As a result, Nordic Walking training cannot be recommended as a standard rehabilitative tool in Parkinson's disease patients. METHODS This randomized controlled single-blind trial recruited Parkinson's disease patients at a Hoehn and Yahr stage between 2 and 3 assigned to a Nordic Walking vs. Walking group. Subjects were extensively assessed for motor and non-motor symptoms at baseline and after 8 weeks of intervention period. To study the effects of intervention on the overall sample, paired-sample t test and Wilcoxon signed rank test were used, while differences between groups were estimated with general linear models repeated-measure and Mann-Whitney U test. RESULTS Among 32 patients who ended the study period, improvements were observed in the following assessments: global motor outcome (p 0.001), dynamic and static balance ability (p 0.005; p 0.002), global non-motor symptoms outcome (p 0.003), fatigue (p 0.016), anxiety (p 0.043), and quality of life (p 0.003). The treatment group (Nordic Walking) failed to show any difference compared to the control group (Walking) in all considered outcomes. CONCLUSION Nordic Walking was not superior compared to Walking in the studied population. Moderate intensity outdoor group activities like Nordic Walking and Walking seem to improve motor and non-motor symptoms parameters in patients with Parkinson's disease.",2020,"The treatment group (Nordic Walking) failed to show any difference compared to the control group (Walking) in all considered outcomes. ","[""patients with Parkinson's disease"", ""Parkinson's disease"", ""Parkinson's disease patients at a Hoehn and Yahr stage between 2 and 3 assigned to a"", ""Parkinson's disease patients""]","['Nordic Walking and Walking', 'Nordic Walking vs. Walking group', 'Moderate intensity outdoor group activities like Nordic Walking and Walking', 'Nordic Walking', 'Nordic Walking training']","['quality of life', 'anxiety', 'fatigue', 'global motor outcome', 'global non-motor symptoms outcome', 'dynamic and static balance ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}]",32.0,0.0243724,"The treatment group (Nordic Walking) failed to show any difference compared to the control group (Walking) in all considered outcomes. ","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Granziera', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, ""Villa Salus"" Hospital, Mestre (VE), Italy. serena.granziera@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alessandri', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, ""Villa Salus"" Hospital, Mestre (VE), Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lazzaro', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, ""Villa Salus"" Hospital, Mestre (VE), Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Zara', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, ""Villa Salus"" Hospital, Mestre (VE), Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Scarpa', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, ""Villa Salus"" Hospital, Mestre (VE), Italy.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01617-w'] 2697,32529903,Does longitudinal or transverse orientation of the ultrasound probe improve cannulation success in minimally invasive venous surgery: A multicentre randomised controlled trial.,"OBJECTIVE This study evaluates the effect of transverse and longitudinal ultrasound transducer orientation on saphenous vein cannulation during endovenous ablation. METHODS A single-blinded, multicentre, randomised controlled trial was performed in patients undergoing ultrasound-guided venous cannulation for saphenous ablation. The primary outcomes were overall cannulation success and time to successful cannulation. RESULTS In total, 100 patients were assigned to parallel longitudinal orientation and transverse orientation groups. Cannulation success was 100%. There was no significant variation in time to cannulation detected between the transverse orientation and longitudinal orientation (85 s vs. 71 s, p  = 0.314). Longitudinal orientation was associated with significantly fewer needle passes [median 3 (interquartile range 1-5) vs. 2 (interquartile range 1-3), p  = 0.026] and less pain (median visual analogue scale score 1 vs. 2.5, p  = 0.039) than those in the transverse orientation group. CONCLUSION This trial has shown that while longitudinal orientation is associated with less procedural pain it has no significant effect on time to target vein cannulation during endovenous ablation.",2020,"Longitudinal orientation was associated with significantly fewer needle passes [median 3 (interquartile range 1-5) vs. 2 (interquartile range 1-3), p  = 0.026] and less pain (median visual analogue scale score 1 vs. 2.5, p  = 0.039) than those in the transverse orientation group. ","['100 patients', 'patients undergoing', 'minimally invasive venous surgery']","['ultrasound probe', 'ultrasound-guided venous cannulation for saphenous ablation', 'transverse and longitudinal ultrasound transducer orientation']","['pain (median visual analogue scale score', 'time to cannulation', 'Cannulation success', 'overall cannulation success and time to successful cannulation', 'cannulation success', 'needle passes']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",100.0,0.236766,"Longitudinal orientation was associated with significantly fewer needle passes [median 3 (interquartile range 1-5) vs. 2 (interquartile range 1-3), p  = 0.026] and less pain (median visual analogue scale score 1 vs. 2.5, p  = 0.039) than those in the transverse orientation group. ","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Aherne', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}, {'ForeName': 'Adeel S', 'Initials': 'AS', 'LastName': 'Zafar', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gourlay', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}, {'ForeName': 'Damien C', 'Initials': 'DC', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Interventional Radiology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Bashar', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}, {'ForeName': 'Charyl Jq', 'Initials': 'CJ', 'LastName': 'Yap', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}, {'ForeName': 'Tjun Y', 'Initials': 'TY', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, Singapore General Hospital, Singapore.'}, {'ForeName': 'Stewart R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Department of Vascular Surgery, University Hospital Galway, Ireland.'}]",Phlebology,['10.1177/0268355520932401'] 2698,32529929,Storytelling of suicide attempt recovery and its relationship with mental health treatment-seeking attitudes and behaviors: An experimental study.,Objective: This experimental study investigated if watching a brief video detailing an individual's recovery following a suicide attempt increased college student mental health treatment-seeking attitudes and resource engagement more than viewing a psychoeducational video about suicide. Participants: Undergraduate student participants (N = 218) completed the study online. Methods: Participants were randomized to see either the storytelling or one of two narrated psychoeducation videos and complete self-report measures following video viewing. Results: Video condition as well as its interaction with levels of identification with the storyteller/video narrator generally did not predict treatment-seeking attitudes as hypothesized. A small but not statistically significant effect for immediate resource engagement was seen as those in the storytelling condition interacted with online suicide prevention more than those in one of the psychoeducation conditions. Conclusions: These results suggest that brief viewing of storytelling about lived experience with suicide may have minimal impact on treatment-seeking propensity in college students.,2020,A small but not statistically significant effect for immediate resource engagement was seen as those in the storytelling condition interacted with online suicide prevention more than those in one of the psychoeducation conditions. ,"['college students', 'Participants: Undergraduate student participants (N\u2009=\u2009218) completed the study online']","['mental health treatment-seeking attitudes and behaviors', 'storytelling or one of two narrated psychoeducation videos and complete self-report measures following video viewing']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",[],,0.0326292,A small but not statistically significant effect for immediate resource engagement was seen as those in the storytelling condition interacted with online suicide prevention more than those in one of the psychoeducation conditions. ,"[{'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Tucker', 'Affiliation': 'Department of Psychology, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Haydel', 'Affiliation': 'Department of Psychology, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zielinski', 'Affiliation': 'Department of Psychiatry, Louisiana State University Health Sciences Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Niederkrotenthaler', 'Affiliation': 'Medical University of Vienna, Center for Public Health, Department of Social and Preventive Medicine, Unit Suicide Research & Mental Health Promotion, Vienna, Austria.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1767110'] 2699,32529933,Utilizing ACT daily as a self-guided app for clients waiting for services at a college counseling center: A pilot study.,"Objective : Considering increasing demands for mental health services at college counseling centers (CCCs), there is a need for cost-effective solutions that avoid depleting stressed CCC resources. This study examined if ACT Daily, a mobile application based on acceptance and commitment therapy (ACT), could serve as an effective self-guided intervention. Participants : 11 individuals on a CCC waitlist suffering from anxiety/depression participated in the study over 2 weeks. Methods : This study implemented a pre-post, open trial design of ACT Daily. Assessments were completed at baseline and 2-week post assessment. Results : Results indicated that ACT Daily was acceptable and that participants improved on depression and anxiety symptoms as well as psychological inflexibility processes over the 2 weeks. App data further indicated significant in-the-moment improvements on depression, anxiety and psychological inflexibility immediately following skill coaching, with these effects becoming larger over time. Conclusions : Mobile apps like ACT Daily could serve as an effective, pre-therapy tool for depressed/anxious students.",2020,Results indicated that ACT Daily was acceptable and that participants improved on depression and anxiety symptoms as well as psychological inflexibility processes over the 2 weeks.,"['Participants : 11 individuals on a CCC waitlist suffering from anxiety/depression participated in the study over 2\u2009weeks', 'clients waiting for services at a college counseling center', 'mental health services at college counseling centers (CCCs', 'depressed/anxious students']","['mobile application based on acceptance and commitment therapy (ACT', 'ACT']","['depression and anxiety symptoms', 'psychological inflexibility processes', 'depression, anxiety and psychological inflexibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0464237,Results indicated that ACT Daily was acceptable and that participants improved on depression and anxiety symptoms as well as psychological inflexibility processes over the 2 weeks.,"[{'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Haeger', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Carter H', 'Initials': 'CH', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1763366'] 2700,32529940,Effectiveness of transparent film dressing for peripheral intravenous catheter.,"BACKGROUND The intravenous applications are the most common type of such interventions. It is underlined that in cases where the peripheral intravenous catheter is not properly secured in place, even a minor movement inside the vein would result in injury of vein. OBJECTIVE The insertion of peripheral intravenous catheter is a common practice. This is a randomized controlled prospective study aiming at investigating the effectiveness of use of transparent film dressing for peripheral intravenous catheter. METHODS The universe of this study included inpatients in the Internal Diseases clinic of a University Hospital, and the sample included a total of 110 peripheral intravenous catheters that were calculated by power analysis. The patient identification form, the peripheral venous catheter and treatment information form, and the visual infusion phlebitis identification scale were used to collect data. The forms were completed by the investigators on the basis of daily observations. The data were assessed by the percentage, chi-square test, and logistic regression analysis via the software SPSS 20.00. RESULTS The individuals in the study group and the control group included in the sample are comparable in terms of gender, having/not having a chronic disease, the site of peripheral intravenous catheter, use of antibiotics, intravenous fluid therapy, and mean age. There were no statistically significant differences between the groups. There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. CONCLUSION The use of transparent film dressing for insertion of peripheral intravenous catheter can be recommended as it increases the dwell time for the catheter and reduces incidence of complications.",2020,"There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. ","['individuals in the study group and the control group included in the sample are comparable in terms of gender, having/not having a chronic disease, the site of peripheral intravenous catheter, use of antibiotics, intravenous fluid therapy, and mean age', 'peripheral intravenous catheter', 'inpatients in the Internal Diseases clinic of a University Hospital, and the sample included a total of 110 peripheral intravenous catheters that were calculated by power analysis']",['transparent film dressing'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0770788', 'cui_str': 'Transparent dressing'}]",[],110.0,0.0473162,"There was a significant relationship between the dwell time for the catheter and development of any complications and the groups. ","[{'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Atay', 'Affiliation': 'Nursing Department at Faculty of Health Science, Çanakkale Onsekiz Mart University, Canakkale, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Yilmaz Kurt', 'Affiliation': 'Nursing Department at Faculty of Health Science, Çanakkale Onsekiz Mart University, Canakkale, Turkey.'}]",The journal of vascular access,['10.1177/1129729820927238'] 2701,32530041,"Effect of performance-based financing on health service delivery: a case study from Adamawa state, Nigeria.","The Nigeria State Health Investment Project (NSHIP) was implemented in three Nigerian states between 2013 and 2018. Under the NSHIP, some local government areas were randomly assigned to Performance-Based Financing (PBF) intervention while others received decentralized facility financing (DFF) for comparison. This article evaluates the effect of PBF compared with DFF on health service delivery indicators in Adamawa state, under this quasi-experimental design, using the difference-in-differences technique. The analysis used health facility monthly data collected by the Health Management Information System through the District Health Information Software 2 (DHIS2). The PBF intervention group significantly increased the quantity of most of its service delivery indicators, such as antenatal care visits and deliveries by skilled personnel compared with the comparison group (DFF) after the introduction of NSHIP, although the baseline level of service delivery between PBF and DFF health facilities was statistically identical prior to the introduction of the intervention. We also conducted robustness check analysis to confirm the effect of PBF. Overall, we found a significant positive effect of PBF on most service delivery outcomes, except full vaccinations and post-natal care. One important policy implication is that we should carefully use PBF for targeted indicators.",2020,"The PBF intervention group significantly increased the quantity of most of its service delivery indicators, such as antenatal care visits and deliveries by skilled personnel compared with the comparison group (DFF) after the introduction of NSHIP, although the baseline level of service delivery between PBF and DFF health facilities was statistically identical prior to the introduction of the intervention.",[],"['PBF intervention', 'DFF', 'PBF', 'performance-based financing', 'Performance-Based Financing (PBF) intervention while others received decentralized facility financing (DFF']","['quantity of most of its service delivery indicators, such as antenatal care visits and deliveries by skilled personnel']",[],"[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",,0.0253758,"The PBF intervention group significantly increased the quantity of most of its service delivery indicators, such as antenatal care visits and deliveries by skilled personnel compared with the comparison group (DFF) after the introduction of NSHIP, although the baseline level of service delivery between PBF and DFF health facilities was statistically identical prior to the introduction of the intervention.","[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 90 Smith Street, Boston, MA, 02120 USA.'}, {'ForeName': 'Abdullahi', 'Initials': 'A', 'LastName': 'Belel', 'Affiliation': 'Yola, Adamawa State, Nigeria.'}]",International health,['10.1093/inthealth/ihaa026'] 2702,32530334,Autologous plasma gel injection combined with scar subcision is a successful technique for atrophic post-acne scars: A split-face study.,"Background: Different therapeutic options can be used for post-acne scarring. Scar subcision alone or in combination with other treatments have been used by many dermatologists to treat post-acne scarring. Objectives: We thought to study and compare the efficacy and safety of scar subcision combined with platelet gel injection versus scar subcision combined with PRP injection for atrophic post-acne scarring. Patients and methods: Scar subcision was done 1 st on both sides of the face. Plasma gel injection was done on the right side and PRP injection was done on the left side. The sessions were done monthly for 4 months followed by a 6-month follow-up period. Evaluation of the results and any complications were recorded. Results: There was a significant improvement (p = 0.035) of the scars on the subcision-gel-side at one month following the 1 st treatment session. However, along with the following sessions there were no significant differences between both sides. Finally, at the follow-up visit after 6 months following the end of the treatment course there was a significant difference between the 2 sides of the face in favor of the subcision-gel-side. Conclusions: Subcision combined with autologous plasma gel injection is a successful technique for atrophic post-acne scars.",2020,There was a significant improvement (p = 0.035) of the scars on the subcision-gel-side at one month following the 1 st treatment session.,"['atrophic post-acne scars', 'atrophic post-acne scarring']","['Autologous plasma gel injection combined with scar subcision', 'Subcision combined with autologous plasma gel injection', 'scar subcision combined with platelet gel injection versus scar subcision combined with PRP injection']","['efficacy and safety', 'Scar subcision']","[{'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C4761112', 'cui_str': 'Subcision'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C4761112', 'cui_str': 'Subcision'}]",,0.0216317,There was a significant improvement (p = 0.035) of the scars on the subcision-gel-side at one month following the 1 st treatment session.,"[{'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Nassar', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'El-Shaarawy', 'Affiliation': 'Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Salah', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Zagazig University, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782322'] 2703,32530335,The effect of new cross linked hyaluronan gel on quality of life of patients after deep infiltrating endometriosis surgery: a randomized controlled pilot study.,"In this prospective randomised placebo-controlled study, we aimed to evaluate the effect of New Cross linked Hyaluronan Gel (NCH gel) on the quality of life of patients who underwent laparoscopic surgery due to Deep Infiltrating Endometriosis (DIE). The intervention group received 40 mL of NCH gel, and the control group had a 40 mL sterile saline solution instilled into the peritoneal cavity following standard laparoscopic procedures. The patients were called in the third and sixth postoperative months and requested to fill the Visual Analogue Scale (VAS), Endometriosis Health Profile (EHP-5), and Short Form for Mental and Physical Health (SF-12) questionnaires. There was a significant reduction in dysmenorrhoea, dyschezia, dyspareunia VAS scores at 3rd, and 6th-month visits in NCH gel group. The postoperative 6th-month EHP-5 scores were significantly lower (1.16 ± 1.51, p -value: .02) in NCH gel group. Besides, NCH gel group had higher SF-12 mental and SF-12 physical scores. Clinical Trials registration number: NCT04023383IMPACT STATEMENT What is already known on this subject? Application of solid or liquid physical barriers is believed to be a promising strategy to reduce adhesions after laparoscopic endometriosis surgery. However, comparable data regarding the effects of adhesion barriers are still lacking. What the results of this study add? We revealed that there was a significantly higher decrease in VAS and EHP-5 scores and an increase in SF-12 physical-mental ratings after surgery in NCH gel group. What are the implications of these findings for clinical practice and/or further research? Using NHC gel in addition to standard surgical procedure improves postoperative VAS scores, and provides better quality of life scores.",2020,"There was a significant reduction in dysmenorrhoea, dyschezia, dyspareunia VAS scores at 3rd, and 6th-month visits in NCH gel group.","['patients after deep infiltrating endometriosis surgery', 'patients who underwent laparoscopic surgery due to Deep Infiltrating Endometriosis (DIE']","['NHC gel', 'NCT04023383IMPACT', 'New Cross linked Hyaluronan Gel (NCH gel', 'NCH gel', 'new cross linked hyaluronan gel', '40\u2009mL of NCH gel, and the control group had a 40\u2009mL sterile saline solution instilled into the peritoneal cavity following standard laparoscopic procedures', 'placebo']","['quality of life', 'SF-12 physical-mental ratings', 'dysmenorrhoea, dyschezia, dyspareunia VAS scores', 'VAS and EHP-5 scores', 'postoperative 6th-month EHP-5 scores', 'postoperative VAS scores', 'Visual Analogue Scale (VAS), Endometriosis Health Profile (EHP-5), and Short Form for Mental and Physical Health (SF-12) questionnaires', 'quality of life scores', 'SF-12 mental and SF-12 physical scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0268059', 'cui_str': 'Neonatal hemochromatosis'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1720298', 'cui_str': 'Instill'}, {'cui': 'C1704247', 'cui_str': 'Peritoneal cavity structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0237326', 'cui_str': 'Pain associated with defecation'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0747727,"There was a significant reduction in dysmenorrhoea, dyschezia, dyspareunia VAS scores at 3rd, and 6th-month visits in NCH gel group.","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ekin', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Kaya', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Şakir Volkan', 'Initials': 'ŞV', 'LastName': 'Erdoğan', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Bahçeci', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Baghaki', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Yaşar', 'Affiliation': 'Department of Obstetric and Gynaecology, University of Health Sciences Turkey, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1755628'] 2704,32530339,"The effect of multistrain synbiotic and vitamin D3 supplements on the severity of atopic dermatitis among infants under 1 year of age; a double-blind, randomized clinical trial study.","Background: Atopic dermatitis (AD) is the most common chronic and recurrent skin disease during infancy. Objective: This study was aimed at evaluating the effect of synbiotic and vitamin D3 supplements on the severity of AD among infants under 1 year of age. Methods: This double-blind, randomized clinical trial study was conducted on 81 subjects with AD in Sabzevar, Iran in 2018. Subjects were randomly assigned to three groups. Synbiotic group was administered a dose of 5 drops/day of synbiotic in addition to routine treatment. Vitamin D3 group was administered 1000 units (IU) of vitamin D3 daily in addition to routine treatment. Control group just received routine treatments. The severity of AD was evaluated using SCORing Atopic Dermatitis (SCORAD) at baseline and two months' follow-up. Results: The mean age of subjects was 4.87 ± 3.5 and 59.26% (n = 48) were male. The mean SCOARD scores was substantially decreased in the synbiotic (b xy : -13.90, 95% CI, -20.99, -6.81; P  < 0.001) and vitamin D3 (b xy : -12.38, 95% CI, -19.33, -5.43; P  = 0.001) groups as compared to control one by the end of two months. Conclusion: Findings suggest that multistrain synbiotic and vitamin D3 supplements administration along with routine treatments, as complementary therapies, may be effective in reducing the severity of AD in infants.",2020,"The mean SCOARD scores was substantially decreased in the synbiotic (b xy : -13.90, 95% CI, -20.99, -6.81; P  < 0.001) and vitamin D3 (b xy :","['81 subjects with AD in Sabzevar, Iran in 2018', 'infants under 1 year of age', 'The mean age of subjects was 4.87\u2009±\u20093.5 and 59.26% (n\u2009=\u200948) were male']","['synbiotic and vitamin D3 supplements', 'multistrain synbiotic and vitamin D3 supplements', 'Vitamin D3', 'Synbiotic', 'vitamin D3']","['vitamin D3', 'severity of atopic dermatitis', 'mean SCOARD scores', 'SCORing Atopic Dermatitis (SCORAD']","[{'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",81.0,0.310092,"The mean SCOARD scores was substantially decreased in the synbiotic (b xy : -13.90, 95% CI, -20.99, -6.81; P  < 0.001) and vitamin D3 (b xy :","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Aldaghi', 'Affiliation': 'Department of Paediatric, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Human', 'Initials': 'H', 'LastName': 'Tehrani', 'Affiliation': 'Department of Paediatric, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': 'Department of Dermatology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sham Abadi', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782319'] 2705,32530340,Perineal skin tear repair following vaginal birth; skin adhesive versus conventional suture - a randomised controlled trial.,"This was a prospective randomised controlled trial comparing the effects of first-degree perineal tear repair using adhesive glue versus conventional suturing in terms of pain score, wound complication and patient's satisfaction. One hundred and twenty one women were randomised. The skin adhesive group had a significantly lower pain score at rest as well as during sitting, walking and micturition during the first week of delivery compared to the suture group. The time taken to become pain free was significantly shorter in the tissue adhesive group (3.18 vs. 8.65 days, p < .001). Only two patients who had skin glue experienced wound gaping. No significant difference was observed in the level of satisfaction between the adhesive and suture groups. Tissue adhesive is better than subcuticular suture for repairing first-degree perineal tear as it causes less pain and has shorter recovery time.Impact statement What is already known on this subject . First- and second-degree tears following vaginal delivery are common and involved a third of women. Suturing of these tears is advocated to avoid wound gaping and poor healing. What the results of this study add. For first-degree tear repair, tissue adhesive is better than conventional suture in terms of pain reduction and recovery time. What the implications are of these findings for clinical practice and/or further research . Skin adhesive is an ideal method for first-degree perineal tear repair especially in out of hospital settings such as home birth or midwifery-led centre. A larger scale study is needed to establish its feasibility for second- and third-degree tears repair.",2020,"The skin adhesive group had a significantly lower pain score at rest as well as during sitting, walking and micturition during the first week of delivery compared to the suture group.",['One hundred and twenty one women were randomised'],"['Perineal skin tear repair following vaginal birth; skin adhesive versus conventional suture ', 'subcuticular suture', 'first-degree perineal tear repair using adhesive glue versus conventional suturing']","['pain reduction and recovery time', 'time taken to become pain free', 'skin glue experienced wound gaping', 'level of satisfaction', 'pain score', ""pain score, wound complication and patient's satisfaction""]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0877377', 'cui_str': 'Tear of skin'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0404427', 'cui_str': 'Repair of perineal tear'}, {'cui': 'C0017780', 'cui_str': 'Glue'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",121.0,0.0447252,"The skin adhesive group had a significantly lower pain score at rest as well as during sitting, walking and micturition during the first week of delivery compared to the suture group.","[{'ForeName': 'Rima Anggrena', 'Initials': 'RA', 'LastName': 'Dasrilsyah', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Kalok', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Beng Kwang', 'Initials': 'BK', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Anizah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kah', 'Initials': 'K', 'LastName': 'Teik Chew', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pei Shan', 'Initials': 'PS', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1740917'] 2706,32530368,Mnemonic discrimination and social anxiety: the role of state anxiety.,"The Mnemonic Similarity Task (MST) measures mnemonic discrimination, or the ability to correctly identify new stimuli from highly similar, old stimuli. Poor mnemonic discrimination is a potential risk or maintenance factor for anxiety, and recent studies suggest state affect may moderate relations between mnemonic discrimination and trait anxiety. No studies have evaluated mnemonic discrimination in specific subtypes of anxiety or with clinically relevant stressors. This preregistered study evaluated the role of social anxiety and the anticipation of a future speech on MST performance. Participants with high ( n  = 66) and low ( n  = 64) levels of social anxiety were randomly assigned to a stressor condition or a control condition prior to the MST. State anxiety was measured throughout the study. Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination. Results are compared with previous research and implications and future directions are discussed.",2020,Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination.,['Participants with high ( n \u2009=\u200966) and low ( n \u2009=\u200964) levels of social anxiety'],['stressor condition or a control condition prior to the MST'],"['State anxiety', 'Mnemonic discrimination and social anxiety']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]",,0.0105994,Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination.,"[{'ForeName': 'Gabriella T', 'Initials': 'GT', 'LastName': 'Ponzini', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, USA.'}, {'ForeName': 'Shari A', 'Initials': 'SA', 'LastName': 'Steinman', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, USA.'}]",Cognition & emotion,['10.1080/02699931.2020.1779039'] 2707,32530373,Comparing the effect of acupressure with or without ice in LI-4 point on labour pain and anxiety levels during labour: a randomised controlled trial.,"The aim of this study was to assess the effect of acupressure with or without ice on reducing pain and anxiety during labour. The anxiety level of mothers was measured before and after study using Spielberger Inventory along with the labour pain. To improve the strength of this study, a meta-analysis was conducted on the effect of acupressure in point LI-4 on anxiety during labour. Ninety women in labour were randomly divided into three groups: acupressure with ice, acupressure without ice and the control group. The result suggested that women receiving both acupressure with ice ( p  = .005) or without ice ( p  < .001) experienced less labour pain in comparison with the control group. Also, the labour pain severity in acupressure without ice was lower than the group with ice ( p  < .001). Acupressure with ( p  = 1) or without ( p  = .09) ice was not significantly different from the control group in terms of the anxiety level. However, women in the group of acupressure without ice experienced less anxiety in comparison with acupressure with ice ( p  = .04). The difference in pain severity before and after treatment with acupressure with (RCI = 2.86) or without ice (RCI = 5.54) was clinically significant. The intervention was not clinically meaningful in terms of anxiety.Impact statement What is already known on this subject? Previous trials have exhibited that acupressure with/without ice reduced pain and anxiety during labour. What do the results of this subject add? The results of this research was consistent with previous studies, suggesting that acupressure, with or without ice, is more effective than the control group regarding labour pain. However, the group of acupressure with ice was not different from the control group with respect to the anxiety level. What are the implications of these findings for clinical practice and/or further research? In light of advantages, such as growing preference of women, researcher and health care providers for physiological delivery coupled with its safety and simplicity, it can be used as an effective technique to manage labour pain. Further studies are required to assess the effect of acupressure at L4 on the anxiety level.",2020,"However, the group of acupressure with ice was not different from the control group with respect to the anxiety level.","['labour', 'Ninety women in labour']","['acupressure with or without ice', 'Acupressure with ( p \u2009=\u20091) or without ', 'acupressure with ice, acupressure without ice and the control group', 'acupressure', 'acupressure with or without ice in LI-4 point']","['labour pain severity', 'anxiety', 'pain severity', 'labour pain and anxiety levels', 'anxiety level', 'pain and anxiety', 'labour pain', 'anxiety level of mothers']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",90.0,0.0444285,"However, the group of acupressure with ice was not different from the control group with respect to the anxiety level.","[{'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Mirzaee', 'Affiliation': 'Kerman Nursing Research Center, Razi School of Nursing and Midwifery Faculty, Kerman University of Medical Science, Kerman, Iran.'}, {'ForeName': 'Fatemeh Esmaeilinejad', 'Initials': 'FE', 'LastName': 'Hasaroeih', 'Affiliation': 'Students Research Committee, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Ghazanfarpour', 'Affiliation': 'Kerman Nursing Research Center, Razi School of Nursing and Midwifery Faculty, Kerman University of Medical Science, Kerman, Iran.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1747412'] 2708,32524985,Results of Surgical Coronary Revascularization Alone Versus Combined Surgical Revascularization and Mitral Valve Repair in Patients With Moderate Ischemic Mitral Regurgitation.,"BACKGROUND This is a prospective randomized-controlled study aiming to determine whether the optimal surgical management of moderate ischemic mitral regurgitation is to revascularize the heart through performing coronary artery bypass grafting alone or together with repairing the mitral valve. METHODS Between April 2014 and November 2014, 40 patients with ischemic heart disease associated with moderate ischemic mitral regurgitation at our University hospitals were divided into 2 matched groups. Group 1 received both coronary artery bypass grafting surgery together with mitral valve repair, while Group 2 underwent coronary artery bypass grafting surgery alone. RESULTS No statistically significant difference was found between both study groups, in terms of operative data, except for cardiopulmonary bypass time and aortic cross-clamp time, which were significantly longer in Group 1 (P < .001). Only one case died in the study in Group 1 on the third postoperative day, due to severe low cardiac output syndrome. During the follow up, NYHA class improved in Group 1 from 2.6 to 1.35 (P < .004), but in Group 2 NYHA class improved from 2.55 to 1.72 (P = .07). The degree of MR improved in 19 patients (95%) in Group 1 compared with 15 (75%) patients in Group 2 (P < .0001). CONCLUSION Our study showed meaningful advantages of adding mitral-valve repair to CABG in patients with ischemic heart disease and moderate ischemic mitral regurgitation, regarding the degree of MR and functional NYHA class. On the other hand, there was no statistically significant difference between both groups in postoperative coarse and in-hospital mortality.",2020,"The degree of MR improved in 19 patients (95%) in Group 1 compared with 15 (75%) patients in Group 2 (P < .0001). ","['patients with ischemic heart disease and moderate ischemic mitral regurgitation', 'Between April 2014 and November 2014', '40 patients with ischemic heart disease associated with moderate ischemic mitral regurgitation at our University hospitals', 'Patients With Moderate Ischemic Mitral Regurgitation']","['coronary artery bypass grafting alone', 'mitral-valve repair to CABG', 'coronary artery bypass grafting surgery together with mitral valve repair, while Group 2 underwent coronary artery bypass grafting surgery alone', 'Surgical Coronary Revascularization Alone Versus Combined Surgical Revascularization and Mitral Valve Repair']","['degree of MR', 'postoperative coarse and in-hospital mortality', 'operative data, except for cardiopulmonary bypass time and aortic cross-clamp time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",40.0,0.013605,"The degree of MR improved in 19 patients (95%) in Group 1 compared with 15 (75%) patients in Group 2 (P < .0001). ","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khallaf', 'Affiliation': 'Department of Cardiothoracic Surgery, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Elzayadi', 'Affiliation': 'Department of Cardiothoracic Surgery, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Alkady', 'Affiliation': 'Department of Cardiothoracic Surgery, Cairo University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El Naggar', 'Affiliation': 'Department of Cardiothoracic Surgery, Cairo University, Egypt.'}]",The heart surgery forum,['10.1532/hsf.2773'] 2709,32524991,Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials.,"BACKGROUND Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously. OBJECTIVE To determine omalizumab safety/efficacy in CRSwNP in phase 3 trials (POLYP 1, POLYP 2). METHODS Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS). Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), sense of smell, postnasal drip, runny nose, and adverse events (AEs). RESULTS Patients in POLYP 1 (n=138) and POLYP 2 (n=127) exhibited severe CRSwNP and substantial quality-of-life impairment evidenced by mean NPS >6 and SNOT-22 of ∼60. Both studies met both coprimary end points. SNOT-22, UPSIT, sense of smell, postnasal drip and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, mean changes from baseline at week 24 for omalizumab versus placebo were: NPS, -1.08 versus 0.06 (P<.0001) and -0.90 versus -0.31 (P=.0140); NCS, -0.89 versus -0.35 (P=.0004) and -0.70 versus -0.20 (P=.0017); SNOT-22, -24.7 versus -8.6 (P<.0001) and -21.6 versus -6.6 (P<.0001). AEs were similar between groups. CONCLUSION Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and was well tolerated.",2020,"The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously. ","['nasal polyposis', 'Adults with CRSwNP with inadequate response to intranasal corticosteroids', 'Chronic rhinosinusitis with nasal polyps (CRSwNP', 'patients with CRSwNP and comorbid asthma previously', 'Patients in POLYP 1']","['omalizumab or placebo and intranasal mometasone', 'CRSwNP', 'Omalizumab', 'omalizumab', 'placebo']","['change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), sense of smell, postnasal drip, runny nose, and adverse events (AEs', 'tolerated', 'Efficacy and safety', 'SNOT-22, UPSIT, sense of smell, postnasal drip and runny nose', 'Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS', 'severe CRSwNP and substantial quality-of-life impairment']","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.169777,"The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously. ","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Omachi', 'Affiliation': 'Genentech, Inc., South San Francisco, CA. Electronic address: omachi.theodore@gene.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Mullol', 'Affiliation': 'Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Stella E', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh, PA.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ligueros-Saylan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Monet', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Lutaf', 'Initials': 'L', 'LastName': 'Islam', 'Affiliation': 'Roche, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium; Division of ENT Diseases, CLINTEC, Karolinska Institute, Stockholm, Sweden.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.032'] 2710,32525036,"One layer or two: does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088'] 2711,32525048,"Effects on Ocular Biometrics by 0.05%, 0.025%, and 0.01% Atropine: Low-concentration Atropine for Myopia Progression (LAMP) Study.","BACKGROUND Anti-myopia effect of 0.01% atropine over placebo affected spherical equivalent (SE) but not axial length (AL) elongation in both ATOM2 study and LAMP study. It is possible that atropine might exert its effect through changes in corneal properties or lens power. PURPOSE To evaluate changes of ocular biometrics in the 0.05%, 0.025%, and 0.01% atropine groups compared to placebo over one year based on the LAMP study. DESIGN Double-blinded, randomized, placebo-controlled trial. PARTICIPANTS 383 children aged 4 to 12 years, who were randomly assigned to receive 0.05%, 0.025%, 0.01% atropine, or placebo once daily in both eyes and completed the first year of the LAMP study. METHODS Cycloplegic SE, AL, corneal curvatures, and anterior chamber depth (ACD), were measured by IOL Master. Corneal astigmatism and lens power were calculated. The ocular biometric parameters changes were compared among various groups. Contributions to SE progression from ocular parameters were determined and compared among various groups. MAIN OUTCOME MEASURES Changes in ocular biometrics and their associations with the changes in SE. RESULTS Over one year, changes in AL were 0.20±0.25mm, 0.29±0.20mm, 0.36±0.29mm, and 0.41±0.22mm in 0.05%, 0.025%, 0.01% atropine and placebo, respectively (p<0.001), with a concentration-dependent response. Corneal power remained stable, and its changes were similar across all atropine concentrations, with -0.02±0.14D, -0.01±0.14D, -0.01±0.12D, and 0.01±0.14D in 0.05%, 0.025%, and 0.01% atropine, and placebo, respectively (p = 0.10). Lens power decreased over time in each concentration, but its changes were also similar across all concentrations, with -0.31±0.43D, -0.38±0.47D, -0.40±0.43D, and -0.41±0.43D in 0.05%, 0.025%, 0.01% atropine and placebo respectively (p=0.24). ACD deepened over time, but its changes remained similar across all concentrations (p=0.41). The contributions to SE progression from the ocular biometric changes including changes of K, AL, and lens power after adjusting for age and gender, in each concentration were similar (p>0.05). CONCLUSIONS Low-concentrations of atropine 0.05%, 0.025%, and 0.01% have no clinical effect on corneal power and lens power. The anti-myopic effects of low-concentration atropine act mainly on reducing AL elongation, and therefore could reduce risk of subsequent myopia complications.",2020,"BACKGROUND Anti-myopia effect of 0.01% atropine over placebo affected spherical equivalent (SE) but not axial length (AL) elongation in both ATOM2 study and LAMP study.",['383 children aged 4 to 12 years'],"['atropine, or placebo', 'Atropine: Low-concentration Atropine', 'low-concentration atropine', 'atropine', 'placebo']","['Ocular Biometrics', 'changes of K, AL, and lens power', 'ocular biometric parameters changes', 'ocular biometrics', 'Corneal astigmatism and lens power', 'ocular biometrics and their associations with the changes in SE', 'AL, corneal curvatures, and anterior chamber depth (ACD', 'corneal power and lens power', 'Corneal power']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}]",383.0,0.359246,"BACKGROUND Anti-myopia effect of 0.01% atropine over placebo affected spherical equivalent (SE) but not axial length (AL) elongation in both ATOM2 study and LAMP study.","[{'ForeName': 'Fen-Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Yuzhou', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Li-Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chi-Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong SAR, China; Hong Kong Eye Hospital, Hong Kong SAR, China. Electronic address: yamcheuksing@cuhk.edu.hk.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.004'] 2712,32525222,Effects of Bilateral Transcranial Direct Current Stimulation on Working Memory and Global Cognition in Older Patients with Remitted Major Depression: A Pilot Randomized Clinical Trial.,"OBJECTIVES To assess the effects of a 10-day course of bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on working memory and global cognition in elderly participants with remitted major depressive disorder at 14 days (primary outcome) and 90 days (secondary outcome) post intervention. DESIGN Randomized double blind controlled trial (clinicaltrials.gov # NCT02212366). SETTING Community dwelling outpatient setting. PARTICIPANTS 60 or older with previous single or recurrent episodes of major depression currently in full remission. INTERVENTION A 10 day course of active or sham bilateral DLPFC anodal tDCS. MEASUREMENTS 1) working memory assessed by a computerized N back task, and 2) global cognition assessed by a standard paper and pencil neuropsychological test battery.. RESULTS Thirty-three participants, (mean (SD) age = 66. 5 (5.7) year) were enrolled, out of which 18 (mean (SD) age = 66. 3 (5.8) year) were randomized to active tDCS and 15 (mean (SD) age = 66. 7 (5.8) years) to sham tDCS. All randomized participants except one from the sham group -completed the tDCS course. There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention. Both groups showed promising changes in working memory and global cognition over time. CONCLUSIONS tDCS was well tolerated in older patients with remitted MDD, however, as compared to the sham group, it did not improve working memory or global cognition. Future studies should investigate tDCS with alternative parameters to enhance cognition in this population. This article is protected by copyright. All rights reserved.",2020,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"['elderly participants with remitted major depressive disorder at 14\u2009days (primary outcome) and 90\u2009days (secondary outcome) post intervention', 'Thirty-three participants, (mean (SD) age\xa0', 'Community dwelling outpatient setting', 'older patients with remitted MDD', '60 or older with previous single or recurrent episodes of major depression currently in full remission', 'Older Patients with Remitted Major Depression', '5 (5.7) year) were enrolled, out of which 18 (mean (SD) age\xa0=\xa066']","['Bilateral Transcranial Direct Current Stimulation', 'active or sham bilateral DLPFC anodal tDCS', 'tDCS', 'bilateral anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC', 'active tDCS']","['working memory performance or global cognition', 'working memory or global cognition', '1) working memory assessed by a computerized N back task, and 2) global cognition assessed by a standard paper and pencil neuropsychological test battery', 'Working Memory and Global Cognition', 'working memory and global cognition']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.222182,There were no differences between the groups on working memory performance or global cognition at 14 or 90 days post intervention.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Judah', 'Initials': 'J', 'LastName': 'Batist', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ghazala', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Reza M', 'Initials': 'RM', 'LastName': 'Zomorrodi', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brooks', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Geriatric Psychiatry Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5361'] 2713,32525235,Continuation Sessions of Mindfulness-Based Cognitive Therapy (MBCT-C) vs Treatment as Usual in Late-Life Depression and Anxiety: An Open-Label Extension Study: Mindfulness Continuation Sessions for Older Adults.,"OBJECTIVES Mindfulness-Based Cognitive Therapy (MBCT) is a novel treatment for depression. Our published randomized controlled trial shows that MBCT improves symptoms of late-life depression (LLD) and anxiety (LLA). We now examine whether continuation sessions of MBCT (MBCT-C) can prevent LLD/LLA symptom recurrence. METHODS/DESIGN Following an 8-week MBCT intervention, we compared patients who attended open-label weekly 1-hour MBCT-C for another 26 weeks (n = 10) vs those who did not (n = 17) for change in depressive and anxiety symptoms. RESULTS While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). CONCLUSIONS These preliminary results suggest that MBCT-C may be somewhat beneficial for symptoms of LLA, but not for LLD. Healthcare providers should consider what is clinically feasible before investing time and resources into MBCT-C in older adults with depression and/or anxiety. This article is protected by copyright. All rights reserved.",2020,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","['Late-Life Depression and Anxiety', 'Older Adults', 'older adults with depression and/or anxiety']","['MBCT', 'MBCT intervention', 'Mindfulness-Based Cognitive Therapy (MBCT-C', 'MBCT (MBCT-C', 'Mindfulness-Based Cognitive Therapy (MBCT']","['depressive or anxiety symptom severities', 'symptoms of anxiety', 'symptoms of late-life depression (LLD) and anxiety (LLA']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0552697,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Dikaios', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, 4333 Chemin de la Côte-Sainte-Catherine, Montreal, Canada.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Escobar', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, 4333 Chemin de la Côte-Sainte-Catherine, Montreal, Canada.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Nassim', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, 4333 Chemin de la Côte-Sainte-Catherine, Montreal, Canada.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Su', 'Affiliation': 'Dept. of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Avenue des Pins, Montreal, QC, Canada.'}, {'ForeName': 'Susanna G', 'Initials': 'SG', 'LastName': 'Torres-Platas', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, 4333 Chemin de la Côte-Sainte-Catherine, Montreal, Canada.'}, {'ForeName': 'Soham', 'Initials': 'S', 'LastName': 'Rej', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, 4333 Chemin de la Côte-Sainte-Catherine, Montreal, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5360'] 2714,32525328,Can motivational messages engage individuals at-risk for gambling disorder in an online assessment?,"There is a need to better understand how to motivate individuals experiencing addiction-related concerns, such as gambling problems, to engage in help-seeking behaviors. This experiment tested whether online messages based on principles of motivational interviewing (MI) could be used to encourage individuals to complete a problem gambling screener. Participants ( N = 805) who gambled at least weekly and were not receiving treatment for gambling problems were recruited via Amazon Mechanical Turk. Participants were randomly assigned to 1 of 3 message conditions that all offered participants the choice to complete either a problem gambling screener or an alternative questionnaire focused on gambling-related attitudes. The first condition was an MI-based interactive message, the second was similar in content but was presented in a noninteractive manner, and the third was a control message that did not include motivational elements. We found that the interactive motivational message yielded significantly higher rates of screener completion (39%) than the noninteractive message (28%) or control message (29%), χ² (2, N = 805) = 8.28, p = .016, Φ = .29. This remained significant after controlling for other study variables. Controlling for message condition, participants were more likely to complete the screener if they gambled more frequently, with more money, were more psychologically distressed and interested in receiving help for gambling problems, or had ever received treatment for gambling problems. These findings provide support for the use of interactive MI-based messages to encourage individuals at-risk for experiencing problems to use helping resources. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"We found that the interactive motivational message yielded significantly higher rates of screener completion (39%) than the noninteractive message (28%) or control message (29%), χ² (2, N = 805) =",['Participants ( N = 805) who gambled at least weekly and were not receiving treatment for gambling problems were recruited via Amazon Mechanical Turk'],"['problem gambling screener or an alternative questionnaire focused on gambling-related attitudes', 'online messages based on principles of motivational interviewing (MI']",['rates of screener completion'],"[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0569756,"We found that the interactive motivational message yielded significantly higher rates of screener completion (39%) than the noninteractive message (28%) or control message (29%), χ² (2, N = 805) =","[{'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'Peter', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Whelan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Rory A', 'Initials': 'RA', 'LastName': 'Pfund', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Meyers', 'Affiliation': 'Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000591'] 2715,32525410,Optical Coherence Tomography for Coronary Bioresorbable Vascular Scaffold Implantation: A Randomized Controlled Trial.,"BACKGROUND We investigated whether optical coherence tomography (OCT) guidance would reduce nonoptimal bioresorbable vascular scaffold (BVS) deployment. METHODS This was a randomized controlled trial. Patients who required percutaneous coronary intervention for ischemic heart disease were recruited from 2 centers in Korea. The enrolled patients were randomly assigned to receive either OCT-guided BVS (Absorb; Abbott Vascular) implantation or angiography-guided BVS implantation using an optimized technique. The primary outcome was nonoptimal deployment, which was a composite outcome of the following parameters assessed by OCT: a minimal scaffold area <5 mm 2 , residual area stenosis >20%, incomplete apposition of the scaffold struts >5%, major edge dissection, or scaffold disruption. The secondary outcome was a procedural complication defined by the occurrence of no reflow, coronary perforation, or flow-limiting dissection. RESULTS Between September 2016 and January 2018, 88 patients (90 lesions) were assigned to OCT guidance, while 88 patients (89 lesions) were assigned to angiography guidance. The recruitment was prematurely terminated in March 2018 because the manufacturer stopped supplying BVS. Postprocedural OCT data were available for 88 lesions with OCT guidance and for 88 lesions with angiography guidance. There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, -3.7% [95% CI, -19.0% to 11.6%]; P =0.64). There were no procedural complications in either group. CONCLUSIONS OCT-guided BVS implantation did not reduce the incidence of nonoptimal deployment compared to that of angiography-guided BVS implantation (using optimized techniques). CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02894697.",2020,"There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, -3.7% [95% CI, -19.0% to 11.6%]; P =0.64).","['Patients who required percutaneous coronary intervention for ischemic heart disease were recruited from 2 centers in Korea', 'Coronary Bioresorbable Vascular Scaffold Implantation', 'Between September 2016 and January 2018', '88 patients (90 lesions) were assigned to OCT guidance, while 88 patients (89 lesions']","['OCT-guided BVS (Absorb; Abbott Vascular) implantation or angiography-guided BVS implantation using an optimized technique', 'Optical Coherence Tomography', 'OCT-guided BVS implantation', 'angiography guidance', 'optical coherence tomography (OCT) guidance', 'angiography-guided BVS implantation']","['nonoptimal BVS deployment', 'incidence of nonoptimal deployment', 'nonoptimal deployment, which was a composite outcome of the following parameters assessed by OCT: a minimal scaffold area <5 mm 2 , residual area stenosis >20%, incomplete apposition of the scaffold struts >5%, major edge dissection, or scaffold disruption', 'procedural complication defined by the occurrence of no reflow, coronary perforation, or flow-limiting dissection', 'procedural complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.308663,"There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, -3.7% [95% CI, -19.0% to 11.6%]; P =0.64).","[{'ForeName': 'Seung-Yul', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea (S.-Y.L.).'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea (D.-Y.K., J.-M.A., D.-W.P., S.-J.P.).'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea (D.-Y.K., J.-M.A., D.-W.P., S.-J.P.).'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea (D.-Y.K., J.-M.A., D.-W.P., S.-J.P.).'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea (D.-Y.K., J.-M.A., D.-W.P., S.-J.P.).'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea (S.-J.H., C.-M.A., J.-S.K., B.-K.K., Y.-G.K., D.C., Y.J., M.-K.H.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008383'] 2716,32525413,Effectiveness of a 12-month home-based exercise program on trunk muscle strength and spine function after lumbar spine fusion surgery: a randomized controlled trial.,"Purpose: The effectiveness of a 12-month home-exercise program on trunk muscle strength after lumbar spine fusion surgery was evaluated. Materials and methods: Three months postoperatively, 98 patients were randomized either to the exercise group (EG), with a progressive 12-month home-based exercise program, or to usual care group (UCG), with one guidance session for light home-exercises. Maximal trunk muscle strength was measured by a strain-gauge dynamometer and trunk extensor endurance was measured by Biering-Sørensen's test at baseline and after the intervention. Results: The mean change in extension strength during the intervention was 75 N in EG and 58 N in UCG. Flexion strength improved 50 N in UCG and 45 N in EG. Trunk extension/flexion strength ratio changed from 0.90 to 1.02 in EG and from 0.98 to 1.00 in UCG. In EG, Biering-Sørensen's test improved by 17 s, and in UCG, it improved by 24 s. No statistically significant between-group differences were found in any variables. Median exercise frequency in EG decreased from 2.5×/week during the first two intervention months to 1.7×/week during the last two intervention months. Conclusions: Twelve-month progressive exercise program was equally effective as usual care in improving trunk muscle strength. Home exercise adherence decreased, which may have influenced the strength changes.Implications for rehabilitationThe 12-month home-based exercise program was equally as effective as usual care after lumbar spine fusion (LSF) in improving trunk muscle strength, however, the back-specific exercises led to better trunk muscle strength balance in exercise group only.The adherence to the home based exercise program is a challenge; therefore, different techniques could be implemented to provide purposeful support for each individual in their long-term exercising.It is important to recognize those who need more individualized rehabilitation in recovery of the spine function, while others may manage with subtle intervention after LSF.",2020,"Implications for rehabilitationThe 12-month home-based exercise program was equally as effective as usual care after lumbar spine fusion (LSF) in improving trunk muscle strength, however, the back-specific exercises led to better trunk muscle strength balance in exercise group only.","['98 patients', 'lumbar spine fusion surgery']","['exercise group (EG), with a progressive 12-month home-based exercise program, or to usual care group (UCG), with one guidance session for light home-exercises', 'home-based exercise program', 'progressive exercise program', 'home-exercise program']","['Home exercise adherence', 'trunk muscle strength', 'trunk muscle strength and spine function', 'Median exercise frequency in EG', 'Flexion strength', 'Trunk extension/flexion strength ratio', 'Maximal trunk muscle strength', 'strain-gauge dynamometer and trunk extensor endurance', 'mean change in extension strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",98.0,0.011585,"Implications for rehabilitationThe 12-month home-based exercise program was equally as effective as usual care after lumbar spine fusion (LSF) in improving trunk muscle strength, however, the back-specific exercises led to better trunk muscle strength balance in exercise group only.","[{'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Ilves', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Marko H', 'Initials': 'MH', 'LastName': 'Neva', 'Affiliation': 'Department of Orthopaedics and Trauma, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, Neuromuscular Research Center, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Rehabilitation Medicine and Department of Psychiatry, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Salme', 'Initials': 'S', 'LastName': 'Järvenpää', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Central Finland Health Care District, Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Kyrölä', 'Affiliation': 'Department of Orthopaedics and Trauma, Central Finland Health Care District, Jyväskylä, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1772383'] 2717,32525517,Association of Weight-Adjusted Caffeine and β-Blocker Use With Ophthalmology Fellow Performance During Simulated Vitreoretinal Microsurgery.,"Importance Vitreoretinal surgery can be technically challenging and is limited by physiologic characteristics of the surgeon. Factors that improve accuracy and precision of the vitreoretinal surgeon are invaluable to surgical performance. Objectives To establish weight-adjusted cutoffs for caffeine and β-blocker (propranolol) intake and to determine their interactions in association with the performance of novice vitreoretinal microsurgeons. Design, Settings, and Participants This single-blind cross-sectional study of 15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting. Five simulations were performed daily for 2 days. On day 1, performance was assessed after sequential exposure to placebo, low-dose caffeine (2.5 mg/kg), high-dose caffeine (5.0 mg/kg), and high-dose propranolol (0.6 mg/kg). On day 2, performance was assessed after sequential exposure to placebo, low-dose propranolol (0.2 mg/kg), high-dose propranolol (0.6 mg/kg), and high-dose caffeine (5.0 mg/kg). Interventions Surgical simulation tasks were repeated 30 minutes after masked ingestion of placebo, caffeine, or propranolol pills during the 2 days. Main Outcomes and Measures An Eyesi surgical simulator was used to assess surgical performance, which included surgical score (range, 0 [worst] to 700 [best]), task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best]). The nonparametric Friedman test followed by Dunn-Bonferroni post hoc test was applied for multiple comparisons. Results Of 15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9). Compared with low-dose propranolol, low-dose caffeine was associated with a worse total surgical score (557.0 vs 617.0; difference, -53.0; 95% CI, -99.3 to -6.7; P = .009), a lower antitremor maneuver score (55.0 vs 75.0; difference, -12.0; 95% CI, -21.2 to -2.8; P = .009), longer intraocular trajectory (2298.6 vs 2080.7 mm; difference, 179.3 mm; 95% CI, 1.2-357.3 mm; P = .048), and increased task completion time (14.9 minutes vs 12.7 minutes; difference, 2.3 minutes; 95% CI, 0.8-3.8 minutes; P = .048). Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). Conclusions and Relevance The findings suggest that performance of novice vitreoretinal surgeons was worse after receiving low-dose caffeine alone but improved after receiving low-dose propranolol alone. Their performance after receiving propranolol alone was better than after the combination of propranolol and caffeine. These results may be helpful for novice vitreoretinal surgeons to improve microsurgical performance.",2020,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). ","['15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9', '15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting']","['placebo, low-dose propranolol', 'Postcaffeine', 'placebo, low-dose caffeine', 'propranolol and caffeine', 'caffeine', 'placebo, caffeine, or propranolol pills', 'caffeine and β-blocker (propranolol', 'propranolol']","['intraocular trajectory', 'surgical performance, which included surgical score (range, 0', 'lower antitremor maneuver score', 'total surgical score', 'task completion time', 'tremor-specific score', 'longer intraocular trajectory', 'task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best']","[{'cui': 'C1720040', 'cui_str': 'Retinal surgeon'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3217257', 'cui_str': 'Propranolol Pill'}]","[{'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",5.0,0.394633,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03). ","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Roizenblatt', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Dias Gomes Barrios Marin', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Muralha', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology and Neurosurgery, Neuroengineering and Neurocognition Laboratory, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jiramongkolchai', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Peter Louis', 'Initials': 'PL', 'LastName': 'Gehlbach', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Michel Eid', 'Initials': 'ME', 'LastName': 'Farah', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1971'] 2718,32525525,Metabolic Effects of Late Dinner in Healthy Volunteers - A Randomized Crossover Clinical Trial.,"CONTEXT Consuming calories later in the day is associated with obesity and metabolic syndrome. We hypothesized that eating a late dinner alters substrate metabolism during sleep in a manner that promotes obesity. OBJECTIVE To examine the impact of late dinner on nocturnal metabolism in healthy volunteers. DESIGN AND SETTING This is a randomized crossover trial of late dinner (LD, 22:00) versus routine dinner (RD, 18:00), with a fixed sleep period (23:00-07:00) in a laboratory setting. PARTICIPANTS 20 healthy volunteers (10 males, 10 females), aged 26.0 ± 0.6 years, BMI 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00-01:00. INTERVENTIONS An isocaloric macronutrient diet was administered on both visits. Dinner (35% daily kcal, 50% carbohydrate, 35% fat) with an oral lipid tracer ([2H31] palmitate, 15 mg/kg) was given at 18:00 on RD and 22:00 on LD. MAIN OUTCOME MEASURES Nocturnal and next-morning hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography. RESULTS LD caused a 4-hour shift in the postprandial period, overlapping with the sleep phase. Independent of this shift, the postprandial period following LD was characterized by higher glucose, a triglyceride peak delay, and lower FFA and dietary fatty acid oxidation. LD did not affect sleep architecture, but increased plasma cortisol. These metabolic changes were most pronounced in habitual earlier sleepers determined by actigraphy monitoring. CONCLUSION LD induces nocturnal glucose intolerance, and reduces fatty acid oxidation and mobilization, particularly in earlier sleepers. These effects might promote obesity if they recur chronically.",2020,"LD did not affect sleep architecture, but increased plasma cortisol.","['Healthy Volunteers', 'healthy volunteers', '20 healthy volunteers (10 males, 10 females), aged 26.0 ± 0.6 years, BMI 23.2 ± 0.7 kg/m2, accustomed to a bedtime between 22:00-01:00']","['late dinner', 'isocaloric macronutrient diet', 'Late Dinner', 'oral lipid tracer ([2H31] palmitate']","['fatty acid oxidation and mobilization', 'triglyceride peak delay, and lower FFA and dietary fatty acid oxidation', 'hourly plasma glucose, insulin, triglycerides, free fatty acids (FFAs), cortisol, dietary fatty acid oxidation, and overnight polysomnography', 'Nocturnal and next-morning', 'plasma cortisol', 'nocturnal glucose intolerance', 'nocturnal metabolism']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",20.0,0.0402215,"LD did not affect sleep architecture, but increased plasma cortisol.","[{'ForeName': 'Chenjuan', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Brereton', 'Affiliation': 'Johns Hopkins University, Baltimore, MD; Institute for Clinical and Translational Research.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schweitzer', 'Affiliation': 'Johns Hopkins University, Baltimore, MD; Institute for Clinical and Translational Research.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cotter', 'Affiliation': ""Johns Hopkins University, Baltimore, MD; Arkansas Children's Nutrition Center, Arkansas Children's Research Institute.""}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'The University of Arkansas for Medical Sciences, Little Rock, AR; Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ""Johns Hopkins University, Baltimore, MD; Arkansas Children's Nutrition Center, Arkansas Children's Research Institute.""}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Dept. of Geriatrics, Center for Translational Research in Aging and Longevity.'}, {'ForeName': 'Luu V', 'Initials': 'LV', 'LastName': 'Pham', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine.'}, {'ForeName': 'Vsevolod Y', 'Initials': 'VY', 'LastName': 'Polotsky', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Jun', 'Affiliation': 'Division of Pulmonary and Critical Care, Department of Medicine.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa354'] 2719,32525562,Changes of inflammatory cytokines/chemokines during ravidasvir plus ritonavir-boosted danoprevir and ribavirin therapy for patients with genotype 1 b hepatitis C infection.,"0BJECTIVE: This study investigated the safety and efficacy of ravidasvir (RDV) plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimens for treatment-naïve non-cirrhotic patients with hepatitis C virus (HCV) genotype 1b in mainland China. We also gained insight into HCV-host interactions during anti-HCV treatment. METHODS 16 HCV patients and 10 healthy people enrolled the study. 3 of 16 patients received 12-weeks' placebo treatment first and served as the placebo controls. All (n=16) patients received 12-weeks' RDV plus DNVr and RBV treatment. The adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST) were recorded during study. We also performed multianalyte profiling of 48 cytokines/chemokines in 16 HCV patients and 10 normal controls. RESULTS 75% patients treated with RDV plus DNVr and RBV experienced AEs. No death, treatment-related serious AEs or AEs leading to discontinuation were reported. The serum HCV-RNA levels remained extremely high in 3 placebo controls after treated with placebo. After RDV plus DNVr and RBV treatment, all patients achieved sustained virologic response (SVR) at post-treatment week 12, but 1 patient experienced viral relapse at SVR 24. The cytokine/chemokine expression pattern was markedly altered in HCV patients as compared to healthy controls. The interferon-inducible protein-10 (IP-10) decreased after anti-HCV treatment, and dramatically increased in one patient with viral relapse. CONCLUSIONS The regimen of RDV and DNVr plus RBV represents a highly safe and effective treatment option for HCV patients in mainland China. The IP-10 has the potential to be an indicator of innate immune viral recognition. This article is protected by copyright. All rights reserved.",2020,"The adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST) were recorded during study.","['patients with genotype 1 b hepatitis C infection', '16 HCV patients and 10 healthy people enrolled the study', '16 HCV patients and 10 normal controls', 'treatment-naïve non-cirrhotic patients with hepatitis C virus (HCV) genotype 1b in mainland China', 'HCV patients in mainland China']","[""12-weeks' RDV plus DNVr and RBV treatment"", 'ravidasvir (RDV) plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimens', 'placebo', 'ravidasvir plus ritonavir-boosted danoprevir and ribavirin therapy', 'RDV and DNVr plus RBV']","['serum HCV-RNA levels', 'cytokine/chemokine expression pattern', 'sustained virologic response (SVR', 'adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST', 'viral relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1609888', 'cui_str': '(E)-1-(2,3,6-trimethylphenyl)buta-1,3-diene'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4508633', 'cui_str': 'ravidasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2973564', 'cui_str': 'danoprevir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0035691', 'cui_str': 'RNA virus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",75.0,0.0187822,"The adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST) were recorded during study.","[{'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Xiaoxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University.'}]",Journal of medical virology,['10.1002/jmv.26161'] 2720,32520623,Mineralocorticoid Receptor Antagonists for Hypertension Management in Advanced Chronic Kidney Disease: BLOCK-CKD Trial.,"Spironolactone, a steroidal mineralocorticoid receptor antagonist, is recommended as add-on therapy for treatment-resistant/uncontrolled hypertension. However, caution is advised in patients with advanced chronic kidney disease (CKD) due to an increased risk for hyperkalemia. KBP-5074 is a nonsteroidal mineralocorticoid receptor antagonist under investigation for the treatment of treatment-resistant and uncontrolled hypertension in patients with moderate-to-severe CKD. BLOCK-CKD is a phase 2, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with stage 3B/4 CKD (estimated glomerular filtration rate ≥15 and ≤44 mL/[min·1.73 m 2 ]) and resistant hypertension (trough cuff seated systolic blood pressure ≥140 mm Hg, despite treatment with maximally tolerated doses of 2 or more antihypertensive medicines with complementary mechanisms). Patients (n=240) will be randomized 1:1:1 to once-daily treatment with KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo, stratified by estimated glomerular filtration rate (≥30 versus <30 mL/[min·1.73 m 2 ]) and systolic blood pressure (≥160 versus <160 mm Hg). Approximately 30% of enrolled patients should have an estimated glomerular filtration rate of 15 to 29 mL/(min·1.73 m 2 ). The primary efficacy analysis is the change in trough cuff seated systolic blood pressure from baseline to day 84 for the KBP-5074 doses compared with placebo. Changes in urinary albumin-creatinine ratio will be assessed along with changes in serum potassium/incidence of hyperkalemia and changes in estimated glomerular filtration rate and serum creatinine. BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD. Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT03574363.",2020,BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD.,"['patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD', 'patients with stage 3B/4 CKD (estimated glomerular filtration rate ≥15 and ≤44 mL/[min·1.73 m 2 ]) and resistant hypertension (trough cuff seated systolic blood pressure ≥140 mm\u2009Hg, despite treatment with maximally tolerated doses of 2 or more antihypertensive medicines with complementary mechanisms', 'Patients (n=240', 'Advanced Chronic Kidney Disease', 'patients with moderate-to-severe CKD', 'patients with advanced chronic kidney disease (CKD']","['KBP-5074', 'Spironolactone', 'KBP-5074 0.25 mg, KBP-5074 0.5 mg, or placebo', 'Mineralocorticoid Receptor Antagonists', 'placebo']","['blood pressure', 'urinary albumin-creatinine ratio', 'systolic blood pressure', 'glomerular filtration rate', 'trough cuff seated systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0082584', 'cui_str': 'FK-506-Binding Protein'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}]",240.0,0.422527,BLOCK-CKD will determine whether the addition of KBP-5074 will effectively lower blood pressure without an increased risk of hyperkalemia in patients who are not candidates for steroidal mineralocorticoid receptor antagonists due to advanced CKD.,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'From the Department of Medicine, American Heart Association Comprehensive Hypertension Center, The University of Chicago Medicine, IL (G.B.).'}, {'ForeName': 'Y Fred', 'Initials': 'YF', 'LastName': 'Yang', 'Affiliation': 'KBP Biosciences, Princeton, NJ (Y.F.Y.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15199'] 2721,32520644,Comparison of 10 vs. 20 min neuromuscular training for the prevention of lower extremity injuries in male youth football: A cluster randomised controlled trial.,"The aim of this study was to compare the effects of 20 min neuromuscular training with a programme of 10 min in youth football players. 342 (15.4 ± 1.7 years) male football players from 18 teams were included, and cluster-randomized by team into two intervention groups. Both groups performed an injury prevention programme twice a week over five months using the same exercises but a different duration. The first intervention group (INT10, n = 175) performed the programme for 10 min, the second intervention group (INT20, n = 167) for 20 min. Primary outcomes were lower extremity (LE) injuries. Secondary outcomes were injury type, severity, mechanism and compliance to the intervention. 13 teams with 185 players were included for final analysis. No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism. The results show that performing preventive exercises for 10 min is no less effective than 20 min in youth football players. Shorter training sessions can, therefore, be effectively used for injury prevention. TRIAL REGISTRATION DRKS00015282.",2020,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","['1.7\xa0years', 'male football players from 18 teams', 'youth football players', '13 teams with 185 players were included for final analysis', '342 (15.4\xa0±', 'male youth football']","['20\xa0min neuromuscular training', 'neuromuscular training']","['lower extremity (LE) injuries', 'incidence rate ratio of the lower extremities', 'injury type, severity, mechanism and compliance to the intervention', 'INT10']","[{'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C4517579', 'cui_str': '15.4'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0885356,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","[{'ForeName': 'Anna Lina', 'Initials': 'AL', 'LastName': 'Rahlf', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}]",Journal of sports sciences,['10.1080/02640414.2020.1776459'] 2722,32520654,Effects of an Individualized Active Aging Counseling Intervention on Mobility and Physical Activity: Secondary Analyses of a Randomized Controlled Trial.,"Objectives: The aim of this study was to report preplanned secondary analyses of the effects of a 12-month individualized active aging counseling intervention on six mobility and physical activity outcomes. Methods: A two-arm, single-blinded randomized controlled trial was conducted among 75- and 80-year-old community-dwelling people. The intervention group (IG, n = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity. The control group (CG, n = 103) received general health information. Data were analyzed with generalized estimating equations. Results: Physical performance improved in the IG more than that in the CG (group by time p = .022), self-reported physical activity increased in both groups (time p = .012), and autonomy in outdoor mobility declined in the IG and was enhanced in the CG (group by time p = .011). No change was observed for life-space mobility, proportion of persons perceiving difficulty walking 2 km, or monitored physical activity. Discussion: Individualized counseling aiming at increasing self-selected out-of-home activity had nonsystematic effects on mobility and positively affected physical performance only.",2020,Results: Physical performance improved in the IG more than that in the CG (group by time p = .022),['75- and 80-year-old community-dwelling people'],"['Individualized counseling', 'Individualized Active Aging Counseling Intervention', 'intervention group (IG, n = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity', 'individualized active aging counseling intervention', 'CG', 'general health information']","['six mobility and physical activity outcomes', 'autonomy in outdoor mobility', 'physical activity', 'life-space mobility, proportion of persons perceiving difficulty walking 2\xa0km, or monitored physical activity', 'Physical performance', 'Mobility and Physical Activity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0311394', 'cui_str': 'Difficulty walking'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.034241,Results: Physical performance improved in the IG more than that in the CG (group by time p = .022),"[{'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Siltanen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pynnönen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': '37786 University of Thessaly , Greece.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Karavirta', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Milla J', 'Initials': 'MJ', 'LastName': 'Saajanaho', 'Affiliation': 'University of Jyvaskyla , Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'University of Jyvaskyla , Finland.'}]",Journal of aging and health,['10.1177/0898264320924258'] 2723,32520696,Lipid profile results after cardiovascular prevention programme: Euroaction model in Spain.,"BACKGROUND Cardiovascular prevention and rehabilitation programmes (CVPRP) are an established model of care designed to improve risk factor management. They have been successfully implemented in a variety of settings, in patients with coronary heart disease (CHD). OBJECTIVE To assess the long term impact of a nurse-coordinated, multidisciplinary, CVPRP in patients with CHD in the reduction of lipid profile and medication prescription in clinical practice. METHOD The study used an analytical, experimental, population based, prospective and longitudinal design. In Spain, the study was conducted in the Valencian Community, including two randomized hospitals. Coronary patients were prospectively and consecutively identified in both hospitals. The intervention hospital carried out an 8-week CVPRP. RESULTS The proportion of patients achieving improved standards of preventive care increased in the intervention hospital compared with the usual care hospital, mainly regarding LDL-C concentrations. Furthermore, an increased prescription of statins was found in the intervention group. However, there were no statistically significant differences in triglycerides and glucose levels. CONCLUSION The EUROACTION nurse-led CVPRP enabled coronary patients to control lipid profile to the European targets. A large proportion of patients were prescribed statin therapy as cardioprotective medication with favorable changes in medication for coronary patients. To improve the potential for cardiovascular prevention, we need local preventive cardiology programmes adapted to the health policy of individual countries.",2020,"The proportion of patients achieving improved standards of preventive care increased in the intervention hospital compared with the usual care hospital, mainly regarding LDL-C concentrations.","['Spain', 'Coronary patients were prospectively and consecutively identified in both hospitals', 'patients with CHD in the reduction of lipid profile and medication prescription in clinical practice', 'patients with coronary heart disease (CHD']","['statin therapy', 'Cardiovascular prevention and rehabilitation programmes (CVPRP']","['triglycerides and glucose levels', 'proportion of patients achieving improved standards of preventive care', 'prescription of statins']","[{'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0033081', 'cui_str': 'Drug prescription'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]",,0.0148544,"The proportion of patients achieving improved standards of preventive care increased in the intervention hospital compared with the usual care hospital, mainly regarding LDL-C concentrations.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Buigues', 'Affiliation': 'Department of Nursing, University of Valencia. Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Queralt', 'Affiliation': 'Department of Nursing, University of Valencia. Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'De Velasco', 'Affiliation': 'Cardiology Service, Hospital General Universitario, Valencia. Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Salvador-Sanz', 'Affiliation': 'Cardiology Department, Valencian Institute of Oncology Foundation, Valencia. Spain.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'National Institute for Prevention and Cardiovascular Health, National University of Ireland - Galway. Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'National Institute for Prevention and Cardiovascular Health, National University of Ireland - Galway. Ireland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Trapero', 'Affiliation': 'Department of Nursing, University of Valencia. Spain.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530320666200610161344'] 2724,32530462,Impact of Reactogenicity After Two Doses of Recombinant Zoster Vaccine Upon Physical Functioning and Quality of Life: An Open Phase III Trial in Older Adults.,"BACKGROUND Herpes zoster may significantly impact quality of life (QoL) in older adults. The recombinant zoster vaccine (RZV) is efficacious in adults aged ≥50 and older and is associated with increased reactogenicity compared to placebo. We report here on the impact of reactogenicity of the second RZV dose on the QoL and physical functioning (PF) of vaccine recipients, and summarize findings following both doses. METHOD In this single-arm study, 401 adults aged ≥50 and older were enrolled to receive two RZV doses 2 months apart. Change in mean Short Form Survey-36 (SF-36) PF and EuroQol-5 Dimension (EQ-5D) scores, reactogenicity, safety, productivity loss, and healthcare resource utilization were evaluated. RESULTS In total, 391 (97.5%) participants received dose 2. Post-dose 2, the most common solicited local symptoms were injection site pain (75.1%), erythema (22.4%), and swelling (13.9%), and the most common systemic symptoms were fatigue (46.3%), headache (37.5%), and myalgia (32.9%). Grade 3 solicited (local and systemic) adverse events were reported by 61 (15.6%) participants and were associated with a transient clinically significant decrease in SF-36 PF score on Days 1-2 post-dose 2 that recovered by Day 3. Overall, no clinically important reduction in mean SF-36 PF scores was observed from baseline to post-dose 2 (mean change -0.4), and no quality-adjusted-life-year loss was recorded. CONCLUSIONS Overall, QoL and PF of RZV vaccinees were not affected by vaccine-related reactogenicity. A transient reduction was observed in the first 2 days after RZV vaccination in individuals with Grade 3 adverse events. No safety concerns were identified.",2020,The recombinant zoster vaccine (RZV) is efficacious in adults aged ≥50 and older and is associated with increased reactogenicity compared to placebo.,"['401 adults aged ≥50 and older', 'Older Adults', 'older adults', 'adults aged ≥50 and older']","['recombinant zoster vaccine (RZV', 'Recombinant Zoster Vaccine', 'placebo']","['headache', 'swelling', 'SF-36 PF score', 'Grade 3 solicited ', 'myalgia', 'mean Short Form Survey-36 (SF-36) PF and EuroQol-5 Dimension (EQ-5D) scores, reactogenicity, safety, productivity loss, and healthcare resource utilization', 'Reactogenicity', 'mean SF-36 PF scores', 'local and systemic) adverse events', 'erythema', 'Overall, QoL and PF of RZV vaccinees', 'Physical Functioning and Quality of Life', 'injection site pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",401.0,0.194401,The recombinant zoster vaccine (RZV) is efficacious in adults aged ≥50 and older and is associated with increased reactogenicity compared to placebo.,"[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, North Carolina.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The Corvallis Clinic, Oregon.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Riley', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Woo', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Grupping', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa127'] 2725,32530472,Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.,"Importance Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration ClinicalTrials.gov Identifier: NCT02127671.",2020,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. ","['Persons With Serious Mental Illness', 'adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs', 'adults with serious mental illness', '398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants', '269 participants randomized (mean [SD] age', 'Importance\n\n\nPersons with serious mental illness', '48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder', 'December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland']","['Comprehensive Cardiovascular Risk Reduction Intervention', 'multifaceted intervention incorporating behavioral counseling, care coordination, and care management']","['mean (SD) baseline FRS', 'FRS', 'change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event', 'overall cardiovascular disease risk', 'cardiovascular disease mortality rate', 'mean (SD) FRS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",269.0,0.170462,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. ","[{'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Faith B', 'Initials': 'FB', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Towson, Maryland.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Jeanne B', 'Initials': 'JB', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Heller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Crum', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7247'] 2726,32530518,"Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study.","The programmed intermittent epidural bolus technique has shown superiority to continuous epidural infusion techniques, with or without patient-controlled epidural analgesia for pain relief, reduced motor block and patient satisfaction. Many institutions still use patient-controlled epidural analgesia without a background infusion, and a comparative study between programmed intermittent epidural bolus and patient-controlled epidural analgesia without a background infusion has not yet been performed. We performed a randomised, two-centre, double-blind, controlled trial of these two techniques. The primary outcome was the incidence of breakthrough pain requiring a top-up dose by an anaesthetist. Secondary outcomes included: motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes. We recruited 130 nulliparous women who received initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75 µg·ml -1 . The programmed intermittent epidural bolus group had a programmed bolus of 10 ml every hour, with on-demand patient-controlled epidural analgesia boluses of 5 ml with a 20 min lockout, and the patient-controlled epidural analgesia group had a 5 ml bolus with a 12 min lockout interval; the potential maximum volume per hour was the same in both groups. The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively. There was a significant difference in motor block (modified Bromage score ≤ 4) frequency between groups, programmed intermittent epidural bolus group 1 (1.6%) vs. patient-controlled epidural analgesia group 8 (13.1%); p = 0.015. The programmed intermittent epidural bolus group had greater local anaesthetic consumption with fewer patient-controlled epidural analgesia boluses. Patient satisfaction scores and obstetric or neonatal outcomes were not different between groups. In conclusion, we found that a programmed intermittent epidural bolus technique using 10 ml programmed boluses and 5 ml patient-controlled epidural analgesia boluses was superior to a patient-controlled epidural analgesia technique using 5 ml boluses and no background infusion.",2020,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.",['130 nulliparous women who received'],"['initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75\xa0µg·ml -1 ', 'Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia']","['motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes', 'motor block', 'local anaesthetic consumption', 'Patient satisfaction scores and obstetric or neonatal outcomes', 'incidence of breakthrough pain requiring a top-up dose by an anaesthetist', 'frequent breakthrough pain']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",130.0,0.136129,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roofthooft', 'Affiliation': 'Department of Anaesthesiology, GZA Sint Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barbé', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schildermans', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cromheecke', 'Affiliation': 'Department of Anaesthesiology, ZNA Middelheim Hospital, Antwerp, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Devroe', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Department of I-Biostat, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}]",Anaesthesia,['10.1111/anae.15149'] 2727,32530523,"Patient-reported outcomes after 10-year follow-up of intensive, multifactorial treatment in individuals with screen-detected type 2 diabetes: the ADDITION-Europe trial.","AIMS To present the longer-term impact of multifactorial treatment of type 2 diabetes on self-reported health status, diabetes-specific quality of life, and diabetes treatment satisfaction at 10-year follow up of the ADDITION-Europe trial. METHODS The ADDITION-Europe trial enrolled 3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006. Participants were randomized at general practice level to intensive treatment or to routine care . The trial ended in 2009 and a 10-year follow-up was performed at the end of 2014. We measured self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire) at different time points during the study period. A mixed-effects model was applied to estimate the effect of intensive treatment (intention-to-treat analyses) on patient-reported outcome measures for each centre. Centre-specific estimates were pooled using a fixed effects meta-analysis. RESULTS There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01 (95% CI -0.03, 0.01); Physical Composite Score (36-item Short-Form Health Survey): -0.27 (95% CI -1.11, 0.57), Audit of Diabetes-Dependent Quality of Life questionnaire: -0.01 (95% CI -0.11, 0.10); and Diabetes Treatment Satisfaction Questionnaire: -0.20 (95% CI -0.70, 0.29)]. CONCLUSIONS Intensive, multifactorial treatment of individuals with screen-detected type 2 diabetes did not affect self-reported health status, diabetes-specific quality of life, or diabetes treatment satisfaction at 10-year follow-up compared to routine care.",2020,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"['3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006', 'individuals with screen-detected type 2 diabetes']",['intensive treatment or to routine care '],"['self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire', 'Physical Composite Score (36-item Short-Form Health Survey', 'health status, diabetes-specific quality of life, or diabetes treatment satisfaction', 'Audit of Diabetes-Dependent Quality of Life questionnaire', 'Diabetes Treatment Satisfaction Questionnaire: -0.20', 'health status, diabetes-specific quality of life, and diabetes treatment satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3057.0,0.0852594,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"[{'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'G E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14342'] 2728,31805571,"A Prospective, Open-Label Comparison of Tamsulosin plus Serenoa repens and Bovine Colostrum versus Tamsulosin Alone in the Treatment of Benign Prostatic Hyperplasia.","OBJECTIVE To compare the efficacy and safety of oral supplementation with Serenoa repens (SR) and bovine colostrum (BC) plus tamsulosin (TAM) versus TAM alone over 12 months in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS Between February 2018 and February 2019, men with symptomatic BPH (IPSS ≥10) were prospectively recruited. This prospective, open-label, 12-month study included two different protocols: (1) group A, SR 320 mg/day + BC 30 mg/day + TAM 0.4 mg/day, and (2) group B, TAM 0.4 mg/day only. RESULTS Overall, 148 patients entered the study, 76 in group A and 72 in group B. At 12 months, the total IPSS had decreased by 5.5 with TAM + SR + BC and by 5.1 with TAM only (p = 0.21). However, when the total IPSS was divided into storage and voiding subscores, at 6 months the storage symptoms had improved significantly more with TAM + SR + BC (-1.6 vs. -0.9 with TAM only, p = 0.02), with the benefit persisting also at the 1-year evaluation (-1.8 vs. -0.8, p = 0.02). Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of -2.5 ± 0.2 for TAM + SR + BC versus -1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of -2.9 ± 0.4 for TAM + SR + BC versus -2.1 ± 0.4 for TAM at 12 months (p = 0.04). Conversely, no significant differences were found in maximal urinary flow rate (p = 0.38), postvoid residual volume (p = 0.12), prostate-specific antigen (p = 0.41), and prostate volume (p = 0.16). CONCLUSION Combination treatment with SR and BC plus TAM was shown to be more effective than treatment with TAM only in improving IPSS storage and QoL subscores in BPH patients after 6 months and up to 12 months of treatment.",2020,"Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of -2.5 ± 0.2 for TAM + SR + BC versus -1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of -2.9 ± 0.4 for TAM + SR + BC versus -2.1 ± 0.4 for TAM at 12 months (p = 0.04).","['men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH', 'Benign Prostatic Hyperplasia', 'Between February 2018 and February 2019, men with symptomatic BPH (IPSS ≥10', '148 patients entered the study, 76 in group A and 72 in group B']","['SR 320 mg/day + BC 30 mg/day + TAM', 'TAM + SR + BC', 'oral supplementation with Serenoa repens (SR) and bovine colostrum (BC) plus tamsulosin (TAM', 'SR and BC plus TAM', 'Tamsulosin plus Serenoa repens and Bovine Colostrum versus Tamsulosin Alone', 'TAM', 'TAM 0.4 mg/day only', 'TAM alone']","['IPSS QoL subscore', 'storage and voiding subscores', 'maximal urinary flow rate', 'prostate volume', 'TAM + SR + BC', 'postvoid residual volume', 'LUTS-related quality of life (QoL', 'efficacy and safety', 'IPSS storage and QoL subscores', 'prostate-specific antigen', 'total IPSS']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517457', 'cui_str': '0.4'}]","[{'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0429784', 'cui_str': 'Maximal urinary flow rate'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0210099,"Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of -2.5 ± 0.2 for TAM + SR + BC versus -1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of -2.9 ± 0.4 for TAM + SR + BC versus -2.1 ± 0.4 for TAM at 12 months (p = 0.04).","[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Di Maida', 'Affiliation': 'Department of Urology, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy, fabrizio.dimaida@unifi.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Department of Urology, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rubino', 'Affiliation': 'Nutritional Biology, Second University of Naples, Primo Policlinico, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Minervini', 'Affiliation': 'Department of Urology, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Carini', 'Affiliation': 'Department of Urology, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Siena', 'Affiliation': 'Department of Urology, University of Florence, Unit of Oncologic Minimally Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.'}]",Urologia internationalis,['10.1159/000503735'] 2729,31813317,Comparing face-to-face and videoconference completion of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke.,"INTRODUCTION Videoconferencing may help address barriers associated with poor access to post-stroke cognitive screening. However, the equivalence of videoconference and face-to-face administrations of appropriate cognitive screening tools needs to be established. We compared face-to-face and videoconference administrations of the Montreal Cognitive Assessment (MoCA) in community-based survivors of stroke. We also evaluated whether participant characteristics (e.g. age) influenced equivalence. METHODS We used a randomised crossover design (two-week interval). Participants were recruited through community advertising and use of a stroke-specific database. Both sessions were conducted by the same researcher in the same location. Videoconference sessions were conducted using Zoom. A repeated-measures t- test, intraclass correlation coefficient (ICC), Bland-Altman plot and multivariate regression modelling were used to establish equivalence. RESULTS Forty-eight participants (26 men, M age  = 64.6 years, standard deviation ( SD ) = 10.1; M time since stroke  = 5.2 years, SD  = 4.0) completed the MoCA face-to-face and via videoconference on average 15.8 ( SD  = 9.7) days apart. Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance. However, the ICC was low (0.615), and the Bland-Altman plot indicated wide limits of agreement, indicating variability between sessions. DISCUSSION Our findings provide preliminary evidence to support the use of videoconference to administer the MoCA following stroke. However, further research into the test-retest reliability of scores derived from the MoCA is needed in this population. Administering the MoCA via videoconference holds potential to ensure that all stroke survivors undergo cognitive screening, in line with recommended clinical practice.",2019,"Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance.","['Forty-eight participants (26 men, M age \u2009=\u200964.6 years, standard deviation ( SD )\u2009=\u200910.1; M time since stroke \u2009=\u20095.2 years, SD \u2009=\u20094.0) completed the MoCA face-to-face and via videoconference on average 15.8 ( SD \u2009=\u20099.7) days apart', 'community-based survivors of stroke', 'Participants were recruited through community advertising and use of a stroke-specific database']","['MoCA via videoconference', 'videoconference administrations of the Montreal Cognitive Assessment (MoCA', 'Montreal Cognitive Assessment (MoCA', 'Videoconference sessions', 'videoconference']",['MoCA performance'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",48.0,0.0333148,"Participants did not perform systematically better in a particular condition, and no participant variable predicted difference in MoCA performance.","[{'ForeName': 'Jodie E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Cadilhac', 'Affiliation': 'Stroke & Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Australia.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Gardner', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Ponsford', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Bhalla', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}, {'ForeName': 'Renerus J', 'Initials': 'RJ', 'LastName': 'Stolwyk', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19890788'] 2730,31825926,"Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial.","INTRODUCTION Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new treatment modality for erectile dysfunction (ED). Our aim was to evaluate the treatment outcome of Li-ESWT for ED in single-blind, placebo controlled, randomized clinical trial. METHODS Sixty patients were randomized into 2 age-matched groups: Group A - treatment and Group B - placebo. Treatment consisted of 4 sessions on the PiezoWave2 unit (R. Wolf and ELvation Medical). Effectiveness was assessed according to the International Index of Erectile Function 5 (IIEF-5), Erectile Hardness Score (EHS), questions 2 and 3 of the Sexual Encounter Profile (SEP 2, SEP 3), and Global Assessment Question (GAQ) scores at baseline and 4 and 12 weeks after treatment. We evaluated patient's and partner's subjective satisfaction. RESULTS A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient's satisfaction (p < 0.001) and partner's satisfaction (p < 0.001). CONCLUSIONS The randomized single-blind study confirms that Li-ESWT significantly improves erectile function.",2020,"A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient's satisfaction (p < 0.001) and partner's satisfaction (p < 0.001). ",['Sixty patients were randomized into 2 age-matched groups'],"['PiezoWave2 unit (R. Wolf and ELvation Medical', 'Low-intensity extracorporeal shock wave therapy (Li-ESWT', 'Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves', 'Group A - treatment and Group B - placebo', 'Li-ESWT', 'placebo']","[""partner's satisfaction"", ""patient's satisfaction"", 'International Index of Erectile Function 5 (IIEF-5), Erectile Hardness Score (EHS), questions 2 and 3 of the Sexual Encounter Profile (SEP 2, SEP 3), and Global Assessment Question (GAQ) scores', 'erectile function', 'EHS', 'quality of erection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",60.0,0.132442,"A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient's satisfaction (p < 0.001) and partner's satisfaction (p < 0.001). ","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Sramkova', 'Affiliation': 'Department of Sexology, University Hospital and Department of Traumatology, Masaryk University, Brno, Czechia, sramkova.t@gmail.com.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Motil', 'Affiliation': 'EURED Urology, Andrology Center, Brno, Czechia.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Jarkovsky', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czechia.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Sramkova', 'Affiliation': 'Department of Urology, St. Anna Hospital, Brno, Czechia.'}]",Urologia internationalis,['10.1159/000504788'] 2731,30820037,Educational delay and attainment in persons with neurofibromatosis 1 in Denmark.,"Most research on psychosocial consequences of neurofibromatosis type 1 (NF1) has focused on the relationship between disease factors and cognitive functioning. NF1 may impair domains of learning and attention, resulting in low academic performance. This study is the first nationwide population-based cohort study to investigate educational attainment and delay in completing mandatory school by persons with NF1. Educational information was collected from 550 persons at the age of 30 (born 1965-1984). They were diagnosed with NF1 in Denmark and compared to a cohort of NF1-free persons matched on gender and age (n = 4295). Multinomial logistic models were applied to estimate odds ratios (ORs) for obtaining short (≤9 years) or medium (10-12 years) education compared to long education (>12 years) by the age of 30 years. We calculated the probability of graduating 9 th year of mandatory school at different ages in 932 persons with NF1 and 7962 NF1-free persons (born 1965-2000) using quantile regression. The OR of educational completion for short- and medium-term education was three fold (95% CI 2.55-3.99) and 1.29 fold (95% CI 0.99-1.69) higher, respectively, for persons with NF1 than NF1-free persons after adjusting for birth year, gender, psychiatric and somatic morbidity and mother's education. Persons with NF1 were significantly delayed in graduating mandatory school education compared to NF1-free persons. When 90% of persons have graduated, persons with NF1 were 1.2 times older than the NF1-free persons. Experiencing delays in mandatory school likely affect further educational achievements and may impair employment and entering work force.",2019,"The OR of educational completion for short- and medium-term education was three fold (95% CI 2.55-3.99) and 1.29 fold (95% CI 0.99-1.69) higher, respectively, for persons with NF1","['persons with neurofibromatosis 1 in Denmark', '932 persons with NF1 and 7962\u2009NF1-free persons (born 1965-2000) using quantile regression', 'persons with NF1', '550 persons at the age of 30 (born 1965-1984', 'NF1-free persons matched on gender and age (n\u2009=\u20094295']",[],['graduating mandatory school education'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",[],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}]",,0.0157858,"The OR of educational completion for short- and medium-term education was three fold (95% CI 2.55-3.99) and 1.29 fold (95% CI 0.99-1.69) higher, respectively, for persons with NF1","[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Doser', 'Affiliation': 'Survivorship Unit, Danish Cancer Society Research Center, Copenhagen, Denmark. kdoser@cancer.dk.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Kenborg', 'Affiliation': 'Childhood Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth Wreford', 'Initials': 'EW', 'LastName': 'Andersen', 'Affiliation': 'Survivorship Unit, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Pernille Envold', 'Initials': 'PE', 'LastName': 'Bidstrup', 'Affiliation': 'Survivorship Unit, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Kroyer', 'Affiliation': 'Childhood Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Hove', 'Affiliation': 'The RAREDIS Database, Centre for Rare Diseases, Copenhagen University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Østergaard', 'Affiliation': 'Center for Rare Disease, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sven Asger', 'Initials': 'SA', 'LastName': 'Sørensen', 'Affiliation': 'Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Survivorship Unit, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mulvihill', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Jeanette Falck', 'Initials': 'JF', 'LastName': 'Winther', 'Affiliation': 'Childhood Cancer Research Group, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Oksbjerg', 'Initials': 'SO', 'LastName': 'Dalton', 'Affiliation': 'Survivorship Unit, Danish Cancer Society Research Center, Copenhagen, Denmark.'}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0359-8'] 2732,32525955,Simulation-based training using a vessel phantom effectively improved first attempt success and dynamic needle-tip positioning ability for ultrasound-guided radial artery cannulation in real patients: An assessor-blinded randomized controlled study.,"BACKGROUND We evaluated whether a simulation-based training with a vessel phantom improves the basic skills of a novice required for ultrasound-guided radial artery cannulation in real patients. In addition, we analysed whether repeated simulation training sets with an inter-training interval would accelerate the learning curve. METHODS From March 2019 to July 2019, twenty-one anesthesiology residents were randomized into either a simulation group (n = 11) or control group (n = 10). Residents performed a total of 84 ultrasound-guided radial artery cannulations in real patients. The simulation group participated in two sets of simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval. Trainee's performance proficiency was scored using a developed checklist, and a learning curve for each training set was constructed. To evaluate the effectiveness of our training curriculum in skill transfer, each resident performed four ultrasound-guided radial artery cannulations in real patients. The primary outcome was first attempt success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients. RESULTS The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively). A reduced number of sessions was required to reach a plateau score on the learning curve in the repeated training set compared in the first-set (7 (5-8) vs. 3 (2-4), P = 0.003, respectively). CONCLUSIONS Simulation-based training using a vessel phantom effectively improved the first attempt success rate for ultrasound-guided radial artery cannulation in real patients and the dynamic needle-tip positioning ability by ultrasound transducer in novice anesthesiology residents. In addition, repeated training curriculum accelerated the learning curve for recall skill proficiency and reduced inter-individual variability for skill acquisition. CLINICAL TRIAL REGISTRATION Clinical Research Information Service (KCT0003471, Principle investigator: Jeong Jin Min, Date of registration: 06/March/2019).",2020,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","['From March 2019 to July 2019, twenty-one anesthesiology residents', 'real patients']","['simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval', '84 ultrasound-guided radial artery cannulations', 'ultrasound-guided radial artery cannulation']","['success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients', 'success rate and dynamic needle-tip positioning ability by ultrasound transducer']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}]",,0.0489383,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0234567'] 2733,32526017,Transcranial Direct Current Stimulation (tDCS) Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial.,,2020,,['Chronic Low Back Pain'],"['Transcranial Direct Current Stimulation (tDCS', 'Therapeutic Exercise']",[],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.160382,,"[{'ForeName': 'Polyanna Gomes Lacerda', 'Initials': 'PGL', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Center for Mathematics, Computation and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP - Brazil.'}, {'ForeName': 'Vinícius Saura', 'Initials': 'VS', 'LastName': 'Cardoso', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'de Carvalho Filgueiras', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}, {'ForeName': 'Renata Hydee', 'Initials': 'RH', 'LastName': 'Hasue', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo - USP, São Paulo, SP - Brazil.'}, {'ForeName': 'Silvia Maria Amado', 'Initials': 'SMA', 'LastName': 'João', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo - USP, São Paulo, SP - Brazil.'}, {'ForeName': 'Fuad Ahmad', 'Initials': 'FA', 'LastName': 'Hazime', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}]",Physical therapy,['10.1093/ptj/pzaa105'] 2734,32526091,Interventions to prevent women from developing gestational diabetes mellitus: an overview of Cochrane Reviews.,"BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing, with approximately 15% of pregnant women affected worldwide, varying by country, ethnicity and diagnostic thresholds. There are associated short- and long-term health risks for women and their babies. OBJECTIVES We aimed to summarise the evidence from Cochrane systematic reviews on the effects of interventions for preventing GDM. METHODS We searched the Cochrane Database of Systematic Reviews (6 August 2019) with key words 'gestational diabetes' OR 'GDM' to identify reviews pre-specifying GDM as an outcome. We included reviews of interventions in women who were pregnant or planning a pregnancy, irrespective of their GDM risk status. Two overview authors independently assessed eligibility, extracted data and assessed quality of evidence using ROBIS and GRADE tools. We assigned interventions to categories with graphic icons to classify the effectiveness of interventions as: clear evidence of benefit or harm (GRADE moderate- or high-quality evidence with a confidence interval (CI) that did not cross the line of no effect); clear evidence of no effect or equivalence (GRADE moderate- or high-quality evidence with a narrow CI crossing the line of no effect); possible benefit or harm (low-quality evidence with a CI that did not cross the line of no effect or GRADE moderate- or high-quality evidence with a wide CI); or unknown benefit or harm (GRADE low-quality evidence with a wide CI or very low-quality evidence). MAIN RESULTS We included 11 Cochrane Reviews (71 trials, 23,154 women) with data on GDM. Nine additional reviews pre-specified GDM as an outcome, but did not identify GDM data in included trials. Ten of the 11 reviews were judged to be at low risk of bias and one review at unclear risk of bias. Interventions assessed included diet, exercise, a combination of diet and exercise, dietary supplements, pharmaceuticals, and management of other health problems in pregnancy. The quality of evidence ranged from high to very low. Diet Unknown benefit or harm: there was unknown benefit or harm of dietary advice versus standard care, on the risk of GDM: risk ratio (RR) 0.60, 95% CI 0.35 to 1.04; 5 trials; 1279 women; very low-quality evidence. There was unknown benefit or harm of a low glycaemic index diet versus a moderate-high glycaemic index diet on the risk of GDM: RR 0.91, 95% CI 0.63 to 1.31; 4 trials; 912 women; low-quality evidence. Exercise Unknown benefit or harm: there was unknown benefit or harm for exercise interventions versus standard antenatal care on the risk of GDM: RR 1.10, 95% CI 0.66 to 1.84; 3 trials; 826 women; low-quality evidence. Diet and exercise combined Possible benefit: combined diet and exercise interventions during pregnancy versus standard care possibly reduced the risk of GDM: RR 0.85, 95% CI 0.71 to 1.01; 19 trials; 6633 women; moderate-quality evidence. Dietary supplements Clear evidence of no effect: omega-3 fatty acid supplementation versus none in pregnancy had no effect on the risk of GDM: RR 1.02, 95% CI 0.83 to 1.26; 12 trials; 5235 women; high-quality evidence. Possible benefit: myo-inositol supplementation during pregnancy versus control possibly reduced the risk of GDM: RR 0.43, 95% CI 0.29 to 0.64; 3 trials; 502 women; low-quality evidence. Possible benefit: vitamin D supplementation versus placebo or control in pregnancy possibly reduced the risk of GDM: RR 0.51, 95% CI 0.27 to 0.97; 4 trials; 446 women; low-quality evidence. Unknown benefit or harm: there was unknown benefit or harm of probiotic with dietary intervention versus placebo with dietary intervention (RR 0.37, 95% CI 0.15 to 0.89; 1 trial; 114 women; very low-quality evidence), or probiotic with dietary intervention versus control (RR 0.38, 95% CI 0.16 to 0.92; 1 trial; 111 women; very low-quality evidence) on the risk of GDM. There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM. Pharmaceutical Possible benefit: metformin versus placebo given to obese pregnant women possibly reduced the risk of GDM: RR 0.85, 95% CI 0.61 to 1.19; 3 trials; 892 women; moderate-quality evidence. Unknown benefit or harm:eight small trials with low- to very low-quality evidence showed unknown benefit or harm for heparin, aspirin, leukocyte immunisation or IgG given to women with a previous stillbirth on the risk of GDM. Management of other health issues Clear evidence of no effect: universal versus risk based screening of pregnant women for thyroid dysfunction had no effect on the risk of GDM: RR 0.93, 95% CI 0.70 to 1.25; 1 trial; 4516 women; moderate-quality evidence. Unknown benefit or harm: there was unknown benefit or harm of using fractional exhaled nitrogen oxide versus a clinical algorithm to adjust asthma therapy on the risk of GDM: RR 0.74, 95% CI 0.31 to 1.77; 1 trial; 210 women; low-quality evidence. There was unknown benefit or harm of pharmacist led multidisciplinary approach to management of maternal asthma versus standard care on the risk of GDM: RR 5.00, 95% CI 0.25 to 99.82; 1 trial; 58 women; low-quality evidence. AUTHORS' CONCLUSIONS No interventions to prevent GDM in 11 systematic reviews were of clear benefit or harm. A combination of exercise and diet, supplementation with myo-inositol, supplementation with vitamin D and metformin were of possible benefit in reducing the risk of GDM, but further high-quality evidence is needed. Omega-3-fatty acid supplementation and universal screening for thyroid dysfunction did not alter the risk of GDM. There was insufficient high-quality evidence to establish the effect on the risk of GDM of diet or exercise alone, probiotics, vitamin D with calcium or other vitamins and minerals, interventions in pregnancy after a previous stillbirth, and different asthma management strategies in pregnancy. There is a lack of trials investigating the effect of interventions prior to or between pregnancies on risk of GDM.",2020,"There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM.","['obese pregnant women', ""We searched the Cochrane Database of Systematic Reviews (6 August 2019) with key words 'gestational diabetes' OR 'GDM"", 'women who were pregnant or planning a pregnancy, irrespective of their GDM risk status', '11 Cochrane Reviews (71 trials, 23,154 women) with data on GDM', 'women from developing gestational diabetes mellitus']","['heparin, aspirin, leukocyte immunisation or IgG', 'vitamin D + calcium + other minerals versus calcium ', 'vitamin D + calcium supplementation versus placebo', 'Omega-3-fatty acid supplementation and universal screening', 'metformin', 'fatty acid supplementation', 'Diet and exercise', 'exercise and diet, supplementation with myo-inositol, supplementation with vitamin D and metformin', 'vitamin D supplementation', 'placebo']","['diet, exercise, a combination of diet and exercise, dietary supplements, pharmaceuticals, and management of other health problems in pregnancy', 'risk of GDM']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1955832', 'cui_str': 'Review, Systematic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]",23154.0,0.298979,"There was unknown benefit or harm of vitamin D + calcium supplementation versus placebo (RR 0.33, 95% CI 0.01 to 7.84; 1 trial; 54 women; very low-quality evidence) or vitamin D + calcium + other minerals versus calcium + other minerals (RR 0.42, 95% CI 0.10 to 1.73; 1 trial; 1298 women; very low-quality evidence) on the risk of GDM.","[{'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Griffith', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Moore', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'School of Interprofessional Health Studies, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Middleton', 'Affiliation': 'Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'Robinson Research Institute, Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012394.pub3'] 2735,32526149,Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit: CRITIC Pilot Randomized Controlled Trial.,"RATIONALE Coated devices may reduce biofilm formation and reduce occurrence of device-related infections in critically ill patients. A bundle of coated devices (endotracheal tube - ETT, central venous catheter - CVC, urinary catheter - UC) simultaneously inserted may optimize benefits of coated devices in most severe patients. OBJECTIVES To assess feasibility of a randomized controlled trial on simultaneous insertion of gold-silver-palladium coated devices versus uncoated devices in severely ill patients required sequential insertion of all three devices (ETT, CVC and UC) for support in intensive care unit (ICU). METHODS Multi-center randomized controlled pilot trial. Patients that required simultaneous insertion of ETT, CVC and UC were randomized to coated versus uncoated devices which were used as necessary for up to 28 days. Primary endpoint was feasibility; secondary endpoints included estimating incidence of sepsis and device-associated infections (ventilator associated pneumonia [VAP], catheter related bloodstream infection [CRBI] and catheter related urinary tract infection [CRUTI]) for the whole population and within each group and number of days alive free of antibiotics during ICU stay. All events were adjudicated. RESULTS 103 patients (48 coated and 55 uncoated group) were included in the per-protocol analysis. There were 13 septic events in each group (26 in total), with an approximate incidence of sepsis of 32.3 (95% credible interval 22.4-44.9) per 100 patient-days. Overall incidence of VAP, CRUTI and CRBI were 15.2 (95% credible interval 7.8-26.4), 6.3 (95% credible interval 2.4-13.7), and 7.9 (95% credible interval 3.6-15.1) per 1,000 patient-days, which were not statistically different between groups. Patients in the coated group had more days alive free of antibiotics in the ICU (28.97 days versus 19.62 per 100 patient-days, mean ratio of 1.48, 95% credible interval 1.16-1.89). CONCLUSION Use of a bundle of coated devices as initial management of severely ill patients is feasible. Coated devices may be associated with more days alive and free of antibiotics. Clinical trial registered with ClinicalTrials.gov (NCT03868241).",2020,"Overall incidence of VAP, CRUTI and CRBI were 15.2 (95% credible interval 7.8-26.4), 6.3 (95% credible interval 2.4-13.7), and 7.9 (95% credible interval 3.6-15.1) per 1,000 patient-days, which were not statistically different between groups.","['severely ill patients required sequential insertion of all three devices (ETT, CVC and UC) for support in intensive care unit (ICU', 'Patients that required simultaneous insertion of ETT, CVC and UC', 'severely ill patients', 'critically ill patients', '103 patients (48 coated and 55 uncoated group) were included in the per-protocol analysis', 'Intensive Care Unit']","['simultaneous insertion of gold-silver-palladium coated devices', 'Coated Devices']","['Nosocomial Infections', 'days alive free of antibiotics', 'Overall incidence of VAP, CRUTI and CRBI', 'number of days alive free of antibiotics during ICU stay', 'incidence of sepsis and device-associated infections (ventilator associated pneumonia [VAP], catheter related bloodstream infection [CRBI] and catheter related urinary tract infection [CRUTI', '13 septic events']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0030230', 'cui_str': 'Palladium'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.532256,"Overall incidence of VAP, CRUTI and CRBI were 15.2 (95% credible interval 7.8-26.4), 6.3 (95% credible interval 2.4-13.7), and 7.9 (95% credible interval 3.6-15.1) per 1,000 patient-days, which were not statistically different between groups.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Hospital do Coracao, 206379, Research Institute, Sao Paulo, Brazil; fgzampieri@gmail.com.'}, {'ForeName': 'Neymar Elias', 'Initials': 'NE', 'LastName': 'de Oliveira', 'Affiliation': 'Hospital de Base, Rio Preto, Brazil.'}, {'ForeName': 'Antonio Paulo', 'Initials': 'AP', 'LastName': 'Nassar', 'Affiliation': 'AC Camargo Cancer Center, São Paulo, Brazil.'}, {'ForeName': 'Airton Leonardo', 'Initials': 'AL', 'LastName': 'de Oliveira Manoel', 'Affiliation': 'Hospital Paulistano, Sao Paulo, Brazil.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Grion', 'Affiliation': 'Hospital Evangélico, Londrina, Brazil.'}, {'ForeName': 'Fábio H', 'Initials': 'FH', 'LastName': 'Lacerda', 'Affiliation': 'Hospital da Lu, Sao Paulo, Brazil.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Maia', 'Affiliation': 'Hospital Nereu Ramos , Florianópolis, Brazil.'}, {'ForeName': 'Marlus', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Hospital Evangélico Cachoeiro de Itapemirim, Cachoeiro de Itapemirim, Brazil.'}, {'ForeName': 'Thiago Simões', 'Initials': 'TS', 'LastName': 'Giancursi', 'Affiliation': 'Hospital Universitário do Oeste do Paraná, Cascavel, Brazil.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'de Aquino Martins', 'Affiliation': 'Hospital Estadual Jayme dos Santos Neves, Vila da Serra, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'Hospital do Coracao, Research Institute, Sao Paulo, Brazil.'}, {'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Abait', 'Affiliation': 'Hospital do Coracao, Research Institute, Sao Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Hospital do Coracao, 206379, Research Institute, Sao Paulo, Brazil.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'University of Sao Paulo, Brazil, Chie, Intensive Care Department, Sao Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto Latino-Americano de Sepsis, Sao Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-206OC'] 2736,32526153,"Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial.","OBJECTIVE To compare the functional outcomes and length of hospital stay for patients treated with conventional physiotherapy compared to a new ankle trainer device after Weber B ankle fractures. DESIGN The patients were randomized, and then followed up at 3, 6, 12 and 52 weeks by a blinded physiotherapist. SETTING This study was done at a level 1 trauma centre. SUBJECTS One hundred and forty consecutive patients with Weber B ankle fractures that were operated on were screened for eligibility, of whom 113 were included in the study. INTERVENTIONS Conventional physiotherapy with stretching exercises, using a non-elastic band or using new ankle trainer. MAIN MEASURES Outcomes were evaluated with Olerud-Molander ankle score, Visual analogue scale for pain and ankle dorsiflexion at 3, 6, 12 and 52 weeks follow-up. Time of hospitalization and complications were registered. RESULTS Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021). At one-year follow-up, there was no difference between the groups ( P  = 0.386). The ankle trainer group had a shorter hospital stay with a mean 2.6 days (0.98) compared to 3.2 days (1.47) in the conventional group ( P  = 0.026). CONCLUSION The patients who were treated with the new ankle trainer device recovered more rapidly, evaluated by the Olerud-Molander ankle score and had a shorter stay in hospital compared to the conventional physiotherapy group. No between group differences could be observed at long-term follow-up.",2020,"RESULTS Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021).","['patients treated with', 'One hundred and forty consecutive patients with Weber B ankle fractures that were operated on were screened for eligibility, of whom 113 were included in the study']","['Conventional physiotherapy with stretching exercises, using a non-elastic band or using new ankle trainer', 'conventional physiotherapy']","['Time of hospitalization and complications', 'shorter hospital stay', 'Superior Olerud-Molander ankle scores', 'Olerud-Molander ankle score, Visual analogue scale for pain and ankle dorsiflexion', 'functional outcomes and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",140.0,0.117407,"RESULTS Superior Olerud-Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P  = 0.021).","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Molund', 'Affiliation': 'Department of Orthopaedic, Sykehuset Østfold HF, Grålum, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hellesnes', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gøran', 'Initials': 'G', 'LastName': 'Berdal', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Bernt Stray', 'Initials': 'BS', 'LastName': 'Andreassen', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Geir Stray', 'Initials': 'GS', 'LastName': 'Andreassen', 'Affiliation': 'Department of Orthopaedic, Oslo University Hospital, Oslo, Norway.'}]",Clinical rehabilitation,['10.1177/0269215520929727'] 2737,32526188,"Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials.","BACKGROUND Maternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age. METHODS We did a pooled analysis of three randomised controlled trials done in Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013). Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov, numbers NCT01430689, NCT01034254, and NCT02465190. FINDINGS 10 002 women and 9800 liveborn infants were included. Pooled efficacy of maternal vaccination to prevent infant PCR-confirmed influenza up to 6 months of age was 35% (95% CI 19 to 47). The pooled estimate was 56% (28 to 73) within the first 2 months of life, 39% (11 to 58) between 2 and 4 months, and 19% (-9 to 40) between 4 and 6 months. In women, from enrolment during pregnancy to the end of follow-up at 6 months postpartum, the vaccine was 50% (95% CI 32-63) efficacious against PCR-confirmed influenza. Efficacy was 42% (12 to 61) during pregnancy and 60% (36 to 75) postpartum. In women vaccinated before 29 weeks gestational age, the estimated efficacy was 30% (-2 to 52), and in women vaccinated at or after 29 weeks, efficacy was 71% (50 to 83). Efficacy was similar in infants born to mothers vaccinated before or after 29 weeks gestation (34% [95% CI 12 to 51] vs 35% [11 to 52]). There was no overall association between maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age. At 6 months of age, the intervention and control groups were similar in terms of underweight (weight-for-age), stunted (length-for-age), and wasted (weight-for-length). Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length. INTERPRETATION The assessment of efficacy for women vaccinated before 29 weeks gestational age might have been underpowered, because the point estimate suggests that there might be efficacy despite wide CIs. Estimates of efficacy against PCR-confirmed influenza and safety in terms of adverse birth outcomes should be incorporated into any further consideration of maternal influenza immunisation recommendations. FUNDING Bill & Melinda Gates Foundation.",2020,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length. ","['10', 'women vaccinated before 29 weeks gestational age', 'Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013', 'pregnant women and young infants', 'pregnancy', '002 women and 9800 liveborn infants were included', 'Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled']","['maternal influenza immunisation', 'maternal vaccination', 'saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali', 'trivalent inactivated influenza vaccine (IIV']","['vaccine efficacy, birth outcomes, and infant growth', 'maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age', 'Efficacy, duration of protection, birth outcomes, and infant growth', 'Efficacy', 'Growth measurements, including length and weight']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0496655', 'cui_str': 'Singleton, unspecified as to place of birth'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",10002.0,0.36851,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length. ","[{'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale Institute for Global Health, New Haven, CT, USA; Department of Internal Medicine (Infectious Diseases), Yale School of Medicine, New Haven, CT, USA; Yale School of Nursing, New Haven, CT, USA; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA. Electronic address: saad.omer@yale.edu.'}, {'ForeName': 'Dayna R', 'Initials': 'DR', 'LastName': 'Clark', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali; Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA; Department of Epidemiology, Center for Global Health Colorado School of Public Health, Aurora, CO, USA.""}, {'ForeName': 'Anushka R', 'Initials': 'AR', 'LastName': 'Aqil', 'Affiliation': 'Department of Health, Behavior, Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Steinhoff', 'Affiliation': ""Cincinnati Children's Hospital Global Health Center, Cincinnati, OH, USA.""}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA; Vaccines For All, Pune, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30479-5'] 2738,32526195,"Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial.","BACKGROUND Baloxavir marboxil (hereafter baloxavir), a selective inhibitor of influenza cap-dependent endonuclease, was approved in 2018 in the USA and Japan for the treatment of uncomplicated influenza in otherwise healthy individuals aged 12 years and older. We aimed to study the efficacy of baloxavir in outpatients at high risk of developing influenza-associated complications. METHODS We did a double-blind, placebo-controlled and oseltamivir-controlled trial in outpatients aged 12 years and older in 551 sites in 17 countries and territories. Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg), and randomly assigned (1:1:1) via an interactive web-response system to either a single weight-based dose of baloxavir (40 mg for patients weighing <80 kg and 80 mg for patients weighing ≥80 kg; baloxavir group), oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo group). All patients, investigators, study personnel, and data analysts were masked to treatment assignment until database lock. The primary endpoint was time to improvement of influenza symptoms (TTIIS) in the modified intention-to-treat population, which included all patients who received at least one dose of study drug and had RT-PCR-confirmed influenza virus infection. Safety was assessed in all patients who receved at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT02949011. FINDINGS 2184 patients were enrolled from Jan 11, 2017, to March 30, 2018, and randomly assigned to receive baloxavir (n=730), placebo (n=729), or oseltamivir (n=725). The modified intention-to-treat population included 1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group. 557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7%) had influenza A H1N1, 14 patients had a mixed infection, and 28 had infections with non-typable viruses. The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001). The median TTIIS in the oseltamivir group was 81·0 h (95% CI 69·4 to 91·5), with a difference from the baloxavir group of 7·7 h (-7·9 to 22·7). Adverse events were reported in 183 (25%) of 730 patients in the baloxavir group, 216 (30%) of 727 in the placebo group, and 202 (28%) of 721 in the oseltamivir group. Serious adverse events were noted in five patients in the baloxavir group, nine patients in the placebo group, and eight patients in the oseltamivir group; one case each of hypertension and nausea in the placebo group and two cases of transaminase elevation in the oseltamivir group were considered to be treatment related. Polymerase acidic protein variants with Ile38Thr, Ile38Met, or Ile38Asn substitutions conferring reduced baloxavir susceptibility emerged in 15 (5%) of 290 baloxavir recipients assessed for amino acid substitutions in the virus. INTERPRETATION Single-dose baloxavir has superior efficacy to placebo and similar efficacy to oseltamivir for ameliorating influenza symptoms in high-risk outpatients. The safety of baloxavir was comparable to placebo. This study supports early therapy for patients at high risk of complications of influenza to speed clinical recovery and reduce complications. FUNDING Shionogi.",2020,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"['outpatients at high risk of developing influenza-associated complications', '1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group', 'Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg', 'n=729), or oseltamivir (n=725', '14 patients had a mixed infection, and 28 had infections with non-typable viruses', 'otherwise healthy individuals aged 12 years and older', '557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7', 'outpatients aged 12 years and older in 551 sites in 17 countries and territories', 'high-risk outpatients', 'patients at high risk of complications of influenza to speed clinical recovery and reduce complications', 'patients who receved at least one dose of study drug', 'high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2', '2184 patients were enrolled from Jan 11, 2017, to March 30, 2018']","['placebo-controlled and oseltamivir', 'interactive web-response system to either a single weight-based dose of baloxavir', 'oseltamivir', 'baloxavir', 'oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo', 'baloxavir marboxil', 'Baloxavir marboxil (hereafter baloxavir', 'placebo']","['Safety', 'Adverse events', 'baloxavir susceptibility', 'median TTIIS', 'hypertension and nausea', 'safety of baloxavir', 'time to improvement of influenza symptoms (TTIIS', 'transaminase elevation', 'Serious adverse events']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0276353', 'cui_str': 'Influenza due to Influenza B virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",2184.0,0.618107,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ison', 'Affiliation': 'Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: mgison@northwestern.edu.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mitchener', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30004-9'] 2739,32526210,"Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial.","BACKGROUND Highly effective direct-acting antiviral drugs provide the opportunity to eliminate hepatitis C virus (HCV) infection, but established pathways can be ineffective. We aimed to examine whether a community pharmacy care pathway increased treatment uptake, treatment completion, and cure rates for people receiving opioid substitution therapy, compared with conventional care. METHODS This cluster-randomised trial was done in Scottish community pharmacies. Before participants were recruited, pharmacies were randomly assigned (1:1) to refer patients with evidence of HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care). Pharmacies were stratified by location. All pharmacies were trained to offer dried blood spot testing. All eligible participants had received opioid substitution therapy for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration. Neither pharmacists nor patients were masked to treatment allocation. In both groups, assessment blood samples were taken, infection with HCV was confirmed, and daily oral ledipasvir-sofosbuvir (90 mg ledipasivir plus 400 mg sofosbuvir) for 8 weeks for genotype 1 or daily oral sofosbuvir (400 mg) plus oral daclatasvir (60 mg) for 12 weeks for genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group). In the conventional care group, the patient received care at a treatment centre. Once prescribed, medication in both groups was delivered as daily modified directly observed therapy alongside opioid substitution therapy in the participants' pharmacy where treatment was observed on 6 days per week. The primary outcome was the number of patients with sustained virological response 12 weeks after completion of treatment (SVR12) as a proportion of the number of people receiving opioid substitution therapy at participating pharmacies. Participants were monitored at each visit for nausea and fatigue; other adverse events were recorded as free text. Secondary outcomes compared key points on treatment pathway between the two groups. These key points were the proportion of patients having dry blood spot testing, the proportion of patients initiating HCV treatment, the proportion of patients completing the 8 or 12 week HCV course of treatment, and the proportion of patients with sustained virological response at 12 months. This study is registered with ClinicalTrials.gov, NCT02706223. FINDINGS 56 pharmacies were randomly assigned (28 to each group; one pharmacy withdrew from the conventional care group). The 55 participating pharmacies included 2718 patients receiving opioid substitution therapy (1365 in the pharmacist-led care group and 1353 in the conventional care group). More patients met the primary endpoint of SVR12 in the pharmacist-led care group (98 [7%] of 1365) than in the conventional care group (43 [3%] of 1353; odds ratio 2·375, 95% CI 1·555-3·628, p<0·0001). More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007). The data for sustained virological response at 12 months are not reported in this study: patients remain in follow-up for this outcome. No serious adverse events were recorded. INTERPRETATION Using pharmacists to deliver an HCV care pathway made testing and treatment more accessible for patients, improved engagement, and maintained high treatment success rates. The use of this pathway could be a key part of an integrated and effective approach to HCV elimination at a community level. FUNDING Partnership between the Scottish Government, Gilead Sciences, and Bristol-Myers Squib.",2020,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","['1365 in the pharmacist-led care group and 1353 in the conventional care group', '56 pharmacies', 'patients receiving opioid substitution therapy', 'Scottish community pharmacies', '55 participating pharmacies included 2718 patients receiving', 'people receiving opioid substitution therapy, compared with conventional care', 'for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration']","['opioid substitution therapy', 'oral daclatasvir', 'genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group', 'HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care', 'daily modified directly observed therapy alongside opioid substitution therapy', 'pharmacist-led versus conventionally delivered antiviral treatment']","['sustained virological response', 'nausea and fatigue; other adverse events', 'serious adverse events', 'SVR12', 'number of patients with sustained virological response']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C3532919', 'cui_str': 'Hepatitis C virus genotype 1'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",2718.0,0.107076,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'NHS Tayside, Directorate of Public Health, Kings Cross Hospital, Dundee, UK; University of Dundee, Ninewells Hospital and Medical School, Dundee, UK. Electronic address: andrew.radley@nhs.net.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands; University of Aberdeen, Institute of Applied Health Sciences, Aberdeen, UK.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Inglis', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Barclay', 'Affiliation': 'NHS Greater Glasgow and Clyde, Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK; Glasgow Caledonian University, Department of Life Sciences, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fraser', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Foresterhill Health Campus, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30120-5'] 2740,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to the stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803'] 2741,32526235,Randomized controlled trial comparing the Franseen needle with a Fork-tip needle for EUS-guided fine-needle biopsy.,"BACKGROUND AND AIMS Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) primarily provides cytologic samples. EUS-guided fine-needle biopsy (EUS-FNB) with needles that provide histologic specimens may enhance diagnostic yield and facilitate accessory tissue staining. Several different needle designs are currently available and design superiority is unknown. We designed a randomized controlled trial (RCT) comparing 2 commonly used EUS-FNB needles in their ability to provide histologic tissue samples (primary endpoint) and to reach an accurate diagnosis (secondary endpoint). MATERIALS AND METHODS A total of 150 lesions from 134 patients (November 2018-June 2019) were randomized 1:1 between biopsies with a Franseen needle and a Fork-tip needle. Both groups were compared regarding the quality of the tissue samples and diagnostic accuracy. RESULTS Of 150 lesions, 75 were pancreatic and 75 were other solid lesions in and around the GI tract. There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histological samples, 71 out of 75 (94.7%) versus 72 out of 75 (96%), (p=1.00), an absolute difference of -1.3% (95% CI, -8.1 to 5.4%). Similarly the 2 groups were similar in the diagnostic accuracy of histological analysis, 64 out of 75 (85.3%) versus 68 out of 75 (90.7%), (p=0.45), absolute difference -5.4% (95% CI, -15.7 to 5%); and in the diagnostic accuracy of combined cytological and histological analysis, 65 out of 75 (86.7%) versus 69/75 (92%), p=0.43, absolute difference -5.3%, (95% CI, -15.2% to 4.5%). CONCLUSIONS There was no significant difference in the performance of Franseen versus Fork-tip needles. Both needles achieved a high yield of histological tissue samples and high diagnostic accuracy.",2020,"There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histological samples, 71 out of 75 (94.7%) versus 72 out of 75 (96%), (p=1.00), an absolute difference of -1.3% (95% CI, -8.1 to 5.4%).","['Of 150 lesions, 75 were pancreatic and 75 were other solid lesions in and around the GI tract', 'A total of 150 lesions from 134 patients (November 2018-June 2019']","['Franseen needle and a Fork-tip needle', 'EUS-guided fine-needle biopsy (EUS-FNB', 'Franseen needle with a Fork-tip needle for EUS-guided fine-needle biopsy', 'EUS-FNB needles', 'Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA']","['diagnostic accuracy of combined cytological and histological analysis', 'diagnostic accuracy of histological analysis', 'performance of Franseen', 'Franseen needle and the Fork-tip needle', 'quality of the tissue samples and diagnostic accuracy']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0546910', 'cui_str': 'Fork'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1292533', 'cui_str': 'Tissue specimen'}]",,0.0384466,"There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histological samples, 71 out of 75 (94.7%) versus 72 out of 75 (96%), (p=1.00), an absolute difference of -1.3% (95% CI, -8.1 to 5.4%).","[{'ForeName': 'Munish', 'Initials': 'M', 'LastName': 'Ashat', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242. Electronic address: ashatmunish@gmail.com.'}, {'ForeName': 'Jagpal S', 'Initials': 'JS', 'LastName': 'Klair', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Sydney L', 'Initials': 'SL', 'LastName': 'Rooney', 'Affiliation': 'Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Sagar J', 'Initials': 'SJ', 'LastName': 'Vishal', 'Affiliation': 'Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Arvind R', 'Initials': 'AR', 'LastName': 'Murali', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Sahar', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'El-Abiad', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Gerke', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Iowa Hospitals and Clinics, Iowa City, USA, 52242.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.05.057'] 2742,32526362,Comprehensive Aneurysm Management (CAM): An all-inclusive care trial for unruptured intracranial aneurysms.,"BACKGROUND In the absence of randomized evidence the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain. METHODS CAM is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 conservative vs curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7mm), location (anterior or posterior circulation), and age < 60. RESULTS The CAM primary outcome is: Survival without neurological dependency (mRS of < 3) at 10 years. Secondary outcome measures include: 1/ The incidence of SAH during follow-up and related morbidity and mortality; 2/ The morbidity and mortality related to EVT or surgical treatment of the UIA at one year; 3/ Overall morbidity and mortality at 1, 5 and 10 years; and when relevant: 4/ Length of hospitalization; 5/ Discharge to location other than home. The primary hypothesis for patients randomly allocated at least 2 options, one of which is conservative management is: Active UIA treatment will reduce the 10 year combined neurological morbidity and mortality (mRS >2) from 24% to 16%. At least 961 patients recruited in at least 20 centers over 4 years will be needed for the randomized portion of the study. CONCLUSION Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.",2020,Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited and treatment allocation will follow an algorithm combining clinical judgment and randomization.,"['Patients eligible for at least 2 management options', 'patients with unruptured intracranial aneurysms (UIA', 'At least 961 patients recruited in at least 20 centers over 4 years will be needed for the randomized portion of the study']",['Comprehensive Aneurysm Management (CAM'],"['Survival without neurological dependency', 'incidence of SAH during follow-up and related morbidity and mortality; 2/ The morbidity and mortality related to EVT or surgical treatment of the UIA at one year; 3/ Overall morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036001', 'cui_str': 'S-Adenosyl homocysteine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",961.0,0.113744,Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited and treatment allocation will follow an algorithm combining clinical judgment and randomization.,"[{'ForeName': 'Tim E', 'Initials': 'TE', 'LastName': 'Darsaut', 'Affiliation': 'University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Edmonton, Alberta, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cognard', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Thérapeutique du CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Januel', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Thérapeutique du CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Bourcier', 'Affiliation': 'Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, Nantes, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Boulouis', 'Affiliation': 'Service Imagerie Morphologique et Fonctionnelle, Hôpital Sainte-Anne, Paris, France.'}, {'ForeName': 'Jai Jai', 'Initials': 'JJ', 'LastName': 'Shiva Shankar', 'Affiliation': 'Department of Radiology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'J Max', 'Initials': 'JM', 'LastName': 'Findlay', 'Affiliation': 'University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': 'Department of Radiology, Service of Interventional Neuroradiology, University of Ottawa Hospitals, Civic Campus, Ottawa, Ontario, Canada.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Boccardi', 'Affiliation': 'Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Valvassori', 'Affiliation': 'Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Magro', 'Affiliation': 'Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Gentric', 'Affiliation': 'Service de Radiologie, CHU Cavale Blanche, EA 3878 GETBO, Brest, France.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Bojanowski', 'Affiliation': ""Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Chiraz', 'Initials': 'C', 'LastName': 'Chalaala', 'Affiliation': ""Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Weill', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Ange', 'Initials': 'A', 'LastName': 'Diouf', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Gevry', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Chagnon', 'Affiliation': 'Department of mathematics and statistics, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and chum Research Center (CRCHUM), Montreal, Quebec, Canada. Electronic address: jean.raymond@umontreal.ca.""}]",World neurosurgery,['10.1016/j.wneu.2020.06.018'] 2743,32526448,Exploratory study of association between blood immune markers and cognitive symptom severity in major depressive disorder: Stratification by body mass index status.,"BACKGROUND A subset of patients with Major Depressive Disorder (MDD) have shown differences relative to healthy controls in blood inflammatory and immune markers. Meanwhile, MDD and comorbid obesity appear to present with distinct biological and symptom characteristics, categorised as ""atypical"" or ""immunometabolic"" depression, although the relevant underlying biological mechanisms are still uncertain. Therefore, this exploratory study aimed to better characterise the relationship between peripheral blood immune markers and symptoms of MDD, as well as the extent to which body mass index (BMI) may alter this relationship. METHODS Linear regression analyses were performed between selected baseline characteristics including clinical scales and blood inflammatory markers in participants with MDD (n = 119) enrolled in the PREDDICT randomised controlled trial (RCT), using age, sex and BMI as covariates, and then stratified by BMI status. Specifically, the Montgomery-Åsberg Depression Rating Scale (MADRS) for symptom severity, Clinical Global Impression scale (CGI) for functional impairment, Oxford Depression Questionnaire (ODQ) for emotional blunting, and THINC integrated tool (THINC-it) for cognitive function were considered as clinical measures. RESULTS There was a significant association between basophil count and THINC-it Codebreaker mean response time (associated with complex attention, perceptual motor, executive function, and learning and memory abilities) in overweight individuals and with THINC-it Trails total response time (associated with executive function ability) in moderately obese individuals, when controlling for age, sex, and years of education. No correlation was found between any tested blood markers and MADRS, CGI or ODQ clinical measures, regardless of BMI. DISCUSSION Although the present study is exploratory, the results suggest that targeting of the immune system and of metabolic parameters might confer benefits, specifically in patients with high BMI and experiencing cognitive impairment associated with MDD. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017.",2020,"No correlation was found between any tested blood markers and MADRS, CGI or ODQ clinical measures, regardless of BMI. ","['moderately obese individuals', 'overweight individuals and with THINC-it', 'participants with MDD (n = 119) enrolled', 'patients with high BMI and experiencing cognitive impairment associated with MDD', 'major depressive disorder', 'patients with Major Depressive Disorder (MDD']",[],"['Trails total response time', 'basophil count and THINC', 'clinical scales and blood inflammatory markers', 'Montgomery-Åsberg Depression Rating Scale (MADRS) for symptom severity, Clinical Global Impression scale (CGI) for functional impairment, Oxford Depression Questionnaire (ODQ) for emotional blunting, and THINC integrated tool (THINC-it) for cognitive function', 'complex attention, perceptual motor, executive function, and learning and memory abilities', 'blood markers and MADRS, CGI or ODQ clinical measures, regardless of BMI']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",[],"[{'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0200641', 'cui_str': 'Basophil count'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0233469', 'cui_str': 'Blunted affect'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",119.0,0.0202413,"No correlation was found between any tested blood markers and MADRS, CGI or ODQ clinical measures, regardless of BMI. ","[{'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Fourrier', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia; Hopwood Centre for Neurobiology, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sampson', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Japan.'}, {'ForeName': 'K Oliver', 'Initials': 'KO', 'LastName': 'Schubert', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia; Northern Adelaide Mental Health Service, Salisbury, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie T', 'Initials': 'NT', 'LastName': 'Mills', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Bernhard T', 'Initials': 'BT', 'LastName': 'Baune', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, University of Münster, Münster, Germany; Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Melbourne, Australia; The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, VIC, Australia. Electronic address: bernhard.baune@ukmuenster.de.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.007'] 2744,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972'] 2745,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing. METHODS A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups. RESULTS A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. LIMITATIONS Findings largely relate to a female undergraduate psychology sample. CONCLUSION Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592'] 2746,32526534,Trial design of the RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs health system plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001'] 2747,32526606,Choosing vaginal birth after caesarean section: Motivating factors.,"OBJECTIVES to examine the factors that motivate women who have had a previous caesarean section to consider planning a vaginal birth. DESIGN a qualitative descriptive study with thematic analysis, drawing on interviews with women participating in a two arm, un-blinded randomised controlled trial (RCT) of midwifery continuity of care for increasing the proportion of women planning VBAC. SETTING A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia. PARTICIPANTS a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth. FINDINGS These women were committed to natural birth and drew on their previous experience of caesarean section to highlight the downside of recovery post caesarean section. Decision making for these women was complex. During the decision-making process, women individualised the information provided to balance risk and chance within the context of their own circumstance. Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. CONCLUSIONS Recovery post caesarean section is an important consideration that is under emphasised in the informed consent process. There is opportunity for midwives to contribute proactively in promoting vaginal birth for women who have experienced a previous caesarean section. IMPLICATIONS FOR PRACTICE women should be assisted to make informed choices with balanced information that includes recovery from surgical birth. Models of care that include a significant role for midwives and strategies that proactively encourage vaginal birth for women after previous caesarean section are needed.",2020,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","['A Maternity Unit attached to a district hospital in an outer metropolitan area of Sydney, Australia', 'a purposive sample of 18 women participating in an RCT who had experienced previous caesarean section and had no contraindications for vaginal birth', 'motivate women who have had a previous caesarean section to consider planning a vaginal birth', 'women who have experienced a previous caesarean section']",[],[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",[],[],18.0,0.0830958,"Supportive healthcare providers were important in motivating women towards vaginal birth and midwives were identified as being more supportive than obstetricians. ","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Canberra and ACT Government Health Directorate, Faculty of Health, Bruce, 2617, ACT, Australia. Electronic address: Deborah.davis@canberra.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'S Homer', 'Affiliation': 'Maternal and Child Health Program, Burnet Institute, Melbourne, Australia; Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clack', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Sabera', 'Initials': 'S', 'LastName': 'Turkmani', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia.'}, {'ForeName': 'Maralyn', 'Initials': 'M', 'LastName': 'Foureur', 'Affiliation': 'Centre for Midwifery, Child and Family Health, Faculty of Health, University of Technology Sydney, Australia; Hunter New England Local Health District & University of Newcastle, NSW, Australia.'}]",Midwifery,['10.1016/j.midw.2020.102766'] 2748,32526634,"Randomised phase II study of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to fluoropyrimidine, irinotecan and oxaliplatin (WJOG 6510G).","BACKGROUND Cetuximab has been shown to be clinically active when given in combination with irinotecan in patients with irinotecan-refractory metastatic colorectal cancer (mCRC). However, it has remained unclear whether panitumumab is effective when combined with irinotecan. We compared efficacies of both regimens in this randomised phase II study. PATIENTS AND METHODS Patients with wild-type KRAS exon 2 mCRC previously treated with fluorouracil-, oxaliplatin- and irinotecan-based chemotherapies were randomised (1:1) to either panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm). The primary end-point was progression-free survival (PFS). The planned sample size was 120, expecting a hazard ratio (HR) of 1.0 with non-inferiority margin of 1.3 (one-sided alpha error 0.2 and power 0.7). Major secondary end-points were overall survival (OS), response rate and safety. RESULTS From December 2011 to September 2014, 121 patients were enrolled, and 61 and 59 patients were randomised to the panitumumab and cetuximab arms, respectively (1 patient excluded). Most patients (97%) had received prior chemotherapies containing bevacizumab. The median PFS was 5.42 months in the panitumumab arm and 4.27 months in the cetuximab arm (HR = 0.64, 95% confidence interval [CI] = 0.44-0.94, P < 0.001 for non-inferiority, P = 0.058 for superiority), and median OS was 14.85 and 11.53 months (HR = 0.66, 95% CI = 0.44-1.00, P = 0.050 for superiority), respectively. The incidence of grade 3 or 4 hypomagnesaemia was higher in the panitumumab arm than that in the cetuximab arm (17% vs. 7%). CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.",2020,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","['patients with KRAS wild-type metastatic colorectal cancer refractory to', 'patients with irinotecan-refractory metastatic colorectal cancer (mCRC', 'From December 2011 to September 2014', 'patients with irinotecan-refractory mCRC', '121 patients were enrolled, and 61 and 59 patients', 'Patients with wild-type KRAS exon 2 mCRC previously treated with']","['panitumumab plus irinotecan versus cetuximab plus irinotecan', 'fluoropyrimidine, irinotecan\xa0and oxaliplatin (WJOG 6510G', 'panitumumab', 'panitumumab and cetuximab', 'panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm', 'irinotecan', 'bevacizumab', 'fluorouracil-, oxaliplatin-\xa0and irinotecan-based chemotherapies']","['median OS', 'incidence of grade 3 or 4 hypomagnesaemia', 'overall survival (OS), response rate\xa0and safety', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",121.0,0.220477,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: dsakai@cfs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroetererological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otsu', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hozumi', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.014'] 2749,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC). METHOD Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests. RESULTS In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests. CONCLUSIONS CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079'] 2750,32526688,Examining the effect of a brief psychoeducation intervention based on self-regulation model on sexual satisfaction for women with breast cancer: A randomized controlled trial.,"PURPOSE The main goal of this study was to investigate whether the Self-Regulation Model could improve sexual satisfaction for women diagnosed with breast cancer. METHODS Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran. Participants were randomly assigned to either an intervention group (n = 40) or a control group (n = 40). All participants were administered a demographic questionnaire and an Index of Sexual Satisfaction (ISS) pre-intervention, immediately post-intervention, and 1, 2, and 3 months following the intervention. The control group completed the assessments along the same time line as the intervention group. Women in the experimental group were provided three sessions of a psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies to improve their overall sexual satisfaction with sexual intercourse. Each intervention took between 60 and 90 min to administer. RESULTS The experimental and control group participants were well balanced in terms of demographic characteristics and sexual satisfaction scores before the intervention. The intervention group showed a positive increasing trend in the sexual satisfaction scores over time while the control group participants had a negative trend (p < 0.05). There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. CONCLUSION Providing a psychoeducational based intervention provided an increase of sexual satisfaction during intercourse for women diagnosed with breast cancer. The psychoeducation based intervention provided an opportunity for participants to dispel common myths regarding their disease and obtain new strategies and skills to improve their sexual satisfaction from intercourse with their partners.",2019,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. ","['women diagnosed with breast cancer', 'Adult women diagnosed with breast cancer were recruited from a hospital in Qazvin, Iran', 'women with breast cancer']","['psychoeducational based intervention', 'Self-Regulation Model', 'psychological individual intervention which included psychoeducation regarding their diagnosis and personalized intervention strategies', 'psychoeducation intervention based on self-regulation model']","['demographic characteristics and sexual satisfaction scores', 'sexual satisfaction scores', 'sexual satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0482538,"There were also statistical differences in the sexual satisfaction scores at each follow-up month (p < 0.05) adjusted for the baseline score and relevant demographical variables, showing longer term effects with a significant increase in sexual satisfaction over time. ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Frouzan', 'Initials': 'F', 'LastName': 'Olfati', 'Affiliation': 'Metabolic Diseases Research Center, School of Nursing and Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: folfati@qums.ac.ir.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Oveisi', 'Affiliation': 'Metabolic Disease Research Center, School of Medicine, Qazvin University of Medical Science, Qazvin, Iran. Electronic address: soveysi@qums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: nbahrami@qums.ac.ir.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Astrologo', 'Affiliation': 'Interpersonal Relationships & Development Laboratory, Centre for Research in Human Development, Department of Psychology, Concordia University, Montréal, QC, Canada. Electronic address: lisa.astrologo@live.ca.'}, {'ForeName': 'Yiong Huak', 'Initials': 'YH', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Unit, Yong Loo Lin School of Medicine, National University Health System, Singapore. Electronic address: yiong_huak_chan@nuhs.edu.sg.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101673'] 2751,32526771,Criteria for the determination of maximal oxygen uptake in patients newly diagnosed with cancer: Baseline data from the randomized controlled trial of physical training and cancer (Phys-Can).,"INTRODUCTION Maximal oxygen uptake ([Formula: see text]) is a measure of cardiorespiratory fitness often used to monitor changes in fitness during and after treatment in cancer patients. There is, however, limited knowledge in how criteria verifying [Formula: see text] work for patients newly diagnosed with cancer. Therefore, the aim of this study was to describe the prevalence of fulfillment of typical criteria verifying [Formula: see text] and to investigate the associations between the criteria and the test leader's evaluation whether a test was performed ""to exhaustion"". An additional aim was to establish new cut-points within the associated criteria. METHODS From the Phys-Can randomized controlled trial, 535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an incremental [Formula: see text] test on a treadmill. The test was performed before starting (neo-)adjuvant treatment and an exercise intervention. Fulfillment of different cut-points within typical criteria verifying [Formula: see text] was described. The dependent key variables included in the initial bivariate analysis were achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR). A receiver operating characteristic analysis was performed to establish cut-points for variables associated with the test leader's evaluation. Last, a cross-validation of the cut-points found in the receiver operating characteristic analysis was performed on a comparable sample of cancer patients (n = 80). RESULTS The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"". The cut-points that best predicted the test leader's evaluation were RER ≥ 1.14, RPE ≥ 18 and fR ≥ 40. Maximal heart rate and [Formula: see text] plateau was not associated with the test leader's evaluation. CONCLUSION We recommend a focus on RER (in the range between ≥1.1 and ≥1.15) and RPE (≥17 or ≥18) in addition to the test leader's evaluation. Additionally, a fR peak of ≥40 breaths/min may be a cut-point to help the test leader evaluate the degree of exhaustion. However, more research is needed to verify our findings, and to investigate how these criteria will work within a population that are undergoing or finished with cancer treatment.",2020,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","['535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an', 'cancer patients', 'patients newly diagnosed with cancer']","['incremental [Formula: see text] test on a treadmill', 'physical training and cancer (Phys-Can']","[""achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR"", 'fR peak', 'Maximal heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",535.0,0.0740939,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","[{'ForeName': 'Ann Christin Helgesen', 'Initials': 'ACH', 'LastName': 'Bjørke', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}]",PloS one,['10.1371/journal.pone.0234507'] 2752,32526832,"Effects of Particulate Matter Education on Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality among Patients with Chronic Obstructive Pulmonary Disease.","The burden of illness resulting from adverse environmental exposure is significant. Numerous studies have examined self-care behaviors among patients with chronic obstructive pulmonary disease (COPD), but seldom assess these behaviors in relation to air pollution. The study aims to examine the effects of particulate matter (PM) education on prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels among patients with COPD. A longitudinal, quasi-experimental design using a generalized estimating equation examined the effectiveness of the education intervention. Participants were 63 patients with COPD, of whom only 25 received intervention. Levels of PM 2.5 and PM 10 decreased in the first-month follow-up in the experimental group. Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control. Regarding the COPD assessment test and physical domain scores, the experimental group exhibited a greater improvement in the first-month follow-up. Scores on the psychological domain significantly changed in the sixth-month follow-up. The PM education coordinated by nurses improved the health of participants, maintaining six-month effects. Further studies should evaluate the practice barriers and effects of health education on preventive self-care behaviors regarding indoor PM among patients with COPD.",2020,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"['Participants were 63 patients with COPD, of whom only 25 received intervention', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['Particulate Matter Education', 'particulate matter (PM) education']","['psychological domain', 'Self-Care Knowledge Regarding Air Pollution, Symptom Changes, and Indoor Air Quality', 'COPD assessment test and physical domain scores', 'prevention and self-care knowledge regarding air pollution, symptom changes, and indoor PM concentration levels', 'Levels of PM 2.5 and PM 10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085760', 'cui_str': 'Indoor Air Quality'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844011', 'cui_str': '2.5'}]",63.0,0.0204067,Improvement of knowledge and prevention regarding PM in the first and third months were also greater in the experimental group compared to the control.,"[{'ForeName': 'Su-Er', 'Initials': 'SE', 'LastName': 'Guo', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Miao-Ching', 'Initials': 'MC', 'LastName': 'Chi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Su-Lun', 'Initials': 'SL', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing and Graduate Institute of Nursing, College of Nursing, Chang Gung University of Science and Technology (CGUST), Chiayi County 613016, Taiwan.'}, {'ForeName': 'Chieh-Mo', 'Initials': 'CM', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Chiayi County 613016, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114103'] 2753,32526849,Therapeutic Atmosphere in Psychotherapy Sessions.,"There is uncertainty concerning what the active ingredients in psychotherapy are. The First Experimental Study of Transference interpretations (FEST) was a randomized controlled trial of the effects of transference work (TW) in psychodynamic psychotherapy. Women with low quality of object relations (QOR) showed a large positive effect of transference work, while men with high QOR showed a slight negative effect. The present study aimed to expand the knowledge from the FEST by investigating the therapeutic atmosphere with Structural Analysis of Social Behavior (SASB). Two-way ANOVAs were conducted to investigate differences between SASB cluster scores between subgroups. The therapeutic atmosphere was characterized by Protect-Trust, Affirm-Disclose and Control-Submit. Multilevel modeling was used to assess the relationship between a therapist variable and outcomes for men and women. Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.",2020,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","['Women with low quality of object relations (QOR', 'women with low QOR and men with high QOR', 'men and women']","['Transference interpretations (FEST', 'transference work (TW']","['therapeutic atmosphere', 'SASB cluster scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205864', 'cui_str': 'Object Relations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0204514', 'cui_str': 'Structural analysis'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0323645,"Contrary to expectations, no significant differences in therapeutic atmosphere between subgroups (with or without TW in women with low QOR and men with high QOR) were observed using the process measure SASB.","[{'ForeName': 'Marte L', 'Initials': 'ML', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Gullestad Binder', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Hanne Sofie J', 'Initials': 'HSJ', 'LastName': 'Dahl', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Nikolai O', 'Initials': 'NO', 'LastName': 'Czajkowski', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Critchfield', 'Affiliation': 'Department of Graduate Psychology, James Madison University, Harrisonburg, VA 22807, USA.'}, {'ForeName': 'Per A', 'Initials': 'PA', 'LastName': 'Høglend', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17114105'] 2754,32526852,"Prebiotic Therapy with Inulin Associated with Low Protein Diet in Chronic Kidney Disease Patients: Evaluation of Nutritional, Cardiovascular and Psychocognitive Parameters.","A relationship between dysbiotic gut microbiome and chronic kidney disease (CKD) has been recently documented; it contributes to CKD-related complications, including cardiovascular disease. Aim: We tested how a low-protein diet (LPD)-with or without oral inulin supplementation as a prebiotic-modulates some inflammatory, atherosclerosis and endothelial dysfunction indices and nutritional markers, as well as psychocognitive functions in CKD patients. We conducted a prospective, case-control study on CKD patients on conservative therapy, divided in two groups: the intervention group treated with LPD (0.6 g/kg/day) plus inulin (19 g/day) and a control group treated with LPD without inulin, for six consecutive months. Clinical and hematochemical parameters as well as instrumental, and psychocognitive assessments (by SF-36 survey and MMSE, HAM-D, BDI-II) were recorded in all the participants at baseline (T0), at three months (T1) and at six months (T2). A total of 41 patients were enrolled: 18 in the intervention group and 23 in the control group. At T2, in both groups, we observed a significant reduction of serum nitrogen and phosphorus ( p ≤ 0.01) and serum uric acid ( p ≤ 0.03), and an improvement in metabolic acidosis (bicarbonates, p ≤ 0.01; base excess, p ≤ 0.02). Moreover, at T2 the intervention group showed a reduction in serum insulin ( p = 0.008) and fasting glucose levels ( p = 0.022), HOMA-IR ( p = 0.004), as well as lower total serum cholesterol ( p = 0.012), triglycerides ( p = 0.016), C-reactive protein ( p = 0.044) and homocysteine ( p = 0.044) and higher HDL ( p < 0.001) with respect to baseline. We also observed a significant amelioration of some quality of life and functional status indices (SF-36 survey) among the intervention group compared to controls, without a significant improvement in the cognitive state (MMSE). On the other hand, an amelioration in mood (by HAM-D and BDI-II) was found in the intervention group and in controls (only by BID-II). In conclusion, LPD in association with oral inulin supplementation improved glycemic and lipid metabolism and ameliorated the systemic inflammatory state, likely reducing cardiovascular risk in CKD patients and this may represent a promising therapeutic option, also improving quality of life and mood.",2020,"Moreover, at T2 the intervention group showed a reduction in serum insulin ( p = 0.008) and fasting glucose levels ( p = 0.022), HOMA-IR ( p = 0.004), as well as lower total serum cholesterol ( p = 0.012), triglycerides ( p = 0.016), C-reactive protein ( p = 0.044) and homocysteine ( p = 0.044) and higher HDL ( p < 0.001) with respect to baseline.","['Chronic Kidney Disease Patients', 'chronic kidney disease (CKD', 'CKD patients', '41 patients were enrolled: 18 in the intervention group and 23 in the control group']","['CKD', 'Prebiotic Therapy with Inulin Associated with Low Protein Diet', 'low-protein diet (LPD)-with or without oral inulin supplementation', 'LPD', 'oral inulin supplementation', 'control group treated with LPD without inulin']","['serum nitrogen and phosphorus', 'fasting glucose levels', 'total serum cholesterol', 'triglycerides', 'cardiovascular risk', 'HOMA-IR', 'quality of life and functional status indices (SF-36 survey', 'metabolic acidosis', 'instrumental, and psychocognitive assessments (by SF-36 survey and MMSE, HAM-D, BDI-II', 'cognitive state (MMSE', 'homocysteine', 'reduction in serum insulin', 'serum uric acid', 'C-reactive protein', 'quality of life and mood', 'glycemic and lipid metabolism']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451175', 'cui_str': 'Functional status index'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",41.0,0.0147668,"Moreover, at T2 the intervention group showed a reduction in serum insulin ( p = 0.008) and fasting glucose levels ( p = 0.022), HOMA-IR ( p = 0.004), as well as lower total serum cholesterol ( p = 0.012), triglycerides ( p = 0.016), C-reactive protein ( p = 0.044) and homocysteine ( p = 0.044) and higher HDL ( p < 0.001) with respect to baseline.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Mazzaferro', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Muscaritoli', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Mastroluca', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Testorio', 'Affiliation': 'Department of Obstetrical-Gynecological Sciences and Urologic Sciences, Unit of Nephrology, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Perrotta', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Esposito', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Campagna', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Di Grado', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Cesarina', 'Initials': 'C', 'LastName': 'Ramaccini', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'De Leo', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Galani', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, 25123 Brescia, Italy.'}, {'ForeName': 'Maria Ida', 'Initials': 'MI', 'LastName': 'Amabile', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Molfino', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy.'}]",Toxins,['10.3390/toxins12060381'] 2755,32526892,Immediate Effect of Balance Taping Using Kinesiology Tape on Dynamic and Static Balance after Ankle Muscle Fatigue.,"The objective of this study was to investigate whether ankle balance taping (ABT) applied after muscle fatigue-inducing exercise can cause immediate improvements in dynamic and static balance. A total of 31 adults (16 males and 15 females) met the inclusion criteria. The experiment was designed using a single-blinded, randomized controlled trial. Changes in static and dynamic balance were measured before and after inducing muscle fatigue in the ankles and after ABT or ankle placebo taping (APT). After ankle muscle fatigue-inducing exercise, both the ABT and APT groups showed significant increases in surface area ellipses in the static state with eyes open ( p < 0.05), and significant increases in surface area ellipses in the static and dynamic states with eyes closed (both p < 0.05). After taping of the fatigued ankle, surface area ellipses decreased significantly when eyes were open and closed in the static and dynamic states, but only in the ABT group ( p < 0.05). Static balance was significantly different between groups (eyes open, 36.2 ± 86; eyes closed, 22.9 ± 46.7). Dynamic balance was significantly different between groups (eyes open, 68.6 ± 152.1; eyes closed, 235.8 ± 317.6). ABT may help prevent ankle injuries in individuals who experience muscle fatigue around the ankles after sports and daily activities.",2020,"After ankle muscle fatigue-inducing exercise, both the ABT and APT groups showed significant increases in surface area ellipses in the static state with eyes open ( p < 0.05), and significant increases in surface area ellipses in the static and dynamic states with eyes closed (both p < 0.05).","['31 adults (16 males and 15 females) met the inclusion criteria', 'after Ankle Muscle Fatigue']","['Balance Taping Using Kinesiology Tape', 'ABT', 'ankle balance taping (ABT']","['surface area ellipses', 'Static balance', 'static and dynamic balance', 'Dynamic and Static Balance', 'Dynamic balance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",31.0,0.0281186,"After ankle muscle fatigue-inducing exercise, both the ABT and APT groups showed significant increases in surface area ellipses in the static state with eyes open ( p < 0.05), and significant increases in surface area ellipses in the static and dynamic states with eyes closed (both p < 0.05).","[{'ForeName': 'Hyun-Su', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': 'Department of Biomedical Health Science, Graduate School, Dong-Eui University, Busan 47340, Korea.'}, {'ForeName': 'Jung-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Nursing, Healthcare Sciences and Human Ecology, Dong-Eui University, Busan 47340, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020162'] 2756,32526916,Immediate Effects of Tibialis Anterior and Calf Muscle Taping on Center of Pressure Excursion in Chronic Stroke Patients: A Cross-Over Study.,"Stroke patients often have muscles spasticity, difficulty with posture control, and tend to fall. This study investigated the use of kinesiology tape for patients with spasticity of ankle muscles after stroke. This study had a randomized, repeated measures design, and evaluated the immediate effect of kinesiology tape on the center of pressure (COP) excursion when applied to the calf and tibialis anterior muscles in stroke survivors. We determined that the taping attachment direction affects the COP movement. Twenty subjects were randomly assigned to the tibialis anterior taping condition, calf taping condition, or nontaping condition. Condition excursion was assessed. The measured variables included the paretic side area, nonparetic side area, forward area, and backward area of COP. All evaluations were conducted immediately after taping. COP excursion for chronic stroke survivors improved after tibialis anterior and calf taping (p < 0.05). Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05). Kinesiology tape immediately increased the forward and backward COP excursion for patients with stroke.",2020,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","['Twenty subjects', 'patients with spasticity of ankle muscles after stroke', 'Chronic Stroke Patients', 'stroke survivors', 'patients with stroke']","['tibialis anterior taping condition, calf taping condition, or nontaping condition', 'Tibialis Anterior and Calf Muscle Taping', 'kinesiology tape']","['center of pressure (COP) excursion', 'COP excursion for chronic stroke survivors', 'forward and backward COP excursion', 'tibialis anterior taping conditions', 'Calf taping conditions', 'paretic side area, nonparetic side area, forward area, and backward area of COP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",20.0,0.0161572,"Calf taping conditions increased significantly in the forward area (p < 0.05), and tibialis anterior taping conditions increased significantly in the backward area (p < 0.05).","[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'NEULBOM Hospital 17, Poeun-daero 59 beon-gil, Suji-gu, Yongin-si, Gyeonggi-do 16864, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam 330-714, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17114109'] 2757,32526929,Pain Neuroscience Education for Children with Functional Abdominal Pain Disorders: A Randomized Comparative Pilot Study.,"This article explores the effectiveness of a newly developed Pain Neuroscience Education program for children (PNE4Kids) with functional abdominal pain disorder (FAPD). Children (6-12 years) with FAPD were randomly assigned to 1) the experimental group ( n = 14), participating in one hypnotherapy session (i.e., usual care) and one additional PNE4Kids session, or 2) the control group ( n = 14), participating in two hypnotherapy sessions. Parental pain catastrophizing, the child's functional disability (parental-proxy), pain-related fear (parent-proxy) and pain intensity, were assessed at baseline and one and three weeks after each therapy session. Pressure algometry and a conditioned pain modulation paradigm were performed at baseline and three weeks after completion of the last therapy session. Parents from both the experimental as well as the control group showed significantly less parental pain catastrophizing ( p < 0.01). Children showed significantly less functional disability ( p < 0.05), pain-related fear ( p < 0.01) and local pressure pain sensitivity ( p < 0.05) at short-term follow-up (three weeks after last intervention) in both groups. No significant ( p > 0.05) between-group differences were found. Hypnotherapy combined with PNE4Kids did not result in better clinical outcomes compared to hypnotherapy alone. Study limitations include the application of one single PNE4Kids session and the short follow-up time.",2020,Hypnotherapy combined with PNE4Kids did not result in better clinical outcomes compared to hypnotherapy alone.,"['children (PNE4Kids) with functional abdominal pain disorder (FAPD', 'Children (6-12 years) with FAPD', 'Children with Functional Abdominal Pain Disorders']","['Pain Neuroscience Education program', 'participating in one hypnotherapy session (i.e., usual care) and one additional PNE4Kids session, or 2) the control group', 'Pain Neuroscience Education', 'Hypnotherapy combined with PNE4Kids']","['parental pain catastrophizing', 'pain-related fear', 'local pressure pain sensitivity', ""Parental pain catastrophizing, the child's functional disability (parental-proxy), pain-related fear (parent-proxy) and pain intensity"", 'functional disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0325116,Hypnotherapy combined with PNE4Kids did not result in better clinical outcomes compared to hypnotherapy alone.,"[{'ForeName': 'Roselien', 'Initials': 'R', 'LastName': 'Pas', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rheel', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Van Oosterwijck', 'Affiliation': 'Pain in Motion International Research Group.'}, {'ForeName': 'Anthe', 'Initials': 'A', 'LastName': 'Foubert', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp (UA), D.S.022, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Robby', 'Initials': 'R', 'LastName': 'De Pauw', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Ghent University, Campus UZ, Corneel Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Leysen', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Roete', 'Affiliation': 'Antwerp University Hospital, department of Pediatrics, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Meeus', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ickmans', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9061797'] 2758,32527049,Impact of a Catch-Up Strategy of DT-IPV Vaccination during Hospitalization on Vaccination Coverage among People Over 65 Years of Age in France: The HOSPIVAC Study (Vaccination during Hospitalization).,"In France, diphtheria tetanus and inactivated polio vaccine (DT-IPV) coverage and immunization are insufficient in the elderly and decrease with age. The principal objective of this study was to assess the impact of a strategy of catch-up DT-IPV vaccination during hospitalization in people over the age of 65 years in central France (the Sarthe region). We performed a prospective, single-center, cluster-randomized study (four hospital wards). We included patients aged ≥65 years, without mental impairment, contraindication and who accepted to participate, hospitalized in the internal medicine wards in Le Mans Hospital from 28 May 2018 to 27 May 2019. The DT-IPV vaccination status of the patients was determined at inclusion and the wards were randomized (intervention and control). In the intervention group, vaccination was up-dated during hospitalization. In case of temporary contraindication, vaccination was prescribed at hospital discharge. Patients hospitalized in the control wards received oral information only. Final immunization status was determined by calling the patient's general practitioner two months after hospital discharge. One hundred and fifty seven patients were included: 73 in the intervention and 84 in the control arm. Baseline immunization coverage was 46.5%. Vaccination coverage increased from 56.2% to 80.8% in the intervention group and from 38.1% to 40.5% in the control group ( p < 0.001). Having received sufficient information from the general practitioner was the only factor associated with vaccination being up-to-date in uni- and multivariate analysis: OR = 5.07 [2.45-10.51]. In a setting of low vaccination coverage DT-IPV vaccination during hospitalization is an effective catch-up strategy.",2020,Vaccination coverage increased from 56.2% to 80.8% in the intervention group and from 38.1% to 40.5% in the control group ( p < 0.001).,"['people over the age of 65 years in central France (the Sarthe region', 'One hundred and fifty seven patients were included: 73 in the intervention and 84 in the control arm', 'People Over 65 Years of Age in France', 'patients aged ≥65 years, without mental impairment, contraindication and who accepted to participate, hospitalized in the internal medicine wards in Le Mans Hospital from 28 May 2018 to 27 May 2019']","['catch-up DT-IPV vaccination', 'DT-IPV Vaccination', 'diphtheria tetanus and inactivated polio vaccine (DT-IPV']","['Vaccination coverage', 'Baseline immunization coverage']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0278061', 'cui_str': 'Altered mental status'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0012546', 'cui_str': 'Diphtheria'}, {'cui': 'C0039614', 'cui_str': 'Tetanus'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4505149', 'cui_str': 'Immunization Coverage'}]",157.0,0.0446113,Vaccination coverage increased from 56.2% to 80.8% in the intervention group and from 38.1% to 40.5% in the control group ( p < 0.001).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Blanchi', 'Affiliation': 'Department of Infectious Diseases, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Vaux', 'Affiliation': 'Department of Infectious Diseases, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Toqué', 'Affiliation': 'Department of Internal Medecine, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Hery', 'Affiliation': 'Department of Internal Medecine, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Servane', 'Initials': 'S', 'LastName': 'Laforest', 'Affiliation': 'Department of Internal Medecine, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Giorgina Barbara', 'Initials': 'GB', 'LastName': 'Piccoli', 'Affiliation': 'Department of Nephrology, Le Mans Hospital, 72000 Le Mans, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Crochette', 'Affiliation': 'Department of Infectious Diseases, Le Mans Hospital, 72000 Le Mans, France.'}]",Vaccines,['10.3390/vaccines8020292'] 2759,32527120,Using medical comics to explore challenging everyday topics in medicine: lessons learned from teaching medical humanities.,"BACKGROUND Studying medicine requires an extensive acquisition of knowledge, skills and attitudes. At the MedUni Vienna, this wide range of skills is strengthened by discussing aspects of medical humanities (MH) with medical students in their pre-clinical fifth study year. Medical comics (MCs), as a part of MH, offer the possibility to address challenging situations within medical settings through the use of graphic illustrations. Thus, patient stories as well as different perspectives of patients, caregivers, and medical staff can be addressed. METHODS A total of 506 medical students were randomly assigned to one of three MCs within a blended learning setting via the Moodle online learning platform. The medical students were instructed to reflect on the MC by answering three questions within one week. Depending on the MC assigned, the learning objectives were to (I) comprehend demands on a young doctor during a night shift, (II) reflect on a patient examination situation, or (III) recognize patients' physical and/or emotional needs. The word counts of the answers and the time spent online answering the questions in the learning platform were analyzed. This was followed by an analysis in which the answers and their content were rated on a three-point Likert scale (insufficient, sufficient, exceptional). Subsequently, an MH and MCs lecture was held that incorporated the medical students' reflections. After the lecture, a one-minute paper (OMP) survey comprising two questions was conducted on the learning platform. RESULTS Of the 506 medical students assigned the online task, 505 completed it. On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task. Of all the answers, 84% were rated as sufficient or exceptional. Two OMP questions: (I) ""What was the most important thing you learned today?"", and (II) ""What questions remain unanswered?"" were answered by the medical students. ""What was the most important thing you learned today?"" was answered by 78% (n=393) of the medical students with a profound statement. When asked ""What questions remain unanswered?"", 85% (n=429) of the medical students stated that nothing was left unanswered. All the answers included 154 positive and 28 negative comments on the lecture. CONCLUSIONS The study results indicate that medical students saw great potential in the use of MCs in medical teaching in terms of addressing challenging topics and reflecting on them deeply. This kind of blended learning (a form of learning in which the advantages of face-to-face events and e-learning are combined) successfully showed that medical students can gain a deeper understanding of MH and be inspired through the use of MCs.",2020,"On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task.","['506 medical students assigned the online task', '506 medical students', '78% (n=393) of the medical students with a profound statement']","['blended learning', 'MCs within a blended learning setting via the Moodle online learning platform']",[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439808', 'cui_str': 'Profound'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4505477', 'cui_str': 'Online Education'}]",[],506.0,0.014258,"On average, each medical student wrote 110.87 words (SD: 78.54; range, 4.00-602.00) and spent 12.75 minutes (SD: 11.60) on the task.","[{'ForeName': 'Eva Katharina', 'Initials': 'EK', 'LastName': 'Masel', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria. eva.masel@gmx.at.'}, {'ForeName': 'Feroniki', 'Initials': 'F', 'LastName': 'Adamidis', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kitta', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gruebl', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Unseld', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Pavelka', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Herbert Hans', 'Initials': 'HH', 'LastName': 'Watzke', 'Affiliation': 'Department of Internal Medicine I, Division of Palliative Care, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zlabinger', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Praschinger', 'Affiliation': 'Teaching Center, Medical University of Vienna, Vienna, Austria.'}]",Annals of palliative medicine,['10.21037/apm-20-261'] 2760,32527152,Feasible Policy Evaluation by Design: A Randomized Synthetic Stepped-Wedge Trial of Mandated Disclosure in King County.,"Evidence-based policy is limited by the perception that randomized controlled trials (RCTs) are expensive and infeasible. We argue that carefully tailored research design can overcome these challenges and enable more widespread randomized evaluations of policy implementation. We demonstrate how a stepped-wedge (randomized rollout) design that adapts synthetic control methods overcame substantial practical, administrative, political, and statistical constraints to evaluating King County's new food safety rating system. The core RCT component of the evaluation came at little financial cost to the government, allowed the entire county to be treated, and resulted in no functional implementation delay. The case of restaurant sanitation grading has played a critical role in the scholarship on information disclosure, and our study provides the first evidence from a randomized trial of the causal effects of grading on health outcomes. We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.",2020,"We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.",['King County'],[],"['foodborne illness, hospitalization, or food handling practices', 'public engagement']","[{'cui': 'C0454792', 'cui_str': 'Offaly'}]",[],"[{'cui': 'C0016479', 'cui_str': 'Food poisoning'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0016469', 'cui_str': 'Food Handling'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.102428,"We find that the grading system had no appreciable effects on foodborne illness, hospitalization, or food handling practices but that the system may have marginally increased public engagement by encouraging higher reporting.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Handan-Nader', 'Affiliation': 'Department of Political Science, Stanford University, CA, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ho', 'Affiliation': 'Regulation, Evaluation and Governance Lab, Stanford University, CA, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Elias', 'Affiliation': 'Food Protection Program, Environmental Health Services, Public Health-Seattle & King County, Seattle, WA, USA.'}]",Evaluation review,['10.1177/0193841X20930852'] 2761,32527166,Effect of Family Empowerment on HbA1c Levels and Healing of Diabetic Foot Ulcers.,"Objective . To evaluate the effectiveness of family empowerment through educational interventions against HbA1c level and healing progress of diabetic foot ulcers. Method . A quasi-experimental design was employed involving 33 participants from 4 wound care clinics in Makassar, eastern Indonesia. The intervention group consisted of 17 participants and their families; the control group was composed of 16 participants who received nonstructural education. Family empowerment was measured by the Indonesian version of the Family Empowerment Scale instrument. Glycemic control was evaluated with HbA1c levels, and the wound healing process was evaluated on the Diabetic Foot Ulcers Assessment Scale. Result . After 3 months, Family Empowerment Scale scores improved, particularly in the subdomain of family knowledge (16.59 ± 3.92 vs 13.38 ± 1.26; P = .005) and attitude (3.65 ± 0.93 vs 2.75 ± 0.45; P = .002). After 3 months of intervention, HbA1c decreased (from 10.47 ± 2.44% to 8.81 ± 1.83%), compared with the control group ( P = .048). Meanwhile, an independent t test further revealed that the wound healing process tended to be better with the intervention group (4.71 ± 7.74) compared with the control group (17.25 ± 17.06), with P = .010 at the third month. Conclusion . Family-based education intervention creates family empowerment to control HbA1c levels and accelerate wound healing of diabetic foot ulcer.",2020,"After 3 months, Family Empowerment Scale scores improved, particularly in the subdomain of family knowledge (16.59 ± 3.92 vs 13.38 ± 1.26; P = .005) and attitude (3.65 ± 0.93 vs 2.75 ± 0.45; P = .002).","['33 participants from 4 wound care clinics in Makassar, eastern Indonesia']","['nonstructural education', 'family empowerment through educational interventions', 'Family Empowerment']","['Family empowerment', 'Family Empowerment Scale scores', 'wound healing process', 'Diabetic Foot Ulcers Assessment Scale', 'HbA1c Levels and Healing of Diabetic Foot Ulcers']","[{'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",33.0,0.0156628,"After 3 months, Family Empowerment Scale scores improved, particularly in the subdomain of family knowledge (16.59 ± 3.92 vs 13.38 ± 1.26; P = .005) and attitude (3.65 ± 0.93 vs 2.75 ± 0.45; P = .002).","[{'ForeName': 'Rasnah', 'Initials': 'R', 'LastName': 'Appil', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Elly Lilianty', 'Initials': 'EL', 'LastName': 'Sjattar', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Saldy', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Kasmawati', 'Initials': 'K', 'LastName': 'Kadir', 'Affiliation': 'Faculty of Nursing, Hasanuddin University, Makassar, Indonesia.'}]",The international journal of lower extremity wounds,['10.1177/1534734620930120'] 2762,32527167,"Impact of endometrioma surgery on ovarian reserve: a prospective, randomized, pilot study comparing stripping with CO 2 laser vaporization in patients with bilateral endometriomas.","OBJECTIVE To assess ovarian reserve through antral follicle count (AFC) and ovarian volume (OV) determination after decapsulation (stripping technique) or CO 2 laser vaporization in the surgical treatment of patients with bilateral ovarian endometriomas. METHODS This prospective, randomized, blinded, self-controlled pilot study was set in a tertiary university hospital between January 2017 and December 2017, and included consecutive patients with bilateral ovarian endometriomas ≥3 cm. The study was registered with ClinicalTrials.gov under the title 'Impact on ovarian reserve according to the type of ovarian endometrioma excision: laser versus conventional cystectomy'; NCT03826355. For each patient, the endometrioma on one side was randomly selected to undergo CO 2 laser vaporization and the contralateral endometrioma to undergo laparoscopic decapsulation. RESULTS A total of 16 patients were included. There were no statistically significant between-group differences in OV and AFC levels at baseline. At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. CONCLUSION Lower OV and AFC levels following excisional surgery for endometrioma versus CO 2 laser vaporization suggest a higher impact on ovarian reserve after the stripping procedure.",2020,"At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. ","['patients with bilateral endometriomas', 'A total of 16 patients were included', 'tertiary university hospital between January 2017 and December 2017, and included consecutive patients with bilateral ovarian endometriomas ≥3 cm', 'patients with bilateral ovarian endometriomas']","['endometrioma surgery', 'stripping with CO 2 laser vaporization', 'decapsulation (stripping technique) or CO 2 laser vaporization', 'ovarian endometrioma excision: laser versus conventional cystectomy', 'CO 2 laser vaporization and the contralateral endometrioma to undergo laparoscopic decapsulation']","['ovarian reserve through antral follicle count (AFC) and ovarian volume (OV) determination', 'OV and AFC levels', 'ovarian reserve', 'Lower OV and AFC levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",16.0,0.0433131,"At the 6-month follow-up, OV and AFC levels were significantly higher in the laser-treated group versus the stripping technique. ","[{'ForeName': 'Mariona', 'Initials': 'M', 'LastName': 'Rius', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Gracia', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ros', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'María-Ángeles', 'Initials': 'MÁ', 'LastName': 'Martínez-Zamora', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'deGuirior', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Quintas', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'Endometriosis Unit, ICGON, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.'}]",The Journal of international medical research,['10.1177/0300060520927627'] 2763,31885341,Gradual oculomotor training in blow-out orbital fracture reconstruction recovery.,"OBJECTIVE This study compared the impact of gradual oculomotor training (GOT) in blow-out orbital fracture (BOF) reconstruction recovery with the impact of high-intensity trainings. METHODS In total, 120 patients with BOF requiring orbital reconstruction surgery were randomly divided into four groups; all groups performed postoperative oculomotor training four times per day. Patients in Groups 1, 2, 3, and 4 performed 10, 20, 30, and 50 sets of all-direction movement per training on the first 3 days, respectively; they performed 10 additional sets per training on the following 4 days. Patients in all groups performed 50 sets per training from 8 days to 3 months postoperatively. Incision healing, pain, and satisfaction rate, as well as degree of diplopia, were recorded during follow-up. RESULTS At 7 days postoperatively, more patients in Group 1 had no/mild swelling and no/mild pain, compared with patients in Group 4. Patients in Groups 1 and 2 had higher satisfaction rates than patients in Group 4. The degree of diplopia did not significantly differ among the groups. CONCLUSIONS For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.",2019,"For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.",['120 patients with BOF requiring orbital reconstruction surgery'],"['postoperative oculomotor training', 'gradual oculomotor training (GOT', 'Gradual oculomotor training']","['wound healing, pain relief, and satisfaction; the degree of diplopia', 'Incision healing, pain, and satisfaction rate, as well as degree of diplopia', 'mild swelling and no/mild pain', 'satisfaction rates', 'degree of diplopia']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0029184', 'cui_str': 'Fracture of orbit'}, {'cui': 'C4761185', 'cui_str': 'Orbital reconstruction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",120.0,0.0273934,"For patients with BOF, GOT after reconstruction surgery was more beneficial for wound healing, pain relief, and satisfaction; the degree of diplopia did not significantly differ, compared with high-intensity trainings.","[{'ForeName': 'Changjuan', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Chengjing', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of international medical research,['10.1177/0300060519893846'] 2764,31885346,Effects of transcranial direct current stimulation of primary motor cortex on cortical sensory deficits and hand dexterity in a patient with stroke: A case study.,"Fine motor and manual dexterity deficits are the main causes of significant physical and psychosocial impairments in stroke survivors. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique used to modulate brain activity and improve clinical outcomes. This study was performed to investigate the efficacy of dual-hemispheric tDCS of the primary motor cortex (M1) in a patient with stroke exhibiting cortical sensation deficits. A double-blind, sham-controlled, single-case study was conducted. The patient underwent 30 sessions of sham tDCS followed by 30 real-stimulation sessions over both M1 cortices. Each session involved 20 minutes of 2-mA stimulation (current density, 0.08 mA/cm 2 ; total charge density, 0.096 C/cm 2 ). Functional measures were assessed using the Action Research Arm Test, grooved pegboard test, nine-hole peg test, and box and block test at several time points. Structural and diffusion tensor imaging data were acquired before (t 0 ) and after (t 1 ) stimulation. Slight improvements following sham tDCS were observed. However, following real stimulation, all results at all time points were clinically significant. Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills. tDCS intervention induced functional improvement and structural changes in this patient with stroke.",2019,Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills.,"['patient with stroke exhibiting cortical sensation deficits', 'stroke survivors', 'patient with stroke']","['dual-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'tDCS intervention']","['corticospinal tract and regional gray matter density', 'Action Research Arm Test, grooved pegboard test, nine-hole peg test, and box and block test at several time points', 'cortical sensory deficits and hand dexterity', 'functional improvement and structural changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.109766,Higher fractional anisotropy of the corticospinal tract and regional gray matter density were positively correlated with better recovery of fine motor skills.,"[{'ForeName': 'Turki S', 'Initials': 'TS', 'LastName': 'Abualait', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",The Journal of international medical research,['10.1177/0300060519894137'] 2765,31891274,Effects of clean intermittent self-catheterization on late bladder dysfunction after radical hysterectomy in cervical cancer.,"OBJECTIVE To identify the benefits of clean intermittent self-catheterization in women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer. METHODS Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited. A nursing intervention program focusing on clean intermittent self-catheterization and a drinking plan was implemented. We recorded urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments for patients with cervical cancer . RESULTS All patients were able to satisfactorily manage clean intermittent self-catheterization following video-based operational training. Bladder function was significantly increased after 3-month intervention compared with before the intervention. Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention. The rate of a positive catheter specimen of urine test significantly decreased over time. There was significant improvement in quality of life in five dimensions between weeks 1 and 12 following the intervention. CONCLUSIONS Patients are able to learn the technique of clean intermittent self-catheterization without any difficulty. This technique is effective together with a drinking plan to decrease late bladder dysfunction caused by radical hysterectomy in cervical cancer.",2019,"Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention.","['patients with cervical cancer ', 'women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer', 'Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited', 'late bladder dysfunction after radical hysterectomy in cervical cancer']",['clean intermittent self-catheterization'],"['quality of life', 'late bladder dysfunction', 'urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments', 'Bladder function', 'rate of a positive catheter specimen of urine test', 'Urinary times', 'post-voiding residual urine volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0473154', 'cui_str': 'Clean intermittent self-catheterization'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232841', 'cui_str': 'Bladder dysfunction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}]",30.0,0.0136846,"Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chun-Lan', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wan-Ying', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Guan-Mian', 'Initials': 'GM', 'LastName': 'Liang', 'Affiliation': 'Department of Head and Neck Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Li-Yao', 'Initials': 'LY', 'LastName': 'Xia', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}]",The Journal of international medical research,['10.1177/0300060519885546'] 2766,31918612,Comparing Relaxation Versus Mastery Microbreak Activity: A Within-Task Recovery Perspective.,"Recovery from work is generally thought to occur outside of the workplace. However, employees may also have the opportunity to recover within the work day via microbreaks during demanding work tasks. Two major strategies for mitigating fatigue include psychological detachment (i.e., mentally disengaging) and replenishing motivational incentives via positive affect. This study examined whether 40-s ""microbreaks"" improve work recovery and to what extent different microbreak content (mastery vs. relaxation activities) boost performance. Using an experimental study, we randomly assigned individuals to receive a relaxation microbreak ( n  =   59), a mastery microbreak ( n  =   68), or no break ( n  =   72) in the middle of a monotonous work task and assessed work performance. Microbreaks improved task performance and within-task recovery, but only for psychological detachment (not positive affect). Mastery breaks also resulted in more psychological detachment than relaxation breaks, but this increased detachment did not explain performance differences between break types. These results build on existing recovery theories by further demonstrating within-task recovery and provide practical implications for organizations to consider the importance of microbreaks.",2020,"Mastery breaks also resulted in more psychological detachment than relaxation breaks, but this increased detachment did not explain performance differences between break types.",[],"['relaxation microbreak', 'mastery microbreak ( n\u2009 = \u2009 68), or no break ( n\u2009 = \u2009 72) in the middle of a monotonous work task and assessed work performance', 'Relaxation Versus Mastery Microbreak Activity']","['psychological detachment', 'task performance and within-task recovery']",[],"[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.037832,"Mastery breaks also resulted in more psychological detachment than relaxation breaks, but this increased detachment did not explain performance differences between break types.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': ''}, {'ForeName': 'Xinyu Judy', 'Initials': 'XJ', 'LastName': 'Hu', 'Affiliation': 'Department of Psychology, Northern Illinois University, DeKalb, IL, USA.'}, {'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Barber', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}]",Psychological reports,['10.1177/0033294119900347'] 2767,30964365,Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting β 2 -agonists in South Korea.,"Objectives: We aimed to assess the cost-utility of reslizumab for patients with severe eosinophilic asthma uncontrolled with high-dose inhaled corticosteroids and long-acting β 2 -agonists (ICS/LABAs) in Korea. Methods: A Markov model with limited societal perspective was used to compare the costs and quality-adjusted life years (QALYs) of reslizumab add-on therapy with standard-of-care (high-dose ICS/LABA) and standard-of-care alone. The model adopted a 4 week cycle with the following six health states over a lifetime (60 years): controlled asthma, uncontrolled asthma, moderate exacerbation, severe exacerbation, all-cause death and asthma-related death. The population comprised adult patients (age ≥18 years) with severe eosinophilic asthma (eosinophils ≥400 cells/μL) at Global Initiative for Asthma (GINA) step 4 or 5 who had experienced at least three exacerbations in the preceding year. Model inputs were sourced from individual patient-level data from two 52 week randomized controlled trials of reslizumab (NCT01287039, NCT01285323). The model included discontinuation rules where patients uncontrolled with reslizumab add-on therapy were transitioned to the standard-of-care arm. Costs and QALYs were annually discounted at 5%. Deterministic and probabilistic sensitivity analyses were performed. Results: Reslizumab add-on therapy was associated with increased cost (US$119,394) and improved QALYs (5.17) compared with standard-of-care alone, resulting in an incremental cost-effectiveness ratio of US$23,081 per QALY gained. Body weight, time horizon and discount rate were influential factors in the model. Conclusions: The addition of reslizumab to high-dose ICS/LABA was cost-effective in Korean patients with severe eosinophilic asthma uncontrolled with high-dose ICS/LABA, based on the threshold of 1 gross domestic product in Korea. Trial registration: ClinicalTrials.gov identifier: NCT01285323. Trial registration: ClinicalTrials.gov identifier: NCT01287039.",2019,"Results: Reslizumab add-on therapy was associated with increased cost (US$119,394) and improved QALYs (5.17) compared with standard-of-care alone, resulting in an incremental cost-effectiveness ratio of US$23,081 per QALY gained.","['Korean patients with severe eosinophilic asthma uncontrolled with high-dose ICS/LABA', 'South Korea', 'adult patients (age ≥18\u2009years) with severe eosinophilic asthma (eosinophils ≥400 cells/μL) at Global Initiative for Asthma (GINA) step 4 or 5 who had experienced at least three exacerbations in the preceding year', 'patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and', 'patients with severe eosinophilic asthma uncontrolled with high-dose inhaled corticosteroids and long-acting β 2 -agonists (ICS/LABAs) in Korea']","['reslizumab to high-dose ICS/LABA', 'reslizumab add-on therapy with standard-of-care (high-dose ICS/LABA) and standard-of-care alone', 'reslizumab']","['Costs and QALYs', 'increased cost (US$119,394) and improved QALYs', 'Body weight, time horizon and discount rate']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.191863,"Results: Reslizumab add-on therapy was associated with increased cost (US$119,394) and improved QALYs (5.17) compared with standard-of-care alone, resulting in an incremental cost-effectiveness ratio of US$23,081 per QALY gained.","[{'ForeName': 'Sola', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'College of Pharmacy, Pusan National University, Busan, Republic of Korea.'}, {'ForeName': 'Siin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'College of Pharmacy, Pusan National University, Busan, Republic of Korea.'}, {'ForeName': 'Hyungtae', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'College of Pharmacy, Pusan National University, Busan, Republic of Korea.'}, {'ForeName': 'Hae Sun', 'Initials': 'HS', 'LastName': 'Suh', 'Affiliation': 'College of Pharmacy, Pusan National University, Busan, Republic of Korea.'}]",Current medical research and opinion,['10.1080/03007995.2019.1605159'] 2768,30989638,Framing plagiarism as a disease heightens students' valuation of academic integrity.,"Prior research based on conceptual metaphor theory has explored how metaphorical language subtly influences how people perceive social issues. For instance, rhetoric comparing a perceived problem to a disease has been used historically to generate support for a wide array of measures proposed to ""treat"" the problem, and recent experimental work demonstrates the efficacy of this approach. The current paper extends this literature by looking at the use of disease metaphor in a novel domain: student perceptions of plagiarism on campus. We found that participants (N = 365) exposed to a disease-metaphoric description of plagiarism on campus perceived it to be a more severe problem and, as a result, were more supportive of a variety of anti-plagiarism policies. This mediational analysis further demonstrates the far-reaching practical significance of metaphor.",2020,The current paper extends this literature by looking at the use of disease metaphor in a novel domain: student perceptions of plagiarism on campus.,['participants (N\u2009=\u2009365'],[],[],[],[],[],,0.017737,The current paper extends this literature by looking at the use of disease metaphor in a novel domain: student perceptions of plagiarism on campus.,"[{'ForeName': 'Lucas A', 'Initials': 'LA', 'LastName': 'Keefer', 'Affiliation': 'Department of Psychology, University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'Zachary K', 'Initials': 'ZK', 'LastName': 'Rothschild', 'Affiliation': 'Department of Psychology, Bowdoin College, Brunswick, ME, USA.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12581'] 2769,31221047,"Telecare management of pain and mood symptoms: Adherence, utility, and patient satisfaction.","INTRODUCTION Pain, depression, and anxiety are prominent symptoms that frequently co-occur, causing significant debilitation and frequent primary care visits. This paper examines the acceptability of telecare and self-management modules in managing these conditions in a randomized trial. METHODS The Comprehensive Management of Mood and Physical Symptoms (CAMMPS) trial compared an automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention that added telecare facilitation of enhanced services. Data from the CAMMPS trial were analysed to compare the acceptability of these two interventions as indicated by utilization and patient satisfaction surveys. RESULTS The mean number of automated reports completed was similar between the CSM and ASM groups (14.5 vs 14.0). Responses designated with clinically relevant ""red alerts"" (i.e. patient reports warranting an expedited nurse contact) were more frequent in the CSM group (10.2 vs 8.3). The CSM and ASM groups completed a similar number of the nine self-management modules (6.3 vs 5.8). The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p  = .003). The most common feedback suggestion from the ASM group was to have more personal interaction, while participants from both groups commonly suggested technical improvements or requests for more flexible timing of calls. DISCUSSION Participants generally found both interventions satisfactory, with a trend in satisfaction data suggesting that patients tended to find the CSM intervention more helpful.",2019,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p  = .003).,[],"['automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention', 'CSM intervention', 'ASM']","['mean number of automated reports completed', 'mean helpfulness score']",[],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0507187,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p  = .003).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bushey', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Fitsum', 'Initials': 'F', 'LastName': 'Baye', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Lourens', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Weitlauf', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856156'] 2770,31431133,Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy.,"OBJECTIVE This pilot study was designed to determine the feasibility, tolerability, safety, and efficacy of group teletherapy for persons with chronic pain. The aim was to present preliminary outcomes of an open trial of group cognitive behavioural therapy (CBT) teletherapy compared with an in-person chronic pain patient group. METHODS We recruited 47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured, CBT-oriented pain management group using WebEx and compared them with 46 subjects who participated in a parallel, content-matched, in-person, weekly group. Both groups included goal setting, skills training, relaxation exercises, group discussion, and practice assignments. All subjects completed baseline measures, which were repeated post-treatment. Those in the online group participated in weekly telephone interviews and rated the perceived helpfulness of the remote group. RESULTS The average age of the online group participants was 54.5 ( ± 14.3) years and 70.2% were female, compared with 59.7 ( ± 13.0) years of age and 57.8% females among the in-person group members. On follow-up, both CBT groups showed modest improvements on the outcome measures. Results of this preliminary investigation comparing online teletherapy with in-person CBT suggest similar benefit. Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10). DISCUSSION Preliminary findings suggest that online group CBT may be as effective in improving coping among persons with chronic pain as in-person groups. More rigorous controlled trials are needed to adequately assess the outcome benefit of online teletherapy for chronic pain.",2019,"Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10). ","['47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured', 'years and 70.2% were female, compared with 59.7 (\u2009±\u200913.0) years of age and 57.8% females among the in-person group members', 'persons with chronic pain', 'chronic pain', 'person chronic pain patient group', '46 subjects who participated in a parallel, content-matched, in-person, weekly group']","['teletherapy', 'online teletherapy', 'Online group pain management', 'CBT-oriented pain management group using WebEx', 'group cognitive behavioural therapy (CBT) teletherapy', 'group teletherapy']","['feasibility, tolerability, safety, and efficacy']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",47.0,0.0491916,"Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10). ","[{'ForeName': 'Timothy Y', 'Initials': 'TY', 'LastName': 'Mariano', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Asimina', 'Initials': 'A', 'LastName': 'Lazaridou', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Edgar L', 'Initials': 'EL', 'LastName': 'Ross', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Jamison', 'Affiliation': ""Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}]",Journal of telemedicine and telecare,['10.1177/1357633X19870369'] 2771,31570034,Evaluation of telemonitoring of continuous positive airway pressure therapy in obstructive sleep apnoea syndrome: TELEPAP pilot study.,"INTRODUCTION Continuous positive airway pressure is an effective treatment for obstructive sleep apnoea syndrome. However, positive airway pressure compliance rates are disappointingly low, so effective interventions are needed to improve compliance in sleep apnoea. Telemonitoring has been used to improve compliance, but results have been inconsistent. This study aimed to determine outcomes of telemonitoring positive airway pressure compliance and efficacy data compared to usual care and phone-call care. METHODS Randomized controlled study in which 51 patients (82.4% male; between 25 and 78 years), diagnosed with moderate to severe obstructive sleep apnoea were consecutively randomized to usual care, weekly phone-call care or telemonitored care with the use of Restraxx™. All patients were submitted to a comprehensive educational programme during positive airway pressure adaptation. Patients were followed for the first four weeks of treatment with automatic positive airway pressure (AutoSet Spirit S8®; ResMed), and compliance and efficacy data were analyzed. RESULTS Telemonitored care group used automatic positive airway pressure an average of 5.0 ± 1.8 hours/night, usual care patients 5.1 ± 2.5 hours and phone-call care patients 3.9 ± 2.6 hours. The residual Apnoea--Hypopnoea Index was 5.3 ± 3.0 in telemonitored care, 5.0 ± 2.5 in usual care and 5.6 ± 3.8 in phone-call care. No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and p  = 0.825, respectively). DISCUSSION In the presence of a comprehensive educational programme during positive airway pressure adaptation, telemonitoring patients did not show benefits concerning compliance and efficacy. A larger follow-up period is needed to evaluate the long-term results of a telemonitoring programme.",2019,"No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and p  = 0.825, respectively). ","['obstructive sleep apnoea syndrome', '51 patients (82.4% male; between 25 and 78 years), diagnosed with moderate to severe obstructive sleep apnoea']","['usual care, weekly phone-call care or telemonitored care with the use of Restraxx™', 'usual care and phone-call care', 'comprehensive educational programme', 'Continuous positive airway pressure', 'telemonitoring of continuous positive airway pressure therapy']","['automatic positive airway pressure', 'positive airway pressure compliance or efficacy', 'residual Apnoea--Hypopnoea Index']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4761101', 'cui_str': 'Automatic positive airway pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0223554,"No statistically significant differences were found between groups regarding positive airway pressure compliance or efficacy ( p  = 0.296 and p  = 0.825, respectively). ","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernandes', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Antunes', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martinho', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Abreu', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pinto', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bárbara', 'Affiliation': 'Sleep and Non-Invasive Ventilation Unit, Thorax Department, Centro Hospitalar Universitário Lisboa Norte, Portugal.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19875850'] 2772,31613134,Effects of parenting adults with disabilities on later-life health: The role of intergenerational ambivalence.,"According to family systems theory, strains from parenting an adult with disabilities may spill over to parents' relationships with their other children and disrupt family dynamics and their well-being in later-life. This study examined whether parental ambivalence toward their nondisabled children is greater in families of adults with disabilities (developmental disabilities [DD] or serious mental illnesses [SMI]) than families without any adult children with disabilities. The study also investigated whether ambivalence mediates the associations between having an adult child with DD or SMI and parents' health. Data were from the 2011 Wisconsin Longitudinal Study in which aging parents (M age = 71; n = 6,084) were asked about their relationship with each of their adult children. Multilevel regression models and multilevel structural equation models were estimated to analyze the data. Our findings showed that parents of an adult with SMI felt greater ambivalence toward their nondisabled adult children than comparison group parents of adult children without disabilities, whereas no significant differences were found between parents of an adult child with DD and comparison group parents. Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health. The findings have implications for clinical practice with aging families of adults with disabilities and suggest the need for additional research to better understand intergenerational parent-adult child dynamics in these families. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health.,"['2011 Wisconsin Longitudinal Study in which aging parents (M age = 71; n = 6,084', 'parenting adults with disabilities on later-life health', 'adult children with disabilities', ""adult child with DD or SMI and parents' health"", 'adults with disabilities', 'families of adults with disabilities (developmental disabilities [DD']",[],[],"[{'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0524331', 'cui_str': 'Elderly parents'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}]",[],[],6084.0,0.027497,Parental ambivalence toward their nondisabled adult children played a significant indirect role in the negative association between having a child with SMI and parental physical and mental health.,"[{'ForeName': 'Eun Ha', 'Initials': 'EH', 'LastName': 'Namkung', 'Affiliation': 'Lurie Institute for Disability Policy.'}, {'ForeName': 'Jan S', 'Initials': 'JS', 'LastName': 'Greenberg', 'Affiliation': 'School of Social Work, University of Wisconsin- Madison.'}, {'ForeName': 'Marsha R', 'Initials': 'MR', 'LastName': 'Mailick', 'Affiliation': 'Waisman Center, University of Wisconsin- Madison.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Floyd', 'Affiliation': 'Department of Psychology, University of Hawaii at Manoa.'}]",Psychology and aging,['10.1037/pag0000413'] 2773,31948365,Psychophysiological Effects of Different Methods of Inducing Restoration Needs.,"The purpose of this study was to examine the psychophysiological effects of different restoration need-inducing methods and the changes in these effects overtime. This study adopted a randomized controlled trial to assign participants (experiment 1: n  = 120, experiment 2: n  = 90) to four experimental treatments: control, imagined fatigue, the Stroop task and the binary classification task, and the Markus and Peters arithmetic test. We used self-report scales (The Pleasure-Arousal-Dominance emotion scale, The Well-being Measures, and The Restoration Scale) and an attention test (backward digit span) as pre- and posttests, and a physiological measuring device to continually assess participants' bodily mobilizations. The results showed that the Stroop task and the binary classification task as well as the Markus and Peters arithmetic test more significantly increased the arousal of subjective perception and decreased restoration than the control and imagined fatigue, and the physiological influences of the methods varied overtime with no definitive trend.",2020,"The results showed that the Stroop task and the binary classification task as well as the Markus and Peters arithmetic test more significantly increased the arousal of subjective perception and decreased restoration than the control and imagined fatigue, and the physiological influences of the methods varied overtime with no definitive trend.","['participants (experiment 1: n \u2009=\u2009120, experiment 2']","['n \u2009=\u200990) to four experimental treatments: control, imagined fatigue, the Stroop task and the binary classification task, and the Markus and Peters arithmetic test']","['arousal of subjective perception', 'Pleasure-Arousal-Dominance emotion scale']","[{'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.027818,"The results showed that the Stroop task and the binary classification task as well as the Markus and Peters arithmetic test more significantly increased the arousal of subjective perception and decreased restoration than the control and imagined fatigue, and the physiological influences of the methods varied overtime with no definitive trend.","[{'ForeName': 'Ke-Tsung', 'Initials': 'KT', 'LastName': 'Han', 'Affiliation': 'Department of Landscape Architecture, National Chin-Yi University of Technology, Taichung.'}]",Psychological reports,['10.1177/0033294119898121'] 2774,31969067,Effects of Self-Affirmation Feedback on Exercise Intention of Women in Their Twenties Depending on Construal Level.,"This study examines how type of instructor feedback influences cognitive processes conducive to participants' health behavior, using a new theoretical approach based on self-affirmation and construal level theory. In Study 1, feasibility self-affirmed feedback (FSF) and desirability self-affirmed feedback (DSF) were qualitatively explored with Vinyasa Yoga instructors, and four FSF and DSF feedback scenarios were developed. In Study 2, 55 (FSF group: 28 and DSF group: 27) women in their twenties participating in a Vinyasa Yoga program were randomly assigned to two experimental self-affirmation feedback groups (FSF and DSF) and exposed to FSF and DSF, respectively, for four weeks based on the scenarios developed in Study 1. The analysis of changes in exercise intention triggered by the participants' exposure to self-affirmation feedback showed that participants exposed to DSF experienced a more positive influence than those exposed to FSF in their continuation intentions of success.",2020,The analysis of changes in exercise intention triggered by the participants' exposure to self-affirmation feedback showed that participants exposed to DSF experienced a more positive influence than those exposed to FSF in their continuation intentions of success.,"['Women in Their Twenties Depending on Construal Level', ""participants' health behavior"", '55 (FSF group: 28 and DSF group: 27) women in their twenties participating in a Vinyasa Yoga program']","['feasibility self-affirmed feedback (FSF) and desirability self-affirmed feedback (DSF', 'Self-Affirmation Feedback', 'FSF', 'experimental self-affirmation feedback groups (FSF and DSF) and exposed to FSF and DSF']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037408', 'cui_str': 'Social Desirability'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],,0.0231799,The analysis of changes in exercise intention triggered by the participants' exposure to self-affirmation feedback showed that participants exposed to DSF experienced a more positive influence than those exposed to FSF in their continuation intentions of success.,"[{'ForeName': 'Myoungjin', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Research Institute for Basic Sciences, Soonchunhyang University, Asansi, South Korea.'}, {'ForeName': 'Miyoung', 'Initials': 'M', 'LastName': 'Roh', 'Affiliation': ""Ewha Woman's University, Seoul, South Korea.""}, {'ForeName': 'Minkwon', 'Initials': 'M', 'LastName': 'Moon', 'Affiliation': 'Seoul National University, Seoul, South Korea.'}]",Psychological reports,['10.1177/0033294119899895'] 2775,32151227,Dietary nitrate supplementation effect on dynamic cerebral autoregulation in normoxia and acute hypoxia.,"We tested the hypothesis that increasing the nitric oxide (NO) bioavailability by dietary nitrate would recover the hypoxia-induced reduction in dynamic cerebral autoregulation (CA). Twelve healthy males (age 21 ± 2 years) completed four days of dietary supplementation with a placebo or inorganic nitrate drink (140-ml beetroot juice per day) followed by 60-min of normoxia or hypoxia (fraction of inspired oxygen [FiO 2 ] = 13%). Duplex ultrasonography was used to perform volumetric change-based assessment of dynamic CA in the internal carotid artery (ICA). Dynamic CA was assessed by rate of regulation (RoR) of vascular conductance using the thigh-cuff method. Four days of beetroot supplementation increased circulating nitrate by 208 [171,245] μM (mean difference [95% confidence interval]) compared with placebo. Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]). Compared with placebo, nitrate did not alter dynamic CA in normoxia (RoR Δ-0.022 [-0.060, 0.016]) or hypoxia (RoR Δ0.017 [-0.019, 0.053]). Further, nitrate did not affect ICA vessel diameter, blood velocity or flow in either normoxia or hypoxia. Increased bioavailability of NO through dietary nitrate supplementation did not recover the hypoxia-induced reduction in dynamic CA. This suggests the mechanism of hypoxia-induced reduction in dynamic CA does not relate to the availability of NO.",2020,"Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]).","['Twelve healthy males (age 21\u2009±\u20092\u2009years', 'normoxia and acute hypoxia']","['dietary supplementation with a placebo or inorganic nitrate drink (140-ml beetroot juice per day) followed by 60-min of normoxia or hypoxia (fraction of inspired oxygen [FiO 2 ]\u2009=\u200913', 'Duplex ultrasonography', 'placebo', 'Dietary nitrate supplementation']","['dynamic CA in normoxia', 'Dynamic CA', 'rate of regulation (RoR) of vascular conductance', 'ICA vessel diameter, blood velocity or flow', 'dynamic cerebral autoregulation', 'circulating nitrate']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]",12.0,0.0383355,"Dynamic CA was lower in hypoxia than normoxia (RoR Δ-0.085 [-0.116, -0.054]).","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'Division of Human Environmental Science, Mt. Fuji Research Institute, Fujiyoshida, Japan.'}, {'ForeName': 'Gabriella Mk', 'Initials': 'GM', 'LastName': 'Rossetti', 'Affiliation': 'Extremes Research Group, College of Human Sciences, Bangor University, Bangor, Wales.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Oliver', 'Affiliation': 'Extremes Research Group, College of Human Sciences, Bangor University, Bangor, Wales.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X20910053'] 2776,32216457,Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients.,"OBJECTIVES The authors have previously tried to develop a model for the testing of novel drug candidates for migraine, using the headache and migraine provoking agent cilostazol. Previous studies have used sumatriptan tablets as the validating drug, but they were not sufficiently effective. In this study we test the effect of subcutaneous sumatriptan on cilostazol induced headache in patients with migraine without aura. METHOD Thirty patients with migraine without aura received 200 mg cilostazol on two different study days. The induced headache was treated with subcutaneous sumatriptan in a randomized, double-blind cross-over design. The patients filled out a self-reported headache questionnaire until 12 h after cilostazol. RESULTS All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the placebo day. Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003). The difference between headache intensity on the sumatriptan day and the placebo day was significant at both 2 h ( p  = 0.01) and 4 h ( p  = 0.0007) after treatment. CONCLUSION Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. The cilostazol model may be useful as a tool to test the potential of new anti-migraine drugs. Trial registration: The study is registered on clinicaltrials.gov (NCT03422796).",2020,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"['Thirty patients with migraine without aura received 200 mg cilostazol on two different study days', 'All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the', 'patients with migraine without aura', 'migraine patients']","['Subcutaneous sumatriptan', 'subcutaneous sumatriptan', 'Sumatriptan', 'placebo']","['headache questionnaire', 'cilostazol induced headache', 'headache intensity', 'headache score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0650812,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Helene Rønde', 'Initials': 'HR', 'LastName': 'Bjerg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420915166'] 2777,30665602,Sequential and simultaneous treatment approaches to cannabis use disorder and tobacco use.,"Tobacco smoking among those seeking treatment for cannabis use disorder (CUD) is common and is a negative predictor of cannabis outcomes. Quitting tobacco may be beneficial for those seeking to quit cannabis use. This initial proof of concept, controlled trial was designed to compare a simultaneous versus sequential tobacco intervention among those seeking treatment for CUD. Sixty-seven adults received either a simultaneous (SIM) or sequential (SEQ) approach to tobacco cessation in the context of outpatient treatment for CUD. A tobacco intervention (TI) that combined web-based counseling with nicotine replacement therapy (NRT) was provided during weeks 1-12 for SIM and was delayed until weeks 13-24 for SEQ. During weeks 1-12, no between-condition significant differences were observed on treatment participation or cannabis use outcomes. The majority of SIM participants initiated TI counseling (62%), 50% made at least one quit attempt and 41% initiated NRT. Interestingly, 39% in SEQ made tobacco quit attempts and 18% initiated NRT on their own before the TI was offered to them. However, only 30% of those in SEQ continued treatment during weeks 13-24, which compromised between-condition comparisons following the TI, but illustrated a potential clinical concern with delaying the TI. Tobacco cessation outcomes generally were poor and did not differ between conditions. This initial controlled trial suggests that addressing tobacco use during CUD treatment is acceptable and generates action towards tobacco cessation. Additional trials testing more intensive TI models may be necessary to identify more efficacious interventions for co-use of cannabis and tobacco.",2019,"During weeks 1-12, no between-condition significant differences were observed on treatment participation or cannabis use outcomes.",['Sixty-seven adults'],"['sequential tobacco intervention', 'simultaneous (SIM) or sequential (SEQ) approach to tobacco cessation', 'tobacco intervention (TI) that combined web-based counseling with nicotine replacement therapy (NRT']","['Tobacco smoking', 'Tobacco cessation outcomes', 'treatment participation or cannabis use outcomes']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]",67.0,0.0534283,"During weeks 1-12, no between-condition significant differences were observed on treatment participation or cannabis use outcomes.","[{'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, United States of America.'}, {'ForeName': 'Denise D', 'Initials': 'DD', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, University of Washington, United States of America.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Departments of Psychiatry and Psychological Science, University of Vermont, United States of America.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Brunette', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanger', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, United States of America.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Etter', 'Affiliation': 'Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Auty', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, United States of America.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Budney', 'Affiliation': 'Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, United States of America. Electronic address: Alan.j.budney@dartmouth.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2018.12.005'] 2778,32528330,"Effects of Yoga Respiratory Practice ( Bhastrika pranayama ) on Anxiety, Affect, and Brain Functional Connectivity and Activity: A Randomized Controlled Trial.","Pranayama refers to a set of yoga breathing exercises. Recent evidence suggests that the practice of pranayama has positive effects on measures of clinical stress and anxiety. This study explored the impact of a Bhastrika pranayama training program on emotion processing, anxiety, and affect. We used a randomized controlled trial design with thirty healthy young adults assessed at baseline and after 4 weeks of pranayama practices. Two functional magnetic resonance imaging (MRI) protocols were used both at baseline and post-intervention: an emotion task as well as a resting-state acquisition. Our results suggest that pranayama significantly decreased states of anxiety and negative affect. The practice of pranayama also modulated the activity of brain regions involved in emotional processing, particularly the amygdala, anterior cingulate, anterior insula, and prefrontal cortex. Resting-state functional MRI (fMRI) showed significantly reduced functional connectivity involving the anterior insula and lateral portions of the prefrontal cortex. Correlation analysis revealed that changes in connectivity between the ventrolateral prefrontal cortex and the right anterior insula were associated with changes in anxiety. Although it should be noted that these analyses were preliminary and exploratory, it provides the first evidence that 4 weeks of B. pranayama significantly reduce the levels of anxiety and negative affect, and that these changes are associated with the modulation of activity and connectivity in brain areas involved in emotion processing, attention, and awareness. The study was registered at https://www.ensaiosclinicos.gov.br/rg/RBR-2gv5c2/(RBR-2gv5c2).",2020,"The practice of pranayama also modulated the activity of brain regions involved in emotional processing, particularly the amygdala, anterior cingulate, anterior insula, and prefrontal cortex.",['thirty healthy young adults assessed at baseline and after 4 weeks of pranayama practices'],"['Two functional magnetic resonance imaging (MRI) protocols', 'Bhastrika pranayama training program', 'yoga breathing exercises', 'Yoga Respiratory Practice ( Bhastrika pranayama ', 'Resting-state functional MRI (fMRI']","['emotion processing, anxiety, and affect', 'states of anxiety', 'anxiety', 'Anxiety, Affect, and Brain Functional Connectivity and Activity', 'functional connectivity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",30.0,0.0260594,"The practice of pranayama also modulated the activity of brain regions involved in emotional processing, particularly the amygdala, anterior cingulate, anterior insula, and prefrontal cortex.","[{'ForeName': 'Morgana M', 'Initials': 'MM', 'LastName': 'Novaes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Palhano-Fontes', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}, {'ForeName': 'Heloisa', 'Initials': 'H', 'LastName': 'Onias', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}, {'ForeName': 'Katia C', 'Initials': 'KC', 'LastName': 'Andrade', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lobão-Soares', 'Affiliation': 'Department of Biophysics and Pharmacology, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Arruda-Sanchez', 'Affiliation': 'Department of Radiology, Medical School, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Elisa H', 'Initials': 'EH', 'LastName': 'Kozasa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Danilo F', 'Initials': 'DF', 'LastName': 'Santaella', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Draulio Barros', 'Initials': 'DB', 'LastName': 'de Araujo', 'Affiliation': 'Brain Institute, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00467'] 2779,32528333,"Regular Physical Activity, Short-Term Exercise, Mental Health, and Well-Being Among University Students: The Results of an Online and a Laboratory Study.","The health benefits of regular physical activity and aerobic exercise are undisputed in the literature. The present series of pilot studies had two major objectives: (a) examine mental health, well-being, and regular physical activity of university students and (b) explore the potential health benefits of short-term aerobic exercise on university students in an online and a laboratory study. Mental health and well-being were measured before (Time 1, T1) and after (Time 2, T2) a 6 week (online study) and 2 week (laboratory study) low- to moderate-intensity aerobic exercise intervention. Mental health and well-being were assessed using standardized self-report measures of depression, anxiety, positive and negative affect, perceived stress and coping strategies, body dissatisfaction, and quality of life. The effects of the aerobic exercise were compared to a cognitive non-exercise control condition (online study), motor coordination exercise (laboratory study), and a waiting list (online and laboratory). A total of 185 university students were recruited from German universities at T1. Further, 74 (women: n = 67) students completed the 6-week intervention. Similarly, 32 (women: n = 30) participants completed the 2 week intervention (laboratory study). At T1, 36.6% of the students (women and men) reported experiencing depressive symptoms. 41.83% of them (women and men) had high levels of state anxiety. All the students reported experiencing stress (e.g., due to uncertainty related to factors such as their finances, job, and social relationships). At T1, regular physical activity was negatively correlated with self-reported depression, anxiety, and perceived psychosomatic stress and positively correlated with quality of life and positive affect. Among women, cardiovascular fitness (operationalized as resting heart rate variability) was negatively correlated with self-reported anxiety (state) and depression at T1 (laboratory study). The 6 week aerobic exercise intervention resulted in significant improvements in self-reported depression, overall perceived stress, and perceived stress due to uncertainty. The present results confirm that there is a relationship between regular physical activity, cardiovascular fitness, mental health, and well-being among university students. They support the hypothesis that short-term aerobic exercise interventions can act as buffer against depression and perceived stress in university students after 6 weeks of aerobic exercise of low to moderate intensity.",2020,"The 6 week aerobic exercise intervention resulted in significant improvements in self-reported depression, overall perceived stress, and perceived stress due to uncertainty.","['185 university students were recruited from German universities at T1', 'university students in an online and a laboratory study', 'University Students', '74 (women: n = 67) students completed the 6-week intervention', 'university students', '32 (women: n = 30) participants completed the 2 week intervention (laboratory study']","['aerobic exercise intervention', 'regular physical activity and aerobic exercise', 'short-term aerobic exercise', 'aerobic exercise interventions', 'moderate-intensity aerobic exercise intervention', 'cognitive non-exercise control condition (online study), motor coordination exercise (laboratory study), and a waiting list (online and laboratory', 'aerobic exercise']","['regular physical activity', 'high levels of state anxiety', 'quality of life and positive affect', 'self-reported depression, overall perceived stress, and perceived stress due to uncertainty', 'depression, anxiety, positive and negative affect, perceived stress and coping strategies, body dissatisfaction, and quality of life', 'depression, anxiety, and perceived psychosomatic stress', 'experiencing depressive symptoms']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0203990', 'cui_str': 'Coordination exercise'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",74.0,0.0352719,"The 6 week aerobic exercise intervention resulted in significant improvements in self-reported depression, overall perceived stress, and perceived stress due to uncertainty.","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Herbert', 'Affiliation': 'Department of Applied Emotion and Motivation Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Meixner', 'Affiliation': 'Department of Applied Emotion and Motivation Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wiebking', 'Affiliation': 'Department of Applied Emotion and Motivation Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Gilg', 'Affiliation': 'Department of Applied Emotion and Motivation Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00509'] 2780,32528340,Effect of Psychotherapy on Reduction of Fear of Childbirth and Pregnancy Stress: A Randomized Controlled Trial.,"Introduction The fear of childbirth (FOC) has an adverse effect on the physical and mental health of pregnant women and increases adverse maternal and fetal outcomes. Previous research reported the effect of psychological interventions such as cognitive behavioral therapy, relaxation therapies, and short-term psycho-educational intervention on FOC. We examined whether adding motivational interviewing (MI) psychotherapy to prenatal usual care (PUC) is superior to PUC alone to reduce the scores of FOC, pregnancy stress, and self-efficacy. Materials and Methods An RCT with two-arm parallel groups and 1:1 allocation ratio assigned 70 pregnant women (aged 18-50) attending public health centers in an education hospital in Iran to receive five sessions of group MI psychotherapy plus PUC ( N = 35) or to receive PUC alone ( N = 35). The primary outcomes were the FOC scores (Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ), pregnancy-specific stress (Prenatal Distress Questionnaire, NuPDQ), anxiety (Spielberger state anxiety), and Childbirth Self-Efficacy Index (CBSI) at 5 weeks post-randomization. Additional measures included subscales of the W-DEQ and the NuPDQ, patients' compliance, and satisfaction with psychotherapy intervention at 5 weeks post-randomization as secondary outcomes. Main Results The post-trial results indicated that the outcome scores diminished more considerably in psychotherapy than in PUC for total FOC scale with a large effect size ( B = -23.54, p = < 0.001, η 2 η 2 = 0.27), for total pregnancy stress with a large effect size ( B = -4.51, p = < 0.001, η 2 = 19), and for state anxiety with a large effect size ( B = -12.42, p = < 0.001, η 2 = 0.22). However, the score of self-efficacy and concern about physical symptoms did not differ between the psychotherapy and PUC groups ( P < 0.05). Discussion Adding 5 weeks of group psychotherapy to PUC could be considered as an adjunctive care option for reducing FOC, pregnancy stress, and general anxiety in pregnant women in the third trimester. Future research may focus on sustaining the effects and evaluating the economic impacts of adding psychotherapy to PUC.",2020,"However, the score of self-efficacy and concern about physical symptoms did not differ between the psychotherapy and PUC groups ( P < 0.05). ","['pregnant women in the third trimester', '70 pregnant women (aged 18-50) attending public health centers in an education hospital in Iran to receive']","['Psychotherapy', 'motivational interviewing (MI) psychotherapy to prenatal usual care (PUC', 'five sessions of group MI psychotherapy plus PUC ( N = 35) or to receive PUC alone']","['FOC, pregnancy stress, and general anxiety', 'FOC scores (Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ), pregnancy-specific stress (Prenatal Distress Questionnaire, NuPDQ), anxiety (Spielberger state anxiety), and Childbirth Self-Efficacy Index (CBSI', ""subscales of the W-DEQ and the NuPDQ, patients' compliance, and satisfaction with psychotherapy intervention"", 'scores of FOC, pregnancy stress, and self-efficacy', 'fear of childbirth (FOC', 'score of self-efficacy and concern about physical symptoms', 'adverse maternal and fetal outcomes', 'total FOC scale', 'total pregnancy stress', 'Reduction of Fear of Childbirth and Pregnancy Stress', 'state anxiety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0522187', 'cui_str': 'Tocophobia'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",70.0,0.0609928,"However, the score of self-efficacy and concern about physical symptoms did not differ between the psychotherapy and PUC groups ( P < 0.05). ","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Abdollahi', 'Affiliation': 'Counseling in Midwifery, Student Research Committee, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mouloud Agajani', 'Initials': 'MA', 'LastName': 'Delavar', 'Affiliation': 'Community Health, Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bakouei', 'Affiliation': 'Reproductive Health, Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Chehrazi', 'Affiliation': 'Department of Epidemiology & Biostatics, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Gholinia', 'Affiliation': 'Biostatistics, Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00787'] 2781,32528372,The Bergen 4-Day Treatment (B4DT) for Obsessive-Compulsive Disorder: Outcomes for Patients Treated After Initial Waiting List or Self-Help Intervention.,"The Bergen 4-day treatment (B4DT) for obsessive-compulsive disorder (OCD) was recently tested in a randomized controlled trial, where the results showed that the B4DT was more effective than a self-help intervention (SH) and a waiting list condition (WL). Patients in the SH and WL condition still in need of treatment after the first intervention ( N = 26; 13 from each condition) were offered the B4DT. None of the patients declined participation, and there were no dropouts. At post-treatment 59.5% were in remission, 31.0% had treatment response, and 9.5% showed no change. At 3-month follow-up 71.4% were in remission, 19.0% had treatment response, and 9.5% showed no change. There were also significant improvement in self-reported symptoms of OCD, generalized anxiety symptoms, and depressive symptoms. The results are in line with what we previously have found for the B4DT in a number of effectiveness studies. In addition, the results indicate that the patients who previously had received an unsuccessful SH intervention and patients who had first been in a WL condition, profited as much as patients who had received the B4DT as the initial intervention. Implications for clinical guidelines and for dissemination of the B4DT are discussed.",2020,"There were also significant improvement in self-reported symptoms of OCD, generalized anxiety symptoms, and depressive symptoms.",['obsessive-compulsive disorder (OCD'],"['Bergen 4-day treatment (B4DT', 'Initial Waiting List or Self-Help Intervention', 'unsuccessful SH intervention', 'Bergen 4-Day Treatment (B4DT']","['self-reported symptoms of OCD, generalized anxiety symptoms, and depressive symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0185915,"There were also significant improvement in self-reported symptoms of OCD, generalized anxiety symptoms, and depressive symptoms.","[{'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Launes', 'Affiliation': 'Sørlandet Sykehus, Kristiansand, Norway.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars-Göran', 'Initials': 'LG', 'LastName': 'Öst', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Solem', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Kvale', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00982'] 2782,32527270,Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool.,"BACKGROUND Incorporating family-centered care principles into childhood obesity interventions is integral for improved clinical decision making, better follow-through, and more effective communication that leads to better outcomes and greater satisfaction with services. The purpose of this study is to evaluate the psychometric properties of a modified version of the Family Centered-Care Assessment (mFCCA) tool and to assess the family-centeredness of two clinical-community childhood obesity interventions. METHODS Connect for Health was a randomized trial testing the comparative effectiveness of two interventions that enrolled 721 children, ages 2-12 years, with a body mass index (BMI) ≥ 85th percentile. The two arms were (1) enhanced primary care; and (2) enhanced primary care plus contextually-tailored, health coaching. At the end of the one-year intervention, the mFCCA was administered. We used Rasch analyses to assess the tool's psychometrics and examined differences between the groups using multiple linear regression. RESULTS 629 parents completed the mFCCA resulting in an 87% response rate. The mean (SD) age of children was 8.0 (3.0) years. The exploratory factor analysis with 24 items all loaded onto a single factor. The Rasch modeling demonstrated good reliability as evidenced by the person separation reliability coefficient (0.99), and strong validity as evidenced by the range of item difficulty and overall model fit. The mean (SD, range) mFCCA score was 4.14 (0.85, 1-5). Compared to parents of children in the enhanced primary care arm, those whose children were in the enhanced primary care plus health coaching arm had higher mFCCA scores indicating greater perception of family-centeredness (β = 0.61 units [95% CI: 0.49, 0.73]). CONCLUSIONS Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management. TRIAL REGISTRATION Clinicaltrials.gov NCT02124460.",2020,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management. ","['enrolled 721 children, ages 2-12\u2009years, with a body mass index (BMI)\u2009≥\u200985th percentile', 'parents of children with obesity']","['modified version of the Family Centered-Care Assessment (mFCCA', 'primary care plus contextually-tailored, health coaching', 'mFCCA']","['mFCCA scores', 'mean (SD, range) mFCCA score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",721.0,0.0180158,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management. ","[{'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Simione', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA. msimione@mgh.harvard.edu.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Monica W', 'Initials': 'MW', 'LastName': 'Gerber', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Department of Pediatrics, Harvard Vanguard Medical Associates, Boston, MA, USA.'}, {'ForeName': 'Earlene', 'Initials': 'E', 'LastName': 'Avalon', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fiechtner', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Horan', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01431-y'] 2783,32527283,Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial.,"BACKGROUND This study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China. METHODS A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke or cardiovascular disease. The patients were randomly assigned to one of three systolic-BP target groups: standard: 140 to < 150 mmHg; moderately intensive: 130 to < 140 mmHg; and intensive: < 130 mmHg. The patients were followed for 6 months. DISCUSSION The optimal target for systolic blood pressure (SBP) lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7%, and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP-control protocols that fully consider the population's characteristics, such as age, sex, socio-economic status, compliance with medication, education level, and lifestyle. This randomized trial showed the feasibility and safety of the titration protocol to achieve desirable SBP targets (< 150, < 140, and < 130 mmHg) in a sample of rural, Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 h after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intensive group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups. This trial provided real-world experience and laid the foundation for a future, large-scale, BP target study. TRIAL REGISTRATION Feasibility Study of the Intensive Systolic Blood Pressure Control; ClinicalTrials.gov, ID: NCT02817503. Registered retrospectively on 29 June 2016.",2020,"Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups.","['105 hypertensive participants aged over 60\u2009years, and who had no history of stroke or cardiovascular disease', 'hypertensive patients of rural China', 'Chinese hypertensive patients', 'hypertensive patients of rural China ']",['systolic-BP target groups: standard: 140 to\u2009<\u2009150\u2009mmHg; moderately intensive: 130 to\u2009<\u2009140\u2009mmHg; and intensive: <\u2009130\u2009mmHg'],"['Rates of adverse events, including dry cough, palpitations, and arthralgia', 'Home BP and central aortic BP measurements', 'mean SBP', 'specific blood pressure (BP) control targets', 'serious adverse events', 'blood pressure control targets', 'home BP measurements']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",105.0,0.0519592,"Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Chonglei', 'Initials': 'C', 'LastName': 'Bi', 'Affiliation': 'Prevention and Control Office of Chronic Disease in Rongcheng, Rongcheng, Shangdong, China.'}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Yue', 'Affiliation': 'Disease Control and Prevention Center, Rongcheng, Shandong, China.'}, {'ForeName': 'Chongqian', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': ""People's Hospital of Rongcheng, Rongcheng, Shandong, China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Health and Family Planning Commission, Rongcheng, Shandong, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'Health Management College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Study Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Centers for Metabolic Disease Research, Temple University School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Department of Cardiovascular, Neural and Metabolic Sciences, S. Luca Hospital, Milan, Italy.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Spence', 'Affiliation': 'Stroke Prevention and Atherosclerosis Research Centre, Robarts Research Institute, Western University, London, ON, Canada.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MA, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China. huoyong@263.net.cn.'}, {'ForeName': 'Guangliang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'College of Integrated Traditional Chinese and Western Medicine, Anhui University of Chinese Medicine, Hefei, China. chguangl@163.com.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. drchengxiaoshu@163.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04368-1'] 2784,32527290,Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial.,"BACKGROUND Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS). METHODS The LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 25 0/7 and 31 6/7 weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined. DISCUSSION Data from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA's effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.",2020,"The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined. ","['preterm infants with respiratory distress syndrome (RDS', 'preterm infants', 'preterm infants with RDS by the LISA technique', '14 tertiary neonatal intensive care units in China', '600 preterm infants born with gestational age between 25 0/7 and 31 6/7 weeks and with a primary diagnosis of RDS will be involved in the study', 'preterm infants with respiratory distress syndrome in China']","['endotracheal intubation', 'surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation', 'invasive surfactant administration (LISA', 'LISA or LPPSA', 'endotracheal surfactant instillation']","['days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration', 'incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48\u2009h of surfactant administration, and the failure rates of each technique will be determined', 'mortality, severity of bronchopulmonary dysplasia at 36\u2009weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72\u2009h of life', 'peak pressure ventilation', 'effectiveness, safety and comorbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0151701', 'cui_str': 'Pulmonary hemorrhage'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.223819,"The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined. ","[{'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Women's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310006, China. jiajunzhu@zju.edu.cn.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Women's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310006, China.""}, {'ForeName': 'Lizhong', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': ""The Children's Hospital, Zhejiang University, School of Medicine, Hangzhou, 310052, China. dulizhong@zju.edu.cn.""}, {'ForeName': 'Huafei', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Jiaxing Maternity and Child Health Care Hospital, Jiaxing, 314051, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Ningbo Maternal and Children Hospital, Ningbo, 315012, China.'}, {'ForeName': 'Yejun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Shao Xing Maternity and Child Health Care Hospital, Shaoxing, 312000, China.'}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Central Hospital of Jinhua, Jinghua, 321000, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Boai Hospital of Zhongshan, Zhongshan, 528400, China.'}, {'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Gansu Provincial Maternity and Child-Care Hospital, Lanzhou, 730050, China.'}, {'ForeName': 'Yongyan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, 110004, China.'}, {'ForeName': 'Chuangzhong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Affiliated Shenzhen Maternity& Child Healthcare Hospital, Southern Medical University, Shenzhen, 518028, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Yan'an University Affiliated Hospital, Yan'an, 716000, China.""}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Chongqing Health Center for Women and Children, Chongqing, 400021, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Linyi People's Hospital, Linyi, 276003, China.""}]",Trials,['10.1186/s13063-020-04390-3'] 2785,32527322,Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial.,"BACKGROUND Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address their basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems. METHODS We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR), to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients' needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR. DISCUSSION This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC. TRIAL REGISTRATION ClinicalTrials.gov: NCT03885401. Registered on 19 September 2019.",2020,Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services.,"['patients with poorly controlled multiple chronic conditions (MCC', 'connecting patients with needed services', 'patients with multiple chronic conditions', '50 randomly selected patients for each clinician (3000 total', 'Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities']","['usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention', 'MCC']","['cardiovascular disease or risks, diabetes, obesity, or depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",50.0,0.0732347,Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services.,"[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA. ahkrist@vcu.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': ""O'Loughlin"", 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Woolf', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hinesley', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Anton J', 'Initials': 'AJ', 'LastName': 'Kuzel', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Rybarczyk', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Paulette Lail', 'Initials': 'PL', 'LastName': 'Kashiri', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'E Marshall', 'Initials': 'EM', 'LastName': 'Brooks', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capital Square Room 631, 830 East Main St, Richmond, VA, 23219, USA.'}, {'ForeName': 'Russel E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Huebschmann', 'Affiliation': 'Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Winston R', 'Initials': 'WR', 'LastName': 'Liaw', 'Affiliation': 'Department of Health Systems and Population Health Sciences, University of Houston College of Medicine, Houston, TX, USA.'}]",Trials,['10.1186/s13063-020-04463-3'] 2786,32527365,Low male partner attendance after syphilis screening in pregnant women leads to worse birth outcomes: the Syphilis Treatment of Partners (STOP) randomised control trial.,"Background: Maternal syphilis causes poor birth outcomes, including congenital syphilis. Testing and treatment of partners prevents reinfection, but strategies to improve partner attendance are failing. The aim of this study was to determine the effectiveness of three partner notification strategies. Methods: Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda, were randomised 1:1:1 to receive either notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls. The primary outcome was the proportion of partners who attended the ANC and were treated for syphilis. Results: Between 2015 and 2016, 17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study. Only 81 of 442 partners (18.3%; 23/152 (15.1%), 31/144 (21.5%) and 27/146 (18.5%) in the NS only, NS + SMS and NS + telephone call groups respectively) attended an ANC for follow-up; there were no significant differences between the groups. Twelve per cent of women attended the ANC with their male partner, and this proportion increased over time. Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). Conclusions: Only 18.3% of partners of pregnant women who tested positive for syphilis received treatment. Female partners of non-attendant men had worse birth outcomes. Encouraging men to accompany women to the ANC and testing both may address the urgent need to treat partners of pregnant women in sub-Saharan Africa to reduce poor fetal outcomes.",2020,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). ,"['17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study', 'Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda', 'Female partners of non-attendant men had worse birth outcomes', 'Low male partner attendance after syphilis screening in pregnant women', 'Results: Between 2015 and 2016', 'pregnant women who tested positive for syphilis received treatment']","['notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls']","['proportion of partners who attended the ANC', 'adverse birth outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}]",17130.0,0.183705,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). ,"[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Parkes-Ratanshi', 'Affiliation': ''}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Mbazira Kimeze', 'Affiliation': ''}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Nakku-Joloba', 'Affiliation': ''}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Hamill', 'Affiliation': ''}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Namawejje', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kiragga', 'Affiliation': ''}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Kayogoza Byamugisha', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rompalo', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gaydos', 'Affiliation': ''}, {'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': ''}]",Sexual health,['10.1071/SH19092'] 2787,32527382,"Treatment of Alcohol Dependence in Primary Care Compared With Outpatient Specialist Treatment: Twelve-Month Follow-Up of a Randomized Controlled Trial, With Trajectories of Change.","OBJECTIVE The purpose of this study was to investigate if brief treatment for alcohol dependence in primary care with the 15-method was as effective as specialist addiction care. In addition, we sought to investigate trajectories for change of alcohol consumption. METHOD This study was a randomized controlled noninferiority trial, between-groups parallel design, with a noninferiority limit of 50 g of alcohol per week. A total of 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic. The primary outcome was change in weekly alcohol consumption at the 12-month follow-up. Secondary outcomes were heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers. Trajectories were investigated using change in World Health Organization drinking risk levels. RESULTS The intention-to-treat analysis (n = 231) showed that the estimated weekly alcohol consumption in primary care was 18.2 g (95% CI [14.9, 51.3]) higher compared with specialist care (p = .28). Noninferiority was not demonstrated as the confidence interval exceeded the noninferiority limit. The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment. The analyses of trajectories showed the main part of change in consumption occurred from baseline to the 6-month follow-up and was maintained to the 12-month follow-up. CONCLUSIONS Although noninferiority could not be demonstrated, based on similar trajectories and sustained reduction of alcohol use, this study indicates brief treatment of alcohol dependence in primary care with the 15-method is a feasible and promising approach.",2020,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,['288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic'],['Outpatient Specialist Treatment'],"['change in weekly alcohol consumption', 'change in consumption', 'heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",288.0,0.0610297,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallhed Finn', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hammarberg', 'Affiliation': 'Department of Clinical Neurosciences, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}]",Journal of studies on alcohol and drugs,[] 2788,32527389,Effects of Age and Acute Moderate Alcohol Consumption on Electrophysiological Indices of Attention.,"OBJECTIVE Despite increased attention to risks and benefits associated with moderate drinking lifestyles among aging adults, relatively few empirical studies focus on acute alcohol effects in older drinkers. Using electroencephalographic indices of early attention modulation (P1 and N1) and later stimulus processing (P3), we investigated whether acute alcohol consumption at socially relevant doses differentially influences neurocognitive performance in older, relative to younger, moderate drinkers. METHOD Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers were randomly assigned to receive one of three alcohol doses (placebo, .04 g/dl, or .065 g/dl target breath alcohol concentrations). Repeated-measures analysis of variance examined the effects of age, alcohol dose concentration, and their potential interaction on P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task. RESULTS Age-specific effects on P1 amplitudes varied by instruction set, with alcohol-associated decreases in amplitude among older drinkers in response to task-relevant stimuli and increases to irrelevant stimuli, F(2, 141) = 2.70, p = .07, η p 2 = .04. In contrast, N1 analyses demonstrated alcohol-related latency reductions among older, relative to younger, adults, F(2, 83) = 3.42, p = .04. Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) = 5.73, p < .01, η p 2 = .08. CONCLUSIONS Our results underscore the impact of acute moderate alcohol consumption on attentional functioning, highlighting age-dependent sensitivity in electrophysiological indices of early attentional processing. Given the import of attentional functioning to quality of life and increases in drinking among a rapidly expanding aging population, these findings have broad public health relevance.",2020,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","['older drinkers', 'older, relative to younger, moderate drinkers', 'Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers']","['early attention modulation (P1 and N1) and later stimulus processing (P3', 'alcohol doses (placebo, .04']",['P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337677', 'cui_str': 'Moderate drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",87.0,0.0715192,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","[{'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'University of Florida Center for Addiction Research & Education, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[] 2789,32527719,Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention.,"INTRODUCTION Intensive lifestyle intervention (ILI) prevents progression from prediabetes to type 2 diabetes (T2D) but reversal of prediabetes is less well studied. RESEARCH DESIGN AND METHODS The overall objectives of the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study (ClinicalTrials.gov ID: NCT02027571) are to determine the natural history and reversibility of prediabetes. The study tests specific hypotheses on the patterns of progression to prediabetes among normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D; emergence of microvascular and macrovascular complications during transition from normal to impaired glucose regulation; significance of the 'metabolically healthy' obese phenotype; and effect of duration of the prediabetic state on its reversibility with lifestyle intervention. Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5 years. The primary outcome was restoration of normal glucose regulation (fasting plasma glucose <100 mg/dL and two-hour plasma glucose (2hrPG)<140 mg/dL). RESULTS Of the 223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI. The mean age was 53.3±9.28 years; body mass index 30.6±6.70 kg/m 2 ; 70% were female, 52.4% AA and 47.6% EA. The ILI program used goal setting, weight-based calorie restriction, physical activity (180 min/week), self-monitoring, and meal replacement. Monthly face-to-face (F2F) counseling sessions during the initial 6 months, and quarterly visits thereafter, were supplemented with electronic and postal contacts. Attendance at F2F sessions was highly correlated with weight loss (r=0.98, p<0.0001). Meal replacement induced ~5 kg weight loss within 3 months in participants with recrudescent weight pattern. Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001). CONCLUSION The PROP-ABC Study has demonstrated the feasibility of executing an ILI program designed to test reversibility of incident prediabetes in a biracial cohort.",2020,"Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001). ","['normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D', '223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI', 'The mean age was 53.3±9.28\u2009years; body mass index 30.6±6.70\u2009kg/m 2 ; 70% were female, 52.4% AA and 47.6% EA', 'Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5\u2009years', 'participants with recrudescent weight pattern']","['Meal replacement', 'lifestyle intervention', 'Intensive lifestyle intervention (ILI']","['restoration of normal glucose regulation (fasting plasma glucose <100\u2009mg/dL and two-hour plasma glucose (2hrPG)<140\u2009mg/dL', 'weight loss']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",158.0,0.0237108,"Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001). ","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA sdj@uthsc.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Brewer', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Ibiye', 'Initials': 'I', 'LastName': 'Owei', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'French', 'Affiliation': 'General Clinical Research Center, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Nkiru', 'Initials': 'N', 'LastName': 'Umekwe', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000899'] 2790,32527941,Comparing circulating tumor cell counts with dynamic tumor size changes as predictor of overall survival - a quantitative modeling framework.,"PURPOSE Quantitative relationships between treatment-induced changes in tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS), are lacking. We present a population modeling framework identifying and quantifying such relationships, based on longitudinal data collected in patients with metastatic colorectal cancer (mCRC) to evaluate the value of tumor size and CTC counts as predictors of OS. EXPERIMENTAL DESIGN A pharmacometric approach (i.e., population pharmacodynamic modeling) was used to characterize the changes in tumor size and CTC count and evaluate them as predictors of OS in 451 patients with mCRC treated with chemotherapy and targeted therapy in a prospectively randomized phase 3 study (CAIRO2). RESULTS A tumor size model of tumor quiescence and drug-resistance, was used to characterize the tumor size time-course, and was, in addition to the total normalized dose (i.e., of all administered drugs) in a given cycle, related to the CTC counts through a negative binomial model (CTC model). Tumor size changes did not contribute additional predictive value when the mean CTC count was a predictor of OS. Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94). The modeling framework was applied to explore if dose-modifications (increased and reduced) would result in a CTC count below 1/7.5 mL after 1-2 weeks of treatment. CONCLUSIONS Time-varying CTC counts can be useful for early predicting OS in patients with mCRC, and may therefore have potential for model-based treatment individualization. Although tumor size was connected to CTC, its link to OS was weaker.",2020,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"['patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', '451 patients with mCRC treated with']",['chemotherapy and targeted therapy'],"['tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS', 'typical mean count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",451.0,0.0171847,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Netterberg', 'Affiliation': 'Pharmaceutical Biosciences, Uppsala University.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, University of Uppsala, Sweden.'}, {'ForeName': 'Leon Wmm', 'Initials': 'LW', 'LastName': 'Terstappen', 'Affiliation': 'Medical Cell BioPhysics, University of Twente.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Medical Oncology, University Medical Center Utrecht.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Medical Oncology, Academic Medical Centre Amsterdam.'}, {'ForeName': 'Lena E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Pharmaceutical Biosciences, Uppsala University lena.friberg@farmbio.uu.se.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2570'] 2791,32527972,Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry.,"OBJECTIVE To explore clinical outcomes in older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT). METHODS We included consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry. We assessed the effect of age (dichotomized at ≥80 years and as continuous variable) on the modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate. The association between age and mRS was assessed with multivariable ordinal logistic regression, and a multiplicative interaction term was added to the model to assess modification of reperfusion by age on outcome. RESULTS Of the 1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults). Older adults had a worse functional outcome than younger patients (adjusted common odds ratio [acOR] for an mRS score shift toward better outcome 0.31, 95% confidence interval [CI] 0.24-0.39). Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19). There were no differences in proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates. Successful reperfusion was more strongly associated with a shift toward good functional outcome in older adults than in younger patients (acOR 3.22, 95% CI 2.04-5.10 vs 2.00, 95% CI 1.56-2.57, p interaction = 0.026). CONCLUSION Older age is associated with an increased absolute risk of poor clinical outcome, while the relative benefit of successful reperfusion seems to be higher in these patients. These results should be taken into consideration in the selection of older adults for EVT.",2020,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","['older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT', 'Older adults', 'consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry', 'older adults with acute ischemic stroke in the MR CLEAN Registry', '1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults']",['Endovascular treatment'],"['proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates', 'Mortality', 'modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate', 'functional outcome']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.144124,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","[{'ForeName': 'Adrien E', 'Initials': 'AE', 'LastName': 'Groot', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Ivo G H', 'Initials': 'IGH', 'LastName': 'Jansen', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Hinsenveld', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hanna C', 'Initials': 'HC', 'LastName': 'Willems', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands. j.coutinho@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009764'] 2792,32528046,Author Correction: Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat'],"['Placebo', 'Author Correction: Vitamin D Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.30447,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-020-67064-9'] 2793,32528273,Safety and Efficacy of 630-nm Red Light on Cognitive Function in Older Adults With Mild to Moderate Alzheimer's Disease: Protocol for a Randomized Controlled Study.,"Introduction: Studies have shown that excess formaldehyde accumulation in the brain accelerates cognitive decline in people with Alzheimer's disease (AD). Recently, reports from our research team revealed that red light treatment (RLT) improved memory in AD mice by activating formaldehyde dehydrogenase (FDH) and thus reducing formaldehyde levels. Here, we developed a medical RLT device to investigate the safety and efficacy of this device in older adults with mild to moderate AD. Methods: This will be a randomized controlled trial (RCT) that will include 60 participants who will be recruited and randomly divided into an RLT group and a control group. The RLT group will receive RLT intervention 5 days a week for 30 min each time for 24 weeks while the control group will continue their routine treatments without RLT. All participants will undergo neuropsychological and functional assessments including the Mini-Mental State Examination, the AD assessment scale-cognitive subscale (ADAS-cog), the Geriatric Depression Scale (GDS), the Neuropsychiatric Inventory (NPI) and the Barthel Index at baseline, 12 weeks and 24 weeks. All participants will undergo functional magnetic resonance imaging (fMRI) scanning and blood/urine biomarkers tests at baseline and 24 weeks. The primary outcome will be the ADAS-cog score while the secondary outcomes will be the GDS and NPI scores. Adverse events will be recorded and treated when necessary. Both an intention-to-treat analysis and a per-protocol analysis will be performed to evaluate the safety and efficacy of RLT. Discussion: This protocol outlines the objectives of the study and explained the RLT device developed by the research team. The study is designed as an RCT to evaluate the safety and effects of the RLT device on older adults with mild to moderate AD. This study will provide evidence for the clinical use of RLT on treatment for AD. Clinical Trial Registration: www.ClinicalTrials.gov, ChiCTR1800020163; Pre-results.",2020,The study is designed as an RCT to evaluate the safety and effects of the RLT device on older adults with mild to moderate AD.,"['60 participants who will be recruited and randomly divided into an', 'Older Adults', ""people with Alzheimer's disease (AD"", ""With Mild to Moderate Alzheimer's Disease"", 'older adults with mild to moderate AD']","['RLT intervention', '630-nm Red Light', 'RLT device', 'red light treatment (RLT', 'RLT']","['GDS and NPI scores', 'ADAS-cog score', 'Safety and Efficacy', 'Adverse events', 'Mini-Mental State Examination, the AD assessment scale-cognitive subscale (ADAS-cog), the Geriatric Depression Scale (GDS), the Neuropsychiatric Inventory (NPI) and the Barthel Index', 'Cognitive Function']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",60.0,0.262778,The study is designed as an RCT to evaluate the safety and effects of the RLT device on older adults with mild to moderate AD.,"[{'ForeName': 'Nayan', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yao', 'Affiliation': 'Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cuibai', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Innovation Center for Neurological Disorders, Xuan Wu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Mu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Maolong', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Institute for Geriatrics and Rehabilitation, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Zongjuan', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiqian', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00143'] 2794,32533236,Bracka verses Byar's two-stage repair in proximal hypospadias associated with severe chordee: a randomized comparative study.,"INTRODUCTION Proximal hypospadias associated with severe chordee represents a major surgical challenge and the debate over its optimal treatment is ongoing. The objective of this study is to compare the outcome of two-stage Bracka and Byar's repair in proximal hypospadias. MATERIALS AND METHODS This study was conducted from January 2013 to February 2018 in a tertiary care centre. Patients of hypospadias with severe chordee who required urethral plate transection were included in the study. Patients were randomly divided into two groups by simple randomization method. Bracka staged repair was done in Group A and Byar's staged repair in Group B. Postoperatively complications including graft loss, flap necrosis, fistula formation, meatal stenosis, stricture, diverticula formation, residual chordee were noted in both the groups and compared. p value of < 0.05 was considered statistically significant. RESULTS Over a period of 5 years, 74 patients in group A and 68 patients in group B were operated. Fistula occurred in 6.8% and 10.2% in group A and group B, respectively (p value 0.629). Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731). Stricture was seen in 1% in each group (p value 0.339). Diverticula formation was seen in 2% in group B and none of the patient in group A (p value 0.960). None of the patient had recurrence of chordee in either group. CONCLUSION Bracka and Byar's two-stage repair have similar postoperative outcome and the choice between the two depends up on the surgeon's choice and experience rather than scientific evidence.",2020,Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731).,"['January 2013 to February 2018 in a tertiary care centre', 'Patients of hypospadias with severe chordee who required urethral plate transection', 'proximal hypospadias associated with severe chordee']","[""Bracka verses Byar's two-stage repair""]","['Fistula', 'Diverticula formation', 'graft loss, flap necrosis, fistula formation, meatal stenosis, stricture, diverticula formation, residual chordee', 'recurrence of chordee', 'Meatal stenosis', 'Stricture']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221182', 'cui_str': 'Chordee'}, {'cui': 'C0440785', 'cui_str': 'Urethral plate'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0012817', 'cui_str': 'Diverticulum'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C4075512', 'cui_str': 'Flap necrosis'}, {'cui': 'C0431750', 'cui_str': 'Pinhole meatus'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221182', 'cui_str': 'Chordee'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0473903,Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731).,"[{'ForeName': 'Sajad Ahmad', 'Initials': 'SA', 'LastName': 'Wani', 'Affiliation': 'Consultant Paediatric Surgery and Paediatric Urology, GMC Srinagar, Married Hostel, Room No 205, Srinagar, Jammu and Kashmir, 190001, India. wanisajad862@gmail.com.'}, {'ForeName': 'Aejaz Ahsan', 'Initials': 'AA', 'LastName': 'Baba', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Gowhar Nazir', 'Initials': 'GN', 'LastName': 'Mufti', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Kumar Abdul', 'Initials': 'KA', 'LastName': 'Rashid', 'Affiliation': 'Consultant Paediatric Surgery and Paediatric Urology, GMC Srinagar, Married Hostel, Room No 205, Srinagar, Jammu and Kashmir, 190001, India.'}, {'ForeName': 'Nisar Ahmad', 'Initials': 'NA', 'LastName': 'Bhat', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Mudasir', 'Initials': 'M', 'LastName': 'Buch', 'Affiliation': 'Registrar Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Mir', 'Initials': 'M', 'LastName': 'Faheem', 'Affiliation': 'Registrar Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}]",Pediatric surgery international,['10.1007/s00383-020-04697-x'] 2795,32533243,Anodal transcranial direct current stimulation enhances strength training volume but not the force-velocity profile.,"PURPOSE This study aimed to explore the acute effect of transcranial direct current stimulation (tDCS) on the force-velocity relationship, strength training volume, movement velocity, and ratings of perceived exertion. METHODS Fourteen healthy men (age 22.8 ± 3.0 years) were randomly stimulated over the dorsolateral prefrontal cortex with either ANODAL, CATHODAL or SHAM tDCS for 15 min at 2 mA. The one-repetition maximum (1RM) and force-velocity relationship parameters were evaluated during the bench press exercise before and after receiving the tDCS. Subsequently, participants completed a resistance training session consisting of sets of five repetitions with 1 min of inter-set rest against the 75%1RM until failure. RESULTS No significant changes were observed in the 1RM or in the force-velocity relationship parameters (p ≥ 0.377). The number of repetitions was higher for the ANODAL compared to the CATHODAL (p = 0.025; ES = 0.37) and SHAM (p = 0.009; ES = 0.47) conditions. The reductions of movement velocity across sets were lower for the ANODAL than for the CATHODAL and SHAM condition (p = 0.014). RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions. No significant differences between the CATHODAL and SHAM conditions were observed for any variable. CONCLUSION The application of ANODAL tDCS before a resistance training session increased training volume, enabled the maintenance of higher movement velocities, and reduced RPE values. These results suggest that tDCS could be an effective method to enhance resistance-training performance.",2020,RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions.,['Fourteen healthy men (age 22.8\u2009±\u20093.0\xa0years'],"['transcranial direct current stimulation (tDCS', 'SHAM tDCS', 'Anodal transcranial direct current stimulation enhances strength training', 'tDCS']","['higher movement velocities, and reduced RPE values', 'repetition maximum (1RM) and force-velocity relationship parameters', 'reductions of movement velocity', 'number of repetitions', 'RPE values', 'force-velocity relationship, strength training volume, movement velocity, and ratings of perceived exertion']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",14.0,0.0394359,RPE values were lower for the ANODAL compared to the CATHODAL (p = 0.119; ES = 0.33) and SHAM (p = 0.150; ES = 0.44) conditions.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Alix-Fages', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sport Sciences and Physical Conditioning, Faculty of Education, Universidad Catolica de la Santisima Concepcion, Concepción, Chile.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Calderón-Nadal', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Colomer-Poveda', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernández-Del-Olmo', 'Affiliation': 'Department of Education, King Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Márquez', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, Catholic University of Murcia (UCAM), Campus de los Jerónimos, s/n, Guadalupe, 30107, Murcia, Spain. gmarquez@ucam.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04417-2'] 2796,32533264,Immediate versus delayed loading of strategic mini-implants under existing removable partial dentures: patient satisfaction in a multi-center randomized clinical trial.,"OBJECTIVE The purpose of this study was to evaluate and compare the effects of the immediate and delayed loading of strategic mini-implants (MIs) on the satisfaction of patients with removable partial dentures (RPDs). MATERIALS AND METHODS In this multi-center randomized clinical trial, strategic MIs were inserted under 79 RPDs in 76 participants. Two questionnaires, one for the upper jaw and one for the lower jaw, were given before surgical intervention and 2 weeks, 4 months, 4.5 months, 1 year, 2 years, and 3 years after implant insertion. To estimate the loading effect (immediate vs. delayed) in terms of the odds ratio, an ordinal logistic regression model was used. The Wilcoxon matched-pairs signed-rank test, which was corrected for clusters in the patient population, was used to evaluate changes in patient satisfaction. RESULTS After 4 months, a statistically significant difference in favor of the immediate loading group was recognized in terms of the overall satisfaction score. The patient satisfaction scores recorded after 4.5 months and 1, 2, and 3 years showed substantial improvements compared with the scores recorded before implant insertion in both groups. At the item level, substantial improvements were noted in the following domains: general satisfaction, RPD retention, stability, support, eating, speaking, and aesthetics. CONCLUSIONS Strategic MIs improved the satisfaction of patients with RPDs during the medium-term follow-up period. An earlier improvement in the satisfaction of patients with RPDs was seen after immediate loading of the MIs as compared with delayed loading. CLINICAL RELEVANCE Inserting MIs under existing RPDs can improve patients' satisfaction with their RPDs in several domains.",2020,"After 4 months, a statistically significant difference in favor of the immediate loading group was recognized in terms of the overall satisfaction score.","['patients with removable partial dentures (RPDs', '76 participants']","['strategic mini-implants (MIs', 'Strategic MIs', 'Immediate versus delayed loading of strategic mini-implants']","['general satisfaction, RPD retention, stability, support, eating, speaking, and aesthetics', 'patient satisfaction scores', 'overall satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0659574,"After 4 months, a statistically significant difference in favor of the immediate loading group was recognized in terms of the overall satisfaction score.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al Jaghsi', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Dental Materials, Greifswald University Medicine, Greifswald, Germany. a.aljaghsi@ajman.ac.ae.'}, {'ForeName': 'Friedhelm', 'Initials': 'F', 'LastName': 'Heinemann', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Dental Materials, Greifswald University Medicine, Greifswald, Germany.'}, {'ForeName': 'Reiner', 'Initials': 'R', 'LastName': 'Biffar', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Dental Materials, Greifswald University Medicine, Greifswald, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Mundt', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Dental Materials, Greifswald University Medicine, Greifswald, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03360-y'] 2797,32533295,Internet-Delivered Parent Training for Preschoolers with Conduct Problems: Do Callous-Unemotional Traits Moderate Efficacy and Engagement?,"Recent efforts to improve access to evidence-based parent training programs using online delivery have largely neglected findings that young children with callous-unemotional (CU)-type conduct problems receive less benefit from parent training than children with conduct problems alone. The current study aimed to examine the moderating effect of child CU traits on efficacy and engagement outcomes associated with Internet-delivered Parent-Child Interaction Therapy (iPCIT) versus standard, clinic-based PCIT. Forty families (57.6% non-Hispanic Caucasian) with a 3-5 year-old (M = 3.95 years, SD = 0.9; 83.5% boys) child with a disruptive behavior disorder were randomized to either iPCIT or clinic-based PCIT. Families participated in four assessments across time; child conduct problems, global functioning and treatment responder status, and parent-rated treatment satisfaction were measured. Analyses revealed that the negative influence of CU traits on functional gains was not uniform across treatment formats. Specifically, the detrimental effect of CU traits on functional gains was significantly more pronounced among children treated with iPCIT than clinic-based PCIT. CU traits also predicted lower parental treatment satisfaction across delivery formats, but this effect was more pronounced among iPCIT parents. In contrast, CU traits did not moderate differential effects across iPCIT and clinic-based PCIT for conduct problem severity or treatment response status. Findings suggest that iPCIT is a promising treatment option for early conduct problems, particularly when access-to-care barriers exist, but that further research is needed to determine whether strategic adaptations to online programs can more optimally address the distinct needs of children with clinically significant CU traits.",2020,"In contrast, CU traits did not moderate differential effects across iPCIT and clinic-based PCIT for conduct problem severity or treatment response status.","['Preschoolers with Conduct Problems', 'young children with callous-unemotional (CU)-type conduct problems', 'Forty families (57.6% non-Hispanic Caucasian) with a 3-5\xa0year-old (M\u2009=\u20093.95\xa0years, SD\u2009=\u20090.9; 83.5% boys) child with a disruptive behavior disorder']","['Internet-delivered Parent-Child Interaction Therapy (iPCIT) versus standard, clinic-based PCIT', 'iPCIT or clinic-based PCIT', 'iPCIT', 'Internet-Delivered Parent Training']","['time; child conduct problems, global functioning and treatment responder status, and parent-rated treatment satisfaction', 'functional gains']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0376154', 'cui_str': 'Callosity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012734', 'cui_str': 'Disruptive behavior disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",40.0,0.054209,"In contrast, CU traits did not moderate differential effects across iPCIT and clinic-based PCIT for conduct problem severity or treatment response status.","[{'ForeName': 'Georgette E', 'Initials': 'GE', 'LastName': 'Fleming', 'Affiliation': 'School of Psychology, The University of New South Wales, Sydney, New South Wales, Australia. g.fleming@unsw.edu.au.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Kimonis', 'Affiliation': 'School of Psychology, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jami M', 'Initials': 'JM', 'LastName': 'Furr', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, Florida, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-020-00660-5'] 2798,32533314,"Randomized controlled trial of landiolol, a short-acting beta-1 adrenergic receptor blocker, illustrating changes in high-molecular weight adiponectin levels after elective percutaneous coronary intervention.","Adiponectin (APN) has cardioprotective properties and bisoprolol has been reported to increase myocardial APN expression and reduce myocardial damage. Administration of landiolol, which has a higher cardio-selectivity and shorter half-life than bisoprolol, during the percutaneous coronary intervention (PCI) may increase serum APN and high-molecular weight (HMW)-APN, an active form of APN, in patients with stable angina pectoris (SAP). We recruited 70 patients with SAP and randomized them to intravenous landiolol during PCI (N = 35) or control group (N = 35). The primary endpoint was serum APN and HMW-APN level 3 days after PCI. There was no difference in the primary endpoint between the landiolol and control groups (8.93 ± 5.24 vs. 10.18 ± 5.81 μg/mL, p = 0.35 and 3.36 ± 2.75 vs. 4.28 ± 3.13 μg/mL, p = 0.20) for APN and HMW-APN levels, respectively. APN and HMW-APN level were significantly decreased 1 day after PCI [-0.55 ± 0.92 μg/mL (9.87-9.32 μg/mL), p < 0.001 and -0.20 ± 0.45 μg/mL (3.89-3.69 μg/mL), p < 0.001, respectively]. Additionally, the absolute change in HMW-APN was significantly smaller in the landiolol group compared to the control group (-0.08 ± 0.27 vs. -0.31 ± 0.55 μg/mL, p = 0.031). Multiple linear regression analysis showed that use of landiolol was an independent predictor of change in HMW-APN (β = 0.276, p = 0.014). Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol. APN and HMW-APN decreased 1 day after PCI in the SAP and landiolol mitigated decrease in HMW-APN.",2020,Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol.,"['70 patients with SAP and randomized them to', 'elective percutaneous coronary intervention', 'patients with stable angina pectoris (SAP']","['percutaneous coronary intervention (PCI', 'Adiponectin (APN', 'intravenous landiolol during PCI (N\u2009=\u200935) or control group', 'mL', 'landiolol']","['myocardial APN expression and reduce myocardial damage', 'HMW-APN (β', 'APN and HMW-APN level', 'HMW-APN', 'Serum APN and HMW-APN level', 'absolute change in HMW-APN', 'APN and HMW-APN', 'serum APN and HMW-APN level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.162417,Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol.,"[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kiyokuni', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. m_koni@hotmail.com.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saigusa', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Iwata', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Komura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Teruyasu', 'Initials': 'T', 'LastName': 'Sugano', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ishigami', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01637-6'] 2799,32528568,Clinical factors related to successful or unsuccessful cardioversion in the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) randomized trial.,"Background EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation evaluated use of nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing electrical cardioversion. Hypothesis To assess clinical factors related to successful or unsuccessful cardioversion. To evaluate whether differences in adverse events based on anticoagulation strategy may exist. Methods In this multicenter prospective randomized open-label blinded end-point evaluation trial, 2199 patients were randomized to edoxaban 60 mg once daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤ 60 kg, and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Successful cardioversion was confirmed by 12-lead electrocardiography-documented sinus rhythm. Results Cardioversion was successful in 1578 patients; in 355 patients, cardioversion was unsuccessful. Male, high body weight, high body mass index (BMI), coronary artery disease, concomitant aspirin, or prior statins use were more common in patients with unsuccessful cardioversion; international normalized ratio control did not differ by cardioversion success. On multivariate analysis, gender ( P  < .05), body weight ( P  = .0196) and BMI ( P  = .0377) emerged as independent predictors of successful cardioversion. There were no significant differences in primary efficacy (a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during overall study period) regardless of cardioversion success. There were no significant differences in bleeding rates, regardless of cardioversion outcome; notwithstanding low numbers, edoxaban and enoxaparin-warfarin did not differ. Conclusions Male gender, higher mean weight and higher mean BMI were associated with unsuccessful cardioversion. Efficacy and safety outcomes were low and did not differ by cardioversion success.",2020,"On multivariate analysis, gender ( P  < .05), body weight ( P  = .0196) and BMI ( P  = .0377) emerged as independent predictors of successful cardioversion.","['subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF', '2199 patients', 'subjectS UndeRgoing cardiovErsion of Atrial Fibrillation', 'patients with nonvalvular atrial fibrillation undergoing electrical cardioversion']","['nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin-warfarin', 'edoxaban 60\xa0mg once daily (30\xa0mg for creatinine clearance 15-50\xa0mL/min, weight', 'EdoxabaN versus warfarin', 'enoxaparin-warfarin', '\n\n\nEdoxabaN versus warfarin']","['mean weight and higher mean BMI', 'body weight', 'BMI', 'Male, high body weight, high body mass index (BMI), coronary artery disease', 'Efficacy and safety outcomes', 'primary efficacy (a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during overall study period) regardless of cardioversion success', 'bleeding rates']","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",2199.0,0.0816285,"On multivariate analysis, gender ( P  < .05), body weight ( P  = .0196) and BMI ( P  = .0377) emerged as independent predictors of successful cardioversion.","[{'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool UK.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Merino', 'Affiliation': 'Hospital Universitario La Paz Universidad Europea Madrid Spain.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension Medical Univeristy of Lodz Lodz Poland.'}, {'ForeName': 'Naab', 'Initials': 'N', 'LastName': 'Al-Saady', 'Affiliation': 'Covance Inc. Osprey House Littlewick Green UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Daiichi Sankyo Pharma Development Basking Ridge NJ USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Melino', 'Affiliation': 'Daiichi Sankyo Pharma Development Basking Ridge NJ USA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Winters', 'Affiliation': 'Daiichi Sankyo, Inc. Basking Ridge NJ USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kozieł', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'St Vincenz Hospital Paderborn Germany.'}]",Journal of arrhythmia,['10.1002/joa3.12341'] 2800,32528571,A multicenter study comparing the outcome of catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation in patients with heart failure (CRABL-HF): Study design.,"Background Catheter ablation of atrial fibrillation (AF) is increasingly performed worldwide in patients with heart failure (HF). However, it has been recently emphasized that AF ablation in patients with HF is associated with increased risks of procedure-related complications and mortality. There are little data about the differences in the efficacy and safety between cryoballoon (CB) and radiofrequency (RF) ablation of AF in patients with HF. Methods The CRABL-HF study is designed as a prospective, multicenter, open-label, controlled, and randomized clinical trial comparing the efficacy and safety of AF ablation between CB and RF ablation in patients with HF (LVEF ≤40%) (UMIN Clinical Trials Registry UMIN000032433). The CRABL-HF study will consist of 110 patients at multicenter in Japan. The patients will be registered and randomly assigned to either the CB ablation or RF ablation group with a 1:1 allocation. The primary endpoint of this study is the occurrence of atrial tachyarrhythmias (ATs) at 1 year with a blanking period of 90 days after ablation. Key secondary endpoints are the success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all-cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life. Results The results of this study are currently under investigation. Conclusion The CRABL-HF study is being conducted to compare the efficacy and safety of catheter ablation of AF between CB and RF ablation in patients with HF.",2020,"Key secondary endpoints are the success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all-cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life. ","['patients with HF', 'patients with HF (LVEF\xa0≤40', '110 patients at multicenter in Japan', 'patients with heart failure (CRABL-HF', 'patients with heart failure (HF']","['CB ablation or RF ablation', 'catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation', 'AF ablation between CB and RF ablation', '\n\n\nCatheter ablation of atrial fibrillation (AF']","['success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all-cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life', 'efficacy and safety between cryoballoon (CB) and radiofrequency (RF) ablation of AF', 'occurrence of atrial tachyarrhythmias (ATs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}]",110.0,0.0361318,"Key secondary endpoints are the success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all-cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life. ","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Cardiovascular Medicine University of Fukui Yoshida Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medicine II Kansai Medical University Hirakata Japan.'}, {'ForeName': 'Yoh', 'Initials': 'Y', 'LastName': 'Masue', 'Affiliation': 'Second Department of Internal Medicine University of Toyama Toyama Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Kataoka', 'Affiliation': 'Second Department of Internal Medicine University of Toyama Toyama Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Fukuzawa', 'Affiliation': 'Section of Arrhythmia Division of Cardiovascular Medicine Department of Internal Medicine Kobe University Graduate School of Medicine Kobe Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikaga', 'Affiliation': 'Department of Cardiovascular Medicine Miyazaki Medical Association Hospital Miyazaki Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Satomi', 'Affiliation': 'Department of Cardiovascular Medicine Tokyo Medical University Hospital Tokyo Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine University of Fukui Yoshida Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Medicine II Kansai Medical University Hirakata Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita Japan.'}]",Journal of arrhythmia,['10.1002/joa3.12322'] 2801,32528599,"Use of low-dose acetylsalicylic acid for cardiovascular disease prevention: A practical, stepwise approach for pharmacists.","Low-dose acetylsalicylic acid (ASA) is recommended in patients with established cardiovascular disease. However, the role of ASA in those without cardiovascular disease (i.e., primary prevention) is less clear, which has led to discordance among Canadian guidelines. In 2018, 3 double-blind, randomized controlled trials were published that evaluated ASA 100 mg daily versus placebo in patients without established cardiovascular disease. In the ASPREE trial, ASA did not reduce the risk of all-cause death, dementia, or persistent physical disability in patients ≥70 years of age but increased the risk of major bleeding. In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease. In the ASCEND trial, ASA significantly reduced the primary composite cardiovascular outcome in patients with diabetes for a number needed to treat of 91 over approximately 7.4 years. Yet major bleeding was increased with ASA for a number needed to harm of 112. Therefore, in most situations, ASA should not be recommended for primary cardiovascular prevention. However, there are additional indications for ASA beyond cardiovascular disease. Thus, a sequential algorithm was developed based on contemporary evidence to help pharmacists determine the suitability of ASA in their patients and play an active role in educating their patients about the potential benefits (or lack thereof) and risks of ASA. Can Pharm J (Ott) 2020;153:xx-xx.",2020,"In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease.","['patients with diabetes for a number needed to treat of 91 over approximately 7.4 years', 'patients without established cardiovascular disease', 'patients with established cardiovascular disease']","['ASA 100 mg daily versus placebo', 'Low-dose acetylsalicylic acid (ASA', 'low-dose acetylsalicylic acid']","['risk of all-cause death, dementia, or persistent physical disability', 'risk of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.389225,"In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease.","[{'ForeName': 'Arden R', 'Initials': 'AR', 'LastName': 'Barry', 'Affiliation': 'Chilliwack General Hospital (Barry), University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Semchuk', 'Affiliation': 'Chilliwack General Hospital (Barry), University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Chilliwack General Hospital (Barry), University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Marlys H', 'Initials': 'MH', 'LastName': 'LeBras', 'Affiliation': 'Chilliwack General Hospital (Barry), University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Koshman', 'Affiliation': 'Chilliwack General Hospital (Barry), University of British Columbia, Vancouver, British Columbia.'}]",Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC,['10.1177/1715163520909137'] 2802,32528630,Effect of nutritional supplement formula on catch-up growth in young children with nonorganic faltering growth: a prospective multicenter study.,"BACKGROUND/OBJECTIVES Inadequate nutrition in infants and young children affects physical growth and neurocognitive development. Therefore, early nutritional intervention is important to promote catch-up growth in young children with faltering growth. The aim of this study was to evaluate the effect of nutritional supplementation with a pediatric concentrated and balanced nutritional supplement formula on promoting growth and improving nutritional status in children with nonorganic faltering growth. SUBJECTS/METHODS Children aged 12-36 months whose body weight-for-age was < 5 th percentile on the Korean Growth Charts were enrolled. Children born premature or having organic diseases were excluded. Children were instructed to consume 400 mL of formula per day in addition to their regular diet for 6 months. Pediatricians and dietitians educated the parents and examined the subjects every 2 months. Anthropometric parameters were measured at baseline and at 2, 4, and 6 months, and laboratory tests were done at baseline and 6 months. The good consumption group included children who consumed ≥ 60% of the recommended dose of formula. RESULTS Total 82 children completed the 6-month intervention. At baseline, there were no significant differences in all variables between the good consumption and poor consumption groups. Weight and weight z-scores were significantly improved in the good consumption group compared to the poor consumption group at the end of the intervention ( P = 0.009, respectively). The good consumption group showed a significant trend for gaining weight ( P < 0.05) and weight z-score ( P < 0.05) compared to the poor consumption group during 6 months of formula intake. The concentration of blood urea nitrogen was significantly increased in the good consumption group ( P = 0.001). CONCLUSIONS Nutritional supplementation with a concentrated and balanced pediatric nutritional formula along with dietary education might be an effective approach to promote catch-up growth in children with nonorganic faltering growth.",2020,The good consumption group showed a significant trend for gaining weight ( P < 0.05) and weight z-score ( P < 0.05) compared to the poor consumption group during 6 months of formula intake.,"['young children with faltering growth', 'children with nonorganic faltering growth', 'infants and young children', 'Children aged 12-36 months whose body weight-for-age was < 5 th percentile on the Korean Growth Charts were enrolled', 'Children born premature or having organic diseases', 'young children with nonorganic faltering growth', 'Total 82 children']","['nutritional supplementation with a pediatric concentrated and balanced nutritional supplement formula', 'nutritional supplement formula']","['Anthropometric parameters', 'gaining weight', 'catch-up growth', 'weight z-score', 'concentration of blood urea nitrogen', 'Weight and weight z-scores', 'nutritional status']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0015544', 'cui_str': 'Failure to thrive'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2718056', 'cui_str': 'Growth Charts'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",82.0,0.0164506,The good consumption group showed a significant trend for gaining weight ( P < 0.05) and weight z-score ( P < 0.05) compared to the poor consumption group during 6 months of formula intake.,"[{'ForeName': 'Jung Ok', 'Initials': 'JO', 'LastName': 'Shim', 'Affiliation': 'Department of Pediatrics, Korea University Guro Hospital, Korea University College of Medicine, Seoul 08308, Korea.'}, {'ForeName': 'Seung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Pediatrics, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Choe', 'Affiliation': 'Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu 41404, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department of Pediatrics, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Gyeongsang Institute of Sciences, Jinju 52727, Korea.'}, {'ForeName': 'Hye Ran', 'Initials': 'HR', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Seoul National University Bundang Hospital, Seongnam 13620, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.3.230'] 2803,32528633,Evidence-based customized nutritional intervention improves body composition and nutritional factors for highly-adherent children and adolescents with moderate to severe obesity.,"BACKGROUND/OBJECTIVES Evidence-based customized nutritional interventions are required for effective treatment of moderate to severe obese children and adolescents. SUBJECTS/METHODS Sixty six (64.1% of 103) of the eligible participants who joined the usual care or physical activity group in the clinic were involved in 16-week intervention. Customized nutritional intervention was implemented for each participant based on a nutrition care process (NCP) model. Sociodemographic assessment, anthropometrics data, health- and dietary-related behaviors, and dietary intake of the study subjects were assessed at baseline and follow-up. All participants engaged in 30-minute nutritional sessions on a monthly basis. RESULTS After 16 weeks, there were significant improvements in body composition [BMI (-0.8 ± 0.9, P < 0.05), BMI z-score (-0.3 ± 0.2, P < 0.001), body fat (kg) (-1.3 ± 2.1, P < 0.05), and body fat (%)(-1.5 ± 1.9, P < 0.05)] as well as macronutrient intake [total energy intake (kcal) (-563.7 ± 656.8, P < 0.05), energy (%) (-26.5 ± 30.0, P < 0.05) and fat (g) (-28.3 ± 40.6, P < 0.05)] in the adherent group than the non-adherent group. The SOC was higher in both groups after the intervention ( P < 0.001). CONCLUSIONS Our results highlight the positive effects of an evidence-based approach as a multidisciplinary intervention for people-centered nutritional care and weight management.",2020,"The SOC was higher in both groups after the intervention ( P < 0.001). ","['Sixty six (64.1% of 103) of the eligible participants who joined the usual care or physical activity group in the clinic were involved in 16-week intervention', 'moderate to severe obese children and adolescents', 'highly-adherent children and adolescents with moderate to severe obesity']","['Customized nutritional intervention', 'Evidence-based customized nutritional intervention']","['body composition [BMI', 'macronutrient intake [total energy intake (kcal', 'SOC', 'body composition and nutritional factors', 'BMI z-score', 'Sociodemographic assessment, anthropometrics data, health- and dietary-related behaviors, and dietary intake', 'body fat']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",,0.0219708,"The SOC was higher in both groups after the intervention ( P < 0.001). ","[{'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yongin 17104, Korea.'}, {'ForeName': 'YoonMyung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'University College, Yonsei University International Campus, Incheon 21983, Korea.'}, {'ForeName': 'Young-Gyun', 'Initials': 'YG', 'LastName': 'Seo', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.'}, {'ForeName': 'Kyung-Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.'}, {'ForeName': 'Han Byul', 'Initials': 'HB', 'LastName': 'Jang', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju 28159, Korea.'}, {'ForeName': 'Hye-Ja', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju 28159, Korea.'}, {'ForeName': 'Sang Ick', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju 28159, Korea.'}, {'ForeName': 'Hyunjung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yongin 17104, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.3.262'] 2804,32528634,Mukbang- and Cookbang-watching status and dietary life of university students who are not food and nutrition majors.,"BACKGROUND/OBJECTIVES As watching food-related programs has become very popular among the young generation in Korea, this study sought to compare the Mukbang- and Cookbang-watching status of university students with their dietary life. SUBJECTS/METHODS The participants were 380 students who were not majoring in food and nutrition at a university in Gyeonggi, Korea. Based on self- reports, the participants were grouped according to their frequency of watching Mukbang or Cookbang: frequent-watching (FW) 21.1% and 5.3%, respectively; moderate-watching (MW) 43.9% and 27.9%, respectively; and not-watching (NW) 35.0% and 66.8% respectively. RESULTS In the FW group, up to 88.8% and 70.0% of participants reported watching Mukbang and Cookbang, respectively, ≥ 3 days/week. Almost all participants in the FW and MW groups reported intention to keep watching these shows. The most frequent watching route was ""YouTube"" and the most important criterion to select a program was ""food"". In the case of Mukbang, but not Cookbang, the participants in the FW group scored their diet significantly worse than those in the NW group ( P < 0.05). A greater proportion of participants felt that watching Cookbang improved their diets rather than worsened them (14.3% vs. 0.8%, respectively), while more participants said that watching Mukbang worsened their diets rather than improved them (8.1% vs. 2.4%, respectively). In both cases, greater differences were shown in the FW groups compared to the MW groups ( P < 0.05 and P < 0.01 for Cookbang and Mukbang, respectively). Moreover, the participants answered that Mukbang-watching prompted them to eat more of less desirable food, such as through eating out and purchasing convenient and delivered foods, whereas Cookbang-watching made them want to cook more of their own food. CONCLUSIONS Our results suggested that Korean university students who frequently watch Mukbang, but not Cookbang, may be a nutritionally vulnerable group that needs attention.",2020,"In both cases, greater differences were shown in the FW groups compared to the MW groups ( P < 0.05 and P < 0.01 for Cookbang and Mukbang, respectively).","['university students who are not food and nutrition majors', 'Korean university students', 'university students with their dietary life', 'participants were 380 students who were not majoring in food and nutrition at a university in Gyeonggi, Korea']",[],[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]",[],[],380.0,0.0337821,"In both cases, greater differences were shown in the FW groups compared to the MW groups ( P < 0.05 and P < 0.01 for Cookbang and Mukbang, respectively).","[{'ForeName': 'Sowon', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': 'Graduate School of Education, Daejin University, Pocheon 11159, Korea.'}, {'ForeName': 'Hyunjoo', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Food & Nutrition, Bucheon University, Bucheon 14632, Korea.'}, {'ForeName': 'Hongmie', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Graduate School of Education, Daejin University, Pocheon 11159, Korea.'}]",Nutrition research and practice,['10.4162/nrp.2020.14.3.276'] 2805,32528678,"Bulgarian consumers' objective understanding of front-of-package nutrition labels: a comparative, randomized study.","Background Bulgaria continues to lag behind other EU Member States with respect to chronic disease morbidity and mortality prevention. Methods In line with efforts targeting the improvement of dietary practices, this comparative study assessed objective understanding of five different front-of-package labels (FOPL) (Reference Intakes, Multiple Traffic Lights, Warning label, Nutri-Score, and Health Star Rating) in a sample of 1010 Bulgarian adults. Objective understanding was assessed by comparing the results of two nutritional quality ranking tasks (with and without FOPL) in an online randomized experiment featuring three food categories (pizza, cakes, breakfast cereals). Multivariable ordinal logistic regression models within and across food categories were fit. Results Compared with the Reference Intakes group, participants randomized to Nutri-Score exhibited the largest improvement in product ranking ability across food categories (OR = 2.33; 95% CI: 1.55-3.51), followed by those randomized to Health Star Rating (OR = 1.99; 95% CI: 1.32-3.00). Nutri-Score also performed best within two (pizza and breakfast cereals) of the three food categories. The Multiple Traffic Lights and Warning label groups did not display any significant improvement in objective understanding either within or across food categories compared with the Reference Intakes group. Conclusion Nutri-Score, which is a summary, interpretive, polychromatic FOPL, emerged as the most effective model in the Bulgarian context, with the potential to help consumers better understand the nutritional quality of food. The findings are of particular interest to public health policymakers in the region and across Europe, as the debate about an EU-wide FOPL model continues to gather momentum. Trial registration Registration number ACTRN12618001221246. Trial registered at the Australian New Zealand Clinical Trials Registry.",2020,"The Multiple Traffic Lights and Warning label groups did not display any significant improvement in objective understanding either within or across food categories compared with the Reference Intakes group. ",['1010 Bulgarian adults'],['nutritional quality ranking tasks (with and without FOPL'],[],"[{'cui': 'C0006369', 'cui_str': 'Bulgarian language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0699794', 'cui_str': 'Rank'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",[],1010.0,0.0659117,"The Multiple Traffic Lights and Warning label groups did not display any significant improvement in objective understanding either within or across food categories compared with the Reference Intakes group. ","[{'ForeName': 'Valentina A', 'Initials': 'VA', 'LastName': 'Andreeva', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Egnell', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Handjieva-Darlenska', 'Affiliation': 'Department of Pharmacology and Toxicology, Medical University, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Zenobia', 'Initials': 'Z', 'LastName': 'Talati', 'Affiliation': 'School of Psychology, Curtin University, Bentley, WA 6102 Australia.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Touvier', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Galan', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Hercberg', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'School of Psychology, Curtin University, Bentley, WA 6102 Australia.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Julia', 'Affiliation': 'Nutritional Epidemiology Research Group (EREN), Sorbonne Paris Nord University/INSERM U1153/INRAE U1125/CNAM), Epidemiology and Statistics Research Centre - University of Paris (CRESS), 74 rue Marcel Cachin, 93017 Bobigny, France.'}]",Archives of public health = Archives belges de sante publique,['10.1186/s13690-020-00416-z'] 2806,32528681,Dialectical behavior therapy adapted for binge eating compared to cognitive behavior therapy in obese adults with binge eating disorder: a controlled study.,"Background Current guidelines recommend cognitive behavior therapy (CBT) as the treatment of choice for binge eating disorder (BED). Although CBT is quite effective, a substantial number of patients do not reach abstinence from binge eating. To tackle this problem, various theoretical conceptualizations and treatment models have been proposed. Dialectical behavior therapy (DBT), focusing on emotion regulation, is one such model. Preliminary evidence comparing DBT adapted for BED (DBT-BED) to CBT is promising but the available data do not favor one treatment over the other. The aim of this study is to evaluate outcome of DBT-BED, compared to a more intensive eating disorders-focused form of cognitive behavior therapy (CBT+), in individuals with BED who are overweight and engage in emotional eating. Methods Seventy-four obese patients with BED who reported above average levels of emotional eating were quasi-randomly allocated to one of two manualized 20-session group treatments: DBT-BED ( n  = 41) or CBT+ ( n  = 33). Intention-to-treat outcome was examined at post-treatment and at 6-month follow-up using general or generalized linear models with multiple imputation. Results Overall, greater improvements were observed in CBT+. Differences in number of objective binge eating episodes at end of treatment, and eating disorder psychopathology (EDE-Q Global score) and self-esteem (EDI-3 Low Self-Esteem) at follow-up reached statistical significance with medium effect sizes (Cohen's d between .46 and .59). Of the patients in the DBT group, 69.9% reached clinically significant change at end of the treatment vs 65.0% at follow-up. Although higher, this was not significantly different from the patients in the CBT+ group (52.9% vs 45.8%). Conclusions The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures. Yet, regardless of the dose-difference, the data suggest that DBT-BED and CBT+ lead to comparable levels of clinically meaningful change in global eating disorder psychopathology. Future recommendations include the need for dose-matched comparisons in a sufficiently powered randomized controlled trial, and the need to determine mediators and moderators of treatment outcome. Trial registration Nederlands Trial Register: NL3982 (NTR4154). Date of registration: 2013 August 28, retrospectively registered.",2020,The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures.,"['obese adults with binge eating disorder', 'individuals with BED who are overweight and engage in emotional eating', 'Methods\n\n\nSeventy-four obese patients with BED who reported above average levels of emotional eating']","['cognitive behavior therapy', 'Dialectical behavior therapy (DBT', 'CBT', 'Dialectical behavior therapy', 'DBT', 'DBT-BED', 'cognitive behavior therapy (CBT']","['CBT', 'global eating disorder psychopathology', 'number of objective binge eating episodes', 'eating disorder psychopathology (EDE-Q Global score) and self-esteem (EDI-3 Low Self-Esteem']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1321145', 'cui_str': 'Dialectical behavior therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}]",74.0,0.0996041,The results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures.,"[{'ForeName': 'Mirjam W', 'Initials': 'MW', 'LastName': 'Lammers', 'Affiliation': 'Amarum, Expertise Centre for Eating Disorders, GGNet Network for Mental Health Care, Den Elterweg 75, 7207 AE Zutphen, The Netherlands.'}, {'ForeName': 'Maartje S', 'Initials': 'MS', 'LastName': 'Vroling', 'Affiliation': 'Amarum, Expertise Centre for Eating Disorders, GGNet Network for Mental Health Care, Den Elterweg 75, 7207 AE Zutphen, The Netherlands.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota USA.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'van Strien', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR Nijmegen, The Netherlands.'}]",Journal of eating disorders,['10.1186/s40337-020-00299-z'] 2807,32528722,Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial.,"Background It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having ""UF cycles"" using a higher glucose concentration, and ""Clearance cycles"" using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. Methods This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. Discussion The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies. Trial registration ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.",2020,"A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. ","['10 patients', 'Prevalent PD patients between 18 and 75\u2009years old without known catheter problems or recent peritonitis are eligible for inclusion', '20 patients have successfully completed the interventions or terminated according to interim analysis']",['standard APD'],"['ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine', 'glucose absorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1997821', 'cui_str': 'Automated peritoneal dialysis'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.0592087,"A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. ","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bergling', 'Affiliation': 'Division of Nephrology, Department of Clinical Sciences Lund, Lund University, Alwall House, Skåne University Hospital, Barngatan 2, 22185 Lund, Sweden.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de Arteaga', 'Affiliation': 'Servicio de Nefrología, Hospital Privado Universitario de Córdoba, Universidad Católica de Córdoba, Naciones Unidas 346, 5016 Córdoba, Argentina.'}, {'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Ledesma', 'Affiliation': 'Servicio de Nefrología, Hospital Privado Universitario de Córdoba, Universidad Católica de Córdoba, Naciones Unidas 346, 5016 Córdoba, Argentina.'}, {'ForeName': 'Carl Mikael', 'Initials': 'CM', 'LastName': 'Öberg', 'Affiliation': 'Division of Nephrology, Department of Clinical Sciences Lund, Lund University, Alwall House, Skåne University Hospital, Barngatan 2, 22185 Lund, Sweden.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00620-2'] 2808,32528810,Comparative Study Between Uniportal Full-Endoscopic Interlaminar and Tubular Approach in the Treatment of Lumbar Spinal Stenosis: A Pilot Study.,"Study Design Multicenter, prospective, randomized, and double-blinded study. Objectives To compare tubular and endoscopic interlaminar approach. Methods Patients with lumbar spinal stenosis and neurogenic claudication of were randomized to tubular or endoscopic technique. Enrollment period was 12 months. Clinical follow up at 1, 3, 6 months after surgery with visual analogue scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopedic Association (JOA) score. Radiologic evaluation with magnetic resonance pre- and postsurgery. Results Twenty patients were enrolled: 10 in tubular approach (12 levels) and 10 in endoscopic approach (11 levels). The percentage of enlargement of the spinal canal was higher in endoscopic approach (202%) compared with tubular approach (189%) but was not statistically significant ( P = .777). The enlargement of the dural sac was higher in endoscopic group (209%) compared with tubular group (203%) but no difference was found between the 2 groups ( P = .628). A modest significant correlation was found between the percentage of spinal canal decompression and enlargement of the dural sac ( r = 0.5, P = .023). Both groups reported a significant clinical improvement postsurgery. However, no significant association was found between the percentage of enlargement of the spinal canal or the dural sac and clinical improvement as determined by scales scores. Endoscopic group had lower intrasurgical bleeding ( P < .001) and lower disability at 6 months of follow-up than tubular group (p=0.037). Conclusions In the treatment of lumbar spinal stenosis, endoscopic technique allows similar decompression of the spinal canal and the dural sac, lower intrasurgical bleeding, similar symptoms improvement, and lower disability at 6 months of follow-up, as compared with the tubular technique.",2020,"Endoscopic group had lower intrasurgical bleeding ( P < .001) and lower disability at 6 months of follow-up than tubular group (p=0.037). ","['Lumbar Spinal Stenosis', 'Patients with lumbar spinal stenosis and neurogenic claudication', 'Twenty patients were enrolled: 10 in tubular approach (12 levels) and 10 in endoscopic approach (11 levels']","['Uniportal Full-Endoscopic Interlaminar and Tubular Approach', 'tubular or endoscopic technique', 'magnetic resonance pre- and postsurgery']","['enlargement of the dural sac', 'visual analogue scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopedic Association (JOA) score', 'lower disability', 'percentage of spinal canal decompression and enlargement of the dural sac', 'percentage of enlargement of the spinal canal or the dural sac and clinical improvement', 'percentage of enlargement of the spinal canal', 'intrasurgical bleeding']","[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",20.0,0.0366826,"Endoscopic group had lower intrasurgical bleeding ( P < .001) and lower disability at 6 months of follow-up than tubular group (p=0.037). ","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Carrascosa-Granada', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Willian', 'Initials': 'W', 'LastName': 'Velazquez', 'Affiliation': 'Hospital San Bernardo, Salta, Argentina.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Ligamenta Spine, Frankfurt, Germany.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Saab Mazzei', 'Affiliation': 'Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Vargas-Jimenez', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Jorquera', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Juan Antonio Barcia', 'Initials': 'JAB', 'LastName': 'Albacar', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Kita', 'Initials': 'K', 'LastName': 'Sallabanda', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}]",Global spine journal,['10.1177/2192568219878419'] 2809,32529103,"A double-blind, placebo-controlled clinical trial to assess the effects of a combined nutraceutical on endothelial function in patients with mild-to-moderate hypercholesterolaemia.","Introduction There is growing interest in lipid-lowering nutraceuticals; however, there are a relative scarcity of data on combined compounds. This study was aimed to assess the efficacy and tolerability of a combined nutraceutical (CARDIOL ® Forte - CF) containing polyunsaturated fatty acids, hydroxytyrosol, Coenzyme Q10, folic acid, B 12 and E vitamins, piperine, and red yeast rice in patients with mild-to-moderate hypercholesterolaemia. Material and methods In this single-centre, double-blinded, placebo-controlled study enrolled subjects who were randomised to receive the tested combined nutraceutical for 16 weeks (CF group) or placebo (control group), in association with a low-fat diet. After 8 weeks of treatment, all patients underwent a 15-day washout period; then, a further 8 weeks of treatment was planned. Results Of 80 enrolled subjects, 37 completed the study in the CF group and 38 in the control group. After 8 weeks of treatment, low-density lipoprotein cholesterol levels were reduced by 17% in the CF group and by 6.4% in the control group, compared to baseline ( p = 0.0001); these changes were improved at the end of study. Total cholesterol and triglyceride levels significantly decreased during treatment; high-density lipoprotein cholesterol did not change. In the CF group, flow-mediated dilation increased by 18.8% after 8 weeks and by 39.3% at the end of treatment. No adverse events or musculoskeletal disorders were reported in either group. Conclusions The tested combined nutraceutical, in association with a controlled diet, can reduce cholesterol levels and improve endothelial function, thus reducing the cardiovascular risk in patients with mild-to-moderate hypercholesterolaemia.",2020,"In the CF group, flow-mediated dilation increased by 18.8% after 8 weeks and by 39.3% at the end of treatment.","['patients with mild-to-moderate hypercholesterolaemia', '80 enrolled subjects']","['placebo (control group), in association with a low-fat diet', 'combined nutraceutical (CARDIOL ® Forte - CF) containing polyunsaturated fatty acids, hydroxytyrosol, Coenzyme Q10, folic acid, B 12 and E vitamins, piperine, and red yeast rice', 'placebo']","['low-density lipoprotein cholesterol levels', 'endothelial function', 'cardiovascular risk', 'adverse events or musculoskeletal disorders', 'cholesterol levels and improve endothelial function', 'efficacy and tolerability', 'flow-mediated dilation', 'Total cholesterol and triglyceride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0071112', 'cui_str': 'piperine'}, {'cui': 'C0763533', 'cui_str': 'red yeast rice'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",80.0,0.244927,"In the CF group, flow-mediated dilation increased by 18.8% after 8 weeks and by 39.3% at the end of treatment.","[{'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Pecchioli', 'Affiliation': 'Cardiovascular Prevention Unit, Hospital Department ASL Frosinone, Italy.'}, {'ForeName': 'Arrigo F G', 'Initials': 'AFG', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy.'}, {'ForeName': 'Nazareno', 'Initials': 'N', 'LastName': 'Lomartire', 'Affiliation': 'Anaesthesiology and Intensive Care Unit, ASL, Frosinone, Italy.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Gemmiti', 'Affiliation': 'Cardiology and Cardiological Intensive Care Unit, ASL Frosinone, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Colangeli', 'Affiliation': ""Pneumology Unit, Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Germanò', 'Affiliation': 'Policlinico Umberto I University ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Corsi', 'Affiliation': 'Cardiology and Cardiological Intensive Care Unit, ASL Frosinone, Italy.'}, {'ForeName': 'Giuseppe I W', 'Initials': 'GIW', 'LastName': 'Germanò', 'Affiliation': 'Policlinico Umberto I University ""La Sapienza"", Rome, Italy.'}]",Archives of medical sciences. Atherosclerotic diseases,['10.5114/amsad.2020.94986'] 2810,32529114,Can caffeine intake combined with aerobic exercise lead to improvement in attentional and psychomotor performance in trained individuals?,"To evaluate the acute effects of ingestion of 500 mg of caffeine in addition to aerobic exercise on the optimization of cognitive attention tasks and simple reaction time. Twenty men were randomly divided into two groups, caffeine (CAF) and placebo (PLA), and underwent cardiopulmonary exercise testing and cognitive testing (D2SLK, D2GZ, D2F% and TRS). Then, both ingested 500 mg of caffeine or placebo (double blind), and after 60 min performed a 30-minute continuous exercise session at 70 % VO2Max. Cognitive tests were repeated immediately after exercise, and after 30 min. D2SLK, D2GZ, D2F% and TRS scores were compared by repeated measures ANOVA. The magnitude of the effect was established, and it was considered meaningful p = 0.05. CAF is able to alter D2SLK and also reduce D2F% (0.001 - moderate effect, 0.82) and improve the task after 30 min of exercise (p = 0.014 - moderate effect 0.95). The TRS showed significant gains for the CAF group compared to PLA (0.000 - high effect 1.76). Caffeine induces significant effects in attention and reaction time domains independent of the effect of aerobic exercise.",2020,The TRS showed significant gains for the CAF group compared to PLA (0.000 - high effect 1.76).,['Twenty men'],"['caffeine (CAF) and placebo (PLA), and underwent cardiopulmonary exercise testing and cognitive testing (D2SLK, D2GZ, D2F% and TRS', 'caffeine', 'Caffeine', 'caffeine or placebo', 'CAF', 'aerobic exercise']","['Cognitive tests', 'attentional and psychomotor performance', 'cognitive attention tasks and simple reaction time', 'D2SLK, D2GZ, D2F% and TRS scores']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0266427', 'cui_str': 'Testicular regression syndrome'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0266427', 'cui_str': 'Testicular regression syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0922913,The TRS showed significant gains for the CAF group compared to PLA (0.000 - high effect 1.76).,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Physical Activity Neuroscience (LABNAF), Physical Activity Sciences Postgraduate Program of Salgado de Oliveira University (PPGCAF/UNIVERSO), Niterói, Brazil.'}, {'ForeName': 'Alberto Souza', 'Initials': 'AS', 'LastName': 'Sá Filho', 'Affiliation': 'Department of Physical Education - University Center of Anápolis (UniEVANGÉLICA), Anápolis, Goiás (GO), Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Campos', 'Affiliation': 'University of Porto, Porto, Portugal.'}, {'ForeName': 'Carolina Cavalcante', 'Initials': 'CC', 'LastName': 'de Paula', 'Affiliation': 'Department of Cellular, Tissue and Developmental Biology at the Institute of Biomedical Science at the University of São Paulo (ICB/USP), São Paulo, Brazil.'}, {'ForeName': 'Fabyana', 'Initials': 'F', 'LastName': 'Bernardes', 'Affiliation': 'Laboratory of Physical Activity Neuroscience (LABNAF), Physical Activity Sciences Postgraduate Program of Salgado de Oliveira University (PPGCAF/UNIVERSO), Niterói, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodriguez', 'Affiliation': 'Laboratorio de Neurociencias Moleculares e Integrativas Escuela de Medicina, División Ciencias de la Salud Universidad Anáhuac Mayab Mérida, Yucatán, Mexico.'}, {'ForeName': 'Geraldo A', 'Initials': 'GA', 'LastName': 'Maranhão Neto', 'Affiliation': 'Physical Activity Sciences Postgraduate Program of Salgado de Oliveira University (PPGCAF/UNIVERSO), Niterói, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lattari', 'Affiliation': 'Laboratory of Physical Activity Neuroscience (LABNAF), Physical Activity Sciences Postgraduate Program of Salgado de Oliveira University (PPGCAF/UNIVERSO), Niterói, Brazil.'}]",IBRO reports,['10.1016/j.ibror.2020.01.002'] 2811,32529175,Adjuvant doxycycline to enhance anti-amyloid effects: Results from the dual phase 2 trial.,"Background Although, doxycycline use is associated with improved outcomes in amyloidosis in retrospective studies, evidence from clinical trials is limited. Methods This phase 2 trial of doxycycline (clinicaltrials.gov: NCT02207556) in newly diagnosed light chain (AL) amyloidosis enrolled 25 patients with systemic AL amyloidosis on treatment with doxycycline for 1 year along with chemotherapy. Outcomes of interest included mortality, organ response, and hematologic response rates at 1 year. Findings The median age was 62 years, 64% were male, and 68% had the AL lambda subtype. Patients had Mayo 2012 stage 3 in 24% and stage 4 in 28%. Cardiac involvement was present in 60% of patients, renal involvement in 72%, and 60% patients had 3 or more organs involved. Target organ was cardiac in 14(56%), renal in 7(28%), hepatic in 1(4%) and soft tissue in 3(12%). At 1 year, mortality was 20% (95% confidence interval, 8.9-41.6%) and organ response was 36% (18-57%). Hematologic response in 1-year survivors was 100%, including 30% complete and 55% very good partial response. Autologous hematopoietic cell transplant was performed in 60%; among transplanted patients, day-100 transplant-related mortality was 0. Doxycycline use was safe and not attributed to any grade 2 or higher toxicity. Interpretation In addition to a low 1-year mortality, doxycycline use was safe and associated with high transplant utilization rate. We thus contend that doxycycline should be studied in a placebo-controlled study in newly diagnosed AL patients in the first year, particularly among patients with advanced disease and cardiac involvement.",2020,"In addition to a low 1-year mortality, doxycycline use was safe and associated with high transplant utilization rate.","['for 1 year along with chemotherapy', 'newly diagnosed light chain (AL) amyloidosis enrolled 25 patients with systemic AL amyloidosis on treatment with', 'The median age was 62 years, 64% were male, and 68% had the AL lambda subtype', 'Patients had Mayo 2012 stage 3 in 24% and stage 4 in 28', 'newly diagnosed AL patients in the first year, particularly among patients with advanced disease and cardiac involvement']","['doxycycline', 'Doxycycline', 'Adjuvant doxycycline', 'Autologous hematopoietic cell transplant']","['organ response', 'renal involvement', 'mortality', 'mortality, organ response, and hematologic response rates', 'Cardiac involvement', 'Hematologic response']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0268381', 'cui_str': 'AL amyloidosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",25.0,0.355594,"In addition to a low 1-year mortality, doxycycline use was safe and associated with high transplant utilization rate.","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': ""D'Souza"", 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Division of Biostatistics, Institute of Health and Safety, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Flynn', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}, {'ForeName': 'Binod', 'Initials': 'B', 'LastName': 'Dhakal', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Chhabra', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'Pasquini', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Weihrauch', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.'}, {'ForeName': 'Parameswaran N', 'Initials': 'PN', 'LastName': 'Hari', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, United States.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100361'] 2812,32529176,"Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study).","Background Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. Methods A total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks' treatment with basal insulin or premixed insulin administered either by a NFII or CIP. Trial registration ClinicalTrials.gov (NCT03243903). Findings In the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI -0.71, -0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI -0.42, -0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; p <0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. Interpretation Insulin therapy through needle-free injector showed a non-inferior glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile. Funding This study were funded by Beijing QS Medical Technology Co., Ltd, as well as The Major Chronic Non-communicable Disease Prevention and Control Research.",2020,"The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. ","['patients with T2DM', 'patients with type 2 diabetes mellitus (T2DM', '427 patients with T2DM', 'Chinese patients with type 2 diabetes mellitus']","['conventional insulin therapy', 'insulin treatment via a conventional insulin pen (CIP', 'insulin treatment via a needle-free insulin injector (NFII', 'Insulin delivery with a needle-free insulin injector versus a conventional insulin pen', 'basal insulin or premixed insulin administered either by a NFII or CIP', '\n\n\nInsulin therapy']","['HbA1c reduction', 'glucose-lowering effect, tolerability, patient satisfaction and compliance', 'skin scratches, indurations and lower VAS pain scores', 'occurrence of hypoglycemia', 'treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0487017', 'cui_str': 'Free insulin'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",427.0,0.0717354,"The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. ","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Endocrinology and Metabolism, Peking University Peoples Hospital, Beijing, China.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology and Metabolism, Peking University Peoples Hospital, Beijing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Metabolic Disease Hospital, Tianjin Medical University, Heping District, Tianjin, China.'}, {'ForeName': 'Yangang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Zhongshu', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology and Metabolism, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xingwu', 'Initials': 'X', 'LastName': 'Ran', 'Affiliation': 'Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zilin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Fuzhou General Hospital of Nanjing Command, Fujian Province, China.'}, {'ForeName': 'Guixia', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The First Hospital of Jilin University, Changchun, Jilin Province, China.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of China Medical University, Shenyang, China.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100368'] 2813,32533427,"Intravenous regular insulin is an efficient and safe procedure for obtaining high-quality cardiac 18 F-FDG PET images: an open-label, single-center, randomized controlled prospective trial.","BACKGROUND An open-label, single-center, randomized controlled prospective trial was performed to assess the efficiency and safety of an insulin loading procedure to obtain high-quality cardiac 18 F-FDG PET/CT images for patients with coronary artery disease (CAD). METHODS Between November 22, 2018 and August 15, 2019, 60 patients with CAD scheduled for cardiac 18 F-FDG PET/CT imaging in our department were randomly allocated in a 1:1 ratio to receive an insulin or standardized glucose loading procedure for cardiac 18 F-FDG imaging. The primary outcome was the ratio of interpretable images (high-quality images defined as myocardium-to-liver ratios ≥ 1). The secondary outcome was the patient preparation time (time interval between administration of insulin/glucose and 18 F-FDG injection). Hypoglycemia events were recorded. RESULTS The ratio of interpretable cardiac PET images in the insulin loading group surpassed the glucose loading group (30/30 vs. 25/30, P = 0.026). Preparation time was 71±2 min shorter for the insulin loading group than for the glucose loading group (P < 0.01). Two and six hypoglycemia cases occurred in the insulin and glucose loading groups, respectively. CONCLUSION The insulin loading protocol was a quicker, more efficient, and safer preparation for gaining high-quality cardiac 18 F-FDG images.",2020,Preparation time was 71±2 min shorter for the insulin loading group than for the glucose loading group (P < 0.01).,"['Between November 22, 2018 and August 15, 2019', '60 patients with CAD scheduled for cardiac 18 F-FDG PET/CT imaging in our department', 'patients with coronary artery disease (CAD']","['Intravenous regular insulin', 'insulin or standardized glucose loading procedure for cardiac 18 F-FDG imaging', 'insulin loading procedure to obtain high-quality cardiac 18 F-FDG PET/CT images']","['ratio of interpretable cardiac PET images', 'efficiency and safety', 'Hypoglycemia events', 'patient preparation time (time interval between administration of insulin/glucose and 18 F-FDG injection', 'ratio of interpretable images (high-quality images defined as myocardium-to-liver ratios ≥ 1', 'Preparation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0582431', 'cui_str': 'Preparation of patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}]",60.0,0.125642,Preparation time was 71±2 min shorter for the insulin loading group than for the glucose loading group (P < 0.01).,"[{'ForeName': 'Yang Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Nuclear Medicine, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China. fudanzhsh@ymail.com.'}, {'ForeName': 'Qing Qing', 'Initials': 'QQ', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China.'}, {'ForeName': 'Yue Hui', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China.'}, {'ForeName': 'Hui Lin', 'Initials': 'HL', 'LastName': 'Zhuo', 'Affiliation': 'Department of Cardiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China.'}, {'ForeName': 'Ruo Zhu', 'Initials': 'RZ', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-020-02219-9'] 2814,32533519,Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty.,"BACKGROUND AND OBJECTIVES Opioids are associated with sedation and respiratory depression. The primary objective of this study was to assess pain intensity after gastric bypass with lidocaine. The secondary objective was to assess the IL-6 concentration, consumption of morphine, time to morphine request, time to extubation, and side effects. METHODS Sixty patients aged 18 to 60 years, with ASA (American Society of Anesthesiologists) scores of 2 or 3, who underwent bariatric surgery were allocated to two groups. Patients in group 1 were administered lidocaine (1.5 mg/kg) 5 min before the induction of anesthesia, and group 2 was administered 0.9% saline solution in an equal volume. Subsequently, lidocaine (2 mg/kg/h) or 0.9% saline was infused during the entire surgical procedure. Anesthesia was performed with fentanyl (5 μg/kg), propofol, rocuronium, and sevoflurane. Postoperative patient-controlled analgesia was provided with morphine. The following were evaluated: pain intensity, IL-6, 24-h consumption of morphine, time to the morphine request, time to extubation, and adverse effects. RESULTS The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation. The lidocaine group consumed less morphine within 24 h, had a longer time until the first supplemental morphine request, and had a lower incidence of nausea. CONCLUSIONS Lidocaine reduced the intensity of early postoperative pain, incidence of nausea, and consumption of morphine within 24 h and increased time to the first morphine request, without reducing the plasma concentrations of IL-6.",2020,"The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation.","['Sixty patients aged 18 to 60\xa0years, with ASA (American Society of Anesthesiologists) scores of 2 or 3, who underwent bariatric surgery']","['Lidocaine', 'lidocaine', 'fentanyl', 'propofol, rocuronium, and sevoflurane', 'Perioperative Venous Lidocaine', 'morphine']","['IL-6 concentration, consumption of morphine, time to morphine request, time to extubation, and side effects', 'intensity of early postoperative pain, incidence of nausea, and consumption of morphine', 'pain intensity', 'Intensity of Pain and IL-6 Concentration', 'plasma concentrations of IL-6', 'nausea', 'IL-6 and time to extubation', 'pain intensity, IL-6, 24-h consumption of morphine, time to the morphine request, time to extubation, and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",60.0,0.170427,"The lidocaine group had a lower pain intensity than the saline group for up to 1 h, with no differences between groups in IL-6 and time to extubation.","[{'ForeName': 'Caio Marcio Barros', 'Initials': 'CMB', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Lais Maria Gaspar', 'Initials': 'LMG', 'LastName': 'Coelho', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'José Aparecido', 'Initials': 'JA', 'LastName': 'Valadão', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Ed Carlos Rey', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Antônio Augusto Moura', 'Initials': 'AAM', 'LastName': 'da Silva', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Roclides Castro', 'Initials': 'RC', 'LastName': 'de Lima', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Milena Karina Coló', 'Initials': 'MKC', 'LastName': 'Brunialti', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil.'}, {'ForeName': 'Reinaldo', 'Initials': 'R', 'LastName': 'Salomão', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil.'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'da Cunha Leal', 'Affiliation': 'Universidade Federal do Maranhão, São Luís, Brazil.'}, {'ForeName': 'Rioko Kimiko', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Universidade Federal de São Paulo, Rua Botucatu 593, São Paulo, 04023-900, Brazil. rsakata@unifesp.br.'}]",Obesity surgery,['10.1007/s11695-020-04748-1'] 2815,32533536,Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies.,"BACKGROUND Cognitive impairment is a core feature of schizophrenia. While first- and second-generation antipsychotic drugs treat psychotic exacerbations, no treatment is approved for the cognitive dysfunction. We have identified ASP4345, a positive allosteric modulator of the dopamine type 1 (D 1 ) receptor that selectively binds to, and enhances the activity of, D 1 receptors. ASP4345 has the potential to be an effective and well-tolerated treatment option for cognitive impairment associated with schizophrenia. OBJECTIVE The objective of this study was to determine the pharmacokinetics of ASP4345 in two phase I single ascending-dose and multiple ascending-dose studies. METHODS Both phase I studies were randomized, double blind, and placebo controlled. The single dose-ascending study assessed pharmacokinetics of single oral doses of 3-900 mg of ASP4345 or placebo in the fasted state in healthy adult volunteers. This study also assessed cerebrospinal fluid pharmacokinetics, as well as the effects of food on pharmacokinetic parameters. The multiple ascending-dose study (NCT02720263) assessed the pharmacokinetics of multiple oral doses of 3-150 mg of ASP4345 in patients with schizophrenia or schizoaffective disorder receiving stable antipsychotic drug treatment. The pharmacokinetic data from both studies were summarized using descriptive statistics. RESULTS The plasma concentration-time profile in both studies showed a rapid increase in concentrations of ASP4345. The median time to maximum concentration range was 1.00-2.26 h in the single ascending-dose study in the fasted state and 1.25-3.02 h in the multiple ascending-dose study at steady state. There were less than dose-proportional increases in maximum concentration and area under the curve in the single ascending-dose study, where doses had a range from 3 to 900 mg, and in the multiple ascending-dose study in patients with stabilized schizophrenia or schizoaffective disorder, where doses had a range from 3 to 150 mg. The mean terminal elimination half-life was dose independent and had a range from 9.12 to 14.3 h in the single ascending-dose study and from 11.1 to 26.8 h in the multiple ascending-dose study. Additionally, in the single ascending-dose study, absorption of 300 mg of ASP4345 was slightly delayed when administered in the fed state compared with the fasted state; median time to maximum concentration was 1.5 h under the fasting state and 4.0 h under fed states. All other pharmacokinetic parameters were comparable for both conditions. ASP4345 appeared in the cerebrospinal fluid with some delay; time to maximum concentration range was from 2.48 to 7.98 h in cerebrospinal fluid compared with 0.75 to 1.03 h in plasma (median cerebrospinal fluid/plasma = 0.188). The ratio of cerebrospinal fluid to total plasma for area under the curve from 0 to 24 h (0.157-0.573%) and maximum concentration (0.0899-0.311%) and the ratio of cerebrospinal fluid to unbound plasma for maximum concentration (25.0-86.4%) confirm the distribution of ASP4345 into the brain. CONCLUSIONS The pharmacokinetics of ASP4345 suggest that single daily dosing is appropriate for ASP4345. Furthermore, the concentration of ASP4345 in cerebrospinal fluid compared to free drug concentrations in plasma provides evidence of penetration of ASP4345 into the brain.",2020,"There were less than dose-proportional increases in maximum concentration and area under the curve in the single ascending-dose study, where doses had a range from 3 to 900 mg, and in the multiple ascending-dose study in patients with stabilized schizophrenia or schizoaffective disorder, where doses had a range from 3 to 150 mg.","['healthy adult volunteers', 'patients with schizophrenia or schizoaffective disorder receiving stable antipsychotic drug treatment', 'patients with stabilized schizophrenia or schizoaffective disorder']","['ASP4345 or placebo', 'ASP4345', 'placebo']","['plasma concentration-time profile', 'concentrations of ASP4345', 'median time to maximum concentration range', 'cerebrospinal fluid with some delay; time to maximum concentration range', 'ratio of cerebrospinal fluid to total plasma for area under the curve', 'mean terminal elimination half-life', 'maximum concentration', 'maximum concentration and area under the curve', 'ratio of cerebrospinal fluid to unbound plasma for maximum concentration']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",,0.0954897,"There were less than dose-proportional increases in maximum concentration and area under the curve in the single ascending-dose study, where doses had a range from 3 to 900 mg, and in the multiple ascending-dose study in patients with stabilized schizophrenia or schizoaffective disorder, where doses had a range from 3 to 150 mg.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA. amit.desai@astellas.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Ruishan', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Gertsik', 'Affiliation': 'California Clinical Trials Medical Group, Inc., Glendale, CA, USA.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Uz', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Marek', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00911-0'] 2816,32533548,The Effectiveness of Acceptance and Commitment Therapy on Pain Acceptance and Pain Perception in Patients with Painful Diabetic Neuropathy: A Randomized Controlled Trial.,"INTRODUCTION Neuropathic pain is a complex phenomenon in patients with diabetes. These patients have many problems, such as psychological problems, high-level pain perception, and pain acceptance. This study aimed to evaluate the effectiveness of acceptance and commitment therapy on pain acceptance and pain perception in patients with painful diabetic neuropathy. METHODS This study was performed according to the clinical trial method. The sample size was 50 participants. In this study, participants were divided into interventional and control groups. According to the diagnosis of neurologists, all participants received conventional medications to manage neuropathic pain. The intervention group received acceptance and commitment therapy for eight sessions. The results in the three phases of pre-test, post-test, and follow-up were evaluated. After completing the study, to comply with ethical standards, the control group received psycho-education. The tools used were the McGill Pain Questionnaire (MPQ) and the Chronic Pain Acceptance Questionnaire (CPAQ). Statistical analysis includes mean, standard deviation, and repeated-measures (ANOVA) conducted by SPSS software version 22. RESULTS The results demonstrated that in the post-test and follow-up phases, acceptance and commitment therapy could improve pain acceptance and reduce pain perception in the intervention group compared to the control group (P < 0.01). CONCLUSION The results indicated that acceptance and commitment therapy could be used as a psychological intervention besides pharmacotherapy to improve pain acceptance and reduce pain perception in patients with painful diabetic neuropathy. CLINICAL TRAIL REGISTRATION This study was registered at the Iranian Registry of Clinical Trials (IRCT20180205038630N4).",2020,"The results demonstrated that in the post-test and follow-up phases, acceptance and commitment therapy could improve pain acceptance and reduce pain perception in the intervention group compared to the control group (P < 0.01). ","['patients with diabetes', 'Patients with Painful Diabetic Neuropathy', 'patients with painful diabetic neuropathy']","['psycho-education', 'acceptance and commitment therapy', 'conventional medications', 'Acceptance and Commitment Therapy']","['pain acceptance and reduce pain perception', 'Pain Acceptance and Pain Perception', 'McGill Pain Questionnaire (MPQ) and the Chronic Pain Acceptance Questionnaire (CPAQ', 'pain\xa0acceptance and pain perception']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0546189,"The results demonstrated that in the post-test and follow-up phases, acceptance and commitment therapy could improve pain acceptance and reduce pain perception in the intervention group compared to the control group (P < 0.01). ","[{'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Taheri', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran. aliakbar.Foroughi@kums.ac.ir.'}, {'ForeName': 'Youkhabeh', 'Initials': 'Y', 'LastName': 'Mohammadian', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Heshmati', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Leila Afshar', 'Initials': 'LA', 'LastName': 'Hezarkhani', 'Affiliation': 'Department of Neurology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Parvizifard', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00851-9'] 2817,32533797,Comparison of a Web-Push survey research protocol with a mailed paper and pencil protocol in the 'Monitoring the Future' Panel Survey.,"AIMS The experiment tested the effects of a Web-Push survey research protocol, compared with the standard mailed paper and pencil protocol, among young adults aged 19 to 30 in the 'Monitoring the Future' (MTF) longitudinal study. DESIGN, SETTING & PARTICIPANTS The U.S.-based MTF study has measured substance use trends among young adults in panel samples followed biennially, using consistent mailed survey procedures from 1977 to 2017. In 2018, young adult participants in the MTF longitudinal component scheduled to be surveyed at ages 19-30 in 2018 (from high school senior cohorts of 2006-2017, N=14,709) were randomly assigned to receive the standard mail/paper survey procedures or new Web-Push procedures. MEASUREMENTS Primary outcomes were responding to the survey and prevalence estimates for past 30-day use of alcohol, cigarettes, marijuana, and illicit drugs. FINDINGS The Web-Push response rate was 39.07% (95% CI=37.889, 40.258); this was significantly better than the standard MTF response rate of 35.12% (95% CI=33.964, 36.285). After adjusting for covariates, the Web-Push condition was associated with a 19% increase in the odds of responding compared with standard MTF (AOR=1.188; 95% CI=1.096, 1.287). Substance use prevalence estimates were very similar and differences became negligible when using attrition weights and controlling for sociodemographic characteristics. CONCLUSIONS The Web-Push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future (MTF) panel study, without substantially affecting estimates of substance use once attrition weights and sociodemographic variables were factored in.",2020,"The Web-Push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future (MTF) panel study, without substantially affecting estimates of substance use once attrition weights and sociodemographic variables were factored in.","['In 2018, young adult participants in the MTF longitudinal component scheduled to be surveyed at ages 19-30 in 2018 (from high school senior cohorts of 2006-2017, N=14,709', 'young adults in panel samples followed biennially, using consistent mailed survey procedures from 1977 to 2017', ""young adults aged 19 to 30 in the 'Monitoring the Future' (MTF) longitudinal study""]",['standard mail/paper survey procedures or new Web-Push procedures'],"['Web-Push response rate', 'responding to the survey and prevalence estimates for past 30-day use of alcohol, cigarettes, marijuana, and illicit drugs', 'response rate', 'standard MTF response rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0580841', 'cui_str': 'Does push'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",14709.0,0.0644472,"The Web-Push protocol produced a higher response rate than the mailed pencil and paper protocol in the Monitoring the Future (MTF) panel study, without substantially affecting estimates of substance use once attrition weights and sociodemographic variables were factored in.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN, 55415, USA.""}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI, 48106, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Parks', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN, 55415, USA.""}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Laetz', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI, 48106, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Schulenberg', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI, 48106, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15158'] 2818,32533796,Attachment & Child Health (ATTACH) pilot trials: Effect of parental reflective function intervention for families affected by toxic stress.,"Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment. Parental reflective function-parents' capacity to understand their own and their child's mental states and thus regulate their own feelings and behavior toward their child-may buffer the negative effects of toxic stress on attachment. Our objective was to test the effectiveness of the Attachment and Child Health (ATTACH) intervention, focusing on improving reflective function and children's attachment security, for at-risk mothers and children <36 months of age. Three pilot studies were conducted with women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter. Randomized control trial (n = 20, n = 10 at enrollment) and quasi-experimental (n = 10 at enrollment) methods tested the effect of the ATTACH intervention on the primary outcome of reflective function scores, from transcribed Parent Development Interviews. Our secondary outcome was children's attachment patterns from Ainsworth's Strange Situation Procedure. Despite some attrition, mixed methods analysis of covariance and t tests revealed significant differences in maternal, child, and overall reflective function, with moderate effect sizes. While more children whose mothers received the ATTACH program were securely attached posttreatment, as compared with controls, significant differences were not observed, which may be due to missing observations (n = 5 cases). Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.",2020,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"['risk mothers and children <36 months of age', 'families affected by toxic stress', 'women and children from an inner city agency serving vulnerable, low-income families and a family violence shelter']","['parental reflective function intervention', 'ATTACH intervention', 'Attachment and Child Health (ATTACH) intervention']","['Toxic stressors (e.g., parental violence, depression, low income) place children at risk for insecure attachment']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0206072', 'cui_str': 'Family Violence'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0582758', 'cui_str': 'Insecure attachment'}]",,0.0662825,Understanding the effectiveness of programs like the ATTACH intervention contributes to improved programs and services to promote healthy development of children affected by toxic stress.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Letourneau', 'Affiliation': 'Faculty of Nursing and Cumming School of Medicine, Departments of Pediatrics, Psychiatry, & Community Health Sciences, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Anis', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ntanda', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Novick', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Steele', 'Affiliation': 'Department of Psychology, The New School, New York City, NY, 1011.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Hart', 'Affiliation': ""Owerko Centre at the Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada, T2N 1N4.""}]",Infant mental health journal,['10.1002/imhj.21833'] 2819,32533800,Building consensus: thresholds for delivery in the TRUFFLE 2 randomized intervention study.,,2020,,[],[],[],[],[],[],,0.0379308,,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mylrea-Foley', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhide', 'Affiliation': ""Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust and Molecular & Clinical Sciences Research Institute, St George's University, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mullins', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'School of Clinical Sciences, University of Nottingham, Division of Obstetrics and Gynaecology, Maternity Department, City Hospital, Nottingham, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Marlow', 'Affiliation': ""Academic Neonatology, UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Stampalija', 'Affiliation': 'Unit of Fetal Medicine and Prenatal Diagnosis, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Napolitano', 'Affiliation': 'Fetal Medicine Unit, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lees', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.22124'] 2820,31167875,Comprehensive ascertainment of bleeding in patients prescribed different combinations of dual antiplatelet therapy (DAPT) and triple therapy (TT) in the UK: study protocol for three population-based cohort studies emulating 'target trials' (the ADAPTT Study).,"INTRODUCTION 'Real world' bleeding in patients exposed to different regimens of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) have a clinical and economic impact but have not been previously quantified. METHODS AND ANALYSIS We will use linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data to assemble populations eligible for three 'target trials' in patient groups: percutaneous coronary intervention (PCI); coronary artery bypass grafting (CABG); conservatively managed (medication only) acute coronary syndrome (ACS). Patients ≥18 years old will be eligible if, in CPRD records, they have: ≥1 year of data before the index event; no prescription for DAPT or anticoagulants in the preceding 3 months; a prescription for aspirin or DAPT within 2 months after discharge from the index event. The primary outcome will be any bleeding event (CPRD or HES) up to 12 months after the index event. We will estimate adjusted HR for time to first bleeding event comparing: aspirin and clopidogrel (reference) versus aspirin and prasugrel or aspirin and ticagrelor after PCI; and aspirin (reference) versus aspirin and clopidogrel after CABG and ACS. We will describe rates of bleeding in patients prescribed TT (DAPT plus an anticoagulant). Potential confounders will be identified systematically using literature review, semistructured interviews with clinicians and a short survey of clinicians. We will conduct sensitivity analyses addressing the robustness of results to the study's main limitation-that we will not be able to identify the intervention group for patients whose bleeding event occurs before a DAPT prescription in CPRD. ETHICS AND DISSEMINATION This protocol was approved by the Independent Scientific Advisory Committee for the UK Medicines and Healthcare Products Regulatory Agency Database Research (protocol 16_126R) and the South West Cornwall and Plymouth Research Ethics Committee (17/SW/0092). The findings will be presented in peer-reviewed journals, lay summaries and briefing papers to commissioners/other stakeholders. TRIAL REGISTRATION NUMBER 76607611; Pre-results.",2019,We will estimate adjusted HR for time to first bleeding event comparing: aspirin and clopidogrel (reference) versus aspirin and prasugrel or aspirin and ticagrelor after PCI; and aspirin (reference) versus aspirin and clopidogrel after CABG and ACS.,"['Patients ≥18 years old will be eligible if, in CPRD records, they have: ≥1\u2009year of data before the index event; no prescription for DAPT or anticoagulants in the preceding 3\u2009months; a prescription for aspirin or DAPT within 2\u2009months after discharge from the index event', 'only) acute coronary syndrome (ACS']","['dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant', 'percutaneous coronary intervention (PCI); coronary artery bypass grafting (CABG); conservatively managed (medication', 'dual antiplatelet therapy (DAPT) and triple therapy (TT', 'TT (DAPT plus an anticoagulant', 'aspirin (reference) versus aspirin and clopidogrel', 'aspirin and clopidogrel (reference) versus aspirin and prasugrel or aspirin and ticagrelor']",['bleeding event (CPRD or HES'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",,0.104314,We will estimate adjusted HR for time to first bleeding event comparing: aspirin and clopidogrel (reference) versus aspirin and prasugrel or aspirin and ticagrelor after PCI; and aspirin (reference) versus aspirin and clopidogrel after CABG and ACS.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pufulete', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'NIHR Biomedical Research Centre, Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Johnson', 'Affiliation': 'Department of Cardiology, Bristol Heart Institute, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasserson', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mumford', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford UK.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Yoon', 'Initials': 'Y', 'LastName': 'Loke', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Christalla', 'Initials': 'C', 'LastName': 'Pithara', 'Affiliation': 'Ethnography Research Team, National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), Bristol, UK.'}, {'ForeName': 'Sabi', 'Initials': 'S', 'LastName': 'Redwood', 'Affiliation': 'Ethnography Research Team, National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), Bristol, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029388'] 2821,31480866,Impact of disease risk on the narrative bias in vaccination risk perceptions.,"Objective: Previous studies have shown that even when a statistical base-rate of vaccine adverse events (VAE) is provided, a small sample of single-case narratives influences vaccination risk perceptions and vaccination intentions, irrespective of various content characteristics. This study investigated whether this narrative bias is moderated by an environmental feature, namely the risk of the disease. Design: In three online-experiments, 564 subjects were presented with statistical information (20%) about the probability of VAE associated with a hypothetical vaccination and with a sample of narratives describing personal vaccination experiences. The relative frequency of narratives reporting VAE was varied between-subjects (5/20/35%) to test for a bias. Three potential moderators were tested: likelihood of infection, severity of disease and perceived susceptibility to the disease. Main outcome measures: Perceived risk of vaccination and intention to get vaccinated. Results: Compared to the control condition (20%), narratives reporting VAE increased (35%) and decreased (5%) risk perceptions, which affected vaccination intentions respectively. This bias was not affected by any variable pertaining to the disease risk. Conclusion: People's vaccination decisions are reliably affected by small samples of single-case vaccination experiences. As this influence works in either direction, health communicators should provide people with many examples of safely completed vaccinations.",2020,"Compared to the control condition (20%), narratives reporting VAE increased (35%) and decreased (5%) risk perceptions, which affected vaccination intentions respectively.",['564 subjects were presented with statistical information (20%) about the probability of VAE associated with a hypothetical vaccination and with a sample of narratives describing personal vaccination experiences'],[],"['relative frequency of narratives reporting VAE', 'risk of vaccination and intention to get vaccinated', 'narratives reporting VAE']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",564.0,0.0605221,"Compared to the control condition (20%), narratives reporting VAE increased (35%) and decreased (5%) risk perceptions, which affected vaccination intentions respectively.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Haase', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Department of Media and Communication Science, University of Erfurt, Erfurt, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Betsch', 'Affiliation': 'Department of Media and Communication Science, University of Erfurt, Erfurt, Germany.'}]",Psychology & health,['10.1080/08870446.2019.1630561'] 2822,32528966,"Acute Effect of Transcutaneous Electroacupuncture on Globus Pharyngeus: A Randomized, Single-Blind, Crossover Trial.","Background: Acupuncture points are commonly used by Traditional Chinese Medicine to treat throat discomfort. Transcutaneous electroacupuncture (TEA) is a new therapy combining transcutaneous electrical nerve stimulation with meridian theory. The efficacy and mechanism of Transcutaneous electroacupuncture for globus pharyngeus has not been reported. The aim of our study was to explore the effect and possible mechanisms of TEA at CV22/LI3/LU11/ST36 for patients with globus. Methods: A total of 80 patients with globus pharyngeus were randomly allocated into eight groups. The intervention order in Groups A1/B1/C1/D1 was firstly TEA at CV22/LI3/LU11/ST36 during the first period and sham-TEA in the second period. For participants in Groups A2/B2/C2/D2, the intervention order was the reverse. Before the test, the participants were asked to complete the Glasgow Edinburgh Throat Scale (GETS), visual analog scale (VAS), and the Hamilton Rating Scale Anxiety/Depression and were then asked to test and measure the heart rate variability and serum hormone levels of SP and NPY. At the end of the second period, these tests were manipulated again. Results: D-values of GETS and VAS following stimulation at CV22/LU11 were significantly higher than those of sham-stimulating (CV22: 13.5 ± 13.09 vs. 1 ± 9.68, P <0.002; LU11: 17 ± 10.31 vs. 9 ± 9.68, P = 0.011). Heart rate variability, SP, and NPY were showed a significant difference in LU11 stimulation compared to other acupuncture points ( P all <0.05). Conclusion: Stimulation at CV22/LU11 significantly improved symptoms of globus. The results indicated that symptoms may be improved by stimulating the parasympathetic nervous system and secreting SP and NPY when stimulating at LU11. For CV22, it may improve symptoms by direct action on the throat. Stimulating at CV22/LU11 may be a potential therapy for treating globus.",2020,"Heart rate variability, SP, and NPY were showed a significant difference in LU11 stimulation compared to other acupuncture points ( P all <0.05). ","['patients with globus', 'Globus Pharyngeus', '80 patients with globus pharyngeus']","['TEA at CV22/LI3/LU11/ST36', 'Transcutaneous electroacupuncture (TEA', 'Transcutaneous electroacupuncture', 'CV22/LU11', 'Transcutaneous Electroacupuncture']","['Heart rate variability, SP, and NPY', 'Glasgow Edinburgh Throat Scale (GETS), visual analog scale (VAS), and the Hamilton Rating Scale Anxiety/Depression', 'symptoms of globus', 'heart rate variability and serum hormone levels of SP and NPY', 'LU11 stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017650', 'cui_str': 'Feeling of lump in throat'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0450475', 'cui_str': 'LU11'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",80.0,0.0332694,"Heart rate variability, SP, and NPY were showed a significant difference in LU11 stimulation compared to other acupuncture points ( P all <0.05). ","[{'ForeName': 'Wencong', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Hanbing', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Guoyuan', 'Initials': 'G', 'LastName': 'Dou', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Wanwei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}]",Frontiers in medicine,['10.3389/fmed.2020.00179'] 2823,32528991,Mulligan Knee Taping Using Both Elastic and Rigid Tape Reduces Pain and Alters Lower Limb Biomechanics in Female Patients With Patellofemoral Pain.,"Background Evidence supports the use of Mulligan knee taping in managing patellofemoral pain (PFP). However, no studies have compared the efficacy of rigid and elastic tape using this technique. Hypothesis Mulligan knee taping applied with both rigid and elastic tape will produce similar reductions in knee pain, hip internal rotation, and knee flexion moments compared with no tape. Elastic tape will also be more comfortable than rigid tape. Study Design Controlled laboratory study. Methods A total of 19 female patients (mean age, 26.5 ± 4.5 years) with PFP performed a self-selected pain provocative task, single-leg squat (SLSq) task, and running task while wearing Mulligan knee taping applied with rigid tape, elastic tape at 100% tension, and no tape. Pain and taping comfort were recorded using 11-point numeric rating scales. An 18-camera motion capture system and in-ground force plates recorded 3-dimensional lower limb kinematics and kinetics for the SLSq and running tasks. Statistical analysis involved a series of repeated-measures analyses of variance. The Wilcoxon signed rank test was used for analyzing taping comfort. Results Compared with no tape, both rigid and elastic tape significantly reduced pain during the pain provocative task (mean difference [MD], -0.97 [95% CI, -1.57 to -0.38] and -1.42 [95% CI, -2.20 to -0.64], respectively), SLSq (MD, -1.26 [95% CI, -2.23 to -0.30] and -1.13 [95% CI, -2.09 to -0.17], respectively), and running tasks (MD, -1.24 [95% CI, -2.11 to -0.37] and -1.16 [95% CI, -1.86 to -0.46], respectively). Elastic tape was significantly more comfortable than rigid tape generally ( P = .005) and during activity ( P = .022). Compared with no tape, both rigid and elastic tape produced increased knee internal rotation at initial contact during the running task (MD, 5.5° [95% CI, 3.6° to 7.4°] and 5.9° [95% CI, 3.9° to 7.9°], respectively) and at the commencement of knee flexion during the SLSq task (MD, 5.8° [95% CI, 4.5° to 7.0°] and 5.8° [95% CI, 4.1° to 7.4°], respectively), greater peak knee internal rotation during the running (MD, 1.8° [95% CI, 0.4° to 3.3°] and 2.2° [95% CI, 0.9° to 3.6°], respectively) and SLSq tasks (MD, 3.2° [95% CI, 2.1° to 4.3°] and 3.8° [95% CI, 2.3° to 5.2°], respectively), and decreased knee internal rotation range of motion during the running (MD, -3.6° [95% CI, -6.1° to -1.1°] and -3.7° [95% CI, -6.2° to -1.2°], respectively) and SLSq tasks (MD, -2.5° [95% CI, -3.9° to -1.2°] and -2.0° [95% CI, -3.2° to -0.9°], respectively). Conclusion Mulligan knee taping with both rigid and elastic tape reduced pain across all 3 tasks and altered tibiofemoral rotation during the SLSq and running tasks. Clinical Relevance Both taping methods reduced pain and altered lower limb biomechanics. Elastic tape may be chosen clinically for comfort reasons.",2020,"Compared with no tape, both rigid and elastic tape significantly reduced pain during the pain provocative task (mean difference [MD], -0.97","['Female Patients With Patellofemoral Pain', '19 female patients (mean age, 26.5 ± 4.5 years) with PFP performed a self-selected pain provocative task']","['Mulligan knee taping', 'Elastic tape', 'single-leg squat (SLSq) task, and running task while wearing Mulligan knee taping applied with rigid tape, elastic tape at 100% tension, and no tape', 'rigid and elastic tape', 'Mulligan knee taping with both rigid and elastic tape', 'Mulligan Knee Taping Using Both Elastic and Rigid Tape']","['pain across all 3 tasks and altered tibiofemoral rotation', 'Elastic tape', 'Pain and taping comfort', 'Pain and Alters Lower Limb Biomechanics', '11-point numeric rating scales', 'pain during the pain provocative task', 'knee pain, hip internal rotation, and knee flexion moments', 'knee internal rotation', 'knee internal rotation range of motion', 'pain and altered lower limb biomechanics', 'peak knee internal rotation', 'SLSq tasks']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",19.0,0.151674,"Compared with no tape, both rigid and elastic tape significantly reduced pain during the pain provocative task (mean difference [MD], -0.97","[{'ForeName': 'Grant J K', 'Initials': 'GJK', 'LastName': 'Mackay', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Stearne', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Catherine Y', 'Initials': 'CY', 'LastName': 'Wild', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Erin P', 'Initials': 'EP', 'LastName': 'Nugent', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Murdock', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mastaglia', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120921673'] 2824,32528994,Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial.,"Background Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design Randomized controlled trial; Level of evidence, 1. Methods Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm 2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales-Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life-at 54 and 108 weeks after treatment. Conclusion This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration EUCTR2011-003594-28-DE (EU Clinical Trials Register).",2020,"Both groups showed significant improvement in 4 KOOS subscales-Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life-at 54 and 108 weeks after treatment. ","['Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm 2 in the weightbearing area of the femoral condyles with indication for MF were included in this study', 'Local Cartilage Defects of the Femoral Condyles']","['Hyaluronan vs Microfracture', 'polyglycolic acid and hyaluronan', 'polyglycolic acid matrix with hyaluronan with MF', 'MF or m-BMS with Chondrotissue', 'Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane', '\n\n\nMicrofracture (MF']","['clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey', '4 KOOS subscales-Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life', 'cartilage repair tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1265651', 'cui_str': 'Microfracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C1265651', 'cui_str': 'Microfracture'}, {'cui': 'C0032502', 'cui_str': 'Polyglycolide'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.199827,"Both groups showed significant improvement in 4 KOOS subscales-Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life-at 54 and 108 weeks after treatment. ","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Glasbrenner', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Wolf', 'Initials': 'W', 'LastName': 'Petersen', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Martin Luther Hospital Berlin, Berlin, Germany.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Steiger', 'Affiliation': 'Institute of Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Verdonk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Claudio C', 'Initials': 'CC', 'LastName': 'Castelli', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, ASST Papa Giovanni XXIII Bergamo, Bergamo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Zappalà', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, ASST Papa Giovanni XXIII Bergamo, Bergamo, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fritschy', 'Affiliation': 'Department of Orthopedic Surgery, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Herbort', 'Affiliation': 'OCM Munich, München, Germany.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120922938'] 2825,32529045,Surgery for women with endometrioma prior to in vitro fertilisation: proposal for a feasible multicentre randomised clinical trial in the UK.,"STUDY QUESTION Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF? SUMMARY ANSWER A randomised controlled trial (RCT) comparing surgery versus no surgery to endometrioma prior to IVF is only feasible in UK if an adaptive rather than traditional study design is used; this would minimise resource wastage and complete the trial in an acceptable time frame. WHAT IS KNOWN ALREADY There is wide variation in the management of endometriomas prior to IVF, with decisions about treatment being influenced by personal preferences. STUDY DESIGN SIZE AND DURATION This was a mixed-methods study consisting of an online survey of clinicians, a focus group and individual interviews with potential trial participants. PARTICIPANTS/MATERIALS SETTING METHODS Endometriosis and fertility experts across the UK were invited to participate in an online anonymised questionnaire. Potential future trial participants were recruited from a tertiary care fertility centre and invited to participate in either individual interviews or focus groups. MAIN RESULTS AND THE ROLE OF CHANCE Clinicians and potential trial participants confirmed the need for an RCT to inform the management of an endometrioma prior to IVF. There were 126 clinicians who completed the survey, and the majority (70%) were willing to recruit to a trial. Half of those who responded indicated that they see at least 10 eligible women each year. The main barriers to recruitment were waiting lists for surgery and access to public funding for IVF. One focus group ( n  = 7) and five interviews were conducted with potential trial participants ( n  = 3) and their partners ( n  = 2). The findings from these discussions highlighted that recruitment and retention in a potential RCT could be improved by coordination between IVF and surgical services such that an operation does not delay IVF or affect access to public funding. Live birth was considered the most important outcome with an improvement of at least 10% considered the minimum acceptable by both patients and clinicians. LIMITATIONS REASONS FOR CAUTION This feasibility study captured views of clinicians across the UK, but as patients were from a single Scottish centre, their views may not be representative of other areas with limited public funding for IVF. WIDER IMPLICATIONS OF THE FINDINGS There is a need for an appropriately powered RCT to establish whether or not surgical treatment of endometrioma prior to IVF improves live birth rates. There are logistical issues to be considered due to limited number of participants, funding of IVF and waiting times. These could be overcome in a RCT by using an adaptive design which would include a prospectively planned opportunity for modification of specified aspects of the study design based on interim analysis of the data, coordination of IVF treatments and endometriosis surgeries and international collaboration. Similar principles could be used for other questions in fertility where a traditional approach for randomised trials is not feasible. STUDY FUNDING/COMPETING INTERESTS Funding was received from the NHS Grampian R&D pump priming fund (RG14437-12). S.B. is Editor-in-Chief of HROPEN, and A.W.H. is Deputy Editor of HROPEN. Neither was involved in the review of this manuscript. L.S. reports grants from CSO and NIHR to do endometriosis research, outside the submitted work. K.C. reports grants from NIHR/HTA and CSO during the conduct of the study. J.H.e., A.W.H., J.D., S.B.r., K.B., G.B., J.H.u. and K.G. report no conflict of interest.",2020,"Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF? ","['Endometriosis and fertility experts across the UK were invited to participate in an online anonymised questionnaire', '126 clinicians who completed the survey, and the majority (70%) were willing to recruit to a trial', 'Potential future trial participants were recruited from a tertiary care fertility centre and invited to participate in either individual interviews or focus groups', 'women with endometrioma prior to in vitro fertilisation']",['surgery versus no surgery to endometrioma prior to IVF'],['live birth rates'],"[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}]",126.0,0.207264,"Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF? ","[{'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': 'Aberdeen Fertility Centre, NHS Grampian, Aberdeen AB25 2ZL, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Healey', 'Affiliation': 'Health Service Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Gynecology, NHS Grampian, Aberdeen AB25 2ZN, UK.'}, {'ForeName': 'Lucky', 'Initials': 'L', 'LastName': 'Saraswat', 'Affiliation': 'Gynecology, NHS Grampian, Aberdeen AB25 2ZN, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""The Queen's Medical Research InstituteEdinburgh, EH16 4TJ, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Faculty of Medical & Health Sciences, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Clinical Trials Unit, Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brian', 'Affiliation': ""Women's Voices, Royal College of Obstetricians and Gynaecologists, London, UK.""}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Burns', 'Affiliation': 'Infertility Network, London, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}]",Human reproduction open,['10.1093/hropen/hoaa012'] 2826,32529353,Correction to: A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated inguinal hernia.,"The title ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia"" should have read ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated inguinal hernia.""",2020,"The title ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia"" should have read ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated inguinal hernia.""","['total extra-peritoneal repair of uncomplicated inguinal hernia', 'total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia']",['triangular versus midline port placement'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.0462465,"The title ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia"" should have read ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated inguinal hernia.""","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Awanish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India. awanishkr79@gmail.com.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Pal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Agrawal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Pahwa', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Abhinav A', 'Initials': 'AA', 'LastName': 'Sonkar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}]",Surgical endoscopy,['10.1007/s00464-020-07693-3'] 2827,32529387,Reversed shoulder arthroplasty leads to significant histological changes of the deltoid muscle: a prospective intervention trial.,"INTRODUCTION Reverse shoulder arthroplasty (RSA) shows promising short- and mid-term results in cuff tear arthropathy. However, functional impairments are described in long-term findings. Micromorphological changes in the periarticular musculature could be in part responsible for this, but have not yet been analysed. Thus, histological changes of the deltoid muscle and their association to the functional outcome were evaluated in this study. MATERIAL AND METHODS A total of 15 patients treated with RSA were included in this prospective study. Functional outcome was assessed using the Constant Score (CS) and the DASH (disabilities of the arm, shoulder and hand) Score before RSA and after a mean follow-up of 12 months. Deltoid muscle biopsies were harvested intraoperatively and 12 months postoperatively. Mean deltoid muscle fibre area (MMFA) was calculated histologically after haematoxylin-eosin staining. RESULTS Postoperative shoulder function significantly improved within 12 months (CS: Δ 37.4 ± 22.6, p = 0.001; DASH: Δ 27.1 ± 29.1, p = 0.006). The MMFA significantly decreased (p = 0.02), comparing the results from the intraoperative biopsy (MMFA: 8435.8 µm 2 , SD ± 5995.9 µm 2 ) to the 12 months biopsy (MMFA: 5792. µm 2 , SD ± 3223.6 µm 2 ). No correlation could be found between the functional score results and MMFA. CONCLUSION Signs of deltoid muscle changes in terms of a reduced MMFA can be detected 1 year after RSA and thus already a long time before long-term functional impairments become apparent. Further studies with larger patient series and longer follow-up periods as well as extended histological assessments and simultaneous radiological examinations are required.",2020,"The MMFA significantly decreased (p = 0.02), comparing the results from the intraoperative biopsy (MMFA: 8435.8 µm 2 , SD ± 5995.9 µm 2 ) to the 12 months biopsy (MMFA: 5792. µm 2 , SD ± ",['15 patients treated with RSA'],['Reverse shoulder arthroplasty (RSA'],"['Constant Score (CS) and the DASH (disabilities of the arm, shoulder and hand) Score before RSA', 'Deltoid muscle biopsies', 'Postoperative shoulder function', 'Mean deltoid muscle fibre area (MMFA', 'MMFA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",15.0,0.0373651,"The MMFA significantly decreased (p = 0.02), comparing the results from the intraoperative biopsy (MMFA: 8435.8 µm 2 , SD ± 5995.9 µm 2 ) to the 12 months biopsy (MMFA: 5792. µm 2 , SD ± ","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Trauma Surgery, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany. matthias.koch@ukr.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Orthopaedic Department, Center for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Kerschbaum', 'Affiliation': 'Department of Trauma Surgery, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Winkler', 'Affiliation': 'Orthopaedic Department, Center for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Trauma Surgery, University Medical Centre Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Greiner', 'Affiliation': 'Sporthopaedicum Regensburg/Straubing, Hildegard-von-Bingen-Str. 1, 93053, Regensburg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03503-6'] 2828,32529467,"A randomized, double-blind, placebo-controlled study of B-cell lymphoma 2 homology 3 mimetic gossypol combined with docetaxel and cisplatin for advanced non-small cell lung cancer with high expression of apurinic/apyrimidinic endonuclease 1.","Background Overexpression of apurinic/apyrimidinic endonuclease 1 (APE1) is an important cause of poor chemotherapeutic efficacy in advanced non-small cell lung cancer (NSCLC) patients. Gossypol, a new inhibitor of APE1, in combination with docetaxel and cisplatin is believed to improve the efficacy of chemotherapy for advanced NSCLC with high APE1 expression. Methods Sixty-two patients were randomly assigned to two groups. Thirty-one patients in the experimental group received 75 mg/m 2 docetaxel and 75 mg/m 2 cisplatin on day 1 with gossypol administered at 20 mg once daily on days 1 to 14 every 21 days. The control group received placebo with the same docetaxel and cisplatin regimen. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and toxicity. Results There were no significant differences in PFS and OS between the experimental group and the control group. The median PFS (mPFS) in the experimental and control groups was 7.43 and 4.9 months, respectively (HR = 0.54; p = 0.06), and the median OS (mOS) was 18.37 and 14.7 months, respectively (HR = 0.68; p = 0.27). No significant differences in response rate and serious adverse events were found between the groups. Conclusion The experimental group had a better mPFS and mOS than did the control group, though no significant difference was observed. Because the regimen of gossypol combined with docetaxel and cisplatin was well tolerated, future studies with larger sample sizes should be performed.",2020,No significant differences in response rate and serious adverse events were found between the groups.,"['Methods Sixty-two patients', 'advanced non-small cell lung cancer (NSCLC) patients', 'advanced non-small cell lung cancer with high expression of apurinic/apyrimidinic endonuclease 1']","['placebo with the same docetaxel and cisplatin regimen', 'docetaxel and cisplatin', 'docetaxel and 75 mg/m 2 cisplatin', 'gossypol combined with docetaxel and cisplatin', 'placebo']","['median PFS (mPFS', 'overall survival (OS), response rate, and toxicity', 'median OS (mOS', 'response rate and serious adverse events', 'PFS and OS', 'progression-free survival (PFS', 'mPFS and mOS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018096', 'cui_str': 'Gossypol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",62.0,0.138209,No significant differences in response rate and serious adverse events were found between the groups.,"[{'ForeName': 'Yuxiao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Mengxia', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Dai', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Chengxiong', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China. sydqcy@hotmail.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Cancer Center, Daping Hospital & Army Medical Center of PLA, Army Medical University, 400042, Chongqing, China. dongwang64@hotmail.com.'}]",Investigational new drugs,['10.1007/s10637-020-00927-0'] 2829,32529493,The sequelae of mastectomy and quadrantectomy with respect to the reaching movement in breast cancer survivors: evidence for an integrated rehabilitation protocol during oncological care.,"BACKGROUND Breast cancer (BC) is the most common cancer among women in developed countries. Several types of surgical interventions are commonly used in BC, such as mastectomy and quadrantectomy, followed by radiation or not. Today, BC rehabilitation can help survivors obtain and maintain the highest physical, social, psychological, and vocational functioning possible, within the limits that are created by cancer and its treatments. OBJECTIVE To verify, before and after a specific rehabilitation protocol treatment, the recovery of the fluidity of the reaching movement. METHODS Patients after BC surgery were enrolled and assigned by cluster randomization into 2 groups through a block randomization list: mastectomy (Mas) and quadrantectomy (Quad). Evaluation scales (DASH and VAS) were administered, and biomechanical evaluations were performed for each group before treatment (T0 = baseline), at the end of the rehabilitative treatment (T1 = 12 sessions, 2/week), and after 3 months of follow-up (T2). RESULTS Fifty-nine (Mas group = 29; Quad group = 30) after BC surgery were enrolled. VAS scores improved along the evaluation times at T0-T1 and T0-T2 (p < 0.001), without a statistically significant difference between groups. With regard to the normalized jerk, there was no significant interaction between time group (F = 2.029; p = 0.136). There was a significant decrease between T0-T1 and T1-T2 (F = 60.189; p < 0.001). Velocity improved significantly between T0-T1 and T1-T2 (F = 10.322; p < 0.001). There was a significant interaction for the elbow angle at the end of movement between time and group at T2 (F = 5.022; p = 0.029). CONCLUSION The integrated, low-intensity, rehabilitative intervention is effective, even if it is not performed in the first period after BC surgery, without any difference between mastectomy and quadrantectomy.",2020,VAS scores improved along the evaluation times at T0-T1,"['breast cancer survivors', 'Fifty-nine (Mas group\u2009=\u200929; Quad group\u2009=\u200930) after BC surgery were enrolled', 'Patients after BC surgery']","['T0-T1', 'block randomization list: mastectomy (Mas) and quadrantectomy (Quad']","['T0-T1', 'elbow angle', 'Velocity', 'Evaluation scales (DASH and VAS', 'VAS scores']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337354', 'cui_str': 'Quadrantectomy of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0337354', 'cui_str': 'Quadrantectomy of breast'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",59.0,0.0364683,VAS scores improved along the evaluation times at T0-T1,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paolucci', 'Affiliation': ""Department of Medical, Oral and Biotechnological Sciences, G. D'Annunzio University of Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernetti', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Arianna V', 'Initials': 'AV', 'LastName': 'Bai', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Segatori', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': 'Department of Surgical Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Maggi', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Ippolitoni', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tinelli', 'Affiliation': 'University Hospital Umberto I of Rome, Rome, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Santilli', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Agostini', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy. francescoagostini.ff@gmail.com.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mangone', 'Affiliation': 'Department of Anatomical and Histological Sciences, Legal Medicine and Orthopedics, Sapienza University of Rome, Rome, Italy.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05567-x'] 2830,32529735,Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0688023,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16330'] 2831,32529753,Reduction in Circulating Advanced Glycation End Products by Mediterranean Diet is Associated with Increased Likelihood of type 2 Diabetes Remission in Patients with Coronary Heart Disease: From the Cordioprev Study.,"SCOPE We hypothesize that a decrease in advanced glycation end products (AGEs) levels could affect T2DM remission in newly-diagnosed patients through the long-term consumption of two healthy diets. METHODS AND RESULTS We included patients from CORDIOPREV study, all with previous cardiovascular event, diagnosed with T2DM at the beginning of the study with no glucose-lowering treatment. Patients were randomized to a Mediterranean or a low-fat diet for 5 years. We found no different diabetes remission rates among diets. We measured serum levels of Methylglioxal (MG) and CarboximethylLysine (CML), dietary AGE, as well as gene expression of AGER1 and RAGE. Serum MG decreased only after the consumption of the Mediterranean diet. Moreover, a COX regression analysis showed that each SD decrease in the MG, occurring after consumption of the Mediterranean diet, increases the probability of T2DM remission with HR:2.56(1.02-6.25) and p = 0.046 and each SD increase in disposition index at baseline increases the probability of remission with HR:1.94(1.32-2.87) and p = 0.001. CONCLUSIONS We have demonstrated that the reduction of serum AGEs levels and the modulation of its metabolism, occurring after the consumption of a Mediterranean diet, might be involved in the molecular mechanism underlying the T2DM remission of newly-diagnosed patients with coronary heart disease. This article is protected by copyright. All rights reserved.",2020,We found no different diabetes remission rates among diets.,"['patients from CORDIOPREV study, all with previous cardiovascular event, diagnosed with T2DM at the beginning of the study with no glucose-lowering treatment', 'newly-diagnosed patients with coronary heart disease', 'Patients with Coronary Heart Disease']",['Mediterranean or a low-fat diet'],"['serum levels of Methylglioxal (MG) and CarboximethylLysine (CML), dietary AGE, as well as gene expression of AGER1 and RAGE', 'probability of T2DM remission', 'T2DM remission', 'diabetes remission rates', 'advanced glycation end products (AGEs) levels', 'disposition index', 'Serum MG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0440039,We found no different diabetes remission rates among diets.,"[{'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutierrez-Mariscal', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Magdalena P', 'Initials': 'MP', 'LastName': 'Cardelo', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'de la Cruz', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Alcala-Diaz', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Roncero-Ramos', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Guler', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vals-Delgado', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Moreno', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Raul M', 'Initials': 'RM', 'LastName': 'Luque', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Maimonines Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, 14004, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901290'] 2832,32529788,Sample size calculation based on precision for pilot sequential multiple assignment randomized trial (SMART).,"The sequential multiple assignment randomized trial (SMART) is a design used to develop dynamic treatment regimes (DTRs). Given that DTRs are generally less well researched, pilot SMART studies are often necessary. One challenge in pilot SMART is to determine the sample size such that it is small yet meaningfully informative for future full-fledged SMART. Here, we develop a precision-based approach, where the calculated sample size confines the marginal mean outcome of a DTR within a prespecified margin of error. The sample size calculations will be presented for two-stage SMARTs, and for various common outcome types.",2020,The sequential multiple assignment randomized trial (SMART) is a design used to develop dynamic treatment regimes (DTRs).,[],[],[],[],[],[],,0.0608861,The sequential multiple assignment randomized trial (SMART) is a design used to develop dynamic treatment regimes (DTRs).,"[{'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Palash', 'Initials': 'P', 'LastName': 'Ghosh', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Bibhas', 'Initials': 'B', 'LastName': 'Chakraborty', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}]",Biometrical journal. Biometrische Zeitschrift,['10.1002/bimj.201900364'] 2833,32529868,Effect of positive end-expiratory pressure on functional residual capacity in two experimental models of acute respiratory distress syndrome.,"OBJECTIVE Measurement of positive end-expiratory pressure (PEEP)-induced recruitment lung volume using passive spirometry is based on the assumption that the functional residual capacity (FRC) is not modified by the PEEP changes. We aimed to investigate the influence of PEEP on FRC in different models of acute respiratory distress syndrome (ARDS). METHODS A randomized crossover study was performed in 12 pigs. Pulmonary (n = 6) and extra-pulmonary (n = 6) ARDS models were established using an alveolar instillation of hydrochloric acid and a right atrium injection of oleic acid, respectively. Low (5 cmH 2 O) and high (15 cmH 2 O) PEEP were randomly applied in each animal. FRC and recruitment volume were determined using the nitrogen wash-in/wash-out technique and release maneuver. RESULTS FRC was not significantly different between the two PEEP levels in either pulmonary ARDS (299 ± 92 mL and 309 ± 130 mL at 5 and 15 cmH 2 O, respectively) or extra-pulmonary ARDS (305 ± 143 mL and 328 ± 197 mL at 5 and 15 cmH 2 O, respectively). The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). CONCLUSIONS PEEP did not influence FRC in either the pulmonary or extra-pulmonary ARDS pig model.",2020,"The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). ","['acute respiratory distress syndrome', '12 pigs', 'acute respiratory distress syndrome (ARDS']","['positive end-expiratory pressure (PEEP)-induced recruitment lung volume using passive spirometry', 'positive end-expiratory pressure', 'PEEP']",['FRC and recruitment volume'],"[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]","[{'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0793061,"The recruitment volume was not significantly different between the two models (pulmonary, 341 ± 100 mL; extra-pulmonary, 351 ± 170 mL). ","[{'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiu-Mei', 'Initials': 'XM', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Ran', 'Initials': 'JR', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Cheng', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong-Liang', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Lin', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520920426'] 2834,32529884,Acupuncture at LR3 and KI3 shows a control effect on essential hypertension and targeted action on cerebral regions related to blood pressure regulation: a resting state functional magnetic resonance imaging study.,"OBJECTIVE The aim of this study was to investigate the effects of acupuncture at LR3 and KI3 on hypertension at different time points and on related cerebral regions using resting-state functional magnetic resonance imaging (rs-fMRI). METHODS We randomly divided 29 subjects into two groups: Group A (receiving acupuncture at LR3 + KI3; 15 subjects) and group B (receiving acupuncture at LR3 and a sham location not corresponding to any traditional acupuncture point; 14 subjects). Acupuncture was performed. Blood pressure (BP) changes were recorded and analyzed using SPSS 20.0 statistical software. We used a 3.0T MRI scanner and standard GE 8 channel head coil to collect whole brain fMRI data in both groups. Data analysis and processing was based on the R2009a MATLAB platform. REST 1.8 software was used to analyze the whole brain amplitude of low-frequency fluctuation (ALFF). RESULTS After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained. Acupuncture at LR3 + KI3 specifically affected brain areas involved in BP regulation, as well as those involved in auditory sense, speech, vision, movement and sensation. CONCLUSION Acupuncture at LR3 + KI3 showed positive immediate and long-term effects on BP, particularly systolic blood pressure (SBP). After ALFF analysis, we concluded that LR3 + KI3 activates brain areas related to BP regulation. In addition, after acupuncture at LR3 + KI3, a highly targeted effect was observed in brain areas associated with BP. In addition, extracerebral areas involving vision, motion control, cognition and hearing were activated, which could potentially contribute to the mitigation of hypertensive complications in patients in an advanced stage of the disease.",2020,"After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained.",[],"['acupuncture', 'acupuncture at LR3\u2009+\u2009KI3; 15 subjects) and group B (receiving acupuncture at LR3 and a sham location not corresponding to any traditional acupuncture', 'Acupuncture']","['positive immediate and long-term effects on BP, particularly systolic blood pressure (SBP', 'BP', 'Blood pressure (BP) changes', 'diastolic blood pressure (DBP']",[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450768', 'cui_str': 'LR3'}, {'cui': 'C0450663', 'cui_str': 'KI3'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0023983', 'cui_str': 'Effects, Longterm'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",29.0,0.0278318,"After acupuncture, a statistically significant reduction in BP at different time points was observed in group A. In group B, a statistically significant reduction was found only in diastolic blood pressure (DBP) and was not sustained.","[{'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Taibiao', 'Initials': 'T', 'LastName': 'Lyu', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanjie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Weinan Vocational and Technical College, Weinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhinan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzhi', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Clinical Medical College of Acupuncture and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of the Tradition Chinese Medicine, Southern Medical University, Guangzhou, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420920282'] 2835,32530124,"Collagen formula with Djulis for improvement of skin hydration, brightness, texture, crow's feet, and collagen content: A double-blind, randomized, placebo-controlled trial.","BACKGROUND The efficacy of Djulis for skin care is currently based on cellular or animal models, and the clinical aspect is not in place. AIM This clinical study is to investigate the synergistic effect of fish collagen and Djulis (Chenopodium formosanum Koidz.) for improvement of skin parameters. We used the combination of hydrolyzed collagen and Djulis to develop a new functional formula for skin improvement. PATIENTS/METHODS Fifty volunteers were randomly allocated (in a 1:1 ratio) to the placebo or collagen drink group. Volunteers were required to consume a 50 mL of a collagen drink or placebo drink daily for 8 weeks. For measurements, the indexes of skin conditions were measured at the baseline and 4 and 8 weeks. RESULTS The improvements of skin hydration, brightness, crow's feet, texture, wrinkles, pores, spots, and collagen content after 8 weeks in collagen group were 17.8%, 5.4%, 14.9%, 9.9%, 29.3%, 10.4%, 9.9%, and 22.3%, respectively. Noticeably, over 68% of subjects got improved for their skin parameters after 8-week intake of collagen drink. The improvement levels indicated competitive skin improvement effects in comparison with previous studies. CONCLUSION This clinical study demonstrates the synergistic effect of fish collagen and Djulis (the main components) for the substantial improvements in hydration, brightness, crow's feet, texture, wrinkles, pores, surface spots, and collagen content in skin. The collagen drink comprehensively improved skin parameters for most subjects after 4-week intake and manifested competitive efficiency in comparison with other similar studies. We convince that the collagen drink may delay skin aging process and improve skin aging parameters.",2020,The collagen drink comprehensively improved skin parameters for most subjects after 4-week intake and manifested competitive efficiency in comparison with other similar studies.,['Fifty volunteers'],"['fish collagen and Djulis (Chenopodium formosanum Koidz', 'placebo or collagen drink group', 'collagen drink or placebo', 'placebo']","['skin parameters', ""skin hydration, brightness, crow's feet, texture, wrinkles, pores, spots, and collagen content"", ""hydration, brightness, crow's feet, texture, wrinkles, pores, surface spots, and collagen content in skin"", ""skin hydration, brightness, texture, crow's feet, and collagen content"", 'indexes of skin conditions']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0330356', 'cui_str': 'Genus Chenopodium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0277939', 'cui_str': ""Crow's feet""}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}]",50.0,0.0480515,The collagen drink comprehensively improved skin parameters for most subjects after 4-week intake and manifested competitive efficiency in comparison with other similar studies.,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Research & Design Center, TCI CO., Ltd, Taipei, Taiwan.'}, {'ForeName': 'Ruth Audy', 'Initials': 'RA', 'LastName': 'Alexander', 'Affiliation': 'Kalbe Nutritionals Research Center, Kalbe Farma, Jakarta, Indonesia.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Liang', 'Affiliation': 'Department of Cosmetic Science, Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Dental Technology, Shu-Zen Junior College of Medicine and Management, Kaohsiung, Taiwan.'}, {'ForeName': 'Yung-Hao', 'Initials': 'YH', 'LastName': 'Lin', 'Affiliation': 'Global Business Center, TCI CO., Ltd, Taipei, Taiwan.'}, {'ForeName': 'Yung-Hsiang', 'Initials': 'YH', 'LastName': 'Lin', 'Affiliation': 'Research & Design Center, TCI CO., Ltd, Taipei, Taiwan.'}, {'ForeName': 'Leong-Perng', 'Initials': 'LP', 'LastName': 'Chan', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Chen-Meng', 'Initials': 'CM', 'LastName': 'Kuan', 'Affiliation': 'Research & Design Center, TCI CO., Ltd, Taipei, Taiwan.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13500'] 2836,32530156,[Cholecalciferol supplementation improves secondary hyperparathyroidism control in hemodialysis patients].,"Introduction: Vitamin D deficiency is common among hemodialysis (HD) patients and is an important component in the pathogenesis of secondary hyperparathyroidism (SHPT). We herein report our experience on the impact of cholecalciferol supplementation on PTH levels in a group of HD patients. Patients and methods: We selected 122 HD patients. The main selection criteria were 25- hydroxyvitamin D (25(OH)D) levels ≤30 ng/mL and SHPT defined as PTH levels >300 pg/mL or PTH levels between 150-300 pg/mL during therapy with cinacalcet or paricalcitol. 82 patients agreed to receive cholecalciferol at the fixed dose of 25,000 IU per week orally for 12 months, while the remaining 40 represented the control group. The main endopoints of the study were the reduction in PTH levels ≥30% compared to baseline values and the increase of 25(OH)D levels to values >30 ng/mL. Results: At follow-up PTH levels decreased in the supplemented group from 476 ±293 to 296 ± 207 pg/mL (p<0.001), 25(OH)D levels increased from 10.3 ± 5.7 to 33.5 ± 11.2 ng/mL (p<0.001), serum calcium increased from 8.6 ± 0.5 to 8.8 ± 0.6 mg/dL (p<0.05) while serum phosphorus did not change. In this group the mean doses of paricalcitol were significantly reduced, from 8.7 ± 4.0 to 6.1 ± 3.9 µg/week (p<0.001). Moreover, in this group there were a significant increase of hemoglobin levels, from 11.6 ± 1.3 to 12.2 ± 1.1 g/dL (p <0.01) and a significant reduction of erythropoietin doses (p<0.05). In the control group the 25(OH)D and PTH levels did not change, while cinacalcet doses increased from 21 ±14 to 43 ± 17 mg/d (p<0.01). Conclusions: Vitamin deficiency is very common in HD patients. Cholecalciferol treatment significantly increased serum 25(OH)D levels, significantly decreased PTH levels and paricalcitol doses, concurrently entailing a better control of anemia.",2020,"Cholecalciferol treatment significantly increased serum 25(OH)D levels, significantly decreased PTH levels and paricalcitol doses, concurrently entailing a better control of anemia.","['82 patients agreed to receive', '122 HD patients', 'HD patients', 'hemodialysis (HD) patients', '≤30', 'hemodialysis patients', 'a group of HD patients']","['cholecalciferol supplementation', 'cholecalciferol', 'Cholecalciferol', 'Vitamin D deficiency', 'cinacalcet or paricalcitol', 'Cholecalciferol supplementation']","['serum calcium', '25(OH)D and PTH levels', '25- hydroxyvitamin D (25(OH)D) levels', 'PTH levels', 'secondary hyperparathyroidism control', 'hemoglobin levels', 'mean doses of paricalcitol', 'PTH levels ', '25(OH)D levels', 'serum 25(OH)D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0249582', 'cui_str': 'paricalcitol'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0249582', 'cui_str': 'paricalcitol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",122.0,0.0380182,"Cholecalciferol treatment significantly increased serum 25(OH)D levels, significantly decreased PTH levels and paricalcitol doses, concurrently entailing a better control of anemia.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Massimetti', 'Affiliation': 'Centro di Riferimento di Nefrologia e Dialisi, Ospedale Belcolle, Viterbo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Research, Innovation and Brand Reputation, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Feriozzi', 'Affiliation': 'Centro di Riferimento di Nefrologia e Dialisi, Ospedale Belcolle, Viterbo, Italy.'}]",Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia,[] 2837,32530169,Application of Convolutional Neural Network in Identifying Different Levels of Isokinetic Exercise Efforts.,"Abstract Objective To develop a convolutional neural network （CNN） that can identify isokinetic knee exercises moment of force-time diagrams under different levels of efforts. Methods The 200 healthy young volunteers performed concentric isokinetic right knee flexion-extension reciprocating exercises with maximal effort as well as half the effort at angular velocities of 30°/s and 60°/s twice, respectively, with an interval of 45 min. The moment of force-time diagrams were collected. The 200 subjects were randomly divided into the training set （140 subjects） and the testing set （60 subjects）. The moment of force-time diagrams from subjects in the training set were used to train CNN model, and then the fully trained model was used to predict types of curves from the testing set. Random sampling of subjects along with subsequent development of models were performed 3 times. Results Under the circumstances of isokinetic knee exercises with maximal effort and half the effort, 2 400 moment of force-time diagrams were produced, respectively. Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%. Conclusion The CNN models developed in this study have a good effect on differentiating isokinetic moment of force-time diagrams of maximal effort exercises from those made with half the effort, which can contribute to identifying levels of efforts exerted by subjects during isokinetic knee exercises.",2020,"Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%.","['200 subjects were randomly divided into the training set （140 subjects） and the testing set （60 subjects）', '200 healthy young volunteers']",['concentric isokinetic right knee flexion-extension reciprocating exercises'],['average accuracy rate'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C4281598', 'cui_str': 'Structure of right knee region'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",200.0,0.0143402,"Classification accuracy rates of the CNN models after the 3 trainings were 91.11%, 90.49% and 92.08%, respectively, and the average accuracy rate was 91.23%.","[{'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Cui', 'Affiliation': 'Institutes of Biomedical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Shanghai Key Laboratory of Forensic Medicine, Key Laboratory of Forensic Science, Ministry of Justice, Shanghai Forensic Service Platform, Academy of Forensic Science, Shanghai 200063, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Xia', 'Affiliation': 'Shanghai Key Laboratory of Forensic Medicine, Key Laboratory of Forensic Science, Ministry of Justice, Shanghai Forensic Service Platform, Academy of Forensic Science, Shanghai 200063, China.'}, {'ForeName': 'J Q', 'Initials': 'JQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Shen', 'Affiliation': 'Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.'}]",Fa yi xue za zhi,['10.12116/j.issn.1004-5619.2020.02.012'] 2838,32530172,Application of Eye Tracker in Lie Detection.,"Abstract Objective To investigate the application value of eye tracking in lie detection. Methods The 40 subjects were randomly divided into two groups. The pupil diameter, fixation duration, points of fixation and blink frequency of the subjects in the experimental group in observing target stimulation and non-target stimulation were recorded with eye tracker after they accomplished the mock crime. The eye movement parameters of subjects in the control group were directly collected. The differences in eye movement parameters of the experimental group and the control group in observing target stimulation and non-target stimulation were analyzed by t-test. Pearson coefficient analysis of correlation between eye movement parameters that had differences was conducted. The effectiveness of eye movement parameters to distinguish between the experimental group and the control group was calculated by the receiver operator characteristic （ROC） curve. Results Participants from the experimental group had shorter average pupil diameter, longer average fixation duration and fewer fixation points （ P <0.05）, but the differences in blink frequency had no statistical significance. The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance. The average fixation duration showed a negative correlation with fixation points （ r =-0.255, P <0.05）; the average fixation duration showed a negative correlation with average pupil diameter （ r =-0.218, P <0.05）; the fixation points showed a positive correlation with average pupil diameter （ r =0.09, P <0.05）. The area under the curve of average pupil diameter, average fixation duration and fixation points was 0.603, 0.621 and 0.580, respectively. Conclusion The average pupil diameter, average fixation duration and fixation points obtained by the eye tracker under laboratory conditions can be used to detect lies.",2020,The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance.,['40 subjects'],[],"['area under the curve of average pupil diameter, average fixation duration and fixation points', 'shorter average pupil diameter, longer average fixation duration', 'average pupil diameter, average fixation duration and fixation points', 'pupil diameter, fixation duration, points of fixation and blink frequency', 'average fixation duration', 'observing target stimulation and non-target stimulation']",[],[],"[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",40.0,0.0194763,The differences in the above indicators of the control group in observing target stimulation and non-target stimulation had no statistical significance.,"[{'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Ge', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Yang', 'Affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu 610000, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Chen', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'X C', 'Initials': 'XC', 'LastName': 'Shen', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hu', 'Affiliation': 'West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Chengdu 610000, China.'}]",Fa yi xue za zhi,['10.12116/j.issn.1004-5619.2020.02.015'] 2839,32530321,Bilateral laminotomy through a unilateral approach (minimally invasive) versus open laminectomy for lumbar spinal stenosis.,"Purpose : To compare the outcomes of minimally invasive (MI) bilateral laminotomy via unilateral approach versus open laminectomy in the treatment of lumbar spinal stenosis (LSS). Materials and Methods : In this prospective study, 62 patients were treated for LSS and were assigned to one of two groups over a 6-month period. Group A comprised 37 patients that underwent MI bilateral laminotomy. Group B comprised 25 patients that underwent open laminectomy. Follow-up duration was 3 years. The primary outcomes were the visual analogue scale (VAS) pain outcome score for back and leg, the Oswestry Disability Index (ODI) and complications. Results: MI methods were superior in most primary outcomes compared to open laminectomy. VAS back pain outcome was reduced from close to 7 to 4 in both groups. VAS leg pain was reduced from 6.8 to 3.2 in MI group and from 8.7 to 3.5 in the open group ( p  > 0.05 between groups, p  < 0.05 comparing pre- to post-operative back and leg pain). ODI improved from 56.5 to 13 and 58 to 24 in MI and open groups, respectively ( p  > 0.05 between groups, p  < 0.05 comparing pre- to post-operative disability). Complication and revision rates were lower in the MI technique than open laminectomy (8 versus 56%, p  < 0.05; 3 versus 12%, p  > 0.05). Length of stay ranges were less in MI than open group (1-3 versus 7-30 days, p  > 0.05). Conclusions : Bilateral laminotomy through a unilateral approach (minimally invasive) and open laminectomy are both effective in improving pain and disability in LSS. MI procedures have an advantage in shorter hospital stays, sparing of more bony structures and lower complication rates. MI unilateral decompression is at least as good as laminectomy in the treatment of LSS.",2020,"Complication and revision rates were lower in the MI technique than open laminectomy (8 versus 56%, p  < 0.05; 3 versus 12%, p  > 0.05).","['62 patients were treated for', 'lumbar spinal stenosis (LSS', 'lumbar spinal stenosis']","['Materials and Methods ', 'MI bilateral laminotomy', 'minimally invasive (MI) bilateral laminotomy via unilateral approach versus open laminectomy', 'LSS', 'open laminectomy', 'Bilateral laminotomy through a unilateral approach (minimally invasive) versus open laminectomy']","['MI unilateral decompression', 'shorter hospital stays, sparing of more bony structures and lower complication rates', 'Complication and revision rates', 'VAS back pain outcome', 'Length of stay ranges', 'visual analogue scale (VAS) pain outcome score for back and leg, the Oswestry Disability Index (ODI) and complications', 'ODI', 'VAS leg pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}]",62.0,0.0343799,"Complication and revision rates were lower in the MI technique than open laminectomy (8 versus 56%, p  < 0.05; 3 versus 12%, p  > 0.05).","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Horan', 'Affiliation': 'Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Mohammed Ben', 'Initials': 'MB', 'LastName': 'Husien', 'Affiliation': 'Department of Neurosurgery, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Bolger', 'Affiliation': 'Department of Neurosurgery, Beaumont Hospital, Dublin, Ireland.'}]",British journal of neurosurgery,['10.1080/02688697.2020.1777253'] 2840,32531070,Effect of different general anaesthetics on ventricular repolarisation in robot-assisted laparoscopic prostatectomy.,"BACKGROUND Ventricular repolarisation is affected differently by the types of anaesthetics used. This study aimed to compare the effect of different types of anaesthetics on ventricular repolarisation during robot-assisted laparoscopic radical prostatectomy (RALP). METHODS Sixty-nine patients were randomly assigned in a 1:1:1 ratio to the Sevoflurane (sevoflurane/remifentanil), Desflurane (desflurane/remifentanil), or total intravenous anaesthesia (TIVA [propofol/remifentanil]) groups; however, only 67 patients completed the study. The primary outcome was heart rate-corrected QT (QTc) interval collected at nine time-points during RALP. Bazett's (QTcB) and Fridericia's (QTcF) formulae were used for QT interval correction. The secondary outcomes were Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio that were collected at the same time-points. RESULTS The QTcB and QTcF intervals were significantly prolonged during surgery in all groups; however, these values showed significant intergroup differences with time. After assuming the Trendelenburg position, the QTcB and QTcF intervals were significantly longer in the Desflurane group than in the other two groups, and this prolongation continued until the end of surgery. Intraoperatively, the QTcB and QTcF intervals exceeded 450 ms in six and five patients, respectively, in the Desflurane group, but in none in the TIVA group. Moreover, the incidence of intraoperative QTc interval prolongation >20 ms and >60 ms was significantly higher in the Desflurane group than in the TIVA group. There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. CONCLUSIONS To minimise QTc interval prolongation during RALP, TIVA with propofol/remifentanil is recommended for general anaesthesia.",2020,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. ","['Sixty-nine patients', '67 patients completed the study']","['general anaesthetics', 'robot-assisted laparoscopic prostatectomy', 'propofol/remifentanil', 'anaesthetics', 'Desflurane', 'robot-assisted laparoscopic radical prostatectomy (RALP', 'total intravenous anaesthesia (TIVA [propofol/remifentanil', 'Sevoflurane (sevoflurane/remifentanil', 'Desflurane (desflurane/remifentanil']","['ventricular repolarisation', 'QTcB and QTcF intervals', 'intraoperative QTc interval prolongation', 'Tp-e intervals and Tp-e/QT ratio', 'Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio', ""Bazett's (QTcB) and Fridericia's (QTcF) formulae"", 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",69.0,0.0291972,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. ","[{'ForeName': 'Jin Ha', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Deuk', 'Initials': 'YD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jongsoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Han', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Baek', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13653'] 2841,32531108,"CD34 + Cell Therapy Significantly Reduces Adverse Cardiac Events, Health Care Expenditures, and Mortality in Patients with Refractory Angina.","Patients with refractory angina who are suboptimal candidates for further revascularization have improved exercise time, decreased angina frequency, and reduced major adverse cardiac events with intramyocardial delivery of CD34 + cells. However, the effect of CD34 + cell therapy on health care expenditures before and after treatment is unknown. We determined the effect of CD34 + cell therapy on cardiac-related hospital visits and costs during the 12 months following stem cell injection compared with the 12 months prior to injection. Cardiac-related hospital admissions and procedures were retrospectively tabulated for patients enrolled at one site in one of three double-blinded, placebo-controlled CD34 + trials in the 12 months before and after intramyocardial injections of CD34 + cells vs placebo. Fifty-six patients were randomized to CD34 + cell therapy (n = 37) vs placebo (n = 19). Patients randomized to cell therapy experienced 1.57 ± 1.39 cardiac-related hospital visits 12 months before injection, compared with 0.78 ± 1.90 hospital visits 12 months after injection, which was associated with a 62% cost reduction translating to an average savings of $5500 per cell therapy patient. Patients in the placebo group also demonstrated a reduction in cardiac-related hospital events and costs, although to a lesser degree than the CD34 + group. Through 1 January 2019, 24% of CD34 + subjects died at an average of 6.5 ± 2.4 years after enrollment, whereas 47% of placebo patients died at an average of 3.7 ± 1.9 years after enrollment. In conclusion, CD34 + cell therapy for subjects with refractory angina is associated with improved mortality and a reduction in hospital visits and expenditures for cardiac procedures in the year following treatment.",2020,"Patients in the placebo group also demonstrated a reduction in cardiac-related hospital events and costs, although to a lesser degree than the CD34 + group.","['Fifty-six patients', 'Patients with Refractory Angina', 'subjects with refractory angina', 'Patients with refractory angina who are suboptimal candidates for further revascularization have improved']","['CD34 + Cell Therapy', 'placebo-controlled CD34 ', 'CD34 + cell therapy', 'CD34 + cells vs placebo', 'placebo']","['exercise time, decreased angina frequency', 'cardiac-related hospital visits and costs', 'health care expenditures', 'Adverse Cardiac Events, Health Care Expenditures, and Mortality', 'cardiac-related hospital events and costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0054953', 'cui_str': 'Lymphocyte antigen CD34'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",56.0,0.105573,"Patients in the placebo group also demonstrated a reduction in cardiac-related hospital events and costs, although to a lesser degree than the CD34 + group.","[{'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Johnson', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Losordo', 'Affiliation': 'Caladrius Biosciences, Rye Brook, New York, USA.'}, {'ForeName': 'Ross F', 'Initials': 'RF', 'LastName': 'Garberich', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Larissa I', 'Initials': 'LI', 'LastName': 'Stanberry', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Strauss', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Traverse', 'Affiliation': 'Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.'}]",Stem cells translational medicine,['10.1002/sctm.20-0046'] 2842,32531111,Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder.,"Ongoing neuroinflammation may contribute to symptoms of autism spectrum disorder (ASD) in at least a portion of affected individuals. Mesenchymal stromal cells (MSCs) have demonstrated the capacity to modulate neuroinflammation, but safety and feasibility of MSC administration in children with ASD have not been well established. In this open-label, phase I study, 12 children with ASD between 4 and 9 years of age were treated with intravenous (IV) infusions of human cord tissue mesenchymal stromal cells (hCT-MSCs), a third-party MSC product manufactured from unrelated donor umbilical cord tissue. Children received one, two, or three doses of 2 × 10 6 cells per kilogram at 2-month intervals. Clinical and laboratory evaluations were performed in person at baseline and 6 months and remotely at 12 months after the final infusion. Aside from agitation during the IV placement and infusion in some participants, hCT-MSCs were well tolerated. Five participants developed new class I anti-human leukocyte antigen (HLA) antibodies, associated with a specific lot of hCT-MSCs or with a partial HLA match between donor and recipient. These antibodies were clinically silent and not associated with any clinical manifestations to date. Six of 12 participants demonstrated improvement in at least two ASD-specific measures. Manufacturing and administration of hCT-MSCs appear to be safe and feasible in young children with ASD. Efficacy will be evaluated in a subsequent phase II randomized, placebo-controlled clinical trial.",2020,Five participants developed new class,"['children with ASD', 'young children with ASD', 'children with autism spectrum disorder', '12 children with ASD between 4 and 9\u2009years of age were treated with', 'Five participants developed new class']","['human umbilical cord tissue mesenchymal stromal cells', 'Mesenchymal stromal cells (MSCs', 'MSC', 'intravenous (IV) infusions of human cord tissue mesenchymal stromal cells (hCT-MSCs', 'hCT-MSCs', 'I anti-human leukocyte antigen ', 'placebo']","['Efficacy', 'tolerated']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0444089', 'cui_str': 'Umbilical cord tissue sample'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",12.0,0.0887289,Five participants developed new class,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Duke Center for Autism and Brain Development, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Franz', 'Affiliation': 'Duke Center for Autism and Brain Development, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': 'Duke Center for Autism and Brain Development, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'McLaughlin', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Kistler', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Waters-Pick', 'Affiliation': 'Stem Cell Transplant Laboratory, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Norin', 'Initials': 'N', 'LastName': 'Meadows', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Troy', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': 'The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina, USA.'}]",Stem cells translational medicine,['10.1002/sctm.19-0434'] 2843,32521132,Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria.,"BACKGROUND Up-regulation of hepatic delta-aminolevulinic acid synthase 1 (ALAS1), with resultant accumulation of delta-aminolevulinic acid (ALA) and porphobilinogen, is central to the pathogenesis of acute attacks and chronic symptoms in acute hepatic porphyria. Givosiran, an RNA interference therapy, inhibits ALAS1 expression. METHODS In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned symptomatic patients with acute hepatic porphyria to receive either subcutaneous givosiran (2.5 mg per kilogram of body weight) or placebo monthly for 6 months. The primary end point was the annualized rate of composite porphyria attacks among patients with acute intermittent porphyria, the most common subtype of acute hepatic porphyria. (Composite porphyria attacks resulted in hospitalization, an urgent health care visit, or intravenous administration of hemin at home.) Key secondary end points were levels of ALA and porphobilinogen and the annualized attack rate among patients with acute hepatic porphyria, along with hemin use and daily worst pain scores in patients with acute intermittent porphyria. RESULTS A total of 94 patients underwent randomization (48 in the givosiran group and 46 in the placebo group). Among the 89 patients with acute intermittent porphyria, the mean annualized attack rate was 3.2 in the givosiran group and 12.5 in the placebo group, representing a 74% lower rate in the givosiran group (P<0.001); the results were similar among the 94 patients with acute hepatic porphyria. Among the patients with acute intermittent porphyria, givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo. Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. CONCLUSIONS Among patients with acute intermittent porphyria, those who received givosiran had a significantly lower rate of porphyria attacks and better results for multiple other disease manifestations than those who received placebo. The increased efficacy was accompanied by a higher frequency of hepatic and renal adverse events. (Funded by Alnylam Pharmaceuticals; ENVISION ClinicalTrials.gov number, NCT03338816.).",2020,"Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. ","['acute hepatic porphyria', '94 patients underwent randomization (48 in the givosiran group and 46 in the placebo group', '94 patients with acute hepatic porphyria', '89 patients with acute intermittent porphyria', 'patients with acute hepatic porphyria', 'symptomatic patients with acute hepatic porphyria', 'patients with acute intermittent porphyria', 'Acute Intermittent Porphyria']","['givosiran', 'RNAi Therapeutic Givosiran', 'subcutaneous givosiran', 'placebo']","['serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions', 'mean annualized attack rate', 'urinary ALA and porphobilinogen', 'levels of ALA and porphobilinogen and the annualized attack rate', 'annualized rate of composite porphyria attacks', 'rate of porphyria attacks', 'frequency of hepatic and renal adverse events', 'hemin use and daily worst pain scores']","[{'cui': 'C0268328', 'cui_str': 'Porphobilinogen synthase deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162565', 'cui_str': 'Acute intermittent porphyria'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4688584', 'cui_str': 'givosiran'}, {'cui': 'C4042855', 'cui_str': 'RNAi-Based Therapeutics'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0032704', 'cui_str': 'Porphobilinogen'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018988', 'cui_str': 'Hemin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",94.0,0.425709,"Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. ","[{'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Sardh', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ventura', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Paula Aguilera', 'Initials': 'PA', 'LastName': 'Peiró', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rees', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stölzel', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'D Montgomery', 'Initials': 'DM', 'LastName': 'Bissell', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Herbert L', 'Initials': 'HL', 'LastName': 'Bonkovsky', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Windyga', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Silver', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Siobán B', 'Initials': 'SB', 'LastName': 'Keel', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jiaan-Der', 'Initials': 'JD', 'LastName': 'Wang', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Penelope E', 'Initials': 'PE', 'LastName': 'Stein', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Harper', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Vassiliou', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Janneke G', 'Initials': 'JG', 'LastName': 'Langendonk', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Raili', 'Initials': 'R', 'LastName': 'Kauppinen', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Minder', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Horie', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Penz', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Shangbin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ko', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Vaishnaw', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Jae B', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Simon', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gouya', 'Affiliation': ""From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King's College London, King's College Hospital, London (D.C.R., P.E.S.); Klinikum Chemnitz, Chemnitz, Germany (U.S.); the Liver Center and Porphyria Center, University of California, San Francisco, San Francisco (D.M.B., B.W.); the Section on Gastroenterology and Hepatology, Wake Forest University-North Carolina Baptist Medical Center, Winston-Salem (H.L.B.); the Department of Hemostatic Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland (J.W.); the University of Texas Medical Branch, Galveston (K.E.A.); the University of Utah, Salt Lake City (C. Parker, J.P.); the University of Michigan, Ann Arbor (S.M.S.); the Department of Medicine, Division of Hematology, University of Washington, Seattle (S.B.K.); the Center for Rare Disease and Hemophilia, Taichung Veterans General Hospital, Taichung, Taiwan (J.-D.W.); St. Ivan Rilski University Hospital, Sofia, Bulgaria (A.I.); Porphyria Center Rotterdam, Center for Lysosomal and Metabolic Disease, Department of Internal Medicine, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, the Netherlands (J.G.L.); the Department of Medicine, University Hospital of Helsinki, Helsinki, Finland (R.K.); Stadtspital Triemli, Zentrallabor, Zurich, Switzerland (E.M.); Tottori University School of Medicine, Tottori, Japan (Y.H.); Alnylam Pharmaceuticals, Cambridge, MA (C. Penz, J.C., S.L., J.J.K., M.T.S., P.G., A.V., J.B.K., A.R.S.); and the University of Paris and the Laboratory of Excellence GR-Ex, Paris, and Centre de Référence Maladies Rares Porphyries, Assistance Publique-Hôpitaux de Paris, Colombes - all in France (L.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913147'] 2844,32530412,The Effects of Intensive Versus Routine Treatment in Patients with Acute Kidney Injury.,"BACKGROUND In patients with acute kidney injury (AKI), specialized treatment-initiated in response to an early-warning system- may be beneficial compared with routine treatment. METHOD To explore effect estimators in a pilot trial (DRKS00010530), patients with AKI on regular wards of a university hospital were treated either in the usual way (control group) or more intensively (intervention group). The subjects were allotted randomly to the two treatment groups. The more intensive treatment consisted of an early warning system for a rise in the serum creatinine concentration, immediate consultation of a specialist, and the issuance of a patient kidney passport. The primary endpoint was recovery of renal function after AKI during the index hospitalization. Renal complications and process indicators were the secondary endpoints. RESULTS The proportion of patients whose renal function returned to baseline after AKI was 50% in the intervention group (N = 26) and 42% in the control group (N = 26) (odds ratio 1.4, 95% confidence interval [0.5; 4.0], p = 0.58). The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile: [6; -20]) in the intervention group and by 13 mL/min/1.73 m2 in the control group (1st-3rd quartile: [0; -25]; p = 0.09). Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis were rarer in the intervention group (15% versus 39%; p = 0.03). In the intervention group, compared with the control group, the cause of AKI was identified more frequently (27% versus 4%; p = 0.05); drugs with relevance to the kidney were discontinued more frequently (65% versus 31%; p = 0.01); and the diagnosis of AKI was more frequently documented in the patient's chart (58% versus 37%; p = 0.03). CONCLUSION Specialized consultations supported by an early warning system for AKI seem to be beneficial for patients. The findings of this pilot trial should be verified in larger-scale randomized controlled trials.",2020,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","['patients with acute kidney injury (AKI', 'Patients with Acute Kidney Injury', 'patients with AKI on regular wards of a university hospital']",['Intensive Versus Routine Treatment'],"['cause of AKI', 'renal function', 'recovery of renal function', 'calculated glomerular filtration rate', 'diagnosis of AKI', 'Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}]",,0.061064,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haase-Fielitz', 'Affiliation': 'Department of Cardiology, Brandenburg Heart Center, Immanuel Hospital, Bernau; Brandenburg Medical School Theodor Fontane; Institute of Social Medicine and Health Systems Research, Magdeburg University, Magdeburg; Department of Nephrology and Endocrinology, Ernst von Bergmann Hospital, Potsdam; Department of Urology and Pediatric Urology, Magdeburg University Hospital, Magdeburg; Department of Orthopedics and Trauma Surgery, Ameos Hospital, Schönebeck; Institute of Laboratory Medicine, Leipzig University Hospital, Leipzig; Diaverum Renal Care Center Am Neuen Garten, Potsdam; Faculty of Medicine, Otto-von-Guericke University of Magdeburg; Department of Nephrology, Essen University Hospital, Essen.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Elitok', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Isermann', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Bernt-Peter', 'Initials': 'BP', 'LastName': 'Robra', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haase', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0289'] 2845,32530426,Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial.,"BACKGROUND WHO recommends that men who have sex with men (MSM) receive gonorrhoea and chlamydia testing, but many evidence-based preventive services are unaffordable. The pay-it-forward strategy offers an individual a gift (eg, a test for sexually transmitted diseases) and then asks whether they would like to give a gift (eg, a future test) to another person. This study examined the effectiveness of a pay-it-forward programme to increase gonorrhoea and chlamydia testing among MSM in China. METHODS We did a randomised controlled superiority trial at three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China. We included MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing. Restricted randomisation was done using computer-generated permuted blocks. 30 groups were randomised into three arms (1:1:1): a pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing and then asked whether they would like to donate for testing of prospective participants, a pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing was offered at ¥150 (US$22). There was no masking to arm assignment. The primary outcome was gonorrhoea and chlamydia test uptake ascertained by administrative records. We used generalised estimating equations to estimate intervention effects with one-sided 95% CIs and a prespecified superiority margin of 20%. The trial is registered with ClinicalTrials.gov, NCT03741725. FINDINGS Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis. 101 were randomly assigned to the pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group. Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm. The estimated difference in test uptake between the pay-it-forward and standard-of-care group was 38·4% (95% CI lower bound 28·4%). Among men in the pay-it-forward arm, 54 of 57 (95%) chose to donate to support testing for others. INTERPRETATION The pay-it-forward strategy can increase gonorrhoea and chlamydia testing uptake among Chinese MSM and could be a useful tool for scaling up preventive services that carry a mandatory fee. FUNDING US National Institute of Health; Special Programme for Research and Training in Tropical Diseases, sponsored by UNICEF, UNDP, World Bank, and WHO; the National Key Research and Development Program of China; Doris Duke Charitable Foundation; and Social Entrepreneurship to Spur Health.",2020,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","['MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing', 'men who have sex with men in China', 'MSM in China', 'three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China', 'Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis', 'men who have sex with men (MSM']","['pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing', 'pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group', 'Pay-it-forward gonorrhoea and chlamydia testing', 'pay-it-forward programme', 'pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing']",['gonorrhoea and chlamydia test uptake'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",301.0,0.098425,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Tiange P', 'Initials': 'TP', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forastiere', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA; Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Li', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Mi', 'Affiliation': 'Blued, Beijing, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Weizan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: jdtucker@med.unc.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30172-9'] 2846,32530436,A Mobile Game (Safe City) Designed to Promote Children's Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial.,"BACKGROUND Children have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children's attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain. OBJECTIVE The aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children's functioning and psychosocial difficulties. METHODS This study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game-based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed. RESULTS This project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period. CONCLUSIONS If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. TRIAL REGISTRATION ClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/17756.",2020,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. ","['children studying in Grades 4-6 in Hong Kong elementary schools', 'children from injuries', 'Hong Kong school children in Grades 4-6', '504 children will play Safe City, and 504 children', 'children in Grades 4-6 who will trial the gameplay on a mobile phone']","['Safe City game-based intervention', 'traditional instructional materials (electronic and printed safety information', 'Mobile Game (Safe City', 'game-based intervention']","['safety knowledge and behaviors', 'usability and acceptability tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",504.0,0.179091,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. ","[{'ForeName': 'Rosa S', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Keith Ts', 'Initials': 'KT', 'LastName': 'Tung', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Hiu Tung', 'Initials': 'HT', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Frederick Kw', 'Initials': 'FK', 'LastName': 'Ho', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hing Sang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'King-Wa', 'Initials': 'KW', 'LastName': 'Fu', 'Affiliation': 'Journalism and Media Studies Centre, University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ting Chuen', 'Initials': 'TC', 'LastName': 'Pong', 'Affiliation': 'Department of Computer Science & Engineering, The Hong Kong University of Science and Technology, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ko Ling', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chun Bong', 'Initials': 'CB', 'LastName': 'Chow', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ip', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}]",JMIR research protocols,['10.2196/17756'] 2847,32530550,Intralesional antigen immunotherapy for the treatment of plane warts: A comparative study.,"Intralesional immunotherapy by different antigens has shown promising efficacy and safety in the treatment of warts. However, the use of these antigens for the treatment of plane warts has been investigated in 2 studies only. To evaluate the efficacy and safety of three antigens; Measles Mumps, Rubella vaccine (MMR), Candida antigen, and purified protein derivative (PPD) in the treatment of multiple plane warts. The study included 120 patients who were randomly assigned to three groups, 40 patients in each group. Each agent was injected intralesionally at a dose of 0.1 mL into the largest wart at 2-week intervals until complete clearance or for a maximum of 5 sessions. Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group and in 62.5% of the MMR group. No statistically significant difference in the therapeutic response was found between the three groups. Intralesional antigen immunotherapy seems to be a promising well-tolerated and effective therapeutic option for the treatment of multiple plane warts, with relatively higher efficacy of Candida antigen. This article is protected by copyright. All rights reserved.",2020,"Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group and in 62.5% of the MMR group.","['multiple plane warts', '120 patients who were randomly assigned to three groups, 40 patients in each group', 'plane warts']","['Intralesional immunotherapy', 'Rubella vaccine (MMR), Candida antigen, and purified protein derivative (PPD', 'Intralesional antigen immunotherapy']","['efficacy and safety', 'therapeutic response', 'Complete clearance of warts']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0276262', 'cui_str': 'Plane wart'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0035923', 'cui_str': 'Rubella virus vaccine'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]",120.0,0.0176779,"Complete clearance of warts was observed in 55% of the PPD group, in 70% of the Candida antigen group and in 62.5% of the MMR group.","[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Fawzy', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nofal', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13807'] 2848,32470440,Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.,"Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.",2020,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","['patients with follicular lymphoma treated in the CALGB 50401 (Alliance', 'patients with haematological malignancies', 'patients with haematological malignancies treated with chronically administered therapies', 'patients living with indolent disease']","['lenalidomide and lenalidomide with rituximab', 'lenalidomide']","['Toxicity', 'Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability', 'grade symptomatic toxicities', 'neutropenia and fatigue trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50401.0,0.043714,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30067-3'] 2849,31611612,Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.,"BACKGROUND Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours. METHODS We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials. RESULTS Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001). CONCLUSION SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours. CLINICAL TRIAL REGISTRATION NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.",2019,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001). ","['Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals', 'patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END', 'patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END']",['elective neck dissection'],"['overall survival (OS) and disease-free survival (DFS', 'facial/neck nerve damage; QoL', 'Occult neck disease', 'risk of death/recurrence']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026640', 'cui_str': 'Neoplasm of mouth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.620858,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001). ","[{'ForeName': 'Iain L', 'Initials': 'IL', 'LastName': 'Hutchison', 'Affiliation': 'Barts Health NHS Trust, London, UK. hutch.london@googlemail.com.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Ridout', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Sharon M Y', 'Initials': 'SMY', 'LastName': 'Cheung', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hardee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surwald', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Janavikulam', 'Initials': 'J', 'LastName': 'Thiruchelvam', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Tim K', 'Initials': 'TK', 'LastName': 'Mellor', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Brennan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldwin', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Halfpenny', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Danford', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Whitley', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Malcolm W', 'Initials': 'MW', 'LastName': 'Bailey', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woodwards', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McManners', 'Affiliation': 'NHS Forth Valley, Stirling, UK.'}, {'ForeName': 'Chi-Hwa', 'Initials': 'CH', 'LastName': 'Chan', 'Affiliation': 'Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Camilleri', 'Affiliation': 'East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Avery', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Putnam', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, Carlisle, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Smith', 'Affiliation': 'Northampton General Hospital NHS Trust, Northampton, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McVicar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grew', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hislop', 'Affiliation': 'NHS Ayrshire & Arran, Kilmarnock, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kalavrezos', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Martin', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'University College London, Cancer Research UK & UCL Cancer Trials Centre, London, UK.'}]",British journal of cancer,['10.1038/s41416-019-0587-2'] 2850,31771410,Does telerehabilitation result in inferior clinical outcomes compared with in-person care for the management of chronic musculoskeletal spinal conditions in the tertiary hospital setting? A non-randomised pilot clinical trial.,"INTRODUCTION Clinical guidelines recommend multidisciplinary non-surgical management for most musculoskeletal spinal conditions. Access to such services continues to be a barrier for many individuals residing outside metropolitan regions. The primary aim of this study was to determine whether clinical outcomes achieved via telerehabilitation are as good as those achieved via in-person care. METHODS A non-randomised pilot clinical trial was undertaken where eligible patients chose to access treatment either via telerehabilitation or in-person (control group). Outcome measures for pain-related disability, pain severity and health-related quality of life were recorded at baseline, 3-, 6- and 9-months. Secondary outcomes included patient satisfaction and technical disruptions. RESULTS Seventy-one patients were recruited (telerehabilitation, n  = 51; control group, n  = 20). Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups. Non-inferiority of telerehabilitation could not be claimed for any clinical outcome measure. There were no significant group-by-time interactions observed for either pain-related disability ( p  = 0.706), pain severity ( p  = 0.187) or health-related quality of life ( p  = 0.425) measures. The telerehabilitation group reported significantly higher levels of treatment satisfaction (median: 97 vs. 76.5; p  = 0.021); 7.9% of telerehabilitation appointments were not completed due to technical disruptions. DISCUSSION Findings indicate patients with chronic musculoskeletal spinal conditions can achieve clinically meaningful improvements in their condition when accessing care via telerehabilitation. Telerehabilitation should be considered for individuals unable to access relevant in-person services; however non-inferiority remains inconclusive and requires further exploration.",2019,Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups.,"['eligible patients chose to access treatment either via telerehabilitation or in-person (control group', 'Seventy-one patients were recruited (telerehabilitation, n \u2009=\u200951; control group, n \u2009=\u200920', 'patients with chronic musculoskeletal spinal conditions']",[],"['health-related quality of life', 'pain-related disability and health-related quality of life', 'patient satisfaction and technical disruptions', 'levels of treatment satisfaction', 'pain severity', 'pain-related disability, pain severity and health-related quality of life', 'pain-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",71.0,0.266307,Patient characteristics did not differ at baseline and clinically meaningful improvements for pain-related disability and health-related quality of life were observed in both groups.,"[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Cottrell', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Shaun P', 'Initials': 'SP', 'LastName': ""O'Leary"", 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Raymer', 'Affiliation': ""Statewide Neurosurgical and Orthopaedic Physiotherapy Screening Clinic & Multidisciplinary Service, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Anne J', 'Initials': 'AJ', 'LastName': 'Hill', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Comans', 'Affiliation': 'Centre for Health Services Research, University of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Russell', 'Affiliation': 'School of Health & Rehabilitation Sciences, University of Queensland, St Lucia, Queensland, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19887265'] 2851,31296586,Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia.,"OBJECTIVE To evaluate the long-term safety and efficacy of deutetrabenazine in patients with tardive dyskinesia (TD). METHOD Patients with TD who completed the 12 week, phase 3, placebo-controlled trials were eligible to enter this open-label, single-arm study. The open-label study consisted of a 6 week dose-escalation phase and a long-term maintenance phase (clinic visits at Weeks 4, 6 and 15, and every 13 weeks until Week 106). Patients began deutetrabenazine at 12 mg/day, titrating up to a dose that was tolerable and provided adequate dyskinesia control, based on investigator judgement, with a maximum allowed dose of 48 mg/day (36 mg/day for patients taking strong cytochrome P450 2D6 (CYP2D6) inhibitors). Safety measures included incidence of adverse events (AEs) and scales used to monitor parkinsonism, akathisia/restlessness, anxiety, depression, suicidality and somnolence/sedation. Efficacy endpoints included the change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 to 7) from baseline and the proportion of patients rated as 'Much Improved' or 'Very Much Improved' on the Clinical Global Impression of Change. RESULTS A total of 343 patients enrolled in the extension study, and there were 331 patient-years of exposure in this analysis. The exposure-adjusted incidence rates of AEs with long-term treatment were comparable to or lower than those observed in the phase 3 trials. The mean (SE) change in AIMS score was -4.9 (0.4) at Week 54 (n = 146), - 6.3 (0.7) at Week 80 (n = 66) and -5.1 (2.0) at Week 106 (n = 8). CONCLUSIONS Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD. TRIAL REGISTRATION NUMBER NCT02198794.",2019,"Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD. ","['patients with TD', '343 patients enrolled in the extension study, and there were 331 patient-years of exposure in this analysis', 'patients with tardive dyskinesia (TD', 'tardive dyskinesia', 'Patients with TD who completed the 12 week, phase 3, placebo-controlled trials were eligible to enter this open-label, single-arm study']",['deutetrabenazine'],"['incidence of adverse events (AEs) and scales used to monitor parkinsonism, akathisia/restlessness, anxiety, depression, suicidality and somnolence/sedation', ""change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 to 7) from baseline and the proportion of patients rated as 'Much Improved' or 'Very Much Improved' on the Clinical Global Impression of Change"", 'mean (SE) change in AIMS score', 'efficacious, safe, and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686347', 'cui_str': 'Tardive dyskinesia'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C4277781', 'cui_str': 'deutetrabenazine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450978', 'cui_str': 'Abnormal involuntary movement scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",343.0,0.0268899,"Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD. ","[{'ForeName': 'Hubert H', 'Initials': 'HH', 'LastName': 'Fernandez', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic Foundation, Cleveland, Ohio, USA fernanh@ccf.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stamler', 'Affiliation': 'Former employee of Teva Pharmaceuticals, La Jolla, California, USA.'}, {'ForeName': 'Mat D', 'Initials': 'MD', 'LastName': 'Davis', 'Affiliation': 'Teva Pharmaceuticals, Frazer, Pennsylvania, USA.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Factor', 'Affiliation': ""Jean and Paul Amos Parkinson's Disease and Movement Disorder Program, Emory University School of Medicine, Atlanta, Georgia, USA.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""University of South Florida Parkinson's Disease and Movement Disorders Center, Tampa, Florida, USA.""}, {'ForeName': 'Joohi', 'Initials': 'J', 'LastName': 'Jimenez-Shahed', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Ondo', 'Affiliation': 'Methodist Neurological Institute, Houston, Texas, USA.'}, {'ForeName': 'L Fredrik', 'Initials': 'LF', 'LastName': 'Jarskog', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Woods', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Bega', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'LeDoux', 'Affiliation': 'University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Shprecher', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Georgetown University, Washington, District of Columbia, USA.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2018-319918'] 2852,32525761,A prospective quasi-experimental controlled study evaluating the use of dynamic elastomeric fabric orthoses to manage common postpartum ailments during postnatal care.,"OBJECTIVE To evaluate the effectiveness of a postnatal dynamic elastomeric fabric orthoses to manage postpartum pain, improve functional capacity and enhance the quality of life arising from postnatal ailments immediately to an 8-week postpartum, compared with patients who did not wear dynamic elastomeric fabric orthoses. METHOD A total of 51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation. The subgroup of the compression shorts group wore SRC recovery shorts and received standard postnatal care. The comparison group received standard postnatal care alone. Wear compliance was monitored throughout the study. Primary outcome measure, Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36) were assessed fortnightly over 8 weeks for both groups. RESULTS The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)). However, there was insufficient evidence of a statistical difference in Numeric Pain Rating Scale score at 8 weeks when comparing the compression shorts group and comparison group (-1.17; 95%CI: (-2.35, -0.01), R 2 = .19, p  = .050). The compression shorts group met the wear compliance of the dynamic elastomeric fabric orthoses and reported an average wear of the dynamic elastomeric fabric orthoses as 9 out of 14 days for 11 h per day (SD 4.8 h) between the fortnightly timepoints. CONCLUSION The use of dynamic elastomeric fabric orthoses may be considered during postnatal care as a non-pharmacological therapeutic intervention to manage pain resulting from common postpartum ailments. While the dynamic elastomeric fabric orthoses was clinically well accepted by participants with high wearing compliance, future research with larger population samples are needed to enable statistical conclusions on the effectiveness of a dynamic elastomeric fabric orthoses in postnatal care to be made. REGISTRATION Trial registration was not required as per the Australian Government Department of Health, Therapeutic Goods Administration.",2020,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","['51 postpartum women were recruited (day 0 to 10 days post-delivery) from hospitals and community-based health clinics to participate in a prospective quasi-experimental controlled study using parallel groups without random allocation', 'patients who did not wear dynamic elastomeric fabric orthoses']","['95%CI', 'postnatal dynamic elastomeric fabric orthoses', 'dynamic elastomeric fabric orthoses', 'standard postnatal care alone']","['Numeric Pain Rating Scale, and secondary outcome measures, Roland Morris Disability Questionnaire, Pelvic Floor Impact Questionnaire-7, and Short Form (SF-36', 'Numeric Pain Rating Scale score', 'Wear compliance', 'mean (SD) Numeric Pain Rating Scale score']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",51.0,0.0465939,"The compression shorts group reported a larger reduction in mean (SD) Numeric Pain Rating Scale score (-3.09 (2.20)) from baseline to 8 weeks, compared to the comparison group (-2.00 (1.41)).","[{'ForeName': 'Jaclyn Michele', 'Initials': 'JM', 'LastName': 'Szkwara', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Milne', 'Affiliation': 'Physiotherapy Program, Bond Institute of Health and Sport, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Rathbone', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.'}]","Women's health (London, England)",['10.1177/1745506520927196'] 2853,32525863,"Energy-dense vs routine enteral nutrition in New Zealand Europeans, Māori, and Pacific Peoples who are critically ill.","AIMS To evaluate the effect of energy-dense vs routine enteral nutrition on day-90 mortality by ethnic group in critically ill adults. METHODS Pre-planned subgroup analysis of the 1,257 New Zealanders in a 4,000-participant randomised trial comparing energy-dense enteral nutrition (1.5kcal/mL) with routine enteral nutrition (1kcal/mL) in mechanically ventilated intensive care unit (ICU) patients. The primary purpose of this analysis was to evaluate responses to study treatment by ethnic group (European, Māori, and Pacific Peoples) using ethnicity data recorded in the clinical records. The secondary purpose was to compare the characteristics and outcomes of patients by ethnic group. The primary outcome was day-90 mortality. RESULTS Among 1,138 patients included in the primary outcome analysis, 165 of 569 (29.0%) assigned to energy-dense nutrition and 156 of 569 patients (27.4%) assigned to routine nutrition died by day 90 (odds ratio; 1.06; 95% CI, 0.92-1.22). There was no statistically significant interaction between treatment allocation and ethnicity with respect to day-90 mortality. Day-90 mortality rates did not vary statistically significantly by ethnic group. CONCLUSIONS Among mechanically ventilated adults in New Zealand ICUs, the effect on day-90 mortality of energy-dense vs routine enteral nutrition did not vary by ethnicity.",2020,"Day-90 mortality rates did not vary statistically significantly by ethnic group. ","['mechanically ventilated intensive care unit (ICU) patients', 'critically ill adults', '1,138 patients', 'mechanically ventilated adults in New Zealand ICUs', 'patients by ethnic group']","['Energy-dense vs routine enteral nutrition', 'energy-dense enteral nutrition (1.5kcal/mL) with routine enteral nutrition (1kcal/mL', 'energy-dense vs routine enteral nutrition']","['Day-90 mortality rates', 'day-90 mortality']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.201762,"Day-90 mortality rates did not vary statistically significantly by ethnic group. ","[{'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Reid', 'Affiliation': 'Research Fellow, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Chapman', 'Affiliation': 'Research Director, Intensive Care Unit, Royal Adelaide Hospital, Adelaide, SA, Australia; Professor, Faculty of Health and Medical Sciences, The University of Adelaide, SA, Australia; Adjunct Associate Professor, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Peake', 'Affiliation': 'Director, Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville South, SA, Australia; Professor, Faculty of Health and Medical Sciences, University of Adelaide, SA, Australia; Adjunct Associate Professor, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Intensive Care Specialist, Intensive Care Unit, Austin Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Intensive Care Specialist, Intensive Care Unit, Frankston, VIC, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Principal Research Fellow, The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Professor of Medicine & Head Endocrine Unit, Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hurford', 'Affiliation': 'ICU Trials Project Manager, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Biostatistician, Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, SA, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Little', 'Affiliation': 'Project Manager, School of Epidemiology and Preventive Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'ICU Programme Manager, Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': ""O'Connor"", 'Affiliation': 'ICU Clinical Research Manager, Royal Adelaide Hospital, Adelaide, SA, Australia; Affiliate Senior Lecturer, Acute Care Medicine, The University of Adelaide, SA, Australia.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Senior Research Fellow, Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Williams', 'Affiliation': 'Research Coordinator, Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville South, SA, Australia; Affiliate Lecturer, Acute Care Medicine, The University of Adelaide, SA, Australia; Adjunct Research Fellow, Department of Epidemiology and Preventative Medicine, Monash University, VIC, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Deputy Director, Medical Research Institute of New Zealand, Wellington; Intensive Care Specialist, Wellington Hospital, Wellington.'}]",The New Zealand medical journal,[] 2854,32525882,"Improved treatment of community-acquired pneumonia through tailored interventions: Results from a controlled, multicentre quality improvement project.","BACKGROUND Community-acquired pneumonia (CAP) is one of the leading causes of healthcare utilisation and death worldwide. Treatment according to evidence-based clinical guidelines can reduce mortality, antibiotic exposure and length of hospital stay related to CAP. LOCAL PROBLEM Several studies, including a pilot study from one of our sites, indicate that physicians show a low grade of guideline adherence when managing patients with CAP. METHODS To improve the guideline-based treatment of patients with CAP admitted to hospital, we designed a quality improvement study. Four process indicators were combined in a CAP care bundle: chest X-ray, CURB-65 severity score, lower respiratory tract samples and antibiotics within 8 hours from admission. After a 4-month baseline period, we applied multiple interventions at three hospitals during 8 months. Progression in our process indicators was measured continuously and compared with a control site without interventions. After the 8-month intervention period, we continued with a 4-month follow-up period to assess the sustainability of the improvements. RESULTS The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site. The most considerable improvements have been observed regarding documentation of CURB-65 (34% at baseline, 68% at follow-up) and the collection of lower respiratory tract samples (43% at baseline, 63% at follow-up). CONCLUSION Our study has demonstrated poor adherence to CAP guidelines at all sites at baseline. After implementing multiple tailored interventions, guideline adherence increased substantially. In conclusion, we recommend that CAP guidelines should be actively adapted in order to be followed in a daily routine.",2020,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","['patients with CAP admitted to hospital', 'patients with CAP']",[],"['care bundle utilisation rate', 'mortality, antibiotic exposure and length of hospital stay related to CAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]",,0.02297,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Fally', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Plessen', 'Affiliation': 'Unisanté, Lausanne, Switzerland.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Anhøj', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Tarp', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Lise Notander', 'Initials': 'LN', 'LastName': 'Clausen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kolte', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Diernaes', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Molzen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Regitze', 'Initials': 'R', 'LastName': 'Seerup', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Israelsen', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anne-Marie Blok', 'Initials': 'AB', 'LastName': 'Hellesøe', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Department of Internal Medicine, Section for Infectious Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}]",PloS one,['10.1371/journal.pone.0234308'] 2855,32525946,Motion sickness symptoms during jumping exercise on a short-arm centrifuge.,"Artificial gravity elicited through short-arm human centrifugation combined with physical exercise, such as jumping, is promising in maintaining health and performance during space travel. However, motion sickness symptoms could limit the tolerability of the approach. Therefore, we determined the feasibility and tolerability, particularly occurrence of motion sickness symptoms, during reactive jumping exercises on a short-arm centrifuge. In 15 healthy men, we assessed motion sickness induced by jumping exercises during short-arm centrifugation at constant +1Gz or randomized variable +0.5, +0.75, +1, +1.25 and +1.5 Gz along the body axis referenced to center of mass. Jumping in the upright position served as control intervention. Test sessions were conducted on separate days in a randomized and cross-over fashion. All participants tolerated jumping exercises against terrestrial gravity and on the short-arm centrifuge during 1 Gz or variable Gz at the center of mass without disabling motion sickness symptoms. While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps. Our study demonstrates that repetitive jumping exercises are feasible and tolerable during short-arm centrifugation. Since jumping exercises maintain muscle and bone mass, our study enables further development of exercise countermeasures in artificial gravity.",2020,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.",['15 healthy men'],"['repetitive jumping exercises', 'Artificial gravity elicited through short-arm human centrifugation combined with physical exercise']","['feasibility and tolerability, particularly occurrence of motion sickness symptoms', 'motion sickness scores', 'Motion sickness symptoms']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0370295,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Frett', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'David Andrew', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': 'Space Medicine Team (HRE-OM), European Astronaut Centre, European Space Agency, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arz', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Noppe', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Petrat', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kuemmel', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institutes of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0234361'] 2856,32525954,Gut carriage of antimicrobial resistance genes in women exposed to small-scale poultry farms in rural Uganda: A feasibility study.,"BACKGROUND Antibiotic use for livestock is presumed to be a contributor to the acquisition of antimicrobial resistance (AMR) genes in humans, yet studies do not capture AMR data before and after livestock introduction. METHODS We performed a feasibility study by recruiting a subset of women in a delayed-start randomized controlled trial of small-scale chicken farming to examine the prevalence of clinically-relevant AMR genes. Stool samples were obtained at baseline and one year post-randomization from five intervention women who received chickens at the start of the study, six control women who did not receive chickens until the end of the study, and from chickens provided to the control group at the end of the study. Stool was screened for 87 clinically significant AMR genes using a commercially available qPCR array (Qiagen). RESULTS Chickens harbored 23 AMR genes from classes found in humans as well as additional vancomycin and β-lactamase resistance genes. AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months) Women in the control group who had direct contact with the chickens sampled in the study had greater similarities in AMR gene patterns to chickens than those in the intervention group who did not have direct contact with chickens sampled (p = 0.01). However, at one year there was a trend towards increased similarity in AMR patterns between humans in both groups and the chickens sampled (p = 0.06). CONCLUSIONS Studies designed to evaluate human AMR genes in the setting of animal exposure should account for high baseline AMR rates. Concomitant collection of animal, human, and environmental samples over time is recommended to determine the directionality and source of AMR genes. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02619227.",2020,"AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months)",['women exposed to small-scale poultry farms in rural Uganda'],[],"['similarity in AMR patterns', 'AMR patterns', 'AMR gene patterns']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032850', 'cui_str': 'Fowls, Domestic'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",87.0,0.104382,"AMR patterns between intervention and control women appeared more similar at baseline than one year post randomization (PERMANOVA R2 = 0.081, p = 0.61 at baseline, R2 = 0.186, p = 0.09 at 12 months)","[{'ForeName': 'Ana A', 'Initials': 'AA', 'LastName': 'Weil', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Meti D', 'Initials': 'MD', 'LastName': 'Debela', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Muyanja', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Kakuhikire', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Baguma', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bangsberg', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Tsai', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Boston, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0229699'] 2857,32532175,Mindfulness-Enhanced Behavioral Parent Training for Clinic-Referred Families of Children With ADHD: A Randomized Controlled Trial.,"Objective: This study evaluated the efficacy of a mindfulness-enhanced behavioral parent training (BPT) group program compared to standard BPT in families of children with ADHD. Method: Parents ( N = 63) of children (aged 6-11) diagnosed with ADHD were randomly assigned to either mindful or standard BPT, and participated in 12 weekly 2-hr group sessions. Parents completed a series of questionnaires assessing mindful parenting, parenting stress, harsh discipline practices, behavioral dysregulation, and child ADHD symptoms, before and after completing the group intervention. Results: Parents in the mindful group had decreased harsh discipline practices and improved self-regulation compared to parents in the standard group. Both groups improved in parenting sense of competence and child ADHD symptoms. No significant group differences were found in mindful parenting or parenting stress. Conclusion: There are some important parental benefits to enhancing BPT with mindfulness.",2020,Results: Parents in the mindful group had decreased harsh discipline practices and improved self-regulation compared to parents in the standard group.,"['Method: Parents ( N = 63) of children (aged 6-11) diagnosed with ADHD', 'families of children with ADHD', 'Clinic-Referred Families of Children With ADHD']","['mindful or standard BPT', 'standard BPT', 'mindfulness-enhanced behavioral parent training (BPT', 'Mindfulness-Enhanced Behavioral Parent Training']","['mindful parenting or parenting stress', 'parenting sense of competence and child ADHD symptoms', 'questionnaires assessing mindful parenting, parenting stress, harsh discipline practices, behavioral dysregulation, and child ADHD symptoms', 'harsh discipline practices and improved self-regulation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0182314,Results: Parents in the mindful group had decreased harsh discipline practices and improved self-regulation compared to parents in the standard group.,"[{'ForeName': 'Janet W T', 'Initials': 'JWT', 'LastName': 'Mah', 'Affiliation': ""BC Children's Hospital, Vancouver, Canada.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""BC Children's Hospital, Vancouver, Canada.""}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Locke', 'Affiliation': ""BC Children's Hospital, Vancouver, Canada.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Carbert', 'Affiliation': ""BC Children's Hospital, Vancouver, Canada.""}]",Journal of attention disorders,['10.1177/1087054720925882'] 2858,32532221,Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial.,"BACKGROUND Falls are the leading cause of injuries among older adults. Perturbation-based balance training (PBT) is an innovative approach to fall prevention that aims to improve the reactive balance response following perturbations such as slipping and tripping. Many of these PBT studies have targeted reactive balance after slipping or tripping, despite both contributing to a large proportion of older adult falls. The goal of this randomized controlled trial was to evaluate the effects of PBT targeting slipping and tripping on laboratory-induced slips and trips. To build upon prior work, the present study included: 1) a control group; 2) separate training and assessment sessions; 3) PBT methods potentially more amenable for use outside the lab compared to methods employed elsewhere, and 4) individualized training for older adult participants. METHODS Thirty-four community-dwelling, healthy older adults (61-75 years) were assigned to PBT or a control intervention using minimization. Using a parallel design, reactive balance (primary outcome) and fall incidence were assessed before and after four sessions of BRT or a control intervention involving general balance exercises. Assessments involved exposing participants to an unexpected laboratory-induced slip or trip. Reactive balance and fall incidence were compared between three mutually-exclusive groups: 1) baseline participants who experienced a slip (or trip) before either intervention, 2) post-control participants who experienced a slip (or trip) after the control intervention, and 3) post-PBT participants who experienced a slip (or trip) after PBT. Neither the participants nor investigators were blinded to group assignment. RESULTS All 34 participants completed all four sessions of their assigned intervention, and all 34 participants were analyzed. Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%). Regarding trips, neither reactive balance nor fall incidence differed between groups. CONCLUSIONS PBT targeting slipping and tripping improved reactive balance and fall incidence after laboratory-induced slips. Improvements were not observed after laboratory-induced trips. The disparity in efficacy between slips and trip may have resulted from differences in dosage and specificity between slip and trip training. TRIAL REGISTRATION Name of Clinical Trial Registry: clinicaltrials.gov Trial Registration number: NCT04308239. Date of Registration: March 13, 2020 (retrospectively registered).",2020,"Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%).","['older adult participants', 'older adults', 'All 34 participants completed all four sessions of their assigned intervention, and all 34 participants were analyzed', 'Thirty-four community-dwelling, healthy older adults (61-75\u2009years', 'participants who experienced a slip (or trip) before either intervention, 2) post-control participants who experienced a slip (or trip) after the control intervention, and 3) post-PBT participants who experienced a slip (or trip) after PBT']","['Perturbation-based balance training targeting both slip- and trip-induced falls', 'Perturbation-based balance training (PBT', 'BRT or a control intervention involving general balance exercises', 'PBT', 'control intervention using minimization', 'separate training and assessment sessions; 3) PBT methods potentially more amenable for use outside the lab compared to methods employed elsewhere, and 4) individualized training']","['reactive balance nor fall incidence', 'reactive balance and fall incidence', 'Reactive balance and fall incidence', 'reactive balance response', 'reactive balance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080024', 'cui_str': 'Piebaldism'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0080024', 'cui_str': 'Piebaldism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",34.0,0.155587,"Regarding slips, several measures of reactive balance were improved among post-PBT participants when compared to baseline participants or post-control participants, and fall incidence among post-PBT participants (18%) was lower than among baseline participants (80%).","[{'ForeName': 'Leigh J', 'Initials': 'LJ', 'LastName': 'Allin', 'Affiliation': 'Department of Biomedical Engineering and Mechanics, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'P Gunnar', 'Initials': 'PG', 'LastName': 'Brolinson', 'Affiliation': 'Edward Via College of Osteopathic Medicine, Blacksburg, VA, USA.'}, {'ForeName': 'Briana M', 'Initials': 'BM', 'LastName': 'Beach', 'Affiliation': 'Edward Via College of Osteopathic Medicine, Blacksburg, VA, USA.'}, {'ForeName': 'Sunwook', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA.'}, {'ForeName': 'Maury A', 'Initials': 'MA', 'LastName': 'Nussbaum', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Roberto', 'Affiliation': 'Institute for Society, Culture and Environment, Center for Gerontology, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Madigan', 'Affiliation': 'Grado Department of Industrial and Systems Engineering, Virginia Tech, 250 Durham Hall (0118), 1145 Perry Street, Blacksburg, VA, USA. mlm@vt.edu.'}]",BMC geriatrics,['10.1186/s12877-020-01605-9'] 2859,32532230,Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy-the P-SELECT trial (WJOG10617G)-a randomised phase II trial by the West Japan Oncology Group.,"BACKGROUND Ramucirumab (RAM) with weekly paclitaxel (wPTX) is a standard second-line therapy for advanced or recurrent gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-PTX), an albumin-bound form of PTX, was developed to improve the therapeutic index of taxane treatment. However, the ABSOLUTE trial showed the non-inferiority of weekly nab-PTX (w-nab-PTX) to wPTX with respect to overall survival (OS) as second-line therapy for advanced or recurrent gastric cancer, and subgroup analysis of patients with peritoneal dissemination showed favourable OS and progression-free survival (PFS) in the w-nab-PTX arm compared to those in the wPTX arm. This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination. METHODS The P-SELECT trial (WJOG10617G) is a prospective, open-label, multicentre, randomised phase II study evaluating wPTX plus RAM (arm A) versus w-nab-PTX plus RAM (arm B). Key eligibility criteria include the following: 1) histologically proven adenocarcinoma, 2) unresectable or recurrent gastric cancer, 3) peritoneal dissemination, 4) intolerance or refractory to first-line therapy including fluoropyrimidines, and 5) ECOG Performance Status (PS) 0-2. Patients are randomised to either arm at a 1:1 ratio stratified by institution, PS, and severity of ascites. PTX (80 mg/m 2 ; days 1, 8, and 15) and RAM (8 mg/kg; days 1 and 15) are administered every 4 weeks in arm A, while nab-PTX (100 mg/m 2 ; days 1, 8, and 15) instead of PTX is administered in arm B. The primary endpoint is OS, and the main secondary endpoints are PFS, objective response rate, safety, neuropathy-specific quality of life, and biomarkers. To maintain a probability of ≥70% to ensure the hazard ratio for OS in arm B is lower than 0.90, 105 subjects are required. The study was initiated in October 2018 and is being conducted in 58 centres of the West Japan Oncology Group. DISCUSSION The results of this study will determine whether w-nab-PTX plus RAM has the potential to be a preferred therapeutic option for advanced and recurrent gastric cancer with peritoneal dissemination, compared to wPTX plus RAM. TRIAL REGISTRATION This study was prospectively registered in the Japan Registry of Clinical Trials (jRCTs031180022, October 1, 2018).",2020,"This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination. ","['unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy-the P-SELECT trial (WJOG10617G)-a randomised phase II trial by the West Japan Oncology Group', 'patients with peritoneal dissemination', 'Key eligibility criteria include the following: 1) histologically proven adenocarcinoma, 2) unresectable or recurrent gastric cancer, 3) peritoneal dissemination, 4) intolerance or refractory to first-line therapy including fluoropyrimidines, and 5) ECOG Performance Status (PS) 0-2', 'October 2018 and is being conducted in 58 centres of the West Japan Oncology Group', 'advanced or recurrent gastric cancer']","['PTX', 'wPTX plus RAM', 'Nanoparticle albumin-bound paclitaxel (nab-PTX', 'RAM', 'w-nab-PTX plus RAM', 'Ramucirumab (RAM) with weekly paclitaxel (wPTX', 'Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab']","['favourable OS and progression-free survival (PFS', 'overall survival (OS', 'PFS, objective response rate, safety, neuropathy-specific quality of life, and biomarkers']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C4087504', 'cui_str': 'Peritoneal dissemination'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.108982,"This study evaluated whether w-nab-PTX plus RAM is more effective than wPTX plus RAM for patients with peritoneal dissemination. ","[{'ForeName': 'Kenro', 'Initials': 'K', 'LastName': 'Hirata', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. kenro916@gmail.com.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Keio Cancer Center, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Chiyo K', 'Initials': 'CK', 'LastName': 'Imamura', 'Affiliation': 'Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita, 879-5593, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya-shi, Aichi, Japan.'}]",BMC cancer,['10.1186/s12885-020-07047-1'] 2860,32532249,Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial.,"BACKGROUND Cerebral palsy (CP), which is the leading cause of motor disability during childhood, can produce sensory and cognitive impairments at different degrees. Most recent therapeutic interventions for these patients have solely focused on upper extremities (UE), although more than 60% of these patients present lower extremities (LE) deficits. Recently, a new therapeutic concept, Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), has been proposed, involving the constant stimulation of UE and LE. Based on motor skill learning principles, HABIT-ILE is delivered in a day-camp setting, promoting voluntary movements for several hours per day during 10 consecutive week days. Interestingly, the effects of this intervention in a large scale of youngsters are yet to be observed. This is of interest due to the lack of knowledge on functional, neuroplastic and biomechanical changes in infants with bilateral CP. The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors. METHODS This international, multicentric study will include 50 pre-school children with CP from 12 to 60 months of age, comparing the effect of 50 h (2 weeks) of HABIT-ILE versus regular motor activity and/or customary rehabilitation. HABIT-ILE presents structured activities and functional tasks with continuous increase in difficulty while the child evolves. Assessments will be performed at 3 period times: baseline, two weeks later and 3 months later. The primary outcome will be the Gross Motor Function Measure 66. Secondary outcomes will include Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics. DISCUSSION The results of this study should highlight the impact of a motor, intensive, goal-directed therapy (HABIT-ILE) in pre-school children at a functional, neuroplastic and biomechanical level. In addition, this changes could demonstrated the impact of this intervention in the developmental curve of each child, improving functional ability, activity and participation in short-, mid- and long-term. NAME OF THE REGISTRY Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE). TRIAL REGISTRATION NCT04017871 REGISTRATION DATE: July 12, 2019.",2020,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors. ","['pre-school children with bilateral cerebral palsy', 'infants with bilateral CP', 'Cerebral palsy (CP', 'pre-school children at a functional, neuroplastic and biomechanical level', '50 pre-school children with CP from 12 to 60\u2009months of age, comparing the effect of 50\u2009h (2\u2009weeks) of', 'pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors', 'Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE']","['HABIT-ILE versus regular motor activity and/or customary rehabilitation', 'HABIT-ILE', 'early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE']","['lower extremities (LE) deficits', ""Both Hands Assessment, Melbourne Assessment-2, Semmes-Weinstein Monofilament Test, algometry assessments, executive function tests, ACTIVLIM-CP questionnaire, Pediatric Evaluation of Disability Inventory (computer adaptative test), Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, neuroimaging and kinematics"", 'functional ability, activity and participation in short-, mid- and long-term', 'Gross Motor Function Measure 66']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}]",,0.0546853,"The aim of this randomized controlled study is to assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors. ","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Araneda', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephane V', 'Initials': 'SV', 'LastName': 'Sizonenko', 'Affiliation': 'Division of Child Development and Growth, Department of Pediatrics, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Newman', 'Affiliation': 'Paediatric Neurology and Neurorehabilitation Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Dinomais', 'Affiliation': 'Département de Médecine Physique et de Réadaptions, CHU Angers-Capucins, Angers, France.'}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Le Gal', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Ebner-Karestinos', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Paradis', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klöcker', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Geoffroy', 'Initials': 'G', 'LastName': 'Saussez', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Demas', 'Affiliation': ""Laboratoire Angevin de Recherche en Ingénierie des Systèmes, Université d'Angers, Angers, France.""}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Bailly', 'Affiliation': 'Pediatric rehabilitation department, Fondation Ildys, Brest, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bouvier', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Pisa, Italy.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Riquelme', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Institute on Health Sciences (UINICS-Idisba), University of the Balearic Islands, Palma de Mallorca, Spain.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Brochard', 'Affiliation': 'University Hospital of Brest, Brest, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Bleyenheuft', 'Affiliation': 'Institute of Neuroscience, Université catholique de Louvain, Avenue Mounier 53 box B1.53.04, 1200, Brussels, Belgium. yannick.bleyenheuft@uclouvain.be.'}]",BMC neurology,['10.1186/s12883-020-01820-2'] 2861,32532321,"Corneal cross-linking versus standard care in children with keratoconus - a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan.","BACKGROUND The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients aged 10-16 years. This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written before the end of the patient follow-up, while the outcome of the trial is still unknown. DESIGN AND METHODS KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity. Keratoconus is a disorder of the shape of the cornea in which the normally round dome-shaped clear front window of the eye (cornea) thins progressively leading to a cone-like bulge. This impairs the ability of the eye to focus properly, causing reduced vision which requires spectacle or contact lens wear or, in a minority of patients, eventually corneal replacement by a transplant for best vision. The primary outcome measure is the between-group difference in K 2 at 18 months adjusted for K 2 at baseline examination. K 2 is the value of the steepest corneal meridian as measured on Pentacam topography. Secondary outcomes are keratoconus progression, time to keratoconus progression, visual acuity, refraction, apical corneal thickness and adverse events. Patient-reported effects will be explored by questionnaires. We describe in detail the statistical aspects of KERALINK: the outcome measures, the sample size calculation, general analysis principles, the planned descriptive statistics and statistical models, and planned subgroup and sensitivity analyses. DISCUSSION The KERALINK statistical analysis will provide comprehensive and precise information on the relative effectiveness of the two treatments. The plan will be implemented in May 2020 when follow-up for the trial is completed. TRIAL REGISTRATION EudraCT, 2016-001460-11. Registered on 19 May 2016.",2020,The primary outcome measure is the between-group difference in K 2 at 18 months adjusted for K 2 at baseline examination.,"['patients aged 10-16\u2009years', 'children with keratoconus ']","['CXL with standard care, including spectacles or contact lenses', 'corneal cross-linking (CXL', 'Corneal cross-linking versus standard care']","['keratoconus progression, time to keratoconus progression, visual acuity, refraction, apical corneal thickness and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}]","[{'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.148283,The primary outcome measure is the between-group difference in K 2 at 18 months adjusted for K 2 at baseline examination.,"[{'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. k.chowdhury@ucl.ac.uk.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Daniel F P', 'Initials': 'DFP', 'LastName': 'Larkin', 'Affiliation': 'NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, London, UK.'}]",Trials,['10.1186/s13063-020-04392-1'] 2862,32532328,Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham.,"BACKGROUND People with chronic low back pain (LBP) typically have increased pain sensitivity compared to healthy controls, however its unknown if pain sensitivity differs based on LBP trajectory at baseline or after manual therapy interventions. We aimed to compare baseline pressure pain threshold (PPT) and temporal summation (TS) between people without LBP, with episodic LBP, and with persistent LBP, and to compare changes over time in PPT and TS after a lumbar spinal manipulation or sham manipulation in those with LBP. METHODS Participants were aged 18-59, with or without LBP. Those with LBP were categorised as having either episodic or persistent LBP. PPT and TS were tested at baseline. LBP participants then received a lumbar spinal manipulation or sham, after which PPT and TS were re-tested three times over 30 min. Generalised linear mixed models were used to analyse data. RESULTS One hundred participants (49 female) were included and analysed. There were 20 non-LBP participants (mean age 31 yrs), 23 episodic LBP (mean age 35 yrs), and 57 persistent LBP (mean age 37 yrs). There were no significant differences in PPT or TS between groups at baseline. There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability. Changes in PPT and TS after the interventions did not differ between the two LBP groups. DISCUSSION We found no differences between people with no LBP, episodic LBP, or persistent LBP in baseline PPT or TS. Changes in PPT and TS following a lumbar manual therapy intervention do not appear to differ between LBP trajectories. TRIAL REGISTRATION The trial was prospectively registered with ANZCTR (ACTRN12617001094369).",2020,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","['people without LBP, with episodic LBP, and with persistent LBP', 'One hundred participants (49 female) were included and analysed', 'Participants were aged 18-59, with or without LBP', '20 non-LBP participants (mean age 31\u2009yrs), 23 episodic LBP (mean age 35\u2009yrs), and 57 persistent LBP (mean age 37\u2009yrs', 'adults with episodic and persistent low back pain trajectories', 'People with chronic low back pain (LBP']","['LBP', 'lumbar spinal manipulation']","['PPT or TS', 'pain sensitivity', 'Pressure pain threshold and temporal summation', 'baseline pressure pain threshold (PPT) and temporal summation (TS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0443150', 'cui_str': 'Baseline pressure'}]",100.0,0.151039,"There was a non-significant pattern of lower PPT (higher sensitivity) from the non-LBP group to the persistent LBP group at baseline, and high variability.","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia. sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, 90 South St, Murdoch, WA, 6150, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00326-5'] 2863,32532346,Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial.,"BACKGROUND Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there is a need to equip individuals with pain education and self-regulatory skills that are shown to improve adaptation and improve their response to medical treatments. Brief, targeted behavioral medicine interventions may efficiently address the key individual factors, improve self-regulation in the context of pain, and reduce the need for opioid therapy. This highlights the critical need for targeted, cost-effective interventions that efficiently address the key psychological factors that can amplify the need for opioids and increased risk for misuse. In this trial, the primary goal is to test the comparative efficacy of a single-session skills-based pain management class to a health education active control group among patients with chronic pain who are taking opioids. METHODS/DESIGN Our study is a randomized, double-blind clinical trial testing the superiority of our 2-h, single-session skills-based pain management class against a 2-h health education class. We will enroll 136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms. We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent. Team researchers masked to treatment assignment will assess outcomes up to 12 months post treatment. DISCUSSION This study aims to test the utility of a single-session, 2-h skills-based pain management class to improve self-regulation of pain and reduce opioid use. Findings from our project have the potential to shift current research and clinical paradigms by testing a brief and scalable intervention that could reduce the need for opioids and prevent misuse effectively, efficiently, and economically. Further, elucidation of the mechanisms of opioid use can facilitate refinement of more targeted future treatments. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03950791. Registered on 10 May 2019.",2020,"We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent.","['136 adult patients with mixed-etiology chronic pain who are taking opioid prescription medication and randomize 1:1 to one of the two treatment arms', 'patients with chronic pain who are taking opioids', 'patients with chronic pain taking prescription opioids']","['single-session skills-based pain management class', 'single-session, 2-h skills-based pain management class', 'single-session behavioral medicine class']",[],"[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004937', 'cui_str': 'Medicine, Behavioral'}]",[],136.0,0.161062,"We hypothesize superiority for the skills-based pain class for pain control, self-regulation of pain-specific distress, and reduced opioid use measured by daily morphine equivalent.","[{'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA. mziadni@stanford.edu.'}, {'ForeName': 'Abby L', 'Initials': 'AL', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Winslow', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, USA.'}]",Trials,['10.1186/s13063-020-04415-x'] 2864,32532354,Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): study protocol for a randomised controlled trial analysing clinical and cost-effectiveness of Social Stories™ in primary schools.,"BACKGROUND Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely. METHODS A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants' social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York's Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings. DISCUSSION This study addresses a much used but currently under researched intervention and results will inform school based support for primary school children with a diagnosis of ASC. TRIAL REGISTRATION The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810). The trial was retrospectively registered on 23rd April 2019.",2020,Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill.,"['Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention', 'primary schools', 'primary school children with a diagnosis of ASC', 'children with a diagnosis of Autism Spectrum Conditions (ASC', 'A multi-site pragmatic cluster', '278 participants (aged 4-11) with a clinical diagnosis of ASC, currently attending primary school in the North of England', 'Autism Spectrum Social Stories']","['RCT', 'Social Stories']",['Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months'],"[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",278.0,0.14527,Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK. barry.wright1@nhs.net.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Teige', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hodkinson', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Centre for Reviews and Dissemination, University of York, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Varley', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kingsley', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hargate', 'Affiliation': 'Child Oriented Mental Health Intervention Centre, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}]",BMC psychology,['10.1186/s40359-020-00427-z'] 2865,32532356,Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II).,"OBJECTIVES To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19. TRIAL DESIGN This is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial. PARTICIPANTS Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. INCLUSION CRITERIA hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below: 1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image. EXCLUSION CRITERIA Patients will be excluded from the study if they meet any of the following criteria. 1.Patients have received other experimental treatment for COVID-19 within the last 30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening assessment;6.Pregnant or lactating women or women using estrogen contraception;7.Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;8.Other conditions that the researchers consider not suitable for participating in this clinical trial. INTERVENTION AND COMPARATOR There will be two study groups: experimental and control. Both will receive all necessary routine treatment for COVID-19. The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x10 7 human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days. Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study. MAIN OUTCOMES 1. Primary outcome The primary outcome is Time To Clinical Improvement (TTCI). By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo). Six grades of ordered variables: GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death. ABBREVIATIONS NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation. 2. Secondary outcomes 2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure). During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days. 2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days. 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate. 2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA); 2.6 Infectious disease testing: Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3. 2.7 Immunological testing: Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry. Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses. Collect peripheral blood serum to detect various immunoglobulin changes: IgA, IgG, IgM, total IgE; Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10). 2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge). RANDOMIZATION Block randomization method will be applied by computer to allocate the participants into experimental and control groups. The random ratio is 1:1. BLINDING (MASKING) Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded. Injections of cell suspension and saline will be coded in accordance with the patient's randomisation group. The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) Twenty participants will be randomized to the experimental and control groups (10 per group). TRIAL STATUS Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020. Patients screening commenced on 16 th April and an estimated date of the recruitment of the final participants will be around end of July. . TRIAL REGISTRATION Registration: World Health Organization Trial Registry: ChiCTR2000031319; March 27,2020. ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below', 'Twenty participants', '2.3 Blood routine', 'Twenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020', '30 days;2.Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);3.Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m 2 ) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;4.Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;5.Female patients who have no sexual protection in the last 30 days prior to the screening', '1)Adults aged 18-65 years;2)Voluntarily participate in this clinical trial and sign the ""informed consent form"" or have consent from a legal representative.3)Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min', 'Protocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020', '\n\n\nParticipants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations', '2020 Other Study ID Numbers: hDPSC-CoVID-2019-02-2020', 'female subjects before menopause are examined during the screening period and follow-up period D90 ± 3. 2.9', 'patients with severe COVID-19']","['allogeneic human dental pulp stem cells', 'intravenous injection of dental pulp stem cells suspension (3.0x10 7 human DPSCs in 30ml saline solution', 'control group will receive an equal amount of saline (placebo', 'hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).4)COVID-19 featured lung lesions in chest X-ray image', 'allogeneic human dental pulp stem cells (DPSCs', 'cell suspension and saline', 'placebo']","['Time To Clinical Improvement (TTCI', 'Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus; 2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge', 'white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate', 'vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure', 'T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil', 'Safety and efficacy assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587111', 'cui_str': 'Before menopause'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517641', 'cui_str': '2.9'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0037786', 'cui_str': 'Specific gravity'}, {'cui': 'C0042052', 'cui_str': 'Urobilinogen'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0443611', 'cui_str': 'Fat globule'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0201683', 'cui_str': 'Chemical method'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442737', 'cui_str': 'Not detected'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count'}, {'cui': 'C0200641', 'cui_str': 'Basophil count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0427460', 'cui_str': 'Red cell distribution width determination'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0427566', 'cui_str': 'Macrothrombocyte'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0017649', 'cui_str': 'Globulin'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0008429', 'cui_str': 'Cholinesterase'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0003074', 'cui_str': 'Anion gap'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",20.0,0.369317,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Beijing SH Biotechnology Co., Ltd., Beijing, 100070, China.'}, {'ForeName': 'Chenliang', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zun-En', 'Initials': 'ZE', 'LastName': 'Xia', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yehenala', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Gangqiao', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Tianjin Fopcells Pharmaceutical Technology Co., Ltd, Tianjin, 300074, China.'}, {'ForeName': 'Chu-Tse', 'Initials': 'CT', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Radiation Medicine, Beijing, 100850, China. 139100026365@163.com.'}, {'ForeName': 'Songling', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Stomatology, Capital Medical University, Beijing, 100006, China. slwang@ccmu.edu.cn.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Tianyou Hospital, Wuhan University of Science and Technology, Wuhan, 430064, Hubei, China. helen-1101@hotmail.com.'}]",Trials,['10.1186/s13063-020-04380-5'] 2866,32532483,Beta Testing of a Gestational Diabetes Risk Reduction Intervention for American Indian and Alaska Native Teens.,"INTRODUCTION American Indian and Alaska Native (AIAN) girls have double the risk of obesity, pregnancy, and gestational diabetes mellitus (GDM) than the general U.S. POPULATION The purpose of this study was to beta test Stopping GDM (SGDM), a GDM risk reduction intervention for at-risk AIAN teens, before beginning a randomized controlled trial. METHOD A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program. Daughters were at risk of GDM as assessed by a BMI ≥ 85th percentile. Pre- and posttest online questionnaires evaluated the online intervention (e-book and video). RESULTS Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge. Daughters demonstrated an increased self-efficacy for healthy living and pregnancy planning. Satisfaction for the e-book, video, and online survey was moderately high to very high. DISCUSSION The SGDM intervention is feasible and acceptable in AIAN mother-daughter dyads. These findings informed the SGDM intervention and the randomized controlled trial evaluation protocol.",2020,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","['A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program', 'American Indian and Alaska Native Teens']","['SGDM intervention', 'Stopping GDM (SGDM), a GDM risk reduction intervention', 'Gestational Diabetes Risk Reduction Intervention']","['diabetes prevention, reproductive health, and GDM knowledge', 'self-efficacy']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",11.0,0.0333475,"Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge.","[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ''}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Stotz', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Yesenia', 'Initials': 'Y', 'LastName': 'Garcia-Reyes', 'Affiliation': ''}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Charron-Prochownik', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.005'] 2867,32532550,[Effect of ultrasound-guided right stellate ganglion block on perioperative atrial fibrillation in patients undergoing lung lobectomy: a randomized controlled trial].,"OBJECTIVE To observe the effects of preoperative right stellate ganglion block on perioperative atrial fibrillation in patients undergoing lung lobectomy. METHODS Two hundred patients who underwent a scheduled lobectomy were randomly divided into the S and C groups. The S group was injected with 4mL of 0.2% ropivacaine under ultrasound guidance, and the C group did not receive stellate ganglion block. The patients underwent continuous ECG monitoring, and the incidences of atrial fibrillation and other types of arrhythmias were recorded from the start of surgery to 24hours after surgery. RESULTS The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09). CONCLUSIONS The results of the study indicated that preoperative right stellate ganglion block can effectively reduce the incidence of intraoperative and postoperative atrial fibrillation.",2020,"The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09). ","['patients undergoing lung lobectomy', 'Two hundred patients who underwent a scheduled lobectomy']","['ultrasound-guided right stellate ganglion block', 'ropivacaine', 'C group did not receive stellate ganglion block', 'preoperative right stellate ganglion block']","['respective incidences of atrial fibrillation', 'incidences of atrial fibrillation and other types of arrhythmias', 'incidence of intraoperative and postoperative atrial fibrillation', 'ventricular arrhythmia', 'perioperative atrial fibrillation', 'atrial arrhythmias']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}]",200.0,0.0233805,"The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09). ","[{'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Ouyang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China.'}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Qiqi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Enjun', 'Initials': 'E', 'LastName': 'Lei', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China. Electronic address: leienjun@126.com.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.007'] 2868,32532564,"Corrigendum to 'Is regional ankle block needed in conjunction with general anaesthesia for first ray surgery? A randomised controlled trial of ultrasound guided ankle block versus ""blind"" local infiltration' [Foot and Ankle Surgery 26 (2020) 66-70].",,2020,,[],"['ultrasound guided ankle block versus ""blind"" local infiltration\' [Foot and Ankle Surgery']",[],[],"[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394745', 'cui_str': 'Local anesthetic ankle block'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}]",[],,0.104726,,"[{'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Roberts', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Randeep S', 'Initials': 'RS', 'LastName': 'Aujla', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK. Electronic address: Randeep.aujla@hotmail.co.uk.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Vinay', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Felix N', 'Initials': 'FN', 'LastName': 'Fombon', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Harvinder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Bhatia', 'Affiliation': 'Orthopaedic Surgery, Leicester General Hospital, University Hospitals of Leicester, Leicester, England, UK.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.05.006'] 2869,32532581,"Effects of Using an Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions of a Manikin: Randomized, Prospective, Crossover Study.","BACKGROUND Airway management methods during out-of-hospital cardiac arrest remain controversial. OBJECTIVES This study aimed to compare the impact of using an endotracheal tube introducer with a Macintosh laryngoscope on the first-pass success rates of final-year medical students on a manikin during continuous chest compressions with a mechanical compression device. METHODS Fifty-two final-year students of the faculty of medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions. First-pass success rates, the times of endotracheal intubations, the second endotracheal intubation attempt success rates, and the difficulty level of each method according to the participants' perceptions were measured. RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope. Second endotracheal intubation attempt success rates also did not differ by endotracheal tube introducer use. The usage of an endotracheal tube introducer required significantly longer endotracheal intubation time than using only a Macintosh laryngoscope. The perception of difficulty was significantly lower with endotracheal tube introducer use. CONCLUSION The use of an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope is not associated with higher first-pass success rates during mechanical chest compressions in adult simulations performed by final-year medical students. © 2020 Elsevier Inc.",2020,"RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.",['Fifty-two final-year students of the faculty of'],"['endotracheal tube introducer with a Macintosh laryngoscope', 'medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions', 'endotracheal tube introducer', 'Endotracheal Tube Introducer for Intubation']","['perception of difficulty', 'times of endotracheal intubations, the second endotracheal intubation attempt success rates', 'endotracheal intubation time']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}]","[{'cui': 'C0179390', 'cui_str': 'Bougie'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0210338,"RESULTS First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.","[{'ForeName': 'Asim Enes', 'Initials': 'AE', 'LastName': 'Ozbek', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Huseyin Cahit', 'Initials': 'HC', 'LastName': 'Halhalli', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Emergency Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ozerol', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Şancı', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.056'] 2870,32532601,Efficacy of homoeopathic treatment for diabetic distal symmetric polyneuropathy: A multicentric randomised double-blind placebo-controlled clinical trial.,"BACKGROUND In course of diabetes, some 20-90% of individuals eventually develop diabetic neuropathy. Looking at the disease burden research studies in Homoeopathy were conducted and have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy. OBJECTIVE To assess efficacy of individualized homoeopathic medicines in management of DDSP. METHODS A multi-centric double-blind, placebo controlled, randomised clinical trial was conducted by the Central Council for Research in Homoeopathy at six centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. Primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months. RESULTS Data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M. CONCLUSION Further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.",2020,Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group.,"['Central Council for Research in Homoeopathy at six centres with a sample size of 84', 'diabetic distal symmetric polyneuropathy', '68 enrolled cases']","['individualized homoeopathic medicines', 'homoeopathic treatment', 'placebo']","['changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score', 'change in Neuropathy Total Symptom Score-6 (NTSS-6']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",11.0,0.41428,Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group.,"[{'ForeName': 'Pritha', 'Initials': 'P', 'LastName': 'Mehra', 'Affiliation': 'DDPR CRI (H), Noida (Under CCRH). Electronic address: drpritha@gmail.com.'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Sharma', 'Affiliation': 'CCRH Hqrs., New Delhi. Electronic address: drbinduhomoeo@gmail.com.'}, {'ForeName': 'Hafeezulla', 'Initials': 'H', 'LastName': 'Baig', 'Affiliation': 'DSU, Hyderabad (under CCRH). Electronic address: drhafeezullahbaig@gmail.com.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Raveendar', 'Affiliation': 'RRI (H), Gudivada (under CCRH). Electronic address: drraveendarch@gmail.com.'}, {'ForeName': 'R V R', 'Initials': 'RVR', 'LastName': 'Prasad', 'Affiliation': 'CRU (H), Tirupati (under CCRH). Electronic address: crutpt@yahoo.co.in.'}, {'ForeName': 'M Prakash', 'Initials': 'MP', 'LastName': 'Rao', 'Affiliation': 'CRU (H), Puducherry (under CCRH). Electronic address: drmprakashrao@gmail.com.'}, {'ForeName': 'Kolli', 'Initials': 'K', 'LastName': 'Raju', 'Affiliation': 'CRU (H), Chennai (under CCRH). Electronic address: bhogirajukolli62@gmail.com.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Arya', 'Affiliation': 'CRU (H), Siliguri (under CCRH). Electronic address: jogendraarya2007@rediffmail.com.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Manchanda', 'Affiliation': 'CCRH Hqrs., New Delhi. Electronic address: rkmanchanda@gmail.com.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Katarmal', 'Affiliation': 'CCRH Hqrs., New Delhi. Electronic address: docdaisy1@gmail.com.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'CCRH Hqrs., New Delhi. Electronic address: arvinddayal@yahoo.com.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.05.007'] 2871,32532631,Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial).,"BACKGROUND Split thickness skin grafting (SSG) is an important modality for wound coverage; however, it leads to donor site morbidity. Epidermal grafting (EG) is a promising option for autologous skin grafting which offers minimal donor site morbidity, though it is not known if EG is an effective clinical alternative for SSG. This study compared the efficacy of EG as an alternative to SSG in terms of wound healing outcomes, donor site morbidity, patient satisfaction and adverse events. METHODS EPIGRAAFT is a Phase 2, randomized, open-label trial with two parallel groups: EG and SSG. Patients referred for skin grafting with a healthy granulating wound bed were included. The co-primary endpoints were the proportion of wounds healed and donor site healing time. The secondary endpoints include donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events. RESULTS Of the 61 patients screened, 44 patients were randomized. There was no difference in the proportion of wounds healed at 6 weeks (p=0.366) and 3 months(p=0.24) as well as the mean time for wound healing (p=0.12). EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001). There were no adverse events reported. CONCLUSION This study demonstrated that EG has superior donor site outcomes with faster donor site healing and lower morbidity compared to SSG, while having comparable wound healing outcomes. Patients receiving EG also experienced higher donor site satisfaction compared to SSG. ClinicalTrials.gov identifier: NCT02535481.",2020,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","['Patients referred for skin grafting with a healthy granulating wound bed were included', '61 patients screened, 44 patients were randomized']","['Split thickness skin grafting (SSG', 'split thickness skin grafting', 'Epidermal grafting (EG']","['overall satisfaction', 'mean time for wound healing', 'lower donor site morbidity', 'faster donor site healing time', 'proportion of wounds healed and donor site healing time', 'higher donor site satisfaction', 'wound healing outcomes, donor site morbidity, patient satisfaction and adverse events', 'donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events', 'proportion of wounds healed', 'Lower donor site morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",44.0,0.0865935,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","[{'ForeName': 'Muholan', 'Initials': 'M', 'LastName': 'Kanapathy', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bystrzonowski', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hachach-Haram', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Twyman', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Becker', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Institute of Medical Biology, A*Star, Immunos, Biomedical Grove, Singapore.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Faculty of Health and Medical Sciences, University of Western Australia. Electronic address: toby.richards@uwa.edu.au.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mosahebi', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.03.006'] 2872,32532654,Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.,"OBJECTIVES Postoperative delirium, associated with negative consequences including longer hospital stays and worse cognitive and physical outcomes, is frequently accompanied by sleep-wake disturbance. Our objective was to evaluate the efficacy and short-term safety of ramelteon, a melatonin receptor agonist, for the prevention of postoperative delirium in older patients undergoing orthopedic surgery. DESIGN A quadruple-masked randomized placebo-controlled trial (Clinical Trials.gov NCT02324153) conducted from March 2017 to June 2019. SETTING Tertiary academic medical center. PARTICIPANTS Patients aged 65 years or older, undergoing elective primary or revision hip or knee replacement. INTERVENTION Ramelteon (8 mg) or placebo MEASUREMENTS: Eighty participants were randomized to an oral gel cap of ramelteon or placebo for 3 consecutive nights starting the night before surgery. Trained research staff conducted delirium assessments for 3 consecutive days starting on postoperative day (POD) 0, after recovery from anesthesia, and on to POD2. A delirium diagnosis was based upon DSM-5 criteria determined by expert panel consensus. RESULTS Of 80 participants, five withdrew consent (one placebo, four ramelteon) and four were excluded (four ramelteon) after randomization. Delirium incidence during the 2 days following surgery was 7% (5 of 71) with no difference between the ramelteon versus placebo: 9% (3 of 33) and 5% (2 of 38), respectively. The adjusted odds ratio for postoperative delirium as a function of assignment to the ramelteon treatment arm was 1.28 (95% confidence interval: 0.21-7.93; z-value 0.27; p-value = 0.79). Adverse events were similar between the two groups. CONCLUSION In older patients undergoing elective primary or revision hip or knee replacement, ramelteon was not efficacious in preventing postoperative delirium.",2020,"Delirium incidence during the 2 days following surgery was 7% (5 of 71) with no difference between the ramelteon versus placebo: 9% (3 of 33) and 5% (2 of 38), respectively.","['Tertiary academic medical center', 'Patients aged 65 years or older, undergoing elective primary or revision hip or knee replacement', 'older patients undergoing orthopedic surgery', 'older patients undergoing elective primary or revision hip or knee replacement, ramelteon', 'March 2017 to June 2019', 'Eighty participants', '80 participants, five withdrew consent (one placebo, four ramelteon) and four were excluded (four ramelteon) after randomization', 'Older Patients Undergoing Orthopedic Surgery']","['oral gel cap of ramelteon or placebo', 'melatonin receptor agonist', 'Ramelteon', 'Ramelteon (8 mg) or placebo', 'placebo']","['longer hospital stays and worse cognitive and physical outcomes', 'Adverse events', 'Delirium incidence', 'postoperative delirium', 'Postoperative Delirium']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1565316', 'cui_str': 'ramelteon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1154190', 'cui_str': 'Oral gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1565316', 'cui_str': 'ramelteon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541970', 'cui_str': 'Melatonin receptor agonists'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",80.0,0.653599,"Delirium incidence during the 2 days following surgery was 7% (5 of 71) with no difference between the ramelteon versus placebo: 9% (3 of 33) and 5% (2 of 38), respectively.","[{'ForeName': 'Esther S', 'Initials': 'ES', 'LastName': 'Oh', 'Affiliation': 'Departments of Medicine (ESO, AP, NSF, NA), Johns Hopkins University School of Medicine, Baltimore, MD; Departments of Psychiatry and Behavioral Sciences (ESO, JML, PBR, KJN), Johns Hopkins University School of Medicine, Baltimore, MD; Department of Pathology (ESO), Johns Hopkins University School of Medicine, Baltimore, MD; Johns Hopkins University School of Nursing (ESO, KJN), Baltimore, MD. Electronic address: eoh9@jhmi.edu.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences (ESO, JML, PBR, KJN), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences (ESO, JML, PBR, KJN), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Pletnikova', 'Affiliation': 'Departments of Medicine (ESO, AP, NSF, NA), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Harpal S', 'Initials': 'HS', 'LastName': 'Khanuja', 'Affiliation': 'Departments of Orthopedic Surgery (HSK, RSS, JKO), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sterling', 'Affiliation': 'Departments of Orthopedic Surgery (HSK, RSS, JKO), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Julius K', 'Initials': 'JK', 'LastName': 'Oni', 'Affiliation': 'Departments of Orthopedic Surgery (HSK, RSS, JKO), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Frederick E', 'Initials': 'FE', 'LastName': 'Sieber', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine (FES), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Fedarko', 'Affiliation': 'Departments of Medicine (ESO, AP, NSF, NA), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Akhlaghi', 'Affiliation': 'Departments of Medicine (ESO, AP, NSF, NA), Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Neufeld', 'Affiliation': 'Departments of Psychiatry and Behavioral Sciences (ESO, JML, PBR, KJN), Johns Hopkins University School of Medicine, Baltimore, MD; Johns Hopkins University School of Nursing (ESO, KJN), Baltimore, MD.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.006'] 2873,32532687,Mild Inflammation in Healthy Males Induces Fatigue Mediated by Changes in Effective Connectivity Within the Insula.,"BACKGROUND Systemic inflammation is associated with sickness behaviors such as low mood and fatigue. Activity patterns within the insula are suggested to coordinate these behaviors but have not been modeled. We hypothesized that mild systemic inflammation would result in changes in effective connectivity between the viscerosensory and the visceromotor regions of the insula. METHODS We used a double-blind, crossover design to randomize 20 male subjects to receive either a Salmonella typhi vaccine or a placebo saline injection at two separate sessions. All participants underwent a resting-state functional magnetic resonance scan 3 hours after injection. We determined behavioral and inflammatory changes, using the Profile of Mood States questionnaire and interleukin-6 levels. We extracted effective connectivity matrices between bilateral mid/posterior (viscerosensory) and anterior (visceromotor) insular cortices using spectral dynamic causal modeling. We applied parametric empirical Bayes and mediation analysis to determine a vaccination effect on effective connectivity and whether this mediated behavioral changes. RESULTS The vaccine condition was associated with greater interleukin-6 levels and greater fatigue 3 hours after the injection. Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions. This connectivity was augmented by vaccination over a 99% posterior confidence threshold. The right mid/posterior insula-to-left anterior insula connectivity was significantly associated with fatigue and mediated the association between inflammation and increased fatigue scores. CONCLUSIONS These results demonstrate that increased effective connectivity between specific nodes of the insula can model and mediate the association between inflammation and fatigue in males.",2020,Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions.,"['20 male subjects', 'Healthy Males']",['Salmonella typhi vaccine or a placebo saline injection'],"['interleukin-6 levels', 'Mood States questionnaire and interleukin-6 levels', 'fatigue scores', 'Mild Inflammation']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522567', 'cui_str': 'Mild inflammation'}]",20.0,0.215377,Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions.,"[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Stefanov', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom. Electronic address: kristian.stefanov@glasgow.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McLean', 'Affiliation': 'Institute for Neurological Sciences, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McColl', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Basu', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cavanagh', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom; Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Krishnadas', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, United Kingdom. Electronic address: rajeev.krishnadas@glasgow.ac.uk.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.04.005'] 2874,32532698,Satisfaction or Distraction: Exposure to Nonpreferred Music May Alter the Learning Curve for Surgical Trainees.,"OBJECTIVE There is growing evidence supporting the benefits of preferred music on task performance, however there is a paucity of data regarding the potential impact on surgical and procedural learners. This study aims to assess the effects of nonpreferred music on surgical and procedural learners. DESIGN This was a single-blinded, randomized crossover trial in which each participant completed a survey regarding their demographic information and music preferences. Each participant then completed 3 training tasks, and 2 repetitions of the evaluative task while listen to music. Tasks were completed using a Da Vinci Skills Simulator Si. SETTING All tasks were completed in a live operating room at the University of Kansas Hospital, a tertiary care center. PARTICIPANTS Medical students at the University of Kansas Medical Center were recruited by email to participate. In total, 31 medical students completed the experience. RESULTS Thirty-one participants participated in this study. Group 2 (preferred music first, nonpreferred music second) showed no significant change in their test scores (72.73 vs 74.33, p = 0.34). However, Group 1 (nonpreferred music first, then preferred music) showed significant improvement between trial runs (70.31 vs 81.88, p < 0.001). There was no significant difference between the initial runs for each group. When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025). CONCLUSIONS Participants showed expected improvement with task repetition. This improvement may have been offset by exposure to nonpreferred music during repeat runs. Our findings suggest that the impact of music was nearly as large as the impact of prior exposure to the task. This may have implications for environmental conditions during resident procedural training, especially early in residency training when new tasks are being introduced and the skill level of the learner is still low.",2020,"When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025). ","['All tasks were completed in a live operating room at the University of Kansas Hospital, a tertiary care center', 'Medical students at the University of Kansas Medical Center were recruited by email to participate', '31 medical students completed the experience', 'Thirty-one participants participated in this study']","['nonpreferred music', 'Nonpreferred Music']","['task repetition', 'test scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.134697,"When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025). ","[{'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Gil', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas. Electronic address: kgil@kumc.edu.'}, {'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Mouw', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mazin', 'Initials': 'M', 'LastName': 'Al-Kasspooles', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Tejal', 'Initials': 'T', 'LastName': 'Brahmbhatt', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'DiPasco', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.04.019'] 2875,32532700,The Hunger Games: Laparoscopic Performance in Novice Surgeons is Not Altered by Food Deprivation but Influenced by the Degree of Appetite - A Randomized Controlled Trial.,"OBJECTIVES Food deprivation is a common condition for visceral surgeons and especially laparoscopic approaches require high levels of concentration. The current literature does not provide adequate answers whether intraoperative breaks, especially food intake, might influence the quality of the surgical skills. Thus, the primary aim of this trial was to analyze the influence of food deprivation on the laparoscopic performance. DESIGN SETTING AND PARTICIPANTS 37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center, prospective-randomized trial and were trained during laparoscopic training sessions until they reached a predefined level of proficiency. Subsequently, participants were randomized into 3 different groups: food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam. The exam comprised PEG-transfer, precise cutting, gallbladder resection and surgical knot. MAIN FINDINGS Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot was 63s, 139s, 192s and 272s respectively. Participants starving for 8 hours performed 3 of 4 tasks more slowly whilst participants starving for 4 hours performed 3 of 4 tasks faster than the average. Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s). Additionally, hungry students had been more inaccurate during the surgical knot (p <0.05) whilst students with intermediate appetite level tend to be most accurate (p - value 0.012). CONCLUSIONS The subjective level of appetite rather than the absolute number of fasting hours influences the laparoscopic performance most. Thus, any extreme level of appetite may be avoided and surgeons may achieve the best performance when they have an intermediate level of appetite. In consequence, heavy meals may be omitted immediately prior to demanding laparoscopic procedures and surgeons may have access to mini-breaks and refreshers during major procedures.",2020,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,['37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center'],"['laparoscopic training sessions', 'food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam']","['Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016464', 'cui_str': 'Food Deprivation'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0560032', 'cui_str': 'knot'}]",37.0,0.0776599,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bechtolsheim', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Oppermann', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reissfelder', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Soeren T', 'Initials': 'ST', 'LastName': 'Mees', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of General, Visceral, and Thoracic Surgery, Municipal Hospital Dresden-Friedrichstadt, Dresden, Germany.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: cui.yang@umm.de.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.029'] 2876,32532705,Naltrexone in Compulsive Sexual Behavior Disorder: A Feasibility Study of Twenty Men.,"BACKGROUND Compulsive sexual behavior disorder (CSBD) is a common disorder affecting different areas of life, although studies focusing on pharmacological treatment are sparse. AIM To investigate whether the opioid receptor antagonist naltrexone is feasible and tolerable and can provide symptom reduction in CSBD. METHODS Twenty men aged 27-60 years (mean = 38.8 years, standard deviation = 10.3) with CSBD seeking treatment in an outpatient nonforensic clinic received four weeks of naltrexone 25-50 mg. Measurements were made before, during, and four weeks after treatment. OUTCOMES The self-assessment Hypersexual Disorder: Current Assessment Scale (HD: CAS) score was the primary outcome measure, and secondary outcomes were the Hypersexual Behavior Inventory (HBI) score, reported adverse effects, adherence to treatment, and dropouts. RESULTS There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone. Even though some of the effects remained after treatment, the increased scores on HD: CAS indicated worsening of CSBD symptoms. The most reported side effects were fatigue (55%), nausea (30%), vertigo (30%), and abdominal pain (30%). However, there were no serious adverse effects leading to discontinuation of naltrexone. CLINICAL IMPLICATIONS Despite side effects being common, naltrexone seems to be feasible in the treatment of CSBD. STRENGTHS & LIMITATIONS Being the first nonforensic prospective trial on naltrexone in CSBD, this study provides novel insights on a pharmacological intervention. However, owing to the small sample size and the lack of a control group, conclusions of effectiveness should be interpreted with caution. CONCLUSION Naltrexone is feasible and tolerable and may reduce symptoms of CSBD; nevertheless, future studies should ensure a randomized controlled procedure to evaluate possible effectiveness. Savard J, Öberg KG, Chatzittofis A, et al. Naltrexone in Compulsive Sexual Behavior Disorder: A Feasibility Study of Twenty Men. J Sex Med 2020;XX:XXX-XXX.",2020,There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone.,"['Twenty men aged 27-60 years (mean\xa0= 38.8 years, standard deviation\xa0= 10.3) with CSBD seeking treatment in an outpatient nonforensic clinic received four weeks of', 'Twenty Men', 'Compulsive Sexual Behavior Disorder']","['opioid receptor antagonist naltrexone', 'naltrexone', 'Naltrexone', 'naltrexone 25-50 mg']","['self-assessment Hypersexual Disorder', 'CSBD symptoms', 'Current Assessment Scale (HD: CAS) score', 'Hypersexual Behavior Inventory (HBI) score, reported adverse effects, adherence to treatment, and dropouts', 'vertigo', 'nausea', 'abdominal pain', 'HD: CAS and HBI scores']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0312420', 'cui_str': 'Hypersexuality state'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0312420', 'cui_str': 'Hypersexuality state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",20.0,0.0529634,There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden. Electronic address: josephine.savard@umu.se.'}, {'ForeName': 'Katarina Görts', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Chatzittofis', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Medical School, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.318'] 2877,32532761,Analysis of choriocapillaris perfusion and choroidal layer changes in patients with chronic central serous chorioretinopathy randomised to micropulse laser or photodynamic therapy.,"PURPOSE The purpose of this study was to investigate the signal changes in choriocapillaris flow deficits and choroidal thickness changes using swept-source optical coherence tomography angiography (OCTA) following different treatments. DESIGN A double-blind, randomised controlled trial. METHODS Patients with unilateral chronic central serous chorioretinopathy (CSC) were randomised to receive subthreshold micropulse laser therapy (MLT) or half-dose photodynamic therapy (PDT). Choroidal thickness and choriocapillaris flow deficit signals were investigated. RESULTS Eighteen patients were randomised into the MLT group and 15 patients into the PDT group. Areas with flow deficit signals were identified in all baseline OCTA images of the choriocapillaris, with mean areas of 0.420 and 0.465 mm 2 in the MLT and PDT groups, respectively. These flow deficit signal areas were significantly reduced at 6 months (p=0.011) in the MLT group and at 3 months (p=0.008) in the PDT group. Patients from the PDT group were shown to have smaller flow deficit areas than patients from the MLT group at all time points after treatment (p=0.001, analyses of variance). The mean choroidal volume of the fovea showed a significant reduction at 1 month (p=0.003), 3 months (p=0.199) and 6 months (p=0.006) in the PDT group. CONCLUSION The flow deficit areas identified in the choriocapillaris layer may suggest possible relative choroidal ischaemia. With measurement of choroidal volume reduction and faster rates of flow deficit area change, PDT has a stronger effect than MLT in promoting choriocapillaris recovery.",2020,These flow deficit signal areas were significantly reduced at 6 months (p=0.011) in the MLT group and at 3 months (p=0.008) in the PDT group.,"['Patients with unilateral chronic central serous chorioretinopathy (CSC', 'Eighteen patients', 'patients with chronic central serous chorioretinopathy']","['micropulse laser or photodynamic therapy', 'MLT', 'swept-source optical coherence tomography angiography (OCTA', 'subthreshold micropulse laser therapy (MLT) or half-dose photodynamic therapy (PDT']","['smaller flow deficit areas', 'mean choroidal volume of the fovea', 'flow deficit signal areas', 'Choroidal thickness and choriocapillaris flow deficit signals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0730314', 'cui_str': 'Chronic central serous chorioretinopathy'}, {'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229143', 'cui_str': 'Structure of lamina choroidocapillaris'}]",18.0,0.0701863,These flow deficit signal areas were significantly reduced at 6 months (p=0.011) in the MLT group and at 3 months (p=0.008) in the PDT group.,"[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Frank Hiu Ping', 'Initials': 'FHP', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology, Caritas Medical Centre, Hong Kong, China.'}, {'ForeName': 'Danny Siu Chun', 'Initials': 'DSC', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Lawrence Pui Leung', 'Initials': 'LPL', 'LastName': 'Iu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Andrew Chun Yue', 'Initials': 'ACY', 'LastName': 'Mak', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Yip', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Alvin Lerrmann', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Marten', 'Initials': 'M', 'LastName': 'Brelen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China marten.brelen@cuhk.edu.hk.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316076'] 2878,32527192,Randomized Comparison of Intensified and Standard P2Y 12 -Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial.,"BACKGROUND Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. METHODS This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. RESULTS Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P =0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32), P =0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73), P =0.70, respectively. CONCLUSIONS In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.",2020,"At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P =0.64).","['biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI', '781 patients included in the final analysis']","['elective PCI prasugrel 60 mg (ILS', 'Intensified and Standard P2Y 12 -Receptor-Inhibition', 'aspirin', 'clopidogrel']","['efficacy or safety', 'bleeding rates']","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",781.0,0.200622,"At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P =0.64).","[{'ForeName': 'Julinda', 'Initials': 'J', 'LastName': 'Mehilli', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Baquet', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Hochholzer', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäres Herzzentrum Freiburg, Bad Krozingen, Germany (W.H., F.-J.N.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tesche', 'Affiliation': 'Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany (C.T., E.H.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Budapest, Hungary (D.A.).'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany (Y.X., U.M.).'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Thienel', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gschwendtner', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Zadrozny', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jochheim', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany (Y.X., U.M.).'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hoffmann', 'Affiliation': 'Klinik für Kardiologie und internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany (C.T., E.H.).'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (K.M., S.S., A.K.).'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäres Herzzentrum Freiburg, Bad Krozingen, Germany (W.H., F.-J.N.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany (J.M., M.B., M.T., S.G., M.Z., D.J., D.S., S.M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008649'] 2879,32527195,Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study.,"OBJECTIVES Expiratory muscle strength training (EMST) is a threshold based device-driven treatment for improving expiratory pressure. EMST proved to be effective in different patient groups to improve cough function. To date, EMST has not been tested in the total laryngectomy population (TL). METHODS This prospective, randomized case-series study examined feasibility, safety, and compliance of EMST in a group of TL participants and its effects on pulmonary function, physical exertion, fatigue, and vocal functioning. Ten TL participants were included in the study to perform a 4 till 8 weeks of EMST. Objective and subjective outcome measures included manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and patient reported outcome measures. Group means were reported and estimates of the effect are shown with a 95% confidence interval, using single sample t-tests. RESULTS Nine participants completed the full study protocol. Compliance to the training program was high. All were able to perform the training, although it requires adjustments of the device and skills of the participants. Maximum expiratory pressure (MEP) and vocal functioning in loudness improved over time. After EMST no changes were seen in other objective and subjective outcomes. CONCLUSIONS EMST appears to be feasible and safe after total laryngectomy. MEP improved over time but no improvement in the clinically relevant outcome measures were seen in this sample of relatively fit participants. Further investigation of the training in a larger group of participants who report specifically pulmonary complaints is recommended to investigate if the increase in MEP results in clinical benefits. LEVEL OF EVIDENCE 4.",2020,"After EMST no changes were seen in other objective and subjective outcomes. ","['patients', 'Ten TL participants were included in the study to perform a 4 till 8\u2009weeks of EMST']","['Expiratory Muscle Strength Training', 'MEP', 'Expiratory muscle strength training (EMST', 'EMST']","['Maximum expiratory pressure (MEP) and vocal functioning in loudness improved over time', 'pulmonary function, physical exertion, fatigue, and vocal functioning', 'cough function', 'manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and patient reported outcome measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}]","[{'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C1532868', 'cui_str': 'Vocal function'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",10.0,0.0790339,"After EMST no changes were seen in other objective and subjective outcomes. ","[{'ForeName': 'Klaske E', 'Initials': 'KE', 'LastName': 'van Sluis', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Kornman', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Wim G', 'Initials': 'WG', 'LastName': 'Groen', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Prof Michiel W M', 'Initials': 'PMWM', 'LastName': 'van den Brekel', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'van der Molen', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Hoffman-Ruddy', 'Affiliation': 'School of Communication Sciences and Disorders, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Martijn M', 'Initials': 'MM', 'LastName': 'Stuiver', 'Affiliation': 'Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, The Netherlands.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420931889'] 2880,32527221,The effect of 10-min dispatch-assisted cardiopulmonary resuscitation training: a randomized simulation pilot study.,"BACKGROUND Immediate bystander cardiopulmonary resuscitation (CPR) is essential for survival from sudden cardiac arrest (CA). Current CPR guidelines recommend that dispatchers assist lay rescuers performing CPR (dispatch-assisted CPR (DACPR)), which can double the frequency of bystander CPR. Laypersons, however, are not familiar with receiving CPR instructions from dispatchers. DACPR training can be beneficial for lay rescuers, but this has not yet been validated. The aim of this study was to determine the effectiveness of simple DACPR training for lay rescuers. METHODS We conducted a DACPR simulation pilot study. Participants who were non-health care professionals with no CPR training within 1 year prior to this study were recruited from Nara Medical University Hospital. The participants were randomly assigned to one of the two 90-min adult basic life support (BLS) training course groups: DACPR group (standard adult BLS training plus an additional 10-min DACPR training) or Standard group (standard adult BLS training only). In the DACPR group, participants practiced DACPR through role-playing of a dispatcher and an emergency caller. Six months after the training, all subjects were asked to perform a 2-min CPR simulation under instructions given by off-duty dispatchers. RESULTS Out of the 66 participants, 59 completed the simulation (30 from the DACPR group and 29 from the Standard group). The CPR quality was similar between the two groups. However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042). CONCLUSIONS This brief DACPR training in addition to standard CPR training can result in a modest improvement in the time to initiate CPR. Future studies are now required to examine the effect of DACPR training on survival of sudden CA.",2020,"However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042). ","['66 participants, 59 completed the simulation (30 from the DACPR group and 29 from the Standard group', 'Participants who were non-health care professionals with no CPR training within 1 year prior to this study were recruited from Nara Medical University Hospital']","['10-min dispatch-assisted cardiopulmonary resuscitation training', 'DACPR', 'standard CPR training', 'DACPR training', 'bystander cardiopulmonary resuscitation (CPR', '90-min adult basic life support (BLS) training course groups: DACPR group (standard adult BLS training plus an additional 10-min DACPR training) or Standard group (standard adult BLS training only', 'simple DACPR training']","['median time interval between call receipt and the first dispatch-assisted compression', 'CPR quality']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0642676,"However, the median time interval between call receipt and the first dispatch-assisted compression was faster in the DACPR group (108 s vs 129 s, p = 0.042). ","[{'ForeName': 'Hidetada', 'Initials': 'H', 'LastName': 'Fukushima', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan. hidetakarina@gmail.com.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Asai', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}, {'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Seki', 'Affiliation': 'Department of Emergency, Nara Prefecture General Medical Center, Shichijo-Nishimachi 2-897-5, Nara City, 630-8581, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolstad', 'Affiliation': 'Clinical English, Nara Medical University, Shijo-cho 840, Kashihara City, Nara, 634-8522, Japan.'}]",International journal of emergency medicine,['10.1186/s12245-020-00287-9'] 2881,32527232,Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial.,"BACKGROUND Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients. METHODS This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events. DISCUSSION This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective. TRIAL REGISTRATION The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463. Registration was performed before recruitment was initiated.",2020,"BACKGROUND Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","['Patients aged 18 to 74\u2009years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5\u2009h of their clinical onsets, are eligible for participation in this study', 'AIS patients treated with rtPA', 'multicenter trial with an estimated sample size of 306 cases, starting in January 2018', 'patients with acute ischemic stroke (AIS', 'acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE']","['glibenclamide combined with rtPA', 'Glibenclamide (US adopted name, glyburide', 'glibenclamide or placebo', 'recombinant tissue plasminogen activator (rtPA', 'glibenclamide', 'placebo']","['30-day mortality and early neurological deterioration', 'modified Rankin Scale of 0 to 2', 'safety and efficacy', 'Safety and efficacy', 'cardiac- and glucose-related serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1549653', 'cui_str': 'Adopted name'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.247589,"BACKGROUND Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability.","[{'ForeName': 'Kaibin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China.'}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Heyuan People's Hospital, Heyuan, China.""}, {'ForeName': 'Guangning', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Huadu district People's Hospital, Guangzhou, China.""}, {'ForeName': 'Saijun', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Wenguo', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Maoming Hospital of Traditional Chinese Medicine, Maoming, China.'}, {'ForeName': 'Guoshuai', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Haikou People's Hospital, Haikou, China.""}, {'ForeName': 'Guohu', 'Initials': 'G', 'LastName': 'Weng', 'Affiliation': 'Department of Neurology, Hainan Hospital of Traditional Chinese Medicine, Haikou, China.'}, {'ForeName': 'Pingyan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Suyue', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Nanfang Hospital, Southern Medical University, Guangzhou North Avenue 1838#, Guangzhou, 510515, China. pansuyue82@126.com.'}]",BMC neurology,['10.1186/s12883-020-01823-z'] 2882,32527261,Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities.,"BACKGROUND Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-to-door including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households. METHODS A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants' experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically. RESULTS The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms. CONCLUSION Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care.",2020,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[""participants' experiences with HIVST, Interviews (n\u2009=\u200940), observations (n\u2009=\u200922) and group discussions (n\u2009=\u200991) with household members and CHiPs were conducted"", ' trained Community HIV care provider (CHiPs) visited households and offered individuals aged\u2009≥\u200916 and eligible for an offer of HTS the choice of HIV testing using', 'households: experiences from four Zambian HPTN 071 (PopART) urban communities', 'Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities']","['HIVST', 'PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST', 'PopART intervention', 'HIV self-testing kits (HIVST', 'HIVST or routine door-to-door HTS (finger-prick RDT']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]",[],,0.0271676,"The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs.","[{'ForeName': 'Chiti', 'Initials': 'C', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia. Bwalya@zambart.org.zm.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Lwiindi', 'Initials': 'L', 'LastName': 'Gwanu', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Able', 'Initials': 'A', 'LastName': ""Hang'andu"", 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Mulubwa', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwelwa', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Mwinga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS research and therapy,['10.1186/s12981-020-00287-y'] 2883,32527268,Neurophysiological signatures of hand motor response to dual-transcranial direct current stimulation in subacute stroke: a TMS and MEG study.,"BACKGROUND Dual transcranial direct current stimulation (tDCS) to the bilateral primary motor cortices (M1s) has potential benefits in chronic stroke, but its effects in subacute stroke, when behavioural effects might be expected to be greater, have been relatively unexplored. Here, we examined the neurophysiological effects and the factors influencing responsiveness of dual-tDCS in subacute stroke survivors. METHODS We conducted a randomized sham-controlled crossover study in 18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4 weeks after stroke onset and 14 matched healthy controls. Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2 mA for 20mins) and sham dual-tDCS on separate days, with concurrent paretic [left for controls] hand exercise. Using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG), we recorded motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations before and immediately after tDCS. RESULTS Stroke survivors had decreased excitability in ipsilesional M1 with a relatively excessive transcallosal inhibition from the contralesional to ipsilesional hemisphere at baseline compared with controls, as quantified by decreased MEPs and increased iSP duration. Dual-tDCS led to increased MEPs and decreased iSP duration in ipsilesional M1. The magnitude of the tDCS-induced MEP increase in stroke survivors was predicted by baseline contralesional-to-ipsilesional transcallosal inhibition (iSP) ratio. Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors. No significant adverse effects were observed during or after dual-tDCS. CONCLUSIONS Task-concurrent dual-tDCS in subacute stroke can safely and effectively modulate bilateral M1 excitability and inter-hemispheric imbalance and also movement-related α-activity.",2020,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","['subacute stroke survivors', '18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4\u2009weeks after stroke onset and 14 matched healthy controls', 'subacute stroke', 'Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2\u2009mA for 20mins) and']","['Dual transcranial direct current stimulation (tDCS', 'Task-concurrent dual-tDCS', 'transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG', 'concurrent paretic [left for controls] hand exercise', 'dual-transcranial direct current stimulation', 'sham dual-tDCS']","['α-band activity in ipsilesional M1', 'stroke survivors', 'upper limb score', 'bilateral M1 excitability and inter-hemispheric imbalance', 'excitability in ipsilesional M1', 'adverse effects', 'motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations', 'iSP duration']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}]",18.0,0.0623601,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","[{'ForeName': 'I-Ju', 'Initials': 'IJ', 'LastName': 'Kuo', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tang', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Yun-An', 'Initials': 'YA', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shuen-Chang', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Wei-Kuang', 'Initials': 'WK', 'LastName': 'Liang', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Zich', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan. ihlee@vghtpe.gov.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00706-1'] 2884,32527344,[Clinical study of artesunate in the treatment of coronavirus disease 2019].,"OBJECTIVE To discuss the effective of artesunate in the treatment of coronavirus disease 2019 (COVID-19). METHODS Using prospective method, the 43 cases of confirmed COVID-19 patients in Nanning Fourth People's Hospital from January 22nd to February 15th in 2020 were enrolled and divided into routine treatment group (n = 25) and artesunate treatment group (n = 18) by odd-even rule after admission. According to the guidelines, the routine treatment group was recommended to receive lopinavir/ritonavir 500 mg + α-aerosolized interferon 500×10 4 U, twice daily; the artesunate treatment group was given artesunate 60 mg, twice daily besides the routine treatment, for 10 days in both groups. During the treatment period, the pharynx swab test of 2019 novel coronavirus (2019-nCoV) nucleic acid was carried out every 2 days, and the routine blood test, liver and kidney functions, blood coagulation function and myocardial enzymes were re-examined. Chest CT was checked every 3 days after the treatment, and re-examined every 5 days after the condition was improved. The routine blood test and biochemical results of two groups were observed, and the efficacy evaluation was performed by monitoring the time for significant improvement of symptoms, negative conversion time of throat swab virus nucleic acid, lung lesion absorption time, adverse drug reactions and the length of hospital stay of the two groups. RESULTS There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment. In artesunate treatment group, the time for significant improvement of symptoms (days: 3.33±1.91 vs. 4.84±2.19), negative conversion time of 2019-nCoV nucleic acid (days: 4.72±2.16 vs. 6.68±3.76), lung lesion absorption starting time (days: 5.39±2.36 vs. 7.48±3.78), lung lesion absorption greater than 70% time (days: 14.11±4.16 vs. 17.04±4.42) and the length of hospital stay (days: 16.56±3.71 vs. 18.04±3.97) were significantly shorter than those in routine treatment group, with significant differences (all P < 0.05). The incidence of adverse drug reactions in two groups had no significant difference (72.2% vs. 80.0%, P > 0.05). CONCLUSIONS Artesunate can shorten the treatment time of COVID-19, improve prognosis and eliminate pathogens, with fewer adverse reactions and a good application prospect.",2020,"There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment.","[""43 cases of confirmed COVID-19 patients in Nanning Fourth People's Hospital from January 22nd to February 15th in 2020 were enrolled and divided into routine treatment group (n = 25) and"", 'coronavirus disease 2019 (COVID-19', 'coronavirus disease 2019']","['lopinavir/ritonavir 500 mg + α-aerosolized interferon 500×10 4 U, twice daily; the artesunate treatment group was given artesunate 60 mg, twice daily besides the routine treatment', 'artesunate', '2019 novel coronavirus (2019-nCoV) nucleic acid', 'artesunate treatment']","['negative conversion time of 2019-nCoV nucleic acid (days', 'gender, age, body weight, routine blood test and biochemical results', 'Chest CT', 'symptoms, negative conversion time of throat swab virus nucleic acid, lung lesion absorption time, adverse drug reactions and the length of hospital stay of the two groups', 'length of hospital stay', 'lung lesion absorption starting time', 'lung lesion absorption', 'incidence of adverse drug reactions']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301880', 'cui_str': 'Start time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2020.0,0.0199004,"There were no significant differences between the two groups in terms of gender, age, body weight, routine blood test and biochemical results before treatment.","[{'ForeName': 'Yanrong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Zhouhua', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Pediatrics, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Qingdong', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Shiji', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': ""Department of Intensive Care Unit, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Lianshao', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': ""Department of Tuberculosis, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China.""}, {'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Gong', 'Affiliation': ""Department of Nursing, Nanning Fourth People's Hospital, Affiliated Infectious Disease Hospital of Guangxi Medical University, Nanning 530023, Guangxi Zhuang Autonomous Region, China. Corresponding author: Wu Fengyao, Email: wufengyao@126.com.""}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200312-00412'] 2885,32527346,[Effect of Xuebijing injection on inflammatory markers and disease outcome of coronavirus disease 2019].,"OBJECTIVE To observe the influence of Xuebijing injection on the inflammatory markers and prognosis of coronavirus disease 2019 (COVID-19) patients. METHODS Sixty severe COVID-19 patients admitted to Changsha Public Health Treatment Center (North Hospital of the First Hospital of Changsha City) from January to March in 2020 were randomly divided into routine treatment group, Xuebijing 50 mL group and Xuebijing 100 mL group, with 20 cases in each group. The routine treatment group was treated according to the National Health Commission's guide for COVID-19. On the basis of conventional treatment, Xuebijing injection was injected by 50 mL twice a day for 7 days in Xuebijing 50 mL group, while by 100 mL twice a day for 7 days in Xuebijing 100 mL group. The blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), acute physiology and chronic health evaluation II (APACHE II) score, 2019 novel coronavirus (2019-nCoV) nucleic acid test and disease classification of three groups before and 8 days after treatment were observed. RESULTS (1) After treatment, the white blood cell count (WBC) and lymphocyte count (LYM) of three groups increased, meanwhile CRP and ESR decreased. Compared with routine treatment group, the WBC count of Xuebijing 100 mL group after treatment significantly increased (×10 9 /L: 7.12±0.55 vs. 5.67±0.51, P < 0.05), and the levels of CRP and ESR in Xuebijing 50 mL and 100 mL groups significantly decreased [CRP (mg/L): 32.3±4.6, 28.0±6.2 vs. 37.3±5.9; ESR (mm/1 h): 45.9±5.7, 40.5±7.4 vs. 55.3±6.6, all P < 0.05]. Compared with Xuebijing 50 mL group, the increase of WBC, and the decrease of CRP and ESR were more significant in Xuebijing 100 mL group [WBC (×10 9 /L): 7.12±0.55 vs. 5.82±0.49, CRP (mg/L): 28.0±6.2 vs. 32.3±4.6, ESR (mm/1 h): 40.5±7.4 vs. 45.9±5.7, all P < 0.05]. (2) After treatment, the APACHE II score of three groups decreased. In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05). After treatment, the 2019-nCoV nucleic acid test in three groups partly turned negative, with 9 cases in routine treatment group, 8 cases in Xuebijing 50 mL group and 9 cases in Xuebijing 100 mL group, without significant difference (P > 0.05). The conditions of patients in the three groups were improved after treatment, among them, 8 cases in the routine treatment group were transformed into common type, 1 case into critical type; 9 cases and 12 cases of Xuebijing 50 mL group and 100 mL group were transformed into common type respectively. Xuebijing 100 mL group was improved more obviously than Xuebijing 50 mL group and routine treatment group (both P < 0.05). CONCLUSIONS The Xuebijing injection can effectively improve the inflammatory markers and prognosis of severe COVID-19 patients.",2020,"In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05).","['Sixty severe COVID-19 patients admitted to Changsha Public Health Treatment Center (North Hospital of the First Hospital of Changsha City) from January to March in 2020', 'coronavirus disease 2019 (COVID-19) patients']","['Xuebijing injection', 'routine treatment group, Xuebijing 50 mL group and Xuebijing 100 mL group']","['CRP and ESR', 'blood routine test, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), acute physiology and chronic health evaluation II (APACHE II) score, 2019 novel coronavirus (2019-nCoV) nucleic acid test and disease classification', 'WBC', 'white blood cell count (WBC) and lymphocyte count (LYM', 'WBC count', 'APACHE II score', 'levels of CRP and ESR', '2019-nCoV nucleic acid test', 'meanwhile CRP and ESR', 'inflammatory markers and disease outcome']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0235473,"In Xuebijing 100 mL group, the APACHE II score after treatment was significantly lower than those in routine treatment and Xuebijing 50 mL groups (12.3±1.5 vs. 16.5±1.6, 15.9±1.4, both P < 0.05).","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Respiratory Medicine, the First Hospital of Changsha City, Changsha 410000, Hunan, China. Corresponding author: Zhou Zhiguo, Email: 15874863866@163.com.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Dixuan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200406-00386'] 2886,32527349,[A clinical study on the determination of cuff pressure in artificial airway by minimum air leakage method].,"OBJECTIVE To compare the cuff pressure and leakage volume and the related complications of filling the tracheal tube cuff by minimum air leakage method and cuff pressure manometer method after endotracheal intubation, so as to provide theoretical basis for patients who was intubated to obtain appropriate cuff pressure. METHODS A prospective randomized controlled study was conducted. 100 patients admitted to the department of critical care medicine of the Fifth Center Hospital in Tianjin from December 2015 to June 2019 were enrolled. According to the random number table method, the patients were divided into the experimental group and control group, with 50 patients in each group. After successful endotracheal intubation, all patients were placed in a supine position with the head of the bed raised by 30 degree angle. The experimental group used the minimum air leakage method, and used the cuff pressure manometer to obtain the cuff pressure. In the control group, cuff pressure was maintained at 25-30 cmH 2 O (1 cmH 2 O = 0.098 kPa). Parameters such as cuff pressure and ventilator leakage volume at the beginning and 4 hours, 8 hours after the inflation were compared between the two groups, as well as the incidence of ventilation-associated pneumonia (VAP) and airway complications after extubation. RESULTS Among the 100 cases, 53 were males and 47 were females. The age ranged from 23 to 87 years old, with an average of (68.53±8.46) years old. The intubation time ranged from 1 to 16 days. (1) At 4 hours and 8 hours after inflation, the cuff pressures of the two groups were lower than that of the first time of inflation, and the air leakage of the ventilator increased gradually with the extension of time. Compared with the control group, cuff pressures at each time point in the experimental group were significantly higher than those in the control group [mmHg (1 mmHg = 0.133 kPa): 33.72±9.14 vs. 25.68±5.26 at 0 hour, 30.54±7.81 vs. 24.35±4.93 at 4 hours, 26.57±5.64 vs. 22.42±4.14 at 8 hours, all P < 0.05], and ventilator leakage volumes were smaller than those in the control group (mL: 25.57±8.51 vs. 34.65±9.47 at 0 hour, 40.54±8.51 vs. 60.34±7.85 at 4 hours, both P < 0.05). (2) The incidence of VAP in the experimental group was significantly lower than that in the control group (4% vs. 10%, P < 0.05). There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05). CONCLUSIONS The optimal cuff pressure is very important for preventing VAP and reducing airway complications. The minimum air leakage method makes the clinical obtained endotracheal intubation cuff pressure more accurately, with less air leakage, safe and effective, and it is worthy of clinical promotion.",2020,"There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05). ","['The age ranged from 23 to 87 years old, with an average of (68.53±8.46) years old', '100 cases, 53 were males and 47 were females', '100 patients admitted to the department of critical care medicine of the Fifth Center Hospital in Tianjin from December 2015 to June 2019 were enrolled', 'patients who was intubated to obtain appropriate cuff pressure']",['tracheal tube cuff by minimum air leakage method and cuff pressure manometer method after endotracheal intubation'],"['incidence of ventilation-associated pneumonia (VAP) and airway complications', 'cuff pressure', 'cuff pressure and ventilator leakage volume', 'hoarseness', 'intubation time', 'air leakage of the ventilator', 'ventilator leakage volumes', 'incidence of VAP', 'incidence of other airway complications', 'cuff pressures', 'cuff pressure and leakage volume', 'tracheal esophageal fistula']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0014856', 'cui_str': 'Esophageal fistula'}]",100.0,0.0137986,"There was no statistically significant difference in the incidence of other airway complications between the experimental group and control group (airway mucosal edema: 14% vs. 12%, ulcer: 8% vs. 6%, tracheal esophageal fistula: 0% vs. 0%, hoarseness: 4% vs. 6%, cough: 30% vs. 34%, sore throat: 28% vs. 32%, tracheal softening: 0% vs. 0%, cuff rupture: 10% vs. 8%, all P > 0.05). ","[{'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Teng', 'Affiliation': 'Department of Critical Care Medicine, the Fifth Center Hospital in Tianjin, Tianjin 300457, China. Corresponding author: Cheng Xiuling, Email: tenghy_wzxyy@sina.com.'}, {'ForeName': 'Xiuling', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Wanjie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yanlei', 'Initials': 'Y', 'LastName': 'Zuo', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hua', 'Affiliation': ''}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200122-00143'] 2887,32527353,[Effect of Xuebijing on inflammatory response and prognosis in patients with septic shock].,"OBJECTIVE To study the effect of Xuebijing on inflammatory response and prognosis in patients with septic shock. METHODS A prospective randomized controlled study was conducted. Eighty septic shock patients admitted to department of critical care medicine of the First Affiliated Hospital of Zhengzhou University from January to December in 2019 were enrolled. The enrolled patients were divided into Xuebijing group and control group by randomized number table method, with 40 cases in each group. Both groups were strictly followed the guidelines for the diagnosis and treatment of septic shock to take comprehensive treatment measures against sepsis. On this basis, Xuebijing group received intravenous 100 mL Xuebijing injection twice a day for 7 days. Baseline data of enrolled patients were recorded. The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment. Mechanical ventilation time, the length of intensive care unit (ICU) stay, total hospitalization time and 28-day mortality were recorded. The differences of every indicator between the two groups were compared. Independent risk factors affecting patient prognosis were analyzed by binary Logistic regression. RESULTS (1) There was no significant difference in baseline data such as gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure score (SOFA) between the two groups. (2) The levels of serum inflammatory factors in both groups showed a decreasing trend after treatment. Compared with the control group, IL-6 and HBP in the Xuebijing group significantly decreased on day 7 [IL-6 (ng/L): 66.20 (16.34, 163.71) vs. 79.81 (23.95, 178.64), HBP (ng/L): 95.59 (45.23, 157.37) vs. 132.98 (73.90, 162.05), both P < 0.05]; on day 10, PCT, CRP, IL-6 and HBP significantly decreased [PCT (μg/L): 1.14 (0.20, 3.39) vs. 1.31 (0.68, 4.21), CRP (mg/L): 66.32 (19.46, 115.81) vs. 89.16 (20.52, 143.76), IL-6 (ng/L): 31.90 (13.23, 138.74) vs. 166.30 (42.75, 288.10), HBP (ng/L): 62.45 (29.17, 96.51) vs. 112.33 (58.70, 143.96), all P < 0.05]. (3) Compared with the control group, mechanical ventilation time and the length of ICU stay were significantly shortened and the total hospitalization expenses were significantly reduced in Xuebijing group [mechanical ventilation time (hours): 57.0 (0, 163.5) vs. 168.0 (24.0, 282.0), the length of ICU stay (days): 8.80±4.15 vs. 17.13±7.05, the total hospitalization expenses (ten thousand yuan): 14.55±7.31 vs. 20.01±9.86, all P < 0.05]. There was no significant difference in 28-day mortality and the total hospitalization time [28-day mortality: 37.5% vs. 35.0%, the total hospitalization time (days): 13.05±8.44 vs. 18.30±9.59, both P > 0.05]. (4) Patients were divided into death and survival groups according to the prognosis, and univariate analysis showed that white blood cell (WBC), neutrophil percentage (NEU%), CRP, lactic acid (Lac), APACHE II score, IL-6, HBP were the factors influencing the prognosis of patients. The above indicators were further analyzed by Logistic regression, which showed that CRP, IL-6, and APACHE II score were independent risk factors for prognosis [odds ratio (OR) was 1.007, 1.828, 1.229, all P < 0.05]. CONCLUSIONS Combined with Xuebijing to treat septic shock can reduce the body's inflammatory response to a certain extent, thereby reducing the time of mechanical ventilation, shortening the stay of ICU and reducing the total cost of hospitalization. But it cannot reduce the 28-day mortality of patients with septic shock.",2020,"The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment.","['Eighty septic shock patients admitted to department of critical care medicine of the First Affiliated Hospital of Zhengzhou University from January to December in 2019 were enrolled', 'patients with septic shock']",['Xuebijing'],"['length of ICU stay', 'total hospitalization time', 'IL-6 and HBP', 'white blood cell (WBC), neutrophil percentage (NEU%), CRP, lactic acid (Lac), APACHE II score, IL-6, HBP', 'total cost of hospitalization', 'levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP', 'mechanical ventilation time and the length of ICU stay', 'PCT, CRP, IL-6 and HBP', 'CRP, IL-6, and APACHE II score', 'levels of serum inflammatory factors', '28-day mortality', 'Mechanical ventilation time, the length of intensive care unit (ICU) stay, total hospitalization time and 28-day mortality', 'IL-6', '28-day mortality and the total hospitalization time [28-day mortality', 'total hospitalization expenses', 'baseline data such as gender, age, infection site, acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure score (SOFA']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C2933944', 'cui_str': 'Xuebijing'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0054878', 'cui_str': 'cationic antimicrobial protein CAP 37'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1171400', 'cui_str': 'Neutrophil percentage'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C4758051', 'cui_str': 'APACHE II (Acute Physiology and Chronic Health Evaluation II) score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}]",80.0,0.0764107,"The levels of interleukin-6 (IL-6), procalcitonin (PCT), C-reactive protein (CRP) and heparin binding protein (HBP) were measured before treatment and 3, 7 and 10 days after treatment.","[{'ForeName': 'Rongqing', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Critical Care Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China. Corresponding author: Sun Rongqing, Email: rongqing.sun@126.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Fangjie', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200401-00333'] 2888,32527501,[Influence of methylprednisolone on the reversal time of sugammadex: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES Sugammadex is a modified gamma-cyclodextrin that reverses the effects of aminosteroidal neuromuscular blocking agents. Likewise, some steroid molecules, such as toremifene, fusidic acid, and flucloxacillin, can also be encapsulated by sugammadex. Methylprednisolone, which is a synthetic steroid used commonly for airway oedema prophylaxis, can also be encapsulated by sugammadex. The objective of this study was to compare the recovery times of sugammadex for reversing rocuronium-induced moderate neuromuscular blockade in those who received intraoperative 1 mg.kg -1 methylprednisolone or saline. METHOD This single-centered, randomized, controlled, prospective study included 162 adult patients undergoing elective ear-nose-throat procedures (aged from 18-65, an ASA physical status I-II, a BMI less than 30 kg.m -2 , and not taking steroid drug medication) with propofol, remifentanyl, rocuronium and sevoflurane. Neuromuscular monitoring was performed using calibrated acceleromyography. The Control Group (Group C) received 5 mL of saline, while the Methylprednisolone Group (Group M) received 1 mg.kg -1 of methylprednisolone in 5mL of saline just after induction. After the completion of surgery, regarding the TOF count, two reappeared spontaneously and 2 mg.kg -1 sugammadex was administered to all patients. Recovery of the TOF ratio to 0.9 was recorded for both groups, and the estimated recovery time to reach a TOF ratio (TOFr) of 0.9 was the primary outcome of the study. RESULTS Median time to TOFr = 0.9 was for 130.00 s (range of 29-330) for Group C and 181.00 s (100-420) for Group M (p < 0.001). The differences between the two groups were statistically significant. CONCLUSION When using 2 mg.kg -1 of sugammadex to reverse rocuronium-induced neuromuscular blockade in patients who received 1 mg.kg -1 of intraoperative methylprednisolone, demonstrated delayed recovery times.",2020,"The differences between the two groups were statistically significant. ","['162 adult patients undergoing elective ear-nose-throat procedures (aged from 18-65, an ASA physical status I-II, a BMI less than 30 kg.m']","['intraoperative 1 mg.kg -1 methylprednisolone or saline', '5 mL of saline, while the Methylprednisolone', 'methylprednisolone', 'propofol, remifentanyl, rocuronium and sevoflurane', 'Methylprednisolone']","['delayed recovery times', 'TOF count', 'estimated recovery time to reach a TOF ratio (TOFr', 'TOF ratio', 'reversal time of sugammadex']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}]",162.0,0.465584,"The differences between the two groups were statistically significant. ","[{'ForeName': 'Merve Hayriye', 'Initials': 'MH', 'LastName': 'Kocaoğlu', 'Affiliation': 'Turkish Ministry of Health Ankara 29 Mayis State Hospital, Department of Anesthesiology and Intensive Care, Ankara, Turkey. Electronic address: mervearal@yahoo.com.'}, {'ForeName': 'Başak Ceyda', 'Initials': 'BC', 'LastName': 'Meço', 'Affiliation': 'Ankara University Faculty of Medicine, Department of Anesthesiology and Intensive Care, Ankara, Turkey.'}, {'ForeName': 'Menekşe', 'Initials': 'M', 'LastName': 'Özçelik', 'Affiliation': 'Ankara University Faculty of Medicine, Department of Anesthesiology and Intensive Care, Ankara, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Batislam', 'Affiliation': 'Ankara University Faculty of Medicine, Department of Anesthesiology and Intensive Care, Ankara, Turkey.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.01.002'] 2889,32527511,Initial testing of a computer-based simulation training module to support clinicians' acquisition of CBT skills for substance use disorder treatment.,"Cognitive behavioral therapy (CBT) is one of the most common and effective treatments for substance use disorders (SUD); however, effective delivery of CBT depends on a wide variety of nuanced skills that require practice to master. We created a computer-based simulation training system to support the development of necessary skills for student trainees to be able to apply CBT effectively for clients with SUDs. CBT: Introducing Cognitive Behavioral Therapy is an interactive, role-play simulation that provides opportunities for clinician trainees to hone their skills through repeated practice and real-time feedback before application in a clinical setting. This is the first study that tests whether such a simulation improves trainee skills for the treatment of clients with SUDs. Graduate students (N = 65; social work, clinical psychology) completed standardized patient (SP) interviews, were randomized to the simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline. Using general linear models, results indicated a significant time x group effect, with students assigned to the simulation training program showing greater improvement in ""extensiveness"" and ""skillfulness"" ratings across three skill categories: general agenda setting (p = .03), explaining CBT concepts (p = .007), and understanding of CBT concepts (p = .001). However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024). No changes in extensiveness or skillfulness of motivational interviewing (MI) style were observed. This pilot test of CBT: Introducing Cognitive Behavioral Therapy offers support for use of this novel technology as a potential approach to scale up CBT training for students, and perhaps clinicians, counseling people with SUDs.",2020,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024).","['students, and perhaps clinicians, counseling people with SUDs', 'clients with SUDs', 'Graduate students (N\xa0=\xa065; social work, clinical psychology) completed standardized patient (SP) interviews']","['Cognitive behavioral therapy (CBT', 'CBT', 'simulation training program or manual comparison condition (Project MATCH manual), and completed SP interviews three months post-baseline']","['extensiveness or skillfulness of motivational interviewing (MI) style', 'extensiveness"" and ""skillfulness"" ratings', 'trainee skills']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0033912', 'cui_str': 'Clinical Psychology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439795', 'cui_str': 'Extensiveness'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]",65.0,0.013923,"However, manual comparison participants showed greater improvement than simulation trainees in ""assessing primary drug use"" (p range  = .013-.024).","[{'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America. Electronic address: nmastrol@binghamton.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Humm', 'Affiliation': 'SIMmersion, LLC, 8681 Robert Fulton Drive #E, Columbia, MD 21046, United States of America.'}, {'ForeName': 'Callon M', 'Initials': 'CM', 'LastName': 'Williams', 'Affiliation': 'Binghamton University, College of Community and Public Affairs, PO Box 6000, Binghamton, NY 13902, United States of America.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, Temple Medical Center, 40 Temple St., Suite 6C, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hoadley', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Magill', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, School of Public Health, Box G S-121-5, Providence, RI 02912, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108014'] 2890,32527676,Virtual reality based cognitive behavioral therapy for paranoia: Effects on mental states and the dynamics among them.,"BACKGROUND Negative affective processes may contribute to maintenance of paranoia in patients with psychosis, and vice versa. Successful treatment may break these pathological symptom networks. This study examined whether treatment with virtual reality based cognitive behavioral therapy (VR-CBT) for paranoia influences momentary affective states, and whether VR-CBT changes the adverse interplay between affective states and paranoia. METHODS Patients with a psychotic disorder (n = 91) were randomized to 16-session VR-CBT or treatment as usual (TAU). With the experience sampling method (structured diary technique) mental states were assessed for 6-10 days at baseline, posttreatment and 6-month follow-up. Multilevel analysis were performed to establish treatment effects and time-lagged associations between mental states, that were visualized with networks of mental states. RESULTS Average levels of paranoia (feeling suspicious [b = -032., p = .04], disliked [b = -49., p < .01] and hurt [b = -0.52, p < .01]) and negative affect (anxious [b = -0.37, p = .01], down [b = -0.33, p = .04] and insecure [b = -0.17, p = .03) improved more after VR-CBT than TAU, but positive affect did not. Baseline mental state networks had few significant connections, with most stable connections being autocorrelations of mental states. The interplay between affective states and paranoia did not change in response to treatment. A trend reduction in average intranode connections (autocorrelations) was found after VR-CBT (b = -0.07, p = .08), indicating that mental states reinforce themselves less after treatment. CONCLUSIONS VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other. Findings do suggest that as a result of treatment mental states regain flexibility.",2020,"VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other.","['patients with psychosis, and vice versa', 'paranoia', 'Patients with a psychotic disorder (n\u202f=\u202f91']","['16-session VR-CBT or treatment as usual (TAU', 'Virtual reality based cognitive behavioral therapy', 'virtual reality based cognitive behavioral therapy (VR-CBT']","['average intranode connections (autocorrelations', 'paranoid symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",91.0,0.025786,"VR-CBT reduced paranoid symptoms and lowered levels of negative affect in daily life, but did not affect the extent to which mental states influenced each other.","[{'ForeName': 'Chris N W', 'Initials': 'CNW', 'LastName': 'Geraets', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands. Electronic address: c.n.w.geraets@umcg.nl.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Snippe', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), the Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'van Beilen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands.'}, {'ForeName': 'Roos M C A', 'Initials': 'RMCA', 'LastName': 'Pot-Kolder', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, the Netherlands; VU University and Amsterdam Public Mental Health research institute, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion regulation (ICPE), the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, the Netherlands; VU University and Amsterdam Public Mental Health research institute, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Veling', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry, the Netherlands; Parnassia Psychiatric Institute, The Hague, the Netherlands; Maastricht University, Department of Psychiatry and Neuropsychology, Maastricht, the Netherlands.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.047'] 2891,32527692,Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.,"BACKGROUND In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis. DESIGN, SETTING, AND PARTICIPANTS We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Predictors of the primary outcome of overall survival were estimated using the Kaplan-Meier method. Long-term adverse events over time were analyzed. RESULTS AND LIMITATIONS At the 5-yr data cutoff, 1382 of 1717 (80%) men had died. Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively. Median overall survival was 36 mo (95% CI 34-38) in the enzalutamide arm versus 31 mo (95% CI 29-34) in the placebo arm, with a median follow-up of 69 mo. Prognostic modeling showed 5-yr survival rates of 42%, 24%, and 5% for low-, intermediate-, and high-risk groups, respectively. Greater degrees of confirmed prostate-specific antigen declines (≤3 mo) were associated with greater 5-yr survival. A higher incidence of fatal treatment-emergent adverse events was observed with enzalutamide (6.9% vs 3.8%), with an increase in fatal cardiovascular events (1.6% vs 0.4%). CONCLUSIONS With >5 yr of follow-up, enzalutamide continued to demonstrate improved survival in patients with mCRPC despite crossover and multiple subsequent effective therapies, balanced against a slightly higher rate of fatal cardiovascular events. PREVAIL is registered on ClinicalTrials.gov as NCT01212991. PATIENT SUMMARY We report a maintained long-term survival benefit with enzalutamide and risks with >5 yr of enzalutamide treatment and follow-up in men with metastatic prostate cancer, and identify groups of men with widely different outcomes based on clinical factors.",2020,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","['n\u2009=\u2009693) arms', 'patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC', 'men with chemotherapy-naïve mCRPC from the enzalutamide (n\u2009=\u2009689) and', 'men with metastatic prostate cancer', 'Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer']","['placebo', 'enzalutamide', 'enzalutamide and risks with >5\u2009yr of enzalutamide', 'Enzalutamide']","['5-yr survival', 'Median overall survival', 'hazard of death', 'fatal treatment-emergent adverse events', '5-yr survival rates', 'overall survival', 'survival', 'died', 'rate of fatal cardiovascular events', 'fatal cardiovascular events']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.640042,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology and Urology, Duke Cancer Institute, Duke University, Durham, NC, USA. Electronic address: andrew.armstrong@duke.edu.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Division of Urology and Urologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Parli', 'Affiliation': 'Clinical Development, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Biostatistics, Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'van Os', 'Affiliation': 'Biostatistics, Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Hematology/Medical Oncology, OHSU Knight Cancer Institute Oregon Health & Science University, Portland, OR, USA.'}]",European urology,['10.1016/j.eururo.2020.04.061'] 2892,32533013,"Local tissue electrical parameters predict oral mucositis in HNSCC patients: A diagnostic accuracy double-blind, randomized controlled trial.","Oral Mucositis (OM) is a common adverse effect of head and neck squamous cell carcinoma (HNSCC) treatment. The purpose of this study was to investigate the significance of early changes in tissue electrical parameters (TEPs) in predicting the development of OM in HNSCC patients receiving radiation therapy (RT). The current study combined two study designs. The first was a case-control study. The control group comprised of RT patients who did not receive head and neck RT, and patients with HNSCC who received RT comprised the case group. In the second part of the study, the case group was included in a parallel cohort. A total of 320 patients were assessed for eligibility, and 135 patients were enrolled. Double blinding was performed, and neither the patients nor the care providers knew the measured parameters. The primary outcome was the detection of between-group changes in local TEPs over the follow-up period. The secondary outcome was the appearance of OM grades II, III, or IV and the predictive value of local TEPs in determining the incidence of OM after RT. The variables, impedance module, resistance, reactance, phase angle, and capacitance, were analyzed by the receiver operator curves (ROC). The case and control groups did not differ in demographic and clinical characteristics. Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups. Evaluation of TEPs in the first week of RT correlated with the development of OM lesions during cancer therapy. ROC analysis showed that local impedance module and resistance presented higher specificity than did other parameters in predicting OM. In conclusion, local tissue electrical parameters measured at the first RT week can be useful tools to predict oral mucositis.",2020,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","['HNSCC patients receiving radiation therapy (RT', 'A total of 320 patients were assessed for eligibility, and 135 patients were enrolled', 'head and neck squamous cell carcinoma (HNSCC', 'HNSCC patients']","['Radiation therapy', 'TEPs']","['local tissue electrical parameters', 'local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance', 'Oral Mucositis (OM', 'appearance of OM grades II, III, or IV and the predictive value of local TEPs', 'detection of between-group changes in local TEPs', 'variables, impedance module, resistance, reactance, phase angle, and capacitance', 'OM lesions']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",320.0,0.028312,"Radiation therapy increased the local impedance module, resistance, reactance, and phase angle and reduced the local tissue capacitance in both groups.","[{'ForeName': 'Gabriela Luize Guimarães', 'Initials': 'GLG', 'LastName': 'Sanches', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Agna Soares', 'Initials': 'AS', 'LastName': 'da Silva Menezes', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Laércio Ives', 'Initials': 'LI', 'LastName': 'Santos', 'Affiliation': 'Instituto Federal do Norte de Minas Gerais, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Cristina Paixão', 'Initials': 'CP', 'LastName': 'Durães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Larissa Lopes', 'Initials': 'LL', 'LastName': 'Fonseca', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcelo Perim', 'Initials': 'MP', 'LastName': 'Baldo', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'de Oliveira Faria', 'Affiliation': 'Department of Pathophysiology, Universidade Estadual de Montes Claros, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Luciano Alves', 'Initials': 'LA', 'LastName': 'de Araújo Andrade', 'Affiliation': 'Dilson Godinho Hospital, Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Petr Iakovlevitch', 'Initials': 'PI', 'LastName': 'Ekel', 'Affiliation': 'Pontifícia Universidade Católica de Minas Gerais, Programa de Pós-Graduação em Engenharia Elétrica, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Sérgio Henrique Sousa', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Institute of Agricultural Sciences, Universidade Federal de Minas Gerais (UFMG), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Maurício Batista', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Lucyana Conceição', 'Initials': 'LC', 'LastName': 'Farias', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'Marcos Flávio Silveira Vasconcelos', 'Initials': 'MFSV', 'LastName': ""D'Angelo"", 'Affiliation': 'Department of Computer Science, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil.'}, {'ForeName': 'André Luiz Sena', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Department of Dentistry, Universidade Estadual de Montes Claros, Minas Gerais, Montes Claros, Brazil. andreluizguimaraes@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-66351-9'] 2893,32533015,Influence of the long-term use of oral hygiene products containing stannous ions on the salivary microbiome - a randomized controlled trial.,"Oral hygiene products containing tin are suitable to prevent erosive tooth wear, yet effects on the oral microbiota are not known yet. Therefore, this study determined the salivary microbiome of 16 participants using products with stannous ions for three years (TG) compared with a control group (CG) to assess their influence on the microbiota. Participants were included in a randomized controlled clinical trial (RCT) with biannual visits. Illumina Miseq sequencing revealed as most abundant genera: Streptococcus (TG 14.3%; CG 13.0%), Veillonella (TG 11.3%; CG 10.9%), Prevotella (TG 7.0%; CG 9.8%), Haemophilus (TG 6.6%; CG 7.2%), Porphyromonas (TG 5.9%, CG 5.1%), Leptotrichia (TG 5.8%; CG 4.9%), Actinomyces (TG 4.0%; CG 4.6%) and Neisseria (TG 5.4%; CG 4.2%). Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years. The genus Prevotella was found in higher abundance in CG whereas Neisseria and Granulicatella, health-associated taxa, were found more abundantly in TG. Salivary microbiota after three years reflected a composition associated with oral health, hence continual use as a preventive measure for dental erosion can be considered safe and benefitting oral health for patients with a high risk of erosion.",2020,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","['patients with a high risk of erosion', '16 participants using products with stannous ions for three years (TG']","['control group (CG', 'oral hygiene products containing stannous']","['Beta-Diversity', 'Salivary microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",16.0,0.0518899,"Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years.","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Anderson', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. annette.anderson@uniklinik-freiburg.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schlueter', 'Affiliation': 'Division for Cariology, Department of Operative Dentistry and Periodontology, Medical Center- University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frese', 'Affiliation': 'Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Binder', 'Affiliation': 'Institute for Prevention and Cancer Epidemiology, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-66412-z'] 2894,32533085,Remote ischemic conditioning in active ulcerative colitis: An explorative randomized clinical trial.,"Remote ischemic conditioning (RIC) by repetitive brief periods of limb ischemia and reperfusion renders organs more resistant to ischemic injury. The protection is partly through down-regulation of the inflammatory response. Our aim was to investigate the clinical and anti-inflammatory effects of RIC in patients with active ulcerative colitis (UC). We included 22 patients with active UC in this explorative, randomized, sham-controlled clinical trial. The patients were randomly assigned 1:1 to RIC (induced in the arm through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff) once daily for 10 days. Outcome variables were measured at baseline and on day 11. When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC. The mRNA and miRNA expression profiles in the UC patients were measured by RNA sequencing and multiplexed hybridization, respectively, but were not significantly affected by RIC. We used the Langendorff heart model to assess activation of the organ protective mechanism induced by RIC, but could not confirm activation of the organ protective mechanism in the UC patients.",2020,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","['22 patients with active UC', 'active ulcerative colitis', 'patients with active ulcerative colitis (UC']","['5-min inflation and 5-min deflation of a blood-pressure cuff) or sham (incomplete inflation of the blood-pressure cuff', 'Remote ischemic conditioning', 'RIC', 'Remote ischemic conditioning (RIC']","['fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC', 'mRNA and miRNA expression profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",22.0,0.210465,"When compared with sham, RIC did not affect inflammation in the UC patients measured by fecal calprotectin, plasma C-reactive protein, Mayo Score, Mayo Endoscopic Subscore, Nancy Histological Index or inflammatory cytokines involved in UC and RIC.","[{'ForeName': 'Line E', 'Initials': 'LE', 'LastName': 'Godskesen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nichlas R', 'Initials': 'NR', 'LastName': 'Jespersen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Majken', 'Initials': 'M', 'LastName': 'Siersbæk', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Nielsen', 'Affiliation': 'Internal Medicine & Emergency Department, Odense University Hospital - Svendborg Sygehus, Svendborg, Denmark.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tjønnfjord', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøntved', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Madsen', 'Affiliation': 'Department of Pathology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Kjems', 'Affiliation': 'Interdisciplinary Nanoscience Center (iNANO), Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Hans E', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Krag', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark. aleksander.krag@rsyd.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-020-65692-9'] 2895,32533172,The Effects of a Vocabulary Intervention on Teaching Multiple-Meaning Words to Students Who Are d/Deaf and Hard of Hearing.,"Building vocabulary knowledge, especially breadth and depth of word meanings, is a crucial step in assisting students to read and comprehend print independently. A large body of research has documented the low reading achievement levels of a number of Deaf and hard-of-hearing (DHH) students. The goal of the present study was to examine the effects of a vocabulary intervention to teach 24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants). A total of 5 students with a profound hearing loss participated in the study. About 3 of 5 received the intervention, whereas two other students served as an additional control component and were administered the pretest and posttest only. The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention. In contrast, students who did not receive the intervention showed no significant improvement on the posttest.",2020,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"['Students', '24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants', '5 students with a profound hearing loss participated in the study']","['vocabulary intervention', 'Vocabulary Intervention']",['recognition and comprehension scores'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5.0,0.0168948,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"[{'ForeName': 'Faisl M', 'Initials': 'FM', 'LastName': 'Alqraini', 'Affiliation': 'Prince Sattam bin Abdulaziz University.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Paul', 'Affiliation': 'The Ohio State University.'}]",Journal of deaf studies and deaf education,['10.1093/deafed/enaa015'] 2896,32533819,Lisdexamfetamine alters BOLD-fMRI activations induced by odor cues in impulsive children.,"INTRODUCTION Lisdexamfetamine (LDX) is a drug used to treat ADHD/impulsive patients. Impulsivity is known to affect inhibitory, emotional and cognitive function. On the other hand, smell and odor processing are known to be affected by neurological disorders, as they are modulators of addictive and impulsive behaviors specifically. We hypothesize that, after LDX ingestion, inhibitory pathways of the brain would change, and complementary behavioral regulation mechanisms would appear to regulate decision-making and impulsivity. METHODS 20 children were studied in an aleatory crossover study. Imaging of BOLD-fMRI activity, elicited by olfactory stimulation in impulsive children, was performed after either LDX or placebo ingestion. RESULTS Findings showed that all subjects that underwent odor stimulation presented activations of similar intensities in the olfactory centers of the brain. This contrasted with inhibitory regions of the brain such as the cingulate cortex and frontal lobe regions, which demonstrated changed activity patterns and intensities. While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices. When comparing olfactory cues separately, pleasant food smells like chocolate seemed not to present large differences between the medicated and placebo scenarios, when compared to non-food-related smells. CONCLUSIONS We demonstrated that LDX, first, altered the inhibitory pathways of the brain, second, increased activity in large amounts of brain regions which were not activated by smell in drug-naïve patients, third, facilitated a complementary behavioral regulation mechanism, run by the cerebellum, which regulated decision-making and impulsivity in motor and frontal structures.",2020,"While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices.","['20 children', 'impulsive children']","['Lisdexamfetamine', 'Lisdexamfetamine (LDX', 'placebo']","['motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]","[{'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}]",20.0,0.0514171,"While some differences between the placebo and medicated states were found in motor areas, precuneus, cuneus, calcarine, supramarginal, cerebellum and posterior cingulate cortex, the main changes were found in frontal, temporal and parietal cortices.","[{'ForeName': 'Silvia S Hidalgo', 'Initials': 'SSH', 'LastName': 'Tobón', 'Affiliation': 'Imaging Department, Infant Hospital of Mexico, Federico Gómez. Address: Dr. Márquez 162, Colonia Doctores, 06720 Ciudad de México, CDMX. Mexico.'}, {'ForeName': 'Pilar Dies', 'Initials': 'PD', 'LastName': 'Suárez', 'Affiliation': 'Imaging Department, Infant Hospital of Mexico, Federico Gómez. Address: Dr. Márquez 162, Colonia Doctores, 06720 Ciudad de México, CDMX. Mexico.'}, {'ForeName': 'Eduardo Barragán', 'Initials': 'EB', 'LastName': 'Pérez', 'Affiliation': 'Neurology Department, Infant Hospital of Mexico, Federico Gómez. Address: Dr. Márquez 162, Colonia Doctores, 06720 Ciudad de México, CDMX. Mexico.'}, {'ForeName': 'Javier M Hernández', 'Initials': 'JMH', 'LastName': 'López', 'Affiliation': 'Faculty of Mathematical and Physical Sciences, Benemérita Universidad Autónoma de Puebla (BUAP). Address: Avenida San Claudio y 18 Sur, Colonia San Manuel, Edificio FM1-101B, Ciudad Universitaria, C.P. 72570, Puebla. Mexico.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'García', 'Affiliation': 'Department of Cardiac Sciences, Stephenson Cardiac Imaging Centre, Calgary University, Calgary, Canada. Address: University of Calgary, 2500 University Drive NW Calgary, AB T2N 1N4. Canada.'}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'de Celis Alonso', 'Affiliation': 'Faculty of Mathematical and Physical Sciences, Benemérita Universidad Autónoma de Puebla (BUAP). Address: Avenida San Claudio y 18 Sur, Colonia San Manuel, Edificio FM1-101B, Ciudad Universitaria, C.P. 72570, Puebla. Mexico.'}]",CNS & neurological disorders drug targets,['10.2174/1871527319666200613222502'] 2897,32533948,Corneal topography raw data classification using a convolutional neural network.,"PURPOSE We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of three categories: Normal , Keratoconus (KC) and History of refractive surgery (RS). DESIGN Retrospective machine learning experimental study. METHOD 3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation. 100 examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from 'Elevation against the anterior BFS', ´Elevation against the posterior BFS', 'Axial anterior curvature', and 'Pachymetry' maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity was calculated for the validation set. RESULTS Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):. Sensitivity and specificity were respectively 100% and 100% for Keratoconus, 100% and 99% (94.9% - 100%) for Normal examinations, and 98% (97.4% - 100%) and 100% for RS examinations. CONCLUSION Using combined corneal topography raw data with a convolutional neural network is a very effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, 25 Rue Manin, 75019 Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, 25 Rue Manin, 75019 Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, 25 Rue Manin, 75019 Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, 25 Rue Manin, 75019 Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians).'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005'] 2898,32533949,Omidenepag Isopropyl Versus Latanoprost in Primary Open-angle Glaucoma and Ocular Hypertension: ThePhase 3 AYAME Study.,"PURPOSE To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN Phase 3, randomized, investigator-masked, active-controlled, parallel-group, non-inferiority study (NCT02623738). METHODS After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9 AM, 1 PM, and 5 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The non-inferiority margin for OMDI versus latanoprost was 1.5 mmHg. Adverse events (AEs) were recorded. RESULTS Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients receiving OMDI or latanoprost had a mean diurnal IOP (±SD) of 23.78±1.73 mmHg and 23.40±1.51 mmHg, respectively. At week 4, least-squares mean (±SE) reduction in IOP from baseline with OMDI (-5.93±0.23 mmHg) was non-inferior to that of latanoprost (-6.56±0.22 mmHg; 95% confidence interval between groups: 0.01, 1.26). The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (23/94 [24.5%] versus 10/96 [10.4%]), corneal thickening (11/94 [11.7%] versus 1/96 [1.0%]), and punctate keratitis (0/94 versus 5/96 [5.2%]). No serious AEs were observed in either group and there were no discontinuations related to the study drug. CONCLUSIONS OMDI 0.002% was non-inferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated.",2020,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"['190 patients randomized, 189 had at least 1 post-baseline IOP measurement', 'Primary Open-angle Glaucoma and Ocular Hypertension', 'Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT']","['Omidenepag Isopropyl Versus Latanoprost', 'omidenepag isopropyl (OMDI', 'OMDI or latanoprost', 'OMDI 0.002% or latanoprost', 'latanoprost']","['mean diurnal IOP', 'conjunctival hyperemia ', 'serious AEs', 'corneal thickening', 'tolerated', 'punctate keratitis', 'mean diurnal IOP (±SD', 'Adverse events (AEs', 'Intraocular pressure (IOP']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C5139819', 'cui_str': 'omidenepag isopropyl'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3160915', 'cui_str': 'Corneal thickening'}, {'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}]",190.0,0.21222,The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen Inc., Emeryville, California. Electronic address: fenghe_lu@hotmail.com.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen Inc., Emeryville, California; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen Inc., Emeryville, California; Santen Pharmaceutical Co. Ltd., Osaka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.003'] 2899,32533985,Do different culture intervals (2 X 24 hours) after thaw of cleavage stage embryos affect pregnancy rates? A randomized controlled trial.,"The aim of the study was to evaluate whether selecting embryos for transfer after prolonged culture after thaw (18-24 h) has better pregnancy rates than selecting embryos for transfer after short culture after thaw (2-5 h). We performed a double-blinded, randomized, controlled trial, evaluating 388 patients submitted to ART treatment who had embryos frozen on day-2 and subsequently transferred. All patients received the same endometrial priming with estradiol valerate followed by vaginal progesterone. Patients were randomized for Frozen embryo transfer 2-5 h after thaw (Group D2) or 18-24 h after thaw (Group D2/D3). The main Outcome Measure was ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer. A total of 179 patients had embryos transferred 2-5 h after thaw and 209 patients had embryos transferred 18-24 h after thaw. The mean age in group D2 was 36 ± 4.4 and 36 ± 5.4 in group D2/D3. Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively. These results suggest that increasing the culture time of embryos in one day to improve selection before transfer does not increase ongoing pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT03381001.",2020,"Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively.","['179 patients had embryos transferred 2-5\u202fh after thaw and 209 patients had embryos transferred 18-24\u202fh after thaw', '388 patients submitted to ART treatment who had embryos frozen on day-2 and subsequently transferred']",['estradiol valerate followed by vaginal progesterone'],"['pregnancy rates', 'culture time of embryos', 'ongoing pregnancy rate (OPR', 'Ongoing pregnancy rate']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",388.0,0.268769,"Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively.","[{'ForeName': 'Laudislena', 'Initials': 'L', 'LastName': 'Colodetti', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Pinho de França', 'Affiliation': 'ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sampaio', 'Affiliation': 'ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil.'}, {'ForeName': 'Selmo', 'Initials': 'S', 'LastName': 'Geber', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil. Electronic address: selmogeber@origen.com.br.'}]",Cryobiology,['10.1016/j.cryobiol.2020.06.002'] 2900,32534040,Oral resveratrol supplementation improves Metabolic Syndrome features in obese patients submitted to a lifestyle-changing program.,"AIMS The aim of the present study was to evaluate the oral resveratrol effects associated with diet and physical training changes on anthropometric and biochemical parameters. MAIN METHODS 25 individuals aged from 30 to 60 years old; with Body Mass Index (BMI) ≥ 30 kg/m 2 were included in the study. Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol: Physical activity program + Diet + Resveratrol (RVS) (250 mg/day) for three months. Anthropometric and biochemical parameters were evaluated at baseline and after the treatment period. KEY FINDINGS The main findings showed that the resveratrol supplementation improved total cholesterol (TC), High-density Lipoprotein cholesterol (HDL-c), Very-low density Lipoprotein cholesterol (VLDL-c), urea, creatinine and albumin serum levels. SIGNIFICANCE These findings indicate that this polyphenol may be an option to potentiate the beneficial effects induced by dietary and physical activity programs in the Metabolic Syndrome (MetS) treatment.",2020,"Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol:","['25 individuals aged from 30 to 60\u202fyears old; with Body Mass Index (BMI)\u202f≥\u202f30\u202fkg/m 2 were included in the study', 'obese patients submitted to a lifestyle-changing program']","['polyphenol', 'Oral resveratrol supplementation', 'Physical activity program\u202f+\u202fDiet\u202f+\u202fResveratrol (RVS', 'Placebo: Physical activity program\u202f+\u202fDiet\u202f+\u202fPlacebo; (2) Resveratrol']","['Metabolic Syndrome features', 'total cholesterol (TC), High-density Lipoprotein cholesterol (HDL-c), Very-low density Lipoprotein cholesterol (VLDL-c), urea, creatinine and albumin serum levels', 'Anthropometric and biochemical parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",25.0,0.0319773,"Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol:","[{'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Batista-Jorge', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Barcala-Jorge', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Lelis', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'J M O', 'Initials': 'JMO', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A M B', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A L S', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'S H S', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil; Institute of Agricultural Sciences, Food Engineering College, Universidade Federal de Minas Gerais (UFMG), Montes Claros, Minas Gerais, Brazil. Electronic address: sergiosousas@hotmail.com.'}]",Life sciences,['10.1016/j.lfs.2020.117962'] 2901,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: a randomized controlled trial.,"BACKGROUND External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE). OBJECTIVE To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability. METHODS Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability. RESULTS Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed. CONCLUSIONS ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005'] 2902,32534252,"Two Weeks of Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation: A Double-Blind, Sham-Controlled, Randomized Clinical Trial.","BACKGROUND Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates. OBJECTIVE We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation. METHODS We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms. RESULTS Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2 =4.66, P=.031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P<.001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P<.013). CONCLUSIONS Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, South Carolina, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, South Carolina, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, South Carolina, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, South Carolina, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, South Carolina, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007'] 2903,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119'] 2904,32534369,Hydroxychloroquine/ chloroquine as a treatment choice or prophylaxis for Covid-19 at the primary care level in developing countries: A Primum non Nocere dilemma.,"The Food and Drug Administration (FDA) warned against the use of Hydroxychloroquine or chloroquine for Covid-19 outside of a hospital or a clinical trial setting due to the risk of QT interval prolongation, ventricular tachycardia and the increased risk of these complications when combined with some antibiotics such as azithromycin. Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients. Despite these warnings, in several developing countries the official guidelines for treatment of Covid-19 patients at the primary care level recommend Hydroxychloroquine and azithromycin, among other treatments, as the first-choice for mild symptomatic Covid-19 patients, asymptomatic contacts or for prophylaxis. In our opinion there is a primum non nocere dilemma during this Covid-19 pandemic. In order to solve this bioethical problem, we strongly recommend that a randomized controlled trial in a primary care setting be carried out as a matter of urgency in these areas of the world.",2020,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.",['COVID-19 hospitalized patients'],"['azithromycin', 'Hydroxychloroquine/ chloroquine', 'Hydroxychloroquine or chloroquine', 'Hydroxychloroquine and azithromycin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0510268,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.","[{'ForeName': 'Marco T Medina', 'Initials': 'MTM', 'LastName': 'Chevalier', 'Affiliation': 'Faculty of Medical Sciences, National Autonomous University of Honduras, WFN Regional Director for Latin America, Tegucigalpa, Honduras. Electronic address: marcotmedina@yahoo.com.'}, {'ForeName': 'Sir Salvador', 'Initials': 'SS', 'LastName': 'Moncada', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Manchester, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116972'] 2905,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D. SUBJECTS/METHODS Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction. RESULTS After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). CONCLUSIONS Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571'] 2906,32533332,"Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial.","PURPOSE The aim of the study is to compare the femoral triangle (FT) and adductor canal (AC) blocks in terms of the analgesic efficacy and ambulatory outcomes in the context of multimodal analgesia following total knee arthroplasty (TKA). METHODS Patients presenting for TKA were assigned to a preoperative ultrasound-guided single-injection FT or AC block. Combined spinal and epidural anesthesia with bupivacaine was administered for TKA. Perioperatively a multimodal analgesic regimen was applied up to 48 h after surgery. The primary outcome was the average pain score during movement in the first 24 h postoperatively. The secondary outcomes included pain scores at rest and during movement at postoperative predetermined time points, cumulative opioid consumption in oral morphine equivalents, functional mobility measured by the timed ""Up and Go"" (TUG) test and muscle strength in the lower extremity. RESULTS Ninety-eight patients completed the study. Patients in the FT group had lower median pain scores during movement in the first 24 h postoperatively than those in the AC group (1.3 [1.0-3.3] vs. 3.0 [1.7-4.3]; median difference: - 1.0, adjusted 95% CI from - 1.7 to - 0.3, P = 0.010). There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively). Cumulative oral morphine equivalent consumption in the first and second 24 h postoperatively, Functional mobility reflected by the TUG test and muscle strength in the lower extremity showed no significantly statistically differences between the two groups. CONCLUSIONS The preoperative FT block provided improved analgesic outcomes without compromising functional mobility in the context of multimodal analgesia following TKA compared with the AC block. TRIAL REGISTRATION https://www.chictr.org.cn. Identifier: ChiCTR-INR-17012716.",2020,"There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively).","['total knee arthroplasty', 'total knee arthroplasty (TKA', 'Ninety-eight patients completed the study', 'Patients presenting for TKA']","['preoperative ultrasound-guided single-injection FT or AC block', 'ultrasound-guided single-injection femoral triangle block versus adductor canal block', 'femoral triangle (FT) and adductor canal (AC) blocks', 'bupivacaine']","['pain scores', 'median pain scores', 'pain scores at rest and during movement at postoperative predetermined time points, cumulative opioid consumption in oral morphine equivalents, functional mobility measured by the timed ""Up and Go"" (TUG) test and muscle strength in the lower extremity', 'average pain score', 'Cumulative oral morphine equivalent consumption', 'TUG test and muscle strength']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0225265', 'cui_str': 'Femoral triangle structure'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",98.0,0.178078,"There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively).","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China. songlinlinlynkia@163.com.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zhi-Yu', 'Initials': 'ZY', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}]",Journal of anesthesia,['10.1007/s00540-020-02813-8'] 2907,32533354,"A comparison of nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure in critically ill patients admitted to ICU: a prospective randomized clinical trial.","BACKGROUND Although many techniques have been introduced to facilitate nasogastric tube (NGT) insertion using anatomic landmarks and a group of devices, there is a lack of general consensus regarding a standard method. The current study purposed to investigate if SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) increases the success rate of NGT correct placement versus neck flexion lateral pressure (NFLP) method. METHODS A randomized controlled trial study was conducted in two university affiliated intensive care units (tertiary referral center). Three hundred and ninety-six critically ill patients older than 18 years of age were randomly divided into SORT (n = 200) and NFLP (n = 196) groups. The technique was classified as ""failed"" after the third unsuccessful attempt. Patient characteristics, success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion were noted as main outcomes measured. RESULTS Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001). The number of failed attempts was significantly higher in the NFLP group (7.5%) vs the SORT group (3.0%) (P = 0.046). The pattern of complications was not different between two study groups (P = 0.242). The odds of stage II (odds ratio (OR) = 49.9; 95% confidence interval (CI) 25.2 to 98.6), stage III (OR = 67.1; 95% CI 14.9 to 302.8)) and stage IV (OR = 11.8; 95% CI 3.4 to 41.2) ease of insertion were much higher in NFLP compared to SORT group, after adjusting for age and body mass index (BMI). The odds of failure was not significantly different in NFLP group compared to SORT group (OR = 2.3; 95% CI 0.85 to 6.3), after adjusting for age and BMI. CONCLUSIONS SORT technique may be considered as a promising method for successful NGT insertions in critically ill patients. However, more trials are needed to confirm the results of this study. The decision must account for individual patient and clinical factors and the operator's experience and preference. TRIAL REGISTRATION The study was registered at government registry of clinical trials in Iran (http://www.IRCT.ir) (number: IRCT20091012002582N18, 13 March 2018).",2020,"RESULTS Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","['two university affiliated intensive care units (tertiary referral center', 'critically ill patients', 'critically ill patients admitted to ICU', 'Three hundred and ninety-six critically ill patients older than 18\xa0years of age']","['nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure', 'IRCT.ir', 'NFLP', 'SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement', 'NGT correct placement versus neck flexion lateral pressure (NFLP) method']","['number of failed attempts', 'pattern of complications', 'success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion', 'odds of failure']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C1301705', 'cui_str': 'Sniffing position'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",396.0,0.120383,"RESULTS Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","[{'ForeName': 'Sarvin', 'Initials': 'S', 'LastName': 'Sanaie', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Mirzalou', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samad E J', 'Initials': 'SEJ', 'LastName': 'Golzari', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Soleimanpour', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shamekh', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Bettampadi', 'Affiliation': 'Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Safiri', 'Affiliation': 'Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. amahmoodpoor@yahoo.com.'}]",Annals of intensive care,['10.1186/s13613-020-00696-2'] 2908,32533380,Effects of endotoxin adsorber hemoperfusion on sublingual microcirculation in patients with septic shock: a randomized controlled trial.,"BACKGROUND Endotoxins can induce an excessive inflammatory response and result in microcirculatory dysfunction. Polymyxin-B hemoperfusion (PMX-HP) has been recognized to effectively remove endotoxins in patients with sepsis and septic shock, and a rat sepsis model revealed that PMX-HP treatment can maintain a better microcirculation. The primary aim of this study was to investigate the effect of PMX-HP on microcirculation in patients with septic shock. METHODS Patients with septic shock were enrolled and randomized to control and PMX-HP groups. In the PMX-HP group, patients received the first session of PMX-HP in addition to conventional septic shock management within 24 h after the onset of septic shock; the second session of PMX-HP was provided after another 24 h as needed. RESULTS Overall, 28 patients finished the trial and were analyzed. The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment. At 48 h after enrollment, total vessel density (TVD) and perfused vessel density (PVD) were higher in the PMX-HP group than in the control group [TVD 24.2 (22.1-24.9) vs. 21.1 (19.9-22.9) mm/mm 2 ; p = 0.007; PVD 22.9 (20.9-24.9) vs. 20.0 (18.9-21.6) mm/mm 2 , p = 0.008]. CONCLUSIONS This preliminary study observed that PMX-HP treatment improved microcirculation but not clinical outcomes in patients with septic shock at a low risk of mortality. Nevertheless, larger multicenter trials are needed to confirm the effect of PMX-HP treatment on microcirculation in patients with septic shock at intermediate- and high-risk of mortality. Trial registration ClinicalTrials.gov protocol registration ID: NCT01756755. Date of registration: December 27, 2012. First enrollment: October 6, 2013. https://clinicaltrials.gov/ct2/show/NCT01756755.",2020,The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment.,"['Patients with septic shock', 'patients with septic shock', 'patients with sepsis and septic shock', 'patients with septic shock at intermediate- and high-risk of mortality', 'patients with septic shock at a low risk of mortality']","['control and PMX-HP', 'PMX-HP', 'endotoxin adsorber hemoperfusion', 'Polymyxin-B hemoperfusion (PMX-HP']","['total vessel density (TVD) and perfused vessel density (PVD', 'mean arterial pressure and norepinephrine infusion dose', 'sublingual microcirculation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]",,0.392238,The mean arterial pressure and norepinephrine infusion dose did not differ significantly between the control and PMX-HP groups after PMX-HP treatment.,"[{'ForeName': 'Shih-Hong', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Taipei Tzu Chi Hospital, No. 289, Jianguo Rd., New Taipei, Taiwan.'}, {'ForeName': 'Wing-Sum', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesiology, Far Eastern Memorial Hospital, No. 21, Sec. 2, Nanya S. Rd., New Taipei, Taiwan.'}, {'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Ching-Tang', 'Initials': 'CT', 'LastName': 'Chiu', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Vin-Cent', 'Initials': 'VC', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Wang-Huei', 'Initials': 'WH', 'LastName': 'Sheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Department of Surgery, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Ming-Jiuh', 'Initials': 'MJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chang', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Department of Anesthesiology, National Taiwan University Hospital, No 7, Chung Shang South Road, Taipei, Taiwan. tonyyeh@ntuh.gov.tw.'}]",Annals of intensive care,['10.1186/s13613-020-00699-z'] 2909,32533622,Blood pressure after follow-up in a stroke prevention clinic.,"OBJECTIVES In Denmark, 25% of hospital admissions with stroke are recurrent strokes. With thrombolytic treatment, more patients survive with only minor disability. This promising development should be followed up by intensive secondary prevention. Hypertension is the most important target. We aimed at testing the hypotheses that early follow-up in a preventive clinic would result in (a) a higher proportion of patients with blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death would be longer in the intervention group compared to controls. MATERIALS AND METHODS Eligible patients admitted to the stroke unit of Herlev Hospital were randomized shortly before discharge to intervention or control group. Of 78 included participants, data from 73 were available for follow-up 9 months after inclusion. Patients in the intervention group were seen in the clinic within 1 week. In case of hypertension, treatment was initiated or supplied with a new drug. We used individual targets for blood pressure according to diagnosis of stroke and patients' comorbidity. Patients in the intervention group had a median of five visits to the preventive clinic. RESULTS In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007). Median time to first event was 44 months (4-49) in the intervention group and 19 months (4-37) in controls (p = .316). CONCLUSIONS Treatment of hypertension to individual targets after stroke is feasible. It may postpone recurrent stroke and death in stroke survivors.",2020,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","['Of 78 included participants, data from 73 were available for follow-up 9\xa0months after inclusion', 'In Denmark, 25% of hospital admissions with stroke are recurrent strokes', 'Eligible patients admitted to the stroke unit of Herlev Hospital']",[],"['blood pressure', 'median of five visits to the preventive clinic', 'Median time to first event', 'blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death', 'Blood pressure']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",78.0,0.0464616,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","[{'ForeName': 'Agnete Hviid', 'Initials': 'AH', 'LastName': 'Hornnes', 'Affiliation': 'Department of Neurology, Herlev og Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Mai Bang', 'Initials': 'MB', 'LastName': 'Poulsen', 'Affiliation': 'Department of Neurology, Rigshospitalet, Copenhagen, Denmark.'}]",Brain and behavior,['10.1002/brb3.1667'] 2910,32533644,Effects of oxiracetam combined with ginkgo biloba extract in the treatment of acute intracerebral hemorrhage: A clinical study.,"PURPOSE The present clinical study was conducted to investigate the effect of oxiracetam combined with ginkgo biloba extract in treating patients with acute intracerebral hemorrhage. METHODS Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital were divided into three groups. The differences of brain edema and cerebral hemorrhage were compared between the three groups after 1 and 2 weeks of treatment, and the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions were compared between the three groups after 2 weeks of treatment. RESULTS There was no significant difference among the three groups before treatment (p > .05). After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved. Among them, the neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living in the combined treatment group and the control group elicited greater results than those in the routine group. The results of the combined treatment group showed the most significant difference (p < .05). The concentration of IL-6 decreased from 135.98 ± 12.54 to 91.83 ± 7.69 pg/ml, AQP-4 from 227.55 μg/L ± 21.06 to 114.31 ± 9.22 μg/L, and MMP-9 from 172.39 ± 9.81 to 94.98 ± 5.01 ng/ml. In addition, the neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living in the combined treatment group were better than those in the control group (p < .05). The mean score of MRS in the combined treatment group decreased from 3.36 ± 0.98 at admission to 1.91 ± 0.38. CONCLUSION Oxiracetam combined with Ginkgo biloba extract in the treatment of acute cerebral hemorrhage has a significant improvement effect.",2020,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","['acute intracerebral hemorrhage', 'patients with acute intracerebral hemorrhage', 'Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital']","['Ginkgo biloba extract', 'oxiracetam combined with ginkgo biloba extract']","['neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living', 'acute cerebral hemorrhage', 'brain edema and cerebral hemorrhage', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'concentration of IL-6', 'mean score of MRS', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0069772', 'cui_str': 'oxiracetam'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",98.0,0.0301242,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","[{'ForeName': 'Xiu-Xiu', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Hui', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Su-Jing', 'Initials': 'SJ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Feng', 'Initials': 'SF', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shou-Liang', 'Initials': 'SL', 'LastName': 'Pang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1661'] 2911,32533723,Preoperative high-dose Steroids in Total Knee and Hip Arthroplasty - Protocols for three randomized controlled trials.,"BACKGROUND Patients undergoing total knee arthroplasty (TKA) / total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes. Patients already on opioid-treatment, and pain catastrophizers (PCs) have a higher risk of postoperative pain. The use of preoperative intravenous high-dose glucocorticoids decreases postoperative pain after TKA and THA, but optimal dose is yet to be found, and the effect on subpopulations at high pain risk is unknown. AIM To investigate the effect of a higher than previously used dose of glucocorticoids (dexamethasone (DXM)), administered intravenously before surgery, as part of standardized fast-track regimen, on postoperative pain in TKA/THA subgroups. METHOD Three separate randomized, double-blinded, controlled trials are planned to compare a new higher dose DXM (1 mg/kg) to the earlier used high-dose DXM (0.3 mg/kg). Study 1: predicted Low Pain TKA; study 2: predicted High Pain Responder (HPR) TKA; study 3: predicted HPR THA. Predicted HPR groups consist of either PCs with PCS-score of ≥21 and/or history of ongoing opioid-treatment of 30 mg/day of morphine or equivalents >30 days. 408 patients in total are planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA). PRIMARY OUTCOME Pain upon ambulation in a 5-meter walk test 24 hours after surgery. Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality. Patients are completed for follow-up on day 90. Recruiting commenced February 2019 and is expected to finish September 2020.",2020,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","['408 patients in total are planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA', 'Total Knee and Hip Arthroplasty - Protocols', 'Patients undergoing total knee arthroplasty (TKA) / total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes']","['glucocorticoids (dexamethasone (DXM', 'glucocorticoids', 'DXM', 'Preoperative high-dose Steroids', 'morphine']","['Pain upon ambulation in a 5-meter walk test 24 hours after surgery', 'use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality']","[{'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.22163,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","[{'ForeName': 'Niklas I', 'Initials': 'NI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, 7621, Rigshospitalet, University of Copenhagen, Blegdamsvej 9 DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Varnum', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kjaersgaard-Andersen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Lasse E', 'Initials': 'LE', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mandøe', 'Affiliation': 'Department of Anaesthesiology, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Nicolai B', 'Initials': 'NB', 'LastName': 'Foss', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13656'] 2912,32533742,An psychoeducation program based on self-efficacy theory to improve experience of natural birth for primigravid women : Study protocol for a randomized controlled trial.,"AIM To present a study protocol for estimating the feasibility, effectiveness and safety of an Individual (5 sessions), group(1 session) and face-to-face psychoeducation program based on self-efficacy theory to improve childbirth experience of primigravid women. BACKGROUND In present China, fertility rates are falling and aging is accelerating. How to improve the fertility level of childbearing women is of great significance. However, about 10-20% of women have negative childbirth experience after birth, which seriously affects maternal and child health and family functions, and even fertility desires and intentions in the future. Nevertheless, due to the lack of a series of well-designed randomized controlled trials, there is no specific methodology to guide the most effective intervention for primigravid women. In this regard, based on Bandura's self-efficacy theory, an intervention program to promote a positive childbirth experience for primigravid women has been designed and will be evaluated to determine its impact on primigravid women. DESIGN A non-blinded randomized controlled trial. METHODS We report the study protocol for this randomized controlled trial based on the SPIRIT2013 statement. A total of 238 eligible primigravid women will be randomly divided into the control group(n=119) or the intervention group(n=119). The control group will receive care as usual, that is, six routine prenatal examinations. In addition to the routine examinations, the intervention group will also receive six face-to-face interventions. Baseline assessment will occur at about 24th week of gestation and follow up at 37th weeks of gestation, intrapartum, 1-3 days postpartum, and 42 days postpartum. The primary outcomes are childbirth experience, childbirth self-efficacy; others are fear of childbirth, labor control, labor pain and labor satisfaction. IMPACT From the perspective of clinical work, this protocol provides practical guidance for cultivating the positive childbirth experience of the primigravid women. From the perspective of sociology, the positive experience and emotion of primigravid women can improve the fertility intention of women of childbearing age, which is relatively conducive to optimizing Chinese demographic structure and reducing the pressure of aging population in the long term.",2020,A total of 238 eligible primigravid women will be randomly divided into the control group(n=119) or the intervention group(n=119).,"['primigravid women', 'primigravid women ', 'childbirth experience of primigravid women', 'childbearing women', '238 eligible primigravid women']","['Individual (5 sessions), group(1 session) and face-to-face psychoeducation program']","['fertility level', 'feasibility, effectiveness and safety', 'childbirth experience, childbirth self-efficacy; others are fear of childbirth, labor control, labor pain and labor satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",238.0,0.0989844,A total of 238 eligible primigravid women will be randomly divided into the control group(n=119) or the intervention group(n=119).,"[{'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yanggao', 'Initials': 'Y', 'LastName': 'Bu', 'Affiliation': 'Department of Obstetrics and Gynecology, 901 Hospital of the Joint Logistics Support Force of PLA, Hefei, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, 901 Hospital of the Joint Logistics Support Force of PLA, Hefei, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}]",Journal of clinical nursing,['10.1111/jocn.15370'] 2913,32533763,Effectiveness of manual lymphatic drainage vs. perineal massage in secundigravida women with gestational oedema: A randomised clinical trial.,"Perineal trauma (PT) may be considered as a very common injury during the childbirth. The incidence of PT was estimated in 30% to 85%, with 60% to 70% requiring suture. The present study was a prospective, single-blinded, randomised, clinical trial carried out from January 2015 to January 2016. For this study, 49 secundigravida women diagnosed with gestational oedema were recruited and randomly divided into two groups (A and B). Group A (n = 30) received the conventional treatment plus perineal massage and group B (n = 19) the conventional treatment plus manual lymphatic drainage (MLD). Visual analogue scale (VAS) and King Health´s Questionnaire (KHQ) were performed to assess pain intensity and quality of life-related with urinary incontinence (UI). Pain intensity measurements showed statistically significant differences for a decrease after 30-weeks (P = .037), after 36-weeks (P = .000), and at the end of puerperium (P = .014) for MLD with respect to perineal massage group. Moreover, inter-groups repeated measures ANOVA for the values related statistically significant differences to the interaction of each applied treatment (perineal massage and MLD group, separately) over the pain intensity variable. MLD treatment reduced pain intensity with respect to perineal massage in secundigravida women with gestational oedema from 25-weeks of gestation to the end of puerperium.",2020,MLD treatment reduced pain intensity with respect to perineal massage in secundigravida women with gestational oedema from 25-weeks of gestation to the end of puerperium.,"['January 2015 to January 2016', 'secundigravida women with gestational oedema', '49 secundigravida women diagnosed with gestational oedema']","['conventional treatment plus perineal massage', 'conventional treatment plus manual lymphatic drainage (MLD', 'MLD', 'manual lymphatic drainage vs. perineal massage']","['Perineal trauma (PT', 'incidence of PT', 'pain intensity', 'pain intensity and quality of life-related with urinary incontinence (UI', 'Visual analogue scale (VAS) and King Health´s Questionnaire (KHQ', 'Pain intensity measurements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341960', 'cui_str': 'Gestational edema'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",49.0,0.073139,MLD treatment reduced pain intensity with respect to perineal massage in secundigravida women with gestational oedema from 25-weeks of gestation to the end of puerperium.,"[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'de la Cueva-Reguera', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Facultad de Enfermería, Físioterapia y Podologia, Universidad Complutense de Madrid, Madrid, 28040, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Facultad de Enfermería, Físioterapia y Podologia, Universidad Complutense de Madrid, Madrid, 28040, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Fernández-Martínez', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Martínez-Pascual', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Robledo-Do-Nascimento', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Blanco-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, 28670, Spain.'}]",International wound journal,['10.1111/iwj.13427'] 2914,32533785,"Apatinib plus Chemotherapy as a Second-Line Treatment in Unresectable Non-Small Cell Lung Carcinoma: A Randomized, Controlled, Multicenter Clinical Trial.","LESSONS LEARNED The efficacy of second-line treatment for advanced non-small cell lung carcinoma (NSCLC) without a sensitizing driver gene mutation is still unsatisfactory. The combination of apatinib and chemotherapy improved progression-free survival in the second-line therapy of advanced NSCLC without a sensitizing mutation. This study offers a new treatment strategy for second-line treatment of such patients but requires confirmation in a larger multi-institutional trial. BACKGROUND This study explored the efficacy and safety of apatinib combined with single-agent chemotherapy versus single-agent chemotherapy in the second-line treatment of advanced non-small-cell lung carcinoma (NSCLC) without driver mutations. METHODS In this double-arm, open label, exploratory clinical study, we enrolled patients with unresectable locally advanced or advanced NSCLC without driver mutations that had progressed following first-line chemotherapy. The subjects were allocated into an experimental group and a control group by 2:1. The experimental group received apatinib combined with four cycles of docetaxel or pemetrexed until disease progression, intolerable toxicity, or discontinuation at the patient's request. The control group only received four cycles of docetaxel or pemetrexed. The primary endpoints were progression-free survival (PFS), and the secondary endpoints were overall survival (OS), disease control rate (DCR), and safety. RESULTS Thirty-seven patients were enrolled. The efficacy of 33 patients was evaluated. The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group. The OS was still under follow-up. The most common adverse effects included hypertension, hand-foot skin reaction (HFSR), and fatigue. CONCLUSION Apatinib combined with single-agent chemotherapy may be a novel option for second-line treatment of advanced NSCLC.",2020,"The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group.","['advanced non-small-cell lung carcinoma (NSCLC) without driver mutations', '33 patients', 'advanced non-small cell lung carcinoma (NSCLC', 'Unresectable Non-Small Cell Lung Carcinoma', 'enrolled patients with unresectable locally advanced or advanced NSCLC without driver mutations that had progressed following first-line chemotherapy', 'Thirty-seven patients were enrolled']","['docetaxel or pemetrexed', 'apatinib combined with single-agent chemotherapy versus single-agent chemotherapy', 'apatinib combined with four cycles of docetaxel or pemetrexed', 'second-line treatment', 'Apatinib plus Chemotherapy', 'apatinib and chemotherapy', 'Apatinib combined with single-agent chemotherapy']","['objective response rate (ORR', 'progression-free survival', 'efficacy and safety', 'overall survival (OS), disease control rate (DCR), and safety', 'hypertension, hand-foot skin reaction (HFSR), and fatigue', 'progression-free survival (PFS', 'DCR', 'median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",37.0,0.11037,"The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group.","[{'ForeName': 'Zongyang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Jinhuo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Affiliated Union Hospital of Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Wencui', 'Initials': 'W', 'LastName': 'Kong', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""First Affiliated Hospital of Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'Zhongquan', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Xiangwu', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People's Republic of China.""}, {'ForeName': 'Wujin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Fujian People's Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Zhengbo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': ""Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2020-0519'] 2915,32533791,The effect of dexmedetomidine on postoperative behaviour change in children: a randomised controlled trial.,"Children may develop changes in their behaviour following general anaesthesia. Some examples of negative behaviour include temper tantrums and nightmares, as well as sleep and eating disorders. The aim of this study was to determine whether dexmedetomidine reduces the incidence of negative behaviour change after anaesthesia for day case surgery in children aged two to seven years. Children were randomly allocated to one of three groups: a premedication group received 2 mg.kg -1 intranasal dexmedetomidine; an intra-operative group received 1 mg.kg -1 intravenous dexmedetomidine; and a control group. The primary outcome was the incidence of negative behaviour on postoperative day 3 using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strength and Difficulties Questionnaire (SDQ). Secondary outcomes included: the incidence of negative behaviour on postoperative days 14 and 28; anxiety at induction; emergence delirium; pain; length of recovery and hospital stay; and any adverse events. The data for 247 patients were analysed. Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99). The incidence of negative behaviour in the group who received dexmedetomidine intra-operatively was less at postoperative day 28 (15% compared with 36% in the dexmedetomidine premedication group and 41% in the control group, p<0.001). We conclude that dexmedetomidine does not reduce the incidence of negative behaviour on postoperative day 3 in two to seven-year olds having day case procedures.",2020,"Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99).","['children aged two to seven years', '247 patients were analysed', 'children']","['dexmedetomidine', 'premedication group received 2 mg.kg -1 intranasal dexmedetomidine']","['incidence of negative behaviour on postoperative days 14 and 28; anxiety at induction; emergence delirium; pain; length of recovery and hospital stay; and any adverse events', 'SDQ', 'Negative behaviour change on postoperative day 3', 'negative behaviour change', 'PHBQ-AS', 'incidence of negative behaviour on postoperative day 3 using the Post-Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strength and Difficulties Questionnaire (SDQ', 'incidence of negative behaviour', 'postoperative behaviour change']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",247.0,0.128924,"Negative behaviour change on postoperative day 3 was similar between all three groups when measured with the PHBQ-AS (47%, 44% and 51% respectively; adjusted p=0.99) and the SDQ (median scores 7.5, 6.0 and 8.0 respectively; adjusted p=0.99).","[{'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Lee-Archer', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'von Ungern-Sternberg', 'Affiliation': ""Department of Anaesthesia and Pain Management, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reade', 'Affiliation': 'Royal Brisbane Clinical Unit, Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Betts', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haenke', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Keys', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rance', 'Affiliation': ""Department of Anaesthesia, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gibbons', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Paediatric Critical Care Research Group, Child Health Research Centre, Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.'}]",Anaesthesia,['10.1111/anae.15117'] 2916,32533792,"Perioperative COX2 and β-adrenergic blockade improves biomarkers of tumor metastasis, immunity, and inflammation in colorectal cancer: A randomized controlled trial.","BACKGROUND Preclinical studies have implicated excess release of catecholamines and prostaglandins in the mediation of prometastatic processes during surgical treatment of cancer. In this study, we tested the combined perioperative blockade of these pathways in patients with colorectal cancer (CRC). METHODS In a randomized, double-blind, placebo-controlled biomarker trial involving 34 patients, the β-blocker propranolol and the COX2-inhibitor etodolac were administered for 20 perioperative days, starting 5 days before surgery. Excised tumors were subjected to whole genome messenger RNA profiling and transcriptional control pathway analyses. RESULTS Drugs were well-tolerated, with minor complications in both the treatment group and the placebo group. Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 + monocytes and CD19 + B cells, and 3) increased tumor infiltrating CD56 + natural killer cells. Transcriptional activity analyses indicated a favorable drug impact on 12 of 19 a priori hypothesized CRC-related transcription factors, including the GATA, STAT, and EGR families as well as the CREB family that mediates the gene regulatory impact of β-adrenergic- and prostaglandin-signaling. Alterations observed in these transcriptional activities were previously associated with improved long-term clinical outcomes. Three-year recurrence rates were assessed for long-term safety analyses. An intent-to-treat analysis revealed that recurrence rates were 12.5% (2/16) in the treatment group and 33.3% (6/18) in the placebo group (P = .239), and in protocol-compliant patients, recurrence rates were 0% (0/11) in the treatment group and 29.4% (5/17) in the placebo group (P = .054). CONCLUSIONS The favorable biomarker impacts and clinical outcomes provide a rationale for future randomized placebo-controlled trials in larger samples to assess the effects of perioperative propranolol/etodolac treatment on oncological clinical outcomes.",2020,"Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 + monocytes and CD19 + B cells, and 3) increased tumor infiltrating CD56 + natural killer cells.","['colorectal cancer', '34 patients, the', 'patients with colorectal cancer (CRC']","['β-blocker propranolol and the COX2-inhibitor etodolac', 'Perioperative COX2 and\xa0β-adrenergic blockade', 'propranolol/etodolac treatment', 'placebo']","['recurrence rates', 'tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 + monocytes and CD19 + B cells, and 3) increased tumor infiltrating CD56 + natural killer cells', 'tolerated']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0059865', 'cui_str': 'Etodolac'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0108754', 'cui_str': 'Lymphocyte antigen CD56'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}]",34.0,0.578287,"Treatment resulted in a significant improvement (P < .05) of tumor molecular markers of malignant and metastatic potential, including 1) reduced epithelial-to-mesenchymal transition, 2) reduced tumor infiltrating CD14 + monocytes and CD19 + B cells, and 3) increased tumor infiltrating CD56 + natural killer cells.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haldar', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Ricon-Becker', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Radin', 'Affiliation': 'Department of Psychology, UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Gutman', 'Affiliation': 'Department of Surgery and Transplantation, Sheba Medical Center, Ramat-Gan, Israel.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Departments of Medicine and Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Zmora', 'Affiliation': ""Department of Surgery, Shamir Medical Center, Be'er-Ya'akov, Israel.""}, {'ForeName': 'Shamgar', 'Initials': 'S', 'LastName': 'Ben-Eliyahu', 'Affiliation': 'Sagol School of Neuroscience and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel.'}]",Cancer,['10.1002/cncr.32950'] 2917,30145365,Dietary and Plasma Polyunsaturated Fatty Acids Are Inversely Associated with Asthma and Atopy in Early Childhood.,"BACKGROUND Polyunsaturated fatty acids (PUFAs) influence immune function and risk of allergic disease. Prior evidence of the effect of PUFA intake on childhood asthma and allergy is inconclusive. OBJECTIVES To investigate associations of PUFA plasma levels and dietary intake with asthma and allergy at age 3 years in this ancillary study of the Vitamin D Antenatal Asthma Reduction Trial. METHODS Plasma PUFA levels were reported as relative abundances from mass spectrometry profiling, and dietary PUFA intake was derived from food frequency questionnaire responses. Associations between PUFA and outcomes, including asthma and/or recurrent wheeze, allergic sensitization, and total IgE at age 3 years, were evaluated in adjusted regression models. Additional regression models analyzed the combined effects of antenatal vitamin D and early childhood PUFA on outcomes. RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization. Likewise, dietary PUFA intake was inversely associated with asthma and/or recurrent wheeze (P < .05 for omega-6 PUFA only). For both dietary and plasma measures of total, omega-3, and omega-6 PUFAs, inverse associations with outcomes were strongest among subjects with both high umbilical cord blood 25-hydroxyvitamin D and high PUFA at age 3 years. CONCLUSIONS PUFA dietary intake and plasma levels are inversely associated with asthma and/or recurrent wheeze and atopy at age 3 years. Antenatal vitamin D could modulate the effect of early childhood PUFA on risk of asthma and allergy.",2019,"RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization.",['subjects with both high umbilical cord blood 25-hydroxyvitamin D and high PUFA at age 3 years'],"['Antenatal vitamin D', 'antenatal vitamin D and early childhood PUFA', 'Polyunsaturated fatty acids (PUFAs', 'PUFA intake']","['asthma and/or recurrent wheeze, allergic sensitization, and total IgE', 'Likewise, dietary PUFA intake', 'asthma and/or recurrent wheeze and allergic sensitization', 'Total, omega-3, and omega-6 plasma PUFA relative abundances', 'asthma and/or recurrent wheeze']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C3662483', 'cui_str': 'Allergic sensitization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0332669,"RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Lee-Sarwar', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. Electronic address: klee-sarwar@partners.org.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kelly', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Kachroo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Departments of Allergy and Research and Evaluation, Kaiser Permanente Southern California, San Diego and Pasadena, Calif.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center and Department of Medicine, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Megan T', 'Initials': 'MT', 'LastName': 'Sandel', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Mass.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Mass.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, New York, NY. Electronic address: augusto_litonjua@urmc.rochester.edu.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.07.039'] 2918,30388029,Changes in Sleep Problems Across Attention-Deficit/Hyperactivity Disorder Treatment: Findings from the Multimodal Treatment of Attention-Deficit/Hyperactivity Disorder Study.,"Objective: Stimulant medication and behavior therapy are efficacious for youth with attention-deficit/hyperactivity disorder (ADHD). However, research suggests that stimulants may start and/or worsen sleep problems for youth. Further, the impact of behavior therapy for ADHD on sleep is unknown. This study examined the frequency of sleep problems and effects of stimulant medication, behavior therapy, and their combination on sleep problems in youth with ADHD. This study also explored the influence of dimensional baseline ratings of ADHD symptom subtype and psychiatric comorbidity on sleep outcomes. Methods: Participants were 576 children (aged 7-9 years) with ADHD-Combined type from the Multimodal Treatment of ADHD study that compared methylphenidate, behavior therapy, and their combination to community care. Before treatment, parents completed the Child Behavior Checklist used to derive a total sleep problems score. Parents also completed ratings of oppositionality and ADHD symptom severity, whereas youth completed ratings of depression and anxiety. These ratings were readministered after treatment. Results: General linear mixed-effects models were used to assess change in total sleep problems across treatment. The combined group exhibited a statistically significant reduction in total sleep problems ( z  = -5.81, p  < 0.001). Reductions in total sleep problems in methylphenidate (z = -3.11, p  = 0.05), behavior therapy ( z  = -2.99, p  = 0.08), or community care ( z  = -1.59, p  > 0.99) did not reach statistical significance. Change in psychiatric symptoms did not significantly moderate change in total sleep problems by treatment assignment. Greater baseline oppositional defiant disorder severity predicted less reduction in total sleep problems, χ 2 (1) = 3.86, p  < 0.05. Conclusions: Findings suggest that combination of methylphenidate and behavior therapy is efficacious for reducing parent-reported sleep problems in young children with ADHD-Combined type relative to community care. However, potential ameliorative effects of monotherapy treatments (i.e., methylphenidate, behavior therapy) should be examined. Future replication is needed to confirm findings.",2018,"Reductions in total sleep problems in methylphenidate (z = -3.11, p  = 0.05), behavior therapy ( z  = -2.99, p  = 0.08), or community care ( z  = -1.59, p  > 0.99) did not reach statistical significance.","['youth with ADHD', 'young children with ADHD-Combined type relative to community care', 'Participants were 576 children (aged 7-9 years) with ADHD-Combined type from the Multimodal Treatment of ADHD study that compared', 'youth with attention-deficit/hyperactivity disorder (ADHD']","['methylphenidate, behavior therapy, and their combination to community care', 'Stimulant medication and behavior therapy', 'methylphenidate', 'methylphenidate and behavior therapy', 'stimulant medication, behavior therapy, and their combination']","['behavior therapy', 'total sleep problems score', 'ratings of oppositionality and ADHD symptom severity', 'total sleep problems']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",576.0,0.0514823,"Reductions in total sleep problems in methylphenidate (z = -3.11, p  = 0.05), behavior therapy ( z  = -2.99, p  = 0.08), or community care ( z  = -1.59, p  > 0.99) did not reach statistical significance.","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Ricketts', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sturm', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'McMakin', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Patricia Z', 'Initials': 'PZ', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Fallon B', 'Initials': 'FB', 'LastName': 'Smalberg', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Colwell', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0038'] 2919,30674707,Integrated adventure-based training and health education programme in promoting regular physical activity among childhood cancer survivors.,,2019,,['childhood cancer survivors'],['Integrated adventure-based training and health education programme'],[],"[{'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]",[],,0.0138449,,"[{'ForeName': 'W H C', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'G C F', 'Initials': 'GCF', 'LastName': 'Chan', 'Affiliation': 'Department of Adolescent Medicine, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'M H S', 'Initials': 'MHS', 'LastName': 'Lam', 'Affiliation': 'School for Higher and Professional Education, Vocational Training Council, Hong Kong.'}, {'ForeName': 'J O K', 'Initials': 'JOK', 'LastName': 'Chung', 'Affiliation': 'School of Nursing, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Chiu', 'Affiliation': 'Department of Adolescent Medicine, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'D Y T', 'Initials': 'DYT', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, Queen Mary Hospital, Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 2920,30865288,"The association between mixed symptoms, irritability and functioning measured using smartphones in bipolar disorder.","OBJECTIVE To (i) validate patient-evaluated mixed symptoms and irritability measured using smartphones against clinical evaluations; (ii) investigate associations between mixed symptoms and irritability with stress, quality of life and functioning, respectively, in patients with bipolar disorder. METHODS A total of 84 patients with bipolar disorder used a smartphone-based system for daily evaluation of mixed symptoms and irritability for nine months. Clinically evaluated symptoms, stress, quality of life and clinically rated functioning were collected multiple times during follow-up. RESULTS Patients presented mild affective symptoms. Patient-reported mixed symptoms and irritability correlated with clinical evaluations. In analyses including confounding factors there was a statistically significant association between both mixed symptoms and irritability and stress (P < 0.0001) and between irritability and both quality of life and functioning (P < 0.0001) respectively. There was no association between mixed mood and both quality of life and functioning. CONCLUSION Mixed symptoms and irritability can be validly self-reported using smartphones in patients with bipolar disorder. Mixed symptoms and irritability are associated with increased stress even during full or partial remission. Irritability is associated with decreased quality of life and functioning. The findings emphasize the clinical importance of identifying inter-episodic symptoms including irritability pointing towards smartphones as a valid tool.",2019,In analyses including confounding factors there was a statistically significant association between both mixed symptoms and irritability and stress (P < 0.0001) and between irritability and both quality of life and functioning (P ,"['patients with bipolar disorder', '84 patients with bipolar disorder used a smartphone-based system for daily evaluation of mixed symptoms and irritability for nine months']",[],"['mixed symptoms and irritability and stress', 'symptoms, stress, quality of life and clinically rated functioning', 'quality of life and functioning', 'mild affective symptoms', 'irritability and both quality of life and functioning (P', 'Irritability', 'irritability with stress, quality of life and functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}]",84.0,0.0657153,In analyses including confounding factors there was a statistically significant association between both mixed symptoms and irritability and stress (P < 0.0001) and between irritability and both quality of life and functioning (P ,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Monsenso ApS, Valby, Denmark.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Department of Applied Mathematics and Computer Science, The Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'L V', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13021'] 2921,32530717,The impact of a yoga-based physical therapy group for individuals with traumatic brain injury: results from a pilot study.,"OBJECTIVE To compare the impacts of yoga-based physical therapy versus a seated rest within the context of standard rehabilitation practice on sleep, heart rate variability (HRV), anxiety, and fatigue during acute traumatic brain injury (TBI) rehabilitation. METHODS Eleven individuals participated in this crossover study involving the following interventions in a randomized order: group yoga-based physical therapy (YPT), conventional physical therapy (CPT), and group seated rest in a relaxing environment (SR). HRV and self-reported anxiety and fatigue were measured immediately before and after each group, and sleep after each condition and at baseline. Data was analyzed using generalized linear mixed models with repeated measures. RESULTS The interaction between time and treatment was statistically significant ( p = .0203). For the SR treatment, wake after sleep onset (WASO) rate was reduced from 14.99 to 10.60 (IRR = 0.71; p = .006). Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes. CONCLUSION Yoga-based physical therapy is feasible and safe in the inpatient rehabilitation setting following TBI. Sleep quality improved following the addition of a one-hour seated rest in a relaxing environment to a standard rehabilitation daily schedule, suggesting that structured rest time may be beneficial to sleep hygiene during inpatient rehabilitation following TBI. ClinicalTrials.Gov Registration Number: NCT03701594.",2020,"Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes. ","['Eleven individuals participated', 'individuals with traumatic brain injury']","['Yoga-based physical therapy', 'yoga-based physical therapy (YPT), conventional physical therapy (CPT), and group seated rest in a relaxing environment (SR', 'yoga-based physical therapy']","['sleep, heart rate variability (HRV), anxiety, and fatigue', 'sleep onset (WASO) rate', 'Sleep quality', 'HRV and self-reported anxiety and fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",11.0,0.0600584,"Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes. ","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Krese', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ingraham', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': ""O'Brien"", 'Affiliation': 'Max Näder Center for Rehabilitation Technologies and Outcomes Research, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Chaithanya K', 'Initials': 'CK', 'LastName': 'Mummidisetty', 'Affiliation': 'Max Näder Center for Rehabilitation Technologies and Outcomes Research, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McNulty', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Srdanovic', 'Affiliation': 'Biostatistics Collaboration Center, Northwestern University Feinberg School of Medicine , Chicago, Illinois, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Biostatistics Collaboration Center, Northwestern University Feinberg School of Medicine , Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ripley', 'Affiliation': 'Brain Innovation Center, Shirley Ryan AbilityLab , Chicago, Illinois, USA.'}]",Brain injury,['10.1080/02699052.2020.1776394'] 2922,32530760,Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts.,"PURPOSE Three new therapies have been approved recently for the adjuvant treatment of stage III melanoma, substantially reducing the risk of tumor recurrences. This study evaluates 3 independent data sets to clarify the survival probabilities of patients with stage III melanoma. PATIENTS AND METHODS The Central Malignant Melanoma Registry (CMMR) evaluated 1,553 patients with a primary diagnosis of stage III melanoma from 2000 to 2012. Studies from the European Organisation for Research and Treatment of Cancer (EORTC), of 573 patients in the observation arm of the 18991 study and 445 patients in the placebo arm of the 18071 study, were evaluated as reference cohorts. The survival outcomes were compared with the published American Joint Committee on Cancer version 8 (AJCCv8) stage III survival data. RESULTS For the CMMR stage III cohort versus the AJCCv8 cohort, the melanoma-specific survival (MSS) rates at 5 years were 67% versus 77%, and at 10 years were 56% versus 69%, respectively. For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%. The MSS rates of the EORTC studies either overlapped with or were lower than, the CMMR data. CONCLUSION The MSS rates in the CMMR and EORTC cohorts over the entire stage III are less favorable than those published in AJCCv8. This is particularly true for substages IIIA and IIIB.",2020,"For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%.","['573 patients in the observation arm of the 18991 study and 445 patients in the placebo arm of the 18071 study, were evaluated as reference cohorts', 'Patients With Stage III Melanoma', 'patients with stage III melanoma', 'The Central Malignant Melanoma Registry (CMMR) evaluated 1,553 patients with a primary diagnosis of stage III melanoma from 2000 to 2012']",[],"['MSS rates', 'survival probabilities', 'melanoma-specific survival (MSS) rates', 'survival outcomes', 'Cancer version 8 (AJCCv8) stage III survival data']","[{'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]",1553.0,0.101388,"For stage IIIA, the MSS rates at 5 years were 80% versus 93%, and at 10 years were 71% versus 88%; for stage IIIB, the MSS rates at 5 years were 75% versus 83%, and at 10 years were 61% versus 77%.","[{'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Keim', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Amaral', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Eigentler', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gesierich', 'Affiliation': 'Department of Dermatology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Heinzerling', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Kiecker', 'Affiliation': 'Skin Cancer Center, Department of Dermatology, Charité Berlin, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, & German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Department of Dermatology, Johannes Wesling Hospital Minden, Ruhr-University of Bochum, Minden, Germany.'}, {'ForeName': 'Cord', 'Initials': 'C', 'LastName': 'Sunderkötter', 'Affiliation': 'Department of Dermatology and Venereology, University Hospital Halle, Halle, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tüting', 'Affiliation': 'Department of Dermatology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Utikal', 'Affiliation': 'Skin Cancer Unit, German Cancer Research Center (DKFZ), Heidelberg, Germany and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wollina', 'Affiliation': 'Department of Dermatology and Allergology, Municipal Hospital of Dresden, Dresden, Germany.'}, {'ForeName': 'Christos C', 'Initials': 'CC', 'LastName': 'Zouboulis', 'Affiliation': 'Departments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Testori', 'Affiliation': 'Department of Dermatology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute of Clinical Epidemiology and Applied Biostatistics, Eberhard-Karls-University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Leiter', 'Affiliation': 'Center for Dermatooncology, Department of Dermatology, Eberhard Karls University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03034'] 2923,32530765,Prospective Evaluation of Radiation Dose Escalation in Patients With High-Risk Neuroblastoma and Gross Residual Disease After Surgery: A Report From the Children's Oncology Group ANBL0532 Study.,"PURPOSE A primary objective of the Children's Oncology Group (COG) ANBL0532 phase III study was to assess the effect of increasing local dose of radiation to a residual primary tumor on the cumulative incidence of local progression (CILP) in patients with high-risk neuroblastoma. PATIENTS AND METHODS Newly diagnosed patients with high-risk neuroblastoma were randomly assigned or assigned to receive single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy. Local control consisted of surgical resection during induction chemotherapy and radiotherapy after last SCT. Patients received 21.6 Gy to the preoperative primary tumor volume. For patients with incomplete surgical resection, an additional boost of 14.4 Gy was delivered to the gross residual tumor, for a total dose of 36 Gy. CILP (primary end point) and event-free (EFS) and overall survival (OS; secondary end points) were compared with the COG A3973 historical cohort, in which all patients received single SCT and 21.6 Gy without a boost. RESULTS For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P = .0590), 47.0% ± 3.5% ( P = .0090), and 57.4% ± 3.5% ( P = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively. Five-year CILP, EFS, and OS rates for patients in A3973 with incomplete resection and radiotherapy (n = 47) were 10.6% ± 4.6%, 48.9% ± 10.1%, and 56.9% ± 10.0%, respectively. In comparison, 5-year CILP, EFS, and OS rates for patients in ANBL0532 who were randomly assigned or assigned to single SCT and received boost radiotherapy (n = 74) were 16.3% ± 4.3% ( P = .4126), 50.9% ± 7.0% ( P = .5084), and 68.1% ± 6.7% ( P = .2835), respectively. CONCLUSION Boost radiotherapy to gross residual tumor present at the end of induction did not significantly improve 5-year CILP. These results highlight the need for new strategies to decrease the risk of locoregional failure.",2020,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P = .0590), 47.0% ± 3.5% ( P = .0090), and 57.4% ± 3.5% ( P = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","['Patients With High-Risk Neuroblastoma and Gross Residual Disease', 'Newly diagnosed patients with high-risk neuroblastoma', 'patients with high-risk neuroblastoma']","['radiotherapy', 'ANBL0532 receiving radiotherapy', 'surgical resection during induction chemotherapy and radiotherapy', 'boost radiotherapy', 'Radiation Dose Escalation', 'single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy', 'Boost radiotherapy']","['EFS, and OS rates', 'risk of locoregional failure', 'CILP (primary end point) and event-free (EFS) and overall survival', 'local progression (CILP', '5-year CILP, EFS, and OS rates', '5-year CILP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",47.0,0.0978828,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P = .0590), 47.0% ± 3.5% ( P = .0090), and 57.4% ± 3.5% ( P = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","[{'ForeName': 'Kevin X', 'Initials': 'KX', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'DuBois', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Stephan D', 'Initials': 'SD', 'LastName': 'Voss', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Geetika', 'Initials': 'G', 'LastName': 'Khanna', 'Affiliation': ""Department of Radiology, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Doski', 'Affiliation': ""Department of Surgery/Pediatric Surgery Division, University of Texas Health Science Center, San Rosa Children's Hospital, San Antonio, TX.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Geiger', 'Affiliation': ""Section of Pediatric Surgery, Department of Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA.""}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03316'] 2924,32530769,International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct.,"PURPOSE To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naïve advanced anal cancer to establish the optimal regimen. PATIENTS AND METHODS Patients who had not received systemic therapy for advanced anal cancer were randomly assigned 1:1 to intravenous cisplatin 60 mg/m 2 (day 1) plus FU 1,000 mg/m 2 (days 1-4) every 21 days or carboplatin (area under the curve, 5; day 1) plus paclitaxel 80 mg/m 2 (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. Primary end point was objective response rate (ORR). Primary and secondary end points were assessed in a hierarchic model to compare the regimens and pick the winner. RESULTS We conducted an international multicenter randomized phase II study in 60 centers between December 2013 and November 2017. Median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin plus FU and 45 to carboplatin plus paclitaxel. ORR was 57% (95% CI, 39.4% to 73.7%) for cisplatin plus FU versus 59% (95% CI, 42.1% to 74.4%) for carboplatin plus paclitaxel. More serious adverse events were noted in the cisplatin plus FU arm (62%) compared with the carboplatin plus paclitaxel arm (36%; P = .016). Median progression-free survival was 5.7 months (95% CI, 3.3 to 9.0 months) for cisplatin plus FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin plus paclitaxel. Median overall survival was 12.3 months for cisplatin plus FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin plus paclitaxel (hazard ratio, 2.00; 95% CI, 1.15 to 3.47; P = .014). CONCLUSION This is the first international randomized trial to our knowledge conducted in chemotherapy-naïve advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.",2020,Median overall survival was 12.3 months for cisplatin plus FU,"['60 centers between December 2013 and November 2017', 'Advanced Anal Cancer', 'International Rare Cancers Initiative', 'A total of 91 patients were randomly assigned: 46 to', 'chemotherapy-naïve advanced anal cancer', 'Patients who had not received systemic therapy for advanced anal cancer']","['paclitaxel', 'cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel', 'carboplatin', 'carboplatin plus paclitaxel', 'cisplatin plus FU', 'Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel', 'intravenous cisplatin 60 mg/m 2 (day 1) plus FU 1,000 mg/m 2', 'cisplatin plus FU and 45 to carboplatin plus paclitaxel']","['Median overall survival', 'Median progression-free survival', 'objective response rate (ORR', 'toxicity', 'ORR', 'hierarchic model to compare the regimens and pick the winner', 'serious adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",91.0,0.183791,Median overall survival was 12.3 months for cisplatin plus FU,"[{'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sclafani', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adams', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Marianne G', 'Initials': 'MG', 'LastName': 'Guren', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segelov', 'Affiliation': 'Monash Health and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Amitesh', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Matt T', 'Initials': 'MT', 'LastName': 'Seymour', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Welch', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Cancer Centre, Manchester, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Dwyer"", 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Shree', 'Initials': 'S', 'LastName': 'Bhide', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Hamburg University Medical Centre, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03266'] 2925,32530814,An internet-based intervention to face stress during social isolation with guided relaxation and meditation: protocol for a randomized controlled study.,"BACKGROUND Psychophysiological stress and lower well-being are becoming a relevant issue during prolonged social isolation periods. Relaxation practices might represent helpful exercises to cope with anxiety and stressful sensations. OBJECTIVE The aim of the present research protocol is to test whether remote relaxation practices like natural sounds, deep respiration, and body scan may promote relaxation and emotional state, and reduce psychomotor activation and the preoccupation related to the COVID-19 pandemics. METHODS The study consists of 3 experimental groups which will randomly receive online audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to one of the fully automated audio clips for 7 minutes and pre-post complete self-assessed scales on perceived relaxation, psychomotor activation, level of worries associated with COVID-19 and emotional state. At the end of the session, qualitative reports on subjective experience will be asked too. RESULTS Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state. CONCLUSIONS The study will provide information on if and to what extent guided practices can help in reducing psychological side-effects related to COVID-19 social isolation. CLINICALTRIAL ",2020,"RESULTS Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state. ",['252 subjects (84 per group'],"['online audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds', 'audio clips']","['relaxation, psychomotor activation, level of worries associated with COVID-19 and emotional state']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",252.0,0.031618,"RESULTS Analysis will test the difference in efficacy between audio clips in an internet-based intervention on 252 subjects (84 per group), investigating whether natural sounds or remote guided practices like deep respiration and body scan enhance in a positive way the perceived psychological state. ","[{'ForeName': 'Silvia Maria Francesca', 'Initials': 'SMF', 'LastName': 'Pizzoli', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, Milan, IT.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marzorati', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology IEO IRCCS, Milan, IT.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, Milan, IT.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, Milan, IT.'}]",JMIR research protocols,['10.2196/19236'] 2926,32530836,The Feasibility of Using Comic-Based Concussion Discharge Instructions: Gauging Likeability and Knowledge Improvement Among Adolescents and Parents.,"OBJECTIVE The objective of this study was to evaluate feasibility of supplementing emergency department (ED) concussion discharge instructions for adolescents and parents with a newly created educational comic and a publicly available comic-based video at an outpatient sports neurology clinic. METHODS We created a gender-neutral, 2-page comic to augment text-only ED concussion discharge instructions. A sample of patients evaluated at a sports neurology clinic and their parents/guardians participated. Patients and their parents were randomized to view either the comic only or both the comic and publicly available comic-based video. Patients and parents completed preintervention and postintervention surveys to assess likeability and concussion knowledge including concussion definition, symptoms, return-to-ED criteria, and resuming normal activity. Data were analyzed using descriptive and comparative statistics. RESULTS A total of 57 patients (47.4% female; mean age, 15 years) and 37 guardians were enrolled. Most (73%) concussions were sports related, with the majority having sought care within 24 hours in an ED (80%). Over half (51%) had experienced 2 or more prior concussions. Overall, 31 adolescents and 20 guardians viewed both comic and video, whereas 26 adolescents and 17 guardians viewed the comic only. Both comic and video were favorably reviewed, but a higher proportion of respondents rated the video more positively than the comic for likability (P < 0.01), comprehensibility (P < 0.05), and increasing understanding (P < 0.05). Patients' knowledge of some concussion symptoms emphasized in the comic increased after reading (emotional changes, P = 0.02; vomiting, P = 0.04). CONCLUSIONS Patients showed increased concussion knowledge using the favorably endorsed comic-based discharge instructions. Using comic-based supplemental discharge tools may optimize concussion education for adolescents.",2020,"Patients' knowledge of some concussion symptoms emphasized in the comic increased after reading (emotional changes, P = 0.02; vomiting, P = 0.04). ","['57 patients (47.4% female; mean age, 15 years) and 37 guardians were enrolled', 'adolescents and parents with a newly created educational comic and a publicly available comic-based video at an outpatient sports neurology clinic', 'Adolescents and Parents', 'A sample of patients evaluated at a sports neurology clinic and their parents/guardians participated', 'adolescents', '31 adolescents and 20 guardians viewed both comic and video, whereas 26 adolescents and 17 guardians viewed the comic only']","['Comic-Based Concussion Discharge Instructions', 'supplementing emergency department (ED) concussion discharge instructions']","['likeability and concussion knowledge including concussion definition, symptoms, return-to-ED criteria, and resuming normal activity', 'concussion knowledge', 'comprehensibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",57.0,0.0623314,"Patients' knowledge of some concussion symptoms emphasized in the comic increased after reading (emotional changes, P = 0.02; vomiting, P = 0.04). ","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kolberg', 'Affiliation': 'From the Department of Emergency Medicine and University of Michigan Medical School.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Larson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine University of Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ichesco', 'Affiliation': 'Pediatrics, Michigan Medicine University of Michigan.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine University of Michigan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van Tubbergen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine University of Michigan.'}, {'ForeName': 'Bella S', 'Initials': 'BS', 'LastName': 'Nagappan', 'Affiliation': 'Department of Emergency Medicine, Michigan Medicine University of Michigan.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Saleem', 'Affiliation': 'Department of Emergency Medicine, University of Michigan.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Cranford', 'Affiliation': 'Department of Emergency Medicine, Michigan Medicine University of Michigan.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hashikawa', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Michigan Medicine University of Michigan, Ann Arbor, MI.'}]",Pediatric emergency care,['10.1097/PEC.0000000000002133'] 2927,32530869,"The Effect of Foot Reflexology Applied Before Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty on Anxiety, Stress, and Cortisol Levels of Individuals: A Randomized Controlled Trial.","BACKGROUND Coronary angiography and percutaneous transluminal coronary angioplasty procedures cause anxiety and stress in individuals. OBJECTIVE The aim of this study was to determine the effect of foot reflexology applied before coronary angiography and percutaneous transluminal coronary angioplasty on the anxiety, stress, and cortisol levels of individuals. METHODS A simple randomized trial design was used. The patients who met the inclusion criteria were divided into 4 groups including experimental and control groups of coronary angiography patients (30 patients in each group) and percutaneous transluminal coronary angioplasty (26 patients in each group) by randomization method. Data were collected with the State-Trait Anxiety Inventory and Distress Thermometer 90 minutes before coronary angiography and percutaneous transluminal coronary angioplasty and the laboratory samples were taken. After these procedures, foot reflexology was applied to both feet of the patients in the experimental group for 30 minutes, and the control group received only standard care. The inventories were reapplied 30 minutes after the reflexology application and after coronary angiography and percutaneous transluminal coronary angioplasty. RESULTS Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001) 30 minutes after reflexology application and after coronary angiography and percutaneous transluminal coronary angioplasty. After the reflexology, anxiety and stress scores were significantly lower in the experimental group compared with the control group (P < .001). Whereas there was a significant difference (P < .001) in the within-group cortisol values of both reflexology groups, no significant difference was found in the control groups (P > .05). CONCLUSIONS The application of reflexology before coronary angiography and percutaneous transluminal coronary angioplasty reduces the levels of anxiety, stress, and cortisol without any side effects.",2020,"Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001)","['individuals', 'Individuals']","['Coronary angiography and percutaneous transluminal coronary angioplasty procedures', 'coronary angiography patients', 'control group received only standard care', 'percutaneous transluminal coronary angioplasty', 'Foot Reflexology Applied Before Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty', 'foot reflexology applied before coronary angiography and percutaneous transluminal coronary angioplasty', 'coronary angiography and percutaneous transluminal coronary angioplasty']","['levels of anxiety, stress, and cortisol without any side effects', 'Anxiety Inventory and stress median scores', 'anxiety, stress, and cortisol levels', 'Anxiety, Stress, and Cortisol Levels', 'anxiety and stress scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C2936173', 'cui_str': 'Percutaneous transluminal coronary angioplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",,0.017879,"Whereas there was no statistically significant difference (P > .05) between the coronary angiography and percutaneous transluminal coronary angioplasty experimental and control groups in Anxiety Inventory and stress median scores before reflexology, a significant difference was found (P < .001)","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Birgül Vural Doğru, PhD, RN Assistant Professor, Internal Medicine Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey. Fisun Şenuzun Aykar, PhD, RN Professor, Internal Medicine Nursing Department, Faculty of Nursing, Ege University, Izmir, Turkey. Yasemin Yıldırım, PhD, RN Professor, Internal Medicine Nursing Department, Faculty of Nursing, Ege University, Izmir, Turkey. Oğuz Yavuzgil, MD, PhD Professor, Cardiology Department, Faculty of Medicine, Ege University, Izmir, Turkey. Eser Sözmen, MD, PhD Professor, Medical Biochemistry Department, Faculty of Medicine, Ege University, Izmir, Turkey. Hikmet Memmedov, PhD Medical Biochemistry Department, Faculty of Medicine, Ege University, Izmir, Turkey.'}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'ŞenuzunAykar', 'Affiliation': ''}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Yıldırım', 'Affiliation': ''}, {'ForeName': 'Oğuz', 'Initials': 'O', 'LastName': 'Yavuzgil', 'Affiliation': ''}, {'ForeName': 'Eser', 'Initials': 'E', 'LastName': 'Sözmen', 'Affiliation': ''}, {'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Memmedov', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000700'] 2928,32530874,"Focused Shockwave Treatment for Greater Trochanteric Pain Syndrome: A Multicenter, Randomized, Controlled Clinical Trial.","BACKGROUND Greater trochanteric pain syndrome (GTPS) is a condition of lateral hip pain. Its physiopathology remains unknown, and there is no consensus on optimal management. The aim of this study was to assess the effectiveness of electromagnetic-focused extracorporeal shockwave treatment (F-ESWT) in patients with GTPS. METHODS This multicenter clinical trial included 103 patients with chronic GTPS randomly assigned to the treatment group, consisting of electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol. Both groups were treated with 3 weekly sessions; the F-ESWT group received an energy flux density of 0.20 mJ/mm, whereas the control group received 0.01 mJ/mm. Patients were assessed at baseline and 1, 2, 3, and 6 months after treatment. A visual analogue scale (VAS) score for pain at 2 months was the primary outcome. The Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score were used as secondary outcomes. Complications were recorded. RESULTS The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001). All secondary outcomes at all follow-up intervals were significantly better in the F-ESWT group, except for the LEFS score at 1 month after treatment (p = 0.25). No complications were observed. CONCLUSIONS F-ESWT in association with a specific exercise program is safe and effective for GTPS, with a success rate of 86.8% at 2 months after treatment, which was maintained until the end of follow-up. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001).,"['patients with GTPS', '103 patients with chronic GTPS', 'Greater Trochanteric Pain Syndrome']","['Shockwave Treatment', 'electromagnetic F-ESWT and a specific exercise protocol, or the control group, receiving sham F-ESWT and the same exercise protocol', 'electromagnetic-focused extracorporeal shockwave treatment (F-ESWT']","['mean VAS score', 'visual analogue scale (VAS) score for pain', 'LEFS score', 'Harris hip score (HHS), Lower Extremity Functional Scale (LEFS), EuroQoL-5 Dimensions Questionnaire (EQ-5D), and Roles and Maudsley score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4305124', 'cui_str': 'Lower Extremity Functional Scale score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",103.0,0.126826,The mean VAS score decreased from 6.3 at baseline in both groups to 2.0 in the F-ESWT group versus 4.7 in the control group at 2 months; the 2-month score differed significantly between groups (p < 0.001).,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ramon', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Russo', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Santoboni', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Lucenteforte', 'Affiliation': 'Policlinico Vittorio Emanuele, Università degli Studi di Catania, Catania. Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Di Luise', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de Unzurrunzaga', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Vetrano', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Mariantonia', 'Initials': 'M', 'LastName': 'Albano', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rosella', 'Initials': 'R', 'LastName': 'Baldini', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Cugat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stella', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Balato', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Seijas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation (PMR) (S. Ramon and R.d.U.) and Department of Orthopedic Surgery, Instituto Cugat (R.C. and R.S.), Quirónsalud Hospital, Barcelona, Spain.'}, {'ForeName': 'Sveva-Maria', 'Initials': 'SM', 'LastName': 'Nusca', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Servodidio', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maria-Chiara', 'Initials': 'MC', 'LastName': 'Vulpiani', 'Affiliation': 'Physical Medicine and Rehabilitation (F.S., M.V., R.B., G.S., S.-M.N., and M.-C.V.), and Department of Statistics (R.B.), Sapienza University School of Medicine, Rome, Italy.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00093'] 2929,32530908,Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials: Erratum.,,2020,,['Antiretroviral Treatment-Naive Adults With HIV-1 Infection'],['Dolutegravir Plus Lamivudine'],['Durable Efficacy'],"[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.146493,,[],Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002394'] 2930,32531302,Wound Eversion Versus Planar Closure for Wounds on the Face or Neck: A Randomized Split-Wound Comparative Effectiveness Trial.,,2020,,['Wounds on the Face or Neck'],['Wound Eversion Versus Planar Closure'],[],"[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.024742,,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Alexanian', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, CA; Georgetown University School of Medicine, Washington DC.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Milene', 'Initials': 'M', 'LastName': 'Crispin', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, University of Southern California, Los Angeles.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, CA. Electronic address: deisen123@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.013'] 2931,32531393,"Erratum to: Britton B, Baker AL, Wolfenden L, Wratten C, Bauer J, Beck AK, McCarter K, Harrowfield J, Isenring E, Tang C, Oldmeadow C, and Carter G. Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Int J Radiat Oncol Biol Phys 2019.",,2020,,['Patients With Head and Neck Cancer Undergoing Radiation Therapy'],['Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0400018,,[],"International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.010'] 2932,32531428,Impact of acute inflammation on the extinction of aversive gut memories.,"Impaired extinction of pain-related fear memories can lead to persistent or resurging fear of pain, contributing to the development and maintenance of chronic pain conditions. The mechanisms underlying maladaptive pain-related learning and memory processes remain incompletely understood, particularly in the context of interoceptive, visceral pain. Inflammation is known to interfere with learning and memory, but its effects on the extinction of pain-related fear memories have never been tested. In a randomized, double-blind, placebo-controlled study, we assessed the impact of experimental acute inflammation on the extinction and reinstatement of conditioned visceral pain-related fear. Forty healthy male volunteers underwent differential fear conditioning with visceral pain as clinically relevant unconditioned stimulus (US). Participants then received an intravenous injection of either 0.8ng/kg lipopolysaccharide (LPS) as inflammatory stimulus or physiological saline as placebo, and extinction training was conducted at the peak of the inflammatory response. Extinction recall and reinstatement tests were performed after overnight consolidation. Results showed that visceral pain represents an effective US, eliciting pronounced conditioned pain-related fear responses. Repeated unreinforced presentation of the pain-predictive cue during extinction training resulted in full extinction of the conditioned behavioral response. However, unexpected re-exposure to the US during reinstatement test resulted in return of fear. Despite pronounced LPS-induced effects on inflammatory markers, cortisol, and negative affect, we did not find evidence that acute inflammation resulted in altered fear extinction. The findings support the notion that visceral pain-related fear learning establishes a robust aversive memory trace that remains preserved during inhibitory learning, leaving a latent vulnerability for the return of fear. Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.",2020,"Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.","['Forty healthy male volunteers', 'healthy individuals with no additional vulnerability factors']","['intravenous injection of either 0.8ng/kg lipopolysaccharide (LPS) as inflammatory stimulus or physiological saline as placebo, and extinction training', 'extinction training', 'differential fear conditioning with visceral pain as clinically relevant unconditioned stimulus (US', 'placebo']","['full extinction of the conditioned behavioral response', 'return of fear', 'conditioned pain-related fear responses', 'extinction of aversive gut memories']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0234245', 'cui_str': 'Visceral pain'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",40.0,0.101091,"Inflammation during inhibitory learning did neither weaken nor further amplify this aversive memory trace, suggesting that it is rather resistant to acute inflammation-induced effects, at least in healthy individuals with no additional vulnerability factors.","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rebernik', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pastoors', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brinkhoff', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wegner', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany; Department of Orthopaedics, Trauma and Reconstructive Surgery, Marienhospital Mülheim an der Ruhr, Germany.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Elsenbruch', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany; Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Germany. Electronic address: harald.engler@uk-essen.de.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.009'] 2933,32531482,A feasibility study of a randomised controlled trial of asthma-tailored pulmonary rehabilitation compared with usual care in adults with severe asthma.,"BACKGROUND Currently the acceptability and efficacy of pulmonary rehabilitation (PR) for adults with severe asthma is unknown. OBJECTIVE We investigated the feasibility of performing a randomised controlled trial of asthma-tailored PR (AT-PR) versus usual care (UC). METHODS Adults with severe asthma were recruited and randomised 2:1 to AT-PR:UC. The primary outcomes were recruitment, retention and serious adverse event rates (SAE). Secondary outcome measures included those for a future trial assessing the feasibility of collecting data. Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control. A recruitment rate of 30% was estimated with 95%CI of ±7%, a retention rate of 75% ±14% if we recruited 40 patients to AT-PR, and a SAE rate of 2.5%. RESULTS 61/238 (26%) eligible patients were recruited: 38 females, mean (SD) age 54 (13)years, BMI 32 (7)kg/m 2 , FEV 1 1.9 (0.7)L, FEV 1 /FVC 69 (11)%. 51 were randomised to either AT-PR (n=34) or UC (n=17). The retention rates were AT-PR 62%,UC 53% with a SAE rate of 3.3% related to the study visits. Overall collection of the outcome measures was feasible. The results were suggestive of improvements in exercise performance, HRQoL and asthma control with AT-PR compared to UC. CONCLUSION Both recruitment and retention rates were within the a priori estimated 95%CI. Our results indicate AT-PR may be efficacious for adults with severe asthma but any future intervention and trial design would need further modifications to improve acceptability and retention rate.",2020,"Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control.","['eligible patients were recruited: 38 females, mean (SD) age 54 (13)years, BMI 32 (7)kg/m 2 , FEV 1 1.9 (0.7)L', 'Adults with severe asthma', 'adults with severe asthma']","['asthma-tailored PR (AT-PR) versus usual care (UC', 'FVC 69', 'usual care', 'asthma-tailored pulmonary rehabilitation', 'UC', 'pulmonary rehabilitation (PR']","['exercise performance, HRQoL and asthma control with AT-PR', 'physical performance, health-related quality of life (HRQoL), and asthma control', 'acceptability and retention rate', 'retention rates', 'retention rate', 'feasibility of collecting data', 'recruitment, retention and serious adverse event rates (SAE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.171781,"Assessments were performed at baseline, 12 weeks and nine months including measures of physical performance, health-related quality of life (HRQoL), and asthma control.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Majd', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK; Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Apps', 'Affiliation': 'Institute for Psychological Sciences, Faculty of Health & Life Sciences.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Chantrell', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre - Respiratory Theme.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Centre for Reproduction Research, Applied Social Science, DeMontfort University, Leicester, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eglington', 'Affiliation': 'Patient representative.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Hargadon', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre - Respiratory Theme.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK; Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK; Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Ruth H', 'Initials': 'RH', 'LastName': 'Green', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK; Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Evans', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK; Leicester NIHR, Biomedical Research Centre - Respiratory Theme; Department of Respiratory Medicine, Thoracic Surgery and Allergy, Glenfield Hospital, Leicester, UK. Electronic address: re66@leicester.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.05.052'] 2934,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries. METHODS AND MATERIALS In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS. RESULTS Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05). CONCLUSION Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588'] 2935,32531968,Influence of Music on Closed Motor Skills: A Controlled Study with Novice Female Dart-Throwers.,"The influence of music heard at different tempos is analyzed during the execution of a dart-throwing task. The sample consisted of 56 female university students (Mean age = 23.38, SD = 6.773). The participants were randomly assigned to GC (group control without music; n = 18), GS (group with slow-paced music at a tempo of 60 BPM; n = 19) and GF (group with fast-paced music at a tempo of 105 BPM; n = 19). All participants performed a dart-throwing task in two phases. Analysis of the scores obtained during Phase 1 and Phase 2 of dart throwing (examining both between-group differences and within-group differences, i.e., changes in scores from Phase 1 to Phase 2 using a mixed factorial ANOVA) revealed no differences in dart-throwing scores. There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC. The results are discussed in terms of the role of music in precision tasks and the synchronization of the task with the pace of the music .",2020,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC.","['56 female university students (Mean age = 23.38, SD = 6.773', 'Novice Female Dart-Throwers']","['GC', 'Music', 'GS (group with slow-paced music at a tempo of 60 BPM; n = 19) and GF (group with fast-paced music']","['Closed Motor Skills', 'execution time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336707', 'cui_str': 'Dart'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0076082', 'cui_str': 'tempamine'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0510927,"There were, however, differences in execution time, where the participants in GS needed more time to complete the task than those in GF ( F (2 , 55) = 4.426, p = 0.017) with a large effect size ( ŋ 2 p = 0.143), although neither of these groups differed from GC.","[{'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Arbinaga', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Nehemías', 'Initials': 'N', 'LastName': 'Romero-Pérez', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torres-Rosado', 'Affiliation': 'Department of Clinical and Experimental Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Fernández-Ozcorta', 'Affiliation': 'Department of Physical Activity and Sports, Center for University Studies Cardenal Spínola CEU, University of Seville Attached Centre, 41930 Sevilla, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mendoza-Sierra', 'Affiliation': 'Department of Social, Evolutionary and Educational Psychology, Faculty of Education, Psychology and Sports Science, University of Huelva, 21007 Huelva, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17114146'] 2936,32531982,"Intestinal Permeability in Children with Celiac Disease after the Administration of Oligofructose-Enriched Inulin into a Gluten-Free Diet-Results of a Randomized, Placebo-Controlled, Pilot Trial.","Abnormalities in the intestinal barrier are a possible cause of celiac disease (CD) development. In animal studies, the positive effect of prebiotics on the improvement of gut barrier parameters has been observed, but the results of human studies to date remain inconsistent. Therefore, this study aimed to evaluate the effect of twelve-week supplementation of a gluten-free diet (GFD) with prebiotic oligofructose-enriched inulin (10 g per day) on the intestinal permeability in children with CD treated with a GFD. A pilot, randomized, placebo-controlled nutritional intervention was conducted in 34 children with CD, being on a strict GFD. Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured. We found that the supplementation with prebiotic did not have a substantial effect on barrier integrity. Prebiotic intake increased excretion of mannitol, which may suggest an increase in the epithelial surface. Most children in our study seem to have normal values for intestinal permeability tests before the intervention. For individuals with elevated values, improvement in calprotectin and SAT was observed after the prebiotic intake. This preliminary study suggests that prebiotics may have an impact on the intestinal barrier, but it requires confirmation in studies with more subjects with ongoing leaky gut.",2020,"Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured.","['subjects with ongoing leaky gut', 'children with CD treated with a GFD', '34 children with CD, being on a strict GFD', 'Children with Celiac Disease after the Administration of Oligofructose-Enriched Inulin into a Gluten-Free Diet']","['placebo-controlled nutritional intervention', 'Placebo', 'gluten-free diet (GFD) with prebiotic oligofructose-enriched inulin']","['calprotectin and SAT', 'Intestinal Permeability', 'barrier integrity', 'Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914216', 'cui_str': 'zonulin'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}]",34.0,0.205677,"Sugar absorption test (SAT) and the concentrations of intestinal permeability markers, such as zonulin, intestinal fatty acid-binding protein, claudin-3, calprotectin, and glucagon-like peptide-2, were measured.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Drabińska', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, 10-748 Olsztyn, Poland.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Krupa-Kozak', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, 10-748 Olsztyn, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology, and Nutrition, Collegium Medicum, University of Warmia & Mazury, 10-719 Olsztyn, Poland.'}]",Nutrients,['10.3390/nu12061736'] 2937,32531990,Changes in Plasma Itaconate Elevation in Early Rheumatoid Arthritis Patients Elucidates Disease Activity Associated Macrophage Activation.,"Changes in the plasma metabolic profile were characterised in newly diagnosed rheumatoid arthritis (RA) patients upon commencement of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. Plasma samples collected in an early RA randomised strategy study (NCT00920478) that compared clinical (DAS) disease activity assessment with musculoskeletal ultrasound assessment (MSUS) to drive treatment decisions were subjected to untargeted metabolomic analysis. Metabolic profiles were collected at pre- and three months post-commencement of nonbiologic cDMARD. Metabolites that changed in association with changes in the DAS44 score were identified at the three-month timepoint. A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP). cDMARD treatment effects invoke consistent changes in plasma detectable metabolites, that in turn implicate clinical disease activity with macrophages. Such changes inform RA pathogenesis and reveal for the first time a link between itaconate production and resolution of inflammatory disease in humans. Quantitative metabolic biomarker-based tests of clinical change in state are feasible and should be developed around the itaconate pathway.",2020,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).",['Early Rheumatoid Arthritis Patients'],['musculoskeletal ultrasound assessment (MSUS'],"['DAS44 score', 'Metabolic profiles', 'plasma metabolic profile', 'DAS44 score and decreasing levels of C-reactive protein (CRP', 'Plasma Itaconate Elevation']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0124235', 'cui_str': 'itaconate'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",9.0,0.0271239,"A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP).","[{'ForeName': 'Rónán', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Carl S', 'Initials': 'CS', 'LastName': 'Goodyear', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Manikhandan', 'Initials': 'M', 'LastName': 'Mudaliar', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Burgess', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Stirling', 'Affiliation': 'Department of Rheumatology, Gartnavel General Hospital, Glasgow G12 0YN, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Porter', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Barrett', 'Affiliation': 'Glasgow Polyomics, University of Glasgow, Glasgow G61 1BD, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.'}]",Metabolites,['10.3390/metabo10060241'] 2938,32532035,Anti-Inflammatory Potential of n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption in Improving Microvascular Endothelial Function of Healthy Individuals-Clinical Trial.,"The effects of consumption of n-3 polyunsaturated fatty acids (n-3 PUFAs) enriched hen eggs on endothelium-dependent and endothelium-independent vasodilation in microcirculation, and on endothelial activation and inflammation were determined in young healthy individuals. Control group ( N = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053 g n-3 PUFAs/day) for 3 weeks. Skin microvascular blood flow in response to iontophoresis of acetylcholine (AChID; endothelium-dependent) and sodium nitroprusside (SNPID; endothelium-independent) was assessed by laser Doppler flowmetry. Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers were measured before and after respective dietary protocol. Results: Serum n-3 PUFAs concentration significantly increased, AChID significantly improved, and SNPID remained unchanged in n-3 PUFAs group, while none was changed in Control group. Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs. BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A significantly increased in the Control group. Other measured parameters remained unchanged in both groups. Favorable anti-inflammatory properties of n-3 PUFAs consumption potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals.",2020,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"['young healthy individuals', 'Healthy Individuals-Clinical Trial', 'healthy individuals']","['n-3 PUFAs consumption', 'Control group ( N = 21) ate three regular hen eggs/daily (249 mg n-3 PUFAs/day), and n-3 PUFAs group ( N = 19) ate three n-3 PUFAs enriched hen eggs/daily (1053', 'acetylcholine', 'n-3 polyunsaturated fatty acids (n-3 PUFAs', 'Interferon-γ', 'n-3 Polyunsaturated Fatty Acids Enriched Hen Eggs Consumption']","['Blood pressure (BP), body composition, body fluid status, serum lipid and free fatty acids profile, and inflammatory and endothelial activation markers', 'interleukin-10 (anti-inflammatory', 'BP, fat free mass, and total body water significantly decreased, while fat mass, interleukin-17A (pro-inflammatory), interleukin-10 and vascular endothelial growth factor A', 'Microvascular Endothelial Function', 'Serum n-3 PUFAs concentration', 'Skin microvascular blood flow', 'SNPID']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0187711,Interferon-γ (pro-inflammatory) significantly decreased and interleukin-10 (anti-inflammatory) significantly increased in n-3 PUFAs.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mihalj', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Kolobarić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Šušnjara', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Luka', 'Initials': 'L', 'LastName': 'Kolar', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zrinka', 'Initials': 'Z', 'LastName': 'Mihaljević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Matić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Stupin', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jukić', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Zlata', 'Initials': 'Z', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Grčević', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Gordana', 'Initials': 'G', 'LastName': 'Kralik', 'Affiliation': 'Scientific Center of Excellence for Personalized Health Care, Josip Juraj Strossmayer University of Osijek, Trg Svetog Trojstva 3, Hr-31000 Osijek, Croatia.'}, {'ForeName': 'Vatroslav', 'Initials': 'V', 'LastName': 'Šerić', 'Affiliation': 'Department of Clinical Laboratory Diagnostics, Osijek University Hospital, J. Huttlera 4, HR-31000 Osijek, Croatia.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Drenjančević', 'Affiliation': 'Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek, J. Huttlera 4, HR-31000 Osijek, Croatia.'}]",International journal of molecular sciences,['10.3390/ijms21114149'] 2939,32531115,"Efficacy of cold atmospheric plasma versus diclofenac 3% gel in patients with actinic keratoses: a prospective, randomized, and rater-blinded study (ACTICAP).","Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development. Conventional therapies bear significant side effects and/or are limited to small treatment areas. Thus, there is a continuing need for nontoxic lesion- and field-directed treatment options for extensive AK. Cold atmospheric plasma (CAP) is a partially ionized gas containing a mixture of reactive oxygen and nitrogen species. In addition to its well-documented antimicrobial properties, growing evidence points to antitumor effects 1 . Anecdotal observations suggest promising clinical response of AK treated with various CAP devices 2, 3 . However, confirmatory clinical studies comparing the efficacy of CAP with conventional therapies are lacking.",2020,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"['Actinic keratoses (AK', 'patients with actinic keratoses']","['Cold atmospheric plasma (CAP', 'CAP', 'cold atmospheric plasma versus diclofenac']",[],"[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]",[],,0.0942484,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Koch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Salva', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wirtz', 'Affiliation': 'SanaSkin, Zürich, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Varaljai', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roesch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16735'] 2940,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet. METHODS We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques. RESULTS All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Peking University School and Hospital of Stomatology, Beijing 100081, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018'] 2941,32531762,Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT).,"BACKGROUND The purpose of this study was to evaluate the feasibility and effectiveness of a high-intensity semisupervised exercise program alongside lifestyle counseling as an intervention for managing cardiometabolic risk in sedentary adults. METHODS A 40-week 3-arm randomized controlled clinical trial (16-wk intervention and 24-wk follow-up) was used. Seventy-five sedentary adults (34-55 y) with at least 1 cardiometabolic risk factor were randomized into one of the following arms: (1) aerobic interval training (AIT) plus lifestyle counseling (n = 25), (2) low- to moderate-intensity continuous training plus lifestyle counseling (traditional continuous training, TCT) (n = 27), or (3) lifestyle counseling alone (COU) (n = 23). Metabolic syndrome severity scores, accelerometer-based physical activity, and self-reported dietary habits were assessed at baseline, after the intervention, and at follow-up. RESULTS AIT was well accepted with high enjoyment scores. All groups showed similar improvements in metabolic syndrome severity scores (standardized effect size = 0.46) and dietary habits (standardized effect size = 0.30). Moderate to vigorous physical activity increased in all study groups, with the number of responders higher in AIT and TCT groups (50%) than in COU group (21%). Both AIT and TCT had a greater impact on sedentary behavior than COU (63.5% vs 30.4% responders). CONCLUSIONS AIT appears to be a feasible and effective strategy in sedentary individuals with cardiometabolic risk factors. AIT could be included in intervention programs tackling unhealthy lifestyles.",2020,"Moderate to vigorous physical activity increased in all study groups, with the number of responders higher in AIT and TCT groups (50%) than in COU group (21%).","['n = 27), or (3', 'sedentary individuals with cardiometabolic risk factors', 'sedentary adults', 'Seventy-five sedentary adults (34-55\xa0y) with at least 1 cardiometabolic risk factor', 'Sedentary Adults']","['2)\xa0low- to moderate-intensity continuous training plus lifestyle counseling (traditional continuous training, TCT', 'high-intensity semisupervised exercise program alongside lifestyle counseling', 'lifestyle counseling alone (COU', 'Semisupervised Physical Exercise and Lifestyle Counseling', 'aerobic interval training (AIT) plus lifestyle counseling']","['vigorous physical activity', 'metabolic syndrome severity scores', 'sedentary behavior', 'dietary habits', 'Metabolic syndrome severity scores, accelerometer-based physical activity, and self-reported dietary habits']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",75.0,0.04797,"Moderate to vigorous physical activity increased in all study groups, with the number of responders higher in AIT and TCT groups (50%) than in COU group (21%).","[{'ForeName': 'Assumpta', 'Initials': 'A', 'LastName': 'Ensenyat', 'Affiliation': ''}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Espigares-Tribo', 'Affiliation': ''}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Machado-Da-Silva', 'Affiliation': ''}, {'ForeName': 'Xenia', 'Initials': 'X', 'LastName': 'Sinfreu-Bergués', 'Affiliation': ''}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Blanco', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0409'] 2942,32531798,"Long-Term Safety of Certolizumab Pegol in Plaque Psoriasis: Pooled Analysis over 3 Years from Three Phase 3, Randomised, Placebo-Controlled Studies.","BACKGROUND Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. OBJECTIVE Report three-year safety from three phase 3 trials of CZP in adults with plaque psoriasis (PSO). METHODS Data were pooled from CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272), CIMPACT (NCT02346240). Included patients: had moderate to severe PSO ≥6 months; were randomised to CZP 200 mg every two weeks (Q2W) (400 mg at Weeks 0, 2, 4) or CZP 400 mg Q2W; received ≥1 dose CZP with up to 144 weeks' exposure. Treatment-emergent adverse events (TEAEs) were classified using MedDRAv18.1. Reported incidence rates (IRs) are incidence of new cases/100 patient-years (PY). RESULTS Over 144 weeks, 995 patients received ≥1 dose CZP (exposure: 2,231.3 PY); 731 and 728 received ≥1 dose CZP 200 mg Q2W (1,211.4 PY) and 400 mg Q2W (1,019.9 PY), respectively. IR (95% confidence interval [CI]) of TEAEs was 144.9 (135.3-155.0) for all patients; 134.1 (123.2-145.7) and 158.3 (145.5-171.9) for CZP 200 mg and 400 mg Q2W, respectively. IR of serious TEAEs for all patients was 7.5 (6.4-8.8); 6.7 (5.2-8.3) and 8.7 (6.9-10.8) for CZP 200 mg and 400 mg Q2W, respectively. 3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was 1 case of active tuberculosis, 16 malignancies in 14 patients and 7 deaths (2 considered treatment-related). Cumulative IR of TEAEs did not increase over time. CONCLUSIONS No new safety signals were identified compared to previously reported data. Risk did not increase with longer or higher CZP exposure.",2020,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"['Plaque Psoriasis', 'Included patients: had moderate to severe PSO ≥6 months', 'adults with plaque psoriasis (PSO', '995 patients received ≥1 dose CZP (exposure: 2,231.3 PY); 731 and 728 received']","['Placebo', 'CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP', 'Certolizumab pegol (CZP', '≥1 dose CZP 200 mg Q2W']","['serious infections', 'Cumulative IR of TEAEs']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",995.0,0.282486,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van de Kerkhof', 'Affiliation': 'Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Nova Scotia, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arendt', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Centre for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19314'] 2943,32531816,Formulation and efficacy evaluation of the safe and efficient moisturizing snow mushroom hand sanitizer.,"OBJECTIVES Snow fungus or snow mushroom or white jelly mushroom (Tremella fuciformis), the edible mushroom, was formulated into hand sanitizer in form of moisturizing alcohol-based hand rubs (ABHR) gel. METHODS The stable base ABHRs were developed. The preferred bases were incorporated with various concentrations of snow mushroom extract. The stable and preferred snow mushroom ABHR was moisturizing and sanitizing efficacies evaluated in 20 human volunteers in a comparison with its placebo. RESULTS The stable hand sanitizer gel bases containing 66.5% of ethanol and 0.3% triclosan were developed and incorporated with the extract of snow mushroom polysaccharide. Of which, the preparations containing 10% of snow mushroom and 0.3% of gelling agent gained the highest preferences as assessed in 20 Thai volunteers. The snow mushroom hand sanitizer was proved to be none irritated in the same group of the volunteers as was the placebo. The snow mushroom gel significantly (P < 0.05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 min. The hand sanitizers were confirmed on their anti-septic, at which the efficacies of the active and placebo ABHR were comparable (P = 0.90). CONCLUSIONS Snow mushroom ABHR gel with its confirmed moisturizing and sanitizing efficacies is presented. It is meetings with the recommendation on hand hygienic improvement to combat the infections of diseases spreading. The preparation can be frequency applied with its proved skin hydrating efficacy co-contributes in a good condition of hand hygiene.",2020,The snow mushroom gel significantly (P < 0.05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 min.,"['20 human volunteers in a comparison with its placebo', '20 Thai volunteers']","['ethanol and 0.3% triclosan', 'Snow fungus or snow mushroom or white jelly mushroom (Tremella fuciformis), the edible mushroom, was formulated into hand sanitizer in form of moisturizing alcohol-based hand rubs (ABHR) gel', 'placebo']",[],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0001774', 'cui_str': 'Order Agaricales'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1330330', 'cui_str': 'Hand Antiseptics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],20.0,0.031813,The snow mushroom gel significantly (P < 0.05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 min.,"[{'ForeName': 'Nattaya', 'Initials': 'N', 'LastName': 'Lourith', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}, {'ForeName': 'Sathaporn', 'Initials': 'S', 'LastName': 'Pungprom', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Kanlayavattanakul', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, 57100, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13543'] 2944,32531956,Effect of a Six-Week Intermittent Fasting Intervention Program on the Composition of the Human Body in Women over 60 Years of Age.,"The objective of this research was to determine the effectiveness of intermittent fasting (IF) in reducing body fat and lowering body mass index. An additional objective was to determine the feasibility of applying IF in overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan. This study included a group of 45 women over 60 years of age. The intervention in the experimental group involved complete abstinence from food intake for 16 h per day, from 20:00 p.m. to 12:00 a.m. (the next day). The results demonstrated that the body weight in the subjects in the experimental group (EXP) group decreased by almost 2 kg and this decrease was visible in the remaining parameters related to body fat mass. The skeletal muscle mass did not change significantly, which indicates an actual decrease in the fat mass. The proportion of subjects who did not succeed in following the prescribed diet plan was 12%. The application of intermittent fasting in female subjects over 60 years of age resulted in positive changes in body composition. Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.",2020,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"['Women over 60 Years of Age', 'female subjects over 60 years of age resulted in positive changes in body composition', 'overweight women over 60 years of age, which was assessed by the ratio of subjects who resigned from the diet plan', '45 women over 60 years of age']",['Six-Week Intermittent Fasting Intervention Program'],"['body weight', 'body fat and lowering body mass index', 'Time-restricted feeding (TRF', 'skeletal muscle mass']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.0208379,Time-restricted feeding (TRF) was characterized by a lower resignation rate compared to other diets involving intermittent fasting.,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Domaszewski', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Konieczny', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Pakosz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Bączkowicz', 'Affiliation': 'Faculty of Physical Education and Physiotherapy, Opole University of Technology, 45-758 Opole, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Sadowska-Krępa', 'Affiliation': 'Institute of Sport Sciences, the Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17114138'] 2945,32532068,Beneficial Molecular Adaptations In BRCA -Mutation Carriers By Combined HIT/HIRT Intervention: Results From A Pilot Study.,": Based on growing evidence that breast cancer (BRCA) also plays a pivotal role in the regulation of skeletal muscle metabolism and the response to anti-oxidative stress, we examined the influence of regular exercise in human BRCA mutation carriers on their BRCA1 gene/protein expression and inflammatory/oxidative response. Sixteen BRCA -mutation carriers were assigned to an intervention (IG) or control group (CG). IG received a combination of high-intensity interval endurance (HIT) and strength training (HIRT) for six weeks, whereas CG received a low-intensity activity program. Before (T0) and at the end of the intervention (T1), muscle biopsy, physiological performance, blood withdrawal and anthropometry were obtained. Parameters included: Muscle BRCA1 gene/protein expression, inflammatory/oxidative stress, anti-oxidative capacity, peak oxygen capacity (VO 2 peak) and 1-repetition maximum (1-RM) at six different training machines. VO 2 peak and 1-RM of IG were increased at T1 compared to T0, whereas CG performance, physiological and molecular parameters remained unchanged. IG showed increased BRCA1 protein concentration as well as anti-oxidative capacity, whereas gene expression was unaltered. IG inflammatory and oxidative damage did not differ between time points. Combined HIT/HIRT increases aerobic and strength performance of BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.",2020,Combined HIT/HIRT increases aerobic and strength performance of BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.,['Sixteen BRCA -mutation carriers'],"['combination of high-intensity interval endurance (HIT) and strength training (HIRT', 'HIT/HIRT Intervention', 'Combined HIT/HIRT']","['muscle biopsy, physiological performance, blood withdrawal and anthropometry', 'IG inflammatory and oxidative damage', 'aerobic and strength performance', 'VO 2 peak and 1-RM of IG', 'CG performance, physiological and molecular parameters', 'Muscle BRCA1 gene/protein expression, inflammatory/oxidative stress, anti-oxidative capacity, peak oxygen capacity (VO 2 peak) and 1-repetition maximum (1-RM', 'BRCA1 protein concentration', 'inflammatory response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0259275', 'cui_str': 'Breast cancer type 1 susceptibility protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.037094,Combined HIT/HIRT increases aerobic and strength performance of BRCA -mutation carriers with up regulated BRCA1 protein expression and improved anti-oxidative status without showing an increased inflammatory response.,"[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Bizjak', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Sebastian V W', 'Initials': 'SVW', 'LastName': 'Schulz', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schumann', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Otto', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kirsten', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebner', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Leinert', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Ulm University Hospital, Department of Gynecology and Obstetrics, 89075 Ulm, Germany.'}, {'ForeName': 'Jürgen Michael', 'Initials': 'JM', 'LastName': 'Steinacker', 'Affiliation': 'Ulm University Hospital, Division of Sports and Rehabilitation Medicine, 89075 Ulm, Germany.'}]",Cancers,['10.3390/cancers12061526'] 2946,32532097,"A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults.","This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.",2020,The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events.,"['healthy adults of a new potential pandemic H7N9 live attenuated', 'Healthy Adults']","['Placebo', 'New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine', 'influenza vaccine (LAIV', 'H7N9 LAIV or placebo', 'placebo']","['frequency of shedding', 'Safety, Immunogenicity and Genetic Stability', 'immune response', 'rates of adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.409709,The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events.,"[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kiseleva', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Isakova-Sivak', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Stukova', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Erofeeva', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Donina', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Larionova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Krutikova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Bazhenova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Stepanova', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Vasilyev', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Matyushenko', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Krylova', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Galatonova', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Aleksey', 'Initials': 'A', 'LastName': 'Ershov', 'Affiliation': 'The Federal State Unitary Enterprise ""Scientific and Production Association for Immunological Preparations ""Microgen"", Ministry of Health of Russian Federation, 127473 Moscow, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Lioznov', 'Affiliation': 'Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.'}, {'ForeName': 'Erin Grace', 'Initials': 'EG', 'LastName': 'Sparrow', 'Affiliation': 'World Health Organization, 1211 Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Torelli', 'Affiliation': 'World Health Organization, 1211 Geneva, Switzerland.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Rudenko', 'Affiliation': 'Federal State Budgetary Scientific Institution ""Institute of Experimental Medicine"", 197376 St Petersburg, Russia.'}]",Vaccines,['10.3390/vaccines8020296'] 2947,32532098,"Improvement in Healthy Meal Index, Lunch Quality, and Diversity Scores Following an Integrated Nutritional Intervention in a Communal Dining Room: The NEKST Study.","The objective of the NEKST (Nutrition Environmental Kibbutzim Study), a nonrandomized interventional study, was to evaluate the effect of an integrated intervention program on participants' lunch quality and diversity in two communal dining rooms (intervention n = 58 vs. control n = 54). The intervention included recipe modification, environmental changes, and an education program. The outcomes included simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays. A nutrition questionnaire assessed the changes in fruit and vegetable intake at baseline and 3 months following the intervention. The mean SHMI, LQS, and LDS increased in the intervention group (0.51, p < 0.001; 0.27, p = 0.045; 0.95, p < 0.001, respectively) but not in the control group ( p = 0.865; p = 0.339; p = 0.354, respectively). Multivariable linear models demonstrate an increase in the SHMI (β = 0.26, 95% CI [0.12-0.76], p = 0.015), LQS (β = 0.23, 95% CI [0.06-0.83], p = 0.024), and LDS (β = 0.34, 95% CI [0.41-1.39], p < 0.001) of the participants in the intervention group. More participants in the intervention group raised their daily fruit intake compared with the control. We conclude that this integrated intervention program was effective in improving lunch healthy meal index, quality, and diversity in a communal dining room, with a modest halo effect of the intervention throughout the day.",2020,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51, p < 0.001; 0.27, p = 0.045; 0.95, p < 0.001, respectively) but not in the control group (","[""participants' lunch quality and diversity in two communal dining rooms (intervention n = 58 vs. control n = 54""]",['integrated intervention program'],"['simple healthy meal index (SHMI), lunch quality (LQS), and diversity scores (LDS) calculated based on photographs of lunch trays', 'mean SHMI, LQS, and LDS', 'lunch healthy meal index, quality, and diversity', 'daily fruit intake', 'fruit and vegetable intake', 'LQS', 'Healthy Meal Index, Lunch Quality, and Diversity Scores']","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0557648', 'cui_str': 'Dining room'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",,0.0399714,"The mean SHMI, LQS, and LDS increased in the intervention group (0.51, p < 0.001; 0.27, p = 0.045; 0.95, p < 0.001, respectively) but not in the control group (","[{'ForeName': 'Ofira', 'Initials': 'O', 'LastName': 'Katz-Shufan', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Tzahit', 'Initials': 'T', 'LastName': 'Simon-Tuval', 'Affiliation': 'Department of Health Systems Management, Guilford Glazer Faculty of Business and Management and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Sabag', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}, {'ForeName': 'Danit', 'Initials': 'D', 'LastName': 'R Shahar', 'Affiliation': 'The S. Daniel Abraham International Center for Health and Nutrition, Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 8410501, Israel.'}]",Nutrients,['10.3390/nu12061741'] 2948,32532144,Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.,"BACKGROUND Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China. METHOD A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm. RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers' and patients' responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor-patient trust and suboptimal staff motivation. CONCLUSION Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China's rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.",2020,"RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","['9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm', 'Primary Health Care in Rural China', '67 clusters spanning over 3 years in Zhejiang Province, China', ""China's rural primary care facilities""]","['comprehensive intervention', 'Comprehensive Intervention', 'comprehensive CVD risk reduction strategy']","['prescribing behaviour of family doctors and their patient communication skills', 'Risk of Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0934951,"RESULTS Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills.","[{'ForeName': 'Guanyang', 'Initials': 'G', 'LastName': 'Zou', 'Affiliation': 'School of Economics and Management, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of STDs Prevention and Control, Dermatology Hospital, Southern Medical University, Guangzhou 510091, China.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Zhitong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walley', 'Affiliation': 'Nuffield Centre for International Health and Development, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Zhejiang Provincial Centre for Disease Prevention and Control, Hangzhou 310052, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Division of Clinical Epidemiology &Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON M5T 3M7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17114156'] 2949,32532280,Monetary incentives and peer referral in promoting digital network-based secondary distribution of HIV self-testing among men who have sex with men in China: study protocol for a three-arm randomized controlled trial.,"BACKGROUND Human immunodeficiency virus (HIV) testing is a crucial strategy for HIV prevention. HIV testing rates remain low among men who have sex with men (MSM) in China. Digital network-based secondary distribution is considered as an effective model to enhance HIV self-testing (HIVST) among key populations. Digital platforms provide opportunities for testers to apply for HIVST kits by themselves, and secondary distribution allows them to apply for multiple kits to deliver to their sexual partners or members within their social network. We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China. METHODS Three hundred MSM in China will be enrolled through a digital platform for data collection. The eligibility criteria include being biological male, 18 years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up. Eligible participants will be randomly allocated into one of the three arms: standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm. Participants (defined as ""index"") will distribute actual HIV self-test kits to members within their social network (defined as ""alter"") or share referral links to encourage alters to apply HIV self-test kits by themselves. All index participants will be requested to complete a baseline survey and a 3-month follow-up survey. Both indexes and alters will complete a survey upon returning the results by taking a photo of the used kits with the unique identification number. DISCUSSION HIV testing rates remain suboptimal among MSM in China. Innovative interventions are needed to further expand the uptake of HIV testing among key populations. The findings of the trial can provide scientific evidence and experience on promoting secondary distribution of HIVST to reach key populations who have not yet been covered by existing testing services. TRIAL REGISTRATION The study was registered in the Chinese Clinical Trial Registry (ChiCTR1900025433) on 26, August 2019, http://www.chictr.org.cn/showproj.aspx?proj=42001. Prospectively registered.",2020,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China. ","['men who have sex with men (MSM) in China', 'men who have sex with men in China', 'The eligibility criteria include being biological male, 18\u2009years of age or over, ever having had sex with another man, being able to apply for kits via the online platform, and being willing to provide personal telephone number for follow-up', 'Eligible participants']","['standard secondary distribution arm, secondary distribution with monetary incentives arm, and secondary distribution with monetary incentives plus peer referral arm', 'monetary incentives and peer referral']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",[],,0.157662,"We describe a three-arm randomized controlled trial to examine the effect of monetary incentives and peer referral in promoting digital network-based secondary distribution of HIVST among MSM in China. ","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Zhuhai Xutong Voluntary Services Center, Zhuhai, China.'}, {'ForeName': 'Shanzi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Wencan', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Guangquan', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Sha', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Zhuhai Center for Diseases Control and Prevention, Zhuhai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, China. weiming_tang@med.unc.edu.'}]",BMC public health,['10.1186/s12889-020-09048-y'] 2950,32532283,Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial.,"BACKGROUND Individuals affected by heart failure (HF) may present fatigue, dyspnea, respiratory muscle weakness, and sympathetic activity hyperstimulation of the myocardium, among other symptoms. Conducting cardiac rehabilitation (CR) programs can be associated with inspiratory muscle training. The aim of this study was to evaluate the efficacy of inspiratory muscular training (IMT) associated with a CR program on modulating myocardial sympathetic activity and maximal functional capacity, submaximal functional capacity, thickness, and mobility of the diaphragm muscle in patients with HF. METHODS We will conduct a clinical, controlled, randomized, double-blind trial that will include sedentary men and women who are 21-60 years old and who have diagnosed systolic HF and a left ventricular ejection fraction of less than 45%. Participants will be randomly assigned to one of two groups: experimental and control. The control group will follow the conventional CR protocol, and the experimental group will follow the conventional CR protocol associated with IMT 7 days a week. The two proposed exercise protocols will have a frequency of three times a week for a period of 12 weeks. The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol. DISCUSSION This clinical trial will be the first study to investigate the additional effects of IMT on CR in sympathetic hyperstimulation in the myocardium. The results of this study will contribute to developing therapeutic strategies collaborating to elucidate whether the association of IMT with CR can induce clinical benefits for patients with HF. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02600000. Registered November 9, 2015. Retrospectively registered.",2020,"The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol. ","['patients with HF', 'patients with heart failure', 'sedentary men and women who are 21-60\u2009years old and who have diagnosed systolic HF and a left ventricular ejection fraction of less than\u200945']","['CR program', 'Conducting cardiac rehabilitation (CR) programs', 'inspiratory muscular training (IMT', 'inspiratory muscle training', 'cardiac rehabilitation program', 'IMT']","['maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life', 'sympathetic activity and functional capacity', 'myocardial sympathetic activity and maximal functional capacity, submaximal functional capacity, thickness, and mobility of the diaphragm muscle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.102654,"The sympathetic innervation of the cardiac muscle, the maximum and submaximal functional capacity, diaphragm mobility and thickness, and the quality of life of the participants will be evaluated before and after the intervention protocol. ","[{'ForeName': 'Jéssica Costa', 'Initials': 'JC', 'LastName': 'Leite', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Rio Grande do Norte, Av. Senador Salgado Filho, s/n, Natal, 59078-970, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Daniella Cunha', 'Initials': 'DC', 'LastName': 'Brandão', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil. daniellacunha@hotmail.com.'}, {'ForeName': 'Simone Cristina Soares', 'Initials': 'SCS', 'LastName': 'Brandão', 'Affiliation': 'Nuclear Medicine and Cardiology Services, Hospital das Clínicas de Pernambuco, Universidade Federal de Pernambuco, Av. Prof. Moraes Rego, 1235, Recife, 50670-901, Pernambuco, Brazil.'}, {'ForeName': 'Helen Kerlen Bastos', 'Initials': 'HKB', 'LastName': 'Fuzari', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Tainá Maria', 'Initials': 'TM', 'LastName': 'Vidal', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Jasiel', 'Initials': 'J', 'LastName': 'Frutuoso', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Maria Inês', 'Initials': 'MI', 'LastName': 'Remígio', 'Affiliation': 'Department of Clinical Semiology of the Medicine Faculty, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Cidade Universitária, Recife, 50740-560, Pernambuco, Brazil.'}, {'ForeName': 'Bruna Thays Santana', 'Initials': 'BTS', 'LastName': 'de Araújo', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Shirley Lima', 'Initials': 'SL', 'LastName': 'Campos', 'Affiliation': 'Department of Physiotherapy, Universidade Federal de Pernambuco, Av. Jornalista Aníbal Fernandes, s / n, Recife, Pernambuco, 50740-560, Brazil.'}, {'ForeName': 'Armele', 'Initials': 'A', 'LastName': 'Dornelas de Andrade', 'Affiliation': 'Department of Physiotherapy, Universidade Federal do Rio Grande do Norte, Av. Senador Salgado Filho, s/n, Natal, 59078-970, Rio Grande do Norte, Brazil.'}]",Trials,['10.1186/s13063-020-04363-6'] 2951,32532310,"Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.","BACKGROUND Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. METHODS/DESIGN The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75 mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. DISCUSSION Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. TRIAL REGISTRATION ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.",2020,It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks).,"['272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥\u200937\u2009weeks', 'women with mediolateral episiotomy']","['Perineal infiltration (ropivacaine 75\u2009mg or placebo', 'ropivacaine', 'perineal ropivacaine', 'Ropivacaine', 'placebo']","['quality of life', 'analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index', 'perineal pain and mid- and long-term quality of life', 'analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area', 'analgesic efficacy', 'perineal pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",272.0,0.431623,It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks).,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cardaillac', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Ploteau', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Le Thuaut', 'Affiliation': 'Clinical Research Centre, Centre Hospitalier Departemental, 85000, La Roche sur Yon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dochez', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Nantes University Hospital, 44000, Nantes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Ducarme', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, 85000, La Roche sur Yon, France. g.ducarme@gmail.com.'}]",Trials,['10.1186/s13063-020-04423-x'] 2952,32532313,A feasibility study of a WhatsApp-delivered Transtheoretical Model-based intervention to promote healthy eating habits for firefighters in Hong Kong: a cluster randomized controlled trial.,"BACKGROUND Firefighters' health is often affected by a high prevalence of obesity and cardiovascular diseases, which are common risk factors for sudden cardiac death. The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme. METHODS This will be a cluster randomized control trial study. The participants will be assigned randomly into either control (health promotion pamphlet) or intervention (health promotion pamphlet and education materials through WhatsApp) groups. Changes in healthy eating habits will be assessed by a self-administered questionnaire and anthropometric measurements at three different time points. DISCUSSION More education is required in order to improve firefighters' eating habits. TRIAL REGISTRATION ISRCTN registry identifier: Registered on 8 April 2019 ISRCTN95472464.",2020,"The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme. ",['healthy eating habits for firefighters in Hong Kong'],"['WhatsApp-delivered Transtheoretical Model-based intervention', 'control (health promotion pamphlet) or intervention (health promotion pamphlet and education materials through WhatsApp']",['healthy eating habits'],"[{'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.150693,"The aim of this study is to investigate the feasibility of enhancing healthy eating habits in firefighters through an education programme. ","[{'ForeName': 'Wing Man', 'Initials': 'WM', 'LastName': 'Ng', 'Affiliation': 'Division of Science, Engineering and Health Studies, College of Professional and Continuing Education, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. winnie.ng@cpce-polyu.edu.hk.'}, {'ForeName': 'Kin', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",Trials,['10.1186/s13063-020-04258-6'] 2953,32444133,Comparison of two methods for obtaining and transporting corneal samples in suspected infectious keratitis.,"BACKGROUND AND PURPOSE The purpose of this study is to compare two alternative methods of collecting and transporting media for the diagnosis of corneal ulcers, as not all clinical settings have conventional culture materials and transport media available. METHODS In this open-label, prospective, comparative, and randomized study, patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth. The order of each collection method was randomized. The samples were processed by standard methods, comparing the positivity frequencies for both by parametric and nonparametric tests, according to normality criteria. RESULTS Corneal infiltrates from 40 eyes of 40 patients were analyzed. Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258). The overall growth rate of the two methods combined was not higher than with the swab alone. The results obtained with a swab were not influenced by the collection sequence (P=0.112); however, the positivity rate was significantly higher when the sample taken with the needle was performed first (P=0.046). CONCLUSIONS The single sample Eswab method of collection and transportation for the diagnosis of high risk corneal ulcers is a valid alternative and can be used in cases in which, for various reasons, there is no access to the full set of traditional culture materials.",2020,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"['patients with clinical suspicion of infectious keratitis with high risk of loss of vision had corneal specimens collected using two methods and transport media: Eswab scraping with Amies transport medium and 23-gauge needle scraping in BACTEC Peds broth', 'Corneal infiltrates from 40 eyes of 40 patients were analyzed', 'suspected infectious keratitis']",['collecting and transporting media'],"['Culture positivity rate', 'positivity rate', 'overall growth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C3898765', 'cui_str': 'Keratitis caused by infection'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0972753', 'cui_str': 'Transport medium'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C1550050', 'cui_str': 'Amies transport medium'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0853336', 'cui_str': 'Infiltrate of cornea'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C0972753', 'cui_str': 'Transport medium'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",40.0,0.0360887,Culture positivity rate was 50% for Eswab and 35% for 23-gauge needle (P=0.258).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chang-Sotomayor', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: meilinchangsotomayor@gmail.com.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Llorens Bellés', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: llorens.victor@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Latasiewicz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: martuska1111@gmail.com.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torras-Sanvicens', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: JTORRAS@clinic.cat.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Blanco-Domínguez', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: ire_blanco@hotmail.com.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sabater-Cruz', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: noelia.sabater@gmail.com.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sainz-de-la-Maza', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: MSAINZ@clinic.cat.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bosch-Mestres', 'Affiliation': 'Microbiology Department Hospital Clínic de Barcelona, ISGlobal, Carrer de Villarroel, 170, 08036 Barcelona, Spain. Electronic address: JOBOSCH@clinic.cat.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Palma-Carvajal', 'Affiliation': ""Institut Clinic d'Oftalmologia, Carrer de Sabino Arana, 1, 08028 Barcelona, Spain. Electronic address: fpalmac@gmail.com.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2019.10.010'] 2954,32521133,Thrombectomy for Stroke in the Public Health Care System of Brazil.,"BACKGROUND Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries. METHODS We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. RESULTS A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group. CONCLUSIONS In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).",2020,"The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69;","['12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms', '300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period', 'public health system of Brazil', '221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group', 'patients with stroke']","['standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group', 'intravenous alteplase']","['modified Rankin scale', 'modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit', 'score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death', 'Asymptomatic intracranial hemorrhage', 'symptomatic intracranial hemorrhage']","[{'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",300.0,0.164028,"The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69;","[{'ForeName': 'Sheila O', 'Initials': 'SO', 'LastName': 'Martins', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': ""Mont'Alverne"", 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Letícia C', 'Initials': 'LC', 'LastName': 'Rebello', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Abud', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Gisele S', 'Initials': 'GS', 'LastName': 'Silva', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fabrício O', 'Initials': 'FO', 'LastName': 'Lima', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Bruno S M', 'Initials': 'BSM', 'LastName': 'Parente', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Guilherme S', 'Initials': 'GS', 'LastName': 'Nakiri', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Mário B', 'Initials': 'MB', 'LastName': 'Faria', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Michel E', 'Initials': 'ME', 'LastName': 'Frudit', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'João J F', 'Initials': 'JJF', 'LastName': 'de Carvalho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Waihrich', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Fiorot', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fabrício B', 'Initials': 'FB', 'LastName': 'Cardoso', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Raquel C T', 'Initials': 'RCT', 'LastName': 'Hidalgo', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Viviane F', 'Initials': 'VF', 'LastName': 'Zétola', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Carvalho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'de Souza', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Dias', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Bandeira', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Maramélia', 'Initials': 'M', 'LastName': 'Miranda Alves', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Mário B', 'Initials': 'MB', 'LastName': 'Wagner', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Leonardo A', 'Initials': 'LA', 'LastName': 'Carbonera', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Jamary', 'Initials': 'J', 'LastName': 'Oliveira-Filho', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bezerra', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Broderick', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Fogolin Passos', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Octávio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': ""From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2000120'] 2955,32521207,Resistance Training and Milk-Substitution Enhance Body Composition and Bone Health in Adolescent Girls.,"Background: Increased soft-drink consumption has contributed to poor calcium intake with 90% of adolescent girls consuming less than the RDA for calcium. Purpose/objectives: The purpose of this investigation was to determine the independent and additive effects of two interventions (milk and resistance training) on nutrient adequacy, body composition, and bone health in adolescent girls. Methods: The experimental design consisted of four experimental groups of adolescent girls 14-17 years of age: (1) Milk + resistance training [MRT]; n  = 15; (2) Resistance training only [RT]; n  = 15; (3) Milk only [M] n  = 20; (4) Control [C] n  = 16. A few significant differences were observed at baseline between the groups for subject characteristics. Testing was performed pre and post-12 week training period for all groups. Milk was provided (3, 8 oz servings) for both the MRT and the M groups. The MRT group and the RT groups performed a supervised periodized resistance training program consisting of supervised one-hour exercise sessions 3 d/wk (M, W, F) for 12 wk. Baseline dietary data was collected utilizing the NUT-P-FFQ and/or a 120 item FFQ developed by the Fred Hutchinson Cancer Research Center (Seattle, Washington). Body composition was measured in the morning after an overnight fast using dual-energy X-ray absorptiometry (DXA) with a total body scanner (Prodigy TM , Lunar Corporation, Madison, WI). A whole body scan for bone density and lumbar spine scans were performed on all subjects. Maximal strength of the upper and lower body was assessed via a one-repetition maximum (1-RM) squat and bench press exercise protocols. Significance was set at P  ≤ 0.05. Results: Significant differences in nutrient intakes between groups generally reflected the nutrient composition of milk with greater intakes of protein and improved nutrient adequacy for several B vitamins, vitamin A, vitamin D, calcium, magnesium, phosphorus, potassium, and zinc. Mean calcium intake was 758 and 1581 mg/d, in the non-milk and milk groups, respectively, with 100% of girls in the milk groups consuming > RDA of 1300 mg/d. There were no effects of milk on body composition or muscle performance, but resistance training had a main effect and significantly increased body mass, lean body mass, muscle strength, and muscle endurance. There was a main effect of milk and resistance training on several measures of bone mineral density (BMD). Changes in whole body BMD in the M, RT, MRT, and CON were 0.45, 0.52, 1.32, and -0.19%, respectively ( P  < 0.01). Conclusions: Over the course of 12 weeks the effects of 1300 mg/d of calcium in the form of fluid milk combined with a heavy resistance training program resulted in the additive effects of greater nutrient adequacy and BMD in adolescent girls. While further studies are needed, combining increased milk consumption with resistance training appears to optimize bone health in adolescent girls.",2020,"Mean calcium intake was 758 and 1581 mg/d, in the non-milk and milk groups, respectively, with 100% of girls in the milk groups consuming > RDA of 1300 mg/d.","['adolescent girls 14-17\u2009years of age: (1', 'adolescent girls', 'Adolescent Girls']","['heavy resistance training program', 'Milk\u2009+\u2009resistance training [MRT]; n \u2009=\u200915; (2) Resistance training only [RT]; n \u2009=\u200915; (3) Milk only [M] n \u2009=\u200920; (4) Control [C] n \u2009=\u200916', 'resistance training', 'two interventions (milk and resistance training', 'milk and resistance training', 'Resistance Training and Milk-Substitution Enhance Body Composition and Bone Health']","['Mean calcium intake', 'bone density and lumbar spine scans', 'Body composition', 'nutrient composition of milk with greater intakes of protein and improved nutrient adequacy for several B vitamins, vitamin A, vitamin D, calcium, magnesium, phosphorus, potassium, and zinc', 'nutrient adequacy, body composition, and bone health', 'Maximal strength of the upper and lower body', 'bone mineral density (BMD', 'nutrient intakes', 'body mass, lean body mass, muscle strength, and muscle endurance', 'body composition or muscle performance']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",,0.0149534,"Mean calcium intake was 758 and 1581 mg/d, in the non-milk and milk groups, respectively, with 100% of girls in the milk groups consuming > RDA of 1300 mg/d.","[{'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Gómez', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Lee', 'Affiliation': 'Human Performance Laboratory, Department of Kinesiology, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Tunde K', 'Initials': 'TK', 'LastName': 'Szivak', 'Affiliation': 'School of Health Sciences, Merrimack College, North Andover, Massachusetts, USA.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1770636'] 2956,32521250,"Efficacy and safety of TS-121, a novel vasopressin V 1B receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study.","Vasopressin 1B (V 1B ) receptor has a pivotal role in the regulation of the hypothalamus-adrenal-pituitary axis, and V 1B receptor antagonists have shown efficacy in a number of preclinical models of depression. The efficacy and safety of, TS-121 (active ingredient: THY1773), a novel V 1B receptor antagonist, was investigated in patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy. In a randomized, double-blind, placebo-controlled phase 2 study, 51 MDD patients (43 of whom completed the study) were randomly assigned to either TS-121 10 mg, 50 mg or placebo for 6 weeks treatment period. The primary endpoint was change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6. The study was conducted from Jul 2017 to Dec 2018. The changes from baseline in MADRS score at week 6 (Least Square Mean [95% Confidence interval] were: TS-121 10 mg (-9.0 [-13.9, -4.1]), TS-121 50 mg (-9.0 [-13.4, -4.5]), and placebo (-6.4 [-10.7, -2.2]). TS-121 groups showed greater numerical reductions in MADRS score change from baseline compared to placebo, though these reductions did not achieve statistical significance. Similar trends of numerically greater improvements in TS-121 groups were observed across secondary endpoints. Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint. These findings, combined with favorable safety and tolerability, warrant further investigation of TS-121 in an adequately powered study in patients with MDD.",2020,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"['51 MDD patients (43 of whom completed the study', 'patients with MDD', 'patients with major depressive disorder', 'patients with major depressive disorder (MDD) who had an inadequate response to current antidepressant therapy', 'Jul 2017 to Dec 2018']","['TS-121, a novel vasopressin V 1B receptor antagonist', 'Vasopressin 1B (V 1B ) receptor', 'TS-121', 'TS-121 50\xa0mg', 'TS-121 10\xa0mg, 50\xa0mg or placebo', 'placebo']","['MADRS score', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'MADRS score change', 'Higher baseline urinary and hair cortisol levels']","[{'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",51.0,0.556683,Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kamiya', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA. Electronic address: ma-kamiya@taisho.co.jp.'}, {'ForeName': 'Helene D', 'Initials': 'HD', 'LastName': 'Sabia', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marella', 'Affiliation': 'Taisho Pharmaceutical R&D Inc., 350 Mount Kemble Avenue, Morristown, NJ, 07960, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, 55 Fruit Street, Bulfinch 351, Boston, MA, 02114, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': 'University of Texas Dell Medical School in Austin, 1601 Trinity Street, Stop Z0600, Office HDB 4.112, Austin, TX, 78712, USA.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Umeuchi', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}, {'ForeName': 'Michihiko', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Chaki', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Research Headquarters, 1-403 Yoshino-cho, Kita-ku, Saitama, Saitama, 331-9530, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nishino', 'Affiliation': 'Taisho Pharmaceutical Co., Ltd., Development Headquarters, 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.017'] 2957,32532258,CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial.,"BACKGROUND Oral CXC chemokine receptor 2 (CXCR2) antagonists have been shown to inhibit neutrophil migration and activation in the lung in preclinical and human models of neutrophilic airway inflammation. A previous study with danirixin, a reversible CXCR2 antagonist, demonstrated a trend for improved respiratory symptoms and health status in patients with COPD. METHODS This 26-week, randomised, double-blind, placebo-controlled phase IIb study enrolled symptomatic patients with mild-to-moderate COPD at risk for exacerbations. Patients received danirixin 5, 10, 25, 35 or 50 mg twice daily or placebo in addition to standard of care. Primary end-points were the dose response of danirixin compared with placebo on the incidence and severity of respiratory symptoms (Evaluating Respiratory Symptoms in COPD [E-RS:COPD] scores) and safety. Secondary end-points included the incidence of moderate-severe exacerbations, health status (COPD Assessment test, CAT) and health-related quality of life HRQoL (St. George Respiratory Questionnaire-COPD, SGRQ-C). RESULTS A total of 614 participants were randomized to treatment. There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed. There was an increased incidence of exacerbation in the danirixin-treated groups and an increased number of pneumonias in participants treated with danirixin 50 mg. CONCLUSIONS The robust placebo and study effects prohibited any conclusions on the efficacy of danirixin. However, the absence of a clear efficacy benefit and the observed increase in exacerbations in danirixin-treated groups suggests an unfavorable benefit-risk profile in patients with COPD. TRIAL REGISTRATION This study was registered with clinicaltrials.gov, NCT03034967.",2020,"There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed.","['614 participants', 'controlled phase IIb study enrolled symptomatic patients with mild-to-moderate COPD at risk for exacerbations', 'patients with COPD', 'patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion']","['danirixin', 'CXCR2 antagonist', 'placebo']","['number of pneumonias', 'respiratory symptoms and health status', 'dose response of danirixin', 'exacerbations', 'E-RS:COPD, CAT or SGRQ-C scores', 'incidence of exacerbation', 'incidence of moderate-severe exacerbations, health status (COPD Assessment test, CAT) and health-related quality of life HRQoL (St. George Respiratory Questionnaire-COPD, SGRQ-C', 'incidence and severity of respiratory symptoms (Evaluating Respiratory Symptoms in COPD [E-RS:COPD] scores) and safety']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}]","[{'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0527994', 'cui_str': 'Interleukin-8B Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",614.0,0.583333,"There were no improvements in E-RS:COPD, CAT or SGRQ-C scores in participants treated with any dose of danirixin compared to placebo; a larger than expected placebo effect was observed.","[{'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': 'GSK, Collegeville, PA, USA. aili.l.lazaar@gsk.com.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Miller', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Donald', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keeley', 'Affiliation': 'GSK - Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ambery', 'Affiliation': 'GSK - Stockley Park, Uxbridge, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL) -, Grosshansdorf, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GSK, Collegeville, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory research,['10.1186/s12931-020-01401-4'] 2958,32532262,High flow nasal therapy during early pulmonary rehabilitation in patients with acute severe exacerbation of COPD: beneficial or illusory?,"In study ""Effect of high-flow nasal therapy during early pulmonary rehabilitation in patients with severe AECOPD: a randomized controlled study"" by Tung et al., authors concluded HFNT utilization led to enhanced exercise tolerance and a reduction of systemic inflammation. Nevertheless, some points requires additional discussion, the conclusion of the trial seems overstated. The baseline differences between groups induces substantial modifications in the conclusions of this trial. HFNT does not seem to add any benefit on exercise tolerance or systemic inflammation, nor on pulmonary function. The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.",2020,The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.,"['patients with severe AECOPD', 'patients with acute severe exacerbation of COPD']","['High flow nasal therapy', 'HFNT', 'high-flow nasal therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.06232,The only difference that remained significant in homogenous statistical significance is dyspnea on the mMRC scale but clinical significance is highly questionable.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, 1200, Brussels, Belgium. gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, Groupe de Recherche en Kinésithérapie Respiratoire, Université Catholique de Louvain, 1200, Brussels, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Institute for Research and Innovation in Biomedicine (IRIB), Normandie Univ, UNIROUEN, EA3830-GRHV, 76000, Rouen, France.'}]",Respiratory research,['10.1186/s12931-020-01415-y'] 2959,32532267,Efficacy of nano-carbonate apatite dentifrice in relief from dentine hypersensitivity following non-surgical periodontal therapy: a randomized controlled trial.,"BACKGROUND Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. METHODS 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. RESULTS 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256). CONCLUSIONS Home-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. TRIAL REGISTRATION Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017).",2020,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"['48 periodontitis patients with DH', '45 participants completed the follow-up', 'dentine hypersensitivity following non-surgical periodontal therapy']","['nano-carbonate apatite dentifrice', 'dentifrice containing nano-carbonate apatite (n-CAP']","['DH', 'dentine hypersensitivity (DH', 'alleviation of DH', 'relief from hypersensitivity', 'change of VAS', 'Periodontal parameters', 'visual analogue scale (VAS) and Schiff sensitivity scale', 'change of Schiff']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0054675', 'cui_str': 'Carbapatite'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",48.0,0.0479244,Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score.,"[{'ForeName': 'Pei-Hui', 'Initials': 'PH', 'LastName': 'Ding', 'Affiliation': 'Department of Periodontology, Affiliated Hospital of Stomatology, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Hua-Jiao', 'Initials': 'HJ', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Ping', 'Initials': 'JP', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Jia-Mei', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Zhejiang University School of Stomatology, Hangzhou, China. chenlili_1030@zju.edu.cn.'}]",BMC oral health,['10.1186/s12903-020-01157-9'] 2960,32532275,"A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids.","BACKGROUND Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist. METHODS This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV 1 ) and clinic FEV 1 3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV 1 , evening FEV 1 , morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study. RESULTS The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo. No new safety signals were identified. CONCLUSIONS UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg). TRIAL REGISTRATION GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.",2020,"UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo.","['patients with asthma receiving inhaled corticosteroids', 'Patients with asthma uncontrolled on inhaled', 'subjects with fully reversible, uncontrolled/partially-controlled moderate asthma', 'patients with reversible, uncontrolled/partially-controlled asthma for ≥6\u2009months, receiving ≥100 mcg/day', 'or equivalent) for ≥12\u2009weeks']","['UMEC 62.5 mcg: n =139, placebo', 'UMEC', 'fluticasone propionate', 'corticosteroids', 'UMEC 31.25 mcg, UMEC 62.5 mcg or placebo', 'open-label fluticasone furoate (FF', 'placebo']","['Safety', 'clinic trough forced expiratory volume in 1\u2009s (FEV 1 ) and clinic FEV 1 3\u2009h post-dose', 'clinic FEV', 'clinic trough FEV', 'lung function', 'home daily spirometry (trough FEV 1 , evening FEV 1 , morning [pre-dose] and evening peak expiratory flow', 'efficacy, safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3853135', 'cui_str': 'Somewhat controlled'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4517704', 'cui_str': '31.25'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.607591,"UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV 1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV 1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Crisor LLC Research, Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Zelie', 'Initials': 'Z', 'LastName': 'Bailes', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Asthma & Allergy Associates, P.C. and Research Center, Colorado Springs, CO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Dahl', 'Affiliation': 'GSK, 980 Great West Road, Brentford, Middlesex, UK.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'von Maltzahn', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Robbins', 'Affiliation': 'GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'GSK, Upper Providence, PA, USA. laurie.myers.lee@gmail.com.'}]",Respiratory research,['10.1186/s12931-020-01400-5'] 2961,32532766,Effect of different communication strategies about stopping cancer screening on screening intention and cancer anxiety: a randomised online trial of older adults in Australia.,"OBJECTIVE To assess different strategies for communicating to older adults about stopping cancer screening. DESIGN 4 (recommendation statement about stopping screening)×(2; time) online survey-based randomised controlled trial. SETTING Australia. PARTICIPANTS 271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade. INTERVENTIONS Time 1: participants read a scenario in which their general practitioner (GP) informed them about the potential benefits and harms of cancer screening, followed by double-blinded randomisation to one of four recommendation statements to stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively ('this test would not help you live longer') and negatively ('you may not live long enough to benefit'). Time 2: in a follow-up scenario, the GP explained why guidelines changed over time (anchoring bias intervention). MEASURES Primary outcomes: screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety), measured at both time points. SECONDARY OUTCOMES trust (in their GP, the information provided, the Australian healthcare system), decisional conflict and knowledge of the information presented. RESULTS 271 participants' responses analysed. No main effects were found. However, screening intention was lower for the negatively framed life expectancy versus health status statement (6.0 vs 7.1, mean difference (MD)=1.1, p=0.049, 95% CI 0.0 to 2.2) in post hoc analyses. Cancer anxiety was lower for the negatively versus positively framed life expectancy statement (4.8 vs 5.8, MD=1.0, p=0.025, 95% CI 0.1 to 1.9). The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions. CONCLUSION Older adults may reduce their screening intention without reporting increased cancer anxiety when clinicians use a more confronting strategy communicating they may not live long enough to benefit and add an explicit explanation why the recommendation has changed. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12618001306202; Results).",2020,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions. ","['Australia', '271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade', ""271 participants' responses analysed"", 'Older adults', 'older adults in Australia']","['communication strategies about stopping cancer screening', ""stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively""]","['Australian healthcare system), decisional conflict and knowledge of the information presented', 'screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety', 'screening intention and cancer anxiety', 'screening intention', 'Cancer anxiety', 'cancer anxiety']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",271.0,0.458737,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions. ","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael H', 'Initials': 'RH', 'LastName': 'Dodd', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Hersch', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia jesse.jansen@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034061'] 2962,32532767,Does accreditation of general practice promote patient-reported quality of care? A natural cluster randomised experiment.,"OBJECTIVE To investigate whether accreditation of general practice in Denmark promotes patient-reported quality of care and patient satisfaction. DESIGN A national cluster randomised case control study based on an online version of the Danish Patients Evaluate Practice questionnaire. Mixed effects ordered logit regression models taking account of clustering of patients in different municipalities were used in the analyses. SETTING General practice in Denmark. PARTICIPANTS A representative sample of the Danish population. PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcome measure was patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures. RESULTS In total, 3609 respondents answered the survey. We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04). However, there was a statistically significant negative relationship between patient satisfaction with the general practice and recent practice accreditation compared with satisfaction with practices not yet accredited (OR=0.81, 95% CI 0.67 to 0.97) but no significant relationship between patient satisfaction with the general practice and previous accreditation (OR=0.91, 95% CI 0.76 to 1.09). CONCLUSION Accreditation does not promote patient-reported quality of care or patient satisfaction. On the contrary, patient satisfaction with the general practice decreases when general practice is recently accredited.",2020,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","['A representative sample of the Danish population', 'General practice in Denmark', '3609 respondents answered the survey']",[],"['quality of care and practice accreditation', 'patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",3609.0,0.158256,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Riisgaard', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark hriisgaard@health.sdu.dk.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Kirstine Andersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034465'] 2963,32532781,Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study.,"INTRODUCTION Data supports that motor skills are an underlying mechanism that influence physical activity along with perceived motor and physical competence, but the relationship between motor skills and physical activity during the early years is unclear. The goal of this study, Promoting Activity and Trajectories of Health (PATH) for Children, is to examine and compare the immediate (pre-test to post-test) and sustained (3-year follow-up) effect of an intervention on motor performance, physical activity and perceived physical competence to a control condition (ie, standard practice) in preschool-age children. METHODS AND ANALYSIS The PATH study is a two-cohort, randomised cluster clinical trial. 300 children between the ages of > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition. Each assessment involves a measure of motor skill performance; product and process, seven consecutive days of physical activity monitoring and perceived physical competence. These measures will be assessed before and after the intervention (pre-test to post-test) and then each academic year across 3 years, grades kindergarten, first grade and second grade (3-year follow-up). To assess the clustered longitudinal effect of the intervention on outcome measures, random-effects models (eg, mixed model regression, growth curve modelling and structural equation modelling) will be used. The PATH study addresses gaps in paediatric exercise science research. Findings hold the potential to help shape public health and educational policies and interventions that support healthy development and active living during the early years. ETHICS AND DISSEMINATION Ethical approval for this study was obtained through the Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan (HUM00133319). The PATH study is funded by the National Institutes of Health. Findings will be disseminated via print, online media, dissemination events and practitioner and/or research journals. TRIAL REGISTRATION NUMBER NHLBI ClinicalTrials.gov Identifier, NCT03189862. Registered 17 August 2017, https://clinicaltrials.gov/ct2/show/NCT03189862.",2020,300 children between the ages of > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"['Registered 17 August 2017', 'n=153) or control (n=147) condition', 'preschool-age children', '300 children between the ages of > 3.5 to 5 years of age']","['motor skills intervention', 'motor skill intervention']","['motor performance, physical activity and perceived physical competence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",300.0,0.0865729,300 children between the ages of > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"[{'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA lerobin@umich.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'Department of Physical Education, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Ulrich', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037497'] 2964,32532790,A 3-Arm Randomized Phase II Study of Bendamustine/Rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408.,"PURPOSE We sought to improve upon frontline bendamustine/rituximab (BR) induction therapy followed by rituximab maintenance in untreated high-risk follicular lymphoma (FL). PATIENTS AND METHODS Patients were randomized to BR induction followed by 2-year rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR). Dual primary objectives were complete remission (CR) rate and 1-year disease-free survival (DFS); 289 patients enrolled (NCT01332968). RESULTS For induction, 92%, 87%, and 86% of patients randomized to BR-R , BVR-R , or BR-LR received 6 cycles, respectively. CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04). One-year DFS rates with BR-R vs. BR-LR were 85% vs. 67%, respectively ( P =0.0009). This was due to an imbalance in CR rates post-BR induction and discontinuation due to adverse events (AEs). The most common grade 3-4 AEs for BVR vs. BR were neutropenia and sensory neuropathy (12% vs. <1%); 83% of the latter with intravenous bortezomib. The most common grade 3-4 AEs related to LR vs. rituximab maintenance were neutropenia 66% vs. 21% ( P <0.0001) and febrile neutropenia 10% vs. 2% ( P =0.05). The overall treatment-related mortality was 1.4%. With 5-year median follow-up, 3-year PFS rates for BR-R, BVR-R, and BR-LR were 77%, 82%, and 76%, respectively ( P =0.36) with OS rates of 87%, 90%, and 84%, respectively ( P =0.79). For prognostication, CR rate and POD-24 were associated with survival. CONCLUSIONS Altogether, neither bortezomib added to BR induction nor lenalidomide added to rituximab maintenance immediately post-BR induction are recommended in untreated FL.",2020,CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04).,"['Untreated Follicular Lymphoma', 'untreated high-risk follicular lymphoma (FL', 'Patients']","['bortezomib', 'Bendamustine/Rituximab with Bortezomib', 'bendamustine/rituximab (BR) induction therapy', 'rituximab maintenance (BR-R), BR with bortezomib and rituximab maintenance (BVR-R), or BR followed by lenalidomide (1 year) with rituximab maintenance (BR-LR']","['OS rates', 'febrile neutropenia', 'CR rate and POD-24', 'overall treatment-related mortality', 'neutropenia and sensory neuropathy', 'CR rate with BR vs. BVR induction', '3-year PFS rates for BR-R, BVR-R, and BR-LR', 'complete remission (CR) rate and 1-year disease-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",289.0,0.0918214,CR rate with BR vs. BVR induction was 62% vs. 75% ( P =0.04).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Evens', 'Affiliation': 'Division of Blood Disorders, Rutgers Cancer Institute of New Jersey ae378@cinj.rutgers.edu.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Dana Farber Cancer Institutes.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Medicine, College of Medicine, Mayo Clinic.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Internal Medicine, Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Quon', 'Affiliation': 'Radiology, Stanford University School of Medicine.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Pathology and Laboratory Medicine, University of Wisconsin School of Medicine.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic.'}, {'ForeName': 'Puneet Singh', 'Initials': 'PS', 'LastName': 'Cheema', 'Affiliation': ""Saint John's Hospital Health East Care System.""}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Dy', 'Affiliation': 'Decatur Memorial Hospital.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'medicine, University Hospitals Seidman Cancer Center.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University.'}, {'ForeName': 'Terrence P', 'Initials': 'TP', 'LastName': 'Cescon', 'Affiliation': 'McGlinn Cancer Institute, Tower Health.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Dept of Medicine, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Washington University in St. Louis School of Medicine.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1345'] 2965,32533228,Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).,"PURPOSE To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer. METHODS This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H 0 ), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H 0 was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated early after 74 patients; 68 patients were evaluable. RESULTS Two-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H 0 was rejected. Median OS was 49.1 vs. 24.1 months (p = 0.147). Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21). At 2 years, PFS was 56% vs. 44%, LC 84% vs. 72%, and MFS 74% vs. 54%. HRs were 0.51 (0.25-1.04) for progression, 0.43 (0.13-1.40) for locoregional failure, and 0.43 (0.17-1.05) for distant metastasis. Overall response was 81% vs. 69% (p = 0.262). Twenty-six and 27 patients, respectively, experienced at least one toxicity grade ≥3 (p = 0.573). A significant difference was found for grade ≥3 allergic reactions (12.5% vs. 0%, p = 0.044). CONCLUSION Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.",2020,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"['74\xa0patients; 68\xa0patients were evaluable', 'unresectable esophageal cancer']","['cetuximab', 'radiochemotherapy', 'radiochemotherapy plus cetuximab', 'Radiochemotherapy with or without cetuximab']","['PFS', 'Median OS', 'efficacy and toxicity', 'PFS and MFS', 'locoregional failure', 'progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity', '2‑year overall survival (OS', 'Overall response', 'grade ≥3 allergic reactions', 'Hazard ratio (HR) for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.261344,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rades', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee\xa0160, 23562, Lübeck, Germany. Rades.Dirk@gmx.net.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bartscht', 'Affiliation': 'Department of Hematology and Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hunold', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiation Oncology, Johannes-Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Belka', 'Affiliation': 'Department of Radiation Oncology, Ludwig-Maximillians University, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Homann', 'Affiliation': 'Medical Department II, Klinikum Wolfsburg, Wolfsburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Spillner', 'Affiliation': 'Department of Radiation Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Petersen', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Ridwelski', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Karcher-Kilian', 'Affiliation': 'Practice for Gastroenterology, Diabetology, Oncology and Hematology Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kranich', 'Affiliation': 'Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Männikkö', 'Affiliation': 'Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Scottsdale, AZ, USA.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Maderer', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01646-4'] 2966,31812681,Effect of two different dietary fatty acid profiles and variant rs266729 in ADIPOQ on weight loss and adiponectin concentrations.,"BACKGROUND The role of ADIPOQ gene rs266729 variants on weight loss after a dietary intervention are still unclear. OBJECTIVE To analyze the effects of the ADIPOQ gene rs266729 variant n weight loss, cardiovascular risk factors, and adiponectin levels after two hypocaloric diets with different dietary fatty profiles. DESIGN A population of 362 obese patients was enrolled in a randomized clinical trial with two diets (Diet M, monounsaturated fat-enriched diet, and Diet P, polyunsaturated-fat enriched diet). Anthropometric measurements, an assessment of nutritional intake, and biochemical tests were performed at baseline and after 12 weeks. RESULTS Weight loss was similar with both diets. After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/dL, p=0.01), and insulin levels (-2.6±1.0mU/L vs. -0.7±0.3mU/L, p=0.02) and in HOMA-IR (-0.5±0.2 units vs. -0.2±0.4 units, p=0.03). The same improvement was reported after Diet P in all parameters, including total cholesterol (CC vs. CG±GG) (-8.0±1.2mU/L vs. -2.1±1.4mg/dL, p=0.02), LDL cholesterol (-7.3±1.2mg/dL vs. -2.1±0.8mg/dL, p=0.02), glucose (-3.2±0.1mg/dL vs. -0.2±0.5mg/dL, p=0.01), and insulin levels (-2.5±1.0mU/L vs. -1±0.6mU/L, p=0.02) and HOMA-IR (-0.5±0.1 units vs. -0.3±0.4 units, p=0.02). Only subjects with CC genotype showed significant increases in adiponectin levels after both diets: (Diet M: 10.3±2.0ng/dL vs. Diet P: 9.3±2.9ng/dL, p=0.43). CONCLUSION The CC genotype of ADIPOQ gene rs266729 variant is associated to increased adiponectin levels and decreases in LDL cholesterol, glucose, insulin, and HOMA-IR levels after weight loss.",2020,"After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/",['A population of 362 obese patients'],"['diets (Diet M, monounsaturated fat-enriched diet, and Diet P, polyunsaturated-fat enriched diet']","['Weight loss', 'HOMA-IR', 'weight loss, cardiovascular risk factors, and adiponectin levels', 'LDL cholesterol', 'total cholesterol (CC vs. CG±GG', 'weight loss', 'LDL cholesterol, glucose, insulin, and HOMA-IR levels', 'adiponectin levels', 'weight loss and adiponectin concentrations', 'insulin levels']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",362.0,0.0210599,"After Diet M, only subjects with CC genotype showed significant improvements in total cholesterol (CC vs. CG±GG) (-9.0±1.1mU/L vs. -4.5±2.4mg/dL, p=0.01), LDL cholesterol (-6.0±1.1mg/dL vs. -3.0±0.9mg/dL, p=0.03), glucose (-4.7±1.1mg/dL vs. -0.6±0.5mg/","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: dadluis@yahoo.es.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.09.004'] 2967,31830292,Neuroprotective Effect of Citicoline Eye Drops on Corneal Sensitivity After LASIK.,"PURPOSE To evaluate the accelerator role of a topically administered neuroprotective eye drop (citicoline) on the recovery of corneal sensitivity after laser in situ keratomileusis (LASIK). METHODS In this prospective, controlled study, 78 eyes of 78 patients (mean age: 26.8 ± 7.6 years) were enrolled in the study group and their eyes were treated with topical citicoline three times a day for 1 month postoperatively. Seventy-eight eyes of 78 patients (mean age: 26.1 ± 7.4 years) were randomly selected as the control group and their eyes were treated with lubricant hyaluronic acid (0.15%) eye drops three times a day for 1 month. Corneal sensitivity was assessed in both groups using a Cochet-Bonnet esthesiometer at baseline and 1, 2, 3, 4, 6, 8, and 12 weeks after the LASIK procedure. RESULTS Corneal sensitivity at 1, 2, 3, 4, and 6 weeks after LASIK was significantly better in the citicoline group than the control group (P < .05 for all). Differences between the groups at 8 and 12 weeks after LASIK were not significant (P > .05). CONCLUSIONS Topically administered citicoline eye drops had beneficial effects in the early recovery of corneal sensitivity during the first 6 weeks after LASIK, suggesting that citicoline may play a significant role in accelerating corneal reinnervation. [J Refract Surg. 2019;35(12):764-770.].",2019,"Differences between the groups at 8 and 12 weeks after LASIK were not significant (P > .05). ","['78 eyes of 78 patients (mean age: 26.8 ± 7.6 years', 'Seventy-eight eyes of 78 patients (mean age: 26.1 ± 7.4 years']","['lubricant hyaluronic acid', 'citicoline', 'neuroprotective eye drop (citicoline', 'Citicoline Eye Drops', 'topical citicoline']","['Corneal sensitivity', 'accelerating corneal reinnervation', 'corneal sensitivity', 'Corneal Sensitivity']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C4517858', 'cui_str': '7.4'}]","[{'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation'}]",,0.020994,"Differences between the groups at 8 and 12 weeks after LASIK were not significant (P > .05). ","[{'ForeName': 'Esat', 'Initials': 'E', 'LastName': 'Cinar', 'Affiliation': ''}, {'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Yuce', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Aslan', 'Affiliation': ''}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Erbakan', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20191021-01'] 2968,31830294,Refractive and Visual Outcomes and Rotational Stability of Toric Intraocular Lenses in Eyes With and Without Previous Ocular Surgeries: A Longitudinal Study.,"PURPOSE To evaluate visual and refractive outcomes and rotational stability of toric intraocular lens (IOL) implantation in eyes with previous ocular surgeries. METHODS This controlled, longitudinal cohort study included a total of 133 eyes (59 study cases with a history of corneal, vitreoretinal, and/or glaucoma surgery and 74 randomly selected controls without a history of ocular surgery) that had cataract and corneal astigmatism treated with toric IOL implantation. Postoperative outcomes were recorded at postoperative 1 month and 3 to 12 months. RESULTS Refractive prediction errors were within ±1.00 diopter (D) of target in 93.5% and 88.4% of the study cases at postoperative 1 month and 3 to 12 months, respectively. They were within ±0.50 D of target in 56.5% and 60.5% of the cases during the same follow-up intervals, respectively. Study cases showed statistically significantly inferior uncorrected distance visual acuity (UDVA) compared to controls at 1 month postoperatively (0.27 ± 0.24 and 0.17 ± 0.21 logMAR, respectively, P = .027) but not during the later follow-up (0.19 ± 0.19 and 0.16 ± 0.19 logMAR, respectively, P = .431). Corrected distance visual acuity (CDVA) was slightly lower in the study cases than in controls at 1 month postoperatively (0.13 ± 0.16 and 0.07 ± 0.14, respectively, P = .005) and subsequent follow-up months (0.10 ± 0.13 and 0.03 ± 0.10, respectively, P < .001). Of the examined study cases, 93.9% and 88.4% had IOL axes within 5° of intended axis at postoperative 1 month and 3 to 12 months, respectively. CONCLUSIONS Toric IOLs provided significant and sustained improvement in visual acuity and refraction in eyes with a history of prior ophthalmic surgery. Refractive outcomes achieved postoperatively were comparable to those in eyes without a prior history of ophthalmic surgery, although the rate of visual recovery may be different. [J Refract Surg. 2019;35(12):781-788.].",2019,"Refractive outcomes achieved postoperatively were comparable to those in eyes without a prior history of ophthalmic surgery, although the rate of visual recovery may be different.","['eyes with previous ocular surgeries', 'With and Without Previous Ocular Surgeries', 'Eyes', 'longitudinal cohort study included a total of 133 eyes (59 study cases with a history of corneal, vitreoretinal, and/or glaucoma surgery and 74 randomly selected controls without a history of ocular surgery) that had cataract and corneal astigmatism treated with toric IOL implantation']","['Toric Intraocular Lenses', 'toric intraocular lens (IOL) implantation']","['rate of visual recovery', 'inferior uncorrected distance visual acuity (UDVA', 'Refractive and Visual Outcomes and Rotational Stability', 'Corrected distance visual acuity (CDVA', 'visual acuity and refraction', 'IOL axes', 'Postoperative outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0445083,"Refractive outcomes achieved postoperatively were comparable to those in eyes without a prior history of ophthalmic surgery, although the rate of visual recovery may be different.","[{'ForeName': 'Osama M', 'Initials': 'OM', 'LastName': 'Mustafa', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Prescott', 'Affiliation': ''}, {'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Alsaleh', 'Affiliation': ''}, {'ForeName': 'Daliya', 'Initials': 'D', 'LastName': 'Dzhaber', 'Affiliation': ''}, {'ForeName': 'Yassine J', 'Initials': 'YJ', 'LastName': 'Daoud', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20191021-03'] 2969,32534080,Photographic assessment of post-surgical facial scars epidermally sutured with rapidly-absorbable polyglactin 910 or nylon: A randomized clinical trial.,"BACKGROUND Surgeons use absorbable and non-absorbable sutures for epidermal wound closure. No large, randomized studies have compared the effect of these suture types on facial scar appearance. OBJECTIVE To assess post-surgical facial scar appearance using either rapidly-absorbable polyglactin 910 or nylon for epidermal closure. METHODS Randomized, blinded, split-scar clinical trial. 105 patients with facial wounds resulting from MMS excisions were randomized for epidermal closure using rapidly-absorbable 5-0 polyglactin 910 (Vicryl Rapide™) on one half of the repair, and 5-0 nylon (Ethilon™) on the other half. Two physicians (one dermatologist, one plastic surgeon), unaware of original suture location, examined photographs of each healed wound at six-months postoperative and graded the appearance of each half of the scar using the visual analog scale (VAS), wound evaluation scale (WES), and Stony Brook scar evaluation scale (SBSES). RESULTS At six-months there was no significant difference in the combined mean (SD) VAS scores [83.1(14.2) and 83.0(13.7)], SBSES scores [4.3(0.9) and 4.4(0.9)], WES scores [5.3(1.1) and 5.2(1.1)] for rapidly-absorbable polyglactin 910 vs nylon (P= .72, .57, .21 respectively). LIMITATIONS Single institution CONCLUSIONS: Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.",2020,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,['105 patients with facial wounds resulting from MMS excisions'],"['rapidly-absorbable polyglactin 910 or nylon', 'absorbable and non-absorbable sutures', 'epidermal closure using rapidly-absorbable 5-0 polyglactin 910 (Vicryl Rapide™) on one half of the repair, and 5-0 nylon (Ethilon™) on the other half', 'Photographic assessment of post-surgical facial scars epidermally sutured with rapidly-absorbable polyglactin 910 or nylon']","['equivalent photographic appearance of facial scars', 'visual analog scale (VAS), wound evaluation scale (WES), and Stony Brook scar evaluation scale (SBSES', 'WES scores', 'combined mean (SD) VAS scores', 'facial scar appearance']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205863', 'cui_str': 'Ethilon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",105.0,0.110754,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,"[{'ForeName': 'Benvon', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': ""Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada; Division of Dermatology, Queen's University, Kingston, Ontario, Canada. Electronic address: benvon.moran@queensu.ca.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Seal', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berkowitz', 'Affiliation': 'Sauder School of Business, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.016'] 2970,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro. AIM OF THE STUDY The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients. METHODS This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients. RESULTS A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed. CONCLUSIONS GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: zhigangliu729@126.com.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053'] 2971,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. HYPOTHESIS A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes. CONCLUSION AND IMPLICATIONS A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. ",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. ","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851'] 2972,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy. METHODS We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM. RESULTS LS-BMD did not change significantly at year 3 (-1.2 ± 1.1%, p = 1.00) compared to year 2 and compared to baseline (-1.75 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years. CONCLUSIONS A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478'] 2973,32445190,"The pharmacokinetics, efficacy, and safety of a novel selective-dose cannabis inhaler in patients with chronic pain: A randomized, double-blinded, placebo-controlled trial.","BACKGROUND Precise cannabis treatment dosing remains a major challenge, leading to physicians' reluctance to prescribe medical cannabis. OBJECTIVE To test the pharmacokinetics, analgesic effect, cognitive performance and safety effects of an innovative medical device that enables the delivery of inhaled therapeutic doses of Δ 9 -Tetrahydrocannabinol (THC) in patients with chronic pain. METHODS In a randomized, three-arms, double-blinded, placebo-controlled, cross-over trial, 27 patients received a single inhalation of Δ 9 -THC: 0.5mg, 1mg, or a placebo. Δ 9 -THC plasma levels were measured at baseline and up to 150-min post-inhalation. Pain intensity and safety parameters were recorded on a 10-cm visual analogue scale (VAS) at pre-defined time points. The cognitive performance was evaluated using the selective sub-tests of the Cambridge Neuropsychological Test Automated Battery (CANTAB). RESULTS Following inhalation of 0.5 mg or 1mg, Δ 9 -THC plasma C max  ± SD were 14.3 ± 7.7 and 33.8 ± 25.7 ng/ml. T max  ± SD were 3.7 ± 1.4 and 4.4 ± 2.1 min, and AUC 0  →  infinity ±SD were 300 ± 144 and 769 ± 331 ng*min/ml, respectively. Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-min. The 1-mg dose showed a significant pain decrease compared to the placebo. Adverse events were mostly mild and resolved spontaneously. There was no evidence of consistent impairments in cognitive performance. CONCLUSION This feasibility trial demonstrated that a metered-dose cannabis inhaler delivered precise and low THC doses, produced a dose-dependent and safe analgesic effect in patients with neuropathic pain/ complex-regional pain syndrome (CRPS). Thus, it enables individualization of medical cannabis regimens that can be evaluated pharmacokinetically and pharmacodynamically by accepted pharmaceutical models. SIGNIFICANCE Evidence suggests that cannabis-based medicines are an effective treatment for chronic pain in adults. The pharmacokinetics of THC varies as a function of its route of administration. Pulmonary assimilation of inhaled THC causes rapid onset of analgesia. However, currently used routes of cannabinoids delivery provide unknown doses, making it impossible to implement a pharmaceutical standard treatment plan. A novel selective-dose cannabis inhaler delivers significantly low and precise doses of THC, thus allowing the administration of inhaled cannabis-based medicines according to high pharmaceutical standards. These low doses of THC can produce safe and effective analgesia in patients with chronic pain.",2020,"Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes.","['Patients with Chronic Pain', '27 patients received a', 'patients with chronic pain', 'patients with neuropathic pain/ complex-regional pain syndrome (CRPS']","['THC', 'Placebo', 'single inhalation of Δ 9 -THC', 'Novel Selective-Dose Cannabis Inhaler', 'Tetrahydrocannabinol', 'placebo']","['pharmacokinetics, analgesic effect, cognitive performance, and safety effects', 'T max ±SD', 'cognitive performance', 'Pharmacokinetics, Efficacy, and Safety', 'Adverse events', 'pain intensity', 'THC plasma levels', 'Pain intensity and safety parameters', 'pain decrease', 'Cognitive performance', '10-cm visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",27.0,0.690991,"Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150-minutes.","[{'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Almog', 'Affiliation': 'Department of Physiology & Pharmacology, Sackler School of Medicine, Tel-Aviv University, and Institute of Pharmacology & Toxicology, Chaim Sheba Medical Center, Tel-Hashomer, Israel.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Aharon-Peretz', 'Affiliation': 'Neuropsychology Unit, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Vulfsons', 'Affiliation': 'Faculty of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Ogintz', 'Affiliation': 'Institute of Pain Medicine, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Abalia', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Lupo', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Hayon', 'Affiliation': 'Syqe Medical LTD, Tel-Aviv, Israel.'}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Faculty of Medicine, Technion, Haifa, Israel.'}]","European journal of pain (London, England)",['10.1002/ejp.1605'] 2974,32442148,Patient Perception of Plain-Language Medical Notes Generated Using Artificial Intelligence Software: Pilot Mixed-Methods Study.,"BACKGROUND Clinicians' time with patients has become increasingly limited due to regulatory burden, documentation and billing, administrative responsibilities, and market forces. These factors limit clinicians' time to deliver thorough explanations to patients. OpenNotes began as a research initiative exploring the ability of sharing medical notes with patients to help patients understand their health care. Providing patients access to their medical notes has been shown to have many benefits, including improved patient satisfaction and clinical outcomes. OpenNotes has since evolved into a national movement that helps clinicians share notes with patients. However, a significant barrier to the widespread adoption of OpenNotes has been clinicians' concerns that OpenNotes may cost additional time to correct patient confusion over medical language. Recent advances in artificial intelligence (AI) technology may help resolve this concern by converting medical notes to plain language with minimal time required of clinicians. OBJECTIVE This pilot study assesses patient comprehension and perceived benefits, concerns, and insights regarding an AI-simplified note through comprehension questions and guided interview. METHODS Synthea, a synthetic patient generator, was used to generate a standardized medical-language patient note which was then simplified using AI software. A multiple-choice comprehension assessment questionnaire was drafted with physician input. Study participants were recruited from inpatients at the University of Colorado Hospital. Participants were randomly assigned to be tested for their comprehension of the standardized medical-language version or AI-generated plain-language version of the patient note. Following this, participants reviewed the opposite version of the note and participated in a guided interview. A Student t test was performed to assess for differences in comprehension assessment scores between plain-language and medical-language note groups. Multivariate modeling was performed to assess the impact of demographic variables on comprehension. Interview responses were thematically analyzed. RESULTS Twenty patients agreed to participate. The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant. Age, ethnicity, and health literacy were found to have a significant impact on comprehension scores by multivariate modeling. Thematic analysis of guided interviews highlighted patients' perceived benefits, concerns, and suggestions regarding such notes. Major themes of benefits were that simplified plain-language notes may (1) be more useable than unsimplified medical-language notes, (2) improve the patient-clinician relationship, and (3) empower patients through an enhanced understanding of their health care. CONCLUSIONS AI software may translate medical notes into plain-language notes that are perceived as beneficial by patients. Limitations included sample size, inpatient-only setting, and possible confounding factors. Larger studies are needed to assess comprehension. Insight from patient responses to guided interviews can guide the future study and development of this technology.",2020,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","['Twenty patients agreed to participate', 'Study participants were recruited from inpatients at the University of Colorado Hospital']",['standardized medical language version or AI-generated plain-language version of the patient note'],"['mean number of comprehension assessment questions', 'Interview responses', 'comprehension assessment scores', 'comprehension scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.036171,"The mean number of comprehension assessment questions answered correctly was found to be higher in the plain-language group compared with the medical-language group; however, the Student t test was found to be underpowered to determine if this was significant.","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bala', 'Affiliation': 'College of Medicine, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Keniston', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Marisha', 'Initials': 'M', 'LastName': 'Burden', 'Affiliation': 'Division of Hospital Medicine, University of Colorado School of Medicine, Aurora, CO, United States.'}]",JMIR formative research,['10.2196/16670'] 2975,32443302,Analgesia for spinal anesthesia positioning in elderly patients with proximal femoral fractures: Dexmedetomidine-ketamine versus dexmedetomidine-fentanyl.,"Elderly patients with femoral fractures are anticipated to endure the most pain caused by positional changes required for spinal anesthesia. To improve pain relief, we compared the analgesic effects of intravenous dexmedetomidine-ketamine and dexmedetomidine-fentanyl combinations to facilitate patient positioning for spinal anesthesia in elderly patients with proximal femoral fractures. Forty-six patients were randomly assigned to two groups and received either 1 mg/kg of intravenous ketamine (group K) or 1 μg/kg of intravenous fentanyl (group F) concomitant with a loading dose of dexmedetomidine 1 μg/kg over 10 minutes, then dexmedetomidine infusion only was continued at 0.6 μg/kg/h for following 20 minutes, and titrated at a rate of 0.2 to 0.6 μg/kg/h until the end of surgery. After completion of the infusion of either ketamine or fentanyl, the patients were placed in the lateral position with the fracture site up. The pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation) was used to describe the pain intensity in each step during the procedure (lateral positioning, hip flexion, and lumbar puncture), and quality score (0 = poor hip flexion, 1 = satisfactory hip flexion, 2 = good hip flexion, and 3 = optimal hip flexion) was used to describe the quality of posture. Group K showed a median pain score of 0 (0-1), 0 (0-0) and 0 (0-0) in lateral positioning, hip flexion and lumbar puncture, respectively, while group F showed a score of 3 (2.75-3), 3 (2-3) and 0 (0-1), respectively. The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups. The administration of dexmedetomidine-ketamine showed a greater advantage in reducing pain intensity and increasing the quality with patient positioning during spinal anesthesia in elderly patients with proximal femoral fractures, without any serious adverse effects.",2020,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","['elderly patients with proximal femoral fractures', 'Elderly patients with femoral fractures', 'Forty-six patients']","['dexmedetomidine-fentanyl combinations', 'dexmedetomidine-ketamine', 'Dexmedetomidine-ketamine', 'Analgesia', 'dexmedetomidine-fentanyl', 'fentanyl (group F) concomitant with a loading dose of dexmedetomidine', 'intravenous ketamine', 'ketamine or fentanyl', 'dexmedetomidine']","['median pain score', 'pain relief', 'hip flexion', 'quality scores of spinal anesthesia positioning', 'pain intensity', 'pain score in lateral positioning', 'pain score', 'bradycardia, hypotension, and desaturation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",46.0,0.0817178,"The pain score in lateral positioning (P < .0001) and hip flexion (P < .0001) was significantly lower in group K than group F. Group K showed the significantly higher quality scores of spinal anesthesia positioning (P = .0044) than group F. Hemodynamic adverse effects, such as bradycardia, hypotension, and desaturation, were not significantly different between the groups.","[{'ForeName': 'Ki Hwa', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Inje University Haeundae Paik Hospital, Haeundaegu, Busan, Republic of Korea.'}, {'ForeName': 'Soo Jee', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Se Hun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hyunseong', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Dae Seok', 'Initials': 'DS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Yong Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yei Heum', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyojoong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020001'] 2976,32444166,Effective support following recurrent pregnancy loss: a randomized controlled feasibility and acceptability study.,"RESEARCH QUESTION Is it feasible to perform a future definitive trial to determine the effectiveness of the positive reappraisal coping intervention (PRCI) in improving the psychological well-being of women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy? DESIGN This mixed method study aimed to establish the feasibility of conducting a multicentre randomized controlled trial (RCT) to definitively test the effects of the PRCI on the psychological well-being of women with RPL. Participants (n = 75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups. The intervention group received the PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires. Nested within the RCT was a qualitative process evaluation (QPE) exploring participants' subjective experience of study methods and the intervention. The study was conducted over a two-year period between 2014 and 2016. RESULTS This study successfully gathered knowledge about the feasibility aspects of conducting a future multicentre definitive study to determine the effects of the PRCI on the psychological well-being of women with RPL. Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. CONCLUSIONS The study concluded that a definitive RCT of the PRCI is possible and that the model of care already has the potential to be made more widely available as a safe, low-cost, convenient and easily deliverable intervention to provide much-needed support to a vulnerable patient population.",2020,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. ","['women with recurrent pregnancy loss (RPL) during the early stages of a new pregnancy', 'Participants (n\u202f=\u202f75) were recruited to the study and at the point of a positive pregnancy test, 47 were randomized into two study groups', 'two-year period between 2014 and 2016', 'women with RPL']","['positive reappraisal coping intervention (PRCI', 'PRCI and weekly questionnaire assessment (Hospital Anxiety and Depression Scale and Weekly Record Keeping Form [WRK]) to monitor psychological well-being; the control group received the same questionnaires', 'PRCI']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],75.0,0.0546913,"Participants were receptive to its use and the intervention appeared to convey benefits with no apparent downside. ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'University Hospitals Southampton NHS Foundation Trust, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK; Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK. Electronic address: sarahl.bailey@soton.ac.uk.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'School of Psychology, Cardiff University, 70 Park Place, Cardiff Wales CF10 3AT, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kitson-Reynolds', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, University Road, Southampton SO17 1BJ, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': 'Faculty of Medicine, University of Southampton, University Road, Southampton SO17 1BJ, UK; Complete Fertility Centre, Princess Anne Hospital, Coxford Road, Southampton SO16 5YA, UK.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.022'] 2977,32445557,Compression of Myofascial Trigger Points With a Foam Roller or Ball for Exercise-induced Anterior Knee Pain: A Randomized Controlled Trial.,"Objective The study aimed to evaluate the effectiveness of compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles, on exercise-induced, anterior knee pain in fitness runners. Design The research team designed a randomized controlled trial. Setting The study took place in the Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China. Participants A total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center. Intervention The participants were randomly assigned to one of 4 groups, with 20 participants in each group: (1) the MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention. For the MG intervention, participants' MTrPs were compressed with a foam roller or ball for 30 minutes once every 5 days for 2 months. After each compression, the MG+SG group received static stretching immediately. Outcome Measures A visual analog scale (VAS) and a participant's range of motion (ROM) of the knee were assessed at baseline, after 4 weeks of the intervention, immediately postintervention, and at a follow-up at 8 weeks postintervention. The effectiveness of the treatment in the different groups was also compared. Results Immediately postintervention, 18 participants (90%) in MG+SG group, 12 (60%) in MG group, and 8 (40%) in the SG group were pain free. Compared with those at baseline, the VAS scores of the MG+SG group significantly improved between baseline and postintervention and were unchanged at the eight-week follow-up. In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly. Conclusions Compression of MTrPs with a foam roller or ball, combined with static stretching, was more effective than either the compression only or static stretching only.",2020,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly. ","['induced Anterior Knee Pain', 'Participants\n\n\nA total of 80 participants, 28 males and 52 females with an average age of 37.2 ± 2.9 years, were recruited at the center', 'fitness runners', 'Department of Sports Medicine and Rehabilitation Center of the School of Kinesiology at Shanghai University of Sport in Shanghai, China']","['MG+SG', 'MG+SG group, which received compression with a foam roller or ball (MG) and static stretching (SG); (2) the MG group, which received compression only; (3) the SG group static, which received static stretching only; or (4) the control group (CG), which attended a 30-min class about nutrition or exercise once a month and received no intervention', 'compression of myofascial trigger points (MTrPs) with a foam roller or ball, combined with static stretching of knee muscles', 'Foam Roller or Ball for Exercise', 'static stretching immediately']","['VAS scores and ROMs of the knee', ""visual analog scale (VAS) and a participant's range of motion (ROM) of the knee"", 'pain free', 'VAS scores']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",80.0,0.0309948,"In all groups, the VAS scores and ROMs of the knee increased, but only the MG+SG group's values increased significantly. ","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Qiangmin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Opoku Antwi', 'Affiliation': ''}, {'ForeName': 'Thitham', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 2978,32446208,Absence seizure provocation during routine EEG: Does position of the child during hyperventilation affect the diagnostic yield?,"PURPOSE When performed correctly, hyperventilation (HV) for three minutes provokes absence seizures in virtually all children, a finding suggestive of a diagnosis of childhood absence epilepsy (CAE). Interestingly, some children experience absence seizures while performing HV in the office yet do not experience absences during HV on subsequent routine EEG. In most instances, HV during routine EEG is performed in the supine position, while in the office HV is done with the child sitting-up. Therefore, we hypothesized that the position in which HV is performed may influence its yield in provoking absence seizures. METHODS We conducted a randomized multi-center controlled trial among children (4-10 years old) with suspected CAE. During a routine EEG, children were asked to perform HV twice, in the supine and sitting positions. RESULTS Twenty children (four males) diagnosed with CAE were included in the analysis. Seventeen of the 20 patients experienced absence seizures while sitting and 13 experienced seizures during supine HV (p = 0.031). All patients that had absence seizures during supine HV also had seizures during sitting HV. Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042). An opposite tendency was seen in the younger age group (4-7 years), with shorter seizures in the supine HV group (5.6 seconds supine, 7.57 seconds sitting, p = 0.019). CONCLUSIONS HV in the sitting position may increase the yield of provoking absence seizures during routine EEGs, thereby improving its sensitivity in the diagnosis of CAE.",2020,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","['children (4-10 years old) with suspected CAE', 'Twenty children (four males) diagnosed with CAE']",['routine EEG'],"['sitting HV', 'seizure duration', 'shorter seizures', 'absence seizures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}]",20.0,0.0300237,"Among patients with absences in both positions, seizure duration was significantly shorter during sitting HV (mean 8.69 seconds) than during supine HV (mean 12 seconds) (p = 0.042).","[{'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Rozenblat', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: tal.hakim@gmail.com.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Kraus.dror@gmail.com.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mahajnah', 'Affiliation': 'Institute, Hillel Yaffe Medical Center, The Ruth and Bruce Rappaport Faculty of medicine, Technion University, Israel. Electronic address: MohamedM@hy.health.gov.il.'}, {'ForeName': 'Hadassah', 'Initials': 'H', 'LastName': 'Goldberg-Stern', 'Affiliation': ""Department of Neurology, Schneider Children's Medical Center of Israel, Petah Tiqva, Israel. Electronic address: Hagoldberg@clalit.org.il.""}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Watemberg', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: watembergn@walla.co.il.'}]",Seizure,['10.1016/j.seizure.2020.03.013'] 2979,32447409,Modulation of vocal pitch control through high-definition transcranial direct current stimulation of the left ventral motor cortex.,"Neural interactions between sensorimotor integration mechanisms play critical roles in voice motor control. We investigated how high-definition transcranial direct current stimulation (HD-tDCS) of the left ventral motor cortex modulates neural mechanisms of sensorimotor integration during voice motor control. HD-tDCS was performed during speech vowel production in an altered auditory feedback (AAF) paradigm in response to upward and downward pitch-shift stimuli. In one experiment, two groups received either anodal or cathodal 2 milliamp (mA) HD-tDCS to the left ventral motor cortex while a third group received sham (placebo) stimulation. In a second experiment, two groups received either 1 mA or 2 mA cathodal HD-tDCS to the left ventral motor cortex. Results of the first experiment indicated that the magnitude of vocal compensation was significantly reduced following anodal and cathodal HD-tDCS only in responses to downward pitch-shift AAF stimuli, with stronger effects associated with cathodal HD-tDCS. However, no such effect was observed following sham stimulation. Results of the second experiment indicate that there is not a differential effect of modulation from 1 mA versus 2 mA. Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only. These findings suggest that neurostimulation of the left ventral motor cortex modulates sensorimotor mechanisms underlying voice motor control. We speculate that this effect is associated with the increased contribution of feedforward motor mechanisms, leading to reduced compensatory speech responses to AAF.",2020,"Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only.",[],"['1\xa0mA or 2\xa0mA cathodal HD-tDCS', 'vocal pitch control through high-definition transcranial direct current stimulation', 'HD-tDCS', 'high-definition transcranial direct current stimulation (HD-tDCS', 'anodal or cathodal 2 milliamp (mA) HD-tDCS to the left ventral motor cortex while a third group received sham (placebo) stimulation']",['magnitude of vocal compensation'],[],"[{'cui': 'C0450172', 'cui_str': 'mA - milliampere'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0234789', 'cui_str': 'Vocal pitch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}]",,0.0215293,"Further, these results replicate the directional finding of the first experiment for vocal compensation in response to downward pitch-shift only.","[{'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Bridwell', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hayden', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Fahey', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Dirk-Bart', 'Initials': 'DB', 'LastName': 'den Ouden', 'Affiliation': 'Neurolinguistics Lab, Department of Communication Sciences and Disorders, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA. denouden@sc.edu.'}]",Experimental brain research,['10.1007/s00221-020-05832-9'] 2980,32452896,Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness.,"BACKGROUND Imprecise interpretation of coronary angiograms was reported and resulted in inappropriate revascularization. Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a comprehensive system to evaluate the complexity of the overall lesions. We hypothesized that a real-time SYNTAX score feedback from image analysts may rectify the mis-estimation and improve revascularization appropriateness in patients with stable coronary artery disease (CAD). METHODS In this single-center, historical control study, patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited. During the control period, SYNTAX scores were calculated by treating cardiologists. During the intervention period, SYNTAX scores were calculated by image analysts immediately after coronary angiography and were provided to cardiologists in real-time to aid decision-making. The primary outcome was revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization. RESULTS A total of 3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n = 1525) or the intervention group (03/2017-09/2017, n = 1720). For SYNTAX score tertiles, 17.9% patients were overestimated and 4.3% were underestimated by cardiologists in the control group. After adjustment, inappropriate revascularization significantly decreased in the intervention group compared with the control group (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.73-0.95; P = 0.007). Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group. There was no significant difference in 1-year adverse cardiac events between the control group and the intervention group. CONCLUSIONS Real-time SYNTAX score feedback significantly reduced inappropriate coronary revascularization in stable patients with CAD. CLINICAL TRIAL REGISTRATION Nos. NCT03068858 and NCT02880605; https://www.clinicaltrials.gov.",2020,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"['patients with stable coronary artery disease (CAD', 'stable patients with CAD', 'patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited', '3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n\u200a=\u200a1525) or the intervention group (03/2017-09/2017, n\u200a=\u200a1720']","['Real-time SYNTAX score feedback', 'Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score']","['revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization', 'percutaneous coronary intervention utilization', 'inappropriate revascularization', 'inappropriate coronary revascularization', '1-year adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517603', 'cui_str': '1720'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",3245.0,0.104042,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Si-Peng', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Department of Information Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chen-Fei', 'Initials': 'CF', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fa-Jun', 'Initials': 'FJ', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Hong-Bing', 'Initials': 'HB', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Ke-Fei', 'Initials': 'KF', 'LastName': 'Dou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yi-Da', 'Initials': 'YD', 'LastName': 'Tang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Xie', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chang-Dong', 'Initials': 'CD', 'LastName': 'Guan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000827'] 2981,32449942,Effects of Prazosin on Provoked Alcohol Craving and Autonomic and Neuroendocrine Response to Stress in Alcohol Use Disorder.,"BACKGROUND Chronic alcohol use results in changes to stress biology and autonomic arousal contributing to acute alcohol withdrawal symptoms, neuroendocrine tolerance of the hypothalamic-pituitary-adrenal axis responses, high stress-induced craving, and risk of alcohol relapse. Thus, stress coping and recovery from alcohol during early abstinence may be jeopardized by such stress system dysfunction. Significant preclinical evidence suggests that noradrenergic disruption may contribute to these alcohol-related stress arousal changes and that alpha-1 adrenergic antagonists, such as prazosin, may normalize these stress system adaptations and reduce alcohol intake. Thus, we hypothesized that prazosin would reduce stress-induced craving and improve neuroendocrine and autonomic response to stress and alcohol cue exposure during early abstinence. We secondarily also assessed the role of lifetime anxiety disorders on these prazosin effects. METHODS Forty inpatient treatment-seeking alcohol-dependent individuals were randomly assigned to receive placebo (n = 18) or 16 mg/d, T.I.D., prazosin (n = 22) in a double-blind manner, titrated over 2 weeks. In weeks 3 to 4 after achieving full dose, patients were exposed to 3 5-minute personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue), on 3 consecutive days in a random, counterbalanced order. Alcohol craving, anxiety, heart rate, cortisol, and adrenocorticotropic hormone (ACTH) levels were assessed at baseline, following imagery and at repeated recovery timepoints. RESULTS Prazosin reduced stress cue-induced alcohol craving (p < 0.05) and stress- and alcohol cue-induced anxiety (p < 0.05) and increased heart rate responses in all imagery conditions (p < 0.05). Prazosin lowered basal cortisol and ACTH (p's < 0.05) and attenuated stress cue-induced rises in cortisol (p < 0.05) versus placebo. Finally, in those without lifetime anxiety disorder, the placebo group showed stress- and alcohol cue-induced increases in cortisol (p's < 0.05), while the prazosin group did not. CONCLUSIONS Prazosin may attenuate stress cue-induced alcohol craving and anxiety during early abstinence while improving adrenergic and stress system function, effects which are independent of a history of lifetime anxiety disorders.",2020,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.",['Forty inpatient treatment-seeking alcohol dependent individuals'],"['placebo', 'personalized guided imagery conditions (stress cue, alcohol cue, neutral/relaxing cue', 'prazosin', 'Prazosin']","['stress cue-induced alcohol craving and anxiety', ""basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol"", 'stress cue-induced alcohol craving (p<.05) and stress- and alcohol cue-induced anxiety (p<.05); and increased heart rate responses', 'stress-induced craving and improve neuroendocrine and autonomic response', 'Alcohol craving, anxiety, heart rate, cortisol and ACTH levels', 'stress- and alcohol cue-induced increases in cortisol', 'Provoked Alcohol Craving and Autonomic and Neuroendocrine Response']","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032912', 'cui_str': 'Prazosin'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.0290454,"Prazosin lowered basal cortisol and ACTH (p's<.05), and attenuated stress cue-induced rises in cortisol (p<.05) vs placebo.","[{'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Clinical Neuroscience Research Unit, (GAA), Department of Psychiatry, Connecticut Mental Health Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'From the, Department of Psychiatry, (VM, GH, RS), The Yale Stress Center, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Department of Psychiatry, (HCF), Stony Brook University School of Medicine, Stony Brook, New York.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14378'] 2982,32449960,"Assessing consumers' understanding of the term ""Natural"" on food labeling.","The objective of this study was to gain a better understanding of how consumers' interpret the term ""natural"" by assessing food choice based on labels describing attributes of a product associated with the term ""natural""; to assess food intake of chosen food, and; to determine factors that influence food choice and intake. A randomized, single-visit pilot study was conducted where participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label. Participants were asked to choose and eat the granola (ad libitum) that coincided with what was closest to their view of ""natural."" Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness were measured. ""Organic"" (31%), ""Made with real grains"" (17%), and ""No preservatives"" (15%) were the top three chosen labels. These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049). Income level and age were significantly associated with choice (P = 0.003). Defining the term ""natural"" for use on food labels will require follow-up researchacrosseconomically diverse populations and age groups to understand expectations of food products bearing the term ""natural.""",2020,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).",['participants (n = 105) were presented with seven identical bowls of granola each bearing a different descriptive label'],[],"['Food choice, intake amount, demographics, self-health perception, label use, dietary restraint, and mindfulness']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",105.0,0.0447794,"These choices related to concerns about environment and processing, personal health, and additives and preservatives, respectively (P = 0.049).","[{'ForeName': 'Sajida', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zasadzinski', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Department of Food Science and Nutrition, Center for Nutrition Research, Illinois Institute of Technology, Chicago, IL, 60616, USA.'}]",Journal of food science,['10.1111/1750-3841.15128'] 2983,32452336,Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal.,"AIMS Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal. METHODS In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC). RESULTS We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm. CONCLUSION The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.",2020,Problem Management Plus,"['women and men in an earthquake-affected region of rural Nepal', 'adults in earthquake-affected communities in Nepal', '121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1']","['control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG', 'locally adapted Group PM', 'Group Problem Management Plus', 'PM']","['feasibility and acceptability', 'Acceptability', 'depression symptoms assessed using the Patient Health Questionnaire (PHQ-9']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",121.0,0.0978027,Problem Management Plus,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sangraula', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""van 't Hof"", 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ghimire', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Marahatta', 'Affiliation': 'World Health Organization, Country Office for Nepal, Kathmandu, Nepal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}, {'ForeName': 'M J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000414'] 2984,32454078,Situated food safety behavior.,"Previous studies indicate that many consumers eat rare hamburgers and that information about microbiological hazards related to undercooked meat does not necessarily lead to changed behavior. With this study we aim to investigate whether consumers' willingness to eat hamburgers, both risky and safe, depends on the situation where they are confronted with the food. A representative sample of 1046 Norwegian consumers participated in a web experiment. Participants were randomly divided into four groups. Each group was told to imagine a specific eating situation (at their friend's place, at home, at a restaurant abroad, at a domestic restaurant). Four pictures of hamburgers (rare, medium rare, medium, well-done) were presented in randomized order, and participants rated their intentions to eat each hamburger. Situated risk perception was measured as the stated likelihood of food poisoning from consuming hamburgers in eight different situations. The results show that both risk perception and risk taking vary depending on the situation. In general, participants perceive their own home to be the safest place to consume a hamburger, but they are significantly more likely to consume an undercooked hamburger when at a friend's place. These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception. That risk taking is elevated in situations that may have social consequences should be taken into consideration when developing food safety strategies.",2020,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.",['1046 Norwegian consumers participated in a web experiment'],[],['Situated risk perception'],"[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",1046.0,0.0220725,"These findings indicate that situations play an important role for consumers' likelihood of eating unsafe food, and that risk taking does not always follow risk perception.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Veflen', 'Affiliation': 'BI Norwegian Business School, Norway; Nofima, Norway. Electronic address: nina.veflen@bi.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Røssvoll', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Langsrud', 'Affiliation': 'Nofima, Norway.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Scholderer', 'Affiliation': 'NMBU, Norwegian University of Life Sciences, Norway; University of Zürich, Switzerland.'}]",Appetite,['10.1016/j.appet.2020.104751'] 2985,32456048,Effect of Plyometric versus Ankle Stability Exercises on Lower Limb Biomechanics in Taekwondo Demonstration Athletes with Functional Ankle Instability.,"BACKGROUND This study aimed to compare the effects of plyometric and ankle stability exercises on the dynamic balance and lower limb kinematic and kinetic parameters of Taekwondo demonstration athletes with functional ankle instability. METHODS Fourteen subjects participated in this study and were randomly divided into two groups: a plyometric exercise group ( n = 7) and an ankle stability exercise group ( n = 7). Exercises were performed twice a week for 8 weeks. A Y-balance test was used to measure dynamic balance, and a motion analysis system and force plate were used to collect kinematic and kinetic parameters during single-leg drop landing. A paired t-test was used for intragroup comparisons, and an independent t-test was used for intergroup comparisons. RESULTS In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p < 0.05). The plyometric exercise group decreased their ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion ( p < 0.05). In contrast, the stability exercise increased their ankle plantar flexion at initial contact ( p < 0.05). CONCLUSIONS The plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing. This study suggests that the application of plyometric exercises in ankle rehabilitation would improve stability and shock absorption and help prevent injuries during Taekwondo demonstrations.",2020,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p < 0.05).","['Taekwondo Demonstration Athletes with Functional Ankle Instability', 'Fourteen subjects participated in this study', 'Taekwondo demonstration athletes with functional ankle instability']","['plyometric and ankle stability exercises', 'Plyometric versus Ankle Stability Exercises', 'plyometric exercise group altered their landing strategies using their knee and hip joints to control ankle instability at landing', 'plyometric exercise group ( n = 7) and an ankle stability exercise group', 'plyometric exercises', 'plyometric exercise']","['stability exercise increased their ankle plantar flexion', 'ankle dorsiflexion and increased their knee and hip joint flexion at maximum knee flexion', 'dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement', 'stability and shock absorption']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0576206', 'cui_str': 'Stability of ankle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",14.0,0.0237313,"In both groups, exercise increased dynamic balance and shock absorption and reduced postural sway on the anteroposterior displacement ( p < 0.05).","[{'ForeName': 'Ha Min', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Seunghue', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Physical Therapy, Graduate School, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, Dankook University, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103665'] 2986,32456617,"DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis: a single-center, randomized, double-blind, placebo-controlled study.","BACKGROUND DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. METHODS In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200 mg or 20 mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively. RESULTS 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5% ± 11.4% vs. 85.8% ± 12.5%, p = 0.000), whereas no change was found in placebo group (86.9% ± 11.6% vs. 87.8% ± 11.7%, p = 0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2 = 5.247, OR = 3.31, p = 0.022). CONCLUSIONS NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered (http://www.chictr.org.cn/index.aspx).",2020,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","['patients with carotid artery atherosclerotic stenosis', '2019', 'patients with large cerebral atherosclerotic stenosis', '48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis', '120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA']","['NBP or placebo', 'placebo', 'DL-3-n-butylphthalide', 'Single photon emission computed tomography (SPECT', 'DL-3-n-butylphthalide (NBP', 'NBP']","['CBF amelioration in ipsilateral MCA', 'ROIs with rCBF amelioration and stabilization', 'rCBF in ROIs', 'regional CBF (rCBF', 'cerebral blood flow (CBF', 'cerebral hypoperfusion', 'rCBF change for every ROI and the whole CBF change in MCA territory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}]",120.0,0.605911,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China. shijin_dr9@126.com.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Faguo', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""PET Center, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}]",BMC neurology,['10.1186/s12883-020-01801-5'] 2987,32453647,Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy.,"Background: This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra-rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a substudy of the PRONTO-T1D study. Methods: Ambulatory glucose profiles were evaluated in 269 patients from PRONTO-T1D assigned to double-blind URLi ( n  = 97) or lispro ( n  = 99) given 0-2 min before the start of the meal (mealtime), or open-label URLi ( n  = 73) given 20 min after the meal (postmeal URLi). Blinded CGM was used for up to 14 days before baseline and the 26-week primary endpoint. The primary objective was to compare mealtime URLi and lispro with respect to incremental area under the serum glucose concentration versus time curve from 0 to 2 h (iAUC 0-2h ) after breakfast. Results: Mealtime URLi was superior in reducing the iAUC 0-2h when compared to lispro for breakfast (least squares mean [LSM] difference -28.1 mg·h/L, P  = 0.048) and for all meals combined. iAUC 0-3h and iAUC 0-4h were also reduced. Postmeal URLi resulted in similar postprandial glucose (PPG) control to mealtime lispro, but less optimal PPG control compared to mealtime URLi. Mealtime URLi increased daytime time in range (71-180 mg/dL [3.9-10.0 mmo/L]) (LSM difference = +43.6 min, P  = 0.020) and decreased nighttime time in hypoglycemia (LSM difference ≤70 mg/dL [3.9 mmol/L] = -11.5 min, P  = 0.009) compared to mealtime lispro. Conclusions: Results of this CGM substudy support the improved PPG control seen with mealtime URLi in the PRONTO-T1D study and show that mealtime URLi resulted in improved daytime time in target range.",2020,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"['Type 1 Diabetes', '269 patients from PRONTO-T1D assigned to', 'adults with type 1 diabetes in a sub-study of the PRONTO-T1D study']","['continuous glucose monitoring (CGM', 'ultra rapid lispro (URLi) or lispro used in combination with insulin glargine', 'CGM', 'LSM-diff', 'double-blind URLi', 'lispro (n=99) given 0-2 minutes before the start of the meal (mealtime), or open-label URLi', 'Ultra Rapid Lispro', 'dL', 'Lispro']","['mealtime URLi and lispro with respect to incremental area under the glucose concentration versus time curve', 'daytime time', 'nighttime time in hypoglycemia (LSM-diff ≤70']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",269.0,0.0350752,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"[{'ForeName': 'Maciej T', 'Initials': 'MT', 'LastName': 'Malecki', 'Affiliation': 'Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hardy', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Endocrinologist and Partner, Atlanta Diabetes Associates, Atlanta, Georgia, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Endocrinologist and Executive Director, International Diabetes Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0129'] 2988,32463117,K ATP channels modulate cerebral blood flow and oxygen delivery during isocapnic hypoxia in humans.,"KEY POINTS ATP-sensitive K + (K ATP ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP channels blockade affects the increase in human cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2 ) during hypoxia. Hypoxia-induced increases in the anterior circulation and total cerebral perfusion were attenuated under K ATP channels blockade affecting the relative changes of brain oxygen delivery. Therefore, in humans, K ATP channels activation modulates the vascular tone in the anterior circulation of the brain, contributing to CBF and CDO 2 responses to hypoxia. ABSTRACT ATP-sensitive K + (K ATP ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP channels blockade affects the increase in cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2 ) during hypoxia in humans. Nine healthy men were exposed to 5-min trials of normoxia and isocapnic hypoxia (IHX, 10% O 2 ) before (BGB) and 3 h after glibenclamide ingestion (AGB). Mean arterial pressure (MAP), arterial saturation ( S a O 2 ), partial pressure of oxygen ( P a O 2 ) and carbon dioxide ( P aC O 2 ), internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler ultrasound) and CDO 2 were quantified during the trials. IHX provoked similar reductions in S a O 2 and P a O 2 , while MAP was not affected by oxygen desaturation or K ATP blockade. A smaller increase in ICABF (ΔBGB: 36 ± 23 vs. ΔAGB 11 ± 18%, p = 0.019) but not in VABF (∆BGB 26 ± 21 vs. ∆AGB 27 ± 27%, p = 0.893) was observed during the hypoxic trial under K ATP channels blockade. Thus, IHX-induced increases in tCBF (∆BGB 32 ± 19 vs. ∆AGB 14 ± 13%, p = 0.012) and CDO 2 relative changes (∆BGB 7 ± 13 vs. ∆AGB -6 ± 14%, p = 0.048) were attenuated during the AGB hypoxic trial. In a separate protocol, 6 healthy men (5 from protocol 1) underwent a 5-min exposure to normoxia and IHX before and 3 h after placebo (5 mg of cornstarch) ingestion. IHX reduced S a O 2 and P a O 2 , but placebo did not affect the ICABF, VABF, tCBF, or CDO 2 responses. Therefore, in humans, K ATP channels activation modulates vascular tone in the anterior rather than the posterior circulation of the brain, contributing to tCBF and CDO 2 responses to hypoxia.",2020,"IHX reduced SaO 2 and PaO 2 , but placebo did not affect ICABF, VABF, tCBF, or CDO 2 responses.","['6\xa0healthy men (5 from protocol 1) underwent', 'Nine healthy men', 'humans']","['normoxia and isocapnic hypoxia (IHX, 10% O 2 ) before (BGB) and 3\xa0h after glibenclamide ingestion (AGB', 'IHX', 'KATP channels blockade', '5-min exposure to normoxia and IHX before and 3\xa0h after placebo (5\xa0mg of cornstarch) ingestion', 'KATP channels', 'placebo']","['anterior circulation and total cerebral perfusion', 'ICABF', 'human cerebral blood flow (CBF', 'tCBF', 'Mean arterial pressure (MAP), arterial saturation (SaO 2 ), oxygen (PaO 2 ) and carbon dioxide (PaCO 2 ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2', 'cerebral blood flow (CBF', 'cerebral blood flow and oxygen delivery', 'ICABF, VABF, tCBF, or CDO 2 responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}]",9.0,0.0504265,"IHX reduced SaO 2 and PaO 2 , but placebo did not affect ICABF, VABF, tCBF, or CDO 2 responses.","[{'ForeName': 'Marcos P', 'Initials': 'MP', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'Mattos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Mansur', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Helena N M', 'Initials': 'HNM', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, The Copenhagen Muscle Research Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Antonio C L', 'Initials': 'ACL', 'LastName': 'Nóbrega', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brazil.'}]",The Journal of physiology,['10.1113/JP279751'] 2989,32438817,Effectiveness Comparison of Dexmedetomidine and Remifentanil for Perioperative Management in Patients Undergoing Endoscopic Sinus Surgery.,"BACKGROUND For patients undergoing endoscopic sinus surgery, intranasal injection of epinephrine can cause acute increases in heart rate and blood pressure. OBJECTIVE Among the drugs for reducing hyperdynamic effects, dexmedetomidine and remifentanil are expected to blunt the acute hemodynamic responses after intranasal injection of epinephrine. Our study compared a difference in the 2 drugs in their abilities to blunt the hemodynamic responses in intraoperative period and postoperative profile. METHODS In this study, the patients were randomly divided into the dexmedetomidine and remifentanil groups. During the intraoperative period, the hemodynamic values were recorded. The surgical condition was assessed by a single surgeon. During the postoperative period, hemodynamic values, sedation scale score, and pain score were recorded. RESULT No significant differences in hemodynamic variables were found between the groups before and after intranasal injection of epinephrine. Comparison of the group mean values before endotracheal intubation revealed that the blood pressure values in the remifentanil group were significantly lower than those in the dexmedetomidine group. At 2 minutes after endotracheal intubation, blood pressure and heart rate values in the remifentanil group were significantly lower than those in the dexmedetomidine group. The sedation score was significantly lower in the dexmedetomidine group on arrival and at 30 minutes after arrival at the postanesthetic care unit ( P  < .001 and P  = .001, respectively). At 30 and 60 minutes after the operation, the pain scores were significantly lower in the dexmedetomidine group ( P  = .015 and P  = .001, respectively). CONCLUSION Dexmedetomidine had better postoperative sedative and analgesic effects than remifentanil for patients undergoing endoscopic sinus surgery in this study. Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables. Remifentanil was superior to dexmedetomidine in inducing hypotension during endotracheal intubation.",2020,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","['patients undergoing endoscopic sinus surgery', 'Patients Undergoing Endoscopic Sinus Surgery']","['dexmedetomidine and remifentanil', 'Remifentanil', 'Dexmedetomidine', 'Dexmedetomidine and Remifentanil', 'remifentanil', 'epinephrine', 'dexmedetomidine']","['pain scores', 'heart rate and blood pressure', 'blood pressure and heart rate values', 'postoperative sedative and analgesic effects', 'blood pressure values', 'sedation score', 'acute hemodynamic responses', 'hemodynamic values, sedation scale score, and pain score', 'hypotension', 'hemodynamic variables', 'hemodynamic values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0436728,"Remifentanil and dexmedetomidine attenuated acute hemodynamic responses to be within normal ranges after intranasal injection of epinephrine, and no significant differences in terms of hemodynamic variables.","[{'ForeName': 'Hyub', 'Initials': 'H', 'LastName': 'Huh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Jun', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Young', 'Initials': 'HY', 'LastName': 'Seong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hag', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Zhoo', 'Initials': 'SZ', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang Eun', 'Initials': 'JE', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.'}]",American journal of rhinology & allergy,['10.1177/1945892420927291'] 2990,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903'] 2991,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045'] 2992,32443329,A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections.,"BACKGROUND An increased frequency of toxoplasma encephalitis, caused by Toxoplasma gondii, has been reported in AIDS patients, especially in those with CD4+ T cell counts <100 cells/μL. Several guidelines recommend the combination of pyrimethamine, sulfadiazine, and leucovorin as the preferred regimen for AIDS-associated toxoplasma encephalitis. However, it is not commonly used in China due to limited access to pyrimethamine and sulfadiazine. The synergistic sulfonamides tablet formulation is a combination of trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX), and is readily available in China. Considering its constituent components, we hypothesize that this drug may be used as a substitute for sulfadiazine and TMP-SMX. We have therefore designed the present trial, and propose to investigate the efficacy and safety of synergistic sulfonamides combined with clindamycin for the treatment of toxoplasma encephalitis. METHODS/DESIGN This study will be an open-labeled, multi-center, prospective, randomized, and controlled trial. A total of 200 patients will be randomized into TMP-SMX plus azithromycin group, and synergistic sulfonamides plus clindamycin group at a ratio of 1:1. All participants will be invited to participate in a 48-week follow-up schedule once enrolled. The primary outcomes will be clinical response rate and all-cause mortality at 12 weeks. The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period. DISCUSSION We hope that the results of this study will be able to provide reliable evidence for the efficacy and safety of synergistic sulfonamides for its use in AIDS patients with toxoplasma encephalitis. TRIAL REGISTRATION This study was registered as one of 12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195. This study is still recruiting now, and the first patient was screened on March 22, 2019.",2020,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period. ","['12 clinical trials under the name of a general project at chictr.gov on February 1, 2019, and the registration number of the general project is ChiCTR1900021195', 'difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections', '200 patients', 'AIDS patients with toxoplasma encephalitis']","['clindamycin', 'synergistic sulfonamides plus clindamycin', 'pyrimethamine', 'TMP-SMX plus azithromycin', 'trimethoprim (TMP), sulfadiazine and sulfamethoxazole (SMX', 'pyrimethamine, sulfadiazine, and leucovorin']","['clinical response rate and all-cause mortality', 'clinical response rate and all-cause mortality at 48 weeks, and adverse events']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0085315', 'cui_str': 'Meningoencephalitis due to acquired toxoplasmosis'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0038760', 'cui_str': 'Sulfonamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034283', 'cui_str': 'Pyrimethamine'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038675', 'cui_str': 'Sulfadiazine'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",200.0,0.11167,"The secondary outcomes will be clinical response rate and all-cause mortality at 48 weeks, and adverse events at each visit during the follow-up period. ","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020146'] 2993,32443332,"Research ""recover from illness defense complex"" helper T cell immune mechanisms based on the ""Fuxie"" theory clearing away heat evil thoroughly nourishing kidney treatment of recurrent blood-heat syndrome Psoriasis.","INTRODUCTION Psoriasis vulgaris (PV) is a chronic, painful, disfiguring, and disabling dermatological disease, which affects the physical and mental health of patients and impacts their quality of life. Current conventional systemic therapies can be costly, present risks of side effects, have limited efficacy and commonly recur following treatment cessation. Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate. However, explicit evidence has not yet been obtained. METHODS AND ANALYSIS This is a pilot randomized controlled trial with the objective of investigating the effect of Jia Wei Liang Xue Xiao Feng San granules on relapse rate of recurrent PV and the correlation between Psoriasis area severity index (PASI) and key psoriasis-related cytokine changes and the number of cells. A total of 102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year. A total of 72 patients, with recurrent PV, will be randomized (1:1) to receive the oral Chinese herbal medicine Jia Wei Liang Xue Xiao Feng San or the oral Acitretin Capsule treatments for a period of 8 weeks. After this period, participants whose PASI scores improvement reached more than 75%, will undergo a 52-week follow-up phase.The primary outcome measures are as follows:The secondary study outcomes will include:This trial may provide a novel regimen for recurrent PV patients if the granules decrease recurrence rate without further adverse effects. ETHICS AND DISSEMINATION The ethics approval was provided by the Sichuan Traditional Chinese medicine regional ethics review committee. The ethics approval number is 2018KL-055. The design and the results of the study will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER Chinese Clinical Trial Registry (ChiCTR1900022766).",2020,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","['102 participants were recruited for this study, including 72 patients with recurrent PV, 15 healthy volunteers and 15 patients with psoriasis vulgaris who have recovered for more than 1 year', '72 patients, with recurrent PV']","['oral Chinese herbal medicine Jia Wei Liang Xue', 'Jia Wei Liang Xue Xiao Feng San granules']","['recurrence rate without further adverse effects', 'relapse rate of recurrent PV', 'PASI scores improvement']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.233689,"Some Chinese herbal medicine therapies have shown therapeutic benefits for psoriasis vulgaris, including relieving symptoms and improving quality of life, and a potential of reducing relapse rate.","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Hospital of Chengdu University of traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Ping-Sheng', 'Initials': 'PS', 'LastName': 'Hao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020161'] 2994,32443343,Impact of twice- or three-times-weekly maintenance hemodialysis on patient outcomes: A multicenter randomized trial.,"AIM Maintenance hemodialysis (MHD) frequency is associated with survival and complication rates. Achieving the optimal balance between healthcare, quality of life (QOL), and medical costs is challenging. We compared complications, inflammatory status, nutritional status, and QOL between patients with different MHD frequencies. MATERIAL AND METHODS This was a multicenter randomized trial of patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou. Patients were grouped according to their treatment schedule over 1 year: twice-weekly or 3-times-weekly. Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale) were assessed. RESULTS One hundred forty patients were included aged 29 to 68 years (mean age, 50.9 ± 4.3 years). There were no significant differences in infection, heart failure, or cerebral hemorrhage complications between the 2 groups (P = .664). Pre-dialysis hemoglobin, high-sensitivity C-reactive protein, serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05). After 1 year of MHD, both groups exhibited significant improvements in these parameters (all P < .05) with no significant differences between groups. Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy did not improve after treatment (all P > .05), although a difference in BUN was observed between the 2 groups (P < .001). QOL was superior in the twice-weekly group than in the 3-times-weekly group (all P < .05), except for social support, which was slightly better in the 3-times-weekly group than in the twice-weekly group. CONCLUSIONS Twice- and 3-times-weekly MHD resulted in comparable inflammatory and nutritional clinical outcomes and adverse events. QOL was better for the twice-weekly schedule. Even for patients with economic constraints, twice- or 3-times-weekly MHD should be selected with caution after consideration of BUN levels at baseline.",2020,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","['patients treated between May 2011 and August 2017 at 3 tertiary hospitals in Wenzhou', 'One hundred forty patients were included aged 29 to 68 years (mean age, 50.9\u200a±\u200a4.3 years', 'patient outcomes']",['twice- or three-times-weekly maintenance hemodialysis'],"['Serum creatinine, blood urea nitrogen (BUN), and weekly standard hemodialysis treatment adequacy', 'serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction', 'QOL', 'BUN', 'inflammatory and nutritional clinical outcomes and adverse events', 'infection, heart failure, or cerebral hemorrhage complications', 'survival and complication rates', 'healthcare, quality of life (QOL), and medical costs', 'Complications, biochemistry parameters, and QOL (KDQOL-SFTM 1.3 scale', 'complications, inflammatory status, nutritional status, and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",140.0,0.0354086,"serum albumin, total cholesterol, triglyceride, calcium, phosphate, parathyroid hormone, and ejection fraction were similar in both groups (P > .05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': ""Department of Nephrology, Ruian People's Hospital, Ruian City, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Jinnv', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huanlin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Fadong', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zengqi', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Chusheng', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020202'] 2995,32444306,"Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study.","BACKGROUND In the LIBERTY ASTHMA QUEST (ClinicalTrials.gov: NCT02414854) study, dupilumab 200 mg and 300 mg every 2 weeks vs matched-volume placebo reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902). Here, we examine the safety and efficacy of dupilumab in the subpopulation of Japanese patients who participated in QUEST (n = 114; 6%). METHODS Endpoints assessed were annualized severe exacerbation rates and the effect of treatment over the 52-week treatment period on FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation. RESULTS In Japanese patients, dupilumab 200 and 300 mg every 2 weeks vs matched placebo reduced severe asthma exacerbation rates by 44% (P = 0.33) and 75% (P = 0.03), respectively, and improved FEV 1 at Week 12 by 0.20 L (P = 0.05) and 0.17 L (P = 0.12). FEV 1 improvements were rapid (by Week 2) and sustained throughout treatment. Significant and/or numerical improvements vs placebo in asthma control and quality of life were also observed throughout treatment. For each endpoint, greater efficacy was observed in patients with elevated baseline levels of type 2 inflammatory biomarkers (blood eosinophils or FeNO). Dupilumab treatment significantly reduced levels of FeNO and total IgE, but not blood eosinophils. CONCLUSIONS In this subanalysis of QUEST, the efficacy and safety of dupilumab in Japanese patients was comparable to that observed in the overall intention-to-treat population, suggesting no variability in efficacy on the basis of Japanese ethnicity. (Funded by Sanofi and Regeneron Pharmaceuticals, Inc.; ClinicalTrials.gov number: NCT02414854).",2020,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","['Japanese patients who participated in QUEST (n\xa0=\xa0114; 6', 'Japanese patients with uncontrolled, moderate-to-severe asthma', 'Japanese patients']","['dupilumab', 'placebo']","['annualized severe exacerbation rates', 'Dupilumab efficacy and safety', 'severe asthma exacerbation rates', 'FEV 1 , asthma control, asthma-related quality of life, and markers of type 2 inflammation', 'levels of FeNO and total IgE', 'efficacy and safety', 'safety and efficacy', 'asthma control and quality of life', 'reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.10339,"reduced severe asthma exacerbations and improved lung function (FEV 1 ), asthma control, and quality of life in patients with uncontrolled, moderate-to-severe asthma (N = 1902).","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Kindai University Hospital, Osaka, Japan. Electronic address: tohda@med.kindai.ac.jp.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Yokohama City Minato Red Cross Hospital, Yokohama City, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Allergy Center, National Hospital Organization Mie National Hospital, Tsu, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Yamo', 'Initials': 'Y', 'LastName': 'Deniz', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Naimish', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.04.002'] 2996,32446164,Determination of levels of oxidative stress and nitrosative stress in patients with epilepsy.,"BACKGROUND Epilepsy is one of the most common neurological diseases. The underlying pathophysiological mechanisms in epilepsy are still unknown. Oxidative stress is believed to be one of the factors involved in the pathogenesis of epileptogenesis. In various pathophysiological conditions, reactive nitrogen species (RNS) such as nitrogen and peroxynitrite are produced and these RNSs can bind to free nucleosides and nucleotides or to nucleosides and nucleotides existing in the DNA/RNA structure. 8-Nitroguanine (8-NG) is a typical DNA nucleobase product of nitrosative damage generated by RNS. It has been proposed that F2-isoprostanes, in particular 8-iso-Prostaglandin F2α (8-isoPGF2α), are specific, reliable and non-invasive biomarkers of lipid peroxidation in vivo. In the present study, we compared the levels of lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG in patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants. METHODS The present study comprised 90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy. The patients were assigned into the intervention (n = 45) and control (n = 45) groups. Of the participants in the intervention group, 37.7% (n = 17) were treated with levetiracetam (LEV), 33.3% (n = 15) with valproic acid (VA) and 29% (n = 13) with carbamazepine. Serum 8-iso-PGF2α and 8-NG levels of the participants in the intervention and control groups were determined by ELISA. RESULTS There was no significant difference between the medication (LEV, VA, Carbamazepine) used by the participants and their 8-iso-PGF2α and 8-NG levels (p > 0.05). However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001). CONCLUSION Our study demonstrated that there was an increase in oxidative and nitrosative stres markers in patients with epilepsy. There was no significant difference between the 8-iso-PGF2α and 8-NG levels of the participants taking three different AEDs.",2020,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001). ","['patients with epilepsy undergoing antiepileptic drug (AEDs) treatment and with those in healthy participants', 'patients with epilepsy', '90 patients aged between 17 and 53 who were admitted to the Neurology Clinic of Cumhuriyet University and diagnosed with epilepsy']","['levetiracetam (LEV', 'valproic acid (VA', 'lipid oxidative stress biomarker 8-isoPGF2α and nitrosative stress DNA biomarker 8-NG', 'carbamazepine', '8-Nitroguanine']","['Serum 8-iso-PGF2α and 8-NG levels', 'oxidative stress and nitrosative stress', 'medication (LEV, VA, Carbamazepine', '8-iso-PGF2α and 8-NG', '8-iso-PGF2α and 8-NG levels', 'oxidative and nitrosative stres markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0381956', 'cui_str': '8-nitroguanine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C4505047', 'cui_str': 'Stress, Nitrosative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",90.0,0.0414708,"However, 8-iso-PGF2α and 8-NG were significantly higher in the participants in the intervention than in the participants in the control group (p < 0.001). ","[{'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ersan', 'Affiliation': 'Nigde Ömer Halisdemir University, Medical Faculty, Department of Biochemistry, Niğde, Turkey. Electronic address: serpilersan@gmail.com.'}, {'ForeName': 'Burhanettin', 'Initials': 'B', 'LastName': 'Cigdem', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Neurology, Sivas, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Bakir', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}, {'ForeName': 'H Okan', 'Initials': 'HO', 'LastName': 'Dogan', 'Affiliation': 'Sivas Cumhuriyet University, Medical Faculty, Department of Biochemistry, Sivas, Turkey.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106352'] 2997,32446170,"Independent and combined effect of home-based progressive resistance training and nutritional supplementation on muscle strength, muscle mass and physical function in dynapenic older adults with low protein intake: A randomized controlled trial.","BACKGROUND With the aging phenomenon, there is growing interest in developing effective strategies to counteract dynapenia, the age-related loss of muscle strength. The positive effect of progressive resistance training on muscle strength is well known, however, the effect of nutritional supplementation or its synergistic effect along with exercise on muscle strength is not a consensus in the literature, especially in populations with low protein intake. METHODS We analyzed the muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test) of 69 dynapenic older adults with low protein intake, before and after the intervention period of three months. The participants were randomly allocated into four groups: resistance training, supplementation, resistance training plus supplementation, and control. RESULTS There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (p <  0.001). Considering the outcomes that showed a significant difference between and within groups, only the resistance training group and the resistance training plus supplementation group showed a large effect size in handgrip strength, gait speed, and sit-to-stand test, whereas the supplementation group showed a moderate effect size in gait speed. After the intervention period, there was no difference between the resistance training and the resistance training plus supplementation groups. CONCLUSION This study reinforces the value of resistance training in improving muscle strength. The nutritional supplementation added no further benefits in this specific population. Registration number at the Brazilian registry of clinical trials: RBR-4HRQJF.",2020,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","['dynapenic older adults with low protein intake', '69 dynapenic older adults with low protein intake, before and after the intervention period of three months']","['home-based progressive resistance training and nutritional supplementation', 'progressive resistance training', 'resistance training, supplementation, resistance training plus supplementation, and control']","['muscle strength (handgrip strength and sit-to-stand test), muscle mass, body mass index, insulin resistance, and physical function (gait speed, timed up & go test, and single-leg-stance test', 'gait speed', 'sit-to-stand test ', 'muscle strength, muscle mass and physical function', 'handgrip strength', 'moderate effect size in gait speed', 'handgrip strength, gait speed, and sit-to-stand test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0382378,"There was a significant group x time interaction on the following outcome measures: handgrip strength (p <  0.001), gait speed (p =  0.023), and sit-to-stand test (","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Carvalho Bastone', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: ale.bastone@gmail.com.'}, {'ForeName': 'Luciana Neri', 'Initials': 'LN', 'LastName': 'Nobre', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: lunerinobre@yahoo.com.br.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'de Souza Moreira', 'Affiliation': 'Postgraduate Program in Public Health - Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: onurbsm@yahoo.com.br.'}, {'ForeName': 'Iramaya Francielle', 'Initials': 'IF', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: iramayafranciellerosa@hotmail.com.'}, {'ForeName': 'Gabrielle Bemfica', 'Initials': 'GB', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: gabi_bferreira@hotmail.com.'}, {'ForeName': 'Dayane Deyse Lee', 'Initials': 'DDL', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: dayanedls@hotmail.com.'}, {'ForeName': 'Nancy Krysna Sancha Silva', 'Initials': 'NKSS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: krysnancymonteiro@gmail.com.'}, {'ForeName': 'Michelle Dullya', 'Initials': 'MD', 'LastName': 'Alves', 'Affiliation': 'Department of Nutrition - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: mih.dullya@gmail.com.'}, {'ForeName': 'Rômulo Amaral', 'Initials': 'RA', 'LastName': 'Gandra', 'Affiliation': 'Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: romulogandra@yahoo.com.br.'}, {'ForeName': 'Elane Marinho', 'Initials': 'EM', 'LastName': 'de Lira', 'Affiliation': 'Postgraduate Program in Reabilitation and Functional Performance, Department of Physical Therapy - Universidade Federal dos Vales do Jequitinhonha e Mucuri, Diamantina, Minas Gerais, Brazil. Electronic address: e.lira.fisio@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104098'] 2998,32446172,Effects of 'participatory group-based care management' on wellbeing of older people living alone: a randomized controlled trial.,"BACKGROUND AND OBJECTIVES More knowledge is needed of the effectiveness of complex interventions that aim to promote the wellbeing of older people. This study examines the effects of 'participatory group-based care management' conducted among community-dwelling older adults living alone in Central and Eastern Finland. The intervention aimed to promote wellbeing and quality of life (QoL) using a needs-based and participatory approach. METHODS The study was carried out as a randomized control trial (intervention group n = 185, control group n = 207). In this article, baseline and 6-month follow-up surveys were used. QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust) were used as outcome measurements, and generalized estimating equations (GEE) modeling as the analysis method. Both per-protocol and intention-to-treat analyses were applied. RESULTS According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline. Additionally, the intervention enhanced trust in other people and some dimensions of institutional trust. The intention-to-treat analysis did not result in any significant effects on QoL or loneliness, but some small positive changes in institutional trust were found. CONCLUSIONS Based on some evidence of small positive effects, the intervention may be beneficial in alleviating loneliness and enhancing trust among older people living alone. Because of the contradictory results, more research is needed to examine the complexity of 'participatory group-based care management´ from the perspective of process evaluation.",2020,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","['older people', 'community-dwelling older adults living alone in Central and Eastern Finland', 'older people living alone']",['participatory group-based care management'],"['QoL or loneliness', 'wellbeing and quality of life (QoL', 'QoL. Loneliness', 'QoL (WHOQOL-Bref instrument), loneliness (Revised UCLA Loneliness Scale; single-item question), and trust (two items of generalized trust and six items of institutional trust']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0856593,"According to the per-protocol analysis, the intervention had no effects on QoL. Loneliness decreased among older people with poor QoL at the baseline.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Ristolainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Kannasoja', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Tiilikainen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hakala', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Närhi', 'Affiliation': 'Department of Social Sciences and Philosophy, University of Jyväskylä, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Rissanen', 'Affiliation': 'Department of Social Sciences, University of Eastern Finland, Finland.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104095'] 2999,32448392,Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study.,"BACKGROUND In two recent randomized controlled trials, withholding parenteral nutrition early in critical illness improved outcome as compared to early up-to-calculated-target nutrition, which may be explained by beneficial effects of fasting. Outside critical care, fasting-mimicking diets were found to maintain fasting-induced benefits while avoiding prolonged starvation. It is unclear whether critically ill patients can develop a fasting response after a short-term nutrient interruption. In this randomized crossover pilot study, we investigated whether 12-h nutrient interruption initiates a metabolic fasting response in prolonged critically ill patients. As a secondary objective, we studied the feasibility of monitoring autophagy in blood samples. METHODS In a single-center study in 70 prolonged critically ill patients, 12-h up-to-calculated-target feeding was alternated with 12-h fasting on day 8 ± 1 in ICU, in random order. Blood samples were obtained at the start of the study, at the crossover point, and at the end of the 24-h study period. Primary endpoints were a fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia. Secondary outcomes included serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells. To obtain a healthy reference, mRNA and protein markers of autophagy were assessed in whole blood and isolated white blood cells of 23 matched healthy subjects in fed and fasted conditions. Data were analyzed using repeated-measures ANOVA, Fisher's exact test, or Mann-Whitney U test, as appropriate. RESULTS A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF-I (all p ≤ 0.001). Urea was not affected. BOH was already increased from 4 h fasting onwards. Autophagic markers in blood samples were largely unaffected by fasting in patients and healthy subjects. CONCLUSIONS A 12-h nutrient interruption initiated a metabolic fasting response in prolonged critically ill patients, which opens perspectives for the development of a fasting-mimicking diet. Blood samples may not be a good readout of autophagy at the tissue level. TRIAL REGISTRATION ISRCTN, ISRCTN98404761. Registered 3 May 2017.",2020,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"['patients and healthy subjects', 'critically ill patients', '23 matched healthy subjects in fed and fasted conditions', 'prolonged critically ill patients', '70 prolonged critically ill patients']",['12-h nutrient interruption'],"['metabolic fasting response', 'serum bilirubin and BOH and decreased insulin requirements and serum IGF', 'fasting-induced increase in serum bilirubin and decrease in insulin requirements to maintain normoglycemia', 'BOH', 'Urea', 'serum insulin-like growth factor I (IGF-I), serum urea, plasma beta-hydroxybutyrate (BOH), and mRNA and protein markers of autophagy in whole blood and isolated white blood cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",70.0,0.0616562,A 12-h nutrient interruption significantly increased serum bilirubin and BOH and decreased insulin requirements and serum IGF,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilmer', 'Affiliation': 'Medical Intensive Care Unit, Department of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Schrijvers', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Derese', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gunst', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Michaël P', 'Initials': 'MP', 'LastName': 'Casaer', 'Affiliation': 'Department of Cellular and Molecular Medicine, Clinical Division and Laboratory of Intensive Care Medicine, KU Leuven, Herestraat 49, B-3000, Leuven, Belgium. michael.casaer@uzleuven.be.'}]","Critical care (London, England)",['10.1186/s13054-020-02987-3'] 3000,32450875,Transfer of skills for difficult intubation after videolaryngoscopy training: a randomized simulation study.,,2020,,[],['videolaryngoscopy training'],[],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0560831,,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Kee', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore. Adrian_cl_kee@nuhs.edu.sg.'}, {'ForeName': 'Reyor', 'Initials': 'R', 'LastName': 'Ko', 'Affiliation': 'Ministry of Health Holdings, Singapore, Singapore.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Capistrano', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Dajac', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Juvel', 'Initials': 'J', 'LastName': 'Taculod', 'Affiliation': 'Division of Critical Care -- Respiratory Therapy, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Kay Choong', 'Initials': 'KC', 'LastName': 'See', 'Affiliation': 'Division of Respiratory and Critical Care Medicine, National University Hospital, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore, 119228, Singapore.'}]","Critical care (London, England)",['10.1186/s13054-020-02982-8'] 3001,32459035,"A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter Clinical Trial to Assess the Safety of 0.005% Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women with Early Stage Breast Cancer in Treatment with Aromatase Inhibitor in the Adjuvant Setting.","LESSONS LEARNED The levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone remained unchanged after a 12-week treatment with 0.005% estriol vaginal gel in postmenopausal women receiving nonsteroidal aromatase inhibitors for hormone receptor-positive early breast cancer. These results support the safety of 0.005% estriol vaginal gel for the treatment of bothering symptoms of vulvovaginal atrophy in breast cancer survivors. The results provide clinicians with confidence in the use of this product in women who do not experience symptom relief with nonhormonal remedies. BACKGROUND Symptoms of vulvovaginal atrophy associated with treatment with nonsteroidal aromatase inhibitors (NSAIs) negatively impact patients' quality of life and may affect adherence to NSAIs. Vaginal estrogens effectively improve these symptoms, although their safe use in breast cancer survivors remains unclear. METHODS Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness were randomized to 0.005% estriol vaginal gel or placebo for 12 weeks. Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH), were analyzed at baseline and at weeks 1, 3, 8, and 12. The primary safety outcome was the variation in serum FSH from baseline to week 12. RESULTS Sixty-one women (mean age, 59 years) enrolled in the study. Small oscillations were observed in FSH and LH, although they were always maintained within the postmenopausal range. No significant differences were found in the variation of FSH and LH between baseline and week 12 from the physiological variation observed before treatment. Women receiving 0.005% estriol vaginal gel had slightly increased estriol levels at weeks 1 and 3, with a subsequent reduction until normalizing at week 12; estradiol and estrone remained the below limit-of-quantitation in almost all samples. CONCLUSION Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI. A transient negligible absorption of estriol and a nonsignificant variation of FSH after 12 weeks were observed. These findings provide confidence for the safe use of 0.005% estriol vaginal gel in women with breast cancer with an indication for treatment with vaginal estrogens.",2020,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","['women with breast cancer with an indication for treatment with vaginal estrogens', 'Postmenopausal women with hormone receptor-positive early breast cancer receiving NSAI and moderate-to-severe vaginal dryness', 'postmenopausal women receiving', 'women with breast cancer receiving NSAI', 'breast cancer survivors', 'Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting', 'women who do not experience symptom relief with nonhormonal remedies', 'Sixty-one women (mean age, 59\u2009years) enrolled in the study']","['estriol vaginal gel', 'nonsteroidal aromatase inhibitors (NSAIs', 'Placebo', 'Estriol Vaginal Gel', 'Ultralow-dose 0.005% estriol vaginal gel', 'estriol vaginal gel or placebo', 'nonsteroidal aromatase inhibitors']","['Circulating estrogens, follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'variation of FSH and LH', 'variation in serum FSH', 'estrogens, FSH, and LH levels', 'estriol levels', 'levels of circulating follicle-stimulating hormone, luteinizing hormone, estriol, estradiol, and estrone']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517389', 'cui_str': '0.005'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0337435', 'cui_str': 'Estriol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014927', 'cui_str': 'Estriol'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}]",61.0,0.0682912,"Ultralow-dose 0.005% estriol vaginal gel did not significantly influence estrogens, FSH, and LH levels in women with breast cancer receiving NSAI.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sánchez-Rovira', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario de Jaén, Jaén, Spain.'}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institute and Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gil-Gil', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo-De Las Heras', 'Affiliation': 'GEICAM Spanish Breast Cancer Group, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Nieto-Magro', 'Affiliation': 'Medical Department, Italfarmaco, SA, Madrid, Spain.'}]",The oncologist,['10.1634/theoncologist.2020-0417'] 3002,32456170,Acute Effects of a Short Bout of Physical Activity on Cognitive Function in Sport Students.,"Physical activity is a promising intervention to restore cognitive function after prolonged sedentary periods. However, little is known about the effect of short physical activity bouts on cognition especially among individuals that are used to physical activity. Therefore, the goal of the present study was to assess the impact of a single ten-minute physical activity bout on the cognitive domain of visual attention compared to sedentary behavior in a population of physically active sport students. Using a randomized controlled design, 51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female] were allocated to one of the following interventions in the break of a two-hour study course: physical activity group (running for ten minutes) and sedentary control group. Visual attention was measured post-intervention using a modified trail making test. Pre-, post-, and 30 min after intervention, perceived attention, and affective states were measured. Between-group comparisons were used to analyze whether visual attention and/or changes in perceived attention or affective states differed between groups. The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group, p = 0.003, d = 0.89. Perceived attention, p = 0.006, d = 0.87, and arousal, p < 0.001, d = 1.68, showed a significantly larger pre- and post-intervention increase in the physical activity group compared with the sedentary control group, which was not evident 30 min after intervention. A single ten-minute running intervention in study breaks might help to restore the basal visual attentional domain of cognition after prolonged sedentary periods more effectively compared with common sedentary behavior in breaks between study lessons.",2020,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group, ","['population of physically active sport students', 'Sport Students', '51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female']","['physical activity group (running for ten minutes) and sedentary control group', 'Short Bout of Physical Activity']","['visual attention and/or changes in perceived attention or affective states', 'basal visual attentional domain of cognition', 'visual attention', 'perceived attention, and affective states', 'Cognitive Function', 'Visual attention']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",51.0,0.061781,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group, ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steidl-Müller', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17103678'] 3003,32463430,Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial.,"Importance Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age. Objective To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA. Design, Setting, and Participants This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018. Interventions Adenotonsillectomy. Main Outcomes and Measures The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses. Polysomnography and the OSA-18 questionnaire were completed at baseline and after 6 months. Results Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA-18 questionnaire (eg, total OSA-18 score: -17; 95% CI, -24 to -10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (-3.1; 95% CI, -5.7 to -0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline. Conclusions and Relevance This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE. Trial Registration ClinicalTrials.gov Identifier: NCT02315911.",2020,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","['With Mild to Moderate Obstructive Sleep Apnea', 'children between 2 and 4 years of age', '60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n\u2009=\u200929) or', 'healthy children with mild to moderate OSA.\nDesign, Setting, and Participants', 'A total of 53 participants (88%; ATE, n\u2009=\u200925; watchful waiting, n\u2009=\u200928) completed the study', '60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months', 'December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden', 'Young Children', 'Data were analyzed from August 2018 to December 2018', 'children with obstructive sleep apnea (OSA']","['Adenotonsillectomy vs Watchful Waiting', 'Adenotonsillectomy (ATE', 'ATE', 'watchful waiting']","['quality of life', 'polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses', 'mean OAHI score change', 'mean OAHI score', 'Polysomnography and the OSA-18 questionnaire', 'OSA-18 questionnaire']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.10545,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Browaldh', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.0869'] 3004,32463456,Effect of Osimertinib and Bevacizumab on Progression-Free Survival for Patients With Metastatic EGFR-Mutant Lung Cancers: A Phase 1/2 Single-Group Open-Label Trial.,"Importance The combination of erlotinib and bevacizumab as initial treatment of epidermal growth factor receptor (EGFR [OMIM 131550])-mutant lung cancers improves progression-free survival (PFS) compared with erlotinib alone. Because osimertinib prolongs PFS compared with erlotinib, this trial was designed to study the combination of osimertinib and bevacizumab as first-line treatment. Objectives To determine the safety and tolerability of osimertinib and bevacizumab combination treatment and assess the 12-month PFS of the combination in patients with metastatic EGFR-mutant lung cancers. Design, Setting, and Particiants From August 15, 2016, to May 15, 2018, 49 patients with metastatic EGFR-mutant lung cancers were enrolled in this interventional clinical trial, conducted at a single academic cancer center. In the phase 1 portion of the study, a standard 3 + 3 dose de-escalation design was used to determine the maximum tolerated dose of osimertinib and bevacizumab. In the phase 2 portion of the study, patients were treated at the maximum tolerated dose defined in the phase 1 portion. Statistical analysis was performed from August 1 to October 1, 2019. Interventions All patients received osimertinib, 80 mg daily, and bevacizumab, 15 mg/kg once every 3 weeks. Main Outcomes and Measures The primary objective of the phase 2 portion of the study was to determine the number of patients receiving the combination of osimertinib and bevacizumab who were progression free at 12 months. Secondary end points included overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment. Results Among the 49 patients in the study (34 women; median age, 60 years [range, 36-83 years]), PFS at 12 months was 76% (95% CI, 65%-90%). The overall response rate was 80% (95% CI, 67%-91%), and median PFS was 19 months (95% CI, 15-24 months). Of the 6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response. Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002). Identified mechanisms of resistance included squamous cell transformation (n = 2) pleomorphic transformation (n = 1), and acquired EGFR L718Q (n = 1) and C797S (n = 1) mutations. Conclusions and Relevance The combination of osimertinib and bevacizumab met the study's prespecified effectiveness end point. Persistent EGFR-mutant circulating tumor DNA at 6 weeks was associated with early progression and shorter survival. A randomized phase 3 study comparing osimertinib and bevacizumab with osimertinib alone is planned. Trial Registration ClinicalTrials.gov Identifier: NCT02803203.",2020,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","['patients with metastatic EGFR-mutant lung cancers', '6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response', '49 patients in the study (34 women; median age, 60 years [range, 36-83 years', '49 patients with metastatic EGFR-mutant lung cancers', 'Patients With Metastatic EGFR-Mutant Lung Cancers']","['Osimertinib and Bevacizumab', 'erlotinib and bevacizumab', 'osimertinib and bevacizumab', 'bevacizumab']","['early progression and shorter survival', 'overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment', 'safety and tolerability', 'median overall survival (clearance', 'median PFS (clearance', 'overall response rate', 'Progression-Free Survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",49.0,0.125856,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","[{'ForeName': 'Helena A', 'Initials': 'HA', 'LastName': 'Yu', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Makhnin', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Rizvi', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tsui', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Falcon', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Houck-Loomis', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Fanli', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Julie Li', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Tobi', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ahn', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hayes', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Arcila', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Chaft', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ladanyi', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Riely', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kris', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1260'] 3005,32463470,Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial.,"Importance Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed. Objective To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. Design, Setting, and Participants This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Interventions Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Main Outcomes and Measures Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. Results A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups. Conclusions and Relevance Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. Trial Registration EU Clinical Trials Register Identifier: 2007-005352-17.",2020,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. ","['Apathy in Alzheimer Disease', '108 patients (mean [SD] age, 74.8 [5.9] years', 'Patients with additional clinically relevant depressed mood were excluded', 'psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany', ' 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive', 'patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood', 'Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included', 'patients with dementia of Alzheimer type']","['Bupropion', 'dopamine and noradrenaline reuptake inhibitor bupropion', 'donepezil or galantamine', 'bupropion or placebo', 'bupropion', 'placebo']","['AES-C score', 'numbers of adverse events', 'health-related quality of life', 'total neuropsychiatric symptoms', 'neuropsychiatric symptoms, cognition, activities of daily living, and quality of life', 'Apathy Evaluation Scale-Clinician Version (AES-C', 'efficacy and safety', 'serious adverse events', 'baseline AES-C score', 'cognition', 'activities of daily living']","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3665464', 'cui_str': ""Dementia in Alzheimer's disease, unspecified""}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",108.0,0.521266,"Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. ","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Spottke', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Bach', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bartels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Buerger', 'Affiliation': 'Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dodel', 'Affiliation': 'Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fellgiebel', 'Affiliation': 'Center for Mental Health in Old Age, Landeskrankenhaus, Mainz, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fliessbach', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Frölich', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Hausner', 'Affiliation': 'Department of Geriatric Psychiatry, Zentralinstitut für Seelische Gesundheit Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klöppel', 'Affiliation': 'University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Klostermann', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kornhuber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Laske', 'Affiliation': 'German Center for Neurodegenerative Diseases, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Peters', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': 'German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Richter-Schmidinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Kija', 'Initials': 'K', 'LastName': 'Shah-Hosseini', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Teipel', 'Affiliation': 'German Center for Neurodegenerative Diseases, Rostock, Germany.'}, {'ForeName': 'Christine A F', 'Initials': 'CAF', 'LastName': 'von Arnim', 'Affiliation': 'Department of Neurology, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiltfang', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University, Goettingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry, University Hospital Cologne, Medical Faculty, Cologne, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6027'] 3006,32460752,The efficacy of a mobile phone application to improve adherence to treatment and self-management in people with chronic respiratory disease in Romanian population - a pilot study.,"BACKGROUND Many studies assessed the effect of mobile phone applications on self-management outcomes in patients with asthma, but all of them presented variable results. In this paper. we examined the effect of a mobile phone application on self-management and disease control in Romanian population. METHODS This study included 93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment. Patients were divided into two groups. The first group included patients that received treatment, and the second group received treatment and also used the smartphone application. Number of exacerbations and asthma control test (ACT) were recorded. RESULTS The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001). Also, we found significant differences between the ACT score with-in each group, observing a significant improvement of the score between evaluations and baseline (related-samples Friedman's test with Bonferroni correction, p <  0.001). When considering the exacerbations rate, significantly less patients using the application presented exacerbations, 10.30% vs. 46.30% (Pearson Chi-square test, X 2 (1) = 13.707, p <  0.001). CONCLUSION Our study indicates that smartphone applications are an effective way to improve asthma control and self-management when used continually in our population. We found significant positive effects in disease control and exacerbation frequency.",2020,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","['93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment', 'patients with asthma', 'Romanian population', 'people with chronic respiratory disease in Romanian population ']","['mobile phone applications', 'smartphone application', 'mobile phone application']","['Number of exacerbations and asthma control test (ACT', 'exacerbations rate', 'ACT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",93.0,0.0376453,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","[{'ForeName': 'Laura Adela', 'Initials': 'LA', 'LastName': 'Munteanu', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Frandes', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania. mirela.frandes@umft.ro.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Timar', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Tudorache', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Ariadna Petronela', 'Initials': 'AP', 'LastName': 'Fildan', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Oancea', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Doina Ecaterina', 'Initials': 'DE', 'LastName': 'Tofolean', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}]",BMC health services research,['10.1186/s12913-020-05340-0'] 3007,32460773,Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.,"BACKGROUND Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial. METHODS Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods. DISCUSSION The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.",2020,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","['patients with chronic upper limb spasticity following stroke', '139 participants from 6 stroke units across 3 Australian states are participating in the trial']",[],"['cost utility analysis', 'incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained', 'incremental Quality Adjusted Life Year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",139.0,0.148825,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Milte', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia. rachel.milte@flinders.edu.au.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'Discipline of Physiotherapy, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Department of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia.'}]",BMC health services research,['10.1186/s12913-020-05333-z'] 3008,32444201,Guided versus freehand acromioplasty during rotator cuff repair. A randomized prospective study.,"INTRODUCTION There is no consensus on how to perform acromioplasty, particularly regarding the level and extent of bone resection, which depend on scapular and humeral morphologies. HYPOTHESIS We aimed to determine whether computer-assisted acromioplasty planning helps surgeons remove impinging bone, reduce unnecessary resections, and improve short-term outcomes of rotator cuff tears (RCR). PATIENTS AND METHODS We randomized 64 patients undergoing RCR of full-thickness supraspinatus tears into two groups: 'guided acromioplasty' (GA) and 'freehand acromioplasty' (FA). The pre- and post-operative scapula models were reconstructed using computed-tomography scans to quantify impinging bone removal, unnecessary bone resections, and identify zones of acromial bone removal. All patients were evaluated preoperatively and at 6 months to assess their range of motion (ROM), functional scores and tendon integrity using ultrasound. RESULTS The two groups did not differ in demographics, clinical or morphologic characteristics. Compared to FA, GA tended to lower impinging bone removal (55±26% vs. 43±27%, p=0.087) and to increase unnecessary resection of the total bone removed (49±22% vs. 57±27%, p=0.248). GA resulted in significant anterior under-resection, while FA resulted in significant medial over-resection. Clinical outcomes and ROM improved significantly for all patients, except for internal rotation in the GA group. There were no other significant differences between the two groups, neither in terms of post-operative scores nor in terms of clinical net improvements, nor tendon repair integrity. CONCLUSIONS This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes. Nonetheless such planning tools could help less experienced surgeons improve the efficacy of acromioplasty. LEVEL OF PROOF I, Randomized controlled trial (Therapeutic study).",2020,"This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes.",['64 patients undergoing RCR of full-thickness supraspinatus tears into two groups: '],"['Guided versus freehand acromioplasty during rotator cuff repair', 'computer-assisted acromioplasty planning', ""guided acromioplasty' (GA) and 'freehand acromioplasty' (FA""]","['LEVEL OF PROOF', 'ROM', 'clinical net improvements, nor tendon repair integrity', 'range of motion (ROM), functional scores and tendon integrity using ultrasound', 'unnecessary resection of the total bone', 'impinging bone removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0186663', 'cui_str': 'Acromioplasty of shoulder'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0556981', 'cui_str': '% proof'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565350', 'cui_str': 'Plastic repair of tendon'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",64.0,0.0640378,"This computer-assisted planning for acromioplasty during RCR proved no benefits in terms of bone removal, tendon healing, or clinical outcomes.","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lädermann', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Avenue J.-D.-Maillard 3, 1217 Meyrin, Switzerland; Faculty of Medicine, University of Geneva, Geneva, Switzerland; Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Geneva, Switzerland. Electronic address: alexandre.laedermann@gmail.com.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Chagué', 'Affiliation': 'Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Preissmann', 'Affiliation': 'Center for Psychiatric Neuroscience, Department of Psychiatry, Lausanne University Hospital, CH-1008 Prilly, Switzerland.'}, {'ForeName': 'Franck C', 'Initials': 'FC', 'LastName': 'Kolo', 'Affiliation': 'Rive Droite Radiology Center, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Rime', 'Affiliation': 'Division of Physiotherapy, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Kevelham', 'Affiliation': 'Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Bothorel', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Caecilia', 'Initials': 'C', 'LastName': 'Charbonnier', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland; Medical Research Department, Artanim Foundation, Meyrin, Switzerland.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.02.010'] 3009,22479610,Experimental study of informal rewards in peer production.,"We test the effects of informal rewards in online peer production. Using a randomized, experimental design, we assigned editing awards or ""barnstars"" to a subset of the 1% most productive Wikipedia contributors. Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.",2012,"Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.",[],[],[],[],[],[],,0.0181126,"Comparison with the control group shows that receiving a barnstar increases productivity by 60% and makes contributors six times more likely to receive additional barnstars from other community members, revealing that informal rewards significantly impact individual effort.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Restivo', 'Affiliation': 'Department of Sociology, State University of New York at Stony Brook, New York, New York, United States of America. michael.restivo@stonybrook.edu'}, {'ForeName': 'Arnout', 'Initials': 'A', 'LastName': 'van de Rijt', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0034358'] 3010,32450367,Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.,"Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m 2 ) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.",2020,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","['150 participants (76.1% female, 55.8% white, BMI\u202f=\u202f38.8\u202f±\u202f4.8\u202fkg/m 2 ']","['intensive behavioral therapy (IBT', 'IBT alone, IBT with liraglutide 3.0\u202fmg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'liraglutide']","['Early weight loss', 'weight loss', 'total weight loss', 'visit attendance, dietary self-monitoring, medication, and meal-replacement adherence', 'self-monitoring and medication adherence', 'medication adherence']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517765', 'cui_str': '4.8'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",150.0,0.0213041,"In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, USA.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, USA; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103639'] 3011,32450456,The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial.,"BACKGROUND AND AIMS The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial. METHODS AND RESULTS The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the ""all-comer"" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.",2020,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","['patients undergoing percutaneous coronary intervention', 'patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial']",['percutaneous coronary intervention (PCI'],"['PHR and BARC 3 or 5 bleeding', 'primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5', 'PHR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",,0.296061,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","[{'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Klinikum Fulda, Medizinische Klinik I, Fulda, Germany.'}, {'ForeName': 'Gincho', 'Initials': 'G', 'LastName': 'Tonev', 'Affiliation': ""Multi-profile Hospital for Active Treatment, St George's University, Plovdiv, Bulgaria.""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eeckhout', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Van Geuns', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.04.010'] 3012,32450497,Effect of brexpiprazole on control of impulsivity in schizophrenia: A randomized functional magnetic resonance imaging study.,"Impulsivity in schizophrenia is a risk factor for suicide, drug abuse, and other risk-taking behaviors. This exploratory, multicenter, randomized, double-blind, functional magnetic resonance imaging (fMRI) study assessed the effects of brexpiprazole on brain regions that control impulsive behavior. Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms were randomized to 6 weeks of brexpiprazole 2 or 4 mg/day. The prespecified outcome measure was blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task. Secondary objectives evaluated the efficacy, safety and tolerability of brexpiprazole. Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task. Brexpiprazole was also associated with significantly improved stop-signal reaction time (SSRT). No worsening of psychiatric symptoms, functioning, or impulsivity occurred in these patients. No unexpected safety or tolerability concerns were identified. In conclusion, brexpiprazole treatment among patients with schizophrenia and impulsivity was associated with decreased right VLPFC activation and decreased SSRT, supportive of a benefit of brexpiprazole on inhibition-related brain activation and behavior. ClinicalTrials.gov identifier: NCT02194933.",2020,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","['Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms', 'schizophrenia', 'patients with schizophrenia and impulsivity']","['brexpiprazole', 'functional magnetic resonance imaging (fMRI', 'Brexpiprazole']","['blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task', 'right VLPFC BOLD activation', 'safety or tolerability concerns', 'right VLPFC activation', 'psychiatric symptoms, functioning, or impulsivity', 'efficacy, safety and tolerability of brexpiprazole', 'stop-signal reaction time (SSRT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",38.0,0.07473,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","[{'ForeName': 'Theo Gm', 'Initials': 'TG', 'LastName': 'van Erp', 'Affiliation': 'Clinical and Translational Neuroscience Laboratory, University of California-Irvine, Irvine, CA, United States; Center for the Neurobiology of Learning and Memory, University of California-Irvine, Irvine, CA, United States. Electronic address: tvanerp@uci.edu.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okame', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, IL, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'University of California-Irvine, Irvine, CA, United States; Tibor Rubin Veterans Affairs Medical Center, Long Beach, CA, United States. Electronic address: sgpotkin@gmail.com.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111085'] 3013,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 ​min after blinded oral administration of placebo and 10 mg/70 ​kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study used a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980'] 3014,32454317,Web-based experiential learning strategies to enhance the evidence-based-practice competence of undergraduate nursing students.,"BACKGROUND Evidence-based practice (EBP) is considered a key competence for practicing high-quality and safe nursing. However, undergraduate nursing programs continue to provide traditional classroom teaching strategies that have limitations in facilitating the development of critical competences for engaging in EBP in real clinical contexts. OBJECTIVE AND DESIGN The purpose of this study was to develop a web-based experiential learning program aimed at improving the engagement and experience of nursing students in EBP. A quasi-experimental research with non-equivalent control-group with non-synchronized design was used to describe the process of program development and the innovative learning method, and discuss the outcomes of the program. METHODS The experimental group was exposed to a web-based experiential learning program, while the control group received traditional learning with written material. Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence were evaluated to assess the effects of the program. RESULTS The result showed that web-based experiential learning strategies were effective in significantly improving the EBP knowledge and skills score (F = 12.29, p = .001) and the score for confidence in asking clinical questions (F = 12.14, p = .001). The attitudes toward EBP (F = 0.75, p = .389) and practice score (F = 3.22, p = .076) did not show a significant difference between the experimental group and the control group. CONCLUSION The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students. Based on the study results, we suggest using web-based experiential learning to supplement the traditional learning method or as the mainstream learning method for nursing students.",2020,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"['undergraduate nursing students', 'nursing students in EBP']","['web-based experiential learning program, while the control group received traditional learning with written material']","['Self-reported EBP scores (knowledge and skills, attitude, and practice) and clinical-questioning confidence', 'practice score', 'EBP knowledge and skills score']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0182641,The web-based experiential learning was found to be an effective method for enhancing the EBP competence of nursing students.,"[{'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'College of Nursing, Chungnam National University, Republic of Korea. Electronic address: miri9912@naver.com.'}, {'ForeName': 'Mihyun', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Daejeon Health Institute of Technology, Republic of Korea.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cullen', 'Affiliation': 'Department of Nursing Services and Patient Care, University of Iowa Hospitals and Clinics, United States of America.'}]",Nurse education today,['10.1016/j.nedt.2020.104466'] 3015,32456618,"Effectiveness of mobile SMS based counselling intervention in improving the knowledge, attitude, and practices of HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia: a mixed mode study protocol.","BACKGROUND HIV/AIDS is one of the most serious problems in many parts of the world, and is a high priority for health managers and decision-makers. The aim of the qualitative part of this study will be to develop a mobile SMS (short messaging services) counselling intervention to prevent HIV/AIDS, while the quantitative part will be to test the effectiveness of a mobile SMS counselling intervention to improve the knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS. METHOD A mixed methods approach will be used. Qualitative part: Design: focus group discussions (FGDs) will be conducted. SETTING Hospital/NGOs in Terengganu, Malaysia. PARTICIPANTS Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders. One FGD will be conducted for each group. Three in-depth interviews (IDIs) will be conducted with patients who had HIV/AIDS, of which one will be female. Quantitative part: Design: a cluster randomized clinical trial with 384 HIV/AIDS patients in Terengganu, Malaysia. INTERVENTION Mobile SMS counselling intervention for patients concerning the prevention of HIV/AIDS. RESULTS The main outcomes of this study will be the differences in knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS between the baseline and immediate follow-up after the intervention, and after 3 months. CONCLUSIONS The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia. TRIAL REGISTRATION Thai Clinical Trials Registry, TCTR20200212001; 7/02/2020.",2020,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia. ","['Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders', '384 HIV/AIDS patients in Terengganu, Malaysia', 'Hospital/NGOs in Terengganu, Malaysia', 'HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia', 'patients who had HIV/AIDS, of which one will be female']","['mobile based SMS counselling intervention', 'mobile SMS based counselling intervention', 'Mobile SMS counselling intervention', 'mobile SMS counselling intervention']","['knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",384.0,0.220058,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia. ","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia. md.hossain@umt.edu.my.'}, {'ForeName': 'Ruhani Binti Mat', 'Initials': 'RBM', 'LastName': 'Min', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Zikri', 'Initials': 'Z', 'LastName': 'Muhammad', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan K C', 'Initials': 'KKC', 'LastName': 'Mani', 'Affiliation': 'Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",BMC public health,['10.1186/s12889-020-08910-3'] 3016,32456804,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652, a Reversible Fatty Acid Amide Hydrolase Inhibitor, in Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Phase I Study.","PURPOSE This study aimed to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of ASP3652, a peripherally acting inhibitor of peripheral fatty acid amide hydrolase (FAAH) after 30-, 100-, 300-, 600-, and 900-mg single and 100- and 300-mg BID multiple oral dose in Japanese patients. METHODS This was a randomized, double-blind, placebo-controlled, single and multiple oral dose Phase I study in healthy, nonelderly men and elderly men and women. The study consisted of 2 parts: in the single oral dose part, 40 healthy, nonelderly men were randomized to receive placebo or ASP3652; in the multiple oral dose part, 48 enrolled nonelderly men and elderly men and women were randomized to receive placebo or ASP3652. In both parts, the investigator judged whether the individuals were healthy based on the results of physical examinations and screening. The safety profile was assessed by examining adverse events, defined as any untoward medical occurrence in an individual administered the study drug and that did not necessarily have a causal relationship with the study treatment; clinical laboratory evaluations; vital signs; the Profile of Mood States scale; and standard 12-lead ECGs and 12-lead ECGs for QT assessment. Pharmacokinetic parameters were estimated using unchanged ASP3652 concentrations in plasma and urine. Pharmacodynamic parameters were estimated using FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations. Safety and tolerability profiles were compared with the placebo group. FINDINGS ASP3652 was rapidly absorbed to reach C max in a single dose and near steady-state at approximately 3 days after the start of multiple dosing. The C max and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg. There was no apparent accumulation based on C max and AUC 0-12 after multiple doses. Although no differences were found in C max or AUC 0-12 by age in men, C max and AUC 0-12 were slightly higher in elderly women than elderly men. FAAH activity was inhibited in a dose-dependent manner, and plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide increased in all dose groups after single and multiple doses of ASP3652. The incidence of adverse events after multiple doses, which ranged from 44.4% to 66.7%, was similar across all treatment groups, including the placebo group. IMPLICATIONS Single and multiple doses of ASP3652 were well tolerated and increased endogenous cannabinoids.",2020,The C max and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"['Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women', 'healthy, nonelderly men and elderly men and women', '48 enrolled nonelderly men and elderly men and women', '40 healthy, nonelderly men', 'elderly women than elderly men', 'Japanese patients']","['ASP3652', 'Placebo', 'placebo or ASP3652', 'placebo']","['FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations', 'FAAH activity', 'safety, tolerability, and pharmacokinetic and pharmacodynamic properties', 'Safety and tolerability profiles', 'plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'C max and AUC of ASP3652', 'incidence of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.131241,The C max and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. Electronic address: masaomi.takizawa@astellas.com.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hatta', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iitsuka', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroishi', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Yanagibashi-Clinical Trial Center, Yanagibashi Hospital, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.021'] 3017,32462607,Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO ® and OTEMTO ® Studies.,"INTRODUCTION The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted. METHODS TONADO ® 1&2 and OTEMTO ® 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg tiotropium (LAMA) or 5/5 µg tiotropium/olodaterol (LAMA/LABA). We assessed changes from baseline and responder rates for trough forced expiratory volume in 1 s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI). RESULTS Overall, 151 patients received tiotropium; 148 received tiotropium/olodaterol. Mean differences from baseline with tiotropium/olodaterol versus tiotropium were + 0.074 l (95% confidence interval [CI] 0.033, 0.115; P = 0.0004) for trough FEV 1 , - 2.675 (95% CI - 5.060, - 0.291; P = 0.0280) for SGRQ and 1.148 (95% CI 0.564, 1.732; P = 0.0001) for TDI. Patients were more likely to respond when treated with tiotropium/olodaterol versus tiotropium for trough FEV 1 (odds ratio [OR] 3.14, 95% CI 1.94, 5.06; P < 0.0001), SGRQ (OR 1.49, 95% CI 0.93, 2.40; P = 0.0980) and TDI (OR 2.81, 95% CI 1.71, 4.60; P < 0.0001). Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). CONCLUSION In patients with COPD receiving only LAMA monotherapy, treatment escalation to tiotropium/olodaterol resulted in statistically significant and clinically relevant improvements in lung function, health status and breathlessness. These results support early therapy optimisation to dual bronchodilation with tiotropium/olodaterol in patients receiving tiotropium alone. TRIAL REGISTRATION TONADO ® 1 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431274). TONADO ® 2 was registered in the US National Library of Medicine on 9 September 2011 (Clinicaltrials.gov: NCT01431287). OTEMTO ® 1 was registered in the US National Library of Medicine on 17 October 2013 (Clinicaltrials.gov: NCT01964352). OTEMTO ® 2 was registered in the US National Library of Medicine on 10 December 2013 (Clinicaltrials.gov: NCT02006732).",2020,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). ","['® 2 was registered in the US National Library of Medicine on 10 December 2013', 'patients with COPD receiving only', 'Patients with COPD Receiving only LAMA at Baseline', 'patients receiving tiotropium alone', '® 1 was registered in the US National Library of Medicine on 17 October 2013', 'patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD', 'chronic obstructive pulmonary disease (COPD']","['tiotropium (LAMA) or 5/5\xa0µg tiotropium/olodaterol (LAMA/LABA', 'Tiotropium/Olodaterol', 'muscarinic antagonists (LAMA) or long-acting β 2 -agonists (LABA', 'tiotropium/olodaterol', 'LAMA monotherapy', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['SGRQ', 'lung function, health status and breathlessness', ""trough forced expiratory volume in 1\xa0s (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) and the Transition Dyspnoea Index (TDI""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}]",,0.511381,"Minimum clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 l, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) was more likely in patients treated with tiotropium/olodaterol versus tiotropium (OR 2.43, 95% CI 1.32, 4.51; P = 0.0046). ","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01373-3'] 3018,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome. METHODS Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention. RESULTS Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself. LIMITATIONS The mean level of procrastination in this study was lower than in other treatment studies of procrastination. CONCLUSIONS Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579'] 3019,32460116,The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial.,"OBJECTIVES Today all pregnant women are recommended to participate in moderate intensity aerobic and resistance-based physical activity/exercise ≥150 min/week. However, there are still controversies and scant knowledge on the role of regular exercise on delivery outcomes, including mode of delivery and length of active labour. In addition, nutritional counselling have often been examined together with exercise, which may independently effect the outcomes. Hence, the aims of the present study were to investigate the sole effect of supervised group exercise, including pelvic floor muscle training on course of labour and mode of delivery. STUDY DESIGN A single blind, randomized controlled trial, performed in the municipality of Oslo, Norway. Out of 105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7 ± 4.2) to study the effect regular aerobic exercise (60 min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7 ± 1.7) on labour outcomes (exercise: 43 and control: 47). Data were collected via standardized interviews and birth partographs from hospital records, reported on the postpartum visit (weeks after labour 7.6 ± 1.6). The primary investigator was unaware of the original randomization at the time of the interviews. The principal analysis was done on an intention to treat basis (ITT). For the planned subgroup analyses (per protocol), acceptable intervention adherence was defined as attending ≥ 80% of the recommended exercise program (≥ 19 exercise sessions). RESULTS There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT. Per protocol analyses, showed a shorter duration of total active labour in the exercise group (6.8 ± 5.5 h) than the control group (9.8 ± 5.4 h), with a mean between group difference of 3.1 h (95% CI 0.31-5.9, p = 0.029). Rate of normal vaginal delivery was 85.7% among adherent participants and 62.3% in the control group (p = 0.051). CONCLUSIONS Regular exercise during pregnancy decreased duration of total active labour and showed a trend towards more normal vaginal deliveries among participants who adhered to the prescribed program. TRIAL REGISTRATION ClinicalTrials.gov: NCT00617149.",2020,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","['60\u2009min 2/week) on health benefits for both mother and her baby, 90 (85.7%) completed postpartum follow-up (7.7\u2009±\u20091.7) on labour outcomes (exercise: 43 and control: 47', 'Today all pregnant women', '105 healthy, inactive nulliparous women, initially enrolled (gestation week 17.7\u2009±\u20094.2) to study the effect', 'municipality of Oslo, Norway']","['regular exercise training', 'Regular exercise', 'regular aerobic exercise', 'supervised group exercise, including pelvic floor muscle training']","['normal vaginal deliveries', 'duration of total active labour', 'shorter duration of total active labour', 'Rate of normal vaginal delivery', 'induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT', 'acceptable intervention adherence']","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",105.0,0.114603,"There were no differences between the exercise and control groups in induction of labour, use of analgesia, duration of active labour or prolonged labour, according to ITT.","[{'ForeName': 'Lene A H', 'Initials': 'LAH', 'LastName': 'Haakstad', 'Affiliation': 'Associate Professor, Exercise Scientist, Norwegian School of Sports Sciences, Department of Sports Medicine, PO Box 4014, Ullevål Stadion, Oslo, Norway. Electronic address: lahaakstad@nih.no.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Bø', 'Affiliation': 'Professor, Exercise Scientist, Physical Therapist, Norwegian School of Sports Sciences, Department of Sports Medicine, Norway. Electronic address: kari.bo@nih.no.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.014'] 3020,32460138,Social timing influences sleep quality in patients with sleep disorders.,"OBJECTIVES We aimed to compare three variants of the Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ) and to assess whether chronotype (MSF sc )/social jetlag (SJL) are associated with sleep quality in patients with sleep disorders (SD). METHODS In sum, 431 SD patients and 338 subjects from the general population (GP) were included. Participants filled in three variants of the PSQI and the Munich ChronoType Questionnaire (MCTQ). We used Generalized Estimating Equations (GEE) to investigate effects of group (GP, SD), PSQI (usual, work or free) and their interaction (group∗PSQI) on scores. To investigate associations between MSF sc /SJL and the difference between PSQI w and PSQI f (PSQI diff ) in patients with SD we used linear regressions (N = 352). We used Sobel to test whether there was a mediation effect of SJL on the association between MSF sc and PSQI diff . RESULTS PSQI scores differed between groups (p < 0.001). Post-hoc analysis revealed a significant difference between PSQI u vs. PSQI f and PSQI w vs. PSQI f with PSQI f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group. In line with previous findings, SJL was associated to PSQI diff in SD patients. CONCLUSIONS PSQI u mainly represents sleep quality on workdays also in SD patients. Being a late chronotype seems to be associated with higher differences in sleep quality on work-vs. free days mostly when it coincides with societal time constraints. Since sleep quality is poorer on workdays even in SD patients, we suggest that treatment strategies should address social aspects affecting sleep, including ways of minimizing SJL.",2020,"f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group.","['patients with sleep disorders (SD', 'patients with SD', 'patients with sleep disorders', '431 SD patients and 338 subjects from the general population (GP) were included', 'SD patients']","['chronotype (MSF sc )/social jetlag (SJL', 'MSF sc /SJL', 'PSQI', 'SJL']","['PSQI (usual, work or free) and their interaction (group∗PSQI) on scores', 'PSQI u vs. PSQI f and PSQI w vs. PSQI', 'Pittsburgh Sleep Quality Index (PSQI usual, work- and work-free days: PSQI u , PSQI w , PSQI f ', 'PSQI scores', 'Munich ChronoType Questionnaire (MCTQ', 'sleep quality', 'PSQI w and PSQI f (PSQI diff ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231311', 'cui_str': 'Jet lag'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0284205,"f presenting lower scores, while PSQI u vs. PSQI w did not differ in any group.","[{'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Reis', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; IMM - Faculty of Medicine João Lobo Antunes, University of Lisbon, Portugal.'}, {'ForeName': 'Luísa K', 'Initials': 'LK', 'LastName': 'Pilz', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Laboratório de Cronobiologia e Sono, HCPA/UFRGS, Porto Alegre, RS, Brazil; PPG em Psiquiatria e Ciências do Comportamento, UFRGS, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Lena Katharina', 'Initials': 'LK', 'LastName': 'Keller', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany; Department of Child and Adolescent Psychiatry, University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paiva', 'Affiliation': 'CENC - Centro de Medicina de Sono, Lisbon, Portugal; ISAMB - Faculty of Medicine, University of Lisbon, Portugal; CHRC - Nova Medical School - Faculdade de Ciências Médicas, Lisbon, Portugal.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Roenneberg', 'Affiliation': 'Institute of Medical Psychology, Center for Chronobiology, Medical Faculty, LMU, Munich, Germany. Electronic address: roenneberg@lmu.de.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.019'] 3021,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary. OBJECTIVE To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning. METHODS A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied. RESULTS Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months. CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929'] 3022,32466190,The Effect of Physical Activity and High Body Mass Index on Health-Related Quality of Life in Individuals with Metabolic Syndrome.,"The main objective of this study was to examine the relationship between the level of physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL) in individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study. A total of 6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers. Subjects were classified according to categories of body mass index (BMI). PA was measured with the validated Registre Gironí del Cor (REGICOR) questionnaire and subjects were classified according to their PA level (light, moderate, vigorous) and the HRQoL was measured with the validated short-form 36 (SF-36) questionnaire. By using the ANOVA model, we found a positive and statistically significant association between the level of PA and the HRQoL (aggregated physical and mental dimensions p < 0.001), but a negative association with higher BMI in aggregated physical dimensions p < 0.001. Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36. Therefore, it is essential to promote PA and body weight control from primary care consultations to improve HRQoL, paying special attention to the differences that sex incurs.",2020,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","['6875 subjects between 55 and 75 years of age with MetS were selected and randomized in 23 Spanish centers', 'Individuals with Metabolic Syndrome', 'individuals with metabolic syndrome (MetS) who participated in the Predimed-Plus study']",['Physical Activity and High Body Mass Index'],"['level of PA and the HRQoL', 'physical activity (PA) and the degree of obesity with health-related quality of life (HRQoL']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",6875.0,0.0214871,"Furthermore, women obtained lower scores compared with men, more five points in all fields of SF-36.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Marcos-Delgado', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Fernández-Villa', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ángel M', 'Initials': 'ÁM', 'LastName': 'Alonso-Gómez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vioque', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'J LLuís', 'Initials': 'JL', 'LastName': 'Serra-Majem', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Molina', 'Affiliation': 'CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Josep A', 'Initials': 'JA', 'LastName': 'Tur', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodríguez', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Matía-Martín', 'Affiliation': 'Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), 28040 Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': 'CIBER Diabetes y Enfermedades Metabólicas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), 28029 Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, 28049 Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Babio', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ignacio M', 'Initials': 'IM', 'LastName': 'Gimenez-Alba', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Zulet', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vaquero-Luna', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pérez-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pastor-Morel', 'Affiliation': 'Centro de Salud Cabo Huertas, 03540 Alicante, Spain.'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Galmes-Panades', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Rios', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'María Rosa', 'Initials': 'MR', 'LastName': 'Bernal-López', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Becerra-Tomás', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorin', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Zenaida', 'Initials': 'Z', 'LastName': 'Vázquez-Ruiz', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Abete', 'Affiliation': 'Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sorto-Sánchez', 'Affiliation': 'Bioaraba Health Research Institute, Cardiovascular, Respiratory and Metabolic Area, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, 48940 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Palau-Galindo', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Galilea-Zabalza', 'Affiliation': 'Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Institute of Health Carlos III, 28040 Madrid, Spain.'}, {'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Muñoz-Martínez', 'Affiliation': ""Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d'Investigació Médica (IMIM), 08003 Barcelona, Spain.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martín', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, 24071 León, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103728'] 3023,32446158,Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.,"BACKGROUND Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms. METHOD Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder. MAIN RESULTS The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group. DISCUSSION AND CONCLUSION We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.",2020,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group. ","['panic disorder', 'patients with panic symptoms', 'Forty-one patients']","['mobile app-based interactive CBT', 'chatbot group (n\u202f=\u202f21) or control group', 'mobile app-based interactive cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'Mobile app-based interactive CBT']","['severity of panic symptoms', 'severity of panic disorder', 'control helplessness score', 'social phobia score']","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]",41.0,0.0195038,"The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group. ","[{'ForeName': 'Jooyoung', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sooah', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Jin', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jaejkim@yonsei.ac.kr.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104171'] 3024,32449418,The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris: a randomized controlled clinical trial.,"Background and objectives: Lichen planopilaris (LPP) is one of the important causes of cicatricial alopecia. We aimed to evaluate the efficacy and safety of low-dose naltrexone (LDN) in the setting of a clinical trial in patients with LPP. Methods: We included patients with LPP between 2018 and 2020. Patients were allocated to two groups. The first group received topical clobetasol plus oral low dose naltrexone (3 mg) while the second received topical clobetasol plus placebo. The assessment was made for the disease severity by lichen planopilaris activity index (LPPAI) instrument and the safety of the drug in 2-month intervals up to 6 months. To compare both groups, we used the ANOVA test for repeated measures. Clinical trials registry code: IRCT20180809040747N1. Results: Thirty-four patients were analyzed in an intention-to-treat fashion. There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN ( p  = .001) but almost significant within the placebo group ( p  = .060) and non-significant between the groups ( p  = .813). The side effects attributable to the low dose naltrexone was not statistically different between studied groups. Conclusion: Low-dose naltrexone (3 mg) failed to improve the severity of the LPP more than what is achievable with topical clobetasol.",2020,There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813).,"['patients with lichen planopilaris', 'patients with LPP', 'patients with LPP between 2018 and 2020']","['naltrexone', 'topical clobetasol plus placebo', 'Lichen planopilaris (LPP', 'low-dose naltrexone (LDN', 'topical clobetasol plus oral low dose naltrexone', 'oral low dose naltrexone', 'placebo']","['efficacy and safety', 'LPPAI scores', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",34.0,0.0910378,There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813).,"[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Lajevardi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Salarvand', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghiasi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Department of Dermatology, Razi Dermatological Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Taraz', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1774488'] 3025,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown. METHODS In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36). RESULTS A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). CONCLUSIONS In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). ","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008). ","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883'] 3026,32447224,Shorter sleep duration is associated with lower GABA levels in the anterior cingulate cortex.,"BACKGROUND Alterations in the levels of gamma-aminobutyric acid (GABA) and glutamate + glutamine (Glx), which are major inhibitory and excitatory neurotransmitters, respectively, are frequently associated with insomnia. Previous reports also suggested the involvement of the anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration. In the current study, we investigated whether the GABA and Glx levels were altered in the ACC/mPFC in subclinical insomnia while focusing on the sleep duration. METHODS We examined levels of GABA and Glx in the ACC/mPFC of the brain with magnetic resonance spectroscopy in 166 individuals with subjective sleep complaints but without a diagnosis of insomnia. Participants were divided into two groups according to sleep duration (≥6 h/night: n = 79 vs. < 6 h/night: n = 74), which was measured using a wrist-worn actigraphy. Working memory function and overall subjective sleep quality were assessed with a computerized neuropsychological test and self-report questionnaire, respectively. RESULTS GABA levels in the ACC/mPFC were lower in the shorter sleep duration group relative to the longer sleep duration group (t = -2.21, p = 0.03). Glx levels did not differ between the two groups (t = -0.20, p = 0.84). Lower GABA levels were associated with lower spatial working memory performance in the shorter sleep duration group (β = -0.21, p = 0.03), but not the longer sleep duration group (β = 0.04, p = 0.72). CONCLUSION Shorter sleep duration was associated with lower GABA levels in the ACC/mPFC. These findings may provide insight into the underlying mechanisms of impaired working memory function related to insomnia and sleep loss.",2020,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).",['166 individuals with subjective sleep complaints but without a diagnosis of insomnia'],['magnetic resonance spectroscopy'],"['Shorter sleep duration', 'anterior cingulate cortex (ACC) and medial prefrontal cortex (mPFC) in insomnia and shorter sleep duration', 'Glx levels', 'mPFC', 'Working memory function and overall subjective sleep quality', 'GABA levels', 'GABA and Glx levels', 'Lower GABA levels', 'spatial working memory performance']","[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",166.0,0.0321215,"Glx levels did not differ between the two groups (t = -0.20, p = 0.84).","[{'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Ilhyang', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russell H. Morgan Department of Radiology and Radiological Science, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; F.M. Kirby Research Center for Functional Brain Imaging, Kennedy Krieger Institute, Baltimore, MD, USA.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jinsol', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: jungyoon.kimm@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.018'] 3027,32449083,Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Heart Failure Events in Patients with Type 2 Diabetes Mellitus: A Cost Per Outcome Analysis.,"BACKGROUND AND OBJECTIVE Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have significant efficacy in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) mortality in patients with type 2 diabetes mellitus (T2DM). However, there are differences in HF outcomes between the SGLT2i. Therefore, we compared the cost needed to achieve these outcomes between empagliflozin, canagliflozin, and dapagliflozin. METHODS We calculated the cost needed to treat (CNT) in order to prevent one event of hHF or CV mortality, by multiplying the annualized number needed to treat (NNT) to prevent one event, by the annual cost of each therapy. Efficacy estimates were extracted from published randomized controlled trial (RCT) data. A sensitivity analysis was performed to mitigate differences between the RCT populations. Drug costs were extracted from the 2020 US National Average Drug Acquisition Cost listing. RESULTS We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin. The sensitivity analysis confirmed the cost advantage of empagliflozin. CONCLUSIONS Our findings suggest that empagliflozin prescribed for preventing CV death or hHF in T2DM patients seems to be cost saving compared to treatment with canagliflozin, and dapagliflozin.",2020,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Sodium-glucose cotransporter 2 inhibitors (SGLT2i', 'empagliflozin', 'empagliflozin, canagliflozin, and dapagliflozin', 'Sodium-Glucose Cotransporter 2 Inhibitors']","['HF outcomes', 'cardiovascular (CV) mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.173062,"We figured empagliflozin's CNT to be $664,464 (95% CI $499,872-$1,097,280), $1,535,387 (95% CI $886,074-$3,210,501) for canagliflozin, and $2,693,145 (95% CI $1,639,563-$11,092,206) for dapagliflozin.","[{'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Arbel', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel. ronen.arbel@gmail.com.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Aboalhasan', 'Affiliation': 'Maximizing Health Outcomes Research Lab, Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon, 79165, Sderot, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Hammerman', 'Affiliation': 'Department of Pharmaceutical Technology Assessment, Clalit Health Services Headquarters, Tel-Aviv, Israel.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Azuri', 'Affiliation': 'Diabetes Clinic, Central District, Maccabi Healthcare Services, Tel Aviv, Israel.'}]",Clinical drug investigation,['10.1007/s40261-020-00929-z'] 3028,32453167,Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial.,"BACKGROUND For endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) under general anaesthesia, both rigid bronchoscopy and laryngeal masks (LMAs) with superimposed high-frequency jet ventilation can be used. Despite the fact that in Europe rigid bronchoscopy for EBUS-TBNA is still widely used, an increasing number of centres use jet ventilation via the LMA for this procedure. To our knowledge no clinical trials have ever been made to compare these two methods. This trial aimed to evaluate whether patients recover from the procedure more quickly when a LMA is used for ventilation compared with rigid bronchoscopy where muscle relaxants and deep anaesthesia are required. OBJECTIVES We wanted to test the hypothesis that there is no difference in the postoperative recovery of patients in the postanaesthesia care unit (PACU) after EBUS-TBNA with jet ventilation via a rigid bronchoscope and a LMA. Secondary outcomes were the difference of duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups. DESIGN Prospective randomised single blinded two centre controlled trial. SETTING Two centres in Austria participated. Patients were enrolled from December 2016 until January 2018. PATIENTS Ninety patients for elective EBUS-TBNA were enrolled and assigned to one of two intervention groups. Two patients were excluded before and eleven patients were excluded after EBUS-TBNA. Seventy-seven were analysed. INTERVENTIONS Patients assigned to group 1 were ventilated with a LMA; those assigned to group 2 were ventilated via a rigid bronchoscope. Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU were recorded. MAIN OUTCOME MEASURES The primary endpoint was an integral over time of a modified Aldrete score. Secondary endpoints were the durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome. RESULTS We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes. Vital signs remained stable and in an equal range in both groups. There were no differences in the mean effect site propofol concentration and the peak ultiva rates. CONCLUSION EBUS-TBNA under general anaesthesia using a LMA with SHJV is equal to rigid bronchoscopy with superimposed high-frequency jet ventilation for the variables analysed. TRIAL REGISTRATION ISRCTN (ISRCTN58911367).",2020,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","['Patients were enrolled from December 2016 until January 2018', 'Seventy-seven were analysed', 'Ninety patients for elective EBUS-TBNA', 'Two patients were excluded before and eleven patients were excluded after EBUS-TBNA', 'Two centres in Austria participated']","['ventilated via a rigid bronchoscope', 'endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'LMA with SHJV', 'endobronchial ultrasound-guided transbronchial needle aspiration', 'Infraglottic versus supraglottic jet-ventilation', 'LMA']","['Vital signs, drug dosage, duration of anaesthesia, recovery, PACU stay and Aldrete score at the PACU', 'mean effect site propofol concentration and the peak ultiva rates', 'integral over time of a modified Aldrete score', 'durations of the interventions, the recovery from anaesthesia and PACU stay, initial and mean Aldrete values at PACU, the effect site concentration of Propofol according to the Schnider pharmacokinetic model, the peak ultiva rates and the diagnostic outcome', 'duration of anaesthesia, the diagnostic outcome of the procedure and drug quantities for both groups']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1821424', 'cui_str': 'Post Anesthetic Recovery score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0594510', 'cui_str': 'Ultiva'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",2.0,0.127212,"We were not able to show any significant difference regarding the postoperative recovery criteria based on the Aldrete score, the durations measured and the diagnostic outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anwar', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fritze', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Base', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wasserscheid', 'Affiliation': ''}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Wolfram', 'Affiliation': ''}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Koinig', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hackner', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lambers', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schweiger', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Errhalt', 'Affiliation': ''}, {'ForeName': 'Mir A', 'Initials': 'MA', 'LastName': 'Hoda', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001220'] 3029,32453168,Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial.,"BACKGROUND Ultrasound has increased the efficacy of femoral nerve catheters but their postoperative dislocation still remains a common problem. Although catheter placement parallel to the nerve seems to reduce dislocation rates in other nerves and plexuses, the possible advantage for femoral nerve catheter placement remains unclear. OBJECTIVE To compare the dislocation rates of femoral catheters when placed perpendicular or parallel to the femoral nerve. DESIGN Randomised controlled study. SETTING University orthopaedic hospital. Duration of study: October 2018 to June 2019. PATIENTS Eighty patients scheduled for major knee surgery with femoral catheter were enrolled and randomly allocated in two groups. Data from 78 patients could be analysed. INTERVENTIONS The femoral nerve catheters was placed perpendicular to the nerve in Group 1 (n=40), whereas in Group 2 (n=38) parallel to it. For Group 1 the short-axis view of the nerve and an in-plane puncture was used. For Group 2 we used the short-axis view of the nerve and an out-of-plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane. MAIN OUTCOME MEASURES Primary outcome was the catheter dislocation rate in the first 48 h. Secondary outcomes were pain scores and sensory blockade. RESULTS There was no statistically significant difference between the two techniques regarding dislocation of the catheters at 24 or 48 h (at 48 h, Group 1: 15%, Group 2: 2.6%, P = 0.109). Also pain scores, sensory blockade and rescue doses of ropivacaine did not differ between the groups. However, in Group 2 the technique took longer. CONCLUSION Rotating the ultrasound probe to the long-axis in-plane view enabled examination of the catheter position when it was placed parallel to the nerve. The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT03693755.",2020,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade. ","['University orthopaedic hospital', '78 patients could be analysed', 'Eighty patients scheduled for major knee surgery with femoral catheter', 'Duration of study: October 2018 to June 2019']","['perineural catheters placed either perpendicular or parallel to the femoral nerve', 'ropivacaine', 'plane puncture technique combined with rotation of the transducer to the long-axis view with the needle in-plane']","['Dislocation rates', 'dislocation of the catheters', 'pain scores and sensory blockade', 'catheter dislocation rate', 'dislocation rates', 'pain scores, sensory blockade and rescue doses', 'dislocation rate, pain scores or sensory blockade', 'dislocation rates of femoral catheters']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",80.0,0.154648,"The parallel placement of the catheter required more time, but did not significantly improve dislocation rate, pain scores or sensory blockade. ","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kalimeris', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rupnik', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Allenspach', 'Affiliation': ''}, {'ForeName': 'Sandro F', 'Initials': 'SF', 'LastName': 'Fucentese', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Götschi', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Aguirre', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Eichenberger', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001237'] 3030,32450083,Randomized matrix games in a finite population: Effect of stochastic fluctuations in the payoffs on the evolution of cooperation.,"A diffusion approximation for a randomized 2 × 2-matrix game in a large finite population is ascertained in the case of random payoffs whose expected values, variances and covariances are of order given by the inverse of the population size N. Applying the approximation to a Randomized Prisoner's Dilemma (RPD) with independent payoffs for cooperation and defection in random pairwise interactions, conditions on the variances of the payoffs for selection to favor the evolution of cooperation, favor more the evolution of cooperation than the evolution of defection, and disfavor the evolution of defection are deduced. All these are obtained from probabilities of ultimate fixation of a single mutant. It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection. A RPD game with independent payoffs whose expected values are additive is studied in detail to support the conclusions. Randomized matrix games with non-independent payoffs, namely the RPD game with additive payoffs for cooperation and defection based on random cost and benefit for cooperation and the repeated RPD game with Tit-for-Tat and Always-Defect as strategies in pairwise interactions with a random number of rounds, are studied under the assumption that the population-scaled expected values, variances and covariances of the payoffs are all of the same small enough order. In the first model, the conditions in favor of the evolution of cooperation hold only if the covariance between the cost and the benefit is large enough, while the analysis of the second model extends the results on the effects of the variances of the payoffs for cooperation and defection found for the one-round RPD game.",2020,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,[],[],[],[],[],[],,0.0254081,It is shown that the conditions are lessened with an increase in the variances of the payoffs for defection against cooperation and defection and a decrease in the variances of the payoffs for cooperation against cooperation and defection.,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': 'Département de mathématiques et de statistique, Université de Montréal, Montréal, Québec, H3C 3J7, Canada. Electronic address: lessards@dms.umontreal.ca.'}]",Theoretical population biology,['10.1016/j.tpb.2020.04.006'] 3031,32452561,Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding.,"BACKGROUND Early-transjugular intrahepatic porto-systemic shunt (TIPSS) has been recommended in international guidelines for high-risk patients with oesophageal variceal bleeding. AIM To validate the results of a previous randomised control trial which supports use of early-TIPSS. METHODS In a two-centre open-label parallel-group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso-active drugs and endoscopic band ligation. Participants were randomised to standard of care or early-TIPSS. The primary outcome was 1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension. RESULTS Fifty-eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early-TIPSS group, a 1-year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early-TIPSS group (P = 0.09). Not all participants randomised to early-TIPSS received the intervention in time. For those receiving TIPSS per-protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05). CONCLUSIONS Early-TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high-risk patients with oesophageal variceal bleeding. Early-TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.",2020,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05). ","['high-risk patients with oesophageal variceal bleeding', 'Fifty-eight patients (58\xa0±\xa011.12\xa0years; 32.7% female', 'patients with cirrhosis and acute variceal bleeding were recruited following', 'patients with cirrhosis and oesophageal variceal bleeding']","['transjugular intrahepatic porto-systemic shunt (TIPSS', 'standard of care or early-TIPSS', 'care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS', 'haemostasis with vaso-active drugs and endoscopic band ligation']","['Variceal rebleeding', 'rates of hepatic encephalopathy', 'Serious adverse events', 'survival', 'variceal rebleeding, increased encephalopathy', 'variceal rebleeding rates', '1-year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension', '1-year survival']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]","[{'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]",58.0,0.414712,"Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05). ","[{'ForeName': 'Philip D J', 'Initials': 'PDJ', 'LastName': 'Dunne', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Lachlan', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Ireland', 'Affiliation': 'Department of Radiology, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Shams', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kasthuri', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Ewan H', 'Initials': 'EH', 'LastName': 'Forrest', 'Affiliation': 'Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hayes', 'Affiliation': 'Liver Unit, Royal Infirmary of Edinburgh and University of Edinburgh, Edinburgh, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15797'] 3032,32459322,Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial.,"Importance Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications. Objective To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA. Design, Setting, and Participants In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol. Interventions Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA. Main Outcomes and Measures The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution. Results Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%). Conclusions and Relevance This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings. Trial Registration German Clinical Trials Register: DRKS00007784.",2020,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","['June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy', '248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years', 'pain control after pancreatic surgery', 'n\u2009=\u2009186); 248 patients (124 in each group) were analyzed']","['Pancreatoduodenectomy', 'Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA', 'EDA', 'Epidural vs Patient-Controlled Intravenous Analgesia', 'PCIA and EDA', 'general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device', 'PCIA']","['gastrointestinal complications', '30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids', '30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution', 'composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus', 'Gastrointestinal Complications', 'Failure of EDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]",,0.168465,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Klotz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klose', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Tenckhoff', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lock', 'Affiliation': 'Department of General, Visceral, Transplant, Vascular and Paediatric Surgery, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Elmar-Marc', 'Initials': 'EM', 'LastName': 'Brede', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Surgical and Oncological Department, Pancreas Institute, University Hospital Trust, Verona, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Polati', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Verona University Hospital, Verona, Italy.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Köninger', 'Affiliation': 'Department of General, Visceral, Thorax and Transplantation Surgery, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Jan-Henrik', 'Initials': 'JH', 'LastName': 'Schiff', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Uwe A', 'Initials': 'UA', 'LastName': 'Wittel', 'Affiliation': 'Department of General and Visceral Surgery, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hötzel', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Keck', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anca-Laura', 'Initials': 'AL', 'LastName': 'Amati', 'Affiliation': 'Department of Visceral, Thoracic, Transplant and Paediatric Surgery, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eberl', 'Affiliation': 'Department of Surgery, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zink', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Tomazic', 'Affiliation': 'Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Novak-Jankovic', 'Affiliation': 'Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hofer', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.0794'] 3033,32459348,Effectiveness of a Guided Web-Based Self-help Intervention to Prevent Depression in Patients With Persistent Back Pain: The PROD-BP Randomized Clinical Trial.,"Importance Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden. Objective To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain. Design, Setting, and Participants Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019. Interventions The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual. Main Outcomes and Measures Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments. Results A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001). Twenty-one participants (14.1%) in the intervention group and 41 participants (28.1%) in the control group experienced an MDE over the 12-month period. The number needed to treat to prevent 1 new case of MDE was 2.84 (95% CI, 1.79-9.44). Conclusions and Relevance Results of this trial showed that among patients with persistent back pain, depression can be prevented by a guided web-based self-help intervention in addition to treatment as usual. This finding suggests that using a scalable digital approach to integrate psychological treatment into routine pain management is feasible. Trial Registration German Clinical Trials Register Identifier: DRKS00007960.",2020,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","['Patients With Persistent Back Pain', 'patients with persistent back pain', '295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4', 'Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017', 'Back Pain Patients (PROD-BP']","['web-based self-help intervention', 'e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy', 'Guided Web-Based Self-help Intervention']","['time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5', 'incidence of major depressive episode (MDE', 'MDE', 'risk of MDE onset', 'depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",295.0,0.196853,"The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P < .001).","[{'ForeName': 'Lasse B', 'Initials': 'LB', 'LastName': 'Sander', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Paganini', 'Affiliation': 'Institute for Sports and Sport Science, Department of Sports Psychology, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Institute of Psychology and Education, Department of Research Methods, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Jiaxi', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Medical Center, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Spanhel', 'Affiliation': 'Institute of Psychology, Department of Rehabilitation Psychology and Psychotherapy, Albert-Ludwigs-University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Institute of Psychology, Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Vrije University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Institute of Psychology and Education, Department of Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1021'] 3034,32455853,Low-Intensity Physical Exercise Improves Pain Catastrophizing and Other Psychological and Physical Aspects in Women with Fibromyalgia: A Randomized Controlled Trial.,"Fibromyalgia (FM) is a chronic syndrome characterized by widespread pain and other physical and psychological features. In this study, we aimed to analyze the effect of a low-intensity physical exercise (PE) program, combining endurance training and coordination, on psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity) in women with FM. For this purpose, a randomized controlled trial was carried out. Thirty-two women with FM were randomly allocated to a PE group (PEG, n = 16), performing an eight-week low-intensity PE program and a control group (CG, n = 16). Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity were assessed before and after the intervention. We observed a significant improvement in all studied variables in the PEG after the intervention ( p < 0.05). In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p < 0.05). In conclusion, a low-intensity combined PE program, including endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning in women with FM.",2020,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p < 0.05).","['Women with Fibromyalgia', 'Thirty-two women with FM', 'women with FM']","['low-intensity physical exercise (PE) program, combining endurance training and coordination', 'Low-Intensity Physical Exercise', 'PE group (PEG, n = 16), performing an eight-week low-intensity PE program']","['psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity', 'Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity', 'endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",32.0,0.0914066,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p < 0.05).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Izquierdo-Alventosa', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Freshage Research Group, Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cortés-Amador', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Gimeno-Mallench', 'Affiliation': 'Freshage Research Group, Department of Physiology, Faculty of Medicine, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Chirivella-Garrido', 'Affiliation': 'Fundación Fivan, Centro de Neurorehabilitación, 46005 Valencia, Spain.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Kropotov', 'Affiliation': 'N.P. Bechtereva Institute of Human Brain, Russian Academy of Science, 197022 St. Petersburg, Russia.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103634'] 3035,32456250,Effects of the Use of Air Purifier on Indoor Environment and Respiratory System among Healthy Adults.,"Air purifiers have become popular among ordinary families. However, it remains controversial whether indoor air purification improves the respiratory health of healthy adults. A randomized crossover intervention study was conducted with 32 healthy individuals. The subjects were categorized into two groups. One group continuously used true air purifiers, and the other followed with sham air purifiers for 4 weeks. Following this first intervention, all the subjects underwent a 4-week washout period and continued with the second 4-week intervention with the alternate air purifiers. We collected fine particulate matter (PM) ≤ 2.5 µm in aerodynamic diameter (PM2.5), coarse particulate matter between 2.5 and 10 µm in aerodynamic diameter (PM10-2.5) and ozone (O 3 ). The subjects' pulmonary function and fractional exhaled nitric oxide (FeNO) were measured during the study period. The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers. However, this decrease was not significant ( p = 0.08). The air purification did not significantly improve the pulmonary function of the study subjects. In contrast, an increase in the indoor PM10-2.5 and O 3 concentration led to a significant decrease in the forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF), respectively. In conclusion, air purification slightly improved the indoor PM2.5 concentrations in ordinary homes but had no demonstrable impact on improving health.",2020,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"['Healthy Adults', 'healthy adults', '32 healthy individuals']",['Air Purifier'],"['health', 'indoor PM2.5 concentrations', 'pulmonary function', 'Indoor Environment and Respiratory System', ""subjects' pulmonary function and fractional exhaled nitric oxide (FeNO"", 'forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0262774', 'cui_str': 'Air Purifier'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231985', 'cui_str': 'Mean maximum expiratory flow'}]",32.0,0.016093,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Yoda', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': ""Hyogo Regional Center of Japan Environment and Children's Study, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.""}, {'ForeName': 'Naruhito', 'Initials': 'N', 'LastName': 'Otani', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Shoji F', 'Initials': 'SF', 'LastName': 'Nakayama', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shima', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103687'] 3036,32457257,Feasibility of laparoscopic liver resection for liver cavernous hemangioma: A single-institutional comparative study.,"Backgrounds/Aims While minimal invasive surgery has become popular, the feasibility of laparoscopy for liver cavernous hemangioma has not been shown. Methods Patients who underwent hepatectomy for liver cavernous hemangioma from January 2008 to February 2019 at the Samsung Medical Center were reviewed. Patients who underwent trisectionectomy were excluded. Background characteristics, along with operative and postoperative recovery, were compared between the laparoscopy and open surgery groups. Results Forty-three patients in the laparoscopy group and 33 patients in the open surgery group were compared. The differences in the background characteristics were presence of symptoms (14.6% in laparoscopy vs. 57.1% in open, p <0.001) and tumor location (right, left and both side p =0.017). The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001, p =0.017 each). There was no significant difference in complication after surgery between two groups ( p =0.721). All the patients showed pathologic report of benign hemangioma regardless of type of surgery (100%). Almost every patients reported no symptom or relief of symptom in both groups (97.7%, 93.9% each). Conclusions Laparoscopic liver resection for liver cavernous hemangioma can be safely performed with improved postoperative recovery. However, surgery for liver cavernous hemangioma should be conducted with informed consent of the patients.",2020,"The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001, p =0.017 each).","['Methods\n\n\nPatients who underwent hepatectomy for liver cavernous hemangioma from January 2008 to February 2019 at the Samsung Medical Center were reviewed', 'liver cavernous hemangioma', 'Patients who underwent trisectionectomy were excluded']","['laparoscopy', 'laparoscopic liver resection']","['blood transfusion requirements', 'smaller blood loss', 'shorter hospital stay', 'earlier drain removal', 'lower level of post-operative total bilirubin, prothrombin time (INR', 'earlier soft diet start', 'shorter amount and duration of additional pain control', 'symptom or relief of symptom', 'complication']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0238246', 'cui_str': 'Hemangioma of liver'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0301569', 'cui_str': 'Soft diet'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0447011,"The laparoscopy group had smaller blood loss ( p =0.001), lesser blood transfusion requirements ( p =0.035), lower level of post-operative total bilirubin, prothrombin time (INR) ( p =0.001, 0.003 each), shorter hospital stay ( p =0.001), earlier soft diet start ( p <0.001), earlier drain removal ( p <0.001) and shorter amount and duration of additional pain control ( p =0.001, p =0.017 each).","[{'ForeName': 'Younghuen', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jinsoo', 'Initials': 'J', 'LastName': 'Rhu', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gyu-Seong', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong Man', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae-Won', 'Initials': 'JW', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Choon Hyuck David', 'Initials': 'CHD', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Annals of hepato-biliary-pancreatic surgery,['10.14701/ahbps.2020.24.2.137'] 3037,32462947,Effects of transcranial direct current stimulation on cortex modulation by stimulation of the primary motor cortex and parietal cortex in humans.,"Aim of the study: Transcranial magnetic stimulation (TMS) is used to measure corticospinal excitability (CSE) from the primary motor cortex (M1) in humans through motor-evoked potentials (MEPs). The variability of CSE responses to transcranial direct current stimulation (tDCS) protocols is high and needs to be reproduced in the healthy population. The M1 and posterior parietal cortex (PPC) are anatomically and functionally connected and could play a role in understanding the variability in CSE responses. We tested the individual MEPs following a common cathodal (ctDCS) protocol over the M1 and PPC. Materials and methods: Twenty-eight healthy subjects were randomized for a ctDCS stimulation over the left M1 and PPC for 20 min on a separate days. The first dorsal interosseous muscle (FDI) contralateral stimulation of the left M1 was used as the resting motor threshold (RMT), while 15 single pulses 4-8 s apart at an intensity of 120% RMT were used to determine the baseline MEP amplitude and at T0, 5, 10, 20, 30, 40, 50, and 60 min after ctDCS stimulation in both sessions. Results: A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 ( p  = 0.046 at M1, p  = 0.010 at PPC). Conclusion: Our results suggested that PPC stimulation can modulate M1 excitability and PPC-M1 connectivity, but a significant effect is only observed immediately post ctDCS. The tDCS showed variability in response to the tDCS protocol is consistent with other non-invasive brain stimulation studies.",2020,"A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 (p = 0.046 at M1, p = 0.010 at PPC).","['Twenty-eight healthy subjects', 'humans']","['transcranial direct current stimulation (tDCS) protocols', 'Transcranial magnetic stimulation (TMS', 'transcranial direct current stimulation']","['M1 excitability and PPC-M1 connectivity', 'corticospinal excitability (CSE']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}]",28.0,0.0346981,"A 20 min duration of ctDCS stimulation significantly deceased the CSE only at T0 (p = 0.046 at M1, p = 0.010 at PPC).","[{'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Bashir', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Dowihi', 'Initials': 'D', 'LastName': 'Aisha', 'Affiliation': 'Neuroscience Center, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamza', 'Affiliation': 'Department of Electrical Engineering, National University of Computer and Emerging Sciences, Lahore, Pakistan.'}, {'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Al-Hussain', 'Affiliation': 'Division of Neurology, College of Medicine, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Woo-Kyoung', 'Initials': 'WK', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Hallym University College of Medicine, Anyang, South Korea.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1775594'] 3038,32469385,Survival Outcomes Associated With 3 Years vs 1 Year of Adjuvant Imatinib for Patients With High-Risk Gastrointestinal Stromal Tumors: An Analysis of a Randomized Clinical Trial After 10-Year Follow-up.,"Importance Adjuvant imatinib is associated with improved recurrence-free survival (RFS) when administered after surgery to patients with operable gastrointestinal stromal tumor (GIST), but its influence on overall survival (OS) has remained uncertain. Objective To evaluate the effect of adjuvant imatinib on OS of patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery. Design, Setting, and Participants In this open-label, randomized (1:1), multicenter phase 3 clinical trial conducted in Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008. Data for this follow-up analysis were analyzed from September to November, 2019. Interventions Imatinib 400 mg/d administered orally for either 12 months or 36 months after surgery. Main Outcomes And Measures The primary end point was RFS; the secondary objectives included OS and treatment safety. Results The intention-to-treat cohort consisted of 397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat Population. Five-year and 10-year RFS was 71.4% and 52.5%, respectively, in the 36-month group and 53.0% and 41.8% in the 12-month group (hazard ratio [HR], 0.66; 95% CI, 0.49-0.87; P = .003). In the 36-month group, 5-year OS and 10-year OS rates were 92.0% and 79.0%, respectively, and in the 12-month group 85.5% and 65.3% (HR, 0.55; 95% CI, 0.37-0.83; P = .004). The results were similar in the efficacy population, from which 15 patients who did not have GIST in central pathology review and 24 patients who had intra-abdominal metastases removed at surgery were excluded (36-month group, 10-year OS 81.6%; 12-month group, 66.8%; HR, 0.50; 95% CI, 0.32-0.80; P = .003). No new safety signals were detected. Conclusions and Relevance Three years of adjuvant imatinib is superior in efficacy compared with 1 year of imatinib. Approximately 50% of deaths may be avoided during the first 10 years of follow-up after surgery with longer adjuvant imatinib treatment. Trial Registration ClinicalTrials.gov Identifier: NCT00116935.",2020,"No new safety signals were detected. ","['Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008', 'patients with operable gastrointestinal stromal tumor (GIST', 'Patients With High-Risk Gastrointestinal Stromal Tumors', 'patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery', '397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat Population']",['adjuvant imatinib'],"['intra-abdominal metastases', '10-year RFS', '5-year OS and 10-year OS rates', 'recurrence-free survival (RFS', 'Survival Outcomes', 'overall survival (OS', 'RFS; the secondary objectives included OS and treatment safety']","[{'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0854198', 'cui_str': 'Metastases to abdominal cavity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",400.0,0.296023,"No new safety signals were detected. ","[{'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Oncology, Skåne University Hospital and Lund University, Lund, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sundby Hall', 'Affiliation': 'Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schütte', 'Affiliation': 'Schwerpunktpraxis Oncology/Hematology, Düsseldorf, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Department of Gastroenterology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Philipp J', 'Initials': 'PJ', 'LastName': 'Jost', 'Affiliation': 'Medical Department III, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Klinik für Onkologie und Hämatologie am Krankenhaus Nordwest, Frankfurt, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Sarcoma Center, West German Cancer Center, Essen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard-Domagk-Institute of Pathology, University of Münster, Münster, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Kallio', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Jaakkola', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': '4Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Alvegård', 'Affiliation': 'Department of Cancer Epidemiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2091'] 3039,32469414,Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease: A Qualitative Study.,"Importance Bone marrow transplant (BMT) is a potentially curative treatment for sickle cell disease (SCD). Patient and caregiver attitudes toward BMT for SCD and the willingness to accept risks of BMT vary, but these attitudes are not well understood. Objective To understand patient and caregiver perceptions of and attitudes toward BMT for SCD and decision-making about BMT. Design, Setting, and Participants Qualitative study of interview transcripts from a convenience sample. Transcripts were from adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities. Interview transcripts were used from the needs assessment phase to develop a patient-decision aid in 2013 to 2014 (group 1) and from the baseline point in 2015 to 2016 (group 2) of the parent trial, a randomized clinical trial of adults and caregivers of patients with SCD to evaluate the effectiveness of a patient decision aid. Main Outcomes and Measures Participant perspectives on decision-making regarding BMT for SCD. Results Fifty-seven transcripts from adults with SCD and 50 transcripts from caregivers of patients with SCD were included. Median (interquartile range [IQR]) age of adults with SCD was 34 (21-50) years in group 1 and 30 (23-38) years in group 2. The median (IQR) age of caregivers was 42.5 (31-52) years in group 1 and 41 (35-46.5) years in group 2. Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants. Bone marrow transplant was perceived as a treatment option associated with serious risks. Reported attitudes toward BMT occurred on a continuum ranging from unfavorable to favorable. Participants reported serious decisional dilemma regarding BMT for SCD. Most participants expressed interest in learning about BMT or curative treatments. Conclusions and Relevance This qualitative study found a continuum in attitudes toward BMT for SCD and highlights the complexity of decision-making in BMT for SCD. Patients and families with SCD expressed an interest in learning about BMT. Future prospective studies of patient decision-making regarding BMT, especially in the context of emerging curative and novel disease-modifying therapies for SCD, are warranted.",2020,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"['adults with SCD and 50 transcripts from caregivers of patients with SCD', 'sickle cell disease (SCD', 'adults with SCD and caregivers of patients with SCD recruited from national and regional SCD conferences, symposia, and sickle cell clinics in 2 cities', 'Sickle Cell Disease']",['Importance\n\n\nBone marrow transplant (BMT'],['decision-making regarding BMT for SCD'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",,0.0344463,Most transcripts from adults with SCD (75.0% in group 1 and 72.4% in group 2) and caregivers of patients with SCD (76.7% in group 1 and 85.0% in group 2) were from female participants.,"[{'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Deeksha', 'Initials': 'D', 'LastName': 'Katoch', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Sinha', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Social and Decision Sciences, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lakshmanan', 'Initials': 'L', 'LastName': 'Krishnamurti', 'Affiliation': 'Department of Pediatrics, Division of Hematology-Oncology-BMT, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6742'] 3040,32464489,"Effects of transcranial direct current stimulation using miniaturized devices vs sertraline for depression in Korea: A 6 week, multicenter, randomized, double blind, active-controlled study.","We compared the efficacy and safety of transcranial direct current stimulation (tDCS) vs. Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants. This was a multi-center, double blind, active controlled study with non-inferiority testing. Patients were randomly assigned to receive tDCS (n = 45) or Sertraline (n = 47). tDCS was administered in 30-min, 2 mA prefrontal stimulation sessions for 10 consecutive weekdays, followed by 2 treatments at 4 and 6 weeks. Sertraline was administered at a dose of 50 mg per day for 6 weeks. The primary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. Mean MADRS scores decreased by 14.58 ± 8.51 points in the tDCS group and 12.32 ± 8.56 points in the Sertraline group. There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539). Noninferiority of tDCS compared with Sertraline was not demonstrated. The mean difference between the Sertraline and tDCS group was -2.258 (95% confidence interval [CI], -5.795 to 1.27811), and the lower boundary of the CI was lower than the prespecified noninferiority margin of -3.56. There were no significant group differences in the rate of adverse events. In the present study, the noninferiority of tDCS to Sertraline for the treatment of depression was not found in this Korean population.",2020,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","['depression in Korea', 'Major Depressive Disorder (MDD) in South Korean participants']","['Sertraline', 'tDCS', 'transcranial direct current stimulation (tDCS) vs. Sertraline', 'transcranial direct current stimulation using miniaturized devices vs sertraline']","['efficacy and safety', 'change in the Montgomery-Asberg Depression Rating Scale (MADRS) score', 'Mean MADRS scores', 'rate of adverse events']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.365678,"There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539).","[{'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Won-Jung', 'Initials': 'WJ', 'LastName': 'Choi', 'Affiliation': 'Gangnam Yonsei Psychiatry Clinic, Seoul, South Korea; Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sejoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea; Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Borah', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Son', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Mind-neuromodulation Laboratory and Department of Psychiatry, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi, South Korea; Center for Digital Health, Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi, South Korea. Electronic address: EMPATHY@yuhs.ac.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.04.012'] 3041,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts. MAIN OUTCOME MEASURES 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). INTERPRETATION As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. FUNDING The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006'] 3042,32464566,"Efficacy of the computer simulation-based, interactive communication education program for nursing students.","BACKGROUND Simulation-based education using standardized patients or high fidelity patient simulators is resource-intensive and can be limited in its consistency and repeatability. Standardized, interactive, and effective computer simulation-based education programs that improve communication skills among nursing students are greatly needed. OBJECTIVES This study aimed to (1) compare the efficacy of a computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program on communication knowledge, learning self-efficacy, and communication efficacy at baseline and twice after the intervention (immediately after and two weeks after); and (2) assess the acceptability and satisfaction of the ComEd reported by the participants. DESIGN This study employed a mixed-method, randomized controlled design with repeated measures. METHODS Students were recruited from four nursing schools and randomly assigned to either the intervention or AC group. They received either the ComEd or AC program installed on a tablet PC or a desktop computer in the classrooms and completed a 15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale. In addition, six open-ended questions were used to help participants reflect on their learning experiences and explore their satisfaction with the programs. The Generalized Estimating Equation (GEE) model was the main model employed to examine the effects of the ComEd program over time in comparison with the AC program, and the content analysis method was used for qualitative data. RESULTS In total, 131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test. Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks. The ComEd program was well accepted by the participants. CONCLUSIONS The ComEd is a promising approach because it is highly accessible, consistent, and repeatable, and has positive learning effects.",2020,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","['131 nursing students (66 in ComEd and 65 in AC) completed the programs and 127 participated through the two-week follow-up test', 'nursing students', 'Students were recruited from four nursing schools']","['computer simulation-based, interactive communication education (ComEd) program and an attention control (AC) program', 'computer simulation-based, interactive communication education program']","['communication skills', 'communication knowledge, learning self-efficacy, and communication efficacy', 'acceptability and satisfaction', '15-item communication knowledge scale, 10-item learning self-efficacy scale, 22-item communication efficacy scale, and 14-item satisfaction scale']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}]","[{'cui': 'C0009609', 'cui_str': 'Models, Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",131.0,0.0254637,"Compared to the AC group, the ComEd group significantly improved communication knowledge, learning self-efficacy, and communication efficacy; these effects were maintained at two weeks.","[{'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea; College of Nursing & The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: hchoi20@snu.ac.kr.'}, {'ForeName': 'Ujin', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Dong-A University, Busan, Republic of Korea.'}]",Nurse education today,['10.1016/j.nedt.2020.104467'] 3043,32469893,Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial.,"INTRODUCTION Intramuscular electroporation (IM/EP) is a vaccine delivery technique that improves the immunogenicity of DNA vaccines. We evaluated the acceptability and tolerability of electroporation among healthy African study participants. METHODS Forty-five participants were administered a DNA vaccine (HIV-MAG) or placebo by electroporation at three visits occurring at four week-intervals. At the end of each visit, participants were asked to rate pain at four times: (1) when the device was placed on the skin and vaccine injected, before the electrical stimulation, (2) at the time of electrical stimulation and muscle contraction, and (3) at 10 minutes and (4) 30 minutes after the procedure was completed. For analyses, pain level was dichotomized as either ""acceptable"" (none/slight/uncomfortable) or ""too much"" (Intense, severe, and very severe) and examined over time using repeated measures models. Optional brief comments made by participants were summarized anecdotally. RESULTS All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure. Most (76%) reported pain levels as acceptable at every time point across all vaccination visits. The majority of ""unacceptable"" pain was reported at the time of electrical stimulation. The majority of the participants (97%) commented that they preferred electroporation to standard injection. CONCLUSION Repeated intramuscular electroporation for vaccine delivery was found to be acceptable and feasible among healthy African HIV vaccine trial participants. The majority of participants reported an acceptable pain level at all vaccination time points. Further investigation may be warranted into the value of EP to improve immunization outcomes. ClinicalTrials.gov NCT01496989.",2020,The majority of participants reported an acceptable pain level at all vaccination time points.,"['All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure', 'Forty-five participants', 'healthy African participants', 'healthy African study participants', 'healthy African HIV vaccine trial participants']","['DNA vaccine (HIV-MAG) or placebo', 'repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine', 'Intramuscular electroporation (IM/EP']","['Acceptability and tolerability', 'acceptability and tolerability of electroporation', 'pain level', 'rate pain', 'pain levels', 'acceptable pain level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0206691', 'cui_str': 'Electropermeabilisation'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",45.0,0.16596,The majority of participants reported an acceptable pain level at all vaccination time points.,"[{'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mpendo', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Gaudensia', 'Initials': 'G', 'LastName': 'Mutua', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanvubya', 'Affiliation': 'Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda.'}, {'ForeName': 'Omu', 'Initials': 'O', 'LastName': 'Anzala', 'Affiliation': 'Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Nyombayire', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Karita', 'Affiliation': 'Project San Francisco (PSF), Kigali, Rwanda.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'EMMES Corporation, Rockville, Maryland, United States of America.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Hannaman', 'Affiliation': 'Ichor Medical Systems, Inc., San Diego, California, United States of America.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Price', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Fast', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Priddy', 'Affiliation': 'International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.'}, {'ForeName': 'Huub C', 'Initials': 'HC', 'LastName': 'Gelderblom', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Hills', 'Affiliation': 'University of California at San Francisco, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0233151'] 3044,32469906,"Training intervention to improve hygiene practices in Islamic boarding school in Yogyakarta, Indonesia: A mixed-method study.","BACKGROUND The primary objective of this study was to determine the effect of a training intervention in overall improvement in students' (santris) knowledge, behavior, and outcome. METHODS A mixed-methods exploratory sequential design was applied. First, qualitative data were collected from three focus group discussions with 20 supervisors and one in-depth interview with school principal to explore current hygiene practices. The information was then used to develop training intervention using either video, poster, and leaflet. To measure the effect, a stepped wedge cluster design with pre- and post-test analyses was conducted. A total of 452 junior high school santris in one Islamic boarding school were non-randomly allocated to either three intervention groups. Outcome measures were knowledge, personal behavior, and room hygiene. Codes and categories were produced in the qualitative analysis, while paired t-tests and Wilcoxon rank tests test were used in the quantitative analysis. RESULTS The qualitative study identified poor practices on personal and room hygiene among the santris and proposed a training intervention. Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001). Room hygiene was significantly improved among boys and those who received leaflets. CONCLUSION Having developed a specific training materials, school-based hygiene training intervention improved knowledge and personal behavior. Its effect on room hygiene particularly for female santris needs further strengthening of the intervention in this Islamic boarding school setting.",2020,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","['Islamic boarding school in Yogyakarta, Indonesia', '452 junior high school santris in one Islamic boarding school']","['training intervention', 'Training intervention']","[""overall improvement in students' (santris) knowledge, behavior, and outcome"", 'knowledge and personal behavior', 'Room hygiene', 'knowledge, personal behavior, and room hygiene']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",452.0,0.0218919,"Overall, there was a significant increase in knowledge and personal behavior after the intervention (7.22 ± 1.34 pre-intervention to 7.70 ± 0.74 post-intervention and 9.75 ± 2.98 pre-intervention to 12.16 ± 2.12 post-intervention, respectively, p < 0.001).","[{'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Widyasari', 'Affiliation': 'International Health, Public Health Graduate Program, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yayi Suryo', 'Initials': 'YS', 'LastName': 'Prabandari', 'Affiliation': 'Department of Health Behavior, Environment, and Social Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Utarini', 'Affiliation': 'Department of Health Policy and Management, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",PloS one,['10.1371/journal.pone.0233267'] 3045,32276577,Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies.,"AIMS Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors consistently reduce low-density lipoprotein cholesterol (LDL-C) by 50-60% and lipoprotein(a) (Lp(a)) by 20-30%, but the mechanism of Lp(a) lowering remains unclear. If Lp(a) is cleared by the LDL receptor, similar to LDL-C, then one would expect PCSK9 inhibition to induce a concordant LDL-C/Lp(a) response in an approximately 2:1 ratio. We aim to determine the prevalence of discordant plasma LDL-C/Lp(a) response to the PCSK9 inhibitor alirocumab. METHODS This is a post hoc, pooled analysis of 10 randomized controlled trials from the ODYSSEY Phase 3 clinical trial program for alirocumab. Patients enrolled in the trials were high cardiovascular risk and/or with heterozygous familial hypercholesterolemia. The primary end point was prevalence of discordant LDL-C/Lp(a) response to alirocumab at 24 weeks. Discordant response was defined as LDL-C reduction >35% and Lp(a) reduction ≤10%, or LDL-C reduction ≤35% and Lp(a) reduction >10%. RESULTS Of the 1709 patients in the pooled study cohort, 62.4% were male, and the mean age was 59.2 (SD: 11.0) years. Baseline mean LDL-C was 126.5 (SD: 46.3) mg/dL and baseline median Lp(a) was 46.9 (interquartile range: 21.8-89.0) mg/dL. Total prevalence of discordant LDL-C/Lp(a) response was 21.5% (12.6% with LDL-C >35% reduction and Lp(a) ≤10% reduction; 8.9% with LDL-C ≤35% reduction and Lp(a) >10% reduction). Baseline Lp(a) and familial hypercholesterolemia status did not affect discordance. CONCLUSION A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.",2020,"A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.","['Patients enrolled in the trials were high cardiovascular risk and/or with heterozygous familial hypercholesterolemia', '1709 patients in the pooled study cohort, 62.4% were male, and the mean age was 59.2']","['alirocumab', 'Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors']","['Total prevalence of discordant LDL-C/Lp(a) response', 'prevalence of discordant LDL-C/Lp(a) response', 'Baseline Lp(a) and familial hypercholesterolemia status', 'Lp(a', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1709.0,0.0845055,"A high prevalence of discordant LDL-C/Lp(a) response was observed with alirocumab, further suggesting that PCSK9 inhibitor therapy with alirocumab reduces plasma Lp(a) through alternative pathways to LDL receptor clearance.","[{'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Mahmood', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Minnier', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Ito', 'Affiliation': 'Sanofi, USA.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals Inc., USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi, USA.'}, {'ForeName': 'Ivy W', 'Initials': 'IW', 'LastName': 'Kam', 'Affiliation': 'Regeneron Pharmaceuticals Inc., USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Fazio', 'Affiliation': 'Oregon Health & Science University, Knight Cardiovascular Institute, Center for Preventive Cardiology, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Shapiro', 'Affiliation': 'Center for Preventive Cardiology, Wake Forest University Baptist Medical Center, Section on Cardiovascular Medicine, USA.'}]",European journal of preventive cardiology,['10.1177/2047487320915803'] 3046,32453692,"Is thromboprophylaxis with high-dose enoxaparin really necessary for COVID-19 patients? A new ""prudent"" randomised clinical trial.",,2020,,[],['enoxaparin'],[],[],"[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]",[],,0.0745384,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'Intensive Cardiac Care Unit and ""De Gasperis"" Cardio Center, ""ASST Grande Ospedale Metropolitano Niguarda"", Milan, Italy.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0109-20'] 3047,32453693,"Rebuttal to letter ""Is thromboprophylaxis with high-dose enoxaparin really necessary for COVID-19 patients? A new ""prudent"" randomised clinical trial"".",,2020,,[],['enoxaparin'],[],[],"[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]",[],,0.0575995,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Department of Oncology and Haematology, University Hospital, Modena, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Tripodi', 'Affiliation': '""IRCCS Ca\' Granda Maggiore"" Hospital Foundation, ""Angelo Bianchi Bonomi"" Haemophilia and Thrombosis Center and ""Fondazione Luigi Villa"", Milan, Italy.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0116-20'] 3048,32453759,"Postoperative analgesia using dezocine alleviates depressive symptoms after colorectal cancer surgery: A randomized, controlled, double-blind trial.","BACKGROUND Postoperative depression is one of the most common mental disorders in patients undergoing cancer surgery and it often delays postoperative recovery. We investigated whether dezocine, an analgesic with inhibitory effect on the serotonin and norepinephrine reuptake, could relieve postoperative depressive symptoms in patients undergoing colorectal cancer surgery. METHODS This randomized, controlled, single-center, double-blind trial was performed in the Second Affiliated Hospital of the Army Medical University. A total of 120 patients were randomly assigned to receive either sufentanil (1.3 μg/kg) with dezocine (1 mg/kg) (dezocine group; n = 60) or only sufentanil (2.3 μg/kg) (control group; n = 60) for patient-controlled intravenous analgesia after colorectal cancer surgery. The primary outcome was the Beck Depression Inventory score at 2 days after surgery. The secondary outcomes included the Beck Anxiety Inventory, sleep quality, and quality of recovery scores. RESULTS Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001). No significant difference was found in other outcomes between the two groups. CONCLUSIONS Intravenous analgesia using dezocine can relieve postoperative depression symptoms and improve sleep quality in patients undergoing colorectal cancer surgery.",2020,"Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001).","['patients undergoing colorectal cancer surgery', 'A total of 120 patients', 'patients undergoing cancer surgery', 'alleviates depressive symptoms after colorectal cancer surgery', 'Second Affiliated Hospital of the Army Medical University']","['dezocine (1 mg/kg) (dezocine group; n = 60) or only sufentanil (2.3 μg/kg) (control group; n = 60) for patient-controlled intravenous analgesia after colorectal cancer surgery', 'sufentanil', 'dezocine', 'serotonin and norepinephrine reuptake']","['night sleep quality', 'lower depression scores', 'postoperative depressive symptoms', 'Beck Anxiety Inventory, sleep quality, and quality of recovery scores', 'postoperative depression symptoms', 'sleep quality', 'Beck Depression Inventory score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0362037', 'cui_str': 'Postoperative depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}]",120.0,0.70306,"Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001).","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Zhuoxi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Chunrui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guiying', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Guangyou', 'Initials': 'G', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Army Medical University, Chongqing, China.'}]",PloS one,['10.1371/journal.pone.0233412'] 3049,32453774,"Effect of guided counseling on dietary practices of pregnant women in West Gojjam Zone, Ethiopia.","BACKGROUND In Ethiopia, although nutrition education has been given during pregnancy, most women have inadequate nutrient intakes. As a result, the prevalence of malnutrition is high during pregnancy. In this study, we set out to evaluate the effect of guided counseling based on the health belief model and the theory of planned behavior on the dietary practices of pregnant women. METHODS A two-arm parallel cluster randomized controlled community trial was carried out among pregnant women in West, Gojjam Zone, Ethiopia from May 1, 2018, to April 30, 2019. A total of 346 and 348 pregnant women were recruited from the intervention and control clusters, respectively. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control groups, respectively. Each woman in the intervention group attended four counseling sessions. Women in the control group attended the routine nutrition education given by the health care system. Data were collected using a structured questionnaire. McNemar test and Generalized Estimating Equations were used to evaluate the intervention effect. RESULTS The average difference of appropriate dietary practice between the two groups was 30.7%. After controlling for the possible confounders, women in the intervention group had 7.2 times [AOR = 7.187, 95% CI: (4.49, 11.49)] higher odds of having appropriate dietary practices compared with the control group. Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively. CONCLUSION Counseling based on the health belief model and the theory of planned behavior is an effective approach in increasing the proportion of women who had appropriate dietary practices. Thus, these findings suggest the need for employing trimester based counseling using the HBM and the TPB to improve the dietary practices of pregnant women. TRIAL REGISTRATION The trial was registered in Clinical Trials.gov (NCT03627156).",2020,"Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively. ","['A total of 346 and 348 pregnant women', '313 and 332 pregnant women in the intervention and control groups, respectively', 'pregnant women in West, Gojjam Zone, Ethiopia from May 1, 2018, to April 30, 2019', 'pregnant women in West Gojjam Zone, Ethiopia', 'women who had appropriate dietary practices', 'pregnant women']","['routine nutrition education', 'guided counseling']",['Dietary diversity and meal frequency'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0585045,"Dietary diversity and meal frequency of counseled women were 7 [AOR = 6.994, 95% CI: (4.59, 10.66)] and 8 [AOR = 8.146, 95% CI: (5.377, 12.341)] times higher than dietary diversity and meal frequency of women in the control group, respectively. ","[{'ForeName': 'Yeshalem Mulugeta', 'Initials': 'YM', 'LastName': 'Demilew', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.'}, {'ForeName': 'Getu Degu', 'Initials': 'GD', 'LastName': 'Alene', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Public Health, Jimma University, Jimma, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0233429'] 3050,32462950,"Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors.","Background: Integrative oncology has proven to be a useful approach to control cancer symptoms and improve the quality of life (QoL) and overall health of patients, delivering integrated patient care at both physical and emotional levels. The objective of this randomized trial was to evaluate the effects of a triple intervention program on the QoL and lifestyle of women with breast cancer. Methods: Seventy-five survivors of stage IIA-IIB breast cancer were randomized into 2 groups. The intervention group (IG) received a 6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG). Data were gathered at baseline and at 6 months postintervention on QoL and adherence to Mediterranean diet using clinical markers and validated questionnaires. Between-group differences at baseline and 3 months postintervention were analyzed using Student's t test for related samples and the Wilcoxon and Mann-Whitney U tests. Results: At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05). Dyspnea symptoms were also increased in the CG versus IG ( p = .066). Conclusions: These results demonstrate that an integrative dietary, physical activity, and mindfulness program enhances the QoL and healthy lifestyle of stage IIA-IIB breast cancer survivors. Cancer symptoms may be better managed by the implementation of multimodal rather than isolated interventions.",2020,"At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05).","['women with breast cancer', 'Methods: Seventy-five survivors of stage IIA-IIB breast cancer', 'Stage IIA-IIB Breast Cancer Survivors']","['triple intervention program', '6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG', 'Multidisciplinary Program of Diet, Exercise, and Mindfulness']","['mean weight loss', 'body mass index', 'Mediterranean diet adherence', 'quality of life (QoL) and overall health', 'physical functioning', 'role functioning', 'Dyspnea symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1444651', 'cui_str': 'Not offered'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0282137,"At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ruiz-Vozmediano', 'Affiliation': '""Virgen de las Nieves"" University Hospital, Granada, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Löhnchen', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado', 'Affiliation': 'Mixed University Sport and Health Institute, Granada, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Recio', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rodríguez-Carrillo', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Mustieles', 'Affiliation': 'University of Granada, Granada, Spain.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Expósito', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain.'}, {'ForeName': 'Mariana F', 'Initials': 'MF', 'LastName': 'Fernández', 'Affiliation': 'University of Granada, Granada, Spain.'}]",Integrative cancer therapies,['10.1177/1534735420924757'] 3051,32460790,Higher doses of a green tea-based supplement increase post-exercise blood flow following an acute resistance exercise bout in recreationally resistance-trained college-aged men.,"BACKGROUND There are animal data suggesting green tea can enhance blood flow. However, human data are lacking. Thus, the purpose of this study was to examine the acute effects of low and high doses of a green tea-based supplement (GBS) on brachial artery blood flow before and following a resistance exercise bout. METHODS In this, double-blinded placebo-controlled trial, college-aged males (n = 18) who self-reported recreationally resistance training for the previous 6 ± 3 years were assigned to one of two studies including a low (300 mg serving) (n = 9) or high dose (600 mg serving) (n = 8; 1 drop) GBS study. During testing sessions, participants reported to the laboratory following an overnight fast and rested in a supine position for 15 min. Thereafter, baseline measurements for resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF) were obtained (PRE). Participants then consumed either their respective GBS dose or a similar placebo dose (microcrystalline cellulose) in a supine resting state. HR, SBP, DBP, BAD and BBF were measured 45 min after placebo or GBS ingestion (PRE2). Participants were then placed in a recumbent position and performed 4 sets of 10 arm curl repetitions using an 11 kg dumbbell. Participants returned to a supine position and HR, SBP, DBP, BAD and BBF were obtained within the first 3 min following exercise (POST), 15 min after exercise (15POST), and 45 min after exercise (45POST). Participants returned to the laboratory 24-48 h later to repeat the same protocol with either GBS or the placebo depending on randomization. Two-way (supplement x time) repeated measures ANOVAs were used to compare dependent variables between testing sessions for Study 1 (300 mg of GBS and placebo) and Study 2 (600 mg of GBS and placebo), and statistical significance was set at p < 0.05. No statistical comparisons were made between studies. RESULTS As expected, exercise increased BAD and BBF compared to resting baseline measured irrespective of supplementation. In addition, BAD and BBF did not differ between GBS and placebo at any time point after exercise in Study 1. In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD. CONCLUSIONS These data suggest a higher dose of GBS can enhance localized blood flow acutely following a resistance exercise bout. However, the long-term implications of these data are unclear, and more well-powered studies are needed to validate efficacy and elucidate potential mechanisms.",2020,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD. ","['college-aged males (n\u2009=\u200918) who self-reported recreationally resistance training for the previous 6\u2009±\u20093\u2009years', 'recreationally resistance-trained college-aged men']","['GBS and placebo', 'placebo dose (microcrystalline cellulose', 'green tea-based supplement (GBS', 'GBS', 'placebo (placebo', 'green tea-based supplement increase post-exercise blood flow', 'placebo']","['brachial artery blood flow', 'BAD and BBF', 'supine position and HR, SBP, DBP, BAD and BBF', 'baseline-normalized BBF', 'resting heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), brachial artery diameter (BAD) and blood flow (BBF', 'HR, SBP, DBP, BAD and BBF', 'blood flow']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]","[{'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}]",,0.322958,"In study 2, however, 600 mg GBS increased baseline-normalized BBF at immediately post exercise compared to placebo (placebo = 211 ± 155% increase, GBS = 349 ± 156% increase; p = 0.012) but not BAD. ","[{'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Fox', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Garner', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Petey W', 'Initials': 'PW', 'LastName': 'Mumford', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, Saint Charles, MO, USA.'}, {'ForeName': 'Darren T', 'Initials': 'DT', 'LastName': 'Beck', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roberts', 'Affiliation': 'Molecular and Applied Sciences Laboratory, School of Kinesiology, Auburn University, 301 Wire Road, Office 286, Auburn, AL, 36849, USA. mdr0024@auburn.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00358-5'] 3052,32460793,Influence of daily beer or ethanol consumption on physical fitness in response to a high-intensity interval training program. The BEER-HIIT study.,"BACKGROUND High-intensity interval training (HIIT) is an effective approach to improve physical fitness, but consuming beer, which is a regular practice in many physically active individuals, may interfere with these effects. The purposes of this study were to investigate the effects of a 10-week (2 days/week) HIIT program on cardiorespiratory fitness, muscle strength and power parameters, and also to assess the possible influence on them of a moderate consumption of beer (at least from Monday to Friday) or its alcohol equivalent. METHODS Young (24 ± 6 years old) healthy adults (n = 73, 35 females) were allocated to five groups. Four groups participated in the HIIT intervention program while the fifth group was a control Non-Training group (n = 15). Participants in the training groups chose whether they preferred receiving alcohol or alcohol-free beverages. Those choosing alcohol were randomized to either beer or ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n = 13) or (ii) T-Ethanol (sparkling water with vodka, 5.4%; n = 14). Those choosing alcohol-free intake were randomized to (iii) T-Water group (sparkling water, 0.0%; n = 16), or (iv) T-0.0Beer group (alcohol-free beer, 0.0%; n = 15). Men ingested 330 ml of the beverage at lunch and 330 ml at dinner; women ingested 330 ml at dinner. Before and after the intervention, maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps were measured. RESULTS HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength. These positive effects were not influenced by the regular intake of beer or alcohol. No changes in the vertical jumps occurred in any of the groups. CONCLUSIONS A moderate beer or alcohol intake does not mitigate the positive effect of a 10-week HIIT on physical fitness in young healthy adults. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT03660579. Registered 20 September 2018. Retrospectively registered.",2020,"RESULTS HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","['young healthy adults', 'Young (24\u2009±\u20096\u2009years old) healthy adults (n\u2009=\u200973, 35 females']","['beverage at lunch and 330\u2009ml at dinner; women ingested 330\u2009ml at dinner', 'HIIT intervention program', 'control Non-Training group', 'High-intensity interval training (HIIT', 'HIIT program', 'ethanol intake: (i) T-Beer group (alcohol beer, 5.4%; n\u2009=\u200913) or (ii) T-Ethanol', 'ethanol consumption', 'alcohol or alcohol-free beverages']","['absolute and relative values of VO 2 max, and total test duration', 'vertical jumps', 'physical fitness', 'maximal oxygen uptake in absolute and relative terms (VO 2 max.), maximal heart rate, total test duration, hand grip strength and four types of vertical jumps', 'cardiorespiratory fitness, muscle strength and power parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429930', 'cui_str': 'Test duration'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0166359,"RESULTS HIIT induced significant improvements in absolute and relative values of VO 2 max, and total test duration (all p < 0.05) in all the training groups; also, clinical improvements were found in hand grip strength.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Molina-Hidalgo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. criismh@correo.ugr.es.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dote-Montero', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain. amarof@ugr.es.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'EFFECTS 262 Department of Physiology, Faculty of Medicine, University of Granada, 18016, Granada, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00356-7'] 3053,32461289,Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial.,"INTRODUCTION Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN. METHODS AND ANALYSIS This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. ETHICS AND DISSEMINATION This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles. TRIAL REGISTRATION NUMBER NCT03822338.",2020,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. ","['Eligible participants will be patients with renal tumours and willing to choose elective LPN', 'renal function after laparoscopic partial nephrectomy']","['laparoscopic partial nephrectomy (LPN', 'Pneumoperitoneum preconditioning (PP', 'Pneumoperitoneum preconditioning']","['renal function', 'serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months', 'glomerular filtration rate and the level of serum cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022665', 'cui_str': 'Neoplasm of kidney'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]","[{'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0201885', 'cui_str': 'Amylase measurement, serum'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",,0.715931,"The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. ","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Luwei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Yuzheng', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Liuhua', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Nuclear Medicine Center, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Gaojian', 'Initials': 'G', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Tianli', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China.'}, {'ForeName': 'Ruipeng', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Urology, Nanjing First Hospital, Nanjing Medical University, Nangjing, Jiangsu, China urojiarp@njmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-032002'] 3054,32461297,Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study.,"INTRODUCTION Adalimumab is effective for maintenance of remission in patients with Crohn's disease (CD) at a dose of 40 mg subcutaneously every 2 weeks. However, adalimumab is associated with (long-term) adverse events and is costly. The aim of this study is to demonstrate non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening compared to standard dosing of every other week (EOW). METHODS AND ANALYSIS The Lengthening Adalimumab Dosing Interval (LADI) study is a pragmatic, multicentre, open label, randomised controlled non-inferiority trial. Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%. 174 CD patients on adalimumab maintenance therapy in long-term (>9 months) clinical and biochemical remission will be included (C-reactive protein (CRP) <10 mg/L, faecal calprotectin (FC) <150 µg/g, Harvey-Bradshaw Index (HBI) <5). Patients will be randomised 2:1 into the intervention (adalimumab interval lengthening) or control group (adalimumab EOW). The intervention group will lengthen the adalimumab administration interval to every 3 weeks, and after 24 weeks to every 4 weeks. Clinical and biochemical disease activity will be monitored every 12 weeks by physician global assessment, HBI, CRP and FC. In case of disease flare, dosing will be increased. A flare is defined as two of three of the following criteria; FC>250 µg/g, CRP≥10 mg/l, HBI≥5. Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness. ETHICS AND DISSEMINATION The study is approved by the Medical Ethics Committee Arnhem-Nijmegen, the Netherlands (registration number NL58948.091.16). Results will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBERS EudraCT registry (2016-003321-42); Clinicaltrials.gov registry (NCT03172377); Dutch trial registry (NTRID6417).",2020,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"['174\u2009CD patients on', ""quiescent Crohn's disease patients"", ""patients with Crohn's disease (CD""]","['CRP≥10 mg/l, HBI≥5', 'adalimumab', 'intervention (adalimumab interval lengthening) or control group (adalimumab EOW', 'Adalimumab', 'adalimumab interval lengthening', 'adalimumab maintenance therapy', 'Lengthening adalimumab']","['cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.22005,Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%.,"[{'ForeName': 'L J T', 'Initials': 'LJT', 'LastName': 'Smits', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'R W M', 'Initials': 'RWM', 'LastName': 'Pauwels', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'de Vries', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hoentjen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'van der Woude', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands c.vanderwoude@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035326'] 3055,32461298,Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance.,"INTRODUCTION Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for standard radical treatment with cystectomy or daily radiotherapy present a large unmet clinical need. Untreated, they suffer high cancer specific mortality and risk significant disease-related local symptoms. Hypofractionated radiotherapy (delivering higher doses in fewer fractions/visits) is a potential treatment solution but could be compromised by the mobile nature of the bladder, resulting in target misses in a significant proportion of fractions. Adaptive 'plan of the day' image-guided radiotherapy delivery may improve the precision and accuracy of treatment. We aim to demonstrate within a randomised multicentre phase II trial feasibility of plan of the day hypofractionated bladder radiotherapy delivery with acceptable rates of toxicity. METHODS AND ANALYSIS Patients with T2-T4aN0M0 MIBC receiving 36 Gy in 6-weekly fractions are randomised (1:1) between treatment delivered using a single-standard plan or adaptive radiotherapy using a library of three plans (small, medium and large). A cone beam CT taken prior to each treatment is used to visualise the anatomy and select the most appropriate plan depending on the bladder shape and size. A comprehensive radiotherapy quality assurance programme has been instituted to ensure standardisation of radiotherapy planning and delivery. The primary endpoint is to exclude > 30% acute grade > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2). Secondary endpoints include local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning. Target recruitment is 62 patients. ETHICS AND DISSEMINATION The trial is approved by the London-Surrey Borders Research Ethics Committee (13/LO/1350). The results will be disseminated via peer-reviewed scientific journals, conference presentations and submission to regulatory authorities. TRIAL REGISTRATION NUMBER NCT01810757.",2020,"The primary endpoint is to exclude > 30% acute grade > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","['Patients with T2-T4aN0M0 MIBC receiving 36\u2009Gy in 6-weekly fractions', 'Patients with muscle invasive bladder cancer (MIBC) who are unfit and unsuitable for', '62 patients']","['adaptive radiotherapy', 'standard radical treatment with cystectomy or daily radiotherapy', 'radiotherapy planning and delivery guidance', 'single-standard plan or adaptive radiotherapy', 'plan of the day hypofractionated bladder radiotherapy', 'hypofractionated adaptive radiotherapy', 'Hypofractionated radiotherapy']","['exclude > 30% acute grade > 3 non-genitourinary toxicity', 'local disease control, symptom control, late toxicity, overall survival, patient-reported outcomes and proportion of fractions benefiting from adaptive planning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454111', 'cui_str': 'Radiotherapy planning'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0852246', 'cui_str': 'Bladder radiotherapies'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0277565', 'cui_str': 'Local disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",,0.169588,"The primary endpoint is to exclude > 30% acute grade > 3 non-genitourinary toxicity at 3 months for adaptive radiotherapy in patients who received > 1 fraction (p0=0.7, p1=0.9, α=0.05, β=0.2).","[{'ForeName': 'Shaista', 'Initials': 'S', 'LastName': 'Hafeez', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK shaista.hafeez@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Patel', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Karole', 'Initials': 'K', 'LastName': 'Warren-Oseni', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Hansen', 'Affiliation': 'Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McNair', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Hospital, National Radiotherapy Trials Quality Assurance Group, Northwood, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037134'] 3056,32467099,LKB1 mutations are not associated with the efficacy of first-line and second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC): a post hoc analysis of the TAILOR trial.,"PURPOSE In patients with advanced lung adenocarcinoma, the impact of LKB1 mutations on cytotoxic chemotherapy efficacy remains poorly explored. Here, we aimed at investigating the potential impact of LKB1 mutational status on chemotherapy efficacy in advanced non-small-cell lung cancer (NSCLC) patients enrolled in the TArceva Italian Lung Optimisation tRial (TAILOR) trial. METHODS The multicenter TAILOR trial randomised patients with EGFR -wild type (wt) advanced NSCLC progressing on/after previous platinum-based chemotherapy to receive docetaxel or erlotinib. Here, we evaluated the impact of LKB1 mutational status on progression-free survival (PFS) and overall survival (OS) in patients treated with second-line docetaxel/erlotinib or during prior platinum-based chemotherapy. RESULTS Out of 222 patients randomised in the TAILOR trial, left-over tumour tissues were available for 188 patients, and 120 patients with evaluable LKB1 status were included. Of them, 17 (14.17%) patients had LKB1 -mutated tumours, while 103 (85.83%) had LKB1- wt disease. During second-line treatment, PFS and OS were not statistically significantly different in patients with LKB1- mutated when compared with LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively). Similarly, we found no significant association between LKB1 mutations and patient PFS or OS during prior first-line platinum-based chemotherapy (aHR=1.04, 95% CI 0.55 to 1.97; p=0.910 and aHR=0.83, 95% CI 0.42 to 1.65; p=0.602, respectively). CONCLUSION Among advanced NSCLC patients receiving two lines of systemic therapy, LKB1 mutations were not associated with PFS or OS during second-line docetaxel or prior first-line platinum-based chemotherapy. While larger prospective trials are needed to confirm our findings, cytotoxic chemotherapy remains the backbone of investigational combination strategies in this patient population.",2020,"During second-line treatment, PFS and OS were not statistically significantly different in patients with LKB1- mutated when compared with LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively).","['advanced NSCLC patients receiving two lines of systemic therapy', 'patients with EGFR -wild type (wt) advanced NSCLC progressing on/after previous platinum-based chemotherapy to receive', 'patients with advanced lung adenocarcinoma', '222 patients randomised in the TAILOR trial, left-over tumour tissues were available for 188 patients, and 120 patients with evaluable LKB1 status were included', 'patients with advanced non-small-cell lung cancer (NSCLC', 'advanced non-small-cell lung cancer (NSCLC) patients enrolled in the TArceva Italian Lung Optimisation tRial (TAILOR) trial', 'patients treated with second-line docetaxel/erlotinib or during prior platinum-based chemotherapy']",['docetaxel or erlotinib'],"['LKB1 mutations and patient PFS or OS', 'PFS and OS', 'chemotherapy efficacy', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1431123', 'cui_str': 'STK11 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1135136', 'cui_str': 'Tarceva'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C1431123', 'cui_str': 'STK11 protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",222.0,0.125564,"During second-line treatment, PFS and OS were not statistically significantly different in patients with LKB1- mutated when compared with LKB1- wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vernieri', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy claudio.vernieri@istitutotumori.mi.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ganzinelli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'Department of Oncology, ASST Fatebenefratelli Sacco, Milano, Lombardia, Italy.'}, {'ForeName': 'Anna Cecilia', 'Initials': 'AC', 'LastName': 'Bettini', 'Affiliation': 'Oncology Department, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bareggi', 'Affiliation': ""Oncology Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy.""}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rosso', 'Affiliation': ""Thoracic Surgery and Lung Transplant Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milano, Lombardia, Italy.""}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Signorelli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Galli', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lo Russo', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Proto', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Moro', 'Affiliation': 'Tumor Genomics Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Indraccolo', 'Affiliation': 'Immunology and Molecular Oncology Unit, Istituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Veneto, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Sozzi', 'Affiliation': 'Tumor Genomics Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Marabese', 'Affiliation': 'Laboratory of Molecular Pharmacology, Oncology Department, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Broggini', 'Initials': 'B', 'LastName': 'Massimo', 'Affiliation': 'Laboratory of Molecular Pharmacology, Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESMO open,['10.1136/esmoopen-2020-000748'] 3057,32469384,Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial.,"Importance Papillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group. Objective To determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib. Design, Setting, and Participants The SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened, to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened. Interventions Patients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment. Main Outcomes and Measures The primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability. Results At data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy. Conclusions and Relevance Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted. Trial Registration ClinicalTrials.gov Identifier: NCT03091192.",2020,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","['360 to 450 patients were to be screened, to randomize approximately 180 patients', 'Importance\n\n\nPapillary renal cell carcinoma ', '32 centers in 7 countries between July 2017 and the data cutoff in August 2019', '60 patients were randomized (savolitinib n\u2009=\u200933', '254 patients were screened', 'Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment', 'patients with MET-driven disease, study enrollment was closed', 'Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions', 'Patients With MET-Driven Papillary Renal Cell Carcinoma']","['PRCC', 'Savolitinib vs Sunitinib']","['progression-free survival (PFS', 'Median PFS', 'overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability', 'Progression-free survival, OS, and ORR']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.307135,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Cancel', 'Affiliation': 'CHU Bretonneau Centre, Tours University, France.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Ottesen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Oncology R&D, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Hernault"", 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szijgyarto', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2218'] 3058,32464082,Comparison of the Effects of Two Cochlear Implant Fine Structure Coding Strategies on Speech Perception.,"Purpose This study aims to investigate the effect of upgrading from the fine structure processing (FSP) coding strategy to the novel fine structure strategy ""FS4"" in adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria). Method A crossover, double-blinded study was conducted for 12 weeks. Twelve adult participants were randomly assigned to two groups. During the first 6-week test interval, one group continued to use their everyday FSP strategy, whereas the other group was upgraded to the FS4 strategy. In the second 6-week interval, the two groups switched coding strategies. Speech perception was measured at the end of each test interval with the Oldenburg Sentence Test and the Göttingen Sentence Test. Participants completed the Speech, Spatial and Qualities of Hearing Scale at the end of each test interval and a simple preference test at the end of the study. Results There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise. Participants' Speech, Spatial and Qualities of Hearing Scale self-evaluation and preference test results showed that the two coding strategies had similar effects on their hearing perception. No clear preference for either of the strategies was found. Conclusions Speech perception test results and the participants' level of satisfaction were similar for the two FS coding strategies. Despite differences in the presentation of temporal fine structure between FSP and FS4, a clear benefit of the newer FS4 strategy could not be shown.",2020,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","['adults in adults with cochlear implants manufactured by MED-EL GmbH (Innsbruck, Austria', 'Twelve adult participants']","['fine structure processing (FSP', 'Two Cochlear Implant Fine Structure Coding Strategies']","['Speech Perception', 'speech perception test', 'Speech perception', 'Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise', 'Speech, Spatial and Qualities of Hearing Scale', 'hearing perception']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}]","[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",12.0,0.0209095,"There was no significant difference in speech perception test results obtained with the Oldenburg Sentence Test and the Göttingen Sentence Test, neither in quiet nor in noise.","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Heinz Dieter', 'Initials': 'HD', 'LastName': 'Klünter', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Fürstenberg', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walger', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lang-Roth', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Cochlear Implant Center, Faculty of Medicine, University of Cologne, Germany.'}]",American journal of audiology,['10.1044/2020_AJA-19-00110'] 3059,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8'] 3060,32469621,Efficacy of Adalimumab in Non-Infectious Uveitis Across Different Etiologies: A Post Hoc Analysis of the VISUAL I and VISUAL II Trials.,"PURPOSE To assess efficacy of adalimumab versus placebo in patients with active or inactive noninfectious intermediate, posterior, or panuveitis across different etiologies. METHODS VISUAL I (V-I) and VISUAL II (V-II) clinical trials included adults with active or inactive uveitis, respectively, randomized to receive adalimumab or placebo. In a post hoc subgroup analysis, time to treatment failure (TTF) starting at week 6 (V-I) or week 2 (V-II) was analyzed using the Kaplan-Meier method. Hazard ratios (HR) for TTF with 95% CI were calculated with Cox proportional hazards regression. RESULTS The analysis included 217 V-I patients and 226 V-II patients. Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84]; P = .006) and V-II (HR = 0.43 [CI, 0.22-0.83]; P = .010). CONCLUSIONS Treatment failure risk was lower in patients with idiopathic noninfectious uveitis receiving adalimumab versus those receiving placebo.",2020,"Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84]; P = .006) and V-II (HR = 0.43","['217\xa0V-I patients and 226\xa0V-II patients', 'patients with idiopathic noninfectious uveitis receiving', 'Non-Infectious Uveitis', 'adults with active or inactive uveitis', 'patients with active or inactive noninfectious intermediate, posterior, or panuveitis across different etiologies']","['adalimumab', 'Adalimumab', 'adalimumab or placebo', 'placebo']",['Hazard ratios (HR'],"[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.362878,"Treatment failure occurred later and risk was significantly lower in patients with idiopathic uveitis receiving adalimumab versus those receiving placebo in V-I (HR = 0.50 [CI, 0.30-0.84]; P = .006) and V-II (HR = 0.43","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Department of Ophthalmology, Rush University Medical Center , Chicago, IL, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Vitale', 'Affiliation': 'John A. Moan Eye Center, University of Utah , Salt Lake City, UT, USA.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Zierhut', 'Affiliation': 'University of Tübingen , Tübingen, Germany.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Goto', 'Affiliation': 'Department of Ophthalmology, Tokyo Medical University , Tokyo, Japan.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kron', 'Affiliation': 'AbbVie Deutschland GmbH & Co KG , Ludwigshafen, Germany.'}, {'ForeName': 'Alexandra P', 'Initials': 'AP', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc ., North Chicago, IL, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Pathai', 'Affiliation': 'AbbVie Ltd , Maidenhead, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fortin', 'Affiliation': 'University of Montreal , Montreal, QC, Canada.'}]",Ocular immunology and inflammation,['10.1080/09273948.2020.1757123'] 3061,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞ ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384'] 3062,32471369,Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.,"BACKGROUND Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. METHODS A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. RESULTS Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. CONCLUSION Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. TRIAL REGISTRATION This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.",2020,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"['registration number 13804902 on 15 November 2017', 'nulliparas with unripe cervixes', '86 participants were analysed', 'university hospital in Malaysia', 'Participants were nulliparas at term with unripe cervixes (Bishop Score\u2009≤\u20095) admitted for IoL who were randomized to', 'Nulliparas with unripe cervix']","['speculum insertion of Foley catheter', 'Transcervical procedure', 'digital or speculum-aided transcervical Foley catheter insertion in lithotomy position', 'Speculum versus digital insertion of Foley catheter', 'Digital and speculum insertion']","['uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate', 'maternal satisfaction VNRS score', 'pain score', 'Insertion duration', 'insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position'}]","[{'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",86.0,0.415544,It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods.,"[{'ForeName': 'Hang Min', 'Initials': 'HM', 'LastName': 'Chia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. pctan@um.edu.my.'}, {'ForeName': 'Sze Ping', 'Initials': 'SP', 'LastName': 'Tan', 'Affiliation': ""King's College London, The Strand, London, WC2R 2LS, UK.""}, {'ForeName': 'Mukhri', 'Initials': 'M', 'LastName': 'Hamdan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zawiah', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03029-0'] 3063,32471373,"Percutaneous mastoid electrical stimulator improves Poststroke depression and cognitive function in patients with Ischaemic stroke: a prospective, randomized, double-blind, and sham-controlled study.","BACKGROUND Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function. METHODS This study was a prospective, randomized, double-blind, and sham-controlled study. A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N = 125) and sham plus antidepressant (sham group, N = 133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score ≤ 9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score < 26. RESULTS The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively). The mean value of the HRSD score change [M (month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (- 11.93 ± 5.32 vs - 10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores < 26 was lower in the PEMS group than in the sham group (12.0% vs 24.06%, P = 0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50 ± 2.55 vs 2.72 ± 2.52, P = 0.005, respectively). CONCLUSION These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition. TRIAL REGISTRATION This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018.",2020,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","['258 clinically depressed ischaemic stroke patients within 14\u2009days of index stroke', 'patients with Ischaemic stroke']","['PMES', 'PMES plus antidepressant (PMES group, N\u2009=\u2009125) and sham plus antidepressant', 'percutaneous mastoid electrical stimulator (PMES) plus antidepressants', 'Percutaneous mastoid electrical stimulator']","['mean value of the MoCA score change (M6-baseline', 'treatment response and depression remission', 'mean value of the HRSD score change [M (month)6-baseline', 'Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test', 'Poststroke depression and cognitive function', 'percentage of patients with a MoCA score\u2009<\u200926', 'poststroke depression and cognitive function', 'percentage of patients showing a treatment response', 'percentage of patients with MoCA scores', 'HRSD score) and depression remission (HRSD score']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",258.0,0.250207,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","[{'ForeName': 'Taoli', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China. 531324679@qq.com.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing, 400030, PR China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Electrical Engineering, Institute of Electrical Technology, Chongqing University, Chongqing, 400030, PR China.'}]",BMC neurology,['10.1186/s12883-020-01795-0'] 3064,32471514,Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study.,"BACKGROUND Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. AIMS AND OBJECTIVES To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation. OBJECTIVES 1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff. METHODS A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service. DISCUSSION Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions. TRIAL REGISTRATION ISRCTN17847169. Date registered: 15 December 2017.",2020,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. ",[],['relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training'],['effectiveness and cost-effectiveness'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4542877', 'cui_str': 'Pharmacist prescriber'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0796992,"A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. ","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Bond', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK. c.m.bond@abdn.ac.uk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, University of Leicester, Leicester, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Alldred', 'Affiliation': 'School of Healthcare, Baines Wing, University of Leeds, Leeds, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Arthur', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Birt', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Blyth', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'Addenbrookes Hospital, Cambridge, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Handford', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Athena Care Homes, Unit 2 Rima House, A13 Approach, Ripple Road, Barking, Essex, IG11 0RH, UK.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Maskrey', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Massey', 'Affiliation': 'Norfolk & Suffolk Primary and Community Care Research Office, hosted by South Norfolk Clinical Commissioning Group, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, Scotland, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Norris', 'Affiliation': 'School of Education & Lifelong Learning University of East Anglia, Norwich, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Poland', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Zermansky', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04264-8'] 3065,32460179,Preclinical profile and phase I clinical trial of a novel androgen receptor antagonist GT0918 in castration-resistant prostate cancer.,"PURPOSE We conducted preclinical experiments and phase I clinical trial to investigate the safety, pharmacokinetics (PK) and antitumour effects of GT0918 in castration-resistant prostate cancer (CRPC). EXPERIMENTAL DESIGN An androgen receptor (AR) competitive binding assay was performed, followed by evaluation of GT0918 on AR protein expression. The efficacy of GT0918 was investigated in a castration-resistant xenograft model. A phase I dose-escalation study of GT0918 in CRPC was also carried out to evaluate its safety, PK and antitumour efficacy. RESULTS GT0918 was demonstrated to inhibit the binding of androgen to AR more potently than MDV3100, and to effectively reduce the AR protein level. GT0918 inhibited the transcriptional activity of wild-type AR and AR with clinically relevant ligand-binding domain mutations. Furthermore, GT0918 significantly inhibited the growth of prostate cancer. A total of 16 patients was treated with GT0918 at five dose levels. Among these 16 patients, 10 and 2 patients, respectively, completed a three-cycle and six-cycle treatment, in which MTD was not reached. All the treatment-related adverse events were grade I, including hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia. PK parameters showed that drug exposure increased with dose proportionally from 50 to 300 mg and a saturation was observed between 300 and 400 mg. PSA declines of ≥30% and ≥50% were, respectively, observed in six and two cases. All the 12 patients with metastatic soft tissue lesions confirmed stable disease. CONCLUSIONS GT0918, a full AR antagonist without agonist effect, has high binding affinity to AR with AR protein down-regulation activity. GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC. CLINICALTRIALS: gov identifier CTR20150501.",2020,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"['castration-resistant prostate cancer (CRPC', 'castration-resistant prostate cancer', '12 patients with metastatic soft tissue lesions confirmed stable disease']",['novel androgen receptor antagonist GT0918'],"['safety, pharmacokinetics (PK) and antitumour effects', 'growth of prostate cancer', 'PSA declines', 'AR protein level', 'safety, PK\xa0and antitumour efficacy', 'transcriptional activity of wild-type AR and AR', 'hypercholesterolemia, hypertriglyceridemia, fatigue and anaemia']","[{'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0410013', 'cui_str': 'Soft tissue lesion'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936804', 'cui_str': 'Androgen Receptor Antagonists'}, {'cui': 'C4043276', 'cui_str': 'GT0918'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",16.0,0.014045,GT0918 is demonstrated to be well tolerated with a favourable PK profile and exhibits promising antitumour activity in CRPC.,"[{'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fubo', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qianxiang', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Shancheng', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China.'}, {'ForeName': 'Chunyun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Suzhou Kintor Pharmaceuticals, Suzhou, Jiangsu, China. Electronic address: cychen@kintor.com.cn.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: sunyhsmmu@126.com.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.013'] 3066,32460220,Ultrasound imaging evaluation of structural and textural features in asymptomatic achilles tendons in pre-professional dancers: A cross-sectional study.,"OBJECTIVE To evaluate performance descriptors, sociodemographics variables and tendon echogenicity of asymptomatic Achilles tendons and to compare the echotexture from different classification subgroups. DESIGN A prospective, randomized cross-sectional study was carried out. SETTING laboratory of university. PARTICIPANTS Forty-two Achilles tendons (AT) were recruited from pre-professional dancers. Based on the echogenicity pattern, the sample was divided into two groups (n = 21, Heterogeneous group; n = 21, Homogeneous group). MAIN OUTOCOME MEASURES Ultrasound images and ImageJ measurements were performed to evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test were measured as performance parameter. RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups. AT-TH, endurance test, balance test, years of dance, training hours per week and average pointe hours per week did not showed differences between groups. A multivariate prediction model between groups and the echotexture variables (EI (R 2  = 0.569; EV (R 2  = 0.341)) were determined. CONCLUSION Asymptomatic AT of heterogeneous group showed a lower EI and a higher EV compared to homogeneous group. Tendon echogenicity did not interact with performance variables.",2020,"RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","['laboratory of university', 'Forty-two Achilles tendons (AT) were recruited from pre-professional dancers', 'asymptomatic achilles tendons in pre-professional dancers']",[],"['evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test', 'Tendon echogenicity']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.0279145,"RESULTS EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: irebargar@gmail.com.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Almazán-Polo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: jaime.almazan@universidadeuropea.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Jaén-Crespo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: gjaencrespo@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.05.008'] 3067,32460697,"The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study.","BACKGROUND Elevated Staphylococcus aureus and oral bacterial concentrations are known to correlate with pneumonia hospitalization in nursing home residents. However, the effects of a professional oral care intervention on these factors remain unclear. The aims of this quasi-experimental study were to compare bacterial concentrations in saliva and sputum, oral health status, distribution of Staphylococcus aureus, and pneumonia status before and after a professional oral care intervention. METHODS A purposive sample of residents from two nursing homes was divided into an intervention group that received a weekly professional oral care intervention and a control group. Oral bacterial concentration was determined by real-time polymerase chain reaction. The Staphylococcus aureus distribution was determined by bacterial culture and matrix-assisted laser desorption/ionization-time of flight mass spectrometry. After data collection, a statistical analysis was performed to evaluate the effect of the intervention. RESULTS Most residents were unconscious (80%), and most had a history of pneumonia (76%). Baseline demographic data did not significantly differ between the two groups. After the intervention, the intervention group had significant improvements in plaque index (1.66 ± 0.78 vs. 0.94 ± 0.64, p <  0.01), gingival index (2.36 ± 0.76 vs. 1.65 ± 0.83, p <  0.01), tongue coating index (0.96 ± 1.10 vs. 0.16 ± 0.47, p <  0.01), distribution of Staphylococcus aureus in salivary samples (11.11 ± 14.47% vs. 1.74 ± 3.75%, p = 0.02), and salivary bacterial concentration ([4.27 ± 3.65] × 10 5 vs. [0.75 ± 1.20] × 10 5 , p <  0.01). Sputum bacterial concentration did not significantly differ. The intervention group also had a significantly lower annual prevalence of pneumonia hospitalization (1.24 ± 1.51 vs. 0.48 ± 0.59, p = 0.01), especially in residents whose salivary bacterial concentration exceeded the median. However, the duration of pneumonia hospitalization did not significantly differ between the two groups. CONCLUSION A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization. TRIAL REGISTRATION Trial registration: ClinicalTrials.gov, NCT03874962. Registered 12 March 2019 - Retrospectively registered.",2020,"A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization. ","['nursing home residents', 'A purposive sample of residents from two nursing homes', 'Taiwan nursing home residents']","['professional oral care intervention', 'professional oral care intervention and a control group', 'oral care intervention']","['distribution of Staphylococcus aureus in salivary samples', 'Sputum bacterial concentration', 'annual prevalence of pneumonia hospitalization', 'salivary bacterial concentration', 'bacterial concentrations in saliva and sputum, oral health status, distribution of Staphylococcus aureus, and pneumonia status', 'pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration', 'oral health, reduce levels of salivary bacteria and Staphylococcus aureus', 'tongue coating index', 'Oral bacterial concentration', 'history of pneumonia', 'duration of pneumonia hospitalization', 'gingival index', 'Baseline demographic data', 'plaque index']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0009144', 'cui_str': 'Furred tongue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455542', 'cui_str': 'H/O: pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",,0.0851238,"A professional oral care intervention in nursing home residents can improve oral health, reduce levels of salivary bacteria and Staphylococcus aureus, and decrease the annual prevalence of pneumonia hospitalization. ","[{'ForeName': 'Tien-Cheng', 'Initials': 'TC', 'LastName': 'Chiang', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, No.100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan.'}, {'ForeName': 'Ming-Shyan', 'Initials': 'MS', 'LastName': 'Huang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, E-DA Cancer Hospital, No. 21, Yida Rd., Yanchao Dist., Kaohsiung City, 824, Taiwan.'}, {'ForeName': 'Po-Liang', 'Initials': 'PL', 'LastName': 'Lu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Kaohsiung Medical University Hospital, No.100, Tzyou 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan.'}, {'ForeName': 'Shun-Te', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Division of Special Care Dentistry, Department of Dentistry, Kaohsiung Medical University Hospital, No.100, Tzyou 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan. shuntehuang@gmail.com.'}, {'ForeName': 'Ying-Chu', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, No.100, Shiquan 1st Rd., Sanmin Dist., Kaohsiung City, 807, Taiwan. chulin@kmu.edu.tw.'}]",BMC infectious diseases,['10.1186/s12879-020-05061-z'] 3068,32460699,"Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.","BACKGROUND Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an α 2 -adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs. METHODS This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A total of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.4 μg/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 μg/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7 days after surgery. RESULTS The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7 days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P = 0.017). In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516). When the total dose of DEX was more than 328 μg, the patients were unlikely to have PPCs (ROC curve, AUC = 0.614, P = 0.009). CONCLUSIONS For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7 days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension. TRIAL REGISTRATION Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.",2020,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","['160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'number', 'patients after oral and maxillofacial surgery with fibular free flap reconstruction']","['DEX or placebo (normal saline', 'DEX', 'Dexmedetomidine', 'Dexmedetomidine (DEX', 'maxillofacial surgery with fibular free flap reconstruction and tracheotomy', 'placebo']","['postoperative pulmonary complications', 'incidence of PPCs according to Clavien-Dindo score', 'length of hospital stay', 'occurrence of PPCs', 'prevalence of bradycardia or hypotension', 'incidence of PPCs', 'postoperative survival probability']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0411582', 'cui_str': 'Reconstruction with free flap'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",160.0,0.736349,"In the first 7 days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less prone to occur PPCs (Cox regression, P = 0.025, HR = 0.516).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, 100191, China. 3917798@qq.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081, China. kqyangxudong@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01045-3'] 3069,32460801,The addition of β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation does not improve anthropometric and performance maintenance across a collegiate rugby season.,"BACKGROUND Muscular damage sustained while playing rugby may hinder performance across a season. β-Hydroxy β-Methylbutyrate (HMB) may help attenuate muscle damage and maintain lean mass and performance. This study sought to determine the effect of combining HMB with creatine monohydrate supplementation on measures of stress and muscle damage, body composition, strength and sprinting kinetics throughout a rugby season. METHODS This double-blind, cross-over investigation recruited 16 male collegiate rugby players to provide resting blood samples and complete assessments of body composition, strength and sprinting performance prior to their fall season (PRE FALL ). After testing, the athletes were matched for fat-free mass and assigned to consume one of two supplementation regimens for 6 weeks: 5 g HMB + 5 g creatine per day (HMB-Cr: 20.9 ± 1.1 years; 177 ± 2 cm; 88.4 ± 4.9 kg) or 5 g creatine + 5 g placebo per day (Cr: 21.4 ± 2.1 years; 179 ± 2 cm; 88.3 ± 4.9 kg). After 6 weeks (POST FALL ), PRE FALL testing was repeated in 13 of the original 16 athletes before a 10-wk wash-out period. Athletes who returned for the spring season (n = 8) repeated all fall-season procedures and testing prior to (PRE SPRING ) and following (POST SPRING ) their 6-wk spring season, except they were assigned to the opposite supplementation regimen. RESULTS Linear mixed models with repeated measures revealed group x time interactions (p <  0.05) for observed for several measures but did not consistently and positively favor one group. During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring. In the spring, greater knee flexor rate of torque development (~ 149 Nm·sec - 1 , p = 0.003) and impulse (~ 4.5 Nm·sec, p = 0.022) were observed in Cr at PRE SPRING but not at POST SPRING . Although significant interactions were found for cortisol concentrations, vastus lateralis pennation angle, and sprinting force, post-hoc analysis only revealed differences between fall and spring seasons. No other differences were observed. CONCLUSIONS The combination of HMB and creatine monohydrate supplementation does not provide a greater ergogenic benefit compared to creatine monohydrate supplementation alone. Body composition, strength, and sprinting ability did not change across the season with creatine monohydrate supplementation.",2020,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.",['16 male collegiate rugby players'],"['β-Hydroxy β-Methylbutyrate (HMB', 'β-Hydroxy β-Methylbutyrate (HMB) to creatine monohydrate supplementation', 'HMB and creatine monohydrate supplementation', 'HMB\u2009+\u20095\u2009g creatine per day (HMB-Cr: 20.9\u2009±\u20091.1\u2009years; 177\u2009±\u20092\u2009cm; 88.4\u2009±\u20094.9\u2009kg) or 5\u2009g creatine +\u20095\u2009g placebo', 'HMB with creatine monohydrate supplementation']","['measures of stress and muscle damage, body composition, strength and sprinting kinetics', 'knee extensor peak torque', 'body composition, strength and sprinting performance prior to their fall season (PRE FALL ', 'Body composition, strength, and sprinting ability', 'knee flexor rate of torque development', 'cortisol concentrations, vastus lateralis pennation angle, and sprinting force']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",16.0,0.209374,"During the fall season, knee extensor peak torque was reduced by 40.7 ± 28.1 Nm (p = 0.035) for HMB-Cr but remained consistent for Cr, and no group differences or changes were noted in the spring.","[{'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia. gmangine@kennesaw.edu.'}, {'ForeName': 'Trisha A', 'Initials': 'TA', 'LastName': 'VanDusseldorp', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Hester', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Julian', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Feito', 'Affiliation': 'Exercise Science and Sport Management, Kennesaw State University, 520 Parliament Garden Way NW, 30144, Kennesaw, GA, Georgia.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00359-4'] 3070,32460804,Views among Malawian women about joining HIV prevention clinical trials when pregnant.,"BACKGROUND The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. METHODS We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. RESULTS A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. CONCLUSIONS The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.",2020,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","['35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa', 'Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy']",['oral PrEP (Truvada) (2) a vaginal ring (dapivirine'],[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0574464', 'cui_str': 'Nyanja language'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]",[],3.0,0.0678425,"Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA. ksullivan@med.unc.edu.'}, {'ForeName': 'Tiwonge', 'Initials': 'T', 'LastName': 'Mtande', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Jaffe', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Health Behavior, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 170 Rosenau Hall, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Chifundo', 'Initials': 'C', 'LastName': 'Zimba', 'Affiliation': 'UNC Project Malawi, Tidziwe Centre, Private Bag A-104, Lilongwe, Malawi.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Bioinformatics Building, 130 Mason Farm Road, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Little', 'Affiliation': 'The Kennedy Institute of Ethics, Georgetown University, 3700 O Street Northwest, Washington, DC, 20057, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Faden', 'Affiliation': 'Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Anne Drapkin', 'Initials': 'AD', 'LastName': 'Lyerly', 'Affiliation': 'Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, 333 S. Columbia Street, Campus Box 7240, Chapel Hill, NC, 27599, USA.'}]",AIDS research and therapy,['10.1186/s12981-020-00271-6'] 3071,32460811,Glioma patients in outpatient care-optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial.,"BACKGROUND Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support. However, due to neurological and neurocognitive deficits, adequate assessment of distress and support needs remains challenging in clinical practice. The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap. METHODS/DESIGN This is a multicenter cluster randomized study with two arms. Randomization is done on a cluster level with 13 hospitals providing regular neuro-oncological outpatient services conducted by neurologists and/or neurosurgeons. The intervention will include an assessment of psychosocial distress of patients in doctor-patient conversation compared to assessment of psychosocial distress via questionnaire (control, standard of care). In total, 616 HGG patients will be enrolled. The outcome will be the number of HGG patients with increased psychosocial distress who receive professional support from psychosocial services. Secondary endpoints are inter alia number of patients reporting psychosocial distress and unmet needs detected correctly by the respective method; quality of life; psychological well-being and burden of the patients before and after doctor-patient consultation; as well as the length of the doctor-patient consultation. DISCUSSION Patients with HGG are confronted with an oncological diagnosis and at the same time with high symptom burden. This often leads to distress, which is not always adequately recognized and treated. So far, only a limited number of adequate instruments are available to assess HGG patient's distress. Yet, an adequate care and support network might facilitate the course of the disease and tumor therapies for patients. Our hypothesis is that an assessment conducted directly by attending doctors and in which the doctors talk to patients with HGG will be more effective than an assessment via a questionnaire, leading to better identifying patients in need of support. This may lead to an improvement of health care in these patients. Further, this method might be implemented also in other brain tumor patients (e.g., patients with brain metastases). TRIAL REGISTRATION German Clinical Trials Register, DRKS00018079. Registered on 3rd September 2019.",2020,"The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap. ","['616 HGG patients will be enrolled', 'Patients with high-grade gliomas (HGG) often suffer from high distress and require psychosocial support', '13 hospitals providing regular neuro-oncological outpatient services conducted by neurologists and/or neurosurgeons', 'Glioma patients in outpatient care-optimization of psychosocial care in neuro-oncological patients (GLIOPT']","['doctor-patient conversation compared to assessment of psychosocial distress via questionnaire (control, standard of care']","['psychosocial distress', 'inter alia number of patients reporting psychosocial distress and unmet needs detected correctly by the respective method; quality of life; psychological well-being and burden of the patients before and after doctor-patient consultation; as well as the length of the doctor-patient consultation']","[{'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0237427', 'cui_str': 'Neurosurgeon'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0740885', 'cui_str': 'Alias'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",616.0,0.0533018,"The objective of the present study is to investigate whether a systematic implementation of signaling questions into the routine outpatient consultation will be helpful to bridge this gap. ","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Renovanz', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany. mirjam.renovanz@med.uni-tuebingen.de.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Hippler', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wehinger', 'Affiliation': 'Department of Neurology, Clinic Ludwigsburg, Ludwigsburg, Germany.'}, {'ForeName': 'Almuth F', 'Initials': 'AF', 'LastName': 'Keßler', 'Affiliation': 'Department of Neurosurgery, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gempt', 'Affiliation': 'Department of Neurosurgery, Klinikum Rechts Der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Minou', 'Initials': 'M', 'LastName': 'Nadji-Ohl', 'Affiliation': 'Department of Neurosurgery, Klinikum Stuttgart, Katharinenhospital (KH), Stuttgart, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Weiß Lucas', 'Affiliation': 'Center for Neurosurgery, University Hospital Cologne, Faculty of Medicine, University of Cologne, Köln, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Rapp', 'Affiliation': 'Department of Neurosurgery, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misch', 'Affiliation': 'Department of Neurosurgery, Charité - University Medical Center Berlin, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Coburger', 'Affiliation': 'Department of Neurosurgery, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Mehlitz', 'Affiliation': 'Department of Neurosurgery, Klinikum Barmherzige Brueder Trier, Trier, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Meixensberger', 'Affiliation': 'Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Keric', 'Affiliation': 'Department of Neurosurgery, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Blettner', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schranz', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Singer', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.'}]",Trials,['10.1186/s13063-020-04321-2'] 3072,32460816,"Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer.","INTRODUCTION Neoadjuvant endocrine therapy (NET) has demonstrated efficacy in post-menopausal patients with hormone-responsive breast cancer. This trial was designed to compare the efficacy of neoadjuvant chemotherapy (NCT) with NET in pre-menopausal breast cancer. PATIENTS AND METHODS In this prospective, randomised, phase III study, oestrogen receptor (ER)-positive, HER2-negative, and lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea. Enrolled patients were randomly assigned (1:1) to receive 24 weeks of either NCT or NET with goserelin and tamoxifen. The primary purpose was to evaluate the non-inferiority of NET compared to NCT using clinical response, assessed by MRI. Besides, pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life were included as secondary endpoints. RESULTS A total of 187 patients were assigned to receive NCT (n = 95) or NET (n = 92), and 87 patients in each group completed treatments. More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046). Three NCT patients (3.4%) and one NET patient (1.2%) showed pCR (p < 0.005). No difference existed in the conversion rate of BCS (13.8% for NCT vs. 11.5% for NET, p = 0.531) and Ki-67 change (p = 0.114) between the two groups. Nineteen NCT patients had treatment-related grade 3 or worse events compared with none in the NET group. CONCLUSIONS Better clinical responses were observed in pre-menopausal patients after 24 weeks of NCT compared to those observed after NET. TRIAL REGISTRATION Clinicaltrials.gov, NCT01622361. Registration June 19, 2012.",2020,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","['pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer', 'post-menopausal patients with hormone-responsive breast cancer', 'lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea', 'A total of 187 patients']","['NCT or NET with goserelin and tamoxifen', 'NCT', 'Neoadjuvant endocrine therapy (NET', 'NET', 'neoadjuvant endocrine therapy', 'neoadjuvant chemotherapy (NCT) with NET', 'neoadjuvant chemotherapy']","['Ki-67 change', 'pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life', 'conversion rate of BCS', 'complete response or partial response']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",187.0,0.239105,"More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046).","[{'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea.'}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Center for Breast Cancer, Research and Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, School of Medicine, Ajou University, Suwon, South Korea.'}, {'ForeName': 'Lee Su', 'Initials': 'LS', 'LastName': 'Kim', 'Affiliation': 'Division of Breast and Endocrine Surgery, Hallym Sacred Heart Hospital, College of Medicine, Hallyum University, Anyang, South Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Surgery and Cancer Research Institute, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Department of Surgery, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Gyung -Yub', 'Initials': 'G-', 'LastName': 'Gong', 'Affiliation': 'Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hwa Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sei Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic ro 43 gil, song pa gu, Seoul, 138-736, South Korea. ahnsh@amc.seoul.kr.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01288-5'] 3073,32466746,Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial.,"BACKGROUND It is unclear whether regional anesthesia with infraclavicular nerve block or general anesthesia provides better postoperative analgesia after distal radial fracture fixation, especially when combined with regular postoperative analgesic medications. The aim of this study was to compare the postoperative analgesic effects of regional versus general anesthesia. METHODS In this prospective, observer blinded, randomized controlled trial, 52 patients undergoing distal radial fracture fixation received either general anesthesia (n = 26) or regional anesthesia (infraclavicular nerve block, n = 26). Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status were evaluated after surgery. RESULT Regional anesthesia was associated with significantly lower pain scores both at rest and with movement on arrival to the post-anesthetic care unit; and at 1, 2, 24 and 48 h after surgery (p ≤ 0.001 at rest and with movement). Morphine consumption in the post-anesthetic care unit was significantly lower in the regional anesthesia group (p<0.001). There were no differences in oral analgesic consumption. Regional anesthesia was associated with lower incidences of nausea (p = 0.004), and vomiting (p = 0.050). Patient satisfaction was higher in the regional anesthesia group (p = 0.003). There were no long-term differences in pain scores and other patient outcomes. CONCLUSION Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia. TRIAL REGISTRATION Before subject enrollment, the study was registered at ClinicalTrials.gov (NCT03048214) on 9th February 2017.",2020,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia. ","['after distal radial fracture fixation', '52 patients undergoing distal radial fracture fixation received either']","['Regional anesthesia with ultrasound guided infraclavicular nerve block', 'general anesthesia (n\u2009=\u200926) or regional anesthesia (infraclavicular nerve block, n\u2009=\u200926', 'Infraclavicular nerve block']","['Patient satisfaction', 'pain scores', 'postoperative pain', 'Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status', 'vomiting', 'acute pain relief', 'oral analgesic consumption', 'Morphine consumption', 'nausea', 'postoperative analgesic effects']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",52.0,0.47479,"Regional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia. ","[{'ForeName': 'Stanley S', 'Initials': 'SS', 'LastName': 'Wong', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China. wongstan@hku.hk.'}, {'ForeName': 'Wing S', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Chan', 'Affiliation': 'Department of Anaesthesiology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Lau', 'Affiliation': 'Department of Orthopaedics and Traumatology, Queen Mary Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Leung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chi W', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': 'Laboratory and Clinical Research Institute for Pain, Department of Anaesthesiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Room 424, Block K, 102, Pokfulam Road, Hong Kong SAR, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01044-4'] 3074,32466773,The effects of combined magnesium and zinc supplementation on metabolic status in patients with type 2 diabetes mellitus and coronary heart disease.,"BACKGROUND The present research aimed to analyze the impacts of magnesium and zinc supplements on glycemic control, serum lipids, and biomarkers of oxidative stress and inflammation in patients suffering from coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM). METHODS According to the research design, a randomized, double-blind, placebo-controlled trial has been implemented on 60 subjects suffering from CHD and T2DM. Therefore, participants have been randomly divided into 2 groups for taking placebo (n = 30) or 250 mg magnesium oxide plus 150 mg zinc sulfate (n = 30) for 12 weeks. RESULTS Magnesium and zinc significantly decreased fasting plasma glucose (FPG) (β - 9.44 mg/dL, 95% CI, - 18.30, - 0.57; P = 0.03) and insulin levels (β - 1.37 μIU/mL, 95% CI, - 2.57, - 0.18; P = 0.02). Moreover, HDL-cholesterol levels significantly enhanced (β 2.09 mg/dL, 95% CI, 0.05, 4.13; P = 0.04) in comparison to the placebo. There was an association between magnesium and zinc intake, and a significant decrease of C-reactive protein (CRP) (β - 0.85 mg/L, 95% CI, - 1.26, - 0.45; P < 0.001), a significant increase in total nitrite (β 5.13 μmol/L, 95% CI, 1.85, 8.41; P = 0.003) and total antioxidant capacity (TAC) (β 43.44 mmol/L, 95% CI, 3.39, 83.50; P = 0.03) when compared with placebo. Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo. CONCLUSIONS In patients with T2DM and CHD, the 12-week intake of magnesium plus zinc had beneficial effects on FPG, HDL-cholesterol, CRP, insulin, total nitrite, TAC levels, and BDI and BAI score. This suggests that magnesium and zinc co-supplementation may be beneficial for patients with T2DM and CHD. Further studies on more patients and lasting longer are needed to determine the safety of magnesium and zinc co-supplementation. TRIAL REGISTRATION Current Controlled Trials http://www.irct.ir: IRCT20130211012438N31 at 11 May 2019 of registration. This study retrospectively registered.",2020,"Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo. ","['patients with T2DM and CHD', '60 subjects suffering from CHD and T2DM', 'patients suffering from coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM', 'patients with type 2 diabetes mellitus and coronary heart disease']","['magnesium and zinc co-supplementation', 'magnesium plus zinc', 'magnesium and zinc supplements', 'magnesium oxide plus 150\u2009mg zinc sulfate', 'combined magnesium and zinc supplementation', 'placebo']","['Beck Anxiety Inventory (BAI', 'total nitrite', 'C-reactive protein (CRP', 'fasting plasma glucose (FPG', 'total antioxidant capacity (TAC', 'metabolic status', 'Beck Depression Inventory index (BDI', 'FPG, HDL-cholesterol, CRP, insulin, total nitrite, TAC levels, and BDI and BAI score', 'glycemic control, serum lipids, and biomarkers of oxidative stress and inflammation', 'HDL-cholesterol levels', 'insulin levels', 'magnesium and zinc intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}]",60.0,0.535227,"Furthermore, magnesium and zinc significantly reduced the Beck Depression Inventory index (BDI) (β - 1.66; 95% CI, - 3.32, - 0.009; P = 0.04) and Beck Anxiety Inventory (BAI) (β - 1.30; 95% CI, - 2.43, - 0.16; P = 0.02) when compared with the placebo. ","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hamedifard', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farrokhian', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'Department of Internal Medicine, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ghotbi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran. taghizadeh.mohsen22@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01298-4'] 3075,32467299,Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma.,"BACKGROUND A pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) showed a higher than anticipated objective response rate (ORR) among patients with metastatic melanoma (MM). We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma. METHODS Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible. There was a 1:1 randomization to SBRT + IL-2 or IL-2 monotherapy. Patients received one or two doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting the first cycle of IL-2. IL-2 (600,000 IU per kg via intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Responding patients received up to six IL-2 cycles. Patients assigned to IL-2 monotherapy who exhibited progression of melanoma after cycle 2 were allowed to crossover and receive SBRT and additional IL-2. Response Evaluation Criteria in Solid Tumors 1.1 criteria were applied to non-irradiated lesions for response assessment. RESULTS 44 patients were included in the analysis. The ORR in the SBRT + IL-2 group was 54%: 21% complete response (CR), 33% partial response (PR), 21% stable disease (SD) and 25% progressive disease (PD). The ORR in patients receiving IL-2 monotherapy was 35%: 15% CR, 20% PR, 25% SD and 40% PD. Seven patients assigned to IL-2 subsequently received SBRT + IL-2. One CR and two PRs were observed in the crossover group. There was no difference in progression-free or overall survival (OS). At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group. The disease control rate (DCR) was higher in the SBRT + IL-2 group (75% vs 60%, p=0.34). CONCLUSIONS SBRT + IL-2 induced more objective responses with a higher DCR compared to IL-2 monotherapy in MM. IL-2 monotherapy resulted in a significantly higher ORR than anticipated. Some patients in the crossover group also achieved objective responses. TRIAL REGISTRATION NUMBER NCT01416831.",2020,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"['patients with advanced melanoma', 'patients with metastatic melanoma (MM', '44 patients were included in the analysis', 'Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible', 'patients with metastatic melanoma']","['IL-2', 'monotherapy', 'IL-2 monotherapy', 'SBRT + IL-2', 'SBRT', 'stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2', 'stereotactic body radiotherapy and interleukin-2 versus interleukin-2']","['objective response rate (ORR', 'progression-free or overall survival (OS', 'ORR', 'objective responses', 'disease control rate (DCR', 'ORR of SBRT + IL-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]",44.0,0.306046,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Curti', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA brendan.curti@providence.org.'}, {'ForeName': 'Marka', 'Initials': 'M', 'LastName': 'Crittenden', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Seung', 'Affiliation': 'Division of Radiation Oncology, The Oregon Clinic, Portland, Oregon, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Fountain', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Payne', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'ShuChing', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Medical Data Research Center, Providence St Joseph Health, Portland, Oregon, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleser', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Malkasian', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Lyn B', 'Initials': 'LB', 'LastName': 'Dobrunick', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Urba', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000773'] 3076,32467354,"Engaging men to transform inequitable gender attitudes and prevent intimate partner violence: a cluster randomised controlled trial in North and South Kivu, Democratic Republic of Congo.","INTRODUCTION The study objective was to understand the effectiveness of Engaging Men through Accountable Practice (EMAP), a group-based discussion series which sought to transform gender relations in communities, on intimate partner violence (IPV), gender inequitable attitudes and related outcomes. METHODS A two-armed, matched-pair, cluster randomised controlled trial was conducted between 2016 and 2018 in eastern Democratic Republic of Congo. Adult men (n=1387) and their female partners (n=1220) participated in the study. The primary outcomes of the study were female report of past year physical and/or sexual IPV and men's intention to commit violence. Secondary outcomes included men's gender attitudes, women's economic and emotional IPV, women's perception of negative male behaviours and perceived quality of the relationship. RESULTS Men in EMAP reported significant reductions in intention to commit violence (β=-0.76; SE=0.23; p<0.01), decreased agreement with any reason that justifies wife beating (OR=0.59; SE=0.08; p<0.01) and increased agreement with the ability of a woman to refuse sex for all reasons (OR=1.47; SE=0.24; p<0.05), compared with men in the control group. We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71). However, female partners of men in EMAP reported significant improvements to the quality of relationship (β=0.28; p<0.05) and significant reductions in negative male behaviour (β=-0.32; p<0.01). CONCLUSION Interventions engaging men have the potential to change gender attitudes and behaviours in conflict-affected areas. However, while EMAP led to changes in gender attitudes and behaviours related to perpetration of IPV, the study showed no overall reduction of women's experience of IPV. Further research is needed to understand how working with men may lead to long-term and meaningful changes in IPV and related gender equitable attitudes and behaviours in conflict areas. TRIAL REGISTRATION NUMBER NCT02765139.",2020,We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71).,"['2016 and 2018 in eastern Democratic Republic of Congo', 'Adult men ', 'North and South Kivu, Democratic Republic of Congo', 'n=1387) and their female partners (n=1220) participated in the study']","['Engaging Men through Accountable Practice (EMAP', 'EMAP']","['negative male behaviour', ""female report of past year physical and/or sexual IPV and men's intention to commit violence"", 'intention to commit violence', ""men's gender attitudes, women's economic and emotional IPV, women's perception of negative male behaviours and perceived quality of the relationship"", 'intimate partner violence']","[{'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0680385,We found no statistically significant differences in women's experiences of IPV between treatment and control group at follow-up (physical or sexual IPV: adjusted OR=0.95; SE=0.14; p=0.71).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Vaillant', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA jvaillant@worldbank.org.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Koussoubé', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'Violence Prevention and Response Unit, International Rescue Committee, Tunis, Tunisia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Pierotti', 'Affiliation': 'Africa Gender Innovation Lab, World Bank, Washington, DC, USA.'}, {'ForeName': 'Mazeda', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'Airbel Impact Lab, International Rescue Committee, Washington, DC, USA.'}]",BMJ global health,['10.1136/bmjgh-2019-002223'] 3077,32469183,Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.,"BACKGROUND Injectable luteinizing hormone-releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known. METHODS In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. Secondary end points included noninferiority with respect to the primary end point, castrate levels of testosterone on day 4, and profound castrate levels (<20 ng per deciliter) on day 15. Testosterone recovery was evaluated in a subgroup of patients. RESULTS A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88). CONCLUSIONS In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).",2020,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"['Advanced Prostate Cancer', 'men with advanced prostate cancer', '622 patients received relugolix and 308 received', 'patients with advanced prostate cancer']","['luteinizing hormone-releasing hormone agonists (e.g., leuprolide', 'Oral Relugolix', 'leuprolide', 'relugolix']","['castrate levels of testosterone on day 4, and profound castrate levels', 'Testosterone recovery', 'sustained testosterone suppression to castrate levels', 'mean testosterone levels', 'incidence of major adverse cardiovascular events', 'castrate levels of testosterone', 'superiority of relugolix over leuprolide', 'noninferiority and superiority of relugolix']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]",622.0,0.384751,All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001).,"[{'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Saltzstein', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'van Veenhuyzen', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Selby', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kang', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Walling', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': ""From the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); the University of Montreal Hospital Center, Montreal (F.S.); the Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City (M.S.C.); the Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC (D.J.G.); Urology San Antonio, San Antonio, TX (D.R.S.); Chesapeake Urology, Towson, MD (R.T.); the Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies-Graduate School of Interdisciplinary Information Studies, University of Tokyo, Tokyo (H.A.); the Department of Radiation Oncology, Gustave Roussy Cancer Institute, Villejuif, France (A.B.); Myovant Sciences, Brisbane, CA (D.F.V., B.S., X.F., V.K., J.W.); and Service d'Urologie, Cliniques Universitaires Saint Luc, Brussels (B.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004325'] 3078,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978'] 3079,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population. METHODS This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH. CONCLUSION This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047'] 3080,32474978,"""I don't think I took her fears seriously"": Exploring the experiences of family members of individuals at-risk of developing psychosis over 12 months.","Individuals with an at-risk mental state (ARMS) of psychosis experience high levels of distress, anxiety, low mood, and suicidal ideation. Families of ARMS individuals provide significant support but are often neglected by services. This study is the first of its kind to use a novel longitudinal qualitative methodology to directly compare family/carers' earlier experiences supporting ARMS individuals to 12 months later. This provides a more ecologically valid insight into how perceptions change over time and how family/carers adapt. Semistructured interviews were conducted with 10 family/carers at two points within a 12-month period. This study was embedded within a randomized control trial, the Individual and Family Cognitive Behavioural Therapy trial. Interview transcripts were analysed using thematic analysis, with a focus on how experiences and reactions for family/carers changed over time. Over 12 months, four factors were important for family/carers to facilitate their caring role. These were summarized in the thematic map (LACE model): Looking after your own well-being; Accessing additional support from family intervention; Communicating openly with the individual; and Engaging with services for the individual. All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs, and helping them to feel more confident and less isolated in their carer role. Novel implications suggest that when feasible, services should involve family/carers of ARMS individuals in sessions and explore family/carer support strategies in managing their own distress. The most significant insight was the need to develop family/carer resources to educate, normalize, and validate their own experiences.",2020,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","['Individuals with an At Risk Mental State (ARMS) of psychosis experience high-levels of distress, anxiety, low mood and suicidal ideation']",['Individual and Family Cognitive Behavioural Therapy (IFCBT'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0176856,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Izon', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Berry', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2483'] 3081,32475836,Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.,"INTRODUCTION This randomized controlled trial investigated community-clinical intervention strategies for a Mexican American population who had not demonstrated control of their diabetes. We tested a control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version (Salud y Vida 2.0) for reductions in HbA1c at 12 months. RESEARCH DESIGN AND METHODS Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c≥8.0% at SyV 2.0 baseline enrollment. The control and intervention arms were coordinated by community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family. RESULTS At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)). The intervention group maintained HbA1c levels after month 6, whereas control group HbA1c levels slightly increased (adjusted mean from 9.83% at month 6%-9.90% at month 12). Also, HbA1c was examined by level of participant engagement. The high engagement group showed a decreasing trend over the study period, while control and lower engagement groups failed to maintain HbA1c levels at month 12. CONCLUSIONS Improved HbA1c was found among a population that had not demonstrated diabetes management prior; however, mean HbA1c values were above clinical guideline recommendations. The randomized control trial findings provide additional evidence that extended time and intervention supports may be needed for populations experiencing inequities in social determinants of health. TRIAL REGISTRATION NUMBER NCT04035395.",2020,"At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)).","[""Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c≥8.0% at SyV 2.0 baseline enrollment"", 'Mexican American population who had not demonstrated control of their diabetes']","['community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family', 'control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version']","['HbA1c (mean, (CI), Control', 'maintain HbA1c levels', 'HbA1c levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",353.0,0.0442403,"At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)).","[{'ForeName': 'Belinda M', 'Initials': 'BM', 'LastName': 'Reininger', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA Belinda.M.Reininger@uth.tmc.edu.'}, {'ForeName': 'MinJae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Hessabi', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mitchell-Bennett', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Maribel R', 'Initials': 'MR', 'LastName': 'Sifuentes', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Guerra', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Ciara D', 'Initials': 'CD', 'LastName': 'Ayala', 'Affiliation': 'Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, School of Public Health, Brownsville Regional Campus, Brownsville, Texas, USA.'}, {'ForeName': 'Tianlin', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Polletta', 'Affiliation': 'Research and Evaluation, Health Resources in Action, Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Research and Evaluation, Health Resources in Action, Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Rahbar', 'Affiliation': 'Division of Clinical and Translational Sciences, Department of Internal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000867'] 3082,32476513,Feasibility and Effects of a Supervised Exercise Program Suitable for Independent Training at Home on Physical Function and Quality of Life in Head and Neck Cancer Patients: A Pilot Study.,"Introduction: Head and neck cancer patients often suffer from physical and cognitive impairments after cancer treatment. During rehabilitation, exercise therapy can improve physical function and quality of life (QoL). Surveys demonstrated patients' preference for home training with low- to moderate-intensity. This study was conducted in order to develope a suitable home-based training program. Therefore, the feasibility and effects of a low- to moderate-intensity exercise intervention on physical functions and QoL were evaluated. Methods: Training was conducted as supervised group training and consisted of mobilization, coordination, resistance, stretching, and relaxation exercises. The intervention lasted 12 weeks with 2 training sessions per week. Feasibility, attendance rate, physical function (eg, range of motion, 6-minute walk test [6MWT]), and QoL (eg, EORTC QLQ-30) were analyzed. Results: Ten out of 12 participants completed the intervention (83%) with an average attendance rate of 83%. Participants showed significant improvements in selected physical functions. For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059). Additionally, there were positive changes in the physical function scale ( P = .008), cognitive function scale ( P = .015), and social function scale ( P = .031) of the EORTC QLQ-30. Conclusion : Data indicate that the exercise program was feasible and had positive effects on physical function and QoL. Future research will analyze the effects of a home-based exercise program on physical function and QoL in a large-scale study.",2020,"For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059).","['12 participants completed the intervention (83%) with an average attendance rate of 83', 'Head and Neck Cancer Patients', 'cancer patients often suffer from physical and cognitive impairments after cancer treatment']","['exercise therapy', 'supervised group training and consisted of mobilization, coordination, resistance, stretching, and relaxation exercises', 'Supervised Exercise Program', 'low- to moderate-intensity exercise intervention']","['Feasibility, attendance rate, physical function (eg, range of motion, 6-minute walk test [6MWT]), and QoL (eg, EORTC QLQ-30', 'cognitive function scale', 'Physical Function and Quality of Life', 'physical function and quality of life (QoL', 'physical functions and QoL', 'walking distance in the 6MWT', 'social function scale', 'selected physical functions', 'head rotation', 'global QoL scale', 'physical function scale']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0203993', 'cui_str': 'Relaxation exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",12.0,0.0150438,"For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059).","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Felser', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Behrens', 'Affiliation': 'Institute of Sport Science, University of Rostock, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liese', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Daniel Fabian', 'Initials': 'DF', 'LastName': 'Strueder', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Rhode', 'Affiliation': 'Department of Physiotherapy, Rostock University Medical Center, Rostock, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Junghanss', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grosse-Thie', 'Affiliation': 'Department of Medicine, Clinic III - Hematology, Oncology and Palliative Care, Rostock University Medical Center, Rostock Germany.'}]",Integrative cancer therapies,['10.1177/1534735420918935'] 3083,32476558,"Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care.","OBJECTIVE The aim of this study was to determine the effect of web-based education and counselling for patients with systemic lupus erythematosus on self-efficacy, fatigue and assessment of care. METHODS The study was conducted as a randomized controlled trial. The study sample consisted of 80 patients divided into two groups: the experimental group ( n  = 40) and a control group ( n  = 40). Randomization was performed by simple random sampling. At the beginning of the study (month 0), data-collection forms were administered to both groups. Web-based education was carried out for the first three months, and counselling and information updates were given for the next three months for the experimental group. In the intervention process, the control group just received standard care. After six months, data-collection forms were administered to both groups again. RESULTS The mean age of the participants in the experimental and control groups was 35.58 ± 8.40 years and 39.00 ± 12.71 years, respectively. In both groups, 95% of patients were women. Wilcoxon's test was used for within-group comparisons before and after the study. The Mann-Whitney U -test was used to evaluate the difference between the two groups before the intervention and between the two groups after the intervention. We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). CONCLUSIONS The intervention had a positive effect on self-efficacy, fatigue and satisfaction with chronic illness. In accordance with the results, similar studies should be conducted for different patient groups in order to strengthen the results.",2020,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). ","['The mean age of the participants in the experimental and control groups was 35.58\u2009±\u20098.40 years and 39.00\u2009±\u200912.71 years, respectively', 'patients with systemic lupus erythematosus']","['standard care', 'web-based education and counselling']","['fatigue, self-efficacy and assessment of chronic illness care', 'self-efficacy, fatigue and satisfaction with chronic illness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",80.0,0.0447442,"We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study ( p  < 0.05). ","[{'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Kankaya', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}, {'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Karadakovan', 'Affiliation': 'Ege University, Faculty of Nursing, Department of Medical Nursing, Izmir, Turkey.'}]",Lupus,['10.1177/0961203320928423'] 3084,32460818,Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial.,"BACKGROUND Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty. METHODS The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 10 9 /L, MASCC (Multinational Association of Supportive Care in Cancer) score ≥ 21 and receiving IV piperacillin/tazobactam or meropenem for less than 24 h are eligible to participate. Patients are randomised 1:1 either (i) to switch to oral ciprofloxacin and co-amoxiclav within 12-24 h of commencing intravenous antibiotics, completing at least 5 days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48 h, with ongoing antibiotics being continued at the physician's discretion (control). Patients are discharged home when their physician deems it appropriate. The primary outcome measure is a composite of treatment failures as assessed at day 14. The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death. Based on a 15% treatment failure rate in the control group and a 15% non-inferiority margin, the recruitment target is 230 patients. DISCUSSION If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis. TRIAL REGISTRATION ISRCTN: 84288963. Registered on the 1 July 2015. https://doi.org/10.1186/ISRCTN84288963. EudraCT: 2015-002830-35.",2020,"The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death.","['patients receiving systemic anti-cancer treatment', '16\u2009years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of >\u200938\u2009°C, neutrophil count ≤ 1.0\u2009×\u200910 9 /L, MASCC (Multinational Association of Supportive Care in Cancer) score\u2009≥\u200921 and receiving IV', 'for less than 24\u2009h are eligible to participate', 'Patients ≥', 'patients with cancer who have low-risk neutropenic sepsis', 'cancer patients with low-risk neutropenic sepsis']","['piperacillin/tazobactam or meropenem', 'early switching from intravenous to oral antibiotics', ""oral ciprofloxacin and co-amoxiclav within 12-24\u2009h of commencing intravenous antibiotics, completing at least 5\u2009days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48\u2009h, with ongoing antibiotics being continued at the physician's discretion (control"", 'oral antibiotic therapy', 'EudraCT']","['patient quality of life and resource savings', 'composite of treatment failures', 'failure rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0877153', 'cui_str': 'Neutropenic sepsis'}]","[{'cui': 'C0250480', 'cui_str': 'Piperacillin and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559681', 'cui_str': 'Oral antibiotic therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.197475,"The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Forde', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Lisburn Road, Belfast, BT9 7AE, UK. cforde01@qub.ac.uk.""}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'McMullan', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Translational Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grayson', 'Affiliation': 'Northern Ireland Cancer Research Consumer Forum, Belfast, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'McDowell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Doran', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Danny F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': 'The Wellcome Wolfson Institute for Experimental Medicine, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Thomas', 'Affiliation': 'Leicester Cancer Research Centre, Leicester, UK.'}, {'ForeName': 'Rosemary A', 'Initials': 'RA', 'LastName': 'Barnes', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Cardiff University and Velindre NHS Trust, Cardiff, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Coyle', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Lisburn Road, Belfast, BT9 7AE, UK.""}]",Trials,['10.1186/s13063-020-04241-1'] 3085,32460875,Correction to: Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"[""patients with Parkinson's disease""]",['robot-assisted gait training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]",[],,0.0670688,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Min-Gu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Seo Jung', 'Initials': 'SJ', 'LastName': 'Yun', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Iee', 'Initials': 'HI', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Eunkyung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Hyun Haeng', 'Initials': 'HH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Byung-Mo', 'Initials': 'BM', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, South Korea. hgseo80@gmail.com.'}]",Trials,['10.1186/s13063-020-04437-5'] 3086,32466147,The Effects of Multifaceted Ergonomic Interventions on Musculoskeletal Complaints in Intensive Care Units.,"Working at intensive care units (ICUs) is considered a risk factor for developing musculoskeletal complaints (MSC). This study was conducted between January 2017 and June 2019 in two ICUs of a university hospital. It was designed as a pre- and post-assessment of the intervention group (IG) (N = 27) compared with a control group (CG) (N = 23) to determine the effects of a multifaceted ergonomics intervention program in reducing MSC. The IG (N: 35) received a multifaceted ergonomic intervention program, which was implemented by an ERGO team over an 18 month period. Four ergonomic interventions were planned as follows: individual level interventions such as training; stretching exercises and motivation meetings; administrative intervention such as a daily 10 min stretching exercises break; engineering interventions such as lifting and usage of auxiliary devices. The CG (N:29) did not receive any intervention. Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) was used to assess MSC in both groups. At the start of the intervention, both groups were similar concerning the number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores ( p > 0.05 for all). Two factor repeated ANOVA measures were performed for between-groups and within-group analyses. The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p < 0.001). However, the interaction effect of group and time (between and within factors) was not significant ( p = 0.992). Work-related MSC is a common occupational health problem among nurses. This study showed that individual-level interventions are not likely to succeed in eliminating manual patient lifting by nurses. Our results suggested that interventions without administrative measures might have limited success.",2020,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p < 0.001).,"['Musculoskeletal Complaints in Intensive Care Units', 'January 2017 and June 2019 in two ICUs of a university hospital']","['multifaceted ergonomics intervention program', 'multifaceted ergonomic intervention program', 'Multifaceted Ergonomic Interventions']","['number of visits to doctors due to MSC, the number of sick leave days, and total CMDQ scores', 'mean of the initial CMSDQ total scores', 'Cornell Musculoskeletal Discomfort Questionnaire (CMDQ']","[{'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0244086,The mean of the initial CMSDQ total scores in both groups increased significantly in the 18th month ( p < 0.001).,"[{'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Coskun Beyan', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Dilek', 'Affiliation': 'Physical Therapy and Rehabilitation Department, Dokuz Eylul University, Izmir 35220, Turkey.'}, {'ForeName': 'Yucel', 'Initials': 'Y', 'LastName': 'Demiral', 'Affiliation': 'Occupational Medicine Department, Dokuz Eylul University, Izmir 35220, Turkey.'}]",International journal of environmental research and public health,['10.3390/ijerph17103719'] 3087,32468883,The use of mind mapping in health education in extended care for children with caries.,"OBJECTIVE To investigate the application of mind mapping-based health education in extended care for children with caries. METHODS This was a prospective study of 159 eligible children with caries. Participants were randomly assigned to an observation group and a control group, and received extended health education and guidance. Patients in the observation group received health education with mind mapping. In the third month after the first visit, a questionnaire survey was conducted to assess knowledge of extended caries diagnosis and treatment in children and their parents. Children also underwent a bacterial plaque test. RESULTS Caries knowledge was significantly greater in the observation group than in the control group. There was no significant between-group difference in debris index on the bacterial plaque test. The observation group had a significantly greater number of follow-up visits in 12 months than the control group. CONCLUSIONS Mind mapping was effective in the implementation of extended care. Mind mapping information was more accessible to children and their parents, increasing their compliance with health education. Thus, mind mapping is an appropriate health education tool for use in extended care for children with caries.",2020,There was no significant between-group difference in debris index on the bacterial plaque test.,"['159 eligible children with caries', 'children with caries']","['health education with mind mapping', 'mind mapping-based health education', 'control group, and received extended health education and guidance']","['number of follow-up visits', 'Caries knowledge', 'debris index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",159.0,0.0311492,There was no significant between-group difference in debris index on the bacterial plaque test.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Xue-Bin', 'Initials': 'XB', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Ming-He', 'Initials': 'MH', 'LastName': 'Li', 'Affiliation': 'Department of Dentofacial Surgery, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatric Dentistry, Hospital of Stomatology, Jilin University, Changchun, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Comprehensive, Hospital of Stomatology, Jilin University, Changchun, China.'}]",The Journal of international medical research,['10.1177/0300060519898053'] 3088,32468955,Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial.,"PURPOSE In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs. PATIENTS AND METHODS Patients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease. RESULTS There were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48; P < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85; P = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03). CONCLUSION In patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.",2020,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03). ","['patients with HER2-positive breast cancer', 'Patients', 'Previously Treated HER2-Positive Breast Cancer', 'participants with BMs', 'patients with HER2-positive breast cancer with BMs', '291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm', 'patients with measurable intracranial disease', 'patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs']","['baseline brain magnetic resonance imaging', 'Tucatinib Plus Trastuzumab and Capecitabine', 'tucatinib or placebo, in combination with trastuzumab and capecitabine']","['risk of intracranial progression or death', 'Risk of death', 'ORR-IC', 'Median OS', 'risk of death', 'intracranial efficacy and survival', 'Median CNS-PFS', 'Intracranial Efficacy and Survival', 'intracranial objective response rate (ORR-IC', 'antitumor activity against BMs', 'CNS-PFS (intracranial progression or death) and overall survival (OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]",291.0,0.139198,"ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03). ","[{'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Borges', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Anders', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Paplomata', 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology-Nashville, Nashville, TN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles Medical Center/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'Royal Marsden National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': 'Bedard', 'Affiliation': 'University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Hospital Universitario Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Mueller', 'Affiliation': 'Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Zelnak', 'Affiliation': 'Northside Hospital, Atlanta, GA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'DiGiovanna', 'Affiliation': 'Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': ""O'Regan"", 'Affiliation': 'Carbone Cancer Center/University of Wisconsin, Madison, WI.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'Christie NHS Foundation Trust, Manchester Academic Health Science Centre & Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Providence Cancer Institute, Portland, OR.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Cancer Research Centre, Edinburgh, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, University of Milano, Milan, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer-Vancouver Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'JoAl', 'Initials': 'J', 'LastName': 'Mayor', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'McGoldrick', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Xuebei', 'Initials': 'X', 'LastName': 'An', 'Affiliation': 'Seattle Genetics, Bothell, WA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00775'] 3089,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients. MATERIAL AND METHODS A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end). RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. CONCLUSIONS This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869'] 3090,32469870,"Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial.","Obtaining a nutrient-rich diet during pregnancy is a challenge for pregnant women living in low-income countries. This randomized, controlled trial was designed to determine if a freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables given prior to and/or during pregnancy improved birth outcomes in rural Vietnamese women. Primiparous women, 18 to 30 years of age, who participated in the study were assigned to one of three groups: PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care. Supplement intake was observed and quantified. Infant anthropometry was measured at birth and/or within seven days of delivery. The effect of the intervention on maternal and birth outcomes was determined using linear regression modeling. Of the 460 women enrolled in the study, 317 women completed the study. Those not completing the study had either moved from the area, did not conceive within 12 months of study enrollment, or miscarried. The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups. However, it failed to alter infant anthropometric measurements at birth. In the entire cohort, maternal gestational weight gain was greater in women with a low pre-pregnancy BMI (<18.5) and in women with a higher educational attainment. Working as a farmer reduced gestational weight gain but it did not affect birth weight or length. In summary, a nutrient-rich, food-based supplement given to rural Vietnamese women from pre-conception to term or mid-gestation to term did not affect maternal or infant outcomes. The low weight gains, possibly due to demanding farm work done throughout the reproductive cycle, may have obviated any effects of the low energy, nutrient-rich food supplement on birth outcomes. Trial registration : Registered Clinical Trials.gov: NCT01235767.",2020,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","['rural Vietnamese women', 'pregnant women living in low-income countries', 'Primiparous women, 18 to 30 years of age, who participated in the study', 'rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes', '460 women enrolled in the study, 317 women completed the study']","['freshly prepared food supplement from local animal-source foods and dark-green leafy vegetables', 'nutrient-rich, food-based supplement', 'nutrient-rich diet', 'PC-T women received the supplement from pre-conception to term, MG-T women received the supplement from mid-gestation to term, and the RPC women received routine prenatal care']","['protein, iron, zinc, folate, vitamin A and B12 intakes', 'maternal gestational weight gain', 'low weight gains', 'gestational weight gain', 'maternal and birth outcomes', 'birth weight or length']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C2348897', 'cui_str': 'Green leafy vegetable'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0231246', 'cui_str': 'Failure to gain weight'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",317.0,0.162934,"The food-based supplement increased protein, iron, zinc, folate, vitamin A and B12 intakes in the PC-T and the MG-T groups.","[{'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Nguyen T', 'Initials': 'NT', 'LastName': 'Diep Anh', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232197'] 3091,32469881,"Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial.","BACKGROUND Distal radius fractures are common fractures and the cornerstone of treatment remains immobilization of the wrist in a cast. At present, there is a scarcity of studies that compare different cast immobilization methods. The objective of the study was therefore to compare volar-flexion and ulnar deviation cast to functional cast position in the treatment of dorsally displaced distal radius fracture among elderly patients. METHODS AND FINDINGS We performed a pragmatic, randomized, controlled trial in three emergency centers in Finland. After closed reduction of the fracture, the wrist was placed in either volar-flexion and ulnar deviation cast or functional cast position. The follow-up was 12 months. The primary outcome was patient-rated wrist evaluation (PRWE) score at 12 months. The secondary outcomes were Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale. The number of complications was also recorded. In total, 105 participants were included in the study. Of these, 88% were female and the mean age was 73.5 (range 65-94) years. In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9 (95% CI: -13.1.- 3.4., p = .24) in favor of the functional cast position. Operative treatment due to loss of reduction of fracture was performed for four patients (8%) in the FC group and for seven patients (13%) in the volar-flexion and ulnar deviation cast group (OR: 0.63, 95% CI: 0.16-2.1). CONCLUSION In this study, the data were consistent with a wide range of treatment effects when comparing two different cast positions in the treatment of distal radius fracture among elderly patients at 12-month follow-up. However, the functional cast is more likely to be superior when compared to volar-flexion and ulnar deviation cast. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02894983 Accessible: https://clinicaltrials.gov/ct2/show/NCT02894983.",2020,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","['88% were female and the mean age was 73.5 (range 65-94) years', 'dorsally displaced distal radius fracture among elderly patients', '105 participants were included in the study', ""patients with Colles' fracture"", 'three emergency centers in Finland']",['volar-flexion and ulnar deviation cast to functional cast position'],"['Quick-DASH score, grip strength, health-related quality of life (15D), and pain catastrophizing scale', 'patient-rated wrist evaluation (PRWE) score', 'patient-rated wrist evaluation measure', 'number of complications', 'reduction of fracture', 'distal radius fracture']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009353', 'cui_str': ""Colles' fracture""}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",105.0,0.170183,"In the primary analysis, the mean difference in patient-rated wrist evaluation measure between groups was -4.9","[{'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Raittio', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Antti P', 'Initials': 'AP', 'LastName': 'Launonen', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Hevonkorpi', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Luokkala', 'Affiliation': 'Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Satakunta Central Hospital, Pori, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Reito', 'Affiliation': 'Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Minna K', 'Initials': 'MK', 'LastName': 'Laitinen', 'Affiliation': 'Division of Orthopaedics and Traumatology, Unit of Musculoskeletal Surgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}]",PloS one,['10.1371/journal.pone.0232153'] 3092,32470438,"Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.","BACKGROUND Transfusion-dependent haemoglobinopathies require lifelong iron chelation therapy with one of the three iron chelators (deferiprone, deferasirox, or deferoxamine). Deferasirox and deferiprone are the only two oral chelators used in adult patients with transfusion-dependent haemoglobinopathies. To our knowledge, there are no randomised clinical trials comparing deferiprone, a less expensive iron chelator, with deferasirox in paediatric patients. We aimed to show the non-inferiority of deferiprone versus deferasirox. METHODS DEEP-2 was a phase 3, multicentre, randomised trial in paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies. The study was done in 21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK. Participants were receiving at least 150 mL/kg per year of red blood cells for the past 2 years at the time of enrolment, and were receiving deferoxamine (<100 mg/kg per day) or deferasirox (<40 mg/kg per day; deferasirox is not registered for use in children aged <2 years so only deferoxamine was being used in these patients). Any previous chelation treatment was permitted with a 7-day washout period. Patients were randomly assigned 1:1 to receive orally administered daily deferiprone (75-100 mg/kg per day) or daily deferasirox (20-40 mg/kg per day) administered as dispersible tablets, both with dose adjustment for 12 months, stratified by age (<10 years and ≥10 years) and balanced by country. The primary efficacy endpoint was based on predefined success criteria for changes in serum ferritin concentration (all patients) and cardiac MRI T2-star (T2*; patients aged >10 years) to show non-inferiority of deferiprone versus deferasirox in the per-protocol population, defined as all randomly assigned patients who received the study drugs and had available data for both variables at baseline and after 1 year of treatment, without major protocol violations. Non-inferiority was based on the two-sided 95% CI of the difference in the proportion of patients with treatment success between the two groups and was shown if the lower limit of the two-sided 95% CI was greater than -12·5%. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with EudraCT, 2012-000353-31, and ClinicalTrials.gov, NCT01825512. FINDINGS 435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group). 352 (90%) of 390 patients had β-thalassaemia major, 27 (7%) had sickle cell disease, five (1%) had thalassodrepanocytosis, and six (2%) had other haemoglobinopathies. Median follow-up was 379 days (IQR 294-392) for deferiprone and 381 days (350-392) for deferasirox. Non-inferiority of deferiprone versus deferasirox was established (treatment success in 69 [55·2%] of 125 patients assigned deferiprone with primary composite efficacy endpoint data available at baseline and 1 year vs 80 [54·8%] of 146 assigned deferasirox, difference 0·4%; 95% CI -11·9 to 12·6). No significant difference between the groups was shown in the occurrence of serious and drug-related adverse events. Three (2%) cases of reversible agranulocytosis occurred in the 193 patients in the safety analysis in the deferiprone group and two (1%) cases of reversible renal and urinary disorders (one case of each) occurred in the 197 patients in the deferasirox group. Compliance was similar between treatment groups: 183 (95%) of 193 patients in the deferiprone group versus 192 (97%) of 197 patients in the deferisirox group. INTERPRETATION In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment. Considering the need for availability of more chelation treatments in paediatric populations, deferiprone offers a valuable treatment option for this age group. FUNDING EU Seventh Framework Programme.",2020,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","['paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2', 'paediatric patients with transfusion-dependent', '21 research hospitals and universities in Italy, Egypt, Greece, Albania, Cyprus, Tunisia, and the UK', 'paediatric patients (aged 1 month to 18 years) with transfusion-dependent haemoglobinopathies', 'group versus 192 (97%) of 197 patients in the deferisirox group', '435 patients were enrolled between March 17, 2014, and June 16, 2016, 393 of whom were randomly assigned to a treatment group (194 to the deferiprone group; 199 to the deferasirox group', 'adult patients with transfusion-dependent haemoglobinopathies', 'paediatric patients']","['daily deferasirox', 'daily deferiprone', 'deferoxamine', 'haemoglobinopathies, deferiprone', 'Deferasirox and deferiprone', 'deferiprone', 'deferasirox', 'deferiprone versus deferasirox']","['Safety', 'Compliance', 'serum ferritin concentration', 'efficacy and safety', 'occurrence of serious and drug-related adverse events', 'sickle cell disease', 'reversible agranulocytosis', 'reversible renal and urinary disorders']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0010622', 'cui_str': 'Cyprus'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0043832', 'cui_str': 'deferiprone'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0019045', 'cui_str': 'Hemoglobinopathy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0001824', 'cui_str': 'Agranulocytosis'}, {'cui': 'C0042075', 'cui_str': 'Disorder of urinary tract'}]",435.0,0.255378,"In paediatric patients with transfusion-dependent haemoglobinopathies, deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment.","[{'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Maggio', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. Electronic address: aurelio.maggio@villasofia.it.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'First Department of Pediatrics, National and Kapodistriam University of Athens, Athens, Greece.'}, {'ForeName': 'Mariagrazia', 'Initials': 'M', 'LastName': 'Felisi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Reggiardo', 'Affiliation': 'Biostatistics and Data Management Unit, Medi Service, Genoa, Italy.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'El-Beshlawy', 'Affiliation': 'Pediatric Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bejaoui', 'Affiliation': 'Pediatrics and Bone Marrow Transplantation Centre, Tunis, Tunisia.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Sherief', 'Affiliation': 'Pediatrics Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Soteroula', 'Initials': 'S', 'LastName': 'Christou', 'Affiliation': 'Thalassaemia Center, Hospital Archbishop Makarios III, Nicosia, Cyprus.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cosmi', 'Affiliation': 'Clinica Pediatrica, Azienda Ospedaliero Universitaria (AOU) Sassari, Sassari, Italy.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics Group, University College London, London, UK.'}, {'ForeName': 'Giovanni Carlo', 'Initials': 'GC', 'LastName': 'Del Vecchio', 'Affiliation': 'UO Pediatrica B Trambusti, AOU Consorziale Policlinico-Giovanni XXIII, Bari, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Filosa', 'Affiliation': 'UOSD Malattie rare del globulo rosso, AORN A Cardarelli, Napoli, Italy.'}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Cuccia', 'Affiliation': 'UOC Ematologia con Talassemia, Dipartimento di Medicina, AO Civico Di Cristina-Benfratelli, Palermo, Italy.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Hassab', 'Affiliation': 'Department of Pediatrics and Clinical Research Center, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Kreka', 'Affiliation': 'Pediatrics Department, University Hospital Center Mother Teresa, Tirana, Albania.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'DH Talassemia, Ospedale Pediatrico Microcitemico A CAO, AO G Brotzu, Cagliari, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Putti', 'Affiliation': ""Department of Women's and Child's Health (DSDB), University Hospital, Padova, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spino', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Telfer', 'Affiliation': 'Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Tempesta', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vitrano', 'Affiliation': 'Department of Hematology and Rare Diseases, V Cervello, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Yu Chung', 'Initials': 'YC', 'LastName': 'Tsang', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Zaka', 'Affiliation': 'Center of Thalassemia, Hospital Ihsan Cabej, Lushnje, Albania.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Tricta', 'Affiliation': 'ApoPharma, Toronto, ON, Canada.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Bonifazi', 'Affiliation': 'Consorzio per Valutazioni Biologiche e Farmacologiche, Bari-Pavia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ceci', 'Affiliation': 'Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Valenzano, Italy.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30100-9'] 3093,32471477,"Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial.","BACKGROUND More than half of patients with rheumatoid arthritis complain of insomnia, which is predominantly treated with hypnotic drugs. However, cognitive behavioural therapy for insomnia is recommended as the first-line treatment in international guidelines on sleep. Patients with rheumatoid arthritis suffer from debilitating symptoms, such as fatigue and pain, which can also be linked to sleep disturbance. It remains to be determined whether cognitive behavioural therapy for insomnia can be effective in patients with rheumatoid arthritis. The aim of the Sleep-RA trial is to investigate the efficacy of cognitive behavioural therapy for insomnia on sleep and disease-related symptoms in patients with rheumatoid arthritis. The primary objective is to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep efficiency from baseline to week 7 in patients with rheumatoid arthritis. The key secondary objectives are to compare the effect of cognitive behavioural therapy for insomnia relative to usual care on changes in sleep onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms from baseline to week 26 in patients with rheumatoid arthritis. METHODS The Sleep-RA trial is a randomised controlled trial with a two-group parallel design. Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity will be allocated 1:1 to treatment with cognitive behavioural therapy for insomnia or usual care. Patients in the intervention group will receive nurse-led, group-based cognitive behavioural therapy for insomnia once a week for 6 weeks. Outcome assessments will be carried out at baseline, after treatment (week 7) and at follow-up (week 26). DISCUSSION Data on treatment of insomnia in patients with rheumatoid arthritis are sparse. The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis. Because symptoms of rheumatoid arthritis and insomnia have many similarities, we also find it relevant to investigate the secondary effects of cognitive behavioural therapy for insomnia on fatigue, impact of rheumatoid arthritis, depressive symptoms, pain, functional status, health-related quality of life and disease activity. If we find cognitive behavioural therapy for insomnia to be effective in patients with rheumatoid arthritis this will add weight to the argument that evidence-based non-pharmacological treatment for insomnia in rheumatological outpatient clinics is eligible in accordance with the existing international guidelines on sleep. TRIAL REGISTRATION ClinicalTrials.gov: NCT03766100. Registered on 30 November 2018.",2020,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"['patients with rheumatoid arthritis', 'Sixty patients with rheumatoid arthritis, insomnia and low-to-moderate disease activity', 'Patients with rheumatoid arthritis suffer from debilitating symptoms']","['Cognitive behavioural therapy', 'nurse-led, group-based cognitive behavioural therapy', 'cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia or usual care']","['sleep\xa0onset latency, wake after sleep onset, total sleep time, insomnia, sleep quality, fatigue, impact of rheumatoid arthritis and depressive symptoms', 'sleep efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",60.0,0.0802292,The Sleep-RA trial is the first randomised controlled trial to investigate the efficacy of cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis.,"[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Latocha', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark. kristine.marie.latocha@regionh.dk.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Løppenthin', 'Affiliation': 'Department of Oncology, Research unit for Cancer Late Effect, CASTLE, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Jennum', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hetland', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Røgind', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lundbak', 'Affiliation': 'Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Midtgaard', 'Affiliation': 'The University Hospitals Centre for Health Research, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}]",Trials,['10.1186/s13063-020-04282-6'] 3094,32471478,Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial.,"BACKGROUND Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment. Disclosure can lead to rejection and discrimination, but alternatively can also have important advantages that may be necessary to retain employment. Whether disclosure decisions lead to sustainable employment depends on many factors, of which unemployed people themselves can only influence their decision to disclose or not and the way in which they communicate. This study evaluates the cost-effectiveness of an intervention to support unemployed people with MHI in their disclosure decision and communication. METHODS This is a two-armed, clustered, randomized controlled trial with longitudinal design and randomization at organization level. An intervention will be examined, which consists of a disclosure decision aid tool (CORAL.NL) for unemployed people and workplace stigma-awareness training especially designed for employment specialists, which focusses on how to support unemployed people in their disclosure decisions. Participants in the intervention group are unemployed people who receive support from trained employment specialists from organizations allocated to the intervention group, and receive the CORAL.NL decision aid after baseline. The control group consists of unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group. Primary outcomes are: cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI. Secondary outcomes are mental health and wellbeing, stigma and discrimination and work-related factors. Financial income data are collected via the registration systems of Dutch municipalities and Statistics Netherlands, and by questionnaires at baseline, and at 3, 6 and 12 months. DISCUSSION If using a decision aid to decide about disclosure of MHI leads to people finding and retaining employment more often, this study will contribute to lowering healthcare and societal costs. TRIAL REGISTRATION Netherlands Trial Register: NL7798. Registered on 4 June 2019.",2020,"BACKGROUND Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.",['unemployed people with MHI in their disclosure decision and communication'],['unemployed people who receive support as usual from employment specialists from different organizations allocated to the control group'],"['cost-effectiveness of the intervention, e.g. healthcare costs, having employment, days until start of employment, independency of social security, having other forms of employment and decision making about disclosing MHI', 'cost-effectiveness', 'mental health and wellbeing, stigma and discrimination and work-related factors']","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.102735,"BACKGROUND Unemployment rates are higher among people with mental health issues/illness (MHI) than in the general working population, and many of them face the dilemma of whether or not to disclose their MHI when searching for employment.","[{'ForeName': 'K M E', 'Initials': 'KME', 'LastName': 'Janssens', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands. k.m.e.janssens@tilburguniversity.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Weeghel', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'M C W', 'Initials': 'MCW', 'LastName': 'Joosen', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'E P M', 'Initials': 'EPM', 'LastName': 'Brouwers', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}]",Trials,['10.1186/s13063-020-04376-1'] 3095,32471480,Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial.,"BACKGROUND Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this intervention on muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores in this population. METHODS Thirty participants will be randomly distributed between 1) BFR-RT and 2) control (CTRL). Assessments will occur at three time points: before the training intervention (0 W), after 12 weeks (12 W), and at follow-up (24 W). The following variables will be assessed: Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length. The BFR-RT group will undergo 12 weeks of knee extension exercise (1 × 30 repetitions and 3 × 15 repetitions at 20% 1-RM and 50% of total blood flow occlusion pressure), with two sessions per week. Data normality will be assessed using the Shapiro-Wilk test. In case of normal distribution, a one-way repeated measures analysis of variance will be implemented to test for differences in baseline values. A mixed model then will be applied for each dependent variable. In case of non-normal data distribution, a Kruskal-Wallis test will be implemented to test for differences in baseline values. Next, the Friedman test will be used to analyze repeated measures. Within- and between-group effect sizes will be calculated using Cohen's d for each outcome. Finally, the minimal clinically important difference will be analyzed with distribution-based methods. DISCUSSION To our knowledge, this will be the first trial to investigate BFR-RT in patients with cirrhosis and evaluate the effects on neuromuscular parameters, functional performance, disease severity, and quality of life outcomes. TRIAL REGISTRATION Brazilian Clinical Trials Registry (ReBec): RBR-395mfw. Registered on 25 August 2018.",2020,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","['patients with cirrhosis', 'cirrhosis', 'Thirty participants will be randomly distributed between 1']","['BFR-RT and 2) control (CTRL', 'knee extension exercise', 'resistance training with blood flow restriction (BFR-RT', 'Resistance training combined with blood flow restriction']","['muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores', ""repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length"", 'neuromuscular parameters, functional performance, disease severity, and quality of life outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",30.0,0.0870044,"Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis' cross-sectional area, Pennation angle, and fascicle length.","[{'ForeName': 'Sanmy Rocha', 'Initials': 'SR', 'LastName': 'Nóbrega', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Silvana Gama Florencio', 'Initials': 'SGF', 'LastName': 'Chachá', 'Affiliation': 'Department of Medicine, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil.'}, {'ForeName': 'Cleiton Augusto', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos - UFSCar, Rod. Washington Luiz, km 235 - SP 310, São Carlos, SP, CEP 13565-905, Brazil. c.libardi@ufscar.br.'}]",Trials,['10.1186/s13063-020-04410-2'] 3096,32471492,Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial.,"BACKGROUND Benefits to patients from reduced depression have been shown from monitoring progress with patient-reported outcome measures (PROMs) in psychological therapy and mental health settings. This approach has not yet been researched in the United Kingdom for primary care, which is where most people with depression are treated in the United Kingdom. METHODS This is a parallel-group cluster randomised trial with 1:1 allocation to intervention and control. Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria. Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded. The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later. General practitioners are trained in interpreting scores and asked to take them into account in their treatment decisions. Patients are given written feedback on scores and suggested treatments. The primary outcome measure is Depression on the Beck Depression Inventory BDI-II at 12 weeks. Secondary outcomes include BDI-II at 26 weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26 weeks, service use over 26 weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale). The sample includes 676 total participants from 113 practices across three centres. Randomisation is achieved by computerised sequence generation. Blinding is impossible given the nature of the intervention (self-report outcome measures prevent rating bias). Differences at 12 and 26 weeks between intervention and controls in depression, social functioning and quality of life are analysed using linear mixed models, adjusted for socio-demographics, baseline depression, anxiety, and clustering, while including practice as a random effect. Patient satisfaction, quality of life (QALYs) and costs over 26 weeks will be compared between arms. Qualitative process analysis includes interviews with 15-20 GP/NPs and 15-20 patients per arm to reflect trial results and implementation issues, using Normalization Process Theory as a theoretical framework. DISCUSSION If PROMs are helpful in improving patient outcomes for depression even to a small extent, then they are likely to be good value for money, given their low cost. The benefits could be considerable, given that depression is common, disabling, and costly. TRIAL REGISTRATION ISRCTN no: 17299295. Registered 1st October 2018.",2020,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"['Patients who are age 18+ years, with a new episode of depressive disorder/symptoms, meet the inclusion criteria', 'primary care patients with depression (PROMDEP', '676 total participants from 113 practices across three centres', 'Patients with current depression treatment, comorbid dementia/psychosis/substance misuse/suicidal ideas are excluded']",['Patient Health Questionnaire (PHQ-9'],"['Patient satisfaction, quality of life (QALYs) and costs', 'BDI-II at 26\u2009weeks, changes in drug treatments and referrals, social functioning (Work & Social Adjustment Scale) and quality of life (EQ-5D) at 12 and 26\u2009weeks, service use over 26\u2009weeks (modified Client Services Receipt Inventory) to calculate NHS costs, and patient satisfaction at 26\u2009weeks (Medical Informant Satisfaction Scale', 'Depression on the Beck Depression Inventory BDI-II at 12\u2009weeks', 'depression, social functioning and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",,0.232089,The intervention includes the Administration of Patient Health Questionnaire (PHQ-9) as a PROM within 2 weeks of diagnosis and at follow-up 4 weeks later.,"[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK. A.R.Kendrick@soton.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Leydon', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Yao', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, University Road Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, 6th Floor, Maple House, 149 Tottenham Court Rd, London, W1T 7NF, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dewar-Haggart', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Primary Care, Population Sciences, and Medical Education, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dowrick', 'Affiliation': 'Institute of Psychology Health and Society, University of Liverpool, Liverpool, L69 3GL, UK.'}]",Trials,['10.1186/s13063-020-04344-9'] 3097,32475246,Fixation of the short global tissue-sparing hip stem.,"AIMS Short, bone-conserving femoral components are increasingly used in total hip arthroplasty (THA). They are expected to allow tissue-conserving implantation and to render future revision surgery more straightforward but the long-term data on such components is limited. One such component is the global tissue-sparing (GTS) stem. Following the model for stepwise introduction of new orthopaedic implants, we evaluated early implant fixation and clinical outcome of this novel short-stem THA and compared it to that of a component with established good long-term clinical outcome. METHODS In total, 50 consecutive patients ≤ 70 years old with end-stage symptomatic osteo-arthritis were randomized to receive THA with the GTS stem or the conventional Taperloc stem using the anterior supine intermuscular approach by two experienced hip surgeons in two hospitals in the Netherlands. Primary outcome was implant migration. Patients were followed using routine clinical examination, patient reported outcome using Harris Hip Score (HHS), Hip Disability And Osteoarthritis Outcome Score (HOOS), EuroQol five-dimension questionnaire (EQ5D), and Roentgen Stereophotogrammetric Analysis (RSA) at three, six, 12, and 24 months. This study evaluated the two-year follow-up results. RESULTS In addition to the initial migration pattern of distal migration (subsidence, Y-translation) and retroversion (Y-rotation) also exhibited by the Taperloc stem, the GTS stem showed an initial migration pattern of varization (X-translation combined with Z-rotation) and posterior translation (Z-translation). However, all components stabilized aside from one Taperloc stem which became loose secondary to malposition and was later revised. Clinical outcomes and complications were not statistically significantly different with the numbers available. CONCLUSION A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem. Although implant stabilization was achieved, excellent long-term survival similar to that of the Taperloc stem should not be inferred. Especially in the absence of clinically proven relevant improvement, widespread usage should be postponed until long-term safety has been established. Cite this article: Bone Joint J 2020;102-B(6):699-708.",2020,A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem.,"['50 consecutive patients ≤ 70 years old with end-stage symptomatic osteo-arthritis', 'total hip arthroplasty (THA']","['THA with the GTS stem or the conventional Taperloc stem using the anterior supine intermuscular approach by two experienced hip surgeons', 'bone-conserving femoral components', 'Fixation of the short global tissue-sparing hip stem']","['excellent long-term survival', 'Harris Hip Score (HHS), Hip Disability And Osteoarthritis Outcome Score (HOOS), EuroQol five-dimension questionnaire (EQ5D), and Roentgen Stereophotogrammetric Analysis (RSA', 'implant migration', 'extensive initial migration pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0560562', 'cui_str': 'roentgen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",50.0,0.0492984,A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem.,"[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Nieuwenhuijse', 'Affiliation': 'Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, the Netherlands.'}, {'ForeName': 'Stephan B W', 'Initials': 'SBW', 'LastName': 'Vehmeijer', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Nina M C', 'Initials': 'NMC', 'LastName': 'Mathijsen', 'Affiliation': 'Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Stefan B', 'Initials': 'SB', 'LastName': 'Keizer', 'Affiliation': 'Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, the Netherlands.'}]",The bone & joint journal,['10.1302/0301-620X.102B6.BJJ-2019-1026.R2'] 3098,32484534,"Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.","Importance Antibiotic overuse drives antibiotic resistance. Gram-negative bacteremia is a common infection that results in substantial antibiotic use. Objective To compare the clinical effectiveness of C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations 30, 60, and 90 days after treatment initiation. Design, Setting, and Participants Multicenter, noninferiority, point-of-care randomized clinical trial including adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019. Patients and physicians were blinded between randomization and antibiotic discontinuation. Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression. Intervention Randomization in a 1:1:1 ratio to an individualized CRP-guided antibiotic treatment duration (discontinuation once CRP declined by 75% from peak; n = 170), fixed 7-day treatment duration (n = 169), or fixed 14-day treatment duration (n = 165). Main Outcomes and Measures The primary outcome was the clinical failure rate at day 30, defined as the presence of at least 1 of the following, with a non-inferiority margin of 10%: recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause. Secondary outcomes included the clinical failure rate on day 90 of follow-up. Results Among 504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up. Median antibiotic duration in the CRP group was 7 (interquartile range, 6-10; range, 5-28) days; 34 of the 164 patients (21%) who completed the 30-day follow-up had protocol violations related to treatment assignment. The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001). By day 90, clinical failure occurred in 10 of 143 patients (7.0%) in the CRP group, 16 of 151 (10.6%) in the 7-day group, and 16 of 153 (10.5%) in the 14-day group. Conclusions and Relevance Among adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment were noninferior to fixed 14-day treatment. However, interpretation is limited by the large noninferiority margin compared with the low observed event rate, as well as low adherence and wide range of treatment durations in the CRP-guided group. Trial Registration ClinicalTrials.gov Identifier: NCT03101072.",2020,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","['Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression', 'With Uncomplicated Gram-Negative Bacteremia', 'Patients', 'adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019', 'adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment', '504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up']","['individualized CRP-guided antibiotic treatment duration (discontinuation once CRP', 'C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations', 'C-Reactive Protein-Guided Antibiotic']","['clinical failure rate', 'Median antibiotic duration', 'clinical failure rate on day 90 of follow-up', '30-Day Clinical Failure Rate', 'recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause', 'clinical failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3160894', 'cui_str': 'Complicated infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3203360', 'cui_str': 'Suppuration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",504.0,0.162586,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'von Dach', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Werner C', 'Initials': 'WC', 'LastName': 'Albrich', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Brunel', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Prendki', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cuvelier', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Flury', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lemmenmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rossel', 'Affiliation': 'Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Bochud', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}]",JAMA,['10.1001/jama.2020.6348'] 3099,32482147,Comparative measurement properties of constant work rate cycling and the endurance shuttle walking test in COPD: the TORRACTO ® clinical trial.,"BACKGROUND Exercise tolerance is an important endpoint in chronic obstructive pulmonary disease (COPD) clinical trials. Little is known about the comparative measurement properties of constant work rate cycle ergometry (CWRCE) and the endurance shuttle walking test (ESWT). The objective of this sub-analysis of the TORRACTO ® study was to directly compare the endurance measurement properties of CWRCE and ESWT in patients with COPD in a multicentre, multinational setting. We predicted that both tests would be similarly reliable, but that the ESWT would be more responsive to bronchodilation than CWRCE. METHODS This analysis included 151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily placebo, tiotropium/olodaterol (T/O) 2.5/5 μg or T/O 5/5 μg. Reproducibility was assessed by comparing their respective performance at baseline and week 6 in the placebo group. Responsiveness to bronchodilation was assessed by comparing endurance time at week 6 with T/O with baseline values and placebo. The locus of symptom limitation and end-exercise Borg scales for breathing and leg discomfort for both tests were also analysed. RESULTS The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84). More patients were limited by breathing discomfort during the ESWT than during CWRCE, whereas more patients were limited by leg discomfort or breathing/leg discomfort during CWRCE than the ESWT ( p  <0.0001). Both tests were responsive to bronchodilator treatment: there was a 19% increase in endurance time from baseline at week 6 ( p  = 0.0006) assessed with CWRCE, and a 20% increase in endurance time assessed with ESWT ( p  = 0.0013). CONCLUSIONS Both exercise tests performed well in a multicentre clinical trial. Although the locus of symptom limitation differed between the two tests, both were reliable and responsive to bronchodilation. For future clinical trials, the choice of test should depend on the study requirements. CLINICALTRIALS.GOV IDENTIFIER NCT01525615. The reviews of this paper are available via the supplemental material section.",2020,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"['chronic obstructive pulmonary disease (COPD', 'patients with COPD in a multicentre, multinational setting', 'COPD', '151 patients who performed CWRCE and ESWT at baseline and week 6 after receiving once-daily']","['ESWT', 'endurance shuttle walking test', 'placebo, tiotropium/olodaterol (T/O) 2.5/5\u2009μg or T', 'placebo']","['endurance time assessed with ESWT', 'endurance time', 'Reproducibility', 'leg discomfort or breathing/leg discomfort', 'breathing discomfort']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}, {'cui': 'C0859235', 'cui_str': 'Leg discomfort'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",151.0,0.220765,The intraclass correlation coefficients for CWRCE and ESWT were 0.56 [95% confidence interval (CI) 0.37-0.71] and 0.75 (95% CI 0.63-0.84).,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Research Centre, Institut universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, G1V 4G5, Canada.'}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hamilton', 'Affiliation': 'Medical Department, Boehringer Ingelheim, Burlington, ON, Canada.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Rehabilitation Clinical Trial Centre, Los Angeles Biomedical Research Institute at Harbour-UCLA Medical Centre, Torrance, CA, USA.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620926858'] 3100,32469184,"Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer.","BACKGROUND Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported. METHODS In this double-blind, phase 3 trial, men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy were randomly assigned (in a 2:1 ratio) to receive enzalutamide at a dose of 160 mg or placebo once daily. Overall survival was assessed with a group sequential testing procedure and an O'Brien-Fleming-type alpha-spending function. RESULTS As of October 15, 2019, a total of 288 of 933 patients (31%) in the enzalutamide group and 178 of 468 (38%) in the placebo group had died. Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001). The exposure-adjusted rate of adverse events of grade 3 or higher was 17 per 100 patient-years in the enzalutamide group and 20 per 100 patient-years in the placebo group. Adverse events in the enzalutamide group were consistent with those previously reported for enzalutamide; the most frequently reported events were fatigue and musculoskeletal events. CONCLUSIONS Enzalutamide plus androgen-deprivation therapy resulted in longer median overall survival than placebo plus androgen-deprivation therapy among men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level. The risk of death associated with enzalutamide was 27% lower than with placebo. Adverse events were consistent with the established safety profile of enzalutamide. (Funded by Pfizer and Astellas Pharma; PROSPER ClinicalTrials.gov number, NCT02003924.).",2020,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","['men who had nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer', 'men with nonmetastatic, castration-resistant prostate cancer (defined on the basis of conventional imaging and a PSA doubling time of ≤10 months) who were continuing to receive androgen-deprivation therapy']","['Enzalutamide plus androgen-deprivation therapy', 'placebo plus androgen-deprivation therapy', 'enzalutamide', 'enzalutamide at a dose of 160 mg or placebo', 'placebo']","['Median overall survival', 'risk of death', 'Adverse events', 'Overall survival', 'died', 'median overall survival', 'metastasis-free survival', 'Enzalutamide and Survival', 'fatigue and musculoskeletal events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.755206,"Median overall survival was 67.0 months (95% confidence interval [CI], 64.0 to not reached) in the enzalutamide group and 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death, 0.73; 95% CI, 0.61 to 0.89; P = 0.001).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Penson', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Ubirajara', 'Initials': 'U', 'LastName': 'Ferreira', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Madziarska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Kolinsky', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Daniel I G', 'Initials': 'DIG', 'LastName': 'Cubero', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Noerby', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Zohren', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2003892'] 3101,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities. METHODS Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response. RESULTS We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus. LIMITATIONS Only young Chinese males without any trauma experience were recruited in this study. CONCLUSIONS The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123'] 3102,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults. METHODS Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual. RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)]. DISCUSSION The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054'] 3103,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD. METHODS Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention. RESULTS The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected. LIMITATIONS The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study. CONCLUSIONS Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007'] 3104,32470022,Peripheral endothelial function can be improved by daily consumption of water containing over 7 ppm of dissolved hydrogen: A randomized controlled trial.,"BACKGROUND Measurement of the reactive hyperemia index (RHI) using peripheral arterial tonometry (PAT) has shown benefits in the evaluation of vascular endothelial function and prediction of cardiovascular disease prognosis. Thus, it is important to examine the factors that promote the RHI. In this study, we aimed to investigate the effect of molecular hydrogen (H2) on reactive hyperemia-PAT of the small arteries of fingers in healthy people. METHODS To determine the efficacy of H2 for improving peripheral vascular endothelial function, water containing high H2 concentrations was administered to participants, and the Ln_RHI was measured in the finger vasculature. Sixty-eight volunteers were randomly divided into two groups: a placebo group (n = 34) that drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water). The Ln_RHI was measured before ingesting the placebo or high H2 water, 1 h and 24 h after the first ingestion, and 14 days after daily ingestion of high H2 water or the placebo. The mixed effects model for repeated measures was used in data analysis. RESULTS The high H2 group had a significantly greater improvement in Ln_RHI than the placebo group. Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks. CONCLUSIONS Daily consumption of high H2 water improved the endothelial function of the arteries or arterioles assessed by the PAT test. The results suggest that the continuous consumption of high H2 water contributes to improved cardiovascular health.",2020,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks. ","['Sixty-eight volunteers', 'healthy people']","['molecular hydrogen (H2', 'peripheral arterial tonometry (PAT', 'drank molecular nitrogen (N2)-containing water and a high H2 group (n = 34) that drank high H2 water (containing 7 ppm of H2: 3.5 mg H2 in 500-mL water', 'placebo']","['endothelial function', 'Ln_RHI', 'cardiovascular health', 'peripheral vascular endothelial function, water containing high H2 concentrations', 'Peripheral endothelial function']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",68.0,0.102059,"Ln_RHI improved by 22.2% (p<0.05) at 24 h after the first ingestion of high H2 water and by 25.4% (p<0.05) after the daily consumption of high H2 water for 2 weeks. ","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kawamoto', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kasumi', 'Initials': 'K', 'LastName': 'Matsuno', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Genki', 'Initials': 'G', 'LastName': 'Ishihara', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Takamichi', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Department of Rheumatology, Orthopaedic Surgery and Health Care, Huis Ten Bosch Satellite H2 Clinic Hakata, Hakata-ku, Fukuoka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Komori', 'Affiliation': 'Anicom Speciality Medical Institute, Shinjuku-ku, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0233484'] 3105,32470089,A pilot randomized trial of incentive strategies to promote HIV retesting in rural Uganda.,"BACKGROUND Retesting for HIV is critical to identifying newly-infected persons and reinforcing prevention efforts among at-risk adults. Incentives can increase one-time HIV testing, but their role in promoting retesting is unknown. We sought to test feasibility and acceptability of incentive strategies, including commitment contracts, to promote HIV retesting among at-risk adults in rural Uganda. METHODS At-risk HIV-negative adults were enrolled in a pilot trial assessing feasibility and acceptability of incentive strategies to promote HIV retesting three months after enrollment. Participants were randomized (1:1:3) to: 1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit) upon retesting or lost if participants failed to retest. Contracts sought to promote retesting by leveraging loss aversion and addressing present bias via pre-commitment. Outcomes included acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake. RESULTS Of 130 HIV-negative eligible adults, 123 (95%) enrolled and were randomized: 74 (60%) to commitment contracts, 25 (20%) to standard incentives, and 24 (20%) to no incentive. Of contract participants, 69 (93%) made deposits. Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups. CONCLUSION In a randomized trial of strategies to promote HIV retesting among at-risk adults in Uganda, incentive strategies, including commitment contracts, were feasible and had high acceptability. Our findings suggest use of incentives for HIV retesting merits further comparison in a larger trial. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT:02890459.",2020,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups. ","['risk adults in rural Uganda', 'At-risk HIV-negative adults', '130 HIV-negative eligible adults, 123 (95%) enrolled', 'HIV retesting in rural Uganda']",['1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit'],"['acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake', 'HIV: uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",130.0,0.175444,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups. ","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Mbarara, Uganda.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Marson', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Devy M', 'Initials': 'DM', 'LastName': 'Emperador', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0233600'] 3106,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients. PATIENTS AND METHODS This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24. RESULTS Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG. CONCLUSION Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108'] 3107,32471382,NORAD01-GRECCAR16 multicenter phase III non-inferiority randomized trial comparing preoperative modified FOLFIRINOX without irradiation to radiochemotherapy for resectable locally advanced rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE trial).,"BACKGROUND Preoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT. METHODS This study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574. DISCUSSION The choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients. TRIAL REGISTRATION ClinicalTrials.gov NCT03875781 (March 15, 2019). Version 1.1.",2020,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"['rectal cancer patients', 'Patients with mid or low resectable LARC', 'patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N']","['preoperative modified FOLFIRINOX without irradiation to radiochemotherapy', 'Preoperative radiochemotherapy (RCT', 'RCT', 'NORAD01-GRECCAR16', 'cT3N0 or cT1-T3N+ with circumferential resection margin [CRM]\u2009', 'Cap50 intensified-modulated radiotherapy', 'chemotherapy']","['3-year progression-free survival (PFS', 'treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.14794,The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Brouquet', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France. antoine.brouquet@aphp.fr.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': ""Service d'Oncologie Digestive, Hôpital de la Pitié Salpétrière, Assistance Publique, Hôpitaux de Paris, Paris, 75013, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': 'Service de Radiothérapie, Hôpital Tenon, Assistance Publique, Hôpitaux de Paris, Paris, 75020, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Karoui', 'Affiliation': 'Service de Chirurgie Digestive, Hôpital Européen Georges Pompidou, Assistance Publique, Hôpitaux de Paris, Paris, 75015, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Artru', 'Affiliation': ""Centre d'oncologie Jean Mermoz, Lyon, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Service de Chirurgie Digestive, CHU Amiens, Amiens, 60000, France.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefèvre', 'Affiliation': 'Service de Chirurgie Générale et Digestive, Hôpital Saint Antoine, Assistance Publique, Hôpitaux de Paris, Paris, 75012, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Unité de recherche clinique CHU, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, CHU Lille, Lille, 59000, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique Paris VII, Assistance Publique, Hôpitaux de Paris, Paris, 75010, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Benoist', 'Affiliation': 'Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre, Groupe Hospitalier Universitaire Paris Sud, Assistance Publique, Hôpitaux de Paris, 63, rue Gabriel Péri, Le Kremlin Bicetre, 94275, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-06968-1'] 3108,32471387,Developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: a two-year interim report of a randomized single-blind multicenter controlled trial.,"BACKGROUND Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach. METHODS We conducted a randomized, single-blind controlled trial to assess a novel intervention: the ""Developmental and Sequenced One-to-One Intervention (DS1-EI)"". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months. RESULTS At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups. CONCLUSIONS The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended. TRIAL REGISTRATION ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.",2020,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"['autism spectrum disorder and intellectual disability', 'Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study', 'children with ID and ASD and in France', '9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID', 'Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID', '72 participants were randomized']","['DS1-EI', 'http://www.anzctr.org.au', 'Developmental and sequenced one-to-one educational intervention (DS1-EI', 'Developmental and Sequenced One-to-One Intervention (DS1-EI', 'TAU']","['feasibility and efficacy', 'Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS', 'Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales'}, {'cui': 'C0077959', 'cui_str': 'VAB II protocol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0055633', 'cui_str': 'Chromogranin A'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",72.0,0.0655832,The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Tanet', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Hubert-Barthelemy', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'Marie-Noëlle', 'Initials': 'MN', 'LastName': 'Clément', 'Affiliation': 'Hôpital de jour André Boulloche, association Cerep-Phymentin, 56 rue du Faubourg Poissonnière, 75010, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Soumille', 'Affiliation': ""Association Régionale pour l'Intégration, 26 rue Saint Sébastien, 13006, Marseille, France.""}, {'ForeName': 'Graciela C', 'Initials': 'GC', 'LastName': 'Crespin', 'Affiliation': ""Association Programme de Recherche et d'Etudes sur l'Autisme, 7, square Dunois, 75013, Paris, France.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Pellerin', 'Affiliation': ""Département de Psychiatrie de l'Enfant et de l'Adolescent, APHP, Groupe Hospitalier Pitié-Salpêtrière et Sorbonne Université, 75013, Paris, France.""}, {'ForeName': 'François-André', 'Initials': 'FA', 'LastName': 'Allaert', 'Affiliation': 'CEN Biotech, Parc Mazen-Sully, Zone des biotechnologies, Impasse Françoise Dolto, 21000, Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France. david.cohen@aphp.fr.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Saint-Georges', 'Affiliation': 'Institut des Systèmes Intelligents et de Robotiques, Sorbonne Université, 75005, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02156-z'] 3109,32471390,Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.,"BACKGROUND It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment. METHODS The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ≥5 are randomized to the intervention or control group while patients scoring ≤4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2 weeks and 3, 6, 9 and 12 months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated. DISCUSSION This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice. TRIAL REGISTRATION ClinicalTrials.gov NCT03434717. Registered February 15, 2018.",2020,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"['Women with newly diagnosed BC', 'women suffer from negative consequences following breast cancer (BC', 'primary breast cancer treatment']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],[],,0.127976,The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period.,"[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Olsson Möller', 'Affiliation': 'Department of Nursing and Integrated Health Sciences, Faculty of Health Sciences, Kristianstad University, Kristianstad, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Clinical Sciences Lund, Surgery, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malmström', 'Affiliation': 'Department of Health Sciences, Lund University, Box 157, 221 00, Lund, Sweden. marlene.malmstrom@med.lu.se.'}]",BMC cancer,['10.1186/s12885-020-06815-3'] 3110,32471400,"Effectiveness of a family intervention on health-related quality of life-a healthy generation, a controlled pilot trial.","BACKGROUND Physical activity is associated with better health, but knowledge about health promoting interventions, including physical activity for families in disadvantaged areas and the impact on health-related quality of life (HRQOL) is sparse. The aim of this study was to assess HRQOL in children and their parents after participation in the programme ""A Healthy Generation"". METHODS The programme is delivered in socioeconomically disadvantaged areas in Sweden and offers physical activity and a healthy meal or fruit twice a week from August to May to families with children in grade 2. Children (n = 67), aged 8-9 years, and their parents (n = 90) participated in this controlled study conducted in four schools, two control and two intervention schools. HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively. Analyses of covariance (ANCOVAs), linear regression and Pearson's correlation were conducted. RESULTS There were no significant differences between intervention and control in HRQOL among children or adults after the intervention. However, in a subgroup of children (n = 20) and adults (n = 29) with initial low HRQOL scores at baseline, there was a significant difference between the intervention group and control group after the intervention (children (total score): p = 0.02; adults (social domain) p = 0.04). Furthermore, within the intervention group, there was a significant relationship between level of participation in ""A Healthy Generation"" and the physical domain of HRQOL among girls (r = 0.44, p = 0.01), but not boys (r = - 0.07, p = 0.58). CONCLUSION Participation in the programme ""A Healthy Generation"" did not show a significant intervention effect on HRQOL in general. However, the findings suggest that HRQOL may be increased for children and adults with low HRQOL in disadvantaged areas. This knowledge can contribute to the development of health promoting interventions in such areas, and to more equitable health. TRIAL REGISTRATION ISRCTN ISRCTN11660938. Retrospectively registered 23 September 2019.",2020,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","['children and their parents after participation in the programme ""A Healthy Generation', 'children and adults with low HRQOL in disadvantaged areas', 'Children (n\u2009=\u200967), aged 8-9\u2009years, and their parents (n\u2009=\u200990) participated in this controlled study conducted in four schools, two control and two intervention schools']",['family intervention'],"['HRQOL', 'Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale', 'level of participation in ""A Healthy Generation"" and the physical domain of HRQOL', 'health-related quality of life-a healthy generation', 'initial low HRQOL scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0628145,"HRQOL of children and adults was assessed at baseline and follow-up after the intervention with the Pediatric Quality of Life Inventory (PedsQL) 4.0 and the Gothenburg Quality of Life scale, respectively.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Susanne.andermo@ki.se.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Hedby', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, Stockholm, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC public health,['10.1186/s12889-020-08895-z'] 3111,32487236,"A randomized, crossover comparison of ketamine and electroconvulsive therapy for treatment of major depressive episodes: a Canadian biomarker integration network in depression (CAN-BIND) study protocol.","BACKGROUND Recent evidence underscores the utility of rapid-acting antidepressant interventions, such as ketamine, in alleviating symptoms of major depressive episodes (MDE). However, to date, there have been limited head-to-head comparisons of intravenous (IV) ketamine infusions with other antidepressant treatment strategies in large randomized trials. This study protocol describes an ongoing multi-centre, prospective, randomized, crossover, non-inferiority trial comparing acute treatment of individuals meeting diagnostic criteria for a major depressive episode (MDE) with ketamine and electroconvulsive therapy (ECT) on efficacy, speed of therapeutic effects, side effects, and health care resource utilization. A secondary aim is to compare a 6-month maintenance strategy for ketamine responders to standard of care ECT maintenance. Finally, through the measurement of clinical, cognitive, neuroimaging, and molecular markers we aim to establish predictors and moderators of treatment response as well as treatment-elicited effects on these outcomes. METHODS Across four participating Canadian institutions, 240 patients with major depressive disorder or bipolar disorder experiencing a MDE are randomized (1:1) to a course of ECT or racemic IV ketamine (0.5 mg/kg) administered 3 times/week for 3 or 4 weeks. Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) crossover to receive the alternate treatment. Responders during the randomization or crossover phases then enter the 6-month maintenance phase during which time they receive clinical assessments at identical intervals regardless of treatment arm. ECT maintenance follows standard of care while ketamine maintenance involves: weekly infusions for 1 month, then bi-weekly infusions for 2 months, and finally monthly infusions for 3 months (returning to bi-weekly in case of relapse). The primary outcome measure is change in MADRS scores after randomized treatment as assessed by raters blind to treatment modality. DISCUSSION This multi-centre study will help identify molecular, imaging, and clinical characteristics of patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy. In addition to informing clinical practice and influencing health care delivery, this trial will add to the robust platform and database of CAN-BIND studies for future research and biomarker discovery. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT03674671. Registered September 17, 2018.",2020,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"['individuals meeting diagnostic criteria for a major depressive episode (MDE) with', 'major depressive episodes', 'patients with treatment-resistant and/or severe MDEs who would benefit most from either type of therapeutic strategy', '240 patients with major depressive disorder or bipolar disorder experiencing a MDE']","['ketamine and electroconvulsive therapy', 'ketamine and electroconvulsive therapy (ECT', 'ketamine', 'ECT or racemic IV ketamine']","['Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'change in MADRS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",240.0,0.221186,Non-responders (< 50% improvement in Montgomery-Åsberg Depression Rating Scale [MADRS] scores),"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Jaworska', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kamler', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Blier', 'Affiliation': 'Montfort Hospital, 713 Montreal Rd, Ottawa, ON, K1K 0T2, Canada.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Foster', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hassel', 'Affiliation': 'Department of Psychiatry and Mathison Centre for Mental Health Research and Education, Cumming School of Medicine, University of Calgary, 3330 Hospital Dr NW, Calgary, AB, T2N 4N1, Canada.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Ho', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McMurray', 'Affiliation': 'Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Moazamigoudarzi', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Franca M', 'Initials': 'FM', 'LastName': 'Placenza', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Richard-Devantoy', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rotzinger', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Turecki', 'Affiliation': 'McGill University, 845 Rue Sherbrooke O, Montréal, QC, H3A 0G4, Canada.'}, {'ForeName': 'Gustavo H', 'Initials': 'GH', 'LastName': 'Vazquez', 'Affiliation': ""Department of Psychiatry, Queen's University, Providence Care Hospital, 752 King Street West, Postal Bag 603, Kingston, ON, K7L 7X3, Canada.""}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': 'University Health Network, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""The Royal's Institute of Mental Health Research, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC psychiatry,['10.1186/s12888-020-02672-3'] 3112,32487243,Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial.,"BACKGROUND According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule. OBJECTIVES To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain. METHODS This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity) were evaluated before and after the session using a numerical pain scale, algometer, and a force platform. For all outcomes, multiple mixed 2 (group) × 2 (time) ANOVAs were performed. RESULTS For the subjective pain intensity, only time was significant as a main effect, where pre-intervention presented a greater value then post-intervention (F [1.44] = 4.377; p = 0.042; r = 0.30). For the pressure pain threshold no significant effect was found. For the postural control parameters, as a main effect, only the ellipse area was significantly greater in the control group (F [1.44] = 6.760; p = 0.013; effect size = 0.36). CONCLUSIONS There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure. No effect of HVLA lumbar manipulation was identified for postural control variables in either the intervention or control groups. TRIAL REGISTRATION The study was registered at ClinicalTrials.gov under the number NCT02312778, registered at 14 September 2014.",2020,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","['low back pain patients', '24 participants were randomly distributed into', 'individuals with nonspecific low back pain']","['high-velocity low-amplitude (HVLA) manipulation', 'HVLA lumbar manipulation', 'lumbar spine manipulation', 'control (simulated manipulation) and intervention (HVLA lumbar manipulation']","['pain sensitivity and postural control', 'pain and postural control parameters', 'subjective pain intensity', 'primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected gravity', 'numerical pain scale, algometer, and a force platform']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0600578', 'cui_str': 'Lumbar Manipulation'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]",24.0,0.116324,"There was a reduction in subjective pain intensity, evaluated using a numerical scale, in both the intervention and control groups immediately after the intervention, suggesting that the spinal manipulation had a similar effect to the placebo procedure.","[{'ForeName': 'Jefferson', 'Initials': 'J', 'LastName': 'Fagundes Loss', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil. jefferson.loss@ufrgs.br.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza da Silva', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Iã', 'Initials': 'I', 'LastName': 'Ferreira Miranda', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Groisman', 'Affiliation': 'Instituto Brasileiro de Osteopatia, Porto Alegre, Brazil.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Santiago Wagner Neto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}, {'ForeName': 'Catiane', 'Initials': 'C', 'LastName': 'Souza', 'Affiliation': 'Faculdade Social da Bahia, Salvador, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Tarragô Candotti', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Escola de Educação Física, Fisioterapia e Dança, Felizardo, 750 - LAPEX Building, Porto Alegre, RS, 90690-200, Brazil.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00316-7'] 3113,32469920,Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation.,"INTRODUCTION Simulation is a powerful tool for training and evaluating clinicians. However, few studies have examined the consistency of actor performances during simulation based medical education (SBME). The Simulated Communication with ICU Proxies trial (ClinicalTrials.gov NCT02721810) used simulation to evaluate the effect of a behavioral intervention on physician communication. The purpose of this secondary analysis of data generated by the quality assurance team during the trial was to assess how quality assurance monitoring procedures impacted rates of actor errors during simulations. METHODS The trial used rigorous quality assurance to train actors, evaluate performances, and ensure the intervention was delivered within a standardized environment. The quality assurance team evaluated video recordings and documented errors. Actors received both timely, formative feedback and participated in group feedback sessions. RESULTS Error rates varied significantly across three actors (H(2) = 8.22, p = 0.02). In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). CONCLUSIONS Rigorous quality assurance procedures may help ensure consistent actor performances during SBME.",2020,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). ",[],"['Actor feedback and rigorous monitoring', 'behavioral intervention']","['incidence of actor error over time, and errors', 'Error rates']",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0672195,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42). ","[{'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Abshire', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Teply', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States of America.'}, {'ForeName': 'Arun L', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': ""Division of Pediatric Palliative Medicine, Prisma Health Children's Hopsital - Upstate, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, United States of America.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0233538'] 3114,32469922,The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression.,"BACKGROUND Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation. METHODS Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff. RESULTS Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety. CONCLUSIONS A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.",2020,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"['people with complex anxiety and depression in secondary mental health services', 'people with complex anxiety or depression', 'Forty participants were recruited in four months from 65 eligible potential participants asked', 'people with mental health problems', 'adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services', 'Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the']","['Community Navigator programme over six months in addition to routine care (n = 30); or routine care', 'Community Navigator programme']","['Acceptability and feasibility', 'loneliness and depression and anxiety', 'effectiveness and cost-effectiveness', 'loneliness, depression, other clinical and social outcomes and service use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",40.0,0.205116,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frerichs', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Stefanidou', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Chhapia', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Chipp', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Prisha', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shorten', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giorgalli', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Terhune', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0233535'] 3115,32469946,Training specificity performing single-joint vs. multi-joint resistance exercises among physically active females: A randomized controlled trial.,"Resistance-training of the lower limbs can be performed using exercises moving one (single-joint exercises) or several joints (multi-joint exercises). This study compared the effects of training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback) on dynamic and isometric strength and the transferability of dynamic strength between exercises. Fifty-three physically active women were randomized to a multi-joint (MJ) training group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20), single-joint (SJ) training group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15). The training groups participated in an 8-week supervised single- or multi-joint lower limb training consisting of 18 sessions. Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction in the three exercises were assessed, along with electromyography of the superficial quadriceps muscles. Improvements in all dynamic exercises were greatest after training the specific exercises (ES = 1.26-2.14, P<0.001-0.025) and all were greater in the training groups than in the CON group (ES = 1.43-3.31, P<0.001-0.021). The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002). However, leg press and leg extension strength improved similarly in the MJ group (ES = 0.54, P = 0.072). All strength and electromyographic measures remained unchanged in the CON group (ES = 0.00-0.44, P = 0.412-0.966). Improved dynamic strength in leg press, kickback and leg extension is best attained by training the specific exercises, but both training modalities can improve strength across all exercises.",2020,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","['group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15', 'Fifty-three physically active women', 'group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20', 'physically active females']","['multi-joint (MJ) training', 'Training specificity performing single-joint vs. multi-joint resistance exercises', 'Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction', 'single-joint (SJ) training', 'SJ', '8-week supervised single- or multi-joint lower limb training consisting of 18 sessions', 'training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback']","['6RM in leg extension and kickback', 'dynamic strength in leg press, kickback and leg extension', 'leg press 6RM', 'All strength and electromyographic measures', 'leg press and leg extension strength']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556502', 'cui_str': 'Lower limb training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.0304002,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","[{'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Aril Hagen', 'Initials': 'AH', 'LastName': 'Ravnøy', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0233540'] 3116,32471404,Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,"BACKGROUND Children's health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls. METHODS The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention (n = 52) and control (n = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes. RESULTS A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22). Overall there were 36.4% improvement for knowledge (η p 2  = 0.21), 53.2% for the skills (η p 2  = 0.25), 19.5% for the self-efficacy (η p 2  = 0.11), and 25.6% for the beliefs (η p 2  = 0.14) scores from baseline to 6 months' follow-up assessments among the intervention group (p < 0.001). The results also showed a significant interaction effect between group and time. CONCLUSION The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies. TRIAL REGISTRATION Current Controlled Trials IRCT20180528039885N1, 30th Oct 2018, 'Prospectively registered'. https://www.irct.ir/trial/31534.",2020,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","['104 schoolchildren aged 11\u2009±\u20091.0\u2009years', 'spine-related behavior among pupils']","['theory-based back care intervention', 'six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing', 'educational program']","['rate of backache', 'knowledge, skills, self-efficacy, beliefs, and behavior', 'knowledge', 'knowledge, skills, beliefs, and self-efficacy']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",104.0,0.0707787,"A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups (F = 78.865, p < 0.001, η p 2  = 0.22).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-08566-z'] 3117,32471423,Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.,"BACKGROUND The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD. METHODS 207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 μg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 μg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV 1 ) < 50% predicted, or FEV 1  < 80% predicted and ≥ 2 moderate or 1 severe exacerbations in the prior year. The primary endpoint in both trials was weighted mean change from baseline (wmCFB) in 0-24-h FEV 1 at Week 12. Secondary endpoints included CFB in trough FEV 1 at Day 84 and 85. Other endpoints included serial FEV 1 and health status outcomes at Week 12. Safety was evaluated descriptively. RESULTS The modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1 at Week 12 (Study 207608 treatment difference [95% confidence interval]: 15 mL [- 13, 43]; Study 207609: 11 mL [- 20, 41]). FF/UMEC/VI improved trough FEV 1 CFB versus BUD/FOR+TIO at Day 84 and 85 (Day 85 treatment difference: Study 207608: 38 mL [10, 66]; Study 207609: 51 mL [21, 82]) and FEV 1 at 12 and 24 h post-morning dose at Week 12 in both studies. No treatment differences were seen in health status outcomes. Safety profiles were similar between treatments; pneumonia occurred in 7 (< 1%) patients with FF/UMEC/VI and 9 (1%) patients with BUD/FOR+TIO, across both studies. CONCLUSIONS FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV 1 at Week 12 in patients with COPD. Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen. TRIAL REGISTRATION GSK (207608/207609; NCT03478683/NCT03478696).",2020,"Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen. ","['207608 and 207609 were Phase IV', 'Study 207608: 38\u2009mL', '720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732', '10, 66]; Study 207609: 51\u2009mL [21, 82]) and FEV 1 at 12 and 24\u2009h post-morning dose at Week 12 in both studies', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD: lung function and health status']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25\u2009μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12\u2009μg via metered-dose inhaler plus once-daily tiotropium', 'inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple therapy', 'Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy', 'single- with multiple-inhaler ICS/LAMA/LABA combination']","['symptomatic COPD and forced expiratory volume', 'health status outcomes', 'CFB in trough FEV', 'weighted mean change from baseline (wmCFB', 'Safety profiles', 'FF/UMEC/VI improved trough', 'pneumonia', 'serial FEV 1 and health status outcomes']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}]",,0.691451,"Greater improvements in trough and serial FEV 1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen. ","[{'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Corbridge', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Dorais', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fogarty', 'Affiliation': 'Spartanburg Medical Research, Spartanburg, SC, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, Middlesex, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sciurba', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Stiegler', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center and Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA. bernstdd@ucmail.uc.edu.'}]",Respiratory research,['10.1186/s12931-020-01360-w'] 3118,32471469,Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol.,"BACKGROUND Intimate partner violence (IPV) is a leading threat to women's health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya. METHODS A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman's inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group. DISCUSSION Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited. TRIAL REGISTRATION Pan African Clinical Trial Registry approval received 25 April 2018 (PACTR201804003321122); retrospectively registered.",2020,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","['Intimate partner violence (IPV', 'women in low and middle income country settings', 'women reporting IPV or fear of partner and living in an urban settlement']",['community-partnered\xa0technology-based IPV intervention'],"['safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",,0.147335,"In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities.","[{'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Decker', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA. mdecker@jhu.edu.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Wood', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'S Rachel', 'Initials': 'SR', 'LastName': 'Kennedy', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Zaynab', 'Initials': 'Z', 'LastName': 'Hameeduddin', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tallam', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Akumu', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Wanjiru', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Asira', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Omondi', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Otieno', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Mwiti', 'Affiliation': 'Ujamaa-Africa, Mashinani Department, Nairobi, Kenya.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, USA.'}]",BMC public health,['10.1186/s12889-020-08901-4'] 3119,32471476,NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial.,"BACKGROUND The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal. METHODS We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N 1  = 200) and prediabetes (N 2  = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. Outcomes will be analyzed on an intention-to-treat basis. DISCUSSION The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context. TRIAL REGISTRATION ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.",2020,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context. ","['for people with Diabetes (N 1 \u2009=\u2009200) and prediabetes (N 2 \u2009=\u20091036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts', 'people with Diabetes and prediabetes (NUCOD) in Nepal']","['NUCOD program', 'NUrse-led COntinuum of care']","['glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",,0.128419,"The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context. ","[{'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rubee', 'Initials': 'R', 'LastName': 'Dev', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts, Boston, MA, USA.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pushpanjali', 'Initials': 'P', 'LastName': 'Shakya', 'Affiliation': 'Department of Community Medicine, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Prabin Raj', 'Initials': 'PR', 'LastName': 'Shakya', 'Affiliation': 'College of Dentistry, Biomedical Knowledge Engineer Lab, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Sun Yat-sen University Global Health Institute (SGHI), Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Biraj Man', 'Initials': 'BM', 'LastName': 'Karmacharya', 'Affiliation': 'Department of Community Programs, Kathmandu University School of Medical Sciences, Dhulikhel Hospital, Kavre, Nepal. birajmk@kusms.edu.np.'}]",Trials,['10.1186/s13063-020-04372-5'] 3120,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion. OBJECTIVES The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population. METHODS A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline. RESULTS During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters. CONCLUSION These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983'] 3121,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR. MATERIALS AND METHODS Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices. RESULTS A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01). CONCLUSIONS The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110'] 3122,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels. METHODS Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period. RESULTS Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status. CONCLUSIONS Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143'] 3123,32473649,"The propofol-sparing effect of intravenous lidocaine in elderly patients undergoing colonoscopy: a randomized, double-blinded, controlled study.","BACKGROUND Propofol provides a prominent sedation effect in colonoscopy. However, anesthesia and sedation induced with propofol in the elderly might result in cardiopulmonary complications, especially when it is combined with opoids in the regimen. This study aimed to test the hypothesis that the addition of intravenous lidocaine to propofol-based sedation could decrease the overall propofol requirement in elderly patients during colonoscopy while the procedural sedation satisfaction and the hemodynamic stability were not compromised. METHODS Ninety-two patients undergoing colonoscopy were randomly enrolled into lidocaine+propofol (L + P) group or normal saline+propofol (NS + P) groups. Subjects received intravenous bolus of 1.5 mg/kg lidocaine followed by 4 mg kg - 1  h - 1 lidocaine continuous infusion in L + P group or equivalent volumes of normal saline for boluses and infusion in NS + P group. Anesthesia was induced with 2.5 μg sufentanil followed by injection of 1.2 mg kg - 1 propofol in all patients. A single supplemental bolus of 0.6 mg kg - 1 propofol was administered whenever MOAA/S score > 1 or had body movement during the colonoscopy. The recorded primary endpoints included: the total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol. RESULTS A total of 79 patients were included in the final analysis. Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1  min - 1 ) (P = 0.002). CONCLUSIONS The addition of intravenous lidocaine to propofol-based sedation resulted in a remarked reduction of supplemental propofol in the elderly during colonoscopy. TRIAL REGISTRATION The present clinical trial was registered at http://www.chictr.org.cn on 11th March 2019 (registration No. ChiCTR1900021818).",2020,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1  min - 1 ) (P = 0.002). ","['elderly patients during colonoscopy', 'A total of 79 patients were included in the final analysis', 'Ninety-two patients undergoing colonoscopy', 'elderly patients undergoing colonoscopy']","['lidocaine+propofol (L\u2009+\u2009P) group or normal saline+propofol (NS\u2009+\u2009P', 'lidocaine', 'intravenous lidocaine', 'propofol-based sedation', 'intravenous bolus of 1.5\u2009mg/kg lidocaine', 'lidocaine continuous infusion in L\u2009+\u2009P group or equivalent volumes of normal saline for boluses and infusion in NS\u2009+\u2009P group', 'Propofol', 'propofol']","['calculated ""unit propofol"" infusion rate', 'overall propofol requirement', 'total amount of propofol administered during entire procedure, the supplemental amount of propofol after induction, and the frequencies of boluses of supplemental propofol', 'total amounts of propofol']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",79.0,0.134813,"Compared with NS + P group, the total amounts of propofol (induction plus supplemental) were no significant differences in L + P group; however, the required supplemental propofol was less (69.9 ± 39.2 mg vs. 51.5 ± 38.6 mg) (P = 0.039); the average frequencies of boluses of supplemental propofol given after induction were lower (2.1 ± 1.1 vs. 1.4 ± 0.9) (P = 0.003); the calculated ""unit propofol"" infusion rate was lower (0.18 ± 0.05 vs. 0.14 ± 0.04 mg kg - 1  min - 1 ) (P = 0.002). ","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China.""}, {'ForeName': 'Junzheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesia and Pediatrics, Cincinnati Children Hospital Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Wangning', 'Initials': 'W', 'LastName': 'Shangguan', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, 109 West Xueyuan Road, Wenzhou, 325027, China. sgwning@163.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01049-z'] 3124,32473654,Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol.,"BACKGROUND The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. METHODS This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups. DISCUSSION Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable. TRIAL REGISTRATION Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov.",2020,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. ","['patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles', 'patients undergoing IVF cycles with donor eggs', 'patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study']","['Endometrial scratch vs no intervention', 'endometrial scratching (ES']","['live birth rates', 'clinical pregnancy rate and live birth rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4049214', 'cui_str': 'Endometrial scratching'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",,0.165196,"Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain. izquierdo.alexandra@yahoo.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'de la Fuente', 'Affiliation': 'Human Reproduction Unit, Department of Obstetrics and Gynecology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Spies', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rayward', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'ProcreaTec Fertility Clinic, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lora', 'Affiliation': 'Clinical Research Unit (imas12-CIBERESP). University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Galindo', 'Affiliation': 'Fetal Medicine Unit - Maternal and Child Health and Development Network (Red SAMID-RD12/0026/0016). Department of Obstetrics and Gynecology. University Hospital 12 de Octubre. 12 de Octubre Research Institute (imas12), Complutense University of Madrid, Madrid, Spain.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-02958-0'] 3125,32474302,Lower levels of high-density lipoprotein cholesterol are associated with increased cardiovascular events in patients with acute coronary syndrome.,"BACKGROUND AND AIMS This study aimed to elucidate whether high-density lipoprotein cholesterol (HDL-C) at 3-month follow-up for patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS) could predict cardiac events. METHODS The HIJ-PROPER study was a multicenter, prospective, randomized trial comparing intensive lipid-lowering therapy (pitavastatin + ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy) after ACS. The entire cohort was divided into three groups according to tertiles of HDL-C levels at 3-month follow-up (Group 1, HDL-C ≤43 mg/dL; Group 2, HDL-C >43, <53.6 mg/dL; Group 3; HDL-C ≥53.6 mg/dL). Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization) were compared among the three groups. RESULTS The primary endpoint event occurred in 34.8%, 30.1%, and 24.6% of patients in Groups 1, 2, and 3, respectively, and its incidence was significantly higher in Group 1 than in Group 3 (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.19-1.9; p = 0.001). Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02). These trends remained even after adjustment for baseline characteristics and lipid profiles. Multivariate analysis revealed that lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C at 3-month follow-up were independent predictors of the incidence of primary endpoint. CONCLUSIONS Lower levels of HDL-C at 3-month follow-up are independently associated with higher incidence of cardiovascular events in ACS patients receiving contemporary lipid-lowering therapy.",2020,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","['patients with acute coronary syndrome', 'ACS patients receiving contemporary lipid-lowering therapy', 'patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS']","['intensive lipid-lowering therapy (pitavastatin\xa0+\xa0ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy', 'high-density lipoprotein cholesterol (HDL-C']","['Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization', 'cardiovascular events', 'lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0661322,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","[{'ForeName': 'Mayui', 'Initials': 'M', 'LastName': 'Nakazawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. Electronic address: arashi.hiroyuki@twmu.ac.jp.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.05.005'] 3126,32474427,Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial.,"INTRODUCTION Low anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial. METHODS AND ANALYSIS This will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team, and was vetted in a focus group and semistructured interviews involving patients, caregivers, and healthcare professionals. The primary outcome will be global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), at 6 months after surgery. The treatment effect on global QoL will be modelled using generalised estimating equations. Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP. ETHICS AND DISSEMINATION The Research Ethics Committee (REC) at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) is the overseeing REC for all Quebec sites. They have granted ethical approval (MP-05-2019-1628) for all Quebec hospitals (Jewish General Hospital, McGill University Health Center, CHU de Quebec) and have granted full authorisation to begin research at the Jewish General Hospital. Patient recruitment will not begin at the other Quebec sites until inter-institutional contracts are finalised and feasibility/authorisation for research is granted by their respective REC. The results of this study will be presented at national and international conferences, and a manuscript with results will be submitted for publication in a high-impact peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT03828318; Pre-results.",2020,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP. ","['for rectal cancer', 'low anterior resection syndrome']","['restorative proctectomy', 'LARS patient-centred programme (LPCP']","['symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP', 'global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}]","[{'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.228641,"Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP. ","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Garfinkle', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carmen G', 'Initials': 'CG', 'LastName': 'Loiselle', 'Affiliation': 'Department of Oncology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Liliana G', 'Initials': 'LG', 'LastName': 'Bordeianou', 'Affiliation': 'Section of Colon and Rectal Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'A Sender', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Faria', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Vasilevsky', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sahir R', 'Initials': 'SR', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Division of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Quebec, Canada maryliseboutros@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-035587'] 3127,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045'] 3128,32478917,Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.,"BACKGROUND Palliative care remains suboptimal in end-stage liver disease. AIM To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison. METHODS A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion. RESULTS Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (μmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway. CONCLUSIONS The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation. TRIAL REGISTRATION ISRCTN30697116, date assigned: 07/10/2015.",2020,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"['59 eligible patients, 36 (61']","['palliative long-term abdominal drains vs large-volume paracentesis', 'large-volume paracentesis vs long-term abdominal drains']","['Total attrition', 'peritonitis incidence', 'serum creatinine', 'Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital', 'Self-limiting cellulitis/leakage', 'median number (IQR) of hospital ascitic drains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441140', 'cui_str': 'Abdominal drain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040227', 'cui_str': 'Time Studies'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439685', 'cui_str': 'Ascitic'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}]",59.0,0.162379,Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively.,"[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macken', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Guildford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Crook', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mason', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Timeyin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Steer', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Austin', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parnell', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Thomson', 'Affiliation': 'Worthing, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sheridan', 'Affiliation': 'Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Isaacs', 'Affiliation': 'Blackpool, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hashim', 'Affiliation': 'Brighton, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15802'] 3129,32473640,"Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study.","BACKGROUND Omega-3 fatty acids (OM3-FAs) are recommended with a low-fat diet for severe hypertriglyceridemia (SHTG), to reduce triglycerides and acute pancreatitis (AP) risk. A low-fat diet may reduce pancreatic lipase secretion, which is required to absorb OM3-ethyl esters (OM3-EEs), but not OM3-carboxylic acids (OM3-CAs). METHODS In this exploratory, randomized, open-label, crossover study, 15 patients with SHTG and previous AP were instructed to take OM3-CA (2 g or 4 g) and OM3-EE 4 g once daily for 4 weeks, while adhering to a low-fat diet. On day 28 of each treatment phase, a single dose was administered in the clinic with a liquid low-fat meal, to assess 24-h plasma exposure. Geometric least-squares mean ratios were used for between-treatment comparisons of baseline (day 0)-adjusted area under the plasma concentration versus time curves (AUC 0-24 ) and maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). RESULTS Before initiating OM3-FA treatment, mean baseline fasting plasma EPA + DHA concentrations (nmol/mL) were 723 for OM3-CA 2 g, 465 for OM3-CA 4 g and 522 for OM3-EE 4 g. At week 4, mean pre-dose fasting plasma EPA + DHA concentrations increased by similar amounts (+ 735 - + 768 nmol/mL) for each treatment. During the 24-h exposure assessment (day 28), mean plasma EPA + DHA increased from pre-dose to the maximum achieved concentration by + 32.7%, + 45.8% and + 3.1% with single doses of OM3-CA 2 g, OM3-CA 4 g and OM3-EE 4 g, respectively. Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). CONCLUSIONS Greater 24-h exposure of OM3-CA versus OM3-EE was observed for some parameters when administered with a low-fat meal at the clinic on day 28. However, increases in pre-dose fasting plasma EPA + DHA over the preceding 4-week dosing period were similar between treatments, leading overall to non-significant differences in baseline (day 0)-adjusted AUC 0-24 and C max EPA + DHA values. It is not clear why the greater 24-h exposure of OM3-CA versus OM3-EE observed with a low-fat meal did not translate into significantly higher pre-dose fasting levels of DHA + EPA with longer-term use. TRIAL REGISTRATION ClinicalTrials.gov, NCT02189252, Registered 23 June 2014.",2020,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). ","['15 patients with SHTG and previous AP', 'patients with past hypertriglyceridemia-induced acute pancreatitis']","['Omega-3 fatty acid exposure with a low-fat diet', 'Omega-3 fatty acids (OM3-FAs', 'OM3-EE 4\u2009g once daily for 4\u2009weeks, while adhering to a low-fat diet', 'OM3-CA', 'OM3-CA versus OM3-EE']","['DHA concentrations', 'mean plasma EPA\u2009+\u2009DHA', 'maximum plasma concentrations (C max ) for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'pre-dose fasting plasma EPA\u2009+\u2009DHA', 'mean baseline fasting plasma EPA\u2009+\u2009DHA concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",15.0,0.0470296,"Baseline-adjusted AUC 0-24 was 60% higher for OM3-CA 4 g than for OM3-EE 4 g and baseline-adjusted C max was 94% higher (both non-significant). ","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Dunbar', 'Affiliation': 'Cardiometabolic and Lipid Clinic, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. r.l.dunbar@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Lipidology Unit, Community Genomic Medicine Centre and ECOGENE-21, Department of Medicine, Université de Montréal, Saguenay, QC, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rensfeldt', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Kvarnström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}]",Lipids in health and disease,['10.1186/s12944-020-01295-7'] 3130,32473644,Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial.,"BACKGROUND Coronary artery diseases (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure. Available neurohumoral treatment strategies aim at the improvement of symptoms. Despite extensive research, therapeutic options for myocardial regeneration, including (stem)-cell therapy, gene therapy, cellular reprogramming or tissue engineering, remain purely experimental. Thus, there is an urgent clinical need for novel treatment options for inducing myocardial regeneration and improving left-ventricular function in ischemic cardiomyopathy. Shockwave Therapy (SWT) is a well-established regenerative tool that is effective for the treatment of chronic tendonitis, long-bone non-union and wound-healing disorders. In preclinical trials, SWT regenerated ischemic myocardium via the induction of angiogenesis and the reduction of fibrotic scar tissue, resulting in improved left-ventricular function. METHODS/DESIGN In this prospective, randomized controlled, single-blind, monocentric study, 80 patients with reduced left-ventricular ejection fraction (LVEF≤ 40%) are subjected to coronary-artery bypass-graft surgery (CABG) surgery and randomized in a 1:1 ratio to receive additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment (control group; 40 patients). This study aims to evaluate (1) the safety and (2) the efficacy of cardiac SWT as adjunctive treatment during CABG surgery for the regeneration of ischemic myocardium. The primary endpoints of the study represent (1) major cardiac events and (2) changes in left-ventricular function 12 months after treatment. Secondary endpoints include 6-min Walk Test distance, improvement of symptoms and assessment of quality of life. DISCUSSION This study aims to investigate the safety and efficacy of cardiac SWT during CABG surgery for myocardial regeneration. The induction of angiogenesis, decrease of fibrotic scar tissue formation and, thus, improvement of left-ventricular function could lead to improved quality of life and prognosis for patients with ischemic heart failure. Thus, it could become the first clinically available treatment strategy for the regeneration of ischemic myocardium alleviating the socio-economic burden of heart failure. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03859466. Registered on 1 March 2019.",2020,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"['80 patients with reduced left-ventricular ejection fraction (LVEF≤\u200940', 'patients with ischemic heart failure', 'patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial']","['Shockwave Therapy (SWT', 'coronary-artery bypass-graft surgery (CABG) surgery', 'cardiac SWT', 'direct Cardiac Shockwave Therapy', 'additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment']","['fibrotic scar tissue formation', 'study represent (1) major cardiac events and (2) changes in left-ventricular function', '6-min Walk Test distance, improvement of symptoms and assessment of quality of life', 'quality of life and prognosis', 'Safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0241158', 'cui_str': 'Scar of skin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.112858,Post-infarctional remodeling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure.,"[{'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pölzl', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Nägele', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Graber', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hirsch', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Lobenwein', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mitrovic', 'Affiliation': 'Clinical Trial Center, Medical University of Innsbruck, Innrain 52, 6020, Innsbruck, Austria.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Theurl', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schreinlechner', 'Affiliation': 'University Clinic of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Pamminger', 'Affiliation': 'University Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorfmüller', 'Affiliation': 'Heart Regeneration Technologies GmbH, Innsbruck, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grimm', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Gollmann-Tepeköylü', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Holfeld', 'Affiliation': 'University Clinic of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Johannes.holfeld@i-med.ac.at.'}]",Trials,['10.1186/s13063-020-04369-0'] 3131,32475183,Does lopinavir measure up in the treatment of COVID-19?,"INTRODUCTION Lopinavir in combination with ritonavir is approved for the treatment of HIV and has recently been subject to a clinical trial in severe COVID-19. AREAS COVERED This evaluation is of LOTUS China (the Lopinavir Trial for Suppression of SARS-Cov-2 in China), which was a randomized trial in hospitalized subjects with COVID-9 in a respiratory sample and pneumonia. As, in severe COVID-19, lopinavir/ritonavir had no beneficial effects but increased gastrointestinal adverse effects, this combination should not be used at this stage of COVID-19. EXPERT OPINION In my opinion, the rationale for undertaking a trial of lopinavir/ritonavir in COVID-19 was poor. The analysis of a modified intention to treat group analysis in LOTUS China may have introduced bias. After LOTUS China, there is probably no future for lopinavir in the treatment of severe COVID-19, but some clinical trials for prevention or in various stages of COVID-19 have recently started or are ongoing. The major limitation of these trials is that as lopinavir does not inhibit COVID-19, it is unlikely to prevent infection, reduce viral load, or reduce the severity. However, these trials may be worthwhile in finally determining whether lopinavir has any role in preventing or treating COVID-19.",2020,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.",['hospitalised subjects with Covid-9 in a respiratory sample and pneumonia'],"['lopinavir', 'ritonavir', 'lopinavir/ritonavir']",['gastrointestinal adverse effects'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444279', 'cui_str': 'Respiratory sample'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.148574,"After LOTUS China, there is probably no future for lopinavir in the treatment of severe Covid-19, but some clinical trials for prevention or in various stages of Covid-19 have recently started or are ongoing.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1777277'] 3132,32475312,"Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids in Untreated Hypertensives: A Randomized, Double-Blind, Placebo-Controlled Trial.","High-sodium diet may modulate the gut microbiome. Given the circulating short-chain fatty acids (SCFAs) are microbial in origin, we tested the hypothesis that the modest sodium reduction would alter circulating SCFA concentrations among untreated hypertensives, and the changes would be associated with reduced blood pressure and improved cardiovascular phenotypes. A total of 145 participants (42% blacks, 19% Asian, and 34% females) were included from a randomized, double-blind, placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets, each for 6 weeks. Targeted circulating SCFA profiling was performed in paired serum samples, which were collected at the end of each period, so as all outcome measures. Sodium reduction increased all 8 SCFAs, among which the increases in 2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate were statistically significant ( P s<0.05). Also, increased SCFAs were associated with decreased blood pressure and improved arterial compliance. There were significant sex differences of SCFAs in response to sodium reduction ( P s<0.05). When stratified by sex, the increases in butyrate, hexanoate, isobutyrate, isovalerate, and valerate were significant in females only ( P s<0.05), not in males ( P s>0.05). In females, changes in isobutyrate, isovalerate, and 2-methylbutyrate were inversely associated with reduced blood pressures ( P s<0.05). Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040). Our results show that dietary sodium reduction increases circulating SCFAs, supporting that dietary sodium may influence the gut microbiome in humans. There is a sex difference in SCFA response to sodium reduction. Moreover, increased SCFAs are associated with decreased blood pressures and improved arterial compliance. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00152074.",2020,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"['145 participants (42% blacks, 19% Asian, and 34% females', 'Untreated Hypertensives']","['placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets', 'Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids', 'Placebo', 'High-sodium diet']","['blood pressures and improved arterial compliance', 'Sodium reduction', 'SCFA response', 'blood pressures', '2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate', 'circulating SCFA concentrations', 'blood pressure and improved cardiovascular phenotypes', 'carotid-femoral pulse wave velocity', 'blood pressure and improved arterial compliance', 'butyrate, hexanoate, isobutyrate, isovalerate, and valerate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0046367', 'cui_str': '2-methylbutyrate'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0121652', 'cui_str': 'hexanoate'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",145.0,0.135264,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Changqiong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Harshfield', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14800'] 3133,32475989,A randomized placebo-controlled PET study of ketamine´s effect on serotonin 1B receptor binding in patients with SSRI-resistant depression.,"The glutamate N-methyl-D-aspartate receptor antagonist ketamine has a rapid antidepressant effect. Despite large research efforts, ketamine's mechanism of action in major depressive disorder (MDD) has still not been determined. In rodents, the antidepressant properties of ketamine were found to be dependent on both the α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) and the serotonin (5-HT) 1B receptor. Low 5-HT 1B receptor binding in limbic brain regions is a replicated finding in MDD. In non-human primates, AMPA-dependent increase in 5-HT 1B receptor binding in the ventral striatum (VST) has been demonstrated after ketamine infusion. Thirty selective serotonin reuptake inhibitor-resistant MDD patients were recruited via advertisement and randomized to double-blind monotherapy with 0.5 mg/kg ketamine or placebo infusion. The patients were examined with the 5-HT 1B receptor selective radioligand [ 11 C]AZ10419369 and positron emission tomography (PET) before and 24-72 h after treatment. 5-HT 1B receptor binding did not significantly alter in patients treated with ketamine compared with placebo. An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment. 5-HT 1B receptor binding in VST at baseline correlated with MDD symptom ratings (r = -0.426, p = 0.019) and with reduction of depressive symptoms with ketamine (r = -0.644, p = 0.002). In conclusion, reduction of depressive symptoms in MDD patients after ketamine treatment is correlated inversely with baseline 5-HT 1B receptor binding in VST. Further studies examining the role of 5-HT 1B receptors in the antidepressant mechanism of action of ketamine should be conducted, homing in on the 5-HT 1B receptor as an MDD treatment response marker.",2020,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"['Thirty selective serotonin reuptake inhibitor-resistant MDD patients', 'patients with SSRI-resistant depression']","['glutamate N-methyl-D-aspartate receptor antagonist ketamine', 'ketamine', 'ketamine or placebo infusion', 'placebo']","['MDD symptom ratings', 'depressive symptoms', '5-HT 1B receptor binding']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C0535025', 'cui_str': '5-HT1B Receptor'}]",30.0,0.0756628,An increase in 5-HT 1B receptor binding with 16.7 % (p = 0.036) was found in the hippocampus after one ketamine treatment.,"[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Tiger', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden. mikael.tiger@ki.se.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Veldman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Ekman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Halldin', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lundberg', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-0844-4'] 3134,32483147,"Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.","Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.",2020,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.",['healthy full term infants according to the type of delivery (n\u2009=\u200913/group'],"['Lactobacillus paracasei CBA', 'dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula']","['secretory IgA', 'safe and well tolerated']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}]",,0.03072,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Roggero', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Liotto', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pozzi', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Braga', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Troisi', 'Affiliation': 'Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Menis', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria Lorella', 'Initials': 'ML', 'LastName': 'Giannì', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Budelli', 'Affiliation': 'School of Engineering, Niccoló Cusano University, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu.'}]",Nature communications,['10.1038/s41467-020-16582-1'] 3135,32479544,Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.,"Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.",2020,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"['155 women with PCOS and a BMI above 25 kg/m2 were eligible', 'women with Polycystic Ovary Syndrome (PCOS', 'women with PCOS', 'women with PCOS who are overweight or obese and attempting to become pregnant']","['three-component lifestyle intervention', 'CBT', '3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT', '20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight']","['Depression scores', 'depression and self-esteem', 'Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol', 'depression scores', 'body image scores', 'self-esteem', 'Self-esteem scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",155.0,0.0638994,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233876'] 3136,32480252,The Efficacy of Lidocaine in Disrupting Cocaine Cue-Induced Memory Reconsolidation.,"RATIONAL Cue-induced craving memories, linked to drug-seeking behaviors, require key molecular processes for memory reconsolidation. Lidocaine, a sodium channel blocker, inhibits NMDA receptor activation and suppresses nitric oxide and ERK production. These processes are required for memory re-consolidation; inhibiting them may reduce cue-related craving memories in cocaine dependent subjects. OBJECTIVES To assess the efficacy of lidocaine in decreasing cue-induced cocaine craving and cocaine use. METHODS Treatment-seeking cocaine-dependent participants (n = 33, 25 men) were recruited. Personalized craving and relaxation scripts were developed. Participants were then randomly assigned in a double-blind design to either receive intravenous lidocaine immediately following a cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax). One week following the infusion, cue-induced craving was assessed in the same paradigm without an infusion. Cocaine use and craving were assessed for 4 weeks following infusion. RESULTS The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group. There were no significant differences in craving and cocaine use between the lidocaine/relax and saline/craving groups. CONCLUSION Lidocaine administered following craving induction did not decrease subsequent cue-induced craving or cocaine use. Blocking the reconsolidation of craving-related memories with pharmacological agents remains an important area of investigation.",2020,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"['Treatment-seeking cocaine-dependent participants (n = 33, 25 men']","['Lidocaine', 'lidocaine/craving', 'lidocaine', 'intravenous lidocaine', 'cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax', 'Cocaine']",['craving and cocaine'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",,0.054462,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"[{'ForeName': 'Josh E', 'Initials': 'JE', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leonard', 'Affiliation': 'David Leonard Statistical Consulting, Wichita Falls, TX USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Suris', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Kandil', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA; Department of Anesthesiology & Pain Management, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kroener', 'Affiliation': 'School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108062'] 3137,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression. METHOD A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression. RESULTS A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001). CONCLUSION These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145'] 3138,32491124,Effects of dry and traditional bed bathing on respiratory parameters: a randomized pilot study.,"OBJECTIVE to compare the time for performance of dry and traditional bed bathing and its effects on transcutaneous arterial oxygen saturation and respiratory rates in critical adult patients. METHOD pilot study of a randomized, open, crossover clinical trial, performed with 15 adult critically ill patients. Each patient received a dry and a traditional bed bath. Analysis of variance with repeated measures was used, adopting p-value ≤ 0.05. RESULTS most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years. The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001). There was no significant difference between the patients' saturation means between baths (p=0.381), with 94.7% for the dry bath and 95.2% for the traditional bath. During the traditional bath, the patients' respiratory rate mean was higher (24.2 incursions per minute) and statistically different (p<0.001) from the value obtained for the dry bath (20.5 incursions per minute). CONCLUSION the dry bath had a shorter duration than did the traditional bath, resulting in less patient exposure. The traditional bed bath had a negative effect on patients' respiratory rate, increasing it. Brazilian Registry of Clinical Trials (ReBEC): RBR-5qwkqd.",2020,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"['Brazilian Registry of Clinical Trials (ReBEC', 'most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years', 'critical adult patients', '15 adult critically ill patients']",['dry and traditional bed bathing'],"['transcutaneous arterial oxygen saturation and respiratory rates', 'respiratory parameters', 'respiratory rate mean']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",15.0,0.0337215,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"[{'ForeName': 'Luana Vieira', 'Initials': 'LV', 'LastName': 'Toledo', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Patrícia de Oliveira', 'Initials': 'PO', 'LastName': 'Salgado', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Cristiane Chaves de', 'Initials': 'CC', 'LastName': 'Souza', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Lídia Miranda', 'Initials': 'LM', 'LastName': 'Brinati', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital São Sebastião, Viçosa, MG, Brasil.'}, {'ForeName': 'Carla de Fátima', 'Initials': 'CF', 'LastName': 'Januário', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Flávia Falci', 'Initials': 'FF', 'LastName': 'Ercole', 'Affiliation': 'Escola de Enfermagem, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3668.3264'] 3139,32487038,A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS).,"BACKGROUND Metastasis directed therapy (MDT) for patients with oligometastatic disease is associated with improvements in progression free survival (PFS) and overall survival (OS) compared to systemic therapy alone. Additionally, within a prostate-cancer-specific cohort, MDT is able to forestall initiation of androgen deprivation therapy (ADT) in men with hormone-sensitive, oligometastatic prostate cancer (HSOPCa) compared to observation. While MDT appears to be safe and effective in HSOPCa, a large percentage of men will eventually have disease recurrence. Patterns of failure in HSOPCa demonstrate patients tend to have recurrence in the bone following MDT, raising the question of sub-clinically-apparent osseous disease. Radium-223 dichloride is a radiopharmaceutical with structural similarity to calcium, allowing it to be taken up by bone where it emits alpha particles, and therefore might have utility in the treatment of micrometastatic osseous disease. Therefore, the primary goal of the phase II RAVENS trial is to evaluate the efficacy of MDT + radium-223 dichloride in prolonging progression free survival in men with HSOPCa. METHODS Patients with HSOPCa and 3 or less metastases with at least 1 bone metastasis will be randomized 1:1 to stereotactic ablative radiation (SABR, also known as stereotactic body radiation therapy (SBRT)) alone vs SABR + radium-223 dichloride with a minimization algorithm to balance assignment by institution, primary intervention, prior hormonal therapy, and PSA doubling time. SABR is delivered in one to five fractions and patients in the SABR + radium-223 dichloride arm will receive six infusions of radium-223 dichloride at four-week intervals. The primary end point is progression free survival. The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response. DISCUSSION The RAVENS trial will be the first described phase II, non-blinded, randomized study to compare SABR +/- radium-223 dichloride in patients with HSOPCa and 3 or less metastases with at least one bone metastasis. The primary hypothesis is that SABR + radium-223 dichloride will increase median progression-free survival from 10 months in the SABR arm to 20 months in the SABR + radium-223 dichloride arm. TRIAL REGISTRATIONS Clinicaltrials.gov. Identifier: NCT04037358. Date of Registration: July 30, 2019. Date of First Participant Enrolled: August 9, 2019. Date of Last Approved Amendment: October 16, 2019. Protocol Version: Version 5.",2020,"The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response. ","['men with HSOPCa', 'patients with oligometastatic disease', 'Patients with HSOPCa and 3 or less metastases with at least 1 bone metastasis', 'patients with HSOPCa and 3 or less metastases with at least one bone metastasis', 'men with hormone-sensitive, oligometastatic prostate cancer (HSOPCa']","['stereotactic ablative radiation (SABR, also known as stereotactic body radiation therapy (SBRT)) alone vs SABR + radium-223 dichloride with a minimization algorithm to balance assignment by institution, primary intervention, prior hormonal therapy, and PSA doubling time', 'RAdium-223 dichloride and SABR Versus SABR', 'Metastasis directed therapy (MDT', 'androgen deprivation therapy (ADT']","['progression free survival', 'toxicity and quality of life assessments, local control at 12\u2009months, locoregional progression, time to distant progression, time to new metastasis, and duration of response', 'progression free survival (PFS) and overall survival (OS', 'median progression-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3541342', 'cui_str': 'RADIUM CHLORIDE RA-223'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0554777,"The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response. ","[{'ForeName': 'Hamza', 'Initials': 'H', 'LastName': 'Hasan', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Deek', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hobbs', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Malek', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Radwan', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Kiess', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Shirl', 'Initials': 'S', 'LastName': 'Dipasquale', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Caldwell', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leitzel', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Wendler', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Dudley', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Curtiland', 'Initials': 'C', 'LastName': 'Deville', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Greco', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'DeWeese', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Denmeade', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Markowski', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Channing J', 'Initials': 'CJ', 'LastName': 'Paller', 'Affiliation': 'Department of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 1550 Orleans Street, CRB2 Rm 406, Baltimore, MD, 21231, USA. tranp@jhmi.edu.'}]",BMC cancer,['10.1186/s12885-020-07000-2'] 3140,32487065,Effects of an mHealth voice message service (mMitra) on maternal health knowledge and practices of low-income women in India: findings from a pseudo-randomized controlled trial.,"BACKGROUND Mobile Health (mHealth) is becoming an important tool to improve health outcomes in maternal, newborn and child health (MNCH). Studies of mHealth interventions, have demonstrated their effectiveness in improving uptake of recommended maternal services such as antenatal visits. However, evidence of impact on maternal health outcomes is still limited. METHODS A pseudo-randomized controlled trial (single blind) was conducted to assess the impact of a voice-message based maternal intervention on maternal health knowledge, attitudes, practices and outcomes over time: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned one year old (Time 3). Women assigned to the mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi, while those assigned to the control group did not. Both groups received standard care. RESULTS Two thousand sixteen women were enrolled. Interviews were conducted with 1516 women in the intervention group and 500 women in the control group at baseline and post-partum. The intervention group performed significantly better than controls on four maternal health practice indicators: receiving the tetanus toxoid injection (OR: 1.6, 95% Confidence Interval (CI): 1.05-2.4, p = 0.028), consulting a doctor if spotting or bleeding (OR: 1.72, 95%CI: 1.07-2.75, p = 0.025), saving money for delivery expenses (OR: 1.79, 95%CI: 1.38-2.33, p = 0.0001), and delivering in hospital (OR: 2.5, 95%CI: 1.49-4.35, p = 0.001). The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027). Both groups' knowledge improved from Time 1 to Time 2. Only one knowledge indicator, on seeking medical care during pregnancy, was statistically increased in the intervention group compared to controls. Anemia status at or near the time of delivery was unable to be assessed due to missing data from maternal health cards. CONCLUSIONS This study provides evidence that in low-resource settings, mobile voice messages providing tailored and timed information about pregnancy can positively impact maternal health care practices proven to improve maternal health outcomes. Additional research is needed to assess whether voice messaging can motivate behavior change better than text messaging, particularly in low literacy settings. TRIAL REGISTRATION The mMitra impact evaluation is registered with ISRCTN under Registration # 88968111, assigned on 6 September 2018 (See https://www.isrctn.com/ISRCTN88968111).",2020,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","['low-income women in India', '1516 women in the intervention group and 500 women in the control group at baseline and post-partum', 'Two thousand sixteen women were enrolled']","['mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi', 'standard care', 'mHealth voice message service (mMitra', 'tetanus toxoid injection', 'voice-message based maternal intervention']","['consulting a doctor if spotting or bleeding', 'maternal health knowledge and practices', 'maternal health knowledge, attitudes, practices and outcomes over time', 'maternal health outcomes', 'saving money for delivery expenses', 'Anemia status']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0019547', 'cui_str': 'Hindi language'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",2016.0,0.207524,"The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54-0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23-0.91, p = 0.027).","[{'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Murthy', 'Affiliation': 'Foundation for Research in Health Systems, #G-1, Brigade Business Suites, 10th Main, Jayanagar 2nd Block, Bengaluru, 560011, India.'}, {'ForeName': 'Subhashini', 'Initials': 'S', 'LastName': 'Chandrasekharan', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Muthu Perumal', 'Initials': 'MP', 'LastName': 'Prakash', 'Affiliation': 'Foundation for Research in Health Systems, G2, 5/26 Pillayar Kovil Street, Medavakkam, Chennai, 600100, India.'}, {'ForeName': 'Aakash', 'Initials': 'A', 'LastName': 'Ganju', 'Affiliation': 'Saat Health, 1103, Glencroft, Hiranandani Gardens, Powai, Mumbai, 400076, India.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Peter', 'Affiliation': 'Johnson & Johnson, 241 Main Road, Retreat, Cape Town, 7945, South Africa.'}, {'ForeName': 'Nadi', 'Initials': 'N', 'LastName': 'Kaonga', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Mechael', 'Affiliation': 'HealthEnabled, Unit D11 Westlake Square, Westlake Drive, Westlake, Cape Town, 7945, South Africa. pmechael@gmail.com.'}]",BMC public health,['10.1186/s12889-020-08965-2'] 3141,32487077,Anodal transcranial direct current stimulation reduces motor slowing in athletes and non-athletes.,"BACKGROUND Motor fatigability describes a phenomenon that occurs when exhaustive exercise or physically demanding tasks are executed over an extended period of time. Concerning fast repetitive movements, it is noticeable by a reduction in movement speed (motor slowing, MoSlo) and occurs due to both central and peripheral factors. The aim of the present study was to examine the presence of MoSlo during hand- (HTT) and foot-tapping tasks (FTT) comparing trained football (FB) and handball players (HB) and non-athletes (NA). Furthermore, we were interested in how far anodal transcranial direct current stimulation (tDCS) might be capable of modulating MoSlo as compared to sham. METHODS A total number of 46 participants were enrolled in a sham-controlled, double-blinded, cross-over study. HTT and FTT were performed before, during, after as well as 30 min after 20 min of tDCS over the leg area of the primary motor cortex (M1). RESULTS We could demonstrate that MoSlo during HTT and FTT is a general phenomenon that is observed independent of the type of sports and/or training status. Furthermore, we were able to show a tDCS-induced reduction in MoSlo specifically during FTT in both trained athletes and NA. No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level. CONCLUSION We could demonstrate that tDCS is capable of reducing motor fatigability during fast repetitive movements. These findings are of pivotal interest for many sports where fatigability resistance is a limiting factor in maintaining repetitive movement patterns.",2020,"No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level. ","['A total number of 46 participants', 'athletes and non-athletes']","['MoSlo during hand- (HTT) and foot-tapping tasks (FTT) comparing trained football (FB) and handball players (HB) and non-athletes (NA', 'anodal transcranial direct current stimulation (tDCS', 'tDCS', 'Anodal transcranial direct current stimulation']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],46.0,0.0622472,"No such effects could be observed for HTT, indicating local specificity of tDCS-induced effects on a behavioral level. ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Seidel-Marzi', 'Affiliation': 'Institute for General Kinesiology and Exercise Science, Faculty of Sport Science, University of Leipzig, Jahnallee 59, 04109, Leipzig, Germany. oliver.seidel@uni-leipzig.de.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ragert', 'Affiliation': 'Institute for General Kinesiology and Exercise Science, Faculty of Sport Science, University of Leipzig, Jahnallee 59, 04109, Leipzig, Germany.'}]",BMC neuroscience,['10.1186/s12868-020-00573-5'] 3142,32487120,The long and winding road to happiness: A randomized controlled trial and cost-effectiveness analysis of a positive psychology intervention for lonely people with health problems and a low socio-economic status.,"BACKGROUND Our objective was to evaluate the effectiveness and cost-effectiveness of the positive psychology intervention 'Happiness Route' compared to an active control condition in a vulnerable population with an accumulation of health and psychosocial problems. METHODS We conducted a randomized, single-blind, actively-controlled, parallel group study in seven municipalities in the Netherlands. To be eligible, participants had to experience loneliness, health problems and low socio-economic status. Each group received several home visits by a counsellor (two in the control condition, two to six in the experimental condition). In the Happiness Route, a happiness-based approach was used, whereas the control condition used a traditional problem-based approach. The primary outcome was well-being, measured with the Mental Health Continuum-Short Form (MHC-SF). RESULTS Fifty-eight participants were randomized to the Happiness Route, 50 to the control condition. Participants were severely lonely, had on average three health problems and less than 5% had paid work. The total MHC-SF score, emotional and social well-being, depression and loneliness improved significantly over the nine-month period in both conditions (p < .05), but there were no significant changes between the conditions across time. Languishing decreased significantly from 33% at baseline to 16% at follow-up among the Happiness Route participants but did not change significantly in the control condition. No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation. Cost-effectiveness analysis showed that expected saved costs per QALY lost was €219,948 for the Happiness Route, relative to the control condition. The probability was 83% that the Happiness Route was cost saving and 54% that the Happiness Route was cost-effective at a willingness to accept a threshold of €100,000. CONCLUSIONS Mental health status of both groups improved considerably. However, we could not demonstrate that the Happiness Route yielded better health outcomes compared to the control condition. Nevertheless, the results of the cost-effectiveness analysis suggested that the Happiness Route is an acceptable intervention from a health-economic point of view. Our results should be viewed in light of the fact that we could not include the planned number of participants. TRIAL REGISTRATION Netherlands Trial Register: NTR3377. Registered 2 Apr 2012.",2020,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","['Fifty-eight participants', 'participants had to experience loneliness, health problems and low socio-economic status', 'lonely people with health problems and a low socio-economic status', 'Participants were severely lonely, had on average three health problems and less than 5% had paid work', 'seven municipalities in the Netherlands']","['NTR3377', 'positive psychology intervention', ""positive psychology intervention 'Happiness Route""]","['total MHC-SF score, emotional and social well-being, depression and loneliness', 'psychological well-being, resilience, purpose in life, health-related quality of life and social participation', 'effectiveness and cost-effectiveness', 'well-being, measured with the Mental Health Continuum-Short Form (MHC-SF', 'health outcomes']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.0683567,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Weiss', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands. weiss.laura.a@gmail.com.'}, {'ForeName': 'Martijn A H', 'Initials': 'MAH', 'LastName': 'Oude Voshaar', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Gerben J', 'Initials': 'GJ', 'LastName': 'Westerhof', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01416-x'] 3143,32487131,"Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study.","BACKGROUND Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases. However, typically a wide range of interindividual variability exists in response across individuals to nutritional and natural health product bioactives, such as plant sterols (PS). This study aims to determine and utilize information on the associations between genosets and the degree of responsiveness to dietary PS intervention, with a long-term objective of developing genetic tests to predict responses to PS. METHODS This clinical trial is designed as a double-blind, placebo controlled, randomized two-period crossover study. Sixty-four eligible participants with the specific a priori-determined single nucleotide polymorphisms (SNPs) associated with a responsiveness to PS will consume PS or a placebo treatment for two 4-week periods. The PS treatment consists of two daily single portions of margarine, each providing 1 g PS during the PS period (2.0 g/day of PS in total). The placebo will be an identical margarine containing no added PS. Low-density lipoprotein cholesterol (LDL-C) responsiveness to the controlled administration of PS will be investigated as the primary outcome, and the associations between interindividual genoset variabilities and response to PS consumption will be determined. DISCUSSION This research will provide further insight into whether the associations between previously identified SNPs and the response of LDL-C to PS consumption can be used in a predictive manner. It will also provide insight into the complexities of undertaking a nutrigenetic trial with prospective recruitment based on genotype. TRIAL REGISTRATION ClinicalTrials.gov: Identifier: NCT02765516. Registered on 6 May 2016.",2020,"BACKGROUND Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases.",['Sixty-four eligible participants with the specific a priori-determined single nucleotide polymorphisms (SNPs) associated with a responsiveness to PS will consume PS or a'],"['dietary PS intervention', 'PS', 'dietary plant sterol intervention (GenePredict-PS', 'placebo']",[],"[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],64.0,0.512484,"BACKGROUND Functional food ingredients and natural health products have been demonstrated to reduce disease risk and thereby help to lower health care costs across populations at risk for chronic or degenerative diseases.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Granger', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Elke A', 'Initials': 'EA', 'LastName': 'Trautwein', 'Affiliation': 'Unilever R & D Vlaardingen, Vlaardingen, The Netherlands.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'House', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'MacKay', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agriculture and Food Sciences, University of Manitoba, Winnipeg, MB, Canada. dylan.mackay@umanitoba.ca.'}]",Trials,['10.1186/s13063-020-04364-5'] 3144,32485325,A pharmacy liaison-patient navigation intervention to reduce inpatient and emergency department utilization among primary care patients in a Medicaid accountable care organization: A pragmatic trial protocol.,"OBJECTIVE To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital. BACKGROUND Prior studies have demonstrated only modest effects in reducing utilization among safety-net patient populations. Interventions that address health-related social needs have the potential to reduce utilization in these populations. DESIGN/METHODS Assignment to treatment condition is by medical record number (odd vs. even) and is unblinded (NCT03919084). Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled. DISCUSSION Our study will advance the field in two ways: 1) by providing evidence about the effectiveness of pharmacy liaisons who also function as patient navigators; and 2) by de-implementing patient navigators. Patients in the enhanced usual care arm will no longer receive the services of a clinic-based patient navigator. In addition, our study includes a novel collaboration with a community-based organization, and focuses on an intermediate-cost patient population, rather than the most costly patient population.",2020,"OBJECTIVE To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital. ","['connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital', 'Adults age 18-64 within the 3rd to 10th percentile for health care utilization and cost among Medicaid Accountable Care Organization membership attending a primary care visit in the general internal medicine practice at Boston Medical Center enrolled', 'primary care patients in a Medicaid accountable care organization']",['pharmacy liaison-patient navigation intervention'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3179030', 'cui_str': 'Accountable Care Organization'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0200654,"OBJECTIVE To determine whether employing the services of a pharmacy liaison to promote medication adherence (usual care), relative to a pharmacy liaison with training in motivational interviewing and as a patient navigator who systematically screens for health-related social needs and provides targeted navigation services to connect patients with appropriate community resources in partnership with a community-based organization (enhanced usual care), will reduce inpatient hospital admissions and emergency department visits among patients who are members of a Medicaid ACO and receive primary care at a large urban safety-net hospital. ","[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Karen.Lasser@bmc.org.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Buitron de la Vega', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, 801 Massachusetts Ave, 6th Floor, Boston, MA 02119, USA; Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Pablo.BuitrondelaVega@bmc.org.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Ashe', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Erin.Ashe@bmc.org.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA 02118, USA. Electronic address: zxuan@bu.edu.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Alva', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Sonia.Alva@bmc.org.'}, {'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Battisti', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Leandra.Battisti@bmc.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Losi', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Stephanie.Losi@bmc.org.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Christina.Sieber@bostonabcd.org.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Richards', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Carla.Richards@bostonabcd.org.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Patricia.Sullivan@bostonabcd.org.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Triscari', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Leah.Triscari@bostonabcd.org.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brody', 'Affiliation': 'Action for Boston Community Development Inc., 178 Tremont St, Boston, MA 02111, USA. Electronic address: Lauren.Brody@bostonabcd.org.'}, {'ForeName': 'Mary-Tara', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Clinical Research Resources Office, Boston Medical Center, Boston University Medical Campus, 75 E Newton St, Evans Building, 7(th) Floor, Boston, MA 02118, USA. Electronic address: Mary-Tara.Roth@bmc.org.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA 02118, USA. Electronic address: Alison.LeBlanc@bmc.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Boston University School of Medicine, 72 E Concord St, Boston, MA 02118, USA; Section of General Academic Pediatrics, Boston Medical Center, 72 East Concord St, Vose Building, 3(rd) Floor, Boston, MA 02118, USA. Electronic address: Michael.Silverstein@bmc.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106046'] 3145,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking. RESEARCH QUESTION Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters. METHODS This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments. RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain. SIGNIFICANCE This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030'] 3146,32445440,Remdesivir for the Treatment of Covid-19 - Preliminary Report.,"BACKGROUND Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. METHODS We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). CONCLUSIONS Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764'] 3147,32475838,"Long-term changes in carbohydrate tolerance, insulin secretion and action in African-American patients with obesity and history of hyperglycemic crises.","INTRODUCTION Many African-Americans (AA) with obesity with newly diagnosed diabetes presenting with diabetic ketoacidosis (DKA) or severe hyperglycemia (SH) discontinue insulin therapy and achieve near-normoglycemia remission (hemoglobin A1c (HbA1c) <7%, fasting blood glucose (FBG) <130 mg/dL) and able to be managed on oral antidiabetic agents (OAD) during follow-up. Using combined data from two randomized controlled trials, we assessed long-term carbohydrate tolerance and changes in insulin sensitivity and insulin secretion. RESEARCH DESIGN AND METHODS Seventy-five participants with DKA (n=33) and SH (n=42) underwent 2-hour 75 g oral glucose tolerance test (OGTT) after insulin discontinuation and every 6 months until hyperglycemia relapse (FBG ≥130 mg/dL, HbA1c >7% or two random BG ≥180 mg/dL) while treated with OAD (metformin, sitagliptin or pioglitazone) or placebo. Glucose tolerance status was defined as per the American Diabetes Association. Sensitivity index (S i ) was calculated by oral minimal model, insulin secretion as the incremental area under the curve of insulin (IncreAUC i ) and disposition index (DI) as S i ×IncreAUC i . RESULTS During remission, OGTT showed normal glucose tolerance (NGT) (n=9 (12%)), prediabetes (n=34 (45%)) and diabetes (n=32 (43%)). DI and S i were higher in patients with NGT versus prediabetes versus diabetes (p<0.001), while IncreAUC i was not significantly different among NGT, prediabetes and diabetes (p=0.14). Achieving NGT status did not prolong near-normoglycemia remission. OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04). CONCLUSIONS In AA patients with obesity with history of DKA and SH, near-normoglycemia remission is associated with improved insulin secretion and action with half of patients achieving NGT or prediabetes, and only half having diabetes on OGTT. NGT and prediabetes on OGTT were not associated with prolonged hyperglycemia relapse-free survival. TRIAL REGISTRATION NUMBER NCT01099618, NCT00426413.",2020,"OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04). ","['African-Americans (AA) with obesity with newly diagnosed diabetes presenting with diabetic ketoacidosis (DKA) or severe hyperglycemia (SH) discontinue insulin therapy and achieve near-normoglycemia remission (hemoglobin A1c (HbA1c', 'African-American patients with obesity and history of hyperglycemic crises', 'Seventy-five participants with DKA (n=33) and SH (n=42) underwent', 'In AA patients with obesity with history of DKA and SH, near-normoglycemia remission']","['OAD (metformin, sitagliptin or pioglitazone) or placebo', '2-hour 75\u2009g oral glucose tolerance test (OGTT) after insulin discontinuation and every 6 months until hyperglycemia relapse (FBG ≥130\u2009mg/dL', 'placebo']","['incremental area under the curve of insulin (IncreAUC i ) and disposition index (DI', 'Glucose tolerance status', 'near-normoglycemia remission', 'Sensitivity index (S i ', 'DI and S i', 'prolonged hyperglycemia relapse-free survival', 'carbohydrate tolerance, insulin secretion and action', 'hyperglycemia relapse-free survival', 'fasting blood glucose (FBG', 'insulin sensitivity and insulin secretion', 'hyperglycemia relapse', 'normal glucose tolerance (NGT']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}]",75.0,0.0347916,"OAD treatment significantly prolonged hyperglycemia relapse-free survival (log-rank p=0.0012) compared with placebo and was associated with lower hyperglycemia relapse (HR: 0.45, 95% CI: (0.21 to 0.96), p=0.04). ","[{'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA priyathama.vellanki@emory.edu.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Stefanovski', 'Affiliation': 'Department of Clinical Studies-New Bolton Center, University of Pennsylvania School of Veterinary Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Isabel I', 'Initials': 'II', 'LastName': 'Anzola', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Dawn D', 'Initials': 'DD', 'LastName': 'Smiley', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-001062'] 3148,32475846,Periodontal ligament proliferation and expressions of bone biomolecules upon orthodontic preloading: Clinical implications for tooth autotransplantation.,"Objective Preservation of the periodontal ligament (PDL) is vital to the success of tooth autotransplantation (TAT). Increased PDL volumes and facilitated tooth extraction have been observed upon orthodontic preloading. However, it is unclear whether any changes occur in the expressions of bone biomolecules in the increased PDL volumes. This study aimed to determine the expressions of runt-related transcription factor 2 (RUNX2), alkaline phosphatase (ALP), receptor activator of nuclear factor kappa-B ligand (RANKL), and osteoprotegerin (OPG) in PDL upon preloading. Methods Seventy-two premolars from 18 patients were randomly assigned to experimental groups that received a leveling force for 1, 2, or 4 weeks or to a control unloaded group. Following extraction, PDL volumes from 32 premolars of eight patients (21.0 ± 3.8 years) were evaluated using toluidine blue staining. The expressions of the biomolecules in the PDL from 40 premolars of ten patients (21.4 ± 4.0 years) were analyzed via immunoblotting. Results The median percentage of stained PDL was significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05). The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05). Conclusions Orthodontic preloading for 4 weeks enhances PDL volumes as well as the expressions of RUNX2, ALP and the RANKL/OPG ratio in the PDL, suggesting this loading period is suitable for successful TAT.",2020,"The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05). ","['tooth autotransplantation', '40 premolars of ten patients (21.4 ± 4.0 years) were analyzed via immunoblotting', 'Methods\n\n\nSeventy-two premolars from 18 patients', '32 premolars of eight patients (21.0 ± 3.8 years) were evaluated using toluidine blue staining']",['periodontal ligament (PDL'],"['median RUNX2 and ALP expression levels', 'Increased PDL volumes', 'expressions of runt-related transcription factor 2 (RUNX2), alkaline phosphatase (ALP), receptor activator of nuclear factor kappa-B ligand (RANKL), and osteoprotegerin (OPG', 'median percentage of stained PDL', 'median RANKL/OPG ratios', 'Periodontal ligament proliferation and expressions of bone biomolecules', 'PDL volumes']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]","[{'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1529564', 'cui_str': 'RUNX2 protein, human'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0666361', 'cui_str': 'TNFSF11 protein, human'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",18.0,0.0289255,"The median RUNX2 and ALP expression levels were significantly higher at 2 and 4 weeks after preloading than in the unloaded condition ( p < 0.05), whereas the median RANKL/OPG ratios were significantly higher at 1 and 4 weeks after preloading ( p < 0.05). ","[{'ForeName': 'Sasathorn', 'Initials': 'S', 'LastName': 'Phutinart', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}, {'ForeName': 'Suttichai', 'Initials': 'S', 'LastName': 'Krisanaprakornkit', 'Affiliation': 'Department of Oral Biology and Diagnostic Sciences, Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Makeudom', 'Affiliation': 'Center of Excellence in Oral and Maxillofacial Biology, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Boonsiva', 'Initials': 'B', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}, {'ForeName': 'Eduardo Yugo', 'Initials': 'EY', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bangkokthonburi University, Bangkok, Thailand.'}]",Korean journal of orthodontics,['10.4041/kjod.2020.50.3.188'] 3149,32482668,Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial.,"INTRODUCTION There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA. METHODS AND ANALYSIS This study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test. ETHICS AND DISSEMINATION The trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT03360500.",2020,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"['knee osteoarthritis', 'individuals with knee osteoarthritis (KOA', 'patients with KOA']","['Cryotherapy', 'tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol', 'Cryotherapy associated with tailored land-based exercises', 'cryotherapy']","['Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test', 'pain intensity according to a Visual Analogue Scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0887882,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Ogura Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Serafim Jorge', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Regina Mendes da Silva Serrão', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Aburquerque-Sendín', 'Affiliation': 'Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'de Fatima Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035610'] 3150,32482669,Photobiomodulation therapy associated with supervised therapeutic exercises for people with knee osteoarthritis: a randomised controlled trial protocol.,"BACKGROUND Physical exercise, a cornerstone of the conservative management of knee osteoarthritis (KOA), is exhaustively recommended by important clinical guidelines. A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL). Furthermore, photobiomodulation (PBM) has been used as an adjunct treatment for people with KOA; however, there are still controversial recommendations regarding its use on this population. Thus, we hypothesised that PBM, when associated with a STEP protocol on patients with KOA, could induce better clinical outcomes than a STEP protocol alone. METHODS AND ANALYSIS The study is a 6-month triple-blind placebo-controlled randomised clinical trial with intention-to-treat analysis. The trial will include 120 people with clinic and radiographic signs of KOA. The intervention consists of a supervised STEP and PBM protocols conducted over an 8-week intervention period. Assessments are performed at baseline, right after treatment, and 3-month and 6-month follow-up periods. The primary clinical outcome is pain intensity according to a 10 cm Visual Analogue Scale. Secondary outcomes are the global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40 m fast-paced walk test. ETHICS AND DISSEMINATION The trial was approved by the Human Research Ethics Committee of the Federal University of São Carlos, São Paulo, Brazil (REC no 2.016.122). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER Brazilian Clinical Trials Registry (U1111-1215-6510).",2020,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","['people with KOA', 'knee osteoarthritis (KOA', 'people with knee osteoarthritis', '120 people with clinic and radiographic signs of KOA']","['Photobiomodulation therapy', 'strength therapeutic exercise program (STEP', 'photobiomodulation (PBM', 'supervised therapeutic exercises', 'placebo']","['global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40\u2009m fast-paced walk test', 'pain, improves physical function and ultimately ameliorates quality of life (QoL', 'pain intensity according to a 10\u2009cm Visual Analogue Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.105911,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'S Jorge', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'O Dantas', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'M S Serrão', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Instituto Maiomónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Andalucía, Spain.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035711'] 3151,32482112,Effects of anti-osteoporosis therapy on plasma aldosterone and renin.,"OBJECTIVE This study aimed to investigate the effect of anti-osteoporosis therapy on plasma aldosterone concentration (PAC), plasma renin concentration (PRC) and the aldosterone/renin ratio (ARR) in patients with postmenopausal osteoporosis. METHODS In 60 patients with postmenopausal osteoporosis, bone mineral density (BMD), PAC and PRC were measured before and after treatment with alendronate (70 mg/week, n =22) or recombinant human parathyroid hormone (20 μg/day, n =35) for 48 weeks. RESULTS PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r =-0.386, p <0.01; femoral neck r =-0.262, p <0.05). With the improvement in lumbar BMD after anti-osteoporosis treatment (T-score -3.4±0.5 vs. -3.1 ±0.4, p <0.0001), PAC decreased from 182.8±53.2 to 143.7±68.6 pg/mL ( p <0.0001), PRC increased from 7.8±11.6 to 39.2±50.0 μIU/mL ( p <0.0001) and the ARR decreased from 74.8±75.2 to 13.1±17.1 pg/μIU ( p <0.0001). At baseline, 58% (35/60) of the patients had an ARR >37 pg/μIU, and the proportion decreased to 8% (5/57) after treatment. CONCLUSION Treatment with alendronate or parathyroid hormone causes decreased PAC and increased PRC, resulting in a decreased ARR in postmenopausal women with osteoporosis.",2020,"RESULTS PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r","['patients with postmenopausal osteoporosis', 'postmenopausal women with osteoporosis', '60 patients with postmenopausal osteoporosis']","['anti-osteoporosis therapy', 'recombinant human parathyroid hormone', 'alendronate', 'alendronate or parathyroid hormone']","['bone mineral density (BMD), PAC and PRC', 'plasma aldosterone concentration (PAC), plasma renin concentration (PRC) and the aldosterone/renin ratio (ARR', 'T-score of lumbar spine BMD and femoral neck BMD (lumbar r', 'lumbar BMD', 'PRC', 'plasma aldosterone and renin', 'ARR', 'PAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]",60.0,0.0845602,"RESULTS PAC was negatively correlated with the T-score of lumbar spine BMD and femoral neck BMD (lumbar r","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Kangla', 'Initials': 'K', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Longwei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'Department of Endocrinology, the Affiliated Hospital of Guizhou Medical University, PR China.'}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Department of Endocrinology, the People's Hospital of Kaizhou District, PR China.""}, {'ForeName': 'Qifu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}, {'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University, PR China.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320928874'] 3152,32486622,"The effectiveness of interprofessional education programs for medical, nursing, and pharmacy students.","PURPOSE This study is to develop an interprofessional education (IPE) program for medical, nursing, and pharmacy students and to analyze the effectiveness. METHODS Subjects consisted of 116 students (41 medical, 46 nursing, and 29 pharmacy students) enrolled in their final year. Subjects were randomly assigned to either the intervention group or the control group, with 58 in each group. A pretest-posttest control group design was used. The program was operated for a single day, and consisted of small-group activities and role-play. We utilized the following tools: Perceptions towards Interprofessional Education (PIPE), Self-Efficacy for Interprofessional Experiential Learning (SEIEL), and Perception towards Interprofessional Competency (PIC). We used t-test and analysis of covariance for analysis. RESULTS The PIPE tool revealed that the scores of the intervention group were significantly higher than those of the control group (p=0.000). The result was the same when the scores were categorized into the groups medical students (p=0.001), nursing students (p=0.000), and pharmacy students (p=0.005). The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000). However, pharmacy students did not reveal significant (p=0.983). The intervention group scored significantly higher than the control group in the PIC. A concluding survey of the intervention group indicated that most students were satisfied with the IPE program. CONCLUSION We hope this study will provide useful information for designing and improving IPE programs in other universities.",2020,The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000).,"['medical, nursing, and pharmacy students', 'Subjects consisted of 116 students (41 medical, 46 nursing, and 29 pharmacy students) enrolled in their final year']","['interprofessional education programs', 'Interprofessional Experiential Learning (SEIEL), and Perception towards Interprofessional Competency (PIC']",[],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",[],116.0,0.0181828,The SEIEL study also indicated the intervention group scored significantly higher than the control group (p=0.000).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Jung', 'Affiliation': 'Department of Urology, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Kwi Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Yul Ha', 'Initials': 'YH', 'LastName': 'Min', 'Affiliation': 'Gachon University College of Nursing, Incheon, Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Ji', 'Affiliation': 'Gachon University College of Pharmacy, Incheon, Korea.'}]",Korean journal of medical education,['10.3946/kjme.2020.161'] 3153,32487150,"Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study.","BACKGROUND Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. METHODS This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. DISCUSSION The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC. TRIAL REGISTRATION University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.",2020,"The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. ","['adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment', 'opioid-induced constipation', 'Japan in March 2018']","['magnesium oxide with naldemedine', 'magnesium oxide and naldemedine', 'magnesium oxide', 'naldemedine', 'magnesium oxide or naldemedine']","['Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL', 'change in JPAC-QOL score', 'spontaneous bowel movements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",,0.135076,"The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology, International University of Health and Welfare Atami Hospital, 13-1 Higashikaigan-cho, Atami, 413-0012, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Oncology, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Palliative Care Center, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. nakajima-tky@umin.ac.jp.'}]",Trials,['10.1186/s13063-020-04385-0'] 3154,32487157,The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population.,"BACKGROUND Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting smoking, but few smokers use them, and they often use them for too short a time and at an insufficient dose. It is therefore important to increase access to support for smoking cessation and compliance with nicotine therapy. The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants. METHODS Trial design: this is a two-arm, parallel-group, superiority, individually randomized, ""placebo"" controlled trial in 5200 smokers, with follow up after 1 week, 1 month and 6 months. The participants are adult daily smokers (N = 5200) enrolled on the Internet, living in France or Switzerland. The intervention is the Stop-tabac fully-automated app for smartphones, which was launched in 2012 and continuously improved thereafter. It includes fact sheets; calculators of cigarettes not smoked, money saved, and years of life gained; an interactive ""coach"" that provides automated, individually tailored counseling messages based on the user's personal profile, sent regularly for 6 months; immediate feedback during episodes of craving and tobacco withdrawal symptoms; a discussion forum (""The Tribe"") where participants provide and receive social support; a quiz that informs users in a playful way; and a module on nicotine therapy that includes personalized feedback and follow up. The outcome is self-reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), and after 1 week and 1 month (no puff in the past 7 days). Participants will be randomized automatically based on a list of random numbers. Participants, assistants in charge of collecting follow-up data and data analysts will be blinded to allocation. Funding is provided by the Swiss National Science Foundation, CHF 194,942 (EUR 182,200, USD 200,700), grant 32003_179369. JFE's salary is paid by the University of Geneva, YK's salary is paid by the Lausanne University Hospitals. DISCUSSION There is little evidence from randomized trials of the impact of health apps in general and of smoking cessation apps in particular. This study will fill this gap. TRIAL REGISTRATION ISRCTN Registry: ISRCTN11318024. Registered on 17 May 2018.",2020,"The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants. ","['5200 smokers', 'participants are adult daily smokers (N\u2009=\u20095200) enrolled on the Internet, living in France or Switzerland']","['nicotine therapy', 'Nicotine medications', 'Stop-Tabac application (app', 'placebo']","['self-reported smoking cessation', 'chances of quitting smoking']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0045439', 'cui_str': '2,4,6-triiodo-3-acetamidobenzoic acid (N-cyclohexylcarbamyloxy)ethyl ester'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",5200.0,0.11621,"The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants. ","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Etter', 'Affiliation': 'Institute of Global Health, Faculty of Medicine, University of Geneva, 9 chemin des Mines, Campus Biotech, CH-1202, Geneva, Switzerland. Jean-Francois.Etter@unige.ch.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khazaal', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and Lausanne University, Lausanne, Switzerland.'}]",Trials,['10.1186/s13063-020-04377-0'] 3155,32487163,Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial.,"BACKGROUND Rhizarthrosis (trapeziometacarpal osteoarthritis) is the second most common site of osteoarthritis in the hand affecting 10-30% of adults over the age of 50. Up to four times as many women as men have rhizarthrosis. Clinical symptoms include functional disability of the thumb, pain, joint swelling, and reduced strength. The first carpometacarpal joint is pivotal in the opposition of the thumb and allows a high degree in flexibility to humans. Current therapies focus mainly on surgical strategies, which should be considered in advanced, therapy-resistant stages to relieve pain and improve function. However, conservative treatment methods are urgently required in presurgical stages. The efficacy of conservative treatment options for rhizarthrosis, which are intended to preserve function, joint integrity and to relieve pain, has not been adequately studied. In the clinical study protocol presented here, we investigate the efficacy of multimodal hand therapy versus therapeutic ultrasound versus combination therapy with both hand therapy and therapeutic ultrasound. METHODS This study is a single-center, randomized, controlled, parallel-group pilot trial. One hundred fifty patients with rhizarthrosis and current disease activity will be randomized to one of three conservative interventions over 6 months. Interventions are (1) multimodal hand therapy (2) therapeutic ultrasound, and (3) combination therapy with both hand therapy and ultrasound therapy. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months. Secondary endpoints are changes in pain, quality of life, disability progression, and changes of hand function. Safety will also be assessed. DISCUSSION Clinical data suggest that multimodal hand therapy may improve functionality and reduce pain in rhizarthrosis. Clinical data regarding therapeutic ultrasound are not available. Clinical evidence is lacking. This study is the first clinical study investigating the effects of multimodal hand therapy in direct comparison to therapeutic ultrasound and to a combination therapy with both hand therapy and ultrasound therapy for rhizarthrosis. TRIAL REGISTRATION ClinicalTrials.gov; NCT04115085; Registered on September 30, 2019.",2020,"The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months.",['One hundred fifty patients with rhizarthrosis and current disease activity'],"['Medical Ultrasound for Rhizarthrosis (SUR', 'multimodal hand therapy', 'multimodal hand therapy (2) therapeutic ultrasound, and (3) combination therapy with both hand therapy and ultrasound therapy', 'multimodal hand therapy versus therapeutic ultrasound versus combination therapy']","['functional disability of the thumb, pain, joint swelling, and reduced strength', 'changes in pain, quality of life, disability progression, and changes of hand function', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328502', 'cui_str': 'Rhizarthrosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1328502', 'cui_str': 'Rhizarthrosis'}, {'cui': 'C0038944', 'cui_str': 'Suriname'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0513211,"The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score after 6 months.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bock', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany. m.bock@waldfriede.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenschenk', 'Affiliation': 'Department of Hand and Functional Microsurgery, University Medicine Greifswald, Ferdinand-Sauerbruch-Str. 1, 17475, Greifswald, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Lorenzen', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lautenbach', 'Affiliation': 'Department of Hand Surgery, Upper Extremity and Foot Surgery, Center for Orthopedics and Trauma Surgery, Hospital Waldfriede, Argentinische Allee 40, 14163, Berlin, Germany.'}]",Trials,['10.1186/s13063-020-04375-2'] 3156,32487179,The ACCEPT-study: design of an RCT with an active treatment control condition to study the effectiveness of the Dutch version of PEERS® for adolescents with autism spectrum disorder.,"BACKGROUND Social skills interventions are commonly deployed for adolescents with autism spectrum disorder (ASD). Because effective and appropriate social skills are determined by cultural factors that differ throughout the world, the effectiveness of these interventions relies on a good cultural fit. Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention. METHODS/DESIGN This study is a two-arm parallel group randomized controlled trial (RCT) in which adolescents are randomly assigned (after baseline assessment) to one of two group interventions (PEERS® vs. active control condition). In total, 150 adolescents are to be included, with multi-informant involvement of their parents and teachers. The ACCEPT study uses an active control condition (puberty psychoeducation group training, focussing on social-emotional development) and explores possible moderators and mediators in improving social skills. The primary outcome measure is the Contextual Assessment of Social Skills (CASS). The CASS assesses social skills performance in a face to face social interaction with an unfamiliar, typically developing peer, making this a valuable instrument to assess the social conversational skills targeted in PEERS®. In addition, to obtain a complete picture of social skills, self-, parent- and teacher-reported social skills are assessed using the Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2). Secondary outcome measures (i.e. explorative mediators) include social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers. Moreover, demographic and diagnostic measures are assessed as potential moderators of treatment effectiveness. Assessments of adolescents, parents, and teachers take place at baseline (week 0), intermediate (week 7), post intervention (week 14), and at follow-up (week 28). CONCLUSION This is the first RCT on the effectiveness of the PEERS® parent-assisted curriculum which includes an active control condition. The outcome of social skills is assessed using observational assessments and multi-informant questionnaires. Additionally, factors related to social learning are assessed at several time points, which will enable us to explore potential mediators and moderators of treatment effect. TRAIL REGISTRATION Dutch trail register NTR6255 (NL6117). Registered February 8th, 2017 - retrospectively registered.",2020,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention. ","['adolescents with autism spectrum disorder', 'adolescents with autism spectrum disorder (ASD', '150 adolescents are to be included, with multi-informant involvement of their parents and teachers']","['RCT', 'Dutch version of PEERS®', 'active control condition (puberty psychoeducation group training, focussing on social-emotional development', 'group interventions (PEERS® vs. active control condition']","['social skills performance', 'social skills, self-, parent- and teacher-reported social skills', 'Social Skills improvement System (SSiS-RS) and Social Responsiveness Scale (SRS-2', 'social skills', 'social knowledge, social cognition, social anxiety, social contacts and feelings of parenting competency of caregivers', 'Contextual Assessment of Social Skills (CASS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0292637,"Therefore, the ACCEPT study examines the effectiveness of the Dutch Program for the Education and Enrichment of Relational Skills (PEERS®) social skills intervention. ","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'van Pelt', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands. b.vanpelt@erasmusmc.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Idris', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jagersma', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Duvekot', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Yulius Organization for Mental Health, Burg, De Raadtsingel 93c, 3311, JG, Dordrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Ende', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'N E M', 'Initials': 'NEM', 'LastName': 'van Haren', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Greaves-Lord', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015, CN, Rotterdam, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-020-02650-9'] 3157,32487542,"Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study.","BACKGROUND In RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free survival (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety and clinical use of trifluridine/tipiracil. METHODS In this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m 2 twice daily on days 1-5 and 8-12 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included PFS and quality of life (QoL). RESULTS 793 patients (median age 62 years) from 13 countries received trifluridine/tipiracil for a median of 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea. Grade ≥3 AEs occurred in 73.9% of patients, with the most common being neutropaenia (39.1% of patients), anaemia (9.8%) and asthenia/fatigue (5.0%). Median PFS was 2.8 months (95% CI 2.7 to 2.9). Median time to Eastern Cooperative Oncology Group performance status deterioration (≥2) was 8.9 months (range 0.03-14.72). There was no clinically relevant change from baseline in QoL. CONCLUSIONS PRECONNECT showed consistent results with the previously demonstrated safety and efficacy profile of trifluridine/tipiracil, with no new safety concerns identified. QoL was maintained during treatment. TRIAL REGISTRATION NUMBER NCT03306394.",2020,"Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea.","['pretreated metastatic colorectal cancer', 'patients with pretreated metastatic colorectal cancer (mCRC', '793 patients (median age 62 years) from 13 countries received']","['trifluridine/tipiracil', 'oral trifluridine/tipiracil', 'placebo']","['overall survival and progression-free survival (PFS', 'Median PFS', 'asthenia/fatigue', 'QoL', 'Grade ≥3 AEs', 'anaemia', 'Adverse events (AEs', 'PFS and quality of life (QoL', 'neutropaenia', 'Safety, efficacy', 'neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",793.0,0.306629,"Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Hepatogastroenterology, University Hospital Pitié Salpêtrière, Paris, Île-de-France, France jean-baptiste.bachet@aphp.fr.'}, {'ForeName': 'Lucjan', 'Initials': 'L', 'LastName': 'Wyrwicz', 'Affiliation': 'Department of Oncology and Radiotherapy, Maria Skłodowska Curie Memorial Cancer Centre and Institute of Oncology Warsaw, Warszawa, Poland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'Department of Gastroenterology, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, Rhône-Alpes, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Department of Medical Oncology, Institut régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Ozet', 'Affiliation': 'Department of Medical Oncology, Gazi University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Department of Medical Oncology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atlan', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Becquart', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Loick', 'Initials': 'L', 'LastName': 'Vidot', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Nadjat', 'Initials': 'N', 'LastName': 'Mounedji', 'Affiliation': 'Global Medical Affairs, Servier Médical, Suresnes, Île-de-France, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, European Hospital Group Georges-Pompidou, Paris, Île-de-France, France.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Toscana, Italy.'}]",ESMO open,['10.1136/esmoopen-2020-000698'] 3158,32487594,Health literacy and exercise interventions on clinical outcomes in Chinese patients with diabetes: a propensity score-matched comparison.,"INTRODUCTION Patients with diabetes in China have low health literacy, which likely leads to poor clinical outcomes. This study aimed to assess the effectiveness of health literacy and exercise interventions on clinical measurements in Chinese adults with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS A cluster randomized controlled trial was conducted from February 2015 through April 2017 in Shanghai, China. 799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers were randomized into one control arm and three intervention arms receiving 1-year health literacy intervention, exercise intervention or both as the comprehensive intervention. Propensity score matching was employed to minimize potential imbalance in randomization. The intervention-attributable effects on main clinical outcomes were estimated using a difference-in-difference regression approach. RESULTS After propensity score matching, 634 patients were included in the analysis. The three intervention groups had decreased hemoglobin A1c (A1c) level after 12 months of intervention. The largest adjusted decrease was observed in the health literacy group (-0.95%, 95% CI: -1.30 to -0.59), followed by the exercise group (-0.81%, 95% CI: -1.17 to -0.45). However, A1c was observed to increase in the health literacy and the comprehensive groups from 12 to 24 months. No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures. CONCLUSIONS Health literacy and exercise-focused interventions improve glycemic control in Chinese patients with diabetes after 12 months of intervention, and the health literacy intervention shows the greatest effect. Our results suggest that the interventions may have the potential to improve diabetes self-management and reduce diabetes burden in China. TRIAL REGISTRATION NUMBER ISRCTN76130594.",2020,"No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures. ","['Chinese patients with diabetes', 'Patients with diabetes in China have low health literacy', '634 patients were included in the analysis', 'Chinese adults with type 2 diabetes mellitus (T2DM', '799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers', 'February 2015 through April 2017 in Shanghai, China']","['Health literacy and exercise interventions', 'health literacy and exercise interventions', '1-year health literacy intervention, exercise intervention or both as the comprehensive intervention', 'Health literacy and exercise-focused interventions']","['high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures', 'hemoglobin A1c (A1c) level', 'health literacy']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",799.0,0.066618,"No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures. ","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingyao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Yingnan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Division of Clinical and Administrative Science, College of Pharmacy, Xavier University of Louisiana, Louisiana, New Orleans, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': 'Key Lab of Health Technology Assessment (National Health Commission), School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Global Health Management and Policy, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Wanghong', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Key Laboratory of Public Health Safety (National Ministry of Education), Fudan University, Shanghai, China wanghong.xu@fudan.edu.cn.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001179'] 3159,32488427,Physiologically Based Dissolution Testing in a Drug Development Process-a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions.,"Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the development of a generic trazodone ER formulation that was aided with a biorelevant dissolution evaluation. Trazodone hydrochloride 300-mg monolithic matrix tablets were dissolved both in USP and EMA compliant conditions and in the StressTest device that simulated both physicochemical and mechanical conditions of the gastrointestinal passage. The final formulation was tested against the originator, Trittico XR 300 mg, in a randomized cross-over bioequivalence trial with 44 healthy volunteers, in agreement with EMA guidelines. Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests. The formulation was optimized by the addition of low-viscosity hypromellose and mannitol. The final formulation was approved for the bioequivalence trial. Calculated C max were 1.92 ± 0.77 and 1.92 ± 0.63 [μg/mL], AUC 0-t were 27.46 ± 8.39 and 29.96 ± 9.09 [μg∙h/mL], and AUC 0-∞ were 28.22 ± 8.91 and 30.82 ± 9.41 [μg∙h/mL] for the originator and test formulations, respectively. The 90% confidence intervals of all primary pharmacokinetic parameters fell within the 80-125% range. In summary, biorelevant dissolution tests supported successful development of a generic trazodone ER formulation pharmaceutically equivalent with the originator under fed conditions. Employment of biorelevant dissolution tests may decrease the risk of failure in bioequivalence trials of ER formulations.",2020,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.",['44 healthy volunteers'],"['trazodone', 'generic trazodone ER formulation', 'Trazodone ER Formulations', 'Trazodone hydrochloride', 'low-viscosity hypromellose and mannitol']",['dissolution kinetics'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}]",44.0,0.107498,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.","[{'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Danielak', 'Affiliation': 'Department of Physical Pharmacy and Pharmacokinetics, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Święcickiego st, 60-781, Poznań, Poland. danielak@ump.edu.pl.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Milanowski', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wentowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nogowska', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kątny', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rogowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Konwicki', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Puk', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Pieczuro', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bawiec', 'Affiliation': 'Institute of Computer Engineering, Control and Robotics, Wroclaw University of Technology, 27 Wybrzeże Wyspańskiego st, 50-370, Wrocław, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Garbacz', 'Affiliation': 'Physiolution GmbH, Walther-Rathenau Strasse 49a, 17489, Greifswald, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Lulek', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}]",AAPS PharmSciTech,['10.1208/s12249-020-01662-8'] 3160,32483186,The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.,"Management of intermittent allergic rhinitis (IAR) is suboptimal in the UK. An Australian community pharmacy-based intervention has been shown to help patients better self-manage their IAR. We conducted a pilot cluster RCT in 12 Scottish community pharmacies to assess transferability of the Australian intervention. Trained staff in intervention pharmacies delivered the intervention to eligible customers (n = 60). Non-intervention pharmacy participants (n = 65) received usual care. Outcome measures included effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) between baseline, 1-week and 6-week follow-up. Trial procedures were well received by pharmacy staff, and customer satisfaction with the intervention was high. The standardised effect size for miniRQLQ total score was -0.46 (95% CI, -1.05, 0.13) for all participants and -0.14 (95% CI,-0.86, 0.57) in the complete case analysis, suggesting a small overall treatment effect in the intervention group. A full-scale RCT is warranted to fully evaluate the effectiveness of this service.",2020,The standardised effect size for miniRQLQ total score was -0.46,"['12 Scottish community pharmacies to assess transferability of the Australian intervention', 'intermittent allergic rhinitis (IAR']",['usual care'],"['miniRQLQ total score', 'effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ']","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]",[],"[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.163936,The standardised effect size for miniRQLQ total score was -0.46,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Porteous', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. t.porteous@abdn.ac.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bond', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'School of Health Sciences, City, University of London, Northampton Square, London, EC1V 0HB, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lowrie', 'Affiliation': 'Pharmacy Research and Development Team, Pharmacy and Prescribing Support Unit, West Glasgow Ambulatory Care Hospital, Glasgow, G3 8SJ, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Institute of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Allergy and Respiratory Research Group, Centre for Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, 27 Bute Gardens, Glasgow, G12 8RS, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Faculty of Pharmacy, Building A15, The University of Sydney, Camperdown, NSW, 2006, Australia.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-0180-4'] 3161,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952'] 3162,32479559,Effects of singing bowl exposure on Karolinska sleepiness scale and pupillographic sleepiness test: A randomised crossover study.,"BACKGROUND The aim of this study was to investigate the effects on subjective and objective sleepiness of a stay above a large struck singing bowl compared to a relaxation period in a silent singing bowl. METHODS Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot. The Karolinska sleepiness scale was used to evaluate current subjective sleepiness, and the relative pupillary unrest index to assess objective sleepiness. In this randomized cross-over study, the intervention consisted of a 20-minute stay in a hammock while the singing bowl, positioned beneath, was struck seven times. The controlled comparator was a 20-minute stay in the same hammock above the singing bowl, but without being struck. After these two interventions subjective and objective sleepiness were re-evaluated. RESULTS The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71 (p = 0.460). The median Karolinska sleepiness scale value after relaxation with the struck singing bowl was 3 compared with 4 (p = 0.041) for the silent singing bowl. DISCUSSION This study evaluated the influence of a struck singing bowl on sleepiness during daytime. Subjective sleepiness was significantly lower after relaxation above a struck singing bowl. After gender stratification, the difference was still significant in women. Objective sleepiness was not different in both groups. Finally, we can only speculate if women may be more susceptible to subjective improvements in case of sleepiness and show another perception of relaxation in a struck singing bowl compared to men.",2020,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"['Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot']","['singing bowl exposure', 'struck singing bowl']","['Karolinska sleepiness scale', 'mean relative pupillary unrest index values', 'Karolinska sleepiness scale and pupillographic sleepiness test', 'Objective sleepiness', 'Subjective sleepiness', 'median Karolinska sleepiness scale value']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0858854', 'cui_str': 'Unrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",58.0,0.0151798,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Riedinger', 'Affiliation': 'Department of Therapeutic Radiology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mitterling', 'Affiliation': 'Department of Neurology 1, Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grassmayr', 'Affiliation': 'Bell Foundry Grassmayr, Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}]",PloS one,['10.1371/journal.pone.0233982'] 3163,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939'] 3164,32481390,A controlled study on the efficacy and quality of life of laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE) in the treatment of extremely low rectal cancer.,"BACKGROUND The aim of this study is to compare the postoperative quality of life (QoL) and survival outcomes in lower rectal cancer (LRC) patients who undergo either laparoscopic- intersphincteric resection or extralevator abdominoperineal excision (L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT). METHODS This prospective, single-center, non-randomized, controlled, non-blinded, phase I/II clinical trial is designed to enroll 159 eligible LRC patients who achieved favorable response to long-course nCRT (2 × 25 Gy). After informed consent, the patients will be assigned into the laparoscopic intersphincteric resection group or L-ELAPE group according to their own will. Standard radical laparoscopic surgeries will be performed for every participant. Then every participant will be followed up for 3 years. The primary outcomes are scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5 (for male) and Female Sexual Function Index (for female). The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes. DISCUSSION This is the first prospective clinical controlled trial to assess postoperative QoL and efficacy for LRC patients after favorable long-course nCRT. The result is expected to provide new evidence for a more detailed individualized treatment guideline for LRC. TRIAL REGISTRATION This trial was registered at Chinese Clinical Trial Registry (ChiCTR1800017512; ChiCTR.org) on August 2, 2018.",2020,"The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes. ","['159 eligible LRC patients who achieved favorable response to long-course nCRT (2\u200a×\u200a25 Gy', 'extremely low rectal cancer', 'lower rectal cancer (LRC) patients who undergo either', 'LRC patients after favorable long-course nCRT', 'for male) and Female Sexual Function Index (for female', 'L-ELAPE) after long-course neoadjuvant chemoradiation therapy (nCRT']","['laparoscopic- intersphincteric resection or extralevator abdominoperineal excision', 'laparoscopic intersphincteric resection group or L-ELAPE', 'Standard radical laparoscopic surgeries', 'laparoscopic intersphincteric resection (ISR) and extralevator abdominoperineal resection (ELAPE']","['scores of QoL questionnaire-core 30, QoL questionnaire-colorectum 29, Wexner incontinence score, International Prostate Symptom Score (for male), International Index of Erectile Function-5', 'postoperative QoL and efficacy', 'incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes', 'postoperative quality of life (QoL) and survival outcomes']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.149055,"The secondary outcomes consist of incomplete circumferential resection margin rate, 3-year local recurrence, 3-year disease-free survival, 3-year overall survival and other surgical outcomes. ","[{'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, West China-Shangjin Hospital of Sichuan University/Chengdu Shangjin Nanfu Hospital, No. 253 Shangjin Road, Chengdu, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital of Sichuan University, No. 37 Guoxue Lane, Chengdu.'}, {'ForeName': 'Cun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Yongyang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}, {'ForeName': 'Zongguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital of Sichuan University.'}]",Medicine,['10.1097/MD.0000000000020245'] 3165,32486934,Rituximab use as induction therapy for lupus nephritis: a systematic review.,"OBJECTIVE Rituximab (RTX) has important usage in rheumatoid arthritis and vasculitis. There remains a need for more, better, and safer treatments for patients with lupus nephritis (LN). RTX has been trialed in such patients without definitive conclusions about its effectiveness. As a role for RTX has not been clearly established for LN, we carried out a systematic review and analysis. METHODS We identified 31 studies of RTX for class I-VI LN, and assessed complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment. Due to differences in the pediatric presentation of the disease, studies focusing on pediatric patients were excluded. RESULTS One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR). Six prospective and retrospective studies utilizing RTX monotherapy found 66% CRR or PRR in all patients. Eleven studies that investigated RTX in combination with CYC or mycophenolate mofetil (MMF) also found 66% CRR or PRR in all patients. In total, the CRR for Caucasian, East Asian, and Hispanic patients were 77%, 38%, and 28%, respectively. CONCLUSIONS RTX appeared to benefit certain LN patients, but most studies were not randomized or properly controlled, were heterogeneous in design, subjects, and LN types, and were not comparable, and must therefore be interpreted cautiously. RTX alone may not deplete B cells sufficiently for the perturbations of LN. In addition, RTX may induce responses differently among patients of different ethnic and racial backgrounds. Furthermore, there were wide variations in the baseline characteristics of the patients, namely LN class, time course of disease, age, and prior immunosuppressive use. We suggest a prospective RCT in patients aged 18-65 years with class IV LN. Ideally, the patients would not have received prior immunosuppression and would better represent different ethnicities. The treatment groups would be RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids during induction followed by maintenance steroids and MMF. The CRR and PRR would be assessed at 12 and 24 months. This or a similar study might clarify RTX's role in the treatment of LN.",2020,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"['patients with lupus nephritis (LN', 'lupus nephritis', 'patients aged 18-65 years with class IV LN']","['Rituximab (RTX', 'Rituximab', 'mycophenolate mofetil (MMF', 'RTX', 'RTX, RTX+belimumab, CYC, and MMF groups, with pulse-dose steroids', 'RTX monotherapy', 'RTX+cyclophosphamide (CYC) versus CYC']","['complete renal response (CRR) and partial renal response (PRR) using criteria including serum creatinine, proteinuria, and urinary sediment', 'CRR and PRR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1261248', 'cui_str': 'Urine sediment'}]",,0.0609728,One randomized controlled trial (RCT) showed superiority of RTX+cyclophosphamide (CYC) versus CYC alone (64% vs. 21% CRR and 19% vs. 36% PRR).,"[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Stolyar', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Lahita', 'Affiliation': ""Department of Medicine, St. Joseph's Regional Medical Centre, Paterson, USA.""}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Panush', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, USA.'}]",Lupus,['10.1177/0961203320928412'] 3166,32487024,The effect of a dementia awareness class on changing dementia attitudes in adolescents.,"BACKGROUND Current evidence suggests that negative and stigmatising attitudes towards dementia may develop at a young age. There are a number of dementia education and awareness initiatives aimed at reducing stigma, though they have not been robustly evaluated to establish the impact on dementia attitudes or suitability in adolescent populations. This study explored the efficacy and satisfaction of one such initiative (Dementia Friends) in a British adolescent sample. METHODS 301 adolescents (M = 12.6 years old, SD = 0.73) were assigned to either receive Dementia Friends (a 60-min interactive class that teaches about dementia and its effects on people's lives) or education as usual. All participants completed a series of validated questionnaires pre- and post-intervention, related to dementia attitudes (Brief A-ADS and KIDS). RESULTS Adolescents in the dementia awareness group showed little to no improvements between time-points. The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures. There was no Group x Time effect after controlling for confounding variables. CONCLUSIONS Dementia Friends is successful in terms of reach and impact, though this study suggests that it may fall short of achieving its goal of improving attitudes towards dementia. Importantly, Dementia Friends did not have a negative effect on attitudes, and the majority of adolescents enjoyed the sessions. It is important that these findings are replicated in a larger randomised-controlled study.",2020,"The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures.","['301 adolescents (M\u2009=\u200912.6\u2009years old, SD\u2009=\u20090.73', 'adolescents', 'British adolescent sample']","['dementia awareness class', 'Dementia Friends']",['dementia attitudes (Brief A-ADS and KIDS'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",301.0,0.0324211,"The change scores in the dementia awareness group did not significantly differ to the control group based on both KIDS (d = - 0.003, p = 0.98) and Brief A-ADS (d = 0.14, p = 0.13) measures.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Farina', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RY, UK. N.farina@bsms.ac.uk.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hughes', 'Affiliation': 'Centre for Dementia Studies, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9RY, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Brighton and Hove Dementia Action Alliance, Brighton, UK.'}, {'ForeName': 'Sahdia', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Alys W', 'Initials': 'AW', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Galvin', 'Affiliation': 'School of Health Sciences, University of Brighton, Brighton, UK.'}, {'ForeName': 'Sube', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Faculty of Health, University of Plymouth, Plymouth, UK.'}]",BMC geriatrics,['10.1186/s12877-020-01589-6'] 3167,32487033,A convenient clinical nomogram for predicting the cancer-specific survival of individual patients with small-intestine adenocarcinoma.,"BACKGROUND The objective of this study was to develop a practical nomogram for predicting the cancer-specific survival (CSS) of patients with small-intestine adenocarcinoma. METHODS Patients diagnosed with small-intestine adenocarcinoma between 2010 and 2015 were selected for inclusion in this study from the Surveillance, Epidemiology, and End Results (SEER) database. The selected patients were randomly divided into the training and validation cohorts at a ratio of 7:3. The predictors of CSS were identified by applying both forward and backward stepwise selection methods in a Cox regression model. The performance of the nomogram was measured by the concordance index (C-index), the area under receiver operating characteristic curve (AUC), calibration plots, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and decision-curve analysis (DCA). RESULTS Multivariate Cox regression indicated that factors including age at diagnosis, sex, marital status, insurance status, histology grade, SEER stage, surgery status, T stage, and N stage were independent covariates associated with CSS. These factors were used to construct a predictive model, which was built and virtualized by a nomogram. The C-index of the constructed nomogram was 0.850. The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS. The IDI and NRI also showed that the nomogram exhibited superior performance in both the training and validation cohorts. Furthermore, the calibrated nomogram predicted survival rates that closely corresponded to actual survival rates, while the DCA demonstrated the considerable clinical usefulness of the nomogram. CONCLUSION We have constructed a nomogram for predicting the CSS of small-intestine adenocarcinoma patients. This prognostic model may improve the ability of clinicians to predict survival in individual patients and provide them with treatment recommendations.",2020,The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS.,"['Patients diagnosed with small-intestine adenocarcinoma between 2010 and 2015 were selected for inclusion in this study from the Surveillance, Epidemiology, and End Results (SEER) database', 'patients with small-intestine adenocarcinoma', 'small-intestine adenocarcinoma patients', 'individual patients with small-intestine adenocarcinoma']",[],"['survival rates', 'cancer-specific survival (CSS', 'concordance index (C-index), the area under receiver operating characteristic curve (AUC), calibration plots, the net reclassification improvement (NRI), the integrated discrimination improvement (IDI), and decision-curve analysis (DCA', 'actual survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0278803', 'cui_str': 'Adenocarcinoma of small intestine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0276047,The AUC values indicated that the established nomogram displayed better discrimination performance than did the seventh edition of the American Joint Committee on Cancer TNM staging system in predicting CSS.,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Department of Clinical Research, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Clinical Research Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'School of Nursing and Health, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'School of Nursing and Health, Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Xuequn', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Center for Evidence-Based Medicine and Clinical Research, Huaihe Hospital of Henan University, Kaifeng, Henan, China. hhyyrxq@126.com.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China. victor7922@163.com.'}]",BMC cancer,['10.1186/s12885-020-06971-6'] 3168,32487035,Ipilimumab or FOLFOX with Nivolumab and Trastuzumab in previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma - the randomized phase 2 INTEGA trial (AIO STO 0217).,"BACKGROUND Esophagogastric adenocarcinoma (EGA) currently represents a main cause of cancer related death. Despite an intensified treatment for locally advanced or metastatic EGA with a doublet chemotherapy consisting of a platinum compound and a fluoropyrimidine in combination with trastuzumab for HER2-positive disease or in selected cases with docetaxel, survival remains poor. Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA. Notably, the combination of immunotherapy with trastuzumab to enhance anti-tumor immunity through activation of innate and adaptive immunity was beneficial in preclinical studies or clinical studies in breast cancer. METHODS The INTEGA study is an open-label, randomized, multicenter, exploratory phase II trial designed to assess clinical performance, safety and tolerability of ipilimumab or 5-FU/folinic acid and oxaliplatin (FOLFOX) in combination with nivolumab and trastuzumab in patients with previously untreated HER2-positive, locally advanced or metastatic EGA. The primary objective is to determine the clinical performance of ipilimumab or FOLFOX in combination with nivolumab and trastuzumab in terms of overall survival. Secondary objectives are safety and tolerability, efficacy in terms of progression-free survival and objective response rate and blood-based signatures (e.g. immune response or suppression of anti-HER2 resistance) that may correlate with treatment response. DISCUSSION Recent evidence from the phase II NCT02954536 study (oxaliplatin, capecitabine, trastuzumab and pembrolizumab) suggests the clinical feasibility of combining chemotherapy, trastuzumab and checkpoint inhibition in EGA. However, evidence for a chemotherapy-free regimen is also mounting in HER2-positive disease (NCT02689284) i.e. margetuximab and Pembrolizumab. Both studies excelled with high overall response rates and manageable toxicities. The INTEGA study aims to comparatively assess these results and select a promising new 1st line regimen which then needs to be confirmed in a randomized phase III trial. Further, the translational part of the study might help to better stratify patients and tailor treatment of either arm. TRIAL REGISTRATION NCT03409848 24.01.2018.",2020,"Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA.","['Esophagogastric adenocarcinoma (EGA', 'previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma', 'patients with previously untreated HER2-positive, locally advanced or metastatic EGA']","['nivolumab and trastuzumab', 'Ipilimumab or FOLFOX with Nivolumab and Trastuzumab', 'immunotherapy with trastuzumab', 'fluoropyrimidine in combination with trastuzumab', 'oxaliplatin, capecitabine, trastuzumab and pembrolizumab', 'ipilimumab or FOLFOX', 'ipilimumab or 5-FU/folinic acid and oxaliplatin (FOLFOX']","['clinical performance, safety and tolerability', 'manageable toxicities', 'safety and tolerability, efficacy in terms of progression-free survival and objective response rate and blood-based signatures (e.g. immune response or suppression of anti-HER2 resistance', 'overall survival']","[{'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0682981,"Recently, immune-oncology based strategies relevantly improved the treatment of different solid tumors and showed some promise in late or later stage trials in EGA.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tintelnot', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Eray', 'Initials': 'E', 'LastName': 'Goekkurt', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Binder', 'Affiliation': 'University Hospital Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Charité, University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Rechts der Isar Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jorge Riera', 'Initials': 'JR', 'LastName': 'Knorrenschild', 'Affiliation': 'University Hospital of Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': 'MVZ Mitte, Practice for Hematology and Oncology, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Lindig', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Practice of Hematology and Oncology, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pink', 'Affiliation': 'Helios Clinic Bad Saarow, Bad Saarow, Germany and University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Krankenhaus Nordwest, UCT University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC, Düsseldorf, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'Hematology-Oncology Practice Hamburg (HOPE), Hamburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine II (Oncology Center), University Medical Center Hamburg-Eppendorf, Hubertus Wald Tumorzentrum/UCCH, Martinistr. 52, 20246, Hamburg, Germany. a.stein@uke.de.'}]",BMC cancer,['10.1186/s12885-020-06958-3'] 3169,32487264,Natural outcome of hemoglobin and functional recovery after the direct anterior versus the posterolateral approach for total hip arthroplasty: a randomized study.,"BACKGROUND Total hip arthroplasty (THA) is one of the most successful orthopedic surgeries. There are many common surgical approaches for THA. The direct anterior approach (DAA) and posterolateral approach (PLA) were compared, leading to controversial results. METHODS We report on a prospective randomized study which compared the changes of perioperative hemoglobin (Hb), the Harris hip score (HHS) and a visual analog scale (VAS) pain score following THA using DAA or PLA. A total of 130 participants were randomly divided into two groups (65 DAA versus 65 PLA). Perioperative ΔHb and other clinical outcomes were recorded. RESULTS A total of 130 participants completed follow-up, while 14 patients were not recorded in blood outcomes due to blood transfusions and complications. The average Hb decrease immediately after surgery in the DAA group was greater than that in the PLA group (21.1 versus 15.8 g/L, P < .001). However, post-operative Hb descent velocity was slower in the DAA group, and the lowest point was reached earlier. No significant differences in ΔHb levels could be observed after 1 month in the two groups. When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004). However, the operation time of the DAA group was longer (88.0 versus 66.8 min, P < .001). The DAA group had a better HHS and VAS pain score at 6 weeks post-surgery. However, no significant differences were observed at later time points. CONCLUSION We concluded that DAA performed better on enhanced recovery after surgery (ERAS) than PLA in THA, while both DAA and PLA could result in a positive, similar result after 3 months. TRIAL REGISTRATION The study was registered by the Chinese Clinical Trial Registry (ChiCTR1900020770, 19 January 2019).",2020,"When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004).","['A total of 130 participants', 'total hip arthroplasty']","['DAA', 'direct anterior approach (DAA) and posterolateral approach (PLA', 'PLA', 'direct anterior versus the posterolateral approach', 'THA using DAA or PLA', 'Total hip arthroplasty (THA']","['blood outcomes due to blood transfusions and complications', 'shorter incision', 'shorter hospital stay', 'ΔHb levels', 'post-operative Hb descent velocity', 'hemoglobin and functional recovery', 'perioperative hemoglobin (Hb), the Harris hip score (HHS) and a visual analog scale (VAS) pain score', 'HHS and VAS pain score', 'operation time']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",130.0,0.0832761,"When compared with the PLA group, the DAA group had a shorter incision (9.1 versus 13.5 cm, P < .001) and shorter hospital stay (4.2 versus 4.7 days, P = .004).","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Yiqin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xin', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. lother@163.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. wangbo229000@sina.com.'}, {'ForeName': 'Qirong', 'Initials': 'Q', 'LastName': 'Qian', 'Affiliation': 'Department of Joint Surgery and Sports Medicine, Shanghai Changzheng Hospital, Second Military Medical University, No.415, Fengyang Road, Shanghai, 200003, China. qianqr@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01716-4'] 3170,32484818,The impact of a high-quality basic life support police-based first responder system on outcome after out-of-hospital cardiac arrest.,"BACKGROUND Laypersons' efforts to initiate basic life support (BLS) in witnessed Out-of-Hospital Cardiac Arrest (OHCA) remain comparably low within western society. Therefore, in order to shorten no-flow times in cardiac arrest, several police-based first responder systems equipped with automated external defibrillators (Pol-AED) were established in urban areas, which subsequently allow early BLS and AED administration by police officers. However, data on the quality of BLS and AED use in such a system and its impact on patient outcome remain scarce and inconclusive. METHODS A total of 85 Pol-AED cases were randomly assigned to a gender, age and first rhythm matched non-Pol-AED control group (n = 170) in a 1:2 ratio. Data on quality of BLS were extracted via trans-thoracic impedance tracings of used AED devices. RESULTS Comparing Pol-AED cases and the control group, we observed a similar compression rate per minute (p = 0.677) and compression ratio (p = 0.651), mirroring an overall high quality of BLS administered by police officers. Time to the first shock was significantly shorter in Pol-AED cases (6 minutes [IQR: 2-10] vs. 12 minutes [IQR: 8-17]; p<0.001). While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj. OR: 1.85 [95%CI: 1.06-3.23; p = 0.030]) and a borderline significance for the association with favorable neurological outcome (adj. OR: 1.58 [95%CI: 0.96-2.89; p = 0.052) were observed. CONCLUSION We were able to demonstrate an early start and a high quality of BLS and AED use in Pol-AED assessed OHCA cases. Moreover, the presence of Pol-AED care was associated with better patient survival and borderline significance for favorable neurological outcome.",2020,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.",['A total of 85 Pol-AED cases'],['high-quality basic life support police-based first responder system'],"['compression rate per minute', 'quality of BLS', 'survival until hospital discharge', 'compression ratio', 'sustained return of spontaneous circulation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]",170.0,0.0618399,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Krammel', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lobmeyr', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sulzgruber', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winnisch', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weidenauer', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poppe', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Datler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zeiner', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Keferboeck', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Eichelter', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamp', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uray', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schnaubelt', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nuernberger', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",PloS one,['10.1371/journal.pone.0233966'] 3171,32485641,"Caloric restriction, resting metabolic rate and cognitive performance in Non-obese adults: A post-hoc analysis from CALERIE study.","Physical activity (PA) has been proposed as a determinant of cognitive function and is one component of energy balance (EB). EB is the difference between energy intake (EI) and the total daily energy expenditure (TDEE). TDEE is a combination of resting metabolic rate (RMR), thermic effect of food and PA. The potential role of each of these components on cognitive function has not yet been systemically investigated. We aim to evaluate the association between each component of EB on cognition, using baseline and longitudinal data from a clinical trial of caloric restriction (CR). This is a parallel-group, randomized clinical trial comparing two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI ≥ 22 kg/m2 and <28 kg/m2. Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content were evaluated, as well as RMR, TDEE, cognitive performance and baseline energy intake. A 30 min/day of a moderate level on a minimum of 5 days/week was advised as PA measure. Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass. EB and homeostasis are crucial to modulate the RMR. Moreover, RMR presents an important influence on cognitive function in individuals submitted to CR in a long term.",2020,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","['two years of 25% CR with two years of ad libitum diet (AL), with 220 healthy volunteers of both sex, aged between 21 and 50 years and initial BMI', 'Non-obese adults']","['TDEE', 'Physical activity (PA', 'caloric restriction (CR']","['cognitive performance', 'RMR, TDEE, cognitive performance and baseline energy intake', 'total daily energy expenditure (TDEE', 'cognitive function', 'resting metabolic rate (RMR), thermic effect of food and PA', 'Body weight, fat mass (FM), fat-free mass (FFM), and bone mineral content', 'cognitive performance and the RMR', 'Caloric restriction, resting metabolic rate and cognitive performance']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]",220.0,0.044031,"Longitudinal analysis demonstrated that the influence of CR in the improvement of cognitive performance was moderated by changes in RMR, suggesting that in individuals submitted to CR, the cognitive performance and the RMR improved proportionally, independently of changes in EI and body mass.","[{'ForeName': 'Ruth Bartelli', 'Initials': 'RB', 'LastName': 'Grigolon', 'Affiliation': 'Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Post-Graduation Program in Psychiatry, Universidade Federal de São Paulo, São Paulo, SP, Brazil; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies (CNS), Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Alisson Paulino', 'Initials': 'AP', 'LastName': 'Trevizol', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention and Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Brain and Cognition Foundation, Toronto, ON, Canada.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, Toronto Western Hospital, University Health Network, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. Electronic address: rodrigomansur71@uol.com.br.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.05.018'] 3172,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD. METHODS In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy. RESULTS The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). CONCLUSIONS The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082'] 3173,32482174,Using the axillary reverse mapping technique to screen breast cancer patients with a high risk of lymphedema.,"BACKGROUND Preventing breast cancer-related lymphedema (BCRL) by preserving upper lymphatic drainage is still controversial. Our study aimed to use the axillary reverse mapping (ARM) technique in patients who underwent axillary surgery to analyse the correlation between postoperative residual ARM nodes and the occurrence of lymphedema, select candidates at high risk of developing lymphedema, and analyse the oncologic safety of ARM nodes. METHODS Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study. ARM was performed in all patients before surgery. ARM nodes were separated from SLNB and ALND specimens. Data were collected on the identification of ARM nodes before surgery, number of residual ARM nodes after surgery, nodal status, crossover rate, and correlation between residual ARM nodes and the occurrence of lymphedema. RESULTS The analysis included 78 patients. Of the 53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens. The incidence of ARM node metastasis was 1.89% (1/53) and 25% (9/36) in the SLNB and ALND groups, respectively. The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036). The incidence of residual ARM nodes was significantly higher in the SLNB group than in the ALND group (67.6% vs. 37.9%, P = 0.016). The incidence of lymphedema was significantly higher in the ALND group than in the SLNB group (33.3% vs. 5.4%, P = 0.003). CONCLUSIONS For SLNB, the ARM technique can help to resect SLNs more accurately. However, we do not recommend using the ARM technique to preserve ARM nodes in patients undergoing ALND due to oncologic safety issues. Nevertheless, we can predict patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes. TRIAL REGISTRATION This study was registered on ClinicalTrials.gov in February 2016. The clinical trial registration number is NCT02691624.",2020,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"['patients undergoing axillary surgery who are more likely to have a high risk of lymphedema by assessing residual ARM nodes', '78 patients', ""Patients undergoing sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) from October 2015 to February 2016 at the Peking University People's Hospital Breast Center were prospectively recruited for the study"", 'patients who underwent axillary surgery', 'screen breast cancer patients with a high risk of lymphedema', '53 patients who underwent SLNB, crossover between ARM nodes and breast sentinel lymph nodes (SLNs) was seen in 22 specimens']","['ALND', 'axillary reverse mapping (ARM) technique', 'SLNB', 'axillary reverse mapping technique']","['number of positive axillary lymph nodes', 'incidence of lymphedema', 'incidence of residual ARM nodes', 'incidence of ARM node metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0594634,The number of positive axillary lymph nodes was associated with the involvement of ARM nodes (P = 0.036).,"[{'ForeName': 'Siyao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Houpu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. liumiao@pkuph.edu.cn.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Breast Center, Peking University People's Hospital, Beijing, China. shuwang@pkuph.edu.cn.""}]",World journal of surgical oncology,['10.1186/s12957-020-01886-9'] 3174,32487180,Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial.,"BACKGROUND Need-oriented family support programs are examples of voluntary-based interventions increasingly recognized by the public sector as an important contribution to health and social care provision. Voluntary interventions are attractive because of their focus on activism, inclusion, and participation, but also their low cost and easy accessibility. There is an increasing demand for documentation of the effectiveness of family support programs. Methodologically sound studies are, however, limited and findings are generally inconsistent. This trial aims to assess the effectiveness of the volunteer-based intervention Family Club Denmark on parental stress, mental health, development and well-being of parents and children and to get insight into the experiences of both volunteers and families. METHODS This is a prospective quasi-experimental trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are families with children aged 2-12 years who wish to participate in the program. Participants are allocated to intervention primarily after a first-come-first-serve principle, and further families will join the wait-list and be offered participation after around 6 months. Quantitative data are collected through web surveys at three time-points: at baseline, post-intervention (6 months after baseline), and follow-up (12 months after baseline). The primary outcome is mental health. Secondary outcomes include parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being. Qualitative data are collected through observations, focus groups, and interviews. DISCUSSION This trial is among the first experimental studies of a group-based third sector need-oriented family support program offered to a wide array of families. The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines. Furthermore, the trial will provide knowledge on volunteer, parent, and child experiences with participating in the intervention and knowledge on how to conduct experimental trails in a complex volunteer environment. TRIAL REGISTRATION ClinicalTrials.govNCT03657888 (registered 29.08.2018).",2020,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","['Participants are families with children aged 2-12\u2009years who wish to participate in the program', 'Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families']","['intervention group participating in Family Club Denmark and (2) wait-list control group', 'volunteer-based intervention Family Club Denmark']","['mental health', 'parenting behavior, parenting stress, self-efficacy and self-worth, family routines and child well-being']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]",,0.0487298,"The trial will provide important knowledge on the effectiveness of a volunteer-based family intervention on important outcomes such as mental health, self-efficacy, family routines.","[{'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark. mpo@vive.dk.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thorsager', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Arendse Tange', 'Initials': 'AT', 'LastName': 'Larsen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Friis-Hansen', 'Affiliation': 'VIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 5200, Copenhagen, Denmark.'}]",BMC psychology,['10.1186/s40359-020-00426-0'] 3175,32487184,Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419).,"BACKGROUND Fatigue is one of the most common and distressing side-effects of breast cancer radiotherapy. According to current guidelines, accelerated partial breast irradiation (APBI) may be considered as an alternative treatment option for women with early-stage low-risk breast cancer. One method for APBI is single-dose intraoperative radiotherapy (IORT) applied directly to the tumor bed during breast conserving surgery (BCS). The COSMOPOLITAN trial therefore aims to analyze the intensity of fatigue following single-shot IORT with electrons (IOERT) compared to conventional hypofractionated whole breast irradiation (WBI) in low risk early breast cancer patients. METHODS This trial is conducted as a multicenter, prospective, randomized, two-arm phase II study comparing the intensity of fatigue in early-stage breast cancer (cT1cN0cM0, tumor size < 2,5 cm, ER pos. Her2neu neg., age > 50 years) treated either with WBI or APBI after BCS. Secondary outcomes investigated are tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis. A total of 202 patients will be randomized into two arms: Patients in arm A will receive WBI (40.05 Gy, 15 fractions) after surgical resection, while patients in arm B will receive IOERT (21 Gy to the 90%-isodose) during BCS. Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. DISCUSSION The present trial aims to evaluate treatment response to compare single-shot intraoperative electron APBI to conventional WBI following BCS in early-stage low risk breast cancer patients. Fatigue is selected as the primary, patient-reported endpoint due its major clinical relevance. TRIAL REGISTRATION The study is prospectively registered on February 12th, 2019: Clinicaltrials.gov, NCT03838419. ""Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer (COSMOPOLITAN)"". STUDY STATUS Ongoing study. Start of recruitment was December 2019.",2020,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. ","['low risk early breast cancer patients', 'women with early-stage low-risk breast cancer', 'low-risk early breast cancer', 'early-stage low risk breast cancer patients', '202 patients']","['radiotherapy', 'conventional hypofractionated whole breast irradiation (WBI', 'Intraoperative Electron Radiotherapy', 'intraoperative radiotherapy (IORT', 'WBI or APBI', 'intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy', 'single-shot intraoperative electron APBI to conventional WBI following BCS', 'IOERT', 'single-shot IORT with electrons (IOERT', 'accelerated partial breast irradiation (APBI']","['Chronic Illness Therapy (FACIT) Fatigue Scale', 'tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis', 'Fatigue']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0013852', 'cui_str': 'Electron'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C3896696', 'cui_str': 'Accelerated partial breast irradiation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",202.0,0.13722,"Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. ","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Forster', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Jäkel', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sati', 'Initials': 'S', 'LastName': 'Akbaba', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krempien', 'Affiliation': 'Department of Radiation Oncology, Helios Hospital Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Matthias Felix', 'Initials': 'MF', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Stefan Alexander', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Semi', 'Initials': 'S', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Hennigs', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Sohn', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Department of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hörner-Rieber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. juliane.hoerner-rieber@med.uni-heidelberg.de.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01581-9'] 3176,32487210,"Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).","BACKGROUND Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.",2020,"In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.","['patients with PUGIF', 'upper gastrointestinal fistula after surgery', '321 patients will be enrolled']","['total parenteral nutrition (TPN', 'Enteral versus parenteral nutrition', 'TPN', 'EN versus TPN', 'PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation', 'enteral nutrition (EN']","['30-day and 6-month postrandomization mortality rate, nutritional status', '30-day fistula closure rate', 'fistula-related complication rate', '6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate', ""mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment"", 'length of hospital stay, reduced health-related quality of life and increased health costs', 'late fistula-related complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0450198', 'cui_str': 'Duodenojejunal'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0441508', 'cui_str': 'Fistula repair'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",321.0,0.0556466,"In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gronnier', 'Affiliation': 'Department of Visceral Surgery, Centre Médico-chirurgical Magellan, Pessac, France. caroline.gronnier@chu-bordeaux.fr.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chambrier', 'Affiliation': 'Department of Nutrition and Intestinal Rehabilitation, Lyon Sud University Hospital, Pierre-Bénite, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Pôle de Santé Publique, Department of Biostatistic, University Hospital of Lille, Lille, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': 'Maison Régionale de la Recherche Clinique, Hospitalière et Universitaire - CHRU de Lille, Lille, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Visceral Surgery, Centre Médico-chirurgical Magellan, Pessac, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Vaudoyer', 'Affiliation': 'Department of Visceral Surgery, Lyon Sud University Hospital, Pierre-Bénite, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Régimbeau', 'Affiliation': 'Department of Visceral Surgery, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Jougon', 'Affiliation': 'Department of Thoracic Surgery, Centre Médico-chirurgical Magellan, Bordeaux University Hospital, Pessac, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Théréaux', 'Affiliation': 'Department of Visceral Surgery, Hospital Center Regional University, Brest, France.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Lebreton', 'Affiliation': 'Department of Visceral Surgery, Caen University Hospital, Caen, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Veziant', 'Affiliation': 'Department of Visceral Surgery, Gabriel-Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Valverde', 'Affiliation': 'Department of Visceral Surgery, Diaconesses Hospital, Paris, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ortega-Deballon', 'Affiliation': 'Department of Visceral Surgery, University Hospital Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pattou', 'Affiliation': 'Department of Visceral and Endocrine Surgery, Huriez University Hospital, Lille, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Mathonnet', 'Affiliation': 'Department of Visceral Surgery, Dupuytren University Hospital, Limoges, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Perinel', 'Affiliation': 'Department of Visceral Surgery, Edouard Herriot University Hospital, Lyon, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beyer-Berjot', 'Affiliation': 'Department of Visceral Surgery, Hôpital Nord, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Department of Visceral Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': 'Department of Visceral Surgery, Institut Regional Cancer Montpellier, Montpellier, France.'}, {'ForeName': 'Jérémie H', 'Initials': 'JH', 'LastName': 'Lefevre', 'Affiliation': 'Department of Visceral Surgery, Saint-Antoine University Hospital, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cattan', 'Affiliation': 'Department of Visceral Surgery, Saint-Louis University Hospital, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Deguelte', 'Affiliation': 'Department of Visceral Surgery, Robert Debré University Hospital, Reims, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Visceral Surgery, Pontchaillou University Hospital, Rennes, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Visceral Surgery, Rouen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Pessaux', 'Affiliation': 'Department of Visceral Surgery, Nouvel Hôpital Civil, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrere', 'Affiliation': 'Department of Visceral Surgery, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Salame', 'Affiliation': 'Department of Visceral Surgery, Tours, France.'}, {'ForeName': 'Eleonor', 'Initials': 'E', 'LastName': 'Benaim', 'Affiliation': 'Department of Visceral Surgery, Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Department of Visceral Surgery, Cochin Hospital, Paris, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of Visceral Surgery, Bichat Hospital, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Lille University Hospital, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04366-3'] 3177,32487213,"The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study).","BACKGROUND Approximately 30% of appendectomies are for complicated acute appendicitis (CAA). With laparoscopy, the main post-operative complication is deep abscesses (12% of cases of CAA, versus 4% for open surgery). A recent cohort study compared short and long courses of postoperative antibiotic therapy in patients with CAA. There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)). Moreover, antibiotic therapy is increasingly less indicated for other situations (non-complicated appendicitis, post-operative course of cholecystitis, perianal abscess), calling into question whether post-operative antibiotic therapy is required after laparoscopic appendectomy for CAA. METHODS/DESIGN This study is a prospective, multicenter, parallel-group, randomized (1:1), double-blinded, placebo-controlled, phase III non-inferiority study with blind evaluation of the primary efficacy criterion. The primary objective is to evaluate the impact of the absence of post-operative antibiotic therapy on the organ/space surgical site infection (SSI) rate in patients presenting with CAA (other than in cases of generalized peritonitis). Patients in the experimental group will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, a placebo for ceftriaxone (2 g/24 h in one intravenous injection) and a placebo for metronidazole (1500 mg/24 h in three intravenous injections, for 3 days). In the control group, patients will receive at least one dose of preoperative and perioperative antibiotic therapy (2 g ceftriaxone by intravenous injection every 24 h up to the operation) and metronidazole (500 mg by intravenous injection every 8 h up to the operation) and, in the post-operative period, antibiotic therapy (ceftriaxone 2 g/24 h and metronidazole 1500 mg/24 h for 3 days). In the event of allergy to ceftriaxone, it will be replaced by levofloxacin (500 mg/24 h in one intravenous injection, for 3 days). The expected organ space SSI rate is 12% in the population of patients with CAA operated on by laparoscopy. With a non-inferiority margin of 5%, a two-sided alpha risk of 5%, a beta risk of 20%, and a loss-to-follow-up rate of 10%, the calculated sample size is 1476 included patients, i.e., 738 per group. Due to three interim analyses at 10%, 25%, and 50% of the planned sample size, the total sample size increases to 1494 patients (747 per arm). TRIAL REGISTRATION Ethical authorization by the Comité de Protection des Personnes and the Agence Nationale de Sécurité du Médicament: ID-RCB 2017-00334-59. Registered on ClinicalTrials.gov (NCT03688295) on 28 September 2018.",2020,There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)).,"['patients presenting with CAA (other than in cases of generalized peritonitis', 'patients with CAA', 'complicated acute appendicitis']","['placebo for metronidazole', 'post-operative antibiotic therapy', 'RCB', 'metronidazole', 'laparoscopic appendectomy', 'postoperative antibiotic therapy', 'antibiotic therapy (ceftriaxone 2\u2009g/24\u2009h and metronidazole', 'levofloxacin', 'placebo for ceftriaxone', 'perioperative antibiotic therapy (2\u2009g ceftriaxone', 'preoperative and perioperative antibiotic therapy (2\u2009g ceftriaxone', 'ceftriaxone', 'antibiotic therapy', 'placebo']","['organ/space surgical site infection (SSI) rate', 'post-operative complication rate', 'organ space SSI rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C3662314', 'cui_str': 'Organ-space surgical site infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.149827,There was no significant intergroup difference in the post-operative complication rate (12% of organ/space surgical site infection (SSI)).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Siembida', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dupont', 'Affiliation': 'Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diouf', 'Affiliation': 'Department of Methodology, Biostatistics, Direction of Clinical Research, Amiens University Medical Center, Amiens, France.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Schmit', 'Affiliation': 'Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boddaert', 'Affiliation': 'Department of Pharmacology, Amiens University Medical Center, Amiens, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Regimbeau', 'Affiliation': 'Department of Digestive Surgery, Amiens University Hospital, Amiens University Medical Center, Avenue Laennec, F-80054, Amiens cedex 01, France. regimbeau.jean-marc@chu-amiens.fr.'}]",Trials,['10.1186/s13063-020-04411-1'] 3178,32485294,Immunological and behavioral responses to in vivo lipopolysaccharide administration in young and healthy obese and normal-weight humans.,"Obesity is associated with an increase prevalence of neuropsychiatric symptoms and diseases, such as depression. Based on the facts that pro-inflammatory cytokines are able to modulate behavior, and that obesity is characterized by a chronic low-grade inflammatory state, inflammation has been hypothesized to contribute to the neuropsychiatric comorbidity in obese individuals. However, a causal link between inflammation and the development of neuropsychiatric symptoms is hard to establish in humans. Here, we used an inflammatory stimulus, i.e. the intravenous injection of lipopolysaccharide (LPS), in a double-blind placebo-controlled design, to determine the vulnerability of obese individuals to inflammation-induced behavioral changes. The hypothesis was that obese individuals would show heightened behavioral response compared to normal-weight subjects for the same inflammatory stimulus, reflecting an increased sensitivity to the behavioral effects of pro-inflammatory cytokines. LPS (dose 0.8 ng/kg body weight, adjusted for estimated blood volume in obese subjects) and placebo (saline) were intravenously injected in 14 obese healthy subjects and 23 normal-weight healthy subjects in a within-subject, randomized, crossover design. LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α, and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood, and state anxiety. There were little differences in the immune and behavioral responses to LPS between obese and normal-weight subjects, but the cortisol response to LPS was strongly attenuated in obese individuals. Higher percentage of body fat was related to a lower cortisol response to LPS. Taken together, the population of young and healthy obese individuals in this study did not exhibit an increased behavioral sensitivity to cytokines, but an attenuated cortisol response to the immune challenge. Future studies will need to determine whether additional physiological and psychological factors interact with the state of obesity to increase the risk for inflammation-induced neuropsychiatric symptoms.",2020,"LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety.","['obese individuals to inflammation-induced behavioral changes', 'obese individuals', 'young and healthy obese and normal-weight humans', '14 obese healthy subjects and 23 normal-weight healthy subjects']","['placebo (saline', 'lipopolysaccharide administration', 'lipopolysaccharide (LPS', 'LPS']","['Immunological and behavioral responses', 'blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety', 'behavioral response', 'cortisol response to LPS']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",14.0,0.0574229,"LPS administration induced, in both groups, an acute increase in blood concentrations of cytokines (interleukin-6, tumor necrosis factor-α and IL-10), as well as in body temperature, cortisol, norepinephrine, sickness symptoms, fatigue, negative mood and state anxiety.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hebebrand', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Boy', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Weskamp', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Analena', 'Initials': 'A', 'LastName': 'Handke', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Hasenberg', 'Affiliation': 'Helios Adipositas Zentrum West, Helios St. Elisabeth Klinik Oberhausen, Witten/Herdecke University, Josefstr. 3, 46045 Oberhausen, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Remy', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Föcker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Duisburg-Essen, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Unteroberdörster', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Department of Neurosurgery, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brinkhoff', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany; Department of Nephrology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.05.071'] 3179,32485769,"[A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma - SUNNIFORECAST AN 41/16 der AUO].",,2020,,['Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma - SUNNIFORECAST AN 41/16 der AUO'],['Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy'],[],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0160919,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rexer', 'Affiliation': 'AUO Geschäftsstelle, Seestr. 11, 17252 Schwarz, AUO@MeckEvidence.de.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Leiter der klinischen Prüfung (LKP), Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590 Frankfurt.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Organgruppensprecher der Arbeitsgemeinschaft Urologische Onkologie in der Deutschen Krebsgesellschaft e. V., Kuno-Fischer-Str. 8, 14057 Berlin.'}]",Aktuelle Urologie,['10.1055/a-1079-7621'] 3180,32487250,Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial.,"BACKGROUND In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. METHODS Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes. DISCUSSION Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings. TRIAL REGISTRATION Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.",2020,"This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. ","['pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care', 'Consenting participants', 'pregnant women experiencing IPV in low- and middle-income countries', 'Prospectively registered on 13 December 2019', 'Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia', 'pregnant women experiencing IPV in rural Ethiopia']","['PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care', 'Problem solving therapy (PST', 'problem solving therapy (PST', 'standard PST']","['depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0205444', 'cui_str': 'Tenth'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",75.0,0.174148,"This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial. ","[{'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Keynejad', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Tesera', 'Initials': 'T', 'LastName': 'Bitew', 'Affiliation': 'College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sorsdahl', 'Affiliation': 'Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol Tobacco and Other Drug Use Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Girmay', 'Initials': 'G', 'LastName': 'Medhin', 'Affiliation': 'Aklilu-Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Sevdalis', 'Affiliation': ""Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. charlotte.hanlon@kcl.ac.uk.""}]",Trials,['10.1186/s13063-020-04331-0'] 3181,32487263,Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers.,"BACKGROUND The rational use of antibiotics is one of the main strategies to limit the development of bacterial resistance. We therefore sought to evaluate the effectiveness of a C-reactive protein-based protocol in reducing antibiotic treatment time in critically ill patients. METHODS A randomized, open-label, controlled clinical trial conducted in two intensive care units of a university hospital in Brazil. Critically ill infected adult patients were randomly allocated to (i) intervention to receive antibiotics guided by daily monitoring of CRP levels and (ii) control to receive antibiotics according to the best practices for rational use of antibiotics. RESULTS One hundred thirty patients were included in the CRP (n = 64) and control (n = 66) groups. In the intention-to-treat analysis, the median duration of antibiotic therapy for the index infectious episode was 7.0 (5.0-8.8) days in the CRP and 7.0 (7.0-11.3) days in the control (p = 0.011) groups. A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007). In the per protocol analysis, involving 59 patients in each group, the median duration of antibiotic treatment was 6.0 (5.0-8.0) days for the CRP and 7.0 (7.0-10.0) days for the control (p = 0.011) groups. There was no between-group difference regarding the total days of antibiotic exposure and antibiotic-free days. CONCLUSIONS Daily monitoring of CRP levels may allow early interruption of antibiotic therapy in a higher proportion of patients, without an effect on total antibiotic consumption. The clinical and microbiological relevance of this finding remains to be demonstrated. TRIAL REGISTRY ClinicalTrials.gov Identifier: NCT02987790. Registered 09 December 2016.",2020,"A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007).","['critically ill patients', 'two intensive care units of a university hospital in Brazil', 'Critically ill infected adult patients', 'One hundred thirty patients were included in the CRP (n\u2009=\u200964) and control (n\u2009=\u200966) groups']","['antibiotics guided by daily monitoring of CRP levels and (ii) control to receive antibiotics according to the best practices for rational use of antibiotics', 'C-reactive protein-based protocol', 'antibiotic therapy']","['median duration of antibiotic treatment', 'median duration of antibiotic therapy for the index infectious episode', 'total antibiotic consumption', 'curve of cumulative suspension of antibiotics', 'total days of antibiotic exposure and antibiotic-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",130.0,0.0993665,"A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007).","[{'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Borges', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. isabelanborges@gmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Carneiro', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bergo', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Graduate Program in Statistics, Department of Statistics, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colosimo', 'Affiliation': 'Graduate Program in Statistics, Department of Statistics, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Saturnino', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcus Vinícius', 'Initials': 'MV', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program in Health Sciences: Adult Health, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ravetti', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Vandack', 'Initials': 'V', 'LastName': 'Nobre', 'Affiliation': 'Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-02946-y'] 3182,32490686,Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.,"Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 (ClinicalTrials.gov).",2020,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"['patients with locally advanced HNSCC', 'patients with locally advanced disease', 'patients with locally advanced head and neck squamous cell carcinoma (HNSCC', 'locally advanced head and neck squamous cell carcinoma']","['chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy', 'CRT', 'pembrolizumab', 'Pembrolizumab', 'pembrolizumab or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.158035,The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials.,"[{'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Machiels', 'Affiliation': 'Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Department of Medicine, Yale University School of Medicine & Yale Cancer Center, 333 Cedar Street, New Haven, CT 06510, USA.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, 6-Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 27-8577, Japan.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Via Giacomo Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Waldron', 'Affiliation': 'Department of Radiation Oncology University of Toronto, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital CHUV, Rue du Bugnon 21, 1011, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gregoire', 'Affiliation': 'Department of Radiation Oncology, Centre Leon Berard, 28 Prom. Lea et Napoleon Bullukian, 69008, Lyon, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Harrington', 'Affiliation': 'Division of Radiotherapy & Imaging, The Institute of Cancer Research, London, SW3 6JB, UK.'}, {'ForeName': 'Gustavo Vasconcelos', 'Initials': 'GV', 'LastName': 'Alves', 'Affiliation': 'Centro Integardo de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Avenida Francisco Trein, 596 - Cristo Redentor Porto Alegre - RS, 91350-200, Brazil.'}, {'ForeName': 'Iane Pinto', 'Initials': 'IP', 'LastName': 'Figueiredo Lima', 'Affiliation': 'Crio Centro Regional Integrado de Oncologia, R. Francisco Calaca, 1300 - Alvaro Weyne, Fortaleza - CE, 60335-480, Brazil.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Department of Radiation Oncology, Institut Inter-Regional de Cancerologie-Centre Jean Bernard/Clinique Victor Hugo, 72000, Le Mans, France.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'M Hughes', 'Affiliation': ""Cancer Care Services, Royal Brisbane & Women's Hospital, Butterfield Street, Herston QLD 4029, Australia & School of Medicine, University of Queensland, 20 Weightman Street, Herston, QLD, 4006, Australia.""}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Aksoy', 'Affiliation': 'Hacettepe University, Cancer Institute, Department of Medical Oncology, 06100, Ankara, Turkey.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Hetnal', 'Affiliation': 'Faculty of Medicine & Health Sciences, Andrzej Frycz Modrzewski Krakow University, Amethyst Radiotherapy Centre, Rydygier Hospital, Krakow, Poland, Złotej Jesieni 1, Krakow, Poland.'}, {'ForeName': 'Joy Y', 'Initials': 'JY', 'LastName': 'Ge', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Bidadi', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.'}, {'ForeName': 'Lillian L', 'Initials': 'LL', 'LastName': 'Siu', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.'}]","Future oncology (London, England)",['10.2217/fon-2020-0184'] 3183,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association. METHOD As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data. RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women. CONCLUSIONS Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474'] 3184,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels. METHODS The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141. RESULTS The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. CONCLUSIONS Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162'] 3185,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS). OBJECTIVE To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters. METHODS Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria. RESULTS Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05). CONCLUSION Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203'] 3186,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs. MATERIALS AND METHODS This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively. FINDINGS The AUC of Model LBC for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US. INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777'] 3187,21404370,Variability of fMRI-response patterns at different spatial observation scales.,"Functional organization units of the cerebral cortex exist over a wide range of spatial scales, from local circuits to entire cortical areas. In the last decades, scale-space representations of neuroimaging data suited to probe the multi-scale nature of cortical functional organization have been introduced and methodologically elaborated. For this purpose, responses are statistically detected over a range of spatial scales using a family of Gaussian filters, with small filters being related to fine and large filters-to coarse spatial scales. The goal of the present study was to investigate the degree of variability of fMRI-response patterns over a broad range of observation scales. To this aim, the same fMRI data set obtained from 18 subjects during a visuomotor task was analyzed with a range of filters from 4- to 16-mm full width at half-maximum (FWHM). We found substantial observation-scale-related variability. For example, using filter widths of 6- to 8-mm FWHM, in the group-level results, significant responses in the right secondary visual but not in the primary visual cortex were detected. However, when larger filters were used, the responses in the right primary visual cortex reached significance. Often, responses in probabilistically defined areas were significant when both small and large filters, but not intermediate filter widths were applied. This suggests that brain responses can be organized in local clusters of multiple distinct activation foci. Our findings illustrate the potential of multi-scale fMRI analysis to reveal novel features in the spatial organization of human brain responses.",2012,"However, when larger filters were used, the responses in the right primary visual cortex reached significance.",['18 subjects during a visuomotor task was analyzed with a range of filters from 4- to 16-mm full width at half-maximum (FWHM'],[],[],"[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",[],[],,0.0293703,"However, when larger filters were used, the responses in the right primary visual cortex reached significance.","[{'ForeName': 'Tonio', 'Initials': 'T', 'LastName': 'Ball', 'Affiliation': 'Epilepsy Center, University Hospital Freiburg, Germany. tonio.ball@uniklinik-freiburg.de'}, {'ForeName': 'Thomas P K', 'Initials': 'TP', 'LastName': 'Breckel', 'Affiliation': ''}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Mutschler', 'Affiliation': ''}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Aertsen', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schulze-Bonhage', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Speck', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21274'] 3188,32493506,Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],"['indomethacin and prophylactic pancreatic stent placement', 'Rectal indomethacin']",[],[],"[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C2747855', 'cui_str': 'Pancreatic stent placement'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]",[],,0.0368255,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'B Joseph', 'Initials': 'BJ', 'LastName': 'Elmunzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Serrano', 'Affiliation': 'Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amitabh', 'Initials': 'A', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Edmundowicz', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Papachristou', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Scheiman', 'Affiliation': 'Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Vikesh K', 'Initials': 'VK', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Vargo', 'Affiliation': 'Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Todd H', 'Initials': 'TH', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Coté', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romagnuolo', 'Affiliation': 'Tidelands Health, Murrels Inlet, SC, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wood-Williams', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Depue', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Spitzer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Durkalski', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04458-0'] 3189,32493514,"A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES SARS-CoV2 infection leads to a concomitant pulmonary inflammation. This inflammation is supposed to be the main driver in the pathogenesis of lung failure (Acute Respiratory Distress Syndrome) in COVID-19. Objective of this study is to evaluate the efficacy and safety of a single dose treatment with Tocilizumab in patients with severe COVID-19. We hypothesize that Tocilizumab slows down the progression of SARS-CoV-2 induced pneumonia and inflammation. We expect an improvement in pulmonary function compared to placebo-treated patients. Desirable outcomes would be that tocilizumab reduces the number of days that patients are dependent on mechanical ventilation and reduces the invasiveness of breathing assistance. Furthermore, this treatment might result in fewer admissions to intensive care units. Next to these efficacy parameters, safety of a therapy with Tocilizumab in COVID-19 patients has to be monitored closely, since immunosuppression could lead to an increased rate of bacterial infections, which could negatively influence the patient's outcome. TRIAL DESIGN Multicentre, prospective, 2-arm randomised (ratio 1:1), double blind, placebo-controlled trial with parallel group design. PARTICIPANTS Inclusion criteria 1.Proof of SARS-CoV2 (Symptoms and positive polymerase chain reaction (PCR))2.Severe respiratory failure: a.Ambient air SpO 2 ≤ 92% orb.Need of ≥ 6l O2/min orc.NIV (non-invasive ventilation) ord.IMV (invasive mechanical ventilation)3.Age ≥ 18 years Exclusion criteria 1.Non-invasive or invasive mechanical ventilation ≥ 48 hours2.Pregnancy or breast feeding3.Liver injury or failure (AST/ALT ≥ 5x ULN)4.Leukocytes < 2 × 10 3 /μl5.Thrombocytes < 50 × 10 3 /μl6.Severe bacterial infection (PCT > 3ng/ml)7.Acute or chronic diverticulitis8.Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone ≤ 10mg/d, sulfasalazine or hydroxychloroquine)9.Known active or chronic tuberculosis10.Known active or chronic viral hepatitis11.Known allergic reactions to tocilizumab or its ingredients12.Life expectation of less than 1 year (independent of COVID-19)13.Participation in any other interventional clinical trial within the last 30 days before the start of this trial14.Simultaneous participation in other interventional trials (except for participation in COVID-19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed15.Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception. The data collection of the primary follow up (28 days after randomisation) takes place during the hospital stay. Subsequently, a telephone interview on the quality of life is conducted after 6 and 12 months. Participants will be recruited from inpatients at ten medical centres in Germany. INTERVENTION AND COMPARATOR Intervention arm: Application of 8mg/kg body weight (BW) Tocilizumab i.v. once immediately after randomisation (12 mg/kg for patients with <30kg BW; total dose should not exceed 800 mg) AND conventional treatment. Control arm: Placebo (NaCl) i.v. once immediately after randomisation AND conventional treatment. MAIN OUTCOMES Primary endpoint is the number of ventilator free days (d) (VFD) in the first 28 days after randomisation. Non-invasive ventilation (NIV), Invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation (ECMO) are defined as ventilator days. VFD's are counted as zero if the patient dies within the first 28 days. RANDOMISATION The randomisation code will be generated by the CTU (Clinical Trials Unit, ZKS Freiburg) using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff. Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre. The block lengths will be documented separately and will not be disclosed to the investigators. The randomisation code will be produced by validated programs based on the Statistical Analysis System (SAS). BLINDING (MASKING) Participants, caregivers, and the study team assessing the outcomes are blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 100 participants will be randomised to each group (thus 200 participants in total). TRIAL STATUS Protocol Version: V 1.2, 16.04.2020. Recruitment began 27th April 2020 and is anticipated to be completed by December 2020. TRIAL REGISTRATION The trial was registered before trial start in trial registries (EudraCT: No. 2020-001408-41, registered 21st April 2020, and DRKS: No. DRKS00021238, registered 22nd April 2020). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre.,"['18 years Exclusion criteria 1.Non-invasive or invasive mechanical ventilation ≥ 48 hours2.Pregnancy or breast feeding3.Liver injury or failure', 'Participants will be recruited from inpatients at ten medical centres in Germany', '2020-001408-41, registered 21st April 2020, and DRKS', 'COVID-19 patients', 'patients with severe COVID-19 pneumonia (TOC-COVID', '100 participants will be randomised to each group (thus 200 participants in total', 'Inclusion criteria 1.Proof of SARS-CoV2 (Symptoms and positive polymerase chain reaction (PCR))2.Severe respiratory failure: a', 'patients with severe COVID-19']","['IMV (invasive mechanical ventilation)3.Age ≥', 'mycophenolate, azathioprine, methotrexate, biologicals, prednisolone ', 'tocilizumab', 'sulfasalazine or hydroxychloroquine)9.Known active or chronic tuberculosis10.Known active', '8mg/kg body weight (BW) Tocilizumab i.v', 'Tocilizumab', 'Placebo (NaCl) i.v', 'prednisolone', 'placebo']","['quality of life', 'invasive ventilation (NIV), Invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation (ECMO', 'number of ventilator free days (d) (VFD', 'invasiveness of breathing assistance', 'efficacy and safety', 'pulmonary function']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1835664', 'cui_str': 'Tylosis with esophageal cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1301757', 'cui_str': 'Invasiveness'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",100.0,0.594759,Randomisation will be stratified by centre and will be performed in blocks of variable length in a ratio of 1:1 within each centre.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rilinger', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany. jonathan.rilinger@uniklinik-freiburg.de.'}, {'ForeName': 'Winfried V', 'Initials': 'WV', 'LastName': 'Kern', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duerschmied', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Supady', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Dawid L', 'Initials': 'DL', 'LastName': 'Staudacher', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wengenmayer', 'Affiliation': 'Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.'}]",Trials,['10.1186/s13063-020-04447-3'] 3190,30846854,"Development of patient ""profiles"" to tailor counseling for incidental genomic sequencing results.","Guidelines recommend that providers engage patients in shared decision-making about receiving incidental results (IR) prior to genomic sequencing (GS), but this can be time-consuming, given the myriad of IR and variation in patients' preferences. We aimed to develop patient profiles to inform pre-test counseling for IR. We conducted semi-structured interviews with participants as a part of a randomized trial of the GenomicsADvISER.com, a decision aid for selecting IR. Interviews explored factors participants considered when deliberating over learning IR. Interviews were analyzed by thematic analysis and constant comparison. Participants were mostly female (28/31) and about half of them were over the age of 50 (16/31). We identified five patient profiles that reflect common contextual factors, attitudes, concerns, and perceived utility of IR. Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"". Concerned Individuals defined themselves as ""anxious,"" and were reluctant to learn IR, anticipating negative psychological impacts from IR. Contemplators were discerning about the value and limitations of IR, weighing health benefits with the impacts of not being able to ""un-know"" information. Individuals of Advanced Life Stage did not consider IR relevant for themselves and primarily considered their implications for family members. Reassurance Seekers were reassured by previous negative genetic test results which shaped their expectations for receiving no IR: ""hopefully [GS will] be negative, too. And then I can rest easy"". These profiles could inform targeted counseling for IR by providing a framework to address common values, concerns. and misconceptions.",2019,"Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"".",['Participants were mostly female (28/31) and about half of them were over the age of 50 (16/31'],[],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}]",[],[],,0.0159349,"Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"".","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McCuaig', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Joshi', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Winter-Paquette', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lorentz', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ott', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Silberman', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0352-2'] 3191,27935229,Cortico-limbic connectivity in MAOA-L carriers is vulnerable to acute tryptophan depletion.,"INTRODUCTION A gene-environment interaction between expression genotypes of the monoamine oxidase A (MAOA) and adverse childhood experience increases the risk of antisocial behavior. However, the neural underpinnings of this interaction remain uninvestigated. A cortico-limbic circuit involving the prefrontal cortex (PFC) and the amygdala is central to the suppression of aggressive impulses and is modulated by serotonin (5-HT). MAOA genotypes may modulate the vulnerability of this circuit and increase the risk for emotion regulation deficits after specific life events. Acute tryptophan depletion (ATD) challenges 5-HT regulation and may identify vulnerable neuronal circuits, contributing to the gene-environment interaction. METHODS Functional magnetic resonance imaging measured the resting-state state activity in 64 healthy males in a double-blind, placebo-controlled study. Cortical maps of amygdala correlation identified the impact of ATD and its interaction with low- (MAOA-L) and high-expression variants (MAOA-H) of MAOA on cortico-limbic connectivity. RESULTS Across all Regions of Interest (ROIs) exhibiting an ATD effect on cortico-limbic connectivity, MAOA-L carriers were more susceptible to ATD than MAOA-H carriers. In particular, the MAOA-L group exhibited a larger reduction of amygdala connectivity with the right prefrontal cortex and a larger increase of amygdala connectivity with the insula and dorsal PCC. CONCLUSION MAOA-L carriers were more susceptable to a central 5-HT challenge in cortico-limbic networks. Such vulnerability of the cortical serotonergic system may contribute to the emergence of antisocial behavior after systemic challenges, observed as gene-environment interaction. Hum Brain Mapp 38:1622-1635, 2017. © 2016 Wiley Periodicals, Inc.",2017,MAOA-L carriers were more susceptable to a central 5-HT challenge in cortico-limbic networks.,['64 healthy males'],['placebo'],['amygdala connectivity'],"[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}]",64.0,0.03424,MAOA-L carriers were more susceptable to a central 5-HT challenge in cortico-limbic networks.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Eisner', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klasen', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Dhana', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Zerres', 'Affiliation': 'Department of Human Genetics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eggermann', 'Affiliation': 'Department of Human Genetics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Eisert', 'Affiliation': 'Department of Pharmacy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Zvyagintsev', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Sarkheil', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Krystyna A', 'Initials': 'KA', 'LastName': 'Mathiak', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zepf', 'Affiliation': 'Department of Child and Adolescent Psychiatry, School of Psychiatry and Clinical Neurosciences and School of Pediatrics and Child Health; Faculty of Medicine, Dentistry and Health Sciences; The University of Western Australia (M561), Perth, Australia.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mathiak', 'Affiliation': 'Department of Psychiatry, Psychotherapy, and Psychosomatics, Medical School, RWTH Aachen University, Aachen, Germany.'}]",Human brain mapping,['10.1002/hbm.23475'] 3192,27729597,An early parallel group trial in cardiology.,,2016,,[],[],[],[],[],[],,0.118135,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hampton', 'Affiliation': 'Department of Cardiology, Nottingham University, Nottingham NG7 2UH, UK jrhampton@doctors.org.uk.'}]",Journal of the Royal Society of Medicine,[] 3193,26609096,"The Swedish randomised controlled trial on mammography screening has been properly designed, conducted and analysed.",,2015,,[],['mammography screening'],[],[],"[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",[],,0.0881394,,"[{'ForeName': 'Lennarth', 'Initials': 'L', 'LastName': 'Nyström', 'Affiliation': 'Umeå University, Umeå SE-90187, Sweden Lennarth.Nystrom@umu.se.'}]",Journal of the Royal Society of Medicine,['10.1177/0141076815616090'] 3194,23281174,Spatial heterogeneity of the relation between resting-state connectivity and blood flow: an important consideration for pharmacological studies.,"Resting state fMRI (RSfMRI) and arterial spin labeling (ASL) provide the field of pharmacological Neuroimaging tool for investigating states of brain activity in terms of functional connectivity or cerebral blood flow (CBF). Functional connectivity reflects the degree of synchrony or correlation of spontaneous fluctuations--mostly in the blood oxygen level dependent (BOLD) signal--across brain networks; but CBF reflects mean delivery of arterial blood to the brain tissue over time. The BOLD and CBF signals are linked to common neurovascular and hemodynamic mechanisms that necessitate increased oxygen transportation to the site of neuronal activation; however, the scale and the sources of variation in static CBF and spatiotemporal BOLD correlations are likely different. We tested this hypothesis by examining the relation between CBF and resting-state-network consistency (RSNC)--representing average intranetwork connectivity, determined from dual regression analysis with eight standard networks of interest (NOIs)--in a crossover placebo-controlled study of morphine and alcohol. Overall, we observed spatially heterogeneous relations between RSNC and CBF, and between the experimental factors (drug-by-time, time, drug and physiological rates) and each of these metrics. The drug-by-time effects on CBF were significant in all networks, but significant RSNC changes were limited to the sensorimotor, the executive/salience and the working memory networks. The post-hoc voxel-wise statistics revealed similar dissociations, perhaps suggesting differential sensitivity of RSNC and CBF to neuronal and vascular endpoints of drug actions. The spatial heterogeneity of RSNC/CBF relations encourages further investigation into the role of neuroreceptor distribution and cerebrovascular anatomy in predicting spontaneous fluctuations under drugs.",2014,"The drug-by-time effects on CBF were significant in all networks, but significant RSNC changes were limited to the sensorimotor, the executive/salience and the working memory networks.",[],"['morphine and alcohol', 'Resting state fMRI (RSfMRI) and arterial spin labeling (ASL']","['executive/salience and the working memory networks', 'functional connectivity or cerebral blood flow (CBF']",[],"[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",8.0,0.0219033,"The drug-by-time effects on CBF were significant in all networks, but significant RSNC changes were limited to the sensorimotor, the executive/salience and the working memory networks.","[{'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Khalili-Mahani', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands; Department of Radiology, Leiden University Medical Center (LUMC), Leiden, The Netherlands; Leiden Institute for Brain and Cognition (LIBC), Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Matthias J', 'Initials': 'MJ', 'LastName': 'van Osch', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'de Rooij', 'Affiliation': ''}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Beckmann', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'van Buchem', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': ''}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'van Gerven', 'Affiliation': ''}, {'ForeName': 'Serge A R B', 'Initials': 'SA', 'LastName': 'Rombouts', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.22224'] 3195,30674702,Mobile self-compassion programme for promotion of public mental health: a randomised controlled trial.,,2019,,['public mental health'],['Mobile self-compassion programme'],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",[],,0.234923,,"[{'ForeName': 'W W S', 'Initials': 'WWS', 'LastName': 'Mak', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'C C Y', 'Initials': 'CCY', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'A T Y', 'Initials': 'ATY', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong.'}, {'ForeName': 'J T F', 'Initials': 'JTF', 'LastName': 'Lau', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong.'}]",Hong Kong medical journal = Xianggang yi xue za zhi,[] 3196,31411989,"Re: Christopher C. Parker, Nicholas D. James, Christopher D. Brawley, et al. Radiotherapy to the Primary Tumour for Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE): A Randomised Controlled Phase 3 Trial. Lancet 2018;392:2353-66: Metastatic Hormone-naïve Prostate Cancer: A Multimodal Approach for a Heterogeneous Disease.",,2020,,"['Metastatic Hormone-naïve Prostate Cancer', 'Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE']",['Radiotherapy'],[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0310658,,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Nunno', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Santoni', 'Affiliation': 'Oncology Unit, Macerata Hospital, Macerata, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gatto', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2019.02.005'] 3197,20127870,Event-related potential and functional MRI measures of face-selectivity are highly correlated: a simultaneous ERP-fMRI investigation.,"A face-selective neural signal is reliably found in humans with functional MRI and event-related potential (ERP) measures, which provide complementary information about the spatial and temporal properties of the neural response. However, because most neuroimaging studies so far have studied ERP and fMRI face-selective markers separately, the relationship between them is still unknown. Here we simultaneously recorded fMRI and ERP responses to faces and chairs to examine the correlations across subjects between the magnitudes of fMRI and ERP face-selectivity measures. Findings show that the face-selective responses in the temporal lobe (i.e., fusiform gyrus--FFA) and superior temporal sulcus (fSTS), but not the face-selective response in the occipital cortex (OFA), were highly correlated with the face-selective N170 component. In contrast, the OFA was correlated with earlier ERPs at about 110 ms after stimulus-onset. Importantly, these correlations reveal a temporal dissociation between the face-selective area in the occipital lobe and face-selective areas in the temporal lobe. Despite the very different time-scale of the fMRI and EEG signals, our data show that a correlation analysis across subjects may be informative with respect to the latency in which different brain regions process information.",2010,"A face-selective neural signal is reliably found in humans with functional MRI and event-related potential (ERP) measures, which provide complementary information about the spatial and temporal properties of the neural response.",[],[],"['fMRI and ERP responses', 'OFA']",[],[],"[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}]",,0.0161744,"A face-selective neural signal is reliably found in humans with functional MRI and event-related potential (ERP) measures, which provide complementary information about the spatial and temporal properties of the neural response.","[{'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Sadeh', 'Affiliation': 'Department of Psychology, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Podlipsky', 'Affiliation': ''}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Zhdanov', 'Affiliation': ''}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Yovel', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.20952'] 3198,31054784,"Re: Jürgen E. Gschwend, Matthias M. Heck, Jan Lehmann, et al. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol 2019;75:604-11.",,2019,,['Bladder Cancer Patients'],['Radical Cystectomy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]",[],,0.0645359,,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Taguchi', 'Affiliation': 'Department of Urology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Urology, Teikyo University School of Medicine, Tokyo, Japan. Electronic address: tohru-tky@umin.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Urology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}]",European urology,['10.1016/j.eururo.2019.04.031'] 3199,30988478,A values-alignment intervention protects adolescents from the effects of food marketing.,"Adolescents are exposed to extensive marketing for junk food, which drives overconsumption by creating positive emotional associations with junk food 1-6 . Here we counter this influence with an intervention that frames manipulative food marketing as incompatible with important adolescent values, including social justice and autonomy from adult control. In a preregistered, longitudinal, randomized, controlled field experiment, we show that this framing intervention reduces boys' and girls' implicit positive associations with junk food marketing and substantially improves boys' daily dietary choices in the school cafeteria. Both of these effects were sustained for at least three months. These findings suggest that reframing unhealthy dietary choices as incompatible with important values could be a low-cost, scalable solution to producing lasting, internalized change in adolescents' dietary attitudes and choices.",2019,Both of these effects were sustained for at least three months.,[],[],[],[],[],[],,0.0598307,Both of these effects were sustained for at least three months.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA. christopher.bryan@chicagobooth.edu.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Cintia P', 'Initials': 'CP', 'LastName': 'Hinojosa', 'Affiliation': 'University of Chicago Booth School of Business, Chicago, IL, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0586-6'] 3200,7045365,Posture and lumbar puncture headache: a controlled trial in 50 patients.,"A prospective single blind trial in 50 patients was performed to investigate the effect of posture on post lumbar puncture headache (LPH). A difference between the frequency of headache at five hours between the two groups (prone for four hours, versus 30 degrees head down tilt for 30 minutes followed by supine posture for 3 1/2 hours) did not reach significance. These findings do not support the suggestion that a prone posture, by possibly reducing cerebrospinal fluid (CSF) leakage, significantly reduces the frequency of this common clinical problem. The value of bed rest after lumbar puncture remains equivocal. Other methods used for reducing LPH are reviewed.",1982,"A difference between the frequency of headache at five hours between the two groups (prone for four hours, versus 30 degrees head down tilt for 30 minutes followed by supine posture for 3 1/2 hours) did not reach significance.",['50 patients'],[],"['frequency of headache', 'Posture and lumbar puncture headache', 'lumbar puncture headache (LPH', 'cerebrospinal fluid (CSF) leakage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0270697', 'cui_str': 'Post-Lumbar Puncture Headache'}, {'cui': 'C0023832', 'cui_str': 'beta-LPH'}, {'cui': 'C0023182', 'cui_str': 'Spinal Cerebrospinal Fluid Leak'}]",50.0,0.0492776,"A difference between the frequency of headache at five hours between the two groups (prone for four hours, versus 30 degrees head down tilt for 30 minutes followed by supine posture for 3 1/2 hours) did not reach significance.","[{'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Handler', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Perkin', 'Affiliation': ''}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Rose', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3201,9155774,Randomized trial of homeopathic arnica.,,1997,,[],['homeopathic arnica'],[],[],"[{'cui': 'C0555881', 'cui_str': 'Arnica extract'}]",[],,0.113974,,"[{'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Youngson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3202,31280725,Invited commentary in response to: Vitamin D 3 supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women.,,2019,,['iron-deficient women'],['Vitamin D3 supplementation'],['haematological status'],"[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.508424,,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Blanco-Rojo', 'Affiliation': 'Research Department, Biosearch Life, Granada, Spain.'}]",The British journal of nutrition,['10.1017/S0007114519001569'] 3203,31335603,CORR Insights®: Perineal Pressure During Hip Arthroscopy Is Reduced by Use of Trendelenburg: A Prospective Study With Randomized Order of Positioning.,,2019,,[],"['Trendelenburg', 'CORR Insights®: Perineal Pressure', 'Hip Arthroscopy']",[],[],"[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}]",[],,0.0267359,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Leunig', 'Affiliation': 'M. Leunig, Schulthess Clinic, Department of Orthopaedic Surgery, Zürich, Switzerland.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000879'] 3204,31498693,"Letter by Delmas et al Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0827502,,"[{'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Delmas', 'Affiliation': 'Intensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France (C.D.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Aix-Marseille University, APHM, Mediterranean Association for Research and Studies in Cardiology, Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Hopital Nord, Cardiology Department, Marseille, France (M.L., L.B.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bonello', 'Affiliation': 'Aix-Marseille University, APHM, Mediterranean Association for Research and Studies in Cardiology, Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Hopital Nord, Cardiology Department, Marseille, France (M.L., L.B.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041272'] 3205,31934790,"Need for Cognition, Transportability, and Engagement with Interactive Narratives.","Objective: Games for heath can take the form of interactive narratives, or stories in which readers have the option to make decisions about the direction of the plot. Individual differences may affect the extent to which individuals become engaged in such narratives. Materials and Methods: In two studies, we randomly assigned participants to read either a traditional linear narrative or an interactive version of the same narrative. We examined the influence of need for cognition (NFC) and transportability (the extent to which individuals tend to become immersed in narratives) on transportation, character identification, and perceived realism. Results: Transportability led to higher perceptions of realism in the interactive narrative in Study 1, but this effect was not replicated in Study 2. In Study 1, higher NFC led to greater identification in the interactive narrative; in Study 2, higher NFC led to greater transportation into the interactive narrative. Conclusion: Greater willingness to exert mental effort may lead to greater immersion in interactive narratives.",2020,"Transportability led to higher perceptions of realism in the interactive narrative in Study 1, but this effect was not replicated in Study 2.",[],['traditional linear narrative or an interactive version of the same narrative'],[],[],"[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]",[],,0.0377808,"Transportability led to higher perceptions of realism in the interactive narrative in Study 1, but this effect was not replicated in Study 2.","[{'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Green', 'Affiliation': 'Department of Communication, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Keenan M', 'Initials': 'KM', 'LastName': 'Jenkins', 'Affiliation': 'Department of Psychology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",Games for health journal,['10.1089/g4h.2019.0095'] 3206,31714314,"Response to the Comment on ""Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension: A Randomized Trial"".",,2020,,['Liver-Transplant Recipients With Severe Portal Hypertension'],['Somatostatin'],[],"[{'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}]","[{'cui': 'C0037659', 'cui_str': 'Somatostatin'}]",[],,0.0248305,,"[{'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Department of Clinical Medicine and Surgery Federico II University, Naples, Italy Department of Hepatobiliary and Liver Transplantation Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia Department of Clinical Medicine and Surgery Federico II University, Naples, Italy Department of Hepatobiliary and Liver Transplantation Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Roberto Ivan', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003675'] 3207,31884870,Effect of a feedback system on the quality of 2-minute chest compression-only cardiopulmonary resuscitation: a randomised crossover simulation study.,"OBJECTIVE We evaluated the quality of 2-minute continuous chest compressions (CCCs) performed by emergency staff in 30-second intervals to determine the effect of a feedback system on maintaining the quality of CCCs. METHODS Two hundred three physicians and nurses were randomised into two groups. Each participant performed 2-minute CCCs both with and without feedback. Group A performed CCCs under the guidance of a feedback device followed by performance without feedback, and Group B performed these tasks in reverse order. The primary outcome was the proportion of optimal compressions; i.e., compressions at both the correct rate (100-120 beats/minute) and correct depth (5-6 cm). RESULTS During 2-minute CCCs, the proportion of optimal compressions was poor in personnel without feedback. The proportion of optimal compressions was unchanged and low from 2.4% (interquartile range, 0.0%-32.8%) in the first 30 seconds to 3.3% (0.0%-47.7%) in the last 30 seconds of the 2-minute period. Use of the feedback device significantly improved and maintained the quality of compressions from the first 30 seconds (53.3%; 29.2%-70.4%) to the last 30 seconds (82.8%; 50.8%-96.2%). CONCLUSION Use of the feedback device was helpful for maintaining the quality of CCCs.",2019,,[],"['2-minute chest compression-only cardiopulmonary resuscitation', 'feedback system']",[],[],"[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0145469,,"[{'ForeName': 'Chunshuang', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shaoyun', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Ying', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuzhi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yulin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Anyu', 'Initials': 'A', 'LastName': 'Qian', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Guangju', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Emergency Medicine, Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University, Hangzhou, China.'}]",The Journal of international medical research,['10.1177/0300060519894440'] 3208,31808268,Modulation of simultaneously collected hemodynamic and electrophysiological functional connectivity by ketamine and midazolam.,"The pharmacological modulation of functional connectivity in the brain may underlie therapeutic efficacy for several neurological and psychiatric disorders. Functional magnetic resonance imaging (fMRI) provides a noninvasive method of assessing this modulation, however, the indirect nature of the blood-oxygen level dependent signal restricts the discrimination of neural from physiological contributions. Here we followed two approaches to assess the validity of fMRI functional connectivity in developing drug biomarkers, using simultaneous electroencephalography (EEG)/fMRI in a placebo-controlled, three-way crossover design with ketamine and midazolam. First, we compared seven different preprocessing pipelines to determine their impact on the connectivity of common resting-state networks. Independent components analysis (ICA)-denoising resulted in stronger reductions in connectivity after ketamine, and weaker increases after midazolam, than pipelines employing physiological noise modelling or averaged signals from cerebrospinal fluid or white matter. This suggests that pipeline decisions should reflect a drug's unique noise structure, and if this is unknown then accepting possible signal loss when choosing extensive ICA denoising pipelines could engender more confidence in the remaining results. We then compared the temporal correlation structure of fMRI to that derived from two connectivity metrics of EEG, which provides a direct measure of neural activity. While electrophysiological estimates based on the power envelope were more closely aligned to BOLD signal connectivity than those based on phase consistency, no significant relationship between the change in electrophysiological and hemodynamic correlation structures was found, implying caution should be used when making cross-modal comparisons of pharmacologically-modulated functional connectivity.",2020,"While electrophysiological estimates based on the power envelope were more closely aligned to BOLD signal connectivity than those based on phase consistency, no significant relationship between the change in electrophysiological and hemodynamic correlation structures was found, implying caution should be used when making cross-modal comparisons of pharmacologically-modulated functional connectivity.",[],"['electroencephalography', 'Functional magnetic resonance imaging (fMRI', 'midazolam', 'ketamine and midazolam']",[],[],"[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]",[],,0.0926645,"While electrophysiological estimates based on the power envelope were more closely aligned to BOLD signal connectivity than those based on phase consistency, no significant relationship between the change in electrophysiological and hemodynamic correlation structures was found, implying caution should be used when making cross-modal comparisons of pharmacologically-modulated functional connectivity.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsyth', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maxwell', 'Affiliation': 'Department of Anaesthesiology, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Sleigh', 'Affiliation': 'Department of Anaesthesiology Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'Institute of Neuroscience and Medicine, Brain & Behaviour (INM-7), Research Centre Jülich, Jülich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hipp', 'Affiliation': 'Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",Human brain mapping,['10.1002/hbm.24889'] 3209,31502945,User Experience Affects Dropout from Internet-Delivered Dialectical Behavior Therapy.,"Background: The emergence of computerized treatment may help reduce the gap between mental health treatment needs and accessibility, but unfortunately, dropout from these interventions is often high. Introduction: To increase the effectiveness of computerized interventions and reduce dropout, particularly among high-risk and clinically complex populations, better understanding of how usable and acceptable (i.e., user experience) these interventions are, informed by human computer interaction research, is needed. This study examines user experience of internet-delivered dialectical behavior therapy (iDBT). The major aim is to explore whether treatment dropout was affected by the complexity of population and/or user experience. Methods: Secondary analyses were conducted using data from a randomized controlled trial that evaluated iDBT in a sample of 59 suicidal and heavy episodic drinkers. Multivariate logistic regression and chi-square tests were performed to examine the roles of clinical characteristics and user experience in differentiating dropouts and nondropouts. Results: The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping. No clinical characteristics emerged as significant predictors of dropout. Discussion: The current results highlight technological problems as a possible barrier to adherence to computerized interventions. Future research would profit from increased integration of human-computer interaction to identify and solve user experience problems.",2020,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.",['59 suicidal and heavy episodic drinkers'],"['iDBT', 'internet-delivered dialectical behavior therapy (iDBT']",[],"[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]",[],59.0,0.0343292,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.","[{'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Psychology, Eastern Michigan University, Ypsilanti, Michigan, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0124'] 3210,31688273,"Comment on ""Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension-A Randomized Trial"".",,2020,,['liver-transplant recipients with severe portal hypertension'],['Somatostatin'],[],"[{'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}]","[{'cui': 'C0037659', 'cui_str': 'Somatostatin'}]",[],,0.0303483,,"[{'ForeName': 'Abdul R', 'Initials': 'AR', 'LastName': 'Hakeem', 'Affiliation': 'Institute of Liver Disease and Transplantation, Dr. Rela Institute & Medical Centre, Chromepet, Chennai, India. Institute of Liver Disease and Transplantation, Dr. Rela Institute & Medical Centre, Chromepet, Chennai, India. Institute of Liver Disease and Transplantation, Dr. Rela Institute & Medical Centre, Chromepet, Chennai, India. Institute of Liver Disease and Transplantation, Dr. Rela Institute & Medical Centre, Chromepet, Chennai, India.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Rammohan', 'Affiliation': ''}, {'ForeName': 'Mettu S', 'Initials': 'MS', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rela', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003680'] 3211,31694484,"Speech perception, real-ear measurements and self-perceived hearing impairment after remote and face-to-face programming of hearing aids: A randomized single-blind agreement study.","INTRODUCTION Current literature does not provide strong evidence that remote programming of hearing aids is effective, despite its increasing use by audiologists. We tested speech perception outcomes, real-ear insertion gain, and changes in self-perceived hearing impairment after face-to-face and remote programming of hearing aids in a randomized multicentre, single-blind crossover study. METHODS Adult experienced hearing aid users were enrolled during routine follow-up visits to audiology clinics. Hearing aids were programmed both face to face and remotely, then participants randomly received either the face-to-face or remote settings in a blinded manner and were evaluated 5 weeks later. Participants then received the other settings and were evaluated 5 weeks later. RESULTS Data from 52 out of 60 participants were analysed. We found excellent concordance in performance of hearing aids programmed face to face and remotely for speech understanding in quiet (phonetically balanced kindergarten test - intraclass correlation coefficient of 0.92 (95% confidence interval: 0.87-0.95)), and good concordance in performance for speech understanding in noise (phonetically balanced kindergarten +5 dB signal-to-noise ratio - intraclass correlation coefficient of 0.71 (95% confidence interval: 0.55-0.82)). Face-to-face and remote programming took 10 minutes (±2.9) and 10 minutes (±2.8), respectively. Real-ear insertion gains were highly correlated for input sound at 50, 65 and 80 dB sound pressure levels. The programming type did not affect the abbreviated profile of hearing aid questionnaire scores. CONCLUSIONS In experienced hearing aid users, face-to-face and remote programming of hearing aids give similar results in terms of speech perception, with no increase in the time spent on patients' care and no difference in self-reported hearing benefit. CLINICALTRIALS.GOV IDENTIFIER NCT02589561.",2019,,['hearing aids'],[],"['Speech perception, real-ear measurements and self-perceived hearing impairment']",[],[],"[{'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.0178994,,"[{'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Venail', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Picot', 'Affiliation': 'Biostatistics & Clinical Research Unit, University Montpellier, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Marin', 'Affiliation': 'Biostatistics & Clinical Research Unit, University Montpellier, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Falinower', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Samson', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Cizeron', 'Affiliation': 'AudioProConnect Company, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Balcon', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Blanc', 'Affiliation': 'Audition Conseil, Nîmes, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bricaud', 'Affiliation': 'Audition Conseil, Perpignan, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lorenzi', 'Affiliation': 'ENT and Audiology Department, University Hospital Gui de Chauliac, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Ceccato', 'Affiliation': 'Auditory Disorders, Institute for Neurosciences of Montpellier, INSERM, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Puel', 'Affiliation': 'Auditory Disorders, Institute for Neurosciences of Montpellier, INSERM, France.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19883543'] 3212,31710522,Aerobic Exercise Induces Cardiac Fat Loss and Alters Cardiac Muscle Mass Through an Interleukin-6 Receptor-Dependent Mechanism: Cardiac Analysis of a Double-Blind Randomized Controlled Clinical Trial in Abdominally Obese Humans.,,2019,,['Abdominally Obese Humans'],['Aerobic Exercise'],['Cardiac Fat Loss and Alters Cardiac Muscle Mass'],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.677863,,"[{'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Denmark (R.H.C., L.L.L., A.-S.W.-N., G.E.L., M.R.-L., K.K., R.K.-M., B.K.P., H.E.).'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Denmark (J.B.R.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.042287'] 3213,31889507,Prevalence of Group A Streptococcus in Primary Care Patients and the Utility of C-Reactive Protein and Clinical Scores for Its Identification in Thailand.,"Pharyngitis is usually caused by a viral infection for which antibiotics are often unnecessarily prescribed, adding to the burden of antimicrobial resistance. Identifying who needs antibiotics is challenging; microbiological confirmation and clinical scores are used but have limitations. In a cross-sectional study nested within a randomized controlled trial, we estimated the prevalence and antibiotic susceptibility profiles of group A Streptococcus (GAS) in patients presenting to primary care with a sore throat and fever in northern Thailand. We then evaluated the use of C-reactive protein (CRP) and clinical scores (Centor and FeverPAIN) to identify the presence of GAS. One hundred sixty-nine patients were enrolled, of whom 35 (20.7%) had β-hemolytic Streptococci (BHS) isolated from throat swab culture, and 11 (6.5%) had GAS. All GAS isolates were sensitive to penicillin G. The median CRP of those without BHS isolation was 10 mg/L (interquartile range [IQR] ≤ 8-18), compared with 18 mg/L (IQR 9-71, P = 0.0302) for those with GAS and 14 mg/L (IQR ≤ 8-38, P = 0.0516) for those with any BHS isolated. However, there were no significant relationships between CRP > 8 mg/L ( P = 0.112), Centor ≥ 3 ( P = 0.212), and FeverPAIN ≥ 4 ( P = 1.000), and the diagnosis of GAS compared with no BHS isolation. Identifying who requires antibiotics for pharyngitis remains challenging and necessitates further larger studies. C-reactive protein testing alone, although imperfect, can reduce prescribing compared with routine care. Targeted CRP testing through clinical scoring may be the most cost-effective approach to ruling out GAS infection.",2020,"However, there were no significant relationships between CRP > 8 mg/L ( P = 0.112), Centor ≥ 3 (","['Primary Care Patients with a Sore Throat and Fever in Thailand and the Utility of C-Reactive Protein and Clinical Scores for Its Identification', 'patients presenting to primary care with a sore throat and fever in Northern Thailand', 'One hundred sixty-nine patients were enrolled, of whom 35 (20.7%) had β-hemolytic Streptococci (BHS) isolated from throat swab culture, and 11 (6.5%) had GAS']","['penicillin G', 'antibiotic susceptibility profiles of group A Streptococcus (GAS']","['C-reactive protein (CRP) and clinical scores (Centor and FeverPAIN', 'median CRP']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0312853', 'cui_str': 'Hemolytic (qualifier value)'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0439056', 'cui_str': 'Throat swab (specimen)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0030827', 'cui_str': 'benzylpenicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0038411', 'cui_str': 'Streptococcus pyogenes'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",169.0,,"However, there were no significant relationships between CRP > 8 mg/L ( P = 0.112), Centor ≥ 3 (","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Greer', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.'}, {'ForeName': 'Daranee', 'Initials': 'D', 'LastName': 'Intralawan', 'Affiliation': 'Social and Preventive Medicine Department, Chiang Rai Regional Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Supalert', 'Initials': 'S', 'LastName': 'Nedsuwan', 'Affiliation': 'Social and Preventive Medicine Department, Chiang Rai Regional Hospital, Chiang Rai, Thailand.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Day', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0502'] 3214,31530065,Cost-effectiveness of telerehabilitation versus traditional care after total hip replacement: A trial-based economic evaluation.,"INTRODUCTION Physical rehabilitation for total hip replacement patients following hospital discharge is beneficial; however, accessing rehabilitation is often challenging. Telerehabilitation helps negate access issues and is efficacious in total knee and hip replacement patients. This study aims to compare the cost-effectiveness of a telerehabilitation programme delivered remotely into patients' homes versus traditional care for total hip replacement patients following hospital discharge. METHODS A cost-effectiveness (cost-utility) analysis was conducted from the perspective of a health service alongside a two-arm randomised controlled trial comparing telerehabilitation ( n =35) with in-person care ( n =35) following hospital discharge after total hip replacement. The primary analysis used an Incremental Cost-Effectiveness Ratio to compare the cost per Quality Adjusted Life Year (QALY) accrued in the telerehabilitation group versus in-person control using costs and effects data from the randomised trial. A secondary analysis was conducted whereby the time accrued by patients attending rehabilitation sessions (including travel time) was considered the ""cost"" (i.e. a time burden), rather than cost from the health service perspective. RESULTS Estimated mean differences in healthcare costs and QALYs gained were detected but were not significant. The estimated mean (95%CI) difference in cost of telerehabilitation versus in-person was -$28.90 (-$96.37 to $40.45), favouring the telerehabilitation group. The estimated mean (95%CI) difference in QALYs gained from telerehabilitation versus in-person was -0.0025 (-0.0227 to 0.0217). The estimated mean (95%CI) difference in time burden favoured less time burden for the telerehabilitation group (-4.21 (-4.69 to -3.74) hours). DISCUSSION Telerehabilitation in the total hip replacement population incurred similar costs and yielded similar effects to traditional in-person care. Telerehabilitation significantly reduced the time burden for patients and carers. These findings are valuable for healthcare providers seeking to implement accessible patient-centred rehabilitation services.",2019,,[],['telerehabilitation versus traditional care after total hip replacement'],[],[],"[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}]",[],,0.0178466,,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'QEII Jubilee Hospital, Metro South Hospital and Health Service, Brisbane, Australia.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Russell', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, College of Science, Health and Engineering, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bourke', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Queensland University of Technology, Institute of Health and Biomedical Innovation and School of Public Health & Social Work, Brisbane, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19869796'] 3215,31565784,A Picture is Worth a Thousand Words: The Role of Survey Training Materials in Stated-Preference Studies.,"BACKGROUND Online survey-based methods are increasingly used to elicit preferences for healthcare. This digitization creates an opportunity for interactive survey elements, potentially improving respondents' understanding and/or engagement. OBJECTIVE Our objective was to understand whether, and how, training materials in a survey influenced stated preferences. METHODS An online discrete-choice experiment (DCE) was designed to elicit public preferences for a new targeted approach to prescribing biologics (""biologic calculator"") for rheumatoid arthritis (RA) compared with conventional prescribing. The DCE presented three alternatives, two biologic calculators and a conventional approach (opt out), described by five attributes: delay to treatment, positive predictive value, negative predictive value, infection risk, and cost saving to the national health service. Respondents were randomized to receive training materials as plain text or an animated storyline. Training materials contained information about RA and approaches to treatment and described the biologic calculator. Background questions included sociodemographics and self-reported measures of task difficulty and attribute non-attendance. DCE data were analyzed using conditional and heteroskedastic conditional logit (HCL) models. RESULTS In total, 300 respondents completed the DCE, receiving either plain text (n = 158) or the animated storyline (n = 142). The HCL showed the estimated coefficients for all attributes aligned with a priori expectations and were statistically significant. The scale term was statistically significant, indicating that respondents who received plain-text materials had more random choices. Further tests suggested preference homogeneity after accounting for differences in scale. CONCLUSIONS Using animated training materials did not change the preferences of respondents, but they appeared to improve choice consistency, potentially allowing researchers to include more complex designs with increased numbers of attributes, levels, alternatives or choice sets.",2020,"Using animated training materials did not change the preferences of respondents, but they appeared to improve choice consistency, potentially allowing researchers to include more complex designs with increased numbers of attributes, levels, alternatives or choice sets.",[],"['plain text', 'training materials as plain text or an animated storyline', 'animated storyline']",['sociodemographics and self-reported measures of task difficulty and attribute non-attendance'],[],"[{'cui': 'C3543426', 'cui_str': 'Plain text (foundation metadata concept)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}]",300.0,0.0303792,"Using animated training materials did not change the preferences of respondents, but they appeared to improve choice consistency, potentially allowing researchers to include more complex designs with increased numbers of attributes, levels, alternatives or choice sets.","[{'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Vass', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Niall J', 'Initials': 'NJ', 'LastName': 'Davison', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Vander Stichele', 'Affiliation': 'MindBytes, Ghent, Belgium.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK. Katherine.payne@manchester.ac.uk.'}]",The patient,['10.1007/s40271-019-00391-w'] 3216,31498695,"Letter by O'Neill and Ohman Regarding Article, ""Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock: Matched-Pair IABP-SHOCK II Trial 30-Day Mortality Analysis"".",,2019,,['Acute Myocardial Infarction Complicated by Cardiogenic Shock'],[],[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}]",[],[],,0.0847539,,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': ""O'Neill"", 'Affiliation': ""Center for Structural Heart Disease, Henry Ford Hospital, Detroit, MI (W.W.O'N.).""}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Department of Medicine - Development and Innovation, Duke Heart Center, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (E.M.O.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.040831'] 3217,31956915,High water vs. ad libitum water intake for autosomal dominant polycystic kidney disease: a randomized controlled feasibility trial.,,2020,,['autosomal dominant polycystic kidney disease'],['High water vs. ad libitum water intake'],[],"[{'cui': 'C0085413', 'cui_str': 'ADPKD'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0013123', 'cui_str': 'Water Intake'}]",[],,0.0888021,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'El-Damanawi', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'PKD Charity, 91 Royal College, London.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Cowley', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pavey', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Sandford', 'Affiliation': 'Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Karet Frankl', 'Affiliation': 'Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Hiemstra', 'Affiliation': 'Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.'}]",QJM : monthly journal of the Association of Physicians,['10.1093/qjmed/hcz326'] 3218,32113628,Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation.,"OBJECTIVES There are no approved vaccines for respiratory syncytial virus (RSV), and consensus on methods to assess RSV vaccine efficacy has not been established. In this study of an adjuvanted RSV vaccine, we evaluated an RSV disease endpoint using a patient-reported outcome instrument (the inFLUenza Patient-Reported Outcome instrument [FLU-PRO]) and molecular testing for virologic confirmation. METHODS In a randomized, blinded efficacy study (NCT02508194), 1900 adult participants aged ≥60 years who had any respiratory symptom lasting ≥24 hours recorded symptoms in a FLU-PRO-based workbook for 21 days, self-collected nasal swabs on illness days 2 to 4, and had a site-collected swab obtained on (approximately) day 4. The endpoint, acute RSV-associated respiratory illness (ARA-RI), required specific symptoms with virologic confirmation. RESULTS The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial. The ARA-RI endpoint definition captured all 33 virologically confirmed RSV illnesses for which symptom data were provided, and in 32 of these, at least 1 lower respiratory symptom was reported. Sensitivity analysis with an endpoint requiring ≥2 lower respiratory symptoms captured greater symptom severity but fewer cases. Results of self- and site-collected swabs were highly correlated. Self-swabbing detected 9 additional cases that would have been missed by site swabbing only. CONCLUSIONS These results demonstrated the reliability and validity of the ARA-RI definition and of the FLU-PRO for use in RSV studies. Self-swabbing improved RSV detection.",2020,"The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial.","['Older Adults', '1900 adult participants aged ≥60 years who had any respiratory symptom lasting ≥24 hours recorded symptoms in a FLU-PRO-based workbook for 21 days, self-collected nasal swabs on illness days 2 to 4, and had a site-collected swab obtained on (approximately) day 4']","['adjuvanted RSV vaccine', 'Respiratory Syncytial Virus Vaccine']","['acute RSV-associated respiratory illness (ARA-RI), required specific symptoms with virologic confirmation', 'RSV vaccine efficacy', 'Self-swabbing improved RSV detection']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0242806', 'cui_str': 'Sick Days'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}]","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}]",1900.0,0.09763,"The FLU-PRO demonstrated reliability, ability to detect change, and validity and had high participant adherence and acceptable patient burden in the setting of an RSV prevention trial.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Clinical Biostatistics, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, George Washington University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vallo', 'Affiliation': 'Clinical Development, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Falloon', 'Affiliation': 'Clinical Development, Infectious Diseases and Vaccines, AstraZeneca, Gaithersburg, MD, USA. Electronic address: FalloonJ@VielaBio.com.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2019.09.2747'] 3219,731643,Multi-hospital trial on the use of ultraclean air systems in orthopaedic operating rooms to reduce infection: preliminary communication.,,1978,,[],[],[],[],[],[],,0.0280046,,"[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lowbury', 'Affiliation': ''}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Lidwell', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3220,32186454,"Re: Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study.",,2020,,['Patients with Erectile Dysfunction'],['Re: Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]",[],,0.308369,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000000991.03'] 3221,32186456,Re: Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,,2020,,['Overactive Bladder Symptoms in Men'],['Combined Behavioral and Drug Therapy'],[],"[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.16352,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001003.01'] 3222,32228328,Not All Green Is Tophi: The Importance of Optimizing Minimum Attenuation and Using a Tin Filter to Minimize Clumpy Artifacts on Foot and Ankle Dual-Energy CT.,"OBJECTIVE. The clumpy artifact has a high misdiagnosis rate, but the artifact has not been well studied. The aims of this study were to evaluate the frequency and location of clumpy artifacts, the rate of misdiagnosis of clumpy artifacts as gout, and the effects of raising the minimum attenuation value and using a selective photon shield in dual-energy CT (DECT). MATERIALS AND METHODS. Forty patients without gout who underwent foot and ankle DECT were enrolled in this study. Images in both sets were randomly assigned a minimum attenuation of 130 HU or 150 HU. Three radiologists independently checked all images for presence, volume, and location of green color-coded pixelation and graded their findings according to a 4-point confidence scale, frequency, and volume. Misdiagnosis rate and misdiagnosis score were compared using the Wilcoxon signed rank and McNemar tests. RESULTS. In set 1, the frequency of clumpy artifacts in DECT with the minimum attenuation set to 130 HU and 150 HU were 81% and 68%, respectively. For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU. In set 2, with the minimum attenuation set to 130 HU, the frequency of the clumpy artifact was 44%; with the minimum attenuation set to 150 HU, no clumpy artifacts were seen. CONCLUSION. Clumpy artifacts occurred frequently in DECT without a tin filter. Setting the minimum attenuation to the higher value of 150 HU reduced the frequency of clumpy artifacts, and adding a tin filter to DECT greatly reduced their occurrence.",2020,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.",['Forty patients without gout who underwent foot and ankle DECT'],['DECT'],"['Misdiagnosis rate and misdiagnosis score', 'misdiagnosis rate and misdiagnosis score', 'Clumpy artifacts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",[],"[{'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}]",40.0,0.0186423,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.","[{'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Yoo', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'You Seon', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Pusan National University Hospital, Biomedical Research Institute, Pusan, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Byon', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Jongjun', 'Initials': 'J', 'LastName': 'Pak', 'Affiliation': 'Siemens Healthineers Ltd., Diagnostic Imaging Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yunjung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22222'] 3223,7745577,Psychological distress and sub fertility.,,1995,,[],[],['Psychological distress and sub fertility'],[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}]",,0.0211808,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hinton', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meadowcroft', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wardle', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3224,31404005,"Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial: The MIRO Trial.","BACKGROUND Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. OBJECTIVES The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. METHODS We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. RESULTS The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. CONCLUSIONS Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.",2020,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","['Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus', '13 study centers between 2009 and 2012', 'Patients With Esophageal Cancer']","['Minimally Invasive Versus Open Esophagectomy', 'open esophagectomy (OE', 'Hybrid minimally invasive esophagectomy (HMIE', 'transthoracic OE or HMIE', 'HMIE and OE']","['pain', 'Postoperative complications', 'Health-related Quality of Life', 'social functioning', 'short- and long-term health-related quality of life (HRQOL', 'global HRQOL', 'role functioning, pain, and dysphagia', 'role functioning [-33.33 (HMIE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4517717', 'cui_str': 'Thirty-three point three three'}]",13.0,0.257365,"At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303).","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Mariette', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': 'Sheraz', 'Initials': 'S', 'LastName': 'Markar', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tienhan Sandrine', 'Initials': 'TS', 'LastName': 'Dabakuyo-Yonli', 'Affiliation': 'Epidemiology and Quality of Life Unit, INSERM 1231 Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Hepatobiliary and Digestive Surgery, CHU of Rennes, University of Rennes 1, Rennes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'Department of Digestive and Hepatobiliary Surgery, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Collet', 'Affiliation': 'Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France.'}, {'ForeName': 'Xavier Benoit', 'Initials': 'XB', 'LastName': ""D'Journo"", 'Affiliation': 'Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Perniceni', 'Affiliation': 'Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Carrere', 'Affiliation': 'Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, CRCT UMR, Toulouse, France.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Mabrut', 'Affiliation': 'Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of Digestive and General Surgery, CHU Louis Mourier, AP-HP, Université Paris 7, Denis Diderot PRES Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Peschaud', 'Affiliation': 'Department of Surgery and Oncology, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Université de Versailles, Boulogne-Billancourt, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Digestive Surgery Department, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003559'] 3225,32048274,"DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial.","BACKGROUND Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the ""DEXamethasone twice for pain treatment after TKA"" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled. METHODS ""DEXamethasone twice for pain treatment after TKA"" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and 48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively. DISCUSSION The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen. TRIAL REGISTRATION EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).",2020,The primary outcome is total opioid consumption (intravenous morphine milligram equivalents) 0,"['twice for pain treatment after Total Knee Arthroplasty', 'postoperative pain treatment after total knee arthroplasty', ""twice for pain treatment after TKA' (DEX-2-TKA""]","['dexamethasone', 'paracetamol, ibuprofen, and local infiltration analgesia', 'intravenous 24 mg dexamethasone, or matching intravenous placebo', 'DEXamethasone', 'DEX-2-TKA - DEXamethasone', 'glucocorticoid']","['1) visual analogue scale pain levels: a) during active 45 degrees flexion of the knee at 24 and 48 hours postoperatively, b) at rest', 'proportion of participants with one or more adverse events', 'total opioid consumption (intravenous morphine milligram equivalents) 0']","[{'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'milligram'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",,0.433772,The primary outcome is total opioid consumption (intravenous morphine milligram equivalents) 0,"[{'ForeName': 'Kasper S', 'Initials': 'KS', 'LastName': 'Gasbjerg', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hägi-Pedersen', 'Affiliation': 'Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.'}, {'ForeName': 'Troels H', 'Initials': 'TH', 'LastName': 'Lunn', 'Affiliation': 'Department of Anaesthesiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Overgaard', 'Affiliation': 'Orthopedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Anker', 'Initials': 'NA', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesia, Gildhøj Private Hospital, Brøndby, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bagger', 'Affiliation': 'Department of Orthopaedics, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lindholm', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Brorson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kasper H', 'Initials': 'KH', 'LastName': 'Thybo', 'Affiliation': 'Department of Anaesthesiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Janus C', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13560'] 3226,31973839,"Re: Samuelson et al.: Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract: two-year results (Ophthalmology. 2019;126:811-821).",,2020,,['primary open-angle glaucoma and cataract'],['ab interno implanted trabecular micro-bypass'],[],"[{'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]",[],,0.0188452,,"[{'ForeName': 'Karina Carvalho', 'Initials': 'KC', 'LastName': 'Melo Araújo', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil.'}, {'ForeName': 'Elson Cabral', 'Initials': 'EC', 'LastName': 'Velanes Neto', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Bassoli Scoralick', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, Federal University of São Paulo, Brazil.'}, {'ForeName': 'Fabio Nishimura', 'Initials': 'FN', 'LastName': 'Kanadani', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, IOCM, Belo Horizonte, Brazil; Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Tiago Santos', 'Initials': 'TS', 'LastName': 'Prata', 'Affiliation': 'Glaucoma Service, Department of Ophthalmology, Federal University of São Paulo, Brazil; Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida. Electronic address: t.prata0807@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.042'] 3227,32058422,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': 'X-D Wu, D. Wu, Y. Liu, Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. W. Huang, Department of Orthopaedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001158'] 3228,21761505,Using spatial multiple regression to identify intrinsic connectivity networks involved in working memory performance.,"Many researchers have noted that the functional architecture of the human brain is relatively invariant during task performance and the resting state. Indeed, intrinsic connectivity networks (ICNs) revealed by resting-state functional connectivity analyses are spatially similar to regions activated during cognitive tasks. This suggests that patterns of task-related activation in individual subjects may result from the engagement of one or more of these ICNs; however, this has not been tested. We used a novel analysis, spatial multiple regression, to test whether the patterns of activation during an N-back working memory task could be well described by a linear combination of ICNs delineated using Independent Components Analysis at rest. We found that across subjects, the cingulo-opercular Set Maintenance ICN, as well as right and left Frontoparietal Control ICNs, were reliably activated during working memory, while Default Mode and Visual ICNs were reliably deactivated. Further, involvement of Set Maintenance, Frontoparietal Control, and Dorsal Attention ICNs was sensitive to varying working memory load. Finally, the degree of left Frontoparietal Control network activation predicted response speed, while activation in both left Frontoparietal Control and Dorsal Attention networks predicted task accuracy. These results suggest that a close relationship between resting-state networks and task-evoked activation is functionally relevant for behavior, and that spatial multiple regression analysis is a suitable method for revealing that relationship.",2012,"Finally, the degree of left Frontoparietal Control network activation predicted response speed, while activation in both left Frontoparietal Control and Dorsal Attention networks predicted task accuracy.",[],[],[],[],[],[],,0.0223334,"Finally, the degree of left Frontoparietal Control network activation predicted response speed, while activation in both left Frontoparietal Control and Dorsal Attention networks predicted task accuracy.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Gordon', 'Affiliation': 'Interdisciplinary Program in Neuroscience, Georgetown University Medical Center, Washington, District of Columbia, USA. emg56@georgetown.edu'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stollstorff', 'Affiliation': ''}, {'ForeName': 'Chandan J', 'Initials': 'CJ', 'LastName': 'Vaidya', 'Affiliation': ''}]",Human brain mapping,['10.1002/hbm.21306'] 3229,31564516,"The impact of intensified clinical care on glycaemic control in patients with type 2 diabetes at Khayelitsha Community Health Centre, South Africa: Quasi-experimental study.","AIM The aim was to evaluate the effect on glycaemic control of more intensive care for patients with very uncontrolled type-2 diabetes (HbA1c>10%) at Khayelitsha Community Health Centre, South Africa. METHODS A pragmatic, quasi-experimental study. Patients with HBA1c>10% were consecutively selected into a 6-month programme of intensified care involving monthly visits to a doctor, diabetes group education, escalation of treatment, and more frequent HbA1c testing by either point-of-care (POC) or laboratory. Participants were their own controls in a retrospective analysis of usual care during the previous year. RESULTS At baseline 236 patients had a mean HbA1c of 12.1%. The mean difference in HbA1c in the intervention group was -1.1% (p<0.001). The intervention group were exposed to group diabetes education (100% vs 0%), more visits (3.8 vs 3.2, p<0.001), more HbA1c tests (2.2 vs 0.9, p<0.001). There was no difference in increased dose of insulin between the groups or between POC and standard laboratory intervention sub-groups. CONCLUSION The introduction of group diabetes education was the most likely explanation for improved glycaemic control in this poor, under-resourced, public sector, peri-urban setting. The study demonstrates a feasible approach to improving diabetes care in the South African context.",2020,The mean difference in HbA1c in the intervention group was -1.1% (p<0.001).,"['patients with type 2 diabetes at Khayelitsha Community Health Centre, South Africa', 'Participants were their own controls in a retrospective analysis of usual care during the previous year', 'patients with very uncontrolled type-2 diabetes (HbA1c>10%) at Khayelitsha Community Health Centre, South Africa', 'Patients with HBA1c>10% were consecutively selected into a 6-month programme of intensified care involving monthly visits to a doctor, diabetes group education, escalation of treatment, and more frequent HbA1c testing by either point-of-care (POC) or laboratory']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],[],236.0,0.041459,The mean difference in HbA1c in the intervention group was -1.1% (p<0.001).,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Allerton', 'Affiliation': 'Division of Family Medicine and Primary Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Box 241, Cape Town, 8000, South Africa. Electronic address: joshallerton@gmail.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mash', 'Affiliation': 'Division of Family Medicine and Primary Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Box 241, Cape Town, 8000, South Africa. Electronic address: rm@sun.ac.za.'}]",Primary care diabetes,['10.1016/j.pcd.2019.08.006'] 3230,31973633,Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial.,"INTRODUCTION The low quality of life in heart failure patients is related to low self-care and treatment adherence. Consequently, innovative strategies are needed to improve them. The objective of this work is to determine the effectiveness of the use of a home telemonitoring system to improve the self-care and treatment adherence of heart failure patients. METHODS A randomized clinical trial that compares the efficacy of a home telemonitoring system -intervention group versus usual care control group - among heart failure outpatients over a 90-day monitoring period was carried out. The home telemonitoring system consists of an application that collects measurements of different parameters on a daily basis and provides health education to patients. The home telemonitoring system processes data gathered and generates an alert if a risky situation arises. The outcomes observed were significant changes in patients' self-care (European Heart Failure Self-care Behaviour Scale), treatment adherence (Morisky Modified Scale) and re-hospitalizations over the follow-up period. RESULTS 104 heart failure patients were screened; 40 met the inclusion criteria; only 30 completed the study. After the follow-up, intragroup analysis of the control group indicated a decrease in treatment adherence ( p  = 0.02). The mean European Heart Failure Self-care Behaviour Scale overall score indicated an improved self-care in the intervention group patients ( p  = 0.03) and a worsened self-care in the control group ( p  = 0.04) with a p value of 0.004 in the intergroup analysis. Thanks to the home telemonitoring system alerts, two re-hospitalizations were avoided. DISCUSSION This study demonstrated that the proposed home telemonitoring system improves patient self-care when compared to usual care and has the potential to avoid re-hospitalizations, even considering patients with low literacy levels. Trial Registration: Home Telemonitoring System for Patients with Heart Failure. clinicaltrials.gov Identifier: NCT04071093.",2020,,['heart failure patients'],[],[],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.115568,,"[{'ForeName': 'Lucía M', 'Initials': 'LM', 'LastName': 'Yanicelli', 'Affiliation': 'Instituto de Desarrollo y Diseño, CONICET & Universidad Tecnológica Nacional, Argentina.'}, {'ForeName': 'Carla B', 'Initials': 'CB', 'LastName': 'Goy', 'Affiliation': 'Laboratorio de Medios e Interfases, Universidad Nacional de Tucumán, Argentina.'}, {'ForeName': 'Viviana Del C', 'Initials': 'VDC', 'LastName': 'González', 'Affiliation': 'Hospital Centro de Salud Zenón J Santillán, Argentina.'}, {'ForeName': 'Gerardo N', 'Initials': 'GN', 'LastName': 'Palacios', 'Affiliation': 'Hospital Centro de Salud Zenón J Santillán, Argentina.'}, {'ForeName': 'Ernesto C', 'Initials': 'EC', 'LastName': 'Martínez', 'Affiliation': 'Instituto de Desarrollo y Diseño, CONICET & Universidad Tecnológica Nacional, Argentina.'}, {'ForeName': 'Myriam C', 'Initials': 'MC', 'LastName': 'Herrera', 'Affiliation': 'Laboratorio de Investigaciones Cardiovasculares Multidisciplinarias, Universidad Nacional de Tucumán, Argentina.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19899261'] 3231,633246,Assessment of clinical response to long-term domiciliary oxygen therapy in hypoxic patients with obstructive airway disease.,,1978,,['hypoxic patients with obstructive airway disease'],['long-term domiciliary oxygen therapy'],[],"[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0338047', 'cui_str': 'Domiciliary (environment)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]",[],,0.0221317,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Brennan', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Anderson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3232,10700854,Placebo and placebo effects in medicine.,,2000,,['medicine'],"['Placebo', 'placebo']",[],"[{'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.357296,,"[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Dean', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3233,399619,Insomnia and hypnotherapy.,,1979,,[],[],[],[],[],[],,0.0146026,,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Basker', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3234,399620,Inhalation sedation - an adjunct to improved dental care: preliminary communication.,,1979,,[],[],[],[],[],[],,0.0107333,,"[{'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Brook', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Major', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Winder', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3235,32250171,The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.,"BACKGROUND Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. AIM The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. METHODS This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. RESULTS We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. CONCLUSIONS We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.",2020,,[],[],[],[],[],[],,0.0302903,,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Trine L', 'Initials': 'TL', 'LastName': 'Wilkens', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Clement A', 'Initials': 'CA', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Joline Wj', 'Initials': 'JW', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Edenberg', 'Affiliation': 'Indiana University School of Medicine, USA.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Eriksen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Ilse C', 'Initials': 'IC', 'LastName': 'Schrieks', 'Affiliation': 'Department of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': ""Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.""}]",European journal of preventive cardiology,['10.1177/2047487320912376'] 3236,31586241,"Efficacy of non-steroidal anti-inflammatory drugs on zoledronic acid-induced acute-phase reactions: randomized, open-label, Japanese OZ study.","INTRODUCTION Zoledronic acid infusion is used to treat osteoporosis but patients, especially Japanese patients, often experience acute-phase reactions (APRs). In this multicenter, randomized, open-label, parallel-group study, we examined the efficacy of the most commonly used non-steroidal anti-inflammatory drug loxoprofen in Japan in reducing the incidence rate of zoledronic acid-induced APRs and body temperature, and investigated risk/protective factors for APRs in this population. MATERIALS AND METHODS Patients aged ≥ 60 years with primary osteoporosis (n = 368) were allocated randomly to zoledronic acid plus loxoprofen (ZOL + LOX) or zoledronic acid alone (ZOL). All patients received 5-mg zoledronic acid infusion on day 1, and patients in the ZOL + LOX group also received 120 mg and 180 mg of oral loxoprofen on days 1 and 2, respectively. Adverse events and body temperature were recorded during the 7-day observation period. RESULTS The incidence rates of APRs were 34.4% (64/186 patients) and 47.8% (87/182 patients) in the ZOL + LOX and ZOL groups, respectively (P = 0.0109). The proportions of patients with increased body temperature (≥ 1 °C and ≥ 37.5 °C) were similar in both groups (P = 0.1186). Past bisphosphonate users had a significantly lower incidence rate of APRs than treatment-naïve patients (odds ratio 0.444, 95% confidence interval 0.285-0.692, P = 0.0003). CONCLUSIONS Zoledronic acid-induced APRs appeared to be suppressed by loxoprofen. Known risk/protective factors, including prior osteoporosis treatment, were applicable to Japanese patients.",2020,"Past bisphosphonate users had a significantly lower incidence rate of APRs than treatment-naïve patients (odds ratio 0.444, 95% confidence interval 0.285-0.692, P = 0.0003). ","['60\xa0years with primary osteoporosis (n\u2009=\u2009368', '37.5', 'Patients aged\u2009≥', 'patients with increased body temperature (≥\u20091\xa0°C and\u2009≥', 'Japanese patients', 'osteoporosis but patients, especially Japanese patients, often experience acute-phase reactions (APRs']","['Zoledronic acid infusion', 'zoledronic acid plus loxoprofen (ZOL\u2009+\u2009LOX) or zoledronic acid alone (ZOL', 'Zoledronic acid', 'ZOL\u2009+\u2009LOX group also received 120\xa0mg and 180\xa0mg of oral loxoprofen', '5-mg zoledronic acid infusion', 'non-steroidal anti-inflammatory drugs']","['Adverse events and body temperature', 'incidence rate of APRs', 'incidence rates of APRs']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001349', 'cui_str': 'Response, Acute-Phase'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065199', 'cui_str': 'loxoprofen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",368.0,0.0258953,"Past bisphosphonate users had a significantly lower incidence rate of APRs than treatment-naïve patients (odds ratio 0.444, 95% confidence interval 0.285-0.692, P = 0.0003). ","[{'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Okimoto', 'Affiliation': 'Okimoto Clinic, 185-4 Kubi, Yutaka-machi, Kure, Hiroshima, 734-0304, Japan. noboki4@yahoo.co.jp.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Sakai', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, 807-8555, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Orthopedic Surgery, Shimura Hospital, 3-13 Funairimachi, Naka-ku, Hiroshima, 730-0841, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Orthopedic Surgery, Shimura Hospital, 3-13 Funairimachi, Naka-ku, Hiroshima, 730-0841, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Asano', 'Affiliation': 'Department of Orthopedic Surgery, Shimura Hospital, 3-13 Funairimachi, Naka-ku, Hiroshima, 730-0841, Japan.'}, {'ForeName': 'Shojiro', 'Initials': 'S', 'LastName': 'Akahoshi', 'Affiliation': 'Department of Orthopedic Surgery, Obase Hospital, 1598 Aratsu, Kandamachi, Miyako, Fukuoka, 800-0344, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishikura', 'Affiliation': 'Department of Orthopedic Surgery, Obase Hospital, 1598 Aratsu, Kandamachi, Miyako, Fukuoka, 800-0344, Japan.'}, {'ForeName': 'Shito', 'Initials': 'S', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Orthopedic Surgery, Obase Hospital, 1598 Aratsu, Kandamachi, Miyako, Fukuoka, 800-0344, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Fuse', 'Affiliation': 'Department of Orthopedic Surgery, Saka Midorii Hospital, 6-28-1 Midorii, Asaminami-ku, Hiroshima, 731-0103, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Department of Orthopedic Surgery, Shobara Red Cross Hospital, 2-7-10 Nishihonmachi, Shobara, Hiroshima, 727-0013, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Katae', 'Affiliation': 'Department of Orthopedic Surgery, Akaike Kyodo Clinic, 521Akaike, Fukuchimachi, Tagawa, Fukuoka, 822-1101, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Orthopedic Surgery, Sanzai Hospital, 3378 Shimosanzai, Saito, Miyazaki, 881-0113, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Orthopedic Surgery, Kaisei General Hospital, 3-5-28 Muromachi, Sakaide, Kagawa, 762-0007, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Nishida', 'Affiliation': 'Department of Orthopedic Surgery, Shin-Kokura Hospital, 1-3-1 Kanada, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8505, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Orthopedic Surgery, Ken-Ai Memorial Hospital, 1191 Kimori, Onga-cho, Onga, Fukuoka, 811-4313, Japan.'}, {'ForeName': 'Kunitaka', 'Initials': 'K', 'LastName': 'Menuki', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, 807-8555, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Saito', 'Affiliation': 'Department of Orthopedic Surgery, Shunankogen Hospital, 29-1 Susumahongo, Shunan, Yamaguchi, 745-0122, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Okazaki', 'Affiliation': 'Department of Orthopedic Surgery, Tobata General Hospital, 1-3-33 Fukuryugi, Tobata, Kitakyushu, Fukuoka, 804-0025, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Orthopedic Surgery, Saiseikai Kure Hospital, 2-1-13 Sanjyo, Kure, Hiroshima, 737-0821, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Fujiwara', 'Affiliation': ""Department of Pharmacy, Yasuda Women's University, 6-13-1 Yasuhigashi, Asaminami-ku, Hiroshima, 731-0153, Japan.""}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01050-8'] 3237,32065499,Development and randomised controlled trial of a Continence Product Patient Decision Aid for men postradical prostatectomy.,"AIMS AND OBJECTIVES To develop and evaluate an evidence-based Continence Product Patient Decision Aid (CP-PDA) to reduce decisional conflict and support continence product choice for men postradical prostatectomy. BACKGROUND In 2018, 1.3 million men globally were diagnosed with prostate cancer. A common treatment is radical prostatectomy, usually leading to sudden onset of urinary incontinence. For people experiencing incontinence, products to contain leakage are fundamental to health-related quality of life, but many product users and healthcare professionals are unaware of available options. No evidence-based guidance on choosing products exists despite known physical and psychological burdens of poorly managed leakage (e.g. isolation, anxiety, depression, skin damage). DESIGN AND METHODS 4 phases, underpinned by international decision aid guidance. Evidence/expert opinion: Literature review; consultation with specialist continence clinicians (n = 7) to establish evidence base. Prototype: CP-PDA developed with continence specialist (n = 7) feedback. Alpha testing (stakeholders): CP-PDA materials were provided to expert patients (n = 10) and clinicians (n = 11) to assess content/presentation. Beta testing (field) following CONSORT guidelines, registered NIHR CPMS 31077: Men (n = 50) postradical prostatectomy randomised to evaluate usability and decision-making using the Decisional Conflict Scale compared with usual care. RESULTS An algorithm differentiating patients by mobility, dependency, cognitive impairment and type/level of leakage, leading to 12 user groups, was developed. For each group, an option table and associated product information sheets guide product choice. Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without. CP-PDA users reported greater confidence in product knowledge and choice. CONCLUSION This is the first evidence-based CP-PDA, developed using an internationally recognised method. Compared to usual care, it significantly reduced decisional conflict for men choosing continence products postprostatectomy. RELEVANCE TO CLINICAL PRACTICE The CP-PDA provides nurses with the first comprehensive, evidence-based intervention to help postprostatectomy men in complex continence product choices. An online version is available: www.continenceproductadvisor.org.",2020,Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without.,"['In 2018, 1.3 million men globally were diagnosed with prostate cancer', '4 phases, underpinned by international decision-aid guidance', 'men post-radical prostatectomy']","['Alpha testing (stakeholders', 'evidence-based Continence Product Patient Decision Aid (CP- PDA', 'Continence Product Patient Decision Aid', 'CP-PDA', 'Prototype: CP-PDA']","['decisional conflict', 'Total Decisional Conflict Score']","[{'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",31077.0,0.0729149,Total Decisional Conflict Score for men using the CP-PDA was significantly better than for men without.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'de Laine', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macaulay', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Fader', 'Affiliation': 'School of Health Sciences, University of Southampton, Southampton, UK.'}]",Journal of clinical nursing,['10.1111/jocn.15223'] 3238,30278197,"Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360° Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial.","PURPOSE The effectiveness of selective laser trabeculoplasty (SLT) was compared with argon laser trabeculoplasty (ALT) in a randomized clinical trial for patients with medically uncontrolled open-angle glaucoma who have previously received 360° SLT. DESIGN An active equivalence parallel armed randomized control trial. PARTICIPANTS Patients with open-angle glaucoma including pigmentary dispersion syndrome and pseudoexfoliation syndrome were enrolled into the study from 7 different sites across Canada. METHODS One setting of 180° of either SLT or ALT was assigned randomly and applied to each participant. MAIN OUTCOME MEASURES The change in intraocular pressure (IOP) from baseline to 12 months was compared between the 2 groups. RESULTS A total of 132 patients were recruited, 2 of which dropped out early in the study, leaving 130 patients who completed the study as per protocol. For those, the study's primary outcome was calculated. The IOP change at 1 year in comparison to baseline for SLT vs. ALT was found to be different by 0.33 mmHg between the 2 groups (3.16 for SLT and 2.83 for ALT) and was not statistically significant (P = 0.71) Further analysis, though, showed that SLT had a significantly lower IOP reduction at early time points: 1 week and 1 month, but this effect was lost by 3 months. Corresponding to this finding was the strong trend for ALT to fail more quickly than SLT. Although repeatable, the first repeat SLT reduced IOP to only about half compared with initial SLT treatment. CONCLUSIONS The comparison at 12 months following the laser therapy showed that both modalities lowered the IOP with approximately 3 mmHg, yet essentially all of the time-to-failure analyses favored SLT over ALT. The repeat SLT effect was found to be half of the initial treatment.",2019,"Further analysis, though, showed that SLT had a significantly lower IOP reduction at early time points: 1 week and 1 month, but this effect was lost by 3 months.","['patients with medically uncontrolled open-angle glaucoma who have previously received 360° SLT', 'A total of 132 patients were recruited, 2 of which dropped out early in the study, leaving 130 patients who completed the study as per protocol', 'Glaucoma Patients Treated Previously with 360°', 'Patients with open-angle glaucoma including pigmentary dispersion syndrome and pseudoexfoliation syndrome were enrolled into the study from 7 different sites across Canada']","['Selective Laser Trabeculoplasty', 'Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty', 'selective laser trabeculoplasty (SLT', 'argon laser trabeculoplasty (ALT', 'SLT or ALT', 'SLT']","['repeat SLT effect', 'IOP change', 'IOP', 'IOP reduction', 'intraocular pressure (IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}, {'cui': 'C1319234', 'cui_str': 'Argon laser trabeculoplasty'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}]",132.0,0.113391,"Further analysis, though, showed that SLT had a significantly lower IOP reduction at early time points: 1 week and 1 month, but this effect was lost by 3 months.","[{'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hutnik', 'Affiliation': 'Department of Ophthalmology, Western University, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Crichton', 'Affiliation': 'Department of Ophthalmology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Ford', 'Affiliation': 'Department of Ophthalmology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Nicolela', 'Affiliation': 'Department of Ophthalmology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Lesya', 'Initials': 'L', 'LastName': 'Shuba', 'Affiliation': 'Department of Ophthalmology, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Birt', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Enitan', 'Initials': 'E', 'LastName': 'Sogbesan', 'Affiliation': 'Department of Ophthalmology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Karim F', 'Initials': 'KF', 'LastName': 'Damji', 'Affiliation': 'Department of Ophthalmology, University of Alberta, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dorey', 'Affiliation': 'Department of Ophthalmology, University of Alberta, Alberta, Canada.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'Saheb', 'Affiliation': 'Department of Ophthalmology, McGill University, Montreal, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Klar', 'Affiliation': 'Department of Ophthalmology, Western University, Ontario, Canada.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Ophthalmology, Western University, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hodge', 'Affiliation': 'Department of Ophthalmology, Western University, Ontario, Canada. Electronic address: William.Hodge@sjhc.london.on.ca.'}]",Ophthalmology,['10.1016/j.ophtha.2018.09.037'] 3239,32101864,"The Results Given in the Paper by Bruyère et al. ""Multicenter, Randomized, Placebo-Controlled Study [of] the Efficacy of a Combination of Propolis and Cranberry… (DUAB®) in Preventing Low Urinary Tract Infection Recurrence in Women… [with] Recurrent Cystitis"" Should Be Used with Great Caution.",,2020,,['Women'],"['Combination of Propolis and Cranberry… (DUAB®', 'Placebo']",['… [with] Recurrent Cystitis'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0936050', 'cui_str': 'Cranberry'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0581366', 'cui_str': 'Recurrent cystitis (disorder)'}]",,0.0523368,,"[{'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bruyère', 'Affiliation': 'Urologie, CHRU Tours, Tours, France, f.bruyere@chu-tours.fr.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rigaudier', 'Affiliation': 'CEN Biotech, Impasse Françoise Dolto, Dijon, France.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Sotto', 'Affiliation': 'Maladies Infectieuses et Tropicales, CHU Caremeau, Nîmes, France.'}]",Urologia internationalis,['10.1159/000506022'] 3240,6338230,Sleep and the enuresis alarm device.,"The effect on sleep of the wire-mesh element within the `buzzer and pad' enuresis alarm device was studied using healthy adult volunteers in a single or double crossover design. Polygraphic recording revealed a reduction in the number of shifts between sleep stages, and in the time spent in wakefulness, movement and stage 1, on the nights when the mesh was in the bed. This effect may be responsible for preventing some of the enuretic episodes which would otherwise have occurred at such times.",1983,"Polygraphic recording revealed a reduction in the number of shifts between sleep stages, and in the time spent in wakefulness, movement and stage 1, on the nights when the mesh was in the bed.",['healthy adult volunteers'],[],[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]",[],[],,0.0424636,"Polygraphic recording revealed a reduction in the number of shifts between sleep stages, and in the time spent in wakefulness, movement and stage 1, on the nights when the mesh was in the bed.","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Sireling', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Crisp', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3241,552547,Timing of tourniquet removal after knee replacement.,,1979,,[],[],[],[],[],[],,0.0266728,,"[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Waugh', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3242,7745581,Does altitude or exercise induce fibrin degradation in mountaineers?,,1995,,[],[],[],[],[],[],,0.0183338,,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roeggla', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roeggla', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Binder', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3243,32234610,"Examining the associations between alcohol-related parental communication, alcohol use, and protective behavioral strategy use among young adults.","Underage alcohol use is a public health concern as it remains prevalent and problematic. Protective behavioral strategies (PBS) may prevent or reduce alcohol-related consequences, yet daily-level findings show they instead might be associated with increased drinking and consequences. While parents are a possible source of influence to their child's decision making, it is unclear whether parental communication about alcohol affects drinking outcomes, with mixed findings noted in the literature. Furthermore, little research focuses on understanding how parental communication may impact the use of PBS. This study assessed whether alcohol specific parental communication would be associated with reduced drinking and increased use of PBS. Data from baseline and 3-month follow up were evaluated from a control group of a larger randomized controlled trial on 18- to 20-year-olds in the U.S. (N = 269). Outcomes included drinks per week, peak drinks per occasion, negative consequences and use of PBS. Using negative binomial regression modeling, controlling for age, sex, and whether participants lived with parents, findings revealed that parental communication was not associated with drinks per week, peak drinks per occasion, or negative consequences reported 3 months later. However, it was positively associated with limiting/stopping drinking PBS, manner of drinking PBS, and serious harm reduction PBS reported 3 months later. Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking. Research is needed to determine why parental communication may influence the use of PBS and how we can strengthen the quality or focus of communication to ultimately increase the impact on risk behaviors.",2020,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"['18- to 20-year-olds in the U.S', 'young adults']",['Protective behavioral strategies (PBS'],"['drinks per week, peak drinks per occasion, negative consequences and use of PBS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]",,0.0247036,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"[{'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Litt', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States. Electronic address: Dana.Litt@unthsc.edu.'}, {'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, Murray State University, Murray, KY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Lowery', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'LoParco', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Annalynn M', 'Initials': 'AM', 'LastName': 'Galvin', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Box 354944, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106398'] 3244,32265012,Surgical telemedicine here to stay: More support from a randomized controlled trial on postoperative surgery visits.,,2020,,[],[],[],[],[],[],,0.142445,,"[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Forbes', 'Affiliation': 'Vanderbilt University Medical Center, Department of General Surgery, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA. Electronic address: rachel.forbes@vumc.org.'}, {'ForeName': 'Carmen C', 'Initials': 'CC', 'LastName': 'Solorzano', 'Affiliation': 'Vanderbilt University Medical Center, Department of General Surgery, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA.'}, {'ForeName': 'Beatrice P', 'Initials': 'BP', 'LastName': 'Concepcion', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.03.033'] 3245,31644357,"Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer.","PURPOSE We previously reported the safety and immunologic effects of a DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP) in patients with recurrent, nonmetastatic prostate cancer. The current trial evaluated the effects of this vaccine on metastatic progression. PATIENTS AND METHODS Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months were randomly assigned to treatment with either pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF alone six times at 14-day intervals and then quarterly for 2 years. The primary end point was 2-year metastasis-free survival (MFS). Secondary and exploratory end points were median MFS, changes in PSA DT, immunologic effects, and changes in quantitative 18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging. RESULTS Two-year MFS was not different between study arms (41.8% vaccine v 42.3%; P = .97). Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13). Preplanned subset analysis identified longer MFS in vaccine-treated patients with rapid (< 3 months) pretreatment PSA DT (12.0 v 6.1 months; n = 21; HR, 4.4; P = .03). PAP-specific T cells were detected in both cohorts, including multifunctional PAP-specific T-helper 1-biased T cells. Changes in total activity (total standardized uptake value) on 18 F-NaF PET/CT from months 3 to 6 increased 50% in patients treated with GM-CSF alone and decreased 23% in patients treated with pTVG-HP (n = 31; P = .07). CONCLUSION pTVG-HP treatment did not demonstrate an overall increase in 2-year MFS in patients with castration-sensitive prostate cancer, with the possible exception of a subgroup with rapidly progressive disease. Prespecified 18 F-NaF PET/CT imaging conducted in a subset of patients suggests that vaccination had detectable effects on micrometastatic bone disease. Additional trials using pTVG-HP in combination with PD-1 blockade are under way.",2019,"Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13).","['patients with recurrent, nonmetastatic prostate cancer', 'patients with castration-sensitive prostate cancer', 'Ninety-nine patients with castration-sensitive prostate cancer and prostate-specific antigen (PSA) doubling time (DT) of less than 12 months', 'Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer']","['GM-CSF', 'pTVG-HP co-administered intradermally with 200 μg granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant or 200 μg GM-CSF', 'DNA vaccine (pTVG-HP [MVI-816]) encoding prostatic acid phosphatase (PAP', 'DNA', 'Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816', 'vaccine', 'pTVG-HP treatment', 'pTVG-HP']","['PSA DT and median MFS', 'total activity (total standardized uptake value', 'micrometastatic bone disease', 'PAP-specific T cells', 'median MFS, changes in PSA DT, immunologic effects, and changes in quantitative 18 F-sodium fluoride (NaF) positron emission tomography/computed tomography (PET/CT) imaging', '2-year metastasis-free survival (MFS', '2-year MFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0523444', 'cui_str': 'Prostatic acid phosphatase measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.082602,"Changes in PSA DT and median MFS were not different between study arms (18.9 v 18.3 months; hazard ratio [HR], 1.6; P = .13).","[{'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Johnson', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Roth', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Perk', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeraj', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University of Wisconsin, Madison, WI.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01701'] 3246,31442204,Efficacy of osteopathic treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease: a randomized controlled pilot study.,"Background This randomized controlled pilot study evaluated the efficacy of osteopathic treatment in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) assessed using spirometry, COPD Assessment Test (CAT) and six minutes walking test (6MWT). The main goals were to improve the quality of life of patients with stable moderate-to-severe COPD, and to revise the parameters of the assessment tests, such as spirometry and 6MWT. Methods The study comprised several phases and patients were divided into two groups: group A (controls) received conventional pharmacological treatment with Indacaterol-Glycopyrronium and, while group B (OMT group) received both traditional therapy and osteopathic manipulative treatment (OMT) at different stages of the study. The osteopathic approach focused on maxillary sinus, vertebral-pleural ligaments, phrenic nerves, ribs, pleura, lungs, bronchi, subclavian muscles, and trapezoid and conoid ligaments. Results Overall, 32 patients were randomized and treated. Patients of the OMT group got better improvements in all tests compared to the control group: spirometry: FVC (p<0.5411), total FEV1 (p<0.5061); CAT: OMT (p<0.0005) - controls (p<0.188) 6MWT OMT (p<0.0038) - controls (p<0.5326). The clinical results collected in phase (T3) confirm those obtained in the first sessions; the results of CAT questionnaire (p<0.0005) and 6MWT (p 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). CONCLUSIONS Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection. TRIAL REGISTRATION NUMBER Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). ","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). ","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x'] 3264,32112263,"Effects of contact-based, short-term anti-stigma training for medical students : Results from a randomized controlled trial.","BACKGROUND Mental health stigma (MHS) places a burden on those affected that far exceeds psychosocial harms. Contact-based anti-stigma work has been found effective for several target groups. For medical students however, its efficacy remains unclear. AIM The purpose of this study was to examine the efficacy of contact-based, trialogic anti-stigma training for medical students. METHODS A randomized controlled trial (RCT) was conducted, controlling for standard clinical placement in psychiatry. External validity was maximized by including all students (n = 204) who started their 6‑week obligatory psychiatry course during the study period between March and July 2018. Assessments were conducted at the beginning of each of the two covered terms and immediately postintervention. RESULTS Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome. Analogous findings were noted for social distance and stereotypes, whereas these could not be observed for emotional reactions. All significant changes were independent of gender and age. CONCLUSION The positive results underpin the research in this field and point towards the inclusion of comparable interventions in regular student curricula. Given the limitation of a missing late follow-up, however, further research regarding the persistence of stigma reduction is needed.",2020,"RESULTS Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome.","['all students (n\u202f=\u2009204) who started their 6‑week obligatory psychiatry course during the study period between March and July 2018', 'medical students ', 'medical students']","['contact-based, short-term anti-stigma training', 'contact-based, trialogic anti-stigma training']","['External validity', ""MICA (Mental Illness-Clinicians' Attitudes) scale"", 'social distance and stereotypes', 'stigmatizing attitudes']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0066503', 'cui_str': 'Mica'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",,0.0557419,"RESULTS Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wechsler', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany. dominik.wechsler@gmx.de.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schomerus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Candelaria', 'Initials': 'C', 'LastName': 'Mahlke', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany.'}]","Neuropsychiatrie : Klinik, Diagnostik, Therapie und Rehabilitation : Organ der Gesellschaft Osterreichischer Nervenarzte und Psychiater",['10.1007/s40211-020-00337-x'] 3265,31391201,Paradoxical Rise in Hypoglycemia Symptoms With Development of Hyperglycemia During High-Intensity Interval Training in Type 1 Diabetes.,"OBJECTIVE To assess the reliability of self-perception of glycemia during high-intensity interval training (HIIT) in subjects with type 1 diabetes. RESEARCH DESIGN AND METHODS This randomized crossover study included subjects who completed four fasted HIIT sessions. Subjects answered the Edinburgh Hypoglycemia Scale, estimated their blood glucose (BG), and had plasma glucose (PG) collected throughout exercise and recovery. RESULTS As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05). Subjects' estimated BG showed a negative bias that widened as exercise progressed and peaked at -1.6 ± 3.3 mmol/L ( P < 0.001) postinsulin correction. CONCLUSIONS During HIIT, despite progressing hyperglycemia, subjects experience increased hypoglycemia symptoms and tend to underestimate their BG level.",2019,"As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05).","['subjects with type 1 diabetes (T1D', 'subjects who completed four fasted HIIT sessions', 'Hypoglycemia Symptoms With Development of Hyperglycemia']",['glycemia during high-intensity interval training (HIIT'],"['neuroglycopenic', 'hypoglycemia symptoms', 'exercise, hypoglycemia scores', 'Edinburgh Hypoglycemia Scale, estimated their blood glucose (BG), and had plasma glucose (PG) collected throughout exercise and recovery', 'nonspecific']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1331475', 'cui_str': 'Has development (attribute)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.0396343,"As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05).","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Potashner', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada ronnie.aronson@lmc.ca.'}]",Diabetes care,['10.2337/dc19-0609'] 3266,4067973,Factors affecting adenoidectomy for otitis media with effusion (glue ear).,"One hundred and fifty-five children suffering bilateral otitis media with effusion (OME) and observed for three months have been followed postoperatively for twelve months. Surgery was randomly allocated into three groups: adenotonsillectomy; adenoidectomy; and no surgery. In all cases unilateral myringotomy and grommet insertion was performed. The contralateral unoperated ear was assessed subsequently for clearance of the effusion. Adenoidectomy produced resolution of the effusion in 31-45% of cases at one year, but tonsillectomy conferred no additional benefit. There was improved resolution in those with longer compared with shorter histories, and in older as opposed to younger children. Assessment of preoperative lateral cephalometric radiographs show improved resolution of the effusion following removal of larger, compared with smaller adenoids, but this effect was only demonstrable for three months. The effect of age was longer-lasting for up to one year postoperatively.",1985,"Assessment of preoperative lateral cephalometric radiographs show improved resolution of the effusion following removal of larger, compared with smaller adenoids, but this effect was only demonstrable for three months.","['One hundred and fifty-five children suffering bilateral otitis media with effusion (OME', 'otitis media with effusion (glue ear']","['adenotonsillectomy; adenoidectomy; and no surgery', 'Adenoidectomy']",['resolution of the effusion'],"[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0856467', 'cui_str': 'Bilateral otitis media'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy (procedure)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}]",155.0,0.120844,"Assessment of preoperative lateral cephalometric radiographs show improved resolution of the effusion following removal of larger, compared with smaller adenoids, but this effect was only demonstrable for three months.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Maw', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3267,31397290,Blood pressure control and clinical outcomes in acute intracerebral haemorrhage: a preplanned pooled analysis of individual participant data.,"BACKGROUND Uncertainty persists over the effects of blood pressure lowering in acute intracerebral haemorrhage. We aimed to combine individual patient-level data from the two largest randomised controlled trials of blood pressure lowering strategies in patients with acute intracerebral haemorrhage to determine the strength of associations between key measures of systolic blood pressure control and safety and efficacy outcomes. METHODS We did a preplanned pooled analysis of individual patient-level data acquired from the main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial. These trials included adult patients aged 19-99 years with spontaneous (non-traumatic) intracerebral haemorrhage and elevated systolic blood pressure, without a clear indication or contraindication to treatment. Patients were excluded if they had a structural cerebral cause for the intracerebral haemorrhage, had a low score (3-5) on the Glasgow Coma Scale, or required immediate neurosurgery. Our primary analysis assessed the independent associations between three post-randomisation systolic blood pressure summary measures-magnitude of reduction in 1 h, mean achieved systolic blood pressure, and variability in systolic blood pressure between 1 h and 24 h-and the primary outcome of functional status, as defined by the distribution of scores on the modified Rankin Scale at 90 days post-randomisation. We analysed the systolic blood pressure measures as continuous variables using generalised linear mixed models, adjusted for baseline covariables and trial. The primary and safety analyses were done in a modified intention-to-treat population, which only included patients with sufficient data on systolic blood pressure. FINDINGS 3829 patients (mean age 63·1 years [SD 12·9], 1429 [37%] women, and 2490 [65%] Asian ethnicity) were randomly assigned in INTERACT2 and ATACH-II, with a median neurological impairment defined by scores on the National Institutes of Health Stroke Scale of 11 (IQR 6-16) and median time from the onset of symptoms of intracerebral haemorrhage to randomisation of 3·6 h (2·7-4·4). We excluded 20 patients with insufficient or no systolic blood pressure data, and we imputed missing systolic blood pressure data in 23 (1%) of the remaining 3809 patients. Overall, the mean magnitude of early systolic blood pressure reduction was 29 mm Hg (SD 22), and subsequent mean systolic blood pressure achieved was 147 mm Hg (15) and variability in systolic blood pressure was 14 mm Hg (8). Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001). Symptomatic hypotension occurred in 28 (1%) patients, renal serious adverse events occurred in 26 (1%) patients, and cardiac serious adverse events occurred in 99 (3%) patients. INTERPRETATION Our pooled analyses indicate that achieving early and stable systolic blood pressure seems to be safe and associated with favourable outcomes in patients with acute intracerebral haemorrhage of predominantly mild-to-moderate severity. FUNDING None.",2019,"Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001).","['20 patients with insufficient or no systolic blood pressure data, and we imputed missing systolic blood pressure data in 23 (1%) of the remaining 3809 patients', 'patients with acute intracerebral haemorrhage', '3829 patients (mean age 63·1 years [SD 12·9], 1429 [37%] women, and 2490', 'patients with acute intracerebral haemorrhage of predominantly mild-to-moderate severity', 'We did a preplanned pooled analysis of individual patient-level data acquired from the main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial', 'adult patients aged 19-99 years with spontaneous (non-traumatic) intracerebral haemorrhage and elevated systolic blood pressure, without a clear indication or contraindication to treatment', 'acute intracerebral haemorrhage', 'Patients were excluded if they had a structural cerebral cause for the intracerebral haemorrhage, had a low score (3-5) on the Glasgow Coma Scale, or required immediate neurosurgery', '65%] Asian ethnicity']",['blood pressure lowering strategies'],"['systolic blood pressure measures', 'mean magnitude of early systolic blood pressure reduction', 'Symptomatic hypotension', 'systolic blood pressure', 'systolic blood pressure control and safety and efficacy outcomes', 'mean systolic blood pressure', 'renal serious adverse events', 'cardiac serious adverse events', 'systolic blood pressure, and variability in systolic blood pressure', 'Blood pressure control and clinical outcomes', 'modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",3829.0,0.233463,"Achieved systolic blood pressure was continuously associated with functional status (improvement per 10 mm Hg increase adjusted odds ratio [OR] 0·90 [95% CI 0·87-0·94], p<0·0001).","[{'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Moullaali', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Shipes', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO, USA; Zeenat Qureshi Stroke Institute, St. Cloud, MO, USA.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; George Institute China at Peking University Health Science Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30196-6'] 3268,3944815,Atropine or glycopyrrolate with neostigmine 5 mg: a comparative dose-response study.,"One hundred and fifteen patients, separated into 4 groups, received neostigmine 5 mg with either atropine 1.2 mg or 1.8 mg, or glycopyrrolate 0.6 mg or 0.9 mg. Those receiving 0.9 mg glycopyrrolate had insignificant changes in heart rate in the immediate postreversal period. It is recommended that when glycopyrrolate is used with 5 mg neostigmine, the optimum dose is 0.9 mg.",1986,Those receiving 0.9 mg glycopyrrolate had insignificant changes in heart rate in the immediate postreversal period.,['One hundred and fifteen patients'],"['neostigmine 5 mg with either atropine 1.2 mg or 1.8 mg, or glycopyrrolate 0.6 mg or 0.9 mg', 'Atropine or glycopyrrolate with neostigmine', 'glycopyrrolate', 'neostigmine']",['heart rate'],"[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0151834,Those receiving 0.9 mg glycopyrrolate had insignificant changes in heart rate in the immediate postreversal period.,"[{'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Salem', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Ahearn', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3269,32105267,[A double blind placebo controlled randomized clinical trial of the efficacy and safety of pregabalin in induction of remission in patients with alcohol dependence].,"AIM To study the efficacy of pregabalin for relapse prevention and reduction of drinking in patients with alcohol dependence. MATERIAL AND METHODS One hundred recently detoxified out-patients with alcohol dependence were randomly assigned to one of two treatment groups. Patients of the first group (n=50; 38 men, 12 women, age 43.0±1.27) received pregabalin (150 mg once a day at night time) for 3 months, while patients of the second group (n=50; 45 men, 5 women, age 45.92±1.4) received identically looking placebo. All patients received standardized manualized weekly counseling (medical management). Drinking was measured on the weekly basis with Time Line Follow Back technique and GGT enzyme activity. Also, craving for alcohol, depression, and anxiety were measured weekly with the number of scales. RESULTS Kaplan-Meier survival analysis demonstrated significantly higher retention in treatment and in remission in the pregabalin group (lower drop out and relapse rate) mediana (CL)-12 (10.4-13.6) weeks in the pregabalin group vs. 6 (4.5-7.5) in the placebo group, Log Rank Mantel-Cox test = 0.005). Proportion of patients, who completed treatment in the pregabalin group, was significantly higher compared to the placebo group: 50% vs. 24%. Mean duration of participation in the treatment program was also higher in the pregabalin group: 9.1±0.5 weeks vs. 7.1±0.5 in the placebo group. General linear model demonstrated the significant treatment group effect on: (1) total alcohol consumption (TAC) (mean grams of alcohol per day) with lower TAC in the pregabalin group and (2) on the number of heavy drinking days (NHDD) with lower NHDD in the pregabalin group. Mean NHDD per patient for the period of participation in the study was lower in the pregabalin group (3.6±0.7 vs. 6.4±0.8; p=0.009), while the mean number of abstinent (sober) days was higher (55.9±3.6 vs. 40.0±3.3; p=0.001). No significant differences between the two groups were found in the scores on craving for alcohol, depression and anxiety scales. GGT activity was also similar in both groups throughout the study with no significant between group differences. The rate of adverse events (sleepiness, dizziness, and headache) was insignificantly higher in the pregabalin group compared with the placebo group. All adverse events were mild, gradually disappeared, and did not require any medication. CONCLUSION Results of this study provide evidence that pregabalin in a low dose of 150 mg per day is an effective and safe medication for relapse prevention and reduction of drinking in patients with alcohol dependence.",2020,"Proportion of patients, who completed treatment in the pregabalin group, was significantly higher compared to the placebo group: 50% vs. 24%.","['Patients of the first group (n=50; 38 men, 12 women, age 43.0±1.27) received', 'One hundred recently detoxified out-patients with alcohol dependence', 'patients with alcohol dependence']","['placebo', 'identically looking placebo', 'pregabalin', 'standardized manualized weekly counseling (medical management']","['Mean NHDD', 'efficacy and safety', 'total alcohol consumption (TAC', 'craving for alcohol, depression and anxiety scales', 'mean number of abstinent (sober) days', 'number of heavy drinking days (NHDD', 'rate of adverse events (sleepiness, dizziness, and headache', 'Mean duration of participation', 'relapse rate) mediana (CL)-12', 'craving for alcohol, depression, and anxiety', 'GGT activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0341279,"Proportion of patients, who completed treatment in the pregabalin group, was significantly higher compared to the placebo group: 50% vs. 24%.","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Krupitsky', 'Affiliation': 'National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia; First St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Rybakova', 'Affiliation': 'National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Skurat', 'Affiliation': 'National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Semenova', 'Affiliation': 'National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Neznanov', 'Affiliation': 'National Medical Research Center for Psychiatry and Neurology, St. Petersburg, Russia; First St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012001133'] 3270,28377342,[Efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery arteriosclerosis obliterans: prospective randomized controlled triac].,"OBJECTIVE To compared the efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery occlusive disease. METHODS Forty-six patients were admitted for ipsilateral single or multiple superficial femoral artery and/or popliteal artery lesions (between 3 and 15 cm stenosis or occlusion), Rutherford grades 2 to 5, with or without other accompanying diseases in the Department of Interventional Vascular Therapy of the First Hospital of Nanjing between September, 2015 and December, 2016. The patients were randomly assigned into drug-coated balloon (DCB) group (n=23) and common balloon (CB) group (n=23). None of the patients had stent restenosis, aneurysms, acute thrombosis, pregnancy, life expectancy less than 1 year, or below-the-knee artery occlusion. The late lumen loss (LLL), improvement of the ankle brachial index (ABI), improvement of Rutherford grade, incidence of restenosis, thrombosis rate and amputation rate were compared between the two groups at 6 months after treatment. RESULTS The two groups of patients were comparable for general conditions, risk factors, and characteristics of the compromised vessels (P>0.05). Six months after treatment, the patients in DCB group showed significantly smaller LLL, more obvious improvement of the ABI and Rutherford grade, and lower restenosis rate and thrombosis rate than those in CB group (P<0.05). The amputation rates were similar between the two groups (P>0.05). CONCLUSIONS DCB shows obvious advantages over common balloon for treatment of superficial artery and popliteal artery arteriosclerosis obliterans in that it more effectively reduces LLL, restenosis rate and thrombosis rate and improves the ABI and Rutherford grade at 6 months after the treatment.",2017,"None of the patients had stent restenosis, aneurysms, acute thrombosis, pregnancy, life expectancy less than 1 year, or below-the-knee artery occlusion.","['superficial femoral artery and popliteal artery occlusive disease', 'Forty-six patients were admitted for ipsilateral single or multiple superficial femoral artery and/or popliteal artery lesions (between 3 and 15 cm stenosis or occlusion), Rutherford grades 2 to 5, with or without other accompanying diseases in the Department of Interventional Vascular Therapy of the First Hospital of Nanjing between September, 2015 and December, 2016', 'superficial femoral artery and popliteal artery arteriosclerosis obliterans']","['drug-coated balloon (DCB) group (n=23) and common balloon (CB', 'drug-coated balloon and common balloon']","['amputation rates', 'smaller LLL', 'late lumen loss (LLL), improvement of the ankle brachial index (ABI), improvement of Rutherford grade, incidence of restenosis, thrombosis rate and amputation rate', 'ABI and Rutherford grade, and lower restenosis rate and thrombosis rate', 'LLL, restenosis rate and thrombosis rate', 'stent restenosis, aneurysms, acute thrombosis, pregnancy, life expectancy']","[{'cui': 'C0447106', 'cui_str': 'Superficial femoral artery (body structure)'}, {'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003851', 'cui_str': 'Arteriosclerosis Obliterans'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}]","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",46.0,0.0417523,"None of the patients had stent restenosis, aneurysms, acute thrombosis, pregnancy, life expectancy less than 1 year, or below-the-knee artery occlusion.","[{'ForeName': 'Jing-Yuan', 'Initials': 'JY', 'LastName': 'Lu', 'Affiliation': 'Department of Interventional Radiology, Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing 210006, China.E-mail: ljyxy249@qq.com.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Wen-Jian', 'Initials': 'WJ', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wen-Sheng', 'Initials': 'WS', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3271,31682584,Effects of a Smartphone-Based Approach-Avoidance Intervention on Chocolate Craving and Consumption: Randomized Controlled Trial.,"BACKGROUND Repeatedly pushing high-calorie food stimuli away based on joystick movements has been found to reduce approach biases toward these stimuli. Some studies also found that such avoidance training reduced consumption of high-calorie foods. OBJECTIVE This study aimed to test effects of a smartphone-based approach-avoidance intervention on chocolate craving and consumption, to make such interventions suitable for daily use. METHODS Within a 10-day period, regular chocolate eaters (n=105, 86% female) performed five sessions during which they continuously avoided (ie, swiped upward) chocolate stimuli (experimental group, n=35), performed five sessions during which they approached and avoided chocolate stimuli equally often (placebo control group, n=35), or did not perform any training sessions (inactive control group, n=35). Training effects were measured during laboratory sessions before and after the intervention period and further continuously through daily ecological momentary assessment. RESULTS Self-reported chocolate craving and consumption as well as body fat mass significantly decreased from pre- to postmeasurement across all groups. Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group. CONCLUSIONS A smartphone-based approach-avoidance training did not affect eating-related and anthropometric measures over and above measurement-based changes in this study. Future controlled studies need to examine whether other techniques of modifying food approach tendencies show an add-on benefit over conventional, monitoring-based intervention effects. TRIAL REGISTRATION AsPredicted 8203; https://aspredicted.org/pt9df.pdf.",2019,"Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group. ",[],"['five sessions during which they continuously avoided (ie, swiped upward) chocolate stimuli (experimental group, n=35), performed five sessions during which they approached and avoided chocolate stimuli equally often (placebo control group, n=35), or did not perform any training sessions (inactive control', 'Smartphone-Based Approach-Avoidance Intervention', 'smartphone-based approach-avoidance training', 'smartphone-based approach-avoidance intervention']","['chocolate craving and consumption', 'Chocolate Craving and Consumption', 'body fat mass']",[],"[{'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1533153', 'cui_str': 'Fives'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0312922,"Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group. ","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Meule', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Richard', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Radomir', 'Initials': 'R', 'LastName': 'Dinic', 'Affiliation': 'Department of MultiMediaTechnology, Salzburg University of Applied Sciences, Puch, Austria.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blechert', 'Affiliation': 'Department of Psychology, University of Salzburg, Salzburg, Austria.'}]",JMIR mHealth and uHealth,['10.2196/12298'] 3272,28446396,[Application of thoracic paravertebral nerve block in video-assisted thoracosopic surgery: a randomized controlled trial].,"OBJECTIVE To investigate the effect of a single dose of ropivacaine combined with sufentanilfor thoracic paravertebral block (TPVB) on pain and enhanced recovery after surgery (ERAS) in patients undergoing video-assisted thoracosopic surgery. METHODS Sixty patients undergoing video-assisted thoracosopic surgery were randomly divided into three groups to receive intravenous combined general anesthesia (group C), a single dose of ropivacainefor thoracic paravertebral block before surgery combined with intravenous and general anesthesia(group T 1 ), or a single dose of ropivacaineand sufentanilfor thoracic paravertebral blockcombined with intravenous and general anesthesia (group T 2 ). None of the patients used postoperative analgesia pump, and tramadol hydrochoride injection (100 mg) was given in cases with NRS scores > 4 after the surgery. The data were recorded including analgesics used for nerve block before the operation, intravenous dosage of sufentanilduring operation, total dose of sufentanilused (intravenous+nerve block), intravenous remifentanil dose during operation, NRS scores at 4, 6, 24, 48 h after the surgery, rescue analgesia in the first postoperative 24 h after surgery, ICU stay and hospital stay after the surgery. RESULTS Compared with those in group C, the intravenous sufentanildose, total sufentanildose, intravenous remifentanildose during operation, NRS scores at 4 and 6, 24 h, and ICU stay and hospital stay after the surgery were significantly decreased in groups T 1 and T 2 (P<0.05). The total dose of opioids during the operation and NRS scores at 4 and 6 h were significantly lower in group T 2 than in group T 1 (P<0.05), but the total dose of sufentanil, ICU stay and hospital stay were simialr between the two groups. CONCLUSION A single dose of ropivacaine combined with sufentanilfor thoracic paravertebral blockbefore surgery can reduce the total dose opioids, produce the optimal analgesic effect, and promote postoperative recovery of the patients.",2016,"The total dose of opioids during the operation and NRS scores at 4 and 6 h were significantly lower in group T 2 than in group T 1 (P<0.05), but the total dose of sufentanil, ICU stay and hospital stay were simialr between the two groups. ","['Sixty patients undergoing video-assisted thoracosopic surgery', 'patients undergoing video-assisted thoracosopic surgery']","['ropivacainefor thoracic paravertebral block before surgery combined with intravenous and general anesthesia(group T 1 ), or a single dose of ropivacaineand sufentanilfor thoracic paravertebral blockcombined with intravenous and general anesthesia', 'tramadol hydrochoride injection', 'surgery (ERAS', 'video-assisted thoracosopic surgery', 'ropivacaine combined with sufentanilfor thoracic paravertebral block (TPVB', 'ropivacaine combined with sufentanilfor thoracic paravertebral blockbefore surgery', 'sufentanilduring operation, total dose of sufentanilused (intravenous+nerve block), intravenous remifentanil', 'intravenous combined general anesthesia', 'thoracic paravertebral nerve block']","['intravenous sufentanildose, total sufentanildose, intravenous remifentanildose during operation, NRS scores', 'ICU stay and hospital stay', 'total dose of sufentanil, ICU stay and hospital stay', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia (procedure)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]",60.0,0.0655203,"The total dose of opioids during the operation and NRS scores at 4 and 6 h were significantly lower in group T 2 than in group T 1 (P<0.05), but the total dose of sufentanil, ICU stay and hospital stay were simialr between the two groups. ","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China. E-mail: 313854855@qq.com.'}, {'ForeName': 'Dan-Yan', 'Initials': 'DY', 'LastName': 'Liu', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3273,32098534,2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene.,"Background and purpose - The long-term survival of arthroplasty components may be limited by polyethylene wear-related problems such as periprosthetic osteolysis and aseptic loosening. Highly cross-linked polyethylene (HXLPE) blended with vitamin E was introduced to improve oxidative stability and to avoid long-term embrittlement. This study clinically compares the tribological behavior and clinical outcome of vitamin E blended HXLPE with ultra-high molecular weight polyethylene (UHMWPE) in an isoelastic monoblock cup for uncemented total hip arthroplasty. Patients and methods - In this randomized controlled trial (RCT), 199 patients were included: 102 patients received the vitamin E blended HXLPE cup, 97 patients the UHMWPE cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperative and at 3, 12, and 24 months. Wear rates were compared using the mean linear femoral head penetration (FHP) rate. Results - 188 patients (94%) completed the 2-year follow-up. Mean patient satisfaction was higher in the vitamin E blended HXLPE group (8.9 [1]) than in in the control group (8.5 [2], p = 0.03). The Harris Hip Score (HHS) was higher in the vitamin E blended HXLPE group (95 [8]) than in the control group (92 [11], p = 0.3). The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed during follow-up, with an excellent 2-year survival to revision rate of 98% for both cups. Interpretation - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with lower linear femoral head penetration rates and better clinical results compared with the UHMWPE acetabular cup after 2 years.",2020,The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05).,"['199 patients were included: 102 patients received the', 'uncemented total hip arthroplasty']","['HXLPE blended with vitamin E acetabular cup', 'vitamin E blended HXLPE', 'Highly cross-linked polyethylene (HXLPE) blended with vitamin E', 'RCT', 'vitamin E blended HXLPE cup', 'vitamin E blended HXLPE with ultra-high molecular weight polyethylene (UHMWPE', 'vitamin E', 'UHMWPE acetabular cup']","['Mean patient satisfaction', '2-year survival to revision rate', 'FHP rate', 'oxidative stability', 'Harris Hip Score (HHS', 'Wear rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0673477', 'cui_str': 'UHMWPE'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}]",199.0,0.144797,The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05).,"[{'ForeName': 'Joost H J', 'Initials': 'JHJ', 'LastName': 'van Erp', 'Affiliation': 'Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.'}, {'ForeName': 'Julie R A', 'Initials': 'JRA', 'LastName': 'Massier', 'Affiliation': 'Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.'}, {'ForeName': 'Jelle J', 'Initials': 'JJ', 'LastName': 'Halma', 'Affiliation': 'Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.'}, {'ForeName': 'Thom E', 'Initials': 'TE', 'LastName': 'Snijders', 'Affiliation': 'Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'de Gast', 'Affiliation': 'Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.'}]",Acta orthopaedica,['10.1080/17453674.2020.1730073'] 3274,32107188,"Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Retinal Vein Occlusion: The Bevacizumab to Ranibizumab in Retinal Vein Occlusions (BRVO) study, a Randomized Trial.","PURPOSE Comparing the efficacy of intravitreal injections of bevacizumab to ranibizumab in the treatment of macular edema (ME) resulting from retinal vein occlusion (RVO). DESIGN Comparative, randomized, double-masked, multicenter, noninferiority clinical trial. The noninferiority margin was 4 letters. PARTICIPANTS Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti-vascular endothelial growth factor treatment were eligible for participation. METHODS From June 2012 through February 2018, 277 participants were randomized to receive injections of 1.25 mg bevacizumab (n = 139) or 0.5 mg ranibizumab (n = 138). The follow-up was 6 months with a monthly dosing interval. MAIN OUTCOME MEASURES The primary outcome was a change in visual acuity from baseline at 6 months. Changes in the central area thickness and safety were studied as secondary outcomes. RESULTS The mean visual acuity (±standard deviation) improved, with 15.3±13.0 letters for bevacizumab and 15.5±13.3 letters for ranibizumab after 6 months of monthly treatment. The lower limit of the 2-sided 90% confidence interval was -1.724 letters, which is within the noninferiority margin of 4 letters. Even in the branch and (hemi-)central RVO subgroups, minimal differences were found in visual acuity outcomes between treatment arms. Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group. Severe adverse events (SAEs) were also distributed equally over both treatment groups: 10 participants (7.1%) in the bevacizumab group and 13 participants (9.2%) in the ranibizumab group experienced SAEs. CONCLUSIONS This study showed, based on the change in visual acuity, that bevacizumab is noninferior to ranibizumab for patients with ME resulting from RVO of either subtype when receiving monthly injections for a period of 6 months. In addition, anatomic and safety outcomes did not differ between treatment groups. Based on our findings, bevacizumab may be an effective alternative to ranibizumab.",2020,"Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group.","['From June 2012 through February 2018, 277 participants', 'Retinal Vein Occlusions (BRVO', 'patients with ME', 'Patients with Retinal Vein Occlusion', 'Patients with vision loss resulting from ME secondary to a branch or (hemi) central RVO who might benefit from anti-vascular endothelial growth factor treatment were eligible for participation', 'macular edema (ME) resulting from retinal vein occlusion (RVO']","['bevacizumab to ranibizumab', 'ranibizumab', 'bevacizumab', 'Bevacizumab and Ranibizumab', 'Bevacizumab to Ranibizumab']","['Severe adverse events (SAEs', 'anatomic and safety outcomes', 'change in visual acuity', 'central area thickness on OCT', 'visual acuity outcomes', 'visual acuity', 'mean visual acuity (±standard deviation']","[{'cui': 'C0035328', 'cui_str': 'Retinal Vein Occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",277.0,0.329751,"Changes in central area thickness on OCT at 6 months did not differ significantly between treatment groups, with a decrease of 287.0±231.3 μm in the bevacizumab group and 300.8±224.8 μm in the ranibizumab group.","[{'ForeName': 'Maartje J C', 'Initials': 'MJC', 'LastName': 'Vader', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ann-Sofie M E', 'Initials': 'AME', 'LastName': 'Schauwvlieghe', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Verbraak', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Greetje', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johanna M M', 'Initials': 'JMM', 'LastName': 'Hooymans', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Leonoor I', 'Initials': 'LI', 'LastName': 'Los', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Ophthalmology, Queens University Belfast, Belfast, United Kingdom.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Vingerling', 'Affiliation': 'Department of Ophthalmology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'de Jong-Hesse', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke J C', 'Initials': 'JJC', 'LastName': 'van Lith-Verhoeven', 'Affiliation': 'Department of Ophthalmology, Elisabeth-Twee Steden (ETZ) Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinier O', 'Initials': 'RO', 'LastName': 'Schlingemann', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands; Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland. Electronic address: r.o.schlingemann@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.12.019'] 3275,32106328,The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting? - Reproducibility of the Renal Resistive Index.,"PURPOSE To assess the reproducibility of the renal resistive index (RRI) in a routine clinical setting. MATERIALS AND METHODS 22 patients with a kidney allograft and 19 physicians participated in our prospective study. Within 2 hours each patient was examined by 5 different physicians using 2 out of 3 different, randomly allocated ultrasound machines. Each investigator determined the hilar and parenchymal RRI of the allograft. The reproducibility and reproducibility limit of the RRI were assessed as well as Cronbach's alpha and the intraclass correlation coefficient (ICC). The deviation of the RRI from the mean RRI over the 5 measurements was used as an indicator of reproducibility. The impact of the ultrasound machine, examiner's level of experience, and kidney function impairment (GFR < 45 ml/min) was assessed with the Kruskal-Wallis test. The bivariate linear correlation of the minimal transplant distance from the body surface with the variance of the parenchymal RRI was analyzed. RESULTS A reproducibility of 0.045 with a reproducibility limit of 0.124 was found for the parenchymal RRI. The ICC between RRIs was good with 0.852 for the parenchymal RRI and 0.868 for the hilar RRI. The type of ultrasound machine used was found to have a significant impact on the deviation of the parenchymal RRI (Kruskal-Wallis-Test, p = 0.003). Variance in serial parenchymal RRI measurements correlated significantly with the depth of the kidney transplant (p = 0.001). CONCLUSION While the RRI is generally sufficiently reproducible, the type of ultrasound machine used and the depth of the kidney transplant within the recipient's body have a significant impact on reproducibility. KEY POINTS · The renal resistive index (RRI) in allografts is reproducible.. · The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient.. CITATION FORMAT · Theilig DC, Münzfeld H, Auer TA et al. The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting?. Fortschr Röntgenstr 2020; 192: 561 - 566.",2020,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient.. CITATION FORMAT · Theilig DC, Münzfeld H, Auer TA et al.",['22 patients with a kidney allograft and 19 physicians participated in our prospective study'],[],"['Variance in serial parenchymal RRI measurements', 'reproducibility of the renal resistive index (RRI', 'Renal Resistive Index in Allografts', 'hilar and parenchymal RRI of the allograft', 'reproducibility and reproducibility limit of the RRI', 'deviation of the parenchymal RRI', 'renal resistive index (RRI', 'Renal Resistive Index', ' Reproducibility of the Renal Resistive Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]",[],"[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",22.0,0.0197898,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient.. CITATION FORMAT · Theilig DC, Münzfeld H, Auer TA et al.","[{'ForeName': 'Dorothea Cornelia', 'Initials': 'DC', 'LastName': 'Theilig', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Münzfeld', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Timo Alexander', 'Initials': 'TA', 'LastName': 'Auer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Feldhaus', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Krüger', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dürr', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Geisel', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}]",RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin,['10.1055/a-1086-5191'] 3276,29502050,[Prognostic analysis of plantar fasciitis treated by pneumatic ballistic extracorporeal shock wave versus ultrasound guided intervention].,"OBJECTIVE To compare the medium- and long-term effect of pneumatic ballistic extracorporeal shock wave versus ultrasound-guided hormone injection in the treatment of plantar fasciitis. METHODS The clinical data were collected from patients with plantar fasciitis admitted to PLA General Hospital pain department from September, 2015 to February, 2017. The patients were randomly divided into ultrasound-guided drug injection group and shock wave group. The therapeutic parameters including the numerical rating scale (NRS) scores in the first step pain in the morning, American Orthopedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Scale, and thickness of the plantar fascia were monitored before and at 1 week, 1 month, 3 months, and 6 months after the treatment. The recurrence rate, effectiveness, and patient satisfaction were compared between the two groups at 6 months after the treatment. RESULTS Thirty-nine patients were enrolled in shock wave group and 38 patients in ultrasound group. The NRS scores in the first step pain in the morning were lowered after treatment in both groups (P<0.05), and the scores were significantly lower in ultrasound group than in shock wave group at 1 week and 1 month (P<0.01), but significantly higher in ultrasound group than in shock wave group at 3 and 6 months after treatment (P<0.05). The AOFAS functional scores were increased in both groups (P<0.05) at 6 months after treatment, was significantly lower in ultrasound group than in shock wave group than group B (90.44∓13.27 vs 75.76∓21.40; P<0.05). The effective rates in shock wave group and ultrasound group were 92.31% and 76.32%, respectively (P<0.05). Recurrence was found in 1 patient (2.56%) in shock wave group and in 8 (21.05%) in ultrasound group (P<0.05). The patient satisfaction scores were significantly higher in shock wave group than in ultrasound group (8.13∓2.67 vs 6.63∓3.75, P=0.048). CONCLUSION Pneumatic ballistic extracorporeal shock achieves better medium- and long-term outcomes than ultrasound-guided hormone injection in the treatment of plantar fasciitis.",2018,"The NRS scores in the first step pain in the morning were lowered after treatment in both groups (P<0.05), and the scores were significantly lower in ultrasound group than in shock wave group at 1 week and 1 month (P<0.01), but significantly higher in ultrasound group than in shock wave group at 3 and 6 months after treatment (P<0.05).","['Thirty-nine patients were enrolled in shock wave group and 38 patients in ultrasound group', 'plantar fasciitis', 'patients with plantar fasciitis admitted to PLA General Hospital pain department from September, 2015 to February, 2017']","['ultrasound-guided drug injection group and shock wave group', 'pneumatic ballistic extracorporeal shock wave versus ultrasound guided intervention', 'ultrasound-guided hormone injection', 'pneumatic ballistic extracorporeal shock wave versus ultrasound-guided hormone injection', 'Pneumatic ballistic extracorporeal shock']","['American Orthopedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Scale, and thickness of the plantar fascia', 'patient satisfaction scores', 'effective rates', 'recurrence rate, effectiveness, and patient satisfaction', 'Recurrence', 'numerical rating scale (NRS) scores', 'AOFAS functional scores', 'NRS scores']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C1257942', 'cui_str': 'Ballistics'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C0222045'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",39.0,0.0282985,"The NRS scores in the first step pain in the morning were lowered after treatment in both groups (P<0.05), and the scores were significantly lower in ultrasound group than in shock wave group at 1 week and 1 month (P<0.01), but significantly higher in ultrasound group than in shock wave group at 3 and 6 months after treatment (P<0.05).","[{'ForeName': 'Xiu-Lin', 'Initials': 'XL', 'LastName': 'Huo', 'Affiliation': 'Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, China. E-mail: 18801211351@163.com.'}, {'ForeName': 'Ke-Tao', 'Initials': 'KT', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yi-Tian', 'Initials': 'YT', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Fu-Yang', 'Initials': 'FY', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Wei-Xiu', 'Initials': 'WX', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Mi', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3277,29292259,[Comparison of safe duration of apnea and intubation time in face mask ventilation with air versus 100% oxygen during induction of general anesthesia].,"OBJECTIVE To compare the safe duration of apnea and intubation time between face mask ventilation with air and 100% oxygen during induction of general anesthesia. METHODS Eighty adult patients with ASA class I or II without predicted difficult airways were scheduled for elective surgery under general anesthesia. The patients were randomized to receive anesthesia induction with preoxygenation [Group 1, n=40, fraction of inspired oxygen (FiO 2 )=1] or without preoxygenation (Group2, n=40, FiO 2 =0.21). Two experienced anesthesiologists performed the mask ventilation and tracheal intubation during induction, and the assistants adjusted the oxygen concentration and recorded the pulse oxygen saturation (SpO 2 ) and other variables. The cases where SpO 2 decreased to below 90% before accomplishment of intubation were considered unsuccessful, and mask ventilation with 100% oxygen was given. After tracheal intubation, mechanical ventilation was not initiated until the SpO 2 decreased to 90%. The number of unsuccessful cases, the safe duration of apnea and intubation time were recorded in the two groups. RESULTS There was no unsuccessful case in either groups. The safe duration of apnea was 469.5∓143.0 s in Group 1 and 63.6∓20.0 s in Group 2, and the intubation time was 34.4∓12.6 s and 32.8∓9.6 s, respectively. The safe duration of apnea was significantly longer than the intubation time in both groups (P<0.01). The intubation time and the number of cases with SpO 2 ≥90% before completion of tracheal intubation were similar between the two groups. The safe duration of apnea was significantly shorter in Group 2 than in Group 1 (P<0.01) and was correlated with the body mass index of the patients (P<0.05). CONCLUSION Anesthesia induction without preoxygenation can provide sufficient time for experienced anesthesiologists to complete tracheal intubation.",2017,"The safe duration of apnea was significantly shorter in Group 2 than in Group 1 (P<0.01) and was correlated with the body mass index of the patients (P<0.05). ","['Eighty adult patients with ASA class', 'general anesthesia']","['anesthesia induction with preoxygenation [Group 1, n=40, fraction of inspired oxygen (FiO 2 )=1] or without preoxygenation']","['safe duration of apnea and intubation time', 'intubation time', 'number of unsuccessful cases, the safe duration of apnea and intubation time', 'safe duration of apnea']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation (procedure)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",80.0,0.0227944,"The safe duration of apnea was significantly shorter in Group 2 than in Group 1 (P<0.01) and was correlated with the body mass index of the patients (P<0.05). ","[{'ForeName': 'Zi-Jia', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesia, Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou 510655, China. E-mail: today3800@163.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ying-Yin', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'San-Qing', 'Initials': 'SQ', 'LastName': 'Jin', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3278,28951372,[Prior periodontal intervention lowers incidence of lower respiratory infection in patients receiving oral and maxillofacial tumor surgery].,"OBJECTIVE To investigate whether periodontal infection is a risk factor for lower respiratory infection patients receiving oral and maxillofacial tumor surgery. METHODS Patients undergoing oral and maxillofacial surgery for tumors with concurrent periodontal disease between January, 2012 and December, 2016 were randomized into periodontal intervention group and control group (treated with gargle solution containing chlorhexidine gluconate). The one-time periodontal intervention was completed within 24 h in the intervention group and two-week mouthwash was prescribed in the control group before oral and maxillofacial tumor surgery. Five periodontal indexes were examined at baseline and at 6 weeks after the treatment. The clinical symptoms and incidence of lower respiratory infections were compared between the two groups at 6 weeks. RESULTS The PLI, BOP, PPD, and CAL were significantly lower and GR was higher in the intervention group than in the control group (P<0.01). The periodontal status was significantly improved in the intervention group. The incidence of lower respiratory infection was significantly lower in the intervention group than in the control group (2.22% vs 7.11%, P<0.01). The incidences of cough and expectoration in the intervention group were significantly lower than those in control group (P<0.01). CONCLUSIONS Periodontal infection is one of the risk factors for lower respiratory infection after oral and maxillofacial tumor surgery. The periodontal status can be effectively controlled and improved by periodontal intervention. Compared with mouthwash, periodontal intervention can significantly reduce the incidences of cough and expectoration and lower the incidence of lower respiratory infections.",2017,"The PLI, BOP, PPD, and CAL were significantly lower and GR was higher in the intervention group than in the control group (P<0.01).","['lower respiratory infection patients receiving oral and maxillofacial tumor surgery', 'patients receiving oral and maxillofacial tumor surgery', 'Patients undergoing oral and maxillofacial surgery for tumors with concurrent periodontal disease between January, 2012 and December, 2016 were randomized into']","['periodontal intervention group and control group (treated with gargle solution containing chlorhexidine gluconate', 'periodontal intervention']","['clinical symptoms and incidence of lower respiratory infections', 'PLI, BOP, PPD, and CAL', 'periodontal status', 'incidences of cough and expectoration and lower the incidence of lower respiratory infections', 'incidence of lower respiratory infection', 'incidences of cough and expectoration']","[{'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.016145,"The PLI, BOP, PPD, and CAL were significantly lower and GR was higher in the intervention group than in the control group (P<0.01).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Stomatology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.E-mail: youqijie@163.com.'}, {'ForeName': 'Ya-Jie', 'Initials': 'YJ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Li-Yan', 'Initials': 'LY', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3279,32092309,Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis.,"BACKGROUND & AIMS We evaluated the efficacy and safety of upadacitinib, an oral selective inhibitor of Janus kinase 1, as induction therapy for ulcerative colitis (UC). METHODS We performed a multicenter, double-blind, phase 2b study of 250 adults with moderately to severely active UC and an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressive agents, and/or biologic therapies. Patients were randomly assigned to groups that received placebo or induction therapy with upadacitinib (7.5 mg, 15 mg, 30 mg, or 45 mg, extended release), once daily for 8 weeks. The primary endpoint was the proportion of participants who achieve clinical remission according to the adapted Mayo score at week 8. No multiplicity adjustments were applied. RESULTS At week 8, 8.5%, 14.3%, 13.5%, and 19.6% of patients receiving 7.5 mg, 15 mg, 30 mg, or 45 mg upadacitinib, respectively, achieved clinical remission compared with none of the patients receiving placebo (P = .052, P = .013, P = .011, and P = .002 compared with placebo, respectively). Endoscopic improvement at week 8, defined as endoscopic subscore of ≤ 1, was achieved in 14.9%, 30.6%, 26.9%, and 35.7% of patients receiving upadacitinib 7.5 mg, 15 mg, 30 mg, or 45 mg, respectively, compared with 2.2% receiving placebo (P = .033, P < .001, P < .001, and P < .001 compared with placebo, respectively). One event of herpes zoster and 1 participant with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily. Increases in serum lipid levels and creatine phosphokinase with upadacitinib were observed. CONCLUSION In a phase 2b trial, 8 weeks of treatment with upadacitinib was more effective than placebo for inducing remission in patients with moderately to severely active UC. (ClinicalTrials.gov, Number: NCT02819635).",2020,One event of herpes zoster and 1 subject with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily.,"['patients with moderately to severely active UC', 'ulcerative colitis (UC', 'Patients With Active Ulcerative Colitis', '250 adults with moderately to severely active UC and an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressive agents, and/or biologic therapies']","['placebo', 'placebo or induction therapy with upadacitinib', 'Upadacitinib']","['endoscopic subscore', 'serum lipid levels and creatine phosphokinase with upadacitinib', 'proportion of subjects who achieve clinical remission according to the Adapted Mayo score', 'deep venous thrombosis', 'Endoscopic improvement', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",250.0,0.463925,One event of herpes zoster and 1 subject with pulmonary embolism and deep venous thrombosis (diagnosed 26 days after treatment discontinuation) were reported in the group that received upadacitinib 45 mg once daily.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre Birmingham, University of Birmingham and University Hospitals Birmingham National Health Service Trust, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panes', 'Affiliation': 'Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanida', 'Affiliation': 'Nagoya City University, Nagoya, Japan.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Siffledeen', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Bidan', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Peter D R', 'Initials': 'PDR', 'LastName': 'Higgins', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan. Electronic address: phiggins@med.umich.edu.'}]",Gastroenterology,['10.1053/j.gastro.2020.02.030'] 3280,28736381,[Efficacy of ACEI in the treatment of hypertension and the effect of secondary prevention in patients complicated with coronary heart disease and stroke].,"OBJECTIVE To investigate the efficacy of ACEI drugs in the treatment of hypertension patients and the effect of two levels of prevention of hypertension complicated with coronary heart disease and stroke. METHDOS 210 cases of hypertension patients in our hospital from January 2012 to December 2015 were randomly divided into experimental group and control group, 105 cases in each group. According to the conventional symptomatic treatment, the experimental group was given lisinopril treatment, while control group was given the captopril treatment. Changes of blood pressure parameters and the level of baPWV in two groups were observed before and after treatment coronary heart disease and stroke, recurrence rate and death rate were compared in these two groups. RESULTS No significant difference of SBP, DBP, PP and baPWV between two groups before treatment (P>0.05). The indexes of the two groups were significantly decreased after 1 months and 3 months, and the level of patients in the experimental group was lower than that of the control group (P<0.05). The recurrence rate in the experimental group was lower than those in the control group (P<0.05). CONCLUSIONS ACEI drugs in the treatment of hypertension can effectively reduce the level of blood pressure, improve arterial elasticity function, reduce the recurrence rate and mortality rate of coronary heart disease and stroke. The effect of antihypertensive and two levels of prevention of hypertension complicated with coronary heart disease and stroke of lisinopril is positive.",2017,"No significant difference of SBP, DBP, PP and baPWV between two groups before treatment (P>0.05).","['hypertension patients', 'patients complicated with coronary heart disease and stroke', '210 cases of hypertension patients in our hospital from January 2012 to December 2015']","['ACEI', 'lisinopril', 'antihypertensive', 'ACEI drugs', 'captopril treatment']","['level of blood pressure, improve arterial elasticity function', 'SBP, DBP, PP and baPWV', 'recurrence rate and mortality rate of coronary heart disease and stroke', 'level of baPWV', 'blood pressure parameters', 'recurrence rate and death rate', 'recurrence rate']","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital (finding)'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0013764'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0176119,"No significant difference of SBP, DBP, PP and baPWV between two groups before treatment (P>0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The first hospital of handan city, Handan 056000, China.E-mail: 775966245@qq.com.'}, {'ForeName': 'Jun-Fa', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ya-Feng', 'Initials': 'YF', 'LastName': 'Hao', 'Affiliation': ''}, {'ForeName': 'Xue-Zhi', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3281,28801294,[Early intervention of BK virus replication promotes stabilization of renal graft function].,"OBJECTIVE To investigate the optimal time window for intervention of BK virus (BKV) replication and its effect on the outcomes of kidney transplant recipients (KTRs). METHODS A retrospective analysis of the clinical data and treatment regimens was conducted among KTRs whose urine BKV load was ≥1.0×10 4 copies/mL following the operation between April, 2000 and April, 2015. KTRs with urine BKV load <1.0×10 4 copies/mL matched for transplantation time served as the control group. RESULTS A total of 54 recipients positive for urine BKV were included in the analysis. According to urine BKV load, the recipients were divided into 3 groups: group A with urine BKV load of 1.0×10 4 -1.0×10 7 copies/mL (n=22), group B with urine BKV load >1.0×10 7 copies/mL (n=24), and group C with plasma BKV load ≥1.0×10 4 copies/mL (n=8); 47 recipients were included in the control group. During the follow-up for 3.2-34.5 months, the urine and plasma BKV load was obviously lowered after intervention in all the 54 BKV-positive recipients (P<0.05). Eighteen (81.82%) of the recipients in group A and 19 (79.17%) in group B showed stable or improved estimated glomerular filtration rate (eGFR) after the intervention; in group C, 4 recipients (50%) showed stable eGFR after the intervention. In the last follow-up, the recipients in groups A and B showed similar eGFR with the control group (P>0.05), but in group C, eGFR was significantly lower than that of the control group (P=0.001). The recipients in group A and the control group had the best allograft outcome with stable or improved eGFR. CONCLUSION Early intervention of BKV replication (urine BKV load ≥1.0×10 4 copies/mL) in KTRs with appropriate immunosuppression reduction can be helpful for stabilizing the allograft function and improving the long-term outcomes.",2017,"In the last follow-up, the recipients in groups A and B showed similar eGFR with the control group (P>0.05), but in group C, eGFR was significantly lower than that of the control group (P=0.001).","['kidney transplant recipients (KTRs', '54 recipients positive for urine BKV']",['BK virus replication'],"['urine BKV load', 'stable eGFR', 'allograft outcome with stable or improved eGFR', 'glomerular filtration rate (eGFR', 'eGFR', 'urine and plasma BKV load', 'renal graft function']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}]","[{'cui': 'C0005670', 'cui_str': 'Polyomavirus hominis 1'}]","[{'cui': 'C0042037'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",47.0,0.0248553,"In the last follow-up, the recipients in groups A and B showed similar eGFR with the control group (P>0.05), but in group C, eGFR was significantly lower than that of the control group (P=0.001).","[{'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Deng', 'Affiliation': 'Department of Organ Transplantation, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China. E-mail: piaoxu445@163.com.'}, {'ForeName': 'Yan-Na', 'Initials': 'YN', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Li-Xin', 'Initials': 'LX', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Shao-Jie', 'Initials': 'SJ', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Chuan-Fu', 'Initials': 'CF', 'LastName': 'DU', 'Affiliation': ''}, {'ForeName': 'Yi-Bin', 'Initials': 'YB', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ru-Min', 'Initials': 'RM', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Gui-Rong', 'Initials': 'GR', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3282,28951366,[Value of 640-slice 3D CT angiography plus 3D printing for improving surgeries for intracranial aneurysms].,"OBJECTIVE To evaluate the value of 640-slice 3D CT angiography (3D-CTA) plus 3D printing for improving the outcomes of surgeries for intracranial aneurysms. METHODS Sixty patients with intracranial aneurysm were randomly divided into trial group (n=30) and control group (n=30). The control group received routine surgery, and the simulation models of the intracranial aneurysm in trial group was printed using a 3D printer using the imaging data from 3D-CTA. Using the simulation model, the surgery was designed and planned before operation (including surgical approaches and placement of clips) and simulation surgery was also conducted. The coincidence rates between preoperative and intraoperative findings of the intracranial aneurysms on 3D-CTA were compared. CT scan was performed at 1 and 3 days after the operation to detect potential cerebral infarction or bleeding associated with the operation; CTA was performed both at the same time and at 3-6 months after the operation to detect stenosis, occlusion and aneurysm clipping. The patients were followed up for 3-6 months to assess the outcomes using Glasgow Outcome Scale (GOS). RESULTS The preoperative 3D-CTA findings were basically consistent with the intraoperative findings in all the 60 patients. Nine patients in the control group and 2 patients in the trial group had short-term adverse operation events; 11 patients in control group and 4 patients in trial group had long-term adverse events; 18 patients in control group and 25 patients in trial group had good neurologic function. The incidences of short-term and long-term adverse events associated with the operation was significantly lower in the trial group than in the control group (χ 2 =5.364, P=0.021; χ 2 =4.841, P=0.028), and the outcomes were significantly better in the trial group than in the control group (χ 2 =4.633, P=0.031). CONCLUSION The simulation model of intracranial aneurysm is helpful to improve the quality of surgery and patients outcomes.",2017,"The incidences of short-term and long-term adverse events associated with the operation was significantly lower in the trial group than in the control group (χ 2 =5.364, P=0.021; χ 2 =4.841, P=0.028), and the outcomes were significantly better in the trial group than in the control group (χ 2 =4.633, P=0.031). ",['Sixty patients with intracranial aneurysm'],"['640-slice 3D CT angiography plus 3D printing', '640-slice 3D CT angiography (3D-CTA) plus 3D printing', 'routine surgery']","['good neurologic function', 'short-term adverse operation events', 'incidences of short-term and long-term adverse events', 'CT scan', 'Glasgow Outcome Scale (GOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007766', 'cui_str': 'Intracranial Aneurysm'}]","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3849992', 'cui_str': '3-Dimensional Printing'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}]",60.0,0.024688,"The incidences of short-term and long-term adverse events associated with the operation was significantly lower in the trial group than in the control group (χ 2 =5.364, P=0.021; χ 2 =4.841, P=0.028), and the outcomes were significantly better in the trial group than in the control group (χ 2 =4.633, P=0.031). ","[{'ForeName': 'Lu-Qiu', 'Initials': 'LQ', 'LastName': 'Zhou', 'Affiliation': 'Postdoctoral Research Station, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.E-mail: 1057824630@qq.com.'}, {'ForeName': 'Ming-Wu', 'Initials': 'MW', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Guo-Chang', 'Initials': 'GC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zhi-Song', 'Initials': 'ZS', 'LastName': 'Jiu', 'Affiliation': ''}, {'ForeName': 'Yun-Xia', 'Initials': 'YX', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3283,32011156,Foreign language learning in older age does not improve memory or intelligence: Evidence from a randomized controlled study.,"Foreign language learning in older age has been proposed as a promising avenue for combatting age-related cognitive decline. We tested this hypothesis in a randomized controlled study in a sample of 160 healthy older participants (aged 65-75 years) who were randomized to 11 weeks of either language learning or relaxation training. Participants in the language learning condition obtained some basic knowledge in the new language (Italian), but between-groups differences in improvements on latent factors of verbal intelligence, spatial intelligence, working memory, item memory, or associative memory were negligible. We argue that this is not due to either poor measurement, low course intensity, or low statistical power, but that basic studies in foreign languages in older age are likely to have no or trivially small effects on cognitive abilities. We place this in the context of the cognitive training and engagement literature and conclude that while foreign language learning may expand the behavioral repertoire, it does little to improve cognitive processing abilities. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Participants in the language learning condition obtained some basic knowledge in the new language (Italian), but between-groups differences in improvements on latent factors of verbal intelligence, spatial intelligence, working memory, item memory, or associative memory were negligible.",['160 healthy older participants (aged 65-75 years'],"['Foreign language learning', 'language learning or relaxation training']","['latent factors of verbal intelligence, spatial intelligence, working memory, item memory, or associative memory']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}]","[{'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",160.0,0.0728105,"Participants in the language learning condition obtained some basic knowledge in the new language (Italian), but between-groups differences in improvements on latent factors of verbal intelligence, spatial intelligence, working memory, item memory, or associative memory were negligible.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Berggren', 'Affiliation': 'Aging Research Center, Karolinska Institute.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center, Karolinska Institute.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brehmer', 'Affiliation': 'Department of Developmental Psychology, Tilburg University.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schmiedek', 'Affiliation': 'Department for Education and Human Development, DIPF | Leibniz Institute for Research and Information in Education.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center, Karolinska Institute.'}]",Psychology and aging,['10.1037/pag0000439'] 3284,30377118,"[Effect of moderate exercise for 30 min at 30 min versus 60 min after dinner on glycemic control in patients with type 2 diabetes: a randomized, crossover, self-controlled study].","OBJECTIVE To compare the effectiveness of moderate exercise for 30 min at 30 min and 60 min after dinner on glycemic control in patients with type 2 diabetes. METHODS This randomized, crossover, self-controlled pilot study was conducted in 15 inactive patients with type 2 diabetes without serious complications or use of exogenous insulin. The participants completed two randomly ordered exercise protocols (brisk walking for 30 min at 30 min or 60 min after dinner on the exercise day) spaced 1 week apart. All the exercise was performed while maintaining a heart rate reserve of 40%. The interstitial glucose level was monitored using a continuous glucose monitor (CGM) for all the participants, who maintained a standardized diet with routine medications. The 2-h postprandial mean glucose, peak glucose, and glucose area under the curve (AUC) were measured. The mean amplitude of glycemic excursions (MAGE) and other plasma glucose fluctuation parameters in 12 h after dinner, including the mean blood glucose (MBG) and the coefficient variation (CV) of glucose, were also calculated. The incidence of nocturnal hypoglycemia was recorded in all the participants. RESULTS The participants had a mean age of 46±11 years with a mean BMI of 25.8±3.1 kg/m 2 and a mean HbA1c of 7.7%. No significant differences were found between postprandial 30 min exercise group and postprandial 60 min exercise group in terms of 2-h postprandial mean glucose, peak glucose, glucose AUC, or in MBG, CV and MAGE during the 12-h period after dinner. No nocturnal hypoglycemia occurred in the participants after exercise at 30 or 60 min after dinner. However, significant reductions in the 2-h postprandial glucose levels were detected after exercise at 60 min after dinner as compared to exercise at 30 min. CONCLUSIONS The timing (30 min vs 60 min after dinner) of moderate exercises for 30 min does not produce significant difference in the improvement of postprandial hyperglycemia in type 2 diabetic patients, and both exercise protocols are safe without a potential risk of hypoglycemia. Nevertheless, exercise at 60 min after dinner can be more effective to lower 2-h postprandial glucose, while exercise at 30 min after dinner might be safer for patients with a high risk of hypoglycemia.",2018,"No significant differences were found between postprandial 30 min exercise group and postprandial 60 min exercise group in terms of 2-h postprandial mean glucose, peak glucose, glucose AUC, or in MBG, CV and MAGE during the 12-h period after dinner.","['15 inactive patients with type 2 diabetes without serious complications or use of exogenous insulin', 'patients with type 2 diabetes', 'participants had a mean age of 46±11 years with a mean BMI of 25.8±3.1 kg/m 2 and a mean HbA1c of 7.7', 'patients with a high risk of hypoglycemia']","['moderate exercise', 'randomly ordered exercise protocols (brisk walking']","['2-h postprandial mean glucose, peak glucose, and glucose area under the curve (AUC', 'postprandial hyperglycemia', 'interstitial glucose level', 'mean amplitude of glycemic excursions (MAGE) and other plasma glucose fluctuation parameters', 'heart rate reserve', 'mean blood glucose (MBG) and the coefficient variation (CV) of glucose', '2-h postprandial glucose levels', 'nocturnal hypoglycemia', '2-h postprandial mean glucose, peak glucose, glucose AUC, or in MBG, CV and MAGE']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}]","[{'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}]",15.0,0.0257046,"No significant differences were found between postprandial 30 min exercise group and postprandial 60 min exercise group in terms of 2-h postprandial mean glucose, peak glucose, glucose AUC, or in MBG, CV and MAGE during the 12-h period after dinner.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, Yancheng First People's Hospital, Yancheng, China, 224005.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The Affiliated Nanjing Hospital of Nanjing Medical University, Nanjing, China, 210012.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, The Affiliated Nanjing Hospital of Nanjing Medical University, Nanjing, China, 210012.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.3969/j.issn.1673-4254.2018.10.03'] 3285,32092310,IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial.,"BACKGROUND & AIMS Refractory gastroesophageal reflux disease (GERD) reduces quality of life and creates significant financial burden on the health care system. Approximately 30% of patients with GERD who receive label-dose proton pump inhibitors (PPIs) still have symptoms. We performed a trial to evaluate the efficacy and safety of IW-3718, a bile acid sequestrant, as an adjunct to PPI therapy. METHODS We performed a multicenter, double-blind, placebo-controlled trial, from March 2016 through April 2017, of 280 patients with confirmed GERD. The patients, stratified by esophagitis status, were randomly assigned (1:1:1:1) to groups given placebo or IW-3718 (500, 1000, or 1500 mg) twice daily, with ongoing label-dose PPI. The primary endpoint was percent change from baseline to week 8 in weekly heartburn severity score. We also analyzed percent change from baseline to week 8 in weekly regurgitation frequency score. RESULTS Mean changes from baseline to week 8 in weekly heartburn severity scores were reductions of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1000 mg group, and 58.0% in the 1500 mg IW-3718 group (dose-response P = .02). The treatment difference was 11.9% between the 1500 mg IW-3718 and placebo groups (P = .04, analysis of covariance). The mean change in weekly regurgitation frequency score from baseline to week 8 in the 1500 mg IW-3718 vs placebo groups was a reduction of 17.5% (95% confidence interval, reductions of 31.4% to 3.6%). The most common adverse event was constipation (in 8.1% of patients receiving IW-3718 and 7.1% of patients receiving placebo). There were no drug-related serious adverse events. CONCLUSIONS In a randomized trial of patients with refractory GERD, adding 1500 mg IW-3718 to label-dose PPIs significantly reduced heartburn symptoms compared with adding placebo. Regurgitation symptoms also decreased. IW-3718 was well tolerated. (ClinicalTrials.gov, Number: NCT02637557).",2020,"Mean changes from baseline to week 8 in weekly heartburn severity scores were reductions of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1000 mg group, and 58.0% in the 1500 mg IW-3718 groups (dose-response P=.02).","['March 2016 through April 2017, of 280 patients with confirmed GERD', 'patients with refractory GERD', 'Patients With Refractory Gastroesophageal Reflux Disease']","['placebo', 'label-dose proton pump inhibitors (PPIs', 'IW-3718, a bile acid sequestrant', 'placebo or IW-3718']","['constipation', 'Regurgitation symptoms', 'tolerated', 'heartburn severity scores', 'mean change in weekly regurgitation frequency score', 'weekly heartburn severity score', 'heartburn symptoms', 'Heartburn Severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C2917337', 'cui_str': 'Bile acid sequestrants'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",280.0,0.336367,"Mean changes from baseline to week 8 in weekly heartburn severity scores were reductions of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1000 mg group, and 58.0% in the 1500 mg IW-3718 groups (dose-response P=.02).","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Vaezi', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address: Michael.vaezi@vumc.org.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Fass', 'Affiliation': 'MetroHealth Medical Center and Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Nimish', 'Initials': 'N', 'LastName': 'Vakil', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Reasner', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mittleman', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'James Z', 'Initials': 'JZ', 'LastName': 'Shao', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Lane', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Gates', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Currie', 'Affiliation': 'Ironwood Pharmaceuticals, Inc, Boston, Massachusetts.'}]",Gastroenterology,['10.1053/j.gastro.2020.02.031'] 3286,3550084,Effectiveness of amantadine in reducing relapses in multiple sclerosis.,Fifty-three patients with multiple sclerosis were assessed in a double-blind multicentre study for the effect of amatadine. The patients were observed in general practices for up to four years. Relapses occurred in 5 of the 24 patients treated with amantadine and in 14 of the 29 placebo-treated patients. Neurological deterioration was not significantly different in the two groups.,1987,Neurological deterioration was not significantly different in the two groups.,['Fifty-three patients with multiple sclerosis'],"['amantadine', 'amatadine']","['Relapses', 'Neurological deterioration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0002403', 'cui_str': 'Amantadine'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",53.0,0.0949758,Neurological deterioration was not significantly different in the two groups.,"[{'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Plaut', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3287,31387119,Examining the Effect of Fish Oil Supplementation in Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery.,"BACKGROUND Intervention studies have shown that long-chain (LC) n-3 PUFA intake can prolong gestation but the dose-time-effect relations remain unresolved. OBJECTIVES We examined the effect on gestation duration of 2 doses of supplemental LC n-3 PUFAs. METHODS We undertook a 3-group parallel randomized controlled trial in areas of China with low (median: 2.1 g/d) and higher (14.3 g/d) fish intake. Unselected women (median: age, 26.2 y; BMI, 20. kg/m2) were randomly assigned at midgestation to take four 0.72-g identical gelatin capsules per day until the last day of the preterm period (<259 days of gestation), when they were asked to stop. Capsules contained fish oil [high fish oil (HFO) group (60% w/w LC n-3 PUFAs)], a 1:3 mixture of fish oil to olive oil [low fish oil (LFO) group (20%)], or olive oil [control (CON) group (0%)], providing 2.0, 0.5, and 0 g/d of LC n-3 PUFAs, respectively. Habitual fish intake was recorded at baseline. Hazard rate ratios (HRRs) for spontaneous delivery <259 days of gestation and <273 days of gestation across groups were estimated by Cox regression. RESULTS Among 5531 women randomly assigned, 92.5% were included in analyses (1706/1825, 1695/1851, and 1717/1855, respectively). The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively]. Inspection of pregnancy survival curves suggested that LC n-3 PUFAs delayed delivery in low fish consumers by 5-10 d and that this effect ceased rapidly after stopping taking the capsules. CONCLUSION This trial could not substantiate that fish oil prevents preterm birth in Chinese women, possibly because statistical power was too low. This trial was registered at clinicaltrials.gov as NCT02770456.",2019,"The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively].","['Chinese women', 'Unselected women (median: age, 26.2 y; BMI, 20. kg/m2', 'areas of China with low (median: 2.1 g/d) and higher (14.3 g/d) fish intake', 'Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery', '5531 women randomly assigned, 92.5% were included in analyses (1706/1825, 1695/1851, and 1717/1855, respectively']","['long-chain (LC) n-3 PUFA intake', 'CON', 'olive oil [control (CON', 'supplemental LC n-3 PUFAs', 'Capsules contained fish oil [high fish oil (HFO', 'fish oil to olive oil [low fish oil (LFO', 'Fish Oil Supplementation']","['Habitual fish intake', 'preterm birth', 'Hazard rate ratios (HRRs', 'mean gestation durations']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0098700', 'cui_str': '5531'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0556216', 'cui_str': 'Fish intake (observable entity)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.715921,"The groups were similar with respect to hazard rates <259 days of gestation [HRR: 1.04 (95% CI: 0.70, 1.53) for LFO compared with CON and 0.90 (95% CI: 0.60, 1.35) for HFO compared with CON], hazard rates <273 days of gestation [HRR: 1.00 (95% CI: 0.86, 1.18) and 0.91 (95% CI: 0.77, 1.07), respectively], and mean gestation durations [differences: 0.2 d (95% CI: -0.5, 0.8) and 0.6 d (95% CI: -0.06, 1.2), respectively].","[{'ForeName': 'Sjurdur F', 'Initials': 'SF', 'LastName': 'Olsen', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Thorhallur I', 'Initials': 'TI', 'LastName': 'Halldorsson', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Strøm', 'Affiliation': 'Centre for Fetal Programming, Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Che', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Nutrition and Food Hygiene Institute, School of Public Health, Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Fengxian', 'Initials': 'F', 'LastName': 'Duan', 'Affiliation': ""Shaanxi Health and Family Planning Commission, Xi'an, China.""}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Weijin', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China.'}]",The Journal of nutrition,['10.1093/jn/nxz153'] 3288,32081514,Are patient educational resources effective at deterring stroke survivors from considering experimental stem cell treatments? A randomized controlled trial.,"OBJECTIVE To evaluate whether online resources developed to educate people about the risks associated with experimental stem cell (SC) treatments influence stroke survivors' attitudes about the safety and effectiveness of these treatments. METHODS Adult stroke survivors who had not previously received SC treatments (N = 112) were recruited from international stroke advocacy/support groups for a prospective, parallel-group randomized controlled trial. Participants indicated whether they were considering SC treatments (yes/no) prior to, immediately following, and 30-days after reading/viewing the International Society for Stem Cell Research booklet or Stem Cell Network video. Participant attitudes regarding the safety, effectiveness, accessibility and affordability of SC treatments were examined on each occasion, and compared to those of a waitlist control group. RESULTS Significantly fewer participants were considering SC treatments immediately after reading the SC research booklet (p =.031), although neither intervention had any impact after 30-days (p >.05). Waitlist and intervention groups reported positive attitudes toward SC treatments at each assessment. CONCLUSIONS Stroke survivor attitudes toward SC treatments were initially influenced by the patient booklet, however these changes were not maintained. PRACTICAL IMPLICATIONS Clinicians are encouraged to initiate discussions about experimental SC treatments during inpatient rehabilitation and to reinforce the risks throughout subsequent care.",2020,"Significantly fewer participants were considering SC treatments immediately after reading the SC research booklet (p =.031), although neither intervention had any impact after 30-days (p >.05).",['Adult stroke survivors who had not previously received SC treatments (N = 112'],[],"['safety, effectiveness, accessibility and affordability of SC treatments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319548', 'cui_str': '112'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0814630', 'cui_str': 'Affordabilities'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",112.0,0.0626666,"Significantly fewer participants were considering SC treatments immediately after reading the SC research booklet (p =.031), although neither intervention had any impact after 30-days (p >.05).","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Unsworth', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Mathias', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia. Electronic address: a1064843@adelaide.edu.au.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Dorstyn', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Koblar', 'Affiliation': 'Stroke Research Programme, University of Adelaide School of Medicine, South Australian Health and Medical Research (SAHMRI), Adelaide, South Australia, Australia; Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.012'] 3289,29502065,[Application of sevoflurane and laryngeal mask in cesarean section in women with heart disease].,"OBJECTIVE To compare the safety of sevoflurane anesthesia with laryngeal mask and tracheal intubation in cesarean section in women with heart disease. METHODS Fifty-two pregnant women with heart diseases undergoing cesarean section were randomized into laryngeal mask (LAM) group and tracheal intubation group. In LAM group, 6% sevoflurane was given at the rate of 6 L/min for induction with a maintenance sevoflurane concentration of 3%. In the intubation group, 1.5 mg/kg propofol and 1 µg/kg remifentanil were injected intravenously, and after achieving D0 with Narcotrend monitoring, 0.9 mg/kg rocuronium was injected and intubation was performed 1 min later. The systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) were recorded in the two groups before anesthesia induction (T 0 ), at intubation or laryngeal mask placement (T 1 ), skin incision (T 2 ), and extubation or laryngeal mask removal (T 3 ). The surgery to fetal birth time, uterine incision to fetal childbirth time, drug discontinuation to awake time, and newborn Apgar scores were also recorded. Sevoflurane consumption and maternal comfort during hospitalization were compared between the two groups. RESULTS In LAM group, HR and MBP at T 1 and T 3 were significantly lower than those in the intubation group (P<0.05). The drug discontinuation to extubation time and to awaken time were significantly shorter in LAM group than in the intubation group (P<0.05), but the operation time and fetal child birth time were comparable between the two groups (P>0.05). The women in LAM group reported better physical and psychological comforts than those in the intubation group (P<0.05). The neonatal Apgar scores and the scores of health education, satisfaction with hospital environment and service were all similar between the two groups (P>0.05). CONCLUSION Sevoflurane anesthesia with laryngeal mask can achieve satisfactory anesthetic effects in cesarean section in women with heart disease.",2018,"The drug discontinuation to extubation time and to awaken time were significantly shorter in LAM group than in the intubation group (P<0.05), but the operation time and fetal child birth time were comparable between the two groups (P>0.05).","['women with heart disease', 'Fifty-two pregnant women with heart diseases undergoing cesarean section']","['Sevoflurane anesthesia with laryngeal mask', 'sevoflurane and laryngeal mask', 'LAM', 'sevoflurane', 'sevoflurane anesthesia with laryngeal mask and tracheal intubation', 'rocuronium', 'laryngeal mask (LAM) group and tracheal intubation group', 'propofol and 1 µg/kg remifentanil']","['satisfactory anesthetic effects', 'intubation or laryngeal mask placement (T 1 ), skin incision (T 2 ), and extubation or laryngeal mask removal (T 3 ', 'HR and MBP', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR', 'drug discontinuation to extubation time and to awaken time', 'physical and psychological comforts', 'neonatal Apgar scores and the scores of health education, satisfaction with hospital environment and service', 'Sevoflurane consumption and maternal comfort during hospitalization', 'operation time and fetal child birth time', 'surgery to fetal birth time, uterine incision to fetal childbirth time, drug discontinuation to awake time, and newborn Apgar scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C3179301', 'cui_str': 'Anesthetic Effect'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0662675', 'cui_str': '(18F)MBP'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]",52.0,0.0382419,"The drug discontinuation to extubation time and to awaken time were significantly shorter in LAM group than in the intubation group (P<0.05), but the operation time and fetal child birth time were comparable between the two groups (P>0.05).","[{'ForeName': 'Zhi-Peng', 'Initials': 'ZP', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, China. E-mail: 13570981688@163.com.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Jin-Dong', 'Initials': 'JD', 'LastName': 'Xu', 'Affiliation': ''}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,[] 3290,31874890,Efficacy of a computer-tailored web-based physical activity intervention using Fitbits for older adults: a randomised controlled trial protocol.,"INTRODUCTION Physical activity is an integral part of healthy ageing, yet the majority of older adults 65+ years are not sufficiently active. Web-based physical activity interventions hold much promise to reach older adults. Preliminary evidence suggests that web-based interventions with tailored advice and Fitbits may be well suited for older adults. METHODS AND ANALYSIS This study aims to test the effectiveness of 'Active for Life', a 12-week computer-tailored web-based physical activity intervention using Fitbits for older adults. We will recruit 300 participants who will be randomly assigned to one of three trial arms: (1) web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control. The primary outcome, objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life will be assessed at baseline and week 12. The secondary outcomes of self-reported physical activity, sitting time and sleep will be assessed at baseline, week 6, 12 and 24. Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24. Intention-to-treat linear mixed model analyses will be used to test for group (tailoring only, tailoring +Fitbit, control) differences on changes in the main outcome, MVPA and secondary outcomes. Generalised linear models will be used to compare intervention groups (tailoring only, tailoring +Fitbit) on website usability, participant satisfaction, website usage and intervention fidelity. ETHICS AND DISSEMINATION The study has received ethics approval from the Central Queensland University Human Research Ethics Committee (H16/12-321). Study outcomes will be disseminated through peer-reviewed publications and academic conferences and used to inform improvements and dissemination of a tailored, web-based physical activity intervention for adults 65+ years. TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trials Registry Number: ACTRN12618000646246.",2019,Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24.,"['300 participants who will be randomly assigned to one of three trial arms: (1', 'adults 65+ years', 'older adults', 'reach older adults', 'Australian and New Zealand']","['Web-based physical activity interventions', 'computer-tailored web-based physical activity intervention', 'web-based physical activity intervention with tailored advice only, (2) web-based physical activity intervention with tailored advice and Fitbit or (3) a wait-list control']","['objective moderate to vigorous physical activity (MVPA) and secondary outcomes of objective sedentary behaviour, objective sleep, quality of life, social support, physical function and satisfaction with life', 'Website usability and participant satisfaction', 'self-reported physical activity, sitting time and sleep']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0037438'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",300.0,0.120672,Website usability and participant satisfaction will be assessed at week 12 and website usage and intervention fidelity will be assessed from week 1 to 24.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Alley', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia s.alley@cqu.edu.au.'}, {'ForeName': 'Jannique Gz', 'Initials': 'JG', 'LastName': 'van Uffelen', 'Affiliation': 'Department of Kinesiology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schoeppe', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Parkinson', 'Affiliation': 'School of Nursing, Midwifery and Social Sciences, Central Queensland University, Bundaburg, Queensland, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hunt', 'Affiliation': 'School of Nursing, Midwifery and Social Sciences, Central Queensland University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Power', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Priority Research Centre for Physical Activity and Nutrition, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Schneiders', 'Affiliation': 'School of Health, Medical and Applied Sciences, Central Queensland University, Bundaburg, Queensland, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'School of Health, Medical and Applied Sciences, Appleton Institute, Physical Activity Research Group, CQUniversity, Rockhampton, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033305'] 3291,31874879,Qualitative exploration of women's experiences of intramuscular pethidine or remifentanil patient-controlled analgesia for labour pain.,"OBJECTIVES To explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum. DESIGN Qualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken. SETTING Women recruited to the RESPITE trial from seven UK hospitals. PARTICIPANTS Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview. RESULTS Eight themes emerged which encompassed women's antenatal plans for pain management ( Birth Expectations ) through to their future preferences for pain relief ( Reflections for Future Choices ). Many women who used remifentanil felt it provided effective pain relief ( Effectiveness of Pain Relief ), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea ( Negative Physiological Responses ) and women using remifentanil describing more cognitive effects ( Cognitive Effects ). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out ( Issues with Drug Administration ). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth ( Enabling a Sense of Control ). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ). CONCLUSIONS Qualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups. TRIAL REGISTRATION NUMBER ISRCTN29654603.",2019,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ). ","[""women's experiences of intramuscular"", 'Eighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview', 'patient-controlled analgesia for labour pain', 'pain relief in labour (RESPITE', 'Women recruited to the RESPITE trial from seven UK hospitals']","['pethidine injection', 'remifentanil or pethidine', 'remifentanil', 'pethidine', 'remifentanil intravenous patient controlled analgesia (PCA', 'remifentanil PCA']","['effective pain relief', 'effective pain relief ( Effectiveness of Pain Relief ', 'Infant Behaviour and Breastfeeding ', 'nausea ( Negative Physiological Responses ', 'labour pain and infant feeding behaviours', 'side effects']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",80.0,0.0602575,"There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups ( Impact on Infant Behaviour and Breastfeeding ). ","[{'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK VLMoran@uclan.ac.uk.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Storey', 'Affiliation': 'College of Health and Wellbeing, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Beeson', 'Affiliation': 'Birmingham Clinical Trials Unit, The University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'MacArthur', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Centre for Urgent and Emergency Care Research, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032203'] 3292,31874882,Efficacy of periacetabular osteotomy followed by progressive resistance training compared to progressive resistance training as non-surgical treatment in patients with hip dysplasia (PreserveHip) - a protocol for a randomised controlled trial.,"INTRODUCTION Periacetabular osteotomy (PAO) is an established treatment for adolescent and adult patients with hip dysplasia. However, the efficacy of PAO has not been tested against another surgical intervention or conservative treatment in a randomised controlled trial before. We suggest that progressive resistance training (PRT) could be an alternative to PAO. The primary aim of this trial is therefore to examine the efficacy of PAO followed by 4 months of usual care followed by 8 months of PRT compared to 12 months of solely PRT in patients with hip dysplasia eligible for PAO in terms of patient-reported pain measured by The Copenhagen Hip and Groin Outcome Score (HAGOS). METHODS AND ANALYSIS This trial is a single-blinded multicentre randomised controlled clinical trial, where patients with hip dysplasia, who are eligible for PAO, will be randomised to either PAO followed by usual care and PRT or PRT only. Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT. The key secondary outcomes are the other subscales of the HAGOS, adverse and serious adverse events, usage of painkillers (yes/no) and type of analgesics. Based on the sample size calculation, the trial needs to include 96 patients. ETHICS AND DISSEMINATION The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-234-18) and by the Danish Data Protection Agency (Journal No 1-16-02-120-19). The trial is also approved by The Regional Committee for Medical and Health Research Ethics, Region South-East Norway (Ref. 2018/1603). All results from this trial will be published in international peer-reviewed scientific journals regardless of whether the results are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER NCT03941171.",2019,"Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT.","['patients with hip dysplasia, who are eligible for PAO', '96 patients', 'patients with hip dysplasia eligible for PAO', 'patients with hip dysplasia (PreserveHip', 'adolescent and adult patients with hip dysplasia']","['periacetabular osteotomy followed by progressive resistance training', 'Periacetabular osteotomy (PAO', 'PAO', 'progressive resistance training (PRT', 'progressive resistance training']","['subscales of the HAGOS, adverse and serious adverse events, usage of painkillers (yes/no) and type of analgesics', 'Danish Data Protection Agency', 'patient-reported pain, measured on the subscale pain on the HAGOS questionnaire', 'Copenhagen Hip and Groin Outcome Score (HAGOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328407', 'cui_str': 'Hip Dysplasia'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",96.0,0.202605,"Primary outcome is patient-reported pain, measured on the subscale pain on the HAGOS questionnaire 12 months after initiation of PAO or PRT.","[{'ForeName': 'Lisa Cecilie Urup', 'Initials': 'LCU', 'LastName': 'Reimer', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark lisareimer@clin.au.dk.'}, {'ForeName': 'Stig Storgaard', 'Initials': 'SS', 'LastName': 'Jakobsen', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mortensen', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Public Health - Sport, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie Sandell', 'Initials': 'JS', 'LastName': 'Jacobsen', 'Affiliation': 'Physiotherapy & Research Centre for Health and Welfare Technology, Programme for Rehabilitation, VIA University College, Aarhus, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Soballe', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Bere', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'May Arna', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Mechlenburg', 'Affiliation': 'Orthopedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-032782'] 3293,3543347,Towards no incisional hernias: lateral paramedian versus midline incisions.,"A prospective randomized controlled clinical trial is reported which compares midline with lateral paramedian incisions in relation to the development of incisional hernias at one year. Of 431 patients randomized, 329 were available for assessment one year later. Two patients suffered burst abdomen, both being in the lateral paramedian group. Twenty-two incisional hernias occurred, 2 in the lateral paramedian group and 20 in the midline group (P less than 0.001). Of the two types of incision, the lateral paramedian incision takes longer to perform, requires a longer incision, rarely results in dehiscence, and does confer protection against incisional hernia.",1986,"Twenty-two incisional hernias occurred, 2 in the lateral paramedian group and 20 in the midline group (P less than 0.001).","['431 patients randomized, 329 were available for assessment one year later']",[],['incisional hernias'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",[],[],431.0,0.0328553,"Twenty-two incisional hernias occurred, 2 in the lateral paramedian group and 20 in the midline group (P less than 0.001).","[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Ausobsky', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pollock', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3294,31815649,Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT.,"BACKGROUND To evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs. METHODS Patients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests. RESULTS Data from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients. CONCLUSIONS Upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA. TRIAL REGISTRATION Clinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.",2019,"Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12.","['patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs', '661 patients were analysed', 'patients with RA who had an inadequate response to csDMARDs']","['placebo', 'upadacitinib 15\u2009mg and 30\u2009mg or placebo']","['FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS', 'Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue', 'differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT', 'global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability', 'PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS', 'improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",661.0,0.164941,"Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Tundia', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. namita.tundia@abbvie.com.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Camp', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Ganguli', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Fuldeore', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Goldschmidt', 'Affiliation': 'Analysis Group, Inc., New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-2037-1'] 3295,3537288,Does dimethicone increase the efficacy of antacids in the treatment of reflux oesophagitis?,"Dimethicone is a common additive to antacids, although its value in the treatment of reflux oesophagitis is unproven. Its efficacy was assessed by comparing the effect of a dimethicone-containing antacid gel (Asilone Gel) with a simple antacid gel in a double-blind trial in 45 patients with reflux oesophagitis. Thirty-eight patients completed the eight-week course of therapy. Antacid therapy alone resulted in a significant improvement of both symptoms and oesophagitis in gastro-oesophageal reflux. The inclusion of dimethicone in the antacid gel preparation did not confer any benefit in terms of symptomatic assessment but did confer a small advantage with regard to objective markers of oesophageal inflammation, suggesting that a dimethicone-containing antacid is of value in the treatment of symptomatic gastro-oesophageal reflux.",1986,"The inclusion of dimethicone in the antacid gel preparation did not confer any benefit in terms of symptomatic assessment but did confer a small advantage with regard to objective markers of oesophageal inflammation, suggesting that a dimethicone-containing antacid is of value in the treatment of symptomatic gastro-oesophageal reflux.",['45 patients with reflux oesophagitis'],"['Antacid therapy', 'antacids', 'Dimethicone', 'dimethicone-containing antacid gel (Asilone Gel) with a simple antacid gel']",['symptoms and oesophagitis in gastro-oesophageal reflux'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}]","[{'cui': 'C1096697', 'cui_str': 'Antacid therapy'}, {'cui': 'C1113707', 'cui_str': 'dimeticone'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003138', 'cui_str': 'Alkalinizing Agents'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0052507', 'cui_str': 'Asilone'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}]",45.0,0.0322756,"The inclusion of dimethicone in the antacid gel preparation did not confer any benefit in terms of symptomatic assessment but did confer a small advantage with regard to objective markers of oesophageal inflammation, suggesting that a dimethicone-containing antacid is of value in the treatment of symptomatic gastro-oesophageal reflux.","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Ogilvie', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3296,32088668,Efficacy of Live Versus Recorded Harp Music in Reducing Preoperative Stress and Fear Related to Minor Surgery: A Pilot Study.,"Context Before surgery, people can become concerned about risks that may arise, experiencing fear and stress. It is possible to implement nonpharmacological interventions to reduce fear and preoperative stress using expressive arts, including music therapy. Objective The aim of this study was to assess the effectiveness of live harp music and compare it with that of recorded harp music in reducing preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR). Design The study was a pilot study, with a quasi-experimental design. Setting The study took place in a surgery unit's clinic, held weekly, in a teaching hospital in Milan, Italy. Participants Participants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group. No one dropped out of the study. Intervention The intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention. The research team had defined a musical protocol based on the theoretical principles of harp therapy. Outcome Measures Before and after the musical intervention, the research team investigated each patient's level of fear and stress, using the same self-evaluation questionnaire (HR) and blood pressure (BP). Results Of the 46 participants, 46% were male, and 54% were female. Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups. The live harp music was more effective in reducing HR (P = .001) and diastolic BP (P = .007), than was recorded harp music, with P = .151 and P = .164, respectively. Based on the results, the research team determined that a randomized controlled trial (RCT) would require 90 patients for both the intervention and control groups. Conclusions Harp therapy brought benefits by significantly reducing fear and stress and HR and BP. It would be useful to perform a multicenter RCT to confirm these results.",2020,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"['46 participants, 46% were male, and 54% were female', 'Participants\n\n\nParticipants were 46 people undergoing day surgery, divided into 2 groups: 24 in the intervention group and 22 in the control group']","['intervention group listened to live harp music and the control group listened to recorded harp music, immediately before a surgical intervention', 'musical intervention', 'recorded harp music', 'live harp music', 'Live Versus Recorded Harp Music']","['diastolic BP', 'preoperative stress and fear and changes in blood pressure (BP) and heart rate (HR', 'Preoperative Stress and Fear Related to Minor Surgery', 'fear and stress and HR and BP', 'self-evaluation questionnaire (HR) and blood pressure (BP', 'Fear values']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgery'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",46.0,0.0333677,Fear values were reduced significantly and in equal measure in the intervention (P = .001) and control (P = .0001) groups.,"[{'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Gelatti', 'Affiliation': ''}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Viganò', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Borsani', 'Affiliation': ''}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Conistabile', 'Affiliation': ''}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Bonetti', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 3297,31977076,The Effect of Orally Administered Dronabinol on Optic Nerve Head Blood Flow in Healthy Subjects-A Randomized Clinical Trial.,"It has been hypothesized that besides its intraocular pressure (IOP) lowering potential, tetrahydrocannabinol (THC) may also improve ocular hemodynamics. The aim of the present study was to investigate whether single oral administration of dronabinol, a synthetic THC, alters optic nerve head blood flow (ONHBF) and its regulation in healthy subjects. The study was carried out in a randomized, placebo-controlled, double-masked, two-way crossover design in 24 healthy subjects. For each study participant, 2 study days were scheduled, on which they either received capsules containing 5 mg dronabinol or placebo. ONHBF was measured with laser Doppler flowmetry at rest and while the study participants performed isometric exercise for 6 minutes to increase mean arterial blood pressure (MAP). This was repeated 1 hour after drug intake. Ocular perfusion pressure (OPP) was calculated as 2/3MAP-IOP. Dronabinol was well tolerated and no cannabinoid-related psychoactive effects were reported. Neither administration of dronabinol nor placebo had an effect on IOP, MAP, or OPP. In contrast, dronabinol significantly increased ONHBF at rest by 9.5 ± 8.1%, whereas placebo did not show a change in ONHBF (0.3 ± 7.4% vs. baseline, P < 0.001 between study days). Dronabinol did not alter the autoregulatory response of ONHBF to isometric exercise. In conclusion, the present data indicate that low-dose dronabinol increases ONHBF in healthy subjects without affecting IOP, OPP, or inducing psychoactive side effects. In addition, dronabinol does not alter the autoregulatory response of ONHBF to an experimental increase in OPP. Further studies are needed to investigate whether this effect can also be observed in patients with glaucoma.",2020,"Neither administration of dronabinol nor placebo had an effect on IOP, MAP or OPP.","['healthy subjects', 'glaucoma patients', 'twenty-four healthy subjects']","['dronabinol', 'isometric exercise', 'Dronabinol', 'placebo', 'dronabinol nor placebo', 'dronabinol or placebo', 'dronabinol, a synthetic THC']","['autoregulatory response of ONHBF to isometric exercise', 'OPP', 'Ocular perfusion pressure (OPP', 'intraocular pressure (IOP) lowering potential, tetrahydrocannabinol (THC', 'ONHBF', 'IOP, MAP or OPP', 'autoregulatory response of ONHBF', 'tolerated and no cannabinoid-related psychoactive effects', 'mean arterial blood pressure (MAP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0202349', 'cui_str': 'Cannabinoids measurement (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",24.0,0.204918,"Neither administration of dronabinol nor placebo had an effect on IOP, MAP or OPP.","[{'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Hommer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kallab', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Szegedi', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Puchner', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Stjepanek', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Werkmeister', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marihan', 'Initials': 'M', 'LastName': 'Abensperg-Traun', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Garhöfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Schmidl', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1797'] 3298,3531514,Trial of (+)-cyanidanol-3 in patients with hepatitis B chronic liver disease.,"A double-blind controlled trial of 12 months' treatment with (+)-cyanidanol-3 was carried out in 26 patients with chronic hepatitis B liver disease. Treatment did not improve liver blood tests nor histological appearances of the liver, but there was a trend towards reduction of serum titres of hepatitis B surface antigen.",1986,"Treatment did not improve liver blood tests nor histological appearances of the liver, but there was a trend towards reduction of serum titres of hepatitis B surface antigen.","['patients with hepatitis B chronic liver disease', '26 patients with chronic hepatitis B liver disease']",['cyanidanol-3'],"['liver blood tests nor histological appearances of the liver', 'serum titres of hepatitis B surface antigen']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]","[{'cui': 'C0010504', 'cui_str': 'Cyanidanol-3'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}]",26.0,0.0444433,"Treatment did not improve liver blood tests nor histological appearances of the liver, but there was a trend towards reduction of serum titres of hepatitis B surface antigen.","[{'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Keeling', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Viola', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Marigold', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Macartney', 'Affiliation': ''}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Paradinas', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Murray-Lyon', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3299,3418660,P6 acupressure reduces morning sickness.,"A prospective study was designed to test the efficacy of pressure at the P6 (Neiguan) acupuncture point, in preventing morning sickness. Three groups of patients in early pregnancy recorded the severity and frequency of sickness over a period of 4 consecutive days following daily pressure at P6 point, pressure at a point near the right elbow and with no treatment. Troublesome sickness was significantly less in both the genuine (23/119) and dummy (41/112) pressure groups as compared with the control series (67/119). When the data are adversely 'weighted' to compensate for the lower incidence of fully completed returns in the active treatment groups, only the P6 group show a significant reduction in sickness. No side effects occurred in either group and while anticipation of benefit may offer a partial explanation for the findings, pressure at the Neiguan point appears to have a specific therapeutic effect.",1988,Troublesome sickness was significantly less in both the genuine (23/119) and dummy (41/112) pressure groups as compared with the control series (67/119).,[],"['P6 acupressure', 'P6 (Neiguan) acupuncture']","['severity and frequency of sickness', 'sickness', 'side effects', 'Troublesome sickness']",[],"[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0150481,Troublesome sickness was significantly less in both the genuine (23/119) and dummy (41/112) pressure groups as compared with the control series (67/119).,"[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Dundee', 'Affiliation': ""Department of Anaesthetics, Queen's University, Belfast.""}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Sourial', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Ghaly', 'Affiliation': ''}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Bell', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3300,3346865,Are we using the correct dose of metronidazole in colorectal surgery?,"In a series of 20 patients undergoing elective colorectal surgery, 10 received an infusion of metronidazole 500 mg and 10 an infusion of 1500 mg commencing at the induction of anaesthesia. The concentrations of metronidazole in the plasma, rectus muscle and colon of the two groups during the course of the operation were compared. In those patients who received 1500 mg, the plasma and tissue concentrations were all well above the minimum inhibitory concentration (MIC) of metronidazole against Bacteroides fragilis. In those patients who received 500 mg, serum and tissue concentrations were at or only just above the MIC. It may be that 1500 mg would be a more effective dose of metronidazole for prophylactic use in colorectal surgery.",1988,"In those patients who received 1500 mg, the plasma and tissue concentrations were all well above the minimum inhibitory concentration (MIC) of metronidazole against Bacteroides fragilis.",['20 patients undergoing elective colorectal surgery'],['metronidazole'],"['concentrations of metronidazole in the plasma, rectus muscle and colon', 'serum and tissue concentrations', 'plasma and tissue concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0448311', 'cui_str': 'Rectus eye muscle structure (body structure)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",20.0,0.0187416,"In those patients who received 1500 mg, the plasma and tissue concentrations were all well above the minimum inhibitory concentration (MIC) of metronidazole against Bacteroides fragilis.","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Hobbiss', 'Affiliation': 'University Hospital of South Manchester.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Carr', 'Affiliation': ''}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Schofield', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3301,3357154,Treatment of urethral stricture disease by internal urethrotomy followed by intermittent 'low-friction' self-catheterization: preliminary communication.,The aim of this study was to determine whether the natural course of urethral stricture disease could be modified following urethrotomy by teaching patients intermittent self-catheterization. Preliminary results in 42 patients show that postoperative urine flow rates can be maintained if this method of 'low-friction' catheterization is adopted. The technique has been well received by an elderly group of patients and can be recommended for wider use.,1988,Preliminary results in 42 patients show that postoperative urine flow rates can be maintained if this method of 'low-friction' catheterization is adopted.,['42 patients'],"['urethrotomy by teaching patients intermittent self-catheterization', ""internal urethrotomy followed by intermittent 'low-friction' self-catheterization""]","['urethral stricture disease', 'postoperative urine flow rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0194550', 'cui_str': 'Incision of urethra (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0565436', 'cui_str': 'Internal urethrotomy (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0556839', 'cui_str': 'Physiotherapeutic frictions'}]","[{'cui': 'C4551691', 'cui_str': 'Urethral stricture (disorder)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042037'}]",42.0,0.0158331,Preliminary results in 42 patients show that postoperative urine flow rates can be maintained if this method of 'low-friction' catheterization is adopted.,"[{'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Lawrence', 'Affiliation': 'Urology Department, City Hospital, Nottingham.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'MacDonagh', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3302,32086674,Evaluation on Efficacy of Psychological and Behavioral Intercession and Its Implications on People with Schizophrenia: A Novel Approach.,"OBJECTIVE To examine and evaluate the efficacy of the spectrum of psychological and behavioral intercession as a novel treatment regime to address the necessity of Schizophrenia affected patients. METHOD A sum of 148 individuals with the first episode of Schizophrenia enrolled in the trial. Patients admitted in our medium-sized hospital with symptoms of schizophrenia were scrutinized carefully and selected for the intercession trial. Total selected individuals were bifurcated into two groups based on guidelines prescribed in the intervention model. Control group or standard care group (SCG) was treated with usual medications and nursing measures of psychiatry practices. Experimental Group (EG) was conferred with enriched psychological strategy and behavioral modules to tackle and satisfy their specific needs. Various methods such as positive and negative syndrome scale (PANSS), several disability screening schedule (SDGSS), satisfaction with life scale (SWLS), global assessment scale (GAS) and finally rate of recurrence of disease were evaluated and analyzed. RESULTS Efficacy of psychological and behavioral intercession on psychotic domine is proved to be effective, and a novel strategy and it is significantly reducing positive and negative psychological symptoms in the experimental group was observed attributing to the intercession. Moreover, a drastic attenuation in the rate of recurrence of disease was supporting a long term efficiency of intercession. CONCLUSION Conducting intervention on psychological and behavioral approach has explored novel treatment outcomes, targeted schizophrenia patients effectively.",2020,"Moreover, a drastic attenuation in the rate of recurrence of disease was supporting a long term efficiency of intercession. ","['People with Schizophrenia', 'Schizophrenia affected patients', '148 individuals with the first episode of Schizophrenia enrolled in the trial', 'Total selected individuals', 'Patients admitted in our medium-sized hospital with symptoms of schizophrenia']","['psychological and behavioral intercession', 'Psychological and Behavioral Intercession', 'Control group or standard care group (SCG']","['positive and negative psychological symptoms', 'positive and negative syndrome scale (PANSS), several disability screening schedule (SDGSS), satisfaction with life scale (SWLS), global assessment scale (GAS) and finally rate of recurrence of disease']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn Sodium'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",148.0,0.0140443,"Moreover, a drastic attenuation in the rate of recurrence of disease was supporting a long term efficiency of intercession. ","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Medical Surgical Department, College of Nursing, King Saud University, P.O. Box 642, Riyadh, 11421, Saudi Arabia.'}, {'ForeName': 'May Mohammed', 'Initials': 'MM', 'LastName': 'Alrashed', 'Affiliation': 'College of Nursing, King Saud University, P.O. Box 642, Riyadh, 11421, Saudi Arabia.'}, {'ForeName': 'Abdual Rahman', 'Initials': 'AR', 'LastName': 'Al-Shehri', 'Affiliation': 'Medical Surgical Department, College of Nursing, King Saud University, Riyadh, 11433, Saudi Arabia.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'BangShang', 'Affiliation': 'Center of Mental Hospital, 40100, Padung Road, Tambon Mueang, Khon Kaen, Jhianing, Thailand. dhd.ksu@gmail.com.'}]",Community mental health journal,['10.1007/s10597-020-00589-5'] 3303,31727428,Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.,"PURPOSE To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN Unmasked multicenter randomized clinical trial. PARTICIPANTS Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group. METHODS Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications. RESULTS The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). CONCLUSIONS There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures.",2020,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"['Patients were enrolled at 16 clinical centers', 'Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group']","['tube shunt surgery', 'tube shunt (350-mm 2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes', 'Trabeculectomy with MMC', 'Primary Tube Versus Trabeculectomy (PTVT']","['Serious complications requiring reoperation or producing loss of 2 or more Snellen lines', 'Mean ± standard deviation IOP', 'cumulative probability of failure', 'rate of surgical failure', 'number of glaucoma medications', 'rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision', 'IOP, glaucoma medical therapy, visual acuity, and surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303409', 'cui_str': '117-In'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",242.0,0.165416,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kin Sheng', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'St. Thomas Hospital, London, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': ""Queen Mary's Hospital, Sidcup, United Kingdom.""}, {'ForeName': 'Iqbal I K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brandt', 'Affiliation': 'Department of Ophthalmology, University of California, Davis, Sacramento, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.10.002'] 3304,31283920,Patient-Level Trajectories and Outcomes After Low-Dose CT Screening in the National Lung Screening Trial.,"BACKGROUND Shared decision-making is an essential element of low-dose CT (LDCT) screening for lung cancer. Understanding patient-level outcomes from the National Lung Screening Trial (NLST) is critical to effectively communicate risks and benefits of screening to patients. METHODS We performed a secondary analysis of data collected in the NLST. We determined outcomes of each LDCT scan performed in the NLST (downstream evaluation, complications, lung cancer diagnoses), and compared outcomes at the test level with outcomes calculated at the patient level for those randomized to LDCT screening. To assess the impact of COPD on patient outcomes, we compared outcomes among patients with and without COPD. RESULTS Of 75,138 LDCT scans, 14.2% led to a diagnostic study and 1.5% to an invasive procedure, with 0.3% of LDCT scans resulting in a procedure-related complication and 0.1% in a serious complication. Among 24,453 patients who underwent LDCT screening, 30.5% underwent a diagnostic study and 4.2% an invasive procedure, with 0.9% of screened patients experiencing a procedure-related complication and 0.3% a serious complication. Patients with COPD (defined by self-report) were more likely to need a diagnostic study (adjusted OR [aOR], 1.29; P < .01) and an invasive procedure (aOR, 1.41; P < .01) and more likely to experience a complication (aOR, 1.83; P < .01) and a serious complication (aOR, 1.78; P = .01). Patients with COPD also were more likely to be diagnosed with lung cancer (aOR, 1.43; P < .01). CONCLUSIONS We provide important patient-level data from the NLST that can be used to guide shared decision-making. The risk-to-benefit ratio of screening may vary significantly in some patients, such as those with COPD, in whom both risks and benefits of screening may be increased.",2019,"Patients with COPD also were more likely to be diagnosed with lung cancer (aOR 1.43, p<0.01). ","['patients with and without COPD', '24,453 patients who underwent']","['computed tomography (LDCT) screening', 'LDCT screening']","['invasive procedure', 'serious complication', 'diagnosed with lung cancer', 'NLST (downstream evaluation, complications, lung cancer diagnoses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.0926638,"Patients with COPD also were more likely to be diagnosed with lung cancer (aOR 1.43, p<0.01). ","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Iaccarino', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, Boston, MA. Electronic address: jmi@bu.edu.'}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Silvestri', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, Boston, MA; Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA.'}]",Chest,['10.1016/j.chest.2019.06.016'] 3305,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein. METHODS We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10 viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen. FINDINGS Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination. INTERPRETATION Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings. FUNDING Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1'] 3306,31377477,Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer.,"BACKGROUND Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel significantly increased the pathologic complete response (pCR) rate compared with the anti-human epidermal growth factor receptor 2 (HER2) agent alone plus paclitaxel. The event-free survival (EFS) and overall survival (OS) by the treatment arms L + T vs. T and L vs. T and the relationship between pCR and EFS/OS both in the whole study population and according to hormone receptor-negative and hormone receptor-positive cohorts after a median follow-up of 6.7 years were assessed. PATIENTS AND METHODS Four hundred fifty-five patients with HER2-positive early breast cancer randomly received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. After surgery, patients received 3 cycles of fluorouracil, epirubicin and cyclophosphamide. The primary end-point was pCR (ypT0/is; for current analysis, it is ypT0/is ypN0), and the secondary end-points were EFS and OS. RESULTS Six-year EFS rates were 67%, 67% and 74% with L, T and L + T, respectively (L vs T: hazard ratio [HR], 0.98 [95% confidence interval {CI}, 0.64-1.51; P = .93]; L + T vs T: HR, 0.81 [95% CI, 0.52-1.26; P = .35]). Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85 [95% CI, 0.49-1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41-1.27; P = .26]). In landmark analyses, patients with a pCR had a significantly higher 6-year EFS (77% and 65%) and OS (89% and 77%) compared with those without a pCR for both overall and the hormone receptor-negative cohort. CONCLUSION Achieving a pCR is important in HER2-positive disease and translates into better long-term outcome with regard to EFS and OS.",2019,"Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85","['patients with HER2-positive primary breast cancer', 'Four hundred fifty-five\xa0patients with HER2-positive early breast cancer']","['L 1000\xa0mg/day plus T', 'Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel', 'paclitaxel', 'fluorouracil, epirubicin and cyclophosphamide', 'HER2 treatment combined with paclitaxel']","['Survival outcomes', '6-year EFS', 'Six-Year OS rates', 'event-free survival (EFS) and overall survival (OS', 'pathologic complete response (pCR) rate', 'OS', 'Six-year EFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.35396,"Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University of Ulm, Breast Center, Ulm, Germany. Electronic address: jens.huober@uniklinik-ulm.de.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': 'Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, United Kingdom.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Executive Vice President, Research & Development Oncology, AstraZeneca, United Kingdom.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Institut Jules Bordet and Breast European Adjuvant Study Team, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Head of Breast Cancer Center, Department of Gynecology, Gynecologic Oncology and Obstetrics, HELIOS Klinikum Berlin, Buch, Germany.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Sarp', 'Affiliation': 'Novartis Pharma AG, Oncology Development Unit, Basel, Switzerland.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Lang', 'Affiliation': 'Istenhegyi Gendiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Royal Marsden Hospital and Institute of Cancer Research, London, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecocq', 'Affiliation': 'Institut Jules Bordet and Breast European Adjuvant Study Team, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'KU Leuven - University of Leuven, Department of General Medical Oncology, University Hospitals Leuven, B-3000, Leuven, Belgium.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Jouannaud', 'Affiliation': 'CRLCC Jean Godinot, Reims, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hackman', 'Affiliation': 'Marien-Hospital Witten, Witten, Germany.'}, {'ForeName': 'Lokanatha', 'Initials': 'L', 'LastName': 'Dasappa', 'Affiliation': 'Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'Hospital Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Toral Pena', 'Affiliation': 'Hospital Torrevieja-Salud, Torrevieja, Spain.'}, {'ForeName': 'Hryhoriy', 'Initials': 'H', 'LastName': 'Adamchuk', 'Affiliation': 'Krivoy Rog City Oncology Centre, Krivoy Rog, Ukraine.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Royal Bournemouth Hospital & Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'de la Pena', 'Affiliation': 'SOLTI - Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach, Offenbach, Germany.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart-Gebhart', 'Affiliation': 'Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; SOLTI Breast Cancer Research Group, Barcelona, Spain.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.038'] 3307,2614768,Preliminary observations on clotting under three hydrocolloid dressings.,"Four patients with five wounds were randomly assigned to treatment with three occlusive dressings: DuoDERM, Restore and Comfeel Ulcus; the dressings were left intact for 24-48 h. When the dressings were removed, it was found that wounds that had been covered with Restore and Comfeel contained coagulated sanguinous material. Two wounds that had been covered with Comfeel and Restore, respectively, were then covered with DuoDERM, while one wound previously covered with DuoDERM was covered with Restore. Either no clotting occurred under DuoDERM or clots may have resolved. Although these preliminary data suggest that DuoDERM gel may have fibrinolytic properties, more extensive and controlled studies are needed to assess the characteristics of this dressing.",1989,"Four patients with five wounds were randomly assigned to treatment with three occlusive dressings: DuoDERM, Restore and Comfeel Ulcus; the dressings were left intact for 24-48 h.",['Four patients with five wounds'],"['occlusive dressings: DuoDERM, Restore and Comfeel Ulcus']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0028791', 'cui_str': 'Occlusive Dressings'}, {'cui': 'C0058802', 'cui_str': 'Duoderm'}, {'cui': 'C0297311', 'cui_str': 'comfeel'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",[],,0.0172474,"Four patients with five wounds were randomly assigned to treatment with three occlusive dressings: DuoDERM, Restore and Comfeel Ulcus; the dressings were left intact for 24-48 h.","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Mulder', 'Affiliation': 'Surgery Department, Veterans Administration Hospital, Denver, Colorado.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3308,3309298,"Experience with nalbuphine, a new opioid analgesic, in acute myocardial infarction.","A total of 141 patients admitted to hospital with a diagnosis of suspected myocardial infarction were randomized to treatment with intravenous diamorphine (71) or nalbuphine (70). Myocardial infarction was subsequently confirmed in 109 patients. Both drugs provided good analgesia. Heart rate, blood pressure, respiratory rate, peak flow and minute volume were measured over a three-hour study period. Except for a slight fall in systolic blood pressure in the nalbuphine-treated group, there were no statistically significant differences between the groups. The nalbuphine-treated group had higher levels of aspartate aminotransferase and hydroxybutyric acid dehydrogenase but not creatine phosphokinase. The haemodynamic outcome and mortality at three months of the two groups were similar. It is concluded that nalbuphine provides effective analgesia coupled with few adverse circulatory or respiratory effects.",1987,The nalbuphine-treated group had higher levels of aspartate aminotransferase and hydroxybutyric acid dehydrogenase but not creatine phosphokinase.,"['109 patients', '141 patients admitted to hospital with a diagnosis of suspected myocardial infarction', 'acute myocardial infarction']","['nalbuphine', 'intravenous diamorphine (71) or nalbuphine (70']","['Heart rate, blood pressure, respiratory rate, peak flow and minute volume', 'systolic blood pressure', 'haemodynamic outcome and mortality', 'aspartate aminotransferase and hydroxybutyric acid dehydrogenase', 'Myocardial infarction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0428679', 'cui_str': 'Minute volume (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0301662', 'cui_str': 'Hydroxybutyric Acids'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",141.0,0.0511262,The nalbuphine-treated group had higher levels of aspartate aminotransferase and hydroxybutyric acid dehydrogenase but not creatine phosphokinase.,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Greenbaum', 'Affiliation': 'Royal Free Hospital and School of Medicine, London.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kaye', 'Affiliation': ''}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Mason', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3309,31813359,Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial.,"Background and Purpose- The aim of this trial was to determine the effect of additional upper limb rehabilitation following botulinum toxin-A for upper limb activity in chronic stroke. Methods- We conducted a multicenter phase III randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis. One hundred forty stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results- In terms of goal attainment, the experimental group scored the same (mean difference, 2 T-score [95% CI, -2 to 7]) as the control group on the Goal Attainment Scale. In terms of upper limb activity, by 3 months the experimental group moved blocks at the same speed (mean difference, 0.00 blocks/s [95% CI, -0.02 to 0.01]) as the control group on the Box and Block Test. There were no differences between groups on any secondary outcome except strength, in favor of the experimental group (mean difference, 1.4 kg [95% CI, 0.2-2.7]). Conclusions- Findings suggest that additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not effective. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: ACTRN12615000616572.",2020,Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention).,"['One hundred forty stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment', 'Chronic Stroke', 'chronic stroke', 'chronic stroke survivors']","['botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises', 'Additional Rehabilitation', 'Botulinum Toxin-A', ' and Purpose', 'botulinum toxin-A', 'Methods']","['upper limb activity', 'Goal Attainment Scale', 'goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test', 'spasticity, range of motion, strength, pain, burden of care, and health-related quality of life']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0579116', 'cui_str': 'Upper limb activities (regime/therapy)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0222045'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.163523,Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention).,"[{'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'From the Department of Neurosciences, Central Clinical School (N.A.L.), Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'Faculty of Health Sciences (Physiotherapy) (L.A.), The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, New South Wales, Australia (C.E.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'College of Nursing and Health Sciences (J.R.), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Faux', 'Affiliation': ""Sacred Heart Rehabilitation Unit, St Vincent's Hospital, Sydney, New South Wales, Australia (S.G.F.).""}, {'ForeName': 'Mithu', 'Initials': 'M', 'LastName': 'Palit', 'Affiliation': 'Alfred Health, Melbourne, Victoria, Australia (N.A.L., M.P.).'}, {'ForeName': 'Senen', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Austin Health, Melbourne, Victoria, Australia (S.G.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Olver', 'Affiliation': 'Epworth Monash Rehabilitation Medicine Research Unit (J.O.), Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research (I.C.), The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation and Aged Care, College of Medicine and Public Health (M.C.), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027602'] 3310,31856691,Cilostazol Versus Aspirin in Ischemic Stroke Patients With High-Risk Cerebral Hemorrhage: Subgroup Analysis of the PICASSO Trial.,"Background and Purpose- Although cilostazol has shown less hemorrhagic events than aspirin, only marginal difference was observed in hemorrhagic stroke events among patients at high risk for cerebral hemorrhage. To identify patients who would most benefit from cilostazol, this study analyzed interactions between treatment and subgroups of the PICASSO trial (Prevention of Cardiovascular Events in Asian Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage). Methods- Ischemic stroke patients with a previous intracerebral hemorrhage or multiple microbleeds were randomized to treatment with cilostazol or aspirin and followed up for a mean 1.8 years. Efficacy, defined as the composite of any stroke, myocardial infarction, and vascular death, and safety, defined as the incidence of hemorrhagic stroke, were analyzed in the 2 groups. Interactions between treatment and age, sex, presence of hypertension and diabetes mellitus, index of high-risk cerebral hemorrhage, and white matter lesion burden were analyzed for primary and key secondary outcomes. Changes in vital signs and laboratory results were compared in the 2 groups. Results- Among all 1534 patients enrolled, a significant interaction between treatment group and index of high risk for cerebral hemorrhage on hemorrhagic stroke ( P for interaction, 0.03) was observed. Hemorrhagic stroke was less frequent in the cilostazol than in the aspirin group in patients with multiple microbleeds (1 versus 13 events; hazard ratio, 0.08 [95% CI, 0.01-0.61]; P =0.01). A marginal interaction between treatment group and white matter change on any stroke ( P for interaction, 0.08) was observed. Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes. Heart rate and HDL (high-density lipoprotein) cholesterol level were significantly higher in the cilostazol group than in the aspirin group at follow-up. Conclusions- Cilostazol may be more beneficial for ischemic stroke patients with multiple cerebral microbleeds and before white matter changes are extensive. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01013532.",2020,"Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes.","['With High-Risk Cerebral Hemorrhage', 'Ischemic stroke patients with a previous intracerebral hemorrhage or multiple microbleeds', '1534 patients enrolled', 'Ischemic Stroke Patients', 'Asian Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage', 'patients at high risk for cerebral hemorrhage', 'ischemic stroke patients with multiple cerebral microbleeds']","['Methods', 'cilostazol or aspirin', 'Cilostazol', 'Cilostazol Versus Aspirin', 'cilostazol', 'aspirin', ' and Purpose', 'Conclusions- Cilostazol']","['hemorrhagic stroke events', 'composite of any stroke, myocardial infarction, and vascular death, and safety, defined as the incidence of hemorrhagic stroke', 'Hemorrhagic stroke', 'Heart rate and HDL (high-density lipoprotein) cholesterol level', 'index of high risk for cerebral hemorrhage on hemorrhagic stroke', 'hemorrhagic events']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}]",1534.0,0.0994648,"Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P =0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P =0.03) white matter changes.","[{'ForeName': 'Bum Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea (B.J.K., S.H.H.).'}, {'ForeName': 'Sun U', 'Initials': 'SU', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology (S.U.K., D.-W.K.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': 'Joung-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Hanyang University, Myongji Hospital, Seoul, Korea (J.-H.P.).'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': ""Department of Neurology, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Seoul (Y.-J.K.).""}, {'ForeName': 'Keun-Sik', 'Initials': 'KS', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea (K.-S.H.).'}, {'ForeName': 'Lawrence K S', 'Initials': 'LKS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong (L.K.S.W.).'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Anam Hospital (S.Y.), Korea University, Seoul.'}, {'ForeName': 'Yang-Ha', 'Initials': 'YH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurology, Kyungpook National University Hospital, Daegu, Korea (Y.-H.H.).'}, {'ForeName': 'Ji Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center (J.S.L.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics (J.L.), Korea University, Seoul.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Rha', 'Affiliation': 'Department of Neurology, Inha University Hospital, Incheon, Korea (J.-H.R.).'}, {'ForeName': 'Sung Hyuk', 'Initials': 'SH', 'LastName': 'Heo', 'Affiliation': 'From the Department of Neurology, Kyung Hee University Medical Center, Seoul, Korea (B.J.K., S.H.H.).'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University Hospital, Gwangju, Korea (S.H.A.).'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea (W.-K.S.).'}, {'ForeName': 'Jong-Moo', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Eulji General Hospital, Eulji University, Seoul, Korea (J.-M.P.).'}, {'ForeName': 'Ju-Hun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Sacred Heart Hospital, Hallym University, Seoul, Korea (J.-H.L.).'}, {'ForeName': 'Jee-Hyun', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Ulsan University Hospital, Ulsan University, Korea (J.-H.K.).'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Dongsan Medical Center, Keimyung University, Daegu, Korea (S.-I.S.).'}, {'ForeName': 'Jin-Man', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Ansan Hospital (J.-M.J.), Korea University, Seoul.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Navarro', 'Affiliation': 'Department of Neurology and Psychiatry, University of Santo Tomas Hospital, Manila, Philippines (J.C.N.).'}, {'ForeName': 'Hahn Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Korea (H.Y.K.).'}, {'ForeName': 'Eung-Gyu', 'Initials': 'EG', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea (E.-G.K.).'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kangwon National University Hospital, Chuncheon, Korea (S.K.).'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Neurology, Dong-A University Hospital, Busan, Korea (J.-K.C.).'}, {'ForeName': 'Man-Seok', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Chonnam National University Medical School, Gwangju, Korea (M.-S.P.).'}, {'ForeName': 'Hyo Suk', 'Initials': 'HS', 'LastName': 'Nam', 'Affiliation': 'Department of Neurology, Yonsei University Severance Hospital, Seoul, Korea (H.S.N.).'}, {'ForeName': 'Dong-Wha', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology (S.U.K., D.-W.K.), Asan Medical Center, Ulsan University, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.023855'] 3311,31375462,Variations in Marginal Taste Perception by Body Mass Index Classification: A Randomized Controlled Trial.,"BACKGROUND The propensity to overeat may, in part, be a function of the satisfaction derived from eating. If levels of satisfaction derived from food differ among normal-weight, overweight, and obese adults, the quantification of satisfaction from food may help explain why some people eat more than others. OBJECTIVE To quantify the satisfaction obtained from eating one specific food, chocolate, by measuring taste perception as normal-weight, overweight, and obese participants consumed additional pieces of chocolate. To measure the effect of nutritional information on chocolate consumption. DESIGN Randomized, controlled trial. PARTICIPANTS/SETTING We analyzed data on 290 adults; 161 had a body mass index (BMI) that was considered normal (<25), 78 had a BMI considered overweight (≥25 and <30), and 51 had a BMI considered obese (≥30). INTERVENTION Participants were given samples of chocolate, one at a time, until they chose to stop eating. With each sample, participants were given a questionnaire. Half of the study participants were randomly selected to receive nutritional information (n=150). MAIN OUTCOME MEASURES Perceived taste for each sample. STATISTICAL ANALYSES PERFORMED We used time-series-regression to model perceived taste changes while controlling for participant characteristics. RESULTS Study participants consumed between 2 and 51 pieces of chocolate with a mean of 12.1 pieces. Average taste perception decreased with each piece. We found no significant difference in taste perceptions between normal- and overweight participants. However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02). Also, obese participants reported taste perceptions that declined at a more gradual rate than normal- and overweight participants (P<0.01). Self-reported hunger, prior to the study, affected taste perception, but providing nutritional information did not. CONCLUSIONS Obese participants started with higher levels of perceived taste and also experienced slower rates of decline than did normal-weight and overweight individuals.",2020,"However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02).","['290 adults; 161 had a body mass index (BMI) that was considered normal (<25), 78 had a BMI considered overweight (≥25 and <30), and 51 had a BMI considered obese (≥30']",['nutritional information'],"['initial taste perception', 'Marginal Taste Perception by Body Mass Index Classification', 'gradual rate', 'Average taste perception', 'taste perceptions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2350521', 'cui_str': 'Gustatory Perception'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}]",290.0,0.102231,"However, obese participants had higher levels of initial taste perception than normal- and overweight participants (P=0.02).","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': ''}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Segre', 'Affiliation': ''}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.018'] 3312,31373696,Response to Glucocorticosteroids Predicts Olfactory Outcome After ESS in Chronic Rhinosinusitis.,"OBJECTIVES Olfaction is frequently impaired in chronic rhinosinusitis with nasal polyps (CRSwNP) and often improves after endoscopic sinus surgery (ESS). Data about dynamics of olfactory changes after ESS are lacking, and little information is available concerning whether preoperatively administered glucocorticosteroids predict postoperative olfaction. Therefore, the aim of this study was to examine dynamics of olfaction after ESS in relation to the effect of preoperative administration of glucocorticosteroids in CRSwNP. METHODS This prospective study included 52 CRSwNP patients (30 men, 22 women, mean age 54 ± 14 years) divided into a control group (n = 31) subjected to ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively. Self-ratings of olfaction and olfactory testing using the extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score) were performed. Olfaction was measured preoperatively; after termination of glucocorticosteroid treatment (only treatment group); and 2 weeks, 1 month, and 3 months postoperatively. RESULTS After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%. In addition, improvement in TDI score after steroids and 3 months postoperatively were significantly correlated (r = 0.66, P = 0.01). Patients whose olfaction did not improve after glucocorticosteroids did not benefit from surgery. Regarding postoperative olfactory dynamics, TDI score reached its maximum 1 month postoperatively and decreased again approximately 3 months after surgery. CONCLUSION Glucocorticosteroids improved olfaction in CRSwNP comparable to surgery. In addition, changes in relation to steroids predicted olfactory outcome postoperatively. Regarding the olfactory dynamics, it could be demonstrated that olfactory function increased 1 month after surgery and decreased 3 months postoperatively. LEVEL OF EVIDENCE 2 Laryngoscope, 130:1616-1621, 2020.",2020,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","['52 CRSwNP patients (30 men, 22 women, mean age 54\u2009±\u200914\u2009years) divided into a control group (n = 31) subjected to', 'Chronic Rhinosinusitis', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['ESS without preoperative steroids and a treatment group (n = 21) receiving orally administered glucocorticosteroids preoperatively', 'Glucocorticosteroids', 'glucocorticosteroids', 'endoscopic sinus surgery (ESS']","[""extended Sniffin' Sticks test battery (threshold, discrimination and identification [TDI] score"", 'olfactory function', 'TDI score', 'Olfactory Outcome', 'Olfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037361', 'cui_str': 'Sense of Smell'}]",22.0,0.0370891,"After glucocorticosteroids, TDI score significantly improved in 57% of patients, and olfactory function remained unchanged in 43%.","[{'ForeName': 'Vasyl', 'Initials': 'V', 'LastName': 'Bogdanov', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Walliczek-Dworschak', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Whitcroft', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Basile N', 'Initials': 'BN', 'LastName': 'Landis', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, Technische Universität Dresden, Dresden.'}]",The Laryngoscope,['10.1002/lary.28233'] 3313,32070647,The Feasibility of the Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic in Intracapsular and Extracapsular Hip Fractures.,"BACKGROUND The local anesthetic dosages used in the current literature in regional applications of local anesthetics are frequently high for surgical purposes, and there are no sufficient dosage studies for emergency department (ED) management. OBJECTIVES The aim of this study was to determine the success of lower local anesthetic dosages capable of reducing costs and excessive exposure to drugs in pain control in patients with femoral neck fractures (FNFs) in the ED. METHODS Patients ≥65 years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8 were included in this prospective, interventional study. Patients underwent ultrasound-guided regional femoral block with 5 mL 2% prilocaine. Pain scores before the procedure and at 30 min and 2 h postprocedure were compared with the Friedman test and Wilcoxon test with Bonferroni correction. RESULTS Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled. The initial pain scores of patients with both intra- and extracapsular fractures were 8 (range 8-10). A statistically significant 50% decrease in pain scores was observed in both groups 30 min after the regional block procedure (p < 0.001). A statistically significant 75% decrease in pain scores was observed in both groups 2 h after the regional block procedure (p < 0.001). No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups. CONCLUSIONS The administration of 5 mL 2% prilocaine for pain control in FNFs in elderly patients in the ED can reduce systemic analgesic requirements by establishing effective analgesia in both intracapsular and extracapsular fractures.",2020,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups. ","['Intracapsular and Extracapsular Hip Fractures', 'Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled', 'patients with femoral neck fractures (FNFs', 'elderly patients', 'Patients ≥65\xa0years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8']","['prilocaine', 'Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic', 'ultrasound-guided regional femoral block with 5\xa0mL 2% prilocaine']","['change in 30-min and 2-h pain scores', 'initial pain scores', 'pain scores', 'systemic analgesic requirements', 'Pain scores']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.0603779,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups. ","[{'ForeName': 'Fatih Esad', 'Initials': 'FE', 'LastName': 'Topal', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Yamanoglu', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Karakaya', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Payza', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Pınar Yesim', 'Initials': 'PY', 'LastName': 'Akyol', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Aslan', 'Affiliation': 'Department of Orthopaedics and Traumatology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Aksun', 'Affiliation': 'Department of Anesthesiology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.12.033'] 3314,3116238,Parenteral nutrition via peripheral veins: a feasibility study.,"Twenty patients who had undergone uncomplicated surgery of moderate severity were randomly allocated to two groups (both n = 10) who were fed using a peripheral vein for up to six days. Group I received, each day, a nutrient solution providing 10 grams of nitrogen as Perifusin (E Merck Ltd) and 1400 calories as dextrose and Intralipid (Kabivitrum Ltd) with an osmolality of 490 mosmol/kg. Group II received only 15 grams of nitrogen per day as Perifusin with an osmolality of 376 mosmol/kg. The mean (+/- s.e. mean) nitrogen balance over the study was similar in both groups, in Group I being -1.23 +/- 0.89, and in Group II being -1.05 +/- 1.08 g (P greater than 0.05 Mann-Whitney U test). The nutrient mixture given to Group I resulted in elevated levels of serum 3-hydroxybutyrate and lower levels of serum non-esterified fatty acids. These data suggest that lipolysis and ketogenesis were suppressed. There was no significant difference in serum lactate levels in either group. Venous thrombophlebitis at the infusion site was assessed daily using Maddox's criteria, with a minimal degree of inflammation occurring in either group. This preliminary study suggests that a total parenteral feeding regimen may be designed for peripheral vein infusion. Further studies are indicated.",1987,I resulted in elevated levels of serum 3-hydroxybutyrate and lower levels of serum non-esterified fatty acids.,['Twenty patients who had undergone uncomplicated surgery of moderate severity'],"['nutrient solution providing 10 grams of nitrogen as Perifusin (E Merck Ltd) and 1400 calories as dextrose and Intralipid (Kabivitrum Ltd) with an osmolality of 490 mosmol/kg', 'nutrient mixture given to Group', 'Parenteral nutrition via peripheral veins']","['elevated levels of serum 3-hydroxybutyrate and lower levels of serum non-esterified fatty acids', 'mean) nitrogen balance', 'Venous thrombophlebitis', 'serum lactate levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0699218', 'cui_str': 'Kabivitrum'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0439353', 'cui_str': 'mosmol/kg'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0106006', 'cui_str': '3-Hydroxybutyrate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance (observable entity)'}, {'cui': 'C0040046', 'cui_str': 'Thrombophlebitis'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}]",,0.0228811,I resulted in elevated levels of serum 3-hydroxybutyrate and lower levels of serum non-esterified fatty acids.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Chemical Pathology, London Hospital.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Goode', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Kirk', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sugden', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3315,3039130,Maintenance therapy with unprocessed bran in the prevention of acute anal fissure recurrence.,"The effect of unprocessed bran in a dose of 5 g three times daily and a dose of 2.5 g three times daily for one year on the recurrence rate of anal fissures was studied in a double-blind, placebo-controlled trial in 90 patients with recently healed acute posterior anal fissures. Fifteen patients (16.6%) were withdrawn before the code was broken due to failure to follow the trial protocol for various reasons. Significantly fewer recurrences occurred in patients receiving bran 5 g three times daily (recurrence rate 16%, 95% confidence limits, 4.54 to 36.08) when compared with patients receiving bran 2.5 g three times daily (60%; 38.67 to 78.87) (P less than 0.01) and with patients receiving placebo three times daily (68%; 46.50 to 85.05) (P less than 0.01). No significant difference in recurrences was found between patients on bran 2.5 g and those on placebo.",1987,"Significantly fewer recurrences occurred in patients receiving bran 5 g three times daily (recurrence rate 16%, 95% confidence limits, 4.54 to 36.08) when compared with patients receiving bran 2.5 g three times daily (60%; 38.67 to 78.87) (P less than 0.01) and with patients receiving placebo three times daily (68%; 46.50 to 85.05) (P less than 0.01).",['90 patients with recently healed acute posterior anal fissures'],"['unprocessed bran', 'placebo', 'Maintenance therapy with unprocessed bran']","['acute anal fissure recurrence', 'recurrences', 'recurrence rate of anal fissures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}]","[{'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0349070', 'cui_str': 'Acute anal fissure (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}]",90.0,0.104384,"Significantly fewer recurrences occurred in patients receiving bran 5 g three times daily (recurrence rate 16%, 95% confidence limits, 4.54 to 36.08) when compared with patients receiving bran 2.5 g three times daily (60%; 38.67 to 78.87) (P less than 0.01) and with patients receiving placebo three times daily (68%; 46.50 to 85.05) (P less than 0.01).","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Jensen', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3316,32064971,Extended-cycle versus conventional treatment with a combined oral contraceptive containing ethinylestradiol (30 μg) and levonorgestrel (150 μg) in a randomized controlled trial.,"The objective was to assess efficacy and safety of a combined oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG) in an extended-cycle vs. a conventional-cycle regimen. This first European randomized, active controlled, open, prospective, parallel-group trial was conducted in 48 German gynecological centers. 1,314 healthy, sexually active women aged 18-35 years were randomized. With an unadjusted PI of 0.483 (upper 95% CI: 1.237), the extended-cycle regimen fulfilled the contraceptive efficacy of EE/LNG, the requirements of the European Medicines Agency. The mean total number of bleeding days per year was significantly lower in the extended-cycle vs. the conventional-cycle regimen. Analyses of bleeding patterns showed a reduced total number of bleeding/spotting days per year in the extended-cycle vs. the conventional-cycle regimen. Cycle-associated complaints and AE were comparable in both groups. Both regimens were very well accepted. The extended-cycle regimen of EE/LNG was effective and well tolerated resulting in a lower number of bleeding days and a favorable bleeding pattern compared to the conventional-cycle regimen.",2020,The extended-cycle regimen of EE/LNG was effective and well tolerated resulting in a lower number of bleeding days and a favorable bleeding pattern compared to the conventional-cycle regimen.,"['48 German gynecological centers', '1,314 healthy, sexually active women aged 18-35\u2009years']","['combined oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG', 'combined oral contraceptive containing ethinylestradiol (30\u2009μg) and levonorgestrel', 'EE/LNG']","['mean total number of bleeding days per year', 'Cycle-associated complaints and AE', 'efficacy and safety']","[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1314.0,0.084088,The extended-cycle regimen of EE/LNG was effective and well tolerated resulting in a lower number of bleeding days and a favorable bleeding pattern compared to the conventional-cycle regimen.,"[{'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hadji', 'Affiliation': 'Frankfurter Hormon-und Osteoporosezentrum, Frankfurt am Main, Germany and Philipps-University of Marburg, Marburg, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neulen', 'Affiliation': 'Clinic for Gynaecological Endocrinology and Reproductive Medicine, University of Aachen, Aachen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Schaudig', 'Affiliation': 'Center of Gynaecological Endocrinology, Hormone Hamburg, Hamburg, Germany.'}, {'ForeName': 'Anneliese', 'Initials': 'A', 'LastName': 'Schwenkhagen', 'Affiliation': 'Center of Gynaecological Endocrinology, Hormone Hamburg, Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Grimmbacher', 'Affiliation': 'Clinical Science and Operations, Meda Pharma GmbH and Co. KG (A Mylan Company), Bad Homburg, Germany.'}, {'ForeName': 'Inka', 'Initials': 'I', 'LastName': 'Wiegratz', 'Affiliation': 'VivaNeo Kinderwunschpraxis Frankfurt, Frankfurt am Main, Germany.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1725963'] 3317,32062862,"A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity.","BACKGROUND Pharmacological treatment options for adolescents with obesity are very limited. Glucagon-like-peptide-1 (GLP-1) receptor agonist could be a treatment option for adolescent obesity. OBJECTIVE To investigate the effect of exenatide extended release on body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics as secondary outcomes, and its safety and tolerability in adolescents with obesity. METHODS Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m 2 according to WHO were included. Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly. Oral glucose tolerance tests (OGTT) were conducted at the beginning and end of the intervention. RESULTS Exenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00), % BMI 95th percentile (-2.9%; -5.4, -0.3), weight (-3 kg; -5.8, -0.1), waist circumference (-3.2 cm; -5.8, -0.7), subcutaneous adipose tissue (-552 cm 3 ; -989, -114), 2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1), total cholesterol (11.6 mg/dL; -21.7, -1.5), and BMI (-0.83 kg/m 2 ; -1.68, 0.01) without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo. Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients. CONCLUSIONS Treatment of adolescents with severe obesity with extended-release exenatide is generally well tolerated and leads to a modest reduction in BMI metrics and improvement in glucose tolerance and cholesterol. The study indicates that the treatment provides additional beneficial effects beyond BMI reduction for the patient group.",2020,"RESULTS Exenatide reduced (P < .05)","['adolescents with severe obesity', '30\u2009kg/m 2 according to WHO were included', 'patients (n = 44, 10-18\u2009years, females n = 22) with BMI-SDS\u2009>\u20092.0 or age-adapted-BMI\u2009', 'adolescents with obesity']","['Glucagon-like-peptide-1 (GLP-1) receptor agonist', 'lifestyle intervention', 'placebo', 'exenatide', 'exenatide extended release 2 mg (n = 22) or placebo']","['Safety and tolerability profiles', 'liver fat content', 'waist circumference', '2-hour-glucose during OGTT ', 'body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics', 'total cholesterol', 'BMI metrics', 'BMI', 'safety and tolerability', 'glucose tolerance and cholesterol', 'subcutaneous adipose tissue', 'Oral glucose tolerance tests (OGTT']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}]",22.0,0.3828,"RESULTS Exenatide reduced (P < .05)","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weghuber', 'Affiliation': 'Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Forslund', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ahlström', 'Affiliation': 'Department of Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alderborn', 'Affiliation': 'Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bergström', 'Affiliation': 'Scandinavian CRO, Uppsala, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brunner', 'Affiliation': 'Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadamuro', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ciba', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dahlbom', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heu', 'Affiliation': 'Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hofmann', 'Affiliation': 'Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kristinsson', 'Affiliation': 'Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kullberg', 'Affiliation': 'Department of Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ladinger', 'Affiliation': 'Department of Radiology, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Lagler', 'Affiliation': 'Clinical Research Center Salzburg GmbH, Salzburg, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lidström', 'Affiliation': 'Children Obesity Clinic, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Manell', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Meirik', 'Affiliation': 'Children Obesity Clinic, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mörwald', 'Affiliation': 'Obesity Research Unit, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Roomp', 'Affiliation': 'Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-Belval, Luxembourg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schneider', 'Affiliation': 'Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-Belval, Luxembourg.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vilén', 'Affiliation': 'Children Obesity Clinic, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Widhalm', 'Affiliation': 'Obesity Research Unit, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zsoldos', 'Affiliation': 'Obesity Research Unit, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bergsten', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Pediatric obesity,['10.1111/ijpo.12624'] 3318,30785198,"Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial.","BACKGROUND Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of XELOX versus GEMOX as first-line therapy for advanced BCTs. PATIENTS AND METHODS In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000 mg/m2 on days 1 and 8, and oxaliplatin 100 mg/m2 on day 1) or XELOX (capecitabine 1000 mg/m2, twice daily, on days 1-14 and oxaliplatin 130 mg/m2 on day 1) as first-line treatment, given every 3 weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate. RESULTS In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3 months for the GEMOX group and 5.8 months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was -12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001). CONCLUSION XELOX showed significant noninferiority to GEMOX in terms of 6-month PFS rate. Thus, XELOX could be an alternative first-line treatment of BCTs. TRIAL REGISTRATION This study was registered in ClinicalTrials.gov (number NCT01470443).",2019,"The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001). ","['randomly selected patients with metastatic BCTs to receive', '114 patients randomly received', 'advanced biliary tract cancers']","['Capecitabine plus oxaliplatin (XELOX', 'XELOX', 'oxaliplatin 130', 'GEMOX', 'XELOX versus GEMOX', 'Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin', 'GEMOX (gemcitabine 1000\u2009mg/m2 on days 1 and 8, and oxaliplatin 100\u2009mg/m2 on day 1) or XELOX (capecitabine', 'Meanwhile, gemcitabine plus oxaliplatin (GEMOX']","['frequencies of hospital visits', 'activity and tolerable toxicity', '6-month PFS rate', '6-month PFS rate difference', '6-month progression-free survival (PFS) rate', 'median overall survival', 'median PFS', 'objective response', 'neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4081033', 'cui_str': 'oxaliplatin 100 MG'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",114.0,0.0918181,"The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001). ","[{'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Gyeongsang National University Hospital, Jinju.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Ajou University School of Medicine, Suwon.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Dong-A University School of Medicine, Busan.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Chung-Ang University College of Medicine, Seoul.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': ""Division of Hemato-oncology, Department of Medicine, Seoul St Mary's Hospital, Catholic University, Seoul.""}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Sohn', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Konkuk University Medical Center, Seoul.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Yonsei University College of Medicine, Seoul.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': ""Division of Hemato-oncology, Department of Medicine, Incheon St Mary's Hospital, Catholic University, Incheon.""}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul. Electronic address: oncopark@skku.edu.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hemato-oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul. Electronic address: hoylim@skku.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdz058'] 3319,32072772,A randomized controlled trial examining an exam room poster to prompt communication about weight.,"BACKGROUND Recognition of childhood weight status is important to the adoption of healthy lifestyle behaviours. OBJECTIVES We assessed whether an exam room educational poster addressing weight and healthy lifestyle behaviours was acceptable to parents, prompted parent-provider communication or improved parental weight perception accuracy. METHODS In this multi-site randomized controlled trial, exam rooms were randomized to display the posters (English and Spanish) or not. Children ages 3 to 8 years (N = 965) attending well visits were weighed and roomed per usual clinic protocol. After the visit, parents completed a questionnaire assessing demographics, child weight status perceptions and whether they discussed weight status with provider or were shown growth charts. We used separate logistic regression analyses to examine associations between intervention status and: asking provider about child weight, being shown growth charts, and accuracy of weight perception, adjusting for covariates and clustering by exam room. RESULTS Of the parents who saw the poster, 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%). Parents who saw the poster were more likely to report being shown a growth chart (OR 1.87, 95% 1.06, 3.30) but were not more likely to ask about their child's weight status nor accurately report their child's weight status. CONCLUSIONS An educational exam room poster about healthy weight was well-received by parents and prompted providers to show the child's growth chart but did not prompt parent-initiated conversations about weight status nor improve parental weight perception accuracy.",2020,", 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%).",['Children ages 3 to 8\u2009years (N = 965) attending well visits were weighed and roomed per usual clinic protocol'],[],"['healthy lifestyle behaviours', 'weight status visualization']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",[],"[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",965.0,0.0279247,", 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%).","[{'ForeName': 'Callie L', 'Initials': 'CL', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Janna B', 'Initials': 'JB', 'LastName': 'Howard', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina.'}]",Pediatric obesity,['10.1111/ijpo.12625'] 3320,31838561,"Oral vinorelbine versus intravenous vinorelbine, in combination with epirubicin as first-line chemotherapy in Chinese patients with metastatic breast cancer.","Oral VRL offers easier administration, better quality of life, and cost saving. This study aimed to evaluate the treatment efficacy in terms of tumor response of the two formulations of vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI); and the effect of EPI co-administration on VRL pharmacokinetics (PK) in Chinese patients with metastatic breast cancer (MBC) using a phase 2, open label, randomized trial. Patients were aged 18-70 years, had histologically confirmed MBC, Karnofsky Performance Status ≥ 70%, and life expectancy ≥ 12 weeks. The treatment consisted of 6 cycles of 3 weeks each. VRL dose was: (Oral-VRL) 60 mg/m 2 for cycle 1, 80 mg/m 2 for cycles 2-6, and (IV-VRL) 25 mg/m 2 for cycle 1 and 30 mg/m 2 for cycles 2-6. EPI dose of 75 mg/m 2 was given on day 1 in both arms for all cycles. 133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms. The median age for Oral-VRL and IV-VRL arms was 48.4 and 50.0 years, respectively. Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL. Both treatment arms met the efficacy objective target of at least 31 responses, demonstrating efficacy as first-line treatment for MBC. Similar blood PK profiles, exposures, and VRL clearance were observed between VRL + EPI vs VRL-only modalities for both arms. Oral VRL is comparable to IV VRL and an effective first-line treatment for Chinese patients with MBC. The activity of VRL + EPI combination is unaltered when VRL is given orally at recommended doses.",2020,Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL.,"['Chinese patients with MBC', 'Chinese patients with metastatic breast cancer', 'Chinese patients with metastatic breast cancer (MBC', '133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms', 'Patients were aged 18-70\xa0years, had histologically confirmed MBC, Karnofsky Performance Status ≥\u200970%, and life expectancy\u2009≥\u200912\xa0weeks']","['Oral vinorelbine', 'Oral VRL', 'VRL dose was: (Oral-VRL', 'epirubicin', 'vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI', 'EPI co-administration', 'vinorelbine']","['Similar blood PK profiles, exposures, and VRL clearance', 'quality of life, and cost saving', 'VRL pharmacokinetics (PK', 'Objective response rates']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005768'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",133.0,0.055984,Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL.,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Zhejiang Cancer Hospital, No.1, East Banshan Road, Gongshu District, Hangzhou, 310022, People's Republic of China.""}, {'ForeName': 'Liheng', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Shanghai Jiatong University School of Medicine Renji Hospital, 145 Shandong Middle Rd, Huangpu Qu, Shanghai, 200333, People's Republic of China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Di', 'Affiliation': ""Beijing Cancer Hospital, 52 Fucheng Rd, Wu Ke Song, Beijing, 100091, People's Republic of China.""}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Fujian Provincial Cancer Hospital, 91 Fengban Maluding, Fuma Lu, Jin'an District, Fuzhou, 350014, People's Republic of China.""}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""307 Hospital of PLA, 8 East St, Fengtai Qu, Beijing, 100160, People's Republic of China.""}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shangdong Cancer Hospital, Jinan, 250117, People's Republic of China.""}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Guangxi Medical University Affiliated Cancer Hospital, Fukang Rd, Qingxiu Qu, Nanning, 530015, People's Republic of China.""}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Jiangsu Cancer Hospital, Nanjing, 210009, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Tongji Hospital, No.1095 Jie Fang Avenue, Hankou, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""The First Hospital of China Medical University, Taiyuan Street Business Area, Heping, Shenyang, 110003, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""West China Hospital of Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': ""Ruijin Hospital Shanghai Jiao Tong University School of Medicine, No. 197, Rui Jin Er Road, Shanghai, 200025, People's Republic of China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Binshui Rd, Hexi Qu, Tianjin, 300011, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China. zhimingshao@outlook.com.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-04000-3'] 3321,31364474,Feasibility and efficacy of a web-based family telehealth nutrition intervention to improve child weight status and dietary intake: A pilot randomised controlled trial.,"INTRODUCTION Innovative eHealth solutions that improve access to child weight management interventions are crucial to address the rising prevalence of childhood obesity globally. The study aimed to evaluate the feasibility and preliminary efficacy of a 12-week online telehealth nutrition intervention to improve child weight and dietary outcomes, and the impact of additional text messages (SMS) targeted to mothers and fathers. METHODS Families with children aged 4 to 11 were randomised across three groups: Telehealth, Telehealth+SMS, or Waitlist control. Telehealth and Telehealth+SMS groups received two telehealth consultations delivered by a dietitian, 12 weeks access to a nutrition website and a private Facebook group. The Telehealth+SMS group received additional SMS. Feasibility was assessed through recruitment, retention, and intervention utilisation. Efficacy was assessed through changes in measured child body mass index (BMI), waist circumference and diet. RESULTS Forty-four (96%) and 36 (78%) families attended initial and second telehealth consultations, respectively. Thirty-six families (78%) completed week 12 assessments. Child BMI and waist circumference changes from baseline to week 12 were not statistically different within or between groups. Children in Telehealth+SMS had significantly reduced percentage energy from energy-dense nutrient-poor food (95% CI -21.99 to -0.03%E; p  = .038) and increased percentage energy from healthy core food (95% CI -0.21 to 21.89%E; p  = .045) compared to Waitlist control. DISCUSSION A family-focused online telehealth nutrition intervention is feasible. While the modest sample size reduced power to detect between-group changes in weight status, some improvements in child dietary intakes were identified in those receiving telehealth and SMS.",2019,,[],['web-based family telehealth nutrition intervention'],"['Feasibility and efficacy', 'child weight status and dietary intake']",[],"[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0748469,,"[{'ForeName': 'Li Kheng', 'Initials': 'LK', 'LastName': 'Chai', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'May', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ashman', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Holder', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, Australia.'}, {'ForeName': 'Leanne J', 'Initials': 'LJ', 'LastName': 'Brown', 'Affiliation': 'University of Newcastle Department of Rural Health, The University of Newcastle, North Tamworth Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Callaghan, Australia.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19865855'] 3322,31358336,The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial.,"OBJECTIVES To compare the cardioprotective efficacy of a solution that requires only a single infusion at the start of the ischemic duration versus a solution that requires multiple infusions. METHODS Aortic valve replacement was performed for 150 patients, who were randomized into the del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group. The DN cardioplegia was delivered every 90 minutes and the CB cardioplegia was delivered every 20 to 30 minutes, or whenever cardiac activity was observed. The primary endpoints were electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme) at 24 and 48 hours. RESULTS Electrical activity during crossclamp occurred in 29 (39.7%) patients in the DN group versus 34 (45.3%) patients in the CB group (adjusted P = 1.0). The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41). Troponin values appeared to be lower in the DN group (median, 223.10; interquartile range, 168.35-364.77 pg/mL vs 285.5; 196.20-419.45 pg/mL at 24 hours and 159.60; 125.42-217.20 pg/mL vs 201.60; 160.62-268.45 pg/mL at 48 hours) and CK-MB (median, 14.94; interquartile range, 12.16-20.39 ng/mL vs 17.43; 13.66-22.43 ng/mL at 24 hours and 6.19; 4.41-7.63 ng/mL vs 7.38; 4.74-10.20 ng/mL at 48 hours), but no significance was found. CONCLUSIONS The del Nido cardioplegia protocol is an acceptable alternative for cold blood cardioplegia in patients undergoing aortic valve replacement.",2020,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","['patients undergoing aortic valve replacement', 'aortic valve replacement', 'Aortic valve replacement was performed for 150 patients']","['cold blood cardioplegia', 'CB cardioplegia', 'del Nido (DN) cardioplegia group or the cold blood (CB) cardioplegia group']","['number of procedures with ventricular fibrillation', 'Troponin values', 'electrical cardiac activity during crossclamp, ventricular fibrillation during reperfusion, and postoperative troponin and creatine kinase (CK-MB isoenzyme', 'cardioprotective efficacy', 'Electrical activity during crossclamp']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0005768'}, {'cui': 'C0018791', 'cui_str': 'Cardioplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity (observable entity)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C0022173', 'cui_str': 'Isozymes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",150.0,0.149311,"The number of procedures with ventricular fibrillation after removing the crossclamp was 41 (54.7%) in the CB group versus 17 (22.7%) in the DN group (adjusted P = .001; relative risk, 2.41).","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Sanetra', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland. Electronic address: krzyssan@poczta.onet.pl.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Gerber', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Domaradzki', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Krzych', 'Affiliation': 'Department of Anesthesiology and Intensive Therapy, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Zembala', 'Affiliation': 'Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Cisowski', 'Affiliation': '1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biała, Poland; Center for Cardiovascular Research and Development, American Heart of Poland, Bielsko-Biała, Poland; Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Zabrze, Poland; Medical University of Silesia, Katowice, Poland.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.05.083'] 3323,31830753,Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial.,"BACKGROUND Recently, the role of neural modulation in nonauditory cortices via repetitive transcranial magnetic stimulation (rTMS) for tinnitus control has been emphasized. It is now more compelling to consider these nonauditory cortices and the whole ""tinnitus network"" as targets for tinnitus treatment to achieve a better outcome. OBJECTIVE We aimed to investigate the effects of active dual-site rTMS treatment in tinnitus reduction using a double-blind randomized controlled trial. METHOD In study 1, the dual-site rTMS treatment group (n = 17) was treated daily for 4 consecutive days. The sham group (n = 13) also visited the clinic for 4 days; they received sham treatment for the same duration as the dual-site rTMS treatment group. In study 2, the rTMS treatment protocol was exactly the same as in study 1. Magnetoencephalography recordings were performed before and 1 week after the last rTMS treatment. The outcome measure was the Tinnitus Handicap Inventory (THI) score and the visual analog scale score. The effects of treatment were assessed 1, 2, 4, and 8 weeks after rTMS treatment in study 1. Then the mean band power and network changes were compared between pre- and post-treatment values after rTMS in study 2. RESULT Patients in the dual-site rTMS treatment group exhibited significantly improved THI scores at 2, 4, and 8 weeks after rTMS treatment compared with the pretreatment scores. However, the sham group did not show any significant reduction in THI scores. When the mean band power changes were compared between pre- and post-treatment assessments, an increased oscillation power was observed in the alpha band after rTMS. CONCLUSION A beneficial effect of rTMS on tinnitus suppression was found in the dual-site active rTMS group, but not in the sham rTMS group.",2019,"A beneficial effect of rTMS on tinnitus suppression was found in the dual-site active rTMS group, but not in the sham rTMS group.",['Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS'],"['rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'active dual-site rTMS', 'Auditory and Frontal Dual-Site rTMS']","['oscillation power', 'mean band power and network changes', 'tinnitus suppression', 'Tinnitus Handicap Inventory (THI) score and the visual analog scale score', 'THI scores']","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",17.0,0.0938687,"A beneficial effect of rTMS on tinnitus suppression was found in the dual-site active rTMS group, but not in the sham rTMS group.","[{'ForeName': 'Tae-Soo', 'Initials': 'TS', 'LastName': 'Noh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Sug', 'Initials': 'JS', 'LastName': 'Kyong', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, Audiology Institute, Hallym University of Graduate Studies, Seoul, Republic of Korea.'}, {'ForeName': 'Moo Kyun', 'Initials': 'MK', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ha', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Brain and Cognitive Science, Seoul National University College of Natural Science, Seoul, Republic of Korea.'}, {'ForeName': 'June Sic', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Brain and Cognitive Science, Seoul National University College of Natural Science, Seoul, Republic of Korea.'}, {'ForeName': 'Myung-Whan', 'Initials': 'MW', 'LastName': 'Suh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea, drmung@naver.com.'}]",Audiology & neuro-otology,['10.1159/000503134'] 3324,31961463,Metformin plus megestrol acetate compared with megestrol acetate alone as fertility-sparing treatment in patients with atypical endometrial hyperplasia and well-differentiated endometrial cancer: a randomised controlled trial.,"OBJECTIVE To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC). DESIGN A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017. SETTING Shanghai OBGYN Hospital of Fudan University, China. POPULATION A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76). METHODS Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day). MAIN OUTCOMES AND MEASURES The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events. RESULTS The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints. CONCLUSION As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients. TWEETABLE ABSTRACT For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.",2020,"No significant result was found in secondary endpoints. ","['group (n=76', 'Totally 150 patients (18-45 years old) with primary AEH or well-differentiated EEC', 'patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC', 'Patients with AEH or EEC', 'patients with atypical endometrial hyperplasia and well differentiated endometrial cancer', 'Shanghai OBGYN hospital of Fudan university, China', 'October 2013 and December 2017']","['Metformin plus Megestrol Acetate (MA', 'metformin', 'MA plus metformin', 'metformin plus MA', 'MA alone', 'megestrol acetate (MA)-based fertility-sparing treatment', 'MA']","['CR rate and adverse events', 'cumulate complete response (CR) rates', 'early CR rate', 'CR rate', 'insulin-sensitive']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065879', 'cui_str': 'Megestrol Acetate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]",150.0,0.149445,"No significant result was found in secondary endpoints. ","[{'ForeName': 'B-Y', 'Initials': 'BY', 'LastName': 'Yang', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gulinazi', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Epidemiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Ning', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'W-W', 'Initials': 'WW', 'LastName': 'Shan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-Z', 'Initials': 'XZ', 'LastName': 'Luo', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'H-W', 'Initials': 'HW', 'LastName': 'Zhang', 'Affiliation': 'Department of Cervical Diseases, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'F-H', 'Initials': 'FH', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Sonography, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Shanghai JiAi Genetics and IVF Institute, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'X-J', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': 'Department of Gynaecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16108'] 3325,31359053,Cost-effectiveness of an Environmental Cleaning Bundle for Reducing Healthcare-associated Infections.,"BACKGROUND Healthcare-associated infections (HAIs) remain a significant patient safety issue, with point prevalence estimates being ~5% in high-income countries. In 2016-2017, the Researching Effective Approaches to Cleaning in Hospitals (REACH) study implemented an environmental cleaning bundle targeting communication, staff training, improved cleaning technique, product use, and audit of frequent touch-point cleaning. This study evaluates the cost-effectiveness of the environmental cleaning bundle for reducing the incidence of HAIs. METHODS A stepped-wedge, cluster-randomized trial was conducted in 11 hospitals recruited from 6 Australian states and territories. Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia, Clostridium difficile infection, and vancomycin-resistant enterococci infections prevented in the intervention phase based on estimated reductions in the relative risk of infection. Changes to costs were defined as the cost of implementing the bundle minus cost savings from fewer infections. Health benefits gained from fewer infections were measured in quality-adjusted life-years (QALYs). Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefit of adopting the cleaning bundle over existing hospital cleaning practices. RESULTS Implementing the cleaning bundle cost $349 000 Australian dollars (AUD) and generated AUD$147 500 in cost savings. Infections prevented under the cleaning bundle returned a net monetary benefit of AUD$1.02 million and an incremental cost-effectiveness ratio of $4684 per QALY gained. There was an 86% chance that the bundle was cost-effective compared with existing hospital cleaning practices. CONCLUSIONS A bundled, evidence-based approach to improving hospital cleaning is a cost-effective intervention for reducing the incidence of HAIs.",2020,"Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections prevented in the intervention phase, based on estimated reductions in the relative risk of infection.",['eleven hospitals recruited from six Australian states and territories'],['environmental cleaning bundle'],"['Cost-effectiveness', 'numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections', 'incremental cost-effectiveness ratio', 'cost-effectiveness', 'Bundle effectiveness']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1142423', 'cui_str': 'Bacteremia caused by Staphylococcus aureus'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0429117,"Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia (SAB), Clostridium difficile infection (CDI) and vancomycin-resistant enterococci (VRE) infections prevented in the intervention phase, based on estimated reductions in the relative risk of infection.","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'White', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Brett G', 'Initials': 'BG', 'LastName': 'Mitchell', 'Affiliation': 'Discipline of Nursing, Avondale College of Higher Education, Wahroonga, New South Wales, Western Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Farrington', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Halton', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Paterson', 'Affiliation': ""University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital, Crawley, Western Australia.""}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Riley', 'Affiliation': 'School of Biomedical Sciences, The University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardner', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'School of Public Healt, New South Wales,h and Social Work, Queensland University of Technology, Brisbane, Western Australia.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Gericke', 'Affiliation': 'School of Clinical Medicine, University of Queensland, Cairns, Queensland, Brisbane, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Graves', 'Affiliation': 'Australian Centre for Health Services Innovation, Institute of Health and Biomedical Innovation, Brisbane, Queensland, Western Australia.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz717'] 3326,3065499,The middle ear in cleft palate children pre and post palatal closure.,"A multicentre prospective trial was commenced in July 1984 to establish the incidence of otitis media with effusion (OME) in children born with a cleft of the palate. Additionally, the data recorded would allow an assessment of the effect of palatal closure on middle ear function. Prior to palatal closure, 97% of ears in a group of 50 patients had otitis media with effusion (OME). The insertion of a long-term ventilation tube provided a means of aeration of one ear with the non-ventilated ear acting as a control. Eighty percent of control ears had persistent OME during a 24-month follow-up period post palatal repair. It would seem that OME is universally present in children with a cleft palate prior to 4 months of age and this incidence is only marginally diminished by palatal surgery. The liaison between plastic surgical and ENT units should be even closer than before in order to manage these patients satisfactorily.",1988,Eighty percent of control ears had persistent OME during a 24-month follow-up period post palatal repair.,"['children born with a cleft of the palate', '50 patients had otitis media with effusion (OME']",['OME'],"['persistent OME', 'otitis media with effusion (OME']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}]",[],"[{'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}]",,0.0280051,Eighty percent of control ears had persistent OME during a 24-month follow-up period post palatal repair.,"[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Dhillon', 'Affiliation': 'Department of Otolarngology, University College Hospital, London.'}]",Journal of the Royal Society of Medicine,[] 3327,2939239,Single-dose antibiotic prophylaxis of abdominal surgical wound infection: a trial of preoperative latamoxef against peroperative tetracycline lavage.,"A randomized controlled clinical trial was undertaken in 542 consecutive emergency and elective abdominal operations, with one group of patients receiving tetracycline peritoneal and wound lavage and the other a single intravenous injection of 1 g latamoxef at induction of anaesthesia. Seventy-five patients were withdrawn because no potentially contaminated hollow viscus was opened, and a further 36 because they could not be assessed for wound infection. Of the remaining 431 patients, 212 received latamoxef resulting in 5 major and 8 minor wound infections in hospital; another 4 minor infections occurred at home (total incidence 8.0%). In the tetracycline group (n = 219) there were 7 major and 19 minor wound infections in hospital and 10 minor infections later (total incidence 16.4%). This is significantly higher than the rate with latamoxef (P = 0.012). Monitoring of operative and postoperative bleeding revealed no evidence (except in one doubtful case) of excessive bleeding associated with the use of a single dose of latamoxef. It is concluded that single-dose preoperative latamoxef is more effective than peroperative tetracycline lavage for the prevention of wound infections after potentially contaminated abdominal operations.",1986,Monitoring of operative and postoperative bleeding revealed no evidence (except in one doubtful case) of excessive bleeding associated with the use of a single dose of latamoxef.,"['abdominal surgical wound infection', '542 consecutive emergency and elective abdominal operations, with one group of patients receiving tetracycline peritoneal and wound lavage and the other a single intravenous injection of 1 g latamoxef at induction of anaesthesia']","['peroperative tetracycline lavage', 'latamoxef', 'latamoxef against peroperative tetracycline lavage', 'tetracycline']",[],"[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0026651', 'cui_str': 'latamoxef'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}]","[{'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0026651', 'cui_str': 'latamoxef'}]",[],542.0,0.0368441,Monitoring of operative and postoperative bleeding revealed no evidence (except in one doubtful case) of excessive bleeding associated with the use of a single dose of latamoxef.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sauven', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Playforth', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Pollock', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3328,3323512,What time of day should a urethral catheter be removed?,"Patients who had undergone bladder neck surgery were randomized to having their urethral catheters removed either early in the morning or late at night. There was no difference in the incidence of urinary retention between these two groups of patients. However, patients who presented with acute urinary retention had a higher incidence of postoperative urinary retention. This study suggests that a urethral catheter may be safely removed in the evening without increasing the risk of urinary retention. There also seems to be no greater chance of the patient having to be recatheterized at an unsocial hour.",1987,There was no difference in the incidence of urinary retention between these two groups of patients.,['Patients who had undergone bladder neck surgery'],[],"['postoperative urinary retention', 'incidence of urinary retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.024356,There was no difference in the incidence of urinary retention between these two groups of patients.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wyman', 'Affiliation': 'Department of Surgery, Derbyshire Royal Infirmary.'}]",Journal of the Royal Society of Medicine,[] 3329,3278115,Use of ultrasound localization to improve results of fine needle aspiration cytology of breast masses.,"A prospective randomized controlled trial of 116 patients with breast masses was conducted to compare the accuracy of 'blind' aspiration cytology performed in the clinic with aspiration cytology using ultrasound localization. The unsatisfactory aspiration cytology rate was significantly reduced by ultrasound localization (P = 0.028). This was mainly due to an improvement in the unsatisfactory rate for tumours less than 3 cm in diameter (P = 0.036). The results were influenced by the number of needle manoeuvres performed, less than 10 needle manoeuvres being associated with a 54% unsatisfactory aspiration rate compared with 25% when greater than 10 manoeuvres were performed (P = less than 0.02). One experienced aspirator in the clinic had results comparable to those achieved with ultrasound localization. It is concluded that experience and technique are the most important factors in obtaining a satisfactory aspirate from breast masses. Routine ultrasound localization prior to aspiration confers some benefit. Consideration should be given to the use of the ultrasound-assisted technique following a previous unsatisfactory aspiration, particularly if the tumour is less than 3 cm in diameter.",1988,The unsatisfactory aspiration cytology rate was significantly reduced by ultrasound localization (P = 0.028).,['116 patients with breast masses'],['ultrasound localization'],"['number of needle manoeuvres', 'unsatisfactory aspiration cytology rate', 'unsatisfactory aspiration rate']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}]",116.0,0.0192444,The unsatisfactory aspiration cytology rate was significantly reduced by ultrasound localization (P = 0.028).,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Patel', 'Affiliation': 'University Surgical Unit, University of Southampton.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Gartell', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Guyer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Herbert', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Taylor', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3330,31443732,Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial.,"BACKGROUND Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women. There is strong evidence that patient-level factors are associated with outcomes, which justifies targeting them with intervention. While evidence-based self-management interventions that incorporate both social support and health education have reduced pain, improved function, and delayed disability among patients with SLE, African Americans and women are still disproportionately impacted by SLE. Peer mentoring interventions are effective in other chronic conditions that disproportionately affect minorities, such as diabetes mellitus, HIV, and kidney disease, but there is currently no empirically tested peer mentoring intervention developed for patients with SLE. Preliminary data from our group suggest that peer mentoring improves self-management, reduces disease activity, and improves health-related quality of life (HRQOL) in African American women with SLE. METHODS This study will test an innovative, manualized peer mentorship program designed to provide modeling and reinforcement by peers (mentors) to other African American women with SLE (mentees) to encourage them to engage in activities that promote disease self-management. Through a randomized, ""mentored"" or ""support group"" controlled design, we will assess the efficacy and mechanism(s) of this intervention in self-management, disease activity, and HRQOL. DISCUSSION This is the first study to test peer mentorship as an alternative strategy to improve outcomes in African American women with SLE. This could result in a model for other programs that aim to improve disease self-management, disease activity, and HRQOL in African American women suffering from chronic illness. The peer mentoring approach is uniquely fitted to African Americans, and this intervention has the potential to lead to health improvements for African American women with SLE that have not been attainable with other interventions. This would significantly reduce disparities and have considerable public health impact. TRIAL REGISTRATION ClinicalTrials.gov, NCT03734055 . Registered on 27 November 2018.",2019,"African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women.","['patients with SLE', 'African American women with SLE', 'African American women with lupus with a social support control', 'peers (mentors) to other African American women with SLE (mentees', 'African Americans', 'patients with SLE, African Americans and women', 'African American women suffering from chronic illness']","['Peer approaches to self-management (PALS', 'peer mentoring approach', 'Peer mentoring interventions']","['morbidity, mortality, healthcare costs and decreased quality of life', 'self-management, reduces disease activity, and improves health-related quality of life (HRQOL', 'pain, improved function, and delayed disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0037438'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.0940384,"African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women.","[{'ForeName': 'Edith M', 'Initials': 'EM', 'LastName': 'Williams', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite CS303D, Charleston, SC, 29425, USA. wiled@musc.edu.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Egede', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jim C', 'Initials': 'JC', 'LastName': 'Oates', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, 96 Jonathan Lucas St, Charleston, SC, 29425, USA.'}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Dismuke', 'Affiliation': 'Heath Economics Resource Center (HERC), VA Palo Alto Medical Care System, 795 Willow Road (152 MPD), Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite CS303D, Charleston, SC, 29425, USA.'}, {'ForeName': 'Trevor D', 'Initials': 'TD', 'LastName': 'Faith', 'Affiliation': 'Division of Rheumatology and Immunology, Medical University of South Carolina, 96 Jonathan Lucas St, Charleston, SC, 29425, USA.'}, {'ForeName': 'Hetlena', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Lupus Columbia SC, 1900 Kathleen Drive, Columbia, SC, 29210, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Rose', 'Affiliation': 'Department of Social Work Programs, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA.'}]",Trials,['10.1186/s13063-019-3580-4'] 3331,32075887,Mediterranean diet intervention in overweight and obese subjects lowers plasma cholesterol and causes changes in the gut microbiome and metabolome independently of energy intake.,"OBJECTIVES This study aimed to explore the effects of an isocaloric Mediterranean diet (MD) intervention on metabolic health, gut microbiome and systemic metabolome in subjects with lifestyle risk factors for metabolic disease. DESIGN Eighty-two healthy overweight and obese subjects with a habitually low intake of fruit and vegetables and a sedentary lifestyle participated in a parallel 8-week randomised controlled trial. Forty-three participants consumed an MD tailored to their habitual energy intakes (MedD), and 39 maintained their regular diets (ConD). Dietary adherence, metabolic parameters, gut microbiome and systemic metabolome were monitored over the study period. RESULTS Increased MD adherence in the MedD group successfully reprogrammed subjects' intake of fibre and animal proteins. Compliance was confirmed by lowered levels of carnitine in plasma and urine. Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group. Shotgun metagenomics showed gut microbiome changes that reflected individual MD adherence and increase in gene richness in participants who reduced systemic inflammation over the intervention. The MD intervention led to increased levels of the fibre-degrading Faecalibacterium prausnitzii and of genes for microbial carbohydrate degradation linked to butyrate metabolism. The dietary changes in the MedD group led to increased urinary urolithins, faecal bile acid degradation and insulin sensitivity that co-varied with specific microbial taxa. CONCLUSION Switching subjects to an MD while maintaining their energy intake reduced their blood cholesterol and caused multiple changes in their microbiome and metabolome that are relevant in future strategies for the improvement of metabolic health.",2020,Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group.,"['overweight and obese subjects', 'Forty-three participants consumed an MD tailored to their habitual energy intakes (MedD), and 39 maintained their regular diets (ConD', 'Eighty-two healthy overweight and obese subjects with a habitually low intake of fruit and vegetables and a sedentary lifestyle participated', 'subjects with lifestyle risk factors for metabolic disease']","['Mediterranean diet intervention', 'isocaloric Mediterranean diet (MD) intervention']","['urinary urolithins, faecal bile acid degradation and insulin sensitivity', 'faecal bile acids', 'blood cholesterol', 'MD adherence', 'Dietary adherence, metabolic parameters, gut microbiome and systemic metabolome', 'metabolic health, gut microbiome and systemic metabolome', 'plasma cholesterol', 'individual MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",43.0,0.0294261,Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Meslier', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Henrik Munch', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Roume', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Quinquis', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Institute of Food Science of CNR, Avellino, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Mennella', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Ferracane', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pons', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Pasolli', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Rivellese', 'Affiliation': 'Task Force on Microbiome Studies, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}, {'ForeName': 'Stanislav Dusko', 'Initials': 'SD', 'LastName': 'Ehrlich', 'Affiliation': 'Université Paris-Saclay, INRAE, MGP, Jouy-en-Josas, France ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it stanislav.ehrlich@inra.fr paola.vitaglione@unina.it.'}]",Gut,['10.1136/gutjnl-2019-320438'] 3332,32063220,Retraining for prevention of peritonitis in peritoneal dialysis patients: A randomized controlled trial.,"BACKGROUND Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients. METHODS This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015. New peritonitis-free PD patients were randomized using computer-generated numbers 1 month after the start of PD either to a control group ( n = 331) treated according to center routines or to a retraining group ( n = 340), which underwent testing of PD knowledge and skills at 1, 3, 6, 12, 18, 24, 30, and 36 months after PD start, followed by retraining if the goals were not achieved. RESULTS In all, 74% of the controls and 80% of the retraining patients discontinued the study. The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16). CONCLUSIONS In this randomized controlled trial, we were unable to demonstrate that regular, targeted testing and retraining of new PD patients increased the time to first peritonitis or reduced the rate of peritonitis, as the study comprised patients with a low risk of peritonitis, was underpowered, open to type 1 statistical error, and contamination between groups.",2020,"The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16). ","['New peritonitis-free PD patients', '57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015', 'new PD patients', 'peritoneal dialysis patients']",[],"['cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death', 'rate of peritonitis', 'peritonitis rate']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0014908', 'cui_str': 'Estonia'}, {'cui': 'C0023128', 'cui_str': 'Republic of Latvia'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.105394,"The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65-1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75-1.16). ","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ljungman', 'Affiliation': 'Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Jørgen E', 'Initials': 'JE', 'LastName': 'Jensen', 'Affiliation': 'Department of Nephrology, Odense University Hospital, Denmark.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Paulsen', 'Affiliation': 'Department of Medicine, Innlandet Hospital HF, Lillehammer, Norway.'}, {'ForeName': 'Aivars', 'Initials': 'A', 'LastName': 'Petersons', 'Affiliation': 'Nephrology Center, Department of Medicine, P. Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Ots-Rosenberg', 'Affiliation': 'Department of Internal Medicine, University Hospital of Tartu, Estonia.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Saha', 'Affiliation': 'Department of Internal Medicine, Tampere University Hospital, Finland.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Struijk', 'Affiliation': 'Medisch Centrum, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilkie', 'Affiliation': 'Renal Unit, Department of Nephrology, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, UK.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Heimbürger', 'Affiliation': 'Patient Area Endocrinology and Nephrology, Karolinska University Hospital and Department of Clinical Science, Intervention, and Technology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Stegmayr', 'Affiliation': 'Department of Nephrology, Public Health, and Clinical Medicine, Umeå University, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elung-Jensen', 'Affiliation': 'Department of Nephrology, Rigshospitalet University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ann-Cathrine', 'Initials': 'AC', 'LastName': 'Johansson', 'Affiliation': 'Department of Nephrology, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Rydström', 'Affiliation': 'Department of Nephrology, Skaraborg Hospital, Skövde, Sweden.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Gudmundsdottir', 'Affiliation': 'Department of Nephrology, Oslo University Hospital Ullevål, Norway.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Petzold', 'Affiliation': 'Health Metrics Unit, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis,['10.1177/0896860819887626'] 3333,32011032,A randomized controlled study comparing guided bone regeneration with connective tissue graft to re-establish buccal convexity: One-year aesthetic and patient-reported outcomes.,"OBJECTIVES To compare guided bone regeneration (GBR) with connective tissue graft (CTG) in terms of aesthetic and patient-reported outcomes (PROMs). MATERIALS AND METHODS Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect were enrolled in a single-blind RCT. All sites had a buccopalatal bone dimension of at least 6 mm, received a single implant and were randomly allocated to the control (GBR) or test group (CTG) to re-establish buccal soft tissue convexity. Primary outcomes were Pink Esthetic Score (PES) and Mucosal Scarring Index (MSI) assessed after 1 year. Secondary outcomes included PROMs registered during the early stages of healing and after 1 year. RESULTS Twenty-one patients were included per group (control: 11 females, mean age 51; test: nine females, mean age 48). Although there was no significant difference in the PES between the groups (control: 10.11; test: 10.48; p = .577), the MSI was significantly lower in the test (1.10) than in the control group (2.53) (p = .017). Based on descriptive statistics, the latter demonstrated wider scars, more colour mismatch and slightly more suture marks. However, these were not considered disturbing by the patients given similar VAS on soft tissue aesthetics (control: 84; test: 87). Oedema and haematoma were rated twice as high in the control group on at least two postoperative time points, and patients took more painkillers (7.10 vs. 4.86). OHIP-14 decreased in both groups between baseline and 1-year follow-up, indicative of less discomfort in daily life. Differences in MSI and PROMs between the groups may be explained by the need of a vertical releasing incision in order to achieve sufficient access for GBR, periosteal incisions and the use of biomaterials that may induce inflammation. CONCLUSION GBR and CTG resulted in favourable aesthetic outcomes as assessed by professionals and patients. However, given additional vertical and periosteal incisions, GBR resulted in more scarring, postoperative discomfort and a higher need for painkillers.",2020,Oedema and hematoma were rated twice as high in the control group on at least two postoperative time points and patients took more painkillers (7.10 versus 4.86).,"['Twenty-one patients were included per group (control: 11 females', 'mean age 51; test: 9 females, mean age 48', 'Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect were enrolled in a single-blind RCT']","['GBR and CTG', 'control (GBR) or test group (CTG) to re-establish buccal soft tissue convexity', 'guided bone regeneration with connective tissue graft to re-establish buccal convexity', 'guided bone regeneration (GBR) with connective tissue graft (CTG', 'VAS']","['PROMs registered during the early stages of healing and after 1 year', 'favorable aesthetic outcomes', 'PES', 'MSI', 'soft tissue aesthetics', 'Oedema and hematoma', 'OHIP-14', 'scarring, postoperative discomfort', 'Pink Esthetic Score (PES) and Mucosal Scarring Index (MSI']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0332585', 'cui_str': 'Pink color (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",21.0,0.0967303,Oedema and hematoma were rated twice as high in the control group on at least two postoperative time points and patients took more painkillers (7.10 versus 4.86).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'De Bruyckere', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Cosyn', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Younes', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Hellyn', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bekx', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cleymaet', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Vrije Universiteit Brussel (VUB), Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Brussels, Belgium.'}]",Clinical oral implants research,['10.1111/clr.13587'] 3334,32049937,"Weekly Teriparatide Versus Bisphosphonate for Bone Union During 6 Months After Multi-Level Lumbar Interbody Fusion for Osteoporotic Patients: A Multicenter, Prospective, Randomized Study.","STUDY DESIGN Multicenter, prospective randomized study. OBJECTIVE Evaluate the impact of weekly teriparatide (WT) and bone contact (BC) status of grafted bone in patients recovering from multilevel lumbar interbody fusion (M-LIF). SUMMARY OF BACKGROUND DATA WT has been reported to significantly improve bone fusion following posterior or transforaminal interbody fusion in osteoporosis patients. METHODS Patients older than 50 years and osteoporotic were recruited. We defined the fusion of two or more consecutive intervertebral levels as M-LIF. All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies. After surgical indication for M-LIF, the subjects were randomly allocated to receive either subcutaneous WT from 1 week to 6 months postoperatively (WT arm, N = 50) or a bisphosphonate (BP; BP arm, N = 54). Blinded radiological evaluations were performed using computed tomography (CT). Evaluation of bone fusion was performed at the intervertebral disc located at the bottom of the fixed range. The degree of bone fusion was calculated as a score from 2 to 6 points, with 2 defined as complete fusion. Bone fusion rate was also compared at 6 months postoperatively based on BC status of the grafted bone on CT immediately after surgery. RESULTS Mean bone fusion score at 6 months postoperatively was 3.9 points in the WT group and 4.2 points in the BP group. The bone fusion rate at 6 months postoperatively tended to be higher in the WT group (46.8% vs. 32.7% in the BP group). The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%). CONCLUSION In M-LIF, there were no significant differences in bone fusion score between WT- and BP-treated patients. In contrast, BC status immediately postoperatively had a major impact on 6-month bone fusion. LEVEL OF EVIDENCE 1.",2020,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%). ","['Osteoporotic Patients', 'patients recovering from multi-level lumbar interbody fusion (M-LIF', 'All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies', 'Patients older than 50 years and osteoporotic were recruited']","['teriparatide (WT) and bone contact (BC) status of grafted bone', 'Teriparatide versus Bisphosphonate', 'bisphosphonate', 'subcutaneous WT', 'BC']","['bone fusion rate', '6-month postoperative fusion rate of immediately postoperative of BC+ patients', 'Mean bone fusion score', 'degree of bone fusion', 'bone fusion score', 'Bone fusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C2722359', 'cui_str': 'S-2'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",,0.037528,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%). ","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yokomichi', 'Affiliation': 'Department of Health Sciences, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Ebata', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopaedic Surgery, North Alps Medical Center Azumi Hospital, Nagano, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shugo', 'Initials': 'S', 'LastName': 'Kuraishi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Ikegami', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Uehara', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takizawa', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Munakata', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Terue', 'Initials': 'T', 'LastName': 'Hatakenaka', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}]",Spine,['10.1097/BRS.0000000000003426'] 3335,3320366,Chronic muscle contraction headache: the importance of depression and anxiety.,"Seventy consecutive patients presenting with a clinical diagnosis of chronic muscle contraction headache over a two-year period were evaluated for depression and anxiety scores, along with other possible aetiological factors in this form of headache. Fifty-five of these patients (33 from a hospital neurology clinic and 22 from a local general practice) completed a double-blind study to evaluate flupenthixol 0.5 mg twice daily, diazepam 5 mg twice daily and placebo as prophylactic agents. Patients evaluated in the hospital neurology clinic had more frequent headaches of longer duration, higher analgesic consumption and higher depression, but no higher anxiety scores than those in general practice. Flupenthixol and diazepam were both significantly superior to placebo in reducing headaches and analgesic consumption. The trend was for flupenthixol to be superior to diazepam without reaching statistical significance. Flupenthixol was significantly better than diazepam and placebo in the reduction of Hamilton depression scores. This effect was independent of the effect on headache and analgesic reduction.",1987,"Patients evaluated in the hospital neurology clinic had more frequent headaches of longer duration, higher analgesic consumption and higher depression, but no higher anxiety scores than those in general practice.","['Fifty-five of these patients (33 from a hospital neurology clinic and 22 from a local general practice', 'Chronic muscle contraction headache', 'Seventy consecutive patients presenting with a clinical diagnosis of chronic muscle contraction headache over a two-year period']","['placebo', 'Flupenthixol', 'flupenthixol 0.5 mg twice daily, diazepam 5 mg twice daily and placebo', 'Flupenthixol and diazepam', 'diazepam']","['headache and analgesic reduction', 'anxiety scores', 'depression and anxiety scores', 'headaches and analgesic consumption', 'frequent headaches of longer duration, higher analgesic consumption and higher depression', 'Hamilton depression scores']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic (environment)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0393736', 'cui_str': 'Muscular headache (disorder)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016367', 'cui_str': 'flupentixol'}, {'cui': 'C1131638', 'cui_str': 'Flupenthixol 0.5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1595472', 'cui_str': 'Diazepam 5 MG [Valium]'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0948396', 'cui_str': 'Frequent headache (finding)'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",70.0,0.0807452,"Patients evaluated in the hospital neurology clinic had more frequent headaches of longer duration, higher analgesic consumption and higher depression, but no higher anxiety scores than those in general practice.","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Hackett', 'Affiliation': 'University of Keele, Department of Postgraduate Medicine, North Staffordshire Medical Institute, Stoke-on-Trent.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Boddie', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3336,30968542,Role of the extent of prophylactic regional lymph node radiotherapy on survival in high-risk neuroblastoma: A report from the COG A3973 study.,"PURPOSE Neuroblastoma is the most common extracranial solid pediatric malignancy, with poor outcomes in high-risk disease. Standard treatment approaches employ an increasing array of aggressive multimodal therapies, of which local control with surgery and radiotherapy remains a backbone; however, the benefit of broad regional nodal irradiation remains controversial. We analyzed centrally reviewed radiation therapy data from patients enrolled on COG A3973 to evaluate the impact of primary site irradiation and the extent of regional nodal coverage stratified by extent of surgical resection. METHODS Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed. Outcome was evaluated by the extent of nodal irradiation. For the 171 patients who also underwent surgery (centrally reviewed), outcome was likewise analyzed according to the extent of resection. Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP) were examined by Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP). RESULTS The five-year CILP, EFS, and OS for all 330 patients receiving radiotherapy on A3973 were 8.5% ± 1.5%, 47.2% ± 3.0%, and 59.7% ± 3.0%, respectively. There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). CONCLUSION Although local control remains a significant component of treatment of high-risk neuroblastoma, our results suggest there is no benefit of extensive lymph node irradiation, irrespective of the extent of surgical resection preceding stem cell transplant.",2019,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). ","['patients enrolled on COG A3973', '171 patients who also underwent surgery (centrally reviewed', '330 patients receiving', 'Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed', 'high-risk neuroblastoma']","['radiotherapy', 'prophylactic regional lymph node radiotherapy']","['degree of surgical resection', 'survival', 'Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP', 'Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",330.0,0.0561755,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). ","[{'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Biostatistics Division, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Villablanca', 'Affiliation': 'Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Davidoff', 'Affiliation': ""Department of Surgery, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'DeSantes', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Castleberry', 'Affiliation': 'Department of Pediatrics, University of Alabama Medical Center, Tuscaloosa, Alabama.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Matthay', 'Affiliation': 'Department of Pediatric Hematology-Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, Section of Hematology/Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Shulkin', 'Affiliation': ""Department of Diagnostic Imaging, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Allmen', 'Affiliation': ""Department of Pediatric Surgery, Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Department of Radiology, University of Washington, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Van Ryn', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'La Quaglia', 'Affiliation': 'Department of Pediatric Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}]",Pediatric blood & cancer,['10.1002/pbc.27736'] 3337,32072216,"A Randomized, Controlled Study Comparing Subbrow Blepharoplasty and Subbrow Blepharoplasty Combined with Periorbital Muscle Manipulation for Periorbital Aging Rejuvenation in Asians.","BACKGROUND Improving periorbital aging is, currently, of great concern. The previous literature has reported some surgical methods for periorbital aging. The purpose of this study was to compare subbrow blepharoplasty (SBB) with subbrow blepharoplasty combined with periorbital muscle manipulation (SBB-pm) with regard to improving periorbital aging. METHODS A prospective, randomized, controlled study was designed to evaluate and compare the effects of two different surgical techniques on upper lid relaxation, brow shape and periorbital wrinkles. Patients were divided into two groups. Group 1 underwent resection of excess skin; group 2 underwent a modified technique that involved resection of an elliptical island of skin, separation of the corrugator supercilii muscle and dissection of the orbicularis oculi muscle, followed by suturing it to the orbital periosteum and cross-fixation with itself. The upper eyelid and eyebrow height, periorbital wrinkle score and patient satisfaction were measured preoperatively and postoperatively. RESULTS This study included 70 patients (140 eyes). At 1 month, 3 months, 6 months and 12 months after surgery, group 2 was superior to group 1 with regard to the improvement in upper eyelid relaxation at the medial limbus, middle pupil and lateral canthus. The eyebrow assumed a low and flat appearance in group 1. The eyebrow showed a low and flat appearance and then returned to the preoperative level in group 2. When comparing the two surgical techniques, the authors found statistically significant differences in regard to changes in crow's feet and glabellar frown lines. Two patients in group 2 experienced forehead numbness after surgery, which resolved by the 6-month follow-up. Patients in group 2 were significantly more satisfied with their surgery than patients in group 1. CONCLUSION SBB-pm is more effective than SBB for improving upper eyelid relaxation and preventing secondary brow ptosis after surgery as well as for alleviating periorbital wrinkles, although it is accompanied by transient forehead numbness. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,"At 1 month, 3 months, 6 months and 12 months after surgery, group 2 was superior to group 1 with regard to the improvement in upper eyelid relaxation at the medial limbus, middle pupil and lateral canthus.","['Periorbital Aging Rejuvenation in Asians', '70 patients (140 eyes']","['Subbrow Blepharoplasty and Subbrow Blepharoplasty Combined with Periorbital Muscle Manipulation', 'subbrow blepharoplasty (SBB) with subbrow blepharoplasty combined with periorbital muscle manipulation (SBB-pm', 'SBB', 'resection of excess skin; group 2 underwent a modified technique that involved resection of an elliptical island of skin, separation of the corrugator supercilii muscle and dissection of the orbicularis oculi muscle, followed by suturing it to the orbital periosteum and cross-fixation with itself']","['forehead numbness', 'upper lid relaxation, brow shape and periorbital wrinkles', 'upper eyelid relaxation', 'upper eyelid and eyebrow height, periorbital wrinkle score and patient satisfaction', 'satisfied with their surgery']","[{'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0022130', 'cui_str': 'Islands'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0459563', 'cui_str': 'Orbital periosteum (body structure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0015420', 'cui_str': 'Eyebrows'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",70.0,0.0269323,"At 1 month, 3 months, 6 months and 12 months after surgery, group 2 was superior to group 1 with regard to the improvement in upper eyelid relaxation at the medial limbus, middle pupil and lateral canthus.","[{'ForeName': 'Jianzhang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China.""}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China.""}, {'ForeName': 'Baoqiang', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': ""Department of Plastic and Reconstructive SurgeryXijing Hospital, Fourth Military Medical University, No. 127 Changle West Road, Xi'an, 710032, Shaanxi Province, China. songbq@fmmu.edu.cn.""}]",Aesthetic plastic surgery,['10.1007/s00266-020-01630-4'] 3338,32061508,Felodipine and renal function in lung transplantation: A randomized placebo-controlled trial.,"BACKGROUND Calcium channel blockers may ameliorate the decline in renal function caused by calcineurin inhibitors in lung transplantation (LTX) recipients. We hypothesized that pre-operative and 12-week post-operative treatment with the calcium channel blocker felodipine would reduce the decline in glomerular filtration rate (GFR). METHODS In this prospective, randomized, double-blind trial, 39 LTX recipients were transplanted and received placebo (n = 19; GFR, 102 ml/min/1.73 m 2 [range, 91-113 ml/min/1.73 m 2 ]) or felodipine (n = 20, GFR, 96 ml/min/1.73 m 2 [range, 88-104 ml/min/1.73 m 2 ]). Pre-operative treatment was titrated post-operatively to 10 mg or the maximum tolerable dose. The primary end-point was the change in GFR using Cr-51-labeled EDTA from LTX to 12 weeks thereafter, and follow-up was 52 weeks. RESULTS The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 (95% CI: -40 to 22 ml/min/1.73 m 2 ), whereas that of the placebo group was 48 ml/min/1.73 m 2 (95% confidence interval [CI]: -56 to 40 ml/min/1.73 m 2 ). Thus, the difference between groups at 12 weeks was 17 ml/min/1.73 m 2 (95% CI: 4-29 ml/min/1.73 m 2 ; p = 0.01). Half of the patients were unable to complete the 3-month primary follow-up, and the analysis includes these patients by intention-to-treat. After 52 weeks (40 weeks after termination of treatment), the treatment effect was maintained at 12 ml/min/1.73 m 2 (95% CI: 0-24 ml/min/1.73 m 2 , p = 0.05). The number of days with registered hypotension was significantly higher in the felodipine group than in the placebo group (39 days vs 13 days, rate ratio: 2.9 [95% CI: 1.5-5.3]). CONCLUSIONS Use of felodipine in select patients was associated with greater preservation in renal function early (90 days) after LTX. The observed benefits were attenuated by 1 year, although trends in better renal function were noted.",2020,The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 ,"['lung transplantation', 'lung transplantation (LTX) recipients', '39 LTX recipients were transplanted and received']","['Felodipine', 'placebo', 'calcium channel blocker felodipine', 'felodipine', 'Calcium channel blockers']","['change in GFR', 'glomerular filtration rate (GFR', 'renal function', 'absolute mean decline in GFR', 'number of days with registered hypotension']","[{'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0015772', 'cui_str': 'Felodipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",39.0,0.589463,The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m 2 ,"[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Hornum', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: mads.hornum@regionh.dk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oturai', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads J', 'Initials': 'MJ', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Zemtsovski', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Bredahl', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nina H', 'Initials': 'NH', 'LastName': 'Bjarnason', 'Affiliation': 'Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Carlsen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Perch', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Section for Lung Transplantation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.01.1342'] 3339,32060547,"When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training.","INTRODUCTION Military personnel are at high risk for tobacco use, particularly during the first year of military service. Technical Training follows an 8½ week tobacco ban during basic military training and is a vulnerable time for personnel to both reinitiate and initiate tobacco use. Thus, this can be a crucial time to promote tobacco policies and interventions. However, there is limited research examining when, how, and where personnel access tobacco during the first year of service, particularly among users of newer products (eg, electronic cigarettes[e-cigarettes]). Thus, the purpose of the current study is to explore the timing, source, and location of tobacco use during Technical Training across all types of products. Furthermore, this study will examine differences in demographic characteristics and prior tobacco history in relationship to these tobacco behaviors. MATERIALS AND METHODS Participants were U.S. Air Force recruits completing Technical Training (2017-2018). Protocol was approved by the Institutional Review Board at the 59th Medical Wing of the U.S. Air Force. During the first week of Technical Training, Airmen were consented to participate in the study and completed a questionnaire about demographics and tobacco use history. Next, Airmen were randomized to receive one of three tobacco prevention interventions as part of military training. At a 3-month follow-up, during the last week of Technical Training, consented participants completed a questionnaire about current tobacco use. Airmen reported when (ie, first month vs. after), how (ie, ""bummed"" from another airman, bought on or off base, received from the internet or event), and where (ie, designated smoking areas on base, off base, bar or club, friend's house, cigar lounge, hookah bar, or vape shop) they used tobacco during Technical Training. Descriptive statistics were used to examine these behaviors across all tobacco products. Additionally, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests compared differences in demographic characteristics and baseline tobacco use in relationship to these tobacco behaviors. RESULTS No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use. Additionally, how and where Airmen first used tobacco during Technical Training differed across products. Cigarettes and smokeless tobacco were equally likely to be bought on or off base and most commonly first used at a designated smoking area on base. However, e-cigarettes, cigarillos/little cigars, and hookah were more likely to be bought off base, and first used at a specialty store (ie, vape shop, hookah bar, or cigar lounge). CONCLUSIONS Tobacco use behaviors during Technical Training differed depending on the type of product. Specifically, new and emerging products were more likely to be bought off base and first used at a specialty store. Thus, military polices regulating on base tobacco pricing might not reduce the growing prevalence of e-cigarettes. Future policies might consider addressing the density of off-base tobacco retailers to reduce the high rates of tobacco use in this population.",2020,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.",['Participants were U.S. Air Force recruits completing Technical Training (2017-2018'],['tobacco prevention interventions as part of military training'],['Tobacco Initiation and Relapse Occur'],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0301639,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.","[{'ForeName': 'Margaret Celice', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology; 400 Innovation Drive, Memphis, TN 38111, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tubman', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'University of Tennessee Health Science Center, Department of Preventive Medicine; 66 N Pauline Street Memphis, TN 38163, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}]",Military medicine,['10.1093/milmed/usaa016'] 3340,31365109,Immediate Antihypertensive Treatment for Patients With Acute Ischemic Stroke With or Without History of Hypertension: A Secondary Analysis of the CATIS Randomized Clinical Trial.,"Importance Clinical trials have generally shown a neutral effect of early blood pressure (BP) decreases on clinical outcomes after acute ischemic stroke. Whether the effect of early antihypertensive therapy differs for patients with ischemic stroke with or without prior hypertension is unclear. Objective To investigate the association between immediate antihypertensive treatment and patient outcomes according to the presence or absence of hypertension before stroke onset. Design, Setting, and Participants This study was a prespecified subgroup analysis of the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS), a multicenter, single-blind, blinded end-points randomized clinical trial of 4071 patients with acute ischemic stroke and elevated systolic BP. Patients were recruited from August 2009 to May 2013, and this statistical analysis was performed using the intention-to-treat population from January to October 2018. Interventions Participants were randomly assigned to receive antihypertensive treatment (aimed at decreasing systolic BP by 10%-25% within the first 24 hours after randomization, achieving systolic BP <140 mm Hg and diastolic BP <90 mm Hg within 7 days, and maintaining this level during hospitalization) or to the control arm (discontinued all antihypertensive medications). Main Outcomes and Measures Primary outcome was a combination of death and major disability (modified Rankin Scale score ≥3; range 0-6, with higher values indicating greater disability) at 14 days or hospital discharge. Results In total, 2038 patients were randomized to receive antihypertensive treatment, and 2033 patients were randomized to the control group. The mean (SD) age was 62.0 (10.9) years, and 2604 participants (64.0%) were men. At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity): odds ratios (ORs) associated with treatment were 1.00 (95% CI, 0.87-1.16) for patients with prior hypertension and 1.00 (95% CI, 0.75-1.32) for patients without. Early antihypertensive treatment was associated with different rates of 3-month recurrent stroke (patients with hypertension: OR, 0.44; 95% CI, 0.25-0.77 vs without hypertension: OR, 3.43; 95% CI, 0.94-12.55; P = .005 for homogeneity) and vascular events (patients with hypertension: OR, 0.66; 95% CI, 0.43-1.02 vs those without hypertension: OR, 1.91; 95% CI, 0.75-4.83; P = .04 for homogeneity) by hypertension history. Conclusions and Relevance Among patients with acute ischemic stroke, early antihypertensive treatment was not associated with different death and major disability outcomes by hypertension history. However, early antihypertension therapy was associated with a decreased rate of recurrent stroke among patients with a history of hypertension and may inform future studies in the optimal approach to hypertension management in the setting of acute ischemic stroke. Trial Registration ClinicalTrials.gov identifier: NCT01840072.",2019,"At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity):","['patients with ischemic stroke with or without prior hypertension is unclear', 'Patients With Acute Ischemic Stroke', '2038 patients were randomized to receive antihypertensive treatment, and 2033 patients', 'Patients were recruited from August 2009 to May 2013, and this statistical analysis was performed using the intention-to-treat population from January to October 2018', 'patients with acute ischemic stroke', 'The mean (SD) age was 62.0 (10.9) years, and 2604 participants (64.0%) were men', '4071 patients with acute ischemic stroke and elevated systolic BP', 'Hypertension']",['antihypertensive treatment'],"['combination of death and major disability (modified Rankin Scale score ≥3; range 0-6, with higher values indicating greater disability) at 14 days or hospital discharge', 'rates of 3-month recurrent stroke', 'systolic BP', 'systolic BP <140 mm Hg and diastolic BP', 'odds ratios (ORs', 'rate of recurrent stroke', 'vascular events', 'blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]","[{'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",2038.0,0.226513,"At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity):","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Chongke', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhengbao', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Hebei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Qunwei', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Taishan Medical College, Shandong, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': ""Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia, China.""}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Xuzhou Medical College, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.8103'] 3341,31358329,Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.,"OBJECTIVE In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.",2020,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","['patients undergoing isolated coronary artery bypass grafting (CABG) surgery', 'patients undergoing cardiac surgery', 'Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial', 'patients with reduced left ventricular function undergoing isolated coronary or valve surgery']","['placebo', 'levosimendan', 'Levosimendan', 'levosimendan and placebo']","['co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs', 'valve', 'LCOS', 'median and mean 30-day costs', '90-day mortality and LCOS', 'Ninety-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]",,0.314909,"The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%).","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Division of Cardiology, Departments of Critical Care and Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada. Electronic address: sv9@ualberta.ca.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Leimberger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada; Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Schulich Heart Center, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Tenax Therapeutics, Morrisville, NC.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jerrold H', 'Initials': 'JH', 'LastName': 'Levy', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Luber', 'Affiliation': 'Franciscan Health System, Tacoma, Wash.'}, {'ForeName': 'A Dave', 'Initials': 'AD', 'LastName': 'Nagpal', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Andra E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Argenziano', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Toller', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Teoh', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Knight', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cowper', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.06.020'] 3342,32050858,From a terror management perspective: The efficacy of self-affirmation on organ donation-related thoughts and intentions in China.,"In 2015, the Chinese government officially abolished the practice of harvesting organs from executed prisoners. However, the voluntary donor registration rate among the Chinese population is approximately 2% as of January 2020. Guided by self-affirmation theory and terror management theory, the present investigation examined a number of variables that may be related to donor registration intentions and a method to mitigate death thoughts and misconceptions. An online experiment was conducted in which 352 Chinese participants were randomly assigned to either a self-affirmation (i.e., affirming values that are important to the participants) or a no-affirmation condition. Results revealed that self-affirmation lowered death thoughts among the participants, which in turn were positively related to organ donation misperceptions. Inconsistent with terror management theory, the level of death thoughts was not directly related to participants' intentions to register as organ donors. Instead, the relationship between the two was mediated by misperceptions toward organ donation.",2020,"Results revealed that self-affirmation lowered death thoughts among the participants, which in turn were positively related to organ donation misperceptions.","['China', '352 Chinese participants']",[],"['self-affirmation lowered death thoughts', 'level of death thoughts']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",352.0,0.0223915,"Results revealed that self-affirmation lowered death thoughts among the participants, which in turn were positively related to organ donation misperceptions.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Rochester Institute of Technology.'}]",The Journal of social psychology,['10.1080/00224545.2020.1726858'] 3343,2687467,Is a drain necessary after colonic anastomosis?,"To date, there have been no clinical investigations of the usefulness of drains following colonic anastomosis in elective operations. We report a prospective study in which 49 patients were randomized to have a corrugated silastic drain (Portex) placed next to the colonic anastomosis. These patients were compared with a control group of 57 patients who had no drain. The two groups were similar in age, sex, diagnosis and site of anastomosis. There was no difference in outcome between the two groups. Anastomotic leakage occurred in six patients in each group. Wound infections were noted in 10 patients in each group. Two patients with a drain and one patient without a drain died from leakage at the anastomosis. This study provides no evidence to support the use of a corrugated drain after anastomosis of the colon.",1989,There was no difference in outcome between the two groups.,"['49 patients', '57 patients who had no drain', '10 patients in each group', 'Two patients with a drain and one patient without a drain died from leakage at the anastomosis']",['corrugated silastic drain (Portex) placed next to the colonic anastomosis'],"['Wound infections', 'Anastomotic leakage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]","[{'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0852681', 'cui_str': 'Large intestine anastomosis'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}]",49.0,0.0192033,There was no difference in outcome between the two groups.,"[{'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Johnson', 'Affiliation': 'Department of Surgery, Westminster Hospital.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Lamont', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Orr', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lennox', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3344,31990424,Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study).,"BACKGROUND Vonoprazan (V), a potassium-competitive acid blocker, has a more durable acid-inhibitory effect as compared with standard-dose proton pump inhibitors (PPIs) but has not been compared with 2-4 times higher daily PPI doses administered in two divided doses. AIMS To evaluate the acid-inhibitory effect of V 10/20 mg once-daily (OD; V10/V20) vs rabeprazole (R) 10/20 mg twice-daily (BID; R20/R40) in healthy Japanese volunteers. METHODS This multicentre, randomised, open-label, two-period, crossover study compared V10 or V20 vs R20, or V20 vs R40 using three cohorts of 10 healthy Japanese adults. Within each cohort, subjects were randomised to receive V or R for 7 days and, following a washout period ≥7 days, the other treatment for 7 days. On day 6 of each period, 24-hours multichannel gastric impedance-pH monitoring was performed. Percent times pH ≥ 3, ≥4 and ≥5 (pH 3, 4 and 5 holding time ratios [HTRs]) in 24 hours were evaluated as primary pharmacodynamic endpoints. RESULTS Acid-inhibitory effect (24-hours pH 3 HTR) of V20 was greater than those of R20 (91.0% vs 65.3%; P = .0049) and R40 (98.5% vs 85.9%; P = .0073). Similar results were obtained for 24-hours pH 4 and 5 HTRs. V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40. One subject (20%) developed diarrhoea while receiving R40 which was considered treatment-related. CONCLUSIONS Compared with 2-4 times the standard daily dose of R, V20 exerts a more potent and durable acid-inhibitory effect. Trial identifier: UMIN000022198 (www.umin.ac.jp/ctr/index.htm).",2020,V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40.,"['healthy Japanese volunteers (SAMURAI pH study', '10 healthy Japanese adults', 'healthy Japanese volunteers']","['rabeprazole', 'V10 or V20 vs R20, or V20 vs R40', 'acid inhibition by vonoprazan']","['diarrhoea', 'nocturnal pH']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]",,0.116304,V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40.,"[{'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Endoscopic Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Furuta', 'Affiliation': 'Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Mitsushige', 'Initials': 'M', 'LastName': 'Sugimoto', 'Affiliation': 'Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu, Japan.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Kasugai', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Motoyasu', 'Initials': 'M', 'LastName': 'Kusano', 'Affiliation': 'Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Meabashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Kagami', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uotani', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Yamade', 'Affiliation': 'First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Akinari', 'Initials': 'A', 'LastName': 'Sawada', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Endoscopic Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Funaki', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kawamura', 'Affiliation': 'Department of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Meabashi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Internal Medicine, Saga Medical School, Saga, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15641'] 3345,32057088,Titration of sevoflurane anesthesia to optimize the time to regain airway reflexes in patients undergoing elective surgery: A randomized clinical trial comparing desflurane and sevoflurane anesthesia.,"BACKGROUND Desflurane has adverse environmental effects, but has clinical advantages to speed emergence and return of protective airway reflexes compared with sevoflurane. We hypothesized that weaning of the inspired sevoflurane during the final 15 minutes of surgery would eliminate differences in airway reflex recovery between these agents. METHODS After obtaining IRB approval and informed consent, 40 patients undergoing elective surgery (≥1-hour) randomly received desflurane or sevoflurane. Patients swallowed 20 mL of water without drooling or coughing, and then received sedation and PONV pre-medication. Anesthesia was induced using propofol and fentanyl and maintained with desflurane or sevoflurane through a laryngeal mask airway maintaining a bispectral index of 45-50 and 50-60 during the final 15 minutes before surgery end. Cardiorespiratory variables and age-adjusted minimal alveolar concentration were recorded. The duration between anesthetic discontinuation and first appropriate response to command was measured; the laryngeal mask airway was removed. Two minutes after responding to command, patients were positioned semi-upright and attempted to swallow water. If successful swallowing was not achieved, the test was repeated every 4 minutes after each failure until successful swallowing was achieved. RESULTS Average anesthetic concentration and bispectral index was similar in patients receiving desflurane vs sevoflurane. Response times after discontinuation of anesthetics were similar. There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups. CONCLUSION Weaning of sevoflurane during the final 15 minutes of surgery eliminates clinical advantages of the more rapid return of airway reflexes with desflurane.",2020,"There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups. ","['Patients swallowed 20 ml of water without drooling or coughing, and then received sedation and PONV premedication', 'After obtaining IRB approval and informed consent', 'patients undergoing elective surgery', '40 patients undergoing elective surgery (≥1-hour) randomly received']","['desflurane or sevoflurane', 'propofol and fentanyl and maintained with desflurane or sevoflurane', 'desflurane', 'Desflurane', 'sevoflurane anesthesia', 'sevoflurane']","['Cardiorespiratory variables and age-adjusted minimal alveolar concentration', 'airway reflex recovery', 'recovery of swallowing ability', 'anesthetic concentration and bispectral index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0013132', 'cui_str': 'Drooling'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]",40.0,0.0590172,"There were no differences in the recovery of swallowing ability between desflurane and sevoflurane groups. ","[{'ForeName': 'Shahbaz R', 'Initials': 'SR', 'LastName': 'Arain', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Sherman', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dugan', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pagel', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ebert', 'Affiliation': 'Anesthesia Service, The Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13565'] 3346,2666662,Acupuncture prophylaxis of cancer chemotherapy-induced sickness.,"In a multi-facet study we evaluated the efficacy of P6 electroacupuncture (10 Hz applied for 5 min) as an antiemetic in patients receiving a variety of cancer chemotherapy drugs. The study involved 130 (15 in an open pilot study, 10 in a randomized placebo controlled crossover study and 105 in a definitive study) patients who had a history of distressing sickness after previous treatment, and who, on the basis of a previous survey, would be expected to have a 96% chance of this with subsequent therapy. Sickness was either completely absent or reduced considerably in 97% of patients and no side effects were encountered. The limited crossover study, using a 'dummy' acupuncture (ACP) point showed that the beneficial effects were limited to the P6 point. Logistic and ethical considerations excluded the possibility of carrying out a larger placebo-controlled study. While in our hands P6 ACP was an effective antiemetic in patients having cancer chemotherapy, because of the time involved and the brevity of the action (8 h) an alternative approach to electro-ACP is required before this technique is adopted clinically.",1989,Sickness was either completely absent or reduced considerably in 97% of patients and no side effects were encountered.,"['patients receiving a variety of cancer chemotherapy drugs', 'patients having cancer chemotherapy', '130 (15 in an open pilot study, 10 in a randomized placebo controlled crossover study and 105 in a definitive study) patients who had a history of distressing sickness after previous treatment, and who, on the basis of a previous survey, would be expected to have a 96% chance of this with subsequent therapy', 'cancer chemotherapy-induced sickness']","['Acupuncture prophylaxis', ""dummy' acupuncture (ACP"", 'P6 electroacupuncture']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]",[],,0.0303108,Sickness was either completely absent or reduced considerably in 97% of patients and no side effects were encountered.,"[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Dundee', 'Affiliation': ""Department of Anaesthetics, Queen's University of Belfast.""}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Ghaly', 'Affiliation': ''}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Fitzpatrick', 'Affiliation': ''}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Abram', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Lynch', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3347,31351869,"Palbociclib and cetuximab in platinum-resistant and in cetuximab-resistant human papillomavirus-unrelated head and neck cancer: a multicentre, multigroup, phase 2 trial.","BACKGROUND Most head and neck squamous-cell carcinomas (HNSCCs) are driven by p16 INK4A inactivation and cyclin D1 overexpression that results in hyperactivation of cyclin-dependent kinase 4 and 6 (CDK4/6), rather than by the human papillomavirus (HPV). Deregulated cyclin D1 expression also causes resistance to EGFR inhibitors. We previously reported that palbociclib (a selective CDK4/6 inhibitor) given with cetuximab (an EGFR inhibitor) was safe. The aim of this study was to establish the proportion of patients achieving an objective response with palbociclib and cetuximab in recurrent or metastatic HNSCC. METHODS We did a multicentre, multigroup, phase 2 trial to evaluate the activity of palbociclib and cetuximab in platinum-resistant (group 1) and cetuximab-resistant (group 2) HPV-unrelated HNSCC. The study was done across eight university sites in the USA. Eligibility required measurable disease (according to Response Evaluation Criteria in Solid Tumors, version 1·1 [RECIST 1·1]), Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, age of 18 years or older, and disease progression on platinum but cetuximab-naive (group 1) or disease progression on cetuximab (group 2). All patients received palbociclib orally (125 mg/day, on days 1-21) and intravenous cetuximab (400 mg/m 2 on cycle one, day 1, then 250 mg/m 2 once per week) in 28-day cycles. The primary endpoint was objective response (complete responses and partial responses per RECIST 1·1). Analyses were done per protocol. This trial was registered with ClinicalTrials.gov, NCT02101034, and is ongoing, but both groups are closed to accrual. FINDINGS Between Oct 19, 2015, and Nov 7, 2018, 62 patients were enrolled onto the trial: 30 patients were enrolled in group 1 and 32 in group 2. Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months (4·3-8·3) for group 2. In group 1, of 28 evaluable patients, an objective response was achieved by 11 (39%; 95% CI 22-59). In group 2, of 27 evaluable patients, an objective response was achieved by five (19%; 6-38) in group 2. The most common grade 3-4 palbociclib-related adverse event was neutropenia (in 21 [34%] of 62 patients). No treatment-related deaths occurred. INTERPRETATION In patients with platinum-resistant or cetuximab-resistant HPV-unrelated HNSCC, palbociclib and cetuximab results in promising activity outcomes. Further studies of CDK4/6 inhibitors are warranted in HPV-unrelated HNSCC. FUNDING Pfizer.",2019,Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months,"['Most head and neck squamous-cell carcinomas (HNSCCs', 'Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, age of 18 years or older, and disease progression on platinum but cetuximab-naive (group 1) or disease progression on cetuximab (group 2', '30 patients were enrolled in group 1 and 32 in group 2', 'patients with platinum-resistant or cetuximab-resistant HPV-unrelated', 'in recurrent or metastatic HNSCC', 'resistant human papillomavirus-unrelated head and neck cancer', 'Between Oct 19, 2015, and Nov 7, 2018, 62 patients were enrolled onto the trial']","['Palbociclib and cetuximab', 'palbociclib and cetuximab', 'cetuximab', 'HNSCC, palbociclib and cetuximab', 'palbociclib orally', 'CDK4/6 inhibitors', 'palbociclib and cetuximab in platinum-resistant (group 1) and cetuximab-resistant (group 2) HPV-unrelated HNSCC', 'intravenous cetuximab']","['neutropenia', 'objective response', 'objective response (complete responses and partial responses per RECIST 1·1']","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]",62.0,0.0545373,Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months,"[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA. Electronic address: dadkins@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'Division of Oncology, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Assuntina G', 'Initials': 'AG', 'LastName': 'Sacco', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Department of Medicine, St Louis University, St Louis, MO, USA.'}, {'ForeName': 'Juneko E', 'Initials': 'JE', 'LastName': 'Grilley-Olson', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, and Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maggiore', 'Affiliation': 'Department of Medicine, Wilmont Cancer Institute at the University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Noha N', 'Initials': 'NN', 'LastName': 'Salama', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt; Department of Pharmaceutical and Administrative Sciences, St Louis College of Pharmacy, St Louis, MO, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Trinkaus', 'Affiliation': 'Biostatistics Shared Resource, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Conor E', 'Initials': 'CE', 'LastName': 'Steuer', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30405-X'] 3348,32057716,Rationale and protocol for a randomized controlled trial comparing daily calorie restriction versus intermittent fasting to improve glycaemia in individuals at increased risk of developing type 2 diabetes.,"BACKGROUND Intermittent fasting (IF) is proposed as a viable alternative to moderate calorie restriction (CR) for weight loss and metabolic health, but few long term randomized trials have been conducted. This protocol paper describes the rationale and detailed protocol for DIRECT study (Daily versus Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk), comparing long term effectiveness of IF versus CR on metabolic health in individuals who are at increased risk of developing type 2 diabetes. METHODS Anticipated 260 non-diabetic men and women aged 35-75 years, BMI 25-50 kg/m 2 with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator will be recruited into this open-label, multi-arm, parallel group sequential randomized controlled trial. Participants will be randomized to one of three groups for 18 months: IF (30% of energy needs on fast days), CR (70% of energy needs daily), or standard care (SC) group. All participants will visit the clinic fortnightly for weight assessments during active intervention phase (6 months), followed by a 12-month follow-up phase. IF and CR groups will receive further diet counselling by dietitian. Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization. Secondary outcomes include changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application. DISCUSSION This study will provide substantial evidence as to whether IF is an effective nutrition intervention for glycaemic control in a population at risk of developing type 2 diabetes.",2020,Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization.,"['individuals at increased risk of developing type 2 diabetes', '260 non-diabetic men and women aged 35-75 years, BMI 25-50 kg/m 2 with score ≥12 on the Australian Diabetes Risk (AUSDRISK) calculator', 'individuals who are at increased risk of developing type 2 diabetes']",['daily calorie restriction'],"['changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC', 'changes in weight, body composition via dual-energy X-ray absorptiometry, gastro-intestinal hormones, cardiovascular risk factors, and dietary record by a smartphone-based application']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",260.0,0.143915,Two primary outcomes are the changes in glycated haemoglobin (HbA1c) and postprandial glucose area under the curve (AUC) at week 24 post-randomization.,"[{'ForeName': 'Xiao Tong', 'Initials': 'XT', 'LastName': 'Teong', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vincent', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Lifelong Health Theme, South Australia Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia. Electronic address: leonie.heilbronn@adelaide.edu.au.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.01.005'] 3349,32057490,Efficacy of BPPV diagnosis and treatment system for benign paroxysmal positional vertigo.,"OBJECTIVES To evaluate the efficacy of automatic benign paroxysmal positional vertigo (BPPV) diagnosis and treatment system for BPPV compared with the manual repositioning group. METHODS Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included. Among them, 150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu) were randomly treated with BPPV diagnosis and treatment system(the experimental group) or manual repositioning (the control group). Resolution of vertigo and nystagmus on the Dix-Hallpike and Roll test on day 3,day 7,day 14 and day 28 follow-up after first treatment was the main outcome measure to assess the efficacy of treatment. RESULTS At 3-day and 7-day follow-up after treatment with BPPV diagnosis and treatment system, 79%, 91%had complete resolution of vertigo and nystagmus, the effective rate in the experimental group were significantly higher than those in the control group, the differences were statistically significant(P < .05). On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups. And at 28-day after the first treatment, the effective rate was 100% in the experimental group and the control group. The repositioning efficiency of pc-BPPV (the first, second, third treatment), hc-BPPV (the first, second, third treatment), hc-BPPV-cu(the first, second treatment) in the experimental group were higher than the control group, and the secondary reposition of pc-BPPV in the experimental group was significantly higher than the control group(96%vs.84%; P < .05). While for the hc-BPPV-cu patients, the effective rate of the third treatment in the experimental group was slightly lower than that of the control group, but the differences were not statistically significant. CONCLUSIONS BPPV diagnosis and treatment system is effective for the treatment of BPPV, with a better effective rate than those treated with manual maneuver, and is safe and easy to perform on patients.",2020,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","['150 patients of posterior semicircular canal BPPV(pc-BPPV), 53 patients of horizontal semicircular canal BPPV(hc-BPPV), and 27 patients of horizontal semicircular canal calculus (hc-BPPV-cu', 'Two hundred thirty patients diagnosed as idiopathic BPPV who were admitted from August 2018 to July 2019 in Zhejiang Hospital were included', 'benign paroxysmal positional vertigo']","['BPPV diagnosis', 'BPPV diagnosis and treatment system(the experimental group) or manual repositioning']","['effective rate', 'vertigo and nystagmus, the effective rate', 'Resolution of vertigo and nystagmus', 'repositioning efficiency of pc-BPPV', 'secondary reposition of pc-BPPV']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1288300', 'cui_str': 'Structure of posterior semicircular canal'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C0930838', 'cui_str': 'Structure of lateral semicircular canal'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0155502', 'cui_str': 'Vertigo, Benign Recurrent'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",230.0,0.0199149,"On day 14, the effective rate in the experimental group (96%) was slightly higher than that in the control group(91%), but there was no significant difference between the two groups.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liangguo', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Zhejiang Hospital, Hangzhou 310013, China. Electronic address: liuxiaoli0907@126.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102412'] 3350,31351922,"Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial.","BACKGROUND Middle East respiratory syndrome (MERS) coronavirus causes a highly fatal lower-respiratory tract infection. There are as yet no licensed MERS vaccines or therapeutics. This study (WRAIR-2274) assessed the safety, tolerability, and immunogenicity of the GLS-5300 MERS coronavirus DNA vaccine in healthy adults. METHODS This study was a phase 1, open-label, single-arm, dose-escalation study of GLS-5300 done at the Walter Reed Army Institute for Research Clinical Trials Center (Silver Spring, MD, USA). We enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS. Eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0·67 mg, 2 mg, or 6 mg GLS-5300 administered by trained clinical site staff via a single intramuscular 1 mL injection at each vaccination at baseline, week 4, and week 12 followed immediately by co-localised intramuscular electroporation. Enrolment into the higher dose groups occurred after a safety monitoring committee reviewed the data following vaccination of the first five participants at the previous lower dose in each group. The primary outcome of the study was safety, assessed in all participants who received at least one study treatment and for whom post-dose study data were available, during the vaccination period with follow-up through to 48 weeks after dose 3. Safety was measured by the incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters. The secondary outcome was immunogenicity. This trial is registered at ClinicalTrials.gov (number NCT02670187) and is completed. FINDINGS Between Feb 17 and July 22, 2016, we enrolled 75 individuals and allocated 25 each to 0·67 mg, 2 mg, or 6 mg GLS-5300. No vaccine-associated serious adverse events were reported. The most common adverse events were injection-site reactions, reported in 70 participants (93%) of 75. Overall, 73 participants (97%) of 75 reported at least one solicited adverse event; the most common systemic symptoms were headache (five [20%] with 0·67 mg, 11 [44%] with 2 mg, and seven [28%] with 6 mg), and malaise or fatigue (five [20%] with 0·67 mg, seven [28%] with 2 mg, and two [8%] with 6 mg). The most common local solicited symptoms were administration site pain (23 [92%] with all three doses) and tenderness (21 [84%] with all three doses). Most solicited symptoms were reported as mild (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg) and were self-limiting. Unsolicited symptoms were reported for 56 participants (75%) of 75 and were deemed treatment-related for 26 (35%). The most common unsolicited adverse events were infections, occurring in 27 participants (36%); six (8%) were deemed possibly related to study treatment. There were no laboratory abnormalities of grade 3 or higher that were related to study treatment; laboratory abnormalities were uncommon, except for 15 increases in creatine phosphokinase in 14 participants (three participants in the 0·67 mg group, three in the 2 mg group, and seven in the 6 mg group). Of these 15 increases, five (33%) were deemed possibly related to study treatment (one in the 2 mg group and four in the 6 mg group). Seroconversion measured by S1-ELISA occurred in 59 (86%) of 69 participants and 61 (94%) of 65 participants after two and three vaccinations, respectively. Neutralising antibodies were detected in 34 (50%) of 68 participants. T-cell responses were detected in 47 (71%) of 66 participants after two vaccinations and in 44 (76%) of 58 participants after three vaccinations. There were no differences in immune responses between dose groups after 6 weeks. At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively. INTERPRETATION The GLS-5300 MERS coronavirus vaccine was well tolerated with no vaccine-associated serious adverse events. Immune responses were dose-independent, detected in more than 85% of participants after two vaccinations, and durable through 1 year of follow-up. The data support further development of the GLS-5300 vaccine, including additional studies to test the efficacy of GLS-5300 in a region endemic for MERS coronavirus. FUNDING US Department of the Army and GeneOne Life Science.",2019,"At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively. ","['Middle East respiratory syndrome (MERS', 'enrolled healthy adults aged 18-50 years; exclusion criteria included previous infection or treatment of MERS', 'Between Feb 17 and July 22, 2016', 'healthy adults', 'Eligible participants']","['GLS-5300 MERS coronavirus DNA vaccine', 'anti-Middle East respiratory syndrome coronavirus DNA vaccine', 'GLS-5300']","['Safety and immunogenicity', 'headache', 'creatine phosphokinase', 'Seroconversion measured by S1-ELISA', 'T-cell responses', 'Neutralising antibodies', 'humoral and cellular responses', 'safety, tolerability, and immunogenicity', 'malaise or fatigue', 'Unsolicited symptoms', 'Immune responses', 'immune responses', 'immunogenicity', 'Safety', 'incidence of adverse events; administration site reactions and pain; and changes in safety laboratory parameters']","[{'cui': 'C3694279', 'cui_str': 'Middle East Respiratory Syndrome'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3698360', 'cui_str': 'Middle East respiratory syndrome-related coronavirus'}, {'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0851536', 'cui_str': 'Administration site reaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",75.0,0.238334,"At week 60, vaccine-induced humoral and cellular responses were detected in 51 (77%) of 66 participants and 42 (64%) of 66, respectively. ","[{'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Roberts', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea. Electronic address: croberts@geneonels-us.com.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'ICON Clinical Research Management, Gaithersburg, MD, USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Castellano', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Paolino', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kar', 'Initials': 'K', 'LastName': 'Muthumani', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Reuschel', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Racine', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Lamarre', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Faraz I', 'Initials': 'FI', 'LastName': 'Zaidi', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Sagar B', 'Initials': 'SB', 'LastName': 'Kudchodkar', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Moonsup', 'Initials': 'M', 'LastName': 'Jeong', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Darden', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Scott', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Remigio', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Ajay P', 'Initials': 'AP', 'LastName': 'Parikh', 'Affiliation': 'Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Megan C', 'Initials': 'MC', 'LastName': 'Wise', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Duperret', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin Y', 'Initials': 'KY', 'LastName': 'Kim', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Hyeree', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bagarazzi', 'Affiliation': 'Inovio Pharmaceuticals, Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jeanine M', 'Initials': 'JM', 'LastName': 'May', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kane', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Hyojin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kobinger', 'Affiliation': 'Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Weiner', 'Affiliation': 'Wistar Institute, Philadelphia, PA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute for Research, Silver Spring, MD, USA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Maslow', 'Affiliation': 'GeneOne Life Science, Seoul, South Korea.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30266-X'] 3351,2507782,Intra-abdominal adhesions and their prevention by topical tissue plasminogen activator.,"Recent work shows that a common pathway in adhesion production is a reduction in local plasminogen activator activity (PAA). This deficit permits deposited surface fibrin to become organized to fibrous adhesions. A rabbit model for adhesion formation was used to assess the effect of replacing the deficit with recombinant tissue plasminogen activator (rt-PA). Adhesions were produced by stripping peritoneum from corresponding parietal and visceral areas. One week later the adhesions were divided. Either rt-PA or placebo was applied to the divided adhesion. After a further week the animal was killed and the adhesions assessed. Sixty strips were performed. Fifty-five adhesions were produced (92%). Placebo gel was applied to 28 sides and rt-PA applied to 27. Twenty-two of the placebo group recurred (79%). Two of the rt-PA group reformed (7%, chi 2 = 20.883, P less than 0.001). Recombinant tissue plasminogen activator is an effective inhibitor of adhesion formation in the experimental animal.",1989,"Two of the rt-PA group reformed (7%, chi 2 = 20.883, P less than 0.001).",[],"['topical tissue plasminogen activator', 'placebo', 'Recombinant tissue plasminogen activator', 'Placebo gel', 'recombinant tissue plasminogen activator (rt-PA']",[],[],"[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]",[],55.0,0.0292046,"Two of the rt-PA group reformed (7%, chi 2 = 20.883, P less than 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Department of Surgery, Westminster Hospital, London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ellis', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3352,2027146,Non-invasive stimulation of the P6 (Neiguan) antiemetic acupuncture point in cancer chemotherapy.,"The beneficial effects of transcutaneous electrical stimulation of the P6 antiemetic point (Neiguan) as an adjuvant to standard antiemetics was studied in over 100 patients in whom chemotherapy-induced sickness was not adequately controlled by antiemetics alone. Although the results were not quite as good as with invasive acupuncture, more than 75% patients achieved considerable benefit from what was a non-toxic procedure. The use of large diffuse low impedence electrodes simplifies the technique. The 2 hourly application of Sea Bands prolongs the antiemetic action. Best results were obtained from the 2 hourly self-administration of 5 min of transcutaneous electrical stimulation of P6 using a simple battery-operated TENS machine (15 Hz) to activate a large, easy-to-place surface electrode and increasing current until Qi is elicited.",1991,The beneficial effects of transcutaneous electrical stimulation of the P6 antiemetic point (Neiguan) as an adjuvant to standard antiemetics was studied in over 100 patients in whom chemotherapy-induced sickness was not adequately controlled by antiemetics alone.,['100 patients in whom chemotherapy-induced sickness was not adequately controlled by antiemetics alone'],"['transcutaneous electrical stimulation of the P6 antiemetic point (Neiguan', 'P6 (Neiguan) antiemetic acupuncture']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.020367,The beneficial effects of transcutaneous electrical stimulation of the P6 antiemetic point (Neiguan) as an adjuvant to standard antiemetics was studied in over 100 patients in whom chemotherapy-induced sickness was not adequately controlled by antiemetics alone.,"[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Dundee', 'Affiliation': ""Northern Ireland Radiotherapy and Oncology Centre, Queen's University of Belfast.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McMillan', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3353,2118572,Day-case surgery: enhanced recovery with flumazenil.,"In an open, randomized, parallel group study of 84 adult patients undergoing elective day-case urological surgery the specific benzodiazepine antagonist flumazenil was shown to reverse effectively subjective postoperative sedation due to midazolam and enabled 83% of patients to recover and be ready for potential discharge within 15 min of surgery (control group 24% p less than 0.001). The significantly shorter recovery time has benefits in terms of increased patient cooperation and reduced demands on postoperative nursing care. The implications of these findings for day-case surgery are discussed.",1990,The significantly shorter recovery time has benefits in terms of increased patient cooperation and reduced demands on postoperative nursing care.,['84 adult patients undergoing elective day-case urological surgery the'],"['flumazenil', 'midazolam', 'specific benzodiazepine antagonist flumazenil']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]",[],84.0,0.0234408,The significantly shorter recovery time has benefits in terms of increased patient cooperation and reduced demands on postoperative nursing care.,"[{'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Birch', 'Affiliation': 'Department of Minimally Invasive Surgery, Royal Northern Hospital, London.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Anson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Clifford', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Miller', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3354,2181138,Postoperative nausea is relieved by acupressure.,"One hundred and sixty-two general surgical patients were prospectively randomized to one of three treatments for postoperative nausea and vomiting: (1) acupressure using elasticated bands containing a plastic button to apply sustained pressure at the P6 (Neiguan) point above the wrist, (2) control dummy bands without the pressure button and (3) antiemetic injections of prochlorperazine with each opiate given and as required. All patients received papaveretum injections as required for pain, and additional prochlorperazine injections were prescribed if nausea was not controlled in groups 1 and 2. The severity of nausea was assessed using a linear analogue scale and was significantly (P = 0.002) reduced by acupressure on both days 1 and 2, in comparison to both controls and drug treated patients. The incidence of postoperative vomiting, and the need for unplanned antiemetic injections was also reduced by acupressure but this was not statistically significant. Acupressure can work and should be investigated in other clinical situations.",1990,"The incidence of postoperative vomiting, and the need for unplanned antiemetic injections was also reduced by acupressure but this was not statistically significant.",['One hundred and sixty-two general surgical patients'],"['prochlorperazine injections', 'Acupressure', 'papaveretum injections', 'acupressure using elasticated bands containing a plastic button to apply sustained pressure at the P6 (Neiguan) point above the wrist, (2) control dummy bands without the pressure button and (3) antiemetic injections of prochlorperazine']","['postoperative nausea and vomiting', 'nausea', 'incidence of postoperative vomiting, and the need for unplanned antiemetic injections', 'severity of nausea', 'Postoperative nausea']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4255059', 'cui_str': 'Prochlorperazine Injection'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0030349', 'cui_str': 'Papaveretum'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520905', 'cui_str': 'Postoperative Emesis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}]",162.0,0.0403099,"The incidence of postoperative vomiting, and the need for unplanned antiemetic injections was also reduced by acupressure but this was not statistically significant.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Barsoum', 'Affiliation': 'Department of Surgery, Walsgrave General Hospital, Coventry.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Perry', 'Affiliation': ''}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Fraser', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3355,32044319,Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease.,"BACKGROUND & AIMS We evaluated the efficacy and safety of upadacitinib, an oral selective Janus kinase 1 inhibitor, in a randomized trial of patients with Crohn's disease (CD). METHODS We performed a double-blind, phase 2 trial in adults with moderate to severe CD and inadequate response or intolerance to immunosuppressants or tumor necrosis factor antagonists. Patients were randomly assigned (1:1:1:1:1:1) to groups given placebo; or 3 mg, 6 mg, 12 mg, or 24 mg upadacitinib twice daily; or 24 mg upadacitinib once daily and were evaluated by ileocolonoscopy at weeks 12 or 16 of the induction period. Patients who completed week 16 were re-randomized to a 36-week period of maintenance therapy with upadacitinib. The primary endpoints were clinical remission at week 16 and endoscopic remission at week 12 or 16 using the multiple comparison procedure and modeling and the Cochran-Mantel-Haenszel test, with a 2-sided level of 10%. RESULTS Among the 220 patients in the study, clinical remission was achieved by 13% of patients receiving 3 mg upadacitinib, 27% of patients receiving 6 mg upadacitinib (P < .1 vs placebo), 11% of patients receiving 12 mg upadacitinib, and 22% of patients receiving 24 mg upadacitinib twice daily, and by 14% of patients receiving 24 mg upadacitinib once daily, vs 11% of patients receiving placebo. Endoscopic remission was achieved by 10% (P < .1 vs placebo), 8%, 8% (P < .1 vs placebo), 22% (P < .01 vs placebo), and 14% (P < .05 vs placebo) of patients receiving upadacitinib, respectively, vs none of the patients receiving placebo. Endoscopic but not clinical remission increased with dose during the induction period. Efficacy was maintained for most endpoints through week 52. During the induction period, patients in the upadacitinib groups had higher incidences of infections and serious infections vs placebo. Patients in the twice-daily 12 mg and 24 mg upadacitinib groups had significant increases in total, high-density lipoprotein, and low-density lipoprotein cholesterol levels compared with patients in the placebo group. CONCLUSIONS In a phase 2 trial of patients with CD, upadacitinib induced endoscopic remission in a significant proportion of patients compared with placebo. Upadacitinib's benefit/risk profile supports further development for treatment of CD. (Clinicaltrials.gov, Number: NCT02365649).",2020,"During the induction period, patients in the upadacitinib groups had higher incidences of infections and serious infections versus placebo.","[""Patients With Crohn's Disease"", 'adults with moderate to severe CD and inadequate response or intolerance to immunosuppressants or tumor necrosis factor antagonists', ""patients with Crohn's disease (CD""]","['maintenance therapy with upadacitinib', 'placebo']","['endoscopic remission', 'total, high-density lipoprotein, and low-density lipoprotein cholesterol', 'clinical remission at week 16 and endoscopic remission', 'clinical remission', 'Efficacy and Safety', 'Efficacy', 'infections and serious infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",220.0,0.295869,"During the induction period, patients in the upadacitinib groups had higher incidences of infections and serious infections versus placebo.","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': ""Western University, Robarts Clinical Trials, St Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology and Inserm U1256 Nutrition-Génétique et Exposition aux Risques Environnementaux, niversity of Lorraine, Nancy, France.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Van Assche', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology, Amsterdam University Medical Center campus Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'University of Birmingham, National Institute for Health Research Biomedical Research Centre, Birmingham, United Kingdom.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Scherl', 'Affiliation': 'Weill Department of Medicine, New York Presbyterian Hospital Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Herfarth', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Vitale', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Bidan', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Roopal B', 'Initials': 'RB', 'LastName': 'Thakkar', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Lacerda', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panes', 'Affiliation': 'Inflammatory Bowel Diseases Unit, Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. Electronic address: JPANES@clinic.cat.'}]",Gastroenterology,['10.1053/j.gastro.2020.01.047'] 3356,31876036,Does a regular nurse-led distress screening and discussion improve quality of life of breast cancer patients treated with curative intent? A randomized controlled trial.,"OBJECTIVE We performed a randomized controlled trial (RCT) to investigate whether regular screening with the distress thermometer (DT) by a nurse improved global quality of life (QOL) of patients with breast cancer (BC) treated with curative intent. METHODS BC patients were randomized between regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC). Both groups filled out questionnaires at baseline, after each received treatment modality and at follow-up visits up to 2 years. At these points, the intervention group received also the NDTI. The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after the end of treatment. Analyses were done on an intention-to-treat basis, using analysis of covariance (ANCOVA), generalized least squares, and interaction analyses. RESULTS Of 194 randomized patients, 153 filled out the questionnaires up to 2 years after treatment. There was no significant difference between NDTI and UC in global QOL 2 years after the end of treatment (mean diff. = -1∙273, P = .610; 95% CI [-6.195; 3.649]). Subgroup analysis of patients who received multimodality treatment (surgery, radiotherapy, and chemotherapy, n = 66) showed a significant between-group difference in global QOL over time (mean diff. = -10, P < .001; 95% CI [-14.835; -5.167]) together with other secondary outcome measures in favor of the NDTI. CONCLUSION NDTI did not lead to a significant improvement in global QOL 2 years after the end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment may benefit from NDTI.",2020,The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after end of treatment.,"['breast cancer patients treated with curative intent', '194 randomized patients', 'patients with breast cancer (BC) treated with curative intent', 'BC patients']","['regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC', 'regular nurse-led distress screening and discussion', 'multimodality treatment (surgery, radiotherapy, and chemotherapy', 'regular screening with the DT']","['global QOL of the EORTC QLQ C30', 'quality of life', 'NDTI and UC in global QOL', 'global QOL']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}]",194.0,0.100054,The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after end of treatment.,"[{'ForeName': 'Floortje K', 'Initials': 'FK', 'LastName': 'Ploos van Amstel', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marlies E W J', 'Initials': 'MEWJ', 'LastName': 'Peters', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Margrethe S', 'Initials': 'MS', 'LastName': 'Schlooz-Vries', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lenny J M', 'Initials': 'LJM', 'LastName': 'Polman', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Judith B', 'Initials': 'JB', 'LastName': 'Prins', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5324'] 3357,31620931,Pertuzumab plus trastuzumab and chemotherapy for Japanese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer: a subgroup analysis of the JACOB trial.,"BACKGROUND The phase III JACOB trial (NCT01774786) compared the efficacy and safety of pertuzumab and trastuzumab plus chemotherapy with placebo and trastuzumab plus chemotherapy in patients with previously untreated human epidermal growth factor receptor 2 (HER2)-positive metastatic gastric or gastroesophageal junction cancer. We conducted a subgroup analysis in Japanese patients. METHODS Patients were randomized 1:1 to pertuzumab 840 mg or placebo, plus trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) and chemotherapy (cisplatin 80 mg/m 2 , and capecitabine 1000 mg/m 2 twice daily for 28 doses or 5-fluorouracil 800 mg/m 2 every 24 h for 120 h), every 3 weeks. Continuation of chemotherapy after 6 cycles was at the discretion of the patient and the treating physician. RESULTS A total of 40 Japanese patients were included in each arm. Median overall survival was 22.0 months (95% confidence interval [CI] 13.8-not evaluable) and 15.6 months (95% CI 9.7-19.2) in the pertuzumab and placebo arms, respectively (hazard ratio [HR] 0.64 [95% CI 0.37-1.10]). Median progression-free survival was 12.4 months (95% CI 6.1-14.1) in the pertuzumab arm and 6.3 months (95% CI 4.3-8.1) in the placebo arm (HR 0.50 [95% CI 0.30-0.82]). Grade ≥ 3 adverse events and serious adverse events were more frequent in the pertuzumab arm than the placebo arm. CONCLUSIONS Results from this subgroup analysis of the JACOB trial suggest similar efficacy of pertuzumab in Japanese patients and patients in the overall population, encouraging continued investigation of new agents for gastric cancer in Japanese patients.",2020,"Median overall survival was 22.0 months (95% confidence interval [CI] 13.8-not evaluable) and 15.6 months (95% CI 9.7-19.2) in the pertuzumab and placebo arms, respectively (hazard ratio [HR] 0.64","['Patients', '40 Japanese patients', 'Japanese patients', 'patients with previously untreated human epidermal growth factor receptor 2 (HER2)-positive metastatic gastric or gastroesophageal junction cancer', 'Japanese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer', 'Japanese patients and patients in the overall population']","['pertuzumab 840\xa0mg or placebo, plus trastuzumab (loading dose, 8\xa0mg/kg; maintenance dose, 6\xa0mg/kg) and chemotherapy (cisplatin 80', '5-fluorouracil 800', 'chemotherapy', 'pertuzumab and trastuzumab plus chemotherapy with placebo and trastuzumab plus chemotherapy', 'placebo', 'Pertuzumab plus trastuzumab and chemotherapy', 'capecitabine']","['Grade\u2009≥\u20093 adverse events and serious adverse events', 'Median progression-free survival', 'Median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",40.0,0.662475,"Median overall survival was 22.0 months (95% confidence interval [CI] 13.8-not evaluable) and 15.6 months (95% CI 9.7-19.2) in the pertuzumab and placebo arms, respectively (hazard ratio [HR] 0.64","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. kshitara@east.ncc.go.jp.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina, Saitama, 362-0806, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakano, Asahi-ku, Yokohama, 241-8515, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, 3-1-56 Bandaihigashi Sumiyoshi-ku, Osaka, 558-8558, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou-160, Minamiumemoto-machi, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asakawa', 'Affiliation': 'Clinical Information and Intelligence Department, Chugai Pharmaceutical Co., Ltd, 2-1-1, Nihonbashi-Muromachi, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Satoe', 'Initials': 'S', 'LastName': 'Kawakami', 'Affiliation': 'Clinical Science & Strategy Department, Chugai Pharmaceutical Co., Ltd, 2-1-1, Nihonbashi-Muromachi Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-019-01558-z'] 3358,31949042,Scheduled afternoon-evening sleep leads to better night shift performance in older adults.,"OBJECTIVES This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. METHODS Non-shift workers aged 57.9±4.6 (mean±SD) worked four day (07:00-15:00) and four night shifts (23:00-07:00). Two intervention groups were instructed to remain awake until ~13:00 after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8 hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions. A control group (n=9) from our previous study was not given any sleep instructions. Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance. RESULTS The ST group maintained their day shift sleep durations on night shifts, whereas the control group slept less. The ST group were able to maintain stable performance and alertness across the initial part of the night shift, while the control group's alertness and performance declined across the entire night. Wake duration before a night shift negatively impacted sustained attention and self-reported sleepiness but not reaction time, whereas sleep duration before a night shift affected reaction time and ability to sustain attention but not self-reported sleepiness. CONCLUSIONS A behavioural change under the control of the individual worker, spending 8 hours in bed and waking close to the start of the night shift, allowed participants to acquire more sleep and improved performance on the night shift in older adults. Both sleep duration and timing are important factors for night shift performance and self-reported sleepiness.",2020,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. ","['Non-shift workers aged 57.9±4.6 (mean±SD) worked four\u2009day (07:00-15:00) and four night shifts (23:00-07:00', 'older adults']","['remain awake until ~13:00\u2009after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8\u2009hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions']","['homeostatic sleep pressure', 'Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.00963091,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults. ","[{'ForeName': 'Cheryl Martine', 'Initials': 'CM', 'LastName': 'Isherwood', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Chinoy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Audra S', 'Initials': 'AS', 'LastName': 'Murphy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jeanne F', 'Initials': 'JF', 'LastName': 'Duffy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA jduffy@research.bwh.harvard.edu.""}]",Occupational and environmental medicine,['10.1136/oemed-2019-105916'] 3359,32056061,"The Effect of Emotion Regulation Training on Stress, Anxiety, and Depression in Family Caregivers of Patients with Schizophrenia: A Randomized Controlled Trial.","Schizophrenia is the most severe chronic disabling psychiatric disorder that needs long term care in various aspects. Therefore, the family's emotional atmosphere caused by the disease affects the condition of the patients' caregivers. This study aimed to investigate the effect of emotional regulation training on stress, anxiety, and depression in caregivers of patients with schizophrenia. The study was a randomized controlled trial. Seventy caregivers of patients with schizophrenia randomly assigned to a group that received emotion regulation training and a control group. The intervention group was trained about emotion regulation during eight 90-min sessions. The participants completed the Depression, Anxiety and Stress Scales-21 questionnaire before and one month after the intervention. The results showed that stress, anxiety and depression scores significantly reduced in the intervention group compared to the control group. Emotional regulation training with cognitive methods has significantly reduced the anxiety, stress, and depression of caregivers of patients with schizophrenia.",2020,"The results showed that stress, anxiety and depression scores significantly reduced in the intervention group compared to the control group.","['Family Caregivers of Patients with Schizophrenia', 'Seventy caregivers of patients with schizophrenia', 'caregivers of patients with schizophrenia']","['Emotional regulation training with cognitive methods', 'Emotion Regulation Training', 'emotional regulation training', 'emotion regulation training and a control group']","['stress, anxiety and depression scores', 'stress, anxiety, and depression', 'Depression, Anxiety and Stress Scales-21 questionnaire', 'anxiety, stress, and depression of caregivers', 'Stress, Anxiety, and Depression']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",70.0,0.0282046,"The results showed that stress, anxiety and depression scores significantly reduced in the intervention group compared to the control group.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Behrouian', 'Affiliation': 'Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Ramezani', 'Affiliation': 'Department of Public Health, Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Department of Critical Care, Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran. m_dehghan86@yahoo.com.'}, {'ForeName': 'Abdoreza', 'Initials': 'A', 'LastName': 'Sabahi', 'Affiliation': 'Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Ebrahimnejad Zarandi', 'Affiliation': 'Shaheed Beheshti Medical Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Community mental health journal,['10.1007/s10597-020-00574-y'] 3360,31353413,"Investigating the Effects of Spacing on Working Memory Training Outcome: A Randomized, Controlled, Multisite Trial in Older Adults.","OBJECTIVE The majority of the population will experience some cognitive decline with age. Therefore, the development of effective interventions to mitigate age-related decline is critical for older adults' cognitive functioning and their quality of life. METHODS In our randomized controlled multisite trial, we target participants' working memory (WM) skills, and in addition, we focus on the intervention's optimal scheduling in order to test whether and how the distribution of training sessions might affect task learning, and ultimately, transfer. Healthy older adults completed an intervention targeting either WM or general knowledge twice per day, once per day, or once every-other-day. Before and after the intervention and 3 months after training completion, participants were tested in a variety of cognitive domains, including those representing functioning in everyday life. RESULTS In contrast to our hypotheses, spacing seems to affect learning only minimally. We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up. DISCUSSION Our findings have practical implications by showing that the variation in training schedule, at least within the range used here, does not seem to be a crucial element for training benefits.",2020,"We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up. ","['older adults', 'Healthy older adults', ""participants' working memory (WM) skills""]",[],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",[],[],,0.0577707,"We did observe some transfer effects, especially within the targeted cognitive domain (WM and inhibition/interference), which remained stable at the 3-month follow-up. ","[{'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'School of Education, University of California, Irvine.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Buschkuehl', 'Affiliation': 'MIND Research Institute, Irvine, California.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Parlett-Pelleriti', 'Affiliation': 'Schmid College of Science and Technology, Chapman University, Orange, California.'}, {'ForeName': 'Seung Min', 'Initials': 'SM', 'LastName': 'Moon', 'Affiliation': 'School of Education, University of California, Irvine.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kritzmacher', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Reuter-Lorenz', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jonides', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz090'] 3361,2213800,Comparison of a dimethicone/antacid (Asilone gel) with an alginate/antacid (Gaviscon liquid) in the management of reflux oesophagitis.,"Fifty-three patients with symptomatic reflux oesophagitis were entered into a single centre randomized study comparing the effects of a dimethicone/antacid (Asilone Gel) and an alginate/antacid (Gaviscon liquid) on symptoms and endoscopic changes over an 8-week period. Both treatments significantly improved heartburn, acid regurgitation and flatulence. Dimethicone/antacid but not alginate/antacid, produced a significant improvement in oesophagitis, oesophageal ulceration and histological grade of inflammation over the 8-week treatment period so that 14 patients treated with dimethicone/antacid and 10 with alginate/antacid had normal endoscopic oesophageal appearances at the end of the study. The difference in improvement between the two patient groups did not reach significance however, except for dimethicone/antacid improving histological changes (P less than 0.05). These findings suggest that dimethicone/antacid and alginate/antacid are equally effective in treating symptomatic reflux oesophagitis although dimethicone/antacid may have an advantage in improving oesophageal histological appearances.",1990,"Dimethicone/antacid but not alginate/antacid, produced a significant improvement in oesophagitis, oesophageal ulceration and histological grade of inflammation over the 8-week treatment period so that 14 patients treated with dimethicone/antacid and 10 with alginate/antacid had normal endoscopic oesophageal appearances at the end of the study.",['Fifty-three patients with symptomatic reflux oesophagitis'],"['dimethicone/antacid (Asilone Gel) and an alginate/antacid (Gaviscon liquid', 'dimethicone/antacid', 'Dimethicone/antacid', 'alginate/antacid', 'dimethicone/antacid and alginate/antacid', 'dimethicone/antacid (Asilone gel) with an alginate/antacid (Gaviscon liquid']","['oesophagitis, oesophageal ulceration and histological grade of inflammation', 'histological changes', 'reflux oesophagitis', 'normal endoscopic oesophageal appearances', 'heartburn, acid regurgitation and flatulence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}]","[{'cui': 'C1113707', 'cui_str': 'dimeticone'}, {'cui': 'C0003138', 'cui_str': 'Alkalinizing Agents'}, {'cui': 'C0052507', 'cui_str': 'Asilone'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0151970', 'cui_str': 'Ulcer of esophagus (disorder)'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",53.0,0.012548,"Dimethicone/antacid but not alginate/antacid, produced a significant improvement in oesophagitis, oesophageal ulceration and histological grade of inflammation over the 8-week treatment period so that 14 patients treated with dimethicone/antacid and 10 with alginate/antacid had normal endoscopic oesophageal appearances at the end of the study.","[{'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Smart', 'Affiliation': 'Department of Medicine, University of Sheffield, Royal Hallamshire Hospital.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3362,31355898,Effect of Self-Acupoint Massage on Blood Glucose Level and Quality of Life in Older Adults With Type 2 Diabetes Mellitus: A Randomized Controlled Trial.,"The current study aimed to explore the effect of self-acupoint massage (SEAM) on blood glucose level and quality of life in community-dwelling older adults with type 2 diabetes mellitus (T2DM). Sixty-six older adults with T2DM were enrolled and randomly divided into observation and control groups. Participants in the control group received routine nursing interventions, whereas participants in the observation group received a SEAM intervention in addition to routine nursing interventions. After 12 weeks of SEAM, glycosylated hemoglobin (HbA1c) levels in the observation group decreased from 8.35% (SD = 1.84%) at baseline to 7.29% (SD = 1.38%) (p < 0.01). Total score of the Diabetes-Specific Quality of Life Scale (DSQLS) in the observation group improved from 45.96 (SD = 4.29) at baseline to 41.3 (SD = 3.89) (p < 0.01). The physiological dimension of the DSQLS in the observation group improved from 49.65 (SD = 7.33) at baseline to 38.54 (SD = 4.68) (p < 0.01). As SEAM effectively decreased older adults' HbA1c level and improved their quality of life, it can be used as a complementary approach to routine nursing interventions for community-dwelling older adults with T2DM. [Journal of Gerontological Nursing, 45(8), 43-48.].",2019,Total score of the Diabetes-Specific Quality of Life Scale (DSQLS) in the observation group improved from 45.96 (SD = 4.29) at baseline to 41.3 (SD = 3.89) (p < 0.01).,"['2 Diabetes Mellitus', 'Sixty-six older adults with T2DM', 'Older Adults With Type', 'community-dwelling older adults with T2DM', 'community-dwelling older adults with type 2 diabetes mellitus (T2DM']","['SEAM intervention in addition to routine nursing interventions', 'self-acupoint massage (SEAM', 'routine nursing interventions', 'Self-Acupoint Massage']","['Total score of the Diabetes-Specific Quality of Life Scale (DSQLS', ""older adults' HbA1c level"", 'quality of life', 'blood glucose level and quality of life', 'physiological dimension of the DSQLS', 'Blood Glucose Level and Quality of Life', 'glycosylated hemoglobin (HbA1c) levels']","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",66.0,0.0317801,Total score of the Diabetes-Specific Quality of Life Scale (DSQLS) in the observation group improved from 45.96 (SD = 4.29) at baseline to 41.3 (SD = 3.89) (p < 0.01).,"[{'ForeName': 'Wei-Bo', 'Initials': 'WB', 'LastName': 'Lyu', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Kang-Yao', 'Initials': 'KY', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Wen-Qin', 'Initials': 'WQ', 'LastName': 'Zhou', 'Affiliation': ''}]",Journal of gerontological nursing,['10.3928/00989134-20190709-05'] 3363,31928489,Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study.,"Purpose: Among cancer survivors, physical activity (PA) is associated with reductions in cancer recurrence, morbidity, and mortality. Most young adult (YA) survivors do not attain adequate PA. Digital modalities, specifically wearable activity monitors with a paired mobile application and private social media group for support offer a promising approach for promoting PA among YAs. We conducted a pilot randomized controlled trial of this intervention. To evaluate its acceptability and perceptions of the intervention components, we conducted qualitative interviews with those in the intervention. The results of our interviews serve to refine future interventions to better serve this population. Methods: Semistructured qualitative interviews with 13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor. Analyses included a qualitative thematic analysis of the interview transcripts and coded interview segments into three predetermined categories: facilitators, limitations, and suggestions. Results: Participants described wide-ranging benefits of the intervention, citing the Fitbit device and buddy system as major motivators to engage in PA and reach goals. Most participants noted feelings of increased physical and emotional wellness. The most-cited limitation of the intervention was the automated text messages, which participants found impersonal. Suggestions for improvement included integrating more elements of competition and group challenges. Conclusion: This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life. Clinicaltrial.gov identifier number: NCT03233581; Date of registration: July 28, 2017.",2020,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"['13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor', 'Young Adult Cancer Survivors', 'Clinicaltrial.gov identifier number', 'Most young adult ']","['Fitbit and Facebook Intervention', 'digital PA intervention']","['cancer recurrence, morbidity, and mortality', 'feelings of increased physical and emotional wellness']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0607168,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"[{'ForeName': 'Evelina M', 'Initials': 'EM', 'LastName': 'Miropolsky', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Scott Baker', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ceballos', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2019.0072'] 3364,31971325,Mindfetalness to increase women's awareness of fetal movements and pregnancy outcomes: a cluster-randomised controlled trial including 39 865 women.,"OBJECTIVE To examine whether a method for raising women's awareness of fetal movements, Mindfetalness, can affect pregnancy outcomes. DESIGN Cluster-randomised controlled trial. SETTING Sixty-seven maternity clinics in Stockholm, Sweden. POPULATION Women with singleton pregnancy with birth from 32 weeks' gestation. METHODS Women registered at a clinic randomised to Mindfetalness were assigned to receive a leaflet about Mindfetalness (n = 19 639) in comparison with routine care (n = 20 226). Data were collected from a population-based register. MAIN OUTCOME MEASURES Apgar score <7 at 5 minutes after birth, visit to healthcare due to decrease in fetal movements. Other outcomes: Apgar score <4 at 5 minutes after birth, small-for-gestational-age and mode of delivery. RESULTS No difference (1.1 versus 1.1%, relative risk [RR] 1.0; 95% CI 0.8-1.2) was found between the Mindfetalness group and the Routine care group for a 5-minute Apgar score <7. Women in the Mindfetalness group contacted healthcare more often due to decreased fetal movements (6.6 versus 3.8%, RR 1.72; 95% CI 1.57-1.87). Mindfetalness was associated with a reduction of babies born small-for-gestational-age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41 +6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0 versus 20.0%, RR 0.95; 95% CI 0.91-0.99). CONCLUSIONS Mindfetalness did not reduce the number of babies born with an Apgar score <7. However, Mindfetalness was associated with the health benefits of decreased incidence of caesarean section and fewer children born small-for-gestational-age. TWEETABLE ABSTRACT Introducing Mindfetalness in maternity care decreased caesarean sections but had no effect on the occurrence of Apgar scores <7.",2020,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99). ","['39\xa0865 women', 'Women registered at a clinic randomised to Mindfetalness', ""Women with singleton pregnancy with birth from 32 weeks' gestation"", 'Sixty-seven maternity clinics in Stockholm, Sweden']",['leaflet about Mindfetalness (n=19\xa0639) in comparison to routine care'],"['caesarean sections', 'reduction of babies born small for gestational age', 'fetal movements', 'Rate Ratio', 'fetal movements and pregnancy outcomes', 'number of babies born with an Apgar score', 'caesarean section']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0015946', 'cui_str': 'Fetal Activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",,0.222127,"Mindfetalness was associated with a reduction of babies born small for gestational age (RR 0.95, 95% CI 0.90-1.00), babies born after gestational week 41+6 (RR 0.91, 95% CI 0.83-0.98) and caesarean sections (19.0% versus 20.0%, RR 0.95; 95% CI 0.91-0.99). ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Akselsson', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Sophiahemmet University, Stockholm, Sweden.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Georgsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, The Swedish Red Cross University College, Stockholm, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Skokic', 'Affiliation': 'Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rådestad', 'Affiliation': 'Sophiahemmet University, Stockholm, Sweden.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16104'] 3365,31873788,A single bout of resistance exercise improves postprandial lipid metabolism in overweight/obese men with prediabetes.,"AIMS/HYPOTHESIS Prediabetes is associated with postprandial hypertriacylglycerolaemia. Resistance exercise acutely lowers postprandial plasma triacylglycerol (TG); however, the changes in lipid metabolism that mediate this reduction are poorly understood. The aim of this study was to identify the constitutive metabolic mechanisms underlying the changes in postprandial lipid metabolism after resistance exercise in obese men with prediabetes. METHODS We evaluated the effect of a single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum) on postprandial lipid metabolism in ten middle-aged (50 ± 9 years), overweight/obese (BMI: 33 ± 3 kg/m 2 ), sedentary men with prediabetes (HbA 1c >38 but <48 mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6 mmol/l but <7.0 mmol/l or 2 h OGTT glucose >7.8 mmol/l but <11.1 mmol/l). We used a randomised, crossover design with a triple-tracer mixed meal test (ingested [( 13 C 4 ) 3 ]tripalmitin, i.v. [U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol) to evaluate chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics. We used adipose tissue and skeletal muscle biopsies to evaluate the expression of genes regulating lipolysis and lipid oxidation, skeletal muscle respirometry to evaluate oxidative capacity, and indirect calorimetry to assess whole-body lipid oxidation. RESULTS The single bout of resistance exercise reduced the lipaemic response to a mixed meal in obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates. However, resistance exercise reduced endogenous and meal-derived fatty acid incorporation into chylomicron-TG and TRL-TG. Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue. CONCLUSIONS/INTERPRETATION A single bout of resistance exercise improves postprandial lipid metabolism in obese men with prediabetes, which may mitigate the risk for cardiovascular disease and type 2 diabetes.",2020,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue. ","['ten middle-aged (50\u2009±\u20099\xa0years), overweight/obese (BMI: 33\u2009±\u20093\xa0kg/m 2 ), sedentary men with prediabetes (HbA 1c >38 but <48\xa0mmol/mol [>5.7% but <6.5%]), or fasting plasma glucose >5.6\xa0mmol/l but <7.0\xa0mmol/l or 2', 'obese men with prediabetes', 'overweight/obese men with prediabetes', 'obese men with prediabetes without changing chylomicron-TG or TRL-TG fractional clearance rates']","['resistance exercise', 'U- 13 C 16 ]palmitate and [ 2 H 5 ]glycerol', 'Resistance exercise', 'single bout of whole-body resistance exercise (seven exercises, three sets, 10-12 repetitions at 80% of one-repetition maximum']","['chylomicron-TG and total triacylglycerol-rich lipoprotein (TRL)-TG kinetics', 'postprandial plasma triacylglycerol (TG', 'lipaemic response', 'postprandial lipid metabolism']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.0657195,"Resistance exercise also increased whole-body lipid oxidation, skeletal muscle mitochondrial respiration, oxidative gene expression in skeletal muscle, and the expression of key lipolysis genes in adipose tissue. ","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA. bittela@wusm.wustl.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bittel', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Adewole L', 'Initials': 'AL', 'LastName': 'Okunade', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yoshino', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Lane C', 'Initials': 'LC', 'LastName': 'Porter', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Nada A', 'Initials': 'NA', 'LastName': 'Abumrad', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'W Todd', 'Initials': 'WT', 'LastName': 'Cade', 'Affiliation': 'Program in Physical Therapy, Washington University, St Louis, Campus Box 8502, 4444 Forest Park Ave., St Louis, MO, 63110, USA.'}]",Diabetologia,['10.1007/s00125-019-05070-x'] 3366,32028286,10-Day Versus 14-Day Quadruple Concomitant Nonbismuth Therapy for the Treatment of Helicobacter pylori Infection: Results From a Randomized Prospective Study in a High Clarithromycin Resistance Country.,"GOALS The aim of this study was to investigate the implementation of a 14-day quadruple nonbismuth concomitant regimen, as proposed by recent Guidelines and Consensus Statements. BACKGROUND In Greece, a region with >20% clarithromycin resistance where bismuth is unavailable, the 10-day quadruple concomitant scheme has already been adopted as the accepted first-line Helicobacter pylori eradication treatment. STUDY Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day or a 14-day nonbismuth quadruple concomitant scheme. Treatment outcome was assessed by C-urea breath test and/or histology at least 4 weeks after therapy. Intention to treat and per protocol analyses of the eradication rates were performed. Secondary endpoints included patient adherence, safety, and the impact of prior antibiotic exposure in treatment efficacy. RESULTS The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively. Both groups displayed excellent compliance rates (99.5% for the 10-day vs. 96.2% for the 14-day treatment duration, P=0.067). As regards treatment safety, serious adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the 2 groups (0.5% in the 10-day group and 2.2% in the 14-day group, P>0.05). Previous antibiotic exposure was not significant with regard to treatment efficacy. CONCLUSION In Greece, the 10-day concomitant nonbismuth quadruple regimen for first-line treatment remains the most efficient strategy for H. pylori eradication.",2020,"The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively.",['364 patients with newly diagnosed H. pylori infection'],"['10-Day Versus 14-Day Quadruple Concomitant Nonbismuth Therapy', '14-day nonbismuth quadruple concomitant scheme']","['C-urea breath test and/or histology', 'excellent compliance rates', 'patient adherence, safety, and the impact of prior antibiotic exposure in treatment efficacy', 'Helicobacter pylori Infection', 'overall eradication rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1321605', 'cui_str': 'Patient Cooperation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",364.0,0.0386715,"The overall eradication rates of the 2 treatments were 87.9% versus 87.4% in the intention to treat analysis, P=1.000, and 93% versus 94.1%, P=0.859, in the per protocol analysis for the 10-day and the 14-day treatment group, respectively.","[{'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Apostolopoulos', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Ekmektzoglou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Georgopoulos', 'Affiliation': 'Department of Gastroenterology and Hepatology, Athens Medical, Paleo Faliron Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Chounta', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Theofanopoulou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Chrisostomos', 'Initials': 'C', 'LastName': 'Kalantzis', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Erasmia', 'Initials': 'E', 'LastName': 'Vlachou', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsibouris', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Alexandrakis', 'Affiliation': 'Department of Gastroenterology, Army Share Fund Hospital (NIMTS).'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001328'] 3367,31837232,Twenty-four-hour subjective and pharmacological effects of ad-libitum electronic and combustible cigarette use among dual users.,"BACKGROUND AND AIMS Relative pharmacological effects of e-cigarettes and cigarettes during 24 hours of ad-libitum use have not been described. In this study, 24-hour blood plasma nicotine concentrations and 48-hour subjective effects with use of cigarettes and e-cigarettes were measured among dual users. DESIGN Two-arm within-subject cross-over design with preferred e-cigarette or cigarette ad-libitum use over 48 hours. SETTING Hospital research ward in San Francisco, California, USA. PARTICIPANTS Thirty-six healthy dual users of e-cigarettes and cigarettes (n = 8, 25% females). MEASUREMENTS Twenty-four-hour blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects. FINDINGS Analyses used analysis of variance (ANOVA)-based mixed models with order of product (e-cigarette or cigarette) and product type (combustible cigarette or type of e-cigarette) as fixed effects, and subject as a repeated effect. During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence. Compared to cigarette smoking, nicotine exposure for variable-power tank users was similar, while cig-a-like (t (30)  = 2.71, P = 0.011, d = 0.745) and fixed-power tank users (t (30)  = 3.37, P = 0.002, d = 0.993) were exposed to less nicotine. Cigarettes were rated higher than e-cigarettes on some desirable subjective effects (e.g. psychological reward, t (322)  = 7.24 P < 0.001, d = 0.432), but withdrawal symptom reduction was comparable. No differences were found between e-cigarette types, but Bayes factors indicate that these measures were insensitive. CONCLUSIONS During a 24-hour period in a hospital setting in the United States, nicotine exposure for dual users of e-cigarettes and cigarettes was similar when using cigarettes or variable-power tank devices only but was lower for those using cig-a-like or fixed-power devices only. Despite lower nicotine levels, all types of e-cigarette were effective in preventing withdrawal symptoms. E-cigarettes were rated less rewarding than cigarettes.",2020,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","['Thirty-six healthy dual users of e-cigarettes and cigarettes (n\xa0', 'Hospital research ward in San Francisco, California, USA']",[],"['withdrawal symptoms', '24-hour blood plasma nicotine concentrations', 'blood plasma nicotine and cotinine concentrations and 48-hour self-reported nicotine withdrawal symptoms and rewarding effects', 'withdrawal symptom reduction']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035168'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",36.0,0.0290211,"During a 24-hour period, e-cigarettes produced lower nicotine exposure than cigarettes for the majority of users, although 25% received more nicotine from e-cigarettes, which was predicted by more frequent e-cigarette use or greater dependence.","[{'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Center for Tobacco Control Research and Education, University of California, San Francisco, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14931'] 3368,1994013,Psychological aftermath of the King's Cross fire.,"The King's Cross fire occurred at the end of the evening rush hour, on 18 November 1987. King's Cross station is within the department's health district and we felt a responsibility to respond to the psychological aftermath. The unique features of our intervention were the degree of inter agency coordination, the use of a systematic outreach and screening programme, the collection of psychotherapy outcome measures and the development of an ongoing clinic. The work represents a sustained attempt to assess the nature and prevalence of post-traumatic reactions and the most medically and economically effective form of intervention. In this paper we describe the way our team responded to the high level of psychological distress that we found, we present some preliminary results, outline two therapeutic trials, and refer to the longterm consequences for the work of our department.",1991,King's Cross station is within the department's health district and we felt a responsibility to respond to the psychological aftermath.,[],[],[],[],[],[],,0.0157896,King's Cross station is within the department's health district and we felt a responsibility to respond to the psychological aftermath.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosser', 'Affiliation': 'Academic Department of Psychiatry, University College and Middlesex School of Medicine, London.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dewar', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3369,32034849,STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.,"OBJECTIVES To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally. DESIGN Open-label randomised controlled trial, with blinded outcome assessment. SETTING Community midwifery services in two National Health Service (NHS) trusts in the North West. SAMPLE A cohort of 2419 women receiving normal NHS postnatal care. METHODS Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses. MAIN OUTCOME MEASURE The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview. RESULTS Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost. CONCLUSIONS Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced. TWEETABLE ABSTRACT Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth.",2020,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","['Community midwifery services in two North West NHS Trusts', '678 women who screened positive (28.1', 'Midwives screened women for traumatic birth experience', '478 of 678 (70.5%) correctly randomised women and 9 randomised in error were followed up', '2419 women receiving usual NHS postnatal care']",['self-help with usual care (n=336) or usual care alone'],"['composite of diagnostic and sub-diagnostic PTSD', 'adverse effects', 'Diagnostic or sub-diagnostic PTSD rates', 'gold standard Clinician Administered PTSD Interview (CAPS-5']","[{'cui': 'C4075525', 'cui_str': 'Community midwifery service (qualifier value)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",2419.0,0.17233,"Diagnostic or sub-diagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (ITT analysis: relative risk (RR) 1.02, 95% confidence interval (CI) 0.68 to 1.53).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Slade', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'West', 'Affiliation': 'Department of Psychological Sciences, Institute of Health and Life Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': 'School of Community Health and Midwifery, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Spiby', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Charles', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Gwynedd, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garrett', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Flanagan', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Treadwell', 'Affiliation': 'Birth Trauma Association, Winchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hayden', 'Affiliation': ""Liverpool Women's Hospital Foundation Trust, Liverpool, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weeks', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16163'] 3370,2041002,Acceptability of binaural hearing aids: a cross-over study.,"Using screening questionnaires we were able to detect individuals aged 50-65 years with hearing disability in a general practice population. Those who had better ear hearing levels of 30 dB or worse were invited to take place in a cross-over study comparing the acceptability of a monaural or binaural hearing-aid fitting. Fifty-five per cent ultimately opted for a binaural fitting and had greater hearing disability and worse mean hearing levels than those who opted for a monaural fitting. They made their choice for acoustical reasons, particularly on the basis of improved localization ability.",1991,Fifty-five per cent ultimately opted for a binaural fitting and had greater hearing disability and worse mean hearing levels than those who opted for a monaural fitting.,"['Those who had better ear hearing levels of 30 dB or worse', 'individuals aged 50-65 years with hearing disability in a general practice population']",['binaural hearing aids'],['hearing disability and worse mean hearing levels'],"[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0848765', 'cui_str': 'Hearing disability'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0848765', 'cui_str': 'Hearing disability'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0146562,Fifty-five per cent ultimately opted for a binaural fitting and had greater hearing disability and worse mean hearing levels than those who opted for a monaural fitting.,"[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Stephens', 'Affiliation': 'Welsh Hearing Institute, University Hospital of Wales, Cardiff.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Callaghan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hogan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Meredith', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rayment', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3371,31785189,Components evaluation of a web-based personalized normative feedback intervention for alcohol use among college students: a pragmatic randomized controlled trial with a dismantling design.,"AIMS To evaluate the effects of the two main components of a personalized normative feedback (PNF) [normative feedback only (NFO); and consequences feedback only (CFO)] compared with the full intervention (PNF) in reducing alcohol use and consequences. DESIGN Three-arm pragmatic randomized controlled trial with dismantling design and 1-, 3- and 6-month follow-ups. SETTING Web-based among Brazilian college students. PARTICIPANTS College students (aged 18-30 years) who reported alcohol use in the last 3 months (n = 5476). INTERVENTIONS (1) Full PNF (a) drinking profile; (b) normative comparisons; (c) practical costs; (d) alcohol consequences; (e) strategies to decrease risks; (2) NFO components (a), (b) and (e); or (3) CFO components (c), (d) and (e). MEASUREMENTS The primary outcome was change in Alcohol Use Disorders Identification Test (AUDIT) score; secondary outcomes were the number of alcohol consequences, drinking frequency and typical/maximum number of drinks. We used mixed models with multiple imputation and a pattern-mixture model to account for attrition. Subgroup analyses considered participant motivation to know more about their drinking (less motivated versus motivated). FINDINGS Dismantled components reduced rather than increased AUDIT score compared to full PNF, with significant effects for NFO at 1 month [b = -0.23, 95% confidence interval (CI) = -0.46; -0.002] and for CFO at 3 months (b = -0.33, 95% CI = -0.62; -0.03). Compared with PNF, NFO reduced the number of alcohol consequences at 1 month (b = -0.16, 95% CI = -0.25; -0.06) and drinking frequency at 3 months (b = -0.42, 95% CI = -0.79; -0.05), but increased the number of typical drinks at 6 months (b = 0.38, 95% CI = 0.04; 0.72). CFO reduced drinking frequency at 3 months (b = -0.37, 95% CI = -0.73; -0.01). Attrition models confirmed all results, except for the NFO effect on typical drinks and drinking frequency. Subgroup analyses indicated superiority of dismantled components among the students less motivated in knowing more about their drinking. CONCLUSIONS There was no evidence that either the normative or the consequences components of a web-based personalized normative feedback intervention to reduce alcohol use and its consequences contributed to intervention effects. There was some evidence of adverse effects of personalized normative feedback, and these results were driven by 20% of participants who were less motivated in knowing more about their drinking.",2020,CFO reduced drinking frequency at 3 months (b=-0.37 95%CI:-0.73;-0.01).,"['college students', 'College students (18-30 years old) who reported alcohol use in the last three months (N=5,476', 'Brazilian college students']","['PNF, NFO', 'Personalised Normative Feedback (PNF) intervention', 'web-based personalised normative feedback intervention', 'full intervention (PNF', 'Personalised Normative Feedback (PNF) (Normative feedback only -NFO; and Consequences feedback only - CFO']","['NFO effect on typical drinks and drinking frequency', 'CFO reduced drinking frequency', 'number of alcohol consequences', 'adverse effects of PNF', 'drinking frequency', 'number of alcohol consequences, drinking frequency, and typical/maximum number of drinks', 'number of typical drinks']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.123842,CFO reduced drinking frequency at 3 months (b=-0.37 95%CI:-0.73;-0.01).,"[{'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Bedendo', 'Affiliation': 'Research Center on Health and Substance Use (NEPSIS), Department of Psychobiology, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'McCambridge', 'Affiliation': 'Department of Health Sciences, Faculty of Sciences, University of York, York, UK.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Gaume', 'Affiliation': 'Alcohol Treatment Centre, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Altay A L', 'Initials': 'AAL', 'LastName': 'Souza', 'Affiliation': 'Associação Fundo de Incentivo à Pesquisa (AFIP), São Paulo, Brazil.'}, {'ForeName': 'Maria Lucia O S', 'Initials': 'MLOS', 'LastName': 'Formigoni', 'Affiliation': 'Disciplina de Medicina e Sociologia do Abuso de Drogas - Departamento de Psicobiologia, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Noto', 'Affiliation': 'Research Center on Health and Substance Use (NEPSIS), Department of Psychobiology, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil.'}]","Addiction (Abingdon, England)",['10.1111/add.14923'] 3372,31764289,"Efficacy and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction-A Randomized, Double-Masked, Sham-Controlled Clinical Trial.","PURPOSE To study the efficacy and safety of intense pulsed light (IPL) in patients with meibomian gland dysfunction (MGD). METHODS This prospective randomized double-masked sham-controlled trial included 114 patients with MGD. Patients were randomized into the IPL or sham group. Either the IPL or sham procedure was performed on days 0, 15, and 45. Ocular Surface Disease Index (OSDI), visual analog scale, visual acuity, tear breakup time, meibum quality and expressibility, meibography grade, ocular surface staining, tear film lipid layer thickness, tear osmolarity, Schirmer test, tear interleukin-1 receptor agonist, and interleukin-6 levels were examined on days 0, 15, and 45 and at months 3 and 6. Subgroup analysis according to stage and the patient's compliance to conventional treatment were also analyzed. Any adverse events during the study were recorded. A multilevel mixed-effect linear regression model was used. P value less than 0.05 was considered statistically significant. RESULTS At 6 months, tear breakup time, meibum quality grades, expressibility grades, and OSDI were better in the IPL group (5.23 ± 2.91 vs. 3.11 ± 0.99 seconds, P < 0.001; 8.74 ± 4.74 vs. 13.19 ± 5.01, P < 0.001; 0.50 ± 0.67 vs. 1.12 ± 0.70, P < 0.001; 24.29 ± 16.92 vs. 32.71 ± 20.07, P < 0.05). OSDI, meibum quality, and expressibility in the IPL group began to improve at day 15 (P < 0.001), whereas the results in the sham group began to improve at day 45 (P < 0001). No adverse event occurred after IPL. CONCLUSIONS IPL is effective and safe for MGD treatment in all stages regardless of compliance.",2020,"No adverse event occurred after IPL. ","['Patients With Meibomian Gland Dysfunction', 'patients with meibomian gland dysfunction (MGD', '114 patients with MGD']","['intense pulsed light (IPL', 'IPL', 'Intense Pulsed Light']","['tear breakup time, meibum quality grades, expressibility grades, and OSDI', 'OSDI, meibum quality, and expressibility', 'efficacy and safety', 'Efficacy and Safety', 'adverse event', 'Ocular Surface Disease Index (OSDI), visual analog scale, visual acuity, tear breakup time, meibum quality and expressibility, meibography grade, ocular surface staining, tear film lipid layer thickness, tear osmolarity, Schirmer test, tear interleukin-1 receptor agonist, and interleukin-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",114.0,0.255735,"No adverse event occurred after IPL. ","[{'ForeName': 'Yonrawee', 'Initials': 'Y', 'LastName': 'Piyacomn', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Ngamjit', 'Initials': 'N', 'LastName': 'Kasetsuwan', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Usanee', 'Initials': 'U', 'LastName': 'Reinprayoon', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Vannarut', 'Initials': 'V', 'LastName': 'Satitpitakul', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Tesapirat', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Cornea,['10.1097/ICO.0000000000002204'] 3373,1941852,Treatment of basal cell carcinoma with intralesional interferon alpha-2b.,"We report a series of 11 basal cell carcinomas of various types treated with nine intra-lesional injections of 1.5 million units of interferon alpha-2b. The diagnosis was confirmed histologically in each case. After 3 months' follow-up six tumours had resolved both clinically and histologically. In three cases the tumour size was reduced. One tumour grew larger. Side effects were well tolerated except by one subject who was withdrawn. Those cases which responded have now been followed-up for between 12 and 26 months with no clinical or histological evidence of tumour recurrence. This is the longest period of follow-up so far reported for this novel treatment. The results are encouraging and, if maintained in future series, may indicate a useful role for interferon alpha in the management of this common cutaneous malignancy.",1991,Side effects were well tolerated except by one subject who was withdrawn.,['11 basal cell carcinomas of various types treated with nine intra-lesional injections of 1.5 million units of'],"['intralesional interferon alpha-2b', 'interferon alpha-2b']",[],"[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1306898', 'cui_str': 'mU'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]",[],,0.0283104,Side effects were well tolerated except by one subject who was withdrawn.,"[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Healsmith', 'Affiliation': 'Department of Dermatology, Leicester Royal Infirmary.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berth-Jones', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Graham-Brown', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3374,31876012,Long-term efficacy of meaning-centered group psychotherapy for cancer survivors: 2-Year follow-up results of a randomized controlled trial.,"OBJECTIVE Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention to improve personal meaning, psychological well-being, and depressive symptoms until 6 months after the intervention. In this study, the long-term effects of MCGP-CS (i.e., at 1- and 2-year follow-up) on meaning, psychological well-being and posttraumatic growth were assessed, in comparison to supportive group psychotherapy (SGP) and care as usual (CAU). METHODS Cancer survivors (n = 170) were randomized into MCGP-CS, SGP, or CAU. Assessments were scheduled at baseline, 1 week, 3 months, 6 months, 1 year, and 2 years postintervention. Outcome measures were the Personal Meaning Profile, Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory, and their subscales. Linear mixed models (LMM) were used and results were both reported on an intention-to-treat (ITT) basis, as well as for intervention completers only. RESULTS LMM and post hoc analyses with Bonferroni correction revealed that MCGP-CS participants reported more improvement on positive relations (subscale of SPWB) than CAU participants of 2-year postintervention (ITT analysis, Cohen's d = .82). Completers also reported more personal growth (subscale of SPWB) after MCGP-CS than after SGP 1-year postintervention (Cohen's d = .94). No long-term effects were found on the other outcome measures. CONCLUSIONS In the 2 years after MCGP-CS, the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded. However, MCGP-CS had a long-term positive effect on positive relations with others and on survivors' sense of personal growth. TRIAL REGISTRATION Netherlands Trial Register: NTR3571.",2020,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"['cancer survivors (MCGP-CS', 'cancer survivors', 'Cancer survivors (n=170']","['meaning-centered group psychotherapy', 'MCGP-CS', 'Meaning-centered group psychotherapy', 'MCGP-CS, SGP or CAU', 'supportive group psychotherapy (SGP) and care as usual (CAU']","['positive relations (subscale of SPWB', ""Personal Meaning Profile (PMP), Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory (PTGI), and their subscales"", 'personal meaning', 'personal growth (subscale of SPWB']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.154505,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'van der Spek', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5323'] 3375,31813542,Hypnosis Program Effectiveness in a 12-week Home Care Intervention To Manage Chronic Pain in Elderly Women: A Pilot Trial.,"PURPOSE As the prevalence of pain increases with age, taking too much medication can lead to negative side effects in elderly patients. While evidence in the literature has shown that clinical hypnosis is effective in an adult population, there are few studies in an aging population and efficacy has never been established in a home care setting. The goal of this study was to determine the effects of a hypnosis program delivered during home care interventions in elderly women during a 12-week period. METHODS This pilot trial took place from April 2016 to October 2017 at Limoges, France. Fifteen elderly women with chronic pain participated (81 (65-87) years old). All participants presented chronic pain for more than 6 months (inclusion criteria: average pain score >4/10). Participants took part in three 15-min hypnosis sessions separated by four to six weeks. Each hypnosis session was personalized and carried out with induction, pain perception alteration, and post-hypnotic suggestions. Pain perception and pain interference were evaluated with the Brief Pain Inventory questionnaire, and compared between before and after the 12-week hypnosis program. FINDINGS Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01). IMPLICATIONS Taken together, these findings show that a hypnosis intervention is feasible and effective to manage pain in an elderly population.",2020,"FINDINGS Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01). ","['Elderly Women', 'Fifteen elderly women with chronic pain participated (81 (65-87) years old', 'elderly women during a 12-week period', 'April 2016 to October 2017 at Limoges, France', 'elderly patients']","['Home Care Intervention', 'hypnosis intervention', 'hypnosis program']","['Pain perception and pain interference', 'Brief Pain Inventory questionnaire', 'pain interference with physical activity', 'current pain perception', 'chronic pain']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",15.0,0.0248422,"FINDINGS Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01). ","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France; PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France. Electronic address: maxime.billot@chu-poitiers.fr.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Jaglin', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Rainville', 'Affiliation': 'Department of Stomatology and the Montreal Research Center, Institute of Geriatrics, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Spine & Neuromodulation Functional Unit, Poitiers University Hospital, Poitiers, France; Prime Institute, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Langlois', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Noëlle', 'Initials': 'N', 'LastName': 'Cardinaud', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Tchalla', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.007'] 3376,31955968,Investigation of the Minimum Local Analgesic Concentration of Epidural Sufentanil Combined With Ropivacaine for Labor Analgesia.,"PURPOSE Worldwide, there are only few studies focusing on labor analgesia on the MLAC (minimum local analgesic concentration) or EC50 (median effective concentration) of sufentanil and ropivacaine. Therefore, we determine the MLAC or EC50 of sufentanil and ropivacaine for epidural analgesia by using an up-down sequential allocation and survey its adverse effect in a prospective blinded randomized trial. METHODS Sixty nulliparous full-term parturients who required labor analgesia were recruited and randomly divided into the sufentanil and ropivacaine groups. The formulation was 25 μg sufentanil combined with 0.1% ropivacaine (added 0.9% normal saline to 75 ml). According to the response of a previous parturient, the dosage of sufentanil was increased or decreased by 5 μg in the sufetanil group; meanwhile, we also administrated an initial concentration of 0.1% ropivacaine combined with 22.5 μg sufentanil (added 0.9% normal saline to 75 ml) in the ropivacaine group. The concentration of ropivacaine was increased or decreased by 0.01% following the response of the previous parturient. The Brownlee up-down sequential allocation was used to estimate the MLAC of epidural ropivacaine and its 95% confidence intervals in labor analgesia. FINDINGS There were no significant changes for the two groups, including for age, height weight, active stage, second stage of labor, and gestational weeks (P = 0.769, 0.900, 0.603, 0.441, 0.577, and 0.695, respectively). The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min. The EC50 dose of epidural ropivacaine combined with 0.3 μg/mL sufentanil was 0.09687%, and the 95% CI was 0.08944%~0.1043%. Five parturients had PONV, and the incidence rate was 16.7%; one parturient had pruritus, so the incidence rate was 3.3%. The EC50 dose of epidural sulfetanil combined with 0.1% ropivacaine was 18.76 μg with a 95% confidence interval of 13.5-24.48 μg. There were no significant differences in the active stage, second stage of labor, and maternal and fetal hemodynamic data between the two groups. Notably, the Apgar scores for 1 min and 5 min were 10 scores for almost all of these patients. There were no significant differences between the two groups for maternal and fetal side effects, which had very low incidence rates. IMPLICATIONS The MLAC of epidural sufentanil or ropivacaine could provide satisfactory and safe analgesia for parturients while having a low incidence rate of side effects.",2020,"The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min.","['Labor Analgesia', 'Sixty nulliparous full-term parturients who required labor analgesia']","['Epidural Sufentanil Combined With Ropivacaine', 'ropivacaine', 'sufentanil combined with 0.1% ropivacaine', 'ropivacaine combined with 22.5 μg sufentanil', 'mL sufentanil', 'sufentanil', 'sufentanil and ropivacaine', 'epidural ropivacaine']","['active stage, second stage of labor, and maternal and fetal hemodynamic data', 'Apgar scores', 'incidence rate', 'VAS scores', 'maternal and fetal side effects', 'effective analgesia', 'concentration of ropivacaine']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]",,0.245689,"The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'School of Nursing, Guangdong Pharmaceutical University, Guangzhou, 510310, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Wangping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital, Jiaxing University, Jiaxing 314000, China. Electronic address: zhang650679@163.com.""}, {'ForeName': 'Zeyong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China. Electronic address: yankylge@aliyun.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.011'] 3377,1900335,Transdermal glyceryl trinitrate to allow peripheral total parenteral nutrition: a double-blind placebo controlled feasibility study.,"Seventy-two consecutive patients requiring total parenteral nutrition (TPN) were randomized to two groups. Group A received daily a peripheral intravenous regimen which provided 10 g nitrogen and 1400 non-nitrogen kcal (5.9 MJ). Group B received daily a peripheral intravenous regimen which delivered 9.4 g nitrogen and 1900 non-nitrogen kcal (8.0 MJ). Each group was further randomized to receive a self-adhesive patch of transdermal glyceryl trinitrate (GTN) or an identical placebo. Infusion survival was the main end-point. For group A, the median time of infusion survival was 74 h (range: 58-100) in the control group compared with 108 h (range: 68-156) in the group that received transdermal GTN (P less than 0.001). For group B, the median infusion survival was 67 h (range: 46-92) in the control group compared with 103 h (range: 66-151) in the treatment group (P less than 0.001). TPN is feasible via peripheral veins and the incidence of infusion failure can be effectively reduced by transdermal GTN.",1991,TPN is feasible via peripheral veins and the incidence of infusion failure can be effectively reduced by transdermal GTN.,['Seventy-two consecutive patients requiring total parenteral nutrition (TPN'],"['placebo', 'transdermal GTN', 'TPN', 'self-adhesive patch of transdermal glyceryl trinitrate (GTN', 'Transdermal glyceryl trinitrate', 'peripheral intravenous regimen which delivered 9.4 g nitrogen and 1900 non-nitrogen kcal (8.0 MJ']","['Infusion survival', 'median infusion survival', 'median time of infusion survival']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0030548', 'cui_str': 'Parenteral Hyperalimentation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0969815,TPN is feasible via peripheral veins and the incidence of infusion failure can be effectively reduced by transdermal GTN.,"[{'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Khawaja', 'Affiliation': ""Department of Surgery, St Mary's Hospital, Portsmouth.""}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Weaver', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3378,31883703,"A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers.","PURPOSE Gantenerumab, a fully human anti-amyloid-β IgG1 monoclonal antibody that binds to aggregated forms of amyloid-β, is being investigated as a potential disease-modifying treatment for early (prodromal to mild) Alzheimer disease (AD). Our study compared the pain associated with 5- and 15-s subcutaneous injections of gantenerumab and evaluated the tolerability and pharmacokinetic properties of subcutaneous gantenerumab. METHODS This randomized, open-label, single-active-dose, placebo-controlled crossover study was conducted in 50 healthy volunteers aged 40-80 years with no history of clinically significant disorders, drug or alcohol abuse, familial history of early-onset AD, or prior gantenerumab exposure. Eligible participants were randomized to a sequence of one 300-mg SC gantenerumab injection into the abdomen and 2 SC placebo injections (1 into the abdomen and 1 into the thigh) during 5 or 15 s. All injections were administered at least 90 min apart. Participants were assessed for local pain by visual analog scale (VAS) and verbal rating scale; safety profiles were assessed by recording adverse events (AEs), and plasma pharmacokinetic properties were also evaluated. FINDINGS Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm). In both injection speed groups, the mean pain VAS score was comparable after subcutaneous gantenerumab and placebo injections into the abdomen. Pain was reported after needle insertion and immediately after dosing, subsiding within 5 min after the dose. The pain VAS score was numerically higher after SC placebo injection into the thigh versus abdomen (5-s injection group: mean [SD] VAS score, 26.68 [27.83] vs 19.20 [25.60] mm; 15-s injection group: mean [SD] VAS score, 14.16 [20.62] vs 9.48 [12.04] mm). No serious AEs were reported; no participants withdrew because of an AE. All AEs were of mild intensity, were transient, and had resolved without sequelae at follow-up. The most common AEs were injection site reactions; redness was the most frequently observed skin reactivity event after subcutaneous gantenerumab administration (5-s injection group: 36%; 15-s injection group: 32%). After subcutaneous administration, gantenerumab reached a peak plasma concentration at a median time of 119 h (approximately 5 days); plasma concentrations declined in a monoexponential manner. Comparable pharmacokinetic profiles were observed between the injection speed groups. IMPLICATIONS Subcutaneous gantenerumab injections at speeds of 5 and 15 s were well tolerated in healthy volunteers and could enable at-home administration by patients with AD or their caregivers. ClinicalTrials.gov identifier: NCT02882009.",2020,"FINDINGS Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm).","['Healthy Volunteers', '50 healthy volunteers aged 40-80 years with no history of clinically significant disorders, drug or alcohol abuse, familial history of early-onset AD, or prior gantenerumab exposure', 'Eligible participants', 'healthy volunteers']","['placebo', 'Gantenerumab', 'Subcutaneous gantenerumab injections', '300-mg SC gantenerumab injection into the abdomen and 2 SC placebo injections']","['pain VAS score', 'plasma concentrations', 'Pain', 'peak plasma concentration', 'mean pain VAS score', 'Pain, Tolerability, and Pharmacokinetics', 'adverse events (AEs), and plasma pharmacokinetic properties', 'local pain by visual analog scale (VAS) and verbal rating scale; safety profiles', 'tolerability and pharmacokinetic properties', 'injection site reactions; redness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2982066', 'cui_str': 'gantenerumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2982066', 'cui_str': 'gantenerumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]",50.0,0.237961,"FINDINGS Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm).","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Portron', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jordan', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Draper', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Muenzer', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRA Health Sciences, Lenexa, KS, USA.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'van Iersel', 'Affiliation': 'PRA Health Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Hofmann', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: carsten.hofmann@roche.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.015'] 3379,32023382,Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.,,2020,,['Type 1 Diabetes'],['Closed-Loop Control'],[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0350658,,"[{'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Zuñiga-Hernandez', 'Affiliation': 'Universidad Autónoma de Nuevo León, Monterrey, México.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Medrano-De Avila', 'Affiliation': 'Hospital Universitario Dr. José Eleuterio González, Monterrey, Mexico.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rodríguez-Gutiérrez', 'Affiliation': 'Plataforma Invest Knowledge and Evaluation Research Unit México, Monterrey, Mexico rodriguezgutierrez.rene@mayo.edu.'}]",The New England journal of medicine,['10.1056/NEJMc1915995'] 3380,30137473,Dual-Process Bereavement Group Intervention (DPBGI) for Widowed Older Adults.,"BACKGROUND AND OBJECTIVES To examine the primary and secondary outcomes of a theory-driven group bereavement intervention for widowed older adults through a cluster-randomized controlled trial. RESEARCH DESIGNS AND METHODS Twelve community centers providing health and social services for elderly people were randomly assigned to the experimental condition, the dual-process bereavement group intervention-Chinese (DPBGI-C) and to the control condition, the loss-oriented bereavement group intervention-Chinese (LOBGI-C). Both interventions comprised weekly, 2-hr sessions for 7 weeks followed by a 4-hr outing in the eighth week. Of 215 widowed older adults contacted and assessed, 125 eligible participants were interviewed three times-preintervention, postintervention, and at a 16-week follow-up-to assess complicated grief symptoms, anxiety, depression, loneliness, and social support. RESULTS Using intention-to-treat analysis, both interventions produced improvements in grief, depression, and social support, but effect sizes were larger with the DPBGI-C. The participants in the DPBGI-C condition also reported reduced anxiety, emotional loneliness, and social loneliness, whereas those in the LOBGI-C condition did not. There were interactions between intervention type and time with respect to grief, anxiety, emotional loneliness, and social loneliness. DISCUSSION AND IMPLICATIONS Although traditional LOBGI-C can help to reduce grief and depression in bereaved older adults, the DPBGI-C was found to be superior as it had a greater and more extensive impact on outcomes. This is the first study of the effectiveness of this evidence-based, theory-driven intervention for widowed Chinese older adults and has implications for theory building and practice.",2019,"The participants in the DPBGI-C condition also reported reduced anxiety, emotional loneliness, and social loneliness, whereas those in the LOBGI-C condition did not.","['215 widowed older adults contacted and assessed, 125 eligible participants', 'elderly people', 'widowed older adults', 'widowed Chinese older adults', 'Widowed Older Adults']","['theory-driven intervention', 'theory-driven group bereavement intervention', 'Dual-Process Bereavement Group Intervention (DPBGI', 'dual-process bereavement group intervention-Chinese (DPBGI-C) and to the control condition, the loss-oriented bereavement group intervention-Chinese (LOBGI-C']","['grief, depression, and social support', 'grief and depression', 'grief, anxiety, emotional loneliness, and social loneliness', 'reduced anxiety, emotional loneliness, and social loneliness', 'complicated grief symptoms, anxiety, depression, loneliness, and social support']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0206275', 'cui_str': 'Widowhood'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037438'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",125.0,0.0295561,"The participants in the DPBGI-C condition also reported reduced anxiety, emotional loneliness, and social loneliness, whereas those in the LOBGI-C condition did not.","[{'ForeName': 'Amy Y M', 'Initials': 'AYM', 'LastName': 'Chow', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Caserta', 'Affiliation': 'College of Nursing, University of Utah, Salt Lake City.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Lund', 'Affiliation': 'Department of Sociology, California State University San Bernardino.'}, {'ForeName': 'Margaret H P', 'Initials': 'MHP', 'LastName': 'Suen', 'Affiliation': 'Department of Medical Social Work, Caritas Medical Centre, Hong Kong.'}, {'ForeName': 'Daiming', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam.'}, {'ForeName': 'Iris K N', 'Initials': 'IKN', 'LastName': 'Chan', 'Affiliation': 'Jockey Club End-of-Life Community Care Project, Faculty of Social Sciences, The University of Hong Kong, Pokfulam.'}, {'ForeName': 'Kurtee S M', 'Initials': 'KSM', 'LastName': 'Chu', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam.'}]",The Gerontologist,['10.1093/geront/gny095'] 3381,32023381,Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.,,2020,,['Type 1 Diabetes'],['Closed-Loop Control'],[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0350658,,"[{'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Takita', 'Affiliation': 'Navitas Clinic, Tokyo, Japan takita-ygc@umin.net.'}]",The New England journal of medicine,['10.1056/NEJMc1915995'] 3382,1744867,A novel approach to anxiolytic premedication for day-case patients.,"The usefulness of 10 mg timolol orally as a non-sedative anxiolytic premedicant for day-case patients was examined in a double-blind placebo-controlled study. Patients were invited to take part by letter sent the week before gynaecological (n = 40) or oral (n = 60) surgery was scheduled. Indices of anxiety and alertness were obtained prior to administration of the tablet; quality of previous anaesthetic experience was also recorded. In those patients with no previous or unpleasant previous anaesthetic experience a significant reduction in anxiety amongst those given timolol was identified. Haemodynamic differences between the groups were not clinically significant, and return of psychomotor function was not delayed by timolol. Timolol effectively reduces situational anxiety, is non-sedative, and is advocated as a premedicant for anxious day-case patients and others in whom rapid return of psychomotor function is desirable.",1991,"Haemodynamic differences between the groups were not clinically significant, and return of psychomotor function was not delayed by timolol.","['Patients were invited to take part by letter sent the week before gynaecological (n = 40) or oral (n = 60) surgery was scheduled', 'day-case patients']","['placebo', 'Timolol', 'anxiolytic premedication', 'timolol']","['anxiety', 'situational anxiety', 'Haemodynamic differences', 'return of psychomotor function', 'Indices of anxiety and alertness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0040616', 'cui_str': 'Anti-Anxiety Drugs'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0262377', 'cui_str': 'Situational anxiety'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0187062,"Haemodynamic differences between the groups were not clinically significant, and return of psychomotor function was not delayed by timolol.","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Anaesthetics and Intensive Care, Royal Berkshire Hospital.'}]",Journal of the Royal Society of Medicine,[] 3383,32024400,Inferior stabilization of cementless compared with cemented dual-mobility cups in elderly osteoarthrosis patients: a randomized controlled radiostereometry study on 60 patients with 2 years' follow-up.,"Background and purpose - Elderly patients may benefit from a dislocation low-risk dual-mobility (DM) articulation in total hip arthroplasty, but the best cup fixation method is unknown. We compared cup migration for cemented and cementless DM cups using radiostereometry.Patients and methods - In a patient-blinded randomized trial, 60 patients (33 female) with osteoarthritis were allocated to cemented (n = 30) or cementless (n = 30) Avantage DM cup fixation. Criteria were age above 70 years, and T-score above -4. We investigated cup migration, periprosthetic bone mineral density (BMD), and patient-reported outcome measures (PROMs) until 24 months postoperative follow-up.Results - At 24 months mean proximal cup migration was 0.11 mm (95% CI 0.00-0.23) for cemented cups and 0.09 mm (CI -0.09 to 0.28) for cementless cups. However, cementless cups generally migrated more than cemented cups at 12 and 24 months. Cemented cups had no measurable migration from 3 months' follow-up, while cementless cups had not yet stabilized at 24 months in all rotations. Cementless cups showed statistically significantly more maximum total point motion (MTPM) at 12- and 24-month follow-up compared with cemented cups in patients with low systemic BMD (p = 0.01). Periprosthetic BMD changes did not statisticially significantly correlate to proximal migration in either cup fixation group (p > 0.05). PROMs improved similarly in both groups.Interpretation - Cemented cups were well fixed at 3 months. The cementless cups migrated more in patients with low BMD, showed an inconsistent pattern of migration, and migrated in different directions during the first and second year without tendency to stabilization. Cemented fixation of the Avantage DM cup seems safer in elderly patients.",2020,Cementless cups showed statistically significantly more maximum total point motion (MTPM) at 12- and 24-month follow-up compared with cemented cups in patients with low systemic BMD (p = 0.01).,"['elderly osteoarthrosis patients', ""60 patients with 2 years' follow-up"", '60 patients (33 female) with osteoarthritis were allocated to cemented (n = 30) or cementless (n = 30', 'elderly patients']","['dislocation low-risk dual-mobility (DM) articulation', 'Avantage DM cup fixation', 'cemented dual-mobility cups', 'Cemented fixation of the Avantage DM cup']","['proximal migration', 'maximum total point motion (MTPM', 'cup migration, periprosthetic bone mineral density (BMD', 'proximal cup migration', 'Periprosthetic BMD changes']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",60.0,0.154119,Cementless cups showed statistically significantly more maximum total point motion (MTPM) at 12- and 24-month follow-up compared with cemented cups in patients with low systemic BMD (p = 0.01).,"[{'ForeName': 'Steffan', 'Initials': 'S', 'LastName': 'Tabori-Jensen', 'Affiliation': 'University Clinic for Hand, Hip and Knee Surgery, Regional Hospital West Jutland, Holstebro;'}, {'ForeName': 'Sebastian Breddam', 'Initials': 'SB', 'LastName': 'Mosegaard', 'Affiliation': 'University Clinic for Hand, Hip and Knee Surgery, Regional Hospital West Jutland, Holstebro;'}, {'ForeName': 'Torben B', 'Initials': 'TB', 'LastName': 'Hansen', 'Affiliation': 'University Clinic for Hand, Hip and Knee Surgery, Regional Hospital West Jutland, Holstebro;'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Stilling', 'Affiliation': 'University Clinic for Hand, Hip and Knee Surgery, Regional Hospital West Jutland, Holstebro;'}]",Acta orthopaedica,['10.1080/17453674.2020.1720978'] 3384,31686628,"Letter to the Editor regarding 'Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial'.",,2020,,['patients with acute proximal DVT'],['pharmacomechanical catheter-directed thrombolysis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]",[],,0.0887038,,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Gwozdz', 'Affiliation': ""Academic Department of Vascular Surgery, School of Cardiovascular Medicine and Science, Guy's and St Thomas' Hospital, King's College London, London, UK.""}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Baekgaard', 'Affiliation': 'Vascular Clinic, Gentofte Hospital and Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Silver', 'Affiliation': 'OhioHealth Heart & Vascular, Columbus, OH, USA.'}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Labropoulos', 'Affiliation': 'Department of Surgery, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Black', 'Affiliation': ""Academic Department of Vascular Surgery, School of Cardiovascular Medicine and Science, Guy's and St Thomas' Hospital, King's College London, London, UK.""}]","Vascular medicine (London, England)",['10.1177/1358863X19882753'] 3385,31996709,Home-based cognitive training in pediatric patients with acquired brain injury: preliminary results on efficacy of a randomized clinical trial.,"Cognitive rehabilitation may compensate for cognitive deficits of children with acquired brain injury (ABI), capitalizing on the use-dependent plasticity of a developing brain. Remote computerized cognitive training (CCT) may be delivered to patients in ecological settings, ensuring rehabilitation continuity. This work evaluated cognitive and psychological adjustment outcomes of an 8-week multi-domain, home-based CCT (Lumosity Cognitive Training) in a sample of patients with ABI aged 11-16 years. Two groups of patients were engaged in five CCT sessions per week for eight weeks (40 sessions). According to a stepped-wedge research design, one group (Training-first Group) started the CCT immediately, whereas the other group (Waiting-first Group) started the CCT after a comparable time of waiting list. Changes after the training and after the waiting period were compared in the two groups. Both groups improved in visual-spatial working memory more after the training than after the waiting-list period. The Training-first group improved also in arithmetic calculation speed. Findings indicate that a multi-domain CCT can produce benefits in visual-spatial working memory, probably because, in accordance with previous research, computer games heavily tax visuo-spatial abilities. This suggests that the prolonged stimulation of the same cognitive ability may generate the greatest benefits in children with ABI.",2020,The Training-first group improved also in arithmetic calculation speed.,"['pediatric patients with acquired brain injury', 'children with ABI', 'children with acquired brain injury (ABI', 'patients with ABI aged 11-16 years']","['Remote computerized cognitive training (CCT', 'Cognitive rehabilitation', 'Home-based cognitive training', '8-week multi-domain, home-based CCT (Lumosity Cognitive Training']",['visual-spatial working memory'],"[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0178132,The Training-first group improved also in arithmetic calculation speed.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Corti', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. claudia.corti@lanostrafamiglia.it.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Urgesi', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Geraldina', 'Initials': 'G', 'LastName': 'Poggi', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Strazzer', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Borgatti', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bardoni', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}]",Scientific reports,['10.1038/s41598-020-57952-5'] 3386,31990328,Changes in physical activity of adolescent girls in the context of their perception of the Healthy Me programme.,"BACKGROUND An assumption was made that results of programme evaluation lead to better understanding for whom this intervention may work. The aim of the article is to compare the changes in physical activity of the intervention programme participants depending on subjective assessment of its impact. METHODS The data were obtained from 14- to15-year-old Polish girls (N = 1120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018. Schools were randomly assigned to one of two types of intervention or to a control (null) group. Satisfaction with the programme according to 21 criteria was measured retrospectively just after the intervention. Change in MVPA (moderate-to-vigorous physical activity) during the programme implementation was assessed in relation to satisfaction level, and adjusted for initial MVPA. RESULTS In total, the MVPA did not change significantly comparing pre- and post-intervention surveys (3.94 ± 1.94 vs. 3.87 ± 1.93)-P = 0.093. However, the perceived notable improvement of functioning in 10 out of 21 areas was related to the unquestionable increase in MVPA (P ≤ 0.001). With respect to the four impact areas, an interaction was demonstrated between an intervention group and an improvement in the domain-specific functioning. The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention. CONCLUSIONS Indicators related to the implementation process and the results obtained during the Healthy Me programme evaluation could represent a change in motivational and environmental factors that indirectly affects adolescent girl's physical activity.",2020,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention. ","['14- to15-year-old Polish girls (N\u2009=\u20091120) from 48 random selected secondary schools participating in the 1-year Healthy Me programme in the 2017/2018', 'adolescent girls']",[],"['MVPA', 'physical activity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032377', 'cui_str': 'Polishes'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0196041,"The beneficial impact of the programme on these areas was associated with the improvement of physical activity only in case of full and null intervention. ","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mazur', 'Affiliation': 'Department of Humanization in Medicine and Sexology, University of Zielona Gora, Collegium Medicum, Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dzielska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Kleszczewska', 'Affiliation': 'Foundation of the Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oblacińska', 'Affiliation': 'Department of Child and Adolescent Health, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fijałkowska', 'Affiliation': 'Department of Cardiology, Institute of Mother and Child, Warsaw, Poland.'}]",European journal of public health,['10.1093/eurpub/ckz242'] 3387,1625259,Acute urinary retention secondary to carcinoma of the prostate. Is initial channel TURP beneficial?,"Over a 2-year period patients presenting with acute urinary retention secondary to locally advanced prostate carcinoma (stage T3/T4) were randomized to one of two treatments. Ten patients underwent channel transurethral resection of prostate (TURP) and bilateral orchidectomy, 12 patients underwent bilateral orchidectomy alone. Treatment by channel TURP and bilateral orchidectomy was complicated by difficulties in voiding in four patients, one requiring a further TURP. Ten of the 12 patients were voiding well one month following bilateral orchidectomy alone. Only two patients in this group required TURP. In patients with acute urinary retention secondary to prostate carcinoma, in whom hormonal manipulation is thought appropriate due to bulk of local tumour or metastatic disease, channel TURP may confer extra morbidity and therefore be held in reserve for those patients unable to void after hormonal manipulation.",1992,"Treatment by channel TURP and bilateral orchidectomy was complicated by difficulties in voiding in four patients, one requiring a further TURP.","['Acute urinary retention secondary to carcinoma of the prostate', 'patients with acute urinary retention secondary to prostate carcinoma', 'patients presenting with acute urinary retention secondary to locally advanced prostate carcinoma (stage T3/T4']","['channel transurethral resection of prostate (TURP) and bilateral orchidectomy', 'bilateral orchidectomy alone', 'channel TURP and bilateral orchidectomy']",['TURP'],"[{'cui': 'C0341742', 'cui_str': 'Acute retention of urine (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600139', 'cui_str': 'Carcinoma of prostate (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0007347', 'cui_str': 'Male Castration'}]","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}]",12.0,0.0234181,"Treatment by channel TURP and bilateral orchidectomy was complicated by difficulties in voiding in four patients, one requiring a further TURP.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Thomas', 'Affiliation': ""Department of Urology, St Mary's Hospital, Portsmouth.""}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Balaji', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Coptcoat', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Abercrombie', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3388,1674963,Gastric emptying procedures in the self-poisoned patient: are we forcing gastric content beyond the pylorus?,"A prospective, randomized, single-blind study was carried out to determine whether gastric content is forced into the small bowel when gastric-emptying procedures are employed in self-poisoned patients. They were asked to swallow barium-impregnated polythene pellets, immediately prior to either gastric lavage or ipecacuanha-induced emesis. A second group of patients, who did not require treatment, were used as controls. Sixty patients were recruited to the study. The data show a significant difference in the number of residual pellets in the small bowel of the treated group (n = 40), when compared with the control group (P less than 0.0001). There was no statistical difference in the number of pellets in the small bowel when the treated groups were compared with each other. In addition, the inefficiency of gastric-emptying procedures is highlighted; 58.5% of the total number of pellets ingested were retained in the gastrointestinal tract of the ipecacuanha-treated group, while 51.8% of total pellets ingested were retained in the gastric lavage-treated group.",1991,There was no statistical difference in the number of pellets in the small bowel when the treated groups were compared with each other.,['Sixty patients were recruited to the study'],"['swallow barium-impregnated polythene pellets, immediately prior to either gastric lavage or ipecacuanha-induced emesis']","['number of pellets in the small bowel', 'number of residual pellets', 'Gastric emptying procedures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0004749', 'cui_str': 'Barium'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C1998480', 'cui_str': 'Pellet - unit of product usage (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0017134', 'cui_str': 'Irrigation, Gastric'}, {'cui': 'C0022046', 'cui_str': 'ipecacuanha'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1998480', 'cui_str': 'Pellet - unit of product usage (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",60.0,0.0171885,There was no statistical difference in the number of pellets in the small bowel when the treated groups were compared with each other.,"[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Saetta', 'Affiliation': 'Emergency Department, Leicester Royal Infirmary, Infirmary Close.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'March', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Gaunt', 'Affiliation': ''}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Quinton', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3389,1433121,Aerobic exercise in the adjunctive treatment of depression: a randomized controlled trial.,"Two clinical trials have been conducted in a sample of depressed patients to determine whether the addition of an aerobic exercise programme to their usual treatment improved outcome after 12 weeks. In the first trial, an aerobic exercise group had a superior outcome compared with a control group in terms of trait anxiety and a standard psychiatric interview. A second trial was then conducted to compare an aerobic exercise programme with low intensity exercise. Both groups showed improvement but there were no significant differences between the groups. In neither trial was there any correlation between the extent of change in the subjects' physical fitness due to aerobic exercise and the extent of the improvement of psychiatric scores.",1992,"In the first trial, an aerobic exercise group had a superior outcome compared with a control group in terms of trait anxiety and a standard psychiatric interview.",['depression'],"['aerobic exercise programme with low intensity exercise', 'aerobic exercise programme', 'aerobic exercise', 'Aerobic exercise']","['trait anxiety and a standard psychiatric interview', 'psychiatric scores']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.175849,"In the first trial, an aerobic exercise group had a superior outcome compared with a control group in terms of trait anxiety and a standard psychiatric interview.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Veale', 'Affiliation': 'Academic Department of Psychiatry, Royal Free Hospital School of Medicine, London.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Le Fevre', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pantelis', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Souza', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sargeant', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3390,31921328,"Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding prevalence, infant growth velocity and postpartum weight loss in overweight or obese women: protocol for a randomized controlled trial.","Background Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced. Obesity rates have been increasing worldwide. Overweight or obese women have lower rates of breastfeeding and face mechanical, psychological and biological difficulties. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women; but there is a lack of evidence on its effectiveness in overweight women. Our purpose is to evaluate a new approach to exclusive breastfeeding counselling based on Carl Rogers' Centred-Client Theory in overweight women, and to examine effects on breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss. Methods A two-arm simple randomized controlled trial will be conducted in overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia. The intervention is exclusive breastfeeding counselling based on Rogers' theory but adapted for overweight women; it will be performed during the last month of pregnancy, 24 h after delivery and during early infancy (1 and 3 months postpartum). The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels. Intention to treat analysis will be performed to estimate the effect of the new counselling approach compared to standard management on the prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss. Discussion We hypothesize that the intervention will result in an increase in the initiation and maintenance of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery. It is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women. Trial registration (UTN) U1111-1228-9913 February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered.",2020,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","['Overweight or obese women', 'Trial registration\n\n\n(UTN) U1111-1228-9913 February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered', 'overweight women', 'normal weight women', 'overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia', 'overweight or obese women']","['new approach for exclusive breastfeeding counselling', 'Breastfeeding counselling']","['breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss', 'prolactin and macronutrient levels in breast milk and serum prolactin levels', 'breastfeeding prevalence, infant growth velocity and postpartum weight loss', 'exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4\u2009months after delivery', 'prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0951031,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Aldana-Parra', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Gilma', 'Initials': 'G', 'LastName': 'Olaya', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': '2UCL Great Ormond Street Institute of Child Health, London, UK.'}]",International breastfeeding journal,['10.1186/s13006-019-0249-2'] 3391,1671603,Residual gastric content after gastric lavage and ipecacuanha-induced emesis in self-poisoned patients: an endoscopic study.,"Flexible endoscopy was used to assess the intragastric residue after either ipecacuanha-induced emesis or gastric lavage in 30 self-poisoned patients. Of the 13 patients treated by induced-emesis, five (38.5%) had residual solid in the stomach; 17 patients were treated by gastric washout, and 15 (88.2%) of these had residual intragastric solid. The study provides direct evidence that the gastric decontaminating procedures employed, and especially gastric lavage, do not remove stomach contents completely.",1991,"Of the 13 patients treated by induced-emesis, five (38.5%) had residual solid in the stomach; 17 patients were treated by gastric washout, and 15 (88.2%) of these had residual intragastric solid.",['self-poisoned patients'],"['ipecacuanha-induced emesis or gastric lavage', 'Flexible endoscopy', 'ipecacuanha-induced emesis']",['Residual gastric content'],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032344', 'cui_str': 'poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022046', 'cui_str': 'ipecacuanha'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0017134', 'cui_str': 'Irrigation, Gastric'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0038352', 'cui_str': 'Stomach Contents'}]",17.0,0.0123706,"Of the 13 patients treated by induced-emesis, five (38.5%) had residual solid in the stomach; 17 patients were treated by gastric washout, and 15 (88.2%) of these had residual intragastric solid.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Saetta', 'Affiliation': 'Accident & Emergency Department, Leicester Royal Infirmary.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Quinton', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3392,1548650,Is undergraduate otoscopy teaching adequate?--An audit of clinical teaching.,"Otoscopy is an important skill for the general practitioner, yet skill in the technique is rarely assessed formally at undergraduate level. This study aimed to assess the effect of teaching on the acquisition of otoscopic skill. Thirty-five medical students were assessed prospectively during their ENT attachments. Seventeen students were randomized to the standard course and 18 attended an additional seminar on otoscopy. Students' confidence was assessed for various aspects of otoscopy using a visual analogue scale, and clinical skill was assessed in examining four patients. Assessments took place at the beginning and end of the course. Students gained in their confidence and skill for all parameters, although the clinical ability to distinguish normal from abnormal tympanic membranes changed little from baseline levels. Extra teaching produced better gains in confidence (P less than 0.05) and skill (P less than 0.01) in identifying specific features of the tympanic membrane and eliminated errors of the 'false negative' variety. A minimal investment in teaching effort produces appreciable gains in students' otoscopic skills. This has implication for the planning of undergraduate ENT courses and vocational training for general practice.",1992,Extra teaching produced better gains in confidence (P less than 0.05) and skill (P less than 0.01) in identifying specific features of the tympanic membrane and eliminated errors of the 'false negative' variety.,"['Seventeen students', 'Thirty-five medical students']",['standard course and 18 attended an additional seminar on otoscopy'],"['visual analogue scale, and clinical skill']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0847244', 'cui_str': 'Otoscopy'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skill'}]",35.0,0.0419871,Extra teaching produced better gains in confidence (P less than 0.05) and skill (P less than 0.01) in identifying specific features of the tympanic membrane and eliminated errors of the 'false negative' variety.,"[{'ForeName': 'E W', 'Initials': 'EW', 'LastName': 'Fisher', 'Affiliation': 'Royal National Throat, Nose and Ear Hospital, London.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Pfleiderer', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3393,32022990,Tacrolimus- versus sirolimus-based immunosuppression after simultaneous pancreas and kidney transplantation: 5-year results of a randomized trial.,"Tacrolimus, the cornerstone immunosuppression after simultaneous pancreas and -kidney (SPK) transplantation, may exert nephrotoxic and diabetogenic effects. We therefore prospectively compared in an open-label, randomized, monocentric, 5-year follow-up study, a tacrolimus- and a sirolimus-based immunosuppressive regimen. Randomization using the block method allowing a blind allocation was done at the time of surgery. All patients received anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil, and steroids. At month 3, tacrolimus was continued or replaced by sirolimus. The primary endpoint was kidney and pancreas graft survival at 1 and 5 years. Fifty patients were included in the final analysis in each group. At 1 year, differences for kidney and pancreas graft survival between sirolimus and tacrolimus were 0% (90% confidence interval -4.61% to 4.61%) and 6% (90% confidence interval -6.32% to 18.32%), respectively. There was no difference in renal and pancreas graft survival at 5 years. Thirty-four patients (68%) in the sirolimus group vs three (6%) in the tacrolimus group needed definitive withdrawal of the study drug. Despite noninferiority of sirolimus compared to tacrolimus for kidney and pancreas graft survival, the high rate of sirolimus discontinuation does not favor its use as cornerstone therapy after SPK transplantation (NCT00693446).",2020,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","['Fifty patients were included in final analysis in each group', 'after simultaneous pancreas and kidney transplantation']","['anti-thymocyte globulin and maintenance therapy with tacrolimus, mycophenolate mofetil and steroids', 'sirolimus and tacrolimus', 'Tacrolimus- versus Sirolimus-based immunosuppression', 'sirolimus-based immunosuppressive regimen', 'sirolimus', 'Tacrolimus', 'tacrolimus']","['kidney and pancreas graft survival', 'renal and pancreas graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030275', 'cui_str': 'Grafting, Pancreas'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",50.0,0.0453456,"At one year, difference for kidney and pancreas graft survival between sirolimus and tacrolimus were 0 % (CI 90 % [-4.61 %, 4.61 %]) and 6 % (CI 90 % [-6.32 %, 18.32 %]) respectively.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cantarovich', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Kervella', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Karam', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Dantal', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garandeau', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Houzet', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branchereau', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Delbos', 'Affiliation': ""Laboratoire d'Histocompatibilité, Etablissement Français du Sang, EFS, Pays de la Loire, Nantes, France.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Guillot-Gueguen', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Renaudin', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Soulillou', 'Affiliation': 'CHU Nantes, Université de Nantes, Inserm, Centre de Recherche en Transplantation et Immunologie, UMR 1064, ITUN, Nantes, France.'}, {'ForeName': 'Maryvonne', 'Initials': 'M', 'LastName': 'Hourmant', 'Affiliation': 'CHU Nantes, Université de Nantes, Institut de Transplantation, Urologie, Néphrologie, Nantes, France.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15809'] 3394,32022904,Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial.,"BACKGROUND Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation fluid has been reported to reduce the risk of worsening of AKI. Restrictive fluid therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-the REVERSE-AKI trial that compares a restrictive fluid therapy regimen to standard therapy in critically ill patients with AKI. METHODS REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive fluid treatment regimen vs standard management. In the restrictive fluid therapy regimen, the daily fluid balance target is neutral or negative. The primary outcome is the cumulative fluid balance assessed after 72 hours from randomization. Secondary outcomes include safety, feasibility, duration, and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). CONCLUSIONS This is the first multinational trial investigating the feasibility and safety of a restrictive fluid therapy regimen in critically ill patients with AKI. TRIAL REGISTRATION clinical.trials.gov NCT03251131.",2020,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). ","['Acute Kidney Injury', '100 critically ill patients with AKI to a restrictive fluid treatment regimen versus standard management', 'septic shock patients', '7 ICUs in 5 countries', 'critically ill patients with AKI']",['restrictive fluid therapy regimen'],"['safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence', 'cumulative fluid balance']","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}]",100.0,0.24103,"Secondary outcomes include safety, feasibility, duration and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). ","[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Selander', 'Affiliation': 'Science Service Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Elettra', 'Initials': 'E', 'LastName': 'Poli', 'Affiliation': 'Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hoste', 'Affiliation': 'Intensive Care Unit, Ghent University Hospital, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': 'Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Australian National University Medical School, Canberra, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Prowle', 'Affiliation': 'Critical Care and Preoperative Medicine Research Group, Centre for Translational Medicine and Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13557'] 3395,1548648,Comparison of controlled-release ketoprofen and diclofenac in the control of post-surgical dental pain.,"Preoperative treatment with controlled-release ketoprofen or diclofenac was compared in 56 out-patients, for control of postoperative dental pain, following unilateral or bilateral surgical removal of lower third molars. Six patients were excluded due to non-compliance, leaving 50 evaluable patients. Patients were assessed by the dental surgeon, on the day of the operation and one week later, prior to removal of sutures. Additionally, patients completed a daily diary during the postoperative week. Following surgery, scores for graded dental pain, consumption of paracetamol, incidence of dental bleeding, dysphagia, sleep disturbance and trismus were similar for the two treatment groups. However, median pain scores were consistently elevated in the diclofenac group over those seen with the ketoprofen group. The four adverse events reported were all minor and posed no problem to patient management.",1992,"However, median pain scores were consistently elevated in the diclofenac group over those seen with the ketoprofen group.","['post-surgical dental pain', '56 out-patients, for control of postoperative dental pain, following unilateral or bilateral surgical removal of lower third molars', 'Six patients were excluded due to non-compliance, leaving 50 evaluable patients']","['ketoprofen and diclofenac', 'ketoprofen', 'ketoprofen or diclofenac', 'diclofenac']","['graded dental pain, consumption of paracetamol, incidence of dental bleeding, dysphagia, sleep disturbance and trismus', 'median pain scores']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",6.0,0.0174974,"However, median pain scores were consistently elevated in the diclofenac group over those seen with the ketoprofen group.","[{'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Tai', 'Affiliation': 'Department of Anaesthesia, Russells Hall Hospital, Dudley, West Midlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3396,32019736,Comparison of efficacy of packed red blood cell transfusion based on its hemoglobin content versus the standard transfusion practice in thalassemia major patients (HEMOCON study).,"The hemoglobin (Hb) content of packed red blood cell (PRBC) units is heterogenous. The efficacy of a transfusion episode can be assessed if the Hb content of the PRBC is known and the patient's post-transfusion Hb increment is also determined. This prospective study compared the efficacy of PRBC transfusion based on its Hb content versus the standard transfusion practice. A total of 160 thalassemia major patients were enrolled and randomly divided into two equal groups: Group I (n = 80) - they received ABO/RhD identical PRBCs after determining its Hb content (≥50 g); and Group II (n = 80) - they received randomly selected ABO/RhD identical PRBCs. Hb estimation and a direct antiglobulin test were performed on the post-transfusion sample (1 h). The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g). The mean Hb increment was also significantly higher in group I patients (p = 0.04). In both the groups, there was a significant negative correlation between Hb increment and weight, age, body surface area and blood volume (p < 0.05). There was a significant positive correlation between Hb increment and Hb dose adjusted for body surface area as well as blood volume (p < 0.05). PRBC transfusion was more efficacious in patients who were transfused with PRBCs having a Hb content ≥50 g as compared to those who received randomly selected PRBCs.",2020,The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g).,"['thalassemia major patients (HEMOCON study', 'A total of 160 thalassemia major patients']","['packed red blood cell transfusion', 'ABO/RhD identical PRBCs after determining its Hb content (≥50 g); and Group II (n = 80) - they received randomly selected ABO/RhD identical PRBCs']","['hemoglobin (Hb) content of packed red blood cell (PRBC) units', 'weight, age, body surface area and blood volume', 'mean Hb increment', 'mean Hb content of the PRBC units', 'blood volume']","[{'cui': 'C0002875', 'cui_str': 'Thalassemia Major'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0199962', 'cui_str': 'Transfusion of packed red blood cells (procedure)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.013975,The mean Hb content of the PRBC units was significantly higher (p = 0.000) in group I (67.86 ± 8.07 g; range: 50.80-92.13 g) than group II (60.92 ± 8.29 g; range: 40.86-86.76 g).,"[{'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Raja', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. Electronic address: ashishjain16@gmail.com.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Marwaha', 'Affiliation': 'Department of Transfusion Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Trehan', 'Affiliation': 'Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis,['10.1016/j.transci.2020.102736'] 3397,32019696,"""Very humble"" vs. ""Not humble"": What do ratings of fictitious physician profiles with humility descriptors reveal about potential patient preferences and behaviors?","OBJECTIVES The current study examined the impact of physician humility on future medical interactions and physician-related outcomes (e.g., patient patronage, loyalty) using a non-patient, community sample. METHODS Participants (N = 417) were recruited online through Amazon Mechanical Turk (mTurk) and paid a nominal fee for their participation. They reviewed randomly assigned fictitious physician profiles that differed in humility (high, low), general effectiveness (high, low), physician gender (male, female), and specialty (family practice, orthopedic surgery). Then they reported their likelihood to trust, adhere to recommendations, and be satisfied with the physician. They also conveyed how likely they would select and recommend this physician to others, and how much out-of-pocket money they would be willing to spend to see the physician. RESULTS Humble physicians were rated higher than their non-humble counterparts on all five outcomes. For physicians who were generally ineffective, the physicians low in humility scored lower on intended adherence, trust, and anticipated satisfaction than the physicians high in humility. Additionally, for physicians specializing in family practice, physicians low in humility scored lower on anticipated satisfaction and out-of-pocket expenditure than the physicians high in humility. CONCLUSIONS Findings from this study highlight how physician humility can affect the process of care even before it begins. PRACTICE IMPLICATIONS The study emphasizes the need for deliberate pursuit of humility to improve outcomes for patients and physicians.",2020,"For physicians who were generally ineffective, the physicians low in humility scored lower on intended adherence, trust, and anticipated satisfaction than the physicians high in humility.","['patients and physicians', 'Participants (N = 417) were recruited']",['online through Amazon Mechanical Turk (mTurk) and paid a nominal fee for their participation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}]",[],417.0,0.0201008,"For physicians who were generally ineffective, the physicians low in humility scored lower on intended adherence, trust, and anticipated satisfaction than the physicians high in humility.","[{'ForeName': 'Ho Phi', 'Initials': 'HP', 'LastName': 'Huynh', 'Affiliation': 'Department of Science and Mathematics, Texas A&M University, San Antonio, USA. Electronic address: hhuynh@tamusa.edu.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Arthur', 'Affiliation': 'Department of Science and Mathematics, Texas A&M University, San Antonio, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Gamboa', 'Affiliation': 'Department of Science and Mathematics, Texas A&M University, San Antonio, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Escamilla', 'Affiliation': 'Department of Science and Mathematics, Texas A&M University, San Antonio, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.021'] 3398,31961419,Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial.,"Importance For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function. Objective To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes. Design, Setting, and Participants The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018. Interventions There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed. Main Outcomes and Measures The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality. Results Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach. Conclusions and Relevance Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings. Trial Registration ISRCTN Identifier: ISRCTN45877994.",2020,Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10).,"['44 patients randomized to the early surgery group who underwent', 'patients with painful chronic pancreatitis', '30 Dutch hospitals participating in the Dutch Pancreatitis Study Group', 'Patients With Chronic Pancreatitis', 'From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included', 'patients with chronic pancreatitis, early surgery', '88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial']","['endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed', 'pancreatic drainage surgery', 'Early Surgery vs Endoscopy-First Approach']","['Pain', 'pain severity', 'pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality', 'mortality', 'pain, measured on the Izbicki pain score', 'Complete or partial pain relief', 'Izbicki pain score', 'Treatment complications', 'pain scores', 'hospital admissions, pancreatic function, and quality of life', 'total number of interventions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0447557', 'cui_str': ""Wirsung's Duct""}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",88.0,0.178325,Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10).,"[{'ForeName': 'Yama', 'Initials': 'Y', 'LastName': 'Issa', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marinus A', 'Initials': 'MA', 'LastName': 'Kempeneers', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marco J', 'Initials': 'MJ', 'LastName': 'Bruno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology and Hepatology; Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan-Werner', 'Initials': 'JW', 'LastName': 'Poley', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Usama', 'Initials': 'U', 'LastName': 'Ahmed Ali', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Bollen', 'Affiliation': 'Department of Radiology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees H', 'Initials': 'CH', 'LastName': 'Dejong', 'Affiliation': 'Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Duijvendijk', 'Affiliation': 'Department of Surgery, Gelre Hospital, Apeldoorn, the Netherlands.'}, {'ForeName': 'Hendrik M', 'Initials': 'HM', 'LastName': 'van Dullemen', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Casper H', 'Initials': 'CH', 'LastName': 'van Eijck', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Hadithi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'Haveman', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Keulemans', 'Affiliation': 'Department of Gastroenterology and Hepatology, Zuyderland Hospital, Sittard/Heerlen, the Netherlands.'}, {'ForeName': 'Vincent B', 'Initials': 'VB', 'LastName': 'Nieuwenhuijs', 'Affiliation': 'Department of Surgery, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Poen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Rauws', 'Affiliation': 'Department of Gastroenterology and Hepatology; Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriaan C', 'Initials': 'AC', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology and Hepatology, Canisius-Wilhemina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Thijs', 'Affiliation': 'Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Timmer', 'Affiliation': 'Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Witteman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeanin E', 'Initials': 'JE', 'LastName': 'van Hooft', 'Affiliation': 'Department of Gastroenterology and Hepatology; Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Marcel G', 'Initials': 'MG', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam Public Health, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.20967'] 3399,31994254,Nicotine delivery and users' reactions to Juul compared with cigarettes and other e-cigarette products.,"AIMS To assess the pharmacokinetic (PK) profile of, and users' reactions to, Juul (59 mg nicotine/ml) as an indication of its therapeutic and dependence potential. DESIGN Cross-over, within-subjects study in which participants attended after overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5 minutes. The Juul product used was the version available in the United States that has more nicotine in the e-liquid than the one available in the European Union. SETTING Laboratory setting in the United Kingdom. PARTICIPANTS Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products. MEASUREMENTS At each session, number of puffs taken was counted during the 5-minute product use period and blood samples were taken at baseline and at 2, 4, 6, 8, 10 and 30 minutes after starting smoking/vaping and analysed for nicotine. Participants also monitored their urges to smoke and rated the products on a range of characteristics. FINDINGS Juul's PK profile was close to the PK profile of cigarettes [maximum concentration (C max ) = 20.4 versus 19.2 ng/ml; time to maximum concentration (T max ) = 4 versus 6 minutes; area under the curve (AUC): 307.9 versus 312.6, respectively]. Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084). Compared with other e-cigarette products, it also provided faster reduction of urges to smoke and obtained more favourable subjective ratings. CONCLUSION Juul's PK profile and user ratings suggest that it could be more effective than other EC products in helping smokers to quit smoking, but it may also have a higher potential to generate regular use in non-smokers.",2020,"Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","['Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products']","['Nicotine', 'Juul (59\xa0mg nicotine/ml', 'overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5\xa0minutes']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],,0.051452,"Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pittaccio', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14936'] 3400,31942042,Exploring the receptor origin of vibration-induced reflexes.,"STUDY DESIGN An experimental design. OBJECTIVES The aim of this study was to determine the latencies of vibration-induced reflexes in individuals with and without spinal cord injury (SCI), and to compare these latencies to identify differences in reflex circuitries. SETTING A tertiary rehabilitation center in Istanbul. METHODS Seventeen individuals with chronic SCI (SCI group) and 23 participants without SCI (Control group) were included in this study. Latency of tonic vibration reflex (TVR) and whole-body vibration-induced muscular reflex (WBV-IMR) of the left soleus muscle was tested for estimating the reflex origins. The local tendon vibration was applied at six different vibration frequencies (50, 85, 140, 185, 235, and 265 Hz), each lasting for 15 s with 3-s rest intervals. The WBV was applied at six different vibration frequencies (35, 37, 39, 41, 43, and 45 Hz), each lasting for 15 s with 3-s rest intervals. RESULTS Mean (SD) TVR latency was 39.7 (5.3) ms in the SCI group and 35.9 (2.7) ms in the Control group with a mean (95% CI) difference of -3.8 (-6.7 to -0.9) ms. Mean (SD) WBV-IMR latency was 45.8 (7.4) ms in the SCI group and 43.3 (3.0) ms in the Control group with a mean (95% CI) difference of -2.5 (-6.5 to 1.4) ms. There were significant differences between TVR latency and WBV-IMR latency in both the groups (mean (95% CI) difference; -6.2 (-9.3 to -3.0) ms, p = 0.0001 for the SCI group and -7.4 (-9.3 to -5.6) ms, p = 0.011 for Control group). CONCLUSIONS The results suggest that the receptor of origin of TVR and WBV-IMR may be different.",2020,"There were significant differences between TVR latency and WBV-IMR latency in both the groups (mean (95% CI) difference; -6.2 (-9.3 to -3.0) ms, p = 0.0001 for the SCI group and -7.4 (-9.3 to -5.6) ms, p = 0.011 for Control group). ","['Seventeen individuals with chronic SCI (SCI group) and 23 participants without SCI (Control group', 'individuals with and without spinal cord injury (SCI', 'A tertiary rehabilitation center in Istanbul']",[],"['TVR latency and WBV-IMR latency', 'Latency of tonic vibration reflex (TVR) and whole-body vibration-induced muscular reflex (WBV-IMR', 'latencies of vibration-induced reflexes', 'Mean (SD) TVR latency', 'Mean (SD) WBV-IMR latency']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}]",[],"[{'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0034943', 'cui_str': 'Reflex, Tendon'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",17.0,0.029,"There were significant differences between TVR latency and WBV-IMR latency in both the groups (mean (95% CI) difference; -6.2 (-9.3 to -3.0) ms, p = 0.0001 for the SCI group and -7.4 (-9.3 to -5.6) ms, p = 0.011 for Control group). ","[{'ForeName': 'Mustafa A', 'Initials': 'MA', 'LastName': 'Yildirim', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Betilay', 'Initials': 'B', 'LastName': 'Topkara', 'Affiliation': 'Physiology Department, Koç University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Paker', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Soy', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Coskun', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Ones', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Bardak', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Kesiktas', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa G', 'Initials': 'MG', 'LastName': 'Ozyurt', 'Affiliation': 'Physiology Department, Koç University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Celik', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Onder', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Kılıc', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Habib C', 'Initials': 'HC', 'LastName': 'Kucuk', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Karacan', 'Affiliation': 'İstanbul Physical Medicine Rehabilitation Training and Research Hospital, Istanbul, Turkey. ilhankaracan@hotmail.com.'}, {'ForeName': 'Kemal S', 'Initials': 'KS', 'LastName': 'Türker', 'Affiliation': 'Physiology Department, Koç University School of Medicine, Istanbul, Turkey.'}]",Spinal cord,['10.1038/s41393-020-0419-5'] 3401,31000010,Complete Revascularization Versus Culprit Lesion Only in Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: A DANAMI-3-PRIMULTI Cardiac Magnetic Resonance Substudy.,"OBJECTIVES The aim of this study was to evaluate the effect of fractional flow reserve (FFR)-guided revascularization compared with culprit-only percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) on infarct size, left ventricular (LV), function, LV remodeling, and the presence of nonculprit infarctions. BACKGROUND Patients with STEMI with multivessel disease might have improved clinical outcomes after complete revascularization compared with PCI of the infarct-related artery only, but the impact on infarct size, LV function, and remodeling as well as the risk for periprocedural infarction are unknown. METHODS In this substudy of the DANAMI-3 (Third Danish Trial in Acute Myocardial Infarction)-PRIMULTI (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization) randomized trial, patients with STEMI with multivessel disease were randomized to receive either complete FFR-guided revascularization or PCI of the culprit vessel only. The patients underwent cardiac magnetic resonance imaging during index admission and at 3-month follow-up. RESULTS A total of 280 patients (136 patients with infarct-related and 144 with complete FFR-guided revascularization) were included. There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63). New nonculprit infarction occurring after the nonculprit intervention was numerically more frequent among patients treated with complete revascularization (6 [4.5%] vs. 1 [0.8%]; p = 0.12). CONCLUSIONS Complete FFR-guided revascularization in patients with STEMI and multivessel disease did not affect final infarct size, LV function, or remodeling compared with culprit-only PCI.",2019,"There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63).","['patients with STEMI with multivessel disease', 'patients with ST-segment elevation myocardial\xa0infarction (STEMI', 'Patients With ST-Elevation Myocardial Infarction and Multivessel Disease', '280 patients (136 patients with infarct-related and 144 with complete FFR-guided revascularization', 'Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease', 'Patients with STEMI with multivessel disease']","['complete FFR-guided revascularization or PCI of the culprit vessel only', 'fractional flow reserve (FFR)-guided revascularization compared with culprit-only percutaneous coronary intervention (PCI', 'cardiac magnetic resonance imaging']","['final infarct size', 'LV end-systolic volume remodeling', 'LV ejection fraction', 'myocardial salvage index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",280.0,0.118493,"There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63).","[{'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Kyhl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. Electronic address: kasperkyhl@gmail.com.'}, {'ForeName': 'Kiril Aleksov', 'Initials': 'KA', 'LastName': 'Ahtarovski', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nepper-Christensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Ekström', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Adam Ali', 'Initials': 'AA', 'LastName': 'Ghotbi', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Schoos', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Göransson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Litten', 'Initials': 'L', 'LastName': 'Bertelsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Saunamäki', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of Medicine, Nykoebing F Hospital, Nykoebing F and University of Southern Denmark, Odense, Denmark; University Clinic of Hamburg-Eppendorf, The Heart Centre, Hamburg, Germany.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Vejlstrup', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Zealand University, Roskilde, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Cardiology, University of Lund, Lund, Sweden.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.01.248'] 3402,31820321,"Healthy Start-Départ Santé: A pilot study of a multilevel intervention to increase physical activity, fundamental movement skills and healthy eating in rural childcare centres.","OBJECTIVES In order to improve healthy behaviours among rural children in their early years, a physical activity and healthy eating intervention (Healthy Start-Départ Santé) was implemented in rural childcare centres throughout Saskatchewan. The objective of the current study was to evaluate the impact of a multimodal physical activity and healthy eating intervention on educators' provision of opportunities for children to improve their physical activity levels, fundamental movement skills and healthy eating behaviours. SETTINGS Six childcare centres (three Francophone and three Anglophone) located in five different rural and semi-rural communities in Saskatchewan participated in this intervention. PARTICIPANTS A total of 69 children with a mean age of 4 years 9 months, and 19 female early childhood educators. INTERVENTION Guided by an ecological framework, we implemented a population health controlled intervention, using a wait list control design (48 weeks delayed intervention), and evaluated its impact in rural childcare centres. Mixed methods were employed to determine the effectiveness of the intervention. OUTCOMES Overall, educators felt that the intervention supported the provision of physical activity and healthy eating opportunities for children. Increases in children's physical activity levels were reported following the intervention. CONCLUSION The lessons learned in this study can be used to improve the Healthy Start-Départ Santé intervention so that its implementation can be effectively expanded to childcare centres within and outside Saskatchewan, in turn, supporting the healthy development of early years (0-5) children in the province and beyond.",2016,"The lessons learned in this study can be used to improve the Healthy Start-Départ Santé intervention so that its implementation can be effectively expanded to childcare centres within and outside Saskatchewan, in turn, supporting the healthy development of early years (0-5) children in the province and beyond.","['rural children in their early years, a physical activity and healthy eating intervention (Healthy Start-Départ Santé) was implemented in rural childcare centres throughout Saskatchewan', 'rural childcare centres', 'A total of 69 children with a mean age of 4 years 9 months, and 19 female early childhood educators', 'Six childcare centres (three Francophone and three Anglophone) located in five different rural and semi-rural communities in Saskatchewan participated in this intervention', 'Healthy Start-Départ Santé']","['multimodal physical activity and healthy eating intervention', 'multilevel intervention']","['physical activity, fundamental movement skills and healthy eating', ""children's physical activity levels"", 'healthy behaviours']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036234', 'cui_str': 'Saskatchewan'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",69.0,0.0395399,"The lessons learned in this study can be used to improve the Healthy Start-Départ Santé intervention so that its implementation can be effectively expanded to childcare centres within and outside Saskatchewan, in turn, supporting the healthy development of early years (0-5) children in the province and beyond.","[{'ForeName': 'Amanda Froehlich', 'Initials': 'AF', 'LastName': 'Chow', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, 87 Campus Drive, Saskatoon, SK, S7N 5B2, Canada. a.froehlichchow@usask.ca.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Humbert', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, 87 Campus Drive, Saskatoon, SK, S7N 5B2, Canada.'}, {'ForeName': 'Nazeem', 'Initials': 'N', 'LastName': 'Muhajarine', 'Affiliation': 'Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Engler-Stringer', 'Affiliation': 'Department of Community Health and Epidemiology, University of Saskatchewan, Saskatoon, SK, Canada.'}]",Canadian journal of public health = Revue canadienne de sante publique,['10.17269/CJPH.107.5279'] 3403,31892277,Effects of Resistance Exercise on Glycated Hemoglobin and Functional Performance in Older Patients with Comorbid Diabetes Mellitus and Knee Osteoarthritis: A Randomized Trial.,"Type 2 diabetes mellitus (T2DM) is significantly associated with osteoarthritis (OA). This study investigated the effects of two resistance exercise approaches on glycated hemoglobin (HbA1c) level and function performance. Enrolled were 70 older patients with both T2DM and knee OA. The dynamic group performed resistance exercises with an elastic resistance band. The isometric group underwent isometric contraction exercises. After the 12-week intervention, a significant within-group improvement (all p < 0.001) was observed for the chair stand test (CST; 10.8%, vs. 7.1%), timed up and go (TUG) test (12.6% vs. 7.6%), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function subscale (62.3% vs. 36.1%), and overall WOMAC (54.5% vs. 34.5%) in the dynamic and isometric group, respectively. In addition, in terms of between-group differences, the dynamic group had significant improvements in CST ( p = 0.011), TUG ( p < 0.001), WOMAC physical function subscale ( p = 0.033), and overall WOMAC ( p = 0.036) scores compared with the isometric group. However, no significant change in HbA1c was observed in either group. In conclusion, the dynamic resistance exercise significantly improved muscle strength, dynamic balance, and physical function in this comorbid population; however, there was no notable difference in change in HbA1c among different resistance exercises.",2019,"After the 12-week intervention, a significant within-group improvement (all p < 0.001) was observed for the chair stand test (CST; 10.8%, vs. 7.1%), timed up and go (TUG) test (12.6% vs. 7.6%), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function subscale (62.3% vs. 36.1%), and overall WOMAC (54.5% vs. 34.5%) in the dynamic and isometric group, respectively.","['70 older patients with both T2DM and knee OA', 'Older Patients with Comorbid Diabetes Mellitus and Knee Osteoarthritis']","['resistance exercises', 'Resistance Exercise', 'resistance exercise approaches', 'isometric contraction exercises']","['glycated hemoglobin (HbA1c) level and function performance', 'muscle strength, dynamic balance, and physical function', 'Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function subscale', 'Glycated Hemoglobin and Functional Performance', 'CST', 'TUG', 'overall WOMAC', 'HbA1c', 'WOMAC physical function subscale', 'timed up and go (TUG) test']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}]","[{'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3853978'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",70.0,0.0274215,"After the 12-week intervention, a significant within-group improvement (all p < 0.001) was observed for the chair stand test (CST; 10.8%, vs. 7.1%), timed up and go (TUG) test (12.6% vs. 7.6%), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function subscale (62.3% vs. 36.1%), and overall WOMAC (54.5% vs. 34.5%) in the dynamic and isometric group, respectively.","[{'ForeName': 'Shu-Mei', 'Initials': 'SM', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Feng-Chih', 'Initials': 'FC', 'LastName': 'Shen', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Internal Medicine, Kaohsiung Chang Gung Hospital, Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Jung-Fu', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Internal Medicine, Kaohsiung Chang Gung Hospital, Chang Gung University College of Medicine, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Wen-Dien', 'Initials': 'WD', 'LastName': 'Chang', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sport, Taichung 404, Taiwan.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung, 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17010224'] 3404,1433118,Ceftazidime versus aminoglycoside and (ureido)penicillin combination in the empirical treatment of serious infection.,"Urgent treatment of serious infections with broad spectrum antibiotics usually starts before bacteriological evidence of the infective organism(s) becomes available. In this study 471 patients with a clinical diagnosis of sepsis were treated empirically with ceftazidime (CAZ) monotherapy (249 patients), or with an aminoglycoside+(ureido)penicillin combination (AG+PEN) (222 patients) to establish clinical outcome and bacteriological response. Up to 72 h post-treatment 94.5% of patients in the CAZ group and 93.8% in the AG+PEN group were treated successfully (treatment difference 0.7%, P < 0.01, 95% confidence interval -3.8%, 5.2%); 2-4 weeks after treatment neither regimen proved clinically superior. The differences in bacteriological response up to 72 h, and at 2-4 weeks after treatment, were 5.6% and 12.4% in favour of CAZ, however, these were not statistically significant. Overall, 56 patients reported 72 adverse events in the CAZ group, compared with 33 patients reporting 41 adverse events in the AG+PEN group. Deaths, 40 on CAZ and 21 on AG+PEN, were mainly related to their underlying condition. The two regimens were shown to be clinically equivalent in seriously ill patients treated empirically.",1992,"Up to 72 h post-treatment 94.5% of patients in the CAZ group and 93.8% in the AG+PEN group were treated successfully (treatment difference 0.7%, P < 0.01, 95% confidence interval -3.8%, 5.2%); 2-4 weeks after treatment neither regimen proved clinically superior.","['471 patients with a clinical diagnosis of sepsis', '249 patients), or with an']","['ceftazidime (CAZ) monotherapy', 'Ceftazidime versus aminoglycoside and (ureido)penicillin combination', 'CAZ', 'aminoglycoside+(ureido)penicillin combination (AG+PEN']","['bacteriological response', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0007559', 'cui_str': 'Ceftazidime'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}]","[{'cui': 'C0205465', 'cui_str': 'Bacteriologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",471.0,0.0730362,"Up to 72 h post-treatment 94.5% of patients in the CAZ group and 93.8% in the AG+PEN group were treated successfully (treatment difference 0.7%, P < 0.01, 95% confidence interval -3.8%, 5.2%); 2-4 weeks after treatment neither regimen proved clinically superior.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Finer', 'Affiliation': 'Luton and Dunstable Hospital.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Goustas', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3405,32016500,Impact of Dorsal Preservation Rhinoplasty Versus Dorsal Hump Resection on the Internal Nasal Valve: a Quantitative Radiological Study.,"BACKGROUND This study evaluates the impact of different hump takedown techniques, namely the conventional hump resection with midvault reconstruction, the push-down (PD) and the let-down (LD) procedures, on the INV dimensions. METHODS In this cadaveric study, six heads were divided randomly into either the conventional hump resection technique (Group A; n = 6 sides) or DPR techniques (n = 6 sides). This latter group was subdivided such that initially a PD procedure was performed (Group B; n = 6 sides), followed by a LD procedure on the same heads (Group C; n = 6 sides). A validated radiological method was used to measure the INV angle and cross-sectional area (CSA) in a modified coronal plane both pre- and post-procedurally. RESULTS Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively). In the push-down group (B), we observed a mean change of 2.05° in the angles and 0.3 cm 2 in the CSA (p = 0.0163 and p < 0.001, respectively). The LD group (C) did not show significant reduction in the INV angle nor in CSA (p = 0.437 and p = 0.331, respectively). CONCLUSION Neither the conventional hump resection nor the LD DPR technique reduced the INV dimensions. However, the PD preservation technique significantly reduced the INV dimensions. LEVEL OF EVIDENCE III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,"RESULTS Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively).",[],"['conventional hump resection technique (Group A; n\u2009=\u20096 sides) or DPR techniques', 'Dorsal Preservation Rhinoplasty', 'conventional hump resection with midvault reconstruction, the push-down (PD) and the let-down (LD) procedures', 'Dorsal Hump Resection']","['INV angle nor in CSA', 'INV angle and cross-sectional area (CSA', 'INV dimensions']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",6.0,0.0172006,"RESULTS Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively).","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdelwahab', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Caio A', 'Initials': 'CA', 'LastName': 'Neves', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Priyesh N', 'Initials': 'PN', 'LastName': 'Patel', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA. smost@stanford.edu.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01627-z'] 3406,32008420,Nomogram predicting cancer-specific survival in elderly patients with stages I-III colon cancer.,"Aim: This study aims to establish and validate an effective nomogram to predict cancer-specific survival (CSS) in elderly patients with stages I-III colon cancer. Methods: The data of elderly colon cancer patients with stages I-III were enrolled from the Surveillance, Epidemiology, and End Results database (SEER) between 2010 and 2015. The eligible patients were randomly divided into a training cohort and a validation cohort (ratio 1:1). All predictors of cancer-specific survival were determined by Cox regression. The concordance index (C-index) and calibration curves were used for validation of nomograms. Decision curve analysis (DCA) was performed to evaluate the clinical net benefit of the nomogram. Results: Cox hazard analysis in the training cohort indicated that grade, tumor stage, node stage, colectomy, and CEA were independent predictors of CSS. Nomogram was constructed based on these predictors. The C-index of nomograms for CSS was 0.728 (95%CI: 0.7133-0.7427), and were superior to that of AJCC TNM Stage (C-index: 0.625, 95%CI: 0.6093-0.6406). The calibration curves showed satisfactory consistency between actual observation and nomogram-predicted CSS probabilities. The validation cohort demonstrated similar results. The DCA showed high net benefit of nomogram in a clinical context. The population was divided into three groups based on the scores of the nomogram, and the survival analysis showed that this prognostic stratification was statistically significant ( p  < 0.01). Conclusion: The nomograms showed significant accuracy in predicting 1-, 3-, and 5-year CSS in elderly patients with stages I-III colon cancer and may be helpful inpatient counseling clinical decision guidance.",2020,The C-index of nomograms for CSS was 0.728,"['elderly patients with stages I-III colon cancer', 'elderly colon cancer patients with stages I-III were enrolled from the Surveillance, Epidemiology, and End Results database (SEER) between 2010 and 2015']",['95%CI'],"['cancer-specific survival (CSS', 'cancer-specific survival', 'concordance index (C-index) and calibration curves']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0337485,The C-index of nomograms for CSS was 0.728,"[{'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lai', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Shihan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Zhikang', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal and Anus Surgery, Xiangya Hospital of Central South University, Changsha, China.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1720280'] 3407,32012257,A Randomized Comparison of Two Psychosocial Interventions on Family Functioning in Adolescents with Bipolar Disorder.,"Impairments in family functioning are associated with more severe depressive and manic symptoms, earlier recurrences, and more suicidal behaviors in early-onset bipolar disorder. This study examined whether family-focused treatment for adolescents (FFT-A) with BD I or II disorder led to greater increases in family cohesion and adaptability and decreases in conflict over 2 years compared to a briefer psychoeducational treatment (enhanced care, EC). Participants were 144 adolescents (mean age: 15.6 ± 1.4 years) with BD I or II with a mood episode in the previous 3 months. Adolescents and parents were randomized to either FFT-A (21 sessions) or EC (three sessions). Patients received guideline-based pharmacotherapy throughout the 2-year study. Trajectories of adolescent- and parent-rated family cohesion, adaptability, and conflict were analyzed over 2 years. FFT-A had greater effects on adolescent-rated family cohesion compared to EC over 2 years. Participants in FFT-A and EC reported similar improvements in family conflict across the 2 years. In the FFT-A group, low-conflict families had greater adolescent-rated family cohesion throughout the study compared to high-conflict families. High-conflict families in both treatment groups tended to show larger reductions in conflict over 2 years than low-conflict families. Family psychoeducation and skills training may improve family cohesion in the early stages of BD. Measuring levels of family conflict at the start of treatment may inform treatment responsiveness among those receiving FFT-A.",2020,High-conflict families in both treatment groups tended to show larger reductions in conflict over 2 years than low-conflict families.,"['Adolescents and parents', 'adolescents (FFT-A) with BD I or II disorder', 'Participants were 144 adolescents (mean age: 15.6\xa0±\xa01.4\xa0years) with BD I or II with a mood episode in the previous 3\xa0months', 'Adolescents with Bipolar Disorder']","['FFT-A (21 sessions) or EC', 'Family psychoeducation and skills training', 'guideline-based pharmacotherapy', 'Two Psychosocial Interventions']","['suicidal behaviors', 'family conflict', 'Trajectories of adolescent- and parent-rated family cohesion, adaptability, and conflict', 'Measuring levels of family conflict', 'severe depressive and manic symptoms, earlier recurrences']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0233542', 'cui_str': 'Family conflict (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",144.0,0.0226527,High-conflict families in both treatment groups tended to show larger reductions in conflict over 2 years than low-conflict families.,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': ""O'Donnell"", 'Affiliation': 'School of Social Work, Wayne State University, Detroit, MI.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry, Semel Institute, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Alissa J', 'Initials': 'AJ', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychiatry, Semel Institute, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Axelson', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Kowatch', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry, Semel Institute, University of California, Los Angeles, Los Angeles, CA.'}]",Family process,['10.1111/famp.12521'] 3408,32017253,Effect of curcumin supplementation on disease severity in patients with liver cirrhosis: A randomized controlled trial.,"Recent reports indicated that curcumin had beneficial effects in animal models of liver injury and cirrhosis. Current study aimed to investigate the effects of curcumin supplementation in patients with liver cirrhosis. In this randomized double-blind placebo-controlled trial, 70 patients with liver cirrhosis aged 20-70 years were randomly divided into two groups to receive 1,000 mg/day curcumin (n = 35) or placebo (n = 35) for 3 months. Model for end-stage liver disease (MELD) (i), MELD, MELD-Na, and Child-Pugh scores were used to assess the severity of cirrhosis. Sixty patients (29 in the curcumin group and 31 in the placebo group) completed the study. MELD(i) (15.55 ± 3.78 to 12.41 ± 3.07), MELD (15.31 ± 3.07 to 12.03 ± 2.79), MELD-Na (15.97 ± 4.02 to 13.55 ± 3.51), and Child-Pugh (7.17 ± 1.54 to 6.72 ± 1.31) scores decreased significantly in the curcumin group after 3-month intervention (p < .001, p < .001, p = .001, and p = .051, respectively), whereas they increased significantly in the placebo group (p < .001, p < .001, p < .001, p = .001, respectively). Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-Pugh scores after 3-month intervention (p < .001 for all of them). In this pilot study, beneficial effects of curcumin supplementation were observed in decreasing disease activity scores and severity of cirrhosis in patients with cirrhosis.",2020,"Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-","['patients with liver cirrhosis', 'end-stage liver disease (MELD', 'Sixty patients (29 in the curcumin group and 31 in the placebo group) completed the study', '70 patients with liver cirrhosis aged 20-70\u2009years', 'patients with cirrhosis']","['curcumin supplementation', 'placebo', 'MELD(i']","['MELD(i), MELD, MELD-Na, and Child', 'disease activity scores and severity of cirrhosis', 'i), MELD, MELD-Na, and Child', 'Pugh scores', 'disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",70.0,0.210468,"Significant differences were only observed between the two groups in MELD(i), MELD, MELD-Na, and Child-","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Nouri-Vaskeh', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Malek Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Afshan', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Alizadeh', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zarei', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Perlman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Phytotherapy research : PTR,['10.1002/ptr.6620'] 3409,32009091,Lenalidomide Treatment for Thalidomide-refractory POEMS Syndrome: A Prospective Single-arm Clinical Trial.,"Objective A randomized controlled trial has shown the efficacy of thalidomide against polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; however, there are still refractory patients. We studied the effects of lenalidomide, a derivative of thalidomide, on patients refractory to thalidomide. Methods This prospective single-arm trial evaluated the safety and efficacy of lenalidomide plus dexamethasone in refractory or recurrent patients with POEMS syndrome. The regimen was administered as six 28-day cycles with lenalidomide on days 1-21 (15 mg in cycle 1, and 25 mg in cycle 2-6) plus dexamethasone once a week (20 mg). The primary endpoints were the rate of reduction in the serum vascular endothelial growth factor (VEGF) level at 24 weeks and the incidence of adverse events. This trial was registered with ClinicalTrial.gov, NCT02193698. Results Between July 2014 and December 2015, five men were enrolled. All patients had been refractory to thalidomide plus dexamethasone for more than 24 weeks. The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003). The mean serum VEGF level decreased from 2,466±771 pg/mL to 974±340 pg/mL. No serious adverse events were observed, and all patients completed six cycles treatment. Discussion Lenalidomide is a therapeutic option for thalidomide-refractory patients with POEMS syndrome.",2020,The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003).,"['recurrent patients with POEMS syndrome', 'refractory POEMS Syndrome', 'Results Between July 2014 and December 2015, five men were enrolled', 'refractory patients with POEMS syndrome']","['dexamethasone', 'Lenalidomide', 'thalidomide plus dexamethasone', 'lenalidomide plus dexamethasone', 'lenalidomide', 'Thalidomide', 'thalidomide']","['serious adverse events', 'incidence of adverse events', 'mean rate of reduction in the serum VEGF level', 'safety and efficacy', 'mean serum VEGF level', 'rate of reduction in the serum vascular endothelial growth factor (VEGF) level']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085404', 'cui_str': 'Crow-Fukase Syndrome'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",5.0,0.185052,The mean rate of reduction in the serum VEGF level at 24 weeks was 59.6%±8.3% (p=0.0003).,"[{'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Suichi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Sonoko', 'Initials': 'S', 'LastName': 'Misawa', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Keio University, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Iwai', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Sekiguchi', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Shibuya', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Amino', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Yo-Ichi', 'Initials': 'YI', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Tsuneyama', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.3800-19'] 3410,31902864,"Effect of Tryptophan, Vitamin B 6 , and Nicotinamide-Containing Supplement Loading between Meals on Mood and Autonomic Nervous System Activity in Young Adults with Subclinical Depression: A Randomized, Double-Blind, and Placebo-Controlled Study.","Tryptophan (TRP), a precursor of serotonin is believed to have an antidepressant effect. The pathway for brain uptake of TRP is shared by other large neutral amino acids; therefore, the best time to take TRP may be between meals. No previous study has, however, designated the time of TRP dosing to improve mood. Further, the effects of TRP on autonomic nervous system (ANS) activity are unclear. This study investigated the effects of TRP, vitamin B 6 , and nicotinamide-containing supplements loading between meals on mood and ANS activity in depressive young adults. Thirty depressive young adults were randomly allocated to receive TRP, vitamin B 6 , and nicotinamide-containing supplements or a placebo supplements twice daily between meals for 7 d. Mood was measured using the Center for Epidemiologic Studies Depression Scale (CES-D) and the Profile of Mood States (POMS). ANS activities were analyzed by heart rate variability power spectral analysis. Blood samples were assayed for plasma total TRP concentration. For analysis, TRP and placebo groups were further classified into two subgroups according to CES-D score (mild to moderate vs. severe depressive symptoms). The CES-D score significantly improved following both treatments in the severe depression subgroups, while the POMS depression score was significantly improved only in the TRP severe depression subgroup. There was no significant change in ANS activity or plasma total TRP in any group. TRP, vitamin B 6 , and nicotinamide-containing supplements loading between meals can quickly improve depressed mood in quite low dose in young adults with severe subclinical depression.",2019,"The CES-D score significantly improved following both treatments in the severe depression subgroups, while the POMS depression score was significantly improved only in the TRP severe depression subgroup.","['Young Adults with Subclinical Depression', 'young adults with severe subclinical depression', 'Thirty depressive young adults', 'depressive young adults']","['Tryptophan (TRP', 'Placebo', 'TRP, vitamin B 6 , and nicotinamide-containing supplements loading between meals', 'TRP', 'TRP, vitamin B 6 , and nicotinamide-containing supplements or a placebo supplements', 'Tryptophan, Vitamin B 6 , and Nicotinamide-Containing Supplement Loading between Meals']","['CES-D score', 'ANS activity or plasma total TRP', 'plasma total TRP concentration', 'POMS depression score']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0028027', 'cui_str': 'nicotinamide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0587121', 'cui_str': 'Between meals (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",30.0,0.178371,"The CES-D score significantly improved following both treatments in the severe depression subgroups, while the POMS depression score was significantly improved only in the TRP severe depression subgroup.","[{'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Tsujita', 'Affiliation': 'Graduate School of Human and Environmental Studies, Kyoto University.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Akamatsu', 'Affiliation': 'Graduate School of Human and Environmental Studies, Kyoto University.'}, {'ForeName': 'Márcio Makoto', 'Initials': 'MM', 'LastName': 'Nishida', 'Affiliation': 'Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Human and Environmental Studies, Kyoto University.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Moritani', 'Affiliation': 'Graduate School of Human and Environmental Studies, Kyoto University.'}]",Journal of nutritional science and vitaminology,['10.3177/jnsv.65.507'] 3411,650647,Grommets and glue ear: a five-year follow up of a controlled trial.,,1978,,[],[],[],[],[],[],,0.0392016,,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Ambegaokar', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3412,31895303,"The Effect of Kangaroo Mother Care, Provided in the Early Postpartum Period, on the Breastfeeding Self-Efficacy Level of Mothers and the Perceived Insufficient Milk Supply.","The aim of this study was to determine the effect of kangaroo mother care, provided in the early postpartum period, on the breastfeeding self-efficacy level and the perceived insufficient milk supply. This study was conducted as the quasi-experimental design. The population of the study consisted of the mothers and their infants, to whom they gave birth in a university hospitals located in either eastern or western Turkey, between December 2016 and June 2017. In this study, mothers and their infants were randomly assigned to the experimental group (kangaroo mother care, n = 30) and the control group (n = 30). This study included 2500 to 4000 g birth weight infants who had no serious health problems and no sucking problems. The Introductory Information Form, the Breastfeeding Self-Efficacy Scale, and the Perception of Insufficient Milk Questionnaire were used to collect the data. In this study, kangaroo mother care was provided as a nursing intervention for the mothers in the experimental group twice a day until they were discharged. Any other application was not performed in the control group's mothers apart from the routine application. Ethical principles were adhered in all stages of the study. The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00) (P < .001). In addition, mothers in the experimental group (46.60 ± 3.40) perceived their milk more sufficiently than mothers in the control group (30.17 ± 11.37) (P < .001). In the study, a statistically significant correlation was determined between breastfeeding self-efficacy levels of mothers in the experimental group and the perceived insufficient milk supply (P < .05). In the study, kangaroo mother care increased breastfeeding self-efficacy perception of the mothers and reduced the perceived insufficient milk supply. This shows that kangaroo mother care can potentially have an important effect on breastfeeding perceptions.",2020,The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00),"['mothers and their infants', 'mothers and their infants, to whom they gave birth in a university hospitals located in either eastern or western Turkey, between December 2016 and June 2017', '2500 to 4000 g birth weight infants who had no serious health problems and no sucking problems']",[],"['breastfeeding self-efficacy perception', 'breastfeeding self-efficacy mean score', 'breastfeeding self-efficacy levels']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0677049', 'cui_str': 'Does suck (finding)'}]",[],"[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0179342,The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00),"[{'ForeName': 'Fatma Yılmaz', 'Initials': 'FY', 'LastName': 'Kurt', 'Affiliation': 'Department of Children Health and Diseases Nursing, Faculty of Nursing, Çanakkale Onsekiz Mart University, Turkey (Dr Yilmaz and Mr Oğul); Department of Children Health and Diseases Nursing, Faculty of Nursing, Selcuk University, Konya, Turkey (Dr Küçükoglu); Department of Nursing, Faculty of Health Sciences, Istanbul Medeniyet University, Istanbul, Turkey (Dr Aytekin Ozdemir); and Çanakkale Obstetrics and Gynecology Clinic, Health Practice and Research Hospital, Turkey (Ms Aski).'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Küçükoğlu', 'Affiliation': ''}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Aytekin Özdemir', 'Affiliation': ''}, {'ForeName': 'Tanju', 'Initials': 'T', 'LastName': 'Oğul', 'Affiliation': ''}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Aşki', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000434'] 3413,32000630,Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial.,"Intensive antithrombotic therapy reduces major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Recent studies have suggested heterogeneity in risk and benefit in those with and without concomitant coronary artery disease (CAD) and peripheral revascularization. We evaluated the risk of MACE and MALE in patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization and whether the efficacy and safety of vorapaxar were similar in these subgroups. The TRA 2°P-TIMI 50 trial randomized 26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or placebo. This analysis examined the effect of vorapaxar in a broad population of 6136 patients with PAD. Overall, vorapaxar significantly reduced MACE (HR 0.85, 95% CI 0.73, 0.99; p = 0.034) and MALE (HR 0.70, 95% CI 0.53, 0.92; p = 0.011) in patients with PAD. The absolute risk reduction (ARR) for MACE was greater in patients with PAD and CAD versus those with PAD alone (-2.2% vs 0.1%: number needed to treat (NNT) 45 vs 1000). Conversely, the ARR for MALE was higher in those with prior lower extremity revascularization (2.5% vs 0.2%: NNT 40 vs 500). Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003). The net clinical outcome in all patients with PAD was reduced with vorapaxar (HR 0.82, 95% CI 0.72, 0.94; p = 0.004), with benefits driven by reductions in MACE for those with CAD and by reductions in MALE for those with prior peripheral revascularization. Among patients with PAD, vorapaxar resulted in a net clinical benefit; however, the drivers of benefit were heterogeneous, with greater reductions in MACE in those with concomitant CAD and greater reductions in MALE in those with prior lower extremity revascularization, and unclear benefit in patients with neither. These clinical characteristics may be useful in identifying the subgroups of patients with PAD most likely to benefit from potent antithrombotic therapies. ClinicalTrials.gov Identifier: NCT00526474 .",2020,"Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003).","['patients with peripheral artery disease (PAD', 'patients with peripheral artery disease with and without coronary artery disease', '26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or', 'patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization', '6136 patients with PAD']","['placebo', 'MACE', 'Intensive antithrombotic therapy', 'vorapaxar']","['cardiovascular and limb outcomes', 'efficacy and safety of vorapaxar', 'major bleeding', 'extremity revascularization', 'absolute risk reduction (ARR) for MACE', 'ARR for MALE', 'major adverse cardiovascular events (MACE) and major adverse limb events (MALE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",26449.0,0.195795,"Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Creager', 'Affiliation': 'Dartmouth-Hitchcock Heart and Vascular Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Olin', 'Affiliation': 'Zena and Michael A Weiner Cardiovascular Institute and Marie-Jose and Henry R Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Beckman', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]","Vascular medicine (London, England)",['10.1177/1358863X19892690'] 3414,31504848,Habit-based workplace physical activity intervention: a pilot study.,"BACKGROUND Increasing workplace physical activity has important implications for workers' health and well-being. However, few interventions targeting physical activity in the workplace are grounded in behavioural theory. AIMS The aim of this study was to develop and pilot a 6-week habit-based intervention designed to promote the development of workplace physical activity habits and increase average weekly step counts. Changes in the strength of workplace physical activity habit and weekly step counts were assessed at 1 and 6 weeks following the intervention. METHODS The study was a prospective three-wave within-subjects single-arm intervention study that ran for 12 weeks (baseline, 7 weeks, 12 weeks). During the 6-week intervention, participants received information regarding 10 top tips (10TT) to increase and promote habit formation and wore a pedometer during work hours. Differences in workplace physical activity habit and weekly step counts were compared across baseline (T1), 1 (T2) and 6 weeks (T3) post-intervention using repeated measures analyses of variance. RESULTS Data from 20 sedentary office workers at a large Australian University were included. The average strength of workplace physical activity habits significantly increased from baseline (M = 3.90) to 1 week post-intervention (M = 4.45), and these effects were maintained 6 weeks later (M = 4.72). No significant increase in step counts were observed across any of the time points (all P > 0.05). CONCLUSIONS The results of this pilot study reveal that workplace physical activity habits can be strengthened via a habit-based intervention. Further research is needed to replicate these findings in larger cohorts of office workers.",2019,"Changes in the strength of workplace physical activity habit and weekly step counts were assessed at 1 and 6 weeks following the intervention. ",['20 sedentary office workers at a large Australian University were included'],"['Habit-based workplace physical activity intervention', 'information regarding 10 top tips (10TT) to increase and promote habit formation and wore a pedometer during work hours']","['workplace physical activity habit and weekly step counts', 'strength of workplace physical activity habit and weekly step counts', 'workplace physical activity habits', 'average strength of workplace physical activity habits', 'step counts']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",10.0,0.0240846,"Changes in the strength of workplace physical activity habit and weekly step counts were assessed at 1 and 6 weeks following the intervention. ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology and Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fraser', 'Affiliation': 'School of Applied Psychology and Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hannan', 'Affiliation': 'School of Applied Psychology and Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}]","Occupational medicine (Oxford, England)",['10.1093/occmed/kqz119'] 3415,31836545,Beyond the bladder: poor sleep in women with overactive bladder syndrome.,"BACKGROUND Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population. OBJECTIVES To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder. STUDY DESIGN We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5. RESULTS Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences. CONCLUSIONS Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.",2020,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences. ","['women with overactive bladder', 'middle-aged and older women', 'Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence', 'women with overactive bladder syndrome', '161 women randomized', 'women with overactive bladder symptoms']","['slow-paced respiration', 'Guided slow-paced respiration', 'portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing', 'guided slow-paced respiration intervention']","['mean nocturnal voiding frequency', 'sleep outcomes', 'average sleep quality', 'nighttime awakenings', 'bladder symptoms', 'nocturia frequency and sleep quality', 'sleep quality', 'nocturnal bladder symptoms', 'voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality', 'Pittsburgh Sleep Quality Index global score >5', 'sleep disruption']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}]",161.0,0.110217,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences. ","[{'ForeName': 'Marissa B', 'Initials': 'MB', 'LastName': 'Savoie', 'Affiliation': 'School of Medicine, University of California San Francisco, CA. Electronic address: marissa.savoie@ucsf.edu.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Lee', 'Affiliation': 'Department of Family Health Care Nursing, University of California San Francisco, CA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, CA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schembri', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, CA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine, University of California at Los Angeles, CA; VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.005'] 3416,31994278,"Ilex paraguariensis, white mulberry and chromium picolinate in patients with pre-diabetes.","AIM to evaluate if a nutraceutical compound containing Ilex paraguariensis, White Mulberry and Chromium Picolinate can ameliorate glycemic status in patients with pre-diabetes. METHODS we enrolled patients with IFG or IGT, not taking other hypoglycemic compounds. Patients were randomized to take placebo or the nutraceutical compound for 3 months, in a randomized, double-blind, placebo-controlled design. Both treatments were self-administered once a day, 1 tablet during the breakfast. RESULTS a reduction of FPG was observed with the nutraceutical combination (-7.8%). Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%). M value was higher (p < 0.05 vs baseline and p < 0.05 vs placebo) at the end of the treatment. We obtained a reduction of Tg with the nutraceutical combination (-8.3%). About 16.6% of patients treated with nutraceutical returned to have a normal glycemia (< 100 mg/dL), and all patients had an improvement of insulin-resistance, in particular 67% of patients returned to have a M value inside range of normal insulin sensitivity. CONCLUSIONS a nutraceutical containing Ilex paraguariensis, White Mulberry and Chromium Picolinate at 500 mg can be helpful in improving glycemia and Tg value, in patients with pre-diabetes.",2020,"Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%).","['patients with pre-diabetes', 'enrolled patients with IFG or IGT, not taking other hypoglycemic compounds']","['Ilex paraguariensis, white mulberry and chromium picolinate', 'placebo', 'nutraceutical compound containing Ilex paraguariensis, White Mulberry and Chromium Picolinate', 'Chromium Picolinate']","['FPG', 'insulin-resistance', 'normal glycemia', 'M value', 'glycemic status', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}]","[{'cui': 'C0874159', 'cui_str': 'Ilex paraguariensis'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0330540', 'cui_str': 'Mulberry'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1518478', 'cui_str': 'Nutraceuticals'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.137981,"Furthermore, there was a decrease of HOMA-IR with the nutraceutical combination (-7.9%).","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, PAVIA, Italy.'}]",Phytotherapy research : PTR,['10.1002/ptr.6611'] 3417,31345626,Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial.,"BACKGROUND The PORTEC-3 trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We updated the analysis to investigate patterns of recurrence and did a post-hoc survival analysis. METHODS In the multicentre randomised phase 3 PORTEC-3 trial, women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO) 2009 stage I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2. Participants were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m 2 given intravenously), by use of a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage, and histological type. The co-primary endpoints were overall survival and failure-free survival. Secondary endpoints of vaginal, pelvic, and distant recurrence were analysed according to the first site of recurrence. Survival endpoints were analysed by intention-to-treat, and adjusted for stratification factors. Competing risk methods were used for failure-free survival and recurrence. We did a post-hoc analysis to analyse patterns of recurrence with 1 additional year of follow-up. The study was closed on Dec 20, 2013; follow-up is ongoing. This study is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. FINDINGS Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group). At a median follow-up of 72·6 months (IQR 59·9-85·6), 5-year overall survival was 81·4% (95% CI 77·2-85·8) with chemoradiotherapy versus 76·1% (71·6-80·9) with radiotherapy alone (adjusted hazard ratio [HR] 0·70 [95% CI 0·51-0·97], p=0·034), and 5-year failure-free survival was 76·5% (95% CI 71·5-80·7) versus 69·1% (63·8-73·8; HR 0·70 [0·52-0·94], p=0·016). Distant metastases were the first site of recurrence in most patients with a relapse, occurring in 78 of 330 women (5-year probability 21·4%; 95% CI 17·3-26·3) in the chemoradiotherapy group versus 98 of 330 (5-year probability 29·1%; 24·4-34·3) in the radiotherapy-alone group (HR 0·74 [95% CI 0·55-0·99]; p=0·047). Isolated vaginal recurrence was the first site of recurrence in one patient (0·3%; 95% CI 0·0-2·1) in both groups (HR 0·99 [95% CI 0·06-15·90]; p=0·99), and isolated pelvic recurrence was the first site of recurrence in three women (0·9% [95% CI 0·3-2·8]) in the chemoradiotherapy group versus four (0·9% [95% CI 0·3-2·8]) in the radiotherapy-alone group (HR 0·75 [95% CI 0·17-3·33]; p=0·71). At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group). At 5 years, reported grade 3 adverse events did not differ significantly between the two groups, occurring in 16 (8%) of 201 women in the chemoradiotherapy group versus ten (5%) of 187 in the radiotherapy-alone group (p=0·24). The most common grade 3 adverse event was hypertension (in four [2%] women in both groups). At 5 years, grade 2 or worse adverse events were reported in 76 (38%) of 201 women in the chemoradiotherapy group versus 43 (23%) of 187 in the radiotherapy-alone group (p=0·002). Sensory neuropathy persisted more often after chemoradiotherapy than after radiotherapy alone, with 5-year rates of grade 2 or worse neuropathy of 6% (13 of 201 women) versus 0% (0 of 187). No treatment-related deaths were reported. INTERPRETATION This updated analysis shows significantly improved overall survival and failure-free survival with chemoradiotherapy versus radiotherapy alone. This treatment schedule should be discussed and recommended, especially for women with stage III or serous cancers, or both, as part of shared decision making between doctors and patients. Follow-up is ongoing to evaluate long-term survival. FUNDING Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council, Project Grant, Cancer Australia Grant, Italian Medicines Agency, and the Canadian Cancer Society Research Institute.",2019,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","['2009 stage', 'women with high-risk endometrial cancer (PORTEC-3', 'I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2', '0·70', 'women with high-risk endometrial cancer', 'women with stage III or serous cancers', 'Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group', 'women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO']","['radiotherapy-alone group (HR 0·75', 'combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone', 'Adjuvant chemoradiotherapy versus radiotherapy alone', 'chemoradiotherapy versus radiotherapy', 'radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel', 'radiotherapy', 'chemoradiotherapy']","['grade 2 or worse adverse events', '5-year rates of grade 2 or worse neuropathy', 'vaginal, pelvic, and distant recurrence', 'Isolated vaginal recurrence', 'grade 3 adverse events', 'overall survival and failure-free survival', 'Sensory neuropathy', '5-year overall survival', 'grade 4 adverse event (ileus or obstruction', 'Survival endpoints', '5-year failure-free survival', 'isolated pelvic recurrence']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C4081040', 'cui_str': 'Cisplatin 50 MG [Platinol]'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",686.0,0.472097,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Department of Clinical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Dionyssios', 'Initials': 'D', 'LastName': 'Katsaros', 'Affiliation': 'Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Canadian Cancer Trials Group, Department of Obstetrics and Gynaecology, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Pearly', 'Initials': 'P', 'LastName': 'Khaw', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Romerai', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Division of Radiation Oncology, ASST-Lecco, Ospedale AManzoni, Lecco, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Canadian Cancer Trials Group, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Marie-Helene', 'Initials': 'MH', 'LastName': 'Baron', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jürgenliemk-Schulz', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Pathology, Central Manchester Hospitals NHS Foundation Trust, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Gribaudo', 'Affiliation': 'Department of Oncology - Radiotherapy, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': 'Department of Gynaecologic Oncology, Hôpital Notre-Dame de Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Hanzen', 'Affiliation': 'Department of Radiation Oncology, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Kruitwagen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht, Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Naveena', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Cellular Pathology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Viet', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Department of Radiation Oncology, Liverpool Cancer Therapy Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Comprehensive Cancer Center Netherlands, Rotterdam, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30395-X'] 3418,31345627,"Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study.","BACKGROUND Pembrolizumab improved progression-free survival and overall survival versus ipilimumab in patients with advanced melanoma and is now a standard of care in the first-line setting. However, the optimal duration of anti-PD-1 administration is unknown. We present results from 5 years of follow-up of patients in KEYNOTE-006. METHODS KEYNOTE-006 was an open-label, multicentre, randomised, controlled, phase 3 study done at 87 academic institutions, hospitals, and cancer centres in 16 countries. Patients aged at least 18 years with Eastern Cooperative Oncology Group performance status of 0 or 1, ipilimumab-naive histologically confirmed advanced melanoma with known BRAF V600 status and up to one previous systemic therapy were randomly assigned (1:1:1) to intravenous pembrolizumab 10 mg/kg every 2 weeks or every 3 weeks or four doses of intravenous ipilimumab 3 mg/kg every 3 weeks. Treatments were assigned using a centralised, computer-generated allocation schedule with blocked randomisation within strata. Exploratory combination of data from the two pembrolizumab dosing regimen groups was not protocol-specified. Pembrolizumab treatment continued for up to 24 months. Eligible patients who discontinued pembrolizumab with stable disease or better after receiving at least 24 months of pembrolizumab or discontinued with complete response after at least 6 months of pembrolizumab and then progressed could receive an additional 17 cycles of pembrolizumab. Co-primary endpoints were overall survival and progression-free survival. Efficacy was analysed in all randomly assigned patients, and safety was analysed in all randomly assigned patients who received at least one dose of study treatment. Exploratory assessment of efficacy and safety at 5 years' follow-up was not specified in the protocol. Data cutoff for this analysis was Dec 3, 2018. Recruitment is closed; the study is ongoing. This study is registered with ClinicalTrials.gov, number NCT01866319. FINDINGS Between Sept 18, 2013, and March 3, 2014, 834 patients were enrolled and randomly assigned to receive pembrolizumab (every 2 weeks, n=279; every 3 weeks, n=277), or ipilimumab (n=278). After a median follow-up of 57·7 months (IQR 56·7-59·2) in surviving patients, median overall survival was 32·7 months (95% CI 24·5-41·6) in the combined pembrolizumab groups and 15·9 months (13·3-22·0) in the ipilimumab group (hazard ratio [HR] 0·73, 95% CI 0·61-0·88, p=0·00049). Median progression-free survival was 8·4 months (95% CI 6·6-11·3) in the combined pembrolizumab groups versus 3·4 months (2·9-4·2) in the ipilimumab group (HR 0·57, 95% CI 0·48-0·67, p<0·0001). Grade 3-4 treatment-related adverse events occurred in 96 (17%) of 555 patients in the combined pembrolizumab groups and in 50 (20%) of 256 patients in the ipilimumab group; the most common of these events were colitis (11 [2%] vs 16 [6%]), diarrhoea (ten [2%] vs seven [3%]), and fatigue (four [<1%] vs three [1%]). Any-grade serious treatment-related adverse events occurred in 75 (14%) patients in the combined pembrolizumab groups and in 45 (18%) patients in the ipilimumab group. One patient assigned to pembrolizumab died from treatment-related sepsis. INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up. These results provide further support for use of pembrolizumab in patients with advanced melanoma. FUNDING Merck Sharp & Dohme.",2019,"INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up.","['patients with advanced melanoma', 'Eligible patients who discontinued pembrolizumab with stable disease or better after receiving at least 24 months of pembrolizumab or discontinued with complete response after at least 6 months of', 'Between Sept 18, 2013, and March 3, 2014, 834 patients', '87 academic institutions, hospitals, and cancer centres in 16 countries', 'Patients aged at least 18 years with Eastern Cooperative Oncology Group performance status of 0 or 1, ipilimumab-naive histologically confirmed advanced melanoma with known BRAF V600 status and up to one previous systemic therapy']","['Pembrolizumab', 'intravenous ipilimumab', 'pembrolizumab', 'ipilimumab', 'intravenous pembrolizumab', 'Pembrolizumab versus ipilimumab']","['fatigue', 'diarrhoea', 'adverse events', 'progression-free survival and overall survival', 'efficacy and safety', 'overall survival and progression-free survival', 'Median progression-free survival', 'Efficacy', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",834.0,0.382841,"INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institut de Cancérologie Gustave Roussy, Université Paris-Sud, Villejuif, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Sheba Medical Center at Tel HaShomer, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille Université, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Université Lille, Centre Hospitalier Regional Universitaire de Lille, Lille, France.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse, Royal Prince Alfred Hospital, and Melanoma Institute Australia, Camperdown, NSW, Australia.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Lotem', 'Affiliation': 'Sharett Institute of Oncology, Hadassah Hebrew Medical Center, Jerusalem, Israel.'}, {'ForeName': 'James M G', 'Initials': 'JMG', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'University of Manchester and the Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Petrella', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Mater Hospital, and Royal North Shore Hospital, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30388-2'] 3419,31994752,Advanced decision-making using patient-reported outcome measures in total joint replacement.,"Up to one-third of total joint replacement (TJR) procedures may be performed inappropriately in a subset of patients who remain dissatisfied with their outcomes, stressing the importance of shared decision-making. Patient-reported outcome measures capture physical, emotional, and social aspects of health and wellbeing from the patient's perspective. Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision-making process. We have created a shared decision-making tool which generates personalized predictions of risks and benefits from TJR based on patient-reported outcomes as well as clinical and demographic data. We present the protocol for a randomized controlled trial designed to assess the impact of this tool on decision quality, level of shared decision-making, and patient and process outcomes. We also discuss current concepts in this field and highlight opportunities leveraging patient-reported data and artificial intelligence for decision support across the care continuum.",2020,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.",[],['total joint replacement (TJR) procedures'],"['capture physical, emotional and social aspects of health and wellbeing', 'Total Joint Replacement']",[],"[{'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4279925', 'cui_str': 'Total Joint Replacement'}]",,0.0738654,"Powerful computer systems capable of performing highly sophisticated analysis using different types of data, including patient-derived data, such as patient-reported outcomes, may eliminate guess work, generating impactful metrics to better inform the decision making process.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Jayakumar', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Bozic', 'Affiliation': 'Department of Surgery and Perioperative Care, Dell Medical School, University of Texas at Austin, Austin, Texas.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24614'] 3420,31344674,Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study.,"BACKGROUND Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. OBJECTIVE The aim of this study is to describe the protocol to pilot a mobile app-based mental health intervention in breast cancer patients and caregivers. METHODS The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies. RESULTS This study is ongoing, and recruitment will be completed by the end of 2018. CONCLUSIONS Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones. TRIAL REGISTRATION ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/11452.",2019,"There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. ","['breast cancer patients and caregivers', 'Breast Cancer Patients and Their Caregivers in the United States', '50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center']",['mobile app-based mental health intervention'],[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],50.0,0.133731,"There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. ","[{'ForeName': 'Philip I', 'Initials': 'PI', 'LastName': 'Chow', 'Affiliation': 'Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Shayna L', 'Initials': 'SL', 'LastName': 'Showalter', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Gerber', 'Affiliation': 'Department of Systems Engineering, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kennedy', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Brenin', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Anneke T', 'Initials': 'AT', 'LastName': 'Schroen', 'Affiliation': 'Department of Surgery, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Department of Medical Social Sciences and Psychiatry and Behavioral Sciences, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'Lattie', 'Affiliation': 'Center for Behavioral Intervention Technologies, Department of Medical Social Sciences and Psychiatry and Behavioral Sciences, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Wendy F', 'Initials': 'WF', 'LastName': 'Cohn', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.'}]",JMIR research protocols,['10.2196/11452'] 3421,31993719,"A randomized, open-label, controlled trial of monthly oral minodronate or semiannual subcutaneous injection of denosumab for bone loss by androgen deprivation in Asian men with prostate cancer: the PRevention of Osteopenia with Minodronate And DEnosumab (PROMADE) study.","There is still a lack of evidence that minodronate or denosumab prevents bone loss due to androgen deprivation therapy (ADT) in non-Western patients. This study showed that both drugs significantly improved lumbar spine and total hip bone mineral density in Asian men with prostate cancer who received ADT. INTRODUCTION To evaluate whether monthly oral minodronate or semiannual subcutaneous injection of denosumab improves bone mineral density (BMD) in Asian men with prostate cancer (PCa) receiving ADT. METHODS A multicenter, open-label, randomized, controlled study including patients with hormone-sensitive PCa without bone metastasis receiving ADT was performed. Patients were randomized (1:1:1) to minodronate, denosumab, or no agent control groups. The primary end point was the mean percentage change in BMD at the lumbar spine at 12 months. Secondary end points were the mean percentage change in BMD at the femoral neck and total hip and changes in bone turnover markers. Statistical comparison was performed using analysis of covariance. RESULTS Of the 147 subjects enrolled in this study, 102 were randomly assigned into the minodronate (n = 36), denosumab (n = 36), and control (n = 30) groups. The percentage change in BMD at the lumbar spine was significantly improved in the minodronate (2.5%, p < 0.05) and denosumab groups (4.0%, p < 0.01) compared with that in the control group (- 0.1%). Denosumab increased BMD at the femoral neck and total hip at 12 months, whereas minodronate only increased BMD at the total hip compared with controls (all p < 0.05). The percentage change in bone turnover markers at 12 months was significantly lower in the minodronate and denosumab groups compared with that in the control group (both p < 0.01). CONCLUSION Minodronate or denosumab can be used for preventing bone loss related to ADT in Asian patients with PCa.",2020,"The percentage change in bone turnover markers at 12 months was significantly lower in the minodronate and denosumab groups compared with that in the control group (both p < 0.01). ","['Asian men with prostate cancer (PCa) receiving ADT', 'Asian men with prostate cancer who received ADT', 'patients with hormone-sensitive PCa without bone metastasis receiving ADT was performed', 'Asian men with prostate cancer', '147 subjects enrolled in this study', 'Asian patients with PCa']","['Minodronate or denosumab', 'denosumab', 'minodronate, denosumab, or no agent control groups', 'Denosumab', 'oral minodronate or semiannual subcutaneous injection of denosumab']","['BMD', 'lumbar spine and total hip bone mineral density', 'BMD at the femoral neck and total hip', 'bone turnover markers', 'mean percentage change in BMD at the femoral neck and total hip and changes in bone turnover markers', 'bone mineral density (BMD', 'percentage change in BMD at the lumbar spine', 'mean percentage change in BMD at the lumbar spine']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0662880', 'cui_str': '(1-hydroxy-2-(imidazo(1,2-a)-pyridin-3-yl)ethylidene)bisphosphonic acid monohydrate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",102.0,0.0238162,"The percentage change in bone turnover markers at 12 months was significantly lower in the minodronate and denosumab groups compared with that in the control group (both p < 0.01). ","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology and Andrology, Kori Hospital, Kansai Medical University, 8-45 Kori Hondori cyo, Neyagawa, Osaka, 572-8551, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yanishi', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sugi', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, 2-3-1 Shin-machi, Hirakata, Osaka, 573-1191, Japan. matsudat@takii.kmu.ac.jp.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05271-5'] 3422,31994918,Examining the Relationships between Cumulative Childhood Adversity and the Risk of Criminal Justice Involvement and Victimization among Homeless Adults with Mental Illnesses after Receiving Housing First Intervention.,"OBJECTIVES Exposure to adverse childhood experiences (ACEs) is associated with increased risk of criminal justice involvement and repeated victimization among homeless individuals. This study aimed to (1) examine whether the relationship between cumulative ACE score and odds of experiencing criminal justice involvement and victimization remains significant over time after receiving the Housing First (HF) intervention and (2) investigate the moderating effect of cumulative ACE score on the effectiveness of the HF intervention on the likelihood of experiencing these outcomes among homeless individuals with mental illnesses. METHODS We used longitudinal data over the 2-year follow-up period from the At Home/ Chez Soi demonstration project that provided HF versus treatment as usual (TAU) to homeless adults with mental illness in five Canadian cities (N = 1,888). RESULTS In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors. However, cumulative ACE score did not moderate intervention effects on odds of experiencing either outcome, suggesting that the effectiveness of HF versus TAU, with regard to the odds of being victimized or criminal justice involvement, did not differ by cumulative ACE scores over the course of study. CONCLUSIONS Findings suggest that providing services for homeless individuals with mental illness should be trauma informed and include specialized treatment strategies targeting the experience of ACEs and trauma to improve their treatment outcomes. An intensive approach is required to directly address the problem of criminal justice involvement and victimization in these individuals.",2020,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","['homeless adults with mental illness in five Canadian cities (N = 1,888', 'homeless individuals with mental illnesses', 'Homeless Adults with Mental Illnesses after Receiving Housing First Intervention', 'homeless individuals', 'homeless individuals with mental illness']","['HF versus treatment as usual (TAU', 'Housing First (HF) intervention', 'HF intervention']","['cumulative ACE scores', 'cumulative ACE score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1888.0,0.0419138,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","[{'ForeName': 'Hanie', 'Initials': 'H', 'LastName': 'Edalati', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}, {'ForeName': 'Tonia L', 'Initials': 'TL', 'LastName': 'Nicholls', 'Affiliation': 'British Columbia Mental Health and Substance Use Services, Provincial Health Services Authority, Vancouver, Canada.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Schütz', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Faculty of Health Sciences, Somers Research Group, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': 'Institute of Urban Studies, University of Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': 'School of Psychology, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720902616'] 3423,31655965,A Robot-Based Play-Drama Intervention May Improve the Joint Attention and Functional Play Behaviors of Chinese-Speaking Preschoolers with Autism Spectrum Disorder: A Pilot Study.,Children with autism spectrum disorder (ASD) have deficits in joint attention and play behaviors. We examined whether a robot-based play-drama intervention would promote these skills. Chinese-speaking preschool children were randomly assigned to an intervention group (N = 12) and a waitlist control group (N = 11). Children in the intervention group watched three robot dramas and engaged in role-plays with both robots and human experimenters over the course of 9 weeks. There were significant improvements in joint attention initiations and functional play behaviors in the intervention group. Parents of this group of children also reported less severe social impairments. It was therefore concluded that a robot-based play-drama intervention can enhance the joint attention and play behaviors of children with ASD.,2020,Chinese-speaking preschool children were randomly assigned to an intervention group (N = 12) and a waitlist control group (N = 11).,"['children with ASD', 'Children with autism spectrum disorder (ASD', 'Chinese-speaking preschool children', 'Chinese-Speaking Preschoolers with Autism']","['Robot-Based Play-Drama Intervention', 'robot-based play-drama intervention', 'robot dramas and engaged in role-plays with both robots and human experimenters', 'waitlist control group']","['severe social impairments', 'joint attention and play behaviors', 'joint attention initiations and functional play behaviors', 'Joint Attention and Functional Play Behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0699820', 'cui_str': 'Role playing (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518192', 'cui_str': 'Play participation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0416125,Chinese-speaking preschool children were randomly assigned to an intervention group (N = 12) and a waitlist control group (N = 11).,"[{'ForeName': 'Wing-Chee', 'Initials': 'WC', 'LastName': 'So', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.. wingchee@cuhk.edu.hk.'}, {'ForeName': 'Chun-Ho', 'Initials': 'CH', 'LastName': 'Cheng', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}, {'ForeName': 'Wan-Yi', 'Initials': 'WY', 'LastName': 'Lam', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}, {'ForeName': 'Ka-Ching', 'Initials': 'KC', 'LastName': 'Ng', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}, {'ForeName': 'Hiu-Ching', 'Initials': 'HC', 'LastName': 'Tung', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Wong', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong S.A.R.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04270-z'] 3424,31345710,"Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study.","BACKGROUND The emergence and spread of resistance in Plasmodium falciparum malaria to artemisinin combination therapies in the Greater Mekong subregion poses a major threat to malaria control and elimination. The current study is part of a multi-country, open-label, randomised clinical trial (TRACII, 2015-18) evaluating the efficacy, safety, and tolerability of triple artemisinin combination therapies. A very high rate of treatment failure after treatment with dihydroartemisinin-piperaquine was observed in Thailand, Cambodia, and Vietnam. The immediate public health importance of our findings prompted us to report the efficacy data on dihydroartemisinin-piperaquine and its determinants ahead of the results of the overall trial, which will be published later this year. METHODS Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam were randomly assigned to receive dihydroartemisinin-piperaquine with or without mefloquine, as part of the TRACII trial. The primary outcome was the PCR-corrected efficacy at day 42. Next-generation sequencing was used to assess the prevalence of molecular markers associated with artemisinin resistance (kelch13 mutations, in particular Cys580Tyr) and piperaquine resistance (plasmepsin-2 and plasmepsin-3 amplifications and crt mutations). This study is registered with ClinicalTrials.gov, number NCT02453308. FINDINGS Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received dihydroartemisinin-piperaquine. The overall Kaplan-Meier estimate of PCR-corrected efficacy of dihydroartemisinin-piperaquine at day 42 was 50·0% (95% CI 41·1-58·3). PCR-corrected efficacies for individual sites were 12·7% (2·2-33·0) in northeastern Thailand, 38·2% (15·9-60·5) in western Cambodia, 73·4% (57·0-84·3) in Ratanakiri (northeastern Cambodia), and 47·1% (33·5-59·6) in Binh Phuoc (southwestern Vietnam). Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe). Compared with the results of our previous TRACI trial in 2011-13, the prevalence of molecular markers of artemisinin resistance (kelch13 Cys580Tyr mutations) and piperaquine resistance (plasmepsin2/3 amplifications and crt mutations) has increased substantially in the Greater Mekong subregion in the past decade. INTERPRETATION Dihydroartemisinin-piperaquine is not treating malaria effectively across the eastern Greater Mekong subregion. A highly drug-resistant P falciparum co-lineage is evolving, acquiring new resistance mechanisms, and spreading. Accelerated elimination of P falciparum malaria in this region is needed urgently, to prevent further spread and avoid a potential global health emergency. FUNDING UK Department for International Development, Wellcome Trust, Bill & Melinda Gates Foundation, Medical Research Council, and National Institutes of Health.",2019,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","['Patients aged between 2 and 65 years presenting with uncomplicated P falciparum or mixed species malaria at seven sites in Thailand, Cambodia, and Vietnam', 'Between Sept 28, 2015, and Jan 18, 2018, 539 patients with acute P falciparum malaria were screened for eligibility, 292 were enrolled, and 140 received', 'Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam']","['dihydroartemisinin-piperaquine with or without mefloquine', 'dihydroartemisinin-piperaquine']","['plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe', 'efficacy, safety, and tolerability', 'PCR-corrected efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006797', 'cui_str': 'Khmer Republic'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",539.0,0.149168,"Treatment failure was associated independently with plasmepsin2/3 amplification status and four mutations in the crt gene (Thr93Ser, His97Tyr, Phe145Ile, and Ile218Phe).","[{'ForeName': 'Rob W', 'Initials': 'RW', 'LastName': 'van der Pluijm', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nguyen Hoang', 'Initials': 'NH', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu Thi', 'Initials': 'NT', 'LastName': 'Hoa', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thanh', 'Initials': 'NT', 'LastName': 'Thuy-Nhien', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngo Viet', 'Initials': 'NV', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Podjanee', 'Initials': 'P', 'LastName': 'Jittamala', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Borimas', 'Initials': 'B', 'LastName': 'Hanboonkunupakarn', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kitipumi', 'Initials': 'K', 'LastName': 'Chutasmit', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Chalermpon', 'Initials': 'C', 'LastName': 'Saelow', 'Affiliation': 'Phu Sing Hospital, Phu Sing, Thailand.'}, {'ForeName': 'Ratchadaporn', 'Initials': 'R', 'LastName': 'Runjarern', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Weerayuth', 'Initials': 'W', 'LastName': 'Kaewmok', 'Affiliation': 'Khun Han Hospital, Khun Han, Thailand.'}, {'ForeName': 'Rupam', 'Initials': 'R', 'LastName': 'Tripura', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Peto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sovann', 'Initials': 'S', 'LastName': 'Yok', 'Affiliation': 'Pailin Provincial Health Department, Pailin, Cambodia.'}, {'ForeName': 'Seila', 'Initials': 'S', 'LastName': 'Suon', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sokunthea', 'Initials': 'S', 'LastName': 'Sreng', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Sivanna', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Sampov Meas Referral Hospital, Pursat, Cambodia.'}, {'ForeName': 'Savuth', 'Initials': 'S', 'LastName': 'Oun', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Sovannary', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Ratanakiri Referral Hospital, Ratanakiri, Cambodia.'}, {'ForeName': 'Chanaki', 'Initials': 'C', 'LastName': 'Amaratunga', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Dysoley', 'Initials': 'D', 'LastName': 'Lek', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia; School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Rekol', 'Initials': 'R', 'LastName': 'Huy', 'Affiliation': 'National Center for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Dhorda', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; WorldWide Antimalarial Resistance Network Asia Regional Centre, Bangkok, Thailand.'}, {'ForeName': 'Kesinee', 'Initials': 'K', 'LastName': 'Chotivanich', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ashley', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit, Vientiane, Laos.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Waithira', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Phaik Yeong', 'Initials': 'PY', 'LastName': 'Cheah', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Maude', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Harvard T H Chan School of Public Health, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Amato', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Pearson', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sónia', 'Initials': 'S', 'LastName': 'Gonçalves', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Jacob', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Hamilton', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom.'}, {'ForeName': 'Rick M', 'Initials': 'RM', 'LastName': 'Fairhurst', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winterberg', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': 'Kwiatkowski', 'Affiliation': 'Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sasithon', 'Initials': 'S', 'LastName': 'Pukrittayakamee', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; The Royal Society of Thailand, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Tran Tinh', 'Initials': 'TT', 'LastName': 'Hien', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nicholas Pj', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Olivo', 'Initials': 'O', 'LastName': 'Miotto', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Wellcome Sanger Institute, Hinxton, United Kingdom; MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Arjen M', 'Initials': 'AM', 'LastName': 'Dondorp', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: arjen@tropmedres.ac.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30391-3'] 3425,31989065,Dissecting the Contemporary Clerkship: Theory-based Educational Trial of Videos Versus Lectures in Medical Student Education.,"Background Despite increasing use of the flipped classroom (FC) technique in undergraduate medical education, the benefit in learning outcomes over lectures is inconsistent. Best practices in preclass video design principles are rarely used, and it is unclear if videos can replace lectures in contemporary medical education. Methods We conducted a prospective quasi-experimental controlled educational study comparing theory-based videos to traditional lectures in a medical student curriculum. Medical students enrolled in an emergency medicine clerkship were randomly assigned to either a lecture group (LG) or a video group (VG). The slide content was identical, and the videos aligned with cognitive load theory-based multimedia design principles. Students underwent baseline (pretest), week 1 (posttest), and end-of-rotation (retention) written knowledge tests and an observed structured clinical examination (OSCE) assessment. We compared scores between both groups and surveyed student attitudes and satisfaction with respect to the two learning methods. Results There were 104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG). The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG). All three knowledge test scores for both groups were not significantly different. Conclusions Videos based on cognitive load theory produced similar results and could replace traditional lectures for medical students. Educators contemplating a FC approach should devote their valuable classroom time to active learning methods.",2020,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","['104 students who participated in OSCE assessments (49 LG, 55 VG) and 101 students who participated in knowledge tests (48 LG, 53 VG', 'Medical students enrolled in an emergency medicine clerkship']","['flipped classroom (FC) technique', 'Contemporary Clerkship', 'lecture group (LG) or a video group (VG', 'theory-based videos to traditional lectures']",['OSCE scores'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}]","[{'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",104.0,0.0319496,"The difference in OSCE scores was statistically significant 1.29 (95% confidence interval = 0.23 to 2.35, t(102) = 2.43, p = 0.017), but the actual score difference was small from an educational standpoint (12.61 for LG, 11.32 for VG).","[{'ForeName': 'Stella H M', 'Initials': 'SHM', 'LastName': 'Yiu', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Alena M', 'Initials': 'AM', 'LastName': 'Spacek', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Pageau', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'Michael Y C', 'Initials': 'MYC', 'LastName': 'Woo', 'Affiliation': 'Department of Emergency Medicine The Ottawa Hospital University of Ottawa Ontario Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curtis Lee', 'Affiliation': 'University of Newcastle Callaghan New South Wales Australia.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Frank', 'Affiliation': 'Royal College of Physicians and Surgeons of Canada Ottawa Ontario Canada.'}]",AEM education and training,['10.1002/aet2.10370'] 3426,552570,Evaluation of counselling in a general practice setting: preliminary communication.,,1979,,[],[],[],[],[],[],,0.0250396,,"[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Ashurst', 'Affiliation': ''}]",Journal of the Royal Society of Medicine,[] 3427,31994365,Long-term effect of oxycodone/naloxone on the management of postoperative pain after hysterectomy: a randomized prospective study.,"BACKGROUND The analgesic efficacy of oxycodone prolonged-release (PR) combined with naloxone PR (OXN) in postoperative pain management is recognized, however, few studies have examined the efficacy of OXN on pain relief and bowel function following hysterectomy. This study compared the effect of OXN vs. standard treatment for post-operative pain management and bowel function following hysterectomy. METHODS This randomized prospective study included 83 women who underwent laparoscopic/laparotomic hysterectomy. General anesthesia was induced by propofol (1.5-2 mg/kg), fentanyl (50-100 μg) and rocuronium (0.6-1 mg/kg) and maintained with sevoflurane (MAC 0.8-1) and fentanyl (1-2 μg/kg). Intraoperative analgesia was performed with ketorolac (30 mg), paracetamol (1 g) and morphine (0.1 mg/kg). Postoperative analgesia in the control group (N.=41) included morphine (0.2-0.4 mg/kg/day), whereas the OXN (N.=42) group only received oxycodone (10 mg)/naloxone (5 mg) for the first 48 hours. As rescue analgesic, both groups received paracetamol (3 mg). Bowel Function Index (BFI) and pain numeric rating scales (NRS) were measured at day 0, 1, 2, 3, 5 and 7, whereas vital parameters, rescue medication and side effects were recorded for the first three days only. RESULTS Bowel function indices were significantly improved in OXN-treated patients at all time points compared to morphine-treated patients. Mean static pain NRS was significantly decreased at day 2 and day 3 and dynamic pain NRS at day 3 in the OXN group. Side effects, rescue analgesic and antiemetics were more frequent in the control group. CONCLUSIONS Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.",2020,"Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.","['83 women who underwent', 'post-operative pain after hysterectomy']","['morphine', 'laparoscopic/laparotomic hysterectomy', 'sevoflurane (MAC 0.8-1) and fentanyl', 'OXN', 'paracetamol', 'propofol', 'ketorolac', 'fentanyl', 'oxycodone/naloxone', 'oxycodone prolonged-release (PR) combined with naloxone PR (OXN', 'oxycodone (10mg)/naloxone', 'rocuronium']","['Side effects, rescue analgesic and antiemetics', 'Mean static pain NRS', 'vital parameters, rescue medication and side effects', 'pain relief and bowel function', 'Bowel function indices', 'Improved pain control, bowel function and reduced side effects', 'Bowel function index (BFI) and pain numeric rating scales (NRS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0222045'}]",83.0,0.0750278,"Improved pain control, bowel function and reduced side effects were observed with OXN compared to morphine in patients who underwent hysterectomy.","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Iorno', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy - vittorio.iorno@fastwebnet.it.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Landi', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}, {'ForeName': 'Giuliana A', 'Initials': 'GA', 'LastName': 'Porro', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}, {'ForeName': 'Colin G', 'Initials': 'CG', 'LastName': 'Egan', 'Affiliation': 'CE-Medical Writing, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Calderini', 'Affiliation': ""Mario Tiengo Center of Pain Medicine, Maggiore Polyclinic Hospital, IRCCS Ca' Granda Foundation, Milan, Italy.""}]",Minerva anestesiologica,['10.23736/S0375-9393.20.13745-3'] 3428,31997369,Patients' interpersonal problems as moderators of depression outcomes in a randomized controlled trial comparing mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy in chronic depression.,"OBJECTIVES Interpersonal problems were examined as moderators of depression outcomes between mindfulness-based cognitive therapy (MBCT) and cognitive behavioral analysis system of psychotherapy (CBASP) in patients with chronic depression. METHODS Patients received treatment-as-usual and, in addition, were randomized to 8-weeks of MBCT (n = 34) or 8-weeks of CBASP (n = 34). MBCT and CBASP were given in a group format. The Hamilton depression rating scale (HAM-D) was the primary and the Beck Depression Inventory (BDI-II) the secondary outcome. The subscales of the Inventory of interpersonal problems (IIP-32) were moderators. Multilevel models were performed. RESULTS Higher scores on the ""vindictive/self-centered"" subscale were associated with a better outcome in MBCT than in CBASP (HAM-D: p < .01; BDI-II: p < .01). Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). CONCLUSIONS If these results can be replicated in larger trials, MBCT should be preferred to CBASP in chronically depressed patients being vindictive/self-centered, whereas CBASP should be preferred to MBCT in chronically depressed patients being nonassertive.",2020,"Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). ","['Patients received treatment-as-usual and, in addition', 'chronic depression', 'patients with chronic depression']","['CBASP', 'mindfulness-based cognitive therapy (MBCT) and cognitive behavioral analysis system of psychotherapy (CBASP', 'MBCT and CBASP', 'mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy', 'MBCT']","['nonassertive"" subscale', 'vindictive/self-centered"" subscale', 'Hamilton depression rating scale (HAM-D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression (disorder)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]",,0.0194586,"Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems an der Donau, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Faculty Social Work, Health, and Nursing, Esslingen University of Applied Sciences, Esslingen am Neckar, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}]",Journal of clinical psychology,['10.1002/jclp.22931'] 3429,31842688,End-of-Treatment Intracerebral and Ventricular Hemorrhage Volume Predicts Outcome: A Secondary Analysis of MISTIE III.,"Background and Purpose- Trials have shown potential clinical benefit for minimally invasive clot evacuation of intracerebral hemorrhage (ICH). Prior research showing an association between ICH size and functional outcome did not fully address the spectrum of hematoma volumes seen after clot evacuation. Methods- In this secondary analysis of the MISTIE III trial (Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation III), we included patients randomized to the surgical arm. The primary outcome was good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment). The primary predictors were the end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score. Results- In 246 patients, the end-of-treatment computed tomography was performed an average of 5 days from onset. For patients with good versus poor outcomes, the mean end-of-treatment ICH and intraventricular hemorrhage volumes were 12.9 versus 18.0 mL ( P =0.002) and 0.5 versus 2.3 mL ( P <0.001), respectively. The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0 (>20 mL; P =0.001). Conclusions- After surgical clot evacuation, both ICH and intraventricular hemorrhage volumes have a strong association with good neurological outcome. The EoT ICH volume score needs independent verification, but such an approach could be used for prognostication and therapeutic planning.",2020,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,['Intracerebral Hemorrhage Evacuation III'],"['Methods', ' and Purpose']","['good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment', 'mean end-of-treatment ICH and intraventricular hemorrhage volumes', 'end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",246.0,0.0819232,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Joyce', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'the Department of Neurology, New York University (S.Y.).'}, {'ForeName': 'Safdar', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Delic', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Taussky', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Radiology (M.A.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tirschwell', 'Affiliation': 'the Department of Neurology, University of Washington, Seattle (D.T.).'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Grandhi', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}]",Stroke,['10.1161/STROKEAHA.119.028199'] 3430,31989232,Prospective Analysis and Comparison of Periareolar Excision (Delivery) Technique and Pull-Through Technique for the Treatment of Gynecomastia.,"BACKGROUND Gynecomastia is one of the most common disorders affecting adolescent and adult males. It is a benign disorder but has severe psychological manifestations like low self-confidence, depression, anxiety and social phobia in patients suffering from gynecomastia. Different surgical techniques have been described utilizing a variety of incisions, excisions, lipectomy and liposuction methods. Very frequently, these methods are combined for the gynecomastia treatment with variable reported results. However, there is a lack of studies comparing these techniques. The present study was planned to compare cases of gynecomastia treated by liposuction with periareolar excision (delivery technique) and liposuction with a pull-through technique. METHOD A prospective randomized control study was conducted at a tertiary care hospital on 20 patients with gynecomastia. The patients were assigned to either liposuction with periareolar excision (delivery technique) or liposuction with pull-through technique. Anthropometric analysis and breast evaluation questionnaire (BEQ) scores were analyzed and compared before and after the surgery. RESULTS The majority of the study subjects were between 21 and 30 years of age. Low self-confidence was the main reason for surgery in most of the cases. Twelve patients had gynecomastia grade IIa and eight had grade IIb. Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference. A statistically insignificant difference was observed between the groups on comparison of anthropometric analysis preoperatively and postoperatively. The mean lipoaspirate volume was 280 ml for the pull-through technique and 367 ml for the periareolar excision technique. No complications were observed in cases operated on by the pull-through technique, while two cases (10%) operated on by the periareolar excision had hematomas. CONCLUSION Both techniques provide excellent cosmetic results with low risk of complications in both small and moderate breast enlargement with skin excess. The pull-through technique combines the benefits of direct excision of glandular tissues along with the minimally invasive nature of liposuction. Thus, performing the procedure via a single incision without the use of drains is a safer alternative to traditional liposuction with the periareolar excision technique. LEVEL OF EVIDENCE III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference.,"['patients suffering from gynecomastia', 'study subjects were between 21 and 30\xa0years of age', '20 patients with gynecomastia', 'Twelve patients had gynecomastia grade IIa and eight had grade IIb']","['liposuction with periareolar excision (delivery technique) or liposuction with pull-through technique', 'Periareolar Excision', 'liposuction with periareolar excision (delivery technique) and liposuction with a pull-through technique']","['hematomas', 'mean lipoaspirate volume', 'Anthropometric analysis and breast evaluation questionnaire (BEQ) scores', 'BEQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0457447', 'cui_str': 'Pull-through technique (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0378695,Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference.,"[{'ForeName': 'Satyaswarup', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Likhyani', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. dr.sharma.raman@gmail.com.'}, {'ForeName': 'Ramesh Kumar', 'Initials': 'RK', 'LastName': 'Sharma', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01618-0'] 3431,31986239,"Evaluating body composition in infancy and childhood: A comparison between 4C, QMR, DXA, and ADP.","BACKGROUND Accurate and precise methods to measure of body composition in infancy and childhood are needed. OBJECTIVES This study evaluated differences and precision of three methods when compared with the four-compartment (4C) model for estimating fat mass (FM). METHODS FM of children (age 14 days to 6 years of age, N = 346) was obtained using quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6 years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR). The 4C model was computed. Correlation, concordance, and Bland-Altman analyses were performed. RESULTS In infants, PeaPod had high individual FM accuracy, whereas DXA had high group FM accuracy compared with 4C. In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively). The instrument FM precision was best for QMR (10 g) followed by BodPod (34 g), PeaPod (38 g), and DXA (45 g). CONCLUSIONS In infants, PeaPod was the best method to estimate individual FM whereas DXA was best to estimate group FM. In children, DXA was best to estimate individual and group FM. QMR had the highest instrument precision.",2020,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","['infancy and childhood', 'FM of children (age 14\u2009days to 6\u2009years of age, N = 346']","['quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6\u2009years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR']","['individual FM accuracy', 'individual FM accuracies', 'FM accuracy']","[{'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0298047,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","[{'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Heard-Lipsmeyer', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Sims', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}]",Pediatric obesity,['10.1111/ijpo.12617'] 3432,31990350,Neonatal BCG Vaccination Reduces Interferon-γ Responsiveness to Heterologous Pathogens in Infants From a Randomized Controlled Trial.,"BACKGROUND BCG vaccination has beneficial nonspecific (heterologous) effects that protect against nonmycobacterial infections. We have previously reported that BCG vaccination at birth alters in vitro cytokine responses to heterologous stimulants in the neonatal period. This study investigated heterologous responses in 167 infants in the same trial 7 months after randomization. METHODS A whole-blood assay was used to interrogate in vitro cytokine responses to heterologous stimulants (killed pathogens) and Toll-like receptor (TLR) ligands. RESULTS Compared to BCG-naive infants, BCG-vaccinated infants had increased production of interferon gamma (IFN-γ) and monokine induced by gamma interferon (MIG) (CXCL9) in response to mycobacterial stimulation and decreased production of IFN-γ in response to heterologous stimulation and TLR ligands. Reduced IFN-γ responses were attributable to a decrease in the proportion of infants who mounted a detectable IFN-γ response. BCG-vaccinated infants also had increased production of MIG (CXCL9) and interleukin-8 (IL-8), and decreased production of IL-10, macrophage inflammatory protein-1α (MIP-1α), and MIP-1β, the pattern of which varied by stimulant. IL-1Ra responses following TLR1/2 (Pam3CYSK4) stimulation were increased in BCG-vaccinated infants. Both sex and maternal BCG vaccination status influenced the effect of neonatal BCG vaccination. CONCLUSIONS BCG vaccination leads to changes in IFN-γ responsiveness to heterologous stimulation. BCG-induced changes in other cytokine responses to heterologous stimulation vary by pathogen.",2020,"BCG-vaccinated infants also had increased production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß, the pattern of which varied by stimulant.",['167 infants in the same trial seven months after randomisation'],"['Neonatal BCG vaccination', 'Bacille Calmette-Guérin (BCG) vaccination', 'heterologous stimulants (killed pathogens) and Toll-like receptor (TLR) ligands']","['IL-1Ra responses following TLR1/2 (Pam3CYSK4) stimulation', 'IFN-γ responses', 'production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß', 'production of MIG and IFN-γ', 'IFN-γ responsiveness']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0670896'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.105443,"BCG-vaccinated infants also had increased production of MIG and IL-8, and decreased production of IL-10, MIP-1α and MIP-1ß, the pattern of which varied by stimulant.","[{'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Freyne', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': 'Department of Paediatrics, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Germano', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Bonnici', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Kaya', 'Initials': 'K', 'LastName': 'Gardiner', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Casalaz', 'Affiliation': 'Department of Paediatrics, Mercy Hospital for Women, Heidelberg, Australia.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Robins-Browne', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Flanagan', 'Affiliation': 'University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Kollmann', 'Affiliation': 'Department of Experimental Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Infectious Diseases and Microbiology Group, Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Parkville, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jiaa030'] 3433,32005561,Efficacy of Repeat Selective Laser Trabeculoplasty in Medication-Naive Open-Angle Glaucoma and Ocular Hypertension during the LiGHT Trial.,"PURPOSE To determine the efficacy of repeat selective laser trabeculoplasty (SLT) in medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. DESIGN Post hoc analysis of SLT treatment arm of a multicenter prospective randomized controlled trial. PARTICIPANTS Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months. Retreatment was triggered by predefined IOP and disease-progression criteria (using objective individualized target IOPs). METHODS After SLT at baseline, patients were followed for a minimum of 18 months after second (repeat) SLT. A mixed-model analysis was performed with the eye as the unit of analysis, with crossed random effects to adjust for correlation between fellow eyes and repeated measures within eyes. Kaplan-Meier curves plot the duration of effect. MAIN OUTCOME MEASURES Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT. RESULTS A total of 115 eyes of 90 patients received repeat SLT during the first 18 months of the trial. Pretreatment IOP before initial SLT was significantly higher than before retreatment IOP of repeat SLT (mean difference, 3.4 mmHg; 95% confidence interval [CI], 2.6-4.3 mmHg; P < 0.001). Absolute IOP reduction at 2 months was greater after initial SLT compared with repeat SLT (mean difference, 1.0 mmHg; 95% CI, 0.2-1.8 mmHg; P = 0.02). Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001). A total of 34 eyes were early failures (retreatment 2 months after initial SLT) versus 81 later failures (retreatment >2 months after initial SLT). No significant difference in early absolute IOP reduction at 2 months after repeat SLT was noted between early and later failures (mean difference, 0.3 mmHg; 95% CI, -1.1 to 1.8 mmHg; P = 0.655). Repeat SLT maintained drop-free IOP control in 67% of 115 eyes at 18 months, with no clinically relevant adverse events. CONCLUSIONS These exploratory analyses demonstrate that repeat SLT can maintain IOP at or below target IOP in medication-naive OAG and OHT eyes requiring retreatment with at least an equivalent duration of effect to initial laser.",2020,"Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001).","['Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months', 'A total of 115 eyes of 90 patients received', 'medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial']","['Repeat Selective Laser Trabeculoplasty', 'repeat selective laser trabeculoplasty (SLT', 'repeat SLT']","['early absolute IOP reduction', 'Adjusted absolute IOP reduction', 'Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT', 'Repeat SLT maintained drop-free IOP control', 'Absolute IOP reduction']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",34.0,0.108816,"Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001).","[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Vickerstaff', 'Affiliation': 'Marie Curie Palliative Care Research Department, UCL Division of Psychiatry, University College London, London, United Kingdom; The Research Department of Primary Care and Population Health, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Department of Statistical Science, University College London, London, United Kingdom.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom; London School of Hygiene and Tropical Medicine, London, United Kingdom.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wormald', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: gusgazzard@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.10.023'] 3434,31343402,Low-dose oral theophylline combined with inhaled corticosteroids for people with chronic obstructive pulmonary disease and high risk of exacerbations: a RCT.,"BACKGROUND Despite widespread use of therapies such as inhaled corticosteroids (ICSs), people with chronic obstructive pulmonary disease (COPD) continue to suffer, have reduced life expectancy and utilise considerable NHS resources. Laboratory investigations have demonstrated that at low plasma concentrations (1-5 mg/l) theophylline markedly enhances the anti-inflammatory effects of corticosteroids in COPD. OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of adding low-dose theophylline to a drug regimen containing ICSs in people with COPD at high risk of exacerbation. DESIGN A multicentre, pragmatic, double-blind, randomised, placebo-controlled clinical trial. SETTING The trial was conducted in 121 UK primary and secondary care sites. PARTICIPANTS People with COPD [i.e. who have a forced expiratory volume in 1 second (FEV 1 )/forced vital capacity (FVC) of < 0.7] currently on a drug regimen including ICSs with a history of two or more exacerbations treated with antibiotics and/or oral corticosteroids (OCSs) in the previous year. INTERVENTIONS Participants were randomised (1 : 1) to receive either low-dose theophylline or placebo for 1 year. The dose of theophylline (200 mg once or twice a day) was determined by ideal body weight and smoking status. PRIMARY OUTCOME The number of participant-reported exacerbations in the 1-year treatment period that were treated with antibiotics and/or OCSs. RESULTS A total of 1578 people were randomised (60% from primary care): 791 to theophylline and 787 to placebo. There were 11 post-randomisation exclusions. Trial medication was prescribed to 1567 participants: 788 in the theophylline arm and 779 in the placebo arm. Participants in the trial arms were well balanced in terms of characteristics. The mean age was 68.4 [standard deviation (SD) 8.4] years, 54% were male, 32% smoked and mean FEV 1 was 51.7% (SD 20.0%) predicted. Primary outcome data were available for 98% of participants: 772 in the theophylline arm and 764 in the placebo arm. There were 1489 person-years of follow-up data. The mean number of exacerbations was 2.24 (SD 1.99) for participants allocated to theophylline and 2.23 (SD 1.97) for participants allocated to placebo [adjusted incidence rate ratio (IRR) 0.99, 95% confidence interval (CI) 0.91 to 1.08]. Low-dose theophylline had no significant effects on lung function (i.e. FEV 1 ), incidence of pneumonia, mortality, breathlessness or measures of quality of life or disease impact. Hospital admissions due to COPD exacerbation were less frequent with low-dose theophylline (adjusted IRR 0.72, 95% CI 0.55 to 0.94). However, 39 of the 51 excess hospital admissions in the placebo group were accounted for by 10 participants having three or more exacerbations. There were no differences in the reporting of theophylline side effects between the theophylline and placebo arms. LIMITATIONS A higher than expected percentage of participants (26%) ceased trial medication; this was balanced between the theophylline and placebo arms and mitigated by over-recruitment ( n  = 154 additional participants were recruited) and the high rate of follow-up. The limitation of not using documented exacerbations is addressed by evidence that patient recall is highly reliable and the results of a small within-trial validation study. CONCLUSION For people with COPD at high risk of exacerbation, the addition of low-dose oral theophylline to a drug regimen that includes ICSs confers no overall clinical or health economic benefit. This result was evident from the intention-to-treat and per-protocol analyses. FUTURE WORK To promote consideration of the findings of this trial in national and international COPD guidelines. TRIAL REGISTRATION Current Controlled Trials ISRCTN27066620. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 37. See the NIHR Journals Library website for further project information.",2019,"Low-dose theophylline had no significant effects on lung function (i.e. FEV 1 ), incidence of pneumonia, mortality, breathlessness or measures of quality of life or disease impact.","['The mean age was 68.4 [standard deviation (SD) 8.4] years, 54% were male, 32% smoked and mean', 'people with chronic obstructive pulmonary disease (COPD', 'people with chronic obstructive pulmonary disease and high risk of exacerbations', '1567 participants: 788 in the theophylline arm and 779 in the placebo arm', 'arm and 764 in the placebo arm', 'A total of 1578 people were randomised (60% from primary care', '1489 person-years of follow-up data', 'people with COPD at high risk of exacerbation', '121 UK primary and secondary care sites', 'People with COPD [i.e. who have a forced expiratory volume in 1 second (FEV 1 )/forced vital capacity (FVC) of <\u20090.7] currently on a drug regimen including ICSs with a history of two or more exacerbations treated with antibiotics']","['low-dose theophylline', 'theophylline', 'placebo', 'oral corticosteroids (OCSs', 'theophylline and placebo', 'theophylline combined with inhaled corticosteroids', 'low-dose theophylline or placebo']","['incidence rate ratio', 'hospital admissions', 'theophylline side effects', 'mean number of exacerbations', 'lung function (i.e. FEV 1 ), incidence of pneumonia, mortality, breathlessness or measures of quality of life or disease impact', 'clinical effectiveness and cost-effectiveness', 'number of participant-reported exacerbations', 'Hospital admissions due to COPD exacerbation']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]",1567.0,0.740055,"Low-dose theophylline had no significant effects on lung function (i.e. FEV 1 ), incidence of pneumonia, mortality, breathlessness or measures of quality of life or disease impact.","[{'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Devereux', 'Affiliation': 'Respiratory Medicine, Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Seonaidh', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Fielding', 'Affiliation': 'Medical Statistics Team, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Barnes', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Burns', 'Affiliation': 'Department of Respiratory Medicine, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Chaudhuri', 'Affiliation': 'Gartnavel General Hospital, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Chrystyn', 'Affiliation': 'Inhalation Consultancy Ltd, Leeds, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Aintree Chest Centre, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Anthony De', 'Initials': 'A', 'LastName': 'Soyza', 'Affiliation': 'Medical School, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gompertz', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haughney', 'Affiliation': 'Gartnavel General Hospital, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Innes', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Kaniewska', 'Affiliation': 'Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Medical Statistics Team, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Alyn', 'Initials': 'A', 'LastName': 'Morice', 'Affiliation': 'Cardiovascular and Respiratory Studies, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sullivan', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Respiratory Medicine, Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23370'] 3435,31813354,Brain Natriuretic Peptide and Discovery of Atrial Fibrillation After Stroke: A Subanalysis of the Find-AF RANDOMISED Trial.,"Background and Purpose- Diagnosing paroxysmal atrial fibrillation (pAF) can be challenging after acute ischemic stroke. Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients. We hypothesized that brain natriuretic peptide (BNP) may help to identify patients with stroke at high risk for pAF to select patients for EPM more effectively. Methods- Patients with acute cerebral ischemia ≥60 years presenting in sinus rhythm and without history of AF were included into a prospective, randomized multicenter study to receive either EPM (3× 10-day Holter-ECG) or usual stroke care diagnostic work-up. BNP plasma levels were measured on randomization and 3 months thereafter. Levels were compared between patients with and without pAF detected by means of EPM or usual care. Furthermore, the number needed to screen for EPM depending on BNP cut offs was calculated. Results- A total of 398 patients were analyzed. In 373 patients (93.7%), BNP was measured at baseline and in 275 patients (69.1%) after 3 months. pAF was found in 27 patients by means of EPM and in 9 patients by means of usual care ( P =0.002). Median BNP was higher in patients with pAF as compared to patients without AF in both study arms at baseline (57.8 versus 28.3 pg/mL in the EPM arm, P =0.0003; 46.2 versus 27.7 pg/mL, P =0.28 in the control arm) and after 3 months (74.9 versus 31.3 pg/mL, P =0.012 in the EPM arm, 99.3 versus 26.3 pg/mL, P =0.02 in the control arm). Applying a cut off of 100 pg/mL, the number needed to screen was reduced from 18 by usual care to 3 by EPM. Conclusions- BNP measured early after ischemic stroke identifies a subgroup of patients with stroke at increased risk for AF, in whom EPM is particularly efficacious. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01855035.",2020,Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients.,"['A total of 398 patients were analyzed', 'Methods- Patients with acute cerebral ischemia ≥60 years presenting in sinus rhythm and without history of AF']","['Conclusions- BNP', 'pAF', 'EPM (3× 10-day Holter-ECG) or usual stroke care diagnostic work-up', 'prolonged Holter-ECG monitoring (EPM', 'brain natriuretic peptide (BNP', ' and Purpose']","['detection rate', 'BNP', 'BNP plasma levels', 'Brain Natriuretic Peptide and Discovery of Atrial Fibrillation', 'Median BNP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",398.0,0.147919,Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients.,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wasser', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weber-Krüger', 'Affiliation': 'Clinic for Cardiology and Pneumology (M.W.-K., R.W.), University of Göttingen, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gröschel', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Uphaus', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liman', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Clinic for Neurology and Neurorehabilitation, Bezirkskrankenhaus Günzburg, Germany (G.F.H.).'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kermer', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seegers', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, University Hospital Regensburg, Germany (J.S.).'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Binder', 'Affiliation': 'Institute for Clinical Chemistry (L.B.), University of Göttingen, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute for Clinical Epidemiology and Biometry, University of Würzburg, Germany (G.G.).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic for Cardiology and Pneumology (M.W.-K., R.W.), University of Göttingen, Germany.'}]",Stroke,['10.1161/STROKEAHA.119.026496'] 3436,31803945,A Randomized Controlled Trial of an Integrated Alcohol Reduction Intervention in Patients With Hepatitis C Infection.,"BACKGROUND AND AIMS Hepatitis C virus (HCV) and alcohol use are patient risk factors for accelerated fibrosis progression, yet few randomized controlled trials have tested clinic-based alcohol interventions. APPROACH AND RESULTS A total of 181 patients with HCV and qualifying alcohol screener scores at three liver center settings were randomly assigned to the following: (1) medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or (2) SBIRT plus 6 months of integrated colocated alcohol therapy (SBIRT + Alcohol Treatment). The timeline followback method was used to assess alcohol use at baseline and 3, 6, and 12 months. Coprimary outcomes were alcohol abstinence at 6 months and heavy drinking days between 6 and 12 months. Secondary outcomes included grams of alcohol consumed per week at 6 months. Mean therapy hours across 6 months were 8.8 for SBIRT-only and 10.1 for SBIRT + Alcohol Treatment participants. The proportion of participants exhibiting full alcohol abstinence increased from baseline to 3, 6, and 12 months in both treatment arms, but no significant differences were found between arms (baseline to 6 months, 7.1% to 20.5% for SBIRT-only; 4.2% to 23.3% for SBIRT + Alcohol Treatment; P = 0.70). Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT + Alcohol Treatment (85.7% to 42.1%) arms (P = 0.30). Although both arms reduced average grams of alcohol consumed per week from baseline to 6 and 12 months, between-treatment effects were not significant. CONCLUSIONS Patients with current or prior HCV infection will engage in alcohol treatment when encouraged by liver medical providers. Liver clinics should consider implementing provider-delivered SBIRT and tailored alcohol treatment referrals as part of the standard of care.",2020,Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT+Alcohol Treatment (85.7% to 42.1%) arms,"['181 patients with HCV and qualifying alcohol screener scores at three liver center settings', 'Conclusion: Patients with current or prior HCV-infection will engage in alcohol treatment when encouraged by liver medical providers', 'patients with hepatitis C infection']","['medical provider-delivered Screening, Brief Intervention, and Referral to Treatment (SBIRT), including motivational interviewing counseling and referral out for alcohol treatment (SBIRT-only), or 2) SBIRT plus six months of integrated co-located alcohol therapy (SBIRT+Alcohol Treatment', 'SBIRT+Alcohol', 'Hepatitis C (HCV) and alcohol', 'integrated alcohol reduction intervention']","['grams of alcohol consumed per week at 6 months', 'alcohol abstinence at 6 months and heavy drinking days', 'proportion of participants exhibiting full alcohol abstinence', 'average grams of alcohol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0678274', 'cui_str': 'Abstinences, Alcohol'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]",181.0,0.0378896,Proportions of participants with any heavy drinking days decreased in both groups at 6 months but did not significantly differ between the SBIRT-only (87.5% to 26.7%) and SBIRT+Alcohol Treatment (85.7% to 42.1%) arms,"[{'ForeName': 'Rae Jean', 'Initials': 'RJ', 'LastName': 'Proeschold-Bell', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, NC.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Evon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Makarushka', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Keefe', 'Affiliation': 'Duke Center for Health Policy & Inequalities Research, Duke University, Durham, NC.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duke University, Durham, NC.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mannelli', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duke University, Durham, NC.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Garbutt', 'Affiliation': 'Bowles Center for Alcohol Studies, School of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Wong', 'Affiliation': 'Division of Clinical Decision Making, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Julius M', 'Initials': 'JM', 'LastName': 'Wilder', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Santanu K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Hodge', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Naggie', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Fried', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, School of Medicine, Duke University, Durham, NC.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31058'] 3437,31718842,Spectral-Domain OCT-Based Prevalence and Progression of Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration.,"PURPOSE Previous studies of macular atrophy (MA) in HARBOR analyzed color fundus photography and fluorescein angiography image data. This study performed a longitudinal assessment of monthly spectral-domain (SD) OCT scans to determine MA prevalence, incidence, and progression in HARBOR. DESIGN Post hoc analysis of SD OCT images from HARBOR (ClincalTrials.gov identifier, NCT00891735), a phase 3 multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial. PARTICIPANTS Patients (n = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273). METHODS Evaluable SD OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined by masked reading center-trained graders monthly from baseline to month 24. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, retinal pigment epithelium loss, and loss of outer retinal layers. Macular atrophy was considered Definite if all 3 criteria were met and Questionable if 2 were met. Study arms were compared for time to MA detection (log-rank test) and enlargement rates (time × arm interaction test). MAIN OUTCOME MEASURES Prevalence, incidence, and enlargement rates of MA. RESULTS At baseline, imbalance in MA rates across ranibizumab arms was evident (0.5 mg monthly, 19.1%; 0.5 mg PRN, 16.1%; 2.0 mg monthly, 10.1%; 2.0 mg PRN, 10.5%). At month 24, new MA development rates in eyes without baseline MA were similar between ranibizumab doses (0.5 mg, 25.9%; 2.0 mg, 25.4%) and treatment regimens (monthly, 26.4%; PRN, 25.0%). No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms. CONCLUSIONS In this analysis of a major nAMD trial using CAM atrophy criteria, no differences were observed in incidence or progression rates of new MA among study arms, ranibizumab doses, or treatment regimens. Monthly versus PRN treatment did not influence MA incidence or progression.",2020,"No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms. ","['Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up', 'Patients (n\xa0= 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with']","['ranibizumab', 'monthly spectral-domain (SD) OCT scans', 'ranibizumab 0.5 mg monthly (n\xa0= 275), 0.5 mg pro re nata (PRN']","['Macular atrophy', 'enlargement rate of new atrophy area', 'MA incidence or progression', 'Prevalence, incidence, and enlargement rates of MA', 'new MA development rates', 'time to MA detection (log-rank test) and enlargement rates (time\xa0× arm interaction test', 'MA rates']","[{'cui': 'C0441633'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal (qualifier value)'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0441633'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0558288', 'cui_str': 'prn'}]","[{'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",1097.0,0.142077,"No significant differences in enlargement rate of new atrophy area (P = 0.479, square-root transformed) or time to detection of new MA (P = 0.997) were evident among study arms. ","[{'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Nizar Saleh', 'Initials': 'NS', 'LastName': 'Abdelfattah', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Karamat', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Marion', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.030'] 3438,32154095,Identifying patterns of physical activity and screen time parenting practices and associations with preschool children's physical activity and adiposity.,"Although physical activity and screen time parenting practices influence children's behaviors, little work has examined how these practices work in combination. The purpose of this study was to identify patterns of physical activity and screen time parenting practices, and examine differences in preschool children's physical activity, sedentary behavior, and adiposity among the identified patterns. Data were collected in 2009-2012 from 319 parent-child dyads enrolled in a randomized trial testing a parent-focused obesity prevention intervention. At baseline, physical activity and screen time parenting practices were assessed using a validated self-report survey. Children's physical activity and sedentary behavior were measured using accelerometers and child anthropometrics were objectively measured. Latent profile analyses identified patterns of physical activity and screen time parenting practices. Differences in child outcomes were tested among the identified classes. Three parent classes were identified: Rewarders ( n  = 165), Activity Supportive ( n  = 98), and Screen Time Permissive ( n  = 56). Rewarder parents were characterized by the highest scores on using physical activity and screen time to reward or control children's behavior. Activity Supportive parents generally had the highest scores on practices to promote physical activity, while Screen Time Permissive parents had the highest scores on practices facilitating screen time. There were no differences in the mean child physical activity, sedentary behavior or BMI z-score among the three classes. Findings revealed distinct classes of parents that could provide modifiable targets for family-based physical activity promotion, but more work is needed examining the influence of these patterns longitudinally and in different populations.",2020,Rewarder parents were characterized by the highest scores on using physical activity and screen time to reward or control children's behavior.,"['2009-2012 from 319 parent-child dyads enrolled', ""preschool children's""]",['parent-focused obesity prevention intervention'],"[""physical activity and screen time to reward or control children's behavior"", ""Children's physical activity and sedentary behavior"", 'mean child physical activity, sedentary behavior or BMI z-score', 'physical activity and screen time parenting practices', 'physical activity, sedentary behavior, and adiposity']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",,0.0195147,Rewarder parents were characterized by the highest scores on using physical activity and screen time to reward or control children's behavior.,"[{'ForeName': 'Cody D', 'Initials': 'CD', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Population Health Sciences, Duke University, Durham, NC, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mazzucca', 'Affiliation': 'Prevention Research Center in St. Louis, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101068'] 3439,31970830,Effects of hospital-family holistic care model on the health outcome of patients with permanent enterostomy based on the theory of 'Timing It Right'.,"AIMS AND OBJECTIVES To explore the effects of hospital-family holistic care model based on 'Timing It Right' on the health outcome of patients with permanent colostomy. BACKGROUND Colorectal cancer is a common malignant tumour of digestive system, which seriously threatens human life and health. Colostomy is one of the main treatments for colorectal cancer, which effectively improves the 5-year survival rate of patients. However, the postoperative psychological and physiological rehabilitation nursing is still faced with great challenges due to the change of body image and defecation pathway caused by colostomy. METHODS A randomised controlled trial was conducted, and 119 patients with permanent enterostomy were randomly divided into two groups, with 60 cases in the intervention group and 59 cases in the control group. The intervention group received routine care follow-up and hospital-family holistic care intervention based on 'Timing It Right', while the control group received routine care and follow-up. The resilience, self-care ability, complications and life quality of patients with permanent enterostomy were compared between two groups before intervention, at discharge, 3 months and 6 months after discharge. CONSORT checklist was applied as the reporting guideline for this study (see Appendix S1). RESULTS A total of 108 patients with permanent enterostomy completed the study (90.76%). At 3 months and 6 months after discharge, the resilience and quality of life in the intervention group were significantly better than those in the control group (t = 4.158 vs. 7.406, t = 4.933 vs. 8.611, p < .05), while the complications in the intervention group were significantly lower than that in the control group (25.5% vs. 41.51%, 14.45% vs. 30.19%; p < .05). The self-care ability of the intervention group was significantly better than that in the control group (t = 1.543 vs. 3.656 vs. 6.273, p < .05) at discharge, 3 months and 6 months after discharge. The interaction between time and grouping showed that the effect of time factor varied with the grouping. After intervention, there were significant differences in psychological resilience, self-care ability, complications and quality of life between the two groups at different observation points (p < .01). The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35 ± 4.25 vs. 60.45 ± 8.42, p < .01). CONCLUSIONS The hospital-family holistic care model based on 'Timing It Right' can effectively improve the psychological resilience, self-care ability and quality of life; reduce complications; and improve the health outcomes of patients with permanent enterostomy. RELEVANCE TO CLINICAL PRACTICE Patients with permanent enterostomy have different needs for nursing care at different stages of the disease, and they are dynamically changing. The hospital-family holistic care model based on 'Timing It Right' can effectively improve the health outcomes of patients with permanent enterostomy, which is worthy of clinical application.",2020,"The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35±4.25 vs 60.45±8.42, P < 0.01). ","['Patients with permanent colostomy', '108 patients with permanent enterostomy completed the study (90.76', 'patients with permanent enterostomy', 'Patients with permanent enterostomy based on the theory of ""Timing It Right', '119 patients with permanent enterostomy']","['hospital-family holistic care model', 'routine care、follow-up and hospital-family holistic care intervention based on ""Timing It Right"", while the control group received routine care and follow-up']","['5-year survival rate', 'resilience and quality of life', 'quality of life', 'psychological resilience, self-care ability, quality of life, reduce complications', 'resilience, self-care ability, complications and life quality', 'health outcomes', 'psychological resilience、 self-care ability、complications and quality of life', 'self-care ability', 'migration of observation time points']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0192973', 'cui_str': 'Permanent colostomy (procedure)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1442523', 'cui_str': 'Enterostomy (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0034380'}, {'cui': 'C0683253', 'cui_str': 'Psychological Resiliences'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform self-care activities'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",119.0,0.0286812,"The three evaluation indices of intervention group increased with the migration of observation time points and were significantly better than those of control group, especially the quality of life (84.35±4.25 vs 60.45±8.42, P < 0.01). ","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Jin Ling', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Nursing School of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Gui Fang', 'Initials': 'GF', 'LastName': 'Huang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Xiao Huan', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Fang Qin', 'Initials': 'FQ', 'LastName': 'Xue', 'Affiliation': 'Department of Gastroenterology, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Fujian Provincial Hospital, Fujian Medical University Affiliated Clinical Provincial Medical Institute, Fuzhou, China.'}]",Journal of clinical nursing,['10.1111/jocn.15199'] 3440,31298927,Osteochondral Autologous Transplantation Versus Dorsal Closing Wedge Metatarsal Osteotomy for the Treatment of Freiberg Infraction in Athletes: A Randomized Controlled Study With 3-Year Follow-up.,"BACKGROUND Dorsiflexion closing wedge metatarsal osteotomy (DCWMO) has been considered the traditional treatment of Freiberg disease. Several case reports presented osteochondral autologous transplantation (OAT) as an alternative treatment. PURPOSE/HYPOTHESIS The purpose was to compare the results of DCWMO versus OAT for the treatment of Freiberg infraction in an athletic population. It was hypothesized that OAT was superior to DCWMO regarding functional outcomes, pain, and the time that the athletes returned to training and to previous sport level. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS Between 2008 and 2013, 27 consecutive patients with Freiberg disease were randomly assigned to either the DCWMO group (14 patients) or the OAT group (13 patients). The primary outcomes collected were as follows: postoperative complications, range of motion of the metatarsophalangeal joint, length of the metatarsal, function of the foot (measured with the American Orthopaedic Foot and Ankle Society-lesser metatarsophalangeal-interphalangeal [AOFAS-LMI] score), and pain (assessed with the visual analog scale-foot and ankle score). RESULTS Mean follow-up was 46 months (range, 36-60 months). The mean ± SD AOFAS-LMI score in the DCWMO group was 63.4 ± 14.4 preoperatively, 81.8 ± 6.6 at 1 year postoperatively, and 84.4 ± 5.6 at 3 years postoperatively, while in the OAT group, it was 62.8 ± 14, 89.9 ± 7.1, and 92 ± 6.9, respectively ( P < .001). The differences in the AOFAS-LMI scores favoring the OAT group at 1 and 3 years reached statistical but not clinical significance. The mean visual analog scale-foot and ankle score was improved significantly from 48.1 ± 11.5 to 91.8 ± 9.5 in the DCWMO group and from 49.9 ± 10.9 to 95.4 ± 4.4 in the OAT group. There was a shortening of the metatarsals by a mean 1.9 ± 0.5 mm in the DCWMO group, as opposed to a metatarsal lengthening of 0.2 ± 0.1 mm in the OAT group. In the OAT group, patients were able to start training at 6 ± 1 weeks ( P < .001) and return to full sport action at 10 ± 2.5 weeks ( P < .05), while in the DCWMO group, the time was 8 ± 1.5 and 13 ± 2.5 weeks, respectively. CONCLUSION The authors concluded that OAT is equal to DCWMO. Acceptable clinical results were reported, as well as very low morbidity and early return to sport activities. That makes the OAT procedure a safe, effective, and optimal treatment for an athletic population experiencing Freiberg infraction.",2019,"In the OAT group, patients were able to start training at 6 ± 1 weeks ( P < .001) and return to full sport action at 10 ± 2.5 weeks ( P < .05), while in the DCWMO group, the time was 8 ± 1.5 and 13 ± 2.5 weeks, respectively. ","['athletic population experiencing Freiberg infraction', 'Freiberg Infraction in Athletes', 'Freiberg infraction in an athletic population', 'Between 2008 and 2013, 27 consecutive patients with Freiberg disease']","['OAT', 'DCWMO', 'DCWMO versus OAT', 'osteochondral autologous transplantation (OAT', 'Dorsiflexion closing wedge metatarsal osteotomy (DCWMO', 'Osteochondral Autologous Transplantation Versus Dorsal Closing Wedge Metatarsal Osteotomy']","['AOFAS-LMI scores', 'mean ± SD AOFAS-LMI score', 'mean visual analog scale-foot and ankle score', 'postoperative complications, range of motion of the metatarsophalangeal joint, length of the metatarsal, function of the foot (measured with the American Orthopaedic Foot and Ankle Society-lesser metatarsophalangeal-interphalangeal [AOFAS-LMI] score), and pain (assessed with the visual analog scale-foot and ankle score', 'low morbidity and early return to sport activities']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0264099', 'cui_str': ""Freiberg's infraction""}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture (morphologic abnormality)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal Joint'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0025584', 'cui_str': 'Metatarsals'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",27.0,0.0395844,"In the OAT group, patients were able to start training at 6 ± 1 weeks ( P < .001) and return to full sport action at 10 ± 2.5 weeks ( P < .05), while in the DCWMO group, the time was 8 ± 1.5 and 13 ± 2.5 weeks, respectively. ","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Georgiannos', 'Affiliation': 'First Orthopaedic Department, 424 Military General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsikopoulos', 'Affiliation': 'First Orthopaedic Department, 424 Military General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kitridis', 'Affiliation': 'First Orthopaedic Department, 424 Military General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Givisis', 'Affiliation': 'First Orthopaedic Department, ""George Papanikolaou"" University General Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Bisbinas', 'Affiliation': 'First Orthopaedic Department, 424 Military General Hospital, Thessaloniki, Greece.'}]",The American journal of sports medicine,['10.1177/0363546519859549'] 3441,31896168,Topical antibiotics for chronic suppurative otitis media.,"BACKGROUND Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics, the most common treatment for CSOM, act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as antiseptics or ear cleaning (aural toileting). OBJECTIVES To assess the effects of topical antibiotics (without steroids) for people with CSOM. SEARCH METHODS The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019. SELECTION CRITERIA We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B). Within each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting and b) on top of background treatment (such as systemic antibiotics). DATA COLLECTION AND ANALYSIS We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways. MAIN RESULTS We included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears. A: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that ""no medical side-effects and worsening of audiological measurements related to this topical medication were detected"" (very low-certainty evidence). B: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms) Four studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation. C: Comparisons of different topical antibiotics The certainty of evidence for all outcomes in these comparisons is very low. Quinolones versus aminoglycosides Seven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups. Quinolones versus aminoglycosides/polymyxin B combination ±gramicidin We identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A ""few"" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated). Others Other studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain. AUTHORS' CONCLUSIONS We are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.",2020,"Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other.","['participants (not ears); these had a total of 1797 participants', '214 participants', '734 participants) or', 'Chronic suppurative otitis media (CSOM', 'patients with CSOM', '190 participants) or topical ceftizoxime to no treatment (one study; 248 participants', 'participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks', 'B', 'people with CSOM', '17 studies with a total of 2198 participants', 'chronic suppurative otitis media']","['topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B', 'ciprofloxacin', 'aural toilet', 'antibiotic systemically (oral ciprofloxacin, injected ceftizoxime', 'ofloxacin', 'C', 'topical antibiotic (ciprofloxacin', 'topical antibiotics', 'trimethoprim/sulphacetamide/polymixin B combination', 'Quinolones versus aminoglycosides', 'Topical antibiotics', 'Quinolones', 'topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure', 'topical ciprofloxacin', 'neomycin/polymyxin B/gramicidin combination', 'topical gentamicin', 'topical antibiotics (without steroids', 'polymyxin B combination', 'placebo (saline', 'placebo', 'Topical antibiotics versus placebo', 'topical antibiotic a) alone or with aural toileting and b) on top of background treatment (such as systemic antibiotics', 'aminoglycoside (gentamicin, neomycin or tobramycin', 'rifampicin versus chloramphenicol']","['local irritation', 'health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation', ""resolution of ear discharge or 'dry ear"", 'ear pain', 'hearing, serious complications and ototoxicity measured in several ways', 'resolution of discharge', 'resolution of discharge occurring', 'ear pain or discomfort/local irritation']","[{'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0271454', 'cui_str': 'Chronic purulent otitis media (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0007560', 'cui_str': 'Ceftizoxime'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0155540', 'cui_str': 'Otorrhea (disorder)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C1140607', 'cui_str': 'Toilets'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0007560', 'cui_str': 'Ceftizoxime'}, {'cui': 'C0028902', 'cui_str': 'Ofloxacin'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038670', 'cui_str': 'Sulfacetamide'}, {'cui': 'C0034428', 'cui_str': 'Oxoquinolines'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0013444', 'cui_str': 'External Ear Canal'}, {'cui': 'C1154187', 'cui_str': 'Ear Drops'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1445775', 'cui_str': 'Neomycin / Polymyxin B'}, {'cui': 'C0018165', 'cui_str': 'Gramicidin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0027603', 'cui_str': 'Neomycin'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0155540', 'cui_str': 'Otorrhea (disorder)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",401.0,0.385148,"Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other.","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Brennan-Jones', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, 15 Hospital Avenue, Perth, Western Australia, Australia, 6009.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Head', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Cochrane ENT, UK Cochrane Centre, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK.'}, {'ForeName': 'Lee-Yee', 'Initials': 'LY', 'LastName': 'Chong', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Cochrane ENT, UK Cochrane Centre, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'Cochrane UK, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK, OX2 7LG.'}, {'ForeName': 'Anne Gm', 'Initials': 'AG', 'LastName': 'Schilder', 'Affiliation': 'Faculty of Brain Sciences, University College London, evidENT, Ear Institute, 330 Grays Inn Road, London, UK, WC1X 8DA.'}, {'ForeName': 'Mahmood F', 'Initials': 'MF', 'LastName': 'Bhutta', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Department of Otolaryngology, Eastern Road, Brighton, UK, BN2 5BE.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013051.pub2'] 3442,31326730,Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN).,"BACKGROUND Coagulation activation is a hallmark of cancer, and anticoagulants have shown tumour-inhibiting properties. However, recent trials have failed to demonstrate improved survival with low-molecular-weight heparin (LMWH) in cancer populations. This has raised the question of suboptimal adherence as a possible explanation for the lack of benefit. Still, there is no standardised method to directly monitor LMWH in patient plasma. Here, we directly determine LMWH levels in patients using the Heparin Red assay to objectively assess adherence and how this associates with the patient outcome in the RASTEN trial. METHODS RASTEN is a multicentre, randomised phase III trial investigating if the addition of LMWH to standard therapy can improve survival in small-cell lung cancer. LMWH was measured in plasma (N = 258) by the Heparin Red assay and compared with the anti-factor Xa (anti-FXa) activity assay. RESULTS Both methods could differentiate patients in the LMWH arm from the control arm and patients receiving therapeutic LMWH owing to thrombosis. Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red. No survival benefits were found in the adherent subgroup compared with the control arm (hazard ratio [HR]: 1.26; 95% confidence interval [CI]: 0.95-1.67; P = 0.105 and HR: 1.19; 95% CI: 0.89-1.60; P = 0.248 for anti-FXa and Heparin Red, respectively). Heparin Red could define patients with high probability of adherence to LMWH treatment, which warrants prospective studies for further validation. Our finding that the LMWH-adherent subpopulation did not show improved survival excludes that the negative outcome of RASTEN was due to poor adherence.",2019,Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red.,['small-cell lung cancer'],"['LMWH', 'Heparin Red', 'Heparin Red assay']","['survival excludes', 'survival', 'LMWH', 'Receiver Operating Characteristic (ROC) analysis yielded adherence rates', 'survival benefits']","[{'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",,0.171485,Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for Heparin Red.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gezelius', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden; Department of Respiratory Medicine, Skåne University Hospital, Entrégatan 7, SE-221 85, Lund, Sweden. Electronic address: Emelie.gezelius@med.lu.se.'}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Bendahl', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gonçalves de Oliveira', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ek', 'Affiliation': 'Department of Respiratory Medicine, Skåne University Hospital, Entrégatan 7, SE-221 85, Lund, Sweden.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Department of Respiratory Medicine, Sahlgrenska University Hospital, SE-413 45, Gothenburg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sundberg', 'Affiliation': 'Department of Hematology, Radiophysics and Oncology, Skåne University Hospital, Lasarettsgatan 23A, SE-221 85, Lund, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Strandberg', 'Affiliation': 'Department of Clinical Chemistry, Institution of Laboratory Medicine, Lund University, Inga Marie Nilssons Gata 53, SE-214 28, Malmö, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krämer', 'Affiliation': 'Inorganic Chemistry Institute, Heidelberg University, Im Neuenheimer Feld 270, 60129, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Belting', 'Affiliation': 'Department of Clinical Sciences, Lund, Division of Oncology, Lund University, Barngatan 4, SE-221 85, Lund Sweden; Department of Hematology, Radiophysics and Oncology, Skåne University Hospital, Lasarettsgatan 23A, SE-221 85, Lund, Sweden; Department of Immunology, Pathology, and Genetics, Uppsala University, Rudbecklaboratoriet, SE-751 85, Uppsala, Sweden.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.06.015'] 3443,32045673,Bioequivalence studies of inhaled indacaterol maleate in healthy Chinese volunteers under gastrointestinal non-blocking or blocking with concomitant charcoal administration.,"BACKGROUND Indacaterol is one of the long-acting beta 2 -adrenergic agonists, referred as first-line monotherapy for Chronic obstructive pulmonary disease since 2011. Generic products are encouraged to benefit the large COPD patients in China, in which can provide more choices association with reduced cost and improve the quality of patient life. OBJECTIVE The three-part study consists of two independent cohorts of thirty-six subjects, aimed to evaluate the bioequivalence (BE) of two indacaterol formulations in gastrointestinal (GI) absorption charcoal-block or non-block conditions. One pilot study performed in six healthy subjects to determine the blocking effect of a new charcoal-based regimen on GI absorption after orally inhalation of indacaterol. METHODS Two BE studies were conducted with a randomized, open-label, 2-period crossover design in two independent 36-healthy-subject cohorts, equivalence in systemic and lung deposition was assessed after inhalation of a single dose of 150 μg indacaterol (test or reference formulation) alone or concomitant administration of charcoal. The charcoal-based regimen was improved by optimizing the dose and number of doses, and its blocking efficacy against GI absorption was assessed in a pilot study. Six healthy subjects received 9 g charcoal 10 min before, immediately after and 2 h after indacaterol (3 g/100 ml water × 3 times). Blood collected at predetermined time points up to 72 h. Plasma indacaterol concentrations were determined using HPLC-MS/MS. Pharmacokinetics parameters were calculated with non-compartment analysis. Equivalences were concluded if the 90% confidence interval (CI) for test: reference of C max and AUC 0-t fell within the limits of 0.8-1.25. RESULTS Indacaterol was undetectable in plasma samples in pilot study. The T/R ratio of the geometric mean C max and AUC 0-t was 109.9% (90% CI, 106.1-113.8%) and 104.8% (90% CI, 101.5-108.1%) for charcoal-block subjects and 105.4% (90% CI, 99.8% ~ 111.3%), and 101.0% (90% CI, 97.7%-104.4%) for non-block subjects. No serious adverse events were reported. CONCLUSIONS The results showed that 150 μg indacaterol (+/- 9 g charcoal) was well tolerated in all subjects. The two formulations are bioequivalent in terms of the rate and absorption both in charcoal-block and non-block conditions. The improved charcoal-based regimen demonstrated to be effective and fully blockade of GI absorption of indacaterol.",2020,The two formulations are bioequivalent in terms of the rate and absorption both in charcoal-block and non-block conditions.,"['Six healthy subjects', 'Chronic obstructive pulmonary disease since 2011', 'healthy Chinese volunteers under gastrointestinal non-blocking or blocking with concomitant charcoal administration', 'six healthy subjects']","['indacaterol formulations in gastrointestinal (GI) absorption charcoal-block or non-block conditions', '150 μg indacaterol (test or reference formulation) alone or concomitant administration of charcoal', 'indacaterol ', 'inhaled indacaterol maleate', 'new charcoal-based regimen on GI absorption after orally inhalation of indacaterol']","['T/R ratio of the geometric mean C max and AUC 0-t', 'serious adverse events', 'Plasma indacaterol concentrations', 'Pharmacokinetics parameters', 'systemic and lung deposition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3714657', 'cui_str': 'Gut Absorption'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C2920417', 'cui_str': 'indacaterol maleate'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}]",6.0,0.0912099,The two formulations are bioequivalent in terms of the rate and absorption both in charcoal-block and non-block conditions.,"[{'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China; Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, China. Electronic address: cellahuang1988@163.com.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China; Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, China. Electronic address: ygp9880@126.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101902'] 3444,32056501,"Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial).","Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed at comparing the efficacy and safety of both techniques in patients with solid or predominantly solid BNTN. Methods: This six-month, single-use, randomized, open-label, parallel trial compared the following primary endpoints between the RFA and LA groups six months after treatment: (i) nodule volume reduction expressed as a percentage of nodule volume at baseline; (ii) proportion of nodules with more than 50% reduction (successful rate). We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy for diagnosis. Patients were randomly assigned (1:1) to receive LA or RFA. Safety was assessed in all randomly assigned participants. Results: Sixty patients were randomly assigned to receive either RFA or LA (1:1) between January 2016 and November 2018. Both groups were similar in basal nodule volume, thyroid function, histology, symptoms/cosmetic score, and procedure time. At six months, the nodule volume reduction was 64.3% (95% confidence interval, CI 57.5-71.2) in the RFA group and 53.2% ([CI 47.2-95.2]; p  = 0.02) in the LA group. This effect was also confirmed in the linear regression model adjusted for age, baseline volume, and proportion of cellular component (LA vs. RFA percent change Delta = -12.8, p  = 0.02). No significant difference was observed in success rate six months after treatment (RFA vs. LA: 86.7% vs. 66.7%, p  = 0.13) or in thyrotropin level between the groups. Although improved, no significant difference was observed between RFA and LA for compressive symptoms (RFA: 2.13 vs. 3.9, p  < 0 · 001; LA: 2.4 vs. 3.87, p  < 0.001) and cosmetic score (RFA: 1.65 vs. 2.2, p  < 0.001; LA: 1.85 vs. 2.2, p  < 0.001). The adverse event rates (local pain, dysphonia, thyrotoxicosis, fever, hematoma) were 37% ( n  = 11) and 43% ( n  = 13) for RFA and LA, respectively, with no requirement for hospitalization. Conclusion: Although the success rate was similar in the RFA and LA groups, RFA achieved a significantly larger nodule volume reduction at six months.",2020,"No significant difference was observed in success rate 6-month after treatment (RFA vs LA: 86·7% vs 66·7%, p=0·13) or in thyrotropin level between the groups.","['enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year', 'patients with solid or predominantly solid BNTN', 'Sixty patients', 'benign non-functioning thyroid nodules']","['Laser Ablation versus Radiofrequency Ablation', 'RFA and LA', 'RFA or LA', 'laser ablation (LA) and radiofrequency ablation (RFA', 'Nodules underwent core needle biopsy (CNB', 'LA or RFA']","['efficacy and safety', 'cosmetic score', 'nodule volume reduction', 'basal nodule volume, thyroid function, histology, symptoms/cosmetic score, and procedure time', 'success rate', 'success rate 6-month', 'adverse event rates (local pain, dysphonia, thyrotoxicosis, fever, hematoma', 'thyrotropin level', 'RFA and LA for compressive symptoms', 'Safety']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0154141', 'cui_str': 'Toxic uninodular goiter with thyrotoxic crisis (disorder)'}]","[{'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C1318309', 'cui_str': 'Biopsy, Large-Core Needle'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0040156', 'cui_str': 'Thyrotoxicosis'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.111993,"No significant difference was observed in success rate 6-month after treatment (RFA vs LA: 86·7% vs 66·7%, p=0·13) or in thyrotropin level between the groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cesareo', 'Affiliation': 'Unit of Metabolic Diseases, ""S.M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Claudio Maurizio', 'Initials': 'CM', 'LastName': 'Pacella', 'Affiliation': 'Department of Diagnostic Imaging and Interventional Radiology, Regina Apostolorum Hospital, Albano Laziale, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Pasqualini', 'Affiliation': 'Department of Radiology and ""S.M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Campagna', 'Affiliation': 'Department of Internal Medicine, ""S.M. Goretti"" Hospital, Latina, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Iozzino', 'Affiliation': 'Department of Diagnostic Imaging and Interventional Radiology, Regina Apostolorum Hospital, Albano Laziale, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallo', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Lauria Pantano', 'Affiliation': 'Department of Internal Medicine, University Hospital Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cianni', 'Affiliation': 'Department of Interventional Radiology, S. Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Pedone', 'Affiliation': 'Geriatric Unit, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Taffon', 'Affiliation': 'Pathology Unit, University Hospital Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Crescenzi', 'Affiliation': 'Pathology Unit, University Hospital Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Manfrini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Palermo', 'Affiliation': 'Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0660'] 3445,31892650,Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway.,"INTRODUCTION Health professions need to prepare for the increase of older patients with osteoarthritis requiring health services including those requiring total joint arthroplasty (TJA). The primary objective of this study is to assess the effect of a tailored prehabilitation programme of older patients awaiting primary surgery for total hip replacement on physical function measured by walking speed within 1 week after intervention as well as 6 weeks and 3 months after TJA surgery. METHODS AND ANALYSIS This is a single-blinded randomised controlled trial. The participants are 70 years or older, scheduled for primary total hip replacement due to late stage osteoarthritis. The intervention group will receive patient education and exercise for 6-12 weeks. The control group will receive care as usual. The primary outcome is gait speed. Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness. Estimated sample size is 150 participants randomised into the two arms. The data will be analysed following the intention-to-treat principle with methods for repeated measurements. ETHICS AND DISSEMINATION The project proposal has been approved by The Regional Committee for Medical Research Ethics in South Norway (ref no. 2018/503). The results will be published in peer-reviewed articles. TRIAL REGISTRATION NUMBER NCT03602105.",2019,"Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness.","['older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway', 'older patients awaiting primary surgery for total hip replacement on physical function', '150 participants randomised into the two arms', 'older patients with osteoarthritis requiring health services including those requiring total joint arthroplasty (TJA', 'participants are 70 years or older, scheduled for primary total hip replacement due to late stage osteoarthritis']","['patient education and exercise', 'tailored prehabilitation programme']","['gait speed', 'lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}]","[{'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",150.0,0.152471,"Secondary outcomes are lower body strength, mobility, aerobic capacity, activity of daily living, length of stay at the hospital, referral to an inpatient rehabilitation clinic, pain, quality of life and cost-effectiveness.","[{'ForeName': 'Odd-Einar', 'Initials': 'OE', 'LastName': 'Svinøy', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway oddeina@oslomet.no.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'May Arna', 'Initials': 'MA', 'LastName': 'Risberg', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Hilde', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-031626'] 3446,32150584,A simulation based difficult conversations intervention for neonatal intensive care unit nurse practitioners: A randomized controlled trial.,"BACKGROUND Neonatal nurse practitioners are often the front line providers in discussing unexpected news with parents. This study seeks to evaluate whether a simulation based Difficult Conversations Workshop for neonatal nurse practitioners leads to improved skills in conducting difficult conversations. METHODS We performed a randomized controlled study of a simulation based Difficult Conversations Workshop for neonatal nurse practitioners (n = 13) in a regional level IV neonatal intensive care unit to test the hypothesis that this intervention would improve communication skills. A simulated test conversation was performed after the workshop by the intervention group and before the workshop by the control group. Two independent blinded content experts scored each conversation using a quantitative communication skills performance checklist and by assigning an empathy score. Standard statistical analysis was performed. RESULTS Randomization occurred as follows: n = 5 to the intervention group, n = 7 to the control group. All participants were analyzed in each group. Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter. CONCLUSIONS Our study demonstrates that a lecture and simulation based Difficult Conversations Workshop for neonatal nurse practitioners improves objective communication skills and empathy in conducting difficult conversations.",2020,"Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter. ","['neonatal intensive care unit nurse practitioners', 'neonatal nurse practitioners', 'neonatal nurse practitioners (n = 13) in a regional level IV neonatal intensive care unit']","['A simulation based difficult conversations intervention', 'lecture and simulation based Difficult Conversations Workshop', 'simulation based Difficult Conversations Workshop']","[""participants' empathy score"", 'communication skills']","[{'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0600089', 'cui_str': 'Nurses, Neonatal'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",13.0,0.0744612,"Participation in the simulation based Difficult Conversations Workshop increases participants' empathy score (p = 0.015) and the use of communication skills (p = 0.013) in a simulated clinical encounter. ","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bowen', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Lally', 'Affiliation': 'Program in Palliative Care, Care New England Health System, Providence, RI, United States of America.'}, {'ForeName': 'Francine R', 'Initials': 'FR', 'LastName': 'Pingitore', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tucker', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'McGowan', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}, {'ForeName': 'Beatrice E', 'Initials': 'BE', 'LastName': 'Lechner', 'Affiliation': 'Department of Neonatology, Women & Infants Hospital, Providence, RI, United States of America.'}]",PloS one,['10.1371/journal.pone.0229895'] 3447,32134977,Heterogeneous treatment effects of a text messaging smoking cessation intervention among university students.,"INTRODUCTION Despite tobacco being an important preventable factor with respect to ill health and death, it is a legal substance that harms and kills many of those who use it. Text messaging smoking cessation interventions have been evaluated in a variety of contexts, and are generally considered to have a positive effect on smoking cessation success. In order for text messaging interventions to continue to be useful as prevalence of smoking decreases, it may be necessary to tailor the interventions to specific individuals. However, little is known with regard to who benefits the most and least from existing interventions. METHODS In order to identify heterogenous treatment effects, we analyzed data from a randomized controlled trial of a text messaging smoking cessation intervention targeting university students in Sweden. We used a Bayesian hierarchical model where the outcome was modelled using logistic regression, and so-called horseshoe priors were used for coefficients. Predictive performance of the model, and heterogeneous treatment effects, were calculated using cross-validation over the trial data. RESULTS Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week. No heterogeneity was found with respect to sex, number of years smoking, or the use of snuff. DISCUSSION Results emphasize that individuals with a more developed dependence of nicotine may have a harder time quitting smoking even with support. This questions the dissemination and development of text messaging interventions to university students in the future, as they may not be the optimal choice of intervention for those with a more developed dependence. On the other hand, text messaging interventions may be useful to disseminate among university students that are at risk of developing a strong dependence. TRIAL REGISTRATION International Standard Randomized Controlled Trial Number (ISRCTN): 75766527; http://www.controlled-trials.com/ISRCTN75766527.",2020,"RESULTS Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week.","['targeting university students in Sweden', 'university students']",['text messaging smoking cessation intervention'],[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0621369,"RESULTS Findings from the study of heterogenous treatment effects identified less effect of the intervention among university students with stronger dependence of nicotine and students who smoke a greater quantity of cigarettes per week.","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",PloS one,['10.1371/journal.pone.0229637'] 3448,32134961,"Maternal perceptions of father involvement among refugee and disadvantaged families in Beirut, Lebanon.","The role of fathers in (co-)parenting their children among refugee and disadvantaged families in low and middle-income countries (LMICs) remains poorly understood. This study sought to examine the associations among mothers' perceptions of their husband's involvement (hereafter referred to as paternal involvement), and her perceptions of her own well-being and a number of other variables, as well as observed mother-child interactions in families living in refugee and disadvantaged communities in Beirut, Lebanon. We analyzed baseline data from 104 mother-child dyads (mean age of children = 4.34 years; range = 2.05 to 7.93 years of age) who participated in a randomized controlled trial aimed at evaluating the impact of the Mother-Child Education Program in Beirut. In addition to the mother's perception of paternal involvement and the videotaped mother-child interactions, data were collected concerning the mother's well-being and her level of social support, as well as her level of stress as a parent and the way her children were disciplined in the family. Mother-child pairs were videotaped while completing a puzzle together and dyadic interactions were coded. Path analysis showed that paternal involvement was significantly associated with a higher level of maternal well-being and lower distress levels. In addition, higher levels of maternal distress were associated with higher levels of harsh discipline and parenting stress. Correlation analysis showed that higher perceptions of paternal involvement were associated with more positive affect displayed by the child, more positive regard for the child, and better mother-child synchrony during the dyadic interactions. Limitations include the cross-sectional design and the modest sample size, which hinder causal inferences and generalizability of the findings. These preliminary findings suggest that higher levels of paternal involvement may have an impact on markers of maternal mental health and positive mother-child interactions in families living in disadvantaged communities or humanitarian settings. Paternal involvement should be considered when designing and implementing parenting programs in LMICs.",2020,"Correlation analysis showed that higher perceptions of paternal involvement were associated with more positive affect displayed by the child, more positive regard for the child, and better mother-child synchrony during the dyadic interactions.","['104 mother-child dyads (mean age of children = 4.34 years; range = 2.05 to 7.93 years of age', 'Maternal perceptions of father involvement among refugee and disadvantaged families in Beirut, Lebanon', ""mothers' perceptions of their husband's involvement (hereafter referred to as paternal involvement""]",[],"['higher level of maternal well-being and lower distress levels', 'maternal distress']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023190', 'cui_str': 'Lebanese Republic'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress (disorder)'}]",,0.0302916,"Correlation analysis showed that higher perceptions of paternal involvement were associated with more positive affect displayed by the child, more positive regard for the child, and better mother-child synchrony during the dyadic interactions.","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Hein', 'Affiliation': 'Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bick', 'Affiliation': 'Department of Psychology, University of Houston, Houston, Texas, United States of America.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Issa', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Aoude', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Maalouf', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Abir', 'Initials': 'A', 'LastName': 'Awar', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Nourallah', 'Affiliation': 'Arab Resource Collective, Beirut, Lebanon.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Zonderman', 'Affiliation': 'UChicago Medicine, The University of Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Householder', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Katsovich', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Khoshnood', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Psychology, University of Delaware, Newark, Delaware, United States of America.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Salah', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Pia R', 'Initials': 'PR', 'LastName': 'Britto', 'Affiliation': 'UNICEF, New York, New York, United States of America.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}, {'ForeName': 'Liliana Angelica', 'Initials': 'LA', 'LastName': 'Ponguta', 'Affiliation': 'Child Study Center, Yale University, New Haven, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0229670'] 3449,31892662,Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial.,"INTRODUCTION Preschoolers have the highest rate of emergency visits and hospitalisations for asthma exacerbations of all age groups, with most triggered by upper respiratory tract infections (URTIs) and occurring in the fall or winter. Vitamin D insufficiency is highly prevalent in Canadian preschoolers with recurrent asthma exacerbations, particularly in winter. It is associated with more URTIs and, in patients with asthma, more oral corticosteroid (OCS) use. Although evidence suggests that vitamin D supplements significantly decrease URTIs and asthma exacerbations requiring OCS, there is insufficient data in preschoolers. This study aims to determine the impact of vitamin D 3 supplementation on exacerbations requiring OCS, in preschoolers with recurrent URTI-induced asthma exacerbations. METHODS AND ANALYSIS This is a phase III, randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D 3 supplementation in children aged 1-5 years, with asthma triggered by URTIs and a recent history of frequent URTIs and OCS use. Children (n=865) will be recruited in the fall and early winter and followed for 7 months. They will be randomised to either the (1) intervention: two oral boluses of 100 000 international unit (IU) vitamin D 3 (3.5 months apart) with 400 IU vitamin D 3 daily; or (2) control: identical placebo boluses with daily placebo. The primary outcome is the number of exacerbations requiring OCS per child, documented by medical and pharmacy records. Secondary outcomes include number of laboratory-confirmed viral URTIs, exacerbation duration and severity, parent functional status, healthcare use, treatment deintensification, cost and safety. ETHICS AND DISSEMINATION This study has received ethical approval from all sites. Results will be disseminated via international conferences and manuscripts targeting paediatricians and respirologists, and to families of asthmatic children via our Quebec parents-partners outreach programme. If proven effective, findings may markedly influence the management of URTI-induced asthma in high-morbidity preschoolers and could be directly implemented into practice with an update to clinical guidelines. TRIAL REGISTRATION NUMBER NCT03365687.",2019,"INTRODUCTION Preschoolers have the highest rate of emergency visits and hospitalisations for asthma exacerbations of all age groups, with most triggered by upper respiratory tract infections (URTIs) and occurring in the fall or winter.","['preschoolers with recurrent URTI-induced asthma exacerbations', 'children aged 1-5 years, with asthma triggered by URTIs and a recent history of frequent URTIs and OCS use', 'exacerbations of asthma in preschoolers (DIVA', 'Children (n=865) will be recruited in the fall and early winter and followed for 7 months', 'Canadian preschoolers with recurrent asthma exacerbations']","['vitamin D supplements', 'Vitamin D', 'placebo boluses with daily placebo', 'vitamin D 3 supplementation', 'placebo', 'Vitamin D insufficiency']","['number of exacerbations requiring OCS per child, documented by medical and pharmacy records', 'number of laboratory-confirmed viral URTIs, exacerbation duration and severity, parent functional status, healthcare use, treatment deintensification, cost and safety', 'exacerbations requiring OCS']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1303029', 'cui_str': 'Asthma trigger'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma (disorder)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.682626,"INTRODUCTION Preschoolers have the highest rate of emergency visits and hospitalisations for asthma exacerbations of all age groups, with most triggered by upper respiratory tract infections (URTIs) and occurring in the fall or winter.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Jensen', 'Affiliation': 'Priority Research Centre Grow Up Well, School of Medicine & Public Health, Faculty of Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Francine M', 'Initials': 'FM', 'LastName': 'Ducharme', 'Affiliation': 'Department of Social & Preventive Medicine, University of Montreal, Montreal, Québec, Canada francine.m.ducharme@umontreal.ca.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Alos', 'Affiliation': 'Department of Social & Preventive Medicine, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Mailhot', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'Research Centre, CHU Sainte-Justine, Montreal, Québec, Canada.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'White', 'Affiliation': 'Department of Physiology, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sadatsafavi', 'Affiliation': 'Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khamessan', 'Affiliation': 'Euro-Pharm International Canada Inc, Montreal, Québec, Canada.'}, {'ForeName': 'Sze Man', 'Initials': 'SM', 'LastName': 'Tse', 'Affiliation': 'Department of Social & Preventive Medicine, University of Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadehfar', 'Affiliation': ""Department of Pediatrics, Montreal Children's Hospital, Montreal, Québec, Canada.""}, {'ForeName': 'Dirk E', 'Initials': 'DE', 'LastName': 'Bock', 'Affiliation': 'Department of Pediatrics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Daigneault', 'Affiliation': 'Department of Pediatrics, Centre Mère-Enfant du CHU de Québec, Quebec City, Quebec, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Lemire', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatrics, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Dhenuka', 'Initials': 'D', 'LastName': 'Radhakrishnan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-033075'] 3450,31892665,Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial.,"INTRODUCTION For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH. METHODS AND ANALYSIS A total of 280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1 week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1 week, 1 month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5. ETHICS AND DISSEMINATION Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences. TRIAL REGISTRATION NUMBER ChiCTR1800015727; Pre-results.",2019,A total of 280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited.,"['lumbar disc herniation', '280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited']","['PTED versus PMTM', 'minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM', 'percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM']","['Oswestry Disability Index scores', 'Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal (qualifier value)'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy (procedure)'}]","[{'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",280.0,0.200194,A total of 280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited.,"[{'ForeName': 'Ze Yan', 'Initials': 'ZY', 'LastName': 'Liang', 'Affiliation': 'Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yuan Dong', 'Initials': 'YD', 'LastName': 'Zhuang', 'Affiliation': 'Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Chun Mei', 'Initials': 'CM', 'LastName': 'Chen', 'Affiliation': 'Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China cmchen2009@sina.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.'}]",BMJ open,['10.1136/bmjopen-2019-033888'] 3451,31822251,Ethnicity and Other Determinants of Quality of Functional Outcome in Acute Ischemic Stroke: The ENCHANTED Trial.,"Background and Purpose- Patient-centered outcomes are important. We aimed to determine predictors of health-related quality of life (HRQoL) and develop utility-weighted modified Rankin Scale (mRS) scores in thrombolyzed acute ischemic stroke patients from both arms of ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study). Methods- ENCHANTED was an international quasi-factorial clinical trial of different doses of intravenous alteplase and intensities of blood pressure control in acute ischemic stroke patients, with outcomes on the 5-Dimensional European Quality of Life Scale and mRS assessed at 90 days post-randomization. Logistic regression models were used to identify baseline predictors of poor HRQoL (≤mean 5-Dimensional European Quality of Life Scale utility scores). Ordinary least squares regression derived utility-weighted mRS scores. Results- In 4016 acute ischemic stroke patients with complete 5-Dimensional European Quality of Life Scale and mRS data, independent predictors of poor HRQoL were older age (odds ratio, 1.19 [95% CI, 1.12-1.27], per 10-year increase), non-Asian ethnicity (1.91 [1.61-2.27]), greater stroke severity on the National Institutes of Health Stroke Scale (1.11 [1.09-1.12]), diabetes mellitus (1.41 [1.18-1.69]), premorbid disability (mRS score 1 versus 0; 1.62 [1.33-1.97]), large vessel atheromatous pathogenesis (1.32 [1.12-1.54]), and proxy respondent (2.35 [2.01-2.74]). Sensitivity analyses indicate the ethnicity influence on HRQoL was driven by the high proportion of Chinese (62.9% of Asian) participants with better HRQoL compared with non-Chinese or other Asian groups. Derived utility values across mRS scores 0 to 5 were 0.977, 0.885, 0.748, 0.576, 0.194, and -0.174, respectively. Correlations between mRS and 5-Dimensional European Quality of Life Scale scores were stronger in Asians. Conclusions- HRQoL is worse after thrombolyzed acute ischemic stroke in the elderly, non-Asians, with greater initial severity, diabetes mellitus, premorbid disability, due to large vessel atheroma, and proxy assessment. The broader significance of better HRQoL in Asians is tempered by Chinese participants dominating analyses. From utility-weighted mRS scores indicating the greatest steps in mRS scores are between 5 and 3, treatments to avoid major disability provide the greatest benefits for patients. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01422616.",2020,"Derived utility values across mRS scores 0 to 5 were 0.977, 0.885, 0.748, 0.576, 0.194, and -0.174, respectively.","['Acute Ischemic Stroke', 'acute ischemic stroke patients', 'thrombolyzed acute ischemic stroke patients', '4016 acute ischemic stroke patients with']","[' and Purpose', 'Methods', 'Conclusions- HRQoL']","['premorbid disability', 'stroke severity on the National Institutes of Health Stroke Scale', 'complete 5-Dimensional European Quality of Life Scale and mRS data', '5-Dimensional European Quality of Life Scale and mRS', 'large vessel atheromatous pathogenesis', 'health-related quality of life (HRQoL) and develop utility-weighted modified Rankin Scale (mRS) scores', 'poor HRQoL (≤mean 5-Dimensional European Quality of Life Scale utility scores', 'mRS and 5-Dimensional European Quality of Life Scale scores', 'diabetes mellitus']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0699748', 'cui_str': 'Pathogenesis (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",,0.0938684,"Derived utility values across mRS scores 0 to 5 were 0.977, 0.885, 0.748, 0.576, 0.194, and -0.174, respectively.","[{'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health (H.A.), Fukuoka University, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, United Kingdom (T.R.).'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago (P.M.L.).'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'From the George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.C., X.W., C.D., J.L., M.L.H., R.I.L., J.C., C.S.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027639'] 3452,31826736,CSPS.com Trial of Adding Cilostazol to Antiplatelet Therapy to Reduce Recurrent Stroke.,,2020,,[],['Cilostazol'],['Recurrent Stroke'],[],"[{'cui': 'C0055729', 'cui_str': 'cilostazol'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.0333931,,"[{'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'From the Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth; and Department of Neurology, Sir Charles Gairdner Hospital, Perth, Australia.'}]",Stroke,['10.1161/STROKEAHA.119.028409'] 3453,31928032,Vignette responses and future intentions in a health decision-making context: How well do they correlate?,"INTRODUCTION Vignettes are commonly used to assess health care decision making when it is impractical or unethical to use experimental methods. We sought to determine whether decisions made in response to hypothetical vignettes requiring medical decisions for self or parents related to reported future likelihoods of engaging in similar behaviors. METHOD Respondents ( n = 1,862) were adults recruited in person in general community settings. Individuals were assigned randomly to read 1 of a variety of vignettes that presented various medical problems being experienced either by oneself or a parent in a hypothetical context. Individuals reported their likelihoods of hiring a health care advocate to perform a variety of tasks in the context of the vignette and their likelihoods of hiring a health care advocate for themselves or their own parents in the future. Multigroup analysis was performed to estimate a latent variable path model for the vignette hiring questions and real-world future intention to hire by condition. RESULTS The configural model was retained. Tests of invariance for the correlation between future intentions to hire and the latent variable from the vignette decision making indicated a significant difference between self and parent conditions. However, moderate relationships existed between vignette responses and future intentions in both conditions, with approximately 25% of the variance in personal, future intentions being accounted for by vignette responses. DISCUSSION Our findings support the continued study of vignettes as a possible tool to measure behavioral intentions in the context of positive and negative health care decisions impacting self and others. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"However, moderate relationships existed between vignette responses and future intentions in both conditions, with approximately 25% of the variance in personal, future intentions being accounted for by vignette responses. ","['Respondents ( n = 1,862) were adults recruited in person in general community settings']",[],[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],2020.0,0.0380534,"However, moderate relationships existed between vignette responses and future intentions in both conditions, with approximately 25% of the variance in personal, future intentions being accounted for by vignette responses. ","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Van Liew', 'Affiliation': 'College of Health Solutions, Arizona State University.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Leon', 'Affiliation': 'Department of Psychology, Grand Canyon University.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University.'}, {'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Cronan', 'Affiliation': 'Department of Psychology, San Diego State University.'}]","Families, systems & health : the journal of collaborative family healthcare",['10.1037/fsh0000464'] 3454,32092472,"Determinants of response to bronchodilator in patients with cough variant asthma- A randomized, single-blinded, placebo-controlled study.","BACKGROUND Not all patients with cough variant asthma (CVA) show responsiveness to bronchodilators (RB) in clinic. Whether there are specific clinical and pathophysiological features can indicate RB in patients with CVA needs further investigation. Thus, we aimed to investigate the RB in patients with CVA and associated factors. METHODS Forty-two CVA patients were randomized in a 2:1 ratio to receive oral bambuterol hydrochloride (10 mg, once daily, for 3 days) or matched placebo, 36 patients (24 with bronchodilator and 12 with placebo) completed the study eventually. RB was considered when cough visual analogue scale (VAS) score decreased 30% or more after 3 days treatment. The baseline clinical and pathophysiological characteristics between patients with RB and patients without RB were compared. CRS was presented with the lowest concentration of capsaicin inducing at least 5 coughing (C5). RESULTS The responsive rate of patients with bronchodilator was significantly higher than that with placebo (62.5% vs 16.7%, p < 0.01). Patients with RB showed a significant greater mean decline of FEV 1 % predicted after bronchial provocation (26.7% vs 22.4%, p < 0.05) and higher geometric mean of sputum eosinophils (1.37 vs 0.69, p < 0.05) as compared with these without RB. No significant differences in sputum neutrophil, Log C5 were found between patients with RB and patients without RB. There was a moderate correlation between the decline of FEV 1 % pred and RB (r s  = 0.443, p < 0.05). The regression analysis showed that nocturnal cough was a predictor of RB (OR, 7.33, 95% CI: 1.11-48.26, p = 0.038). No adverse events were reported by all of the patients after the study. CONCLUSION More than one-third of patients with CVA do not respond to bronchodilator treatment, indicating that the response to bronchodilator should not be a diagnostic requirement of CVA. CVA patients with higher airway responsiveness will more likely respond to bronchodilator. Cough of CVA might be elicited by different mechanisms, which suggests that CVA could be divided into two phenotypes according to the response to bronchodilators.",2020,"There was a moderate correlation between the decline of FEV 1 % pred and RB (r s  = 0.443, p < 0.05).","['patients with cough variant asthma', 'patients with CVA', 'Forty-two CVA patients', 'CVA patients with higher airway responsiveness', 'patients with cough variant asthma (CVA', 'patients with RB and patients without RB', '36 patients (24 with', 'patients with CVA and associated factors']","['placebo', 'oral bambuterol hydrochloride', 'bronchodilator and 12 with placebo', 'bronchodilator']","['mean decline of FEV', 'adverse events', 'nocturnal cough', 'cough visual analogue scale (VAS) score', 'geometric mean of sputum eosinophils', 'sputum neutrophil, Log C5', 'responsive rate of patients with bronchodilator']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0694548', 'cui_str': 'Cough variant asthma (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0771061', 'cui_str': 'Bambuterol hydrochloride'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231912', 'cui_str': 'Nocturnal cough (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}]",42.0,0.0924459,"There was a moderate correlation between the decline of FEV 1 % pred and RB (r s  = 0.443, p < 0.05).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Baojuan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Kefang', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': 'State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, China. Electronic address: klai@163.com.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101903'] 3455,32128884,"Explorative randomized controlled study comparing soft tissue thickness, contour changes, and soft tissue handling of two ridge preservation techniques and spontaneous healing two months after tooth extraction.","OBJECTIVES To compare two ridge preservation techniques and spontaneous healing in terms of soft tissue thickness, contour changes, and soft tissue handling two months after tooth extraction. METHODS Thirty-six patients were included with buccal bone plate dehiscences of up to 50% after single-tooth extraction in the esthetic zone. They were randomly assigned to receive one of three procedures: a deproteinized bovine bone mineral with 10% collagen (DBBM-C) covered with a collagen matrix (DBBM-C/CM), DBBM-C alone, or spontaneous healing (SH). Two months later, the status of soft tissue healing was assessed, and the thickness of the mucosa was measured at the center of the site. Thereafter, implants were placed and the need for further guided bone regeneration (GBR) to cover exposed implant surfaces was assessed. RESULTS Thirty-six patients were evaluated at the day of implant placement. An invagination of the soft tissues was recorded in 41.7% (n = 12), 53.8% (n = 13), and 90.9% (n = 11) of the sites in groups DBBM-C/CM, DBBM-C, and SH, respectively. The median thickness of the mucosa measured was 3.0 mm in group DBBM-C/CM, 2.1 mm in group DBBM-C, and 1.5 mm in group SH. Additional GBR was necessary in 66.7% (n = 12), 53.8% (n = 13), and 90.9% (n = 11) of the sites in groups DBBM-C/CM, DBBM-C, and SH, respectively. CONCLUSIONS The present explorative study revealed slight tendencies for more favorable soft tissue conditions with less invaginations as well as increased soft tissue volume and thickness in groups having received an alveolar ridge preservation procedure compared to spontaneously healed sites at 8 weeks of healing.",2020,"The median thickness of the mucosa measured 3.0mm in group DBBM-C/CM, 2.1mm in group DBBM-C and 1.5mm in the SH group.","['Thirty-six patients', 'Thirty-six patients were included with buccal bone plate dehiscences of up to 50% after single-tooth extraction in the esthetic zone']","['deproteinized bovine bone mineral with 10% collagen (DBBM-C) covered with a collagen matrix (DBBM-C/CM), DBBM-C alone or spontaneous healing (SH']","['median thickness of the mucosa', 'status of soft tissue healing', 'thickness of the mucosa']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0005971', 'cui_str': 'Bone plate, device (physical object)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]","[{'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",36.0,0.0232549,"The median thickness of the mucosa measured 3.0mm in group DBBM-C/CM, 2.1mm in group DBBM-C and 1.5mm in the SH group.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Bienz', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hyun-Chang', 'Initials': 'HC', 'LastName': 'Lim', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wan Zhen', 'Initials': 'WZ', 'LastName': 'Lee', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13594'] 3456,31892654,"'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: a pilot study.","OBJECTIVES Hunger training (HT) is an intervention designed to teach people to eat according to their hunger by connecting physical symptoms of appetite with glucose levels. HT is most effective for weight loss, and improving eating behaviours when adherence is high. However, adherence is a challenge that should be explored prior to wider dissemination. The aim of this study was to explore participants' experience and self-reported adherence and behaviour change related to HT. DESIGN A qualitative study, nested within a randomised controlled pilot study of two different methods of monitoring glucose during HT. Semistructured interviews were audio-recorded, transcribed verbatim and analysed thematically using a phenomenological approach. SETTING Single-centre study with participants recruited from the local area. PARTICIPANTS 40 participants began the pilot study and 38 participants (52.6% women) remained at 1 month and completed interviews. RESULTS Most participants felt they were able to match their hunger to their glucose levels by the end of the intervention. The main adherence barriers were the social pressure to eat, lack of time and lack of flexibility in participants' meal schedules. Common adherence enablers were having a set routine, social support and accountability. Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency. CONCLUSIONS Findings show that HT is acceptable from a patient perspective, and results can be used to inform the translation of HT programme to healthcare settings. TRIAL REGISTRATION NUMBER ACTRN12618001257257.",2019,"Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency. ","[""patients' experience, adherence and behaviour change during hunger training"", 'Single-centre study with participants recruited from the local area', '40 participants began the pilot study and 38 participants (52.6% women) remained at 1\u2009month and completed interviews']","['HT', 'Hunger training (HT', 'monitoring glucose during HT']","['awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety', 'social pressure to eat, lack of time and lack of flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.054161,"Participants described increased awareness of hungry versus non-hungry eating and better cognition of feelings of hunger and satiety as a result of the intervention, which in turn led to changes of food choice, portion size and adjusted meal timing and frequency. ","[{'ForeName': 'Willemijn E', 'Initials': 'WE', 'LastName': 'de Bruin', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Jospe', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand michelle.jospe@otago.ac.nz.'}]",BMJ open,['10.1136/bmjopen-2019-032248'] 3457,31892657,Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START).,"INTRODUCTION Emergency caesarean section (ECS) qualifies as a psychological trauma, which may result in postnatal post-traumatic stress disorder (PTSD). Maternal PTSD may not only have a significant negative impact on mother-infant interactions, but also on long-term infant development. The partner's mental health may also affect infant development. Evidence-based early interventions to prevent the development of postpartum PTSD in mothers are lacking. Immediately after a traumatic event, memory formation is vulnerable to interference. There is accumulating evidence that a brief behavioural intervention including a visuospatial task may result in a reduction in intrusive memories of the trauma. METHODS AND ANALYSIS This study protocol describes a double-blind multicentre randomised controlled phase III trial testing an early brief maternal intervention including the computer game 'Tetris' on intrusive memories of the ECS trauma (≤1 week) and PTSD symptoms (6 weeks, primary outcome) of 144 women following an ECS. The intervention group will carry out a brief behavioural procedure including playing Tetris. The attention-placebo control group will complete a brief written activity log. Both simple cognitive tasks will be completed within the first 6 hours following traumatic childbirth. The intervention is delivered by midwives/nurses in the maternity unit.The primary outcome will be differences in the presence and severity of maternal PTSD symptoms between the intervention and the attention-placebo control group at 6 weeks post partum. Secondary outcomes will be physiological stress and psychological vulnerability, mother-infant interaction and infant developmental outcomes. Other outcomes will be psychological vulnerability and physiological regulation of the partner and their bonding with the infant, as well as the number of intrusive memories of the event. ETHICS AND DISSEMINATION Ethical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2017-02142). Dissemination of results will occur via national and international conferences, in peer-reviewed journals, public conferences and social media. TRIAL REGISTRATION NUMBER NCT03576586.",2019,"There is accumulating evidence that a brief behavioural intervention including a visuospatial task may result in a reduction in intrusive memories of the trauma. ","['144 women following an ECS', 'mothers following traumatic childbirth and in their infants']","['Emergency caesarean section (ECS) qualifies', 'computer game ']","['intrusive memories of the ECS trauma (≤1\u2009week) and PTSD symptoms', 'presence and severity of maternal PTSD symptoms', 'physiological stress and psychological vulnerability, mother-infant interaction and infant developmental outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449430', 'cui_str': 'Physiological Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}]",144.0,0.298487,"There is accumulating evidence that a brief behavioural intervention including a visuospatial task may result in a reduction in intrusive memories of the trauma. ","[{'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Sandoz', 'Affiliation': 'Institute of Higher Education and Research in Healthcare-IUFRS, University of Lausanne and Lausanne University Hospital, Lausanne, VD, Switzerland.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Deforges', 'Affiliation': 'Institute of Higher Education and Research in Healthcare-IUFRS, University of Lausanne and Lausanne University Hospital, Lausanne, VD, Switzerland.'}, {'ForeName': 'Suzannah', 'Initials': 'S', 'LastName': 'Stuijfzand', 'Affiliation': 'Institute of Higher Education and Research in Healthcare-IUFRS, University of Lausanne and Lausanne University Hospital, Lausanne, VD, Switzerland.'}, {'ForeName': 'Manuella', 'Initials': 'M', 'LastName': 'Epiney', 'Affiliation': 'Department Woman-Child-Adolescent, Geneva University Hospital and University of Geneva, Geneva, GE, Switzerland.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vial', 'Affiliation': 'Obstetrics and Gynecology Service, Woman-Mother-Child Department, Lausanne University Hospital and University of Lausanne, Lausanne, VD, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Sekarski', 'Affiliation': 'Paediatric Cardiology Unit, Woman-Mother-Child Department, Lausanne University Hospital and University of Lausanne, Lausanne, VD, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Messerli-Bürgy', 'Affiliation': 'Clinical Child Psychology & Biological Psychology, University of Fribourg, Fribourg, FR, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Ehlert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Zurich, Zurich, ZH, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Bickle-Graz', 'Affiliation': 'Neonatology Service, Woman-Mother-Child Department, University of Lausanne and Lausanne University Hospital, Lausanne, VD, Switzerland.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Morisod Harari', 'Affiliation': 'Service of Child and Adolescent Psychiatry, Lausanne University Hospital and University of Lausanne, Lausanne, VD, Switzerland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Porcheret', 'Affiliation': 'Turner Institute for Brain and Mental Health, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Schechter', 'Affiliation': 'Service of Child and Adolescent Psychiatry, Lausanne University Hospital and University of Lausanne, Lausanne, VD, Switzerland.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'Centre for Maternal and Child Health Research, School of Health Sciences, City University of London, London, London, UK.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Horsch', 'Affiliation': 'Institute of Higher Education and Research in Healthcare-IUFRS, University of Lausanne and Lausanne University Hospital, Lausanne, VD, Switzerland antje.horsch@chuv.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032469'] 3458,31892661,Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark.,"INTRODUCTION AND AIM Uncontrolled asthma is a global health challenge with substantial impact on quality of life (QoL) and overall healthcare costs. Unrecognised and/or unmanaged comorbidities often contribute to presence of uncontrolled asthma. Abnormalities in breathing pattern are termed dysfunctional breathing and are not only common in asthma but also lead to asthma-like symptoms and reduced QoL, and, in keeping with this, improvement with breathing normalisation. Evidence-based guidelines recommend breathing retraining interventions as an adjuvant treatment in uncontrolled asthma. Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control. Despite anecdotal reports, effectiveness of breathing retraining in patients referred to secondary care with incomplete asthma control has not been formally assessed in a randomised controlled trial (RCT). We aim to investigate the effect of breathing exercises on asthma-related QoL in patients with incomplete asthma control despite specialist care. METHODS AND ANALYSIS This two-armed assessor-blinded multicentre RCT will investigate the effect of physiotherapist-delivered breathing retraining on asthma QoL questionnaire (MiniAQLQ) in addition to usual specialist care, recruiting from seven outpatient departments and one specialised clinic representing all regions of Denmark during 2017-2019. We will include 190 consenting adults with incomplete asthma control, defined as Asthma Control Questionnaire 6-item score ≥0.8. Participants will randomly be allocated to either breathing exercise programme in addition to usual care (BrEX +UC) or UC alone. BrEX compiles three physiotherapy sessions and encouragement to perform home exercise daily. Both groups continue usual secondary care management. Primary outcome is between-group difference in MiniAQLQ at 6 months. Secondary outcomes include patient-reported outcome measures, spirometry and accelerometer. ETHICS AND DISSEMINATION Ethics Committee, Region Zealand (SJ-552) and Danish Data Protection Agency (REG-55-2016) approved the trial. Results will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER NCT03127059; Pre-results.",2019,Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control.,"['seven outpatient departments and one specialised clinic representing all regions of Denmark during 2017-2019', 'patients with incomplete asthma control despite specialist care', 'patients referred to secondary care with incomplete asthma control', 'uncontrolled asthma', 'primary care patients with impaired asthma control', '190 consenting adults with incomplete asthma control, defined as Asthma Control Questionnaire 6-item score ≥0.8', 'patients with incomplete asthma control attending specialist care in Denmark']","['breathing retraining', 'breathing exercises', 'breathing exercise programme in addition to usual care (BrEX +UC) or UC alone', 'physiotherapist-delivered breathing retraining', 'Physiotherapy-based breathing pattern modification interventions', 'breathing retraining interventions']","['MiniAQLQ', 'quality of life (QoL) and overall healthcare costs', 'asthma QoL questionnaire (MiniAQLQ', 'asthma-related quality of life', 'patient-reported outcome measures, spirometry and accelerometer']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",,0.158655,Physiotherapy-based breathing pattern modification interventions incorporating relaxation have been shown to improve asthma-related QoL in primary care patients with impaired asthma control.,"[{'ForeName': 'Karen Hjerrild', 'Initials': 'KH', 'LastName': 'Andreasson', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Naestved, Region Zealand, Denmark khad@regionsjaelland.dk.'}, {'ForeName': 'Søren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Naestved, Region Zealand, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Diseases, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Madsen', 'Affiliation': 'Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sidenius', 'Affiliation': 'Allergy & Lung Clinic, Elsinore, (private specialised clinic), Helsingør, Denmark.'}, {'ForeName': 'Jannie Søndergaard', 'Initials': 'JS', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, and Pulmonary Disease Unit, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Midtjylland, Denmark.'}, {'ForeName': 'Karin Dahl', 'Initials': 'KD', 'LastName': 'Assing', 'Affiliation': 'Department of Respiratory Medicine, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Kirsten Brændholt', 'Initials': 'KB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Respiratory Medicine, Zealand University Hospital Roskilde, Roskilde, Zealand, Denmark.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Porsbjerg', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Primary Care, Department for Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Bodtger', 'Affiliation': 'Department for Regional Health Research, Naestved Hospital, University of Southern Denmark, Naestved, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-032984'] 3459,31087085,The Relationship between Alcohol Craving and Insomnia Symptoms in Alcohol-Dependent Individuals.,"AIM This preliminary investigation evaluated the link between alcohol craving and insomnia in actively drinking patients with alcohol dependence (AD). METHODS We conducted a secondary analysis of data from a clinical trial of treatment-seeking patients with AD who drank heavily (N = 61). The Penn Alcohol Craving Scale (PACS) evaluated alcohol craving, and the Short Sleep Index (SSI) assessed insomnia symptoms. We used linear regression models for baseline cross-sectional assessments. Linear mixed effects regression models evaluated craving scores longitudinally across insomnia groups (+/-), and insomnia scores longitudinally across craving groups(high/low). These longitudinal analyses were conducted separately in those treated with placebo (N = 32) and quetiapine (N = 29). RESULTS The mean (standard deviation) for PACS total score was 15.9 (8.5) and for SSI was 2.1 (2.3). Alcohol craving was associated with the insomnia symptom of difficulty falling asleep (P = 0.03; effect size = -0.7) and with the SSI total score (P = 0.04, effect size = -0.7). In the longitudinal analysis, insomnia+ subjects had consistently higher PACS total scores, relative to the insomnia- group. The PACS score demonstrated significant group × time interactions in both treatment groups. Insomnia+ individuals demonstrated a relatively steeper rate of decline in the craving with quetiapine treatment (P = 0.03). Insomnia- individuals in the placebo group demonstrated a transient reduction in craving until week 8, followed by an increase in scores(P = 0.004). The SSI score did not demonstrate any interactive effect over time across the craving groups in either treatment arm. CONCLUSION Insomnia was associated with higher alcohol craving and quetiapine differentially reduced craving in those with insomnia.",2019,"Alcohol craving was associated with the insomnia symptom of difficulty falling asleep (P = 0.03; effect size = -0.7) and with the SSI total score (P = 0.04, effect size = -0.7).","['Alcohol-Dependent Individuals', 'actively drinking patients with alcohol dependence (AD', 'treatment-seeking patients with AD who drank heavily (N = 61']","['quetiapine', 'placebo']","['PACS total scores', 'PACS total score', 'transient reduction in craving', 'alcohol craving and insomnia', 'PACS score', 'Penn Alcohol Craving Scale (PACS) evaluated alcohol craving, and the Short Sleep Index (SSI) assessed insomnia symptoms', 'insomnia symptom of difficulty falling asleep', 'SSI score', 'Alcohol Craving and Insomnia Symptoms', 'Insomnia', 'SSI total score', 'craving scores', 'Alcohol craving']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia (disorder)'}]",61.0,0.0280218,"Alcohol craving was associated with the insomnia symptom of difficulty falling asleep (P = 0.03; effect size = -0.7) and with the SSI total score (P = 0.04, effect size = -0.7).","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of R & D, Cpl. Michael J. Crescenz VA Medical Center, PA, USA.'}, {'ForeName': 'Alyssa T', 'Initials': 'AT', 'LastName': 'Brooks', 'Affiliation': 'Department of Nursing, National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of R & D, Cpl. Michael J. Crescenz VA Medical Center, PA, USA.'}, {'ForeName': 'Subhajit', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': 'Department of R & D, Cpl. Michael J. Crescenz VA Medical Center, PA, USA.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agz029'] 3460,32139298,"TATTON: a multi-arm, phase Ib trial of osimertinib combined with selumetinib, savolitinib, or durvalumab in EGFR-mutant lung cancer.","BACKGROUND Osimertinib is a potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The multi-arm phase Ib TATTON study (NCT02143466) was designed to assess the safety and tolerability of osimertinib in combination with other targeted therapies: selumetinib (MEK1/2 inhibitor), savolitinib (MET-TKI), or durvalumab [anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody]. PATIENTS AND METHODS Patients with advanced EGFR-mutant non-small-cell lung cancer and disease progression on a prior EGFR-TKI were enrolled and allocated to dose-escalating cohorts combining osimertinib 80 mg orally (p.o.) once a day with selumetinib (25-75 mg p.o. twice a day; continuous or intermittent), savolitinib (600-800 mg p.o. once a day), or durvalumab (3-10 mg/kg intravenous every 2 weeks). RESULTS At data cut-off (28 February 2018), 77 patients were enrolled and received osimertinib plus selumetinib (n = 36), savolitinib (n = 18), or durvalumab (n = 23). Most common adverse events (any grade), occurring in ≥20% of patients across dose groups, were: selumetinib arm-diarrhea (75%), rash (58%), nausea (47%); savolitinib arm-nausea (67%), rash (56%), vomiting (50%); durvalumab arm-rash (48%), vomiting (43%), diarrhea (39%). Dose-limiting toxicities were reported in the selumetinib 25 mg (n = 1), 50 mg (n = 1), and 75 mg (n = 4) continuous-dose groups, savolitinib 600 mg (n = 1) and 800 mg dose groups (n = 2), and durvalumab 10 mg/kg (n = 1) dose group. The objective response rate was 42% (95% confidence interval 26% to 59%), 44% (22% to 69%), and 43% (23% to 66%) in the selumetinib, savolitinib, and durvalumab arms, respectively. CONCLUSION Our results demonstrate the feasibility of combining osimertinib 80 mg with selumetinib or savolitinib at identified tolerable, active doses. A combination of osimertinib with durvalumab was not feasible due to increased reporting of interstitial lung disease. Osimertinib-based combination therapies represent a compelling approach now being further investigated. CLINICAL TRIALS NUMBER NCT02143466.",2020,"The objective response rate was 42% (95% confidence interval 26% to 59%), 44% (22% to 69%), and 43% (23% to 66%) in the selumetinib, savolitinib, and durvalumab arms, respectively. ","['Patients with advanced EGFR-mutant non-small-cell lung cancer and disease progression on a prior EGFR-TKI', 'EGFR-mutant lung cancer', '77 patients were enrolled and received']","['selumetinib', 'osimertinib combined with selumetinib, savolitinib, or durvalumab', 'durvalumab', 'osimertinib plus selumetinib', 'osimertinib 80 mg orally (p.o', 'osimertinib in combination with other targeted therapies: selumetinib (MEK1/2 inhibitor), savolitinib (MET-TKI), or durvalumab']","['diarrhea', 'savolitinib arm-nausea', 'durvalumab arm-rash', 'objective response rate', 'rash', 'safety and tolerability', 'vomiting', 'nausea', 'selumetinib arm-diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C2980074'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3642466'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4058831', 'cui_str': 'osimertinib 80 MG [Tagrisso]'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3642466'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2980074'}]",77.0,0.107837,"The objective response rate was 42% (95% confidence interval 26% to 59%), 44% (22% to 69%), and 43% (23% to 66%) in the selumetinib, savolitinib, and durvalumab arms, respectively. ","[{'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Oxnard', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: geoffrey_oxnard@dfci.harvard.edu.'}, {'ForeName': 'J C-H', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'S-W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Clinical Research Center, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'AstraZeneca R&D, Cambridge, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Thress', 'Affiliation': 'Translational Medicine, Research and Early Development, Oncology R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Translational Medicine, Research and Early Development, Oncology R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vishwanathan', 'Affiliation': 'Clinical Pharmacology and Safety Science, R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ghiorghiu', 'Affiliation': 'AstraZeneca R&D, Cambridge, UK.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Winship Cancer Institute, Atlanta, USA.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.01.013'] 3461,32197996,Outcomes of Small Renal Artery Targets in Patients Treated by Fenestrated-Branched Endovascular Aortic Repair.,"OBJECTIVE The aim was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (RA) during fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS A total of 215 consecutive patients enrolled in a prospective F-BEVAR trial were reviewed. Computed tomography angiography centreline of flow reconstruction was used to measure mean RA diameter. Patients who had at least one <4.0 mm main or accessory RA incorporated by fenestration or directional branch (study group) were compared with patients who had incorporation of two ≥5.0 mm RAs (control group). Endpoints were technical success of RA incorporation, RA rupture and kidney loss, primary and secondary RA patency, RA branch instability and re-interventions, and renal function deterioration. RESULTS Twenty-four patients with 28 <4.0 mm RAs (16 accessory and 12 main RAs) were compared with 144 patients with 288 ≥5.0 mm incorporated RAs. Study group patients were significantly younger than controls (72 ± 8 vs. 75 ± 8 years, p = .04) and more often females (46% vs. 21%, p = .018); there were no differences in cardiovascular risk factors and aneurysm extent. Technical success was 92% for <4.0 mm and 99% for ≥5.0 mm RA incorporation (p = .05). Inadvertent RA rupture occurred in three patients in the study group (13%) and in one (1%) in the control group (p = .009) resulting in kidney loss in two study group patients (8%) and one (1%) control group patient (p = .05). At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively. There were no differences in re-intervention rates and renal function deterioration between the groups. The mean follow up time was 21 ± 14 months. CONCLUSION Incorporation of <4.0 mm RAs during F-BEVAR is associated with lower technical success, higher risk of arterial disruption and kidney loss, and lower patency rates at one year.",2020,"At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively.","['Patients who had at least one <4.0\xa0mm main or accessory RA incorporated by fenestration or directional branch (study group) were compared with patients who had incorporation of two\xa0≥5.0\xa0mm RAs (control group', 'Twenty-four patients with 28\xa0<4.0\xa0mm RAs (16 accessory and 12 main RAs) were compared with 144 patients with 288\xa0≥5.0\xa0mm incorporated RAs', 'patients who had incorporation of a small (<4.0\xa0mm) renal artery (RA) during fenestrated-branched endovascular aortic repair (F-BEVAR', 'Study group patients were significantly younger than controls (72\xa0±', '215 consecutive patients enrolled in a prospective F-BEVAR trial were reviewed', 'Patients Treated by Fenestrated-Branched Endovascular Aortic Repair']",['Computed tomography angiography centreline of flow reconstruction'],"['arterial disruption and kidney loss, and lower patency rates', 'Inadvertent RA rupture', 're-intervention rates and renal function deterioration', 'kidney loss', 'technical success of RA incorporation, RA rupture and kidney loss, primary and secondary RA patency, RA branch instability and re-interventions, and renal function deterioration', 'secondary patency', 'cardiovascular risk factors and aneurysm extent', 'Technical success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0337280', 'cui_str': 'Fenestration - action (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}]",215.0,0.0429941,"At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively.","[{'ForeName': 'Jussi M', 'Initials': 'JM', 'LastName': 'Kärkkäinen', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Emanuel R', 'Initials': 'ER', 'LastName': 'Tenorio', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Keouna', 'Initials': 'K', 'LastName': 'Pather', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bernardo C', 'Initials': 'BC', 'LastName': 'Mendes', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thanila A', 'Initials': 'TA', 'LastName': 'Macedo', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wigham', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Diderrich', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Gustavo S', 'Initials': 'GS', 'LastName': 'Oderich', 'Affiliation': 'Mayo Clinic Aortic Centre, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA. Electronic address: oderich.gustavo@mayo.edu.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.02.015'] 3462,31187126,"Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial.","BACKGROUND Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care. METHODS Patients age 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomly assigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided. RESULTS A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care. CONCLUSION Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.",2020,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","['colorectal cancer screening', '5,386 patients', 'Patients aged 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics']","['outreach intervention with usual care versus usual care alone', 'organized outreach', 'organized outreach using fecal immunochemical tests (FIT']","['FIT completion rate', 'FIT screening', 'effectiveness, costs, and cost-effectiveness', 'Outreach cost', 'screening participation at one year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach', 'CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3661444', 'cui_str': 'Safety-net Clinics'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]",5386.0,0.109557,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","[{'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Ajitha', 'Initials': 'A', 'LastName': 'Mannalithara', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Laleau', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grimes', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'CDC, Atlanta, GA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Ladabaum', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz110'] 3463,32019847,Role of nocturnal light intensity on adaptation to three consecutive night shifts: a counterbalanced crossover study.,"OBJECTIVES To investigate how a standard ceiling mounted light-emitting diode (LED)-based bright light intervention affected alertness and neurobehavioural performance during three consecutive simulated night shifts, and timing of circadian rhythm after the shifts. METHODS Twenty seven participants (20 females, 21.4±2.1 years; mean±SD) worked three consecutive night shifts (23:00-07:00) under a full-spectrum (4000 K) bright light (900 lx) and a standard light (90 lx) condition in a counterbalanced crossover design (separated by 4 weeks). Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift. Salivary dim-light melatonin onset (DLMO) was assessed before and after the shifts. The simulated night shifts were conducted in a laboratory while the participants slept at home. RESULTS Subjective alertness and neurobehavioural performance deteriorated during the night shifts in both light conditions. However, bright light significantly reduced alertness and performance decrements as compared with standard light. For a subset of the participants, DLMO was delayed by a mean of 3:17±0:23 (mean±SEM) hours after three night shifts in bright light and by 2:06±0:15 hours in standard light, indicating that bright light causes larger phase delay. CONCLUSION Bright light improved performance and alertness during simulated night shifts and improved adaptation to night work. Bright light administered by ceiling mounted LED luminaires has the potential to improve adaptation to night work and reduce the risk of accidents and injuries among night workers. TRIAL REGISTRATION NUMBER NCT03203538.",2020,Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift.,"['Twenty seven participants (20 females, 21.4±2.1 years; mean±SD) worked three consecutive night shifts (23:00-07:00) under a']","['nocturnal light intensity', 'standard ceiling mounted light-emitting diode (LED)-based bright light intervention', 'full-spectrum (4000 K) bright light (900\u2009lx) and a standard light (90\u2009lx) condition']","['Salivary dim-light melatonin onset (DLMO', 'alertness and neurobehavioural performance', 'alertness and performance decrements', 'Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test', 'performance and alertness']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3876417', 'cui_str': 'Ceiling mount (physical object)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C1532530', 'cui_str': 'Full spectrum'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",27.0,0.0184987,Subjective alertness (Karolinska Sleepiness Scale) and neurobehavioural performance (Psychomotor Vigilance Task and Digit Symbol Substitution Test) were assessed five times during each shift.,"[{'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Sunde', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway erlend.sunde@uib.no.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Mrdalj', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Torhild', 'Initials': 'T', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Eirunn', 'Initials': 'E', 'LastName': 'Thun', 'Affiliation': 'Department of Clinical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Bjorvatn', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Waage', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}]",Occupational and environmental medicine,['10.1136/oemed-2019-106049'] 3464,32154610,EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid Tumors.,"On March 28, 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the marketing authorization for the medicinal product plerixafor. The marketing authorization holder for this medicinal product is Genzyme Europe B.Th. The adoption was for an extension of the existing adult indication in combination with granulocyte colony-stimulating factor (G-CSF) to pediatric patients (aged 1 year to <18 years) to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumors. This treatment is indicated either preemptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regard to desired hematopoietic stem cells yield, or in children who previously failed to collect sufficient hematopoietic stem cells. The efficacy and safety of plerixafor were evaluated in an open label, multicenter, phase I/II, dose-ranging, and randomized controlled study (DFI12860) in pediatric patients with solid tumors, including neuroblastoma, sarcoma, Ewing sarcoma, or lymphoma, who were eligible for autologous hematopoietic stem cell transplantation. Forty-five patients (aged 1 year to <18 years) were randomized, 2:1, using 0.24 mg/kg of plerixafor plus standard mobilization (G-CSF with or without chemotherapy) versus control (standard mobilization alone). The primary analysis showed that 80% of patients in the plerixafor arm experienced at least a doubling of the peripheral blood (PB) CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus 28.6% of patients in the control arm (p = .0019). The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm. The observed safety profile in the pediatric population was consistent with that in adults, with adverse events mainly related to injection site reactions, hypokalemia, and increased blood bicarbonate. Importantly, plerixafor exposure did not seem to negatively affect transplant efficiency. This article summarizes the scientific review of the application leading to regulatory approval in the European Union. IMPLICATIONS FOR PRACTICE: This review of the marketing authorization of plerixafor will raise awareness of pediatric indication granted for this medicinal product.",2020,The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm.,"['children with lymphoma or solid malignant tumors', 'Children with Lymphoma or Malignant Solid Tumors', 'Forty-five patients (aged 1 year to <18\u2009years', 'pediatric patients with solid tumors, including neuroblastoma, sarcoma, Ewing sarcoma, or lymphoma, who were eligible for autologous hematopoietic stem cell transplantation', 'pediatric patients (aged 1 year to <18\u2009years']","['plerixafor', 'plerixafor plus standard mobilization (G-CSF with or without chemotherapy) versus control (standard mobilization alone', 'granulocyte colony-stimulating factor (G-CSF', 'Plerixafor (Mozobil']","['blood bicarbonate', 'peripheral blood (PB) CD34+ count', 'transplant efficiency', 'efficacy and safety', 'PB CD34+ cell counts']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}, {'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1879513', 'cui_str': 'Mozobil'}]","[{'cui': 'C0853263', 'cui_str': 'Blood bicarbonate'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}]",,0.0430409,The median increase in PB CD34+ cell counts from baseline to the day of apheresis was 3.2-fold in the plerixafor arm versus by 1.4-fold in the control arm.,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Karres', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Paula B', 'Initials': 'PB', 'LastName': 'van Hennik', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Straus', 'Affiliation': 'Pharmacovigilance Risk Assessment Committee (PRAC), Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Josephson', 'Affiliation': 'Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.'}, {'ForeName': 'Geanne', 'Initials': 'G', 'LastName': 'Thole', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Glerum', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Herberts', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Babae', 'Affiliation': 'Medicines Evaluation Board, Utrecht, The Netherlands.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Herold', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Papadouli', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0898'] 3465,32142514,mHealth smoking cessation intervention among high school students: 3-month primary outcome findings from a randomized controlled trial.,"BACKGROUND Smoking among adolescents remains a global public health issue as youth continue to maintain high prevalence rates. The evidence for the efficacy of text messaging interventions to reduce smoking behavior is well established, yet there is still a need for studies targeting high school students. The aim of the study was to determine the effectiveness of a text-based smoking cessation intervention among high school students in Sweden. METHODS The study was a two-arm randomized trial conducted from January 10 2018 to January 11 2019, data were analysed from April 12 2019 to May 21 2019. Inclusion criteria were high school students who were daily or weekly smokers willing to attempt to quit smoking and owned a mobile phone. The study invited all students at 630 high schools units throughout Sweden. The intervention group received text messages based on components of effective smoking cessation interventions for 12 weeks. The control group were offered treatment as usual. The primary outcomes were self-reported prolonged abstinence (not having smoked more than 5 cigarettes over the last 8 weeks) and 4-week point prevalence of smoking abstinence. FINDINGS A total of 535 participants, with a median age of 17 (IQR 16-18), were randomized into the study; 276 (164 [59.4%] women) were allocated to the intervention and 259 (162 [62.5%] women) to the control group. The outcomes of the trial were analyzed on a total of 212 (76.8%) participants in the intervention group and 201 (77.6%) participants in the control group. Prolonged abstinence at the 3-month follow-up was reported by 49 (23.1%) individuals in the intervention group and 39 (19.4%) individuals in the control group (adjusted OR, 1.21; 95% CI, 0.73-2.01; P value, .46). Four-week point prevalence of complete smoking cessation was reported by 53 (25.0%) individuals in the intervention group and 31 (15.4%) individuals in the control group (adjusted OR, 1.87; 95% CI, 1.12-3.17; P value, .018). CONCLUSIONS Estimates of 4-week point prevalence of complete cessation was 10 percentage points higher in the group that were given access to the intervention compared to the control. Findings provide confirmation that text messaging-based smoking cessation programs can affect quit rates among adolescents. TRIAL REGISTRATION ISRCTN15396225; registration date October 13, 2017, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3028-2.",2020,"Four-week point prevalence of complete smoking cessation was reported by 53 (25.0%) individuals in the intervention group and 31 (15.4%) individuals in the control group (adjusted OR, 1.87; 95% CI, 1.12-3.17; P value, .018). ","['535 participants, with a median age of 17 (IQR 16-18), were randomized into the study; 276', 'from January 10 2018 to January 11 2019, data were analysed from April 12 2019 to May 21 2019', '212 (76.8%) participants in the intervention group and 201 (77.6%) participants in the control group', 'high school students', 'adolescents', 'The study invited all students at 630 high schools units throughout Sweden', 'Inclusion criteria were high school students who were daily or weekly smokers willing to attempt to quit smoking and owned a mobile phone', 'high school students in Sweden']","['text messaging interventions', 'text-based smoking cessation intervention', 'mHealth smoking cessation intervention', 'text messages based on components of effective smoking cessation interventions']","['Prolonged abstinence', 'quit rates', 'complete smoking cessation', 'self-reported prolonged abstinence', '4-week point prevalence of smoking abstinence']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",535.0,0.0923726,"Four-week point prevalence of complete smoking cessation was reported by 53 (25.0%) individuals in the intervention group and 31 (15.4%) individuals in the control group (adjusted OR, 1.87; 95% CI, 1.12-3.17; P value, .018). ","[{'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Müssener', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Faculty of Medicine and Health, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Linderoth', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Faculty of Medicine and Health, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Faculty of Medicine and Health, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Faculty of Medicine and Health, Linköping University, Linköping, Sweden.'}]",PloS one,['10.1371/journal.pone.0229411'] 3466,31494443,"The relative importance of perceived substance misuse use by different peers on smoking, alcohol and illicit drug use in adolescence.","BACKGROUND Substance use by young people is strongly associated with that of their peers. Little is known about the influence of different types of peers. We tested the relationship between perceived substance use by five types of peers and adolescents' use of illicit drugs, smoking, and alcohol consumption. METHODS We used data collected from 1285 students aged 12-13 as part of a pilot cluster randomized controlled trial (United Kingdom, 2014-2016). The exposures were the perceived use of illicit drugs, smoking and alcohol consumption by best friends, boy or girlfriends, brothers or sisters, friends outside of school and online. Outcomes were self-reported lifetime use of illicit drugs, smoking and alcohol consumption assessed 18-months later. RESULTS The lifetime prevalence of illicit drug use, smoking and alcohol consumption at the 18-month follow-up were 14.3%, 24.9% and 54.1%, respectively. In the fully adjusted models, perceived substance use by friends outside of school, brothers or sisters, and online had the most consistent associations with outcomes. Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). CONCLUSIONS Perceived substance use by friends outside of school, brothers and sisters and online could be viable sources of peer influence. If these findings are replicated, a greater emphasis should be made in interventions to mitigate the influence of these peers.",2019,"Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). ","['1285 students aged 12-13\u202fas part of a pilot cluster randomized controlled trial (United Kingdom, 2014-2016']",[],"['alcohol consumption', 'risk of ever having used illicit drugs', 'lifetime prevalence of illicit drug use, smoking and alcohol consumption', 'self-reported lifetime use of illicit drugs, smoking and alcohol consumption assessed 18-months later']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.049883,"Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). ","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Er', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom. Electronic address: Vanessa.Er@lshtm.ac.uk.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol. Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom. Electronic address: Rona.Campbell@bristol.ac.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hickman', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol. Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, United Kingdom. Electronic address: Matthew.Hickman@bristol.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, United Kingdom. Electronic address: Chris.Bonell@lshtm.ac.uk.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow, G2 3QB, United Kingdom. Electronic address: Laurence.Moore@glasgow.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, 4th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, United Kingdom. Electronic address: WhiteJ11@cardiff.ac.uk.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.04.035'] 3467,31501081,Supremacy of Auditory Versus Visual Input in Somatic Empathy and Perceived Pain Level.,"BACKGROUND Previous studies support the role of both auditory and visual stimuli in the evocation of empathy, but no research to date has explored the relative effectiveness of each on any type of empathy. AIMS The present study compared how auditory and visual presentation influence somatic empathic arousal and perceived pain level. DESIGN Exposure to auditory and/or visual information about an individual in pain was manipulated between groups of participants. METHODS Students (N = 125) in several classes were randomly assigned in groups to one of three conditions-audio-only, video-only, or audio-video-each portraying an elderly man suffering from a painful kidney stone. Participants indicated his perceived pain and level of danger and relevant physical sensations and completed an empathy status scale. RESULTS Consistent with the hypothesis, the results indicated that participants who were presented with an auditory stimulus (audio-only and audio-video conditions) estimated higher and more accurate pain and danger level for the patient compared with those in the visual-only group. Participants in the audio groups also reported experiencing physical sensations, whereas the visual-only group had no such report. CONCLUSIONS The study found that auditory information is more impactful in eliciting perceptions of pain in others compared with visual information. Experiences of clinical empathy and patient care may be improved by focusing on patients' auditory pain communications.",2020,"Participants in the audio groups also reported experiencing physical sensations, whereas the visual-only group had no such report. ","['Students (N\xa0=\xa0125) in several classes', 'an elderly man suffering from a painful kidney stone']","['three conditions-audio-only, video-only, or audio-video-each portraying']","['his perceived pain and level of danger and relevant physical sensations and completed an empathy status scale', 'experiencing physical sensations', 'accurate pain and danger level', 'Supremacy of Auditory Versus Visual Input in Somatic Empathy and Perceived Pain Level']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0694991,"Participants in the audio groups also reported experiencing physical sensations, whereas the visual-only group had no such report. ","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Agahi', 'Affiliation': 'University of San Diego, San Diego, California. Electronic address: Sagahi@sandiego.edu.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Wanic', 'Affiliation': 'University of San Diego, San Diego, California.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2019.06.013'] 3468,31549622,A bespoke smoking cessation service compared with treatment as usual for people with severe mental ill health: the SCIMITAR+ RCT.,"BACKGROUND There is a high prevalence of smoking among people with severe mental ill health (SMI). Helping people with SMI to quit smoking could improve their health and longevity, and reduce health inequalities. However, those with SMI are less likely to access and engage with routine smoking cessation services than the general population. OBJECTIVES To compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual stop smoking services for people with SMI. DESIGN A pragmatic, two-arm, individually randomised controlled trial. SETTING Primary care and secondary care mental health services in England. PARTICIPANTS Smokers aged ≥ 18 years with SMI who would like to cut down on or quit smoking. INTERVENTIONS A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual care. MAIN OUTCOME MEASURES The primary outcome was self-reported, CO-verified smoking cessation at 12 months. Smoking-related secondary outcomes were self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire. Other secondary outcomes were Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index measured at 6 and 12 months post randomisation. RESULTS The trial randomised 526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years). About 60% of participants were male. Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline. The intervention group had a higher rate of exhaled CO-verified smoking cessation at 6 and 12 months than the usual-care group [adjusted odds ratio (OR) 12 months: 1.6, 95% confidence interval (CI) 0.9 to 2.8; adjusted OR 6 months: 2.4, 95% CI 1.2 to 4.7]. This was not statistically significant at 12 months ( p  = 0.12) but was statistically significant at 6 months ( p  = 0.01). In total, 111 serious adverse events were reported (69 in the BSC group and 42 in the usual-care group); the majority were unplanned hospitalisations due to a deterioration in mental health ( n  = 98). The intervention is likely (57%) to be less costly but more effective than usual care; however, this result was not necessarily associated with participants' smoking status. LIMITATIONS Follow-up was not blind to treatment allocation. However, the primary outcome included a biochemically verified end point, less susceptible to observer biases. Some participants experienced difficulties in accessing nicotine replacement therapy because of changes in service provision. Efforts were made to help participants access nicotine replacement therapy, but this may have affected participants' quit attempt. CONCLUSIONS People with SMI who received the intervention were more likely to have stopped smoking at 6 months. Although more people who received the intervention had stopped smoking at 12 months, this was not statistically significant. FUTURE WORK Further research is needed to establish how quitting can be sustained among people with SMI. TRIAL REGISTRATION Current Controlled Trials ISRCTN72955454. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 50. See the NIHR Journals Library website for further project information.",2019,This was not statistically significant at 12 months ( p  = 0.12) but was statistically significant at 6 months ( p  = 0.01).,"['People with SMI', '526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years', 'people with severe mental ill health (SMI', 'Primary care and secondary care mental health services in England', 'people with severe mental ill health', 'Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline', 'people with SMI', 'Smokers aged ≥\u200918 years with SMI who would like to cut down on or quit smoking']","['nicotine replacement therapy', 'bespoke smoking cessation (BSC) intervention with usual stop smoking services']","['Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index', 'self-reported, CO-verified smoking cessation', 'self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire', 'rate of exhaled CO-verified smoking cessation', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",526.0,0.102674,This was not statistically significant at 12 months ( p  = 0.12) but was statistically significant at 6 months ( p  = 0.01).,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Bradshaw', 'Affiliation': 'Centre for Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Horspool', 'Affiliation': 'Research and Development, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Research and Development, Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Ker', 'Affiliation': 'North East York Community Mental Health Team, Tees, Esk and Wear Valleys NHS Foundation Trust, York, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Leahy', 'Affiliation': 'Research and Development, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Tayla', 'Initials': 'T', 'LastName': 'McCloud', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Reilly', 'Affiliation': 'North East York Community Mental Health Team, Tees, Esk and Wear Valleys NHS Foundation Trust, York, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steare', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ballantyne', 'Affiliation': 'Research and Development, Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Bidwell', 'Affiliation': 'Research and Development, Lancashire Care NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': 'Research and Development, Tees, Esk and Wear Valleys NHS Foundation Trust, Stockton on Tees, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Research and Development, Lincolnshire Partnership NHS Foundation Trust, Sleaford, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Callen', 'Affiliation': 'Research and Development, Solent NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carey', 'Affiliation': 'Research and Development, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Colbeck', 'Affiliation': 'Research and Development, Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Coton', 'Affiliation': 'Research and Development, Sussex Partnership NHS Foundation Trust, Hove, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Donaldson', 'Affiliation': 'Research and Development, Berkshire Healthcare NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'Research and Development, Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Herlihy', 'Affiliation': 'Research and Development, Kent and Medway NHS and Social Care Partnership Trust, Maidstone, UK.'}, {'ForeName': 'Wajid', 'Initials': 'W', 'LastName': 'Khan', 'Affiliation': 'Research and Development, South West Yorkshire Partnership NHS Foundation Trust, Wakefield, UK.'}, {'ForeName': 'Lizwi', 'Initials': 'L', 'LastName': 'Nyathi', 'Affiliation': 'Research and Development, Lincolnshire Partnership NHS Foundation Trust, Sleaford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nyamadzawo', 'Affiliation': 'Research and Development, Bradford District Care NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Oldknow', 'Affiliation': 'Research and Development, Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Research and Development, Southern Health NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rea', 'Affiliation': 'Research and Development, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Crystal-Bella', 'Initials': 'CB', 'LastName': 'Romain-Hooper', 'Affiliation': 'Research and Development, Leeds and York Partnership NHS Foundation Trust, Leeds, UK.'}, {'ForeName': 'Kaye', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Research and Development, Solent NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Stribling', 'Affiliation': 'Research and Development, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Carinna', 'Initials': 'C', 'LastName': 'Vickers', 'Affiliation': 'Research and Development, Somerset Partnership NHS Foundation Trust, South Petherton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23500'] 3469,32087610,Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability.,"A common setting where depression is identified and treated is in primary care, where there is a need for low-intensity and cost-effective interventions to be used as part of a stepped-care model. The current study involved a pilot, parallel-group, randomized controlled trial of a video self-help intervention for primary care patients based on acceptance and commitment therapy (ACT). The intervention, called LifeStories, consisted of storytelling vignettes of patients describing their use of ACT-consistent coping skills for depression. Primary care patients were recruited to determine feasibility, acceptability, and potential clinical effects of the intervention. Twenty-one participants were assigned to use LifeStories over a period of 4 weeks, and 19 participants were assigned to an attention-matched comparison group. Qualitative feedback indicated that participants using LifeStories found the intervention to be engaging and useful in transmitting key ACT principles. Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group. Both conditions showed large improvements in levels of depression at a 12-week follow-up. There were no significant differences in symptom outcomes between groups; however, because this was a pilot study, it was not powered to detect differences between interventions. Both conditions additionally showed smaller effect size changes in psychological flexibility, a key ACT mechanism. The results suggest LifeStories to be a feasible and acceptable psychological intervention that may improve depression, and further research is warranted to determine its effectiveness as part of a stepped-care approach to treating depression in primary care.",2020,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","['A total of 21 participants', 'Primary care patients', 'primary care patients based on Acceptance and Commitment Therapy (ACT']","['ACT-consistent coping skills', 'Video Self-Help Intervention', 'video self-help intervention']","['symptom outcomes', 'psychological flexibility', 'levels of depression']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",21.0,0.0716519,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Carter H', 'Initials': 'CH', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Utah State University, Logan, Utah.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Uebelacker', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2436'] 3470,31856942,Guided self-help for depression in autistic adults: the ADEPT feasibility RCT.,"BACKGROUND Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive-behavioural therapy for depression. To the authors' knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive-behavioural therapy for depression in autism. OBJECTIVES The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial. DESIGN The study comprised a randomised controlled trial ( n  = 70) with a nested qualitative evaluation ( n  = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual. SETTING Adult autism services in two NHS regions. PARTICIPANTS Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded. INTERVENTIONS The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression. MAIN OUTCOME MEASURES Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori. RESULTS The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses. CONCLUSIONS The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted. FUTURE WORK Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure. TRIAL REGISTRATION Current Controlled Trials ISRCTN54650760. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.",2019,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","['Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥\u200910', 'autistic adults', 'n \u2009=\u200970) with a nested qualitative evaluation ( n \u2009=\u200921', 'Adult autism services in two NHS regions', 'People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded', 'Seventy eligible and consenting participants']","['low-intensity cognitive-behavioural therapy', 'guided self-help or to treatment as usual', 'low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision', 'low-intensity psychological intervention']","['self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire', 'differential rates of attrition', 'depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",70.0,0.116336,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Newcastle Cognitive and Behavioural Therapies Centre, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'BASS Adult Autism Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Parr', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23680'] 3471,31059641,Targeting Huntingtin Expression in Patients with Huntington's Disease.,"BACKGROUND Huntington's disease is an autosomal-dominant neurodegenerative disease caused by CAG trinucleotide repeat expansion in HTT , resulting in a mutant huntingtin protein. IONIS-HTT Rx (hereafter, HTT Rx ) is an antisense oligonucleotide designed to inhibit HTT messenger RNA and thereby reduce concentrations of mutant huntingtin. METHODS We conducted a randomized, double-blind, multiple-ascending-dose, phase 1-2a trial involving adults with early Huntington's disease. Patients were randomly assigned in a 3:1 ratio to receive HTT Rx or placebo as a bolus intrathecal administration every 4 weeks for four doses. Dose selection was guided by a preclinical model in mice and nonhuman primates that related dose level to reduction in the concentration of huntingtin. The primary end point was safety. The secondary end point was HTT Rx pharmacokinetics in cerebrospinal fluid (CSF). Prespecified exploratory end points included the concentration of mutant huntingtin in CSF. RESULTS Of the 46 patients who were enrolled in the trial, 34 were randomly assigned to receive HTT Rx (at ascending dose levels of 10 to 120 mg) and 12 were randomly assigned to receive placebo. Each patient received all four doses and completed the trial. Adverse events, all of grade 1 or 2, were reported in 98% of the patients. No serious adverse events were seen in HTT Rx -treated patients. There were no clinically relevant adverse changes in laboratory variables. Predose (trough) concentrations of HTT Rx in CSF showed dose dependence up to doses of 60 mg. HTT Rx treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx 10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively). CONCLUSIONS Intrathecal administration of HTT Rx to patients with early Huntington's disease was not accompanied by serious adverse events. We observed dose-dependent reductions in concentrations of mutant huntingtin. (Funded by Ionis Pharmaceuticals and F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT02519036.).",2019,"HTT Rx treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx 10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively). ","[""Patients with Huntington's Disease"", ""adults with early Huntington's disease"", '46 patients who were enrolled in the trial']","['HTT Rx or placebo', 'placebo', 'HTT Rx']","['Adverse events', 'HTT Rx pharmacokinetics in cerebrospinal fluid (CSF', 'concentration of mutant huntingtin in CSF', 'serious adverse events', 'concentrations of mutant huntingtin', 'Predose (trough) concentrations of HTT Rx']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020179', 'cui_str': 'Progressive Chorea, Hereditary, Chronic (Huntington)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007807'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",34.0,0.262503,"HTT Rx treatment resulted in a dose-dependent reduction in the concentration of mutant huntingtin in CSF (mean percentage change from baseline, 10% in the placebo group and -20%, -25%, -28%, -42%, and -38% in the HTT Rx 10-mg, 30-mg, 60-mg, 90-mg, and 120-mg dose groups, respectively). ","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Tabrizi', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Blair R', 'Initials': 'BR', 'LastName': 'Leavitt', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'G Bernhard', 'Initials': 'GB', 'LastName': 'Landwehrmeyer', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Wild', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Saft', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Nick F', 'Initials': 'NF', 'LastName': 'Blair', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Craufurd', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Priller', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Rickards', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Holly B', 'Initials': 'HB', 'LastName': 'Kordasiewicz', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Czech', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Swayze', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Norris', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Baumann', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gerlach', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Schobel', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Paz', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Smith', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'C Frank', 'Initials': 'CF', 'LastName': 'Bennett', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': 'Roger M', 'Initials': 'RM', 'LastName': 'Lane', 'Affiliation': ""From University College London (UCL) Huntington's Disease Centre, Department of Neurodegenerative Disease, Queen Square Institute of Neurology, UCL, and the U.K. Dementia Research Institute at UCL, London (S.J.T., E.J.W.), the Department of Clinical Neuroscience, Addenbrooke's Hospital, University of Cambridge, Cambridge (R.A.B., N.F.B.), Manchester Centre for Genomic Medicine, St. Mary's Hospital, Manchester University NHS Foundation Trust, and the Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester (D.C.), the University of Edinburgh and the U.K. Dementia Research Institute, Edinburgh (J.P.), the Institute of Clinical Sciences, College of Medical and Dental Sciences, University Hospital Birmingham, Birmingham (H.R.), and the Cardiff University Brain Repair Group, Brain Repair and Intracranial Neurotherapeutics Unit, Neuroscience and Mental Health Research Institute and School of Biosciences, Cardiff (A.R.) - all in the United Kingdom; the Centre for Huntington's Disease, Department of Medical Genetics, and the Division of Neurology, Department of Medicine, University of British Columbia, and the Centre for Molecular Medicine and Therapeutics, B.C. Children's Hospital, Vancouver, Canada (B.R.L.); the Department of Neurology, Ulm University, Huntington's Disease Centre, Ulm (G.B.L.), the Department of Neurology, Huntington Center North Rhine-Westphalia, Ruhr University Bochum, St. Josef-Hospital, Bochum (C.S.), and the Department of Neuropsychiatry, Charité-Universitätsmedizin Berlin, Deutsches Zentrum für Neurodegenerative Erkrankungen, Berlin (J.P.) - all in Germany; Ionis Pharmaceuticals, Carlsbad, CA (H.B.K., E.E.S., D.A.N., T.B., E.P., A.V.S., C.F.B., R.M.L.); and F. Hoffmann-La Roche, Basel, Switzerland (C.C., I.G., S.A.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900907'] 3472,31812184,Efficacy of the Enquiring About Tolerance (EAT) study among infants at high risk of developing food allergy.,"BACKGROUND The Enquiring About Tolerance (EAT) study was a randomized trial of the early introduction of allergenic solids into the infant diet from 3 months of age. The intervention effect did not reach statistical significance in the intention-to-treat analysis of the primary outcome. OBJECTIVE We sought to determine whether infants at high risk of developing a food allergy benefited from early introduction. METHODS A secondary intention-to-treat analysis was performed of 3 groups: nonwhite infants; infants with visible eczema at enrollment, with severity determined by SCORAD; and infants with enrollment food sensitization (specific IgE ≥0.1 kU/L). RESULTS Among infants with sensitization to 1 or more foods at enrollment (≥0.1 kU/L), early introduction group (EIG) infants developed significantly less food allergy to 1 or more foods than standard introduction group (SIG) infants (SIG, 34.2%; EIG, 19.2%; P = .03), and among infants with sensitization to egg at enrollment, EIG infants developed less egg allergy (SIG, 48.6%; EIG, 20.0%; P = .01). Similarly, among infants with moderate SCORAD (15-<40) at enrollment, EIG infants developed significantly less food allergy to 1 or more foods (SIG, 46.7%; EIG, 22.6%; P = .048) and less egg allergy (SIG, 43.3%; EIG, 16.1%; P = .02). CONCLUSION Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment. This efficacy occurred despite low adherence to the early introduction regimen. This has significant implications for the new national infant feeding recommendations that are emerging around the world.",2019,Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment.,"['infant diet from 3\xa0months of age', 'A secondary intention-to-treat analysis was performed of 3 groups: nonwhite infants; infants with visible eczema at enrollment, with severity determined by SCORAD; and infants with enrollment food sensitization (specific IgE ≥0.1 kU/L', 'infants at high risk of developing food allergy', 'infants at high risk of developing a food allergy benefited from early introduction']",['Enquiring About Tolerance (EAT'],"['food allergy to 1 or more foods', 'egg allergy', 'food allergy']","[{'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0559469', 'cui_str': 'Egg Hypersensitivity'}]",,0.19238,Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment.,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Bahnson', 'Affiliation': 'Benaroya Research Institute, Seattle, Wash.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, Faculty of Life Sciences & Medicine, King's College, London, United Kingdom.""}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Mills', 'Affiliation': 'School of Biological Sciences, Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, Manchester Institute of Biotechnology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Versteeg', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Ree', 'Affiliation': 'Department of Experimental Immunology, Academic Medical Center, Amsterdam, The Netherlands; Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Research Group, Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom. Electronic address: gideon.lack@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.06.045'] 3473,31201188,"Six versus two weeks treatment with doxycycline in Lyme neuroborreliosis: the protocol of a multicentre, non-inferiority, double-blinded and randomised controlled trial.","INTRODUCTION Current treatment guidelines for European Lyme neuroborreliosis (LNB) recommend cephalosporins, penicillin or doxycycline for 14-28 days but evidence for optimal treatment length is poor. Treatment lengths in clinical practice tend to exceed the recommendations. Most patients experience a rapid improvement of symptoms and neurological findings within days of treatment, but some report long-term complaints. The underlying mechanisms of remaining complaints are debated, and theories as ongoing chronic infection with Borrelia burgdorferi , dysregulated immune responses, genetic predisposition, coinfection with multiple tick-borne pathogens, structural changes in CNS and personal traits have been suggested. The main purpose of our trial is to address the hypothesis of improved outcome after long-term antibiotic treatment of LNB, by comparing efficacy of treatment with 2 and 6 weeks courses of doxycycline. METHODS AND ANALYSIS The trial has a multicentre, non-inferiority, double-blinded design. One hundred and twenty patients diagnosed with LNB according to European Federation of Neurological Societies (EFNS)guidelines will be randomised to 6 or 2 weeks treatment with oral doxycycline. The patients will be followed for 12 months. The primary endpoint is improvement on a composite clinical score (CCS) from baseline to 6 months after inclusion. Secondary endpoints are improvements in the CCS 12 months after inclusion, fatigue scored on Fatigue Severity Scale, subjective symptoms on the Patient Health Questionnaire-15 scale, health-related quality of life scored on RAND 36-item short form health survey and safety as measured by side effects of the two treatment arms. Blood and cerebrospinal fluid (CSF) are collected from inclusion and throughout the follow-up and a biobank will be established. The study started including patients in November 2015 and will continue throughout December 2019. ETHICS AND DISSEMINATION The study is approved by the Norwegian regional committees for medical and health research ethics and the Norwegian Medicines Agency. Data from the study will be published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER 2015-001481-25.",2019,"Secondary endpoints are improvements in the CCS 12 months after inclusion, fatigue scored on Fatigue Severity Scale, subjective symptoms on the Patient Health Questionnaire-15 scale, health-related quality of life scored on RAND 36-item short form health survey and safety as measured by side effects of the two treatment arms.","['patients in November 2015 and will continue throughout December 2019', 'One hundred and twenty patients diagnosed with LNB according to European Federation of Neurological Societies (EFNS)guidelines']","['oral doxycycline', 'cephalosporins, penicillin or doxycycline', 'doxycycline']","['Blood and cerebrospinal fluid (CSF', 'composite clinical score (CCS', 'CCS 12 months after inclusion, fatigue scored on Fatigue Severity Scale, subjective symptoms on the Patient Health Questionnaire-15 scale, health-related quality of life scored on RAND 36-item short form health survey and safety as measured by side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}]","[{'cui': 'C0005768'}, {'cui': 'C0007807'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",120.0,0.402006,"Secondary endpoints are improvements in the CCS 12 months after inclusion, fatigue scored on Fatigue Severity Scale, subjective symptoms on the Patient Health Questionnaire-15 scale, health-related quality of life scored on RAND 36-item short form health survey and safety as measured by side effects of the two treatment arms.","[{'ForeName': 'Anne Marit', 'Initials': 'AM', 'LastName': 'Solheim', 'Affiliation': 'Department of Neurology, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Unn', 'Initials': 'U', 'LastName': 'Ljøstad', 'Affiliation': 'Department of Neurology, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Mygland', 'Affiliation': 'Department of Neurology, Sørlandet Hospital, Kristiansand, Norway.'}]",BMJ open,['10.1136/bmjopen-2018-027083'] 3474,31577219,Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT.,"BACKGROUND Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications. Improvements in endoscopic equipment and training have made laparoscopic supracervical hysterectomy (LASH) accessible to most gynaecologists. This operation could preserve the advantages of total hysterectomy and reduce the risk of complications. OBJECTIVES To compare the clinical effectiveness and cost-effectiveness of LASH with second-generation EA in women with HMB. DESIGN A parallel-group, multicentre, randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Surgeons and participants were not blinded to the allocated procedure. SETTING Thirty-one UK secondary and tertiary hospitals. PARTICIPANTS Women aged < 50 years with HMB. Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size > 11 cm; any fibroids > 3 cm; contraindications to laparoscopic surgery; previous EA; and inability to give informed consent or complete trial paperwork. INTERVENTIONS LASH compared with second-generation EA. MAIN OUTCOME MEASURES Co-primary clinical outcome measures were (1) patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score at 15 months post randomisation. The primary economic outcome was incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained. RESULTS A total of 330 participants were randomised to each group (total n  = 660). Women randomised to LASH were more likely to be satisfied with their treatment than those randomised to EA (97.1% vs. 87.1%) [adjusted difference in proportions 0.10, 95% confidence interval (CI) 0.05 to 0.15; adjusted odds ratio (OR) from ordinal logistic regression (OLR) 2.53, 95% CI 1.83 to 3.48; p  < 0.001]. Women randomised to LASH were also more likely to have the best possible MMAS score of 100 (68.7% vs. 54.5%) (adjusted difference in proportions 0.13, 95% CI 0.04 to 0.23; adjusted OR from OLR 1.87, 95% CI 1.31 to 2.67; p  = 0.001). Serious adverse event rates were low and similar in both groups (4.5% vs. 3.6%). There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs. Based on an extrapolation of expected differences in cost and QALYs out to 10 years, LASH cost an additional £1362 for an average QALY gain of 0.11, equating to an incremental cost-effectiveness ratio of £12,314 per QALY. Probabilities of cost-effectiveness were 53%, 71% and 80% at cost-effectiveness thresholds of £13,000, £20,000 and £30,000 per QALY gained, respectively. LIMITATIONS Follow-up data beyond 15 months post randomisation are not available to inform cost-effectiveness. CONCLUSION LASH is superior to EA in terms of clinical effectiveness. EA is less costly in the short term, but expected higher retreatment rates mean that LASH could be considered cost-effective by 10 years post procedure. FUTURE WORK Retreatment rates, satisfaction and quality-of-life scores at 10-year follow-up will help to inform long-term cost-effectiveness. TRIAI REGISTRATION Current Controlled Trials ISRCTN49013893. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 53. See the NIHR Journals Library website for further project information.",2019,"There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs.","['heavy menstrual bleeding', 'women with HMB', 'British women', 'Women aged <\u200950 years with HMB', 'Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size >\u200911\u2009cm; any fibroids >\u20093\u2009cm; contraindications to', '330 participants', 'Thirty-one UK secondary and tertiary hospitals']","['laparoscopic surgery; previous EA', 'Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation', 'LASH', 'LASH with second-generation EA']","['possible MMAS score', 'Serious adverse event rates', 'hospital stay', 'incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained', 'satisfaction and quality-of-life scores', 'patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score', 'Probabilities of cost-effectiveness', 'adjusted mean costs', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}]","[{'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",330.0,0.26408,"There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs.","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Neil W', 'Initials': 'NW', 'LastName': 'Scott', 'Affiliation': 'Medical Statistics Team, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernández', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'T Justin', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Birmingham Women's NHS Foundation Trust, Birmingham Women's Hospital, Birmingham, UK.""}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Hawe', 'Affiliation': 'Countess of Chester Hospital NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawthorn', 'Affiliation': 'NHS Greater Glasgow and Clyde, Southern General Hospital, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Wileman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'McCormack', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23530'] 3475,31288751,Means of increasing response rates in a Norwegian dietary survey among infants - results from a pseudo-randomized pilot study.,"BACKGROUND Postal surveys are widely used in scientific studies, including dietary surveys, but few studies about methods to increase participation in national dietary surveys are published. In the present study we compared response rates in a pilot study to a national dietary survey among infants using two different incentives (gift certificate or lottery), personalization in the form of handwritten name and address vs. a printed label and mode of sending out invitations (e-mail or postal invitation). METHODS In this parallel-design pseudo-randomized pilot trial, a nationally representative sample of 698 mothers of infants aged 6 and 12 months was drawn from the Norwegian National Registry and invited to complete a food frequency questionnaire about their infant's diet. One half of the mothers of 6 month olds were randomized by alternation to the lottery group (n = 198) and offered to participate in a lottery of two prizes (500 EUR and 1000 EUR). The other half (n = 200) was offered a gift certificate (50 EUR) upon completion of the questionnaire. Each incentive group was randomized by alternation to receiving an invitation with handwritten name and address or a printed label. For the mothers of infants aged 12 months (n = 300), 150 mothers received an e-mail invitation and 150 mothers received a postal invitation. Logistic regression was used for testing differences between the groups. RESULTS The response rate was significantly higher (p = 0.028) in the gift certificate group (72%) than in the lottery group (62%). No difference was seen between those receiving an invitation with a handwritten name and address (68%) compared to a printed label (66%, p = 0.72). A somewhat higher response rate was seen when using the postal (50%) compared to the e-mail invitation (43%, p = 0.25). CONCLUSIONS In this pseudo-randomized parallel-design trial of women participating in a national dietary survey among infants, the response rate was higher when offered a gift certificate than when participating in a lottery. Handwritten name and address did not affect participation compared to a printed label. Only a moderate difference was seen between the postal and e-mail invitation. Others conducting similar methodological studies are encouraged to publish their results to expand the knowledge basis in this area.",2019,The response rate was significantly higher (p = 0.028) in the gift certificate group (72%) than in the lottery group (62%).,"['One half of the mothers of 6\u2009month olds', ""nationally representative sample of 698 mothers of infants aged 6 and 12\u2009months was drawn from the Norwegian National Registry and invited to complete a food frequency questionnaire about their infant's diet"", 'infants using two different incentives (gift certificate or lottery), personalization in the form of handwritten name and address vs. a printed label and mode of sending out invitations (e-mail or postal invitation', 'women participating in a national dietary survey among infants, the response rate was higher when offered a gift certificate than when participating in a lottery', 'mothers of infants aged 12\u2009months (n\u2009=\u2009300), 150 mothers received an e-mail invitation and 150 mothers received a postal invitation']",['alternation to receiving an invitation with handwritten name and address or a printed label'],['response rate'],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1136188', 'cui_str': 'Gifts'}, {'cui': 'C0586303', 'cui_str': 'Certificate (record artifact)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0919661', 'cui_str': 'Heart alternation'}, {'cui': 'C0376649', 'cui_str': 'Address'}]",[],,0.046556,The response rate was significantly higher (p = 0.028) in the gift certificate group (72%) than in the lottery group (62%).,"[{'ForeName': 'Jannicke Borch', 'Initials': 'JB', 'LastName': 'Myhre', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway. j.b.myhre@medisin.uio.no.'}, {'ForeName': 'Lene Frost', 'Initials': 'LF', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Holvik', 'Affiliation': 'Department of Chronic Diseases and Aging, Norwegian Institute of Public Health, PO Box 222, Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}, {'ForeName': 'Anne Lene', 'Initials': 'AL', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, PO Box 1046, Blindern, 0317, Oslo, Norway.'}]",BMC medical research methodology,['10.1186/s12874-019-0789-6'] 3476,30445488,Pair Matcher (PaM): fast model-based optimization of treatment/case-control matches.,"MOTIVATION In clinical trials, individuals are matched using demographic criteria, paired and then randomly assigned to treatment and control groups to determine a drug's efficacy. A chief cause for the irreproducibility of results across pilot to Phase-III trials is population stratification bias caused by the uneven distribution of ancestries in the treatment and control groups. RESULTS Pair Matcher (PaM) addresses stratification bias by optimizing pairing assignments a priori and/or a posteriori to the trial using both genetic and demographic criteria. Using simulated and real datasets, we show that PaM identifies ideal and near-ideal pairs that are more genetically homogeneous than those identified based on competing methods, including the commonly used principal component analysis (PCA). Homogenizing the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study. PaM's ancestral inferences also allow characterizing responders and developing a precision medicine approach to treatment. AVAILABILITY AND IMPLEMENTATION PaM is freely available via Rhttps://github.com/eelhaik/PAM and a web-interface at http://elhaik-matcher.sheffield.ac.uk/ElhaikLab/. SUPPLEMENTARY INFORMATION Supplementary data are available at Bioinformatics online.",2019,Homogenising the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study.,[],[],['Motivation'],[],[],"[{'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0321776,Homogenising the treatment (or case) and control groups can be expected to improve the accuracy and reproducibility of the trial or genetic study.,"[{'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Elhaik', 'Affiliation': 'Department of Animal and Plant Sciences, University of Sheffield, Sheffield UK, UK.'}, {'ForeName': 'Desmond M', 'Initials': 'DM', 'LastName': 'Ryan', 'Affiliation': 'Department of Animal and Plant Sciences, University of Sheffield, Sheffield UK, UK.'}]","Bioinformatics (Oxford, England)",['10.1093/bioinformatics/bty946'] 3477,31601357,Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.,"BACKGROUND Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. OBJECTIVES To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme. DESIGN A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken. SETTING Seven hospital rheumatology units in England and Wales. PARTICIPANTS Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids. INTERVENTIONS RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse. MAIN OUTCOME MEASURES Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis. RESULTS A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N  = 156/175; control, n/N  = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units; p  < 0.001) and the control interventions (-0.88 units; p  < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units; p  = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units; p  = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units, p  = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units, p  = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units, p  = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p  = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p  = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet ( p  < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others ( p  < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice. LIMITATIONS Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing. CONCLUSIONS The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms. FUTURE WORK Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost. TRIAL REGISTRATION Current Controlled Trials ISRCTN52709998. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.",2019,"The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms.","['Seven hospital rheumatology units in England and Wales', 'four consecutive cohorts within each of the seven centres', 'BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids', 'Adults with RA and fatigue severity of ≥\u20096 [out of 10, as measured by the', 'rheumatoid arthritis fatigue', 'A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N \u2009=\u2009156/175; control, n/N \u2009=\u2009152/158']","['RAFT programme', 'RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists', 'usual care alone (control', 'EQ-5D-5L', 'cognitive-behavioural therapy (CBT', 'group CBT programme']","['fatigue data', 'emotional fatigue', 'RA fatigue impact', 'Cost-effectiveness', 'Self-efficacy', 'total societal costs', 'Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale', 'mean BRAF-NRS impact', 'Satisfaction', 'NHS costs', 'Fatigue severity', 'clinical effectiveness and cost-effectiveness', 'Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",333.0,0.221487,"The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hewlett', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Almeida', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ambler', 'Affiliation': 'Pain Management Centre, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Section of Rheumatology, Division of Infection and Immunity, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dures', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford, Salford, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bryar', 'Initials': 'B', 'LastName': 'Kadir', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kirwan', 'Affiliation': 'Academic Rheumatology, Department of Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Plummer', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Rooke', 'Affiliation': 'Patient Research Partner, Academic Rheumatology, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Thorn', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23570'] 3478,31230020,"Protect-me: a parallel-group, triple blinded, placebo-controlled randomised clinical trial protocol assessing antenatal maternal melatonin supplementation for fetal neuroprotection in early-onset fetal growth restriction.","INTRODUCTION Fetal growth restriction (FGR) is a serious pregnancy complication, associated with increased rates of perinatal death and morbidity among survivors. Most commonly FGR results from placental insufficiency, where the placenta fails to deliver the oxygen and nutrients required for normal fetal growth. This leads to fetal oxidative stress, resulting in organ damage through lipid peroxidation. The early developing brain is particularly susceptible, such that FGR is associated with poorer neurodevelopment, witnessed as cognitive and behavioural dysfunction, and cerebral palsy. Promisingly, melatonin, a lipid soluble antioxidant is neuroprotective in animal models of FGR. We present a protocol outlining a randomised, placebo-controlled trial to explore whether antenatal maternal melatonin supplementation in pregnancies with severe, early-onset FGR can improve neurodevelopment among survivors at 2 years of age. METHODS AND ANALYSES We will recruit 336 women with a singleton pregnancy complicated by FGR between 23+0 and 31+6 weeks gestation. Participants will be randomised, stratified by gestational age, to either 30 mg melatonin per day or a visually identical placebo, continued until birth. Measures of maternal and fetal health will be collected until birth. Timing of birth will be determined by the treating clinical team in discussion with the woman. Neonatal and infant neurodevelopmental assessments will be undertaken, consisting of brain MRI at term corrected age, general movements assessment at term and 3 months' corrected age, and Bayley Scales of Infant & Toddler Development-III and Infant Toddler Social Emotional Assessment at 2.5 years corrected age. Analyses will be on intention to treat. The primary outcome is a difference of 5 points in the cognitive domain of the Bayley-III. Secondary outcomes address maternal and fetal safety. ETHICS AND DISSEMINATION This trial has Monash Health Human Research and Ethics committee approval (17-0000-583A). Findings will be disseminated through peer-reviewed publications, conference presentations and to participants. TRIAL REGISTRATION NUMBER ACTRN12617001515381; Pre-results.",2019,We will recruit 336 women with a singleton pregnancy complicated by FGR between 23+0 and 31+6 weeks gestation.,"['fetal neuroprotection in early-onset fetal growth restriction', '336 women with a singleton pregnancy complicated by FGR between 23+0\u2009and 31+6 weeks gestation', 'pregnancies with severe, early-onset FGR can improve neurodevelopment among survivors at 2 years of age']","['antenatal maternal melatonin supplementation', 'melatonin', 'placebo', 'melatonin per day or a visually identical placebo']","['maternal and fetal safety', 'Bayley Scales of Infant & Toddler Development-III and Infant Toddler Social Emotional Assessment', 'cognitive domain of the Bayley-III', 'maternal and fetal health']","[{'cui': 'C0598958', 'cui_str': 'Neuronal Protection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",336.0,0.425921,We will recruit 336 women with a singleton pregnancy complicated by FGR between 23+0 and 31+6 weeks gestation.,"[{'ForeName': 'Kirsten R', 'Initials': 'KR', 'LastName': 'Palmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Mockler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Davies-Tuck', 'Affiliation': 'The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Miller', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Stacy K', 'Initials': 'SK', 'LastName': 'Goergen', 'Affiliation': 'Department of Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Paediatric Neurology, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Anderson', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Groom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Euan M', 'Initials': 'EM', 'LastName': 'Wallace', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-028243'] 3479,31524133,Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT.,"BACKGROUND There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. OBJECTIVE To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. DESIGN Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. SETTING Acute and community stroke services in three sites in England. PARTICIPANTS Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales 'Sad' item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. RANDOMISATION AND BLINDING Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. INTERVENTIONS The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people's level of enjoyable or valued activities. The control arm received usual care only. MAIN OUTCOME MEASURES Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. RESULTS Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, n  = 18; usual care, n  = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. LIMITATIONS Target recruitment was not achieved, although we identified methods to improve recruitment. CONCLUSIONS The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. TRIAL REGISTRATION Current Controlled Trials ISRCTN12715175. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.",2019,"Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm.","['Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9', '25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care', 'Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month', 'post-stroke depression', 'Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention', 'sample size of between 580 and 623 participants', 'Acute and community stroke services in three sites in England']","['Behavioural activation therapy', 'Behavioural Activation Therapy', 'usual care only', 'usual stroke care', 'behavioural activation (BA']","['PHQ-9', ""Visual Analogue Mood Scales 'Sad' item"", 'Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire', 'Mean PHQ-9 scores']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0566000', 'cui_str': 'Unable to communicate (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0587667', 'cui_str': 'Stroke service (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy (regime/therapy)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",48.0,0.235793,"Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm.","[{'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'Thomas', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Avril Er', 'Initials': 'AE', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nadina B', 'Initials': 'NB', 'LastName': 'Lincoln', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Palmer', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Latimer', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Gemma L', 'Initials': 'GL', 'LastName': 'Hackney', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandefield', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rachael D', 'Initials': 'RD', 'LastName': 'Hatton', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Cooper', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Chater', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Callaghan', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coates', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Katie E', 'Initials': 'KE', 'LastName': 'Sutherland', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Sarah Jacob', 'Initials': 'SJ', 'LastName': 'Eshtan', 'Affiliation': 'Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Gogem', 'Initials': 'G', 'LastName': 'Topcu', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23470'] 3480,31957521,"Effects of Sodium Reduction on Energy, Metabolism, Weight, Thirst, and Urine Volume: Results From the DASH (Dietary Approaches to Stop Hypertension)-Sodium Trial.","Two recent studies challenged traditional paradigms of mammalian sodium physiology, suggesting that sodium reduction might cause weight gain by altering metabolism. This new theory has important implications for population-wide dietary recommendations. However, these observations have not been confirmed. In the DASH (Dietary Approaches to Stop Hypertension)-Sodium trial, 412 adults with systolic blood pressure of 120 to 159 mm Hg and diastolic blood pressure of 80 to 95 mm Hg not taking antihypertensive medications were randomly assigned to the DASH diet or a control diet (parallel design). On their assigned diet, participants randomly consumed each of the 3 sodium levels for 4 weeks (crossover design). Participants were provided all meals but could drink noncaloric beverages (eg, water) freely. Throughout the trial, energy intake was adjusted to maintain weight constant. The 3 sodium levels (at 2100 kcal/day) were: low (1150 mg of Na/day), medium (2300 mg of Na/day), and high (3450 mg of Na/day). Energy intake, weight, self-reported thirst, and 24-hour urine volume were assessed after each period. Participants were 57% women and 57% black; mean age was 48 years [SD, 10]). Among those assigned the control, mean weight increased slightly with higher sodium but not among those assigned DASH. Energy intake did not vary across sodium levels in either diet ( P -trends ≥0.36). Higher sodium resulted in more thirst ( P -trends <0.001 on both diets) and higher urine volume (suggesting higher fluid intake) during the control diet ( P -trend=0.007). Reducing sodium did not increase energy requirements to maintain stable weights but did decrease thirst and urine volume (control diet only), findings consistent with the traditional understanding of mammalian sodium physiology. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000608.",2020,Higher sodium resulted in more thirst ( P -trends <0.001 on both diets) and higher urine volume (suggesting higher fluid intake) during the control diet ( P -trend=0.007).,"['Participants were 57% women and 57% black; mean age was 48 years [SD, 10', '412 adults with systolic blood pressure of 120 to 159 mm\u2009Hg and diastolic blood pressure of 80 to 95 mm\u2009Hg not taking antihypertensive medications']","['Sodium Reduction', 'DASH diet or a control diet']","['higher urine volume', 'Energy, Metabolism, Weight, Thirst, and Urine Volume', 'mean weight', 'Energy intake', 'Energy intake, weight, self-reported thirst, and 24-hour urine volume']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0729389', 'cui_str': '24 hour urine volume - finding'}]",412.0,0.0294461,Higher sodium resulted in more thirst ( P -trends <0.001 on both diets) and higher urine volume (suggesting higher fluid intake) during the control diet ( P -trend=0.007).,"[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'From the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (S.P.J.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Kidney Health Research Institute, Geisinger Health System, Danville, PA (A.R.C.).'}, {'ForeName': 'Cheryl A M', 'Initials': 'CAM', 'LastName': 'Anderson', 'Affiliation': 'University of California San Diego, La Jolla (C.A.M.A.).'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Hall', 'Affiliation': 'University of Mississippi Medical Center, Jackson (J.E.H.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD (E.R.M., L.J.A.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13932'] 3481,31227535,Protocol for a double-blind placebo-controlled trial to evaluate the efficacy of probiotics in reducing antibiotics for infection in care home residents: the Probiotics to Reduce Infections iN CarE home reSidentS (PRINCESS) trial.,"INTRODUCTION Care home residents are at increased risk of infections and antibiotic prescription. Reduced antibiotic use from fewer infections would improve quality of life. The P robiotics to R educe I nfections i N C ar E home re S ident S (PRINCESS) trial aims to determine the efficacy and investigate mechanisms of daily probiotics on antibiotic use and incidence of infections in care home residents. METHODS AND ANALYSIS PRINCESS is a double-blind, individually randomised, placebo-controlled trial that will assess the effect of a daily oral probiotic combination of Lactobacillus rhamnosus, GG (LGG) and Bifidobacterium animalis subsp. lactis , BB-12 (BB-12) on cumulative antibiotic administration days (CAADs) (primary outcome) for infection in up to 330 care home residents aged ≥65 years over up to 12 months. Secondary outcomes include: Infection: Total number of days of antibiotic administration for each infection type (respiratory tract infection, urinary tract infection, gastrointestinal infection, unexplained fever and other); number, site, duration of infection; estimation of incidence and duration of diarrhoea and antibiotic-associated diarrhoea; Stool microbiology : Clostridium difficile infection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12. Oral microbiology: Candida spp. Health and well-being: Self and/or proxy health-related quality of life EQ5D (5 L); self-and/or proxy-reported ICEpop CAPability measure for older people. Hospitalisations: number and duration of all-cause hospital stays. Mortality: deaths. Mechanistic immunology outcomes: influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3. Findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to patient and policy stakeholders. TRIAL REGISTRATION NUMBER ISRCTN16392920; Pre-results.",2019,"influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3.","['care home residents', 'older people', '330 care home residents aged ≥65 years over up to 12\u2009months']","['probiotics', 'daily oral probiotic combination of Lactobacillus rhamnosus, GG (LGG) and Bifidobacterium animalis subsp', 'placebo', 'self-and/or proxy-reported ICEpop CAPability measure']","['influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response', 'lactis , BB-12 (BB-12) on cumulative antibiotic administration days (CAADs', 'Mortality: deaths', ' Infection: Total number of days of antibiotic administration for each infection type (respiratory tract infection, urinary tract infection, gastrointestinal infection, unexplained fever and other); number, site, duration of infection; estimation of incidence and duration of diarrhoea and antibiotic-associated diarrhoea; Stool microbiology : Clostridium difficile infection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12. Oral microbiology: Candida spp', 'quality of life']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C4082764', 'cui_str': 'Infection of gastrointestinal tract'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure (procedure)'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0034380'}]",,0.229602,"influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3.","[{'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Addison', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Downs', 'Affiliation': 'Lay Representative, Cardiff, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hobbs', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shepherd', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Alun', 'Initials': 'A', 'LastName': 'Toghill', 'Affiliation': 'Lay Representative, Cardiff, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology Cardiff, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027513'] 3482,31838259,Wood stove interventions and child respiratory infections in rural communities: KidsAir rationale and methods.,"BACKGROUND Acute lower respiratory tract infections (LRTIs) account for >27% of all hospitalizations among US children under five years of age. Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards. This is concerning as PM 2.5 exposure is associated with many adverse health outcomes, including a greater than three-fold increased risk of LRTIs. Evidence-based efforts are warranted in rural and American Indian/Alaska Native (AI/AN) communities in the US that suffer from elevated rates of childhood LRTI and commonly use wood for residential heating. DESIGN In three rural and underserved settings, we conducted a three-arm randomized controlled, post-only intervention trial in wood stove homes with children less than five years old. Education and household training on best-burn practices were introduced as one intervention arm (Tx1). This intervention was evaluated against an indoor air filtration unit arm (Tx2), as well as a control arm (Tx3). The primary outcome was LRTI incidence among children under five years of age. DISCUSSION To date, exposure reduction strategies in wood stove homes have been either inconsistently effective or include factors that limit widespread dissemination and continued compliance in rural and economically disadvantaged populations. As part of the ""KidsAIR"" study described herein, the overall hypothesis was that a low-cost, educational intervention targeting indoor wood smoke PM 2.5 exposures would be a sustainable approach for reducing children's risk of LRTI in rural and AI/AN communities.",2020,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"['wood stove homes with children less than five years old', 'rural communities', 'In three rural and underserved settings']","['Education and household training', 'Wood stove interventions']",['LRTI incidence among children under five years of age'],"[{'cui': 'C1268550', 'cui_str': 'Wood stove'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1268550', 'cui_str': 'Wood stove'}]","[{'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.0646851,Residential burning of biomass for heat leads to elevated indoor levels of fine particulate matter (PM 2.5 ) that often exceed current health based air quality standards.,"[{'ForeName': 'Curtis W', 'Initials': 'CW', 'LastName': 'Noonan', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA. Electronic address: curtis.noonan@umontana.edu.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Semmens', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Desirae', 'Initials': 'D', 'LastName': 'Ware', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Boyer', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Erdei', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Scarlett E', 'Initials': 'SE', 'LastName': 'Hopkins', 'Affiliation': 'Center for Alaska Native Health Research, University of Alaska Fairbanks, AK, USA; Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'Johnnye', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'Community Environmental Health Program, University of New Mexico College of Pharmacy, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Tony J', 'Initials': 'TJ', 'LastName': 'Ward', 'Affiliation': 'Center for Population Health Research, School of Public and Community Health Sciences, University of Montana, Missoula, MT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105909'] 3483,31707266,Predictors of adherence to nicotine replacement therapy: Machine learning evidence that perceived need predicts medication use.,"BACKGROUND Nonadherence to smoking cessation medication is a frequent problem. Identifying pre-quit predictors of nonadherence may help explain nonadherence and suggest tailored interventions to address it. AIMS Identify and characterize subgroups of smokers based on adherence to nicotine replacement therapy (NRT). METHOD Secondary classification tree analyses of data from a 2-arm randomized controlled trial of Recommended Usual Care (R-UC, n = 315) versus Abstinence-Optimized Treatment (A-OT, n = 308) were conducted. R-UC comprised 8 weeks of nicotine patch plus brief counseling whereas A-OT comprised 3 weeks of pre-quit mini-lozenges, 26 weeks of nicotine patch plus mini-lozenges, 11 counseling contacts, and 7-11 automated reminders to use medication. Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use. Greater quitting motivation and confidence, and believing that stop smoking medication was safe and easy to use were associated with greater adherence. CONCLUSION Adherence was especially high in those who were more dependent and more exposed to smoking triggers. Quitting motivation and confidence predicted greater adherence, while negative beliefs about medication safety and acceptability predicted worse adherence. Results suggest that adherent use of medication may reflect a rational appraisal of the likelihood that one will need medication and will benefit from it.",2019,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.",[],"['Usual Care (R-UC, n\u202f=\u202f315) versus Abstinence-Optimized Treatment', 'nicotine replacement therapy (NRT', 'nicotine patch plus brief counseling', 'nicotine patch plus mini-lozenges']",['Adherence'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]",[],315.0,0.0202661,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. RESULTS Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA. Electronic address: nkim86@ctri.wisc.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Wei-Yin', 'Initials': 'WY', 'LastName': 'Loh', 'Affiliation': 'Department of Statistics, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107668'] 3484,31619359,Cross-Linking-Assisted Infection Reduction: A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Outcomes in Fungal Keratitis.,"PURPOSE To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare natamycin versus amphotericin B for filamentous fungal keratitis. DESIGN Outcome-masked, 2×2 factorial design, randomized controlled clinical trial. PARTICIPANTS Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. METHODS Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical natamycin 5% alone, (2) topical natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL. MAIN OUTCOME MEASURES The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. RESULTS Those randomized to CXL regardless of medication (topical natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57-3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47-2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, -0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03-0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. CONCLUSIONS There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.",2020,"There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. ","['Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India', 'Study eyes', 'Fungal Keratitis']","['Adjuvant Cross-Linking', 'Cross-Linking-Assisted Infection Reduction', 'CXL', 'natamycin versus amphotericin B', 'amphotericin', 'topical natamycin 5% alone, (2) topical natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL', 'medication (topical natamycin or amphotericin', 'adjuvant corneal crosslinking (CXL']","['24-hour culture positivity', 'microbiological cure at 24 hours on repeat culture', 'odds of 24-hour culture positivity', 'spectacle-corrected visual acuity (BSCVA', 'baseline visual acuity', 'visual acuity', 'infiltrate or scar size, percentage of epithelialized or adverse events', 'epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0085795', 'cui_str': 'Amphotericin'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.445403,"There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. ","[{'ForeName': 'N Venkatesh', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Prajna', 'Initials': 'P', 'LastName': 'Lalitha', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California; The Permanente Medical Group, Redwood City, California. Electronic address: jennifer.rose.nussbaumer@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.029'] 3485,31175814,Active and Passive Rhythmic Music Therapy Interventions Differentially Modulate Sympathetic Autonomic Nervous System Activity.,"Dysregulation of the autonomic nervous system (ANS) and the hypothalamic-pituitary-adrenal (HPA) axis has been implicated in psychiatric disorders. Music therapy (MT) has been shown to modulate heart-rate variability (HRV) and salivary stress markers, physiological markers of the ANS and HPA axes, respectively. Given the prominent role of arousal and stress physiology in many psychiatric disorders, MT has the potential to provide therapeutic benefits in psychiatry. Active MT requires patients to engage rhythmically with music; in contrast, passive MT requires patients to listen to music, eliminating the rhythmic movement seen in active MT. Yet, it remains unknown whether active or passive MT differentially modulates arousal and stress physiology. We contrasted the effects of active and passive MT experiences to examine the differential impact of rhythmic movement on the ANS and HPA axes in healthy participants. Individuals (N = 16) participated in a crossover study of 40 min of an active MT and a passive MT intervention. HRV recordings and saliva samples were collected both before and after each intervention. The high-frequency component (HF) and the ratio of low-frequency to high-frequency components (LF/HF) were calculated as cardiac markers of parasympathetic and sympathetic ANS activation, respectively. Saliva samples were analyzed for alpha-amylase and cortisol, markers of the sympathetic ANS and HPA axes, respectively. Active MT and passive MT interventions differentially modulated LF/HF, where active MT decreased LF/HF and passive MT increased LF/HF. These results indicate that MT affects the ANS and suggests that differences in engagement between active MT and passive MT lead to a differential modulation of the sympathetic ANS.",2019,"Active MT and passive MT interventions differentially modulated LF/HF, where active MT decreased LF/HF and passive MT increased LF/HF.","['Individuals (N = 16) participated in a crossover study of 40 min of an', 'healthy participants']","['active MT and a passive MT intervention', 'Active and Passive Rhythmic Music Therapy Interventions', 'Music therapy (MT']",['HRV recordings and saliva samples'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",16.0,0.0337467,"Active MT and passive MT interventions differentially modulated LF/HF, where active MT decreased LF/HF and passive MT increased LF/HF.","[{'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'McPherson', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Dorita', 'Initials': 'D', 'LastName': 'Berger', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sankaraleengam', 'Initials': 'S', 'LastName': 'Alagapan', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Journal of music therapy,['10.1093/jmt/thz007'] 3486,30550306,Feel free to write this down: Writing about a stressful experience does not impair change detection task performance.,"Acute stress impairs working memory (i.e., the ability to update and keep information in mind). Although that effect is well established, the boundaries around it are not. In particular, little is known about how recalling an unresolved stressor might influence working memory, or about how stress-or recalling a stressful event-influences the processes underlying working memory task performance (e.g., sustained/controlled attention vs. capacity). We addressed these issues in the present study (N = 171) by randomly assigning participants to write about an unresolved, extremely stressful experience (stressful writing condition; n = 85) or the events of the prior day (control condition; n = 86), and, subsequently, both measured change detection task performance and used computational cognitive modeling to estimate the processes underlying it-namely, attention, capacity, and bias. We found that, relative to the control task, writing about a stressful experience neither impaired performance on the change detection task nor altered any of the processes underlying performance on that task. These results show that the effects of writing about an unresolved, stressful episode do not parallel effects of acute stress on working memory, indicating that experiencing a stressor may have very different cognitive effects than recalling it at a later time. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"We found that, relative to the control task, writing about a stressful experience neither impaired performance on the change detection task nor altered any of the processes underlying performance on that task.",[],[],[],[],[],[],,0.029415,"We found that, relative to the control task, writing about a stressful experience neither impaired performance on the change detection task nor altered any of the processes underlying performance on that task.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychology, University of California, Davis.'}, {'ForeName': 'Chandler M', 'Initials': 'CM', 'LastName': 'Spahr', 'Affiliation': 'Department of Psychology, University of California, Davis.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Yonelinas', 'Affiliation': 'Department of Psychology, University of California, Davis.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000549'] 3487,31157878,Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial.,"Importance Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. Objective To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months. Design, Setting, and Participants This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016. Interventions Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention. Main Outcomes and Measures The study's primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey. Results Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, -12%; 95% CI, -26% to 3%; P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, -18%; 95% CI, -34% to -3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group. Conclusions and Relevance In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation. Trial Registration ClinicalTrials.gov identifier: NCT02313181.",2019,"Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049).","['Participants were enrolled from January 2015 through September 2016', '2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age', 'Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other', 'Results\n\n\nEighty-two newborns']","['ELF', 'Early Limited Formula', 'control dyads, who continued exclusive breastfeeding and received a safety teaching intervention', 'Interventions\n\n\nEarly Limited Formula (ELF']","['Breastfeeding Duration', 'Marital status and intended breastfeeding duration', 'age at breastfeeding cessation and any breastfeeding at 12 months', 'Median (interquartile range) duration of breastfeeding', 'breastfeeding duration', 'shorter mean (SD) intended duration of breastfeeding']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",164.0,0.169822,"Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049).","[{'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Flaherman', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.1424'] 3488,31588904,The Effect of Robot Attentional Behaviors on User Perceptions and Behaviors in a Simulated Health Care Interaction: Randomized Controlled Trial.,"BACKGROUND For robots to be effectively used in health applications, they need to display appropriate social behaviors. A fundamental requirement in all social interactions is the ability to engage, maintain, and demonstrate attention. Attentional behaviors include leaning forward, self-disclosure, and changes in voice pitch. OBJECTIVE This study aimed to examine the effect of robot attentional behaviors on user perceptions and behaviors in a simulated health care interaction. METHODS A parallel randomized controlled trial with a 1:1:1:1 allocation ratio was conducted. We randomized participants to 1 of 4 experimental conditions before engaging in a scripted face-to-face interaction with a fully automated medical receptionist robot. Experimental conditions included a self-disclosure condition, voice pitch change condition, forward lean condition, and neutral condition. Participants completed paper-based postinteraction measures relating to engagement, perceived robot attention, and perceived robot empathy. We video recorded interactions and coded for participant attentional behaviors. RESULTS A total of 181 participants were recruited from the University of Auckland. Participants who interacted with the robot in the forward lean and self-disclosure conditions found the robot to be significantly more stimulating than those who interacted with the robot in the voice pitch or neutral conditions (P=.03). Participants in the forward lean, self-disclosure, and neutral conditions found the robot to be significantly more interesting than those in the voice pitch condition (P<.001). Participants in the forward lean and self-disclosure conditions spent significantly more time looking at the robot than participants in the neutral condition (P<.001). Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001). CONCLUSIONS The use of self-disclosure and forward lean by a health care robot can increase human engagement and attentional behaviors. Voice pitch changes did not increase attention or engagement. The small effects with regard to participant perceptions are potentially because of the limitations in self-report measures or a lack of comparison for most participants who had never interacted with a robot before. Further research could explore the use of self-disclosure and forward lean using a within-subjects design and in real health care settings.",2019,"Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001). ","['User Perceptions and Behaviors in a Simulated Health Care Interaction', 'A total of 181 participants were recruited from the University of Auckland', 'participants who had never interacted with a robot before']","['4 experimental conditions before engaging in a scripted face-to-face interaction with a fully automated medical receptionist robot', 'robot attentional behaviors', 'Robot Attentional Behaviors']","['self-disclosure condition, voice pitch change condition, forward lean condition, and neutral condition', 'Attentional behaviors include leaning forward, self-disclosure, and changes in voice pitch', 'time looking', 'Voice pitch changes']","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0025099', 'cui_str': 'Medical Receptionists'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0036596', 'cui_str': 'Self Disclosure'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0518179', 'cui_str': 'Change in voice (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",181.0,0.0497982,"Significantly, more participants in the self-disclosure condition laughed during the interaction (P=.01), whereas significantly more participants in the forward lean condition leant toward the robot during the interaction (P<.001). ","[{'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Johanson', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'MacDonald', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Byeong Kyu', 'Initials': 'BK', 'LastName': 'Ahn', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'JongYoon', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Euijun', 'Initials': 'E', 'LastName': 'Hwang', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Sutherland', 'Affiliation': 'Centre for Automation and Robotic Engineering Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",Journal of medical Internet research,['10.2196/13667'] 3489,31517749,Interindividual Balance Adaptations in Response to Perturbation Treadmill Training in Persons With Parkinson Disease.,"BACKGROUND AND PURPOSE Perturbation training is a promising approach to reduce fall incidence in persons with Parkinson disease (PwPD). This study aimed to evaluate interindividual differences in balance adaptations in response to perturbation treadmill training (PTT) and identify potential outcome predictors. METHODS PwPD (n = 43, Hoehn & Yahr stage 1-3.5) were randomly assigned to either 8 weeks of PTT or conventional treadmill training (CTT) without perturbations. At baseline and following intervention, data from 4 domains of balance function (reactive, anticipatory, dynamic postural control, and quiet stance) were collected. Using responder analysis we investigated interindividual differences (responder rates and magnitude of change) and potential predictive factors. RESULTS PTT showed a significantly higher responder rate in the Mini Balance Evaluation Systems Test (Mini-BESTest) subscore reactive postural control, compared with CTT (PTT = 44%; CTT = 10%; risk ratio = 4.22, confidence interval = 1.03-17.28). Additionally, while between-groups differences were not significant, the proportion of responders in the measures of dynamic postural control was higher for PTT compared with CTT (PTT: 22%-39%; CTT: 5%-10%). The magnitude of change in responders and nonresponders was similar in both groups. PTT responders showed significantly lower initial balance performance (4/8 measures) and cognitive function (3/8 measures), and were older and at a more advanced disease stage, based on descriptive evaluation. DISCUSSION AND CONCLUSIONS Our findings suggest that PTT is beneficial to improve reactive balance in PwPD. Further, PTT appeared to be effective only for a part of PwPD, especially for those with lower balance and cognitive function, which needs further attention.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A1).",2019,"PTT responders showed significantly lower initial balance performance (4/8 measures) and cognitive function (3/8 measures), and were older and at a more advanced disease stage, based on descriptive evaluation. ","['PwPD (n = 43, Hoehn & Yahr stage 1-3.5', 'persons with Parkinson disease (PwPD', 'Persons With Parkinson Disease']","['Perturbation Treadmill Training', 'PTT or conventional treadmill training (CTT) without perturbations', 'PTT', 'perturbation treadmill training (PTT']","['dynamic postural control', 'balance function (reactive, anticipatory, dynamic postural control, and quiet stance', 'Mini Balance Evaluation Systems Test (Mini-BESTest) subscore reactive postural control', 'cognitive function', 'responder rate', 'reactive balance', 'initial balance performance']","[{'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0342955,"PTT responders showed significantly lower initial balance performance (4/8 measures) and cognitive function (3/8 measures), and were older and at a more advanced disease stage, based on descriptive evaluation. ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Klamroth', 'Affiliation': 'Department of Sport Science and Sport, Friedrich-Alexander-University (FAU) Erlangen-Nürnberg, Erlangen, Germany (S.K., K.P., S.S.); Molecular Neurology, University Hospital Erlangen, FAU Erlangen-Nürnberg, Erlangen, Germany (H.G., J.W., J.K.); and Machine Learning and Data Analytics Lab, FAU Erlangen-Nürnberg, Erlangen, Germany (B.E.).'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Gaßner', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Winkler', 'Affiliation': ''}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Eskofier', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klucken', 'Affiliation': ''}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeifer', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Steib', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000291'] 3490,31874891,"Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol.","INTRODUCTION A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa. METHODS AND ANALYSIS A three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip. ETHICS AND DISSEMINATION This study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990-1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications. TRIAL REGISTRATION NUMBER NCT03751826; Pre-results.",2019,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa. ","['Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months', 'young women in rural KwaZulu-Natal, South Africa', 'young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa']","['HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks', 'peer delivery HIV self-testing to support linkage to HIV prevention', 'peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution', ""incentivised-peer-networks: peer-navigators recruited participants 'seeds' to distribute up to five HIVST packs and HIV prevention information to peers within their social networks"", 'antiretroviral therapy and pre-exposure prophylaxis (PrEP']","['linkage rate', 'peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",24.0,0.104928,"A cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa. ","[{'ForeName': 'Oluwafemi Atanda', 'Initials': 'OA', 'LastName': 'Adeagbo', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nondumiso', 'Initials': 'N', 'LastName': 'Mthiyane', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Herbst', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mee', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neuman', 'Affiliation': 'Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jaco', 'Initials': 'J', 'LastName': 'Dreyer', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Natsayi', 'Initials': 'N', 'LastName': 'Chimbindi', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Smit', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Okesola', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Department of HIV/AIDS, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Harare, Zimbabwe.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Cowan', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Corbett', 'Affiliation': 'Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa m.shahmanesh@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033435'] 3491,31135821,Association Between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada.,"Importance Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results The final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.",2019,"No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. ","['The final cohort comprised 28\u202f468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years', 'patients included in the study (n\u2009=\u200928\u202f468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation', 'Participants\n\n\nThis interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system', 'Patients from the province of Quebec', 'randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2']",[],"['survival or clinical outcomes', 'proportion of early dialysis starts', 'monthly proportion of early dialysis starts', 'acute inpatient dialysis initiations']","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0260039', 'cui_str': 'Nephrologists'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C3850092', 'cui_str': 'Interrupted Time Series'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C3811844'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",[],"[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",28468.0,0.167033,"No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. ","[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Ferguson', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Manish M', 'Initials': 'MM', 'LastName': 'Sood', 'Affiliation': 'The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rigatto', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chau', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Komenda', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Naimark', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Gihad E', 'Initials': 'GE', 'LastName': 'Nesrallah', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Soroka', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Beaulieu', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Department of Medicine, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'S Joseph', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Manns', 'Affiliation': ""O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0489'] 3492,30165595,Progressive Resistance Training Improves Torque Capacity and Strength in Mobility-Limited Older Adults.,"BACKGROUND Progressive resistance training (PRT) is consistently shown to improve muscle strength in older adults. The efficacy of PRT to improve muscle fatigue in older adults with demonstrated mobility limitations remains unclear. METHODS Mobility-limited (Short Physical Performance Battery [SPPB] ≤ 9) older adults (age 70-92 years) were recruited for this study and randomized to either PRT or home-based flexibility (FLEX) 3 d/wk for 12 weeks. Muscle fatigue and strength outcomes were assessed at baseline and 12 weeks. The primary outcome was torque capacity, a composite measure of strength and fatigue, defined as the sum of peak torques from an isokinetic fatigue test. RESULTS Seventy participants were randomized (mean [SD] age 78.9 [5.4] years; 60% female; mean [SD] SPPB 7.5 [1.6]). At follow-up, the PRT group improved significantly in torque capacity, mean between-group difference (95% confidence interval) 466.19 (138.4, 793.97) Nm (p = .006), and maximal strength 127.3 (60.96, 193.61) Nm (p = .0003), when compared with FLEX group. Neither group demonstrated significant changes in muscle fatigue or torque variability. CONCLUSION Twelve weeks of PRT improved torque capacity, as well as strength in mobility-limited older adults. These results demonstrate PRT improves multiple age-related muscular impairments.",2019,"Neither group demonstrated significant changes in muscle fatigue or torque variability. ","['70 subjects were randomized [mean (SD) age 78.9 (5.4) years; 60% female; mean (SD) SPPB 7.5 (1.6', 'Methods\n\n\nMobility-limited (Short Physical Performance Battery (SPPB) ≤9) older adults (age 70 - 92 yrs', 'mobility-limited older adults', 'older adults']","['Progressive resistance training', 'PRT or home-based flexibility (FLEX', 'PRT', '\n\n\nProgressive resistance training (PRT']","['torque capacity, a composite measure of strength and fatigue, defined as the sum of peak torques from an isokinetic fatigue test', 'torque capacity', 'muscle fatigue', 'muscle fatigue or torque variability', 'Muscle fatigue and strength outcomes', 'torque capacity and strength']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}]",70.0,0.0544578,"Neither group demonstrated significant changes in muscle fatigue or torque variability. ","[{'ForeName': 'Davis A', 'Initials': 'DA', 'LastName': 'Englund', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lori Lyn', 'Initials': 'LL', 'LastName': 'Price', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Grosicki', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Astellas Pharma, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': 'Astellas Pharma, Tokyo, Japan.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly199'] 3493,30994090,"Safety and Differential Antibody and T-Cell Responses to the Plasmodium falciparum Sporozoite Malaria Vaccine, PfSPZ Vaccine, by Age in Tanzanian Adults, Adolescents, Children, and Infants.","In 2016, there were more cases and deaths caused by malaria globally than in 2015. An effective vaccine would be an ideal additional tool for reducing malaria's impact. Sanaria ® PfSPZ Vaccine, composed of radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum (Pf) sporozoites (SPZ) has been well tolerated and safe in malaria-naïve and experienced adults in the United States and Mali and protective against controlled human malaria infection with Pf in the United States and field transmission of Pf in Mali, but had not been assessed in younger age groups. We, therefore, evaluated PfSPZ Vaccine in 93 Tanzanians aged 45 years to 6 months in a randomized, double-blind, normal saline placebo-controlled trial. There were no significant differences in adverse events between vaccinees and controls or between dosage regimens. Because all age groups received three doses of 9.0 × 10 5 PfSPZ of PfSPZ Vaccine, immune responses were compared at this dosage. Median antibody responses against Pf circumsporozoite protein and PfSPZ were highest in infants and lowest in adults. T-cell responses were highest in 6-10-year olds after one dose and 1-5-year olds after three doses; infants had no significant positive T-cell responses. The safety data were used to support initiation of trials in > 300 infants in Kenya and Equatorial Guinea. Because PfSPZ Vaccine-induced protection is thought to be mediated by T cells, the T-cell data suggest PfSPZ Vaccine may be more protective in children than in adults, whereas infants may not be immunologically mature enough to respond to the PfSPZ Vaccine immunization regimen assessed.",2019,Median antibody responses against Pf circumsporozoite protein and PfSPZ were highest in infants and lowest in adults.,"['93 Tanzanians aged 45 years to 6 months', '300 infants in Kenya and Equatorial Guinea', 'Tanzanian Adults, Adolescents, Children, and Infants', 'infants and lowest in adults']","['cryopreserved Plasmodium falciparum (Pf) sporozoites (SPZ', 'PfSPZ Vaccine', 'normal saline placebo']","['Safety and Differential Antibody and T-Cell Responses', 'Median antibody responses against Pf circumsporozoite protein and PfSPZ', 'adverse events', 'T-cell responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0014651', 'cui_str': 'Spanish Guinea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0562648', 'cui_str': 'Sporozoites'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.133569,Median antibody responses against Pf circumsporozoite protein and PfSPZ were highest in infants and lowest in adults.,"[{'ForeName': 'Said A', 'Initials': 'SA', 'LastName': 'Jongo', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'L W Preston', 'Initials': 'LWP', 'LastName': 'Church', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Ali T', 'Initials': 'AT', 'LastName': 'Mtoro', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Sumana', 'Initials': 'S', 'LastName': 'Chakravarty', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Ruben', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kamaka R', 'Initials': 'KR', 'LastName': 'Kassim', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Mpina', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Anneth-Mwasi', 'Initials': 'AM', 'LastName': 'Tumbo', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Florence A', 'Initials': 'FA', 'LastName': 'Milando', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Munira', 'Initials': 'M', 'LastName': 'Qassim', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Juma', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Bakari M', 'Initials': 'BM', 'LastName': 'Bakari', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Beatus', 'Initials': 'B', 'LastName': 'Simon', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kc', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Saverino', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gondwe', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Studer', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Fink', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Cosi', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'El-Khorazaty', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Styers', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Seder', 'Affiliation': 'Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daubenberger', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Protein Potential LLC, Rockville, Maryland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Tanner', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdulla', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-0835'] 3494,30202946,The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.,"BACKGROUND The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results. METHODS Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment. RESULTS Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782. CONCLUSION Recruitment for ω-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.",2019,The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.,"['1,087 participants had slow gait speed (<1 m/s', '289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the', 'Methods\n\n\nEligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment', 'older adults with mobility impairment', 'Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized', 'Seniors (ENRGISE', 'A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening']","['omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan', 'losartan']",['walking speed'],"[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",289.0,0.173642,The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors.,"[{'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lovato', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Talton', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Anton', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Stowe', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walkup', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Radiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly204'] 3495,31953303,"Randomized, Controlled Trial of Tacrolimus and Prednisolone Monotherapy for Adults with De Novo Minimal Change Disease: A Multicenter, Randomized, Controlled Trial.","BACKGROUND AND OBJECTIVES Minimal change disease is an important cause of nephrotic syndrome in adults. Corticosteroids are first-line therapy for minimal change disease, but a prolonged course of treatment is often required and relapse rates are high. Patients with minimal change disease are therefore often exposed to high cumulative corticosteroid doses and are at risk of associated adverse effects. This study investigated whether tacrolimus monotherapy without corticosteroids would be effective for the treatment of de novo minimal change disease. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS This was a multicenter, prospective, open-label, randomized, controlled trial involving six nephrology units across the United Kingdom. Adult patients with first presentation of minimal change disease and nephrotic syndrome were randomized to treatment with either oral tacrolimus at 0.05 mg/kg twice daily, or prednisolone at 1 mg/kg daily up to 60 mg daily. The primary outcome was complete remission of nephrotic syndrome after 8 weeks of therapy. Secondary outcomes included remission of nephrotic syndrome at 16 and 26 weeks, rates of relapse of nephrotic syndrome, and changes from baseline kidney function. RESULTS There were no significant differences between the tacrolimus and prednisolone treatment cohorts in the proportion of patients in complete remission at 8 weeks (21 out of 25 [84%] for prednisolone and 17 out of 25 [68%] for tacrolimus cohorts; P =0.32; difference in remission rates was 16%; 95% confidence interval [95% CI], -11% to 40%), 16 weeks (23 out of 25 [92%] for prednisolone and 19 out of 25 [76%] for tacrolimus cohorts; P =0.25; difference in remission rates was 16%; 95% CI, -8% to 38%), or 26 weeks (23 out of 25 [92%] for prednisolone and 22 out of 25 [88%] for tacrolimus cohorts; P =0.99; difference in remission rates was 4%; 95% CI, -17% to 25%). There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission (P =0.99) or in the time from complete remission to relapse. CONCLUSIONS Tacrolimus monotherapy can be effective alternative treatment for patients wishing to avoid steroid therapy for minimal change disease. PODCAST This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_01_16_CJN06180519.mp3.",2020,"There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission (P =0.99), or in the time from complete remission to relapse. ","['Adults with De Novo', 'patients wishing to avoid steroid therapy for minimal change disease', 'six nephrology units across the United Kingdom', 'Adult patients with first presentation of minimal change disease and nephrotic syndrome', 'nephrotic syndrome in adults', 'Patients with minimal change disease']","['prednisolone', 'tacrolimus monotherapy without corticosteroids', 'Corticosteroids', 'oral tacrolimus', 'Tacrolimus and Prednisolone Monotherapy', 'PODCAST']","['complete remission of nephrotic syndrome', 'relapse rates', 'Minimal Change Disease', 'remission rates', 'rates of relapse of nephrotic syndrome, and changes from baseline kidney function', 'remission of nephrotic syndrome', 'complete remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0439629', 'cui_str': 'First presentation (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.353176,"There was no significant difference in relapse rates (17 out of 23 [74%] for prednisolone and 16 out of 22 [73%] for tacrolimus cohorts) for patients in each group who achieved complete remission (P =0.99), or in the time from complete remission to relapse. ","[{'ForeName': 'Nicholas Rhys', 'Initials': 'NR', 'LastName': 'Medjeral-Thomas', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'The Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Condon', 'Affiliation': 'South West Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, Epsom, United Kingdom.'}, {'ForeName': 'Bhrigu', 'Initials': 'B', 'LastName': 'Sood', 'Affiliation': 'South West Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, Epsom, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Warwicker', 'Affiliation': 'The Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Pattison', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Barratt', 'Affiliation': 'Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom; and.'}, {'ForeName': 'H Terence', 'Initials': 'HT', 'LastName': 'Cook', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Levy', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Lightstone', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Galliford', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cairns', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom; m.e.griffith@ic.ac.uk.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06180519'] 3496,31774015,Effects of long-term aerobic training and detraining on functional capacity and quality of life in hemodialysis patients: A pilot study.,"Although previous studies have shown the benefits of exercise training in hemodialysis patients, little is known about the effects of long-term of exercise program on these patients. We investigated the effects and the safety of long-term aerobic training and the effects of detraining on functional capacity and quality of life in hemodialysis patients. Ten patients were allocated to two groups: training and detraining. The training group completed at least 30 months of aerobic training, and the detraining group completed at least 20 months and then discontinued the training for at least 10 months. The outcomes were analyzed at baseline, after 3 months of aerobic training and at the 30-month follow-up. The training and detraining groups performed 37 (5.5) and 24 (3.0) months of aerobic training, respectively. The detraining group discontinued the training for 11.0 (2.0) months. After 3 months of aerobic training, six-minute walking test distance increased significantly in both groups (training group = 569 (287.8) vs 635.5 (277.0) m, p  = 0.04; detraining group = 454.5 (72.3) vs 515.0 (91.8) m, p  = 0.04). There was no significant difference in the six-minute walking test distance in the training group (576.5 (182.5), p   >   0.05 ) and a significant decrease (436.2 (89.6) m, p  = 0.04) in the detraining group at the follow-up compared to the third month of aerobic training. No significant difference was observed in quality of life during the study. No complications were found during the protocol of the exercise. These results suggest that long-term aerobic training is safe and can maintain functional capacity in hemodialysis patients. In contrast, detraining can result in loss of functional capacity in these patients.",2020,"After 3 months of aerobic training, six-minute walking test distance increased significantly in both groups (training group = 569 (287.8) vs 635.5 (277.0) m, p  = 0.04; detraining group = 454.5 (72.3) vs 515.0 (91.8) m, p  = 0.04).",['hemodialysis patients'],"['aerobic training', 'long-term aerobic training', 'exercise training', 'training and detraining', 'long-term aerobic training and detraining']","['six-minute walking test distance', 'functional capacity and quality of life', 'quality of life']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429925', 'cui_str': 'Test distance (observable entity)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}]",569.0,0.0175065,"After 3 months of aerobic training, six-minute walking test distance increased significantly in both groups (training group = 569 (287.8) vs 635.5 (277.0) m, p  = 0.04; detraining group = 454.5 (72.3) vs 515.0 (91.8) m, p  = 0.04).","[{'ForeName': 'Emanuele Poliana Lawall', 'Initials': 'EPL', 'LastName': 'Gravina', 'Affiliation': 'School of Physiotherapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Bruno Valle', 'Initials': 'BV', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Medicine, School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Luciana Angélica', 'Initials': 'LA', 'LastName': 'da Silva Jesus', 'Affiliation': 'School of Physiotherapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Lilian Pinto', 'Initials': 'LP', 'LastName': 'da Silva', 'Affiliation': 'School of Physiotherapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Rodolfo Nazareth', 'Initials': 'RN', 'LastName': 'da Silva', 'Affiliation': 'School of Physiotherapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Silva', 'Affiliation': 'School of Physiotherapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Rogério Baumgratz', 'Initials': 'RB', 'LastName': 'de Paula', 'Affiliation': 'Núcleo Interdisciplinar de Estudos, Pesquisas e Tratamento em Nefrologia (NIEPEN), Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Maycon Moura', 'Initials': 'MM', 'LastName': 'Reboredo', 'Affiliation': 'Department of Medicine, School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}]",The International journal of artificial organs,['10.1177/0391398819890622'] 3497,24366613,Differences in effects of omalizumab on late-phase responses to allergen challenge in the skin and nose at the time of basophil hyporesponsiveness.,,2014,,[],['omalizumab'],[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}]",[],,0.0236542,,"[{'ForeName': 'Miya O', 'Initials': 'MO', 'LastName': 'Paterniti', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Breslin', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Courneya', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Sterba', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hamilton', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'MacGlashan', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarbjit S', 'Initials': 'SS', 'LastName': 'Saini', 'Affiliation': 'Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA. Electronic address: ssaini@jhmi.edu.'}]",The Journal of investigative dermatology,['10.1038/jid.2013.541'] 3498,32044190,Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain.,"OBJECTIVE Although peer coaching can help patients manage chronic conditions, few studies have evaluated the effects of peer coaching on coaches, and no studies have systematically examined these effects in the context of chronic pain coaching. METHODS Peer coach outcomes were assessed as part of a randomized trial of peer coaching for chronic pain. In this exploratory analysis, linear mixed models were used to evaluate changes in peer coaches' pain and related outcomes from baseline to 6 and 9 months. The Šidák method was used to account for multiple comparisons. RESULTS Peer coaches (N = 55) experienced statistically significant increases in anxiety and pain catastrophizing from baseline to 6 months, which were no longer significant after adjustment. All other changes were not statistically significant. CONCLUSIONS Despite prior studies suggesting that peer coaches benefit from serving as a coach, the current study failed to support that conclusion. PRACTICE IMPLICATIONS Peer coaching remains a promising model, with high potential for implementation, for a number of chronic conditions requiring self-management. However, to maximize the benefits of such interventions, it is essential to monitor both those being coached and the coaches themselves, and not to assume that serving as a coach is inherently beneficial.",2020,"RESULTS Peer coaches (N = 55) experienced statistically significant increases in anxiety and pain catastrophizing from baseline to 6 months, which were no longer significant after adjustment.",['patients with chronic pain'],['peer coaching'],['anxiety and pain catastrophizing'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0457985,"RESULTS Peer coaches (N = 55) experienced statistically significant increases in anxiety and pain catastrophizing from baseline to 6 months, which were no longer significant after adjustment.","[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Matthias', 'Affiliation': 'US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA; Regenstrief Institute, Indianapolis, IN, USA; Department of Communication Studies, Indiana University-Purdue University, Indianapolis, IN, USA; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: mmatthia@iupui.edu.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Daggy', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ofner', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'McGuire', 'Affiliation': 'US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA; Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Kukla', 'Affiliation': 'US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA; Department of Psychology, Indiana University-Purdue University, Indianapolis, IN, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA; Regenstrief Institute, Indianapolis, IN, USA; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.007'] 3499,31884902,Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes.,"Background and Purpose- Therapeutic strategies that capitalize on the intrinsic capacity for neurological recovery early poststroke to improve locomotion are uncertain. Emerging data suggest that task-specific stepping practice provided at higher cardiovascular intensities may be critical dosage parameters that could maximize locomotor recovery. The purpose of this investigation was to determine the comparative effectiveness of providing high-intensity training on locomotor capacity early poststroke as compared with usual care. Methods- A quasi-experimental design was used to compare changes in stepping activity (StepWatch), walking, and balance outcomes during usual care (n=56) versus high-intensity stepping intervention (n=54) in inpatient stroke patients. Primary outcomes assessed weekly included self-selected and fastest gait speed, 6-minute walk test, and the Berg Balance Scale, with secondary outcomes of Swedish Postural Assessment Scale for Stroke-Norwegian version, Functional Ambulation Category, 30-s sit-to-stand, strength (average manual muscle testing), and Barthel Index. Regression analyses identified relationships between demographics, baseline function, and training activities (steps per day; duration achieved, 70%-85% maximum heart rates) and primary outcomes at discharge. Results- Following implementation of high-intensity stepping, average steps per day (5777±2784) were significantly greater than during usual care (3917±2656; P <0.001). Statistically different and clinically meaningful changes in self-selected speed (0.39±0.28 versus 0.16±0.26 m/s) and fastest gait speed (0.47±0.41 versus 0.17±0.38 m/s; both P <0.001) were observed following high-intensity interventions versus usual care and at every assessment throughout the length of stay. Changes in Berg Balance Scale and 6-minute walk test were also statistically and clinically different between groups, while secondary measures of Functional Ambulation Category and strength were also different at discharge. Primary predictors of improved walking capacity were steps per day, baseline impairments, and age. Conclusions- Provision of high-intensity stepping training applied during inpatient rehabilitation resulted in significantly greater walking and balance outcomes. This training paradigm should be further tested in other contexts to determine the generalizability to real-world and community settings.",2020,"Following implementation of high-intensity stepping, average steps per day (5777±2784) were significantly greater than during usual care (3917±2656; P <0.001).",['inpatient stroke patients'],"['Methods', 'usual care (n=56) versus high-intensity stepping intervention', ' and Purpose', 'High-Intensity Stepping Training', 'high-intensity training', 'high-intensity stepping training']","['walking and balance outcomes', 'fastest gait speed', 'walking capacity', 'Changes in Berg Balance Scale and 6-minute walk test', 'Functional Ambulation Category and strength', 'stepping activity (StepWatch), walking, and balance outcomes', 'weekly included self-selected and fastest gait speed, 6-minute walk test, and the Berg Balance Scale, with secondary outcomes of Swedish Postural Assessment Scale for Stroke-Norwegian version, Functional Ambulation Category, 30-s sit-to-stand, strength (average manual muscle testing), and Barthel Index']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",,0.0268686,"Following implementation of high-intensity stepping, average steps per day (5777±2784) were significantly greater than during usual care (3917±2656; P <0.001).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Moore', 'Affiliation': 'From the Regional Center of Knowledge Translation in Rehabilitation, Sunnaas Rehabilitation Hospital, Oslo/Nesodden, Norway (J.L.M.).'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Nordvik', 'Affiliation': 'CatoSenteret Rehabilitation Hospital, Son, Norway (J.E.N.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Erichsen', 'Affiliation': 'Section of Physiotherapy, Department of Medicine, Oslo University Hospital, Norway (A.E., E.B.).'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Rosseland', 'Affiliation': 'City of Oslo, Reinforced Interdisciplinary Rehabilitation Aker, Norway (I.R.).'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bø', 'Affiliation': 'Section of Physiotherapy, Department of Medicine, Oslo University Hospital, Norway (A.E., E.B.).'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Indiana University, Indianapolis (T.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027450'] 3500,31433259,A Smartphone App to Facilitate Remote Patient-Provider Communication in Hearing Health Care: Usability and Effect on Hearing Aid Outcomes.,"Background: Patients often need multiple fine-tuning appointments with their hearing health care provider to achieve satisfactory hearing aid outcomes. A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. Introduction: We assessed the usability of ReSound Assist™, (ReSound America, Bloomington, MN) the remote communication feature of a hearing aid app, and investigated whether hearing aid outcomes are influenced by app-based versus in-person patient-provider communication. Materials and Methods: Thirty adults were fit bilaterally with hearing aids and randomized to intervention and control groups. During a 6-week field trial, participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control). Usability of ReSound Assist was assessed with a questionnaire and interview. Hearing aid performance, benefit, satisfaction, and daily usage were compared for both groups. Results: ReSound Assist was rated as highly usable. Participants identified specific aspects of effectiveness and efficiency that could be improved. Similar problems were reported by intervention and control participants regardless of communication mode (app-based vs. in-person). However, almost half the requests received via ReSound Assist were for problems that required advice from the provider or physical modifications to the hearing aids rather than fine-tuning, highlighting the continued importance of in-person hearing health care. There was no significant difference in hearing aid outcomes between intervention and control participants. Conclusions: Apps enabling remote patient-provider communication are a viable method for hearing aid users to seek and receive help with hearing aid problems that can be addressed through fine-tuning.",2020,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. ,"['participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control', 'Thirty adults']",[],"['Hearing aid performance, benefit, satisfaction, and daily usage', 'hearing aid outcomes']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1272118', 'cui_str': 'Hearing aid problem'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",30.0,0.033924,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. ,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Convery', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Keidser', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'McLelland', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Groth', 'Affiliation': 'GN Hearing, Glenview, Illinois, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0109'] 3501,31376950,Service through surgery: A quasi-experimental comparison study on the impact of a preclinical seminar course on diverse mentorship and attitudes towards the underserved.,"BACKGROUND Increased surgical workforce diversity diminishes health disparities. METHODS Researchers recruited and nonrandomly enrolled participants into intervention and comparison groups for a quasi-experimental study of the impact of a seminar course on student exposure to diverse mentorship and service through surgery. All metrics were analyzed with chi-squared and paired t-tests. RESULTS 109 students participated (34 intervention, 75 comparison). There were significant differences in the percentage of participants that newly met a surgeon of their race (intervention, comparison: 100%, 25%), their race and gender (80%, 21%), their religion (23%, 9%), and who completed health disparities research (90%, 45%, p-value for all <0.05). There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. CONCLUSIONS This preclinical surgery seminar course increased exposure of underrepresented students to surgeons from diverse backgrounds and may impact student attitudes towards the underserved. This class represents a replicable model for increasing mentorship.",2020,"There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. ","['diverse mentorship and attitudes towards the underserved', 'Researchers recruited and nonrandomly enrolled participants into intervention and comparison groups for a quasi-experimental study of the impact of a seminar course on student exposure to diverse mentorship and service through surgery', 'Service through surgery', '109 students participated (34 intervention, 75 comparison']",[],['completed health disparities research'],"[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}]",75.0,0.0238153,"There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. ","[{'ForeName': 'Jecca Rhea', 'Initials': 'JR', 'LastName': 'Steinberg', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: jeccasteinberg@gmail.com.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Bryant', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: tsbryant@stanford.edu.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Carroll', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: annac12@stanford.edu.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Marin-Nevarez', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: pmarinne@stanford.edu.'}, {'ForeName': 'Edmund W', 'Initials': 'EW', 'LastName': 'Lee', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA; Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: EdmundLee12@gmail.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA; Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: tnanders@stanford.edu.'}, {'ForeName': 'Sylvia Bereknyei', 'Initials': 'SB', 'LastName': 'Merrell', 'Affiliation': 'Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA; Stanford-Surgery Policy Improvement Research and Education Center (S-SPIRE), Stanford Department of Surgery, 1070 Arastradero Road, Palo Alto, CA, 94304, USA. Electronic address: sylviab@stanford.edu.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Lau', 'Affiliation': 'Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: jnlau@stanford.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.07.031'] 3502,31356810,Use of an Ultrathin vs Thin Bronchoscope for Peripheral Pulmonary Lesions: A Randomized Trial.,"BACKGROUND When evaluating peripheral pulmonary lesions, a 3.0-mm ultrathin bronchoscope (UTB) with a 1.7-mm working channel is advantageous regarding good access to the peripheral airway, whereas a 4.0-mm thin bronchoscope provides a larger 2.0-mm working channel, which allows the use of various instruments including a guide sheath (GS), larger forceps, and an aspiration needle. This study compared multimodal bronchoscopy using a UTB and a thin bronchoscope with multiple sampling methods for the diagnosis of peripheral pulmonary lesions. METHODS Patients with peripheral pulmonary lesions ≤ 30 mm in diameter were recruited and randomized to undergo endobronchial ultrasonography, virtual bronchoscopy, and fluoroscopy-guided bronchoscopy using a 3.0-mm UTB (UTB group) or a 4.0-mm thin bronchoscope (thin bronchoscope group). In the thin bronchoscope group, the use of small forceps with a GS or standard forceps without the GS was permitted. In addition, needle aspiration was performed for lesions into which an ultrasound probe could not be inserted. RESULTS A total of 360 patients were enrolled, and 356 were included in the analyses (median largest lesional diameter, 19 mm). The overall diagnostic yield was significantly higher in the UTB group than in the thin bronchoscope group (70.1% vs 58.7%, respectively; P = .027). The procedure duration was significantly shorter in the UTB group (median, 24.8 vs 26.8 min, respectively; P = .008). The complication rates were 2.8% and 4.5%, respectively (P = .574). CONCLUSIONS Multimodal bronchoscopy using a UTB afforded a higher diagnostic yield than that using a thin bronchoscope in the diagnosis of small peripheral pulmonary lesions. TRIAL REGISTRY UMIN Clinical Trials Registry; No.: UMIN000010133; URL: https://www.umin.ac.jp/ctr/.",2019,"The complication rates were 2.8% and 4.5%, respectively (P = .574). ","['A total of 360 patients were enrolled, and 356 were included in the analyses (median largest lesional diameter, 19\xa0mm', 'Patients with peripheral pulmonary lesions\xa0≤ 30\xa0mm in diameter', 'Peripheral Pulmonary Lesions']","['Ultrathin vs\xa0Thin Bronchoscope', 'endobronchial ultrasonography, virtual bronchoscopy, and fluoroscopy-guided bronchoscopy using a 3.0-mm UTB (UTB group) or a 4.0-mm thin bronchoscope (thin bronchoscope group', 'ultrathin bronchoscope (UTB', 'multimodal bronchoscopy using a UTB and a thin bronchoscope with multiple sampling methods']","['procedure duration', 'complication rates', 'overall diagnostic yield']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0450396', 'cui_str': '30mm (qualifier value)'}]","[{'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",360.0,0.0909344,"The complication rates were 2.8% and 4.5%, respectively (P = .574). ","[{'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Oki', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Asano', 'Affiliation': 'Department of Pulmonary Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'Chiyoe', 'Initials': 'C', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Kogure', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Tsuzuku', 'Affiliation': 'Department of Pulmonary Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan. Electronic address: masahideo@aol.com.'}]",Chest,['10.1016/j.chest.2019.06.038'] 3503,31446581,Comparison of the effects of 10.6-μm infrared laser and traditional moxibustion in the treatment of knee osteoarthritis.,"Based on two separate randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion in treating knee osteoarthritis (OA), we did an indirect and preliminary comparison of the effects of the 10.6-μm laser moxibustion with the traditional moxibustion for knee osteoarthritis. The objective was to see whether the laser moxibustion is non-inferior to the traditional moxibustion in alleviating symptoms of knee osteoarthritis such as pain, stiffness, and joint dysfunction as well as improving quality of life for the patients with knee osteoarthritis, and whether a further RCT directly comparing the laser and traditional moxibustion is necessary. Pooled data from two RCTs in patients with knee osteoarthritis, trial ISRCTN68475405 and trial ISRCTN26065334, were used. In the two RCTs, the eligibility criteria were almost identical, the treatment procedure (i.e., sessions, duration, and points) were similar, and the outcome measurements (i.e., WOMAC for symptoms and SF-36 for quality of life) were the same. The double robustness method was used for the WOMAC scale and the SF-36 endpoints to detect the difference between traditional and laser moxibustion. The analysis comprised 55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group). Demographic characteristics and course of disease were similar between the two groups. Causal inference, using the doubly robust estimating approach to correct for bias due to baseline differences, showed that there was no statistically significant difference in the WOMAC pain, stiffness, and physical function between the two treatments at midterm, end of treatment, and 4 weeks after the end of treatment (P > 0.05). The exception was that there was statistically significantly more benefit associated with laser moxibustion compared with traditional moxibustion in physical function at the follow-up of 4 weeks after the end of treatment (P=0.006). There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002). The benefits of 10.6-μm infrared laser moxibustion and the traditional moxibustion for knee osteoarthritis were comparable in pain, stiffness, physical dysfunction, and in most of the quality of life subdimensions. The laser moxibustion might be more beneficial in terms of physical function, body pain, and mental health in the long term. RCTs directly comparing 10.6-μm laser moxibustion with traditional moxibustion are warranted.",2020,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","['knee osteoarthritis (OA', '55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group', 'patients with knee osteoarthritis', 'knee osteoarthritis']","['10.6-μm infrared laser and traditional moxibustion', 'laser moxibustion', '10.6-μm laser moxibustion with the traditional moxibustion', 'traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion', '10.6-μm infrared laser moxibustion']","['most SF-36 endpoints', 'pain, stiffness, physical dysfunction', 'physical function, body pain, and mental health', 'Demographic characteristics and course of disease', 'WOMAC pain, stiffness, and physical function', 'WOMAC scale', 'physical function', 'WOMAC for symptoms and SF-36 for quality of life', 'physical functioning (PF), mental health (MH), and bodily pain (BP']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",,0.0449206,"There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. cheng_ker@hotmail.com.'}, {'ForeName': 'Ming T', 'Initials': 'MT', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Bioinformatics & Biomathematics, Georgetown University Medical Center, Washington, D.C., 20057, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Zouqin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong New Area Hospital of Traditional Chinese Medicine, Shanghai, 201299, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Zhongshan Hospital of Zhejiang Province, Hangzhou, 310005, Zhejiang Province, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Haimeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, 201203, China. sxy1@shutcm.edu.cn.'}]",Lasers in medical science,['10.1007/s10103-019-02863-9'] 3504,31371432,"The Impact of Sotagliflozin on Renal Function, Albuminuria, Blood Pressure, and Hematocrit in Adults With Type 1 Diabetes.","OBJECTIVE In people with type 2 diabetes, sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce cardiovascular risk and progression of diabetic kidney disease. Our aim was to determine whether sotagliflozin (SOTA), a dual SGLT1i and SGLT2i, had favorable effects on clinical biomarkers suggestive of kidney protection in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In this 52-week pooled analysis, 1,575 adults enrolled in the inTandem1 and inTandem2 trials were randomized to SOTA 200 mg, 400 mg, or placebo in addition to optimized insulin therapy. Changes in cardiorenal biomarkers were assessed. RESULTS At 52 weeks, in response to SOTA 200 and 400 mg, the placebo-corrected least squares mean change from baseline in estimated glomerular filtration rate was -2.0 mL/min/1.73 m 2 ( P = 0.010) and -0.5 mL/min/1.73 m 2 ( P = 0.52), respectively. Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008). In participants with baseline urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g, UACR decreased by 23.7% ( P = 0.054) and 18.3% ( P = 0.18) for SOTA 200 and SOTA 400 mg, respectively, versus placebo. Increases in serum albumin and hematocrit and reductions in uric acid were observed throughout 52 weeks with both SOTA doses. CONCLUSIONS SOTA was associated with short- and long-term renal hemodynamic changes, which were similar to those seen with SGLT2i in type 2 diabetes. Further investigation around cardiorenal effects of SOTA in people with type 1 diabetes is justified.",2019,Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes', '1,575 adults enrolled in the inTandem1 and inTandem2 trials', 'people with type 1 diabetes', 'people with type 2 diabetes']","['SOTA', 'Sotagliflozin', 'placebo in addition to optimized insulin therapy', 'placebo', 'sotagliflozin (SOTA', 'sodium-glucose cotransporter 2 inhibitors (SGLT2i']","['glomerular filtration rate', 'UACR', 'diastolic blood pressure', 'Renal Function, Albuminuria, Blood Pressure, and Hematocrit', 'serum albumin and hematocrit and reductions in uric acid', 'Systolic blood pressure difference', 'short- and long-term renal hemodynamic changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3896939'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1575.0,0.328799,Systolic blood pressure difference was -2.9 and -3.6 mmHg ( P < 0.0001 for both); diastolic blood pressure changed by -1.4 ( P = 0.0033) and -1.6 mmHg ( P = 0.0008).,"[{'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Internal Medicine, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': 'Division of Nephrology, Department of Medicine, and Section of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Powell', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'de Cassia Castro', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Ping Stella', 'Initials': 'PS', 'LastName': 'Wang', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, University of Toronto, Toronto, Canada david.cherney@uhn.ca.'}]",Diabetes care,['10.2337/dc19-0937'] 3505,30613992,Effect of Early Parenteral Nutrition Discontinuation on Time to Regain Birth Weight in Very Low Birth Weight Infants: A Randomized Controlled Trial.,"BACKGROUND Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants. METHODS In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight. RESULTS The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008). CONCLUSIONS In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g.",2019,"Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01).","['A total of 139 patients were enrolled; 69 and 70 patients', 'VLBW infants', 'infants <1000', 'Very Low Birth Weight Infants', 'Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion', 'Infants with major congenital anomalies']","['Peripherally inserted central catheters (PICCs', 'Early Parenteral Nutrition Discontinuation', 'PICC removal and PN discontinuation']","['mean difference in time (days) to regain birth weight', 'early PICC removal', 'Time to Regain Birth Weight', 'birth weight', 'time to regain birth weight']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}]","[{'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]",139.0,0.331403,"Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Perrem', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Semberova', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Kieran', 'Affiliation': 'National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Colm P F', 'Initials': 'CPF', 'LastName': ""O'Donnell"", 'Affiliation': 'National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Martin John', 'Initials': 'MJ', 'LastName': 'White', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Miletin', 'Affiliation': 'Coombe Women and Infants University Hospital, Dublin, Ireland.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1502'] 3506,30079775,Effect of a Diabetes Self-Efficacy Enhancing Program on Older Adults With Type 2 Diabetes: A Randomized Controlled Trial.,"This randomized controlled trial examined the effect of a diabetes self-efficacy enhancing program (DSEEP) on older adults with type 2 diabetes. The 8-week DSEEP consisted of a guidebook on diabetes self-care, a 1-day workshop, and fortnightly follow-up telephone calls. In total, 113 participants (56 in intervention group and 57 in control group) completed the study. Data were collected at baseline and at 8 weeks from the baseline. Outcome measures included self-efficacy, diabetes self-care activities, health-related quality of life, glycated hemoglobin (HbA1c) and unplanned health care service usage. Compared with participants in the control group, those who received DSEEP had significantly higher increase in self-efficacy and diabetes self-care activities, lower HbA1c, and lesser unplanned health service usage. However, there was no significant difference in health-related quality of life between the two groups. The DSEEP increased self-efficacy, which successfully enhanced self-care activities and reduced HbA1c.",2020,"Compared with participants in the control group, those who received DSEEP had significantly higher increase in self-efficacy and diabetes self-care activities, lower HbA1c, and lesser unplanned health service usage.","['Older Adults With Type', '113 participants (56 in intervention group and 57 in control group) completed the study', '2 Diabetes', 'older adults with type 2 diabetes']","['Diabetes Self-Efficacy Enhancing Program', 'diabetes self-efficacy enhancing program (DSEEP', 'DSEEP']","['self-care activities and reduced HbA1c', 'self-efficacy and diabetes self-care activities, lower HbA1c, and lesser unplanned health service usage', 'self-efficacy, diabetes self-care activities, health-related quality of life, glycated hemoglobin (HbA1c) and unplanned health care service usage', 'health-related quality of life', 'self-efficacy']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]",113.0,0.0308771,"Compared with participants in the control group, those who received DSEEP had significantly higher increase in self-efficacy and diabetes self-care activities, lower HbA1c, and lesser unplanned health service usage.","[{'ForeName': 'Cherry Chay Lee', 'Initials': 'CCL', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Karis Kin Fong', 'Initials': 'KKF', 'LastName': 'Cheng', 'Affiliation': 'National University of Singapore, Singapore.'}, {'ForeName': 'Siew Wai', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Holroyd', 'Affiliation': 'Auckland University of Technology, New Zealand.'}, {'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National University of Singapore, Singapore.'}]",Clinical nursing research,['10.1177/1054773818792480'] 3507,31654697,Brain functional connectivity after cognitive-bias modification and behavioral changes in abstinent alcohol-use disorder patients.,"The use of the cognitive-bias modification (CBM) method has emerged as a therapeutic complement in the treatment of alcoholism, producing changes at behavioral and brain level. Nevertheless, the impact of the CBM procedure could be improved by the memory retrieval-extinction process (REP). Different studies have demonstrated that the retrieval of drug memories before extinction training later reduced the reinstatement of drug-seeking behavior. The main aim of this work was to study the effect of the CBM procedure itself, as well as in combination with the activation of alcohol-related memories, on the brain oscillatory activity of abstinent patients with alcohol-use disorder. The study sample comprised 33 patients divided into three groups: A-CBM (alcohol-related memory activation + CBM), N-CBM (neutral memory activation + CBM) and N-INT (no-intervention) groups. A resting-state EEG was obtained before and after each protocol, along with the assessment of the automatic action tendencies. A-CBM group showed a general alpha synchronization increase after the protocol, while the other groups did not show any significant change. Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli. The alpha phase synchronization increase could be the neural manifestation of the conditioning produced between the alcohol-related stimuli and the automatic avoidance response. Moreover, the activation of the alcohol-related memories favors this conditioning with those alcohol-related stimuli associated with the activated memories, because it increases their threat level for the abstinence maintenance.",2020,"Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli.","['abstinent alcohol-use disorder patients', '33 patients divided into three groups: A', 'abstinent patients with alcohol-use disorder']","['CBM (alcohol-related memory activation\u202f+\u202fCBM), N-CBM (neutral memory activation\u202f+\u202fCBM) and N-INT (no-intervention', 'cognitive-bias modification (CBM']","['general alpha synchronization increase', 'higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli', 'automatic action tendencies']","[{'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]",,0.0159507,"Besides, A-CBM group showed significant intra and inter-group differences in the automatic action tendencies after the protocol, reflected in higher avoidance bias toward appetitive, aversive and without context alcohol-related stimuli.","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Martínez-Maldonado', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain. Electronic address: andresmartinezmaldonado.imas12@h12o.es.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jurado-Barba', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sion', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Domínguez-Centeno', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Castillo-Parra', 'Affiliation': 'Psychology Department, Education and Health Science Faculty, Camilo José Cela University, Villafranca del Castillo Urb., Castillo de Alarcón St., 49, 28692 Villanueva de la Cañada, Madrid, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Prieto-Montalvo', 'Affiliation': 'Department of Clinical Neurophysiology, Hospital Gregorio Marañon, Dr Esquerdo St., 46, 28007 Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rubio', 'Affiliation': 'Biomedical Research Institute Hospital 12 de Octubre, Cordoba Ave., s/n, 28041 Madrid, Spain; Medicine Faculty, Complutense de Madrid University, Ramón y Cajal Sq., s/n, 28040 Madrid, Spain; Addictive Disorders Network, Carlos III Institute, Sinesio Delgado St., 4, 28029 Madrid, Spain.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.10.004'] 3508,30721940,Falls After Hospital Discharge: A Randomized Clinical Trial of Individualized Multimodal Falls Prevention Education.,"BACKGROUND Older people are at high risk of falls after hospital discharge. The study aimed to evaluate the effect of providing individualized falls prevention education in addition to usual care on falls rates in older people after hospital discharge compared to providing a social intervention in addition to usual care. METHODS A randomized clinical trial at three hospitals in Western Australia: participants followed for 6 months after discharge. Baseline and outcomes measured by assessors masked to group allocation. Participants: aged 60 years and over, admitted for rehabilitation. Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10). Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist. Main outcomes: falls in the 6 months after discharge; proportion of participants sustaining one or more falls. RESULTS There were 382 (194 intervention; 188 control) participants (mean age 77.7 [SD 8.7] years). There were 378 falls (fall rate per 1,000 patient-days, 5.9 intervention; 5.9 control) reported by 164 (42.9%) participants in the 6 months following hospital discharge; 188 (49.7%) of these falls were injurious. There were no significant differences in falls rates between intervention and control groups: (adjusted IRR, 1.09; 95% CI [0.78 to 1.52]) or the proportion of participants who fell once or more (adjusted OR, 1.37; 95% CI [0.90 to 2.07]). CONCLUSIONS Providing individualized falls prevention education prior to discharge did not reduce falls at home after discharge. Further research is warranted to investigate how to reduce falls during this high-risk transition period.",2019,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)]. ","['older people after hospital discharge', 'Falls after hospital discharge', 'There were 382 (194 intervention; 188 control) participants [mean age 77.7 (SD 8.7) years', 'Eligibility included: cognitively able to undertake education (Abbreviated mental test score >7/10', 'Participants: aged 60 years and over, admitted for rehabilitation']","['social intervention', 'individualized multi-modal', 'individualized falls prevention education', 'Intervention: tailored education comprising patient video and workbook, structured discussion and goal setting led by trained therapist']","['discharge; proportion of participants sustaining one or more falls', 'falls rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2960765', 'cui_str': 'Abbreviated mental test score'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",,0.217539,"There were no significant differences in falls rates between intervention and control groups: [adjusted IRR, 1.09; 95% CI (0.78 to 1.52)] or the proportion of participants who fell once or more [adjusted OR, 1.37; 95% CI (0.90 to 2.07)]. ","[{'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': 'Healthscope and La Trobe Centre for Sport and Exercise Medicine Research, La Trobe University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Etherton-Beer', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, Geriatric Research Education and Clinical Center (GRECC), Gainesville, Florida.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health & Ageing, Medical School, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Waldron', 'Affiliation': 'Department of Aged Care and Rehabilitation, Armadale Kelmscott Memorial Hospital, East Metropolitan Health Service, Armadale, Western Australia, Australia.'}, {'ForeName': 'Den-Ching A', 'Initials': 'DA', 'LastName': 'Lee', 'Affiliation': 'School of Primary and Allied Health Care, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Francis-Coad', 'Affiliation': 'School of Physiotherapy, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Boudville', 'Affiliation': 'Department of Aged Care and Rehabilitation, St John of God Midland Public and Private Hospital, Midland, Western Australia, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz026'] 3509,31690831,Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16).,"BACKGROUND The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. METHODS A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m 2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m 2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. RESULTS The median number of previous anti-HER2 therapies was 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58). Toxicity profiles were similar in both arms and all were manageable. CONCLUSIONS Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov number NCT01730677.",2019,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","['patients progressed on both trastuzumab and lapatinib treatments', 'A total of 149 patients', 'patients with HER2\u2009+\u2009metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16']","['Lapatinib plus vinorelbine', 'lapatinib with vinorelbine (LV) (n\u2009=\u200975; lapatinib, 1000\u2009mg daily; vinorelbine 20\u2009mg/m 2 D1, D8 q3w) or vinorelbine (V', 'lapatinib and vinorelbine vs vinorelbine', 'vinorelbine', 'lapatinib plus vinorelbine']","['ORR', 'median number of previous anti-HER2 therapies', 'Toxicity profiles', 'progression-free survival (PFS) rate', 'PFS and OS', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",149.0,0.125427,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","[{'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. parkih@ncc.re.kr.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University, College of Medicine, Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Yu Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal medicine, Seoul National University Bundang Hospital, Bundang, Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Dong-A University, College of Medicine, Busan, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yee Soo', 'Initials': 'YS', 'LastName': 'Chae', 'Affiliation': 'Kyungpook National University, College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Division of Oncology/Hematology, Korea University, Seoul, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute & Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-019-0618-z'] 3510,30621718,"The effectiveness of a multidisciplinary intervention strategy for the treatment of symptomatic joint hypermobility in childhood: a randomised, single Centre parallel group trial (The Bendy Study).","INTRODUCTION Joint hypermobility is common in childhood and can be associated with musculoskeletal pain and dysfunction. Current management is delivered by a multidisciplinary team, but evidence of effectiveness is limited. This clinical trial aimed to determine whether a structured multidisciplinary, multisite intervention resulted in improved clinical outcomes compared with standard care. METHOD A prospective randomised, single centre parallel group trial comparing an 8-week individualised multidisciplinary intervention programme (bespoke physiotherapy and occupational therapy in the clinical, home and school environment) with current standard management (advice, information and therapy referral if deemed necessary). The primary endpoint of the study was between group difference in child reported pain from baseline to 12 months as assessed using the Wong Baker faces pain scale. Secondary endpoints were parent reported pain (100 mm visual analogue scale), parent reported function (child health assessment questionnaire), child reported quality of life (child health utility 9-dimensional assessment), coordination (movement assessment battery for children version 2) and grip strength (handheld dynamometer). RESULTS 119 children aged 5 to 16 years, with symptomatic hypermobility were randomised to receive an individualised multidisciplinary intervention (I) (n = 59) or standard management (S) (n = 60). Of these, 105 completed follow up at 12 months. No additional significant benefit could be shown from the intervention compared to standard management. However, there was a statistically significant improvement in child and parent reported pain, coordination and grip strength in both groups. The response was independent of the degree of hypermobility. CONCLUSION This is the first randomised controlled trial to compare a structured multidisciplinary, multisite intervention with standard care in symptomatic childhood hypermobility. For the majority, the provision of education and positive interventions aimed at promoting healthy exercise and self-management was associated with significant benefit without the need for more complex interventions. TRIAL REGISTRATION The trial was registered prospectively with the national database at the Clinical Research Network (UKCRN Portfolio 9366). The trial was registered retrospectively with ISRCTN ( ISRCTN86573140 ).",2019,"For the majority, the provision of education and positive interventions aimed at promoting healthy exercise and self-management was associated with significant benefit without the need for more complex interventions. ","['119 children aged 5 to 16\u2009years, with symptomatic hypermobility', 'symptomatic childhood hypermobility', 'symptomatic joint hypermobility in childhood']","['individualised multidisciplinary intervention programme (bespoke physiotherapy and occupational therapy', 'multidisciplinary intervention strategy', 'individualised multidisciplinary intervention (I) ']","['child reported pain', 'Wong Baker faces pain scale', 'pain (100\u2009mm visual analogue scale), parent reported function (child health assessment questionnaire), child reported quality of life (child health utility 9-dimensional assessment), coordination (movement assessment battery for children version 2) and grip strength (handheld dynamometer', 'pain, coordination and grip strength']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0549185', 'cui_str': 'Hypermobility (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0086437', 'cui_str': 'Hypermobility, Joint'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}]",119.0,0.165035,"For the majority, the provision of education and positive interventions aimed at promoting healthy exercise and self-management was associated with significant benefit without the need for more complex interventions. ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bale', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK. peterbale@doctors.net.uk.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Easton', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Bacon', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Jerman', 'Affiliation': 'Norfolk Community Health and Care NHS Trust, Norwich, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Watts', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Armon', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'MacGregor', 'Affiliation': 'Norfolk and Norwich University Hospital NHS Trust, Colney Lane, Norwich, UK.'}]",Pediatric rheumatology online journal,['10.1186/s12969-018-0298-x'] 3511,30776393,An examination of the moderating effects of neurophysiology on treatment outcomes from cognitive training in schizophrenia-spectrum disorders.,"BACKGROUND Impairments in neurocognition and community functioning are core features of schizophrenia and cognitive training techniques have been developed with the aim of improving these impairments. While cognitive training has produced reliable improvements in neurocognition and functioning, little is known about factors that moderate treatment response. Electroencephalographic (EEG) measures provide a neurophysiological indicator of cognitive functions that may moderate treatment outcomes from cognitive training. METHODS Data from a clinical trial comparing two cognitive training approaches in schizophrenia-spectrum disorders were utilized in the current report. Cluster analysis was conducted to identify participant clusters based on baseline P300, mismatch negativity (MMN), and theta power during an n-back task, and the EEG measures were also examined as continuous predictors of treatment response. RESULTS Three clusters were identified based on the baseline EEG variables; however, there were no significant differences in treatment response across the three clusters. Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment. None of the EEG measures were significantly associated with treatment outcomes in specific cognitive domains or community functioning. Change in EEG measures from baseline to post-treatment was not significantly associated with durability of cognitive or functional change at 12-week follow-up. CONCLUSIONS Clusters derived from the EEG measures were not significantly associated with either neurocognitive or functional outcomes. P300 and n-back theta power may be associated with learning-related processes, which are important for acquisition and retention of skills during cognitive training programs. Future research should aim to identify at an individual level who is likely to respond to specific forms of cognitive enhancement.",2020,Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment.,['schizophrenia-spectrum disorders'],"['neurophysiology', 'cognitive training approaches', 'Electroencephalographic (EEG', 'cognitive training']","['durability of cognitive or functional change', 'cognitive composite score', 'baseline P300, mismatch negativity (MMN), and theta power during an n-back task, and the EEG measures', 'Change in EEG measures', 'Higher P300 amplitude and theta power', 'specific cognitive domains or community functioning']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3) (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",3.0,0.04658,Higher P300 amplitude and theta power during the n-back at baseline were significantly associated with greater improvements in a cognitive composite score post-treatment.,"[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Best', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Milanovic', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Shamblaw', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Muere', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Lambe', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Hong', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mashal K', 'Initials': 'MK', 'LastName': 'Haque', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, Ontario, Canada; Centre for Addiction and Mental Health, Toronto, Ontario, Canada. Electronic address: bowiec@queensu.ca.""}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.02.004'] 3512,30651294,"Participation in Cervical Screening by Self-collection, Pap, or a Choice of Either in Brazil.","Most cervical cancers occur in women who do not participate in cervical-cancer screening. We therefore evaluated adherence to screening for clinic-based Pap testing, self-collected sampling for HPV testing, and choice of the 2 among 483 unscreened/underscreened women in Brazil. Three public Basic Health Units (BHU) were each randomly assigned to three arms: (i) Pap testing at the BHU ( N = 160), (ii) ""Self&HPV"" (self-collection for HPV testing) ( N = 161), and (iii) ""Choice"" between self-collection and HPV testing and Pap test at the local BHU ( N = 162). The theory-based (PEN-3 and Health Belief Model) intervention in all three arms was implemented by trained Community Health Workers (CHW) at participants' home. With the first invitation, 60.0% in the Pap arm, 95.1% [154 of 161 (95.7%) who selected Self&HPV and 0 of 1 (0.0%) who selected Pap] in the Choice arm, and 100% in the Self&HPV arm completed screening. By the second invitation to choose a method of screening in the Choice arm, 100% completed screening. After three invitations, 75.0% of women in the Pap arm completed screening. Adherence to screening differed by study arm ( P < 0.001). In conclusion, Self&HPV testing is a promising strategy for unscreened/underscreened women who are recalcitrant or unable to undergo clinic-based cervical screening to complement the screening modality used in the general population. In Brazil, where Pap testing is recommended for routine cervical screening, training CHWs in behavior change strategies and offering Self&HPV or Choice could greatly improve screening population coverage by reaching the unscreened/underscreened populations.",2019,Adherence to screening differed by study arm ( P < 0.001).,"['483 unscreened/underscreened women in Brazil', 'unscreened/underscreened women who are recalcitrant or unable to undergo clinic-based cervical screening', 'Three public Basic Health Units (BHU']","['Self&HPV"" (self-collection for HPV testing']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",[],,0.0260534,Adherence to screening differed by study arm ( P < 0.001).,"[{'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Castle', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York. castle.philip@gmail.com.'}, {'ForeName': 'Vânia R S', 'Initials': 'VRS', 'LastName': 'Silva', 'Affiliation': 'Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Marcia E L', 'Initials': 'MEL', 'LastName': 'Consolaro', 'Affiliation': 'Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Nádia', 'Initials': 'N', 'LastName': 'Kienen', 'Affiliation': 'Universidade Estadual de Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Bittencourt', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Pelloso', 'Affiliation': 'Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Partridge', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Pierz', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Dartibale', 'Affiliation': 'Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Nelson S', 'Initials': 'NS', 'LastName': 'Uchimura', 'Affiliation': 'Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0419'] 3513,31034730,Ultrasound-guided quadratus lumborum block compared to caudal ropivacaine/morphine in children undergoing surgery for vesicoureteric reflex.,"BACKGROUND Ultrasound-guided quadratus lumborum block is a regional anesthetic technique which can provide perioperative analgesia for all age groups, including pediatric patients undergoing abdominal surgery. We hypothesized that the quadratus lumborum block would be as efficacious as a caudal block, the gold standard of pediatric lower abdominal regional anesthesia, in providing pain control after ureteral reimplantation but also have a longer duration. METHODS Forty-seven pediatric patients between the ages of 1 and 17 years undergoing bilateral ureteral reimplantation surgery via a low transverse incision were enrolled and randomized into the quadratus lumborum block and caudal block groups. All blocks were performed preoperatively under general anesthesia. We analyzed the following outcomes: the requirement for narcotic analgesics, pain score, episodes of emesis, and complications at 0, 4, 24, and 48 hours postoperatively. RESULTS The study included 44 patients after excluding three who were ineligible. The fentanyl requirement for postoperative rescue analgesia during the first 24 hours was significantly lower in the quadratus lumborum block group than in the caudal block group (median [interquartile range]: 0 [0-1] vs 3 [0-5], P = 0.016, 95% confidence intervals: -4 to 0) but not at 30 minutes, 4, or 48 hours. No significant difference was observed in the pain scores or the incidence of interventions to treat nausea and vomiting during the entire period. No postoperative complication was observed. CONCLUSION The quadratus lumborum block was more effective in reducing the postoperative opioid requirement for rescue analgesia during the initial 24 hours than caudal ropivacaine/morphine.",2019,No significant difference was observed in the pain scores or the incidence of interventions to treat nausea and vomiting during the entire period.,"['Forty-seven pediatric patients between the ages of 1 and 17\xa0years undergoing bilateral ureteral reimplantation surgery via a low transverse incision', 'pediatric patients undergoing abdominal surgery', 'children undergoing surgery for vesicoureteric reflex', '44 patients after excluding three who were ineligible']","['ropivacaine/morphine', 'Ultrasound-guided quadratus lumborum block', 'Ultrasound-guided quadratus lumborum block compared to caudal ropivacaine/morphine', 'quadratus lumborum block and caudal block groups']","['nausea and vomiting', 'postoperative complication', 'narcotic analgesics, pain score, episodes of emesis, and complications', 'pain scores', 'postoperative rescue analgesia']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision (procedure)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0027409', 'cui_str': 'Narcotic Analgesics'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",44.0,0.106506,No significant difference was observed in the pain scores or the incidence of interventions to treat nausea and vomiting during the entire period.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': ""Department of Anesthesiology, Tokyo Metropolitan Children's Medical Center, Fuchu, Tokyo, Japan.""}]",Paediatric anaesthesia,['10.1111/pan.13650'] 3514,31034728,The impact of simulation-based medical education on resident management of emergencies in pediatric anesthesiology.,"BACKGROUND Resident education in pediatric anesthesiology is challenging. Traditional curricula for anesthesiology residency programs have included a combination of didactic lectures and mentored clinical service, which can be variable. Limited pediatric medical knowledge, technical inexperience, and heightened resident anxiety further challenge patient care. We developed a pediatric anesthesia simulation-based curriculum to address crises related to hypoxemia and dysrhythmia management in the operating room as an adjunct to traditional didactic and clinical experiences. AIMS The primary objective of this trial was to evaluate the impact of a simulation curriculum designed for anesthesiology residents on their performance during the management of crises in the pediatric operating room. A secondary objective was to compare the retention of learned knowledge by assessment at the eight-week time point during the rotation. METHODS In this prospective, observational trial 30 residents were randomized to receive simulation-based education on four perioperative crises (Laryngospasm, Bronchospasm, Supraventricular Tachycardia (SVT), and Bradycardia) during the first week (Group A) or fifth week (Group B) of an eight-week rotation. Assessment sessions that included two scenarios (Laryngospasm, SVT) were performed in the first week, fifth week, and the eighth week of their rotation for all residents. The residents were assessed in real time and by video review using a 7-point checklist generated by a modified Delphi technique of senior pediatric anesthesiology faculty. RESULTS Residents in Group A showed improvement between the first week and fifth week assessment as well as between first week and eighth week assessments without decrement between the fifth week and eighth week assessments for both the laryngospasm and SVT scenarios. Residents in Group B showed improvement between the first week and eighth week assessments for both scenarios and between the fifth week and eighth week assessment for the SVT scenario. CONCLUSION This adjunctive simulation-based curriculum enhanced the learner's management of laryngospasm and SVT management and is a reasonable addition to didactic and clinical curricula for anesthesiology residents.",2019,"RESULTS Residents in Group A showed improvement between the first week and fifth week assessment as well as between first week and eighth week assessments without decrement between the fifth week and eighth week assessments for both the laryngospasm and SVT scenarios.","['emergencies in pediatric anesthesiology', 'anesthesiology residents on their performance during the management of crises in the pediatric operating room', '30 residents']","['simulation-based education on four perioperative crises (Laryngospasm, Bronchospasm, Supraventricular Tachycardia (SVT), and Bradycardia', 'simulation-based medical education']",['retention of learned knowledge'],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0013631', 'cui_str': 'Education, Medical'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",30.0,0.0250808,"RESULTS Residents in Group A showed improvement between the first week and fifth week assessment as well as between first week and eighth week assessments without decrement between the fifth week and eighth week assessments for both the laryngospasm and SVT scenarios.","[{'ForeName': 'Aditee P', 'Initials': 'AP', 'LastName': 'Ambardekar', 'Affiliation': 'Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical School, Dallas, Texas.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Lockman', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allan F', 'Initials': 'AF', 'LastName': 'Simpao', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Hales', 'Affiliation': ""Center for Simulation, Advanced Education, and Innovation, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Rodgers', 'Affiliation': 'Clinical Simulation Center, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Harshad G', 'Initials': 'HG', 'LastName': 'Gurnaney', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Paediatric anaesthesia,['10.1111/pan.13652'] 3515,31182338,Sitagliptin improves diastolic cardiac function but not cardiorespiratory fitness in adults with type 2 diabetes.,"BACKGROUND People with type 2 diabetes mellitus (T2D) have preclinical cardiac and vascular dysfunction associated with low cardiorespiratory fitness (CRF). This is especially concerning because CRF is a powerful predictor of cardiovascular mortality, a primary issue in T2D management. Glucagon-like pepetide-1 (GLP-1) augments cardiovascular function and our previous data in rodents demonstrate that potentiating the GLP-1 signal with a dipeptidyl peptidase-4 (DPP4) inhibitor augments CRF. Lacking are pharmacological treatments which can target T2D-specific physiological barriers to exercise to potentially permit adaptations necessary to improve CRF and thereby health outcomes in people with T2D. We therefore hypothesized that administration of a DPP4-inhibitor (sitagliptin) would improve CRF in adults with T2D. METHODS AND RESULTS Thirty-eight participants (64 ± 1 years; mean ± SE) with T2D were randomized in a double-blinded study to receive 100 mg/day sitagliptin, 2 mg/day glimepiride, or placebo for 3 months after baseline measurements. Fasting glucose decreased with both glimepiride and sitagliptin compared with placebo (P = 0.002). CRF did not change in any group (Placebo: Pre: 15.4 ± 0.9 vs. Post: 16.1 ± 1.1 ml/kg/min vs. Glimepiride: 18.5 ± 1.0 vs. 17.7 ± 1.2 ml/kg/min vs. Sitagliptin: 19.1 ± 1.2 vs. 18.3 ± 1.1 ml/kg/min; P = 0.3). Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment. CONCLUSIONS Three months of sitagliptin improved diastolic cardiac function, however, CRF did not change. These data suggest that targeting the physiological contributors to CRF with sitagliptin alone is not an adequate strategy to improve CRF in people with T2D. CLINICAL TRIALS REGISTRATION www.clinicaltrials.gov NCT01951339.",2019,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment. ","['Thirty-eight participants (64\u202f±\u202f1\u202fyears; mean\u202f±\u202fSE) with T2D', 'adults with type 2 diabetes', 'People with type 2 diabetes mellitus (T2D', 'people with T2D']","['Glimepiride', 'placebo', 'glimepiride', 'Sitagliptin', 'DPP4-inhibitor (sitagliptin', 'Glucagon-like pepetide-1', '100\u202fmg/day sitagliptin, 2\u202fmg/day glimepiride, or placebo']","['diastolic cardiac function', 'CRF', 'cardiac diastolic function', 'vascular function', 'Fasting glucose']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",,0.204482,"Sitagliptin improved measures of cardiac diastolic function, however, measures of vascular function did not change with any treatment. ","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Scalzo', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America. Electronic address: rebecca.scalzo@ucdenver.edu.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Rafferty', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schauer', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Amy G', 'Initials': 'AG', 'LastName': 'Huebschmann', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Division of Pediatric Endocrinology, University of Colorado School of Medicine, United States of America.""}, {'ForeName': 'Jane E B', 'Initials': 'JEB', 'LastName': 'Reusch', 'Affiliation': ""Division of Endocrinology, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America; Rocky Mountain Regional Veterans Administration Medical Center, United States of America.""}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Regensteiner', 'Affiliation': ""Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, United States of America; Center for Women's Health Research, Department of Medicine, University of Colorado School of Medicine, United States of America.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.05.002'] 3516,31563804,Positive urgency worsens the impact of normative feedback on 21st birthday drinking.,"BACKGROUND The 21st birthday is associated with more alcohol consumption and negative consequences than any other occasion. The current study investigated how positive urgency, the tendency to act rashly in response to positive emotions, influences 21st birthday drinking and the effectiveness of a single event text message intervention designed to reduce 21st birthday drinking and related negative consequences. METHODS Participants were 183 undergraduate students (69% female, 86% white) about to turn 21. Participants were randomly assigned to either a text message intervention or control condition. Those in the intervention condition received one text message the day before their 21st birthday that provided personalized normative feedback and one text message on the day of their 21st birthday. Participants reported actual alcohol consumption the day after their 21st birthday celebration. RESULTS Hierarchical linear regression found that, after controlling for sex, intervention condition, and planned drinking, positive urgency was associated with greater number of drinks (β = .15, p = .031) and drinking problems (β = .25, p = .001). A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]): At high levels of positive urgency, the intervention condition was associated with drinking more than planned, which significantly mediated the relationship between intervention and alcohol-related consequences; the mediation was not significant at mean or low levels of positive urgency. CONCLUSIONS These findings are the first to link positive urgency with 21st birthday drinking and to empirically demonstrate that positive urgency negatively impacts the effectiveness of an intervention aimed at reducing alcohol consumption.",2019,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","['Participants were 183 undergraduate students (69% female, 86% white) about to turn 21']",['text message intervention or control condition'],"['actual alcohol consumption', 'drinking problems']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0198354,"A moderated-mediation model was significant (B = 0.42, CI95 [.10, .76]):","[{'ForeName': 'Zachary T', 'Initials': 'ZT', 'LastName': 'Whitt', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States. Electronic address: zacwhitt@iu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States.'}, {'ForeName': 'Nichea', 'Initials': 'N', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'L A R', 'Initials': 'LAR', 'LastName': 'Stein', 'Affiliation': 'Brown University, Center for Alcohol and Addiction Studies, Providence, RI, United States; Department of Psychology, University of Rhode Island, Kingston, RI, United States; Rhode Island Training School, Department of Children, Youth and Families, Cranston, RI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Schick', 'Affiliation': 'Department of Psychology, University of Rhode Island, Kingston, RI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Cyders', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, Indianapolis, IN, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107559'] 3517,31776732,The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.,"OBJECTIVE To evaluate the efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for chemotherapy-induced nausea vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy (HEC). METHODS In this randomized, double-blind, placebo-controlled, crossover study, we randomly assigned chemotherapy-naïve patients receiving HEC to receive olanzapine or placebo in addition to ondansetron and dexamethasone. All subjects were crossed over to another treatment arm on second-cycle chemotherapy. The primary endpoint was complete response (CR) rate defined as no vomiting and no use of rescue drugs. RESULTS At the first cycle, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (68.7% vs. 25.0%, p < 0.001), acute phase (0-24 h) (75.0% vs. 31.2%, p < 0.001) and delayed phase (24-120 h) (68.7% vs. 43.7%, p = 0.038). After crossover, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (67.2% vs. 25.0%, p < 0.001), acute phase (71.9% vs. 32.8%, p < 0.001) and delayed phase (67.2% vs. 37.5%, p < 0.001). In crossover analysis, the olanzapine group had significantly lower mean nausea (1.28 vs. 3.05, p < 0.001) and fatigue (3.5 vs. 4.58, p < 0.001) scores but higher mean appetite (2.5 vs. 1.55, p = 0.003) and sleepiness (3.26 vs. 2.2, p < 0.001) scores. There were no grade 3 and 4 anti-emetic-drug-related toxicities. Mean QT interval changes did not different between two groups (-4.30 vs. -1.86, p = 0.69). CONCLUSION The addition of olanzapine to ondansetron and dexamethasone significantly improved CINV prevention and was safe in patients receiving HEC.",2020,"Mean QT interval changes did not different between two groups (-4.30 vs. -1.86, p = 0.69). ","['patients receiving highly emetogenic chemotherapy', 'naïve patients receiving HEC to receive', 'patients receiving highly emetogenic chemotherapy (HEC', 'patients receiving HEC']","['ondansetron and dexamethasone', 'chemotherapy', 'olanzapine', 'placebo', 'olanzapine or placebo', 'olanzapine to ondansetron and dexamethasone']","['nausea and vomiting', 'mean nausea', 'efficacy and safety', 'acute phase', 'grade 3 and 4 anti-emetic-drug-related toxicities', 'Mean QT interval changes', 'complete response (CR) rate defined as no vomiting and no use of rescue drugs', 'nausea vomiting (CINV) prevention', 'CINV prevention', 'sleepiness', 'fatigue', 'mean appetite']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.335667,"Mean QT interval changes did not different between two groups (-4.30 vs. -1.86, p = 0.69). ","[{'ForeName': 'Veerisa', 'Initials': 'V', 'LastName': 'Vimolchalao', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Siwat', 'Initials': 'S', 'LastName': 'Sakdejayont', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Ploytuangporn', 'Initials': 'P', 'LastName': 'Wongchanapai', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sukprakun', 'Affiliation': 'Oncology Section, Production Division, Pharmacy Department, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Pattama', 'Initials': 'P', 'LastName': 'Angspatt', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Wilai', 'Initials': 'W', 'LastName': 'Thawinwisan', 'Affiliation': 'Department of Nursing, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Piyachut', 'Initials': 'P', 'LastName': 'Chenaksara', 'Affiliation': 'Department of Nursing, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Virote', 'Initials': 'V', 'LastName': 'Sriuranpong', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Vinayanuwatikun', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Napa', 'Initials': 'N', 'LastName': 'Parinyanitikun', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand.'}, {'ForeName': 'Nattaya', 'Initials': 'N', 'LastName': 'Poovorawan', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Suebpong', 'Initials': 'S', 'LastName': 'Tanasanvimon', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand. surbpong@yahoo.com.'}]",International journal of clinical oncology,['10.1007/s10147-019-01570-3'] 3518,31375378,Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation.,"OBJECTIVE The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. METHODS We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. RESULTS In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. CONCLUSIONS The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.",2020,"At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08.","['patients with moderate ischemic mitral regurgitation randomized to', 'patients with moderate ischemic mitral regurgitation', 'moderate ischemic mitral regurgitation']","['coronary artery bypass grafting plus mitral valve repair', 'coronary artery bypass grafting plus mitral valve\xa0repair (n\xa0=\xa0150) or coronary artery bypass grafting alone', 'mitral valve repair to coronary artery bypass grafting', 'coronary artery bypass grafting alone', 'coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone']","['Cost-effectiveness', 'costs and quality-adjusted survival', 'death rate', 'survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years', 'quality-adjusted life years', 'incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0034380'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0789585,"At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08.","[{'ForeName': 'Bart S', 'Initials': 'BS', 'LastName': 'Ferket', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiac Surgery, MedStar Heart & Vascular Institute, Washington, DC; Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Voisine', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumonologie de Québec, Hôpital Laval, Québec, Quebec, Canada.'}, {'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hohmann', 'Affiliation': 'Center for Advanced Analytics, Vizient, Chicago, Ill.'}, {'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Chang', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Michler', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY.'}, {'ForeName': 'Gorav', 'Initials': 'G', 'LastName': 'Ailawadi', 'Affiliation': 'Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville, Va.'}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Perrault', 'Affiliation': 'Montréal Heart Institute, University of Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marissa A', 'Initials': 'MA', 'LastName': 'Miller', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Md.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Mick', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Acker', 'Affiliation': 'Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Judy W', 'Initials': 'JW', 'LastName': 'Hung', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, Mass.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Iraola', 'Affiliation': 'Cardiovascular Services, Suburban Hospital of Johns Hopkins Medicine, Bethesda, Md.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Gammie', 'Affiliation': 'Department of Surgery, Division of Cardiac Surgery, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Annetine C', 'Initials': 'AC', 'LastName': 'Gelijns', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: annetine.gelijns@mssm.edu.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': ""O'Gara"", 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.06.040'] 3519,31630538,Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial.,"BACKGROUND Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation (PVI) and minimize arrhythmia recurrence after atrial fibrillation (AF) ablation. METHODS We randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency ablation (CF-RF; n=115), 4-minute cryoballoon ablation (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116). Follow-up was 12 months. The primary outcome was time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any time. Secondary end points included freedom from symptomatic arrhythmia and AF burden. All patients received an implantable loop recorder. RESULTS One-year freedom from atrial tachyarrhythmia defined by continuous rhythm monitoring was 53.9%, 52.2%, and 51.7% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.87). One-year freedom from symptomatic atrial tachyarrhythmia defined by continuous rhythm monitoring was 79.1%, 78.2%, and 73.3% with CF-RF, Cryo-4, and Cryo-2, respectively ( P =0.26). Compared with the monitoring period before ablation, AF burden was reduced by a median of 99.3% (interquartile range, 67.8%-100.0%) with CF-RF, 99.9% (interquartile range, 65.3%-100.0%) with Cryo-4, and 98.4% (interquartile range, 56.2%-100.0%) with Cryo-2 ( P =0.36). Serious adverse events occurred in 3 patients (2.6%) in the CF-RF group, 6 patients (5.3%) in the Cryo-4 group, and 7 patients (6.0%) in the Cryo-2 group, with no significant difference between groups ( P =0.24). The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure ( P <0.001 vs cryoballoon groups). CONCLUSIONS In this multicenter, randomized, single-blinded trial, CF-RF and 2 different regimens of cryoballoon ablation resulted in no difference in 1-year efficacy, which was 53% by time to first recurrence but >98% burden reduction as assessed by continuous cardiac rhythm monitoring. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01913522.",2019,The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs. cryoballoon groups). ,['346 patients with drug-refractory paroxysmal AF to'],"['Cryoballoon or Radiofrequency Ablation', 'cryoballoon ablation', 'contact-force RF ablation', 'implantable loop recorder', 'contactforce guided RF ablation (CF-RF ablation, 115), 4-minute cryoballoon ablation (CRYO-4, 115), or 2-minute cryoballoon ablation']","['freedom from symptomatic arrhythmia, and AF burden', 'AF burden', 'time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia', 'repeat ablation procedure at any time', 'atrial tachyarrhythmia defined by continuous rhythm monitoring', 'procedure duration', 'Serious adverse events', 'symptomatic atrial tachyarrhythmia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C4552498', 'cui_str': 'Implantable loop recorder'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",346.0,0.267623,The CF-RF group had a significantly longer procedure duration but significantly shorter fluoroscopy exposure (P<0.001 vs. cryoballoon groups). ,"[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Canada (J.C., C.S.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dubuc', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, Canada (J.G.A., M.W.D., M.T.B.).'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Canada (A.V.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada (P.L.-S., A.S.L.T.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada (P.N.).'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Canada (M.B.-V.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Canada (J.S.).'}, {'ForeName': 'Iqwal', 'Initials': 'I', 'LastName': 'Mangat', 'Affiliation': ""Department of Medicine, St Michael's Hospital, Toronto, Canada (I.M.).""}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'University of Winnipeg, Canada (C.K.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Steinberg', 'Affiliation': 'Université Laval, Quebec City, Canada (J.C., C.S.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Bennett', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, Canada (J.G.A., M.W.D., M.T.B.).'}, {'ForeName': 'Anthony S L', 'Initials': 'ASL', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada (P.L.-S., A.S.L.T.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Canada (J.G.A., M.D., L.M., P.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042622'] 3520,31201146,The efficacy of a Persian herbal formulation on functional bloating: A double-blind randomized controlled trial.,"BACKGROUND Bloating is a common gastrointestinal complaint which is difficult to treat. OBJECTIVE This study investigated the efficacy and compliance of a formulation called KAASER comprised of Trachyspermum ammi (L.) Sprague seed, Zingiber officinale Roscoe. rhizome and Piper nigrum L. berry in the treatment of functional bloating. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION A total of 106 patients with functional bloating, between 20 and 50 years of age, participated in this double-blind randomized controlled trial. Patients were divided into 3 parallel groups that received 500 mg of placebo, dimethicone or KAASER, three times a day for 2 weeks. MAIN OUTCOME MEASURES The frequency and severity of bloating were primary outcomes, while the frequencies of eructation, defecation, borborygmus and early satiation were secondary outcomes. All parameters were evaluated at the beginning (week 0), and also weeks 2, 4 and 10 of the study, through self-report checklists with a scoring system. RESULTS Among the 84 patients who completed the study, the frequency and severity of bloating (P < 0.001), the frequencies of eructation, defecation and borborygmus (P = 0.03) were significantly improved in the group receiving KAASER (36 patients) compared with the dimethicone (35 patients) and placebo (35 patients) groups, during the 3 phases of follow-up. These significant differences persisted through the 2 and 8 weeks of follow-ups after cessation of medication (week 4 and 10). In early satiation, no significant differences were observed among the 3 groups. CONCLUSION The results showed that KAASER can be effectively used to treat patients suffering from bloating. Bloating, eructation, defecation and borborygmus in the KAASER group remained significantly improved after 2 and 8 weeks of cessation of medication, making this mechanism an interesting area for further investigation. TRIAL REGISTRATION Registration trial IRCT2015100324327N on Iranian Registry of Clinical Trials.",2019,"Bloating, eructation, defecation and borborygmus in the KAASER group remained significantly improved after 2 and 8 weeks of cessation of medication, making this mechanism an interesting area for further investigation. ","['106 patients with functional bloating, between 20 and 50\u202fyears of age']","['placebo', '500\u202fmg of placebo, dimethicone or KAASER', 'dimethicone', 'KAASER', 'Persian herbal formulation']","['frequency and severity of bloating', 'Bloating, eructation, defecation and borborygmus', 'frequencies of eructation, defecation and borborygmus', 'functional bloating', 'frequencies of eructation, defecation, borborygmus and early satiation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4302240', 'cui_str': 'Functional bloating (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1113707', 'cui_str': 'dimeticone'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0014724', 'cui_str': 'Belching'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0232693', 'cui_str': 'Borborygmi (finding)'}, {'cui': 'C4302240', 'cui_str': 'Functional bloating (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}]",106.0,0.15238,"Bloating, eructation, defecation and borborygmus in the KAASER group remained significantly improved after 2 and 8 weeks of cessation of medication, making this mechanism an interesting area for further investigation. ","[{'ForeName': 'Zienab', 'Initials': 'Z', 'LastName': 'Mahmoudpour', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol 47745-47176, Iran; Department of Persian Medicine, School of Persian Medicine, Babol University of Medical Sciences, Babol 47745-47176, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical Sciences, Babol 47745-47176, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran 19968-35113, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Meftah', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical Sciences, Babol 47745-47176, Iran.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Khafri', 'Affiliation': 'Biostatistics and Epidemiology Department, Medicine Faculty, Babol University of Medical Sciences, Babol 47745-47176, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Mozaffarpur', 'Affiliation': 'Traditional Medicine and History of Medical Sciences Research Center, Health Research Institute, Babol University of Medical Sciences, Babol 47745-47176, Iran. Electronic address: seyyedali1357@gmail.com.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shirafkan', 'Affiliation': 'Department of Biostatistics, Faculty of Health, Mazandaran University of Medical Sciences, Sari 48471-16548, Iran.'}]",Journal of integrative medicine,['10.1016/j.joim.2019.05.007'] 3521,31730042,Mediators of Intervention Effects on Depressive Symptoms Among People Living With HIV: Secondary Analysis of a Mobile Health Randomized Controlled Trial Using Latent Growth Curve Modeling.,"BACKGROUND Although several studies have investigated the effects of mobile health (mHealth) interventions on depression among people living with HIV, few studies have explored mediators of mHealth-based interventions to improve mental health in people living with HIV. Identifying influential mediators may enhance and refine effective components of mHealth interventions to improve mental health of people living with HIV. OBJECTIVE This study aimed to examine mediating factors of the effects of a mHealth intervention, Run4Love, designed to reduce depression among people living with HIV using 4 time-point measurement data. METHODS This study used data from a randomized controlled trial of a mHealth intervention among people living with HIV with elevated depressive symptoms in Guangzhou, China. A total of 300 patients were assigned to receive either the mHealth intervention (n=150) or a waitlist control group (n=150) through computer-generated block randomization. Depressive symptoms, coping, and HIV-related stigma were measured at baseline, 3-, 6-, and 9-month follow-ups. The latent growth curve model was used to examine the effects of the intervention on depressive symptoms via potential mediators. Mediating effects were estimated using bias-corrected 95% bootstrapped CIs (BCIs) with resampling of 5000. RESULTS Enhanced positive coping and reduced HIV-related stigma served as effective treatment mediators in the mHealth intervention. Specially, there was a significant indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of positive coping (beta=-2.86; 95% BCI -4.78 to -0.94). The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40). These findings indicated that enhancement of positive coping and reduction of HIV-related stigma were important mediating factors of the mHealth intervention in reducing depression among people living with HIV. CONCLUSIONS This study revealed the underlying mediators of a mHealth intervention to reduce depression among people living with HIV using latent growth curve model and 4 time-point longitudinal measurement data. The study results underscored the importance of improving positive coping skills and mitigating HIV-related stigma in mHealth interventions to reduce depression among people living with HIV.",2019,The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40).,"['people living with HIV', 'people living with HIV using 4 time-point measurement data', 'people living with HIV with elevated depressive symptoms in Guangzhou, China', '300 patients', 'People Living With HIV', 'people living with HIV using latent growth curve model and 4 time-point longitudinal measurement data']","['mHealth intervention (n=150) or a waitlist control group (n=150) through computer-generated block randomization', 'mobile health (mHealth) interventions', 'mHealth intervention']","['positive coping and reduced HIV-related stigma', 'slope of depressive symptoms', 'slope of depressive symptoms via the slope of HIV-related stigma', 'Depressive symptoms, coping, and HIV-related stigma', 'Depressive Symptoms', 'depressive symptoms via potential mediators']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",300.0,0.140585,The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40).,"[{'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Monroe-Wise', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center of Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, China Center for Disease Control, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}]",JMIR mHealth and uHealth,['10.2196/15489'] 3522,30950894,Comparison of Small Incision Lenticule Extraction Surgery With and Without Cyclotorsion Error Correction for Patients With Astigmatism.,"PURPOSE To evaluate the add-on effect of manual cyclotorsion error correction by the cornea-marking method over standard small incision lenticule extraction (SMILE) surgery in astigmatic eyes. METHODS Consecutive patients (84) who had preoperative myopic astigmatism of -0.75 diopters (D) or more and were seeking surgical refractive correction by SMILE surgery during July 2017 to August 2017 were included in this study and randomized to treatment with standard SMILE surgery (S group: 30 eyes) or cyclotorsion compensated SMILE surgery (CC group: 54 eyes). The visual acuity and refractive outcomes were analyzed preoperatively and postoperatively. Refractive astigmatic changes were analyzed by the Alpins method. RESULTS The S and CC groups were comparable preoperatively regarding age, manifest spherical equivalent, and manifest refractive cylinder. The mean position-related cyclotorsion degree in the enrolled astigmatic eyes for the S and CC groups was 1.7 ± 2.2 degrees (ranging from 0 to 10 degrees) and 2.19 ± 1.74 degrees (ranging from 0 to 10 degrees), respectively. The mean cylinder was -1.67 ± 0.54 D versus -1.72 ± 0.71 D preoperatively. Six months after treatment, the surgical outcomes in the CC group were significantly better than those of the S group, with a postoperative corrected distance visual acuity of -0.07 ± 0.07 versus 0.016 ± 0.13. A vector analysis of astigmatism also yielded better outcomes in the CC group. However, these 2 groups were statistically similar in spherical equivalent. CONCLUSIONS SMILE surgery combined with cyclotorsion error compensation yielded a significant improvement in surgical outcomes regarding safety, efficiency, and predictability for patients with astigmatism.",2019,The mean cylinder was -1.67 ± 0.54 D versus -1.72 ± 0.71 D preoperatively.,"['Consecutive patients (84) who had preoperative myopic astigmatism of -0.75 diopters (D) or more and were seeking surgical refractive correction by SMILE surgery during July 2017 to August 2017', 'patients with astigmatism', 'Patients With Astigmatism']","['standard SMILE surgery (S group: 30 eyes) or cyclotorsion compensated SMILE surgery', 'manual cyclotorsion error correction by the cornea-marking method over standard small incision lenticule extraction (SMILE) surgery', 'Small Incision Lenticule Extraction Surgery']","['postoperative corrected distance visual acuity', 'visual acuity and refractive outcomes', 'Refractive astigmatic changes', 'surgical outcomes', 'mean position-related cyclotorsion degree', 'surgical outcomes regarding safety, efficiency, and predictability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0537442,The mean cylinder was -1.67 ± 0.54 D versus -1.72 ± 0.71 D preoperatively.,"[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jiexu', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhuang', 'Affiliation': ''}, {'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ''}]",Cornea,['10.1097/ICO.0000000000001937'] 3523,31173422,"Effectiveness of a large-scale handwashing promotion intervention on handwashing behaviour in Dhaka, Bangladesh.","OBJECTIVE The behavioural effect of large-scale handwashing promotion programmes has been infrequently evaluated, and variation in the effect over time has not been described. We assess the effect of a large-scale handwashing promotion programme on handwashing outcomes in a community setting in Dhaka, Bangladesh. METHODS We analysed data from a cluster-randomised trial that included three arms: vaccine-and-behaviour-change intervention (VBC), vaccine-only (V) and no intervention (Control). Data collectors randomly selected different subsets of households each month during the study period and assessed: (i) temporal variation in availability of soap and water at handwashing place; (ii) the use of water and soap by participants when asked to demonstrate handwashing, and; (iii) handwashing behaviour according to structured observation. We used log-binomial regression analyses to calculate prevalence ratios (PRs) and 95% confidence intervals and compare outcomes by study arms. RESULTS Data collectors surveyed 9325 households over 28 months. In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297). In the entire study period, availability of water and soap was higher in VBC (43%) than in V (23%) (PR = 1.92; CI = 1.72, 2.15) and Control (28%) (PR = 1.53; CI = 1.38, 1.69) households. There were no differences between study arms with regard to use of soap during handwashing demonstrations. Observed handwashing with soap after toilet use was higher in VBC (17%) than in V (8%) (PR = 1.47, CI = 0.58, 3.75) and Control (2%) (PR = 3.47, CI = 0.48, 23.33) groups. At other possible pathogen transmission events, the prevalence of handwashing with soap was ≤3%. CONCLUSION VBC households maintained soap and water for handwashing, but the prevalence of observed handwashing was low in all study arms. The results underscore the need to strengthen scalable behaviour change approaches.",2019,"In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297).","['Data collectors randomly selected different subsets of households each month during the study period and assessed: (i) temporal variation in availability of soap and water at handwashing place; (ii) the use of water and soap by participants when asked to demonstrate handwashing, and; (iii) handwashing behaviour according to structured observation', 'a community setting in Dhaka, Bangladesh', 'Data collectors surveyed 9325 households over 28\xa0months', 'handwashing behaviour in Dhaka, Bangladesh']","['large-scale handwashing promotion intervention', 'large-scale handwashing promotion programme', 'vaccine-and-behaviour-change intervention (VBC), vaccine-only (V) and no intervention (Control']","['availability of water and soap', 'prevalence of handwashing with soap']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}]",9325.0,0.0525134,"In VBC, there was a significant positive trend on availability of water and soap from baseline to 9 months after the start of the intervention (P-for-trends <0.001), and no significant trend during months 10-28 (P-for-trend = 0.297).","[{'ForeName': 'Wit', 'Initials': 'W', 'LastName': 'Wichaidit', 'Affiliation': 'Department of Epidemiology and Environmental Health, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Shwapon', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Begum', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Yeasmin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Fosiul Alam', 'Initials': 'FA', 'LastName': 'Nizame', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Najnin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Leontsini', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'Department of Epidemiology and Environmental Health, State University of New York, Buffalo, NY, USA.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13277'] 3524,29288881,A Novel Screening Method to Identify Late-Stage Dementia Patients for Palliative Care Research and Practice.,"CONTEXT Investigators need novel methods for timely identification of patients with serious illness to test or implement new palliative care models. OBJECTIVES The study's aim was to develop an electronic health record (EHR) phenotype to identify patients with late-stage dementia for a clinical trial of palliative care consultation. METHODS We developed a computerized method to identify patients with dementia on hospital admission. Within a data warehouse derived from the hospital's EHR, we used search terms of age, admission date, and ICD-9 and ICD-10 diagnosis codes to create an EHR dementia phenotype, followed by brief medical record review to confirm late-stage dementia. We calculated positive predictive value, false discovery rate, and false negative rate of this novel screening method. RESULTS The EHR phenotype screening method had a positive predictive value of 76.3% for dementia patients and 24.5% for late-stage dementia patients; a false discovery rate of 23.7% for dementia patients and 75.5% for late-stage dementia patients compared to physician assessment. The sensitivity of this screening method was 59.7% to identify hospitalized patients with dementia. Daily screening-including confirmatory chart reviews-averaged 20 minutes and was more feasible, efficient, and more complete than manual screening. CONCLUSION A novel method using an EHR phenotype plus brief medical record review is effective to identify hospitalized patients with late-stage dementia. In health care systems with similar clinical data warehouses, this method may be applied to serious illness populations to improve enrollment in clinical trials of palliative care or to facilitate access to palliative care services.",2018,"Daily screening-including confirmatory chart reviews-averaged 20 minutes and was more feasible, efficient, and more complete than manual screening. ","['hospitalized patients with dementia', 'hospitalized patients with late-stage dementia', 'patients with late-stage dementia for a clinical trial of palliative care consultation', 'patients with dementia on hospital admission']",[],['false discovery rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",[],"[{'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",,0.0648386,"Daily screening-including confirmatory chart reviews-averaged 20 minutes and was more feasible, efficient, and more complete than manual screening. ","[{'ForeName': 'Natalie C', 'Initials': 'NC', 'LastName': 'Ernecoff', 'Affiliation': 'Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA. Electronic address: ernecoff@live.unc.edu.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Wessell', 'Affiliation': 'Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Gabriel', 'Affiliation': 'Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Carey', 'Affiliation': 'Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA; Departments of Medicine and Social Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Hanson', 'Affiliation': 'Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA; Division of Geriatric Medicine & Palliative Care Program, University of North Carolina, Chapel Hill, North Carolina, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2017.12.480'] 3525,31240312,Discovery and Validation of Banana Intake Biomarkers Using Untargeted Metabolomics in Human Intervention and Cross-sectional Studies.,"BACKGROUND Banana is one of the most widely consumed fruits in the world. However, information regarding its health effects is scarce. Biomarkers of banana intake would allow a more accurate assessment of its consumption in nutrition studies. OBJECTIVES Using an untargeted metabolomics approach, we aimed to identify the banana-derived metabolites present in urine after consumption, including new candidate biomarkers of banana intake. METHODS A randomized controlled study with a crossover design was performed on 12 healthy subjects (6 men, 6 women, mean ± SD age: 30.0 ± 4.9 y; mean ± SD BMI: 22.5 ± 2.3 kg/m2). Subjects underwent 2 dietary interventions: 1) 250 mL control drink (Fresubin 2 kcal fiber, neutral flavor; Fresenius Kabi), and 2) 240 g banana + 150 mL control drink. Twenty-four-hour urine samples were collected and analyzed with ultra-performance liquid chromatography coupled to a quadrupole time-of-flight MS and 2-dimensional GC-MS. The discovered biomarkers were confirmed in a cross-sectional study [KarMeN (Karlsruhe Metabolomics and Nutrition study)] in which 78 subjects (mean BMI: 22.8; mean age: 47 y) were selected reflecting high intake (126-378 g/d), low intake (47.3-94.5 g/d), and nonconsumption of banana. The confirmed biomarkers were examined singly or in combinations, for established criteria of validation for biomarkers of food intake. RESULTS We identified 33 potentially bioactive banana metabolites, of which 5 metabolites, methoxyeugenol glucuronide (MEUG-GLUC), dopamine sulfate (DOP-S), salsolinol sulfate, xanthurenic acid, and 6-hydroxy-1-methyl-1,2,3,4-tetrahydro-β-carboline sulfate, were confirmed as candidate intake biomarkers. We demonstrated that the combination of MEUG-GLUC and DOP-S performed best in predicting banana intake in high (AUCtest = 0.92) and low (AUCtest = 0.87) consumers. The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. CONCLUSIONS Our metabolomics study in healthy men and women revealed new putative bioactive metabolites of banana and a combined biomarker of intake. These findings will help to better decipher the health effects of banana in future focused studies. This study was registered at clinicaltrials.gov as NCT03581955 and with the Ethical Committee for the Protection of Human Subjects Sud-Est 6 as CPP AU 1251, IDRCB 2016-A0013-48; the KarMeN study was registered with the German Clinical Trials Register (DRKS00004890). Details about the study can be obtained from https://www.drks.de.",2019,"The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. ","['47 y) were selected reflecting high intake (126-378 g/d), low intake (47.3-94.5 g/d), and nonconsumption of banana', 'mean age', 'healthy men and women', 'Human Subjects Sud-Est 6 as CPP AU 1251, IDRCB 2016-A0013-48', '12 healthy subjects (6 men, 6 women, mean\xa0±', 'SD age: 30.0\xa0±\xa04.9 y', '78 subjects (mean BMI: 22.8']","['2 dietary interventions: 1) 250 mL control drink (Fresubin 2 kcal fiber, neutral flavor; Fresenius Kabi), and 2) 240', '5 metabolites, methoxyeugenol glucuronide (MEUG-GLUC), dopamine sulfate (DOP-S), salsolinol sulfate, xanthurenic acid, and 6-hydroxy-1-methyl-1,2,3,4-tetrahydro-β-carboline sulfate', 'g banana\xa0+\xa0150 mL control drink']",['mean\xa0±'],"[{'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0600510', 'cui_str': 'ESTs'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0208329', 'cui_str': 'Fresubin'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0074002', 'cui_str': 'Salsolinol'}, {'cui': 'C0078610', 'cui_str': '8-hydroxykynurenic acid'}, {'cui': 'C2584674', 'cui_str': 'Carboline (substance)'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",12.0,0.0286401,"The new biomarkers met key criteria establishing their current applicability in nutrition and health research for assessing the occurrence of banana intake. ","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Vázquez-Manjarrez', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige, Italy.""}, {'ForeName': 'Carina I', 'Initials': 'CI', 'LastName': 'Mack', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Micheau', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Pétéra', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Durand', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Pujos-Guillot', 'Affiliation': ""Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Egert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige, Italy.""}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Bub', 'Affiliation': 'Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabine E', 'Initials': 'SE', 'LastName': 'Kulling', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Manach', 'Affiliation': 'Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France.'}]",The Journal of nutrition,['10.1093/jn/nxz125'] 3526,30928442,Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial.,"OBJECTIVES The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial. BACKGROUND There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV. METHODS Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach. RESULTS A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths. CONCLUSIONS Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).",2019,"Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54).","['171 patients were randomized at 4 centers', 'Consecutive patients with severe aortic stenosis']","['TAVR', 'transcatheter aortic valve replacement with pre-dilatation', 'Pre-Dilatation Versus No Pre-Dilatation', 'self-expanding valve with or without balloon aortic valvuloplasty (BAV', 'transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation', 'BAV']","['periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality', 'periprocedural stroke', 'Device success', 'Lower post-dilatation rates', 'device success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0396949', 'cui_str': 'Valvuloplasty of aortic valve (procedure)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",171.0,0.107858,"Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54).","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Toutouzas', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece. Electronic address: ktoutouz@gmail.com.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Benetos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Vasilis', 'Initials': 'V', 'LastName': 'Voudris', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Drakopoulou', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stathogiannis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Latsios', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Synetos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Antonopoulos', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kosmas', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Iakovou', 'Affiliation': 'Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Katsimagklis', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Mastrokostopoulos', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Sotiris', 'Initials': 'S', 'LastName': 'Moraitis', 'Affiliation': 'Naval Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Zeniou', 'Affiliation': 'Heart Institute, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Haim', 'Initials': 'H', 'LastName': 'Danenberg', 'Affiliation': 'Heart Institute, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Manolis', 'Initials': 'M', 'LastName': 'Vavuranakis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'First Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, Greece.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.02.005'] 3527,31760820,Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi.,"BACKGROUND Circumferential pulmonary vein isolation (CPVI) often cause unavoidable vagal reflexes during procedure due to the coincidental modification of ganglionated plexus which are located on pulmonary vein (PV) antrum. The right anterior ganglionated plexi (RAGP) which located at superoanterior area of right superior PV antrum is an essential station to regulate the cardiac autonomic nerve activities and is easily coincidentally ablated during CPVI. The aim of this study is to assess the effect of RAGP ablation on vagal response (VR) during CPVI. METHODS A total of 80 patients with paroxysmal atrial fibrillation who underwent the first time CPVI were prospectively enrolled and randomly assigned to 2 groups: group A (n=40), CPVI started with right PVs at RAGP site; group B (n=40): CPVI started with left PVs first, and the last ablation site is RAGP. Electrophysiological parameters include basal cycle length, A-H interval, H-V interval, sinus node recovery time, and atrioventricular node Wenckebach point were recorded before and after CPVI procedure. RESULTS During CPVI, the positive VR were only observed on 1 patient in group A and 25 patients in group B ( P <0.001). A total of 21 patients with positive VR in group B needed for temporary ventricular pacing during procedure, while the only patient with positive VR in group A did not need for temporary ventricular pacing ( P <0.001). Compared with baseline, basal cycle length, sinus node recovery time, and atrioventricular node Wenckebach point were decreased significantly after CPVI procedure in both groups (all P <0.05) and without differences between 2 groups. CONCLUSIONS Circumferential PV isolation initiated from RAGP could effectively inhibit VR occurrence and significantly increase heart rate during procedure.",2019,A did not need for temporary ventricular pacing ( P <0.001).,"['21 patients with', '80 patients with paroxysmal atrial fibrillation who underwent the first time CPVI']","['temporary ventricular pacing', 'Circumferential pulmonary vein isolation (CPVI', 'positive VR', 'RAGP ablation', 'CPVI started with right PVs at RAGP site']","['basal cycle length, A-H interval, H-V interval, sinus node recovery time, and atrioventricular node Wenckebach point', 'vagal response (VR', 'basal cycle length, sinus node recovery time, and atrioventricular node Wenckebach point', 'positive VR', 'temporary ventricular pacing', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037189', 'cui_str': 'Sinuatrial Node'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004247', 'cui_str': 'AV Node'}, {'cui': 'C0264907', 'cui_str': 'Mobitz type I incomplete atrioventricular block (disorder)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",80.0,0.0225212,A did not need for temporary ventricular pacing ( P <0.001).,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shangyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lishui', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Erpeng', 'Initials': 'E', 'LastName': 'Liang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.007811'] 3528,31801388,Anti-inflammatory Medication of Cataract Surgery in Pseudoexfoliation Syndrome - NSAID Is Needed.,"BACKGROUND To optimize the anti-inflammatory treatment of cataract surgery in pseudoexfoliation syndrome (PXF) eyes. METHODS A prospective randomized double-masked trial. Sixty eyes of 60 patients with PXF undergoing routine cataract surgery were randomized for potent topical postoperative anti-inflammatory medication either with prednisolone acetate (10mg/ml), nepafenac (1mg/ml) or their combination. Clinical outcome parameters were recorded at 28 days and 3 months. Recovery from surgery was recorded by a structured home questionnaire. RESULTS Patient age and gender distribution, and all baseline ophthalmic and surgical parameters were comparable between the study groups. At 28 days, change in central subfield macular thickness was +11.4 ± 11.9 µm in prednisolone acetate group compared to +1.7 ± 16.8 µm in nepafenac ( P = .017), and -0.3 ± 8.7 µm in combination therapy ( P = .010) groups. At 3 months, the values were +11.8 ± 18.1 µm, +1.8 ± 17.5 µm ( P = .055), and -1.3 ± 6.4 µm ( P = .055), respectively. Pseudophakic cystoid macular edema (PCME) was reported in two eyes, both with prednisolone acetate monotherapy. After surgery, conjunctival injection lasted 6.5 ± 5.0 days and irritation of the eye 9.5 ± 8.5 days in prednisolone acetate group compared with nepafenac (2.6 ± 2.2 days; P = .037 and 4.3 ± 5.2 days; P = NS, respectively) and combination therapy (3.3 ± 1.9 days; P = NS and 3.0 ± 4.0 days; P = .025, respectively). CONCLUSIONS Routine cataract surgery of PXF eyes with nonsteroidal anti-inflammatory drugs (NSAID) alone, or in combination with steroids resulted in faster recovery from surgery and avoidance of PCME compared to steroids alone. ABBREVIATIONS BAB: blood-aqueous barrier; CDVA: corrected distance visual acuity; CDE: cumulative dissipated energy; CSMT: central subfield macular thickness; HRQoL: Health-related quality of life; IOP: intraocular pressure; logMAR: log of the minimum angle of resolution; NSAID: nonsteroidal anti-inflammatory drug; PCME: pseudophakic cystoid macular edema; PXF: pseudoexfoliation syndrome; OCT: optical coherence tomography; t.i.d.: three times a day; VA: visual acuity.",2020,"At 28 days, change in central subfield macular thickness was +11.4±11.9µm in prednisolone acetate group compared to +1.7±16.8µm in nepafenac ( P =0.017), and -0.3±8.7µm in combination therapy ( P =0.010) groups.","['pseudoexfoliation syndrome - NSAID', 'pseudoexfoliation syndrome (PXF) eyes', 'Sixty eyes of 60 patients with PXF undergoing routine cataract surgery']","['nepafenac', 'prednisolone acetate monotherapy', 'cataract surgery', 'nonsteroidal anti-inflammatory drugs (NSAID) alone, or in combination with steroids', 'prednisolone acetate', 'topical postoperative anti-inflammatory medication either with prednisolone acetate (10mg/ml), nepafenac (1mg/ml) or their combination']","['Pseudophakic cystoid macular edema (PCME', 'central subfield macular thickness']","[{'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0645984', 'cui_str': 'PCME'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",60.0,0.145893,"At 28 days, change in central subfield macular thickness was +11.4±11.9µm in prednisolone acetate group compared to +1.7±16.8µm in nepafenac ( P =0.017), and -0.3±8.7µm in combination therapy ( P =0.010) groups.","[{'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Ilveskoski', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Taipale', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}]",Current eye research,['10.1080/02713683.2019.1701686'] 3529,31230938,Design of CTP-PRO study (impact of stress Cardiac computed Tomography myocardial Perfusion on downstream resources and PROgnosis in patients with suspected or known coronary artery disease: A multicenter international study).,"BACKGROUND CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined. The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups. METHODS CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy (Group A) versus usual care (Group B) in intermediate-high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation. A total sample size of 2000 subjects will be enrolled and followed up for 24 months. The primary endpoint is the reclassification rate of CCTA in group A due to the addition of CTP. The secondary endpoint will be the comparison between groups in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years. CONCLUSIONS The study will provide information to patients, health care providers and other stakeholders about which strategy could be more effective in the diagnosis of suspected CAD in intermediate to high-risk patients or in the symptomatic patients with known CAD and previous history of revascularization.",2019,"The secondary endpoint will be the comparison between groups in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years.","['intermediate-high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation', 'patients with suspected or known coronary artery disease', '2000 subjects will be enrolled and followed up for 24\u202fmonths']","['stress Cardiac computed Tomography myocardial Perfusion', 'CCTA+CTP strategy (Group A) versus usual care', 'CT myocardial perfusion imaging (CTP']","['non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years', 'reclassification rate of CCTA', 'MACE and cost-effectiveness']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2000.0,0.047429,"The secondary endpoint will be the comparison between groups in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy. Electronic address: gianluca.pontone@ccfm.it.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'De Cecco', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Andrea I', 'Initials': 'AI', 'LastName': 'Guaricci', 'Affiliation': 'Institute of Cardiovascular Disease, Department of Emergency and Organ Transplantation, University Hospital Policlinico, Bari, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Leiner', 'Affiliation': 'Department of Radiology, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Lima', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, USA.'}, {'ForeName': 'Pál', 'Initials': 'P', 'LastName': 'Maurovich-Horvat', 'Affiliation': 'MTA-SE Cardiovascular Imaging Research Group (CIRG) Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Muscogiuri', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Nance', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.06.012'] 3530,31871257,"Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study.","BACKGROUND Low back pain is a very prevalent condition in the population and cupping therapy has been presented as a frequently used non-pharmacological treatment in this population. However, there is a lack of well-designed studies that evaluate the effects of this technique. This protocol describes a placebo-controlled, randomised, double-blind study that aims to evaluate the effect of dry cupping therapy on pain, physical function, trunk range of motion, quality of life and psychological symptoms in individuals with non-specific chronic low back pain. METHODS AND ANALYSIS Ninety individuals with chronic non-specific low back pain, aged from 18 to 59 years, will be randomised into two groups: intervention group, which will be submitted to dry cupping therapy application with two suctions; and placebo group which will undergo placebo dry cupping therapy. Both applications will occur bilaterally in parallel to the vertebrae from L1 to L5. The application will be performed once a week for 8 weeks. The volunteers will be evaluated before the treatment (T0), immediately after the first intervention (T1), after 4 weeks of intervention (T4) and after 8 weeks of intervention (T8). The primary outcome will be pain intensity, and secondary outcomes will be physical function, lumbar range of motion, patient expectation, overall perception of effect, quality of life and psychological factors. ETHICS AND DISSEMINATION This protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 3639814). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings. TRIAL REGISTRATION NUMBER NCT03909672.",2019,"The volunteers will be evaluated before the treatment (T0), immediately after the first intervention (T1), after 4 weeks of intervention (T4) and after 8 weeks of intervention (T8).","['individuals with non-specific chronic low back pain', 'Ninety individuals with chronic non-specific low back pain, aged from 18 to 59 years']","['placebo', 'Dry cupping', 'placebo dry cupping therapy', 'dry cupping therapy']","['pain intensity, and secondary outcomes will be physical function, lumbar range of motion, patient expectation, overall perception of effect, quality of life and psychological factors', 'pain, physical function, trunk range of motion, quality of life and psychological symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0394663', 'cui_str': 'Cupping (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",90.0,0.328122,"The volunteers will be evaluated before the treatment (T0), immediately after the first intervention (T1), after 4 weeks of intervention (T4) and after 8 weeks of intervention (T8).","[{'ForeName': 'Hugo Jário de Almeida', 'Initials': 'HJA', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Universidade Federal do Rio Grande do Norte, Faculdade de Ciências da Saúde do Trairi, Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Saragiotto', 'Affiliation': ""Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil.""}, {'ForeName': 'Rodrigo Scattone', 'Initials': 'RS', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Universidade Federal do Rio Grande do Norte, Faculdade de Ciências da Saúde do Trairi, Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Caio Alano de Almeida', 'Initials': 'CAA', 'LastName': 'Lins', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Universidade Federal do Rio Grande do Norte, Faculdade de Ciências da Saúde do Trairi, Santa Cruz, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Marcelo Cardoso', 'Initials': 'MC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Universidade Federal do Rio Grande do Norte, Faculdade de Ciências da Saúde do Trairi, Santa Cruz, Rio Grande do Norte, Brazil marcelocardoso@facisa.ufrn.br.'}]",BMJ open,['10.1136/bmjopen-2019-032416'] 3531,31291447,Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity.,"BACKGROUND Different fatty acids (FAs) can vary in their obesogenic effect, and genetic makeup can contribute to fat deposition in response to dietary FA composition. However, the antiobesogenic effects of the interactions between dietary MUFAs and genetics have scarcely been tested in intervention studies. OBJECTIVE We evaluated the overall (primary outcome) and genetically modulated (secondary outcome) response in body weight and fat mass to different levels of MUFA consumption. METHODS In the Canola Oil Multicenter Intervention Trial II, a randomized, crossover, isocaloric, controlled-feeding multicenter trial, 44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm) consumed each of 3 oils for 6 wk, separated by four 12-wk washout periods. Oils included 2 high-MUFA oils-conventional canola and high-oleic canola (<7% SFAs, >65% MUFAs)-and 1 low-MUFA/high-SFA oil blend (40.2% SFAs, 22.0% MUFAs). Body fat was measured using DXA. Five candidate single-nucleotide polymorphisms (SNPs) were genotyped using qualitative PCR. Data were analyzed using a repeated measures mixed model. RESULTS No significant differences were observed in adiposity measures following the consumption of either high-MUFA diet compared with the low-MUFA/high-SFA treatment. However, when stratified by genotype, 3 SNPs within lipoprotein lipase (LPL), adiponectin, and apoE genes influenced, separately, fat mass changes in response to treatment (n = 101). Mainly, the LPL rs13702-CC genotype was associated with lower visceral fat (high-MUFA: -216.2 ± 58.6 g; low-MUFA: 17.2 ± 81.1 g; P = 0.017) and android fat mass (high-MUFA: -267.3 ± 76.4 g; low-MUFA: -21.7 ± 102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. CONCLUSIONS Common variants in LPL, adiponectin, and apoE genes modulated body fat mass response to dietary MUFAs in an isocaloric diet in adults with abdominal obesity. These findings might eventually help in developing personalized dietary recommendations for weight control. The trial was registered at clinicaltrials.gov as NCT02029833 (https://www.clinicaltrials.gov/ct2/show/NCT02029833?cond=NCT02029833&rank=1).",2019,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. ","['adults with abdominal obesity', 'Adults with Abdominal Obesity', '44 men and 71 women with a mean age of 44 y and an increased waist circumference (men ∼108 cm and women ∼102 cm']","['MUFA oils-conventional canola and high-oleic canola', 'Dietary Monounsaturated Fatty Acids']","['adiposity measures', 'Body fat', 'body weight and fat mass to different levels of MUFA consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",44.0,0.0925839,"102.2 g; P = 0.037) following average consumption of the 2 high-MUFA diets. ","[{'ForeName': 'Shatha S', 'Initials': 'SS', 'LastName': 'Hammad', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eck', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sihag', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Connelly', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Lamarche', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Couture', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Guay', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Maltais-Giguère', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, Quebec, Quebec, Canada.'}, {'ForeName': 'Sheila G', 'Initials': 'SG', 'LastName': 'West', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'David J A', 'Initials': 'DJA', 'LastName': 'Jenkins', 'Affiliation': ""Keenan Research Centre for Biomedical Science of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Castillo', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter J H', 'Initials': 'PJH', 'LastName': 'Jones', 'Affiliation': 'Department of Food and Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxz136'] 3532,31755872,Mood Monitoring Over One Year for People With Chronic Obstructive Pulmonary Disease Using a Mobile Health System: Retrospective Analysis of a Randomized Controlled Trial.,"BACKGROUND Comorbid anxiety and depression can add to the complexity of managing treatment for people living with chronic obstructive pulmonary disease (COPD). Monitoring mood has the potential to identify individuals who might benefit from additional support and treatment. OBJECTIVE We used data from the sElf-management anD support proGrammE (EDGE) trial to examine: (1) the extent to which the mood-monitoring components of a mobile health system for patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring. METHODS A total of 107 men and women with a clinical diagnosis of COPD, aged ≥40 years old, were recruited to the intervention arm of the EDGE trial. Participants were invited to complete the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 test every four weeks using a tablet computer. Mood disturbance based on these measures was defined as a score ≥5 on either scale. Participants reporting a mood disturbance were automatically directed (signposted) to a stress or mood management video. Study outcomes included measures of health status, respiratory quality of life, and symptoms of anxiety and depression. RESULTS Overall, 94 (87.9%) participants completed the 12-month study. A total of 80 participants entered at least one response each month for at least ten months. On average, 16 participants (range 8-38 participants) entered ≥2 responses each month. Of all the participants, 47 (50%) gave responses indicating a mood disturbance. Participants with a mood disturbance score for both scales (n=47) compared with those without (n=20) had lower health status (P=.008), lower quality of life (P=.009), and greater anxiety (P<.001) and increased depression symptoms (P<.001). Videos were viewed by 64 (68%) people over 12 months. Of the 220 viewing visualizations, 70 (34.7%) began after being signposted. Participants signposted to the stress management video (100%; IQR 23.3-100%) watched a greater proportion of it compared to those not signposted (38.4%; IQR 16.0-68.1%; P=.03), whereas duration of viewing was not significantly different for the mood management video. CONCLUSIONS Monitoring of anxiety and depression symptoms for people with COPD is feasible. More than half of trial participants reported scores indicating a mood disturbance during the study. Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video. The opportunity to elicit measures of mood regularly as part of a health monitoring system could contribute to better care for people with COPD.",2019,Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video.,"['107 men and women with a clinical diagnosis of COPD, aged ≥40 years old', 'people living with chronic obstructive pulmonary disease (COPD', 'People With Chronic Obstructive Pulmonary Disease', 'people with COPD', '16 participants (range 8-38 participants) entered ≥2 responses each month', 'patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring', '80 participants entered at least one response each month for at least ten months']",[],"['Mood disturbance', 'mood disturbance score', 'stress management video', 'mood disturbance', 'lower quality of life', 'lower health status', 'duration of viewing', 'health status, respiratory quality of life, and symptoms of anxiety and depression', 'depression symptoms']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0424113', 'cui_str': 'Level of mood (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",38.0,0.135796,Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video.,"[{'ForeName': 'Maxine E', 'Initials': 'ME', 'LastName': 'Whelan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14946'] 3533,30293198,Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial.,"Vitamin D supplementation is often used in the prevention and treatment of osteoporosis, but the role of vitamin D has lately been questioned. We aimed to investigate the effect of 3 months of daily vitamin D3 supplementation (70 µg [2800 IU] vs. placebo) initiated in winter months on bone health. This study is a double-blinded placebo-controlled randomized trial. Bone health was assessed by bone turnover markers, DXA, HRpQCT, and QCT scans. The participants were 81 healthy postmenopausal women with low 25(OH)D (< 50 nmol/l) and high PTH levels (> 6.9 pmol/l) at screening. Vitamin D3 supplementation significantly increased levels of 25(OH)D and 1,25(OH) 2 D by 59 nmol/l and 19 pmol/l, respectively, whereas PTH was reduced by 0.7 pmol/l (all p < 0.0001). Compared with placebo, vitamin D3 did not affect bone turnover markers, aBMD by DXA or trabecular bone score. Vitamin D3 increased trabecular vBMD (QCT scans) in the trochanter region (0.4 vs. - 0.7 g/cm 3 ) and the femoral neck (2.1 vs. - 1.8 g/cm 3 ) p all  < 0.05. HRpQCT scans of the distal tibia showed reduced trabecular number (- 0.03 vs. 0.05 mm -1 ) and increased trabecular thickness (0.001 vs. - 0.005 mm), as well as an improved estimated bone strength as assessed by failure load (0.1 vs. - 0.1 kN), and stiffness (2.3 vs. - 3.1 kN/mm p all  ≤ 0.01). Changes in 25(OH)D correlated significantly with changes in trabecular thickness, stiffness, and failure load. Three months of vitamin D3 supplementation improved bone strength and trabecular thickness in tibia, vBMD in the trochanter and femoral neck, but did not affect aBMD.",2019,"Compared with placebo, vitamin D3 did not affect bone turnover markers, aBMD by DXA or trabecular bone score.",['81 healthy postmenopausal women with low 25(OH)D (<\u200950\xa0nmol/l) and high PTH levels (>\u20096.9\xa0pmol/l) at screening'],"['placebo', 'placebo, vitamin D3', 'Vitamin D3 Supplementation', 'Placebo', 'Vitamin D supplementation', 'daily vitamin D3 supplementation', 'vitamin D3 supplementation', 'Vitamin D3 supplementation', 'Vitamin D3']","['bone turnover markers, aBMD by DXA or trabecular bone score', 'femoral neck', 'trabecular thickness', 'trabecular vBMD (QCT scans', 'PTH', 'Bone health', 'bone strength and trabecular thickness in tibia, vBMD in the trochanter and femoral neck', 'estimated bone strength', 'trabecular thickness, stiffness, and failure load', 'levels of 25(OH)D and 1,25(OH', 'bone health', 'trabecular number', 'bone turnover markers, DXA, HRpQCT, and QCT scans']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study (procedure)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441633'}]",81.0,0.351205,"Compared with placebo, vitamin D3 did not affect bone turnover markers, aBMD by DXA or trabecular bone score.","[{'ForeName': 'Lise Sofie', 'Initials': 'LS', 'LastName': 'Bislev', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus, Denmark. lise.sofie@auh.rm.dk.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Langagergaard Rødbro', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rolighed', 'Affiliation': 'Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sikjaer', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rejnmark', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200, Aarhus, Denmark.'}]",Calcified tissue international,['10.1007/s00223-018-0481-6'] 3534,31863406,One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial.,"In patients with migraine, depression is associated with poorer medical prognosis, decreased quality of life, and increased risk of suicidality and disability; yet, behavioral interventions have rarely been investigated. The current study compared the efficacy of two 1-day (5- to 6-h) interventions for co-occurring migraine and depression: (1) acceptance and commitment therapy plus migraine education (ACT-ED), and (2) support plus migraine education (S-ED). One hundred and thirty-six patients with comorbid depression and migraine were randomized to a treatment. One hundred and three (76%) completed the ACT-ED (N = 56) or S-ED (N = 47) workshop. Primary outcomes were depression diagnosis and symptoms. Secondary outcomes were anxiety symptoms, headache-related disability and general functioning, and quality of life. Assessments were completed at baseline and 3 and 6 months following the workshop. At the 6-month follow-up, on categorical outcomes, a significantly greater number of people in the ACT-ED condition no longer met criteria for a major depressive episode and exhibited a > 50% drop in symptoms on the Hamilton Rating Scale of Depression. Similarly, though, weaker results were found when examining depressive symptoms dimensionally. On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning. A 1-day (5- to 6-h) ACT workshop can deliver substantial and lasting benefits to depressed migraineurs, over and above those provided by group support and education. This approach is an attractive alternative to weekly psychotherapy. Clinicaltrials.gov # NCT02108678.",2020,"On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning.","['Depressed Migraine Patients', 'One hundred and thirty-six patients with comorbid depression and migraine']","['two 1-day (5- to 6-h) interventions for co-occurring migraine and depression: (1) acceptance and commitment therapy plus migraine education (ACT-ED), and (2) support plus migraine education']","['anxiety, headache-related disability, and quality of social relationships', 'quality of life, and increased risk of suicidality and disability', 'depression diagnosis and symptoms', 'anxiety symptoms, headache-related disability and general functioning, and quality of life', 'general functioning', 'Hamilton Rating Scale of Depression']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",136.0,0.0886674,"On secondary outcomes, people in the ACT-ED condition exhibited significantly greater improvements in anxiety, headache-related disability, and quality of social relationships, compared to S-ED, No differences between groups were observed in general functioning.","[{'ForeName': 'Lilian N', 'Initials': 'LN', 'LastName': 'Dindo', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Holcombe, Houston, TX, 77030, USA. lilian.dindo@bcm.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Recober', 'Affiliation': ""University of Pennsylvania & the Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Chadi A', 'Initials': 'CA', 'LastName': 'Calarge', 'Affiliation': 'Department of Internal Medicine, Section of Health Services Research, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Weinrib', 'Affiliation': 'Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Turvey', 'Affiliation': 'Department of Psychiatry, University of Iowa, Iowa City, IA, USA.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-019-00818-0'] 3535,31923472,Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial.,"Despite the burdens costs can place on adults with diabetes, few evidence-based, scalable interventions have been identified that address prevalent health-related financial burdens and unmet social risk factors that serve as major obstacles to effective diabetes management. In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care. We will determine the effectiveness of CareAvenue relative to standard care with respect to improving glycemic control and patient-centered outcomes such as cost-related non-adherence (CRN) behaviors and perceived financial burden. We will also examine the role of patient risk factors (moderators) and behavioral factors (mediators) on the effectiveness of CareAvenue in improving outcomes. We will recruit 720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden. Participants will be randomized to one of two arms: 1) receipt of a 15-20 min web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services. Outcomes will be assessed at baseline and 6- and 12-month follow-up. Clinical Trial Registration: ClinicalTrials.gov ID NCT03950973, May 2019.",2020,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","['720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden', 'adults with diabetes']",['receipt of a 15-20\u202fmin web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services'],['unmet social risk factors and diabetes outcomes'],"[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",720.0,0.0729143,"In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care.","[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105933'] 3536,31943189,A pilot investigation of universal school-based prevention programs for anxiety and depression symptomology in children: A randomized controlled trial.,"OBJECTIVE The current study aimed to provide a preliminary evaluation of two universal school-based prevention programs, Emotion Regulation (ER) and Behavioral Activation (BA), by increasing resilience to manage excessive worry, a transdiagnostic feature across anxiety and depression. METHOD Primary school children (N = 295; 52.5% female; 8-13 years) from five Australian schools were cluster randomized to an ER, BA or usual class control condition. Outcome measures included resilience, worry, anxiety, and depression symptomology; ER and BA were measured as potential mediators. Participants completed measures at pre- and postprogram, and at 6-month follow-up. RESULTS Children in the BA condition showed increased resilience at 6 months. Expressive suppression mediated the effects of both programs on worry. CONCLUSION The current study aimed to provide a preliminary evaluation of two universal school-based prevention programs, ER and BA, by increasing resilience to manage excessive worry, a transdiagnostic feature across anxiety and depression.",2020,"Expressive suppression mediated the effects of both programs on worry. ","['Primary school children (N\u2009=\u2009295; 52.5% female; 8-13 years) from five Australian schools', 'children']","['ER, BA or usual class control condition', 'universal school-based prevention programs, Emotion Regulation (ER) and Behavioral Activation (BA', 'universal school-based prevention programs']","['resilience, worry, anxiety, and depression symptomology; ER and BA', 'anxiety and depression symptomology']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0391913,"Expressive suppression mediated the effects of both programs on worry. ","[{'ForeName': 'Kristy M', 'Initials': 'KM', 'LastName': 'Johnstone', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Middleton', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kemps', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Research School of Psychology, Australian National University, Canberra, Australian Capital Territory, Australia.'}]",Journal of clinical psychology,['10.1002/jclp.22926'] 3537,31075675,Automated virtual reality exposure therapy for spider phobia vs. in-vivo one-session treatment: A randomized non-inferiority trial.,"OBJECTIVE This study compared the efficacy of a technician-assisted single-session virtual reality exposure therapy (VRET) for the treatment of spider phobia featuring low-cost consumer-available hardware and novel automated software to gold-standard in-vivo one-session treatment (OST), using a parallel group randomized non-inferiority design. Method Participants (N = 100) were randomized to VRET and OST arms. Assessors blinded to treatment allocation evaluated participants at pre- and post-treatment as well follow-up (3 and 12 months) using a behavioral approach test (BAT) and self-rated fear of spider, anxiety, depression and quality-of-life scales. A maximum post-treatment difference of 2-points on the BAT qualified as non-inferiority margin. Results Linear mixed models noted large, significant reductions in behavioral avoidance and self-reported fear in both groups at post-treatment, with VRET approaching the strong treatment benefits of OST over time. Non-inferiority was identified at 3- and 12- months follow-up but was significantly worse until 12-months. There was no significant difference on a questionnaire measuring negative effects. Conclusions Automated VRET efficaciously reduced spider phobia symptoms in the short-term and was non-inferior to in-vivo exposure therapy in the long-term. VRET effectiveness trials are warranted to evaluate real-world benefits and non-specific therapeutic factors accruing from the presence of a technician during treatment. ClinicalTrials.gov (NCT02533310).",2019,Non-inferiority was identified at 3- and 12- months follow-up but was significantly worse until 12-months.,['Method Participants (N\u202f=\u202f100'],"['technician-assisted single-session virtual reality exposure therapy (VRET', 'Automated virtual reality exposure therapy']","['spider phobia symptoms', 'behavioral avoidance and self-reported fear', 'behavioral approach test (BAT) and self-rated fear of spider, anxiety, depression and quality-of-life scales']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]","[{'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",100.0,0.154652,Non-inferiority was identified at 3- and 12- months follow-up but was significantly worse until 12-months.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Miloff', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden. Electronic address: alexander.miloff@psychology.su.se.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm County, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dafgård', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Deak', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Garke', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm County, Sweden.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hamilton', 'Affiliation': 'Mimerse AB, Stockholm, Sweden.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Heinsoo', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Kristoffersson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rafi', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Sindemark', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sjölund', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zenger', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Reuterskiöld', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm County, Sweden; Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden; Department of Psychology, University of Southern Denmark, Denmark.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.04.004'] 3538,31048096,A novel process-based approach to improve resilience: Effects of computerized mouse-based (gaze)contingent attention training (MCAT) on reappraisal and rumination.,"Stress dysregulation is a transdiagnostic marker of emotional disorders, related to biases in attention toward negative information. We adapted a computerized process-based training targeting these attention mechanisms through mouse-based contingency responses and examined its effects on reappraisal and rumination. Forty-one participants were randomly assigned to either a control or an active training condition of mouse-based contingent attention training (MCAT). Participants in the active condition were instructed to allocate attention toward positive words to generate positive interpretations, by using attention regulation while receiving contingent feedback on their attention to emotional words. Participants in the control condition freely generated interpretations without receiving contingent feedback. Transfer to reappraisal and state rumination was evaluated by administering an emotion regulation paradigm before and after the training. Mouse-based attention estimations showed a high degree of congruency with real eye/gaze-based attention estimations, as measured with eye-tracking performed in parallel. Furthermore, active MCAT resulted in several beneficial effects, including: 1) a higher attention toward positive over negative information; 2) an improved reappraisal ability to down-regulate negative emotions, and 3) a larger state rumination reduction in comparison to the control group. Our findings supports MCAT as a promising way to monitor and train attention, being an innovative instrument for online interventions aimed to improve stress regulation and resilience.",2019,Forty-one participants were randomly assigned to either a control or an active training condition of mouse-based contingent attention training (MCAT).,"['Participants in the active condition', 'Forty-one participants']","['MCAT', 'control or an active training condition of mouse-based contingent attention training (MCAT', 'computerized mouse-based (gaze)contingent attention training (MCAT', 'allocate attention toward positive words to generate positive interpretations, by using attention regulation while receiving contingent feedback on their attention to emotional words']","['Transfer to reappraisal and state rumination', 'state rumination reduction']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",41.0,0.0373805,Forty-one participants were randomly assigned to either a control or an active training condition of mouse-based contingent attention training (MCAT).,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Complutense University of Madrid, Spain; Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: alvsanch@ucm.es.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'van Put', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Ernst H W', 'Initials': 'EHW', 'LastName': 'Koster', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.04.005'] 3539,31892263,"Effect of a Comprehensive Health Care Program on Blood Pressure, Blood Glucose, Body Composition, and Depression in Older Adults Living Alone: A Quasi-Experimental Pretest-Posttest Study.","This study explored the effects of a comprehensive health-care program (CHCP) on blood pressure, blood glucose, body composition, and depression in older adults living alone. We used a quasi-experimental, two-group, pretest-posttest design. The CHCP consisted of open lectures, health counseling, exercise classes, nutrition counseling, and self-help group meetings at a local senior welfare center. Fifty-eight subjects participated in this study, with thirty subjects in the experimental group and twenty-eight subjects in the control group. Data were analyzed by using the descriptive statistics, χ 2 -test, and t -test. Comparisons of the pretest and posttest systolic blood pressure ( t = -2.530, p < 0.016) and blood glucose ( t = 3.089, p < 0.004) between the experimental and control groups showed significant differences. In both the experimental ( t = 3.949, p < 0.001) and control groups ( t = 3.816, p < 0.002), depression symptoms showed a significant decrease posttest, compared with pretest. Our findings infer that older adults require physical and psychosocial health care and that more efforts must be made to improve the general health and well-being of this population group.",2019,"In both the experimental ( t = 3.949, p < 0.001) and control groups ( t = 3.816, p < 0.002), depression symptoms showed a significant decrease posttest, compared with pretest.","['older adults living alone', 'Fifty-eight subjects participated in this study, with thirty subjects in the experimental group and twenty-eight subjects in the control group', 'Older Adults']","['Comprehensive Health Care Program', 'comprehensive health-care program (CHCP', 'health counseling, exercise classes, nutrition counseling, and self-help group meetings at a local senior welfare center']","['systolic blood pressure', 'blood glucose', 'blood pressure, blood glucose, body composition, and depression', 'Blood Pressure, Blood Glucose, Body Composition, and Depression', 'depression symptoms']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439044', 'cui_str': 'Lives alone (finding)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0454306', 'cui_str': 'Exercise class (regime/therapy)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",58.0,0.0110173,"In both the experimental ( t = 3.949, p < 0.001) and control groups ( t = 3.816, p < 0.002), depression symptoms showed a significant decrease posttest, compared with pretest.","[{'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing, Sehan University, Jeollanam-do 58447, Korea.'}, {'ForeName': 'In Ok', 'Initials': 'IO', 'LastName': 'Sim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17010220'] 3540,31707788,Effect of Alirocumab on Stroke in ODYSSEY OUTCOMES.,"BACKGROUND Lowering of atherogenic lipoproteins, including low-density lipoprotein cholesterol (LDL-C), reduces the risk of ischemic stroke. However, concerns have been raised about very low LDL-C levels and a potential increased risk of hemorrhagic stroke. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins, despite intensive statin therapy, targeting LDL-C levels of 25 to 50 mg/dL and avoiding sustained LDL-C <15 mg/dL. This prespecified analysis was designed to assess the effect of alirocumab on ischemic and hemorrhagic stroke. We hypothesized that for patients treated with alirocumab there would be a reduction in risk of ischemic stroke without increasing hemorrhagic stroke, irrespective of baseline LDL-C and of history of cerebrovascular disease. METHODS Patients were randomized to alirocumab or placebo 1 to 12 months after acute coronary syndrome. The risk of nonfatal or fatal ischemic or hemorrhagic stroke was evaluated, stratified by baseline LDL-C concentration and history of cerebrovascular disease. A potential association of very low achieved LDL-C with alirocumab treatment at month 4 and subsequent hemorrhagic stroke was assessed. RESULTS Median follow-up was 2.8 years. In total, 263 ischemic and 33 hemorrhagic strokes occurred. Alirocumab reduced the risk of any stroke (HR, 0.72 [95% CI, 0.57-0.91]) and ischemic stroke (HR, 0.73 [95% CI, 0.57-0.93]) without increasing hemorrhagic stroke (HR, 0.83 [95% CI, 0.42-1.65]). In total, 7164 (37.9%), 6128 (32.4%), and 5629 (29.7%) patients had a baseline LDL-C of <80, 80 to 100, and >100 mg/dL, respectively. The treatment effect on stroke appeared numerically greater for patients with higher baseline LDL-C, but there was no formal evidence of heterogeneity ( P interaction =0.31). The effect of alirocumab on stroke was similar among 944 patients (5.0%) with a history of previous cerebrovascular disease and among those without a history of cerebrovascular disease ( P interaction =0.37). There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. CONCLUSIONS In patients with recent acute coronary syndrome and dyslipidemia despite intensive statin therapy, alirocumab decreased the risk of stroke, irrespective of baseline LDL-C and history of cerebrovascular disease, over a median follow-up of 2.8 years. Furthermore, risk of hemorrhagic stroke did not depend on achieved LDL-C levels within the alirocumab group. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402.",2019,"There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. ","['patients with recent acute coronary syndrome and dyslipidemia despite intensive statin therapy', '18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins', '944 patients (5.0%) with a history of previous cerebrovascular disease and among those without a history of cerebrovascular disease ( P interaction =0.37', 'Patients']","['Alirocumab', 'alirocumab', 'placebo', 'alirocumab or placebo']","['stroke', 'risk of any stroke', 'risk of ischemic stroke', 'LDL-C levels', 'ischemic stroke', 'hemorrhagic stroke', 'risk of stroke, irrespective of baseline LDL-C and history of cerebrovascular disease', 'risk of nonfatal or fatal ischemic or hemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007820', 'cui_str': 'Intracranial Vascular Disorders'}, {'cui': 'C0585890', 'cui_str': 'History of cerebrovascular disease'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0585890', 'cui_str': 'History of cerebrovascular disease'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",944.0,0.370384,"There was no apparent adverse relation between lower achieved LDL-C and incidence of hemorrhagic stroke in the alirocumab group. ","[{'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands (J.W.J., L.E.Z.).'}, {'ForeName': 'Laurien E', 'Initials': 'LE', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands (J.W.J., L.E.Z.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts (D.L.B.).""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.).'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Drexel', 'Affiliation': 'Landeskrankenhaus Feldkirch, Austria (H.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'Sanofi, Paris, France (Y-U.K.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York (R.P.).'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'University Hospital Center Zagreb, School of Medicine, University of Zagreb, Croatia (Z.R.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina (M.T.R.).'}, {'ForeName': 'Hung-Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': 'Queen Mary Hospital, The University of Hong Kong (H-F.T.).'}, {'ForeName': 'Pablo Carlos', 'Initials': 'PC', 'LastName': 'Montenegro Valdovinos', 'Affiliation': 'Unidad de Diagnostico Cardiologico, Guatemala City, Guatemala (P.C.M.V.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand (H.D.W.).'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany (A.M.Z.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (G.G.S.).'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris (P.G.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.043826'] 3541,31140358,Embedding Self-Regulation Instruction Within Fractions Intervention for Third Graders With Mathematics Difficulties.,"The purpose of this study was to explore the efficacy of fractions intervention with and without an embedded self-regulation (SR) component for third-grade students at risk for mathematics disabilities. Fractions intervention focused on magnitude understanding and word problems. Embedded SR was designed to support a growth mindset (fostering belief that intellectual and academic abilities can be developed) along with SR processes in which students set goals, self-monitor, and use strategies to engage motivationally, metacognitively, and behaviorally through challenging tasks. Students ( n = 69) were randomly assigned to business-as-usual control and the two versions of fractions intervention. Multilevel models, accounting for the nested structure of the data, identified a moderation effect on fraction word problems: For students receiving fractions intervention with embedded SR, response to intervention was robust across the continuum of students' pretest word problem skill; by contrast, without SR, response to fractions intervention depended on students' pretest word problem skill. On the remaining outcomes, results reflected stronger outcomes when fractions intervention embedded SR instruction without moderation.",2019,"For students receiving fractions intervention with embedded SR, response to intervention was robust across the continuum of students' pretest word problem skill; by contrast, without SR, response to fractions intervention depended on students' pretest word problem skill.","['Students ( n = 69', 'Third Graders With Mathematics Difficulties', 'third-grade students at risk for mathematics disabilities']","['fractions intervention with and without an embedded self-regulation (SR) component', 'Fractions intervention', 'Embedding Self-Regulation Instruction', 'business-as-usual control and the two versions of fractions intervention']","['fraction word problems', 'magnitude understanding and word problems']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",69.0,0.0222581,"For students receiving fractions intervention with embedded SR, response to intervention was robust across the continuum of students' pretest word problem skill; by contrast, without SR, response to fractions intervention depended on students' pretest word problem skill.","[{'ForeName': 'Amber Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Fuchs', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Fuchs', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Gilbert', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Krowka', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Abramson', 'Affiliation': '1 Vanderbilt University, Nashville, TN, USA.'}]",Journal of learning disabilities,['10.1177/0022219419851750']